,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois
0,32340524,Positive Health Beliefs and Blood Pressure Reduction in the DESERVE Study.,"Background There is growing recognition that positive health beliefs may promote blood pressure (BP) reduction, which is critical to stroke prevention but remains a persistent challenge. Yet, studies that examine the association between positive health beliefs and BP among stroke survivors are lacking. Methods and Results Data came from the DESERVE (Discharge Educational Strategies for Reduction of Vascular Events) study, a randomized controlled trial of a skills-based behavioral intervention to reduce vascular risk in a multiethnic cohort of 552 transient ischemic attack and mild/moderate stroke patients in New York City. The exposure was perception that people can protect themselves from having a stroke (ie, prevention self-efficacy) at baseline. The association between systolic BP (SBP) reduction at 12-month follow-up and self-efficacy was examined using linear regression adjusted for key confounders, overall and stratified by age, sex, race/ethnicity, and intervention trial arm. Approximately three quarters endorsed self-efficacy. These participants had, on average, 5.6 mm Hg greater SBP reduction compared with those who did not endorse it (95% CI, 0.5-10.7 mm Hg;  P =0.032). Self-efficacy was significantly associated with greater SBP reduction, particularly among female versus male, younger versus older, and Hispanic versus non-Hispanic white patients. Sensitivity analysis adjusting for baseline SBP instead of elevated BP yielded no association between self-efficacy and SBP reduction, but showed sex differences in this association (women: β=5.3; 95% CI, -0.2 to 10.8;  P =0.057; men: β=-3.3; 95% CI, -9.4 to 2.9;  P =0.300; interaction  P =0.064). Conclusions Self-efficacy was linked with greater SBP reduction among female stroke survivors. Targeted strategies to improve health beliefs after stroke may be important for risk factor management. REGISTRATION URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT01836354.",2020,"Hg greater SBP reduction compared with those who did not endorse it (95% CI, 0.5-10.7 mm Hg;  P =0.032).","['female versus male, younger versus older, and Hispanic versus non-Hispanic white patients', 'multiethnic cohort of 552 transient ischemic attack and mild/moderate stroke patients in New York City', 'female stroke survivors', 'participants had, on average, 5.6\xa0mm']",['skills-based behavioral intervention'],"['blood pressure (BP) reduction', 'Positive Health Beliefs and Blood Pressure Reduction', 'self-efficacy and SBP reduction', 'vascular risk', 'systolic BP (SBP) reduction', 'SBP reduction', 'Self-efficacy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4517794', 'cui_str': '5.6'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0814098', 'cui_str': 'Health belief'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.111864,"Hg greater SBP reduction compared with those who did not endorse it (95% CI, 0.5-10.7 mm Hg;  P =0.032).","[{'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Goldmann', 'Affiliation': 'Department of Epidemiology School of Global Public Health New York University New York NY.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Jacoby', 'Affiliation': 'Department of Epidemiology School of Global Public Health New York University New York NY.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Finfer', 'Affiliation': 'Department of Epidemiology School of Global Public Health New York University New York NY.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Appleton', 'Affiliation': 'Department of Population Health New York University Langone Health New York NY.'}, {'ForeName': 'Nina S', 'Initials': 'NS', 'LastName': 'Parikh', 'Affiliation': 'Department of Social and Behavioral Sciences School of Global Public Health New York University New York NY.'}, {'ForeName': 'Eric T', 'Initials': 'ET', 'LastName': 'Roberts', 'Affiliation': 'Department of Epidemiology School of Global Public Health New York University New York NY.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Boden-Albala', 'Affiliation': 'Program in Public Health, Susan and Henry Samueli College of Health Sciences University of California, Irvine CA.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014782']
1,32340530,Cardiovascular Risk and Resilience Among Black Adults: Rationale and Design of the MECA Study.,"Background Cardiovascular disease incidence, prevalence, morbidity, and mortality have declined in the past several decades; however, disparities persist among subsets of the population. Notably, blacks have not experienced the same improvements on the whole as whites. Furthermore, frequent reports of relatively poorer health statistics among the black population have led to a broad assumption that black race reliably predicts relatively poorer health outcomes. However, substantial intraethnic and intraracial heterogeneity exists; moreover, individuals with similar risk factors and environmental exposures are often known to experience vastly different cardiovascular health outcomes. Thus, some individuals have good outcomes even in the presence of cardiovascular risk factors, a concept known as resilience. Methods and Results The MECA (Morehouse-Emory Center for Health Equity) Study was designed to investigate the multilevel exposures that contribute to ""resilience"" in the face of risk for poor cardiovascular health among blacks in the greater Atlanta, GA, metropolitan area. We used census tract data to determine ""at-risk"" and ""resilient"" neighborhoods with high or low prevalence of cardiovascular morbidity and mortality, based on cardiovascular death, hospitalization, and emergency department visits for blacks. More than 1400 individuals from these census tracts assented to demographic, health, and psychosocial questionnaires administered through telephone surveys. Afterwards, ≈500 individuals were recruited to enroll in a clinical study, where risk biomarkers, such as oxidative stress, and inflammatory markers, endothelial progenitor cells, metabolomic and microRNA profiles, and subclinical vascular dysfunction were measured. In addition, comprehensive behavioral questionnaires were collected and ideal cardiovascular health metrics were assessed using the American Heart Association's Life Simple 7 measure. Last, 150 individuals with low Life Simple 7 were recruited and randomized to a behavioral mobile health (eHealth) plus health coach or eHealth only intervention and followed up for improvement. Conclusions The MECA Study is investigating socioenvironmental and individual behavioral measures that promote resilience to cardiovascular disease in blacks by assessing biological, functional, and molecular mechanisms. REGISTRATION URL: https://www.clini​caltr​ials.gov. Unique identifier: NCT03308812.",2020,"Notably, blacks have not experienced the same improvements on the whole as whites.","['blacks in the greater Atlanta, GA, metropolitan area', 'Black Adults', '≈500 individuals', '150 individuals with low Life Simple 7 were recruited and randomized to a']",['behavioral mobile health (eHealth) plus health coach or eHealth only intervention'],"['oxidative stress, and inflammatory markers, endothelial progenitor cells, metabolomic and microRNA profiles, and subclinical vascular dysfunction', ' Cardiovascular disease incidence, prevalence, morbidity, and mortality', 'Cardiovascular Risk and Resilience']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0303134', 'cui_str': 'Beryllium-7'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}]",,0.0394992,"Notably, blacks have not experienced the same improvements on the whole as whites.","[{'ForeName': 'Shabatun J', 'Initials': 'SJ', 'LastName': 'Islam', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Jeong Hwan', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Topel', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': 'Department of Biostatistics and Bioinformatics Rollins School of Public Health Emory University Atlanta GA.'}, {'ForeName': 'Mahasin S', 'Initials': 'MS', 'LastName': 'Mujahid', 'Affiliation': 'Division of Epidemiology School of Public Health University of California Berkeley CA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Sims', 'Affiliation': 'Department of Medicine University of Mississippi Medical Center Jackson MS.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Mubasher', 'Affiliation': 'Department of Community Health and Preventive Medicine Morehouse School of Medicine Atlanta GA.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Ejaz', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Morgan-Billingslea', 'Affiliation': 'Department of Community Health and Preventive Medicine Morehouse School of Medicine Atlanta GA.'}, {'ForeName': 'Kia', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Edmund K', 'Initials': 'EK', 'LastName': 'Waller', 'Affiliation': 'Department of Hematology and Oncology Winship Cancer Institute Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Uppal', 'Affiliation': 'Division of Pulmonary, Allergy, Critical Care and Sleep Medicine Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Sandra B', 'Initials': 'SB', 'LastName': 'Dunbar', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing Emory University Atlanta GA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Pemu', 'Affiliation': 'Department of Medicine Morehouse School of Medicine Atlanta GA.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Vaccarino', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Searles', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Baltrus', 'Affiliation': 'Department of Community Health and Preventive Medicine Morehouse School of Medicine Atlanta GA.'}, {'ForeName': 'Tené T', 'Initials': 'TT', 'LastName': 'Lewis', 'Affiliation': 'Department of Epidemiology Rollins School of Public Health Emory University Atlanta GA.'}, {'ForeName': 'Arshed A', 'Initials': 'AA', 'LastName': 'Quyyumi', 'Affiliation': 'Division of Cardiology Department of Medicine Emory University School of Medicine Atlanta GA.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine Morehouse School of Medicine Atlanta GA.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015247']
2,32340597,Impact of Behavioral Health Homes on Cost and Utilization Outcomes.,"OBJECTIVE


This study evaluated the impact of two behavioral health home (BHH) approaches, provider-supported care and self-directed care, on health care utilization and cost outcomes among adult Medicaid recipients with serious mental illness.
METHODS


Eleven community mental health provider sites were randomly assigned to one of the BHH approaches, which each site implemented over a 2-year period. In both approaches, staff were trained in wellness coaching to support patients' progress toward general health and wellness goals. Provider-supported sites employed a full-time on-site registered nurse, who provided consultation to patients and wellness coaches. Each approach had a consistently enrolled treatment group (combined N=859) with a matched comparison cohort that was identified for analysis. Approaches were compared with each other and with baseline, and differences between each approach and its comparison cohort were examined by using analysis of covariance to determine impact on total health care cost, prescription costs, and use and cost of general medical and behavioral health services.
RESULTS


Relative to its comparison cohort, each approach achieved significant reductions in total cost (15% for provider-supported care and 26% for self-directed care) and increases in use of outpatient general medical services (43% for provider-supported care and 29% for self-directed care). Compared with self-directed care, provider-supported care resulted in approximately 28% lower use of general medical inpatient services and 26% lower related costs.
CONCLUSIONS


BHH approaches in community mental health settings can produce health care savings and decrease use of inpatient health care.",2020,"Compared with self-directed care, provider-supported care resulted in approximately 28% lower use of general medical inpatient services and 26% lower related costs.
","['Eleven community mental health provider sites', 'adult Medicaid recipients with serious mental illness']","['behavioral health home (BHH) approaches, provider-supported care and self-directed care']","['total cost', 'Cost and Utilization Outcomes', 'total health care cost, prescription costs, and use and cost of general medical and behavioral health services']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",11.0,0.0292273,"Compared with self-directed care, provider-supported care resulted in approximately 28% lower use of general medical inpatient services and 26% lower related costs.
","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Highland', 'Affiliation': 'BerryDunn, Portland, Maine (Highland), Phoenix (Ji), and Honolulu (Kukla); UPMC Center for High-Value Health Care (Nikolajski, Kogan) and Community Care Behavioral Health Organization (Schuster), UPMC Insurance Services Division, Pittsburgh.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Nikolajski', 'Affiliation': 'BerryDunn, Portland, Maine (Highland), Phoenix (Ji), and Honolulu (Kukla); UPMC Center for High-Value Health Care (Nikolajski, Kogan) and Community Care Behavioral Health Organization (Schuster), UPMC Insurance Services Division, Pittsburgh.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kogan', 'Affiliation': 'BerryDunn, Portland, Maine (Highland), Phoenix (Ji), and Honolulu (Kukla); UPMC Center for High-Value Health Care (Nikolajski, Kogan) and Community Care Behavioral Health Organization (Schuster), UPMC Insurance Services Division, Pittsburgh.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'BerryDunn, Portland, Maine (Highland), Phoenix (Ji), and Honolulu (Kukla); UPMC Center for High-Value Health Care (Nikolajski, Kogan) and Community Care Behavioral Health Organization (Schuster), UPMC Insurance Services Division, Pittsburgh.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Kukla', 'Affiliation': 'BerryDunn, Portland, Maine (Highland), Phoenix (Ji), and Honolulu (Kukla); UPMC Center for High-Value Health Care (Nikolajski, Kogan) and Community Care Behavioral Health Organization (Schuster), UPMC Insurance Services Division, Pittsburgh.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Schuster', 'Affiliation': 'BerryDunn, Portland, Maine (Highland), Phoenix (Ji), and Honolulu (Kukla); UPMC Center for High-Value Health Care (Nikolajski, Kogan) and Community Care Behavioral Health Organization (Schuster), UPMC Insurance Services Division, Pittsburgh.'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201900141']
3,32340693,"NeuroSAFE PROOF Randomised Controlled Feasibility Study: Brief Report of Perioperative Outcomes, Histological Concordance, and Feasibility.",,2020,,[],[],[],[],[],[],,0.0532683,,"[{'ForeName': 'Eoin', 'Initials': 'E', 'LastName': 'Dinneen', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK. Electronic address: eoin.dinneen@nhs.net.'}, {'ForeName': 'Aiman', 'Initials': 'A', 'LastName': 'Haider', 'Affiliation': 'Department of Histopathology, University College Hospitals London, London, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Freeman', 'Affiliation': 'Department of Histopathology, University College Hospitals London, London, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Oxley', 'Affiliation': 'Department of Histopathology, Southmead Hospital, North Bristol Hospitals Trust, Bristol, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Briggs', 'Affiliation': 'Department of Urology, Westmoreland Street Hospital, University College Hospitals London, London, UK.'}, {'ForeName': 'Senthil', 'Initials': 'S', 'LastName': 'Nathan', 'Affiliation': 'Department of Urology, Westmoreland Street Hospital, University College Hospitals London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK; Department of Urology, Westmoreland Street Hospital, University College Hospitals London, London, UK.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Grierson', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Allen', 'Affiliation': 'Department of Uro-radiology, Westmoreland Street Hospital, University College Hospitals London, London, UK.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Persad', 'Affiliation': 'Department of Urology, Southmead Hospital, North Bristol Hospitals Trust, Bristol, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Aning', 'Affiliation': 'Department of Urology, Southmead Hospital, North Bristol Hospitals Trust, Bristol, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Oakley', 'Affiliation': 'Department of Urology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ahmad', 'Affiliation': 'Department of Urology, Queen Elizabeth University Hospital, Glasgow & Clyde NHS Trust, Glasgow, UK.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Dutto', 'Affiliation': 'Department of Urology, Queen Elizabeth University Hospital, Glasgow & Clyde NHS Trust, Glasgow, UK.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Shaw', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, UK; Department of Urology, Westmoreland Street Hospital, University College Hospitals London, London, UK.'}]",European urology,['10.1016/j.eururo.2020.03.052']
4,32341113,"Minimal clinically important differences in average, best, worst and current intensity and unpleasantness of chronic breathlessness.","BACKGROUND


Chronic breathlessness has devastating consequences. The minimal clinically important difference (MCID) for current intensity has been estimated as 9 mm on a 100-mm visual analogue scale (VAS). We aimed to determine MCIDs for commonly used dimensions and recall periods: the current unpleasantness and current, average, best and worst intensity of the past 24 h for chronic breathlessness.
METHODS


This was a secondary analysis of a randomised controlled trial of morphine  versus  placebo over 7 days in people with chronic breathlessness from severe disease. The breathlessness scores were self-reported using a diary each evening on 100-mm VAS. The MCID for improvement in each score was estimated using anchor-based and distribution-based methods.
RESULTS


283 participants (mean age 74.2 years; 63% male; 58% COPD; 87.0% modified Medical Research Council (mMRC) score 3-4) were included. Anchor-based MCIDs for breathlessness scores ranged from -13.9 mm to -9.5 mm. The MCIDs were similar when using different anchors and across all participants, and participants with more severe breathlessness (mMRC 3-4). Distribution-based effect sizes were classed as small (-4.7-6.3 mm), moderate (-9.4-12.5 mm) and large (-15.0-20.0 mm) effect. Sample sizes for trials using the different scores were proposed. MCIDs of absolute change were more stable than using relative change from baseline.
CONCLUSION


An improvement of ∼10 mm on a 100-mm VAS is likely to be clinically meaningful across commonly used measures of chronic breathlessness (current intensity, unpleasantness, and average, best and worst intensity over the past 24 h) to evaluate clinical benefit and effects in therapeutic trials.",2020,"The MCIDs were similar when using different anchors and across all participants, and participants with more severe BREATHLESSNESS (mMRC 3-4), respectively.","['283 participants (mean age 74.2\u2005years; 63% males; 58% COPD; 87.0', 'people with chronic breathlessness from severe disease']",['morphine  versus  placebo'],"['average, best, worst and current intensity and unpleasantness of chronic breathlessness', 'breathlessness scores']","[{'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",4.0,0.214139,"The MCIDs were similar when using different anchors and across all participants, and participants with more severe BREATHLESSNESS (mMRC 3-4), respectively.","[{'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekström', 'Affiliation': 'Dept of Clinical Sciences, Division of Respiratory Medicine and Allergology, Lund University, Lund, Sweden pmekstrom@gmail.com.'}, {'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Johnson', 'Affiliation': 'Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, UK.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Currow', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, Australia.'}]",The European respiratory journal,['10.1183/13993003.02202-2019']
5,32341291,Test-Retest Reliability and the Effects of Exercise on the King-Devick Test.,"OBJECTIVE


To determine the test-retest reliability and the influence of exercise on King-Devick (K-D) test performance.
DESIGN


Crossover study design.
SETTING


Controlled laboratory.
PARTICIPANTS


Participants consisted of 63 (39 women and 24 men) healthy, recreationally active college students who were 21.0 + 1.5 years of age.
INDEPENDENT VARIABLES


Participants completed the K-D test using a 2-week, test-retest interval. The K-D test was administered before and after a counterbalanced exercise or rest intervention. Reliability was assessed using testing visits (visit 1 and visit 2) as the independent variables. Exercise or rest and time (baseline, postintervention) were used as independent variables to examine the influence of exercise.
MAIN OUTCOME MEASURES


Intraclass correlation (ICC) coefficients with 95% confidence intervals were calculated between visits to assess reliability of K-D test completion time. A repeated-measure 2 x 2 analysis of variance (intervention × time) with post hoc paired t tests was used to assess the influence of exercise on K-D test performance.
RESULTS


The K-D test was observed to have strong test-retest reliability [ICC2,1 = 0.90 (0.71, 0.96)] over time. No significant intervention-by-time interaction (P = 0.55) or intervention main effects (P = 0.68) on K-D time were observed. Mean differences of -1.5 and -1.7 seconds (P < 0.001) were observed between baseline and rest and exercise interventions for K-D test performance, respectively. Up to 32% (20/63) of participants were observed to have a false-positive K-D test performance before and after each intervention.
CONCLUSIONS


Although strong test-retest reliability coefficients were observed using clinically relevant time points, a high false-positive rate warrants caution when interpreting the K-D test.",2020,"Up to 32% (20/63) of participants were observed to have a false-positive K-D test performance before and after each intervention.
","['Participants consisted of 63 (39 women and 24 men) healthy, recreationally active college students who were 21.0 + 1.5 years of age']",['counterbalanced exercise or rest intervention'],"['Reliability', 'Exercise or rest and time (baseline, postintervention', 'K-D time', 'false-positive K-D test performance', 'King-Devick (K-D) test performance']","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C4759290', 'cui_str': 'King-Devick test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",,0.088008,"Up to 32% (20/63) of participants were observed to have a false-positive K-D test performance before and after each intervention.
","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Eddy', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Goetschius', 'Affiliation': 'Department of Exercise Science and Athletic Training, Adrian College, Adrian, Michigan.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Hertel', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Resch', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, Virginia.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000586']
6,32342247,Investigation of fluctuations in blood glucose level due to dietary restrictions during impacted mandibular third molar extraction under intravenous sedation: effect of perioperative glucose administration.,"OBJECTIVE


We aimed to investigate the usefulness of glucose administration for maintaining perioperative glycemic control in patients with dietary restrictions during 4 h prior to impacted mandibular third molar extraction under intravenous sedation.
METHODS


Fifty-four individuals scheduled to undergo extraction of impacted mandibular third molars under intravenous sedation, with preoperative blood glucose levels (GL) of 70-110 mg/dL, were evaluated and divided into 3 groups (n = 18 each): control group receiving glucose-free sodium lactate Ringer's solution, perioperative GL group receiving 100 mL of 5% glucose solution immediately after local anesthesia, and postoperative GL group receiving 100 mL of 5% glucose solution immediately after surgery completion. Blood glucose levels, systolic blood pressure, diastolic blood pressure, and heart rate were measured.
RESULTS


Glucose levels of those in the control and perioperative GL groups decreased within the standard range 90 min after surgery, compared with the preoperative blood glucose level. However, in the postoperative GL group, glucose levels were similar to the preoperative levels. Systolic and diastolic blood pressure and heart rate were not affected by glucose administration, and sedation could be maintained without an invasive procedure.
CONCLUSIONS


Following a restriction on eating and drinking 4 h prior to surgery, the blood glucose level gradually decreased in the perioperative period but remained within the reference range until 90 min following surgery. The administration of 100 mL 5% glucose solution immediately after surgery was sufficient for the prevention of postoperative hypoglycemia. This approach may be useful for perioperative glycemic control during third molar extraction.",2020,"RESULTS


Glucose levels of those in the control and perioperative GL groups decreased within the standard range 90 min after surgery, compared with the preoperative blood glucose level.","['Fifty-four individuals scheduled to undergo extraction of impacted mandibular third molars under intravenous sedation, with preoperative blood glucose levels (GL) of 70-110\xa0mg/dL, were evaluated and divided into 3 groups (n\u2009=\u200918 each', 'patients with dietary restrictions during 4\xa0h prior to impacted mandibular third molar extraction under intravenous sedation']","['glucose administration', ""control group receiving glucose-free sodium lactate Ringer's solution, perioperative GL group receiving 100\xa0mL of 5% glucose solution immediately after local anesthesia, and postoperative GL group receiving 100\xa0mL of 5% glucose solution""]","['blood glucose level', 'glucose levels', 'Systolic and diastolic blood pressure and heart rate', 'Blood glucose levels, systolic blood pressure, diastolic blood pressure, and heart rate', 'preoperative blood glucose level', 'Glucose levels']","[{'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0412775', 'cui_str': 'Intravenous sedation'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0142874', 'cui_str': 'Sodium lactate'}, {'cui': 'C0073386', 'cui_str': 'Ringers Solution'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]",54.0,0.0361795,"RESULTS


Glucose levels of those in the control and perioperative GL groups decreased within the standard range 90 min after surgery, compared with the preoperative blood glucose level.","[{'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Sekine', 'Affiliation': 'Anesthesiology and Resuscitation, The Nippon Dental University Graduate School of Life Dentistry at Niigata, Niigata, Japan. mi0@ngt.ndu.ac.jp.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Department of Dental Anesthesiology, The Nippon Dental University School of Life Dentistry at Niigata, 1-8 Hamauracho Chuoku, Niigata, 951-8580, Japan.'}, {'ForeName': 'Asami', 'Initials': 'A', 'LastName': 'Iguchi', 'Affiliation': 'Department of Dental Anesthesiology, The Nippon Dental University School of Life Dentistry at Niigata, 1-8 Hamauracho Chuoku, Niigata, 951-8580, Japan.'}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Fujii', 'Affiliation': 'Anesthesiology and Resuscitation, The Nippon Dental University Graduate School of Life Dentistry at Niigata, Niigata, Japan.'}]",Oral and maxillofacial surgery,['10.1007/s10006-020-00843-w']
7,32281738,"Identifying Cranberry Juice Consumers with Predictive OPLS-DA Models of Plasma Metabolome and Validation of Cranberry Juice Intake Biomarkers in a Double-Blinded, Randomized, Placebo-Controlled, Cross-Over Study.","SCOPE


Methods to verify cranberry juice consumption are lacking. Predictive multivariate models built upon validated biomarkers may help to verify human consumption of a food using a nutrimetabolomics approach.
METHODS


A 21-day double-blinded, randomized, placebo-controlled, cross-over study was conducted among healthy young women aged 1829. Plasma was collected at baseline and after 3-day and 21-day consumption of cranberry or placebo juice. Plasma metabolome was analyzed using UHPLC coupled with high resolution mass spectrometry.
RESULTS


18 discriminant metabolites in positive mode and 18 discriminant metabolites in negative mode from a previous 3-day open-label study were re-discovered in the present blinded study. Predictive orthogonal partial least squares discriminant analysis (OPLS-DA) models were able to identify cranberry juice consumers over a placebo juice group with 96.9% correction rates after 3-day consumption in both positive and negative mode. This present study revealed 84 and 109 additional discriminant metabolites in positive and negative mode, respectively. Twelve of them were tentatively identified.
CONCLUSION


Cranberry juice consumers were classified with high correction rates using predictive OPLS-DA models built upon validated plasma biomarkers. Additional biomarkers were tentatively identified. These OPLS-DA models and biomarkers provided an objective approach to verify participant compliance in future clinical trials.",2020,The models were able to identify cranberry juice consumers over placebo juice group with 96.9% correction rates after 3-day consumption at both positive and negative mode.,['healthy young women aging 18-29'],"['placebo juice', 'cranberry or placebo juice', 'placebo']",['Plasma metabolome'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}]",,0.38251,The models were able to identify cranberry juice consumers over placebo juice group with 96.9% correction rates after 3-day consumption at both positive and negative mode.,"[{'ForeName': 'Shaomin', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Food Science and Human Nutrition Department, Institute of Food and Agricultural Sciences, University of Florida, Gainesville, FL, 32611, USA.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Ocean Spray Cranberries, Inc., Lakeville-Middleboro, MA, 02349, USA.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Su', 'Affiliation': 'Department of Statistics, College of Liberal Arts and Sciences, University of Florida, Gainesville, FL, 32611, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Khoo', 'Affiliation': 'Ocean Spray Cranberries, Inc., Lakeville-Middleboro, MA, 02349, USA.'}, {'ForeName': 'Liwei', 'Initials': 'L', 'LastName': 'Gu', 'Affiliation': 'Food Science and Human Nutrition Department, Institute of Food and Agricultural Sciences, University of Florida, Gainesville, FL, 32611, USA.'}]",Molecular nutrition & food research,['10.1002/mnfr.201901242']
8,31799875,Assessment of Response to Neoadjuvant Therapy Using CT Texture Analysis in Patients With Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma.,"OBJECTIVE.  The goal of this study was to assess the correlation between CT-derived texture features of pancreatic ductal adenocarcinoma (PDAC) and histologic and biochemical markers of response to neoadjuvant treatment as well as disease-free survival in patients with potentially resectable PDAC.  SUBJECTS AND METHODS.  Thirty-nine patients completed this prospective study protocol between November 2013 and December 2016. All patients received neoadjuvant chemotherapy, underwent surgical resection, and had histologic grading of tumor response. Similar CT protocol was used for all patients. Pancreatic (late arterial) phase of pre- and posttreatment CT scans were evaluated. Histogram analysis and spatial-band-pass filtration were used to extract textural features. Correlation between textural parameters, histologic response, biochemical response, and genetic mutations was assessed using Mann-Whitney test, chi-square analysis, and multivariate logistic regression. Association with disease-free survival was assessed using Kaplan-Meier method and Cox model.  RESULTS.  Pretreatment mean positive pixel (MPP) at fine- and medium-level filtration, pretreatment kurtosis at medium-level filtration, changes in kurtosis, and pretreatment tumor SD were statistically different between patients with no or poor histologic response and favorable histologic response ( p  < 0.05). Changes in skewness and kurtosis at medium-level filtration significantly correlated with biochemical response ( p  < 0.01). On the basis of multivariate analysis, patients with higher MPP at pretreatment CT were more likely to have favorable histologic response (odds ratio, 1.06; 95% CI, 1.002-1.12). The Cox model for association between textural features and disease-free survival was statistically significant ( p  = 0.001).  CONCLUSION.  Textural features extracted from baseline pancreatic phase CT imaging of patients with potentially resectable PDAC and longitudinal changes in tumor heterogeneity can be used as biomarkers for predicting histologic response to neoadjuvant chemotherapy and disease-free survival.",2020,Changes in skewness and kurtosis at medium-level filtration significantly correlated with biochemical response ( p  < 0.01).,"['Patients With Resectable and Borderline Resectable Pancreatic Ductal Adenocarcinoma', 'patients with potentially resectable PDAC', 'Thirty-nine patients completed this prospective study protocol between November 2013 and December 2016']","['neoadjuvant chemotherapy, underwent surgical resection', 'Neoadjuvant Therapy Using CT Texture Analysis']","['textural parameters, histologic response, biochemical response, and genetic mutations', 'histologic response and favorable histologic response', 'Pretreatment mean positive pixel (MPP) at fine- and medium-level filtration, pretreatment kurtosis at medium-level filtration, changes in kurtosis, and pretreatment tumor SD', 'textural features and disease-free survival', 'favorable histologic response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C1832661', 'cui_str': 'Matthew Wood syndrome'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016107', 'cui_str': 'Filtration'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",,0.0270394,Changes in skewness and kurtosis at medium-level filtration significantly correlated with biochemical response ( p  < 0.01).,"[{'ForeName': 'Amir A', 'Initials': 'AA', 'LastName': 'Borhani', 'Affiliation': 'Department of Radiology, Division of Abdominal Imaging, University of Pittsburgh Medical Center, Ste 200 E Wing, 200 Lothrop St, Pittsburgh, PA 15213.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Dewan', 'Affiliation': 'Department of Radiology, Division of Abdominal Imaging, University of Pittsburgh Medical Center, Ste 200 E Wing, 200 Lothrop St, Pittsburgh, PA 15213.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Furlan', 'Affiliation': 'Department of Radiology, Division of Abdominal Imaging, University of Pittsburgh Medical Center, Ste 200 E Wing, 200 Lothrop St, Pittsburgh, PA 15213.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Seiser', 'Affiliation': 'Department of Surgery, Division of Gastrointestinal Surgical Oncology, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Amer H', 'Initials': 'AH', 'LastName': 'Zureikat', 'Affiliation': 'Department of Surgery, Division of Gastrointestinal Surgical Oncology, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Aatur D', 'Initials': 'AD', 'LastName': 'Singhi', 'Affiliation': 'Department of Pathology, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Boone', 'Affiliation': 'Department of Surgery, Division of Gastrointestinal Surgical Oncology, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Bahary', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Melissa E', 'Initials': 'ME', 'LastName': 'Hogg', 'Affiliation': 'Department of Surgery, Division of Gastrointestinal Surgical Oncology, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lotze', 'Affiliation': 'Department of Surgery, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Herbert J', 'Initials': 'HJ', 'LastName': 'Zeh', 'Affiliation': 'Department of Surgery, Division of Gastrointestinal Surgical Oncology, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Mitchell E', 'Initials': 'ME', 'LastName': 'Tublin', 'Affiliation': 'Department of Radiology, Division of Abdominal Imaging, University of Pittsburgh Medical Center, Ste 200 E Wing, 200 Lothrop St, Pittsburgh, PA 15213.'}]",AJR. American journal of roentgenology,['10.2214/AJR.19.21152']
9,32347208,"Yoga improves balance, mobility, and perceived occupational performance in adults with chronic brain injury: A preliminary investigation.","BACKGROUND AND PURPOSE


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


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


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


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


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


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


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


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


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


Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05).
","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Latifi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran. Electronic address: latifizh@gmail.com.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Soltani', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}, {'ForeName': 'Shokoufeh', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101180']
11,32347414,Predictors of Research Assessment Completion in a Latino Sample with Dual Disorders.,"Latinos are underrepresented in clinical trials, where they encounter challenges in participation and a lack of effective recruitment and retention strategies. For Latino migrants with mental health and substance use problems, these challenges are even greater. Analyzing results from a multicenter randomized clinical trial for Latino migrants with mental health and substance use problems in Boston, Massachusetts, USA as well as Madrid and Barcelona, Spain, we describe six retention strategies used to facilitate participant engagement in follow-up assessments, and report the sociodemographic, clinical, and educational factors associated with research assessment completion. Among 341 randomized participants, 77% completed the 12-month follow-up and 75% completed at least 3 of the 4 follow-up assessments. Having a high school diploma, being recruited at community centers versus other sites, and having a less severe mental health condition were significantly associated with completing more follow-up interviews. Rigorous and customized methods reflecting participant's individual context can bolster research assessment completion for diverse Latino populations with behavioral health concerns.",2020,"Among 341 randomized participants, 77% completed the 12-month follow-up and 75% completed at least 3 of the 4 follow-up assessments.","['Latino Sample with Dual Disorders', 'diverse Latino populations with behavioral health concerns', 'Latino migrants with mental health and substance use problems in Boston, Massachusetts, USA as well as Madrid and Barcelona, Spain']",[],['severe mental health condition'],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0026093', 'cui_str': 'Migrant'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",341.0,0.068088,"Among 341 randomized participants, 77% completed the 12-month follow-up and 75% completed at least 3 of the 4 follow-up assessments.","[{'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Herrera', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Sheri Lapatin', 'Initials': 'SL', 'LastName': 'Markle', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Fukuda', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Aroca', 'Affiliation': 'Department of Psychiatry, Instituto de Investigación Sanitaria, Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Villar', 'Affiliation': ""Department of Psychiatry, Hospital Universitari Vall D'Hebron, Barcelona, Spain.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Dominique', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Umoren', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Alegría', 'Affiliation': 'Disparities Research Unit, Department of Medicine, Massachusetts General Hospital, 50 Staniford Street, Suite 830, Boston, MA, 02114, USA. malegria@mgh.harvard.edu.'}]",Journal of immigrant and minority health,['10.1007/s10903-020-01010-9']
12,32347695,Comparison of clinical outcomes between vector planning and manifest refraction planning in SMILE for myopic astigmatism.,"PURPOSE


To compare clinical outcomes of small-incision lenticule extraction (SMILE) between manifest refraction (MR) and vector planning for myopic astigmatism with high ocular residual astigmatism (ORA).
SETTING


Yonsei University College of Medicine and Eyereum Eye Clinic, Seoul, South Korea.
DESIGN


Prospective, randomized, comparative case series.
METHODS


Patients with myopic astigmatism and ORA of 0.75 diopters (D) or greater were randomized into the MR or vector planning group and underwent SMILE without applying any nomogram for cylinder correction. Visual acuity, MR, corneal topography, and corneal aberration were measured preoperatively and postoperatively. Outcomes at 6 months postoperatively were compared between the groups.
RESULTS


The study comprised 114 patients (114 eyes): 58 eyes in MR planning and 56 eyes in vector planning. The mean uncorrected and corrected distance visual acuity, safety and efficacy indices were comparable between the 2 groups. Postoperative refractive cylinder reached statistically significant differences between the groups (-0.22 ± 0.18 D and -0.14 ± 0.16 D in the MR and vector planning groups, respectively, P = .02). Postoperative corneal toricity and ORA reached statistically significant lower in the vector planning group.
CONCLUSIONS


In myopic astigmatism with high ORA, MR and vector planning in SMILE were effective with comparable visual outcomes; vector planning showed statistically significant lower postoperative refractive and corneal astigmatism and ORA. Use of vector planning may improve refractive outcomes in SMILE cases with high ORA. However, the results may have been different had a nomogram adjustment been applied, as is often used for cylinder corrections with SMILE.",2020,"The mean uncorrected and corrected distance visual acuity, safety and efficacy indices, and aberrometric values were comparable between the two groups at 6 months after SMILE.","[' We included 114 eyes of 114 patients with myopic astigmatism and ORA ≥ 0.75 diopters (D); patients underwent SMILE', 'myopic astigmatism with high ocular residual astigmatism (ORA', 'small incision lenticule extraction for myopic astigmatism', 'SMILE cases with high ORA', 'Yonsei University College of Medicine and Eyereum Eye Clinic, Seoul, Korea DESIGN']","['manifest refraction planning (58 eyes) or vector planning', 'vector planning', 'small incision lenticule extraction (SMILE', 'Vector Planning and manifest refraction planning']","['ORA', 'Postoperative refractive cylinder', 'Postoperative corneal toricity', 'refractive outcomes', 'mean uncorrected and corrected distance visual acuity, safety and efficacy indices, and aberrometric values', 'Visual acuity, manifest refraction, corneal topography, and corneal aberration', 'postoperative refractive and corneal astigmatism, and ORA']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2363771', 'cui_str': 'Myopic astigmatism'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3203722', 'cui_str': 'Residual astigmatism'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C3203722', 'cui_str': 'Residual astigmatism'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1301318', 'cui_str': 'Subjective refraction'}, {'cui': 'C0524957', 'cui_str': 'Corneal topography'}, {'cui': 'C0339682', 'cui_str': 'Regular astigmatism - corneal'}]",114.0,0.0381255,"The mean uncorrected and corrected distance visual acuity, safety and efficacy indices, and aberrometric values were comparable between the two groups at 6 months after SMILE.","[{'ForeName': 'Ikhyun', 'Initials': 'I', 'LastName': 'Jun', 'Affiliation': ""From the Department of Ophthalmology (Jun, E. K. Kim, Seo, Lee, T.-i. Kim), The Institute of Vision Research, Department of Ophthalmology (Jun, E.K. Kim, T.-i. Kim), Corneal Dystrophy Research Institute, Yonsei University College of Medicine, Eyereum Eye Clinic (Kang, Jean), Seoul, South Korea; Research and Development (Arba-Mosquera), Biomedical Engineering Office, SCHWIND eye-tech-solutions, Kleinostheim, Germany; London Vision Clinic (Reinstein, Archer), London, United Kingdom; Department of Ophthalmology (Reinstein), Columbia University Medical Center, New York, NY, USA; Centre Hospitalier National d'Ophtalmologie (Reinstein), Paris, France; Biomedical Science Research Institute, University of Ulster (Reinstein, Archer), Coleraine, Northern Ireland.""}, {'ForeName': 'David Sung Yong', 'Initials': 'DSY', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Arba-Mosquera', 'Affiliation': ''}, {'ForeName': 'Dan Z', 'Initials': 'DZ', 'LastName': 'Reinstein', 'Affiliation': ''}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Archer', 'Affiliation': ''}, {'ForeName': 'Seung Ki', 'Initials': 'SK', 'LastName': 'Jean', 'Affiliation': ''}, {'ForeName': 'Eung Kweon', 'Initials': 'EK', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Kyoung Yul', 'Initials': 'KY', 'LastName': 'Seo', 'Affiliation': ''}, {'ForeName': 'Hyung Keun', 'Initials': 'HK', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Tae-Im', 'Initials': 'TI', 'LastName': 'Kim', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000100']
13,32347799,The Effect of Shame on Patients With Social Anxiety Disorder in Internet-Based Cognitive Behavioral Therapy: Randomized Controlled Trial.,"BACKGROUND


Prior research has demonstrated the efficacy of internet-based cognitive behavioral therapy (ICBT) for social anxiety disorder (SAD). However, it is unclear how shame influences the efficacy of this treatment.
OBJECTIVE


This study aimed to investigate the role shame played in the ICBT treatment process for participants with SAD.
METHODS


A total of 104 Chinese participants (73 females; age: mean 24.92, SD 4.59 years) were randomly assigned to self-help ICBT, guided ICBT, or wait list control groups. For the guided ICBT group, half of the participants were assigned to the group at a time due to resource constraints. This led to a time difference among the three groups. Participants were assessed before and immediately after the intervention using the Social Interaction Anxiety Scale (SIAS), Social Phobia Scale (SPS), and Experience of Shame Scale (ESS).
RESULTS


Participants' social anxiety symptoms (self-help: differences between pre- and posttreatment SIAS=-12.71; Cohen d=1.01; 95% CI 9.08 to 16.32; P<.001 and differences between pre- and posttreatment SPS=11.13; Cohen d=0.89; 95% CI 6.98 to 15.28; P<.001; guided: SIAS=19.45; Cohen d=1.20; 95% CI 14.67 to 24.24; P<.001 and SPS=13.45; Cohen d=0.96; 95% CI 8.26 to 18.64; P<.001) and shame proneness (self-help: differences between pre- and posttreatment ESS=7.34; Cohen d=0.75; 95% CI 3.99 to 10.69; P<.001 and guided: differences between pre- and posttreatment ESS=9.97; Cohen d=0.88; 95% CI 5.36 to 14.57; P<.001) in both the self-help and guided ICBT groups reduced significantly after treatment, with no significant differences between the two intervention groups. Across all the ICBT sessions, the only significant predictors of reductions in shame proneness were the average number of words participants wrote in the exposure module (β=.222; SE 0.175; t 96 =2.317; P=.02) and gender (β=-.33; SE 0.002; t 77 =-3.13; P=.002). We also found a mediation effect, wherein reductions in shame fully mediated the relationship between the average number of words participants wrote in the exposure module and reductions in social anxiety symptoms (SIAS: β=-.0049; SE 0.0016; 95% CI -0.0085 to -0.0019 and SPS: β=-.0039; SE 0.0015; 95% CI -0.0075 to -0.0012).
CONCLUSIONS


The findings of this study suggest that participants' engagement in the exposure module in ICBT alleviates social anxiety symptoms by reducing the levels of shame proneness. Our study provides a new perspective for understanding the role of shame in the treatment of social anxiety. The possible mechanisms of the mediation effect and clinical implications are discussed.
TRIAL REGISTRATION


Chinese Clinical Trial Registry ChiCTR1900021952; http://www.chictr.org.cn/showproj.aspx?proj=36977.",2020,"Participants were assessed before and immediately after the intervention using Social Interaction Anxiety Scale (SIAS), Social Phobia Scale (SPS), and Experience of Shame Scale (ESS).
","['104 Chinese participants (73 females; age: mean 24.92 years, SD 4.59', 'Patients With Social Anxiety Disorder in Internet-Based', 'participants with SAD.\nMETHODS']","['ICBT', 'internet-based cognitive behavioral therapy (ICBT', 'Cognitive Behavioral Therapy']","['social anxiety symptoms', 'shame proneness', 'Social Interaction Anxiety Scale (SIAS), Social Phobia Scale (SPS), and Experience of Shame Scale (ESS', 'ICBT alleviates social anxiety symptoms']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",104.0,0.0369145,"Participants were assessed before and immediately after the intervention using Social Interaction Anxiety Scale (SIAS), Social Phobia Scale (SPS), and Experience of Shame Scale (ESS).
","[{'ForeName': 'Haoyu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'School of Psychological and Cognitive Sciences, Peking University, Beijing, China.'}, {'ForeName': 'Qingxue', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'School of Psychological and Cognitive Sciences, Peking University, Beijing, China.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Mu', 'Affiliation': 'Center for the Treatment and Study of Anxiety, University of Pennsylvania, Pennsylvania, PA, United States.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychology, Pitzer College, California, CA, United States.'}, {'ForeName': 'Mingyi', 'Initials': 'M', 'LastName': 'Qian', 'Affiliation': 'School of Psychological and Cognitive Sciences, Peking University, Beijing, China.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}]",JMIR mental health,['10.2196/15797']
14,32343960,"JNJ-56136379, an HBV Capsid Assembly Modulator, Is Well-Tolerated and Has Antiviral Activity in a Phase 1 Study of Patients With Chronic Infection.","BACKGROUND & AIMS


JNJ-56136379 (JNJ-6379), a capsid assembly modulator that blocks hepatitis B virus (HBV) replication, was well tolerated and demonstrated dose-proportional pharmacokinetics in healthy participants in part 1 of its first clinical trial. In part 2, we have evaluated the safety, pharmacokinetics, and antiviral activity of multiple doses of JNJ-6379 in patients with chronic HBV infection.
METHODS


We performed a double-blind study of 57 treatment-naïve patients with HB e antigen-positive or -negative (74%) chronic HBV infection without cirrhosis. Patients were randomly assigned to groups given JNJ-6379 at 25 mg (100 mg loading dose), 75 mg, 150 mg, or 250 mg or placebo daily for 4 weeks with an 8-week follow-up period.
RESULTS


Twenty-three (56%) of 41 patients given JNJ-6379 had at least 1 adverse event (AE) during treatment, compared with 10 (63%) of 16 patients given placebo. No serious AEs were reported during the treatment period. Three patients (7%) given JNJ-6379 vs none given placebo had grade 3 AEs; of these, 1 patient (150 mg) also had an isolated grade 4 increase in the level of alanine aminotransferase that led to treatment discontinuation. JNJ-6379 exposure increased with dose, with time-linear pharmacokinetics. HBV-DNA and HBV-RNA decreased from baseline in patients receiving all doses of JNJ-6379, independently of viral genotype and HB e antigen status. On day 29, 13 (32%) of 41 patients had levels of HBV DNA below the lower limit of quantification. No clinically significant changes in levels of HB surface antigen were observed.
CONCLUSIONS


In a phase 1 study of treatment-naïve patients with chronic HBV infection, all doses tested of JNJ-6379 were well tolerated, showed dose-dependent pharmacokinetics, and had potent antiviral activity in patients with CHB. The findings support a phase 2a study to evaluate JNJ-6379 ± nucleos(t)ide analogs in patients with chronic HBV infection, which is under way. ClinicalTrials.gov identifier: NCT02662712.",2020,"HBV-DNA and HBV-RNA decreased from baseline in patients receiving all doses of JNJ-6379, independently of viral genotype and HB e antigen status.","['Patients with Chronic Infection', 'patients with CHB', 'patients with chronic HBV infection', 'healthy participants', '57 treatment-naïve patients with HB e antigen-positive or -negative (74%) chronic HBV infection without cirrhosis']","['JNJ-6379', 'placebo']","['levels of HBV DNA', 'level of alanine aminotransferase', 'HBV-DNA and HBV-RNA', 'safety, pharmacokinetics, and antiviral activity', 'levels of HB surface antigen']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0151317', 'cui_str': 'Chronic infectious disease'}, {'cui': 'C0151517', 'cui_str': 'Complete atrioventricular block'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0003339', 'cui_str': 'Surface Antigens'}]",,0.0672743,"HBV-DNA and HBV-RNA decreased from baseline in patients receiving all doses of JNJ-6379, independently of viral genotype and HB e antigen status.","[{'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Zoulim', 'Affiliation': 'Hepatology Unit, Hospices Civils de Lyon and Lyon University, Lyon, France; INSERM U1052-Cancer Research Institute of Lyon, Lyon, France. Electronic address: fabien.zoulim@chu-lyon.fr.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Lenz', 'Affiliation': 'Janssen Pharmaceuticals NV, Beerse, Belgium.'}, {'ForeName': 'Joris J', 'Initials': 'JJ', 'LastName': 'Vandenbossche', 'Affiliation': 'Janssen Pharmaceuticals NV, Beerse, Belgium.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Talloen', 'Affiliation': 'Janssen Pharmaceuticals NV, Beerse, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Verbinnen', 'Affiliation': 'Janssen Pharmaceuticals NV, Beerse, Belgium.'}, {'ForeName': 'Iurie', 'Initials': 'I', 'LastName': 'Moscalu', 'Affiliation': 'Spitalul Clinic Republican, ARENSIA EM, Chișinău, Moldova.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Streinu-Cercel', 'Affiliation': 'National Institute for Infectious Diseases ""Prof. Dr Matei Bals"", Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bourgeois', 'Affiliation': 'ZNA Jan Palfijn, CPU, Antwerp, Belgium.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Buti', 'Affiliation': ""Hospital Universitario Vall d'Hebrón and CIBERHED del Instituto Carlos III, Barcelona, Spain.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Crespo', 'Affiliation': 'Hospital Universitario Marqués de Valdecilla, IDIVAL Santander, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Manuel Pascasio', 'Affiliation': 'Hospital Universitario Virgen del Rocio, Seville, Spain.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Sarrazin', 'Affiliation': 'Medizinische Klinik II, St. Josefs-Hospital, Weisbaden, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Vanwolleghem', 'Affiliation': 'Erasmus MC, University Medical Center, Rotterdam, Netherlands; Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Umesh', 'Initials': 'U', 'LastName': 'Shukla', 'Affiliation': 'Janssen Pharmaceuticals R&D, Titusville, New Jersey. Electronic address: UShukla@its.jnj.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Fry', 'Affiliation': 'Janssen Biopharma Inc., South San Francisco, California.'}, {'ForeName': 'Jeysen Z', 'Initials': 'JZ', 'LastName': 'Yogaratnam', 'Affiliation': 'Janssen Biopharma Inc., South San Francisco, California.'}]",Gastroenterology,['10.1053/j.gastro.2020.04.036']
15,32344133,Unilateral or Bilateral Percutaneous Endoscopic Debridement and Lavage Treatment for Lumbar Spinal Tuberculosis.,"OBJECTIVE


To compare the clinical outcome between bilateral percutaneous endoscopic debridement and lavage (PEDL) and unilateral PEDL treatment for lumbar spine tuberculosis (LST).
METHODS


A total of 40 patients with LST who underwent either bilateral PEDL (group A) or unilateral PEDL (group B) were reviewed. Perioperative parameters were assessed by operative time, intraoperative fluoroscopy times, and days of postoperative continuous irrigation and vacuum drainage. Clinical outcomes were evaluated in the Oswestry Disability Index (ODI), visual analog scale (VAS), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP). All patients were followed-up for at least 18 months after treatment.
RESULTS


The average operative time and intraoperative fluoroscopy time were increased in group A compared with those in group B. There was no statistical significance between the 2 groups in postoperative continuous irrigation and vacuum drainage days. The ESR and CRP curves in the 2 groups showed a similar trend during 18-month follow-up. The VAS and ODI in the 2 groups significantly decreased 6 and 18 months postsurgery. There was no significant difference in the incidence of complication between the 2 groups.
CONCLUSIONS


Two procedures yielded comparable and satisfactory results. Unilateral PEDL showed shorter operative time and decreased intraoperative fluoroscopy times compared with bilateral PEDL. We suggest the use of unilateral PEDL rather than bilateral PEDL in the treatment of LST.",2020,The average operative time and the intraoperative fluoroscopy times were increased in group A than those in group,"['lumbar spinal tuberculosis', 'A total of 40 patients with LST who underwent either', 'lumbar spine tuberculosis (LST']","['unilateral PEDL', 'bilateral PEDL', 'bilateral percutaneous endoscopic debridement and lavage (PEDL) and unilateral PEDL treatment', 'Unilateral or bilateral percutaneous endoscopic debridement and lavage treatment']","['intraoperative fluoroscopy times', 'ESR and CRP curves', 'Oswestry Disability Index (ODI), visual analog scale (VAS), erythrocyte sedimentation rate (ESR) and C-reactive protein(CRP', 'VAS and ODI', 'average operative time and the intraoperative fluoroscopy times', 'incidence of complication', 'operative time, intraoperative fluoroscopy times, and days of postoperative continuous irrigation and vacuum drainage', 'shorter operative time']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0041330', 'cui_str': 'Tuberculosis of vertebral column'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",40.0,0.0250191,The average operative time and the intraoperative fluoroscopy times were increased in group A than those in group,"[{'ForeName': 'Dongying', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Departments of Orthopedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China; Department of Orthopedics, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Weimin', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Departments of Orthopedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing, China. Electronic address: docweiminfan@126.com.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Yuan', 'Affiliation': 'Department of Orthopedics, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}]",World neurosurgery,['10.1016/j.wneu.2020.04.132']
16,32344285,"Non-thyroidal illness syndrome, the hidden player in the septic shock induced myocardial contractile depression.","Septic shock causes high mortality in hospitalized patients, especially in those that develop myocardial dysfunction as an early complication. The myocardial dysfunction of septic shock is characterized by a decrease in ventricular relaxation (diastolic dysfunction) and reduced ventricular ejection fraction (systolic dysfunction). Most patients with septic shock have low serum thyroid hormone levels, a condition known as non-thyroidal illness syndrome. Thyroid hormones sustain myocardial contractility and energy metabolism. Septic shock non-thyroidal illness syndrome causes myocardial hypothyroidism, and hypothyroidism causes myocardial dysfunction that resembles the myocardial depression of septic shock. We hypothesize that the myocardial hypothyroidism that occurs during septic shock has a causal role in the pathogenesis of septic shock-induced myocardial dysfunction. Thyroid hormones regulate the calcium cycle, the phenotype of contractile proteins, adrenergic response, and fatty acid transport and oxidation in the cardiomyocytes. Therefore, the administration of levothyroxine and liothyronine to normalize thyroid hormones level within the myocardium will improve the myocardial function. The hypothesis will be tested in humans with septic shock by performing a prospective, randomized, placebo-controlled study to compare the effect of thyroid hormone administration with placebo on myocardial function. The proposed hypothesis challenges the idea that non-thyroidal illness syndrome is a beneficial response of the thyroid hormone axis to illness and that thyroid hormone replacement is detrimental. The administration of thyroid hormone in order to prevent and reverse myocardial hypothyroidism during septic shock is a new theoretical concept on thyroid hormone metabolism and action at the tissue level during non-thyroidal illness syndrome. If the hypothesis is correct, clinicians should consider cardiac hypothyroidism as a central player in myocardial dysfunction caused by sepsis. Thyroid hormone replacement should be incorporated into the armamentarium of septic shock treatment.",2020,The myocardial dysfunction of septic shock is characterized by a decrease in ventricular relaxation (diastolic dysfunction) and reduced ventricular ejection fraction (systolic dysfunction).,"['hospitalized patients', 'humans with septic shock']","['Thyroid hormone replacement', 'levothyroxine and liothyronine', 'thyroid hormone', 'placebo']","['low serum thyroid hormone levels', 'ventricular relaxation (diastolic dysfunction) and reduced ventricular ejection fraction (systolic dysfunction', 'myocardial function']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}]","[{'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0041014', 'cui_str': 'liothyronine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040135', 'cui_str': 'Thyroid hormone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0749225', 'cui_str': 'Systolic dysfunction'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",,0.205492,The myocardial dysfunction of septic shock is characterized by a decrease in ventricular relaxation (diastolic dysfunction) and reduced ventricular ejection fraction (systolic dysfunction).,"[{'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Lado-Abeal', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Internal Medicine, Truman Medical Centers and University of Missouri Kansas City, MO, USA. Electronic address: joaquin.lado@tmcmed.org.'}]",Medical hypotheses,['10.1016/j.mehy.2020.109775']
17,32348168,"Evaluation of pain, disruptive behaviour and anxiety in children aging 5-8 years old undergoing different modalities of local anaesthetic injection for dental treatment: a randomised clinical trial.","Objective:  To evaluate the influence of different local anaesthetic techniques in pain, disruptive behaviour and anxiety in children´s dental treatment. Material and methods:  This was a randomised and parallel clinical trial. The sample consisted of 105 children (5-8 years old) that were divided into three groups ( n  = 35) according to the anaesthetic technique: conventional anaesthesia (CA); vibrational anaesthesia (VBA); computer-controlled local anaesthesia delivery (CCLAD). The outcomes were self-perception of pain (Wong-Baker Faces Pain Rating Scale - WBF; Numerical Rating Scale - NRS); disruptive behaviour (Face, Legg, Activity, Cry, Consolability Scale - FLACC); anxiety (Corah's Dental Anxiety Scale; modified Venham Picture test - VPTm) and physiological parameters (blood pressure - systolic - SBP and diastolic - DBP; heart rate - HR; oxygen saturation - SpO2; respiratory rate - RR). Data were statistically analysed with Kruskall-Wallis test and ANOVA for repeated measures with Tukey post hoc test ( α  = 0.05). Results:  All the patients exhibited the same level of dental anxiety at baseline (Corah's Dental Anxiety Scale). There was no difference in self-perception pain, irrespective the evaluation tool used (WBF -  p  = .864; VAS -  p  = .761). No differences were detected in disruptive behaviour (FLACC -  p  = .318); anxiety (VPTm -  p  = .274); blood pressure (SBP -  p  = .239; DBP -  p  = .512); heart rate ( p  = .728); oxygen saturation ( p  = .348) and respiratory rate ( p  = .238) between anaesthetic techniques. Conclusion:  Different anaesthetic dental local techniques do not affect the levels of pain, disruptive behaviour, anxiety and physiological parameters in children aged 5-8 years old.",2020,"There was no difference in self-perception pain, irrespective the evaluation tool used (WBF -  p  = .864; VAS -  p  = .761).","['children aging 5-8 years old undergoing different modalities of', 'pain, disruptive behaviour and anxiety in children´s dental treatment', 'children aged 5-8 years old', '105 children (5-8\u2009years old']","['anaesthetic technique: conventional anaesthesia (CA); vibrational anaesthesia (VBA); computer-controlled local anaesthesia delivery (CCLAD', 'local anaesthetic injection']","['disruptive behaviour', 'pain, disruptive behaviour and anxiety', 'blood pressure', 'levels of pain, disruptive behaviour, anxiety and physiological parameters', 'oxygen saturation', ""self-perception of pain (Wong-Baker Faces Pain Rating Scale - WBF; Numerical Rating Scale - NRS); disruptive behaviour (Face, Legg, Activity, Cry, Consolability Scale - FLACC); anxiety (Corah's Dental Anxiety Scale; modified Venham Picture test - VPTm) and physiological parameters (blood pressure - systolic - SBP and diastolic - DBP; heart rate - HR; oxygen saturation - SpO2; respiratory rate - RR"", 'heart rate', 'self-perception pain', 'respiratory rate', ""dental anxiety at baseline (Corah's Dental Anxiety Scale""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011331', 'cui_str': 'Dental care'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0238749', 'cui_str': 'Baker, general'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1306620', 'cui_str': 'Blood pressure systolic'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",105.0,0.0409434,"There was no difference in self-perception pain, irrespective the evaluation tool used (WBF -  p  = .864; VAS -  p  = .761).","[{'ForeName': 'Priscila de Camargo', 'Initials': 'PC', 'LastName': 'Smolarek', 'Affiliation': 'Departament of Dentistry, State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Leonardo Siqueira', 'Initials': 'LS', 'LastName': 'da Silva', 'Affiliation': 'Departament of Dentistry, State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Paula Regina Dias', 'Initials': 'PRD', 'LastName': 'Martins', 'Affiliation': 'Departament of Dentistry, State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Karen da Cruz', 'Initials': 'KDC', 'LastName': 'Hartman', 'Affiliation': 'Departament of Dentistry, State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Marcelo Carlos', 'Initials': 'MC', 'LastName': 'Bortoluzzi', 'Affiliation': 'Departament of Dentistry, State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}, {'ForeName': 'Ana Cláudia Rodrigues', 'Initials': 'ACR', 'LastName': 'Chibinski', 'Affiliation': 'Departament of Dentistry, State University of Ponta Grossa, Ponta Grossa, Paraná, Brazil.'}]",Acta odontologica Scandinavica,['10.1080/00016357.2020.1757752']
18,32282587,Accelerated Approval of 17α-Hydroxyprogesterone Caproate: A Cautionary Tale.,"Before 2011, 17α-hydroxyprogesterone caproate (17P) was used to prevent recurrent preterm birth in women with singleton pregnancies and was compounded at a low cost (∼$15 per injection). In 2011, the U.S. Food and Drug Administration (FDA) approved a commercial version of 17P (trade name ""Makena"") through their Accelerated Approval Program, and the price of 17P subsequently increased by nearly 100-fold. This approval was largely based on a methodologically limited, placebo-controlled trial, which found that although 17P significantly reduced preterm births, the placebo group had significantly more participants with a history of preterm birth, potentially confounding the results. The FDA required a confirmatory trial for continued approval that demonstrated clinical benefit. Eight years after accelerated approval, the confirmatory trial, PROLONG (Progestin's Role in Optimizing Neonatal Gestation), found no evidence of an effect of Makena for reducing recurrent preterm birth or perinatal mortality. Trial completion triggered an automatic review of Makena by an advisory committee, which voted 9-7 to recommend revoking approval of Makena for preterm birth. Although the FDA created the Accelerated Approval Program to introduce therapies for serious conditions that lacked treatment options, Makena is an example of the limitations of this program. We encourage the FDA to re-evaluate their program and consider improvements, such as shorter timeframes to complete confirmatory trials, potentially revoking approval if the studies are not completed within a predefined timeframe, and to hold manufacturers responsible, in part, for the costs of therapy if they cannot prove a clinical benefit.",2020,"Trial completion triggered an automatic review of Makena by an advisory committee, which voted 9-7 to recommend revoking approval of Makena for preterm birth.",['women with singleton pregnancies'],"['17α-hydroxyprogesterone caproate (17P', '17α-Hydroxyprogesterone Caproate', 'placebo']","['recurrent preterm birth or perinatal mortality', 'recurrent preterm birth']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0044971', 'cui_str': 'Hydroxyprogesterone caproate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}]",,0.196624,"Trial completion triggered an automatic review of Makena by an advisory committee, which voted 9-7 to recommend revoking approval of Makena for preterm birth.","[{'ForeName': 'Bethany J', 'Initials': 'BJ', 'LastName': 'Godlewski', 'Affiliation': 'Center for Evidence-based Policy at Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Lily I', 'Initials': 'LI', 'LastName': 'Sobolik', 'Affiliation': ''}, {'ForeName': 'Valerie J', 'Initials': 'VJ', 'LastName': 'King', 'Affiliation': ''}, {'ForeName': 'Curtis S', 'Initials': 'CS', 'LastName': 'Harrod', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003787']
19,32352250,Loteprednol etabonate gel 0.5% vs prednisolone acetate suspension 1% for the treatment of inflammation after cataract surgery in children.,"PURPOSE


To compare loteprednol etabonate (LE) gel 0.5% with prednisolone acetate suspension (PA) 1% for the treatment of inflammation after cataract surgery in children.
SETTING


Eleven sites in the United States.
DESIGN


Randomized, double-masked, parallel-group, noninferiority study.
METHODS


Eligible patients were aged 11 years or younger and candidates for routine, uncomplicated cataract surgery. Patients were randomized to a 4-week postsurgical regimen with LE gel 0.5% or PA 1%, twice on the day of surgery, 4 times daily for 2 weeks, twice daily for 1 week, and once daily for 1 week. Assessments included anterior chamber (AC) cells/flare, anterior chamber inflammation (ACI), synechiae, precipitates on the intraocular lens/cornea, visual acuity, and intraocular pressure.
RESULTS


The intent-to-treat population comprised 105 patients (LE gel, n = 53; PA 1%, n = 52) including 52 patients aged 3 years or younger. Patients achieved a similar mean ACI grade on postoperative day 14 (primary efficacy endpoint) whether treated with LE gel 0.5% or PA 1% (difference = 0.006, 2-sided 95% CI, -0.281 to 0.292). Similar ACI outcomes additionally were observed in patients aged 3 years or younger. LE gel 0.5% and PA 1% also appeared equally effective in resolving inflammation at all visits (days 7, 14, and 28 postsurgery), based on categorical distributions of ACI, AC cells, and AC flare scores/grades (P ≥ .06). Synechiae and corneal/IOL precipitates occurred infrequently with no significant differences between groups. No safety or tolerability concerns were identified, including no treatment-related IOP increases.
CONCLUSIONS


LE gel 0.5% was safe and effective in treating pediatric postcataract surgical inflammation, with similar outcomes as PA 1%.",2020,"LE gel and PA 1% also appeared equally effective in resolving inflammation at all visits (days 7, 14, 28 post-surgery), based on categorical distributions of ACI, AC cells, and AC flare scores/grades (P≥0.06).","['Eleven sites in the United States', '52 patients aged ≤3 years', 'Eligible patients were ≤11 years of age and candidates for routine, uncomplicated cataract surgery', 'patients ≤3 years of age', 'inflammation after cataract surgery in children']","['Loteprednol etabonate gel', 'loteprednol etabonate (LE) gel 0.5% with prednisolone acetate (PA) suspension', 'prednisolone acetate suspension', 'LE gel 0.5% or PA']","['safety or tolerability concerns', 'categorical distributions of ACI, AC cells, and AC flare scores/grades', 'Synechiae and corneal/implant precipitates', 'anterior chamber (AC) cells/flare, AC inflammation (ACI), synechiae, precipitates on the implant/cornea, visual acuity, and intraocular pressure (IOP']","[{'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0126177', 'cui_str': 'loteprednol etabonate'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0071839', 'cui_str': 'Prednisolone acetate'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0423282', 'cui_str': 'Anterior chamber cells'}, {'cui': 'C0423281', 'cui_str': 'Anterior chamber flare'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0154933', 'cui_str': 'Adhesions of iris'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C1096278', 'cui_str': 'Anterior chamber inflammation'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",52.0,0.0977674,"LE gel and PA 1% also appeared equally effective in resolving inflammation at all visits (days 7, 14, 28 post-surgery), based on categorical distributions of ACI, AC cells, and AC flare scores/grades (P≥0.06).","[{'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Vittitow', 'Affiliation': 'From Clinical Affairs, Bausch + Lomb (Vittitow), Bridgewater, New Jersey, and Clinical Affairs, Bausch + Lomb (Williams), Irvine, California, USA.'}, {'ForeName': 'Jon I', 'Initials': 'JI', 'LastName': 'Williams', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000218']
20,32350909,Clinical benefit of ixazomib plus lenalidomide-dexamethasone in myeloma patients with non-canonical NF-κB pathway activation.,"OBJECTIVES


Evaluating potential relationships between progression-free survival (PFS) and tumor gene expression patterns and mutational status was an exploratory objective of the phase 3 TOURMALINE-MM1 study (NCT01564537) of ixazomib-lenalidomide-dexamethasone (IRd) vs placebo-Rd in 722 patients with relapsed/refractory multiple myeloma (MM).
METHODS


We utilized gene expression and mutation data from screening bone marrow aspirates to identify tumors with non-canonical nuclear factor-κB (NF-κB) signaling pathway activation.
RESULTS


DNA/RNA sequencing data were available for 339 (47.0%)/399 (55.2%) patients; 49/339 (14.5%) patients had non-canonical NF-κB pathway gene mutations (tumor-necrosis-factor receptor-associated factor 2, 3 [TRAF2, TRAF3], baculoviral-inhibitor-of-apoptosis repeat-containing 2/3 [BIRC2/3]), and PFS was significantly longer with IRd vs placebo-Rd in these patients (hazard ratio [HR] 0.23). In patients with lower TRAF3 expression (median not reached vs 11 months, HR 0.47) and higher NF-κB-inducing kinase (NIK) expression (median not reached vs 14 months, HR 0.45), both associated with non-canonical NF-κB pathway activation, PFS was significantly longer with IRd vs placebo-Rd. TRAF3 expression was decreased in patients harboring t(4;14) and 1q21 amplification, suggesting increased non-canonical NF-κB pathway activation.
CONCLUSIONS


Adding ixazomib to Rd provides clinical benefit in MM tumors with increased non-canonical NF-κB pathway activity. This is a potential mechanism for activity in 1q21 amplified high-risk tumors.",2020,"TRAF3 expression was decreased in patients harboring t(4;14) and 1q21 amplification, suggesting increased non-canonical NF-κB pathway activation.
","['myeloma patients with non-canonical NF-κB pathway activation', 'screening bone marrow aspirates to identify tumors with non-canonical nuclear factor-κB (NF-κB) signaling pathway activation', '722 patients with relapsed/refractory multiple myeloma (MM']","['ixazomib-lenalidomide-dexamethasone (IRd) vs placebo-Rd', 'ixazomib plus lenalidomide-dexamethasone']","['TRAF3 expression', 'TRAF2, TRAF3], baculoviral-inhibitor-of-apoptosis repeat-containing 2/3 [BIRC2/3]), and PFS', 'NF-κB-inducing kinase (NIK) expression']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0857285', 'cui_str': 'Bone marrow aspirate'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0037080', 'cui_str': 'Signal Pathways'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}]","[{'cui': 'C3273711', 'cui_str': 'ixazomib'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0295022', 'cui_str': 'CD40 Receptor-Associated Factor 1'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0258441', 'cui_str': 'TRAF2'}, {'cui': 'C0079005', 'cui_str': 'Baculoviridae'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}]",722.0,0.0386312,"TRAF3 expression was decreased in patients harboring t(4;14) and 1q21 amplification, suggesting increased non-canonical NF-κB pathway activation.
","[{'ForeName': 'Ajeeta B', 'Initials': 'AB', 'LastName': 'Dash', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Berg', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Jianchang', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Avet-Loiseau', 'Affiliation': 'Hematology, IUC-Oncopole, Toulouse, France.'}, {'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'Southern Alberta Cancer Research Institute, Calgary, AB, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital Hôtel Dieu, University of Nantes, Nantes, France.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Hematologic Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Di Bacco', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}]",European journal of haematology,['10.1111/ejh.13435']
21,32289684,"A new, open-source 3D-printed transcranial magnetic stimulation (TMS) coil tracker holder for double blind, sham-controlled neuronavigation studies.",,2020,,[],['transcranial magnetic stimulation (TMS) coil tracker holder'],[],[],"[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C1551377', 'cui_str': 'Holder'}]",[],,0.16262,,"[{'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Caulfield', 'Affiliation': 'Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA. Electronic address: caulfiel@musc.edu.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Lopez', 'Affiliation': 'Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'Roberts', 'Affiliation': 'Department of Radiology & Radiological Science, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'McTeague', 'Affiliation': 'Brain Stimulation Laboratory, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.02.003']
22,32348286,A Digital Smoking Cessation Program for Heavy Drinkers: Pilot Randomized Controlled Trial.,"BACKGROUND


Heavy drinking (HD) is far more common among smokers compared with nonsmokers and interferes with successful smoking cessation. Alcohol-focused smoking cessation interventions delivered by counselors have shown promise, but digital versions of these interventions-which could have far greater population reach-have not yet been tested.
OBJECTIVE


This pilot randomized controlled trial aimed to examine the feasibility, acceptability, and effect sizes of an automated digital smoking cessation program that specifically addresses HD using an interactive web-based intervention with an optional text messaging component.
METHODS


Participants (83/119, 69.7% female; 98/119, 82.4% white; mean age 38.0 years) were daily smokers recruited on the web from a free automated digital smoking cessation program (BecomeAnEX.org, EX) who met the criteria for HD: women drinking 8+ drinks/week or 4+ drinks on any day and men drinking 15+ drinks/week or 5+ drinks on any day. Participants were randomized to receive EX with standard content (EX-S) or an EX with additional content specific to HD (EX-HD). Outcomes were assessed by web-based surveys at 1 and 6 months.
RESULTS


Participants reported high satisfaction with the website and the optional text messaging component. Total engagement with both EX-S and EX-HD was modest, with participants visiting the website a median of 2 times, and 52.9% of the participants enrolled to receive text messages. Participants in both the conditions showed substantial, significant reductions in drinking across 6 months of follow-up, with no condition effects observed. Although smoking outcomes tended to favor EX-HD, the condition effects were small and nonsignificant. A significantly smaller proportion of participants in EX-HD reported having a lapse back to smoking when drinking alcohol (7/58, 16%) compared with those in EX-S (18/61, 41%; χ 2 1 =6.2; P=.01).
CONCLUSIONS


This is the first trial to examine a digital smoking cessation program tailored to HD smokers. The results provide some initial evidence that delivering such a program is feasible and may reduce the risk of alcohol-involved smoking lapses. However, increasing engagement in this and other web-based interventions is a crucial challenge to address in future work.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03068611; https://clinicaltrials.gov/ct2/show/NCT03068611.",2020,"Participants in both the conditions showed substantial, significant reductions in drinking across 6 months of follow-up, with no condition effects observed.","['Participants (83/119, 69.7% female; 98/119, 82.4% white; mean age 38.0 years) were daily smokers recruited on the web from a free automated digital smoking cessation program (BecomeAnEX.org, EX) who met the criteria for HD: women drinking 8+ drinks/week or 4+ drinks on any day and men drinking 15+ drinks/week or 5+ drinks on any day', 'Heavy Drinkers', 'HD smokers']","['EX-S and EX-HD', 'Alcohol-focused smoking cessation interventions', 'automated digital smoking cessation program', 'Digital Smoking Cessation', 'EX with standard content (EX-S) or an EX with additional content specific to HD (EX-HD']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3266136', 'cui_str': 'Smokes tobacco daily'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",[],,0.0498056,"Participants in both the conditions showed substantial, significant reductions in drinking across 6 months of follow-up, with no condition effects observed.","[{'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Department of Behavioral and Social Sciences, Center for Alcohol and Addiction Studies, Brown University School of Public Health, Providence, RI, United States.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Cohn', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Costantino', 'Affiliation': 'Brown University School of Public Health, Providence, RI, United States.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Toll', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Nichea S', 'Initials': 'NS', 'LastName': 'Spillane', 'Affiliation': 'Department of Psychology, University of Rhode Island, South Kingston, RI, United States.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Graham', 'Affiliation': 'Innovations Center, Truth Initiative, Washington, DC, United States.'}]",JMIR formative research,['10.2196/formative.7570']
23,32348281,A Mind-Body Physical Activity Program for Chronic Pain With or Without a Digital Monitoring Device: Proof-of-Concept Feasibility Randomized Controlled Trial.,"BACKGROUND


Chronic pain is associated with poor physical and emotional functioning. Nonpharmacological interventions can help, but improvements are small and not sustained. Previous clinical trials do not follow recommendations to comprehensively target objectively measured and performance-based physical function in addition to self-reported physical function.
OBJECTIVE


This study aimed to establish feasibility benchmarks and explore improvements in physical (self-reported, performance based, and objectively measured) and emotional function, pain outcomes, and coping through a pilot randomized controlled trial of a mind-body physical activity program (GetActive) with and without a digital monitoring device (GetActive-Fitbit), which were iteratively refined through mixed methods.
METHODS


Patients with chronic pain were randomized to the GetActive (n=41) or GetActive-Fitbit (n=41) programs, which combine relaxation, cognitive behavioral, and physical restoration skills and were delivered in person. They completed in-person assessments before and after the intervention. Performance-based function was assessed with the 6-min walk test, and step count was measured with an ActiGraph.
RESULTS


Feasibility benchmarks (eg, recruitment, acceptability, credibility, therapist adherence, adherence to practice at home, ActiGraph wear, and client satisfaction) were good to excellent and similar in both programs. Within each program, we observed improvement in the 6-min walk test (mean increase=+41 m, SD 41.15; P<.001; effect size of 0.99 SD units for the GetActive group and mean increase=+50 m, SD 58.63; P<.001; effect size of 0.85 SD units for the GetActive-Fitbit group) and self-reported physical function (P=.001; effect size of 0.62 SD units for the GetActive group and P=.02; effect size of 0.38 SD units for the GetActive-Fitbit group). The mean step count increased only among sedentary patients (mean increase=+874 steps for the GetActive group and +867 steps for the GetActive-Fitbit group). Emotional function, pain intensity, pain coping, and mindfulness also improved in both groups. Participants rated themselves as much improved at the end of the program, and those in the GetActive-Fitbit group noted that Fitbit greatly helped with increasing their activity.
CONCLUSIONS


These preliminary findings support a fully powered efficacy trial of the two programs against an education control group. We present a model for successfully using the Initiative on the Methods, Measurement, and Pain Assessment in Clinical Trials criteria for a comprehensive assessment of physical function and following evidence-based models to maximize feasibility before formal efficacy testing.
TRIAL REGISTRATION


ClinicalTrial.gov NCT03412916; https://clinicaltrials.gov/ct2/show/NCT03412916.",2020,"Within each program, we observed improvement on the 6-minute walk test (+41 meters, P<.001, ES=.99 for GetActive; +50 meters, P<.001, ES=.85 for GetActive-Fitbit) and self-reported physical function (P=.001, ES=.62 for GetActive; P=.024, ES=.38 for GetActive-Fitbit).",['Patients with chronic pain were randomized to GetActive (N=41) or'],"['mind-body physical activity program (GetActive) with and without a digital monitoring device (GetActive-Fitbit', 'Mind-body physical activity program']","['6-minute walk test and step-count', 'physical function', '6-minute walk test', 'Emotional function, pain intensity, pain coping and mindfulness', 'physical (self-report, performance based and objective) and emotional function, pain outcomes and coping', 'Mean step count', 'acceptability, credibility, therapist adherence, adherence to home-practice, ActiGraph wear, and client satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}]",,0.059947,"Within each program, we observed improvement on the 6-minute walk test (+41 meters, P<.001, ES=.99 for GetActive; +50 meters, P<.001, ES=.85 for GetActive-Fitbit) and self-reported physical function (P=.001, ES=.62 for GetActive; P=.024, ES=.38 for GetActive-Fitbit).","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Greenberg', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Popok', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Lin', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Kulich', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'James', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Macklin', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, United States.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': 'Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Massachusetts General Hospital, Boston, MA, United States.'}]",JMIR formative research,['10.2196/18703']
24,32293959,Re: Radical Prostatectomy or Observation for Clinically Localized Prostate Cancer: Extended Follow-Up of the Prostate Cancer Intervention Versus Observation Trial (PIVOT).,,2020,,['Clinically Localized Prostate Cancer'],['Re: Radical Prostatectomy or Observation'],[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",[],,0.0173406,,"[{'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Taneja', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001056.01']
25,32353418,Fluid Response Evaluation in Sepsis Hypotension and Shock: A Randomized Clinical Trial.,"BACKGROUND


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


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


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


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


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


NCT02837731.",2020,"Fewer patients required renal replacement therapy (5.1% vs 17.5%, p=0.04) or mechanical ventilation (17.7% vs 34.1%, p=0.04) in the Intervention arm compared to Usual Care.","['Sepsis Hypotension and Shock', 'septic shock patients', 'patients with septic shock', '13 hospitals in the United States and United Kingdom', 'Patients presented to Emergency Rooms with sepsis associated hypotension and anticipated Intensive Care Unit (ICU) admission']","['Usual Care', 'Fluid Response Evaluation']","['renal replacement therapy', 'fluid responsiveness', 'mechanical ventilation', 'safety signals', 'positive fluid balance at 72 hours or ICU discharge, whichever occurred first']","[{'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C2364300', 'cui_str': 'Positive fluid balance'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}]",,0.241826,"Fewer patients required renal replacement therapy (5.1% vs 17.5%, p=0.04) or mechanical ventilation (17.7% vs 34.1%, p=0.04) in the Intervention arm compared to Usual Care.","[{'ForeName': 'Ivor S', 'Initials': 'IS', 'LastName': 'Douglas', 'Affiliation': 'Pulmonary Science and Critical Care Medicine, Denver Health Medical Center and University of Colorado, Anschutz Medical Campus, Denver, CO. Electronic address: ivor.douglas@dhha.org.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Alapat', 'Affiliation': 'Pulmonary, Critical Care and Sleep Medicine, Ben Taub Hospital, Houston, TX.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Corl', 'Affiliation': 'Pulmonary, Critical Care and Sleep Medicine, Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Exline', 'Affiliation': 'Pulmonary, Critical Care and Sleep Medicine, Ohio State University Hospital, Columbus, OH.'}, {'ForeName': 'Lui G', 'Initials': 'LG', 'LastName': 'Forni', 'Affiliation': 'Intensive Care Medicine and Nephrology, University of Surrey & Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Andre L', 'Initials': 'AL', 'LastName': 'Holder', 'Affiliation': 'Pulmonary, Allergy, Critical Care and Sleep Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kaufman', 'Affiliation': 'NYU School of Medicine, New York, NY; Pulmonary and Critical Care Medicine, Bridgeport Hospital, Bridgeport, CT.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Pulmonary and Critical Care Medicine, Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Mitchell M', 'Initials': 'MM', 'LastName': 'Levy', 'Affiliation': 'Pulmonary, Critical Care and Sleep Medicine, Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Martin', 'Affiliation': 'Pulmonary, Allergy, Critical Care and Sleep Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Sahatjian', 'Affiliation': 'Cheetah Medical, Wilmington, DE.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Seeley', 'Affiliation': 'Pulmonary, Critical Care Medicine and Allergy, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Wesley H', 'Initials': 'WH', 'LastName': 'Self', 'Affiliation': 'Department of Emergency Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Jeremy A', 'Initials': 'JA', 'LastName': 'Weingarten', 'Affiliation': 'Pulmonary, Critical Care and Sleep Medicine, New York-Presbyterian Brooklyn Methodist Hospital, Brooklyn, NY.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'Pulmonary and Critical Care Medicine, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Hansell', 'Affiliation': 'Cheetah Medical, Wilmington, DE; Department of Anesthesiology, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, MA.'}]",Chest,['10.1016/j.chest.2020.04.025']
26,32353419,"Impact of transcranial direct current stimulation on sustained attention in breast cancer survivors: Evidence for feasibility, tolerability, and initial efficacy.","BACKGROUND


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


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


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


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


Results suggest that tDCS is feasible, tolerable, and may be an effective intervention to improve sustained attention difficulties in survivors with cancer-related cognitive dysfunction.",2020,"Analyses of efficacy showed that during active stimulation, participants had significantly lower standard errors of reaction times overall, indicating better sustained attention ability, as compared to sham stimulation (p<0.05).","['survivors with cancer-related cognitive dysfunction', 'breast cancer survivors', '16 breast cancer survivors']","['Transcranial direct current stimulation (tDCS', 'tDCS', 'active tDCS', 'transcranial direct current stimulation']","['feasibility, tolerability, acceptability, and efficacy', 'standard errors of reaction times']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",16.0,0.118383,"Analyses of efficacy showed that during active stimulation, participants had significantly lower standard errors of reaction times overall, indicating better sustained attention ability, as compared to sham stimulation (p<0.05).","[{'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Gaynor', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA. Electronic address: gaynora@mskcc.org.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Pergolizzi', 'Affiliation': 'Universitat Internacional de Catalunya, School of Medicine and Health Sciences, Barcelona, Spain.'}, {'ForeName': 'Yesne', 'Initials': 'Y', 'LastName': 'Alici', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ryan', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'Katrazyna', 'Initials': 'K', 'LastName': 'McNeal', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Ahles', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Root', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Department of Psychiatry and Behavioral Sciences, New York, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.04.013']
27,32242978,Incentive spirometry to prevent acute chest syndrome in adults with sickle cell disease; a randomized controlled trial.,,2020,,['adults with sickle cell disease'],['Incentive spirometry'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]","[{'cui': 'C0454512', 'cui_str': 'Incentive spirometry'}]",[],,0.151465,,"[{'ForeName': 'Charlotte F J', 'Initials': 'CFJ', 'LastName': 'van Tuijn', 'Affiliation': 'Department of Hematology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Aafke E', 'Initials': 'AE', 'LastName': 'Gaartman', 'Affiliation': 'Department of Hematology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Nur', 'Affiliation': 'Department of Hematology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Anita W', 'Initials': 'AW', 'LastName': 'Rijneveld', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Biemond', 'Affiliation': 'Department of Hematology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}]",American journal of hematology,['10.1002/ajh.25805']
28,32349835,Improving social function with real-world social-cognitive remediation in schizophrenia: Results from the RemedRugby quasi-experimental trial.,"BACKGROUND


Functional capacity (FC) has been identified as a key outcome to improve real-world functioning in schizophrenia. FC is influenced by cognitive impairments, negative symptoms, self-stigma and reduced physical activity (PA). Psychosocial interventions targeting FC are still under-developed.
METHODS


we conducted a quasi-experimental study evaluating the effects of an exercise-enriched integrated social cognitive remediation (SCR) intervention (RemedRugby [RR]) compared with an active control group practicing Touch Rugby (TR). To our knowledge, this is the first trial to date evaluating the effectiveness of such a program provided in a real-life environment.
RESULTS


Eighty-seven people with schizophrenia were included and allocated to either the RR group (n = 57) or the TR group (n = 30) according to the routine clinical practice of the recruiting center. Outcomes were evaluated at baseline and post-treatment in both groups and after 6 months of follow-up in the RR group using standardized scales for symptom severity, social functioning, self-stigma, and a large cognitive battery. After treatment we observed moderate to large improvements in social function (Personal and Social Performance Scale [PSP], p < 0.001, d = 1.255), symptom severity (Positive and Negative Syndrome Scale [PANSS] negative, p < 0.001, d = 0.827; PANSS GP, p < 0.001, d = 0.991; PANSS positive, p = 0.009, d = 0.594), verbal abstraction (p = 0.008, d = 0.554), aggression bias (p = 0.008, d = 0.627), and self-stigma (stereotype endorsement, p = 0.019, d = 0.495; discrimination experiences, p = 0.047; d = 0.389) that were specific to the RR group and were not observed in participants playing only TR. Effects were persistent over time and even larger between post-treatment and follow-up.
CONCLUSIONS


Exercise-enriched integrated SCR appears promising to improve real-life functioning in schizophrenia. Future research should investigate the potential effects of this intervention on neuroplasticity and physical fitness.",2020,,['schizophrenia'],[],[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]",[],[],,0.0119092,,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Dubreucq', 'Affiliation': 'Centre de Neurosciences Cognitive, UMR 5229, CNRS and Université Lyon 1, Lyon, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Gabayet', 'Affiliation': 'Centre Référent de Réhabilitation Psychosociale et de Remédiation cognitive (C3R), Centre Hospitalier Alpes Isère, Grenoble, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Ycart', 'Affiliation': 'Laboratoire Jean Kuntzmann, CNRS UMR 5224, Université Grenoble-Alpes, Grenoble, France.'}, {'ForeName': 'Megane', 'Initials': 'M', 'LastName': 'Faraldo', 'Affiliation': 'Centre Référent de Réhabilitation Psychosociale et de Remédiation cognitive (C3R), Centre Hospitalier Alpes Isère, Grenoble, France.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Melis', 'Affiliation': 'Centre Référent de Réhabilitation Psychosociale et de Remédiation cognitive (C3R), Centre Hospitalier Alpes Isère, Grenoble, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lucas', 'Affiliation': 'Centre Référent de Réhabilitation Psychosociale et de Remédiation cognitive (C3R), Centre Hospitalier Alpes Isère, Grenoble, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Arnaud', 'Affiliation': 'Centre Hospitalier Sainte Marie de Clermont Ferrand, 33 rue Gabriel Péri, CS 9912, Clermont-Ferrand Cedex 1 63037, France.'}, {'ForeName': 'Mickael', 'Initials': 'M', 'LastName': 'Bacconnier', 'Affiliation': ""Centre Médical La Teppe, 25 Avenue de la Bouterne, CS 9721, Tain-l'Hermitage Cedex 26602, France.""}, {'ForeName': 'Motassem', 'Initials': 'M', 'LastName': 'Bakri', 'Affiliation': 'Centre de Réhabilitation Psychosociale et de Remédiation Cognitive (C2R), CH Drôme Vivarais, Montéléger, France.'}, {'ForeName': 'Gentiane', 'Initials': 'G', 'LastName': 'Cambier', 'Affiliation': 'Centre Hospitalier de la Savoie, 89 avenue de Bassens, Bassens73000, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Carmona', 'Affiliation': 'REHALise, CHU de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chereau', 'Affiliation': 'Fondation FondaMental, Créteil, France.'}, {'ForeName': 'Titaua', 'Initials': 'T', 'LastName': 'Challe', 'Affiliation': 'Centre Départemental de Réhabilitation Psychosociale des Glières, 219 Chemin des Bois des Fornets, La Roche sur Foron 74800, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Morel', 'Affiliation': 'Centre de Réhabilitation Psychosociale et de Remédiation Cognitive (C2R), CH Drôme Vivarais, Montéléger, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Pires', 'Affiliation': 'Fondation FondaMental, Créteil, France.'}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Roussel', 'Affiliation': 'Centre Départemental de Réhabilitation Psychosociale des Glières, 219 Chemin des Bois des Fornets, La Roche sur Foron 74800, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lamy', 'Affiliation': 'REHALise, CHU de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Legrand', 'Affiliation': 'Centre Hospitalier Sainte Marie de Clermont Ferrand, 33 rue Gabriel Péri, CS 9912, Clermont-Ferrand Cedex 1 63037, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Pages', 'Affiliation': 'Centre Hospitalier de la Savoie, 89 avenue de Bassens, Bassens73000, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Pommier', 'Affiliation': 'REHALise, CHU de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Rey', 'Affiliation': 'Fondation FondaMental, Créteil, France.'}, {'ForeName': 'Yohan', 'Initials': 'Y', 'LastName': 'Souchet', 'Affiliation': 'Fondation FondaMental, Créteil, France.'}, {'ForeName': 'Pierre-Michel', 'Initials': 'PM', 'LastName': 'Llorca', 'Affiliation': 'Fondation FondaMental, Créteil, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Massoubre', 'Affiliation': 'REHALise, CHU de Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European psychiatry : the journal of the Association of European Psychiatrists,['10.1192/j.eurpsy.2020.42']
29,32355123,Besifovir Dipivoxil Maleate 144-Week Treatment of Chronic Hepatitis B: An Open-Label Extensional Study of a Phase 3 Trial.,"INTRODUCTION


Chronic hepatitis B (CHB) remains a major worldwide public health concern. Besifovir dipivoxil maleate (BSV) is a new promising treatment for CHB. However, long-term efficacy and safety have not yet been evaluated. Therefore, the goal of the study is to determine the antiviral efficacy and safety of BSV treatment over a 144-week duration (BSV-BSV) in comparison with those of a sequential treatment with tenofovir disoproxil fumarate (TDF) followed by a 96-week duration BSV administration (TDF-BSV).
METHODS


After 48 weeks of a double-blind comparison between BSV and TDF treatments, patients continued the open-label BSV study. We evaluated antiviral efficacy and drug safety up to 144 weeks for BSV-BSV and TDF-BSV groups. The primary endpoint was a virological response (hepatitis B virus DNA < 69 IU/mL).
RESULTS


Among the 197 patients enrolled, 170 and 158 patients entered the second-year and third-year open-label phase extensional study, respectively, whereas 153 patients completed the 144-week follow-up. The virological response rate over the 144-week period was 87.7% and 92.1% in BSV-BSV and TDF-BSV groups, respectively (P = 0.36). The rates of ALT normalization and HBeAg seroconversion were similar between the groups. No drug-resistant mutations to BSV were noted. Bone mineral density and renal function were well preserved in the BSV-BSV group and were significantly improved after switching therapy in TDF-BSV patients.
DISCUSSION


This extensional study of a phase 3 trial (NCT01937806) suggests that BSV treatment is efficacious and safe for long-term use in treatment-naïve and TDF-experienced patients with CHB.",2020,"Bone mineral density and renal function were well preserved in the BSV-BSV group and were significantly improved after switching therapy in TDF-BSV patients.
","['Chronic Hepatitis B', '197 patients enrolled, 170 and 158 patients entered the second-year and third-year open-label phase extensional study, respectively, whereas 153 patients completed the 144-week follow-up', 'TDF-BSV patients']","['Besifovir dipivoxil maleate (BSV', 'tenofovir disoproxil fumarate (TDF', 'BSV', 'Besifovir Dipivoxil Maleate 144-Week', 'BSV and TDF']","['rates of ALT normalization and HBeAg seroconversion', 'virological response (hepatitis B virus DNA', 'antiviral efficacy and drug safety', 'Bone mineral density and renal function', 'antiviral efficacy and safety', 'virological response rate']","[{'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C4080032', 'cui_str': 'besifovir'}, {'cui': 'C0024572', 'cui_str': 'Maleates'}]","[{'cui': 'C4080032', 'cui_str': 'besifovir'}, {'cui': 'C0024572', 'cui_str': 'Maleates'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0369332', 'cui_str': 'Hepatitis B virus DNA'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",197.0,0.0320824,"Bone mineral density and renal function were well preserved in the BSV-BSV group and were significantly improved after switching therapy in TDF-BSV patients.
","[{'ForeName': 'Hyung Joon', 'Initials': 'HJ', 'LastName': 'Yim', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Won', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul Metropolitan Government Boramae Medical Center, Seoul, Korea.'}, {'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Mo', 'Initials': 'JM', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, Catholic University Medical College St. Vincent, Suwon, Korea.'}, {'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Soonchunhyang University, Seoul, Korea.'}, {'ForeName': 'Yong Oh', 'Initials': 'YO', 'LastName': 'Kweon', 'Affiliation': 'Department of Internal Medicine, Kyungpook National University College of Medicine, Daegu, Korea.'}, {'ForeName': 'Yong Kyun', 'Initials': 'YK', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Liver Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Gun Young', 'Initials': 'GY', 'LastName': 'Hong', 'Affiliation': 'Department of Internal Medicine, Kwangju Christian Hospital, Gwangju, Korea.'}, {'ForeName': 'Dong Joon', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Young Kul', 'Initials': 'YK', 'LastName': 'Jung', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Soon Ho', 'Initials': 'SH', 'LastName': 'Um', 'Affiliation': 'Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Joo Hyun', 'Initials': 'JH', 'LastName': 'Sohn', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Woo', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Sung Jae', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Paik Hospital, Inje University, Busan, Korea.'}, {'ForeName': 'Byung Seok', 'Initials': 'BS', 'LastName': 'Lee', 'Affiliation': 'Department of Gastroenterology and Hepatology, Chungnam National University School of Medicine, Daejeon, Korea.'}, {'ForeName': 'Ju Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Gacheon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Hong Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Seung Kew', 'Initials': 'SK', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Moon Young', 'Initials': 'MY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.'}, {'ForeName': 'Kwan Sik', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Young Suk', 'Initials': 'YS', 'LastName': 'Lim', 'Affiliation': 'Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Wan Sik', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Chonnam University Medical School, Gwangju, Korea.'}, {'ForeName': 'Kwang-Hyub', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000605']
30,30707002,Metabolic Syndrome Interferes with Packaging of Proteins within Porcine Mesenchymal Stem Cell-Derived Extracellular Vesicles.,"Mesenchymal stem/stromal cells (MSCs) release extracellular vesicles (EVs), which shuttle proteins to recipient cells, promoting cellular repair. We hypothesized that cardiovascular risk factors may alter the pattern of proteins packed within MSC-derived EVs. To test this, we compared the protein cargo of EVs to their parent MSCs in pigs with metabolic syndrome (MetS) and Lean controls. Porcine MSCs were harvested from abdominal fat after 16 weeks of Lean- or MetS-diet (n = 5 each), and their EVs isolated. Following liquid chromatography mass spectrometry proteomic analysis, proteins were classified based on cellular component, molecular function, and protein class. Five candidate proteins were validated by Western blot. Clustering analysis was performed to identify primary functional categories of proteins enriched in or excluded from EVs. Proteomics analysis identified 6,690 and 6,790 distinct proteins in Lean- and MetS-EVs, respectively. Differential expression analysis revealed that 146 proteins were upregulated and 273 downregulated in Lean-EVs versus Lean-MSCs, whereas 787 proteins were upregulated and 185 downregulated in MetS-EVs versus MetS-MSCs. Proteins enriched in both Lean- and MetS-EVs participate in vesicle-mediated transport and cell-to-cell communication. Proteins enriched exclusively in Lean-EVs modulate pathways related to the MSC reparative capacity, including cell proliferation, differentiation, and activation, as well as transforming growth factor-β signaling. Contrarily, proteins enriched only in MetS-EVs are linked to proinflammatory pathways, including acute inflammatory response, leukocyte transendothelial migration, and cytokine production. Coculture with MetS-EVs increased renal tubular cell inflammation. MetS alters the protein cargo of porcine MSC-derived EVs, selectively packaging specific proinflammatory signatures that may impair their ability to repair damaged tissues. Stem Cells Translational Medicine 2019;8:430-440.",2019,"Proteins enriched exclusively in Lean-EVs modulate pathways related to the MSC reparative capacity, including cell proliferation, differentiation, and activation, as well as transforming growth factor-β signaling.",['pigs with metabolic syndrome (MetS) and Lean controls'],['Mesenchymal stem/stromal cells (MSCs'],['renal tubular cell inflammation'],"[{'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0162597', 'cui_str': 'Stromal Cells'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.0250725,"Proteins enriched exclusively in Lean-EVs modulate pathways related to the MSC reparative capacity, including cell proliferation, differentiation, and activation, as well as transforming growth factor-β signaling.","[{'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Eirin', 'Affiliation': 'Divisions of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Xiang-Yang', 'Initials': 'XY', 'LastName': 'Zhu', 'Affiliation': 'Divisions of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Woollard', 'Affiliation': 'Divisions of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Divisions of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Surendra', 'Initials': 'S', 'LastName': 'Dasari', 'Affiliation': 'Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Lerman', 'Affiliation': 'Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Lilach O', 'Initials': 'LO', 'LastName': 'Lerman', 'Affiliation': 'Divisions of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota, USA.'}]",Stem cells translational medicine,['10.1002/sctm.18-0171']
31,32358413,Romosozumab in Skeletally Mature Adults with a Fresh Unilateral Tibial Diaphyseal Fracture: A Randomized Phase-2 Study.,"BACKGROUND


Romosozumab is an antibody that binds and inhibits sclerostin, thereby increasing bone formation and decreasing bone resorption. A double-blinded, randomized, phase-2, dose-finding trial was performed to evaluate the effect of romosozumab on the radiographic and clinical outcomes of surgical fixation of tibial diaphyseal fractures.
METHODS


Patients (18 to 82 years old) were randomized 3:1:1:1:1:1:1:1:1:1 to a placebo or 1 of 9 romosozumab treatment groups. Patients received subcutaneous injections of romosozumab or the placebo postoperatively on day 1 and weeks 2, 6, and 12. The primary outcome was the time to radiographic evidence of healing (""radiographic healing"") analyzed after the week-24 assessments had been completed for all patients.
RESULTS


A total of 402 patients were randomized: 299 to the romosozumab group and 103 to the placebo group. The median time to radiographic healing (the primary outcome) ranged from 14.4 to 18.6 weeks in the romosozumab groups and was 16.4 weeks (95% confidence interval [CI]: 14.6 to 18.0 weeks) in the placebo group, which was not a significant difference. There was also no significant difference in the median time to clinical healing, no relationship between romosozumab dose/frequency and unplanned revision surgery, and no apparent treatment benefit in terms of physical function. The safety and tolerability profile of romosozumab was comparable with that of the placebo.
CONCLUSIONS


Romosozumab did not accelerate tibial fracture-healing in this patient population. Additional studies of patients at higher risk for delayed healing are needed to explore the potential of romosozumab to accelerate tibial fracture-healing.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"There was also no significant difference in the median time to clinical healing, no relationship between romosozumab dose/frequency and unplanned revision surgery, and no apparent treatment benefit in terms of physical function.","['Patients (18 to 82 years old', '402 patients were randomized: 299 to the', 'Skeletally Mature Adults with a Fresh Unilateral Tibial Diaphyseal Fracture']","['Romosozumab', 'romosozumab', 'subcutaneous injections of romosozumab or the placebo', 'placebo']","['time to radiographic evidence of healing (""radiographic healing', 'tibial fracture-healing', 'median time to clinical healing', 'safety and tolerability profile of romosozumab', 'median time to radiographic healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C3661283', 'cui_str': 'romosozumab'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3661283', 'cui_str': 'romosozumab'}]",402.0,0.352627,"There was also no significant difference in the median time to clinical healing, no relationship between romosozumab dose/frequency and unplanned revision surgery, and no apparent treatment benefit in terms of physical function.","[{'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Emil H', 'Initials': 'EH', 'LastName': 'Schemitsch', 'Affiliation': 'Department of Surgery, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Theofilos', 'Initials': 'T', 'LastName': 'Karachalios', 'Affiliation': 'Orthopaedic Department UGHL, School of Health Sciences, University of Thessalia, Larissa, Greece.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Sancheti', 'Affiliation': 'Sancheti Institute of Orthopaedics and Rehabilitation, Pune, India.'}, {'ForeName': 'Rudolf W', 'Initials': 'RW', 'LastName': 'Poolman', 'Affiliation': 'Joint Research, OLVG, Amsterdam, the Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Caminis', 'Affiliation': 'Sanofi Genzyme, Bridgewater, New Jersey.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Daizadeh', 'Affiliation': 'Amgen, Inc., Thousand Oaks, California.'}, {'ForeName': 'Ricardo E', 'Initials': 'RE', 'LastName': 'Dent-Acosta', 'Affiliation': 'Amgen, Inc., Thousand Oaks, California.'}, {'ForeName': 'Ogo', 'Initials': 'O', 'LastName': 'Egbuna', 'Affiliation': 'Amgen, Inc., Thousand Oaks, California.'}, {'ForeName': 'Arkadi', 'Initials': 'A', 'LastName': 'Chines', 'Affiliation': 'Amgen, Inc., Thousand Oaks, California.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Miclau', 'Affiliation': 'Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, California.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01008']
32,32358417,Excisional goniotomy vs trabecular microbypass stent implantation: a prospective randomized clinical trial in eyes with mild to moderate open-angle glaucoma.,"PURPOSE


To compare reduction in intraocular pressure (IOP) and IOP-lowering medication in eyes undergoing excisional goniotomy with Kahook Dual Blade (KDB) vs iStent microbypass implantation, both combined with phacoemulsification, in eyes with mild to moderate open-angle glaucoma (OAG).
SETTING


Nine practices in the United States.
DESIGN


Prospective, randomized, active-controlled, parallel-group clinical trial.
METHODS


Eyes were randomized to KDB-Phaco or iStent-Phaco group. Demographics, corrected distance visual acuity, IOP, IOP-lowering medications, and adverse events were collected at baseline and at day 1, week 1, and months 1, 3, 6, and 12 postoperatively. The primary outcome measure was the proportion of eyes at 12 months with IOP reduction of 20% or greater or IOP medication reduction of 1 or more compared with baseline.
RESULTS


For this study, 164 eyes of 164 patients were analyzed (82 in each group). Mean IOP was reduced at 12 months compared with baseline from 18.5 (standard of error 0.4) to 15.4 (0.4) mm Hg in the KDB-Phaco group and from 18.5 (0.3) to 16.1 (0.4) mm Hg in the iStent-Phaco group (P = .24). Mean IOP-lowering medications were reduced from 1.3 (0.1) to 0.3 (0.1) in the KDB-Phaco group and from 1.4 (0.1) to 0.4 (0.1) in the iStent-Phaco group (P = .17). Among study completers, the primary outcome was attained in 74 (93.7%) of 79 patients of KDB-Phaco eyes and 65 (83.3%) of 78 patients of iStent-Phaco eyes (P = .04). Both procedures had similar safety profiles.
CONCLUSIONS


Both procedures lowered both IOP and the need for IOP-lowering medications effectively and safely in eyes with mild to moderate OAG and cataract. Significantly, more KDB-Phaco eyes than iStent-Phaco eyes met the primary outcome of 20% or greater IOP reduction or 1 or more medication reduction at 12 months.",2020,Both procedures lowered both IOP and the need for IOP-lowering medications effectively and safely in eyes with mild-moderate OAG and cataract.,"['eyes with mild to moderate open-angle glaucoma', '164 eyes/164 patient were analyzed (82 in each group', 'Eyes', 'eyes with mild-moderate open-angle glaucoma (OAG', 'eyes undergoing excisional goniotomy with', 'Nine practices in the United States']","['Excisional goniotomy vs trabecular microbypass stent implantation', 'KDB-Phaco or iStent-Phaco', 'Kahook Dual Blade v iStent microbypass implantation, both combined with phacoemulsification']","['Mean IOP-lowering medications', 'Mean IOP', 'intraocular pressure (IOP) and IOP-lowering medication', 'proportion of eyes at month 12 with IOP reduction >20% or IOP medication reduction', 'Demographics, corrected distance visual acuity, IOP, IOP-lowering medications, and adverse events']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0728940', 'cui_str': 'Excision'}, {'cui': 'C0018072', 'cui_str': 'Goniotomy'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0728940', 'cui_str': 'Excision'}, {'cui': 'C0018072', 'cui_str': 'Goniotomy'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.251138,Both procedures lowered both IOP and the need for IOP-lowering medications effectively and safely in eyes with mild-moderate OAG and cataract.,"[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Falkenberry', 'Affiliation': 'From the Gundersen Health System (Falkenberry), La Crosse, Wisconsin, The Eye Centers of Racine & Kenosha (Singh), Racine, Wisconsin, Northern New Jersey Eye Institute (Crane), South Orange, New Jersey, University of Louisville (Haider), Louisville, Kentucky, Ochsner Clinic Baton Rouge (Morgan, Grenier), Baton Rouge, Louisiana, Sacramento Eye Consultants (Brubaker), Sacramento, California, University of Pittsburgh (Balasubramani), Pittsburgh, Pennsylvania, Mayo Clinic (Dorairaj), Jacksonville, Florida, USA.'}, {'ForeName': 'Inder Paul', 'Initials': 'IP', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Crane', 'Affiliation': ''}, {'ForeName': 'Mohammed Ali', 'Initials': 'MA', 'LastName': 'Haider', 'Affiliation': ''}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Morgan', 'Affiliation': ''}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Grenier', 'Affiliation': ''}, {'ForeName': 'Jacob W', 'Initials': 'JW', 'LastName': 'Brubaker', 'Affiliation': ''}, {'ForeName': 'Goundappa K', 'Initials': 'GK', 'LastName': 'Balasubramani', 'Affiliation': ''}, {'ForeName': 'Syril', 'Initials': 'S', 'LastName': 'Dorairaj', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000229']
33,32293960,Re: Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression among Men with Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial.,,2020,,['Men with Early-Stage Prostate Cancer'],['Behavioral Intervention to Increase Vegetable Consumption'],['Cancer Progression'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0178874', 'cui_str': 'Tumor progression'}]",,0.0490649,,"[{'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Taneja', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001056']
34,32362226,Randomized Trial of a Mobile Personal Health Record for Behavioral Health Homes.,"OBJECTIVE


Behavioral health homes, which provide onsite primary medical care in mental health clinics, face challenges in integrating information across multiple health records. This study tested whether a mobile personal health record application improved quality of medical care for individuals treated in these settings.
METHODS


This randomized study enrolled 311 participants with a serious mental illness and one or more cardiometabolic risk factors across two behavioral health homes to receive a mobile personal health record application (N=156) or usual care (N=155). A secure mobile personal health record (mPHR) app provided participants in the intervention group with key information about diagnoses, medications, and laboratory test values and allowed them to track health goals. The primary study outcome was a chart-derived composite measure of quality of cardiometabolic and preventive services.
RESULTS


At 12-month follow-up, participants in the mPHR group maintained high quality of care (70% of indicated services at baseline and at 12-month follow-up), in contrast to a decline in quality for the usual-care group (71% at baseline and 67% at follow-up), resulting in a statistically significant but clinically modest differential impact between the groups. No differences between the study groups were found in secondary self-reported outcomes, including delivery of chronic illness care, patient activation, and quality of life related to mental or general medical health.
CONCLUSIONS


Use of a mPHR app was associated with a statistically significant but clinically modest differential benefit for quality of medical care among individuals with serious mental illness and comorbid cardiometabolic conditions.",2020,"No differences between the study groups were found in secondary self-reported outcomes, including delivery of chronic illness care, patient activation, and quality of life related to mental or general medical health.
","['individuals treated in these settings', 'Behavioral Health Homes', 'individuals with serious mental illness and comorbid cardiometabolic conditions', '311 participants with a serious mental illness and one or more cardiometabolic risk factors across two behavioral health homes to receive a mobile personal health record application (N=156) or usual care (N=155']","['mobile personal health record application', 'Mobile Personal Health']","['delivery of chronic illness care, patient activation, and quality of life related to mental or general medical health', 'quality of care', 'chart-derived composite measure of quality of cardiometabolic and preventive services', 'quality of medical care']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0018739', 'cui_str': 'Personal Health Records'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0018739', 'cui_str': 'Personal Health Records'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0199175', 'cui_str': 'Preventive service'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]",311.0,0.0822591,"No differences between the study groups were found in secondary self-reported outcomes, including delivery of chronic illness care, patient activation, and quality of life related to mental or general medical health.
","[{'ForeName': 'Benjamin G', 'Initials': 'BG', 'LastName': 'Druss', 'Affiliation': 'Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta.'}, {'ForeName': 'Jianheng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tapscott', 'Affiliation': 'Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta.'}, {'ForeName': 'Cathy A', 'Initials': 'CA', 'LastName': 'Lally', 'Affiliation': 'Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta.'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201900381']
35,32361414,Neural correlates of NOS1 ex1f-VNTR allelic variation in panic disorder and agoraphobia during fear conditioning and extinction in fMRI.,"Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior in animals. In humans, the short (S) allele of a functional promotor polymorphism of NOS1 (NOS1 ex1f-VNTR) has been shown to be associated with higher anxiety and altered fear conditioning in healthy subjects in the amygdala and hippocampus (AMY/HIPP). Here, we explore the role of NOS1 ex1f-VNTR as a pathophysiological correlate of panic disorder and agoraphobia (PD/AG). In a sub-sample of a multicenter cognitive behavioral therapy (CBT) randomized controlled trial in patients with PD/AG (n = 48: S/S-genotype n=15, S/L-genotype n=21, L/L-genotype n=12) and healthy control subjects, HS (n = 34: S/S-genotype n=7, S/L-genotype n=17, L/L-genotype=10), a differential fear conditioning and extinction fMRI-paradigm was used to investigate how NOS1 ex1f-VNTR genotypes are associated with differential neural activation in AMY/HIPP. Prior to CBT, L/L-allele carriers showed higher activation than S/S-allele carriers in AMY/HIPP. A genotype × diagnosis interaction revealed that the S-allele in HS was associated with a pronounced deactivation in AMY/HIPP, while patients showed contrary effects. The interaction of genotype × stimulus type (CS+, conditioned stimulus associated with an aversive stimulus vs. CS-, unassociated) showed effects on differential learning in AMY/HIPP. All effects were predominately found during extinction. Genotype associated effects in patients were not altered after CBT. Low statistical power due to small sample size in each subgroup is a major limitation. However, our findings provide first preliminary evidence for dysfunctional neural fear conditioning/extinction associated with NOS1 ex1f-VNTR genotype in the context of PD/AG, shedding new light on the complex interaction between genetic risk, current psychopathology and treatment-related effects.",2020,Genotype associated effects in patients were not altered after CBT.,"['n\xa0=\xa048', 'healthy subjects', 'animals', 'patients with PD/AG', 'panic disorder and agoraphobia during fear conditioning and extinction in fMRI']",['cognitive behavioral therapy (CBT'],['Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0669368', 'cui_str': 'Nitric Oxide Synthase, Type I'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0249077,Genotype associated effects in patients were not altered after CBT.,"[{'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Ridderbusch', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany. Electronic address: isabelle.ridderbusch@med.uni-marburg.de.'}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Herterich', 'Affiliation': 'Clinical Chemistry and Laboratory Medicine, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Pfleiderer', 'Affiliation': 'Medical Faculty, University of Münster and Department Clinical Radiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Arolt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität (LMU), München, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Straube', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102268']
36,32364137,Inadequate evaluation of potential side effects of sildenafil in preterm stopped Dutch trial.,Recently a drug trial in the Netherlands in which the efficacy of oral sildenafil was compared to placebo in women bearing children with fetal growth restriction was stopped early because of very harmful side effects to the babies. There were quite some unwanted and unscientific aspects related to this study and the manner in which the side effects were communicated to the patients and the community. These have not gained the attention they ought to have. We therefore made an analysis of the basic problems which aims to prevent that the trust in medical research will be weakened.,2020,These have not gained the attention they ought to have.,"['preterm stopped Dutch trial', 'women bearing children with fetal growth restriction']","['placebo', 'sildenafil']",[],"[{'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}]",[],,0.0922729,These have not gained the attention they ought to have.,"[{'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'Bijl', 'Affiliation': 'Physician-Epidemiologist, Utrecht, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Healy', 'Affiliation': 'Professor of Psychiatry, Hergest Unit, Bangor, Wales, UK.'}]",The International journal of risk & safety in medicine,['10.3233/JRS-202003']
37,32363614,Statistical properties of minimal sufficient balance and minimization as methods for controlling baseline covariate imbalance at the design stage of sequential clinical trials.,"When the number of baseline covariates whose imbalance needs to be controlled in a sequential randomized controlled trial is large, minimization is the most commonly used method for randomizing treatment assignments. The lack of allocation randomness associated with the minimization method has been the source of controversy, and the need to reduce even minor imbalances inherent in the minimization method has been challenged. The minimal sufficient balance (MSB) method is an alternative to the minimization method. It prevents serious imbalance from a large number of covariates while maintaining a high level of allocation randomness. In this study, the two treatment allocation methods are compared with regards to the effectiveness of balancing covariates across treatment arms and allocation randomness in equal allocation clinical trials. The MSB method proves to be equal or superior in both respects. In addition, type I error rate is preserved in analyses for both balancing methods, when using a binary endpoint.",2020,The MSB method proves to be equal or superior in both respects.,[],[],[],[],[],[],,0.0750872,The MSB method proves to be equal or superior in both respects.,"[{'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Lauzon', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Nietert', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Jody D', 'Initials': 'JD', 'LastName': 'Ciolino', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Neuroscience, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Wenle', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}]",Statistics in medicine,['10.1002/sim.8552']
38,32363656,Lower cognitive baseline scores predict cognitive training success after 6 months in healthy older adults: Results of an online RCT.,"BACKGROUND


Identifying predictors for general cognitive training (GCT) success in healthy older adults has many potential uses, including aiding intervention and improving individual dementia risk prediction, which are of high importance in health care. However, the factors that predict training improvements and the temporal course of predictors (eg, do the same prognostic factors predict training success after a short training period, such as 6 weeks, as well as after a longer training period, such as 6 months?) are largely unknown.
METHODS


Data (N = 4,184 healthy older individuals) from two arms (GCT vs. control) of a three-arm randomized controlled trial were reanalyzed to investigate predictors of GCT success in five cognitive tasks (grammatical reasoning, spatial working memory, digit vigilance, paired association learning, and verbal learning) at three time points (after 6 weeks, 3 months, and 6 months of training). Possible investigated predictors were sociodemographic variables, depressive symptoms, number of training sessions, cognitive baseline values, and all interaction terms (group*predictor).
RESULTS


Being female was predictive for improvement in grammatical reasoning at 6 weeks in the GCT group, and lower cognitive baseline scores were predictive for improvement in spatial working memory and verbal learning at 6 months.
CONCLUSION


Our data indicate that predictors seem to change over time; remarkably, lower baseline performance at study entry is only a significant predictor at 6 months training. Possible reasons for these results are discussed in relation to the compensation hypothesis. J Am Geriatr Soc 68:-, 2020.",2020,"RESULTS


Being female was predictive for improvement in grammatical reasoning at 6 weeks in the GCT group, and lower cognitive baseline scores were predictive for improvement in spatial working memory and verbal learning at 6 months.
","['Data (N\xa0=\xa04184 healthy older individuals', 'healthy older adults', 'Healthy Older Adults']","['general cognitive training (GCT', 'Online RCT']","['sociodemographic variables, depressive symptoms, number of training sessions, cognitive baseline values, and all interaction terms (group*predictor', 'spatial working memory and verbal learning', 'grammatical reasoning', 'cognitive tasks (grammatical reasoning, spatial working memory, digit vigilance, paired association learning, and verbal learning']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",4184.0,0.0336916,"RESULTS


Being female was predictive for improvement in grammatical reasoning at 6 weeks in the GCT group, and lower cognitive baseline scores were predictive for improvement in spatial working memory and verbal learning at 6 months.
","[{'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Roheger', 'Affiliation': 'Department of Medical Psychology, Neuropsychology and Gender Studies & Center for Neuropsychological Diagnostics and Intervention (CeNDI), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Kalbe', 'Affiliation': 'Department of Medical Psychology, Neuropsychology and Gender Studies & Center for Neuropsychological Diagnostics and Intervention (CeNDI), University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Corbett', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brooker', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, University of Exeter, Exeter, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Ballard', 'Affiliation': 'Institute of Health Research, University of Exeter Medical School, University of Exeter, Exeter, UK.'}]",International journal of geriatric psychiatry,['10.1002/gps.5322']
39,32359688,Back to the future-Are we ready for a randomized trial of surgical versus percutaneous revascularization in cardiogenic shock?,,2020,,[],['percutaneous revascularization'],[],[],"[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",[],,0.0411241,,"[{'ForeName': 'Jason N', 'Initials': 'JN', 'LastName': 'Katz', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University, Durham, NC. Electronic address: jason.katz@duke.edu.'}]",American heart journal,['10.1016/j.ahj.2020.03.006']
40,32371116,Efficacy of Real-Time Computer-Aided Detection of Colorectal Neoplasia in a Randomized Trial.,"BACKGROUND & AIMS


One-fourth of colorectal neoplasias are missed during screening colonoscopies; these can develop into colorectal cancer (CRC). Deep learning systems allow for real-time computer-aided detection (CADe) of polyps with high accuracy. We performed a multicenter, randomized trial to assess the safety and efficacy of a CADe system in detection of colorectal neoplasias during real-time colonoscopy.
METHODS


We analyzed data from 685 subjects (61.32 ± 10.2 years old; 337 men) undergoing screening colonoscopies for CRC, post-polypectomy surveillance, or workup due to positive results from a fecal immunochemical test or signs or symptoms of CRC, at 3 centers in Italy from September through November 2019. Patients were randomly assigned (1:1) to groups who underwent high-definition colonoscopies with the CADe system or without (controls). The CADe system included an artificial intelligence-based medical device (GI-Genius, Medtronic) trained to process colonoscopy images and superimpose them, in real time, on the endoscopy display a green box over suspected lesions. A minimum withdrawal time of 6 minutes was required. Lesions were collected and histopathology findings were used as the reference standard. The primary outcome was adenoma detection rate (ADR, the percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy, non-neoplastic resection rate, and withdrawal time.
RESULTS


The ADR was significantly higher in the CADe group (54.8%) than in the control group (40.4%) (relative risk [RR], 1.30; 95% confidence interval [CI], 1.14-1.45). Adenomas detected per colonoscopy were significantly higher in the CADe group (mean, 1.07 ±1.54) than in the control group (mean 0.71 ± 1.20) (incidence rate ratio, 1.46; 95% CI, 1.15-1.86). Adenomas 5 mm or smaller were detected in a significantly higher proportion of subjects in the CADe group (33.7%) than in the control group (26.5%; RR, 1.26; 95% CI, 1.01-1.52), as were adenomas of 6 to 9 mm (detected in 10.6% of subjects in the CADe group vs 5.8% in the control group; RR, 1.78; 95% CI, 1.09-2.86), regardless of morphology or location. There was no significant difference between groups in withdrawal time (417 ± 101 seconds for the CADe group vs 435 ± 149 for controls; P = .1) or proportion of subjects with resection of non-neoplastic lesions (26.0% in the CADe group vs 28.7% of controls; RR, 1.00; 95% CI, 0.90-1.12).
CONCLUSIONS


In a multicenter, randomized trial, we found that including CADe in real-time colonoscopy significantly increases ADR and adenomas detected per colonoscopy without increasing withdrawal time. ClinicalTrials.gov no: 04079478.",2020,"There was no significant difference between groups in withdrawal time (417±101 sec for the CADe group vs 435±149 for controls; P=.1) or proportion of subjects with resection of non-neoplastic lesions (26.0% in the CADe group vs 28.7% of controls; RR, 1.00; 95% CI, 0.90-1.12).
","['685 subjects (61.32±10.2 years old; 337 women) undergoing screening colonoscopies for CRC, post-polypectomy surveillance, or work up due to positive results from a fecal immunochemical test or signs or symptoms of CRC, at three centers in Italy from September through November 2019', 'polyps with high-accuracy']","['Real-Time Computer-Aided Detection', 'high-definition colonoscopies with the CADe system or without (controls', 'CADe system']","['adenoma detection rate (ADR, the percentage of patients with at least 1 histologically proven adenoma or carcinoma', 'ADR', 'resection of non-neoplastic lesions', 'withdrawal time', 'safety and efficacy', 'Adenomas detected per colonoscopy', 'adenomas detected per colonoscopy, non-neoplastic resection rate, and withdrawal time']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]",,0.129523,"There was no significant difference between groups in withdrawal time (417±101 sec for the CADe group vs 435±149 for controls; P=.1) or proportion of subjects with resection of non-neoplastic lesions (26.0% in the CADe group vs 28.7% of controls; RR, 1.00; 95% CI, 0.90-1.12).
","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Repici', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy. Electronic address: alessandro.repici@hunimed.eu.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Badalamenti', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Maselli', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Loredana', 'Initials': 'L', 'LastName': 'Correale', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Radaelli', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Rondonotti', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Ferrara', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Spadaccini', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Alkandari', 'Affiliation': 'Thanyan Alghanim Center for Gastroenterology and Hepatology, Alamiri Hospital, Kuwait, Kuwait.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Fugazza', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Anderloni', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Piera Alessia', 'Initials': 'PA', 'LastName': 'Galtieri', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Pellegatta', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Carrara', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Di Leo', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Craviotto', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lamonaca', 'Affiliation': 'Department of Gastroenterology, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Lorenzetti', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.'}, {'ForeName': 'Alida', 'Initials': 'A', 'LastName': 'Andrealli', 'Affiliation': 'Gastroenterology Department, Valduce Hospital, Como, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Antonelli', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida.'}, {'ForeName': 'Prateek', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': 'Kansas City Veterans Affairs Hospital, Kansas City, Missouri.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rosch', 'Affiliation': 'Department of Interdisciplinary Endoscopy, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Cesare', 'Initials': 'C', 'LastName': 'Hassan', 'Affiliation': 'Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.'}]",Gastroenterology,['10.1053/j.gastro.2020.04.062']
41,32374442,Comparing case-based and lecture-based learning strategies for orthodontic case diagnosis: A randomized controlled trial.,"BACKGROUND


Case-based learning (CBL), in contrast to traditional lecture-based learning (LBL), is an andragogical method carrying an earnest teaching approach that uses demonstration of clinical cases as an active learning tool.
OBJECTIVE


To compare the effectiveness of knowledge delivery and student satisfaction between CBL and LBL strategies to diagnose orthodontic cases.
METHODS


A single-blinded randomized controlled trial was performed. The sample of dental undergraduate students was randomly divided into 2 groups. Average GPA among the groups was compared to establish the baseline measure. Visual slides of 6 orthodontic diagnostic cases were presented to the students after implementing the teaching strategies, and a rubrics-based assessment method was adopted to assess the effectiveness in diagnosis. A questionnaire was distributed to compare the level of satisfaction between the groups exposed to CBL and LBL. A t-test was performed to assess the difference in effectiveness, while Cochran-Armitage trend analysis was performed to analyze the difference in the level of satisfaction between LBL and CBL experiences.
RESULTS


We detected no significant (P = 0.11) relation of gender with effective orthodontic diagnosis. The orthodontic diagnostic ability of students for the 6 cases was significantly different (P < 0.05) in the CBL and LBL groups. The satisfaction score obtained for the CBL group was higher than for the LBL group (P < 0.05).
CONCLUSION


The current study provides evidence that CBL is an effective and acceptable teaching strategy in comparison to traditional LBL among undergraduate dental students embarking on an orthodontic diagnostic course.",2020,"The satisfaction score obtained for the CBL group was higher than for the LBL group (P < 0.05).
","['6 orthodontic diagnostic cases', 'sample of dental undergraduate students', 'orthodontic case diagnosis']","['Case-based learning (CBL', 'LBL', 'CBL', 'traditional lecture-based learning (LBL', 'lecture-based learning strategies']","['level of satisfaction', 'satisfaction score', 'orthodontic diagnostic ability', 'Visual slides']","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}]",,0.0415369,"The satisfaction score obtained for the CBL group was higher than for the LBL group (P < 0.05).
","[{'ForeName': 'Anwar', 'Initials': 'A', 'LastName': 'Alhazmi', 'Affiliation': 'Division of Orthodontics, Department of Preventive Dental Sciences, College of Dentistry, Jazan University, Jazan, Saudi Arabia.'}, {'ForeName': 'Mir Faeq Ali', 'Initials': 'MFA', 'LastName': 'Quadri', 'Affiliation': 'Evidence Based Dentistry, Department of Preventive Dental Sciences, College of Dentistry, Jazan University, Jazan, Saudi Arabia.'}]",Journal of dental education,['10.1002/jdd.12171']
42,32304630,Correction to Lancet Infect Dis 2020; published online March 30. https://doi.org/10.1016/S1473-3099(20)30243-7.,,2020,,[],['https://doi.org/10.1016/S1473-3099(20)30243-7'],[],[],[],[],,0.0193234,,[],The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30309-1']
43,32369661,"Double-blind, randomized controlled trial of therapeutic plasma exchanges vs sham exchanges in moderate-to-severe relapses of multiple sclerosis.","INTRODUCTION


No randomized controlled clinical trial of therapeutic plasma exchanges (TPE) has yet been performed for moderate-to-severe relapses of multiple sclerosis (MS).
OBJECTIVE


To compare TPE to sham-TPE in patients with a recent steroid-resistant moderate-to-severe MS relapse.
METHODS


Patients presenting with an MS relapse of less than 2 months without improvement and 15 days after a course of steroids were randomized. Specific criteria were used for each relapse type to define moderate-to-severe disability. The primary endpoint was the proportion of patients with at least a moderate improvement based on objective and functional evaluation after 1 month.
RESULTS


Thirty-eight patients were randomized. The intention-to-treat analysis included 14 patients in the TPE group and 17 in the Sham-TPE group. The proportion of patients with at least moderate improvement at 1 month did not differ between the groups (P = .72), although 57.1% of the TPE group had full recovery compared with 17.6% of the sham group. Considering optic neuritis (ON), a significant difference in the proportion of different levels of improvement was observed in favor of the TPE group (P = .04). The combined Kurtzke's functional systems scores were significantly more improved in the TPE group than in the sham-TPE group at months 1 (P < .01), 3 (P < .05), and 6 (P < .05). No major side effects were observed.
CONCLUSIONS


A significant difference between TPE and Sham-TPE at the primary endpoint was only observed in patients with ON. Neurological function improved significantly more often in the TPE group than in the sham-TPE group.",2020,The combined Kurtzke's functional systems scores were significantly more improved in the TPE group than in the sham-TPE group at months 1,"['14 patients in the TPE group and 17 in the Sham-TPE group', 'Thirty-eight patients were randomized', 'moderate-to-severe relapses of multiple sclerosis', 'Patients presenting with an MS relapse of less than 2 months without improvement and 15\u2009days after a course of steroids were randomized', 'patients with a recent steroid-resistant moderate-to-severe MS relapse']","['TPE to sham-TPE', 'therapeutic plasma exchanges (TPE', 'TPE', 'TPE and Sham-TPE', 'sham-TPE']","['proportion of patients with at least a moderate improvement based on objective and functional evaluation', 'full recovery', 'Neurological function', ""combined Kurtzke's functional systems scores""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",38.0,0.0777967,The combined Kurtzke's functional systems scores were significantly more improved in the TPE group than in the sham-TPE group at months 1,"[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'CHU de Bordeaux, Service de Neurologie, Bordeaux, France.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Deloire', 'Affiliation': 'CHU de Bordeaux, Service de Neurologie, Bordeaux, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Germain', 'Affiliation': 'USMR, Pole de Sante Publique, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Ouallet', 'Affiliation': 'CHU de Bordeaux, Service de Neurologie, Bordeaux, France.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wittkop', 'Affiliation': 'USMR, Pole de Sante Publique, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Dulau', 'Affiliation': 'CHU de Bordeaux, Service de Neurologie, Bordeaux, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Perez', 'Affiliation': 'USMR, Pole de Sante Publique, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Thevenot', 'Affiliation': ""Etablissement Français du Sang, Site de l'Hôpital Pellegrin, Bordeaux, France.""}, {'ForeName': 'Jérome', 'Initials': 'J', 'LastName': 'De Sèze', 'Affiliation': 'Service de Neurologie, CHU de Strasbourg, Strasbourg, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Zéphir', 'Affiliation': 'Univ.Lille, Inserm U1172, CHU Lille, FHU Imminent, Lille, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vermersch', 'Affiliation': 'Univ.Lille, Inserm U1172, CHU Lille, FHU Imminent, Lille, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pittion', 'Affiliation': 'Service de Neurologie, CHU de Nancy, Nancy, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Debouverie', 'Affiliation': 'Service de Neurologie, CHU de Nancy, Nancy, France.'}, {'ForeName': 'David-Axel', 'Initials': 'DA', 'LastName': 'Laplaud', 'Affiliation': 'Service de Neurologie, CHU de Nantes, Nantes, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Clavelou', 'Affiliation': 'Service de Neurologie, CHU de Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Ruet', 'Affiliation': 'CHU de Bordeaux, Service de Neurologie, Bordeaux, France.'}]",Journal of clinical apheresis,['10.1002/jca.21788']
44,32360392,A randomized controlled trial of transcranial direct-current stimulation and cognitive training in children with fetal alcohol spectrum disorder.,"BACKGROUND


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


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


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


These results demonstrate that tDCS-augmented CT is well tolerated in children with FASD and potentially offers benefits over and above CT alone.",2020,The tDCS group showed nominally significant improvement in attention on a continuous performance test compared to sham (p=.043).,"['children with fetal alcohol spectrum disorder', 'children with Fetal Alcohol Spectrum Disorders (FASD', 'children with FASD', '44 children with FASD']","['CT with either active or sham tDCS', 'transcranial direct current stimulation (tDCS) augmented cognitive training (CT', 'transcranial direct-current stimulation and cognitive training', 'tDCS', 'tDCS-augmented CT', 'CT', 'TDCS-augmented CT']","['feasibility and efficacy', 'trail making task', 'attention scores and decrease in parent-reported attention deficits', 'attention on a continuous performance test']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015923', 'cui_str': 'Fetal alcohol syndrome'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",44.0,0.0938664,The tDCS group showed nominally significant improvement in attention on a continuous performance test compared to sham (p=.043).,"[{'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Boroda', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Krueger', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Bansal', 'Affiliation': 'University of Maryland, USA.'}, {'ForeName': 'Mariah J', 'Initials': 'MJ', 'LastName': 'Schumacher', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Abhrajeet V', 'Initials': 'AV', 'LastName': 'Roy', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Boys', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Kelvin O', 'Initials': 'KO', 'LastName': 'Lim', 'Affiliation': 'University of Minnesota, Twin Cities, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Wozniak', 'Affiliation': 'University of Minnesota, Twin Cities, USA. Electronic address: jwozniak@umn.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.04.015']
45,32360038,Outcomes After Left Main Coronary Artery Revascularization by Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting According to Smoking Status.,"Cigarette smoking is a well-known risk factor for coronary artery disease (CAD). However, the impact of smoking on outcomes after coronary revascularization, especially in patients with left main CAD (LMCAD) is less well understood. The EXCEL trial randomized 1,905 patients with LMCAD and visually assessed low or intermediate anatomical complexity (SYNTAX score ≤32) to PCI with everolimus-eluting stents or CABG. Patients were categorized according to smoking status (current, former, or never), and their outcomes at 5 years were compared by logistic regression with follow-up time included as a log-transformed offset variable. The primary endpoint was a composite of death, myocardial infarction, or stroke. Among 1893 patients with known smoking status at baseline, 416 (22%) were current smokers and 774 (41%) were former smokers. The crude rates of the primary endpoint were 19.5% for never smokers, 20.5% for former smokers (p = 0.61 vs never smokers), and 23.1% for smokers (p = 0.15 vs never smokers). Compared with never smokers, the adjusted risk of the primary endpoint was higher for current smokers (adjOR 1.82, 95% confidence interval [CI] 1.126 to 2.63; p = 0.001), but not for former smokers (adjOR 1.00, 95% CI 0.75 to 1.33, p = 0.10). The relative efficacy of PCI versus CABG for the 5-year primary endpoint was similar irrespective of smoking status (P interaction  = 0.22). In conclusion, current smokers in the EXCEL trial had a higher adjusted 5-year risk of the primary composite endpoint of death, myocardial infarction, or stroke than never smokers, whereas former smokers were not at increased risk. Active smoking was a risk factor after LMCAD revascularization irrespective of revascularization method.",2020,"Compared with never smokers, the adjusted risk of the primary endpoint was higher for current smokers (adjOR 1.82, 95% confidence interval [CI] 1.126 to 2.63; p = 0.001), but not for former smokers (adjOR 1.00, 95% CI 0.75 to 1.33, p = 0.10).","['patients with left main CAD (LMCAD', '1,905 patients with LMCAD and visually assessed low or intermediate anatomical complexity (SYNTAX score ≤32) to', '1893 patients with known smoking status at baseline, 416 (22%) were current smokers and 774 (41%) were former smokers']","['PCI versus CABG', 'Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting', 'PCI with everolimus-eluting stents or CABG']","['composite of death, myocardial infarction, or stroke', 'death, myocardial infarction, or stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",1905.0,0.0367596,"Compared with never smokers, the adjusted risk of the primary endpoint was higher for current smokers (adjOR 1.82, 95% confidence interval [CI] 1.126 to 2.63; p = 0.001), but not for former smokers (adjOR 1.00, 95% CI 0.75 to 1.33, p = 0.10).","[{'ForeName': 'Bahira', 'Initials': 'B', 'LastName': 'Shahim', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden; NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Hôpital privé Jacques Cartier, Ramsay Générale de Santé, Massy, France.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Gersh', 'Affiliation': 'Department of Cardiovascular Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Puskas', 'Affiliation': ""Mount Sinai Heart at Mount Sinai Saint Luke's, New York, New York.""}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, Georgia.'}, {'ForeName': 'Béla', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Ferenc', 'Initials': 'F', 'LastName': 'Horkay', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Crowley', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, NUIG, National University of Ireland, Galway, Ireland; Imperial College of Science, Technology and Medicine, London, United Kingdom.'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': 'Department of Surgery, UH Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: gstone@crf.org.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.04.029']
46,32370910,"Re: Prostate-specific Membrane Antigen PET-CT in Patients with High-risk Prostate Cancer Before Curative-intent Surgery or Radiotherapy (proPSMA): A Prospective, Randomised, Multi-centre Study.",,2020,,['Patients with High-risk Prostate Cancer'],"['Curative-intent Surgery or Radiotherapy (proPSMA', 'Re: Prostate-specific Membrane Antigen PET-CT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}]",[],,0.0420788,,"[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Hadaschik', 'Affiliation': 'Department of Urology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany. Electronic address: boris.hadaschik@uk-essen.de.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Herrmann', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}]",European urology,['10.1016/j.eururo.2020.04.051']
47,32378922,Mindfulness training for emotion dysregulation in multiple sclerosis: A pilot randomized controlled trial.,"OBJECTIVE


People with multiple sclerosis (PwMS) report greater emotion dysregulation, which is associated with increased symptoms of depression and anxiety, and reduced quality of life. Given the transdiagnostic significance of emotion dysregulation, the current study was designed to assess the feasibility and treatment effects of mindfulness meditation in reducing emotion dysregulation for PwMS.
METHOD


Sixty-one PwMS were randomized to 1 of 3 groups: 4-week mindfulness-based training (MBT), 4-week adaptive cognitive training (aCT), or a waitlist control group. Using self-report and behavioral measures, we examined the effects of MBT on emotion dysregulation, use of emotion regulation strategies, experience of negative and positive affect, and overall quality of life.
RESULTS


Mindfulness training was associated with reduced emotion dysregulation compared with the adaptive cognitive training and the waitlist control group (η p ² = .20). Relative to the waitlist group, the MBT group also demonstrated reductions on a composite score of preservative cognition, measuring rumination and worry (η p ² = .15). However, there was no differential use of emotion regulation strategies or between-groups differences in overall quality of life as a function of training.
CONCLUSIONS


Our pilot study provides preliminary support for MBT to reduce self-reported emotion dysregulation in PwMS. Given the widespread prevalence of mental health disturbances in this population, MBT can serve as a promising rehabilitation tool for PwMS (clinicaltrials.gov # NCT02717429). (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"RESULTS


Mindfulness training was associated with reduced emotion dysregulation compared with the adaptive cognitive training and the waitlist control group (η p ² = .20).","['Sixty-one PwMS', 'People with multiple sclerosis (PwMS', 'multiple sclerosis']","['4-week mindfulness-based training (MBT), 4-week adaptive cognitive training (aCT), or a waitlist control group', 'MBT', 'mindfulness meditation', 'Mindfulness training']","['emotion dysregulation, use of emotion regulation strategies, experience of negative and positive affect, and overall quality of life', 'composite score of preservative cognition, measuring rumination and worry', 'reduced emotion dysregulation', 'overall quality of life']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0233481', 'cui_str': 'Worried'}]",61.0,0.0221003,"RESULTS


Mindfulness training was associated with reduced emotion dysregulation compared with the adaptive cognitive training and the waitlist control group (η p ² = .20).","[{'ForeName': 'Brittney', 'Initials': 'B', 'LastName': 'Schirda', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Duraney', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'H Kyu', 'Initials': 'HK', 'LastName': 'Lee', 'Affiliation': 'Posit Science Corporation.'}, {'ForeName': 'Heena R', 'Initials': 'HR', 'LastName': 'Manglani', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Andridge', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Plate', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jaqueline A', 'Initials': 'JA', 'LastName': 'Nicholas', 'Affiliation': 'Division of Neuroimmunology and Multiple Sclerosis.'}, {'ForeName': 'Ruchika Shaurya', 'Initials': 'RS', 'LastName': 'Prakash', 'Affiliation': 'Department of Psychology.'}]",Rehabilitation psychology,['10.1037/rep0000324']
48,32379010,Feasibility of test administration and preliminary findings for cognitive control in the Burn 2 learn pilot randomised controlled trial.,"The feasibility requirements of administering field-based cognitive assessments are rarely reported. We examined the feasibility of administering a group-based cognitive test battery in a school setting with older adolescents. Several types of reliability were also assessed in the control group. Preliminary efficacy and the relationship between changes in fitness and changes in cognitive control were also explored following a 14-week HIIT intervention (3 sessions/week). Participants completed a cognitive test battery measuring inhibition (flanker), and working memory (n-back) at baseline and post-test. Health-related fitness assessments were also conducted. Test administration took approximately 30.8 ± 1.5 minutes to complete with up to six participants simultaneously. The test battery demonstrated acceptable reliability (ICC = 0.5-0.81), with significant changes observed for flanker incongruent accuracy, and 2-back non-target accuracy from baseline to post-test. Regarding efficacy, small-to-moderate effects were observed for accuracy outcomes, while several small associations were found between changes in fitness and changes in cognition. Findings from the current study suggest a cognitive test battery can be administered with older adolescents in a school setting. However, there remains a lack of adequate reporting of administration requirements for field-based cognitive assessments. Efficacy findings should be confirmed with a larger and more representative sample of older adolescents.",2020,"The test battery demonstrated acceptable reliability (ICC = 0.5-0.81), with significant changes observed for flanker incongruent accuracy, and 2-back non-target accuracy from baseline to post-test.","['older adolescents in a school setting', 'older adolescents', 'school setting with older adolescents']",[],"['acceptable reliability', 'cognitive test battery measuring inhibition (flanker), and working memory (n-back', 'flanker incongruent accuracy, and 2-back non-target accuracy', 'fitness and changes in cognition']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],"[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C1321310', 'cui_str': 'Incongruous'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",6.0,0.0337063,"The test battery demonstrated acceptable reliability (ICC = 0.5-0.81), with significant changes observed for flanker incongruent accuracy, and 2-back non-target accuracy from baseline to post-test.","[{'ForeName': 'Angus A', 'Initials': 'AA', 'LastName': 'Leahy', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle , Callaghan, Australia.'}, {'ForeName': 'Madieke F I', 'Initials': 'MFI', 'LastName': 'Michels', 'Affiliation': 'Chairgroup Health and Society, Wageningen University and Research , Wageningen, Netherlands.'}, {'ForeName': 'Narelle', 'Initials': 'N', 'LastName': 'Eather', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle , Callaghan, Australia.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Hillman', 'Affiliation': 'Department of Psychology, Northeastern University , Boston, MA, USA.'}, {'ForeName': 'Tatsuya T', 'Initials': 'TT', 'LastName': 'Shigeta', 'Affiliation': 'Department of Psychology, Northeastern University , Boston, MA, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle , Callaghan, Australia.'}, {'ForeName': 'Jordan J', 'Initials': 'JJ', 'LastName': 'Smith', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, School of Education, University of Newcastle , Callaghan, Australia.'}]",Journal of sports sciences,['10.1080/02640414.2020.1756673']
49,32311925,Evaluation of photobiomodulation in salivary production of patients with xerostomy induced by anti-hypertensive drugs: Study protocol clinical trial (SPIRIT compliant).,"INTRODUCTION


Hypertension (systemic arterial hypertension [SAH]) is a systemic condition that affects about 30% of the world population, according to data from the World Health Organization (WHO). Drugs used to control this disease have the potential to induce xerostomia, an oral condition in which the decrease of the salivary flow is observed and whose presence leads to the increase of the index of caries, periodontal disease, loss of the teeth, dysgeusia, difficulty of mastication, dysphagia, bad breath and oral burning and impairment of prothesis installed in the buccal cavity, including retention of removable and total dentures.
METHODS


This is a randomized, placebo-controlled, blind clinical protocol that aims to analyze the impact of phobiomodulation (PBM) on salivary glands of patients with antihypertensive drug induced xerostomia. Patients will be divided into 2 groups: G1: older adults with xerostomia induced by antihypertensive drugs and treatment with PBM (n = 30); G2: placebo PBM (n = 30). The irradiation will be made using a diode laser emitting at 808 nm with 100 mW and 40 seconds of exposure per site at the salivary glands. Twenty sites will be irradiated weekly for 4 weeks. Non-stimulated and stimulated salivary flow will be analyzed before and after the treatment.
RESULTS


This protocol will determine the effectiveness of photodynamic therapy regarding the reduction of xerostomia in older adults using antihypertensive drugs.
CONCLUSION


This protocol will determine the effectiveness of photodynamic therapy regarding the reduction of xerostomia in older adults using antihypertensive drugs.
TRIAL REGISTRATION


Clinicaltrials.gov - NCT03632096.",2020,Patients will be divided into 2 groups: G1: older adults with xerostomia induced by antihypertensive drugs and treatment with PBM (n = 30); G2: placebo PBM (n = 30).,"['patients with xerostomy induced by anti-hypertensive drugs', 'n\u200a=\u200a30', 'Patients will be divided into 2 groups: G1: older adults with xerostomia induced by antihypertensive drugs and treatment with PBM (n\u200a=\u200a30); G2', 'patients with antihypertensive drug induced xerostomia', 'older adults using antihypertensive drugs']","['placebo PBM', 'phobiomodulation (PBM', 'placebo', 'photobiomodulation', 'photodynamic therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]",[],,0.152994,Patients will be divided into 2 groups: G1: older adults with xerostomia induced by antihypertensive drugs and treatment with PBM (n = 30); G2: placebo PBM (n = 30).,"[{'ForeName': 'Maria Lucia Zarvos', 'Initials': 'MLZ', 'LastName': 'Varellis', 'Affiliation': 'Postgraduate Program in Biophotonics Applied to Health Sciences, University Nove de Julho (UNINOVE), Rua Vergueiro, Liberdade, São Paulo, Brazil.'}, {'ForeName': 'Marcela Leticia Leal', 'Initials': 'MLL', 'LastName': 'Gonçalves', 'Affiliation': ''}, {'ForeName': 'Vanessa Christina Santos', 'Initials': 'VCS', 'LastName': 'Pavesi', 'Affiliation': ''}, {'ForeName': 'Anna Carolina Ratto Tempestini', 'Initials': 'ACRT', 'LastName': 'Horliana', 'Affiliation': ''}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'de Fátima Teixeira da Silva', 'Affiliation': ''}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': ''}, {'ForeName': 'Valdomiro F', 'Initials': 'VF', 'LastName': 'Barbosa Filho', 'Affiliation': ''}, {'ForeName': 'Cícero Dayves Silva', 'Initials': 'CDS', 'LastName': 'Bezerra', 'Affiliation': ''}, {'ForeName': 'Felipe Gonçalves da', 'Initials': 'FGD', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': ''}, {'ForeName': 'Alessandro M', 'Initials': 'AM', 'LastName': 'Deana', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000019583']
50,32376732,"Oral nitrate supplementation to enhance pulmonary rehabilitation in COPD: ON-EPIC a multicentre, double-blind, placebo-controlled, randomised parallel group study.","RATIONALE


Dietary nitrate supplementation has been proposed as a strategy to improve exercise performance, both in healthy individuals and in people with COPD. We aimed to assess whether it could enhance the effect of pulmonary rehabilitation (PR) in COPD.
METHODS


This double-blind, placebo-controlled, parallel group, randomised controlled study performed at four UK centres, enrolled adults with Global Initiative for Chronic Obstructive Lung Disease grade II-IV COPD and Medical Research Council dyspnoea score 3-5 or functional limitation to undertake a twice weekly 8-week PR programme. They were randomly assigned (1:1) to either 140 mL of nitrate-rich beetroot juice (BRJ) (12.9 mmol nitrate), or placebo nitrate-deplete BRJ, consumed 3 hours prior to undertaking each PR session. Allocation used computer-generated block randomisation.
MEASUREMENTS


The primary outcome was change in incremental shuttle walk test (ISWT) distance. Secondary outcomes included quality of life, physical activity level, endothelial function via flow-mediated dilatation, fat-free mass index and blood pressure parameters.
RESULTS


165 participants were recruited, 78 randomised to nitrate-rich BRJ and 87 randomised to placebo. Exercise capacity increased more with active treatment (n=57) than placebo (n=65); median (IQR) change in ISWT distance +60 m (10, 85) vs +30 m (0, 70), estimated treatment effect 30 m (95% CI 10 to 40); p=0.027. Active treatment also impacted on systolic blood pressure: treatment group -5.0 mm Hg (-5.0, -3.0) versus control +6.0 mm Hg (-1.0, 15.5), estimated treatment effect -7 mm Hg (95% CI 7 to -20) (p<0.0005). No significant serious adverse events or side effects were reported.
CONCLUSIONS


Dietary nitrate supplementation appears to be a well-tolerated and effective strategy to augment the benefits of PR in COPD.
TRIAL REGISTRATION NUMBER


ISRCTN27860457.",2020,"Exercise capacity increased more with active treatment (n=57) than placebo (n=65); median (IQR) change in ISWT distance +60 m (10, 85) vs +30 m (0, 70), estimated treatment effect 30 m (95% CI 10 to 40); p=0.027.","['healthy individuals and in people with COPD', '165 participants were recruited, 78 randomised to', 'COPD', 'four UK centres, enrolled adults with Global Initiative for Chronic Obstructive Lung Disease grade II-IV COPD and Medical Research Council dyspnoea score 3-5 or functional limitation to undertake a twice weekly 8-week PR programme']","['placebo', 'nitrate-rich BRJ', 'Oral nitrate supplementation', '140\u2009mL of nitrate-rich beetroot juice (BRJ) (12.9\u2009mmol nitrate), or placebo nitrate-deplete BRJ', 'pulmonary rehabilitation (PR']","['serious adverse events or side effects', 'Exercise capacity', 'quality of life, physical activity level, endothelial function via flow-mediated dilatation, fat-free mass index and blood pressure parameters', 'systolic blood pressure', 'incremental shuttle walk test (ISWT) distance', 'median (IQR) change in ISWT distance', 'exercise performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",165.0,0.764259,"Exercise capacity increased more with active treatment (n=57) than placebo (n=65); median (IQR) change in ISWT distance +60 m (10, 85) vs +30 m (0, 70), estimated treatment effect 30 m (95% CI 10 to 40); p=0.027.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Pavitt', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Rebecca Jayne', 'Initials': 'RJ', 'LastName': 'Tanner', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Buttery', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Bhavin', 'Initials': 'B', 'LastName': 'Mehta', 'Affiliation': 'Respiratory Medicine, Royal Brompton and Harefield NHS Foundation Trust, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Jefford', 'Affiliation': 'Greenwich Adult Community Health Service, Oxleas NHS Foundation Trust, Dartford, Kent, UK.'}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Curtis', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Winston A S', 'Initials': 'WAS', 'LastName': 'Banya', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Husain', 'Affiliation': 'Respiratory Medicine, Maidstone and Tunbridge Wells NHS Trust, Maidstone, Kent, UK.'}, {'ForeName': 'Karnan', 'Initials': 'K', 'LastName': 'Satkunam', 'Affiliation': 'Greenwich Adult Community Health Service, Oxleas NHS Foundation Trust, Dartford, Kent, UK.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Shrikrishna', 'Affiliation': 'Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, Taunton, Somerset, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Man', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Polkey', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Hopkinson', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK n.hopkinson@ic.ac.uk.'}]",Thorax,['10.1136/thoraxjnl-2019-214278']
51,32371539,Concurrent Definitive Immunoradiotherapy for Patients with Stage III-IV Head and Neck Cancer and Cisplatin Contraindication.,"PURPOSE


Although cisplatin plus radiotherapy is a standard treatment of locally advanced head and neck squamous cell carcinoma (LA-HNSCC), cisplatin contraindication is common. Radiation elicits and promotes tumor-directed immune stimulation, which may potentiate anti-PD-1 therapy. We provide the first efficacy report of combined pembrolizumab and definitive radiotherapy in LA-HNSCC.
PATIENTS AND METHODS


This single-arm, multi-institution, phase II study (NCT02609503) enrolled 29 cisplatin-ineligible patients. Patients received radiotherapy concurrently with three cycles of pembrolizumab 200 mg every 3 weeks followed by three adjuvant cycles. The primary endpoint was a progression-free survival (PFS) of ≥16 months. Correlative studies included peripheral blood flow cytometry and Luminex cytokine profiling.
RESULTS


Reasons for cisplatin ineligibility included otopathy (69.0%), nephropathy (20.7%), and neuropathy (6.9%). With median follow-up of 21 months, estimated 24-month PFS and overall survival rates were 71% (95% confidence interval, 49%-84%) and 75% (51%-88%). The primary PFS endpoint has exceeded the hypothesis and its median has not been reached. Toxicities were typical of radiotherapy; however, high rates of grade 3/4 lymphopenia (58.6%) were observed. Flow cytometry revealed a relative decline in CD4 T cells and B cells, but not CD8 T cells. Upon treatment, frequencies of transitional B cells and tissue-like memory B cells increased, while resting memory B cells decreased. Patients with progression had greater percentages of baseline naïve B cells and fewer marginal zone B cells.
CONCLUSIONS


Pembrolizumab and radiotherapy is efficacious in LA-HNSCC and should be evaluated in a randomized trial. The observed changes in B-cell markers deserve further study both as potential biomarkers and as therapeutic targets.",2020,"Flow cytometry revealed a relative decline in CD4 T cells and B cells, but not CD8 T cells.","['patients with Stage III-IV Head and Neck Cancer and Cisplatin contraindication', '29 cisplatin ineligible patients', 'locally advanced head and neck squamous cell carcinoma (LA-HNSCC']","['radiotherapy', 'cisplatin plus radiotherapy', 'Concurrent definitive immunoradiotherapy', 'Pembrolizumab and radiotherapy', 'combined pembrolizumab and definitive radiotherapy', 'pembrolizumab']","['rates of grade 3/4 lymphopenia', 'nephropathy', 'OS rates', 'frequencies of transitional B cells and tissue-like memory B cells', 'peripheral blood flow cytometry and Luminex cytokine profiling', 'PFS of >16 months', 'baseline naïve B cells and fewer marginal zone B cells', 'CD4 T cells and B cells, but not CD8 T cells', 'Toxicities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0085101', 'cui_str': 'Radioimmunotherapy'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1512631', 'cui_str': 'Immature B-Lymphocytes'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0425710', 'cui_str': 'Peripheral blood flow'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",29.0,0.0669333,"Flow cytometry revealed a relative decline in CD4 T cells and B cells, but not CD8 T cells.","[{'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Weiss', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina. Jared_Weiss@med.unc.edu.'}, {'ForeName': 'Siddharth', 'Initials': 'S', 'LastName': 'Sheth', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Allision M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Department of Biostatistics, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Juneko E', 'Initials': 'JE', 'LastName': 'Grilley Olson', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Samip', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Trevor G', 'Initials': 'TG', 'LastName': 'Hackman', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Blumberg', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Galloway', 'Affiliation': 'Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Shetal', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Zanation', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Colette J', 'Initials': 'CJ', 'LastName': 'Shen', 'Affiliation': 'Department of Radiation Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'D Neil', 'Initials': 'DN', 'LastName': 'Hayes', 'Affiliation': 'Division of Hematology and Oncology, University of Tennessee West Institute for Cancer Research, Memphis, Tennessee.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hilliard', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Ranee', 'Initials': 'R', 'LastName': 'Mehra', 'Affiliation': 'Division of Hematology and Oncology, Marlene and Stewart Greenebaum Comprehensive Cancer Center at the University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'McKinnon', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Hsing-Hui', 'Initials': 'HH', 'LastName': 'Wang', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Mark Christian', 'Initials': 'MC', 'LastName': 'Weissler', 'Affiliation': 'Department of Otolaryngology/Head and Neck Surgery, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Bauman', 'Affiliation': 'Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Bhishamjit S', 'Initials': 'BS', 'LastName': 'Chera', 'Affiliation': 'Department of Radiation Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Benjamin G', 'Initials': 'BG', 'LastName': 'Vincent', 'Affiliation': 'Division of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, North Carolina.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0230']
52,32376872,"Correction: Ketamine metabolites, clinical response, and gamma power in a randomized, placebo-controlled, crossover trial for treatment-resistant major depression.",An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,[],['placebo'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.114074,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Cristan A', 'Initials': 'CA', 'LastName': 'Farmer', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Gilbert', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ruin', 'Initials': 'R', 'LastName': 'Moaddel', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Jomy', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Adeojo', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Lovett', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Peixiong', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Gould', 'Affiliation': 'Departments of Psychiatry, Pharmacology, and Anatomy and Neurobiology, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Park', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. zaratec@mail.nih.gov.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0699-7']
53,32383337,Incidence and characteristics of pregnancy-related death across ten low- and middle-income geographical regions: secondary analysis of a cluster randomised controlled trial.,"OBJECTIVE


The aim of this article is to describe the incidence and characteristics of pregnancy-related death in low- and middle-resource settings, in relation to the availability of key obstetric resources.
DESIGN


This is a secondary analysis of a stepped-wedge cluster randomised controlled trial.
SETTING


This trial was undertaken at ten sites across eight low- and middle-income countries in sub-Saharan Africa, India and Haiti.
POPULATION


Institutional-level consent was obtained and all women presenting for maternity care were eligible for inclusion.
METHODS


Pregnancy-related deaths were collected prospectively from routine data sources and active case searching.
MAIN OUTCOME MEASURES


Pregnancy-related death, place, timing and age of maternal death, and neonatal outcomes in women with this outcome.
RESULTS


Over 20 months, in 536 233 deliveries there were 998 maternal deaths (18.6/10 000, range 28/10 000-630/10 000). The leading causes of death were obstetric haemorrhage (36.0%, n = 359), hypertensive disorders of pregnancy (20.6%, n = 206), sepsis (14.1%, n = 141) and other (26.5%, n = 264). Approximately a quarter of deaths occurred prior to delivery (28.4%, n = 283), 35.7% (n = 356) occurred on the day of delivery and 35.9% (n = 359) occurred after delivery. Half of maternal deaths (50.6%; n = 505) occurred in women aged 20-29 years, 10.3% (n = 103) occurred in women aged under 20 years, 34.5% (n = 344) occurred in women aged 30-39 years and 4.6% (n = 46) occurred in women aged ≥40 years. There was no measured association between the availability of key obstetric resources and the rate of pregnancy-related death.
CONCLUSIONS


The large variation in the rate of pregnancy-related death, irrespective of resource availability, emphasises that inequality and inequity in health care persists.
TWEETABLE ABSTRACT


Inequality and inequity in pregnancy-related death persists globally, irrespective of resource availability.",2020,"Approximately a quarter of deaths occurred prior to delivery (28.4%, n=283), 35.7% on the day of delivery (n=356) and 35.9% after delivery (n=359).","['Pregnancy-related deaths were prospectively collected from routine data sources and active case finding', '10 sites across eight low and middle-income countries in sub-Saharan Africa, India and Haiti', 'Half of maternal deaths (50.6%; n=505) occurred in women aged 20-29, 10.3% under 20 years (n=103), 34.5% aged 30-39 (n=344) and 4.6% (n=46) aged ≥40', 'women presenting for maternity care were eligible for inclusion']",[],"['Incidence and characteristics of pregnancy-related death', '998 maternal deaths', 'availability of key obstetric resources and the rate of pregnancy-related death', 'Pregnancy-related death, place, timing and age of maternal death and neonatal outcomes', 'sepsis', 'hypertensive disorders of pregnancy']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0011001', 'cui_str': 'Data Sources'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0018510', 'cui_str': 'Haiti'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}]",,0.351709,"Approximately a quarter of deaths occurred prior to delivery (28.4%, n=283), 35.7% on the day of delivery (n=356) and 35.9% after delivery (n=359).","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Vousden', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Holmes', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Gidiri', 'Affiliation': 'Department of Obstetrics and Gynaecology, College of Health Sciences, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Goudar', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sandall', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chinkoyo', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ndola Teaching Hospital, Ndola, Zambia.'}, {'ForeName': 'L Y', 'Initials': 'LY', 'LastName': 'Kumsa', 'Affiliation': 'Maternity Worldwide, Brighton, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Maternity Worldwide, Brighton, UK.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Charantimath', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bellad', 'Affiliation': ""Women's and Children's Health Research Unit, KLE Academy of Higher Education and Research Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nakimuli', 'Affiliation': 'Department of Obstetrics and Gynaecology, School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vwalika', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Zambia School of Medicine, Lusaka, Zambia.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16309']
54,32375605,Randomized multicenter study on long-term complications of peripherally inserted central catheters positioned by electrocardiographic technique.,"BACKGROUND


The intracavitary electrocardiogram (IC-ECG) method has been used for the tip location of central venous access devices for the advantage of being safe, accurate and highly cost effective. However, long-term follow-up is rare. This randomized clinical trial aimed to evaluate the long-term complications of peripherally inserted central catheters (PICCs) positioned by the IC-ECG method.
METHODS


We randomized 2250 patients who needed PICC placement to either a landmark length estimation supplemented by IC-ECG positioned group (ECG group) or the traditional landmark length estimation alone group (control group) in a 2:1 allocation. Post-procedural chest X-rays were applied to confirm tip position. Follow-up was performed monthly to six months. Standard statistics analyses were performed with the SAS 9.13 software, and p < 0.05 was considered significant.
RESULTS


As evaluated by post-procedural chest X-ray, tip location in the ECG group had a first-attempt success (catheter tip located at optimal position) of 91.7% (95% confidence interval (CI): 90.3%-93.1%), significantly higher than 78.9% (95% CI: 76.0%-81.9%) observed in the control group (p < 0.001). At six-month follow-up, in the control group, frequency of total complications was 9.5%, including the exit site infection (4.0%), phlebitis (1.3%), deep venous thrombosis (1.5%), liquid extravasation (2.9%) and mechanical failure (1.9%). The IC-ECG group had significantly lower rates of complications (6.4%, p < 0.001), including the exit site infection (2.7%, p > 0.05), phlebitis (1.1%, p > 0.05), deep venous thrombosis (1.2%, p > 0.05), liquid extravasation (2.4%, p > 0.05) and mechanical failure (1.2%, p > 0.05). In the univariable logistic regression analysis, ECG method, other diseases and upper arms were the independent protective factors, and the number of adjustment procedures (n ≥ 2) were the independent risk factors of the complications.
CONCLUSIONS


The intra-procedural tip location by IC-ECG is more safe and accurate than the traditional method of verifying tip location only post-procedurally, by chest X-ray.",2020,"The IC-ECG group had significantly lower rates of complications (6.4%, p < 0.001), including the exit site infection (2.7%, p > 0.05), phlebitis (1.1%, p > 0.05), deep venous thrombosis (1.2%, p > 0.05), liquid extravasation (2.4%, p > 0.05) and mechanical failure (1.2%, p > 0.05).",['2250 patients who needed PICC placement to either a'],"['landmark length estimation supplemented by IC-ECG positioned group (ECG group) or the traditional landmark length estimation alone group (control group', 'peripherally inserted central catheters (PICCs', 'intracavitary electrocardiogram (IC-ECG', 'peripherally inserted central catheters positioned by electrocardiographic technique']","['liquid extravasation', 'exit site infection', 'phlebitis', 'mechanical failure', 'rates of complications', 'deep venous thrombosis', 'frequency of total complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C2049629', 'cui_str': 'PICC Line Catheterization'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1298613', 'cui_str': 'Intracavitary'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0449669', 'cui_str': 'Site of exit'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",2250.0,0.0510363,"The IC-ECG group had significantly lower rates of complications (6.4%, p < 0.001), including the exit site infection (2.7%, p > 0.05), phlebitis (1.1%, p > 0.05), deep venous thrombosis (1.2%, p > 0.05), liquid extravasation (2.4%, p > 0.05) and mechanical failure (1.2%, p > 0.05).","[{'ForeName': 'Yu-Xia', 'Initials': 'YX', 'LastName': 'Yin', 'Affiliation': ""Department of Vascular & Intervention, Tenth Peoples' Hospital of Tongji University, Shanghai, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'PICC Clinic, Qilu Hospital of Shandong University, Jinan, China.'}, {'ForeName': 'Xu-Ying', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Qian-Hong', 'Initials': 'QH', 'LastName': 'Deng', 'Affiliation': 'Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Cui-Yun', 'Initials': 'CY', 'LastName': 'Zhao', 'Affiliation': 'Baotou Cancer Hospital, Baotou, China.'}, {'ForeName': 'Xue-Rong', 'Initials': 'XR', 'LastName': 'Liu', 'Affiliation': 'The First Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Ming-Kun', 'Initials': 'MK', 'LastName': 'Cao', 'Affiliation': 'Affiliated Hospital of Hebei University of Engineering, Handan, China.'}, {'ForeName': 'Lu-Ning', 'Initials': 'LN', 'LastName': 'Wang', 'Affiliation': 'School of Materials Science and Engineering, University of Science and Technology, Beijing, China.'}, {'ForeName': 'Hai-Jun', 'Initials': 'HJ', 'LastName': 'Zhang', 'Affiliation': ""Department of Vascular & Intervention, Tenth Peoples' Hospital of Tongji University, Shanghai, China.""}]",Phlebology,['10.1177/0268355520921357']
55,32383125,Post-exposure prophylaxis or pre-emptive therapy for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): study protocol for a pragmatic randomized-controlled trial.,"BACKGROUND


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


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


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


clinicaltrials.gov (NCT04308668); registered 16 March, 2020.",2020,In-person participant follow-up will not be conducted to facilitate social distancing strategies and reduce risks of exposure to study personnel.,"['severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', 'symptomatic outpatients with COVID-19 showing symptoms for less than four days', '1,500 patients each for the PEP and PET trials']","['hydroxychloroquine or placebo', 'Post-exposure prophylaxis or pre-emptive therapy', 'hydroxychloroquine', 'hydroxychloroquine for post-exposure prophylaxis (PEP) and pre-emptive therapy (PET', 'placebo']","['incidence of symptomatic COVID-19', 'ordinal scale of disease severity (not hospitalized, hospitalized without intensive care, hospitalization with intensive care, or death']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1443861', 'cui_str': 'Post-exposure prophylaxis'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1500.0,0.697151,In-person participant follow-up will not be conducted to facilitate social distancing strategies and reduce risks of exposure to study personnel.,"[{'ForeName': 'Sylvain A', 'Initials': 'SA', 'LastName': 'Lother', 'Affiliation': 'Department of Internal Medicine, Section of Critical Care, University of Manitoba, Winnipeg, MB, Canada. slother@manitoba-physicians.ca.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Abassi', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Agostinis', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Ananta S', 'Initials': 'AS', 'LastName': 'Bangdiwala', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'Divisions of Infectious Diseases & Medical Microbiology, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Drobot', 'Affiliation': 'Department of Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Engen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Kathy H', 'Initials': 'KH', 'LastName': 'Hullsiek', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kelly', 'Affiliation': 'Department of Pediatrics and Child Health, Department of Pharmacology, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Lofgren', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'MacKenzie', 'Affiliation': 'Section of Infectious Diseases, Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Marten', 'Affiliation': 'Critical Care Research, St-Boniface Hospital, Winnipeg, MB, Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Clinical Practice Assessment Unit, Department of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Okafor', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Katelyn A', 'Initials': 'KA', 'LastName': 'Pastick', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Pullen', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Rajasingham', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Schwartz', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Caleb P', 'Initials': 'CP', 'LastName': 'Skipper', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': 'CHU de Québec - Université Laval Research Centre, Population Health and Optimal Health Practices Research Unit Trauma - Emergency - Critical Care Medicine, Université Laval, Quebec, QC, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'Department of Internal Medicine, Section of Critical Care, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Boulware', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN, USA.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01684-7']
56,32380445,Intermittent theta-burst stimulation moderates interaction between increment of N-Acetyl-Aspartate in anterior cingulate and improvement of unipolar depression.,"BACKGROUND


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


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


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


Our findings suggest a potential neurochemical pathway and mechanisms of antidepressant action of iTBS, which may moderate the improvement of metabolic markers of neuronal viability. iTBS might increase neuroplasticity, thus facilitating normalization of neuronal circuit function.",2020,Single-voxel  1 H-MRS of the anterior cingulate cortex (ACC) was performed at baseline and follow-up.,[],"['Intermittent theta-burst stimulation (iTBS', '20 iTBS or sham stimulations applied over left DLPFC', 'repetitive transcranial magnetic stimulation (rTMS) technique', 'Proton magnetic resonance spectroscopy ( 1 H-MRS']","['Cho/NAA ratio', 'NAA change and depression improvement', 'depressive symptoms', 'unipolar depression']",[],"[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}]","[{'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]",,0.0453926,Single-voxel  1 H-MRS of the anterior cingulate cortex (ACC) was performed at baseline and follow-up.,"[{'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Zavorotnyy', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Department of Psychiatry and Psychotherapy, Psychiatric Services Aargau, Academic Hospital of the University of Zurich, Brugg, Switzerland; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany. Electronic address: maxim.zavorotnyy@staff.uni-marburg.de.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Zöllner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Health Protection Authority, Frankfurt, Main, Germany.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Rekate', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Dietsche', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Bopp', 'Affiliation': 'Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany; Department of Neurosurgery, University of Marburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Sommer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Meller', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Krug', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Nenadić', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Germany; Marburg Center for Mind, Brain and Behavior, MCMBB, University of Marburg, Germany.'}]",Brain stimulation,['10.1016/j.brs.2020.03.015']
57,32312527,"Response to Letter to the Editor re 'Volume of water added to crushed ice affects the efficacy of cryotherapy: a randomised, single-blind, crossover trial'.",,2020,,[],['cryotherapy'],[],[],"[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]",[],,0.0262864,,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'de Estéfani', 'Affiliation': 'Federal University of Santa Catarina - Aging, Resources and Rheumatology Laboratory (LERER/UFSC), Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ruschel', 'Affiliation': 'University of the State of Santa Catarina - Health and Sports Science Centre (CEFID/UDESC), Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Inaihá Laureano', 'Initials': 'IL', 'LastName': 'Benincá', 'Affiliation': 'Federal University of Santa Catarina - Aging, Resources and Rheumatology Laboratory (LERER/UFSC), Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Núbia Carelli Pereira', 'Initials': 'NCP', 'LastName': 'de Avelar', 'Affiliation': 'Federal University of Santa Catarina - Aging, Resources and Rheumatology Laboratory (LERER/UFSC), Araranguá, Santa Catarina, Brazil.'}, {'ForeName': 'Daniela Pacheco', 'Initials': 'DP', 'LastName': 'Dos Santos Haupenthal', 'Affiliation': 'University of the Extreme South of Santa Catarina - Laboratory of cellular and molecular biology (LABIM/UNESC), Criciúma, Santa Catarina, Brazil.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Haupenthal', 'Affiliation': 'Federal University of Santa Catarina - Aging, Resources and Rheumatology Laboratory (LERER/UFSC), Araranguá, Santa Catarina, Brazil. Electronic address: alessandro.haupenthal@ufsc.br.'}]",Physiotherapy,['10.1016/j.physio.2020.02.006']
58,32380001,Correction to Lancet Infect Dis 2020; published online March 30. https://doi.org/10.1016/S1473-3099(20)30243-7.,,2020,,[],['https://doi.org/10.1016/S1473-3099(20)30243-7'],[],[],[],[],,0.0193234,,[],The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30368-6']
59,32380069,"Efficacy and safety of azithromycin maintenance therapy in primary ciliary dyskinesia (BESTCILIA): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial.","BACKGROUND


Use of maintenance antibiotic therapy with the macrolide azithromycin is increasing in a number of chronic respiratory disorders including primary ciliary dyskinesia (PCD). However, evidence for its efficacy in PCD is lacking. We aimed to determine the efficacy and safety of azithromycin maintenance therapy for 6 months in patients with PCD.
METHODS


The Better Experimental Screening and Treatment for Primary Ciliary Dyskinesia (BESTCILIA) trial was a multicentre, double-blind, parallel group, randomised, placebo-controlled phase 3 trial done at 6 European PCD clinics (tertiary paediatric care centres and university hospitals in Denmark, Germany, Netherlands, Switzerland, and UK). Patients with a confirmed diagnosis of PCD, aged 7-50 years old, and predicted FEV 1  greater than 40% were recruited. Participants were randomly assigned (1:1), stratified by age and study site, via a web-based randomisation system to azithromycin 250 mg or 500 mg as tablets according to bodyweight (</≥ 40 kg) or identical placebo, three times a week for 6 months. The random allocation sequence was a permuted block randomisation, with a block size of four, generated by an external consultancy. Participants, investigators, and care providers were masked to treatment allocation. The primary endpoint was the number of respiratory exacerbations over 6 months. Analysis was by intention to treat. This study is registered in the EU Clinical Trials Register, EudraCT number 2013-004664-58.
FINDINGS


Between June 24, 2014, and Aug 23, 2016, 102 patients were screened, of whom 90 were randomly assigned to either azithromycin (n=49) or placebo (n=41). The study was ended without having included the planned number of participants due to recruitment difficulties. The mean number of respiratory exacerbations over 6 months was 0·75 (SD 1·12) in the azithromycin group compared with 1·62 (1·64) in the placebo group, and participants receiving azithromycin had significantly lower rate of exacerbations during the individual treatment periods (rate ratio 0·45 [95% CI 0·26-0·78]; p=0·004). Four serious adverse events were reported, occurring in one (2%) of 47 participants in the azithromycin group and in three (7%) of 41 participants in the placebo group. Loose stools or diarrhoea were more common in the azithromycin group than in the placebo group (11 [23%] vs two [5%]).
INTERPRETATION


This first multinational randomised controlled trial on pharmacotherapy in PCD showed that azithromycin maintenance therapy for 6 months was well tolerated and halved the rate of respiratory exacerbations. Azithromycin maintenance therapy is an option for patients with PCD with frequent exacerbations potentially leading to reduced need for additional antibiotic treatments and preventing irreversible lung damage.
FUNDING


European Commission Seventh Framework Programme and Children's Lung Foundation (Denmark).",2020,"Four serious adverse events were reported, occurring in one (2%) of 47 participants in the azithromycin group and in three (7%) of 41 participants in the placebo group.","['primary ciliary dyskinesia (BESTCILIA', 'EudraCT number 2013-004664-58', 'patients with PCD', 'Patients with a confirmed diagnosis of PCD, aged 7-50 years old, and predicted FEV 1  greater than 40% were recruited', '6 European PCD clinics (tertiary paediatric care centres and university hospitals in Denmark, Germany, Netherlands, Switzerland, and UK', 'Between June 24, 2014, and Aug 23, 2016, 102 patients were screened, of whom 90', 'chronic respiratory disorders including primary ciliary dyskinesia (PCD', 'patients with PCD with frequent exacerbations']","['Azithromycin maintenance therapy', 'placebo', 'azithromycin maintenance therapy', 'pharmacotherapy', 'azithromycin', 'azithromycin 250 mg or 500 mg as tablets according to bodyweight (</≥ 40 kg) or identical placebo', 'macrolide azithromycin']","['mean number of respiratory exacerbations', 'rate of respiratory exacerbations', 'Efficacy and safety', 'efficacy and safety', 'rate of exacerbations', 'Loose stools or diarrhoea', 'number of respiratory exacerbations']","[{'cui': 'C4551720', 'cui_str': 'Primary ciliary dyskinesia'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C3839839', 'cui_str': 'Pediatric care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0035204', 'cui_str': 'Disorder of respiratory system'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0983950', 'cui_str': 'Azithromycin 250 MG'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0003240', 'cui_str': 'Macrolide antibiotic product'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",102.0,0.744903,"Four serious adverse events were reported, occurring in one (2%) of 47 participants in the azithromycin group and in three (7%) of 41 participants in the placebo group.","[{'ForeName': 'Helene E', 'Initials': 'HE', 'LastName': 'Kobbernagel', 'Affiliation': 'Danish Primary Ciliary Dyskinesia Centre, Paediatric Pulmonary Service, Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Frederik F', 'Initials': 'FF', 'LastName': 'Buchvald', 'Affiliation': 'Danish Primary Ciliary Dyskinesia Centre, Paediatric Pulmonary Service, Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Eric G', 'Initials': 'EG', 'LastName': 'Haarman', 'Affiliation': ""Department of Pediatric Pulmonology, Emma Children's Hospital, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Netherlands.""}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Casaulta', 'Affiliation': 'Division of Respiratory Medicine, Department of Pediatrics, Inselspital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'Collins', 'Affiliation': 'Primary Ciliary Dyskinesia Centre, National Institute for Health Research Biomedical Research Centre, University of Southampton, Southampton, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hogg', 'Affiliation': 'Primary Ciliary Dyskinesia Centre, Paediatric Respiratory Department, Royal Brompton Hospital, London, UK.'}, {'ForeName': 'Claudia E', 'Initials': 'CE', 'LastName': 'Kuehni', 'Affiliation': 'Division of Respiratory Medicine, Department of Pediatrics, Inselspital and University of Bern, Bern, Switzerland; Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Jane S', 'Initials': 'JS', 'LastName': 'Lucas', 'Affiliation': 'Primary Ciliary Dyskinesia Centre, National Institute for Health Research Biomedical Research Centre, University of Southampton, Southampton, UK.'}, {'ForeName': 'Claus E', 'Initials': 'CE', 'LastName': 'Moser', 'Affiliation': 'Department of Clinical Microbiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Quittner', 'Affiliation': ""Nicklaus Children's Research Institute, Miami, FL, USA.""}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Raidt', 'Affiliation': ""Department of General Pediatrics, University Children's Hospital Muenster, Muenster, Germany.""}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Rosthøj', 'Affiliation': 'Section of Biostatistics, Department of Public Health, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Sørensen', 'Affiliation': 'Section of Biostatistics, Department of Public Health, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Thomsen', 'Affiliation': 'Department of Clinical Microbiology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Werner', 'Affiliation': ""Helios Children's Hospital Schwerin, Schwerin, Germany; Department of General Pediatrics, University Children's Hospital Muenster, Muenster, Germany.""}, {'ForeName': 'Heymut', 'Initials': 'H', 'LastName': 'Omran', 'Affiliation': ""Department of General Pediatrics, University Children's Hospital Muenster, Muenster, Germany.""}, {'ForeName': 'Kim G', 'Initials': 'KG', 'LastName': 'Nielsen', 'Affiliation': 'Danish Primary Ciliary Dyskinesia Centre, Paediatric Pulmonary Service, Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. Electronic address: kim.g.nielsen@regionh.dk.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30058-8']
60,32380138,Reduced tactile acuity in chronic low back pain is linked with structural neuroplasticity in primary somatosensory cortex and is modulated by acupuncture therapy.,"Prior studies have shown that patients suffering from chronic Low Back Pain (cLBP) have impaired somatosensory processing including reduced tactile acuity, i.e. reduced ability to resolve fine spatial details with the perception of touch. The central mechanism(s) underlying reduced tactile acuity are unknown but may include changes in specific brain circuitries (e.g. neuroplasticity in the primary somatosensory cortex, S1). Furthermore, little is known about the linkage between changes in tactile acuity and the amelioration of cLBP by somatically-directed therapeutic interventions, such as acupuncture. In this longitudinal neuroimaging study, we evaluated healthy control adults (HC, N ​= ​50) and a large sample of cLBP patients (N ​= ​102) with structural brain imaging (T1-weighted MRI for Voxel-Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT) over the lower back (site of pain) and finger (control) locations. Patients were evaluated at baseline and following a 4-week course of acupuncture, with patients randomized to either verum acupuncture, two different forms of sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control. At baseline, cLBP patients demonstrated reduced acuity (greater 2PDT, P ​= ​0.01) over the low back, but not finger (P ​= ​0.29) locations compared to HC, suggesting that chronic pain affects tactile acuity specifically at body regions encoding the experience of clinical pain. At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P ​< ​0.05). GMV in cLBP correlated with greater 2PDT-back scores (ρ ​= ​0.27, P ​= ​0.02). Following verum acupuncture, tactile acuity over the back was improved (reduced 2PDT) and greater improvements were associated with reduced S1-back GMV (ρ ​= ​0.52, P ​= ​0.03) and increased S1-back adjacent white matter FA (ρ ​= ​-0.56, P ​= ​0.01). These associations were not seen for non-verum control interventions. Thus, S1 neuroplasticity in cLBP is linked with deficits in tactile acuity and, following acupuncture therapy, may represent early mechanistic changes in somatosensory processing that track with improved tactile acuity.",2020,"At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P<0.05).","['patients suffering from chronic Low Back Pain (cLBP', 'healthy control adults (HC, N=50) and a large sample of cLBP patients (N=102) with']","['acupuncture', 'structural brain imaging (T1-weighted MRI for Voxel Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT', 'verum acupuncture', 'sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control']","['tactile acuity', 'S1-back adjacent white matter FA', '2PDT-back scores', 'Fractional Anisotropy (FA', 'tactile acuity over the back was improved (reduced 2PDT', 'reduced S1-back GMV', 'reduced acuity', 'Gray Matter Volume (GMV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0203860', 'cui_str': 'Imaging of brain'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4523852', 'cui_str': 'Voxel-based morphometry'}, {'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",102.0,0.102659,"At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P<0.05).","[{'ForeName': 'Hyungjun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Division of Clinical Medicine, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea.'}, {'ForeName': 'Ishtiaq', 'Initials': 'I', 'LastName': 'Mawla', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jeungchan', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gerber', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Walker', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Division of Clinical Medicine, Korea Institute of Oriental Medicine, Daejeon, 34054, South Korea.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Suk-Tak', 'Initials': 'ST', 'LastName': 'Chan', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Marco L', 'Initials': 'ML', 'LastName': 'Loggia', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Ajay D', 'Initials': 'AD', 'LastName': 'Wasan', 'Affiliation': 'Department of Anesthesiology, Center for Pain Research, University of Pittsburgh, Pittsburgh, PA, 15261, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 02115, USA.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Program in Placebo Studies & Therapeutic Encounter (PiPS), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, 02115, USA.'}, {'ForeName': 'Randy L', 'Initials': 'RL', 'LastName': 'Gollub', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Rosen', 'Affiliation': 'Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA.'}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': ""Department of Radiology, Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, 02129, USA; Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 02115, USA. Electronic address: vitaly@mgh.harvard.edu.""}]",NeuroImage,['10.1016/j.neuroimage.2020.116899']
61,32379483,A Sensory Stimulation Protocol to Modulate Cough Sensitivity: A Randomized Controlled Trial Safety Study.,"Purpose This study evaluated the safety and efficacy of a sensory stimulation protocol that was designed to modulate citric acid cough thresholds as a potential treatment for silent aspiration. Method Healthy adults ( n  = 24) were randomly assigned to one of three sensory stimulation groups: (a) high-intensity ultrasonically nebulized distilled water (UNDW) inhalations (1.6 ml/min); (b) low-intensity UNDW inhalations (0.5 ml/min); and (3) control, 0.9% saline inhalations (1.6 ml/min). Sensory stimulation was delivered once a day, for 4 consecutive days. Citric acid cough thresholds were determined at baseline, Day 3, and Day 5 to evaluate changes in cough sensitivity. Spirometry was undertaken before, during, and after each sensory stimulation session to monitor for bronchoconstriction. Results No participant showed evidence of bronchoconstriction during the sensory stimulation protocol. There was an interaction effect between day and group on suppressed cough thresholds, χ 2 (4) = 11.32,  p  = .02. When compared to the control group, there was a decrease in citric acid cough thresholds across Days 1-5 in the high-intensity (-1.8 doubling concentrations, 95% confidence interval [-2.88, -0.72],  p  = .01) and low-intensity (-1.3 doubling concentrations, 95% confidence interval [-2.4, -0.2],  p  = .03) UNDW inhalation groups, representing a sensitization effect of UNDW inhalations on cough sensitivity. Conclusions The UNDW sensory stimulation protocol was safe in healthy adults. The findings provide preliminary evidence that UNDW inhalations sensitize laryngeal afferents related to citric acid-induced cough induction. The therapeutic potential of the UNDW sensory stimulation protocol will be explored in patients with reduced cough sensitivity who are at risk of silent aspiration and aspiration pneumonia. Plain Language Summary This study explored the safety and efficacy of a sensory stimulation protocol that was designed to modulate cough sensitivity as a potential treatment for silent aspiration. The study revealed that inhalations of nebulized distilled water were safe and increased cough sensitivity, when compared to control saline inhalations.",2020,"The study revealed that inhalations of nebulized distilled water were safe and increased cough sensitivity, when compared to control saline inhalations.","['Method Healthy adults ( n  = 24', 'silent aspiration', 'healthy adults', 'patients with reduced cough sensitivity who are at risk of silent aspiration and aspiration pneumonia']","['Sensory Stimulation Protocol', 'sensory stimulation groups: (a) high-intensity ultrasonically nebulized distilled water (UNDW) inhalations (1.6 ml/min); (b) low-intensity UNDW inhalations', 'UNDW inhalations', 'sensory stimulation protocol']","['bronchoconstriction', 'Cough Sensitivity', 'cough sensitivity', 'safety and efficacy', 'Citric acid cough thresholds', 'safe and increased cough sensitivity', 'citric acid cough thresholds', 'low-intensity']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4324315', 'cui_str': 'Silent aspiration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}]","[{'cui': 'C0150763', 'cui_str': 'Sensory stimulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0079043', 'cui_str': 'Bronchial Constriction'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]",24.0,0.0962598,"The study revealed that inhalations of nebulized distilled water were safe and increased cough sensitivity, when compared to control saline inhalations.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Wallace', 'Affiliation': 'Department of Communication Disorders, Rose Centre for Stroke Recovery and Research, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Guiu Hernandez', 'Affiliation': 'Department of Communication Disorders, Rose Centre for Stroke Recovery and Research, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Epton', 'Affiliation': 'Canterbury Respiratory Research Group, Christchurch Hospital, New Zealand.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ploen', 'Affiliation': 'Respiratory Physiology Laboratory, Christchurch Hospital, New Zealand.'}, {'ForeName': 'Maggie-Lee', 'Initials': 'ML', 'LastName': 'Huckabee', 'Affiliation': 'Department of Communication Disorders, Rose Centre for Stroke Recovery and Research, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Macrae', 'Affiliation': 'Department of Communication Disorders, Rose Centre for Stroke Recovery and Research, University of Canterbury, Christchurch, New Zealand.'}]",American journal of speech-language pathology,['10.1044/2020_AJSLP-19-00180']
62,32384461,Efficacy of needle-knife combined with etanercept treatment regarding disease activity and hip joint function in ankylosing spondylitis patients with hip joint involvement: A randomized controlled study.,"This study aimed to assess the efficacy of needle-knife (NK) combined with etanercept (NKCE) in attenuating pain, inflammation, disease activity, and improving hip joint function in ankylosing spondylitis (AS) patients with hip joint involvement.Totally, 90 patients with active AS involving unilateral hip joint were enrolled and randomly assigned in 1:1:1 ratio to receive NKCE, NK or conventional drugs (control). The ESR, CRP, hip joint pain Visual Analogue Scale (VAS) score, bath ankylosing spondylitis disease activity index (BASDAI), bath ankylosing spondylitis functional index (BASFI), modified Harris hip score (mHHS), and range of motion (ROM) of affected hip joint were assessed at baseline (W0), after 1-week treatment (W1) and after 24-week treatment (W24).ESR and CRP were decreased in NKCE group compared with NK and control groups, while was not attenuated in NK group compared with control group. Regrading pain and disease activity, NKCE group presented a reduction in hip pain VAS score and BASDAI compared with NK and control groups, and NK group showed a decrease in hip pain VAS score and BASDAI compared with control group. Besides, BASFI was lowered in NKCE and NK groups compared with control group, but similar between NKCE and NK groups. mHHS and hip ROM were raised in NKCE and NK groups compared with control group, but similar between NKCE and NK groups.NKCE decreases hip pain, inflammation, disease activity and improves hip joint function in AS patients with hip joint involvement.",2020,"mHHS and hip ROM were raised in NKCE and NK groups compared with control group, but similar between NKCE and NK groups.","['90 patients with active AS involving unilateral hip joint', 'ankylosing spondylitis (AS) patients with hip joint involvement', 'AS patients with hip joint involvement', 'ankylosing spondylitis patients with hip joint involvement']","['needle-knife combined with etanercept', 'needle-knife (NK) combined with etanercept (NKCE', 'NKCE, NK or conventional drugs (control', 'NKCE']","['pain, inflammation, disease activity', 'BASFI', 'mHHS and hip ROM', 'Regrading pain and disease activity', 'disease activity and hip joint function', 'hip pain, inflammation, disease activity and improves hip joint function', 'hip pain VAS score and BASDAI', 'ESR, CRP, hip joint pain Visual Analogue Scale (VAS) score, bath ankylosing spondylitis disease activity index (BASDAI), bath ankylosing spondylitis functional index (BASFI), modified Harris hip score (mHHS), and range of motion (ROM) of affected hip joint']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}]","[{'cui': 'C0181464', 'cui_str': 'Needle knife'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}, {'cui': 'C2363836', 'cui_str': 'Natural killer cell count'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1998004', 'cui_str': 'Bath ankylosing spondylitis disease activity index'}, {'cui': 'C0013845', 'cui_str': 'Electron spin resonance measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}]",90.0,0.0265861,"mHHS and hip ROM were raised in NKCE and NK groups compared with control group, but similar between NKCE and NK groups.","[{'ForeName': 'Yuquan', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'School of Biomedical Sciences, Huaqiao University.'}, {'ForeName': 'Meimei', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': 'Department of Ankylosing Spondylitis, Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University, Quanzhou, China.'}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'School of Biomedical Sciences, Huaqiao University.'}, {'ForeName': 'Lianqun', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Ankylosing Spondylitis, Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University, Quanzhou, China.'}, {'ForeName': 'Changxian', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Ankylosing Spondylitis, Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University, Quanzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'School of Biomedical Sciences, Huaqiao University.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Ankylosing Spondylitis, Quanzhou Orthopedic-Traumatological Hospital of Fujian Traditional Chinese Medicine University, Quanzhou, China.'}]",Medicine,['10.1097/MD.0000000000020019']
63,32384509,To explore the clinical efficacy of Traditional Chinese Medicine bath in the treatment of psoriasis vulgaris with blood-heat syndrome and its effect on related cytokines based on different temperature and different concentration.,"BACKGROUND


Chinese herbal bath has long been used in the curative treatment of psoriasis vulgaris. However, there is no unified standard protocol for Chinese herbal bath. Many factors affect the curative effect of Chinese herbal bath, such as water temperature, bath concentration, and soaking time. Most studies involving Chinese herbal bath has described the bath generally, and few studies have investigated the factors that might contribute to the efficacy of Chinese herbal bath. Here we describe a protocol to evaluate the efficacy and safety of various bathwater temperatures and herbal concentrations on psoriasis vulgaris, and their effect on serum vascular endothelial growth factor (VEGF), tumor necrosis factor α (TNF-α), interleukin 23 (IL-23), and interleukin 17 (IL-17). These data could be useful for optimizing Chinese herbal bath treatments.
METHODS


In this randomized controlled trial, we planned to recruit 288 hospitalized atients with psoriasis vulgaris aged 18 to 65 years. All participants who meet the inclusion criteria will be randomly assigned to the observation group, the control group, or the basic treatment group. The observation group will be divided into 6 sub-groups according to water temperatures and bath concentrations, designated as observation groups 1 to 6. Thirty-six participants will be assigned to each group. The basic treatment group will be given co-qingdai capsule, po 2 g tid; compound glycyrrhizin tablet, po 75 mg tid; AA Skincare jojoba Oil, us.ext qd. The observation group will be given a Chinese herbal bath at the same time as the basic treatment. The control group will be given ozone hydrotherapy at the same time as the basic treatment. The entire treatment course will last for 2 weeks. The following parameters will be compared in each group, before and 2 weeks after treatment: the psoriasis area and severity index score (PASI), pruritus score, clinical efficacy, and dermatology life quality index score (DLQI); serum levels of serum VEGF, TNF-α, IL-23, and IL-17; and confocal laser scanning microscope images.
CONCLUSION


This study will evaluate the efficacy and safety of various Chinese herbal bath conditions (water temperatures and herbal concentrations) on the treatment of psoriasis vulgaris, which will provide an important reference for the operation of Chinese herbal bath.
TRIAL REGISTRATION NUMBER


ChiCTR1900027468.",2020,"The following parameters will be compared in each group, before and 2 weeks after treatment: the psoriasis area and severity index score (PASI), pruritus score, clinical efficacy, and dermatology life quality index score (DLQI); serum levels of serum VEGF, TNF-α, IL-23, and IL-17; and confocal laser scanning microscope images.
","['288 hospitalized atients with psoriasis vulgaris aged 18 to 65 years', 'psoriasis vulgaris with blood-heat syndrome']","['Traditional Chinese Medicine bath', 'glycyrrhizin tablet, po 75\u200amg tid; AA Skincare jojoba Oil, us.ext qd', 'ozone hydrotherapy', 'various Chinese herbal bath conditions (water temperatures and herbal concentrations']","['efficacy and safety', 'serum vascular endothelial growth factor (VEGF), tumor necrosis factor α (TNF-α), interleukin 23 (IL-23), and interleukin 17 (IL-17', 'psoriasis area and severity index score (PASI), pruritus score, clinical efficacy, and dermatology life quality index score (DLQI); serum levels of serum VEGF, TNF-α, IL-23, and IL-17; and confocal laser scanning microscope images']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0061751', 'cui_str': 'Glycyrrhizic Acid'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0064161', 'cui_str': 'jojoba wax'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C4706308', 'cui_str': 'DLQI (Dermatology Life Quality Index) score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0181839', 'cui_str': 'Microscope'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]",36.0,0.0598044,"The following parameters will be compared in each group, before and 2 weeks after treatment: the psoriasis area and severity index score (PASI), pruritus score, clinical efficacy, and dermatology life quality index score (DLQI); serum levels of serum VEGF, TNF-α, IL-23, and IL-17; and confocal laser scanning microscope images.
","[{'ForeName': 'Wenxia', 'Initials': 'W', 'LastName': 'Lin', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Qianying', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Yuesi', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'School of Clinical Medicine, Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': 'Chengdu Yinkang Psoriasis Hospital, Chengdu, Sichuan Province, PR China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': 'Chengdu Yinkang Psoriasis Hospital, Chengdu, Sichuan Province, PR China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Jiao', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Shengzhen', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Jiahao', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Mingling', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, Hospital of Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000020172']
64,32380449,Effects of high-frequency repetitive transcranial magnetic stimulation over the contralesional motor cortex on motor recovery in severe hemiplegic stroke: A randomized clinical trial.,"BACKGROUND


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


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


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


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


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


Clinical trial registered with the Chinese Clinical Trial Registry at http://www.chictr.org.cn/showproj.aspx?proj=23264 (ChiCTR-IPR-17013580).",2020,"The HF group showed a more significant improvement in FMA score (p < 0.05), BI (p < 0.005), contralesional hemisphere cortical excitability and conductivity (p < 0.05), and RMS-SEMG of the key muscles (p < 0.05) compared with the LF group and sham group.","['severe hemiplegic stroke', 'Forty-five patients with ischemic or hemorrhagic stroke in the middle cerebral artery territory', 'patients with severe hemiplegic stroke', 'severe stroke patients']","['high-frequency repetitive transcranial magnetic stimulation', 'HF-rTMS', 'high-frequency rTMS (HF-rTMS', 'repetitive transcranial magnetic stimulation (rTMS', '10\xa0Hz rTMS (HF group), 1\xa0Hz rTMS (LF group) or sham rTMS (sham group) applied over the contralesional motor cortex (M1) before physiotherapy daily for two weeks']","['FMA score', 'root mean square of surface electromyography (RMS-SEMG), Barthel Index (BI), and contralesional hemisphere cortical excitability', 'change in the Fugl-Meyer Motor Assessment (FMA) Scale score', 'cortical conductivity of the uninjured hemisphere and recovery of motor impairment', 'contralesional hemisphere cortical excitability and conductivity', 'RMS-SEMG of the key muscles']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}]","[{'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0430815', 'cui_str': 'Surface EMG'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0013777', 'cui_str': 'Electrical Conductivity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",45.0,0.537609,"The HF group showed a more significant improvement in FMA score (p < 0.05), BI (p < 0.005), contralesional hemisphere cortical excitability and conductivity (p < 0.05), and RMS-SEMG of the key muscles (p < 0.05) compared with the LF group and sham group.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Ying-Yu', 'Initials': 'YY', 'LastName': 'Zhao', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Hai', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yue-Wen', 'Initials': 'YW', 'LastName': 'Ma', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of China Medical University, Shenyang, China. Electronic address: mayw@cmu1h.com.'}]",Brain stimulation,['10.1016/j.brs.2020.03.020']
65,32384495,"A simple, efficient, and safe way of finding recurrent laryngeal nerve beneficial for PTC patients.","BACKGROUND


More surgeons have known the importance of parathyroid grand and recurrent laryngeal nerve protection in the surgery, but there is still plenty of scope to improve the surgical techniques. This study aims at investigating whether the improved method of finding recurrent laryngeal nerve (RLN) can protect parathyroid grand and RLN.
METHODS


One hundred fifty-eight patients were enrolled and divided randomly into the test and control group according to different methods of finding RLN in the surgery. In the experimental group the author could quickly find the laryngeal recurrent nerve in the lower part of the neck and separate along the surface of the recurrent laryngeal nerve to the point where the recurrent laryngeal nerve gets into the larynx close to the thyroid gland named lateral approach, while in the control group the author severed the middle and lower thyroid vein and raised the lower thyroid pole to look for the RLN near the trachea by the blunt separation.
RESULTS


The author identified 152 and 159 parathyroid glands in the test and control group, respectively and there were a lower ratio of auto-transplantation and less operative time in the test group compared with that in the control group. The author also found that the parathyroid hormone level (1 day and 2 months) in the test group was higher than that in the control group. There were no differences in metastatic LN and recurrent laryngeal nerve palsy in the 2 groups.
CONCLUSION


The improved method of finding RLN is a simple, efficient and safe way, and easy to implement.",2020,"There were no differences in metastatic LN and recurrent laryngeal nerve palsy in the 2 groups.
",['One hundred fifty-eight patients'],[],"['metastatic LN and recurrent laryngeal nerve palsy', 'parathyroid hormone level', 'lower ratio of auto-transplantation and less operative time']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0542142', 'cui_str': 'Vagus nerve laryngeal paralysis'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",158.0,0.0184314,"There were no differences in metastatic LN and recurrent laryngeal nerve palsy in the 2 groups.
","[{'ForeName': 'Shouyi', 'Initials': 'S', 'LastName': 'Yan', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}, {'ForeName': 'Liyong', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Vascular Surgery.'}]",Medicine,['10.1097/MD.0000000000020138']
66,32384500,Multiple versus single doses of dexamethasone in total hip arthroplasty: A protocol of randomized controlled trial.,"BACKGROUND


Reduction of post-operative pain, nausea, and vomiting in patients undergoing total hip arthroplasty (THA) may facilitate earlier discharge from hospital and reduce healthcare costs. The recommended dose regimen of dexamethasone in THA has not been determined. The purpose of this study was performed to compare the efficiency of multiple versus single doses of dexamethasone for early postoperative pain treatment after THA.
METHODS


This study was a randomized controlled trial which conducted in our hospital. Informed consent for participation in this trial was obtained from each patient before surgery. Two hundred patients undergoing THA received 1 dose of intravenous dexamethasone and 1 dose of normal saline (Group A), or 2 doses of intravenous dexamethasone (Group B). The primary outcome was visual analog scale pain scores in the immediate postoperative period. Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and hip range of motion.
RESULTS


This clinical trial might provide some insights to estimate the safety of dexamethasone.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5460).",2020,"Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and hip range of motion.
","['Two hundred patients undergoing', 'early postoperative pain treatment after THA', 'patients undergoing total hip arthroplasty (THA', 'total hip arthroplasty']","['dexamethasone', 'normal saline', 'intravenous dexamethasone', 'THA']","['postoperative opioid use, length of hospital stay, activity level during physical therapy, and hip range of motion', 'visual analog scale pain scores']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",200.0,0.478323,"Secondary outcomes included postoperative opioid use, length of hospital stay, activity level during physical therapy, and hip range of motion.
","[{'ForeName': 'Bangjian', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology.'}, {'ForeName': 'Shaoqiong', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Department of Operation room, Panzhihua Central Hospital.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Sheng', 'Affiliation': 'Department of Anesthesiology, West China Second University Hospital, Sichuan University, Sichuan Province, China.'}]",Medicine,['10.1097/MD.0000000000020147']
67,32385061,"Effect of PIFR-based optimised inhalation therapy in patients recovering from acute exacerbation of chronic obstructive pulmonary disease: protocol of a prospective, multicentre, superiority, randomised controlled trial.","INTRODUCTION


Acute exacerbation (AE) is a major cause of disease progression and death in patients with chronic obstructive pulmonary disease (COPD), accounting for majority of medical expenditures. Correct inhalation therapy is effective in preventing AE attacks. However, inappropriate usage of dry powder inhaler, partially due to the unrecovered peak inhalation flow rate (PIFR) after acute exacerbation of COPD (AECOPD), results in increased risk of early treatment failure. Therefore, we designed a multicentre, randomised clinical trial to determine whether PIFR-based optimised inhalation therapy and training on inhaler usage at discharge could effectively reduce early treatment failure events.
METHODS AND ANALYSIS


A total of 416 hospitalised patients just recovering from AECOPD will be recruited and equally randomised into the PIFR group and the control group at a 1:1 ratio. The PIFR group will receive additive support before discharge, including choice of PIFR-guided inhaler and education on its usage. PIFR is measured by InCheck DIAL. In comparison, the control group will receive inhalers based on judgement of the respiratory physician. The primary outcome of the study is 30-day treatment failure rate. Other endpoints include PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs.
ETHICS AND DISSEMINATION


The trial has been approved by the Ethics Committee of Zhongshan Hospital of Fudan University (B2019-142). Participants will be screened and enrolled from hospitalised patients with AECOPD by clinicians, with no public advertisement for recruitment. After the trial has completed, the results will be reported to the public through conference presentations and peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT04000958.",2020,"Other endpoints include PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs.
","['patients with chronic obstructive pulmonary disease (COPD', 'Participants will be screened and enrolled from hospitalised patients with AECOPD by clinicians, with no public advertisement for recruitment', '416 hospitalised patients just recovering from AECOPD', 'patients recovering from acute exacerbation of chronic obstructive pulmonary disease']","['PIFR-based optimised inhalation therapy and training', 'PIFR-based optimised inhalation therapy']","['30-day treatment failure rate', 'risk of early treatment failure', 'PIFR', 'peak inhalation flow rate (PIFR', 'PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021459', 'cui_str': 'Inhalation therapy procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021455', 'cui_str': 'Inhalation Devices'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}]",416.0,0.260112,"Other endpoints include PIFR, error rate of inhalation device use, satisfaction with inhalation devices, 30-day mortality, 90-day mortality, symptoms and quality of life of patients, and COPD-related treatment costs.
","[{'ForeName': 'Jianlan', 'Initials': 'J', 'LastName': 'Hua', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Fudan University, Shanghai, China.'}, {'ForeName': 'Hui-Fang', 'Initials': 'HF', 'LastName': 'Cao', 'Affiliation': ""Department of Pulmonary, Shanghai Jing'an District Central Hospital, Shanghai, China, Shanghai, China.""}, {'ForeName': 'Chun-Ling', 'Initials': 'CL', 'LastName': 'Du', 'Affiliation': 'Department of Pulmonary, Shanghai Qingpu District Central Hospital, Shanghai, China.'}, {'ForeName': 'Jia-Yun', 'Initials': 'JY', 'LastName': 'Ma', 'Affiliation': ""Department of Pulmonary, North Branch of Shanghai Ninth People's Hospital, Shanghai, China.""}, {'ForeName': 'Yi-Hui', 'Initials': 'YH', 'LastName': 'Zuo', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China jingatlas@hotmail.com.'}]",BMJ open,['10.1136/bmjopen-2019-034804']
68,32385158,Common and dissociable effects of oxytocin and lorazepam on the neurocircuitry of fear.,"Benzodiazepines (BZDs) represent the gold standard of anxiolytic pharmacotherapy; however, their clinical benefit is limited by side effects and addictive potential. Consequently, there is an urgent need to develop novel and safe anxiolytics. The peptide hormone oxytocin (OXT) exhibits anxiolytic-like properties in animals and humans, but whether OXT and BZDs share similar effects on the neural circuitry of fear is unclear. Therefore, the rationale of this ultra-high-field functional MRI (fMRI) study was to test OXT against the clinical comparator lorazepam (LZP) with regard to their neuromodulatory effects on local and network responses to fear-related stimuli. One hundred twenty-eight healthy male participants volunteered in this randomized double-blind, placebo-controlled, between-group study. Before scanning using an emotional face-matching paradigm, participants were randomly administered a single dose of OXT (24 IU), LZP (1 mg), or placebo. On the behavioral level, LZP, but not OXT, caused mild sedation, as evidenced by a 19% increase in reaction times. On the neural level, both OXT and LZP inhibited responses to fearful faces vs. neutral faces within the centromedial amygdala (cmA). In contrast, they had different effects on intra-amygdalar connectivity; OXT strengthened the coupling between the cmA and basolateral amygdala, whereas LZP increased the interplay between the cmA and superficial amygdala. Furthermore, OXT, but not LZP, enhanced the coupling between the cmA and the precuneus and dorsomedial prefrontal cortex. These data implicate inhibition of the cmA as a common denominator of anxiolytic action, with only OXT inducing large-scale connectivity changes of potential therapeutic relevance.",2020,"On the neural level, both OXT and LZP inhibited responses to fearful faces vs. neutral faces within the centromedial amygdala (cmA).",['One hundred twenty-eight healthy male participants volunteered'],"['Benzodiazepines (BZDs', 'oxytocin and lorazepam', 'OXT', 'LZP', 'peptide hormone oxytocin (OXT', 'lorazepam (LZP', 'placebo']","['neurocircuitry of fear', 'reaction times']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0597192', 'cui_str': 'Peptide hormone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",128.0,0.100533,"On the neural level, both OXT and LZP inhibited responses to fearful faces vs. neutral faces within the centromedial amygdala (cmA).","[{'ForeName': 'Ann-Kathrin', 'Initials': 'AK', 'LastName': 'Kreuder', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Schultz', 'Affiliation': 'Center for Economics and Neuroscience, University of Bonn, 53113 Bonn, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Hennig', 'Affiliation': 'Division of Personality Psychology and Individual Differences, University of Giessen, 35390 Giessen, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Marsh', 'Affiliation': 'Department of Psychiatry, School of Medicine & Health Sciences, University of Oldenburg, 26129 Oldenburg, Germany.'}, {'ForeName': 'Torge', 'Initials': 'T', 'LastName': 'Dellert', 'Affiliation': 'Institute of Medical Psychology and Systems Neuroscience, University of Muenster, 48149 Muenster, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Ettinger', 'Affiliation': 'Department of Psychology, University of Bonn, 53113 Bonn, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Philipsen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Babasiz', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Herscheid', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Remmersmann', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Ruediger', 'Initials': 'R', 'LastName': 'Stirnberg', 'Affiliation': 'Division of MR Physics, German Center for Neurodegenerative Diseases, 53175 Bonn, Germany.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Stöcker', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Division of Medical Psychology, Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany; renehurlemann@icloud.com.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1920147117']
69,32390503,Handling missing data in modelling quality of clinician-prescribed routine care: Sensitivity analysis of departure from missing at random assumption.,"Missing information is a major drawback in analyzing data collected in many routine health care settings. Multiple imputation assuming a missing at random mechanism is a popular method to handle missing data. The missing at random assumption cannot be confirmed from the observed data alone, hence the need for sensitivity analysis to assess robustness of inference. However, sensitivity analysis is rarely conducted and reported in practice. We analyzed routine paediatric data collected during a cluster randomized trial conducted in Kenyan hospitals. We imputed missing patient and clinician-level variables assuming the missing at random mechanism. We also imputed missing clinician-level variables assuming a missing not at random mechanism. We incorporated opinions from 15 clinical experts in the form of prior distributions and shift parameters in the delta adjustment method. An interaction between trial intervention arm and follow-up time, hospital, clinician and patient-level factors were included in a proportional odds random-effects analysis model. We performed these analyses using R functions derived from the  jomo  package. Parameter estimates from multiple imputation under the missing at random mechanism were similar to multiple imputation estimates assuming the missing not at random mechanism. Our inferences were insensitive to departures from the missing at random assumption using either the prior distributions or shift parameters sensitivity analysis approach.",2020,Our inferences were insensitive to departures from the missing at random assumption using either the prior distributions or shift parameters sensitivity analysis approach.,['Kenyan hospitals'],[],[],"[{'cui': 'C0337839', 'cui_str': 'Kenyans'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],[],,0.0221474,Our inferences were insensitive to departures from the missing at random assumption using either the prior distributions or shift parameters sensitivity analysis approach.,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gachau', 'Affiliation': 'Health Services Unit, Kenya Medical Research Institute-Wellcome Trust Research Programme, Nairobi, Kenya.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Quartagno', 'Affiliation': 'Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Edmund Njeru', 'Initials': 'EN', 'LastName': 'Njagi', 'Affiliation': 'Department of Non-Communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Owuor', 'Affiliation': 'School of Mathematics, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'English', 'Affiliation': 'Health Services Unit, Kenya Medical Research Institute-Wellcome Trust Research Programme, Nairobi, Kenya.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Ayieko', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}]",Statistical methods in medical research,['10.1177/0962280220918279']
70,32386476,The relationship between postoperative opioid consumption and the incidence of hypoxemic events following total hip arthroplasty: a post hoc analysis.,"Background


Postoperative opioid analgesia may cause respiratory depression. We assessed whether following total hip arthroplasty, placebo-adjusted reductions in morphine consumption at 48 hours with parecoxib (47.0%), propacetamol (35.1%) or parecoxib plus propacetamol (67.9%) translated into a reduction in hypoxemic events.
Methods


This was a post hoc analysis of a randomized, placebo-controlled, noninferiority study. Patients were randomly assigned to receive intravenous parecoxib (40 mg twice daily), propacetamol (2 g 4 times daily), parecoxib plus propacetamol (40 mg twice daily + 2 g 4 times daily) or placebo. Dose, date and time of morphine administration via patient-controlled analgesia were monitored throughout the study. In patients not receiving supplemental oxygen, peripheral blood oxygenation was assessed continuously for 48 hours after surgery. Hypoxemia was defined as peripheral oxygen saturation less than 90%. The times and oximeter readings of hypoxemic events were recorded. Pearson correlation coefficient was used to assess for correlations between cumulative morphine consumption at 48 hours and mean number of hypoxemic events.
Results


A significantly smaller proportion of patients who received the combined treatment with parecoxib and propacetamol had hypoxemia versus placebo (2.8% v. 13.2%, p < 0.05), and the mean number of hypoxemic events was significantly smaller for parecoxib (0.12), propacetamol (0.06) and parecoxib plus propacetamol (0.03) versus placebo (0.36; all p < 0.05). There was no correlation between the reduction in cumulative morphine consumption at 48 hours and the mean number of hypoxemic events in any treatment group (all p > 0.1).
Conclusion


Following total hip arthroplasty, a greater than 70% reduction in morphine consumption may be necessary to translate into a corresponding reduction in hypoxemic events.",2020,"A significantly smaller proportion of patients who received the combined treatment with parecoxib and propacetamol had hypoxemia versus placebo (2.8% v. 13.2%, p < 0.05), and the mean number of hypoxemic events was significantly smaller for parecoxib (0.12), propacetamol (0.06) and parecoxib plus propacetamol (0.03) versus placebo (0.36; all p < 0.05).",['total hip arthroplasty'],"['parecoxib plus propacetamol', 'morphine', 'intravenous parecoxib', 'total hip arthroplasty, placebo', 'parecoxib', 'placebo']","['peripheral oxygen saturation less', 'mean number of hypoxemic events', 'hypoxemia', 'cumulative morphine consumption', 'morphine consumption', 'Hypoxemia', 'times and oximeter readings of hypoxemic events', 'hypoxemic events', 'peripheral blood oxygenation']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0915142', 'cui_str': 'parecoxib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0084186', 'cui_str': 'propacetamol'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0182117', 'cui_str': 'Oxygen analyzer'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}]",,0.254389,"A significantly smaller proportion of patients who received the combined treatment with parecoxib and propacetamol had hypoxemia versus placebo (2.8% v. 13.2%, p < 0.05), and the mean number of hypoxemic events was significantly smaller for parecoxib (0.12), propacetamol (0.06) and parecoxib plus propacetamol (0.03) versus placebo (0.36; all p < 0.05).","[{'ForeName': 'Margaret Noyes', 'Initials': 'MN', 'LastName': 'Essex', 'Affiliation': 'From Pfizer Inc., New York, NY (Essex, Pan, Cheung); the Department of Anesthesiology, University of Brussels, Brussels, Belgium (Camu); the Department of Anaesthesiology, Balgrist University Hospital, Zurich, Switzerland (Borgeat); and Pfizer Inc., Mexico City, Mexico (Salomon).'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Camu', 'Affiliation': 'From Pfizer Inc., New York, NY (Essex, Pan, Cheung); the Department of Anesthesiology, University of Brussels, Brussels, Belgium (Camu); the Department of Anaesthesiology, Balgrist University Hospital, Zurich, Switzerland (Borgeat); and Pfizer Inc., Mexico City, Mexico (Salomon).'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Borgeat', 'Affiliation': 'From Pfizer Inc., New York, NY (Essex, Pan, Cheung); the Department of Anesthesiology, University of Brussels, Brussels, Belgium (Camu); the Department of Anaesthesiology, Balgrist University Hospital, Zurich, Switzerland (Borgeat); and Pfizer Inc., Mexico City, Mexico (Salomon).'}, {'ForeName': 'P Arline', 'Initials': 'PA', 'LastName': 'Salomon', 'Affiliation': 'From Pfizer Inc., New York, NY (Essex, Pan, Cheung); the Department of Anesthesiology, University of Brussels, Brussels, Belgium (Camu); the Department of Anaesthesiology, Balgrist University Hospital, Zurich, Switzerland (Borgeat); and Pfizer Inc., Mexico City, Mexico (Salomon).'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Pan', 'Affiliation': 'From Pfizer Inc., New York, NY (Essex, Pan, Cheung); the Department of Anesthesiology, University of Brussels, Brussels, Belgium (Camu); the Department of Anaesthesiology, Balgrist University Hospital, Zurich, Switzerland (Borgeat); and Pfizer Inc., Mexico City, Mexico (Salomon).'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Cheung', 'Affiliation': 'From Pfizer Inc., New York, NY (Essex, Pan, Cheung); the Department of Anesthesiology, University of Brussels, Brussels, Belgium (Camu); the Department of Anaesthesiology, Balgrist University Hospital, Zurich, Switzerland (Borgeat); and Pfizer Inc., Mexico City, Mexico (Salomon).'}]",Canadian journal of surgery. Journal canadien de chirurgie,['10.1503/cjs.010519']
71,32386720,"Raltegravir versus efavirenz in antiretroviral-naive pregnant women living with HIV (NICHD P1081): an open-label, randomised, controlled, phase 4 trial.","BACKGROUND


Although antiretroviral regimens containing integrase inhibitors rapidly suppress HIV viral load in non-pregnant adults, few published data from randomised controlled trials have compared the safety and efficacy of any integrase inhibitor to efavirenz when initiated during pregnancy. We compared safety and efficacy of antiretroviral therapy with either raltegravir or efavirenz in late pregnancy.
METHODS


An open-label, randomised controlled trial was done at 19 hospitals and clinics in Argentina, Brazil, South Africa, Tanzania, Thailand, and the USA. Antiretroviral-naive pregnant women (20-<37 weeks gestation) living with HIV were assigned to antiretroviral regimens containing either raltegravir (400 mg twice daily) or efavirenz (600 mg each night) plus lamivudine 150 mg and zidovudine 300 mg twice daily (or approved alternative backbone regimen), using a web-based, permuted-block randomisation stratified by gestational age and backbone regimen. The primary efficacy outcome was plasma HIV viral load below 200 copies per mL at (or near) delivery. The primary efficacy analysis included all women with a viral load measurement at (or near) delivery who had viral load of at least 200 copies per mL before treatment and no genotypic resistance to any study drugs; secondary analyses eliminated these exclusion criteria. The primary safety analyses included all women who received study drug, and their infants. This trial is registered with Clinicaltrials.gov, number NCT01618305.
FINDINGS


From Sep 5, 2013, to Dec 11, 2018, 408 women were enrolled (206 raltegravir, 202 efavirenz) and 394 delivered on-study (200 raltegravir, 194 efavirenz); 307 were included in the primary efficacy analysis (153 raltegravir, 154 efavirenz). 144 (94%) women in the raltegravir group and 129 (84%) in the efavirenz group met the primary efficacy outcome (absolute difference 10%, 95% CI 3-18; p=0·0015); the difference primarily occurred among women enrolling later in pregnancy (interaction p=0·040). Frequencies of severe or life-threatening adverse events were similar among mothers (30% in each group; 61 raltegravir, 59 efavirenz) and infants (25% in each group; 50 raltegravir, 48 efavirenz), with no treatment-related deaths.
INTERPRETATION


Our findings support major guidelines. The integrase inhibitor dolutegravir is currently a preferred regimen for the prevention of perinatal HIV transmission with raltegravir recommended as a preferred or alternative integrase inhibitor for pregnant women living with HIV.
FUNDING


Eunice Kennedy Shriver National Institute of Child Health and Human Development and National Institute of Allergy and Infectious Diseases.",2020,"Frequencies of severe or life-threatening adverse events were similar among mothers (30% in each group; 61 raltegravir, 59 efavirenz) and infants (25% in each group; 50 raltegravir, 48 efavirenz), with no treatment-related deaths.
","['non-pregnant adults', 'women with a viral load measurement at (or near) delivery who had viral load of at least 200 copies per mL before treatment and no genotypic resistance to any study drugs; secondary analyses eliminated these exclusion criteria', '19 hospitals and clinics in Argentina, Brazil, South Africa, Tanzania, Thailand, and the USA', 'Antiretroviral-naive pregnant women (20-<37 weeks gestation) living with HIV', 'antiretroviral-naive pregnant women living with HIV (NICHD P1081', 'From Sep 5, 2013, to Dec 11, 2018, 408 women were enrolled (206 raltegravir, 202 efavirenz) and 394 delivered on-study (200 raltegravir, 194 efavirenz); 307 were included in the primary efficacy analysis (153 raltegravir, 154 efavirenz', 'pregnant women living with HIV', '144']","['lamivudine 150 mg and zidovudine', 'raltegravir', 'raltegravir or efavirenz', 'efavirenz', 'Raltegravir versus efavirenz']","['Frequencies of severe or life-threatening adverse events', 'safety and efficacy', 'plasma HIV viral load below 200 copies per mL at (or near) delivery']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1261478', 'cui_str': 'Viral load'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1513896', 'cui_str': 'National Institute of Child Health and Human Development'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C0987069', 'cui_str': 'Lamivudine 150 MG'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",408.0,0.357245,"Frequencies of severe or life-threatening adverse events were similar among mothers (30% in each group; 61 raltegravir, 59 efavirenz) and infants (25% in each group; 50 raltegravir, 48 efavirenz), with no treatment-related deaths.
","[{'ForeName': 'Esaú C', 'Initials': 'EC', 'LastName': 'João', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil. Electronic address: esaujoao@gmail.com.'}, {'ForeName': 'R Leavitt', 'Initials': 'RL', 'LastName': 'Morrison', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Shapiro', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'Maternal and Pediatric Infectious Diseases Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Maria Isabel S', 'Initials': 'MIS', 'LastName': 'Gouvèa', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil; Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'de Lourdes B Teixeira', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil; Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Trevon L', 'Initials': 'TL', 'LastName': 'Fuller', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.'}, {'ForeName': 'Blandina T', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Ngocho', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Boniface N', 'Initials': 'BN', 'LastName': 'Njau', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Avy', 'Initials': 'A', 'LastName': 'Violari', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johanesburg, South Africa.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Mathiba', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johanesburg, South Africa.'}, {'ForeName': 'Zaakirah', 'Initials': 'Z', 'LastName': 'Essack', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johanesburg, South Africa.'}, {'ForeName': 'Jose Henrique S', 'Initials': 'JHS', 'LastName': 'Pilotto', 'Affiliation': 'Hospital Geral de Nova Iguaçu, Nova Iguaçu, Brazil.'}, {'ForeName': 'Luis Felipe', 'Initials': 'LF', 'LastName': 'Moreira', 'Affiliation': 'Hospital Geral de Nova Iguaçu, Nova Iguaçu, Brazil.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Rolon', 'Affiliation': 'Fundacion Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cahn', 'Affiliation': 'Fundacion Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Sinart', 'Initials': 'S', 'LastName': 'Prommas', 'Affiliation': 'Bhumibol Adulyadej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'PHPT/IRD 174, Faculty of Associated Medical Sciences, Chiang Mai University and Chiangrai Prachanukroh Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Kulkanya', 'Initials': 'K', 'LastName': 'Chokephaibulkit', 'Affiliation': 'Bhumibol Adulyadej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Peerawong', 'Initials': 'P', 'LastName': 'Werarak', 'Affiliation': 'Bhumibol Adulyadej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Laimon', 'Affiliation': 'Westat, Rockville, MD, USA.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Hennessy', 'Affiliation': 'Westat, Rockville, MD, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Frenkel', 'Affiliation': ""University of Washington and Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Anthony', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Brookie M', 'Initials': 'BM', 'LastName': 'Best', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Siberry', 'Affiliation': 'US Agency for International Development, Washington, DC, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mirochnick', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30038-2']
72,32386721,"Dolutegravir versus efavirenz in women starting HIV therapy in late pregnancy (DolPHIN-2): an open-label, randomised controlled trial.","BACKGROUND


Late initiation of HIV antiretroviral therapy (ART) in pregnancy is associated with not achieving viral suppression before giving birth and increased mother-to-child transmission of HIV. We aimed to investigate virological suppression before giving birth with dolutegravir compared with efavirenz, when initiated during the third trimester.
METHODS


In this randomised, open-label trial, DolPHIN-2, we recruited pregnant women in South Africa and Uganda aged at least 18 years, with untreated but confirmed HIV infection and an estimated gestation of at least 28 weeks, initiating ART in third trimester. Participants were randomly assigned (1:1) to dolutegravir-based or efavirenz-based therapy. HIV viral load was measured 7 days and 28 days after antiretroviral initiation, at 36 weeks' gestation, and at the post-partum visit (0-14 days post partum). The primary efficacy outcome was a viral load of less than 50 copies per mL at the first post-partum visit, and the primary safety outcome was the occurrence of drug-related adverse events in mothers and infants until the post-partum visit. Longer-term follow-up of mothers and infants continues. This study is registered with ClinicalTrials.gov, NCT03249181.
FINDINGS


Between Jan 23, and Aug 15, 2018, we randomly assigned 268 mothers to dolutegravir (135) or efavirenz (133). All mothers and their infants were included in the safety analysis, and 250 mothers (125 in the dolutegravir group, 125 in the efavirenz group) and their infants in efficacy analyses, by intention-to-treat analyses. The median duration of maternal therapy at birth was 55 days (IQR 33-77). 89 (74%) of 120 in the dolutegravir group had viral loads less than 50 copies per mL, compared with 50 (43%) of 117 in the efavirenz group (risk ratio 1·64, 95% CI 1·31-2·06). 30 (22%) of 137 mothers in the dolutegravir group reported serious adverse events compared with 14 (11%) of 131 in the efavirenz group (p=0·013), particularly surrounding pregnancy and puerperium. We found no differences in births less than 37 weeks and less than 34 weeks gestation (16·4% vs 3·3%, across both groups). Three stillbirths in the dolutegravir group and one in the efavirenz group were considered unrelated to treatment. Three infant HIV infections were detected, all in the dolutegravir group, and were considered likely to be in-utero transmissions.
INTERPRETATION


Our data support the revision to WHO guidelines recommending the transition to dolutegravir in first-line ART for all adults, regardless of pregnancy or child-bearing potential.
FUNDING


Unitaid.",2020,"89 (74%) of 120 in the dolutegravir group had viral loads less than 50 copies per mL, compared with 50 (43%) of 117 in the efavirenz group (risk ratio 1·64, 95% CI 1·31-2·06).","['Between Jan 23, and Aug 15, 2018, we randomly assigned 268 mothers to dolutegravir (135) or', 'All mothers and their infants were included in the safety analysis, and 250 mothers (125 in the dolutegravir group, 125 in the efavirenz group) and their infants in efficacy analyses, by intention-to-treat analyses', 'women starting HIV therapy in late pregnancy (DolPHIN-2', 'recruited pregnant women in South Africa and Uganda aged at least 18 years, with untreated but confirmed HIV infection and an estimated gestation of at least 28 weeks, initiating ART in third trimester']","['efavirenz', 'Dolutegravir versus efavirenz', 'dolutegravir-based or efavirenz-based therapy', 'HIV antiretroviral therapy (ART']","['virological suppression', 'viral loads', 'occurrence of drug-related adverse events', 'viral load of less than 50 copies per mL at the first post-partum visit', 'serious adverse events', 'HIV viral load', 'median duration of maternal therapy']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0013005', 'cui_str': 'Dolphin'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",268.0,0.259954,"89 (74%) of 120 in the dolutegravir group had viral loads less than 50 copies per mL, compared with 50 (43%) of 117 in the efavirenz group (risk ratio 1·64, 95% CI 1·31-2·06).","[{'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kintu', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Thokozile R', 'Initials': 'TR', 'LastName': 'Malaba', 'Affiliation': 'Division of Epidemiology and Biostatistics, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jesca', 'Initials': 'J', 'LastName': 'Nakibuka', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Papamichael', 'Affiliation': 'Tropical Clinical Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Colbers', 'Affiliation': 'Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Byrne', 'Affiliation': 'Tropical Clinical Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Seden', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Eva Maria', 'Initials': 'EM', 'LastName': 'Hodel', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Tropical Clinical Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Adelline', 'Initials': 'A', 'LastName': 'Twimukye', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Josaphat', 'Initials': 'J', 'LastName': 'Byamugisha', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda; Department of Gynaecology and Obstetrics School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Reynolds', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK; Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Watson', 'Affiliation': 'Tropical Clinical Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burger', 'Affiliation': 'Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Tropical Clinical Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Waitt', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda; Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK; Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Taegtmeyer', 'Affiliation': 'International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Orrell', 'Affiliation': 'School of Public Health & Family Medicine, and Desmond Tutu HIV Centre, Department of Medicine, Institute of Infectious Diseases & Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Lamorde', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology and Biostatistics, University of Cape Town, Cape Town, South Africa; Centre for Infectious Diseases Epidemiology and Research, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Saye', 'Initials': 'S', 'LastName': 'Khoo', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK; Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK. Electronic address: khoo@liverpool.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30050-3']
73,32332634,Clinical study for external washing by traditional Chinese medicine in the treatment of multiple infectious wounds of diabetic foot: Study protocol clinical trial (SPIRIT compliant).,"BACKGROUND


Diabetic foot (DF) is among the most serious complications of type 2 diabetes. DF infection (DFI) is a key factor in the deterioration and development of DF, so controlling infection plays an important role in the treatment of the disease. Traditional Chinese medicine foot bath has been widely used in China as a complementary and alternative therapy to improve circulation and infection control of DF. However, the existing evidence shows that its efficacy and safety are still insufficient. We report a study protocol about a multicenter, double-blind, randomized, placebo controlled trial which aims to make well-designed clinical trials to evaluate the efficacy and safety of herbal medicine foot bath decoction (FBD) and explore the mechanism of external washing of Chinese herbs in DFI.
METHODS


This study is a multicenter, double-blind, randomized, placebo controlled clinical trial in which 60 eligible participants were randomly divided into an experimental group and control group at a 1:2 ratio. Both groups received the same basic treatment for DF disease, the experimental group used FBD and ordinary dressing changes, while half of the patients in the control group received placebo and ordinary dressings, and the other half received placebo and silver ion dressings. Patients in both groups will be evaluated weekly for efficacy during the intervention. The primary efficacy indicators include the types of wound pathogens, interleukin 6 and tumor necrosis factor α. Secondary efficacy indicators included blood glucose, blood lipids, wound area, lower extremity blood vessel diameter, blood flow speed, walking speed, walking distance, and traditional Chinese medicine syndrome scores. We will also conduct a safety evaluation of the drug at the end of the trial.
DISCUSSION


This multicenter, double-blind, randomized, placebo clinical trial not only provides data on the efficacy and safety of FBD, but also provides a novel treatment strategy for clinicians and DF patients.",2020,"The primary efficacy indicators include the types of wound pathogens, interleukin 6 and tumor necrosis factor α. Secondary efficacy indicators included blood glucose, blood lipids, wound area, lower extremity blood vessel diameter, blood flow speed, walking speed, walking distance, and traditional Chinese medicine syndrome scores.","['multiple infectious wounds of diabetic foot', '60 eligible participants', 'clinicians and DF patients']","['external washing by traditional Chinese medicine', 'placebo and ordinary dressings, and the other half received placebo and silver ion dressings', 'placebo', 'herbal medicine foot bath decoction (FBD']","['types of wound pathogens, interleukin 6 and tumor necrosis factor α. Secondary efficacy indicators included blood glucose, blood lipids, wound area, lower extremity blood vessel diameter, blood flow speed, walking speed, walking distance, and traditional Chinese medicine syndrome scores', 'efficacy and safety of FBD']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0206172', 'cui_str': 'Diabetic foot'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}]",60.0,0.305234,"The primary efficacy indicators include the types of wound pathogens, interleukin 6 and tumor necrosis factor α. Secondary efficacy indicators included blood glucose, blood lipids, wound area, lower extremity blood vessel diameter, blood flow speed, walking speed, walking distance, and traditional Chinese medicine syndrome scores.","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Haipo', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Long', 'Affiliation': 'Neijiang Hospital of Traditional Chinese Medicine, Neijiang, Sichuan Province, P.R. China.'}, {'ForeName': 'Luguang', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Chunguang', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Gong', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu.'}]",Medicine,['10.1097/MD.0000000000019841']
74,32393158,Blending Traditional Vocational Services and Individualized Placement and Support for Formerly Incarcerated Veterans.,"OBJECTIVE


This study compared two vocational programs: the About Face Vocational Program (AFVP), a traditional group-based vocational program created for formerly incarcerated veterans, and a hybrid program combining the AFVP with principles of individual placement and support-supported employment.
METHODS


The study evaluated 111 veterans with at least one felony conviction who had a mental illness, substance use disorder, or both. Veterans were randomly assigned to either vocational condition.
RESULTS


Veterans in the hybrid condition, compared with the AFVP alone, were more likely to find employment, had higher rates of full-time employment, and earned significantly more money over the course of the study. A comparison of only participants who found employment showed higher rates of full-time employment for veterans in the hybrid condition but similarities between the two groups in other measures of employment success.
CONCLUSIONS


Blended models of vocational services for veterans with mental illness, substance use disorders, or both are effective at returning formerly incarcerated veterans to competitive employment.",2020,"RESULTS


Veterans in the hybrid condition, compared with the AFVP alone, were more likely to find employment, had higher rates of full-time employment, and earned significantly more money over the course of the study.","['Formerly Incarcerated Veterans', 'Veterans in the hybrid condition', '111 veterans with at least one felony conviction who had a mental illness, substance use disorder, or both', 'veterans with mental illness']","['Face Vocational Program (AFVP), a traditional group-based vocational program created for formerly incarcerated veterans, and a hybrid program combining the AFVP with principles of individual placement and support-supported employment', 'vocational condition', 'AFVP']",['rates of full-time employment'],"[{'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4750554', 'cui_str': 'Individual Placement and Support'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0682295', 'cui_str': 'Full-time employment'}]",111.0,0.0219773,"RESULTS


Veterans in the hybrid condition, compared with the AFVP alone, were more likely to find employment, had higher rates of full-time employment, and earned significantly more money over the course of the study.","[{'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'LePage', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'April M', 'Initials': 'AM', 'LastName': 'Crawford', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Daisha J', 'Initials': 'DJ', 'LastName': 'Cipher', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Kemol', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Avery', 'Initials': 'A', 'LastName': 'Rock', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Julie A Parish', 'Initials': 'JAP', 'LastName': 'Johnson', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Washington', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ottomanelli', 'Affiliation': 'U.S. Department of Veterans Affairs (VA) North Texas Health Care System, Dallas (LePage, Rock); Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas (LePage); Dallas VA Research Corporation, Dallas (Crawford, Parish Johnson, Washington); College of Nursing and Health Innovation, University of Texas at Arlington, Arlington (Cipher); Department of Psychology, Colorado State University, Fort Collins (Anderson); James A. Haley Veterans Hospital, and Department of Rehabilitation and Mental Health Counseling, University of South Florida, Tampa (Ottomanelli).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201900421']
75,32394601,"Re: Antenatal magnesium sulphate for the prevention of cerebral palsy in infants born preterm: a double-blind, randomised, placebo-controlled, multi-centre trial: At which gestational ages should magnesium sulphate be given to women at risk of preterm birth?",,2020,,['infants born preterm'],"['magnesium sulphate', 'placebo']",['cerebral palsy'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]",,0.793615,,"[{'ForeName': 'Mads Langager', 'Initials': 'ML', 'LastName': 'Larsen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Krebs', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospital Amager Hvidovre, Copenhagen, Denmark.'}, {'ForeName': 'Gija', 'Initials': 'G', 'LastName': 'Rackauskaite', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, University Hospital Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Christina Engel', 'Initials': 'CE', 'LastName': 'Hoei-Hansen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Gorm', 'Initials': 'G', 'LastName': 'Greisen', 'Affiliation': 'Department of Paediatrics and Adolescent Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16268']
76,32394657,[Effect of warming acupuncture on uterine blood perfusion in patients with failed high-quality freeze-thawed embryo transfer].,"OBJECTIVE


To observe the effect of warming acupuncture on uterine blood perfusion in the patients with failed high-quality freeze-thawed embryo transfer (FET) and explore its effect mechanism on the improvement of clinical pregnancy rate after re-tranfer.
METHODS


A total of 72 patients of failed high-quality FET were randomized into an observation group and a control group, 36 cases in each one. In the observation group, after the menstrual period ended, warming acupuncture started at the acupoints located on the abdomen, e.g. Qihai (CV 6), Guanyuan (CV 4), Zhongji (CV 3) and Qugu (CV 2) and those on the lumbar sacral region, e.g. Shenshu (BL 23), Mingmen (GV 4) and Yaoyangguan (GV 3), 50 min in each treatment, once daily, at the interval of 1 day after 4-day treatment. The treatment was discontinued till the patients were at the ovulatory stage. In the control group,  nuangong yunzi  capsules were taken orally and continuously after the end of menstrual period, 3 capsules each time, three times a day and stopped at the ovulatory stage. The treatment of one menstrual cycle was taken as one course and the treatment for 3 menstrual cycles was required. Before and after treatment, the uterine artery pulsation index (PI), endometrial thickness, endometrial type, uterine blood perfusion, the recovery time of sufficient uterine blood flow, the endomentrial receptivity (ER) during the implantation window period and the clinical pregnancy rate were observed in the two groups.
RESULTS


After treatment, the endometrial thickness was increased and PI decreased obviously in the two groups ( P <0.05) and PI in the observation group was lower than that in the control group ( P <0.05). After treatment, the proportion of type a and type A of endometrium was increased markedly in the two groups ( P <0.05) and the proportion in the observation group was higher than the control group ( P <0.05). After treatment, the case proportion of sufficient uterine blood flow was increased obviously in the two groups ( P <0.05) and the value in the observation group was higher than the control group [83.3% (30/36) vs 69.4% (25/36),  P <0.05]. After treatment, the proportion of ER during the implantation window period was increased remarkably in the two groups ( P <0.05) and the value in the observation group was higher than the control group [72.2% (26/36) vs 50.0% (18/36),  P <0.05]. The recovery time of sufficient uterine blood flow in the observation group was shorter than the control group ( P <0.05) and the clinical pregnancy rate was higher than the control group [47.2% (17/36) vs 33.3% (12/36),  P <0.05].
CONCLUSION


Warming acupuncture enhances uterine blood perfusion and improves uterine endometrial receptivity so that the clinical pregnancy rate is increased after re-transfer in the patients with failed high-quality freeze-thawed embryo transfer.",2020,"After treatment, the endometrial thickness was increased and PI decreased obviously in the two groups ( P <0.05) and PI in the observation group was lower than that in the control group ( P <0.05).","['A total of 72 patients of failed high-quality FET', 'patients with failed high-quality freeze-thawed embryo transfer', 'patients with failed high-quality freeze-thawed embryo transfer (FET']","['Warming acupuncture', 'warming acupuncture']","['uterine endometrial receptivity', 'clinical pregnancy rate', 'uterine blood flow', 'proportion of ER during the implantation window period', 'proportion of type a and type A of endometrium', 'endometrial thickness', 'recovery time of sufficient uterine blood flow', 'uterine artery pulsation index (PI), endometrial thickness, endometrial type, uterine blood perfusion, the recovery time of sufficient uterine blood flow, the endomentrial receptivity (ER) during the implantation window period and the clinical pregnancy rate', 'uterine blood perfusion']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]","[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0014180', 'cui_str': 'Endometrial structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",72.0,0.0210532,"After treatment, the endometrial thickness was increased and PI decreased obviously in the two groups ( P <0.05) and PI in the observation group was lower than that in the control group ( P <0.05).","[{'ForeName': 'Wen-Wu', 'Initials': 'WW', 'LastName': 'Su', 'Affiliation': 'Department of TCM, Foshan Women and Children Health Care Center, Foshan 528000, Guangdong Province, China.'}, {'ForeName': 'Ju-Sheng', 'Initials': 'JS', 'LastName': 'Tian', 'Affiliation': 'Department of Acupuncture-Moxibustion and Tuina, Third Affiliated Hospital of Guangzhou University of CM.'}, {'ForeName': 'Xiu-An', 'Initials': 'XA', 'LastName': 'Gao', 'Affiliation': 'Department of TCM, Foshan Women and Children Health Care Center, Foshan 528000, Guangdong Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190504-k0002']
77,32394658,"[Effect of acupuncture on patients with cancer-related fatigue and serum levels of CRP, IL-6, TNF-α and sTNF-R1].","OBJECTIVE


To observe the therapeutic effect of acupuncture on cancer-related fatigue (CRF) and to explore its possible mechanism.
METHODS


A total of 80 patients with CRF were randomized into an observation group and a control group, and finally 67 patients completed the trial (36 patients in the observation group, 31 patients in the control group). Patients in the control group were treated with conventional chemoradiotherapy and symptomatic treatment, while no particular anti-fatigue intervention was adopted. On the basis of treatment in the control group, acupuncture was applied at Baihui (GV 20), Guanyuan (CV 4), Qihai (CV 6), Fengchi (GB 20), Zusanli (ST 36), Sanyinjiao (SP 6) in the observation group, once a day, 5 times as one course, with 2 days interval between each course, totally 4 courses were required. Before and after treatment, scores of functional assessment of cancer therapy-fatigue (FACT-F) in Chinese and McGill quality of life questionnaire (MQOL), serum levels of C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-α(TNF-α) and soluble TNF receptor-1 (sTNF-R1) were observed in the two groups.
RESULTS


①Compared before treatment, the FACT-F score was decreased after treatment in the observation group ( P <0.05), while there was no significant difference in the control group ( P <0.05). The change of the FACT-F score in the observation group was larger than that in the control group ( P <0.05). ②In the observation group, scores of physiological and psychological dimension were decreased ( P <0.05), score of social support dimension was increased after the treatment ( P <0.05). The score changes of physiological, psychological and social support dimension in the observation group were larger than those in the control group (all  P <0.05). ③After treatment, the serum levels of IL-6, TNF-α and sTNF-R1 were decreased in the observation group ( P <0.05), while the serum levels of CPR and IL-6 were increased in the control group ( P <0.05). The serum levels of CPR, IL-6 and TNF-α in the observation were lower than those in the control group ( P <0.05).
CONCLUSION


①Acupuncture can improve the related symptoms of depression, weakness and headache in patients with CRF, strengthen their cognition of the support from society and family, and boost the confidence in curing the disease. ②Acupuncture can effectively down-regulate serum levels of the relative inflammatory factors, which may be its possible mechanism on treating CRF.",2020,"The serum levels of CPR, IL-6 and TNF-α in the observation were lower than those in the control group ( P <0.05).
","['patients with CRF', 'patients with cancer-related fatigue and serum levels of CRP, IL-6, TNF-α and sTNF-R1', '80 patients with CRF']","['acupuncture', '①Acupuncture', '②Acupuncture', 'conventional chemoradiotherapy and symptomatic treatment, while no particular anti-fatigue intervention']","['serum levels of CPR and IL-6', 'cancer-related fatigue (CRF', 'related symptoms of depression, weakness and headache', 'scores of functional assessment of cancer therapy-fatigue (FACT-F) in Chinese and McGill quality of life questionnaire (MQOL), serum levels of C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-α(TNF-α) and soluble TNF receptor-1 (sTNF-R1', 'score changes of physiological, psychological and social support dimension', 'score of social support dimension', 'scores of physiological and psychological dimension', 'serum levels of CPR, IL-6 and TNF-α in the observation', 'FACT-F score', 'serum levels of IL-6, TNF-α and sTNF-R1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",80.0,0.0266516,"The serum levels of CPR, IL-6 and TNF-α in the observation were lower than those in the control group ( P <0.05).
","[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Qing', 'Affiliation': 'Department of Acupuncture and Moxibustion, First Affiliated Hospital of Jinan University, Guangzhou 510630, Guangdong Province, China.'}, {'ForeName': 'Jian-Fu', 'Initials': 'JF', 'LastName': 'Zhao', 'Affiliation': 'Department of Oncology, First Affiliated Hospital of Jinan University, Guangzhou 510630, Guangdong Province, China.'}, {'ForeName': 'Cang-Huan', 'Initials': 'CH', 'LastName': 'Zhao', 'Affiliation': 'Department of Acupuncture and Moxibustion, First Affiliated Hospital of Jinan University, Guangzhou 510630, Guangdong Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture and Moxibustion, First Affiliated Hospital of Jinan University, Guangzhou 510630, Guangdong Province, China.'}, {'ForeName': 'Yan-Long', 'Initials': 'YL', 'LastName': 'Lin', 'Affiliation': 'Department of Acupuncture and Moxibustion, First Affiliated Hospital of Jinan University, Guangzhou 510630, Guangdong Province, China.'}, {'ForeName': 'Ke-Jie', 'Initials': 'KJ', 'LastName': 'He', 'Affiliation': 'Department of Acupuncture and Moxibustion, First Affiliated Hospital of Jinan University, Guangzhou 510630, Guangdong Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190423-k0002']
78,32394663,[Application of expertise-based pragmatic randomized controlled trial in acupuncture-moxibustion clinical research].,"According to clinical practice, the characteristics and issues of pragmatic randomized controlled trial(PRCT) and expertise-based randomized controlled trial (EBRCT) in acupuncture-moxibustion clinical research were summarized. The characteristics of expertise-based pragmatic randomized controlled trial (EB-PRCT), which is the combination of above two, and its application in acupuncture-moxibustion clinical trial were explored. PRCT emphasizes the clinical practice, the positive control of standard therapy and the the blind performance on data collection and statistics. PRCT has the advantage of flexible grouping, nevertheless, it also has shortcomings such as higher cost and lack of typical subjects. EBRCT emphasizes the participation of professional acupuncturists, so that the therapeutic effect is ensured, the compliance of subjects and the bias of manipulation are improved. Thus, the replacement scheme of acupuncturists is essential in EBRCT. Having the complementary advantages, EB-PRCT provides a superior research method for acupuncture-moxibustion clinical trial, and leads to convincing results.",2020,"Having the complementary advantages, EB-PRCT provides a superior research method for acupuncture-moxibustion clinical trial, and leads to convincing results.",[],"['acupuncture-moxibustion', 'PRCT']",[],[],"[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],2.0,0.132677,"Having the complementary advantages, EB-PRCT provides a superior research method for acupuncture-moxibustion clinical trial, and leads to convincing results.","[{'ForeName': 'Ze-Gong', 'Initials': 'ZG', 'LastName': 'Xu', 'Affiliation': 'College of Chinese Medicine, Guangzhou University of CM, Guangzhou 510006, Guangdong Province, China.'}, {'ForeName': 'Shu-Qi', 'Initials': 'SQ', 'LastName': 'Ge', 'Affiliation': 'Clinical Medical College of Acupuncture- Moxibustion and Rehabilitation, Guangzhou University of CM, Guangzhou 510006, Guangdong Province, China.'}, {'ForeName': 'Li-Ming', 'Initials': 'LM', 'LastName': 'Lu', 'Affiliation': 'Clinical Medical College of Acupuncture- Moxibustion and Rehabilitation, Guangzhou University of CM, Guangzhou 510006, Guangdong Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190514-0001']
79,32392952,[Efficacy of minimally invasive pulmonary surfactant administration in preterm infants with neonatal respiratory distress syndrome: a multicenter clinical trial].,"Objective:  To explore the feasibility and safety of minimally invasive surfactant administration (MISA) in preterm neonates with respiratory distress syndrome (NRDS).  Methods:  In this multicenter prospective randomized controlled trial, 92 preterm infants with gestation age ≤30 weeks and diagnosed with NRDS were enrolled in 8 level Ⅲ neonatal intensive care units (NICU) in Beijing-Tianjin-Hebei Region from 1(st) July 2017 to 31(st) December 2018. They were randomly assigned to minimally invasive surfactant administration (MISA) group or endotracheal intubation surfactant administration (EISA) group according to random number generated by computer. Infants in both groups received calf pulmonary surfactant preparation at a dose of 70-100 mg/kg. The data of demography, perinatal situation, medication administration, complications, clinical outcomes in the two groups were compared with Chi-square test, Student's  t -test, Mann-Whitney  U  test or Fisher's exact test.  Results:  Among the 92 preterm infants, 53 were males, 39 were females; 47 were in the MISA group (25 males), and 45 were in the EISA group (28 males). The gestational age and birth weight were (29.5±1.2) weeks and (1 271±242) g in all patients, (29.5±1.4) weeks and (1 285±256) g in the MISA group, and (29.6±0.9) weeks and (1 255±227) g in the EISA group. The duration of surfactant infusion and the length of whole procedure in the MISA group were significantly longer than that in the EISA group (60 (18, 270) s  vs.  50 (30, 60) s,  Z= 3.009,  P= 0.003; 90 (60, 300) s  vs.  60 (44, 270) s,  Z= 3.365,  P= 0.001). For the outcomes, the incidence of hemodynamically significant patent ductus arteriosus (hsPDA) and bronchopulmonary dysplasia (BPD) were lower in the MISA group than in the EISA group (36% (17/47)  vs.  67% (30/45), χ(2)=8.556,  P= 0.003; 26% (12/47)  vs.  47% (21/45), χ(2)=4.464,  P= 0.035).  Conclusions:  Minimally invasive surfactant administration is applicable in preterm infants ≤30 weeks gestational age with NRDS. Although the length of whole procedure is longer than route endotracheal administration, the benefit of decreasing the incidences of hsPDA and BPD outweighs this demerit.",2020,"The duration of surfactant infusion and the length of whole procedure in the MISA group were significantly longer than that in the EISA group (60 (18, 270) s  vs.  50 (30, 60) s,  Z= 3.009,  P= 0.003; 90 (60, 300) s  vs.  60 (44, 270) s,  Z= 3.365,  P= 0.001).","['92 preterm infants with gestation age ≤30 weeks and diagnosed with NRDS were enrolled in 8 level Ⅲ neonatal intensive care units (NICU) in Beijing-Tianjin-Hebei Region from 1(st', 'preterm infants ≤30 weeks gestational age with NRDS', 'July 2017 to 31(st) December 2018', '92 preterm infants, 53 were males, 39 were females; 47 were in the MISA group (25 males), and 45 were in the EISA group (28 males', 'preterm neonates with respiratory distress syndrome (NRDS', 'preterm infants with neonatal respiratory distress syndrome']","['Minimally invasive surfactant administration', 'minimally invasive surfactant administration (MISA', 'EISA', 'calf pulmonary surfactant preparation', 'minimally invasive pulmonary surfactant administration', 'minimally invasive surfactant administration (MISA) group or endotracheal intubation surfactant administration (EISA']","['incidence of hemodynamically significant patent ductus arteriosus (hsPDA) and bronchopulmonary dysplasia (BPD', 'duration of surfactant infusion and the length of whole procedure', 'gestational age and birth weight', 'feasibility and safety']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",92.0,0.148513,"The duration of surfactant infusion and the length of whole procedure in the MISA group were significantly longer than that in the EISA group (60 (18, 270) s  vs.  50 (30, 60) s,  Z= 3.009,  P= 0.003; 90 (60, 300) s  vs.  60 (44, 270) s,  Z= 3.365,  P= 0.001).","[{'ForeName': 'H Q', 'Initials': 'HQ', 'LastName': 'Liu', 'Affiliation': 'Department of Pediatrics, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'X M', 'Initials': 'XM', 'LastName': 'Tong', 'Affiliation': 'Department of Pediatrics, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'T Y', 'Initials': 'TY', 'LastName': 'Han', 'Affiliation': 'Department of Pediatrics, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, Peking University Third Hospital, Beijing 100191, China.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': ""Department of Neonatology, Fifth Medical Center, General Hospital of the Chinese People's Liberation Army, Beijing 100039, China.""}, {'ForeName': 'X F', 'Initials': 'XF', 'LastName': 'Zhang', 'Affiliation': ""Department of Neonatology, Fifth Medical Center, General Hospital of the Chinese People's Liberation Army, Beijing 100039, China.""}, {'ForeName': 'X J', 'Initials': 'XJ', 'LastName': 'Liu', 'Affiliation': 'Department of Neonatology, Central Hospital of China National Petroleum Corporation, Langfang 065000, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Central Hospital of China National Petroleum Corporation, Langfang 065000, China.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Central Hospital of China National Petroleum Corporation, Langfang 065000, China.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Department of Neonatology, 980 Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army, Shijiazhuang 050082, China.""}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Bao', 'Affiliation': ""Department of Neonatology, 980 Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army, Shijiazhuang 050082, China.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'Department of Neonatology, Tianjin Central Hospital of Obstetrics and Gynecology, Tianjin 300100, China.'}, {'ForeName': 'X Y', 'Initials': 'XY', 'LastName': 'Tian', 'Affiliation': 'Department of Neonatology, Tianjin Central Hospital of Obstetrics and Gynecology, Tianjin 300100, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Gao', 'Affiliation': 'Department of Neonatology, Tianjin Central Hospital of Obstetrics and Gynecology, Tianjin 300100, China.'}, {'ForeName': 'W X', 'Initials': 'WX', 'LastName': 'Zhang', 'Affiliation': 'Department of Neonatology, Tianjin Central Hospital of Obstetrics and Gynecology, Tianjin 300100, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Duan', 'Affiliation': 'Department of Neonatology, Second Hospital of Tianjin Medical University, Tianjin 300211, China.'}, {'ForeName': 'F F', 'Initials': 'FF', 'LastName': 'Sun', 'Affiliation': 'Department of Neonatology, Second Hospital of Tianjin Medical University, Tianjin 300211, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""Department of Neonatology, Xingtai People's Hospital, Xingtai 054001, China.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Neonatology, Xingtai People's Hospital, Xingtai 054001, China.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Department of Neonatology, Cangzhou Central Hospital, Cangzhou 061001, China.'}, {'ForeName': 'W L', 'Initials': 'WL', 'LastName': 'Liu', 'Affiliation': 'Department of Neonatology, Cangzhou Central Hospital, Cangzhou 061001, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Department of Neonatology, Cangzhou Central Hospital, Cangzhou 061001, China.'}]",Zhonghua er ke za zhi = Chinese journal of pediatrics,['10.3760/cma.j.cn112140-20191018-00658']
80,32394651,[Acupuncture at acupoints along the meridians for primary insomnia: a multi-center randomized controlled trial].,"OBJECTIVE


To compare the clinical effect differences among different acupoint selection methods for primary insomnia.
METHODS


A total of 333 patients with primary insomnia were recruited from 3 study centers and randomly divided into a group A (111 cases, 7 cases dropped off), a group B (111 cases, 5 cases dropped off) and a group C (111 cases, 2 cases dropped off). The patients in the group A were treated with acupuncture at Shenmen (HT 7) and Baihui (GV 20), the patients in the group B were treated with acupuncture at Sanyinjiao (SP 6) and Baihui (GV 20), and the patients in the group C were treated with acupuncture at non-acupoint and Baihui (GV 20). All the treatment was given once a day, 30 min each time; 5 treatments were taken as a course and 5 courses of treatment were given. The Pittsburgh sleep quality index (PSQI) and Athens insomnia scale (AIS) scores were evaluated before and after treatment as well as 4 weeks after treatment. The encephalofluctuograph technology (ET) was observed before and after treatment.
RESULTS


Compared before treatment, the PSQI scores after treatment and at follow-up were significantly decreased in three groups ( P <0.01), and the decrease in the group A and the group B was greater than that in the group C ( P <0.01). Compared before treatment, the AIS scores after treatment and at follow-up was significantly decreased in three groups ( P <0.01), and the decrease in the group A was greater than that in the group C ( P <0.05). The interclass and between-groups ET before and after treatment had no significant difference ( P >0.05).
CONCLUSION


The acupuncture at acupoints along the meridians could improve the sleep quality in patients with primary insomnia, and the therapeutic effect of acupoint along the meridians is better than that of non-acupoint.",2020,"The interclass and between-groups ET before and after treatment had no significant difference ( P >0.05).
","['patients with primary insomnia', '333 patients with primary insomnia', 'primary insomnia']","['acupuncture at Sanyinjiao (SP 6) and Baihui (GV 20', 'acupuncture', 'Acupuncture', 'acupuncture at non-acupoint and Baihui (GV 20']","['AIS scores', 'Pittsburgh sleep quality index (PSQI) and Athens insomnia scale (AIS) scores', 'PSQI scores', 'sleep quality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}, {'cui': 'C4517724', 'cui_str': '333'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0626533', 'cui_str': 'SP 6'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",333.0,0.0267501,"The interclass and between-groups ET before and after treatment had no significant difference ( P >0.05).
","[{'ForeName': 'Xue-Fen', 'Initials': 'XF', 'LastName': 'Wu', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Xue-Na', 'Initials': 'XN', 'LastName': 'Zheng', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Chen', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Xin-Ran', 'Initials': 'XR', 'LastName': 'Wei', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hunan University of CM, Changsha 410208, China.'}, {'ForeName': 'Zeng-Hui', 'Initials': 'ZH', 'LastName': 'Yue', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Hunan University of CM, Changsha 410208, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190430-k0001']
81,32394652,[Therapeutic effect on post-stroke spastic paralysis of upper extremity treated with combination of kinematic-acupuncture therapy and rehabilitation training].,"OBJECTIVE


To compare the clinical therapeutic effect on post-stroke spastic paralysis of the upper extremity between the combination of kinematic-acupuncture therapy and rehabilitation training and the combined treatment of the conventional acupuncture with rehabilitation training.
METHODS


A total of 60 patients of post-stroke spastic paralysis of the upper extremity at the non-acute stage were randomized into an observation group (30 cases) and a control group (30 cases, 1 case dropped off). On the base of the routine western medication and rehabilitation treatment, the kinematic-acupuncture therapy was added in the observation group and the conventional acupuncture was used in the control group. Baihui (GV 20), Dazhui (GV 14), Jiaji (EX-B 2) from T 1  to T 8 , Tianzong (SI 11), Jianzhen (SI 9), Jianyu (LI 15) and Quyuan (SI 13) were selected in both groups. The treatment was given once daily and the treatment for 14 days was as one course. The one course of treatment was required in this research. Separately, before treatment and in 7 and 14 days of treatment, the score of simplified Fugl-Meyer scale of the upper extremity (FMA-UE), the grade of the modified Ashworth scale (MAS) and the score of the modified Barthel index scale (MBI) were compared between the two groups.
RESULTS


Compared before treatment, in 7 and 14 days of treatment, FMA-UE score was increased obviously in either group ( P <0.01). In 14 days of treatment, FMA-UE score in the observation group was higher than that in the control group ( P <0.05). In 7 and 14 days of treatment, MAS grades of shoulder joint, elbow joint, wrist joint and metacarpophalangeal joint were all improved markedly in the two groups ( P <0.05). Compared with the grades in 7 days of treatment, MAS grades of elbow joint and metacarpophalangeal joint were improved markedly in 14 days of treatment in the two groups ( P <0.05). Compared with the control group, MAS grades of elbow joint and metacarpophalangeal joint were improved more markedly in the observation group in 14 days of treatment ( P <0.05). Compared with the score before treatment, MBI score was increased in 7 and 14 days of treatment respectively in the observation group ( P <0.05,  P <0.01). In 14 days of treatment, MBI score was increased in the control group ( P <0.01).
CONCLUSION


For the patients with post-stroke spastic paralysis of the upper extremity at the non-acute stage, the combined treatment with kinematic-acupuncture therapy and rehabilitation training obviously improves the motor function of the upper extremity and the muscle tone of elbow joint and metacarpophalangeal joint. The therapeutic effect of this combination is better than that of the combined treatment of the conventional acupuncture with rehabilitation training. Additionally, this combined therapy improves the ability of daily life activity.",2020,"Compared with the control group, MAS grades of elbow joint and metacarpophalangeal joint were improved more markedly in the observation group in 14 days of treatment ( P <0.05).",['60 patients of post-stroke spastic paralysis of the upper extremity at the non-acute stage'],"['conventional acupuncture with rehabilitation training', 'kinematic-acupuncture therapy and rehabilitation training']","['MAS grades of elbow joint and metacarpophalangeal joint', 'MBI score', 'score of simplified Fugl-Meyer scale of the upper extremity (FMA-UE), the grade of the modified Ashworth scale (MAS) and the score of the modified Barthel index scale (MBI', 'motor function of the upper extremity and the muscle tone of elbow joint and metacarpophalangeal joint', 'MAS grades of shoulder joint, elbow joint, wrist joint and metacarpophalangeal joint', 'FMA-UE score', 'ability of daily life activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0085621', 'cui_str': 'Spastic paralysis'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0013770', 'cui_str': 'Elbow joint structure'}, {'cui': 'C0025525', 'cui_str': 'Metacarpophalangeal joint structure'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C1322271', 'cui_str': 'Wrist joint structure'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",60.0,0.0281837,"Compared with the control group, MAS grades of elbow joint and metacarpophalangeal joint were improved more markedly in the observation group in 14 days of treatment ( P <0.05).","[{'ForeName': 'Xin-Yun', 'Initials': 'XY', 'LastName': 'Huang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to Shanghai University of TCM, Shanghai 200437, China.'}, {'ForeName': 'Qiu-Fang', 'Initials': 'QF', 'LastName': 'Xia', 'Affiliation': 'Department of Chinese Medicine Rehabilitation, Shanghai First Rehabilitation Hospital.'}, {'ForeName': 'Hui-Wen', 'Initials': 'HW', 'LastName': 'Zhu', 'Affiliation': 'Department of Chinese Medicine Rehabilitation, Shanghai First Rehabilitation Hospital.'}, {'ForeName': 'Shu-Yun', 'Initials': 'SY', 'LastName': 'Jiang', 'Affiliation': 'Institute of Tuina, Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to Shanghai University of TCM.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Institute of Tuina, Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to Shanghai University of TCM.'}, {'ForeName': 'Run-Jia', 'Initials': 'RJ', 'LastName': 'Zhu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to Shanghai University of TCM, Shanghai 200437, China.'}, {'ForeName': 'Xiao-Tong', 'Initials': 'XT', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to Shanghai University of TCM, Shanghai 200437, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, Yueyang Integrated Chinese and Western Medicine Hospital Affiliated to Shanghai University of TCM, Shanghai 200437, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190505-0006']
82,32395901,A randomised controlled trial comparing deep neuromuscular blockade reversed with sugammadex with moderate neuromuscular block reversed with neostigmine.,"Deep neuromuscular block aims to improve operative conditions during laparoscopic surgery with a lower intra-abdominal pressure. Studies are conflicting on whether meaningful improvements in quality of recovery occur beyond emergence, and whether lower intra-abdominal pressure is achieved. In this pragmatic randomised trial with 1:1 allocation, adults undergoing elective laparoscopic surgery were allocated to moderate neuromuscular block reversed with neostigmine, or deep neuromuscular block reversed with sugammadex. Allocation was revealed to the anaesthetist only. Primary outcome was cognitive recovery of the Postoperative Quality of Recovery Scale, 7 days after surgery. Secondary outcomes included recovery in other domains of the Postoperative Quality of Recovery Scale at 15 min and 40 min; days 1, 3, 7, 14; and 1 and 3 months after surgery. Chi-square test was used for the primary outcome, and generalised linear mixed model for recovery over time between groups. Of 350 participants randomised, 140 (deep) and 144 (moderate) were analysed for the primary outcome. There was no difference in the Postoperative Quality of Recovery Scale cognitive domain at day 7 (deep 92.9% vs. moderate 91.8%, OR 1.164; 95%CI 0.486-2.788, p = 0.826), or at any other time-point. No significant difference was observed for physiological, emotive, activities of daily living, nociception, or overall recovery. Length of stay in the recovery area (mean (SD) deep 108 (58) vs. moderate 109 (57) min, p = 0.78) and hospital (1.8 (1.9) vs. 2.6 (3.5) days, p = 0.019) was not different. Intra-abdominal pressure and surgical operating conditions were not different between groups. Deep neuromuscular block did not improve quality of recovery compared with moderate neuromuscular block in operative laparoscopic surgery over a 1-h duration.",2020,"No significant difference was observed for physiological, emotive, activities of daily living, nociception, or overall recovery.","['adults undergoing elective laparoscopic surgery', '350 participants randomised, 140 (deep) and 144 (moderate']","['neostigmine, or deep neuromuscular block reversed with sugammadex', 'neostigmine', 'laparoscopic surgery']","['Length of stay', 'Postoperative Quality of Recovery Scale cognitive domain', 'physiological, emotive, activities of daily living, nociception, or overall recovery', 'recovery in other domains of the Postoperative Quality of Recovery Scale', 'Intra-abdominal pressure and surgical operating conditions', 'cognitive recovery of the Postoperative Quality of Recovery Scale', 'quality of recovery']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0234194', 'cui_str': 'Nociperception'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",350.0,0.636283,"No significant difference was observed for physiological, emotive, activities of daily living, nociception, or overall recovery.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boggett', 'Affiliation': 'Department of Surgery, University of Melbourne, Vic., Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chahal', 'Affiliation': 'Department of Anaesthesia, Peri-operative and Pain Medicine, Peter MacCallum Cancer Centre, Melbourne, Vic., Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Griffiths', 'Affiliation': ""Department of Anaesthesia, Royal Women's Hospital, Melbourne, Vic., Australia.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Anaesthesia, Peri-operative and Pain Medicine, Peter MacCallum Cancer Centre, Melbourne, Vic., Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesia, Peri-operative and Pain Medicine, Peter MacCallum Cancer Centre, Melbourne, Vic., Australia.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Williams', 'Affiliation': 'Department of Surgery, University of Melbourne, Vic., Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Riedel', 'Affiliation': 'Department of Anaesthesia, Peri-operative and Pain Medicine, Peter MacCallum Cancer Centre, Melbourne, Vic., Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bowyer', 'Affiliation': 'Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Melbourne, Vic., Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Royse', 'Affiliation': 'Department of Surgery, University of Melbourne, Vic., Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Royse', 'Affiliation': 'Department of Surgery, University of Melbourne, Vic., Australia.'}]",Anaesthesia,['10.1111/anae.15094']
83,32394653,[Effect of early electroacupuncture intervention on conscious state of patients after traumatic brain injury surgery].,"OBJECTIVE


To evaluate recovering consciousness effect of electroacupuncture (EA) on patients after traumatic brain injury (TBI) surgery.
METHODS


A total of 100 patients with traumatic coma were randomly divided into an observation group and a control group, 50 cases in each group. The control group was mainly treated with awakening drugs and neurotrophic drugs; on the basis of treatment in the control group, the observation group was treated with EA at Neiguan (PC 6) and Shuigou (GV 26) with disperse-dense wave, 2 Hz/100 Hz in frequency, 0.1-5 mA in intensity. After 30 min of EA, the needles were stayed 60 min. The treatment was performed once a day for 14 consecutive days. The changes in Glasgow coma score (GCS) was observed in the two groups before treatment and after 7, 14 days of treatment; and the two groups were followed up for 3 months after treatment to evaluate the Glasgow outcome scale (GOS) and Barthel index (BI) scores.
RESULTS


After 7, 14 days of treatment, the GCS scores of the two groups were higher than those before treatment ( P <0.05), and the increase degree in the observation group was significantly larger than that in the control group ( P <0.05). At 3 months of follow-up, the GOS and BI scores of the observation group were better than those of the control group ( P <0.05).
CONCLUSION


Early electroacupuncture intervention can effectively promote the recovery of consciousness after traumatic brain injury surgery, and has a curative long-term effect.",2020,"At 3 months of follow-up, the GOS and BI scores of the observation group were better than those of the control group ( P <0.05).
","['100 patients with traumatic coma', 'patients after traumatic brain injury surgery', 'patients after traumatic brain injury (TBI) surgery']","['electroacupuncture intervention', 'EA at Neiguan (PC 6) and Shuigou (GV 26) with disperse-dense wave, 2 Hz/100', 'electroacupuncture (EA', 'awakening drugs and neurotrophic drugs']","['GOS and BI scores', 'conscious state', 'Glasgow coma score (GCS', 'GCS scores', 'Glasgow outcome scale (GOS) and Barthel index (BI) scores']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0394016', 'cui_str': 'Post-traumatic coma'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C1271007', 'cui_str': 'Glasgow coma score'}]",100.0,0.0202375,"At 3 months of follow-up, the GOS and BI scores of the observation group were better than those of the control group ( P <0.05).
","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Integrated Chinese and Western Medicine, West China Hospital of Sichuan University, Chengdu 610064, China.'}, {'ForeName': 'Xue-Ling', 'Initials': 'XL', 'LastName': 'Wang', 'Affiliation': 'Department of Integrated Chinese and Western Medicine, West China Hospital of Sichuan University, Chengdu 610064, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Zi', 'Affiliation': 'Department of Integrated Chinese and Western Medicine, West China Hospital of Sichuan University, Chengdu 610064, China.'}, {'ForeName': 'Chao-Hua', 'Initials': 'CH', 'LastName': 'Yang', 'Affiliation': 'Neurosurgery, West China Hospital of Sichuan University, Chengdu 610064, China.'}, {'ForeName': 'Hui-Ping', 'Initials': 'HP', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, First Affiliated Hospital of Southern University of Science and Technology.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Integrated Chinese and Western Medicine, West China Hospital of Sichuan University, Chengdu 610064, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190506-0005']
84,32394654,"["" SHAO 's five-needle method"" as the main treatment for allergic rhinitis and asthma syndrome: a multi-center randomized controlled trial].","OBJECTIVE


To compare the clinical effect differences between "" SHAO 's five-needle method"" and routine acupoint selection on allergic rhinitis and asthma syndrome.
METHODS


A total of 210 patients with allergic rhinitis and asthma syndrome were randomly divided into an observation group (105 cases, 4 cases dropped off) and a control group (105 cases, 4 cases dropped off). The patients in the observation group were treated with "" SHAO 's five-needling method"", and the acupoints of Feishu (BL 13), Dazhui (GV 14), Fengmen (BL 12), Yintang (GV 29), Shangyingxiang (EX-HN 8) and Hegu (LI 4), etc. were selected; the patients in the control group was treated with routine acupuncture, and the acupoints of Feishu (BL 13), Zhongfu (LU 1), Taiyuan (LU 9), Dingchuan (EX-B 1), Danzhong (CV 17), Yintang (GV 29), Fengmen (BL 12) and Zusanli (ST 36), etc. were selected. The treatment in the two groups was given once a day, 6 times a week, for 4 weeks. The score of symptoms and signs was observed before and after treatment as well as 1 month, 2 months and 3 months after treatment. The forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF) and eosinophils in peripheral blood were measured before and after treatment in the two groups. After treatment, the clinical therapeutic effect was compared between the two groups.
RESULTS


The total effective rate was 98.0% (99/101) in the observation group, which was superior to 94.1% (95/101) in the control group ( P <0.01). Compared before treatment, the total score of symptoms and signs in the two groups was significantly decreased at 1, 2, 3 and 4 weeks of treatment ( P <0.01); after treatment and at each time point of follow-up, the total score of symptoms and signs in the observation group was lower than that in the control group ( P <0.01). Compared with 4 weeks of treatment, the total score of symptoms and signs at each time point of follow-up was not statistically different in the observation group ( P >0.05), and the total score of symptoms and signs in the third month of follow-up in the control group was significantly increased ( P <0.05). After treatment, FEV1 and PEF in the two groups were increased ( P <0.01), eosinophil count in peripheral blood was decreased ( P <0.01), and the improvement in the observation group was greater than that in the control group ( P <0.01,  P <0.05).
CONCLUSION


"" SHAO 's five-needle method"" can improve the clinical symptoms and pulmonary function, reduce the count of eosinophils in peripheral blood in patients with allergic rhinitis and asthma syndrome, and the curative effect is better than routine acupuncture.",2020,"After treatment, FEV1 and PEF in the two groups were increased ( P <0.01), eosinophil count in peripheral blood was decreased ( P <0.01), and the improvement in the observation group was greater than that in the control group ( P <0.01,  P <0.05).
","['patients with allergic rhinitis and asthma syndrome', '210 patients with allergic rhinitis and asthma syndrome', 'allergic rhinitis and asthma syndrome']","['routine acupuncture, and the acupoints of Feishu (BL 13), Zhongfu (LU 1), Taiyuan (LU 9), Dingchuan (EX-B 1), Danzhong (CV 17), Yintang (GV 29), Fengmen (BL 12) and Zusanli', ' SHAO \'s five-needling method"", and the acupoints of Feishu (BL 13), Dazhui (GV 14), Fengmen (BL 12), Yintang (GV 29), Shangyingxiang (EX-HN 8) and Hegu', ' SHAO \'s five-needle method"" and routine acupoint selection']","['total effective rate', 'eosinophil count in peripheral blood', 'clinical therapeutic effect', 'total score of symptoms and signs', 'forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF) and eosinophils in peripheral blood', 'score of symptoms and signs', 'FEV1 and PEF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C2606491', 'cui_str': 'zhongfu'}, {'cui': 'C0450836', 'cui_str': 'Dingchuan'}, {'cui': 'C0450834', 'cui_str': 'Yintang'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}]",210.0,0.0211125,"After treatment, FEV1 and PEF in the two groups were increased ( P <0.01), eosinophil count in peripheral blood was decreased ( P <0.01), and the improvement in the observation group was greater than that in the control group ( P <0.01,  P <0.05).
","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Henan University of CM, Zhengzhou 450008, China; Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}, {'ForeName': 'Su-Ju', 'Initials': 'SJ', 'LastName': 'Shao', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Henan University of CM, Zhengzhou 450008, China; Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}, {'ForeName': 'Pei-Yu', 'Initials': 'PY', 'LastName': 'Wang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Henan University of CM, Zhengzhou 450008, China; Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}, {'ForeName': 'Xiao-Yong', 'Initials': 'XY', 'LastName': 'Qin', 'Affiliation': 'Department of Acupuncture and Moxibustion, Kaifeng Hospital of TCM.'}, {'ForeName': 'Qing-Bo', 'Initials': 'QB', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, First Affiliated Hospital of Henan University of CM.'}, {'ForeName': 'Xiao-Gang', 'Initials': 'XG', 'LastName': 'Zhang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Henan University of CM, Zhengzhou 450008, China; Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Henan University of CM, Zhengzhou 450008, China; Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}, {'ForeName': 'Jin-Shuang', 'Initials': 'JS', 'LastName': 'Hua', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Henan University of CM, Zhengzhou 450008, China; Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}, {'ForeName': 'Bo-Yong', 'Initials': 'BY', 'LastName': 'Shao', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Henan University of CM, Zhengzhou 450008, China; Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}, {'ForeName': 'Cong-Cong', 'Initials': 'CC', 'LastName': 'Zhang', 'Affiliation': 'College of Acupuncture-Moxibustion and Tuina, Henan University of CM, Zhengzhou 450008, China; Department of Acupuncture and Moxibustion, Third Affiliated Hospital of Henan University of CM, Zhengzhou 450008.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190412-0007']
85,32394655,[Clinical observation on gastroesophageal reflux asthma treated with  tongdu jiangni  needling technique].,"OBJECTIVE


To compare the clinical effect on gastroesophageal reflux asthma between the  tongdu jiangni  needling technique of acupuncture (acupuncture for promoting the circulation of the governor vessel and reducing the reversed  qi ) and omeprazole enteric capsules (OME).
METHODS


A total of 60 patients with gastroesophageal reflux asthma were randomized into an acupuncture group and a western medication group, 30 cases in each one. The basic treatment for anti-bronchial asthma was provided in both of the groups. Additionally, OME was prescribed for oral administration in the western medication group, twice a day, 20 mg each time, for 8 weeks. In the acupuncture group, the  tongdu jiangni  needling technique of acupuncture was added. The needles were inserted at the sites inferior to the spinous processes of T 3  to T 12 . Acupuncture was given once in the morning on Tuesday, Thursday and Saturday respectively, totally for 8 weeks. Separately, before and after treatment, the score of reflux disease diagnostic questionnaire (RDQ), the score of asthma control test (ACT) and the tenderness threshold at the sites inferior to the spinous processes of T 3  to T 12  were observed and the clinical effect was evaluated in the two groups.
RESULTS


①The remarkably effective and curative rate was 46.7% (14/30) in the acupuncture group, higher than 3.3% (1/30) in the western medication group ( P <0.01). The asthma control rate was 66.7% (20/30) in the acupuncture group, higher than 13.3% (4/30) in the western medication group ( P <0.01). ②RDQ score after treatment was lower than that before treatment in either group ( P <0.05). The decrease range of RDQ score in the acupuncture group was larger than that of the western medication group ( P <0.05). After treatment, ACT score was increased as compared with that before treatment in either group ( P <0.05) and the increase range of ACT score in the acupuncture group was larger than that of the western medication group ( P <0.05). ③The tenderness thresholds at the sites inferior to the spinous processes of T 3  to T 8  and T 10  to T 12  were all increased after treatment as compared with those before treatment in the acupuncture group separately ( P <0.05). In the western medication group, the thresholds were only increased at the sites inferior to the spinous processes of T 6 , T 7  and T 9  after treatment as compared with those before treatment separately ( P <0.05). After treatment, the tenderness thresholds at T 6  to T 8  in the acupuncture group were all higher than the western medication group ( P <0.05).
CONCLUSION


The  tongdu jiangni  needling technique of acupuncture effectively relieves the symptoms of gastroesophageal reflux asthma and improves the quality of life in the patients and its effect is better than omeprazole enteric capsules.",2020,"After treatment, ACT score was increased as compared with that before treatment in either group ( P <0.05) and the increase range of ACT score in the acupuncture group was larger than that of the western medication group ( P <0.05).",['60 patients with gastroesophageal reflux asthma'],"['acupuncture', 'tongdu jiangni  needling technique', 'OME', 'acupuncture (acupuncture', 'omeprazole enteric capsules (OME', 'Acupuncture']","['quality of life', 'range of RDQ score', 'gastroesophageal reflux asthma', 'symptoms of gastroesophageal reflux asthma', 'score of reflux disease diagnostic questionnaire (RDQ), the score of asthma control test (ACT) and the tenderness threshold', 'increase range of ACT score', 'effective and curative rate', 'tenderness thresholds', '②RDQ score', 'asthma control rate', 'ACT score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0029883', 'cui_str': 'Middle ear effusion'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",60.0,0.0259268,"After treatment, ACT score was increased as compared with that before treatment in either group ( P <0.05) and the increase range of ACT score in the acupuncture group was larger than that of the western medication group ( P <0.05).","[{'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'School of Acupuncture- Moxibustion and Tuina, Beijing University of CM, Beijing 100029, China.'}, {'ForeName': 'Xing-Hua', 'Initials': 'XH', 'LastName': 'Bai', 'Affiliation': 'School of Acupuncture- Moxibustion and Tuina, Beijing University of CM, Beijing 100029, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Forth Medicine Center of the General Military Hospital.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'School of Acupuncture- Moxibustion and Tuina, Beijing University of CM, Beijing 100029, China.'}, {'ForeName': 'Wei-Bing', 'Initials': 'WB', 'LastName': 'Pan', 'Affiliation': 'School of Acupuncture- Moxibustion and Tuina, Beijing University of CM, Beijing 100029, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'School of Acupuncture- Moxibustion and Tuina, Beijing University of CM, Beijing 100029, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20191112-k0001']
86,32394656,[Post-stroke constipation treated with acupoint embedding therapy: a multi-center randomized controlled trial].,"OBJECTIVE


To verify the clinical effect of acupoint embedding therapy on post-stroke constipation.
METHODS


The multi-central randomized controlled trial was adopted. 210 patients of post-stroke constipation were divided into an acupoint embedding group (105 cases, 4 cases dropped off) and a sham-embedding group (105 cases, 6 cases dropped off). In the acupoint embedding group, the acupoint embedding therapy was used at Tianshu (ST 25), Daheng (SP 15), Xiawan (CV 10), Zhongwan (CV 12), Qihai (CV 6), Guanyuan (CV 4) and Daju (ST 27). In the sham-embedding group, the sham-embedding therapy was given, in which, the acupoint selection, needle devices and manipulation were the same as the acupoint embedding group. But, no absorbable surgical suture was used in the needle tube. The treatment was given once every two weeks and 4 treatments were required in either group. It was to compare the weekly average complete spontaneous bowel movements (CSBMs) during treatment (from the 3rd to the 8th week) between the two groups, the weekly average spontaneous bowel movements (SBMs), Bristol stool form score (BSFS), the score of the patient assessment of constipation quality of life questionnaire (PAC-QOL) and the score of defecation difficulty before and after treatment.
RESULTS


The percentage of the cases with weekly average CSBMs ≥ 3 times in the patients of the acupoint embedding group was higher markedly than the sham-embedding group [91.1% (92/101) vs 43.4% (43/99),  P <0.01]. Compared with the values before treatment, the weekly average SBMs and BSFS scores after treatment were all increased obviously in the two groups ( P <0.01), and PAC-QOL score and the score of defecation difficulty were reduced remarkably ( P <0.01). After treatment, the increase range of SBMs and BSFS scores, as well as the decrease range of PAC-QOL score and the defecation difficulty score in the acupoint embedding group were all higher than the sham-embedding group respectively ( P <0.05).
CONCLUSION


The acupoint embedding therapy remarkably increases the spontaneous bowel movements, improves in feces form and defecation difficulty and strengthens the quality of life in the patients of post-stroke constipation.",2020,"Compared with the values before treatment, the weekly average SBMs and BSFS scores after treatment were all increased obviously in the two groups ( P <0.01), and PAC-QOL score and the score of defecation difficulty were reduced remarkably ( P <0.01).",['210 patients of post-stroke constipation'],"['acupoint embedding', 'absorbable surgical suture', 'acupoint embedding therapy']","['average SBMs and BSFS scores', 'spontaneous bowel movements, improves in feces form and defecation difficulty and strengthens the quality of life', 'average spontaneous bowel movements (SBMs), Bristol stool form score (BSFS), the score of the patient assessment of constipation quality of life questionnaire (PAC-QOL) and the score of defecation difficulty', 'range of PAC-QOL score and the defecation difficulty score', 'PAC-QOL score and the score of defecation difficulty', 'increase range of SBMs and BSFS scores']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0038969', 'cui_str': 'Surgical suture'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C2732393', 'cui_str': 'Bristol stool form score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",210.0,0.0336442,"Compared with the values before treatment, the weekly average SBMs and BSFS scores after treatment were all increased obviously in the two groups ( P <0.01), and PAC-QOL score and the score of defecation difficulty were reduced remarkably ( P <0.01).","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Department of Acupuncture-Moxibustion and Tuina, Zhejiang Provincial Tongde Hospital, Hangzhou 310012, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture-Moxibustion and Tuina, Zhejiang Provincial Tongde Hospital, Hangzhou 310012, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Zhejiang Provincial Tiantai County Hospital of TCM.'}, {'ForeName': 'Chun-Mei', 'Initials': 'CM', 'LastName': 'Lu', 'Affiliation': 'Qinshan Street Community Health Service Center of Haiyan County, Zhejiang province.'}, {'ForeName': 'Jin-Feng', 'Initials': 'JF', 'LastName': 'Zhou', 'Affiliation': 'Zhejiang Provincial Haiyan County Hospital of TCM.'}, {'ForeName': 'Ping-Hua', 'Initials': 'PH', 'LastName': 'Wu', 'Affiliation': 'Gongshu District Mishixiang Street Community Health Service Center of Hangzhou City, Zhejiang Province.'}, {'ForeName': 'Li-Yuan', 'Initials': 'LY', 'LastName': 'Zheng', 'Affiliation': 'Yuhang District Wuchang Street Community Health Service Center of Hangzhou City, Zhejiang Province.'}, {'ForeName': 'Xin-Wei', 'Initials': 'XW', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture-Moxibustion and Tuina, Zhejiang Provincial Tongde Hospital, Hangzhou 310012, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190507-k0004']
87,32396474,Factors Associated with HIV Disclosure Status Among iENGAGE Cohort of New to HIV Care Patients.,"HIV disclosure is an important behavior with implications for HIV treatment and prevention but understudied among new to HIV care patients who face unique challenges adjusting to a new diagnosis. This study evaluated the factors associated with HIV disclosure status and patterns of HIV disclosure among new to HIV care patients. A cross-sectional study was conducted evaluating the iENGAGE (integrating ENGagement and Adherence Goals upon Entry) cohort. Participants were enrolled in this randomized behavioral trial between December 2013 and June 2016. The primary and secondary outcomes included HIV disclosure status (Yes/No) and patterns of disclosure (Broad, Selective and Nondisclosure), respectively. Logistic and Multinomial Logistic Regression were used to evaluate the association of participant factors with HIV disclosure and patterns of HIV disclosure, respectively. Of 371 participants, the average age was 37 ± 12 years, 79.3% were males, and 62.3% were African Americans. A majority of participants (78.4%) disclosed their HIV status at baseline, 63.1% were broad disclosers and 15.2% were selective disclosers. In multivariable regression, black race, emotional support, and unmet needs predicted any HIV and broad disclosure, whereas males, emotional support, active coping, and acceptance were associated with selective disclosure. Interventions to promote early disclosure should focus on coping strategies and unmet needs, particularly among black and male people living with HIV initiating care.",2020,"A majority of participants (78.4%) disclosed their HIV status at baseline, 63.1% were broad disclosers and 15.2% were selective disclosers.","['Of 371 participants, the average age was 37\u2009±\u200912 years, 79.3% were males, and 62.3% were African Americans', 'Participants were enrolled in this randomized behavioral trial between December 2013 and June 2016', 'black and male people living with HIV initiating care', 'HIV care patients']",[],"['HIV status', 'males, emotional support, active coping, and acceptance', 'HIV disclosure status and patterns of HIV disclosure', 'HIV disclosure status (Yes/No) and patterns of disclosure (Broad, Selective and Nondisclosure', 'HIV Disclosure Status']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0332464', 'cui_str': 'Widening'}]",,0.0384234,"A majority of participants (78.4%) disclosed their HIV status at baseline, 63.1% were broad disclosers and 15.2% were selective disclosers.","[{'ForeName': 'Riddhi A', 'Initials': 'RA', 'LastName': 'Modi', 'Affiliation': 'Department of Pathology, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Gerald L', 'Initials': 'GL', 'LastName': 'McGwin', 'Affiliation': 'Department of Epidemiology, and University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Willig', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Andrew O', 'Initials': 'AO', 'LastName': 'Westfall', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Griffin', 'Affiliation': 'Department of Epidemiology, and University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Rivet', 'Initials': 'R', 'LastName': 'Amico', 'Affiliation': 'Department of Health Behavior and Education, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Kimberly D', 'Initials': 'KD', 'LastName': 'Martin', 'Affiliation': 'Department of Epidemiology, and University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Raper', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Jeanne C', 'Initials': 'JC', 'LastName': 'Keruly', 'Affiliation': 'Department of Medicine, Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Golin', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zinski', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Napravnik', 'Affiliation': 'Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Crane', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mugavero', 'Affiliation': 'Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama.'}]",AIDS patient care and STDs,['10.1089/apc.2019.0271']
88,32334516,Does early identification of high work related stress affect pharmacological treatment of primary care patients? - analysis of Swedish pharmacy dispensing data in a randomised control study.,"BACKGROUND


The study is part of a randomised controlled trial with the overall aim to evaluate if use of the Work Stress Questionnaire (WSQ), combined with feedback at consultation, can be used by healthcare professionals in primary health care to prevent sickness absence. The specific aim of the present study was to investigate whether there were differences in pharmacy dispensing of prescription medications between the intervention group and the control group.
METHODS


The study was a randomized controlled trial. Non-sick-listed employed women and men, aged 18 to 64 years, seeking care at primary health care centres (PHCCs) were eligible participants. The intervention included early identification of work-related stress by the WSQ, general practitioner (GP) training and GP feedback at consultation. Pharmacy dispensing data from the Swedish Prescription Drug Register for a period of 12 months following the intervention was used. Primary outcomes were the number of different medications used, type of medication and number of prescribing clinics. Data was analysed using Mann Whitney U tests and chi-square tests.
RESULTS


The study population included 271 individuals (132 in the intervention group and 139 in the control group). The number of different medications used per individual did not differ significantly between the control group (median 4.0) and the intervention group (median 4.0, p-value 0.076). The proportion of individuals who collected more than 10 different medications was higher in the control group than in the intervention group (15.8% versus 4.5%, p = 0.002). In addition, the proportion of individuals filling prescriptions issued from more than three different clinics was higher in the control group than in the intervention group (17.3% versus 6.8%, p = 0.007).
CONCLUSION


Systematic use of the WSQ combined with training of GPs and feedback at consultation may affect certain aspects of pharmacological treatment in primary health care patients. In this randomised control trial, analysis of pharmacy dispensing data show that patients in the intervention group had less polypharmacy and filled prescriptions issued from a smaller number of different clinics.
TRIAL REGISTRATION


ClinicalTrials.gov. Identifier: NCT02480855. Registered 20 May 2015.",2020,"The number of different medications used per individual did not differ significantly between the control group (median 4.0) and the intervention group (median 4.0, p-value 0.076).","['Non-sick-listed employed women and men, aged 18 to 64\u2009years, seeking care at primary health care centres (PHCCs) were eligible participants', 'primary health care patients', '271 individuals (132 in the intervention group and 139 in the control group', 'primary care patients']","['WSQ combined with training of GPs and feedback at consultation', 'WSQ, general practitioner (GP) training and GP feedback at consultation', 'Work Stress Questionnaire (WSQ), combined with feedback at consultation']","['number of different medications used, type of medication and number of prescribing clinics', 'number of different medications used per individual', 'pharmacy dispensing of prescription medications', 'proportion of individuals filling prescriptions']","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0017319', 'cui_str': 'General physician'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]",,0.111827,"The number of different medications used per individual did not differ significantly between the control group (median 4.0) and the intervention group (median 4.0, p-value 0.076).","[{'ForeName': 'Pernilla J', 'Initials': 'PJ', 'LastName': 'Bjerkeli', 'Affiliation': 'School of Health and Education, University of Skövde, PO Box 408, SE-521 28, Skövde, Sweden. pernilla.bjerkeli@his.se.'}, {'ForeName': 'Ingmarie', 'Initials': 'I', 'LastName': 'Skoglund', 'Affiliation': 'Department of Primary Health Care, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, PO Box 454, SE-405 30, Gothenburg, Sweden, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Holmgren', 'Affiliation': 'Department of Health and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, PO Box 455, SE-405 30, Gothenburg, Sweden.'}]",BMC family practice,['10.1186/s12875-020-01140-x']
89,32335058,Static and Dynamic Factors Associated With Extended Depth of Focus in Monofocal Intraocular Lenses.,"PURPOSE


To analyze factors affecting depth of focus (DOF) and near vision functionality in eyes implanted with aspheric monofocal intraocular lenses (IOLs).
METHODS


This prospective study included 111 eyes of 74 patients that underwent phacoemulsification with monofocal IOL implantation. Ninety-one normal eyes were randomized to receive aberration-free (n = 30) or negative-spherical aberration (SA) IOLs (n = 61). Twenty post-hyperopic femto-LASIK eyes received aberration-free IOLs. Corneal higher-order aberrations (SA, coma, trefoil, and corneal asphericity) for a 6 mm pupil were measured by Scheimpflug tomography. Ray-tracing metrics (visual Strehl optical transfer function [VSOTF], effective range of focus [EROF], sphere shift [SS], EROF-SS), pupil size measurements at far and near, and ocular and corneal SA were obtained using ray-tracing aberrometry. Distance-corrected near visual acuity (DCNVA) and subjective defocus curves up to ±4.0 diopters were evaluated.
RESULTS


Multivariable logistic regression found corneal profile and IOL type to be determinants of extended DOF with monofocal IOLs. The aberration-free IOL group showed significantly better DCNVA and higher total SA than the negative-SA group. Post-hyperopic LASIK eyes showed significantly better DCNVA; higher negative SA, coma, and Q value (P < .05), and smaller pupil size (P = .05) than normal eyes implanted with aberration-free IOLs.
CONCLUSION


Corneal profile and type of IOL implanted were the most important factors influencing near vision functionality with aspheric monofocal IOLs. Higher positive SA in the aberration-free group potentially led to better DCNVA than the negative-SA group in normal eyes. Hyperprolate corneas had better DOF curves and DCNVA than normal corneas. NOTE: Publication of this article is sponsored by the American Ophthalmological Society.",2020,The aberration-free IOL group showed significantly better DCNVA and higher total SA than the negative-SA group.,"['eyes implanted with aspheric monofocal intraocular lenses (IOLs', 'Ninety-one normal eyes', '111 eyes of 74 patients that underwent']","['aberration-free IOLs', 'negative-spherical aberration (SA) (ZCB00) IOLs', 'phacoemulsification with monofocal IOL implantation', 'aberration-free (MX60E']","['DOF curves and DCNVA', 'Corneal higher-order aberrations (SA, coma, trefoil and corneal asphericity for 6-mm pupil', 'DCNVA, higher negative SA, coma and Q value (p<.05), and smaller pupil size', 'Ray tracing metrics [visual strehl optical transfer function (VSOTF), effective range of focus (EROF), sphere shift (SS), EROF-SS], pupil size measurements at far and near, ocular and corneal SA', 'Distance-corrected near visual acuity (DCNVA) and subjective defocus curves']","[{'cui': 'C0581278', 'cui_str': 'Ophthalmological implant'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0950061', 'cui_str': 'Trefoil'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0026205', 'cui_str': 'Persistent miosis'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0086894', 'cui_str': 'Rajiformes'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0517965', 'cui_str': 'Size of pupil'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",111.0,0.0231069,The aberration-free IOL group showed significantly better DCNVA and higher total SA than the negative-SA group.,"[{'ForeName': 'Karolinne Maia', 'Initials': 'KM', 'LastName': 'Rocha', 'Affiliation': 'Storm Eye Institute - Medical University of South Carolina, Charleston, South Carolina, USA. Electronic address: rochak@musc.edu.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Gouvea', 'Affiliation': 'Storm Eye Institute - Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'George Oral', 'Initials': 'GO', 'LastName': 'Waring', 'Affiliation': 'Waring Vision Institute, Mt. Pleasant, South Carolina, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Haddad', 'Affiliation': 'Storm Eye Institute - Medical University of South Carolina, Charleston, South Carolina, USA; Federal University of Sao Paulo - UNIFESP, São Paulo, Brazil.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.04.014']
90,32335270,"The effect of acute intragastric vs. intravenous alcohol administration on inflammation markers, blood lipids and gallbladder motility in healthy men.","Ethanol intake increases plasma concentrations of triglycerides and chronic ethanol use impairs lipid metabolism and causes chronic inflammation. The gut plays an important role in metabolic handling of nutrients, including lipids, and a leaky gut associated with alcohol intake, allowing inflammatory signals to the portal vein, has been proposed to constitute a mechanism by which ethanol induces hepatic inflammation. We compared the effects of enteral and parenteral administration of ethanol on a range of circulating inflammation markers (including soluble CD163, a marker of liver macrophage activation), lipids, cholecystokinin (CCK) and fibroblast growth factor 19 (FGF19) as well as gallbladder volume. On two separate and randomized study days, we subjected healthy men (n = 12) to double-blinded intragastric ethanol infusion (IGEI) and isoethanolemic intravenous ethanol infusion (IVEI). Blood was sampled and ultrasonographic evaluation of gallbladder volume was performed at frequent intervals for 4 h after initiation of ethanol administration on both days. Little or no effects were observed on plasma levels of inflammation markers during IGEI and IVEI, respectively. Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol decreased after ethanol administration independently of the administration form. Triglyceride and very low-density lipoprotein (VLDL) cholesterol concentrations increased more after IGEI compared to IVEI. IVEI had no effect on plasma CCK and caused an increased gallbladder volume whereas IGEI elicited a CCK response (P < 0.0001) without affecting gallbladder volume. Circulating FGF19 concentrations decreased equally in response to both ethanol administration forms. In conclusion, by evaluating a range of circulating inflammation markers during IGEI and IVEI we were not able to detect signs of systemic low-grade inflammation originating from the presence of ethanol in the gut. IVEI increased gallbladder volume whereas IGEI increased plasma CCK (with neutral effect on gallbladder volume), increased plasma VLDL cholesterol and triglyceride concentrations; indicating that the enteral route of administration may influence ethanol's effects on lipid metabolism.",2020,"Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol decreased after ethanol administration independently of the administration form.","['healthy men', 'subjected healthy men (n=12) to']","['double-blinded intragastric ethanol infusion (IGEI) and isoethanolemic intravenous ethanol infusion (IVEI', 'Ethanol intake', 'acute intragastric vs. intravenous alcohol', 'ethanol']","['Triglyceride and very low-density lipoprotein (VLDL) cholesterol concentrations', 'plasma VLDL cholesterol and triglyceride concentrations', 'inflammation markers, blood lipids and gallbladder motility', 'Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol', 'lipid metabolism', 'plasma levels of inflammation markers', 'IVEI increased gallbladder volume whereas IGEI increased plasma CCK', 'gallbladder volume', 'Circulating FGF19 concentrations', 'plasma CCK', 'circulating inflammation markers (including soluble CD163, a marker of liver macrophage activation), lipids, cholecystokinin (CCK) and fibroblast growth factor 19 (FGF19']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0016976', 'cui_str': 'Gallbladder structure'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C1431711', 'cui_str': 'FGF19 protein, human'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0251113', 'cui_str': 'CD163 antigen'}, {'cui': 'C0022801', 'cui_str': 'Kupffer cell'}]",,0.130521,"Circulating levels of total, low-density lipoprotein and high-density lipoprotein cholesterol decreased after ethanol administration independently of the administration form.","[{'ForeName': 'Amalie R', 'Initials': 'AR', 'LastName': 'Lanng', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lærke S', 'Initials': 'LS', 'LastName': 'Gasbjerg', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Natasha C', 'Initials': 'NC', 'LastName': 'Bergmann', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Gillum', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Rehfeld', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mads M', 'Initials': 'MM', 'LastName': 'Helsted', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Holger J', 'Initials': 'HJ', 'LastName': 'Møller', 'Affiliation': 'Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Grønbæk', 'Affiliation': 'Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Copenhagen, Denmark. Electronic address: filipknop@dadlnet.dk.'}]","Alcohol (Fayetteville, N.Y.)",['10.1016/j.alcohol.2020.04.006']
91,32282591,Uterine Exteriorization Compared With In Situ Repair of Hysterotomy After Cesarean Delivery: A Randomized Controlled Trial.,"OBJECTIVE


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


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


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


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


ClinicalTrials.gov, NCT02587013.",2020,"Incidence of hypotension (80% vs 50%; P<.001) and tachycardia (33% vs 17%; P=.02) was significantly higher in the exteriorization group, and more phenylephrine boluses were administered to this group (median 4 boluses [first and third quartiles 1.25-7] vs 2 [0-4]; P<.001).","['From November 2015 through July 2018, 180 patients were enrolled', '180 women undergoing elective cesarean delivery using a standardized anesthetic protocol']","['phenylephrine infusion', 'phenylephrine', 'exteriorized with in situ uterine repair', 'Uterine Exteriorization Compared With In Situ Repair of Hysterotomy', 'exteriorization (n=90) or in situ uterine repair']","['postdelivery intraoperative nausea and vomiting using a 4-point scale (0-3', 'duration of surgery, blood loss, and postoperative hemoglobin decline', 'Incidence of postdelivery intraoperative nausea and vomiting', 'tachycardia', 'postdelivery intraoperative nausea and vomiting', 'Incidence of hypotension', 'intraoperative nausea and vomiting']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0475403', 'cui_str': 'Exteriorized'}, {'cui': 'C0444498', 'cui_str': 'In situ'}, {'cui': 'C0195379', 'cui_str': 'Repair of uterus'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0185000', 'cui_str': 'Exteriorization - action'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0020711', 'cui_str': 'Incision of uterus'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",180.0,0.709089,"Incidence of hypotension (80% vs 50%; P<.001) and tachycardia (33% vs 17%; P=.02) was significantly higher in the exteriorization group, and more phenylephrine boluses were administered to this group (median 4 boluses [first and third quartiles 1.25-7] vs 2 [0-4]; P<.001).","[{'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Mireault', 'Affiliation': ""Department of Anesthesiology, Sainte-Justine Hospital, University of Montréal, and the Departments of Anesthesiology and Pain Medicine and Obstetrics and Gynecology, Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal (CEMTL), University of Montreal, Montréal, Québec, Canada.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Loubert', 'Affiliation': ''}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Drolet', 'Affiliation': ''}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Tordjman', 'Affiliation': ''}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Godin', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Richebé', 'Affiliation': ''}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Zaphiratos', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003821']
92,32282603,Double-Balloon Device for 6 Compared With 12 Hours for Cervical Ripening: A Randomized Controlled Trial.,"OBJECTIVE


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


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


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


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


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


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


Insertion-to-delivery interval is shorter after 6 compared with 12 hours for both nulliparous and parous women.","[{'ForeName': 'Inna', 'Initials': 'I', 'LastName': 'Bleicher', 'Affiliation': 'Department of Obstetrics and Gynecology, Bnai-Zion Medical Center, and the Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Dikopoltsev', 'Affiliation': ''}, {'ForeName': 'Einav', 'Initials': 'E', 'LastName': 'Kadour-Ferro', 'Affiliation': ''}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Sammour', 'Affiliation': ''}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Gonen', 'Affiliation': ''}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Sagi', 'Affiliation': ''}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Eshel', 'Affiliation': ''}, {'ForeName': 'Liraz', 'Initials': 'L', 'LastName': 'Nussam', 'Affiliation': ''}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Vitner', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003804']
93,32282608,Internal Iliac Artery Balloon Occlusion for Placenta Previa and Suspected Placenta Accreta: A Randomized Controlled Trial.,"OBJECTIVE


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


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


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


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


Chinese Clinical Trial Registry, ChiCTR-IOR-17012244.",2020,"The number of packed RBC units transfused was not significantly different between groups (5.3±5.3 in the occlusion group vs 4.7±5.4 in the control group, P=.54).","['From August 2017 to July 2018, we randomized 50 eligible women to the balloon group and 50 to the control group', 'Placenta Previa and Suspected Placenta Accreta', 'women with placenta previa and antenatally suspected placenta accreta', 'women with placenta previa and antenatally diagnosed placenta accreta']","['intraoperative balloon occlusion', 'balloon occlusion', 'Internal Iliac Artery Balloon Occlusion']","['Demographic, obstetric, and placental imaging characteristics', 'number of packed red blood cell (RBC) units transfused', 'number of packed RBC units transfused', 'Hospitalization costs and incidence of postoperative fever']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032046', 'cui_str': 'Placenta previa'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0032044', 'cui_str': 'Placenta accreta'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0226364', 'cui_str': 'Structure of internal iliac artery'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0424786', 'cui_str': 'Postoperative fever'}]",50.0,0.269494,"The number of packed RBC units transfused was not significantly different between groups (5.3±5.3 in the occlusion group vs 4.7±5.4 in the control group, P=.54).","[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Departments of Obstetrics and Gynecology, Ultrasound, Radiology, and Pathology and the Key Laboratory of Birth Defects and Related Diseases of Women and Children, Sichuan University, Ministry of Education, West China Second University Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Xinghui', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': ''}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Qu', 'Affiliation': ''}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003792']
94,32330775,Treatment with intravenous immunoglobulin increases the level of small EVs in plasma of pregnant women with recurrent pregnancy loss.,"Extracellular vesicles (EVs), which are small cell-derived compartments, take part in numerous different physiological processes. The contents of EVs reveal the cell of origin and indicates pathophysiological states in different diseases. In pregnancy disorders, changes have been reported in the composition, bioactivity and concentration of placental and non-placental EVs. The purpose of this study was to monitor the effects on EVs in patients receiving intravenous immunoglobulin (IVIG) or placebo (albumin) treatment due to recurrent pregnancy loss (RPL). In a placebo-controlled trial study of IVIG treatment, plasma collected from 39 women with RPL were investigated using the Extracellular Vesicle Array (EV Array). Plasma was sampled consecutively (from gestational week (GW) 5) and the protein phenotypes of the smaller EVs (sEVs) were analyzed for the presence of 34 markers. The levels of sEVs or changes in their levels in early pregnancy were correlated with treatment. There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo. In conclusion, the treatment with high-doses of IVIG clearly boosted the production and release of sEVs to the circulation; however, the biological role of this boost remains to be clarified in further studies.",2020,There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo.,"['pregnant women with recurrent pregnancy loss', '39 women with RPL', 'patients receiving']","['placebo', 'intravenous immunoglobulin', 'intravenous immunoglobulin (IVIG) or placebo (albumin']","['levels of sEVs or changes in their levels in early pregnancy', 'level of small EVs', 'levels of sEVs']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0156740', 'cui_str': 'Pregnancy in habitual aborter'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0001924', 'cui_str': 'albumin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0560135', 'cui_str': 'eV'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3894683', 'cui_str': 'Extracellular Vesicles'}]",39.0,0.0521941,There was statistically significant increased levels of sEVs in patients who received IVIG versus placebo.,"[{'ForeName': 'Malene Møller', 'Initials': 'MM', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark. Electronic address: maljoe@rn.dk.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Bæk', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Sloth', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Varming', 'Affiliation': 'Department of Clinical Immunology, Aalborg University Hospital, Aalborg, Denmark; Extracellular Vesicles Research Center Denmark (EVSearch.dk), Aalborg, Denmark.'}, {'ForeName': 'Ole Bjarne', 'Initials': 'OB', 'LastName': 'Christiansen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Nadja Emilie', 'Initials': 'NE', 'LastName': 'Ditlevsen', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark; School of Medicine and Health, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rajaratnam', 'Affiliation': 'Department of Obstetrics and Gynecology, Aalborg University Hospital, Aalborg, Denmark; School of Medicine and Health, Aalborg University, Aalborg, Denmark.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103128']
95,32280035,Adolescent cognitive control and mediofrontal theta oscillations are disrupted by neglect: Associations with transdiagnostic risk for psychopathology in a randomized controlled trial.,"Children that have experienced psychosocial neglect display impairments in self-monitoring and controlling their behavior (cognitive control) and are at broad, transdiagnostic risk for psychopathology. However, the neural underpinnings of such effects remain unclear. Event-related mediofrontal theta oscillations reflect a neural process supporting cognitive control that may relate to transdiagnostic psychopathology risk. Recent work demonstrates reduced mediofrontal theta in rodent models of neglect; however, similar findings have not been reported in humans. Here, 136 children reared in Romanian institutions were randomly assigned to either a high-quality foster care intervention and placed with families or remained in institutions; 72 never-institutionalized children served as a comparison group. The intervention ended at 54 months; event-related mediofrontal theta and psychopathology were assessed at 12- and 16-year follow-up assessments. Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for. Earlier placement into foster care yielded greater mediofrontal activity by age 16. Moreover, foster care placement was associated with the developmental trajectory of mediofrontal theta across the adolescent period (ages 12-16), which was, in turn, associated with greater reductions in transdiagnostic risk across this same period. These data reflect the first experimental evidence that the development of mediofrontal theta is impacted by removal from situations of neglect in humans, and further characterizes the importance of studying developmental change in mediofrontal theta during the adolescent period.",2020,"Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for.",['136 children reared in Romanian institutions'],['high-quality foster care intervention and placed with families or remained in institutions; 72 never-institutionalized children served as a comparison group'],"['Adolescent cognitive control and mediofrontal theta oscillations', 'transdiagnostic risk', 'mediofrontal activity']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0035827', 'cui_str': 'Rumanian language'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0419195', 'cui_str': 'Foster care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",136.0,0.0417503,"Institutional rearing (neglect) predicted reduced mediofrontal theta by age 16, which was linked to heightened transdiagnostic risk for psychopathology (P factor); no specific associations with internalizing/externalizing factors were present once transdiagnostic risk was accounted for.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Buzzell', 'Affiliation': 'University of Maryland, College Park, MD, United States. Electronic address: gbuzzell@umd.edu.'}, {'ForeName': 'Sonya V', 'Initials': 'SV', 'LastName': 'Troller-Renfree', 'Affiliation': 'Teachers College, Columbia University, NY, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wade', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ranjan', 'Initials': 'R', 'LastName': 'Debnath', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Morales', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Maureen E', 'Initials': 'ME', 'LastName': 'Bowers', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}, {'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Zeanah', 'Affiliation': 'Tulane University School of Medicine, New Orleans, LA, United States.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Nelson', 'Affiliation': ""Harvard Medical School, Boston, MA, United States; Boston Children's Hospital, Boston, MA, United States; Harvard Graduate School of Education, Boston, MA, United States.""}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Fox', 'Affiliation': 'University of Maryland, College Park, MD, United States.'}]",Developmental cognitive neuroscience,['10.1016/j.dcn.2020.100777']
96,32315965,Baduanjin mind-body exercise improves logical memory in long-term hospitalized patients with schizophrenia: A randomized controlled trial.,"Neurocognitive impairment is one of the core symptoms in schizophrenia and poses a great challenge to effective treatment. Sixty-one long-term hospitalized patients with schizophrenia were recruited and randomly assigned to two groups: Baduanjin exercise and brisk walking. Patients in the Baduanjin group received 24 weeks of Baduanjin training (5 days/week, 40 min/day), while patients in the brisk walking group received 24 weeks of brisk walking (5 days/week, 40 min/day). Scores on the Wechsler Memory Scale, Digit Symbol Substitution Test (DSST), and the positive and negative syndrome scale were used to evaluate the logical memory (LM), processing speed, and clinical symptoms of all participants, while the score of Trail Making Test-A (TMT-A) was applied to assess the visual attention and graphomotor speed, at baseline and the 16th week and 24th week of intervention. The one-way repeated measures analysis of variance (ANOVA) was used to test the differences in neurocognitive changes between the two groups. Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328). A significant effect of time was also detected in the LM immediate (F=10.24, p = 0.000) and LM delayed (F=4.93, p = 0.009) scores and in the completion time of the TMT-A (F=33.10, p = 0.000), but not in the DSST scores (F=2.12, p = 0.122). Baduanjin exercise could improve logical memory in the long-term hospitalized patients with schizophrenia.",2020,"Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328).","['long-term hospitalized patients with schizophrenia', 'hospitalized patients with schizophrenia', 'Sixty-one long-term hospitalized patients with schizophrenia']","['Baduanjin exercise', 'Baduanjin training', 'brisk walking group received 24 weeks of brisk walking', 'Baduanjin exercise and brisk walking', 'Baduanjin mind-body exercise']","['LM immediate', 'logical memory (LM), processing speed, and clinical symptoms', 'neurocognitive changes', 'LM delayed', 'logical memory', 'visual attention and graphomotor speed', 'completion time of the TMT-A', 'Wechsler Memory Scale, Digit Symbol Substitution Test (DSST), and the positive and negative syndrome scale', 'DSST scores']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C4517832', 'cui_str': '61'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443162', 'cui_str': 'Brisk'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0589102', 'cui_str': 'Visual attention'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.0321369,"Repeated measures ANOVA showed significant differences between the two groups in the LM immediate (F = 6.21, p = 0.003) and LM delayed (F=5.60, p = 0.005) scores, but not in the completion times of TMT-A (F=.22, p = 0.806) or DSST scores (F=0.97, p = 0.328).","[{'ForeName': 'Mingli', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Mental Health Center and Psychiatric Laboratory, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China; The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China. Electronic address: limingli0517@qq.com.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Yusubujiang', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': ""The Mental Rehabilitation Centers, Karamay Municipal People's Hospital, Karamay, Xinjiang 830054, China. Electronic address: 577827619@qq.com.""}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102046']
97,32196898,Safety and efficacy of step-down to oral outpatient treatment versus inpatient antimicrobial treatment in pediatric cancer patients with febrile neutropenia: A noninferiority multicenter randomized clinical trial.,"BACKGROUND


It has been suggested that low-risk febrile neutropenia (FN) episodes can be treated in a step-down manner in the outpatient setting. This recommendation has been limited to implementation in middle-income countries due to concerns about infrastructure and lack of trained personnel. We aimed to determine whether early step-down to oral antimicrobial outpatient treatment is not inferior in safety and efficacy to inpatient intravenous treatment in children with low-risk FN.
PROCEDURE


A noninferiority randomized controlled clinical trial was conducted in three hospitals in Mexico City. Low-risk FN was identified in children younger than 18 years. After 48 to 72 hours of intravenous treatment, children were randomly allocated to receive outpatient oral treatment (experimental arm, cefixime) or to continue inpatient treatment (standard of care, cefepime). Daily monitoring was performed until neutropenia resolution. The presence of any unfavorable clinical outcome was the endpoint of interest. We performed a noninferiority test for comparison of proportions.
RESULTS


We identified 1237 FN episodes; 117 cases were randomized: 60 to the outpatient group and 57 for continued inpatient treatment. Of the FN episodes, 100% in the outpatient group and 93% in the inpatient group had a favorable outcome (P < 0.001). The mean duration of antibiotics was 4.1 days (SD 2.5; 95% CI, 3.4-4.8 days) in the outpatient group and 4.4 days (SD 2.5; 95% CI, 3.7-5.0 days) in the inpatient group (P = 0.70).
CONCLUSIONS


In our population, step-down oral outpatient treatment of low-risk FN was as safe and effective as inpatient intravenous treatment. Clinical Trials Identifier: NCT04000711.",2020,"In our population, step-down oral outpatient treatment of low-risk FN was as safe and effective as inpatient intravenous treatment.","['1237 FN episodes; 117 cases were randomized: 60 to the outpatient group and 57 for continued inpatient treatment', 'children younger than 18 years', 'children with low-risk FN', 'pediatric cancer patients with febrile neutropenia', 'three hospitals in Mexico City']","['outpatient oral treatment (experimental arm, cefixime', 'step-down to oral outpatient treatment versus inpatient antimicrobial treatment']","['Safety and efficacy', 'safety and efficacy', 'mean duration of antibiotics']","[{'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0060400', 'cui_str': 'Cefixime'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]",117.0,0.139808,"In our population, step-down oral outpatient treatment of low-risk FN was as safe and effective as inpatient intravenous treatment.","[{'ForeName': 'Martha J', 'Initials': 'MJ', 'LastName': 'Avilés-Robles', 'Affiliation': 'Infectious Diseases Department, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Reyes-López', 'Affiliation': 'Center of Economics and Social Studies in Health, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Otero-Mendoza', 'Affiliation': 'Infectious Diseases Department, Instituto Nacional de Pediatría, Mexico City, Mexico.'}, {'ForeName': 'Amilcar U', 'Initials': 'AU', 'LastName': 'Valencia-Garin', 'Affiliation': 'Division of Pediatric, Hospital Juárez de México, Mexico City, Mexico.'}, {'ForeName': 'José G', 'Initials': 'JG', 'LastName': 'Peñaloza-González', 'Affiliation': 'Division of Pediatric, Hospital Juárez de México, Mexico City, Mexico.'}, {'ForeName': 'Rómulo E', 'Initials': 'RE', 'LastName': 'Rosales-Uribe', 'Affiliation': 'Subdivision of Integral Attention to the Patient, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Onofre', 'Initials': 'O', 'LastName': 'Muñoz-Hernández', 'Affiliation': 'National Medical Arbitration Commission, Mexico City, Mexico.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Garduño-Espinosa', 'Affiliation': 'Research Department, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Juárez-Villegas', 'Affiliation': 'Oncology Department, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Zapata-Tarrés', 'Affiliation': 'Oncology Department, Instituto Nacional de Pediatría, Mexico City, Mexico.'}]",Pediatric blood & cancer,['10.1002/pbc.28251']
98,32376759,"Nasal fentanyl alone plus buccal midazolam: an open-label, randomised, controlled feasibility study in the dying.","INTRODUCTION


Many patients want to stay at home to die. They invariably become unable to take oral medication during their terminal phase. Symptoms are usually controlled by subcutaneous medications. There have been no studies on nasal fentanyl (NF) or buccal midazolam (BM) to control symptoms in the dying.
OBJECTIVE


To establish how best to conduct a definitive, randomised controlled trial (RCT) to determine whether NF and BM administered by families, for patients dying at home, lead to faster and better symptom control and fewer community nursing visits than standard breakthrough medication by healthcare professionals.
METHODS


This open-label mixed-method feasibility RCT compared the efficacy of NF and BM by family members to standard breakthrough medication by nurses for the terminally ill in a specialist palliative care unit. Partway through the study, a third observational arm was introduced where BM alone was used. The primary outcomes were whether recruitment and randomisation were possible, assessment of withdrawal and drop-out, and whether the methods were acceptable and appropriate.
RESULTS


Administration of NF and BM was acceptable to patients and families. Both were well tolerated. We were unable to obtain quality of life data consistently but did get time period data for dose-controlled symptoms.
CONCLUSIONS


Study participation in a hospice population of the dying was acceptable. The results will help guide future community study planning.
TRIAL REGISTRATION NUMBER


NCT02009306.",2020,Both were well tolerated.,"['patients dying at home, lead to faster and better symptom control and fewer community nursing visits than standard breakthrough medication by healthcare professionals']","['buccal midazolam (BM', 'NF and BM', 'Nasal fentanyl alone plus buccal midazolam']",['tolerated'],"[{'cui': 'C0421612', 'cui_str': 'Patient died at home'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],,0.0874566,Both were well tolerated.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Perkins', 'Affiliation': 'Sue Ryder Leckhampton Court Hospice, Cheltenham, Gloucestershire, UK paul.perkins@suerydercare.org.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Parkinson', 'Affiliation': 'Sue Ryder Leckhampton Court Hospice, Cheltenham, Gloucestershire, UK.'}, {'ForeName': 'Ralph Kwame', 'Initials': 'RK', 'LastName': 'Akyea', 'Affiliation': 'Division of Primary Care, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Husbands', 'Affiliation': 'Palliative Medicine, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, Gloucestershire, UK.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2019-002029']
99,32251813,Is Full Endoscopic Lumbar Discectomy Less Invasive Than Conventional Surgery? A Randomized MRI Study.,"BACKGROUND


In the present randomized prospective study, we compared the surgical invasiveness using a quantitative volumetric analysis of postoperative paravertebral muscle signal intensity changes between transforaminal full endoscopic lumbar discectomy (FELD) and open discectomy (OD).
METHODS


We prospectively collected the data from 50 patients with a single-level lumbar foraminal herniation, invalidating radicular pain, and adequate imaging studies available (postoperative magnetic resonance imaging [MRI] <24 hours). These patients had been randomly assigned to FELD (n = 25) or OD (n = 25). Data were collected on age, sex, leg and back pain, complications, and follow-up time. Muscle segmentations were performed manually using 3DSlicer software on postoperative isovolumetric T1-weighted contrast-enhanced and T2-weighted short tau inversion recovery MRI scans. Both sequences were processed using multiplanar reconstruction in orthogonal planes. The clinical and demographic characteristics and volumetric data were then compared between the 2 groups.
RESULTS


We found a higher mean volume of paravertebral muscle signal alterations among the OD-treated patients in both T2-weighted short tau inversion recovery MRI (P ≤ 0.001) and T1-weighted contrast-enhanced MRI (P ≤ 0.001) scans than among the FELD-treated patients. No differences were found between the median preoperative and postoperative leg pain between the 2 groups (P = 1.000). The median scores for postoperative back pain were significantly lower for the FELD group (P ≤ 0.001), as was the median interval from surgery to autonomous mobilization (P = 0.001).
CONCLUSIONS


We found a significant difference in signal intensity of the paravertebral muscles between the FELD and OD groups, reflective of the minor surgical invasiveness of endoscopic discectomy. FELD resulted in less trauma to the paraspinal muscles, possibly also reducing inflammatory cytokine release and, therefore, is a valuable tool for spinal surgeons.",2020,"Median values for postoperative back pain were significantly lower for FELD patients (p-value=<0.001), as long as the median time from operation to patients autonomous mobilization (p-value=0.001).
","['50 patients with a single-level lumbar foraminal herniation, an invalidating radicular pain, and adequate imaging (postoperative MRI < 24 hours']","['transforaminal full-endoscopic lumbar discectomy (FELD) and open discectomy (OD', 'FELD']","['median preoperative and postoperative leg pain', 'Median values for postoperative back pain', 'signal intensity of paravertebral muscles', 'mean volume of paravertebral muscle signal alterations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0441996', 'cui_str': 'Foraminal'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0439584', 'cui_str': '24 hours'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",50.0,0.066437,"Median values for postoperative back pain were significantly lower for FELD patients (p-value=<0.001), as long as the median time from operation to patients autonomous mobilization (p-value=0.001).
","[{'ForeName': 'Leonello', 'Initials': 'L', 'LastName': 'Tacconi', 'Affiliation': 'Neurosurgical Department, Azienda Sanitaria Universitaria Integrata di Trieste, Trieste, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Signorelli', 'Affiliation': 'Division of Neurosurgery, Department of Basic Medical Sciences, Neurosciences and Sense Organs, University ""Aldo Moro"" of Bari, Bari, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Giordan', 'Affiliation': 'Neurosurgical Department, Azienda ULSS 2 Marca Trevigiana, Treviso, Veneto, Italy. Electronic address: enrico.giordan@aulss2.veneto.it.'}]",World neurosurgery,['10.1016/j.wneu.2020.03.123']
100,32232698,Long-term (up to 16 months) health-related quality of life after adjuvant tailored dose-dense chemotherapy vs. standard three-weekly chemotherapy in women with high-risk early breast cancer.,"PURPOSE


To prospectively compare HRQoL effects of two modern adjuvant chemotherapy breast cancer treatment regimens at six time-points up to 16 months after random assignment.
METHODS


The open-label, randomized, Phase 3 ""Panther trial"" was conducted between February 2007 and September 2011. 760 women, aged 65 years and younger, after surgery for non-metastatic node-positive or high-risk node-negative breast cancer were randomized 1:1 to the experimental group (four cycles of tailored and dose-dense adjuvant epirubicin and cyclophosphamide/2 weeks followed by four cycles of tailored dose-dense docetaxel/2 weeks) or standard group (three cycles of fluorouracil and epirubicin-cyclophosphamide/3 weeks followed by three cycles of docetaxel/3 weeks). HRQoL was assessed at all Swedish centres using EORTC QLQ-C30 and EORTC QLQ-BR23 at six points during 16 months before randomization.
RESULTS


Response rates to questionnaires were highest at baseline 728/780 (93%) and lowest 16 months after randomization, 557/750 (74%). HRQoL declined during treatment in both groups. At the end of treatment, the experimental group reported statistically significantly lower HRQoL (P < 0.001) than the standard group on global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects. No differences were found for emotional functioning, body image, and arm and breast symptoms. There were no statistically significant differences between the groups at the first follow-up and at subsequent assessments. HRQoL levels at the 16-month follow-up were similar to baseline values.
CONCLUSIONS


Negative HRQoL impact of the dose-dense and tailored strategy appears to be prominent during treatment, but HRQoL recover once treatment ends.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT00798070; isrctn.org Identifier: ISRCTN39017665.",2020,"At the end of treatment, the experimental group reported statistically significantly lower HRQoL (P < 0.001) than the standard group on global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects.","['two modern adjuvant chemotherapy breast cancer treatment regimens at six time-points up to 16\xa0months after random assignment', '760 women, aged 65\xa0years and younger, after surgery for non-metastatic node-positive or high-risk node-negative breast cancer', 'women with high-risk early breast cancer']","['tailored and dose-dense adjuvant epirubicin and cyclophosphamide/2\xa0weeks followed by four cycles of tailored dose-dense docetaxel/2\xa0weeks) or standard group (three cycles of fluorouracil and epirubicin-cyclophosphamide/3', 'adjuvant tailored dose-dense chemotherapy vs. standard three-weekly chemotherapy']","['HRQoL levels', 'emotional functioning, body image, and arm and breast symptoms', 'HRQoL', 'HRQoL effects', 'health-related quality of life', 'global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects']","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",760.0,0.0933665,"At the end of treatment, the experimental group reported statistically significantly lower HRQoL (P < 0.001) than the standard group on global health status, physical functioning, role functioning, social functioning, fatigue, sexual functioning, and systemic therapy effects.","[{'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Brandberg', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden. yvonne.brandberg@ki.se.'}, {'ForeName': 'Hemming', 'Initials': 'H', 'LastName': 'Johansson', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hellström', 'Affiliation': 'Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Möbus', 'Affiliation': 'Department of Gynecology and Obstetrics, Goethe University Frankfurt/M, Frankfurt, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'Medical Department, Medical University Hospital, Salzburg, Austria.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Foukakis', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Bergh', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Breast cancer research and treatment,['10.1007/s10549-020-05602-9']
101,32145674,"A double-blind, randomized, sham-controlled study of cranial electrotherapy stimulation as an add-on treatment for tic disorders in children and adolescents.","AIM


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


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


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


Four-week's treatment of CES for children and adolescents with TD is effective and safe, but the improvement for tic severity may be related to placebo effect.",2020,"Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
","[""62 patients aged 6-17 years with TD and lack of clinical response to 4 weeks' pharmacotherapy were enrolled"", 'tic disorders in children and adolescents', '53 patients (34 males and 9 females) completed the trial, including 29 in the active CES group and 24 in the sham CES group']","['cranial electrotherapy stimulation', 'active CES', 'cranial electrotherapy stimulation (CES', 'active CES (500\u2009μA-2\u2009mA) or sham CES']","['clinical improvement in tic severities', 'Yale Global Tic Severity Scale (YGTSS), Clinical Global Impression-severity of illness-severity (CGI-S) and Hamilton Anxiety', 'efficacy and safety', 'Adverse events (AEs', 'YGTSS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0040188', 'cui_str': 'Tic disorder (disorder)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0013787', 'cui_str': 'Electrical Stimulation Therapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4720888', 'cui_str': 'Yale global tic severity scale (assessment scale)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",62.0,0.38816,"Participants receiving active CES showed a reduction of 31.66 % in YGTSS score, compared with 23.96 % in participants in sham CES group, resulting in no significant difference between the two groups (t = 1.54, p = 0.13).
","[{'ForeName': 'Wen-Jun', 'Initials': 'WJ', 'LastName': 'Wu', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: wenjun104@126.com.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: fgx995@163.com.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Cai', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: caimin@fmmu.edu.cn.""}, {'ForeName': 'Yi-Huan', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: 182368179@qq.com.""}, {'ForeName': 'Cui-Hong', 'Initials': 'CH', 'LastName': 'Zhou', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: zch4610@126.com.""}, {'ForeName': 'Hua-Ning', 'Initials': 'HN', 'LastName': 'Wang', 'Affiliation': ""Department of Psychiatry, Xijing Hospital, Fourth Military Medical University, 127# West Changle Road, Xi'an, 710032, China. Electronic address: xskzhu@fmmu.edu.cn.""}, {'ForeName': 'Long-Biao', 'Initials': 'LB', 'LastName': 'Cui', 'Affiliation': ""Department of Clinical Psychology, School of Medical Psychology, Fourth Military Medical University, 169 # West Changle Road, Xi'an, 710032, China. Electronic address: lbcui@fmmu.edu.cn.""}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.101992']
102,32332636,Effect of electroacupuncture on diabetic neurogenic bladder: A randomized controlled trial protocol.,"BACKGROUND


The most common and bothersome lower urinary tract complication of diabetes mellitus is diabetic neurogenic bladder (DNB). Acupuncture has certain advantages in treating bladder dysfunction including urinary retention and incontinence. Therefore, we think that electroacupuncture (EA) may be beneficial to DNB patients. However, it is not clear whether EA combined with basic western medicine could optimize the therapeutic effect for DNB.
METHOD/DESIGN


This is a sham-controlled, patient-blinded, pioneer randomized controlled trial (RCT). One hundred fifty eligible patients will be randomly divided into 3 groups: A. basic western medicine (BWC), B. EA with BWC, C. sham EA with BWC. EA treatment will be given twice a week for 12 weeks at bilateral BL23, BL32, BL33, and BL35. The BWC group will received Alpha-lipoic acid (ALA) and methylcobalamin (MC) treatment for 12 weeks, 2 treatment sessions per week. The primary outcome is scored by the 72-hour bladder diary (72h-BD). The secondary outcomes will be scored by the American Urological Association symptom index (AUA-SI), Post-void residual urine volume (PVR) and urodynamic tests. All the assessments will be conducted at baseline and the 12th weeks after the intervention starts. The follow-up assessments will be performed with 72h-BD and AUA-SI in the 4th, 12th, and 24th weeks after intervention ends.
DISCUSSION


This trial protocol provides an example of the clinical application acupuncture treatment in the management of DNB. This RCT will provide us information on the effect of treating DNB patients with only acupuncture, western medicine therapy (ALA + MC) as well as the combination of both. The additive effect or synergistic effect of acupuncture and basic western medicine will then be analyzed.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR2000030421.",2020,"EA treatment will be given twice a week for 12 weeks at bilateral BL23, BL32, BL33, and BL35.","['diabetic neurogenic bladder', 'One hundred fifty eligible patients']","['Alpha-lipoic acid (ALA) and methylcobalamin (MC', 'basic western medicine (BWC), B. EA with BWC, C. sham EA with BWC', 'electroacupuncture', 'Acupuncture', 'electroacupuncture (EA', 'acupuncture']","['72-hour bladder diary (72h-BD', 'American Urological Association symptom index (AUA-SI), Post-void residual urine volume (PVR) and urodynamic tests']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0005697', 'cui_str': 'Neurogenic bladder'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0065844', 'cui_str': 'mecobalamin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0429774', 'cui_str': 'Residual urine volume'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",150.0,0.160783,"EA treatment will be given twice a week for 12 weeks at bilateral BL23, BL32, BL33, and BL35.","[{'ForeName': 'Xuke', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Shengju', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}, {'ForeName': 'Qiu', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Hospital of Chengdu University of Traditional Chinese Medicine.'}]",Medicine,['10.1097/MD.0000000000019843']
103,30935327,"A randomized clinical trial comparing non-thrust manipulation with segmental and distal dry needling on pain, disability, and rate of recovery for patients with non-specific low back pain.","Objective : The purpose of this study was to examine the within and between-group effects of segmental and distal dry needling (DN) without needle manipulation to a semi-standardized non-thrust manipulation (NTM) targeting the symptomatic spinal level for patients with non-specific low back pain (NSLBP).  Methods : Sixty-five patients with NSLBP were randomized to receive either DN ( n  = 30) or NTM ( n  = 35) for six sessions over 3 weeks. Outcomes collected included the oswestry disability index (ODI), patient specific functional scale (PSFS), numeric pain rating scale (NPRS), and pain pressure thresholds (PPT). At discharge, patients perceived recovery was assessed.  Results : A two-way mixed model ANOVA demonstrated that there was no group*time interaction for PSFS ( p  = 0.26), ODI ( p  = 0.57), NPRS ( p  = 0.69), and PPT ( p  = 0.51). There was significant within group effects for PSFS (3.1 [2.4, 3.8],  p  = 0.018), ODI (14.5% [10.0%, 19.0%],  p  = 0.015), NPRS (2.2 [1.5, 2.8],  p  = 0.009), but not for PPT (3.3 [0.5, 6.0],  p  = 0.20).  Discussion : The between-group effects were neither clinically nor statistically significant. The within group effects were both significant and exceeded the reported minimum clinically important differences for the outcomes tools except the PPT. DN and NTM produced comparable outcomes in this sample of patients with NSLBP. Level of evidence: 1b.",2019,"There was significant within group effects for PSFS (3.1 [2.4, 3.8],  p  = 0.018), ODI (14.5% [10.0%, 19.0%],  p  = 0.015), NPRS (2.2 [1.5, 2.8],  p  = 0.009), but not for PPT (3.3 [0.5, 6.0],  p  = 0.20).  ","['patients with non-specific low back pain', 'patients with NSLBP', 'Sixty-five patients with NSLBP', 'patients with non-specific low back pain (NSLBP', 'Discussion ']","['NTM', 'non-thrust manipulation with segmental and distal dry needling', 'DN and NTM', 'segmental and distal dry needling (DN) without needle manipulation to a semi-standardized non-thrust manipulation (NTM', 'DN']","['pain, disability, and rate of recovery', 'group*time interaction for PSFS', 'oswestry disability index (ODI), patient specific functional scale (PSFS), numeric pain rating scale (NPRS), and pain pressure thresholds (PPT', 'PSFS', 'NPRS', 'ODI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}]","[{'cui': 'C1265234', 'cui_str': 'Non-Tuberculous Mycobacteria'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}]",65.0,0.105789,"There was significant within group effects for PSFS (3.1 [2.4, 3.8],  p  = 0.018), ODI (14.5% [10.0%, 19.0%],  p  = 0.015), NPRS (2.2 [1.5, 2.8],  p  = 0.009), but not for PPT (3.3 [0.5, 6.0],  p  = 0.20).  ","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Griswold', 'Affiliation': 'a Department of Physical Therapy , Youngstown State University , Youngstown , OH , USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gargano', 'Affiliation': 'b President of Integrative Dry Needling , Solon , OH , USA.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Learman', 'Affiliation': 'a Department of Physical Therapy , Youngstown State University , Youngstown , OH , USA.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2019.1574389']
104,30935335,The immediate effects of cervical spine manipulation on pain and biochemical markers in females with acute non-specific mechanical neck pain: a randomized clinical trial.,"Study Design : Randomized clinical trial with pre-test, post-test control group design.  Objectives : To examine the immediate effects of cervical spinal manipulation (CSM) on serum concentration of biochemical markers (oxytocin, neurotensin, orexin A, and cortisol).  Background : Several studies have found an association between spinal manipulation (SM) and pain perception. However, the mechanism by which SM modulates pain remains undefined.  Methods : Twenty-eight female subjects with non-specific mechanical neck pain were randomly assigned to one of two interventions (CSM versus sham CSM). Blood samples were drawn before and immediately after the respective interventions. Oxytocin, neurotensin, orexin A, and cortisol were measured from the blood and serum using the Milliplex Map Magnetic Bead Panel Immunoassay on the Luminex 200 Platform.  Results : In the CSM group, there were significant increases in pre- versus post-manipulation mean oxytocin (154.5 ± 60.1 vs. 185.1 ± 75.6,  p  = .012); neurotensin (116.0 ± 26.5 vs.136.4 ± 34.1,  p  < . 001); orexin A (52.2 ± 31.1 vs. 73.8 ± 38.8,  p  < .01) serum concentration; but no significant differences in mean cortisol ( p  = .052) serum concentration. In the sham group, there were no significant differences in any of the biomarkers ( p  > .05).  Conclusion : The results of the current study suggest that the mechanical stimuli provided through a CSM may modify neuropeptide expression by immediately increasing the serum concentration of nociception-related biomarkers (oxytocin, neurotensin, orexin A, but not cortisol) in the blood of female subjects with non-specific mechanical neck pain.",2019,"orexin A (52.2 ± 31.1 vs. 73.8 ± 38.8, p < .01) serum concentration; but no significant differences in mean cortisol (p = .052) serum concentration.","['females with acute non-specific mechanical neck pain', '001', 'Twenty-eight female subjects with non-specific mechanical neck pain', 'female subjects with non-specific mechanical neck pain']","['cervical spine manipulation', 'cervical spinal manipulation (CSM', 'two interventions (CSM versus sham CSM']","['mean cortisol', 'serum concentration of biochemical markers (oxytocin, neurotensin, orexin A, and cortisol', 'pain and biochemical markers', 'Oxytocin, neurotensin, orexin A, and cortisol']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0728985', 'cui_str': 'Cervical spine'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0086586', 'cui_str': 'Manipulation, Spinal'}, {'cui': 'C4521841', 'cui_str': 'MGySgt'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0027930', 'cui_str': 'Neurotensin'}, {'cui': 'C0671870', 'cui_str': 'Hypocretin-1'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",28.0,0.0895313,"orexin A (52.2 ± 31.1 vs. 73.8 ± 38.8, p < .01) serum concentration; but no significant differences in mean cortisol (p = .052) serum concentration.","[{'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Lohman', 'Affiliation': 'a School of Allied Health Professions, Physical Therapy Department, Loma Linda University , Loma Linda , CA , USA.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Pacheco', 'Affiliation': 'a School of Allied Health Professions, Physical Therapy Department, Loma Linda University , Loma Linda , CA , USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gharibvand', 'Affiliation': 'b School of Allied Health Professions, Allied Health Studies Department, Loma Linda University , Loma Linda , CA , USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Daher', 'Affiliation': 'b School of Allied Health Professions, Allied Health Studies Department, Loma Linda University , Loma Linda , CA , USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Devore', 'Affiliation': 'b School of Allied Health Professions, Allied Health Studies Department, Loma Linda University , Loma Linda , CA , USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bains', 'Affiliation': 'b School of Allied Health Professions, Allied Health Studies Department, Loma Linda University , Loma Linda , CA , USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'AlAmeri', 'Affiliation': 'a School of Allied Health Professions, Physical Therapy Department, Loma Linda University , Loma Linda , CA , USA.'}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Berk', 'Affiliation': 'b School of Allied Health Professions, Allied Health Studies Department, Loma Linda University , Loma Linda , CA , USA.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2018.1553696']
105,32105625,"Point-of-care HIV viral load testing combined with task shifting to improve treatment outcomes (STREAM): findings from an open-label, non-inferiority, randomised controlled trial.","BACKGROUND


Monitoring HIV treatment with laboratory testing introduces delays for providing appropriate care in resource-limited settings. The aim of our study was to determine whether point-of-care HIV viral load testing with task shifting changed treatment and care outcomes for adults on antiretroviral therapy (ART) when compared with standard laboratory viral load testing.
METHODS


We did an open-label, non-inferiority, randomised controlled trial in a public clinic in Durban, South Africa. We enrolled HIV-positive adults (aged ≥18 years) who presented for their first routine HIV viral load test 6 months after ART initiation. Individuals were randomly assigned by a random number allocation sequence to receive either point-of-care viral load testing at enrolment and after 6 months with task shifting to enrolled nurses (intervention group), or laboratory viral load testing (standard-of-care group). The primary outcome was combined viral suppression (<200 copies per mL) and retention at 12 months after enrolment. A non-inferiority margin of 10% was used. Analysis was done by intention to treat. This study was registered with ClinicalTrials.gov, NCT03066128.
FINDINGS


Between Feb 24, 2017, and Aug 23, 2017, we screened 657 participants, and 390 were enrolled and randomly assigned to either the intervention group (n=195) or standard-of-care group (n=195). 175 (90%) individuals in the intervention group and 148 (76%) individuals in the standard-of-care group had the primary outcome of retention with viral suppression, a difference of 13·9% (95% CI 6·4-21·2; p<0·00040). 182 participants (93%) in the intervention group had viral suppression compared with 162 (83%) in the standard-of-care group (difference 10·3%, 3·9-16·8; p=0·0025); 180 (92%) and 162 (85%) were retained in care (7·7%, 1·3-14·2; p=0·026). There were no adverse events related to point-of-care HIV viral load testing or task shifting.
INTERPRETATION


Point-of-care viral load testing combined with task shifting significantly improved viral suppression and retention in HIV care. Point-of-care testing can simplify treatment and improve outcomes for HIV-positive adults receiving ART in resource-limited settings.
FUNDING


National Institute of Allergy and Infectious Diseases.",2020,"182 participants (93%) in the intervention group had viral suppression compared with 162 (83%) in the standard-of-care group (difference 10·3%, 3·9-16·8; p=0·0025); 180 (92%) and 162 (85%) were retained in care (7·7%, 1·3-14·2; p=0·026).","['adults on antiretroviral therapy (ART', '657 participants, and 390 were enrolled', 'Between Feb 24, 2017, and Aug 23, 2017', 'public clinic in Durban, South Africa', 'enrolled HIV-positive adults (aged ≥18 years) who presented for their first routine HIV viral load test 6 months after ART initiation', 'HIV-positive adults receiving ART in resource-limited settings']","['random number allocation sequence to receive either point-of-care viral load testing at enrolment and after 6 months with task shifting to enrolled nurses (intervention group), or laboratory viral load testing (standard-of-care group', 'intervention group (n=195) or standard-of-care group']","['viral suppression and retention in HIV care', 'viral suppression', 'retention with viral suppression', 'combined viral suppression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]",657.0,0.288793,"182 participants (93%) in the intervention group had viral suppression compared with 162 (83%) in the standard-of-care group (difference 10·3%, 3·9-16·8; p=0·0025); 180 (92%) and 162 (85%) were retained in care (7·7%, 1·3-14·2; p=0·026).","[{'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Drain', 'Affiliation': 'Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA; Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA; Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA, USA. Electronic address: pkdrain@uw.edu.'}, {'ForeName': 'Jienchi', 'Initials': 'J', 'LastName': 'Dorward', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Violette', 'Affiliation': 'Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Justice', 'Initials': 'J', 'LastName': 'Quame-Amaglo', 'Affiliation': 'Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Thomas', 'Affiliation': 'Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Samsunder', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Ngobese', 'Affiliation': 'Prince Cyril Zulu Communicable Disease Clinic, Durban Municipality, Durban, South Africa.'}, {'ForeName': 'Koleka', 'Initials': 'K', 'LastName': 'Mlisana', 'Affiliation': 'School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa; National Health Laboratory Service, Durban, South Africa.'}, {'ForeName': 'Pravikrishnen', 'Initials': 'P', 'LastName': 'Moodley', 'Affiliation': 'School of Laboratory Medicine and Medical Sciences, University of KwaZulu-Natal, Durban, South Africa; National Health Laboratory Service, Durban, South Africa; Department of Virology, Inkosi Albert Luthuli Central Hospital, Cato Manor, South Africa.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ruanne V', 'Initials': 'RV', 'LastName': 'Barnabas', 'Affiliation': 'Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA; Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kogieleum', 'Initials': 'K', 'LastName': 'Naidoo', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa; CAPRISA-MRC HIV-TB Pathogenesis and Treatment Research Unit, and Doris Duke Medical Research Institute, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Salim S', 'Initials': 'SS', 'LastName': 'Abdool Karim', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa; Department of Epidemiology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Celum', 'Affiliation': 'Department of Global Health, School of Public Health and School of Medicine, University of Washington, Seattle, WA, USA; Department of Medicine, School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Garrett', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa; School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30402-3']
106,30513347,Enlarged Areas of Pain and Pressure Hypersensitivityby Spatially Distributed Intramuscular Injections ofLow-Dose Nerve Growth Factor.,"Intramuscular injection of nerve growth factor (NGF) causes muscle hyperalgesia without immediate pain. This double-blinded, randomized study assessed pain and muscle hypersensitivity after a single-site bolus NGF injection (5 µg) compared with 5 spatially distributed, low-dose NGF injections (1 µg, 4 cm distance) into the tibialis anterior (TA) muscles in 20 healthy subjects. Injection pain was rated on a visual analog scale. Reports of muscle pain with functional tasks (Likert scale score) and the presence of spontaneous pain were collected daily by using a diary. Pressure pain threshold (PPT), overall pain intensity (numerical rating scale), and pain areas following the TA contraction were collected at baseline; 3 hours; and 1, 3, 7, 14, and 21 days postinjection. Low immediate visual analog scale scores were associated with both injection protocols. Likert scale scores showed moderate pain intensities but no spontaneous pain, until day 12, for both injection protocols (P < .05). Reduced PPTs at the 5- and 1-µg injection sites were found after 3 hours, lasting until day 7 (P < .05). The 1-µg injection provoked decreased PPTs at day 1 (P = .036) at the proximal injection site and at day 1 (P = .02) and day 3 (P = .01) at the distal injection site. The TA muscle contraction resulted in larger pain areas and higher numerical rating scale scores at day 3 for the distributed injections compared with the single-site injection (P < .001). Perspective: Spatially distributed low-dose NGF injections induced prolonged pain, mechanical muscle hypersensitivity, and enlarged contraction-evoked pain areas. These features mirror some clinical muscle pain conditions in which diffuse pain areas and muscle hypersensitivity are present during the activities of daily living. Low-dose NGF injections may be useful for further studies of prolonged pain conditions.",2019,The TA muscle contraction resulted in larger pain areas and higher numerical rating scale scores at day 3 for the distributed injections compared with the single-site injection (P < .001).,['20 healthy subjects'],"['NGF injections', 'Intramuscular injection of nerve growth factor (NGF', 'NGF injection (5 µg) compared with 5 spatially distributed, low-dose NGF injections']","['PPTs', 'Pressure pain threshold (PPT), overall pain intensity (numerical rating scale), and pain areas following the TA contraction', 'larger pain areas and higher numerical rating scale scores', 'Injection pain', 'pain and muscle hypersensitivity', 'prolonged pain, mechanical muscle hypersensitivity, and enlarged contraction-evoked pain areas', 'Reduced PPTs', 'moderate pain intensities', 'muscle pain with functional tasks (Likert scale score', 'Low immediate visual analog scale scores']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0442800', 'cui_str': 'Enlarged (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",20.0,0.203368,The TA muscle contraction resulted in larger pain areas and higher numerical rating scale scores at day 3 for the distributed injections compared with the single-site injection (P < .001).,"[{'ForeName': 'Line B', 'Initials': 'LB', 'LastName': 'Sørensen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI.'}, {'ForeName': 'Shellie A', 'Initials': 'SA', 'LastName': 'Boudreau', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Gazerani', 'Affiliation': 'Biomedicine, Department of Health Science and Technology, Faculty of Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Graven-Nielsen', 'Affiliation': 'Center for Neuroplasticity and Pain (CNAP), SMI. Electronic address: tgn@hst.aau.dk.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2018.11.005']
107,32332590,Effect of cognitive-behavioral therapy with music therapy in reducing physics test anxiety among students as measured by generalized test anxiety scale.,"BACKGROUND


The study determined the effect of cognitive-behavioral therapy (CBT) with music in reducing physics test anxiety among secondary school students as measured by generalized test anxiety scale.
METHODS


Pre-test post-test randomized control trial experimental design was adopted in this study. A total of 83 senior secondary students including male (n = 46) and female (n = 37) from sampled secondary schools in Enugu State, Nigeria, who met the inclusion criteria constituted participants for the study. A demographic questionnaire and a 48-item generalized test anxiety scale were used for data collection for the study. Subjects were randomized into treatment and control groups. The treatment group was exposed to a 12-week CBT-music program. Thereafter, the participants in the treatment group were evaluated at 3 time points. Data collected were analyzed using repeated measures analysis of variance.
RESULTS


The participants who were exposed to CBT-music intervention program significantly had lower test anxiety scores at the post-treatment than the participants in the control group. Furthermore, the test anxiety scores of the participants in the CBT-music group were significantly lower than those in the control group at the follow-up measure. Thus, the results showed a significant effect of CBT with music in reducing physics test anxiety among secondary school students.
CONCLUSION


We concluded that CBT-music program has a significant benefit in improving the management of physics test anxiety among secondary school students.",2020,"Furthermore, the test anxiety scores of the participants in the CBT-music group were significantly lower than those in the control group at the follow-up measure.","['83 senior secondary students including male (n\u200a=\u200a46) and female (n\u200a=\u200a37) from sampled secondary schools in Enugu State, Nigeria, who met the inclusion criteria constituted participants for the study', 'secondary school students']","['CBT-music intervention program', 'CBT-music program', 'cognitive-behavioral therapy with music therapy', 'CBT', 'cognitive-behavioral therapy (CBT']","['generalized test anxiety scale', 'test anxiety scores', 'physics test anxiety']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0039577', 'cui_str': 'Test Anxiety Questionnaire'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031837', 'cui_str': 'Physics'}]",83.0,0.0210617,"Furthermore, the test anxiety scores of the participants in the CBT-music group were significantly lower than those in the control group at the follow-up measure.","[{'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Ugwuanyi', 'Affiliation': 'Postdoctoral fellow, School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Moses O', 'Initials': 'MO', 'LastName': 'Ede', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Charity N', 'Initials': 'CN', 'LastName': 'Onyishi', 'Affiliation': ''}, {'ForeName': 'Osita V', 'Initials': 'OV', 'LastName': 'Ossai', 'Affiliation': ''}, {'ForeName': 'Edith N', 'Initials': 'EN', 'LastName': 'Nwokenna', 'Affiliation': 'Department of Art Education, Faculty of Education, University of Nigeria, Nsukka.'}, {'ForeName': 'Lauretta C', 'Initials': 'LC', 'LastName': 'Obikwelu', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Amaka', 'Initials': 'A', 'LastName': 'Ikechukwu-Ilomuanya', 'Affiliation': ''}, {'ForeName': 'Chijioke V', 'Initials': 'CV', 'LastName': 'Amoke', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Agnes O', 'Initials': 'AO', 'LastName': 'Okeke', 'Affiliation': 'Postdoctoral fellow, School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Catherine U', 'Initials': 'CU', 'LastName': 'Ene', 'Affiliation': 'Postdoctoral fellow, School of Education Studies, Faculty of Education, University of the Free State, Bloemfontein, South Africa.'}, {'ForeName': 'Edmund E', 'Initials': 'EE', 'LastName': 'Offordile', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Lilian C', 'Initials': 'LC', 'LastName': 'Ozoemena', 'Affiliation': 'Department of Educational Foundations.'}, {'ForeName': 'Maduka L', 'Initials': 'ML', 'LastName': 'Nweke', 'Affiliation': 'Department of Physiology, Faculty of Basic Medical Sciences, College of Medicine, University of Nigeria, Ituku-Ozalla, Enugu State, Nigeria.'}]",Medicine,['10.1097/MD.0000000000016406']
108,30107241,"Cost-Effectiveness and Cost-Utility of Internet-Delivered Exposure Therapy for Fibromyalgia: Results From a Randomized, Controlled Trial.","Fibromyalgia (FM) is a prevalent and debilitating chronic pain disorder associated with a substantial economic burden. Although there are several studies investigating the effectiveness of psychological treatments such as cognitive-behavioral therapy for FM, studies on cost-effectiveness are scarce. The aim of the present study was to investigate the cost-effectiveness of Internet-delivered exposure therapy (iExp) for FM. We used health economic data from a recently conducted randomized, controlled trial, where 140 participants were randomized to either iExp or a waitlist control (WLC) condition. Economic data were collected at pre-treatment, post-treatment, and at the 1-year follow-up. Treatment effectiveness in relation to costs were analyzed using both a societal perspective (including all direct and indirect costs) and a health care unit perspective (including only the direct treatment costs). Bootstrapped net benefit regression analyses were also conducted, comparing the difference in costs and effects between iExp and WLC, within different willingness-to-pay scenarios. Results showed that the incremental cost-effectiveness ratio was -$15,295, indicating that iExp was highly cost-effective as each successfully treated case (treatment responder) was associated with a substantial net reduction in costs. The robustness of the results was tested in 2 different sensitivity analyses, where iExp remained cost-effective, even in a willingness-to-pay-scenario of $0. We conclude that iExp is a cost-effective treatment that generates large societal cost savings. PERSPECTIVE: Health-economic evaluations of psychological interventions for FM are scarce. This study is a cost-effectiveness analysis of Internet-delivered exposure therapy for patients with FM. Results showed that iExp was highly cost-effective compared with no treatment, where each successfully treated case generated a substantial societal cost saving.",2019,"The robustness of the results was tested in 2 different sensitivity analyses, where iExp remained cost-effective, even in a willingness-to-pay-scenario of $0.","['Fibromyalgia', 'patients with FM', '140 participants']","['iExp or a waitlist control (WLC) condition', 'Internet-delivered exposure therapy', 'Internet-Delivered Exposure Therapy', 'FM', 'Internet-delivered exposure therapy (iExp']","['substantial societal cost saving', 'Cost-Effectiveness and Cost-Utility', 'incremental cost-effectiveness ratio', 'cost-effectiveness']","[{'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",140.0,0.0421364,"The robustness of the results was tested in 2 different sensitivity analyses, where iExp remained cost-effective, even in a willingness-to-pay-scenario of $0.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden. Electronic address: maria.hedman-lagerlof@ki.se.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Rikard K', 'Initials': 'RK', 'LastName': 'Wicksell', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden; Functional Area Medical Psychology, Karolinska University Hospital Solna, Sweden.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Flink', 'Affiliation': 'Örebro University, Center for Health and Medical Psychology (CHAMP), Örebro, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Neuroscience, Division of Psychology, Karolinska Institutet, Stockholm, Sweden.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2018.07.012']
109,32332617,"Effectiveness of a multifactorial intervention, consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise, in patients with uncontrolled hypertension taking 2 or more antihypertensive drugs: The MEDICHY study.","INTRODUCTION


High blood pressure is the leading modifiable risk factor for cardiovascular disease, and is associated with high morbidity and mortality and with significant health care costs for individuals and society. However, fewer than half of the patients with hypertension receiving pharmacological treatment have adequate blood pressure control. The main reasons for this are therapeutic inertia, lack of adherence to treatment, and unhealthy lifestyle (i.e., excess dietary fat and salt, sedentary lifestyle, and overweight). Cardiovascular risk and mortality are greater in hypertensive patients who are receiving treatment but have suboptimal control of blood pressure.
METHODS/DESIGN


This is a multicentre, parallel, 2-arm, single-blind (outcome assessor), controled, cluster-randomized clinical trial. General practitioners and nurses will be randomly allocated to the intervention group (self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise) or the control group (regular clinical practice). A total of 424 patients in primary care centers who use 2 or more antihypertensive drugs and blood pressure of at least 130/80 during 24-hambulatory blood pressure monitoring will be recruited. The primary outcome is systolic blood pressure at 12 months. The secondary outcomes are blood pressure control (<140/90 mm Hg); quality of life (EuroQol 5D); direct health care costs; adherence to use of antihypertensive medication; and cardiovascular risk (REGICOR and SCORE scales).
DISCUSSION


This trial will be conducted in the primary care setting and will evaluate the impact of a multifactorial intervention consisting of self-management of blood pressure, antihypertensive medications, and lifestyle modifications (hypocaloric and low sodium diet and physical exercise).",2020,"Cardiovascular risk and mortality are greater in hypertensive patients who are receiving treatment but have suboptimal control of blood pressure.
","['patients with uncontrolled hypertension taking 2 or more antihypertensive drugs', 'General practitioners and nurses', 'hypertensive patients who are receiving treatment but have suboptimal control of blood pressure', '424 patients in primary care centers who use 2 or more antihypertensive drugs and blood pressure of at least 130/80 during 24-hambulatory blood pressure monitoring will be recruited']","['multifactorial intervention, consisting of self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise', 'blood pressure, antihypertensive medications, and lifestyle modifications (hypocaloric and low sodium diet and physical exercise', 'intervention group (self-management of antihypertensive medication, self-measurement of blood pressure, hypocaloric and low sodium diet, and physical exercise) or the control group (regular clinical practice']","['systolic blood pressure', 'Cardiovascular risk and mortality', 'adequate blood pressure control', 'blood pressure control (<140/90\u200amm Hg); quality of life (EuroQol 5D); direct health care costs; adherence to use of antihypertensive medication; and cardiovascular risk (REGICOR and SCORE scales']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0012169', 'cui_str': 'Low sodium diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",424.0,0.0453177,"Cardiovascular risk and mortality are greater in hypertensive patients who are receiving treatment but have suboptimal control of blood pressure.
","[{'ForeName': 'Fabián', 'Initials': 'F', 'LastName': 'Unda Villafuerte', 'Affiliation': ""Coll D'en Rabassa Healthcare Centre.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Llobera Cànaves', 'Affiliation': 'Primary Care Research Unit of Mallorca, Balearic Health Services (IB-Salut).'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Lorente Montalvo', 'Affiliation': 'Santa Ponça Health Care Centre.'}, {'ForeName': 'María Lucía', 'Initials': 'ML', 'LastName': 'Moreno Sancho', 'Affiliation': 'Son Cladera Healthcare Centre, Balearic Health Services (IB-Salut).'}, {'ForeName': 'Bartolomé', 'Initials': 'B', 'LastName': 'Oliver Oliver', 'Affiliation': 'Spanish Society of Family and Community Pharmacy.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bassante Flores', 'Affiliation': 'Palliative Care Health Centre.'}, {'ForeName': 'Andreu', 'Initials': 'A', 'LastName': 'Estela Mantolan', 'Affiliation': 'Dalt San Joan Healthcare Centre, Mahó, Menorca.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Pou Bordoy', 'Affiliation': 'Camp Redó Healthcare Centre.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Rodríguez Ruiz', 'Affiliation': 'Primary Care Research Unit of Menorca, Balearic Health Services (IB-Salut), Menorca, Balearic Islands, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Requena Hernández', 'Affiliation': ""Coll D'en Rabassa Healthcare Centre.""}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Leiva', 'Affiliation': 'Primary Care Research Unit of Mallorca, Balearic Health Services (IB-Salut).'}, {'ForeName': 'Matíes', 'Initials': 'M', 'LastName': 'Torrent Quetglas', 'Affiliation': ""Institut d'investigació Sanitària Illes Balears.""}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Coll Benejam', 'Affiliation': ""Institut d'investigació Sanitària Illes Balears.""}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': ""D'Agosto Forteza"", 'Affiliation': 'Son Serra La Vileta Healthcare Centre.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Rigo Carratalà', 'Affiliation': ""Institut d'investigació Sanitària Illes Balears.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000019769']
110,32332635,A randomized controlled clinical study of acupuncture therapy for Seborrheic alopecia in young and middle ages: Study protocol clinical trial (SPIRIT compliant).,"INTRODUCTION


Seborrheic alopecia (SA) has clinical manifestations, duration of disease, and priorities. In the current situation where there are many and complicated clinical treatments, Western medicine treatment can delay and control the development of the disease and promote hair regeneration. However, some patients may aggravate symptoms after taking the drug, and the condition is easy to repeat after stopping the drug. Acupuncture is an important method for non-surgical treatment of SA, and it has various methods, low side effects, high safety, and simple and economical. Therefore, we will use a clinical randomized controlled study to explore the effect of acupuncture on SA, and provide a new idea and reference for the treatment of this disease.
METHODS/DESIGN


We will select 60 patients diagnosed with SA. They will be randomly divided into intervention group and control groups. The control group will be given conventional treatment measures. The intervention group will receive acupuncture. Efficacy will be evaluated by comparing the skin lesion score and dermatological quality of life index before and after treatment.
DISCUSSION


This trial may provide evidence regarding the clinical effectiveness, safety, and cost-effectiveness of acupuncture for patients with SA.
TRIAL REGISTRATION NUMBER


CTR2000030430.",2020,"Efficacy will be evaluated by comparing the skin lesion score and dermatological quality of life index before and after treatment.
","['patients with SA', 'Seborrheic alopecia in young and middle ages', '60 patients diagnosed with SA']","['acupuncture therapy', 'Acupuncture', 'acupuncture']",['skin lesion score and dermatological quality of life index'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0037284', 'cui_str': 'Skin lesion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011625', 'cui_str': 'DERMATOLOGICALS'}, {'cui': 'C0451498', 'cui_str': 'Spitzer quality of life index'}]",60.0,0.0791902,"Efficacy will be evaluated by comparing the skin lesion score and dermatological quality of life index before and after treatment.
","[{'ForeName': 'Qiulian', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Graduate student of HeBei North University.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Department of Dermatology,Huabei Petroleum General Hospital.'}, {'ForeName': 'Longjun', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Graduate Student of Hebei University of Chinese medicine.'}, {'ForeName': 'Jinfang', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, The First Hospital of Hebei Medical University.'}, {'ForeName': 'Bichen', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'Department of Traditional Chinese Medicine, Huabei Petroleum General Hospital.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Qin Huang Dao Hospital of Traditional Chinese Medicine of HeBei North University,China.'}]",Medicine,['10.1097/MD.0000000000019842']
111,32334074,Bilateral nucleus basalis of Meynert deep brain stimulation for dementia with Lewy bodies: A randomised clinical trial.,"BACKGROUND


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


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


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


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


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


NCT02263937.",2020,"No consistent improvements were observed in exploratory clinical outcome measures, but the severity of neuropsychiatric symptoms reduced with NBM DBS in 3/5 patients.","['Dementia with Lewy bodies (DLB', 'Patients were aged between 50-80 years, had mild-moderate dementia symptoms and were living with a carer-informant', 'six DLB patients recruited from two UK neuroscience centres', 'DLB patients', 'six patients (five male, mean age 71.33 years']","['NBM DBS', 'Bilateral Nucleus Basalis of Meynert Deep Brain Stimulation', 'image guided stereotactic implantation of bilateral DBS electrodes', 'active or sham stimulation', 'Meynert (NBM DBS']","['severity of neuropsychiatric symptoms', 'tolerated', 'safety and tolerability', 'functional connectivity in discrete cognitive networks on resting state fMRI', 'functional connectivity changes', 'Safety and tolerability', 'standardised measurements of cognitive, psychiatric and motor symptoms', 'antibiotic-associated colitis, prolonging his hospital stay']","[{'cui': 'C0752347', 'cui_str': 'Diffuse Lewy body disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",6.0,0.353614,"No consistent improvements were observed in exploratory clinical outcome measures, but the severity of neuropsychiatric symptoms reduced with NBM DBS in 3/5 patients.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gratwicke', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK. Electronic address: j.gratwicke@ucl.ac.uk.'}, {'ForeName': 'Ludvic', 'Initials': 'L', 'LastName': 'Zrinzo', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Kahan', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Una', 'Initials': 'U', 'LastName': 'Brechany', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'McNichol', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Mazda', 'Initials': 'M', 'LastName': 'Beigi', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Harith', 'Initials': 'H', 'LastName': 'Akram', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hyam', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Oswal', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Day', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mancini', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thornton', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Yousry', 'Affiliation': 'Lynsholm Department of Neuroradiology, The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Sebastian J', 'Initials': 'SJ', 'LastName': 'Crutch', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'John-Paul', 'Initials': 'JP', 'LastName': 'Taylor', 'Affiliation': 'Newcastle University & Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McKeith', 'Affiliation': 'Newcastle University & Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Rochester', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Schott', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Limousin', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burn', 'Affiliation': 'Biomedical Research Building, Newcastle University & Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.'}, {'ForeName': 'Martin N', 'Initials': 'MN', 'LastName': 'Rossor', 'Affiliation': 'Dementia Research Centre, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Hariz', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Jahanshahi', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Foltynie', 'Affiliation': 'Department of Clinical & Movement Neurosciences, UCL Institute of Neurology and the National Hospital for Neurology and Neurosurgery, Queen Square, London, UK. Electronic address: t.foltynie@ucl.ac.uk.'}]",Brain stimulation,['10.1016/j.brs.2020.04.010']
112,32165605,Influence of energy drinks on acute hemodynamic parameters in young healthy adults: a randomized double-blind placebo-controlled crossover pilot study.,,2020,,['young healthy adults'],"['placebo', 'energy drinks']",['acute hemodynamic parameters'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179078', 'cui_str': 'Energy Drinks'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.397032,,"[{'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Stopa', 'Affiliation': ''}, {'ForeName': 'Mateusz', 'Initials': 'M', 'LastName': 'Łobacz', 'Affiliation': ''}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Niemczyk', 'Affiliation': ''}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Rudowska', 'Affiliation': ''}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Radko', 'Affiliation': ''}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Mikunda', 'Affiliation': ''}, {'ForeName': 'Danuta', 'Initials': 'D', 'LastName': 'Czarnecka', 'Affiliation': ''}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Olszanecka', 'Affiliation': ''}]",Kardiologia polska,['10.33963/KP.15231']
113,30368651,"A Qualitative Exploration of Women's Experiences with a Community Health Volunteer-Led Cervical Cancer Educational Module in Migori County, Kenya.","Detection and treatment of human papillomavirus (HPV) and cervical precancer through screening programs is an effective way to reduce cervical cancer deaths. However, high cervical cancer mortality persists in low- and middle-income countries. As screening programs become more widely available, it is essential to understand how knowledge about cervical cancer and perceived disease risk impacts screening uptake and acceptability. We evaluated women's experiences with a cervical cancer education strategy led by community health volunteers (CHVs) in Migori County, Kenya, as part of a cluster randomized controlled trial of cervical cancer screening implementation strategies. The educational modules employed simple language and images and sought to increase understanding of the relationship between HPV and cervical cancer, the mechanisms of self-collected HPV testing, and the importance of cervical cancer screening. Modules took place in three different contexts throughout the study: (1) during community mobilization; (2) prior to screening in either community health campaigns or health facilities; and (3) prior to treatment. Between January and September 2016, we conducted in-depth interviews with 525 participants to assess their experience with various aspects of the screening program. After the context-specific educational modules, women reported increased awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma and emphasized the use of educational modules to reduce stigma. Some misconceptions about cervical cancer were evident. With effective and context-specific training, lay health workers, such as CHVs, can help bridge the gap between cervical cancer screening uptake and acceptability.",2020,"After the context-specific educational modules, women reported increased awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma and emphasized the use of educational modules to reduce stigma.","[""women's experiences with a cervical cancer education strategy led by community health volunteers (CHVs) in Migori County, Kenya"", ""Women's Experiences with a Community Health Volunteer-Led Cervical Cancer Educational Module in Migori County, Kenya"", '525 participants to assess their experience with various aspects of the screening program']",[],"['awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma', 'cervical cancer mortality']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],"[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0196419,"After the context-specific educational modules, women reported increased awareness of cervical cancer screening and willingness to screen, described HPV- and cervical cancer-related stigma and emphasized the use of educational modules to reduce stigma.","[{'ForeName': 'Yujung', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Duke Global Health Institute, Box 90519, 310 Trent Drive, Durham, NC, 27708, USA. yujung.choi@duke.edu.'}, {'ForeName': 'Sandra Y', 'Initials': 'SY', 'LastName': 'Oketch', 'Affiliation': 'Center for Microbiology Research, Kenya Medical Research Institute, P.O. Box 54840 00200, Mbagathi Road, Nairobi, Kenya.'}, {'ForeName': 'Konyin', 'Initials': 'K', 'LastName': 'Adewumi', 'Affiliation': 'Duke Global Health Institute, Box 90519, 310 Trent Drive, Durham, NC, 27708, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bukusi', 'Affiliation': 'Center for Microbiology Research, Kenya Medical Research Institute, P.O. Box 54840 00200, Mbagathi Road, Nairobi, Kenya.'}, {'ForeName': 'Megan J', 'Initials': 'MJ', 'LastName': 'Huchko', 'Affiliation': 'Duke Global Health Institute, Box 90519, 310 Trent Drive, Durham, NC, 27708, USA.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1437-2']
114,30935341,Dry needling versus trigger point compression of the upper trapezius: a randomized clinical trial with two-week and three-month follow-up.,"Objectives : The purpose of this randomized controlled trial was to investigate the long-term clinical effect of dry needling with two-week and three-month follow up, on individuals with myofascial trigger points in the upper trapezius muscle.  Methods : A sample of convenience (33 individuals) with a trigger point in the upper trapezius muscle, participated in this study. The individuals were randomly assigned to two groups: trigger point compression ( N  = 17) or dry needling ( N  = 16). Pain intensity, neck disability, and disability of the arm, hand, and shoulder (DASH) were assessed before treatment, after treatment sessions, and at two-week and three-month follow ups.  Results : The result of repeated measures ANOVA showed significant group-measurement interaction effect for VAS ( p  = .02). No significant interaction was found for NPQ and DASH ( p  > .05). The main effect of measurements for VAS, NPQ, and DASH were statistically significant ( p  < .0001). The results showed a significant change in pain intensity, neck disability, and DASH after treatment sessions, after two weeks and three months when compared with before treatment scores in both groups.  There was no significant difference in the tested variables after two-week or three-month as compared to after treatment sessions between the two groups. However, pain intensity after treatment sessions was significantly different between the two groups ( p  = .02).  Discussion : Dry needling and trigger point compression in individuals with myofascial trigger point in the upper trapezius muscle can lead to three-month improvement in pain intensity and disability.",2019,There was no significant difference in the tested variables after two-week or three-month as compared to after treatment sessions between the two groups.,"['Discussion ', 'individuals with myofascial trigger', 'individuals with myofascial trigger points in the upper trapezius muscle', 'A sample of convenience (33 individuals) with a trigger point in the upper trapezius muscle, participated in this study']","['Dry needling versus trigger point compression of the upper trapezius', 'Dry needling and trigger point compression', 'trigger point compression ( N \xa0=\xa017) or dry needling']","['NPQ and DASH', 'pain intensity and disability', 'Pain intensity, neck disability, and disability of the arm, hand, and shoulder (DASH', 'pain intensity', 'VAS, NPQ, and DASH', 'pain intensity, neck disability, and DASH']","[{'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0224361', 'cui_str': 'Trapezius'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0224361', 'cui_str': 'Trapezius'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}]",,0.0361532,There was no significant difference in the tested variables after two-week or three-month as compared to after treatment sessions between the two groups.,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ziaeifar', 'Affiliation': 'a Department of Physical Therapy , Iran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Amir Massoud', 'Initials': 'AM', 'LastName': 'Arab', 'Affiliation': 'b Department of Physical Therapy , University of Social Welfare and Rehabilitation Sciences , Tehran , Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'b Department of Physical Therapy , University of Social Welfare and Rehabilitation Sciences , Tehran , Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Nourbakhsh', 'Affiliation': 'c Department of Physical Therapy , North Georgia College and State University , Dahlonega , GA , USA.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2018.1530421']
115,30946005,Do prognostic variables predict a set of outcomes for patients with chronic low back pain: a long-term follow-up secondary analysis of a randomized control trial.,"Objective : The objective was to explore for universal prognostic variables, or predictors, across three different outcome measures in patients with chronic low back pain (LBP). We hypothesized that selected prognostic variables would be 'universal' prognostic variables, regardless of the outcome measures used.  Methods : This study was a secondary analysis of data from a previous randomized controlled trial comparing the McKenzie treatment approach with placebo in patients with chronic LBP. Ten baseline prognostic variables were explored in predictive models for three outcomes: pain intensity, disability, and global perceived effect, at 6 and 12 months. Predictive models were created using backward stepwise logistic and linear multivariate regression analyses.  Results : Several predictors were present including age, expectancy of improvement, global perceived effect; however, we only identified baseline disability as a universal predictor of outcomes at 6 months. The second most represented universal predictor was baseline pain intensity for outcomes at 12 months.  Discussion : Only two predictors demonstrated an association with more than one outcome measure. High baseline disability predicts multidimensional outcome measures at 6 months in patients with chronic LBP while baseline pain intensity can best predict the outcome at 12 months. Nevertheless, other predictors seem to be unique to the outcome used. Level of evidence: 2c.",2019,High baseline disability predicts multidimensional outcome measures at 6 months in patients with chronic LBP while baseline pain intensity can best predict the outcome at 12 months.,"['patients with chronic low back pain (LBP', 'patients with chronic low back pain', 'patients with chronic LBP']","['McKenzie', 'placebo']","['baseline pain intensity', 'pain intensity, disability, and global perceived effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.220096,High baseline disability predicts multidimensional outcome measures at 6 months in patients with chronic LBP while baseline pain intensity can best predict the outcome at 12 months.,"[{'ForeName': 'Alessandra Narciso', 'Initials': 'AN', 'LastName': 'Garcia', 'Affiliation': 'a Doctor of Physical Therapy Division, Department of Orthopaedic Surgery, Duke University , Durham , NC , USA.'}, {'ForeName': 'Leonardo O P', 'Initials': 'LOP', 'LastName': 'Costa', 'Affiliation': 'b Physical Therapy, University Cidade de Sao Paulo , Sao Paulo , Brazil.'}, {'ForeName': 'Luciola Da Cunha Menezes', 'Initials': 'LDCM', 'LastName': 'Costa', 'Affiliation': 'd Physical Therapy, Universidade Cidade de São Paulo , Sao Paulo , Brazil.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hancock', 'Affiliation': 'e Discipline of Physiotherapy, Faculty of Human Sciences, Macquarie University , Sydney , Australia.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'f Doctor of Physical Therapy Division, Duke Clinical Research Institute, Duke University , Durham , NC , USA.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2019.1597435']
116,31385620,Voice-Related Quality of Life Increases With a Talking Tracheostomy Tube: A Randomized Controlled Trial.,"OBJECTIVE


The primary objective of our study was to determine the quality of life (QOL) using a talking tracheostomy tube.
METHODS


Randomized clinical trial (NCT2018562). Adult intensive care unit patients who were mechanically ventilated, awake, alert, attempting to communicate, English-speaking, and could not tolerate one-way speaking valve were included. Intervention comprised a Blue Line Ultra Suctionaid (BLUSA) talking tracheostomy tube (Smiths Medical, Dublin, OH, US). Outcome measures included QOL scores measured using Quality of Life in Mechanically Ventilated Patients (QOL-MV) and Voice-Related Quality of Life (V-RQOL), Speech Intelligibility Test (SIT) scores, independence, and satisfaction.
RESULTS


The change in V-RQOL scores from pre- to postintervention was higher among patients using a BLUSA (Smiths Medical) compared to those who did not (P = 0.001). The QOL-MV scores from pre- to postintervention were significantly higher among patients who used a BLUSA (Smiths Medical) compared to patients who did not use BLUSA (Smiths Medical) or a one-way speaking valve (P = 0.04). SIT scores decreased by 6.4 points for each 1-point increase in their Sequential Organ Failure Assessment scores (P = 0.04). The overall QOL-MV scores correlated moderately with the overall V-RQOL scores (correlation coefficient = 0.59). Cronbach alpha score for overall QOL-MV was 0.71. Seventy-three percent of the 22 intervention patients reported the ability to use the BLUSA (Smiths Medical) with some level of independence, whereas 41% reported some level of satisfaction with the use of BLUSA (Smiths Medical). The lengths of stay was longer in the intervention group.
CONCLUSION


Our study suggests that BLUSA (Smiths Medical) talking tracheostomy tube improves patient-reported QOL in mechanically ventilated patients with a tracheostomy who cannot tolerate cuff deflation.
LEVEL OF EVIDENCE


I Laryngoscope, 130:1249-1255, 2020.",2020,The QOL-MV scores from pre- to postintervention were significantly higher among patients who used a BLUSA (Smiths Medical) compared to patients who did not use BLUSA (Smiths Medical) or a one-way speaking valve (P = 0.04).,"['mechanically ventilated patients with a tracheostomy who cannot tolerate cuff deflation', 'Adult intensive care unit patients who were mechanically ventilated, awake, alert, attempting to communicate, English-speaking, and could not tolerate one-way speaking valve were included']","['BLUSA (Smiths Medical) talking tracheostomy tube', 'talking tracheostomy tube', 'Blue Line Ultra Suctionaid (BLUSA) talking tracheostomy tube']","['SIT scores', 'Cronbach alpha score for overall QOL-MV', 'Sequential Organ Failure Assessment scores', 'lengths of stay', 'ability to use the BLUSA', 'QOL-MV scores', 'overall QOL-MV scores', 'quality of life (QOL', 'change in V-RQOL scores', 'QOL scores measured using Quality of Life in Mechanically Ventilated Patients (QOL-MV) and Voice-Related Quality of Life (V-RQOL), Speech Intelligibility Test (SIT) scores, independence, and satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit (environment)'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0566001', 'cui_str': 'Does communicate (finding)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0554249', 'cui_str': 'Smith (occupation)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0184159', 'cui_str': 'Tracheostomy tube'}, {'cui': 'C1260957', 'cui_str': 'Blue color (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3494459', 'cui_str': 'SOFAS Scores'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0725424,The QOL-MV scores from pre- to postintervention were significantly higher among patients who used a BLUSA (Smiths Medical) compared to patients who did not use BLUSA (Smiths Medical) or a one-way speaking valve (P = 0.04).,"[{'ForeName': 'Vinciya', 'Initials': 'V', 'LastName': 'Pandian', 'Affiliation': 'Johns Hopkins School of Nursing, Baltimore, Maryland, U.S.A.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Cole', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, Maryland, U.S.A.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Kilonsky', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, Maryland, U.S.A.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Holden', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, Maryland, U.S.A.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Feller-Kopman', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, Maryland, U.S.A.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Brower', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, Maryland, U.S.A.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Mirski', 'Affiliation': 'The Johns Hopkins Hospital, Baltimore, Maryland, U.S.A.'}]",The Laryngoscope,['10.1002/lary.28211']
117,32006612,Openness Personality Trait Associated With Benefit From a Nonpharmacological Breathlessness Intervention in People With Intrathoracic Cancer: An Exploratory Analysis.,"CONTEXT


Breathlessness is common in people with lung cancer. Nonpharmacological breathlessness interventions reduce distress because of and increase mastery over breathlessness.
OBJECTIVES


Identify patient characteristics associated with response to breathlessness interventions.
METHODS


Exploratory secondary trial data analysis. Response defined as a one-point improvement in 0-10 Numerical Rating Scale of worst breathlessness/last 24 hours (response-worst) or a 0.5-point improvement in the Chronic Respiratory Questionnaire (CRQ) mastery (response-mastery) at four weeks. Univariable regression explored relationships with plausible demographic, clinical, and psychological variables followed by multivariable regression for associated (P < 0.05) variables.
RESULTS


About 158 participants with intrathoracic cancer (mean age 69.4 [SD 9.35] years; 40% women) were randomized to one or three breathlessness training sessions. About 91 participants had evaluable data for response-worst and 107 for response-mastery. In the univariable analyses, the personality trait openness was associated with response-worst (odds ratio [OR] 1.99 [95% CI 1.08-3.67]; P = 0.028) and response-mastery (OR 1.84 [95% CI 1.04-3.23]; P = 0.035). Higher CRQ-fatigue (OR 0.61 [95% CI 0.41-0.91]; P = 0.015), CRQ-emotion (OR 0.68 [95% CI 0.47-0.96]; P = 0.030), and worse CRQ-mastery (OR 0.61 [95% CI 0.42-0.88]; P = 0.008), and the presence of metastases and fatigue were associated with reduced odds of response-mastery. In the adjusted response-mastery model, only openness remained (OR 1.73 [95% CI 0.95-3.15]; P = 0.072).
CONCLUSION


Worse baseline health, worse breathlessness mastery, but not severity, and openness were associated with a better odds of response. Breathlessness services must be easy to access, and patients should be encouraged and supported to attend.",2020,Higher CRQ-Fatigue (OR 0.61 [95% CI 0.41 to 0.91]:,"['people with intra-thoracic cancer', '158 participants with intrathoracic cancer (mean age 69.4 [SD: 9.35] years; 40% women', 'people with lung cancer']",['pharmacological breathlessness intervention'],"['Response-Mastery ', 'Chronic Respiratory Questionnaire (CRQ) Mastery (Response-Mastery', 'Worse baseline health, worse breathlessness mastery', 'Higher CRQ-Fatigue', 'personality trait ""openness', 'worse CRQ-Mastery', 'CRQ-Emotion']","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}]","[{'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0233849', 'cui_str': 'Personality finding'}, {'cui': 'C0547049', 'cui_str': 'Openness (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}]",158.0,0.164625,Higher CRQ-Fatigue (OR 0.61 [95% CI 0.41 to 0.91]:,"[{'ForeName': 'Miriam J', 'Initials': 'MJ', 'LastName': 'Johnson', 'Affiliation': 'Palliative Medicine, Wolfson Palliative Care Research Centre, University of Hull, Hull, UK. Electronic address: miriam.johnson@hyms.ac.uk.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Nabb', 'Affiliation': 'Student Wellbeing Learning and Welfare Support, University of Hull, Hull, UK; Humber Teaching NHS Foundation Trust, Willerby Hill, Hull, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Booth', 'Affiliation': 'Cicely Saunders Institute, University of Cambridge, Kings College London, London, UK.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Kanaan', 'Affiliation': 'Department of Health Sciences, Applied Health Research (Statistics), University of York, York, UK.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.01.006']
118,32311968,Effect of 5 different cervical collars on optic nerve sheath diameter: A randomized crossover trial.,"BACKGROUND


There is considerable evidence that prolonged use of cervical collars potentially cause detrimental effects including increase in optic nerve sheath diameter (ONSD) among healthy volunteers. Different types of cervical collars immobilize cervical spine variably well and may presumably differently influence the venous compression and hence the intracranial pressure. We therefore aimed to evaluate the influence of cervical spine immobilization with 5 different types of cervical collars on ONSD measured noninvasively by ultrasound on healthy volunteers.
METHODS


We conducted a randomized crossover trial including 60 adult healthy volunteers. Control assessment of the optic nerve sheath thickness was performed in both sagittal and transverse planes. Patient was placed supine on a transport stretcher, cervical collar was placed, and ONSD measurement was performed after 5 and 20 minutes. During the next days, the procedure was repeated with random allocation of participants and random cervical collar.
RESULTS


Sixty healthy volunteers were included in our study. ONSD left diameter [mm] for the baseline was 3.8 [interquartile range (IQR): 3.65-3.93)] mm. Using AMBU after 5 min, ONSD was changed up to 4.505 (IQR 4.285-4.61; P < .001) mm. The largest change at 5 minutes and 20 minutes was using Philly 4.73 (IQR: 4.49-4.895; P < .001) and 4.925 (IQR: 4.65-5.06; P < .001), respectively. Necklite reported the lower change in ONSD: 3.92 (IQR: 3.795-4; P = 1.0) mm in 5 minutes and 3.995 (IQR: 3.875 - 4.1; P = 1.0) mm in 20 minutes. ONSD right diameter [mm] for the baseline was 3.8 (IQR 3.675-3.9) mm. Using AMBU after 5 minutes, ONSD was changed up to 4.5 (IQR 4.21-4.6) mm. The largest change at 5 minutes and 20 minutes was using Philly 4.705 (IQR 4.455-4.9) and 4.93 (IQR 4.645-5.075), respectively. Necklite reported the lower change in ONSD -33.9 (IQR 3.795-3.99) mm in 5 minutes and 3.995 (IQR 3.86-4.09) mm in 20 minutes.
CONCLUSION


We report significant increase of ONSD from the baseline after cervical collar placement among healthy volunteers at 5 minutes and 20 minutes interval. In addition, no significant difference was noted between ONSD measurements at 5 and 20 minutes. Clinicians should take proactive steps to assess the actual need of cervical collar case by case basis. Nonetheless, when needed, Necklite moldable neck brace seems to be a reasonable option.Registration: ClinicalTrials database (www.clinicaltrials.gov, NCT03609879).",2020,"The largest change at 5 minutes and 20 minutes was using Philly 4.73 (IQR: 4.49-4.895; P < .001) and 4.925 (IQR: 4.65-5.06; P < .001), respectively.","['healthy volunteers', 'Registration', '60 adult healthy volunteers', 'Sixty healthy volunteers']",['5 different cervical collars'],"['ONSD measurements', 'optic nerve sheath diameter', 'optic nerve sheath thickness', 'ONSD', 'optic nerve sheath diameter (ONSD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0175751', 'cui_str': 'Cervical collar'}]","[{'cui': 'C0228673', 'cui_str': 'Optic nerve sheath structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",60.0,0.277633,"The largest change at 5 minutes and 20 minutes was using Philly 4.73 (IQR: 4.49-4.895; P < .001) and 4.925 (IQR: 4.65-5.06; P < .001), respectively.","[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Ladny', 'Affiliation': 'Department of Trauma-Orthopedic Surgery, Solec Hospital, Warsaw, Poland.'}, {'ForeName': 'Jacek', 'Initials': 'J', 'LastName': 'Smereka', 'Affiliation': 'Department of Emergency Medical Service, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Sanchit', 'Initials': 'S', 'LastName': 'Ahuja', 'Affiliation': 'Department of Anesthesiology, Pain management and Perioperative Medicine, Henry Ford Health System, Detroit, MI.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Szarpak', 'Affiliation': 'Medical Simulation Center, Lazarski University, Warsaw, Poland.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Ruetzler', 'Affiliation': 'Departments of Outcomes Research and General Anesthesiology, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Jerzy Robert', 'Initials': 'JR', 'LastName': 'Ladny', 'Affiliation': 'Clinic of Emergency Medicine, Medical University Bialystok, Bialystok, Poland.'}]",Medicine,['10.1097/MD.0000000000019740']
119,31880632,Ultrasound-Assisted Versus Landmark-Guided Spinal Anesthesia in Patients With Abnormal Spinal Anatomy: A Randomized Controlled Trial.,"BACKGROUND


Spinal anesthesia using a surface landmark-guided technique can be challenging in patients with anatomical alterations of the lumbar spine; however, it is unclear whether using ultrasonography can decrease the technical difficulties in these populations. We assessed whether an ultrasound-assisted technique could reduce the number of needle passes required for block success compared with the landmark-guided technique in patients with abnormal spinal anatomy.
METHODS


Forty-four patients with abnormal spinal anatomy including documented lumbar scoliosis and previous spinal surgery were randomized to receive either surface landmark-guided or preprocedural ultrasound-assisted spinal anesthesia. All spinal procedures were performed by 1 of 3 experienced anesthesiologists. The primary outcome was the number of needle passes required for successful dural puncture. Secondary outcomes included the success rate on the first pass, total procedure time, periprocedural pain scores, and the incidences of radicular pain, paresthesia, and bloody tap during the neuraxial procedure. Intergroup difference in the primary outcome was assessed for significance using Mann-Whitney U test.
RESULTS


The median (interquartile range [IQR; range]) number of needle passes was significantly lower in the ultrasound group than in the landmark group (ultrasound 1.5 [1-3 {1-5}]; landmark 6 [2-9.3 {1-15}]; P < .001). First-pass success was achieved in 11 (50.0%) and 2 (9.1%) patients in the ultrasound and landmark groups, respectively (P = .007). The total procedure time, defined as the sum of the time for identifying landmarks and performing spinal anesthesia, did not differ significantly between the 2 groups (ultrasound 141 seconds [115-181 seconds {101-336 seconds}]; landmark 146 seconds [90-295 seconds {53-404 seconds}]; P = .888). The ultrasound group showed lower periprocedural pain scores compared with the landmark group (ultrasound 3.5 [1-5 {0-7}]; landmark 5.5 [3-8 {0-9}]; P = .012). The incidences of complications during the procedure showed no significant differences between the 2 groups.
CONCLUSIONS


For anesthesiologists with experience in neuraxial ultrasonography, the use of ultrasound significantly reduces the technical difficulties of spinal anesthesia in patients with abnormal spinal anatomy compared with the landmark-guided technique. Our results can lead to practical suggestions that encourage the use of neuraxial ultrasonography for spinal anesthesia in such patients.",2020,The ultrasound group showed lower periprocedural pain scores compared with the landmark group (ultrasound 3.5 [1-5 {0-7}]; landmark 5.5 [3-8 {0-9}]; P = .012).,"['patients with anatomical alterations of the lumbar spine', 'Patients With Abnormal Spinal Anatomy', 'Forty-four patients with abnormal spinal anatomy including documented lumbar scoliosis and previous spinal surgery', 'patients with abnormal spinal anatomy']","['ultrasound-assisted technique', 'Ultrasound-Assisted Versus Landmark-Guided Spinal Anesthesia', 'surface landmark-guided or preprocedural ultrasound-assisted spinal anesthesia', 'neuraxial ultrasonography']","['median (interquartile range [IQR; range]) number of needle passes', 'periprocedural pain scores', 'incidences of complications', 'success rate on the first pass, total procedure time, periprocedural pain scores, and the incidences of radicular pain, paresthesia, and bloody tap during the neuraxial procedure', 'total procedure time, defined as the sum of the time for identifying landmarks and performing spinal anesthesia', 'number of needle passes required for successful dural puncture']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C2748518', 'cui_str': 'Lumbar scoliosis'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444693', 'cui_str': 'First pass (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain (finding)'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0033119', 'cui_str': 'Puncture wound - injury (disorder)'}]",44.0,0.0703103,The ultrasound group showed lower periprocedural pain scores compared with the landmark group (ultrasound 3.5 [1-5 {0-7}]; landmark 5.5 [3-8 {0-9}]; P = .012).,"[{'ForeName': 'Sun-Kyung', 'Initials': 'SK', 'LastName': 'Park', 'Affiliation': 'From the Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Bae', 'Affiliation': ''}, {'ForeName': 'Seokha', 'Initials': 'S', 'LastName': 'Yoo', 'Affiliation': ''}, {'ForeName': 'Won Ho', 'Initials': 'WH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Young-Jin', 'Initials': 'YJ', 'LastName': 'Lim', 'Affiliation': ''}, {'ForeName': 'Jae-Hyon', 'Initials': 'JH', 'LastName': 'Bahk', 'Affiliation': ''}, {'ForeName': 'Jin-Tae', 'Initials': 'JT', 'LastName': 'Kim', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004600']
120,31522843,"Antibiotic or silver versus standard ventriculoperitoneal shunts (BASICS): a multicentre, single-blinded, randomised trial and economic evaluation.","BACKGROUND


Insertion of a ventriculoperitoneal shunt for hydrocephalus is one of the commonest neurosurgical procedures worldwide. Infection of the implanted shunt affects up to 15% of these patients, resulting in prolonged hospital treatment, multiple surgeries, and reduced cognition and quality of life. Our aim was to determine the clinical and cost-effectiveness of antibiotic (rifampicin and clindamycin) or silver shunts compared with standard shunts at reducing infection.
METHODS


In this parallel, multicentre, single-blind, randomised controlled trial, we included patients with hydrocephalus of any aetiology undergoing insertion of their first ventriculoperitoneal shunt irrespective of age at 21 regional adult and paediatric neurosurgery centres in the UK and Ireland. Patients were randomly assigned (1:1:1 in random permuted blocks of three or six) to receive standard shunts (standard shunt group), antibiotic-impregnated (0·15% clindamycin and 0·054% rifampicin; antibiotic shunt group), or silver-impregnated shunts (silver shunt group) through a randomisation sequence generated by an independent statistician. All patients and investigators who recorded and analysed the data were masked for group assignment, which was only disclosed to the neurosurgical staff at the time of operation. Participants receiving a shunt without evidence of infection at the time of insertion were followed up for at least 6 months and a maximum of 2 years. The primary outcome was time to shunt failure due the infection and was analysed with Fine and Gray survival regression models for competing risk by intention to treat. This trial is registered with ISRCTN 49474281.
FINDINGS


Between June 26, 2013, and Oct 9, 2017, we assessed 3505 patients, of whom 1605 aged up to 91 years were randomly assigned to receive either a standard shunt (n=536), an antibiotic-impregnated shunt (n=538), or a silver shunt (n=531). 1594 had a shunt inserted without evidence of infection at the time of insertion (533 in the standard shunt group, 535 in the antibiotic shunt group, and 526 in the silver shunt group) and were followed up for a median of 22 months (IQR 10-24; 53 withdrew from follow-up). 32 (6%) of 533 evaluable patients in the standard shunt group had a shunt revision for infection, compared with 12 (2%) of 535 evaluable patients in the antibiotic shunt group (cause-specific hazard ratio [csHR] 0·38, 97·5% CI 0·18-0·80, p=0·0038) and 31 (6%) of 526 patients in the silver shunt group (0·99, 0·56-1·74, p=0·96). 135 (25%) patients in the standard shunt group, 127 (23%) in the antibiotic shunt group, and 134 (36%) in the silver shunt group had adverse events, which were not life-threatening and were mostly related to valve or catheter function.
INTERPRETATION


The BASICS trial provides evidence to support the adoption of antibiotic shunts in UK patients who are having their first ventriculoperitoneal shunt insertion. This practice will benefit patients of all ages by reducing the risk and harm of shunt infection.
FUNDING


UK National Institute for Health Research Health Technology Assessment programme.",2019,"1594 had a shunt inserted without evidence of infection at the time of insertion (533 in the standard shunt group, 535 in the antibiotic shunt group, and 526 in the silver shunt group) and were followed up for a median of 22 months (IQR 10-24; 53 withdrew from follow-up).","['UK patients who are having their first ventriculoperitoneal shunt insertion', 'Between June 26, 2013, and Oct 9, 2017', 'patients with hydrocephalus of any aetiology undergoing insertion of their first ventriculoperitoneal shunt irrespective of age at 21 regional adult and paediatric neurosurgery centres in the UK and Ireland', '3505 patients, of whom 1605 aged up to 91 years']","['antibiotic-impregnated shunt (n=538), or a silver shunt', 'Antibiotic or silver versus standard ventriculoperitoneal shunts (BASICS', 'antibiotic (rifampicin and clindamycin', 'standard shunt', 'standard shunts (standard shunt group), antibiotic-impregnated (0·15% clindamycin and 0·054% rifampicin; antibiotic shunt group), or silver-impregnated shunts (silver shunt group) through a randomisation sequence generated by an independent statistician', 'silver shunts', 'ventriculoperitoneal shunt']","['specific hazard ratio [csHR', 'shunt revision for infection', 'adverse events', 'time to shunt failure due the infection', 'cognition and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175662', 'cui_str': 'Ventriculoperitoneal shunt device (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0020255', 'cui_str': 'Hydrocephaly'}, {'cui': 'C1314792', 'cui_str': 'Causality'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1442858', 'cui_str': 'Surgical fistula'}, {'cui': 'C0037125', 'cui_str': 'Silver'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0175662', 'cui_str': 'Ventriculoperitoneal shunt device (physical object)'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0334957', 'cui_str': 'Statistician (occupation)'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1442858', 'cui_str': 'Surgical fistula'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0034380'}]",526.0,0.179442,"1594 had a shunt inserted without evidence of infection at the time of insertion (533 in the standard shunt group, 535 in the antibiotic shunt group, and 526 in the silver shunt group) and were followed up for a median of 22 months (IQR 10-24; 53 withdrew from follow-up).","[{'ForeName': 'Conor L', 'Initials': 'CL', 'LastName': 'Mallucci', 'Affiliation': ""Department of Paediatric Neurosurgery, Alder Hey Children's Hospital, Liverpool, UK. Electronic address: cmallucci@me.com.""}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Jenkinson', 'Affiliation': 'Department of Neurosurgery, Walton Centre National Health Service Foundation Trust, Liverpool, UK; Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Conroy', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Hartley', 'Affiliation': ""Department of Microbiology, Great Ormond Street Children's Hospital, London, UK.""}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Dalton', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Kearns', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Moitt', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Griffiths', 'Affiliation': ""Department of Paediatric Neurology, Alder Hey Children's Hospital, Liverpool, UK; Institute of Infection and Global Health, University of Liverpool, Liverpool, UK.""}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Culeddu', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Solomon', 'Affiliation': 'Department of Neurology, Walton Centre National Health Service Foundation Trust, Liverpool, UK; Institute of Infection and Global Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Dyfrig', 'Initials': 'D', 'LastName': 'Hughes', 'Affiliation': 'Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, UK.'}, {'ForeName': 'Carrol', 'Initials': 'C', 'LastName': 'Gamble', 'Affiliation': 'Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)31603-4']
121,30420725,Reduction of personal PM 2.5  exposure via indoor air filtration systems in Detroit: an intervention study.,"The adverse health effects of fine particulate matter (PM < 2.5 μm in diameter [PM 2.5 ]) air pollution are well-documented. There is a growing body of evidence that high-efficiency particulate arrestance (HEPA) filtration can reduce indoor PM 2.5  concentrations and deliver some health benefits via the reduction of exposure to PM. However, few studies have tested the ability of portable air filtration systems to lower overall personal-level PM 2.5  exposures. The Reducing Air Pollution in Detroit Intervention Study (RAPIDS) was designed to evaluate cardiovascular health benefits and personal PM 2.5  exposure reductions via indoor portable air filtration systems among senior citizens in Detroit, Michigan. We evaluated the utility of two commercially available high-efficiency (HE: true-HEPA) and low-efficiency (LE: HEPA-type) indoor air filtration to reduce indoor PM 2.5  concentrations and personal PM 2.5  exposures for 40 participants in a double-blinded randomized crossover intervention. Each participant was subjected to three intervention scenarios: HE, LE, or no filter (control) of three consecutive days each, during which personal, indoor, and outdoor PM 2.5  concentrations were measured daily. For mean indoor PM 2.5  concentrations, we observed 60 and 52% reductions using HE and LE filters, respectively, relative to no filtration. Personal PM 2.5  exposures were reduced by 53 and 31% using HE and LE filters, respectively, when compared with the control scenario. To our knowledge, this is the first indoor air filtration intervention study to examine the effectiveness of both HE and LE filters in reducing personal PM 2.5  exposures.",2019,"Personal PM 2.5  exposures were reduced by 53 and 31% using HE and LE filters, respectively, when compared with the control scenario.","['40 participants', 'Detroit']",['personal PM 2.5  exposure via indoor air filtration systems'],[],[],"[{'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",[],,0.0312513,"Personal PM 2.5  exposures were reduced by 53 and 31% using HE and LE filters, respectively, when compared with the control scenario.","[{'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Maestas', 'Affiliation': 'Exposure Science Lab, Family Medicine, College of Human Medicine, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Rosemary A', 'Initials': 'RA', 'LastName': 'Ziemba', 'Affiliation': 'Community Health Nursing, Ann Arbor, MI, USA.'}, {'ForeName': 'Fengyao', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Exposure Science Lab, Family Medicine, College of Human Medicine, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Crane', 'Affiliation': 'Exposure Science Lab, Family Medicine, College of Human Medicine, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Zachary M', 'Initials': 'ZM', 'LastName': 'Klaver', 'Affiliation': 'Exposure Science Lab, Family Medicine, College of Human Medicine, Michigan State University, East Lansing, MI, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Bard', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Spino', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Sara D', 'Initials': 'SD', 'LastName': 'Adar', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Morishita', 'Affiliation': 'Exposure Science Lab, Family Medicine, College of Human Medicine, Michigan State University, East Lansing, MI, USA. tomoko@msu.edu.'}]",Journal of exposure science & environmental epidemiology,['10.1038/s41370-018-0085-2']
122,31434935,Randomized clinical trial: the effect of probiotic Bacillus coagulans Unique IS2 vs. placebo on the symptoms management of irritable bowel syndrome in adults.,"The therapeutic effects of B. coagulans Unique IS2 have been well established in children with irritable bowel syndrome (IBS), but its efficacy in adults remain under reported. Thus, in this study the efficacy of B. coagulans Unique IS2 in the management of IBS symptoms in adults was investigated. Patients (n = 153) fulfilling Rome III criteria were provided placebo capsules for a 2 weeks run-in period. Only patients satisfying compliance criteria (n = 136) were randomized (double blind) to receive either B. coagulans Unique IS2 (2 billion CFU) or placebo capsules daily for 8 weeks. Reduction of abdominal discomfort/pain intensity and increase in complete spontaneous bowel movements were analyzed as primary end points. Other clinical symptoms of IBS and serum cytokines were also evaluated. B. coagulans Unique IS2 showed significant improvement in primary and secondary endpoints, as compared to placebo. Haematology of both the arms remained normal. No significant changes in pro- (IL-6, IL-12, TNF-α, INF- γ) and anti-inflammatory cytokine (IL-10) levels were detected at the end of B. coagulans treatment (8 weeks) as compared to placebo. B. coagulans was well tolerated with no severe adverse events to report. Overall, the results demonstrate that B. coagulans Unique IS2 is efficacious in the management of IBS symptoms in adults (18-60 years).",2019,"No significant changes in pro- (IL-6, IL-12, TNF-α, INF- γ) and anti-inflammatory cytokine (IL-10) levels were detected at the end of B. coagulans treatment (8 weeks) as compared to placebo.","['irritable bowel syndrome in adults', 'children with irritable bowel syndrome (IBS', 'Only patients satisfying compliance criteria (n\u2009=\u2009136', 'Patients (n\u2009', '153) fulfilling Rome III criteria were provided']","['B. coagulans Unique IS2 (2 billion CFU) or placebo', 'placebo', 'probiotic Bacillus coagulans Unique IS2 vs. placebo']","['complete spontaneous bowel movements', 'Reduction of abdominal discomfort/pain intensity', 'IBS and serum cytokines', 'pro- (IL-6, IL-12, TNF-α, INF- γ) and anti-inflammatory cytokine (IL-10) levels']","[{'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0232487', 'cui_str': 'Abdominal discomfort (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.29664,"No significant changes in pro- (IL-6, IL-12, TNF-α, INF- γ) and anti-inflammatory cytokine (IL-10) levels were detected at the end of B. coagulans treatment (8 weeks) as compared to placebo.","[{'ForeName': 'Ratna Sudha', 'Initials': 'RS', 'LastName': 'Madempudi', 'Affiliation': 'Centre for Research & Development, Unique Biotech Ltd., Plot No. 2, Phase-II, Alexandria Knowledge Park, Hyderabad, Telangana, 500078, India. sudha@uniquebiotech.com.'}, {'ForeName': 'Jayesh J', 'Initials': 'JJ', 'LastName': 'Ahire', 'Affiliation': 'Centre for Research & Development, Unique Biotech Ltd., Plot No. 2, Phase-II, Alexandria Knowledge Park, Hyderabad, Telangana, 500078, India.'}, {'ForeName': 'Jayanthi', 'Initials': 'J', 'LastName': 'Neelamraju', 'Affiliation': 'Centre for Research & Development, Unique Biotech Ltd., Plot No. 2, Phase-II, Alexandria Knowledge Park, Hyderabad, Telangana, 500078, India.'}, {'ForeName': 'Anirudh', 'Initials': 'A', 'LastName': 'Tripathi', 'Affiliation': 'Life Veda Treatment and Research Centre, Worli, Mumbai, 400030, India.'}, {'ForeName': 'Satyavrat', 'Initials': 'S', 'LastName': 'Nanal', 'Affiliation': 'Nanal Clinic, Anand Bhuvan, Gore wadi, Mahim (W), Mumbai, 400016, India.'}]",Scientific reports,['10.1038/s41598-019-48554-x']
123,31439873,Daily high-frequency transcranial random noise stimulation of bilateral temporal cortex in chronic tinnitus - a pilot study.,"Several studies emphasized the potential of single and multiple transcranial random noise stimulation (tRNS) sessions to interfere with auditory cortical activity and to reduce tinnitus loudness. It was the objective of the present study to evaluate the use of high-frequency (hf) tRNS in a one-arm pilot study in patients with chronic tinnitus. Therefore, 30 patients received 10 sessions of high frequency tRNS (100-640 Hz; 2 mA; 20 minutes) over the bilateral temporal cortex. All patients had received rTMS treatment for their tinnitus at least 3 months before tRNS. Primary outcome was treatment response (tinnitus questionnaire reduction of ≥5 points). The trial was registered at clinicaltrials.gov (NCT01965028). Eight patients (27%) responded to tRNS. Exactly the same number of patients had responded before to rTMS, but there were only two ""double responders"" for both treatments. None of the secondary outcomes (tinnitus numeric rating scales, depressivity, and quality of life) was significant when results were corrected for multiple comparisons. tRNS treatment was accompanied by tolerable side effects but resulted in temporal increases in tinnitus loudness in 20% of the cases (2 drop-outs). Our trial showed that hf-tRNS is feasible for daily treatment in chronic tinnitus. However, summarizing low treatment response, increase of tinnitus loudness in 20% of patients and missing of any significant secondary outcome, the use of hf-tRNS as a general treatment for chronic tinnitus cannot be recommended at this stage. Differences in treatment responders between tRNS and rTMS highlight the need for individualized treatment procedures.",2019,"None of the secondary outcomes (tinnitus numeric rating scales, depressivity, and quality of life) was significant when results were corrected for multiple comparisons.","['patients with chronic tinnitus', '30 patients received']","['tRNS', '10 sessions of high frequency tRNS', 'high-frequency (hf) tRNS', 'rTMS', 'Daily high-frequency transcranial random noise stimulation', 'transcranial random noise stimulation (tRNS) sessions']","['secondary outcomes (tinnitus numeric rating scales, depressivity, and quality of life', 'tolerable side effects', 'treatment response (tinnitus questionnaire reduction of ≥5 points', 'tinnitus loudness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0178733', 'cui_str': 'Loudness (finding)'}]",,0.113412,"None of the secondary outcomes (tinnitus numeric rating scales, depressivity, and quality of life) was significant when results were corrected for multiple comparisons.","[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Kreuzer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany. peter.kreuzer@medbo.de.'}, {'ForeName': 'Timm B', 'Initials': 'TB', 'LastName': 'Poeppl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Rupprecht', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Vielsmeier', 'Affiliation': 'Department of Otorhinolaryngology, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Lehner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Langguth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schecklmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany.'}]",Scientific reports,['10.1038/s41598-019-48686-0']
124,31471173,"Alternate Day Fasting Improves Physiological and Molecular Markers of Aging in Healthy, Non-obese Humans.","Caloric restriction and intermittent fasting are known to prolong life- and healthspan in model organisms, while their effects on humans are less well studied. In a randomized controlled trial study (ClinicalTrials.gov identifier: NCT02673515), we show that 4 weeks of strict alternate day fasting (ADF) improved markers of general health in healthy, middle-aged humans while causing a 37% calorie reduction on average. No adverse effects occurred even after >6 months. ADF improved cardiovascular markers, reduced fat mass (particularly the trunk fat), improving the fat-to-lean ratio, and increased β-hydroxybutyrate, even on non-fasting days. On fasting days, the pro-aging amino-acid methionine, among others, was periodically depleted, while polyunsaturated fatty acids were elevated. We found reduced levels sICAM-1 (an age-associated inflammatory marker), low-density lipoprotein, and the metabolic regulator triiodothyronine after long-term ADF. These results shed light on the physiological impact of ADF and supports its safety. ADF could eventually become a clinically relevant intervention.",2019,"ADF improved cardiovascular markers, reduced fat mass (particularly the trunk fat), improving the fat-to-lean ratio, and increased β-hydroxybutyrate, even on non-fasting days.","['Healthy, Non-obese Humans', 'healthy, middle-aged humans while causing a 37% calorie reduction on average']",['strict alternate day fasting (ADF'],"['levels sICAM-1', 'ADF improved cardiovascular markers, reduced fat mass', 'adverse effects']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0558287', 'cui_str': 'Alternate days (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.101099,"ADF improved cardiovascular markers, reduced fat mass (particularly the trunk fat), improving the fat-to-lean ratio, and increased β-hydroxybutyrate, even on non-fasting days.","[{'ForeName': 'Slaven', 'Initials': 'S', 'LastName': 'Stekovic', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria.'}, {'ForeName': 'Sebastian J', 'Initials': 'SJ', 'LastName': 'Hofer', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria; BioTechMed Graz, Graz 8010, Austria.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Tripolt', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Aon', 'Affiliation': 'Experimental Gerontology Section, Translational Gerontology Branch, National Institute on Aging, NIH, Baltimore, MD 21224, USA; Laboratory of Cardiovascular Science, National Institute on Aging, NIH, Baltimore, MD 21224, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Royer', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Pein', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria; Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Julia T', 'Initials': 'JT', 'LastName': 'Stadler', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria; Division of Pharmacology, Otto Loewi Research Center, Medical University of Graz, Universitätsplatz 4, 8010 Graz, Austria.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Pendl', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Prietl', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria; Center for Biomarker Research in Medicine (CBmed), Graz, Austria.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Url', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria; Center for Biomarker Research in Medicine (CBmed), Graz, Austria.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Schroeder', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria; BioTechMed Graz, Graz 8010, Austria.'}, {'ForeName': 'Jelena', 'Initials': 'J', 'LastName': 'Tadic', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Eisenberg', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria; BioTechMed Graz, Graz 8010, Austria; NAWI Graz Central Lab Gracia, NAWI Graz, Graz, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Magnes', 'Affiliation': 'HEALTH Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Forschungsgesellschaft mbH, Neue Stiftingtalstraße 2, Graz, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stumpe', 'Affiliation': 'Department of Biology, University of Fribourg, Chemin du Musée 10, 1700 Fribourg, Switzerland.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Zuegner', 'Affiliation': 'HEALTH Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Forschungsgesellschaft mbH, Neue Stiftingtalstraße 2, Graz, Austria.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Bordag', 'Affiliation': 'HEALTH Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Forschungsgesellschaft mbH, Neue Stiftingtalstraße 2, Graz, Austria.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Riedl', 'Affiliation': 'Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz, Austria.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Schmidt', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Ewald', 'Initials': 'E', 'LastName': 'Kolesnik', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Verheyen', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Medical University of Graz, Austria.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Springer', 'Affiliation': 'Gottfried Schatz Research Center for Cell Signaling, Metabolism and Aging, Molecular Biology and Biochemistry, Medical University of Graz, Neue Stiftingtalstraße 6/, VI 8010 Graz, Austria.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Madl', 'Affiliation': 'BioTechMed Graz, Graz 8010, Austria; Gottfried Schatz Research Center for Cell Signaling, Metabolism and Aging, Molecular Biology and Biochemistry, Medical University of Graz, Neue Stiftingtalstraße 6/, VI 8010 Graz, Austria.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Sinner', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria; HEALTH Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Forschungsgesellschaft mbH, Neue Stiftingtalstraße 2, Graz, Austria.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'de Cabo', 'Affiliation': 'Experimental Gerontology Section, Translational Gerontology Branch, National Institute on Aging, NIH, Baltimore, MD 21224, USA.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Kroemer', 'Affiliation': ""Equipe 11 labellisée par la Ligue contre le Cancer, Centre de Recherche des Cordeliers, Paris, France; Cell Biology and Metabolomics platforms, Gustave Roussy Cancer Campus, Villejuif, France; INSERM U1138, Paris, France; Université Paris Descartes, Sorbonne Paris Cité, Paris, France; Université Pierre et Marie Curie, Paris, France; Pôle de Biologie, Hôpital Européen Georges Pompidou, AP-HP, Paris, France; Karolinska Institute, Department of Women's and Children's Health, Karolinska University Hospital, Stockholm, Sweden; Center of Systems Medicine, Chinese Academy of Science Sciences, Suzhou, China.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Obermayer-Pietsch', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria; Center for Biomarker Research in Medicine (CBmed), Graz, Austria.'}, {'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Dengjel', 'Affiliation': 'Department of Biology, University of Fribourg, Chemin du Musée 10, 1700 Fribourg, Switzerland; Department of Dermatology, Medical Center, University of Freiburg, Hauptstr. 7, 79104 Freiburg, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Sourij', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria; Center for Biomarker Research in Medicine (CBmed), Graz, Austria.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Austria; Center for Biomarker Research in Medicine (CBmed), Graz, Austria; HEALTH Institute for Biomedicine and Health Sciences, JOANNEUM RESEARCH Forschungsgesellschaft mbH, Neue Stiftingtalstraße 2, Graz, Austria.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Madeo', 'Affiliation': 'Institute of Molecular Biosciences, NAWI Graz, University of Graz, Humboldtstraße 50, Graz 8010, Austria; BioTechMed Graz, Graz 8010, Austria. Electronic address: frank.madeo@uni-graz.at.'}]",Cell metabolism,['10.1016/j.cmet.2019.07.016']
125,32325490,"Daratumumab, lenalidomide, bortezomib, and dexamethasone for transplant-eligible newly diagnosed multiple myeloma: the GRIFFIN trial.","Lenalidomide, bortezomib, and dexamethasone (RVd) followed by autologous stem cell transplantation (ASCT) is standard frontline therapy for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM). The addition of daratumumab (D) to RVd (D-RVd) in transplant-eligible NDMM patients was evaluated. Patients (N = 207) were randomized 1:1 to D-RVd or RVd induction (4 cycles), ASCT, D-RVd or RVd consolidation (2 cycles), and lenalidomide or lenalidomide plus D maintenance (26 cycles). The primary end point, stringent complete response (sCR) rate by the end of post-ASCT consolidation, favored D-RVd vs RVd (42.4% vs 32.0%; odds ratio, 1.57; 95% confidence interval, 0.87-2.82; 1-sided P = .068) and met the prespecified 1-sided α of 0.10. With longer follow-up (median, 22.1 months), responses deepened; sCR rates improved for D-RVd vs RVd (62.6% vs 45.4%; P = .0177), as did minimal residual disease (MRD) negativity (10-5 threshold) rates in the intent-to-treat population (51.0% vs 20.4%; P < .0001). Four patients (3.8%) in the D-RVd group and 7 patients (6.8%) in the RVd group progressed; respective 24-month progression-free survival rates were 95.8% and 89.8%. Grade 3/4 hematologic adverse events were more common with D-RVd. More infections occurred with D-RVd, but grade 3/4 infection rates were similar. Median CD34+ cell yield was 8.2 × 106/kg for D-RVd and 9.4 × 106/kg for RVd, although plerixafor use was more common with D-RVd. Median times to neutrophil and platelet engraftment were comparable. Daratumumab with RVd induction and consolidation improved depth of response in patients with transplant-eligible NDMM, with no new safety concerns. This trial was registered at www.clinicaltrials.gov as #NCT02874742.",2020,There was no difference in median times to neutrophil or platelet engraftment.,"['ASCT-eligible NDMM patients', 'patients with transplant-eligible NDMM', 'Patients (N=207', 'Transplant-eligible Newly Diagnosed Multiple Myeloma', 'transplant-eligible patients with newly diagnosed multiple myeloma (NDMM']","['RVd ±D induction (4 cycles), ASCT, RVd ±D consolidation (2 cycles), and lenalidomide ±D maintenance', 'Lenalidomide, bortezomib, and dexamethasone (RVd) followed by autologous stem cell transplantation (ASCT', 'Daratumumab, Lenalidomide, Bortezomib, & Dexamethasone', 'plerixafor']","['median times to neutrophil or platelet engraftment', 'stringent complete response (sCR) rate', 'Median CD34+ cell yield', 'depth of response', '24-month progression-free survival rates', 'Grade 3/4 hematologic adverse events', 'minimal residual disease negativity']","[{'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1955474', 'cui_str': 'Plerixafor'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0882849', 'cui_str': 'Cell positive for CD34 antigen'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}]",207.0,0.136648,There was no difference in median times to neutrophil or platelet engraftment.,"[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, NC.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Laubach', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Sborov', 'Affiliation': 'Huntsman Cancer Institute, School of Medicine, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Brandi', 'Initials': 'B', 'LastName': 'Reeves', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Hematology and Oncology, School of Medicine, Wake Forest University, Winston-Salem, NC.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Silbermann', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Luciano J', 'Initials': 'LJ', 'LastName': 'Costa', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Larry D', 'Initials': 'LD', 'LastName': 'Anderson', 'Affiliation': 'Simmons Comprehensive Cancer Center, UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Nitya', 'Initials': 'N', 'LastName': 'Nathwani', 'Affiliation': 'Judy and Bernard Briskin Center for Multiple Myeloma Research, City of Hope Comprehensive Cancer Center, Duarte, CA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Yvonne A', 'Initials': 'YA', 'LastName': 'Efebera', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Holstein', 'Affiliation': 'Division of Oncology & Hematology, University of Nebraska Medical Center, Omaha, NE.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Costello', 'Affiliation': 'Moores Cancer Center, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Jakubowiak', 'Affiliation': 'University of Chicago Medical Center, Chicago, IL.'}, {'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Wildes', 'Affiliation': 'Section of Medical Oncology, Division of Oncology, School of Medicine, Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'Department of Lymphoma-Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Shain', 'Affiliation': 'Department of Malignant Hematology, H. Lee Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Cowan', 'Affiliation': 'Division of Medical Oncology, University of Washington, Seattle, WA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA.'}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Lutska', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA.'}, {'ForeName': 'Huiling', 'Initials': 'H', 'LastName': 'Pei', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, NJ.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Medical Affairs, Horsham, PA; and.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vermeulen', 'Affiliation': 'Janssen Research & Development, LLC, Leiden, The Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'de Boer', 'Affiliation': 'Janssen Research & Development, LLC, Leiden, The Netherlands.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hoehn', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Lin', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}]",Blood,['10.1182/blood.2020005288']
126,31439877,Feasibility of conducting an active exercise prehabilitation program in patients awaiting spinal stenosis surgery: a randomized pilot study.,"Prehabilitation is defined as the process of augmenting functional capacity before surgery in preparation for the postoperative phase. This study intends to assess the feasibility of conducting a preoperative intervention program in patients with lumbar spinal stenosis and to report on the piloting of the proposed intervention. Patients were allocated to a 6-week supervised preoperative rehabilitation program or a control group. The intervention included supervised exercise sessions aimed to improve strength, muscular endurance, and spinal stabilization. Outcomes were measured at baseline, 6 weeks later and again 6 weeks, 3 months and 6 months after surgery. Sixty-five percent of admissible participants agreed to take part in the study, of which 5% dropped out before the end of the intervention period. Eighty-eight percent of potential training sessions were delivered without adverse event. Improvements were seen in favour of the experimental group at the preoperative assessment for active ranges of motion, leg pain intensity, lumbar extensor muscle endurance and walking capacities. Results show that slight modifications to the choice of outcome measures would increase feasibility of the main study. The absence of adverse events coupled with positive changes seen in dependant outcome measures warrant the conduct of a full-scale trial assessing the effectiveness of the intervention.",2019,"Improvements were seen in favour of the experimental group at the preoperative assessment for active ranges of motion, leg pain intensity, lumbar extensor muscle endurance and walking capacities.","['patients awaiting spinal stenosis surgery', 'patients with lumbar spinal stenosis']","['active exercise prehabilitation program', 'supervised preoperative rehabilitation program or a control group', 'supervised exercise sessions aimed to improve strength, muscular endurance, and spinal stabilization', 'preoperative intervention program']","['active ranges of motion, leg pain intensity, lumbar extensor muscle endurance and walking capacities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037944', 'cui_str': 'Spinal Stenosis'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region (disorder)'}]","[{'cui': 'C0419117', 'cui_str': 'Active exercise (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]",,0.0270679,"Improvements were seen in favour of the experimental group at the preoperative assessment for active ranges of motion, leg pain intensity, lumbar extensor muscle endurance and walking capacities.","[{'ForeName': 'Andrée-Anne', 'Initials': 'AA', 'LastName': 'Marchand', 'Affiliation': 'Department of Anatomy, Université du Québec à Trois-Rivières, Trois-Rivières, Canada. andree-anne.marchand@uqtr.ca.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Suitner', 'Affiliation': 'Department of Human Kinetics, Université du Québec à Trois-Rivières, Trois-Rivières, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Department of Chiropractic, Université du Québec à Trois-Rivières, Trois-Rivières, Canada.'}, {'ForeName': 'Claude-Édouard', 'Initials': 'CÉ', 'LastName': 'Châtillon', 'Affiliation': 'Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec, Trois-Rivières, Canada.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cantin', 'Affiliation': 'Department of Human Kinetics, Université du Québec à Trois-Rivières, Trois-Rivières, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Descarreaux', 'Affiliation': 'Department of Human Kinetics, Université du Québec à Trois-Rivières, Trois-Rivières, Canada.'}]",Scientific reports,['10.1038/s41598-019-48736-7']
127,31444365,The Effect of Critical Shoulder Angle on Clinical Scores and Retear Risk After Rotator Cuff Tendon Repair at Short-term Follow Up.,"The authors aimed to investigate whether standard acromioplasty can reduce critical shoulder angle (CSA) effectively and to investigate the effects of postoperative CSA on the clinical outcomes and retear rates. Patients are divided in to three groups: group 1 (24 patients): CSA under 35° before surgery, group 2 (25 patients): CSA over 35° before surgery and under 35° after surgery and group 3 (17 patients): CSA over 35° before and after surgery. Standard acromioplasty was performed if CSA is over 35 and no acromioplasty was performed if the CSA is already under 35. Preoperative and postoperative CSAs, UCLA, Constant-Murley clinical score and visual analog scale (VAS) pain score were measured. The size of the rotator cuff tear was classified by the Patte classification in preoperative MRI and the quality of the repair was evaluated as retear if discontinuity detected in the postoperative first year MRI. There were 31 female and 35 male patients with a mean age of 59.3 ± 4.5 years (range, 48-68) at the time of surgery. The mean CSA is reduced from 37.8° ± 1.4 to 34.9° ± 1.2 (p < 0.001) significantly for patients who underwent acromioplasty. In 25 (59.5%) of the 42 patients, the CSA was reduced to under 35°, whereas in the other 17 (40.5%) patients, it remained over 35°. The mean Constant and UCLA score was 46.4 ± 6.6; 18.5 ± 1.6 preoperatively and 82.4 ± 6.2; 31.1 ± 1.9 postoperatively respectively (p < 0,001). The mean VAS decreased from 4.94 ± 1.09 to 0.79 ± 0.71 (p < 0.001). No Clinical difference was seen between patients in which CSA could be reduced under 35° or not in terms of Constant-Murley score, UCLA and VAS score. Retear was observed in 2 (8.3%) patients in group 1, in 4 (16%) patients in group 2 and in 3 patients (17.6%) in group 3. There was not any significant difference between the patients who had retear or not in terms of neither the CSA values nor the change of CSA after the surgery. Standard acromioplasty, which consists of an anterolateral acromial resection, can reduce CSA by approximately 3°. This is not always sufficient to decrease the CSAs to the favorable range of 30°-35°. In addition, its effect on clinical outcomes does not seem to be noteworthy.",2019,There was not any significant difference between the patients who had retear or not in terms of neither the CSA values nor the change of CSA after the surgery.,"['31 female and 35 male patients with a mean age of 59.3\u2009±\u20094.5\xa0years (range, 48-68) at the time of surgery']","['standard acromioplasty', 'CSA']","['mean VAS', 'CSA', 'Clinical Scores and Retear Risk', 'mean CSA', 'size of the rotator cuff tear', 'Preoperative and postoperative CSAs, UCLA, Constant-Murley clinical score and visual analog scale (VAS) pain score', 'mean Constant and UCLA score', 'Constant-Murley score, UCLA and VAS score']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0186663', 'cui_str': 'Repair of acromion (procedure)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0263912', 'cui_str': 'Rotator Cuff Tears'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}]",31.0,0.0479033,There was not any significant difference between the patients who had retear or not in terms of neither the CSA values nor the change of CSA after the surgery.,"[{'ForeName': 'Tahsin', 'Initials': 'T', 'LastName': 'Gürpınar', 'Affiliation': 'Istanbul Training and Resarch Hospital, Department of Orthopaedics and Traumatology, Istanbul, Turkey.'}, {'ForeName': 'Barış', 'Initials': 'B', 'LastName': 'Polat', 'Affiliation': 'University of Kyrenia, Department of Orthopaedic and Traumatology, Kyrenia, Turkish Republic of North, Cyprus. drbpolat@hotmail.com.'}, {'ForeName': 'Engin', 'Initials': 'E', 'LastName': 'Çarkçı', 'Affiliation': 'Istanbul Training and Resarch Hospital, Department of Orthopaedics and Traumatology, Istanbul, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Eren', 'Affiliation': 'Istanbul Training and Resarch Hospital, Department of Orthopaedics and Traumatology, Istanbul, Turkey.'}, {'ForeName': 'Ayşe Esin', 'Initials': 'AE', 'LastName': 'Polat', 'Affiliation': 'Dr. Akçiçek State Hospital, Department of Orthopedics and Traumatology, Kyrenia, Turkish Republic of North, Cyprus.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Öztürkmen', 'Affiliation': 'Istanbul Training and Resarch Hospital, Department of Orthopaedics and Traumatology, Istanbul, Turkey.'}]",Scientific reports,['10.1038/s41598-019-48644-w']
128,31444404,Low-molecular-weight-heparin increases Th1- and Th17-associated chemokine levels during pregnancy in women with unexplained recurrent pregnancy loss: a randomised controlled trial.,"Low-molecular-weight heparin (LMWH) is widely used to treat recurrent pregnancy loss (RPL) because of its anti-coagulant effects. Although in vitro studies have suggested additional immunological effects, these are debated. We therefore investigated whether LMWH could modulate immune responses in vivo during pregnancy of women with unexplained RPL. A Swedish open multi-centre randomised controlled trial included 45 women treated with tinzaparin and 42 untreated women. Longitudinally collected plasma samples were obtained at gestational weeks (gw) 6, 18, 28 and 34 and analysed by multiplex bead technology for levels of 11 cytokines and chemokines, chosen to represent inflammation and T-helper subset-associated immunity. Mixed linear models test on LMWH-treated and untreated women showed differences during pregnancy of the Th1-associated chemokines CXCL10 (p = 0.01), CXCL11 (p < 0.001) and the Th17-associated chemokine CCL20 (p = 0.04), while CCL2, CCL17, CCL22, CXCL1, CXCL8, CXCL12, CXCL13 and IL-6 did not differ. Subsequent Student's t-test showed significantly higher plasma levels of CXCL10 and CXCL11 in treated than untreated women at gw 28 and 34. The consistent increase in the two Th1-associated chemokines suggests a potential proinflammatory and unfavourable effect of LMWH treatment during later stages of pregnancy, when Th1 immunity is known to disrupt immunological tolerance.",2019,Subsequent Student's t-test showed significantly higher plasma levels of CXCL10 and CXCL11 in treated than untreated women at gw 28 and 34.,"['women with unexplained RPL', '45 women treated with', 'women with unexplained recurrent pregnancy loss', 'and 42 untreated women']","['LMWH', 'tinzaparin', 'Low-molecular-weight heparin (LMWH']","['Th17-associated chemokine CCL20', 'CCL2, CCL17, CCL22, CXCL1, CXCL8, CXCL12, CXCL13', 'CXCL11', 'plasma levels of CXCL10 and CXCL11']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2921106', 'cui_str': 'Recurrent pregnancy loss'}]","[{'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0216278', 'cui_str': 'tinzaparin'}]","[{'cui': 'C1961104', 'cui_str': 'Small Inducible Cytokine A20'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",45.0,0.211614,Subsequent Student's t-test showed significantly higher plasma levels of CXCL10 and CXCL11 in treated than untreated women at gw 28 and 34.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rasmark Roepke', 'Affiliation': 'Department of Obstetrics and Gynecology, Skåne University Hospital, Malmö and Lund University, Lund, Sweden. emma_36@hotmail.com.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Bruno', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nedstrand', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Boij', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'C Petersson', 'Initials': 'CP', 'LastName': 'Strid', 'Affiliation': 'Departmen of Obstetrics and Gynecology, Kalmar Hospital, Kalmar, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Piccione', 'Affiliation': 'Section of Gynecology and Obstetrics, Academic Department of Biomedicine and Prevention, and Clinical Department of Surgery, Tor Vergata University Hospital, Rome, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Berg', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Svensson-Arvelund', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Jenmalm', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rubér', 'Affiliation': 'Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ernerudh', 'Affiliation': 'Department of Clinical Immunology and Transfusion Medicine, and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.'}]",Scientific reports,['10.1038/s41598-019-48799-6']
129,32279030,Effects of using high-intensity interval training and calorie restriction in different orders on metabolic syndrome: A randomized controlled trial.,"OBJECTIVE


Studies of the effectiveness of high-intensity interval training (HIIT) combined with calorie restriction (CR) are very limited, and the most effective order of intervention is unclear. Therefore, we investigated the impact of time-efficient HIIT with CR intervention on metabolic syndrome (MetS) and the impact of the intervention order on changes in MetS risk factors.
METHODS


Thirty-two participants with MetS underwent an 11-wk intervention program comprising 8 wk of HIIT and 3 wk of CR. Participants were randomly assigned to either the HIIT-then-CR or CR-then-HIIT groups. Thereafter, the CR-then-HIIT group performed a further 8 wk of training once per week after the initial intervention period. Risk factors for MetS and peak oxygen uptake (VO 2peak ) were assessed during the entire study period.
RESULTS


During the 11-wk intervention period, body composition, MetS risk factors, and VO2 peak  significantly improved in both groups. No significant differences in these improvements were attributable to the intervention order; nonetheless, there was a tendency toward larger effect sizes in the CR-then-HIIT group. During the postintervention period (8 wk), a single weekly HIIT session prevented VO 2peak  reduction in the CR-then-HIIT group (-2.0 ± 7.2%; P = 0.31).
CONCLUSIONS


The time-efficient intervention program with HIIT and CR had a beneficial effect on MetS; however, the intervention order had no influence on the changes in risk factors.",2020,"No significant differences in these improvements were attributable to the intervention order; nonetheless, there was a tendency toward larger effect sizes in the CR-then-HIIT group.","['Thirty-two participants with MetS underwent an 11-wk intervention program comprising 8 wk of HIIT and 3 wk of CR', 'metabolic syndrome']","['high-intensity interval training (HIIT) combined with calorie restriction (CR', 'high-intensity interval training and calorie restriction', 'CR intervention']","['body composition, MetS risk factors, and VO2 peak', 'Risk factors for MetS and peak oxygen uptake (VO 2peak ', 'metabolic syndrome (MetS']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",32.0,0.0341696,"No significant differences in these improvements were attributable to the intervention order; nonetheless, there was a tendency toward larger effect sizes in the CR-then-HIIT group.","[{'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'So', 'Affiliation': 'Occupational Epidemiology Research Group, National Institute of Occupational Safety and Health, Japan. Kwasaki, Japan; Research Center for Overwork-Related Disorders, National Institute of Occupational Safety and Health, Japan. Kawasaki, Japan. Electronic address: sorina@crf-res.net.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Matsuo', 'Affiliation': 'Occupational Epidemiology Research Group, National Institute of Occupational Safety and Health, Japan. Kwasaki, Japan; Research Center for Overwork-Related Disorders, National Institute of Occupational Safety and Health, Japan. Kawasaki, Japan.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2019.110666']
130,32326806,"Effects of Glucagon-Like Peptide-1 Receptor Agonists, Sodium-Glucose Cotransporter-2 Inhibitors, and Their Combination on Endothelial Glycocalyx, Arterial Function, and Myocardial Work Index in Patients With Type 2 Diabetes Mellitus After 12-Month Treatment.","Background We investigated the effects of insulin, glucagon-like peptide-1 receptor agonists (GLP-1RA), sodium-glucose cotransporter-2 inhibitors (SGLT-2i), and their combination on vascular and cardiac function of patients with type 2 diabetes mellitus. Methods and Results A total of 160 patients with type 2 diabetes mellitus were randomized to insulin (n=40), liraglutide (n=40), empagliflozin (n=40), or their combination (GLP-1RA+SGLT-2i) (n=40) as add-on to metformin. We measured at baseline and 4 and 12 months posttreatment: (a) perfused boundary region of the sublingual arterial microvessels (marker of endothelial glycocalyx thickness), (b) pulse wave velocity (PWV) and central systolic blood pressure, (c) global left ventricular longitudinal, circumferential, and radial strain, (d) myocardial work index (global work index) derived by pressure-myocardial strain loops using speckle tracking imaging. Twelve months posttreatment, all patients improved perfused boundary region, PWV, global longitudinal strain, global circumferential strain, and global radial strain ( P <0.05). GLP-1RA, SGLT-2i, and their combination showed a greater reduction of perfused boundary region, PWV, and central systolic blood pressure than insulin, despite a similar glycosylated hemoglobin reduction ( P <0.05). GLP-1RA or GLP-1RA+SGLT-2i provided a greater increase of global work index (12.7% and 17.4%) compared with insulin or SGLT-2i (3.1% and 2%). SGLT-2i or GLP-1RA and SGLT-2i showed a greater decrease of PWV (10.1% and 13%) and central and brachial systolic blood pressure than insulin or GLP-1RA (PWV, 3.6% and 8.6%) ( P <0.05 for all comparisons). The dual therapy showed the greatest effect on measured markers in patients with left ventricular ejection fraction <55% ( P <0.05). Conclusions Twelve-month treatment with GLP-1RA, SGLT-2i, and their combination showed a greater improvement of vascular markers and effective cardiac work than insulin treatment in type 2 diabetes mellitus. The combined therapy as second line was superior to either insulin or GLP-1RA and SGLT-2i separately. Registration URL: https://www.clini​caltr​ials.gov. Unique identifier: NCT03878706.",2020,GLP-1RA or GLP-1RA+SGLT-2i provided a greater increase of global work index (12.7% and 17.4%) compared with insulin or SGLT-2i (3.1% and 2%).,"['160 patients with type 2 diabetes mellitus', 'Patients With Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus']","['liraglutide', 'Glucagon-Like Peptide-1 Receptor Agonists, Sodium-Glucose Cotransporter-2 Inhibitors', 'empagliflozin (n=40), or their combination (GLP-1RA+SGLT-2i) (n=40) as add-on to metformin', 'GLP-1RA or GLP-1RA+SGLT-2i', 'insulin, glucagon-like peptide-1 receptor agonists (GLP-1RA), sodium-glucose cotransporter-2 inhibitors (SGLT-2i', 'insulin']","['PWV', 'sublingual arterial microvessels (marker of endothelial glycocalyx thickness), (b) pulse wave velocity (PWV) and central systolic blood pressure, (c) global left ventricular longitudinal, circumferential, and radial strain, (d) myocardial work index (global work index) derived by pressure-myocardial strain loops using speckle tracking imaging', 'Endothelial Glycocalyx, Arterial Function, and Myocardial Work Index', 'central and brachial systolic blood pressure', 'perfused boundary region, PWV, global longitudinal strain, global circumferential strain, and global radial strain', 'global work index', 'glycosylated hemoglobin reduction', 'vascular markers and effective cardiac work', 'perfused boundary region, PWV, and central systolic blood pressure']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0378073', 'cui_str': 'GLP-1R Receptor'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C2350570', 'cui_str': 'Microvessels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1868749', 'cui_str': 'Myocardial strain'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",160.0,0.0509528,GLP-1RA or GLP-1RA+SGLT-2i provided a greater increase of global work index (12.7% and 17.4%) compared with insulin or SGLT-2i (3.1% and 2%).,"[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': '2nd Department of Cardiology Laboratory of Preventive Cardiology and Echocardiography Department Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Pavlidis', 'Affiliation': '2nd Department of Internal Medicine Research Unit and Diabetes Centre Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thymis', 'Affiliation': '2nd Department of Cardiology Laboratory of Preventive Cardiology and Echocardiography Department Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Dionysia', 'Initials': 'D', 'LastName': 'Birba', 'Affiliation': '2nd Department of Cardiology Laboratory of Preventive Cardiology and Echocardiography Department Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Aimilianos', 'Initials': 'A', 'LastName': 'Kalogeris', 'Affiliation': '2nd Department of Cardiology Laboratory of Preventive Cardiology and Echocardiography Department Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Foteini', 'Initials': 'F', 'LastName': 'Kousathana', 'Affiliation': '2nd Department of Internal Medicine Research Unit and Diabetes Centre Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Kountouri', 'Affiliation': '2nd Department of Internal Medicine Research Unit and Diabetes Centre Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Balampanis', 'Affiliation': '2nd Department of Internal Medicine Research Unit and Diabetes Centre Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Parissis', 'Affiliation': '2nd Department of Cardiology Laboratory of Preventive Cardiology and Echocardiography Department Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Laboratory of Pharmacology Faculty of Pharmacy National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Katogiannis', 'Affiliation': '2nd Department of Cardiology Laboratory of Preventive Cardiology and Echocardiography Department Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dimitriadis', 'Affiliation': '2nd Department of Internal Medicine Research Unit and Diabetes Centre Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Aristotelis', 'Initials': 'A', 'LastName': 'Bamias', 'Affiliation': '2nd Department of Internal Medicine Research Unit and Diabetes Centre Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Iliodromitis', 'Affiliation': '2nd Department of Cardiology Laboratory of Preventive Cardiology and Echocardiography Department Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': '2nd Department of Internal Medicine Research Unit and Diabetes Centre Attikon Hospital Medical School National and Kapodistrian University of Athens Athens Greece.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015716']
131,32281113,Comparison of proximal and distal corticosteroid injections for carpal tunnel syndrome.,"INTRODUCTION


Evidence for the efficacy of distal corticosteroid injection compared with proximal injection in carpal tunnel syndrome (CTS) is inadequate.
METHODS


We conducted a randomized, double-blind noninferiority trial of 131 wrists with CTS. Forty milligrams of methylprednisolone was injected medial to the palmaris longus tendon 2 cm proximal to the wrist crease, or at the volar aspect, 2 to 3 cm distal to the wrist crease. Proximal & distal groups received a placebo. The primary outcome was difference in CTS Symptom Severity Scale (SSS) score at 1 month. Secondary outcome measures included the difference in SSS score at 3 months, Functional Status Scale (FSS) score at 1 and 3 months, and pain of injections.
RESULTS


No significant differences were noted between groups in scores on the SSS and FSS. Pain was lower in the proximal group compared with the distal group.
DISCUSSION


Corticosteroid injections for CTS distal to the wrist are not inferior to proximal injections, yet they are more painful.",2020,"Pain was lower in the proximal than distal group Discussion Corticosteroid injections for CTS distal to the wrist are not inferior to proximal injections, but are more painful.","['131 wrists with CTS', 'carpal tunnel syndrome']","['methylprednisolone', 'placebo', 'proximal and distal corticosteroid injections', 'proximal injection', 'distal corticosteroid injection']","['CTS symptom severity scale (SSS', 'difference in SSS at 3 months, functional status scale (FSS', 'Pain', 'pain of injections']","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",131.0,0.175168,"Pain was lower in the proximal than distal group Discussion Corticosteroid injections for CTS distal to the wrist are not inferior to proximal injections, but are more painful.","[{'ForeName': 'Pradeep Pankajakshan', 'Initials': 'PP', 'LastName': 'Nair', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Vaibhav', 'Initials': 'V', 'LastName': 'Wadwekar', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Sunitha Vellathussery', 'Initials': 'SV', 'LastName': 'Chakkalakkoombil', 'Affiliation': 'Department of Radiodiagnosis, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Sunil K', 'Initials': 'SK', 'LastName': 'Narayan', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Revanth', 'Initials': 'R', 'LastName': 'Marusani', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Murgai', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Sibi', 'Initials': 'S', 'LastName': 'Thirunavukkarasu', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Amritha', 'Initials': 'A', 'LastName': 'Krishnamoorthy', 'Affiliation': 'Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}, {'ForeName': 'Harichandrakumar Kottyen', 'Initials': 'HK', 'LastName': 'Thazhath', 'Affiliation': 'Department of Medical Biometrics and Informatics, Jawaharlal Institute of Postgraduate Medical Education, Pondicherry, India.'}]",Muscle & nerve,['10.1002/mus.26886']
132,31855716,Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial.,"For decades, physicians have administered corticosteroids in the perioperative period to infants undergoing heart surgery with cardiopulmonary bypass (CPB) to reduce the postoperative systemic inflammatory response to CPB. Some question this practice because steroid efficacy has not been conclusively demonstrated and because some studies indicate that steroids could have harmful effects. STRESS is a randomized, placebo-controlled, double-blind, multicenter trial designed to evaluate safety and efficacy of perioperative steroids in infants (age < 1 year) undergoing heart surgery with CPB. Participants (planned enrollment = 1,200) are randomized 1:1 to methylprednisolone (30 mg/kg) administered into the CPB pump prime versus placebo. The trial is nested within the existing infrastructure of the Society of Thoracic Surgeons Congenital Heart Surgery Database. The primary outcome is a global rank score of mortality, major morbidities, and hospital length of stay with components ranked commensurate with their clinical severity. Secondary outcomes include several measures of major postoperative morbidity, postoperative hospital length of stay, and steroid-related safety outcomes including prevalence of hyperglycemia and postoperative infectious complications. STRESS will be one of the largest trials ever conducted in children with heart disease and will answer a decades-old question related to safety and efficacy of perioperative steroids in infants undergoing heart surgery with CPB. The pragmatic ""trial within a registry"" design may provide a mechanism for conducting low-cost, high-efficiency trials in a heretofore-understudied patient population.",2020,"Secondary outcomes include several measures of major postoperative morbidity, postoperative hospital length of stay, and steroid-related safety outcomes including prevalence of hyperglycemia and postoperative infectious complications.","['infants undergoing heart surgery with CPB', 'infants (age <\u202f1\u202fyear) undergoing heart surgery with CPB', 'children with heart disease', 'Participants (planned enrollment\u202f=\u202f1,200', 'infants undergoing heart surgery with cardiopulmonary bypass (CPB']","['methylprednisolone', 'placebo', 'CPB pump prime versus placebo', 'corticosteroids', 'perioperative steroids']","['several measures of major postoperative morbidity, postoperative hospital length of stay, and steroid-related safety outcomes including prevalence of hyperglycemia and postoperative infectious complications', 'safety and efficacy', 'global rank score of mortality, major morbidities, and hospital length of stay with components ranked commensurate with their clinical severity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",1200.0,0.537948,"Secondary outcomes include several measures of major postoperative morbidity, postoperative hospital length of stay, and steroid-related safety outcomes including prevalence of hyperglycemia and postoperative infectious complications.","[{'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC; Duke Clinical Research Institute, Durham, NC. Electronic address: kevin.hill@duke.edu.'}, {'ForeName': 'H Scott', 'Initials': 'HS', 'LastName': 'Baldwin', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Bichel', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Butts', 'Affiliation': 'University of Texas Southwestern, Dallas, TX.'}, {'ForeName': 'Reid C', 'Initials': 'RC', 'LastName': 'Chamberlain', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Alicia M', 'Initials': 'AM', 'LastName': 'Ellis', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Eric M', 'Initials': 'EM', 'LastName': 'Graham', 'Affiliation': 'Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Hickerson', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Jacobs', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Marshall L', 'Initials': 'ML', 'LastName': 'Jacobs', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Robert Db', 'Initials': 'RD', 'LastName': 'Jaquiss', 'Affiliation': 'University of Texas Southwestern, Dallas, TX.'}, {'ForeName': 'Prince J', 'Initials': 'PJ', 'LastName': 'Kannankeril', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Torok', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Turek', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Duke University Pediatric and Congenital Heart Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2019.11.016']
133,32329435,"An exploratory analysis of the association of circadian rhythm dysregulation and insomnia with suicidal ideation over the course of treatment in individuals with depression, insomnia, and suicidal ideation.","STUDY OBJECTIVES


Sleep disturbance is significantly associated with suicidal ideation. However, the majority of past research has examined the relationship between insomnia and suicidality. The current exploratory study examined the relationship of circadian rhythm dysregulation (eveningness, seasonality, and rhythmicity) with suicidality.
METHODS


We examined the association of insomnia, eveningness, seasonality, and rhythmicity with suicidal ideation in 103 participants with depression, insomnia, and suicidality within a larger 8-week double-blinded randomized control trial primarily examining whether cautious use of zolpidem extended-release or placebo reduced suicidal ideation. All participants additionally received an open-label selective serotonin reuptake inhibitor. Methodological strengths of the current analyses included consideration of multiple sleep-wake constructs, adjustment for relevant covariates, investigation of relationships over the course of treatment, and use of both self-report measures and objective measurement with actigraphy.
RESULTS


Over the course of treatment, self-reported eveningness and greater insomnia severity were independently correlated with greater suicidal ideation, whereas actigraphic delayed sleep timing was related to suicidal ideation at a trend level. At the end of treatment, those with greater suicidal ideation demonstrated lower actigraphic activity levels. There were no significant relationships between self-reported seasonality and actigraphic measures of sleep disturbance and suicidality.
CONCLUSIONS


Self-reported delays in sleep timing, objectively lower activity levels, and self-reported insomnia severity correlated independently with greater suicidal ideation in those with depression, insomnia, and suicidality. These exploratory findings highlight the need to consider sleep-wake constructs more broadly in those with suicidality in future research studies in order to improve more definitively both assessment and intervention efforts.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: Reducing Suicidal Ideation through Insomnia Treatment; URL: https://clinicaltrials.gov/ct2/show/NCT01689909; Identifier: NCT01689909 Rumble ME, McCall MV, Dickson DA, Krystal AD, Rosenquist PB, Benca RM. An exploratory analysis of the association of circadian rhythm dysregulation and insomnia with suicidal ideation over the course of treatment in individuals with depression, insomnia, and suicidal ideation. J Clin Sleep Med. 2020;16(8):XXX-XXX.",2020,"There were no significant relationships between self-reported seasonality and actigraphic measures of sleep disturbance and suicidality.
","['103 participants with depression, insomnia, and suicidality within a larger 8-week double', 'individuals with depression, insomnia and suicidal ideation']","['open-label selective serotonin reuptake inhibitor (SSRI', 'zolpidem extended-release (ER) or placebo']","['actigraphic activity levels', 'circadian rhythm dysregulation and insomnia with suicidal ideation', 'insomnia severity', 'suicidal ideation', 'sleep timing, objectively lower activity levels, and self-reported insomnia severity', 'seasonality and actigraphic measures of sleep disturbance and suicidality']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008810', 'cui_str': 'Circadian rhythm'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]",103.0,0.029635,"There were no significant relationships between self-reported seasonality and actigraphic measures of sleep disturbance and suicidality.
","[{'ForeName': 'Meredith E', 'Initials': 'ME', 'LastName': 'Rumble', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'Medical College of Georgia, Augusta, Georgia.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Dickson', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krystal', 'Affiliation': 'University of California, San Francisco, California.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': 'Medical College of Georgia, Augusta, Georgia.'}, {'ForeName': 'Ruth M', 'Initials': 'RM', 'LastName': 'Benca', 'Affiliation': 'University of Wisconsin, Madison, Wisconsin.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8508']
134,32329437,Tailored Approach to Sleep Health Education (TASHE): a randomized controlled trial of a web-based application.,"STUDY OBJECTIVES


In a randomized controlled trial, we compared the effect of the Tailored Approach to Sleep Health Education (TASHE) on obstructive sleep apnea (OSA) self-efficacy among community-dwelling blacks in New York City.
METHODS


Study participants were 194 blacks at high risk for OSA based on the Apnea Risk Evaluation System. TASHE intervention was delivered via a Wi-Fi-enabled tablet, programmed to provide online access to culturally and linguistically tailored information designed to address unique barriers to OSA care among blacks. Blacks in the attention-controlled arm received standard sleep information via the National Sleep Foundation website. Blacks in both arms accessed online sleep information for 2 months. Outcomes (OSA health literacy, self-efficacy, knowledge and beliefs, and sleep hygiene) were assessed at baseline, at 2 months, and at 6 months.
RESULTS


We compared outcomes in both arms based on intention-to-treat analysis using adjusted Generalized Linear Mixed Modeling. TASHE exposure significantly increased OSA self-efficacy (OSA outcome expectation [β = .5; 95% CI: .1-.9] and OSA treatment efficacy [β = 0.4; 95% CI: .0-.8]) at 2 months but not at 6 months. Additionally, TASHE exposure improved sleep hygiene at 6 months (β = 6.7; 95% CI: 2.2-11.3) but not at 2 months.
CONCLUSIONS


Community-dwelling blacks exposed to TASHE materials reported increased OSA self-efficacy compared with standard sleep health education. Stakeholder-engaged, theory-based approaches, as demonstrated in the TASHE intervention, can be used successfully to deliver effective sleep health messages.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; URL: https://clinicaltrials.gov/ct2/show/NCT02507089; Identifier: NCT02507089.",2020,"TASHE exposure significantly increased OSA self-efficacy (OSA outcome expectation [ß = 0.5, 95% CI: 0.1-0.9] and OSA treatment efficacy [ß = 0.4, 95% CI: 0.0-0.8]) at 2 months, but not at 6 months.","['community-dwelling blacks in New York City', 'Study participants were 194 blacks at high risk for OSA based on the Apnea Risk Evaluation System']","['TASHE intervention', 'Tailored Approach to Sleep Health Education (TASHE', 'TASHE']","['sleep hygiene', 'OSA self-efficacy', 'OSA self-efficacy (OSA outcome expectation', 'Outcomes (OSA health literacy, self-efficacy, knowledge and beliefs and sleep hygiene', 'OSA treatment efficacy', 'obstructive sleep apnea (OSA) self-efficacy']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",194.0,0.0756764,"TASHE exposure significantly increased OSA self-efficacy (OSA outcome expectation [ß = 0.5, 95% CI: 0.1-0.9] and OSA treatment efficacy [ß = 0.4, 95% CI: 0.0-0.8]) at 2 months, but not at 6 months.","[{'ForeName': 'Girardin', 'Initials': 'G', 'LastName': 'Jean-Louis', 'Affiliation': 'Department of Population Health, Center for Healthful Behavioral Change, NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Robbins', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Natasha J', 'Initials': 'NJ', 'LastName': 'Williams', 'Affiliation': 'Department of Population Health, Center for Healthful Behavioral Change, NYU Grossman School of Medicine, New York, New York.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Allegrante', 'Affiliation': 'Columbia University Teachers College, New York, New York.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Rapoport', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Alwyn', 'Initials': 'A', 'LastName': 'Cohall', 'Affiliation': 'Columbia University Mailman School of Public Health, New York, New York.'}, {'ForeName': 'Gbenga', 'Initials': 'G', 'LastName': 'Ogedegbe', 'Affiliation': 'Department of Population Health, Center for Healthful Behavioral Change, NYU Grossman School of Medicine, New York, New York.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8510']
135,32229541,Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial.,"RATIONALE


Pulmonary rehabilitation (PR) is an effective, key standard treatment for people with COPD. Nevertheless, low participant uptake, insufficient attendance and high drop-out rates are reported. Investigation is warranted of the benefits achieved through alternative approaches, such as pulmonary tele-rehabilitation (PTR).
OBJECTIVE


To investigate whether PTR is superior to conventional PR on 6 min walk distance (6MWD) and secondarily on respiratory symptoms, quality of life, physical activity and lower limb muscle function in patients with COPD and FEV 1  <50% eligible for routine hospital-based, outpatient PR.
METHODS


In this single-blinded, multicentre, superiority randomised controlled trial, patients were assigned 1:1 to 10 weeks of groups-based PTR (60 min, three times weekly) or conventional PR (90 min, two times weekly). Assessments were performed by blinded assessors at baseline, end of intervention and at 22 weeks' follow-up from baseline. The primary analysis was based on the intention-to-treat principle.
MEASUREMENTS AND MAIN RESULTS


The primary outcome was change in 6MWD from baseline to 10 weeks; 134 participants (74 females, mean±SD age 68±9 years, FEV 1  33%±9% predicted, 6MWD 327±103 metres) were included and randomised. The analysis showed no between-group differences for changes in 6MWD after intervention (9.2 metres (95% CI: -6.6 to 24.9)) or at 22 weeks' follow-up (-5.3 metres (95% CI: -28.9 to 18.3)). More participants completed the PTR intervention (n=57) than conventional PR (n=43) (χ 2  test p<0.01).
CONCLUSION


PTR was not superior to conventional PR on the 6MWD and we found no differences between groups. As more participants completed PTR, supervised PTR would be relevant to compare with conventional PR in a non-inferiority design.  Trial registration number  ClinicalTrials.gov (NCT02667171), 28 January 2016.",2020,PTR was not superior to conventional PR on the 6MWD and we found no differences between groups.,"['134 participants (74 females, mean±SD\u2009age 68±9 years, FEV 1  33%±9% predicted, 6MWD 327±103 metres', 'severe COPD', 'people with COPD', 'patients with COPD and FEV 1  <50% eligible for routine hospital-based, outpatient PR']","['PTR intervention', 'conventional PR', 'Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation', 'PTR']","['change in 6MWD', 'respiratory symptoms, quality of life, physical activity and lower limb muscle function', '6MWD']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0034380'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}]",,0.234033,PTR was not superior to conventional PR on the 6MWD and we found no differences between groups.,"[{'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Hansen', 'Affiliation': 'Respiratory Research Unit, Department of Respiratory Medicine, Hvidovre Hospital, Hvidovre, Denmark henrik.hansen.09@regionh.dk.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Bieler', 'Affiliation': 'Department of Physical and Occupational Therapy, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Beyer', 'Affiliation': 'Institute for Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kallemose', 'Affiliation': 'Clinical Research Center, Copenhagen University Hospital Amager and Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Jon Torgny', 'Initials': 'JT', 'LastName': 'Wilcke', 'Affiliation': 'Department of Pulmonary Medicine, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Lisbeth Marie', 'Initials': 'LM', 'LastName': 'Østergaard', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Frost Andeassen', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Martinez', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lavesen', 'Affiliation': 'Department of Respiratory Medicine and Infectious Diseases, Hillerød Hospital, Hillerød, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Frølich', 'Affiliation': 'Department of Public Health, University of Copenhagen Faculty of Health Sciences, Copenhagen, Denmark.'}, {'ForeName': 'Nina Skavlan', 'Initials': 'NS', 'LastName': 'Godtfredsen', 'Affiliation': 'Institute for Clinical Medicine, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.'}]",Thorax,['10.1136/thoraxjnl-2019-214246']
136,32289634,Effect of genetic factors on the response to vitamin D 3  supplementation in the VIDARIS randomized controlled trial.,"OBJECTIVES


Supplementation provides the best means of improving vitamin D status; however, individual responses vary partly owing to genetics. The aim of this study was to determine whether 28 single nucleotide polymorphisms (SNPs) in six key vitamin D pathway genes (GC, DHCR7, CYP2 R1, CYP24 A1, CYP27 B1, VDR) were associated with differences in response to supplementation.
METHODS


Participants (N = 313; n = 160 vitamin D, n = 153 placebo) were part of VIDARIS (Vitamin D and Acute Respiratory Infections Study), a double-blind, randomized controlled trial involving oral monthly supplementation of either vitamin D 3  (200 000 IU each for the first 2 mo, thereafter 100 000 IU monthly) or placebo for 18 mo. Circulating 25-hydroxyvitamin D (25[OH]D) concentrations at baseline and 2, 6, 12, and 18 mo, and vitamin D binding protein (Gc-globulin) and calculated free 25(OH)D concentrations at baseline and 2 mo were obtained. Multiple regression was used to model associations between genetic variants and 25(OH)D, Gc-globulin, and free 25(OH)D concentrations.
RESULTS


SNPs within GC, CYP2 R1, and CYP27 B1 were associated with 25(OH)D concentrations following supplementation. However, only two GC gene SNPs (rs2282679, rs1155563) were significant after adjustment for multiple testing. This effect disappeared after more than 2 mo of supplementation. None of the SNPs were significantly associated with Gc-globulin concentrations; however, there was a significant interaction with one SNP in DHCR7 (rs12785878), which was associated with reduced free 25(OH)D concentrations in the supplemented arm.
CONCLUSION


Only variants of GC were associated with 25(OH)D concentrations after supplementation. This effect was modest and disappeared after >2 mo of supplementation, suggesting it may be time/dose-dependent and saturable.",2020,"None of the SNPs were significantly associated with Gc-globulin concentrations; however, there was a significant interaction with one SNP in DHCR7","['Participants (N\xa0=\xa0313; n\xa0=\xa0160', '28 single nucleotide polymorphisms (SNPs']","['DHCR7', 'vitamin D 3', 'placebo', 'vitamin D, n\xa0=\xa0153 placebo', 'vitamin D 3  supplementation']","['Circulating 25-hydroxyvitamin D (25[OH]D) concentrations', '25(OH)D concentrations', 'free 25(OH)D concentrations', 'vitamin D binding protein (Gc-globulin) and calculated free 25(OH)D concentrations']","[{'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0042872', 'cui_str': 'GC globulin'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}]",,0.374094,"None of the SNPs were significantly associated with Gc-globulin concentrations; however, there was a significant interaction with one SNP in DHCR7","[{'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Slow', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand. Electronic address: sandy.slow@otago.ac.nz.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Pearson', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Florkowski', 'Affiliation': 'Clinical Biochemistry Unit, Canterbury Health Laboratories, Christchurch, New Zealand.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Elder', 'Affiliation': 'Steroid Unit, Canterbury Health Laboratories, Christchurch, New Zealand.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Lewis', 'Affiliation': 'Steroid Unit, Canterbury Health Laboratories, Christchurch, New Zealand.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Kennedy', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Murdoch', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110761']
137,31427628,Regular exercise improves asthma control in adults: A randomized controlled trial.,"We conducted a randomized controlled trial to test the hypothesis that a 24-week exercise intervention improves asthma control in adults. Adults with mild or moderate asthma were randomly assigned to either the exercise intervention group (IG) or the reference group (RG). Participants in IG received an individualized exercising program, including aerobic exercise at least three times a week for ≥30 minutes, muscle training, and stretching. The primary outcome was asthma control, measured by Asthma Control Test (ACT), asthma-related symptoms, and peak expiratory flow (PEF) variability. We estimated the risk (i.e. probability) of improvement in asthma control and the risk difference (RD) between IG and RG. Of 131 subjects (67 IG/64 RG) entered, 105 subjects (51/54) completed the trial (80%), and 89 (44/45) were analysed (68%). The ACT became better among 26 (62%) participants in IG and among 17 (39%) participants in RG. The effect of intervention on improving asthma control was 23% (RD = 0.23, 95% CI 0.027-0.438; P = 0.0320). The intervention also reduced shortness of breath by 30.1% (RD = 0.301, 95% CI 0.109-0.492; P = 0.003). The change in PEF variability was similar in both groups. Regular exercise improves asthma control measured by the ACT, while has little effect on PEF variability.",2019,"The intervention also reduced shortness of breath by 30.1% (RD = 0.301, 95% CI 0.109-0.492; P = 0.003).","['131 subjects (67 IG/64 RG) entered, 105 subjects (51/54) completed the trial (80%), and 89 (44/45) were analysed (68', 'adults', 'Adults with mild or moderate asthma', 'asthma control in adults']","['exercise intervention group (IG) or the reference group (RG', 'exercise intervention', 'Regular exercise', 'individualized exercising program, including aerobic exercise at least three times a week for ≥30\u2009minutes, muscle training, and stretching']","['PEF variability', 'asthma control', 'shortness of breath', 'asthma control, measured by Asthma Control Test (ACT), asthma-related symptoms, and peak expiratory flow (PEF) variability']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test (assessment scale)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}]",131.0,0.115275,"The intervention also reduced shortness of breath by 30.1% (RD = 0.301, 95% CI 0.109-0.492; P = 0.003).","[{'ForeName': 'Jouni J K', 'Initials': 'JJK', 'LastName': 'Jaakkola', 'Affiliation': 'Center for Environmental and Respiratory Health Research (CERH), University of Oulu, Oulu, Finland. jouni.jaakkola@oulu.fi.'}, {'ForeName': 'Sirpa A M', 'Initials': 'SAM', 'LastName': 'Aalto', 'Affiliation': 'Center for Environmental and Respiratory Health Research (CERH), University of Oulu, Oulu, Finland.'}, {'ForeName': 'Samu', 'Initials': 'S', 'LastName': 'Hernberg', 'Affiliation': 'Center for Environmental and Respiratory Health Research (CERH), University of Oulu, Oulu, Finland.'}, {'ForeName': 'Simo-Pekka', 'Initials': 'SP', 'LastName': 'Kiihamäki', 'Affiliation': 'Center for Environmental and Respiratory Health Research (CERH), University of Oulu, Oulu, Finland.'}, {'ForeName': 'Maritta S', 'Initials': 'MS', 'LastName': 'Jaakkola', 'Affiliation': 'Center for Environmental and Respiratory Health Research (CERH), University of Oulu, Oulu, Finland.'}]",Scientific reports,['10.1038/s41598-019-48484-8']
138,31427637,Statin treatment after acute coronary syndrome: Adherence and reasons for non-adherence in a randomized controlled intervention trial.,"Studies of secondary prevention for cardiovascular disease show low fulfilment of guideline-recommended targets. This study explored whether nurse-led follow-up could increase adherence to statins over time and reasons for discontinuation. All patients admitted for acute coronary syndrome at Östersund hospital between 2010-2014 were screened for the randomized controlled NAILED-ACS trial. The trial comprises two groups, one with nurse-led annual follow-up and medical titration by telephone to reach set intervention targets and one with usual care. All discontinuations of statins were recorded prospectively for at least 36 months and categorized as avoidable or unavoidable. Kaplan-Meier estimates were conducted for first and permanent discontinuations. Predictors for discontinuation were analysed using multivariate Cox regression, statin type and mean LDL-C at end of follow-up. Female gender was a predictor for discontinuation. Allocation in the intervention group predicted increased risk for a first but decreased risk for permanent discontinuation. A nurse-led telemedical secondary prevention programme in a relatively unselected ACS cohort leads to increased adherence to statins over time, greater percentage on potent treatment and lower LDL-C compared to usual care. An initially increased tendency toward early discontinuation in the intervention group stresses the importance of a longer duration of structured follow-up.",2019,"A nurse-led telemedical secondary prevention programme in a relatively unselected ACS cohort leads to increased adherence to statins over time, greater percentage on potent treatment and lower LDL-C compared to usual care.","['after acute coronary syndrome', 'All patients admitted for acute coronary syndrome at Östersund hospital between 2010-2014 were screened for the randomized controlled NAILED-ACS trial']","['Statin treatment', 'nurse-led annual follow-up and medical titration by telephone to reach set intervention targets and one with usual care']",[],"[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0027342', 'cui_str': 'Nails'}]","[{'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0036849', 'cui_str': 'Set'}]",[],2014.0,0.0324895,"A nurse-led telemedical secondary prevention programme in a relatively unselected ACS cohort leads to increased adherence to statins over time, greater percentage on potent treatment and lower LDL-C compared to usual care.","[{'ForeName': 'Huber', 'Initials': 'H', 'LastName': 'Daniel', 'Affiliation': 'Department of Public Health and Clinical Medicine, Unit of Research, Education and Development - Östersund, Umeå University, Östersund, Sweden. daniel.huber@regionjh.se.'}, {'ForeName': 'Wikén', 'Initials': 'W', 'LastName': 'Christian', 'Affiliation': 'Department of Public Health and Clinical Medicine, Unit of Research, Education and Development - Östersund, Umeå University, Östersund, Sweden.'}, {'ForeName': 'Henriksson', 'Initials': 'H', 'LastName': 'Robin', 'Affiliation': 'Department of Public Health and Clinical Medicine, Unit of Research, Education and Development - Östersund, Umeå University, Östersund, Sweden.'}, {'ForeName': 'Söderström', 'Initials': 'S', 'LastName': 'Lars', 'Affiliation': 'Unit of Research, Development and Education, Region Jämtland Härjedalen, Östersund Hospital, Östersund, Sweden.'}, {'ForeName': 'Mooe', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Department of Public Health and Clinical Medicine, Unit of Research, Education and Development - Östersund, Umeå University, Östersund, Sweden.'}]",Scientific reports,['10.1038/s41598-019-48540-3']
139,31537010,"The developing gut-lung axis: postnatal growth restriction, intestinal dysbiosis, and pulmonary hypertension in a rodent model.","BACKGROUND


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


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


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


PNGR causes intestinal dysbiosis and PH. Treatment with DSM 17938 prevents PNGR-associated RVH and PH. Changes in the developing intestine and intestinal microbiota impact the developing lung vasculature and RV.",2020,DSM 17938 treatment decreased α-diversity.,"['Pups were randomized at birth to', 'premature infants increases risk of pulmonary hypertension (PH']","['room air or 75% oxygen (hyperoxia), to normal milk intake (10 pups/dam) or PNGR', 'probiotic Lactobacillus reuteri DSM 17938 or phosphate-buffered saline', 'DSM', 'Postnatal growth restriction (PNGR']","['PNGR-associated RVH and PH', 'PH severity', 'echocardiography and right ventricular hypertrophy (RVH', 'small bowel and cecum', 'α-diversity', 'microbiota of the distal small bowel and cecum']","[{'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0556180', 'cui_str': 'Milk intake (observable entity)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0243109', 'cui_str': 'postnatal growth'}]","[{'cui': 'C0162770', 'cui_str': 'Right Ventricular Hypertrophy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0007531', 'cui_str': 'Cecum'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}]",,0.025137,DSM 17938 treatment decreased α-diversity.,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Wedgwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Cris', 'Initials': 'C', 'LastName': 'Warford', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Sharleen R', 'Initials': 'SR', 'LastName': 'Agvatisiri', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Phung N', 'Initials': 'PN', 'LastName': 'Thai', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Nipavan', 'Initials': 'N', 'LastName': 'Chiamvimonvat', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Kalanetra', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Robin H', 'Initials': 'RH', 'LastName': 'Steinhorn', 'Affiliation': ""Department of Hospitalist Medicine, Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Mills', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA. munderwood@ucdavis.edu.'}]",Pediatric research,['10.1038/s41390-019-0578-2']
140,31427651,Comparison of the effects of an ERAS program and a single-port laparoscopic surgery on postoperative outcomes of colon cancer patients.,"Advancement of the surgical modality and perioperative care are the two main dimensions for the modern improvement of surgical outcome. The purpose of this study was to compare the effectiveness of the two by using the data from the single-port laparoscopic surgery and the early recovery after surgery (ERAS) program. Patients who underwent elective surgery for primary adenocarcinoma of the colon were divided into three groups and compared: ERAS (multi-port laparoscopic surgery with ERAS perioperative care), Conventional-SILS (single-port surgery with conventional perioperative care), or Conventional-Multi (multi-port laparoscopic surgery with conventional perioperative care). Ninety-one, 83, and 96 patients were registered, respectively. There were no differences among the three groups in baseline characteristics except pathological stage and operation site in colon. Although the ERAS group started a soft diet earlier and had earlier discharge, there were no differences in intra- and post-operative morbidity rate, readmission rate, or reoperation rate. The ERAS perioperative care was a significant factor for reducing length of hospital stay in the multivariate analysis, while single-port surgery was not. In modern laparoscopic colon cancer treatment, a systemic approach such as the ERAS program appears to be more effective than a technical approach for significantly improving short-term surgical outcomes.",2019,There were no differences among the three groups in baseline characteristics except pathological stage and operation site in colon.,"['colon cancer patients', 'Patients who underwent elective surgery for primary adenocarcinoma of the colon', 'Ninety-one, 83, and 96 patients were registered, respectively']","['ERAS (multi-port laparoscopic surgery with ERAS perioperative care), Conventional-SILS (single-port surgery with conventional perioperative care), or Conventional-Multi (multi-port laparoscopic surgery with conventional perioperative care', 'single-port laparoscopic surgery and the early recovery after surgery (ERAS) program', 'ERAS program and a single-port laparoscopic surgery', 'ERAS']","['length of hospital stay', 'intra- and post-operative morbidity rate, readmission rate, or reoperation rate']","[{'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0150706', 'cui_str': 'Perioperative Care'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0333873', 'cui_str': 'Squamous intraepithelial lesion'}, {'cui': 'C4087354', 'cui_str': 'Single-port surgery'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}]",,0.0338537,There were no differences among the three groups in baseline characteristics except pathological stage and operation site in colon.,"[{'ForeName': 'Min Ki', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Myongji Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'Jun-Gi', 'Initials': 'JG', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Gyeora', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Daeyoun David', 'Initials': 'DD', 'LastName': 'Won', 'Affiliation': ""Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Yoon Suk', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Bong-Hyeon', 'Initials': 'BH', 'LastName': 'Kye', 'Affiliation': ""Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Jihoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ""Department of Surgery, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'In Kyu', 'Initials': 'IK', 'LastName': 'Lee', 'Affiliation': ""Department of Surgery, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. cmcgslee@catholic.ac.kr.""}]",Scientific reports,['10.1038/s41598-019-48526-1']
141,31427654,Whole-body cryotherapy does not augment adaptations to high-intensity interval training.,"The aim of this study was to investigate the effects of regular post-exercise whole-body cryotherapy (WBC) on physiological and performance adaptations to high-intensity interval training (HIT). In a two-group parallel design, twenty-two well-trained males performed four weeks of cycling HIT, with each session immediately followed by 3 min of WBC (-110 °C) or a passive control (CON). To assess the effects of WBC on the adaptive response to HIT, participants performed the following cycling tests before and after the training period; a graded exercise test (GXT), a time-to-exhaustion test (T max ), a 20-km time trial (20 TT ), and a 120-min submaximal test (SM 120 ). Blood samples were taken before and after training to measure changes in basal adrenal hormones (adrenaline, noradrenaline, and cortisol). Sleep patterns were also assessed during training via wrist actigraphy. As compared with CON, the administration of WBC after each training session during four weeks of HIT had no effect on peak oxygen uptake ([Formula: see text]O 2peak ) and peak aerobic power (P peak ) achieved during the GXT, T max  duration and work performed (W Tmax ), 20 TT  performance, substrate oxidation during the SM 120 , basal adrenaline/noradrenaline/cortisol concentrations, or sleep patterns (P > 0.05). These findings suggest that regular post-exercise WBC is not an effective strategy to augment training-induced aerobic adaptations to four weeks of HIT.",2019,"As compared with CON, the administration of WBC after each training session during four weeks of HIT had no effect on peak oxygen uptake ([Formula: see text]O 2peak ) and peak aerobic power (P peak ) achieved during the GXT, T max  duration and work performed (W Tmax ), 20 TT  performance, substrate oxidation during the SM 120 , basal adrenaline/noradrenaline/cortisol concentrations, or sleep patterns (P > 0.05).",[],"['passive control (CON', 'graded exercise test (GXT', 'CON', 'WBC', 'regular post-exercise whole-body cryotherapy (WBC']","['peak oxygen uptake ([Formula: see text]O 2peak ) and peak aerobic power (P peak ) achieved during the GXT, T max  duration and work performed (W Tmax ), 20 TT  performance, substrate oxidation during the SM 120 , basal adrenaline/noradrenaline/cortisol concentrations, or sleep patterns', 'Sleep patterns', 'basal adrenal hormones (adrenaline, noradrenaline, and cortisol']",[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0474396', 'cui_str': 'Sleep pattern finding'}]",22.0,0.0260345,"As compared with CON, the administration of WBC after each training session during four weeks of HIT had no effect on peak oxygen uptake ([Formula: see text]O 2peak ) and peak aerobic power (P peak ) achieved during the GXT, T max  duration and work performed (W Tmax ), 20 TT  performance, substrate oxidation during the SM 120 , basal adrenaline/noradrenaline/cortisol concentrations, or sleep patterns (P > 0.05).","[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Broatch', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, Australia. james.broatch@vu.edu.au.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Poignard', 'Affiliation': 'French Institute of Sport (INSEP), Research Department, Laboratory Sport, Expertise and Performance, Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Hausswirth', 'Affiliation': ""Université Côte d'Azur, LAMHESS, Nice, France.""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bishop', 'Affiliation': 'Institute for Health and Sport (IHES), Victoria University, Melbourne, Australia.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Bieuzen', 'Affiliation': 'Institut National du Sport du Québec, Montréal, Canada.'}]",Scientific reports,['10.1038/s41598-019-48518-1']
142,31427745,"Efficacy of TIMOLOL nasal spray as a treatment for epistaxis in hereditary hemorrhagic telangiectasia. A double-blind, randomized, placebo-controlled trial.","Hereditary hemorrhagic telangiectasia is a rare vascular genetic disease. Epistaxis is the most frequent and disabling manifestation, and timolol appears to be a new therapeutic option as non-selective beta-blockers have in vitro and in vivo anti-angiogenic properties. Our main objective was to evaluate the efficacy of TIMOLOL nasal spray as a treatment for epistaxis in hereditary hemorrhagic telangiectasia. This study is a single-center, randomized, phase 2, double-blind placebo-controlled study with an allocation ratio of 1:1. It was proposed to patients with hereditary hemorrhagic telangiectasia monitored at the French Reference Center, and we included patients aged over 18 years, diagnosed with hereditary hemorrhagic telangiectasia and epistaxis. The treatment was self-administered by the patient with a posology of one spray (50 µL) of timolol 0.5% or placebo in each nostril twice a day for 28 consecutive days. The primary efficacy endpoint was mean monthly epistaxis duration, assessed by monitoring epistaxis grids. A total of 58 patients were randomized and treated. The baseline characteristics were similar in the 2 groups. Mean monthly epistaxis duration measured at 3 months was not significantly different in the 26 patients receiving the drug in comparison with the placebo group (p = 0.54). Toxicity was low and no severe adverse events were reported. One limitation is that we included all HHT patients with nosebleeds and did not take into account history of nasal surgery or nasal crusts. Timolol, administered by nasal spray at a dose of 0.25 mg in each nostril twice a day for 28 consecutive days, did not improve epistaxis in patients with hereditary hemorrhagic telangiectasia at 4 months after the beginning of the treatment.",2019,Mean monthly epistaxis duration measured at 3 months was not significantly different in the 26 patients receiving the drug in comparison with the placebo group (p = 0.54).,"['HHT patients with nosebleeds and did not take into account history of nasal surgery or nasal crusts', 'epistaxis in hereditary hemorrhagic telangiectasia', 'patients with hereditary hemorrhagic telangiectasia monitored at the French Reference Center, and we included patients aged over 18 years, diagnosed with hereditary hemorrhagic telangiectasia and epistaxis', '58 patients']","['Timolol', 'placebo', 'timolol 0.5% or placebo', 'TIMOLOL nasal spray']","['mean monthly epistaxis duration, assessed by monitoring epistaxis grids', 'severe adverse events', 'Mean monthly epistaxis duration', 'Toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0188970', 'cui_str': 'Rhinosurgery'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0392749', 'cui_str': 'Crusted (qualifier value)'}, {'cui': 'C0039445', 'cui_str': 'Osler-Rendu-Weber Disease'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",58.0,0.265997,Mean monthly epistaxis duration measured at 3 months was not significantly different in the 26 patients receiving the drug in comparison with the placebo group (p = 0.54).,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Dupuis-Girod', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Femme-Mère-Enfants, Service de Génétique et centre de référence pour la maladie de Rendu-Osler, Bron, F-69677, France. sophie.dupuis-girod@chu-lyon.fr.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Pitiot', 'Affiliation': ""Hospices Civils de Lyon, Hôpital E. Herriot, Service d'ORL, Lyon, F-69437, France.""}, {'ForeName': 'Cyrille', 'Initials': 'C', 'LastName': 'Bergerot', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Louis Pradel, Service de cardiologie, Lyon, F-69677, France.'}, {'ForeName': 'Anne-Emmanuelle', 'Initials': 'AE', 'LastName': 'Fargeton', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Femme-Mère-Enfants, Service de Génétique et centre de référence pour la maladie de Rendu-Osler, Bron, F-69677, France.'}, {'ForeName': 'Marjolaine', 'Initials': 'M', 'LastName': 'Beaudoin', 'Affiliation': 'Hospices Civils de Lyon, Hôpital Femme-Mère-Enfants, Service de Génétique et centre de référence pour la maladie de Rendu-Osler, Bron, F-69677, France.'}, {'ForeName': 'Evelyne', 'Initials': 'E', 'LastName': 'Decullier', 'Affiliation': 'Hospices Civils de Lyon, pôle Santé Publique, Lyon, F-69003, France.'}, {'ForeName': 'Valentine', 'Initials': 'V', 'LastName': 'Bréant', 'Affiliation': 'Hospices Civils de Lyon, Pharmacie, Hôpital Louis Pradel, Bron, F-69677, France.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Colombet', 'Affiliation': 'Hospices Civils de Lyon, Pharmacie, Hôpital Louis Pradel, Bron, F-69677, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Philouze', 'Affiliation': ""Hospices Civils de Lyon, Hôpital de la Croix Rousse, Service d'ORL, Lyon, F-69317, France.""}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Faure', 'Affiliation': ""Hospices Civils de Lyon, Hôpital E. Herriot, Service d'ORL, Lyon, F-69437, France.""}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Letievant', 'Affiliation': ""Hospices Civils de Lyon, Hôpital E. Herriot, Service d'ORL, Lyon, F-69437, France.""}]",Scientific reports,['10.1038/s41598-019-48502-9']
143,31666688,"Inhaled nitric oxide as an adjunct to neonatal resuscitation in premature infants: a pilot, double blind, randomized controlled trial.","BACKGROUND


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


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


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


Administration of iNO as an adjunct during neonatal resuscitation is feasible without side effects. It diminishes exposure to high levels of supplemental oxygen.",2020,Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group.,"['premature infants', 'preterm infants requiring positive pressure ventilation (PPV', ""Infants 25 0/7-31 6/7 weeks' gestational age requiring PPV with supplemental oxygen during resuscitation were enrolled""]","['placebo', 'inhaled NO (iNO', 'Inhaled nitric oxide', 'oxygen (FiO 2 -0.30)\u2009+\u2009iNO at 20\u2009ppm (iNO group) or oxygen (FiO 2 -0.30)\u2009+\u2009nitrogen (placebo']","['mean gestational age', 'heart rate (HR), oxygen saturation (SpO 2 ), and need for intubation', 'Cumulative FiO 2  and rate of exposure to high FiO 2', 'HR, SpO 2 , and need for intubation']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.552969,Cumulative FiO 2  and rate of exposure to high FiO 2  (>0.60) were significantly lower in the iNO group.,"[{'ForeName': 'Krishnamurthy', 'Initials': 'K', 'LastName': 'Sekar', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. Kris-Sekar@ouhsc.edu.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Szyld', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCoy', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wlodaver', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Dannaway', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Helmbrecht', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Julee', 'Initials': 'J', 'LastName': 'Riley', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Manfredo', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis Health, Sacramento, CA, USA.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Noori', 'Affiliation': ""Fetal and Neonatal Institute, Division of Neonatology, Children's Hospital of Los Angeles, Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.""}]",Pediatric research,['10.1038/s41390-019-0643-x']
144,31427669,The Effect of Mindfulness Meditation on Impulsivity and its Neurobiological Correlates in Healthy Adults.,"Interest has grown in using mindfulness meditation to treat conditions featuring excessive impulsivity. However, while prior studies find that mindfulness practice can improve attention, it remains unclear whether it improves other cognitive faculties whose deficiency can contribute to impulsivity. Here, an eight-week mindfulness intervention did not reduce impulsivity on the go/no-go task or Barratt Impulsiveness Scale (BIS-11), nor produce changes in neural correlates of impulsivity (i.e. frontostriatal gray matter, functional connectivity, and dopamine levels) compared to active or wait-list control groups. Separately, long-term meditators (LTMs) did not perform differently than meditation-naïve participants (MNPs) on the go/no-go task. However, LTMs self-reported lower attentional impulsivity, but higher motor and non-planning impulsivity on the BIS-11 than MNPs. LTMs had less striatal gray matter, greater cortico-striatal-thalamic functional connectivity, and lower spontaneous eye-blink rate (a physiological dopamine indicator) than MNPs. LTM total lifetime practice hours (TLPH) did not significantly relate to impulsivity or neurobiological metrics. Findings suggest that neither short- nor long-term mindfulness practice may be effective for redressing impulsive behavior derived from inhibitory motor control or planning capacity deficits in healthy adults. Given the absence of TLPH relationships to impulsivity or neurobiological metrics, differences between LTMs and MNPs may be attributable to pre-existing differences.",2019,"Here, an eight-week mindfulness intervention did not reduce impulsivity on the go/no-go task or Barratt Impulsiveness Scale (BIS-11), nor produce changes in neural correlates of impulsivity (i.e. frontostriatal gray matter, functional connectivity, and dopamine levels) compared to active or wait-list control groups.","['Healthy Adults', 'healthy adults']",['Mindfulness Meditation'],"['attentional impulsivity', 'impulsivity on the go/no-go task or Barratt Impulsiveness Scale (BIS-11), nor produce changes in neural correlates of impulsivity (i.e. frontostriatal gray matter, functional connectivity, and dopamine levels', 'impulsivity or neurobiological metrics', 'LTM total lifetime practice hours (TLPH', 'striatal gray matter, greater cortico-striatal-thalamic functional connectivity, and lower spontaneous eye-blink rate']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}]","[{'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character (finding)'}, {'cui': 'C0222045'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}]",,0.0122635,"Here, an eight-week mindfulness intervention did not reduce impulsivity on the go/no-go task or Barratt Impulsiveness Scale (BIS-11), nor produce changes in neural correlates of impulsivity (i.e. frontostriatal gray matter, functional connectivity, and dopamine levels) compared to active or wait-list control groups.","[{'ForeName': 'Cole', 'Initials': 'C', 'LastName': 'Korponay', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, Wisconsin, 53719, USA.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Dentico', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, Wisconsin, 53719, USA.'}, {'ForeName': 'Tammi R A', 'Initials': 'TRA', 'LastName': 'Kral', 'Affiliation': 'Department of Psychology, University of Wisconsin-Madison, Madison, Wisconsin, 53706, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Ly', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin-Madison, Madison, Wisconsin, 53703, USA.'}, {'ForeName': 'Ayla', 'Initials': 'A', 'LastName': 'Kruis', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin-Madison, Madison, Wisconsin, 53703, USA.'}, {'ForeName': 'Kaley', 'Initials': 'K', 'LastName': 'Davis', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin-Madison, Madison, Wisconsin, 53703, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Goldman', 'Affiliation': 'Center for Healthy Minds, University of Wisconsin-Madison, Madison, Wisconsin, 53703, USA.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Lutz', 'Affiliation': 'Lyon Neuroscience Research Center, Brain Dynamics and Cognition Team, INSERM U1028, CNRS UMR5292, Lyon 1 University, Lyon, France.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Davidson', 'Affiliation': 'Department of Psychiatry, University of Wisconsin-Madison, Madison, Wisconsin, 53719, USA. rjdavids@wisc.edu.'}]",Scientific reports,['10.1038/s41598-019-47662-y']
145,32320144,Weight Change 2 Years After Termination of the Intensive Lifestyle Intervention in the Look AHEAD Study.,"OBJECTIVE


This study evaluated weight changes after cessation of the 10-year intensive lifestyle intervention (ILI) in the Look AHEAD (Action for Health in Diabetes) study. It was hypothesized that ILI participants would be more likely to gain weight during the 2-year observational period following termination of weight-loss-maintenance counseling than would participants in the diabetes support and education (DSE) control group.
METHODS


Look AHEAD was a randomized controlled trial that compared the effects of ILI and DSE on cardiovascular morbidity and mortality in participants with overweight/obesity and type 2 diabetes. Look AHEAD was converted to an observational study in September 2012.
RESULTS


Two years after the end of the intervention (EOI), ILI and DSE participants lost a mean  (SE) of 1.2  (0.2) kg and 1.8  (0.2) kg, respectively (P = 0.003). In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001). Two years after the EOI, ILI participants reported greater use of weight-control behaviors than DSE participants.
CONCLUSIONS


Both groups lost weight during the 2-year follow-up period, but more ILI than DSE participants gained ≥ 2% of EOI weight. Further understanding is needed of factors that affected long-term weight change in both groups.",2020,"In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001).","['participants with overweight/obesity and type 2 diabetes', 'Two years after the end of the intervention (EOI), ILI and DSE participants', 'Weight Change 2 Years']","['ILI and DSE', '10-year intensive lifestyle intervention (ILI', 'Intensive Lifestyle Intervention']","['cardiovascular morbidity and mortality', 'EOI weight', 'gain weight', 'weight-control behaviors']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1321111', 'cui_str': 'Weight control behavior'}]",,0.0402555,"In addition, 31% of ILI and 23.9% of DSE participants gained ≥ 2% (P < 0.001) of EOI weight, whereas 36.3% and 45.9% of the respective groups lost ≥ 2% of EOI weight (P = 0.001).","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Department of Biobehavioral Health Sciences, School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blackburn', 'Affiliation': 'Division of Nutrition, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Bolin', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Clark', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Departments of Preventive Medicine and Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Curtis', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Delahanty', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Gareth R', 'Initials': 'GR', 'LastName': 'Dutton', 'Affiliation': 'Division of Preventive Medicine, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Ewing', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Foreyt', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Gay', 'Affiliation': 'Department of Psychiatry, The Miriam Hospital, Brown Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Gregg', 'Affiliation': 'Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Helen P', 'Initials': 'HP', 'LastName': 'Hazuda', 'Affiliation': 'Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': 'Department of Integrative Physiology and Metabolism, Joslin Diabetes Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Denise K', 'Initials': 'DK', 'LastName': 'Houston', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Jeffery', 'Affiliation': 'Divisions of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'Departments of Preventive Medicine and Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, US Department of Veterans Affairs Puget Sound Health Care System, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kure', 'Affiliation': 'Division of Metabolism, Endocrinology and Nutrition, US Department of Veterans Affairs Puget Sound Health Care System, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Michalski', 'Affiliation': 'Division of General Internal Medicine, Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Montez', 'Affiliation': 'Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Patricio', 'Affiliation': ""Department of Medicine, St. Luke's Roosevelt Hospital Center, Columbia University, New York, New York, USA.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Division of Endocrinology, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': ""Department of Medicine, St. Luke's Roosevelt Hospital Center, Columbia University, New York, New York, USA.""}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Pownall', 'Affiliation': 'Department of Medicine, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Reboussin', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Redmon', 'Affiliation': 'Divisions of Epidemiology and Community Health, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Internal Medicine - Geriatrics, Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Steinburg', 'Affiliation': 'Departments of Preventive Medicine and Psychiatry, The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Walker', 'Affiliation': 'Division of Endocrinology, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Williamson', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Department of Psychiatry, The Miriam Hospital, Brown Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Wyatt', 'Affiliation': 'Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'Division of Digestive Diseases and Nutrition, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22769']
146,31427688,"Effects of remote ischemic conditioning on kidney injury in at-risk patients undergoing elective coronary angiography (PREPARE study): a multicenter, randomized clinical trial.","The ability of remote ischemic preconditioning (RIPC) to prevent contrast-induced nephropathy (CIN) following percutaneous coronary angiography in at-risk patients is controversial. No evidence exists regarding potential RIPC positive effects on renal function and clinical outcomes in the long-term. The PREPARE study was a randomized, prospective, multicenter, and double-blinded trial. A total of 222 patients scheduled for coronary angiography and/or percutaneous transluminal coronary angioplasty with an estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73 m 2 , or eGFR between 40 and 60 mL/min/1.73 m 2  and two further risk factors were allocated to RIPC or control groups. Preventive measures were applied to all patients, including continuous intravenous saline infusion, withdrawal of nephrotoxic drugs, and limited volume of contrast medium. The primary endpoint, namely incidence of CIN, was 3.8% in the control group and 5.1% in the RIPC group (p = 0.74). The secondary endpoints, i.e., changes in serum creatinine and eGFR levels from baseline to 48 hours and from baseline to 12 months following contrast medium exposure, did not differ between both groups. The incidences of all major clinical events at 12 months were similar in both groups. In this population at risk of CIN, preventive strategies were associated with low CIN incidence. RIPC impacted neither the CIN incidence nor both the renal function and clinical outcomes at 1-year follow-up.",2019,The ability of remote ischemic preconditioning (RIPC) to prevent contrast-induced nephropathy (CIN) following percutaneous coronary angiography in at-risk patients is controversial.,"['kidney injury in at-risk patients undergoing elective coronary angiography (PREPARE study', '222 patients scheduled for coronary angiography and/or percutaneous transluminal coronary angioplasty with an estimated glomerular filtration rate (eGFR)\u2009<\u200940\u2009mL/min/1.73\u2009m 2 , or eGFR between 40 and 60\u2009mL/min/1.73\u2009m 2  and two further risk factors']","['remote ischemic preconditioning (RIPC', 'RIPC', 'percutaneous coronary angiography', 'remote ischemic conditioning']","['changes in serum creatinine and eGFR levels', 'namely incidence of CIN', 'incidences of all major clinical events', 'renal function and clinical outcomes']","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C2936173', 'cui_str': 'Percutaneous Transluminal Coronary Angioplasty'}, {'cui': 'C3811844'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",222.0,0.185525,The ability of remote ischemic preconditioning (RIPC) to prevent contrast-induced nephropathy (CIN) following percutaneous coronary angiography in at-risk patients is controversial.,"[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Macia', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Ivanes', 'Affiliation': 'Université de Tours, EA 4245 Transplantation Immunité Inflammation & Loire Valley Cardiovascular Collaboration, CHRU de Tours, Service de Cardiologie, Tours, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Angoulvant', 'Affiliation': 'Université de Tours, EA 4245 Transplantation Immunité Inflammation & Loire Valley Cardiovascular Collaboration, CHRU de Tours, Service de Cardiologie, Tours, France.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Mateus', 'Affiliation': 'Centre hospitalier de Laval, Service de Cardiologie, Laval, France.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Belle', 'Affiliation': ""Centre hospitalier d'Annecy, Service de Cardiologie, Annecy, France.""}, {'ForeName': 'Meyer', 'Initials': 'M', 'LastName': 'Elbaz', 'Affiliation': 'Université Toulouse, CHU Toulouse, Service de Cardiologie, Toulouse, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Morel', 'Affiliation': 'Université de Strasbourg, Service de Cardiologie, Strasbourg, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Furber', 'Affiliation': 'Institut MITOVASC, UMR INSERM U1083 and CNRS 6015, Service de Cardiologie, CHU Angers, Université Angers, Angers, France.'}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Bière', 'Affiliation': 'Institut MITOVASC, UMR INSERM U1083 and CNRS 6015, Service de Cardiologie, CHU Angers, Université Angers, Angers, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Prunier', 'Affiliation': 'Institut MITOVASC, UMR INSERM U1083 and CNRS 6015, Service de Cardiologie, CHU Angers, Université Angers, Angers, France. faprunier@chu-angers.fr.'}]",Scientific reports,['10.1038/s41598-019-47106-7']
147,32268795,Sex Differences in Quality of Life and Clinical Outcomes in Patients With Advanced Heart Failure: Insights From the PAL-HF Trial.,"BACKGROUND


Palliative care improves quality of life in patients with heart failure. Whether men and women with heart failure derive similar benefit from palliative care interventions remains unknown.
METHODS


In a secondary analysis of the PAL-HF trial (Palliative Care in Heart Failure), we analyzed differences in quality of life among men and women with heart failure and assessed for differential effects of the palliative care intervention by sex. Differences in clinical characteristics and quality-of-life metrics were compared between men and women at serial time points. The primary outcome was change in Kansas City Cardiomyopathy Questionnaire score between baseline and 24 weeks.
RESULTS


Among the 71 women and 79 men, there was a significant difference in baseline Kansas City Cardiomyopathy Questionnaire (24.5 versus 36.2, respectively;  P =0.04) but not Functional Assessment of Chronic Illness Therapy-Palliative Care scale (115.7 versus 120.3;  P =0.27) scores. Among those who received the palliative care intervention (33 women and 42 men), women's quality-of-life score remained lower than that of men after enrollment. Treated men's scores were significantly higher than those untreated (6-month Kansas City Cardiomyopathy Questionnaire, 68.0 [interquartile range, 52.6-85.7] versus 41.1[interquartile range, 32.0-78.3];  P =0.047), whereas the difference between treated and untreated women was not significantly different ( P =0.39). Rates of death and rehospitalization, as well as the composite end point, were similar between treated and untreated women and men.
CONCLUSIONS


In the PAL-HF trial, women with heart failure experienced a greater symptom burden and poorer quality of life as compared with men. The change in treated men's Kansas City Cardiomyopathy Questionnaire score between baseline and 24 weeks was significantly higher than those untreated; this trend was not observed in women. Thus, there may be a sex disparity in response to palliative care intervention, suggesting that sex-specific approaches to palliative care may be needed to improve outcomes. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT0158960.",2020,"Rates of death and rehospitalization, as well as the composite end point, were similar between treated and untreated women and men.
","['patients with heart failure', 'Patients With Advanced Heart Failure', '71 women and 79 men', 'men and women with heart failure']",['palliative care intervention'],"['Kansas City Cardiomyopathy Questionnaire score', 'Quality of Life and Clinical Outcomes', 'baseline Kansas City Cardiomyopathy Questionnaire', 'Rates of death and rehospitalization', 'quality of life', 'change in Kansas City Cardiomyopathy Questionnaire score', ""women's quality-of-life score"", 'symptom burden and poorer quality of life', 'Functional Assessment of Chronic Illness Therapy-Palliative Care scale', 'clinical characteristics and quality-of-life metrics']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0699680', 'cui_str': 'Metric'}]",71.0,0.195253,"Rates of death and rehospitalization, as well as the composite end point, were similar between treated and untreated women and men.
","[{'ForeName': 'Lauren K', 'Initials': 'LK', 'LastName': 'Truby', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA (C.O.).'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fiuzat', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Stebbins', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Coles', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Chetan B', 'Initials': 'CB', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Bradi', 'Initials': 'B', 'LastName': 'Granger', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pagidipati', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rymer', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lowenstern', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tulsky', 'Affiliation': ""Division of Palliative Medicine, Department of Medicine, Dana Farber Cancer Institute, Brigham and Women's Hospital, Boston, MA (J.T.).""}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Rogers', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Division of Cardiology, Department of Medicine, Duke University Medical Center, Durham, NC (L.K.T., M.F., A.S., A.C., C.B.P., B.G., N.P., R.A., J.R., A.L., P.S.D., J.G.R., R.J.M.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006134']
148,32162970,Reduction in All-Cause Mortality with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease.,"Rationale:  The IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial demonstrated a significant reduction in all-cause mortality (ACM) risk with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus UMEC/VI in patients with chronic obstructive pulmonary disease (COPD) at risk of future exacerbations. Five hundred seventy-four patients were censored in the original analysis owing to incomplete vital status information. Objectives:  Report ACM and impact of stepping down therapy, following collection of additional vital status data. Methods:  Patients were randomized 2:2:1 to FF/UMEC/VI 100/62.5/25 μg, FF/VI 100/25 μg, or UMEC/VI 62.5/25 μg following a run-in on their COPD therapies. Time to ACM was prespecified. Additional vital status data collection and subsequent analyses were performed  post hoc . Measurements and Main Results:  We report vital status data for 99.6% of the intention-to-treat population ( n  = 10,355), documenting 98 (2.36%) deaths on FF/UMEC/VI, 109 (2.64%) on FF/VI, and 66 (3.19%) on UMEC/VI. For FF/UMEC/VI, the hazard ratio for death was 0.72 (95% confidence interval, 0.53-0.99;  P  = 0.042) versus UMEC/VI and 0.89 (95% confidence interval, 0.67-1.16;  P  = 0.387) versus FF/VI. Independent adjudication confirmed lower rates of cardiovascular and respiratory death and death associated with the patient's COPD. Conclusions:  In this secondary analysis of an efficacy outcome from the IMPACT trial, once-daily single-inhaler FF/UMEC/VI triple therapy reduced the risk of ACM versus UMEC/VI in patients with symptomatic COPD and a history of exacerbations.",2020,"For FF/UMEC/VI, the hazard ratio for death was 0.72","['patients with symptomatic COPD and a history of exacerbations', 'Patients', 'COPD Patients', 'patients with COPD at risk of future exacerbations']","['Fluticasone Furoate/Umeclidinium/Vilanterol', 'FF/UMEC/VI 100/62.5/25', 'fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus UMEC/VI']","['hazard ratio for death', 'rates of cardiovascular and respiratory death, and death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0016884', 'cui_str': 'Future'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3709478', 'cui_str': 'umeclidinium / vilanterol'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.617718,"For FF/UMEC/VI, the hazard ratio for death was 0.72","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'Clinical Sciences.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Crim', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline, Research Triangle Park, North Carolina.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Pulmonary and Critical Care Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Day', 'Affiliation': 'Safety and Medical Governance and.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, United Kingdom.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, Pulmonary and Critical Care, Ann Arbor, Michigan.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'Development, R&D, and.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Section of Epidemiology, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, London, United Kingdom.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lettis', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Manchester', 'Affiliation': 'Global Clinical Science and Delivery, GlaxoSmithKline, Collegeville, Pennsylvania.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'Global Medical Affairs, GlaxoSmithKline, Brentford, Middlesex, United Kingdom.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Midwinter', 'Affiliation': 'Biostatistics, GlaxoSmithKline, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Morris', 'Affiliation': 'Clinical Sciences, GlaxoSmithKline, Research Triangle Park, North Carolina.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Pascoe', 'Affiliation': 'Clinical Sciences.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester Academic Health Science Centre, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland; and.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201911-2207OC']
149,32320171,Effects of alternate nostril breathing exercise on respiratory functions in healthy young adults leading stressful lifestyle.,"Alternate nostril breathing (ANB) is one of the best and easiest breathing exercises (pranayama) of yoga that are good for health and physical fitness. ANB exercise has beneficial and therapeutic effects on respiratory function in both normal as well as diseased humans. This study was conducted with the objective of assessing the physiological effects of short-term ANB exercise on respiratory function in healthy adult individuals leading a stressful life. This prospective interventional study was conducted in the Department of Physiology, Chittagong Medical College (CMC), Chattogram, Bangladesh from July 2017 to June 2018. A total of 100 participants aged 18-20 years, studying in the first year in CMC, were included by using a simple random sampling method. Among them, 50 participants were enrolled in the experimental group. Age- and BMI-matched 50 participants constituted the control group. Height, weight were measured, and BMI was calculated. The participants of the experimental group performed ANB exercise over 4 weeks for 10 min/day. The control participants were neither trained nor allowed to practice nostril breathing during the whole study period. Respiratory parameters like forced vital capacity (FVC), forced expiratory volume in 1st second (FEV 1 ), and peak expiratory flow rate (PEFR) were measured by using a digital spirometer (Chest graph HI-101, Japan). Readings were taken in a healthy upright sitting posture in the control and experimental group initially and after 4 weeks. Student's  t -test was conducted by using SPSS for windows version-23. The mean value of FVC, FEV 1 , PEFR were significantly (P < 0.001) changed after the ANB exercise when compared to the values before breathing exercise. The results of this study suggest that respiratory function is significantly improved after the ANB exercise. Therefore, ANB can be recommended for increasing respiratory efficiency.",2020,"The mean value of FVC, FEV 1 , PEFR were significantly (P < 0.001) changed after the ANB exercise when compared to the values before breathing exercise.","['50 participants were enrolled in the experimental group', 'Department of Physiology, Chittagong Medical College (CMC), Chattogram, Bangladesh from July 2017 to June 2018', '100 participants aged 18-20 years, studying in the first year in CMC, were included by using a simple random sampling method', 'healthy young adults leading stressful lifestyle', 'healthy adult individuals leading a stressful life']","['short-term ANB exercise', 'alternate nostril breathing exercise', 'ANB exercise', 'Alternate nostril breathing (ANB']","['respiratory functions', 'respiratory function', 'mean value of FVC, FEV 1 , PEFR', 'Respiratory parameters like forced vital capacity (FVC), forced expiratory volume in 1st second (FEV 1 ), and peak expiratory flow rate (PEFR', 'Height, weight']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0449370', 'cui_str': 'Method of sampling'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0030735', 'cui_str': 'Peak expiratory flow rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",100.0,0.0220407,"The mean value of FVC, FEV 1 , PEFR were significantly (P < 0.001) changed after the ANB exercise when compared to the values before breathing exercise.","[{'ForeName': 'Iffat', 'Initials': 'I', 'LastName': 'Jahan', 'Affiliation': 'Department of Physiology, Southern Medical College, Chattogram, Bangladesh. runurono@gmail.com.'}, {'ForeName': 'Momtaz', 'Initials': 'M', 'LastName': 'Begum', 'Affiliation': 'Department of Physiology, Chittagong Medical College, Chattogram, Bangladesh.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhter', 'Affiliation': 'Department of Physiology, Chittagong Medical College, Chattogram, Bangladesh.'}, {'ForeName': 'Md Zakirul', 'Initials': 'MZ', 'LastName': 'Islam', 'Affiliation': 'Department of Pharmacology, Eastern Medical College, Cumilla, Bangladesh.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Jahan', 'Affiliation': 'Department of Internal Medicine, United Hospital, Dhaka, Bangladesh.'}, {'ForeName': 'Mainul', 'Initials': 'M', 'LastName': 'Haque', 'Affiliation': 'Unit of Pharmacology, Faculty of Medicine and Defence Health, Universiti Pertahanan Nasional Malaysia (National Defence University of Malaysia), Kuala Lumpur, Malaysia.'}]",Journal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique,['10.15586/jptcp.v27i1.668']
150,32320465,Phase 1 Safety and Immunogenicity Study of a Respiratory Syncytial Virus Vaccine With an Adenovirus 26 Vector Encoding Prefusion F (Ad26.RSV.preF) in Adults Aged ≥60 Years.,"BACKGROUND


Despite the high disease burden of respiratory syncytial virus (RSV) in older adults, there is no approved vaccine. We evaluated the experimental RSV vaccine, Ad26.RSV.preF, a replication-incompetent adenovirus 26 vector encoding the F protein stabilized in prefusion conformation.
METHODS


This phase 1 clinical trial was performed in healthy adults aged ≥60 years. Seventy-two participants received 1 or 2 intramuscular injections of low-dose (LD; 5 × 1010 vector particles) or high-dose (HD; 1 × 1011 vector particles) Ad26.RSV.preF vaccine or placebo, with approximately 12 months between doses and 2-year follow-up for safety and immunogenicity outcomes.
RESULTS


Solicited adverse events were reported by 44% of vaccine recipients and were transient and mild or moderate in intensity. No serious adverse events were related to vaccination. After the first vaccination, geometric mean titers for RSV-A2 neutralization increased from baseline (432 for LD and 512 for HD vaccine) to day 29 (1031 for LD and 1617 for HD). Pre-F-specific antibody geometric mean titers and median frequencies of F-specific interferon γ-secreting T cells also increased substantially from baseline. These immune responses were still maintained above baseline levels 2 years after immunization and could be boosted with a second immunization at 1 year.
CONCLUSIONS


Ad26.RSV.preF (LD and HD) had an acceptable safety profile and elicited sustained humoral and cellular immune responses after a single immunization in older adults.",2020,"These immune responses were still maintained above baseline levels 2 years post-immunization and could be boosted with a second immunization at 1 year.
","['healthy adults aged ≥60 years', 'older adults', 'adults 60 years and older']","['Ad26.RSV.preF (LD and HD', 'Ad26.RSV.preF 5x1010 vp (LD) or 1x1011 vp (HD) or placebo', 'Respiratory Syncytial Virus Vaccine with an Adenovirus 26 Vector Encoding Pre-Fusion F (Ad26.RSV.preF']",['geometric mean titers (GMTs) for RSV-A2 neutralization'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0887894', 'cui_str': 'RSV Vaccines'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}]",,0.259988,"These immune responses were still maintained above baseline levels 2 years post-immunization and could be boosted with a second immunization at 1 year.
","[{'ForeName': 'Kristi', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Arangassery Rosemary', 'Initials': 'AR', 'LastName': 'Bastian', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Robert Allen', 'Initials': 'RA', 'LastName': 'Feldman', 'Affiliation': 'QPS Miami Research Associates, Miami, Florida, USA.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Omoruyi', 'Affiliation': 'Janssen Infectious Diseases, Beerse, Belgium.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'de Paepe', 'Affiliation': 'Janssen Infectious Diseases, Beerse, Belgium.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hendriks', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Hester', 'Initials': 'H', 'LastName': 'van Zeeburg', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Godeaux', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Johannes P M', 'Initials': 'JPM', 'LastName': 'Langedijk', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Sadoff', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Callendret', 'Affiliation': 'Janssen Vaccines & Prevention, Leiden, the Netherlands.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa193']
151,32322880,Neural correlates of cognitive bias modification for interpretation.,"The effectiveness of cognitive bias modification for interpretation (CBM-I), a treatment method employed to reduce social anxiety (SA), has been examined. However, the neural correlates of CBM-I remain unclear, and we aimed to elucidate brain activities during intervention and activity changes associated with CBM-I effectiveness in a pre-post intervention comparison. Healthy participants divided into two groups (CBM, control) were scanned before, during and after intervention using functional magnetic resonance imaging. Ambiguous social situations followed by positive outcomes were repeatedly imagined by the CBM group during intervention, while half of the outcomes in the control group were negative. Whole-brain analysis revealed that activation of the somatomotor and somatosensory areas, occipital lobe, fusiform gyrus and thalamus during intervention was significantly greater in the CBM than in the control group. Furthermore, altered activities in the somatomotor and somatosensory areas, occipital lobe and posterior cingulate gyrus during interpreting ambiguous social situations showed a significant group × change in SA interaction. Our result suggests that when facing ambiguous social situations, positive imagery instilled by CBM-I is recalled, and interpretations are modified to contain social reward. These findings may help to suggest an alternative manner of enhancing CBM-I effectiveness from a cognitive-neuroscience perspective.",2020,"Whole-brain analysis revealed that activation of the somatomotor and somatosensory areas, occipital lobe, fusiform gyrus and thalamus during intervention was significantly greater in the CBM than in the control group.",['Healthy participants'],[],"['social anxiety (SA', 'activation of the somatomotor and somatosensory areas, occipital lobe, fusiform gyrus and thalamus during intervention']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0458361', 'cui_str': 'Somesthetic area'}, {'cui': 'C0028785', 'cui_str': 'Occipital lobe structure'}, {'cui': 'C0228243', 'cui_str': 'Structure of lateral occipitotemporal gyrus'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0220369,"Whole-brain analysis revealed that activation of the somatomotor and somatosensory areas, occipital lobe, fusiform gyrus and thalamus during intervention was significantly greater in the CBM than in the control group.","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Sakaki', 'Affiliation': 'Department of Functional Brain Imaging, Graduate School of Medicine, Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Nozawa', 'Affiliation': 'Research Institute for the Earth Inclusive Sensing Empathizing with Silent Voices, Tokyo Institute of Technology, Tokyo 152-8550, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Ikeda', 'Affiliation': 'Department of Ubiquitous Sensing, Institute of Development, Aging and Cancer, Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Kawashima', 'Affiliation': 'Department of Ubiquitous Sensing, Institute of Development, Aging and Cancer, Tohoku University, Sendai 980-8575, Japan.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsaa026']
152,30587335,Measuring recovery in health-related quality of life during and after pulmonary exacerbations in patients with cystic fibrosis.,"BACKGROUND


We explored the time-dependent impact of pulmonary exacerbations (PEx) on health-related quality of life (HRQoL) using Cystic Fibrosis Questionnaire-Revised (CFQ-R) data from 2 large cystic fibrosis (CF) trials.
METHODS


This exploratory post-hoc analysis evaluated the impact of PEx on CFQ-R domains of functioning in 80 patients with CF (homozygous for F508del-CFTR), aged ≥14 years randomized to placebo in the TRAFFIC and TRANSPORT trials who experienced 1 PEx.
RESULTS


Scores on the CFQ-R were significantly lower within 1 week of PEx start in 8 out of 12 domains (Respiratory Symptoms, Physical Functioning, Emotional Functioning, Health Perceptions, Role Functioning, Social Functioning, Eating, and Vitality). Patients whose PEx was treated with hospitalization or intravenous antibiotics had greater reductions in some domains of HRQoL compared with those treated with oral antibiotics. In the immediate weeks post-PEx, improvement was seen on Emotional Functioning, Respiratory Symptoms, and Health Perceptions, while further decline was seen for Eating, Physical Functioning, Role Functioning, Vitality, and Weight. For some measures (Physical Functioning, Vitality), full recovery to pre-PEx levels took several weeks.
CONCLUSIONS


Pulmonary exacerbations have significant effects on multiple domains of HRQoL, and recovery across multiple domains post-PEx can take several weeks. These findings provide insight into the impact of PEx on patient HRQoL and recovery post-PEx.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov identifiers, NCT01807923 and NCT01807949.",2019,"In the immediate weeks post-PEx, improvement was seen on Emotional Functioning, Respiratory Symptoms, and Health Perceptions, while further decline was seen for Eating, Physical Functioning, Role Functioning, Vitality, and Weight.","['80 patients with CF (homozygous for F508del-CFTR), aged ≥14\u202fyears randomized to', 'patients with cystic fibrosis', '2 large cystic fibrosis (CF) trials']",['placebo'],"['Physical Functioning, Emotional Functioning, Health Perceptions, Role Functioning, Social Functioning, Eating, and Vitality', 'Eating, Physical Functioning, Role Functioning, Vitality, and Weight', 'health-related quality of life (HRQoL) using Cystic Fibrosis Questionnaire-Revised (CFQ-R) data', 'measures (Physical Functioning, Vitality), full recovery to pre-PEx levels took several weeks', 'CFQ-R', 'Emotional Functioning, Respiratory Symptoms, and Health Perceptions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}]",80.0,0.111542,"In the immediate weeks post-PEx, improvement was seen on Emotional Functioning, Respiratory Symptoms, and Health Perceptions, while further decline was seen for Eating, Physical Functioning, Role Functioning, Vitality, and Weight.","[{'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Flume', 'Affiliation': 'Medical University of South Carolina, 96 Jonathan Lucas Street, 812-CSB, Charleston, SC 29425, USA. Electronic address: flumepa@musc.edu.'}, {'ForeName': 'Ellison D', 'Initials': 'ED', 'LastName': 'Suthoff', 'Affiliation': 'Formerly of Vertex Pharmaceuticals Incorporated, 50 Northern Avenue, Boston, MA 02210, USA. Electronic address: Ellison@suthoff.com.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kosinski', 'Affiliation': 'Quality Metric Incorporated, Now Part of Optum Insight, 1301 Atwood Avenue, Johnston, RI 02919, USA. Electronic address: mkosinski@qualitymetric.com.'}, {'ForeName': 'Gautham', 'Initials': 'G', 'LastName': 'Marigowda', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, 50 Northern Avenue, Boston, MA 02210, USA. Electronic address: Gautham_Marigowda@vrtx.com.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Quittner', 'Affiliation': ""Nicklaus Children's Research Institute, 3100 SW 62nd Avenue, Miami, FL 33155, USA. Electronic address: Alexandra.Quittner@mch.com.""}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2018.12.004']
153,32297442,Acupuncture for Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer Survivors: A Randomized Controlled Pilot Trial.,"BACKGROUND


Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most debilitating long-term side effects in breast cancer survivors. We conducted a randomized controlled pilot trial to assess the feasibility, safety, and effects of an acupuncture intervention on CIPN in this population.
PATIENTS AND METHODS


Women with stage I-III breast cancer with grade 1 or higher CIPN after taxane-containing adjuvant chemotherapy were randomized 1:1 to an immediate acupuncture (IA) arm or to a waitlist control group (CG). Participants in the IA arm received 18 sessions of acupuncture over 8 weeks, then received no additional acupuncture. Patients in the CG arm received usual care over 8 weeks, followed by nine sessions of acupuncture over 8 weeks. Measures including Patient Neurotoxicity Questionnaire (PNQ), Functional Assessment of Cancer Therapy-Neurotoxicity subscale (FACT-NTX), and Brief Pain Inventory-short form (BPI-SF) were collected at baseline and at 4, 8, and 16 weeks after enrollment.
RESULTS


Forty women (median age, 54) were enrolled (20 to IA and 20 to CG), with median time between completion of chemotherapy and enrollment of 14 months (range 1-92). At 8 weeks, participants in the IA arm experienced significant improvements in PNQ sensory score (-1.0 ± 0.9 vs. -0.3 ± 0.6; p = .01), FACT-NTX summary score (8.7 ± 8.9 vs. 1.2 ± 5.4; p = .002), and BPI-SF pain severity score (-1.1 ± 1.7 vs. 0.3 ± 1.5; p = .03), compared with those in the CG arm. No serious side effects were observed.
CONCLUSION


Women with CIPN after adjuvant taxane therapy for breast cancer experienced significant improvements in neuropathic symptoms from an 8-week acupuncture treatment regimen. Additional larger studies are needed to confirm these findings.
IMPLICATIONS FOR PRACTICE


Chemotherapy-induced peripheral neuropathy (CIPN) is a toxicity that often persists for months to years after the completion of adjuvant chemotherapy for early breast cancer. In a randomized pilot trial of 40 breast cancer survivors with CIPN, an 8-week acupuncture intervention (vs. usual care) led to a statistically and clinically significant improvement in subjective sensory symptoms including neuropathic pain and paresthesia. Given the lack of effective therapies and established safety profile of acupuncture, clinicians may consider acupuncture as a treatment option for mild to moderate CIPN in practice.",2020,"No serious side effects were observed.
","['Women with stage I-III breast cancer with grade 1 or higher CIPN after', 'breast cancer survivors', '40 breast cancer survivors with CIPN, an 8-week', 'Forty women (median age, 54) were enrolled (20 to IA and 20 to CG), with median time between completion of chemotherapy and enrollment of 14 months (range 1-92', 'Breast Cancer Survivors']","['Acupuncture', 'taxane-containing adjuvant chemotherapy', 'acupuncture', 'taxane therapy', 'immediate acupuncture (IA) arm or to a waitlist control group (CG', 'acupuncture intervention']","['neuropathic symptoms', 'serious side effects', 'FACT-NTX summary score', 'BPI-SF pain severity score', 'PNQ sensory score', 'subjective sensory symptoms including neuropathic pain and paresthesia', 'Patient Neurotoxicity Questionnaire (PNQ), Functional Assessment of Cancer Therapy-Neurotoxicity subscale (FACT-NTX), and Brief Pain Inventory-short form (BPI-SF']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3873567', 'cui_str': 'Peripheral neuropathy due to and following chemotherapy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0423551', 'cui_str': 'Sensory symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}]",40.0,0.156072,"No serious side effects were observed.
","[{'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Giobbie-Hurder', 'Affiliation': 'Division of Biostatistics, Department of Data Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Freedman', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Im Hee', 'Initials': 'IH', 'LastName': 'Shin', 'Affiliation': 'Department of Medical Statistics and Informatics, School of Medicine at the Catholic University of Daegu, Daegu, Republic of Korea.'}, {'ForeName': 'Nancy U', 'Initials': 'NU', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Rosenthal', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Ligibel', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0489']
154,30395790,The Effect of Added Peanut Butter on the Glycemic Response to a High-Glycemic Index Meal: A Pilot Study.,"OBJECTIVE


The purpose of this pilot study was to determine whether supplementation of a high-glycemic index breakfast meal with peanut butter attenuates the glycemic response.
METHODS


Sixteen healthy adults, aged 24.1 ± 3.5 years, reported in the morning to a nutrition assessment laboratory for two days of data collection, having fasted 8 to 12 hours. On day 1 (control), fasting blood glucose (BG) was measured using glucometers, then participants consumed two slices of white bread and 250 mL apple juice (60 g carbohydrate) within 15 minutes. BG was measured again at 15, 30, 60, 90, and 120 minutes after the first bite of the meal. On day 2, the protocol was repeated, except 32 g (2 tbsp) of peanut butter was added to the meal (treatment).
RESULTS


The spike in BG was significantly lower on the treatment versus control day (35.8 ± 16.4 vs. 51.0 ± 20.8 mg/dL, respectively; p < 0.01), and BG was significantly lower on the treatment day at 15, 30, and 60 minutes post-meal consumption (p < 0.05).
CONCLUSIONS


This study indicates that supplementation with 32 g (2 tbsp) peanut butter attenuates the magnitude of BG spike and overall glycemic response to high-glycemic index meal and may be a practical, beneficial strategy to prevent undesirable elevations in BG.",2019,"BG was measured again at 15, 30, 60, 90, and 120 minutes after the first bite of the meal.","['Sixteen healthy adults, aged 24.1\u2009±\u20093.5 years, reported in the morning to a nutrition assessment laboratory for two days of data collection, having fasted 8 to 12\u2009hours']","['high-glycemic index breakfast meal with peanut butter', 'peanut butter', 'peanut butter was added to the meal (treatment', 'Added Peanut Butter']","['fasting blood glucose (BG', 'BG', 'BG spike and overall glycemic response', 'spike in BG']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0028708', 'cui_str': 'Nutritional Assessment'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1292430', 'cui_str': '12 hours'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0453349', 'cui_str': 'Peanut butter (substance)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",16.0,0.0295888,"BG was measured again at 15, 30, 60, 90, and 120 minutes after the first bite of the meal.","[{'ForeName': 'Lesley N', 'Initials': 'LN', 'LastName': 'Lilly', 'Affiliation': 'a Department of Nutrition, School of Mathematics Science and Engineering , University of the Incarnate Word , San Antonio , Texas , USA ;'}, {'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Heiss', 'Affiliation': 'a Department of Nutrition, School of Mathematics Science and Engineering , University of the Incarnate Word , San Antonio , Texas , USA ;'}, {'ForeName': 'Sofia F', 'Initials': 'SF', 'LastName': 'Maragoudakis', 'Affiliation': 'a Department of Nutrition, School of Mathematics Science and Engineering , University of the Incarnate Word , San Antonio , Texas , USA ;'}, {'ForeName': 'Kelli L', 'Initials': 'KL', 'LastName': 'Braden', 'Affiliation': 'a Department of Nutrition, School of Mathematics Science and Engineering , University of the Incarnate Word , San Antonio , Texas , USA ;'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Smith', 'Affiliation': 'b Department of Mathematics and Statistics, School of Mathematics, Science, and Engineering , University of the Incarnate Word , San Antonio , Texas , USA.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2018.1519404']
155,31911146,Immunogenicity and safety of different dosing schedules of trivalent inactivated influenza vaccine in pregnant women with HIV: a randomised controlled trial.,"BACKGROUND


Standard-dose, seasonal, trivalent, inactivated influenza vaccine induces moderate-to-low haemagglutination-inhibition antibody responses in people living with HIV. This study assessed the immunogenicity and safety of different dosing schedules of inactivated influenza vaccine in pregnant women living with HIV in South Africa.
METHODS


In this double-blind, randomised, controlled trial, we recruited pregnant women with HIV from seven antenatal clinics in Soweto, South Africa. Pregnant women were eligible if they were aged 18-38 years, infected with HIV, and had an estimated gestational age of 12-36 weeks. Women were randomly assigned (1:1:1), using a computer-generated randomisation list, to receive inactivated influenza vaccine containing 15 μg of each of the three seasonal influenza strains for that year, as a single dose, a double dose, or two single doses 1 month apart. Participants and study personnel were masked to group allocation. Haemagglutination-inhibition antibody responses were measured for all groups in the mothers at enrolment and at 1 month after each vaccine dose, and in the single-dose and double-dose groups within 7 days of birth in the neonates. Immunogenicity analyses only included women with visits 28-35 days apart and infants who were born at least 28 days after maternal immunisation. The primary was seroconversion rate to each of the vaccine strains in the mothers 1 month after completion of the dosing schedule, and the primary safety outcomes were frequency of local and systemic reactions. Safety was assessed in mothers and infants until 24 weeks post partum and analysed in all participants who received at least one dose of vaccine. This study is registered with ClinicalTrials.gov, NCT01527825, and is closed to accrual.
FINDINGS


Between Feb 11, and June 6, 2013, 800 pregnant women living with HIV were enrolled and randomly assigned to the single-dose (n=266), double-dose (n=265), or two-single-doses (n=269) group. In the analysable population, seroconversion rates in mothers 1 month after the final vaccine dose were significantly higher in the double-dose group (n=230; ranging from 29% to 65% for the three vaccine strains) than in the single-dose group (n=230; ranging from 18% to 49%; p≤0·019 for the three vaccine strains), but were similar between the two-single-doses group (n=220; ranging from 23% to 52%) and the single-dose group (p≥0·20 for the three vaccine strains). Safety outcomes were similar in the three groups, except for more injection-site reactions in recipients in the double-dose group.
INTERPRETATION


A regimen of double-dose inactivated influenza vaccine gave slightly greater immunogenicity than did a single-dose regimen in pregnant women living with HIV. However, immunogenicity in the double-dose group was still lower than historical data from the same setting in pregnant women without HIV. More immunogenic vaccines are needed for pregnant women living with HIV to enhance transplacental transfer of vaccine-induced protective antibodies to their newborn infants.
FUNDING


Bill & Melinda Gates Foundation.",2020,"Safety outcomes were similar in the three groups, except for more injection-site reactions in recipients in the double-dose group.
","['pregnant women living with HIV in South Africa', 'included women with visits 28-35 days apart and infants who were born at least 28 days after maternal immunisation', 'pregnant women living with HIV', 'Pregnant women were eligible if they were aged 18-38 years, infected with HIV, and had an estimated gestational age of 12-36 weeks', 'pregnant women with HIV', 'pregnant women without HIV', 'Between Feb 11, and June 6, 2013, 800 pregnant women living with HIV', 'pregnant women with HIV from seven antenatal clinics in Soweto, South Africa', 'people living with HIV']","['vaccine', 'computer-generated randomisation list, to receive inactivated influenza vaccine', 'trivalent inactivated influenza vaccine', 'double-dose inactivated influenza vaccine', 'inactivated influenza vaccine']","['seroconversion rates', 'frequency of local and systemic reactions', 'injection-site reactions', 'seroconversion rate', 'immunogenicity and safety', 'Safety', 'immunogenicity', 'Safety outcomes', 'Immunogenicity and safety', 'Haemagglutination-inhibition antibody responses']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}]",800.0,0.620166,"Safety outcomes were similar in the three groups, except for more injection-site reactions in recipients in the double-dose group.
","[{'ForeName': 'Marta C', 'Initials': 'MC', 'LastName': 'Nunes', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, School of Pathology, Faculty of Health Sciences, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation, SARCHI: Vaccine Preventable Diseases, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: nunesm@rmpru.co.za.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, School of Pathology, Faculty of Health Sciences, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation, SARCHI: Vaccine Preventable Diseases, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Moultrie', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, School of Pathology, Faculty of Health Sciences, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation, SARCHI: Vaccine Preventable Diseases, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, School of Pathology, Faculty of Health Sciences, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation, SARCHI: Vaccine Preventable Diseases, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Ortiz', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Keith P', 'Initials': 'KP', 'LastName': 'Klugman', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, School of Pathology, Faculty of Health Sciences, Johannesburg, South Africa.'}, {'ForeName': 'Eric A F', 'Initials': 'EAF', 'LastName': 'Simões', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, School of Pathology, Faculty of Health Sciences, Johannesburg, South Africa; School of Public Health, Center for Global Health, University of Colorado, Aurora, CO, USA; Department of Pediatric Infectious Diseases, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Weinberg', 'Affiliation': 'Department of Pediatrics, Medicine and Pathology, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, School of Pathology, Faculty of Health Sciences, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation, SARCHI: Vaccine Preventable Diseases, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(19)30322-4']
156,30589391,Two and Four Weeks of β-Hydroxy-β-Methylbutyrate (HMB) Supplementations Reduce Muscle Damage Following Eccentric Contractions.,"OBJECTIVE


This study investigated the effect of β-hydroxy-β-methylbutyrate (HMB) supplementation for either 2 or 4 weeks on the muscle damage after elbow flexors after eccentric contractions (ECCs).
METHODS


Twenty-eight untrained men were completed the double-blind, placebo-controlled, parallel design study. The subjects were randomly assigned to the ingestion of HMB supplement for 2 weeks (HMB 2-week, n = 10), for 4 weeks (HMB 4-week, n = 10), or a placebo group (PL, n = 8). Subjects of HMB 2-week and HMB 4-week consumed 3 g HMB per day, and they performed 6 sets of 10 ECCs at 100% maximal voluntary contraction (MVC) using a dumbbell. Changes in MVC torque, range of motion (ROM), upper arm circumference, muscle soreness, and muscle stiffness were assessed before, immediately after, and 1, 2, and 5 days after exercise.
RESULTS


MVC torque and ROM were significantly higher in the HMB 2-week and HMB 4-week groups than in the PL group after ECCs (p < 0.05). The upper arm circumference was significantly smaller in the HMB 2- and 4-week groups than in the PL group after ECCs (p < 0.05). In addition, muscle stiffness at 150° was significantly lower in the HMB 2- and 4-week groups than in the PL group at immediately after ECCs (p < 0.05). However, there was no difference in all outcomes between HMB 2-week and HMB 4-week.
CONCLUSION


We concluded that more than 2 weeks of HMB supplementation has a positive role for untrained subjects to prevent the muscle damage after ECCs.",2019,The upper arm circumference was significantly smaller in the HMB 2- and 4-week groups than in the PL group after ECCs (p < 0.05).,"['Twenty-eight untrained men', 'untrained subjects']","['β-Hydroxy-β-Methylbutyrate (HMB', 'placebo', 'ingestion of HMB supplement', 'HMB supplementation', 'β-hydroxy-β-methylbutyrate (HMB) supplementation']","['upper arm circumference', 'muscle stiffness', 'MVC torque, range of motion (ROM), upper arm circumference, muscle soreness, and muscle stiffness', 'MVC torque and ROM']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0446516', 'cui_str': 'Brachiums'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0221170', 'cui_str': 'Muscular stiffness'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}]",28.0,0.0371189,The upper arm circumference was significantly smaller in the HMB 2- and 4-week groups than in the PL group after ECCs (p < 0.05).,"[{'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Tsuchiya', 'Affiliation': 'a Faculty of Modern Life , Teikyo Heisei University , Tokyo , Japan.'}, {'ForeName': 'Kinjiro', 'Initials': 'K', 'LastName': 'Hirayama', 'Affiliation': 'a Faculty of Modern Life , Teikyo Heisei University , Tokyo , Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Ueda', 'Affiliation': 'b Faculty of Health and Medical Science , Teikyo Heisei University , Chiba , Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Ochi', 'Affiliation': 'c Faculty of Bioscience and Applied Chemistry , Hosei University , Tokyo , Japan.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2018.1528905']
157,31920733,A Proof-of-Mechanism Study to Test Effects of the NMDA Receptor Antagonist Lanicemine on Behavioral Sensitization in Individuals With Symptoms of PTSD.,"Background:  Individuals with post-traumatic stress disorder (PTSD) have a heightened sensitivity to subsequent stressors, addictive drugs, and symptom recurrence, a form of behavioral sensitization. N-methyl-D-aspartate receptors (NMDARs) are involved in the establishment and activation of sensitized behavior.  Objective:  We describe a protocol of a randomized placebo-controlled Phase 1b proof-of-mechanism trial to examine target engagement, safety, tolerability, and possible efficacy of the NMDAR antagonist lanicemine in individuals with symptoms of PTSD (Clinician Administered PTSD Scale [CAPS-5] score ≥ 25) and evidence of behavioral sensitization measured as enhanced anxiety-potentiated startle (APS; T-score ≥ 2.8).  Methods:  Subjects (n = 24; age range 21-65) receive three 60-min intravenous infusions of placebo or 100 mg lanicemine over 5 non-consecutive days. Primary endpoint is change in APS from pre-treatment baseline to after the third infusion. NMDAR engagement is probed with resting state EEG gamma band power, 40 Hz auditory steady state response, the mismatch negativity amplitude, and P50 sensory gating. Change in CAPS-5 scores is an exploratory clinical endpoint. Bayesian statistical methods will evaluate endpoints to determine suitability of this agent for further study.  Conclusion:  In contrast to traditional early-phase trials that use symptom severity to track treatment efficacy, this study tracks engagement of the study drug on expression of behavioral sensitization, a functional mechanism likely to cut across disorders. This experimental therapeutics design is consistent with recent NIMH-industry collaborative studies, and could serve as a template for testing novel pharmacological agents in psychiatry.  Clinical Trial Registration:  www.ClinicalTrials.gov, identifier NCT03166501.",2019,"NMDAR engagement is probed with resting state EEG gamma band power, 40 Hz auditory steady state response, the mismatch negativity amplitude, and P50 sensory gating.","['Individuals with post-traumatic stress disorder (PTSD', 'individuals with symptoms of PTSD (Clinician Administered PTSD Scale [CAPS-5] score ≥ 25', 'Methods:  Subjects (n = 24; age range 21-65', 'Individuals With Symptoms of PTSD']","['placebo or 100 mg lanicemine', 'N-methyl-D-aspartate receptors (NMDARs', 'NMDA Receptor Antagonist Lanicemine', 'placebo', 'NMDAR antagonist lanicemine']","['resting state EEG gamma band power, 40 Hz auditory steady state response, the mismatch negativity amplitude, and P50 sensory gating', 'change in APS', 'CAPS-5 scores']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0222045'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2697880'}, {'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}, {'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0219874', 'cui_str': 'tyrosine protein kinase p50csk'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.147479,"NMDAR engagement is probed with resting state EEG gamma band power, 40 Hz auditory steady state response, the mismatch negativity amplitude, and P50 sensory gating.","[{'ForeName': 'Marijn', 'Initials': 'M', 'LastName': 'Lijffijt', 'Affiliation': 'Research Service Line, Michael E. DeBakey VA Medical Center, Houston, TX, United States.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Green', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, UTHealth McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, United States.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Balderston', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, United States.'}, {'ForeName': 'Tabish', 'Initials': 'T', 'LastName': 'Iqbal', 'Affiliation': 'Research Service Line, Michael E. DeBakey VA Medical Center, Houston, TX, United States.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Atkinson', 'Affiliation': 'Department of Anesthesiology, Michael E. DeBakey VA Medical Center, Houston, TX, United States.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Vo-Le', 'Affiliation': 'Research Service Line, Michael E. DeBakey VA Medical Center, Houston, TX, United States.'}, {'ForeName': 'Bylinda', 'Initials': 'B', 'LastName': 'Vo-Le', 'Affiliation': 'Research Service Line, Michael E. DeBakey VA Medical Center, Houston, TX, United States.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': ""O'Brien"", 'Affiliation': 'Research Service Line, Michael E. DeBakey VA Medical Center, Houston, TX, United States.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grillon', 'Affiliation': 'Department of Pediatrics - Center for Evidence Based Medicine, UTHealth McGovern Medical School, University of Texas Health Science Center at Houston, Houston, TX, United States.'}, {'ForeName': 'Alan C', 'Initials': 'AC', 'LastName': 'Swann', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, United States.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2019.00846']
158,30503589,The Effects of Exercise on Falls in Older People With Dementia Living in Nursing Homes: A Randomized Controlled Trial.,"OBJECTIVES


To investigate exercise effects on falls in people with dementia living in nursing homes, and whether effects were dependent on sex, dementia type, or improvement in balance. A further aim was to describe the occurrence of fall-related injuries.
DESIGN


A cluster-randomized controlled trial.
SETTING AND PARTICIPANTS


The Umeå Dementia and Exercise study was set in 16 nursing homes in Umeå, Sweden and included 141 women and 45 men, a mean age of 85 years, and with a mean Mini-Mental State Examination score of 15.
INTERVENTION


Participants were randomized to the high-intensity functional exercise program or a seated attention control activity; each conducted 2-3 times per week for 4 months.
MEASURES


Falls and fall-related injuries were followed for 12 months (after intervention completion) by blinded review of medical records. Injuries were classified according to severity.
RESULTS


During follow-up, 118 (67%) of the participants fell 473 times in total. At the interim 6-month follow-up, the incidence rate was 2.7 and 2.8 falls per person-year in exercise and control group, respectively, and at 12-month follow-up 3.0 and 3.2 falls per person-year, respectively. Negative binomial regression analyses indicated no difference in fall rate between groups at 6 or 12 months (incidence rate ratio 0.9, 95% confidence interval (CI) 0.5-1.7, P = .838 and incidence rate ratio 0.9, 95% CI 0.5-1.6, P = .782, respectively). No differences in exercise effects were found according to sex, dementia type, or improvement in balance. Participants in the exercise group were less likely to sustain moderate/serious fall-related injuries at 12-month follow-up (odds ratio 0.31, 95% CI 0.10-0.94, P = .039).
CONCLUSIONS/IMPLICATIONS


In older people with dementia living in nursing homes, a high-intensity functional exercise program alone did not prevent falls when compared with an attention control group. In high-risk populations, in which multimorbidity and polypharmacy are common, a multifactorial fall-prevention approach may be required. Encouraging effects on fall-related injuries were observed, which merits future investigations.",2019,"In older people with dementia living in nursing homes, a high-intensity functional exercise program alone did not prevent falls when compared with an attention control group.","['older people with dementia living in nursing homes', 'Older People With Dementia Living in Nursing Homes', 'people with dementia living in nursing homes', '16 nursing homes in Umeå, Sweden and included 141 women and 45 men, a mean age of 85\xa0years, and with a mean Mini-Mental State Examination score of\xa015']","['Exercise', 'high-intensity functional exercise program or a seated attention control activity']","['sustain moderate/serious fall-related injuries', 'exercise effects', 'incidence rate', 'Falls and fall-related injuries', 'fall rate']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home (finding)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",141.0,0.110291,"In older people with dementia living in nursing homes, a high-intensity functional exercise program alone did not prevent falls when compared with an attention control group.","[{'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Toots', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden; Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden. Electronic address: annika.toots@umu.se.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wiklund', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden; Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Littbrand', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden; Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Ellinor', 'Initials': 'E', 'LastName': 'Nordin', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordström', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Lillemor', 'Initials': 'L', 'LastName': 'Lundin-Olsson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Yngve', 'Initials': 'Y', 'LastName': 'Gustafson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Rosendahl', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden; Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2018.10.009']
159,32320729,Randomized in situ trial on the efficacy of Carbopol in enhancing fluoride / stannous anti-erosive properties.,"OBJECTIVE


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


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


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


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


Under highly erosive and abrasive conditions, rinsing with solutions containing sodium fluoride plus stannous chloride, associated or not with the Carbopol polymer, is an effective approach to control enamel erosive wear.",2020,Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05).,"['Cylindrical bovine enamel specimens', 'enamel erosive wear']","['sodium fluoride plus stannous chloride', 'FS (500\u2009ppm F- +800\u2009ppm', 'sodium fluoride with stannous chloride (FS) solution', 'Carbopol', 'bioadhesive polymer (Carbopol 980', 'palatal appliance containing 4 specimens: two were submitted to an erosion model (2\u2009h of pellicle formation; immersion in 1% citric acid, pH 2.3, for 5\u2009min, 4x/day; 1\u2009h intervals of saliva exposure']",['enamel loss'],"[{'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439679', 'cui_str': 'Erosive'}]","[{'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0075160', 'cui_str': 'stannous chloride'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0108434', 'cui_str': 'Carbopol'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C1542809', 'cui_str': 'Carbopol 980'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C1257926', 'cui_str': 'Salivary Acquired Pellicle'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}]",,0.0322465,Erosion/abrasion challenge resulted in significantly higher enamel loss than erosion only (p < 0.05).,"[{'ForeName': 'Daniele Mara da Silva', 'Initials': 'DMDS', 'LastName': 'Ávila', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: daniele-mara@uol.com.br.'}, {'ForeName': 'Rayssa Ferreira', 'Initials': 'RF', 'LastName': 'Zanatta', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil; Department of Restorative Dentistry, Dental School, University of Taubaté, Taubaté, Brazil. Electronic address: zanatta.rayssa@gmail.com.'}, {'ForeName': 'Tais', 'Initials': 'T', 'LastName': 'Scaramucci', 'Affiliation': 'Department of Restorative Dentistry, São Paulo University-USP, São Paulo, Brazil. Electronic address: tais.sca@usp.br.'}, {'ForeName': 'Idalina Vieira', 'Initials': 'IV', 'LastName': 'Aoki', 'Affiliation': 'Department of Chemical Engineering, Polytechnic School, São Paulo University-USP, São Paulo, Brazil. Electronic address: idavaoki@usp.br.'}, {'ForeName': 'Carlos Rocha Gomes', 'Initials': 'CRG', 'LastName': 'Torres', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: carlos.rg.torres@unesp.br.'}, {'ForeName': 'Alessandra Bühler', 'Initials': 'AB', 'LastName': 'Borges', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University-UNESP, São Paulo, Brazil. Electronic address: alessandra.buhler@unesp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103347']
160,30768418,A Randomized Controlled Trial: Attachment-Based Family and Nondirective Supportive Treatments for Youth Who Are Suicidal.,"OBJECTIVE


To evaluate the efficacy of attachment-based family therapy (ABFT) compared with a family-enhanced nondirective supportive therapy (FE-NST) for decreasing adolescents' suicide ideation and depressive symptoms.
METHOD


A randomized controlled trial of 129 adolescents who are suicidal ages 12- to 18-years-old (49% were African American) were randomized to ABFT (n = 66) or FE-NST (n = 63) for 16 weeks of treatment. Assessments occurred at baseline and 4, 8, 12, and 16 weeks. Trajectory of change and clinical recovery were calculated for suicidal ideation and depressive symptoms.
RESULTS


There was no significant between-group difference in the rate of change in self-reported ideation (Suicidal Ideation Questionnaire-Jr; F 1,127  = 181, p = .18). Similar results were found for depressive symptoms. However, adolescents receiving ABFT showed a significant decrease in suicide ideation (t 127  = 12.61, p < .0001; effect size, d = 2.24). Adolescents receiving FE-NST showed a similar significant decrease (t 127  = 10.88, p < .0001; effect size, d = 1.93). Response rates (ie, ≥50% decrease in suicide ideation symptoms from baseline) at post-treatment were 69.1% for ABFT versus 62.3% for FE-NST.
CONCLUSION


Contrary to expectations, ABFT did not perform better than FE-NST. The 2 treatments produced substantial decreases in suicidal ideation and depressive symptoms that were comparable to or better than those reported in other more intensive, multicomponent treatments. The equivalent outcomes could be attributed to common treatment elements, different active mechanisms, or regression to the mean. Future studies will explore long-term follow up, secondary outcomes, and potential moderators and mediators.
CLINICAL TRIAL REGISTRATION INFORMATION


Attachment-Based Family Therapy for Suicidal Adolescents; http://clinicaltrials.gov; NCT01537419.",2019,"Adolescents receiving FE-NST showed a similar significant decrease (t 127  = 10.88, p < .0001; effect size, d = 1.93).","['129 adolescents who are suicidal ages', ""adolescents' suicide ideation and depressive symptoms"", 'Youth', '12- to 18-years-old (49% were African American']","['family-enhanced nondirective supportive therapy (FE-NST', 'FE-NST', 'ABFT', 'attachment-based family therapy (ABFT']","['Response rates', 'suicidal ideation and depressive symptoms', 'depressive symptoms', 'suicide ideation symptoms', 'suicide ideation', 'rate of change in self-reported ideation (Suicidal Ideation Questionnaire']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015618', 'cui_str': 'Family Therapy'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",129.0,0.263649,"Adolescents receiving FE-NST showed a similar significant decrease (t 127  = 10.88, p < .0001; effect size, d = 1.93).","[{'ForeName': 'Guy S', 'Initials': 'GS', 'LastName': 'Diamond', 'Affiliation': 'Center for Family Intervention Science, Drexel University, Philadelphia, PA. Electronic address: guy.diamond@drexel.edu.'}, {'ForeName': 'R Roger', 'Initials': 'RR', 'LastName': 'Kobak', 'Affiliation': 'University of Delaware, Newark.'}, {'ForeName': 'E Stephanie', 'Initials': 'ES', 'LastName': 'Krauthamer Ewing', 'Affiliation': 'Center for Family Intervention Science, Drexel University, Philadelphia, PA.'}, {'ForeName': 'Suzanne A', 'Initials': 'SA', 'LastName': 'Levy', 'Affiliation': 'Center for Family Intervention Science, Drexel University, Philadelphia, PA.'}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Herres', 'Affiliation': 'The College of New Jersey, Ewing Township.'}, {'ForeName': 'Jody M', 'Initials': 'JM', 'LastName': 'Russon', 'Affiliation': 'Virginia Tech, Blacksburg.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gallop', 'Affiliation': 'Applied Statistics Program, West Chester University, PA.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.10.006']
161,32321385,"Effects of 8-week endurance and resistance training programmes on cardiovascular stress responses, life stress and coping.","This study tested the effect of 8-week endurance and resistance training programmes on cardiovascular stress responses, life stress, and coping. Fifty-two untrained but healthy female students were randomised to an 8-week endurance training, an 8-week resistance training, or a wait list control group. Before and after the training intervention, we assessed the groups' cardiorespiratory fitness (VO2max test), self-reported life stress, coping strategies and cardiovascular reactivity to and recovery from a standardised laboratory stressor. Both endurance and resistance training programmes caused physiological adaptation in terms of increased VO2max after the intervention. For stress and coping parameters, participants in the training groups improved cardiovascular recovery from stress and reported having less stress in their everyday life after the intervention than participants in the control group, while the two training groups did not differ from each other. We did not find any significant differences in heart rate reactivity and coping strategies between the study groups. These results partly support that exercise training has stress-reducing benefits regardless of the type of exercise. Both endurance and resistance exercise activities may be effectively used to improve stress regulation competence while having less impact on changing specific coping strategies.",2020,We did not find any significant differences in heart rate reactivity and coping strategies between the study groups.,['Fifty-two untrained but healthy female students'],"['exercise training', '8-week endurance training, an 8-week resistance training, or a wait list control group', '8-week endurance and resistance training programmes']","['cardiovascular stress responses, life stress and coping', 'heart rate reactivity and coping strategies', 'everyday life', 'cardiovascular stress responses, life stress, and coping', 'cardiovascular recovery', 'cardiorespiratory fitness (VO2max test), self-reported life stress, coping strategies and cardiovascular reactivity to and recovery from a standardised laboratory stressor']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",,0.0186328,We did not find any significant differences in heart rate reactivity and coping strategies between the study groups.,"[{'ForeName': 'Lukáš', 'Initials': 'L', 'LastName': 'Chovanec', 'Affiliation': 'Faculty of Physical Education and Sports, Comenius University in Bratislava , Bratislava, Slovakia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gröpel', 'Affiliation': 'Department of Applied Psychology, Work, Education, and Economy, University of Vienna , Vienna, Austria.'}]",Journal of sports sciences,['10.1080/02640414.2020.1756672']
162,32321714,"Safety, Efficacy, and Biomarker Analysis of Toripalimab in Previously Treated Advanced Melanoma: Results of the POLARIS-01 Multicenter Phase II Trial.","PURPOSE


In contrast to the predominant chronic UV exposure-induced cutaneous melanoma in Caucasians, acral and mucosal comprise the majority of melanomas in Asia and respond less effectively to established treatments. The clinical application of PD-1 blockade is yet to be explored in metastatic melanoma in China.
PATIENTS AND METHODS


This phase II study was to evaluate safety and efficacy of toripalimab in advanced Chinese patients with melanoma who had failed in systemic treatments. Toripalimab was given at 3 mg/kg i.v. once every 2 weeks until disease progression or unacceptable toxicity. The primary objective was safety and objective response rate.
RESULTS


128 Patients with melanoma were enrolled, including 50 acral and 22 mucosal. As of August 15, 2019, 23 months after the last enrollment, 116 (90.6%) experienced treatment-related adverse events. ≥Grade 3 TRAEs occurred in 25 (19.5%) patients. Among 127 patients assessed, 1 complete response, 21 partial response, and 51 stable disease were observed for objective response rate of 17.3% and disease control rate of 57.5%. Median duration of response was not reached. Median progression-free survival was 3.6 months [95% confidence interval (CI) 2.7-5.3] and median overall survival was 22.2 months (95% CI, 15.3-NE). Patients with positive PD-L1 staining in tumor biopsies had significant better ORR (38.5% vs. 11.9%,  P  = 0.0065), PFS (7.7 months vs. 2.7 months,  P  = 0.013), and OS (not reached vs. 14.4 months,  P  = 0.0005) than PD-L1-negative patients.
CONCLUSIONS


This is the largest prospective anti-PD-1 clinical study in advanced melanoma with predominantly acral and mucosal subtypes. Toripalimab demonstrated a manageable safety profile and durable clinical response in Chinese patients with metastatic melanoma refractory to standard therapy. See related commentary by Shoushtari et al., p. 4171 .",2020,"Patients with positive PD-L1 staining in tumor biopsies had significant better ORR (38.5% versus 11.9%, p=0.0065), PFS (7.7m versus 2.7m, p=0.013) and OS (not reached versus 14.4m, p=0.0005) than PD-L1 negative patients.
","['128 melanoma patients were enrolled, including 50 acral and 22 mucosal', 'previously treated advanced melanoma', 'advanced melanoma with predominantly acral and mucosal subtypes', 'advanced Chinese melanoma patients who had failed in systemic treatments', 'metastatic melanoma in China', 'Chinese patients with metastatic melanoma refractory to standard therapy']","['toripalimab', 'Toripalimab']","['OS', 'PFS', 'Median progression-free survival', 'treatment-related adverse events', '3 TRAEs', 'safety and objective response rate', 'safety and efficacy', 'ORR', 'median overall survival', 'Median duration of response', 'objective response rate', 'manageable safety profile and durable clinical response']","[{'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439746', 'cui_str': 'Acral'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],"[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.28348,"Patients with positive PD-L1 staining in tumor biopsies had significant better ORR (38.5% versus 11.9%, p=0.0065), PFS (7.7m versus 2.7m, p=0.013) and OS (not reached versus 14.4m, p=0.0005) than PD-L1 negative patients.
","[{'ForeName': 'Bixia', 'Initials': 'B', 'LastName': 'Tang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Chi', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital & Institute, Beijing, China.'}, {'ForeName': 'Yingbo', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiufeng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Nanjing Bayi Hospital, Nanjing, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Tumor Hospital of Yunnan Province & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center, Kunming, China.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'OrigiMed, Shanghai, China.'}, {'ForeName': 'Lihou', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': 'Department of Pharmacology and Toxicology, Beijing Institute of Radiation Medicine, Beijing, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Department of Pharmacology and Toxicology, Beijing Institute of Radiation Medicine, Beijing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': 'Shanghai Junshi Biosciences Co., LTD, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'Shanghai Junshi Biosciences Co., LTD, Shanghai, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'Shanghai Junshi Biosciences Co., LTD, Shanghai, China.'}, {'ForeName': 'Shuikui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': 'Nanjing Bayi Hospital, Nanjing, China.'}, {'ForeName': 'Xiaoshi', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Renal Cancer and Melanoma, Peking University Cancer Hospital & Institute, Beijing, China. guoj307@126.com.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3922']
163,31077790,A Randomized Controlled Study of Integrated Smoking Cessation in a Lung Cancer Screening Program.,"INTRODUCTION


Smoking cessation activities incorporated into lung cancer screening programs have been broadly recommended, but studies to date have not shown increased quit rates associated with cessation programs in this setting. We aimed to determine the effectiveness of smoking cessation counseling in smokers presenting for lung cancer screening.
METHODS


This study is a randomized control trial of an intensive telephone-based smoking cessation counseling intervention incorporating lung cancer screening results versus usual care (information pamphlet). All active smokers enrolled in the Alberta Lung Cancer Screening Study cohort were randomized on a 1:1 ratio with a primary endpoint of self-reported 30-day abstinence at 12 months.
RESULTS


A total of 345 active smokers participating in the screening study were randomized to active smoking cessation counseling (n = 171) or control arm (n = 174). Thirty-day smoking abstinence at 12 months post-randomization was noted in 22 of 174 (12.6%) and 24 of 171 (14.0%) of participants in the control and intervention arms, respectively, a 1.4% difference (95% confidence interval: -5.9 to 8.7, p = 0.7). No statistically significant differences in 7-day or point abstinence were noted, nor were differences at 6 months or 24 months.
CONCLUSIONS


A telephone-based smoking cessation counseling intervention incorporating lung cancer screening results did not result in increased 12-month cessation rates versus written information alone in unselected smokers undergoing lung cancer screening. Routine referral of all current smokers to counseling-based cessation programs may not improve long-term cessation in this patient cohort. Future studies should specifically focus on this subgroup of older long-term smokers to determine the optimal method of integrating smoking cessation with lung cancer screening (clinicaltrials.govNCT02431962).",2019,A telephone-based smoking cessation counseling intervention incorporating lung cancer screening results did not result in increased 12-month cessation rates versus written information alone in unselected smokers undergoing lung cancer screening.,"['All active smokers enrolled in the Alberta Lung Cancer Screening Study cohort', 'unselected smokers undergoing lung cancer screening', 'smokers presenting for lung cancer screening', '345 active smokers participating in the screening study']","['telephone-based smoking cessation counseling intervention', 'active smoking cessation counseling (n\xa0= 171) or control arm (n', 'smoking cessation counseling', 'intensive telephone-based smoking cessation counseling intervention', 'Integrated Smoking Cessation']","['12-month cessation rates', '30-day abstinence', '7-day or point abstinence']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001914', 'cui_str': 'Alberta'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",345.0,0.033317,A telephone-based smoking cessation counseling intervention incorporating lung cancer screening results did not result in increased 12-month cessation rates versus written information alone in unselected smokers undergoing lung cancer screening.,"[{'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Tremblay', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. Electronic address: alain.tremblay@ucalgary.ca.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Taghizadeh', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'AlbertaQuits Helpline, Health Links - Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kasowski', 'Affiliation': 'AlbertaQuits Helpline, Health Links - Alberta Health Services, Edmonton, Alberta, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'MacEachern', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Burrowes', 'Affiliation': 'Department of Diagnostic Imaging, Foothills Medical Center, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Graham', 'Affiliation': 'Department of Surgery, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Dickinson', 'Affiliation': 'Family Medicine and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Lam', 'Affiliation': 'Department of Integrative Oncology, The British Columbia Cancer Research Center, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Huiming', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Population, Public and Indigenous Health, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Rommy', 'Initials': 'R', 'LastName': 'Koetzler', 'Affiliation': 'Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tammemagi', 'Affiliation': 'Department of Medical Sciences, Brock University, St. Catharines, Ontario, Canada.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Taylor', 'Affiliation': 'Department of Oncology, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Eric L R', 'Initials': 'ELR', 'LastName': 'Bédard', 'Affiliation': 'Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.04.024']
164,31030946,A Mixed Lipid Emulsion Containing Fish Oil and Its Effect on Electrophysiological Brain Maturation in Infants of Extremely Low Birth Weight: A Secondary Analysis of a Randomized Clinical Trial.,"OBJECTIVE


To assess whether parenteral nutrition for infants of extremely low birth weight using a mixed lipid emulsion that contains fish oil influences electrophysiological brain maturation.
STUDY DESIGN


The study is a prespecified secondary outcome analysis of a randomized controlled trial of 230 infants of extremely low birth weight receiving a mixed (soybean oil, medium-chain triglycerides, olive oil, and fish oil; intervention) or a soybean oil-based lipid emulsion (control). The study was conducted at a single-level IV neonatal care unit (Medical University Vienna; June 2012 to October 2015). Electrophysiological brain maturation (background activity, sleep-wake cycling, and brain maturational scores) was assessed biweekly by amplitude-integrated electroencephalography (birth to discharge).
RESULTS


A total of 317 amplitude-integrated electroencephalography measurements (intervention: n = 165; control: n = 152) from 121 (intervention: n = 63; control: n = 58) of 230 infants of the core study were available for analysis. Demographic characteristics were not significantly different. By 28 weeks of postmenstrual age, infants receiving the intervention displayed significantly greater percentages of continuous background activity. Total maturational scores and individual scores for continuity, cycling, and bandwidth were significantly greater. Maximum maturational scores were reached 2 weeks earlier in the intervention group (36.4 weeks, 35.4-37.5) compared with the control group (38.4 weeks, 37.1-42.4) (median, IQR; P < .001).
CONCLUSIONS


Using a mixed parenteral lipid emulsion that contains fish oil, we found that electrophysiological brain maturation was accelerated in infants who were preterm.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01585935.",2019,"Total maturational scores and individual scores for continuity, cycling, and bandwidth were significantly greater.","['230 infants of extremely low birth weight receiving a', 'intervention: n\xa0=\xa063; control: n\xa0=\xa058) of 230 infants of the core study were available for analysis', 'infants of extremely low birth weight', 'infants who were preterm', 'single-level IV neonatal care unit (Medical University Vienna; June 2012 to October 2015', 'Infants of Extremely Low Birth Weight']","['mixed (soybean oil, medium-chain triglycerides, olive oil, and fish oil; intervention) or a soybean oil-based lipid emulsion (control', 'parenteral nutrition', '317 amplitude-integrated electroencephalography measurements (intervention: n\xa0=\xa0165; control: n\xa0=\xa0152) from 121', 'Mixed Lipid Emulsion Containing Fish Oil']","['electrophysiological brain maturation', 'Maximum maturational scores', 'Electrophysiological Brain Maturation', 'Electrophysiological brain maturation (background activity, sleep-wake cycling, and brain maturational scores', 'continuous background activity', 'Demographic characteristics', 'Total maturational scores and individual scores for continuity, cycling, and bandwidth']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0456065', 'cui_str': 'Infant, Extremely Low Birth Weight'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0724624', 'cui_str': 'Medium chain triglycerides'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0456391', 'cui_str': 'Continuities (qualifier value)'}]",230.0,0.377297,"Total maturational scores and individual scores for continuity, cycling, and bandwidth were significantly greater.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Binder', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Vito', 'Initials': 'V', 'LastName': 'Giordano', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Thanhaeuser', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kreissl', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Huber-Dangl', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Longford', 'Affiliation': 'Section of Neonatal Medicine, Department of Medicine; Imperial College London, Chelsea and Westminster Campus, London, United Kingdom.'}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Haiden', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Repa', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria. Electronic address: andreas.repa@meduniwien.ac.at.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Klebermass-Schrehof', 'Affiliation': 'Department of Pediatrics and Adolescent Medicine, Division of Neonatology, Pediatric Intensive Care Medicine and Neuropediatrics, Medical University of Vienna, Austria.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.03.039']
165,31618539,Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn.,"BACKGROUND


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


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


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


Among patients referred to VA gastroenterology clinics for PPI-refractory heartburn, systematic workup revealed truly PPI-refractory and reflux-related heartburn in a minority of patients. For that highly selected subgroup, surgery was superior to medical treatment. (Funded by the Department of Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT01265550.).",2019,"The incidence of treatment success with surgery (18 of 27 patients, 67%) was significantly superior to that with active medical treatment (7 of 25 patients, 28%; P = 0.007) or control medical treatment (3 of 26 patients, 12%; P<0.001).","['If patients were found to have reflux-related heartburn', '288 patients: 42 had relief of their heartburn during the 2-week omeprazole trial, 70 did not complete trial procedures, 54 were excluded for other reasons, 23 had non-GERD esophageal disorders, and 99 had functional heartburn (not due to GERD or other histopathologic, motility, or structural abnormality', '366 patients (mean age, 48.5 years; 280 men) were enrolled', 'patients referred to VA gastroenterology clinics for PPI-refractory heartburn', 'Patients who were referred to Veterans Affairs (VA) gastroenterology clinics for PPI-refractory heartburn received 20 mg of', 'twice daily for 2 weeks, and those with persistent heartburn underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance-pH monitoring']","['desipramine', 'omeprazole', 'proton-pump inhibitor (PPI', 'surgical treatment (laparoscopic Nissen fundoplication), active medical treatment (omeprazole plus baclofen, with desipramine added depending on symptoms), or control medical treatment (omeprazole plus placebo']","['Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life score', 'incidence of treatment success']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0014852', 'cui_str': 'Esophageal Diseases'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4302237', 'cui_str': 'Functional heartburn (disorder)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3834491', 'cui_str': 'Gastroenterology clinic (environment)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0192269', 'cui_str': 'Biopsy of esophagus (procedure)'}, {'cui': 'C0199873', 'cui_str': 'Esophageal manometry (procedure)'}, {'cui': 'C0442115', 'cui_str': 'Intraluminal (qualifier value)'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}]","[{'cui': 'C0011685', 'cui_str': 'Desipramine'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3887679', 'cui_str': 'Nissen Operation'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",288.0,0.117934,"The incidence of treatment success with surgery (18 of 27 patients, 67%) was significantly superior to that with active medical treatment (7 of 25 patients, 28%; P = 0.007) or control medical treatment (3 of 26 patients, 12%; P<0.001).","[{'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Spechler', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Hunter', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Jones', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Smith', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Mashimo', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Vivian M', 'Initials': 'VM', 'LastName': 'Sanchez', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Kerry B', 'Initials': 'KB', 'LastName': 'Dunbar', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Thai H', 'Initials': 'TH', 'LastName': 'Pham', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Uma K', 'Initials': 'UK', 'LastName': 'Murthy', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Taewan', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Jackson', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Wallen', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Erik C', 'Initials': 'EC', 'LastName': 'von Rosenvinge', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Pearl', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Loren', 'Initials': 'L', 'LastName': 'Laine', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Anthony W', 'Initials': 'AW', 'LastName': 'Kim', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Kaz', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Roger P', 'Initials': 'RP', 'LastName': 'Tatum', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Ziad F', 'Initials': 'ZF', 'LastName': 'Gellad', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Lagoo-Deenadayalan', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Joel H', 'Initials': 'JH', 'LastName': 'Rubenstein', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Amir A', 'Initials': 'AA', 'LastName': 'Ghaferi', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Wai-Kit', 'Initials': 'WK', 'LastName': 'Lo', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Fernando', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Bobby S', 'Initials': 'BS', 'LastName': 'Chan', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Shirley C', 'Initials': 'SC', 'LastName': 'Paski', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Provenzale', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Donald O', 'Initials': 'DO', 'LastName': 'Castell', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lieberman', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Rhonda F', 'Initials': 'RF', 'LastName': 'Souza', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Chey', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Warren', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Davis-Karim', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Shelby D', 'Initials': 'SD', 'LastName': 'Melton', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Genta', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Serpi', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Kousick', 'Initials': 'K', 'LastName': 'Biswas', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Huang', 'Affiliation': 'From the Department of Medicine and Center for Esophageal Diseases, Baylor University Medical Center at Dallas, Baylor Scott & White Health, and the Department of Medicine, Veterans Affairs (VA) North Texas Health Care System (S.J.S., R.F.S.), and the Departments of Medicine (K.B.D.), Surgery (T.H.P.), and Pathology (S.D.M.), VA North Texas Health Care System and University of Texas Southwestern Medical Center, Dallas, and the Department of Pathology, Baylor College of Medicine, Houston (R.M.G.); the Departments of Surgery (J.G.H.) and Medicine (D.L.), Oregon Health and Science University, and the Department of Medicine, VA Portland Health Care System (D.L.) - both in Portland; the VA Cooperative Studies Program Coordinating Center, Perry Point (K.M.J., T.S., K.B.), and the Departments of Medicine (E.C.R.) and Surgery (J.P.P.), VA Maryland Health Care System and University of Maryland School of Medicine, Baltimore - all in Maryland; the Departments of Medicine (R.L.) and Surgery (B.R.S.), VA Long Beach Healthcare System and University of California, Irvine, Irvine, the Departments of Medicine (C.S.J., R.S.F., B.S.C.) and Surgery (J.M.W.), VA Loma Linda Healthcare System and Loma Linda University Medical Center, Loma Linda, and the Department of Surgery, University of Southern California, Los Angeles (A.W.K.) - all in California; the Department of Medicine, VA Boston Healthcare System, Harvard Medical School (H.M., W.-K.L.), and the Department of Surgery, VA Boston Healthcare System, Boston University School of Medicine (V.M.S.), Boston; the Departments of Medicine (U.K.M.) and Surgery (T.K.), Syracuse VA Medical Center and SUNY Upstate Medical University, Syracuse, NY; the Department of Medicine, VA Connecticut Healthcare System and Yale University, New Haven, CT (L.L.); the Departments of Medicine (A.M.K., S.C.P.) and Surgery (R.P.T.), VA Puget Sound Health Care System and University of Washington School of Medicine, Seattle; the Departments of Medicine (Z.F.G., D.P.) and Surgery (S.L.-D.), Durham VA Medical Center and Duke University Medical Center, Durham, NC; the Departments of Medicine (J.H.R.) and Surgery (A.A.G.), VA Ann Arbor Healthcare System, and the Departments of Medicine (J.H.R., W.D.C.) and Surgery (A.A.G.), University of Michigan - both in Ann Arbor; the Department of Medicine, Medical University of South Carolina, Charleston (D.O.C.); the VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (S.R.W., A.D.-K.); and the VA Office of Research and Development, Washington, DC (G.D.H.).'}]",The New England journal of medicine,['10.1056/NEJMoa1811424']
166,32299284,Impact of a Copayment Reduction Intervention on Medication Persistence and Cardiovascular Events in Hospitals With and Without Prior Medication Financial Assistance Programs.,"Background Hospitals commonly provide a short-term supply of free P2Y 12  inhibitors at discharge after myocardial infarction, but it is unclear if these programs improve medication persistence and outcomes. The ARTEMIS (Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study) trial randomized hospitals to usual care versus waived P2Y 12  inhibitor copayment costs for 1-year post-myocardial infarction. Whether the impact of this intervention differed between hospitals with and without pre-existing medication assistance programs is unknown. Methods and Results In this post hoc analysis of the ARTEMIS trial, we examined the associations of pre-study free medication programs and the randomized copayment voucher intervention with P2Y 12  inhibitor persistence (measured by pharmacy fills and patient report) and major adverse cardiovascular events using logistic regression models including a propensity score. Among 262 hospitals, 129 (49%) offered pre-study free medication assistance. One-year P2Y 12  inhibitor persistence and major adverse cardiovascular events risks were similar between patients treated at hospitals with and without free medication programs (adjusted odds ratio 0.93, 95% CI, 0.82-1.05 and hazard ratio 0.92, 95% CI, 0.80-1.07, respectively). The randomized copayment voucher intervention improved persistence, assessed by pharmacy fills, in both hospitals with (53.6% versus 44.0%, adjusted odds ratio 1.45, 95% CI, 1.20-1.75) and without (59.0% versus 48.3%, adjusted odds ratio 1.46, 95% CI, 1.25-1.70) free medication programs ( P interaction =0.71). Differences in patient-reported persistence were not significant after adjustment. Conclusions While hospitals commonly report the ability to provide free short-term P2Y 12  inhibitors, we did not find association of this with medication persistence or major adverse cardiovascular events among patients with insurance coverage for prescription medication enrolled in the ARTEMIS trial. An intervention that provided copayment assistance vouchers for 1 year was successful in improving medication persistence in hospitals with and without pre-existing short-term medication programs. Registration URL: https://www.clini​caltr​ials.gov/. Unique identifier: NCT02406677.",2020,"One-year P2Y 12  inhibitor persistence and major adverse cardiovascular events risks were similar between patients treated at hospitals with and without free medication programs (adjusted odds ratio 0.93, 95% CI, 0.82-1.05 and hazard ratio 0.92, 95% CI, 0.80-1.07, respectively).","['Hospitals', '262 hospitals, 129 (49%) offered pre-study free medication assistance', 'patients with insurance coverage for prescription medication enrolled']","['Copayment Reduction Intervention', 'Registration URL', 'usual care versus waived P2Y 12  inhibitor copayment costs']","['inhibitor persistence and major adverse cardiovascular events risks', 'Medication Persistence and Cardiovascular Events']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1273410', 'cui_str': 'Cardiovascular event risk'}, {'cui': 'C2350288', 'cui_str': 'Medication Persistence'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.178778,"One-year P2Y 12  inhibitor persistence and major adverse cardiovascular events risks were similar between patients treated at hospitals with and without free medication programs (adjusted odds ratio 0.93, 95% CI, 0.82-1.05 and hazard ratio 0.92, 95% CI, 0.80-1.07, respectively).","[{'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Doll', 'Affiliation': 'VA Puget Sound Health Care System Seattle WA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kaltenbach', 'Affiliation': 'Duke Clinical Research Institute Durham NC.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute Durham NC.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': 'The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital Cincinnati OH.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'University of California-Los Angeles CA.'}, {'ForeName': 'Niteesh K', 'Initials': 'NK', 'LastName': 'Choudhry', 'Affiliation': ""Center for Healthcare Delivery Sciences Brigham and Women's Hospital and Harvard Medical School Boston MA.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Fonseca', 'Affiliation': 'AstraZeneca Wilmington DE.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Bhalla', 'Affiliation': 'AstraZeneca Wilmington DE.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Eudicone', 'Affiliation': 'AstraZeneca Wilmington DE.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke University Durham NC.'}, {'ForeName': 'Tracy Y', 'Initials': 'TY', 'LastName': 'Wang', 'Affiliation': 'Duke University Durham NC.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014975']
167,32306797,Pharmacodynamic Effects of Vorapaxar in Prior Myocardial Infarction Patients Treated With Potent Oral P2Y 12  Receptor Inhibitors With and Without Aspirin: Results of the VORA-PRATIC Study.,"Background Vorapaxar as an adjunct to dual antiplatelet therapy (DAPT) reduces thrombotic events in patients with prior myocardial infarction at the expense of increased bleeding. Withdrawal of aspirin has emerged as a bleeding reduction strategy. The pharmacodynamic effects of vorapaxar with potent P2Y 12  inhibitors as well as the impact of dropping aspirin is unexplored and represented the aim of the VORA-PRATIC (Vorapaxar Therapy in Patients With Prior Myocardial Infarction Treated With Newer Generation P2Y 12  Receptor Inhibitors Prasugrel and Ticagrelor) study. Methods and Results Post-myocardial infarction patients (n=130) on standard DAPT (aspirin+prasugrel or ticagrelor) were randomized to 1 of 3 arms: (1) triple therapy: aspirin+prasugrel/ticagrelor+vorapaxar; (2) dual therapy (drop aspirin): prasugrel/ticagrelor+vorapaxar; (3) DAPT: aspirin+prasugrel/ticagrelor. Pharmacodynamic assessments were performed at 3 time points (baseline and 7 and 30 days). Vorapaxar reduced CAT (collagen-ADP-TRAP)-induced platelet aggregation, a marker of platelet-mediated global thrombogenicity (triple therapy versus DAPT at 30 days: mean difference=-27; 95% CI,-35 to -19;  P <0.001; primary end point). This effect was attenuated but still significant in the absence of aspirin (dual therapy versus DAPT at 30 days: mean difference=-15; 95% CI,-23 to -7;  P <0.001; between-group comparisons,  P <0.05). Vorapaxar abolished TRAP-induced aggregation ( P <0.001), without affecting thrombin generation and clot strength. There were no differences in markers of P2Y 12  reactivity. Markers sensitive to aspirin-induced effects increased ( P <0.001) in the dual-therapy arm. Conclusions In post-myocardial infarction patients treated with potent P2Y 12  inhibitors, vorapaxar reduces platelet-driven global thrombogenicity, an effect that persisted, albeit attenuated, in the absence of aspirin and without affecting markers of P2Y 12  reactivity or clot kinetics. The clinical implications of these PD observations warrant future investigation. Registration URL: https://www.clini​caltr​ials.gov. Unique identifier: NCT02545933.",2020,"Vorapaxar abolished TRAP-induced aggregation ( P <0.001), without affecting thrombin generation and clot strength.","['Patients', 'Prior Myocardial Infarction Patients Treated With Potent Oral P2Y 12  Receptor Inhibitors With and Without', 'patients with prior myocardial infarction']","['aspirin', 'Vorapaxar', 'dual antiplatelet therapy (DAPT', 'triple therapy: aspirin+prasugrel/ticagrelor+vorapaxar; (2) dual therapy (drop aspirin): prasugrel/ticagrelor+vorapaxar; (3) DAPT: aspirin+prasugrel/ticagrelor', 'standard DAPT (aspirin+prasugrel or ticagrelor', 'Aspirin']","['platelet-driven global thrombogenicity', 'thrombin generation and clot strength', 'Vorapaxar reduced CAT (collagen-ADP-TRAP)-induced platelet aggregation, a marker of platelet-mediated global thrombogenicity', 'thrombotic events', 'Vorapaxar abolished TRAP-induced aggregation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C2974521', 'cui_str': 'vorapaxar'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0009074', 'cui_str': 'Clotrimazole'}, {'cui': 'C2974521', 'cui_str': 'vorapaxar'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C1271704', 'cui_str': 'Collagen ADP'}, {'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}, {'cui': 'C1268819', 'cui_str': 'Induced platelet aggregation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}]",,0.0571621,"Vorapaxar abolished TRAP-induced aggregation ( P <0.001), without affecting thrombin generation and clot strength.","[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Franchi', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Rollini', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Faz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Jose Ramon', 'Initials': 'JR', 'LastName': 'Rivas', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rivas', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Malhar', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Maryuri', 'Initials': 'M', 'LastName': 'Briceno', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Wali', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Nawaz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Silva', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Zubair', 'Initials': 'Z', 'LastName': 'Shaikh', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Maaliki', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Kerolos', 'Initials': 'K', 'LastName': 'Fahmi', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Latonya', 'Initials': 'L', 'LastName': 'Been', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Pineda', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Siva', 'Initials': 'S', 'LastName': 'Suryadevara', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Soffer', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'Zenni', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai New York NY.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute Icahn School of Medicine at Mount Sinai New York NY.'}, {'ForeName': 'Lisa K', 'Initials': 'LK', 'LastName': 'Jennings', 'Affiliation': 'CirQuest Labs Memphis TN.'}, {'ForeName': 'Theodore A', 'Initials': 'TA', 'LastName': 'Bass', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine-Jacksonville FL.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.015865']
168,31271885,Effect of Sirolimus on Immune Reconstitution Following Myeloablative Allogeneic Stem Cell Transplantation: An Ancillary Analysis of a Randomized Controlled Trial Comparing Tacrolimus/Sirolimus and Tacrolimus/Methotrexate (Blood and Marrow Transplant Clinical Trials Network/BMT CTN 0402).,"Although allogeneic hematopoietic cell transplantation (HCT) is a potentially curative therapy for hematologic neoplasms, one of its limiting toxicities continues to be graft-versus-host disease, both acute (aGVHD) and chronic (cGVHD). Sirolimus is a mammalian target of rapamycin inhibitor that has proven effective in GVHD prophylaxis in combination with a calcineurin inhibitor, such as tacrolimus. The impact of sirolimus on immune reconstitution has not been comprehensively investigated in vivo thus far, however. Here we present an ancillary analysis of the randomized study BMT-CTN 0402 that examined the effect of sirolimus on immune subsets post-transplantation. We further examine the association between different lymphocyte subsets and outcomes post-transplantation in each arm. BMT-CTN 0402 was a randomized trial (n = 304) comparing 2 GVHD prophylaxis regimens, tacrolimus/sirolimus (Tac/Sir) and tacrolimus/methotrexate (Tac/MTX), in patients with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome undergoing myeloablative HLA-matched HCT. There were no differences in 114-day GVHD-free survival (primary endpoint), aGVHD, cGVHD, relapse, or overall survival (OS) between the 2 arms. Of the 304 patients, 264 had available samples for the current immune reconstitution analysis. Blood samples were collected at 1, 3, 6, 12, and 24 months post-HCT. Multiparameter flow cytometry was performed at the project laboratory (Esoterix Clinical Trials Services) in a blinded fashion, and results for the 2 arms were compared. Multivariable Cox regression models, treating each phenotypic parameter as a time-dependent variable, were constructed to study the impact of reconstitution on clinical outcomes. There were no significant differences in patient and transplantation characteristics between the Tac/Sir and Tac/MTX arms in this analysis. Absolute lymphocyte count and CD3 +  cell, CD4 +  cell, and conventional T cell (Tcon) counts were significantly decreased in the Tac/Sir arm for up to 3 months post-HCT, whereas CD8 +  cells recovered even more slowly (up to 6 months) in this arm. Interestingly, there was no clear difference in the absolute number of regulatory T cells (Tregs, defined as CD4 + CD25 +  cells) between the 2 arms at any point post-HCT; however, the Treg:Tcon ratio was significantly greater in the Tac/Sir arm in the first 3 months after HCT. B lymphocyte recovery was significantly compromised in the Tac/Sir arm from 1 month to 6 months after HCT, whereas natural killer cell reconstitution was not affected in the Tac/Sir arm. In the outcomes analysis, higher numbers of CD3 +  cells, CD4 +  cells, CD8 +  cells, and Tregs were associated with better OS. Neither Treg numbers nor the Treg:Tcon ratio was correlated with GVHD. Our findings indicate that Tac/Sir has a more profound T cell suppressive effect than the combination of Tac/MTX in the early post-transplantation period, and particularly compromises the recovery of CD8 +  T cells, which have been implicated in aGVHD. Sirolimus used in vivo with tacrolimus does not appear to result in increased absolute numbers of Tregs, but might have a beneficial effect on the Treg:Tcon balance in the first 3 months after transplantation. Nonetheless, no differences in aGVHD or cGVHD between the 2 arms were observed in the parent randomized trial. Calcineurin-inhibitor free, sirolimus-containing GVHD prophylaxis strategies, incorporating other novel agents, should be investigated further to maximize the potential favorable effect of sirolimus on Treg:Tcon balance in the post-transplantation immune repertoire. Sirolimus significantly compromises B cell recovery in the first 6 months post-HCT, with potential complex effects on cGVHD that merit further study.",2019,"There was no difference in 114-day GVHD free survival (primary endpoint) as well as acute or chronic GVHD, relapse or overall survival between arms.","['myeloablative allogeneic stem-cell transplantation', '264/304 patients had available samples for the current immune reconstitution analysis']","['sirolimus', 'Sirolimus', 'tacrolimus', 'calcineurin inhibitors like tacrolimus', 'rapamycin (mTOR) inhibitor', 'myeloablative HLA-matched transplantation', 'GVHD prophylaxis regimens, tacrolimus/sirolimus (Tac/Sir) versus tacrolimus/methotrexate (Tac/MTX', 'Tacrolimus/Sirolimus with Tacrolimus/Methotrexate', 'Tac/MTX', 'allogeneic hematopoietic cell transplantation (HCT']","['NK cells reconstitution', 'absolute number of regulatory T-cells', '114-day GVHD free survival', 'Blood samples', 'immune reconstitution', 'compromises B-cell recovery', 'patient and transplant characteristics', 'Absolute lymphocyte count (ALC), CD3+, CD4+ and conventional T cell counts', 'higher numbers of CD3+, CD4', 'aGVHD or cGVHD', 'B-lymphocyte recovery', 'overall survival', 'acute or chronic GVHD, relapse or overall survival']","[{'cui': 'C2242529', 'cui_str': 'Allogenic stem cell transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4505207', 'cui_str': 'Immune Regeneration'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C4521884', 'cui_str': 'Calcineurin inhibitor (disposition)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0242966', 'cui_str': 'Sepsis Syndrome'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]","[{'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C4505207', 'cui_str': 'Immune Regeneration'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0867389', 'cui_str': 'Chronic graft-versus-host disease (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.0394254,"There was no difference in 114-day GVHD free survival (primary endpoint) as well as acute or chronic GVHD, relapse or overall survival between arms.","[{'ForeName': 'Mahasweta', 'Initials': 'M', 'LastName': 'Gooptu', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts. Electronic address: mahasweta_gooptu@dfci.harvard.edu.'}, {'ForeName': 'Haesook T', 'Initials': 'HT', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Howard', 'Affiliation': 'Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota.'}, {'ForeName': 'Sung W', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Blood and Marrow Transplantation Program, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Soiffer', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Joseph H', 'Initials': 'JH', 'LastName': 'Antin', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Ritz', 'Affiliation': ""Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Corey S', 'Initials': 'CS', 'LastName': 'Cutler', 'Affiliation': 'Division of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, Massachusetts.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2019.06.029']
169,32311911,Vascular effects of physical activity are not modified by short-term inhaled diesel exhaust: Results of a controlled human exposure study.,"BACKGROUND


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


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


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


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


Acute physical activity induces a vasodilatory response in the micro- and macrovasculature in healthy adults by increasing CRAE and CRVE, and by reducing systolic BP post exercise, despite breathing DE. The DE-associated increase in HR might be indicative of an increased sympathetic response to physical activity while breathing DE.",2020,"Heart rate at T 2  was significantly increased by 3 bpm (2, 3 bpm, p = 0.025) after the DE-exposure when compared to FA.
","['individuals with exercise-induced bronchoconstriction', 'healthy adults', 'eighteen adults inhaled either 400\xa0μg of the β 2']","['physical activity and air pollution exposure', 'agonist use while breathing diesel exhaust (DE', 'inhaled filtered air (FA) or DE', 'agonist salbutamol or placebo']","['Heart rate at T 2', 'CRVE', 'systolic BP', 'Microvascular (central retinal arteriolar and venular equivalents, CRAE and CRVE, respectively) and macrovascular parameters (blood pressure (BP)) and heart rate (HR', 'cycling bout increased CRAE ', 'vasodilatory response', 'CRAE (FA-DE difference']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0079043', 'cui_str': 'Bronchial Constriction'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C3816746', 'cui_str': '400'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0012151', 'cui_str': 'Diesel Exhaust'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0731566,"Heart rate at T 2  was significantly increased by 3 bpm (2, 3 bpm, p = 0.025) after the DE-exposure when compared to FA.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Koch', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, 6081 University Boulevard, Vancouver, British Columbia, V6T 1Z1, Canada. Electronic address: sarahkoch@alumni.ubc.ca.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Zelembaba', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, 6081 University Boulevard, Vancouver, British Columbia, V6T 1Z1, Canada.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Tran', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, 6081 University Boulevard, Vancouver, British Columbia, V6T 1Z1, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Laeremans', 'Affiliation': 'Health Unit, Flemish Institute for Technological Research (VITO), Boeretang 200, 2400 Mol, Antwerp, Belgium; Centre for Environmental Sciences, Agoralaan building D, 3590 Diepenbeek, Belgium.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hives', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, 6081 University Boulevard, Vancouver, British Columbia, V6T 1Z1, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Carlsten', 'Affiliation': 'Faculty of Medicine, University of British Columbia, 2329 West Mall, Vancouver, British Columbia, V6T 1Z4, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'De Boever', 'Affiliation': 'Health Unit, Flemish Institute for Technological Research (VITO), Boeretang 200, 2400 Mol, Antwerp, Belgium; Centre for Environmental Sciences, Agoralaan building D, 3590 Diepenbeek, Belgium.'}, {'ForeName': 'Michael Stephen', 'Initials': 'MS', 'LastName': 'Koehle', 'Affiliation': 'School of Kinesiology, University of British Columbia, Vancouver, 6081 University Boulevard, Vancouver, British Columbia, V6T 1Z1, Canada; Faculty of Medicine, University of British Columbia, 2329 West Mall, Vancouver, British Columbia, V6T 1Z4, Canada.'}]",Environmental research,['10.1016/j.envres.2020.109270']
170,32312713,Randomized Phase IIB Trial of the Lignan Secoisolariciresinol Diglucoside in Premenopausal Women at Increased Risk for Development of Breast Cancer.,"We conducted a multiinstitutional, placebo-controlled phase IIB trial of the lignan secoisolariciresinol diglucoside (SDG) found in flaxseed. Benign breast tissue was acquired by random periareolar fine needle aspiration (RPFNA) from premenopausal women at increased risk for breast cancer. Those with hyperplasia and ≥2% Ki-67 positive cells were eligible for randomization 2:1 to 50 mg SDG/day (Brevail) versus placebo for 12 months with repeat bio-specimen acquisition. The primary endpoint was difference in change in Ki-67 between randomization groups. A total of 180 women were randomized, with 152 ultimately evaluable for the primary endpoint. Median baseline Ki-67 was 4.1% with no difference between arms. Median Ki-67 change was -1.8% in the SDG arm ( P  = 0.001) and -1.2% for placebo ( P  = 0.034); with no significant difference between arms. As menstrual cycle phase affects proliferation, secondary analysis was performed for 117 women who by progesterone levels were in the same phase of the menstrual cycle at baseline and off-study tissue sampling. The significant Ki-67 decrease persisted for SDG (median = -2.2%;  P  = 0.002) but not placebo (median = -1.0%). qRT-PCR was performed on 77 pairs of tissue specimens. Twenty-two had significant ERα gene expression changes (<0.5 or >2.0) with 7 of 10 increases in placebo and 10 of 12 decreases for SDG ( P  = 0.028), and a difference between arms ( P  = 0.017). Adverse event incidence was similar in both groups, with no evidence that 50 mg/day SDG is harmful. Although the proliferation biomarker analysis showed no difference between the treatment group and the placebo, the trial demonstrated use of SDG is tolerable and safe.",2020,Median Ki-67 change was -1.8% in the SDG arm (P=0.001) and -1.2% for placebo (P=0.034); with no significant difference between arms.,"['Pre-menopausal Women at Increased Risk for Development of Breast Cancer', '117 women who by progesterone levels', '180 women were randomized, with 152 ultimately evaluable for the primary endpoint', 'Those with hyperplasia and ≥2% Ki-67 positive cells']","['SDG', 'RT-qPCR', 'Lignan Secoisolariciresinol Diglucoside', 'random periareolar fine needle aspiration (RPFNA', 'lignan secoisolariciresinol diglucoside (SDG', 'placebo']","['SDG', 'change in Ki-67', 'Adverse event incidence', 'ERα gene expression changes', 'Median Ki-67 change', 'Median baseline Ki-67']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}]","[{'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0064971', 'cui_str': 'Lignans'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",180.0,0.408017,Median Ki-67 change was -1.8% in the SDG arm (P=0.001) and -1.2% for placebo (P=0.034); with no significant difference between arms.,"[{'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Fabian', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Seema A', 'Initials': 'SA', 'LastName': 'Khan', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Judy E', 'Initials': 'JE', 'LastName': 'Garber', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Dooley', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Yee', 'Affiliation': 'Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Klemp', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Nydegger', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Kandy R', 'Initials': 'KR', 'LastName': 'Powers', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Kreutzjans', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Carola M', 'Initials': 'CM', 'LastName': 'Zalles', 'Affiliation': 'Department of Pathology, Boca Raton Hospital, Boca Raton, Florida.'}, {'ForeName': 'Trina', 'Initials': 'T', 'LastName': 'Metheny', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Phillips', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jinxiang', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Devin C', 'Initials': 'DC', 'LastName': 'Koestler', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Prabhakar', 'Initials': 'P', 'LastName': 'Chalise', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Nanda Kumar', 'Initials': 'NK', 'LastName': 'Yellapu', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Jernigan', 'Affiliation': 'University of Kansas Cancer Center, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Petroff', 'Affiliation': 'Veterinary Diagnostic Laboratory, Michigan State University, Lansing, Michigan.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Hursting', 'Affiliation': 'Department of Nutrition, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Kimler', 'Affiliation': 'Department of Radiation Oncology, University of Kansas Medical Center, Kansas City, Kansas. bkimler@kumc.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0050']
171,30650259,"A Phase 1 Study of Intravenous Plazomicin in Healthy Adults to Assess Potential Effects on the QT/QTc Interval, Safety, and Pharmacokinetics.","Plazomicin is an aminoglycoside with in vitro activity against multidrug-resistant Enterobacteriaceae. A phase 1, randomized, double-blind, crossover study assessed the potential effects of plazomicin on cardiac repolarization (NCT01514929). Fifty-six healthy adults (24 men, 32 women) received a single therapeutic dose of plazomicin (15 mg/kg administered by 30-minute intravenous infusion), a single supratherapeutic dose of plazomicin (20 mg/kg administered by 30-minute intravenous infusion), placebo, or oral moxifloxacin (400 mg). The primary end point was the baseline-adjusted, placebo-corrected QTc interval using the Fridericia formula (ΔΔQTcF). Assay sensitivity was concluded if the lower limit of a 1-sided 95%CI (adjusted for multiplicity using the Hochberg procedure) for moxifloxacin ΔΔQTcF was >5 milliseconds at ≥1 prespecified time points. No QT prolongation effect for plazomicin was concluded if the largest mean effect was <5 milliseconds, and the upper limit of a 2-sided 90%CI for plazomicin ΔΔQTcF was <10 milliseconds at all time points. Assay sensitivity was demonstrated based on moxifloxacin ΔΔQTcF. No QT prolongation effect for plazomicin was concluded because the largest mean ΔΔQTcF for plazomicin was 3.5 milliseconds, and the highest upper limit was 5.6 milliseconds. No clinically relevant changes were observed in electrocardiograms. For the 15- and 20-mg/kg dose levels of plazomicin, mean peak plasma concentration values were 76.0 and 96.6 mg/L, and mean values of the area under the concentration-time curve over 24 hours were 263 and 327 mg·h/L, respectively. Model-derived pharmacokinetic parameters and safety findings were generally consistent with previously reported plazomicin studies. In conclusion, therapeutic and supratherapeutic doses of plazomicin had no clinically significant effect on cardiac repolarization and were generally well tolerated.",2019,"Assay sensitivity was demonstrated based on moxifloxacin ΔΔQTcF. No QT prolongation effect for plazomicin was concluded because the largest mean ΔΔQTcF for plazomicin was 3.5 milliseconds, and the highest upper limit was 5.6 milliseconds.","['Fifty-six healthy adults (24 men, 32 women', 'Healthy Adults']","['supratherapeutic dose of plazomicin', 'Plazomicin', 'placebo, or oral moxifloxacin', 'single therapeutic dose of plazomicin', 'plazomicin', 'moxifloxacin ΔΔQTcF', 'Intravenous Plazomicin']","['Assay sensitivity', 'QT/QTc Interval, Safety, and Pharmacokinetics', 'tolerated', 'cardiac repolarization', 'plazomicin, mean peak plasma concentration values', 'baseline-adjusted, placebo-corrected QTc interval using the Fridericia formula (ΔΔQTcF']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3502652', 'cui_str': 'plazomicin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C3502652', 'cui_str': 'plazomicin'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",56.0,0.203704,"Assay sensitivity was demonstrated based on moxifloxacin ΔΔQTcF. No QT prolongation effect for plazomicin was concluded because the largest mean ΔΔQTcF for plazomicin was 3.5 milliseconds, and the highest upper limit was 5.6 milliseconds.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Gall', 'Affiliation': 'Achaogen, Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Choi', 'Affiliation': 'Achaogen, Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Riddle', 'Affiliation': 'BioPharmAdvisors LLC, Parrish, FL, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Van Wart', 'Affiliation': 'Institute for Clinical Pharmacodynamics, Schenectady, NY, USA.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Gibbons', 'Affiliation': 'Achaogen, Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Seroogy', 'Affiliation': 'Achaogen, Inc, South San Francisco, CA, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.653']
172,30650260,"Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of ELX-02, a Potential Treatment for Genetic Disorders Caused by Nonsense Mutations, in Healthy Volunteers.","ELX-02 is an investigational synthetic eukaryotic ribosome-selective glycoside optimized as a translational read-through molecule that induces read through of nonsense mutations, resulting in normally localized full-length functional proteins. ELX-02 is being developed as a therapy for genetic diseases caused by nonsense mutations. Two phase 1a, randomized, double-blind placebo-controlled, single-ascending-dose studies were conducted in healthy human subjects to evaluate the safety and pharmacokinetics of ELX-02. Single subcutaneously injected doses of ELX-02 between 0.3 mg/kg and 7.5 mg/kg showed an acceptable safety profile without severe or serious drug-related adverse events, including a lack of renal and ototoxicity events. Injection of ELX-02 resulted in a rapid time to peak concentration and elimination phase, with complete elimination from the vascular compartment within 10 hours. ELX-02 area under the concentration-time curve to infinity showed dose-exposure linearity (24-fold increase for a 25-fold dose increase), and the maximum concentration showed dose proportionality (17-fold increase for a 25-fold increase). The mean apparent volume of distribution was dose dependent, suggesting an increased distribution and tissue uptake of ELX-02 at higher doses. The primary route of excretion was in the urine, with the majority of the compound excreted unchanged. These results support the evaluation of the safety, pharmacokinetics, and efficacy of repeat dosing in future studies.",2019,"The mean apparent volume of distribution was dose dependent, suggesting an increased distribution and tissue uptake of ELX-02 at higher doses.","['Healthy Volunteers', 'healthy human subjects']","['ELX-02', 'placebo']","['renal and ototoxicity events', 'acceptable safety profile without severe or serious drug-related adverse events', 'Safety, Tolerability, and Pharmacokinetics', 'ELX-02 area under the concentration-time curve', 'safety and pharmacokinetics of ELX-02', 'distribution and tissue uptake of ELX-02']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0235280', 'cui_str': 'Ototoxicity (disorder)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]",,0.172092,"The mean apparent volume of distribution was dose dependent, suggesting an increased distribution and tissue uptake of ELX-02 at higher doses.","[{'ForeName': 'Andi', 'Initials': 'A', 'LastName': 'Leubitz', 'Affiliation': 'Eloxx Pharmaceuticals, Rehovot, Israel.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Frydman-Marom', 'Affiliation': 'Eloxx Pharmaceuticals, Rehovot, Israel.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Sharpe', 'Affiliation': 'Eloxx Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'van Duzer', 'Affiliation': 'Eloxx Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Kathleen C M', 'Initials': 'KCM', 'LastName': 'Campbell', 'Affiliation': 'Audiology consultant to Eloxx Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Vanhoutte', 'Affiliation': 'SGS Life Sciences, Clinical Pharmacology Unit, Antwerp, Belgium.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.647']
173,32083766,"Postoperative Radiotherapy in Pathological T2-3N0M0 Thoracic Esophageal Squamous Cell Carcinoma: Interim Report of a Prospective, Phase III, Randomized Controlled Study.","BACKGROUND


The role of postoperative radiotherapy in pathological T2-3N0M0 esophageal squamous cell carcinoma is unknown. We aimed to evaluate the efficacy and safety of postoperative radiotherapy in patients with pathological T2-3N0M0 thoracic esophageal squamous cell carcinoma.
MATERIALS AND METHODS


Patients aged 18-72 years with pathological stage T2-3N0M0 esophageal squamous cell carcinoma after radical surgery and without neoadjuvant therapy were eligible. Patients were randomly assigned to surgery alone or to receive postoperative radiotherapy of 50.4 Gy in supraclavicular field and 56 Gy in mediastinal field in 28 fractions over 6 weeks. The primary endpoint was disease-free survival. The secondary endpoints were local-regional recurrence rate, overall survival, and radiation-related toxicities.
RESULTS


From October 2012 to February 2018, 167 patients were enrolled in this study. We analyzed 157 patients whose follow-up time was more than 1 year or who had died. The median follow-up time was 45.6 months. The 3-year disease-free survival rates were 75.1% (95% confidence interval [CI] 65.9-85.5) in the postoperative radiotherapy group and 58.7% (95% CI 48.2-71.5) in the surgery group (hazard ratio 0.53, 95% CI 0.30-0.94, p = .030). Local-regional recurrence rate decreased significantly in the radiotherapy group (10.0% vs. 32.5% in the surgery group, p = .001). The overall survival and distant metastasis rates were not significantly different between two groups. Grade 3 toxicity rate related to radiotherapy was 12.5%.
CONCLUSION


Postoperative radiotherapy significantly increased disease-free survival and decreased local regional recurrence rate in patients with pathological T2-3N0M0 thoracic esophageal squamous cell carcinoma with acceptable toxicities in this interim analysis. Further enrollment and follow-up are warranted to validate these findings in this ongoing trial.
IMPLICATIONS FOR PRACTICE


The value of adjuvant radiotherapy for patients with node-negative esophageal cancer is not clear. The interim results of this phase III study indicated that postoperative radiotherapy significantly improved disease-free survival and decreased local-regional recurrence rate in patients with pathological T2-3N0M0 thoracic esophageal squamous cell carcinoma compared with surgery alone with acceptable toxicities. The distant metastasis rates and overall survival rates were not different between the two groups. Adjuvant radiotherapy should be considered for pathologic T2-3N0M0 thoracic esophageal squamous cell carcinoma. Prospective trials to identify high-risk subgroups are needed.",2020,Postoperative radiotherapy significantly increased disease-free survival and decreased local regional recurrence rate in patients with pathological T2,"['157 patients whose follow-up time was more than 1 year or who had died', 'Pathological T2-3N0M0 Thoracic Esophageal Squamous Cell Carcinoma', 'pathological T2-3N0M0 esophageal squamous cell carcinoma', 'patients with node-negative esophageal cancer', '3N0M0 thoracic esophageal squamous cell carcinoma', 'From October 2012 to February 2018, 167 patients were enrolled in this study', 'pathologic T2-3N0M0 thoracic esophageal squamous cell carcinoma', 'Patients aged 18-72\u2009years with pathological stage T2-3N0M0 esophageal squamous cell carcinoma after radical surgery and without neoadjuvant therapy were eligible', 'patients with pathological T2']","['adjuvant radiotherapy', 'surgery alone or to receive postoperative radiotherapy of 50.4 Gy in supraclavicular field and 56 Gy in mediastinal field in 28 fractions over 6\u2009weeks', 'Postoperative Radiotherapy', 'Adjuvant radiotherapy', 'postoperative radiotherapy', 'Postoperative radiotherapy', 'radiotherapy']","['overall survival and distant metastasis rates', 'efficacy and safety', 'distant metastasis rates and overall survival rates', 'local-regional recurrence rate', 'Local-regional recurrence rate', 'disease-free survival', 'Grade 3 toxicity rate', 'local-regional recurrence rate, overall survival, and radiation-related toxicities', 'local regional recurrence rate', '3-year disease-free survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0279626', 'cui_str': 'Esophageal Squamous Cell Carcinoma'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}]","[{'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach (qualifier value)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0025066', 'cui_str': 'Mediastinum'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",167.0,0.144201,Postoperative radiotherapy significantly increased disease-free survival and decreased local regional recurrence rate in patients with pathological T2,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Ni', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Chang', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Zongmei', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Dongfu', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Qinfu', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Jima', 'Initials': 'J', 'LastName': 'Lv', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Xiaozhen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Wenqing', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Bi', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Yexiong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Shugeng', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': ""Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': ""Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Yousheng', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': ""Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Kelin', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': ""Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Dekang', 'Initials': 'D', 'LastName': 'Fang', 'Affiliation': ""Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Dali', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Shao', 'Affiliation': ""Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Zhishan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Xinjie', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Han', 'Affiliation': ""Department of Oncology, Affiliated Hospital of Jining Medical College, Jining, Shandong, People's Republic of China.""}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Oncology, Affiliated Hospital of Jining Medical College, Jining, Shandong, People's Republic of China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Zefen', 'Initials': 'Z', 'LastName': 'Xiao', 'Affiliation': ""Department of Radiation Oncology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.""}]",The oncologist,['10.1634/theoncologist.2019-0276']
174,32183810,Intervention protocol: OPtimising thERapy to prevent avoidable hospital Admission in the Multi-morbid elderly (OPERAM): a structured medication review with support of a computerised decision support system.,"BACKGROUND


Several approaches to medication optimisation by identifying drug-related problems in older people have been described. Although some interventions have shown reductions in drug-related problems (DRPs), evidence supporting the effectiveness of medication reviews on clinical and economic outcomes is lacking. Application of the STOPP/START (version 2) explicit screening tool for inappropriate prescribing has decreased inappropriate prescribing and significantly reduced adverse drug reactions (ADRs) and associated healthcare costs in older patients with multi-morbidity and polypharmacy. Therefore, application of STOPP/START criteria during a medication review is likely to be beneficial. Incorporation of explicit screening tools into clinical decision support systems (CDSS) has gained traction as a means to improve both quality and efficiency in the rather time-consuming medication review process. Although CDSS can generate more potential inappropriate medication recommendations, some of these have been shown to be less clinically relevant, resulting in alert fatigue. Moreover, explicit tools such as STOPP/START do not cover all relevant DRPs on an individual patient level. The OPERAM study aims to assess the impact of a structured drug review on the quality of pharmacotherapy in older people with multi-morbidity and polypharmacy. The aim of this paper is to describe the structured, multi-component intervention of the OPERAM trial and compare it with the approach in the comparator arm.
METHOD


This paper describes a multi-component intervention, integrating interventions that have demonstrated effectiveness in defining DRPs. The intervention involves a structured history-taking of medication (SHiM), a medication review according to the systemic tool to reduce inappropriate prescribing (STRIP) method, assisted by a clinical decision support system (STRIP Assistant, STRIPA) with integrated STOPP/START criteria (version 2), followed by shared decision-making with both patient and attending physician. The developed method integrates patient input, patient data, involvement from other healthcare professionals and CDSS-assistance into one structured intervention.
DISCUSSION


The clinical and economical effectiveness of this experimental intervention will be evaluated in a cohort of hospitalised, older patients with multi-morbidity and polypharmacy in the multicentre, randomized controlled OPERAM trial (OPtimising thERapy to prevent Avoidable hospital admissions in the Multi-morbid elderly), which will be completed in the last quarter of 2019.
TRIAL REGISTRATION


Universal Trial Number: U1111-1181-9400 Clinicaltrials.gov: NCT02986425, Registered 08 December 2016. FOPH (Swiss national portal): SNCTP000002183. Netherlands Trial Register: NTR6012 (07-10-2016).",2020,Application of the STOPP/START (version 2) explicit screening tool for inappropriate prescribing has decreased inappropriate prescribing and significantly reduced adverse drug reactions (ADRs) and associated healthcare costs in older patients with multi-morbidity and polypharmacy.,"['older people with multi-morbidity and polypharmacy', 'older patients with multi-morbidity and polypharmacy in the multicentre', 'Universal Trial Number: U1111-1181-9400', 'FOPH (Swiss national portal', 'older patients with multi-morbidity and polypharmacy', 'Multi-morbid elderly (OPERAM', 'older people']","['CDSS', 'STOPP/START', 'structured history-taking of medication (SHiM), a medication review according to the systemic tool to reduce inappropriate prescribing (STRIP) method, assisted by a clinical decision support system (STRIP Assistant, STRIPA) with integrated STOPP/START criteria (version 2), followed by shared decision-making with both patient and attending physician']",['healthcare costs'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C2922974', 'cui_str': 'Polymedication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4042846', 'cui_str': 'STOPP START Criteria'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C2936303', 'cui_str': 'Inappropriate Prescribings'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0525070', 'cui_str': 'Decision Support Systems, Clinical'}, {'cui': 'C1321564', 'cui_str': 'Strip'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1320929', 'cui_str': 'Attending physician'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}]",,0.0784184,Application of the STOPP/START (version 2) explicit screening tool for inappropriate prescribing has decreased inappropriate prescribing and significantly reduced adverse drug reactions (ADRs) and associated healthcare costs in older patients with multi-morbidity and polypharmacy.,"[{'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Crowley', 'Affiliation': 'Pharmaceutical Care Research Group. School of Pharmacy, Cavanagh Pharmacy Building, University College Cork, Cork, Ireland.'}, {'ForeName': 'Bastiaan T G M', 'Initials': 'BTGM', 'LastName': 'Sallevelt', 'Affiliation': 'Department of Clinical Pharmacy, Division Laboratory and Pharmacy, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Corlina J A', 'Initials': 'CJA', 'LastName': 'Huibers', 'Affiliation': 'Department of Geriatric Medicine and Expertise Centre Pharmacotherapy in Old Persons, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Kevin D', 'Initials': 'KD', 'LastName': 'Murphy', 'Affiliation': 'Pharmaceutical Care Research Group. School of Pharmacy, Cavanagh Pharmacy Building, University College Cork, Cork, Ireland. kevin.murphy@ucc.ie.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Spruit', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Princetonplein 5, 3584CC, Utrecht, The Netherlands.'}, {'ForeName': 'Zhengru', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Department of Information and Computing Sciences, Utrecht University, Princetonplein 5, 3584CC, Utrecht, The Netherlands.'}, {'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Boland', 'Affiliation': 'Department of Geriatric Medicine, Cliniques universitaires Saint-Luc, Université catholique de Louvain UCLouvain, Brussels, Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Spinewine', 'Affiliation': 'Clinical Pharmacy Research Group, Louvain Drug Research Institute, Université catholique de Louvain UCLouvain, Brussels, Belgium.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Dalleur', 'Affiliation': 'Clinical Pharmacy Research Group, Louvain Drug Research Institute, Université catholique de Louvain UCLouvain, Brussels, Belgium.'}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Moutzouri', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Löwe', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Feller', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Schwab', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Luise', 'Initials': 'L', 'LastName': 'Adam', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Wilting', 'Affiliation': 'Department of Clinical Pharmacy, Division Laboratory and Pharmacy, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'Knol', 'Affiliation': 'Department of Geriatric Medicine and Expertise Centre Pharmacotherapy in Old Persons, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'Pharmaceutical Care Research Group. School of Pharmacy, Cavanagh Pharmacy Building, University College Cork, Cork, Ireland.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': ""O'Mahony"", 'Affiliation': 'Department of Medicine, University College Cork, Cork, Ireland.'}]",BMC health services research,['10.1186/s12913-020-5056-3']
175,30997482,Sex-Related Differences in Brain Volumes and Cerebral Blood Flow Among Overweight and Obese Adults With Type 2 Diabetes: Exploratory Analyses From the Action for Health in Diabetes Brain Magnetic Resonance Imaging Study.,"BACKGROUND


Sex may be an important modifier of brain health in response to risk factors. We compared brain structure and function of older overweight and obese women and men with type 2 diabetes mellitus.
METHODS


Cross-sectional cognitive assessments and magnetic resonance images were obtained in 224 women and 95 men (mean age 69 years) with histories of type 2 diabetes mellitus and overweight or obesity. Prior to magnetic resonance images, participants had completed an average of 10 years of random assignment to either multidomain intervention targeting weight loss or a control condition of diabetes support and education. Total (summed gray and white) matter volumes, white matter hyperintensity volumes, and cerebral blood flow across five brain regions of interest were analyzed using mixed-effects models.
RESULTS


After covariate adjustment, women, compared with men, averaged 10.9 [95% confidence interval 3.3, 18.5; ≈1%] cc greater summed region of interest volumes and 1.39 [0.00002, 2.78; ≈54%] cc greater summed white matter hyperintensity volumes. Sex differences could not be attributed to risk factor profiles or intervention response. Their magnitude did not vary significantly with respect to age, body mass index, intervention assignment, or APOE-ε4 genotype. Sex differences in brain magnetic resonance images outcomes did not account for the better levels of cognitive functioning in women than men.
CONCLUSIONS


In a large cohort of older overweight or obese adults with type 2 diabetes mellitus, differences in brain volumes and white matter disease were apparent between women and men, but these did not account for a lower prevalence of cognitive impairment in women compared with men in this cohort.
TRIAL REGISTRATION


NCT00017953.",2020,"Their magnitude did not vary significantly with respect to age, body mass index, intervention assignment, or APOE-ε4 genotype.","['participants had completed an average of 10 years of random assignment to either multidomain intervention targeting weight loss or a control condition of diabetes support and education', 'older overweight and obese women and men with type 2 diabetes mellitus', 'women than men', '224 women and 95 men (mean age 69 years) with histories of type 2 diabetes mellitus and overweight or obesity', 'Overweight and Obese Adults With Type 2 Diabetes', 'older overweight or obese adults with type 2 diabetes mellitus']",[],"['Brain Volumes and Cerebral Blood Flow', 'cognitive functioning', 'brain volumes and white matter disease', 'Total (summed gray and white) matter volumes, white matter hyperintensity volumes, and cerebral blood flow across five brain regions of interest']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C1272247', 'cui_str': 'Target weight'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0270612', 'cui_str': 'White Matter Diseases'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1269776', 'cui_str': 'Gray'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0682708'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}]",224.0,0.0891676,"Their magnitude did not vary significantly with respect to age, body mass index, intervention assignment, or APOE-ε4 genotype.","[{'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Winston-Salem, NC.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Hayden', 'Affiliation': 'Department of Social Sciences and Health Policy, Winston-Salem, NC.'}, {'ForeName': 'Samuel N', 'Initials': 'SN', 'LastName': 'Lockhart', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Hussein N', 'Initials': 'HN', 'LastName': 'Yassine', 'Affiliation': 'Department of Medicine, Keck School of Medicine, University of Southern California. Los Angeles, CA.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Hoscheidt', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Sevil', 'Initials': 'S', 'LastName': 'Yasar', 'Affiliation': 'Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Luchsinger', 'Affiliation': 'Department of Medicine, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Biostatistics and Data Science, Winston-Salem, NC.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Diaz Brinton', 'Affiliation': 'University of Arizona Center for Innovation in Brain Science, The University of Arizona Health Sciences, Tucson, AZ.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Carmichael', 'Affiliation': 'Biomedical Imaging Center, Pennington Biomedical Research Center, Baton Rouge, LA.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz090']
176,31183985,"Effect of Food on the Pharmacokinetics of 2 Formulations of DRL-17822, a Novel Selective Cholesteryl Ester Transfer Protein (CETP) Inhibitor, in Healthy Males.","DRL-17822 is a novel selective cholesteryl ester transfer protein inhibitor that showed an increased exposure, including an increase of >20-fold of maximum concentration and area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration, following a high-fat breakfast using a nanocrystal formulation. To reduce this effect of food, we generated an amorphous solid dispersion formulation. In this study, we compared the food effect of both formulations of DRL-17822 in a 2-part randomized, open-label, 4-way crossover study involving healthy adult males 18-45 years of age. In both parts of the study, 12 subjects received both formulations of DRL-17822 in both the fasted and fed states; a low-fat breakfast was provided in the first part and a high-fat breakfast in the second part. Compared to the nanocrystal formulation, the amorphous solid dispersion formulation substantially increased DRL-17822 exposure in the fasted state, including increased maximum concentration, area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration, and area under plasma concentration-time curve from time zero to infinity. Following a high-fat breakfast, DRL-17822 exposure was increased to a lesser extent in the amorphous solid dispersion formulation compared to the nanocrystal formulation (P < .001). Moreover, compared to the nanocrystal formulation the amorphous solid dispersion formulation caused a more pronounced increase in high-density lipoprotein in the fasted state. Consuming breakfast increased the effect of DRL-17822 on high-density lipoprotein. Taken together, our results indicate that by improving its formulation, DRL-17822 has a favorable exposure profile and therefore a more predictable food effect profile.",2019,"Following a high-fat breakfast, DRL-17822 exposure was increased to a lesser extent in the amorphous solid dispersion formulation compared to the nanocrystal formulation (P < .001).","['Healthy Males', 'healthy adult males 18-45 years of age']","['DRL-17822, a Novel Selective Cholesteryl Ester Transfer', 'Protein (CETP) Inhibitor', 'DRL-17822']","['high-density lipoprotein', 'maximum concentration, area under the plasma concentration-time curve']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0008387', 'cui_str': 'Cholesteryl Esters'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.0166251,"Following a high-fat breakfast, DRL-17822 exposure was increased to a lesser extent in the amorphous solid dispersion formulation compared to the nanocrystal formulation (P < .001).","[{'ForeName': 'Annelieke C', 'Initials': 'AC', 'LastName': 'Kruithof', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Rajinder', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': ""Dr. Reddy's Laboratories Ltd, Hyderabad, India.""}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Marieke L', 'Initials': 'ML', 'LastName': 'de Kam', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Anirudh', 'Initials': 'A', 'LastName': 'Gautam', 'Affiliation': ""Dr. Reddy's Laboratories SA, Basel, Switzerland.""}, {'ForeName': 'Shanavas', 'Initials': 'S', 'LastName': 'Alikunju', 'Affiliation': ""Dr. Reddy's Laboratories Ltd, Hyderabad, India.""}, {'ForeName': 'Bijay K', 'Initials': 'BK', 'LastName': 'Padhi', 'Affiliation': ""Dr. Reddy's Laboratories Ltd, Hyderabad, India.""}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Kulkarni', 'Affiliation': ""Dr. Reddy's Laboratories Ltd, Hyderabad, India.""}, {'ForeName': 'Rajeev S', 'Initials': 'RS', 'LastName': 'Raghuvanshi', 'Affiliation': ""Dr. Reddy's Laboratories Ltd, Hyderabad, India.""}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Gandhi', 'Affiliation': ""Dr. Reddy's Laboratories Ltd, Hyderabad, India.""}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Ingrid M C', 'Initials': 'IMC', 'LastName': 'Kamerling', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.707']
177,32317100,Outcomes of Patients With Coronary Arterial Bifurcation Narrowings Undergoing Provisional 1-Stent Treatment (from the BIONICS Trial).,"Treatment of bifurcation lesions is technically challenging and has been associated with an increased risk of adverse events. We sought to evaluate the clinical and angiographic outcomes of patients who underwent bifurcation lesion provisional treatment in the BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis trial. A prospective, multicenter, 1:1 randomized trial was conducted to evaluate the safety and efficacy of ridaforolimus-eluting stents (RES) versus zotarolimus-eluting stents (ZES). Enrollment of bifurcation lesions treated with a provisional 1-stent technique was allowed. Bifurcation lesions were analyzed by an angiographic core laboratory. Outcomes were analyzed according to the presence of a bifurcation lesion treatment. Study population included 686 (35.8%) patients with and 1,228 (64.2%) patients without bifurcation lesion treatment. Procedural success was high and similar between groups. In 2 years, there was no difference in the rate of target lesion failure between the bifurcation and nonbifurcation groups (7.6% vs 7.3%, respectively, p = 0.81) regardless of the presence of side branch stenosis ≥50%. In 159 patients with angiographic follow-up, there was no difference in the rate of binary restenosis between groups (9.0% vs 9.2%, p = 0.96). Rates of target lesion failure at 1-year were similar with ZES and RES, and consistent in patients with and without bifurcation lesions (p interaction  = 0.61). In conclusion, patients with bifurcation lesions treated and a provisional strategy experienced similar outcomes as those with nonbifurcation lesions. RES performed as well as ZES in bifurcation and nonbifurcation lesions.",2020,"In 2 years, there was no difference in the rate of target lesion failure between the bifurcation and nonbifurcation groups (7.6% vs 7.3%, respectively, p = 0.81) regardless of the presence of side branch stenosis ≥50%.","['Patients With Coronary Arterial Bifurcation Narrowings Undergoing Provisional 1-Stent Treatment (from the BIONICS Trial', 'patients who underwent bifurcation lesion provisional treatment in the BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis trial', '159 patients with angiographic follow-up', 'Study population included 686 (35.8%) patients with and 1,228 (64.2%) patients without bifurcation lesion treatment']",['ridaforolimus-eluting stents (RES) versus zotarolimus-eluting stents (ZES'],"['rate of target lesion failure', 'Rates of target lesion failure', 'safety and efficacy', 'rate of binary restenosis', 'Procedural success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005549', 'cui_str': 'Bionics'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C2713007', 'cui_str': 'ridaforolimus'}, {'cui': 'C0687568', 'cui_str': 'Coronary artery stent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0242231', 'cui_str': 'Coronary artery stenosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5191070', 'cui_str': '686'}]","[{'cui': 'C2713007', 'cui_str': 'ridaforolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1700035', 'cui_str': 'Zotarolimus'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}]",159.0,0.065132,"In 2 years, there was no difference in the rate of target lesion failure between the bifurcation and nonbifurcation groups (7.6% vs 7.3%, respectively, p = 0.81) regardless of the presence of side branch stenosis ≥50%.","[{'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Konigstein', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Tel-Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv, Israel.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, Georgia.'}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Love', 'Affiliation': 'University of Manitoba, St. Boniface General Hospital, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Banai', 'Affiliation': 'Tel-Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv, Israel.'}, {'ForeName': 'Mordechai', 'Initials': 'M', 'LastName': 'Golomb', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Gidon Y', 'Initials': 'GY', 'LastName': 'Perlman', 'Affiliation': 'Hadassah Hebrew University Medical Center, Jerusalem, Israel; Medinol Ltd., Tel Aviv, Israel.'}, {'ForeName': 'Melek Ozgu', 'Initials': 'MO', 'LastName': 'Ozan', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Mengdan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: gstone@crf.org.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.04.002']
178,32311349,Pneumonia and Exposure to Household Air Pollution in Children Under the Age of 5 Years in Rural Malawi: Findings From the Cooking and Pneumonia Study.,"BACKGROUND


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


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


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


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


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


ISRCTN59448623.",2020,"The group difference in means was 0.46 (95% CI:-0.95-0.012; p=0.06).
","['children under the age of 5 years in rural Malawi', 'children under the age of 5 years in rural Malawi - the Cooking And Pneumonia Study (CAPS', 'children participating in a cluster-randomised controlled trial of a', 'young children instead', 'We recruited 1805 (928 intervention; 877 control) children (mean age 25.6 months, 50.6% female', 'children under the age of 5 in rural Malawi']","['COHb ', 'CAPS intervention', 'personal exposure to carbon monoxide (CO', 'transcutaneous carboxyhemoglobin (COHb', 'cleaner-burning biomass-fueled cookstove intervention']",['Median exposure to CO'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0007061', 'cui_str': 'Carboxyhemoglobin'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0238889', 'cui_str': 'Exposure to carbon monoxide'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0005535', 'cui_str': 'Biomass'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0238889', 'cui_str': 'Exposure to carbon monoxide'}]",,0.0927706,"The group difference in means was 0.46 (95% CI:-0.95-0.012; p=0.06).
","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Mortimer', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK. Electronic address: Kevin.mortimer@lstmed.ac.uk.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Lesosky', 'Affiliation': 'University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Semple', 'Affiliation': 'Stirling University, Stirling, UK.'}, {'ForeName': 'Jullita', 'Initials': 'J', 'LastName': 'Malava', 'Affiliation': 'Malawi Epidemiology and Intervention Research Unit, Chilumba, Malawi.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Katundu', 'Affiliation': 'Malawi Epidemiology and Intervention Research Unit, Chilumba, Malawi.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Crampin', 'Affiliation': 'Malawi Epidemiology and Intervention Research Unit, Chilumba, Malawi; London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Weston', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Pope', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Havens', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Gordon', 'Affiliation': 'Liverpool School of Tropical Medicine, Liverpool, UK; Malawi Liverpool Wellcome Trust Programme, Blantyre, Malawi.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Balmes', 'Affiliation': 'University of California, Berkeley, CA; University of California, San Francisco, San Francisco, CA.'}]",Chest,['10.1016/j.chest.2020.03.064']
179,32312590,Minimally invasive surgery in elderly patients with rectal cancer: An analysis of the Bi-National Colorectal Cancer Audit (BCCA).,"BACKGROUND


Advanced age is associated with worse outcomes after open rectal cancer surgery. However, not much is known about outcomes of minimally invasive surgery (MIS) in the elderly. The aim of this study was to evaluate safety and efficacy of MIS in elderly rectal cancer patients using the Bi-national Colorectal Cancer Audit (BCCA) data from Australia and New Zealand (ANZ).
METHODS


3451 patients were included, divided into three groups: <50 years (n = 364), 50-74 years (n = 2157) and ≥75 years (n = 930). Propensity-score matching was performed for the elderly group analysis to correct for differences in baseline characteristics.
RESULTS


MIS was performed in 52.9% of elderly patients, slightly lower than rates in <50 year and 50-74 year old groups (61% and 55.5%, respectively, p = 0.022). Elderly patients had more postoperative complications (p < 0.0001) and had a longer length of hospital stay (LOS; median 11 vs. 8 days for both other groups; p < 0.0001). Elderly patients had higher (y)pT-stages compared to both other groups (p < 0.0001) and were less likely to receive adjuvant therapy (p < 0.0001). Propensity-score matched analysis of the elderly group showed a higher rate of superficial wound dehiscence and a longer LOS after open surgery compared to MIS (10.3% vs. 2.6%, p = 0.030; 12 days vs. 9.5 days, p = 0.001, respectively), with comparable short-term oncological outcomes.
CONCLUSIONS


MIS is performed in just over half of elderly rectal cancer patients who are selected for elective rectal resection surgery in ANZ. When performed in the elderly, MIS appears safe and is associated with fewer wound complications and a shorter LOS.",2020,Elderly patients had higher (y)pT-stages compared to both other groups (p < 0.0001) and were less likely to receive adjuvant therapy (p < 0.0001).,"['elderly rectal cancer patients using the Bi-national Colorectal Cancer Audit (BCCA) data from Australia and New Zealand (ANZ', 'elderly rectal cancer patients who are selected for elective rectal resection surgery in ANZ', '3451 patients were included, divided into three groups: <50 years (n\xa0=\xa0364), 50-74 years (n\xa0=\xa02157) and ≥75 years (n\xa0=\xa0930', 'elderly patients with rectal cancer']","['Minimally invasive surgery', 'minimally invasive surgery (MIS', 'MIS']","['postoperative complications', 'safety and efficacy', 'rate of superficial wound dehiscence and a longer LOS', 'longer length of hospital stay']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0193062', 'cui_str': 'Resection of rectum'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332804', 'cui_str': 'Superficial wound'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",3451.0,0.0936043,Elderly patients had higher (y)pT-stages compared to both other groups (p < 0.0001) and were less likely to receive adjuvant therapy (p < 0.0001).,"[{'ForeName': 'Meike J', 'Initials': 'MJ', 'LastName': 'van Harten', 'Affiliation': 'Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Emma B', 'Initials': 'EB', 'LastName': 'Greenwood', 'Affiliation': 'Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Sergei', 'Initials': 'S', 'LastName': 'Bedrikovetski', 'Affiliation': 'Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia; Faculty of Health and Medical Science, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Nagendra N', 'Initials': 'NN', 'LastName': 'Dudi-Venkata', 'Affiliation': 'Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia; Faculty of Health and Medical Science, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Ronald A', 'Initials': 'RA', 'LastName': 'Hunter', 'Affiliation': 'Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Hidde M', 'Initials': 'HM', 'LastName': 'Kroon', 'Affiliation': 'Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia; Faculty of Health and Medical Science, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia. Electronic address: Hidde.Kroon@SA.GOV.AU.'}, {'ForeName': 'Tarik', 'Initials': 'T', 'LastName': 'Sammour', 'Affiliation': 'Colorectal Unit, Department of Surgery, Royal Adelaide Hospital, Adelaide, South Australia, Australia; Faculty of Health and Medical Science, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2020.03.224']
180,32077550,The Impact of Anlotinib on Brain Metastases of Non-Small Cell Lung Cancer: Post Hoc Analysis of a Phase III Randomized Control Trial (ALTER0303).,"BACKGROUND


Anlotinib has been shown to prolong progression-free survival (PFS) and overall survival (OS) for non-small cell lung cancer (NSCLC). Herein we sought to analyze the effect of anlotinib in managing brain metastases (BM) and its brain-associated toxicities.
METHODS


The PFS and OS of anlotinib versus placebo in those with and without BM recorded at baseline were calculated and compared respectively. Time to brain progression (TTBP), a direct indicator of intracranial control, was also compared between anlotinib and placebo. All calculations were adjusted for confounding factors, including stage, histology, driver mutation type, and therapy history.
RESULTS


A total of 437 patients were included; 97 cases were recorded with BM at baseline. For patients with BM at baseline, anlotinib was associated with longer PFS (hazard ratio [HR], 0.29; 95% confidence interval [CI], 0.15-0.56) and OS (HR, 0.72; 95% CI, 0.42-1.12), presenting similar extent of improvement in those without BM (PFS: HR, 0.33; 95% CI, 0.24-0.45; OS: HR, 0.67; 95% CI, 0.50-0.91). Specifically, the intracranial objective response rate was 14.3% and the disease control rate was 85.7% in patients with BM who were treated with anlotinib. Anlotinib was associated with longer TTBP (HR, 0.11; 95% CI, 0.03-0.41; p = .001) despite all confounders. Additionally, anlotinib was associated with more neural toxicities (18.4% vs. 8.4%) and psychological symptoms (49.3% vs. 35.7%) but not with infarction or cerebral hemorrhage.
CONCLUSION


Anlotinib can benefit patients with advanced NSCLC with BM and is highly potent in the management of intracranial lesions. Its special effect on BM and cerebral tissue merits further investigation. (ClinicalTrials.gov ID: NCT02388919).",2020,"Anlotinib was associated with longer TTBP (HR, 0.11; 95% CI, 0.03-0.41; p = .001) despite all confounders.",['A total of 437 patients were included; 97 cases were recorded with BM at baseline'],['placebo'],"['neural toxicities', 'progression-free survival (PFS) and overall survival (OS', 'intracranial objective response rate', 'psychological symptoms', 'disease control rate', 'Time to brain progression (TTBP']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",437.0,0.467281,"Anlotinib was associated with longer TTBP (HR, 0.11; 95% CI, 0.03-0.41; p = .001) despite all confounders.","[{'ForeName': 'Shunjun', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Hengrui', 'Initials': 'H', 'LastName': 'Liang', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhichao', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""Department of General Internal Medicine, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Zhanhong', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yalei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Baohui', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': ""Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai, People's Republic of China.""}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': ""Department\u2009of Thoracic Surgery and Oncology, the First Affiliated Hospital of Guangzhou Medical University, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, Guangzhou, People's Republic of China.""}]",The oncologist,['10.1634/theoncologist.2019-0838']
181,32321389,Evaluation of Proactive Community Case Detection to Increase Help Seeking for Mental Health Care: A Pragmatic Randomized Controlled Trial.,"OBJECTIVE


The Community Informant Detection Tool (CIDT) is a vignette- and picture-based method of proactive case detection to promote help seeking for persons with depression, psychosis, alcohol use disorder, and epilepsy. The authors evaluated the effectiveness of the CIDT to increase help-seeking behavior in rural Nepal, where a district mental health care plan was being implemented.
METHODS


Twenty-four health facilities were randomly assigned to one of two methods for training their all-female cadre of community health volunteers: standard training or standard training that included the CIDT. The authors compared the number of patients with depression, psychosis, alcohol use disorder, and epilepsy who were registered in the routine health information system prior to and 6 months after the training.
RESULTS


At health facilities where volunteers received CIDT training, 309 patients were registered as having depression, psychosis, alcohol use disorder, or epilepsy, compared with 182 patients at facilities where volunteers received standard training. The median number of patients registered was 47% greater at facilities where CIDT training was included (24 patients) than at facilities with standard training (16 patients) (p=0.04, r=0.42). The difference in the number of registered patients remained significant when the analysis factored in the population catchment (N=18 patients [CIDT] versus N=14 [standard] per 10,000 population; p=0.05, r=0.40).
CONCLUSIONS


The median number of patients registered as having a mental illness was 47% greater at primary care facilities in which community health volunteers used the CIDT than at facilities where volunteers received standard training. Proactive case finding holds promise for increasing help seeking for mental health care.",2020,The median number of patients registered as having a mental illness was 47% greater at primary care facilities in which community health volunteers used the CIDT than at facilities where volunteers received standard training.,"['309 patients were registered as having depression, psychosis, alcohol use disorder, or epilepsy, compared with 182 patients at facilities where volunteers received', 'Twenty-four health facilities', 'Mental Health Care', 'patients with depression, psychosis, alcohol use disorder, and epilepsy who were registered in the routine health information system prior to and 6 months after the training']","['CIDT training', 'training their all-female cadre of community health volunteers: standard training or standard training that included the CIDT', 'standard training', 'CIDT', 'Proactive Community Case Detection', 'Community Informant Detection Tool (CIDT']","['median number of patients registered', 'median number of patients registered as having a mental illness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0679918', 'cui_str': 'Health Information Systems'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0585825', 'cui_str': 'Patient registered'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]",309.0,0.0371716,The median number of patients registered as having a mental illness was 47% greater at primary care facilities in which community health volunteers used the CIDT than at facilities where volunteers received standard training.,"[{'ForeName': 'Mark J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London (Jordans, Lund); Transcultural Psychosocial Organization (TPO) Nepal, Kathmandu (Jordans, Luitel, Kohrt); Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa (Lund); Department of Psychiatry, George Washington University, Washington, D.C. (Kohrt).""}, {'ForeName': 'Nagendra P', 'Initials': 'NP', 'LastName': 'Luitel', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London (Jordans, Lund); Transcultural Psychosocial Organization (TPO) Nepal, Kathmandu (Jordans, Luitel, Kohrt); Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa (Lund); Department of Psychiatry, George Washington University, Washington, D.C. (Kohrt).""}, {'ForeName': 'Crick', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London (Jordans, Lund); Transcultural Psychosocial Organization (TPO) Nepal, Kathmandu (Jordans, Luitel, Kohrt); Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa (Lund); Department of Psychiatry, George Washington University, Washington, D.C. (Kohrt).""}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Kohrt', 'Affiliation': ""Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London (Jordans, Lund); Transcultural Psychosocial Organization (TPO) Nepal, Kathmandu (Jordans, Luitel, Kohrt); Alan J. Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa (Lund); Department of Psychiatry, George Washington University, Washington, D.C. (Kohrt).""}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201900377']
182,30950565,"First-in-Human Pharmacokinetics and Safety Study of GSK3008356, a Selective DGAT1 Inhibitor, in Healthy Volunteers.","Diacylglycerol acyltransferase (DGAT) enzymes are involved in triglyceride (TG) biosynthesis. GSK3008356 is a potent and selective DGAT1 inhibitor that was administered orally in a 2-part study as double-blind, randomized, placebo-controlled single doses (SDs) and repeat doses (RDs) in healthy subjects to investigate its pharmacokinetics, pharmacodynamics, and safety/tolerability. Gastrointestinal adverse events were considered drug related and increased with dose and when given as multiple doses. In the SD part (n = 80), GSK3008356 was dosed from 5 to 200 mg as single or multiple doses per day. In the RD part (n = 24), GSK3008356 was dosed twice daily at 1, 3, and 10 mg for 14 days. GSK3008356 was generally well tolerated in the SD and RD parts. With single doses, absorption was rapid (median t max  , 0.5-1.5 hours), whereas single-day divided dosing resulted in higher t max  . Following 14-day RD oral administration, GSK3008356 was also rapidly absorbed, with median t max  ranging from 0.5 to 0.75 hours on days 1 and 14. Estimated mean half-life ranged from 1.5 to 4.6 hours with SDs and 1.3 to 2.1 hours with RDs. Exposure of GSK3008356 was largely dose proportional after RDs. At higher doses, there was a trend toward lower absolute postprandial TG level in some subjects.",2019,"With single doses, absorption was rapid (median t max  , 0.5-1.5 hours), whereas single-day divided dosing resulted in higher t max  .","['Healthy Volunteers', 'healthy subjects']",['placebo'],"['pharmacokinetics, pharmacodynamics, and safety/tolerability', 'Gastrointestinal adverse events', 'absolute postprandial TG level', 'tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0342514,"With single doses, absorption was rapid (median t max  , 0.5-1.5 hours), whereas single-day divided dosing resulted in higher t max  .","[{'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Okour', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Gress', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Xinyi', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rieman', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network, Melbourne, Victoria, Australia.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Brigandi', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.691']
183,32315362,Variability in engagement and progress in efficacious integrated collaborative care for primary care patients with obesity and depression: Within-treatment analysis in the RAINBOW trial.,"INTRODUCTION


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


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


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


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


ClinicalTrials.gov# NCT02246413.",2020,"Objectively measured weight loss and depression outcomes were significantly worse among participants with poor engagement or poor progress on either weight or PHQ-9 than those showing progress on both.
","['primary care patients with obesity and depression', '204 intervention participants (50.9 [SD, 12.2] years, 71% female, 72% non-Hispanic White, BMI 36.7 [6.9], PHQ-9 14.1 [3.2]), 31% (n = 63) had poor engagement, on average completing self-monitored weight in <3 of 46 weeks and <5 of 15 sessions', 'Engaged participants (n = 141; 69', 'Data were collected in 2014-2017 and analyzed post hoc in 2018']",['integrated collaborative care intervention'],"['milder depression', 'weight loss and depression outcomes', 'weight change', 'moderate weight loss', 'self-monitored weight', 'substantial weight loss', 'moderate depression', 'self-monitored weight and PHQ-9 scores', 'minimal weight loss']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}]",,0.0287906,"Objectively measured weight loss and depression outcomes were significantly worse among participants with poor engagement or poor progress on either weight or PHQ-9 than those showing progress on both.
","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois, United States of America.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, California, United States of America.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Majd', 'Affiliation': 'Department of Biobehavioral Health, Pennsylvania State University, University Park, Pennsylvania, United States of America.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Lavori', 'Affiliation': 'Department of Biomedical Data Science, Stanford University, Stanford, California, United States of America.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': 'Department of Biobehavioral Health, Pennsylvania State University, University Park, Pennsylvania, United States of America.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Health Research and Policy and Medicine, Stanford University, Palo Alto, California, United States of America.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States of America.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington, United States of America.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'Center for Communications Science, RTI International, Seattle, Washington, United States of America.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ward', 'Affiliation': 'Pacific Coast Psychiatric Associates, San Francisco, California, United States of America.'}, {'ForeName': 'Lenard', 'Initials': 'L', 'LastName': 'Lesser', 'Affiliation': 'One Medical, San Francisco, California, United States of America.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California, United States of America.'}, {'ForeName': 'Kristen M J', 'Initials': 'KMJ', 'LastName': 'Azar', 'Affiliation': 'Sutter Health Research Enterprise, Center for Health Systems Research, Walnut Creek, California, United States of America.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Institute of Health Research and Policy, University of Illinois at Chicago, Chicago, Illinois, United States of America.'}]",PloS one,['10.1371/journal.pone.0231743']
184,32317212,"Acceptability, safety, and feasibility of in-bed cycling with critically ill patients.","BACKGROUND


In-bed cycling is a promising intervention that may assist critically ill patients to maintain muscle mass and improve their trajectory of recovery. The acceptability of in-bed cycling from the different perspectives of patients, clinicians, and families are unknown. In addition, the safety and feasibility of in-bed cycling in an Australian tertiary intensive care unit (ICU) is relatively unknown.
OBJECTIVES


The objective of this study was to examine the acceptability, safety, and feasibility of in-bed cycling in an Australian tertiary, adult, mixed medical, surgical, trauma ICU.
METHODS


An observational process evaluation was embedded in one arm of a two-arm parallel phase II randomised controlled trial that was conducted in an Australian tertiary ICU. The process evaluation was of the acceptability, safety, and feasibility of passive and active in-bed cycling for participants allocated to the trial intervention group. In-bed cycling acceptability questionnaires were designed through a three-step Delphi process. Questionnaire responses from patients, family members, and clinicians who participated in or observed the intervention during the Critical Care Cycling Study (CYCLIST) were evaluated to determine the acceptability of in-bed cycling. The congruence of responses between respondents was also compared. Safety and feasibility of the in-bed cycling intervention were assessed against predetermined criteria.
RESULTS


Acceptability questionnaire responses demonstrated that in-bed cycling was an acceptable intervention from the perspectives of patients, family members, and clinicians. Questionnaire responses were congruent across the respondent groups. Safety was demonstrated with two minor transient adverse events occurring during 276 in-bed cycling sessions (adverse event rate: 0.7%). In-bed cycling sessions were feasible with 276 of 304 (90%) planned sessions conducted.
CONCLUSIONS


Acceptability questionnaire responses found that in-bed cycling was regarded as an acceptable intervention to patients, family members, and clinicians. The implementation of in-bed cycling was safe and feasible to complete with critically ill patients during the early stages of their critical illness in an Australian tertiary ICU setting.",2020,Safety was demonstrated with two minor transient adverse events occurring during 276 in-bed cycling sessions (adverse event rate: 0.7%).,"['critically ill patients', 'patients, family members, and clinicians who participated in\xa0or observed the intervention during the Critical Care Cycling Study (CYCLIST', 'critically ill patients during the early stages of their critical illness in an Australian tertiary ICU setting', 'Australian tertiary intensive care unit (ICU']",[],"['Acceptability, safety, and feasibility', 'Acceptability questionnaire responses', 'safety and feasibility', 'Questionnaire responses', 'acceptability, safety, and feasibility', 'acceptability, safety, and feasibility of passive and active']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",[],"[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205177', 'cui_str': 'Active'}]",,0.0553266,Safety was demonstrated with two minor transient adverse events occurring during 276 in-bed cycling sessions (adverse event rate: 0.7%).,"[{'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Nickels', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Australian Centre for Health Services Innovation and Centre for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia; Centre for Functioning and Health Research, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: marc.nickels@health.qld.gov.au.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Aitken', 'Affiliation': 'School of Health Sciences, City, University of London, London, United Kingdom; Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia. Electronic address: leanne.aitken.1@city.ac.uk.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Barnett', 'Affiliation': 'Australian Centre for Health Services Innovation and Centre for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia. Electronic address: a.barnett@qut.edu.au.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Walsham', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; School of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: james.walsham@health.qld.gov.au.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'Australian Centre for Health Services Innovation and Centre for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia; Centre for Functioning and Health Research, Metro South Health, Brisbane, Queensland, Australia; Clinical Informatics, Metro South Health, Brisbane, Australia. Electronic address: steven.mcphail@qut.edu.au.'}]",Australian critical care : official journal of the Confederation of Australian Critical Care Nurses,['10.1016/j.aucc.2020.02.007']
185,32243365,Effects of anodal transcranial direct current stimulation over the contralesional hemisphere on motor recovery in subacute stroke patients with severe upper extremity hemiparesis: Study protocol for a randomized controlled trial.,"INTRODUCTION


Upper extremity motor impairment is one of the major sequelae of stroke, resulting in limitations of activities of daily living. Recently, contralesional cortical activation has been reported to be important for motor recovery in stroke patients with severe upper extremity hemiparesis due to the extensive corticospinal tract involvement. We therefore designed this study to investigate the effects of contralesional anodal transcranial direct current stimulation (tDCS), which induces cortical activation, in stroke patients with severe upper extremity motor impairment.
METHODS AND ANALYSIS


We will recruit patients with subacute stroke (<3 months after onset) with unilateral upper extremity weakness who meet the following criteria: Shoulder Abduction and Finger Extension (SAFE) score below 8, Fugl-Meyer Assessment for upper extremity (FMA-UE) score ≤25, and absent motor evoked potential (MEP) response on the affected extensor carpi radialis muscle. Subjects will be randomly allocated to either the intervention (n = 18) or the control group (n = 18). The intervention group will undergo 10 sessions of robotic arm rehabilitation with simultaneous anodal tDCS over the contralesional premotor area, whereas the control group will receive sham tDCS during the same sessions. One daily session consists of 25 minutes.The primary outcome measure of this study is the Fugl-Meyer Assessment score of the upper extremity; the secondary outcome measures are the Korean version of the Modified Barthel Index, the Brunnstrom stage of the affected arm and hand, the Box and Block Test, the Modified Ashworth Scale, the Manual Muscle Power Test, and the patient's encephalographic laterality index.
DISCUSSION


Findings of this study will help to establish an individualized tDCS protocol according to the stroke severity and to find out the EEG parameters to predict the better recovery in subacute stroke patients with severe upper extremity hemiparesis.
ETHICS AND DISSEMINATION


The study was approved by the Seoul National University Bundang Hospital Institutional Review Board (IRB No. B-1806-475-006) and will be carried out in accordance with the approved guidelines. The results of the trial will be submitted for publication in a peer-reviewed journal.",2020,"Recently, contralesional cortical activation has been reported to be important for motor recovery in stroke patients with severe upper extremity hemiparesis due to the extensive corticospinal tract involvement.","['patients with subacute stroke (<3 months after onset) with unilateral upper extremity weakness who meet the following criteria: Shoulder Abduction and Finger Extension (SAFE) score below 8, Fugl-Meyer Assessment for upper extremity (FMA-UE) score ≤25, and absent motor evoked potential (MEP) response on the affected extensor carpi radialis muscle', 'stroke patients with severe upper extremity hemiparesis', 'subacute stroke patients with severe upper extremity hemiparesis', 'stroke patients with severe upper extremity motor impairment']","['contralesional anodal transcranial direct current stimulation (tDCS', 'anodal transcranial direct current stimulation', 'robotic arm rehabilitation with simultaneous anodal tDCS over the contralesional premotor area, whereas the control group will receive sham tDCS']","[""Fugl-Meyer Assessment score of the upper extremity; the secondary outcome measures are the Korean version of the Modified Barthel Index, the Brunnstrom stage of the affected arm and hand, the Box and Block Test, the Modified Ashworth Scale, the Manual Muscle Power Test, and the patient's encephalographic laterality index""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0224265', 'cui_str': 'Structure of extensor carpi radialis muscle'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0336542', 'cui_str': 'Robotic arm'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0228202', 'cui_str': 'Premotor cortex'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023114', 'cui_str': 'Handedness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0509946,"Recently, contralesional cortical activation has been reported to be important for motor recovery in stroke patients with severe upper extremity hemiparesis due to the extensive corticospinal tract involvement.","[{'ForeName': 'Stephanie Hyeyoung', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Won-Seok', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Junsik', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Nam-Jong', 'Initials': 'NJ', 'LastName': 'Paik', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000019495']
186,31611635,A pilot trial of pembrolizumab plus prostatic cryotherapy for men with newly diagnosed oligometastatic hormone-sensitive prostate cancer.,"BACKGROUND


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


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


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


Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab treatment was well tolerated and no safety concerns were observed in men with oligometastatic prostate cancer. Though local disease appeared effectively treated in the majority of men, the regimen only infrequency led to sustained disease control following testosterone recovery.",2020,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
","['12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016', 'men with oligometastatic hormone-sensitive prostate cancer', 'patients with evaluable tissue', 'men with newly diagnosed oligometastatic hormone-sensitive prostate cancer', 'men with advanced prostate cancer', 'men with oligometastatic prostate cancer']","['pembrolizumab plus prostatic cryotherapy', 'whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab', 'whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation', 'Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab']","['frequency of adverse events', 'Median progression-free survival', 'tolerated and no safety concerns', 'safety and feasibility', 'progression-free survival and systemic therapy-free survival', 'number of patients with a PSA level', 'median systemic therapy-free survival', 'PD-L1 protein expression', 'PD-L1 expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0843747', 'cui_str': 'Prostate cryoablation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.114774,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy.
","[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA. ashley.ross@usoncology.com.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Hurley', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'The Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Sciences, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Benzon', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': ""Tanya O'"", 'Initials': 'TO', 'LastName': 'Neal', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Chapman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Harb', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Milman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Trock', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'The Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0176-8']
187,32301973,Corneal Stroma Cell Density Evolution in Keratoconus Corneas Following the Implantation of Adipose Mesenchymal Stem Cells and Corneal Laminas: An In Vivo Confocal Microscopy Study.,"Purpose


To report the corneal stroma cell density evolution identified by in vivo corneal confocal microscopy in humans using injected autologous adipose-derived adult stem cells (ADASCs) and corneal decellularized laminas in corneas with advanced keratoconus.
Methods


Interventional prospective, consecutive, randomized, comparative series of cases. A total of 14 keratoconic patients were randomly distributed into three groups for three types of surgical interventions: group 1 (G-1), autologous ADASC implantation (n = 5); group 2 (G-2), decellularized human corneal stroma (n = 5); and group 3 (G-3), autologous ADASCs + decellularized human corneal stroma (n = 4).
Results


A gradual and significant increase (P < 0.001) was observed in the cellularity in the anterior and posterior stroma of patients in G-1, G-2, and G-3 a year after the surgery in comparison with the preoperative density level. The same result was observed at the mid-corneal stroma in G-1 and at the anterior and posterior surfaces and within the laminas in G-2 and G-3. The cell density of patients receiving ADASC recellularized laminas (G-3) was statistically significantly higher (P = 0.011) at the anterior surface and within the lamina (P = 0.029) and at the posterior surface than in those implanted only with decellularized laminas (G-2).
Conclusions


A significant increase in cell density occurred up to 1 postoperative year at the corneal stroma following the implantation of ADASCs alone, as well as in those cases implanted with decellularized and recellularized laminas at the different levels of the analysis. However, this increase was significantly higher in the ADASC recellularized laminas.",2020,"The cell density of patients receiving ADASC recellularized laminas (G-3) was statistically significantly higher (P = 0.011) at the anterior surface and within the lamina (P = 0.029) and at the posterior surface than in those implanted only with decellularized laminas (G-2).
","['humans using injected autologous adipose-derived adult stem cells (ADASCs) and corneal decellularized laminas in corneas with advanced keratoconus', '14 keratoconic patients', 'Adipose Mesenchymal Stem Cells and Corneal Laminas']","['surgical interventions: group 1 (G-1), autologous ADASC implantation (n = 5); group 2 (G-2), decellularized human corneal stroma (n = 5); and group 3 (G-3), autologous ADASCs + decellularized human corneal stroma (n = 4']","['cell density of patients receiving ADASC recellularized laminas (G-3', 'cell density']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1636199', 'cui_str': 'Adipose derived adult stem cell'}, {'cui': 'C0010031', 'cui_str': 'Corneal structure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0010040', 'cui_str': 'Structure of substantia propria of cornea'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1636199', 'cui_str': 'Adipose derived adult stem cell'}]","[{'cui': 'C0162339', 'cui_str': 'Cell Density'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]",14.0,0.0181501,"The cell density of patients receiving ADASC recellularized laminas (G-3) was statistically significantly higher (P = 0.011) at the anterior surface and within the lamina (P = 0.029) and at the posterior surface than in those implanted only with decellularized laminas (G-2).
","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'El Zarif', 'Affiliation': ',.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'A Jawad', 'Affiliation': ',.'}, {'ForeName': 'Jorge L', 'Initials': 'JL', 'LastName': 'Alió Del Barrio', 'Affiliation': ',.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'A Jawad', 'Affiliation': ',.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Palazón-Bru', 'Affiliation': ',.'}, {'ForeName': 'María P', 'Initials': 'MP', 'LastName': 'de Miguel', 'Affiliation': ',.'}, {'ForeName': 'Peggy', 'Initials': 'P', 'LastName': 'Saba', 'Affiliation': ',.'}, {'ForeName': 'Nehman', 'Initials': 'N', 'LastName': 'Makdissy', 'Affiliation': ',.'}, {'ForeName': 'Jorge L', 'Initials': 'JL', 'LastName': 'Alió', 'Affiliation': ',.'}]",Investigative ophthalmology & visual science,['10.1167/iovs.61.4.22']
188,30667591,Pharmacokinetics of Once-Daily Extended-Release Tacrolimus Tablets Versus Twice-Daily Capsules in De Novo Liver Transplant.,"The pharmacokinetics of once-daily extended-release tacrolimus tablets (LCPT) in de novo liver transplantation have not been previously reported. In this phase II, randomized, open-label study, de novo liver transplant recipients were randomized to LCPT 0.07-0.13 mg/kg/day (taken once daily; n = 29) or twice-daily immediate-release tacrolimus capsules (IR-Tac) at 0.10-0.15 mg/kg/day (divided twice daily; n = 29). Subsequent doses of both drugs were adjusted to maintain tacrolimus trough concentrations of 5 to 20 ng/mL through day 90, and 5-15 ng/mL thereafter. Twenty-four-hour pharmacokinetic profiles were obtained on days 1, 7, and 14, with trough concentration and efficacy/safety monitoring through year 1. Similar proportions of patients in both groups achieved therapeutic trough concentrations on days 7 and 14 (day 7: LCPT = 78%, IR-Tac = 75%; day 14: LCPT = 86%, IR-Tac = 91%) as well as similar systemic and peak exposure. There was a robust correlation between drug concentration at time 0 and area under the concentration-time curve for both LCPT and IR-Tac (respectively, day 7: r = 0.86 and 0.79; day 14: r = 0.93 and 0.86; P < .0001 for all). Dose adjustments during days 1 to 14 were frequent. Thirty-five patients completed the extended-use period. No significant differences in adverse events were seen between groups. Incidence of biopsy-proven acute rejection (LCPT = 6 and IR-Tac = 4) was similar on day 360. Between formulations, overall exposure was similar at 1 week after transplant with the characteristic delayed-release pharmacokinetic profile of LCPT demonstrated in this novel population. These data support further investigation of the safety and efficacy of LCPT in de novo liver transplantation.",2019,"Between formulations, overall exposure was similar at 1 week after transplant with the characteristic delayed-release pharmacokinetic profile of LCPT demonstrated in this novel population.","['De Novo Liver Transplant', 'de novo liver transplant recipients']","['tacrolimus tablets (LCPT', 'Pharmacokinetics of Once-Daily Extended-Release Tacrolimus Tablets Versus Twice-Daily Capsules', 'LCPT', 'twice-daily immediate-release tacrolimus capsules']","['adverse events', 'therapeutic trough concentrations', 'drug concentration at time 0 and area under the concentration-time curve']","[{'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C3811922', 'cui_str': 'Transplanted liver present (finding)'}]","[{'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",360.0,0.0258007,"Between formulations, overall exposure was similar at 1 week after transplant with the characteristic delayed-release pharmacokinetic profile of LCPT demonstrated in this novel population.","[{'ForeName': 'Derek A', 'Initials': 'DA', 'LastName': 'DuBay', 'Affiliation': 'Medical University of South Carolina, Department of Surgery, Charleston, SC, USA.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Teperman', 'Affiliation': 'Northwell Health, Manhasset, NY, USA.'}, {'ForeName': 'Kimi', 'Initials': 'K', 'LastName': 'Ueda', 'Affiliation': 'California Pacific Medical Center, San Francisco, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Silverman', 'Affiliation': 'Tampa General Hospital, Department of Pharmacy, Tampa, FL, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chapman', 'Affiliation': 'Washington University School of Medicine, Department of Surgery, St Louis, MO, USA.'}, {'ForeName': 'Angel E', 'Initials': 'AE', 'LastName': 'Alsina', 'Affiliation': 'Tampa General Hospital, Division of Transplantation, Tampa, FL, USA.'}, {'ForeName': 'Carmelina', 'Initials': 'C', 'LastName': 'Tyler', 'Affiliation': 'Veloxis Pharmaceuticals, Inc., Cary, NC, USA.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Stevens', 'Affiliation': 'Veloxis Pharmaceuticals, Inc., Cary, NC, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.657']
189,32238507,Telephone-based cognitive behavioral therapy for depression in Parkinson disease: A randomized controlled trial.,"OBJECTIVE


To determine whether, for patients with depression and Parkinson disease (PD), telephone-based cognitive-behavioral treatment (T-CBT) alleviates depressive symptoms significantly more than treatment as usual (TAU), we conducted a randomized controlled trial to evaluate the efficacy of a 10-session T-CBT intervention for depression in PD, compared to TAU.
METHODS


Seventy-two people with PD (PWP) were randomized to T-CBT + TAU or TAU only. T-CBT tailored to PWPs' unique needs was provided weekly for 3 months, then monthly during 6-month follow-up. CBT targeted negative thoughts (e.g., ""I have no control""; ""I am helpless"") and behaviors (e.g., social withdrawal, excessive worry). It also trained care partners to help PWP practice healthy habits. Blind raters assessed outcomes at baseline, midtreatment, treatment end, and 1 and 6 months post-treatment. Analyses were intent to treat.
RESULTS


T-CBT outperformed TAU on all depression, anxiety, and quality of life measures. The primary outcome (Hamilton Depression Rating Scale score) improved significantly in T-CBT compared to TAU by treatment end. Mean improvement from baseline was 6.53 points for T-CBT and -0.27 points for TAU ( p  < 0.0001); gains persisted over 6-month follow-up ( p  < 0.0001). Improvements were moderated by a reduction in negative thoughts in the T-CBT group only, reflecting treatment target engagement.
CONCLUSIONS


T-CBT may be an effective depression intervention that addresses a significant unmet PD treatment need and bypasses access barriers to multidisciplinary, evidence-based care.
CLINICALTRIALSGOV IDENTIFIER


NCT02505737.
CLASSIFICATION OF EVIDENCE


This study provides Class I evidence that for patients with depression and PD, T-CBT significantly alleviated depressive symptoms compared to usual care.",2020,Mean improvement from baseline was 6.53 points for T-CBT and -0.27 points for TAU ( p  < 0.0001); gains persisted over 6-month follow-up ( p  < 0.0001).,"['patients with depression and Parkinson disease (PD), telephone-based cognitive-behavioral treatment (T-CBT) alleviates depressive symptoms significantly more than treatment as usual (TAU', 'Parkinson disease', 'Seventy-two people with PD (PWP']","['10-session T-CBT intervention', 'T-CBT + TAU or TAU', 'Telephone-based cognitive behavioral therapy']","['depressive symptoms', 'negative thoughts', 'depression, anxiety, and quality of life measures', 'primary outcome (Hamilton Depression Rating Scale score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1142075', 'cui_str': 'Negative thoughts'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",72.0,0.0946385,Mean improvement from baseline was 6.53 points for T-CBT and -0.27 points for TAU ( p  < 0.0001); gains persisted over 6-month follow-up ( p  < 0.0001).,"[{'ForeName': 'Roseanne D', 'Initials': 'RD', 'LastName': 'Dobkin', 'Affiliation': 'From the Departments of Psychiatry (R.D.D., M.A.G., K.M.R., M.M.) and Neurology (M.M.), Rutgers-Robert Wood Johnson Medical School, Piscataway; and VA New Jersey Health Care System (R.D.D., S.L.M., A.I.), Lyons. dobkinro@rutgers.edu.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Mann', 'Affiliation': 'From the Departments of Psychiatry (R.D.D., M.A.G., K.M.R., M.M.) and Neurology (M.M.), Rutgers-Robert Wood Johnson Medical School, Piscataway; and VA New Jersey Health Care System (R.D.D., S.L.M., A.I.), Lyons.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gara', 'Affiliation': 'From the Departments of Psychiatry (R.D.D., M.A.G., K.M.R., M.M.) and Neurology (M.M.), Rutgers-Robert Wood Johnson Medical School, Piscataway; and VA New Jersey Health Care System (R.D.D., S.L.M., A.I.), Lyons.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Interian', 'Affiliation': 'From the Departments of Psychiatry (R.D.D., M.A.G., K.M.R., M.M.) and Neurology (M.M.), Rutgers-Robert Wood Johnson Medical School, Piscataway; and VA New Jersey Health Care System (R.D.D., S.L.M., A.I.), Lyons.'}, {'ForeName': 'Kailyn M', 'Initials': 'KM', 'LastName': 'Rodriguez', 'Affiliation': 'From the Departments of Psychiatry (R.D.D., M.A.G., K.M.R., M.M.) and Neurology (M.M.), Rutgers-Robert Wood Johnson Medical School, Piscataway; and VA New Jersey Health Care System (R.D.D., S.L.M., A.I.), Lyons.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Menza', 'Affiliation': 'From the Departments of Psychiatry (R.D.D., M.A.G., K.M.R., M.M.) and Neurology (M.M.), Rutgers-Robert Wood Johnson Medical School, Piscataway; and VA New Jersey Health Care System (R.D.D., S.L.M., A.I.), Lyons.'}]",Neurology,['10.1212/WNL.0000000000009292']
190,32317575,Forgot calcium? Admission ionized-calcium in two civilian randomized controlled trials of prehospital plasma for traumatic hemorrhagic shock.,"BACKGROUND


Randomized clinical trials (RCTs) support the use of prehospital plasma in traumatic hemorrhagic shock, especially in long transports. The citrate added to plasma binds with calcium, yet most prehospital trauma protocols have no guidelines for calcium replacement. We reviewed the experience of two recent prehospital plasma RCTs regarding admission ionized-calcium (i-Ca) blood levels and its impact on survival. We hypothesized that prehospital plasma is associated with hypocalcemia, which in turn is associated with lower survival.
METHODS


We studied patients enrolled in two institutions participating in prehospital plasma RCTs (control, standard of care; experimental, plasma), with i-Ca collected before calcium supplementation. Adults with traumatic hemorrhagic shock (systolic blood pressure ≤70 mm Hg or 71-90 mm Hg + heart rate ≥108 bpm) were eligible. We use generalized linear mixed models with random intercepts and Cox proportional hazards models with robust standard errors to account for clustered data by institution. Hypocalcemia was defined as i-Ca of 1.0 mmol/L or less.
RESULTS


Of 160 subjects (76% men), 48% received prehospital plasma (median age, 40 years [interquartile range, 28-53 years]) and 71% suffered blunt trauma (median Injury Severity Score [ISS], 22 [interquartile range, 17-34]). Prehospital plasma and control patients were similar regarding age, sex, ISS, blunt mechanism, and brain injury. Prehospital plasma recipients had significantly higher rates of hypocalcemia compared with controls (53% vs. 36%; adjusted relative risk, 1.48; 95% confidence interval [CI], 1.03-2.12; p = 0.03). Severe hypocalcemia was significantly associated with decreased survival (adjusted hazard ratio, 1.07; 95% CI, 1.02-1.13; p = 0.01) and massive transfusion (adjusted relative risk, 2.70; 95% CI, 1.13-6.46; p = 0.03), after adjustment for confounders (randomization group, age, ISS, and shock index).
CONCLUSION


Prehospital plasma in civilian trauma is associated with hypocalcemia, which in turn predicts lower survival and massive transfusion. These data underscore the need for explicit calcium supplementation guidelines in prehospital hemotherapy.
LEVEL OF EVIDENCE


Therapeutic, level II.",2020,"Prehospital plasma recipients had significantly higher rates of hypocalcemia compared with controls (53% vs. 36%; adjusted relative risk, 1.48; 95% confidence interval [CI], 1.03-2.12; p = 0.03).","['160 subjects (76% men', 'Adults with traumatic hemorrhagic shock (systolic blood pressure ≤70 mm Hg or 71-90 mm Hg + heart rate ≥108 bpm) were eligible', ' 48% received prehospital plasma (median age, 40 years [interquartile range, 28-53 years]) and 71% suffered blunt trauma (median Injury Severity Score [ISS], 22 [interquartile range, 17-34', 'traumatic hemorrhagic shock', 'We studied patients enrolled in two institutions participating in prehospital plasma RCTs (control, standard of care; experimental, plasma), with i-Ca collected before calcium supplementation']",[],"['massive transfusion', 'survival', 'Severe hypocalcemia', 'rates of hypocalcemia', 'Hypocalcemia']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0036982', 'cui_str': 'Hemorrhagic shock'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043253', 'cui_str': 'Blunt injury'}, {'cui': 'C0021504', 'cui_str': 'Injury severity score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0373561', 'cui_str': 'Calcium electrolyte'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1096745', 'cui_str': 'Calcium supplement therapy'}]",[],"[{'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}]",160.0,0.491442,"Prehospital plasma recipients had significantly higher rates of hypocalcemia compared with controls (53% vs. 36%; adjusted relative risk, 1.48; 95% confidence interval [CI], 1.03-2.12; p = 0.03).","[{'ForeName': 'Hunter B', 'Initials': 'HB', 'LastName': 'Moore', 'Affiliation': 'From the School of Medicine, Department of Surgery, University of Colorado Anschutz Medical Campus (H.B.M., E.E.M., M.J.C., M.P.C., A.S.), Aurora, CO; University of Colorado Anschutz Medical Campus, School of Public Health, Department of Health Systems, Management and Policy (A.S.); Aurora, Colorado; University of Pittsburgh (M.T.T., J.L.S., F.X.G., J.B.B., M.N., B.Z.), Pittsburgh, Pennsylvania; Ernest E. Moore Shock Trauma Center at Denver Health (E.E.M., M.J.C.), Denver, Colorado; and Combat Casualty Care Research Program (A.E.P.), US Army Medical Research Materiel Command, Fort Detrick, Maryland.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Tessmer', 'Affiliation': ''}, {'ForeName': 'Ernest E', 'Initials': 'EE', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Sperry', 'Affiliation': ''}, {'ForeName': 'Mitchell J', 'Initials': 'MJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Chapman', 'Affiliation': ''}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Pusateri', 'Affiliation': ''}, {'ForeName': 'Francis X', 'Initials': 'FX', 'LastName': 'Guyette', 'Affiliation': ''}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': ''}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Zuckerbraun', 'Affiliation': ''}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sauaia', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002614']
191,30786162,"A Phase 3, Randomized, Placebo-Controlled Evaluation of the Safety of Intravenous Meloxicam Following Major Surgery.","An intravenous (IV) formulation of meloxicam is being studied for moderate to severe pain management. This phase 3, randomized, multicenter, double-blind, placebo-controlled trial evaluated the safety of once-daily meloxicam IV 30 mg in subjects following major elective surgery. Eligible subjects were randomized (3:1) to receive meloxicam IV 30 mg or placebo administered once daily. Safety was evaluated via adverse events, clinical laboratory tests, vital signs, wound healing, and opioid consumption. The incidence of adverse events was similar between meloxicam IV- and placebo-treated subjects (63.0% versus 65.0%). Investigators assessed most adverse events as mild or moderate in intensity and unrelated to treatment. Adverse events of interest (injection-site reactions, bleeding, cardiovascular, hepatic, renal, thrombotic, and wound-healing events) were similar between groups. Over the treatment period, meloxicam IV was associated with a 23.6% (P = .0531) reduction in total opioid use (9.2 mg morphine equivalent) compared to placebo-treated subjects. The results suggest that meloxicam IV had a safety profile similar to that of placebo with respect to numbers and frequencies of adverse events and reduced opioid consumption in subjects with moderate to severe postoperative pain following major elective surgery.",2019,"Over the treatment period, meloxicam IV was associated with a 23.6% (P = .0531) reduction in total opioid use (9.2 mg morphine equivalent) compared to placebo-treated subjects.","['Eligible subjects', 'subjects following major elective surgery', 'subjects with moderate to severe postoperative pain following major elective surgery']","['placebo', 'meloxicam IV', 'Placebo', 'meloxicam', 'Meloxicam', 'meloxicam IV 30 mg or placebo']","['adverse events, clinical laboratory tests, vital signs, wound healing, and opioid consumption', 'Adverse events of interest (injection-site reactions, bleeding, cardiovascular, hepatic, renal, thrombotic, and wound-healing events', 'total opioid use', 'incidence of adverse events', 'numbers and frequencies of adverse events and reduced opioid consumption']","[{'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0083381', 'cui_str': 'meloxicam'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0518766'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0043187', 'cui_str': 'Wind'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",,0.421191,"Over the treatment period, meloxicam IV was associated with a 23.6% (P = .0531) reduction in total opioid use (9.2 mg morphine equivalent) compared to placebo-treated subjects.","[{'ForeName': 'Sergio D', 'Initials': 'SD', 'LastName': 'Bergese', 'Affiliation': 'The Ohio State University, Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Timothy I', 'Initials': 'TI', 'LastName': 'Melson', 'Affiliation': 'Helen Keller Hospital, Shoals Medical Trials, Inc, Sheffield, AL, USA.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Candiotti', 'Affiliation': 'University of Miami, Jackson Memorial Hospital, Miami, FL, USA.'}, {'ForeName': 'Sabry S', 'Initials': 'SS', 'LastName': 'Ayad', 'Affiliation': 'Cleveland Clinic Fairview Hospital, Anesthesiology Institute, Outcomes Research, Cleveland, OH, USA.'}, {'ForeName': 'Randall J', 'Initials': 'RJ', 'LastName': 'Mack', 'Affiliation': 'Recro Pharma, Inc, Malvern, PA, USA.'}, {'ForeName': 'Stewart W', 'Initials': 'SW', 'LastName': 'McCallum', 'Affiliation': 'Recro Pharma, Inc, Malvern, PA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Du', 'Affiliation': 'Clinical Statistics Consulting, Blue Bell, PA, USA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Gomez', 'Affiliation': 'Recro Pharma, Inc, Malvern, PA, USA.'}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Marcet', 'Affiliation': 'Tampa General Hospital, Tampa, FL, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.666']
192,32311072,Pharmacological treatment for familial amyloid polyneuropathy.,"BACKGROUND


Disease-modifying pharmacological agents for transthyretin (TTR)-related familial amyloid polyneuropathy (FAP) have become available in the last decade, but evidence on their efficacy and safety is limited. This review focuses on disease-modifying pharmacological treatment for TTR-related and other FAPs, encompassing amyloid kinetic stabilisers, amyloid matrix solvents, and amyloid precursor inhibitors.
OBJECTIVES


To assess and compare the efficacy, acceptability, and tolerability of disease-modifying pharmacological agents for familial amyloid polyneuropathies (FAPs).
SEARCH METHODS


On 18 November 2019, we searched the Cochrane Neuromuscular Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase. We reviewed reference lists of articles and textbooks on peripheral neuropathies. We also contacted experts in the field. We searched clinical trials registries and manufacturers' websites.
SELECTION CRITERIA


We included randomised clinical trials (RCTs) or quasi-RCTs investigating any disease-modifying pharmacological agent in adults with FAPs. Disability due to FAP progression was the primary outcome. Secondary outcomes were severity of peripheral neuropathy, change in modified body mass index (mBMI), quality of life, severity of depression, mortality, and adverse events during the trial.
DATA COLLECTION AND ANALYSIS


We followed standard Cochrane methodology.
MAIN RESULTS


The review included four RCTs involving 655 people with TTR-FAP. The manufacturers of the drugs under investigation funded three of the studies. The trials investigated different drugs versus placebo and we did not conduct a meta-analysis. One RCT compared tafamidis with placebo in early-stage TTR-FAP (128 randomised participants). The trial did not explore our predetermined disability outcome measures. After 18 months, tafamidis might reduce progression of peripheral neuropathy slightly more than placebo (Neuropathy Impairment Score (NIS) in the lower limbs; mean difference (MD) -3.21 points, 95% confidential interval (CI) -5.63 to -0.79; P = 0.009; low-certainty evidence). However, tafamidis might lead to little or no difference in the change of quality of life between groups (Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) total score; MD -4.50 points, 95% CI -11.27 to 2.27; P = 0.19; very low-certainty evidence). No clear between-group difference was found in the numbers of participants who died (risk ratio (RR) 0.65, 95% CI 0.11 to 3.74; P = 0.63; very low-certainty evidence), who dropped out due to adverse events (RR 1.29, 95% CI 0.30 to 5.54; P = 0.73; very low-certainty evidence), or who experienced at least one severe adverse event during the trial (RR 1.16, 95% CI 0.37 to 3.62; P = 0.79; very low-certainty evidence). One RCT compared diflunisal with placebo (130 randomised participants). At month 24, diflunisal might reduce progression of disability (Kumamoto Score; MD -4.90 points, 95% CI -7.89 to -1.91; P = 0.002; low-certainty evidence) and peripheral neuropathy (NIS plus 7 nerve tests; MD -18.10 points, 95% CI -26.03 to -10.17; P < 0.001; low-certainty evidence) more than placebo. After 24 months, changes from baseline in the quality of life measured by the 36-Item Short-Form Health Survey score showed no clear difference between groups for the physical component (MD 6.10 points, 95% CI 2.56 to 9.64; P = 0.001; very low-certainty evidence) and the mental component (MD 4.40 points, 95% CI -0.19 to 8.99; P = 0.063; very low-certainty evidence). There was no clear between-group difference in the number of people who died (RR 0.46, 95% CI 0.15 to 1.41; P = 0.17; very low-certainty evidence), in the number of dropouts due to adverse events (RR 2.06, 95% CI 0.39 to 10.87; P = 0.39; very low-certainty evidence), and in the number of people who experienced at least one severe adverse event (RR 0.77, 95% CI 0.18 to 3.32; P = 0.73; very low-certainty evidence) during the trial. One RCT compared patisiran with placebo (225 randomised participants). After 18 months, patisiran reduced both progression of disability (Rasch-built Overall Disability Scale; least-squares MD 8.90 points, 95% CI 7.00 to 10.80; P < 0.001; moderate-certainty evidence) and peripheral neuropathy (modified NIS plus 7 nerve tests - Alnylam version; least-squares MD -33.99 points, 95% CI -39.86 to -28.13; P < 0.001; moderate-certainty evidence) more than placebo. At month 18, the change in quality of life between groups favoured patisiran (Norfolk QOL-DN total score; least-squares MD -21.10 points, 95% CI -27.20 to -15.00; P < 0.001; low-certainty evidence). There was little or no between-group difference in the number of participants who died (RR 0.61, 95% CI 0.21 to 1.74; P = 0.35; low-certainty evidence), dropped out due to adverse events (RR 0.33, 95% CI 0.13 to 0.82; P = 0.017; low-certainty evidence), or experienced at least one severe adverse event (RR 0.91, 95% CI 0.64 to 1.28; P = 0.58; low-certainty evidence) during the trial. One RCT compared inotersen with placebo (172 randomised participants). The trial did not explore our predetermined disability outcome measures. From baseline to week 66, inotersen reduced progression of peripheral neuropathy more than placebo (modified NIS plus 7 nerve tests - Ionis version; MD -19.73 points, 95% CI -26.50 to -12.96; P < 0.001; moderate-certainty evidence). At week 65, the change in quality of life between groups favoured inotersen (Norfolk QOL-DN total score; MD -10.85 points, 95% CI -17.25 to -4.45; P < 0.001; low-certainty evidence). Inotersen may slightly increase mortality (RR 5.94, 95% CI 0.33 to 105.60; P = 0.22; low-certainty evidence) and occurrence of severe adverse events (RR 1.48, 95% CI 0.85 to 2.57; P = 0.16; low-certainty evidence) compared to placebo. More dropouts due to adverse events were observed in the inotersen than in the placebo group (RR 8.57, 95% CI 1.16 to 63.07; P = 0.035; low-certainty evidence). There were no studies addressing apolipoprotein AI-FAP, gelsolin-FAP, and beta-2-microglobulin-FAP.
AUTHORS' CONCLUSIONS


Evidence on the pharmacological treatment of FAPs from RCTs is limited to TTR-FAP. No studies directly compare disease-modifying pharmacological treatments for TTR-FAP. Results from placebo-controlled trials indicate that tafamidis, diflunisal, patisiran, and inotersen may be beneficial in TTR-FAP, but further investigations are needed. Since direct comparative studies for TTR-FAP will be hampered by sample size and costs required to demonstrate superiority of one drug over another, long-term non-randomised open-label studies monitoring their efficacy and safety are needed.",2020,"Inotersen may slightly increase mortality (RR 5.94, 95% CI 0.33 to 105.60; P = 0.22; low-certainty evidence) and occurrence of severe adverse events (RR 1.48, 95% CI 0.85 to 2.57; P = 0.16; low-certainty evidence) compared to placebo.","['655 people with TTR-FAP', 'familial amyloid polyneuropathy', 'familial amyloid polyneuropathies (FAPs', 'adults with FAPs']","['placebo', 'diflunisal with placebo', 'quasi-RCTs', 'diflunisal']","['adverse events', 'efficacy, acceptability, and tolerability', 'peripheral neuropathy', 'severity of peripheral neuropathy, change in modified body mass index (mBMI), quality of life, severity of depression, mortality, and adverse events', 'apolipoprotein AI-FAP, gelsolin-FAP, and beta-2-microglobulin-FAP', 'number of participants who died', 'severe adverse event', 'progression of disability', 'number of people who died', 'progression of peripheral neuropathy', 'mortality', 'progression of disability (Rasch-built Overall Disability Scale', 'occurrence of severe adverse events', 'quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0206245', 'cui_str': 'Familial amyloid polyneuropathy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012228', 'cui_str': 'Diflunisal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0206245', 'cui_str': 'Familial amyloid polyneuropathy'}, {'cui': 'C0061187', 'cui_str': 'Gelsolin'}, {'cui': 'C0005149', 'cui_str': 'Beta 2 microglobulin'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",655.0,0.543706,"Inotersen may slightly increase mortality (RR 5.94, 95% CI 0.33 to 105.60; P = 0.22; low-certainty evidence) and occurrence of severe adverse events (RR 1.48, 95% CI 0.85 to 2.57; P = 0.16; low-certainty evidence) compared to placebo.","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Magrinelli', 'Affiliation': 'University of Verona, Department of Neurosciences, Biomedicine and Movement Sciences, Piazzale L.A. Scuro n. 10, Verona, VR, Italy, 37134.'}, {'ForeName': 'Gian Maria', 'Initials': 'GM', 'LastName': 'Fabrizi', 'Affiliation': 'University of Verona, Department of Neurosciences, Biomedicine and Movement Sciences, Piazzale L.A. Scuro n. 10, Verona, VR, Italy, 37134.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Santoro', 'Affiliation': 'University Federico II of Naples, Department of Neurosciences, Reproductive Sciences and Odontostomatology, Via Sergio Pansini n. 5, Naples, Italy, 80131.'}, {'ForeName': 'Fiore', 'Initials': 'F', 'LastName': 'Manganelli', 'Affiliation': 'University Federico II of Naples, Department of Neurosciences, Reproductive Sciences and Odontostomatology, Via Sergio Pansini n. 5, Naples, Italy, 80131.'}, {'ForeName': 'Giampietro', 'Initials': 'G', 'LastName': 'Zanette', 'Affiliation': 'Pederzoli Hospital, Neurology Section, Via Monte Baldo n° 24, Peschiera del Garda, VR, Italy, 37019.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Cavallaro', 'Affiliation': 'University of Verona, Department of Neurosciences, Biomedicine and Movement Sciences, Piazzale L.A. Scuro n. 10, Verona, VR, Italy, 37134.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tamburin', 'Affiliation': 'University of Verona, Department of Neurosciences, Biomedicine and Movement Sciences, Piazzale L.A. Scuro n. 10, Verona, VR, Italy, 37134.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012395.pub2']
193,32067585,Noninvasive Imaging Estimation of Myocardial Iron Repletion Following Administration of Intravenous Iron: The Myocardial-IRON Trial.,"Background Intravenous ferric carboxymaltose (FCM) improves symptoms, functional capacity, and quality of life in heart failure and iron deficiency. The mechanisms underlying these effects are not fully understood. The aim of this study was to examine changes in myocardial iron content after FCM administration in patients with heart failure and iron deficiency using cardiac magnetic resonance. Methods and Results Fifty-three stable heart failure and iron deficiency patients were randomly assigned 1:1 to receive intravenous FCM or placebo in a multicenter, double-blind study. T2* and T1 mapping cardiac magnetic resonance sequences, noninvasive surrogates of intramyocardial iron, were evaluated before and 7 and 30 days after randomization using linear mixed regression analysis. Results are presented as least-square means with 95% CI. The primary end point was the change in T2* and T1 mapping at 7 and 30 days. Median age was 73 (65-78) years, with N-terminal pro-B-type natriuretic peptide, ferritin, and transferrin saturation medians of 1690 pg/mL (1010-2828), 63 ng/mL (22-114), and 15.7% (11.0-19.2), respectively. Baseline T2* and T1 mapping values did not significantly differ across treatment arms. On day 7, both T2* and T1 mapping (ms) were significantly lower in the FCM arm (36.6 [34.6-38.7] versus 40 [38-42.1],  P =0.025; 1061 [1051-1072] versus 1085 [1074-1095],  P =0.001, respectively). A similar reduction was found at 30 days for T2* (36.3 [34.1-38.5] versus 41.1 [38.9-43.4],  P =0.003), but not for T1 mapping (1075 [1065-1085] versus 1079 [1069-1089],  P =0.577). Conclusions In patients with heart failure and iron deficiency, FCM administration was associated with changes in the T2* and T1 mapping cardiac magnetic resonance sequences, indicative of myocardial iron repletion. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03398681.",2020,"On day 7, both T2* and T1 mapping (ms) were significantly lower in the FCM arm (36.6 [34.6-38.7] versus 40","['patients with heart failure and iron deficiency using cardiac magnetic resonance', 'patients with heart failure and iron deficiency', 'Median age was 73 (65-78) years, with N-terminal pro-B-type natriuretic peptide, ferritin, and transferrin saturation medians of 1690\xa0pg/mL', 'Methods and Results Fifty-three stable heart failure and iron deficiency patients']","['intravenous FCM or placebo', 'Intravenous Iron', ' Intravenous ferric carboxymaltose (FCM', 'FCM']","['myocardial iron content', 'symptoms, functional capacity, and quality of life in heart failure and iron deficiency']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0240066', 'cui_str': 'Iron deficiency (disorder)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation index (procedure)'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0034380'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0240066', 'cui_str': 'Iron deficiency (disorder)'}]",53.0,0.677504,"On day 7, both T2* and T1 mapping (ms) were significantly lower in the FCM arm (36.6 [34.6-38.7] versus 40","[{'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Núñez', 'Affiliation': 'Cardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Miñana', 'Affiliation': 'Cardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia Spain.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Cardells', 'Affiliation': 'Cardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Palau', 'Affiliation': 'Cardiology Department Hospital General de Castellón Universitat Jaume I Castellón Spain.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Llàcer', 'Affiliation': 'Internal Medicine Department Hospital de Manises Manises Spain.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Fácila', 'Affiliation': 'Cardiology Department Hospital General Universitario de Valencia Valencia Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Almenar', 'Affiliation': 'Cardiology Department Hospital Universitario La Fe de Valencia Valencia Spain.'}, {'ForeName': 'Maria P', 'Initials': 'MP', 'LastName': 'López-Lereu', 'Affiliation': 'Unidad de Imagen Cardiaca (ERESA) Hospital Clínico Universitario de Valencia Valencia Spain.'}, {'ForeName': 'Jose V', 'Initials': 'JV', 'LastName': 'Monmeneu', 'Affiliation': 'Unidad de Imagen Cardiaca (ERESA) Hospital Clínico Universitario de Valencia Valencia Spain.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Amiguet', 'Affiliation': 'Cardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia Spain.'}, {'ForeName': 'Jessika', 'Initials': 'J', 'LastName': 'González', 'Affiliation': 'Cardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Serrano', 'Affiliation': 'Cardiology Department Hospital General de Castellón Universitat Jaume I Castellón Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Montagud', 'Affiliation': 'Cardiology Department Hospital General Universitario de Valencia Valencia Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'López-Vilella', 'Affiliation': 'Cardiology Department Hospital Universitario La Fe de Valencia Valencia Spain.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Valero', 'Affiliation': 'Cardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'García-Blas', 'Affiliation': 'Cardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia Spain.'}, {'ForeName': 'Vicent', 'Initials': 'V', 'LastName': 'Bodí', 'Affiliation': 'Cardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'de la Espriella-Juan', 'Affiliation': 'Cardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Lupón', 'Affiliation': 'CIBER Cardiovascular Universitat Jaume I Castellón Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': 'Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Górriz', 'Affiliation': 'Nephrology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Sanchis', 'Affiliation': 'Cardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Chorro', 'Affiliation': 'Cardiology Department Hospital Clínico Universitario de Valencia Universidad de Valencia INCLIVA Valencia Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Comín-Colet', 'Affiliation': 'Department of Cardiology Hospital del Mar Barcelona Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Bayés-Genís', 'Affiliation': 'CIBER Cardiovascular Universitat Jaume I Castellón Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.119.014254']
194,32067595,Effects of Isometric Handgrip Training in Patients With Peripheral Artery Disease: A Randomized Controlled Trial.,"Background Meta-analyses have shown that isometric handgrip training (IHT) can reduce brachial systolic and diastolic blood pressure (BP) by >6/4 mm Hg, respectively. However, whether IHT promotes these effects among patients with peripheral artery disease, who exhibit severe impairment in cardiovascular function, is currently unknown. This study aimed to evaluate the effects of IHT on the cardiovascular function of patients with peripheral artery disease. Methods and Results A randomized controlled trial with peripheral artery disease patients assigned to either the IHT or control group was conducted. The IHT group performed 3 sessions per week, for 8 weeks, of unilateral handgrip exercises, consisting of 4 sets of isometric contractions for 2 minutes at 30% of maximum voluntary contraction and a 4-minute interval between sets. The control group received a compression ball in order to minimize the placebo effects, representing sham training. The primary outcome was brachial BP. The secondary outcomes were central BP, arterial stiffness parameters, cardiac autonomic modulation, and vascular function. The IHT program reduced diastolic BP (75 [10] mm Hg preintervention versus 72 [11] mm Hg postintervention), with no change in the control group (74 [11] mm Hg preintervention versus 74 [11] mm Hg postintervention), with this between-group difference being significant ( P =0.04). Flow-mediated dilation improved in the IHT group (6.0% [5.7] preintervention versus 9.7% [5.5] postintervention), with no change in the control group (7.6% [5.5] preintervention versus 7.4% [5.1] postintervention), with this between-group difference being significant ( P =0.04). There was no change in other measured variables over the intervention period. Conclusions IHT reduced brachial diastolic BP and improved local vascular function in patients with peripheral artery disease. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02742220.",2020,"Flow-mediated dilation improved in the IHT group (6.0% [5.7] preintervention versus 9.7% [5.5] postintervention), with no change in the control group (7.6% [5.5] preintervention versus 7.4% [5.1] postintervention), with this between-group difference being significant ( P =0.04).","['Patients With Peripheral Artery Disease', 'patients with peripheral artery disease', 'peripheral artery disease patients']","['unilateral handgrip exercises', 'IHT or control', 'IHT', 'Isometric Handgrip Training', 'isometric handgrip training (IHT', 'compression ball']","['brachial BP', 'brachial systolic and diastolic blood pressure (BP', 'diastolic BP', 'central BP, arterial stiffness parameters, cardiac autonomic modulation, and vascular function', 'Flow-mediated dilation', 'local vascular function', 'brachial diastolic BP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}]","[{'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]",,0.228251,"Flow-mediated dilation improved in the IHT group (6.0% [5.7] preintervention versus 9.7% [5.5] postintervention), with no change in the control group (7.6% [5.5] preintervention versus 7.4% [5.1] postintervention), with this between-group difference being significant ( P =0.04).","[{'ForeName': 'Marilia', 'Initials': 'M', 'LastName': 'A Correia', 'Affiliation': 'Associated Graduated Program in Physical Education Universidade de Pernambuco e Universidade da Paraíba Recife Brazil.'}, {'ForeName': 'Paulo L', 'Initials': 'PL', 'LastName': 'Oliveira', 'Affiliation': 'Graduated Program in Rehabilitation Sciences Universidade Nove de Julho São Paulo Brazil.'}, {'ForeName': 'Breno Q', 'Initials': 'BQ', 'LastName': 'Farah', 'Affiliation': 'Federal Rural University of Pernambuco Recife Brazil.'}, {'ForeName': 'Lauro C', 'Initials': 'LC', 'LastName': 'Vianna', 'Affiliation': 'Faculty of Physical Education Universidade de Brasília Brasília Brazil.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Wolosker', 'Affiliation': 'Hospital Israelita Albert Einstein São Paulo Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Puech-Leao', 'Affiliation': 'Faculty of Medicine University of São Paulo Brazil.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'The University of Western Australia Perth Australia.'}, {'ForeName': 'Gabriel G', 'Initials': 'GG', 'LastName': 'Cucato', 'Affiliation': 'Hospital Israelita Albert Einstein São Paulo Brazil.'}, {'ForeName': 'Raphael M', 'Initials': 'RM', 'LastName': 'Ritti-Dias', 'Affiliation': 'Graduated Program in Rehabilitation Sciences Universidade Nove de Julho São Paulo Brazil.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.013596']
195,31033154,Comparison of long-term clinical outcomes in multivessel coronary artery disease patients treated either with bioresoarbable polymer sirolimus-eluting stent or permanent polymer everolimus-eluting stent: 5-year results of the CENTURY II randomized clinical trial.,"OBJECTIVES


To assess the long-term safety and efficacy of a sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster), in comparison to a benchmark everolimus-eluting, permanent polymer stent (PP-EES; Xience), in a prespecified subgroup of patients with multivessel coronary artery disease (MVD) enrolled in the CENTURY II trial.
BACKGROUND


The use of coronary stenting in high-risk subgroups, like MVD patients, is rising. The clinical evidence, including long-term comparative analysis of the efficacy and safety benefits of different new-generation drug eluting stents, however, remains insufficient.
METHODS


Among 1,119 patients (intention-to-treat) enrolled in the CENTURY II prospective, randomized, single-blind, multicenter trial, a prespecified subgroup of 456 MVD patients were allocated by stratified randomization to treatment with BP-SES (n = 225) or PP-EES (n = 231). The previously reported primary endpoint of this study was freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization) at 9 months.
RESULTS


In this MVD substudy, baseline patient, lesion and procedure characteristics were similar between the treatment arms. At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p = .29 and 10.2 vs. 13.4%; p = .29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p = .33 and 0.9 vs. 1.7%; p = .43), respectively. Composite endpoint of cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations were also similar.
CONCLUSIONS


These results confirm good long-term safety and efficacy of the studied bioresorbable polymer stent in this high-risk patient population.",2020,"At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p = .29 and 10.2 vs. 13.4%; p = .29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p = .33 and 0.9 vs. 1.7%; p = .43), respectively.","['patients with multivessel coronary artery disease (MVD', '1,119 patients (intention-to-treat', 'multivessel coronary artery disease patients treated either with bioresoarbable polymer sirolimus-eluting stent or permanent polymer everolimus-eluting stent', '456 MVD patients']","['sirolimus-eluting stent with bioresorbable polymer (BP-SES; Ultimaster', 'BP-SES', 'coronary stenting', 'PP-EES']","['definite or probable stent thrombosis', 'cardiac death and MI, and patient-oriented composite endpoint of any death, MI, and coronary revascularizations', 'rates of TLF', 'freedom from target lesion failure (TLF: a composite of cardiac death, target vessel-related myocardial infarction [MI] and clinically-indicated target lesion revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}]","[{'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",1119.0,0.16002,"At 1 and 5 years, both BP-SES and PP-EES displayed low and comparable rates of TLF (5.3 vs. 7.8%; p = .29 and 10.2 vs. 13.4%; p = .29), and definite or probable stent thrombosis (0.4 vs. 1.3%; p = .33 and 0.9 vs. 1.7%; p = .43), respectively.","[{'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Iñiguez', 'Affiliation': 'Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chevalier', 'Affiliation': 'Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud, Massy, France.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': 'Department of Cardiology, Segeberger Kliniken, Bad Segeberg, Germany.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Neylon', 'Affiliation': 'SAOLTA Health Care Group, Galway University Hospital and NUI, Galway, Ireland.'}, {'ForeName': 'Victor A', 'Initials': 'VA', 'LastName': 'Jiménez', 'Affiliation': 'Cardiology Department, Hospital Alvaro Cunqueiro, University Hospital of Vigo, Vigo, Spain.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Kornowski', 'Affiliation': 'Cardiology Department, Rabin Medical Centre, Petah Tikva, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrie', 'Affiliation': 'Department of Cardiology, Rangueil University Hospital, Toulouse, France.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'Interventional Cardiology Department, La Paz University Hospital, Madrid, Spain.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': 'Cardiovascular Centre, Onze Lieve Vrouwe Ziekenhuis, Aalst, Belgium and Division of Cardiology, Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Serra-Peñaranda', 'Affiliation': 'Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIB-SantPau, CIBERCV, Universidad Autónoma de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Guiducci', 'Affiliation': 'Interventional Cardiology Unit, S. Maria Nuova Hospital, Reggio Emilia, Italy.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Valdés-Chávarri', 'Affiliation': 'Cardiology Department, Hospital Universitario Virgen de la Arrixaca, IMIB-Arrixaca, Murcia, Spain.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Yajima', 'Affiliation': 'Department of Cardiovascular Medicine, The Cardiovascular Institute, Tokyo, Japan.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': 'The Lambe Institute, NUI Galway, Ireland.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiology and Catheterization Laboratory, Shonan Kamakura General Hospital, Kamakura, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28224']
196,31053766,Androgen decline and survival during docetaxel therapy in metastatic castration resistant prostate cancer (mCRPC).,"BACKGROUND


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


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


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


Declines in testosterone during docetaxel treatment is associated with a longer survival, consistent with a favorable prognostic significance of higher serum androgens in the CRPC.",2020,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","['Data from 1050 men treated on CALGB 90401 with', 'metastatic castration resistant prostate cancer (mCRPC']","['Docetaxel', 'Androstenedione (A) and DHEA in docetaxel-treated mCRPC', 'docetaxel therapy', 'docetaxel, prednisone and either bevacizumab or placebo']","['testosterone levels', 'Median OS for low testosterone decline', 'serum androgen levels (Testosterone (T', 'overall survival (OS', 'hazard ratio for death', 'Androgen decline and survival', 'Changes in T, A and DHEA levels']","[{'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.188418,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","[{'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'University of Minnesota and Masonic Cancer Center, Minneapolis, MN, USA. ryanc@umn.edu.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York, NY, USA.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners Cancer Care, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0152-3']
197,31421635,Maintenance of antidepressant and antisuicidal effects by D-cycloserine among patients with treatment-resistant depression who responded to low-dose ketamine infusion: a double-blind randomized placebo-control study.,"Increasing evidence supports a rapid antidepressant and antisuicidal effect of a single subanesthetic dose of ketamine infusion for treatment-resistant depression (TRD). Maintaining the initial clinical response after ketamine infusion in TRD is a crucial next-step challenge. D-cycloserine (DCS), a partial agonist of the glycine co-agonist of the N-methyl-D-aspartate (NMDA) glutamate receptor, is potentially effective as a depression augmentation treatment. However, whether DCS maintains the antidepressant and antisuicidal effects of ketamine infusion remains unknown. In all, 32 patients with TRD (17 with major depression and 15 with bipolar depression) who responded to ketamine infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47 ± 4.11 at baseline were randomly divided to 6-week DCS treatment (250 mg for 2 days, 500 mg for 2 days, 750 mg for 3 days, and 1000 mg for 5 weeks) and placebo groups. Depression symptoms were rated at timepoints of dose titration and weekly. During the 6-week treatment, the total scores of HAMD did not differ between the DCS and placebo groups. The results remained consistent when stratified by disorder. A mixed model analysis indicated that the DCS group exhibited lower scores of HAMD item 3 (suicide) compared with the placebo group throughout the follow-up period (p = 0.01). A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group. DCS may be therapeutically beneficial for patients with TRD who responded to ketamine infusion but have a residual suicidal risk.",2019,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"['32 patients with TRD (17 with major depression and 15 with bipolar depression', 'infusion with an average 17-item Hamilton Depression Rating Scale (HAMD) score of 9.47\u2009±\u20094.11 at baseline', 'patients with treatment-resistant depression who responded to low-dose ketamine infusion', 'patients with TRD']","['DCS treatment', 'placebo', 'DCS', 'ketamine', 'D-cycloserine (DCS', 'D-cycloserine']","['total scores of HAMD', 'Depression symptoms', 'HAMD item 3 (suicide']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}]",,0.143272,A superior maintenance of the antisuicidal effect of ketamine was observed in the DCS group than in the placebo group.,"[{'ForeName': 'Mu-Hong', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Ming', 'Initials': 'CM', 'LastName': 'Cheng', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Wei-Chen', 'Initials': 'WC', 'LastName': 'Lin', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Ta', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chen-Jee', 'Initials': 'CJ', 'LastName': 'Hong', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Pei-Chi', 'Initials': 'PC', 'LastName': 'Tu', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Ya-Mei', 'Initials': 'YM', 'LastName': 'Bai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shih-Jen', 'Initials': 'SJ', 'LastName': 'Tsai', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA. john.krystal@yale.edu.'}, {'ForeName': 'Tung-Ping', 'Initials': 'TP', 'LastName': 'Su', 'Affiliation': 'Division of Psychiatry, Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan. tomsu0402@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0480-y']
198,31809413,Acute Apnea Does Not Improve 3-km Cycling Time Trial Performance.,"PURPOSE


Intense exercise evokes a spleen contraction releasing red blood cells into blood circulation. The same mechanism is found after acute apnea, increasing hemoglobin concentration ([Hb]) by 2% to 5%. The aim of this study was twofold: [1] to identify the optimal apnea modalities to acutely increase [Hb] and [2] use these modalities to examine whether prerace apnea can improve a 3-km time trial (TT).
METHODS


In part 1, 11 male subjects performed 12 different apnea protocols based on three modalities: mode, frequency, and intensity. Venous blood samples for [Hb] were collected before, immediately, and 5 min after each protocol. In part 2, 12 recreationally active subjects performed 3-km cycling TT in three different conditions: apnea, control, and placebo, after a 10-min warm-up. Power output, HR, and oxygen uptake (V˙O2) were continuously measured. Venous [Hb] was sampled at baseline, after warm-up, and before TT. Additionally, these subjects performed constant cycling at Δ25 (25% between gas exchange threshold and V˙O2 max) in two conditions (control and apnea) to determine V˙O2 kinetics.
RESULTS


Although including one single apnea in the warming up evoked a positive change in [Hb] pattern (P = 0.049) and one single apnea seemed to improve V˙O2 kinetics in constant submaximal cycling (τ: P = 0.060, mean response time: P = 0.064), performance during the 3-km TT did not differ between conditions (P = 0.840; apnea, 264.8 ± 14.1 s; control, 263.9 ± 12.9 s, placebo, 264.0 ± 15.8 s). Average normalized power output (P = 0.584) and V˙O2, HR, and lactate did not differ either (P > 0.05).
CONCLUSIONS


These results suggest that potential effects of apnea, that is, speeding of V˙O2 kinetics through a transient increase in [Hb], are overruled by a warming-up protocol.",2020,"Average normalized power output (P = 0.584) and V˙O2, HR, and lactate did not differ either (P > 0.05).
","['11 male subjects performed 12 different apnea protocols based on three modalities: mode, frequency, and intensity']",['placebo'],"['V˙O2, HR, and lactate', 'hemoglobin concentration ([Hb', 'Average normalized power output', 'V˙O2 kinetics', 'Acute Apnea', 'Power output, HR, and oxygen uptake (V˙O2']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",11.0,0.0185869,"Average normalized power output (P = 0.584) and V˙O2, HR, and lactate did not differ either (P > 0.05).
","[{'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Bouten', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, BELGIUM.'}, {'ForeName': 'Alessandro L', 'Initials': 'AL', 'LastName': 'Colosio', 'Affiliation': 'Department of Neurological and Movement Sciences, University of Verona, ITALY.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Bourgois', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, BELGIUM.'}, {'ForeName': 'Leen', 'Initials': 'L', 'LastName': 'Lootens', 'Affiliation': 'Doping Control Laboratory, Department of Diagnostic Sciences, Ghent University, Ghent, BELGIUM.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'VAN Eenoo', 'Affiliation': 'Doping Control Laboratory, Department of Diagnostic Sciences, Ghent University, Ghent, BELGIUM.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Bourgois', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, BELGIUM.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Boone', 'Affiliation': 'Department of Movement and Sports Sciences, Ghent University, Ghent, BELGIUM.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002236']
199,31973598,Healthy Hearts via Live Videoconferencing: An Exercise and Diet Intervention in Pediatric Heart Transplant Recipients.,"Background Pediatric heart transplant recipients have high-risk cardiovascular profiles that can affect their long-term outcomes; however, promoting exercise and healthy diet has not been a major focus in the field. The objective of this study was to test the feasibility and impact of a supervised exercise and diet intervention delivered via live videoconferencing in this population. Methods and Results Patients 8 to 19 years of age at least 1 year post heart transplantation were enrolled. The 12- to 16-week intervention phase included live video-supervised exercise (×3/week) and nutrition (×1/week) sessions. The 12- to 16-week maintenance phase included ×1/week live video-supervised exercise and nutrition sessions and ×2/week self-directed exercise sessions. Cardiac, vascular, nutritional, and functional health indices were obtained at baseline, after intervention, and after maintenance. Fourteen patients (median age, 15.2; interquartile range, 14.3-16.7 years) at a median of 3.3 (interquartile range, 1.5-9.7) years after heart transplant completed the intervention. Patients attended 89.6±11% of exercise and 88.4±10% of nutrition sessions during the intervention and 93.4±11% of exercise and 92.3±11% of nutrition sessions during maintenance. After intervention, body mass index percentile (median, -27%;  P =0.02), endothelial function (median, +0.29;  P =0.04), maximum oxygen consumption (median, +2 mL/kg per minute;  P =0.002). Functional Movement Screening total score (median, +2.5;  P =0.002) and daily consumption of saturated fat (median, -6 g;  P =0.02) improved significantly. After maintenance, improvements in maximum oxygen consumption (median, +3.2 mL/kg per minute;  P =0.02) and Functional Movement Screening total score (median, +5;  P =0.002) were sustained. Conclusions In pediatric heart transplant recipients, a live video-supervised exercise and diet intervention is feasible. Our results demonstrate excellent adherence with significant improvements in cardiovascular and functional health. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02519946.",2020,"Functional Movement Screening total score (median, +2.5;  P =0.002) and daily consumption of saturated fat (median, -6 g;  P =0.02) improved significantly.","['Pediatric Heart Transplant Recipients', 'Healthy Hearts via Live Videoconferencing', 'pediatric heart transplant recipients', ' Pediatric heart transplant recipients', 'Patients 8 to 19\xa0years of age at least 1\xa0year post heart transplantation were enrolled', 'Fourteen patients (median age, 15.2; interquartile range, 14.3-16.7\xa0years) at a median of 3.3 (interquartile range, 1.5-9.7) years after heart transplant completed the intervention']","['supervised exercise and diet intervention delivered via live videoconferencing', 'live video-supervised exercise and diet intervention', '×1/week live video-supervised exercise and nutrition sessions and ×2/week self-directed exercise sessions', 'live video-supervised exercise (×3/week) and nutrition (×1/week) sessions', 'Exercise and Diet Intervention']","['body mass index percentile', 'maximum oxygen consumption', 'daily consumption of saturated fat', 'cardiovascular and functional health', 'Cardiac, vascular, nutritional, and functional health indices', 'Functional Movement Screening total score', 'endothelial function']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517590', 'cui_str': 'Sixteen point seven'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.10077,"Functional Movement Screening total score (median, +2.5;  P =0.002) and daily consumption of saturated fat (median, -6 g;  P =0.02) improved significantly.","[{'ForeName': 'Angela C', 'Initials': 'AC', 'LastName': 'Chen', 'Affiliation': 'Division of Pediatric Cardiology Department of Pediatrics Stanford University Medical Center Palo Alto CA.'}, {'ForeName': 'Faustine D', 'Initials': 'FD', 'LastName': 'Ramirez', 'Affiliation': 'University of California, San Francisco San Francisco CA.'}, {'ForeName': 'David N', 'Initials': 'DN', 'LastName': 'Rosenthal', 'Affiliation': 'Division of Pediatric Cardiology Department of Pediatrics Stanford University Medical Center Palo Alto CA.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Couch', 'Affiliation': 'Department of Rehabilitation, Exercise and Nutrition Sciences University of Cincinnati Medical Center Cincinnati OH.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Berry', 'Affiliation': 'American Council on Exercise San Diego CA.'}, {'ForeName': 'Katie J', 'Initials': 'KJ', 'LastName': 'Stauffer', 'Affiliation': 'Division of Pediatric Cardiology Department of Pediatrics Stanford University Medical Center Palo Alto CA.'}, {'ForeName': 'Jerrid', 'Initials': 'J', 'LastName': 'Brabender', 'Affiliation': 'Division of Pediatric Cardiology Department of Pediatrics Stanford University Medical Center Palo Alto CA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'McDonald', 'Affiliation': 'Division of Pediatric Cardiology Department of Pediatrics Stanford University Medical Center Palo Alto CA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Division of Pediatric Cardiology Department of Pediatrics Stanford University Medical Center Palo Alto CA.'}, {'ForeName': 'Lynsey', 'Initials': 'L', 'LastName': 'Barkoff', 'Affiliation': 'Division of Pediatric Cardiology Department of Pediatrics Stanford University Medical Center Palo Alto CA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Nourse', 'Affiliation': 'Division of Pediatric Cardiology Department of Pediatrics Stanford University Medical Center Palo Alto CA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kazmucha', 'Affiliation': 'Division of Pediatric Cardiology Department of Pediatrics Stanford University Medical Center Palo Alto CA.'}, {'ForeName': 'C Jason', 'Initials': 'CJ', 'LastName': 'Wang', 'Affiliation': 'Division of General Pediatrics, and Center for Policy, Outcomes and Prevention Stanford University Palo Alto CA.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Olson', 'Affiliation': 'Division of Pediatric Cardiology Department of Pediatrics Stanford University Medical Center Palo Alto CA.'}, {'ForeName': 'Elif Seda', 'Initials': 'ES', 'LastName': 'Selamet Tierney', 'Affiliation': 'Division of Pediatric Cardiology Department of Pediatrics Stanford University Medical Center Palo Alto CA.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.013816']
200,31973599,Cluster-Randomized Trial of Thrombolysis Implementation Support in Metropolitan and Regional Australian Stroke Centers: Lessons for Individual and Systems Behavior Change.,"Background Intravenous thrombolytic therapy (IVT) with tissue plasminogen activator for acute ischemic stroke is underutilized in many parts of the world. Randomized trials to test the effectiveness of thrombolysis implementation strategies are limited. Methods and Results This study aimed to test the effectiveness of a multicomponent, multidisciplinary tissue plasminogen activator implementation package in increasing the proportion of thrombolyzed cases while maintaining accepted benchmarks for low rates of intracranial hemorrhage and high rates of functional outcomes at 3 months. A cluster randomized controlled trial of 20 hospitals in the early stages of thrombolysis implementation across 3 Australian states was undertaken. Monitoring of IVT rates during the baseline period allowed hospitals (the unit of randomization) to be grouped into 3 baseline IVT strata-very low rates (0% to ≤4.0%); low rates (>4.0% to ≤10.0%); and moderate rates (>10.0%). Hospitals were randomized to an implementation package (experimental group) or usual care (control group) using a 1:1 ratio. The 16-month intervention was based on behavioral theory and analysis of the steps, roles, and barriers to rapid assessment for thrombolysis eligibility and involved comprehensive strategies addressing individual and system-level change. The primary outcome was the difference in tissue plasminogen activator proportions between the 2 groups postintervention. The absolute difference in postintervention IVT rates between intervention and control hospitals adjusted for baseline IVT rate and stratum was not significant (primary outcome rate difference=1.1% (95% CI -1.5% to 3.7%;  P =0.38). Rates of intracranial hemorrhage remained below international benchmarks. Conclusions The implementation package resulted in no significant change in tissue plasminogen activator implementation, suggesting that ongoing support is needed to sustain initial modifications in behavior. Clinical Trial Registration URL: www.anzctr.org.au Unique identifiers: ACTRN12613000939796 and U1111-1145-6762.",2020,"The implementation package resulted in no significant change in tissue plasminogen activator implementation, suggesting that ongoing support is needed to sustain initial modifications in behavior.","['Metropolitan and Regional Australian Stroke Centers', '20 hospitals in the early stages of thrombolysis implementation across 3 Australian states was undertaken']","['implementation package (experimental group) or usual care (control group', 'multicomponent, multidisciplinary tissue plasminogen activator implementation package', ' Intravenous thrombolytic therapy (IVT) with tissue plasminogen activator']","['IVT rates', 'postintervention IVT rates', 'Rates of intracranial hemorrhage', 'tissue plasminogen activator implementation', 'moderate rates', 'tissue plasminogen activator proportions']","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}]","[{'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0040044', 'cui_str': 'Thrombolysis, Therapeutic'}]","[{'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]",,0.194864,"The implementation package resulted in no significant change in tissue plasminogen activator implementation, suggesting that ongoing support is needed to sustain initial modifications in behavior.","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'The University of Newcastle, School of Medicine and Public Health Callaghan Australia.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Attia', 'Affiliation': 'The University of Newcastle, School of Medicine and Public Health Callaghan Australia.'}, {'ForeName': 'Cate', 'Initials': 'C', 'LastName': ""D'Este"", 'Affiliation': 'The University of Newcastle, School of Medicine and Public Health Callaghan Australia.'}, {'ForeName': 'Annika E', 'Initials': 'AE', 'LastName': 'Ryan', 'Affiliation': 'The University of Newcastle, School of Medicine and Public Health Callaghan Australia.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Henskens', 'Affiliation': 'The University of Newcastle, School of Medicine and Public Health Callaghan Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Kerr', 'Affiliation': 'Hunter New England Health New Lambton Heights Australia.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Hunter New England Health New Lambton Heights Australia.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Sanson-Fisher', 'Affiliation': 'The University of Newcastle, School of Medicine and Public Health Callaghan Australia.'}, {'ForeName': 'Christopher F', 'Initials': 'CF', 'LastName': 'Bladin', 'Affiliation': 'Eastern Health Monash University Box\xa0Hill Australia.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Lindley', 'Affiliation': 'The George Institute for Global Health Sydney Australia.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Middleton', 'Affiliation': ""Nursing Research Institute Australian Catholic University and St Vincent's Health Australia Sydney and Darlinghurst Australia.""}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'The University of Newcastle, School of Medicine and Public Health Callaghan Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.119.012732']
201,32234355,Patient Education and Engagement Through Multimedia: A Prospective Pilot Study on Health Literacy in Patients with Cerebral Aneurysms.,"BACKGROUND


Improving the comprehension and communication of patient education materials could augment patient participation in shared clinical decision making. Inadequate healthcare-oriented educational resources for patients with a newly diagnosed complex disease, such as a cerebral aneurysm, can lead to an insufficient understanding of their ailment. As such, we hypothesized that a PowerPoint-style educational intervention with grade-conscious (i.e., sixth grade level) written material accompanied by visual graphics would help improve patient health literacy and satisfaction.
METHODS


A randomized prospective pilot study was conducted during a 1-year period in 2018. Preclinic encounter knowledge assessment surveys were administered to 52 patients with brain aneurysms (newly diagnosed or during follow-up) presenting for their neurosurgery outpatient clinic visit. The patients were assigned to 1 of 2 cohorts, with 26 each in the educational intervention group and control group, using a quasi-randomization method of alternating the assigned group for each successive patient. At the conclusion of their clinic encounter, all the patients completed a postclinic encounter knowledge assessment and satisfaction survey. Differences in covariates such as gender distribution, age, and family history of aneurysms were analyzed between the control and intervention groups.
RESULTS


The overall study cohort had a high baseline knowledge about cerebral aneurysms with an average preclinic encounter score of 5.37 on the 7-question survey. The educational intervention resulted in an upward trend in the patient knowledge scores. No statistically significant difference was detected in the patient satisfaction scores between the intervention and control groups. However, most of the patients receiving the educational intervention reported that the educational material was easy to understand (95.7%), helpful (86.9%), and relevant (87%) to their clinic visit.
CONCLUSION


Overall, in the present prospective study, the use of a multimedia-based educational intervention resulted in an upward trend in knowledge without a statistically significant difference in patient satisfaction scores compared with the control patients. To better measure the effectiveness of multimedia-based patient education interventions, future studies should account for the patients' baseline education level, preexisting educational resources available to study patients, socioeconomic factors, and emotional state.",2020,No statistical difference was detected in patient satisfaction scores between the intervention and control groups.,"['one-year period in 2018', 'Patients with Cerebral Aneurysms', '52 brain aneurysm patients (newly diagnosed or follow-up) presenting for their neurosurgery outpatient clinic visit', 'patients with a newly diagnosed complex disease']","['multimedia educational intervention', 'Health Literacy', 'educational intervention', 'multimedia-based patient education interventions']","['patient knowledge scores', 'patient health literacy and satisfaction', 'knowledge gain', 'patient satisfaction scores']","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155730', 'cui_str': 'Cerebral aneurysm, nonruptured'}, {'cui': 'C0751003', 'cui_str': 'Brain Aneurysm'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",26.0,0.0575532,No statistical difference was detected in patient satisfaction scores between the intervention and control groups.,"[{'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA. Electronic address: agarwaln@upmc.edu.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Funahashi', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Tavis', 'Initials': 'T', 'LastName': 'Taylor', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Jorge', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Rafey', 'Initials': 'R', 'LastName': 'Feroze', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Hansberry', 'Affiliation': 'Department of Radiology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Gross', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Jankowitz', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Friedlander', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh, USA.'}]",World neurosurgery,['10.1016/j.wneu.2020.03.099']
202,31279324,Effects of hydrocortisone on autobiographical memory retrieval in patients with posttraumatic stress disorder and borderline personality disorder: the role of childhood trauma.,"In a previous study, we found that patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD) showed better autobiographical memory (AM) retrieval after hydrocortisone administration than after placebo administration. Here we investigate the neural correlates of AM retrieval after hydrocortisone administration in patients with PTSD or BPD. We recruited 78 female participants for this placebo-controlled crossover study: 40 healthy controls, 20 patients with PTSD, and 18 patients with BPD (all without medication). All participants received an oral placebo or 10 mg hydrocortisone in a randomized order before performing an AM task. Neural activity was monitored during the task by functional magnetic resonance imaging. Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake. Multiple regression analysis revealed that Childhood Trauma Questionnaire scores correlated positively with hydrocortisone effects on activation in the anterior medial prefrontal cortex (amPFC), ventrolateral prefrontal cortex (vlPFC), posterior cingulate cortex (PCC), angular gyrus, and cerebellum. These results suggest that hydrocortisone-induced neural activation pattern during AM retrieval is related to childhood trauma. Previously described effects in the hippocampus, which were absent in the current study, might be related to PTSD caused by trauma in adulthood. The effects of hydrocortisone on brain activation and how these effects are influenced by childhood trauma, trauma in adulthood, and PTSD symptoms should be determined in future studies.",2019,"Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake.","['patients with PTSD or BPD', 'patients with posttraumatic stress disorder (PTSD) and borderline personality disorder (BPD', '78 female participants for this placebo-controlled crossover study: 40 healthy controls, 20 patients with PTSD, and 18 patients with BPD (all without medication', 'patients with posttraumatic stress disorder and borderline personality disorder']","['oral placebo', 'hydrocortisone']","['Neural activation', 'autobiographical memory retrieval', 'Childhood Trauma Questionnaire scores', 'autobiographical memory (AM) retrieval', 'anterior medial prefrontal cortex (amPFC), ventrolateral prefrontal cortex (vlPFC), posterior cingulate cortex (PCC), angular gyrus, and cerebellum', 'brain activation', 'Neural activity', 'neural activation pattern']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]","[{'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0152305', 'cui_str': 'Prelunate Gyrus'}, {'cui': 'C0007765', 'cui_str': 'Parencephalon'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",78.0,0.0472001,"Neural activation did not differ between the three groups during AM retrieval, neither in the placebo condition nor after hydrocortisone intake.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany. sophie.metz@charite.de.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Fleischer', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Gärnter', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Golde', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Campus Benjamin Franklin, Hindenburgdamm 30, Berlin, 12203, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0459-8']
203,32200138,Osimertinib in T790M-positive and -negative patients with EGFR-mutated advanced non-small cell lung cancer (the TREM-study).,"OBJECTIVES


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


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


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


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


This trial is registered with ClinicalTrials.gov (NCT02504346).",2020,"Median overall survival (OS) was 17.9 months (95 % CI, 14.4-21.3).","['Of 199 included patients, 120 (60 %) were T790M-positive, 52 (26 %) were T790M-negative and 27 (14 %) had unknown T790M-status', 'Patients with progression on at least one previous EGFR-TKI', 'T790M-positive patients', 'non-small cell lung cancer patients with acquired resistance to first- or second-generation EGFR-TKIs, osimertinib is approved in the presence of the T790 M resistance mutation', 'Patients were included regardless of the presence of T790 M', 'T790M-positive and -negative patients with EGFR-mutated advanced non-small cell lung cancer (the TREM-study', 'T790M-positive and T790M-negative patients']",[],"['Duration of response', 'Median overall survival (OS', 'objective response rate (ORR', 'ORR', 'Overall ORR', 'ECOG performance status', 'brain metastases', 'Overall median progression-free survival (PFS']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0205540', 'cui_str': 'Approved (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",199.0,0.302362,"Median overall survival (OS) was 17.9 months (95 % CI, 14.4-21.3).","[{'ForeName': 'Inger Johanne Zwicky', 'Initials': 'IJZ', 'LastName': 'Eide', 'Affiliation': 'Vestre Viken Hospital Trust, Drammen, Norway; Department of Cancer Genetics, Institute for Cancer Research, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway. Electronic address: ingei@vestreviken.no.'}, {'ForeName': 'Åslaug', 'Initials': 'Å', 'LastName': 'Helland', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway; Departement of Oncology, Oslo University Hospital, Oslo, Norway; University of Oslo, Department of Clinical Medicine, Oslo, Norway.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ekman', 'Affiliation': 'Thoracic Oncology Center, Karolinska University Hospital/Departement of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Mellemgaard', 'Affiliation': 'Herlev Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Karin Holmskov', 'Initials': 'KH', 'LastName': 'Hansen', 'Affiliation': 'Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Saulius', 'Initials': 'S', 'LastName': 'Cicenas', 'Affiliation': 'National Cancer Institute, VU MF, Vilnius, Lithuania.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Koivunen', 'Affiliation': 'Oulu University Hospital, University of Oulu, MRC Oulu, Oulu, Finland.'}, {'ForeName': 'Bjørn Henning', 'Initials': 'BH', 'LastName': 'Grønberg', 'Affiliation': ""Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology, Trondheim, Norway; Department of Oncology, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}, {'ForeName': 'Odd Terje', 'Initials': 'OT', 'LastName': 'Brustugun', 'Affiliation': 'Vestre Viken Hospital Trust, Drammen, Norway; Department of Cancer Genetics, Institute for Cancer Research, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.03.009']
204,31986989,Effects of Intracoronary Alteplase on Microvascular Function in Acute Myocardial Infarction.,"Background Impaired microcirculatory reperfusion worsens prognosis following acute ST-segment-elevation myocardial infarction. In the T-TIME (A Trial of Low-Dose Adjunctive Alteplase During Primary PCI) trial, microvascular obstruction on cardiovascular magnetic resonance imaging did not differ with adjunctive, low-dose, intracoronary alteplase (10 or 20 mg) versus placebo during primary percutaneous coronary intervention. We evaluated the effects of intracoronary alteplase, during primary percutaneous coronary intervention, on the index of microcirculatory resistance, coronary flow reserve, and resistive reserve ratio. Methods and Results A prespecified physiology substudy of the T-TIME trial. From 2016 to 2017, patients with ST-segment-elevation myocardial infarction ≤6 hours from symptom onset were randomized in a double-blind study to receive alteplase 20 mg, alteplase 10 mg, or placebo infused into the culprit artery postreperfusion, but prestenting. Index of microcirculatory resistance, coronary flow reserve, and resistive reserve ratio were measured after percutaneous coronary intervention. Cardiovascular magnetic resonance was performed at 2 to 7 days and 3 months. Analyses in relation to ischemic time (<2, 2-4, and ≥4 hours) were prespecified. One hundred forty-four patients (mean age, 59±11 years; 80% male) were prospectively enrolled, representing 33% of the overall population (n=440). Overall, index of microcirculatory resistance (median, 29.5; interquartile range, 17.0-55.0), coronary flow reserve(1.4 [1.1-2.0]), and resistive reserve ratio (1.7 [1.3-2.3]) at the end of percutaneous coronary intervention did not differ between treatment groups. Interactions were observed between ischemic time and alteplase for coronary flow reserve ( P =0.013), resistive reserve ratio ( P =0.026), and microvascular obstruction ( P =0.022), but not index of microcirculatory resistance. Conclusions In ST-segment-elevation myocardial infarction with ischemic time ≤6 hours, there was overall no difference in microvascular function with alteplase versus placebo. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT02257294.",2020,"Interactions were observed between ischemic time and alteplase for coronary flow reserve ( P =0.013), resistive reserve ratio ( P =0.026), and microvascular obstruction ( P =0.022), but not index of microcirculatory resistance.","['From 2016 to 2017, patients with ST-segment-elevation myocardial infarction ≤6\xa0hours from symptom onset', 'One hundred forty-four patients (mean age, 59±11\xa0years; 80% male) were prospectively enrolled, representing 33% of the overall population (n=440', 'Acute Myocardial Infarction', 'acute ST-segment-elevation myocardial infarction', 'primary percutaneous coronary intervention']","['Intracoronary Alteplase', 'placebo', 'intracoronary alteplase', 'alteplase 20\xa0mg, alteplase 10\xa0mg, or placebo']","['Microvascular Function', 'microcirculatory resistance', 'index of microcirculatory resistance, coronary flow reserve, and resistive reserve ratio', 'resistive reserve ratio', 'microvascular function', 'Overall, index of microcirculatory resistance', 'microvascular obstruction', 'ischemic time and alteplase for coronary flow reserve', 'Index of microcirculatory resistance, coronary flow reserve, and resistive reserve ratio', 'Cardiovascular magnetic resonance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}]",,0.250892,"Interactions were observed between ischemic time and alteplase for coronary flow reserve ( P =0.013), resistive reserve ratio ( P =0.026), and microvascular obstruction ( P =0.022), but not index of microcirculatory resistance.","[{'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Maznyczka', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow Glasgow United Kingdom.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'McCartney', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow Glasgow United Kingdom.'}, {'ForeName': 'Keith G', 'Initials': 'KG', 'LastName': 'Oldroyd', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow Glasgow United Kingdom.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Lindsay', 'Affiliation': 'West of Scotland Heart and Lung Centre Golden Jubilee National Hospital, Clydebank Glasgow United Kingdom.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McEntegart', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow Glasgow United Kingdom.'}, {'ForeName': 'Hany', 'Initials': 'H', 'LastName': 'Eteiba', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow Glasgow United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rocchiccioli', 'Affiliation': 'West of Scotland Heart and Lung Centre Golden Jubilee National Hospital, Clydebank Glasgow United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Good', 'Affiliation': 'West of Scotland Heart and Lung Centre Golden Jubilee National Hospital, Clydebank Glasgow United Kingdom.'}, {'ForeName': 'Aadil', 'Initials': 'A', 'LastName': 'Shaukat', 'Affiliation': 'West of Scotland Heart and Lung Centre Golden Jubilee National Hospital, Clydebank Glasgow United Kingdom.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Robertson', 'Affiliation': 'West of Scotland Heart and Lung Centre Golden Jubilee National Hospital, Clydebank Glasgow United Kingdom.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Kodoth', 'Affiliation': 'Leeds University and Leeds Teaching Hospitals NHS Trust Leeds United Kingdom.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Greenwood', 'Affiliation': 'Leeds University and Leeds Teaching Hospitals NHS Trust Leeds United Kingdom.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Cotton', 'Affiliation': 'Wolverhampton University Hospital NHS Trust Wolverhampton United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Hood', 'Affiliation': 'West of Scotland Heart and Lung Centre Golden Jubilee National Hospital, Clydebank Glasgow United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Watkins', 'Affiliation': 'West of Scotland Heart and Lung Centre Golden Jubilee National Hospital, Clydebank Glasgow United Kingdom.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Macfarlane', 'Affiliation': 'Electrocardiology Group Royal Infirmary Glasgow United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kennedy', 'Affiliation': 'Electrocardiology Group Royal Infirmary Glasgow United Kingdom.'}, {'ForeName': 'R Campbell', 'Initials': 'RC', 'LastName': 'Tait', 'Affiliation': 'Department of Haematology Royal Infirmary Glasgow United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Welsh', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow Glasgow United Kingdom.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow Glasgow United Kingdom.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Collison', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow Glasgow United Kingdom.'}, {'ForeName': 'Lynsey', 'Initials': 'L', 'LastName': 'Gillespie', 'Affiliation': 'Project Management Unit Greater Glasgow and Clyde Health Board Glasgow United Kingdom.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'McConnachie', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow Glasgow United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow Glasgow United Kingdom.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014066']
205,31486777,Magnetic seizure therapy (MST) for major depressive disorder.,"Electroconvulsive therapy (ECT) is effective for major depressive disorder (MDD) but its effects on memory limit its widespread use. Magnetic seizure therapy (MST) is a potential alternative to ECT that may not adversely affect memory. In the current trial, consecutive patients with MDD consented to receive MST applied over the prefrontal cortex according to an open-label protocol. Depressive symptoms and cognition were assessed prior to, during and at the end of treatment. Patients were treated two to three times per week with high-frequency MST (i.e., 100 Hz) (N = 24), medium frequency MST (i.e., 60 or 50 Hz) (N = 26), or low-frequency MST (i.e., 25 Hz MST) (N = 36) using 100% stimulator output. One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n = 17) or received a maximum of 24 sessions (n = 30). High-frequency (100 Hz) MST produced the highest remission rate (33.3%). Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance. Under open conditions, MST led to clinically meaningful reduction in depressive symptoms in patients with MDD and produced minimal cognitive impairment. Future studies should compare MST and ECT under double-blind randomized condition.",2020,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","['consecutive patients with MDD consented to receive', 'major depressive disorder', 'One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n\u2009=\u200917) or received a maximum of 24 sessions (n\u2009=\u200930']","['Magnetic seizure therapy (MST', 'Electroconvulsive therapy (ECT', 'MST']","['depressive symptoms', 'High-frequency', 'Depressive symptoms and cognition', 'minimal cognitive impairment', 'highest remission rate', 'brief visuospatial memory task performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1291708', 'cui_str': 'Minimal cognitive impairment'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",140.0,0.0334955,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","[{'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dimitrova', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClintock', 'Affiliation': 'Neurocognitive Research Laboratory, Department of Psychiatry, University of Texas Southwestern Medical Center, and Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yinming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Voineskos', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Goldbloom', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Albert H C', 'Initials': 'AHC', 'LastName': 'Wong', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Knyahnytska', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Toronto General Hospital, University Health Network, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Commercial Rd Melbourne, VIC, Australia.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0515-4']
206,31703023,Resistance Exercise-induced Regulation of Muscle Protein Synthesis to Intraset Rest.,"During a traditional set configuration of resistance exercise (TRD), characterized by a continuous completion of repetitions, a decrease in power output tends to occur throughout a set of repetitions. Inclusion of intraset rest, otherwise known as a cluster set configuration (CLU), counteracts this power decline. However, the effect of a CLU configuration on postexercise myofibrillar protein synthesis rates (MPS) and anabolic signaling has not been investigated.
PURPOSE


We aimed to determine if any mechanistic differences exist between TRD and CLU signaling events associated with muscle anabolism.
METHODS


In randomized crossover trials, eight resistance-trained participants (23 ± 1 yr, 81 ± 4.7 kg, body fat: 18% ± 1.9%; 1 repetition maximum [1RM], 150 ± 9.1 kg) performed an acute bout of CLU (4 sets × (2 × 5) repetitions, 30-s intraset rest, 90-s interset rest) and TRD (4 sets × 10 repetitions, 120-s interset rest) barbell back squats at approximately 70% 1RM with total volume load equated during primed continuous L-[ring-C6]phenylalanine infusions. Blood and muscle biopsy samples were collected at rest and after exercise at 0, 2, and 5 h.
RESULTS


There was no difference in postexercise MPS between the CLU and TRD condition (P > 0.05) and no changes in phosphorylation of mTORC1 downstream targets (p70S6K and 4EBP1). Total and phosphorylated yes-associated protein on Ser127 transiently increased (P < 0.01) immediately after exercise (t = 0) in CLU (~2.1-fold) and TRD condition (~2.2-fold).
CONCLUSIONS


Our results show that CLU is a viable anabolic option by preserving power output with similar MPS stimulation when compared with the TRD condition in trained young adults.",2020,"Total and phosphorylated YAP on Ser127 transiently increased (P<0.01) immediately after exercise (t=0) in CLU (~2.1 fold) and TRD condition (~2.2 fold).
","['eight resistance-trained participants (23±1 years, 81±4.7 kg, body fat: 18±1.9 %; 1 repetition maximum (1RM): 150±9.1 kg) performed an', 'trained young adults']","['CLU', 'resistance exercise (TRD', 'acute bout of CLU']","['Blood and muscle biopsy samples', 'Total and phosphorylated YAP on Ser127', 'phosphorylation of mTORC1 downstream targets (p70S6K and 4EBP1', 'post-exercise MPS']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0005768'}, {'cui': 'C0587033', 'cui_str': 'Muscle biopsy sample (specimen)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C3888046', 'cui_str': 'mTORC1 Complex'}, {'cui': 'C0522506', 'cui_str': 'Downstream (qualifier value)'}, {'cui': 'C1136240', 'cui_str': 'Ribosomal Protein S6 Kinases, 70-kDa'}, {'cui': 'C1979962', 'cui_str': 'After exercise (qualifier value)'}]",,0.0626006,"Total and phosphorylated YAP on Ser127 transiently increased (P<0.01) immediately after exercise (t=0) in CLU (~2.1 fold) and TRD condition (~2.2 fold).
","[{'ForeName': 'Amadeo F', 'Initials': 'AF', 'LastName': 'Salvador', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Askow', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL.'}, {'ForeName': 'Colleen F', 'Initials': 'CF', 'LastName': 'McKenna', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois at Urbana-Champaign, Urbana, IL.'}, {'ForeName': 'Hsin-Yu', 'Initials': 'HY', 'LastName': 'Fang', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Burke', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL.'}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Roy J. Carver Biotechnology Center, University of Illinois at Urbana-Champaign, Urbana, IL.'}, {'ForeName': 'Alexander V', 'Initials': 'AV', 'LastName': 'Ulanov', 'Affiliation': 'Roy J. Carver Biotechnology Center, University of Illinois at Urbana-Champaign, Urbana, IL.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Paluska', 'Affiliation': 'Department of Family Medicine, University of Illinois at Urbana-Champaign, Urbana, IL.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Petruzzello', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL.'}, {'ForeName': 'Marni D', 'Initials': 'MD', 'LastName': 'Boppart', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Oliver', 'Affiliation': 'Army West Point Athletics Association, West Point, NY.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Burd', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, Urbana, IL.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002213']
207,32234584,Stigma interdependence among pregnant HIV-infected couples in a cluster randomized controlled trial from rural South Africa.,"BACKGROUND


Stigma can exacerbate negative health outcomes in people living with HIV (PLWH). This longitudinal, cluster randomized controlled trial in rural Mpumalanga, South Africa, examined the interdependence of HIV-related stigma among pregnant couples living with HIV, and the potential impact of a lay health worker delivered intervention, Protect Your Family, on changes in stigma over time across couples, controlling for physical intimate partner violence (IPV), verbal IPV, gender, HIV knowledge, and months since HIV diagnosis. Using a form of the Actor-Partner Interdependence model, changes in stigma over time were also examined within each dyad of seroconcordant participants with HIV.
METHOD


Antenatal clinics were randomized to experimental or control conditions, and participants completed baseline antenatal and 12-month postpartum assessments. Both women and male partners participated in intervention sessions in gender concordant groups and couple or individual sessions.
RESULTS


Multilevel models (N = 1475) revealed stigma was related to condition and verbal intimate partner violence, but not time. Using an Actor-Partner Interdependence cross-lagged path model to examine within dyad changes in stigma for seroconcordant couples (n = 201), intervention condition participants' stigma levels were not interdependent over time. Women's 12-month stigma was related to their partners' stigma at baseline in the control condition, but not in the intervention condition.
DISCUSSION


Compared to women in the control condition, postpartum stigma among women in the intervention condition was not related to their male partners' stigma, suggesting that women's perception of stigma became uncoupled from that of their partners. The intervention may have promoted female empowerment to shape their own beliefs and attitudes towards what it means to be infected with HIV, and express their own agency in responding to how others treat them and they treat themselves.",2020,"Compared to women in the control condition, postpartum stigma among women in the intervention condition was not related to their male partners' stigma, suggesting that women's perception of stigma became uncoupled from that of their partners.","['rural Mpumalanga, South Africa', 'Both women and male partners', 'people living with HIV (PLWH', 'Antenatal clinics', 'pregnant couples living with HIV', 'pregnant HIV-infected couples in a cluster randomized controlled trial from rural South Africa']",[],"['stigma was related to condition and verbal intimate partner violence', 'Stigma interdependence', 'postpartum stigma']","[{'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",,0.0392253,"Compared to women in the control condition, postpartum stigma among women in the intervention condition was not related to their male partners' stigma, suggesting that women's perception of stigma became uncoupled from that of their partners.","[{'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Abbamonte', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ramlagan', 'Affiliation': 'HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research Council, Pretoria, South Africa.'}, {'ForeName': 'T K', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Cristofari', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Peltzer', 'Affiliation': 'HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research Council, Pretoria, South Africa; Department of Research & Innovation, University of Limpopo, Sovenga, South Africa.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sifunda', 'Affiliation': 'HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research Council, Pretoria, South Africa.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA. Electronic address: djones@med.miami.edu.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.112940']
208,31876670,Exercise Effects on Multiple Sclerosis Quality of Life and Clinical-Motor Symptoms.,"INTRODUCTION


Different therapies can improve clinical and motor symptoms of multiple sclerosis (MS) similarly, but studies comparing the effects of different exercise therapies on clinical and motor outcomes are scant. We compared the effects of exergaming (EXE), balance (BAL), cycling (CYC), proprioceptive neuromuscular facilitation (PNF), and a standard care wait-listed control group (CON) on clinical and motor symptoms and quality of life (QoL) in people with MS (PwMS).
METHODS


PwMS (n = 68, 90% female; age, 47.0 yr; Expanded Disability Status Scale score 5-6) were randomized into five groups. Before and after the interventions (five times a week for 5 wk), PwMS were tested for MS-related clinical and motor symptoms (Multiple Sclerosis Impact Scale-29 (MSIS-29), primary outcome), QoL (EuroQol Five Dimensions Questionnaire), symptoms of depression, gait and balance ability (Tinetti Assessment Tool), static and dynamic balance and fall risk (Berg Balance Scale), walking capacity (6-min walk test), and standing posturography on a force platform.
RESULTS


EXE, BAL, and CYC improved the MSIS-29 scores similarly. EXE and CYC improved QoL and walking capacity similarly but more than BAL. Only EXE improved gait and balance scores (Tinetti Assessment Tool). EXE and BAL improved fall risk and standing balance similarly but more than CYC. PNF and CON revealed no changes. The EuroQol Five Dimensions Questionnaire moderated the exercise effects on the MSIS-29 scores only in EXE. Changes in QoL and changes in the MSIS-29 scores correlated (R = 0.73) only in EXE.
CONCLUSION


In conclusion, BAL and CYC but EXE in particular, but not PNF, can improve clinical and motor symptoms and QoL in PwMS (Expanded Disability Status Scale score 5 to 6), expanding the evidence-based exercise options to reduce mobility limitations in PwMS.",2020,"Changes in QoL and changes in MSIS-29 scores correlated R=0.73 only in EXE.
","['people with MS (PwMS', 'PwMS (n=68, 90% females; age: 47.0y, Expanded Disability Status Scale: 5 to 6']","['PNF and CON', 'exergaming (EXE), balance (BAL), cycling (CYC), proprioceptive neuromuscular facilitation (PNF), and a standard care wait-listed control group (CON', 'EXE and BAL']","['EXE, BAL, and CYC improved MSIS-29 scores', 'MSIS-29 scores', 'Changes in QoL and changes in MSIS-29 scores', 'Multiple Sclerosis Quality of Life and Clinical-Motor Symptoms', 'QoL (EQ-5D), symptoms of depression, gait and balance ability (Tinetti Assessment Tool, TAT), static and dynamic balance and fall risk (Berg Balance Scale (BBS), walking capacity (six-minute walk test, 6MWT), and standing posturography on a force platform', 'gait and balance scores (TAT', 'EXE and CYC improved QoL and walking capacity', 'clinical and motor symptoms and quality of life (QoL', 'fall risk and standing balance']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012383', 'cui_str': 'Dimercaprol'}]","[{'cui': 'C0012383', 'cui_str': 'Dimercaprol'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0034380'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance (observable entity)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0052128', 'cui_str': 'AT III-protease complex'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}]",,0.0254695,"Changes in QoL and changes in MSIS-29 scores correlated R=0.73 only in EXE.
","[{'ForeName': 'József', 'Initials': 'J', 'LastName': 'Tollár', 'Affiliation': 'Somogy County Kaposi Mór Teaching Hospital, Kaposvár, HUNGARY.'}, {'ForeName': 'Ferenc', 'Initials': 'F', 'LastName': 'Nagy', 'Affiliation': 'Somogy County Kaposi Mór Teaching Hospital, Kaposvár, HUNGARY.'}, {'ForeName': 'Béla E', 'Initials': 'BE', 'LastName': 'Tóth', 'Affiliation': 'Department of Pharmacology, Surveillance, and Economics, Faculty of Pharmacy, University of Debrecen, Debrecen, HUNGARY.'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Török', 'Affiliation': 'Somogy County Kaposi Mór Teaching Hospital, Kaposvár, HUNGARY.'}, {'ForeName': 'Kinga', 'Initials': 'K', 'LastName': 'Szita', 'Affiliation': 'Somogy County Kaposi Mór Teaching Hospital, Kaposvár, HUNGARY.'}, {'ForeName': 'Bence', 'Initials': 'B', 'LastName': 'Csutorás', 'Affiliation': 'Somogy County Kaposi Mór Teaching Hospital, Kaposvár, HUNGARY.'}, {'ForeName': 'Mariann', 'Initials': 'M', 'LastName': 'Moizs', 'Affiliation': 'Somogy County Kaposi Mór Teaching Hospital, Kaposvár, HUNGARY.'}, {'ForeName': 'Tibor', 'Initials': 'T', 'LastName': 'Hortobágyi', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, THE NETHERLANDS.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002228']
209,31634898,A multipredictor model to predict the conversion of mild cognitive impairment to Alzheimer's disease by using a predictive nomogram.,"Predicting the probability of converting from mild cognitive impairment (MCI) to Alzheimer's disease (AD) is still a challenging task. This study aims at providing a personalized MCI-to-AD conversion estimation by using a multipredictor nomogram that integrates neuroimaging features, cerebrospinal fluid (CSF) biomarker, and clinical assessments. To do so, 290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI. All subjects were randomly divided into a primary and validation cohort. Radiomics signature (Rad-sig) was obtained based on 17 cerebral cortex features selected by using Least Absolute Shrinkage and Selection Operator (LASSO) algorithm. Clinical factors and amyloid-beta peptide (Aβ) concentration were selected by using Spearman correlation between the converted and not-converted patients. Then, a nomogram that combines image features, clinical factor, and Aβ concentration was constructed and validated. Furthermore, we explored the associations between various predictors from the macro- to the microperspective by assessing gene expression patterns. Our results showed that the multipredictor nomogram (C-index 0.978 and 0.956 in both cohorts, respectively) outperformed the nomogram using either Rad-sig or Aβ concentration as individual predictors. Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways. Our study may have a clinical impact as a powerful predictive tool for predicting the conversion probability of MCI and providing associations between cognitive impairment, structural changes, Aβ levels, and underlying biological patterns from the macro- to the microperspective.",2020,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[""290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI""]",[],"['neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways', 'Clinical factors and amyloid-beta peptide (Aβ) concentration']","[{'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007776', 'cui_str': 'Cortical Plate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0078939', 'cui_str': ""Alzheimer's ABP""}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0173736,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[{'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yubo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Liaojun', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, School of Life Sciences and Technology, Xi'an Jiaotong University, Xi'an, 710049, P. R. China.""}, {'ForeName': 'Liyu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China. huangly@mail.xidian.edu.cn.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0551-0']
210,31764461,Isometric Exercise with Large Muscle Mass Improves Redox Balance and Blood Pressure in Hypertensive Adults.,"PURPOSE


The aim of this study was to investigate the hemodynamic, oxidative stress (OS), and nitric oxide (NO) responses to a submaximal isometric exercise session (IES) involving large muscle mass.
METHODS


Fourteen hypertensive (HTG: age = 35.9 ± 8.1 yr, height = 1.73 ± 0.10 m, total body mass = 78.0 ± 15.8 kg) and 10 normotensive (NTG: age = 41.1 ± 9.4 yr, height = 1.71 ± 0.12 m, total body mass = 82.3 ± 22.4 kg) participants performed two experimental sessions in the leg press and bench press: (i) control session and (ii) 8 sets × 1 min contraction at 30% maximal voluntary isometric contraction with 2-min rest interval. Blood pressure (BP) was measured at rest and during 60 min postexercise. Blood samples were collected at rest, immediately after the session, and 60 min postexercise. NO was obtained through the Griess reaction method. OS parameters were analyzed using commercial kits. A repeated-measures ANOVA with Bonferroni post hoc test was used to analyze all dependent variables.
RESULTS


A significant decrease in systolic BP was observed only for HTG at 45 and 60 min postexercise (baseline vs 45 min: P = 0.03, Δ% = 4.44%; vs 60 min: P = 0.018, Δ% = 5.58%). NO increased immediately postexercise only for HTG (P = 0.008, Δ% = 16.44%). Regarding OS parameters, thiobarbituric acid reactive substances presented a significant reduction 60 min after the IES for NTG and HTG; catalase increased in both groups.
CONCLUSIONS


The data showed that only 8 min of IES with a large muscle mass elicits an elevated pro-oxidant activity leading to a greater NO bioavailability, increases antioxidant reaction, and consequently reduces BP in hypertensive patients.",2020,"Regarding OS parameters, TBARS presented a significant reduction 60 min after the IES for NTG and HTG; catalase increased in both groups.
","['hypertensive patients', 'Fourteen hypertensive (HTG: age: 35.9 ± 8.1 years, height: 1.73 ± 0.10 m, total body mass: 78.0 ± 15.8 kg) and 10 normotensive (NTG: age: 41.1 ± 9.4 years, height: 1.71 ± 0.12 m, total body mass: 82.3 ± 22.4 kg) participants performed', 'Hypertensive Adults']","['2 experimental sessions in the leg press and bench press: i) control session and ii) 8 sets x 1 min contraction at 30% maximal voluntary isometric contraction with 2 min rest interval', 'Isometric Exercise', 'submaximal isometric exercise session (IES']","['hemodynamic, oxidative stress (OS), and nitric oxide (NO) responses', 'Blood samples', 'Blood pressure (BP', 'Redox Balance and Blood Pressure', 'systolic BP']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C4517426', 'cui_str': '0.12 (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0022205', 'cui_str': 'Isometric Contraction'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0030012', 'cui_str': 'Redox'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",60.0,0.0310771,"Regarding OS parameters, TBARS presented a significant reduction 60 min after the IES for NTG and HTG; catalase increased in both groups.
","[{'ForeName': 'Rafael Reis', 'Initials': 'RR', 'LastName': 'Olher', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, DF, BRAZIL.'}, {'ForeName': 'Thiago Santos', 'Initials': 'TS', 'LastName': 'Rosa', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, DF, BRAZIL.'}, {'ForeName': 'Luiz Humberto Rodrigues', 'Initials': 'LHR', 'LastName': 'Souza', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, DF, BRAZIL.'}, {'ForeName': 'José Fernando', 'Initials': 'JF', 'LastName': 'Oliveira', 'Affiliation': 'Department of Physical Education, Paulista University-UNIP, SP, BRAZIL.'}, {'ForeName': 'Brande Ranter Alves', 'Initials': 'BRA', 'LastName': 'Soares', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, DF, BRAZIL.'}, {'ForeName': 'Thiago Belarmino Alves', 'Initials': 'TBA', 'LastName': 'Ribeiro', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, DF, BRAZIL.'}, {'ForeName': 'Ioranny Raquel Castro', 'Initials': 'IRC', 'LastName': 'Souza', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, DF, BRAZIL.'}, {'ForeName': 'Rodrigo Vanerson Passos', 'Initials': 'RVP', 'LastName': 'Neves', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, DF, BRAZIL.'}, {'ForeName': 'Caio Victor', 'Initials': 'CV', 'LastName': 'Sousa', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, DF, BRAZIL.'}, {'ForeName': 'Lysleine Alves', 'Initials': 'LA', 'LastName': 'Deus', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, DF, BRAZIL.'}, {'ForeName': 'Paulo Henrique', 'Initials': 'PH', 'LastName': 'Marchetti', 'Affiliation': 'Department of Kinesiology, California State University, Northridge, CA.'}, {'ForeName': 'Herbert Gustavo', 'Initials': 'HG', 'LastName': 'Simoes', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, DF, BRAZIL.'}, {'ForeName': 'Milton Rocha', 'Initials': 'MR', 'LastName': 'Moraes', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasília, DF, BRAZIL.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002223']
211,32305222,Prognostic Usefulness of Myocardial Work in Patients With Heart Failure and Reduced Ejection Fraction Treated by Sacubitril/Valsartan.,"The noninvasive assessment of myocardial work (MW) by pressure-strain loops analysis (PSL) is a relative new tool for the evaluation of myocardial performance. Sacubitril/Valsartan is a treatment for heart failure with reduced ejection fraction (HFrEF) which has a spectacular effect on the reduction of cardiovascular events (major adverse cardiovascular events [MACEs]). This study aimed to evaluate the short- and medium-term effect of Sacubitril/Valsartan treatment on MW parameters and the prognostic value of MW in this specific group of patients. Seventy-nine patients with HFrEF (mean age: 66 ± 12 years; LV ejection fraction: 28% ± 9%) were prospectively included in the study and treated with Sacubitril/Valsartan. Echocardiographic examination was performed at baseline, and after 6- and 12-month of therapy with Sacubitril/Valsartan. Sacubitril/Valsartan significantly increased myocardial constructive work (CW) (1023 ± 449 vs 1424 ± 484 mm Hg%, p <0.0001) and myocardial work efficiency (WE) [87 (78to 90) vs 90 (86 to 95), p <0.0001]. During FU (2.6 ± 0.9 years), MACEs occurred in 13 (16%) patients. After correction for LV size, LV ejection fraction and WE, global myocardial constructive work (CW) was the only predictor of MACEs [hazard ratio [HR] 0.99 (0.99 to 1.00), p = 0.04]. A CW <910 mm Hg identified patients at particularly increase risk of MACEs [HR 11.09 (1.45 to 98.94), p = 0.002, log-rank test p <0.0001]. In conclusion, in patients with HFrEF who receive a comprehensive background beta-blocker and mineral-corticoid receptor antagonist therapy, Sacubitril/Valsartan induces a significant improvement of myocardial CW and WE. In this population, the estimation of CW before the initiation of Sacubitril/Valsartan allows the prediction of MACEs.",2020,"After correction for LV size, LV ejection fraction and WE, global myocardial constructive work (CW) was the only predictor of MACEs [hazard ratio [HR] 0.99 (0.99 to 1.00), p = 0.04].","['patients', 'Patients With Heart Failure and Reduced Ejection Fraction Treated by', 'Seventy-nine patients with HFrEF (mean age: 66 ± 12 years; LV ejection fraction: 28% ± 9%) were prospectively included in the study and treated with', 'patients with HFrEF who receive a']","['pressure-strain loops analysis (PSL', 'Sacubitril/Valsartan', 'comprehensive background beta-blocker and mineral-corticoid receptor antagonist therapy']","['myocardial CW and WE', 'Echocardiographic examination', 'MACEs', 'myocardial constructive work (CW', 'myocardial work efficiency', 'LV size, LV ejection fraction and WE, global myocardial constructive work (CW']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",79.0,0.0223874,"After correction for LV size, LV ejection fraction and WE, global myocardial constructive work (CW) was the only predictor of MACEs [hazard ratio [HR] 0.99 (0.99 to 1.00), p = 0.04].","[{'ForeName': 'Yanis', 'Initials': 'Y', 'LastName': 'Bouali', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': 'Donal', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Alban', 'Initials': 'A', 'LastName': 'Gallard', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Laurin', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Hubert', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Auriane', 'Initials': 'A', 'LastName': 'Bidaut', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Leclercq', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Galli', 'Affiliation': 'University of Rennes, CHU Rennes, Rennes, France. Electronic address: elena.galli@chu-rennes.fr.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.03.031']
212,32305223,Characteristics and Outcome of Patients ≥75 Years of Age With Prior Coronary Artery Bypass Grafting Admitted for an Acute Coronary Syndrome.,"The prognostic role of previous coronary artery bypass (CABG) in elderly patients admitted to hospital for an acute coronary syndrome (ACS) is unclear. Therefore, the aim of this study was to compare the prognosis of patients aged ≥75 years admitted for an ACS with or without previous history of CABG. The primary outcome of the study was a composite of overall mortality, recurrent nonfatal myocardial infarction, nonfatal stroke, and rehospitalization for heart failure at 1-year follow-up. We included 2,253 ACS patients, aged 81 (78 to 85) years enrolled in 3 multicenter studies (the Italian Elderly ACS study, the LADIES ACS study, and the Elderly ACS 2 randomised trial) - 178 (7.9%) with previous CABG, 2,075 (92.1%) without. Patients with previous CABG had a higher burden of cardiovascular risk factors, lower ejection fraction, and higher creatinine values on admission. However, both at univariate analysis and after adjustment for the most relevant covariates (sex, age, previous myocardial infarction, type of ACS, left ventricular ejection fraction, and serum creatinine on admission), previous CABG did not show any statistically significant association with 1-year outcome (adjusted hazard ratio 0.85; 95% confidence interval 0.61 to 1.19; p = 0.353). In conclusion, our study suggests that elderly ACS patients with previous CABG have worse basal clinical characteristics. Nevertheless, in a broad cohort of patients mostly treated with percutaneous coronary intervention during the index event, previous CABG did not confer independent additional risk of major adverse cardiovascular events at 1-year follow-up.",2020,"Patients with previous CABG had a higher burden of cardiovascular risk factors, lower ejection fraction, and higher creatinine values on admission.","['Patients ≥75 Years of Age', 'patients aged ≥75 years admitted for an ACS with or without previous history of CABG', '2,253 ACS patients, aged 81 (78 to 85) years enrolled in 3 multicenter studies (the Italian Elderly ACS study, the LADIES ACS study, and the Elderly ACS 2 randomised trial', 'elderly ACS patients with previous CABG', 'elderly patients admitted to hospital for an acute coronary syndrome (ACS']","['percutaneous coronary intervention', 'coronary artery bypass (CABG']","['composite of overall mortality, recurrent nonfatal myocardial infarction, nonfatal stroke, and rehospitalization for heart failure at 1-year follow-up', 'cardiovascular risk factors, lower ejection fraction', 'myocardial infarction, type of ACS, left ventricular ejection fraction, and serum creatinine on admission']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0457453', 'cui_str': 'On admission'}]",2253.0,0.0523231,"Patients with previous CABG had a higher burden of cardiovascular risk factors, lower ejection fraction, and higher creatinine values on admission.","[{'ForeName': 'Nuccia', 'Initials': 'N', 'LastName': 'Morici', 'Affiliation': 'Unità di Cure Intensive Cardiologiche, De Gasperis Cardio-Center, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy; Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milano, Italy. Electronic address: nuccia.morici@ospedaleniguarda.it.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'De Rosa', 'Affiliation': 'Cardiology Unit, Cardiovascular and Thoracic Department, University Hospital ""San Giovanni di Dio e Ruggi d\'Aragona"", Salerno, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Crimi', 'Affiliation': 'Interventional Cardiology Unit, Cardio Thoraco Vascular Department, IRCCS Policlinico San Martino, Genova, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'De Luca', 'Affiliation': 'Division of Cardiology, S. Giovanni Evangelista Hospital, Rome, Italy.'}, {'ForeName': 'Luca A', 'Initials': 'LA', 'LastName': 'Ferri', 'Affiliation': 'Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lenatti', 'Affiliation': 'Division of Cardiology, Ospedale Manzoni, Lecco, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Piatti', 'Affiliation': 'Division of Cardiology, Ospedale Manzoni, Lecco, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Tortorella', 'Affiliation': 'Division of Cardiology, Ospedale Vaio, Fidenza, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Grosseto', 'Affiliation': 'Division of Cardiology, Ospedale Infermi, Rimini, Italy.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Franco', 'Affiliation': 'Division of Cardiology, Ospedale Infermi, Rimini, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Bossi', 'Affiliation': 'Unità di Cure Intensive Cardiologiche, De Gasperis Cardio-Center, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Montalto', 'Affiliation': 'Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Antonicelli', 'Affiliation': 'Center of Clinical Pathology and Innovative Therapy, Italian National Research Center on Aging (IRCCS INRCA), Ancona, Italy.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Alicandro', 'Affiliation': 'Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Milano, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'De Luca', 'Affiliation': 'Cardiovascular Department, Ospedale ""Maggiore della Carità"", Eastern Piedmont University, Novara, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'De Servi', 'Affiliation': 'University of Pavia, Pavia, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Savonitto', 'Affiliation': 'Division of Cardiology, Ospedale Manzoni, Lecco, Italy.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.03.021']
213,32306301,Does exercise program of endurance and strength improve health-related quality of life in persons living with HIV-related distal symmetrical polyneuropathy? A randomized controlled trial.,"BACKGROUND


The most common HIV neurological comorbidity, Distal Symmetrical Peripheral Neuropathy (DSPN), is characterized by severe symptoms and reduced quality of life. Exercise has consistently been mentioned as one of the non-pharmacological therapies for the rehabilitation of individuals with HIV, but little is known about an exercise program to recommend to people living with HIV (PLWHIV)-related DSPN. The purpose of this study was to investigate the effectiveness of aerobic (AE) or progressive resisted exercise (PRE) on quality of life (QOL) in a person living with HIV-related DSPN.
METHOD


A randomized controlled trial was conducted with 136 persons living with HIV-related Neuropathy, including 6 domains of QOL within WHOQOL-BREF, 45 in the AE (used ergometer), 44 in the PRE (used quadriceps bench), and 47 in the control group (CG). The outcome measures (QOL) data were analyzed using the inferential statistic of Friedman for within-group with post hoc analysis of Wilcoxon signed Test. A Kruskal-Wallis test was carried out for between-groups with post hoc analysis of Mann-Whitney to find where significant differences exist.
RESULTS


The results indicated significant differences within experimental groups in all six domains p < 0.05. Similarly, the result indicated significant differences within the CG in Physical, level of independence, and Spirituality/Religions domains (p = 0.002, p = 0.035, p = 0.006). However, the results indicated significant differences between experimental groups and CG.
CONCLUSION


These findings indicated that strength and endurance exercise of moderate intensity have a positive effect on QOL in PLWHIV-related DSPN. Clinical trial No. http://apps.who.int/trialsearch/default.aspx (PACTR201707002173240).",2020,"Similarly, the result indicated significant differences within the CG in Physical, level of independence, and Spirituality/Religions domains (p = 0.002, p = 0.035, p = 0.006).","['136 persons living with HIV-related Neuropathy, including 6 domains of QOL within WHOQOL-BREF, 45 in the AE (used ergometer), 44 in the PRE (used quadriceps bench), and 47 in the control group (CG', 'person living with HIV-related DSPN', 'people living with HIV (PLWHIV)-related DSPN', 'persons living with HIV-related distal symmetrical polyneuropathy']","['http://apps.who.int/trialsearch/default.aspx', 'aerobic (AE) or progressive resisted exercise (PRE']","['quality of life (QOL', 'CG in Physical, level of independence, and Spirituality/Religions domains']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0035039', 'cui_str': 'Religion'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]",136.0,0.0980854,"Similarly, the result indicated significant differences within the CG in Physical, level of independence, and Spirituality/Religions domains (p = 0.002, p = 0.035, p = 0.006).","[{'ForeName': 'Abdulsalam Mohammed', 'Initials': 'AM', 'LastName': 'Yakasai', 'Affiliation': 'Department of Physiotherapy, College of Health Science, University of KwaZulu-Natal, Westville Campus, Durban, South Africa. abdulpeace1@gmail.com.'}, {'ForeName': 'Sonill Sooknunan', 'Initials': 'SS', 'LastName': 'Maharaj', 'Affiliation': 'Department of Physiotherapy, College of Health Science, University of KwaZulu-Natal, Westville Campus, Durban, South Africa.'}, {'ForeName': 'Bashir', 'Initials': 'B', 'LastName': 'Kaka', 'Affiliation': 'Department of Physiotherapy, College of Health Science, University of KwaZulu-Natal, Westville Campus, Durban, South Africa.'}, {'ForeName': 'Musa Sani', 'Initials': 'MS', 'LastName': 'Danazumi', 'Affiliation': 'Department of Physiotherapy, College of Allied Health Sciences, Bayero University, kano, Nigeria.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02500-x']
214,32276003,The beneficial role of FeNO in association with GINA guidelines for titration of inhaled corticosteroids in adult asthma: A randomized study.,"PURPOSE


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


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


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


The use of FeNO in association with GINA guidelines has a beneficial role for accurate daily dose of ICS in adult patients with asthma.",2020,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","['symptomatic asthmatic patients', 'adult asthma', 'adult patients with asthma']","['GINA group (followed GINA guidelines; N\xa0=\xa086) or GINA\xa0+\xa0FeNO group (followed GINA guidelines\xa0+\xa0FeNO for titration of inhaled corticosteroids - ICS; N\xa0=\xa090', 'exhaled nitric oxide (FeNO', 'GINA']","['percentage of mild, moderate and severe asthma', 'level of FeNO reduction', 'improvement of asthma control test (ACT) score']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",,0.0308658,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","[{'ForeName': 'Tung', 'Initials': 'T', 'LastName': 'Truong-Thanh', 'Affiliation': 'Department of Internal Medicine, Thanh Hoa General Hospital, Thanh Hoa City, Vietnam.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Vo-Thi-Kim', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Vu-Minh', 'Affiliation': 'Department of Airway Diseases, ENT Institute, Hanoi City, Vietnam.'}, {'ForeName': 'Dung', 'Initials': 'D', 'LastName': 'Truong-Viet', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Huong', 'Initials': 'H', 'LastName': 'Tran-Van', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Sy', 'Initials': 'S', 'LastName': 'Duong-Quy', 'Affiliation': 'Department of Respiratory Diseases, Lam Dong Medical College, Dalat City, Vietnam; Department of Immuno-Allergology, Penn State Medical College, Hershey, USA. Electronic address: sduongquy.jfvp@gmail.com.'}]",Advances in medical sciences,['10.1016/j.advms.2020.03.001']
215,32014649,An experimental study on effects of radiofrequency electromagnetic fields on sleep in healthy elderly males and females: Gender matters!,"BACKGROUND


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


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


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


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


With regard to RF-EMF effects on human sleep it seems that gender matters since GSM900 and TETRA led to significantly more exposure effects in females. Regardless of gender, none of the observed changes is indicative of a sleep disturbing effect of RF-EMF exposure. Observed effects might be mediated by skin related thermoregulatory mechanisms.",2020,"Under GSM exposure, the self-rated total sleep time tended to be longer in females and to be shorter in males.","['healthy elderly males and females', '30 elderly healthy male and 30 healthy elderly female volunteers']","['radiofrequency electromagnetic fields', 'radiofrequency electromagnetic fields (RF-EMF', 'RF-EMF exposures (GSM900 and TETRA']","['macrostructure of sleep and arousals', 'number of awakenings', 'self-rated total sleep time', 'peak spatial absorption rate', 'Latency to sleep stage R', 'time awake within the sleep period under TETRA exposure', 'RF-EMF effects']","[{'cui': 'C0686754', 'cui_str': 'Well male elder (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0686755', 'cui_str': 'Well female elder (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0013835', 'cui_str': 'Electromagnetic Fields'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1010292', 'cui_str': 'Tetras'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C1010292', 'cui_str': 'Tetras'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",30.0,0.0475033,"Under GSM exposure, the self-rated total sleep time tended to be longer in females and to be shorter in males.","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Danker-Hopfe', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of the Freie Universität Berlin, Humboldt Universität zu Berlin, And Berlin Institute of Health, Competence Centre for Sleep Medicine, At the Campus Benjamin Franklin, 12200, Berlin, Germany. Electronic address: heidi.danker-hopfe@charite.de.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Dorn', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of the Freie Universität Berlin, Humboldt Universität zu Berlin, And Berlin Institute of Health, Competence Centre for Sleep Medicine, At the Campus Benjamin Franklin, 12200, Berlin, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Sauter', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of the Freie Universität Berlin, Humboldt Universität zu Berlin, And Berlin Institute of Health, Competence Centre for Sleep Medicine, At the Campus Benjamin Franklin, 12200, Berlin, Germany.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Schmid', 'Affiliation': 'Seibersdorf Laboratories, 2444, Seibersdorf, Austria.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Eggert', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of the Freie Universität Berlin, Humboldt Universität zu Berlin, And Berlin Institute of Health, Competence Centre for Sleep Medicine, At the Campus Benjamin Franklin, 12200, Berlin, Germany.'}]",Environmental research,['10.1016/j.envres.2020.109181']
216,32089436,Relationship Between Vascular Risk Factors and Location of Intracranial Atherosclerosis in the SAMMPRIS Trial.,"BACKGROUND


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


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


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


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


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


Of 449 patients included in the analysis; 289 (64.4%) had ICAS in the anterior circulation and 160 (35.6%) in the posterior circulation.","[{'ForeName': 'Eyad', 'Initials': 'E', 'LastName': 'Almallouhi', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina. Electronic address: almallou@musc.edu.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Al Kasab', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Yamada', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': ""Renee' H"", 'Initials': 'RH', 'LastName': 'Martin', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Marc I', 'Initials': 'MI', 'LastName': 'Chimowitz', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.104713']
217,32307560,Intrinsic connections between thalamic sub-regions and the lateral prefrontal cortex are differentially impacted by acute methylphenidate.,"BACKGROUND


The thalamus is a major target of dopaminergic projections and is densely connected with the prefrontal cortex. A better understanding of how dopamine changes thalamo-cortical communication may shed light on how dopamine supports cognitive function. Methylphenidate has been shown to facilitate cognitive processing and reduce connectivity between the thalamus and lateral prefrontal cortex.
AIMS


The thalamus is a heterogeneous structure, and the present study sought to clarify how the intrinsic connections of thalamic sub-regions are differentially impacted by acute dopamine transporter blockade.
METHODS


Sixty healthy volunteers were orally administered either 20 mg of methylphenidate (N = 29) or placebo (N = 31) in a double-blind, randomized, between-subject design. Multi-echo fMRI was used to assess intrinsic functional connectivity of sub-regions of the thalamus during a resting state scan. An N-back working-memory paradigm provided a measure of cognitive performance.
RESULTS


Acute methylphenidate significantly reduced connectivity of the lateral prefrontal cortex with the motor and somatosensory sub-regions of the thalamus and reduced connectivity with the parietal and visual sub-regions at a trend level. Connectivity with the premotor, prefrontal, and temporal sub-regions was not impacted. The intrinsic connectivity between the thalamus and the lateral prefrontal cortex was not associated with working-memory performance.
CONCLUSIONS


Methylphenidate decreases functional connections between the lateral prefrontal cortex and thalamus broadly, while sparing intrinsic connectivity with thalamic sub-regions involved with working-memory and language related processes. Collectively, our results suggest that the dopamine transporter regulates functional connections between the prefrontal cortex and non-cognitive areas of the thalamus.",2020,"Connectivity with the premotor, prefrontal, and temporal sub-regions was not impacted.",['Sixty healthy volunteers'],"['Methylphenidate', '20\xa0mg of methylphenidate (N\u2009=\u200929) or placebo']",['connectivity of the lateral prefrontal cortex'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]",60.0,0.0421953,"Connectivity with the premotor, prefrontal, and temporal sub-regions was not impacted.","[{'ForeName': 'Adam X', 'Initials': 'AX', 'LastName': 'Gorka', 'Affiliation': 'Section on the Neurobiology of Fear & Anxiety, National Institute of Mental Health, 15K North Drive Rm 300-F, Bethesda, MD, 20892, USA. adam.gorka@nih.gov.'}, {'ForeName': 'Tiffany R', 'Initials': 'TR', 'LastName': 'Lago', 'Affiliation': 'Section on the Neurobiology of Fear & Anxiety, National Institute of Mental Health, 15K North Drive Rm 300-F, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Balderston', 'Affiliation': 'Section on the Neurobiology of Fear & Anxiety, National Institute of Mental Health, 15K North Drive Rm 300-F, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Torrisi', 'Affiliation': 'Section on the Neurobiology of Fear & Anxiety, National Institute of Mental Health, 15K North Drive Rm 300-F, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Bari', 'Initials': 'B', 'LastName': 'Fuchs', 'Affiliation': 'Department of Nutritional Sciences, Penn State University, State College, PA, 16801, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grillon', 'Affiliation': 'Section on the Neurobiology of Fear & Anxiety, National Institute of Mental Health, 15K North Drive Rm 300-F, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': 'Section on the Neurobiology of Fear & Anxiety, National Institute of Mental Health, 15K North Drive Rm 300-F, Bethesda, MD, 20892, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05505-z']
218,31443102,Colonization by B. infantis EVC001 modulates enteric inflammation in exclusively breastfed infants.,"BACKGROUND


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


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


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


Our findings indicate that gut dysbiosis (absence of B. infantis) is associated with increased intestinal inflammation. Early addition of EVC001 to diet represents a novel strategy to prevent enteric inflammation during a critical developmental phase.",2019,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
","['exclusively breastfed infants', 'Stool samples (n\u2009=\u2009120']","['CFU B. infantis EVC001 daily for 21 days (EVC001) or breast milk alone (controls), starting at day 7 postnatal']","['Proinflammatory cytokines', 'intestinal inflammation', 'fecal microbiome', 'Fecal calprotectin concentration', 'enteric inflammation', 'proinflammatory cytokines']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1550661', 'cui_str': 'Feces specimen'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C3889047', 'cui_str': 'Intestinal inflammation'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",1010.0,0.0603489,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants.
","[{'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Henrick', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA. bhenrick2@unl.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chew', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Casaburi', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Brown', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Frese', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Morrison Microscopy Core Research Facility, University of Nebraska, Lincoln, NE, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Smilowitz', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}]",Pediatric research,['10.1038/s41390-019-0533-2']
219,31809408,Tramadol Does Not Improve Performance or Impair Motor Function in Trained Cyclists.,"PURPOSE


To investigate the hypothesis that a therapeutic oral dose of Tramadol improves cycling time trial performance and compromises motor-cognitive performance in highly trained cyclists.
METHODS


Following two familiarization trials, 16 highly trained cyclists completed a preloaded time trial (1 h at 60% of peak power followed by a 15-km time trial) after ingestion of 100 mg Tramadol or placebo in a double-blind placebo-controlled counterbalanced crossover design separated by at least 4 d washout. Visuomotor tracking and math tasks were completed during the preload (n = 10) to evaluate effects on cognition and fine motor performance.
RESULTS


Time trial mean power output (298 ± 42 W vs 294 ± 44 W) and performance (1474 ± 77 s vs 1483 ± 85 s) were similar with Tramadol and placebo treatment, respectively. In addition, there were no differences in perceived exertion, reported pain, blood pH, lactate, or bicarbonate concentrations across trials. Heart rate was higher (P < 0.001) during the Tramadol time trial (171 ± 8 bpm) compared with placebo (167 ± 9 bpm). None of the combined motor-cognitive tasks were impaired by Tramadol ingestion, in fact fine motor performance was slightly improved (P < 0.05) in the Tramadol trial compared with placebo.
CONCLUSIONS


In highly trained cyclists, ingestion of 100 mg Tramadol does not improve performance in a 15-km cycling time trial that was completed after a 1-h preload at 60% peak power. Additionally, a therapeutic dose of Tramadol does not compromise complex motor-cognitive or simple fine motor performances.",2020,"In highly trained cyclists, ingestion of 100 mg Tramadol does not improve performance in a 15-km cycling time trial that was completed after a 1-h preload at 60% peak power.","['highly trained cyclists', 'Trained Cyclists', '16 highly trained cyclists']","['Tramadol or placebo', 'Tramadol and placebo', 'Tramadol', 'placebo']","['cycling time trial performance and compromises motor-cognitive performance', 'Visuomotor tracking and math tasks', 'perceived exertion, reported pain, blood pH, lactate, or bicarbonate concentrations', 'compromise complex motor-cognitive or simple fine motor performances', 'Heart rate', 'Performance or Impair Motor Function']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0005367', 'cui_str': 'Bicarbonate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",16.0,0.515528,"In highly trained cyclists, ingestion of 100 mg Tramadol does not improve performance in a 15-km cycling time trial that was completed after a 1-h preload at 60% peak power.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Bejder', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, DENMARK.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Breenfeldt Andersen', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, DENMARK.'}, {'ForeName': 'Thomas Christian', 'Initials': 'TC', 'LastName': 'Bonne', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, DENMARK.'}, {'ForeName': 'Jacob Feder', 'Initials': 'JF', 'LastName': 'Piil', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, DENMARK.'}, {'ForeName': 'Linn Camilla Hauan', 'Initials': 'LCH', 'LastName': 'Hagen', 'Affiliation': 'Norwegian Doping Control Laboratory, Oslo University Hospital, Oslo, NORWAY.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Dehnes', 'Affiliation': 'Norwegian Doping Control Laboratory, Oslo University Hospital, Oslo, NORWAY.'}, {'ForeName': 'Kasper Hvid', 'Initials': 'KH', 'LastName': 'Eibye', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, DENMARK.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nybo', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, DENMARK.'}, {'ForeName': 'Nikolai Baastrup', 'Initials': 'NB', 'LastName': 'Nordsborg', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, DENMARK.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002217']
220,32013700,"Vitamin C Intravenous Treatment In the Setting of Atrial Fibrillation Ablation: Results From the Randomized, Double-Blinded, Placebo-Controlled CITRIS-AF Pilot Study.","Background Catheter ablation is an effective treatment for atrial fibrillation (AF), but high levels of post-procedure inflammation predict adverse clinical events. Ascorbic acid (AA) has shown promise in reducing inflammation but is untested in this population. We sought to test the feasibility, safety, and preliminary effects on inflammatory biomarkers in the CITRIS-AF (Vitamin C Intravenous Treatment In the Setting of Atrial Fibrillation Ablation) pilot study. Methods and Results Patients scheduled to undergo AF ablation (N=20) were randomized 1:1 to double-blinded treatment with AA (200 mg/kg divided over 24 hours) or placebo. C-reactive protein and interleukin-6 levels were obtained before the first infusion and repeated at 24 hours and 30 days. Pain levels within 24 hours and early recurrence of AF within 90 days were recorded. Median and interquartile range were aged 63 (56-70) years, 13 (65%) men, and 18 (90%) white. Baseline data were similar between the 2 groups except ejection fraction. Baseline C-reactive protein levels were 2.56 (1.47-5.87) mg/L and similar between groups ( P =0.48). Change in C-reactive protein from baseline to 24 hours was +10.79 (+6.56-23.19) mg/L in the placebo group and +3.01 (+0.40-5.43) mg/L in the AA group ( P =0.02). Conversely, change in interleukin-6 was numerically higher in the AA group, though not statistically significant ( P =0.32). One patient in each arm developed pericarditis; no adverse events related to the infusions were seen. There were no significant differences between aggregated post-procedure pain levels within 24 hours or early recurrence of AF (both  P >0.05). Conclusions High-dose AA is safe and well tolerated at the time of AF ablation and may be associated with a blunted rise in C-reactive protein, although consistent findings were not seen in interleukin-6 levels. Further studies are needed to validate these findings and explore the potential benefit in improving clinically relevant outcomes. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT03148236.",2020,There were no significant differences between aggregated post-procedure pain levels within 24 hours or early recurrence of AF (both  P >0.05).,"['Median and interquartile range were aged 63 (56-70) years, 13 (65%) men, and 18 (90%) white', 'Patients scheduled to undergo AF ablation (N=20']","['Placebo', ' Catheter ablation', 'placebo', 'CITRIS-AF (Vitamin C Intravenous Treatment', 'Vitamin C Intravenous Treatment', 'AA', 'Ascorbic acid (AA']","['aggregated post-procedure pain levels', 'pericarditis; no adverse events', 'change in interleukin-6', 'Pain levels', 'Change in C-reactive protein', 'C-reactive protein and interleukin-6 levels', 'Baseline C-reactive protein levels']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0162563', 'cui_str': 'Catheter Ablation'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C1963761', 'cui_str': 'No adverse event'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.498453,There were no significant differences between aggregated post-procedure pain levels within 24 hours or early recurrence of AF (both  P >0.05).,"[{'ForeName': 'Cory R', 'Initials': 'CR', 'LastName': 'Trankle', 'Affiliation': 'Division of Cardiology Pauley Heart Center Virginia Commonwealth University Richmond VA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Puckett', 'Affiliation': 'Johnson Center for Critical Care and Pulmonary Research Virginia Commonwealth University Richmond VA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Swift-Scanlan', 'Affiliation': 'School of Nursing Virginia Commonwealth University Richmond VA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'DeWilde', 'Affiliation': 'Johnson Center for Critical Care and Pulmonary Research Virginia Commonwealth University Richmond VA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Priday', 'Affiliation': 'Johnson Center for Critical Care and Pulmonary Research Virginia Commonwealth University Richmond VA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Sculthorpe', 'Affiliation': 'Investigational Drug Service Virginia Commonwealth University Richmond VA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Ellenbogen', 'Affiliation': 'Division of Cardiology Pauley Heart Center Virginia Commonwealth University Richmond VA.'}, {'ForeName': 'Alpha', 'Initials': 'A', 'LastName': 'Fowler', 'Affiliation': 'Johnson Center for Critical Care and Pulmonary Research Virginia Commonwealth University Richmond VA.'}, {'ForeName': 'Jayanthi N', 'Initials': 'JN', 'LastName': 'Koneru', 'Affiliation': 'Division of Cardiology Pauley Heart Center Virginia Commonwealth University Richmond VA.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.014213']
221,31514201,The effect of methylphenidate on social cognition and oxytocin in children with attention deficit hyperactivity disorder.,"The current study aimed to explore the possible effect of stimulants on oxytocin (OT), a neuropeptide which regulates social behavior, as a mediator of the pro-social effect of methylphenidate (MPH) in children with attention deficit hyperactivity disorder (ADHD) compared to healthy controls (HCs). Utilizing a double-blind placebo-controlled design, we compared the performance of 50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks and examined the effect of a single dose of MPH/placebo on ToM and salivary OT levels in children with ADHD at baseline and following an interpersonal interaction. Children with ADHD displayed significantly poorer ToM performance; however, following MPH administration, their performance normalized and differences between children with ADHD and HC were no longer found. Salivary OT levels at baseline did not differ between children with ADHD and HCs. However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD. Administration of MPH attenuated this difference such that after parent-child interaction differences in OT levels between children with ADHD and HC were no longer found. In the ADHD group, OT levels decreased from administration of placebo to the parent-child interaction. However, the administration of MPH to children with ADHD was associated with an increase in OT levels after the parent-child interaction. We conclude that OT might play a role as a mediator of social deficits in children with ADHD and that the reactivity of the OT system to social interaction in children with ADHD might be impaired. Stimulants may improve ToM and social functions in children with ADHD via its impact on the OT system. PRS: OT and Social Cognition in Children with ADHD: Impact of MPH.",2020,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","['Children with ADHD', 'children with attention deficit hyperactivity disorder (ADHD', '50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks', 'children with ADHD at baseline and following an interpersonal interaction', 'children with attention deficit hyperactivity disorder', 'children with ADHD']","['methylphenidate', 'HC', 'MPH', 'MPH/placebo', 'oxytocin (OT', 'placebo', 'methylphenidate (MPH']","['ToM and social functions', 'poorer ToM performance', 'Salivary OT levels', 'social cognition and oxytocin', 'ToM and salivary OT levels', 'OT levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",50.0,0.04804,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","[{'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Levi-Shachar', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hila Z', 'Initials': 'HZ', 'LastName': 'Gvirts', 'Affiliation': 'Department of Behavioral Sciences and Psychology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Goldwin', 'Affiliation': 'Shalvata Mental Health Center, Hod-Hasharon, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Shamay-Tsoory', 'Affiliation': 'Department of Psychology, Haifa University, Haifa, Israel.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Zagoory-Sharon', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Feldman', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Maoz', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. hagaima@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0522-5']
222,31880964,Phase III Study of Adjuvant Ipilimumab (3 or 10 mg/kg) Versus High-Dose Interferon Alfa-2b for Resected High-Risk Melanoma: North American Intergroup E1609.,"PURPOSE


Phase III adjuvant trials have reported significant benefits in both relapse-free survival (RFS) and overall survival (OS) for high-dose interferon alfa (HDI) and ipilimumab at 10 mg/kg (ipi10). E1609 evaluated the safety and efficacy of ipilimumab at 3 mg/kg (ipi3) and ipi10 versus HDI.
PATIENTS AND METHODS


E1609 was a phase III trial in patients with resected cutaneous melanoma (American Joint Committee on Cancer 7th edition stage IIIB, IIIC, M1a, or M1b). It had 2 coprimary end points: OS and RFS. A 2-step hierarchic approach first evaluated ipi3 versus HDI followed by ipi10 versus HDI.
RESULTS


Between May 2011 and August 2014, 1,670 adult patients were centrally randomly assigned (1:1:1) to ipi3 (n = 523), HDI (n = 636), or ipi10 (n = 511). Treatment-related adverse events grade ≥ 3 occurred in 37% of patients receiving ipi3, 79% receiving HDI, and 58% receiving ipi10, with adverse events leading to treatment discontinuation in 35%, 20%, and 54%, respectively. Comparison of ipi3 versus HDI used an intent-to-treat analysis of concurrently randomly assigned patient cases (n = 1,051) and showed significant OS difference in favor of ipi3 (hazard ratio [HR], 0.78; 95.6% repeated CI, 0.61 to 0.99;  P  = .044; RFS: HR, 0.85; 99.4% CI, 0.66 to 1.09;  P  = .065). In the second step, for ipi10 versus HDI (n = 989), trends in favor of ipi10 did not achieve statistical significance. Salvage patterns after melanoma relapse showed significantly higher rates of ipilimumab and ipilimumab/anti-programmed death 1 use in the HDI arm versus ipi3 and ipi10 ( P  ≤ .001).
CONCLUSION


Adjuvant therapy with ipi3 benefits survival versus HDI; for the first time to our knowledge in melanoma adjuvant therapy, E1609 has demonstrated a significant improvement in OS against an active control regimen. The currently approved adjuvant ipilimumab dose (ipi10) was more toxic and not superior in efficacy to HDI.",2020,"Adjuvant therapy with ipi3 benefits survival versus HDI; for the first time to our knowledge in melanoma adjuvant therapy, E1609 has demonstrated a significant improvement in OS against an active control regimen.","['E1609 was a phase III trial in patients with resected cutaneous melanoma (American Joint Committee on Cancer 7th edition stage IIIB, IIIC, M1a, or M1b', 'Between May 2011 and August 2014, 1,670 adult patients']","['interferon alfa (HDI) and ipilimumab', 'Interferon Alfa-2b', 'Adjuvant Ipilimumab', 'HDI', 'ipilimumab']","['OS and RFS', 'safety and efficacy', 'relapse-free survival (RFS) and overall survival (OS']","[{'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0441915', 'cui_str': 'AJCC'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0021735', 'cui_str': 'Interferon Alfa-2b'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",1670.0,0.211354,"Adjuvant therapy with ipi3 benefits survival versus HDI; for the first time to our knowledge in melanoma adjuvant therapy, E1609 has demonstrated a significant improvement in OS against an active control regimen.","[{'ForeName': 'Ahmad A', 'Initials': 'AA', 'LastName': 'Tarhini', 'Affiliation': 'H. Lee Moffitt Comprehensive Cancer Center, Tampa, FL.'}, {'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Harvard Medical School, Boston, MA.'}, {'ForeName': 'F Stephen', 'Initials': 'FS', 'LastName': 'Hodi', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Uma N M', 'Initials': 'UNM', 'LastName': 'Rao', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Gary I', 'Initials': 'GI', 'LastName': 'Cohen', 'Affiliation': 'Greater Baltimore Medical Center, Baltimore, MD.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'Angeles Clinic & Research Institute, Santa Monica, CA.'}, {'ForeName': 'Laura F', 'Initials': 'LF', 'LastName': 'Hutchins', 'Affiliation': 'University of Arkansas, Little Rock, AR.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Sosman', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Harriett M', 'Initials': 'HM', 'LastName': 'Kluger', 'Affiliation': 'Yale University, New Haven, CT.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Eroglu', 'Affiliation': 'H. Lee Moffitt Comprehensive Cancer Center, Tampa, FL.'}, {'ForeName': 'Henry B', 'Initials': 'HB', 'LastName': 'Koon', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Lawrence', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Kari L', 'Initials': 'KL', 'LastName': 'Kendra', 'Affiliation': 'Ohio State University, Columbus, OH.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Minor', 'Affiliation': 'Sutter-California Pacific Medical Center, San Francisco, CA.'}, {'ForeName': 'Carrie B', 'Initials': 'CB', 'LastName': 'Lee', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Albertini', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Lawrence E', 'Initials': 'LE', 'LastName': 'Flaherty', 'Affiliation': 'Wayne State University/Karmanos Cancer Institute, Detroit, MI.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Petrella', 'Affiliation': 'Odette Cancer Center, Toronto, Ontario, Canada.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Streicher', 'Affiliation': 'National Cancer Institute, Rockville, MD.'}, {'ForeName': 'Vernon K', 'Initials': 'VK', 'LastName': 'Sondak', 'Affiliation': 'H. Lee Moffitt Comprehensive Cancer Center, Tampa, FL.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kirkwood', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, PA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01381']
223,31590179,Influence of combined treatment with naltrexone and memantine on alcohol drinking behaviors: a phase II randomized crossover trial.,"Glutamate and opioid systems play important roles in alcohol drinking behaviors. We examined if combined treatment with the NMDA antagonist memantine and the opioid antagonist naltrexone, when compared with naltrexone alone, would have a greater influence on alcohol drinking behaviors. Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism, participated in a randomized, double-blind, crossover trial, including two 6-8 days treatment periods, separated by a 6-day washout, and 3 alcohol drinking paradigm (ADP) sessions. After the first baseline (BAS) ADP1 session, participants were randomized to receive either naltrexone (NTX; 50 mg/day) + placebo memantine, or NTX (50 mg/day) + memantine (MEM; 20 mg/day), during the first treatment period, following which they completed ADP2. After a 6-day washout, participants were crossed over to the treatment they did not receive during the first treatment period, following which they completed ADP3. During each ADP, participants received a priming drink of alcohol followed by 3 1-hour, self-administration periods during which they had ad-lib access to 12 drinks. Individually, both NTX and NTX + MEM, when compared to BAS ADP1, significantly reduced the number of drinks consumed (p's < 0.001) and craving (p's < 0.001). When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004). Specifically, when NTX + MEM followed NTX alone, NTX + MEM resulted in a further reduction in drinking (mean: -1.94; 95% CI: -2.6, -0.8, p = 0.0005). However, when NTX alone followed NTX + MEM, NTX alone did not lead to further reduction in drinking (mean: 0.59; 95% CI: -0.67, 1.43, p = 0.47). Similar patterns were observed for alcohol craving; specifically, a significant reduction in craving was observed when NTX + MEM followed NTX alone (p = 0.009), but craving reduction was maintained when NTX + MEM was followed by NTX alone. Neither treatment condition significantly influenced alcohol-induced stimulation or sedation. Memantine (at a dose of 20 mg/day) enhances the efficacy of naltrexone (50 mg/day) in reducing alcohol drinking and craving among FHP drinkers with beneficial effects that appear to carryover after discontinuation of memantine treatment.",2020,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","['Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism']","['Memantine', 'naltrexone', 'NTX\u2009+\u2009MEM vs. NTX', 'NMDA antagonist memantine', 'NTX', 'alcohol drinking paradigm (ADP) sessions', 'naltrexone (NTX; 50\u2009mg/day)\u2009+\u2009placebo memantine, or NTX (50\u2009mg/day)\u2009+\u2009memantine (MEM', 'opioid antagonist naltrexone', 'naltrexone and memantine', 'priming drink of alcohol']","['craving', 'alcohol craving', 'alcohol drinking behaviors', 'craving reduction', 'number of drinks consumed', 'alcohol drinking and craving', 'alcohol-induced stimulation or sedation']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0559555', 'cui_str': 'FH - Alcoholism'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0565662', 'cui_str': 'Finding relating to alcohol drinking behavior'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",12.0,0.0285429,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","[{'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA. suchitra.krishnan-sarin@yale.edu.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Franco', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Cavallo', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Tetrault', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0536-z']
224,32233095,Impact of the type of anthracycline and of stem cell transplantation in younger patients with acute myeloid leukaemia: Long-term follow up of a phase III study.,"We provide a long-term evaluation of patients enrolled in the EORTC/GIMEMA AML-10 trial which included a total of 2157 patients, 15-60 years old, randomized to receive either daunorubicin (DNR, 50 mg/m 2  ), mitoxantrone (MXR, 12 mg/m 2  ), or idarubicin (IDA, 10 mg/m 2  ) in addition to standard-dose cytarabine and etoposide for induction chemotherapy and intermediate dose cytarabine for consolidation. Younger patients who reached complete remission with complete (CR) or incomplete (CRi) recovery were then scheduled to receive an allogeneic hematopoietic stem cell transplantation (HSCT). That was if they had a HLA-identical sibling donor; in all other cases, an autologous HSCT had to be administered. At an 11-year median follow-up, the 5-year, 10-year and 15-year overall survival (OS) rates were 33.2%, 30.1% and 28.0%, respectively. No significant difference between the three randomized groups regarding OS was observed (P = .38). In young patients, 15-45 years old, no treatment difference (P = .89) regarding OS was observed, while in patients 46-60 years old, MXR and IDA groups had a trend for a longer OS as compared to the DNR group (P = .029). Among younger patients without a favorable MRC cytogenetic risk subgroup who achieved a CR/CRi after induction chemotherapy, those with a HLA-identical sibling donor had higher 10-year and 15-year OS rates than those without. In older patients who reached CR/CRi, the long-term outcomes of those with or without a donor was similar. In conclusion, long-term outcomes of the study confirmed similar OS in the three randomized groups in the whole cohort of patients.",2020,"In young patients, 15-45 years old, no treatment difference (P=0.89) regarding OS was observed, while in patients 46-60 years old, MXR and IDA groups had a trend for a longer OS as compared to the DNR group (P=0.029).","['younger patients with acute myeloid leukaemia', 'Younger patients who reached complete remission with complete (CR) or incomplete (CRi) recovery', 'patients enrolled in the EORTC/GIMEMA AML-10 trial which included a total of 2157 patients, 15-60\u2009years old', 'younger patients without a favourable MRC cytogenetic risk subgroup']","['daunorubicin (DNR, 50 mg/m 2  ), mitoxantrone (MXR, 12 mg/m 2  ), or idarubicin (IDA, 10 mg/m 2  ) in addition to standard-dose cytarabine and etoposide for induction chemotherapy and intermediate dose cytarabine', 'anthracycline and of stem cell transplantation', 'allogeneic hematopoietic stem cell transplantation (HSCT']","['15-year overall survival (OS) rates', 'OS']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0582114', 'cui_str': 'DNAR - Do not attempt resuscitation'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",2157.0,0.159809,"In young patients, 15-45 years old, no treatment difference (P=0.89) regarding OS was observed, while in patients 46-60 years old, MXR and IDA groups had a trend for a longer OS as compared to the DNR group (P=0.029).","[{'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Baron', 'Affiliation': 'GIGA-I3 and CHU, University of Liège, Liège, Belgium.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Efficace', 'Affiliation': ""Gruppo Italiano Malattie Ematologiche Dell'Adulto GIMEMA, Rome, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cannella', 'Affiliation': ""Gruppo Italiano Malattie Ematologiche Dell'Adulto GIMEMA, Rome, Italy.""}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Muus', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Trisolini', 'Affiliation': 'Sapienza University, Rome, Italy.'}, {'ForeName': 'Constantijn J M', 'Initials': 'CJM', 'LastName': 'Halkes', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Fazi', 'Affiliation': ""Gruppo Italiano Malattie Ematologiche Dell'Adulto GIMEMA, Rome, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Vignetti', 'Affiliation': ""Gruppo Italiano Malattie Ematologiche Dell'Adulto GIMEMA, Rome, Italy.""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Marie', 'Affiliation': 'Saint-Antoine Hospital, Paris, France.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Chiusolo', 'Affiliation': 'Gemelli Hospital, Rome, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'van der Velden', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Edoardo', 'Initials': 'E', 'LastName': 'La Sala', 'Affiliation': ""Gruppo Italiano Malattie Ematologiche Dell'Adulto GIMEMA, Rome, Italy.""}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Vitolo', 'Affiliation': 'Candiolo Cancer Institute-IRCCS, Torino, Italy.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Thomas', 'Affiliation': 'Lyon-Sud University Hospital, Lyon, France.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Lefrère', 'Affiliation': ""Assistance Publique-Hôpitaux de Paris, Necker Children's Hospital, Paris, France.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Di Raimondo', 'Affiliation': 'Universita di Catania, Catania, Italy.'}, {'ForeName': 'Jean-Henri', 'Initials': 'JH', 'LastName': 'Bourhis', 'Affiliation': 'Gustave Roussy cancer campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Giorgina', 'Initials': 'G', 'LastName': 'Specchia', 'Affiliation': 'Giovanni XXIII- University Hospital, Bari, Italy.'}, {'ForeName': 'José E', 'Initials': 'JE', 'LastName': 'Guimarães', 'Affiliation': 'Hospital S. João, Porto, Portugal.'}, {'ForeName': 'Bernardino', 'Initials': 'B', 'LastName': 'Allione', 'Affiliation': 'Candiolo Cancer Institute-IRCCS, Torino, Italy.'}, {'ForeName': 'Radovan', 'Initials': 'R', 'LastName': 'Vrhovac', 'Affiliation': 'University Hospital Centre Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Felicetto', 'Initials': 'F', 'LastName': 'Ferrara', 'Affiliation': 'Cardarelli Hospital, Naples, Italy.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Stevens-Kroef', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Liv', 'Initials': 'L', 'LastName': 'Meert', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'de Witte', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Roelof', 'Initials': 'R', 'LastName': 'Willemze', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Amadori', 'Affiliation': 'University Tor Vergata, Rome, Italy.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Suciu', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}]",American journal of hematology,['10.1002/ajh.25795']
225,32142372,Omalizumab for Aspirin Hypersensitivity and Leukotriene Overproduction in Aspirin-exacerbated Respiratory Disease. A Randomized Controlled Trial.,"Rationale:  Aspirin-exacerbated respiratory disease is characterized by severe asthma, nonsteroidal antiinflammatory drug hypersensitivity, nasal polyposis, and leukotriene overproduction. Systemic corticosteroid therapy does not completely suppress lifelong aspirin hypersensitivity. Omalizumab efficacy against aspirin-exacerbated respiratory disease has not been investigated in a randomized manner. Objectives:  To evaluate omalizumab efficacy against aspirin hypersensitivity, leukotriene E 4  overproduction, and symptoms during an oral aspirin challenge in patients with aspirin-exacerbated respiratory disease using a randomized design. Methods:  We performed a double-blind, randomized, crossover, placebo-controlled, single-center study at Sagamihara National Hospital between August 2015 and December 2016. Atopic patients (20-79 yr old) with aspirin-exacerbated respiratory disease diagnosed by systemic aspirin challenge were randomized (1:1) to a 3-month treatment with omalizumab or placebo, followed by a >18-week washout period (crossover design). The primary endpoint was the difference in area under logarithm level of urinary leukotriene E 4  concentration versus time curve in the intent-to-treat population during an oral aspirin challenge. Measurements and Main Results:  Sixteen patients completed the study and were included in the analysis. The area under the logarithm level of urinary leukotriene E 4  concentration versus time curve during an oral aspirin challenge was significantly lower in the omalizumab phase (median [interquartile range], 51.1 [44.5-59.8]) than in the placebo phase (80.8 [interquartile range, 65.4-87.8]) ( P  < 0.001). Ten of 16 patients (62.5%) developed oral aspirin tolerance up to cumulative doses of 930 mg in the omalizumab phase ( P  < 0.001). Conclusions:  Omalizumab treatment inhibited urinary leukotriene E 4  overproduction and upper/lower respiratory tract symptoms during an oral aspirin challenge, resulting in aspirin tolerance in 62.5% of the patients with aspirin-exacerbated respiratory disease.",2020,"CONCLUSIONS


Omalizumab treatment inhibited urinary leukotriene E 4  overproduction and upper/lower respiratory tract symptoms during oral aspirin challenge, resulting in aspirin tolerance in 62.5% of aspirin-exacerbated respiratory disease patients.","['Atopic patients aged 20-79 years with aspirin-exacerbated respiratory disease diagnosed by systemic aspirin challenge', 'exacerbated respiratory disease patients', 'controlled, single-centre study at Sagamihara National Hospital between August 2015 and December 2016', 'Sixteen patients completed the study and were included in the analysis']","['omalizumab or placebo', 'aspirin', 'placebo', 'https://www.umin.ac.jp/ctr/index.htm, ID', 'aspirin-hypersensitivity, leukotriene E', 'Omalizumab', 'Systemic corticosteroid therapy']","['aspirin tolerance', 'urinary leukotriene E 4  overproduction and upper/lower respiratory tract symptoms', 'area under logarithm level of urinary leukotriene E 4  concentration vs time curve', 'oral aspirin tolerance']","[{'cui': 'C0392707', 'cui_str': 'Atopy (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3853540', 'cui_str': 'Samter syndrome'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1444749', 'cui_str': 'Exacerbated (qualifier value)'}, {'cui': 'C0035204', 'cui_str': 'Respiration Disorders'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0064855', 'cui_str': 'Leukotrienes E'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0125644', 'cui_str': 'LTE4'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0282335', 'cui_str': 'Respiratory Tract'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",,0.296549,"CONCLUSIONS


Omalizumab treatment inhibited urinary leukotriene E 4  overproduction and upper/lower respiratory tract symptoms during oral aspirin challenge, resulting in aspirin tolerance in 62.5% of aspirin-exacerbated respiratory disease patients.","[{'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Yuma', 'Initials': 'Y', 'LastName': 'Fukutomi', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Mitsui', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Kajiwara', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Watai', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Kamide', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Yuto', 'Initials': 'Y', 'LastName': 'Hamada', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Tomita', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Sekiya', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tsuburai', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Izuhara', 'Affiliation': 'Division of Medical Biochemistry, Department of Biomolecular Sciences, Saga Medical School, Saga, Japan; and.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Wakahara', 'Affiliation': 'Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Naozumi', 'Initials': 'N', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Taniguchi', 'Affiliation': 'Clinical Research Center for Allergy and Rheumatology, National Hospital Organization Sagamihara National Hospital, Sagamihara, Japan.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201906-1215OC']
226,32273271,A Randomized Controlled Trial Comparing Glargine U300 and Glargine U100 for the Inpatient Management of Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial.,"OBJECTIVE


The role of U300 glargine insulin for the inpatient management of type 2 diabetes (T2D) has not been determined. We compared the safety and efficacy of glargine U300 versus glargine U100 in noncritically ill patients with T2D.
RESEARCH DESIGN AND METHODS


This prospective, open-label, randomized clinical trial included 176 patients with poorly controlled T2D (admission blood glucose [BG] 228 ± 82 mg/dL and HbA 1c  9.5 ± 2.2%), treated with oral agents or insulin before admission. Patients were treated with a basal-bolus regimen with glargine U300 ( n  = 92) or glargine U100 ( n  = 84) and glulisine before meals. We adjusted insulin daily to a target BG of 70-180 mg/dL. The primary end point was noninferiority in the mean difference in daily BG between groups. The major safety outcome was the occurrence of hypoglycemia.
RESULTS


There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL,  P  = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%,  P  = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days,  P  = 0.06), hospital complications (6.5% vs. 11%,  P  = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day,  P  = 0.74). There were no differences in the proportion of patients with BG <70 mg/dL (8.7% vs. 9.5%,  P  > 0.99), but glargine U300 resulted in significantly lower rates of clinically significant hypoglycemia (<54 mg/dL) compared with glargine U100 (0% vs. 6.0%,  P  = 0.023).
CONCLUSIONS


Hospital treatment with glargine U300 resulted in similar glycemic control compared with glargine U100 and may be associated with a lower incidence of clinically significant hypoglycemia.",2020,"There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL,  P  = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%,  P  = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days,  P  = 0.06), hospital complications (6.5% vs. 11%,  P  = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day,  P  = 0.74).","['type 2 diabetes (T2D', 'Medicine and Surgery Patients With Type 2 Diabetes: Glargine U300 Hospital Trial', '176 patients with poorly controlled T2D (admission blood glucose [BG] 228 ± 82 mg/dL and HbA 1c  9.5 ± 2.2%), treated with oral agents or insulin before admission', 'noncritically ill patients with T2D.\nMETHODS']","['Glargine U300 and Glargine U100', 'U300 glargine insulin', 'glargine U300 versus glargine', 'glargine U100', 'glargine U300']","['percentage of readings within target BG', 'safety and efficacy', 'rates of clinically significant hypoglycemia', 'length of stay', 'hospital complications', 'occurrence of hypoglycemia']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",176.0,0.187812,"There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL,  P  = 0.62), percentage of readings within target BG of 70-180 mg/dL (50 ± 27% vs. 55 ± 29%,  P  = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days,  P  = 0.06), hospital complications (6.5% vs. 11%,  P  = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day,  P  = 0.74).","[{'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Pasquel', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'M Cecilia', 'Initials': 'MC', 'LastName': 'Lansang', 'Affiliation': 'The Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'Ameer', 'Initials': 'A', 'LastName': 'Khowaja', 'Affiliation': 'Hennepin County Medical Center, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'M Agustina', 'Initials': 'MA', 'LastName': 'Urrutia', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Saumeth', 'Initials': 'S', 'LastName': 'Cardona', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Albury', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Rodolfo J', 'Initials': 'RJ', 'LastName': 'Galindo', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Fayfman', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Migdal', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Priyathama', 'Initials': 'P', 'LastName': 'Vellanki', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA.'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA geumpie@emory.edu.'}]",Diabetes care,['10.2337/dc19-1940']
227,31129681,Maternal anemia type during pregnancy is associated with anemia risk among offspring during infancy.,"BACKGROUND


We evaluated the association between etiology of maternal anemia and iron status throughout infancy.
METHODS


Samples from a study designed to examine Praziquantel treatment during pregnancy were used (n = 359). All women were infected with schistosomiasis and randomized to Praziquantel or placebo at 16 ± 2 weeks' gestation. Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood. The relationship between both maternal Praziquantel treatment and etiology of anemia and infant iron status was evaluated.
RESULTS


Maternal iron-deficiency anemia was associated with increased risk of infant anemia at 6 months of age. Infants of mothers with the lowest levels of circulating hepcidin during gestation, likely a marker for iron deficiency, had higher sTfR:SF levels and lower hemoglobin levels, particularly at 12 months of age. Maternal non-iron-deficiency anemia (NIDA) did not impact infant anemia risk or iron status. Maternal treatment for schistosomiasis had no effect on infant hematologic status.
CONCLUSIONS


Maternal iron deficiency anemia was associated with an increased risk for anemia or iron deficiency during late infancy. We did not observe an association between maternal NIDA and increased risk for iron deficiency during infancy.",2019,"Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood.",['All women were infected with schistosomiasis and randomized to'],"['Praziquantel or placebo', 'Praziquantel']","['sTfR', 'SF levels and lower hemoglobin levels', 'risk of infant anemia', 'Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6', 'Maternal anemia type', 'etiology of anemia and infant iron status', 'Maternal iron-deficiency anemia', 'Maternal non-iron-deficiency anemia (NIDA']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036323', 'cui_str': 'Schistoma Infection'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble (substance)'}, {'cui': 'C0966897', 'cui_str': 'Liver-Expressed Antimicrobial Peptide'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0068218', 'cui_str': 'NIDA'}]",,0.133641,"Hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), hepcidin, C-reactive protein, and interleukin-6 were measured in maternal and infant blood.","[{'ForeName': 'Ajibola I', 'Initials': 'AI', 'LastName': 'Abioye', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'McDonald', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Sangshin', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA. spark@uos.ac.kr.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ripp', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Brady', 'Initials': 'B', 'LastName': 'Bennett', 'Affiliation': 'Center for International Health Research, Rhode Island Hospital, The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Hannah W', 'Initials': 'HW', 'LastName': 'Wu', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Sunthorn', 'Initials': 'S', 'LastName': 'Pond-Tor', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Marianne J', 'Initials': 'MJ', 'LastName': 'Sagliba', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Amabelle J', 'Initials': 'AJ', 'LastName': 'Amoylen', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Palmera I', 'Initials': 'PI', 'LastName': 'Baltazar', 'Affiliation': 'Remedios Trinidad Romualdez Hospital, Tacloban City, Leyte, The Philippines.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tallo', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Luz P', 'Initials': 'LP', 'LastName': 'Acosta', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Remigio M', 'Initials': 'RM', 'LastName': 'Olveda', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Kurtis', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Friedman', 'Affiliation': 'The Warren Alpert Medical School of Brown University, Providence, RI, USA.'}]",Pediatric research,['10.1038/s41390-019-0433-5']
228,30804459,The impact of upper-limb position on estimated central blood pressure waveforms.,"Pulse wave analysis (PWA) utilizes arm blood pressure (BP) waveforms to estimate aortic waveforms. The accuracy of central BP waveform estimation may be influenced by assessment site local haemodynamics. This study investigated whether local haemodynamic changes, induced via arm tilting ±30° relative to heart level, affect estimated central systolic BP (cSBP) and arterial wave reflection (central augmentation index, cAIx; aortic backward pressure wave, Pb). In 20 healthy adults (26.7 years [SD 5.2], 10 F) brachial BP waveforms were simultaneously recorded on experimental and control arms. The experimental arm was randomly repositioned three times (heart level, -30° heart level, +30° heart level), while the control arm remained fixed at heart level. For the experimental arm, arm repositioning resulted in a large (partial eta-squared > 0.14) effect size (ES) change in SBP (ES = 0.75, P < 0.001), cSBP (ES = 0.81, P < 0.001), and cAIx (ES = 0.75, P = 0.002), but not Pb (ES = 0.06, P = 0.38). In the control arm, cAIx (ES = 0.22, P = 0.013) but not SBP or cSBP significantly changed. Change in experimental arm cSBP was partially explained by brachial systolic blood velocity (P = 0.026) and mean diameter (P = 0.012), while change in cAIx was associated with brachial retrograde blood velocity (P = 0.020) and beta stiffness (P = 0.038). In conclusion, manipulation of assessment site local haemodynamics, including the blood velocity profile and local arterial stiffness, had a large effect on estimated cSBP and cAIx, but not on Pb. These findings do not invalidate PWA devices but do suggest that the accuracy of the estimated aortic pressure waveform is dependent on stable peripheral haemodynamics.",2019,"In the control arm, cAIx (ES = 0.22, P = 0.013) but not SBP or cSBP significantly changed.","['20 healthy adults (26.7 years [SD 5.2], 10 F']",[],"['accuracy of central BP waveform estimation', 'blood velocity profile and local arterial stiffness', 'estimated central blood pressure waveforms', 'Pulse wave analysis (PWA) utilizes arm blood pressure (BP) waveforms to estimate aortic waveforms', 'brachial retrograde blood velocity', 'beta stiffness', 'brachial systolic blood velocity', 'brachial BP waveforms', 'central systolic BP (cSBP) and arterial wave reflection (central augmentation index, cAIx; aortic backward pressure wave, Pb']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}]",[],"[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0450448', 'cui_str': 'Waveforms (qualifier value)'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C3494430', 'cui_str': 'Pulse Wave Analysis'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439781', 'cui_str': 'Backward (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",20.0,0.0923054,"In the control arm, cAIx (ES = 0.22, P = 0.013) but not SBP or cSBP significantly changed.","[{'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Stoner', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA. dr.l.stoner@gmail.com.'}, {'ForeName': 'Keeron', 'Initials': 'K', 'LastName': 'Stone', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Gloucester, UK.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Zieff', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'EriK D', 'Initials': 'ED', 'LastName': 'Hanson', 'Affiliation': 'Department of Exercise and Sport Science, University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Credeur', 'Affiliation': 'School of Kinesiology, University of Southern Mississippi, Hattiesburg, MS, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Faulkner', 'Affiliation': 'Department of Sport & Exercise, University of Winchester, Winchester, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kucharska-Newton', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Fryer', 'Affiliation': 'School of Sport and Exercise, University of Gloucestershire, Gloucester, UK.'}]",Journal of human hypertension,['10.1038/s41371-019-0179-x']
229,32302018,Pain Perception and Side Effects During Saline Infusion Sonohysterography With a Balloon Catheter: A Randomized Comparative Study of Cervical Versus Intrauterine Catheter Placement.,"OBJECTIVES


This study aimed to evaluate whether the site of the balloon placement into either the uterine cavity or cervical canal can affect the intensity of pain during sonohysterography.
METHODS


In this randomized clinical trial, women who underwent saline infusion sonohysterography (SIS) were randomized to intracervical or intrauterine balloon placement between May 2012 and May 2014. The examination was scheduled at the early follicular phase of the menstrual cycle. The primary outcome measures included the degree of pain after inflation and then after deflation of the balloon catheter. Data were analyzed on the basis of the intention-to-treat principle for each woman who underwent SIS.
RESULTS


A total of 300 infertile women were assigned to the treatment groups. There were no significant differences in inflation and deflation pain and the total procedure time between the 2 groups. The total volume of required saline for adequate distention of the cavity was significantly lower in the cervical group than the intrauterine group (p = .015). Nulliparous women had insignificantly more pain after the initial inflation of the balloon compared with multiparous women (p = .069). The pain score was not associated with patients' age, the volume of the saline infused, the presence of intrauterine abnormality, and the procedure time.
CONCLUSIONS


Intracervical catheter placement did not reduce pain during or after SIS. However, intracervical balloon insertion requires a less-significant volume of saline compared with intrauterine placement, leading to a reduced risk of intrauterine infection and the spread of malignant endometrial cells into the peritoneal cavity at the time of the procedure.",2020,"The pain score was not associated with patients' age, the volume of the saline infused, the presence of intrauterine abnormality, and the procedure time.
","['300 infertile women', 'Nulliparous women', 'women who underwent saline infusion sonohysterography (SIS']","['Saline Infusion Sonohysterography With a Balloon Catheter', 'intracervical or intrauterine balloon placement', 'Cervical Versus Intrauterine Catheter Placement', 'Intracervical catheter placement']","['total volume of required saline for adequate distention of the cavity', 'Pain Perception and Side Effects', 'pain', 'degree of pain after inflation and then after deflation of the balloon catheter', 'inflation and deflation pain and the total procedure time', 'pain score']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0949051', 'cui_str': 'Saline infusion sonohysterography'}]","[{'cui': 'C0949051', 'cui_str': 'Saline infusion sonohysterography'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}, {'cui': 'C0444978', 'cui_str': 'Intracervical'}, {'cui': 'C0181374', 'cui_str': 'Intrauterine balloon'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0179766', 'cui_str': 'Intrauterine catheter'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021398', 'cui_str': 'Economic Inflation'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",300.0,0.268124,"The pain score was not associated with patients' age, the volume of the saline infused, the presence of intrauterine abnormality, and the procedure time.
","[{'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Ahmadi', 'Affiliation': 'Department of Reproductive Imaging, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, Academic Center for Education, Culture, and Research (ACECR), Tehran, Iran.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Jahangiri', 'Affiliation': 'Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, Academic Center for Education, Culture, and Research (ACECR), Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Zafarani', 'Affiliation': 'Department of Reproductive Imaging, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, Academic Center for Education, Culture, and Research (ACECR), Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Vosough', 'Affiliation': 'Department of Reproductive Imaging, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, Academic Center for Education, Culture, and Research (ACECR), Tehran, Iran.'}]",Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine,['10.1002/jum.15292']
230,32253184,"Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48-week phase IIb, randomised, double-blind, placebo-controlled, dose-ranging study.","OBJECTIVES


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


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


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


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


NCT02963506.",2020,"At week 48, 58.6% and 62.3% of patients receiving bimekizumab 160 and 320 mg throughout the study achieved ASAS40, respectively (NRI); similar ASAS40 response rates were observed in re-randomised patients.","['Adults with AS (fulfilling modified New York criteria', 'patients with active AS', '303 patients', 'patients with active ankylosing spondylitis', 'patients with active ankylosing spondylitis (AS']","['bimekizumab', 'placebo', 'interleukin-17A and interleukin-17F with bimekizumab', 'ASAS40 vs placebo', 'bimekizumab 16 mg, 64 mg or placebo', 'Bimekizumab']","['interleukin (IL)-17A and IL-17F', 'adverse events', 'SpondyloArthritis international Society (ASAS) 40 response', 'efficacy and safety', 'ASAS40 response rates']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038012', 'cui_str': 'Spondylitis'}]","[{'cui': 'C4519734', 'cui_str': 'bimekizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C1432339', 'cui_str': 'IL17F protein, human'}]","[{'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C1432339', 'cui_str': 'IL17F protein, human'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0949690', 'cui_str': 'Arthritis of spine'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",303.0,0.70834,"At week 48, 58.6% and 62.3% of patients receiving bimekizumab 160 and 320 mg throughout the study achieved ASAS40, respectively (NRI); similar ASAS40 response rates were observed in re-randomised patients.","[{'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands mail@dvanderheijde.nl.'}, {'ForeName': 'Lianne S', 'Initials': 'LS', 'LastName': 'Gensler', 'Affiliation': 'University California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Herne, Germany.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Poddubnyy', 'Affiliation': 'Department of Rheumatology, Infectious Diseases and Rheumatology, Charité-Universitätsmedizin Berlin and Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, Pennsylvania, USA.'}, {'ForeName': 'Mary Katherine', 'Initials': 'MK', 'LastName': 'Farmer', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Baeten', 'Affiliation': 'Department of Clinical Immunology and Rheumatology, UCB Pharma, Slough, UK.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Goldammer', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Coarse', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Marga', 'Initials': 'M', 'LastName': 'Oortgiesen', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Department of Rheumatology, Université de Paris, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-216980']
231,31609489,Cleansing efficacy of waist-shaped inter-dental brushes. A randomized-controlled crossover study.,"OBJECTIVE


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


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


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


This study has demonstrated the superiority in cleansing efficacy of waist-shaped over cylindric inter-dental brushes in individuals receiving supportive periodontal treatment.",2020,"There were no statistically significant differences between PBI levels of waist-shaped and cylindric brushes.
","['individuals receiving supportive periodontal treatment', 'Seventeen probands with 1,474 tooth sites finished the study', '20 periodontal maintenance patients diagnosed with periodontitis stage 3 were recruited', 'patients receiving supportive periodontal therapy']","['waist-shaped and cylindric interdental brushes', 'waist-shaped interdental brushes', 'waist-shaped versus cylindric interdental brushes']","['Turesky-Quigley Hein plaque index (T-QHI) and the papillary bleeding index (PBI', 'PBI levels of waist-shaped and cylindric brushes', 'T-QHI for waist-shaped interdental brushes', 'median of overall T-QHI scores']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0702111', 'cui_str': 'Proband (finding)'}, {'cui': 'C0445330', 'cui_str': 'Tooth site (attribute)'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}]","[{'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0442104', 'cui_str': 'Interdental (qualifier value)'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205312', 'cui_str': 'Papillary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0230097', 'cui_str': 'Waist (surface region)'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0442104', 'cui_str': 'Interdental (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.156129,"There were no statistically significant differences between PBI levels of waist-shaped and cylindric brushes.
","[{'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Schnabl', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Goebel', 'Affiliation': 'Department of Medical Statistics, Informatics and Health Economics, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Kadletz', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Gaenzer', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Steiner', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Laimer', 'Affiliation': 'University Hospital of Cranio-Maxillofacial and Oral Surgery, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Kapferer-Seebacher', 'Affiliation': 'Department of Operative and Prosthetic Dentistry, Medical University of Innsbruck, Innsbruck, Austria.'}]",Journal of clinical periodontology,['10.1111/jcpe.13210']
232,31520543,A dual-strain Lactobacilli reuteri probiotic improves the treatment of residual pockets: A randomized controlled clinical trial.,"AIM


To examine the adjunctive effect of a Lactobacillus reuteri probiotic (ATCC PTA 5289 & DSM 17938) on the re-instrumentation of residual pockets.
MATERIALS AND METHODS


This randomized, double-blind, placebo-controlled study included 39 previously non-surgically treated periodontitis patients. A re-instrumentation was carried out, and probiotic and/or placebo drops were applied according to the study protocoll. Patients afterwards received lozenges to use 2×/day for 12 weeks. Probing pocket depth (PPD), recession, bleeding on probing and plaque levels were analysed, next to the microbiological impact.
RESULTS


No effects of the probiotic drops could be found. However, after 24 weeks, the overall PPD in the probiotic lozenges group (2.64 ± 0.33 mm) was significantly lower compared to the control lozenges (2.92 ± 0.42 mm). This difference was even more pronounced in moderate (4-6 mm) and deep (≥7 mm) pockets. In the probiotic lozenges group, there were also significantly more pockets converting from ≥4 mm at baseline to ≤3 mm at 24 weeks (67 ± 18% versus 54 ± 17%) and less sites in need for surgery (4 ± 4% versus 8 ± 6%). However, the probiotic products did not influence the microbiological counts of the periodontopathogens.
CONCLUSION


The adjunctive consumption of L. reuteri lozenges after re-instrumentation improved the PPD reduction, without an impact on pocket colonization with periodontopathogens.",2020,This difference was even more pronounced in moderate (4-6mm) and deep (≥7mm) pockets.,"['39 previously non-surgically treated periodontitis patients', 'residual pockets']","['placebo', 'Lactobacillus reuteri probiotic (ATCC PTA', 'strain Lactobacilli reuteri probiotic']","['microbiological counts', 'Probing pocket depth (PPD), recession, bleeding on probing and plaque levels', 'PPD reduction', 'overall PPD']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]","[{'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",39.0,0.191428,This difference was even more pronounced in moderate (4-6mm) and deep (≥7mm) pockets.,"[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Laleman', 'Affiliation': 'Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Pauwels', 'Affiliation': 'Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Quirynen', 'Affiliation': 'Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Teughels', 'Affiliation': 'Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Leuven, Belgium.'}]",Journal of clinical periodontology,['10.1111/jcpe.13198']
233,30675757,Batroxobin in combination with anticoagulation may promote venous sinus recanalization in cerebral venous thrombosis: A real-world experience.,"AIMS


The objective of this study was to evaluate cerebral venous recanalization with magnetic resonance black-blood thrombus imaging (MRBTI) in patients with cerebral venous thrombosis (CVT) who underwent batroxobin treatment in combination with anticoagulation.
METHODS


A total of 31 CVT patients were enrolled in this real-world registry study. The patients were divided into batroxobin (n = 21) and control groups (n = 10). In addition to the same standard anticoagulation as in the control group, patients in the batroxobin group underwent intravenous batroxobin for a total of three times.
RESULTS


In the batroxobin group compared with the control group, we found better odds of recanalization degree [adjusted OR (95%CI) of 8.10 (1.61-40.7)] and segment-stenosis attenuation [adjusted OR (95%CI) of 4.48 (1.69-11.9)] with batroxobin treatment. We further noted a higher ratio of patients with the attenuation of stenosis [adjusted OR (95%CI) of 26.4 (1.10-635)]; as well as a higher ratio of segments with stenosis reversion [adjusted OR (95%CI) of 4.52 (1.48-13.8)]. However, neurological deficits between the two groups showed no statistical difference at 90-day follow-up (P > 0.05).
CONCLUSIONS


Batroxobin may promote venous sinus recanalization and attenuate CVT-induced stenosis. Further randomized study of this promising drug may be warranted to better delineate the amount of benefit.",2019,"However, neurological deficits between the two groups showed no statistical difference at 90-day follow-up (P > 0.05).
","['patients with cerebral venous thrombosis (CVT) who underwent batroxobin treatment in combination with anticoagulation', 'cerebral venous thrombosis', '31 CVT patients were enrolled in this real-world registry study']","['magnetic resonance black-blood thrombus imaging (MRBTI', 'Batroxobin', 'batroxobin', 'intravenous batroxobin']","['neurological deficits', 'recanalization degree [adjusted OR (95%CI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151945', 'cui_str': 'Thrombosis of cerebral veins (disorder)'}, {'cui': 'C0035158', 'cui_str': 'Defibrol'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0035158', 'cui_str': 'Defibrol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}, {'cui': 'C0034771', 'cui_str': 'Recanalization (morphologic abnormality)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}]",31.0,0.0523931,"However, neurological deficits between the two groups showed no statistical difference at 90-day follow-up (P > 0.05).
","[{'ForeName': 'Jia-Yue', 'Initials': 'JY', 'LastName': 'Ding', 'Affiliation': 'Departments of Neurology and Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Li-Qun', 'Initials': 'LQ', 'LastName': 'Pan', 'Affiliation': 'Departments of Neurology and Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan-Yu', 'Initials': 'YY', 'LastName': 'Hu', 'Affiliation': 'Center of Sleep, Xianyue Hospital, Xiamen, China.'}, {'ForeName': 'Gary B', 'Initials': 'GB', 'LastName': 'Rajah', 'Affiliation': 'Department of Neurosurgery, Wayne State University School of Medicine, Detroit, Michigan.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Departments of Neurology and Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Chao-Bo', 'Initials': 'CB', 'LastName': 'Bai', 'Affiliation': 'Departments of Neurology and Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing-Yuan', 'Initials': 'JY', 'LastName': 'Ya', 'Affiliation': 'Departments of Neurology and Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhong-Ao', 'Initials': 'ZA', 'LastName': 'Wang', 'Affiliation': 'Departments of Neurology and Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ke-Xin', 'Initials': 'KX', 'LastName': 'Jin', 'Affiliation': 'Departments of Neurology and Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing-Wei', 'Initials': 'JW', 'LastName': 'Guan', 'Affiliation': 'Departments of Neurology and Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yu-Chuan', 'Initials': 'YC', 'LastName': 'Ding', 'Affiliation': 'Center of Stroke, Beijing Institute for Brain Disorders, Beijing, China.'}, {'ForeName': 'Xun-Ming', 'Initials': 'XM', 'LastName': 'Ji', 'Affiliation': 'Departments of Neurology and Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Meng', 'Affiliation': 'Departments of Neurology and Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.'}]",CNS neuroscience & therapeutics,['10.1111/cns.13093']
234,30958141,Stress reduction intervention with mothers of children/adolescents with asthma: a randomized controlled study in Brazil.,"Brazil has a high prevalence of pediatric asthma, which can be a stressor to parents/caretakers. Researchers aimed to assesses the efficacy of a stress reduction intervention for mothers of children/adolescents with asthma through a randomized controlled study. Stress, anxiety, and depression were evaluated in three moments. The intervention group ( n  = 20), entailed 5-weekly sessions; the control group ( n  =34) had waiting list format. There was a significant decrease in stress, anxiety, and depression in the intervention group. This study indicates that the intervention directed to mothers of children/adolescents with asthma was efficient not only in reducing stress but also anxiety and depression reduction.",2020,"There was a significant decrease in stress, anxiety, and depression in the intervention group.",['mothers of children/adolescents with asthma'],"['Brazil', 'Stress reduction intervention', 'waiting list format', 'stress reduction intervention']","['Stress, anxiety, and depression', 'stress, anxiety, and depression']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]","[{'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C1301627', 'cui_str': 'Format'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.0193105,"There was a significant decrease in stress, anxiety, and depression in the intervention group.","[{'ForeName': 'Sandra Cairo de Oliveira', 'Initials': 'SCO', 'LastName': 'Amaral', 'Affiliation': 'Medical Clinic, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Filipa', 'Initials': 'F', 'LastName': 'Pimenta', 'Affiliation': 'ISPA - Instituto Universitário/WJCR - William James Center for Research, Lisbon, Portugal.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Marôco', 'Affiliation': 'ISPA - Instituto Universitário/WJCR - William James Center for Research, Lisbon, Portugal.'}, {'ForeName': 'Clemax Couto', 'Initials': 'CC', 'LastName': ""Sant'Anna"", 'Affiliation': 'Medical Clinic, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}]",Health care for women international,['10.1080/07399332.2019.1570201']
235,31136879,The effect of increasing state anxiety on autobiographical memory specificity and future thinking.,"BACKGROUND AND OBJECTIVES


Impairments in the specificity of autobiographical memory (AM) and future thinking are associated with a range of affective and psychopathological states, however, whether these deficits also occur in the context of state anxiety is not well known. We examined the effects of increasing state anxiety on the specificity of AM and future thoughts, as well as whether changes in rumination and executive functioning mediate any observed effects.
METHODS


Sixty-four participants (M age = 29.1, SD = 11.5) were randomized to either an anxiety or neutral mood induction and completed pre and post-measures of the constructs of interest.
RESULTS


There were significant decreases observed in AM specificity in the anxiety induction group, relative to the neutral group. No changes were observed for future thinking specificity. Rumination was increased as a result of the anxiety induction, but only a non-significant trend was observed with respect to its association with changes in AM and future thinking specificity. Verbal fluency and working memory were not affected by the induction.
LIMITATIONS


Physiological measures of anxiety were not used. State anxiety, although increased, was not high in severity. Future research might use a clinical sample to assess generalizability of these findings.
CONCLUSIONS


Although preliminary, these findings provide first evidence of the causal impact of an anxiety induction on the ability to retrieve specific AM.",2019,No changes were observed for future thinking specificity.,"['Sixty-four participants (M age\u202f=\u202f29.1, SD\u202f=\u202f11.5']",['anxiety or neutral mood induction'],"['Verbal fluency and working memory', 'Rumination', 'State anxiety', 'AM specificity', 'anxiety induction']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]","[{'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}]",64.0,0.018712,No changes were observed for future thinking specificity.,"[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Hallford', 'Affiliation': 'School of Psychology, Deakin University, 1 Gheringhap Road, Geelong, Victoria, 3220, Australia. Electronic address: david.hallford@deakin.edu.au.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Mellor', 'Affiliation': 'School of Psychology, Deakin University, 1 Gheringhap Road, Geelong, Victoria, 3220, Australia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bafit', 'Affiliation': 'School of Psychology, Deakin University, 1 Gheringhap Road, Geelong, Victoria, 3220, Australia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Devenish', 'Affiliation': 'School of Psychology, Deakin University, 1 Gheringhap Road, Geelong, Victoria, 3220, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bogeski', 'Affiliation': 'School of Psychology, Deakin University, 1 Gheringhap Road, Geelong, Victoria, 3220, Australia.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Austin', 'Affiliation': 'School of Psychology, Deakin University, 1 Gheringhap Road, Geelong, Victoria, 3220, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'Brain and Psychological Sciences Research Centre, Swinburne University, Mail H99. PO Box 218, Hawthorn, VIC, 3122, Australia.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101488']
236,32293514,Addressing identification bias in the design and analysis of cluster-randomized pragmatic trials: a case study.,"BACKGROUND


Pragmatic trials provide the opportunity to study the effectiveness of health interventions to improve care in real-world settings. However, use of open-cohort designs with patients becoming eligible after randomization and reliance on electronic health records (EHRs) to identify participants may lead to a form of selection bias referred to as identification bias. This bias can occur when individuals identified as a result of the treatment group assignment are included in analyses.
METHODS


To demonstrate the importance of identification bias and how it can be addressed, we consider a motivating case study, the PRimary care Opioid Use Disorders treatment (PROUD) Trial. PROUD is an ongoing pragmatic, cluster-randomized implementation trial in six health systems to evaluate a program for increasing medication treatment of opioid use disorders (OUDs). A main study objective is to evaluate whether the PROUD intervention decreases acute care utilization among patients with OUD (effectiveness aim). Identification bias is a particular concern, because OUD is underdiagnosed in the EHR at baseline, and because the intervention is expected to increase OUD diagnosis among current patients and attract new patients with OUD to the intervention site. We propose a framework for addressing this source of bias in the statistical design and analysis.
RESULTS


The statistical design sought to balance the competing goals of fully capturing intervention effects and mitigating identification bias, while maximizing power. For the primary analysis of the effectiveness aim, identification bias was avoided by defining the study sample using pre-randomization data (pre-trial modeling demonstrated that the optimal approach was to use individuals with a prior OUD diagnosis). To expand generalizability of study findings, secondary analyses were planned that also included patients newly diagnosed post-randomization, with analytic methods to account for identification bias.
CONCLUSION


As more studies seek to leverage existing data sources, such as EHRs, to make clinical trials more affordable and generalizable and to apply novel open-cohort study designs, the potential for identification bias is likely to become increasingly common. This case study highlights how this bias can be addressed in the statistical study design and analysis.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03407638. Registered on 23 January 2018.",2020,"To demonstrate the importance of identification bias and how it can be addressed, we consider a motivating case study, the PRimary care Opioid Use Disorders treatment (PROUD) Trial.",['patients with OUD (effectiveness aim'],"['health interventions', 'PROUD intervention']",['OUD diagnosis'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.080277,"To demonstrate the importance of identification bias and how it can be addressed, we consider a motivating case study, the PRimary care Opioid Use Disorders treatment (PROUD) Trial.","[{'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Bobb', 'Affiliation': 'Biostatistics Unit, Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA, 98101, USA. Jennifer.F.Bobb@kp.org.'}, {'ForeName': 'Hongxiang', 'Initials': 'H', 'LastName': 'Qiu', 'Affiliation': 'Department of Biostatistics, University of Washington, 1705 NE Pacific St, Seattle, WA, 98195, USA.'}, {'ForeName': 'Abigail G', 'Initials': 'AG', 'LastName': 'Matthews', 'Affiliation': 'The Emmes Company, 401 N Washington St # 700, Rockville, MD, 20850, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McCormack', 'Affiliation': 'The Emmes Company, 401 N Washington St # 700, Rockville, MD, 20850, USA.'}, {'ForeName': 'Katharine A', 'Initials': 'KA', 'LastName': 'Bradley', 'Affiliation': 'Biostatistics Unit, Kaiser Permanente Washington Health Research Institute, 1730 Minor Ave, Seattle, WA, 98101, USA.'}]",Trials,['10.1186/s13063-020-4148-z']
237,31513552,"Project Shikamana: Community Empowerment-Based Combination HIV Prevention Significantly Impacts HIV Incidence and Care Continuum Outcomes Among Female Sex Workers in Iringa, Tanzania.","OBJECTIVE


To determine the impact of a community empowerment model of combination HIV prevention (Project Shikamana) among female sex workers (FSW) in Iringa, Tanzania.
METHODS


We conducted a 2-community randomized trial. Intervention elements included the following: (1) Community-led drop-in center and mobilization activities; (2) venue-based peer education, condom distribution, and HIV testing; (3) peer service navigation; (4) provider sensitivity trainings; and (5) SMS reminders. We used time-location sampling to enroll 496 FSW and conducted a survey and blood draws to screen for HIV and assess viral load at 0 and 18 months. We conducted an intent-to-treat analysis using logistic and Poisson regression and inverse probability weighting for primary outcomes.
RESULTS


The analysis included 171 HIV-positive and 216 HIV-negative FSW who completed baseline and 18-month study visits. Participants in the intervention were significantly less likely to become infected with HIV at 18-month follow-up (RR 0.38; P = 0.047), with an HIV incidence of 5.0% in the intervention vs. 10.4% control. Decreases in inconsistent condom use over time were significantly greater in the intervention (72.0%-43.6%) vs. control (68.8%-54.0%; RR 0.81, P = 0.042). At follow-up, we observed significant differences in behavioral HIV care continuum outcomes, and positive, but nonsignificant, increases in viral suppression (40.0%-50.6%) in the intervention vs. control (35.9%-47.4%). There was a strong association of between higher intervention exposure and HIV outcomes including viral suppression.
CONCLUSIONS


Project Shikamana is the first trial of community empowerment-based combination prevention among FSW in Africa to show a significant reduction in HIV incidence warranting its broader implementation and evaluation.",2019,"Decreases in inconsistent condom use over time were significantly greater in the intervention (72.0%-43.6%) vs. control (68.8%-54.0%; RR 0.81, P = 0.042).","['female sex workers (FSW) in Iringa, Tanzania', '171 HIV-positive and 216 HIV-negative FSW who completed baseline and 18-month study visits', 'Female Sex Workers in Iringa, Tanzania']","['Community-led drop-in center and mobilization activities; (2) venue-based peer education, condom distribution, and HIV testing; (3) peer service navigation; (4) provider sensitivity trainings; and (5) SMS reminders', 'community empowerment model of combination HIV prevention (Project Shikamana']","['viral suppression', 'behavioral HIV care continuum outcomes', 'HIV incidence']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0240816', 'cui_str': 'Prostitutes'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0700628', 'cui_str': 'Sensitivity training'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0009853', 'cui_str': 'Continuity of Care'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",171.0,0.10898,"Decreases in inconsistent condom use over time were significantly greater in the intervention (72.0%-43.6%) vs. control (68.8%-54.0%; RR 0.81, P = 0.042).","[{'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Kerrigan', 'Affiliation': 'Department of Sociology, Center on Health, Risk and Society, American University, Washington, DC.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Mbwambo', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Likindikoki', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Davis', 'Affiliation': 'Department of Sociology, Center on Health, Risk and Society, American University, Washington, DC.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mantsios', 'Affiliation': 'Department of Sociology, Center on Health, Risk and Society, American University, Washington, DC.'}, {'ForeName': 'S Wilson', 'Initials': 'SW', 'LastName': 'Beckham', 'Affiliation': 'Department of Health, Behavior and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Leddy', 'Affiliation': 'Department of Medicine, University of California at San Francisco, San Francisco, CA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Shembilu', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Ard', 'Initials': 'A', 'LastName': 'Mwampashi', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': 'Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Noya', 'Initials': 'N', 'LastName': 'Galai', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002123']
238,31576424,Effects of transcranial random noise stimulation combined with Graded Repetitive Arm Supplementary Program (GRASP) on motor rehabilitation of the upper limb in sub-acute ischemic stroke patients: a randomized pilot study.,"We evaluated the combined use of transcranial random noise stimulation (tRNS) with the Graded Repetitive Arm Supplementary Program (GRASP) in sub-acute ischemic stroke patients suffering from arm impairment. Eighteen ischemic stroke patients with upper limb disability were randomly assigned to either the GRASP + tRNS or GRASP + Sham stimulation group. Fugl-Meyer Assessment-Upper extremity (FMA-UE) was performed to evaluate upper limb impairment before treatment (T0), after the last stimulation (T1) and after 30 days (T2). At T1 and T2, beneficial effects in the tRNS group correlated with better FMA-UE score than sham stimulation group (p < 0.001) and these results did not correlate to stroke severity, because no associations were observed between National Institute of Health Stroke Scale and FMA UE T1 and T2. This study displayed a good feasibility and was the first to evaluate the use of tRNS in association with Grasp in sub-acute stroke survivors having arm impairment to improve arm motor recovery.",2019,Eighteen ischemic stroke patients with upper limb disability were randomly assigned to either the GRASP + tRNS or GRASP + Sham stimulation group.,"['Eighteen ischemic stroke patients with upper limb disability', 'sub-acute ischemic stroke patients suffering from arm impairment', 'sub-acute ischemic stroke patients']","['GRASP\u2009+\u2009tRNS or GRASP\u2009+\u2009Sham stimulation group', 'transcranial random noise stimulation (tRNS) with the Graded Repetitive Arm Supplementary Program (GRASP', 'Fugl-Meyer Assessment-Upper extremity (FMA-UE', 'tRNS', 'transcranial random noise stimulation combined with Graded Repetitive Arm Supplementary Program (GRASP']","['FMA-UE score', 'National Institute of Health Stroke Scale and FMA UE T1 and T2']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]","[{'cui': 'C0220843', 'cui_str': 'Grip'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3472496', 'cui_str': 'National Institutes of Health stroke scale'}]",18.0,0.0451837,Eighteen ischemic stroke patients with upper limb disability were randomly assigned to either the GRASP + tRNS or GRASP + Sham stimulation group.,"[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Arnao', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D), University of Palermo, Via Gaetano La Loggia n.1, 90129, Palermo, Italy.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Riolo', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D), University of Palermo, Via Gaetano La Loggia n.1, 90129, Palermo, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Carduccio', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D), University of Palermo, Via Gaetano La Loggia n.1, 90129, Palermo, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Tuttolomondo', 'Affiliation': 'Dipartimento Biomedico di Medicina Interna e Specialistica (Di.Bi.M.I.S), Università degli Studi di Palermo, Via del Vespro 129, 90127, Palermo, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': ""D'Amelio"", 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D), University of Palermo, Via Gaetano La Loggia n.1, 90129, Palermo, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Brighina', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D), University of Palermo, Via Gaetano La Loggia n.1, 90129, Palermo, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Gangitano', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D), University of Palermo, Via Gaetano La Loggia n.1, 90129, Palermo, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Salemi', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D), University of Palermo, Via Gaetano La Loggia n.1, 90129, Palermo, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ragonese', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D), University of Palermo, Via Gaetano La Loggia n.1, 90129, Palermo, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Aridon', 'Affiliation': 'Department of Biomedicine, Neuroscience and Advanced Diagnostics (Bi.N.D), University of Palermo, Via Gaetano La Loggia n.1, 90129, Palermo, Italy. paolo.aridon@unipa.it.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-019-02087-9']
239,31132511,Transdiagnostic cognitive behavioral therapy for the treatment of emotional disorders: A preliminary open trial.,"BACKGROUND AND OBJECTIVES


To assess the efficacy of a transdiagnostic cognitive behavioral therapy (tCBT) protocol for the treatment of emotional disorders with individuals that have a principal or comorbid depressive diagnosis.
METHODS


Treatment-seeking adults meeting diagnostic criteria for a depressive disorder were enrolled in a 12-week tCBT open trial aimed at addressing the underlying core pathology of emotional disorders. Clinician severity ratings (CSRs) regarding principal and comorbid diagnoses, and overall severity as well as clinical global impression-severity (CGI-S) ratings were assessed at pre- and post-treatment and 4-month follow-up. Clinician's provided a clinical global impression-improvement (CGI-I) rating post-treatment and at 4-month follow-up. Depressive and anxiety symptoms were measured at pre-treatment and session-by-session using self-report measures (BDI-II and ADDQ).
RESULTS


Repeated measure ANOVAs indicated a reduction in principal diagnosis severity, overall severity, and CGI-S with large effects observed post-treatment (Cohen's ds = 1.29-1.92) and at 4-month follow-up (Cohen's ds = 0.77-1.04). Mixed-effect regression modelling demonstrated a decrease in depressive and anxiety symptoms over the course of treatment. CGI-I ratings identified 63.64% participants as treatment responders both post-treatment and at 4-month follow-up.
LIMITATIONS


The uncontrolled nature of the trial and small sample size are the main limitations to generalizability of the findings.
CONCLUSIONS


The findings, although preliminary, provide additional evidence for the utilization of tCBT in the effective treatment of emotional disorders. Further research into the implementation of the tCBT for emotional disorders protocol through a randomized controlled trial involving groups of participants with a range of emotional disorder diagnoses is warranted.",2019,"CGI-I ratings identified 63.64% participants as treatment responders both post-treatment and at 4-month follow-up.
","['participants with a range of emotional disorder diagnoses', 'emotional disorders with individuals that have a principal or comorbid depressive diagnosis', 'emotional disorders', 'Treatment-seeking adults meeting diagnostic criteria for a depressive disorder']","['transdiagnostic cognitive behavioral therapy (tCBT) protocol', 'tCBT', 'Transdiagnostic cognitive behavioral therapy']","['principal diagnosis severity, overall severity, and CGI-S', 'Clinician severity ratings (CSRs) regarding principal and comorbid diagnoses, and overall severity as well as clinical global impression-severity (CGI-S) ratings', 'Depressive and anxiety symptoms', 'depressive and anxiety symptoms']","[{'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0401925', 'cui_str': 'Teaching principal (occupation)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0332137', 'cui_str': 'Principal diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0401925', 'cui_str': 'Teaching principal (occupation)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",,0.0464929,"CGI-I ratings identified 63.64% participants as treatment responders both post-treatment and at 4-month follow-up.
","[{'ForeName': 'Kelly R', 'Initials': 'KR', 'LastName': 'Harris', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Norton', 'Affiliation': 'Monash University, Australia. Electronic address: peter.norton@monash.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101487']
240,31176067,Imagery rescripting of early memories in health anxiety disorder: A feasibility and non-randomized pilot study.,"BACKGROUND AND OBJECTIVES


Health anxiety is a common problem and is associated with frequent primary care visits, increased health care costs, and poor prognosis and low recovery rates. Previous research shows that imagery rescripting (IR) is a promising treatment technique for various disorders. To date, IR has not been examined as a viable treatment for health anxiety. The purpose of the present feasibility and pilot study was to test one session of IR of early anxiety-laden health-related memories in a small sample of patients suffering from HA.
METHODS


A within-groups design was used with a sample of 18 patients suffering from HA, who first underwent a control condition (reading about CBT), and then one week later a session of IR. After another week, the effects were measured on self-reported health anxiety and early anxiety provoking health-related mental images (memories).
RESULTS


After the IR intervention, significant reductions of health anxiety and health worry, as well as image and memory distress, vividness and frequency were observed.
LIMITATIONS


Among the most important limitations are the absence of an active control group, the small size of the sample, the absence of a longer follow-up, and the use of only self-report measures.
CONCLUSIONS


The results suggest that IR is a feasible technique in the treatment of health anxiety, and that more controlled research along these lines may be worthwhile.",2019,"After the IR intervention, significant reductions of health anxiety and health worry, as well as image and memory distress, vividness and frequency were observed.
","['18 patients suffering from HA, who first underwent a control condition (reading about CBT), and then one week later a session of IR', 'health anxiety disorder', 'patients suffering from HA']",['Imagery rescripting of early memories'],"['health anxiety and health worry, as well as image and memory distress, vividness and frequency', 'health anxiety and early anxiety provoking health-related mental images (memories']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",18.0,0.0221055,"After the IR intervention, significant reductions of health anxiety and health worry, as well as image and memory distress, vividness and frequency were observed.
","[{'ForeName': 'Jan-Erik', 'Initials': 'JE', 'LastName': 'Nilsson', 'Affiliation': 'Kognio, Centre for Cognitive and Behavioral Therapies, Lund, Sweden. Electronic address: jan-erik.nilsson@kognio.se.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Knutsson', 'Affiliation': 'Department of Psychology, Lund University, Sweden.'}, {'ForeName': 'Björn-Sindre', 'Initials': 'BS', 'LastName': 'Jalamo', 'Affiliation': 'Primary Care Health Center, Capio City Clinic, Helsingborg, Sweden.'}, {'ForeName': 'Lars-Gunnar', 'Initials': 'LG', 'LastName': 'Lundh', 'Affiliation': 'Department of Psychology, Lund University, Sweden.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101491']
241,31650286,Theta burst stimulation for the treatment of obsessive-compulsive disorder: a pilot study.,"A non-negligible part of patients with obsessive-compulsive disorder (OCD) experiences inadequate response to pharmacological and cognitive therapies. Therefore, new approaches are required to overcome this problem. The present pilot study estimates the capacity of theta burst stimulation (TBS) in reducing OCD symptoms, also focusing on the neurophysiological basis of TBS aftereffects. Ten patients with OCD who were unsatisfactorily responsive to the pharmacological and neuropsychological treatment, participated to the present randomized crossover pilot study, in which they were subjected to a real or sham intermittent TBS (iTBS) paradigm over the left dorsolateral prefrontal cortex (L-DLPFC) as add-on treatment. They were randomly assigned to a real or sham iTBS in a 1:1 allocation ratio. Patients received the TBS treatment every morning, 5 days a week for 1 month, and were clinically and electrophysiologically evaluated (EEG phase synchronization and coherence) before, immediately after (T0), and one (T1), three (T3) and six (T6) months after the end of the TBS treatment. Then, each patient was subjected to the alternative treatment (that was not practiced before), and followed up to 6 months. We found that all the patients improved in OCD symptomatology up to T1, while four among them improved up to T3. These patients were those showing a more extensive reshape of frontal areas phase synchronization and frontoparietal coherence compared to the other participants. Our pilot study suggests that iTBS over L-DLPFC may represent a feasible approach to improve OCD symptoms. The efficacy of iTBS seems to depend on the extent of frontal and frontoparietal connectivity modulation.",2019,These patients were those showing a more extensive reshape of frontal areas phase synchronization and frontoparietal coherence compared to the other participants.,"['obsessive-compulsive disorder', 'Ten patients with OCD who were unsatisfactorily responsive to the pharmacological and neuropsychological treatment', 'patients with obsessive-compulsive disorder (OCD']","['theta burst stimulation (TBS', 'Theta burst stimulation', 'TBS', 'real or sham iTBS', 'real or sham intermittent TBS (iTBS) paradigm', 'iTBS']","['OCD symptoms', 'extensive reshape of frontal areas phase synchronization and frontoparietal coherence', 'OCD symptomatology']","[{'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]",,0.0199013,These patients were those showing a more extensive reshape of frontal areas phase synchronization and frontoparietal coherence compared to the other participants.,"[{'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Naro', 'Affiliation': 'IRCCS Centro Neurolesi Bonino Pulejo, SS113, via Palermo, C.da Casazza, 98124, Messina, Italy.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Billeri', 'Affiliation': 'IRCCS Centro Neurolesi Bonino Pulejo, SS113, via Palermo, C.da Casazza, 98124, Messina, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Cannavò', 'Affiliation': 'IRCCS Centro Neurolesi Bonino Pulejo, SS113, via Palermo, C.da Casazza, 98124, Messina, Italy.'}, {'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'De Luca', 'Affiliation': 'IRCCS Centro Neurolesi Bonino Pulejo, SS113, via Palermo, C.da Casazza, 98124, Messina, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Portaro', 'Affiliation': 'IRCCS Centro Neurolesi Bonino Pulejo, SS113, via Palermo, C.da Casazza, 98124, Messina, Italy.'}, {'ForeName': 'Placido', 'Initials': 'P', 'LastName': 'Bramanti', 'Affiliation': 'IRCCS Centro Neurolesi Bonino Pulejo, SS113, via Palermo, C.da Casazza, 98124, Messina, Italy.'}, {'ForeName': 'Rocco Salvatore', 'Initials': 'RS', 'LastName': 'Calabrò', 'Affiliation': 'IRCCS Centro Neurolesi Bonino Pulejo, SS113, via Palermo, C.da Casazza, 98124, Messina, Italy. salbro77@tiscali.it.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-019-02098-6']
242,31170623,Niacin biological challenge: A paradigm to evaluate social concerns.,"BACKGROUND AND OBJECTIVES


Anxiety sensitivity (AS) social concerns, the fear of observable anxiety symptoms is posited as a risk factor for social anxiety by increasing fear reactivity in social situations when observable anxiety symptoms are present. Experimental evaluation of AS social concerns is limited. The current study utilized several manipulations designed to be relevant to AS social concerns or fear of negative evaluation (FNE), a distinct social anxiety risk factor. The effects of these manipulations on fear reactivity to a speech were examined.
METHODS


Participants (N = 124 students; M age = 19.44, SD = 2.45; 64.5% female) were randomized to one of four conditions in a 2 (100 mg niacin vs 100 mg sugar pill) X 2 (instructional set) design. For the instructional set manipulation, participants were told their speech performance would be evaluated by a judge based on their performance (i.e., FNE-relevant) or their observable anxiety symptoms (i.e., AS social concerns-relevant).
RESULTS


There was a main effect for vitamin condition with participants in the niacin condition reporting higher panic symptoms post-speech relative to those in the placebo condition. There was no main effect for speech instructions. As hypothesized, these effects were qualified by an interaction indicating that AS social concerns significantly predicted panic symptoms for those receiving niacin.
LIMITATIONS


Limitations include the reliance on self-reports of outcome variables and the use of an undergraduate student sample.
CONCLUSIONS


These findings highlight a distinct role of AS social concerns in fear responding to socially evaluative situations in the context of physically observable arousal.",2019,There was a main effect for vitamin condition with participants in the niacin condition reporting higher panic symptoms post-speech relative to those in the placebo condition.,"['Participants (N\u202f=\u202f124 students; M age\u202f=\u202f19.44, SD\u202f=\u202f2.45; 64.5% female', 'undergraduate student sample']",['niacin'],['panic symptoms'],"[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0027996', 'cui_str': 'Niacin'}]","[{'cui': 'C0030318', 'cui_str': 'Panic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",124.0,0.0174705,There was a main effect for vitamin condition with participants in the niacin condition reporting higher panic symptoms post-speech relative to those in the placebo condition.,"[{'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Allan', 'Affiliation': 'Department of Psychology, Ohio University, Athens, OH, 45701, USA. Electronic address: allan@ohio.edu.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Saulnier', 'Affiliation': 'Department of Psychology, Ohio University, Athens, OH, 45701, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychology, Ohio University, Athens, OH, 45701, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Oglesby', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee, FL, 32306, USA.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee, FL, 32306, USA.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101489']
243,32161055,Initial combination therapy of ambrisentan and tadalafil in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) in the modified intention-to-treat population of the AMBITION study: post hoc analysis.,"OBJECTIVES


To evaluate initial combination therapy with ambrisentan plus tadalafil (COMB) compared with monotherapy of either agent (MONO), and the utility of baseline characteristics and risk stratification in predicting outcomes, in patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) and the systemic sclerosis (SSc)-pulmonary arterial hypertension (PAH) subpopulation.
METHODS


This post hoc analysis of the Ambrisentan and Tadalafil in Patients with Pulmonary Arterial Hypertension (AMBITION) study included patients with CTD-PAH from the modified intention-to-treat population. Time to clinical failure (TtCF) was assessed by baseline characteristics, treatment assignment and risk group (low, intermediate and high) at baseline and week 16. TtCF was compared between groups using Kaplan-Meier curves and Cox proportional hazards regression modelling.
RESULTS


The analysis included 216 patients (COMB, n=117; MONO, n=99). The risk of clinical failure was lower with COMB versus MONO (risk reduction: CTD-PAH 51.7%, SSc-PAH 53.7%), particularly in patients with haemodynamic parameters characteristic of typical PAH without features of left heart disease and/or restrictive lung disease at baseline. The risk of clinical failure was lower with COMB versus MONO in the baseline low-risk group (HR not calculated due to no events in COMB), baseline intermediate-risk group (HR 0.519, 95% CI 0.297 to 0.905) and in the week 16 low-risk group (HR 0.069, 95% CI 0.009 to 0.548).
CONCLUSIONS


The benefit of COMB over MONO was demonstrated in patients with CTD-PAH, particularly in those with typical PAH haemodynamic characteristics at baseline. COMB is appropriate for patients categorised as low risk and intermediate risk at baseline and low risk at follow-up.
TRIAL REGISTRATION NUMBER


NCT01178073.",2020,"The risk of clinical failure was lower with COMB versus MONO (risk reduction: CTD-PAH 51.7%, SSc-PAH 53.7%), particularly in patients with haemodynamic parameters characteristic of typical PAH without features of left heart disease and/or restrictive lung disease at baseline.","['Patients with Pulmonary Arterial Hypertension (AMBITION) study included patients with CTD-PAH from the modified intention-to-treat population', 'connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH', '216 patients (COMB, n=117; MONO, n=99', 'patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) and the systemic sclerosis (SSc)-pulmonary arterial hypertension (PAH) subpopulation']","['ambrisentan plus tadalafil (COMB', 'monotherapy of either agent (MONO', 'ambrisentan and tadalafil', 'TtCF', 'Ambrisentan and Tadalafil']","['risk of clinical failure', 'Time to clinical failure (TtCF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary hypertensive arterial disease (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0009782', 'cui_str': 'Connective Tissue Diseases'}, {'cui': 'C1701938', 'cui_str': 'Associated pulmonary arterial hypertension (disorder)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C3854046', 'cui_str': 'Comb'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0854255', 'cui_str': 'Systemic sclerosis pulmonary'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C1176329', 'cui_str': 'ambrisentan'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C3854046', 'cui_str': 'Comb'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",216.0,0.134752,"The risk of clinical failure was lower with COMB versus MONO (risk reduction: CTD-PAH 51.7%, SSc-PAH 53.7%), particularly in patients with haemodynamic parameters characteristic of typical PAH without features of left heart disease and/or restrictive lung disease at baseline.","[{'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Kuwana', 'Affiliation': 'Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan kuwanam@nms.ac.jp.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Blair', 'Affiliation': 'Research and Development, Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Tomohiko', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Medical Affairs, GlaxoSmithKline Plc, Tokyo, Japan.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Langley', 'Affiliation': 'Medical Affairs, GlaxoSmithKline Plc, Brentford, London, UK.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Coghlan', 'Affiliation': 'Cardiology Services, Royal Free Hospital, London, UK.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216274']
244,32202035,A randomised trial of caesarean wound coverage: exposed versus dressed.,"OBJECTIVE


To evaluate the superficial surgical site infection (SSI) rate to 28 days and patient satisfaction with wound coverage management when their transverse suprapubic caesarean wound is left exposed compared with dressed after skin closure.
DESIGN


Randomised trial.
SETTING


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


331 women delivered by caesarean section.
METHOD


Participants were randomised to leaving their wound entirely exposed (n = 165) or dressed (n = 166) with a low adhesive dressing (next day removal).
MAIN OUTCOME MEASURES


Primary outcomes were superficial SSI rate (assessed by provider inspection up to hospital discharge and telephone questionnaires on days 14 and 28) and patient satisfaction with wound coverage management before hospital discharge.
RESULTS


The superficial SSI rates were 2/153 (1.3%) versus 5/157 (3.2%) (relative risk [RR] 0.4, 95% CI 0.1-2.1; P = 0.45) and patient satisfaction with wound management was 7 [5-8] versus 7 [5-8] (P = 0.81) in exposed compared with dressed study groups, respectively. In the wound-exposed patients, stated preference for wound exposure significantly increased from 35.5 to 57.5%, whereas in the wound-dressed patients, the stated preference for a dressed wound fell from 48.5 to 34.4% when assessed at recruitment (pre-randomisation) to day 28. There were no significant differences in inpatient additional dressing or gauze use for wound care, post-hospital discharge self-reported wound issues of infection, antibiotics, redness and inflammation, swollen, painful, and fluid leakage to day 28 across trial groups.
CONCLUSION


The trial is underpowered as SSI rates were lower than expected. Nevertheless, leaving caesarean wounds exposed does not appear to have detrimental effects, provided patient counselling to manage expectations is undertaken.
TWEETABLE ABSTRACT


An exposed compared with a dressed caesarean wound has a similar superficial surgical site infection rate, patient satisfaction and appearance.",2020,"There were no significant differences in inpatient additional dressing or gauze use for wound care, post-hospital discharge self-reported wound issues of infection, antibiotics, redness and inflammation, swollen, painful, and fluid leakage to Day 28 across trial arms.
","['University Hospital, Malaysia: April 2016-October', '2016 POPULATION: 331 women delivered by Caesarean section METHOD']",['caesarean wound coverage'],"['inpatient additional dressing or gauze use for wound care, post-hospital discharge self-reported wound issues of infection, antibiotics, redness and inflammation, swollen, painful, and fluid leakage', 'SSI rates', 'patient satisfaction with wound management', 'stated preference for wound exposure', 'superficial SSI rate (assessed by provider inspection up to hospital discharge and telephone questionnaires on Day 14 and 28) and patient satisfaction with wound coverage management before hospital discharge RESULTS: The superficial SSI rates']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0021501', 'cui_str': 'wounds'}]","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C0590323', 'cui_str': 'Gauzes (physical object)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0886052', 'cui_str': 'Administers care to wound sites'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0199219', 'cui_str': 'Visual observation'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.190025,"There were no significant differences in inpatient additional dressing or gauze use for wound care, post-hospital discharge self-reported wound issues of infection, antibiotics, redness and inflammation, swollen, painful, and fluid leakage to Day 28 across trial arms.
","[{'ForeName': 'P C', 'Initials': 'PC', 'LastName': 'Tan', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rohani', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'McK', 'Initials': 'M', 'LastName': 'Lim', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Win', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'S Z', 'Initials': 'SZ', 'LastName': 'Omar', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16228']
245,31691408,Preventing sleep deficit in adolescents: Long-term effects of a quasi-experimental school-based intervention study.,"Adolescents are at risk of sleep deficit, which has serious consequences for their daytime functioning. However, school-based interventions to improve sleep have shown limited success. This might be due to the content of the programmes (e.g., not targeting central factors such as daytime stress and technology use) or because changes have not been captured due to a lack of long-term follow-ups. Hence, the aim of this study was to evaluate the long-term effects of a school-based sleep education curriculum including time-management training. The study used a quasi-experimental design. Participants were 3,622 adolescents (mean age 13.7, 48% girls); 286 were in the intervention group and 3,336 were followed as a natural control group. Data were collected before the intervention and at a 1-year follow-up. We divided participants into three groups according to baseline sleep duration (calculated from self-reported bed- and wake times, minus sleep onset latency): insufficient (<7 hr), borderline (7-8 hr) and adequate (>8 hr). Adolescents in the intervention group were ~2 times less likely to report insufficient sleep at follow-up as compared to controls. Sleep knowledge improved significantly in the intervention group but there were no changes in emotional sleep hygiene (e.g., bedtime worry) and perceived stress. Surprisingly, technology use increased and behavioural sleep hygiene worsened in the intervention group. Although the mechanisms of change need further investigation, the results of this study point to potential long-term benefits of school-based sleep programmes.",2020,Adolescents in the intervention group were ~2 times less likely to report insufficient sleep at follow-up as compared to controls.,"['Participants were 3,622 adolescents (mean age 13.7, 48% girls); 286 were in the intervention group and 3,336 were followed as a natural control group', 'adolescents', 'divided participants into three groups according to baseline sleep duration (calculated from self-reported bed- and wake times, minus sleep onset latency): insufficient (<7\xa0hr), borderline (7-8\xa0hr) and adequate (>8\xa0hr']",['school-based sleep education curriculum'],"['emotional sleep hygiene (e.g., bedtime worry) and perceived stress', 'sleep deficit', 'behavioural sleep hygiene', 'Sleep knowledge', 'times less likely to report insufficient sleep']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C4277672', 'cui_str': 'Sleep Hygiene'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0037316', 'cui_str': 'Sleep Deprivation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}]",286.0,0.0168591,Adolescents in the intervention group were ~2 times less likely to report insufficient sleep at follow-up as compared to controls.,"[{'ForeName': 'Serena Valeria', 'Initials': 'SV', 'LastName': 'Bauducco', 'Affiliation': 'Örebro University, Örebro, Sweden.'}, {'ForeName': 'Ida K', 'Initials': 'IK', 'LastName': 'Flink', 'Affiliation': 'Örebro University, Örebro, Sweden.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Boersma', 'Affiliation': 'Örebro University, Örebro, Sweden.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Linton', 'Affiliation': 'Örebro University, Örebro, Sweden.'}]",Journal of sleep research,['10.1111/jsr.12940']
246,31797399,"The therapeutic efficacy of Bifidobacterium animalis subsp. lactis BB-12 ®  in infant colic: A randomised, double blind, placebo-controlled trial.","BACKGROUND


The pathogenesis of infant colic is poorly defined. Gut microbiota seems to be involved, supporting the potential therapeutic role of probiotics.
AIMS


To assess the rate of infants with a reduction of ≥50% of mean daily crying duration after 28 days of intervention with the probiotic Bifidobacterium animalis subsp. lactis BB-12 ®  (BB-12). Secondary outcomes were daily number of crying episodes, sleeping time, number of bowel movements and stool consistency.
METHODS


Randomized controlled trial (RCT) on otherwise healthy exclusively breastfed infants with infant colic randomly allocated to receive BB-12 (1 × 10 9   CFU/day) or placebo for 28 days. Gut microbiota structure and butyrate, beta-defensin-2 (HBD-2), cathelicidin (LL-37), secretory IgA (sIgA) and faecal calprotectin levels were assessed.
RESULTS


Eighty infants were randomised, 40/group. The rate of infants with reduction of ≥50% of mean daily crying duration was higher in infants treated with BB-12, starting from the end of 2nd week. No infant relapsed when treatment was stopped. The mean number of crying episodes decreased in both groups, but with a higher effect in BB-12 group (-4.7 ± 3.4 vs -2.3 ± 2.2, P < 0.05). Mean daily stool frequency decreased in both groups but the effect was significantly higher in the BB-12 group; stool consistency was similar between the two groups. An increase in Bifidobacterium abundance (with significant correlation with crying time reduction), butyrate and HBD-2, LL-37, sIgA levels associated with a decrease in faecal calprotectin level were observed in the BB-12 group.
CONCLUSIONS


Supplementation with BB-12 is effective in managing infant colic. The effect could derive from immune and non-immune mechanisms associated with a modulation of gut microbiota structure and function.",2020,Mean daily stool frequency decreased in both groups but the effect was significantly higher in the BB-12 group; stool consistency was similar between the two groups.,"['infant colic', 'infants with a reduction of ≥50% of mean daily crying duration after 28\xa0days of intervention with the probiotic Bifidobacterium animalis subsp', 'otherwise healthy exclusively breastfed infants with infant colic randomly allocated to receive', 'Eighty infants were randomised, 40/group']","['placebo', 'Bifidobacterium animalis subsp', 'BB-12']","['Bifidobacterium abundance', 'Mean daily stool frequency', 'HBD-2), cathelicidin (LL-37), secretory IgA (sIgA) and faecal calprotectin levels', 'Gut microbiota structure and butyrate, beta-defensin-2', 'faecal calprotectin level', 'lactis BB-12 ®  (BB-12', 'mean number of crying episodes', 'mean daily crying duration', 'butyrate and HBD-2, LL-37, sIgA levels', 'daily number of crying episodes, sleeping time, number of bowel movements and stool consistency']","[{'cui': 'C0266836', 'cui_str': 'Infantile Colic'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0671062', 'cui_str': 'cathelicidin'}, {'cui': 'C0042950', 'cui_str': 'Will'}, {'cui': 'C0020838', 'cui_str': 'Secretory IgA'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0887942', 'cui_str': 'beta-Defensins'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}]",80.0,0.359795,Mean daily stool frequency decreased in both groups but the effect was significantly higher in the BB-12 group; stool consistency was similar between the two groups.,"[{'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nocerino', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'De Filippis', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Cecere', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Marino', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Micillo', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Di Scala', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'de Caro', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Calignano', 'Affiliation': 'Department of Pharmacy, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Bruno', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Paparo', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Iannicelli', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Cosenza', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Ylenia', 'Initials': 'Y', 'LastName': 'Maddalena', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Giusy', 'Initials': 'G', 'LastName': 'Della Gatta', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Coppola', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Carucci', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Ercolini', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Berni Canani', 'Affiliation': 'Department of Translational Medical Science, University of Naples Federico II, Naples, Italy.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15561']
247,31916660,"Understanding the impact of complicated grief on combat related posttraumatic stress disorder, guilt, suicide, and functional impairment in a clinical trial of post-9/11 service members and veterans.","BACKGROUND


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


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


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


Comorbid CG is associated with elevated PTSD severity and independently associated with poorer endpoint treatment outcomes in veterans with combat-related PTSD, suggesting that screening and additional intervention for CG may be needed.",2020,Those with CG had greater severity of PTSD (p = 0.005) and trauma-related guilt (<0.001) at baseline and endpoint.,"['post-9/11 service members and veterans', 'veterans with a primary diagnosis of combat-related PTSD (n\u2009=\u2009194']",['sertraline'],"['remission', 'trauma-related guilt', 'severity of PTSD', 'Assessment of PTSD, trauma-related guilt, functional impairment, and suicidal ideation and behavior', 'PTSD treatment response', 'experience suicidal ideation']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0594661,Those with CG had greater severity of PTSD (p = 0.005) and trauma-related guilt (<0.001) at baseline and endpoint.,"[{'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Hoeppner', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Lubin', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Robinaugh', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Malgaroli', 'Affiliation': 'Department of Psychiatry, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'National Center for PTSD, White River Junction, Vermont.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Acierno', 'Affiliation': 'Mental Health Service Line, Ralph H. Johnson Veterans Affairs Medical Center, Charleston, South Carolina.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Goetter', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Samantha N', 'Initials': 'SN', 'LastName': 'Hellberg', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Meredith E', 'Initials': 'ME', 'LastName': 'Charney', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bui', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Amanda W', 'Initials': 'AW', 'LastName': 'Baker', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Smith', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Mental Health Service Line, Veterans Affairs Atlanta Healthcare System, Decatur, Georgia.'}]",Depression and anxiety,['10.1002/da.22911']
248,31229734,Telepractice communication partner training for health professionals: A randomised trial.,"PURPOSE


Communication partner training can be beneficial in reducing accessibility barriers for people with aphasia The aim of the present study was to determine whether face-to-face or telepractice (real time video-teleconference system) delivery of a communication partner training program was associated with greater improvements in confidence and knowledge of effective communication strategies among allied health professionals.
METHOD


55 health professionals were randomly allocated to receive face-to-face (n = 27) or telepractice (n = 28) communication partner training. All participants completed their allocated training. A customised mixed-methods self-completed questionnaire was used before and after receiving communication partner training for participants to rate their confidence when communicating with people with aphasia using a 100mm visual analogue scale and answer an open-ended question about knowledge of communication strategies.
RESULTS


At baseline, there was no significant differences between groups in confidence ratings (median (IQR), face-to-face 48mm (32mm, 54mm), telepractice 43mm (29mm, 56mm)) or number of strategies identified (face-to-face median=4, IQR 3-5; telepractice median=3, IQR 2-4). At the post-intervention assessment, confidence was significantly higher (p<0.001) for both groups (median (IQR), face-to-face 95mm (90mm, 97mm), telepractice 93mm (88mm, 97mm)), but no significant effect of group allocation was present. Similarly, more communication strategies (p<0.001) were identified (face-to-face median=9, IQR 8-12; telepractice median=9, IQR 8-11) but no significant effect of group allocation was present.
CONCLUSIONS


This study demonstrated health professionals confidence for communicating with people with aphasia and knowledge of strategies to facilitate communication improved immediately after receiving communication partner training via either face-to-face or telepractice, but neither approach was superior.",2019,"This study demonstrated health professionals confidence for communicating with people with aphasia and knowledge of strategies to facilitate communication improved immediately after receiving communication partner training via either face-to-face or telepractice, but neither approach was superior.","['55 health professionals', 'people with aphasia', 'health professionals']","['Telepractice communication partner training', 'telepractice (n = 28) communication partner training', 'communication partner training']",['confidence ratings'],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}]",,0.029483,"This study demonstrated health professionals confidence for communicating with people with aphasia and knowledge of strategies to facilitate communication improved immediately after receiving communication partner training via either face-to-face or telepractice, but neither approach was superior.","[{'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Cameron', 'Affiliation': 'Division of Speech Pathology, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia; Speech Pathology Department, Princess Alexandra Hospital, Brisbane, Australia. Electronic address: Ashley.Cameron@health.qld.gov.au.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McPhail', 'Affiliation': 'Centre for Functioning and Health Research, Metro South Health, Queensland Health, Brisbane, Australia; School of Public Health & Social Work and Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Kyla', 'Initials': 'K', 'LastName': 'Hudson', 'Affiliation': 'Division of Speech Pathology, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Fleming', 'Affiliation': 'Centre for Functioning and Health Research, Metro South Health, Queensland Health, Brisbane, Australia; Division of Occupational Therapy, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia; Occupational Therapy Department, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lethlean', 'Affiliation': 'Speech Pathology Department, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Finch', 'Affiliation': 'Division of Speech Pathology, School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia; Speech Pathology Department, Princess Alexandra Hospital, Brisbane, Australia; Centre for Functioning and Health Research, Metro South Health, Queensland Health, Brisbane, Australia.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2019.105914']
249,31771991,Initial Results from Mobile Low-Dose Computerized Tomographic Lung Cancer Screening Unit: Improved Outcomes for Underserved Populations.,"INTRODUCTION


The National Lung Screening Trial (NLST) demonstrated that screening high-risk patients with low-dose computed tomography (CT) of the chest reduces lung cancer mortality compared with screening with chest x-ray. Uninsured and Medicaid patients usually lack access to this hospital-based screening test because of geographic and socioeconomic factors. We hypothesized that a mobile screening unit would improve access and confer the benefits demonstrated by the NLST to this underserved group, which is most at risk of lung cancer deaths.
PATIENTS AND METHODS


We created a mobile unit by building a Samsung BodyTom portable 32-slice low-dose CT scanner into a 35-foot coach; it delivers high-quality images for both soft tissue and bone and includes a waiting area and high-speed wireless internet connection for fast image transfer. The unit was extensively tested to show robustness and stability of mobile equipment. This project was designed to screen uninsured and underinsured patients, otherwise with eligibility criteria identical to that of the National Lung Screening Trial, with the only difference being exclusion of patients eligible for Medicare (which provides financial coverage for CT-based lung cancer screening).
RESULTS


We screened 550 patients (20% black, 3% Hispanic, 70% rural) with a male-to-female ratio of 1.1:1, median age 61 years (range, 55-64), and found 12 lung cancers at initial screen (2.2%), including 6 at stage I-II (58% of total lung cancers early stage) and 38 Lung-RADS 4 (highly suspicious) lesions that are being followed closely. Incidental findings included nonlung cancers and coronary artery disease.
DISCUSSION


In this initial pilot study, using the first mobile low-dose whole body CT screening unit in the U.S., the initial cancer detection rate is comparable to that reported in the NLST, despite excluding patients over the age of 64 years who have Medicare coverage, but with marked improvement of screening rates specifically in underserved sociodemographic, racial, and ethnic groups and with better outcomes than conventionally found in the underserved and at lower cost per case.
IMPLICATIONS FOR PRACTICE


This study shows clearly that a mobile low-dose CT scanning unit allows effective lung cancer screening for underserved populations, such as impoverished African Americans, Hispanics, Native Americans, or isolated rural groups, and has a pick-up rate of 1% for early stage disease. If confirmed in a planned randomized trial, this will be policy changing, as these groups usually present with advanced disease; this approach will produce better survival data at lower cost per case.",2020,"This study shows clearly that a mobile low-dose CT scanning unit allows effective lung cancer screening for underserved populations, such as impoverished African Americans, Hispanics, Native Americans, or isolated rural groups, and has a pick-up rate of 1% for early stage disease.","['550 patients (20% black, 3% Hispanic, 70% rural) with a male-to-female ratio of 1.1:1, median age 61\u2009years (range, 55-64), and found 12 lung cancers at initial screen (2.2%), including 6 at stage I-II (58% of total lung cancers early stage) and 38 Lung-RADS 4 (highly suspicious) lesions that are being followed closely', 'screen uninsured and underinsured patients, otherwise with eligibility criteria identical to that of the National Lung Screening Trial, with the only difference being exclusion of patients eligible for Medicare (which provides financial coverage for CT-based lung cancer screening']","['Mobile Low-Dose Computerized Tomographic Lung Cancer Screening Unit', 'CT scanning unit']",['lung cancer mortality'],"[{'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439175', 'cui_str': '% of total (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0556643', 'cui_str': 'rad (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087132', 'cui_str': 'Underinsured'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",550.0,0.0516046,"This study shows clearly that a mobile low-dose CT scanning unit allows effective lung cancer screening for underserved populations, such as impoverished African Americans, Hispanics, Native Americans, or isolated rural groups, and has a pick-up rate of 1% for early stage disease.","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Raghavan', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Mellisa', 'Initials': 'M', 'LastName': 'Wheeler', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Darcy', 'Initials': 'D', 'LastName': 'Doege', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Doty', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Henri', 'Initials': 'H', 'LastName': 'Levy', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Kia A', 'Initials': 'KA', 'LastName': 'Dungan', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Davis', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Robinson', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Kathryn F', 'Initials': 'KF', 'LastName': 'Mileham', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Oliver', 'Affiliation': 'Levine Cancer Institute/Atrium Health System, Charlotte, North Carolina, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Carrizosa', 'Affiliation': ''}]",The oncologist,['10.1634/theoncologist.2019-0802']
250,31202086,Intolerance of uncertainty and eating disorder behaviour: Piloting a consumption task in a non-clinical sample.,"BACKGROUND AND OBJECTIVES


Intolerance of uncertainty (IU) is a transdiagnostic process contributing to the maintenance of anxiety disorders, and is a potential target for treatment. Recent literature has investigated IU as a cognitive process underpinning pathological fear and anxiety in Anorexia Nervosa (AN). The current study was designed to examine trait and state IU, and their relationship to restrictive eating disorder symptoms, anxiety, worry, cognitive rigidity and eating behaviour.
METHODS


A sample of undergraduate women (N = 85) completed measures of eating disorder symptoms, IU, cognitive rigidity and worry. Participants were randomised to complete an eating task under one of two conditions: the ""certain"" condition received a high-calorie meal and nutritional information, while the ""uncertain"" condition received the meal alone. During the meal, state IU and state anxiety were examined at three time-points (baseline, pre-eating, post-eating).
RESULTS


Trait IU was correlated with cognitive rigidity, worry, global eating disorder symptoms, and, in particular, dietary restraint. No differences emerged between conditions with respect to eating-related anxiety, or amount of food eaten. Controlling for condition and eating disorder symptoms, state IU predicted pre-eating anxiety. Beyond the contribution of condition, BMI and eating disorder symptoms, state IU predicted consumption, specifically greater dietary restriction.
LIMITATIONS


The study employed a non-clinical sample.
CONCLUSIONS


IU may be implicated in a rigid cognitive style, the anxiety response to energy-dense food, and restrictive eating behaviour. Should these findings be replicated in a clinical sample, then IU might emerge as an adjunctive treatment target for AN.",2019,"RESULTS


Trait IU was correlated with cognitive rigidity, worry, global eating disorder symptoms, and, in particular, dietary restraint.",['A sample of undergraduate women (N\u202f=\u202f85'],"['certain"" condition received a high-calorie meal and nutritional information, while the ""uncertain"" condition received the meal alone']","['eating-related anxiety, or amount of food eaten', 'restrictive eating disorder symptoms, anxiety, worry, cognitive rigidity and eating behaviour', 'cognitive rigidity, worry, global eating disorder symptoms', 'eating disorder symptoms, IU, cognitive rigidity and worry', 'Intolerance of uncertainty and eating disorder behaviour', 'condition and eating disorder symptoms, state IU predicted pre-eating anxiety']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}]","[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0026837', 'cui_str': 'Rigidity, Muscular'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",,0.0457994,"RESULTS


Trait IU was correlated with cognitive rigidity, worry, global eating disorder symptoms, and, in particular, dietary restraint.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Kesby', 'Affiliation': 'School of Psychology, UNSW Sydney, Sydney, NSW, Australia; Inside Out Institute, University of Sydney, Sydney, NSW, Australia. Electronic address: a.kesby@psy.unsw.edu.au.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Maguire', 'Affiliation': 'Inside Out Institute, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Lenny R', 'Initials': 'LR', 'LastName': 'Vartanian', 'Affiliation': 'School of Psychology, UNSW Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Grisham', 'Affiliation': 'School of Psychology, UNSW Sydney, Sydney, NSW, Australia.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101492']
251,31382210,"Effects of transcutaneous electrical nervous stimulation (TENS) associated with vocal therapy on musculoskeletal pain of women with behavioral dysphonia: A randomized, placebo-controlled double-blind clinical trial.","Recently, electrical stimulation in vocal rehabilitation has been the subject of studies. This treatment has shown promising results regarding the decrease of vocal/laryngeal symptoms, pain and the improvement of vocal tension. In addition to decreasing pain symptoms, TENS treatments may lead to muscle relaxation. There is no data on the effects of this resource as a vocal therapy in women with behavioral dysphonia. Research in this area may provide evidence to assist the clinical decision related to the treatment of women with complaints of behavioral dysphonia and musculoskeletal pain.
OBJECTIVE


To verify the effects of low-frequency TENS in association with vocal therapy on musculoskeletal pain in women with behavioral dysphonia.
METHODS


Participants included 27 women with vocal nodules randomized into two groups. The experimental group (EG) - 13 women received 12 sessions of TENS (pulse of 200 μs, frequency at 10 Hz, in motor threshold) with electrodes placed bilaterally on the trapezius muscle and submandibular area for 20 min followed by 30 min of vocal therapy, and the control group (CG) - 14 women received 12 sessions of 20 min of a placebo TENS followed by 30 min of vocal therapy. We investigated the frequency and intensity of the musculoskeletal pain in several body regions, as well as the intensity of pain at rest and in the application of pressure with an algometer applied to the descending fibers of the trapezius muscle. The pressure-pain threshold (PPT) was also investigated. All evaluations occurred before, immediately after, and at one and three months after treatment in both groups.
RESULTS


We observed a reduction in the frequency of pain in the larynx after treatment of both groups, but only the EG showed a decrease in pain intensity in this region. It was verified with an algometer to the trapezius muscle that the electrical stimulation associated with the vocal therapy decreased the intensity of pain during the application of pressure and increased the PPT. There were no significant differences with regard to variables investigated in the comparison between the interventions. On the other hand, there was decreased pain in the trapezius muscle for the EG in comparison to the pre- and post-intervention.
CONCLUSION


The vocal therapyprogram reduced the frequency and intensity of the musculoskeletal pain in the regions proximal to the larynx of women with behavioral dysphonia. In addition, TENS followed by vocal therapy increased the threshold of sensitivity to muscular pain in the trapezius, demonstrating that it is a good resource to use in conjunction with traditional vocal therapy in cases of behavioral dysphonia associated with pain and muscle tension.",2019,The vocal therapyprogram reduced the frequency and intensity of the musculoskeletal pain in the regions proximal to the larynx of women with behavioral dysphonia.,"['women with behavioral dysphonia', 'women with complaints of behavioral dysphonia and musculoskeletal pain', 'Participants included 27 women with vocal nodules randomized into two groups']","['transcutaneous electrical nervous stimulation (TENS', 'TENS (pulse of 200\u2009μs, frequency at 10\u2009Hz, in motor threshold) with electrodes placed bilaterally on the trapezius muscle and submandibular area for 20\u2009min followed by 30\u2009min of vocal therapy, and the control group (CG) - 14 women received 12 sessions of 20\u2009min of a placebo TENS followed by 30\u2009min of vocal therapy', 'TENS', 'vocal therapy', 'placebo', 'low-frequency TENS']","['pain intensity', 'pain', 'frequency and intensity of the musculoskeletal pain', 'pain symptoms', 'vocal/laryngeal symptoms, pain and the improvement of vocal tension', 'frequency of pain', 'intensity of pain', 'musculoskeletal pain', 'pressure-pain threshold (PPT']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1527344', 'cui_str': 'Phonation Disorders'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0028259', 'cui_str': 'Nodule (morphologic abnormality)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0591126', 'cui_str': 'AT 10'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0224361', 'cui_str': 'Trapezius'}, {'cui': 'C0230070', 'cui_str': 'Trigone submandibulare'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}]",27.0,0.046751,The vocal therapyprogram reduced the frequency and intensity of the musculoskeletal pain in the regions proximal to the larynx of women with behavioral dysphonia.,"[{'ForeName': 'Larissa Thais Donalonso', 'Initials': 'LTD', 'LastName': 'Siqueira', 'Affiliation': 'Universidade Estadual do Centro-Oeste - UNICENTRO, Irati, Paraná, Brazil. Electronic address: larisiqueira_4@hotmail.com.'}, {'ForeName': 'Vanessa Veis', 'Initials': 'VV', 'LastName': 'Ribeiro', 'Affiliation': 'Centro Universitário do Cerrado Patrocínio - UNICERP, Patrocínio, Minas Gerais, Brazil. Electronic address: fgavanessavr@gmail.com.'}, {'ForeName': 'Pamela Aparecida Medeiros', 'Initials': 'PAM', 'LastName': 'Moreira', 'Affiliation': 'Disorders Department of the Faculdade de Odontologia de Bauru/Universidade de São Paulo - FOB/USP, Bauru, São Paulo, Brazil. Electronic address: pamela_moreria15@yahoo.com.br.'}, {'ForeName': 'Alcione Ghedini', 'Initials': 'AG', 'LastName': 'Brasolotto', 'Affiliation': 'Disorders Department of the Faculdade de Odontologia de Bauru/Universidade de São Paulo - FOB/USP, Bauru, São Paulo, Brazil. Electronic address: alcione@usp.br.'}, {'ForeName': 'Rinaldo Roberto', 'Initials': 'RR', 'LastName': 'de Jesus Guirro', 'Affiliation': 'Faculdade de Medicina de Ribeirão Preto/Universidade de São Paulo - FMRP/USP, Ribeirão Preto, São Paulo, Brazil. Electronic address: rguirro@fmrp.usp.br.'}, {'ForeName': 'Kelly Cristina', 'Initials': 'KC', 'LastName': 'Alves Silverio', 'Affiliation': 'Disorders Department of the Faculdade de Odontologia de Bauru/Universidade de São Paulo - FOB/USP, Bauru, São Paulo, Brazil. Electronic address: kellysilverio@usp.br.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2019.105923']
252,31758610,UCC118 supplementation reduces exercise-induced gastrointestinal permeability and remodels the gut microbiome in healthy humans.,"Dysregulation of gut microbiota and intestinal barrier function has emerged as potential mechanisms underlying digestive diseases, yet targeted therapies are lacking The purpose of this investigation was to assess the efficacy of UCC118, a characterized probiotic strain, on exercise-induced GI permeability in healthy humans. In a randomized, double-blind, placebo-controlled crossover study, seven healthy adults received 4 weeks of daily UCC118 or placebo supplementation. GI hyperpermeability was induced by strenuous treadmill running performed before and after each supplementation period. While running, participants ingested 5 g of lactulose, rhamnose, and sucrose. Urine was collected before, immediately after, and every hour for 5 h after exercise to assess GI permeability. Metagenomic sequencing was performed on fecal homogenates collected prior to exercise to identify changes in microbial diversity and taxon abundances. Inflammatory biomarkers were assessed from blood and fecal homogenates collected prior to and immediately following the cessation of exercise. Exercise significantly induced intestinal permeability of lactulose, rhamnose, and sucrose (P < 0.001). UCC118 significantly reduced sucrose (Δ = -0.38 ± 0.13 vs. 1.69 ± 0.79; P < 0.05) recovery, with no substantial change in lactulose (Δ = -0.07 ± 0.23 vs. 0.35 ± 0.15; P = 0.16) or rhamnose (Δ = -0.06 ± 0.22 vs. 0.48 ± 0.28; P = 0.22). Taxonomic sequencing revealed 99 differentially regulated bacteria spanning 6 taxonomic ranks (P < 0.05) after UCC118 supplementation. No differences in plasma IL-6 or fecal zonulin were observed after UCC118 supplementation. The results described herein provide proof of principle that 4 weeks of UCC118 supplementation attenuated exercise-induced intestinal hyperpermeability. Further research is warranted to investigate the as-yet-to-be defined molecular processes of intestinal hyperpermeability and the effects of probiotic supplementation.",2019,"Exercise significantly induced intestinal permeability of lactulose, rhamnose, and sucrose (P < 0.001).","['seven healthy adults', 'healthy humans']","['placebo', 'UCC118 supplementation', 'UCC118 or placebo supplementation']","['Inflammatory biomarkers', 'intestinal hyperpermeability', 'GI hyperpermeability', 'plasma IL-6 or fecal zonulin', 'intestinal permeability of lactulose, rhamnose, and sucrose']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0914216', 'cui_str': 'prehaptoglobin 2'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0035417', 'cui_str': 'rhamnose'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}]",,0.200239,"Exercise significantly induced intestinal permeability of lactulose, rhamnose, and sucrose (P < 0.001).","[{'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Axelrod', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Connery J', 'Initials': 'CJ', 'LastName': 'Brennan', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Cresci', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Paul', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Hull', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Ciarán E', 'Initials': 'CE', 'LastName': 'Fealy', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kirwan', 'Affiliation': 'Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.'}]",Physiological reports,['10.14814/phy2.14276']
253,32297259,Effects of a fast track surgery nursing program in perioperative care of older patients with a hip fracture.,"PURPOSE


The nursing concept has changed from being ""disease centered"" to ""patient centered"". The aim of this study was to explore the clinical effects of a fast track surgery nursing program in the perioperative care of older patients with a hip fracture.
METHODS


Total of 84 patients with hip fracture who were hospitalized in our department were randomly divided into the conventional group (42 cases) and fast track surgery group (42 cases) to compare the psychological state, pain degree, serum inflammatory factors, coagulation, hip function, and incidence of deep venous thrombosis of lower extremities between the groups before and after the nursing program.
RESULTS


There were no significant differences between groups as measured by a self-rating anxiety scale, self-rating depression scale, visual analogue score, IL-6, IL-10, TNF-α, coagulation factor level, or Harris score between groups before nursing (P > 0.05). The self-rating anxiety scale, self-rating depression scale, visual analogue score, IL-6, IL-10, TNF-a, coagulation factor level, and deep venous thrombosis in fast track surgery group after nursing were significantly lower than in the conventional group, and the Harris score was significantly higher (P < 0.05).
CONCLUSIONS


The fast track surgery nursing program can effectively alleviate adverse emotions and pain of patients with a hip fracture, reduce inflammation, improve coagulation and hip function after operation, and reduce the incidence of deep venous thrombosis after operation.",2020,"There were no significant differences between groups as measured by a self-rating anxiety scale, self-rating depression scale, visual analogue score, IL-6, IL-10, TNF-α, coagulation factor level, or Harris score between groups before nursing (P > 0.05).","['Total of 84 patients with hip fracture who were hospitalized in our department', 'older patients with a hip fracture']","['conventional group (42 cases) and fast track surgery', 'fast track surgery nursing program']","['psychological state, pain degree, serum inflammatory factors, coagulation, hip function, and incidence of deep venous thrombosis of lower extremities', 'self-rating anxiety scale, self-rating depression scale, visual analogue score, IL-6, IL-10, TNF-α, coagulation factor level, or Harris score', 'self-rating anxiety scale, self-rating depression scale, visual analogue score, IL-6, IL-10, TNF-a, coagulation factor level, and deep venous thrombosis']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0340708', 'cui_str': 'Deep venous thrombosis of lower extremity'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0005789', 'cui_str': 'Blood clotting factor'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}]",84.0,0.0142273,"There were no significant differences between groups as measured by a self-rating anxiety scale, self-rating depression scale, visual analogue score, IL-6, IL-10, TNF-α, coagulation factor level, or Harris score between groups before nursing (P > 0.05).","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Spine Surgery, Second Affiliated Hospital, Harbin Medical University, Baojian Road 146, Harbin, 150086, China. huilidoc@126.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Blood Sampling Room, First Affiliated Hospital, Harbin Medical University, Youzheng Road 23, Harbin, 150001, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory, Second Affiliated Hospital, Harbin Medical University, Baojian Road 146, Harbin, 150086, China.'}, {'ForeName': 'Jialing', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Department of Spine Surgery, Second Affiliated Hospital, Harbin Medical University, Baojian Road 146, Harbin, 150086, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Gan', 'Affiliation': 'Department of Spine Surgery, Second Affiliated Hospital, Harbin Medical University, Baojian Road 146, Harbin, 150086, China.'}, {'ForeName': 'Yixuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Spine Surgery, Second Affiliated Hospital, Harbin Medical University, Baojian Road 146, Harbin, 150086, China.'}]",European geriatric medicine,['10.1007/s41999-020-00298-y']
254,31809439,Mifepristone Antagonization With Progesterone to Prevent Medical Abortion: A Randomized Controlled Trial.,"OBJECTIVE


To estimate the efficacy and safety of mifepristone antagonization with high-dose oral progesterone.
METHODS


We planned to enroll 40 patients in a double-blind, placebo-controlled, randomized trial. We enrolled patients at 44-63 days of gestation with ultrasound-confirmed gestational cardiac activity who were planning surgical abortion. Participants ingested mifepristone 200 mg and initiated oral progesterone 400 mg or placebo 24 hours later twice daily for 3 days, then once daily until their planned surgical abortion 14-16 days after enrollment. Follow-up visits were scheduled 3±1, 7±1, and 15±1 days after mifepristone intake with ultrasonography and blood testing for human chorionic gonadotropin and progesterone. Participants exited from the study when they had their surgical abortion or earlier for gestational cardiac activity absence, gestational sac expulsion, or medically indicated suction aspiration. We assessed the primary outcome of continued gestational cardiac activity at approximately 2 weeks (15±1 day), side effects after drug ingestion, and safety outcomes including hemorrhage and emergent treatment.
RESULTS


We enrolled participants from February to July 2019 and stopped enrollment after 12 patients for safety concerns. Mean gestational age was 52.5 days. Two (one per group) voluntarily discontinued 3 days after mifepristone ingestion for subjective symptoms (nausea and vomiting, bleeding). Among the remaining 10 patients (five per group), gestational cardiac activity continued for 2 weeks in four in the progesterone group and two in the placebo group. One patient in the placebo group had no gestational cardiac activity 3 days after mifepristone use. Severe hemorrhage requiring ambulance transport to hospital occurred in three patients; one received progesterone (complete expulsion, no aspiration) and two received placebo (aspiration for both, one required transfusion). We halted enrollment after the third hemorrhage. No other significant side effects were reported.
CONCLUSION


We could not estimate the efficacy of progesterone for mifepristone antagonization due to safety concerns when mifepristone is administered without subsequent prostaglandin analogue treatment. Patients in early pregnancy who use only mifepristone may be at high risk of significant hemorrhage.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT03774745.",2020,"No other significant side effects were reported.
","['enrolled participants from February to July 2019 and stopped enrollment after 12 patients for safety concerns', 'enrolled patients at 44-63 days of gestation with ultrasound-confirmed gestational cardiac activity who were planning surgical abortion', 'Medical Abortion', 'Participants exited from the study when they had their surgical abortion or earlier for gestational cardiac activity absence, gestational sac expulsion, or medically indicated suction aspiration']","['Progesterone', 'Mifepristone Antagonization', 'mifepristone intake with ultrasonography and blood testing for human chorionic gonadotropin and progesterone', 'mifepristone antagonization with high-dose oral progesterone', 'mifepristone 200 mg and initiated oral progesterone 400 mg or placebo', 'mifepristone', 'progesterone', 'placebo', 'mifepristone ingestion']","['efficacy and safety', 'side effects after drug ingestion, and safety outcomes including hemorrhage and emergent treatment', 'subjective symptoms (nausea and vomiting, bleeding', 'gestational cardiac activity', 'Severe hemorrhage requiring ambulance transport to hospital', 'continued gestational cardiac activity']","[{'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0443168', 'cui_str': 'Cardiac activity (observable entity)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C3146283', 'cui_str': 'Medical abortion'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0553498', 'cui_str': 'Gestation Sac'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}]","[{'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0005768'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement (procedure)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1592637', 'cui_str': 'Mifepristone 200 MG [Mifeprex]'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0443168', 'cui_str': 'Cardiac activity (observable entity)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002422', 'cui_str': 'Ambulances'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",40.0,0.699712,"No other significant side effects were reported.
","[{'ForeName': 'Mitchell D', 'Initials': 'MD', 'LastName': 'Creinin', 'Affiliation': ""Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, Planned Parenthood Mar Monte, San Jose, and FPA Women's Health, Sacramento, California.""}, {'ForeName': 'Melody Y', 'Initials': 'MY', 'LastName': 'Hou', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dalton', 'Affiliation': ''}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Steward', 'Affiliation': ''}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Chen', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003620']
255,31312016,Advanced weight-bearing mat exercises combined with functional electrical stimulation to improve the ability of wheelchair-dependent people with spinal cord injury to transfer and attain independence in activities of daily living: a randomized controlled trial.,"STUDY DESIGN


Randomized controlled trial.
OBJECTIVE


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


An outpatient clinic, Iran.
METHODS


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


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


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


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


Advanced weight-bearing mat exercises improve the ability of wheelchair-dependent people with SCI to transfer and attain independence in ADL.","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Rahimi', 'Affiliation': 'Department of Physiotherapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Giti', 'Initials': 'G', 'LastName': 'Torkaman', 'Affiliation': 'Department of Physiotherapy, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. torkamg@modares.ac.ir.'}, {'ForeName': 'Mojdeh', 'Initials': 'M', 'LastName': 'Ghabaee', 'Affiliation': 'Iranian Center of Neurological Research, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghasem-Zadeh', 'Affiliation': 'Departments of Medicine and Endocrinology, Austin Health, The University of Melbourne, Melbourne, VIC, Australia.'}]",Spinal cord,['10.1038/s41393-019-0328-7']
256,32280826,Online Prostate-Specific Membrane Antigen and Positron Emission Tomography-Guided Radiation Therapy for Oligometastatic Prostate Cancer.,"Purpose


Stereotactic ablative radiation therapy (SABR) for oligometastatic prostate cancer (OMPC) may improve clinical outcomes, but current challenges in intrafraction tracking of multiple small targets limits treatment accuracy. A biology-guided radiation therapy (BgRT) delivery system incorporating positron emission tomography (PET) detectors is being developed to use radiotracer uptake as a biologic fiducial for intrafraction tumor tracking to improve geometric accuracy. This study simulates prostate-specific membrane antigen (PSMA)-directed BgRT using a cohort from our phase II randomized trial of SABR in men with recurrent hormone sensitive OMPC and compares dose distributions to clinical SABR (CSABR).
Methods and Materials


A research treatment planning system (RTPS) was used to replan 15 patients imaged with PSMA-targeted  18 F-DCFPyL PET/computed tomography and previously treated with CSABR using conventional linear accelerators (linacs). The RTPS models a prototype ring-mounted linac incorporating PET and kilo-voltage computed tomography imaging subsystems and can be used to optimize BgRT plans, as well as research SABR (RSABR) plans, which use the prototype linac without radiotracer guidance. CSABR, RSABR, and BgRT plans were compared in terms of maximum planning target volume (PTV) dose (D max ), mean dose to proximal organs at risk (D OAR ), conformity index, as well as voxel-wise correlation of dose with PET specific uptake values to investigate possible dose-painting effects.
Results


RSABR and BgRT plans resulted in mean ± standard deviation increases in D max  of 4 ± 11% ( P  = .21) and 18 ± 15% ( P  < .001) and reductions in D OAR  of -20 ± 19% ( P  <.001) and -10 ± 19% ( P  = .02) compared with CSABR. Similar target coverage was maintained with conformity indices of 0.81 ± 0.04 ( P  < .001) and 0.72 ± 0.08 ( P  = .44) for RSABR and BgRT compared with 0.74 ± 0.08 for CSABR. Dose and log (specific uptake values) had Pearson correlation coefficients of 0.10 (CSABR), 0.16 (RSABR), and 0.31 (BgRT).
Conclusions


BgRT plans provided similar PTV coverage and conformity compared with CSABR while incorporating underlying PET activity. These results demonstrate feasibility of BgRT optimization enabling online PSMA-targeted, PET-based tracked dose delivery for OMPC.",2020,Similar target coverage was maintained with conformity indices of 0.81 ± 0.04 ( P  < .001) and 0.72 ± 0.08 ( P  = .44) for RSABR and BgRT compared with 0.74 ± 0.08 for CSABR.,"['Oligometastatic Prostate Cancer', 'men with recurrent hormone sensitive OMPC and compares dose distributions to clinical SABR (CSABR', 'oligometastatic prostate cancer (OMPC', 'replan 15 patients imaged with PSMA-targeted  18 F-DCFPyL PET/computed tomography and previously treated with CSABR using conventional linear accelerators (linacs']","['Online Prostate-Specific Membrane Antigen and Positron Emission Tomography-Guided Radiation Therapy', 'guided radiation therapy (BgRT', 'Stereotactic ablative radiation therapy (SABR', 'SABR']","['CSABR, RSABR, and BgRT plans']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C0302995', 'cui_str': 'Fluorine-18'}, {'cui': 'C3492635', 'cui_str': '(18F)DCFPyL'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023730', 'cui_str': 'Linear accelerator'}]","[{'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0005532', 'cui_str': 'Biology'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005532', 'cui_str': 'Biology'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]",,0.0500735,Similar target coverage was maintained with conformity indices of 0.81 ± 0.04 ( P  < .001) and 0.72 ± 0.08 ( P  = .44) for RSABR and BgRT compared with 0.74 ± 0.08 for CSABR.,"[{'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Hrinivich', 'Affiliation': 'Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins Medicine, Baltimore, Maryland.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins Medicine, Baltimore, Maryland.'}, {'ForeName': 'Angela J', 'Initials': 'AJ', 'LastName': 'Da Silva', 'Affiliation': 'RefleXion Medical, Hayward, California.'}, {'ForeName': 'Noura', 'Initials': 'N', 'LastName': 'Radwan', 'Affiliation': 'Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins Medicine, Baltimore, Maryland.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gorin', 'Affiliation': 'Deparment of Urology, James Buchanan Urological Institute, Johns Hopkins Medicine, Baltimore, Maryland.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'Deparment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine, Baltimore, Maryland.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Pienta', 'Affiliation': 'Deparment of Urology, James Buchanan Urological Institute, Johns Hopkins Medicine, Baltimore, Maryland.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Pomper', 'Affiliation': 'Deparment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine, Baltimore, Maryland.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins Medicine, Baltimore, Maryland.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins Medicine, Baltimore, Maryland.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kang-Hsin Wang', 'Affiliation': 'Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins Medicine, Baltimore, Maryland.'}]",Advances in radiation oncology,['10.1016/j.adro.2019.10.006']
257,31394412,Immediate and short term effects of values-based interventions on paranoia.,"BACKGROUND AND OBJECTIVES


Paranoia is a common, distressing, and persistent experience that can negatively impact on health, wellbeing, and functioning. This study examined the immediate and short term (2-weeks) effects of two values-based interventions, versus a non-values control, on paranoia, as well as the moderating effect of self-esteem.
METHODS


171 non-clinical adults were randomised to a value-affirmation and goals task (VAG: clarifying and reflecting on core values and setting value-based goals) (n = 57), a value-affirmation task (VA: clarifying and reflecting on core values without setting value-based goals) (n = 57), or a non-affirmation control task (NAC) (n = 57). Paranoia was assessed at baseline (T1), post-intervention (T2), and two weeks post-intervention (T3). Self-esteem was measured at baseline.
RESULTS


VAG participants had significantly lower state paranoia scores at T3 than VA (d = .34) and NAC (d = .31) participants. This effect was moderated by trait self-esteem: At follow-up, the differential effect of condition on state paranoia was greatest amongst those with low self-esteem, with the VAG condition being most beneficial for participants with low self-esteem and the VA condition being least beneficial.
LIMITATIONS


Without a goals only control group it is possible that the benefits of VAG over VA were attributable to setting and achieving goals. Use of a nonclinical sample limits generalisability to clinical groups.
CONCLUSIONS


The findings suggest that focusing on a deeply held value and setting goals in line with that value reduced paranoia. This intervention may be most beneficial for individuals with low self-esteem.",2019,"RESULTS


VAG participants had significantly lower state paranoia scores at T3 than VA (d = .34) and NAC (d = .31) participants.","['171 non-clinical adults', 'individuals with low self-esteem']","['value-affirmation and goals task (VAG: clarifying and reflecting on core values and setting value-based goals) (n\u202f=\u202f57), a value-affirmation task (VA: clarifying and reflecting on core values without setting value-based goals) (n\u202f=\u202f57), or a non-affirmation control task (NAC']","['Self-esteem', 'state paranoia scores']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0679136', 'cui_str': 'Low self-esteem (finding)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1456784', 'cui_str': 'Paranoia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",171.0,0.0808331,"RESULTS


VAG participants had significantly lower state paranoia scores at T3 than VA (d = .34) and NAC (d = .31) participants.","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Evans', 'Affiliation': 'Royal Holloway, University of London, Egham Hill, Egham, TW10 0EX, Surrey, UK.'}, {'ForeName': 'Lyn', 'Initials': 'L', 'LastName': 'Ellett', 'Affiliation': 'Royal Holloway, University of London, Egham Hill, Egham, TW10 0EX, Surrey, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Carpenter', 'Affiliation': 'Royal Holloway, University of London, Egham Hill, Egham, TW10 0EX, Surrey, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kingston', 'Affiliation': 'Royal Holloway, University of London, Egham Hill, Egham, TW10 0EX, Surrey, UK. Electronic address: jessica.kingston@rhul.ac.uk.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2019.101500']
258,32243609,The benefits of iron supplementation following blood donation vary with baseline iron status.,"Whole blood donation rapidly removes approximately 10% of a donor's blood volume and stimulates substantial changes in iron metabolism and erythropoiesis. We sought to identify donors who benefit from iron supplementation, describe the nature of the benefit, and define the time course for recovery from donation. Blood samples were collected over 24 weeks following whole blood donation from 193 participants, with 96 participants randomized to 37.5 mg daily oral iron. Changes in total body, red blood cell (RBC), and storage iron, hepcidin, erythropoietin, and reticulocyte count were modeled using semiparametric curves in a mixed model. and the changes were compared among six groups defined by baseline ferritin (<12; 12-50; ≥50 ng/mL) and iron supplementation. The effect of oral iron on storage and RBC iron recovery was minimal in donors with baseline ferritin ≥50 ng/mL, but sizeable when ferritin was <50 ng/mL. Iron initially absorbed went to RBC and storage iron pools when ferritin was <12 ng/mL but went mostly to RBCs when ferritin was ≥12 ng/mL. Donors with ferritin ≥12 ng/mL had a ""ripple"" increase in reticulocytes ~100 days after donation indicating physiological responses occur months following donation. Thus, iron supplements markedly enhance recovery from whole blood donation in donors with ferritin <50 ng/mL. However, full recovery from donation requires over 100 days when taking iron. The findings also highlight the value of the study of blood donors for understanding human hemoglobin and iron metabolism and their usefulness for future studies as additional biomarkers are discovered.",2020,"The effect of oral iron on storage and RBC iron recovery was minimal in donors with baseline ferritin ≥50 ng/mL, but sizeable when ferritin was <50 ng/mL. Iron initially absorbed went to RBC and storage iron pools when ferritin was <12 ng/mL but went mostly to RBCs when ferritin was ≥12 ng/mL. Donors with ferritin ≥12","['donors with baseline ferritin ≥50 ng/mL, but sizeable when ferritin was <50 ng/mL. Iron initially absorbed went to RBC and storage iron pools when ferritin was <12 ng/mL but went mostly to RBCs when ferritin was ≥12 ng/mL. Donors with ferritin ≥12', 'donors with ferritin <50 ng/mL']",['iron supplementation'],"['storage and RBC iron recovery', 'total body, RBC, and storage iron, hepcidin, erythropoietin, and reticulocyte count']","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0014792', 'cui_str': 'erythrocytes'}]","[{'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]","[{'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0206161', 'cui_str': 'Reticulocyte count'}]",96.0,0.117661,"The effect of oral iron on storage and RBC iron recovery was minimal in donors with baseline ferritin ≥50 ng/mL, but sizeable when ferritin was <50 ng/mL. Iron initially absorbed went to RBC and storage iron pools when ferritin was <12 ng/mL but went mostly to RBCs when ferritin was ≥12 ng/mL. Donors with ferritin ≥12","[{'ForeName': 'Alan E', 'Initials': 'AE', 'LastName': 'Mast', 'Affiliation': 'Blood Research Institute, Versiti, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Aniko', 'Initials': 'A', 'LastName': 'Szabo', 'Affiliation': 'Division of Biostatistics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Mars', 'Initials': 'M', 'LastName': 'Stone', 'Affiliation': 'Vitalant Research Institute, San Francisco, California, USA.'}, {'ForeName': 'Ritchard G', 'Initials': 'RG', 'LastName': 'Cable', 'Affiliation': 'American Red Cross Scientific Affairs, Farmington, Connecticut, USA.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Spencer', 'Affiliation': 'American Red Cross Scientific Affairs, Dedham, Massachusetts, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Kiss', 'Affiliation': 'Vitalant Northeast Division, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of hematology,['10.1002/ajh.25800']
259,32108364,ERP evidence suggests that confrontation with deterministic statements aligns subsequent other- and self-relevant error processing.,"This study used event-related potential (ERP) measurements to investigate whether error processing in a social context is modulated by top-down influence of deterministic thinking, i.e., subjective beliefs that events are pre-determined by previously existing causes. To this end, half of our participants were confronted with statements denying the existence of free will, aimed to induce more deterministic thinking, whereas the other half was assigned to a control group that read neutral statements. Thereafter, all participants performed a choice-reaction task for their own and for the benefit of a second participant. Error rates were comparable in both groups and benefit settings, while only control participants showed enhanced post-error slowing (PES) in other- compared to self-relevant trials. On the neural level, other-relevant errors elicited diminished early error signals (reduced ΔERN amplitudes) in deterministic-intervention participants compared to controls. In subsequent processing, ERPs of deterministic-intervention participants did not differentiate between the benefit settings, while controls showed reduced ΔPe amplitudes for others compared to self-relevant errors. Taken together, our findings suggest that being confronted with deterministic compared to control statements reduced subsequent processing differences between other- and self-relevant error processing. This might be beneficial in social evaluation or intergroup situations because it could decrease self-cenetred processing biases often observed in these situations.",2020,"In subsequent processing, ERPs of deterministic-intervention participants did not differentiate between the benefit settings, while controls showed reduced ΔPe amplitudes for others compared to self-relevant errors.",[],[],"['Error rates', 'ΔPe amplitudes', 'enhanced post-error slowing (PES']",[],[],"[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}]",,0.0610241,"In subsequent processing, ERPs of deterministic-intervention participants did not differentiate between the benefit settings, while controls showed reduced ΔPe amplitudes for others compared to self-relevant errors.","[{'ForeName': 'Daniela M', 'Initials': 'DM', 'LastName': 'Pfabigan', 'Affiliation': 'Department of Behavioural Sciences in Medicine, Institute for Basic Medical Science, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Mielacher', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Dutheil', 'Affiliation': 'Université Clermont Auvergne, CNRS, LaPSCo, Physiological and Psychosocial Stress, University Hospital of Clermont-Ferrand, CHU Clermont-Ferrand, Preventive and Occupational Medicine, WittyFit, Clermont-Ferrand, France.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Vienna, Austria.'}]",Psychophysiology,['10.1111/psyp.13556']
260,31253849,Effects of a coping-oriented supportive programme for people with spinal cord injury during inpatient rehabilitation: a quasi-experimental study.,"STUDY DESIGN


Parallel-group, quasi-experimental study.
OBJECTIVES


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


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


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


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


The COSP intervention resulted in medium-term psychosocial benefits for people with SCI and has potential for integration into routine inpatient rehabilitation practice.",2020,"Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
","['people with spinal cord injury during inpatient rehabilitation', 'SCI wards in two rehabilitation hospitals of Shaanxi, China', 'people with spinal cord injury (SCI', 'Ninety-nine participants (mean age\u2009=\u200941, 88% males and 74% paraplegia) joined the', 'n\u2009=\u200950) or attention control (n\u2009=\u200949) group']","['coping-oriented supportive programme', 'coping-oriented supportive programme (COSP', 'COSP intervention']","['Maladaptive coping, anxiety, satisfaction of social support and life satisfaction', ""participants' maladaptive coping, adaptive coping, self-efficacy, depression, anxiety, satisfaction of social support and life satisfaction"", 'maladaptive coping, self-efficacy, anxiety, depression, satisfaction of social support and life satisfaction', 'primary outcomes (coping and self-efficacy) and secondary outcomes (depression, anxiety, social support, life satisfaction and pain']","[{'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037438'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",99.0,0.0323196,"Maladaptive coping, anxiety, satisfaction of social support and life satisfaction were also significantly improved at 12-week follow-up.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""The Florence Nightingale Faculty of Nursing, Midwifery and Palliative Care, King's College London, London, UK. yan.li@kcl.ac.uk.""}, {'ForeName': 'Wai Tong', 'Initials': 'WT', 'LastName': 'Chien', 'Affiliation': 'The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bressington', 'Affiliation': 'The School of Nursing, Faculty of Health and Social Science, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Spinal cord,['10.1038/s41393-019-0320-2']
261,31020900,Atorvastatin Has a Dose-Dependent Beneficial Effect on Kidney Function and Associated Cardiovascular Outcomes: Post Hoc Analysis of 6 Double-Blind Randomized Controlled Trials.,"Background Kidney function decreases during the lifetime, and this decline is a powerful predictor of both kidney and cardiovascular outcomes. Statins lower cardiovascular risk, which may relate to beneficial effects on kidney function. We studied whether atorvastatin influences kidney function decline and assessed the association between individual kidney function slopes and cardiovascular outcome. Methods and Results Data were collected from 6 large atorvastatin cardiovascular outcome trials conducted in patients not selected for having kidney disease. Slopes of serum creatinine reciprocals representing measures of kidney function change ([mg/dL] -1 /y), were analyzed in 30 621 patients. Based on treatment arms, patients were categorized into 3 groups: placebo (n=10 057), atorvastatin 10 mg daily (n=12 763), and 80 mg daily (n=7801). To assess slopes, mixed-model analyses were performed for each treatment separately, including time in years and adjustment for study. These slopes displayed linear improvement over time in all 3 groups. Slope estimates for patients randomized to placebo or atorvastatin 10 mg and 80 mg were 0.009 (0.0008), 0.011 (0.0006), and 0.014 (0.0006) (mg/dL) -1 /y, respectively. A head-to-head comparison of atorvastatin 10 and 80 mg based on data from 1 study ( TNT [Treating to New Targets]; n=10 001) showed a statistically significant difference in slope between the 2 doses ( P=0.0009). From a Cox proportional hazards model using slope as a predictor, a significant ( P<0.0001) negative association between kidney function and cardiovascular outcomes was found. Conclusions In patients at risk of or with cardiovascular disease, atorvastatin improved kidney function over time in a dose-dependent manner. In the 3 treatment groups, kidney function improvement was strongly associated with lower cardiovascular risk. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifiers: NCT00327418; NCT00147602; NCT00327691.",2019,"Slope estimates for patients randomized to placebo or atorvastatin 10 mg and 80 mg were 0.009 (0.0008), 0.011 (0.0006), and 0.014 (0.0006) (mg/dL)","['patients not selected for having kidney disease', '30\xa0621 patients']","['atorvastatin', 'Atorvastatin', 'placebo or atorvastatin', 'placebo']","['Kidney Function and Associated Cardiovascular Outcomes', 'kidney function improvement', 'kidney function and cardiovascular outcomes', 'kidney function', 'cardiovascular risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",30621.0,0.0613088,"Slope estimates for patients randomized to placebo or atorvastatin 10 mg and 80 mg were 0.009 (0.0008), 0.011 (0.0006), and 0.014 (0.0006) (mg/dL)","[{'ForeName': 'Liffert', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': '1 Department of Internal Medicine Amsterdam Cardiovascular Sciences Amsterdam University Medical Centre University of Amsterdam The Netherlands.'}, {'ForeName': 'Sripal', 'Initials': 'S', 'LastName': 'Bangalore', 'Affiliation': '2 Division of Cardiology New York University School of Medicine New York NY.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Fayyad', 'Affiliation': '3 Pfizer New York NY.'}, {'ForeName': 'Shari', 'Initials': 'S', 'LastName': 'Melamed', 'Affiliation': '3 Pfizer New York NY.'}, {'ForeName': 'G Kees', 'Initials': 'GK', 'LastName': 'Hovingh', 'Affiliation': '1 Department of Internal Medicine Amsterdam Cardiovascular Sciences Amsterdam University Medical Centre University of Amsterdam The Netherlands.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'DeMicco', 'Affiliation': '3 Pfizer New York NY.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Waters', 'Affiliation': '4 Division of Cardiology San Francisco General Hospital San Francisco CA.'}]",Journal of the American Heart Association,['10.1161/JAHA.118.010827']
262,32293965,Re: Pelvic Floor Muscle Training in Radical Prostatectomy: A Randomized Controlled Trial of the Impacts on Pelvic Floor Muscle Function and Urinary Incontinence.,,2020,,['Radical Prostatectomy'],['Re: Pelvic Floor Muscle Training'],['Pelvic Floor Muscle Function and Urinary Incontinence'],"[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}]",,0.0315816,,"[{'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Wein', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001059.03']
263,31462757,Sprint interval training versus moderate-intensity continuous training during inpatient rehabilitation after spinal cord injury: a randomized trial.,"STUDY DESIGN


Randomized trial.
OBJECTIVES


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


Inpatient rehabilitation.
METHODS


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


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


Five weeks of SIT improved physical capacity to the same extent as MICT in individuals with sub-acute SCI, despite a significantly lower time commitment with SIT.",2020,"Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524).","['inpatient rehabilitation after spinal cord injury', 'Individuals with SCI (N\u2009', 'Inpatient rehabilitation', '20; 9 tetraplegia/11 paraplegia; time since injury, 14-182 days; age, 46\u2009±\u200916 years; 15\u2009M/5\u2009F', 'individuals with sub-acute spinal cord injury (SCI']","['MICT', 'SIT or moderate-intensity continuous training (MICT', 'Sprint interval training versus moderate-intensity continuous training', '5-week sprint interval training (SIT) protocol']","['sub-maximal power output', 'Exercise enjoyment, exercise self-efficacy, and pain', ""Heart rate and Borg's Rating of Perceived Exertion"", 'Peak power output', 'heart rate', 'physical capacity', 'exercise enjoyment', 'peripheral RPE', 'exercise self-efficacy', 'central RPE']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}, {'cui': 'C0449246', 'cui_str': 'Time since injury (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}]","[{'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",780.0,0.0764155,"Peak power output increased significantly with training (36%), with no difference between groups (39% vs. 33%; p = 0.524).","[{'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Mcleod', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Herrington', 'Initials': 'H', 'LastName': 'Diana', 'Affiliation': 'Regional Rehabilitation Centre, Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'Hicks', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada. hicksal@mcmaster.ca.'}]",Spinal cord,['10.1038/s41393-019-0345-6']
264,31471527,First pass effect with contact aspiration and stent retrievers in the Aspiration versus Stent Retriever (ASTER) trial.,"BACKGROUND


The 'first pass effect' (FPE), which was originally described with stent retrievers, designates a (near-)complete revascularization obtained after a single device pass with no rescue therapy, and is associated with improved clinical outcome and decreased mortality.
OBJECTIVE


We report the rate and benefits of FPE in the Aspiration versus Stent Retriever (ASTER) trial.
MATERIALS AND METHODS


ASTER is a randomized trial comparing angiographic revascularization with the stent retriever (SR) and contact aspiration (CA) thrombectomy techniques, assessed by an external core laboratory using the modified Thrombolysis in Cerebral Infarction (mTICI) scale. Rates of FPE (defined by mTICI 2c/3 after a single pass with no rescue therapy) were compared between patients treated with SR and CA techniques. Outcomes were compared between FPE-SR and FPE-CA patients, and between FPE and non-FPE patients.
RESULTS


FPE was achieved in 97/336 patients (28.9%), with no significant difference between SR and CA (respectively 53/169 patients (31.3%) vs 44/167 patients (26.3%), adjusted RR for CA versus SR 0.84, 95% CI 0.54 to 1.31; p=0.44). After prespecified adjustment for allocated arm and randomization stratification factors, FPE in patients was associated with a significantly improved clinical outcome and a decreased mortality, and a significantly lower rate of hemorrhagic transformation and procedural complications than in non-FPE patients.
CONCLUSION


In the ASTER trial, similar rates of FPE were achieved with SR and CA, and FPE was associated with a significantly improved outcome. New techniques and devices to improve the rate of FPE are warranted.
TRIAL REGISTRATION NUMBER


Unique identifier: NCT02523261.",2020,"RESULTS


FPE was achieved in 97/336 patients (28.9%), with no significant difference between SR and CA (respectively 53/169 patients (31.3%) vs 44/167 patients (26.3%), adjusted RR for CA versus SR 0.84, 95% CI 0.54 to 1.31; p=0.44).",[],"['angiographic revascularization with the stent retriever (SR) and contact aspiration (CA) thrombectomy techniques', 'FPE']","['rates of FPE', 'mortality', 'Cerebral Infarction (mTICI) scale', 'SR and CA', 'Rates of FPE', 'hemorrhagic transformation and procedural complications']",[],"[{'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0324426', 'cui_str': 'Retriever'}, {'cui': 'C4045995', 'cui_str': 'Aspiration Thrombectomy'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0007785', 'cui_str': 'Cerebral Infarction'}, {'cui': 'C0222045'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C1141861', 'cui_str': 'Periprocedural complication'}]",,0.130885,"RESULTS


FPE was achieved in 97/336 patients (28.9%), with no significant difference between SR and CA (respectively 53/169 patients (31.3%) vs 44/167 patients (26.3%), adjusted RR for CA versus SR 0.84, 95% CI 0.54 to 1.31; p=0.44).","[{'ForeName': 'Célina', 'Initials': 'C', 'LastName': 'Ducroux', 'Affiliation': 'Department of Interventional Neuroradiology, Fondation Ophtalmologique Adolphe de Rothschild, Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Piotin', 'Affiliation': 'Department of Interventional Neuroradiology, Fondation Ophtalmologique Adolphe de Rothschild, Paris, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Gory', 'Affiliation': 'Department of Neuroradiology, Centre Hospitalier Universitaire de Nancy, Nancy, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Department of Biostatistics, EA 2694-Santé Publique,Epidémiologie et Qualité des Soins, CHU Lille, Lille, France.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Blanc', 'Affiliation': 'Department of Interventional Neuroradiology, Fondation Ophtalmologique Adolphe de Rothschild, Paris, France.'}, {'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Ben Maacha', 'Affiliation': 'Department of Interventional Neuroradiology, Fondation Ophtalmologique Adolphe de Rothschild, Paris, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lapergue', 'Affiliation': 'Department of Stroke Center, Foch Hospital, Suresnes, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fahed', 'Affiliation': 'Department of Interventional Neuroradiology, Fondation Ophtalmologique Adolphe de Rothschild, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2019-015215']
265,31612956,Cannabis and Alcohol Co-Use in a Smoking Cessation Pharmacotherapy Trial for Adolescents and Emerging Adults.,"INTRODUCTION


The co-use of cannabis and alcohol among tobacco-using youth is common. Alcohol co-use is associated with worse tobacco cessation outcomes, but results are mixed regarding the impact of cannabis on tobacco outcomes and if co-use leads to increased use of non-treated substances. This secondary analysis from a youth smoking cessation trial aimed to (1) evaluate the impact of cannabis or alcohol co-use on smoking cessation, (2) examine changes in co-use during the trial, and (3) explore secondary effects of varenicline on co-use.
METHODS


The parent study was a 12-week, randomized clinical trial of varenicline for smoking cessation among youth (ages 14-21, N = 157; Mage = 19, 40% female; 76% White). Daily cigarette, cannabis, and alcohol use data were collected via daily diaries during treatment and Timeline Follow-back for 14 weeks post-treatment.
RESULTS


Baseline cannabis co-users (68%) had double the odds of continued cigarette smoking throughout the trial compared with noncannabis users, which was pronounced in males and frequent cannabis users. Continued smoking during treatment was associated with higher probability of concurrent cannabis use. Baseline alcohol co-users (80%) did not have worse smoking outcomes compared with nonalcohol users, but continued smoking was associated with higher probability of concurrent drinking. Varenicline did not affect co-use.
CONCLUSIONS


Inconsistent with prior literature, results showed that alcohol co-users did not differ in smoking cessation, whereas cannabis co-users had poorer cessation outcomes. Youth tobacco treatment would benefit from added focus on substance co-use, particularly cannabis, but may need to be tailored appropriately to promote cessation.
IMPLICATIONS


Among youth cigarette smokers enrolled in a pharmacotherapy evaluation clinical trial, alcohol and/or cannabis co-use was prevalent. The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation. Reductions in smoking were accompanied by concurrent reductions in alcohol or cannabis use. Substance co-use does not appear to affect all youth smokers in the same manner and treatment strategies may need to be tailored appropriately for those with lower odds of smoking cessation.",2020,"The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation.","['youth cigarette smokers', 'Adolescents and Emerging Adults', 'smoking cessation among youth (ages 14-21, N = 157; Mage = 19, 40% female; 76% White']","['varenicline', 'cannabis or alcohol co-use', 'Varenicline']",['cigarette smoking'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}]",,0.0318818,"The co-use of cannabis affected smoking cessation outcomes, but more so for males and frequent cannabis users, whereas alcohol co-use did not affect smoking cessation.","[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Caitlyn O', 'Initials': 'CO', 'LastName': 'Hood', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Squeglia', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz170']
266,31841354,Capivasertib Plus Paclitaxel Versus Placebo Plus Paclitaxel As First-Line Therapy for Metastatic Triple-Negative Breast Cancer: The PAKT Trial.,"PURPOSE


The phosphatidylinositol 3-kinase (PI3K)/AKT signaling pathway is frequently activated in triple-negative breast cancer (TNBC). The AKT inhibitor capivasertib has shown preclinical activity in TNBC models, and drug sensitivity has been associated with activation of PI3K or AKT and/or deletions of PTEN. The PAKT trial was designed to evaluate the safety and efficacy of adding capivasertib to paclitaxel as first-line therapy for TNBC.
PATIENTS AND METHODS


This double-blind, placebo-controlled, randomized phase II trial recruited women with untreated metastatic TNBC. A total of 140 patients were randomly assigned (1:1) to paclitaxel 90 mg/m 2  (days 1, 8, 15) with either capivasertib (400 mg twice daily) or placebo (days 2-5, 9-12, 16-19) every 28 days until disease progression or unacceptable toxicity. The primary end point was progression-free survival (PFS). Secondary end points included overall survival (OS), PFS and OS in the subgroup with  PIK3CA / AKT1 / PTEN  alterations, tumor response, and safety.
RESULTS


Median PFS was 5.9 months with capivasertib plus paclitaxel and 4.2 months with placebo plus paclitaxel (hazard ratio [HR], 0.74; 95% CI, 0.50 to 1.08; 1-sided  P  = .06 [predefined significance level, 1-sided  P  = .10]). Median OS was 19.1 months with capivasertib plus paclitaxel and 12.6 months with placebo plus paclitaxel (HR, 0.61; 95% CI, 0.37 to 0.99; 2-sided  P  = .04). In patients with  PIK3CA / AKT1 / PTEN -altered tumors (n = 28), median PFS was 9.3 months with capivasertib plus paclitaxel and 3.7 months with placebo plus paclitaxel (HR, 0.30; 95% CI, 0.11 to 0.79; 2-sided  P  = .01). The most common grade ≥ 3 adverse events in those treated with capivasertib plus paclitaxel versus placebo plus paclitaxel, respectively, were diarrhea (13%  v  1%), infection (4%  v  1%), neutropenia (3%  v  3%), rash (4%  v  0%), and fatigue (4%  v  0%).
CONCLUSION


Addition of the AKT inhibitor capivasertib to first-line paclitaxel therapy for TNBC resulted in significantly longer PFS and OS. Benefits were more pronounced in patients with  PIK3CA / AKT1 / PTEN -altered tumors. Capivasertib warrants further investigation for treatment of TNBC.",2020,Benefits were more pronounced in patients with  PIK3CA / AKT1 / PTEN,"['women with untreated metastatic TNBC', 'Metastatic Triple-Negative Breast Cancer', 'A total of 140 patients']","['placebo plus paclitaxel', 'capivasertib (400 mg twice daily) or placebo', 'paclitaxel', 'placebo', 'Capivasertib Plus Paclitaxel Versus Placebo Plus Paclitaxel', 'PTEN']","['diarrhea', 'neutropenia', 'fatigue', 'infection', 'median PFS', 'rash', 'safety and efficacy', 'PFS and OS', 'overall survival (OS), PFS and OS in the subgroup with  PIK3CA / AKT1 / PTEN  alterations, tumor response, and safety', 'Median OS', 'progression-free survival (PFS', 'Median PFS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",140.0,0.27384,Benefits were more pronounced in patients with  PIK3CA / AKT1 / PTEN,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Jacinta', 'Initials': 'J', 'LastName': 'Abraham', 'Affiliation': 'Velindre National Health Service (NHS) Trust, Cardiff, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Wheatley', 'Affiliation': 'Royal Cornwall Hospitals NHS Trust, Truro, United Kingdom.'}, {'ForeName': 'Adrian Murray', 'Initials': 'AM', 'LastName': 'Brunt', 'Affiliation': 'University Hospitals of North Midlands NHS Trust, Stoke-on-Trent, United Kingdom.'}, {'ForeName': 'Gia', 'Initials': 'G', 'LastName': 'Nemsadze', 'Affiliation': 'Institute of Clinical Oncology, Tbilisi, Georgia.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Baird', 'Affiliation': 'Cancer Research UK Cambridge Centre, Cambridge, United Kingdom.'}, {'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Centre, Seoul, Republic of Korea.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Hall', 'Affiliation': 'Edinburgh Cancer Research Centre, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Perren', 'Affiliation': 'Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Stein', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, University College London, London, United Kingdom.'}, {'ForeName': 'László', 'Initials': 'L', 'LastName': 'Mangel', 'Affiliation': 'Institute of Oncology, Medical University of Pécs, Pecs, Hungary.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Ferrero', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Phillips', 'Affiliation': 'Barts Hospital NHS Trust, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Conibear', 'Affiliation': 'Barts Hospital NHS Trust, London, United Kingdom.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': 'Ramon y Cajal University Hospital, Madrid, Spain.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Foxley', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Elza C', 'Initials': 'EC', 'LastName': 'de Bruin', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McEwen', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stetson', 'Affiliation': 'AstraZeneca, Waltham, MA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Dougherty', 'Affiliation': 'AstraZeneca, Waltham, MA.'}, {'ForeName': 'Shah-Jalal', 'Initials': 'SJ', 'LastName': 'Sarker', 'Affiliation': 'Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Prendergast', 'Affiliation': 'Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'McLaughlin-Callan', 'Affiliation': 'Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Burgess', 'Affiliation': 'Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Lawrence', 'Affiliation': 'Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Cartwright', 'Affiliation': 'Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Mousa', 'Affiliation': 'Barts ECMC, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Turner', 'Affiliation': 'Institute of Cancer Research, London, United Kingdom.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00368']
267,32289696,Effectiveness of cathodal tDCS of the primary motor or sensory cortex in migraine: A randomized controlled trial.,"OBJECTIVES


Transcranial Direct Current Stimulation (tDCS) is a new technology that is extensively used for migraine treatment. The present study aims to examine the effectiveness of cathodal-tDCS (c-tDCS) in decreasing migraine pain frequency, duration, and intensity at the right primary motor cortex (M 1 ) or sensory cortex (S 1 ) in individuals with episodic or chronic migraine.
METHODS


The present study has a randomized, single-blind, and sham-controlled design. It tests the effectiveness of 22 sessions of c-tDCS (20min/1000 μA) in 45 migraine patients (episodic = 35; chronic = 10/with aura = 28; without aura = 17). Spread over 10 consecutive weeks, the sessions started with three sessions per week and ended with one session per week. Participants were tested at the baseline, at the end of intervention, and at 12-month follow-up. The migraine diagnosis was based on criteria set by International Headache Society (IHS) and patients were allocated to two experimental (n m1  = 15; n s1  = 15) and a sham intervention group (n c  = 15).
RESULTS


The results of a series of MANCOVAs showed a significant reduction (p < 0.05) in all hypothesized symptoms of migraine pain in both experimental groups compared to the sham intervention group at the posttest and follow-up.
CONCLUSION


The application of c-tDCS to M 1  or S 1  can be used as a technological intervention for the prophylactic and therapeutic treatment of episodic or chronic migraine.
ETHICAL COMMITTEE REGISTRATION NUMBER


Ir.mums.fm.rec.1396.362.",2020,"The results of a series of MANCOVAs showed a significant reduction (p < 0.05) in all hypothesized symptoms of migraine pain in both experimental groups compared to the sham intervention group at the posttest and follow-up.
","['individuals with episodic or chronic migraine', 'migraine', '45 migraine patients (episodic\xa0=\xa035; chronic\xa0=\xa010/with aura\xa0=\xa028; without aura\xa0=\xa017']","['cathodal-tDCS (c-tDCS', 'cathodal tDCS', 'c-tDCS (20min/1000\xa0μA', 'Transcranial Direct Current Stimulation (tDCS']","['migraine pain frequency, duration, and intensity at the right primary motor cortex (M 1 ) or sensory cortex (S 1 ', 'migraine pain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0236018', 'cui_str': 'Aura'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0528520', 'cui_str': 'M-1 compound'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}]",45.0,0.0293464,"The results of a series of MANCOVAs showed a significant reduction (p < 0.05) in all hypothesized symptoms of migraine pain in both experimental groups compared to the sham intervention group at the posttest and follow-up.
","[{'ForeName': 'Mohammad Dawood', 'Initials': 'MD', 'LastName': 'Rahimi', 'Affiliation': 'School of Education and Psychology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Javad Salehi', 'Initials': 'JS', 'LastName': 'Fadardi', 'Affiliation': 'School of Education and Psychology, Ferdowsi University of Mashhad, Mashhad, Iran; School of Community and Global Health, Claremont Graduate University, USA; School of Psychology, Bangor University, UK. Electronic address: j.s.fadardi@um.ac.ir.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Saeidi', 'Affiliation': 'Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Imanolla', 'Initials': 'I', 'LastName': 'Bigdeli', 'Affiliation': 'School of Education and Psychology, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Rohollah', 'Initials': 'R', 'LastName': 'Kashiri', 'Affiliation': 'Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Brain stimulation,['10.1016/j.brs.2020.02.012']
268,32289715,"A randomized, double blind, sham-controlled trial of repetitive transcranial magnetic stimulation (rTMS) in the treatment of negative symptoms in schizophrenia.","BACKGROUND


Research has implicated hypofrontality in the pathogenesis of Negative symptoms of schizophrenia.These symptoms are often resistant to treatment. Repetitive Transcranial Magnetic Stimulation (rTMS) has been shown to reverse this hypofrontality. Higher frequency rTMS has shown better promise, but so far there has been very little research in this area.
OBJECTIVE


We aimed to evaluate the efficacy of high-frequency (20 Hz) unilateral rTMS over the left Dorso-Lateral Pre-frontal Cortex (DLPFC) in the improvement of Negative symptoms in Schizophrenia.
METHODS


100 patients of schizophrenia with predominantly negative symptoms, were enrolled for this randomized, sham-controlled, double-blind trial.Each participant received 20 sessions of rTMS at 20 Hz frequency and 100% motor threshold, via either the active or the sham coil, over 4 weeks. A total of 2000 pulses were imparted in 10 trains per session. Negative symptoms were assessed with the SANS and PANSS. CDSS was used to rule out depressive symptoms. Assessments were carried out at baseline, post-intervention, and 1-month, 2-months, 3-months and 4-months follow ups.
RESULTS


The improvement in the negative symptoms (Anhedonia, Alogia, Avolition, Attention impairment) in active group was statistically significant at 0.01 and 0.05 (p-value) as compared to sham group.
CONCLUSIONS


These results suggest that high-frequency rTMS may lead to improvement in negative symptoms of schizophrenia. It may be worth considering its use as an adjunct to pharmacological treatment of negative symptoms.",2020,"The improvement in the negative symptoms (Anhedonia, Alogia, Avolition, Attention impairment) in active group was statistically significant at 0.01 and 0.05 (p-value) as compared to sham group.
","['negative symptoms in schizophrenia', '100 patients of schizophrenia with predominantly negative symptoms']","['Repetitive Transcranial Magnetic Stimulation (rTMS', 'high-frequency (20\xa0Hz) unilateral rTMS', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'CDSS']","['Negative symptoms', 'negative symptoms (Anhedonia, Alogia, Avolition, Attention impairment']","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0003537', 'cui_str': 'Aphasia'}, {'cui': 'C3495892', 'cui_str': 'Avolition'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",2000.0,0.346504,"The improvement in the negative symptoms (Anhedonia, Alogia, Avolition, Attention impairment) in active group was statistically significant at 0.01 and 0.05 (p-value) as compared to sham group.
","[{'ForeName': 'Nand', 'Initials': 'N', 'LastName': 'Kumar', 'Affiliation': 'All India Institute of Medical Sciences, Delhi, India. Electronic address: nandkm2001@gmail.com.'}, {'ForeName': 'Sreenivas', 'Initials': 'S', 'LastName': 'Vishnubhatla', 'Affiliation': 'Department of Bio Statistics, AIIMS, Delhi, India.'}, {'ForeName': 'Ashima Nehra', 'Initials': 'AN', 'LastName': 'Wadhawan', 'Affiliation': 'Cardio Neuro Centre, AIIMS, Delhi, India.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Minhas', 'Affiliation': 'Department of Psychiatry AIIMS, Delhi, India.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Department of Psychiatry AIIMS, Delhi, India.'}]",Brain stimulation,['10.1016/j.brs.2020.02.016']
269,32289719,Utilizing transcranial direct current stimulation to enhance laparoscopic technical skills training: A randomized controlled trial.,"BACKGROUND


Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that delivers constant, low electrical current resulting in changes to cortical excitability. Prior work suggests it may enhance motor learning giving it the potential to augment surgical technical skill acquisition.
OBJECTIVES


The aim of this study was to test the efficacy of tDCS, coupled with motor skill training, to accelerate laparoscopic skill acquisition in a pre-registered (NCT03083483), double-blind and placebo-controlled study. We hypothesized that relative to sham tDCS, active tDCS would accelerate the development of laparoscopic technical skills, as measured by the Fundamentals of Laparoscopic Surgery (FLS) Peg Transfer task quantitative metrics.
METHODS


In this study, sixty subjects (mean age 22.7 years with 42 females) were randomized into sham or active tDCS in either bilateral primary motor cortex (bM1) or supplementary motor area (SMA) electrode configurations. All subjects practiced the FLS Peg Transfer Task during six 20-min training blocks, which were preceded and followed by a single trial pre-test and post-test. The primary outcome was changes in laparoscopic skill performance over time, quantified by group differences in completion time from pre-test to post-test and learning curves developed from a calculated score accounting for errors.
RESULTS


Learning curves calculated over the six 20-min training blocks showed significantly greater improvement in performance for the bM1 group than the sham group (t = 2.07, p = 0.039), with the bM1 group achieving approximately the same amount of improvement in 4 blocks compared to the 6 blocks required of the sham group. The SMA group also showed greater mean improvement than sham, but exhibited more variable learning performance and differences relative to sham were not significant (t = 0.85, p = 0.400). A significant main effect was present for pre-test versus post-test times (F = 133.2, p < 0.001), with lower completion times at post-test, however these did not significantly differ for the training groups.
CONCLUSION


Laparoscopic skill training with active bilateral tDCS exhibited significantly greater learning relative to sham. The potential for tDCS to enhance the training of surgical skills, therefore, merits further investigation to determine if these preliminary results may be replicated and extended.",2020,"RESULTS


Learning curves calculated over the six 20-min training blocks showed significantly greater improvement in performance for the bM1 group than the sham group (t = 2.07, p = 0.039), with the bM1 group achieving approximately the same amount of improvement in 4 blocks compared to the 6 blocks required of the sham group.",['sixty subjects (mean age 22.7 years with 42 females'],"['sham or active tDCS in either bilateral primary motor cortex (bM1) or supplementary motor area (SMA) electrode configurations', 'motor skill training', 'Transcranial direct current stimulation (tDCS', 'placebo', 'tDCS', 'Laparoscopic Surgery (FLS', 'Utilizing transcranial direct current stimulation']","['performance', 'variable learning performance', 'laparoscopic skill performance over time, quantified by group differences in completion time from pre-test to post-test and learning curves', 'laparoscopic skill acquisition']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",60.0,0.44273,"RESULTS


Learning curves calculated over the six 20-min training blocks showed significantly greater improvement in performance for the bM1 group than the sham group (t = 2.07, p = 0.039), with the bM1 group achieving approximately the same amount of improvement in 4 blocks compared to the 6 blocks required of the sham group.","[{'ForeName': 'Morgan L', 'Initials': 'ML', 'LastName': 'Cox', 'Affiliation': 'Department of Surgery, Duke University, Durham, NC, USA. Electronic address: morgan.cox@duke.edu.'}, {'ForeName': 'Zhi-De', 'Initials': 'ZD', 'LastName': 'Deng', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA; Noninvasive Neuromodulation Unit, Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Palmer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Watts', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Lysianne', 'Initials': 'L', 'LastName': 'Beynel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Young', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA; Noninvasive Neuromodulation Unit, Experimental Therapeutics and Pathophysiology Branch, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Migaly', 'Affiliation': 'Department of Surgery, Duke University, Durham, NC, USA.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Appelbaum', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.03.009']
270,31800425,Comparison of Topical and Intravenous Tranexamic Acid for Total Knee Replacement: A Randomized Double-Blinded Controlled Study of Effects on Tranexamic Acid Levels and Thrombogenic and Inflammatory Marker Levels.,"BACKGROUND


Tranexamic acid (TXA) is an antifibrinolytic drug. Topical administration of TXA during total knee arthroplasty (TKA) is favored for certain patients because of concerns about thrombotic complications, despite a lack of supporting literature. We compared local and systemic levels of thrombogenic markers, interleukin (IL)-6, and TXA between patients who received intravenous (IV) TXA and those who received topical TXA.
METHODS


Seventy-six patients scheduled for TKA were enrolled in this randomized double-blinded study. The IV group received 1.0 g of IV TXA before tourniquet inflation and again 3 hours later; a topical placebo was administered 5 minutes before final tourniquet release. The topical group received an IV placebo before tourniquet inflation and again 3 hours later; 3.0 g of TXA was administered topically 5 minutes before final tourniquet release. Peripheral and wound blood samples were collected to measure levels of plasmin-anti-plasmin (PAP, a measure of fibrinolysis), prothrombin fragment 1.2 (PF1.2, a marker of thrombin generation), IL-6, and TXA.
RESULTS


At 1 hour after tourniquet release, systemic PAP levels were comparable between the IV group (after a single dose of IV TXA) and the topical group. At 4 hours after tourniquet release, the IV group had lower systemic PAP levels than the topical group (mean and standard deviation, 1,117.8 ± 478.9 µg/L versus 1,280.7 ± 646.5 µg/L; p = 0.049), indicative of higher antifibrinolytic activity after the second dose. There was no difference in PF1.2 levels between groups, indicating that there was no increase in thrombin generation. The IV group had higher TXA levels at all time points (p < 0.001). Four hours after tourniquet release, wound blood IL-6 and TXA levels were higher than systemic levels in both groups (p < 0.001). Therapeutic systemic TXA levels (mean, 7.2 ± 7.4 mg/L) were noted in the topical group. Calculated blood loss and the length of the hospital stay were lower in the IV group (p = 0.026 and p = 0.025).
CONCLUSIONS


Given that therapeutic levels were reached with topical TXA and the lack of a major difference in the mechanism of action, coagulation, and fibrinolytic profile between topical TXA and a single dose of IV TXA, it may be a simpler protocol for institutions to adopt the use of a single dose of IV TXA when safety is a concern.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2019,"Calculated blood loss and the length of the hospital stay were lower in the IV group (p = 0.026 and p = 0.025).
","['Seventy-six patients scheduled for TKA', 'Total Knee Replacement', 'total knee arthroplasty (TKA']","['Tranexamic acid (TXA', 'IV TXA', 'IV placebo', 'intravenous (IV) TXA', 'topical placebo', 'Topical and Intravenous Tranexamic Acid', 'topical TXA', 'TXA']","['thrombin generation', 'antifibrinolytic activity', 'local and systemic levels of thrombogenic markers, interleukin (IL)-6, and TXA', 'higher TXA levels', 'wound blood IL-6 and TXA levels', 'systemic PAP levels', 'Peripheral and wound blood samples', 'mechanism of action, coagulation, and fibrinolytic profile', 'Calculated blood loss and the length of the hospital stay', 'Therapeutic systemic TXA levels', 'PF1.2 levels', 'Tranexamic Acid Levels and Thrombogenic and Inflammatory Marker Levels', 'levels of plasmin-anti-plasmin (PAP, a measure of fibrinolysis), prothrombin fragment 1.2 (PF1.2, a marker of thrombin generation), IL-6, and TXA']","[{'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0863178', 'cui_str': 'Thrombin'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0003304', 'cui_str': 'Antifibrinolysins'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0005768'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1524059', 'cui_str': 'mode of action'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0016016', 'cui_str': 'fibrinolysin'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0072436', 'cui_str': 'prothrombin activation fragment F1+2'}]",76.0,0.330857,"Calculated blood loss and the length of the hospital stay were lower in the IV group (p = 0.026 and p = 0.025).
","[{'ForeName': 'Kethy M', 'Initials': 'KM', 'LastName': 'Jules-Elysee', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Tseng', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Sculco', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Lila R', 'Initials': 'LR', 'LastName': 'Baaklini', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'McLawhorn', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Pickard', 'Affiliation': 'Donald B. and Catherine C. Marron Cancer Metabolism Center, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'WeiGe', 'Initials': 'W', 'LastName': 'Qin', 'Affiliation': 'Donald B. and Catherine C. Marron Cancer Metabolism Center, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Cross', 'Affiliation': 'Donald B. and Catherine C. Marron Cancer Metabolism Center, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Edwin P', 'Initials': 'EP', 'LastName': 'Su', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'Kara G', 'Initials': 'KG', 'LastName': 'Fields', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Mayman', 'Affiliation': 'Department of Anesthesiology, Critical Care & Pain Management (K.M.J.-E., A.T., and L.R.B.), Department of Orthopedic Surgery (T.P.S., A.S.M., E.P.S., and D.J.M.), and Biostatistics Core (K.G.F.), Hospital for Special Surgery, New York, NY.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00258']
271,32289294,Crossover to Photodynamic Therapy or Micropulse Laser After Failure of Primary Treatment of Chronic Central Serous Chorioretinopathy: The REPLACE Trial.,"PURPOSE


To assess whether chronic central serous chorioretinopathy (cCSC) patients without a complete resolution of subretinal fluid (SRF) after either half-dose photodynamic therapy (PDT) or high-density subthreshold micropulse laser (HSML) treatment may benefit from crossover treatment.
DESIGN


Multicenter prospective interventional case series.
METHODS


cCSC patients with persistent SRF at the final visit of the PLACE trial were included. Patients received crossover treatment with either half-dose PDT or HSML.
RESULTS


Thirty-two patients received PDT and 10 patients received HSML. At the first evaluation visit (6-8 weeks after treatment), 81% of patients in the PDT group had complete resolution of SRF, while none of the HSML-treated patients had complete resolution of SRF. At final visit (1 year after baseline), 78% (P = .030) and 67% (P = .109) of the patients, respectively, had a complete resolution of SRF. The mean retinal sensitivity in the PDT group increased from 21.7 dB (standard error [SE]: 0.9) to 23.4 dB (SE: 0.8) at evaluation visit 1 (P = .003), to 24.7dB (SE: 0.8) at final visit (P < .001), while there were no significant changes in the HSML group (23.7 dB [SE: 1.6] at baseline, 23.8 dB [SE: 1.4] at evaluation 1, and 23.3 dB [SE: 1.4] at final visit). The mean visual acuity and mean visual quality-of-life questionnaire score did not change significantly in both groups.
CONCLUSIONS


Crossover to half-dose PDT after previous unsuccessful HSML treatment for cCSC may lead to improved anatomic and functional endpoints, while crossover to HSML after half-dose PDT does not seem to significantly affect these endpoints.",2020,"The mean visual acuity and mean visual quality of life questionnaire score did not change significantly in both groups.
","['chronic central serous chorioretinopathy (cCSC) patients without a complete resolution of subretinal fluid (SRF) after either half-dose', 'chronic central serous chorioretinopathy', 'cCSC patients with persistent SRF at the final visit of the PLACE trial were included']","['photodynamic therapy (PDT) or high-density subthreshold micropulse laser (HSML', 'photodynamic therapy or micropulse laser', 'HSML']","['mean visual acuity and mean visual quality of life questionnaire score', 'mean retinal sensitivity', 'complete resolution of SRF']","[{'cui': 'C0730314', 'cui_str': 'Chronic central serous chorioretinopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}]",,0.0548009,"The mean visual acuity and mean visual quality of life questionnaire score did not change significantly in both groups.
","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'van Rijssen', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Elon H C', 'Initials': 'EHC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Scholz', 'Affiliation': 'Department of Ophthalmology, University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Myrte B', 'Initials': 'MB', 'LastName': 'Breukink', 'Affiliation': 'Department of Ophthalmology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Dijkman', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Petrus J H', 'Initials': 'PJH', 'LastName': 'Peters', 'Affiliation': 'Department of Ophthalmology, Bergman Clinics B.V., Velp, The Netherlands.'}, {'ForeName': 'Roula', 'Initials': 'R', 'LastName': 'Tsonaka', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'MacLaren', 'Affiliation': 'Oxford Eye Hospital, John Radcliffe Hospital, West Wing, Oxford, United Kingdom.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Downes', 'Affiliation': 'Oxford Eye Hospital, John Radcliffe Hospital, West Wing, Oxford, United Kingdom.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Fauser', 'Affiliation': 'Department of Ophthalmology, University Hospital of Cologne, Cologne, Germany; F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Camiel J F', 'Initials': 'CJF', 'LastName': 'Boon', 'Affiliation': 'Department of Ophthalmology, Leiden University Medical Center, Leiden, The Netherlands; Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: c.j.f.boon@lumc.nl.'}, {'ForeName': 'Carel B', 'Initials': 'CB', 'LastName': 'Hoyng', 'Affiliation': 'Department of Ophthalmology, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.04.007']
272,31935197,Siponimod enriches regulatory T and B lymphocytes in secondary progressive multiple sclerosis.,"BACKGROUNDSiponimod (BAF312) is a selective sphingosine-1-phosphate receptor 1 and 5 (S1PR1, S1PR5) modulator recently approved for active secondary progressive multiple sclerosis (SPMS). The immunomodulatory effects of siponimod in SPMS have not been previously described.METHODSWe conducted a multicentered, randomized, double-blind, placebo-controlled AMS04 mechanistic study with 36 SPMS participants enrolled in the EXPAND trial. Gene expression profiles were analyzed using RNA derived from whole blood with Affymetrix Human Gene ST 2.1 microarray technology. We performed flow cytometry-based assays to analyze the immune cell composition and microarray gene expression analysis on peripheral blood from siponimod-treated participants with SPMS relative to baseline and placebo during the first-year randomization phase.RESULTSMicroarray analysis showed that immune-associated genes involved in T and B cell activation and receptor signaling were largely decreased by siponimod, which is consistent with the reduction in CD4+ T cells, CD8+ T cells, and B cells. Flow cytometric analysis showed that within the remaining lymphocyte subsets there was a reduction in the frequencies of CD4+ and CD8+ naive T cells and central memory cells, while T effector memory cells, antiinflammatory Th2, and T regulatory cells (Tregs) were enriched. Transitional regulatory B cells (CD24hiCD38hi) and B1 cell subsets (CD43+CD27+) were enriched, shifting the balance in favor of regulatory B cells over memory B cells. The proregulatory shift driven by siponimod treatment included a higher proliferative potential of Tregs compared with non-Tregs, and upregulated expression of PD-1 on Tregs. Additionally, a positive correlation was found between Tregs and regulatory B cells in siponimod-treated participants.CONCLUSIONThe shift toward an antiinflammatory and suppressive homeostatic immune system may contribute to the clinical efficacy of siponimod in SPMS.TRIAL REGISTRATIONNCT02330965.",2020,"The pro-regulatory shift driven by siponimod treatment included a higher proliferative potential of Tregs compared with non-Tregs, and upregulated expression of PD-1 on Tregs.","['peripheral blood from siponimod-treated participants with SPMS relative to baseline and placebo during the first year randomization phase', '36 SPMS participants enrolled in the EXPAND trial']",['placebo'],"['CD4+ T cells, CD8+ T cells, and B cells', 'regulatory T cells and regulatory B cells', 'frequencies of CD4 and CD8 naïve T cells and central memory cells, while T effector memory cells, anti-inflammatory Th2, and T regulatory (Treg) cells', 'Gene expression profiles', 'immune-associated genes involved in T and B cell activation and receptor signaling']","[{'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C3657824', 'cui_str': '1-(4-(1-((E)-4-cyclohexyl-3-trifluoromethylbenzyloxyimino)-ethyl)-2-ethylbenzyl)-azetidine-3-carboxylic acid'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C3178914', 'cui_str': 'B-Cells, Regulatory'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0312737', 'cui_str': 'Memory cell'}, {'cui': 'C4543203', 'cui_str': 'Effector (disposition)'}, {'cui': 'C1267822', 'cui_str': 'T lymphocyte positive for both CD4 antigen and CD25 antigen'}, {'cui': 'C1956267', 'cui_str': 'Transcriptome Profiles'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}]",,0.139379,"The pro-regulatory shift driven by siponimod treatment included a higher proliferative potential of Tregs compared with non-Tregs, and upregulated expression of PD-1 on Tregs.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology. AMS04 study group.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Mills', 'Affiliation': 'Department of Neurology. AMS04 study group.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology. AMS04 study group.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Dowling', 'Affiliation': 'Department of Neurology. AMS04 study group.'}, {'ForeName': 'Caitlyn', 'Initials': 'C', 'LastName': 'Fisher', 'Affiliation': 'Department of Neurology. AMS04 study group.'}, {'ForeName': 'Britany', 'Initials': 'B', 'LastName': 'Kirch', 'Affiliation': 'Department of Neurology. AMS04 study group.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Lundy', 'Affiliation': 'Autoimmunity Center of Excellence. AMS04 study group.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Fox', 'Affiliation': 'Autoimmunity Center of Excellence. AMS04 study group.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Mao-Draayer', 'Affiliation': 'Department of Neurology. AMS04 study group.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JCI insight,['10.1172/jci.insight.134251']
273,31350585,Recovery and prognostic value of myocardial strain in ST-segment elevation myocardial infarction patients with a concurrent chronic total occlusion.,"OBJECTIVES


Global left ventricular (LV) function is routinely used to assess cardiac function; however, myocardial strain is able to identify more subtle dysfunction. We aimed to determine the recovery and prognostic value of featuring tracking (FT) cardiovascular magnetic resonance (CMR) strain in ST-segment elevation myocardial infarction (STEMI) patients with a concurrent chronic total occlusion (CTO).
METHODS


In the randomized EXPLORE trial, there was no significant difference in global LV function after percutaneous coronary intervention (PCI) of the CTO, compared with no-CTO PCI, post-STEMI. In the current study, we included 200 of the 302 EXPLORE patients with a baseline CMR, of which 180 also had 4-month follow-up (serial) CMR. Global longitudinal strain (GLS) was calculated from 3 long-axis views. Global circumferential strain (GCS) and segmental strain were calculated from 3 short-axis views (basal, mid, and apical).
RESULTS


Global strain significantly improved at 4 months (GLS ∆ - 1.8 ± 4.3%, p < 0.001; GCS ∆ - 1.7 ± 4.7%, p < 0.001); however, there was no treatment effect of CTO-PCI on strain recovery. GLS was a significant predictor for 4 months of LV ejection fraction (p = 0.006), incremental to other CMR parameters including infarct size. For mortality, infarct size remained the strongest predictor. On regional level, segmental strain independently predicted recovery in the dysfunctional segments (p < 0.001).
CONCLUSIONS


Global and segmental myocardial strains significantly improved over time, with no effect of CTO-PCI. Global strain was associated with outcome and segmental strain was an independent predictor for regional LV recovery in the dysfunctional CTO territory. Further research is needed to determine the additional prognostic value of strain beyond routine CMR parameters.
KEY POINTS


• In STEMI patients with a concurrent CTO, strain significantly improves over time, regardless of CTO-PCI. • Global strain is an independent predictor for functional recovery, incremental to infarct size, LVEF, and clinical parameters. • Segmental strain was able to predict the recovery of wall thickening, incremental to transmural extent of infarction.",2020,Global strain was associated with outcome and segmental strain was an independent predictor for regional LV recovery in the dysfunctional CTO territory.,"['ST-segment elevation myocardial infarction patients with a concurrent chronic total occlusion', '200 of the 302 EXPLORE patients with a baseline CMR, of which 180 also had 4-month follow-up (serial) CMR', 'ST-segment elevation myocardial infarction (STEMI) patients with a concurrent chronic total occlusion (CTO']",['featuring tracking (FT) cardiovascular magnetic resonance (CMR) strain'],"['Global strain', 'Global circumferential strain (GCS) and segmental strain', 'global LV function', 'Global longitudinal strain (GLS', 'LV ejection fraction']","[{'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0205113', 'cui_str': 'Circumferential (qualifier value)'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]",302.0,0.0840994,Global strain was associated with outcome and segmental strain was an independent predictor for regional LV recovery in the dysfunctional CTO territory.,"[{'ForeName': 'Joëlle', 'Initials': 'J', 'LastName': 'Elias', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. j.elias@amsterdamumc.nl.'}, {'ForeName': 'Ivo M', 'Initials': 'IM', 'LastName': 'van Dongen', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Loes P', 'Initials': 'LP', 'LastName': 'Hoebers', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Dagmar M', 'Initials': 'DM', 'LastName': 'Ouweneel', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Bimmer E P M', 'Initials': 'BEPM', 'LastName': 'Claessen', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Råmunddal', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Peep', 'Initials': 'P', 'LastName': 'Laanmets', 'Affiliation': 'North Estonia Medical Center, Tallinn, Estonia.'}, {'ForeName': 'Erlend', 'Initials': 'E', 'LastName': 'Eriksen', 'Affiliation': 'Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'René J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ioanes', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Nijveldt', 'Affiliation': 'University Medical Center St Radboud, Nijmegen, The Netherlands.'}, {'ForeName': 'Jan G', 'Initials': 'JG', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'José P S', 'Initials': 'JPS', 'LastName': 'Henriques', 'Affiliation': 'Amsterdam UMC, Heart Center, Department of Cardiology, Amsterdam Cardiovascular Sciences, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hirsch', 'Affiliation': 'Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European radiology,['10.1007/s00330-019-06338-x']
274,32289673,"Treatment of Executive Function Deficits in autism spectrum disorder with repetitive transcranial magnetic stimulation: A double-blind, sham-controlled, pilot trial.","BACKGROUND


In youth and young adults with autism spectrum disorder (ASD), executive function (EF) deficits may be a promising treatment target with potential impact on everyday functioning.
OBJECTIVE


To conduct a pilot randomized, double-blind, parallel, controlled trial evaluating repetitive transcranial magnetic stimulation (rTMS) for EF deficits in ASD.
METHOD


In Toronto, Ontario (November 2014 to June 2017), a 20-session, 4-week course of 20 Hz rTMS targeting dorsolateral prefrontal cortex (DLPFC) (90%RMT) was compared to sham stimulation in 16-35 year-olds with ASD (28 male/12 female), without intellectual disability, who had impaired everyday EF performance (n = 20 active/n = 20 sham). Outcome measures evaluated protocol feasibility and clinical effects of active vs. sham rTMS on EF performance. The moderating effect of baseline functioning was explored.
RESULTS


Of eligible participants, 95% were enrolled and 95% of randomized participants completed the protocol. Adverse events across treatment arms were mild-to-moderate. There was no significant difference between active vs. sham rTMS on EF performance. Baseline adaptive functioning moderated the effect of rTMS, such that participants with lower baseline functioning experienced significant EF improvement in the active vs. sham group.
CONCLUSIONS


Our pilot RCT demonstrated the feasibility and acceptability of using high frequency rTMS targeting DLPFC in youth and young adults with autism. No evidence for efficacy of active versus sham rTMS on EF performance was found. However, we found promising preliminary evidence of EF performance improvement following active versus sham rTMS in participants with ASD with more severe adaptive functioning deficits. Future work could focus on examining efficacy of rTMS in this higher-need population.
CLINICAL TRIAL REGISTRATION


Repetitive Transcranial Magnetic Stimulation (rTMS) for Executive Function Deficits in Autism Spectrum Disorder and Effects on Brain Structure: A Pilot Study; https://clinicaltrials.gov/ct2/show/NCT02311751?term = ameis&rank = 1; NCT02311751. The trial was funded by: an American Academy of Child and Adolescent Psychiatry (AACAP) Pilot Research Award, the Innovation Fund from the Alternate Funding Plan of the Academic Health Sciences Centres of Ontario, and an Ontario Mental Health Foundation (OMHF) Project A Grant and New Investigator Fellowship.",2020,There was no significant difference between active vs. sham rTMS on EF performance.,"['Autism Spectrum Disorder and Effects on Brain Structure', 'participants with ASD with more severe adaptive functioning deficits', 'in 16-35 year-olds with ASD (28 male/12 female), without intellectual disability, who had impaired everyday EF performance (n\xa0=\xa020 active/n\xa0=\xa020 sham', 'youth and young adults with autism', 'youth and young adults with autism spectrum disorder (ASD', 'autism spectrum disorder with']","['repetitive transcranial magnetic stimulation', '20\xa0Hz rTMS targeting dorsolateral prefrontal cortex (DLPFC) (90%RMT) was compared to sham stimulation', 'Repetitive Transcranial Magnetic Stimulation (rTMS', 'sham rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'https://clinicaltrials.gov/ct2/show/NCT02311751?term\xa0', 'rTMS']","['Adverse events', 'EF performance improvement', 'EF performance', 'EF improvement', 'feasibility and acceptability', 'protocol feasibility and clinical effects of active vs. sham rTMS on EF performance']","[{'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]",95.0,0.722945,There was no significant difference between active vs. sham rTMS on EF performance.,"[{'ForeName': 'Stephanie H', 'Initials': 'SH', 'LastName': 'Ameis', 'Affiliation': 'Centre for Brain and Mental Health, Program in Neurosciences & Mental Health, Sick Kids Research Institute, The Hospital for Sick Children, Toronto, Canada; The Margaret and Wallace McCain Centre for Child, Youth & Family Mental Health, Campbell Family Mental Health Research Institute, The Centre for Addiction and Mental Health, Toronto, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada. Electronic address: stephanie.ameis@camh.ca.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada; Temerty Centre for Therapeutic Brain Intervention, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Croarkin', 'Affiliation': 'Department of Psychiatry and Psychology, Division of Child and Adolescent Psychiatry, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Mabbott', 'Affiliation': 'Centre for Brain and Mental Health, Program in Neurosciences & Mental Health, Sick Kids Research Institute, The Hospital for Sick Children, Toronto, Canada; Department of Psychology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Meng-Chuan', 'Initials': 'MC', 'LastName': 'Lai', 'Affiliation': 'Centre for Brain and Mental Health, Program in Neurosciences & Mental Health, Sick Kids Research Institute, The Hospital for Sick Children, Toronto, Canada; The Margaret and Wallace McCain Centre for Child, Youth & Family Mental Health, Campbell Family Mental Health Research Institute, The Centre for Addiction and Mental Health, Toronto, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada; Department of Psychology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Pushpal', 'Initials': 'P', 'LastName': 'Desarkar', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada; Temerty Centre for Therapeutic Brain Intervention, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Szatmari', 'Affiliation': 'Centre for Brain and Mental Health, Program in Neurosciences & Mental Health, Sick Kids Research Institute, The Hospital for Sick Children, Toronto, Canada; The Margaret and Wallace McCain Centre for Child, Youth & Family Mental Health, Campbell Family Mental Health Research Institute, The Centre for Addiction and Mental Health, Toronto, Canada; Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada; Temerty Centre for Therapeutic Brain Intervention, Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.'}]",Brain stimulation,['10.1016/j.brs.2020.01.007']
275,32289676,Effect of repetitive transcranial magnetic stimulation on altered perception of One's own face.,"BACKGROUND


Chronic orofacial pain (COP) patients often perceive the painful face area as ""swollen"" without clinical signs; such self-reported illusions of the face are termed perceptual distortion (PD). The pathophysiological mechanisms underlying PD remain elusive.
OBJECTIVE


To test the neuromodulatory effect of repetitive transcranial magnetic stimulation (rTMS) on PD in healthy individuals, to gain insight into the cortical mechanisms underlying PD.
METHODS


PD was induced experimentally by injections of local anesthetic (LA) around the infraorbital nerve and measured as perceived size changes of the affected area. Participants were randomly allocated to inhibitory rTMS (n = 26) or sham rTMS (n = 26) group. The participants rated PD at baseline, 6 min after LA, immediately, 20 and 40 min after rTMS. The rTMS (inhibitory and sham) was applied to face (lip) representation area of primary somatosensory cortex (SI) as an intervention at 10 min after the LA, when the magnitude of PD is large. As inhibitory rTMS, continuous theta-burst stimulation paradigm (50 Hz) for 40s was employed to inhibit cortical activity.
RESULTS


We demonstrated a significant decrease in the magnitude of PD immediately and 20 min after the application of inhibitory rTMS compared with sham rTMS (P < 0.006). In two control experiments, we also showed that peripheral muscle stimulation and stimulation of a cortical region other than the lip representation area had no effect on the magnitude of the PD.
CONCLUSIONS


Inhibitory rTMS applied to a somatotopical-relevant cortical region modulates PD of the face in healthy individuals and could potentially have therapeutic implications for COP patients.",2020,We demonstrated a significant decrease in the magnitude of PD immediately and 20 min after the application of inhibitory rTMS compared with sham rTMS (P < 0.006).,"['healthy individuals', 'Chronic orofacial pain (COP) patients']","['repetitive transcranial magnetic stimulation', 'rTMS (inhibitory and sham) was applied to face (lip) representation area of primary somatosensory cortex (SI', 'inhibitory rTMS', 'sham rTMS', 'local anesthetic (LA', 'repetitive transcranial magnetic stimulation (rTMS']","['magnitude of PD', 'peripheral muscle stimulation and stimulation of a cortical region']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4546211', 'cui_str': 'Chronic orofacial pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C3496281', 'cui_str': 'Primary Somatic Sensory Area'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}]","[{'cui': 'C0449286', 'cui_str': 'Degree'}, {'cui': 'C0030976', 'cui_str': 'Distortions, Perceptual'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.0342257,We demonstrated a significant decrease in the magnitude of PD immediately and 20 min after the application of inhibitory rTMS compared with sham rTMS (P < 0.006).,"[{'ForeName': 'Simple Futarmal', 'Initials': 'SF', 'LastName': 'Kothari', 'Affiliation': 'Department of Dentistry and Oral Health, Aarhus University, Aarhus C, 8000, Denmark; Scandinavian Center for Orofacial Neurosciences (SCON), Denmark; Hammel Neurorehabilitation and University Research Clinic, Hammel, 8450, Denmark. Electronic address: simple.futarmal@dent.au.dk.'}, {'ForeName': 'Lilja Kristin', 'Initials': 'LK', 'LastName': 'Dagsdóttir', 'Affiliation': 'Department of Dentistry and Oral Health, Aarhus University, Aarhus C, 8000, Denmark; Scandinavian Center for Orofacial Neurosciences (SCON), Denmark.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Kothari', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus N, 8200, Denmark; Hammel Neurorehabilitation and University Research Clinic, Hammel, 8450, Denmark.'}, {'ForeName': 'Jakob Udby', 'Initials': 'JU', 'LastName': 'Blicher', 'Affiliation': 'CFIN, Department of Clinical Medicine, Aarhus University, Aarhus N, 8200, Denmark.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Scandinavian Center for Orofacial Neurosciences (SCON), Denmark; Department of Dental Medicine, Karolinska Institutet, Huddinge, 141 04, Sweden.'}, {'ForeName': 'Poul Erik', 'Initials': 'PE', 'LastName': 'Buchholtz', 'Affiliation': 'Department for Depression and Anxiety Disorders, Aarhus University Hospital, Aarhus N, 8200, Denmark.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Ashkanian', 'Affiliation': 'Department for Depression and Anxiety Disorders, Aarhus University Hospital, Aarhus N, 8200, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Svensson', 'Affiliation': 'Department of Dentistry and Oral Health, Aarhus University, Aarhus C, 8000, Denmark; Scandinavian Center for Orofacial Neurosciences (SCON), Denmark; Faculty of Odontology, Malmø University, Sweden.'}]",Brain stimulation,['10.1016/j.brs.2020.01.001']
276,32289681,"Repeated stimulation of the dorsolateral-prefrontal cortex improves executive dysfunctions and craving in drug addiction: A randomized, double-blind, parallel-group study.","BACKGROUND


According to the neurocognitive model of addiction, the development and maintenance of drug addiction is associated with cognitive control deficits, as well as decreased activity of prefrontal regions, especially the dorsolateral prefrontal cortex (DLPFC). This study investigated how improving executive functions (EFs) impacts methamphetamine-use disorder, which has been less explored compared to craving, but might be a central aspect for the therapeutic efficacy of DLPFC stimulation in drug addiction.
METHODS


We assessed the efficacy of 10 repeated sessions of transcranial direct current stimulation (tDCS) over the DLPFC on executive dysfunctions in methamphetamine-use disorder, and its association with craving alterations. 39 of 50 initially recruited individuals with methamphetamine-use disorder who were in the abstinent-course treatment were randomly assigned to ""active"" and ""sham"" stimulation groups in a randomized, double-blind parallel-group study. They received active (2 mA, 20 min) or sham tDCS for 10 sessions over 5 weeks. Performance on major EF tasks (e.g., working memory, inhibitory control, cognitive flexibility, and risk-taking behaviour) and craving were measured before, immediately after, and 1 month following the intervention. Participants reported abstinence from drug consumption throughout the experiment, verified by regular urine tests during the course of the study up to the follow-up measurement.
RESULTS


The group which received active DLPFC tDCS showed significantly improved task performance across all EFs immediately after and 1 month following the intervention, when compared to both pre-stimulation baseline and individuals who received sham tDCS. Similarly, a significant reduction in craving was observed immediately after and 1 month following the intervention in the active, but not sham stimulation group. A significant correlation between cognitive control improvement and craving reduction was found as well.
CONCLUSIONS


Improvement of cognitive control functions is closely associated with reduced craving. Repeated DLPFC stimulation in order to improve executive control could be a promising approach for therapeutic interventions in drug addiction. However, the observed findings require further confirmation by studies that measure relapse/consumption of the respective substances over longer follow-up measurements.",2020,"The group which received active DLPFC tDCS showed significantly improved task performance across all EFs immediately after and 1 month following the intervention, when compared to both pre-stimulation baseline and individuals who received sham tDCS.","['drug addiction', '39 of 50 initially recruited individuals with methamphetamine-use disorder who were in the abstinent-course treatment']","['active DLPFC tDCS', 'sham tDCS', 'transcranial direct current stimulation (tDCS', 'active"" and ""sham"" stimulation', 'active (2\xa0mA, 20\xa0min) or sham tDCS']","['cognitive control improvement and craving reduction', 'Performance on major EF tasks (e.g., working memory, inhibitory control, cognitive flexibility, and risk-taking behaviour) and craving', 'craving', 'task performance']","[{'cui': 'C1510472', 'cui_str': 'Drug dependence'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",50.0,0.140677,"The group which received active DLPFC tDCS showed significantly improved task performance across all EFs immediately after and 1 month following the intervention, when compared to both pre-stimulation baseline and individuals who received sham tDCS.","[{'ForeName': 'Jaber', 'Initials': 'J', 'LastName': 'Alizadehgoradel', 'Affiliation': 'Department of Clinical and Health Psychology, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Nejati', 'Affiliation': 'Department of Psychology, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Sadeghi Movahed', 'Affiliation': 'Department of Psychiatry, Ardabil University of Medical Science, Ardabil, Iran. Electronic address: f.sadeghi@arums.ac.ir.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Imani', 'Affiliation': 'Department of Clinical and Health Psychology, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Taherifard', 'Affiliation': 'Department of Psychology, Mohaghegh-Ardabili University, Ardabil, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mosayebi-Samani', 'Affiliation': 'Leibniz Research Centre for Working Environment and Human Factors, Department of Psychology and Neurosciences, Dortmund, Germany.'}, {'ForeName': 'Carmelo M', 'Initials': 'CM', 'LastName': 'Vicario', 'Affiliation': 'University of Messina, Department of Scienze Cognitive Della Formazione e Degli Studi Culturali, Messina, Italy.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Leibniz Research Centre for Working Environment and Human Factors, Department of Psychology and Neurosciences, Dortmund, Germany; University Medical Hospital Bergmannsheil, Department of Neurology, Bochum, Germany.'}, {'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Salehinejad', 'Affiliation': 'Leibniz Research Centre for Working Environment and Human Factors, Department of Psychology and Neurosciences, Dortmund, Germany; Ruhr-University Bochum, International Graduate School of Neuroscience, Bochum, Germany. Electronic address: salehinejadmohammadali@gmail.com.'}]",Brain stimulation,['10.1016/j.brs.2019.12.028']
277,31385047,No evidence of improved efficacy of covered stents over uncovered stents in percutaneous palliation of malignant hilar biliary obstruction: results of a prospective randomized trial.,"OBJECTIVE


To investigate whether covered stents show a higher efficacy than uncovered stents in percutaneous treatment of malignant hilar biliary obstruction.
METHODS


Patients with obstructive jaundice caused by an unresectable hilar malignancy were included after failed endoscopic intervention in a prospective randomized trial comparing expanded polytetrafluoroethylene and fluorinated ethylene propylene (ePTFE-FEP)-covered nitinol stents with uncovered nitinol stents. Exclusion criteria were as follows: primary tumors existing more than 3 months, a biliodigestive anastomosis, previous stenting, and a Karnofsky score of less than 50. Safety, clinical success, and adjuvant chemotherapy were compared as well as occlusion rate, patency, and survival.
RESULTS


A total of 120 patients were included. One patient was post hoc excluded. Fourteen patients who died within 7 days and one patient without patency data were excluded from patency analysis. Serious adverse events (p = 0.4), 30-day mortality (p = 0.5), and clinical success (p = 0.8) were equivalent for both stent groups. Twenty-one out of 61 (34%) patients in the covered and 24/58 (41%) in the uncovered stent groups received adjuvant chemotherapy (p = 0.5). Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8). Median patency was 229 days (95% CI 113-345) for covered stents and 130 days (95% CI 75-185) for uncovered stents (p = 0.1). Median survival in patients with covered stents was 79 days (95% CI 52-106) and with uncovered stents 92 days (95% CI 60-124) (p = 0.3).
CONCLUSION


In malignant hilar biliary obstruction, there is no evidence that ePTFE-FEP-covered stents are superior to uncovered stents in terms of safety, clinical success, adjuvant chemotherapy, patency, or survival.
KEY POINTS


• Percutaneous palliation of hilar biliary obstruction is feasible with both uncovered and covered stents. • Clinical success in terms of bilirubin decrease and adjuvant chemotherapy is achievable with both stents. • Thirty-day mortality is considerable when stenting is also offered to patients with a low performance status.",2020,Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8).,"['A total of 120 patients were included', 'Exclusion criteria were as follows: primary tumors existing more than 3\xa0months, a biliodigestive anastomosis, previous stenting, and a Karnofsky score of less than 50', 'percutaneous palliation of malignant hilar biliary obstruction', 'Patients with obstructive jaundice caused by an unresectable hilar malignancy were included after failed']","['adjuvant chemotherapy', 'expanded polytetrafluoroethylene and fluorinated ethylene propylene (ePTFE-FEP)-covered nitinol stents with uncovered nitinol stents', 'endoscopic intervention']","['Median survival', 'Safety, clinical success, and adjuvant chemotherapy', 'Occlusion rate', 'occlusion rate, patency, and survival', 'clinical success', 'Serious adverse events', 'Median patency', '30-day mortality', 'safety, clinical success, adjuvant chemotherapy, patency, or survival']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0022354', 'cui_str': 'Jaundice, Obstructive'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0382943', 'cui_str': 'poly(tetrafluoroethylene-co-hexafluoropropylene)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0068790', 'cui_str': 'nickel titanium'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",120.0,0.277257,Occlusion rate was 54% (27/50) in the covered stent group and 57% (31/54) in the uncovered stent group (p = 0.8).,"[{'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Dhondt', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium. elisabeth.dhondt@uzgent.be.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vanlangenhove', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Geboes', 'Affiliation': 'Department of Gastroenterology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Vandenabeele', 'Affiliation': 'Department of Gastroenterology, Saint-Joseph Clinic Bornem and Willebroek, Bornem, Belgium.'}, {'ForeName': 'Lien', 'Initials': 'L', 'LastName': 'Van Cauwenberghe', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Defreyne', 'Affiliation': 'Department of Vascular and Interventional Radiology, Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.'}]",European radiology,['10.1007/s00330-019-06374-7']
278,31295174,Risk Factors for Adverse Birth Outcomes in the PROMISE 1077BF/1077FF Trial.,"BACKGROUND


In the multicountry PROMISE 1077BF/1077FF trial, the risk of low birth weight (LBW; <2500 g) and preterm delivery (PTD; <37 weeks) was significantly higher among women initiating a protease inhibitor-based antiretroviral treatment (ART) regimen than those receiving ZDV alone. Among those assigned to a protease inhibitor regimen, tenofovir/emtricitabine was associated with the more severe outcomes of very LBW (<1500 g) and very PTD (<34 weeks) compared with zidovudine/lamivudine.
METHODS


We used multivariate logistic regression to further explore these treatment findings, taking into account demographic baseline clinical and postentry obstetrical factors. We evaluated individual adverse outcomes and composites that included stillbirth and early loss/spontaneous abortion.
RESULTS


Among 3333 women delivering at least 1 live infant, median maternal age at enrollment was 26 years; 661 (20%) were primiparous, and 110 (3.3%) reported at least 1 previous PTD. Seventeen percent of newborns were LBW, 1% were very LBW, 17% had PTD, and 3% had very PTD. Treatment allocation remained strongly associated with multiple adverse outcomes after controlling for other risk factors with both ART regimens exhibiting increased risk relative to ZDV alone. Other risk factors remaining significant in at least one of the multivariate models included the following: country, gestational age at entry, maternal age, maternal body mass index, previous PTD, history of alcohol use, baseline HIV viral titer, multiple gestation, and several obstetric risk factors.
CONCLUSIONS


ART effects on adverse pregnancy outcomes reported in the randomized PROMISE trial remained strongly significant even after controlling for demographic, baseline clinical, and obstetrical risk factors, which were also associated with these outcomes.",2019,Treatment allocation remained strongly associated with multiple adverse outcomes after controlling for other risk factors with both ART regimens exhibiting increased risk relative to ZDV alone.,"['3333 women delivering at least 1 live infant, median maternal age at enrollment was 26 years; 661 (20%) were primiparous, and 110 (3.3%) reported at least 1 previous PTD']","['tenofovir/emtricitabine', 'zidovudine/lamivudine']","['adverse pregnancy outcomes', 'stillbirth and early loss/spontaneous abortion', 'severe outcomes of very LBW']","[{'cui': 'C4708907', 'cui_str': '3333 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0024915', 'cui_str': 'Maternal Age'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}]","[{'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",3333.0,0.195455,Treatment allocation remained strongly associated with multiple adverse outcomes after controlling for other risk factors with both ART regimens exhibiting increased risk relative to ZDV alone.,"[{'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Sebikari', 'Affiliation': 'Clinical Department, Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Farhad', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Fenton', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Maxensia', 'Initials': 'M', 'LastName': 'Owor', 'Affiliation': 'Clinical Department, Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Jeffrey S A', 'Initials': 'JSA', 'LastName': 'Stringer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Qin', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research, Boston, MA.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Maternal and Paediatric Infectious Diseases Branch, Bethesda, MD.'}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Chi', 'Affiliation': 'Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Friday', 'Initials': 'F', 'LastName': 'Saidi', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of North Carolina (UNC) Project Lilongwe, Lilongwe, Malawi.'}, {'ForeName': 'Neetal', 'Initials': 'N', 'LastName': 'Nevrekar', 'Affiliation': 'Clinical Research Department, Byramiee Jeeieebhoy Government Medical College, Pune, India.'}, {'ForeName': 'Avy', 'Initials': 'A', 'LastName': 'Violari', 'Affiliation': 'Perinatal HIV Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Tsungai', 'Initials': 'T', 'LastName': 'Chipato', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'McIntyre', 'Affiliation': 'Anova Health Institute, Johannesburg, South Africa.'}, {'ForeName': 'Dhayendre', 'Initials': 'D', 'LastName': 'Moodley', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Clinical Medicine, Centre for AIDS Research in South Africa, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Taha E', 'Initials': 'TE', 'LastName': 'Taha', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Theron', 'Affiliation': 'Department of Obstetrics and Gynecology, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Mary Glenn', 'Initials': 'MG', 'LastName': 'Fowler', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, MD.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002072']
279,31299013,Brief Report: Routine Use of Oral PrEP in a Phase 2 Rectal Microbicide Study of Tenofovir Reduced-Glycerin 1% Gel (MTN-017).,"BACKGROUND


As daily oral preexposure prophylaxis (PrEP) becomes standard for HIV prevention, routine use of PrEP is likely to increase within clinical trials of novel preventive agents. We describe the prevalence and characteristics of participants reporting nonstudy oral PrEP use within Microbicide Trials Network-017 (MTN-017), a phase 2 trial of a rectal microbicide.
SETTING AND METHODS


One hundred ninety-five HIV-uninfected men who have sex with men and transgender women were enrolled and followed in MTN-017 across 8 sites in the United States, Thailand, South Africa, and Peru from 2013 to 2015. Nonstudy oral PrEP use was recorded on case report forms and progress notes. Characteristics of PrEP users and non-PrEP users were compared using tests of statistical significance.
RESULTS


Overall, 11% of participants reported nonstudy oral PrEP use, all from the San Francisco (SF) site, accounting for 58% (22/38) of participants enrolled in SF. There was a higher median number of sex partners reported in the past 8 weeks before enrollment among oral PrEP users vs. nonusers (7 vs. 2, P = 0.02). Most PrEP users (18/22, 82%) began PrEP treatment during screening/after enrollment, and most (19/22, 86%) decided to continue oral PrEP after study completion.
CONCLUSION


Nonstudy oral PrEP use in the first phase 2 study of tenofovir reduced-glycerin 1% gel was high at a single site in SF where community PrEP availability and use was expanding. Investigators should consider the evolving context of nonstudy oral PrEP use across trial sites when designing and interpreting trials of novel biomedical prevention modalities.",2019,"There was a higher median number of sex partners reported in the past 8 weeks before enrollment among oral PrEP users vs. nonusers (7 vs. 2, P = 0.02).","['One hundred ninety-five HIV-uninfected men who have sex with men and transgender women were enrolled and followed in MTN-017 across 8 sites in the United States, Thailand, South Africa, and Peru from 2013 to 2015']","['Tenofovir', 'tenofovir', 'preexposure prophylaxis (PrEP', 'Oral PrEP']",['median number of sex partners'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1136254', 'cui_str': 'Antimicrobial-containing product'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0031238', 'cui_str': 'Peru'}]","[{'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}]",,0.210142,"There was a higher median number of sex partners reported in the past 8 weeks before enrollment among oral PrEP users vs. nonusers (7 vs. 2, P = 0.02).","[{'ForeName': 'Albert Y', 'Initials': 'AY', 'LastName': 'Liu', 'Affiliation': 'Bridge HIV, San Francisco Department of Public Health, San Francisco, CA.'}, {'ForeName': 'Aliza', 'Initials': 'A', 'LastName': 'Norwood', 'Affiliation': 'Bridge HIV, San Francisco Department of Public Health, San Francisco, CA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Gundacker', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention/Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'Department of Psychiatry, New York State Psychiatric Institute and Columbia University, New York City, NY.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'FHI 360, Durham, NC.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Patterson', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention/Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Linda-Gail', 'Initials': 'LG', 'LastName': 'Bekker', 'Affiliation': 'Desmond Tutu HIV Centre, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Suwat', 'Initials': 'S', 'LastName': 'Chariyalertsak', 'Affiliation': 'Department of Community Medicine, Research Institute for Health Sciences (RIHES), Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Anupong', 'Initials': 'A', 'LastName': 'Chitwarakorn', 'Affiliation': 'Thailand Ministry of Public Health, Nonthaburi, Thailand.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gonzales', 'Affiliation': 'Asociacion Civil Impacta Salud y Educacion, San Miguel, Peru.'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Holtz', 'Affiliation': 'Thailand Ministry of Public Health-US CDC Collaboration, Nonthaburi, Thailand.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Mayer', 'Affiliation': 'Fenway Health, The Fenway Institute, Boston, MA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Zorrilla', 'Affiliation': 'Department of Obstetrics and Gynecology, CEMI/UPR-CTU, University of Puerto Rico, San Juan, Puerto Rico.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Buchbinder', 'Affiliation': 'Bridge HIV, San Francisco Department of Public Health, San Francisco, CA.'}, {'ForeName': 'Jeanna M', 'Initials': 'JM', 'LastName': 'Piper', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Javier R', 'Initials': 'JR', 'LastName': 'Lama', 'Affiliation': 'IMPACTA PERU Clinical Trials Unit, Asociacion Civil Impacta Salud y Educacion, Lima, Peru.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Cranston', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, PA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002066']
280,31317599,Effects of shared medical appointments compared to individual appointments in children with atopic dermatitis: A pragmatic randomized controlled trial.,"BACKGROUND


Atopic dermatitis (AD) needs intensive treatment and has a negative impact on quality of life. Shared medical appointments (SMAs) showed to be effective in clinical outcomes of chronic diseases, but little is known about the effects on children and families.
OBJECTIVE


To evaluate the effects of SMAs compared to individual appointments (IA) for children with AD and their parents on coping and clinical outcomes.
METHODS


In a pragmatic randomized controlled trial, new patients in UMC Utrecht with AD, younger than 18 years, and their parents were assigned to the SMA group or the IA group using a covariate adaptive randomization method, controlled for age. Before the intervention, 2 months (primary time-point) and 6 months thereafter, we assessed parental emotional coping (primary outcome), quality of life, anxiety about corticosteroids and patient disease activity. Patients, parents and healthcare professionals could not be blinded to group assignment.
RESULTS


Of 140 patients, enrolled in the trial, 69 patients were assigned to the SMA and 71 to the IA intervention of whom 114 completed the intervention (SMA: 49; IA: 65). After 2 months, there were no differences between SMAs and IAs in effects on emotional coping: b 0.66, 95% CI -0.7 to 2.03; P = 0.33 (mean difference: 0.30; 95% CI -1.56 to 2.16; N SMA: 11; IA: 24), quality of life, anxiety about corticosteroids and disease activity. From the initial appointment to long-term follow-up, both groups showed substantial improvements, but not significant in disease activity and significant reduction in anxiety about corticosteroids. This study is limited by a low response rate; therefore, linear mixed models and dropout analyses were performed. No serious adverse events were reported.
CONCLUSION AND CLINICAL RELEVANCE


For children with AD and their parents, there were no additional benefits of GMAs in parental emotional coping, anxiety about corticosteroids, quality of life and disease activity.
TRIAL REGISTRATION


www.ISRCTN.org, ISRCTN08506572.",2019,"For children with AD and their parents, there were no additional benefits of GMAs in parental emotional coping, anxiety about corticosteroids, quality of life and disease activity.
","['For children with AD and their parents', 'children with atopic dermatitis', 'new patients in UMC Utrecht with AD, younger than 18\xa0years, and their parents', 'children with AD and their parents on coping and clinical outcomes', '140 patients, enrolled in the trial, 69 patients were assigned to the SMA and 71 to the IA intervention of whom 114 completed the intervention (SMA: 49; IA: 65']","['SMAs', 'shared medical appointments', 'SMA']","['serious adverse events', 'disease activity', 'quality of life, anxiety about corticosteroids and disease activity', 'parental emotional coping (primary outcome), quality of life, anxiety about corticosteroids and patient disease activity', 'parental emotional coping, anxiety about corticosteroids, quality of life and disease activity', 'emotional coping', 'anxiety about corticosteroids']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1831580', 'cui_str': 'Superficial Musculo-Aponeurotic System'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",140.0,0.184808,"For children with AD and their parents, there were no additional benefits of GMAs in parental emotional coping, anxiety about corticosteroids, quality of life and disease activity.
","[{'ForeName': 'Wieneke T', 'Initials': 'WT', 'LastName': 'Zijlstra', 'Affiliation': 'Department of Dermatology and Allergology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Harmieke', 'Initials': 'H', 'LastName': 'van Os-Medendorp', 'Affiliation': 'Department of Dermatology and Allergology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Karin B', 'Initials': 'KB', 'LastName': 'Fieten', 'Affiliation': 'Department of Dermatology and Allergology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Gerben', 'Initials': 'G', 'LastName': 'Sinnema', 'Affiliation': ""Department of Pediatric Psychology and Social Work, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.""}, {'ForeName': 'Carla A F M', 'Initials': 'CAFM', 'LastName': 'Bruijnzeel-Koomen', 'Affiliation': 'Department of Dermatology and Allergology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Nicolaas P A', 'Initials': 'NPA', 'LastName': 'Zuithoff', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Monique P', 'Initials': 'MP', 'LastName': ""L'Hoir"", 'Affiliation': 'Human Nutrition, Wageningen University & Research (WUR), Wageningen, The Netherlands.'}, {'ForeName': 'Suzanne G M A', 'Initials': 'SGMA', 'LastName': 'Pasmans', 'Affiliation': 'Department of Dermatology and Allergology, University Medical Centre Utrecht, Utrecht, The Netherlands.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13416']
281,31326978,Associations of Hearing Loss and Menopausal Hormone Therapy With Change in Global Cognition and Incident Cognitive Impairment Among Postmenopausal Women.,"BACKGROUND


Hearing loss (HL) and menopausal hormone therapy (conjugated equine estrogens [CEE] and/or medroxyprogesterone acetate [MPA]) are separately associated with cognitive decline and increased risk of incident cognitive impairment. Joint effects of HL and HT could be associated with additive or synergistic decline in global cognition and risk of incident cognitive impairment among postmenopausal women.
METHODS


Using the Women's Health Initiative (WHI) Memory Study, 7,220 postmenopausal women with measures of HL, global cognition (Modified Mini-Mental State Examination score), and cognitive impairment (centrally adjudicated diagnoses of mild cognitive impairment and dementia) from 1996 to 2009. Multivariable linear mixed-effects models were used to analyze rate of change in global cognition. Accelerated failure time models were used to evaluate time to incident cognitive impairment, stratified by HT.
RESULTS


Within the CEE-Alone trial, observed adverse effects of CEE-Alone on change in global cognition did not differ by HL, and estimated joint effects of HL and CEE-Alone were not associated with incident cognitive impairment. Within the CEE+MPA trial, while HL did not independently accelerate time to cognitive impairment, the adverse effect of CEE+MPA on global cognition was heightened in older women with HL. Older women on CEE+MPA either with HL (time ratio [TR] = 0.82, 95% confidence interval [CI]: 0.71, 0.94) or with normal hearing (TR = 0.86, 95% CI: 0.76, 0.97) had faster time to cognitive impairment than those with normal hearing and placebo.
CONCLUSIONS


HL may accentuate the adverse effect of CEE+MPA, not CEE-Alone, on global cognitive decline, not incident cognitive impairment, among postmenopausal women on HT.",2020,"Joint effects of HL and HT could be associated with additive or synergistic decline in global cognition and risk of incident cognitive impairment among postmenopausal women.
","['postmenopausal women', '7,220 postmenopausal women with measures of HL, global cognition (Modified Mini- Mental State Examination score), and cognitive impairment (centrally-adjudicated diagnoses of mild cognitive impairment and dementia) from 1996-2009', 'Postmenopausal Women', 'postmenopausal women on HT', 'older women with HL', 'Older women on']","['HL and HT', 'Menopausal Hormone Therapy', 'medroxyprogesterone acetate [MPA', 'CEE+MPA']","['incident cognitive impairment', 'normal hearing', 'rate of change in global cognition', 'global cognition', 'faster time to cognitive impairment']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4304091', 'cui_str': '3MS (Modified Mini-Mental State) Examination score'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}]","[{'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.094197,"Joint effects of HL and HT could be associated with additive or synergistic decline in global cognition and risk of incident cognitive impairment among postmenopausal women.
","[{'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Armstrong', 'Affiliation': 'Laboratory of Behavioral Neuroscience, National Institute of Aging, Baltimore, Maryland.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Jiu-Chiuan', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Preventive Medicine and Neurology, Keck School of Medicine of University of Southern California, Los Angeles, California.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Masaki', 'Affiliation': 'Department of Geriatric Medicine, John A. Burns School of Medicine, University of Hawai`i Manoa, Honolulu, Hawaii.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Wactawski-Wende', 'Affiliation': 'Department of Epidemiology and Environmental Health, School of Public Health and Health Professions, University of Buffalo, New York.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.'}, {'ForeName': 'Margery L S', 'Initials': 'MLS', 'LastName': 'Gass', 'Affiliation': 'Department of Obstetrics & Gynecology, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Marcia L', 'Initials': 'ML', 'LastName': 'Stefanick', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Deal', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Frank R', 'Initials': 'FR', 'LastName': 'Lin', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Resnick', 'Affiliation': 'Laboratory of Behavioral Neuroscience, National Institute of Aging, Baltimore, Maryland.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glz173']
282,32279703,Behavioral interventions for infant sleep problems: the role of parental cry tolerance and sleep-related cognitions.,"STUDY OBJECTIVES


This study tested whether parental cry tolerance (PCT) and distress-attribution cognitions predict outcomes of behavioral interventions for infant sleep problems. It additionally examined intervention effects on these parental factors.
METHODS


Participants were 91 infants aged 9-18 months (61% boys) with sleep-related problems and their parents. Families were randomized to 1 of 2 behavioral interventions for infant sleep problems: Checking-in or Camping-out. Assessments were completed at baseline and 1-month post-treatment. Infant sleep was assessed using actigraphy and parent reports on the Brief Infant Sleep Questionnaire. PCT was measured using the Intervention Delay to Infant Crying Video laboratory paradigm, and parental distress-attribution cognitions were assessed via the Infant Sleep Vignettes Interpretation Scale.
RESULTS


Higher PCT and lower parental distress-attribution cognitions at baseline predicted greater improvement in parent-reported sleep problems post-treatment, and higher PCT additionally predicted larger reductions in the number of reported nighttime awakenings. Moreover, PCT increased, and distress-attribution decreased, following the interventions.
CONCLUSIONS


Parent factors both predict and are predicted by behavioral interventions for infant sleep problems. This study's findings suggest that parents with low cry tolerance and high distress-attribution cognitions derive less benefit from these interventions and may thus require augmented care.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: Interventions for sleep problems in early childhood; URL: https://clinicaltrials.gov/ct2/show/NCT01489215;Identifier: NCT01489215.",2020,This study tested whether parental cry tolerance (PCT) and distress-attribution cognitions predict outcomes of behavioral interventions for infant sleep problems.,"['infant sleep problems', 'Participants were 91 infants aged 9-18 months (61% boys) with sleep related problems, and their parents', 'parents with low cry tolerance and high distress-attribution cognitions']","['Behavioral interventions', 'behavioral interventions for infant sleep problems: Checking-in or Camping-out', 'behavioral interventions', 'parental cry tolerance (PCT']","['distress-attribution', 'Infant sleep', 'parental distress-attribution cognitions', 'Intervention Delay to Infant Crying Video laboratory paradigm, and parental distress-attribution cognitions', 'sleep problems']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0581876', 'cui_str': 'Crying infant'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}]",91.0,0.140445,This study tested whether parental cry tolerance (PCT) and distress-attribution cognitions predict outcomes of behavioral interventions for infant sleep problems.,"[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kahn', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Livne-Karp', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Juda-Hanael', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Haim', 'Initials': 'H', 'LastName': 'Omer', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Tikotzky', 'Affiliation': 'Department of Psychology, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Anders', 'Affiliation': 'Brown University, Providence, Rhode Island.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Sadeh', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel-Aviv, Israel.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8488']
283,31467447,"Parents of newborns in the NICU enrolled in genome sequencing research: hopeful, but not naïve.","PURPOSE


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


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


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


Parents who enrolled their newborn in a RCT of GS demonstrated awareness of a psychological risk, but generally held positive beliefs about GS and perceived the benefits outweighed the risk.",2020,The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial.,"['infants with suspected genetic disorders', 'Twenty-three of 128 parents whose infant had enrolled in the RCT completed a retrospective survey and interview addressing attitudes about GS and responses to receiving diagnostic information', 'Parents of newborns in the NICU enrolled in genome sequencing research', ""12 participants who had received a unifying diagnosis for their child's symptoms described personal utility of the information""]",[],['psychological risks of GS'],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0019247', 'cui_str': 'Hereditary Diseases'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0035168'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",128.0,0.0537586,The majority reported positive (13; 56.5%) or neutral 4 (4; 17.4%) feelings when approached about GS for their infant and 100% felt that GS was generally beneficial.,"[{'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Berrios', 'Affiliation': ""Center for Pediatric Genomic Medicine, Children's Mercy Kansas City, Kansas City, MO, USA. cdberrios@cmh.edu.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Koertje', 'Affiliation': ""Division of Developmental and Behavioral Sciences, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Noel-MacDonnell', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Soden', 'Affiliation': ""Center for Pediatric Genomic Medicine, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lantos', 'Affiliation': 'School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-019-0644-5']
284,32279841,Bioresorbable Vascular Scaffolds Versus Drug-Eluting Stents for Diffuse Long Coronary Narrowings.,"Clinical benefits of bioresorbable vascular scaffold (BVS) implantation for long coronary lesions were not sufficiently evaluated. The efficacy and safety of BVS and metallic everolimus-eluting stent (EES) were compared for the treatment of long coronary narrowings. A total of 341 patients with diffuse long lesions (requiring device length ≥28 mm) were randomized to receive either BVS (n = 171) or EES (n = 170) implantation. The primary endpoint was major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization at 12 months. The trial was terminated early because the manufacturer stopped supplying BVS. The mean lesion length was 32.2 ± 13.1 mm in the BVS group and 35.3 ± 13.0 mm in the EES group. The 12-month follow-up was completed in 332 patients (97.4%). At 12 months, the primary endpoint events occurred in 2 patients (1.2%) in the BVS group and in 4 patients (2.4%) in the EES group (hazard ratio = 0.49, 95% confidence interval = 0.09 to 2.67, p = 0.398). Definite or probable device thrombosis occurred in 1 patient (0.6%) in the BVS group and 1 patient (0.6%) in the EES group (hazard ratio = 1.00, 95% confidence interval = 0.06 to 15.94, p = 0.998). In conclusion, in patients with long native coronary artery disease, significant differences between BVS and EES were not observed regarding the primary composite endpoint of death from cardiac cause, myocardial infarction, device thrombosis, or target-lesion revascularization at 12 months. However, due to the early termination of this trial and a low number of events, the results cannot be considered clinically relevant (clinicalTrials.gov Identifier: NCT02796157).",2020,"The primary endpoint was major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization at 12 months.","['341 patients with diffuse long lesions (requiring device length ≥28 mm', 'Diffuse Long Coronary Narrowings', 'patients with long native coronary artery disease']","['BVS', 'BVS and metallic everolimus-eluting stent (EES', 'bioresorbable vascular scaffold (BVS) implantation', 'Bioresorbable Vascular Scaffolds Versus Drug-Eluting Stents', 'EES']","['BVS and EES', 'death from cardiac cause, myocardial infarction, device thrombosis, or target-lesion revascularization', 'mean lesion length', 'Definite or probable device thrombosis', 'major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0337143', 'cui_str': 'Scaffold'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",341.0,0.119129,"The primary endpoint was major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization at 12 months.","[{'ForeName': 'Jongkwon', 'Initials': 'J', 'LastName': 'Seo', 'Affiliation': 'Sanggye Paik Hospital, Inje University, Seoul, Korea.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Sung-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Do-Yoon', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Cardiac Center, Korea University Anam Hospital, Seoul, Korea.'}, {'ForeName': 'Ae-Young', 'Initials': 'AY', 'LastName': 'Her', 'Affiliation': 'Kangwon National University School of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Yong Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Kangwon National University School of Medicine, Chuncheon, Korea.'}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Young-Guk', 'Initials': 'YG', 'LastName': 'Ko', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea.'}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Heart Institute, Asan Medical Center, University of Ulsan, Seoul, Korea. Electronic address: dwpark@amc.seoul.kr.'}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, Korea. Electronic address: mkhong61@yuhs.ac.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.02.031']
285,32032692,"Efficacy and safety of apremilast in patients with moderate to severe plaque psoriasis of the scalp: Results of a phase 3b, multicenter, randomized, placebo-controlled, double-blind study.","BACKGROUND


Many patients with psoriasis are bothered by symptoms in highly visible, pruritic areas, such as the scalp.
OBJECTIVE


To evaluate the efficacy and safety of apremilast for moderate to severe scalp psoriasis.
METHODS


This phase 3b, double-blind, placebo-controlled study randomized adults with moderate to severe scalp psoriasis who had inadequate response/intolerance to at least 1 topical scalp psoriasis therapy (NCT03123471). The primary endpoint was the proportion of patients who achieved Scalp Physician Global Assessment response, defined as score of 0 (clear) or 1 (almost clear), with at least a 2-point reduction, at week 16. Secondary endpoints included at least a 4-point improvement from baseline in Whole Body Itch and Scalp Itch Numeric Rating Scales (NRSs) and mean improvement in Dermatology Life Quality Index (DLQI) at week 16.
RESULTS


There were 303 randomized patients (placebo: n = 102; apremilast: n = 201). With apremilast, significantly more patients achieved Scalp Physician Global Assessment (43.3% vs 13.7%), Scalp Itch NRS (47.1% vs 21.1%), and Whole Body Itch NRS (45.5% vs 22.5%) response, and significantly greater DLQI improvement was observed versus placebo (-6.7 vs -3.8; all P < .0001). Common adverse events with apremilast were diarrhea (30.5%), nausea (21.5%), headache (12.0%), and vomiting (5.5%).
LIMITATIONS


Patients with mild disease were not enrolled.
CONCLUSION


Apremilast showed efficacy for the treatment of moderate to severe scalp psoriasis.",2020,"With apremilast, significantly more patients achieved ScPGA (43.3% vs. 13.7%), Scalp Itch NRS (47.1% vs. 21.1%), and Whole Body Itch NRS (45.5% vs. 22.5%) response, and significantly greater DLQI improvement was observed versus placebo (-6.7 vs. -3.8; all P<0.0001).","['Patients With Moderate to Severe Plaque Psoriasis of the Scalp', 'Patients with mild disease were not enrolled', 'adults with moderate to severe scalp psoriasis who had inadequate response/intolerance to ≥1 topical scalp psoriasis therapy (NCT03123471', '303 randomized patients']","['Placebo', 'placebo']","['Whole Body Itch NRS', 'Scalp Itch NRS', 'diarrhea', 'ScPGA', 'DLQI improvement', '≥4-point improvement from baseline in Whole Body Itch and Scalp Itch numeric rating scales (NRS) and mean improvement in Dermatology Life Quality Index (DLQI', 'Efficacy and Safety', 'nausea', 'vomiting', 'headache', 'proportion of patients who achieved Scalp Physician Global Assessment (ScPGA) response, defined as score of 0 (clear) or 1 (almost clear) with ≥2-point reduction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0406326', 'cui_str': 'Scalp psoriasis (disorder)'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0231199', 'cui_str': 'Intolerance, function (observable entity)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",303.0,0.257899,"With apremilast, significantly more patients achieved ScPGA (43.3% vs. 13.7%), Scalp Itch NRS (47.1% vs. 21.1%), and Whole Body Itch NRS (45.5% vs. 22.5%) response, and significantly greater DLQI improvement was observed versus placebo (-6.7 vs. -3.8; all P<0.0001).","[{'ForeName': 'Abby S', 'Initials': 'AS', 'LastName': 'Van Voorhees', 'Affiliation': 'Eastern Virginia Medical School, Norfolk, Virginia. Electronic address: vanvooas@evms.edu.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Stein Gold', 'Affiliation': 'Henry Ford Health System, West Bloomfield, Missouri.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Strober', 'Affiliation': 'Yale University, New Haven, Connecticut; Central Connecticut Dermatology, Cromwell, Connecticut.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lynde', 'Affiliation': 'Lynde Institute for Dermatology, Markham, Ontario, Canada.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Tyring', 'Affiliation': 'Department of Dermatology, Center for Clinical Studies, University of Texas Health Science Center, Houston, Texas.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Cauthen', 'Affiliation': 'MidState Skin Institute, Ocala, Florida.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Sofen', 'Affiliation': 'Dermatology Research Associates, Los Angeles, California.'}, {'ForeName': 'Zuoshun', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Celgene Corporation, Summit, New Jersey.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Paris', 'Affiliation': 'Celgene Corporation, Summit, New Jersey.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Celgene Corporation, Summit, New Jersey.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.01.072']
286,32199790,Pregnancy intentions and contraceptive uptake after miscarriage.,"OBJECTIVE


To identify factors associated with contraceptive uptake among participants in a miscarriage management clinical trial.
STUDY DESIGN


We performed a secondary analysis of a multi-center, randomized controlled trial of medical management regimens for miscarriage between 5 and 12 completed weeks. Pregnancy intention was measured by patient report after miscarriage diagnosis. Participants were offered contraception in accordance with standard clinical care once their miscarriage was completed. We analyzed participants as a cohort and fit a multivariable model to describe demographic characteristics and pregnancy intentions independently associated with contraceptive uptake.
RESULTS


Of 244 participants with available contraceptive outcomes, 121 (50%) stated that this pregnancy was planned, and 218 (90%) stated that they had planned to continue the pregnancy to term. Ninety-seven participants (40%) initiated contraception: 33 (14%) selected a long-acting reversible method, 44 (18%) a short-acting reversible method, and 20 (8%) condoms or emergency contraception, while 147 (60%) declined contraception after miscarriage completion. In the multivariable model, unplanned pregnancy (aRR 2.13, 95% CI: 1.45-3.13) and lack of intention to continue the pregnancy (aRR 1.61, 95% CI: 1.18-2.20) were independently associated with contraceptive uptake. Of participants who declined contraception, 85 (57%) did so in order to conceive again. Nearly one-quarter of participants who declined contraception described the index pregnancy as unplanned, but after miscarriage planned to conceive a new pregnancy.
CONCLUSION


Patients with unplanned pregnancy who miscarried were twice as likely to initiate contraception as those with planned pregnancy, however pregnancy intentions sometimes changed after miscarriage.
IMPLICATIONS


Miscarriage management represents an important opportunity to clarify pregnancy goals and provide contraceptive counseling. Although unplanned pregnancy correlates with contraceptive uptake, we do not recommend using this clinically to predict contraceptive need. Future research should examine how best to measure pregnancy intention and its relationship to the experience of miscarriage.",2020,"In the multivariable model, unplanned pregnancy (aRR 2.13, 95% CI: 1.45-3.13) and lack of intention to continue the pregnancy (aRR 1.61, 95% CI: 1.18-2.20) were independently associated with contraceptive uptake.","['244 participants with available contraceptive outcomes, 121 (50', 'Ninety-seven participants (40%) initiated contraception: 33 (14%) selected a long-acting reversible method, 44 (18%) a short-acting reversible method, and 20 (8%) condoms or emergency contraception, while 147 (60%) declined contraception after miscarriage completion', 'participants in a miscarriage management clinical trial', 'Of participants who declined contraception, 85 (57%) did so in order to conceive again', 'miscarriage between 5 and 12 completed weeks']",[],"['Pregnancy intention', 'unplanned pregnancy', 'Pregnancy intentions and contraceptive uptake']","[{'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0439073', 'cui_str': '97 (qualifier value)'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0558252', 'cui_str': 'Emergency Contraception'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",[],"[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0041747', 'cui_str': 'Unintended Pregnancy'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}]",244.0,0.114047,"In the multivariable model, unplanned pregnancy (aRR 2.13, 95% CI: 1.45-3.13) and lack of intention to continue the pregnancy (aRR 1.61, 95% CI: 1.18-2.20) were independently associated with contraceptive uptake.","[{'ForeName': 'Andrea H', 'Initials': 'AH', 'LastName': 'Roe', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce St., Philadelphia, PA 19104, United States. Electronic address: andrea.roe@uphs.upenn.edu.'}, {'ForeName': 'Arden', 'Initials': 'A', 'LastName': 'McAllister', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce St., Philadelphia, PA 19104, United States.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado, 13001 E. 17th Place, B119, Bldg 500, 3rd Floor West Wing, Aurora, CO 80045, United States.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': 'Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, 3400 Spruce St., Philadelphia, PA 19104, United States.'}]",Contraception,['10.1016/j.contraception.2020.03.002']
287,32223002,Articaine efficacy and safety in young children below the age of four years: An equivalent parallel randomized control trial.,"BACKGROUND


Pain control is a mandatory aspect in pediatric dentistry office through local anesthesia.
AIM


To assess the safety and efficacy of 4% articaine local anesthetic in young children below four years old.
DESIGN


An equivalent randomized control trial with two parallel arms included 184 young children (92 per group) aged from 36 to 47 months seeking pulpotomy of mandibular primary molars which performed after buccal infiltration injection. The control group received lidocaine hydrochloride 2% with epinephrine 1:100 000. The intervention was articaine hydrochloride 4% with epinephrine 1:100 000. Children's behavior during injection and treatment have assessed using Faces, Legs, Activity, Cry, and Consolability (FLACC) and child's behavior using Frankl Behavior Rating Scale (FBRS). In addition, post-operative complications have been addressed.
RESULTS


Both anesthetic agents were equivalent during the injection phase. During the treatment phase, the absolute risk difference (ARR) between the two groups was 0.120 (95% CI: -0.003; 0.243). The maximum limit of 95% CI surpassed the margin of equivalence, indicating that less pain has been expressed during pulpotomy among children delivered articaine when compared to their counterparts in the lidocaine group. Concerning post-operative complications, no statistically significant difference was detected between the two anesthetic drugs.
CONCLUSION


The findings supported the efficient and secure use of articaine hydrochloride 4% with epinephrine 1:100 000 to treat children between the ages of 3 and below 4 years old.",2020,"Concerning postoperative complications, no statistically significant has been demonstrated between the two anesthetic drugs.
","['184 young children (92 per group) aged from 36 to 47 months seeking pulpotomy of mandibular primary molars which performed after buccal infiltration injection', 'Young Children below Age of Four Years', 'young children below four-years-old']","['articaine hydrochloride', 'lidocaine hydrochloride', 'articaine local anesthetic', 'epinephrine 1:100000', 'articaine', 'epinephrine', 'lidocaine']","[""Faces, Legs, Activity, Cry and Consolability (FLACC) and child's behavior using Frankl Behaviour Rating Scale (FBRS"", 'absolute risk difference (ARR', 'safety and efficacy', 'Articaine Efficacy and Safety']","[{'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0007300', 'cui_str': 'Articaine hydrochloride'}, {'cui': 'C0546869', 'cui_str': 'Lidocaine Hydrochloride'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0010399', 'cui_str': 'Cryings'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0475483', 'cui_str': 'Behavioral Rating Scale'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}]",184.0,0.0888032,"Concerning postoperative complications, no statistically significant has been demonstrated between the two anesthetic drugs.
","[{'ForeName': 'Ahmad Abdel Hamid', 'Initials': 'AAH', 'LastName': 'Elheeny', 'Affiliation': 'Faculty of Dentistry, Minia University, El Minia, Egypt.'}]",International journal of paediatric dentistry,['10.1111/ipd.12640']
288,31121394,Beneficial effects of Silexan on sleep are mediated by its anxiolytic effect.,"Disturbed sleep is among the most prevalent hyperarousal symptoms in anxiety disorders. Most drugs recommended for anxiety and insomnia have a sedating effect which is related to their beneficial effect on disturbed sleep. Silexan is a proprietary essential oil from Lavandula angustifolia. This drug has significant anxiolytic and sleep improving properties. Interestingly, these effects are not associated with sedation. Here we asked whether the positive effects on sleep are due to primary pharmacodynamic or secondary, disease related effects. We used the data from a double-blind, randomized study in which 212 patients were analyzed for efficacy after ten weeks' treatment with 80 mg/day Silexan or placebo. Anxiety and disturbed sleep were assessed using the Hamilton Anxiety Scale (HAMA) and the Pittsburgh Sleep Quality Index (PSQI), respectively. Regression-based mediation analysis was employed to estimate direct treatment effects and indirect effects mediated by anxiety control separately for each study group. Sobel's test was used to investigate the extent to which the mediator (HAMA change) contributes to the total effect of the independent variable (treatment) on the dependent variable (PSQI change). Compared to placebo, Silexan significantly reduced the total scores of the HAMA (p < 0.001) and of the PSQI (p = 0.002) after ten weeks, with clinically meaningful treatment group differences that were observed already after two and six weeks for HAMA and PSQI, respectively. Silexan had a statistically meaningful indirect effect on sleep (mediated by the effect on anxiety; p < 0.001) but no appreciable direct effect (p = 0.958). The ratio between the indirect and the total effect was determined to be 0.984, i. e., 98.4% of the total effect of Silexan on disturbed sleep were explained by the effect of Silexan on the symptoms of anxiety whereas 1.6% were attributable to a direct effect. The results indicate that Silexan exerts a secondary sleep improving effect almost exclusively through its anxiolytic action rather than by sedation. Findings are consistent with the drug's assumed mechanism of action.",2019,"Compared to placebo, Silexan significantly reduced the total scores of the HAMA (p < 0.001) and of the PSQI (p = 0.002) after ten weeks, with clinically meaningful treatment group differences that were observed already after two and six weeks for HAMA and PSQI, respectively.",['212 patients'],"['80\u202fmg/day Silexan or placebo', 'Silexan', 'placebo, Silexan']","['Anxiety and disturbed sleep', 'total scores of the HAMA', 'symptoms of anxiety', 'Hamilton Anxiety Scale (HAMA) and the Pittsburgh Sleep Quality Index (PSQI', 'disturbed sleep', 'sleep']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C2930445', 'cui_str': 'silexan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}]",212.0,0.078744,"Compared to placebo, Silexan significantly reduced the total scores of the HAMA (p < 0.001) and of the PSQI (p = 0.002) after ten weeks, with clinically meaningful treatment group differences that were observed already after two and six weeks for HAMA and PSQI, respectively.","[{'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zurich Lenggstrasse, 31/PO-Box 1931, 8032, Zürich, Switzerland. Electronic address: erich.seifritz@bli.uzh.ch.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Schläfke', 'Affiliation': 'Dr. Willmar Schwabe GmbH & Co. KG, Willmar-Schwabe-Straße 4, 76227, Karlsruhe, Germany. Electronic address: Sandra.Schlaefke@schwabe.de.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Holsboer-Trachsler', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center for Affective, Stress and Sleep Disorders, Wilhelm Klein-Strasse 27, 4002, Basel, Switzerland. Electronic address: edith.holsboer@gmail.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.04.013']
289,31264510,A novel approach to evaluate the pharmacodynamics of a selective dopamine D1/D5 receptor partial agonist (PF-06412562) in patients with stable schizophrenia.,"BACKGROUND


PF-06412562 is an orally bioavailable, selective dopamine D1/D5 receptor partial agonist with a non-catechol structure under evaluation for treatment of cognitive impairment in schizophrenia.
AIMS


This randomized, double-blind, placebo-controlled, parallel-group, Phase 1b study examined the pharmacokinetics and pharmacodynamics of three doses of PF-06412562 (3 mg, 9 mg, and 45 mg twice daily) over 15 days in patients with schizophrenia receiving antipsychotics.
METHODS


Primary endpoints included adjunctive safety/tolerability and effects on MATRICS Consensus Cognitive Battery Working Memory domain and reward processing (Monetary Incentive Delay) tasks. Exploratory endpoints included other behavioral/neurophysiological tasks, including the N-back task.
RESULTS


Among 95 subjects (78% male; mean age 34.8 years), baseline characteristics were similar across groups. The MATRICS Consensus Cognitive Battery Working Memory composite change from baseline on Day 13 improved in all groups, the smallest improvement was observed in the 45 mg group and was significantly smaller than that in the placebo group (two-sided  p =0.038). For the Monetary Incentive Delay task (change from baseline in blood-oxygen-level-dependent functional magnetic resonance imaging activation in anterior ventral striatum for the contrast of cue gain>cue no gain on Day 15), no PF-06412562 dose was significantly different from placebo. No doses of PF-06412562 showed a significant difference on two-back task accuracy versus placebo.
CONCLUSIONS


Adjunctive treatment with PF-06412562 was safe and well tolerated in patients with schizophrenia. PF-06412562 failed to show clinical benefit relative to placebo on assessments of cognition or reward processing in symptomatically stable patients over a 15-day treatment period. Numerous limitations due to the safety study design warrant further efficacy evaluation for this drug mechanism.",2019,PF-06412562 failed to show clinical benefit relative to placebo on assessments of cognition or reward processing in symptomatically stable patients over a 15-day treatment period.,"['patients with stable schizophrenia', 'patients with schizophrenia', 'patients with schizophrenia receiving antipsychotics', '95 subjects (78% male; mean age 34.8 years']","['selective dopamine D1/D5 receptor partial agonist (PF-06412562', 'placebo', 'PF-06412562']","['safe and well tolerated', 'cue gain', 'cognition or reward processing', 'smallest improvement', 'behavioral/neurophysiological tasks, including the N-back task', 'adjunctive safety/tolerability and effects on MATRICS Consensus Cognitive Battery Working Memory domain and reward processing (Monetary Incentive Delay) tasks']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]",95.0,0.210609,PF-06412562 failed to show clinical benefit relative to placebo on assessments of cognition or reward processing in symptomatically stable patients over a 15-day treatment period.,"[{'ForeName': 'Estibaliz', 'Initials': 'E', 'LastName': 'Arce', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Balice-Gordon', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Sridhar', 'Initials': 'S', 'LastName': 'Duvvuri', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Naylor', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Harel', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Rouba', 'Initials': 'R', 'LastName': 'Kozak', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Gray', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'DeMartinis', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119855302']
290,31125916,Internet-delivered computerized cognitive & affective remediation training for the treatment of acute and chronic posttraumatic stress disorder: Two randomized clinical trials.,"Treatment of posttraumatic stress disorder (PTSD) is time and cost-intensive. New, readily implementable interventions are needed. Two parallel randomized clinical trials tested if cognitive/affective computerized training improves cognitive/affective functions and PTSD symptoms in acute (N = 80) and chronic PTSD (N = 84). Adults age 18-65 were recruited from an Israeli hospital emergency room (acute) or from across the United States (chronic). Individuals were randomized to an active intervention (acute N = 50, chronic N = 48) that adaptively trains cognition and an affective positivity bias, or a control intervention (acute N = 30, chronic N = 36) of engaging computer games. Participants, blind to assignment, completed exercises at home for 30 min/day over 30 days (acute) or 45 min/day over 45 days (chronic). Primary outcomes were computerized cognitive/affective function metrics. Secondary outcomes were Clinician-Administered PTSD Scale (CAPS) total scores. In chronic PTSD, the active arm demonstrated facilitated speed of fearful face identification (F = 20.96, q < 0.001; d = 1.21) and a trend towards improvement in total PTSD symptoms (F = 2.91, p = 0.09, d = 0.47), which was due to improvement in re-experiencing symptoms (F = 6.14, p = 0.015; d = 0.73). Better cognitive performance at baseline moderated the training effect and was associated with more favorable improvements on both metrics. Cognitive and affective training does not have widespread benefit on symptoms and cognitive/affective functions in PTSD. Future studies targeting re-experiencing a priori, stratifying on cognitive capacity, and with modified methods to infer on mechanisms and optimized training parameters may be warranted. ClinicalTrials.gov Identifiers: NCT01694316 &NCT02085512.",2019,"In chronic PTSD, the active arm demonstrated facilitated speed of fearful face identification (F = 20.96, q < 0.001; d = 1.21) and a trend towards improvement in total PTSD symptoms (F = 2.91, p = 0.09, d = 0.47), which was due to improvement in re-experiencing symptoms (F = 6.14, p = 0.015; d = 0.73).","['acute and chronic posttraumatic stress disorder', 'posttraumatic stress disorder (PTSD', 'acute (N\u202f=\u202f80) and chronic PTSD (N\u202f=\u202f84', 'Adults age 18-65 were recruited from an Israeli hospital emergency room (acute) or from across the United States (chronic']","['active intervention (acute N\u202f=\u202f50, chronic N\u202f=\u202f48) that adaptively trains cognition and an affective positivity bias, or a control intervention (acute N\u202f=\u202f30, chronic N\u202f=\u202f36) of engaging computer games', 'cognitive/affective computerized training', 'Internet-delivered computerized cognitive & affective remediation training']","['Clinician-Administered PTSD Scale (CAPS) total scores', 'computerized cognitive/affective function metrics', 'cognitive/affective functions and PTSD symptoms', 're-experiencing symptoms', 'Better cognitive performance', 'total PTSD symptoms']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}]",,0.0491304,"In chronic PTSD, the active arm demonstrated facilitated speed of fearful face identification (F = 20.96, q < 0.001; d = 1.21) and a trend towards improvement in total PTSD symptoms (F = 2.91, p = 0.09, d = 0.47), which was due to improvement in re-experiencing symptoms (F = 6.14, p = 0.015; d = 0.73).","[{'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry, Dell Medical School, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Naomi B', 'Initials': 'NB', 'LastName': 'Fine', 'Affiliation': 'Psychological Trauma Care Center, Shaare-Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Rachael N', 'Initials': 'RN', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA; Stanford Neurosciences Institute, Stanford University, Stanford, CA, USA; Sierra Pacific Mental Illness, Research, Education, and Clinical Center (MIRECC), Veterans Affairs Palo Alto Healthcare System, Palo Alto, CA, USA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Achituv', 'Affiliation': 'Psychological Trauma Care Center, Shaare-Zedek Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Yevgeniya V', 'Initials': 'YV', 'LastName': 'Zaiko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA; Stanford Neurosciences Institute, Stanford University, Stanford, CA, USA; Sierra Pacific Mental Illness, Research, Education, and Clinical Center (MIRECC), Veterans Affairs Palo Alto Healthcare System, Palo Alto, CA, USA.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Merin', 'Affiliation': 'Trauma Unit and Department of Cardiothoracic Surgery, Shaare-Zedek Medical Center, Israel; Hebrew University Faculty of Medicine, Jerusalem, Israel.'}, {'ForeName': 'Arieh Y', 'Initials': 'AY', 'LastName': 'Shalev', 'Affiliation': 'Department of Psychiatry, New York University Langone Medical Center, New York, NY, USA. Electronic address: arieh.shalev@nyumc.org.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA; Stanford Neurosciences Institute, Stanford University, Stanford, CA, USA; Sierra Pacific Mental Illness, Research, Education, and Clinical Center (MIRECC), Veterans Affairs Palo Alto Healthcare System, Palo Alto, CA, USA. Electronic address: aetkin@stanford.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.05.007']
291,31128502,"Comparison of quetiapine immediate- and extended-release formulations for bipolar depression: A systematic review and network meta-analysis of double-blind, randomized placebo-controlled trials.","This study evaluated the efficacy and safety/tolerability of quetiapine extended-release 300 mg/day (QUEXR300), quetiapine immediate-release 600 mg/day (QUEIR600), and quetiapine immediate-release 300 mg/day (QUEIR300) formulations for treating bipolar depression. A random-effect network meta-analysis of 8-week, double-blind, randomized placebo-controlled trials was used to determine the most optimal agent for intervention. Remission rate was set as the primary outcome. Secondary outcomes were response rate, improvement in the Montgomery-Åsberg Depression Rating Scale score, discontinuation rate, and the incidence of individual adverse events. Seven eligible studies including 3267 participants were included in the meta-analysis. The QUEIR600, QUEIR300, and QUEXR300 groups were superior to the placebo group in every efficacy outcome; however, there were no significant differences in the efficacy outcomes among the treatment groups. All treatment groups exhibited higher incidences of extrapyramidal symptoms, dry mouth, somnolence, constipation, and increase in body weight than the placebo group. The QUEIR600 and QUEIR300 groups had higher incidences of dizziness than the placebo group. The QUEIR600 group had a higher discontinuation rate due to adverse events than the placebo group, and the QUEIR300 group had higher blood HbA1c levels than the placebo group. The QUEIR600 and QUEXR300 groups had higher incidences of ≥7% weight gain than the placebo group. The QUEXR300 group had a higher incidence of fatigue than the QURIR300 and placebo groups. In conclusion, there were no significant differences in the efficacies of QUEIR600, QUEIR300, and QUEXR300 in treating bipolar depression; moreover, tolerance to QUEIR600 might be worse than the other treatments.",2019,"All treatment groups exhibited higher incidences of extrapyramidal symptoms, dry mouth, somnolence, constipation, and increase in body weight than the placebo group.","['bipolar depression', 'Seven eligible studies including 3267 participants were included in the meta-analysis']","['quetiapine extended-release 300\u202fmg/day (QUEXR300), quetiapine immediate-release 600\u202fmg/day (QUEIR600), and quetiapine immediate-release 300\u202fmg/day (QUEIR300) formulations', 'placebo', 'quetiapine immediate- and extended-release formulations']","['efficacy and safety/tolerability', 'discontinuation rate due to adverse events', 'efficacy outcomes', 'extrapyramidal symptoms, dry mouth, somnolence, constipation, and increase in body weight', 'response rate, improvement in the Montgomery-Åsberg Depression Rating Scale score, discontinuation rate, and the incidence of individual adverse events', 'weight gain', 'incidence of fatigue', 'Remission rate', 'efficacies of QUEIR600, QUEIR300, and QUEXR300', 'dizziness', 'blood HbA1c levels']","[{'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0282458', 'cui_str': 'Meta-Analysis'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1135768', 'cui_str': 'Sustained-Release Preparations'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign (finding)'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0005768'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",3267.0,0.292917,"All treatment groups exhibited higher incidences of extrapyramidal symptoms, dry mouth, somnolence, constipation, and increase in body weight than the placebo group.","[{'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Kishi', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan. Electronic address: tarok@fujita-hu.ac.jp.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Ikuta', 'Affiliation': 'Digital Neuroscience Laboratory, Department of Communication Sciences and Disorders, The University of Mississippi, 38677, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sakuma', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Department of Psychiatry, Jikei University School of Medicine, Minato-ku, Tokyo, 105-8461, Japan.'}, {'ForeName': 'Nakao', 'Initials': 'N', 'LastName': 'Iwata', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, 470-1192, Japan.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.05.020']
292,31526206,Dopamine D2 receptor stimulation modulates the balance between ignoring and updating according to baseline working memory ability.,"BACKGROUND


Working memory (WM) deficits in neuropsychiatric disorders have often been attributed to altered dopaminergic signalling. Specifically, D 2  receptor stimulation is thought to affect the ease with which items can be gated into and out of WM. In addition, this effect has been hypothesised to vary according to baseline WM ability, a putative index of dopamine synthesis levels. Moreover, whether D 2  stimulation affects WM vicariously through modulating relatively WM-free cognitive control processes has not been explored.
AIMS


We examined the effect of administering a dopamine agonist on the ability to ignore or update information in WM.
METHOD


A single dose of cabergoline (1 mg) was administered to healthy older adult humans in a within-subject, double-blind, placebo-controlled study. In addition, we obtained measures of baseline WM ability and relatively WM-free cognitive control (overcoming response conflict).
RESULTS


Consistent with predictions, baseline WM ability significantly modulated the effect that drug administration had on the proficiency of ignoring and updating. High-WM individuals were relatively better at ignoring compared to updating after drug administration. Whereas the opposite occurred in low-WM individuals. Although the ability to overcome response conflict was not affected by cabergoline, a negative relationship between the effect the drug had on response conflict performance and ignoring was observed. Thus, both response conflict and ignoring are coupled to dopaminergic stimulation levels.
CONCLUSIONS


Cumulatively, these results provide evidence that dopamine affects subcomponents of cognitive control in a diverse, antagonistic fashion and that the direction of these effects is dependent upon baseline WM.",2019,"Although the ability to overcome response conflict was not affected by cabergoline, a negative relationship between the effect the drug had on response conflict performance and ignoring was observed.",['healthy older adult humans'],"['placebo', 'Dopamine D2 receptor stimulation', 'cabergoline', 'dopamine agonist']",['baseline WM ability and relatively WM-free cognitive control (overcoming response conflict'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0058698', 'cui_str': 'Dopamine D2 Receptor'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0107994', 'cui_str': 'cabergoline'}, {'cui': 'C0178601', 'cui_str': 'Dopaminergic Agonists'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}]",,0.0922998,"Although the ability to overcome response conflict was not affected by cabergoline, a negative relationship between the effect the drug had on response conflict performance and ignoring was observed.","[{'ForeName': 'Sean James', 'Initials': 'SJ', 'LastName': 'Fallon', 'Affiliation': 'Department of Experimental Psychology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Kienast', 'Affiliation': 'Department of Experimental Psychology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kinan', 'Initials': 'K', 'LastName': 'Muhammed', 'Affiliation': 'Department of Experimental Psychology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yuen-Siang', 'Initials': 'YS', 'LastName': 'Ang', 'Affiliation': 'Department of Experimental Psychology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sanjay G', 'Initials': 'SG', 'LastName': 'Manohar', 'Affiliation': 'Department of Experimental Psychology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Masud', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Department of Experimental Psychology, University of Oxford, Oxford, UK.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119872190']
293,31487208,"An open-label randomised comparison of aripiprazole, olanzapine and risperidone for the acute treatment of first-episode schizophrenia: Eight-week outcomes.","PURPOSE


This study aimed to investigate the efficacy and tolerability of aripiprazole, olanzapine and risperidone in first-episode schizophrenia (FES).
METHODS


The eight-week, open, randomised study was conducted in six Chinese medical centres. Altogether, 498 FES subjects were randomised to aripiprazole ( n  = 165), olanzapine ( n  = 168) or risperidone ( n  = 165). Efficacy was measured with the Positive and Negative Syndrome Scale (PANSS), tolerability with the Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) and functioning with the Personal and Social Performance Scale (PSP).
RESULTS


All three antipsychotics significantly improved the baseline to end-point PANSS total and each of the sub-scale scores ( p  < 0.001). Risperidone was superior to olanzapine and aripiprazole regarding PANSS total end-point scores ( p  < 0.05). Cumulative response (PANSS total score reduction ⩾30%) was similar between risperidone, olanzapine and aripiprazole (74.8%, 73.5% and 70.1%;  p  = 0.707), but risperidone was superior to aripiprazole regarding PANSS total score reduction ⩾50% (37.8% vs. 26.6%;  p  < 0.05). Olanzapine was associated with the largest weight gain at week 4 and 8 ( p  < 0.01), weight gain ⩾7% (olanzapine = 49.0% vs. risperidone = 32.5% vs. aripiprazole = 17.0%;  p  < 0.01), more psychic side effects at week 8 ( p  < 0.01 each) and more 'other' side effects at week 4 ( p  < 0.001) and week 8 ( p  < 0.05) but fewer neurological side effects at week 4 ( p  < 0.05) and week 8 ( p  < 0.01). PSP improved more with risperidone than with aripiprazole at week 4 and 8 ( p  < 0.05).
CONCLUSIONS


For FES, risperidone might be a better choice than aripiprazole due to improved efficacy and functional improvement, without inferior tolerability. Aripiprazole is a better choice to avoid relevant short-term weight gain. Olanzapine could be chosen to avoid neurological adverse effects.",2019,Risperidone was superior to olanzapine and aripiprazole regarding PANSS total end-point scores ( p  < 0.05).,"['498 FES subjects', 'six Chinese medical centres', 'first-episode schizophrenia', 'first-episode schizophrenia (FES']","['olanzapine and aripiprazole', 'aripiprazole', 'Olanzapine', 'Risperidone', 'risperidone, olanzapine', 'olanzapine', 'risperidone', 'Aripiprazole', 'aripiprazole, olanzapine and risperidone']","['efficacy and functional improvement, without inferior tolerability', 'largest weight gain', 'Efficacy', 'weight gain ⩾7', 'PANSS total end-point scores', 'psychic side effects', 'PSP', 'neurological side effects', 'efficacy and tolerability', 'Positive and Negative Syndrome Scale (PANSS), tolerability with the Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU) and functioning with the Personal and Social Performance Scale (PSP', 'Cumulative response (PANSS total score reduction ⩾30']","[{'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",498.0,0.0122691,Risperidone was superior to olanzapine and aripiprazole regarding PANSS total end-point scores ( p  < 0.05).,"[{'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Centre for Mental Disorders (Peking University Sixth Hospital), Beijing, PR China.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Centre for Mental Disorders (Peking University Sixth Hospital), Beijing, PR China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Centre for Mental Disorders (Peking University Sixth Hospital), Beijing, PR China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Centre for Mental Disorders (Peking University Sixth Hospital), Beijing, PR China.'}, {'ForeName': 'Shangli', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': 'Mental Health Institute, Second Xiangya Hospital, Central South University, Changsha, PR China.'}, {'ForeName': 'Fude', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Beijing Hui-Long-Guan Hospital, Beijing, PR China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'Tongji Hospital of Tongji University, Shanghai, PR China.'}, {'ForeName': 'Chuanyue', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Beijing Anding Hospital, Capital Medical University, Beijing, PR China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'West China Hospital, Sichuan University, Chengdu, PR China.'}, {'ForeName': 'Jingping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Mental Health Institute, Second Xiangya Hospital, Central South University, Changsha, PR China.'}, {'ForeName': 'Yutao', 'Initials': 'Y', 'LastName': 'Xiang', 'Affiliation': 'Unit of Psychiatry, Faculty of Health Science, University of Macau, Macao SAR, PR China.'}, {'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': 'The Zucker Hillside Hospital, Psychiatry Research, Northwell Health, Glen Oaks, NY, USA.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Centre for Mental Disorders (Peking University Sixth Hospital), Beijing, PR China.'}]","Journal of psychopharmacology (Oxford, England)",['10.1177/0269881119872193']
294,31134827,Protective Effect of Hyperbaric Oxygen Therapy on Cognitive Function in Patients with Vascular Dementia.,"Recent studies have shown that hyperbaric oxygen (HBO) has a therapeutic effect on vascular dementia (VD); however, the exact mechanism remains unclear. This article aims to reveal the protective effects and underlying mechanisms of HBO on VD. A total of 158 patients with VD were prospectively included in the study and were randomly divided into control group and HBO group. The control group was given conventional treatment and the HBO group was treated with HBO in addition to conventional treatment. The following HBO protocol was practiced: 5 days per week, 60 min each, 100% oxygen at 2 standard atmospheric pressures for 12 weeks. The Mini-Mental State Examination (MMSE) scores and serum Humanin levels were detected before and after treatments in both groups. The baseline characteristics were not different dramatically between groups ( p  > 0.05). There was no significant difference in MMSE scores and serum Humanin levels between the two groups before treatment ( p  > 0.05). After treatment, compared with the control group, the MMSE scores and serum Humanin levels in the HBO group were significantly increased ( p  < 0.05). Spearman correlation analysis showed that the serum Humanin levels were positively correlated with MMSE scores ( r  = 0.409,  p  < 0.05) and this correlation was independent of baseline characteristics (β = 0.312,  p  < 0.05). HBO therapy can improve cognitive function in patients with VD, and its mechanism may be related to elevated serum Humanin levels.",2019,There was no significant difference in MMSE scores and serum Humanin levels between the two groups before treatment ( p > 0.05).,"['Patients with Vascular Dementia', '158 patients with VD', 'patients with VD']","['hyperbaric oxygen (HBO', 'HBO', 'Hyperbaric Oxygen Therapy', 'HBO therapy']","['cognitive function', 'Cognitive Function', 'serum Humanin levels', 'MMSE scores', 'MMSE scores and serum Humanin levels', 'Mini-Mental State Examination (MMSE) scores and serum Humanin levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011269', 'cui_str': 'Dementia, Vascular'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric Oxygen Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0966511', 'cui_str': 'humanin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}]",158.0,0.0169,There was no significant difference in MMSE scores and serum Humanin levels between the two groups before treatment ( p > 0.05).,"[{'ForeName': 'Yuzhen', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""1 Department of Neurology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': '3 Department of Central Laboratory, Taian City Central Hospital, Shandong First Medical University & Shandong Academy of Medical Sciences, Taian, Shandong Province, China.'}, {'ForeName': 'Zhongsen', 'Initials': 'Z', 'LastName': 'Qu', 'Affiliation': ""1 Department of Neurology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""1 Department of Neurology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Xinping', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': '2 Department of Neurology, Taian City Central Hospital, Shandong First Medical University & Shandong Academy of Medical Sciences, Taian, Shandong Province, China.'}, {'ForeName': 'Yuwu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""1 Department of Neurology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}]",Cell transplantation,['10.1177/0963689719853540']
295,32278783,Re-evaluation of the Uplift Clinical Trial Using Age-Appropriate Spirometric Criteria.,"BACKGROUND


The clinical trial of tiotropium in COPD, UPLIFT, enrolled adults with a mean age of 65 years and moderate-to-severe airflow obstruction, based on criteria from the Global Initiative for Chronic Obstructive Lung Disease (GOLD). For the UPLIFT cohort, however, GOLD-based criteria are not age-appropriate.
RESEARCH QUESTION


Will the use of more age-appropriate criteria for airflow obstruction from the Global Lung Function Initiative (GLI) modify the spirometric classification of the UPLIFT cohort and, in turn, the mortality effect of tiotropium in COPD?
STUDY DESIGN AND METHODS


Baseline spirometric classifications were first cross-tabulated by GLI- and GOLD-based criteria. Next, in GLI- and GOLD-based airflow obstruction, modified intention-to-treat analyses evaluated differences in time to death over 4 years, comparing tiotropium vs placebo. Because treatment response may differ by COPD severity, the mortality effect also was evaluated within stratum defined by GLI- and GOLD-based moderate and severe airflow obstruction.
RESULTS


Of 5,898 participants with GOLD-based airflow-obstruction, staged as moderate in 2,739 (46.4%) and severe in 3,156 (53.5%), GLI-based criteria established airflow obstruction in 5,750 (97.5%), staged as moderate in 795 (13.5%) and severe in 4,947 (83.9%). Relative to placebo, tiotropium yielded statistically nonsignificant adjusted hazard ratios (adjHRs) (95% CI) for death of 0.91 (0.80-1.04) and 0.91 (0.79-1.03) in GLI- and GOLD-based airflow obstruction, respectively. However, statistically significant effect modification was observed, but only in GLI-based moderate and severe airflow-obstruction, with tiotropium yielding adjHRs for death of 0.53 (0.34-0.81) and 0.99 (0.86-1.13), respectively. The P value for interaction was .007.
INTERPRETATION


Mortality reduction by tiotropium was only statistically significant in GLI-based moderate airflow-obstruction, a group that was underrepresented in UPLIFT because of severity misclassification by the original GOLD-based enrollment criteria.",2020,"Relative to placebo, tiotropium yielded statistically non-significant adjusted hazard ratios (adjHRs) (95% confidence interval) for death of 0.91 (0.80, 1.04) and 0.91 (0.79, 1.03) in GLI- and GOLD-based airflow-obstruction, respectively.","['and Methods', 'chronic obstructive pulmonary disease (COPD), i.e. UPLIFT, enrolled adults with a mean age of 65 years and moderate-to-severe airflow-obstruction, based on criteria from the Global Initiative for Chronic Obstructive Lung Disease (GOLD', '5898 participants with GOLD-based']","['placebo, tiotropium', 'tiotropium', 'tiotropium vs. placebo']","['GLI-based moderate and severe airflow-obstruction', 'GLI-based criteria established airflow-obstruction', 'hazard ratios (adjHRs', 'mortality effect', 'Mortality reduction', 'airflow-obstruction']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",5898.0,0.179374,"Relative to placebo, tiotropium yielded statistically non-significant adjusted hazard ratios (adjHRs) (95% confidence interval) for death of 0.91 (0.80, 1.04) and 0.91 (0.79, 1.03) in GLI- and GOLD-based airflow-obstruction, respectively.","[{'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Vaz Fragoso', 'Affiliation': 'Veterans Affairs (VA) Connecticut Healthcare System, West Haven; Yale University School of Medicine, Department of Internal Medicine, New Haven, CT. Electronic address: carlos.fragoso@yale.edu.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Leo-Summers', 'Affiliation': 'Yale University School of Medicine, Department of Internal Medicine, New Haven, CT.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Yale University School of Medicine, Department of Internal Medicine, New Haven, CT.'}, {'ForeName': 'Gail J', 'Initials': 'GJ', 'LastName': 'McAvay', 'Affiliation': 'Yale University School of Medicine, Department of Internal Medicine, New Haven, CT.'}]",Chest,['10.1016/j.chest.2020.02.070']
296,32276980,A Mediterranean Diet Intervention Reduces the Levels of Salivary Periodontopathogenic Bacteria in Overweight and Obese Subjects.,"The human oral cavity is a complex ecosystem, and the alterations in salivary microbial communities are associated with both oral and nonoral diseases. The Mediterranean diet (MD) is a healthy dietary pattern useful for both prevention and treatment of several diseases. To further explore the effects of the MD on human health, in this study, we investigated the changes in the salivary microbial communities in overweight/obese subjects after an individually tailored MD-based nutritional intervention. Healthy overweight and obese subjects were randomized between two intervention groups. The MD group (Med-D group) increased their MD adherence during 8 weeks of intervention while the control diet (control-D) group did not change their dietary habits. The salivary microbiota was assessed at baseline and after 4 and 8 weeks of intervention. Despite no observed changes in the overall salivary microbiota composition, we found a significant decrease in the relative abundances of species-level operational taxonomic units annotated as  Porphyromonas gingivalis ,  Prevotella intermedia , and  Treponema denticola  in the Med-D group compared to that in the control-D group after 8 weeks of intervention, which are known to be associated with periodontal disease. Such variations were significantly linked to dietary variables such as MD adherence rates and intakes of animal versus vegetable proteins. In addition, increased levels of  Streptococcus cristatus  were observed in the Med-D group, which has been reported as an antagonistic taxon inhibiting  P. gingivalis  gene expression. Our findings suggest that an MD-based nutritional intervention may be implicated in reducing periodontal bacteria, and an MD may be a dietary strategy supportive of oral homeostasis. IMPORTANCE  Changes in dietary behavior with increased adherence to a Mediterranean diet can determine a reduction of periodontopathogenic bacterial abundances in the saliva of overweight subjects with cardiometabolic risk due to an unhealthy lifestyle, without any change in individual energy intake, nutrient intake, and physical activity.",2020,The Med-D group increased the MD adherence during 8 weeks of intervention while the Control-D group did not change the dietary habits.,"['overweight and obese subjects', 'Healthy overweight and obese subjects', 'overweight/obese subjects after an individually tailored MD-based nutritional intervention']","['Mediterranean diet intervention', 'Mediterranean diet (MD', 'MD']","['salivary microbiota', 'overall salivary microbiota composition', 'salivary periodontopathogenic bacteria', 'levels of  Streptococcus cristatus', 'MD adherence']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0318141', 'cui_str': 'Streptococcus cristatus'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0139182,The Med-D group increased the MD adherence during 8 weeks of intervention while the Control-D group did not change the dietary habits.,"[{'ForeName': 'Manolo', 'Initials': 'M', 'LastName': 'Laiola', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'De Filippis', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vitaglione', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Ercolini', 'Affiliation': 'Department of Agricultural Sciences, University of Naples Federico II, Portici, Italy ercolini@unina.it.'}]",Applied and environmental microbiology,['10.1128/AEM.00777-20']
297,32277514,Biosafety of Sonography: Survey of Current Knowledge and Practice Patterns in Obstetrics Providers.,"OBJECTIVES


Sonography is routinely performed in obstetrics. For safety purposes, intensity-output displays are included in all ultrasound machines. There are few studies performed on provider understanding of ultrasound safety. We sought to assess obstetrics providers' level of knowledge on ultrasound biosafety before and after educational intervention.
METHODS


This is a cross-sectional study using survey research to examine the knowledge of obstetrics providers performing sonography. The study included faculty, fellows, and residents in obstetrics and gynecology and family medicine, and certified nurse midwives. After completion of the initial survey, subjects were randomly assigned to 1 of 3 educational interventions. The interventions included reading an article, watching an educational video, or viewing a PowerPoint presentation. After completing the intervention, subjects answered a post-intervention survey.
RESULTS


A total of 138 responses were received from the initial survey. Fifty-eight individuals completed the intervention and post-intervention survey. Across all levels of training and practice, before intervention, 70% of providers indicated that they did not recognize output display standard functions. Of the 58 individuals who completed the intervention and both surveys, all knowledge-based questions resulted in statistically significant improvements in scores.
CONCLUSIONS


Sonography is increasingly used in the obstetric setting, and it is essential that providers and trainees understand the risks of the procedures they perform. Our data suggests a need for improved education on ultrasound safety. Improvement in scores on the post-intervention knowledge assessment suggests that the educational interventions used may be beneficial in enhancing provider understanding of obstetric ultrasound safety.",2020,"Of the 58 individuals who completed the intervention and both surveys, all knowledge-based questions resulted in statistically significant improvements in scores.
","['Fifty-eight individuals completed the intervention and post-intervention survey', 'faculty, fellows, and residents in obstetrics and gynecology and family medicine, and certified nurse midwives', 'A total of 138 responses were received from the initial survey', 'Obstetrics Providers']","['reading an article, watching an educational video, or viewing a PowerPoint presentation']",['scores'],"[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0028655', 'cui_str': 'Nurse-Midwife'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}]",138.0,0.0247863,"Of the 58 individuals who completed the intervention and both surveys, all knowledge-based questions resulted in statistically significant improvements in scores.
","[{'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Wasickanin', 'Affiliation': 'Department of Obstetrics and Gynecology, Madigan Army Medical Center, Tacoma, Washington, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lentscher', 'Affiliation': 'Department of Obstetrics and Gynecology, Madigan Army Medical Center, Tacoma, Washington, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Foglia', 'Affiliation': 'Department of Obstetrics and Gynecology, Madigan Army Medical Center, Tacoma, Washington, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Colburn', 'Affiliation': 'Department of Obstetrics and Gynecology, Madigan Army Medical Center, Tacoma, Washington, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Estrada', 'Affiliation': 'Department of Obstetrics and Gynecology, Madigan Army Medical Center, Tacoma, Washington, USA.'}]",Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine,['10.1002/jum.15273']
298,32086551,Neural responses in the pain matrix when observing pain of others are unaffected by testosterone administration in women.,"There is evidence of testosterone having deteriorating effects on cognitive and affective empathic behaviour in men and women under varying conditions. However, whether testosterone influences empathy for pain has not yet been investigated. Therefore, we tested neural responses to witnessing others in pain in a within-subject placebo-controlled testosterone administration study in healthy young women. Using functional magnetic resonance imaging, we provide affirming evidence that an empathy-inducing paradigm causes changes in the activity throughout the pain circuitry, including the bilateral insula and anterior cingulate cortex. Administration of testosterone, however, did not influence these activation patterns in the pain matrix. Testosterone has thus downregulating effects on aspects of empathic behaviour, but based on these data does not seem to influence neural responses during empathy for others' pain. This finding gives more insight into the role of testosterone in human empathy.",2020,There is evidence of testosterone having deteriorating effects on cognitive and affective empathic behaviour in men and women under varying conditions.,"['men and women under varying conditions', 'healthy young women']","['placebo-controlled testosterone', 'Testosterone', 'testosterone']",['cognitive and affective empathic behaviour'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}]",[],,0.324285,There is evidence of testosterone having deteriorating effects on cognitive and affective empathic behaviour in men and women under varying conditions.,"[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Heany', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Terburg', 'Affiliation': 'Department of Experimental Psychology, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'van Honk', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Bos', 'Affiliation': 'Institute of Education and Child Studies, Leiden University, Leiden, The Netherlands. p.a.bos@fsw.leidenuniv.nl.'}]",Experimental brain research,['10.1007/s00221-020-05749-3']
299,32275060,"Implementation of a Transitional Care Model for Stroke: Perspectives From Frontline Clinicians, Administrators, and COMPASS-TC Implementation Staff.","BACKGROUND AND OBJECTIVES


Stroke is a chronic, complex condition that disproportionally affects older adults. Health systems are evaluating innovative transitional care (TC) models to improve outcomes in these patients. The Comprehensive Post-Acute Stroke Services (COMPASS) Study, a large cluster-randomized pragmatic trial, tested a TC model for patients with stroke or transient ischemic attack discharged home from the hospital. The implementation of COMPASS-TC in complex real-world settings was evaluated to identify successes and challenges with integration into the clinical workflow.
RESEARCH DESIGN AND METHODS


We conducted a concurrent process evaluation of COMPASS-TC implementation during the first year of the trial. Qualitative data were collected from 4 sources across 19 intervention hospitals. We analyzed transcripts from 43 conference calls with hospital clinicians, individual and group interviews with leaders and clinicians from 9 hospitals, and 2 interviews with the COMPASS-TC Director of Implementation using iterative thematic analysis. Themes were compared to the domains of the RE-AIM framework.
RESULTS


Organizational, individual, and community factors related to Reach, Adoption, and Implementation were identified. Organizational readiness was an additional key factor to successful implementation, in that hospitals that were not ""organizationally ready"" had more difficulty addressing implementation challenges.
DISCUSSION AND IMPLICATIONS


Multifaceted TC models are challenging to implement. Facilitators of implementation were organizational commitment and capacity, prioritizing implementation of innovative delivery models to provide comprehensive care, being able to address challenges quickly, implementing systems for tracking patients throughout the intervention, providing clinicians with autonomy and support to address challenges, and adequately resourcing the intervention.
CLINICAL TRIAL REGISTRATION


NCT02588664.",2020,"The implementation of COMPASS-TC in complex real-world settings was evaluated to identify successes and challenges with integration into the clinical workflow.
","['43 conference calls with hospital clinicians, individual and group interviews with leaders and clinicians from 9 hospitals, and 2 interviews with the COMPASS-TC Director of Implementation using iterative thematic analysis', 'older adults', 'patients with stroke or transient ischemic attack discharged home from the hospital']","['COMPASS-TC implementation', 'TC model']",[],"[{'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018260', 'cui_str': 'Group Interviews'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",[],,0.0397485,"The implementation of COMPASS-TC in complex real-world settings was evaluated to identify successes and challenges with integration into the clinical workflow.
","[{'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Lutz', 'Affiliation': 'School of Nursing, University of North Carolina at Wilmington.'}, {'ForeName': 'Alexandria E', 'Initials': 'AE', 'LastName': 'Reimold', 'Affiliation': 'School of Nursing, University of North Carolina at Wilmington.'}, {'ForeName': 'Sylvia W', 'Initials': 'SW', 'LastName': 'Coleman', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Guzik', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Laurie P', 'Initials': 'LP', 'LastName': 'Russell', 'Affiliation': 'Division of Public Health Sciences, Wake Forest University Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Meghan D', 'Initials': 'MD', 'LastName': 'Radman', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Johnson', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Pamela W', 'Initials': 'PW', 'LastName': 'Duncan', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Cheryl D', 'Initials': 'CD', 'LastName': 'Bushnell', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Wayne D', 'Initials': 'WD', 'LastName': 'Rosamond', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Sabina B', 'Initials': 'SB', 'LastName': 'Gesell', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]",The Gerontologist,['10.1093/geront/gnaa029']
300,32275315,Effective Peer Leader Attributes for the Promotion of Walking in Older Adults.,"BACKGROUND AND OBJECTIVES


Peer-led interventions are promising for the promotion of physical activity behavior in older adults. However, little is known about the attributes of effective older peer leaders in such intervention programs. The objective was to determine what older adults perceive to be effective peer leader attributes.
RESEARCH DESIGN AND METHODS


A mixed-methods concurrent triangulation design was used. Participants, aged 60 years and older, were recruited from retirement villages and existing walking groups in Western Australia. They were predominantly white, Australian-born, female, healthy retirees. The sample consisted of four groups of older adults: those who had taken part in past peer-led walking programs (experienced walkers; n = 18), those interested in joining as walkers in a peer-led walking intervention (inexperienced walkers; n = 43), those interested to take on a peer leader role (inexperienced peer leaders; n = 25), and those who had already served as peer leaders (experienced peer leaders; n = 15). Questionnaires measured perceived effective leadership attributes, and physical activity was measured using ActivPAL devices (N = 101; Mage [SD] = 75.36 [7.59]). Semistructured interviews were conducted with the majority of participants (N = 68; Mage [SD] = 74.68 [7.78]).
RESULTS


Overall, participants described an effective peer leader as optimistic, compassionate, and friendly, but differences in perceptions were apparent between the groups.
DISCUSSION AND IMPLICATIONS


Our findings advance knowledge about important characteristics of an effective older peer leader, which can inform peer leader training, recruitment of peer leaders, and future scale development.",2020,"Overall, participants described an effective peer leader as optimistic, compassionate, and friendly, but differences in perceptions were apparent between the groups.
","['older adults', 'older adults: those who had taken part in past peer-led walking programs (experienced walkers; n = 18), those interested in joining as walkers in a peer-led walking intervention (inexperienced walkers; n = 43), those interested to take on a peer leader role (inexperienced peer leaders; n = 25), and those who had already served as peer leaders (experienced peer leaders; n = 15', 'Participants, aged 60 years and older, were recruited from retirement villages and existing walking groups in Western Australia', 'They were predominantly white, Australian-born, female, healthy retirees', 'Older Adults']",[],"['effective leadership attributes, and physical activity']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043016', 'cui_str': 'Walker'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0035345', 'cui_str': 'Retired'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023181', 'cui_str': 'Leadership'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0261899,"Overall, participants described an effective peer leader as optimistic, compassionate, and friendly, but differences in perceptions were apparent between the groups.
","[{'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Kritz', 'Affiliation': 'Health Psychology and Behavioral Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Thøgersen-Ntoumani', 'Affiliation': 'Health Psychology and Behavioral Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mullan', 'Affiliation': 'Health Psychology and Behavioral Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'McVeigh', 'Affiliation': 'Physical Activity and Wellbeing Research Group, School of Psychology, Curtin University, Perth, Western Australia.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Ntoumanis', 'Affiliation': 'Health Psychology and Behavioral Medicine Research Group, School of Psychology, Curtin University, Perth, Western Australia.'}]",The Gerontologist,['10.1093/geront/gnaa014']
301,32277872,"Heat-inactivated Bifidobacterium bifidum MIMBb75 (SYN-HI-001) in the treatment of irritable bowel syndrome: a multicentre, randomised, double-blind, placebo-controlled clinical trial.","BACKGROUND


Bifidobacterium bifidum MIMBb75 is one of a few probiotic strains that have been shown to be effective in the treatment of irritable bowel syndrome (IBS) and its symptoms. Non-viable strains might have advantages over viable bacteria for product stability and standardisation, as well as for tolerability because safety concerns have been raised for specific patient groups who are susceptible to infection. We aimed to assess the efficacy of non-viable, heat-inactivated (HI) B bifidum MIMBb75 (SYN-HI-001) in the treatment of IBS and its symptoms.
METHODS


We did a double-blind, placebo-controlled trial in which patients with IBS were recruited from 20 study sites in Germany and randomly assigned to receive either two placebo capsules or two capsules with a combined total of 1 × 10 9  non-viable B bifidum HI-MIMBb75 cells to be taken orally once a day for 8 weeks. Eligible patients were diagnosed with IBS according to Rome III criteria and had abdominal pain (≥4 on an 11-point numerical rating scale) on at least 2 days during a 2-week run-in phase. Patients with chronic inflammatory bowel diseases, systemic diseases, cancer, autoimmune diseases, with an intake of antipsychotic medications 3 months before study start, or with an intake of systemic corticosteroids within 1 month before study start were excluded. Randomisation was in a 1:1 ratio according to a computer-generated blocked list. Patients, investigators, clinical monitors, project managers, and statisticians were masked to the randomisation. The primary composite endpoint was the combination of at least 30% improvement of abdominal pain and adequate relief of overall IBS symptoms being fulfilled in at least 4 of 8 weeks during treatment. Analysis of the primary endpoint included all randomly assigned patients receiving at least one dose of study medication and who had no severe protocol violation. Safety analysis included all patients who had taken at least one dose of the study medication and was based on frequency and severity of adverse events, laboratory evaluation, and global assessment of tolerability. This trial is registered with the ISRCTN registry, ISRCTN14066467, and is completed: the results shown here represent the final analysis.
FINDINGS


Patients were screened between April 15, 2016, and Feb 3, 2017, and 443 patients were allocated to the placebo group (n=222) or the B bifidum HI-MIMBb75 group (n=221). The composite primary endpoint was reached by 74 (34%) of 221 patients in the B bifidum HI-MIMBb75 group compared with 43 (19%) of 222 in the placebo group (risk ratio 1·7, 95% CI 1·3-2·4; p=0·0007). No serious adverse events occurred in the B bifidum HI-MIMBb75 group; seven adverse events suspected to be related to the study product were reported in the B bifidum HI-MIMBb75 group as were eight in the placebo group. No deaths were reported in this study. The most common reported adverse event with a suspected relationship to the study product was abdominal pain, which was reported in two (<1%) patients in the B bifidum HI-MIMBb75 group and one (<1%) in the placebo group. Tolerability was rated as very good or good by 200 (91%) patients in the B bifidum HI-MIMBb75 group compared with 191 (86%) in the placebo group.
INTERPRETATION


This study shows that B bifidum HI-MIMBb75 substantially alleviates IBS and its symptoms in a real-life setting. These results indicate that specific beneficial bacterial effects are mediated independently of cell viability.
FUNDING


Synformulas.",2020,No serious adverse events occurred in the B bifidum HI-MIMBb75 group; seven adverse events suspected to be related to the study product were reported in the B bifidum HI-MIMBb75 group as were eight in the placebo group.,"['Patients were screened between April 15, 2016, and Feb 3, 2017, and 443 patients', 'Patients with chronic inflammatory bowel diseases, systemic diseases, cancer, autoimmune diseases, with an intake of antipsychotic medications 3 months before study start, or with an intake of systemic corticosteroids within 1 month before study start were excluded', 'irritable bowel syndrome', 'patients with IBS were recruited from 20 study sites in Germany', 'patients who had taken at least one dose of the study medication and was based on', 'Eligible patients were diagnosed with IBS according to Rome III criteria and had abdominal pain (≥4 on an 11-point numerical rating scale) on at least 2 days during a 2-week run-in phase']","['Heat-inactivated Bifidobacterium bifidum MIMBb75 (SYN-HI-001', 'placebo capsules or two capsules with a combined total of 1\u2008×\u200810 9  non-viable B bifidum HI-MIMBb75 cells', 'placebo', 'B bifidum HI-MIMBb75', 'non-viable, heat-inactivated (HI) B bifidum MIMBb75 (SYN-HI-001']","['combination of at least 30% improvement of abdominal pain and adequate relief of overall IBS symptoms', 'Tolerability', 'frequency and severity of adverse events, laboratory evaluation, and global assessment of tolerability', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0442893', 'cui_str': 'Systemic disease'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.363173,No serious adverse events occurred in the B bifidum HI-MIMBb75 group; seven adverse events suspected to be related to the study product were reported in the B bifidum HI-MIMBb75 group as were eight in the placebo group.,"[{'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Andresen', 'Affiliation': 'Department of Internal Medicine, Israelitic Hospital, University of Hamburg Teaching Hospital, Hamburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Gschossmann', 'Affiliation': 'Department of Internal Medicine, Hospital Forchheim, Forchheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Layer', 'Affiliation': 'Department of Internal Medicine, Israelitic Hospital, University of Hamburg Teaching Hospital, Hamburg, Germany. Electronic address: p.layer@ik-h.de.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30056-X']
302,32273054,Trends in Treatment for Patients Hospitalized with Heart Failure with Preserved Ejection Fraction Before and After Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT).,"The TOPCAT trial investigated spironolactone vs placebo in patients with heart failure with preserved ejection fraction (HFpEF). Although the primary endpoint was not statistically significant, treatment with spironolactone did reduce heart failure hospitalizations compared with placebo. TOPCAT's impact on prescribing patterns in the United States is not well-characterized. We performed a retrospective analysis of discharge prescribing data in the Get With The Guidelines-Heart Failure Registry among patients with left ventricular ejection fraction ≥50% discharged between January 2009 and December 2016 to assess prescribing trends upon dissemination of TOPCAT results. Of 142,201 patients included in the study, 18,581 (13.1%) were prescribed mineralocorticoid receptor antagonists (MRAs) at discharge. Compared with those not prescribed MRAs, patients discharged on MRAs were generally younger (75 vs 78 years), and report white race (76.7% vs 72.0%), more likely to have had prior heart failure hospitalizations (75.5% vs 65.7%), lower brain natriuretic peptide levels (492 vs 545 pg/mL), but similar serum creatinine levels (1.2 vs 1.2 mg/dL) upon admission. MRA prescribing modestly increased over time (p <0.0001), without significant change in the overall trend of prescribing rate for MRAs after TOPCAT results were presented (p =0.17). In conclusion, our findings suggest that for patients with HFpEF, the use of MRAs at hospital discharge is low, with only modest increases over time and no discernible change in the rate of MRA use after the TOPCAT results were released. There remains an important need for more clinical trials to better establish the efficacy and safety of MRAs for the treatment of HFpEF.",2020,"MRA prescribing modestly increased over time (p <0.0001), without significant change in the overall trend of prescribing rate for MRAs after TOPCAT results were presented (p =0.17).","['Patients Hospitalized with Heart Failure with Preserved Ejection Fraction Before and After Treatment of Preserved Cardiac Function Heart Failure With an', 'patients with heart failure with preserved ejection fraction (HFpEF', 'patients with left ventricular ejection fraction', 'Of 142,201 patients included in the study, 18,581 (13.1%) were prescribed mineralocorticoid receptor antagonists (MRAs) at discharge']","['Aldosterone Antagonist (TOPCAT', 'placebo', 'spironolactone', 'spironolactone vs placebo']","['prescribing rate for MRAs', 'serum creatinine levels', 'heart failure hospitalizations', 'lower brain natriuretic peptide levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}]","[{'cui': 'C0002007', 'cui_str': 'Aldosterone receptor antagonist-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement'}]",142201.0,0.103052,"MRA prescribing modestly increased over time (p <0.0001), without significant change in the overall trend of prescribing rate for MRAs after TOPCAT results were presented (p =0.17).","[{'ForeName': 'Marat', 'Initials': 'M', 'LastName': 'Fudim', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Kelly', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Brophy', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Bradley G', 'Initials': 'BG', 'LastName': 'Hammill', 'Affiliation': 'Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Clyde', 'Initials': 'C', 'LastName': 'Yancy', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'Ahmanson-UCLA Cardiomyopathy Center, University of California Los Angeles Medical Center, Los Angeles, California.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina; Duke Clinical Research Institute and Duke University Medical Center, Durham, North Carolina. Electronic address: adrian.hernandez@duke.edu.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.02.038']
303,32168216,Cephalic Elevation Device for Second-Stage Cesarean Delivery: A Randomized Controlled Trial.,"OBJECTIVE


A cephalic elevation device is an inflatable device that elevates the fetal head. We sought to evaluate whether such a device reduces time to delivery after hysterotomy and lowers morbidity in cesarean deliveries during the second stage of labor.
METHODS


We conducted a double-blind randomized controlled trial among nulliparous, term women aged 18-50 years with vertex singleton pregnancies. Women were eligible if they were to undergo cesarean delivery in the second stage of labor. All participating women had the cephalic elevation device inserted by the delivering provider and were randomly allocated to inflation or noninflation of the device. Inflation was performed in a blinded fashion. The primary outcome was time from hysterotomy to delivery. A sample size of 30 per group (N=60 participants) was planned to detect a 50% decrease in time to delivery after hysterotomy with cephalic elevation device inflation.
RESULTS


From January 2018 through July 2019, 60 women who underwent cesarean delivery in the second stage were randomized. Analysis was by intention to treat. Women in the inflation group were older (33 vs 30.5 years), but the groups were otherwise similar. In both groups, most women had a low-transverse hysterotomy (93%). The median time from hysterotomy to delivery was significantly shorter in the inflation group (31 vs 54 seconds; P<.01). There was no significant difference in neonatal outcomes.
CONCLUSION


Use of the cephalic elevation device during second-stage cesarean delivery led to a 23-second reduction time from hysterotomy to delivery.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT03342508.
FUNDING SOURCE


The cephalic elevation devices used in this study were donated by Safe Obstetrics Systems.",2020,The median time from hysterotomy to delivery was significantly shorter in the inflation group (31 vs 54 seconds; P<.01).,"['cesarean deliveries during the second stage of labor', 'All participating women had the cephalic elevation device inserted by the delivering provider', 'Women were eligible if they were to undergo cesarean delivery in the second stage of labor', 'nulliparous, term women aged 18-50 years with vertex singleton pregnancies', 'From January 2018 through July 2019, 60 women who underwent cesarean delivery in the second stage were randomized']",['Cephalic Elevation Device'],"['time from hysterotomy to delivery', 'median time from hysterotomy to delivery', 'neonatal outcomes']","[{'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0022872', 'cui_str': 'Labor Stage, Second'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205096', 'cui_str': 'Cephalic (qualifier value)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0230003', 'cui_str': 'Vertex structure'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}]","[{'cui': 'C0205096', 'cui_str': 'Cephalic (qualifier value)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0020711', 'cui_str': 'Hysterotomy'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}]",60.0,0.467182,The median time from hysterotomy to delivery was significantly shorter in the inflation group (31 vs 54 seconds; P<.01).,"[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Lassey', 'Affiliation': ""Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Little', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Saadeh', 'Affiliation': ''}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Patton', 'Affiliation': ''}, {'ForeName': 'Michaela K', 'Initials': 'MK', 'LastName': 'Farber', 'Affiliation': ''}, {'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Bateman', 'Affiliation': ''}, {'ForeName': 'Julian N', 'Initials': 'JN', 'LastName': 'Robinson', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003746']
304,32278771,Randomized Trial of Monthly Versus As-Needed Intravitreal Ranibizumab for Radiation Retinopathy-Related Macular Edema: 1-Year Outcomes.,"PURPOSE


To assess efficacy of intravitreal ranibizumab injections and targeted panretinal photocoagulation (TRP) for radiation retinopathy-related macular edema.
DESIGN


Phase IIb, prospective, randomized clinical trial.
METHODS


Setting: Multicenter.
SUBJECTS


Forty eyes in 40 treatment-naïve patients with radiation-induced macular edema and a resulting decrease in visual acuity ranging between 20/25 and 20/400 (Snellen equivalent).
INTERVENTION


Patients either received intravitreal 0.5 mg ranibizumab monthly, monthly ranibizumab with TRP, or 3 monthly ranibizumab (loading doses) followed by as-needed (PRN) injections and TRP. After week 52, all subjects entered a treat-and-extend protocol for ranibizumab. MainOutcomeMeasures: Mean Early Treatment Diabetic Maculopathy Study (ETDRS) BCVA change from baseline.
RESULTS


Mean patient age was 57 years (range, 22-80 years), ETDRS BCVA was 56.7 letters (20/74 Snellen equivalent), and central macular thickness (CMT) was 423 μm (range, 183-826 μm). Thirty-seven patients completed the month 12 visit (92.5%), at which time the change in mean BCVA was +4.0 letters, -1.9 letters, and +0.9 letters in the monthly, monthly plus laser, and PRN plus laser cohorts, respectively. There was a significant difference in mean BCVA at 1 year among all 3 cohorts (P < .001), as well as between cohorts in pairwise comparisons, with the most significant gains in the monthly group. A total of 82.5% of the patients retained visual acuity of 20/200 or better, and 20.0% improved 10 or more ETDRS letters.
CONCLUSIONS


Ranibizumab may improve vision and anatomy in patients with radiation retinopathy-related macular edema and prevent vision loss through 48 weeks of therapy. Monthly injections were more effective than as-needed approach, and the addition of TRP yielded no therapeutic benefits.",2020,"There was a significant difference in mean BCVA at 1 year among all three cohorts (p<0.001), as well as between cohorts in pairwise comparisons, with the most significant gains in the monthly group.","['Mean patient age was 57 years (range, 22-80), ETDRS BCVA was 56.7 letters (20/74 Snellen-equivalent), and central macular thickness (CMT) was 423 um (range, 183-826', 'multi-center PATIENTS: 40 eyes in 40 treatment-naïve patients with radiation-induced macular edema and a resulting decrease in visual acuity ranging between 20/25 and 20/400 (Snellen-equivalent', 'patients with radiation retinopathy-related macular edema', 'Radiation Retinopathy-Related Macular Edema']","['intravitreal ranibizumab injections and targeted pan-retinal photocoagulation (TRP', 'intravitreal 0.5mg ranibizumab monthly, monthly ranibizumab with TRP, or 3 monthly ranibizumab (loading doses) followed by as-needed (PRN) injections and TRP', 'Ranibizumab', 'ranibizumab', 'Intravitreal Ranibizumab']","['mean BCVA', 'Mean ETDRS', 'visual acuity', 'vision and anatomy', 'BCVA change']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0183370', 'cui_str': 'Snellen chart'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1690939', 'cui_str': '20/25'}, {'cui': 'C0442765', 'cui_str': '20/400'}, {'cui': 'C0339483', 'cui_str': 'Radiation retinopathy'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C0030266', 'cui_str': 'Panama'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0023694', 'cui_str': 'Photocoagulation'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.124777,"There was a significant difference in mean BCVA at 1 year among all three cohorts (p<0.001), as well as between cohorts in pairwise comparisons, with the most significant gains in the monthly group.","[{'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Schefler', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas, USA; Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas, USA. Electronic address: acsmd@houstonretina.com.'}, {'ForeName': 'Dwain', 'Initials': 'D', 'LastName': 'Fuller', 'Affiliation': 'Texas Retina Associates, Dallas, Texas, USA.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Anand', 'Affiliation': 'Texas Retina Associates, Dallas, Texas, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Fuller', 'Affiliation': 'Texas Retina Associates, Dallas, Texas, USA.'}, {'ForeName': 'Chelsey', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Munoz', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas, USA.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Kim', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas, USA; McGovern Medical School, University of Texas Health Science Center, Houston, Texas, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2020.03.045']
305,32278779,"Association of Guideline-Recommended COPD Inhaler Regimens With Mortality, Respiratory Exacerbations, and Quality of Life: A Secondary Analysis of the Long-Term Oxygen Treatment Trial.","BACKGROUND


Although inhaled therapy reduces exacerbations among patients with COPD, the effectiveness of providing inhaled treatment per risk stratification models remains unclear.
RESEARCH QUESTION


Are inhaled regimens that align with the 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy associated with clinically important outcomes?
STUDY DESIGN AND METHODS


We conducted secondary analyses of Long-term Oxygen Treatment Trial (LOTT) data. The trial enrolled patients with COPD with moderate resting or exertional hypoxemia between 2009 and 2015. Our exposure was the patient-reported inhaled regimen at enrollment, categorized as either aligning with, undertreating, or potentially overtreating per the 2017 GOLD strategy. Our primary composite outcome was time to death or first hospitalization for COPD. Additional outcomes included individual components of the composite outcome and time to first exacerbation. We generated multivariable Cox proportional hazard models across strata of GOLD-predicted exacerbation risk (high vs low) to estimate between-group hazard ratios for time to event outcomes. We adjusted models a priori for potential confounders, clustered by site.
RESULTS


The trial enrolled 738 patients (73.4% men; mean age, 68.8 years). Of the patients, 571 (77.4%) were low risk for future exacerbations. Of the patients, 233 (31.6%) reported regimens aligning with GOLD recommendations; most regimens (54.1%) potentially overtreated. During a 2.3-year median follow-up, 332 patients (44.9%) experienced the composite outcome. We found no difference in time to composite outcome or death among patients reporting regimens aligning with recommendations compared with undertreated patients. Among patients at low risk, potential overtreatment was associated with higher exacerbation risk (hazard ratio, 1.42; 95% CI, 1.09-1.87), whereas inhaled corticosteroid treatment was associated with 64% higher risk of pneumonia (incidence rate ratio, 1.64; 95% CI, 1.01-2.66).
INTERPRETATION


Among patients with COPD with moderate hypoxemia, we found no difference in clinical outcomes between inhaled regimens aligning with the 2017 GOLD strategy compared with those that were undertreated. These findings suggest the need to reevaluate the effectiveness of risk stratification model-based inhaled treatment strategies.",2020,We found no difference in time-to composite outcome or death among patients reporting regimens aligning with recommendations compared to undertreated patients.,"['COPD patients with moderate hypoxemia', 'enrolled COPD patients with moderate resting or exertional hypoxemia between 2009-2015', 'and Methods', 'COPD patients', '571 patients (77.4%) were low-risk for future exacerbations', '738 patients; 73.4% were male with mean age 68.8 years']",[],"['individual components of the composite outcome and time-to first exacerbation', 'exacerbation risk', 'COPD Inhaler Regimenswith Mortality, Respiratory Exacerbations, and Quality of Life', 'risk of pneumonia', 'time-to composite outcome or death', 'time-to death or first hospitalization for COPD']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",738.0,0.234867,We found no difference in time-to composite outcome or death among patients reporting regimens aligning with recommendations compared to undertreated patients.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA. Electronic address: tlk33@uw.edu.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Spece', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Donovan', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Edmunds', 'Initials': 'E', 'LastName': 'Udris', 'Affiliation': 'Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Coggeshall', 'Affiliation': 'Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Griffith', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Bryant', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'J Allen', 'Initials': 'JA', 'LastName': 'Cooper', 'Affiliation': 'Birmingham VA Medical Center and the Lung Health Center, University of Alabama Birmingham, Birmingham, AL.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Temple University School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Philip T', 'Initials': 'PT', 'LastName': 'Diaz', 'Affiliation': '201 Heart Lung Institute, Ohio State University School of Medicine, Columbus, OH.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Fuhlbrigge', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Gay', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor, MI.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Kanner', 'Affiliation': 'University of Utah Health Sciences Center, Salt Lake City, UT.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'Panos', 'Affiliation': 'Cincinnati VA Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shade', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sternberg', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stibolt', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Stoller', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Yusen', 'Affiliation': 'Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Feemster', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}]",Chest,['10.1016/j.chest.2020.02.073']
306,32278781,"Effect of Venlafaxine on Apnea-Hypopnea Index in Patients With Sleep Apnea: A Randomized, Double-Blind Crossover Study.","BACKGROUND


One of the key mechanisms underlying OSA is reduced pharyngeal muscle tone during sleep. Data suggest that pharmacologic augmentation of central serotonergic/adrenergic tone increases pharyngeal muscle tone.
RESEARCH QUESTION


We hypothesized that venlafaxine, a serotonin-norepinephrine reuptake inhibitor, would improve OSA severity.
STUDY DESIGN AND METHODS


In this mechanistic, randomized, double-blind, placebo-controlled crossover trial, 20 patients with OSA underwent two overnight polysomnograms ≥ 4 days apart, receiving either 50 mg of immediate-release venlafaxine or placebo before bedtime. Primary outcomes were the apnea-hypopnea index (AHI) and peripheral oxygen saturation (Spo 2 ) nadir, and secondary outcomes included sleep parameters and pathophysiologic traits with a view toward understanding the impact of venlafaxine on mechanisms underlying OSA.
RESULTS


Overall, there was no significant difference between venlafaxine and placebo regarding AHI (mean reduction, -5.6 events/h [95% CI, -12.0 to 0.9]; P = .09) or Spo 2  nadir (median increase, +1.0% [-0.5 to 5]; P = .11). Venlafaxine reduced total sleep time, sleep efficiency, and rapid eye movement (REM) sleep, while increasing non-REM stage 1 sleep (P all  < .05). On the basis of exploratory post hoc analyses venlafaxine decreased (""improved"") the ventilatory response to arousal (-30%; P = .049) and lowered (""worsened"") the predicted arousal threshold (-13%; [P = .02]; ie, more arousable), with no effects on other pathophysiologic traits (P all  ≥ .3). Post hoc analyses further suggested effect modification by arousal threshold (P = .002): AHI improved by 19% in patients with a high arousal threshold (-10.9 events/h [-3.9 to -17.9]) but tended to increase in patients with a low arousal threshold (+7 events/h [-2.0 to 16]). Other predictors of response were elevated AHI and less collapsible upper airway anatomy at baseline (|r| > 0.5, P ≤ .02).
INTERPRETATION


In unselected patients, venlafaxine simultaneously worsened and improved various pathophysiologic traits, resulting in a zero net effect. Careful patient selection based on pathophysiologic traits, or combination therapy with drugs countering its alerting effects, may produce a more robust response.
TRIAL REGISTRY


ClinicalTrials.gov; No.: NCT02714400; URL: www.clinicaltrials.gov.",2020,"Based on exploratory post hoc analyses venlafaxine decreased (""improved"") the ventilatory response to arousal (-30%, P=.049) and lowered (""worsened"") the predicted arousal threshold (-13%, P=.02; i.e. more arousable), with no effects on other pathophysiological traits (P all ≥.3).","['and Methods', 'obstructive sleep apnea (OSA', 'Patients with Sleep Apnea ', '20 OSA patients underwent two', 'patients with a high arousal threshold (-10.9/h']","['venlafaxine', 'Venlafaxine', 'overnight polysomnograms >4days apart receiving either 50mg immediate-release venlafaxine or placebo', 'placebo']","['Apnea Hypopnea Index', 'ventilatory response to arousal', 'total sleep time, sleep efficiency and rapid eye movement (REM) sleep', 'pathophysiological traits', 'apnea hypopnea index (AHI) and SpO 2  nadir; secondary outcomes included sleep parameters and pathophysiological traits with a view towards understanding its impact on mechanisms underlying OSA']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]","[{'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",20.0,0.290939,"Based on exploratory post hoc analyses venlafaxine decreased (""improved"") the ventilatory response to arousal (-30%, P=.049) and lowered (""worsened"") the predicted arousal threshold (-13%, P=.02; i.e. more arousable), with no effects on other pathophysiological traits (P all ≥.3).","[{'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Schmickl', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Yanru', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA; Department of Otorhinolaryngology Head and Neck Surgery, Sleep Medicine Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China. Electronic address: liyanruru@aliyun.com.'}, {'ForeName': 'Jeremy E', 'Initials': 'JE', 'LastName': 'Orr', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jen', 'Affiliation': 'Division of Respiratory Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Edwards', 'Affiliation': 'Sleep and Circadian Medicine Laboratory, Department of Physiology, School of Biomedical Sciences and Biomedical Discovery Institute, Monash University, Melbourne, VIC, Australia; Turner Institute for Brain and Mental Health, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'DeYoung', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}]",Chest,['10.1016/j.chest.2020.02.074']
307,32271970,Tofacitinib in psoriatic arthritis patients: skin signs and symptoms and health-related quality of life from two randomized phase 3 studies.,"BACKGROUND


Psoriatic arthritis (PsA) is a chronic, systemic immune-mediated inflammatory musculoskeletal disease. The onset of dermatologic symptoms often precedes rheumatic manifestations. Tofacitinib is an oral Janus kinase inhibitor for the treatment of PsA that has been shown to improve dermatologic symptoms in patients with PsA.
OBJECTIVES


To investigate the efficacy of tofacitinib in improving dermatologic endpoints in adult patients with active PsA.
METHODS


This analysis included data from two placebo-controlled, double-blind, phase 3 studies in patients with active PsA and an inadequate response (IR) to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) who were tumor necrosis factor inhibitor (TNFi)-naïve (OPAL Broaden; NCT01877668) or an IR to ≥1 TNFi (OPAL Beyond; NCT01882439). Patients had active plaque psoriasis at screening and received a stable dose of one csDMARD during the study. Patients were randomized to tofacitinib 5 mg twice daily (BID), 10 mg BID, adalimumab 40 mg subcutaneous injection once every 2 weeks (OPAL Broaden only) or placebo (to Month 3). Dermatologic endpoints: Psoriasis Area and Severity Index (PASI) total score; PASI90 overall; PASI75 and PASI90 by baseline PASI severity; Physician's Global Assessment of Psoriasis; Nail Psoriasis Severity Index; Dermatology Life Quality Index total and sub-dimension scores; Itch Severity Item; and Patient's Global Joint and Skin Assessment-Visual Analog Scale-Psoriasis question.
RESULTS


In patients with active PsA, including those stratified by mild or moderate/severe dermatologic symptoms, greater improvements from baseline and percentage of responders were observed in tofacitinib-treated patients vs. placebo for the majority of analyzed dermatologic endpoints at Months 1 and 3, and improvements were maintained to Month 12 in OPAL Broaden and Month 6 in OPAL Beyond. Similar effects were observed in adalimumab-treated patients vs. placebo in OPAL Broaden across dermatologic endpoints.
CONCLUSIONS


Tofacitinib provides a treatment option for patients with active PsA, including the burdensome dermatologic symptoms of PsA.",2020,"Similar effects were observed in adalimumab-treated patients vs. placebo in OPAL Broaden across dermatologic endpoints.
","['patients with active PsA, including the burdensome dermatologic symptoms of PsA', 'adult patients with active PsA.\nMETHODS', 'Patients had active plaque psoriasis at screening and received a stable dose of one csDMARD during the study', 'patients with active PsA and an inadequate response (IR) to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) who were tumor necrosis factor inhibitor', 'patients with PsA', 'psoriatic arthritis patients']","['tofacitinib', 'Tofacitinib', 'placebo', 'adalimumab 40\xa0mg subcutaneous injection once every 2 weeks (OPAL Broaden only) or placebo']","['severe dermatologic symptoms', ""Dermatologic endpoints: Psoriasis Area and Severity Index (PASI) total score; PASI90 overall; PASI75 and PASI90 by baseline PASI severity; Physician's Global Assessment of Psoriasis; Nail Psoriasis Severity Index; Dermatology Life Quality Index total and sub-dimension scores; Itch Severity Item; and the Psoriasis question from Patient's Global Joint and Skin Assessment-Visual Analog Scale"", 'dermatologic symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205489', 'cui_str': 'Dermatologic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0084990', 'cui_str': 'VPDA protocol'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205489', 'cui_str': 'Dermatologic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0406322', 'cui_str': 'Psoriasis of nail'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0558035', 'cui_str': 'Skin assessment'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.502344,"Similar effects were observed in adalimumab-treated patients vs. placebo in OPAL Broaden across dermatologic endpoints.
","[{'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Merola', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research and K Papp Clinical Research Inc, Waterloo, ON, Canada.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Nash', 'Affiliation': 'Department of Medicine, Griffith University, Brisbane, QLD, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gratacós', 'Affiliation': 'Servicio de Reumatología, Hospital Universitari Parc Taulí Sabadell, Barcelona, Spain.'}, {'ForeName': 'W H', 'Initials': 'WH', 'LastName': 'Boehncke', 'Affiliation': 'Division of Dermatology and Venereology, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Graham', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'M-A', 'Initials': 'MA', 'LastName': 'Hsu', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Pfizer Inc, Collegeville, PA, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16433']
308,32088207,A Randomized Placebo-Controlled Trial of Secukinumab on Aortic Vascular Inflammation in Moderate-to-Severe Plaque Psoriasis (VIP-S).,"Psoriasis, a chronic immune-mediated disease, is associated with an increased risk of cardiovascular events and mortality. Secukinumab selectively neutralizes IL-17A and has reported high efficacy with a favorable safety profile in various psoriatic disease manifestations. Subsequent to the 12-week randomized, placebo-controlled, double-blind treatment period, patients with moderate-to-severe psoriasis received secukinumab for 40 weeks. Vascular inflammation using  18 F-2-fluorodeoxyglucose-positron emission tomography/computed tomography imaging and blood-based cardiometabolic was assessed at week 0, 12, and 52. The difference in change in aortic inflammation from baseline to week 12 for secukinumab (n = 46) versus placebo (n = 45) was -0.053 (95% confidence interval = -0.169 to 0.064; P= 0.37). Small increases in total cholesterol, low-density lipoprotein, and low-density lipoprotein particles, but no changes in markers of inflammation, adiposity, insulin resistance, or predictors of diabetes, were observed with secukinumab treatment compared with placebo. At week 52, reductions in TNF-α (P= 0.0063) and ferritin (P= 0.0354), and an increase in fetuin-A (P= 0.0024), were observed with secukinumab treatment compared with baseline. No significant changes in aortic inflammation or markers of advanced lipoprotein characterization, adiposity, or insulin resistance were observed with secukinumab treatment compared with baseline. Secukinumab exhibited a neutral impact on aortic vascular inflammation and biomarkers of cardiometabolic disease after 52 weeks of treatment.",2020,"At Week 52, reductions in TNF-α (P=0.0063) and ferritin (P=0.0354), and an increase in fetuin A (P=0.0024), were observed with secukinumab treatment compared to baseline.","['Moderate to Severe Plaque Psoriasis (VIP-S', 'moderate-to-severe psoriasis patients received secukinumab for 40 weeks']","['placebo', 'Secukinumab', 'Placebo']","['Aortic Vascular Inflammation', 'aortic vascular inflammation and biomarkers of cardiometabolic disease', 'TNF-α', 'aortic inflammation', 'markers of inflammation, adiposity, insulin resistance, or predictors of diabetes', 'total cholesterol, LDL, and LDL particles', 'aortic inflammation or markers of advanced lipoprotein characterization, adiposity, or insulin resistance', 'Vascular inflammation using FDG-PET/CT imaging and blood-based cardiometabolic']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0042395', 'cui_str': 'VIP'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}]","[{'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0947751', 'cui_str': 'Vascular inflammations'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}, {'cui': 'C0005768'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",,0.536985,"At Week 52, reductions in TNF-α (P=0.0063) and ferritin (P=0.0354), and an increase in fetuin A (P=0.0024), were observed with secukinumab treatment compared to baseline.","[{'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Gelfand', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA. Electronic address: Joel.Gelfand@pennmedicine.upenn.edu.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Shin', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Kristina Callis', 'Initials': 'KC', 'LastName': 'Duffin', 'Affiliation': 'University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'April W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'Keck School of Medicine of USC, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, Oregon, USA.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Tyring', 'Affiliation': 'Department of Dermatology, University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Division of Dermatology, Baylor Scott &White, Dallas, Texas, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Gottlieb', 'Affiliation': 'Dermatology and Skin Surgery Center, Exton, Pennsylvania, USA.'}, {'ForeName': 'Benjamin N', 'Initials': 'BN', 'LastName': 'Lockshin', 'Affiliation': 'DermAssociates, Rockville, Maryland, USA.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'OSHU Dermatology Clinic, South Waterfront, Portland, Oregon, USA.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Kianifard', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Rajendra Prasad', 'Initials': 'RP', 'LastName': 'Sarkar', 'Affiliation': 'Novartis Business Services, Novartis Healthcare Pvt Ltd, Hyderabad, India.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Muscianisi', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Steadman', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ahlman', 'Affiliation': 'Radiology and Imaging Sciences, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Playford', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Aditya A', 'Initials': 'AA', 'LastName': 'Joshi', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Amit K', 'Initials': 'AK', 'LastName': 'Dey', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Werner', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Abass', 'Initials': 'A', 'LastName': 'Alavi', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nehal N', 'Initials': 'NN', 'LastName': 'Mehta', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.'}]",The Journal of investigative dermatology,['10.1016/j.jid.2020.01.025']
309,32267724,"Targeted Retreatment of Incompletely Recovered Chronic Obstructive Pulmonary Disease Exacerbations with Ciprofloxacin. A Double-Blind, Randomized, Placebo-controlled, Multicenter, Phase III Clinical Trial.","Rationale:  Chronic obstructive pulmonary disease (COPD) exacerbations are prone to nonrecovery, but there are no data about the effectiveness of retreatment for these prolonged events. We examined whether further therapy with ciprofloxacin for incompletely resolved COPD exacerbations prolonged the time until the next event. Objectives:  To assess whether incompletely recovered COPD exacerbations benefit from additional treatment with ciprofloxacin, at Day 14. Methods:  In a multicenter, randomized double-blind placebo-controlled trial, we studied retreatment with oral ciprofloxacin 500 mg or matched placebo twice daily for 7 days in patients with Global Initiative for Chronic Obstructive Lung Disease stage II-IV COPD and persistent symptoms and/or serum C-reactive protein ≥8 mg/L initiated 14 (±3) days after an index COPD exacerbation. The primary outcome was the time to the next exacerbation within a 90-day period. Measurements and Main Results:  Among 826 patients screened at four centers, 144 eligible participants with incomplete recovery were randomized to receive ciprofloxacin ( n  = 72) or placebo ( n  = 72). Within 90 days of randomization, 57% of the patients in the ciprofloxacin group and 53% in the placebo group experienced one or more exacerbations. The median time to the next exacerbation was 32.5 days (interquartile range 13-50) in the placebo arm and 34 days (interquartile range 17-62) in the ciprofloxacin arm, which was not significantly different (adjusted hazard ratio, 1.07; 95% confidence interval, 0.68-1.68;  P  = 0.76). No significant differences were seen in quality-of-life scores or lung function between the treatment groups. Conclusions:  In patients with persistent symptoms and/or raised C-reactive protein 14 days after a COPD exacerbation, an additional course of ciprofloxacin resulted in no additional benefit compared with placebo. This suggests that nonrecovered exacerbations are not driven by ongoing bacterial infection and may potentially be targeted with antiinflammatory therapy.Clinical trial registered with www.clinicaltrials.gov (NCT02300220).",2020,"57% of patients in the ciprofloxacin group had experienced 1 or more exacerbations, compared to 53% in the placebo group.","['826 patients screened at 4 centres', '144 eligible participants with incomplete recovery', 'patients with GOLD stage II - IV COPD with persistent symptoms and/or serum C-reactive protein (CRP']","['oral ciprofloxacin 500mg or matched placebo', 'placebo', 'Ciprofloxacin', 'ciprofloxacin', 'Placebo']","['exacerbations', 'median time to the next exacerbation', 'COPD Exacerbations', 'time to the next exacerbation within a 90-day period', 'quality of life scores or lung function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1123173', 'cui_str': 'Ciprofloxacin 500 MG'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.771152,"57% of patients in the ciprofloxacin group had experienced 1 or more exacerbations, compared to 53% in the placebo group.","[{'ForeName': 'Andrew I', 'Initials': 'AI', 'LastName': 'Ritchie', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Simon E', 'Initials': 'SE', 'LastName': 'Brill', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Ben H', 'Initials': 'BH', 'LastName': 'Vlies', 'Affiliation': 'School of Aging and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Lydia J', 'Initials': 'LJ', 'LastName': 'Finney', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Allinson', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Alves-Moreira', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Dexter J', 'Initials': 'DJ', 'LastName': 'Wiseman', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Walker', 'Affiliation': 'School of Aging and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Baker', 'Affiliation': ""Institute of Infection and Immunity, St. George's, University of London, London, United Kingdom.""}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Elkin', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, United Kingdom; and.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mallia', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Law', 'Affiliation': 'Hub for Trials Methodology Research, Medical Research Council Biostatistics Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Gavin C', 'Initials': 'GC', 'LastName': 'Donaldson', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'School of Aging and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, United Kingdom.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201910-2058OC']
310,32243379,The microcirculatory characteristics of the heart and lung meridians: Study protocol clinical trial (SPIRIT Compliant).,"INTRODUCTION


The aim of the present study is to compare the microcirculatory difference of different meridians by using laser doppler flowmetry and investigate the specificity for the meridian-visceral association and site-to-site association between 2 specific meridians.
METHODS AND ANALYSIS


The Lung and Heart meridians are chosen as 2 specific studied meridians. 120 participants will be enrolled and divided into the healthy control group, chronic stable angina pectoris group and healthy intervention group. Laser doppler flowmetry will be used to assess the blood perfusion of the Heart and Lung meridians. The specificity for the meridian-visceral association will be investigated by comparing the microcirculatory difference between the Heart and Lung meridians in the healthy control group and chronic stable angina pectoris group. Besides, participants in the healthy intervention group will receive 2 sessions of moxibustion in the Heart meridian and Lung meridian, respectively, to explore the specificity for the site-to-site association on the body surface. Primary outcomes will be blood flow curve and blood perfusion units of relevant sites along the Heart and Lung meridians. Statistical analysis will be conducted by third party statisticians.
ETHICS AND DISSEMINATION


Ethics approval (approval No: ZSLL-KY-2019-001A-01) has been obtained from the Ethics Committee of the Third Affiliated Hospital of Zhejiang Chinese Medical University. The study findings will be disseminated through presentation at peer-reviewed medical journals.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04244812.",2020,"120 participants will be enrolled and divided into the healthy control group, chronic stable angina pectoris group and healthy intervention group.","['120 participants will be enrolled and divided into the healthy control group, chronic stable angina pectoris group and healthy intervention group']","['laser doppler flowmetry', 'Laser doppler flowmetry']",['blood flow curve and blood perfusion units of relevant sites along the Heart and Lung meridians'],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0162520', 'cui_str': 'Laser doppler flowmetry'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0085282', 'cui_str': 'Jingluo'}]",120.0,0.0346416,"120 participants will be enrolled and divided into the healthy control group, chronic stable angina pectoris group and healthy intervention group.","[{'ForeName': 'Hantong', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou City, Zhejiang Province.'}, {'ForeName': 'Yongliang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Lou', 'Affiliation': 'Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Xiaofen', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Junfan', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou City, Zhejiang Province.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Shao', 'Affiliation': 'Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou, China.'}, {'ForeName': 'Jianqiao', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou, China.'}]",Medicine,['10.1097/MD.0000000000019594']
311,32269109,Scrambler therapy improves pain in neuromyelitis optica: A randomized controlled trial.,"OBJECTIVE


To determine whether Scrambler therapy is an effective, acceptable, and feasible treatment of persistent central neuropathic pain in patients with neuromyelitis optica spectrum disorder (NMOSD) and to explore the effect of Scrambler therapy on co-occurring symptoms.
METHODS


We conducted a randomized single-blind, sham-controlled trial in patients with NMOSD who have central neuropathic pain using Scrambler therapy for 10 consecutive weekdays. Pain severity, pain interference, anxiety, depression, and sleep disturbance were assessed at baseline, at the end of treatment, and at the 30- and 60-day follow-up.
RESULTS


Twenty-two patients (11 per arm) were enrolled in and completed this trial. The median baseline numeric rating scale (NRS) pain score decreased from 5.0 to 1.5 after 10 days of treatment with Scrambler therapy, whereas the median NRS score did not significantly decrease in the sham arm. Depression was also reduced in the treatment arm, and anxiety was decreased in a subset of patients who responded to treatment. These symptoms were not affected in the sham arm. The safety profiles were similar between groups.
CONCLUSIONS


Scrambler therapy is an effective, feasible, and safe intervention for central neuropathic pain in patients with NMOSD. Decreasing pain with Scrambler therapy may additionally improve depression and anxiety.
CLINICALTRIALSGOV IDENTIFIER


NCT03452176.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that Scrambler therapy significantly reduces pain in patients with NMOSD and persistent central neuropathic pain.",2020,"The median baseline numeric rating scale (NRS) pain score decreased from 5.0 to 1.5 after 10 days of treatment with Scrambler therapy, whereas the median NRS score did not significantly decrease in the sham arm.","['patients with NMOSD and persistent central neuropathic pain', 'Twenty-two patients (11 per arm) were enrolled in and completed this trial', 'patients with neuromyelitis optica spectrum disorder (NMOSD', 'patients with NMOSD', 'patients with NMOSD who have central neuropathic pain using Scrambler therapy for 10 consecutive weekdays']",['Scrambler therapy'],"['anxiety', 'Pain severity, pain interference, anxiety, depression, and sleep disturbance', 'central neuropathic pain', 'median NRS score', 'Depression', 'depression and anxiety', 'pain', 'median baseline numeric rating scale (NRS) pain score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C4087506', 'cui_str': 'Central neuropathic pain'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027873', 'cui_str': 'Neuromyelitis optica'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C4087506', 'cui_str': 'Central neuropathic pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",22.0,0.37789,"The median baseline numeric rating scale (NRS) pain score decreased from 5.0 to 1.5 after 10 days of treatment with Scrambler therapy, whereas the median NRS score did not significantly decrease in the sham arm.","[{'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Mealy', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA. mmealy1@jhmi.edu.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Kozachik', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Cook', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Totonis', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Ruth Andrea', 'Initials': 'RA', 'LastName': 'Salazar', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Jerilyn K', 'Initials': 'JK', 'LastName': 'Allen', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Nolan', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Smith', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Levy', 'Affiliation': 'From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}]",Neurology,['10.1212/WNL.0000000000009370']
312,31444776,An Extended Pouch in a Roux-En-Y Gastric Bypass Reduces Weight Regain: 3-Year Results of a Randomized Controlled Trial.,"BACKGROUND


Although the Roux-en-Y gastric bypass (RYGB) is considered a standard procedure, many variations exist in the basic design. In order to achieve more pronounced and sustainable results after RYGB, factors such as diameter of the gastroenterostomy, limb length, and pouch size are gripping points for improvement of design. Extending the pouch could improve results by altering food passage through the pouch.
OBJECTIVE


The aim of this randomized controlled trial was to evaluate the effect of an extended pouch RYGB (EP-GB) and standard pouch RYGB (S-GB).
METHODS


In total, 132 patients were randomized in two groups: 68 patients received an EP-GB (pouch length 10 cm) and 64 a S-GB (pouch length 5 cm). Subsequently, weight loss, remission of comorbidities, nutritional status, complications, quality of life, and GERD-symptoms were assessed during a follow-up of 3 years.
RESULTS


During the first 2 years of follow-up, no significant differences in terms of weight loss were observed. In the third year of follow-up, the S-GB group regained 3 kg, while in the EP-GB group no weight regain was observed. The mean TBWL after 36 months in the EP-GB group was 31% versus 27% in the S-GB group (p = 0.023). Additionally, besides a better remission rate of hypertension in the EP-GB group, no differences in complications, quality of life, and GERD-symptoms were found.
CONCLUSION


Creation of an extended gastric pouch is a safe and effective modification in RYGB design. An EP-GB improves mid-term weight loss, potentially driven by a lower occurrence of weight regain.",2020,"During the first 2 years of follow-up, no significant differences in terms of weight loss were observed.",['132 patients were randomized in two groups: 68 patients received an'],"['Roux-en-Y gastric bypass (RYGB', 'EP-GB', 'Roux-En-Y Gastric Bypass', 'extended pouch RYGB (EP-GB) and standard pouch RYGB (S-GB']","['remission rate of hypertension', 'weight loss', 'mean TBWL', 'weight loss, remission of comorbidities, nutritional status, complications, quality of life, and GERD-symptoms', 'weight regain', 'complications, quality of life, and GERD-symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C4319584', 'cui_str': 'Pouch (unit of presentation)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0034380'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",132.0,0.0474195,"During the first 2 years of follow-up, no significant differences in terms of weight loss were observed.","[{'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Boerboom', 'Affiliation': 'Department of Surgery, Rijnstate Hospital, Postal number 1190, 6800TA, Arnhem, The Netherlands. aboerboom2@rijnstate.nl.'}, {'ForeName': 'Mellody', 'Initials': 'M', 'LastName': 'Cooiman', 'Affiliation': 'Department of Surgery, Rijnstate Hospital, Postal number 1190, 6800TA, Arnhem, The Netherlands.'}, {'ForeName': 'Edo', 'Initials': 'E', 'LastName': 'Aarts', 'Affiliation': 'Department of Surgery, Rijnstate Hospital, Postal number 1190, 6800TA, Arnhem, The Netherlands.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Aufenacker', 'Affiliation': 'Department of Surgery, Rijnstate Hospital, Postal number 1190, 6800TA, Arnhem, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Hazebroek', 'Affiliation': 'Department of Surgery, Rijnstate Hospital, Postal number 1190, 6800TA, Arnhem, The Netherlands.'}, {'ForeName': 'Frits', 'Initials': 'F', 'LastName': 'Berends', 'Affiliation': 'Department of Surgery, Rijnstate Hospital, Postal number 1190, 6800TA, Arnhem, The Netherlands.'}]",Obesity surgery,['10.1007/s11695-019-04156-0']
313,32078683,Effect of Intravenous Tenecteplase Dose on Cerebral Reperfusion Before Thrombectomy in Patients With Large Vessel Occlusion Ischemic Stroke: The EXTEND-IA TNK Part 2 Randomized Clinical Trial.,"Importance


Intravenous thrombolysis with tenecteplase improves reperfusion prior to endovascular thrombectomy for ischemic stroke compared with alteplase.
Objective


To determine whether 0.40 mg/kg of tenecteplase safely improves reperfusion before endovascular thrombectomy vs 0.25 mg/kg of tenecteplase in patients with large vessel occlusion ischemic stroke.
Design, Setting, and Participants


Randomized clinical trial at 27 hospitals in Australia and 1 in New Zealand using open-label treatment and blinded assessment of radiological and clinical outcomes. Patients were enrolled from December 2017 to July 2019 with follow-up until October 2019. Adult patients (N = 300) with ischemic stroke due to occlusion of the intracranial internal carotid, \basilar, or middle cerebral artery were included less than 4.5 hours after symptom onset using standard intravenous thrombolysis eligibility criteria.
Interventions


Open-label tenecteplase at 0.40 mg/kg (maximum, 40 mg; n = 150) or 0.25 mg/kg (maximum, 25 mg; n = 150) given as a bolus before endovascular thrombectomy.
Main Outcomes and Measures


The primary outcome was reperfusion of greater than 50% of the involved ischemic territory prior to thrombectomy, assessed by consensus of 2 blinded neuroradiologists. Prespecified secondary outcomes were level of disability at day 90 (modified Rankin Scale [mRS] score; range, 0-6); mRS score of 0 to 1 (freedom from disability) or no change from baseline at 90 days; mRS score of 0 to 2 (functional independence) or no change from baseline at 90 days; substantial neurological improvement at 3 days; symptomatic intracranial hemorrhage within 36 hours; and all-cause death.
Results


All 300 patients who were randomized (mean age, 72.7 years; 141 [47%] women) completed the trial. The number of participants with greater than 50% reperfusion of the previously occluded vascular territory was 29 of 150 (19.3%) in the 0.40 mg/kg group vs 29 of 150 (19.3%) in the 0.25 mg/kg group (unadjusted risk difference, 0.0% [95% CI, -8.9% to -8.9%]; adjusted risk ratio, 1.03 [95% CI, 0.66-1.61]; P = .89). Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
Conclusions and Relevance


Among patients with large vessel occlusion ischemic stroke, a dose of 0.40 mg/kg, compared with 0.25 mg/kg, of tenecteplase did not significantly improve cerebral reperfusion prior to endovascular thrombectomy. The findings suggest that the 0.40-mg/kg dose of tenecteplase does not confer an advantage over the 0.25-mg/kg dose in patients with large vessel occlusion ischemic stroke in whom endovascular thrombectomy is planned.
Trial Registration


ClinicalTrials.gov Identifier: NCT03340493.",2020,"Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
","['Adult patients (N\u2009=\u2009300) with ischemic stroke due to occlusion of the intracranial internal carotid, \\basilar, or middle cerebral artery were included less than 4.5 hours after symptom onset using standard intravenous thrombolysis eligibility criteria', 'All 300 patients who were randomized (mean age, 72.7 years; 141 [47%] women) completed the trial', 'Patients With Large Vessel Occlusion Ischemic Stroke', 'Patients were enrolled from December 2017 to July 2019 with follow-up until October 2019', '27 hospitals in Australia and 1 in New Zealand using open-label treatment and blinded assessment of radiological and clinical outcomes', 'patients with large vessel occlusion ischemic stroke']","['Interventions\n\n\nOpen-label tenecteplase at 0.40 mg/kg (maximum, 40 mg; n\u2009=\u2009150) or 0.25 mg/kg']","['Cerebral Reperfusion', 'occluded vascular territory', 'cause deaths', 'symptomatic intracranial hemorrhage', 'cerebral reperfusion', '4 functional outcomes', 'reperfusion of greater than 50% of the involved ischemic territory prior to thrombectomy', 'level of disability at day 90 (modified Rankin Scale [mRS] score; range, 0-6); mRS score of 0 to 1 (freedom from disability) or no change from baseline at 90 days; mRS score of 0 to 2 (functional independence) or no change from baseline at 90 days; substantial neurological improvement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0225990', 'cui_str': 'Large vessel'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0872913', 'cui_str': 'Tenecteplase'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}]","[{'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",,0.594367,"Among the 6 secondary outcomes, there were no significant differences in any of the 4 functional outcomes between the 0.40 mg/kg and 0.25 mg/kg groups nor in all-cause deaths (26 [17%] vs 22 [15%]; unadjusted risk difference, 2.7% [95% CI, -5.6% to 11.0%]) or symptomatic intracranial hemorrhage (7 [4.7%] vs 2 [1.3%]; unadjusted risk difference, 3.3% [95% CI, -0.5% to 7.2%]).
","[{'ForeName': 'Bruce C V', 'Initials': 'BCV', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Mitchell', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Churilov', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Nawaf', 'Initials': 'N', 'LastName': 'Yassi', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kleinig', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Dowling', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Bush', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Thijs', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Scroop', 'Affiliation': 'Department of Radiology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Simpson', 'Affiliation': 'Department of Neurology, Austin Hospital, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brooks', 'Affiliation': 'Department of Radiology, Austin Hospital, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Asadi', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Teddy Y', 'Initials': 'TY', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Darshan G', 'Initials': 'DG', 'LastName': 'Shah', 'Affiliation': 'Department of Neurology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Tissa', 'Initials': 'T', 'LastName': 'Wijeratne', 'Affiliation': 'Melbourne Medical School, Department of Medicine and Neurology, The University of Melbourne and Western Health, Sunshine Hospital, St Albans Victoria, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Fana', 'Initials': 'F', 'LastName': 'Alemseged', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ng', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bailey', 'Affiliation': 'Department of Neurology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Rice', 'Affiliation': 'Department of Radiology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'de Villiers', 'Affiliation': 'Department of Radiology, Gold Coast University Hospital, Southport, Queensland, Australia.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Dewey', 'Affiliation': 'Eastern Health and Eastern Health Clinical School, Department of Neurosciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Philip M C', 'Initials': 'PMC', 'LastName': 'Choi', 'Affiliation': 'Eastern Health and Eastern Health Clinical School, Department of Neurosciences, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'Department of Neurology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kendal', 'Initials': 'K', 'LastName': 'Redmond', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leggett', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Fink', 'Affiliation': 'Department of Neurology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Collecutt', 'Affiliation': 'Department of Radiology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Medicine, Ballarat Base Hospital, Ballarat, Victoria, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Krause', 'Affiliation': 'Department of Neurology, Royal North Shore Hospital and Kolling Institute, University of Sydney, St Leonards, New South Wales, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Cordato', 'Affiliation': 'Department of Neurology, Liverpool Hospital, Liverpool, New South Wales, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Field', 'Affiliation': 'Department of Neurology, Lyell McEwin Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'School of Clinical Sciences, Department of Medicine, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Neurology, Gosford Hospital, Gosford, New South Wales, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Clissold', 'Affiliation': 'Department of Neurology, University Hospital Geelong, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Miteff', 'Affiliation': 'Department of Neurology, Priority Research Centre for Brain and Mental Health Research, John Hunter Hospital, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Clissold', 'Affiliation': 'Department of Medicine, Southwest Healthcare, Warrnambool, Victoria, Australia.'}, {'ForeName': 'Geoffrey C', 'Initials': 'GC', 'LastName': 'Cloud', 'Affiliation': 'Department of Neurology, Alfred Hospital, Prahran, Victoria, Australia.'}, {'ForeName': 'Leslie E', 'Initials': 'LE', 'LastName': 'Bolitho', 'Affiliation': 'Department of Medicine, Northeast Health, Wangaratta, Victoria, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Bonavia', 'Affiliation': 'Department of Medicine, Albury Base Hospital, Albury, New South Wales, Australia.'}, {'ForeName': 'Arup', 'Initials': 'A', 'LastName': 'Bhattacharya', 'Affiliation': 'Department of Medicine, Goulburn Valley Health, Shepparton, Victoria, Australia.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': 'Department of Medicine, Latrobe Regional Health, Traralgon, Victoria, Australia.'}, {'ForeName': 'Abul', 'Initials': 'A', 'LastName': 'Mamun', 'Affiliation': 'Department of Medicine, Campbelltown Hospital, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Fintan', 'Initials': 'F', 'LastName': ""O'Rourke"", 'Affiliation': 'Department of Aged Care and Rehabilitation, Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Worthington', 'Affiliation': 'Department of Neurology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Wong', 'Affiliation': ""Department of Neurology, Royal Brisbane and Women's Hospital and the University of Queensland, Brisbane, Queensland, Australia.""}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'Maridulu budyari gumal, The Sydney Partnership for Health Education Research & Enterprise (SPHERE), University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Christopher F', 'Initials': 'CF', 'LastName': 'Bladin', 'Affiliation': 'The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Gagan', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Desmond', 'Affiliation': 'Department of Radiology, the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Donnan', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.1511']
314,32080797,Feasibility and Preliminary Efficacy of a Bright Light Intervention in Ovarian and Endometrial Cancer Survivors.,"BACKGROUND


Cancer-related sleep disturbance is common and can adversely affect physical and mental health. Bright light (BL) therapy is a novel intervention that targets sleep by promoting circadian regulation. Emerging evidence suggests BL can improve sleep disturbance, symptom burden, and health-related quality of life in cancer and other populations; however, this research is limited. The present two-phase pilot study assessed the feasibility and preliminary intended effects of BL therapy on sleep in ovarian and endometrial cancer survivors, and explored biologic and chronobiologic factors that may underlie intervention effects.
METHODS


In phase I, focus groups were conducted with 12 survivors and 9 gynecologic oncology clinicians to evaluate and gather feedback about the proposed study. In phase II, a pilot randomized controlled trial was conducted with 18 ovarian or endometrial cancer survivors who were randomized 1:1 to receive 45 min of BL or dim light (DL) for 4 weeks. Participants wore wrist actigraphs; completed sleep diaries and self-report questionnaires; and provided blood, saliva, and urine samples at baseline (T1), post-intervention (T2), and 3-month follow-up (T3).
RESULTS


Study procedures were modified according to focus group results. Enrollment, retention, and adherence were all ≥ 80%. Mixed-model ANOVAs demonstrated that the number of nighttime awakenings per actigraphy, and sleep quality and depression per self-report, trended toward improvements in the BL condition compared to the DL condition. These variables improved from T1 to T2 before returning to baseline at T3. Effect sizes were generally medium to large.
CONCLUSIONS


Study findings suggest that BL therapy is feasible among ovarian and endometrial cancer survivors. It may be an effective, non-pharmacological approach to reduce sleep disturbance and symptom burden in this population.",2020,"Emerging evidence suggests BL can improve sleep disturbance, symptom burden, and health-related quality of life in cancer and other populations; however, this research is limited.","['ovarian and endometrial cancer survivors', '18 ovarian or endometrial cancer survivors', 'Ovarian and Endometrial Cancer Survivors']","['Bright Light Intervention', '45\xa0min of BL or dim light (DL', 'BL therapy', 'Bright light (BL) therapy']","['Enrollment, retention, and adherence', 'sleep diaries and self-report questionnaires; and provided blood, saliva, and urine samples at baseline (T1), post-intervention (T2), and 3-month follow-up (T3', 'number of nighttime awakenings per actigraphy, and sleep quality and depression per self-report', 'sleep disturbance, symptom burden, and health-related quality of life']","[{'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0423899', 'cui_str': 'Gifted (observable entity)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005768'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.118184,"Emerging evidence suggests BL can improve sleep disturbance, symptom burden, and health-related quality of life in cancer and other populations; however, this research is limited.","[{'ForeName': 'Rina S', 'Initials': 'RS', 'LastName': 'Fox', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Sharon H', 'Initials': 'SH', 'LastName': 'Baik', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'McGinty', 'Affiliation': 'Department of Psychiatry and Behavioral Health, Ohio State University Wexner Medical Center, Columbus, OH, USA.'}, {'ForeName': 'Sofia F', 'Initials': 'SF', 'LastName': 'Garcia', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Reid', 'Affiliation': 'Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Bovbjerg', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Precilla', 'Initials': 'P', 'LastName': 'Fajardo', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Shahabi', 'Affiliation': 'Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Ong', 'Affiliation': 'Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Phyllis C', 'Initials': 'PC', 'LastName': 'Zee', 'Affiliation': 'Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Frank J', 'Initials': 'FJ', 'LastName': 'Penedo', 'Affiliation': 'Department of Psychology, University of Miami, 5665 Ponce de Leon Boulevard, Flipse Building, 5th Floor, Coral Gables, FL, 33146, USA. frank.penedo@miami.edu.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09861-0']
315,31235821,Tear film lipid layer increase after diquafosol instillation in dry eye patients with meibomian gland dysfunction: a randomized clinical study.,"Diquafosol promotes secretion of tear fluid and mucin at the ocular surface and is administered for treatment of dry eye (DE). Tear film lipid layer is secreted from meibomian glands and stabilizes the tear film. We recently showed that diquafosol administration increased lipid layer thickness (LLT) for up to 60 min in normal human eyes. We here evaluated tear film lipid layer in DE patients (n = 47) with meibomian gland dysfunction (MGD) before as well as 30, 60, and 90 min after diquafosol administration. One drop of artificial tears or one drop of diquafosol was applied randomly to the eyes of each patient. Diquafosol significantly increased LLT at 30 (P < 0.001) and 60 (P = 0.042) min and noninvasive tear film breakup time for at least 90 min (P < 0.001 at each assessment point). Artificial tears had no such effect. Diquafosol significantly improved the tear interferometric pattern compared with artificial tears (P < 0.001 at each assessment point). A single topical administration of diquafosol thus improved LLT and tear film stability in DE patients with MGD, suggesting that diquafosol is a potential treatment not only for aqueous-deficient DE but also for evaporative DE associated with MGD.",2019,Diquafosol significantly improved the tear interferometric pattern compared with artificial tears (P < 0.001 at each assessment point).,"['dry eye patients with meibomian gland dysfunction', 'DE patients (n\u2009=\u200947) with meibomian gland dysfunction (MGD) before as well as 30, 60, and 90\u2009min after diquafosol administration', 'DE patients with MGD']","['diquafosol', 'diquafosol instillation']","['Tear film lipid layer increase', 'LLT and tear film stability', 'lipid layer thickness (LLT', 'tear interferometric pattern', 'LLT']","[{'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1275684', 'cui_str': 'MGD-Meibomian gland dysfunction'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1955479', 'cui_str': ""diuridine 5'-(pentahydrogen tetraphosphate) tetrasodium salt""}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C1955479', 'cui_str': ""diuridine 5'-(pentahydrogen tetraphosphate) tetrasodium salt""}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",,0.0192245,Diquafosol significantly improved the tear interferometric pattern compared with artificial tears (P < 0.001 at each assessment point).,"[{'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Fukuoka', 'Affiliation': 'Omiya Hamada Eye Clinic, 1-169-1 Sakuragicho, Omiya-ku, Saitama, Saitama, 330-0854, Japan.'}, {'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Arita', 'Affiliation': 'Itoh Clinic, 626-11 Minami-Nakano, Minuma-ku, Saitama, Saitama, 337-0042, Japan. ritoh@za2.so-net.ne.jp.'}]",Scientific reports,['10.1038/s41598-019-45475-7']
316,31235748,Effects of Relaxing Music on Healthy Sleep.,"Sleep is vital for human health and wellbeing, and sleep disturbances are comorbid to many mental and physiological disorders. Music consistently improves subjective sleep quality, whereas results for objective sleep parameters diverge. These inconsistencies might be due to inter-individual differences. Here, 27 female subjects listened to either music or a control text before a 90 minutes nap in a within-subjects design. We show that music improved subjective sleep quality as compared to the text condition. In all participants, music resulted in a reduced amount of sleep stage N1 during the nap. In addition, music significantly increased the amount of slow-wave sleep (SWS) and increased the low/high frequency power ratio. However, these effects occurred only in participants with a low suggestibility index. We conclude that listening to music before a nap can improve subjective and objective sleep parameters in some participants.",2019,"In all participants, music resulted in a reduced amount of sleep stage N1 during the nap.","['27 female subjects', 'Healthy Sleep']","['Relaxing Music', 'listened to either music or a control text']","['subjective and objective sleep parameters', 'subjective sleep quality', 'amount of slow-wave sleep (SWS', 'sleep stage N1']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0542193', 'cui_str': 'Relaxed (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}]",27.0,0.0267106,"In all participants, music resulted in a reduced amount of sleep stage N1 during the nap.","[{'ForeName': 'Maren Jasmin', 'Initials': 'MJ', 'LastName': 'Cordi', 'Affiliation': 'University of Fribourg, Department of Psychology, Division of Cognitive Biopsychology and Methods, Fribourg, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Ackermann', 'Affiliation': 'University of Fribourg, Department of Psychology, Division of Cognitive Biopsychology and Methods, Fribourg, Switzerland.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Rasch', 'Affiliation': 'University of Fribourg, Department of Psychology, Division of Cognitive Biopsychology and Methods, Fribourg, Switzerland. bjoern.rasch@unifr.ch.'}]",Scientific reports,['10.1038/s41598-019-45608-y']
317,32270252,Treatments of osteoporosis increase bone material strength index in patients with low bone mass.,"Effects on bone material properties of two-year antiosteoporotic treatment were assessed using in vivo impact microindentation (IMI) in patients with low bone mineral density (BMD) values. Antiresorptive treatment, in contrast to vitamin D ± calcium treatment alone, induced BMD-independent increases in bone material strength index, measured by IMI, the magnitude of which depended on pretreatment values.
INTRODUCTION


Bone material strength index (BMSi), measured by IMI in vivo, is reduced in patients with fragility fractures, but there is no information about changes in values during long-term therapy. In the present study, we assessed changes in BMSi in patients receiving antiosteoporotic treatments for periods longer than 12 months.
METHODS


We included treatment-naive patients with low bone mass who had a BMSi measurement with OsteoProbe® at presentation and consented to a repeat measurement after treatment.
RESULTS


We studied 54 patients (34 women), median age 58 years, of whom 30 were treated with bisphosphonates or denosumab (treatment group) and 24 with vitamin D ± calcium alone (control group). There were no differences in clinical characteristics between the two groups with the exception of a higher number of previous fragility fractures in the treatment group. Baseline hip BMD and BMSi values were lower in the treatment group. After 23.1 ± 6.6 months, BMSi increased significantly in the treatment group (82.4 ± 4.3 vs 79.3 ± 4.1; p < 0.001), but did not change in the control group (81.5 ± 5.2 vs 82.2 ± 4.1; p = 0.35). Changes in BMSi with antiresorptives were inversely related with baseline values (r = - 0.43; p = 0.02) but not with changes in BMD. Two patients in the control group with large decreases in BMSi values sustained incident fractures.
CONCLUSION


In patients at increased fracture risk, antiresorptive treatments induced BMD-independent increases in BMSi values, the magnitude of which depended on pretreatment values.",2020,There were no differences in clinical characteristics between the two groups with the exception of a higher number of previous fragility fractures in the treatment group.,"['patients receiving antiosteoporotic treatments for periods longer than 12\xa0months', 'patients with fragility fractures', 'patients with low bone mass', 'treatment group) and 24 with', 'patients with low bone mineral density (BMD)\xa0values', 'naive patients with low bone mass who had a BMSi measurement with OsteoProbe® at presentation and consented to a repeat measurement after treatment', '54 patients (34 women), median age 58\xa0years, of whom 30 were treated with']","['vitamin D ± calcium alone (control group', 'bisphosphonates or denosumab']","['changes in BMSi', 'bone material properties', 'Baseline hip BMD and BMSi values', 'vivo impact microindentation (IMI', 'BMSi values', 'previous fragility fractures', 'BMSi', 'bone material strength index', 'osteoporosis increase bone material strength index', 'BMSi values sustained incident fractures']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4760971', 'cui_str': 'Fragility fracture'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C4760971', 'cui_str': 'Fragility fracture'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]",54.0,0.0374018,There were no differences in clinical characteristics between the two groups with the exception of a higher number of previous fragility fractures in the treatment group.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schoeb', 'Affiliation': 'Center for Bone Quality, Department of Medicine, Division Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Malgo', 'Affiliation': 'Center for Bone Quality, Department of Medicine, Division Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'J J M', 'Initials': 'JJM', 'LastName': 'Peeters', 'Affiliation': 'Center for Bone Quality, Department of Medicine, Division Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Winter', 'Affiliation': 'Center for Bone Quality, Department of Medicine, Division Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Papapoulos', 'Affiliation': 'Center for Bone Quality, Department of Medicine, Division Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Appelman-Dijkstra', 'Affiliation': 'Center for Bone Quality, Department of Medicine, Division Endocrinology, Leiden University Medical Center, Leiden, The Netherlands. n.m.appelman-dijkstra@lumc.nl.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-020-05375-3']
318,31910992,Long-Term Neurobehavioral and Quality of Life Outcomes of Critically Ill Children after Glycemic Control.,"OBJECTIVES


To investigate adaptive skills, behavior, and quality health-related quality of life in children from 32 centers enrolling in the Heart And Lung Failure-Pediatric INsulin Titration randomized controlled trial.
STUDY DESIGN


This prospective longitudinal cohort study compared the effect of 2 tight glycemic control ranges (lower target, 80-100 mg/dL vs higher target, 150-180 mg/dL) 1-year neurobehavioral and health-related quality of life outcomes. Subjects had confirmed hyperglycemia and cardiac and/or respiratory failure. Patients aged 2-16 years old enrolled between April 2012 and September 2016 were studied at 1 year after intensive care discharge. The primary outcome, adaptive skills, was assessed using the Vineland Adaptive Behavior Scale. Behavior and health-related quality of life outcomes were assessed as secondary outcomes using the Pediatric Quality of Life and Child Behavior Checklist at baseline and 1-year follow-up. Group differences were evaluated using regression models adjusting for age category, baseline overall performance, and risk of mortality.
RESULTS


Of 369 eligible children, 358 survived after hospital discharge and 214 (60%) completed follow-up. One-year Vineland Adaptive Behavior Scale-II composite scores were not different (mean ± SD, 79.9 ± 25.5 vs 79.4 ± 26.9, lower vs higher target; P = .20). Improvement in Pediatric Quality of Life total health from baseline was greater in the higher target group (adjusted mean difference, 8.2; 95% CI, 1.1-15.3; P = .02).
CONCLUSIONS


One-year adaptive behavior in critically ill children with lower vs higher target glycemic control did not differ. The higher target group demonstrated improvement from baseline in overall health. This study affirms the lack of benefit of lower glucose targeting.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01565941.",2020,"One-year Vineland Adaptive Behavior Scale-II composite scores were not different (mean ± SD, 79.9 ± ","['Subjects had confirmed hyperglycemia and cardiac and/or respiratory failure', 'Patients aged 2-16\xa0years old enrolled between April 2012 and September 2016 were studied at 1\xa0year after intensive care discharge', '369 eligible children, 358 survived after hospital discharge and 214 (60%) completed follow-up', 'children from 32 centers enrolling in the Heart And Lung Failure-Pediatric INsulin Titration randomized controlled trial', 'Critically Ill Children after Glycemic Control']",[],"['neurobehavioral and health-related quality of life outcomes', 'Behavior and health-related quality of life outcomes', 'adaptive skills', 'Vineland Adaptive Behavior Scale', 'adaptive skills, behavior, and quality health-related quality of life', 'overall performance, and risk of mortality', 'Pediatric Quality of Life and Child Behavior Checklist', 'One-year Vineland Adaptive Behavior Scale-II composite scores', 'Pediatric Quality of Life total health', 'overall health']","[{'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0085559'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales (assessment scale)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",369.0,0.429229,"One-year Vineland Adaptive Behavior Scale-II composite scores were not different (mean ± SD, 79.9 ± ","[{'ForeName': 'Katherine V', 'Initials': 'KV', 'LastName': 'Biagas', 'Affiliation': ""Department of Pediatrics, Stony Brook Children's Hospital and the Renaissance School of Medicine, Stony Brook, NY. Electronic address: katherine.biagas@stonybrookmedicine.edu.""}, {'ForeName': 'Veronica J', 'Initials': 'VJ', 'LastName': 'Hinton', 'Affiliation': 'Department of Psychology, Queens College and the Graduate Center of the City University of New York, New York, NY.'}, {'ForeName': 'Natalie R', 'Initials': 'NR', 'LastName': 'Hasbani', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Luckett', 'Affiliation': ""Department of Pediatrics, University of Texas Southwestern Medical Center and Children's Health, Dallas, TX.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wypij', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Vinay M', 'Initials': 'VM', 'LastName': 'Nadkarni', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia and the University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Michael S D', 'Initials': 'MSD', 'LastName': 'Agus', 'Affiliation': ""Division of Medical Critical Care, Department of Pediatrics, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.10.055']
319,31634023,Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma.,"Background:  Wixela ®  Inhub ®  is a dry powder inhaler approved as a generic equivalent to Advair ®  Diskus ®  (fluticasone propionate [FP]/salmeterol fixed-dose combination) for patients with asthma or chronic obstructive pulmonary disease (COPD). This study aimed at confirming the local (lung) therapeutic equivalence of both the FP and salmeterol components of Wixela Inhub (test [T]) to Advair Diskus (reference [R]) after inhalation.  Methods:  This randomized, double-blind, double-dummy, placebo-controlled, parallel-group study in patients ≥18 years with mild-to-moderate persistent asthma compared the local therapeutic equivalence (using forced expiratory volume in 1 second [FEV 1 ]) of FP/salmeterol (100/50 μg) after inhaled delivery via T and R.  Results:  Randomized patients ( N  = 1127) received T ( n  = 512), R ( n  = 512), or placebo ( n  = 103). T and R significantly increased day 1 FEV 1  area under the effect curve over 12 hours of the change from baseline (AUC [0-12] ) and day 29 trough FEV 1  over placebo, indicating that these endpoints were sufficiently sensitive for evaluation of bioequivalence. On day 1, T and R each increased FEV 1  AUC (0-12)  over placebo (3.134 L•h [T], 2.677 L•h [R]; each  p  < 0.0001). Following twice-daily dosing for 28 days, T and R also each increased trough FEV 1  (measured on day 29) over placebo (235 mL [T], 215 mL [R]; each  p  < 0.0001). Least-squares mean T/R ratios (90% confidence intervals) for day 1 FEV 1  AUC (0-12)  and day 29 trough FEV 1  were 1.120 (1.016-1.237) and 1.069 (0.938-1.220), respectively, indicating that T and R were bioequivalent for both co-primary endpoints. FP/salmeterol was well tolerated when administered via either T or R.  Conclusions:  These results demonstrate that the therapeutic effects of Wixela Inhub are bioequivalent to Advair Diskus in the lung. Wixela Inhub represents a therapeutically equivalent new FP/salmeterol treatment option for use in the treatment of asthma and COPD.",2020,T and R significantly increased day 1,"['patients ≥18 years with mild-to-moderate persistent asthma compared the local therapeutic equivalence (using forced expiratory volume in 1 second [FEV 1 ]) of', '100/50\u2009μg) after inhaled delivery via T and R.  Results:  Randomized patients ( N \u2009=\u20091127) received T ( n \u2009=\u2009512), R ( n \u2009=\u2009512), or', 'Adults With Asthma', 'patients with asthma or chronic obstructive pulmonary disease (COPD']","['Wixela Inhub and Advair Diskus', 'FP and salmeterol components of Wixela Inhub (test [T]) to Advair Diskus (reference [R', 'Advair ®  Diskus ®  (fluticasone propionate [FP]/salmeterol fixed-dose combination', 'placebo', 'FP/salmeterol']","['FEV 1  area under the effect curve', 'trough FEV 1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C0939246', 'cui_str': 'Advair Diskus'}, {'cui': 'C0073992', 'cui_str': 'salmeterol'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0965130', 'cui_str': 'Advair'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}]",1127.0,0.470131,T and R significantly increased day 1,"[{'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Ng', 'Affiliation': 'Mylan Pharma UK Ltd., Sandwich, Kent, United Kingdom.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Kerwin', 'Affiliation': 'Clinical Research Institute of Southern Oregon, Medford, Oregon.'}, {'ForeName': 'Martha V', 'Initials': 'MV', 'LastName': 'White', 'Affiliation': 'Institute for Asthma and Allergy, Wheaton, Maryland.'}, {'ForeName': 'S David', 'Initials': 'SD', 'LastName': 'Miller', 'Affiliation': 'Northeast Medical Research Associates, Inc., North Dartmouth, Massachusetts.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Haughie', 'Affiliation': 'Mylan Pharma UK Ltd., Sandwich, Kent, United Kingdom.'}, {'ForeName': 'Jonathan K', 'Initials': 'JK', 'LastName': 'Ward', 'Affiliation': 'Mylan Pharma UK Ltd., Sandwich, Kent, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Allan', 'Affiliation': 'Mylan Pharma UK Ltd., Sandwich, Kent, United Kingdom.'}]",Journal of aerosol medicine and pulmonary drug delivery,['10.1089/jamp.2019.1547']
320,31777203,A Thorough QT Study to Evaluate the Effects of a Supratherapeutic Dose of Sertraline on Cardiac Repolarization in Healthy Subjects.,"The effect of steady-state supratherapeutic sertraline (Zoloft) on QT interval was assessed in a single-center, randomized, 3-way crossover, double-blind, placebo- and moxifloxacin-controlled thorough QT study. Healthy adults received sertraline 400 mg/day, moxifloxacin 400 mg, and placebo, with a washout period (≥14 days) between treatments. A 12-lead electrocardiogram was recorded in triplicate before dosing and at selected time points up to 72 hours after dosing. Analysis of covariance using a mixed-effect model with sequence, period, treatment, time, and treatment-by-time interaction as fixed effects; subject within sequence as a random effect; and baseline QT corrected for heart rate using Fridericia formula (QTcF) as a covariate was conducted. A 90% confidence interval for the least squares (LS) mean difference in QTcF between active treatment and placebo was computed for each postdose time point. Exposure-response was assessed using linear mixed-effect modeling. Fifty-four subjects were enrolled. Over 24 hours after dosing, the LS mean difference in QTcF for sertraline versus placebo ranged from 5.597 milliseconds to 9.651 milliseconds. The upper bound of the 90% confidence interval for the LS mean difference exceeded a predefined 10-millisecond significance threshold at the 4-hour postdose time point only (LS mean, 9.651 milliseconds [90% confidence interval, 7.635-11.666]). In the exposure-response analysis, QTcF values increased significantly with increasing sertraline concentration (slope = 0.036 milliseconds/ng/mL; P < .0001). Predicted change from baseline in QTcF at therapeutic maximum plasma sertraline concentration was 3.57 milliseconds. This thorough QTc study demonstrated a positive signal for QTc prolongation for sertraline at the steady-state 400-mg/day dose.",2020,"In the exposure-response analysis, QTcF values increased significantly with increasing sertraline concentration (slope = 0.036 milliseconds/ng/mL; P < .0001).","['Healthy Subjects', 'Fifty-four subjects were enrolled', 'Healthy adults']","['steady-state supratherapeutic sertraline (Zoloft', 'Sertraline', 'sertraline 400\xa0mg/day, moxifloxacin 400\xa0mg, and placebo', 'placebo', 'placebo- and moxifloxacin']","['Exposure-response', 'QT interval', 'QTcF values', 'LS mean difference in QTcF', 'Cardiac Repolarization']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0284660', 'cui_str': 'Zoloft'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1592286', 'cui_str': 'moxifloxacin 400 MG [Avelox]'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",54.0,0.260677,"In the exposure-response analysis, QTcF values increased significantly with increasing sertraline concentration (slope = 0.036 milliseconds/ng/mL; P < .0001).","[{'ForeName': 'Richat', 'Initials': 'R', 'LastName': 'Abbas', 'Affiliation': 'Clinical Pharmacology, Pfizer Essential Health, Pfizer Inc, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Riley', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'LaBadie', 'Affiliation': 'Clinical Statistics, Pfizer Inc, New York, New York, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Bachinsky', 'Affiliation': 'CNS Clinical Affairs, Pfizer Essential Health, Pfizer Inc, New York, New York, USA.'}, {'ForeName': 'Phillip B', 'Initials': 'PB', 'LastName': 'Chappell', 'Affiliation': 'CNS Clinical Affairs, Pfizer Essential Health, Pfizer, Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Penelope H', 'Initials': 'PH', 'LastName': 'Crownover', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Bharat', 'Initials': 'B', 'LastName': 'Damle', 'Affiliation': 'Clinical Pharmacology, Pfizer Inc, New York, New York, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.749']
321,31729959,Pelvic floor muscle training in radical prostatectomy: a randomized controlled trial of the impacts on pelvic floor muscle function and urinary incontinence.,"BACKGROUND


Pelvic floor muscle training (PFM) training for post-prostatectomy incontinence (PPI) is an important rehabilitative approach, but the evidence base is still evolving. We developed a novel PFM training program focussed on activating fast and slow twitch muscle fibres. We hypothesized that this training, which commenced pre-operatively, would improve PFM function and reduce PPI, when compared to a control group.
METHODS


This randomized trial allocated 97 men (63 ± 7y, BMI = 25.4, Gleason 7) undergoing radical prostatectomy (RP) to either a control group (n = 47) performing low-volume rehabilitation, or an intervention group (n = 50). Both interventions commenced 5 weeks prior to surgery and continued for 12 weeks post-RP. Participants were assessed pre-operatively and at 2, 6 and 12 weeks post-RP using 24 h pad weights, International Prostate Symptom Score (IPSS), Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) and real time ultrasound (RTUS) measurements of PFM function.
RESULTS


Following RP, participants in the control group demonstrated a slower return to continence and experienced significantly more leakage (p < 0.05), measured by 24 h pad weight, compared to the intervention group, suggesting an impact of the prehabilitation protocol. PFM function measures were enhanced following RP in the intervention group. Secondary measures (IPSS, EPIC-CP and RTUS PFM function tests) demonstrated improvement across all time points, with the intervention group displaying consistently lower ""bothersome"" scores.
CONCLUSIONS


A pelvic floor muscle exercise program commenced prior to prostate surgery enhanced post-surgical measures of pelvic floor muscle function, reduced PPI and improved QoL outcomes related to incontinence.
TRIAL REGISTRATION


The trial was registered in the Australia New Zealand Clinical Trials Registry and allocated as ACTRN12617001400358. The trial was registered on 4/10/2017 and this was a retrospective registration.",2019,"Secondary measures (IPSS, EPIC-CP and RTUS PFM function tests) demonstrated improvement across all time points, with the intervention group displaying consistently lower ""bothersome"" scores.
","['radical prostatectomy', '97 men (63\u2009±\u20097y, BMI\u2009=\u200925.4, Gleason 7) undergoing', 'post-prostatectomy incontinence (PPI']","['PFM training program', 'radical prostatectomy (RP) to either a control group (n\u2009=\u200947) performing low-volume rehabilitation, or an intervention group', 'Pelvic floor muscle training', 'pelvic floor muscle exercise program', 'Pelvic floor muscle training (PFM) training']","['slower return to continence', 'PFM function and reduce PPI', 'PFM function measures', 'EPIC-CP) and real time ultrasound', 'leakage', 'Secondary measures (IPSS, EPIC-CP and RTUS PFM function tests', 'bothersome"" scores', 'pad weights, International Prostate Symptom Score (IPSS), Expanded Prostate Cancer Index Composite for Clinical Practice']","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",97.0,0.0588147,"Secondary measures (IPSS, EPIC-CP and RTUS PFM function tests) demonstrated improvement across all time points, with the intervention group displaying consistently lower ""bothersome"" scores.
","[{'ForeName': 'Joanne E', 'Initials': 'JE', 'LastName': 'Milios', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Western Australia, 6009, Australia. jomilios22@gmail.com.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Ackland', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Western Australia, 6009, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Crawley, Western Australia, 6009, Australia.'}]",BMC urology,['10.1186/s12894-019-0546-5']
322,31736082,Distinct trajectories of long-term symptom severity in pediatric obsessive-compulsive disorder during and after stepped-care treatment.,"BACKGROUND


First-line treatments for pediatric obsessive-compulsive disorder (OCD) include exposure-based cognitive-behavioral therapy (CBT) and selective serotonin reuptake inhibitors (SSRIs). No studies have thus far identified distinct classes and associated predictors of long-term symptom severity during and after treatment. Yet, these could form the basis for more personalized treatment in pediatric OCD.
METHOD


The study included 269 OCD patients aged 7-17 years from the Nordic Long-term OCD Treatment Study (NordLOTS). All participants received stepped-care treatment starting with 14 weekly sessions of manualized CBT. Nonresponders were randomized to either prolonged CBT or SSRIs. Symptom severity was assessed using the Children's Yale-Brown Obsessive-Compulsive Scale at seven time points from pre- to post-treatment and over a three-year follow-up. Latent class growth analysis (LCGA) was performed to identify latent classes of symptom severity trajectories. Univariate and multivariate analyses were used to detect differences between classes and identify predictors of trajectory class membership including several clinical and demographic variables.
TRIAL REGISTRY


Nordic Long-term Obsessive-Compulsive Disorder (OCD) Treatment Study; www.controlled-trials.com; ISRCTN66385119.
RESULTS


Three LCGA classes were identified: (a) acute, sustained responders (54.6%); (b) slow, continued responders (23.4%); and (c) limited long-term responders (21.9%). Class membership was predicted by distinct baseline characteristics pertaining to age, symptom severity, contamination/cleaning and anxiety symptoms.
CONCLUSIONS


The LCGA suggests three distinct trajectory classes of long-term symptom severity during and after treatment in pediatric OCD with different clinical profiles at pretreatment. The results point to required clinical attention for adolescent patients with contamination/cleaning and anxiety symptoms who do not show convincing responses to first-line treatment even though they may have reached the established cutoff for treatment response.",2020,"Class membership was predicted by distinct baseline characteristics pertaining to age, gender, symptom presentation, insight, avoidance, and comorbidity.
","['pediatric obsessive-compulsive disorder (OCD', 'pediatric obsessive-compulsive disorder during and after stepped-care treatment', 'adolescent patients with contamination/cleaning symptoms', '269 OCD patients aged 7-17\xa0years from the Nordic Long-term OCD Treatment Study (NordLOTS']","['cognitive-behavioral therapy (CBT) and selective serotonin reuptake inhibitors (SSRIs', 'stepped-care treatment starting with 14 weekly sessions of manualized CBT', 'prolonged CBT or SSRIs', 'LCGA']","[""Children's Yale-Brown Obsessive-Compulsive Scale"", 'Symptom severity']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]","[{'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}]",269.0,0.0154743,"Class membership was predicted by distinct baseline characteristics pertaining to age, gender, symptom presentation, insight, avoidance, and comorbidity.
","[{'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Jensen', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Psychiatry, Aarhus, Denmark.'}, {'ForeName': 'Davíð R M A', 'Initials': 'DRMA', 'LastName': 'Højgaard', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Psychiatry, Aarhus, Denmark.'}, {'ForeName': 'Katja A', 'Initials': 'KA', 'LastName': 'Hybel', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Psychiatry, Aarhus, Denmark.'}, {'ForeName': 'Erik Lykke', 'Initials': 'EL', 'LastName': 'Mortensen', 'Affiliation': 'Department of Public Health and Center for Healthy Aging, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gudmundur', 'Initials': 'G', 'LastName': 'Skarphedinsson', 'Affiliation': 'Faculty of Psychology, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Melin', 'Affiliation': 'Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Tord', 'Initials': 'T', 'LastName': 'Ivarsson', 'Affiliation': 'Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Judith Becker', 'Initials': 'JB', 'LastName': 'Nissen', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Psychiatry, Aarhus, Denmark.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Weidle', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare Central Norway, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Valderhaug', 'Affiliation': 'Regional Centre for Child and Youth Mental Health and Child Welfare Central Norway, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Nor Christian', 'Initials': 'NC', 'LastName': 'Torp', 'Affiliation': 'Division of Mental Health and Addiction, Department of Child and Adolescent Psychiatry, Vestre Viken Hospital, Drammen, Norway.'}, {'ForeName': 'Kitty', 'Initials': 'K', 'LastName': 'Dahl', 'Affiliation': 'Centre for Child and Adolescent Mental Health, Eastern and Southern Norway, Oslo, Norway.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Compton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Per Hove', 'Initials': 'PH', 'LastName': 'Thomsen', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Aarhus University Hospital, Psychiatry, Aarhus, Denmark.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13155']
323,31823525,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Non-Bile Acid FXR Agonist Tropifexor (LJN452) in Healthy Volunteers.","Tropifexor (LJN452) is a potent, orally available, non-bile acid farnesoid X receptor agonist under clinical development for chronic liver diseases. Here, we present results from a first-in-human study of tropifexor following single- and multiple-ascending doses (SAD/MAD) and food effect substudy in healthy volunteers. The SAD study included 6 fasted cohorts receiving 10- to 3000-µg tropifexor or placebo and 1 cohort receiving 300-µg tropifexor with a high-fat meal. The MAD study included 4 lean cohorts receiving 10 to 100 µg and 1 obese cohort receiving 30-µg once-daily doses or placebo for 14 days. Pharmacodynamic assessment of fibroblast growth factor 19 and fasting plasma lipids was performed after dosing. Overall, 95 volunteers received at least 1 tropifexor or placebo dose. Tropifexor was well tolerated up to 3000 µg and 100 µg in the SAD and MAD studies, respectively; however, 2 subjects discontinued the MAD study due to asymptomatic elevation of liver transaminases. At single doses, tropifexor showed a moderate rate of absorption (median time to maximum concentration, 4 hours), dose-proportional increases in exposure, and elimination half-life of 13.5 to 21.9 hours. When taken with food, tropifexor exposure increased by ∼60%. With multiple dosing, steady state was reached on day 4 with <2-fold accumulation. Single and multiple doses showed dose-dependent increases in fibroblast growth factor 19. No changes in serum lipids were observed in tropifexor- vs placebo-treated obese subjects. In conclusion, tropifexor was well tolerated, had a pharmacokinetic profile suitable for once-daily dosing and showed dose-dependent target engagement without altering plasma lipids in healthy volunteers.",2020,Single and multiple doses showed dose-dependent increases in fibroblast growth factor 19.,"['for 14 days', 'healthy volunteers', 'Healthy Volunteers', '4 lean cohorts receiving 10 to 100\xa0µg and 1 obese cohort receiving 30-µg once-daily doses or', '6 fasted cohorts receiving 10- to 3000-µg']","['tropifexor or placebo', 'Novel Non-Bile Acid FXR Agonist Tropifexor (LJN452', 'Tropifexor (LJN452', 'placebo', 'tropifexor or placebo and 1 cohort receiving 300-µg tropifexor with a high-fat meal', 'tropifexor', 'Tropifexor', 'tropifexor following single- and multiple-ascending doses (SAD/MAD']","['asymptomatic elevation of liver transaminases', 'serum lipids', 'Pharmacodynamic assessment of fibroblast growth factor 19 and fasting plasma lipids', 'fibroblast growth factor 19', 'moderate rate of absorption (median time to maximum concentration, 4\xa0hours), dose-proportional increases in exposure, and elimination half-life', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics', 'tolerated']","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0671759', 'cui_str': 'MAD'}]","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1292426', 'cui_str': '4 hours (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205351', 'cui_str': 'Proportional (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",95.0,0.124036,Single and multiple doses showed dose-dependent increases in fibroblast growth factor 19.,"[{'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Badman', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Novartis Institutes for BioMedical Research, East Hanover, New Jersey, USA.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Desai', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Soniya', 'Initials': 'S', 'LastName': 'Vaidya', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Neelakantham', 'Affiliation': 'Novartis Healthcare Pvt. Ltd., Hyderabad, India.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Gan', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Danis', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Laffitte', 'Affiliation': 'Genonics Institute of the Novartis Research Foundation, San Diego, California, USA.'}, {'ForeName': 'Lloyd B', 'Initials': 'LB', 'LastName': 'Klickstein', 'Affiliation': 'Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.762']
324,31610099,"Bioequivalence Study of 2 Formulations of Rivaroxaban, a Narrow-Therapeutic-Index Drug, in Healthy Chinese Subjects Under Fasting and Fed Conditions.","This study aimed to evaluate the bioequivalence (BE) of 2 formulations of the 10-mg rivaroxaban tablet. The study was a randomized, open-label, 4-period, crossover study that included 28 healthy subjects in fasting or fed conditions. The pharmacokinetic parameters were determined based on the concentrations of rivaroxaban using high-performance liquid chromatography with a tandem mass spectrometer detector. In each of the 4 study periods with fasting or fed conditions, a single dose of test or reference product was administered. Rivaroxaban concentrations in plasma were determined using a validated liquid chromatography with a tandem mass spectrometer detector method. The pharmacokinetic parameters assessed were the area under the plasma concentration-time curve (AUC 0-t  , AUC 0-∞  ), the peak plasma concentration of the drug (C max  ), time to achieve C max  , elimination half-life, within-subject variability of test drug, and within-subject variability of reference drug. The geometric mean ratio (90%CI) of the test drug/reference drug for rivaroxaban was 90.38% to 103.60% for AUC 0-t  in fasting conditions and 90.13% to 100.42% in fed conditions. The AUC 0-∞  s were 89.94% to 102.50% and 90.14% to 100.45% under fasting and fed conditions, respectively. The C max  values were 90.58% to 105.01% and 96.36% to 108.07% in these 2 conditions, respectively. All 90%CIs for test drug/reference drug geometric mean ratio were ≤2.5. The 90%CIs for test/reference AUC ratio and C max  ratio were within the acceptable range for BE. There were no adverse events encountered during this BE study. The study's results indicated that the 2 formulations of the rivaroxaban tablet were bioequivalent.",2020,"The AUC 0-∞  s were 89.94% to 102.50% and 90.14% to 100.45% under fasting and fed conditions, respectively.","['28 healthy subjects in fasting or fed conditions', 'Healthy Chinese Subjects Under Fasting and Fed Conditions']","['Rivaroxaban', 'rivaroxaban tablet', 'rivaroxaban']","['geometric mean ratio (90%CI', 'plasma concentration-time curve (AUC 0-t  , AUC 0-∞  ), the peak plasma concentration of the drug (C max  ), time to achieve C max  , elimination half-life', 'C max  values', 'reference AUC ratio and C max  ratio']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",28.0,0.0346383,"The AUC 0-∞  s were 89.94% to 102.50% and 90.14% to 100.45% under fasting and fed conditions, respectively.","[{'ForeName': 'Sijia', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Sufeng', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Pharmacy, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Hongwen', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Shao', 'Affiliation': 'Department of Phase I Clinical Trial Unit, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.742']
325,31793171,"Phase 1 Pharmacokinetic Study of AZD5718 in Healthy Volunteers: Effects of Coadministration With Rosuvastatin, Formulation and Food on Oral Bioavailability.","AZD5718 is a first-in-class small-molecule anti-inflammatory drug with the potential to reduce the residual risk of cardiovascular events after myocardial infarction in patients receiving lipid-lowering statin therapy. Leukotrienes are potent proinflammatory and vasoactive mediators synthesized in leukocytes via 5-lipoxygenase and 5-lipoxygenase-activating protein (FLAP). AZD5718 is a FLAP inhibitor that dose-dependently reduced leukotriene biosynthesis in a first-in-human study. We enrolled 12 healthy men in a randomized, open-label, crossover, single-dose phase 1 pharmacokinetic study of AZD5718 to investigate a potential drug-drug interaction with rosuvastatin, and the effects of formulation and food intake (ClinicalTrials.gov identifier: NCT02963116). Rosuvastatin (10 mg) were absorbed more rapidly when coadministered with AZD5718 (200 mg), probably owing to weak inhibition of hepatic statin uptake, but relative bioavailability was unaffected (geometric least-squares mean ratio [GMR], 100%; 90% confidence interval [CI], 86%-116%). AZD5718 pharmacokinetics were unaffected by coadministration of rosuvastatin. AZD5718 (200 mg) was absorbed less rapidly when formulated as tablets than oral suspension, with reduced relative bioavailability (GMR, 72%; 90%CI, 64%-80%). AZD5718 absorption was slower when 200-mg tablets were taken after a high-fat breakfast than after fasting, but relative bioavailability was unaffected (GMR, 96%; 90%CI, 87%-106%). In post hoc pharmacodynamic simulations, plasma leukotriene B 4  levels were inhibited by >90% throughout the day following once-daily AZD5718, regardless of formulation or administration with food. AZD5718 was well tolerated, with no severe or serious adverse events. These data supported the design of a phase 2a efficacy study of AZD5718 in patients with coronary artery disease.",2020,"In post hoc pharmacodynamic simulations, plasma leukotriene B 4  levels were inhibited by >90% throughout the day following once-daily AZD5718, regardless of formulation or administration with food.","['Healthy Volunteers', '12 healthy men', 'patients with coronary artery disease', 'patients receiving lipid-lowering statin therapy']","['AZD5718', 'Rosuvastatin', 'rosuvastatin', 'Rosuvastatin, Formulation and Food']","['leukotriene biosynthesis', 'Oral Bioavailability', 'plasma leukotriene B 4  levels', 'AZD5718 pharmacokinetics', 'relative bioavailability', 'tolerated, with no severe or serious adverse events', 'AZD5718 absorption']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C0023545', 'cui_str': 'Leukotrienes'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023546', 'cui_str': 'Leukotriene B-4'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}]",12.0,0.0255025,"In post hoc pharmacodynamic simulations, plasma leukotriene B 4  levels were inhibited by >90% throughout the day following once-daily AZD5718, regardless of formulation or administration with food.","[{'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Ericsson', 'Affiliation': 'Clinical Pharmacology, ADME and AI, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Nelander', 'Affiliation': 'Clinical Pharmacology, ADME and AI, Clinical Pharmacology & Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Heijer', 'Affiliation': 'Clinical Pharmacology Biologics and Bioanalysis, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Kjaer', 'Affiliation': 'Early Biometrics and Statistical Innovation, Data Science & AI, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Eva-Lotte', 'Initials': 'EL', 'LastName': 'Lindstedt', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal and Metabolic, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Muna', 'Initials': 'M', 'LastName': 'Albayaty', 'Affiliation': 'Parexel, Early Phase Clinical Unit, Harrow, UK.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Forte', 'Affiliation': 'Parexel, Early Phase Clinical Unit, Harrow, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lagerström-Fermér', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal and Metabolic, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Stanko', 'Initials': 'S', 'LastName': 'Skrtic', 'Affiliation': 'Research and Early Development, Cardiovascular, Renal and Metabolic, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.756']
326,31107360,Feasibility and Outcomes of the Early Start Denver Model Implemented with Low Intensity in a Community Setting in Austria.,"OBJECTIVE


To investigate the feasibility and effectiveness of early autism intervention with the Early Start Denver Model (ESDM) implemented with low intensity in a community service in Europe.
METHODS


Subjects were boys (n = 13, ages 34-54 months, mean age 43.3 months) consecutively diagnosed with autism spectrum disorder in a regional autism center in Austria. The subjects either received the ESDM intervention for 4.6 hours weekly over 12 months (n = 7) or intervention as usual (n = 6). Feasibility of the ESDM intervention was evaluated by parent and teacher questionnaires, ESDM fidelity measures, and therapists' feedback. Developmental status was assessed through standardized instruments (Mullen Scales of Early Learning [MSEL], Vineland Adaptive Behavior Scales Second Edition, Communicative Development Inventory, Pervasive Developmental Disorder Behavior Inventory [PDDBI], Parenting Sense of Competence Scale) at baseline and after intervention.
RESULTS


The ESDM intervention was delivered with high fidelity (>80%) by a newly trained multiprofessional team. Acceptability by parents was rated as high. The ESDM was considered to be compatible with both family and preschool routines without any major adaptations. The ESDM group showed a trend toward improved receptive language (MSEL receptive language; p = 0.09, effect size [ES] = 0.72) and reduction in parent-reported core autism symptoms (PDDBI Autism Composite Score; p = 0.04; ES = 0.95). No such improvement was noted in the control group.
CONCLUSION


Low-intensity implementation of the ESDM in a non-English-speaking community service context is feasible. Although outcomes from this small feasibility study should be interpreted with caution, our findings suggest a more favorable response to the ESDM intervention group compared with the control group.",2019,"The ESDM group showed a trend toward improved receptive language (MSEL receptive language; p = 0.09, effect size [ES] = 0.72) and reduction in parent-reported core autism symptoms (PDDBI Autism Composite Score; p = 0.04; ES = 0.95).","['community service in Europe', 'Subjects were boys (n = 13, ages 34-54 months, mean age 43.3 months) consecutively diagnosed with autism spectrum disorder in a regional autism center in Austria']","['ESDM intervention', 'early autism intervention with the Early Start Denver Model (ESDM', 'Early Start Denver Model']","[""parent and teacher questionnaires, ESDM fidelity measures, and therapists' feedback"", 'receptive language (MSEL receptive language', 'standardized instruments (Mullen Scales of Early Learning [MSEL], Vineland Adaptive Behavior Scales Second Edition, Communicative Development Inventory, Pervasive Developmental Disorder Behavior Inventory [PDDBI], Parenting Sense of Competence Scale']","[{'cui': 'C0009482', 'cui_str': 'Services, Community'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004348', 'cui_str': 'Austria'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0222045'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4273705', 'cui_str': 'Vineland Adaptive Behavior Scales Second Edition'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0524528', 'cui_str': 'Pervasive developmental disorder (disorder)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",,0.0453646,"The ESDM group showed a trend toward improved receptive language (MSEL receptive language; p = 0.09, effect size [ES] = 0.72) and reduction in parent-reported core autism symptoms (PDDBI Autism Composite Score; p = 0.04; ES = 0.95).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Holzinger', 'Affiliation': 'Hospital of St. John of God, Institute of Neurology of Senses and Language, Linz, Austria.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Laister', 'Affiliation': 'Hospital of St. John of God, Institute of Neurology of Senses and Language, Linz, Austria.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Vivanti', 'Affiliation': 'Early Detection & Intervention Program, AJ Drexel Autism Institute, Drexel University, Philadelphia, PA.'}, {'ForeName': 'William Joseph', 'Initials': 'WJ', 'LastName': 'Barbaresi', 'Affiliation': ""Division of Developmental Medicine, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Fellinger', 'Affiliation': 'Hospital of St. John of God, Institute of Neurology of Senses and Language, Linz, Austria.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000675']
327,32267624,Hysteropexy in the treatment of uterine prolapse stage 2 or higher: laparoscopic sacrohysteropexy versus sacrospinous hysteropexy-a multicentre randomised controlled trial (LAVA trial).,"OBJECTIVE


To investigate whether laparoscopic sacrohysteropexy (LSH) is non-inferior to vaginal sacrospinous hysteropexy (SSHP) in the surgical treatment of uterine prolapse.
DESIGN


Multicentre randomised controlled, non-blinded non-inferiority trial.
SETTING


Five non-university teaching hospitals in the Netherlands, one university hospital in Belgium.
POPULATION


126 women with uterine prolapse stage 2 or higher undergoing surgery without previous pelvic floor surgery.
METHODS


Randomisation in a 1:1 ratio to LSH or SSHP, stratified per centre and severity of the uterine prolapse. The predefined inferiority margin was an increase in surgical failure rate of 10%.
MAIN OUTCOME MEASURES


Primary outcome was surgical failure, defined as recurrence of uterine prolapse (POP-Q ≥ 2) with bothersome bulging/protrusion symptoms and/or repeat surgery or pessary at 12 months postoperatively. Secondary outcomes were anatomical recurrence (any compartment), functional outcome and quality of life.
RESULTS


Laparoscopic sacrohysteropexy was non-inferior for surgical failure (n = 1, 1.6%) compared with SSHP (n = 2, 3.3%, difference -1.7%, 95% CI: -7.1 to 3.7) 12 months postoperatively. Overall, anatomical recurrences and quality of life did not differ. More bothersome symptoms of overactive bladder (OAB) and faecal incontinence were reported after LSH. Dyspareunia was more frequently reported after SSHP.
CONCLUSION


Laparoscopic sacrohysteropexy was non-inferior to SSHP for surgical failure of the apical compartment at 12 months' follow up. Following LSH, bothersome OAB and faecal incontinence were more frequent, but dyspareunia was less frequent.
TWEETABLE ABSTRACT


Laparoscopic sacrohysteropexy and vaginal sacrospinous hysteropexy have equally good short-term outcomes.",2020,"CONCLUSION


LSH was non-inferior to SSHP for surgical failure of the apical compartment at 12 months' follow-up.","['uterine prolapse stage 2 or higher', 'Randomisation in a 1:1 ratio to LSH or SSHP, stratified per centre and severity of the uterine prolapse', '5 non-university teaching hospitals in the Netherlands, one university hospital in Belgium', '126 women with uterine prolapse stage 2 or higher undergoing surgery without previous pelvic floor surgery']","['LSH', 'Hysteropexy', 'laparoscopic sacrohysteropexy versus sacrospinous hysteropexy', 'laparoscopic sacrohysteropexy (LSH']","['surgical failure', 'dyspareunia', 'Overall anatomical recurrences and quality of life', 'anatomical recurrence (any compartment), functional outcome and quality of life', 'Dyspareunia', 'bothersome symptoms of overactive bladder (OAB) and faecal incontinence', 'bothersome OAB and faecal incontinence', 'surgical failure rate', 'surgical failure, defined as reoccurrence of uterine prolapse (POP-Q ≥ 2) with bothersome bulging/protrusion symptoms and/or repeat surgery or pessary at 12 months postoperative']","[{'cui': 'C0042140', 'cui_str': 'Uterine prolapse'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}]","[{'cui': 'C0195386', 'cui_str': 'Uteropexy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C3164185', 'cui_str': 'Sacrohysteropexy'}]","[{'cui': 'C1868733', 'cui_str': 'Surgical failure'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0042140', 'cui_str': 'Uterine prolapse'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",126.0,0.455185,"CONCLUSION


LSH was non-inferior to SSHP for surgical failure of the apical compartment at 12 months' follow-up.","[{'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'van IJsselmuiden', 'Affiliation': 'Department of Obstetrics and Gynaecology, Isala, Zwolle, The Netherlands.'}, {'ForeName': 'Amj', 'Initials': 'A', 'LastName': 'van Oudheusden', 'Affiliation': 'Department of Obstetrics and Gynaecology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Veen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'van de Pol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Gelre Ziekenhuizen, Apeldoorn, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vollebregt', 'Affiliation': 'Department of Obstetrics and Gynaecology, Spaarne Gasthuis, Hoofddorp, The Netherlands.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Radder', 'Affiliation': 'Department of Obstetrics and Gynaecology, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Housmans', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Smj', 'Initials': 'S', 'LastName': 'van Kuijk', 'Affiliation': 'Department of Obstetrics and Gynaecology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Deprest', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynaecology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Hwf', 'Initials': 'H', 'LastName': 'van Eijndhoven', 'Affiliation': 'Department of Obstetrics and Gynaecology, Isala, Zwolle, The Netherlands.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16242']
328,32267168,Self-guided mindfulness and cognitive behavioural practices reduce anxiety in autistic adults: A pilot 8-month waitlist-controlled trial of widely available online tools.,"LAY ABSTRACT


Anxiety in autism is an important target for psychological therapies because it is very common and because it significantly impacts upon quality of life and well-being. Growing evidence suggests that cognitive behaviour therapies and mindfulness-based therapies can help autistic individuals learn to manage feelings of anxiety but access to such therapies remains problematic. In the current pilot study, we examined whether existing online cognitive behaviour therapy and mindfulness-based therapy self-help tools can help reduce anxiety in autistic adults. Specifically, 35 autistic adults were asked to try either an existing online cognitive behaviour therapy (n = 16) or mindfulness-based therapy (n = 19) programme while a further 19 autistic adults served as a waitlist comparison group. A first important finding was that 23 of the 35 (66%) participants who tried the online tools completed them, suggesting that such tools are, in principle, acceptable to many autistic adults. In addition, adults in the cognitive behaviour therapy and mindfulness-based therapy conditions reported significant decreases in anxiety over 3 and to some extent also 6 months that were less apparent in the waitlist group of participants. On broader measures of mental health and well-being, the benefits of the online tools were less apparent. Overall, the results suggest that online self-help cognitive behaviour therapy and mindfulness-based therapy tools should be explored further as a means of providing cost-effective mental health support to at least those autistic individuals who can engage effectively with such online tools.",2020,"On broader measures of mental health and well-being, the benefits of the online tools were less apparent.","['35 autistic adults', '19 autistic adults served as a waitlist comparison group', 'autistic adults']","['Self-guided mindfulness and cognitive behavioural practices', 'existing online cognitive behaviour therapy and mindfulness-based therapy self-help tools', 'existing online cognitive behaviour therapy (n = 16) or mindfulness-based therapy']",['anxiety'],"[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",35.0,0.0145778,"On broader measures of mental health and well-being, the benefits of the online tools were less apparent.","[{'ForeName': 'Sebastian B', 'Initials': 'SB', 'LastName': 'Gaigg', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Flaxman', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Gracie', 'Initials': 'G', 'LastName': 'McLaven', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Ritika', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Dermot M', 'Initials': 'DM', 'LastName': 'Bowler', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'University of Westminster, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Roestorf', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Haenschel', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Jacqui', 'Initials': 'J', 'LastName': 'Rodgers', 'Affiliation': 'Newcastle University, UK.'}, {'ForeName': 'Mikle', 'Initials': 'M', 'LastName': 'South', 'Affiliation': 'Brigham Young University, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361320909184']
329,32267348,Short-term renal and metabolic effects of low dose vildagliptin treatment added-on insulin therapy in non-proteinuric patients with type 2 diabetes: open-label randomized prospective study.,"Objective The aim of this randomized comparative study was to assess renal and metabolic effects of vildagliptin in insulin-treated type 2 diabetes (T2DM) patients without overt chronic kidney disease. Subjects and methods We randomized 47 insulin-treated non-proteinuric patients with satisfactory controlled T2DM and estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m 2 either to continue insulin therapy (control) or to receive combined insulin-vildagliptin treatment (VIG group). We assessed eGFR using serum creatinine (eGFRcreat), cystatin C (eGFRcys), and both (eGFRcreat-cys), and urinary creatinine-adjusted excretion of albumin (UACR), type IV collagen (uCol IV/Cr), and neutrophil gelatinase-associated lipocalin (uNGAL/Cr) at baseline and after 6 months of treatment. Results Study groups were comparable in terms of age and sex (60.1 ± 6.1 years and 42.9% men in control group vs. 60.8 ± 5.2 years and 39.1% in VIG group). After 6 months of treatment, there were no significant changes in main assessed parameters in control group. VIG group demonstrated significant decrease in HbA1c, diastolic blood pressure, frequency of hypoglycemia, and high-sensitivity C-reactive protein level as compared to the changes in control group. While eGFRcreat, UACR, and uNGAL/Cr showed no significant changes after vildagliptin addition, eGFRcys, eGFRcreat-cys, and uCol IV/Cr changed significantly in comparison with control group (+7.0% [3.7;13.3]; +5.1% [1.4;8.5]; -32,8% [-55.8;-24.4], respectively, p < 0.01 each). Correlation and regression analysis revealed glucose-independent pattern of these changes. Conclusion Addition of vildagliptin to ongoing insulin therapy in patients with T2DM was associated with a reduction in uCol IV/Cr and an increase in eGFRcys and eGFRcreat-cys, independent of T2DM control parameters.",2020,"While eGFRcreat, UACR, and uNGAL/Cr showed no significant changes after vildagliptin addition, eGFRcys, eGFRcreat-cys, and uCol IV/Cr changed significantly in comparison with control group (+7.0% [3.7;13.3]; +5.1% [1.4;8.5]; -32,8% [-55.8;-24.4], respectively, p < 0.01 each).","['insulin-treated type 2 diabetes (T2DM) patients without overt chronic kidney disease', 'non-proteinuric patients with type 2 diabetes', 'We randomized 47 insulin-treated non-proteinuric patients with satisfactory controlled T2DM and estimated glomerular filtration rate (eGFR', 'patients with T2DM']","['vildagliptin', 'continue insulin therapy (control) or to receive combined insulin-vildagliptin treatment (VIG group']","['eGFR using serum creatinine (eGFRcreat), cystatin C (eGFRcys), and both (eGFRcreat-cys), and urinary creatinine-adjusted excretion of albumin (UACR), type IV collagen (uCol IV/Cr), and neutrophil gelatinase-associated lipocalin (uNGAL/Cr', 'vildagliptin addition, eGFRcys, eGFRcreat-cys, and uCol IV/Cr', 'HbA1c, diastolic blood pressure, frequency of hypoglycemia, and high-sensitivity C-reactive protein level', 'renal and metabolic effects']","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]","[{'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0301513', 'cui_str': 'Human vaccinia immune globulin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0009333', 'cui_str': 'Collagen type IV'}, {'cui': 'C0215955', 'cui_str': 'LCN2 protein, human'}, {'cui': 'C1570906', 'cui_str': 'vildagliptin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",47.0,0.0260822,"While eGFRcreat, UACR, and uNGAL/Cr showed no significant changes after vildagliptin addition, eGFRcys, eGFRcreat-cys, and uCol IV/Cr changed significantly in comparison with control group (+7.0% [3.7;13.3]; +5.1% [1.4;8.5]; -32,8% [-55.8;-24.4], respectively, p < 0.01 each).","[{'ForeName': 'Valentina K', 'Initials': 'VK', 'LastName': 'Bayrasheva', 'Affiliation': 'Institute of Endocrinology, Almazov National Medical Research Centre, Saint Petersburg, Russia.'}, {'ForeName': 'Ivan Y', 'Initials': 'IY', 'LastName': 'Pchelin', 'Affiliation': 'Department of Faculty Therapy, Saint Petersburg State University,, Saint Petersburg, Russia.'}, {'ForeName': 'Vladimir A', 'Initials': 'VA', 'LastName': 'Dobronravov', 'Affiliation': 'Research Institute of Nephrology, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russia.'}, {'ForeName': 'Alina Yu', 'Initials': 'AY', 'LastName': 'Babenko', 'Affiliation': 'Institute of Endocrinology, Almazov National Medical Research Centre, Saint Petersburg, Russia.'}, {'ForeName': 'Svetlana G', 'Initials': 'SG', 'LastName': 'Chefu', 'Affiliation': 'Experimental Research Laboratory, Laser Medicine Center, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russia.'}, {'ForeName': 'Ivan S', 'Initials': 'IS', 'LastName': 'Shatalov', 'Affiliation': 'Scientific and Research Institute of Bioengineering, Saint Petersburg National Research University of Information, Technologies, Mechanics and Optics, Saint Petersburg, Russia.'}, {'ForeName': 'Volha N', 'Initials': 'VN', 'LastName': 'Vasilkova', 'Affiliation': 'Department of Internal Medicine No.1 with the Course of Endocrinology, Gomel State Medical University, Gomel, Belarus.'}, {'ForeName': 'Natalia V', 'Initials': 'NV', 'LastName': 'Hudiakova', 'Affiliation': 'Department of Faculty Therapy, Saint Petersburg State University,, Saint Petersburg, Russia.'}, {'ForeName': 'Alexandra N', 'Initials': 'AN', 'LastName': 'Ivanova', 'Affiliation': 'Department of Faculty Therapy, Saint Petersburg State University,, Saint Petersburg, Russia.'}, {'ForeName': 'Pavel A', 'Initials': 'PA', 'LastName': 'Andoskin', 'Affiliation': 'Laboratory of Protein Biochemistry, State Research Institute of Highly Pure BioSubstances, Saint Petersburg, Russia.'}, {'ForeName': 'Elena N', 'Initials': 'EN', 'LastName': 'Grineva', 'Affiliation': 'Institute of Endocrinology, Almazov National Medical Research Centre, Saint Petersburg, Russia.'}]",Archives of endocrinology and metabolism,['10.20945/2359-3997000000220']
330,32253520,Home-based inspiratory muscle training in pediatric patients after kidney transplantation: a randomized clinical trial.,"BACKGROUND


Chronic kidney disease (CKD) represents the irreversible stages of renal failure and is a growing worldwide public health issue associated with increases in morbidity, mortality, and decreased quality of life. Kidney transplantation is considered one of the best treatment options in this population. However, even after surgery, respiratory muscle strength is below normal values, and inspiratory muscle training (IMT) improves respiratory muscle function, strength, and endurance. This study aimed to evaluate the effects of IMT regarding respiratory muscle strength, functional capacity, and pulmonary function in pediatric kidney transplant recipients with CKD, and secondarily, to assess the biochemical profile of patients after intervention.
METHODS


This is a randomized, double-blind, placebo-controlled trial. Patients were randomized into two groups, intervention (IG) and control (CG) and performed IMT home-based training for 6 weeks. In the IG, the load was adjusted to 40% of the maximal inspiratory pressure and in the CG was adjusted to a minimum placebo load (9 cm H 2 O).
RESULTS


Thirty-one patients were randomly allocated to the intervention (n = 16) or control (n = 15) groups. There were no differences at baseline between groups. Increase of 35% in the maximal inspiratory pressure predicted and 26% in the maximal expiratory pressure predicted in the IG were found, compared with 5 and 4% in the CG. There was an increase in hemoglobin and hematocrit values in the IG.
CONCLUSIONS


Home-based IMT provides a significant increase in respiratory muscle strength, without changes in functional capacity and pulmonary function. Benefits regarding biochemical markers (hemoglobin and hematocrit) were also observed.",2020,"There was an increase in hemoglobin and hematocrit values in the IG.
","['Thirty-one patients', 'Chronic kidney disease (CKD', 'pediatric kidney transplant recipients with CKD', 'pediatric patients after kidney transplantation']","['IMT', 'intervention (IG) and control (CG) and performed IMT home-based training for 6\xa0weeks', 'placebo', 'Home-based inspiratory muscle training']","['maximal expiratory pressure', 'respiratory muscle function, strength, and endurance', 'biochemical markers (hemoglobin and hematocrit', 'respiratory muscle strength', 'maximal inspiratory pressure', 'hemoglobin and hematocrit values', 'functional capacity and pulmonary function']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C4082175', 'cui_str': 'Maximum Expiratory Pressure'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",31.0,0.0551409,"There was an increase in hemoglobin and hematocrit values in the IG.
","[{'ForeName': 'Raquel P', 'Initials': 'RP', 'LastName': 'Carbonera', 'Affiliation': 'Graduate Program in Pediatrics, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Ana Paula O', 'Initials': 'APO', 'LastName': 'Barbosa', 'Affiliation': 'Academics in Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Tatiana C', 'Initials': 'TC', 'LastName': 'Normann', 'Affiliation': 'Academics in Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Pedro Dal', 'Initials': 'PD', 'LastName': 'Lago', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Clotilde D', 'Initials': 'CD', 'LastName': 'Garcia', 'Affiliation': 'Graduate Program in Pediatrics, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.'}, {'ForeName': 'Janice Luisa', 'Initials': 'JL', 'LastName': 'Lukrafka', 'Affiliation': 'Graduate Program in Pediatrics, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil. janicet@ufcspa.edu.br.'}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-020-04539-x']
331,31820593,Preemptive Anti-Stress Response Effects of Oxycodone Versus Sufentanil for Patients Undergoing Cardiac Valve Replacement-A Randomized Controlled Trial.,"Patients undergoing cardiac valve replacement may experience cardiovascular adverse events during the preoperative period before anesthesia. The study was to compare the preemptive anti-stress response effects of oxycodone versus sufentanil for patients undergoing cardiac valve replacement. Ninety-four patients were enrolled and assigned to group Oxy, group Suf and group NS. Patients in group Oxy were administrated with oxycodone 0.1 mg/kg, group Suf received sufentanil 0.1 μg/kg and group NS were given equivalent volume of normal saline. The primary outcomes included serum levels of cortisol, norepinephrine, and adrenaline. The secondary outcomes involved bispectral index value and the observer's assessment of awareness/sedation grade, levels of mean arterial pressure, heart rate, and the adverse reactions. Compared to group NS, the serum levels of cortisol at T 1  to T 5  (P < .05), and levels of norepinephrine and adrenaline at T 3  to T 5  (P < .05) in group Oxy and Suf were lower. The bispectral index value and observer's assessment of awareness/sedation grade T 1  to T 2  (P < .05) in group Suf were lower than those in group Oxy and NS. Compared with group NS, the levels of mean arterial pressure and heart rate in group Oxy and Suf at T 3  to T 5  (P < .05) were lower. The incidence of coughing was significantly higher in group Suf (23.3%), but not in group NS (6.7%), than that in group Oxy (3.3%). The preemptive analgesia of oxycodone may be used to inhibit the stress response, without leading to excessive sedation and respiratory depression, which may also help to stabilize hemodynamics during preoperative period.",2020,"Compared to group NS, the serum levels of cortisol at T 1  to T 5  (P < .05), and levels of norepinephrine and adrenaline at T 3  to T 5  (P < .05) in group Oxy and Suf were lower.","['Patients undergoing cardiac valve replacement may experience cardiovascular adverse events during the preoperative period before anesthesia', 'Patients', 'Ninety-four patients', 'patients undergoing cardiac valve replacement']","['Oxycodone Versus Sufentanil', 'oxycodone versus sufentanil', 'sufentanil 0.1\xa0μg/kg and group NS were given equivalent volume of normal saline', 'oxycodone']","[""bispectral index value and observer's assessment of awareness/sedation grade T 1  to T 2"", 'serum levels of cortisol', ""bispectral index value and the observer's assessment of awareness/sedation grade, levels of mean arterial pressure, heart rate, and the adverse reactions"", 'levels of mean arterial pressure and heart rate', 'incidence of coughing', 'serum levels of cortisol, norepinephrine, and adrenaline', 'levels of norepinephrine and adrenaline']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018826', 'cui_str': 'Cardiac Valves'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2712277', 'cui_str': 'Preoperative Period'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}]","[{'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]",94.0,0.0441799,"Compared to group NS, the serum levels of cortisol at T 1  to T 5  (P < .05), and levels of norepinephrine and adrenaline at T 3  to T 5  (P < .05) in group Oxy and Suf were lower.","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Sichuan Provincial Hospital for Women and Children/Affiliated Women and Children's Hospital of Chengdu Medical College, Chengdu, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Tu', 'Affiliation': 'Department of Anesthesiology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Gan', 'Affiliation': ""Department of Anesthesiology, Tangshan People's Hospital, Tangshan, China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Miao', 'Affiliation': ""Department of Anesthesiology, Wuxi People's Hospital, Nanjing Medical University, Wuxi, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesiology, the Third People's Hospital of Chengdu, Southwest Jiao Tong University, Chengdu, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, the Third People's Hospital of Chengdu, Southwest Jiao Tong University, Chengdu, China.""}, {'ForeName': 'Chuandong', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': ""Department of Anesthesiology, the Third People's Hospital of Chengdu, Southwest Jiao Tong University, Chengdu, China.""}]",Clinical pharmacology in drug development,['10.1002/cpdd.764']
332,32251792,The Efficacy and Safety of High-dose Daptomycin in the Treatment of Complicated Skin and Soft Tissue Infections in Asians.,"OBJECTIVE


To compare the efficacy and safety of standard-dose (SD) daptomycin with those of high-dose (HD) daptomycin in complicated skin and soft tissue infections (cSSTIs) in an Asian population.
MATERIALS AND METHODS


Patients from three medical centers diagnosed with cSSTIs were screened in the clinical information system. Patients included in the analysis were divided into two groups: those who received daptomycin at doses ≥ 6 mg/kg (HD group) and those receiving 4 mg/kg (SD group). The demographics and clinical treatment information were analyzed.
RESULTS


Overall, 155 patients were recruited, including 108 patients in the SD group and 47 patients in the HD group. The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005). Compared with the SD group, the HD group had statistically significant early clinical stabilization (72.34% vs 52.78%, P = 0.023). The results of the multivariate analysis indicated that HD daptomycin was an independent effector for early clinical stabilization (HR=0.394, P < 0.001). The rate of drug-related adverse events was equally distributed in the HD and SD groups (36.17% vs. 26.85%, P = 0.243).
CONCLUSION


Compared with SD daptomycin, HD daptomycin increased the rate of early clinical stabilization in Asian patients with cSSTIs, whereas the incidence of adverse events did not increase.",2020,"The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005).","['complicated skin and soft tissue infections (cSSTIs) in an Asian population', '155 patients were recruited, including 108 patients in the SD group and 47 patients in the HD group', 'Patients from three medical centers diagnosed with cSSTIs were screened in the clinical information system', 'Complicated Skin and Soft Tissue Infections in Asians']","['daptomycin at doses ≥ 6\u2009mg/kg (HD group) and those receiving 4\u2009mg/kg (SD group', 'High-dose Daptomycin', 'standard-dose (SD) daptomycin with those of high-dose (HD) daptomycin']","['clinical stabilization', 'rate of early clinical stabilization', 'incidence of adverse events', 'rate of drug-related adverse events', 'rate of healthcare-associated infections', 'efficacy and safety']","[{'cui': 'C4727978', 'cui_str': 'Complicated skin and soft tissue infection'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021428', 'cui_str': 'Information system'}]","[{'cui': 'C0057144', 'cui_str': 'Daptomycin'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",155.0,0.0449794,"The rate of healthcare-associated infections was higher in the HD group (61.70% vs. 37.04%), demonstrating a statistically significant difference (P = 0.005).","[{'ForeName': 'Xiao-Meng', 'Initials': 'XM', 'LastName': 'Dong', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Yong-Yuan', 'Initials': 'YY', 'LastName': 'Yao', 'Affiliation': ""Department of Intensive Care Medicine, Rizhao People's Hospital, Rizhao 276800, China.""}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Guan', 'Affiliation': ""Department of Infectious Diseases, Rizhao People's Hospital, Rizhao 276800, China.""}, {'ForeName': 'Qing-Yan', 'Initials': 'QY', 'LastName': 'Li', 'Affiliation': ""Department of Infectious Diseases, Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Feng-Zhe', 'Initials': 'FZ', 'LastName': 'Chen', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, Qilu Hospital of Shandong University, Jinan 250012, China. Electronic address: clinicalpaper@163.com.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.03.060']
333,32255205,Ultrasound-Guided Hydrodissection With Corticosteroid Injection in the Treatment of Carpal Tunnel Syndrome: A Pilot Study.,"OBJECTIVES


Corticosteroid injections can provide (temporary) relief in patients with mild to moderate carpal tunnel syndrome (CTS). Hydrodissection as part of an injection has been associated with positive clinical outcomes but data for CTS so far has been scarce. This study is designed to assess patient tolerance and secondarily provide pilot data on the added effect of hydrodissection.
METHODS


Twenty CTS patients were randomized to an ultrasound-guided betamethasone injection with hydrodissection (5 mL) or without (2 mL). Patient tolerance was assessed directly after intervention and patient-reported outcome after 4 and 24 weeks. Intra-group data were compared using Wilcoxon Signed Rank and inter-group with Wilcoxon rank-sum tests.
RESULTS


Tolerance and pain scores did not differ between the two groups. Symptom scores decreased in both groups, but to a lesser extent in the hydrodissection group with a mean difference of -0.8 versus -1.5 in the control group at 4 weeks (P = .02). At 6 months, this difference was no longer present (P = .81). No statistically significant differences were found between the hydrodissection and control groups in the function or pain scores at follow-up at either time point.
CONCLUSION


After injection, both symptomatic and functional scores improved, but the hydrodissected group did not show additional improvement. Data presented can be used to support larger studies to assess the value of hydrodissection in CTS management.",2020,"No statistically significant differences were found between the hydrodissection and control groups in the function or pain scores at follow-up at either time point.
","['patients with mild to moderate carpal tunnel syndrome (CTS', 'Carpal Tunnel Syndrome', 'Twenty CTS patients']","['ultrasound-guided betamethasone injection with hydrodissection', 'Ultrasound-Guided Hydrodissection With Corticosteroid Injection', 'Corticosteroid injections']","['symptomatic and functional scores', 'Patient tolerance', 'Symptom scores', 'function or pain scores', 'Tolerance and pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.075712,"No statistically significant differences were found between the hydrodissection and control groups in the function or pain scores at follow-up at either time point.
","[{'ForeName': 'Verena J M M', 'Initials': 'VJMM', 'LastName': 'Schrier', 'Affiliation': 'Departments of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Brault', 'Affiliation': 'Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Amadio', 'Affiliation': 'Departments of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota, USA.'}]",Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine,['10.1002/jum.15279']
334,32162808,"Prognostic and Predictive Value of Microsatellite Instability, Inflammatory Reaction and PD-L1 in Gastric Cancer Patients Treated with Either Adjuvant 5-FU/LV or Sequential FOLFIRI Followed by Cisplatin and Docetaxel: A Translational Analysis from the ITACA-S Trial.","BACKGROUND


Patients with high microsatellite instability (MSI) gastric cancer (GC) show improved survival and no benefit or harm from adjuvant and/or perioperative chemotherapy. The role of immune microenvironment in GC is largely unknown.
MATERIALS AND METHODS


In the present study, 256 tumor tissue blocks were centrally collected from patients enrolled in ITACA-S, a randomized adjuvant trial of 5-FU/LV versus sequential FOLFIRI and cisplatin-docetaxel. MSI status was assessed by multiplex PCR, inflammatory reaction by H&E morphological assessment, and programmed death-ligand 1 (PD-L1) expression by immunohistochemistry.
RESULTS


Overall, 9% patients had MSI-high tumors, 23% had high inflammatory reaction, 11% had tumor PD-L1 ≥ 1%, and 11% had stromal PD-L1 ≥ 1%. A significant association with disease-free survival (DFS) and overall survival (OS) was found for MSI-high (hazard ratio [HR], 0.43; p = .02; HR, 0.40; p = .02) and high inflammatory reaction (HR, 0.55; p = .010; HR, 0.53; p = .008) but not for PD-L1. At multivariable analysis, only MSI showed an independent association with both DFS (p = .02) and OS (p = .01), whereas inflammatory reaction showed an independent association only with OS (p = .04). Patients with tumor PD-L1 ≥ 1% had a significantly longer DFS in sequential chemotherapy than in than 5-FU/LV arm (interaction p = .04) and a trend for OS (interaction p = .12).
CONCLUSION


Our data suggest that MSI status could be a useful prognostic biomarker in patients with radically resected stage II-III GC and should be used as stratification factor in future trials. Tumor PD-L1 ≥ 1% should be further investigated as a potential predictor of benefit from intensive chemotherapy.
IMPLICATIONS FOR PRACTICE


In this post hoc analysis of patients with radically resected gastric cancer randomized to an intensive sequential chemotherapy regimen versus 5-FU/LV monotherapy as adjuvant treatment in the ITACA-S trial, MSI-high status was independently associated with better disease-free survival and overall survival (OS) and inflammatory reaction was independently associated with better OS. Moreover, tumor PD-L1 expression ≥1% was associated with greater benefit from intensive sequential chemotherapy compared with 5-fluorouracil plus leucovorin (5-FU/LV), whereas PD-L1 expression <1% was not, conditioning a statistically significant interaction between such biomarker and treatment arms. The meta-analysis of individual patients' data from available studies could yield data on the role of MSI status that could inform clinical decisions.",2020,"A significant association with disease-free survival (DFS) and overall survival (OS) was found for MSI-high (hazard ratio [HR], 0.43; p = .02; HR, 0.40; p = .02) and high inflammatory reaction (HR, 0.55; p = .010; HR, 0.53; p = .008) but not for PD-L1.","['256 tumor tissue blocks were centrally collected from patients enrolled in ITACA-S', 'patients with radically resected gastric cancer', 'Gastric Cancer Patients Treated with Either', 'Patients with high microsatellite instability (MSI) gastric cancer (GC']","['5-FU/LV versus sequential FOLFIRI and cisplatin-docetaxel', 'intensive sequential chemotherapy regimen versus 5-FU/LV monotherapy', '5-FU/LV', '5-fluorouracil plus leucovorin (5-FU/LV', 'Adjuvant 5-FU/LV or Sequential FOLFIRI Followed by Cisplatin and Docetaxel']","['multiplex PCR, inflammatory reaction by H&E morphological assessment, and programmed death-ligand 1 (PD-L1) expression by immunohistochemistry', 'DFS', 'disease-free survival (DFS) and overall survival (OS', 'high inflammatory reaction', 'MSI status', 'PD-L1 expression', 'inflammatory reaction', 'disease-free survival and overall survival (OS) and inflammatory reaction']","[{'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0920269', 'cui_str': 'Microsatellite Instability'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C3179032', 'cui_str': 'Multiplex PCR'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.129712,"A significant association with disease-free survival (DFS) and overall survival (OS) was found for MSI-high (hazard ratio [HR], 0.43; p = .02; HR, 0.40; p = .02) and high inflammatory reaction (HR, 0.55; p = .010; HR, 0.53; p = .008) but not for PD-L1.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Di Bartolomeo', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Morano', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Raimondi', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Miceli', 'Affiliation': 'Unit of Clinical Epidemiology and Trial Organization, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Corallo', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Tamborini', 'Affiliation': 'Pathology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Perrone', 'Affiliation': 'Pathology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Antista', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Niger', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Pellegrinelli', 'Affiliation': 'Pathology Department, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Randon', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pagani', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Martinetti', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Fucà', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Pietrantonio', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The oncologist,['10.1634/theoncologist.2019-0471']
335,32162813,Phase IIIb Safety and Efficacy of Intravenous NEPA for Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients with Breast Cancer Receiving Initial and Repeat Cycles of Anthracycline and Cyclophosphamide (AC) Chemotherapy.,"BACKGROUND


NEPA, a combination antiemetic of a neurokinin-1 (NK 1  ) receptor antagonist (RA) (netupitant [oral]/fosnetupitant [intravenous; IV]) and 5-HT 3  RA, palonosetron] offers 5-day CINV prevention with a single dose. Fosnetupitant solution contains no allergenic excipients, surfactant, emulsifier, or solubility enhancer. A phase III study of patients receiving cisplatin found no infusion-site or anaphylactic reactions related to IV NEPA. However, hypersensitivity reactions and anaphylaxis have been reported with other IV NK 1  RAs, particularly fosaprepitant in patients receiving anthracycline-cyclophosphamide (AC)-based chemotherapy. This study evaluated the safety and efficacy of IV NEPA in the AC setting.
MATERIALS AND METHODS


This phase IIIb, multinational, randomized, double-blind study enrolled females with breast cancer naive to highly or moderately emetogenic chemotherapy. Patients were randomized to receive a single 30-minute infusion of IV NEPA or single oral NEPA capsule on day 1 prior to AC, in repeated (up to 4) cycles. Oral dexamethasone was given to all patients on day 1 only.
RESULTS


A total of 402 patients were included. The adverse event (AE) profiles were similar for IV and oral NEPA and consistent with those expected. Most AEs were mild or moderate with a similarly low incidence of treatment-related AEs in both groups. There were no treatment-related injection-site AEs and no reports of hypersensitivity or anaphylaxis. The efficacy of IV and oral NEPA were similar, with high complete response (no emesis/no rescue) rates observed in cycle 1 (overall [0-120 hours] 73.0% IV NEPA, 77.3% oral NEPA) and maintained over subsequent cycles.
CONCLUSION


IV NEPA was highly effective and safe with no associated hypersensitivity and injection-site reactions in patients receiving AC.
IMPLICATIONS FOR PRACTICE


As a combination of a neurokinin-1 (NK 1  ) receptor antagonist (RA) and 5-HT 3  RA, NEPA offers 5-day chemotherapy-induced nausea and vomiting prevention with a single dose and an opportunity to improve adherence to antiemetic guidelines. In this randomized multinational phase IIIb study, intravenous (IV) NEPA (fosnetupitant/palonosetron) was safe and highly effective in patients receiving multiple cycles of anthracycline-cyclophosphamide (AC)-based chemotherapy. Unlike other IV NK 1  RAs, the IV NEPA combination solution does not require any surfactant, emulsifier, or solubility enhancer and contains no allergenic excipients. Hypersensitivity reactions and anaphylaxis have been reported with other IV NK 1  RAs, most commonly with fosaprepitant in the AC setting. Importantly, there were no injection-site or hypersensitivity reactions associated with IV NEPA.",2020,"CONCLUSION


IV NEPA was highly effective and safe with no associated hypersensitivity and injection-site reactions in patients receiving AC.
","['patients receiving AC', 'patients receiving multiple cycles of', 'enrolled females with breast cancer naive to highly or moderately emetogenic chemotherapy', 'Patients with Breast Cancer', 'A total of 402 patients were included']","['Oral dexamethasone', 'IV and oral NEPA', 'neurokinin-1 (NK 1  ) receptor antagonist (RA) and 5-HT 3  RA, NEPA', 'neurokinin-1 (NK 1  ) receptor antagonist (RA) (netupitant [oral]/fosnetupitant [intravenous; IV]) and 5-HT 3  RA, palonosetron', 'Anthracycline and Cyclophosphamide', 'IV NEPA', 'intravenous (IV) NEPA (fosnetupitant/palonosetron', 'Intravenous NEPA', 'cisplatin', 'IV NEPA or single oral NEPA capsule', 'anthracycline-cyclophosphamide (AC)-based chemotherapy']","['adverse event (AE) profiles', 'hypersensitivity and injection-site reactions', 'injection-site or hypersensitivity reactions', 'Nausea and Vomiting (CINV', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C1700730', 'cui_str': 'netupitant'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C4691680', 'cui_str': 'fosnetupitant'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}, {'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}, {'cui': 'C0020517', 'cui_str': 'Allergy'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",402.0,0.0576046,"CONCLUSION


IV NEPA was highly effective and safe with no associated hypersensitivity and injection-site reactions in patients receiving AC.
","[{'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Schwartzberg', 'Affiliation': 'Hematology & Oncology, West Cancer Center, Germantown, Tennessee, USA.'}, {'ForeName': 'Rudolph', 'Initials': 'R', 'LastName': 'Navari', 'Affiliation': 'Department of Hematology/Oncology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Clark-Snow', 'Affiliation': 'Overland Park, Kansas, USA.'}, {'ForeName': 'Ekaterine', 'Initials': 'E', 'LastName': 'Arkania', 'Affiliation': 'The Institute of Clinical Oncology, Tbilisi, Georgia.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Radyukova', 'Affiliation': 'Department of Chemotherapy, Clinical Oncology Center, Omsk, Russia.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'CARTI Cancer Center, Little Rock, Arkansas, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Voisin', 'Affiliation': 'Helsinn Healthcare, Lugano, Switzerland.'}, {'ForeName': 'Giada', 'Initials': 'G', 'LastName': 'Rizzi', 'Affiliation': 'Helsinn Healthcare, Lugano, Switzerland.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Wickham', 'Affiliation': 'Rapid River, Michigan, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Gralla', 'Affiliation': 'Department of Medical Oncology, Albert Einstein College of Medicine, Bronx, New York, USA.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Aapro', 'Affiliation': 'Cancer Centre, Clinique de Genolier, Genolier, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Roeland', 'Affiliation': 'Oncology & Palliative Care, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0527']
336,32162816,Olanzapine Versus Haloperidol for Treatment of Delirium in Patients with Advanced Cancer: A Phase III Randomized Clinical Trial.,"BACKGROUND


Treatment of delirium often includes haloperidol. Second-generation antipsychotics like olanzapine have emerged as an alternative with possibly fewer side effects. The aim of this multicenter, phase III, randomized clinical trial was to compare the efficacy and tolerability of olanzapine with haloperidol for the treatment of delirium in hospitalized patients with advanced cancer.
MATERIALS AND METHODS


Eligible adult patients (≥18 years) with advanced cancer and delirium (Delirium Rating Scale-Revised-98 [DRS-R-98] total score ≥17.75) were randomized 1:1 to receive either haloperidol or olanzapine (age-adjusted, titratable doses). Primary endpoint was delirium response rate (DRR), defined as number of patients with DRS-R-98 severity score <15.25 and ≥4.5 points reduction. Secondary endpoints included time to response (TTR), tolerability, and delirium-related distress.
RESULTS


Between January 2011 and June 2016, 98 patients were included in the intention-to-treat analysis. DRR was 45% (95% confidence interval [CI], 31-59) for olanzapine and 57% (95% CI, 43-71) for haloperidol (Δ DRR -12%; odds ratio [OR], 0.61; 95% CI, 0.2-1.4; p = .23). Mean TTR was 4.5 days (95% CI, 3.2-5.9 days) for olanzapine and 2.8 days (95% CI, 1.9-3.7 days; p = .18) for haloperidol. Grade ≥3 treatment-related adverse events occurred in 5 patients (10.2%) and 10 patients (20.4%) in the olanzapine and haloperidol arm, respectively. Distress rates were similar in both groups. The study was terminated early because of futility.
CONCLUSION


Delirium treatment with olanzapine in hospitalized patients with advanced cancer did not result in improvement of DRR or TTR compared with haloperidol. Clinical trial identification number. NCT01539733. Dutch Trial Register. NTR2559.
IMPLICATIONS FOR PRACTICE


Guidelines recommend that pharmacological interventions for delirium treatment in adults with cancer should be limited to patients who have distressing delirium symptoms. It was suggested that atypical antipsychotics, such as olanzapine, outperform haloperidol in efficacy and safety. However, collective data comparing the efficacy and safety of typical versus atypical antipsychotics in patients with cancer are limited. If targeted and judicious use of antipsychotics is considered for the treatment of delirium in patients with advanced cancer, this study demonstrated that there was no statistically significant difference in response to haloperidol or olanzapine. Olanzapine showed an overall better safety profile compared with haloperidol, although this difference was not statistically significant.",2020,"Olanzapine showed an overall better safety profile compared with haloperidol, although this difference was not statistically significant.","['Eligible adult patients (≥18\u2009years) with advanced cancer and delirium (Delirium Rating Scale-Revised-98', 'Patients with Advanced Cancer', 'hospitalized patients with advanced cancer', 'patients with advanced cancer', 'patients with cancer', 'Between January 2011 and June 2016, 98 patients were included in the intention-to-treat analysis', 'adults with cancer']","['haloperidol', 'Olanzapine', 'haloperidol or olanzapine', 'Olanzapine Versus Haloperidol', 'olanzapine with haloperidol', 'olanzapine']","['efficacy and tolerability', 'Mean TTR', 'overall better safety profile', 'efficacy and safety', 'time to response (TTR), tolerability, and delirium-related distress', 'DRR or TTR', 'Distress rates', 'delirium response rate (DRR), defined as number of patients with DRS-R-98 severity score', 'Grade ≥3 treatment-related adverse events', 'DRR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0222045'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",98.0,0.161751,"Olanzapine showed an overall better safety profile compared with haloperidol, although this difference was not statistically significant.","[{'ForeName': 'Maurice J D L', 'Initials': 'MJDL', 'LastName': 'van der Vorst', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Elisabeth C W', 'Initials': 'ECW', 'LastName': 'Neefjes', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Manon S A', 'Initials': 'MSA', 'LastName': 'Boddaert', 'Affiliation': 'Netherlands Comprehensive Cancer Organisation (IKNL), Utrecht, The Netherlands.'}, {'ForeName': 'Bea A T T', 'Initials': 'BATT', 'LastName': 'Verdegaal', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Aart', 'Initials': 'A', 'LastName': 'Beeker', 'Affiliation': 'Department of Internal Medicine, Spaarne Gasthuis, Hoofddorp, The Netherlands.'}, {'ForeName': 'Saskia C C', 'Initials': 'SCC', 'LastName': 'Teunissen', 'Affiliation': 'Department of General Practice, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Aartjan T F', 'Initials': 'ATF', 'LastName': 'Beekman', 'Affiliation': 'Department of Psychiatry, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Janneke A', 'Initials': 'JA', 'LastName': 'Wilschut', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Berkhof', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Wouter W A', 'Initials': 'WWA', 'LastName': 'Zuurmond', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk M W', 'Initials': 'HMW', 'LastName': 'Verheul', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",The oncologist,['10.1634/theoncologist.2019-0470']
337,32162821,Premature Termination of a Randomized Controlled Trial on Image-Guided Stereotactic Body Radiotherapy of Metastatic Spinal Cord Compression.,"LESSONS LEARNED


It is possible to plan and treat some patients with stereotactic body radiotherapy (SBRT) in a timely fashion in an acute setting. Advanced and, in some indications, already implemented technologies such as SBRT are difficult to test in a randomized trial.
BACKGROUND


Stereotactic body radiotherapy (SBRT) in metastatic spinal cord compression (MSCC) could be an alternative to decompressive surgery followed by fractionated radiotherapy.
METHODS


In a randomized, single-institution, noninferiority trial, patients with MSCC were assigned to stereotactic body radiotherapy of 16 Gy in 1 fraction or decompression surgery followed by fractionated radiotherapy of 30 Gy in 10 fractions. Primary endpoint was ability to walk by EQ5D-5L questionnaire. Based on power calculations, 130 patients had to be included to be 89% sure that a 15% difference between the treatment arm and the experimental arm could be detected.
RESULTS


Ten patients were accrued in 23 months, with six patients allocated to surgery and four patients to stereotactic body radiotherapy. The trial was closed prematurely because of poor accrual. One patient undergoing surgery and one patient undergoing stereotactic body radiotherapy were unable to walk at 6 weeks. Two patients were not evaluable at 6 weeks.
CONCLUSION


A randomized, phase II, clinical trial comparing surgery followed by fractionated radiotherapy or image-guided SBRT of MSCC was initiated. SBRT was shown to be feasible, with three out of four patients retaining walking function. The trial was determined futile as a result of low accrual.",2020,"SBRT was shown to be feasible, with three out of four patients retaining walking function.","['Metastatic Spinal Cord Compression', 'patients with MSCC', 'metastatic spinal cord compression (MSCC']","['stereotactic body radiotherapy', 'Stereotactic body radiotherapy (SBRT', 'SBRT', 'stereotactic body radiotherapy of 16 Gy in 1 fraction or decompression surgery followed by fractionated radiotherapy', 'Image-Guided Stereotactic Body Radiotherapy', 'stereotactic body radiotherapy (SBRT', 'fractionated radiotherapy']",['ability to walk by EQ5D-5L questionnaire'],"[{'cui': 'C4076184', 'cui_str': 'Spinal cord compression due to metastasis to spine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1829459', 'cui_str': 'Decompression (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",2.0,0.139858,"SBRT was shown to be feasible, with three out of four patients retaining walking function.","[{'ForeName': 'Morten Hiul', 'Initials': 'MH', 'LastName': 'Suppli', 'Affiliation': 'Department of Oncology, Section of Radiotherapy, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Munck Af Rosenschold', 'Affiliation': 'Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Benny', 'Initials': 'B', 'LastName': 'Dahl', 'Affiliation': 'Spine Unit, Department of Orthopaedic Surgery, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne Kiil', 'Initials': 'AK', 'LastName': 'Berthelsen', 'Affiliation': 'Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Svend Aage', 'Initials': 'SA', 'LastName': 'Engelholm', 'Affiliation': 'Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Pappot', 'Affiliation': 'Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}]",The oncologist,['10.1634/theoncologist.2019-0672']
338,31454829,Acute kidney injury risk-based screening in pediatric inpatients: a pragmatic randomized trial.,"BACKGROUND


Pediatric acute kidney injury (AKI) is common and associated with increased morbidity, mortality, and length of stay. We performed a pragmatic randomized trial testing the hypothesis that AKI risk alerts increase AKI screening.
METHODS


All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included. The intervention alert displayed if calculated AKI risk was > 50% and no serum creatinine (SCr) was ordered within 24 h. The primary outcome was SCr testing within 48 h of AKI risk > 50%.
RESULTS


Among intensive care admissions, 973/1909 (51%) were randomized to the intervention. Among those at risk, more SCr tests were ordered for the intervention group than for controls (418/606, 69% vs. 361/597, 60%, p = 0.002). AKI incidence and severity were the same in intervention and control groups. Among ward admissions, 5492/10997 (50%) were randomized to the intervention, and there were no differences between groups in SCr testing, AKI incidence, or severity of AKI.
CONCLUSIONS


Alerts based on real-time prediction of AKI risk increased screening rates in intensive care but not pediatric ward settings. Pragmatic clinical trials provide the opportunity to assess clinical decision support and potentially eliminate ineffective alerts.",2020,AKI incidence and severity were the same in intervention and control groups.,"['pediatric inpatients', 'All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included']",[],"['serum creatinine (SCr', 'SCr tests', 'AKI incidence and severity', 'morbidity, mortality, and length of stay', 'SCr testing within 48\u2009h of AKI risk', 'SCr testing, AKI incidence, or severity of AKI', 'calculated AKI risk']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0085559'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.192399,AKI incidence and severity were the same in intervention and control groups.,"[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA. sara.van.driest@vumc.org.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'McLemore', 'Affiliation': 'Health Information Technology, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Bridges', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Fleming', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'McGregor', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Jones', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Shirey-Rice', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Gatto', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Gay', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Bernard', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}]",Pediatric research,['10.1038/s41390-019-0550-1']
339,31464087,"A 3-Part Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DSP-6952 in Healthy Japanese Subjects and Those With ≤3 Spontaneous Bowel Movements per Week.","We hypothesized that DSP-6952, a partial agonist of the 5-hydroxytryptamine type-4 receptor and a gastrointestinal prokinetic agent, can induce natural bowel movements by enhancing gastrointestinal motility and colonic transit in patients with chronic constipation and irritable bowel syndrome with constipation. This 3-part phase 1 study evaluated the safety, tolerability, and pharmacokinetic and pharmacodynamic profiles of DSP-6952. Eighty-eight Japanese subjects (64 healthy volunteers and 24 subjects with spontaneous bowel movements ≤3 times/wk) were randomized to DSP-6952 or placebo. The overall incidence of treatment-emergent adverse events (TEAEs) was similar for DSP-6952 and placebo. The most frequent TEAEs were gastrointestinal disorders; diarrhea was more common with DSP-6952, but only when it was administered to healthy volunteers. Peak plasma concentration (C max  ) and area under the concentration-time curve (AUC) of DSP-6952 were dose-proportional within a range of 4-120 mg. Under fed conditions, the C max  and AUC of DSP-6952 were approximately half those of fasting conditions. No abnormal drug accumulation was observed with repeated administration. In subjects with spontaneous bowel movements ≤3 times/wk, the median change in the frequency of bowel movements from baseline increased, although the difference did not reach statistical significance. DSP-6952 was well tolerated at single and multiple doses up to 120 mg/d, with a linear pharmacokinetic profile among all subjects.",2020,The overall incidence of treatment-emergent adverse events (TEAEs) was similar for DSP-6952 and placebo.,"['Healthy Japanese Subjects and Those With ≤3 Spontaneous Bowel Movements per Week', 'patients with chronic constipation and irritable bowel syndrome with constipation', 'Eighty-eight Japanese subjects (64 healthy volunteers and 24 subjects with spontaneous bowel movements ≤3 times/wk']","['DSP-6952 or placebo', 'DSP-6952']","['Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics', 'safety, tolerability, and pharmacokinetic and pharmacodynamic profiles of DSP-6952', 'gastrointestinal disorders; diarrhea', 'frequency of bowel movements', 'C max  and AUC of DSP-6952', 'overall incidence of treatment-emergent adverse events (TEAEs', 'abnormal drug accumulation', 'Peak plasma concentration (C max  ) and area under the concentration-time curve (AUC) of DSP-6952']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0401149', 'cui_str': 'Chronic constipation (disorder)'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action (observable entity)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",88.0,0.0401225,The overall incidence of treatment-emergent adverse events (TEAEs) was similar for DSP-6952 and placebo.,"[{'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Yumizaki', 'Affiliation': 'Clinical Pharmacology Group, Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Osaka, Japan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Maeda', 'Affiliation': 'Department of Pharmacy, Kitasato University Hospital, Kitasato University Graduate School of Medical Science, Kanagawa, Japan.'}, {'ForeName': 'Tomoe', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of Pharmacology and Toxicology, Dokkyo Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Kakuyama', 'Affiliation': 'Clinical Pharmacology Group, Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Kumagai', 'Affiliation': 'Kitasato Clinical Research Center, Kitasato University School of Medicine, Kanagawa, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.731']
340,31273507,Relationship between circadian activity rhythms and fatigue in hospitalized children with CNS cancers receiving high-dose chemotherapy.,"PURPOSE


Robust circadian rhythms are increasingly recognized as essential to good health. Adult cancer patients with dysregulated circadian activity rhythms (CAR) experience greater fatigue, lower responsiveness to chemotherapy, and shorter time to relapse. There is scant research describing circadian rhythms and associated outcomes in children with cancer. As part of a larger study examining whether a cognitive-behavioral intervention could preserve sleep in children and adolescents with central nervous system cancers hospitalized for high-dose chemotherapy (HDCT), this study aimed to compare CAR of these children to published values and to investigate the relationship between CAR and fatigue.
METHODS


Participants aged 4-19 years wore an actigraph throughout their hospitalization (5 days). From activity counts recorded by actigraphy, six CAR variables were calculated: amplitude, 24-h autocorrelation (r24), dichotomy index (I < O), interdaily stability (IS), intradaily variability (IV), and acrophase. Parent-reported child fatigue and child/adolescent self-reported fatigue measures were collected daily.
RESULTS


Thirty-three participants were included. Three CAR variables (amplitude, r24, and I < O) showed dysregulation compared to published values. Older age was significantly associated with later acrophase and greater dysregulation of all other CAR variables. Controlling for age, more dysregulated amplitude (p = 0.001), r24 (p = 0.003), IS (p = 0.017), and IV (p = 0.001) were associated with higher parent-reported fatigue; more dysregulated IV (p = 0.003) was associated with higher child-reported fatigue.
CONCLUSIONS


Participants demonstrated dysregulated CAR during hospitalization for HDCT. Greater dysregulation was associated with greater fatigue. Research on circadian dysregulation and its relationship to health-related outcomes in children with cancer, and interventions to support circadian rhythmicity, is urgently needed.",2020,"Controlling for age, more dysregulated amplitude (p = 0.001), r24 (p = 0.003), IS (p = 0.017), and IV (p = 0.001) were associated with higher parent-reported fatigue; more dysregulated IV (p = 0.003) was associated with higher child-reported fatigue.
","['Participants aged 4-19\xa0years wore an actigraph throughout their hospitalization (5\xa0days', 'hospitalized children with CNS cancers receiving high-dose chemotherapy', 'Thirty-three participants were included', 'children and adolescents with central nervous system cancers hospitalized for high-dose chemotherapy (HDCT', 'Adult cancer patients with dysregulated circadian activity rhythms (CAR', 'children with cancer']",['cognitive-behavioral intervention'],"['fatigue', 'child fatigue and child/adolescent self-reported fatigue measures', 'amplitude, 24-h autocorrelation (r24), dichotomy index (I < O), interdaily stability (IS), intradaily variability (IV), and acrophase']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0008098', 'cui_str': 'Children, Hospitalized'}, {'cui': 'C0085136', 'cui_str': 'Neoplasm of central nervous system'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0348374', 'cui_str': 'Malignant neoplasm of central nervous system'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004381', 'cui_str': 'Automobile'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",33.0,0.04269,"Controlling for age, more dysregulated amplitude (p = 0.001), r24 (p = 0.003), IS (p = 0.017), and IV (p = 0.001) were associated with higher parent-reported fatigue; more dysregulated IV (p = 0.003) was associated with higher child-reported fatigue.
","[{'ForeName': 'Valerie E', 'Initials': 'VE', 'LastName': 'Rogers', 'Affiliation': 'University of Maryland, 655 W. Lombard Street, Baltimore, MD, 21201, USA. verogers@umaryland.edu.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'University of Maryland, 655 W. Lombard Street, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Belinda N', 'Initials': 'BN', 'LastName': 'Mandrell', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Ancoli-Israel', 'Affiliation': 'University of California, San Diego, CA, USA.'}, {'ForeName': 'Lianqi', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'University of California, San Diego, CA, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Hinds', 'Affiliation': ""Nursing, Children's National Health System and George Washington University, Washington, DC, USA.""}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-04960-5']
341,31373174,"Pharmacokinetic and Safety Profiles of a Fixed-Dose Combination of Amlodipine, Valsartan, and Atorvastatin: A 3-Period Replicate Crossover Study.","The objective of study was to compare the pharmacokinetic and safety profiles of a fixed-dose combination (FDC) formulation of 5/160/20 mg amlodipine/valsartan/atorvastatin with those of separate formulations of a 5/160-mg amlodipine/valsartan tablet and a 20-mg atorvastatin tablet. This was a randomized, open-label, single-dose, 3-sequence, 3-period replicate crossover study with 42 subjects. Serial blood samples for pharmacokinetic assessment were collected up to 72 hours postdose. For establishing bioequivalence (BE) for amlodipine, valsartan, and atorvastatin, a reference-scaled average BE approach was used if applicable, as well as the conventional limit of 0.80-1.25. The 90% confidence intervals (CIs) for the geometric mean ratios (GMRs) for the maximum plasma concentration (C max  ) and the area under the curve to the last measurable concentration (AUC t  ) between the FDC and separate formulations were within the 0.80-1.25 limit for all analytes but atorvastatin. The estimated within-subject standard deviation of the log-transformed values of the separate formulations, the reference intervention, was 0.3804 for the C max  of atorvastatin, being set at 0.7489-1.3352 for the BE acceptance limit. For both the C max  and AUC t  for atorvastatin, the GMRs lay within 0.80-1.25, and the 90%CIs for the GMRs were within the BE acceptance limit. This 3-period replicate crossover study demonstrated the BE of the FDC formulation of amlodipine, valsartan, and atorvastatin and the separate formulations of an amlodipine/valsartan tablet and an atorvastatin tablet. A similar incidence of treatment-emergent adverse events (TEAEs) was observed in both interventions, and headache was the most common TEAE.",2020,"A similar incidence of treatment-emergent adverse events (TEAEs) was observed in both interventions, and headache was the most common TEAE.",['42 subjects'],"['atorvastatin', 'amlodipine/valsartan tablet and an atorvastatin tablet', 'Amlodipine, Valsartan, and Atorvastatin', 'amlodipine/valsartan tablet and a 20-mg atorvastatin tablet', 'amlodipine/valsartan/atorvastatin', 'amlodipine, valsartan, and atorvastatin']","['pharmacokinetic and safety profiles', 'headache', 'geometric mean ratios (GMRs) for the maximum plasma concentration (C max  ) and the area under the curve to the last measurable concentration (AUC t  ']",[],"[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1962523', 'cui_str': 'Amlodipine / valsartan'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",,0.0202393,"A similar incidence of treatment-emergent adverse events (TEAEs) was observed in both interventions, and headache was the most common TEAE.","[{'ForeName': 'Seokuee', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jae-Wook', 'Initials': 'JW', 'LastName': 'Ko', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Jung-Ryul', 'Initials': 'JR', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Samsung Medical Center, Seoul, Republic of Korea.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.727']
342,32162822,Talazoparib in Patients with a Germline BRCA-Mutated Advanced Breast Cancer: Detailed Safety Analyses from the Phase III EMBRACA Trial.,"BACKGROUND


In the EMBRACA phase III study (NCT01945775), talazoparib was associated with a significantly prolonged progression-free survival (PFS) compared with physician's choice of chemotherapy (PCT) in germline BRCA1/2-mutated HER2-negative advanced breast cancer (ABC). Herein, the safety profile of talazoparib is explored in detail.
MATERIALS AND METHODS


Overall, 412 patients received ≥1 dose of talazoparib (n = 286) or PCT (n = 126). Adverse events (AEs) were evaluated, including timing, duration, and potential overlap of selected AEs. The relationship between talazoparib plasma exposure and grade ≥3 anemia was analyzed. Time-varying Cox proportional hazard models assessed the impact of dose reductions on PFS. Patient-reported outcomes (PROs) in patients with common AEs and health resource utilization (HRU) were assessed in both treatment arms.
RESULTS


The most common AEs with talazoparib were hematologic (195 [68.2%] patients) and typically occurred within the first 3-4 months of receiving talazoparib. Grade 3-4 anemia lasted approximately 7 days for both arms. Overlapping grade 3-4 hematologic AEs were infrequent with talazoparib. Higher talazoparib exposure was associated with grade ≥3 anemia. Permanent discontinuation of talazoparib due to hematologic AEs was low (<2%). A total of 150 (52.4%) patients receiving talazoparib had AEs associated with dose reduction. Hematologic toxicities were managed by supportive care medication (including transfusion) and dose modifications. Among patients with anemia or nausea and/or vomiting AEs, PROs favored talazoparib. After accounting for the treatment-emergent period, talazoparib was generally associated with a lower rate of hospitalization and supportive care medication use compared with chemotherapy.
CONCLUSION


Talazoparib was associated with superior efficacy, favorable PROs, and lower HRU rate versus chemotherapy in gBRCA-mutated ABC. Toxicities were manageable with talazoparib dose modification and supportive care.
IMPLICATIONS FOR PRACTICE


Talazoparib was generally well tolerated in patients with germline BRCA-mutated HER2-negative advanced breast cancer in the EMBRACA trial. Common toxicities with talazoparib were primarily hematologic and infrequently resulted in permanent drug discontinuation (<2% of patients discontinued talazoparib due to hematologic toxicity). Hematologic toxicities typically occurred during the first 3-4 months of treatment and were managed by dose modifications and supportive care measures. A significant efficacy benefit, improved patient-reported outcomes, lower rate of health resource utilization and a tolerable safety profile support incorporating talazoparib into routine management of germline BRCA-mutated locally advanced/metastatic breast cancer.",2020,"After accounting for the treatment-emergent period, talazoparib was generally associated with a lower rate of hospitalization and supportive care medication use compared with chemotherapy.
","['patients with germline BRCA-mutated HER2-negative advanced breast cancer in the EMBRACA trial', 'Overall, 412 patients received ≥1 dose of', 'patients with anemia or nausea and/or vomiting AEs, PROs favored talazoparib', 'germline BRCA1/2-mutated HER2-negative advanced breast cancer (ABC', 'n =\u2009286) or', 'Patients with a Germline BRCA-Mutated Advanced Breast Cancer']","['PCT', 'talazoparib', 'Talazoparib', 'chemotherapy (PCT']","['timing, duration, and potential overlap of selected AEs', 'talazoparib plasma exposure and grade ≥3 anemia', 'Hematologic toxicities', 'hematologic', 'Toxicities', 'hematologic toxicity', 'superior efficacy, favorable PROs, and lower HRU rate', 'health resource utilization (HRU']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042965', 'cui_str': 'Vomitus (substance)'}, {'cui': 'C4042960', 'cui_str': '3H-Pyrido(4,3,2-de)phthalazin-3-one, 5-fluoro-8-(4-fluorophenyl)-2,7,8,9-tetrahydro-9-(1-methyl-1H-1,2,4-triazol-5-yl)-, (8S,9R)-'}]","[{'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C4042960', 'cui_str': '3H-Pyrido(4,3,2-de)phthalazin-3-one, 5-fluoro-8-(4-fluorophenyl)-2,7,8,9-tetrahydro-9-(1-methyl-1H-1,2,4-triazol-5-yl)-, (8S,9R)-'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0185027', 'cui_str': 'Imbrication (procedure)'}, {'cui': 'C4042960', 'cui_str': '3H-Pyrido(4,3,2-de)phthalazin-3-one, 5-fluoro-8-(4-fluorophenyl)-2,7,8,9-tetrahydro-9-(1-methyl-1H-1,2,4-triazol-5-yl)-, (8S,9R)-'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018741', 'cui_str': 'Health Resources'}, {'cui': 'C0042153', 'cui_str': 'use'}]",,0.0470351,"After accounting for the treatment-emergent period, talazoparib was generally associated with a lower rate of hospitalization and supportive care medication use compared with chemotherapy.
","[{'ForeName': 'Sara A', 'Initials': 'SA', 'LastName': 'Hurvitz', 'Affiliation': 'University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, USA.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Fehrenbacher', 'Affiliation': 'Kaiser Permanente, Northern California, Vallejo, California, USA.'}, {'ForeName': 'Lida A', 'Initials': 'LA', 'LastName': 'Mina', 'Affiliation': 'MD Anderson Cancer Center, Gilbert, Arizona, USA.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Diab', 'Affiliation': 'Rocky Mountain Cancer Centers, Littleton, Colorado, USA.'}, {'ForeName': 'Joanne L', 'Initials': 'JL', 'LastName': 'Blum', 'Affiliation': 'Baylor Sammons Cancer Center, Texas Oncology, U.S. Oncology, Dallas, Texas, USA.'}, {'ForeName': 'Jayeta', 'Initials': 'J', 'LastName': 'Chakrabarti', 'Affiliation': 'Pfizer Ltd, Surrey, United Kingdom.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elmeliegy', 'Affiliation': 'Pfizer, Inc., La Jolla, California, USA.'}, {'ForeName': 'Liza', 'Initials': 'L', 'LastName': 'DeAnnuntis', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gauthier', 'Affiliation': 'Pfizer Inc., San Francisco, California, USA.'}, {'ForeName': 'Akos', 'Initials': 'A', 'LastName': 'Czibere', 'Affiliation': 'Pfizer Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Iulia Cristina', 'Initials': 'IC', 'LastName': 'Tudor', 'Affiliation': 'Pfizer Inc., San Francisco, California, USA.'}, {'ForeName': 'Ruben G W', 'Initials': 'RGW', 'LastName': 'Quek', 'Affiliation': 'Pfizer Inc., San Francisco, California, USA.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Litton', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Ettl', 'Affiliation': 'Department of Obstetrics and Gynecology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}]",The oncologist,['10.1634/theoncologist.2019-0493']
343,32170665,Safety of OnabotulinumtoxinA with Concomitant Antithrombotic Therapy in Patients with Muscle Spasticity: A Retrospective Pooled Analysis of Randomized Double-Blind Studies.,"BACKGROUND


OnabotulinumtoxinA is approved as a treatment across multiple indications. For the treatment of spasticity, onabotulinumtoxinA is injected directly into affected muscles. Intramuscular injections may result in local bleeding and related complications, especially in patients receiving anticoagulant therapy. Despite anticoagulants being commonly used, there is limited information in the medical literature regarding the safety of intramuscular medications in patients receiving oral anticoagulants. This retrospective analysis included pooled safety data from Allergan-sponsored studies evaluating onabotulinumtoxinA for the treatment of patients with muscle spasticity.
OBJECTIVE


The objective of this study was to determine the risk of bleeding complications in patients with post-stroke spasticity receiving antithrombotic therapy and intramuscular onabotulinumtoxinA.
METHODS


We conducted a retrospective analysis of pooled safety data from 16 randomized, double-blind, placebo-controlled Allergan-sponsored studies of onabotulinumtoxinA for the treatment of post-stroke upper or lower limb muscle spasticity, including adult patients with at least moderate upper or lower limb spasticity and receiving at least one dose of the study drug. Bleeding-related adverse events starting within 4 weeks of study treatment were assessed. The incidence rates of bleeding complications were compared for patients receiving classes of antithrombotic therapy vs those not receiving antithrombotic therapy and for those receiving onabotulinumtoxinA vs placebo (with or without antithrombotic therapy).
RESULTS


Of 1877 patients, 1182 received antithrombotic therapy. The overall incidence of bleeding complications was < 2%. In those receiving any antithrombotic therapy, the incidence of bleeding was 1.0% vs 1.4% (no antithrombotic therapy); after onabotulinumtoxinA, it was 0.9% for those receiving antithrombotic therapy vs 1.4% (no antithrombotic therapy), and for placebo 1.2% vs 1.4%, respectively. Subgroup results were similar.
CONCLUSIONS


No apparent increased risk of bleeding complications was observed following administration of onabotulinumtoxinA to patients receiving antithrombotic therapy. Nonetheless, patient education and careful observation of the injection site in patients receiving antithrombotic therapy remains warranted.",2020,No apparent increased risk of bleeding complications was observed following administration of onabotulinumtoxinA to patients receiving antithrombotic therapy.,"['patients with muscle spasticity', 'patients receiving oral anticoagulants', 'adult patients with at least moderate upper or lower limb spasticity and receiving at least one dose of the study drug', '1877 patients, 1182 received antithrombotic therapy', 'patients receiving anticoagulant therapy', 'patients with post-stroke spasticity receiving', 'Patients with Muscle Spasticity']","['antithrombotic therapy', 'onabotulinumtoxinA vs placebo', 'onabotulinumtoxinA', 'OnabotulinumtoxinA with Concomitant Antithrombotic Therapy', 'placebo-controlled Allergan-sponsored studies of onabotulinumtoxinA', 'antithrombotic therapy and intramuscular onabotulinumtoxinA']","['incidence of bleeding', 'overall incidence of bleeding complications', 'risk of bleeding complications', 'incidence rates of bleeding complications', 'local bleeding and related complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1271100', 'cui_str': 'Lower limb spasticity'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy (procedure)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}]",1877.0,0.23452,No apparent increased risk of bleeding complications was observed following administration of onabotulinumtoxinA to patients receiving antithrombotic therapy.,"[{'ForeName': 'Rozalina', 'Initials': 'R', 'LastName': 'Dimitrova', 'Affiliation': 'Allergan plc, 2525 Dupont Drive; T1-1B, Irvine, CA, 92623-9534, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'James', 'Affiliation': 'Allergan plc, 2525 Dupont Drive; T1-1B, Irvine, CA, 92623-9534, USA.'}, {'ForeName': 'Chengcheng', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Allergan plc, Bridgewater, NJ, USA.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Orejudos', 'Affiliation': 'Allergan plc, Bridgewater, NJ, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Yushmanova', 'Affiliation': 'Allergan plc, 2525 Dupont Drive; T1-1B, Irvine, CA, 92623-9534, USA.'}, {'ForeName': 'Mitchell F', 'Initials': 'MF', 'LastName': 'Brin', 'Affiliation': 'Allergan plc, 2525 Dupont Drive; T1-1B, Irvine, CA, 92623-9534, USA. Brin_Mitchell@allergan.com.'}]",CNS drugs,['10.1007/s40263-020-00709-5']
344,31300577,Effect of Electronic Cigarettes on Smoking Reduction and Cessation in Korean Male Smokers: A Randomized Controlled Study.,"INTRODUCTION


New approaches to electronic cigarettes (e-cigarettes) as a form of nicotine replacement therapy (NRT) may reduce the rates of tobacco-related disease and mortality. Therefore, we investigated the effect of e-cigarettes on smoking cessation compared with nicotine gum.
METHODS


A total of 150 subjects were randomly assigned to 2 groups and each was allocated a 12-week supply of either e-cigarettes or nicotine gum. The continuous abstinence rate, 7-day point prevalence of abstinence, smoking reduction rate and amount, and tolerability were evaluated.
RESULTS


There were no statistically significant differences in the effectiveness-related parameters of smoking cessation, such as 9- to 12-week, 9- to 24-week, and 12- and 24-week point prevalence of abstinence, between the 2 groups. However, although the reduction in cigarette smoking was similar, the proportion of subjects who showed smoking reduction at 24 weeks was higher in the e-cigarette group than the nicotine gum group. In addition, adverse events were significantly less frequent in the e-cigarette group than in the nicotine gum group.
CONCLUSIONS


In our study, the effect of e-cigarettes on smoking cessation was similar compared with that of nicotine gum, a well-documented NRT. In addition, e-cigarettes were well tolerated by the study population. Therefore, the use of e-cigarettes as an NRT may be considered for smoking-cessation purposes. A large-scale prospective randomized controlled trial is necessary to clarify our results.",2019,"There were no statistically significant differences in the effectiveness-related parameters of smoking cessation, such as 9- to 12-week, 9- to 24-week, and 12- and 24-week point prevalence of abstinence, between the 2 groups.","['Korean Male Smokers', 'A total of 150 subjects']","['Electronic Cigarettes', 'nicotine gum', 'nicotine replacement therapy (NRT', 'e-cigarettes or nicotine gum']","['adverse events', 'continuous abstinence rate, 7-day point prevalence of abstinence, smoking reduction rate and amount, and tolerability', 'effectiveness-related parameters of smoking cessation', 'cigarette smoking', 'Smoking Reduction and Cessation', 'smoking cessation', 'smoking reduction']","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1378701', 'cui_str': 'Gum (basic dose form)'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}]",150.0,0.0140052,"There were no statistically significant differences in the effectiveness-related parameters of smoking cessation, such as 9- to 12-week, 9- to 24-week, and 12- and 24-week point prevalence of abstinence, between the 2 groups.","[{'ForeName': 'Seung-Hwa', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'From Department of Family Medicine, Seohae Hospital, Seocheon, Republic of Korea (S-HL); Department of Family Practice and Community Health, Smoking Cessation Center, Ajou University School of Medicine, Suwon, Republic of Korea (S-HL); Department of Family Medicine, Seoul National University Hospital, Seoul, Republic of Korea (S-HA); Department of Family Medicine, Smoking Cessation Center, Dankook University College of Medicine, Cheonan, Republic of Korea (Y-SC).'}, {'ForeName': 'Sang-Hyun', 'Initials': 'SH', 'LastName': 'Ahn', 'Affiliation': 'From Department of Family Medicine, Seohae Hospital, Seocheon, Republic of Korea (S-HL); Department of Family Practice and Community Health, Smoking Cessation Center, Ajou University School of Medicine, Suwon, Republic of Korea (S-HL); Department of Family Medicine, Seoul National University Hospital, Seoul, Republic of Korea (S-HA); Department of Family Medicine, Smoking Cessation Center, Dankook University College of Medicine, Cheonan, Republic of Korea (Y-SC).'}, {'ForeName': 'Yoo-Seock', 'Initials': 'YS', 'LastName': 'Cheong', 'Affiliation': 'From Department of Family Medicine, Seohae Hospital, Seocheon, Republic of Korea (S-HL); Department of Family Practice and Community Health, Smoking Cessation Center, Ajou University School of Medicine, Suwon, Republic of Korea (S-HL); Department of Family Medicine, Seoul National University Hospital, Seoul, Republic of Korea (S-HA); Department of Family Medicine, Smoking Cessation Center, Dankook University College of Medicine, Cheonan, Republic of Korea (Y-SC). fmdoctor@hanmail.net.'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2019.04.180384']
345,31250992,A First-in-Human Phase 1 Randomized Single and Multiple Ascending Dose Study of RPh201 in Healthy Volunteers.,"RPh201 is a drug extracted from gum mastic that has been studied for its anti-inflammatory and antibacterial properties. Preclinical studies of RPh201 demonstrated neuroprotective and neuroenhancing effects. Toxicology studies in animals did not reveal safety concerns or genotoxic effects. This single-center, phase 1, randomized, placebo-controlled, double-masked study in healthy volunteers assessed the safety and tolerability of RPh201, and determined the highest tolerated dose. There were 2 parts: a single ascending dose (SAD) stage, followed by a multiple ascending dose (MAD) stage. Three dosing arms were included in each stage (5 mg, 10 mg, and 20 mg). Safety data in the lower dosing arms were evaluated before higher doses were initiated. Eighteen participants were randomized in the SAD stage: 12 to RPh201 (4 at each dose) and 4 to placebo. Twenty-one participants were randomized in the MAD stage, of which 13 received RPh201. All 18 participants in the SAD stage completed treatment. Sixteen of the 21 participants in the MAD stage completed treatment. The most frequently reported adverse events were local injection site pain and erythema. No deaths or adverse events related to changes in vital signs or electrocardiograms were reported. No occurrences of suicidal behavior or ideation were reported.",2020,No deaths or adverse events related to changes in vital signs or electrocardiograms were reported.,"['All 18 participants in the SAD stage completed treatment', 'Healthy Volunteers', 'healthy volunteers', 'Sixteen of the 21 participants in the MAD stage completed treatment', 'Eighteen participants']",['placebo'],"['suicidal behavior or ideation', 'safety and tolerability of RPh201', 'deaths or adverse events']","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0671759', 'cui_str': 'MAD'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",21.0,0.155135,No deaths or adverse events related to changes in vital signs or electrocardiograms were reported.,"[{'ForeName': 'Zadik', 'Initials': 'Z', 'LastName': 'Hazan', 'Affiliation': 'Regenera Pharma Ltd., Ness Ziona, Israel.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Adamsky', 'Affiliation': 'Regenera Pharma Ltd., Ness Ziona, Israel.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Lucassen', 'Affiliation': 'Regenera Pharma Ltd., Ness Ziona, Israel.'}, {'ForeName': 'Leonard A', 'Initials': 'LA', 'LastName': 'Levin', 'Affiliation': 'Departments of Ophthalmology & Visual Sciences and Neurology & Neurosurgery, McGill University, Montreal, Canada.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.720']
346,32162796,Effect of a Skills Training for Oncologists and a Patient Communication Aid on Shared Decision Making About Palliative Systemic Treatment: A Randomized Clinical Trial.,"BACKGROUND


Palliative systematic treatment offers uncertain and often limited benefits, and the burden can be high. Hence, treatment decisions require shared decision making (SDM). This trial examined the independent and combined effect of an oncologist training and a patient communication aid on SDM.
METHODS


In this multicenter randomized controlled trial with four parallel arms (2016-2018), oncologists (n = 31) were randomized to receive SDM communication skills training or not. The training consisted of a reader, two group sessions, a booster session, and a consultation room tool (10 hours). Patients (n = 194) with advanced cancer were randomized to receive a patient communication aid or not. The aid consisted of education on SDM, a question prompt list, and a value clarification exercise. The primary outcome was observed SDM as rated by blinded observers from audio-recorded consultations. Secondary outcomes included patient-reported SDM, patient and oncologist satisfaction, patients' decisional conflict, patient quality of life 3 months after consultation, consultation duration, and the decision made.
RESULTS


The oncologist training had a large positive effect on observed SDM (Cohen's d = 1.12) and on patient-reported SDM (d = 0.73). The patient communication aid did not improve SDM. The combination of interventions did not add to the effect of training oncologists only. The interventions affected neither patient nor oncologist satisfaction with the consultation nor patients' decisional conflict, quality of life, consultation duration, or the decision made.
CONCLUSION


Training medical oncologists in SDM about palliative systemic treatment improves both observed and patient-reported SDM. A patient communication aid does not. The incorporation of skills training in (continuing) educational programs for medical oncologists is likely to stimulate the widely advocated uptake of shared decision making in clinical practice.
TRIAL REGISTRATION


Netherlands Trial Registry NTR 5489.
IMPLICATIONS FOR PRACTICE


Treatment for advanced cancer offers uncertain and often small benefits, and the burden can be high. Hence, treatment decisions require shared decision making (SDM). SDM is increasingly advocated for ethical reasons and for its beneficial effect on patient outcomes. Few initiatives to stimulate SDM are evaluated in robust designs. This randomized controlled trial shows that training medical oncologists improves both observed and patient-reported SDM in clinical encounters (n = 194). A preconsultation communication aid for patients did not add to the effect of training oncologists. SDM training effectively changes oncologists' practice and should be implemented in (continuing) educational programs.",2020,"The interventions affected neither patient nor oncologist satisfaction with the consultation nor patients' decisional conflict, quality of life, consultation duration, or the decision made.
","['four parallel arms (2016-2018), oncologists (n =\u200931', 'Patients (n =\u2009194) with advanced cancer', 'Oncologists and a Patient Communication Aid on Shared Decision Making About Palliative Systemic Treatment']","['SDM communication skills training or not', 'oncologist training', 'patient communication aid or not', 'SDM', 'Skills Training', 'SDM training']","['decisional conflict, quality of life, consultation duration, or the decision made', 'SDM', 'observed SDM', ""patient-reported SDM, patient and oncologist satisfaction, patients' decisional conflict, patient quality of life 3 months after consultation, consultation duration, and the decision made""]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0542278', 'cui_str': 'Communication aid (physical object)'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training (procedure)'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0542278', 'cui_str': 'Communication aid (physical object)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.162469,"The interventions affected neither patient nor oncologist satisfaction with the consultation nor patients' decisional conflict, quality of life, consultation duration, or the decision made.
","[{'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Henselmans', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hanneke W M', 'Initials': 'HWM', 'LastName': 'van Laarhoven', 'Affiliation': 'Department of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Pomme', 'Initials': 'P', 'LastName': 'van Maarschalkerweerd', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Hanneke C J M', 'Initials': 'HCJM', 'LastName': 'de Haes', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics, and Bioinformatics, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Dirkje W', 'Initials': 'DW', 'LastName': 'Sommeijer', 'Affiliation': 'Department of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Petronella B', 'Initials': 'PB', 'LastName': 'Ottevanger', 'Affiliation': 'Department of Medical Oncology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Helle-Brit', 'Initials': 'HB', 'LastName': 'Fiebrich', 'Affiliation': 'Department of Medical Oncology, Isalaklinieken, Zwolle, The Netherlands.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Dohmen', 'Affiliation': 'Department of Medical Oncology, BovenIJZiekenhuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Creemers', 'Affiliation': 'Department of Medical Oncology, Catharinaziekenhuis, Eindhoven, The Netherlands.'}, {'ForeName': 'Filip Y F L', 'Initials': 'FYFL', 'LastName': 'de Vos', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Ellen M A', 'Initials': 'EMA', 'LastName': 'Smets', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.'}]",The oncologist,['10.1634/theoncologist.2019-0453']
347,32162804,The McCAVE Trial: Vanucizumab plus mFOLFOX-6 Versus Bevacizumab plus mFOLFOX-6 in Patients with Previously Untreated Metastatic Colorectal Carcinoma (mCRC).,"BACKGROUND


Bevacizumab, a VEGF-A inhibitor, in combination with chemotherapy, has proven to increase progression-free survival (PFS) and overall survival in multiple lines of therapy of metastatic colorectal cancer (mCRC). The angiogenic factor angiopoetin-2 (Ang-2) is associated with poor prognosis in many cancers, including mCRC. Preclinical models demonstrate improved activity when inhibiting both VEGF-A and Ang-2, suggesting that the dual VEGF-A and Ang-2 blocker vanucizumab (RO5520985 or RG-7221) may improve clinical outcomes. This phase II trial evaluated the efficacy of vanucizumab plus modified (m)FOLFOX-6 (folinic acid (leucovorin), fluorouracil (5-FU) and oxaliplatin) versus bevacizumab/mFOLFOX-6 for first-line mCRC.
PATIENTS AND METHODS


All patients received mFOLFOX-6 and were randomized 1:1 to also receive vanucizumab 2,000 mg or bevacizumab 5 mg/kg every other week. Oxaliplatin was given for eight cycles; other agents were continued until disease progression or unacceptable toxicity for a maximum of 24 months. The primary endpoint was investigator-assessed PFS.
RESULTS


One hundred eighty-nine patients were randomized (vanucizumab, n = 94; bevacizumab, n = 95). The number of PFS events was comparable (vanucizumab, n = 39; bevacizumab, n = 43). The hazard ratio was 1.00 (95% confidence interval, 0.64-1.58; p = .98) in a stratified analysis based on number of metastatic sites and region. Objective response rate was 52.1% and 57.9% in the vanucizumab and bevacizumab arm, respectively. Baseline plasma Ang-2 levels were prognostic in both arms but not predictive for treatment effects on PFS of vanucizumab. The incidence of adverse events of grade ≥3 was similar between treatment arms (83.9% vs. 82.1%); gastrointestinal perforations (10.8% vs. 8.4%) exceeded previously reported rates in this setting. Hypertension and peripheral edema were more frequent in the vanucizumab arm.
CONCLUSION


Vanucizumab/mFOLFOX-6 did not improve PFS and was associated with increased rates of antiangiogenic toxicity compared with bevacizumab/mFOLFOX-6. Our results suggest that Ang-2 is not a relevant therapeutic target in first-line mCRC.
IMPLICATIONS FOR PRACTICE


This randomized phase II study demonstrates that additional angiopoietin-2 (Ang-2) inhibition does not result in superior benefit over anti-VEGF-A blockade alone when each added to standard chemotherapy. Moreover, the performed pharmacokinetic and pharmacodynamic analysis revealed that vanucizumab was bioavailable and affected its intended target, thereby strongly suggesting that Ang-2 is not a relevant therapeutic target in the clinical setting of treatment-naïve metastatic colorectal cancer. As a result, the further clinical development of the dual VEGF-A and Ang-2 inhibitor vanucizumab was discontinued.",2020,Baseline plasma Ang-2 levels were prognostic in both arms but not predictive for treatment effects on PFS of vanucizumab.,"['One hundred eighty-nine patients', 'Patients with Previously Untreated Metastatic Colorectal Carcinoma (mCRC', 'All patients received mFOLFOX-6']","['vanucizumab plus modified (m)FOLFOX-6 (folinic acid (leucovorin), fluorouracil (5-FU) and oxaliplatin', 'vanucizumab 2,000 mg or bevacizumab', 'Oxaliplatin', 'vanucizumab and bevacizumab', 'Bevacizumab', 'Bevacizumab plus mFOLFOX-6', 'bevacizumab', 'bevacizumab/mFOLFOX-6', 'Vanucizumab plus mFOLFOX-6']","['hazard ratio', 'rates of antiangiogenic toxicity', 'incidence of adverse events of grade ≥3', 'number of PFS events', 'investigator-assessed PFS', 'Hypertension and peripheral edema', 'progression-free survival (PFS) and overall survival', 'PFS', 'gastrointestinal perforations', 'Objective response rate']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0009402', 'cui_str': 'Colorectal Carcinoma'}]","[{'cui': 'C4331496', 'cui_str': 'vanucizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1963976', 'cui_str': 'Gastrointestinal perforation (SMQ)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",189.0,0.110282,Baseline plasma Ang-2 levels were prognostic in both arms but not predictive for treatment effects on PFS of vanucizumab.,"[{'ForeName': 'Johanna C', 'Initials': 'JC', 'LastName': 'Bendell', 'Affiliation': 'Sarah Cannon Research Institute and Tennessee Oncology, Nashville, Tennessee, USA.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Sauri', 'Affiliation': ""Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Antonio Cubillo', 'Initials': 'AC', 'LastName': 'Gracián', 'Affiliation': 'Centro Integral Oncológico Clara Campal, Hospital Madrid Norte Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Alvarez', 'Affiliation': 'Centro Integral Oncológico Clara Campal, Hospital Madrid Norte Sanchinarro, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'López-López', 'Affiliation': 'Marqués de Valdecilla University Hospital, Santander, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'García-Alfonso', 'Affiliation': 'Hospital Universitario Gregorio Maranon, Madrid, Spain.'}, {'ForeName': 'Maen', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'Florida Cancer Specialists, Leesburg, Florida, USA.'}, {'ForeName': 'Maria-Luisa Limon', 'Initials': 'ML', 'LastName': 'Miron', 'Affiliation': 'Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Cervantes', 'Affiliation': 'Department of Medical Oncology, Biomedical Research Institute, INCLIVA, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Montagut', 'Affiliation': 'Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Cristina Santos', 'Initials': 'CS', 'LastName': 'Vivas', 'Affiliation': ""Institut Català d'Oncologia and L'Institut d'Investigació Biomèdica de Bellvitge (IDIBELL), L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bessudo', 'Affiliation': 'California Cancer Associates for Research and Excellence, San Diego, California, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Plezia', 'Affiliation': 'Arizona Clinical Research Center, Tucson, Arizona, USA.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Moons', 'Affiliation': 'Imelda General Hospital, Bonheiden, Belgium.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Andel', 'Affiliation': 'County Hospital Steyr, Steyr, Austria.'}, {'ForeName': 'Jaafar', 'Initials': 'J', 'LastName': 'Bennouna', 'Affiliation': ""Institut de Cancerologie de l'Ouest, Saint Herblain, France.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'van der Westhuizen', 'Affiliation': 'Calvary Mater Hospital, Newcastle, Australia.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Samuel', 'Affiliation': 'Aberdeen Royal Infirmary, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Rossomanno', 'Affiliation': 'Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Boetsch', 'Affiliation': 'Roche Innovation Center Basel, Basel, Switzerland.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Lahr', 'Affiliation': 'Roche Innovation Center Munich, Penzberg, Germany.'}, {'ForeName': 'Izolda', 'Initials': 'I', 'LastName': 'Franjkovic', 'Affiliation': 'Roche Innovation Center Munich, Penzberg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Heil', 'Affiliation': 'Roche Innovation Center Munich, Penzberg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Lechner', 'Affiliation': 'Roche Innovation Center Munich, Penzberg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Krieter', 'Affiliation': 'Roche Innovation Center Munich, Penzberg, Germany.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Hurwitz', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The oncologist,['10.1634/theoncologist.2019-0291']
348,31176727,Determining the biological associates of acute cold pressor post-encoding stress effects on human memory: The role of salivary interleukin-1β.,"Stress generally hurts many aspects of memory, but an interesting finding to emerge from the stress and memory literature is that stress that occurs shortly after learning (i.e., post-encoding stress) usually benefits memory. Although this effect is well established, the biological mechanisms underpinning this effect are not-especially in humans. We addressed this gap in the present study by collecting saliva samples from 80 participants who were randomized to a post-encoding stress (i.e., cold pressor for 3 min) or control task (i.e., warm water for 3 min) and 48 h later completed a recognition memory task. Saliva was collected both prior to and 15 min after the offset of (18 min after the onset of) the stress/control manipulation. Drawing on animal and human work, we examined how five stress-responsive biomarkers-cortisol, salivary α-amylase, progesterone, estradiol, and the proinflammatory cytokine interleukin (IL)-1β, all assessed in saliva-related to the effects of stress on memory. We found that stress enhanced recollection of negative images and that these effects were selectively related to salivary IL-1β. Moreover, we found that the beneficial effects of stress on memory were statistically mediated by salivary IL-1β. We found no robust associations-either linear or quadratic-between memory and any other biomarker, nor did we find significant interactions between biomarkers in predicting memory. These results suggest that immune system activity indexed by salivary IL-1β may play an important role in contributing to post-encoding stress effects on human memory.",2019,We found that stress enhanced recollection of negative images and that these effects were selectively related to salivary IL-1β.,"['80 participants who were randomized to a', 'human memory']","['post-encoding stress (i.e., cold pressor for 3\u202fmin) or control task (i.e., warm water for 3\u202fmin) and 48\u202fh later completed a recognition memory task', 'salivary interleukin-1β']",['salivary IL-1β'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0025260', 'cui_str': 'Memory'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}]",80.0,0.0340848,We found that stress enhanced recollection of negative images and that these effects were selectively related to salivary IL-1β.,"[{'ForeName': 'Grant S', 'Initials': 'GS', 'LastName': 'Shields', 'Affiliation': 'Center for Mind and Brain, University of California, Davis, United States. Electronic address: gsshields@ucdavis.edu.'}, {'ForeName': 'Tiffany M', 'Initials': 'TM', 'LastName': 'Dunn', 'Affiliation': 'Department of Psychology, University of California, Davis, United States.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Trainor', 'Affiliation': 'Department of Psychology, University of California, Davis, United States.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Yonelinas', 'Affiliation': 'Department of Psychology, University of California, Davis, United States; Center for Neuroscience, University of California, Davis, United States.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.06.011']
349,31473126,Standardization of phototherapy for neonatal hyperbilirubinemia using multiple-wavelength irradiance integration.,"BACKGROUND


Phototherapy with radiation of 460-490 nm wavelengths provides the most potent therapeutic effect for neonatal jaundice. However, the efficacy of phototherapy has been estimated using single-wavelength detectors with sensitivity at approximately 460 nm. Cyclobilirubin formation capacity (CFC), which comprises the sum of the irradiance values from three wavelengths multiplied by their specific coefficients, has been proposed as an alternative marker to evaluate the efficacy of phototherapy. This study aimed to test whether two types of phototherapy devices with distinct spectral characteristics provide similar therapeutic effects on adjustment of device-to-patient distances to deliver similar CFCs.
METHODS


Using a three-wavelength spectroradiometer, CFCs and footprints of the light-emitting diode and fluorescent tube devices were assessed. Having determined the device-specific distances that ensured similar CFCs, 32 newborn infants, requiring phototherapy for hyperbilirubinemia, were randomized into the light-emitting diode and fluorescent tube groups. The total serum bilirubin levels before and after phototherapy were assessed.
RESULTS


The light-emitting diode and fluorescent tube devices had comparable CFCs at distances of 60 and 50 cm, respectively. Phototherapy reduced the total serum bilirubin levels from 18.1 to 14.6 mg/dL and from 19.1 to 15.1 mg/dL in the light-emitting diode and fluorescent tube groups, respectively. The two groups did not differ significantly with respect to the patients' clinical backgrounds, serum bilirubin levels, or changes before and after phototherapy.
CONCLUSION


At similar CFCs, the two phototherapy devices reduced the total serum bilirubin levels by comparable amounts. Hence, determining CFCs may help predict phototherapy efficacy. This may ensure better safety and greater efficacy of the treatment for newborn infants.",2020,"The two groups did not differ significantly with respect to the patients' clinical backgrounds, serum bilirubin levels, or changes before and after phototherapy.
","['newborn infants', '32 newborn infants, requiring phototherapy for hyperbilirubinemia']","['Phototherapy', 'phototherapy']","[""patients' clinical backgrounds, serum bilirubin levels"", 'total serum bilirubin levels']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C0020433', 'cui_str': 'Bilirubinemia'}]","[{'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1287366', 'cui_str': 'Finding of serum bilirubin level (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0575006,"The two groups did not differ significantly with respect to the patients' clinical backgrounds, serum bilirubin levels, or changes before and after phototherapy.
","[{'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Department of Pediatrics and Neonatology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: shink@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Osuke', 'Initials': 'O', 'LastName': 'Iwata', 'Affiliation': 'Department of Pediatrics and Neonatology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.'}, {'ForeName': 'Yasumasa', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Department of Neonatology, Aichi Human Service Center Central Hospital, 713-8 Jinya-cho, Kasugai 480-0304, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Kakita', 'Affiliation': 'Department of Pediatrics and Neonatology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.'}, {'ForeName': 'Takaharu', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Department of Pediatrics, Kainan Hospital, 396 Minamihonda, Maegasu-cho, Yatomi 498-8502, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Nakashima', 'Affiliation': 'Department of Pediatrics, Seirei-Mikatahara General Hospital, 3453 Mikatahara-cho, Kita-ku, Hamamatsu 433-8558, Japan.'}, {'ForeName': 'Tokio', 'Initials': 'T', 'LastName': 'Sugiura', 'Affiliation': 'Department of Pediatrics and Neonatology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Department of Pediatrics and Neonatology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Department of Pediatrics, Nagoya City West Medical Center, 1-1-1 Hirate-Cho, Kita-ku, Nagoya 462-8508, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Togari', 'Affiliation': 'Department of Pediatrics and Neonatology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Department of Pediatrics, Nagoya City West Medical Center, 1-1-1 Hirate-Cho, Kita-ku, Nagoya 462-8508, Japan.'}]",Pediatrics and neonatology,['10.1016/j.pedneo.2019.07.002']
350,31474462,Analgesic effect of non-nutritive sucking in term neonates: A randomized controlled trial.,"BACKGROUND


Newborns commonly experience pain due to a variety of reasons. Non-nutritive sucking (NNS) is thought to be an effective non-pharmacological method of pain-relief. However, the significant heterogeneity in some systematic reviews limited the certainty of the findings about NNS. Hence, this study was aimed at evaluating the analgesic effect and safety of NNS in healthy term neonates during the heel prick test, using the Neonatal Pain Agitation and Sedation Scale (N-PASS).
METHODS


In this randomized controlled trial, 42 term infants were included: 22 infants in the intervention group (receiving NNS) and 20 infants in the control group (not receiving NNS). In the intervention group, neonates were given a silicone pacifier 120 s before, during, and 120 s after the heel puncture, while neonates in the control group received routine care. Pain-related outcomes were assessed using the N-PASS at 30s, 60s, 90s, and 120s after the heel prick. Any adverse events during the procedure were noted. The Spearman correlation coefficients between the pain scores on the N-PASS and two other scales (NFCS and NIPS) were calculated at all four moments of evaluation.
RESULTS


The mean N-PASS pain scores at 30s, 60s, 90s, and 120s after heel prick were significantly lower in the NNS group than in the control group: 4.73 ± 2.78 vs. 7.90 ± 1.52 (p = 0.0002); 3.64 ± 3.06 vs. 5.55 ± 2.95 (p = 0.052); 2.59 ± 3.08 vs. 5.25 ± 3.51 (p = 0.011); and 2.05 ± 2.94 vs. 4.90 ± 3.99 (p = 0.013), respectively. No adverse events were detected in either group. Our findings revealed a strong positive correlation between the pain scores on the N-PASS and two other scales (NFCS and NIPS), which was statistically significant (p < 0.01).
CONCLUSIONS


NNS is considered a safe and effective pain-relief method during the heel prick procedure in term neonates, demonstrated using the N-PASS. These findings were correlated with the pain evaluation by NFCS and NIPS.",2020,"The Spearman correlation coefficients between the pain scores on the N-PASS and two other scales (NFCS and NIPS) were calculated at all four moments of evaluation.
","['healthy term neonates during the heel prick test', 'term neonates', '42 term infants were included: 22 infants in the']","['routine care', 'intervention group (receiving NNS', 'NNS', 'silicone pacifier', 'non-nutritive sucking', 'nutritive sucking (NNS', 'control group (not receiving NNS']","['mean N-PASS pain scores', 'adverse events', 'pain evaluation', 'Neonatal Pain Agitation and Sedation Scale (N-PASS', 'Analgesic effect', 'pain scores']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0430561', 'cui_str': 'Prick test (procedure)'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0030172', 'cui_str': 'Pacifiers'}, {'cui': 'C1271035', 'cui_str': 'Provision of non-nutritive sucking (regime/therapy)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}]",,0.126464,"The Spearman correlation coefficients between the pain scores on the N-PASS and two other scales (NFCS and NIPS) were calculated at all four moments of evaluation.
","[{'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Vu-Ngoc', 'Affiliation': 'Faculty of Medicine, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Viet Nam; Faculty of Medicine, University Paris Descartes, Paris 75006, Ile-de-France, France.'}, {'ForeName': 'Nguyen Cao Minh', 'Initials': 'NCM', 'LastName': 'Uyen', 'Affiliation': 'Faculty of Medicine, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Ong Phuc', 'Initials': 'OP', 'LastName': 'Thinh', 'Affiliation': 'Faculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Le Duc', 'Initials': 'LD', 'LastName': 'Don', 'Affiliation': 'Faculty of Medicine, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Nguyen Vo Tan', 'Initials': 'NVT', 'LastName': 'Danh', 'Affiliation': 'Faculty of Medicine, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Nguyen Tran Thanh', 'Initials': 'NTT', 'LastName': 'Truc', 'Affiliation': 'Faculty of Medicine, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Vu Tuong', 'Initials': 'VT', 'LastName': 'Vi', 'Affiliation': 'Faculty of Public Health, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Nguyen Lam', 'Initials': 'NL', 'LastName': 'Vuong', 'Affiliation': 'Faculty of Medicine, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Nguyen Tien', 'Initials': 'NT', 'LastName': 'Huy', 'Affiliation': 'Institute of Research and Development, Duy Tan University, Da Nang 550000, Viet Nam. Electronic address: nguyentienhuy4@duytan.edu.vn.'}, {'ForeName': 'Pham Diep Thuy', 'Initials': 'PDT', 'LastName': 'Duong', 'Affiliation': 'Faculty of Medicine, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Viet Nam. Electronic address: thuyduongpd@ump.edu.vn.'}]",Pediatrics and neonatology,['10.1016/j.pedneo.2019.07.003']
351,31317668,The Pharmacokinetics and Relative Bioavailability of Mepolizumab 100 mg Liquid Formulation Administered Subcutaneously to Healthy Participants: A Randomized Trial.,"This study compared the pharmacokinetic (PK) profile of a new liquid formulation of mepolizumab with the established lyophilized formulation. In this open-label, parallel-group, single-dose study (NCT03014674; GSK ID: 204958), healthy participants were randomized (1:1:1) to receive a single mepolizumab dose (100 mg) administered subcutaneously as liquid in a single-use prefilled syringe or single-use prefilled autoinjector, or as a lyophilized formulation. Maximum plasma concentration, area under the plasma concentration-time curve from time zero (predose) to time of last quantifiable concentration (AUC 0-t  ), and AUC from time zero to infinity (AUC 0-∞  ) as well as additional PK parameters, safety assessments, and blood eosinophil count were evaluated. In total, 244 participants received study drug. All PK parameters were similar across the 3 groups; 90% confidence intervals for maximum plasma concentration, AUC 0-t  , and AUC 0-∞  treatment ratios (liquid prefilled syringe or autoinjector vs lyophilized formulation) were within conventional bioequivalence bounds (0.80-1.25), demonstrating statistical PK comparability. On-treatment adverse event incidence was 29% to 38%. Mepolizumab liquid formulation administered via prefilled syringe or autoinjector had similar PK properties to the lyophilized formulation, with no safety concerns identified.",2020,"All PK parameters were similar across the 3 groups; 90% confidence intervals for maximum plasma concentration, AUC 0-t  , and AUC 0-∞  treatment ratios (liquid prefilled syringe or autoinjector vs lyophilized formulation) were within conventional bioequivalence bounds (0.80-1.25), demonstrating statistical PK comparability.","['244 participants received study drug', 'healthy participants', 'Healthy Participants']","['Mepolizumab 100 mg Liquid Formulation Administered', 'single mepolizumab dose (100 mg) administered subcutaneously as liquid in a single-use prefilled syringe or single-use prefilled autoinjector, or as a lyophilized formulation']","['Maximum plasma concentration, area under the plasma concentration-time curve from time zero (predose) to time of last quantifiable concentration (AUC 0-t  ), and AUC from time zero to infinity (AUC 0-∞  ) as well as additional PK parameters, safety assessments, and blood eosinophil count', 'maximum plasma concentration, AUC 0-t  , and AUC 0-∞  treatment ratios']","[{'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4058348', 'cui_str': 'mepolizumab 100 MG [Nucala]'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1609474', 'cui_str': 'Prefilled Syringe'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",244.0,0.0347797,"All PK parameters were similar across the 3 groups; 90% confidence intervals for maximum plasma concentration, AUC 0-t  , and AUC 0-∞  treatment ratios (liquid prefilled syringe or autoinjector vs lyophilized formulation) were within conventional bioequivalence bounds (0.80-1.25), demonstrating statistical PK comparability.","[{'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Shabbir', 'Affiliation': 'GSK, Gunnels Wood Road, Stevenage, Hertfordshire, UK.'}, {'ForeName': 'Isabelle J', 'Initials': 'IJ', 'LastName': 'Pouliquen', 'Affiliation': 'GSK, Stockley Park, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Jane H', 'Initials': 'JH', 'LastName': 'Bentley', 'Affiliation': 'GSK, Stockley Park, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Bradford', 'Affiliation': 'GSK, Research Triangle Park, NC, USA.'}, {'ForeName': 'Morrys', 'Initials': 'M', 'LastName': 'C Kaisermann', 'Affiliation': 'GSK, Upper Providence, Collegeville, PA, USA.'}, {'ForeName': 'Muna', 'Initials': 'M', 'LastName': 'Albayaty', 'Affiliation': 'PAREXEL International, Northwick Park Hospital, Harrow, Middlesex, UK.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.726']
352,29979940,Postoperative respiratory muscle training in addition to chest physiotherapy after pulmonary resection: A randomized controlled study.,"Purpose : The effects of preoperative respiratory muscle training (RMT) on postoperative complications in patients with pulmonary resection have recently attracted the attention of researchers. More studies are obviously needed to clarify the effects of RMT after pulmonary resection. The aim of this study was to evaluate the effectiveness of intense RMT in addition to chest physiotherapy after pulmonary resection in terms of respiratory muscle strength, exercise capacity, and length of hospital stay rather than postoperative complications.  Methods : Forty subjects undergoing pulmonary resection were included in the study. Subjects were divided into two groups using a simple randomization method. The subjects in the study group (SG;  n  = 20) received RMT in addition to regular chest physiotherapy in the postoperative period. The subjects in the control group (CG;  n  = 20) received only regular chest physiotherapy. Respiratory muscle strength (maximal inspiratory and expiratory pressure [PI max  and PE max ]) was measured pre-postoperatively and before discharge, and exercise capacity, which was measured by the 6-min walk test (6MWT), was assessed preoperatively and before discharge. The length of hospital stay was also recorded.  Results : There were no differences between groups in terms of demographic and surgical characteristics. The nonsignificant change of PI max  from the preoperative to the discharge value was 65.1 ± 15.5 to 68.2 ± 19.2 cmH 2 O in SG and 59.2 ± 13.7 to 44.3 ± 14.8 cmH 2 O in CG ( p  > 0.05,  p  > 0.05, respectively). The change of PE max  from the preoperative to the discharge value was 80.4 ± 24.9 to 81.5 ± 24.9 cmH 2 O in SG (nonsignificant) and 85.4 ± 38.2 to 61.3 ± 25.4 cmH 2 O in CG ( p  > 0.05,  p  = 0.002, respectively). There was a significant difference between SG and CG in terms of RMT effect (PI max : 11.05 [21.84; 0.25] cmH 2 O  p  = 0.045; PE max : 25.23 [42.83; 7.62] cmH 2 O  p  = 0.006). A significant difference was found in the 6MWT when the mean differences were compared between the groups (85.72 [166.15; 5.28] m  p  = 0.037). The length of hospital stay was significantly shorter in the SG (number of days for SG 9.1 ± 3 and for CG 12.9 ± 4.2 [ p  = 0.002]).  Conclusion : The addition of RMT to chest physiotherapy after pulmonary resection can have positive effects on respiratory muscle strength, exercise capacity, and length of hospital stay.",2020,"Respiratory muscle strength (maximal inspiratory and expiratory pressure [PI max  and PE max ]) was measured pre-postoperatively and before discharge, and exercise capacity, which was measured by the 6-min walk test (6MWT), was assessed preoperatively and before discharge.","['patients with pulmonary resection', 'Forty subjects undergoing pulmonary resection were included in the study', 'after pulmonary resection']","['Postoperative respiratory muscle training in addition to chest physiotherapy', 'RMT', 'regular chest physiotherapy', 'preoperative respiratory muscle training (RMT', 'RMT in addition to regular chest physiotherapy']","['change of PE max', 'respiratory muscle strength, exercise capacity, and length of hospital stay rather', 'PI max', 'postoperative complications', 'RMT effect', 'length of hospital stay', 'respiratory muscle strength, exercise capacity, and length of hospital stay', '6-min walk test (6MWT', '6MWT', 'Respiratory muscle strength (maximal inspiratory and expiratory pressure [PI max  and PE max ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0006155', 'cui_str': 'Respiratory Muscle Training'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest (regime/therapy)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",40.0,0.0299514,"Respiratory muscle strength (maximal inspiratory and expiratory pressure [PI max  and PE max ]) was measured pre-postoperatively and before discharge, and exercise capacity, which was measured by the 6-min walk test (6MWT), was assessed preoperatively and before discharge.","[{'ForeName': 'Harun', 'Initials': 'H', 'LastName': 'Taşkin', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Orçin', 'Initials': 'O', 'LastName': 'Telli Atalay', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Yuncu', 'Affiliation': 'Department of Chest Surgery, Kent Hospital, İzmir, Turkey.'}, {'ForeName': 'Betül', 'Initials': 'B', 'LastName': 'Taşpinar', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Dumlupınar University, School of Health Sciences, Kütahya, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Yalman', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Denizli, Turkey.'}, {'ForeName': 'Hande', 'Initials': 'H', 'LastName': 'Şenol', 'Affiliation': 'Faculty of Medicine, Department of Biostatistics, Pamukkale University, Denizli, Turkey.'}]",Physiotherapy theory and practice,['10.1080/09593985.2018.1488189']
353,32251012,The Hearing Intervention for the Aging and Cognitive Health Evaluation in Elders Randomized Control Trial: Manualization and Feasibility Study.,"OBJECTIVES


This work describes the development of a manualized best-practice hearing intervention for older adults participating in the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) randomized controlled clinical trial. Manualization of interventions for clinical trials is critical for assuring intervention fidelity and quality, especially in large multisite studies. The multisite ACHIEVE randomized controlled trial is designed to assess the efficacy of a hearing intervention on rates of cognitive decline in older adults. We describe the development of the manualized hearing intervention through an iterative process that included addressing implementation questions through the completion of a feasibility study (ACHIEVE-Feasibility).
DESIGN


Following published recommendations for manualized intervention development, an iterative process was used to define the ACHIEVE-hearing intervention elements and create an initial manual. The intervention was then delivered within the ACHIEVE-Feasibility study using one-group pre-post design appropriate for assessing questions related to implementation. Participants were recruited from the Tampa, Florida area between May 2015 and April 2016. Inclusion criteria were cognitively healthy adults aged 70 to 89 with symmetrical mild-to-moderately severe sensorineural hearing loss. The ACHIEVE-Feasibility study sought to assess the implementation of the manualized hearing intervention by: (1) confirming improvement in expected outcomes were achieved including aided speech-in-noise performance and perception of disease-specific self-report measures; (2) determining whether the participants would comply with the intervention including session attendance and use of hearing aids; and (3) determining whether the intervention sessions could be delivered within a reasonable timeframe.
RESULTS


The initial manualized intervention that incorporated the identified best-practice elements was evaluated for feasibility among 21 eligible participants and 9 communication partners. Post-intervention expected outcomes were obtained with speech-in-noise performance results demonstrating a significant improvement under the aided condition and self-reported measures showing a significant reduction in self-perceived hearing handicap. Compliance was excellent, with 20 of the 21 participants (95.2%) completing all intervention sessions and 19 (90.4%) returning for the 6-month post-intervention visit. Furthermore, self-reported hearing aid compliance was >8 hr/day, and the average daily hearing aid use from datalogging was 7.8 hr. Study completion was delivered in a reasonable timeframe with visits ranging from 27 to 85 min per visit. Through an iterative process, the intervention elements were refined, and the accompanying manual was revised based on the ACHIEVE-Feasibility study activities, results, and clinician and participant informal feedback.
CONCLUSION


The processes for the development of a manualized intervention described here provide guidance for future researchers who aim to examine the efficacy of approaches for the treatment of hearing loss in a clinical trial. The manualized ACHIEVE-Hearing Intervention provides a patient-centered, yet standardized, step-by-step process for comprehensive audiological assessment, goal setting, and treatment through the use of hearing aids, other hearing assistive technologies, counseling, and education aimed at supporting self-management of hearing loss. The ACHIEVE-Hearing Intervention is feasible in terms of implementation with respect to verified expected outcomes, compliance, and reasonable timeframe delivery. Our processes assure intervention fidelity and quality for use in the ACHIEVE randomized controlled trial (ClinicalTrials.gov Identifier: NCT03243422).",2020,Post-intervention expected outcomes were obtained with speech-in-noise performance results demonstrating a significant improvement under the aided condition and self-reported measures showing a significant reduction in self-perceived hearing handicap.,"['Inclusion criteria were cognitively healthy adults aged 70 to 89 with symmetrical mild-to-moderately severe sensorineural hearing loss', '21 eligible participants and 9 communication partners', 'older adults', 'older adults participating in the Aging and Cognitive Health Evaluation in Elders', 'Participants were recruited from the Tampa, Florida area between May 2015 and April 2016']","['manualized best-practice hearing intervention', 'hearing intervention', 'manualized hearing intervention', 'Hearing Intervention', 'hearing aids, other hearing assistive technologies, counseling, and education aimed at supporting self-management of hearing loss']","['rates of cognitive decline', 'self-perceived hearing handicap']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0175637', 'cui_str': 'Health assessment'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0036605', 'cui_str': 'Assistive equipment'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}]","[{'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}]",21.0,0.0348221,Post-intervention expected outcomes were obtained with speech-in-noise performance results demonstrating a significant improvement under the aided condition and self-reported measures showing a significant reduction in self-perceived hearing handicap.,"[{'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Sanchez', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of South Florida, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Arnold', 'Affiliation': 'College of Math, University of South Florida-Sarasota-Manatee, USA.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Reed', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins School of Medicine, USA.'}, {'ForeName': 'Preyanca H', 'Initials': 'PH', 'LastName': 'Oree', 'Affiliation': 'Department of Communication Sciences and Disorder, University of South Florida, USA.'}, {'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Matthews', 'Affiliation': 'Charlotte Eye Ear Nose and Throat Associates, PA, North Carolina, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Clock Eddins', 'Affiliation': 'Department of Communication Sciences and Disorder, University of South Florida, USA.'}, {'ForeName': 'Frank R', 'Initials': 'FR', 'LastName': 'Lin', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Johns Hopkins School of Medicine, USA.'}, {'ForeName': 'Theresa H', 'Initials': 'TH', 'LastName': 'Chisolm', 'Affiliation': 'Department of Communication Sciences and Disorder, University of South Florida, USA.'}]",Ear and hearing,['10.1097/AUD.0000000000000858']
354,32088543,Per- and polyfluoroalkyl substances and blood pressure in pre-diabetic adults-cross-sectional and longitudinal analyses of the diabetes prevention program outcomes study.,"The relationship of plasma concentration of per- and polyfluoroalkyl substances (PFAS) with blood pressure (BP) is uncertain. This study examined cross-sectional and prospective associations of PFAS with BP and hypertension. We quantified plasma PFAS concentrations from 957 participants enrolled in the lifestyle and placebo arms of the Diabetes Prevention Program (DPP), a randomized controlled trial with approximately 15 years of follow-up. We used multivariable linear and logistic regressions to test cross-sectional associations of six PFAS, including perfluorooctanesulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorohexane sulfonic acid (PFHxS), N-ethyl-perfluorooctane sulfonamido acetic acid (EtFOSAA), N-methyl-perfluorooctane sulfonamido acetic acid (MeFOSAA), and perfluorononanoic acid (PFNA), with BP and hypertension prevalence, respectively, at baseline. We used generalized linear mixed models to estimate longitudinal associations between baseline PFAS and the rate of BP changes, and Cox-Proportional hazard models to estimate risk of developing hypertension relative to baseline PFAS. Models were adjusted for baseline age, sex, race/ethnicity, treatment arm, educational attainment, income, marital status, smoking habit, alcohol drinking, and diet. We tested for effect modification by the treatment arm and sex, and accounted for multiple comparisons using the False-Discovery Rate (FDR). PFAS concentrations and hypertension prevalence within the study population (65.3% female, 57.7% White, 65.3% aged 40-59 years) were comparable to the general U.S. population. Cross-sectionally, we found small but statistically significant associations of baseline plasma concentrations of PFOA with systolic BP (β per doubling: 1.49 mmHg, 95% CI: 0.29, 2.70); and MeFOSAA with hypertension (RR = 1.09 per doubling, 95% CI: 1.01, 1.19). Estimates were not statistically significant after FDR adjustment. Longitudinally, we observed null associations in the placebo arm, but some inverse associations of baseline PFOS and MeFOSAA with systolic BP in the lifestyle arm, perhaps due to regression toward the mean. Baseline PFAS concentrations also were not prospectively associated with hypertension risk. Overall, there were modest and mostly null associations of plasma PFAS concentrations with BP and hypertension.",2020,Baseline PFAS concentrations also were not prospectively associated with hypertension risk.,"['957 participants enrolled in the lifestyle and placebo arms of the Diabetes Prevention Program (DPP), a randomized controlled trial with approximately 15\xa0years of follow-up', 'within the study population (65.3% female, 57.7% White, 65.3% aged 40-59\xa0years']","['placebo', 'Per- and polyfluoroalkyl substances and blood pressure']","['plasma concentration of per- and polyfluoroalkyl substances (PFAS) with blood pressure (BP', 'perfluorooctanesulfonic acid (PFOS), perfluorooctanoic acid (PFOA), perfluorohexane sulfonic acid (PFHxS), N-ethyl-perfluorooctane sulfonamido acetic acid (EtFOSAA), N-methyl-perfluorooctane sulfonamido acetic acid (MeFOSAA), and perfluorononanoic acid (PFNA), with BP and hypertension prevalence', 'plasma PFAS concentrations with BP and hypertension', 'Baseline PFAS concentrations', 'baseline PFOS and MeFOSAA with systolic BP', 'False-Discovery Rate (FDR', 'PFAS concentrations and hypertension prevalence', 'baseline plasma concentrations of PFOA with systolic BP (β per doubling']","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0172926', 'cui_str': 'perfluorooctanesulfonic acid'}, {'cui': 'C0070403', 'cui_str': 'perfluorooctanoic acid'}, {'cui': 'C1176320', 'cui_str': 'perflexane'}, {'cui': 'C0038762', 'cui_str': 'Sulfonic Acids'}, {'cui': 'C0166273', 'cui_str': 'perfluorooctane'}, {'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}, {'cui': 'C3712911', 'cui_str': 'Nonanoic acid, 2,2,3,3,4,4,5,5,6,6,7,7,8,8,9,9,9-heptadecafluoro-'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}]",957.0,0.0700998,Baseline PFAS concentrations also were not prospectively associated with hypertension risk.,"[{'ForeName': 'Pi-I D', 'Initials': 'PD', 'LastName': 'Lin', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA. Electronic address: p_lin@harvardpilgrim.org.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Cardenas', 'Affiliation': 'Division of Environmental Health Sciences, School of Public Health, University of California, Berkeley, Berkeley, CA, USA. Electronic address: andres.cardenas@berkeley.edu.'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Hauser', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA. Electronic address: rhauser@hsph.harvard.edu.'}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Gold', 'Affiliation': ""Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital, Boston, MA, USA. Electronic address: redrg@channing.harvard.edu.""}, {'ForeName': 'Ken P', 'Initials': 'KP', 'LastName': 'Kleinman', 'Affiliation': 'Department of Biostatistics, School of Public Health and Human Sciences, University of Massachusetts Amherst, Amherst, MA, USA.'}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Hivert', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA; Diabetes Unit, Massachusetts General Hospital, Boston, MA, USA. Electronic address: mhivert@partners.org.'}, {'ForeName': 'Antonia M', 'Initials': 'AM', 'LastName': 'Calafat', 'Affiliation': 'Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: aic7@cdc.gov.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Webster', 'Affiliation': 'Department of Environmental Health, Boston University School of Public Health, Boston, MA, USA. Electronic address: twebster@bu.edu.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA, USA. Electronic address: edward.horton@joslin.harvard.edu.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Oken', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA. Electronic address: emily_oken@harvardpilgrim.org.'}]",Environment international,['10.1016/j.envint.2020.105573']
355,31277077,Cardiorespiratory behavior of preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation: randomized crossover study.,"BACKGROUND


Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC) are modes of non-invasive respiratory support commonly used after extubation in extremely preterm infants. However, the cardiorespiratory physiology of these infants on each mode is unknown.
METHODS


Prospective, randomized crossover study in infants with birth weight ≤1250 g undergoing their first extubation attempt. NCPAP and HFNC were applied randomly for 45 min each, while ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ) were recorded. Respiratory signals were analyzed using an automated method, and differences between NCPAP and HFNC features and changes in FiO 2  were analyzed.
RESULTS


A total of 30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930 g [780, 1090] were studied. Infants were extubated at 5 days [2, 13] of life with 973 g [880, 1170] and three failed (10%). No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
CONCLUSIONS


In extremely preterm infants studied shortly after extubation, the use of HFNC was associated with longer respiratory pauses and higher FiO 2  requirements.",2020,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","['extremely preterm infants', 'infants with birth weight ≤1250', 'preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation', '30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930\u2009g [780, 1090']","['HFNC', 'NCPAP and HFNC', 'Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC']","['longer respiratory pauses', 'ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ', 'cardiorespiratory behavior']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0222762', 'cui_str': 'Thoracic Cage'}, {'cui': 'C1286159', 'cui_str': 'Movement of abdomen'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",30.0,0.118465,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2  levels (p = 0.02) during HFNC compared to NCPAP.
","[{'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'Kanbar', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Shalish', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Latremouille', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kearney', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': ""Sant'Anna"", 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada. guilherme.santanna@mcgill.ca.'}]",Pediatric research,['10.1038/s41390-019-0494-5']
356,31379101,Pharmacokinetics and Bioequivalence Studies of Teriflunomide in Healthy Iranian Volunteers.,"Multiple sclerosis, which is characterized by inflammation and neurodegeneration, is considered a chronic disease of the central nervous system. Given the lack of pharmacokinetic evaluation of teriflunomide in the Iranian context, the present 2-way crossover study aimed to assess the pharmacokinetic properties and bioequivalence of 2 teriflunomide formulations. To this end, 2 single-dose generic and branded teriflunomide formulations were orally administered to 14 healthy Iranian male volunteers. A washout period of 21 days was allowed between the treatments. The plasma samples containing teriflunomide were analyzed by a simple and sensitive high-performance liquid chromatography method using standard ultraviolet detection. In addition, the pharmacokinetic parameters were calculated for bioequivalence evaluation. The peak area ratio between the teriflunomide and the internal standard was the source of calibration curves, which were linear over the range of 20-40,000 ng/mL (R 2  = 0.9994). The results indicated that the 2 formulations had similar pharmacokinetics. Further, the 90%CI of the mean ratios of the test versus the reference formulations of log-transformed area under the concentration-time curve over 72 hours (93% to 107%) and peak concentration (92% to 108%) were within the acceptable range of 80% to 125%. Based on the obtained results, the test formulation of teriflunomide could be similar to that of the reference formulation.",2020,The plasma samples containing teriflunomide were analyzed by a simple and sensitive high-performance liquid chromatography method using standard ultraviolet detection.,"['14 healthy Iranian male volunteers', 'Healthy Iranian Volunteers']",['Teriflunomide'],"['concentration-time curve', 'peak concentration', 'peak area ratio']","[{'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C1718383', 'cui_str': 'teriflunomide'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",14.0,0.0324199,The plasma samples containing teriflunomide were analyzed by a simple and sensitive high-performance liquid chromatography method using standard ultraviolet detection.,"[{'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Rouini', 'Affiliation': 'Biopharmaceutics and Pharmacokinetic Division, Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Dibaei', 'Affiliation': 'Biopharmaceutics and Pharmacokinetic Division, Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Ghasemian', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.725']
357,30484332,Impact of Combination of Local Anesthetic Wounds Infiltration and Ultrasound Transversus Abdominal Plane Block in Patients Undergoing Robot-Assisted Radical Prostatectomy: Perioperative Results of a Double-Blind Randomized Controlled Trial.,"OBJECTIVE


To determinate benefits of the combination of local anesthetic wounds infiltration and ultrasound transversus abdominal plane (US-TAP) block with ropivacaine on postoperative pain, early recovery, and hospital stay in patients undergoing robot-assisted radical prostatectomy (RARP).
METHODS


The study is double-blinded randomized controlled trial. Our hypothesis was that the combination of wound infiltration and US-TAP block with ropivacaine would decrease immediate postoperative pain and opioids use. Primary outcomes included postoperative pain and opioids demand during the hospital stay. Secondary outcomes were nausea/vomiting rate, stool passing time, use of prokinetics, length of hospital stay (LOS), and 30-days readmission to the hospital for pain or other US-TAP block-related complications.
RESULTS


A total of 100 patients who underwent RARP were eligible for the analysis; 57 received the US-TAP block with 20 mL of 0.35% ropivacaine (US-TAP block group) and 43 did not receive US-TAP block (no-US-TAP group). All the patients received the local wound anesthetic infiltration with 20 mL of 0.35% ropivacaine. US-TAP block group showed a decreased mean Numerical Rating Scale (NRS) within 12 hours after surgery (1.6 vs 2.6; p = 0.02) and mean NRS (1.8 vs 2.7; p = 0.04) with lesser number of patients who used opioid (3.5% vs 18.6%; p = 0.01) during the first 24 hours. Moreover, we found a shorter mean LOS (4.27 vs 4.72, days; p = 0.04) with a lower requirement of prokinetics administration during the hospital stay (21% vs 72%; p < 0.001). No US-TAP block-related complications were reported.
CONCLUSION


Combination of anesthetic wound infiltration and US-TAP block with ropivacaine as part of a multimodal analgesic regimen can be safely offered to patients undergoing RARP and extended pelvic lymph node dissection. It improves the immediate postoperative pain control, reducing opioids administration and is associated to a decreased use of prokinetics and shorter hospital stay.",2019,"No US-TAP block-related complications were reported.
","['patients undergoing RARP and extended pelvic lymph node dissection', 'patients undergoing robot-assisted radical prostatectomy (RARP', '100 patients who underwent RARP were eligible for the analysis; 57 received the', 'Patients Undergoing Robot-Assisted Radical Prostatectomy']","['local anesthetic wounds infiltration and ultrasound transversus abdominal plane (US-TAP) block with ropivacaine', 'ropivacaine', 'US-TAP block with 20\u2009mL of 0.35% ropivacaine (US-TAP block group) and 43 did not receive US-TAP block', 'Local Anesthetic Wounds Infiltration and Ultrasound Transversus Abdominal Plane Block']","['postoperative pain, early recovery, and hospital stay', 'postoperative pain and opioids demand during the hospital stay', 'mean NRS', 'mean Numerical Rating Scale (NRS', 'nausea/vomiting rate, stool passing time, use of prokinetics, length of hospital stay (LOS), and 30-days readmission to the hospital for pain or other US-TAP block-related complications', 'shorter mean LOS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node structure (body structure)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration (procedure)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517451', 'cui_str': 'Zero point three five'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",100.0,0.134726,"No US-TAP block-related complications were reported.
","[{'ForeName': 'Giovanni Enrico', 'Initials': 'GE', 'LastName': 'Cacciamani', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Menestrina', 'Affiliation': '2 Department of Anesthesiologist and Intensive Care University of Verona, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pirozzi', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Tafuri', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corsi', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'De Marchi', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Inverardi', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Processali', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': ""Nicolo'"", 'Initials': 'N', 'LastName': 'Trabacchin', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'De Michele', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sebben', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Maria Angela', 'Initials': 'MA', 'LastName': 'Cerruto', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'De Marco', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Migliorini', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Antonio Benito', 'Initials': 'AB', 'LastName': 'Porcaro', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Artibani', 'Affiliation': '1 Departments of Urology, Italy.'}]",Journal of endourology,['10.1089/end.2018.0761']
358,32247598,Laparoscopic-guided versus transincisional rectus sheath block for pediatric single-incision laparoscopic cholecystectomy: A randomized controlled trial.,"PURPOSE


The purpose of our study was to compare the effectiveness of transincisional (TI) versus laparoscopic-guided (LG) rectus sheath block (RSB) for pain control following pediatric single-incision laparoscopic cholecystectomy (SILC).
METHODS


Forty-eight patients 10-21 years old presenting to a single institution for SILC from 2015 to 2018 were randomized to TI or LG RSB. Apart from RSB technique, perioperative care protocols were identical between groups. Pain scores were assessed with validated measures upon arrival in the postanesthesia care unit (PACU) and at regular intervals until discharge. The patients and those assessing them were blinded to RSB technique. The primary outcome was pain score 60 min after PACU arrival. Secondary outcomes included pain scores throughout the PACU stay, opioids (reported as morphine milligram equivalents (MME) per kg bodyweight) administered in PACU, length of stay, outpatient pain scores and opioid use, and adverse events. Groups were compared on outcomes using t test and generalized estimating equations for continuous variables and Fisher's exact test for categorical variables with significance at α = 0.05.
RESULTS


Mean age of the 48 subjects was 15 years (range = 11-20). The majority (79%) were female. Indications for surgery included symptomatic cholelithiasis (n = 41), acute cholecystitis (n = 4), gallstone pancreatitis (n = 2) and choledocholithiasis (n = 1). Mean (standard deviation) operative time was 61 (±23) min overall. No statistically significant differences in demographics, indication, operative time, or intraoperative analgesia were observed between TI (n = 24) and LG (n = 24) groups. The mean 60-min pain score was 3.4 (±2.6) in the LG group versus 3.8 (±2.1) in the TI group (p = 0.573). No significant differences were detected between groups in overall PACU or outpatient pain scores, PACU or outpatient opioid use, length of stay, or incidence of complications. Overall, mean opioid use was 0.1 MME/kg in the PACU and 0.5 MME/kg in the outpatient setting. Mean postoperative length of stay was 0.2 day. There were no major complications.
CONCLUSION


Laparoscopic-guided rectus sheath block is not superior to transincisional rectus sheath block for pain control following pediatric single-incision laparoscopic cholecystectomy. The single-incision laparoscopic approach combined with rectus sheath block resulted in effective pain control, low opioid use, and expedited length of stay with no major complications.
LEVEL OF EVIDENCE


Level I, treatment study, randomized controlled trial.",2020,"No significant differences were detected between groups in overall PACU or outpatient pain scores, PACU or outpatient opioid use, length of stay, or incidence of complications.","['surgery included symptomatic cholelithiasis (n\u202f=\u202f41), acute cholecystitis (n\u202f=\u202f4), gallstone pancreatitis (n\u202f=\u202f2) and choledocholithiasis (n\u202f=\u202f1', '10-21\u202fyears old presenting to a single institution for SILC from 2015 to 2018 were randomized to', 'pain control following pediatric single-incision laparoscopic cholecystectomy (SILC', 'Forty-eight patients', 'Mean age of the 48 subjects was 15\u202fyears (range\u202f=\u202f11-20']","['TI or LG RSB', 'pediatric single-incision laparoscopic cholecystectomy', 'rectus sheath block', 'Laparoscopic-guided versus transincisional rectus sheath block', 'transincisional (TI) versus laparoscopic-guided (LG) rectus sheath block (RSB', 'Laparoscopic-guided rectus sheath block']","['pain scores throughout the PACU stay, opioids (reported as morphine milligram equivalents (MME) per kg bodyweight) administered in PACU, length of stay, outpatient pain scores and opioid use, and adverse events', 'pain score 60\u202fmin after PACU arrival', 'Pain scores', 'Mean postoperative length of stay', 'overall PACU or outpatient pain scores, PACU or outpatient opioid use, length of stay, or incidence of complications', 'effective pain control, low opioid use, and expedited length of stay with no major complications', 'Mean (standard deviation) operative time', 'demographics, indication, operative time, or intraoperative analgesia', 'mean 60-min pain score']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0008350', 'cui_str': 'Biliary calculus'}, {'cui': 'C0149520', 'cui_str': 'Acute cholecystitis'}, {'cui': 'C0521614', 'cui_str': 'Gallstone pancreatitis'}, {'cui': 'C0701818', 'cui_str': 'Cholelithiasis, Common Bile Duct'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]",,0.177008,"No significant differences were detected between groups in overall PACU or outpatient pain scores, PACU or outpatient opioid use, length of stay, or incidence of complications.","[{'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Kauffman', 'Affiliation': ""Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: jkauff10@jhu.edu.""}, {'ForeName': 'Anh Thy H', 'Initials': 'ATH', 'LastName': 'Nguyen', 'Affiliation': ""Department of Health Informatics, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: anguye57@jhmi.edu.""}, {'ForeName': 'Cristen N', 'Initials': 'CN', 'LastName': 'Litz', 'Affiliation': ""Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: clitz@health.usf.edu.""}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Farach', 'Affiliation': ""Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: sandrafarach@gmail.com.""}, {'ForeName': 'JoAnn C', 'Initials': 'JC', 'LastName': 'DeRosa', 'Affiliation': ""Clinical and Translational Research Organization, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: joann.derosa@jhmi.edu.""}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Gonzalez', 'Affiliation': ""Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: rgonza35@jhmi.edu.""}, {'ForeName': 'Ernest K', 'Initials': 'EK', 'LastName': 'Amankwah', 'Affiliation': ""Department of Health Informatics, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: ernest.amankwah@jhmi.edu.""}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Danielson', 'Affiliation': ""Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: paul.danielson@jhmi.edu.""}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Chandler', 'Affiliation': ""Division of Pediatric Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA. Electronic address: nicole.chandler@jhmi.edu.""}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2020.03.002']
359,32007430,The Role of the Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Radical Prostatectomy: A Randomized Clinical Trial.,"BACKGROUND


Erectile dysfunction (ED) after radical prostatectomy (RP) still represents a major issue. Considering the benefits recently described regarding the application of low-intensity extracorporeal shockwave therapy (LiESWT) in vasculogenic ED, questions arise about its role in the scenario of penile rehabilitation.
AIM


To compare the early introduction of phosphodiesterase-5 inhibitor (PDE5i) with a combination therapy enrolling both early PDE5i use and LiESWT in patients submitted to RP.
METHODS


This study is a randomized clinical trial, open-label, with 2 parallel arms and an allocation ratio of 1:1. The study was registered in ReBEC (ensaiosclinicos.gov.br) Trial: RBR-85HGCG. Both arms started tadalafil at a dose of 5 mg/day right after the removal of the transurethral catheter, and the experimental group received 2,400 shocks/session-week distributed on 4 different penile regions. The full treatment consisted of 19,200 impulses across 8 weeks.
OUTCOMES


The primary clincal end point was ≥4-point difference favoring the experimental group considering the mean International Index of Erectile Function short form (IIEF-5) at last follow-up. Any statistical difference in the IIEF-5 score between the arms was stated as the primary statistical end point.
RESULTS


Between September 25, 2017, and December 3, 2018, 92 men were enrolled in the study. At last follow-up, we assessed 77 patients, 41 in the control group and 36 in the intervention group. A difference between groups was detected when accessing the final median IIEF-5 score (12.0 vs 10.0; P = .006). However, the primary clinical endpoint considering a difference ≥4-point between the arms has not been reached. When performing an exploratory analysis comparing the proportion of those individuals with an IIEF-5 score ≥17, no difference between groups was noted (17.1% vs 22.2%; P = .57).
CLINICAL IMPLICATIONS


So far, the benefits arising from LiESWT for penile rehabilitation after RP have been uncertain.
STRENGTHS & LIMITATIONS


This is the first trial assessing the role of LiESWT on erectile function after RP. Our study protocol included only one session per week for the experimental group, raising a query if a more intensive application could achieve better results once a statistically significant difference was found between groups. We discontinue the PDE5i use at the last session, which may have interfered in the penile vascular rehabilitation, maybe compromising the results too.
CONCLUSION


After therapy with 19,200 impulses therapy across 8 weeks, we found an improvement of the IIEF-5 score, but it was not enough to be considered clinically significant. More studies are warranted before any recommendation on this topic. Baccaglini W, Pazeto CL, Corrêa Barros EA, et al. The Role of the Low-Intensity Extracorporeal Shockwave Therapy on Penile Rehabilitation After Radical Prostatectomy: A Randomized Clinical Trial. J Sex Med 2020;17:688-694.",2020,The primary clincal end point was ≥4-point difference favoring the experimental group considering the mean International Index of Erectile Function short form (IIEF-5) at last follow-up.,"['77 patients, 41 in the control group and 36 in the intervention group', 'patients submitted to RP', '92 men were enrolled in the study', 'Between September 25, 2017, and December 3, 2018']","['radical prostatectomy (RP', 'phosphodiesterase-5 inhibitor (PDE5i', 'low-intensity extracorporeal shockwave therapy (LiESWT', 'LiESWT', 'Low-Intensity Extracorporeal Shockwave Therapy', 'tadalafil']","['final median IIEF-5 score', 'mean\xa0International Index of Erectile Function short form (IIEF-5', 'IIEF-5 score', 'Penile Rehabilitation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C1318700', 'cui_str': 'PDE5 Inhibitors'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]",92.0,0.0809134,The primary clincal end point was ≥4-point difference favoring the experimental group considering the mean International Index of Erectile Function short form (IIEF-5) at last follow-up.,"[{'ForeName': 'Willy', 'Initials': 'W', 'LastName': 'Baccaglini', 'Affiliation': 'Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil. Electronic address: wbaccaglini@gmail.com.'}, {'ForeName': 'Cristiano Linck', 'Initials': 'CL', 'LastName': 'Pazeto', 'Affiliation': 'Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil.'}, {'ForeName': 'Eduardo Augusto', 'Initials': 'EA', 'LastName': 'Corrêa Barros', 'Affiliation': 'Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil.'}, {'ForeName': 'Frederico', 'Initials': 'F', 'LastName': 'Timóteo', 'Affiliation': 'Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Monteiro', 'Affiliation': 'Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil.'}, {'ForeName': 'Raiff Yusser', 'Initials': 'RY', 'LastName': 'Saad Rached', 'Affiliation': 'Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Navas', 'Affiliation': 'Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Glina', 'Affiliation': 'Discipline of Urology, Faculdade de Medicina do ABC, Santo André, Brazil.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.12.024']
360,32147519,Radiation-Induced Lymphopenia Predicts Poorer Prognosis in Patients With Breast Cancer: A Post Hoc Analysis of a Randomized Controlled Trial of Postmastectomy Hypofractionated Radiation Therapy.,"PURPOSE


The aim of this study was to determine whether radiation-induced lymphopenia affects the survival of patients with breast cancer.
METHODS AND MATERIALS


Post hoc analysis was conducted on data from 598 patients with breast cancer from a randomized controlled trial comparing postmastectomy hypofractionated radiation therapy (HFRT; 43.5 Gy in 15 fractions over 3 weeks) with conventional fractionated radiation therapy (CFRT; 50 Gy in 25 fractions over 5 weeks). Mean peripheral lymphocyte count (PLC) at different time points in the 2 groups was compared by the t test. Disease-free survival and overall survival were analyzed by the Kaplan-Meier method and compared between groups by the log-rank test.
RESULTS


Baseline PLC (pre-PLC) was comparable between HFRT and CFRT patients (1.60 ± 0.57 × 10 9 /L vs 1.56 ± 0.52 × 10 9 /L; P = .33). In both groups, the PLC declined steadily during the course of radiation therapy but started to recover at 1 month after radiation therapy. Incidence of lymphopenia was significantly lower in HFRT patients (45.4% vs 55.7%; P = .01). Nadir-PLC was significantly higher in HFRT patients (1.08 ± 0.37 × 10 9 /L vs 0.97 ± 0.31× 10 9 /L; P < .001), as was the nadir-PLC/pre-PLC ratio (0.72 ± 0.28 vs 0.67 ± 0.28; P = .02). Median follow-up was 57.6 months (interquartile range, 38.5-81.4). The 5-year disease-free survival was significantly lower in patients with a nadir-PLC/pre-PLC ratio <0.8 than in those with a ratio ≥0.8 (71.8% vs 82.6%; P = .01); however, overall survival was comparable between the groups (85.8% vs 90.6%; P = .24).
CONCLUSIONS


The risk of radiation-induced lymphopenia in patients with breast cancer is lower with HFRT than with CFRT. A low nadir-PLC/pre-PLC ratio may predict poor prognosis.",2020,Incidence of lymphopenia was significantly lower in HFRT patients (45.4% vs. 55.7%; P = .01).,"['Patients with Breast Cancer', '598 breast cancer patients', 'patients with breast cancer', 'breast cancer patients']","['CFRT', 'postmastectomy hypofractionated radiotherapy (HFRT; 43.5 Gy in 15 fractions over 3 weeks) with conventional fractionated radiotherapy (CFRT', 'radiation-induced lymphopenia (RIL', 'HFRT', 'radiotherapy', 'Radiation-Induced Lymphopenia', 'Postmastectomy Hypofractionated Radiotherapy']","['risk of RIL', 'Disease-free survival (DFS) and overall survival (OS', 'Mean peripheral lymphocyte count (PLC', '5-year DFS', 'OS', 'Incidence of lymphopenia', 'Nadir PLC (nadir-PLC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}]",598.0,0.104652,Incidence of lymphopenia was significantly lower in HFRT patients (45.4% vs. 55.7%; P = .01).,"[{'ForeName': 'Guang-Yi', 'Initials': 'GY', 'LastName': 'Sun', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shu-Lian', 'Initials': 'SL', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: wsl20040118@yahoo.com.'}, {'ForeName': 'Yong-Wen', 'Initials': 'YW', 'LastName': 'Song', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wei-Hu', 'Initials': 'WH', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yue-Ping', 'Initials': 'YP', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xu-Ran', 'Initials': 'XR', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yu-Chun', 'Initials': 'YC', 'LastName': 'Song', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Zi-Hao', 'Initials': 'ZH', 'LastName': 'Yu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xin-Fan', 'Initials': 'XF', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Ye-Xiong', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: yexiong@yahoo.com.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.02.633']
361,31837291,Increasing long-acting reversible contraceptives: the Australian Contraceptive ChOice pRoject (ACCORd) cluster randomized trial.,"BACKGROUND


Long-active reversible contraceptives reduce unintended pregnancy and abortions, but uptake is low. Interventions to increase uptake in family medicine settings are untested.
OBJECTIVE


The Australian Contraceptive ChOice pRoject, which was adapted from the successful US Contraceptive CHOICE study, aimed to evaluate whether a complex intervention in family medicine practices resulted in increased long-active reversible contraceptive uptake.
STUDY DESIGN


This cluster randomized controlled trial was set in family practices in metropolitan Melbourne, Australia. From April 2016 to January 2017, we recruited 57 family physicians by mail invitation. Each family physician aimed to recruit at least 14 female patients. Eligible family physicians worked ≥3 sessions per week in computerized practices. Eligible women were English-speaking, sexually active, not pregnant, not planning a pregnancy in the next year, 16-45 years old, and interested in discussing contraception or in starting a new, reversible method. With the use of a randomization sequence with permuted blocks that were stratified by whether the family physician performed long-active reversible contraceptive insertion or not, family physicians were assigned randomly to a complex intervention that involved training to provide structured effectiveness-based contraceptive counselling and access to rapid referral to long-active reversible contraceptive insertion clinics. The 6-hour, online educational intervention was based on the US Contraceptive CHOICE Project and adapted for the Australian context. The control family physicians received neither the educational intervention nor access to the long-active reversible contraceptive rapid referral clinics and conducted their usual contraception counselling. We used the chi-square test, which was adjusted for clustering and stratification by whether the family physician inserted long-active reversible contraceptives, and binary regression models with generalized estimating equations and robust standard errors to compare, between the intervention and control groups, the proportions of women who had a long-active reversible contraceptive inserted. The primary outcome was the proportion of women with long-active reversible contraceptives that were inserted at 4 weeks. Secondary outcomes included women's choice of contraceptive method, quality of life, and long-active reversible contraceptive use at 6 and 12 months. Analyses were performed according to intention-to-treat.
RESULTS


A total of 25 intervention and 32 control family physicians recruited 307 and 433 women, respectively (N=740). Within 4 weeks, 19.3% of women in the intervention group and 12.9% of women in the control group had long-active reversible contraceptive inserted (relative risk, 2.0; 95% confidence interval, 1.1-3.9; P=.033). By 6 months, this number had risen to 44.4% and 29.3%, respectively (relative risk, 1.6; 95% confidence interval, 1.2-2.17; P=.001); by 12 months, it had risen to 46.6% and 32.8%, respectively (relative risk, 1.5; 95% confidence interval, 1.2-2.0; P=.0015). The levonorgestrel intrauterine system was the most commonly chosen long-active reversible contraceptive by women in the intervention group at all time points. Differences between intervention and control groups in mean quality-of-life scores across all domains at 6 and 12 months were small.
CONCLUSION


A complex intervention combination of family physician training on contraceptive effectiveness counselling and rapid access to long-active reversible contraceptive insertion clinics resulted in greater long-active reversible contraceptive uptake and has the potential to reduce unintended pregnancies.",2020,The levonorgestrel intra-uterine system was the most commonly chosen LARC by women in the intervention group at all time points.,"['Eligible women were English speaking, sexually active, not pregnant, not planning a pregnancy in the following year, aged 16-45 years and interested in discussing contraception or in starting a new, reversible method', 'From April 2016 to January 2017 we recruited 57 family physicians by mail invitation', '14 women patients', 'A total of 25 intervention and 32 control family physicians recruited 307 and 433 women respectively (N=740', 'family practices in metropolitan Melbourne, Australia']","['educational intervention nor access to the LARC rapid referral clinics and conducted their usual contraception counselling', 'Long-active reversible contraceptives (LARCs', 'complex intervention involving training to provide structured effectiveness-based contraceptive counselling, and access to rapid referral to LARC insertion clinics']","[""women's choice of contraceptive method, quality of life (QOL) and LARC use"", 'LARC', 'proportion of women with LARCs', 'mean QOL scores', 'LARC uptake']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant (finding)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0543488', 'cui_str': 'Interested (finding)'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1704221', 'cui_str': 'Physicians, Family'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1443484', 'cui_str': 'Contraception care education (procedure)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0034380'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",433.0,0.307268,The levonorgestrel intra-uterine system was the most commonly chosen LARC by women in the intervention group at all time points.,"[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Mazza', 'Affiliation': 'Department of General Practice, Monash University, Melbourne, Australia; School of Primary Health Care, Monash University, Melbourne, Australia. Electronic address: Danielle.Mazza@monash.edu.'}, {'ForeName': 'Cathy J', 'Initials': 'CJ', 'LastName': 'Watson', 'Affiliation': 'Department of General Practice, Monash University, Melbourne, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Taft', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Lucke', 'Affiliation': 'School of Psychology and Public Health, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McGeechan', 'Affiliation': 'University of Sydney, School of Public Health, and the University of Technology, Centre for Health Economics Research and Evaluation, Sydney, Australia.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Haas', 'Affiliation': 'University of Sydney, School of Public Health, and the University of Technology, Centre for Health Economics Research and Evaluation, Sydney, Australia.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'McNamee', 'Affiliation': 'Family Planning Victoria, Melbourne, Australia.'}, {'ForeName': 'Jeffrey F', 'Initials': 'JF', 'LastName': 'Peipert', 'Affiliation': 'Department of Obstetrics & Gynecology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Kirsten I', 'Initials': 'KI', 'LastName': 'Black', 'Affiliation': 'Royal Prince Alfred Hospital, the University of Sydney, Sydney, Australia.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.11.1267']
362,31698085,Centralized Reminder/Recall to Increase Influenza Vaccination Rates: A Two-State Pragmatic Randomized Trial.,"OBJECTIVE


Centralized reminder/recall (C-R/R) by health departments using immunization information systems is more effective and cost effective than practice-based approaches for increasing childhood vaccines but has not been studied for influenza vaccination. We assessed effectiveness and cost of C-R/R for increasing childhood influenza vaccination compared with usual care.
METHODS


Within Colorado (CO) and New York (NY), random samples of primary care practices (pediatric, family medicine, and health center) were selected proportionate to where children are served-65 practices (N = 54,353 children) in CO; 101 practices (N = 65,777) in NY. We conducted 4-arm RCTs per state (1, 2, or 3 autodial reminders vs usual care), with randomization at the patient level within practices from 10/2016 to 1/2017.
RESULTS


In CO, the maximum absolute difference in receipt of ≥1 influenza vaccine was 1.7% between the 2 R/R group and control (adjusted risk ratio [ARR] of 1.06 [1.01, 1.10]); other R/R arms did not differ significantly. In NY, ARRs for the study arms versus control varied from 1.05 (1.01, 1.10) for 3 R/R to 1.06 (1.01, 1.11) for 1-2 R/R groups and maximum absolute increase in vaccination was 0.6%. In time-to-event analyses, study arm was a significant predictor of vaccination in CO (P = .001) but not in NY. Costs/child randomized to one message were $.17 in CO and $.23 in NY.
CONCLUSIONS


C-R/R for influenza vaccine using autodial had low-level effects on increasing influenza rates in 2 states. Given the feasibility and low cost of C-R/R in previous trials, its utility for influenza should be re-examined using different modalities.",2020,"In time-to-event analyses, study arm was a significant predictor of vaccination in CO (p=.001) but not in NY.","['65 practices (N=54,353 children) in CO; 101 practices (N=65,777) in NY', 'Within Colorado (CO) and New York (NY), random samples of primary care practices (pediatric, family medicine, health center) were selected proportionate to where children are']",['served'],"['Influenza Vaccination Rates', 'receipt of ≥1 influenza vaccine', 'influenza rates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0015607', 'cui_str': 'Family Practice'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0205351', 'cui_str': 'Proportional (qualifier value)'}]",[],"[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}]",,0.103594,"In time-to-event analyses, study arm was a significant predictor of vaccination in CO (p=.001) but not in NY.","[{'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kempe', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado (A Kempe, AW Saville, L Helmkamp, LM Dickinson, and D Gurfinkel), Aurora, Colo; Department of Pediatrics, University of Colorado School of Medicine (A Kempe), Aurora, Colo. Electronic address: allison.kempe@childrenscolorado.org.""}, {'ForeName': 'Alison W', 'Initials': 'AW', 'LastName': 'Saville', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado (A Kempe, AW Saville, L Helmkamp, LM Dickinson, and D Gurfinkel), Aurora, Colo.""}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Albertin', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles (C Albertin and P Szilagyi), Los Angeles, Calif.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Helmkamp', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado (A Kempe, AW Saville, L Helmkamp, LM Dickinson, and D Gurfinkel), Aurora, Colo.""}, {'ForeName': 'Xinkai', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California (X Zhou, S Vangela, and C-H Tseng), Los Angeles, Calif.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Vangela', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California (X Zhou, S Vangela, and C-H Tseng), Los Angeles, Calif.'}, {'ForeName': 'L Miriam', 'Initials': 'LM', 'LastName': 'Dickinson', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado (A Kempe, AW Saville, L Helmkamp, LM Dickinson, and D Gurfinkel), Aurora, Colo; Department of Family Medicine, University of Colorado School of Medicine (LM Dickinson), Aurora, Colo.""}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California (X Zhou, S Vangela, and C-H Tseng), Los Angeles, Calif.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Campbell', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus (JD Campbell and M Whittington), Aurora, Colo.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Whittington', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus (JD Campbell and M Whittington), Aurora, Colo.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Gurfinkel', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado (A Kempe, AW Saville, L Helmkamp, LM Dickinson, and D Gurfinkel), Aurora, Colo.""}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Roth', 'Affiliation': 'Colorado Immunization Information System, Colorado Department of Public Health and Environment (H Roth), Denver, Colo.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Hoefer', 'Affiliation': 'New York State Immunization Information System, New York State Department of Health (D Hoefer), Albany, NY.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Szilagyi', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles (C Albertin and P Szilagyi), Los Angeles, Calif.""}]",Academic pediatrics,['10.1016/j.acap.2019.10.015']
363,32179258,Quantitative flow ratio-guided strategy versus angiography-guided strategy for percutaneous coronary intervention: Rationale and design of the FAVOR III China trial.,"BACKGROUND


Quantitative flow ratio (QFR) is a novel angiography-based approach enabling fast computation of fractional flow reserve without use of pressure wire or adenosine. The objective of this investigator-initiated, multicenter, patient- and clinical assessor-blinded randomized trial is to evaluate the efficacy and cost-effectiveness of a QFR-augmented angiography-guided (QFR-guided) strategy versus an angiography-only guided (angiography-guided) strategy for percutaneous coronary intervention (PCI) in patients with coronary artery disease.
METHODS


Approximately 3,830 patients will be randomized in a 1:1 ratio to a QFR-guided or an angiography-guided strategy. Included subjects scheduled for coronary angiography have at least 1 lesion eligible for PCI with 50%-90% stenosis in an artery with ≥2.5 mm reference diameter. Subjects assigned to the QFR-guided strategy will have QFR measured in each interrogated vessel and undergo PCI when QFR ≤0.80, with deferral for lesions with QFR >0.80. Those assigned to the angiography-guided strategy will undergo PCI based on angiography. Optimal medical therapy will be administered to all treated and deferred patients. The primary end point is the 1-year rate of major adverse cardiac events (MACE), a composite of all-cause mortality, any myocardial infarction, or any ischemia-driven revascularization. The major secondary end point is 1-year MACE excluding periprocedural myocardial infarction. Other secondary end points include the individual components of MACE and cost-effectiveness end points. The sample size affords 85% power to demonstrate superiority of QFR guidance compared with angiography guidance.
CONCLUSIONS


The FAVOR III China study will be the first randomized trial to examine the effectiveness and cost-effectiveness of a QFR-guided versus an angiography-guided PCI strategy in coronary artery disease patients.",2020,"The sample size affords 85% power to demonstrate superiority of QFR guidance compared with angiography guidance.
","['Included subjects scheduled for coronary angiography have at least 1 lesion eligible for PCI with 50%-90% stenosis in an artery with ≥2.5 mm reference diameter', 'Approximately 3,830 patients', 'coronary artery disease patients', 'patients with coronary artery disease']","['Quantitative flow ratio-guided strategy versus angiography-guided strategy', 'angiography-guided strategy will undergo PCI based on angiography', 'QFR-guided versus an angiography-guided PCI strategy', 'QFR-guided or an angiography-guided strategy', 'Quantitative flow ratio (QFR', 'percutaneous coronary intervention (PCI', 'QFR-augmented angiography-guided (QFR-guided) strategy versus an angiography-only guided (angiography-guided) strategy']","['efficacy and cost-effectiveness', 'individual components of MACE and cost-effectiveness end points', '1-year rate of major adverse cardiac events (MACE), a composite of all-cause mortality, any myocardial infarction, or any ischemia-driven revascularization', '1-year MACE excluding periprocedural myocardial infarction']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4324584', 'cui_str': 'Periprocedural myocardial infarction'}]",3830.0,0.0747895,"The sample size affords 85% power to demonstrate superiority of QFR guidance compared with angiography guidance.
","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Shengxian', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Medical Research and Biometrics Center, National Center for Cardiovascular Diseases, Beijing, China.'}, {'ForeName': 'Daixin', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': 'Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Changdong', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clinico San Carlos, Madrid, Spain.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Fearon', 'Affiliation': 'Division of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': 'New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; Cardiovascular Research Foundation, New York, NY.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wijns', 'Affiliation': 'The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY; Cardiovascular Research Foundation, New York, NY.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Cardiovascular Research Foundation, New York, NY; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Shubin', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. Electronic address: qsbfw@sina.com.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China; National Clinical Research Center for Cardiovascular Diseases, Beijing, China. Electronic address: bxu@citmd.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.02.015']
364,32059936,"The Effect of Transendocardial Stem Cell Injection on Erectile Function in Men With Cardiomyopathy: Results From the TRIDENT, POSEIDON, and TAC-HFT Trials.","BACKGROUND


Despite limited human data, there is a growing interest in the use of stem cell therapy (SCT) for erectile dysfunction (ED).
AIM


To determine the effect of transendocardial stem cell injection on erectile function on men with cardiomyopathy and ED.
METHODS


We used International Index of Erectile Function (IIEF) scores collected from men enrolled in 3 separate randomized controlled trials: Comparison of Allogeneic vs Autologous Bone Marrow-Derived Mesenchymal Stem Cells Delivered by Transendocardial Injection in Patients With Ischemic Cardiomyopathy (POSEIDON), Transendocardial Mesenchymal Stem Cells and Mononuclear Bone Marrow Cells for Ischemic Cardiomyopathy (TAC-HFT), and Dose Comparison Study of Allogeneic Mesenchymal Stem Cells in Patients With Ischemic Cardiomyopathy (TRIDENT). These trials recruited patients with ischemic cardiomyopathy and ejection fraction less than 50%. Inclusion and exclusion criteria were identical in all 3 trials. The primary intervention in these trials included transendocardial stem cell injection of stem cells or placebo via cardiac catheterization. The follow-up period was 1 year. IIEF data were collected at baseline and at multiple time points in each trial.
OUTCOMES


We investigated erectile function over time based on cell dose, cell source (autologous vs allogenic), cell type (mesenchymal stem cells vs bone marrow mononuclear cells), and comparing men who received SCT with those who received placebo.
RESULTS


A total of 36 men were identified with complete IIEF data. 8 men received placebo injection, and 28 received SCT. The median age was 66.5 years. Comorbidities were similar among all men. Analysis was performed on men with ED, defined by an IIEF-EF score of 24 or less. In the placebo and all-comer SCT group, the median IIEF-EF score was 5 [1-8] and 5 [1-15] at baseline and was 3.5 [3-5.8] and 7 [1-18] at 12 months (P > .05). When analyzed by cell dose, the IIEF-EF score in men who received 200 million cells increased significantly over 12 months (14 [4-23] to 20 [15-24.5], P = .014.) Similarly, an autologous cell source resulted in a similar increase from baseline to 12 months (14 [3.8-23.3] to 20 [12-22], P = .030).
CLINICAL IMPLICATIONS


Erectile function may improve after systemic delivery of SCT in men with ischemic cardiomyopathy and at least mild ED.
STRENGTHS & LIMITATIONS


This post hoc analysis is the first to investigate the effect of SCT on erectile function using randomized, placebo-controlled data. Weaknesses include that ED was not a primary end point, and men were not originally recruited based on erectile function.
CONCLUSION


Future trials on systemic delivery of SCT for ED should focus on high cell dose and autologous cell source, as these seem to provide the best response in men with at least mild ED. Ory J, Saltzman RG, Blachman-Braun R, et al. The Effect of Transendocardial Stem Cell Injection on Erectile Function in Men With Cardiomyopathy: Results From the TRIDENT, POSEIDON, and TAC-HFT Trials. J Sex Med 2020;17:695-701.",2020,"When analyzed by cell dose, the IIEF-EF score in men who received 200 million cells increased significantly over 12 months (14 [4-23] to 20 [15-24.5], P = .014.)","['men with cardiomyopathy and ED', 'Patients', 'men with at least mild ED', 'men with ischemic cardiomyopathy and at least mild ED', 'Men With Cardiomyopathy', 'patients with ischemic cardiomyopathy and ejection fraction less than 50', 'A total of 36 men were identified with complete IIEF data']","['transendocardial stem cell injection of stem cells or placebo via cardiac catheterization', 'transendocardial stem cell injection', 'stem cell therapy (SCT', 'SCT', 'Transendocardial Stem Cell Injection', 'placebo', 'Allogeneic vs Autologous Bone Marrow-Derived Mesenchymal Stem Cells Delivered by Transendocardial Injection', 'Allogeneic Mesenchymal Stem Cells', 'cell source (autologous vs allogenic), cell type (mesenchymal stem cells vs bone marrow mononuclear cells', 'placebo injection', 'Transendocardial Mesenchymal Stem Cells and Mononuclear Bone Marrow Cells']","['Erectile Function', 'Erectile Function (IIEF) scores', 'IIEF-EF score', 'erectile function', 'median IIEF-EF score', 'IIEF data']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0349782', 'cui_str': 'Generalized ischemic myocardial dysfunction (disorder)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018795', 'cui_str': 'Catheterization, Heart'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal Stem Cells'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0005955', 'cui_str': 'Bone Marrow Cells'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",36.0,0.430963,"When analyzed by cell dose, the IIEF-EF score in men who received 200 million cells increased significantly over 12 months (14 [4-23] to 20 [15-24.5], P = .014.)","[{'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Ory', 'Affiliation': 'Department of Urology, Dalhousie University, Halifax, NS, Canada; Department of Urology, Miller School of Medicine, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Russell G', 'Initials': 'RG', 'LastName': 'Saltzman', 'Affiliation': 'Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Blachman-Braun', 'Affiliation': 'Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dadoun', 'Affiliation': 'Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Darcy L', 'Initials': 'DL', 'LastName': 'DiFede', 'Affiliation': 'Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Premer', 'Affiliation': 'Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Hurwitz', 'Affiliation': 'Behavioral Medicine Research Center, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Hare', 'Affiliation': 'Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Ranjith', 'Initials': 'R', 'LastName': 'Ramasamy', 'Affiliation': 'Department of Urology, Miller School of Medicine, University of Miami, Miami, FL, USA; Miller School of Medicine, Interdisciplinary Stem Cell Institute, University of Miami, Miami, FL, USA. Electronic address: ramasamy@miami.edu.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.01.003']
365,32035516,"Late boosting of the RV144 regimen with AIDSVAX B/E and ALVAC-HIV in HIV-uninfected Thai volunteers: a double-blind, randomised controlled trial.","BACKGROUND


The RV144 phase 3 vaccine trial in Thailand demonstrated that ALVAC-HIV (vCP1521) and AIDSVAX B/E administration over 6 months resulted in a 31% efficacy in preventing HIV acquisition. In this trial, we assessed the immunological effect of an additional vaccine boost to the RV144 regimen at varying intervals between the priming vaccine series and the boost.
METHODS


RV306 is a double-blind, placebo-controlled, randomised clinical trial done at three clinical sites in Thailand. Eligible volunteers were HIV-uninfected individuals aged 20-40 years who were at low risk for HIV infection and in good health. A randomisation schedule was centrally generated with fixed sized strata for Research Institute for Health Sciences Chiang Mai and combined Bangkok clinics. Participants were randomly assigned to one of five groups and then further randomly assigned to either vaccine or placebo. All participants received the primary RV144 vaccine series at months 0, 1, 3, and 6. Group 1 received no additional boost, group 2 received additional AIDSVAX B/E and ALVAC-HIV (vCP1521) or placebo at month 12, group 3 received AIDSVAX B/E alone or placebo at month 12, group 4a received AIDSVAX B/E and ALVAC-HIV or placebo at month 15, and group 4b received AIDSVAX B/E and ALVAC-HIV or placebo at month 18. Primary outcomes were safety and tolerability of these vaccination regimens and cellular and humoral immune responses compared between the RV144 series alone and regimens with late boosts at different timepoints. Safety and tolerability outcomes were assessed by evaluating local and systemic reactogenicity and adverse events in all participants. This trial is registered at ClinicalTrials.gov (NCT01931358); clinical follow-up is now complete.
FINDINGS


Between Oct 28, 2013, and April 29, 2014, 367 participants were enrolled, of whom 27 were assigned active vaccination in group 1, 102 in group 2, 101 in group 3, 52 in group 4a, 51 in group 4b, and 34 combined placebo across all the groups. No vaccine-related serious adverse events were recorded. Occurrence and severity of local and systemic reactogenicity were similar across active groups. Groups with late boosts (groups 2, 3, 4a, and 4b) had increased peak plasma IgG-binding antibody levels against gp70 V1V2 relative to group 1 vaccine recipients with no late boost (gp70 V1V2 92TH023 adjusted p<0·02 for each; gp70 V1V2 CaseA2 adjusted p<0·0001 for each). Boosting at month 12 (groups 2 and 3) did not increase gp120 responses compared with the peak responses after the RV144 priming regimen at month 6; however, boosting at month 15 (group 4a) improved responses to gp120 A244gD- D11 (p=0·0003), and boosting at month 18 (group 4b) improved responses to both gp120 A244gD- D11 (p<0·0001) and gp120 MNgD- D11 (p=0·0016). Plasma IgG responses were significantly lower among vaccine recipients boosted at month 12 (pooled groups 2 + 3) than at month 15 (group 4a; adjusted p<0·0001 for each, except for gp70 V1V2 CaseA2, p=0·0142) and at month 18 (group 4b; all adjusted p<0·001). Boosting at month 18 versus month 15 resulted in a significantly higher plasma IgG response to gp120 antigens (all adjusted p<0·01) but not gp70 V1V2 antigens. CD4 functionality and polyfunctionality scores after stimulation with HIV-1 Env peptides (92TH023) increased with delayed boosting. Groups with late boosts had increased functionality and polyfunctionality scores relative to vaccine recipients with no late boost (all adjusted p<0·05, except for the polyfunctionality score in group 1 vs group 4b, p<0·01).
INTERPRETATION


Taken together, these results suggest that additional boosting of the RV144 regimen with longer intervals between the primary vaccination series and late boost improved immune responses and might improve the efficacy of preventing HIV acquisition.
FUNDING


US National Institute of Allergy and Infectious Diseases and US Department of the Army.",2020,Boosting at month 18 versus month 15 resulted in a significantly higher plasma IgG response to gp120 antigens (all adjusted p<0·01) but not gp70 V1V2 antigens.,"['Eligible volunteers were HIV-uninfected individuals aged 20-40 years who were at low risk for HIV infection and in good health', 'HIV-uninfected Thai volunteers', 'Between Oct 28, 2013, and April 29, 2014, 367 participants were enrolled, of whom 27 were assigned']","['AIDSVAX B/E and ALVAC-HIV or placebo', 'vaccine or placebo', 'placebo', 'additional AIDSVAX B/E and ALVAC-HIV (vCP1521) or placebo', 'AIDSVAX B/E alone or placebo', 'AIDSVAX B/E and ALVAC-HIV', 'MNgD', 'active vaccination']","['CD4 functionality and polyfunctionality scores', 'safety and tolerability of these vaccination regimens and cellular and humoral immune responses', 'peak plasma IgG-binding antibody levels against gp70 V1V2 relative', 'functionality and polyfunctionality scores', 'Plasma IgG responses', 'Occurrence and severity of local and systemic reactogenicity', 'local and systemic reactogenicity and adverse events', 'Safety and tolerability outcomes', 'plasma IgG response']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0337910', 'cui_str': 'Thai'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0675907', 'cui_str': 'ALVAC-HIV'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1155229'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",367.0,0.327131,Boosting at month 18 versus month 15 resulted in a significantly higher plasma IgG response to gp120 antigens (all adjusted p<0·01) but not gp70 V1V2 antigens.,"[{'ForeName': 'Punnee', 'Initials': 'P', 'LastName': 'Pitisuttithum', 'Affiliation': 'Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sorachai', 'Initials': 'S', 'LastName': 'Nitayaphan', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Suwat', 'Initials': 'S', 'LastName': 'Chariyalertsak', 'Affiliation': 'Research Institute for Health Sciences and Faculty of Public Health, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Jaranit', 'Initials': 'J', 'LastName': 'Kaewkungwal', 'Affiliation': 'Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'The Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Jittima', 'Initials': 'J', 'LastName': 'Dhitavat', 'Affiliation': 'Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Benjaluck', 'Initials': 'B', 'LastName': 'Phonrat', 'Affiliation': 'Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Siriwat', 'Initials': 'S', 'LastName': 'Akapirat', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Nicos', 'Initials': 'N', 'LastName': 'Karasavvas', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; Viral Diseases Branch, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Wieczorek', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Polonis', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Eller', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Pegu', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Dohoon', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Schuetz', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Surat', 'Initials': 'S', 'LastName': 'Jongrakthaitae', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Yingjun', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'The Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Faruk', 'Initials': 'F', 'LastName': 'Sinangil', 'Affiliation': 'Global Solutions for Infectious Diseases, South San Francisco, CA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Phogat', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA; GlaxoSmithKline, Siena, Italy.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Diazgranados', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tartaglia', 'Affiliation': 'Sanofi Pasteur, Swiftwater, PA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Heger', 'Affiliation': 'US Army Medical Materiel Development Activity, Fort Detrick, MD, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Excler', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA; International Vaccine Institute, Seoul, South Korea.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; International Vaccine Institute, Seoul, South Korea.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': ""O'Connell"", 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Vasan', 'Affiliation': 'Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand; US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA; Henry M Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA. Electronic address: svasan@hivresearch.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(19)30406-0']
366,32088398,Frailty modifies the intervention effect of chair yoga on pain among older adults with lower extremity osteoarthritis: Secondary analysis of a nonpharmacological intervention trial.,"OBJECTIVE


In an 8-week nonpharmacological pain intervention trial among older adults with lower extremity osteoarthritis (OA), we aimed to examine: a) the baseline frailty level of the participants; b) whether such intervention is more beneficial for baseline frailer older adults than for their counterparts with less frailty; and c) whether the intervention could also alter frailty.
METHODS


Participants were randomly assigned to either chair yoga (CY) or health education program (HEP) groups and attended twice-weekly 45-minute CY or HEP sessions for 8 weeks. Following a standard procedure, 82 variables were used to construct a frailty index (FI, 0-1). Primary outcomes were: Western Ontario and McMaster Universities (WOMAC) pain and pain interference. Linear mixed-effects models were used to evaluate the modifying effect of baseline frailty on the intervention effect of CY on primary outcomes. Similar models were used to evaluate the effect of CY on frailty.
RESULTS


A total of 112 participants (n = 63 CY, n = 49 HEP; 75.3 [SD = 7.5] years) with 85 females (75.9%) were included. The mean values of baseline FI for the CY and HEP groups were similar (0.428 [0.05] and 0.433 [0.05], P = 0.355). Each 0.01 increment in baseline FI was associated with higher WOMAC pain (beta = 0.28, P < 0.001) and pain interference (beta = 0.51, P < 0.001). There was a significant interaction effect between intervention, time, and baseline FI (P = 0.020 for WOMAC pain; P = 0.010 for pain interference), indicating that participants with higher level of baseline FI had greater declines in WOMAC pain and pain interference. There was no significantly greater decline in FI for the CY group compared to the HEP group (between-group difference - 0.01; P = 0.509) and there were no significant trend changes in FI (P for interaction = 0.605).
CONCLUSIONS


Frailty modifies the intervention effect of CY on pain among older adults with lower extremity OA, underscoring the importance of assessing frailty to improve the management of pain in this population.",2020,"There was no significantly greater decline in FI for the CY group compared to the HEP group (between-group difference - 0.01; P = 0.509) and there were no significant trend changes in FI (P for interaction = 0.605).
","['older adults with lower extremity OA', 'older adults with lower extremity osteoarthritis (OA', '112 participants (n\u202f=\u202f63 CY, n\u202f=\u202f49 HEP; 75.3 [SD\u202f=\u202f7.5] years) with 85 females (75.9%) were included', 'older adults with lower extremity osteoarthritis', 'Participants', 'baseline frailer older adults than for their counterparts with less frailty; and c']","['chair yoga', 'HEP', 'chair yoga (CY) or health education program (HEP) groups and attended twice-weekly 45-minute CY or HEP sessions']","['WOMAC pain and pain interference', 'pain interference', 'decline in FI', 'mean values of baseline FI', 'WOMAC pain', 'pain', 'Western Ontario and McMaster Universities (WOMAC) pain and pain interference']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0449198', 'cui_str': 'HEP (body structure)'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0449198', 'cui_str': 'HEP (body structure)'}, {'cui': 'C0018701'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]",112.0,0.0843184,"There was no significantly greater decline in FI for the CY group compared to the HEP group (between-group difference - 0.01; P = 0.509) and there were no significant trend changes in FI (P for interaction = 0.605).
","[{'ForeName': 'Juyoung', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Florida Atlantic University, Phyllis and Harvey Sandler School of Social Work, Boca Raton, FL, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Sherman', 'Affiliation': 'Florida Atlantic University, Phyllis and Harvey Sandler School of Social Work, Boca Raton, FL, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Agogo', 'Affiliation': 'Centers for Disease Control and Prevention (CDC), Village Market, Nairobi, Kenya; Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Emiel O', 'Initials': 'EO', 'LastName': 'Hoogendijk', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, Amsterdam UMC-location VU University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Zuyun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Pathology, Yale School of Medicine, New Haven, CT, USA; Department of Precision Health and Data Science, School of Public Health and the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. Electronic address: zuyun.liu@yale.edu.'}]",Experimental gerontology,['10.1016/j.exger.2020.110886']
367,32248227,Electrical Stimulation Therapies for Active Duty Military with Patellofemoral Pain Syndrome: A Randomized Trial.,"INTRODUCTION


Patellofemoral pain syndrome (PFPS) is a common musculoskeletal disorder among military service members that causes knee pain, quadriceps strength loss, and impaired motor performance in otherwise healthy individuals. PFPS poses a threat to the health, fitness, and subsequent readiness of the total force. The goal of rehabilitation for military service members with PFPS is to regain physical capacity of strength and function and to reduce pain, in order to restore readiness in this population. The randomized controlled trial reported here compared an active home exercise program (HEP) alone with three different electrical stimulation treatment regimens implemented concurrently with HEP postulated improvements in lower extremity strength and physical functional performance while also reducing pain in active duty military diagnosed with PFPS.
MATERIALS AND METHODS


After baseline testing, 130 active duty military members with PFPS were randomized to 1 of 4 treatment groups: (1) neuromuscular electrical stimulation (NMES) with HEP; (2) transcutaneous electrical nerve stimulation (TENS) with HEP; (3) combined NMES/TENS with HEP; (4) active HEP only. The primary outcome measure was degree of change in knee flexion and extension strength over 9 weeks. Secondary outcomes were physical functional performance and knee pain. The primary analyses used repeated measures, linear mixed-effects models with a random effect for subject, time as a continuous variable, group as a categorical variable, and a group and time interaction to test for differences in change over time among the groups.
RESULTS


All three electrical stimulation treatment groups improved in knee extension strength in the PFPS limb to a greater extent than the HEP alone group over the 9-week treatment period. The NMES and NMES/TENS groups improved to a greater extent than the HEP alone group in knee flexion strength in the PFPS limb. The reported pain improved over time for all treatment groups with no significant group differences. All three stimulation groups performed better on the 6-min walk test than the HEP alone group.
CONCLUSION


The findings from this study showed that all three electrical stimulation with HEP treatment groups showed greater improvement in strength compared to the HEP alone group. These findings could offer alternative forms of rehabilitation for AD military with PFPS as these treatment regimens can be easily implemented at home station or during deployment.",2020,The NMES and NMES/TENS groups improved to a greater extent than the HEP alone group in knee flexion strength in the PFPS limb.,"['otherwise healthy individuals', 'Active Duty Military with Patellofemoral Pain Syndrome', 'military service members with', 'active duty military diagnosed with PFPS', '130 active duty military members with PFPS']","['active home exercise program (HEP', 'Electrical Stimulation Therapies', 'neuromuscular electrical stimulation (NMES) with HEP; (2) transcutaneous electrical nerve stimulation (TENS) with HEP; (3) combined NMES/TENS with HEP; (4) active HEP only', 'HEP', 'PFPS']","['physical functional performance and knee pain', 'knee flexion strength', 'pain', 'knee extension strength', 'lower extremity strength and physical functional performance', 'strength', 'degree of change in knee flexion and extension strength']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0877149', 'cui_str': 'Patellofemoral pain syndrome'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0162569', 'cui_str': 'Homozygous porphyria cutanea tarda'}, {'cui': 'C0013787', 'cui_str': 'Electrotherapy'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014518', 'cui_str': 'Lyell syndrome'}]","[{'cui': 'C4704690', 'cui_str': 'Physical Functional Performance'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",130.0,0.0562604,The NMES and NMES/TENS groups improved to a greater extent than the HEP alone group in knee flexion strength in the PFPS limb.,"[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Talbot', 'Affiliation': 'Department of Neurology, College of Medicine, University of Tennessee Health Science Center, 855 Monroe Ave, Suite 415, Memphis, TN 38163.'}, {'ForeName': 'Zack', 'Initials': 'Z', 'LastName': 'Solomon', 'Affiliation': 'Physical Therapy Services, Dunham U.S. Army Health Clinic, Carlisle Barracks, PA 17013.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Webb', 'Affiliation': 'Byrd Clinic Physical Therapy, Fort Campbell, KY 42240.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Morrell', 'Affiliation': 'Department of Mathematics and Statistics, Loyola University Maryland, Baltimore, MD 21210-2699.'}, {'ForeName': 'E Jeffrey', 'Initials': 'EJ', 'LastName': 'Metter', 'Affiliation': 'Department of Neurology, College of Medicine, University of Tennessee Health Science Center, 855 Monroe Ave, Suite 415, Memphis, TN 38163.'}]",Military medicine,['10.1093/milmed/usaa037']
368,32064639,"Combining whole-school and targeted programs for the reduction of bullying victimization: A randomized, effectiveness trial.","Despite the extensive evaluation of school-based interventions for bullying, victimization remains a significant problem in schools. Bullying victimization is significantly predicted by contextual (school-related) factors. As a consequence whole-school programs have been commonly used to prevent and reduce bullying victimization. Evidence also points to individual risk factors (such as emotional distress) in predicting victimization, yet programs to prevent bullying victimization by changing these individual risks are far less developed. Few studies have approximated ""real-world"" implementation conditions in their trials. The current effectiveness trial evaluated the combination of a whole-school program designed to prevent bullying perpetration and victimization together with a targeted intervention for at-risk students, teaching them individual and dyadic strategies to reduce their anxiety and manage victimization, allowing schools some latitude to implement programs as they typically would. Students from Grades 3 and 4 (N = 8,732) across 135 schools were randomly assigned to one of four conditions: combined intervention; whole-school intervention only; individual intervention only; and care as usual. Victimization decreased significantly and similarly across all four conditions at 12 and 24 months following baseline. Similar reductions and failure to discriminate conditions were found on other key constructs: anxiety; bullying perpetration; and depression. Possible reasons for the failure to demonstrate victimization prevention differences and lessons learned from this large, effectiveness trial are considered.",2020,Similar reductions and failure to discriminate conditions were found on other key constructs: anxiety; bullying perpetration; and depression.,"['Students from Grades 3 and 4 (N\u2009=\u20098,732) across 135 schools']",['combined intervention; whole-school intervention only; individual intervention only; and care as usual'],"['Bullying victimization', 'Victimization']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}]",,0.0274574,Similar reductions and failure to discriminate conditions were found on other key constructs: anxiety; bullying perpetration; and depression.,"[{'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Shaw', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hunt', 'Affiliation': 'School of Psychology, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Bussey', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Hudson', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'Deakin Health Economics, Centre for Population Health Research, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Roberts', 'Affiliation': 'Edith Cowan University, Perth, Western Australia, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Radom', 'Affiliation': 'Department of Psychology, Centre for Emotional Health, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Cordin', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Epstein', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Cross', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}]",Aggressive behavior,['10.1002/ab.21881']
369,32240629,Once-weekly rifapentine and isoniazid for tuberculosis prevention in patients with HIV taking dolutegravir-based antiretroviral therapy: a phase 1/2 trial.,"BACKGROUND


Short-course preventive therapy with 12 doses of once-weekly rifapentine (900 mg) plus isoniazid (900 mg) could greatly improve tuberculosis control, especially in areas with high co-endemicity with HIV. However, a small previous trial of such therapy with dolutegravir in healthy, HIV-negative adults was halted early after two of the four patients developed serious adverse events. Because of the potential use of this therapy, and variable safety outcomes of tuberculosis drugs seen in patients with and without HIV, we aimed to characterise safety, pharmacokinetics, and virological suppression in adults who are HIV positive.
METHODS


DOLPHIN was a phase 1/2, single-arm trial done at The Aurum Institute (Tembisa Clinical Research Site, Tembisa, South Africa), with pharmacokinetic visits done at VxPharma (Pretoria, South Africa). Adults (≥18 years) with HIV infection and undetectable viral load (<40 copies per mL) after at least 8 weeks of efavirenz-based or dolutegravir-based regimens were recruited in three consecutive groups, subject to approval by the independent safety monitoring committee. Participants received 50 mg of daily dolutegravir in place of efavirenz for 8 weeks, then began once-weekly rifapentine (900 mg)-isoniazid (900 mg) for 12 weeks. Groups 1A (n=12) and 1B (n=18) had intensive dolutegravir pharmacokinetic sampling at week 8 (before rifapentine-isoniazid), at week 11 (after the third dose of rifapentine)-isoniazid and at week 16 after the eighth dose. Group 2 (n=30) were treated with the same schedule and had sparse dolutegravir pharmacokinetic sampling at weeks 8, 11, and 16. Participants were followed 4 weeks after completion of prophylactic tuberculosis treatment. HIV viral loads were measured at baseline and at weeks 11 and 24. Primary endpoints were adverse events (grade 3 or higher) and dolutegravir population pharmacokinetics, assessed in participants who began rifapentine-isoniazid. This trial was registered at ClinicalTrials.gov, NCT03435146.
FINDINGS


Between Jan 24, 2018, and Nov 25, 2018, 61 participants were enrolled into three groups; one participant withdrew (from group 1A). 43 (70%) of 60 participants were women and all participants were black African. Median age was 40 years (IQR 35-48), CD4 cell count was 683 cells per μL (447-935), and body-mass index was 28·9 kg/m 2  (24·0-32·9). Three grade 3 adverse events occurred; two elevated creatinine and one hypertension. Rifapentine-isoniazid increased dolutegravir clearance by 36% (relative standard error 13%) resulting in a 26% decrease in dolutegravir area under the curve. Overall geometric mean ratio of trough concentrations with versus without rifapentine-isoniazid was 0·53 (90% CI 0·49-0·56) though this ratio varied by day after rifapentine-isoniazid dose. All but one trough value was above the 90% maximal inhibitory concentration for dolutegravir and HIV viral loads were less than 40 copies per mL in all patients.
INTERPRETATION


Our results suggest 12 doses of once-weekly rifapentine-isoniazid can be given for tuberculosis prophylaxis to patients with HIV taking dolutegravir-based antiretroviral therapy, without dose adjustments. Further exploration of the pharmacokinetics, safety, and efficacy in children and pharmacodynamics in individuals naive to antiretroviral therapy is needed.
FUNDING


UNITAID.",2020,Rifapentine-isoniazid increased dolutegravir clearance by 36% (relative standard error 13%) resulting in a 26% decrease in dolutegravir area under the curve.,"['43 (70%) of 60 participants were women and all participants were black African', 'patients with HIV taking dolutegravir-based antiretroviral therapy', 'Adults (≥18 years) with HIV infection and undetectable viral load (<40 copies per mL) after at least 8 weeks of', 'Median age was 40 years (IQR 35-48), CD4 cell count was 683 cells per μL (447-935), and body-mass index was 28·9 kg/m 2  (24·0-32·9', 'DOLPHIN was a phase 1/2, single-arm trial done at The Aurum Institute (Tembisa Clinical Research Site, Tembisa, South Africa), with pharmacokinetic visits done at VxPharma (Pretoria, South Africa', 'adults who are HIV positive', 'Between Jan 24, 2018, and Nov 25, 2018, 61 participants were enrolled into three groups; one participant withdrew (from group 1A', 'children and pharmacodynamics in individuals naive to antiretroviral therapy', 'patients with and without HIV', 'areas with high co-endemicity with HIV']","['Rifapentine-isoniazid', 'daily dolutegravir in place of efavirenz', 'rifapentine-isoniazid', 'rifapentine and isoniazid', 'rifapentine', 'isoniazid', 'efavirenz-based or dolutegravir-based regimens', 'rifapentine)-isoniazid']","['dolutegravir and HIV viral loads', 'dolutegravir clearance', 'Overall geometric mean ratio of trough concentrations', 'dolutegravir area', 'intensive dolutegravir pharmacokinetic sampling', 'HIV viral loads', 'adverse events (grade 3 or higher) and dolutegravir population pharmacokinetics', 'serious adverse events']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0337824', 'cui_str': 'Black African'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0013005', 'cui_str': 'Dolphin'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0441862', 'cui_str': 'Group 1A'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0073372', 'cui_str': 'rifapentine'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",61.0,0.385174,Rifapentine-isoniazid increased dolutegravir clearance by 36% (relative standard error 13%) resulting in a 26% decrease in dolutegravir area under the curve.,"[{'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: kdooley1@jhmi.edu.'}, {'ForeName': 'Radojkam', 'Initials': 'R', 'LastName': 'Savic', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Gupte', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Vinodh A', 'Initials': 'VA', 'LastName': 'Edward', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa; School of Pathology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Environmental Health Sciences, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wolf', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Modulakgotla', 'Initials': 'M', 'LastName': 'Sebe', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Morongwe', 'Initials': 'M', 'LastName': 'Likoti', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Fyvie', 'Affiliation': 'Vx Pharma, Pretoria, South Africa.'}, {'ForeName': 'Innocent', 'Initials': 'I', 'LastName': 'Shibambo', 'Affiliation': 'Vx Pharma, Pretoria, South Africa.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Beattie', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Chaisson', 'Affiliation': 'Center for Tuberculosis Research, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gavin J', 'Initials': 'GJ', 'LastName': 'Churchyard', 'Affiliation': 'The Aurum Institute, Johannesburg, South Africa; School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30032-1']
370,32100888,Relations between forms and functions of aggression and moral judgments of aggressive transgressions.,"The present study sought to examine the influence of aggressive behavior, psychopathy, and gender on moral judgments of aggressive transgressions. A two-dimensional conceptualization of aggression was used, such that proactive relational aggression, reactive relational aggression, proactive physical aggression, and reactive physical aggression were treated as distinct subtypes of aggression and also as distinct subtypes of moral judgments of aggression. Participants were 421 emerging adults (215 women). Self-report measures of aggression, psychopathy, and moral judgments were collected. Peer-reports of aggression and psychopathy were obtained from a randomly assigned subsample of 73 participants (46 women) for validity purposes. Unique associations were found between subtypes of aggression and corresponding moral judgments of the same subtypes.",2020,Unique associations were found between subtypes of aggression and corresponding moral judgments of the same subtypes.,"['Participants were 421 emerging adults (215 women', '73 participants (46 women) for validity purposes']",[],"['proactive relational aggression, reactive relational aggression, proactive physical aggression, and reactive physical aggression']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}]",[],"[{'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0424323', 'cui_str': 'Physical aggression (finding)'}]",421.0,0.0275516,Unique associations were found between subtypes of aggression and corresponding moral judgments of the same subtypes.,"[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Hart', 'Affiliation': 'University at Buffalo, The State University of New York, Buffalo, New York.'}, {'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Ostrov', 'Affiliation': 'University at Buffalo, The State University of New York, Buffalo, New York.'}]",Aggressive behavior,['10.1002/ab.21883']
371,31993722,One-Step Multichannel Percutaneous Transhepatic Cholangioscopic Lithotripsy Applied in Bilateral Hepatolithiasis.,"BACKGROUND


The aim of this study was to compare the outcomes of one-step multichannel percutaneous transhepatic cholangioscopic lithotripsy (PTCSL) with traditional PTCSL in the treatment of bilateral hepatolithiasis.
METHODS


From February 2011 to June 2015, 156 patients with bilateral hepatolithiasis received surgical treatment in our department. Among these patients, 81 received one-step multichannel PTCSL (group A), and the remaining 75 received traditional PTCSL (group B).
RESULTS


Compared with group B, group A was characterized by a significantly shorter operation time (83.7 ± 28.5 min vs 118.1 ± 41.5 min; P = 0.000), hospital stay (11.1 ± 3.4 d vs 17.8 ± 5.6 d; P = 0.034), and postoperative hospital stay (6.9 ± 3.1 d vs 9.6 ± 4.5 d; P = 0.026). In addition, the immediate clearance (62.9% vs 45.3%, P = 0.027) and final clearance (90.1% vs 78.7%, P = 0.048) rates were higher in group A than in group B. During the follow-up period, stone recurrence was significantly less common in group A than in group B (13.6% vs 26.7%, P = 0.041). Multivariate Cox analysis showed that the PTCSL method (HR = 2.32, 95% confidence interval [CI] = 1.09-4.90, P = 0.028), bilateral biliary stricture (HR = 4.17, 95% CI = 1.73-10.03, P = 0.001), and stones located in segments I (HR = 7.75, 95% CI = 3.67-16.38, P = 0.000) were independent predictors of recurrence.
CONCLUSIONS


Compared with traditional PTCSL, one-step multichannel PTCSL was more efficient and effective in the treatment of bilateral hepatolithiasis.",2020,"In addition, the immediate clearance (62.9% vs 45.3%, P = 0.027) and final clearance (90.1% vs 78.7%, P = 0.048) rates were higher in group A than in group B.","['From February 2011 to June 2015, 156 patients with bilateral hepatolithiasis received surgical treatment in our department']","['multichannel percutaneous transhepatic cholangioscopic lithotripsy (PTCSL) with traditional PTCSL', 'multichannel PTCSL', 'traditional PTCSL', 'Multichannel Percutaneous Transhepatic Cholangioscopic Lithotripsy']","['final clearance', 'immediate clearance', 'bilateral biliary stricture', 'stone recurrence', 'postoperative hospital stay', 'shorter operation time', 'hospital stay']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0522516', 'cui_str': 'Transhepatic approach (qualifier value)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0597984', 'cui_str': 'Biliary stricture (disorder)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",156.0,0.0544153,"In addition, the immediate clearance (62.9% vs 45.3%, P = 0.027) and final clearance (90.1% vs 78.7%, P = 0.048) rates were higher in group A than in group B.","[{'ForeName': 'Haisu', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, Hubei Province, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510282, Guangdong Province, China. wangping_dr@126.com.'}, {'ForeName': 'Beiwang', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510282, Guangdong Province, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510282, Guangdong Province, China.'}, {'ForeName': 'Canhua', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Hepatobiliary Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510282, Guangdong Province, China.'}]",World journal of surgery,['10.1007/s00268-020-05368-7']
372,32224548,Evaluation of the Efficacy of Porous Titanium Granules in the Treatment of Periodontal Intrabony Defects: A Preliminary Report.,"BACKGROUND AND OBJECTIVES


Applications of porous titanium granule (PTG) in periodontal (furcation defects) and non-periodontal treatments have shown promising results. However, its role in periodontal intrabony defects still remains unexplored. Thus, we aim to assess the feasibility of PTG in obtaining reconstruction in intrabony defects and compare the outcome with that of open flap debridement (OFD).
METHODS


Ten patients (three females and seven males) with a mean age of 34.7 years who constituted twenty (20) bilateral intrabony defects were recruited. Each patient contributed to two defects which were randomly treated by OFD alone (control group) or by OFD followed by grafting with PTG (test group). All the clinical and radiological parameters were recorded at baseline, three, six and nine months and statistically analyzed.
RESULTS


The results of this study demonstrated that in clinical parameters there is no significant differences in the improvement from baseline to nine months. However, regarding the radiographic defect fill, there was significant gain from baseline to nine months only in the PTG sites.
CONCLUSION


Within the limits of our study, the results of this trial indicate that reconstructive periodontal surgery with PTG offers minimal radiographic defect resolution with no significant improvements in clinical endpoints compared to open flap debridement.",2020,"However, regarding the radiographic defect fill, there was significant gain from baseline to nine months only in the PTG sites.
","['Ten patients (three females and seven males) with a mean age of 34.7 years who constituted twenty (20) bilateral intrabony defects were recruited', 'Periodontal Intrabony Defects']","['Porous Titanium Granules', 'OFD alone (control group) or by OFD followed by grafting with PTG', 'open flap debridement (OFD', 'porous titanium granule (PTG', 'PTG']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C3853573', 'cui_str': 'Granules'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]",[],,0.0293577,"However, regarding the radiographic defect fill, there was significant gain from baseline to nine months only in the PTG sites.
","[{'ForeName': 'Vasudevalu', 'Initials': 'V', 'LastName': 'Sujatha', 'Affiliation': 'Department of Periodontics and Implantology, Krishnadevaraya College of Dental Sciences and Hospital, Krishnadevarayanagar, Hunsmaranahalli, International Airport Road, Bengaluru- 562157, Karnataka, India.'}, {'ForeName': 'Karthikeyan Bangalore', 'Initials': 'KB', 'LastName': 'Varadhan', 'Affiliation': 'Department of Periodontics and Implantology, Krishnadevaraya College of Dental Sciences and Hospital, Krishnadevarayanagar, Hunsmaranahalli, International Airport Road, Bengaluru- 562157, Karnataka, India. Email drkarthikeyanbv@gmail.com.'}, {'ForeName': 'Prabhuji Munivenkatappa Lakshmaiah', 'Initials': 'PML', 'LastName': 'Venkatesh', 'Affiliation': 'Department of Periodontics and Implantology, Krishnadevaraya College of Dental Sciences and Hospital, Krishnadevarayanagar, Hunsmaranahalli, International Airport Road, Bengaluru- 562157, Karnataka, India.'}, {'ForeName': 'Pragathi', 'Initials': 'P', 'LastName': 'Modi', 'Affiliation': 'Department of Periodontics and Implantology, Krishnadevaraya College of Dental Sciences and Hospital, Krishnadevarayanagar, Hunsmaranahalli, International Airport Road, Bengaluru- 562157, Karnataka, India.'}, {'ForeName': 'Ashwin Parakkaje', 'Initials': 'AP', 'LastName': 'Subramanya', 'Affiliation': 'Department of Periodontics and Implantology, Krishnadevaraya College of Dental Sciences and Hospital, Krishnadevarayanagar, Hunsmaranahalli, International Airport Road, Bengaluru- 562157, Karnataka, India.'}]",Journal of the International Academy of Periodontology,[]
373,31431654,Lack of social support as measured by the Family Resource Scale screening tool is associated with early adverse cognitive outcome in extremely low birth weight children.,"OBJECTIVE


Extremely low birth weight children are at high risk for cognitive impairment.
STUDY DESIGN


Cognitive outcome of extremely low birth weight children participating in a Neonatal Research Network, randomized trial was evaluated at 18 and 30 months corrected age using the Bayley Scales of Infant Development, 2nd ed. Family resources and social support were assessed using a Family Resource Scale parent questionnaire. Regression analysis was used to determine independent demographic, medical, and family resource factors influencing longitudinal cognitive outcome.
RESULT


Higher Family Resource Scale scores at 18 months were associated with greater improvement in cognitive scores between 18 and 30 months. Cognitive outcome was most adversely affected in children whose families had the least resources and social support. The adverse effect of poor social support was independent of family income.
CONCLUSION


Poor interpersonal social support has an independent, adverse impact on cognitive outcomes of extremely low birth weight infants.",2019,Cognitive outcome was most adversely affected in children whose families had the least resources and social support.,"['extremely low birth weight infants', 'extremely low birth weight children participating in a Neonatal Research Network, randomized trial was evaluated at 18 and 30 months corrected age using the Bayley Scales of Infant Development, 2nd ed', 'extremely low birth weight children']",[],"['Cognitive outcome', 'Higher Family Resource Scale scores', 'cognitive scores']","[{'cui': 'C0456065', 'cui_str': 'Infant, Extremely Low Birth Weight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development (assessment scale)'}, {'cui': 'C0205436', 'cui_str': 'Second - ordinal'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0599714,Cognitive outcome was most adversely affected in children whose families had the least resources and social support.,"[{'ForeName': 'Martha G', 'Initials': 'MG', 'LastName': 'Fuller', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of California San Diego, San Diego, CA, USA. mfuller@sandiego.edu.'}, {'ForeName': 'Yvonne E', 'Initials': 'YE', 'LastName': 'Vaucher', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Bann', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Abhik', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina, NC, USA.'}, {'ForeName': 'Betty R', 'Initials': 'BR', 'LastName': 'Vohr', 'Affiliation': 'Department of Pediatrics, Women, and Infants Hospital, Brown University, Providence, RI, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0462-2']
374,32093546,Leveraging the experience of stressors: the role of adaptive systematic self-reflection.,"Background:  To date, little attention has been paid to the processes by which resilience is developed, and how the likelihood of a resilient outcome may be enhanced over the life course.  Objective:  This study investigates the potential for adaptive systematic self-reflection to support the development of situation resilience via stressor exposure.  Design:  An experimental randomized controlled design was conducted. Participants were randomly assigned to either the Systematic Self-reflection intervention ( n  = 61) or disengagement control group ( n  = 60).  Method:  Participants were 121 university students (female   = 68%) ranging in age from 18 to 56 years. Participants experienced two psychosocial stressors and completed a baseline survey, a second survey occurred post-stressor 1, and a third post-stressor 2. Salivary cortisol was taken pre stressor 2, immediately post stressor 2, and at 10 min intervals until 30 min.  Results:  The intervention was associated with greater reductions in negative affect, than a disengagement control task, and prevented the continued reduction in positive affect observed in the disengagement control condition. Moreover, the intervention promoted a steeper cortisol recovery trajectory, than the control condition for those with higher pre-stressor cortisol.  Conclusions:  This study provides further evidence that certain self-reflective practices may be involved in the development of resilience from stressor exposure.",2020,"The intervention was associated with greater reductions in negative affect, than a disengagement control task, and prevented the continued reduction in positive affect observed in the disengagement control condition.",['Participants were 121 university students (female \u2009 =\u200968%) ranging in age from 18 to 56 years'],['Systematic Self-reflection intervention ( n\u2009 =\u200961) or disengagement control group ( n\u2009 =\u200960'],"['steeper cortisol recovery trajectory', 'Salivary cortisol']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}]",,0.0248004,"The intervention was associated with greater reductions in negative affect, than a disengagement control task, and prevented the continued reduction in positive affect observed in the disengagement control condition.","[{'ForeName': 'Monique F', 'Initials': 'MF', 'LastName': 'Crane', 'Affiliation': 'Department of Psychology, Macquarie University, North Ryde, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kangas', 'Affiliation': 'Department of Psychology, Centre for Emotional HealthMacquarie University, North Ryde, Australia.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Karin', 'Affiliation': 'Department of Psychology, eCentre Clinic, Macquarie University, North Ryde, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Searle', 'Affiliation': 'Department of Psychology, Macquarie University, North Ryde, Australia.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology, Macquarie University, North Ryde, Australia.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1732359']
375,32093766,Acute effects of Nitrosigine® and citrulline malate on vasodilation in young adults,"BACKGROUND


Athletes are increasingly exploring ways to enhance their physical performance. Increasing blood flow to the working tissues through endothelium-dependent vasodilation is one factor athletes use to realize these results. Sports supplements such as pre-workouts tout this benefit; however, many have not been tested under laboratory conditions to examine the effects of commonly used supplements on vasodilation. Two popular supplements are Nitrosigine® and citrulline malate (CM). Thus, the purpose of this experiment was to determine the effects of Nitrosigine and CM on vasodilation using ultrasound and flow mediated dilation (FMD).
METHODS


Healthy, normotensive, and physically active male (n = 16) and female (n = 8) young adults participated in the present investigation. We utilized a randomized, double-blind, within-subjects design where participants reported for three trials, each preceded by a 7-day washout period. Baseline FMD measurement was obtained for each visit, followed by consumption of one clinical dose CM (8 g), Nitrosigine (1.5 g), or dextrose placebo (8 g). Following a 60-min digestion period, FMD was repeated. Supplementation order was randomized controlling for potential order effects.
RESULTS


Repeated measures ANOVA yielded a significant supplement (3) x time (2) effect (p < .001), such that Nitrosigine and CM yielded a greater improvement in FMD response than placebo. After supplementation, Nitrosigine and CM increased FMD by 31 and 34%, respectively, compared to a decrease of 2% during the placebo trial. After allometric scaling of the FMD values, supplement x time effect remained significant (p = .001) and changes were similar to non-scaled results. Nitrosigine (23%) and CM (25%) generated significantly greater allometric scaled FMD values when compared to the placebo trial (0.60%).
DISCUSSION


Both Nitrisigine and CM increased endothelial-dependent vasodilation as measured by a change in FMD. Increased vasodilation leads to an increase in skeletal muscle blood flow resulting in potential improvements in exercise performance.",2020,"After allometric scaling of the FMD values, supplement x time effect remained significant (p = .001) and changes were similar to non-scaled results.","['Healthy, normotensive, and physically active male (n\u2009=\u200916) and female (n\u2009=\u20098) young adults participated in the present investigation']","['placebo', 'Nitrosigine® and citrulline maleate', 'dextrose placebo']","['FMD response', 'vasodilation', 'allometric scaled FMD values', 'endothelial-dependent vasodilation', 'Nitrosigine® and citrulline malate (CM', 'Nitrosigine', 'Baseline FMD measurement', 'skeletal muscle blood flow', 'Nitrosigine and CM increased FMD']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4506347', 'cui_str': 'inositol-stabilized arginine silicate'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0024572', 'cui_str': 'Maleates'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}]","[{'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C0222045'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C4506347', 'cui_str': 'inositol-stabilized arginine silicate'}, {'cui': 'C0109943', 'cui_str': 'citrulline malate'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]",,0.36687,"After allometric scaling of the FMD values, supplement x time effect remained significant (p = .001) and changes were similar to non-scaled results.","[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Rogers', 'Affiliation': 'Exercise Science Research Center, University of Arkansas, 1 University of Arkansas, HPER 321-E, Fayetteville, AR, 72701, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Gills', 'Affiliation': 'Exercise Science Research Center, University of Arkansas, 1 University of Arkansas, HPER 321-E, Fayetteville, AR, 72701, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Gray', 'Affiliation': 'Exercise Science Research Center, University of Arkansas, 1 University of Arkansas, HPER 321-E, Fayetteville, AR, 72701, USA. rgray@uark.edu.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00343-y']
376,32124514,CALIBER: a phase II randomized feasibility trial of chemoablation with mitomycin-C vs surgical management in low-risk non-muscle-invasive bladder cancer.,"OBJECTIVES


To evaluate the activity of intravesical mitomycin-C (MMC) to ablate recurrent low-risk non-muscle-invasive bladder cancer (NMIBC) and assess whether it may enable patients to avoid surgical intervention for treatment of recurrence.
PATIENTS AND METHODS


CALIBER is a phase II feasibility study. Participants were randomized (2:1) to treatment with four once-weekly MMC 40-mg intravesical instillations (chemoablation arm) or to surgical management. The surgical group was included to assess the feasibility of randomization. The primary endpoint was complete response to intravesical MMC in the chemoablation arm at 3 months, reported with exact 95% confidence intervals (CIs). Secondary endpoints included time to subsequent recurrence, summarized by Kaplan-Meier methods.
RESULTS


Between February 2015 and August 2017, 82 patients with visual diagnosis of recurrent low-risk NMIBC were enrolled from 24 UK hospitals (chemoablation, n = 54; surgical management, n =28). The median follow-up was 24 months. Complete response at 3 months was 37.0% (20/54; 95% CI 24.3-51.3) with chemoablation and 80.8% (21/26; 95% CI 60.6-93.4) with surgical management. Amongst patients with complete response at 3 months, a similar proportion was recurrence-free by 12 months in both groups (84%). Amongst those with residual disease at 3 months, the 12-month recurrence-free proportion was lower in the surgical management group (40.0%) than in the chemoablation group (84%). Recruitment stopped early as chemoablation did not meet the prespecified threshold of 45% complete responses at 3 months.
CONCLUSION


Intravesical chemoablation in low-risk NMIBC is feasible and safe, but did not demonstrate sufficient response in the present trial. After chemoablation there may be a reduction in recurrence rate, even in non-responders, that is greater than with surgery alone. Further research is required to investigate the role and optimal schedule of neoadjuvant intravesical chemotherapy prior to surgery for NMIBC.",2020,"Intravesical chemoablation in low risk NMIBC is feasible and safe, but did not demonstrate sufficient response in this trial.","['Between February 2015 and August 2017', 'low risk non-muscle invasive bladder cancer', '82 patients with visual diagnosis of recurrent low risk NMIBC were enrolled from 24 UK hospitals (54 chemoablation, 28 surgical management']","['intravesical mitomycin C (MMC', 'mitomycin', 'MMC 40mg intravesical instillations (chemoablation arm) or surgical management']","['recurrence rate', 'Complete response', 'time to subsequent recurrence, summarised by Kaplan-Meier methods', '12-month recurrence-free proportion', 'complete response to intravesical MMC', 'recurrence-free']","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0442124', 'cui_str': 'Intravesical approach (qualifier value)'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0021917', 'cui_str': 'Instillation, Bladder'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach (qualifier value)'}]",82.0,0.125464,"Intravesical chemoablation in low risk NMIBC is feasible and safe, but did not demonstrate sufficient response in this trial.","[{'ForeName': 'A Hugh', 'Initials': 'AH', 'LastName': 'Mostafid', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cresswell', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Thomas R L', 'Initials': 'TRL', 'LastName': 'Griffiths', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Kelly', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Penegar', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Davenport', 'Affiliation': 'Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'McGrath', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Campain', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cooke', 'Affiliation': 'Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Shikohe', 'Initials': 'S', 'LastName': 'Masood', 'Affiliation': 'Medway NHS Foundation Trust, Gillingham, UK.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Knowles', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Feber', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Knight', 'Affiliation': 'Action Bladder Cancer UK, Gloucestershire, UK.'}, {'ForeName': 'James W F', 'Initials': 'JWF', 'LastName': 'Catto', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Institute of Cancer Research, London, UK.'}]",BJU international,['10.1111/bju.15038']
377,31181564,A randomized trial of an NMDA receptor antagonist for reversing corticosteroid effects on the human hippocampus.,"Preclinical and clinical research indicates that excess corticosteroid is associated with adverse effects on the hippocampus. Animal model data suggest that N-methyl-D-aspartate (NMDA) receptor antagonists may block corticosteroid effect on the hippocampus. This translational clinical trial investigated the effect of memantine vs. placebo on hippocampal subfield volume in humans receiving chronic corticosteroid therapy. Men and women (N = 46) receiving chronic prescription corticosteroid therapy were randomized to memantine or placebo in a double-blind, crossover design (two 24-week treatment periods, separated by a 4-week washout) for 52 weeks. Structural magnetic resonance imaging was obtained at baseline and after each treatment. Data were analyzed using repeated measures analysis of variance. Mean corticosteroid dose was 7.69 ± 6.41 mg/day and mean duration 4.90 ± 5.61 years. Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011). The findings suggest that an NMDA receptor antagonist attenuates corticosteroid effect in the same hippocampal subfields in humans as in animal models. This finding has both mechanistic and clinical implications. Attenuation of the effect of corticosteroids on the human DG/CA3 region implicates the NMDA receptor in human hippocampal volume losses with corticosteroids. In addition, by suggesting a drug class that may, at least in part, block the effects of corticosteroids on the human DG/CA3 subfield, these results may have clinical relevance for people receiving prescription corticosteroids, as well as to those with cortisol elevations due to medical or psychiatric conditions.",2019,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","['Men and women (N\u2009=\u200946) receiving chronic prescription corticosteroid therapy', 'humans receiving chronic corticosteroid therapy']","['NMDA receptor antagonist', 'placebo', 'memantine or placebo', 'memantine vs. placebo', 'memantine', 'corticosteroids']","['left DG/CA3 region', 'hippocampal subfield volume']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.420896,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","[{'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA. Sherwood.Brown@UTSouthwestern.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kulikova', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Van Enkevort', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Elena I', 'Initials': 'EI', 'LastName': 'Ivleva', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Yassa', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Changho', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Departments of Radiology and the Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Frol', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Khan', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Vazquez', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Malone', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0430-8']
378,32072866,Effects of a Video-based Intervention on Caregiver Confidence for Managing Dementia Care Challenges: Findings from the FamTechCare Clinical Trial.,"Objectives : The Supporting Family Caregivers with Technology trial tested the FamTechCare video support intervention against telephone support. Dementia caregivers' video-recorded challenging care encounters and an interdisciplinary team provided tailored feedback. This paper reports on the effects of the intervention on caregiver confidence in managing priority challenges, a secondary outcome of this non-blinded parallel randomized controlled trial. Methods : Caregiver/person living with dementia dyads were randomized to the experimental FamTechCare video support (n = 43) or attention control telephone support (n = 41) groups. Caregivers providing in-home care to a person living with mild or more severe dementia were eligible. Caregivers identified three priority challenges using the Caregiver Target Problems Questionnaire and rated the frequency and severity of each challenge and their confidence managing the challenge at baseline and 3-months. Challenges were classified using the FamTechCare Technology-supported Dementia Care Typology. Effects on confidence were compared between groups using the Wilcoxon rank-sum test and within groups using the Wilcoxon signed-rank test. Results : Caregiver priority challenges included managing dementia behaviors, understanding disease expectations, and performing activity of daily living care. Improvements were observed across the three categories in both groups; however, not all changes were statistically significant. No significant differences were identified between groups. Conclusion : Caregivers in the FamTechCare group reported benefit across all priority challenges including managing dementia behaviors, understanding disease expectations, and performing activity of daily living care. Clinical Implications : Innovative technology provides new opportunities to support family caregivers in dementia home care. Video-recording can be used to enhance support for family caregivers facing care challenges.",2020,"Improvements were observed across the three categories in both groups; however, not all changes were statistically significant.","['Caregiver/person living with dementia dyads', 'person living with mild or more severe dementia were eligible']","['FamTechCare video support intervention against telephone support', 'Video-based Intervention', 'FamTechCare', 'experimental FamTechCare video support (n\xa0=\xa043) or attention control telephone support']","['Caregiver Confidence', 'caregiver confidence']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C3494652', 'cui_str': 'Severe dementia (disorder)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}]",,0.0576217,"Improvements were observed across the three categories in both groups; however, not all changes were statistically significant.","[{'ForeName': 'Clarissa A', 'Initials': 'CA', 'LastName': 'Shaw', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Kristine N', 'Initials': 'KN', 'LastName': 'Williams', 'Affiliation': 'School of Nursing, University of Kansas, Kansas City, Kansas, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Perkhounkova', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'College of Nursing, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Carissa K', 'Initials': 'CK', 'LastName': 'Coleman', 'Affiliation': 'School of Nursing, University of Kansas, Kansas City, Kansas, USA.'}]",Clinical gerontologist,['10.1080/07317115.2020.1729917']
379,32078394,Randomized Trial of Academic Training and Medication Decision-Making for Adolescents with ADHD in Usual Care.,"Objective : This study tested two family-based interventions designed for delivery in usual care: Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA), containing motivational interventions, homework management and schoolwork organization training, and family-school partnership building; and Medication Integration Protocol (MIP), containing ADHD psychoeducation, medication decision-making, and integrated medication management. Method : This study used a cluster randomized design to test CASH-AA + MIP versus CASH-AA Only for adolescents with ADHD in five sites. Therapists (N = 49) were site clinicians randomized to condition. Clients (N = 145) included 72% males; 42% White Non-Hispanic, 37% Hispanic American, 15% African American, and 6% more than one race; average age was 14.8 years. Fidelity data confirmed protocol adherence and between-condition differentiation. Results : One-year improvements were observed across conditions in several outcomes. Overall, CASH-AA + MIP produced greater declines in adolescent-report inattentive symptoms and delinquent acts. Similarly, among non-substance users, CASH-AA + MIP clients attended more treatment sessions. In contrast, among substance users, CASH-AA Only clients showed greater declines in caregiver-report hyperactive symptoms and externalizing. Conclusions : This study provides initial experimental support for family-based ADHD medication decision-making when coupled with academic training in usual care. The treatment protocols, CASH-AA and MIP, showed positive effects in addressing not only ADHD symptoms but also common co-occurring problems, and youth with substance use problems benefitted along with non-using peers.",2020,"The treatment protocols, CASH-AA and MIP, showed positive effects in addressing not only ADHD symptoms but also common co-occurring problems, and youth with substance use problems benefitted along with non-using peers.","['Adolescents with ADHD in Usual Care', 'Clients (N = 145) included 72% males; 42% White Non-Hispanic, 37% Hispanic American, 15% African American, and 6% more than one race; average age was 14.8 years', 'Adolescents with ADHD (CASH-AA), containing', 'adolescents with ADHD in five sites']","['Academic Training and Medication Decision-Making', 'CASH-AA + MIP versus CASH-AA', 'motivational interventions, homework management and schoolwork organization training, and family-school partnership building; and Medication Integration Protocol (MIP), containing ADHD psychoeducation, medication decision-making, and integrated medication management']",['caregiver-report hyperactive symptoms and externalizing'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0019576', 'cui_str': 'Spanish Americans'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0000875', 'cui_str': 'Academic Training'}, {'cui': 'C0589414', 'cui_str': 'Homework, function (observable entity)'}, {'cui': 'C0220885', 'cui_str': 'organization'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}]","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",49.0,0.0278585,"The treatment protocols, CASH-AA and MIP, showed positive effects in addressing not only ADHD symptoms but also common co-occurring problems, and youth with substance use problems benefitted along with non-using peers.","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hogue', 'Affiliation': 'Center on Addiction.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Horan Fisher', 'Affiliation': 'Center on Addiction.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dauber', 'Affiliation': 'Center on Addiction.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Bobek', 'Affiliation': 'Center on Addiction.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Porter', 'Affiliation': 'Center on Addiction.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Henderson', 'Affiliation': 'Department of Psychology, Sam Houston State University.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Evans', 'Affiliation': 'Department of Psychology, Ohio University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2020.1716362']
380,32193729,Transgender Women's Experiences Using a Home HIV-Testing Kit for Partner-Testing.,"HIV partner-testing (PT) may represent a unique and empowering HIV prevention strategy for groups that face structural and institutional barriers to HIV testing and care, including transgender women. We report on in-depth interviews (IDIs) with N = 10 transgender women who used HIV self-test kits for three months to screen potential sexual partners in a randomized controlled trial (iSUM; ""I'll Show You Mine"") that took place in New York City and San Juan, Puerto Rico. Participants were assigned to intervention (supplied with 10 self-test kits immediately) or control groups (received 6 test kits after 3 months). We conducted IDIs with the first N = 10 transgender women to enroll in the intervention group after three months in the study (after participants used kits with partners) to understand their experiences. Themes discussed in IDIs included: partners' reaction to HIV testing, participants' reactions to partners' test results or refusal to test, partners' own reaction to their test results, and decision-making around test use. Data were independently analyzed by two coders. Overwhelmingly, participants' experiences with PT was positive. Participants reported kits were convenient and acceptable to most partners. Transgender women felt that PT could pose additional risk for them; one woman experienced violence related to kit use. Furthermore, the availability of kits appeared to encourage participants and their partners to think about their HIV status and, in some cases, modify sexual behavior. Work suggests that HIV PT could be a viable risk-reduction strategy for transgender women.",2020,Participants were assigned to intervention (supplied with 10 self-test kits immediately) or control groups (received 6 test kits after 3 months).,"['10 transgender women who used HIV self-test kits for three months to screen potential sexual partners', ""Transgender Women's Experiences Using a Home HIV-Testing Kit for Partner-Testing""]",['HIV partner-testing (PT'],[],"[{'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]",[],10.0,0.0227863,Participants were assigned to intervention (supplied with 10 self-test kits immediately) or control groups (received 6 test kits after 3 months).,"[{'ForeName': 'Christine Tagliaferri', 'Initials': 'CT', 'LastName': 'Rael', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA. Cr2857@cumc.columbia.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez-Rios', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sheinfil', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Frasca', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Catherine Cruz', 'Initials': 'CC', 'LastName': 'Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico, USA.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, School of Medicine, Center for Vulnerable Populations at Zuckerberg San Francisco General Hospital and Trauma Center, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Iribarren', 'Affiliation': 'School of Nursing, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Cheng-Shiun', 'Initials': 'CS', 'LastName': 'Leu', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, Puerto Rico, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies at the New York State Psychiatric Institute and Columbia University, 1051 Riverside Dr, New York, NY, 10032, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02829-x']
381,32243885,A High-Definition tDCS and EEG study on attention and vigilance: Brain stimulation mitigates the executive but not the arousal vigilance decrement.,"Attention comprises a wide set of processes such as phasic alertness, orienting, executive control, and the executive (i.e., detecting infrequent targets) and arousal (i.e., sustaining a fast reaction) vigilance components. Importantly, the effects of transcranial direct current stimulation (tDCS) over attentional functioning have been mostly addressed by measuring these processes separately and by delivering offline tDCS with low precision over the stimulation region. In the current study, we examined the effects of online High-Definition tDCS (HD-tDCS) over the behavioral and electrophysiological functioning of attentional and vigilance components. Participants (N = 92) were randomly assigned to one of three stimulation groups: right dorsolateral prefrontal cortex stimulation, right posterior parietal cortex (PPC) stimulation, and sham. All of them performed - in combination with the HD-tDCS protocol - an attentional networks task (ANTI-Vea) suitable to measure the executive and arousal components of vigilance along with three typical attentional functions: phasic alertness, orienting, and executive control. In addition, EEG was registered at the baseline and at the post-stimulation period. We observed that, regardless the stimulation region, online HD-tDCS: (a) reduced phasic alertness (p = .008), but did not modulated the orienting and executive control functioning; and (b) mitigated the executive vigilance decrement (p = .011), but did not modulated arousal vigilance across time-on-task. Interestingly, only HD-tDCS over PPC reduced considerably the increment of alpha power observed across time-on-task (p = .009). The current study provides further evidence for both an empirical dissociation between vigilance components and the cortical regions underlying attentional processes. We highlight the advantages of using online HD-tDCS to examine the stimulation effects on attentional and vigilance functioning.",2020,"We observed that, regardless the stimulation region, online HD-tDCS: (a) reduced phasic alertness (p = .008), but did not modulated the orienting and executive control functioning; and (b) mitigated the executive vigilance decrement (p = .011), but did not modulated arousal vigilance across time-on-task.",['Participants (N\u202f=\u202f92'],"['right dorsolateral prefrontal cortex stimulation, right posterior parietal cortex (PPC) stimulation, and sham', 'transcranial direct current stimulation (tDCS', 'online High-Definition tDCS (HD-tDCS']","['arousal vigilance', 'attention and vigilance', 'attentional and vigilance functioning', 'executive vigilance decrement', 'phasic alertness']",[],"[{'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0456855', 'cui_str': 'Right posterior'}, {'cui': 'C0030560', 'cui_str': 'Parietal lobe structure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539107', 'cui_str': 'Definition'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",92.0,0.0261973,"We observed that, regardless the stimulation region, online HD-tDCS: (a) reduced phasic alertness (p = .008), but did not modulated the orienting and executive control functioning; and (b) mitigated the executive vigilance decrement (p = .011), but did not modulated arousal vigilance across time-on-task.","[{'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Luna', 'Affiliation': 'Instituto de Investigaciones Psicológicas (IIPsi), CONICET-UNC. Facultad de Psicología, Universidad Nacional de Córdoba, Boulevard de la Reforma esquina Enfermera Gordillo, CP, 5000, Córdoba, Argentina(1); Department of Experimental Psychology, and Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Campus de Cartuja S/N, CP, 18011, Granada, Spain. Electronic address: fluna@unc.edu.ar.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Román-Caballero', 'Affiliation': 'Department of Experimental Psychology, and Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Campus de Cartuja S/N, CP, 18011, Granada, Spain. Electronic address: rrarroca@ugr.es.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Barttfeld', 'Affiliation': 'Instituto de Investigaciones Psicológicas (IIPsi), CONICET-UNC. Facultad de Psicología, Universidad Nacional de Córdoba, Boulevard de la Reforma esquina Enfermera Gordillo, CP, 5000, Córdoba, Argentina(1). Electronic address: pablob@conicet.gov.ar.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Lupiáñez', 'Affiliation': 'Department of Experimental Psychology, and Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Campus de Cartuja S/N, CP, 18011, Granada, Spain. Electronic address: jlupiane@ugr.es.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Martín-Arévalo', 'Affiliation': 'Department of Experimental Psychology, and Mind, Brain, and Behavior Research Center (CIMCYC), University of Granada, Campus de Cartuja S/N, CP, 18011, Granada, Spain. Electronic address: emartina@ugr.es.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107447']
382,31633789,Opioid Exposure Negatively Affects Antidepressant Response to Venlafaxine in Older Adults with Chronic Low Back Pain and Depression.,"OBJECTIVE


Serotonin norepinephrine reuptake inhibitors (SNRIs) are commonly co-prescribed with opioids for chronic pain. The purpose of this study was to describe pain and mood response to venlafaxine among older adults with chronic low back pain (CLBP) and depression relative to opioid exposure.
DESIGN


Secondary analyses were collected from a randomized clinical trial testing a stepped-care approach to comorbid pain and depression in older patients: the Addressing Depression and Pain Together study (ADAPT: 2010-2016).
SETTING


University-based late-life mental health research clinic.
SUBJECTS


Two hundred twenty-seven adults aged 65+ years with CLBP and depression.
METHODS


Participants received six weeks of lower-dose venlafaxine (≤150 mg/d). Pain and depression were measured each week. Response for both pain and depression at the end of six weeks was defined by a ≥30% improvement on a 0-20 numeric rating scale for low back pain and a Patient Health Questionnaire-9 score ≤5. Opioid exposure was analyzed as prescribed (yes or no) and by morphine equivalent dosing (MED).
RESULTS


Patients co-prescribed an opioid were less likely to report a pain response to venlafaxine. MED was negatively correlated with pain response. Depression response was not impacted.
CONCLUSIONS


Opioids are negatively associated with older adults' early analgesic response to lower-dose venlafaxine. These findings suggest that clinicians may wish to consider either nonopioid or alternative antidepressant approaches to pain management in these complex patients. It is reassuring that opioids do not prevent depression response. Future research should examine both longer duration of treatment and a wider range of doses.",2020,"Depression response was not impacted.
","['Two hundred twenty-seven adults aged 65+ years with CLBP and depression', 'Older Adults with Chronic Low Back Pain and Depression', 'older adults with chronic low back pain (CLBP) and depression relative to opioid exposure', 'University-based late-life mental health research clinic', 'older patients']","['Serotonin norepinephrine reuptake inhibitors (SNRIs', 'venlafaxine', 'nonopioid', 'morphine equivalent dosing (MED', 'stepped-care approach', 'Venlafaxine']","['pain and mood response', 'analgesic response', 'pain response', 'Pain and depression', 'Depression response']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0035168'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C4521489', 'cui_str': 'Norepinephrine reuptake inhibitor (disposition)'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",227.0,0.102578,"Depression response was not impacted.
","[{'ForeName': 'Sarah T', 'Initials': 'ST', 'LastName': 'Stahl', 'Affiliation': 'Departments of Psychiatry.'}, {'ForeName': 'Changgi', 'Initials': 'C', 'LastName': 'Jung', 'Affiliation': 'Departments of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Weiner', 'Affiliation': 'Departments of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Peciña', 'Affiliation': 'Departments of Psychiatry.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Departments of Psychiatry.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz279']
383,32199736,A home-based exercise program focused on proprioception to reduce falls in frail and pre-frail community-dwelling older adults.,"Frailty and falls are closely associated with each other as well as with disability, hospitalization, and death. Exercise can reduce these risks in both robust and frail older people. This before-after, non-randomized intervention study assessed a one-year proprioception training program with individual daily home exercises in 564 community-dwelling people aged 70 years and over, with different frailty phenotypes. After the exercise program, we observed a moderate reduction in the mean number of falls, fear of falls, body mass index and body fat percentage in frail and pre-frail participants. These results suggest that a home proprioception program may be a viable alternative to complex multicomponent exercise programs in settings where these are not feasible, since home proprioception can reach a larger population at a lower cost, and it affords clear benefits.",2020,"After the exercise program, we observed a moderate reduction in the mean number of falls, fear of falls, body mass index and body fat percentage in frail and pre-frail participants.","['frail older people', 'frail and pre-frail community-dwelling older adults', '564 community-dwelling people aged 70 years and over, with different frailty phenotypes']","['home-based exercise program', 'proprioception training program with individual daily home exercises', 'Exercise']","['mean number of falls, fear of falls, body mass index and body fat percentage']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0575126', 'cui_str': 'Falls occurrence'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}]",564.0,0.0126978,"After the exercise program, we observed a moderate reduction in the mean number of falls, fear of falls, body mass index and body fat percentage in frail and pre-frail participants.","[{'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Pérez-Ros', 'Affiliation': 'Department of Nursing, Universidad Católica de Valencia San Vicente Mártir, 46007 Valencia, Spain; Frailty and Cognitive Impairment Research Group (FROG), University of Valencia, 46010 Valencia, Spain. Electronic address: pilar.perez@ucv.es.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Vila-Candel', 'Affiliation': 'Department of Nursing, Universidad Católica de Valencia San Vicente Mártir, 46007 Valencia, Spain; Department of Obstetrics and Gynaecology, Hospital Universitario de la Ribera, FISABIO. Crtra. Corbera km 1, 46600 Valencia, Spain; Department of Nursing, Faculty of Nursing and Podiatry, Universitat de València, Jaume Roig, s/n, 46010 Valencia, Spain.'}, {'ForeName': 'Francisco Miguel', 'Initials': 'FM', 'LastName': 'Martínez-Arnau', 'Affiliation': 'Department of Nursing, Universidad Católica de Valencia San Vicente Mártir, 46007 Valencia, Spain; Frailty and Cognitive Impairment Research Group (FROG), University of Valencia, 46010 Valencia, Spain; Department of Physiotherapy, Universitat de València, 46010 Valencia, Spain.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.01.017']
384,32036587,"Evaluation of the Efficacy of BI 425809 Pharmacotherapy in Patients with Schizophrenia Receiving Computerized Cognitive Training: Methodology for a Double-blind, Randomized, Parallel-group Trial.","BACKGROUND AND OBJECTIVE: Cognitive impairments associated with schizophrenia (CIAS) predict poor functional outcomes, but there are currently no approved pharmacological treatments for patients with CIAS. Additional cognitive stimulation may be required for pro-cognitive medications to improve efficacy, and computerized cognitive training (CCT) can be used to increase cognitive activity. A trial evaluating the effects of the novel glycine transporter inhibitor BI 425809 compared with placebo, on a background of regularly self-administered CCT in clinically stable patients with schizophrenia has commenced and its methodology is described here.
METHODS


This Phase II, multinational, randomized, double-blind, placebo-controlled, parallel-group trial will randomize 200 clinically stable outpatients, aged 18-50 years with established schizophrenia and no other major psychiatric disorder, 1:1 to BI 425809 or placebo once daily for 12 weeks. Following screening, which included a 2-week CCT run-in period, patients sufficiently compliant with CCT (target: ≥ 2 h of CCT per week during CCT run-in) will be randomized. During the 12-week treatment period, all patients should complete a total of approximately 30 h of CCT. The primary endpoint is change from baseline in neurocognitive function as measured by the neurocognitive composite score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB), after 12 weeks of treatment. Secondary endpoints include change from baseline in overall MCCB score, Schizophrenia Cognition Rating Scale, Positive and Negative Syndrome Scale, and safety (adverse events [AEs]) and serious AEs. Primary and secondary endpoints will be analyzed using the Restricted Maximum Likelihood-based mixed model for repeated measures. Novel endpoints include the Balloon Effort Task to evaluate patients' motivation and the Virtual Reality Functional Capacity Assessment Tool to assess skills for daily functioning.
DISCUSSION


This is one of the largest and longest trials to date to combine pharmacological therapy with CCT in patients with schizophrenia and will determine the benefit of combining BI 425809 pharmacotherapy with cognitive stimulation through self-administered CCT. This trial will further evaluate whether improvements in neurocognition translate into improved everyday functioning, whether self-administered CCT can be effectively implemented in a large multinational trial, and the role of motivation in neurocognitive and functional improvements.
TRIAL REGISTRATION


Registered on Clinicaltrials.gov on March 1, 2019 (NCT03859973).",2020,"Secondary endpoints include change from baseline in overall MCCB score, Schizophrenia Cognition Rating Scale, Positive and Negative Syndrome Scale, and safety (adverse events [AEs]) and serious AEs.","['patients with schizophrenia', 'clinically stable patients with schizophrenia', 'Patients with Schizophrenia Receiving Computerized Cognitive Training', '200 clinically stable outpatients, aged 18-50\xa0years with established schizophrenia and no other major psychiatric disorder, 1:1 to BI\xa0425809 or placebo once daily for 12\xa0weeks', 'patients with CIAS']","['computerized cognitive training (CCT', 'BI 425809 Pharmacotherapy', 'placebo', 'novel glycine transporter inhibitor BI\xa0425809 compared with placebo', 'CCT']","['neurocognitive composite score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB', 'change from baseline in overall MCCB score, Schizophrenia Cognition Rating Scale, Positive and Negative Syndrome Scale, and safety (adverse events [AEs]) and serious AEs', 'change from baseline in neurocognitive function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061609', 'cui_str': 'Glycine Plasma Membrane Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0035168'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0222045'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031843', 'cui_str': 'function'}]",425809.0,0.436282,"Secondary endpoints include change from baseline in overall MCCB score, Schizophrenia Cognition Rating Scale, Positive and Negative Syndrome Scale, and safety (adverse events [AEs]) and serious AEs.","[{'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Harvey', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA. pharvey@med.miami.edu.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bowie', 'Affiliation': ""Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'McDonald', 'Affiliation': 'Boehringer Ingelheim (Canada) Ltd, Burlington, ON, Canada.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Podhorna', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim-am-Rhein, Germany.'}]",Clinical drug investigation,['10.1007/s40261-020-00893-8']
385,32172522,Neuroprotective Role of Oral Vitamin D Supplementation on Consciousness and Inflammatory Biomarkers in Determining Severity Outcome in Acute Traumatic Brain Injury Patients: A Double-Blind Randomized Clinical Trial.,"BACKGROUND AND OBJECTIVE


Early management of traumatic brain injury (TBI) is essential. We aimed to evaluate the efficacy of vitamin D over early clinical outcome and serum cytokine levels in patients with moderate to severe brain injury.
METHODS


Thirty-five patients with moderate to severe traumatic brain injury who were admitted to the ICU unit were recruited into the study. Subjects were randomly allocated to a treatment regimen comprising either a one-time oral dose of 120,000 IU (two tablets of 60,000 IU each) of vitamin D (n = 20) or 8 mg of saccharide (two tablets of 4 g each) as placebo (n = 15). The main parameters evaluated included duration of mechanical ventilation and ICU stay, Glasgow Coma Scale (GCS) and cytokine levels (interleukin (IL)-6, tumour necrosis factor (TNF)-α, interferon (IFN)-γ, IL-2).
RESULTS


The results indicated an improvement in the level of consciousness after 7 days in the vitamin D-treated group compared with placebo. An elevation in GCS score by 3.86 units in the vitamin D-treated group with a 0.19-unit descent in the control group was recorded. Duration of mechanical ventilation was reduced in the vitamin D-treated group compared with the control group (4.7 days vs. 8.2 days, p value 0.0001). A noticeable reduction was recorded in inflammatory biomarkers (cytokines) in the vitamin D-treated group (IL-6 p = 0.08, TNF-α p = 0.02, IL-2 p = 0.36) with notable elevation in IFN-γ (p = 0.65) compared to the control group.
CONCLUSION


In the acute phase of moderate to severe traumatic brain injury, vitamin D supplementation plays a vital role and has a favourable effect on the consciousness level of patients. Clinical trial Registry (CTRI) No. CTRI/2019/05/019259.",2020,The results indicated an improvement in the level of consciousness after 7 days in the vitamin D-treated group compared with placebo.,"['Acute Traumatic Brain Injury Patients', 'patients with moderate to severe brain injury', 'Thirty-five patients with moderate to severe traumatic brain injury who were admitted to the ICU unit were recruited into the study']","['saccharide', 'vitamin D', 'placebo', 'vitamin D supplementation', 'Oral Vitamin D Supplementation']","['level of consciousness', 'duration of mechanical ventilation and ICU stay, Glasgow Coma Scale (GCS) and cytokine levels (interleukin (IL)-6, tumour necrosis factor (TNF)-α, interferon (IFN)-γ, IL-2', 'Duration of mechanical ventilation', 'GCS score', 'IFN-γ', 'Consciousness and Inflammatory Biomarkers', 'inflammatory biomarkers (cytokines', 'serum cytokine levels']","[{'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0007004', 'cui_str': 'Carbohydrates'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0234425', 'cui_str': 'Level of consciousness (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",35.0,0.333212,The results indicated an improvement in the level of consciousness after 7 days in the vitamin D-treated group compared with placebo.,"[{'ForeName': 'Swapnil', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Pharmacy, Banasthali Vidyapith, Banasthali, 304022, Rajasthan, India.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Pharmacy, Banasthali Vidyapith, Banasthali, 304022, Rajasthan, India.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Choudhary', 'Affiliation': 'Department of Neurosurgery, PGIMER, Dr. R.M.L. Hospital, New Delhi, 110001, India. ajay7.choudhary@gmail.com.'}, {'ForeName': 'Shallu', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Pharmacy, Banasthali Vidyapith, Banasthali, 304022, Rajasthan, India.'}, {'ForeName': 'Lipika', 'Initials': 'L', 'LastName': 'Khurana', 'Affiliation': 'Sir Ganga Ram Hospital, Institute of Obstetrics and Gynaecology, New Delhi, 110060, India.'}, {'ForeName': 'Neera', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Department of Biochemistry, PGIMER, Dr. R.M.L. Hospital, New Delhi, 110001, India.'}, {'ForeName': 'Vijender', 'Initials': 'V', 'LastName': 'Kumar', 'Affiliation': 'Department of Biochemistry, PGIMER, Dr. R.M.L. Hospital, New Delhi, 110001, India.'}, {'ForeName': 'Akansha', 'Initials': 'A', 'LastName': 'Bisht', 'Affiliation': 'Department of Pharmacy, Banasthali Vidyapith, Banasthali, 304022, Rajasthan, India.'}]",Clinical drug investigation,['10.1007/s40261-020-00896-5']
386,32126798,"Anxiety and apprehension in visual working memory performance: no change to capacity, but poorer distractor filtering.","BACKGROUND AND OBJECTIVES


Individual differences in acute and chronic anxiety have been linked to changes in working memory ability, though evidence for differences in specifically visual working memory performance has been inconsistent. The present study examined the role of both trait anxiety and induced feelings of apprehension on visual working memory performance.
DESIGN


2 (Noise) x 2 (Distraction) within-person design with anxiety as a between-person factor.
METHODS


Forty-six participants recruited via online advertisement completed a change detection task, memorizing the orientations of rectangular bars presented either alone or among additional distractors, comparing this to a subsequent test display. Trait anxiety levels were measured by self-report questionnaire. To induce apprehension, participants completed some experimental blocks where loud aversive white noise could be presented at low probability.
RESULTS


Results of ANOVA and ANCOVA models showed that neither trait anxiety nor apprehension affected memory performance when only relevant objects were shown. However, memory performance was impaired when distractor objects were presented, and this effect was exacerbated under apprehension particularly for high trait anxious individuals.
CONCLUSIONS


Results suggest that induced apprehension and trait anxiety have little influence on visual working memory capacity, instead primarily disrupting distractor filtering efficiency.",2020,"RESULTS


Results of ANOVA and ANCOVA models showed that neither trait anxiety nor apprehension affected memory performance when only relevant objects were shown.",['Forty-six participants recruited via'],"['online advertisement completed a change detection task, memorizing the orientations of rectangular bars presented either alone or among additional distractors']","['visual working memory capacity', 'Anxiety and apprehension in visual working memory performance', 'trait anxiety nor apprehension affected memory performance', 'Trait anxiety levels', 'memory performance']",[],"[{'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0205142', 'cui_str': 'Rectangular (qualifier value)'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233485', 'cui_str': 'Apprehension (finding)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C1285654', 'cui_str': 'Ability to remember'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}]",46.0,0.0464827,"RESULTS


Results of ANOVA and ANCOVA models showed that neither trait anxiety nor apprehension affected memory performance when only relevant objects were shown.","[{'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Berggren', 'Affiliation': 'Department of Psychological Sciences, Birkbeck College, University of London, London, UK.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1736899']
387,32160798,Evaluation of a brief cognitive behavioral group intervention to reduce depersonalization in students with high levels of trait test anxiety: a randomized controlled trial.,"Background and objectives:  Students with high levels of test anxiety frequently experience depersonalization during examinations. We investigated whether a brief cognitive behavioral group intervention reduces these symptoms. Design:  Randomized controlled trial. Methods:  Students with high levels of trait test anxiety and impairing depersonalization symptoms during their last oral examination were randomized. While the intervention group ( n  = 22) received a group training, a control group ( n  = 16) underwent an active waiting time protocol. Effects of the intervention on depersonalization severity and its appraisal, attention focus, emotion regulation, anxiety, heart rate, and heart rate variability within the Trier Social Stress Test for groups were examined. A follow-up assessment was conducted after a university oral examination. Registration number: DRKS00010190. Results:  Depersonalization and its appraisal significantly changed within the intervention group, but not within the control group. The intervention group reported significantly less self-focused attention and fear and used the coping strategy reappraisal significantly more often. No significant Group × Time interaction was detected regarding heart rate and heart rate variability. Follow-up results give a first indication of the reduction of depersonalization through the intervention in a naturalistic setting. Conclusion:  The intervention seems promising for treating depersonalization in students with high levels of trait test anxiety.",2020,Follow-up results give a first indication of the reduction of depersonalization through the intervention in a naturalistic setting.,"['students with high levels of trait test anxiety', 'Students with high levels of test anxiety frequently experience depersonalization during examinations', 'Students with high levels of trait test anxiety and impairing depersonalization symptoms during their last oral examination were randomized']","['control group ( n \u2009=\u200916) underwent an active waiting time protocol', 'cognitive behavioral group intervention']","['self-focused attention and fear and used the coping strategy reappraisal', 'depersonalization severity and its appraisal, attention focus, emotion regulation, anxiety, heart rate, and heart rate variability', 'heart rate and heart rate variability']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0011551', 'cui_str': 'Depersonalization'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376306', 'cui_str': 'Oral Examination'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0589098', 'cui_str': 'Focused attention, function (observable entity)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0011551', 'cui_str': 'Depersonalization'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",,0.0565944,Follow-up results give a first indication of the reduction of depersonalization through the intervention in a naturalistic setting.,"[{'ForeName': 'Tabea L K', 'Initials': 'TLK', 'LastName': 'Schweden', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Annika C', 'Initials': 'AC', 'LastName': 'Konrad', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Magdalena K', 'Initials': 'MK', 'LastName': 'Wekenborg', 'Affiliation': 'Department of Biological Psychology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Hoyer', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1736936']
388,31597320,Allogenic Faecal Microbiota Transfer Induces Immune-Related Gene Sets in the Colon Mucosa of Patients with Irritable Bowel Syndrome.,"Faecal microbiota transfer (FMT) consists of the introduction of new microbial communities into the intestine of a patient, with the aim of restoring a disturbed gut microbiota. Even though it is used as a potential treatment for various diseases, it is unknown how the host mucosa responds to FMT. This study aims to investigate the colonic mucosa gene expression response to allogenic (from a donor) or autologous (own) FMT in patients with irritable bowel syndrome (IBS). In a recently conducted randomised, double-blinded, controlled clinical study, 17 IBS patients were treated with FMT by colonoscopy. RNA was isolated from colonic biopsies collected by sigmoidoscopy at baseline, as well as two weeks and eight weeks after FMT. In patients treated with allogenic FMT, predominantly immune response-related gene sets were induced, with the strongest response two weeks after the FMT. In patients treated with autologous FMT, predominantly metabolism-related gene sets were affected. Furthermore, several microbiota genera showed correlations with immune-related gene sets, with different correlations found after allogenic compared to autologous FMT. This study shows that the microbe-host response is influenced by FMT on the mucosal gene expression level, and that there are clear differences in response to allogenic compared to autologous FMT.",2019,"In patients treated with allogenic FMT, predominantly immune response-related gene sets were induced, with the strongest response two weeks after the FMT.","['patients with irritable bowel syndrome (IBS', '17 IBS patients', 'Patients with Irritable Bowel Syndrome']","['Allogenic Faecal Microbiota Transfer Induces Immune-Related Gene Sets', 'allogenic FMT', 'autologous FMT', 'FMT by colonoscopy', 'allogenic (from a donor) or autologous (own) FMT', 'Faecal microbiota transfer (FMT', 'FMT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]",[],17.0,0.032539,"In patients treated with allogenic FMT, predominantly immune response-related gene sets were induced, with the strongest response two weeks after the FMT.","[{'ForeName': 'Savanne', 'Initials': 'S', 'LastName': 'Holster', 'Affiliation': 'Nutrition-Gut-Brain Interactions Research Centre, Faculty of Health and Medicine, School of Medical Sciences, Örebro University, 701 82 Örebro, Sweden.'}, {'ForeName': 'Guido J', 'Initials': 'GJ', 'LastName': 'Hooiveld', 'Affiliation': 'Nutrition, Metabolism and Genomics group, Division of Human Nutrition and Health, Wageningen University, 6708 PB Wageningen, The Netherlands.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Repsilber', 'Affiliation': 'Nutrition-Gut-Brain Interactions Research Centre, Faculty of Health and Medicine, School of Medical Sciences, Örebro University, 701 82 Örebro, Sweden.'}, {'ForeName': 'Willem M de', 'Initials': 'WM', 'LastName': 'Vos', 'Affiliation': 'Laboratory of Microbiology, Wageningen University and Research Centre, 6708 PB Wageningen, The Netherlands.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Brummer', 'Affiliation': 'Nutrition-Gut-Brain Interactions Research Centre, Faculty of Health and Medicine, School of Medical Sciences, Örebro University, 701 82 Örebro, Sweden.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'König', 'Affiliation': 'Nutrition-Gut-Brain Interactions Research Centre, Faculty of Health and Medicine, School of Medical Sciences, Örebro University, 701 82 Örebro, Sweden. julia.konig@oru.se.'}]",Biomolecules,['10.3390/biom9100586']
389,31203212,Dissociation Between Clinical Benefit and Persistent Urate Lowering in Patients with Chronic Refractory Gout Treated with Pegloticase.,"OBJECTIVE


To assess clinical benefit in patients with chronic refractory gout who did not meet the protocol-defined criteria of responders to pegloticase.
METHODS


This analysis used results from 2 randomized controlled trials (ClinicalTrials.gov: NCT00325195, NCT01356498) to assess the clinical efficacy in responders and nonresponders to treatment (8 mg of pegloticase every 2 weeks). Serum urate was measured before each infusion and the following were recorded: assessment of gout flares, tophus reduction, patient's global assessment (PtGA), tender and swollen joints (TJC and SJC), pain using a 100-mm visual analog scale, and a variety of patient-reported outcomes [Medical Outcomes Study Short Form-36 questionnaire physical component summary score and arthritis-specific health index (ASHI) score].
RESULTS


The analysis included 36 persistent urate responders, 49 nonresponders, and 43 patients who received placebo. Results for both responders and nonresponders indicated significant reduction in tophi and improvements from baseline in PtGA, TJC, SJC, pain, and ASHI. No significant improvements were observed in the patients who received placebo.
CONCLUSION


Chronic refractory gout patients not achieving protocol-defined persistent urate lowering still achieve significant clinical benefits with pegloticase treatment, suggesting that transient reduction in serum urate may result in sustained clinical benefit.",2020,"Results for both responders and nonresponders indicated significant reduction in tophi and improvements from baseline in PGA, TJC, SJC, pain, and ASHIS.","['36 persistent urate responders, 49 nonresponders, and 43 patients who received', 'patients with chronic refractory gout who did not meet the protocol-defined criteria of responders to pegloticase', 'Patients with Chronic Refractory Gout Treated with Pegloticase']",['placebo'],"['gout flares, tophus reduction, Patient Global Assessment (PGA), tender and swollen joints (TJC and SJC), pain measured with a 100-mm visual analog scale (VAS) and a variety of patient reported outcomes (36-Item Short Form Health Survey ', 'Serum urate', 'SF-36) Physical Component Score [PCS] and Arthritis-Specific Health Index Score [ASHIS', 'PGA, TJC, SJC, pain, and ASHIS']","[{'cui': 'C0935936', 'cui_str': 'Urate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2350656', 'cui_str': 'PEG-uricase'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1619733', 'cui_str': 'Gout flare'}, {'cui': 'C0221248', 'cui_str': 'Tophus (morphologic abnormality)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C0152031', 'cui_str': 'Joint swelling (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0935936', 'cui_str': 'Urate'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}]",36.0,0.250224,"Results for both responders and nonresponders indicated significant reduction in tophi and improvements from baseline in PGA, TJC, SJC, pain, and ASHIS.","[{'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Pillinger', 'Affiliation': 'From the NYU Langone Medical Center, New York; Hospital for Special Surgery, New York, New York; Horizon Therapeutics, Lake Forest, Illinois; AMPEL BioSolutions LLC, Charlottesville, Virginia, USA.'}, {'ForeName': 'Theodore R', 'Initials': 'TR', 'LastName': 'Fields', 'Affiliation': 'From the NYU Langone Medical Center, New York; Hospital for Special Surgery, New York, New York; Horizon Therapeutics, Lake Forest, Illinois; AMPEL BioSolutions LLC, Charlottesville, Virginia, USA.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Yeo', 'Affiliation': 'From the NYU Langone Medical Center, New York; Hospital for Special Surgery, New York, New York; Horizon Therapeutics, Lake Forest, Illinois; AMPEL BioSolutions LLC, Charlottesville, Virginia, USA.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Lipsky', 'Affiliation': 'From the NYU Langone Medical Center, New York; Hospital for Special Surgery, New York, New York; Horizon Therapeutics, Lake Forest, Illinois; AMPEL BioSolutions LLC, Charlottesville, Virginia, USA.'}]",The Journal of rheumatology,['10.3899/jrheum.190161']
390,32237279,"A new model of care and in-house general practitioners for residential aged care facilities: a stepped wedge, cluster randomised trial.","OBJECTIVES


To evaluate whether an alternative model of care in aged care facilities, including in-house general practitioners, influenced health outcomes for residents.
DESIGN


Stepped wedge, cluster randomised controlled trial over 90 weeks (31 December 2012 - 21 September 2014), with a 54-week pre-trial retrospective data period (start: 19 December 2011) and a 54-week post-trial prospective data collection period (to 4 October 2015).
PARTICIPANTS, SETTING


Fifteen residential aged care facilities operated by Bupa Aged Care in metropolitan and regional cities in four Australian states.
INTERVENTION


Residential aged care facilities sought to recruit general practitioners as staff members; care staff roles were redefined to allow registered nurses greater involvement in care plan development.
MAIN (PRIMARY) OUTCOME MEASURES


Numbers of falls; numbers of unplanned transfers to hospital; polypharmacy.
RESULTS


The new model of care could be implemented in all facilities, but four could not recruit in-house GPs at any time during the trial period. Intention-to-treat analyses found no statistically significant effect of the intervention on the primary outcome measures. Contamination-adjusted intention-to-treat analyses identified that the presence of an in-house GP was associated with reductions in the numbers of unplanned hospital transfers (incidence rate ratio [IRR], 0.53; 95% CI, 0.43-0.66) and admissions (IRR, 0.52; 95% CI, 0.41-0.64) and of out-of-hours GP call-outs (IRR, 0.54; 95% CI, 0.36-0.80), but also with an increase in the number of reported falls (IRR, 1.37; 95% CI, 1.20-1.58).
CONCLUSIONS


Recruiting GPs to work directly in residential aged care facilities is difficult, but may reduce the burden of unplanned presentations to hospitals and increase the reporting of adverse events.
TRIAL REGISTRATION


Australia New Zealand Clinical Trial Registry, ACTRN12613000218796 (25 February 2013).",2020,"Contamination-adjusted intention-to-treat analyses identified that the presence of an in-house GP was associated with reductions in the numbers of unplanned hospital transfers (incidence rate ratio [IRR], 0.53; 95% CI, 0.43-0.66) and admissions (IRR, 0.52; 95% CI, 0.41-0.64) and of out-of-hours GP call-outs (IRR, 0.54; 95% CI, 0.36-0.80), but also with an increase in the number of reported falls (IRR, 1.37; 95% CI, 1.20-1.58).
","['90 weeks (31 December 2012 - 21 September 2014), with a 54-week pre-trial retrospective data period (start: 19 December 2011) and a 54-week post-trial prospective data collection period (to 4 October 2015', 'Fifteen residential aged care facilities operated by Bupa Aged Care in metropolitan and regional cities in four Australian states', 'residential aged care facilities', 'house general practitioners for residential aged care facilities', 'aged care facilities, including in-house general practitioners, influenced health outcomes for residents']",['Residential aged care facilities sought to recruit general practitioners as staff members; care staff roles were redefined to allow registered nurses greater involvement in care plan development'],"['Numbers of falls; numbers of unplanned transfers to hospital; polypharmacy', 'numbers of unplanned hospital transfers']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}]",,0.299138,"Contamination-adjusted intention-to-treat analyses identified that the presence of an in-house GP was associated with reductions in the numbers of unplanned hospital transfers (incidence rate ratio [IRR], 0.53; 95% CI, 0.43-0.66) and admissions (IRR, 0.52; 95% CI, 0.41-0.64) and of out-of-hours GP call-outs (IRR, 0.54; 95% CI, 0.36-0.80), but also with an increase in the number of reported falls (IRR, 1.37; 95% CI, 1.20-1.58).
","[{'ForeName': 'Terry P', 'Initials': 'TP', 'LastName': 'Haines', 'Affiliation': 'Monash University, Melbourne, VIC.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Palmer', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Tierney', 'Affiliation': 'Bupa Aged Care Australia, Sydney, NSW.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Si', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Robinson', 'Affiliation': 'Wicking Dementia Research and Education Centre, University of Tasmania, Hobart, TAS.'}]",The Medical journal of Australia,['10.5694/mja2.50565']
391,32237024,"Antenatal magnesium sulphate for the prevention of cerebral palsy in infants born preterm: a double-blind, randomised, placebo-controlled, multi-centre trial.","OBJECTIVE


To study the effect of antenatal magnesium sulphate (MgSO 4  ) on cerebral palsy (CP) in a manner that also provides adequate power for a linked trial sequential analysis.
DESIGN


Double-blind, randomised, placebo-controlled, multi-centre trial.
SETTING


Fourteen Danish obstetric departments.
POPULATION


In total, 560 pregnant women at risk for preterm delivery before 32 weeks of gestation were randomised from December 2011 to January 2018. Those women gave birth to 680 children.
METHODS


Women were randomised to receive either a loading dose of 5 g MgSO 4  followed by 1 g/hour or a placebo in identical volumes. The children were followed up at a corrected age of 18 months or older with a review of their medical charts and with the Ages and Stages Questionnaire.
MAIN OUTCOME MEASURE


The primary outcome measure was moderate to severe CP. Secondary outcomes included mortality, neonatal morbidity, blindness and mild CP.
RESULTS


The crude rates of moderate to severe CP in the MgSO 4  group and the placebo group were 2.0% and 3.3%, respectively. The adjusted odds of moderate to severe CP were lower in the MgSO 4  group than in the placebo group (odds ratio 0.61; 95% CI 0.23-1.65).
CONCLUSIONS


Antenatal MgSO 4  before 32 weeks of gestation decreases the likelihood of moderate to severe CP; these results are entirely consistent with other randomised evidence summarised in the linked trial sequential analysis.
TWEETABLE ABSTRACT


Antenatal magnesium sulphate may decrease the risk of moderate to severe cerebral palsy in children born before 32 weeks of gestation.",2020,"The adjusted odds of moderate to severe CP were lower in the MgSO 4  group than in the placebo group (odds ratio 0.61; 95% confidence interval 0.23-1.65).
","['Women', 'Those women gave birth to 680 children', '560 pregnant women at risk for preterm delivery before 32 weeks of gestation were randomised from December 2011 to January 2018', 'children were followed up at a corrected age of 18 months or older with a review of their medical charts and with the Ages and Stages Questionnaire', 'infants born preterm', 'Fourteen Danish obstetric departments']","['antenatal magnesium sulphate (MgSO 4  ', 'placebo', 'Antenatal magnesium sulphate']","['crude rates of moderate to severe CP', 'cerebral palsy (CP', 'cerebral palsy', 'adjusted odds of moderate to severe CP', 'moderate to severe CP', 'mortality, neonatal morbidity, blindness, and mild CP']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0028775', 'cui_str': 'Obstetrics department'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]",560.0,0.7697,"The adjusted odds of moderate to severe CP were lower in the MgSO 4  group than in the placebo group (odds ratio 0.61; 95% confidence interval 0.23-1.65).
","[{'ForeName': 'H T', 'Initials': 'HT', 'LastName': 'Wolf', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Brok', 'Affiliation': 'Department of Paediatric and Adolescent Medicine, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Henriksen', 'Affiliation': 'Department of Paediatrics (Intensive Care Neonatology), Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Greisen', 'Affiliation': 'Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Salvig', 'Affiliation': 'Department of Obstetrics and Gynecology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Pryds', 'Affiliation': 'Department of Paediatrics, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hedegaard', 'Affiliation': 'Klinik Hedegaard, Copenhagen, Denmark.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Weber', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Hegaard', 'Affiliation': 'Department of Obstetrics and Gynaecology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'L D', 'Initials': 'LD', 'LastName': 'Huusom', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16239']
392,31443627,Examination of a Subgroup of Patients With Chronic Low Back Pain Likely to Benefit More From Pilates-Based Exercises Compared to an Educational Booklet.,"OBJECTIVE


To investigate whether 2 previously published classification approaches, the updated treatment-based classification system and a Pilates subgroup defined by a preliminary clinical prediction rule, could identify patients with chronic low back pain who would benefit more from Pilates exercises compared to an educational booklet.
DESIGN


Secondary analysis of a randomized controlled trial.
METHODS


Two hundred twenty-two patients received advice and were randomly allocated to a group that received an educational booklet with no additional treatment (n = 74) or a group that received Pilates-based exercise treatment (n = 148) 2 or 3 times a week. At baseline, using a treatment-based classification system, patients were classified as having a good prognosis (positive movement control) or a poor prognosis. Similarly, using the Pilates clinical prediction rule, patients were classified as having a good prognosis (positive) or a poor prognosis (negative). The analysis was conducted using linear regression models to analyze the interaction between subgroup characteristics and treatment effect size, with changes in pain and disability from baseline to 6 weeks after randomization as dependent variables.
RESULTS


None of the interaction terms for pain and disability were statistically significant. The treatment effect of Pilates versus an educational booklet was similar in all subgroups.
CONCLUSION


The treatment-based classification system and the Pilates clinical prediction rule did not differentiate subgroups of patients with chronic low back pain who were more or less likely to benefit more from Pilates compared to an educational booklet.  J Orthop Sports Phys Ther 2020;50(4):189-197. Epub 23 Aug 2019. doi:10.2519/jospt.2019.8839 .",2020,None of the interaction terms for pain and disability were statistically significant.,"['chronic low back pain (LBP', 'patients with LBP who benefit more from Pilates compared to an educational booklet', '222 patients received advice']",['educational booklet group who did not receive additional treatment (n=74) or a Pilates group'],['pain and disability'],"[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",222.0,0.123893,None of the interaction terms for pain and disability were statistically significant.,"[{'ForeName': 'Diego Diulgeroglo Vicco', 'Initials': 'DDV', 'LastName': 'Amaral', 'Affiliation': ''}, {'ForeName': 'Gisela Cristiane', 'Initials': 'GC', 'LastName': 'Miyamoto', 'Affiliation': ''}, {'ForeName': 'Katherinne Ferro Moura', 'Initials': 'KFM', 'LastName': 'Franco', 'Affiliation': ''}, {'ForeName': 'Yuri Rafael', 'Initials': 'YR', 'LastName': 'Dos Santos Franco', 'Affiliation': ''}, {'ForeName': 'Naiane Teixeira', 'Initials': 'NT', 'LastName': 'Bastos De Oliveira', 'Affiliation': ''}, {'ForeName': 'Mark Jonathan', 'Initials': 'MJ', 'LastName': 'Hancock', 'Affiliation': ''}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'Van Tulder', 'Affiliation': ''}, {'ForeName': 'Cristina Maria', 'Initials': 'CM', 'LastName': 'Nunes Cabral', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2019.8839']
393,31663814,Task-Specific Sensitivity in Physical Function Testing Predicts Outcome in Patients With Low Back Pain.,"OBJECTIVE


To investigate the prognostic value of task-specific sensitivity in patients with low back pain by exploring whether task-specific sensitivity during physical function testing was associated with self-reported change in pain and disability.
DESIGN


Prospective cohort study nested in a randomized controlled trial.
METHODS


The study included 260 patients with low back pain, referred for evaluation in a secondary care setting. All patients completed questionnaires and underwent clinical examination by a physical therapist. Patients rated their pain intensity before and after completing a test battery measuring physical function and were classified into 4 categories-worse, unchanged, better, or no pain-depending on their pain response. At 3-month follow-up, outcomes were obtained by a postal questionnaire.
RESULTS


Task-specific sensitivity significantly predicted pain, after adjusting for known prognostic factors. Patients in the no pain, better, and unchanged groups improved their pain score significantly more than patients in the worse pain group. Patients in the no pain group also improved their disability score significantly more compared to patients in the worse pain group, after adjusting for known prognostic factors.
CONCLUSION


Task-specific sensitivity predicted pain intensity after 3 months in patients with low back pain. The prognostic value appears limited with respect to disability. J Orthop Sports Phys Ther 2020;50(4):206-213. Epub 30 Oct 2019. doi:10.2519/jospt.2020.8953.",2020,"Patients classified as  no pain  also improved significantly more in disability score compared to patients classified as  worse  after adjusting for known prognostic factors.
","['260 patients with LBP, referred for evaluation in secondary care setting', 'Low back pain (LBP', 'patients with LBP', 'Patients With Low Back Pain']",[],"['pain score', 'pain intensity', 'disability score']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}]",[],"[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",260.0,0.0711021,"Patients classified as  no pain  also improved significantly more in disability score compared to patients classified as  worse  after adjusting for known prognostic factors.
","[{'ForeName': 'Nûno', 'Initials': 'N', 'LastName': 'Trolle', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Maribo', 'Affiliation': ''}, {'ForeName': 'Lone Donbæk', 'Initials': 'LD', 'LastName': 'Jensen', 'Affiliation': ''}, {'ForeName': 'David Høyrup', 'Initials': 'DH', 'LastName': 'Christiansen', 'Affiliation': ''}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2020.8953']
394,31686199,"A prospective, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of SNZ TriBac, a three-strain Bacillus probiotic blend for undiagnosed gastrointestinal discomfort.","PURPOSE


This prospective, randomized, double-blind, placebo-controlled, parallel-group study aimed to determine the efficacy and safety of a multistrain (Bacillus coagulans [SNZ 1969], Bacillus clausii [SNZ 1971], and Bacillus subtilis [SNZ 1972]) probiotic blend (SNZ TriBac) in managing symptoms of gastrointestinal (GI) discomfort in the absence of specific pathologies.
METHODS


Sixty adults with symptoms of GI discomfort were enrolled (mean age, 34.89 ± 9.95 years) and randomized to receive either SNZ TriBac or placebo. Changes from baseline in Severity of Dyspepsia Assessment (SODA), Gastrointestinal Symptom Rating Scale (GSRS), and Quality of Life (QoL) scales over the course of product use were determined at baseline and on days 30 and 37 as study outcomes.
RESULTS


On day 30, significant improvement with SNZ TriBac was noted in SODA burping/belching (P = 0.025), bloating (P = 0.048), sour taste (P = 0.025), and total (P = 0.007) scores as well as pain (P = 0.003), non-pain (P = 0.04), and satisfaction (P = 0.03) subscores. Significant improvement with SNZ TriBac was also observed in SODA burping/belching (P = 0.011), sour taste (P = 0.011), and total SODA scores (P < 0.001), and in SODA pain (P = 0.005), non-pain (P = 0.06), and satisfaction (P = 0.004) subscores on day 37. No adverse events were reported.
CONCLUSION


Significant improvement in final SODA scores and subscores with SNZ TriBac versus placebo indicates improvement in several symptoms of gastrointestinal discomfort. This multistrain probiotic blend was well tolerated and could be an effective option for treatment of GI discomfort.
TRIAL REGISTRATION


Clinical Trials Registry of India (CTRI/2018/05/014071).",2019,"Changes from baseline in Severity of Dyspepsia Assessment (SODA), Gastrointestinal Symptom Rating Scale (GSRS), and Quality of Life (QoL) scales over the course of product use were determined at baseline and on days 30 and 37 as study outcomes.
","['undiagnosed gastrointestinal discomfort', 'Sixty adults with symptoms of GI discomfort were enrolled (mean age, 34.89 ± 9.95 years']","['placebo', 'SNZ TriBac or placebo', 'SNZ TriBac', 'multistrain (Bacillus coagulans [SNZ 1969], Bacillus clausii [SNZ 1971], and Bacillus subtilis [SNZ 1972]) probiotic blend (SNZ TriBac']","['adverse events', 'total SODA scores', 'efficacy and safety', 'sour taste', 'pain', 'bloating', 'Severity of Dyspepsia Assessment (SODA), Gastrointestinal Symptom Rating Scale (GSRS), and Quality of Life (QoL) scales', 'SNZ TriBac', 'SODA burping/belching', 'final SODA scores', 'several symptoms of gastrointestinal discomfort', 'non-pain', 'SODA pain', 'satisfaction']","[{'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0314879', 'cui_str': 'Lactobacillus sporogenes'}, {'cui': 'C1034048', 'cui_str': 'Bacillus clausii'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0222045'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0014724', 'cui_str': 'Belching'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1096250', 'cui_str': 'Gastrointestinal discomfort'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",60.0,0.425542,"Changes from baseline in Severity of Dyspepsia Assessment (SODA), Gastrointestinal Symptom Rating Scale (GSRS), and Quality of Life (QoL) scales over the course of product use were determined at baseline and on days 30 and 37 as study outcomes.
","[{'ForeName': 'Raunak Jay', 'Initials': 'RJ', 'LastName': 'Soman', 'Affiliation': 'Sanzyme Biologics Pvt. Ltd., Plot no. 13, Sagar Society, Road No. 2, Banjara Hills, Hyderabad, 500034, India. Info@sanzymebiologics.com.'}, {'ForeName': 'Malisetty Venkat', 'Initials': 'MV', 'LastName': 'Swamy', 'Affiliation': 'Sanzyme Biologics Pvt. Ltd., Plot no. 13, Sagar Society, Road No. 2, Banjara Hills, Hyderabad, 500034, India.'}]",International journal of colorectal disease,['10.1007/s00384-019-03416-w']
395,32239305,The novel mechanism of valproate to prevent peritoneal adhesion formation.,"PURPOSE


A novel pharmacological mechanism of valproate was analyzed using a hamster model of adhesion.
METHODS


Valproate or placebo was administered just after cecal injury and adhesion severity scores and histological were analyzed.
RESULTS


The adhesion severity scores in the placebo- and valproate-treated groups were 2.67 ± 0.42 and 1.0 ± 0.37, respectively, with a significant difference between the groups. A significant increase in mast cell numbers was observed in the placebo-treated group vs. the sham-operated group; however, the mast cell number in the adhesive lesion was significantly lower in the valproate-treated group than in the placebo-treated group. The number of cells positive for chymase, an enzyme in mast cells, in the adhesive lesion was significantly higher in the placebo-treated group, but its increase was attenuated significantly by treatment with valproate. The myeloperoxidase gene expression level in the cecum was significantly higher in the placebo-treated group than in the sham-operated group, but there was no significant difference in the myeloperoxidase gene expression level between the sham-operated and valproate-treated groups in. In an in vitro experiment, valproate inhibited purified human and hamster chymases dose-dependently.
CONCLUSION


The chymase inhibitory effect of valproate may contribute to prevent adhesion formation after abdominal injury.",2020,"The number of cells positive for chymase, an enzyme in mast cells, in the adhesive lesion was significantly higher in the placebo-treated group, but its increase was attenuated significantly by treatment with valproate.",[],"['placebo', 'valproate', 'Valproate or placebo']","['mast cell numbers', 'number of cells positive for chymase, an enzyme in mast cells', 'mast cell number in the adhesive lesion', 'adhesion severity scores', 'myeloperoxidase gene expression level', 'adhesive lesion']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0080356', 'cui_str': 'Valproate'}]","[{'cui': 'C0024880', 'cui_str': 'Mast cell'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0055673', 'cui_str': 'Chymase'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.194655,"The number of cells positive for chymase, an enzyme in mast cells, in the adhesive lesion was significantly higher in the placebo-treated group, but its increase was attenuated significantly by treatment with valproate.","[{'ForeName': 'Shuangping', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Chronic Disease Research Center, Medical College, Dalian University, Dalian, 116622, Liaoning, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Chronic Disease Research Center, Medical College, Dalian University, Dalian, 116622, Liaoning, China.'}, {'ForeName': 'Denan', 'Initials': 'D', 'LastName': 'Jin', 'Affiliation': 'Department of Innovative Medicine, Osaka Medical College, Takatsuki, 569-8686, Japan.'}, {'ForeName': 'Qinggao', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Chronic Disease Research Center, Medical College, Dalian University, Dalian, 116622, Liaoning, China. zqg0621@ybu.edu.cn.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Takai', 'Affiliation': 'Department of Innovative Medicine, Osaka Medical College, Takatsuki, 569-8686, Japan. pha010@osaka-med.ac.jp.'}]",Surgery today,['10.1007/s00595-020-01979-8']
396,32234755,"A Randomized, Open-label, Presurgical, Window-of-Opportunity Study Comparing the Pharmacodynamic Effects of the Novel Oral SERD AZD9496 with Fulvestrant in Patients with Newly Diagnosed ER +  HER2 -  Primary Breast Cancer.","PURPOSE


Fulvestrant, the first-in-class selective estrogen receptor (ER) degrader (SERD), is clinically effective in patients with ER +  breast cancer, but it has administration and pharmacokinetic limitations. Pharmacodynamic data suggest complete ER degradation is not achieved at fulvestrant's clinically feasible dose. This presurgical study (NCT03236974) compared the pharmacodynamic effects of fulvestrant with AZD9496, a novel, orally bioavailable, nonsteroidal, potent SERD, in treatment-naïve patients with ER +  HER2 -  primary breast cancer awaiting curative intent surgery.
PATIENTS AND METHODS


Patients were randomized 1:1 to receive AZD9496 250 mg twice daily from day 1 for 5-14 days, or fulvestrant 500 mg on day 1. On-treatment imaging-guided core tumor biopsies were taken between day 5 and 14 and compared with pretreatment diagnostic biopsies. The primary objective was to compare the effects of AZD9496 and fulvestrant on ER expression. Secondary objectives included changes in progesterone receptor (PR) and Ki-67 pharmacokinetic/pharmacodynamic relationships and safety.
RESULTS


Forty-six women received treatment (AZD9496  n  = 22; fulvestrant  n  = 24); 35 paired biopsies were evaluable (AZD9496  n  = 15; fulvestrant  n  = 20). The least square mean estimate for ER H-score reduction was 24% after AZD9496 versus 36% after fulvestrant treatment ( P  = 0.86). AZD9496 also reduced PR H-scores (-33.3%) and Ki-67 levels (-39.9%) from baseline, but was also not superior to fulvestrant (PR: -68.7%,  P  = 0.97; Ki-67: -75.4%,  P  = 0.98). No new safety findings were identified.
CONCLUSIONS


This was the first presurgical study to demonstrate that an oral SERD affects its key biological targets. However, AZD9496 was not superior to fulvestrant at the dose tested.",2020,"AZD9496 also reduced PR H-scores (-33.3%) and Ki‑67 levels (-39.9%) from baseline, but was also not superior to fulvestrant (PR: -68.7%, p=0.97; Ki‑67: ‑75.4%, p=0.98).","['Forty-six women received treatment (AZD9496 n=22; fulvestrant n=24); 35 paired biopsies were evaluable (AZD9496 n=15; fulvestrant n=20', 'patients with ER+ HER2- primary breast cancer', 'Patients', 'treatment‑naive patients with ER+ human epidermal growth factor receptor 2 negative primary breast cancer awaiting curative intent surgery', 'patients with ER+ breast cancer']","['fulvestrant with AZD9496', 'novel oral SERD AZD9496 with fulvestrant', 'AZD9496 250 mg twice daily from Day (D) 1 for 5-14 days, or fulvestrant 500 mg on D 1', 'AZD9496 and fulvestrant']","['PR H-scores', 'changes in progesterone receptor (PR) and Ki-67 PK/PD relationships and safety', 'Ki‑67 levels', 'ER expression', 'least square mean estimate for ER H-score reduction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4053676', 'cui_str': 'AZD9496'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0279754', 'cui_str': 'ESR1 positive'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C2938924', 'cui_str': 'Oestrogen receptor positive breast cancer'}]","[{'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C4053676', 'cui_str': 'AZD9496'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034833', 'cui_str': 'Progesterone receptor'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0472463,"AZD9496 also reduced PR H-scores (-33.3%) and Ki‑67 levels (-39.9%) from baseline, but was also not superior to fulvestrant (PR: -68.7%, p=0.97; Ki‑67: ‑75.4%, p=0.98).","[{'ForeName': 'John F R', 'Initials': 'JFR', 'LastName': 'Robertson', 'Affiliation': 'University of Nottingham, Nottingham, United Kingdom. john.robertson@nottingham.ac.uk.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Evans', 'Affiliation': 'Poole Hospital, Poole, United Kingdom.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Henschen', 'Affiliation': 'Helios Clinics Schwerin, Schwerin, Germany.'}, {'ForeName': 'Cliona C', 'Initials': 'CC', 'LastName': 'Kirwan', 'Affiliation': 'University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jahan', 'Affiliation': ""King's Mill Hospital, Mansfield, United Kingdom.""}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Kenny', 'Affiliation': 'Imperial College London and Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Dixon', 'Affiliation': 'Western General Hospital, Edinburgh, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Kothari', 'Affiliation': ""Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Mohamed', 'Affiliation': 'Johannes Wesling General Hospital, Minden, Germany.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Department of Gynecology and Obstetrics, Comprehensive Cancer Center Erlangen-EMN, Erlangen University Hospital, Friedrich Alexander University of Erlangen-Nuremberg, Nuremberg, Germany.'}, {'ForeName': 'Kwok-Leung', 'Initials': 'KL', 'LastName': 'Cheung', 'Affiliation': 'University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Wuerstlein', 'Affiliation': 'Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center, University of Munich (LMU), Munich, Germany.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Carroll', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Klinowska', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Justin P O', 'Initials': 'JPO', 'LastName': 'Lindemann', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'MacDonald', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Mather', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Maudsley', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Moschetta', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Myria', 'Initials': 'M', 'LastName': 'Nikolaou', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Martine P', 'Initials': 'MP', 'LastName': 'Roudier', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Tinnu', 'Initials': 'T', 'LastName': 'Sarvotham', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Schiavon', 'Affiliation': 'Research and Early Development, Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Diansong', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Clinical Pharmacology and Safety Sciences, BioPharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center, University of Munich (LMU), Munich, Germany.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3387']
397,32233922,"Speech-Language Pathologists' Comfort Level With Use of Term ""Stuttering"" During Evaluations.","Purpose Speech-language pathologists (SLPs) anecdotally report concern that their interactions with a child who stutters, including even the use of the term ""stuttering,"" might contribute to negative affective, behavioral, and cognitive consequences. This study investigated SLPs' comfort in providing a diagnosis of ""stuttering"" to children's parents/caregivers, as compared to other commonly diagnosed developmental communication disorders. Method One hundred forty-one school-based SLPs participated in this study. Participants were randomly assigned to one of two vignettes detailing an evaluation feedback session. Then, participants rated their level of comfort disclosing diagnostic terms to parents/caregivers. Participants provided rationale for their ratings and answered various questions regarding academic and clinical experiences to identify factors that may have influenced ratings. Results SLPs were significantly less likely to feel comfortable using the term ""stuttering"" compared to other communication disorders. Thematic responses revealed increased experience with a specific speech-language population was related to higher comfort levels with using its diagnostic term. Additionally, knowing a person who stutters predicted greater comfort levels as compared to other clinical and academic experiences. Conclusions SLPs were significantly less comfortable relaying the diagnosis ""stuttering"" to families compared to other speech-language diagnoses. Given the potential deleterious effects of avoidance of this term for both parents and children who stutter, future research should explore whether increased exposure to persons who stutter of all ages systematically improves comfort level with the use of this term.",2020,"Conclusions SLPs were significantly less comfortable relaying the diagnosis ""stuttering"" to families compared to other speech-language diagnoses.",['Method One hundred forty-one school-based SLPs participated in this study'],['evaluation feedback session'],"[""Speech-Language Pathologists' Comfort Level"", 'comfort levels']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0334866', 'cui_str': 'Medical pathologist'}, {'cui': 'C0517225', 'cui_str': 'Comfort level'}]",141.0,0.0196745,"Conclusions SLPs were significantly less comfortable relaying the diagnosis ""stuttering"" to families compared to other speech-language diagnoses.","[{'ForeName': 'Courtney T', 'Initials': 'CT', 'LastName': 'Byrd', 'Affiliation': 'Department of Communication Sciences and Disorders, The University of Texas at Austin.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Werle', 'Affiliation': 'Department of Communication Sciences and Disorders, The University of Texas at Austin.'}, {'ForeName': 'Kenneth O', 'Initials': 'KO', 'LastName': 'St Louis', 'Affiliation': 'Department of Communication Sciences and Disorders, West Virginia University, Morgantown.'}]",American journal of speech-language pathology,['10.1044/2020_AJSLP-19-00081']
398,29941057,Switching stable patients with schizophrenia from their oral antipsychotics to aripiprazole lauroxil: a post hoc safety analysis of the initial 12-week crossover period.,"OBJECTIVE


Switching antipsychotic medications is common in patients with schizophrenia who are experiencing persistent symptoms or tolerability issues associated with their current drug regimen. This analysis assessed the safety of switching from an oral antipsychotic to the long-acting injectable antipsychotic aripiprazole lauroxil (AL).
METHODS


This was a post hoc analysis of outpatients with schizophrenia who were prescribed an oral antipsychotic and who enrolled in an international, open-label, long-term (52-week) safety study of AL. The analysis focused on the first 3 injections of AL 882 mg over 12 weeks, divided into the immediate 4-week crossover period between the first and second AL injections (initiation phase) and the subsequent 8 weeks (stabilization phase). Patients were grouped by preswitch oral antipsychotic medication, and safety and clinical symptoms were assessed.
RESULTS


In total, 190 patients had switched from one of the following oral antipsychotic medications: aripiprazole, conventional antipsychotics, risperidone/paliperidone, olanzapine, or quetiapine. The 12-week completion rate was high (92.1%) and similar across the different preswitch oral antipsychotic groups. Overall, adverse event (AE) rates experienced over 12 weeks were modest; no AEs were considered serious. The most common AEs in the initiation phase were injection site pain (5.8%), insomnia (5.8%), and akathisia (3.2%). No apparent relationship was observed between preswitch medication and early-onset AEs. Mean Positive and Negative Syndrome Scale total scores remained stable during this period across preswitch antipsychotic groups.
CONCLUSION


Switching from an oral antipsychotic to AL was feasible in an outpatient setting for patients with schizophrenia, and the 12-week retention rate was favorable.",2019,"Mean Positive and Negative Syndrome Scale total scores remained stable during this period across preswitch antipsychotic groups.
","['outpatients with schizophrenia who were prescribed an oral antipsychotic and who enrolled in an international, open-label, long-term (52-week) safety study of AL', '190 patients had switched from one of the following oral antipsychotic medications', 'patients with schizophrenia']","['aripiprazole lauroxil', 'aripiprazole, conventional antipsychotics, risperidone/paliperidone, olanzapine, or quetiapine']","['12-week completion rate', 'Overall, adverse event (AE) rates', 'insomnia', 'akathisia', 'Mean Positive and Negative Syndrome Scale total scores', 'injection site pain']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C4056439', 'cui_str': 'aripiprazole lauroxil'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0753678', 'cui_str': 'paliperidone'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}]",190.0,0.0234675,"Mean Positive and Negative Syndrome Scale total scores remained stable during this period across preswitch antipsychotic groups.
","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Weiden', 'Affiliation': 'Medical Affairs,Alkermes, Inc.,Waltham,Massachusetts,USA.'}, {'ForeName': 'Yangchun', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Clinical Development,Alkermes, Inc.,Waltham,Massachusetts,USA.'}, {'ForeName': 'Chih-Chin', 'Initials': 'CC', 'LastName': 'Liu', 'Affiliation': 'Clinical Development,Alkermes, Inc.,Waltham,Massachusetts,USA.'}, {'ForeName': 'Arielle D', 'Initials': 'AD', 'LastName': 'Stanford', 'Affiliation': 'Clinical Science,Alkermes, Inc.,Waltham,Massachusetts,USA.'}]",CNS spectrums,['10.1017/S1092852918000986']
399,32229771,Protein Supplementation and Resistance Training in Childhood Cancer Survivors.,"PURPOSE


Muscle weakness, low lean body mass, and poor physical performance are prevalent among adult survivors of childhood cancer (survivors). We evaluated the feasibility and effects of resistance training with and without protein supplementation on lean body mass and muscle strength among survivors.
METHODS


This double-blind placebo-controlled trial enrolled survivors aged ≥18 to <45 years. Participants were randomized to resistance training with protein supplement (21g whey protein/day, 90kcal) (RT+S) or resistance training with placebo (sucrose, 90kcal) (RT+P). Participants received educational materials, access to a local fitness center, and a tailored resistance training program with tapered supervision. Participant retention and adherence were used to evaluate feasibility. Lean body mass and muscle strength were assessed at baseline and 24-weeks, using dual x-ray absorptiometry, and dynamometer testing or 1-repetition maximum testing, respectively. Mean changes were compared with two-way analysis of variance.
RESULTS


Of 70 participants randomized, 57 completed the 24-week intervention (24 in RT+S, 33 in RT+P). RT+S group completed 74.8% and RT+P group completed 67.0% of exercise sessions. Mean age for those who completed was 33.1 years (SD 7.0), 67% were white and 47% female. There were no differences in change in lean mass (RT+S mean 1.05 kg [SD 2.34], RT+P 0.13 kg [SD 2.19], p=0.10) or strength (RT+S mean grip 1.65 kg [SD 4.17], RT+P 1.63 kg [SD 4.47], p=0.98; mean leg press RT+S 58.4 kg [SD 78.8], RT+P 51.0 kg [SD 65.1], p=0.68) between groups. Both lean mass (p=0.03) and strength (grip p=0.003, leg press p<0.001) increased over time.
CONCLUSIONS


Supervised resistance training among survivors with protein supplementation is feasible but not more effective at increasing total lean body mass than resistance training alone.",2020,"Both lean mass (p=0.03) and strength (grip p=0.003, leg press p<0.001) increased over time.
","['Childhood Cancer Survivors', 'adult survivors of childhood cancer (survivors', 'Mean age for those who completed was 33.1 years (SD 7.0), 67% were white and 47% female', 'controlled trial enrolled survivors aged ≥18 to <45 years', 'Of 70 participants randomized, 57 completed the 24-week intervention (24 in RT+S, 33 in RT+P', 'survivors']","['RT+S', 'placebo', 'Supervised resistance training', 'resistance training with protein supplement (21g whey protein/day, 90kcal) (RT+S) or resistance training with placebo (sucrose, 90kcal) (RT+P', 'Protein Supplementation and Resistance Training', 'RT+P', 'educational materials, access to a local fitness center, and a tailored resistance training program with tapered supervision', 'resistance training with and without protein supplementation']","['lean mass', 'strength (grip p=0.003, leg press p<0.001) increased over time', 'Lean body mass and muscle strength', 'lean body mass and muscle strength']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C1959943', 'cui_str': '21G (qualifier value)'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0600623', 'cui_str': 'Fitness Centers'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",70.0,0.159499,"Both lean mass (p=0.03) and strength (grip p=0.003, leg press p<0.001) increased over time.
","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Krull', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Carrie R', 'Initials': 'CR', 'LastName': 'Howell', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Robyn E', 'Initials': 'RE', 'LastName': 'Partin', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lanctot', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Phipps', 'Affiliation': ""Department of Psychology, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Klosky', 'Affiliation': ""Department of Pediatrics, Emory University School of Medicine, and the Aflac Cancer and Blood Disorders Center, Children's Healthcare of Atlanta, Atlanta, GA.""}, {'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Carney', 'Affiliation': ""Department of Clinical Nutrition, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Mulrooney', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Leslie L', 'Initials': 'LL', 'LastName': 'Robison', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Hudson', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Kirsten K', 'Initials': 'KK', 'LastName': 'Ness', 'Affiliation': ""Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN.""}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002345']
400,31945300,Early Bactericidal Activity of Different Isoniazid Doses for Drug Resistant TB (INHindsight): A Randomized Open-label Clinical Trial.,"RATIONALE


High-dose isoniazid is recommended in short-course regimens for multidrug-resistant TB (MDR-TB). The optimal dose of isoniazid and its individual contribution to efficacy against TB strains with inhA or katG mutations are unknown.
OBJECTIVE


Define the optimal dose of isoniazid for patients with isoniazid-resistant TB mediated by inhA mutations.
METHODS


AIDS Clinical Trials Group A5312 is a Phase 2A, open-label trial in which individuals with smear-positive pulmonary TB with isoniazid resistance mediated by an inhA mutation were randomized to receive isoniazid 5, 10 or 15 mg/kg daily for 7 days (inhA group), and controls with drug-sensitive TB received standard dose (5 mg/kg/day). Overnight sputum cultures were collected daily. The 7-day early bactericidal activity of isoniazid was estimated as the average daily change in log10 colony forming units on solid media (EBACFU0-7) or as time to positivity in liquid media in hours (EBATTP0-7) using nonlinear mixed effects models.
MEASUREMENTS AND MAIN RESULTS


Fifty-nine participants, 88% with cavitary disease, 20% HIV-positive, 16 with isoniazid-sensitive and 41 with isoniazid mono-resistant or MDR TB, were enrolled at one site in South Africa. Mean EBACFU0-7 at doses of 5, 10 and 15 mg/kg in the inhA group was 0.07, 0.17 and 0.22 log10CFU/mL/day, respectively, and 0.16 log10CFU/mL/day in controls. EBATTP0-7 patterns were similar. There were no drug-related Grade >3 adverse events.
CONCLUSIONS


Isoniazid 10-15 mg/kg daily had similar activity against TB strains with inhA mutations as 5 mg/kg against drug-sensitive strains. The activity of high-dose isoniazid against strains with katG mutations will be explored next. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT01936831.",2020,"There were no drug-related Grade >3 adverse events.
","['Fifty-nine participants, 88% with cavitary disease, 20% HIV-positive, 16 with isoniazid-sensitive and 41 with isoniazid mono-resistant or MDR TB, were enrolled at one site in South Africa', 'individuals with smear-positive pulmonary TB with isoniazid resistance mediated by an inhA mutation', 'Drug Resistant TB (INHindsight', 'patients with isoniazid-resistant TB mediated by inhA mutations']","['Isoniazid', 'isoniazid']",[],"[{'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}]",[],59.0,0.319838,"There were no drug-related Grade >3 adverse events.
","[{'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Johns Hopkins University, Medicine, Baltimore, Maryland, United States; kdooley1@jhmi.edu.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Miyahara', 'Affiliation': 'Harvard University T H Chan School of Public Health, 1857, Boston, Massachusetts, United States.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'von Groote-Bidlingmaier', 'Affiliation': 'Stellenbosch University Faculty of Medicine and Health Sciences, 121470, TASK Applied Science, Cape Town, South Africa.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Harvard University T H Chan School of Public Health, 1857, Boston, Massachusetts, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hafner', 'Affiliation': 'National Institutes of Health, Division of AIDS, Bethesda, Maryland, United States.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Rosenkranz', 'Affiliation': 'Harvard University T H Chan School of Public Health, 1857, Boston, Massachusetts, United States.'}, {'ForeName': 'Elisa H', 'Initials': 'EH', 'LastName': 'Ignatius', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, United States.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Nuermberger', 'Affiliation': 'Johns Hopkins University, Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Moran', 'Affiliation': 'Social & Scientific Systems Inc, 43740, Silver Spring, Maryland, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Donahue', 'Affiliation': 'Frontier Science and Technology Research Foundation, 2402, Boston, Massachusetts, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Swindells', 'Affiliation': 'Nebraska Medicine, 21039, Omaha, Nebraska, United States.'}, {'ForeName': 'Naadira', 'Initials': 'N', 'LastName': 'Vanker', 'Affiliation': 'TASK Applied Science, Cape Town, South Africa.'}, {'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Diacon', 'Affiliation': 'University of Stellenbosch, Internal Medicine, Tygerberg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201910-1960OC']
401,31778291,Stratified exercise therapy compared with usual care by physical therapists in patients with knee osteoarthritis: A randomized controlled trial protocol (OCTOPuS study).,"OBJECTIVES


Knee osteoarthritis (OA) is characterized by its heterogeneity, with large differences in clinical characteristics between patients. Therefore, a stratified approach to exercise therapy, whereby patients are allocated to homogeneous subgroups and receive a stratified, subgroup-specific intervention, can be expected to optimize current clinical effects. Recently, we developed and pilot tested a model of stratified exercise therapy based on clinically relevant subgroups of knee OA patients that we previously identified. Based on the promising results, it is timely to evaluate the (cost-)effectiveness of stratified exercise therapy compared with usual, ""nonstratified"" exercise therapy.
METHODS


A pragmatic cluster randomized controlled trial including economic and process evaluation, comparing stratified exercise therapy with usual care by physical therapists (PTs) in primary care, in a total of 408 patients with clinically diagnosed knee OA. Eligible physical therapy practices are randomized in a 1:2 ratio to provide the experimental (in 204 patients) or control intervention (in 204 patients), respectively. The experimental intervention is a model of stratified exercise therapy consisting of (a) a stratification algorithm that allocates patients to a ""high muscle strength subgroup,"" ""low muscle strength subgroup,"" or ""obesity subgroup"" and (b) subgroup-specific, protocolized exercise therapy (with an additional dietary intervention from a dietician for the obesity subgroup only). The control intervention will be usual best practice by PTs (i.e., nonstratified exercise therapy). Our primary outcome measures are knee pain severity (Numeric Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score subscale daily living). Measurements will be performed at baseline, 3-month (primary endpoint), 6-month (questionnaires only), and 12-month follow-up, with an additional cost questionnaire at 9 months. Intention-to-treat, multilevel, regression analysis comparing stratified versus usual care will be performed.
CONCLUSION


This study will demonstrate whether stratified care provided by primary care PTs is effective and cost-effective compared with usual best practice from PTs.",2020,This study will demonstrate whether stratified care provided by primary care PTs is effective and cost-effective compared with usual best practice from PTs.,"['408 patients with clinically diagnosed knee OA', 'patients with knee osteoarthritis', 'Knee osteoarthritis (OA']","['Stratified exercise therapy', 'control intervention', 'stratified exercise therapy consisting of (a) a stratification algorithm that allocates patients to a ""high muscle strength subgroup,"" ""low muscle strength subgroup,"" or ""obesity subgroup"" and (b) subgroup-specific, protocolized exercise therapy (with an additional dietary intervention', 'stratified exercise therapy', 'stratified exercise therapy with usual care by physical therapists (PTs', 'usual care by physical therapists']",['knee pain severity (Numeric Rating Scale) and physical functioning (Knee Injury and Osteoarthritis Outcome Score subscale daily living'],"[{'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}]","[{'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0002045'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",408.0,0.114051,This study will demonstrate whether stratified care provided by primary care PTs is effective and cost-effective compared with usual best practice from PTs.,"[{'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Knoop', 'Affiliation': 'Department of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Dekker', 'Affiliation': 'VU University Medical Center, Department of Rehabilitation Medicine, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Marike', 'Initials': 'M', 'LastName': 'van der Leeden', 'Affiliation': 'VU University Medical Center, Department of Rehabilitation Medicine, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Mariëtte', 'Initials': 'M', 'LastName': 'de Rooij', 'Affiliation': 'Amsterdam Rehabilitation Research Centre, Reade, Amsterdam, The Netherlands.'}, {'ForeName': 'Wilfred F H', 'Initials': 'WFH', 'LastName': 'Peter', 'Affiliation': 'Amsterdam Rehabilitation Research Centre, Reade, Amsterdam, The Netherlands.'}, {'ForeName': 'Leti', 'Initials': 'L', 'LastName': 'van Bodegom-Vos', 'Affiliation': 'Department of Orthopaedics, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Johanna M', 'Initials': 'JM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Nique', 'Initials': 'N', 'LastName': 'Lopuhäa', 'Affiliation': 'ReumaNederland, Amsterdam, The Netherlands.'}, {'ForeName': 'Kim L', 'Initials': 'KL', 'LastName': 'Bennell', 'Affiliation': 'School of Health Sciences, Department of Physiotherapy, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Willem F', 'Initials': 'WF', 'LastName': 'Lems', 'Affiliation': 'VU University Medical Center, Department of Rehabilitation Medicine, Amsterdam UMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'van der Esch', 'Affiliation': 'Amsterdam Rehabilitation Research Centre, Reade, Amsterdam, The Netherlands.'}, {'ForeName': 'Thea P M', 'Initials': 'TPM', 'LastName': 'Vliet Vlieland', 'Affiliation': 'Department of Orthopaedics, Leiden University Medical Center (LUMC), Leiden, The Netherlands.'}, {'ForeName': 'Raymond W J G', 'Initials': 'RWJG', 'LastName': 'Ostelo', 'Affiliation': 'Department of Health Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1819']
402,31741073,Single Dose Steroid Injection After Loss of Signal (LOS) During Thyroid Surgery is Effective to Recover Electric Signal Avoiding Vocal Cord Palsy and the Need of Staged Thyroidectomy: Prospective Evaluation on 702 Patients.,"BACKGROUND


Steroids are often used for the management of vocal cord palsy after thyroid surgery. There are no reports in the current literature of their intraoperative use, immediately after a loss of signal during neuromonitoring (LOS). We evaluate the impact of a single dose of 4 mg of dexamethasone on laryngeal nerve function, administrated at the time of a LOS during a nerve-monitored thyroidectomy.
METHODS


A prospective not randomized study was performed, dividing patients in two groups, when a LOS was detected. LOS was defined as an electromyographic signal (EMG) inferior to 100 μV when stimulating the inferior laryngeal nerve, according to international guidelines. In group 1 (G1), surgeon waits for signal's recovery up to 20 min. Absence of a detectable signal after 20 min was predictive of vocal cord palsy; if it affected the first side of surgery the procedure was interrupted to avoid the risk of bilateral nerve palsy. In group 2 (G2), 4 mg of dexamethasone were injected within 10 min from a detected LOS, waiting 10 min for its effects. An EMG value > to 200 μV within 20' after steroid administration was predictive of full recovery and normal post-operatory vocal cord function. Vocal cords motility was checked at postoperative day 1 in all patients by an experienced ENT.
RESULTS


Between January 2017 and December 2018, 702 patients underwent thyroid surgery under intermittent intraoperative nerve monitoring by two expert surgeons. A LOS was found in 22 patients in G1 and 16 in G2. Four patients in G1 spontaneously recovered electric signal (18.2%), while in G2 a signal was recovered in 14/16 patients (87.5%) (p < 0.001). This immediate effect was monitored by EMG, showing the increase in potentials at 10, 15 and 20 min after injection. ENT evaluation found vocal cord palsy, respectively, in 18/22 and 1/16 patients (G1 vs G2, p < 0.001). One of the patients in G2 who recovered electric signal presented transient palsy, fully recovered at 2 months, while the two patients who had a signal < 200 μV did not present postoperative cord palsy. In G1, 10/18 palsy were definitive. No permanent palsies were presents in G2.
CONCLUSION


A single 4 mg iv dexamethasone injection within 10 min form a LOS during thyroid surgery exerts a therapeutic action, measurable by EMG modifications. It avoids vocal nerve palsy and the need of a staged thyroidectomy. It may also protect from permanent cord palsy, but the mechanism is unknown.",2020,Absence of a detectable signal after 20 min was predictive of vocal cord palsy; if it affected the first side of surgery the procedure was interrupted to avoid the risk of bilateral nerve palsy.,"['Between January 2017 and December 2018, 702 patients underwent thyroid surgery under intermittent intraoperative nerve monitoring by two expert surgeons', '702 Patients', 'vocal cord palsy after thyroid surgery', '22 patients in G1 and 16 in G2']","['Steroid Injection', 'Staged Thyroidectomy', 'dexamethasone', 'Signal (LOS']","['LOS', 'Vocal cords motility', 'electric signal', 'vocal cord palsy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0042928', 'cui_str': 'Total Vocal Cord Paralysis'}]","[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0042930', 'cui_str': 'Vocal Fold'}, {'cui': 'C1510470', 'cui_str': 'Motility (observable entity)'}, {'cui': 'C0042928', 'cui_str': 'Total Vocal Cord Paralysis'}]",702.0,0.0914179,Absence of a detectable signal after 20 min was predictive of vocal cord palsy; if it affected the first side of surgery the procedure was interrupted to avoid the risk of bilateral nerve palsy.,"[{'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Donatini', 'Affiliation': 'General and Endocrine Surgery, CHU Poitiers, University of Poitiers, 2 Rue de la Miletrie, 86021, Poitiers, France. Giacko76@hotmail.com.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Danion', 'Affiliation': 'General and Endocrine Surgery, CHU Poitiers, University of Poitiers, 2 Rue de la Miletrie, 86021, Poitiers, France.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Zerrweck', 'Affiliation': 'ABC Hospital, Mexico City, Mexico.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Etienne', 'Affiliation': 'General and Endocrine Surgery, CHU Poitiers, University of Poitiers, 2 Rue de la Miletrie, 86021, Poitiers, France.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Lacoste', 'Affiliation': 'Department of Anesthesia CHU Poitiers, University of Poitiers, Poitiers, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Kraimps', 'Affiliation': 'General and Endocrine Surgery, CHU Poitiers, University of Poitiers, 2 Rue de la Miletrie, 86021, Poitiers, France.'}]",World journal of surgery,['10.1007/s00268-019-05295-2']
403,31728054,Randomized assessment of delayed intensification and two methods for parenteral methotrexate delivery in childhood B-ALL: Children's Oncology Group Studies P9904 and P9905.,"The delayed intensification (DI) enhanced outcome for patients with acute lymphoblastic leukemia (ALL) treated on BFM 76/79 and CCG 105 after a prednisone-based induction. Childrens Oncology Group protocols P9904/9905 evaluated DI via a post-induction randomization for eligible National Cancer Institute (NCI) standard (SR) and high-risk (HR) patients. A second randomization compared intravenous methotrexate (IV MTX) as a 24- (1 g/m 2 ) vs. 4-h (2 g/m 2 ) infusion. NCI SR patients received a dexamethasone-based three-drug and NCI HR/CNS 3 SR patients a prednisone-based four-drug induction. End induction MRD (minimal residual disease) was obtained but did not impact treatment. DI improved the 10-year continuous complete remission (CCR) rate; 75.5 ± 2.5% vs. 81.8 ± 2.2% p = 0.002, whereas MTX administration did not; 4-h 80.8 ± 1.9%; 24-h 81.4 ± 1.9% (p = 0.7780). Overall survival (OS) at 10 years did not differ with DI: 91.4 ± 1.6% vs. 90.9 ± 1.7% (p = 0.25) without but was higher with the 24-h MTX infusion; 4-h 91.1 ± 1.4%; 24-h 93.9 ± 1.2% (p = 0.0209). MRD predicted outcome; 10-year CCR 87.7 ± 2.2 and 82.1 ± 2.5% when MRD was <0.01% with/without DI (p = 0.007) and 54.3 ± 8% and 44 ± 8% for patients with MRD ≥ 0.01% with/without DI (p = 0.11). DI improved CCR for patients with B-ALL with and without end induction MRD.",2020,Overall survival (OS) at 10 years did not differ with DI: 91.4 ± 1.6% vs. 90.9 ± 1.7% (p = 0.25) without but was higher with the 24-h MTX infusion; 4-h 91.1 ± 1.4%; 24-h 93.9 ± 1.2% (p = 0.0209).,"['eligible National Cancer Institute (NCI) standard (SR) and high-risk (HR) patients', 'Childrens Oncology Group protocols', ""childhood B-ALL: Children's Oncology Group Studies P9904 and P9905"", 'patients with acute lymphoblastic leukemia (ALL) treated on']","['NCI SR', 'dexamethasone', 'MTX', 'BFM', 'intravenous methotrexate (IV MTX']","['Overall survival (OS', 'DI improved CCR', '10-year continuous complete remission']","[{'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.0328713,Overall survival (OS) at 10 years did not differ with DI: 91.4 ± 1.6% vs. 90.9 ± 1.7% (p = 0.25) without but was higher with the 24-h MTX infusion; 4-h 91.1 ± 1.4%; 24-h 93.9 ± 1.2% (p = 0.0209).,"[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Winick', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA. naomi.winick@utsouthwestern.edu.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Martin', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shuster', 'Affiliation': 'Department of Health Outcomes and Policy, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Borowitz', 'Affiliation': 'Department of Pathology and Oncology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Paul Bowman', 'Affiliation': 'Department of Pediatrics, University of North Texas Health Science Center, Fort Worth, TX, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Larsen', 'Affiliation': ""Maine Children's Cancer Program, Scarborough, ME, USA.""}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Pullen', 'Affiliation': 'Department of Pediatrics, University of Mississippi, Jackson, MS, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Carroll', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Willman', 'Affiliation': 'Cancer Center and Departments of Internal Medicine and Pathology, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Department of Pediatrics and the Center for Childhood Cancer Research, Children's Hospital of Philadelphia, and the Perelman School of Medicine at The University of Pennsylvania, Philadelphia, PA, USA.""}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Department of Pediatrics and The Perlmutter Cancer Center, New York University Medical Center, New York, NY, USA.'}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Camitta', 'Affiliation': 'Department of Pediatrics, Midwest Center for Cancer and Blood Disorders, Medical College of Wisconsin, Milwaukee, WI, USA.'}]",Leukemia,['10.1038/s41375-019-0642-2']
404,32232637,Rituximab for very low dose steroid-dependent nephrotic syndrome in children: a randomized controlled study.,"BACKGROUND


Steroid-dependent nephrotic syndrome (SDNS) carries a high risk of toxicity from steroids or steroid-sparing agents. This open-label, randomized controlled trial was designed to test whether the monoclonal antibody rituximab is non-inferior to steroids in maintaining remission in juvenile forms of SDNS and how long remission may last (EudraCT:2008-004486-26).
METHODS


We enrolled 30 children 4-15 years who had developed SDNS 6-12 months before and were maintained in remission with low prednisone doses (0.1-0.4 mg/Kg/day). Participants were randomized following a non-inferiority design to continue prednisone alone (n 15, controls) or to add a single intravenous infusion of rituximab (375 mg/m 2 , n 15 intervention). Prednisone was tapered in both arms after 1 month. Children assigned to the control arm were allowed to receive rituximab to treat disease relapse.
RESULTS


Proteinuria increased at 3 months in the prednisone group (from 0.14 to 1.5 g/day) (p < 0.001) and remained unchanged in the rituximab group (0.14 g/day). Fourteen children in the control arm relapsed within 6 months. Thirteen children assigned to rituximab (87%) were still in remission at 1 year and 8 (53%) at 4 years. Responses were similar in children of the control group who received rituximab to treat disease relapse. We did not record significant adverse events.
CONCLUSIONS


Rituximab was non-inferior to steroids for the treatment of juvenile SDNS. One in two children remains in remission at 4 years following a single infusion of rituximab, without significant adverse events. Further studies are needed to clarify the superiority of rituximab over low-dose corticosteroid as a treatment of SDNS.",2020,"RESULTS


Proteinuria increased at 3 months in the prednisone group (from 0.14 to 1.5 g/day) (p < 0.001) and remained unchanged in the rituximab group (0.14 g/day).","['Thirteen children assigned to', '30 children 4-15\xa0years who had developed SDNS 6-12\xa0months before and were maintained in remission with low prednisone doses (0.1-0.4\xa0mg/Kg/day', 'children', 'Fourteen children in the control arm relapsed within 6\xa0months']","['Prednisone', 'Rituximab', 'prednisone', 'monoclonal antibody rituximab', 'rituximab', 'continue prednisone alone (n 15, controls) or to add a single intravenous infusion of rituximab']",['Proteinuria'],"[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}]","[{'cui': 'C0033687', 'cui_str': 'Proteinuria'}]",13.0,0.136093,"RESULTS


Proteinuria increased at 3 months in the prednisone group (from 0.14 to 1.5 g/day) (p < 0.001) and remained unchanged in the rituximab group (0.14 g/day).","[{'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Ravani', 'Affiliation': 'Division of Nephrology, Faculty of Medicine, Foothills Medical Centre, University of Calgary, 1403-29th Street NW, Calgary, AB, T2N 2T9, Canada. pravani@ucalgary.ca.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Lugani', 'Affiliation': ""Division of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Via Gerolamo Gaslini 5, 16148, Genoa, Italy.""}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Pisani', 'Affiliation': 'Department of Medicine and Surgery, Division of Nephrology, School of Nephrology, University of Parma, Parma, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bodria', 'Affiliation': ""Division of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Via Gerolamo Gaslini 5, 16148, Genoa, Italy.""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Piaggio', 'Affiliation': ""Division of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Via Gerolamo Gaslini 5, 16148, Genoa, Italy.""}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Bartolomeo', 'Affiliation': 'Department of Medicine and Surgery, Division of Nephrology, School of Nephrology, University of Parma, Parma, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Prunotto', 'Affiliation': 'School of Pharmaceutical Sciences, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Gian Marco', 'Initials': 'GM', 'LastName': 'Ghiggeri', 'Affiliation': ""Division of Nephrology, Dialysis, Transplantation, Giannina Gaslini Children's Hospital, Via Gerolamo Gaslini 5, 16148, Genoa, Italy. GMarcoGhiggeri@ospedale-gaslini.ge.it.""}]","Pediatric nephrology (Berlin, Germany)",['10.1007/s00467-020-04540-4']
405,31895695,Circadian rhythm phase shifts caused by timed exercise vary with chronotype.,"BACKGROUNDThe circadian system entrains behavioral and physiological rhythms to environmental cycles, and modern lifestyles disrupt this entrainment. We investigated a timed exercise intervention to phase shift the internal circadian rhythm.METHODSIn 52 young, sedentary adults, dim light melatonin onset (DLMO) was measured before and after 5 days of morning (10 hours after DLMO; n = 26) or evening (20 hours after DLMO; n = 26) exercise. Phase shifts were calculated as the difference in DLMO before and after exercise.RESULTSMorning exercise induced phase advance shifts (0.62 ± 0.18 hours) that were significantly greater than phase shifts from evening exercise (-0.02 ± 0.18 hours; P = 0.01). Chronotype also influenced the effect of timed exercise. For later chronotypes, both morning and evening exercise induced phase advances (0.54 ± 0.29 hours and 0.46 ±0.25 hours, respectively). In contrast, earlier chronotypes had phase advances from morning exercise (0.49 ± 0.25 hours) but had phase delays from evening exercise (-0.41 ± 0.29 hours).CONCLUSIONLate chronotypes - those who experience the most severe circadian misalignment - may benefit from phase advances induced by exercise in the morning or evening, but evening exercise may exacerbate circadian misalignment in early chronotypes. Thus, personalized exercise timing prescription, based on chronotype, could alleviate circadian misalignment in young adults.TRIAL REGISTRATIONTrial registration can be found at www.clinicaltrials.gov (NCT04097886).FUNDINGFunding was supplied by NIH grants UL1TR001998 and TL1TR001997, the Barnstable Brown Diabetes and Obesity Center, the Pediatric Exercise Physiology Laboratory Endowment, the Arvle and Ellen Turner Thacker Research Fund, and the University of Kentucky.",2020,RESULTSMorning exercise induced phase advance shifts (0.62 ± 0.18 hours) that were significantly greater than phase shifts from evening exercise (-0.02 ± 0.18 hours; P = 0.01).,"['52 young, sedentary adults', 'young adults']",['timed exercise intervention'],"['dim light melatonin onset (DLMO', 'DLMO']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",52.0,0.0375097,RESULTSMorning exercise induced phase advance shifts (0.62 ± 0.18 hours) that were significantly greater than phase shifts from evening exercise (-0.02 ± 0.18 hours; P = 0.01).,"[{'ForeName': 'J Matthew', 'Initials': 'JM', 'LastName': 'Thomas', 'Affiliation': 'Department of Kinesiology and Health Promotion.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Kern', 'Affiliation': 'Center for Clinical and Translational Science.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Bush', 'Affiliation': 'Center for Clinical and Translational Science.'}, {'ForeName': 'Kristen J', 'Initials': 'KJ', 'LastName': 'McQuerry', 'Affiliation': 'Department of Biostatistics.'}, {'ForeName': 'W Scott', 'Initials': 'WS', 'LastName': 'Black', 'Affiliation': 'Department of Clinical Sciences.'}, {'ForeName': 'Jody L', 'Initials': 'JL', 'LastName': 'Clasey', 'Affiliation': 'Department of Kinesiology and Health Promotion.'}, {'ForeName': 'Julie S', 'Initials': 'JS', 'LastName': 'Pendergast', 'Affiliation': 'Center for Clinical and Translational Science.'}]",JCI insight,['10.1172/jci.insight.134270']
406,31982494,Financial Incentives for Smoking Cessation in Hospitalized Patients: A Randomized Clinical Trial.,"BACKGROUND


Financial incentives for smoking cessation and use of evidence-based therapy may increase quitting rates and reduce health and economic disparities.
METHODS


We randomized a low-income population of 182 hospitalized patients (mean age 58 years, 45% with high school education or less) to enhanced usual care, which included hospital-directed cessation care and Quitline referral or enhanced usual care plus financial incentives. All patients received enhanced usual care, while participants randomized to the financial incentives group were also eligible to receive up to $550 for participation in Quitline counseling ($50), participation in a community-based cessation program ($50), use of pharmacotherapy ($50), and biochemically confirmed smoking cessation at 2 months ($150) and 6 months ($250). Primary outcome was biochemically confirmed smoking cessation at 6 months after hospital discharge.
RESULTS


Total mean payment was $84 (standard deviation [SD] = $133) in the incentive group. The 6-month rate of biochemically confirmed smoking cessation was 19.6% in the incentive group and 8.9% in the enhanced usual care group (odds ratio [OR] 2.56; 95% confidence interval [CI] 0.84 to 7.83, P = 0.10). Participants in the incentive group had higher rates of nicotine replacement therapy use (57.3% vs 31.3%, P = 0.002). Financial incentives did not improve subjective social status but did increase financial stress.
CONCLUSIONS


Rates of bioconfirmed smoking cessation were higher among hospitalized patients randomized to financial incentives compared to usual care alone, but the difference was not significant. Considering the frequency of low payouts and the importance of assistance for successful quitting, future studies should explore the effectiveness of financial incentives sufficiently large to overcome barriers to evidence-based therapy.",2020,"Participants in the incentive group had higher rates of nicotine replacement therapy use (57.3% versus 31.3%, P=0.002).","['Hospitalized Patients', '182 hospitalized patients (mean age 58 years, 45% with high school education or less) to enhanced usual care, which included hospital-directed cessation care and Quitline referral, or enhanced usual care plus financial incentives']","['financial incentives group were also eligible to receive up to $550 for participation in Quitline counseling ($50), participation in a community-based cessation program ($50), use of pharmacotherapy ($50), and biochemically-confirmed smoking cessation']","['6-month rate of biochemically-confirmed smoking cessation', 'higher rates of nicotine replacement therapy use', 'subjective social status', 'financial stress', 'biochemically-confirmed smoking cessation at 6 months after hospital discharge']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0699806', 'cui_str': 'Social status'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]",182.0,0.123893,"Participants in the incentive group had higher rates of nicotine replacement therapy use (57.3% versus 31.3%, P=0.002).","[{'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Ladapo', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at University of California, Los Angeles; Department of Population Health, New York University School of Medicine, New York. Electronic address: jladapo@mednet.ucla.edu.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at University of California, Los Angeles.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'Department of Population Health, New York University School of Medicine, New York; Department of Medicine, VA New York Harbor Healthcare System, New York; Department of Medicine, New York University School of Medicine, New York.'}]",The American journal of medicine,['10.1016/j.amjmed.2019.12.025']
407,32232540,The effects of unilateral and bilateral cerebellar rTMS on human pharyngeal motor cortical activity and swallowing behavior.,"The cerebellum is recognised to bilaterally modulate sensorimotor function and has recently been shown to play a role in swallowing. Unilateral cerebellar repetitive trans-cranial magnetic stimulation (rTMS) excites corticobulbar motor pathways to the pharynx but the effects of bilateral versus unilateral cerebellar rTMS on these pathways are unknown. In this three-part cross-over study, healthy participants (n = 13) were randomly allocated to receive unilateral or bilateral 10 Hz cerebellar rTMS. Participants were intubated with pharyngeal electromyography and/or manometry catheters for motor evoked potentials (MEPs) and pressure recordings. In part 1 of the study, single pulse TMS was used to measure baseline motor cortical pharyngeal MEP (PMEP) and hemispheric cerebellar MEP (CMEP) amplitudes, before cerebellar rTMS was administered. Repeat measures of PMEP amplitude were performed at 15-min intervals for an hour post unilateral and bilateral rTMS. Thereafter, in two further studies, a cortical 'virtual lesion' (V/L) was applied prior to cerebellar rTMS with pre and post PMEPs (part 2) and measurements of swallowing accuracy (part 3) using a behavioural task. Compared to baseline, unilateral and bilateral cerebellar rTMS provoked increases in pharyngeal cortical excitation (P = 0.028, 0.0005, respectively). Bilateral rTMS was significantly more effective than unilateral in causing cortical excitation (P = 0.0005) and in reversing the suppressive neurological (P = 0.0005) and behavioural (P = 0.0005) effects of a cortical V/L. Our findings suggest bilateral cerebellar rTMS has greater facilitatory effects on corticobulbar motor pathways to the pharynx than unilateral stimulation with the potential to be a more effective clinical therapy if its effects are reproduced in populations with neurogenic dysphagia.",2020,Bilateral rTMS was significantly more effective than unilateral in causing cortical excitation (P = 0.0005) and in reversing the suppressive neurological (P = 0.0005) and behavioural (P = 0.0005) effects of a cortical V/L.,['healthy participants (n\u2009=\u200913'],"['unilateral and bilateral cerebellar rTMS', 'unilateral or bilateral 10\xa0Hz cerebellar rTMS', 'Unilateral cerebellar repetitive trans-cranial magnetic stimulation (rTMS', 'pharyngeal electromyography and/or manometry catheters for motor evoked potentials (MEPs) and pressure recordings']","['human pharyngeal motor cortical activity and swallowing behavior', 'PMEP amplitude', 'baseline motor cortical pharyngeal MEP (PMEP) and hemispheric cerebellar MEP (CMEP) amplitudes', 'pharyngeal cortical excitation', 'suppressive neurological']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0941139', 'cui_str': 'Manometer catheter'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0117061', 'cui_str': 'exopolysaccharide, Pseudomonas marginalis'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric (qualifier value)'}, {'cui': 'C0205367', 'cui_str': 'Suppressive (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",13.0,0.0286059,Bilateral rTMS was significantly more effective than unilateral in causing cortical excitation (P = 0.0005) and in reversing the suppressive neurological (P = 0.0005) and behavioural (P = 0.0005) effects of a cortical V/L.,"[{'ForeName': 'Ayodele', 'Initials': 'A', 'LastName': 'Sasegbon', 'Affiliation': 'Gastrointestinal (GI) Sciences, Division of Diabetes, Endocrinology and Gastroenterology, Faculty of Biology, Medicine and Health, School of Medical Sciences, University of Manchester, Salford Royal Hospital (part of the Manchester Academic Health Sciences Center (MAHSC)), Clinical Sciences Building, Eccles Old Road, Salford, M6 8HD, UK.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Smith', 'Affiliation': 'Division of Cardiovascular Sciences, Manchester Centre for Clinical Neurosciences, Lydia Becker Institute of Immunology and Inflammation, University of Manchester, Salford Royal Hospital, Manchester Academic Health Sciences Centre (MAHSC), Salford, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Bath', 'Affiliation': 'Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rothwell', 'Affiliation': 'Sobell Department of Motor Neuroscience and Movement Disorders, University College London, London, UK.'}, {'ForeName': 'Shaheen', 'Initials': 'S', 'LastName': 'Hamdy', 'Affiliation': 'Gastrointestinal (GI) Sciences, Division of Diabetes, Endocrinology and Gastroenterology, Faculty of Biology, Medicine and Health, School of Medical Sciences, University of Manchester, Salford Royal Hospital (part of the Manchester Academic Health Sciences Center (MAHSC)), Clinical Sciences Building, Eccles Old Road, Salford, M6 8HD, UK. shaheen.hamdy@manchester.ac.uk.'}]",Experimental brain research,['10.1007/s00221-020-05787-x']
408,32113878,Benefits of Self-administered Vaginal Dinoprostone 12 Hours before Levonorgestrel-releasing Intrauterine Device Insertion in Nulliparous Adolescents and Young Women: A Randomized Controlled Trial.,"STUDY OBJECTIVE


To assess safety and efficacy of self-administered vaginal dinoprostone 12 hours before a 52-mg levonorgestrel intrauterine device (LNG-IUD) insertion in adolescents and young nulliparous women.
DESIGN


Randomized controlled trial.
SETTING


Tertiary referral hospital.
PARTICIPANTS


Nulliparous adolescents and young women aged 18-22 years.
INTERVENTIONS


Participants were randomly assigned into 2 groups; the dinoprostone group (n = 65) received dinoprostone 3 mg vaginally, and the placebo group (n = 65) received placebo tablets vaginally.
MAIN OUTCOME MEASURES


Primary outcome was pain scores during LNG-IUD insertion measured using a visual analogue scale. Secondary outcomes were pain scores during speculum insertion, tenaculum placement, uterine sounding, and 20 minutes postprocedure, ease of insertion, Women's satisfaction score, need for additional analgesics, and side effects.
RESULTS


The dinoprostone group had significantly lower pain scores during LNG-IUD insertion (2.83 ± 1.08 vs 3.95 ± 1.63), tenaculum placement (2.97 ± 1.41 vs 4.55 ± 1.53) and sounding of uterus (3.55 ± 1.71 vs 5.12 ± 1.37) compared with the placebo group (P < .001). No significant differences were found between both groups regarding anticipated pain scores (P = .85), pain during speculum insertion and 20 minutes postinsertion and insertion duration (P = .53). Women's satisfaction, provider reported ease of insertion, and need for additional analgesia were significantly better among dinoprostone users (P < .001, < .001, and .02, respectively). Side effects and procedure complications were similar for the 2 groups.
CONCLUSION


Self-administered dinoprostone 3 mg vaginally 12 hours before a 52-mg LNG-IUD insertion in nulliparous adolescent and young women effectively reduced pain during insertion and increased women's satisfaction and ease of insertion reported by clinicians.",2020,"No significant differences were found between both groups regarding anticipated pain scores(P= 0.85), pain during speculum insertion and 20 minutes post-insertion and insertion duration(P=0.53).","['Nulliparous adolescents and young women aged 18-22 years', 'adolescents and young nulliparous women', 'nulliparous adolescent and young women', 'nulliparous adolescents and young women', 'Tertiary referral hospital']","['LNG-IUD insertion', 'placebo tablets vaginally', 'self-administered vaginal dinoprostone', 'dinoprostone', 'Dinoprostone', 'levonorgestrel-releasing intrauterine device insertion', 'dinoprostone 3 mg vaginally, and placebo', 'levonorgestrel intrauterine device (LNG-IUD) insertion']","['pain scores(P= 0.85), pain', 'Women satisfaction, provider reported ease of insertion and need for additional analgesia', 'Side effects and procedure complications', 'pain scores', 'pain scores during LNG-IUD insertion measured by visual analog scale (VAS', 'safety and efficacy', 'pain scores during speculum insertion, tenaculum placement, uterine sounding, and 20 minutes postprocedure, ease of insertion, women satisfaction score, need for additional analgesics, and side effects', 'pain']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0012472', 'cui_str': 'prostaglandin E2 alpha'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}, {'cui': 'C1131356', 'cui_str': 'Dinoprostone 3 MG'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4517483', 'cui_str': '0.85 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037816', 'cui_str': 'Speculum'}, {'cui': 'C0180964', 'cui_str': 'Tenaculum'}, {'cui': 'C0175729', 'cui_str': 'Uterine sound, device (physical object)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",,0.8197,"No significant differences were found between both groups regarding anticipated pain scores(P= 0.85), pain during speculum insertion and 20 minutes post-insertion and insertion duration(P=0.53).","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Samy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt. Electronic address: ahmedsamy8233@gmail.com.'}, {'ForeName': 'Ahmed Said', 'Initials': 'AS', 'LastName': 'Ali', 'Affiliation': 'Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Latif', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Fatma Faisal', 'Initials': 'FF', 'LastName': 'Darweesh', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Nevein Kamal', 'Initials': 'NK', 'LastName': 'Ghamry', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Metwally', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Journal of pediatric and adolescent gynecology,['10.1016/j.jpag.2020.02.010']
409,30214064,Increasing genomic literacy among adolescents.,"PURPOSE


Adolescents increasingly need to be ""genomics literate,"" and may engage more with video educational formats than traditional written formats. We conducted a pilot study to assess and compare the impact of two modes of education about genome sequencing (GS) on adolescents' genomic knowledge and genomic-related decisions.
METHODS


Using an online survey, 43 adolescents ages 14-17 years were randomly assigned to watch a video or read a pamphlet about GS. Measures included pre- and postintervention assessment of genomic knowledge, perceived utility of these materials for decisions about participating in genetic research, interest in receiving GS results, and overall satisfaction with these materials. Analyses described results for all participants and compared results between intervention groups.
RESULTS


Self-reported genomic knowledge increased overall (p < 0.001). Postintervention knowledge about GS limitations was higher among video group than pamphlet group participants (p = 0.038). More video group than pamphlet group participants expressed satisfaction with the material's understandability (45% vs. 29%) and suitability (91% vs. 76%). Interest in receiving personal GS results was significantly associated with being female (p = 0.01) and younger (14-15 years vs. 16-17 years) (p = 0.002).
CONCLUSION


A video format may be preferable for increasing genomic literacy among adolescents. Further research with adolescents is needed to better understand how gender and age may impact genomic decisions and preferences.",2019,Postintervention knowledge about GS limitations was higher among video group than pamphlet group participants (p = 0.038).,"['adolescents', '43 adolescents ages 14-17 years']","['video or read a pamphlet about GS', 'education about genome sequencing (GS']","['pre- and postintervention assessment of genomic knowledge, perceived utility of these materials for decisions about participating in genetic research, interest in receiving GS results, and overall satisfaction', 'Postintervention knowledge about GS limitations']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0017428', 'cui_str': 'Genome'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0887950', 'cui_str': 'Genomics'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0243064', 'cui_str': 'Genetic Research'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}]",,0.0617862,Postintervention knowledge about GS limitations was higher among video group than pamphlet group participants (p = 0.038).,"[{'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Sabatello', 'Affiliation': 'Center for Research on Ethical, Legal & Social Implications of Psychiatric, Neurologic & Behavioral Genetics, Department of Psychiatry, Columbia University, New York, NY, USA. ms4075@columbia.edu.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Saskia C', 'Initials': 'SC', 'LastName': 'Sanderson', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Wendy K', 'Initials': 'WK', 'LastName': 'Chung', 'Affiliation': 'Department of Pediatrics, Columbia University, New York, NY, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Appelbaum', 'Affiliation': 'Center for Research on Ethical, Legal & Social Implications of Psychiatric, Neurologic & Behavioral Genetics, Department of Psychiatry, Columbia University, New York, NY, USA.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-018-0275-2']
410,30214066,Use of a novel computerized decision aid for aneuploidy screening: a randomized controlled trial.,"PURPOSE


To assess whether knowledge following use of a decision aid (DA) for aneuploidy screening and testing is inferior to knowledge in women who saw a genetic counselor (GC) only.
METHODS


This is a randomized controlled noninferiority trial of pregnant women at ≤22 weeks. Women who were scheduled for GC were randomly allocated to use a DA before GC or to GC alone. The primary outcome was knowledge score, comparing women who had used the DA only to those who saw GC alone. Analysis was by intent to treat.
RESULTS


Between January and October 2017, 197 women were randomized, 105 to GC only and 92 to DA use before GC. Demographics and baseline knowledge were similar between groups. Mean knowledge score following DA use was not inferior to mean knowledge score following GC only (10.4 vs. 10.6, p = 0.306). Decisional conflict was similar following completion of the DA to following GC only, but was reduced following completion of both the DA and GC compared with GC only (0.22 vs. 1.74, p = 0.003).
CONCLUSION


Knowledge surrounding aneuploidy screening in women who used a DA was not inferior to knowledge in women who underwent GC. Use of the DA in addition to GC reduced decisional conflict.",2019,"Mean knowledge score following DA use was not inferior to mean knowledge score following GC only (10.4 vs. 10.6, p = 0.306).","['aneuploidy screening', 'pregnant women at ≤22 weeks', 'women who saw a genetic counselor (GC) only', 'Between January and October 2017, 197 women were randomized, 105 to GC only and 92 to DA use before GC', 'Women who were scheduled for GC']","['decision aid (DA', 'DA before GC or to GC alone']","['Decisional conflict', 'decisional conflict', 'Mean knowledge score', 'knowledge score']","[{'cui': 'C0002938', 'cui_str': 'Aneuploid'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0587719', 'cui_str': 'Genetic counselor'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0086104', 'cui_str': 'Decision Aids'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",197.0,0.100846,"Mean knowledge score following DA use was not inferior to mean knowledge score following GC only (10.4 vs. 10.6, p = 0.306).","[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Carlson', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA. laura_carlson@med.unc.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Hardisty', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Hocutt', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Vargo', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Campbell', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Elysia', 'Initials': 'E', 'LastName': 'Davis', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Gilmore', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Neeta L', 'Initials': 'NL', 'LastName': 'Vora', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}]",Genetics in medicine : official journal of the American College of Medical Genetics,['10.1038/s41436-018-0283-2']
411,30668322,"Artemisia annua and Artemisia afra tea infusions vs. artesunate-amodiaquine (ASAQ) in treating Plasmodium falciparum malaria in a large scale, double blind, randomized clinical trial.","BACKGROUND AND OBJECTIVE


Prior small-scale clinical trials showed that Artemisia annua and Artemisia afra infusions, decoctions, capsules, or tablets were low cost, easy to use, and efficient in curing malaria infections. In a larger-scale trial in Kalima district, Democratic Republic of Congo, we aimed to show A. annua and/or A. afra infusions were superior or at least equivalent to artesunate-amodiaquine (ASAQ) against malaria.
METHODS


A double blind, randomized clinical trial with 957 malaria-infected patients had two treatment arms: 472 patients for ASAQ and 471 for Artemisia (248 A. annua, 223 A. afra) remained at end of the trial. ASAQ-treated patients were treated per manufacturer posology, and Artemisia-treated patients received 1 l/d of dry leaf/twig infusions for 7 d; both arms had 28 d follow-up. Parasitemia and gametocytes were measured microscopically with results statistically compared among arms for age and gender.
RESULTS


Artemisinin content of A. afra was negligible, but therapeutic responses of patients were similar to A. annua-treated patients; trophozoites cleared after 24  h, but took up to 14 d to clear in ASAQ-treated patients. D28 cure rates defined as absence of parasitemia were for pediatrics 82, 91, and 50% for A. afra, A. annua and ASAQ; while for adults cure rates were 91, 100, and 30%, respectively. Fever clearance took 48  h for ASAQ, but 24  h for Artemisia. From D14-28 no Artemisia-treated patients had microscopically detectable gametocytes, while 10 ASAQ-treated patients remained gametocyte carriers at D28. More females than males were gametocyte carriers in the ASAQ arm but were unaffected in the Artemisia arms. Hemoglobin remained constant at 11 g/dl for A. afra after D1, while for A. annua and ASAQ it decreased to 9-9.5  g/dl. Only 5.0% of Artemisia-treated patients reported adverse effects, vs. 42.8% for ASAQ.
CONCLUSION


A. annua and A. afra infusions are polytherapies with better outcomes than ASAQ against malaria. In contrast to ASAQ, both Artemisias appeared to break the cycle of malaria by eliminating gametocytes. This study merits further investigation for possible inclusion of Artemisia tea infusions as an alternative for fighting and eradicating malaria.",2019,"Only 5.0% of Artemisia-treated patients reported adverse effects, vs. 42.8% for ASAQ.
","['957 malaria-infected patients had two treatment arms: 472 patients for ASAQ and 471 for Artemisia (248 A. annua, 223 A. afra) remained at end of the trial']","['Artemisia annua and Artemisia afra tea infusions vs. artesunate-amodiaquine (ASAQ', 'artesunate-amodiaquine (ASAQ']","['adults cure rates', 'adverse effects', 'Parasitemia and gametocytes', 'Fever clearance', 'D28 cure rates defined as absence of parasitemia', 'Hemoglobin']","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0331308', 'cui_str': 'Sagebrush'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0686899', 'cui_str': 'Sweet Annie'}, {'cui': 'C0331308', 'cui_str': 'Sagebrush'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0686869', 'cui_str': 'Gametocyte'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",957.0,0.338683,"Only 5.0% of Artemisia-treated patients reported adverse effects, vs. 42.8% for ASAQ.
","[{'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Munyangi', 'Affiliation': 'Faculté de Médecine Université de Kolwezi-Lualaba, Congo DRC.'}, {'ForeName': 'Lucile', 'Initials': 'L', 'LastName': 'Cornet-Vernet', 'Affiliation': ""Vice Présidente de La Maison de l'Artemisia(association Loi 1901), 20 rue Pierre Demours, 75017Paris, France. Electronic address: lcv@maison-artemisia.org.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Idumbo', 'Affiliation': 'Centre de Santé de Lubile, Maniema, Congo DRC.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Department of Mathematics, Worcester Polytechnic Institute, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Lutgen', 'Affiliation': 'Association IFVB-BELHERB, Luxembourg.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Perronne', 'Affiliation': 'Faculté de Médecine de Paris IDF Ouest, France.'}, {'ForeName': 'Nadège', 'Initials': 'N', 'LastName': 'Ngombe', 'Affiliation': 'Faculté de Pharmacie, Université de Kinshasa, Congo DRC.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Bianga', 'Affiliation': 'Programme National Lutte Contre le Paludisme, Maniema, Congo DRC.'}, {'ForeName': 'Bavon', 'Initials': 'B', 'LastName': 'Mupenda', 'Affiliation': 'Ecole de Santé Publique Université de Kinshasa, Congo DRC.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lalukala', 'Affiliation': 'Ministère Provincial de Santé Publique Maniema, Congo DRC.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Mergeai', 'Affiliation': 'Université de Liège, Belgium.'}, {'ForeName': 'Dieudonné', 'Initials': 'D', 'LastName': 'Mumba', 'Affiliation': 'Faculté de Médecine Université de Kinshasa, Congo DRC.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Towler', 'Affiliation': 'Department of Biology and Biotechnology, Worcester Polytechnic Institute, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Weathers', 'Affiliation': 'Department of Biology and Biotechnology, Worcester Polytechnic Institute, USA.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2018.12.002']
412,31880734,"Air Pollution, Physical Activity, and Cardiovascular Function of Patients With Implanted Cardioverter Defibrillators: A Randomized Controlled Trial of Indoor Versus Outdoor Activity.","OBJECTIVE


To investigate whether implanted cardioverter defibrillator (ICD) patients exercising indoors on higher air pollution (AP) days had reduced adverse cardiovascular effects compared with those exercising outdoors.
METHODS


Eighteen participants were randomly divided into control or intervention groups. Blood pressure (BP), pulse rate (PR), and oxygen saturation (O2SAT) were measured daily before and after participants walked outdoors for 30 minutes. On days with higher forecast AP the intervention group exercised indoors.
RESULTS


AP was significantly associated with increased BP and PR, and reduced O2SAT. After adjustment for exercise levels, AP was associated with increased diastolic BP and PR in controls only. Significant improvements in cardiovascular measures over time were observed in both groups.
CONCLUSION


In ICD patients, reducing AP exposure may reduce adverse cardiovascular effects, while daily mild exercise may benefit cardiovascular function.",2020,"Significant improvements in cardiovascular measures over time were observed in both groups.
","['Eighteen participants', 'Patients with Implanted Cardioverter Defibrillators']","['Indoor Versus Outdoor Activity', 'implanted cardioverter defibrillator (ICD) patients exercising indoors']","['BP and PR, and reduced O2SAT', 'diastolic BP and PR', 'cardiovascular measures', 'Air Pollution, Physical Activity and Cardiovascular Function', 'Blood pressure (BP), pulse rate (PR) and oxygen saturation (O2SAT', 'adverse cardiovascular effects']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0199659', 'cui_str': 'Cardiovascular measure'}, {'cui': 'C0001873', 'cui_str': 'Air Pollution'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",18.0,0.0264991,"Significant improvements in cardiovascular measures over time were observed in both groups.
","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Environmental Health Science and Research Bureau, Healthy Environments and Consumer Safety Branch, Health Canada, Ottawa (Dr Liu, Dr Chen, Mr Smith-Doiron, Dr Stieb); Division of Occupational and Environmental Health, Dalla Lana School of Public Health, University of Toronto (Dr Urch, Dr Brook, Ms Speck, Dr Silverman), Southern Ontario Centre for Atmospheric Aerosol Research (SOCAAR) (Dr Urch, Dr Brook, Dr Silverman); University Health Network (Dr Nanthakumar); Environment and Climate Change Canada (Dr Brook), Toronto, Ontario, Canada.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Urch', 'Affiliation': ''}, {'ForeName': 'Kumaraswamy', 'Initials': 'K', 'LastName': 'Nanthakumar', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Smith-Doiron', 'Affiliation': ''}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Brook', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Speck', 'Affiliation': ''}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Silverman', 'Affiliation': ''}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Stieb', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001795']
413,31215755,"Safety, Tolerability, and Pharmacokinetics of the β-Site Amyloid Precursor Protein-Cleaving Enzyme 1 Inhibitor Verubecestat (MK-8931) in Healthy Elderly Male and Female Subjects.","β-site amyloid precursor protein-cleaving enzyme 1 (BACE1) is required for the production of β-amyloid peptides, which are implicated in the etiology of Alzheimer's disease. The safety and pharmacokinetics of the BACE1 inhibitor verubecestat have previously been studied in young adults aged 19-45 years. In this randomized, placebo-controlled, phase I study (protocol MK-8931-006), we investigated the safety, tolerability, and pharmacokinetics of a single dose (100 mg) or multiple doses (30, 80, and 120 mg) once daily for 28 days of verubecestat in healthy elderly subjects. Safety end points were assessed at baseline and during the duration of the study period and indicated that verubecestat was generally well tolerated. Verubecestat pharmacokinetics were similar between healthy elderly male and female subjects and similar to those reported in healthy young males in previous studies. These data supported subsequent studies to assess the potential efficacy of verubecestat in subjects with Alzheimer's disease.",2019,"β-site amyloid precursor protein-cleaving enzyme 1 (BACE1) is required for the production of β-amyloid peptides, which are implicated in the etiology of Alzheimer's disease.","['young adults aged 19-45\xa0years', 'healthy elderly subjects', 'healthy elderly male and female subjects', 'Healthy Elderly Male and Female Subjects', ""subjects with Alzheimer's disease""]","['Enzyme 1 Inhibitor Verubecestat (MK-8931', 'placebo']","['tolerated', 'safety, tolerability, and pharmacokinetics', 'Safety, Tolerability, and Pharmacokinetics of the β-Site Amyloid Precursor Protein-Cleaving']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0686754', 'cui_str': 'Well male elder (finding)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]","[{'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4307343', 'cui_str': 'verubecestat'}, {'cui': 'C4305834', 'cui_str': 'MK-8931'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205242', 'cui_str': 'Cleaved (qualifier value)'}]",,0.0640783,"β-site amyloid precursor protein-cleaving enzyme 1 (BACE1) is required for the production of β-amyloid peptides, which are implicated in the etiology of Alzheimer's disease.","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Forman', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Palcza', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Tseng', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Stone', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Walker', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Swearingen', 'Affiliation': 'Celerion, Tempe, Arizona, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Troyer', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Marissa F', 'Initials': 'MF', 'LastName': 'Dockendorf', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}]",Clinical and translational science,['10.1111/cts.12645']
414,31015198,Phase II Trial of Chemopreventive Effects of Levonorgestrel on Ovarian and Fallopian Tube Epithelium in Women at High Risk for Ovarian Cancer: An NRG Oncology Group/GOG Study.,"A large body of epidemiologic evidence has shown that use of progestin-containing preparations lowers ovarian cancer risk. The purpose of the current study was to gather further preclinical evidence supporting progestins as cancer chemopreventives by demonstrating progestin-activation of surrogate endpoint biomarkers pertinent to cancer prevention in the genital tract of women at increased risk of ovarian cancer. There were 64 women enrolled in a multi-institutional randomized trial who chose to undergo risk-reducing bilateral salpingo-oophorectomy (BSO) and to receive the progestin levonorgestrel or placebo for 4 to 6 weeks prior to undergoing BSO. The ovarian and fallopian tube epithelia (FTE) were compared immunohistochemically for effects of levonorgestrel on apoptosis (primary endpoint). Secondary endpoints included TGFβ isoform expression, proliferation, and karyometric features of nuclear abnormality. In both the ovary and fallopian tube, levonorgestrel did not confer significant changes in apoptosis or expression of the TGFβ1, 2, or 3 isoforms. In the ovarian epithelium, treatment with levonorgestrel significantly decreased the proliferation index. The mean ovarian Ki-67 value in the placebo arm was 2.027 per 100 cells versus 0.775 per 100 cells in the levonorgestrel arm (two-sided  P  value via Mann-Whitney  U  test = 0.0114). The karyometric signature of nuclei in both the ovarian and FTE deviated significantly from normal controls (women at average risk of ovarian cancer), but was significantly less abnormal in women treated with levonorgestrel. These karyometric data further support the idea that progestins may clear genetically abnormal cells and act as chemopreventive agents against ovarian and fallopian tube cancer.",2019,"In both the ovary and fallopian tube, levonorgestrel did not confer significant changes in apoptosis or expression of the TGFβ1, 2, or 3 isoforms.","['Women at High Risk for Ovarian Cancer', '64 women enrolled in a multi-institutional randomized trial who chose to']","['placebo', 'levonorgestrel', 'Levonorgestrel', 'progestin-containing preparations', 'undergo risk-reducing bilateral salpingo-oophorectomy (BSO', 'progestin levonorgestrel or placebo']","['ovarian and fallopian tube epithelia (FTE', 'Ovarian and Fallopian Tube Epithelium', 'proliferation index', 'TGFβ isoform expression, proliferation, and karyometric features of nuclear abnormality', 'mean ovarian Ki-67 value']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C3266262', 'cui_str': 'Multi'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0195495', 'cui_str': 'Bilateral salpingectomy with oophorectomy (procedure)'}]","[{'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0014609', 'cui_str': 'Epithelial Tissue'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0597298', 'cui_str': 'Isoforms'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",64.0,0.125864,"In both the ovary and fallopian tube, levonorgestrel did not confer significant changes in apoptosis or expression of the TGFβ1, 2, or 3 isoforms.","[{'ForeName': 'Gustavo C', 'Initials': 'GC', 'LastName': 'Rodriguez', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston, Illinois. grodriguez@northshore.org.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kauderer', 'Affiliation': 'NRG Oncology, Clinical trial Development Division, Biostatistics & Bioinformatics, Roswell Park Cancer Institute; Buffalo, New York.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hunn', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Larry G', 'Initials': 'LG', 'LastName': 'Thaete', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Watkin', 'Affiliation': 'Department of Pathology, NorthShore University Health System, Evanston, Illinois.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Russell', 'Affiliation': 'Cancer Prevention and Control, University of Arizona Cancer Center, Phoenix, Arizona.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Yozwiak', 'Affiliation': 'Cancer Prevention and Control, University of Arizona Cancer Center, Phoenix, Arizona.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Basil', 'Affiliation': 'TriHealth Hospitals, Cincinnati, Ohio.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hurteau', 'Affiliation': 'Division of Gynecologic Oncology, NorthShore University HealthSystem, Evanston, Illinois.'}, {'ForeName': 'Shashikant', 'Initials': 'S', 'LastName': 'Lele', 'Affiliation': 'Gynecologic Oncology, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Modesitt', 'Affiliation': 'Obstetrics and Gynecology, University of Virginia Health System, Charlottesville, Virginia.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Gynecologic Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Hao Helen', 'Initials': 'HH', 'LastName': 'Zhang', 'Affiliation': 'Department of Mathematics, University of Arizona, Department of Mathematics, Phoenix, Arizona.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Bartels', 'Affiliation': 'Department of Optical Sciences, University of Arizona, Optical Sciences, Phoenix, Arizona.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Alberts', 'Affiliation': 'Cancer Prevention and Control, University of Arizona Cancer Center, Phoenix, Arizona.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-18-0383']
415,28108189,The Longitudinal Impact of an Internet Safety Decision Aid for Abused Women.,"INTRODUCTION


Women experiencing intimate partner violence (IPV) navigate complex, dangerous decisions. Tailored safety information and safety planning, typically provided by domestic violence service providers, can prevent repeat IPV exposure and associated adverse health outcomes; however, few abused women access these services. The Internet represents a potentially innovative way to connect abused women with tailored safety planning resources and information. The purpose of this study was to compare safety and mental health outcomes at baseline, 6 months, and 12 months among abused women randomized to: (1) a tailored, Internet-based safety decision aid; or (2) control website (typical safety information available online).
DESIGN


Multistate, community-based longitudinal RCT with one-to-one allocation ratio and blocked randomization. Data were collected March 2011-May 2013 and analyzed June-July 2015.
SETTING/PARTICIPANTS


Currently abused Spanish- or English-speaking women (N=720).
INTERVENTION


A tailored Internet-based safety decision aid included priority-setting activities, risk assessment, and tailored feedback and safety plans. A control website offered typical safety information available online.
MAIN OUTCOME MEASURES


Primary outcomes were decisional conflict, safety behaviors, and repeat IPV; secondary outcomes included depression and post-traumatic stress disorder.
RESULTS


At 12 months, there were no significant group differences in IPV, depression, or post-traumatic stress disorder. Intervention women experienced significantly less decisional conflict after one use (β= -2.68, p=0.042) and greater increase in safety behaviors they rated as helpful from baseline to 12 months (12% vs 9%, p=0.033) and were more likely to have left the abuser (63% vs 53%, p=0.008). Women who left had higher baseline risk (14.9 vs 13.1, p=0.003) found more of the safety behaviors they tried helpful (61.1% vs 47.5%, p<0.001), and had greater reductions in psychological IPV ((11.69 vs 7.5, p=0.001) and sexual IPV (2.41 vs 1.25, p=0.001) than women who stayed.
CONCLUSIONS


Internet-based safety planning represents a promising tool to reduce the public health impact of IPV.",2017,"Women who left had higher baseline risk (14.9 vs 13.1, p=0.003) found more of the safety behaviors","['Abused Women', 'Women experiencing intimate partner violence (IPV', 'domestic violence service providers']",['Internet-based safety decision aid; or (2) control website (typical safety information available online'],"['decisional conflict', 'safety behaviors', 'psychological IPV', 'IPV, depression, or post-traumatic stress disorder', 'sexual IPV', 'safety and mental health outcomes', 'decisional conflict, safety behaviors, and repeat IPV; secondary outcomes included depression and post-traumatic stress disorder']","[{'cui': 'C0242810', 'cui_str': 'Women, Abused'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0206073', 'cui_str': 'Domestic Violence'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0086104', 'cui_str': 'Decision Aids'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0231394', 'cui_str': 'Decisional conflict (finding)'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",,0.165823,"Women who left had higher baseline risk (14.9 vs 13.1, p=0.003) found more of the safety behaviors","[{'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Glass', 'Affiliation': 'Johns Hopkins University School of Nursing, Johns Hopkins Center for Global Health, Baltimore, Maryland. Electronic address: nglass1@jhu.edu.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Perrin', 'Affiliation': 'Johns Hopkins University School of Nursing, Johns Hopkins Center for Global Health, Baltimore, Maryland.'}, {'ForeName': 'Ginger C', 'Initials': 'GC', 'LastName': 'Hanson', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Tina L', 'Initials': 'TL', 'LastName': 'Bloom', 'Affiliation': 'Sinclair School of Nursing at the University of Missouri-Columbia, Columbia, Missouri.'}, {'ForeName': 'Jill T', 'Initials': 'JT', 'LastName': 'Messing', 'Affiliation': 'School of Social Work, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Amber S', 'Initials': 'AS', 'LastName': 'Clough', 'Affiliation': 'Johns Hopkins University School of Nursing, Johns Hopkins Center for Global Health, Baltimore, Maryland.'}, {'ForeName': 'Jacquelyn C', 'Initials': 'JC', 'LastName': 'Campbell', 'Affiliation': 'Johns Hopkins University School of Nursing, Johns Hopkins Center for Global Health, Baltimore, Maryland.'}, {'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Gielen', 'Affiliation': 'Johns Hopkins Center for Injury Research and Policy, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Case', 'Affiliation': 'Johns Hopkins University School of Nursing, Johns Hopkins Center for Global Health, Baltimore, Maryland.'}, {'ForeName': 'Karen B', 'Initials': 'KB', 'LastName': 'Eden', 'Affiliation': 'Pacific Northwest Evidence-based Practice Center, Oregon Health & Science University, Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland, Oregon.'}]",American journal of preventive medicine,['10.1016/j.amepre.2016.12.014']
416,31977921,Evaluation of Interventions to Reduce Firefighter Exposures.,"OBJECTIVE


Evaluate the effectiveness of firefighter exposure reduction interventions.
METHODS


Fireground interventions included use of self-contained breathing apparatus by engineers, entry team wash down, contaminated equipment isolation, and personnel showering and washing of gear upon return to station. Urinary polycyclic aromatic hydrocarbon metabolites (PAH-OHs) were measured after structural fire responses before and after intervention implementation. Separately, infrared sauna use following live-fire training was compared to standard postfire care in a randomized trial.
RESULTS


The fireground interventions significantly reduced mean total urinary postfire PAH-OHs in engineers (-40.4%, 95%CI -63.9%, -2.3%) and firefighters (-36.2%, 95%CI -56.7%, -6.0%) but not captains (-11.3% 95%CI -39.4%, 29.9%). Sauna treatment non-significantly reduced total mean PAH-OHs by -43.5% (95%CI -68.8%, 2.2%).
CONCLUSIONS


The selected fireground interventions reduced urinary PAH-OHs in engineers and firefighters. Further evaluation of infrared sauna treatment is needed.",2020,"Sauna treatment non-significantly reduced total mean PAH-OHs by -43.5% (95%CI -68.8%, 2.2%).
",[],"['self-contained breathing apparatus (SCBA) by engineers, entry team wash down, contaminated equipment isolation, and personnel showering and washing of gear upon return to station', 'firefighter exposure reduction interventions']","['Urinary polycyclic aromatic hydrocarbon metabolites (PAH-OHs', 'total mean PAH-OHs', 'mean total urinary post-fire PAH-OHs in engineers', 'urinary PAH-OHs']",[],"[{'cui': 'C1443874', 'cui_str': 'Self-contained breathing apparatus'}, {'cui': 'C0878517', 'cui_str': 'Engineer'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C0220824', 'cui_str': 'equipment'}, {'cui': 'C0220862', 'cui_str': 'isolation'}, {'cui': 'C0541748', 'cui_str': 'Shower (physical object)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0221459', 'cui_str': 'Fire and Rescue Personnel'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0032458', 'cui_str': 'Polycyclic Hydrocarbons, Aromatic'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0702194', 'cui_str': 'Fire - domestic object'}, {'cui': 'C0878517', 'cui_str': 'Engineer'}]",,0.0915996,"Sauna treatment non-significantly reduced total mean PAH-OHs by -43.5% (95%CI -68.8%, 2.2%).
","[{'ForeName': 'Jefferey L', 'Initials': 'JL', 'LastName': 'Burgess', 'Affiliation': 'Department of Community, Environment and Policy, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, Arizona (Dr Burgess, Dr Griffin, Ms Littau, Ms Dearmon-Moore, Ms Garavito); Department of Chemical and Environmental Engineering, College of Engineering, University of Arizona, Tucson, Arizona (Dr Hoppe-Jones, Mr Beitel, Ms Flahr, Dr Snyder); Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, Arizona (Dr Zhou, Dr Zhai, Ms Jung); Tucson Fire Department, Tucson, Arizona (Captain Gulotta, Deputy Chief Wallentine, Deputy Chief Moore); Scottsdale Fire Department, Scottsdale, Arizona (Assistant Fire Chief Valliere, Captain Weller).'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Hoppe-Jones', 'Affiliation': ''}, {'ForeName': 'Stephanie C', 'Initials': 'SC', 'LastName': 'Griffin', 'Affiliation': ''}, {'ForeName': 'Jin J', 'Initials': 'JJ', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Gulotta', 'Affiliation': ''}, {'ForeName': 'Darin D', 'Initials': 'DD', 'LastName': 'Wallentine', 'Affiliation': ''}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Valliere', 'Affiliation': ''}, {'ForeName': 'Sasha R', 'Initials': 'SR', 'LastName': 'Weller', 'Affiliation': ''}, {'ForeName': 'Shawn C', 'Initials': 'SC', 'LastName': 'Beitel', 'Affiliation': ''}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Flahr', 'Affiliation': ''}, {'ForeName': 'Sally R', 'Initials': 'SR', 'LastName': 'Littau', 'Affiliation': ''}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'Dearmon-Moore', 'Affiliation': ''}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhai', 'Affiliation': ''}, {'ForeName': 'Alesia M', 'Initials': 'AM', 'LastName': 'Jung', 'Affiliation': ''}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Garavito', 'Affiliation': ''}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Snyder', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001815']
417,32223442,Using the theory of self-affirmation and self-regulation strategies of mental contrasting and forming implementation intentions to reduce social anxiety symptoms.,"Background and Objectives:  Based on the results of past research on emotion regulation and positive behavioral change via self-affirmation, it was hypothesized that self-affirmation should help socially anxious individuals to reduce social anxiety symptoms. The effectiveness of a brief self-affirmation intervention framed in terms of implementation intentions (if-then plans with self-affirming cognitions) was compared against forming non-affirming implementation intentions (with distraction as a way of coping) and inactive control condition. Additionally, it was tested whether mental contrasting can augment the impact of the self-affirmation intervention.  Design/Methods:  Participants ( N  = 198, aged 18-45) were randomly assigned to one of three intervention conditions (self-affirming implementation intention, mental contrasting with self-affirming implementation intention, or non-affirming implementation intention) or an inactive control-group. Social anxiety symptoms were assessed at baseline and at one-week post-intervention.  Results:  The difference between the interventions and the control group was substantial. However, there were no differences in the reduction of overall social anxiety levels between the interventions. Each of the interventions produced a statistically significant reduction in social anxiety (Cohen's  d s from -.40 to -.50).  Conclusions:  The results indicate no advantage for self-affirming over non-affirming implementation intentions in reducing social anxiety symptoms. Moreover, no superiority of mental contrasting was found.",2020,Each of the interventions produced a statistically significant reduction in social anxiety (Cohen's  d s from -.40 to -.50).,"['Participants ( N \u2009=\u2009198, aged 18-45']","['intervention conditions (self-affirming implementation intention, mental contrasting with self-affirming implementation intention, or non-affirming implementation intention) or an inactive control-group']","['overall social anxiety levels', 'Social anxiety symptoms', 'social anxiety symptoms', 'social anxiety']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0206555,Each of the interventions produced a statistically significant reduction in social anxiety (Cohen's  d s from -.40 to -.50).,"[{'ForeName': 'Patryk', 'Initials': 'P', 'LastName': 'Łakuta', 'Affiliation': 'Department of Psychology, SWPS University of Social Sciences and Humanities, Warsaw, Poland.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1746283']
418,31004470,Influence of Rifampin-Mediated Organic Anion-Transporting Polypeptide 1B1/1B3 Inhibition on the Pharmacokinetics of Clazosentan.,"Clazosentan is a selective endothelin A receptor antagonist in development for the prevention and treatment of vasospasm postsubarachnoid hemorrhage. It is a substrate of organic anion-transporting polypeptide 1B1/1B3 based on preclinical data. This randomized, double-blind, two-period, cross-over study investigated the pharmacokinetics, safety, and tolerability of an intravenous infusion of clazosentan (15 mg/hour for 3 hours) after the intravenous administration of placebo or rifampin (600 mg/100 mL in 30 minutes). A total of 14 healthy male participants were enrolled resulting in 13 completers. Clazosentan exposure was three to four times higher after organic anion-transporting polypeptide 1B1/1B3 inhibition, as reflected by the geometric mean ratio (90% confidence interval) of area under the plasma concentration-time curve from zero to infinity: 3.88 (3.24-4.65). Clearance and volume of distribution decreased to a similar extent. Elimination half-life was not affected. A similar pattern but a higher incidence and frequency of adverse events were observed when clazosentan was given with rifampin than with placebo.",2019,"Clazosentan exposure was three to four times higher after organic anion-transporting polypeptide 1B1/1B3 inhibition, as reflected by the geometric mean ratio (90% confidence interval) of area under the plasma concentration-time curve from zero to infinity: 3.88 (3.24-4.65).",['14 healthy male participants were enrolled resulting in 13 completers'],"['Rifampin-Mediated Organic Anion-Transporting Polypeptide 1B1/1B3 Inhibition', 'placebo', 'rifampin', 'Clazosentan', 'placebo or rifampin', 'clazosentan']","['pharmacokinetics, safety, and tolerability', 'adverse events', 'Clearance and volume of distribution', 'geometric mean ratio']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}]","[{'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0949791', 'cui_str': 'Organic Anion Transport Polypeptides'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1721268', 'cui_str': 'clazosentan'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",14.0,0.364399,"Clazosentan exposure was three to four times higher after organic anion-transporting polypeptide 1B1/1B3 inhibition, as reflected by the geometric mean ratio (90% confidence interval) of area under the plasma concentration-time curve from zero to infinity: 3.88 (3.24-4.65).","[{'ForeName': 'Pierre-Eric', 'Initials': 'PE', 'LastName': 'Juif', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Voors-Pette', 'Affiliation': 'QPS Netherlands B.V., Groningen, The Netherlands.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Ufer', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dogterom', 'Affiliation': 'QPS Netherlands B.V., Groningen, The Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",Clinical and translational science,['10.1111/cts.12639']
419,30620944,New Strategies of Pulmonary Protection of Preterm Infants in the Delivery Room with the Respiratory Function Monitoring.,"OBJECTIVE


To investigate if the use of a visible respiratory function monitor (RFM) to use lower tidal volumes (Vts) during positive pressure ventilation (PPV) in the delivery room (DR) reduces the need of surfactant administration and invasive mechanical ventilation during the first 72 hours after birth of preterm infants <32 weeks' gestational age (GA).
STUDY DESIGN


Infants <32 weeks' GA ( n  = 106) requiring noninvasive PPV were monitored with a RFM at birth and randomized to visible ( n  = 54) or masked ( n  = 52) display on RFM. Pulmonary data were recorded during the first 10 minutes after birth. Secondary analysis stratified patients by GA (<28, 28-29 +6 , or ≥30 weeks).
RESULTS


Median expiratory Vts during inflations were greater in the masked group (7 mL/kg) than in the visible group (5.8 mL/kg;  p  = 0.001) same as peak inflation pressure (PIP) administered (21.5 vs. 19.7 cmH 2 O;  p  < 0.001). Consequently, minute volumes were greater in the masked group (256 vs. 214 mL/kg/min;  p  < 0.001), with no differences in respiratory rate. These differences were higher in those <30 weeks' GA. There was no difference in the need of surfactant administration or intubation during the first 72 hours of age.
CONCLUSION


Using a RFM in the DR prevents the use of large Vt and PIP during respiratory support inflations, mostly in the more immature newborn infants, but with no other short-term benefits.",2019,"Consequently, minute volumes were greater in the masked group (256 vs. 214 mL/kg/min;  p  < 0.001), with no differences in respiratory rate.","['immature newborn infants', ""preterm infants <32 weeks' gestational age (GA"", ""Infants <32 weeks' GA ( n \u2009=\u2009106) requiring""]","['visible respiratory function monitor (RFM', 'positive pressure ventilation (PPV', 'noninvasive PPV were monitored with a RFM at birth and randomized to visible ( n \u2009=\u200954) or masked ( n \u2009=\u200952) display on RFM', 'surfactant administration and invasive mechanical ventilation']","['Median expiratory Vts during inflations', 'peak inflation pressure', 'need of surfactant administration or intubation', 'minute volumes', 'respiratory rate']","[{'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C1318493', 'cui_str': 'Inflation'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C4543209', 'cui_str': 'Surfactant'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0428679', 'cui_str': 'Minute volume (observable entity)'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}]",,0.128158,"Consequently, minute volumes were greater in the masked group (256 vs. 214 mL/kg/min;  p  < 0.001), with no differences in respiratory rate.","[{'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Zeballos Sarrato', 'Affiliation': 'Division of Neonatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Sánchez Luna', 'Affiliation': 'Division of Neonatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Zeballos Sarrato', 'Affiliation': 'Division of Neonatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Pérez Pérez', 'Affiliation': 'Division of Neonatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Pescador Chamorro', 'Affiliation': 'Division of Neonatology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Jose María', 'Initials': 'JM', 'LastName': 'Bellón Cano', 'Affiliation': 'Division of Neonatology, Department of Statistics Institute for Health Research, Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}]",American journal of perinatology,['10.1055/s-0038-1676828']
420,32168208,Effect of Thyroxine Therapy on Depressive Symptoms Among Women With Subclinical Hypothyroidism.,"OBJECTIVE


To estimate the effect of antenatal treatment of subclinical hypothyroidism on maternal depressive symptoms.
METHODS


We conducted an ancillary study to a multicenter trial in women with singleton pregnancies diagnosed with subclinical hypothyroidism randomized to antenatal thyroxine therapy or placebo. Treatment was discontinued at the end of pregnancy. Women with overt thyroid disease, diabetes, autoimmune disease, and those diagnosed with depression were excluded. Participants were assessed for depressive symptoms using the Center for Epidemiological Studies-Depression scale (CES-D) before starting the study drug (between 11 and 20 weeks of gestation), between 32 and 38 weeks of gestation, and at 1 year postpartum. The primary outcome was maternal depressive symptoms score as assessed using the CES-D. Secondary outcome was the percentage of women who scored 16 or higher on the CES-D, as such a score is considered screen-positive for depression.
RESULTS


Two hundred forty-five (36.2% of parent trial) women with subclinical hypothyroidism were allocated to thyroxine (n=124) or placebo (n=121). Median CES-D scores and the proportion of participants with positive scores were similar at baseline between the two groups. Treatment with thyroxine was not associated with differences in CES-D scores (10 [5-15] vs 10 [5-17]; P=.46) or in odds of screening positive in the third trimester compared with placebo, even after adjusting for baseline scores (24.3% vs 30.1%, adjusted odds ratio 0.63, 95% CI 0.31-1.28, P=.20). At 1 year postpartum, CES-D scores were not different (6 [3-11] vs 6 [3-12]; P=.79), nor was the frequency of screen-positive CES-D scores in the treated compared with the placebo group (9.7% vs 15.8%; P=.19). Treatment with thyroxine during pregnancy was also not associated with differences in odds of screening positive at the postpartum visit compared with placebo even after adjusting for baseline scores. Sensitivity analysis including women who were diagnosed with depression by the postpartum visit did not change the results.
CONCLUSIONS


This study did not achieve its planned sample size, thus our conclusions may be limited, but in this cohort of pregnant women with subclinical hypothyroidism, antenatal thyroxine replacement did not improve maternal depressive symptoms.",2020,Treatment with thyroxine during pregnancy was also not associated with differences in odds of screening positive at the postpartum visit compared with placebo even after adjusting for baseline scores.,"['Women With Subclinical Hypothyroidism', 'women who were diagnosed with depression by the postpartum visit did not change the results', 'women with singleton pregnancies diagnosed with subclinical hypothyroidism randomized to', 'pregnant women with subclinical hypothyroidism', 'Women with overt thyroid disease, diabetes, autoimmune disease, and those diagnosed with depression were excluded', 'Two hundred forty-five (36.2% of parent trial) women with subclinical hypothyroidism']","['antenatal thyroxine therapy or placebo', 'thyroxine', 'Thyroxine Therapy', 'placebo']","['Depressive Symptoms', 'Median CES-D scores', 'maternal depressive symptoms', 'CES-D scores', 'frequency of screen-positive CES-D scores', 'maternal depressive symptoms score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism (disorder)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0040128', 'cui_str': 'Thyroid Diseases'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune Diseases'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0948465', 'cui_str': 'Thyroxine therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0202231', 'cui_str': 'Thyroxine measurement (procedure)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",,0.699866,Treatment with thyroxine during pregnancy was also not associated with differences in odds of screening positive at the postpartum visit compared with placebo even after adjusting for baseline scores.,"[{'ForeName': 'Maged M', 'Initials': 'MM', 'LastName': 'Costantine', 'Affiliation': 'Departments of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas, University of Texas - Southwestern, Dallas, Texas, Northwestern University, Chicago, Illinois, University of Utah Health Sciences Center, Salt Lake City, Utah, Wayne State University, Detroit, Michigan, Columbia University, New York, New York, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Alabama at Birmingham, Birmingham, Alabama; Brown University, Providence, Rhode Island, University of Texas - Houston, Houston, Texas, The Ohio State University, Columbus, Ohio, Case Western Reserve University, Cleveland, Ohio, Oregon Health Sciences University, Portland, Oregon, University of Pittsburgh, Pittsburgh, Pennsylvania, Medical University of South Carolina, Charleston, South Carolina; and the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Thom', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Peaceman', 'Affiliation': ''}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Varner', 'Affiliation': ''}, {'ForeName': 'Yoram', 'Initials': 'Y', 'LastName': 'Sorokin', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': ''}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Boggess', 'Affiliation': ''}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ''}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': ''}, {'ForeName': 'Baha', 'Initials': 'B', 'LastName': 'Sibai', 'Affiliation': ''}, {'ForeName': 'Jay D', 'Initials': 'JD', 'LastName': 'Iams', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Mercer', 'Affiliation': ''}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Tolosa', 'Affiliation': ''}, {'ForeName': 'Steve N', 'Initials': 'SN', 'LastName': 'Caritis', 'Affiliation': ''}, {'ForeName': 'J Peter', 'Initials': 'JP', 'LastName': 'VanDorsten', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003724']
421,31988481,Effectiveness and cost-effectiveness of The Daily Mile on childhood weight outcomes and wellbeing: a cluster randomised controlled trial.,"BACKGROUND


The Daily Mile is designed to increase physical activity levels with children running or walking around school grounds for 15-min daily. It has been adopted by schools worldwide and endorsed as a solution to tackle obesity, despite no robust evidence of its benefits. We conducted a cluster randomised controlled trial to determine its clinical and cost-effectiveness.
METHODS


Forty schools were randomly assigned (1:1) to either the Daily Mile intervention or control group in which only the usual school health and wellbeing activities were implemented. The primary outcome was BMI z-score (BMIz) at 12 months follow-up from baseline, with planned subgroup analysis to examine differential effects. Primary economic analysis outcome was incremental cost per Quality-Adjusted-Life-Year (QALY) gained.
RESULTS


Using a constrained randomisation approach, balanced on school size, baseline BMIz and proportion of pupils eligible for free school meals, 20 schools were allocated to intervention (n = 1,153 participants) and 20 to control (n = 1,127); 3 schools withdrew (2 intervention, 1 control). At 12 months, BMIz data were available for 18 intervention schools (n = 850) and 19 control schools (n = 820 participants). Using intention-to-treat analysis the adjusted mean difference (MD) in BMIz (intervention - control) was -0.036 (95% CI: -0.085 to 0.013, p = 0.146). Pre-specified subgroup analysis showed a significant interaction with sex (p = 0.001) suggesting a moderate size benefit of The Daily Mile in girls (MD -0.097, 95% CI -0.156 to -0.037). This was consistent with the exploratory economic results that showed The Daily Mile to be highly cost-effective in girls (£2,492 per QALY), but not in boys, and overall to have a 76% chance of cost-effectiveness for the whole sample, at the commonly applied UK threshold of £20,000 per QALY.
CONCLUSIONS


Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.",2020,"Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.","['pupils eligible for free school meals, 20 schools', 'Forty schools']","['Daily Mile', 'Daily Mile intervention or control group in which only the usual school health and wellbeing activities were implemented']","['Effectiveness and cost-effectiveness', 'physical activity levels', 'childhood weight outcomes and wellbeing', 'BMI z-score (BMIz', 'BMIz', 'incremental cost per Quality-Adjusted-Life-Year (QALY) gained']","[{'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0331865', 'cui_str': 'Mile (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",40.0,0.246083,"Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Breheny', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Passmore', 'Affiliation': 'Services for Education, Birmingham, B7 4AX, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK. p.adab@bham.ac.uk.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Hemming', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Emma R', 'Initials': 'ER', 'LastName': 'Lancashire', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Frew', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, B15 2TT, UK. e.frew@bham.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-019-0511-0']
422,30609428,The Effect of Distraction during Labor Induction on Timing of Analgesia Request: A Randomized Clinical Trial.,"OBJECTIVE


To assess whether distraction using music and/or video games influences timing of analgesia request and improves pain outcomes in women undergoing labor induction.
STUDY DESIGN


A total of 219 pregnant women with singleton gestation undergoing labor induction with a Foley bulb (FB) at term were randomized to distraction with music and video games via iPod ( n  = 109) or no iPod ( n  = 110). The primary outcome was the time from FB placement to request for pain medication. Secondary outcomes included number of patients requesting pain medication within 6 and 12 hours, type of pain medication received, pain visual analog scale scores, and patient satisfaction. Mann-Whitney's, chi-square, Kaplan-Meier's curves, and Pearson's product moment correlation were used for statistical analysis (significance:  p  < 0.05).
RESULTS


Baseline characteristics were similar between the two groups. There was no difference in the time from FB placement until pain medication request between the groups. There were no significant differences in secondary outcomes. Increased per cent time of iPod use correlated with a longer time until pain medication request ( R   2  = 0.22,  p  = 0.03).
CONCLUSION


We were not able to show that distraction using music and video games delays timing of analgesia request or improve pain outcomes in pregnant women undergoing mechanical labor induction at term.",2019,"Increased per cent time of iPod use correlated with a longer time until pain medication request ( R   2  = 0.22,  p  = 0.03).
","['219 pregnant women with singleton gestation undergoing labor induction with a Foley bulb (FB) at term', 'women undergoing labor induction', 'pregnant women undergoing mechanical labor induction at term']","['distraction using music and/or video games', 'distraction with music and video games via iPod ( n \u2009=\u2009109) or no iPod', 'Distraction during Labor Induction']","['time from FB placement until pain medication request', 'number of patients requesting pain medication within 6 and 12 hours, type of pain medication received, pain visual analog scale scores, and patient satisfaction', 'time from FB placement to request for pain medication', 'pain outcomes', 'time until pain medication request']","[{'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}, {'cui': 'C1449865', 'cui_str': 'Bulb (substance)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}]","[{'cui': 'C1369038', 'cui_str': 'Distraction (procedure)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C2350434', 'cui_str': 'iPOD'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0420258', 'cui_str': 'Medication requested'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0686900', 'cui_str': 'Request for (contextual qualifier) (qualifier value)'}]",219.0,0.331478,"Increased per cent time of iPod use correlated with a longer time until pain medication request ( R   2  = 0.22,  p  = 0.03).
","[{'ForeName': 'C Luke', 'Initials': 'CL', 'LastName': 'Dixon', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, Galveston, Texas.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Monsivais', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, Galveston, Texas.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Chamseddine', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, Galveston, Texas.'}, {'ForeName': 'Gayle', 'Initials': 'G', 'LastName': 'Olson', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, Galveston, Texas.'}, {'ForeName': 'Luis D', 'Initials': 'LD', 'LastName': 'Pacheco', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, Galveston, Texas.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, Galveston, Texas.'}, {'ForeName': 'Maged M', 'Initials': 'MM', 'LastName': 'Costantine', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Texas Medical Branch at Galveston, Galveston, Texas.'}]",American journal of perinatology,['10.1055/s-0038-1676974']
423,30565096,"Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes.","BACKGROUND


Oral semaglutide is a novel tablet containing the human glucagon-like peptide-1 (GLP‑1) analogue semaglutide, co-formulated with the absorption enhancer sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC). The safety and pharmacokinetics of oral semaglutide were investigated in two randomised, double-blind, placebo-controlled trials.
METHODS


In a single-dose, first-in-human trial, 135 healthy males received oral semaglutide (2-20 mg semaglutide co-formulated with 150-600 mg SNAC) or placebo with SNAC. In a 10-week, once-daily, multiple-dose trial, 84 healthy males received 20 or 40 mg oral semaglutide (with 300 mg SNAC), placebo, or placebo with SNAC, and 23 males with type 2 diabetes (T2D) received 40 mg oral semaglutide (with 300 mg SNAC), placebo, or placebo with SNAC.
RESULTS


Oral semaglutide was safe and well-tolerated in both trials. The majority of adverse events (AEs) were mild, with the most common AEs being gastrointestinal disorders. In the single-dose trial, semaglutide exposure was highest when co-formulated with 300 mg SNAC. In the multiple-dose trial, semaglutide exposure was approximately twofold higher with 40 versus 20 mg oral semaglutide in healthy males, in accordance with dose proportionality, and was similar between healthy males and males with T2D. The half-life of semaglutide was approximately 1 week in all groups.
CONCLUSION


The safety profile of oral semaglutide was as expected for the GLP-1 receptor agonist drug class. Oral semaglutide co-formulated with 300 mg SNAC was chosen for further clinical development. The pharmacokinetic results supported that oral semaglutide is suitable for once-daily dosing. CLINICALTRIALS.
GOV IDENTIFIERS


NCT01037582, NCT01686945.",2019,"In the single-dose trial, semaglutide exposure was highest when co-formulated with 300 mg SNAC.","['Healthy Subjects and Subjects with Type 2 Diabetes', '135 healthy males received', '23 males with type 2 diabetes (T2D) received', '84 healthy males received', 'healthy males and males with T2D', 'healthy males']","['oral semaglutide (2-20\xa0mg semaglutide co-formulated with 150-600\xa0mg SNAC) or placebo with SNAC', 'placebo', 'Novel Oral Human GLP-1 Analogue, Oral Semaglutide', '20 or 40\xa0mg oral semaglutide (with 300\xa0mg SNAC), placebo, or placebo with SNAC', 'Oral semaglutide co-formulated with 300\xa0mg SNAC', '40\xa0mg oral semaglutide (with 300\xa0mg SNAC), placebo, or placebo with SNAC']","['safe and well-tolerated', 'safety and pharmacokinetics of oral semaglutide']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}]",135.0,0.205655,"In the single-dose trial, semaglutide exposure was highest when co-formulated with 300 mg SNAC.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Granhall', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Donsmark', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.'}, {'ForeName': 'Thalia M', 'Initials': 'TM', 'LastName': 'Blicher', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Golor', 'Affiliation': 'Early Phase Clinical Unit-Berlin, Parexel International GmbH, Klinikum Westend-Haus 18, Spandauer Damm 130, 14050, Berlin, Germany.'}, {'ForeName': 'Flemming L', 'Initials': 'FL', 'LastName': 'Søndergaard', 'Affiliation': 'Novo Nordisk A/S, Alfred Nobels Vej 27, 9220, Aalborg Ø, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Thomsen', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark.'}, {'ForeName': 'Tine A', 'Initials': 'TA', 'LastName': 'Bækdal', 'Affiliation': 'Novo Nordisk A/S, Vandtårnsvej 114, 2860, Søborg, Denmark. tabq@novonordisk.com.'}]",Clinical pharmacokinetics,['10.1007/s40262-018-0728-4']
424,30798376,The effect of male involvement and a prevention of mother-to-child transmission (PMTCT) intervention on depressive symptoms in perinatal HIV-infected rural South African women.,"This study investigated perinatal depressive symptoms among HIV-infected women enrolled in a cluster-randomized, controlled trial in South Africa. Women (n = 1370) attending 12 community health centers were consecutively enrolled in a two-phase (phase 1 = without a male partner, phase 2 = with a male partner) and two-condition (experimental or control) prevention of mother-to-child transmission (PMTCT) intervention. Women were enrolled at 8-24 weeks pregnant and followed postpartum at 6 weeks and 6 and 12 months (retention rate = 69.8%). Antenatally, 45.4% of women were above the 12-point Edinburgh Postnatal Depression Scale (EPDS) cutoff, 30.2% were above the cutoff at 6 weeks, and 34.2% and 36.9% at 6 months and 12 months postpartum, respectively. In multilevel regression analyses, depressive symptoms decreased over time among women in phase 2 participating in the intervention condition, but neither condition nor phase alone was associated with a decrease in depression. Greater HIV stigma, increased psychological intimate partner violence, less male involvement, lower education, and non-adherence during pregnancy were associated with increased depressive symptoms over the perinatal period. Results indicated that women participating had high levels of depressive symptoms (> 40% prenatally and > 30% postnatally), and the combination of the multi-session PMTCT intervention plus male partner participation contributed to a reduction in depressive symptoms. Results suggest that interventions targeting the reduction of depressive symptoms in perinatal HIV-positive women by increasing male involvement and decreasing HIV stigma and intimate partner violence are needed to reduce depression in this vulnerable population.",2020,"Antenatally, 45.4% of women were above the 12-point Edinburgh Postnatal Depression Scale (EPDS) cutoff, 30.2% were above the cutoff at 6 weeks, and 34.2% and 36.9% at 6 months and 12 months postpartum, respectively.","['perinatal HIV-infected rural South African women', 'HIV-infected women enrolled in a cluster-randomized, controlled trial in South Africa', 'Women (n\u2009=\u20091370) attending 12 community health centers were consecutively enrolled in a two-phase (phase 1\u2009=\u2009without a male partner, phase 2\u2009=\u2009with a male partner) and two']","['condition (experimental or control) prevention of mother-to-child transmission (PMTCT) intervention', 'mother-to-child transmission (PMTCT) intervention']","['perinatal depressive symptoms', 'depression', 'depressive symptoms', '12-point Edinburgh Postnatal Depression Scale (EPDS) cutoff', 'HIV stigma and intimate partner violence', 'Greater HIV stigma, increased psychological intimate partner violence, less male involvement, lower education, and non-adherence']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0282474', 'cui_str': 'Mother-to-Child Transmission'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh Postnatal Depression Scale'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}]",,0.0648498,"Antenatally, 45.4% of women were above the 12-point Edinburgh Postnatal Depression Scale (EPDS) cutoff, 30.2% were above the cutoff at 6 weeks, and 34.2% and 36.9% at 6 months and 12 months postpartum, respectively.","[{'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Peltzer', 'Affiliation': 'HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research Council, Pretoria, South Africa. kpeltzer@hsrc.ac.za.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Abbamonte', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Lissa N', 'Initials': 'LN', 'LastName': 'Mandell', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Violeta J', 'Initials': 'VJ', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Tae Kyoung', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Deborah L', 'Initials': 'DL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}]",Archives of women's mental health,['10.1007/s00737-019-00955-7']
425,30646422,Evaluation of the Effect of Low-Dose Aspirin on Biochemical and Biophysical Biomarkers for Placental Disease in Low-Risk Pregnancy: Secondary Analysis of a Multicenter RCT.,"OBJECTIVE


To assess the effect of aspirin use in low-risk pregnancy on: (1) pregnancy-associated plasma protein-A (PAPP-A) and placental-like growth factor (PLGF); (2) urinary albumin-to-creatinine ratio (ACR) and blood pressure; (3) fetal growth parameters; and (4) placental histopathology.
STUDY DESIGN


This secondary analysis from the  T  rial of low-dose aspirin with an  E  arly  S  creening  T  est for preeclampsia and growth restriction randomized controlled trial was based on low-risk nulliparous women randomized at 11 weeks to (1) aspirin 75 mg; (2) no aspirin; and (3) aspirin based on the preeclampsia Fetal Medicine Foundation screening test. At baseline, women underwent assessment of blood pressure, PAPP-A, PLGF, and ACR, repeated 9 to 10 weeks postaspirin, in addition to fetal growth assessment. Gross and histopathological placental analyses were performed in line with Amsterdam criteria.
RESULTS


A total of 445 subjects were included (aspirin  n  = 163 [36.6%]; no aspirin  n  = 282 [63.4%]). Although the fetal-to-placental weight ratio was significantly greater in the aspirin group (7.5 [±1.3] vs. 7.3 [±1.4],  p  = 0.045), as was change in ultrasound assessed estimated fetal weight from second to third trimesters (1,624.5 g [±235.1] vs. 1,606.2 [±189.4],  p  = 0.042), this was invalidated by the lack of a difference in birth weight. Aspirin did not significantly impact on change in serum or urine preeclampsia biomarkers, maternal blood pressure, or placental histopathology.
CONCLUSION


Aspirin use in low-risk pregnancy does not appear to impact on preeclampsia biomarkers, fetal growth, or placental pathology.",2019,"Aspirin did not significantly impact on change in serum or urine preeclampsia biomarkers, maternal blood pressure, or placental histopathology.
","['A total of 445 subjects were included (aspirin  n \u2009=\u2009163 [36.6%]; no aspirin  n \u2009=\u2009282 [63.4', 'Placental Disease in Low-Risk Pregnancy']","['Aspirin', 'aspirin', 'aspirin 75\u2009mg; (2) no aspirin', 'Low-Dose Aspirin']","['preeclampsia biomarkers, fetal growth, or placental pathology', 'change in serum or urine preeclampsia biomarkers, maternal blood pressure, or placental histopathology', 'Gross and histopathological placental analyses', 'fetal-to-placental weight ratio', 'fetal weight', 'birth weight', 'low-risk pregnancy on: (1) pregnancy-associated plasma protein-A (PAPP-A) and placental-like growth factor (PLGF); (2) urinary albumin-to-creatinine ratio (ACR) and blood pressure; (3) fetal growth parameters; and (4) placental histopathology', 'blood pressure, PAPP-A, PLGF, and ACR']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1454756', 'cui_str': 'NO-aspirin'}, {'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0032045', 'cui_str': 'Placenta Disorders'}, {'cui': 'C0404841', 'cui_str': 'Low risk pregnancy (finding)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0983879', 'cui_str': 'Aspirin 75 MG'}, {'cui': 'C1454756', 'cui_str': 'NO-aspirin'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0743925', 'cui_str': 'Fetal Growth'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042037'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0677043', 'cui_str': 'Histopathology (qualifier value)'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0751992', 'cui_str': 'Body Weight, Fetal'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0404841', 'cui_str': 'Low risk pregnancy (finding)'}, {'cui': 'C0032999', 'cui_str': 'Pregnancy-Associated Plasma Protein-A'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",445.0,0.126574,"Aspirin did not significantly impact on change in serum or urine preeclampsia biomarkers, maternal blood pressure, or placental histopathology.
","[{'ForeName': 'Fionnuala', 'Initials': 'F', 'LastName': 'Mone', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, National Maternity Hospital, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Mulcahy', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, National Maternity Hospital, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'McParland', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, National Maternity Hospital, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Downey', 'Affiliation': 'Department of Pathology and Laboratory Medicine, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Culliton', 'Affiliation': 'Department of Pathology and Laboratory Medicine, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Orla C', 'Initials': 'OC', 'LastName': 'Maguire', 'Affiliation': 'Department of Pathology and Laboratory Medicine, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Eoghan E', 'Initials': 'EE', 'LastName': 'Mooney', 'Affiliation': 'Department of Pathology and Laboratory Medicine, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': 'Department of Pathology and Laboratory Medicine, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitzgerald', 'Affiliation': 'Department of Pharmacy, National Maternity Hospital, Dublin, Ireland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Tully', 'Affiliation': 'Department of Obstetrics and Gynaecology, Royal College of Surgeons in Ireland, Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Fergal D', 'Initials': 'FD', 'LastName': 'Malone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Royal College of Surgeons in Ireland, Rotunda Hospital, Dublin, Ireland.'}, {'ForeName': 'Fionnuala M', 'Initials': 'FM', 'LastName': 'McAuliffe', 'Affiliation': 'UCD Perinatal Research Centre, School of Medicine, National Maternity Hospital, University College Dublin, Dublin, Ireland.'}]",American journal of perinatology,['10.1055/s-0038-1677476']
426,30883000,Exposure-Response Analysis of Overall Survival for Tremelimumab in Unresectable Malignant Mesothelioma: The Confounding Effect of Disease Status.,"Tremelimumab, an anti-cytotoxic T-lymphocyte antigen-4 monoclonal antibody that enhances T-cell activation, was evaluated in a randomized, double-blind, placebo-controlled, phase IIb study (NCT01843374) in patients with unresectable malignant mesothelioma. The study demonstrated no clinically meaningful differences in overall survival (OS). The objective of this analysis was to evaluate the relationship of exposure with OS. A population pharmacokinetic (PK) model adequately described the PK data. Three factors (sex, C-reactive protein, and baseline tumor size) were identified as statistically significant PK predictors (P < 0.05 on clearance). A positive association between exposure and OS was observed. However, an association between key baseline factors with OS (regardless of treatment) and imbalances in prognostic factors favoring patients with higher exposure (upper vs. lower PK quartile) was seen. Taken together, these results suggest that the exposure OS relationship observed for tremelimumab in mesothelioma is likely spurious rather than a true association of exposure with efficacy.",2019,The study demonstrated no clinically meaningful differences in overall survival (OS).,"['Unresectable Malignant Mesothelioma', 'patients with unresectable malignant mesothelioma']","['Tremelimumab', 'placebo']","['Overall Survival', 'overall survival (OS']","[{'cui': 'C0345967', 'cui_str': 'Mesothelioma, malignant (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.135061,The study demonstrated no clinically meaningful differences in overall survival (OS).,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Baverel', 'Affiliation': 'MedImmune, Cambridge, UK.'}, {'ForeName': 'Lorin', 'Initials': 'L', 'LastName': 'Roskos', 'Affiliation': 'MedImmune, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Manasa', 'Initials': 'M', 'LastName': 'Tatipalli', 'Affiliation': 'MedImmune, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'MedImmune, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stockman', 'Affiliation': 'AstraZeneca, Macclesfield, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Taboada', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Vicini', 'Affiliation': 'MedImmune, Cambridge, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Horgan', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Narwal', 'Affiliation': 'MedImmune, Gaithersburg, Maryland, USA.'}]",Clinical and translational science,['10.1111/cts.12633']
427,32145412,The Utility of Early Postoperative Neuroimaging in Elective/Semielective Craniotomy Patients: A Single-Arm Prospective Trial.,"BACKGROUND


The necessity and timing of early postoperative imaging (POI) are debated in many studies. Despite the consensus that early POI does not change patient management, these examinations are routinely performed. This is the first prospective study related to POI. Our aims were to assess the necessity of early POI in asymptomatic patients and to verify accuracy of the presented algorithm.
METHODS


This was an algorithm-based prospective single-center study. The algorithm addressed preoperative, perioperative, and postoperative considerations, including estimated pathology type, device placement, and postoperative neurologic change. Early computed tomography scans were obtained in all patients, but if postoperative algorithm indications did not recommend a scan, the treating team was blinded to them, and patient management was conducted based on clinical examinations alone. A neuroradiologist and study-independent neurosurgeon reviewed all the scans.
RESULTS


Of 103 enrolled patients, 88 remained asymptomatic, and 15 experienced symptoms postoperatively. Pathology was present on POI in 1% of the asymptomatic patients and 53% of the symptomatic patients (P < 0.001). In the asymptomatic group, no treatment modifications were made postoperatively. Blinding of the surgical team was not removed, and 20% of the symptomatic patients returned to the operating room because of imaging and neurologic findings. The goal of <5% algorithm failure was reached with statistical significance.
CONCLUSIONS


In asymptomatic postoperative patients in whom early imaging is not performed for oncologic indications, device placement verification, or similar reasons, POI is unnecessary and does not change the management of these patients.",2020,One percent of the asymptomatic and 53% of the symptomatic patients had pathologic POI (p<.001).,"['elective/semi-elective craniotomy patients', 'Out of a 103 enrolled', 'asymptomatic patient']",[],['pathologic POI'],"[{'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0660985', 'cui_str': 'D-Glucose, 2-deoxy-2-((1-oxo-3-((1-oxotetradecyl)oxy)tetradecyl)amino)-, 4-(dihydrogen phosphate) 3-(3-((1-oxotetradecyl)oxy)tetradecanoate), (2(R),3(R))-'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}]",[],"[{'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0443045', 'cui_str': 'Poi (qualifier value)'}]",103.0,0.0666964,One percent of the asymptomatic and 53% of the symptomatic patients had pathologic POI (p<.001).,"[{'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'Ben Zvi', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel. Electronic address: idobenz@gmail.com.'}, {'ForeName': 'Sher', 'Initials': 'S', 'LastName': 'Matsri', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Felzensztein', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Yassin', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Orlev', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Netanel', 'Initials': 'N', 'LastName': 'Ben Shalom', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Gavrielli', 'Affiliation': 'Department of Diagnostic Radiology, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Inbar', 'Affiliation': 'Department of Diagnostic Radiology, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Loeub', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Schwartz', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Rajz', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Novitsky', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kanner', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Shani', 'Initials': 'S', 'LastName': 'Berkowitz', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Sagi', 'Initials': 'S', 'LastName': 'Harnof', 'Affiliation': 'Neurosurgery Department, Rabin Medical Center, Petah Tikva, Israel.'}]",World neurosurgery,['10.1016/j.wneu.2020.02.130']
428,31989965,"Deep tissue massage, strengthening and stretching exercises, and a combination of both compared with advice to stay active for subacute or persistent non-specific neck pain: A cost-effectiveness analysis of the Stockholm Neck trial (STONE).","OBJECTIVE


To evaluate the cost-effectiveness of deep tissue massage ('massage'), strengthening and stretching exercises ('exercises') or a combination of both ('combined therapy') in comparison with advice to stay active ('advice') for subacute and persistent neck pain, from a societal perspective.
METHODS


We conducted a cost-effectiveness analysis alongside a four-arm randomized controlled trial of 619 participants followed-up for one year. Health-related quality of life was measured using EQ-5D-3L and costs were calculated from baseline to one year. The interventions were ranked according to quality adjusted life years (QALYs) in a cost-consequence analysis. Thereafter, an incremental cost per QALY was calculated.
RESULTS


In the cost-consequence analysis, in comparison with advice, exercises resulted in higher QALY gains, and massage and the combined therapy were more costly and less beneficial. Exercises may be a cost-effective treatment compared with advice to stay active if society is willing to pay 17 640 EUR per QALY. However, differences in QALY gains were minimal; on average, participants in the massage group, spent a year in a state of health valued at 0.88, exercises: 0.89, combined therapy: 0.88 and, advice: 0.88.
CONCLUSIONS


Exercises are cost-effective compared to advice given that the societal willingness to pay is above 17 640 EUR per year in full health gained. Massage and a combined therapy are not cost-effective. While exercise appeared to have the best cost/benefit profile, even this treatment had only a modest benefit and treatment innovation is needed. Advice to stay active remains as a good therapeutic alternative from an economical perspective.",2020,"In the cost-consequence analysis, in comparison with advice, exercises resulted in higher QALY gains, and massage and the combined therapy were more costly and less beneficial.","['619 participants followed-up for one year', ""comparison with advice to stay active ('advice') for subacute and persistent neck pain"", 'for subacute or persistent non-specific neck pain']","['Massage', ""deep tissue massage ('massage'), strengthening and stretching exercises ('exercises') or a combination of both ('combined therapy"", 'Deep tissue massage, strengthening and stretching exercises, and a combination of both compared with advice to stay active']","['Health-related quality of life', 'QALY gains']","[{'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}]","[{'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0033972', 'cui_str': 'Psychotherapy, Multiple'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",619.0,0.0812957,"In the cost-consequence analysis, in comparison with advice, exercises resulted in higher QALY gains, and massage and the combined therapy were more costly and less beneficial.","[{'ForeName': 'Oscar Javier', 'Initials': 'OJ', 'LastName': 'Pico-Espinosa', 'Affiliation': 'Musculoskeletal and Sports Injury Epidemiology Center, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden. Electronic address: Oscar.pico.espinosa@ki.se.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Aboagye', 'Affiliation': 'Centre for Musculoskeletal Research, Department of Occupational Health Sciences and Psychology, University of Gävle, Gävle, Sweden; Unit of Intervention and Implementation Research for Worker Health, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Côté', 'Affiliation': 'Faculty of Health Sciences and Centre for the Study of Disability Prevention and Rehabilitation, Ontario Tech University, Toronto, Canada.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Peterson', 'Affiliation': 'Division of Speech and Language Pathology, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lena W', 'Initials': 'LW', 'LastName': 'Holm', 'Affiliation': 'Musculoskeletal and Sports Injury Epidemiology Center, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Jensen', 'Affiliation': 'Unit of Intervention and Implementation Research for Worker Health, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Skillgate', 'Affiliation': 'Musculoskeletal and Sports Injury Epidemiology Center, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden; Naprapathögskola - Scandinavian College of Naprapathic Manual Medicine, Stockholm, Sweden; Department of Health Promotion Sciences, Sophiahemmet University, Stockholm, Sweden.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102109']
429,31999615,"What is the minimal important difference of pain intensity, mandibular function, and headache impact in patients with temporomandibular disorders? Clinical significance analysis of a randomized controlled trial.","BACKGROUND


There are insufficient studies providing Minimal Clinically Important Difference (MCID) for outcomes related to temporomandibular disorders (TMD).
OBJECTIVES


(1) To provide the MCID of outcomes related to TMD using the Global Rating of Change Scale (GRCS) as an anchor. (2) To verify which outcomes can predict a moderate or large response to the treatment.
STUDY DESIGN


Secondary analysis of a randomized controlled trial in subjects with TMD.
METHODS


Sixty-one women with TMD were divided into intervention and control groups. Visual Analogue Scale (VAS), Headache Impact Test (HIT-6), pressure pain thresholds (PPTs) of masticatory muscles, Mandibular Function Impairment Questionnaire (MFIQ), and Craniocervical Flexion Test (CCFT) were collected at baseline and 5-weeks follow-up.
RESULTS


Participants were divided based on their response to the treatment, according to the GRCS. MCID values were provided for subjects that moderately or largely improved to the treatment. MCID was between 0 and 1.90 for orofacial pain, around 2 points for the MFIQ, between 3 and 6.26 points for the HIT-6, around 0.2 kg/cm2 for the PPTs on masticatory muscles, around 2.5 mm for MMO and between 60 and 68 points for CCFT. Orofacial pain and HIT-6 were the most discriminative variables at determining whether patients would largely/moderately improve or would not improve after treatment.
CONCLUSIONS


The values of MCID could be used as guidance for both clinical practice and research. Pain intensity and headache impact were the most predictive outcomes for improvement of the general health status of women with TMD.",2020,"Visual Analogue Scale (VAS), Headache Impact Test (HIT-6), pressure pain thresholds (PPTs) of masticatory muscles, Mandibular Function Impairment Questionnaire (MFIQ), and Craniocervical Flexion Test (CCFT) were collected at baseline and 5-weeks follow-up.
","['patients with temporomandibular disorders', 'Sixty-one women with TMD', 'subjects with TMD']",[],"['Visual Analogue Scale (VAS), Headache Impact Test (HIT-6), pressure pain thresholds (PPTs) of masticatory muscles, Mandibular Function Impairment Questionnaire (MFIQ), and Craniocervical Flexion Test (CCFT', 'MCID values', 'MCID', 'pain intensity, mandibular function, and headache impact', 'Pain intensity and headache impact', 'Global Rating of Change Scale (GRCS', 'Orofacial pain and HIT-6']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}, {'cui': 'C4517832', 'cui_str': 'Sixty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0596020', 'cui_str': 'Does hit (finding)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0024890', 'cui_str': 'Masticatory muscles'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1627359', 'cui_str': 'Flexion test'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0178782', 'cui_str': 'Orofacial Pain'}]",61.0,0.117617,"Visual Analogue Scale (VAS), Headache Impact Test (HIT-6), pressure pain thresholds (PPTs) of masticatory muscles, Mandibular Function Impairment Questionnaire (MFIQ), and Craniocervical Flexion Test (CCFT) were collected at baseline and 5-weeks follow-up.
","[{'ForeName': 'Letícia Bojikian', 'Initials': 'LB', 'LastName': 'Calixtre', 'Affiliation': 'Laboratory of Clinical and Occupational Kinesiology (LACO), Department of Physical Therapy, Federal University of São Carlos (UFSCar), São Carlos, SP, Brazil. Electronic address: lecalixtre@hotmail.com.'}, {'ForeName': 'Ana Beatriz', 'Initials': 'AB', 'LastName': 'Oliveira', 'Affiliation': 'Laboratory of Clinical and Occupational Kinesiology (LACO), Department of Physical Therapy, Federal University of São Carlos (UFSCar), São Carlos, SP, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Alburquerque-Sendín', 'Affiliation': 'Department of Sociosanitary Sciences, Radiology and Physical Medicine, University of Córdoba, GC05 Systemic and Chronic Inflammatory Autoimmune Diseases of the Locomotor System and Connective Tissue, Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Armijo-Olivo', 'Affiliation': 'University of Applied Sciences, Faculty of Business and Social Sciences, Osnabrück, Germany; Faculty of Rehabilitation Medicine/Faculty of Medicine and Dentistry, Department of Physical Therapy, University of Alberta, Edmonton, Canada.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102108']
430,32217272,Letter to the Editor regarding: Does pectoralis minor stretching provide additional benefit over an exercise program in participants with subacromial pain syndrome? A randomized controlled trial.,,2020,,['participants with subacromial pain syndrome'],['exercise program'],[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.20058,,"[{'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Kothiyal', 'Affiliation': 'Department of Musculoskeletal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, 133207, Haryana, India.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'Department of Musculoskeletal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, 133207, Haryana, India. Electronic address: manu.goyal@mmumullana.org.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102126']
431,32217952,Mifepristone Antagonization With Progesterone to Prevent Medical Abortion: A Randomized Controlled Trial.,,2020,,['Medical Abortion'],"['Mifepristone Antagonization', 'Progesterone']",[],"[{'cui': 'C3146283', 'cui_str': 'Medical abortion'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}]",[],,0.194373,,"[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Butterfield-Kalk', 'Affiliation': 'San Antonio, Texas.'}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003786']
432,32217274,Can fibular reposition taping improve balance performance in individuals with chronic ankle instability? A randomized controlled trial.,"BACKGROUND


Lateral ankle sprain results in positional faults in the fibula which are thought to limit accessory motion in the ankle, leading to hypomobility and negatively influencing sensorimotor function and postural control. Although it has been shown that fibular reposition taping (FRT) is effective in the prevention of recurrent lateral ankle sprain, its ability to produce significant changes in balance measures in patients with chronic ankle instability is inconclusive.
OBJECTIVE


This study aimed to determine whether a FRT intervention affects balance performance in patients with chronic ankle instability.
DESIGN


Randomized controlled trial.
METHODS


Sixty individuals with chronic ankle instability were randomly allocated to three groups: FRT, sham taping, or no intervention (control group). Kinesiotape was applied and then re-applied on 3 occasions per week for 2 weeks. Static and dynamic balance were measured with three functional tests before and 1 day after the last session of intervention with the tape removed: single-leg stance test, single-leg hop test for distance, and modified Star Excursion Balance Test (mSEBT).
RESULTS


The results of ANCOVA showed that there were no significant differences between the three groups except for mSEBT reach distance in the posterolateral direction, which was significantly greater in the FRT group than the control group (p = 0.03).
CONCLUSION


Applying FRT for 2 weeks did not significantly affect static or dynamic balance measures in individuals with chronic ankle instability, hence its clinical efficacy to influence balance remains uncertain in this population.
CLINICAL TRIAL REGISTRATION NUMBER


IRCT20171122037576N2.",2020,"Applying FRT for 2 weeks did not significantly affect static or dynamic balance measures in individuals with chronic ankle instability, hence its clinical efficacy to influence balance remains uncertain in this population.
","['individuals with chronic ankle instability', 'patients with chronic ankle instability', 'Sixty individuals with chronic ankle instability']","['Kinesiotape', 'fibular reposition taping (FRT', 'FRT intervention', 'FRT, sham taping, or no intervention (control group', 'fibular reposition taping', 'FRT']","['balance performance', 'mSEBT reach distance', 'Static and dynamic balance', 'static or dynamic balance measures']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",60.0,0.0852608,"Applying FRT for 2 weeks did not significantly affect static or dynamic balance measures in individuals with chronic ankle instability, hence its clinical efficacy to influence balance remains uncertain in this population.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hadadi', 'Affiliation': 'Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Iran; Rehabilitation Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Haghighat', 'Affiliation': 'Department of Physical Therapy, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: haghighat_fa@yahoo.com.'}, {'ForeName': 'Sobhan', 'Initials': 'S', 'LastName': 'Sobhani', 'Affiliation': 'Department of Physical Therapy, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Rehabilitation Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102128']
433,32217275,Effects of midfoot joint mobilization on ankle-foot morphology and function following acute ankle sprain. A crossover clinical trial.,"BACKGROUND


Midfoot joint impairment is likely following lateral ankle sprain (LAS) that may benefit from mobilization.
OBJECTIVE


To investigate the effects of midfoot joint mobilizations and a one-week home exercise program (HEP) compared to a sham intervention and HEP on pain, patient-reported outcomes (PROs), ankle-foot joint mobility, and neuromotor function in young adults with recent LAS.
METHODS


All participants were instructed in a stretching, strengthening, and balance HEP and were randomized a priori to receive midfoot joint mobilizations (forefoot supination, cuboid glide and plantar 1st tarsometatarsal) or a sham laying-of-hands. Changes in pain, physical, psychological, and functional PROs, foot morphology, joint mobility, pain-to-palpation, neuromotor function, and dynamic balance were assessed pre-to-post treatment and one-week following. Participants crossed-over following a one-week washout to receive the alternate treatment and were assessed pre-to-post treatment and one-week following. ANOVAs, t-tests, proportions, and 95% confidence intervals (CI) were calculated to assess changes in outcomes. Cohen's d and 95% CI compared treatment effects at each time-point.
RESULTS


Midfoot joint mobilization had greater effects (p < .05) in reducing pain 1-week post (d = 0.8), and increasing Single Assessment Numeric Evaluation (immediate: d = 0.6) and Global Rating of Change (immediate: d = 0.6) compared to a sham treatment and HEP.
CONCLUSION


Midfoot joint mobilizations and HEP yielded greater pain reduction and perceived improvement compared to sham and is recommended in a comprehensive rehabilitation program following LAS.",2020,"RESULTS


Midfoot joint mobilization had greater effects (p < .05) in reducing pain 1-week post (d = 0.8), and increasing Single Assessment Numeric Evaluation (immediate: d = 0.6) and Global Rating of Change (immediate:","['young adults with recent LAS', 'acute ankle sprain']","['Midfoot joint mobilizations and HEP', 'midfoot joint mobilization', 'midfoot joint mobilizations (forefoot supination, cuboid glide and plantar 1st tarsometatarsal) or a sham laying-of-hands', 'midfoot joint mobilizations and a one-week home exercise program (HEP']","['Global Rating of Change (immediate', 'pain, patient-reported outcomes (PROs), ankle-foot joint mobility, and neuromotor function', 'pain reduction', 'pain, physical, psychological, and functional PROs, foot morphology, joint mobility, pain-to-palpation, neuromotor function, and dynamic balance', 'Single Assessment Numeric Evaluation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0160087', 'cui_str': 'Ankle Sprains'}]","[{'cui': 'C0932074', 'cui_str': 'Midfoot region of foot (body structure)'}, {'cui': 'C0542330', 'cui_str': 'Joint mobilization (observable entity)'}, {'cui': 'C0449198', 'cui_str': 'HEP (body structure)'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0038845', 'cui_str': 'Supination'}, {'cui': 'C0376381', 'cui_str': 'Cuboid Bone'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C0450218', 'cui_str': 'Tarsometatarsal (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1135949', 'cui_str': 'Articulationes pedis'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",,0.112497,"RESULTS


Midfoot joint mobilization had greater effects (p < .05) in reducing pain 1-week post (d = 0.8), and increasing Single Assessment Numeric Evaluation (immediate: d = 0.6) and Global Rating of Change (immediate:","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Fraser', 'Affiliation': 'Department of Kinesiology, University of Virginia, 210 Emmet Street South, Charlottesville, VA, 22904-4407, USA; Warfighter Performance Department, Naval Health Research Center, USA. Electronic address: john.j.fraser8.mil@mail.mil.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Saliba', 'Affiliation': 'Department of Kinesiology, University of Virginia, 210 Emmet Street South, Charlottesville, VA, 22904-4407, USA; Department of Orthopaedic Surgery, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Hart', 'Affiliation': 'Department of Kinesiology, University of Virginia, 210 Emmet Street South, Charlottesville, VA, 22904-4407, USA; Department of Orthopaedic Surgery, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Department of Orthopaedic Surgery, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Hertel', 'Affiliation': 'Department of Kinesiology, University of Virginia, 210 Emmet Street South, Charlottesville, VA, 22904-4407, USA; Department of Orthopaedic Surgery, University of Virginia, Charlottesville, VA, USA.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102130']
434,32217951,Mifepristone Antagonization With Progesterone to Prevent Medical Abortion: A Randomized Controlled Trial.,,2020,,['Medical Abortion'],"['Mifepristone Antagonization', 'Progesterone']",[],"[{'cui': 'C3146283', 'cui_str': 'Medical abortion'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}]",[],,0.194373,,"[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Delgado', 'Affiliation': 'Steno Institute, Escondido, California Steno Institute, El Sobrante, California Steno Institute, Mount Pleasant, North Carolina.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Davenport', 'Affiliation': ''}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Harrison', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003780']
435,31778798,Final Overall Survival and Other Efficacy and Safety Results From ASCEND-3: Phase II Study of Ceritinib in ALKi-Naive Patients With ALK-Rearranged NSCLC.,"INTRODUCTION


The phase II, single-arm ASCEND-3 study assessed the efficacy and safety of ceritinib in anaplastic lymphoma kinase (ALK) inhibitor (ALKi)-naive patients with ALK-rearranged NSCLC who had received at least three previous lines of chemotherapy. Here, we report the final efficacy and safety results.
METHODS


Eligible patients (including those with asymptomatic or neurologically stable brain metastases) received oral ceritinib (750 mg/day, fasted). The primary end point was investigator-assessed overall response rate (ORR). Secondary end points were Blinded Independent Review Committee-assessed ORR; investigator- and Blinded Independent Review Committee-assessed overall intracranial response rate, duration of response, time to response, disease control rate, and progression-free survival (PFS); overall survival (OS); and safety. Exploratory end points included patient-reported outcomes.
RESULTS


Of the 124 patients enrolled, 122 (98.4%) had received previous antineoplastic medications (31 patients [25.0%] received at least three regimens), and 49 (39.5%) had baseline brain metastases. The median follow-up time (data cutoff: January 22, 2018) was 52.1 (range, 48.4-60.1) months. The investigator-assessed ORR was 67.7% (95% confidence interval [CI]: 58.8-75.9), and the median PFS was 16.6 months (95% CI: 11.0-23.2). The median OS was 51.3 months (95% CI: 42.7-55.3). Most common adverse events (all grades, ≥60% of patients, all-causality) were diarrhea (85.5%), nausea (78.2%), and vomiting (71.8%). Overall, 18 patients (14.5%) had an adverse event leading to treatment discontinuation. Health-related quality of life was maintained during ceritinib treatment.
CONCLUSIONS


Ceritinib exhibited prolonged and clinically meaningful OS, PFS, and duration of response in chemotherapy-pretreated (at least three lines), ALKi-naive patients with ALK+ NSCLC. The safety profile was consistent with that reported in previous studies.",2020,"Investigator-assessed ORR was 67.7% (95% CI, 58.8 to 75.9) and median PFS was 16.6 months (95% CI, 11.0 to 23.2).","['ALKi-Naïve Patients', '124 patients enrolled, 122 (98.4%) had received prior', 'Eligible patients (including those with asymptomatic or neurologically stable brain metastases [BM', 'anaplastic lymphoma kinase (ALK) inhibitor (ALKi)-naïve patients with ALK-rearranged non-small-cell lung cancer (NSCLC) who had received ≤ 3 prior lines of chemotherapy', 'January 22, 2018): 52.1 months (range, 48.4-60.1']","['antineoplastic medications', 'oral ceritinib 750 mg/day (fasted']","['median PFS', 'Investigator-assessed ORR', 'Final Overall Survival', 'causality): diarrhea', 'vomiting', 'Health-related quality of life', 'Review Committee (BIRC)-assessed ORR; investigator- and BIRC-assessed overall intracranial response rate, duration of response (DOR), time to response, disease control rate, and progression-free survival (PFS); overall survival (OS); and safety', 'baseline BM', 'Median OS', 'overall response rate (ORR', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0252409', 'cui_str': 'NPM-ALK'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0003392', 'cui_str': 'Chemotherapeutic Anticancer Drug'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3818721', 'cui_str': 'ceritinib'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0015127', 'cui_str': 'causes'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",,0.414064,"Investigator-assessed ORR was 67.7% (95% CI, 58.8 to 75.9) and median PFS was 16.6 months (95% CI, 11.0 to 23.2).","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishio', 'Affiliation': 'Thoracic Medical Oncology Department, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan. Electronic address: mnishio@jfcr.or.jp.'}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Orlov', 'Affiliation': 'Department of Thoracic Oncology, Pavlov First Saint Petersburg State Medical University, St. Petersburg, Russia.'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Division of Hematology and Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chong-Jen', 'Initials': 'CJ', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Chun-Ming', 'Initials': 'CM', 'LastName': 'Tsai', 'Affiliation': 'Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Medical Oncology Department, Hospital Regional Universitario Málaga, Instituto de Investigaciones Biomédicas, Málaga, Spain.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McKeage', 'Affiliation': 'Division of Pharmacology and Clinical Pharmacology, Auckland City Hospital and University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Wu-Chou', 'Initials': 'WC', 'LastName': 'Su', 'Affiliation': 'Department of Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Mok', 'Affiliation': ""Department of Clinical Oncology, The Chinese University of Hong Kong, Shatin, The People's Republic of China.""}, {'ForeName': 'Giorgio V', 'Initials': 'GV', 'LastName': 'Scagliotti', 'Affiliation': 'Department of Oncology, University of Torino, Orbassano, Torino, Italy.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': 'Medical Oncology, Sarah Cannon Research Institute, Nashville, Tennessee.'}, {'ForeName': 'Kalyanee', 'Initials': 'K', 'LastName': 'Viraswami-Appanna', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Vanessa Q', 'Initials': 'VQ', 'LastName': 'Passos', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Alice T', 'Initials': 'AT', 'LastName': 'Shaw', 'Affiliation': 'Department of Medicine and Pathology, Massachusetts General Hospital, Boston, Massachusetts.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.11.006']
436,31808785,Framing the Opioid Crisis: Do Racial Frames Shape Beliefs of Whites Losing Ground?,"CONTEXT


Although research has begun to examine perceptions of being on the losing side of politics, it has been confined to electoral politics. The context of health disparities, and particularly the opioid crisis, offers a case to explore whether frames that emphasize racial disadvantage activate loser perceptions and the political consequences of such beliefs.
METHODS


White survey participants (N = 1,549) were randomized into three groups: a control which saw no news article, or one of two treatment groups which saw a news article about the opioid crisis framed to emphasize either the absolute rates of opioid mortality among whites or the comparative rates of opioid mortality among whites compared to blacks.
FINDINGS


Among control group participants, perceiving oneself a political loser was unrelated to attitudes about addressing opioids, whereas those who perceived whites to be on the losing side of public health had a less empathetic response to the opioid crisis. The comparative frame led to greater beliefs that whites are on the losing side of public health, whereas the absolute frame led to more empathetic policy opinions.
CONCLUSIONS


Perceptions that one's racial group has lost ground in the public health context could have political consequences that future research should explore.",2020,"FINDINGS


Among control group participants, perceiving oneself a political loser was unrelated to attitudes about addressing opioids, whereas those who perceived whites to be on the losing side of public health had a less empathetic response to the opioid crisis.","['White survey participants (N\u2009=\u20091,549']",[],['empathetic response'],"[{'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],[],1549.0,0.0142184,"FINDINGS


Among control group participants, perceiving oneself a political loser was unrelated to attitudes about addressing opioids, whereas those who perceived whites to be on the losing side of public health had a less empathetic response to the opioid crisis.","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Gollust', 'Affiliation': 'University of Minnesota.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'University of Delaware.'}]","Journal of health politics, policy and law",['10.1215/03616878-8004874']
437,31808786,Public Preferences for New Information on Opioids.,"CONTEXT


Educating the public through information campaigns is a commonly used policy approach to public health problems. Yet, experimental methods that assess the impact of information campaigns may misestimate their effects by failing to account for respondents' willingness to receive new information.
METHODS


This article uses a doubly randomized survey experiment conducted on a nationally representative sample, where some subjects are randomly assigned to an informational treatment about opioids while other subjects are given the choice of whether to receive treatment or not, to examine how public willingness to seek new information shapes the way they update their preferences about policies related to the opioid epidemic.
FINDINGS


Among those likely to receive information, treatment has a large positive effect on increasing support for policies that address the opioid epidemic by about one half of a standard deviation. Among those who would avoid this information, preferences appear to be unmoved by treatment. These effects would be missed by standard experimental designs.
CONCLUSION


While redressing information asymmetries is only one part of a public health strategy for addressing the opioid epidemic, our findings highlight the importance of access to and receptiveness toward new information.",2020,"Among those likely to receive information, treatment has a large positive effect on increasing support for policies that address the opioid epidemic by about one half of a standard deviation.",[],[],[],[],[],[],,0.0422388,"Among those likely to receive information, treatment has a large positive effect on increasing support for policies that address the opioid epidemic by about one half of a standard deviation.","[{'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Testa', 'Affiliation': 'Brown University.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Moffitt', 'Affiliation': 'Brown University.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Schenk', 'Affiliation': 'Brown University.'}]","Journal of health politics, policy and law",['10.1215/03616878-8004898']
438,32220595,Dexamethasone solution and dexamethasone in Mucolox for the treatment of oral lichen planus: a preliminary study.,"OBJECTIVE


The objective of this single-center, open-label, randomized, phase II study was to evaluate the safety and efficacy of dexamethasone 0.1 mg/mL solution in Mucolox (arm A) compared with dexamethasone 0.1 mg/mL solution alone (arm B) for treatment of oral lichen planus (OLP).
STUDY DESIGN


Patients with clinical OLP and visual analog scale (VAS) sensitivity scores 7 or greater were randomized to arm A or B. Reticulation/erythema/ulcer (REU) scores, VAS for sensitivity and the Chronic Oral Mucosal Diseases Questionnaire (COMDQ) were completed at the baseline and the end of treatment (4 weeks). Differences were assessed by using Wilcoxon's rank-sum test.
RESULTS


Twenty-four patients (females n = 21; median age 64.5 years; range 45-80 years) were randomly assigned to arm A or B. Four patients were excluded. Dexamethasone with or without the addition of Mucolox was effective at reducing the REU score, but the Mucolox-containing solution was relatively more effective (6-point reduction vs 4.3-point reduction; P < .001). There was significant improvement in the total COMDQ score in both arms (mean change 1.8 [arm A] vs 2.5 [arm B]). There were no differences in compliance between the 2 study arms (P = .58).
CONCLUSIONS


Dexamethasone 0.1 mg/mL solution in Mucolox was more effective for the management of OLP compared with dexamethasone 0.1 mg/mL solution alone. Larger studies are needed to confirm these preliminary findings.",2020,There was significant improvement in the total COMDQ score in both arms (mean change 1.8,"['oral lichen planus', 'Twenty-four patients (females n\xa0=\xa021; median age 64.5 years; range 45-80 years', 'Patients with clinical OLP and visual analog scale (VAS) sensitivity scores 7 or greater']","['Dexamethasone solution and dexamethasone', 'dexamethasone 0.1 mg/mL solution alone', 'dexamethasone', 'Dexamethasone']","['erythema/ulcer (REU) scores, VAS for sensitivity and the Chronic Oral Mucosal Diseases Questionnaire (COMDQ', 'REU score', 'safety and efficacy', 'total COMDQ score']","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0023643', 'cui_str': 'Lichen condition'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C2746127', 'cui_str': 'Dexamethasone 0.1 MG/ML [Baycadron]'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0151785', 'cui_str': 'Disorder of mucous membrane'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.193386,There was significant improvement in the total COMDQ score in both arms (mean change 1.8,"[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Villa', 'Affiliation': ""Associate Surgeon, Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA; Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, Boston, MA, USA. Electronic address: Avilla@partners.org.""}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Sankar', 'Affiliation': ""Associate Surgeon, Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA; Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, Boston, MA, USA.""}, {'ForeName': 'Gus', 'Initials': 'G', 'LastName': 'Bassani', 'Affiliation': 'Professional Compounding Centers of America, Houston, TX, USA.'}, {'ForeName': 'Lisa Bennett', 'Initials': 'LB', 'LastName': 'Johnson', 'Affiliation': ""Associate Surgeon, Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA; Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, Boston, MA, USA.""}, {'ForeName': 'Herve', 'Initials': 'H', 'LastName': 'Sroussi', 'Affiliation': ""Associate Surgeon, Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, MA, USA; Department of Oral Medicine, Infection and Immunity, Harvard School of Dental Medicine, Boston, MA, USA.""}]","Oral surgery, oral medicine, oral pathology and oral radiology",['10.1016/j.oooo.2020.02.014']
439,32220916,"Combination Therapy With Canagliflozin Plus Liraglutide Exerts Additive Effect on Weight Loss, but Not on HbA 1c , in Patients With Type 2 Diabetes.","OBJECTIVE


To examine the effect of combination therapy with canagliflozin plus liraglutide on HbA 1c , endogenous glucose production (EGP), and body weight versus each therapy alone.
RESEARCH DESIGN AND METHODS


Forty-five patients with poorly controlled (HbA 1c  7-11%) type 2 diabetes mellitus (T2DM) on metformin with or without sulfonylurea received a 9-h measurement of EGP with [3- 3 H]glucose infusion, after which they were randomized to receive  1 ) liraglutide 1.2 mg/day (LIRA),  2 ) canagliflozin 100 mg/day (CANA), or  3 ) liraglutide 1.2 mg plus canagliflozin 100 mg (CANA/LIRA) for 16 weeks. At 16 weeks, the EGP measurement was repeated.
RESULTS


The mean decrease from baseline to 16 weeks in HbA 1c  was -1.67 ± 0.29% ( P  = 0.0001), -0.89 ± 0.24% ( P  = 0.002), and -1.44 ± 0.39% ( P  = 0.004) in patients receiving CANA/LIRA, CANA, and LIRA, respectively. The decrease in body weight was -6.0 ± 0.8 kg ( P  < 0.0001), -3.5 ± 0.5 kg ( P  < 0.0001), and -1.9 ± 0.8 kg ( P  = 0.03), respectively. CANA monotherapy caused a 9% increase in basal rate of EGP ( P  < 0.05), which was accompanied by a 50% increase ( P  < 0.05) in plasma glucagon-to-insulin ratio. LIRA monotherapy reduced plasma glucagon concentration and inhibited EGP. In CANA/LIRA-treated patients, EGP increased by 15% ( P  < 0.05), even though the plasma insulin response was maintained at baseline and the CANA-induced rise in plasma glucagon concentration was blocked.
CONCLUSIONS


These results demonstrate that liraglutide failed to block the increase in EGP caused by canagliflozin despite blocking the rise in plasma glucagon and preventing the decrease in plasma insulin concentration caused by canagliflozin. The failure of liraglutide to prevent the increase in EGP caused by canagliflozin explains the lack of additive effect of these two agents on HbA 1c .",2020,"In CANA/LIRA-treated patients, EGP increased by 15% ( P  < 0.05), even though the plasma insulin response was maintained at baseline and the CANA-induced rise in plasma glucagon concentration was blocked.
","['Patients With Type 2 Diabetes', 'Forty-five patients with poorly controlled (HbA 1c  7-11%) type 2 diabetes mellitus (T2DM) on']","['Canagliflozin Plus Liraglutide', 'liraglutide', 'liraglutide 1.2 mg/day (LIRA);  2 ) canagliflozin 100 mg/day (CANA); or  3 ) liraglutide 1.2 mg plus canagliflozin 100 mg (CANA/LIRA', 'canagliflozin plus liraglutide', 'metformin with or without sulfonylurea received a 9-h measurement of EGP with [3- 3 H]glucose infusion', 'LIRA monotherapy']","['Weight Loss', 'plasma glucagon concentration', 'HbA 1c , endogenous glucose production (EGP), and body weight', 'plasma insulin concentration', 'plasma insulin response', 'plasma glucagon-to-insulin ratio', 'body weight', 'basal rate of EGP', 'EGP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C3556805', 'cui_str': 'canagliflozin 100 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1278023', 'cui_str': 'Plasma glucagon measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0033268'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}]",45.0,0.0331542,"In CANA/LIRA-treated patients, EGP increased by 15% ( P  < 0.05), even though the plasma insulin response was maintained at baseline and the CANA-induced rise in plasma glucagon concentration was blocked.
","[{'ForeName': 'Ali Muhammed', 'Initials': 'AM', 'LastName': 'Ali', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Martinez', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Hussein', 'Initials': 'H', 'LastName': 'Al-Jobori', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Adams', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Triplitt', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX albarado@uthscsa.edu.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Cersosimo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX.'}]",Diabetes care,['10.2337/dc18-2460']
440,29728704,The novel ghrelin receptor inverse agonist PF-5190457 administered with alcohol: preclinical safety experiments and a phase 1b human laboratory study.,"Rodent studies indicate that ghrelin receptor blockade reduces alcohol consumption. However, no ghrelin receptor blockers have been administered to heavy alcohol drinking individuals. Therefore, we evaluated the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and behavioral effects of a novel ghrelin receptor inverse agonist, PF-5190457, when co-administered with alcohol. We tested the effects of PF-5190457 combined with alcohol on locomotor activity, loss-of-righting reflex (a measure of alcohol sedative actions), and on blood PF-5190457 concentrations in rats. Then, we performed a single-blind, placebo-controlled, within-subject human study with PF-5190457 (placebo/0 mg b.i.d., 50 mg b.i.d., 100 mg b.i.d.). Twelve heavy drinkers during three identical visits completed an alcohol administration session, subjective assessments, and an alcohol cue-reactivity procedure, and gave blood samples for PK/PD testing. In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex. Alcohol did not affect blood PF-5190457 concentrations. In humans, all adverse events were mild or moderate and did not require discontinuation or dose reductions. Drug dose did not alter alcohol concentration or elimination, alcohol-induced stimulation or sedation, or mood during alcohol administration. Potential PD markers of PF-5190457 were acyl-to-total ghrelin ratio and insulin-like growth factor-1. PF-5190457 (100 mg b.i.d.) reduced alcohol craving during the cue-reactivity procedure. This study provides the first translational evidence of safety and tolerability of the ghrelin receptor inverse agonist PF-5190457 when co-administered with alcohol. PK/PD/behavioral findings support continued research of PF-5190457 as a potential pharmacological agent to treat alcohol use disorder.",2020,"In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex.","['rats', 'Twelve heavy drinkers']","['PF-5190457', 'placebo', 'PF-5190457 (placebo/0', 'ghrelin receptor inverse agonist', 'PF-5190457 combined with alcohol']","['reduced alcohol craving', 'alcohol consumption', 'locomotor activity, loss-of-righting reflex', 'safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and behavioral effects', 'alcohol concentration or elimination, alcohol-induced stimulation or sedation, or mood', 'blood PF-5190457 concentrations', 'locomotor activity or loss-of-righting reflex']","[{'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}]","[{'cui': 'C4279098', 'cui_str': 'PF-5190457'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0391690', 'cui_str': 'GHSR Protein'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0234156', 'cui_str': 'Righting Response'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005768'}, {'cui': 'C4279098', 'cui_str': 'PF-5190457'}]",,0.0182118,"In rats, PF-5190457 did not interact with the effects of alcohol on locomotor activity or loss-of-righting reflex.","[{'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Lee', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jenica D', 'Initials': 'JD', 'LastName': 'Tapocik', 'Affiliation': 'Section on Molecular Pathophysiology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mwlod', 'Initials': 'M', 'LastName': 'Ghareeb', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Melanie L', 'Initials': 'ML', 'LastName': 'Schwandt', 'Affiliation': 'Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alexandra A', 'Initials': 'AA', 'LastName': 'Dias', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'April N', 'Initials': 'AN', 'LastName': 'Le', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Enoch', 'Initials': 'E', 'LastName': 'Cobbina', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Farinelli', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Bouhlal', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Farokhnia', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Heilig', 'Affiliation': 'Section on Molecular Pathophysiology, Laboratory of Clinical and Translational Studies, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Akhlaghi', 'Affiliation': 'Clinical Pharmacokinetics Research Laboratory, Department of Biomedical & Pharmaceutical Sciences, College of Pharmacy, University of Rhode Island, Kingston, RI, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Leggio', 'Affiliation': 'Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology, National Institute on Alcohol Abuse and Alcoholism and National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA. lorenzo.leggio@nih.gov.'}]",Molecular psychiatry,['10.1038/s41380-018-0064-y']
441,32112591,Histopathology and immunohistochemical analysis of 5-fluorouracil and triamcinolone treated keloids in double-blinded randomized controlled trial.,"Keloids are a major complication related to surgical wound healing and very challenging condition to treat. Many treatment options are available, but the efficacy of the treatment is poor in most of cases and some keloids do not respond to the treatment at all. We compared the efficacy of intralesional 5-fluorouracil (5-FU) and triamcinolone (TAC) injections in a double-blind randomized controlled trial (RCT). Forty-three patients with 50 keloid scars were treated with either intralesional TAC or 5-FU-injections over 6 months. We wanted to find out whether biological features (cell density, cell proliferation rate, vascular density, myofibroblast numbers, steroid hormone receptor expression) in keloids could be used to predict the response to therapy and define the biological changes that take place in patients receiving a response. As there was no statistically significant difference in the remission rate between TAC and 5-FU treatments, all patients were combined and analyzed as responders and nonresponders. Although responders have slightly more myofibroblasts than the nonresponders in their keloids in the pretreatment biopsy samples, we could not identify a single predictive factor that could identify those patients that respond to drug injections. The good clinical response to therapy is associated with the simultaneous reduction of myofibroblasts in the keloid. This study demonstrates that myofibroblasts are reduced in number in those keloids that were responsive to therapy, and that both 5-FU and TAC injections are useful for keloid treatment.",2020,"As there was no statistically significant difference in the remission rate between TAC and 5-FU treatments, all patients were combined and analyzed as responders and non-responders.","['patients receiving a response', 'Forty-three patients with 50 keloid scars']","['5-FU and TAC injections', 'triamcinolone', 'intralesional 5-fluorouracil (5-FU', '5-fluorouracil and triamcinolone', 'TAC) injections', 'intralesional TAC or 5-FU-injections', 'TAC and 5-FU']","['biological features (cell density, cell proliferation rate, vascular density, myofibroblast numbers, steroid hormone receptor expression', 'remission rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0022548', 'cui_str': 'Keloid'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}]","[{'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0162339', 'cui_str': 'Cell Density'}, {'cui': 'C0596290', 'cui_str': 'Cell Proliferation'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0225360', 'cui_str': 'Myofibroblasts'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0301818', 'cui_str': 'Steroid hormone (substance)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",43.0,0.037629,"As there was no statistically significant difference in the remission rate between TAC and 5-FU treatments, all patients were combined and analyzed as responders and non-responders.","[{'ForeName': 'Kriistiina E', 'Initials': 'KE', 'LastName': 'Hietanen', 'Affiliation': 'Department of Musculoskeletal Surgery and Diseases, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Tero A H', 'Initials': 'TAH', 'LastName': 'Järvinen', 'Affiliation': 'Department of Musculoskeletal Surgery and Diseases, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Heini', 'Initials': 'H', 'LastName': 'Huhtala', 'Affiliation': 'Faculty of Social Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Teemu T', 'Initials': 'TT', 'LastName': 'Tolonen', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Ilkka S', 'Initials': 'IS', 'LastName': 'Kaartinen', 'Affiliation': 'Department of Musculoskeletal Surgery and Diseases, Tampere University Hospital, Tampere, Finland.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12803']
442,32272022,Circulating MicroRNAs and Treatment Response in Childhood Asthma.,"Rationale:  Inhaled corticosteroids (ICS) are key treatments for controlling asthma and preventing asthma attacks. However, the responsiveness to ICS varies among individuals. MicroRNAs (miRNAs) have been lauded for their prognostic utility. Objectives:  We hypothesized that circulating miRNAs obtained at baseline/prerandomization in the Childhood Asthma Management Program (CAMP) could serve as biomarkers and biologic mediators of ICS clinical response over the 4-year clinical trial period. Methods:  We selected baseline serum samples from 462 CAMP subjects subsequently randomized to either ICS (budesonide) or placebo. Samples underwent small RNA sequencing, and read counts were normalized and filtered by depth and coverage. Linear regression was used to associate miRNAs with change in FEV 1 % (prebronchodilator FEV 1  as a percent predicted) over the 4-year treatment period in both main effects and interaction models. We validated the function of the top associated miRNAs by luciferase reporter assays of glucocorticoid-mediated transrepression and predicted response to ICS through logistic regression models. Measurements and Main Results:  We identified 7 miRNAs significantly associated with FEV 1 % change ( P  ≤ 0.05) and 15 miRNAs with significant interaction ( P  ≤ 0.05) to ICS versus placebo treatments. We selected three miRNAs for functional validation, of which hsa-miR-155-5p and hsa-miR-532-5p were significantly associated with changes in dexamethasone-induced transrepression of NF-κB. Combined, these two miRNAs were predictive of ICS response over the course of the clinical trial, with an area under the receiver operating characteristic curve of 0.86. Conclusions:  We identified two functional circulating miRNAs predictive of asthma ICS treatment response over time.",2020,We identified 7 miRNAs significantly associated with FEV1% change (p<=0.05) and 15 miRNAs with significant interaction (p<=0.05) to ICS versus placebo treatments.,"['Childhood Asthma', '462 CAMP subjects subsequently randomized to either']","['corticosteroids (ICS', 'placebo', 'ICS (budesonide) or placebo']",['ICS response'],"[{'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",462.0,0.187332,We identified 7 miRNAs significantly associated with FEV1% change (p<=0.05) and 15 miRNAs with significant interaction (p<=0.05) to ICS versus placebo treatments.,"[{'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Channing Division of Network Medicine and.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Panganiban', 'Affiliation': 'Program in Molecular and Integrative Physiological Sciences, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; and.'}, {'ForeName': 'Alvin T', 'Initials': 'AT', 'LastName': 'Kho', 'Affiliation': ""Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'McGeachie', 'Affiliation': 'Channing Division of Network Medicine and.'}, {'ForeName': 'Leanna', 'Initials': 'L', 'LastName': 'Farnam', 'Affiliation': 'Channing Division of Network Medicine and.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Chase', 'Affiliation': 'Channing Division of Network Medicine and.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': 'Channing Division of Network Medicine and.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Program in Molecular and Integrative Physiological Sciences, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; and.'}, {'ForeName': 'Kelan G', 'Initials': 'KG', 'LastName': 'Tantisira', 'Affiliation': 'Channing Division of Network Medicine and.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201907-1454OC']
443,32217783,Energy conservation technique improves dyspnoea when patients with severe COPD climb stairs: a randomised crossover study.,"In this randomised, crossover trial, 22 patients with severe chronic obstructive pulmonary disease climbed six flights of stairs (108 steps) twice, under two test conditions: (1) energy conservation technique (ECT): participants were asked to rest for at least 5 seconds every three steps and (2) control condition: participants climbed the stairs at their own pace. Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition were found, with no change in total task time. CLINICAL TRIAL REGISTRATION: NCT03564028.",2020,"Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition were found, with no change in total task time.","['patients with severe COPD climb stairs', '22 patients with severe chronic obstructive pulmonary disease climbed six flights of stairs (108 steps) twice, under two test conditions: (1']","['Energy conservation technique', 'energy conservation technique (ECT']","['dyspnoea', 'Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition', 'total task time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1290942', 'cui_str': 'Stair Navigation'}, {'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease (disorder)'}, {'cui': 'C0561942', 'cui_str': 'Does climb (finding)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0449910', 'cui_str': 'Test conditions (attribute)'}]","[{'cui': 'C1621943', 'cui_str': 'Energy conservation'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0859235', 'cui_str': 'Lower extremities ill feeling of'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood (substance)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",22.0,0.0844287,"Significant lower dyspnoea (primary outcome), leg discomfort, minute ventilation and capillary blood lactate under the ECT condition were found, with no change in total task time.","[{'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Prieur', 'Affiliation': 'Institute of Experimental and Clinical Research (IREC), Pole of Pulmonology, ORL and Dermatology, Université catholique de Louvain, 1200, Belgium gprieur.kine@gmail.com.'}, {'ForeName': 'Yann', 'Initials': 'Y', 'LastName': 'Combret', 'Affiliation': 'Institute of Experimental and Clinical Research (IREC), Pole of Pulmonology, ORL and Dermatology, Université catholique de Louvain, 1200, Belgium.'}, {'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Medrinal', 'Affiliation': 'Normandie Univ, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), 76 000 Rouen, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Arnol', 'Affiliation': 'ICADOM, AGIR à dom, Meylan, France.'}, {'ForeName': 'Tristan', 'Initials': 'T', 'LastName': 'Bonnevie', 'Affiliation': 'Normandie Univ, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), 76 000 Rouen, France.'}, {'ForeName': 'Francis-Edouard', 'Initials': 'FE', 'LastName': 'Gravier', 'Affiliation': 'Normandie Univ, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), 76 000 Rouen, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Quieffin', 'Affiliation': 'Pulmonology department and pulmonary rehabilitation department, Groupe Hospitalier du Havre, 76290 Montivilliers, France.'}, {'ForeName': 'Bouchra', 'Initials': 'B', 'LastName': 'Lamia', 'Affiliation': 'Normandie Univ, UNIROUEN, EA3830-GRHV, Institute for Research and Innovation in Biomedicine (IRIB), 76 000 Rouen, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reychler', 'Affiliation': 'Institute of Experimental and Clinical Research (IREC), Pole of Pulmonology, ORL and Dermatology, Université catholique de Louvain, 1200, Belgium.'}, {'ForeName': 'Jean-Christian', 'Initials': 'JC', 'LastName': 'Borel', 'Affiliation': 'R&D, AGIR à dom, Meylan, France.'}]",Thorax,['10.1136/thoraxjnl-2019-214295']
444,31466618,Natriuretic Peptide Response and Outcomes in Chronic Heart Failure With Reduced Ejection Fraction.,"BACKGROUND


The GUIDE-IT (GUIDing Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure) trial demonstrated that a strategy to ""guide"" application of guideline-directed medical therapy (GDMT) by reducing amino-terminal pro-B-type natriuretic peptide (NT-proBNP) was not superior to GDMT alone.
OBJECTIVES


The purpose of this study was to examine the prognostic meaning of NT-proBNP changes following heart failure (HF) therapy intensification relative to the goal NT-proBNP value of 1,000 pg/ml explored in the GUIDE-IT trial.
METHODS


A total of 638 study participants were included who were alive and had available NT-proBNP results 90 days after randomization. Rates of subsequent cardiovascular (CV) death/HF hospitalization or all-cause mortality during follow-up and Kansas City Cardiomyopathy Questionnaire (KCCQ) overall scores were analyzed.
RESULTS


A total of 198 (31.0%) subjects had an NT-proBNP ≤1,000 pg/ml at 90 days with no difference in achievement of NT-proBNP goal between the biomarker-guided and usual care arms. NT-proBNP ≤1,000 pg/ml by 90 days was associated with longer freedom from CV/HF hospitalization or all-cause mortality (p < 0.001 for both) and lower adjusted hazard of subsequent HF hospitalization/CV death (hazard ratio: 0.26; 95% confidence interval: 0.15 to 0.46; p < 0.001) and all-cause mortality (hazard ratio: 0.34; 95% confidence interval: 0.15 to 0.77; p = 0.009). Regardless of elevated baseline concentration, an NT-proBNP ≤1,000 pg/ml at 90 days was associated with better outcomes and significantly better KCCQ overall scores (p = 0.02).
CONCLUSIONS


Patients with heart failure with reduced ejection fraction whose NT-proBNP levels decreased to ≤1,000 pg/ml during GDMT had better outcomes. These findings may help to understand the results of the GUIDE-IT trial. (Guiding Evidence Based Therapy Using Biomarker Intensified Treatment [GUIDE-IT]; NCT01685840).",2019,pg/ml by 90 days was associated with longer freedom from CV/HF hospitalization or all-cause mortality (p < 0.001 for both) and lower adjusted hazard of subsequent HF hospitalization/CV death (hazard ratio: 0.26; 95% confidence interval: 0.15 to 0.46; p < 0.001) and all-cause mortality (hazard ratio: 0.34; 95% confidence interval: 0.15 to 0.77; p = 0.009).,"['Heart\xa0Failure', 'A total of 638 study participants were included who were alive and had available NT-proBNP results 90\xa0days after randomization']",['guideline-directed medical therapy (GDMT'],"['longer freedom from CV/HF hospitalization or all-cause mortality', 'Rates of subsequent cardiovascular (CV) death/HF hospitalization or all-cause mortality', 'Cardiomyopathy Questionnaire (KCCQ) overall scores', 'NT-proBNP levels', 'KCCQ overall scores']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",638.0,0.212442,pg/ml by 90 days was associated with longer freedom from CV/HF hospitalization or all-cause mortality (p < 0.001 for both) and lower adjusted hazard of subsequent HF hospitalization/CV death (hazard ratio: 0.26; 95% confidence interval: 0.15 to 0.46; p < 0.001) and all-cause mortality (hazard ratio: 0.34; 95% confidence interval: 0.15 to 0.77; p = 0.009).,"[{'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Januzzi', 'Affiliation': 'Cardiology Division, Massachusetts General Hospital, Baim Institute for Clinical Research, Boston, Massachusetts. Electronic address: JJanuzzi@partners.org.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Ahmad', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University Medical Center, New Haven, Connecticut.'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Coles', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Kirkwood F', 'Initials': 'KF', 'LastName': 'Adams', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Ezekowitz', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, California.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Fiuzat', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Houston-Miller', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Ileana L', 'Initials': 'IL', 'LastName': 'Piña', 'Affiliation': 'Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Gayle', 'Initials': 'G', 'LastName': 'Passmore', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Whellan', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lawton S', 'Initials': 'LS', 'LastName': 'Cooper', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Leifer', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': ""O'Connor"", 'Affiliation': 'Inova Heart and Vascular Center, Fairfax, Virginia.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.06.055']
445,32176061,"Apatinib combined with chemotherapy or concurrent chemo-brachytherapy in patients with recurrent or advanced cervical cancer: A phase 2, randomized controlled, prospective study.","OBJECTIVE


Apatinib mesylate is a novel vascular endothelial growth factor receptor 2 (VEGFR-2) inhibitor, which has exhibited good safety and efficacy in several types of solid tumors. The present study aimed to assess the clinical efficacy and safety of apatinib combined with chemotherapy and concurrent chemo-brachytherapy (CCBT) in patients with recurrent and advanced cervical cancer.
METHODS


A total of 52 patients with first diagnosed recurrent or untreated International Federation of Gynecology and Obstetrics stage IVB cervical cancer admitted at Shandong Cancer Hospital and Institute between July 2016 and May 2018 were analyzed in the current randomized controlled trial. The patients were randomly divided into 2 groups: the apatinib-treated group and the control group. Patients with recurrent cervical cancer in the apatinib-treated group were administered apatinib and carboplatin-paclitaxel as first-line chemotherapy. Patients with advanced cervical cancer were administered apatinib in combination with CCBT. In control group, patients with recurrent cervical cancer were treated with chemotherapy alone while patients with advanced cervical cancer received CCBT.
RESULTS


The progression-free survival was significantly prolonged in apatinib group compared with control group (10.1 months; 95% confidence interval (CI), 8.42-11.79 vs 6.4 months; 95% CI, 3.88-8.92; P < .01; hazard ratio (HR), 0.44; 95% CI, 0.25-0.78; P < .01). The objective response rate in apatinib group was obviously higher than that in control group (64.3% vs 33.3%, P < .05). Proteinuria, hand-foot syndrome, mucositis, and hypertension in all Grades were statistically more common in apatinib group than in control group. Apatinib did not obviously aggravate other radiotherapy or chemotherapy side effects.
CONCLUSION


Apatinib exhibited promising clinical efficacy in cervical cancer patients, resulting in an improved response rate and prolonged progression-free survival compared with the control group, and had manageable side effects. Our study revealed that apatinib combination therapy, adenocarcinoma, and bone metastasis.",2020,"Proteinuria, hand-foot syndrome, mucositis, and hypertension in all Grades were statistically more common in apatinib group than in control group.","['Patients with advanced cervical cancer', 'cervical cancer patients', 'patients with recurrent or advanced cervical cancer', 'Patients with recurrent cervical cancer', 'patients with recurrent and advanced cervical cancer', '52 patients with first diagnosed recurrent or untreated International Federation of Gynecology and Obstetrics stage IVB cervical cancer admitted at Shandong Cancer Hospital and Institute between July 2016 and May 2018', 'patients with recurrent cervical cancer']","['apatinib and carboplatin-paclitaxel as first-line chemotherapy', 'chemotherapy alone', 'CCBT', 'radiotherapy', 'apatinib combined with chemotherapy and concurrent chemo-brachytherapy (CCBT', 'Apatinib combined with chemotherapy or concurrent chemo-brachytherapy']","['clinical efficacy and safety', 'progression-free survival', 'Proteinuria, hand-foot syndrome, mucositis, and hypertension', 'objective response rate', 'response rate and prolonged progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0019999', 'cui_str': 'Hospitals, Cancer'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}]","[{'cui': 'C2346836', 'cui_str': '3-Pyridinecarboxamide, N-(4-(1-cyanocyclopentyl)phenyl)-2-((4-methyl-3-pyridinyl)amino)-'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0006098', 'cui_str': 'Radioisotope Brachytherapy'}]","[{'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0852711', 'cui_str': 'Hand-foot syndrome in sickle cell anemia (disorder)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}]",52.0,0.0580297,"Proteinuria, hand-foot syndrome, mucositis, and hypertension in all Grades were statistically more common in apatinib group than in control group.","[{'ForeName': 'Qiufen', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Obstetrics and Gynecology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan.'}, {'ForeName': 'Yawen', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Education and Cancer Prevention, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, PR China.'}, {'ForeName': 'Enqi', 'Initials': 'E', 'LastName': 'Kong', 'Affiliation': 'Department of Gynecological Oncology.'}, {'ForeName': 'Linli', 'Initials': 'L', 'LastName': 'Rao', 'Affiliation': 'Department of Gynecological Oncology.'}, {'ForeName': 'Jinlong', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Gynecological Oncology.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Gynecological Oncology.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynecological Oncology.'}, {'ForeName': 'Naifu', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Gynecological Oncology.'}, {'ForeName': 'Mingjiang', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Shandong Provincial Hospital Affiliated to Shandong University, Jinan.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Gynecological Oncology, Qingdao Central Hospital, The Second Affiliated Hospital of Qingdao University, Qingdao.'}]",Medicine,['10.1097/MD.0000000000019372']
446,31815582,"Randomized, Phase II Study Prospectively Evaluating Treatment of Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of  ERCC1 : SWOG S1201.","PURPOSE


Platinum-based therapy is the standard of care in patients who have HER2-negative, advanced esophagogastric cancer (AEGC). Retrospective data suggest that intratumoral  ERCC1  levels may determine platinum sensitivity. A randomized, phase II study was performed in patients with AEGC to explore whether the efficacy of a platinum-based therapy with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) versus a non-platinum-containing regimen of irinotecan and docetaxel (IT) differed according to  ERCC1  levels.
PATIENTS AND METHODS


Overall, 202 untreated patients with HER2-negative AEGC and a Zubrod performance status of 0-1 were evaluated prospectively for mRNA expression of  ERCC1  level and then randomly assigned to FOLFOX or IT, stratified by the intratumoral statuses of  ERCC1  low (< 1.7) or high (≥ 1.7). Objectives were to assess progression-free survival (PFS) and overall survival (OS) in all patients treated with FOLFOX compared with IT, stratified by low and high  ERCC1  levels, and to assess for interactive effects between  ERCC1  expression and treatment arm.
RESULTS


Eighty-six percent of patients had  ERCC1  values < 1.7. Thus, evaluation of the  ERCC1 -high subgroup was limited. Grade ≥ 3 anemia, dehydration, diarrhea, and fatigue were greater in patients with IT. Occurrences of grade ≥ 3 neuropathy and decreased neutrophils were greater in patients with FOLFOX. In all patients, FOLFOX had a statistically superior median PFS compared with IT (5.7  v  2.9 months; hazard ratio, 0.68;  P  = .02). In patients with  ERCC1  levels < 1.7 receiving FOLFOX, PFS and response rate were statistically superior to IT, with no significant difference in OS.
CONCLUSION


The evaluation of  ERCC1  in patients with upper GI tumors was thwarted by an overwhelming predominance of low  ERCC1  mRNA expression. Nonetheless, distribution of treatment effects on PFS did not vary with expression. For all patients and for those with low  ERCC1  expression, FOLFOX was superior in efficacy to IT.",2020,"< 1.7 receiving FOLFOX, PFS and response rate were statistically superior to IT, with no significant difference in OS.
","['patients with AEGC', 'patients who have HER2-negative, advanced esophagogastric cancer (AEGC', 'patients with  ERCC1  levels', 'patients with upper GI tumors', 'Overall, 202 untreated patients with HER2-negative AEGC and a Zubrod performance status of 0-1 were evaluated prospectively for mRNA expression of  ERCC1  level and then randomly assigned to FOLFOX or IT, stratified by the intratumoral statuses of  ERCC1  low (< 1.7) or high (≥ 1.7']","['FOLFOX', 'Platinum-based therapy', 'platinum-based therapy with fluorouracil, leucovorin, and oxaliplatin (FOLFOX) versus a non-platinum-containing regimen of irinotecan and docetaxel (IT']","['PFS and response rate', 'progression-free survival (PFS) and overall survival (OS', 'OS', '3 neuropathy and decreased neutrophils', 'Occurrences of grade ≥', 'Grade ≥ 3 anemia, dehydration, diarrhea, and fatigue', 'superior median PFS', 'Metastatic Esophageal, Gastric, or Gastroesophageal Cancer by Gene Expression of']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C1112160', 'cui_str': 'Gastrooesophageal cancer'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}]",202.0,0.0416042,"< 1.7 receiving FOLFOX, PFS and response rate were statistically superior to IT, with no significant difference in OS.
","[{'ForeName': 'Syma', 'Initials': 'S', 'LastName': 'Iqbal', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'McDonough', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ilson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burtness', 'Affiliation': 'Yale University School of Medicine and Yale Cancer Center, New Haven, CT.'}, {'ForeName': 'Chaitali S', 'Initials': 'CS', 'LastName': 'Nangia', 'Affiliation': 'University of California Irvine, Orange, CA.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Barzi', 'Affiliation': 'University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Schneider', 'Affiliation': 'University of Pennsylvania, Newark, DE.'}, {'ForeName': 'Jane Jijun', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'Illinois Cancer Care, Peoria, IL.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Dotan', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, PA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Howard S', 'Initials': 'HS', 'LastName': 'Hochster', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, NJ.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00925']
447,31529194,Prophylactic negative wound therapy in laparotomy wounds (PROPEL trial): randomized controlled trial.,"BACKGROUND


Superficial surgical site infections are a common post-operative complication. They also place a considerable financial burden on healthcare. The use of prophylactic negative pressure wound therapy has been advocated to reduce wound infection rates. However, there is debate around its routine use. The purpose of this trial is to determine if prophylactic negative pressure wound therapy reduces post-operative wound complications in patients undergoing laparotomy.
METHODS/DESIGN


This multi-centre randomised controlled trial will compare standard surgical dressings (control) to two competing negative pressure wound therapy dressings (Prevena™ and PICO™). All patients will be over 18 years, who are undergoing an emergency or elective laparotomy. It is intended to enrol a total of 271 patients for the trial.
DISCUSSION


The PROPEL trial is a multi-centre randomised controlled trial of patients undergoing laparotomy. The comparison of standard treatment to two commercially available NPWT will help provide consensus on the routine management of laparotomy wounds.
TRIAL REGISTRATION


This study is registered with ClinicalTrials.gov (NCT number NCT03871023).",2019,This multi-centre randomised controlled trial will compare standard surgical dressings (control) to two competing negative pressure wound therapy dressings (Prevena™ and PICO™).,"['271 patients for the trial', 'patients undergoing laparotomy', 'All patients will be over 18\xa0years, who are undergoing an emergency or elective laparotomy']","['prophylactic negative pressure wound therapy', 'Prophylactic negative wound therapy', 'standard surgical dressings (control) to two competing negative pressure wound therapy dressings (Prevena™ and PICO™']",['wound infection rates'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3653515', 'cui_str': 'SURGICAL DRESSINGS'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}]","[{'cui': 'C0043241', 'cui_str': 'Wound Infection'}]",271.0,0.265031,This multi-centre randomised controlled trial will compare standard surgical dressings (control) to two competing negative pressure wound therapy dressings (Prevena™ and PICO™).,"[{'ForeName': 'Noel Edward', 'Initials': 'NE', 'LastName': 'Donlon', 'Affiliation': 'Department of Surgery, St James Hospital, Dublin 8, Ireland. donlonn@tcd.ie.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Boland', 'Affiliation': 'Department of Surgery, St James Hospital, Dublin 8, Ireland.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Kelly', 'Affiliation': 'Department of Surgery, St James Hospital, Dublin 8, Ireland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Schmidt', 'Affiliation': 'Department of Surgery, Wexford General Hospital, Wexford, Ireland.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Cooke', 'Affiliation': 'Department of Surgery, University Hospital Waterford, Waterford, Ireland.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Neary', 'Affiliation': 'Department of Surgery, University Hospital Waterford, Waterford, Ireland.'}, {'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Barry', 'Affiliation': 'Department of Surgery, Mayo University Hospital, Mayo, Ireland.'}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Reynolds', 'Affiliation': 'Department of Surgery, St James Hospital, Dublin 8, Ireland.'}]",International journal of colorectal disease,['10.1007/s00384-019-03398-9']
448,32028504,Maternal Sense of Control During Childbirth and Infant Feeding Method.,"OBJECTIVE


To estimate whether maternal sense of control in labor is associated with breastfeeding at 4-8 weeks postpartum.
METHODS


This is a secondary analysis of data from a multicenter randomized controlled trial of elective induction of labor at 39 weeks of gestation in low-risk nulliparous women. In this trial, women completed the Labor Agentry Scale, a validated measure of women's feelings of control over the childbirth process, 6-96 hours after delivery. The Labor Agentry Scale score, which is higher with more perceived control during childbirth, was analyzed both as a continuous and a categorical variable (quintiles). Self-reported breastfeeding at 4-8 weeks postpartum was categorized as exclusive breastfeeding, breastfeeding and formula feeding, or exclusive formula feeding. Women were included in this analysis if they labored, filled out a Labor Agentry Scale questionnaire, had a neonate who survived until the postpartum visit, and provided information on infant feeding. Multinomial logistic regression was used to adjust for confounders.
RESULTS


Of 5,185 women, 32.9% (n=1,705) were exclusively breastfeeding, 31.2% (n=1,620) were breastfeeding and formula feeding, and 35.9% (n=1,860) were exclusively formula feeding 4-8 weeks after delivery. Overall Labor Agentry Scale score ranged from 34 to 203 (median 167, interquartile range 145-182). The median Labor Agentry Scale score was 169 (interquartile range 151-183) for women exclusively breastfeeding, 166 (interquartile range 142-182) for women who were breastfeeding and formula feeding, and 164 (interquartile range 142-181) for women who were only formula feeding (P<.001). In the unadjusted multinomial model, women with Labor Agentry Scale scores in the lowest two quintiles (ie, those with lower perceived control during childbirth) were less likely to be exclusively breastfeeding (as compared with those exclusively formula feeding) than women in the highest Labor Agentry Scale quintile. When controlling for confounders, however, this association was no longer significant.
CONCLUSION


After adjustment for confounders, perceived control during childbirth was not associated with breastfeeding at 4-8 weeks postpartum among nulliparous women.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT01990612.",2020,"Overall Labor Agentry Scale score ranged from 34 to 203 (median 167, interquartile range 145-182).","['low-risk nulliparous women', 'Of 5,185 women, 32.9% (n=1,705) were exclusively breastfeeding, 31.2% (n=1,620) were breastfeeding and formula feeding, and 35.9% (n=1,860', 'Women were included in this analysis if they labored, filled out a Labor Agentry Scale questionnaire, had a neonate who survived until the postpartum visit, and provided information on infant feeding']",['elective induction of labor'],"['Labor Agentry Scale scores', 'Overall Labor Agentry Scale score', 'Maternal Sense of Control', 'median Labor Agentry Scale score', 'Labor Agentry Scale score']","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C1720302', 'cui_str': 'Until'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0259787', 'cui_str': 'Labor Induction'}]","[{'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021783', 'cui_str': 'Sense of Control'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",5185.0,0.114384,"Overall Labor Agentry Scale score ranged from 34 to 203 (median 167, interquartile range 145-182).","[{'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Dude', 'Affiliation': ""Departments of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois; George Washington University Biostatistics Center, Washington, DC; Department of Obstetrics and Gynecology, Yale University, New Haven, Connecticut; University of Alabama at Birmingham, Birmingham, Alabama; University of Utah Health Sciences Center, Salt Lake City, Utah; Stanford University, Stanford, California; Columbia University, New York, New York; Brown University, Providence, Rhode Island; University of Texas Medical Branch, Galveston, Texas; University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas; The Ohio State University, Columbus, Ohio; MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio; University of Texas Southwestern Medical Center, Dallas, Texas; University of Pennsylvania, Philadelphia, Pennsylvania; Duke University, Durham, North Carolina; and the University of Pittsburgh, Pittsburgh, Pennsylvania; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.""}, {'ForeName': 'Lida M', 'Initials': 'LM', 'LastName': 'Fette', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Alan T N', 'Initials': 'ATN', 'LastName': 'Tita', 'Affiliation': ''}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': ''}, {'ForeName': 'Yasser Y', 'Initials': 'YY', 'LastName': 'El-Sayed', 'Affiliation': ''}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Wapner', 'Affiliation': ''}, {'ForeName': 'Dwight J', 'Initials': 'DJ', 'LastName': 'Rouse', 'Affiliation': ''}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Saade', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Thorp', 'Affiliation': ''}, {'ForeName': 'Suneet P', 'Initials': 'SP', 'LastName': 'Chauhan', 'Affiliation': ''}, {'ForeName': 'Jay D', 'Initials': 'JD', 'LastName': 'Iams', 'Affiliation': ''}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Chien', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': ''}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': ''}, {'ForeName': 'Hyagriv N', 'Initials': 'HN', 'LastName': 'Simhan', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003697']
449,32212354,Impact on Health-Related Quality of Life of Parenteral Nutrition for Patients with Advanced Cancer Cachexia: Results from a Randomized Controlled Trial.,"BACKGROUND


Malnutrition worsens health-related quality of life (HRQoL) and the prognosis of patients with advanced cancer. This study aimed to assess the clinical benefits of parenteral nutrition (PN) over oral feeding (OF) for patients with advanced cancer cachexia and without intestinal impairment.
MATERIAL AND METHODS


In this prospective multicentric randomized controlled study, patients with advanced cancer and malnutrition were randomly assigned to optimized nutritional care with or without supplemental PN. Zelen's method was used for randomization to facilitate inclusions. Nutritional and performance status and HRQoL using the European Organization for Research and Treatment of Cancer QLQ-C15-PAL questionnaire were evaluated at baseline and monthly until death. Primary endpoint was HRQoL deterioration-free survival (DFS) defined as a definitive deterioration of ≥10 points compared with baseline, or death.
RESULTS


Among the 148 randomized patients, 48 patients were in the experimental arm with PN, 63 patients were in the control arm with OF only, and 37 patients were not included because of early withdrawal or refused consent. In an intent to treat analysis, there was no difference in HRQoL DFS between the PN arm or OF arm for the three targeted dimensions: global health (hazard ratio [HR], 1.31; 95% confidence interval [CI], 0.88-1.94; p = .18), physical functioning (HR, 1.58; 95% CI, 1.06-2.35; p = .024), and fatigue (HR, 1.19; 95% CI, 0.80-1.77; p = .40); there was a negative trend for overall survival among patients in the PN arm. In as treated analysis, serious adverse events (mainly infectious) were more frequent in the PN arm than in the OF arm (p = .01).
CONCLUSION


PN improved neither HRQoL nor survival and induced more serious adverse events than OF among patients with advanced cancer and malnutrition. Clinical trial identification number. NCT02151214 IMPLICATIONS FOR PRACTICE: This clinical trial showed that parenteral nutrition improved neither quality of life nor survival and generated more serious adverse events than oral feeding only among patients with advanced cancer cachexia and no intestinal impairment. Parenteral nutrition should not be prescribed for patients with advanced cancer, cachexia, and no intestinal failure when life expectancy is shorter than 3 months. Further studies are needed to assess the useful period with a potential benefit of artificial nutrition for patients with advanced cancer.",2020,"In an intent to treat analysis, there was no difference in HRQoL DFS between the PN arm or OF arm for the three targeted dimensions: global health (hazard ratio [HR], 1.31; 95% confidence interval [CI], 0.88-1.94; p = .18), physical functioning (HR, 1.58; 95% CI, 1.06-2.35; p = .024), and fatigue (HR, 1.19; 95% CI, 0.80-1.77; p = .40); there was a negative trend for overall survival among patients in the PN arm.","['patients with advanced cancer and malnutrition', '148 randomized patients, 48 patients were in the experimental arm with PN, 63 patients were in the control arm with OF only, and 37 patients were not included because of early withdrawal or refused consent', 'patients with advanced cancer cachexia and no intestinal impairment', 'patients with advanced cancer', 'patients with advanced cancer cachexia and without intestinal impairment', 'Patients with Advanced Cancer Cachexia']","['Parenteral Nutrition', 'Parenteral nutrition', 'parenteral nutrition (PN) over oral feeding (OF', 'optimized nutritional care with or without supplemental PN', 'parenteral nutrition']","['physical functioning', 'overall survival', 'HRQoL nor survival', 'serious adverse events', 'HRQoL deterioration-free survival (DFS) defined as a definitive deterioration of ≥10 points compared with baseline, or death', 'HRQoL DFS', 'Cancer QLQ-C15-PAL questionnaire', 'quality of life nor survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]","[{'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0034380'}]",148.0,0.277114,"In an intent to treat analysis, there was no difference in HRQoL DFS between the PN arm or OF arm for the three targeted dimensions: global health (hazard ratio [HR], 1.31; 95% confidence interval [CI], 0.88-1.94; p = .18), physical functioning (HR, 1.58; 95% CI, 1.06-2.35; p = .024), and fatigue (HR, 1.19; 95% CI, 0.80-1.77; p = .40); there was a negative trend for overall survival among patients in the PN arm.","[{'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Bouleuc', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) Besançon, France.""}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Anota', 'Affiliation': 'Methodology and Quality of Life in Oncology Unit (INSERM Unité Mixte de Recherche [UMR] 1098), Centre Hospitalier Universitaire (CHU) Besançon, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Cornet', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) Besançon, France.""}, {'ForeName': 'Ghislain', 'Initials': 'G', 'LastName': 'Grodard', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) Besançon, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Thiery-Vuillemin', 'Affiliation': 'Medical Oncology Department, Centre Hospitalier Universitaire (CHU) Besançon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Dubroeucq', 'Affiliation': 'Department of Supportive Care, Institut Jean Godinot, Reims, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Crétineau', 'Affiliation': 'Department of Supportive Care, Institut de cancérologie de Lorraine, Vandoeuvre-lès-Nancy, France.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Frasie', 'Affiliation': 'Department of Supportive Care, Centre Paul Strauss, Strasbourg, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gamblin', 'Affiliation': 'Department of Supportive Care, Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Gisèle', 'Initials': 'G', 'LastName': 'Chvetzoff', 'Affiliation': 'Department of Supportive Care, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Favier', 'Affiliation': 'Medical Oncology Department, Centre Georges-François Leclerc, Dijon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tournigand', 'Affiliation': 'Medical Oncology Department, Hôpital Henri Mondor, Assistance Publique-Hôpitaux de Paris (APHP), Créteil, France.'}, {'ForeName': 'Marie-Christine', 'Initials': 'MC', 'LastName': 'Grach', 'Affiliation': 'Department of Supportive Care, Centre François-Baclesse, Caen, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Raynard', 'Affiliation': 'Tranversal Unit of Nutrition, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Salas', 'Affiliation': 'Medical Oncology Department, Centre Hospitalier (CH) La Timone, Marseille, France.'}, {'ForeName': 'Géraldine', 'Initials': 'G', 'LastName': 'Capodano', 'Affiliation': 'Department of Supportive Care, Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Pazart', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) Besançon, France.""}, {'ForeName': 'Régis', 'Initials': 'R', 'LastName': 'Aubry', 'Affiliation': ""INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) Besançon, France.""}]",The oncologist,['10.1634/theoncologist.2019-0856']
450,32272037,Re: Bladder Preservation with Twice-a-Day Radiation plus Fluorouracil/Cisplatin or Once Daily Radiation plus Gemcitabine for Muscle-Invasive Bladder Cancer: NRG/RTOG 0712-A Randomized Phase II Trial.,,2020,,['Muscle-Invasive Bladder Cancer'],['Re: Bladder Preservation with Twice-a-Day Radiation plus Fluorouracil/Cisplatin or Once Daily Radiation plus Gemcitabine'],[],"[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}]",[],,0.0405648,,"[{'ForeName': 'Sam S', 'Initials': 'SS', 'LastName': 'Chang', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001055']
451,32272079,Correction to Lancet Infect Dis 2020; published online March 30. https://doi.org/10.1016/S1473-3099(20)30257-7.,,2020,,[],[],[],[],[],[],,0.0200868,,[],The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30283-8']
452,32179792,Myocardial Minimal Damage After Rapid Ventricular Pacing - the prospective randomized multicentre MyDate-Trial.,"Therapy of choice for the primary and secondary prevention of sudden cardiac death is the implantation of an implantable cardioverter defibrillator (ICD). Whereas appropriate and inappropriate ICD shocks lead to myocardial microdamage, this is not known for antitachycardia pacing (ATP). In total, 150 ICD recipients (66 ± 12 years, 81.3% male, 93.3% primary prevention, 30.0% resynchronization therapy) were randomly assigned to an ICD implantation with or without intraoperative ATP. In the group with ATP, the pacing maneuver was performed twice, each time applying 8 impulses à 6 Volt x 1.0 milliseconds to the myocardium. High sensitive Troponin T (hsTnT) levels were determined prior to the implantation and thereafter. There was no significant difference in the release of hsTnT between the two randomization groups (delta TnT without ATP in median 0.010 ng/ml [min. -0.016 ng/ml-max. 0.075 ng/ml] vs. with ATP in median 0.013 ng/ml [min. -0.005-0.287 ng/ml], p = 0.323). Setting a hsTnT cutoff of 0.059 ng/dl as a regularly augmented postoperative hsTnT level, no relevant difference between the two groups regarding the postoperative hsTnT levels above this cutoff could be identified (without ATP n = 10 [14.7%] vs. with ATP n = 16 [21.9%], p = 0.287). There was no significant difference in the release of high sensitive Troponin between patients without intraoperative ATP compared to those with intraoperative ATP. Hence, antitachycardia pacing does not seem to cause significant myocardial microdamage. This may further support its use as a painless and efficient method to terminate ventricular tachycardia in high-risk patients.",2020,There was no significant difference in the release of high sensitive Troponin between patients without intraoperative ATP compared to those with intraoperative ATP.,"['150 ICD recipients (66\u2009±\u200912 years, 81.3% male, 93.3% primary prevention, 30.0% resynchronization therapy']","['ICD implantation with or without intraoperative ATP', 'implantable cardioverter defibrillator (ICD']","['release of high sensitive Troponin', 'sudden cardiac death', 'Myocardial Minimal Damage', 'High sensitive Troponin T (hsTnT) levels', 'release of hsTnT', 'postoperative hsTnT levels']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0033144', 'cui_str': 'Disease Prevention, Primary'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0523952', 'cui_str': 'Troponin measurement'}, {'cui': 'C0085298', 'cui_str': 'Sudden Cardiac Death'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",150.0,0.0434339,There was no significant difference in the release of high sensitive Troponin between patients without intraoperative ATP compared to those with intraoperative ATP.,"[{'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Semmler', 'Affiliation': 'Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Abteilung Elektrophysiologie, Technische Universität München, Munich, Germany. semmler@dhm.mhn.de.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Deutschmann', 'Affiliation': 'Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Abteilung Elektrophysiologie, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Haller', 'Affiliation': 'Klinikum rechts der Isar, Institut für Medizinische Informatik, Statistik und Epidemiologie, Fakultät für Medizin, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Lennerz', 'Affiliation': 'Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Abteilung Elektrophysiologie, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Brkic', 'Affiliation': 'Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Abteilung Elektrophysiologie, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grebmer', 'Affiliation': 'Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Abteilung Elektrophysiologie, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Blazek', 'Affiliation': 'Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Abteilung Elektrophysiologie, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Weigand', 'Affiliation': 'Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Abteilung Elektrophysiologie, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Karch', 'Affiliation': 'Herz- und Gefäßzentrum Oberallgäu-Kempten, Klinikum Kempten, Kempten, Germany.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Busch', 'Affiliation': 'Klinikum Coburg, Abteilung für Kardiologie und Angiologie, Coburg, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Kolb', 'Affiliation': 'Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen, Abteilung Elektrophysiologie, Technische Universität München, Munich, Germany.'}]",Scientific reports,['10.1038/s41598-020-61625-8']
453,30676218,"The Effects of a Divided-Attention Timed Stepping Accuracy Task on Balance, Strength, Endurance, and Functional Performance in Healthy Older Adults: A Pilot Study.","The aim of this study was to investigate whether a 6-week Divided-Attention Stepping Accuracy Task (DATSAT) intervention improved the primary outcome measure, maximal step length; other balance measures (Berg Balance scale and Timed Up and Go test); leg strength; endurance (6-min walk test); and functional tasks in 15 community-dwelling healthy older adults (  x ¯  age: 71.5 years, female: 46.7%) compared with 15 community-dwelling healthy older adults in a Bike and Strength (B&S) program (  x ¯  age: 73.8 years, female: 33.3%). Participants trained 3× per week, 30-60 min per session. Stepping-group differences were significant for all measures. B&S group improved in maximal step length (anterior and lateral), strength, and one functional task. Stepping group outperformed B&S group in Timed Up and Go and maximal step length posterior. B&S group outperformed stepping group in two strength measures. Exertion scores were lower for the stepping group. Overall, Divided-Attention Timed Stepping Accuracy Task training resulted in more within-group improvements and two between-group measures with less perceived effort and shorter intervention times.",2019,Exertion scores were lower for the stepping group.,"['Healthy Older Adults', 'age: 73.8 years, female: 33.3', '15 community-dwelling healthy older adults (  x ¯  age: 71.5 years, female: 46.7%) compared with 15 community-dwelling healthy older adults in a Bike and Strength (B&S) program ']","['Divided-Attention Timed Stepping Accuracy Task', 'Divided-Attention Stepping Accuracy Task (DATSAT) intervention']","['Balance, Strength, Endurance, and Functional Performance', 'Exertion scores', 'balance measures (Berg Balance scale and Timed Up and Go test); leg strength; endurance (6-min walk test); and functional tasks', 'maximal step length (anterior and lateral), strength, and one functional task']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517716', 'cui_str': 'Thirty-three point three'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1261552', 'cui_str': 'Step'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C3853978'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0427126', 'cui_str': 'Step length (observable entity)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}]",,0.0146599,Exertion scores were lower for the stepping group.,"[{'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Leach', 'Affiliation': ''}, {'ForeName': 'Joyce R', 'Initials': 'JR', 'LastName': 'Maring', 'Affiliation': ''}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Costello', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2018-0010']
454,32057976,Efficacy of Single-Operator Cholangioscopy-Guided Lithotripsy Compared With Large Balloon Sphincteroplasty in Management of Difficult Bile Duct Stones in a Randomized Trial.,"BACKGROUND & AIMS


Although single-operator cholangioscopy (SOC)-guided lithotripsy and large balloon sphincteroplasty (LBS)-based techniques are effective rescue measures, the ideal approach to management of difficult bile duct stones is unclear. We conducted a randomized trial to compare the effectiveness of SOC-guided lithotripsy and LBS-based approaches for endoscopic management of difficult bile duct stones.
METHODS


Patients with difficult bile duct stones who failed retrieval using balloon or basket were randomly assigned to groups that received SOC-guided laser lithotripsy (SOC-LL, n = 33) or LBS (n = 33), from June 2016 through August 2018. When assigned treatment was unsuccessful, patients underwent mechanical lithotripsy before crossing over to the other group. The main outcome was treatment success, defined as ability to clear the duct in 1 session. Secondary outcomes were adverse events and treatment costs.
RESULTS


A higher proportion of patients in the SOC-LL group had treatment success (93.9%) than in the LBS group (72.7%; P = .021). On multiple logistic regression analysis, treatment success was significantly associated with use of SOC-LL (odds ratio [OR], 8.7; 95% CI, 1.3-59.3; P = .026), stone to extrahepatic bile duct ratio of 1 or less (OR, 28.8; 95% CI, 1.2-687.6; P = .038), and lack of a tapered bile duct (OR, 26.9; 95% CI, 1.3-558.2; P = .034). There was no significant difference between groups in adverse events (9.1% in the SOC-LL group vs 3.0% in the LBS group, P = .61) or overall treatment cost ($16,684 in the SOC-LL group vs $10,626 in the LBS group; P = .097).
CONCLUSIONS


In a randomized trial of patients with difficult bile stones that cannot be cleared by standard maneuvers, SOC-guided lithotripsy leads to duct clearance in a significantly higher proportion of patients than LBS-particularly when stone size exceeds the diameter of the extrahepatic bile duct. Adjunct lithotripsy might be required in patients with tapered distal bile duct, because LBS alone is less likely to be successful. ClinicalTrials.gov no: NCT00852072.",2020,"There was no significant difference between groups in adverse events (9.1% in the SOC-LL group vs 3.0% in the LBS group, P=.61) or overall treatment cost ($16,684 in the SOC-LL group vs $10,626 in the LBS group; P=.097).
","['patients with difficult bile stones', 'Patients with difficult bile duct stones who failed retrieval using balloon or basket', 'n=33), from June 2016 through August 2018', 'patients with tapered distal bile duct']","['single-operator cholangioscopy (SOC)-guided lithotripsy and large balloon sphincteroplasty (LBS)-based techniques', 'Single-Operator Cholangioscopy-guided Lithotripsy Compared With Large Balloon Sphincteroplasty', 'SOC-guided lithotripsy and LBS-based approaches', 'mechanical lithotripsy', 'SOC-guided laser lithotripsy (SOC-LL, n=33) or LBS', 'Adjunct lithotripsy']","['treatment success', 'overall treatment cost', 'stone to extrahepatic bile duct ratio', 'adverse events', 'adverse events and treatment costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0005388', 'cui_str': 'Bile'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0267869', 'cui_str': 'Calculus of bile duct (disorder)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0005400', 'cui_str': 'Bile Ducts'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0940834', 'cui_str': 'Cholangioscopy (procedure)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0206099', 'cui_str': 'Lithotripsy, Laser'}, {'cui': 'C0042950', 'cui_str': 'Will'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0206187', 'cui_str': 'Extrahepatic Biliary System'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.122076,"There was no significant difference between groups in adverse events (9.1% in the SOC-LL group vs 3.0% in the LBS group, P=.61) or overall treatment cost ($16,684 in the SOC-LL group vs $10,626 in the LBS group; P=.097).
","[{'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Bang', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, Florida.'}, {'ForeName': 'Bryce', 'Initials': 'B', 'LastName': 'Sutton', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, Florida.'}, {'ForeName': 'Udayakumar', 'Initials': 'U', 'LastName': 'Navaneethan', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, Florida.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hawes', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, Florida.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Varadarajulu', 'Affiliation': 'Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, Florida. Electronic address: svaradarajulu@yahoo.com.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.02.003']
455,31818055,Effects of visual training in tennis performance in male junior tennis players: a randomized controlled trial.,"BACKGROUND


Tennis is an open-skill dynamic sport in which players over a limited period of time have to process and integrate complex visual information. Therefore, the aim of this study was to assess the effects of 12 weeks visual training (VT) in junior tennis players.
METHODS


This was a two-arm parallel-group randomized-controlled trial in which 20 male junior players were randomized to either an experimental group (EG: N.=10; age: 15±1 year; height: 1.67±0.01 m; body mass: 52±11 kg) that performed VT or a control group (CG: N.=10; age: 15±1 year; height: 1.70±0.01 m; body mass: 52±12 kg) that was involved in a standard training for 3 sessions a week for 12 weeks. Players were tested at baseline (T0) and after 12 weeks of training (T12) for evaluate sweet spot, speed and time course between split steep and shoulder rotation during forehand, backhand, 1st and 2nd serve and return to serve.
RESULTS


At T12 two-way Anova with Tuckey multiple comparison test showed significant improvements in sweet spot (P=0.032; ES: 2.1±0.3, most likely) and speed (P=0.002; ES: 1.8±0.4, very likely) during second serve were found. Moreover, the time course between the split step and shoulder rotation in forehand (P=0.0008; ES: ≥2.0±0.3, most likely), backhand (P=0.001; ES: ≥2.0±0.5, most likely), and return to serve (P=0.001; ES: 1.7±0.2, very likely) improved significantly.
CONCLUSIONS


These results suggest that VT was effective to improve on-court tennis performance in junior tennis players.",2020,"Moreover, the time course between the split step and shoulder rotation in forehand (P=0.0008; ES: ≥2.0±0.3, most likely), backhand (P=0.001; ES: ≥2.0±0.5, most likely), and return to serve (P=0.001; ES: 1.7±0.2, very likely) improved significantly.
","['20 male junior players', 'male junior tennis players', 'junior tennis players']","['visual training', 'VT', 'visual training (VT']","['time course between the split step and shoulder rotation', 'effective to improve on-court tennis performance', 'sweet spot']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}]","[{'cui': 'C0200244', 'cui_str': 'Visual training'}]","[{'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}]",20.0,0.0711885,"Moreover, the time course between the split step and shoulder rotation in forehand (P=0.0008; ES: ≥2.0±0.3, most likely), backhand (P=0.001; ES: ≥2.0±0.5, most likely), and return to serve (P=0.001; ES: 1.7±0.2, very likely) improved significantly.
","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bonato', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy - matteo.bonato@grupposandonato.it.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Gatti', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Rossi', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Giampiero', 'Initials': 'G', 'LastName': 'Merati', 'Affiliation': 'Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'La Torre', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.19.10218-6']
456,31818058,The effect of music on anaerobic exercise performance and muscular endurance.,"BACKGROUND


Music has been shown to improve aerobic and anaerobic exercise performance; however, music's effect on resistance training exercise, gender differences, and heart rate (HR) is less understood. The purpose of this study was to examine the effects of self-selected music on anaerobic exercise performance using a bench press (BP) protocol and the Wingate anaerobic test (WAT).
METHODS


Fifteen (8 men; 7 women) healthy, college-aged students between 18-25 years old (20.1±1.79 yrs) participated in this study. Testing consisted of two trials (music [M]; no music [NM]] completed in a randomized order. Each participant performed the BP for a maximum number of repetitions using 70% one-repetition maximum for five sets. After a 10 min rest period, a 30 s Wingate anaerobic Test (WAT) was completed.
RESULTS


During the M condition, there was a significant increase in total work (M: 16121.8±4287.3 kJ; NM: 15021.7±4370.6 kJ; P=0.024), relative peak power (M: 44.6±8.4 W; NM: 41.4±8.4 W; P=0.014), and the total number of bench press repetitions (M: 41.7±8.7 reps; NM: 38.3±8.1 reps; P=0.001). HR recovery following the WAT protocol was significantly quicker after the WAT protocol during the M condition (M: 256.2±54.5 sec.; NM 293.3±22.3 sec.; P=0.022). There was no significant condition as for gender interaction for any of the variables assessed.
CONCLUSIONS


Listening to self-selected music improved exercise performance during the BP and the WAT. Music also hastened HR recovery following the WAT.",2020,"During the M condition, there was a significant increase in total work (M: 16121.8±4287.3 kJ; NM: 15021.7±4370.6 kJ; P=0.024), relative peak power (M: 44.6±8.4 W; NM: 41.4±8.4 W; P=0.014), and the total number of bench press repetitions (M: 41.7±8.7 reps; NM: 38.3±8.1 reps; P=0.001).","['Fifteen (8 men; 7 women) healthy, college-aged students between 18-25 years old (20.1±1.79 yrs) participated in this study']","['self-selected music', 'two trials (music [M]; no music [NM']","['anaerobic exercise performance and muscular endurance', 'Wingate anaerobic Test (WAT', 'total work', 'anaerobic exercise performance', 'HR recovery', 'exercise performance', 'heart rate (HR', 'total number of bench press repetitions']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0454326', 'cui_str': 'Bench press (regime/therapy)'}]",,0.183629,"During the M condition, there was a significant increase in total work (M: 16121.8±4287.3 kJ; NM: 15021.7±4370.6 kJ; P=0.024), relative peak power (M: 44.6±8.4 W; NM: 41.4±8.4 W; P=0.014), and the total number of bench press repetitions (M: 41.7±8.7 reps; NM: 38.3±8.1 reps; P=0.001).","[{'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Cutrufello', 'Affiliation': 'Department of Exercise Science and Sport, The University of Scranton, Scranton, PA, USA - paul.cutrufello@scranton.edu.'}, {'ForeName': 'Brittany A', 'Initials': 'BA', 'LastName': 'Benson', 'Affiliation': 'Department of Physical Therapy, Nova Southeastern University, Fort Lauderdale, FL, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Landram', 'Affiliation': 'Department of Exercise Science and Sport, The University of Scranton, Scranton, PA, USA.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.19.10228-9']
457,31701308,Comparison of single minimum dose administration of dexmedetomidine and midazolam for prevention of emergence delirium in children: a randomized controlled trial.,"PURPOSE


Emergence delirium (ED) is common in children after sevoflurane anesthesia and should be prevented for patient safety. A prospective, double-blind, randomized, controlled study was performed to compare the efficacy of minimal dosage of midazolam versus dexmedetomidine to prevent ED in children undergoing tonsillectomy.
METHODS


Seventy children aged 24 months to 12 years were allocated to receive midazolam (0.03 mg/kg) or dexmedetomidine (0.3 µg/kg) 5 min before the end of surgery. The incidence and severity of ED were assessed using a four-point scale and the pediatric anesthesia emergence delirium scale, respectively. The emergence time and postoperative pain scores were also evaluated.
RESULTS


The incidence of ED was 31.3% in the midazolam group and 26.5% in the dexmedetomidine group (P = 0.668). The severity of ED was similar in both groups (9.6 ± 5.8 in the midazolam group, vs. 8.1 ± 5.9 in the dexmedetomidine group, P = 0.299). The emergence time was comparable in the two groups [11.0 (8.3-13.8) min in midazolam group vs. 12.0 (10.0-13.5) min in dexmedetomidine group (P = 0.218)]. Postoperative pain score was higher in the midazolam group [0 (0-1)] than in the dexmedetomidine group [0 (0-0)] (P = 0.011).
CONCLUSION


Dexmedetomidine and midazolam at single minimum dosages had equal effectiveness to prevent ED in children without delaying emergence time, when administered at the end of surgery. With regards to postoperative analgesic efficacy, although dexmedetomidine showed statistically significant higher analgesic effect than midazolam, further clinical investigations are needed to validate our findings.",2020,"With regards to postoperative analgesic efficacy, although dexmedetomidine showed statistically significant higher analgesic effect than midazolam, further clinical investigations are needed to validate our findings.","['children', 'children undergoing tonsillectomy', 'Seventy children aged 24\xa0months to 12\xa0years', 'children after']","['dexmedetomidine', 'midazolam', 'Dexmedetomidine and midazolam', 'sevoflurane anesthesia', 'dexmedetomidine and midazolam']","['emergence time and postoperative pain scores', 'severity of ED', 'Postoperative pain score', 'incidence and severity of ED', 'incidence of ED', 'analgesic effect', 'emergence time', 'postoperative analgesic efficacy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}]",70.0,0.26482,"With regards to postoperative analgesic efficacy, although dexmedetomidine showed statistically significant higher analgesic effect than midazolam, further clinical investigations are needed to validate our findings.","[{'ForeName': 'Eun-Ah', 'Initials': 'EA', 'LastName': 'Cho', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.'}, {'ForeName': 'Yun-Byeong', 'Initials': 'YB', 'LastName': 'Cha', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.'}, {'ForeName': 'Jae-Geum', 'Initials': 'JG', 'LastName': 'Shim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.'}, {'ForeName': 'Jin-Hee', 'Initials': 'JH', 'LastName': 'Ahn', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.'}, {'ForeName': 'Sung Hyun', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea.'}, {'ForeName': 'Kyoung-Ho', 'Initials': 'KH', 'LastName': 'Ryu', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul, 03181, Republic of Korea. kh.ryu@skku.edu.'}]",Journal of anesthesia,['10.1007/s00540-019-02705-6']
458,32214294,Pulsed Radiofrequency of the Sacral Roots Improves the Success Rate of Superior Hypogastric Plexus Neurolysis in Controlling Pelvic and Perineal Cancer Pain.,"BACKGROUND


Superior hypogastric plexus neurolytic (SHP-N) block is the mainstay management for pelvic cancer pain of visceral origin when oral opioids fail due to inefficacy or intolerance to side effects. Unfortunately, SHP-N has the potential to control pelvic pain in 62%-72% of patients at best, because chronic pelvic pain may assume additional characteristics other than visceral.
OBJECTIVE


Combining SHP-N with pulsed radiofrequency (PRF) of the sacral roots might block most of the pain characteristics emanating from the pelvic structures and improve the success rate of SHP-N in controlling pelvic and perineal cancer pain.
STUDY DESIGN


This study was a prospective randomized controlled clinical trial.
SETTINGS


The research took place in the interventional pain unit of a tertiary center in the university hospital.
METHODS


Fifty-eight patients complaining of cancer-related chronic pelvic and perineal pain were randomized to either the PRF + SHP group (n = 29), which received SHP-N combined with PRF of the sacral roots S2-4, or the SHP group (n = 29), which received SHP-N alone. The outcome variables were the percentage of patients who showed a > 50% reduction in their Visual Analog Scale (VAS) pain score, the VAS pain score, and global perceived effect evaluated during a 3-month follow-up period.
RESULTS


The percentage of patients who showed a > 50% reduction in their VAS pain score was significantly higher in the SHP + PRF group compared to the SHP group when assessed at one month (92.9% [n = 26] vs 57.7% [n = 15]; P = .003) and 3 months (85.7% [n = 24) vs 53.8% [n = 14]; P = .01) post procedure, respectively. However, no significant difference was observed between the 2 groups at the 6-month evaluation (SHP + PRF [57.1% (n = 16)] vs SHP [50% (n = 13)]; P = .59). There was a statistically significant reduction of VAS in the SHP + PRF group in comparison to the SHP group at one month (2.8 ± 0.9 vs 3.5 ± 1.2 [mean difference, -0.7 (95% confidence interval [CI], -1.29 to -0.1), P = .01]), 2 months (2.8 ± 0.9 vs 3.5 ± 1.2 [mean difference, -0.64 (95% CI, -1.23 to -0.05), P = .03]), and 3 months (2.7 ± 1 vs 3.4 ± 1.2 [mean difference, -0.67 (95% CI, -1.29 to -0.05)], P = .03]) post procedure, respectively; however, the 2 groups did not significantly differ at 2 weeks, 4, 5, and 6 months post procedure. Regarding postprocedural analgesic consumption, there were trends towards reduced opioid consumption at all postprocedural measured time points in the SHP+PRF group compared to the SHP group; these differences reached statistical significance at 2 months (median, 30 [interquartile range (IQR), 0.00-30] vs median, 45 [IQR, 30-90]; P = .046) and 3 months (median, 0.00 [IQR, 0.00-30] vs median, 30 [IQR, 0.00-67.5]; P = .016) post procedure, respectively.
LIMITATIONS


The study follow-up period is limited to 6 months only.
CONCLUSIONS


SHP-N combined with PRF of the sacral roots (S2, 3, 4) provided a better analgesic effect than SHP-N alone for patients with chronic pelvic and perineal pain related to pelvic cancer.
TRIAL REGISTRY


ClinicalTrials.gov. NCT03228316.
KEY WORDS


Pelvic pain, pulsed radiofrequency, sacral roots, superior hypogastric plexus.",2020,"There was a statistically significant reduction of VAS in the SHP + PRF group in comparison to the SHP group at one month (2.8 ± 0.9 vs 3.5 ± 1.2 [mean difference, -0.7 (95% confidence interval [CI], -1.29 to -0.1), P = .01]), 2 months (2.8 ± 0.9 vs 3.5 ± 1.2 [mean difference, -0.64 (95% CI, -1.23 to -0.05), P = .03]), and 3 months (2.7 ± 1 vs 3.4 ± 1.2 [mean difference, -0.67 (95% CI, -1.29 to -0.05)], P = .03]) post procedure, respectively; however, the 2 groups did not significantly differ at 2 weeks, 4, 5, and 6 months post procedure.","['Fifty-eight patients complaining of cancer-related chronic pelvic and perineal pain', 'patients with chronic pelvic and perineal pain related to pelvic cancer']","['SHP-N with pulsed radiofrequency (PRF', 'Pulsed Radiofrequency of the Sacral Roots', 'SHP', 'SHP-N combined with PRF of the sacral roots S2-4, or the SHP', 'hypogastric plexus neurolytic (SHP-N) block', 'SHP-N alone', 'SHP + PRF', 'PRF + SHP']","['analgesic effect', 'Visual Analog Scale (VAS) pain score, the VAS pain score, and global perceived effect', 'VAS pain score', 'opioid consumption', 'VAS']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0478659', 'cui_str': 'Pelvic and perineal pain (finding)'}, {'cui': 'C0751416', 'cui_str': 'Cancer of Pelvis'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0020613', 'cui_str': 'Hypogastric Plexus'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0713119,"There was a statistically significant reduction of VAS in the SHP + PRF group in comparison to the SHP group at one month (2.8 ± 0.9 vs 3.5 ± 1.2 [mean difference, -0.7 (95% confidence interval [CI], -1.29 to -0.1), P = .01]), 2 months (2.8 ± 0.9 vs 3.5 ± 1.2 [mean difference, -0.64 (95% CI, -1.23 to -0.05), P = .03]), and 3 months (2.7 ± 1 vs 3.4 ± 1.2 [mean difference, -0.67 (95% CI, -1.29 to -0.05)], P = .03]) post procedure, respectively; however, the 2 groups did not significantly differ at 2 weeks, 4, 5, and 6 months post procedure.","[{'ForeName': 'Diab Fuad', 'Initials': 'DF', 'LastName': 'Hetta', 'Affiliation': 'South Egypt Cancer Institute, Assuit University, Egypt.'}, {'ForeName': 'Ashraf Amin', 'Initials': 'AA', 'LastName': 'Mohamed', 'Affiliation': ''}, {'ForeName': 'Rania Mohammed', 'Initials': 'RM', 'LastName': 'Abdel Eman', 'Affiliation': 'South Egypt Cancer Institute, Assuit University, Assuit City, Egypt.'}, {'ForeName': 'Fatma Ahmed', 'Initials': 'FA', 'LastName': 'Abd El Aal', 'Affiliation': 'Department of Anesthesia, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Marina Emeel', 'Initials': 'ME', 'LastName': 'Helal', 'Affiliation': 'South Egypt Cancer Institute, Assuit University, Assuit City, Egypt.'}]",Pain physician,[]
459,32214295,"Comparisons of Monopolar Lesion Volumes with Hypertonic Saline Solution in Radiofrequency Ablation: A Randomized, Double-Blind, Ex Vivo Study.","BACKGROUND


Chronic degeneration of the zygapophyseal joints in the cervical or lumbar spine are common causes of axial back pain. Radiofrequency (RF) ablation is a treatment modality in the denervation of facet joint-related pain. Although multiple factors have been theorized to contribute to the size of the optimal RF lesion, the addition of hypertonic saline solution has been posited to create larger RF lesion sizes.
OBJECTIVES


This study compares lesion of 20-gauge RF monopolar probe using 2% lidocaine, 0.9% normal saline solution, and 3% saline solution administered through the RF needle prior to ablation, with subsequent lesion sizes recorded.
STUDY DESIGN


Randomized, double-blinded, ex vivo study using clinically relevant conditions.
SETTING


Procedural laboratory in an academic institution.
METHODS


RF ablation lesions were reproduced in room temperature (21°C ± 2°C) chicken breast specimens with 20-gauge monopolar RF probes inserted. RF was applied for 90 seconds at 80°C after injection of 1 mL of either 2% lidocaine, 2% lidocaine and 0.9% normal saline solution in a 1:1 ratio, or 2% lidocaine and 3% saline solution in a 1:1 ratio. Tissues were dissected, measured, and ellipsoid volumes of burn calculated. Homogeneity of variances was assessed via the Bartlett's test, and heteroskedasticity with the studentized Breusch-Pagan test. One-way analysis of variance (ANOVA) (alpha of 0.05) was used to evaluate statistical significance between volume means across groups. When the null hypothesis of no difference in burn volume between samples could not be rejected, a predefined equivalence volume of ± 0.05 cm3 was used with Welch's 2 one-sided t-tests (TOST) with a Bonferroni adjusted alpha of 0.0167 to evaluate for null acceptance.
RESULTS


The mean lesion volume for monopolar RF with 1 mL 2% lidocaine was 0.16 cm3. Monopolar RF with 1 mL 2% lidocaine + 0.9% normal saline solution had a mean lesion volume of 0.15 cm3, and treatment with 1 mL 2% lidocaine + 3% saline solution measured 0.17 cm3. ANOVA failed to reject the null, and TOST accepted as equivalent all 3 comparisons.
LIMITATIONS


In vivo anatomy and physiology of a human organism was not used for this study. Samples were not warmed to physiologic temperature. Randomization resulted in slightly unequal sample sizes, although all groups were of sufficient size that the central limit theorem should apply.
CONCLUSIONS


Three commonly used solutions were found to have equivalent lesion sizes from monopolar probe RF ablation.
KEY WORDS


Radiofrequency, ablation, lesion shape, lesion size, monopolar RF, hypertonic saline solution.",2020,"Monopolar RF with 1 mL 2% lidocaine + 0.9% normal saline solution had a mean lesion volume of 0.15 cm3, and treatment with 1 mL 2% lidocaine + 3% saline solution measured 0.17 cm3.","['Radiofrequency Ablation', 'Procedural laboratory in an academic institution']","['lidocaine, 2% lidocaine and 0.9% normal saline solution', '20-gauge RF monopolar probe using 2% lidocaine, 0.9% normal saline solution, and 3% saline solution', 'Monopolar RF with 1 mL 2% lidocaine + 0.9% normal saline solution', 'Hypertonic Saline Solution', 'lidocaine and 3% saline solution', 'Radiofrequency (RF) ablation', 'lidocaine']",['mean lesion volume'],"[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0439166', 'cui_str': '% normal (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0456564', 'cui_str': 'Gauges (qualifier value)'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.447207,"Monopolar RF with 1 mL 2% lidocaine + 0.9% normal saline solution had a mean lesion volume of 0.15 cm3, and treatment with 1 mL 2% lidocaine + 3% saline solution measured 0.17 cm3.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Tolga', 'Initials': 'T', 'LastName': 'Suvar', 'Affiliation': 'Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Johnathan', 'Initials': 'J', 'LastName': 'Goree', 'Affiliation': 'Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sanford', 'Affiliation': 'Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Nivetha', 'Initials': 'N', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Heejung', 'Initials': 'H', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology, University of Arkansas for Medical Sciences, Little Rock, AR.'}]",Pain physician,[]
460,30386978,Communicating Actively Responding Empathically (CARE): Comparison of Communication Training Workshops for Health Professionals Working in Cancer Care.,"Accessing full-day communication skills training can be challenging for health professionals working in cancer care. This study aimed to examine the effectiveness of Communicating Actively, Responding Empathically (CARE Express), a modified 2-h communication skills training course, across measures of health professional confidence, skills and attitudes. Cancer care health professionals (n = 147) were recruited from allied health, nursing and medical disciplines, using a partial randomisation to allocate to three arms: control, two-hour training (CARE Express) and 1-day training (CARE). Perceived confidence and skills were measured by self-report using a purpose-built scale, and written responses to a challenging clinical encounter were obtained at baseline, post-training and three-months post-training. Attitudes toward psychosocial issues were evaluated with the Physician Belief Scale at baseline and 3 months post-training. No changes were observed in the control group (n = 50) from baseline to 3 months follow-up. Participants in the CARE Express (n = 48) and CARE (n = 49) groups had significant improvement in confidence in identifying/responding to emotions between baseline and 3 months post-training (p < 0.001), as well as their attitude toward psychosocial care (p < 0.001). A significant increase in ""acknowledging"" responses from baseline to 3 months was also observed for CARE Express and CARE (p < 0.001), with no difference between groups. CARE Express and CARE resulted in changes in confidence in emotional identification/response, psychosocial focus and communication skills maintained at 3 months post-training. Whilst the 1-day workshop has been regarded as gold standard, this study has revealed positive outcomes with a modified 2-h version, thus offering a potential alternate training model.",2020,"CARE Express and CARE resulted in changes in confidence in emotional identification/response, psychosocial focus and communication skills maintained at 3 months post-training.","['Participants in the CARE Express (n\u2009=\u200948) and CARE (n\u2009', 'Cancer care health professionals (n\u2009=\u2009147) were recruited from allied health, nursing and medical disciplines, using a partial randomisation to allocate to three arms', 'Health Professionals Working in Cancer Care']","['Communication Training Workshops', 'control, two-hour training (CARE Express) and 1-day training (CARE']","['acknowledging"" responses', 'attitude toward psychosocial care', 'Perceived confidence and skills', 'health professional confidence, skills and attitudes', 'Physician Belief Scale', 'confidence in identifying/responding to emotions', 'confidence in emotional identification/response, psychosocial focus and communication skills']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0043227', 'cui_str': 'Work'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0222045'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}]",147.0,0.0210218,"CARE Express and CARE resulted in changes in confidence in emotional identification/response, psychosocial focus and communication skills maintained at 3 months post-training.","[{'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Nixon', 'Affiliation': 'Occupational Therapy Department, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia. jodie.nixon@health.qld.gov.au.'}, {'ForeName': 'Lyndal', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'Occupational Therapy Department, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Turner', 'Affiliation': 'Faculty of Medicine, The University of Queensland, St Lucia, QLD, 4027, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Bernard', 'Affiliation': 'QFAB Bioinformatics, Institute for Molecular Bioscience, The University of Queensland, St Lucia, QLD, 4027, Australia.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Scaife', 'Affiliation': 'Cancer Services, Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Brisbane, 4102, Australia.'}, {'ForeName': 'Bena', 'Initials': 'B', 'LastName': 'Cartmill', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, St Lucia, Australia.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1439-0']
461,31824142,Exercise Training Induced Changes In Nuclear Magnetic Resonance-Measured Lipid Particles In Mild Cognitively Impaired Elderly African American Volunteers: A Pilot Study.,"Purpose


Poor cardiorespiratory fitness (CRF) is linked to cognitive deterioration, but its effects on lipid heterogeneity and functional properties in older African American (AA) subjects with mild cognitive impairment (MCI) need elucidation. This study determined whether exercise training-induced changes in blood lipid particle sizes (LPS) were associated with CRF determined by VO 2 Max in elderly AAs with MCI. Given the pivotal role of brain-derived neurotrophic factor (BDNF) on glucose metabolism, and therefore, ""diabetic dyslipidemia"", we also determined whether changes in LPS were associated with the levels of serum BDNF.
Methods


This analysis included 17 of the 29 randomized elderly AAs with MCI who had NMR data at baseline and after a 6-month training. We used Generalized Linear Regression (GLM) models to examine cardiorespiratory fitness (VO 2 Max) effects on training-induced change in LPS in the stretch and aerobic groups. Additionally, we determined whether the level of BDNF influenced change in LPS.
Results


Collectively, mean VO 2 Max (23.81±6.17) did not differ significantly between aerobic and stretch groups (difference=3.17±3.56,  P =0.495). Training-related changes in very low-density lipoprotein, chylomicrons, and total low-density lipoprotein (LDL) particle sizes correlated significantly with VO 2 Max, but not after adjustment for age and gender. However, increased VO 2 Max significantly associated with reduced total LDL particle size after similar adjustments ( P  = 0.046). While stretch exercise associated with increased protective large high-density lipoprotein particle size, the overall effect was not sustained following adjustments for gender and age. However, changes in serum BDNF were associated with changes in triglyceride and cholesterol transport particle sizes ( P  < 0.051).
Conclusion


Promotion of stretch and aerobic exercise to increase CRF in elderly AA volunteers with MCI may also promote beneficial changes in lipoprotein particle profile. Because high BDNF concentration may reduce CVD risk, training-related improvements in BDNF levels are likely advantageous. Large randomized studies are needed to confirm our observations and to further elucidate the role for exercise therapy in reducing CVD risk in elderly AAs with MCI.",2019,"However, increased VO 2 Max significantly associated with reduced total LDL particle size after similar adjustments ( P  = 0.046).","['elderly AA volunteers with', '17 of the 29 randomized elderly AAs with MCI who had NMR data at baseline and after a 6-month training', 'older African American (AA) subjects with mild cognitive impairment (MCI', 'Mild Cognitively Impaired Elderly African American Volunteers']","['Exercise Training', 'exercise training', 'brain-derived neurotrophic factor (BDNF', 'MCI', 'stretch and aerobic exercise', 'exercise therapy']","['triglyceride and cholesterol transport particle sizes', 'mean VO 2 Max', 'very low-density lipoprotein, chylomicrons, and total low-density lipoprotein (LDL) particle sizes', 'blood lipid particle sizes (LPS', 'serum BDNF', 'Nuclear Magnetic Resonance-Measured Lipid Particles', 'protective large high-density lipoprotein particle size', 'BDNF levels', 'total LDL particle size', 'level of BDNF influenced change in LPS']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0030608', 'cui_str': 'Particle Size'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0008731', 'cui_str': 'Chylomicrons'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.0484892,"However, increased VO 2 Max significantly associated with reduced total LDL particle size after similar adjustments ( P  = 0.046).","[{'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'Fungwe', 'Affiliation': 'Department of Nutritional Sciences, School of Nursing and Allied Health Sciences, Howard University, Washington, DC, USA.'}, {'ForeName': 'Julius S', 'Initials': 'JS', 'LastName': 'Ngwa', 'Affiliation': 'Division of Cardiology, Department of Medicine, Howard University, Washington, DC, USA.'}, {'ForeName': 'Oyonumo E', 'Initials': 'OE', 'LastName': 'Ntekim', 'Affiliation': 'Department of Nutritional Sciences, School of Nursing and Allied Health Sciences, Howard University, Washington, DC, USA.'}, {'ForeName': 'Joanne S', 'Initials': 'JS', 'LastName': 'Allard', 'Affiliation': 'Division of Cardiology, Department of Physiology and Biophysics, Howard University, Washington, DC, USA.'}, {'ForeName': 'Sheeba', 'Initials': 'S', 'LastName': 'Nadarajah', 'Affiliation': 'Division of Nursing, College of Nursing and Allied Health Sciences, Howard University, Washington, DC, USA.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Wolday', 'Affiliation': 'Division of Geriatrics, Department of Medicine and Clinical, Howard University Hospital, Washington, DC, USA.'}, {'ForeName': 'Oludolapo O', 'Initials': 'OO', 'LastName': 'Ogunlana', 'Affiliation': 'Division of Geriatrics, Department of Medicine and Clinical, Howard University Hospital, Washington, DC, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Johnson', 'Affiliation': 'Division of Geriatrics, Department of Medicine and Clinical, Howard University Hospital, Washington, DC, USA.'}, {'ForeName': 'Kakra', 'Initials': 'K', 'LastName': 'Hughes', 'Affiliation': 'Department of Surgery, Howard University College of Medicine, Washington, DC, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Larbi', 'Affiliation': 'Division of Geriatrics, Department of Medicine and Clinical, Howard University Hospital, Washington, DC, USA.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Gillum', 'Affiliation': 'Department of Internal Medicine, Howard University Hospital, Washington, DC, USA.'}, {'ForeName': 'Thomas O', 'Initials': 'TO', 'LastName': 'Obisesan', 'Affiliation': 'Division of Geriatrics, Department of Medicine and Clinical, Howard University Hospital, Washington, DC, USA.'}]",Clinical interventions in aging,['10.2147/CIA.S195878']
462,31021875,The Effect of Intraoperative Vertebral Anesthesia on Osteoporotic Fractures Treated With Percutaneous Kyphoplasty: A Prospective Cohort Study.,"STUDY DESIGN


A prospective randomized cohort study.
OBJECTIVE


The objective of this study was to investigate the effect of intraoperative vertebral anesthesia on osteoporotic vertebral compression fractures (OVCFs) when treated with percutaneous kyphoplasty (PKP).
SUMMARY OF BACKGROUND DATA


Only a few studies have evaluated the intraoperative pain reducing strategies during PKP.
MATERIALS AND METHODS


A total of 64 patients with OVCFs were enrolled in the study. All of the patients were randomized into 2 groups: the traditional local anesthesia group (from the skin to the periosteum, group A) and the experimental group (from the skin to a vertebral body, group B). Visual Analogue Scale (VAS) score was used to evaluate the degree of pain at six time points, that is, VAS before surgery, VAS during balloon dilation, VAS during bone cement injection, VAS soon after surgery, and VAS 12 hours and 24 hours after surgery. In addition, we noted the patients' willingness to undergo reoperation if necessary, and the variations in surgical complications between the 2 groups.
RESULTS


There was no significant difference in VAS score before surgery between the 2 groups (t=1.694, P=0.095). The VAS scores during balloon dilatation, bone cement injection and soon after surgery were significantly different between the 2 groups (t=4.405, P=0.000; t=2.481, P=0.016; t=2.992, P=0.004, respectively). The willingness to undergo reoperation was significantly different between 2 groups (χ=6.020, P=0.049), whereas the complications showed no significant difference (χ=0.000, P=0.754).
CONCLUSIONS


Traditional local anesthesia combined with vertebral anesthesia was effective in alleviating perioperative pain during PKP. No serious complication was noted during the operation.
LEVEL OF EVIDENCE


Level I.",2019,"The willingness to undergo reoperation was significantly different between 2 groups (χ=6.020, P=0.049), whereas the complications showed no significant difference (χ=0.000, P=0.754).
","['64 patients with OVCFs were enrolled in the study', 'Osteoporotic Fractures Treated With Percutaneous Kyphoplasty']","['intraoperative vertebral anesthesia', 'percutaneous kyphoplasty (PKP', 'vertebral anesthesia', 'Intraoperative Vertebral Anesthesia', 'traditional local anesthesia']","['perioperative pain', 'VAS score', 'willingness to undergo reoperation', 'VAS scores', 'osteoporotic vertebral compression fractures (OVCFs', 'surgical complications', 'serious complication', 'Visual Analogue Scale (VAS) score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic Fractures'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0521169', 'cui_str': 'Compression fracture (morphologic abnormality)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",64.0,0.0393237,"The willingness to undergo reoperation was significantly different between 2 groups (χ=6.020, P=0.049), whereas the complications showed no significant difference (χ=0.000, P=0.754).
","[{'ForeName': 'Genwen', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': 'Department of Orthopedics, State Key Clinical Department of China.'}, {'ForeName': 'Dereje G', 'Initials': 'DG', 'LastName': 'Alemayehu', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Xi'an Jiaotong University.""}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Xi'an Jiaotong University.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wen', 'Affiliation': ""Department of Orthopedics, The First Affiliated Hospital of Xi'an Jiaotong University.""}, {'ForeName': 'Yiyan', 'Initials': 'Y', 'LastName': 'Ou', 'Affiliation': ""The Medical College of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""The Medical College of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Department of Orthopedics, State Key Clinical Department of China.'}]",Clinical spine surgery,['10.1097/BSD.0000000000000823']
463,32041897,Colocalized White Matter Plasticity and Increased Cerebral Blood Flow Mediate the Beneficial Effect of Cardiovascular Exercise on Long-Term Motor Learning.,"Cardiovascular exercise (CE) is a promising intervention strategy to facilitate cognition and motor learning in healthy and diseased populations of all ages. CE elevates humoral parameters, such as growth factors, and stimulates brain changes potentially relevant for learning and behavioral adaptations. However, the causal relationship between CE-induced brain changes and human's ability to learn remains unclear. We tested the hypothesis that CE elicits a positive effect on learning via alterations in brain structure (morphological changes of gray and white matter) and function (functional connectivity and cerebral blood flow in resting state). We conducted a randomized controlled trial with healthy male and female human participants to compare the effects of a 2 week CE intervention against a non-CE control group on subsequent learning of a challenging new motor task (dynamic balancing; DBT) over 6 consecutive weeks. We used multimodal neuroimaging [T1-weighted magnetic resonance imaging (MRI), diffusion-weighted MRI, perfusion-weighted MRI, and resting state functional MRI] to investigate the neural mechanisms mediating between CE and learning. As expected, subjects receiving CE subsequently learned the DBT at a higher rate. Using a modified nonparametric combination approach along with multiple mediator analysis, we show that this learning boost was conveyed by CE-induced increases in cerebral blood flow in frontal brain regions and changes in white matter microstructure in frontotemporal fiber tracts. Our study revealed neural mechanisms for the CE-learning link within the brain, probably allowing for a higher flexibility to adapt to highly novel environmental stimuli, such as learning a complex task. SIGNIFICANCE STATEMENT  It is established that cardiovascular exercise (CE) is an effective approach to promote learning and memory, yet little is known about the underlying neural transfer mechanisms through which CE acts on learning. We provide evidence that CE facilitates learning in human participants via plasticity in prefrontal white matter tracts and a colocalized increase in cerebral blood flow. Our findings are among the first to demonstrate a transfer potential of experience-induced brain plasticity. In addition to practical implications for health professionals and coaches, our work paves the way for future studies investigating effects of CE in patients suffering from prefrontal hypoperfusion or white matter diseases.",2020,We provide evidence that CE facilitates learning in human participants via plasticity in prefrontal white matter tracts and a co-localized increase in cerebral blood flow.,"['healthy and diseased populations of all ages', 'patients suffering from prefrontal hypoperfusion or white matter diseases', 'healthy, male and female human participants']","['CE intervention against a non-CE control group on subsequent learning of a challenging new motor task (dynamic balancing, DBT', 'Cardiovascular exercise (CE', 'Cardiovascular Exercise', 'CE', 'cardiovascular exercise (CE']","['learning via alterations in brain structure (morphological changes of gray and white matter) and function (functional connectivity and cerebral blood flow in resting state', 'cerebral blood flow', 'Cerebral Blood Flow Mediate']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442856', 'cui_str': 'Hypoperfusion (qualifier value)'}, {'cui': 'C0270612', 'cui_str': 'White Matter Diseases'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1269776', 'cui_str': 'Gray'}, {'cui': 'C0682708'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}]",,0.0330105,We provide evidence that CE facilitates learning in human participants via plasticity in prefrontal white matter tracts and a co-localized increase in cerebral blood flow.,"[{'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Lehmann', 'Affiliation': 'Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences, 04103 Leipzig, Germany, nico1.lehmann@ovgu.de.'}, {'ForeName': 'Arno', 'Initials': 'A', 'LastName': 'Villringer', 'Affiliation': 'Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences, 04103 Leipzig, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Taubert', 'Affiliation': 'Department of Neurology, Max Planck Institute for Human Cognitive and Brain Sciences, 04103 Leipzig, Germany.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.2310-19.2020']
464,30507281,"Men on the Move: A Randomized Controlled Feasibility Trial of a Scalable, Choice-Based, Physical Activity and Active Transportation Intervention for Older Men.","We conducted Men on the Move, a 12-week randomized controlled feasibility trial of a scalable, choice-based, physical activity (PA) and active transportation intervention. Participants were community-dwelling men aged 60 years and older (n = 29 intervention [INT] and n = 29 waitlist control [CON]). Trained activity coaches delivered: (a) one-on-one participant consultations to develop personal action plans for PA and active transportation, (b) monthly group-based motivational meetings, (c) weekly telephone support, (d) complimentary recreation and transit passes, and (e) pedometers and diaries for self-monitoring. Men on the Move demonstrated high rates of recruitment, retention, and intervention adherence. INT chose a variety of group-based and individual PAs and destinations for their personal action plans. At 12 weeks, INT achieved more steps, moderate-vigorous PA, and energy expenditure than CON. INT was also more likely to take transit and meet national guideline levels of PA. At 24 weeks follow-up, INT benefits were sustained for moderate-vigorous PA and energy expenditure.",2019,"At 12 weeks, INT achieved more steps, moderate-vigorous PA, and energy expenditure than CON.","['Older Men', 'Participants were community-dwelling men aged 60 years and older (n\u2009=\u200929 intervention [INT] and n\u2009=\u200929 waitlist control [CON']","['scalable, choice-based, physical activity (PA) and active transportation intervention', 'Trained activity coaches delivered: (a)\xa0one-on-one participant consultations to develop personal action plans for PA and active transportation, (b)\xa0monthly group-based motivational meetings, (c)\xa0weekly telephone support, (d)\xa0complimentary recreation and transit passes, and (e)\xa0pedometers and diaries for self-monitoring', 'Scalable, Choice-Based, Physical Activity and Active Transportation Intervention']","['rates of recruitment, retention, and intervention adherence', 'INT achieved more steps, moderate-vigorous PA, and energy expenditure']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0556656', 'cui_str': 'Meetings (procedure)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}]",,0.0230887,"At 12 weeks, INT achieved more steps, moderate-vigorous PA, and energy expenditure than CON.","[{'ForeName': 'Dawn C', 'Initials': 'DC', 'LastName': 'Mackey', 'Affiliation': ''}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Perkins', 'Affiliation': ''}, {'ForeName': 'Kaitlin', 'Initials': 'K', 'LastName': 'Hong Tai', 'Affiliation': ''}, {'ForeName': 'Joanie', 'Initials': 'J', 'LastName': 'Sims-Gould', 'Affiliation': ''}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'McKay', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2018-0137']
465,32205221,Long-Term Efficacy and Tolerability of RPC4046 in an Open-Label Extension Trial of Patients With Eosinophilic Esophagitis.,"BACKGROUND & AIMS


The short-term efficacy of PC4046, a monoclonal antibody against interleukin-13, has been shown in patients with eosinophilic esophagitis (EoE). We investigated the long-term efficacy and safety of RPC4046 in an open-label, long-term extension (LTE) study in adults with EoE.
METHODS


We analyzed data from 66 patients who coRmpleted the 16-week, double-blind, induction portion of a phase 2 study of RPC4046 (180 mg or 360 mg/wk) vs placebo and then completed a 52-week LTE, receiving open-label RPC4046 360 mg/wk. The study was conducted at 28 centers in 3 countries; patients were enrolled between September 2014 and January 2017. Outcomes were stratified by double-blind dose group and included esophageal eosinophil counts, EoE endoscopic reference score, EoE histologic scoring system score, symptom-based EoE activity index score, and safety.
RESULTS


By week 12 of the LTE, esophageal eosinophil mean and peak counts, total EoE endoscopic reference scores, and EoE histologic scoring system grade and stage scores did not differ considerably between patients who originally received placebo vs RPC4046. Most patients maintained responses through week 52. Symptom remission (symptom-based EoE activity index score, ≤20) increased from 14% at LTE entry to 67% at LTE week 52 in placebo‒RPC4046 patients and from 30% to 54% in RPC4046‒RPC4046 (either dose) patients. Of the 28 patients who did not have a histologic response to RPC4046 during the double-blind induction phase, 10 patients (36%) achieved response during the LTE. The most common adverse events were upper respiratory tract infection (21%) and nasopharyngitis (14%).
CONCLUSIONS


One year of treatment with RPC4046 is generally well tolerated and results in continued improvement and/or maintenance of endoscopic, histologic, and clinical measures of EoE disease activity relative to baseline.
TRIAL REGISTRATION


NCT02098473.",2020,"The most common adverse events were upper respiratory tract infection (21%) and nasopharyngitis (14%).
","['Patients With Eosinophilic Esophagitis', 'patients with eosinophilic esophagitis (EoE', '66 patients who completed the 16-week double-blind induction portion of a phase 2 study of', '28 centers in 3 countries; patients were enrolled between September 2014 and January 2017', 'adults with EoE']","['RPC4046', 'LTE, receiving open-label RPC4046', 'placebo']","['nasopharyngitis', 'histologic response to RPC4046', 'esophageal eosinophil mean and peak counts, total EoE endoscopic reference scores, and EoE histologic scoring system grade and stage scores', 'esophageal eosinophil counts, EoE endoscopic reference score, EoE histologic scoring system score, symptom-based EoE activity index score, and safety', 'Symptom remission (symptom-based EoE activity index score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0341106', 'cui_str': 'Chronic Esophagitis, Eosinophilic'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4547951', 'cui_str': 'RPC4046'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C4547951', 'cui_str': 'RPC4046'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count - observation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",,0.191745,"The most common adverse events were upper respiratory tract infection (21%) and nasopharyngitis (14%).
","[{'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina. Electronic address: evan_dellon@med.unc.edu.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Collins', 'Affiliation': ""Division of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Marc E', 'Initials': 'ME', 'LastName': 'Rothenberg', 'Affiliation': ""Division of Allergy and Immunology, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Yehudith', 'Initials': 'Y', 'LastName': 'Assouline-Dayan', 'Affiliation': 'Carver College of Medicine, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Evans', 'Affiliation': 'Grand Teton Research Group, Idaho Falls, Idaho.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ""University of Illinois College of Medicine, Children's Hospital of Illinois, Peoria, Illinois.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Schoepfer', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Straumann', 'Affiliation': 'Swiss EoE Clinic, Olten, Switzerland.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Safroneeva', 'Affiliation': 'Institute of Social and Preventative Medicine, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Rodriguez', 'Affiliation': 'Celgene Corporation, Summit, New Jersey.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Minton', 'Affiliation': 'Celgene Corporation, Summit, New Jersey.'}, {'ForeName': 'Steven Y', 'Initials': 'SY', 'LastName': 'Hua', 'Affiliation': 'Celgene Corporation, Summit, New Jersey.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Hirano', 'Affiliation': 'Feinberg School of Medicine, Chicago, Illinois.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.03.036']
466,32205226,Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma.,"BACKGROUND & AIMS


Patients with hepatocellular carcinoma (HCC) secondary to chronic liver disease often require invasive procedures but frequently have thrombocytopenia. Lusutrombopag is an agonist of the thrombopoietin receptor that activates platelet production.
METHODS


We performed an integrated analysis of data from 2 phase 3 trials (L-PLUS 1, Japan, October 2013 to May 2014, and L-PLUS 2, global, June 2015 to April 2017) that compared the efficacy and safety of lusutrombopag with placebo in patients with chronic liver disease, with and without HCC. Our analysis included patients with Eastern Cooperative Oncology Group grades of 0 or 1, Child-Pugh classes A or B, and a platelet count less than 50 × 10 9 /L who were scheduled to undergo invasive procedures in 9 to 14 days. Patients received lusutrombopag (3 mg) or placebo daily for 7 days or fewer before an invasive procedure. Imaging studies assessed treatment-emergent adverse events, including asymptomatic portal vein thrombosis. The primary end point was no requirement for platelet transfusion before the invasive procedure and rescue therapies for bleeding 7 days or fewer after the invasive procedure.
RESULTS


The per-protocol population included 270 patients (95 with HCC). A significantly higher proportion of patients with HCC who received lusutrombopag achieved the primary end point (68.0%) vs patients who received placebo (8.9%) (P < .0001); in patients without HCC, these proportions were 77.0% vs 21.6% (P < .0001). Lusutrombopag reduced the need for platelet transfusions, increased platelet counts for 3 weeks, and reduced the number of bleeding events in patients with and without HCC compared with placebo. Risk of thrombosis was similar to that of placebo.
CONCLUSIONS


Patients with and without HCC receiving lusutrombopag had a reduction in the number of platelet transfusions before invasive procedures compared with patients receiving placebo, with no increase in thrombosis or bleeding. L-PLUS 1: JapicCTI-132323; L-PLUS 2: ClinicalTrials.gov number no: NCT02389621.",2020,"The primary endpoint was no requirement for platelet transfusion before the invasive procedure or rescue therapies for bleeding 7 days or less after the invasive procedure.
","['patients with chronic liver disease, with and without HCC', '270 patients (95 with HCC', 'patients with ECOG grades of 0 or 1, Child', 'Patients with hepatocellular carcinoma (HCC', 'Patients With and Without Hepatocellular Carcinoma']","['placebo', 'lusutrombopag (3 mg) or placebo', 'Lusutrombopag', 'lusutrombopag to placebo']","['Risk of thrombosis', 'number of bleeding events', 'number of platelet transfusions', 'platelet counts', 'platelet transfusion', 'thrombosis or bleeding', 'asymptomatic portal vein thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4309207', 'cui_str': 'lusutrombopag'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0086818', 'cui_str': 'Blood Platelet Transfusion'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0155773', 'cui_str': 'Portal vein thrombosis (disorder)'}]",,0.350149,"The primary endpoint was no requirement for platelet transfusion before the invasive procedure or rescue therapies for bleeding 7 days or less after the invasive procedure.
","[{'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Department of Metabolic Center, Texas Liver Institute, San Antonio, Texas. Electronic address: alkhouri@txliver.com.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Imawari', 'Affiliation': 'Institute for Gastrointestinal and Liver Disease, Shin-Yurigaoka General Hospital, Kawasaki, Japan.'}, {'ForeName': 'Namiki', 'Initials': 'N', 'LastName': 'Izumi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Osaki', 'Affiliation': 'Meiwa Hospital, Nishinomiya, Japan.'}, {'ForeName': 'Toshimitsu', 'Initials': 'T', 'LastName': 'Ochiai', 'Affiliation': 'Biostatistics Center, Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kano', 'Affiliation': 'Global Project Management Department, Shionogi & Co, Ltd, Osaka, Japan.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Bentley', 'Affiliation': 'Global Market Access, Shionogi, Inc, Florham Park, New Jersey.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Trevisani', 'Affiliation': 'Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.03.032']
467,30393060,The Accuracy of Self-Screening of Group B Streptococcus in Pregnant Women-A Randomized Crossover Study.,"OBJECTIVE


Universal screening of vaginal and rectal group B streptococcus (GBS) carriage in pregnant women is now recommended in many countries to identify at-risk pregnancies and reduce the risk of early-onset GBS disease in newborn infants. This study compared self-screening by pregnant women with screening by health care workers in a largely Chinese population.
METHODS


A randomized crossover study was conducted in Hong Kong. All women attending the GBS screening visit at 35-37 weeks gestation between May and October 2015 were approached for recruitment. Consenting participants underwent both self-screening and screening by health care workers. Group 1 had health care worker screening swabs first, and group 2 had self-screening first. A positive GBS diagnosis was made if either swab was positive. The sensitivity of each approach was calculated by comparison with this gold standard. Acceptance of GBS self-screening and neonatal outcomes was analyzed (Canadian Task Force Classification I).
RESULTS


Of the 672 women approached, 428 (63.7%) consented to the study. The prevalence of GBS was 19.7% (83 of 422). Sensitivities of self-screening and screening by health care workers were 61.4% (51 of 83) and 97.6% (81 of 83), respectively (P < 0.05). Women who used vaginal pessaries and non-Chinese women had a higher positive concordance rate with health care workers (P < 0.05). Neonatal outcomes of GBS-positive mothers were similar in the concordant and discordant groups.
CONCLUSION


The sensitivity of self-screening of GBS in Hong Kong was lower than the sensitivity of screening by health care workers. Cultural difference needs to be considered when implementing self-screening in different populations.",2019,The sensitivity of self-screening of GBS in Hong Kong was lower than the sensitivity of screening by health care workers.,"['newborn infants', 'Pregnant Women', 'All women attending the GBS screening visit at 35-37 weeks gestation between May and October 2015 were approached for recruitment', 'Group 1 had health care worker screening swabs first, and group 2 had self-screening first', 'pregnant women', '672 women approached, 428 (63.7%) consented to the study', 'pregnant women with screening by health care workers in a largely Chinese population', 'Consenting participants underwent both self-screening and screening by health care workers']",['vaginal and rectal group B streptococcus (GBS'],"['sensitivity of self-screening of GBS', 'prevalence of GBS', 'positive concordance rate with health care workers', 'Sensitivities of self-screening and screening by health care workers']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4517775', 'cui_str': 'Four hundred and twenty-eight'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0579233', 'cui_str': 'Streptococcus agalactiae'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",672.0,0.119281,The sensitivity of self-screening of GBS in Hong Kong was lower than the sensitivity of screening by health care workers.,"[{'ForeName': 'Mimi T Y', 'Initials': 'MTY', 'LastName': 'Seto', 'Affiliation': 'Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, Hong Kong. Electronic address: mimiseto@gmail.com.'}, {'ForeName': 'Jennifer K Y', 'Initials': 'JKY', 'LastName': 'Ko', 'Affiliation': 'Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'Ka Wang', 'Initials': 'KW', 'LastName': 'Cheung', 'Affiliation': 'Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'Kelvin K W', 'Initials': 'KKW', 'LastName': 'To', 'Affiliation': 'Department of Microbiology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.'}, {'ForeName': 'Pui Wah', 'Initials': 'PW', 'LastName': 'Hui', 'Affiliation': 'Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'Terence T', 'Initials': 'TT', 'LastName': 'Lao', 'Affiliation': 'Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, Hong Kong.'}, {'ForeName': 'Chin Peng', 'Initials': 'CP', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, Hong Kong.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2018.08.003']
468,32215633,Cost-effectiveness of Mifepristone Pretreatment for the Medical Management of Nonviable Early Pregnancy: Secondary Analysis of a Randomized Clinical Trial.,"Importance


Early pregnancy loss (EPL) is the most common complication of pregnancy. A multicenter randomized clinical trial compared 2 strategies for medical management and found that mifepristone pretreatment is 25% more effective than the standard of care, misoprostol alone. The cost of mifepristone may be a barrier to implementation of the regimen.
Objective


To assess the cost-effectiveness of medical management of EPL with mifepristone pretreatment plus misoprostol vs misoprostol alone in the United States.
Design, Setting, and Participants


This preplanned. prospective economic evaluation was performed concurrently with a randomized clinical trial in 3 US sites from May 1, 2014, through April 30, 2017. Participants included 300 women with anembryonic gestation or embryonic or fetal demise. Cost-effectiveness was computed from the health care sector and societal perspectives, with a 30-day time horizon. Data were analyzed from July 1, 2018, to July 3, 2019.
Interventions


Mifepristone pretreatment plus misoprostol administration vs misoprostol alone.
Main Outcomes and Measures


Costs in 2018 US dollars, effectiveness in quality-adjusted life-years (QALYs), and treatment efficacy. Incremental cost-effectiveness ratios (ICERs) of mifepristone and misoprostol vs misoprostol alone were calculated, and cost-effectiveness acceptability curves were generated.
Results


Among the 300 women included in the randomized clinical trial (mean [SD] age, 30.4 [6.2] years), mean costs were similar for groups receiving mifepristone pretreatment and misoprostol alone from the health care sector perspective ($696.75 [95% CI, $591.88-$801.62] vs $690.88 [95% CI, $562.38-$819.38]; P = .94) and the societal perspective ($3846.30 [95% CI, $2783.01-$4909.58] vs $4845.62 [95% CI, $3186.84-$6504.41]; P = .32). The mifepristone pretreatment group had higher QALYs (0.0820 [95% CI, 0.0815-0.0825] vs 0.0806 [95% CI, 0.0800-0.0812]; P = .001) and a higher completion rate after first treatment (83.8% vs 67.1%; P < .001) than the group receiving misoprostol alone. From the health care sector perspective, mifepristone pretreatment was cost-effective relative to misoprostol alone with an ICER of $4225.43 (95% CI, -$195 053.30 to $367 625.10) per QALY gained. From the societal perspective, mifepristone pretreatment dominated misoprostol alone (95% CI, -$5 111 629 to $1 801 384). The probabilities that mifepristone pretreatment was cost-effective compared with misoprostol alone at a willingness-to-pay of $150 000 per QALY gained from the health care sector and societal perspectives were approximately 90% and 80%, respectively.
Conclusions and Relevance


This study found that medical management of EPL with mifepristone pretreatment was cost-effective when compared with misoprostol alone.
Trial Registration


ClinicalTrials.gov Identifier: NCT02012491.",2020,The mifepristone pretreatment group had higher QALYs (0.0820,"['300 women included in the randomized clinical trial (mean [SD] age, 30.4 [6.2] years', 'Participants included 300 women with anembryonic gestation or embryonic or fetal demise', '3 US sites from May 1, 2014, through April 30, 2017', 'Early Pregnancy']","['EPL with mifepristone pretreatment plus misoprostol vs misoprostol', 'mifepristone and misoprostol vs misoprostol', 'mifepristone pretreatment and misoprostol', 'EPL with mifepristone', 'mifepristone', 'Mifepristone pretreatment plus misoprostol administration vs misoprostol alone', 'Mifepristone', 'misoprostol']","['cost-effectiveness acceptability curves', 'cost-effective', 'societal perspective', 'higher completion rate', 'Cost-effectiveness', 'Incremental cost-effectiveness ratios (ICERs', 'Measures\n\n\nCosts in 2018 US dollars, effectiveness in quality-adjusted life-years (QALYs), and treatment efficacy', 'mean costs']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4524250', 'cui_str': 'Anembryonic gestation'}, {'cui': 'C0015927', 'cui_str': 'Fetal Demise'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0562019', 'cui_str': 'dollar (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",300.0,0.187961,The mifepristone pretreatment group had higher QALYs (0.0820,"[{'ForeName': 'Divyah', 'Initials': 'D', 'LastName': 'Nagendra', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Nathanael', 'Initials': 'N', 'LastName': 'Koelper', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Loza-Avalos', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Sonalkar', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California, Davis, Sacramento.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Atrio', 'Affiliation': 'Department of Obstetrics and Gynecology, Montefiore Hospital, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Heidi S', 'Initials': 'HS', 'LastName': 'Harvie', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.1594']
469,32055002,Survival outcomes and risk group validation from SWOG S0925: a randomized phase II study of cixutumumab in new metastatic hormone-sensitive prostate cancer.,"BACKGROUND


Cixutumumab, a monoclonal antibody targeting insulin-like growth factor I receptor, did not improve undetectable prostate-specific antigen (PSA) rate at 28 weeks when combined with androgen deprivation in the randomized phase II SWOG S0925 trial for patients with new metastatic hormone-sensitive prostate cancer. We now present mature survival analyses, along with pre-specified secondary and exploratory endpoints.
METHODS


We randomized 210 patients to androgen deprivation with or without cixutumumab, 105 per treatment arm. We used Kaplan-Meier curves to analyze overall survival, radiographic progression-free survival, and castration resistance-free survival by treatment arm, disease volume, and risk group. We explored differences in survival by treatment arm via covariate-adjusted Cox proportional hazards models adjusted for disease volume and risk.
RESULTS


No difference was seen between treatment arms in overall survival (HR 1.01 [0.70-1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85-1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p = 0.88). At baseline, 105/198 (53.0%) patients had high-risk features and 119/210 (56.7%) had high-volume disease; 16.7% of patients had discordant classifications of high or low category for risk and volume. Adjusting for risk or volume yielded no differences in overall survival between arms. Inferior survival was observed in high-risk (HR 1.89 [1.29-2.80]; p = 0.001) and high-volume (HR 2.75 [1.84-4.10]; p < 0.0001) disease. Disease volume was a better fit to survival data than risk group (AIC 878.3 vs. 889.2). Compared to patients achieving undetectable PSA at 28 weeks, inferior survival was observed in patients whose PSA was >0.2 to ≤4.0 ng/mL (HR 3.72 [1.99-6.95]; p < 0.0001) or >4.0 ng/mL (HR 7.13 [4.24-11.9]; p < 0.0001).
CONCLUSIONS


In new metastatic hormone-sensitive prostate cancer, addition of cixutumumab to androgen deprivation did not improve survival. Baseline risk and disease volume carried prognostic value for this distinct trial population, although disease volume added more prognostic information. PSA treatment response was a strong intermediate endpoint for survival.",2020,"No difference was seen between treatment arms in overall survival (HR 1.01 [0.70-1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85-1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p = 0.88).","['patients with new metastatic hormone-sensitive prostate cancer', '210 patients to androgen deprivation with or without cixutumumab, 105 per treatment arm', 'new metastatic hormone-sensitive prostate cancer']",['cixutumumab'],"['Inferior survival', 'radiographic progression-free survival', 'inferior survival', 'Survival outcomes', 'overall survival, radiographic progression-free survival, and castration resistance-free survival', 'castration resistance-free survival', 'survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C2699335'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]",[{'cui': 'C2699335'}],"[{'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}]",210.0,0.28146,"No difference was seen between treatment arms in overall survival (HR 1.01 [0.70-1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85-1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p = 0.88).","[{'ForeName': 'Risa L', 'Initials': 'RL', 'LastName': 'Wong', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Mai T', 'Initials': 'MT', 'LastName': 'Duong', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Heather H', 'Initials': 'HH', 'LastName': 'Cheng', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'US Oncology, Las Vegas, NV, USA.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'CHRISTUS Santa Rosa Medical Center Hospital, San Antonio, TX, USA.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Evan Y', 'Initials': 'EY', 'LastName': 'Yu', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, WA, USA. evanyu@uw.edu.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0210-x']
470,32212542,UNDERSTANDING PROLACTIN REGULATION AND DETERMINING THE EFFICACY OF CABERGOLINE AND DOMPERIDONE TO MITIGATE PROLACTIN-ASSOCIATED OVARIAN CYCLE PROBLEMS IN ZOO AFRICAN ELEPHANTS ( LOXODONTA AFRICANA  ).,"Perturbations in serum prolactin secretion, both over- and underproduction, are observed in zoo African elephants ( Loxodonta africana ) that exhibit abnormal ovarian cycles. Similar prolactin problems are associated with infertility in other species. Pituitary prolactin is held under constant inhibition by a hypothalamic-derived neurotransmitter, dopamine; thus, regulation by exogenous treatment with agonists or antagonists may be capable of reinitiating normal ovarian cycles. This study tested the efficacy of oral administration of cabergoline (agonist) and domperidone (antagonist) as possible treatments for hyperprolactinemia or chronic low prolactin, respectively. Hyperprolactinemic (overall mean prolactin, >30 ng/ml), acyclic elephants were administered oral cabergoline (2 mg,  n  = 4) or placebo (dextrose capsule,  n  = 4) twice weekly. Overall mean prolactin concentration decreased in treated females compared with controls (32.22 ± 14.75 vs 77.53 ± 0.96 ng/ml;  P  = 0.01). Interestingly, overall mean progestagen concentrations also increased slightly ( P  < 0.05) in treated females (0.15 ± 0.01 ng/ml) compared with controls (0.07 ± 0.01 ng/ml), but no reinitation of normal cyclic patterns was observed. Chronic low prolactin (overall mean prolactin, <10 ng/ml), acyclic females were orally administered domperidone (2 g/day,  n  = 4) or placebo (dextrose capsule,  n  = 4) for 4 wk, followed by 8 wk of no treatment (four cycles) to simulate the prolactin pattern observed in normal cycling elephants. Overall mean prolactin concentrations increased ( P  = 0.005) during domperidone treatment (21.77 ± 3.69 ng/ml) compared with controls (5.77 ± 0.46 ng/ml), but progestagen concentrations were unaltered. Prolactin regulation by dopamine was confirmed by expected responses to dopamine agonist and antagonist treatment. Although prolactin concentrations were successfully reduced by cabergoline, and domperidone initiated the expected cyclic prolactin pattern, neither treatment induced normal ovarian activity.",2020,Overall mean prolactin concentration decreased in treated females compared with controls (32.22 ± 14.75 vs 77.53 ± 0.96 ng/ml;  P  = 0.01).,['IN ZOO AFRICAN ELEPHANTS ( LOXODONTA AFRICANA  '],"['placebo (dextrose capsule', 'Pituitary prolactin', 'cabergoline (agonist) and domperidone (antagonist', 'domperidone', 'placebo (dextrose capsule,  n  = 4) twice weekly', 'oral cabergoline']","['normal ovarian activity', 'Chronic low prolactin', 'progestagen concentrations', 'Prolactin regulation', 'serum prolactin secretion', 'overall mean progestagen concentrations', 'Overall mean prolactin concentrations', 'Overall mean prolactin concentration', 'prolactin concentrations']","[{'cui': 'C0325156', 'cui_str': 'Loxodonta africana (organism)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0107994', 'cui_str': 'cabergoline'}, {'cui': 'C0013015', 'cui_str': 'Domperidone'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0033306', 'cui_str': 'Progestins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C1277972', 'cui_str': 'Serum prolactin measurement'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.132445,Overall mean prolactin concentration decreased in treated females compared with controls (32.22 ± 14.75 vs 77.53 ± 0.96 ng/ml;  P  = 0.01).,"[{'ForeName': 'Tina L', 'Initials': 'TL', 'LastName': 'Dow', 'Affiliation': 'Smithsonian Conservation Biology Institute, Smithsonian National Zoological Park, Front Royal, Virginia 22630, USA, tina.dow@ucf.edu.'}, {'ForeName': 'Dee L', 'Initials': 'DL', 'LastName': 'Cross', 'Affiliation': 'Equi-Tox Pharma, LLC, Central, South Carolina 29630, USA.'}, {'ForeName': 'Janine L', 'Initials': 'JL', 'LastName': 'Brown', 'Affiliation': 'Smithsonian Conservation Biology Institute, Smithsonian National Zoological Park, Front Royal, Virginia 22630, USA.'}]",Journal of zoo and wildlife medicine : official publication of the American Association of Zoo Veterinarians,['10.1638/2019-0017']
471,31495201,GENESIS: Phase III trial evaluating BL-8040 + G-CSF to mobilize hematopoietic cells for autologous transplant in myeloma.,"Effective hematopoietic cell transplantation relies upon collecting adequate numbers of CD34 +  hematopoietic stem cells, typically from peripheral blood. A minimum of ≥2 × 10 6  CD34 +  cells/kg are necessary, while transplants of ≥5-6 × 10 6  CD34 +  cells/kg are associated with improved hematopoietic recovery. Granulocyte colony stimulating factor (G-CSF) remains the gold standard for hematopoietic stem cell mobilization. However, in randomized trials for autologous-hematopoietic cell transplantation in multiple myeloma, approximately 45% of patients remain unable to optimally mobilize with G-CSF alone despite multiple injections and apheresis days. Therefore, reducing mobilization failures remains an unmet need. The study objective is to evaluate the superiority of one dose of BL-8040 plus G-CSF over placebo plus G-CSF to mobilize ≥6.0 × 10 6  CD34 +  cells/kg in up to two apheresis days. ClinicalTrials.gov: NCT03246529.",2019,The study objective is to evaluate the superiority of one dose of BL-8040 plus G-CSF over placebo plus G-CSF to mobilize ≥6.0 × 10 6  CD34 +  cells/kg in up to two apheresis days.,['autologous transplant in myeloma'],"['Granulocyte colony stimulating factor (G-CSF', 'BL-8040 plus G-CSF over placebo plus G-CSF', 'autologous-hematopoietic cell transplantation', 'BL-8040\xa0+\xa0G-CSF']",['hematopoietic recovery'],"[{'cui': 'C0559189', 'cui_str': 'Autotransplants'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C4521107', 'cui_str': 'BL-8040'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]",[],,0.113349,The study objective is to evaluate the superiority of one dose of BL-8040 plus G-CSF over placebo plus G-CSF to mobilize ≥6.0 × 10 6  CD34 +  cells/kg in up to two apheresis days.,"[{'ForeName': 'Zachary D', 'Initials': 'ZD', 'LastName': 'Crees', 'Affiliation': 'Department of Medicine, Division of Oncology, Washington University School of Medicine, St. Louis, MO 63108, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Stockerl-Goldstein', 'Affiliation': 'Department of Medicine, Division of Oncology, Washington University School of Medicine, St. Louis, MO 63108, USA.'}, {'ForeName': 'Abi', 'Initials': 'A', 'LastName': 'Vainstein', 'Affiliation': ""BioLineRx, Ltd, Modi'in, Israel.""}, {'ForeName': 'Hemda', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""BioLineRx, Ltd, Modi'in, Israel.""}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'DiPersio', 'Affiliation': 'Department of Medicine, Division of Oncology, Washington University School of Medicine, St. Louis, MO 63108, USA.'}]","Future oncology (London, England)",['10.2217/fon-2019-0380']
472,31684707,Effect of yoga combined with aerobic exercise intervention on morphological and blood lipid indicators in female college students.,"BACKGROUND


Regular aerobic exercise can effectively increase microvascular function in skeletal muscle and promote the oxidation of fatty acids. However, whether the effect of aerobic exercise intervention is affected by fat content is worth of further exploration. In this study, by means of yoga combined with exercise, the authors explored the effect of aerobic exercise on morphology and blood lipids in female college students.
METHODS


A total of 81 female college students who voluntarily participated in this study were enrolled by Body Mass Index (BMI) obtained from the physical examination when entering the school. The participants were assigned to normal (BMI: 20.98±1.52 kg/m2, N.=29), overweight (BMI: 25.57±1.34 kg/m2, N.=27), and obesity (BMI: 28.46±2.36 kg/m2, N.=25) groups by BMI, and all of them completed a 12-week Yoga combined with aerobic exercise training program. Relevant morphological such as body weight, body height, waist circumference, hip circumference, etc. and blood lipid indicators such as low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC) and triglyceride (TG) were measured before and after training. One-way ANVOA, paired-sample t-test were used in this study.
RESULTS


After training program, the results indicated that: 1) the hip, body weight, BMI and body fat percentage in all three groups significantly decreased; 2) waist circumference in normal and obesity groups had a significant change than that in overweight group, hip circumference and waist-to-hip ratio (WHR) in overweight group were better than those in normal and overweight groups; the decrease in BMI in overweight and obesity groups was significantly greater than that in normal group, and the weight loss and decreased body fat percentage in obesity group were the highest, followed by overweight group, and the smallest in normal group; 3) in all three groups, HDL-C significantly increased, LDL-C, TC/HDL-C, TG/HDL-C and LDL-C/HDL-C significantly decreased, TC and TG significantly decreased in obesity group; and 4) TC/HDL-C and TG/HDL-C in obesity group were significantly higher than those in normal and overweight groups, while change in TC and TG were the highest in obesity group, the second the overweight group, and the lowest in normal group.
CONCLUSIONS


Twelve-week yoga combined with aerobic exercise training has a significant positive effect on morphological and blood lipid indicators in female college students. The yoga combined with aerobic exercise training can be recommended for young women with overweight and obesity population.",2020,"After training program, the results indicated that 1) the hip, body weight, BMIand body fat percentage in all three groups significantly decreased; 2) waist circumference in normal and obesity groups had a significant change than that in overweight group, hip circumference and waist-to-hip ratio (WHR) in overweight group were better than those in normal and overweight groups; the decrease in BMI in overweight and obesity groups was significantly greater than that in normal group, and the weight loss and decreased body fat percentage in obesity group were the highest, followed by overweight group, and the smallest in normal group; 3) in all three groups, HDL-C significantly increased, LDL-C, TC/HDL-C, TG/HDL-C and LDL-C/HDL-C significantly decreased, TC and TG significantly decreased in obesity group; and 4) TC/HDL-C and TG/HDL-C in obesity group were significantly higher than those in normal and overweight groups, while change in TC and TG were the highest in obesity group, the second the overweight group, and the lowest in normal group.
","['female college students', '81 female college students who voluntarily participated in this study were enrolled by body mass index (BMI) obtained from the physical examination when entering the school', 'young women with overweight and obesity population', 'participants were assigned to normal (BMI: 20.98±1.52 kg/m2, n=29), overweight (BMI: 25.57±1.34 kg/m2,n=27), and obesity (BMI: 28.46±2.36 kg/m2,n=25) groups by BMI']","['aerobic exercise training', 'aerobic exercise intervention', 'Regular aerobic exercise', 'yoga combined with aerobic exercise training', 'yoga combined with exercise', 'Yoga combined with aerobic exercise training program', 'aerobic exercise', 'yoga combined with aerobic exercise intervention']","['hip, body weight, BMIand body fat percentage', 'body weight, body height, waist circumference, hip circumference, etc. and blood lipid indicators such as low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC) and triglyceride (TG', 'LDL-C, TC/HDL-C, TG/HDL-C and LDL-C/HDL-C', 'TC and TG significantly decreased in obesity group; and 4) TC/HDL-C and TG/HDL-C', 'morphology and blood lipids', 'hip circumference and waist-to-hip ratio (WHR', 'TC and TG', 'weight loss and decreased body fat percentage', 'morphological and blood lipid indicators', 'BMI', ' 2) waist circumference']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0005890', 'cui_str': 'Body Height'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0205682', 'cui_str': 'Waist-Hip Ratio'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",81.0,0.0149319,"After training program, the results indicated that 1) the hip, body weight, BMIand body fat percentage in all three groups significantly decreased; 2) waist circumference in normal and obesity groups had a significant change than that in overweight group, hip circumference and waist-to-hip ratio (WHR) in overweight group were better than those in normal and overweight groups; the decrease in BMI in overweight and obesity groups was significantly greater than that in normal group, and the weight loss and decreased body fat percentage in obesity group were the highest, followed by overweight group, and the smallest in normal group; 3) in all three groups, HDL-C significantly increased, LDL-C, TC/HDL-C, TG/HDL-C and LDL-C/HDL-C significantly decreased, TC and TG significantly decreased in obesity group; and 4) TC/HDL-C and TG/HDL-C in obesity group were significantly higher than those in normal and overweight groups, while change in TC and TG were the highest in obesity group, the second the overweight group, and the lowest in normal group.
","[{'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'College of Physical Education, Southwest University, Chongqing, China - 784682301@qq.com.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': 'Department of Physical Education, Tangshan Normal University, Tangshan, China.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.19.10147-8']
473,31802233,A single paravertebral injection via a needle vs. a catheter for the spreading to multiple intercostal levels: a randomized controlled trial.,"PURPOSE


Thoracic paravertebral block (TPVB) provides a unilateral nerve block at multiple intercostal levels allowing injection of a local anesthetic into paravertebral space (PVS) via a needle or catheter. However, the most effective injection method remains unclear. This study compared the real-time spread of ropivacaine between two paravertebral injection methods using thoracoscopy.
METHODS


Thirty-four patients scheduled for thoracoscopic surgery were randomly allocated into the Needle or Catheter groups, and performed transverse in-plane ultrasound-guided TPVB. The Needle group received 20 ml of 0.5% ropivacaine via a needle placed into the lateral edge of PVS; the Catheter group received the same dose of ropivacaine via a catheter inserted 5 cm into PVS. The primary outcome was the spreading pattern of ropivacaine in each group. The secondary outcome was intraoperative vasopressor requirement after paravertebral injection.
RESULTS


In the Needle group, all cases showed ropivacaine spread to multiple intercostal levels, mainly across the ribs. Contrastingly, the Catheter group showed variable spreading patterns; multiple intercostal levels (n = 10) [across the ribs (n = 4), anterolateral aspect of the vertebral bodies (n = 6)] or unobservable spreading (no change; n = 7) (P = 0.007). Vasopressors were required in two and ten cases in the Needle and Catheter groups, respectively (P = 0.010).
CONCLUSION


Paravertebral injection via a needle typically resulted in spreading to multiple intercostal levels, especially across the ribs on the peripheral side of injection site, whereas injection via a catheter resulted in variable spreading patterns. Therefore, injections via needles are more stable.",2020,"Vasopressors were required in two and ten cases in the Needle and Catheter groups, respectively (P = 0.010).
",['Thirty-four patients scheduled for thoracoscopic surgery'],"['ropivacaine', 'Thoracic paravertebral block (TPVB', '20\xa0ml of 0.5% ropivacaine', 'ropivacaine via a catheter inserted 5\xa0cm into PVS', 'Needle or Catheter groups, and performed transverse in-plane ultrasound-guided TPVB']","['unobservable spreading', 'spreading pattern of ropivacaine', 'anterolateral aspect of the vertebral bodies', 'intraoperative vasopressor requirement after paravertebral injection', 'variable spreading patterns; multiple intercostal levels']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0751551', 'cui_str': 'Surgical Procedures, Thoracoscopic'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0332261', 'cui_str': 'Spread (attribute)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral (qualifier value)'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",34.0,0.036128,"Vasopressors were required in two and ten cases in the Needle and Catheter groups, respectively (P = 0.010).
","[{'ForeName': 'Tasuku', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Shibata', 'Affiliation': 'Department of Surgical Center, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Ban', 'Affiliation': 'Department of Anesthesiology, Tosei General Hospital, Seto, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shitaokoshi', 'Affiliation': 'Department of Anesthesiology, Tosei General Hospital, Seto, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Biostatistics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Matsui', 'Affiliation': 'Department of Biostatistics, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Kimitoshi', 'Initials': 'K', 'LastName': 'Nishiwaki', 'Affiliation': 'Department of Anesthesiology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, 466-8560, Japan. nishi@med.nagoya-u.ac.jp.'}]",Journal of anesthesia,['10.1007/s00540-019-02713-6']
474,32169923,Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness.,"OBJECTIVE


To estimate the effectiveness of standardised self-management kits for children with type 1 diabetes.
DESIGN


Pragmatic trial with randomisation ratio of two intervention: one control. Qualitative process evaluation.
SETTING


11 diabetes clinics in England and Wales.
PARTICIPANTS


Between February 2010 and August 2011, we validly randomised 308 children aged 6-18 years; 201 received the intervention.
INTERVENTION


We designed kits to empower children to achieve glycaemic control, notably by recording blood glucose and titrating insulin. The comparator was usual treatment. OUTCOME MEASURES AT 3 AND 6 MONTHS: Primary: Diabetes Pediatric Quality of Life Inventory (PedsQL). Secondary: HbA1c; General PedsQL; EQ-5D; healthcare resource use.
RESULTS


Of the five Diabetes PedsQL dimensions, Worry showed adjusted scores significantly favouring self-management kits at 3 months (mean child-reported difference =+5.87; Standard error[SE]=2.19; 95% confidence interval [CI]) from +1.57 to +10.18; p=0.008); but Treatment Adherence significantly favoured controls at 6 months (mean child-reported difference=-4.68; SE=1.74; 95%CI from -8.10 to -1.25; p=0.008). Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=-3.20; SE=1.33; 95% CI from -5.73 to -0.67; p=0.020). There was no evidence of change in HbA1c; only 18% of participants in each group achieved recommended levels at 6 months. No serious adverse reactions attributable to the intervention or its absence were reported.Use of kits was poor. Few children or parents associated blood glucose readings with better glycaemic control. The kits, costing £185, alienated many children and parents.
CONCLUSIONS


Standardised kits showed no evidence of benefit, inhibited diabetes self-management and increased worry. Future research should study relationships between children and professionals, and seek new methods of helping children and parents to manage diabetes.
TRIAL REGISTRATION NUMBER


ISRCTN17551624.",2020,Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=-3.20; SE=1.33; 95% CI from -5.73 to -0.67; p=0.020).,"['Of the five Diabetes PedsQL dimensions', 'children with type 1 diabetes', '11 diabetes clinics in England and Wales', 'Between February 2010 and August 2011, we validly randomised 308 children aged 6-18 years; 201 received the intervention']","['standardised self-management kits', 'Standardised self-management kits']","['serious adverse reactions', 'total score', 'change in HbA1c', 'Diabetes Pediatric Quality of Life Inventory (PedsQL', 'blood glucose readings']","[{'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C1690540', 'cui_str': 'Kit'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0034380'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",308.0,0.115808,Intervention children reported significantly worse changes between 3 and 6 months on four of the five Diabetes PedsQL dimensions and on the total score (mean difference=-3.20; SE=1.33; 95% CI from -5.73 to -0.67; p=0.020).,"[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Noyes', 'Affiliation': 'School of Health Sciences, Bangor University, Bangor, UK jane.noyes@bangor.ac.uk.'}, {'ForeName': 'Davina', 'Initials': 'D', 'LastName': 'Allen', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Carter', 'Affiliation': 'School of Journalism, Media and Culture, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Edwards', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rhiannon Tudor', 'Initials': 'RT', 'LastName': 'Edwards', 'Affiliation': 'Centre for Health Economics and Medicines Management Evaluation, School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Russell', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Russell', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Llinos Haf', 'Initials': 'LH', 'LastName': 'Spencer', 'Affiliation': 'Centre for Health Economics and Medicines Management Evaluation, School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Sylvestre', 'Affiliation': 'Manchester Academic Health Science (MAHSC) Clinical Trials Unit, Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Whitaker', 'Affiliation': 'Whitaker Research Limited, Rhos on Sea, North Wales, UK.'}, {'ForeName': 'Seow Tien', 'Initials': 'ST', 'LastName': 'Yeo', 'Affiliation': 'Centre for Health Economics and Medicines Management Evaluation, School of Health Sciences, Bangor University, Bangor, UK.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Gregory', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}]",BMJ open,['10.1136/bmjopen-2019-032163']
475,30642816,Impact of Audits and Multifaceted Intervention on Vaginal Birth After Caesarean: Secondary Analysis of the QUARISMA Trial.,"OBJECTIVES


This study estimated the effect that a multifaceted intervention aiming to improve the quality of obstetrical care and reduce Caesarean section (CS) had on the rate of vaginal birth after Caesarean (VBAC).
METHODS


This is a secondary analysis of the cluster randomized controlled trial Quality of Care, Obstetrics Risk Management, and Mode of Delivery involving (1) audits regarding the indications for CS, (2) provision of feedback to health professionals, and (3) implementation of best practices to reduce CS rates in Quebec. The impact of intervention on VBAC, trial of labour (TOL), and maternal and neonatal morbidity was reported using adjusted odds ratios (ORs) with 95% confidence intervals (CIs).
RESULTS


Out of 105 351 women who delivered during the pre- and postintervention period, 12 493 (11.9%) had a previous CS. We observed no significant impact of the multifaceted intervention on the rates of TOL (adjusted OR 1.22; 95% CI 0.96-1.56, P = 0.11) and VBAC (adjusted OR 1.20; 95% CI 0.97-1.48, P = 0.10) in women with one previous CS. However, the rate of TOL was reduced (adjusted OR 0.38; 95% CI 0.14-0.99) in women with more than one previous CS. The intervention has no influence on maternal and neonatal morbidity.
CONCLUSIONS


A multifaceted intervention including audits, feedback to health professionals, and implementation of best practices did not affect VBAC rates or maternal and neonatal morbidity. Our results pointed out the need for decision-making processand risk management tools specific to women with previous CS.",2019,"However, the rate of TOL was reduced (adjusted OR 0.38; 95% CI 0.14-0.99) in women with more than one previous CS.","['Quebec', '105 351 women who delivered during the pre- and postintervention period, 12 493 (11.9%) had a previous CS', 'women with previous CS']",['Audits and Multifaceted Intervention'],"['VBAC', 'maternal and neonatal morbidity', 'rate of vaginal birth after Caesarean (VBAC', 'rate of TOL', 'VBAC, trial of labour (TOL), and maternal and neonatal morbidity', 'quality of obstetrical care and reduce Caesarean section (CS', 'Vaginal Birth', 'rates of TOL', 'VBAC rates or maternal and neonatal morbidity']","[{'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}]","[{'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205484', 'cui_str': 'Obstetrical (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]",105351.0,0.23592,"However, the rate of TOL was reduced (adjusted OR 0.38; 95% CI 0.14-0.99) in women with more than one previous CS.","[{'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Roberge', 'Affiliation': ""Centre de recherche du CHU de Québec-Université Laval, Québec City, QC; Harris Birthright Research Centre of Fetal Medicine, King's College Hospital, London, United Kingdom.""}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Boutin', 'Affiliation': 'Centre de recherche du CHU de Québec-Université Laval, Québec City, QC.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Bujold', 'Affiliation': 'Centre de recherche du CHU de Québec-Université Laval, Québec City, QC; Department of Obstetrics, Gynecology and Reproduction, Faculty of Medicine, Université Laval, Québec City, QC.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Dubé', 'Affiliation': 'Centre de recherche du CHU de Québec-Université Laval, Québec City, QC.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Blouin', 'Affiliation': 'Centre de recherche du CHU de Québec-Université Laval, Québec City, QC.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Chaillet', 'Affiliation': 'Centre de recherche du CHU de Québec-Université Laval, Québec City, QC; Department of Obstetrics, Gynecology and Reproduction, Faculty of Medicine, Université Laval, Québec City, QC. Electronic address: nils.chaillet@fmed.ulaval.ca.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2018.05.044']
476,32144319,A randomised controlled study shows supplementation of overweight and obese adults with lactobacilli and bifidobacteria reduces bodyweight and improves well-being.,"In an exploratory, block-randomised, parallel, double-blind, single-centre, placebo-controlled superiority study (ISRCTN12562026, funded by Cultech Ltd), 220 Bulgarian participants (30 to 65 years old) with BMI 25-34.9 kg/m 2  received Lab4P probiotic (50 billion/day) or a matched placebo for 6 months. Participants maintained their normal diet and lifestyle. Primary outcomes were changes in body weight, BMI, waist circumference (WC), waist-to-height ratio (WtHR), blood pressure and plasma lipids. Secondary outcomes were changes in plasma C-reactive protein (CRP), the diversity of the faecal microbiota, quality of life (QoL) assessments and the incidence of upper respiratory tract infection (URTI). Significant between group decreases in body weight (1.3 kg, p < 0.0001), BMI (0.045 kg/m 2 , p < 0.0001), WC (0.94 cm, p < 0.0001) and WtHR (0.006, p < 0.0001) were in favour of the probiotic. Stratification identified greater body weight reductions in overweight subjects (1.88%, p < 0.0001) and in females (1.62%, p = 0.0005). Greatest weight losses were among probiotic hypercholesterolaemic participants (-2.5%, p < 0.0001) alongside a significant between group reduction in small dense LDL-cholesterol (0.2 mmol/L, p = 0.0241). Improvements in QoL and the incidence rate ratio of URTI (0.60, p < 0.0001) were recorded for the probiotic group. No adverse events were recorded. Six months supplementation with Lab4P probiotic resulted in significant weight reduction and improved small dense low-density lipoprotein-cholesterol (sdLDL-C) profiles, QoL and URTI incidence outcomes in overweight/obese individuals.",2020,"Improvements in QoL and the incidence rate ratio of URTI (0.60, p < 0.0001) were recorded for the probiotic group.","['220 Bulgarian participants (30 to 65 years old) with BMI 25-34.9\u2009kg/m 2  received', 'overweight and obese adults with']","['Lab4P probiotic (50 billion/day) or a matched placebo', 'lactobacilli and bifidobacteria', 'Lab4P probiotic']","['body weight', 'body weight reductions', 'Greatest weight losses', 'adverse events', 'weight reduction and improved small dense low-density lipoprotein-cholesterol (sdLDL-C) profiles, QoL and URTI incidence outcomes', 'WtHR', 'changes in plasma C-reactive protein (CRP), the diversity of the faecal microbiota, quality of life (QoL) assessments and the incidence of upper respiratory tract infection (URTI', 'BMI', 'QoL and the incidence rate ratio of URTI', 'small dense LDL-cholesterol', 'changes in body weight, BMI, waist circumference (WC), waist-to-height ratio (WtHR), blood pressure and plasma lipids']","[{'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0337798', 'cui_str': 'Bulgarian (ethnic group)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C1821269', 'cui_str': 'Height-Weight Ratio'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}]",220.0,0.245727,"Improvements in QoL and the incidence rate ratio of URTI (0.60, p < 0.0001) were recorded for the probiotic group.","[{'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Michael', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom. darynm@cultech.co.uk.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Jack', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Masetti', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom.'}, {'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'Davies', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Loxley', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kerry-Smith', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Plummer', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Marchesi', 'Affiliation': 'School of Biosciences, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Mullish', 'Affiliation': 'Division of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'J A K', 'Initials': 'JAK', 'LastName': 'McDonald', 'Affiliation': 'MRC Centre for Molecular Bacteriology and Infection, Imperial College London, London, United Kingdom.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Hughes', 'Affiliation': 'Systems Immunity Research Institute, Henry Welcome Building, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Garaiova', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Paduchová', 'Affiliation': 'Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Faculty of Medicine, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Muchová', 'Affiliation': 'Institute of Medical Chemistry, Biochemistry and Clinical Biochemistry, Faculty of Medicine, Comenius University, Bratislava, Slovakia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Good', 'Affiliation': 'School of Psychology, Tower building, Cardiff University, Cardiff, United Kingdom.'}, {'ForeName': 'S F', 'Initials': 'SF', 'LastName': 'Plummer', 'Affiliation': 'Cultech Limited, Unit 2 Christchurch Road, Baglan Industrial Park, Port Talbot, United Kingdom.'}]",Scientific reports,['10.1038/s41598-020-60991-7']
477,31831574,Reducing weight and increasing physical activity in people at high risk of cardiovascular disease: a randomised controlled trial comparing the effectiveness of enhanced motivational interviewing intervention with usual care.,"OBJECTIVE


The epidemic of obesity is contributing to the increasing prevalence of people at high risk of cardiovascular disease (CVD), negating the medical advances in reducing CVD mortality. We compared the clinical and cost-effectiveness of an intensive lifestyle intervention consisting of enhanced motivational interviewing in reducing weight and increasing physical activity for patients at high risk of CVD.
METHODS


A three-arm, single-blind, parallel-group randomised controlled trial was conducted in consenting primary care centres in south London. We recruited patients aged 40-74 years with a QRisk2 score ≥20.0%, which indicates the probability of having a CVD event in the next 10 years. The intervention was enhanced motivational interviewing which included additional behaviour change techniques and was delivered by health trainers in 10 sessions over 1 year, in either group (n=697) or individual (n=523) format. The third arm received usual care (UC; n=522). The primary outcomes were physical activity (mean steps/day) and weight (kg). Secondary outcomes were changes in low-density lipoprotein cholesterol and CVD risk score. We estimated the relative cost-effectiveness of each intervention.
RESULTS


At 24 months, the group and individual interventions were not more effective than UC in increasing physical activity (mean difference=70.05 steps, 95% CI -288.00 to 147.90 and mean difference=7.24 steps, 95% CI -224.01 to 238.50, respectively), reducing weight (mean difference=-0.03 kg, 95% CI -0.49 to 0.44 and mean difference=-0.42 kg, 95% CI -0.93 to 0.09, respectively) or improving any secondary outcomes. The group and individual interventions were not cost-effective at conventional thresholds.
CONCLUSIONS


Enhancing motivational interviewing with additional behaviour change techniques was not effective in reducing weight or increasing physical activity in those at high CVD risk.",2020,"At 24 months, the group and individual interventions were not more effective than UC in increasing physical activity (mean difference=70.05 steps, 95% CI -288.00 to 147.90 and mean difference=7.24 steps, 95% CI -224.01 to 238.50, respectively), reducing weight (mean difference=-0.03 kg, 95% CI -0.49 to 0.44 and mean difference=-0.42 kg, 95% CI -0.93 to 0.09, respectively) or improving any secondary outcomes.","['patients at high risk of CVD', 'patients aged 40-74 years with a QRisk2 score ≥20.0%, which indicates the probability of having a CVD event in the next 10 years', 'people at high risk of cardiovascular disease', 'consenting primary care centres in south London']","['enhanced motivational interviewing which included additional behaviour change techniques and was delivered by health trainers', 'intensive lifestyle intervention consisting of enhanced motivational interviewing', 'enhanced motivational interviewing intervention with usual care']","['physical activity', 'weight or increasing physical activity', 'low-density lipoprotein cholesterol and CVD risk score', 'weight and increasing physical activity', 'physical activity (mean steps/day) and weight (kg', 'Reducing weight and increasing physical activity', 'reducing weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",,0.148609,"At 24 months, the group and individual interventions were not more effective than UC in increasing physical activity (mean difference=70.05 steps, 95% CI -288.00 to 147.90 and mean difference=7.24 steps, 95% CI -224.01 to 238.50, respectively), reducing weight (mean difference=-0.03 kg, 95% CI -0.49 to 0.44 and mean difference=-0.42 kg, 95% CI -0.93 to 0.09, respectively) or improving any secondary outcomes.","[{'ForeName': 'Khalida', 'Initials': 'K', 'LastName': 'Ismail', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK khalida.2.ismail@kcl.ac.uk.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bayley', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Twist', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Kurtis', 'Initials': 'K', 'LastName': 'Stewart', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Ridge', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Britneff', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Greenough', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""School of Population Health and Environmental Sciences, King's College London, London, London, UK.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rundle', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Derek G', 'Initials': 'DG', 'LastName': 'Cook', 'Affiliation': ""Division of Population Health Sciences and Education, University of London St George's Molecular and Clinical Sciences Research Institute, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Whincup', 'Affiliation': ""Division of Population Health Sciences and Education, University of London St George's Molecular and Clinical Sciences Research Institute, London, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Department of Health Services and Population Research, Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Section of Eating Disorders, Institute of Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Winkley', 'Affiliation': ""Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Stahl', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, King's College London, London, UK.""}]",Heart (British Cardiac Society),['10.1136/heartjnl-2019-315656']
478,32188988,"Efficacy and safety of abiraterone acetate plus prednisone in Japanese patients with newly diagnosed, metastatic hormone-naive prostate cancer: final subgroup analysis of LATITUDE, a randomized, double-blind, placebo-controlled, phase 3 study.","BACKGROUND


LATITUDE was a randomized, double-blind, international and phase 3 study of abiraterone acetate plus prednisone in patients with high-risk metastatic hormone-naïve prostate cancer. In the first interim analysis of LATITUDE (clinical cutoff date: 31 October 2016), significant prolongation in overall survival and radiographic progression-free survival (co-primary endpoints) was observed when compared with placebo. The results of the Japanese subgroup analysis of LATITUDE first interim analysis were consistent with those of the overall population. In this study, overall survival and safety results from the final analysis of the Japanese subgroup of the LATITUDE study are presented (clinical cutoff date: 15 August 2018).
METHODS


Abiraterone acetate (1000 mg/day) and prednisone (5 mg/day) were administered orally in the abiraterone acetate plus prednisone group, and matching placebos in the placebo group.
RESULTS


Of the 1199 patients included in LATITUDE, 70 constituted the Japanese subgroup (abiraterone acetate plus prednisone: n = 35, placebo: n = 35). Following a median (range) follow-up of 56.6 (2.5, 64.2) months, the median overall survival was not reached in both the treatment arms of the Japanese subgroup (hazard ratio: 0.61; 95% confidence interval: 0.27-1.42; nominal P = 0.2502). A total of 23 deaths (abiraterone acetate plus prednisone: 9 [25.7%], placebo group: 14 [40.0%]) were reported in Japanese subgroup. Grade 3/4 adverse events were reported in 24 (68.6%) and 9 (25.7%) patients in the abiraterone acetate plus prednisone and placebo groups, respectively.
CONCLUSIONS


In this Japanese subgroup analysis, addition of abiraterone acetate plus prednisone to androgen-deprivation therapy demonstrated favorable efficacy and safety outcomes in patients with newly diagnosed, high-risk metastatic hormone-naïve prostate cancer. Survival benefits observed in the Japanese subgroup first interim analysis were sustained long-term and were consistent with the overall population.",2020,"Grade 3/4 adverse events were reported in 24 (68.6%) and 9 (25.7%) patients in the abiraterone acetate plus prednisone and placebo groups, respectively.
","['Japanese patients with newly diagnosed, metastatic hormone-naive prostate cancer', 'patients with newly diagnosed, high-risk metastatic hormone-naïve prostate cancer', 'group: 14 [40.0%]) were reported in Japanese subgroup', 'patients with high-risk metastatic hormone-naïve prostate cancer', '1199 patients included in LATITUDE']","['placebo', 'Abiraterone acetate', 'abiraterone acetate plus prednisone', 'prednisone', 'Japanese subgroup (abiraterone acetate plus prednisone']","['Survival benefits', 'Efficacy and safety', 'overall survival and radiographic progression-free survival', 'overall survival and safety', 'median overall survival', 'Grade 3/4 adverse events', 'efficacy and safety outcomes']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.702251,"Grade 3/4 adverse events were reported in 24 (68.6%) and 9 (25.7%) patients in the abiraterone acetate plus prednisone and placebo groups, respectively.
","[{'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Urology, Toho University Sakura Medical Center, Chiba, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Shin', 'Affiliation': 'Department of Urology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fukasawa', 'Affiliation': 'Prostate Center and Division of Urology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Katsuyoshi', 'Initials': 'K', 'LastName': 'Hashine', 'Affiliation': 'National Hospital Organization Shikoku Cancer Center, Ehime, Japan.'}, {'ForeName': 'Sumiko', 'Initials': 'S', 'LastName': 'Kitani', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Noriyuki', 'Initials': 'N', 'LastName': 'Ohtake', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Shibayama', 'Affiliation': 'Janssen Pharmaceutical K.K., Tokyo, Japan.'}, {'ForeName': 'Namphuong', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'Janssen Research & Development, Los Angeles, CA, USA.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Mundle', 'Affiliation': 'Janssen Research & Development, Raritan, NJ, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Institut Gustave Roussy, Paris-Sud University, Villejuif, France.'}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Matsubara', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital East, Chiba, Japan.'}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa030']
479,31825704,Outcome in Children With Standard-Risk B-Cell Acute Lymphoblastic Leukemia: Results of Children's Oncology Group Trial AALL0331.,"PURPOSE


Children's Oncology Group (COG) AALL0331 tested whether intensified postinduction therapy that improves survival in children with high-risk B-cell acute lymphoblastic leukemia (ALL) would also improve outcomes for those with standard-risk (SR) ALL.
PATIENTS AND METHODS


AALL0331 enrolled 5,377 patients between 2005 and 2010. All patients received a 3-drug induction with dexamethasone, vincristine, and pegaspargase (PEG) and were then classified as SR low, SR average, or SR high. Patients with SR-average disease were randomly assigned to receive either standard 4-week consolidation (SC) or 8-week intensified augmented Berlin-Frankfurt-Münster (BFM) consolidation (IC). Those with SR-high disease were nonrandomly assigned to the full COG-augmented BFM regimen, including 2 interim maintenance and delayed intensification phases.
RESULTS


The 6-year event-free survival (EFS) rate for all patients enrolled in AALL0331 was 88.96% ± 0.46%, and overall survival (OS) was 95.54% ± 0.31%. For patients with SR-average disease, the 6-year continuous complete remission (CCR) and OS rates for SC versus IC were 87.8% ± 1.3% versus 89.1% ± 1.2% ( P  = .52) and 95.8% ± 0.8% versus 95.2% ± 0.8% ( P  = 1.0), respectively. Those with SR-average disease with end-induction minimal residual disease (MRD) of 0.01% to < 0.1% had an inferior outcome compared with those with lower MRD and no improvement with IC (6-year CCR: SC, 77.5% ± 4.8%; IC, 77.1% ± 4.8%;  P  = .71). At 6 years, the CCR and OS rates among 635 nonrandomly treated patients with SR-high disease were 85.55% ± 1.49% and 92.97% ± 1.08%, respectively.
CONCLUSION


The 6-year OS rate for > 5,000 children with SR ALL enrolled in AALL0331 exceeded 95%. The addition of IC to treatment for patients with SR-average disease did not improve CCR or OS, even in patients with higher MRD, in whom it might have been predicted to provide more value. The EFS and OS rates are excellent for this group of patients with SR ALL, with particularly good outcomes for those with SR-high disease.",2020,"The EFS and OS rates are excellent for this group of patients with SR ALL, with particularly good outcomes for those with SR-high disease.","['Patients with SR-average disease', 'patients with SR-average disease', 'Children With Standard-Risk B-Cell Acute Lymphoblastic Leukemia', ""Children's Oncology Group (COG"", 'children with high-risk B-cell acute lymphoblastic leukemia (ALL', 'AALL0331 enrolled 5,377 patients between 2005 and 2010']","['standard 4-week consolidation (SC) or 8-week intensified augmented Berlin-Frankfurt-Münster (BFM) consolidation (IC', 'AALL0331', 'dexamethasone, vincristine, and pegaspargase (PEG']","['6-year continuous complete remission (CCR) and OS rates', 'overall survival (OS', 'EFS) rate', 'EFS and OS rates', 'CCR and OS rates', '6-year OS rate', 'survival', '6-year event-free survival ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1292769', 'cui_str': 'c-ALL'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0071568', 'cui_str': 'pegaspargase'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",5377.0,0.0346203,"The EFS and OS rates are excellent for this group of patients with SR ALL, with particularly good outcomes for those with SR-high disease.","[{'ForeName': 'Kelly W', 'Initials': 'KW', 'LastName': 'Maloney', 'Affiliation': 'Department of Pediatrics, University of Colorado, Aurora, CO.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine, Public Health and Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Leonard A', 'Initials': 'LA', 'LastName': 'Mattano', 'Affiliation': 'HARP Pharma Consulting, Mystic, CT.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Friedmann', 'Affiliation': 'Department of Pediatrics, Massachusetts General Hospital Cancer Center, Boston, MA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Buckley', 'Affiliation': 'Department of Pathology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Borowitz', 'Affiliation': 'Department of Pathology, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Gastier-Foster', 'Affiliation': ""Department of Pathology and Laboratory Medicine, Nationwide Children's Hospital, Columbus, OH.""}, {'ForeName': 'Nyla A', 'Initials': 'NA', 'LastName': 'Heerema', 'Affiliation': 'Department of Pathology, Wexner Medical Center, Ohio State University, Columbus, OH.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Kadan-Lottick', 'Affiliation': 'Department of Pediatrics, Yale University, New Haven, CT.'}, {'ForeName': 'Mignon L', 'Initials': 'ML', 'LastName': 'Loh', 'Affiliation': ""Department of Pediatrics, Benioff Children's Hospital, San Francisco, CA.""}, {'ForeName': 'Yousif H', 'Initials': 'YH', 'LastName': 'Matloub', 'Affiliation': ""Department of Pediatrics, Rainbow Babies and Children's Hospital, Cleveland, OH.""}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Marshall', 'Affiliation': 'Department of Radiation Oncology, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Stork', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Raetz', 'Affiliation': 'Perlmutter Cancer Center, New York University (NYU) Langone Medical Center, New York, NY.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Wood', 'Affiliation': 'Department of Pathology, University of Washington, Seattle, WA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Perlmutter Cancer Center, New York University (NYU) Langone Medical Center, New York, NY.'}, {'ForeName': 'Naomi J', 'Initials': 'NJ', 'LastName': 'Winick', 'Affiliation': 'Department of Pediatrics, University of Texas (UT) Southwestern, Dallas, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01086']
480,32217612,FDA Approval Summary: Ado-Trastuzumab Emtansine for the Adjuvant Treatment of HER2-positive Early Breast Cancer.,"On May 3, 2019, the FDA granted regular approval to ado-trastuzumab emtansine (KADCYLA), for the adjuvant treatment of patients with HER2-positive early-breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane-based chemotherapy and trastuzumab-based treatment. Approval was based on data from the KATHERINE trial, which randomized patients to receive ado-trastuzumab emtansine or trastuzumab. At 3 years, the event-free rate for invasive disease-free survival in the ado-trastuzumab emtansine arm was 88.3% [95% confidence interval (CI), 85.8-90.7] compared with 77.0% (95% CI, 73.8-80.7) in the trastuzumab arm, (HR, 0.50; 95% CI, 0.39-0.64;  P  < 0.0001). Results from secondary endpoints, subgroup analyses, and sensitivity analyses generally supported the primary efficacy endpoint results. Common adverse reactions (>25% and higher incidence in ado-trastuzumab emtansine arm) with ado-trastuzumab emtansine were fatigue, nausea, increased transaminases, musculoskeletal pain, hemorrhage, thrombocytopenia, headache, peripheral neuropathy, and arthralgia. Ado-trastuzumab emtansine is the first drug approved for the treatment of patients with residual disease after neoadjuvant treatment and surgery. This article summarizes the FDA review and the data supporting the approval of ado-trastuzumab emtansine as a component of treatment for patients with HER2-positive EBC with residual disease.",2020,"At three years, the event free rate for invasive disease free survival in the ado-trastuzumab emtansine arm was 88.3% (95% confidence interval [CI]: 85.8, 90.7) compared to 77.0% (95% CI: 73.8, 80.7) in the trastuzumab arm, (HR=0.50; 95% CI: 0.39, 0.64; p<.0001).","['patients with HER2-positive EBC with residual disease', 'patients with residual disease after neoadjuvant treatment and surgery', 'patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane based chemotherapy and trastuzumab-based treatment', 'HER2-positive early breast cancer']","['trastuzumab emtansine', 'ado-trastuzumab emtansine or trastuzumab']","['fatigue, nausea, increased transaminases, musculoskeletal pain, hemorrhage, thrombocytopenia, headache, peripheral neuropathy, and arthralgia', 'invasive disease free survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",,0.0410225,"At three years, the event free rate for invasive disease free survival in the ado-trastuzumab emtansine arm was 88.3% (95% confidence interval [CI]: 85.8, 90.7) compared to 77.0% (95% CI: 73.8, 80.7) in the trastuzumab arm, (HR=0.50; 95% CI: 0.39, 0.64; p<.0001).","[{'ForeName': 'Suparna', 'Initials': 'S', 'LastName': 'Wedam', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. Suparna.Wedam@fda.hhs.gov.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Fashoyin-Aje', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bloomquist', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Shenghui', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Sridhara', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Goldberg', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Bellinda L', 'Initials': 'BL', 'LastName': 'King-Kallimanis', 'Affiliation': 'Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Theoret', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Ibrahim', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Amiri-Kordestani', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Pazdur', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Beaver', 'Affiliation': 'Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3980']
481,32217780,Cost-effectiveness of positive airway pressure modalities in obesity hypoventilation syndrome with severe obstructive sleep apnoea.,"BACKGROUND


Obesity hypoventilation syndrome (OHS) is treated with either non-invasive ventilation (NIV) or CPAP, but there are no long-term cost-effectiveness studies comparing the two treatment modalities.
OBJECTIVES


We performed a large, multicentre, randomised, open-label controlled study to determine the comparative long-term cost and effectiveness of NIV versus CPAP in patients with OHS with severe obstructive sleep apnoea (OSA) using hospitalisation days as the primary outcome measure.
METHODS


Hospital resource utilisation and within trial costs were evaluated against the difference in effectiveness based on the primary outcome (hospitalisation days/year, transformed and non-transformed in monetary term). Costs and effectiveness were estimated from a log-normal distribution using a Bayesian approach. A secondary analysis by adherence subgroups was performed.
RESULTS


In total, 363 patients were selected, 215 were randomised and 202 were available for the analysis. The median (IQR) follow-up was 3.01 (2.91-3.14) years for NIV group and 3.00 (2.92-3.17) years for CPAP. The mean (SD) Bayesian estimated hospital days was 2.13 (0.73) for CPAP and 1.89 (0.78) for NIV. The mean (SD) Bayesian estimated cost per patient/year in the NIV arm, excluding hospitalisation costs, was €2075.98 (91.6), which was higher than the cost in the CPAP arm of €1219.06 (52.3); mean difference €857.6 (105.5). CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs. Similar findings were observed in the high and low adherence subgroups.
CONCLUSION


CPAP is more cost-effective than NIV; therefore, CPAP should be the preferred treatment for patients with OHS with severe OSA.
TRIAL REGISTRATION NUMBER


NCT01405976.",2020,CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs.,"['363 patients were selected, 215 were randomised and 202 were available for the analysis', 'obesity hypoventilation syndrome with severe obstructive sleep apnoea', 'patients with OHS with severe OSA', 'patients with OHS with severe obstructive sleep apnoea (OSA']","['CPAP', 'non-invasive ventilation (NIV) or CPAP', 'NIV versus CPAP', 'positive airway pressure modalities']","['mean (SD) Bayesian estimated cost per patient/year in the NIV arm, excluding hospitalisation costs', 'Costs and effectiveness', 'hospital stay', 'mean (SD) Bayesian estimated hospital days']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0031880', 'cui_str': 'Obesity Hypoventilation Syndrome'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",363.0,0.132362,CPAP was more cost-effective than NIV (99.5% probability) because longer hospital stay in the CPAP arm was compensated for by its lower costs.,"[{'ForeName': 'Juan F', 'Initials': 'JF', 'LastName': 'Masa', 'Affiliation': 'Respiratory Department, San Pedro de Alcantara Hospital, Caceres, Spain fmasa@separ.es.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Mokhlesi', 'Affiliation': 'Instituto Universitario deInvestigación Biosanitaria de Extremadura (INUBE), Romero, Auxiliadora.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Benítez', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Francisco Javier', 'Initials': 'FJ', 'LastName': 'Gómez de Terreros Caro', 'Affiliation': 'Respiratory Department, San Pedro de Alcantara Hospital, Caceres, Spain.'}, {'ForeName': 'M-Ángeles', 'Initials': 'MÁ', 'LastName': 'Sánchez-Quiroga', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Auxiliadora', 'Initials': 'A', 'LastName': 'Romero', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Candela', 'Initials': 'C', 'LastName': 'Caballero', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Maria Luz', 'Initials': 'ML', 'LastName': 'Alonso-Álvarez', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Estrella', 'Initials': 'E', 'LastName': 'Ordax-Carbajo', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gómez-García', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'González', 'Affiliation': 'Respiratory Department, Valdecilla Hospital, Santander, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'López-Martín', 'Affiliation': 'Respiratory Department, Gregorio Marañon Hospital, Madrid, Spain.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Marin', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Martí', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Trinidad', 'Initials': 'T', 'LastName': 'Díaz-Cambriles', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Eusebi', 'Initials': 'E', 'LastName': 'Chiner', 'Affiliation': 'Respiratory Department, San Juan Hospital, Alicante, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Egea', 'Affiliation': 'Respiratory Department, Gregorio Marañon Hospital, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Barca', 'Affiliation': 'Institut de Recerca Biomédica de LLeida (IRBLLEIDA), Lleida, Spain.'}, {'ForeName': 'Francisco-José', 'Initials': 'FJ', 'LastName': 'Vázquez-Polo', 'Affiliation': 'Department of Quantitative Methods, University of Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Negrín', 'Affiliation': 'Department of Quantitative Methods, University of Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Martel-Escobar', 'Affiliation': 'Department of Quantitative Methods, University of Las Palmas de Gran Canaria, Las Palmas, Spain.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Barbé', 'Affiliation': 'CIBER de enfermedades respiratorias (CIBERES), Madrid, Spain.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Corral-Peñafiel', 'Affiliation': 'Respiratory Department, San Pedro de Alcantara Hospital, Caceres, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thorax,['10.1136/thoraxjnl-2019-213622']
482,32040875,"Atraumatic restorative treatments reduce the need for dental general anaesthesia: a non-inferiority randomized, controlled trial.","BACKGROUND


A dental general anaesthesia (DGA) is commonly undertaken for the management of dental caries in young children. A randomized-controlled trial was undertaken to test the feasibility of using the Atraumatic Restorative Treatment and Hall Technique approaches (ART/HT) to manage the dental treatment of children recommended for a DGA.
METHODS


Consenting children, recommended a DGA for caries management, at the Oral Health Centre of Western Australia were randomized. Test group children were treated using the ART/HT approach and the control group under a DGA. Children were examined after 12 months by two blinded, calibrated examiners. Analysis was on an intention to treat basis; between and within group comparisons were undertaken using appropriate paired and unpaired tests. Logistic regression was used to test restorative success, controlling for clustering of teeth.
RESULTS


Sixty-five children participated, (Test = 32; Control = 33). At study termination, 28 children (88%) in the ART/HT group and 20 children (61%) in the DGA group had been provided with care, P < 0.01. Crown restorations were protective of restorative failure in a multivariate logistic model (OR 0.05, P < 0.01).
CONCLUSION


Use of the ART/HT approach enabled timely dental treatment of young children recommended for a DGA, and should be among the treatment options considered.",2020,"Crown restorations were protective of restorative failure in a multivariate logistic model (OR 0.05, p<0.01).
","['Dental General Anaesthesia', 'children recommended for a DGA', 'young children', '28 children (88%) in the ART/HT group and 20 children (61%) in the DGA group had been provided with care, p<0.01', 'Consenting children, recommended a DGA for caries management, at the Oral Health Centre of Western Australia were randomised']","['ART/HT approach and the control group under a DGA', 'dental general anaesthesia (DGA', 'Atraumatic Restorative Treatment and Hall Technique approaches (ART/HT', 'ART/HT approach', 'Atraumatic Restorative Treatments']",[],"[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0029162'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0043128', 'cui_str': 'Western Australia'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2356088', 'cui_str': 'Halls'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]",[],65.0,0.148147,"Crown restorations were protective of restorative failure in a multivariate logistic model (OR 0.05, p<0.01).
","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Arrow', 'Affiliation': 'Dental Health Services, Perth, Western Australia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Forrest', 'Affiliation': 'Dental Health Services, Perth, Western Australia.'}]",Australian dental journal,['10.1111/adj.12749']
483,31007170,"Use of Topical Lidocaine Gel Plus Paracervical Blockade vs. Paracervical Blockade Alone for Pain Management During Manual Vacuum Aspiration: ADouble-Blind, Randomized, Placebo-Controlled Trial.","OBJECTIVE


To evaluate if the use of lidocaine gel applied to the cervix prior to manual vacuum aspiration (MVA) in addition to paracervical blockade is useful in reducing the level of pain associated with the procedure.
METHODS


A total of 88 patients were randomized to receive either 5 mL of lidocaine gel or a placebo applied topically to the cervix 5 minutes prior to paracervical blockade. Both groups received the same drugs for pain control (tramadol hydrochloride, diazepam, and sodium diclofenac). A visual analogue scale (VAS) was used for evaluation of pain intensity at two times: 2 minutes before the blockade (directly after tenaculum clamping of the anterior aspect of the cervix) and after MVA of the uterine cavity.
RESULTS


There was a statistically significant difference in pain intensity between the arms of the study. At the first evaluation time (cervical clamping), VAS pain score for the placebo group (control) was 3.6 (2.1) and that for the lidocaine gel group (case) was 1.2 (1.4) (P < 0.01). At the second evaluation time (after manual vacuum aspiration), VAS pain score perceived by the control group was 5.3 (2.5) and that for the case group was 3.1 (1.9) (P < 0.01). The use of lidocaine gel was not associated with any adverse effects of interest.
CONCLUSION


The use of a topical lidocaine gel plus paracervical blockade was effective in reducing the intensity of pain associated with MVA when compared to paracervical blockade alone.",2019,There was a statistically significant difference in pain intensity between the arms of the study.,['88 patients'],"['lidocaine gel plus paracervical blockade', 'Placebo', 'Paracervical Blockade Alone', 'manual vacuum aspiration (MVA', 'pain control (tramadol hydrochloride, diazepam, and sodium diclofenac', 'Topical Lidocaine Gel Plus Paracervical Blockade vs', 'lidocaine gel', 'lidocaine gel or a placebo applied topically to the cervix 5 minutes prior to paracervical blockade']","['evaluation time (cervical clamping), VAS pain score', 'Pain Management', 'pain intensity', 'intensity of pain associated with MVA', 'visual analogue scale (VAS', 'VAS pain score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C2939181', 'cui_str': 'Motor vehicle traffic accident (event)'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C2350089', 'cui_str': 'tramadol hydrochloride'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C2939181', 'cui_str': 'Motor vehicle traffic accident (event)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",88.0,0.0807924,There was a statistically significant difference in pain intensity between the arms of the study.,"[{'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Veces', 'Affiliation': 'Maternidad del Hospital Santo Tomás, Panamá, Panama.'}, {'ForeName': 'Osvaldo', 'Initials': 'O', 'LastName': 'Reyes', 'Affiliation': 'Maternidad del Hospital Santo Tomás, Panamá, Panama. Electronic address: oreyespanama@yahoo.es.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2018.05.027']
484,32186587,High flow nasal cannula oxygen therapy in patients with asthmatic crisis in the pediatric emergency department.,"INTRODUCTION


There are few conclusive studies on the usefulness of High-Flow Nasal Cannula (HFNC) Oxygen Therapy in patients with asthmatic crises.
OBJECTIVE


To determine the effectiveness of HFNC in chil dren older than 2 years of age that present severe and moderate asthmatic crises that do not respond to initial treatment.
PATIENTS AND METHOD


Open controlled randomized clinical trial of patients with asthma exacerbation in the Pediatric Emergency Department. Infection- and comorbidity-media ted crises were excluded. Subjects were randomized as follows: Group 1 HFNC (n:32) and Group 2 Conventional Oxygen Therapy (n:33). Both groups received the usual pharmacological treatment. The first cut-off point was the decrease of more than 2 points of the PIS after 2 hours of treatment; secondary points were PIS decrease at 6 hours, stay time in the Emergency Room, and PICU admis sion.
RESULTS


The patient's baseline characteristics were similar in both groups. The proportion of subjects with more than two points decrease in the PIS after two hours of treatment in Group 1 was 43.7% CI 95% (28-60) vs. Group 2 48.4%; CI 95% (32-64) p 0.447. The mean stay time was 24.8 ± 12.3 hours in Group 1 vs. 24 ± 14.8 hours in Group 2; CI 95% (7.56-5.96) p 0.37. We did not find differences in the respiratory effort score measurements every 2 hours. No patients were admitted to intensive care.
CONCLUSIONS


The incorporation of HFNC oxygen therapy in the treatment of patients with asthmatic crises in the Pediatric Emergency Department did not show clinical benefits nor did it diminish the stay time.",2019,The mean stay time was 24.8 ± 12.3 hours in Group 1 vs. 24 ± 14.8 hours in Group 2; CI 95% (7.56-5.96) p 0.37.,"['chil dren older than 2 years of age that present severe and moderate asthmatic crises', 'patients with asthmatic crises', 'patients with asthmatic crisis in the pediatric emergency department', 'patients with asthmatic crises in the Pediatric Emergency Department', 'patients with asthma exacerbation in the Pediatric Emergency Department']","['HFNC', 'HFNC (n:32) and Group 2 Conventional Oxygen Therapy (n:33', 'High-Flow Nasal Cannula (HFNC) Oxygen Therapy', 'High flow nasal cannula oxygen therapy', 'HFNC oxygen therapy', 'usual pharmacological treatment']","['stay time', 'PIS decrease at 6 hours, stay time', 'mean stay time', 'PIS']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0038218', 'cui_str': 'Asthmatic Shock'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]","[{'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0727045,The mean stay time was 24.8 ± 12.3 hours in Group 1 vs. 24 ± 14.8 hours in Group 2; CI 95% (7.56-5.96) p 0.37.,"[{'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Gauto Benítez', 'Affiliation': 'Departamento de Emergencia Pediátrica, Hospital General Pediátrico de Acosta Ñu, Facultad de Medicina, Universidad del Pacífico, Paraguay.'}, {'ForeName': 'Laura Patricia', 'Initials': 'LP', 'LastName': 'Morilla Sanabria', 'Affiliation': 'Departamento de Emergencia Pediátrica, Hospital General Pediátrico de Acosta Ñu, Facultad de Medicina, Universidad del Pacífico, Paraguay.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Pavlicich', 'Affiliation': 'Departamento de Emergencia Pediátrica, Hospital General Pediátrico de Acosta Ñu, Facultad de Medicina, Universidad del Pacífico, Paraguay.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Mesquita', 'Affiliation': 'Departamento de Emergencia Pediátrica, Hospital General Pediátrico de Acosta Ñu, Facultad de Medicina, Universidad del Pacífico, Paraguay.'}]",Revista chilena de pediatria,['10.32641/rchped.v90i6.1145']
485,32043763,"Health-Related Quality of Life in MONARCH 2: Abemaciclib plus Fulvestrant in Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer After Endocrine Therapy.","BACKGROUND


In the phase III MONARCH 2 study (NCT02107703), abemaciclib plus fulvestrant significantly improved progression-free survival (PFS) versus placebo plus fulvestrant in patients with hormone receptor-positive (HR+), HER2-negative advanced breast cancer (ABC). This study assessed patient-reported pain, global health-related quality of life (HRQoL), functioning, and symptoms.
MATERIALS AND METHODS


Abemaciclib or placebo (150 p.o. mg twice daily) plus fulvestrant (500 mg, per label) were randomly assigned (2:1). The modified Brief Pain Inventory, Short Form (mBPI-sf); European Organization for Research and Treatment of Cancer (EORTC) QoL Core 30 (QLQ-C30); and Breast Cancer Questionnaire (QLQ-BR23) assessed outcomes. Data were collected at baseline, cycle 2, every two cycles 3-13, thereafter at every three cycles, and 30 days postdiscontinuation. Longitudinal mixed regression and Cox proportional hazards models assessed postbaseline change and time to sustained deterioration (TTSD) by study arm.
RESULTS


On-treatment HRQoL scores were consistently maintained from baseline and similar between arms. Patients in the abemaciclib arm (n = 446) experienced a 4.9-month delay in pain deterioration (mBPI-sf), compared with the control arm (n = 223), and significantly greater TTSD on the mBPI-sf and analgesic use (hazard ratio, 0.76; 95% CI, 0.59-0.98) and QLQ-C30 pain item (hazard ratio, 0.62; 95% CI, 0.48-0.79). TTSD for functioning and most symptoms significantly favored the abemaciclib arm, including fatigue, nausea and vomiting, and cognitive and social functioning. Only diarrhea significantly favored the control arm (hazard ratio, 1.60; 95% CI, 1.20-2.10).
CONCLUSION


HRQoL was maintained on abemaciclib plus fulvestrant. Alongside superior PFS and manageable safety profile, results support treatment with abemaciclib plus fulvestrant in a population of patients with endocrine-resistant HR+, HER2-negative ABC.
IMPLICATIONS FOR PRACTICE


In MONARCH 2, abemaciclib plus fulvestrant demonstrated superior efficacy and a manageable safety profile for patients with in hormone receptor-positive (HR+), HER2-negative (-) advanced breast cancer (ABC). Impact on health-related quality of life (HRQoL) is important to consider, given the palliative nature of ABC treatment. In this study, abemaciclib plus fulvestrant, compared with placebo plus fulvestrant, significantly delayed sustained deterioration of pain and other patient-reported symptoms (including fatigue, nausea, vomiting), and social and cognitive functioning. Combined with demonstrated clinical benefit and tolerability, the stabilization of patient-reported symptoms and HRQoL further supports abemaciclib plus fulvestrant as a desirable treatment option in endocrine resistant, HR+, HER2- ABC.",2020,"TTSD for functioning and most symptoms significantly favored the abemaciclib arm, including fatigue, nausea and vomiting, and cognitive and social functioning.","['patients with endocrine-resistant HR+, HER2-negative ABC', 'patients with in hormone receptor-positive (HR+), HER2-negative (-) advanced breast cancer (ABC', 'patients with hormone receptor-positive (HR+), HER2-negative advanced breast cancer (ABC', 'Cancer (EORTC', 'Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer']","['fulvestrant', 'TTSD', 'placebo', 'placebo plus fulvestrant', 'abemaciclib plus fulvestrant', 'Fulvestrant']","['HRQoL scores', 'diarrhea', '4.9-month delay in pain deterioration (mBPI-sf', 'pain, global health-related quality of life (HRQoL), functioning, and symptoms', 'HRQoL', 'progression-free survival (PFS', 'fatigue, nausea and vomiting, and cognitive and social functioning', 'QoL Core 30 (QLQ-C30); and Breast Cancer Questionnaire (QLQ-BR23', 'delayed sustained deterioration of pain and other patient-reported symptoms (including fatigue, nausea, vomiting), and social and cognitive functioning', 'QLQ-C30 pain item', 'health-related quality of life (HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3852841', 'cui_str': 'abemaciclib'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.172778,"TTSD for functioning and most symptoms significantly favored the abemaciclib arm, including fatigue, nausea and vomiting, and cognitive and social functioning.","[{'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Kaufman', 'Affiliation': 'University of Vermont Cancer Center, University of Vermont Medical Center, Burlington, Vermont, USA.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Toi', 'Affiliation': 'Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Yonsei Cancer Center, Seoul, Republic of Korea.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Grischke', 'Affiliation': ""Department of Women's Health, University Hospital Tübingen, Tübingen, Germany.""}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Andre', 'Affiliation': 'Eli Lilly and Company, Paris, France.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Stoffregen', 'Affiliation': 'Eli Lilly and Company, Bad Homburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Shekarriz', 'Affiliation': 'Eli Lilly and Company, Bad Homburg, Germany.'}, {'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Price', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Gebra Cuyun', 'Initials': 'GC', 'LastName': 'Carter', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Stanford University School of Medicine, Stanford, California, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0551']
486,30470978,The Effects of the Nurse Navigation Program in Promoting Colorectal Cancer Screening Behaviors: a Randomized Controlled Trial.,"Although screening programs are known and recommended for the early detection of colorectal cancer (CRC), the screening rates for the fecal occult blood test (FOBT) and colonoscopy are very low among adult individuals. Navigation programs, also known as individualized counseling, have recently begun to be used for increasing screening rates. The purpose of this study was to compare the efficacy of the Nurse Navigation Program versus usual care on CRC screening participation and movement in stage of adoption for CRC screening and to examine perceived benefits of and barriers to CRC screening. This study was designed in line with a pre- and posttest two-group methodology. A total of 110 participants (55 nurse-navigated and 55 non-navigated patients) were studied. Data were collected using the following three tools: a sociodemographic information form, the Harvard Colorectal Cancer Risk Assessment Tool, and Instruments to Measure Colorectal Cancer Screening Benefits and Barriers. Following the Nurse Navigation Program, the FOBT (82 and 84%, respectively) and colonoscopy completion rates (15 and 22%, respectively) were significantly higher in the nurse-navigated group than in the non-navigated group at 3 and 6 months follow-up. Following the program, the benefit perceptions of the nurse-navigated group about CRC screening were improved, and their barrier perceptions were reduced. The results showed that the Nurse Navigation Program had significant effects on CRC screening behavior and health-related beliefs concerning CRC screening. Further assessment of the Nurse Navigation Program in different groups should be performed to observe its effects.",2020,The results showed that the Nurse Navigation Program had significant effects on CRC screening behavior and health-related beliefs concerning CRC screening.,"['Colorectal Cancer Screening Behaviors', '110 participants (55 nurse-navigated and 55 non-navigated patients']","['Nurse Navigation Program versus usual care', 'Nurse Navigation Program']","['colonoscopy completion rates', 'CRC screening behavior and health-related beliefs concerning CRC screening']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",110.0,0.0176525,The results showed that the Nurse Navigation Program had significant effects on CRC screening behavior and health-related beliefs concerning CRC screening.,"[{'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Temucin', 'Affiliation': 'Nursing Faculty, Oncology Nursing Department, University of Health Sciences, Istanbul, Turkey. temucinelif@gmail.com.'}, {'ForeName': 'Nursen O', 'Initials': 'NO', 'LastName': 'Nahcivan', 'Affiliation': 'Florence Nightingale Nursing Faculty, Public Health Nursing Department, Istanbul University, Istanbul, Turkey.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1448-z']
487,32402161,Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.,"BACKGROUND


Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis.
METHODS


We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of  Lactobacillus crispatus  CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12.
RESULTS


A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit,  L. crispatus  CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups.
CONCLUSIONS


The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).",2020,"At the 12-week visit,  L. crispatus  CTV-05 was detected in 79% of participants in the Lactin-V group.","['228 women underwent randomization: 152 to the Lactin-V group and 76 to the', 'Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements']","['vaginal metronidazole', 'vaginally administered Lactin-V or placebo', 'Lactobacillus crispatus  CTV-05 (Lactin-V', 'Lactin-V', 'placebo']","['recurrence of bacterial vaginosis', 'risk ratio for recurrence', 'percentage of women who had a recurrence of bacterial vaginosis', 'percentage of participants with local or systemic adverse events', 'Recurrence of Bacterial Vaginosis']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0595096', 'cui_str': 'Metronidazole-containing product in vaginal dose form'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0595096', 'cui_str': 'Metronidazole-containing product in vaginal dose form'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0317614', 'cui_str': 'Lactobacillus crispatus'}, {'cui': 'C0454198', 'cui_str': 'Clinical target volume'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",228.0,0.642452,"At the 12-week visit,  L. crispatus  CTV-05 was detected in 79% of participants in the Lactin-V group.","[{'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Wierzbicki', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Audrey L', 'Initials': 'AL', 'LastName': 'French', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Morris', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Newmann', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Reno', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Green', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Miller', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Powell', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Parks', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Hemmerling', 'Affiliation': 'From the Departments of Obstetrics, Gynecology, and Reproductive Sciences (C.R.C., S.N., A.H.) and Laboratory Medicine (L.G., S. Miller), University of California, San Francisco, San Francisco, the Department of Family Medicine, University of California, San Diego, San Diego (S. Morris), and Osel, Mountain View (T.P.) - all in California; Emmes, Rockville, MD (M.R.W., J.P.); the Department of Medicine, Ruth M. Rothstein CORE Center and Stroger Hospital of Cook County Health, Rush University Medical Center, Chicago (A.L.F.); and the Division of Infectious Diseases, Department of Medicine, Washington University, St. Louis (H.R.).'}]",The New England journal of medicine,['10.1056/NEJMoa1915254']
488,30676196,"Effects of Protein Intake Beyond Habitual Intakes Associated With Resistance Training on Metabolic Syndrome-Related Parameters, Isokinetic Strength, and Body Composition in Older Women.","The objective of this study was to investigate the effects of protein intake beyond habitual intakes associated with resistance training on metabolic syndrome (MetS)-related parameters, isokinetic strength, and body composition in health older women. A total of 30 older women (68.8 ± 4.3 years) participated in this investigation and were assigned to receive 35 g of whey protein or placebo combined with resistance training, over 12-weeks, three times per week. Blood samples, blood pressure, dietary intake, strength, and body composition were assessed before and after the intervention period. Two-way analysis of variance for repeated measures was applied for comparisons. Both groups improved the skeletal muscle mass, muscular strength, waist circumference, triglycerides, high-density lipoprotein, glucose, resistance, reactance, and MetS Z-score risk. However, the improvements in skeletal muscle mass, waist circumference, and MetS Z-score risk were significantly greater in protein group when compared with control group. Moreover, protein group significantly decreased %body fat when compared with control group. Higher protein intake combined with resistance training promoted greater improvements in skeletal muscle mass, %body fat, waist circumference, and MetS Z-score risk in older women.",2019,"Both groups improved the skeletal muscle mass, muscular strength, waist circumference, triglycerides, high-density lipoprotein, glucose, resistance, reactance, and MetS Z-score risk.","['30 older women (68.8\u2009±\u20094.3\xa0years) participated in this investigation and were assigned to receive 35', 'older women', 'health older women', 'Older Women']","['Resistance Training', 'whey protein or placebo combined with resistance training', 'resistance training', 'Protein Intake Beyond Habitual Intakes']","['skeletal muscle mass, muscular strength, waist circumference, triglycerides, high-density lipoprotein, glucose, resistance, reactance, and MetS Z-score risk', 'skeletal muscle mass, waist circumference, and MetS Z-score risk', 'skeletal muscle mass, %body fat, waist circumference, and MetS Z-score risk', 'Blood samples, blood pressure, dietary intake, strength, and body composition', 'Metabolic Syndrome-Related Parameters, Isokinetic Strength, and Body Composition', 'body fat', 'metabolic syndrome (MetS)-related parameters, isokinetic strength, and body composition']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}]","[{'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",30.0,0.0277354,"Both groups improved the skeletal muscle mass, muscular strength, waist circumference, triglycerides, high-density lipoprotein, glucose, resistance, reactance, and MetS Z-score risk.","[{'ForeName': 'Hellen C G', 'Initials': 'HCG', 'LastName': 'Nabuco', 'Affiliation': ''}, {'ForeName': 'Crisieli M', 'Initials': 'CM', 'LastName': 'Tomeleri', 'Affiliation': ''}, {'ForeName': 'Rodrigo R', 'Initials': 'RR', 'LastName': 'Fernandes', 'Affiliation': ''}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Sugihara Junior', 'Affiliation': ''}, {'ForeName': 'Edilaine F', 'Initials': 'EF', 'LastName': 'Cavalcante', 'Affiliation': ''}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Venturini', 'Affiliation': ''}, {'ForeName': 'Décio S', 'Initials': 'DS', 'LastName': 'Barbosa', 'Affiliation': ''}, {'ForeName': 'Analiza M', 'Initials': 'AM', 'LastName': 'Silva', 'Affiliation': ''}, {'ForeName': 'Luís B', 'Initials': 'LB', 'LastName': 'Sardinha', 'Affiliation': ''}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2018-0370']
489,32201143,Concordance Between Expert and Nonexpert Ratings of Condensed Video-Based Trainee Operative Performance Assessment.,"OBJECTIVE


We examined the impact of video editing and rater expertise in surgical resident evaluation on operative performance ratings of surgical trainees.
DESIGN


Randomized independent review of intraoperative video.
SETTING


Operative video was captured at a single, tertiary hospital in Boston, MA.
PARTICIPANTS


Six common general surgery procedures were video recorded of 6 attending-trainee dyads. Full-length and condensed versions (n = 12 videos) were then reviewed by 13 independent surgeon raters (5 evaluation experts, 8 nonexperts) using a crossed design. Trainee performance was rated using the Operative Performance Rating Scale, System for Improving and Measuring Procedural Learning (SIMPL) Performance scale, the Zwisch scale, and ten Cate scale. These ratings were then standardized before being compared using Bayesian mixed models with raters and videos treated as random effects.
RESULTS


Editing had no effect on the Operative Performance Rating Scale Overall Performance (-0.10, p = 0.30), SIMPL Performance (0.13, p = 0.71), Zwisch (-0.12, p = 0.27), and ten Cate scale (-0.13, p = 0.29). Additionally, rater expertise (evaluation expert vs. nonexpert) had no effect on the same scales (-0.16 (p = 0.32), 0.18 (p = 0.74), 0.25 (p = 0.81), and 0.25 (p = 0.17).
CONCLUSIONS


There is little difference in operative performance assessment scores when raters use condensed videos or when raters who are not experts in surgical resident evaluation are used. Future validation studies of operative performance assessment scales may be facilitated by using nonexpert surgeon raters viewing videos condensed using a standardized protocol.",2020,There is little difference in operative performance assessment scores when raters use condensed videos or when raters who are not experts in surgical resident evaluation are used.,[],['intraoperative video'],"['operative performance assessment scores', 'Operative Performance Rating Scale, System for Improving and Measuring Procedural Learning (SIMPL) Performance scale, the Zwisch scale, and ten Cate scale', 'Trainee performance', 'Operative Performance Rating Scale Overall Performance', 'SIMPL Performance', 'Cate scale']",[],"[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4304298', 'cui_str': 'Procedural learning (regime/therapy)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0828753,There is little difference in operative performance assessment scores when raters use condensed videos or when raters who are not experts in surgical resident evaluation are used.,"[{'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Scully', 'Affiliation': ""Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Shanley B', 'Initials': 'SB', 'LastName': 'Deal', 'Affiliation': 'Department of Surgery, Virginia Mason Medical Center, Seattle, Washington.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Clark', 'Affiliation': 'Consulting for Statistics, Computing, and Analytics, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Consulting for Statistics, Computing, and Analytics, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Wnuk', 'Affiliation': 'Center for Surgical Training and Research, Department of Surgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Smink', 'Affiliation': ""Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Fryer', 'Affiliation': 'Department of Surgery, Northwestern Memorial Hospital, Chicago, Illinois.'}, {'ForeName': 'Jordan D', 'Initials': 'JD', 'LastName': 'Bohnen', 'Affiliation': 'Department of Surgery, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Ezra N', 'Initials': 'EN', 'LastName': 'Teitelbaum', 'Affiliation': 'Department of Surgery, Northwestern Memorial Hospital, Chicago, Illinois.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Meyerson', 'Affiliation': 'Department of Surgery, University of Kentucky Medical Center, Lexington, Kentucky.'}, {'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Meier', 'Affiliation': 'Department of Surgery, SUNY Upstate University Hospital, Syracuse, New York.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Gauger', 'Affiliation': 'Center for Surgical Training and Research, Department of Surgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Rishindra M', 'Initials': 'RM', 'LastName': 'Reddy', 'Affiliation': 'Center for Surgical Training and Research, Department of Surgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Kendrick', 'Affiliation': 'University Hospitals Case Western Reserve, Cleveland Ohio; Center for Surgical Training and Research, Department of Surgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stern', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Hughes', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'Chipman', 'Affiliation': 'Department of Surgery, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Jitesh A', 'Initials': 'JA', 'LastName': 'Patel', 'Affiliation': 'Department of Surgery, University of Kentucky Medical Center, Lexington, Kentucky.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Alseidi', 'Affiliation': 'Department of Surgery, Virginia Mason Medical Center, Seattle, Washington.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'George', 'Affiliation': 'Center for Surgical Training and Research, Department of Surgery, University of Michigan, Ann Arbor, Michigan.'}]",Journal of surgical education,['10.1016/j.jsurg.2019.12.016']
490,31303479,Patients beliefs and attitudes towards deprescribing: Can deprescribing success be predicted?,"BACKGROUND


The ability of questionnaires such as the Patients' Attitudes Towards Deprescribing (PATD) or the Beliefs about Medicines Questionnaire (Specific section) (BMQ-Specific) to successfully identify patients who will deprescribe remains unknown.
OBJECTIVE


To determine if screening questionnaires assessing patients' attitudes and beliefs towards medications and deprescribing can predict deprescribing outcomes.
METHODS


This is a post-hoc secondary analysis of the D-PRESCRIBE trial. 489 community-dwelling adults (≥65 years) who were chronic users (≥3 months) of a potentially inappropriate medication were randomized to a pharmacist-led educational intervention or usual care. Association between baseline responses to PATD and BMQ-Specific items and successful deprescribing was calculated. To determine predictive ability of questionnaire items, receiver operating characteristic curves (ROC) were constructed and area under the curve was calculated.
RESULTS


At baseline, 86% of participants (95% confidence interval [CI] 83-89%) indicated a willingness to deprescribe, yet only 41% (95%CI 37-46%) successfully deprescribed. Six items were associated with deprescribing success, however, no PATD or BMQ-Specific item - either independently or in combination - meaningfully distinguished which participants succeeded or failed deprescribing attempts at 6-months (AUC < 0.7).
CONCLUSION


Current tools to assess patient's attitudes and beliefs towards medication use and/or deprescribing have low predictive validity for successful deprescribing.",2020,"At baseline, 86% of participants (95% confidence interval [CI] 83-89%) indicated a willingness to deprescribe, yet only 41% (95%CI 37-46%) successfully deprescribed.","['489 community-dwelling adults (≥65 years) who were chronic users (≥3 months) of a potentially inappropriate medication', ""Patients' Attitudes""]",['pharmacist-led educational intervention or usual care'],[],"[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4042848', 'cui_str': 'Potentially Inappropriate Medications'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",[],489.0,0.109975,"At baseline, 86% of participants (95% confidence interval [CI] 83-89%) indicated a willingness to deprescribe, yet only 41% (95%CI 37-46%) successfully deprescribed.","[{'ForeName': 'Justin P', 'Initials': 'JP', 'LastName': 'Turner', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada; Centre de Recherche, Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada. Electronic address: justin.turner@criugm.qc.ca.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada; Centre de Recherche, Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Yi Zhi', 'Initials': 'YZ', 'LastName': 'Zhang', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Tannenbaum', 'Affiliation': 'Faculty of Pharmacy, Université de Montréal, Montréal, Québec, Canada; Centre de Recherche, Institut Universitaire de Gériatrie de Montréal, Montréal, Québec, Canada; Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2019.07.007']
491,32144336,Randomized Clinical Trial investigating Self-Assembling Peptide P 11 -4 for Treatment of Early Occlusal Caries.,"Non-invasive caries treatment is a major focus in modern dentistry. The present study was designed to evaluate the effectiveness of monomeric self-assembling peptide P 11 -4 (SAP P 11 -4) in combination with fluoride varnish or polymeric self-assembling peptide matrix (SAPM) in treatment of non-cavitated occlusal caries. Ninety children and adolescents were included in this randomized, gold-standard-controlled clinical trial. Test Group 1 received SAP P 11 -4 and twice fluoride varnish at baseline and Day 180, Test Group 2 received SAP P 11 -4 on baseline and twice weekly SAPM (home-application), and Control Group received fluoride varnish on baseline and Day 180. Caries progression was measured by laser fluorescence, Nyvad Caries Activity, ICDAS-II-codes, and investigator assessments. Laser fluorescence changes demonstrated superior results for Test Group 1 and 2, as values decreased compared to an increase for the Control Group (p < 0.0005). ICDAS-II codes at Day 360 showed partial regression for Test Group 1 (6.7%) and Test Group 2 (20.0%) and partial progression for Control Group (23.3%) (p < 0.01). Nyvad Caries Activity yielded superior caries inactivation for Test Groups, compared to Control Group (p = 0.002). This trial showed that SAP P 11 -4, applied either in combination with fluoride varnish or twice weekly SAPM, was a superior treatment for early caries compared to fluoride varnish alone.",2020,"Nyvad Caries Activity yielded superior caries inactivation for Test Groups, compared to Control Group (p = 0.002).","['Ninety children and adolescents', 'non-cavitated occlusal caries', 'Early Occlusal Caries']","['SAP P 11 -4 and twice\xa0fluoride varnish', 'Self-Assembling Peptide P 11 -4', 'fluoride varnish', 'monomeric self-assembling peptide P 11 -4 (SAP P 11 -4) in combination with fluoride varnish or polymeric self-assembling peptide matrix (SAPM', 'SAP P 11 -4 on baseline and twice weekly SAPM (home-application), and Control Group received fluoride varnish']","['Caries progression', 'partial progression', 'laser fluorescence, Nyvad Caries Activity, ICDAS-II-codes, and investigator assessments']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1947917', 'cui_str': 'Occluded (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0069877', 'cui_str': 'P 11 (pharmaceutical)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1099798', 'cui_str': 'peptide P glycosylase'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",90.0,0.0277162,"Nyvad Caries Activity yielded superior caries inactivation for Test Groups, compared to Control Group (p = 0.002).","[{'ForeName': 'Dafina', 'Initials': 'D', 'LastName': 'Doberdoli', 'Affiliation': 'Department of Pediatric Dentistry and Prevention, University Dentistry Clinical Center of Kosovo, Rrethi I spitalit p.n, Pristina, 10000, Kosovo. dafina913@gmail.com.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Bommer', 'Affiliation': 'credentis ag, Dorfstrasse 69, 5210, Windisch, Switzerland.'}, {'ForeName': 'Agim', 'Initials': 'A', 'LastName': 'Begzati', 'Affiliation': 'Department of Pediatric Dentistry and Prevention, University Dentistry Clinical Center of Kosovo, Rrethi I spitalit p.n, Pristina, 10000, Kosovo.'}, {'ForeName': 'Fehim', 'Initials': 'F', 'LastName': 'Haliti', 'Affiliation': 'Department of Pediatric Dentistry and Prevention, University Dentistry Clinical Center of Kosovo, Rrethi I spitalit p.n, Pristina, 10000, Kosovo.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Heinzel-Gutenbrunner', 'Affiliation': 'MH Statistics, 35041, Marburg, Germany.'}, {'ForeName': 'Hrvoje', 'Initials': 'H', 'LastName': 'Juric', 'Affiliation': 'School of Dental Medicine - Department of Pediatric Dentistry and Prevntion, University of Zagreb, Gundulićeva 5, Zagreb, 10000, Croatia.'}]",Scientific reports,['10.1038/s41598-020-60815-8']
492,32035708,Symptoms associated with influenza vaccination and experimental human pneumococcal colonisation of the nasopharynx.,"BACKGROUND


Nasopharyngeal colonisation by S. pneumoniae is a prerequisite for invasive pneumococcal infections. Influenza co-infection leads to increased susceptibility to secondary pneumonia and mortality during influenza epidemics. Increased bacterial load and impaired immune responses to pneumococcus caused by influenza play a role in this increased susceptibility. Using an Experimental Human Challenge Model and influenza vaccines, we examined symptoms experienced by healthy adults during nasal co-infection with S. pneumoniae and live attenuated influenza virus.
METHODS


Randomised, blinded administration of Live Attenuated Influenza Vaccine (LAIV) or Tetravalent Inactivated Influenza Vaccine (TIV) either preceded bacterial inoculation or followed it, separated by a 3-day interval. The presence and density of S. pneumoniae was determined from nasal washes. Participants completed a symptom questionnaire from the first intervention until 6 days post second intervention.
RESULTS


The timing and type of influenza vaccination and presence of S. pneumoniae in the nasopharynx significantly affected symptom reporting. In the study where influenza vaccination preceded bacterial inoculation: nasal symptoms were less common in the LAIV group than the TIV group (OR 0.57, p < 0.01); with colonisation status only affecting the TIV group where more symptoms were reported by colonised participants compared to non-colonised participants following inoculation (n = 12/23 [52.17%] vs n = 13/38 [34.21%], respectively; p < 0.05). In the study where influenza vaccination followed bacterial inoculation: no difference was seen in the symptoms reported between the LAIV and TIV groups following inoculation and subsequent vaccination; and symptoms were unaffected by colonisation status.
CONCLUSION


Symptoms experienced during live viral vaccination and bacterial co-infection in the nasopharynx are directly affected by the precedence of the pathogen acquisition. Symptoms were directly affected by nasal pneumococcal colonisation but only when TIV was given prior to bacterial exposure.",2020,"In the study where influenza vaccination preceded bacterial inoculation: nasal symptoms were less common in the LAIV group than the TIV group (OR 0.57, p < 0.01); with colonisation status only affecting the TIV group where more symptoms were reported by colonised participants compared to non-colonised participants following inoculation (n = 12/23 [52.17%]",['healthy adults during nasal co-infection with S. pneumoniae and live attenuated influenza virus'],['Live Attenuated Influenza Vaccine (LAIV) or Tetravalent Inactivated Influenza Vaccine (TIV'],"['presence and density of S. pneumoniae', 'nasal pneumococcal colonisation', 'symptom questionnaire', 'bacterial inoculation: nasal symptoms']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0275524', 'cui_str': 'Co-infection'}, {'cui': 'C3652556', 'cui_str': 'influenza, live attenuated'}, {'cui': 'C0042776', 'cui_str': 'Virus'}]","[{'cui': 'C3652556', 'cui_str': 'influenza, live attenuated'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0231918', 'cui_str': 'Nasal symptom'}]",,0.0310684,"In the study where influenza vaccination preceded bacterial inoculation: nasal symptoms were less common in the LAIV group than the TIV group (OR 0.57, p < 0.01); with colonisation status only affecting the TIV group where more symptoms were reported by colonised participants compared to non-colonised participants following inoculation (n = 12/23 [52.17%]","[{'ForeName': 'Caz', 'Initials': 'C', 'LastName': 'Hales', 'Affiliation': 'Royal Liverpool and Broadgreen University Hospital Trust, Prescot Street, Liverpool L7 8XP, UK; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK. Electronic address: Caz.hales@lstmed.ac.uk.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Jochems', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Robinson', 'Affiliation': 'Royal Liverpool and Broadgreen University Hospital Trust, Prescot Street, Liverpool L7 8XP, UK; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Solórzano', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Carniel', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Sherin', 'Initials': 'S', 'LastName': 'Pojar', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Reiné', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Esther L', 'Initials': 'EL', 'LastName': 'German', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Elissavet', 'Initials': 'E', 'LastName': 'Nikolaou', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Mitsi', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Angela D', 'Initials': 'AD', 'LastName': 'Hyder-Wright', 'Affiliation': 'Royal Liverpool and Broadgreen University Hospital Trust, Prescot Street, Liverpool L7 8XP, UK; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Adler', 'Affiliation': 'Royal Liverpool and Broadgreen University Hospital Trust, Prescot Street, Liverpool L7 8XP, UK; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Connor', 'Affiliation': 'Royal Liverpool and Broadgreen University Hospital Trust, Prescot Street, Liverpool L7 8XP, UK; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Seher', 'Initials': 'S', 'LastName': 'Zaidi', 'Affiliation': 'Royal Liverpool and Broadgreen University Hospital Trust, Prescot Street, Liverpool L7 8XP, UK; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Lowe', 'Affiliation': 'Royal Liverpool and Broadgreen University Hospital Trust, Prescot Street, Liverpool L7 8XP, UK; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Gordon', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Rylance', 'Affiliation': 'Royal Liverpool and Broadgreen University Hospital Trust, Prescot Street, Liverpool L7 8XP, UK; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}, {'ForeName': 'Daniela M', 'Initials': 'DM', 'LastName': 'Ferreira', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool L3 5QA, UK.'}]",Vaccine,['10.1016/j.vaccine.2020.01.070']
493,32186238,Effectiveness of elevated vacuum and suction prosthetic suspension systems in managing daily residual limb fluid volume change in people with transtibial amputation.,"BACKGROUND


Previous studies investigating limb volume change with elevated vacuum have shown inconsistent results and have been limited by out-of-socket volume measurements and short, single-activity protocols.
OBJECTIVES


To evaluate the effectiveness of elevated vacuum for managing limb fluid volume compared to suction suspension with an in-socket measurement modality during many hours of activity.
STUDY DESIGN


Fixed-order crossover design with a standardized out-of-laboratory activity protocol.
METHODS


Transtibial electronic elevated vacuum users participated in two sessions. Elevated vacuum was used during the first session, and suction suspension in the second. Participants completed a 5.5-h protocol consisting of multiple intervals of activity. In-socket residual limb fluid volume was continuously measured using a custom portable bioimpedance analyzer.
RESULTS


A total of 12 individuals participated. Overall rate of fluid volume change was not significantly different, though the rate of posterior fluid volume change during Cycle 3 was significantly lower with elevated vacuum. Although individual results varied, 11 participants experienced lower overall rates of fluid volume loss in at least one limb region using elevated vacuum.
CONCLUSION


Elevated vacuum may be more effective as a volume management strategy after accumulation of activity. Individual variation suggests the potential to optimize the limb fluid volume benefits of elevated vacuum by reducing socket vacuum pressure for some users.
CLINICAL RELEVANCE


A better understanding of how elevated vacuum (EV) affects residual limb fluid volume will allow prosthetists to make more informed clinical decisions regarding accommodation strategies designed to improve daily socket fit.",2020,"Overall rate of fluid volume change was not significantly different, though the rate of posterior fluid volume change during Cycle 3 was significantly lower with elevated vacuum.","['people with transtibial amputation', '12 individuals participated', 'Transtibial electronic elevated vacuum users participated in two sessions']","['elevated vacuum and suction prosthetic suspension systems', 'suction suspension']","['socket vacuum pressure', 'overall rates of fluid volume loss', 'Overall rate of fluid volume change']","[{'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0038638', 'cui_str': 'Aspiration, Mechanical'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",12.0,0.198244,"Overall rate of fluid volume change was not significantly different, though the rate of posterior fluid volume change during Cycle 3 was significantly lower with elevated vacuum.","[{'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Youngblood', 'Affiliation': 'Department of Bioengineering, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Brzostowski', 'Affiliation': 'Department of Bioengineering, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Hafner', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Czerniecki', 'Affiliation': 'VA Center for Limb Loss and Mobility, VA Puget Sound Health Care System, Seattle, WA, USA.'}, {'ForeName': 'Katheryn J', 'Initials': 'KJ', 'LastName': 'Allyn', 'Affiliation': 'Department of Bioengineering, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Foster', 'Affiliation': 'TGG Prosthetics & Orthotics, Edmond, OK, USA.'}, {'ForeName': 'Joan E', 'Initials': 'JE', 'LastName': 'Sanders', 'Affiliation': 'Department of Bioengineering, University of Washington, Seattle, WA, USA.'}]",Prosthetics and orthotics international,['10.1177/0309364620909044']
494,31274007,Effect of counseling on maternal-fetal attachment in women with unplanned pregnancy: a randomized controlled trial.,"Introduction : Since the maternal-fetal attachment level in unplanned pregnancies is weaker than their planned counterparts, this study aimed to determine the effect of counselling on maternal-fetal attachment in women with unplanned pregnancy. Methods : This was a randomised controlled clinical trial on pregnant women with unplanned pregnancy and weak-average maternal-fetal attachment scores. Participants were assigned to a control (n = 40) and an intervention (n = 40) group through randomised blocking. The intervention group attended 1-3 individual and 6 group counselling sessions and the control group received routine care. The participants completed the Maternal-Fetal Attachment Scale before and four weeks after the intervention. Results : The mean (standard deviation) maternal-fetal attachment score of the intervention group was increased from 73.6 (8.9) before the intervention to 96.6 (9.3) after the intervention. However, the mean (standard deviation) maternal-fetal attachment scores of the control group were 76.0 (9.4) and 76.5 (6.4) before and after the intervention, respectively. The mean maternal-fetal attachment score of the counselling group was significantly higher than that of the control group (adjusted mean difference: 21.7; 95% confidence interval: 18.6 to 24.9; P < 0.001). Conclusion : Counseling has a positive contribution to improving maternal-fetal attachment in women with unplanned pregnancies.",2020,The mean maternal-fetal attachment score of the counselling group was significantly higher than that of the control group (adjusted mean difference: 21.7; 95% confidence interval: 18.6 to 24.9; P < 0.001).  ,"['women with unplanned pregnancy', 'pregnant women with unplanned pregnancy and weak-average maternal-fetal attachment scores', 'women with unplanned pregnancies']",['intervention group attended 1-3 individual and 6 group counselling sessions and the control group received routine care'],"['mean (standard deviation) maternal-fetal attachment scores', 'mean maternal-fetal attachment score', 'Maternal-Fetal Attachment Scale', 'maternal-fetal attachment', 'mean (standard deviation) maternal-fetal attachment score']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0041747', 'cui_str': 'Unintended Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0237547', 'cui_str': 'Group counseling (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}]",,0.133403,The mean maternal-fetal attachment score of the counselling group was significantly higher than that of the control group (adjusted mean difference: 21.7; 95% confidence interval: 18.6 to 24.9; P < 0.001).  ,"[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ekrami', 'Affiliation': ""Students' Research Committee, Nursing and Midwifery Faculty, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Mohammad-Alizadeh Charandabi', 'Affiliation': 'Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Babapour Kheiroddin', 'Affiliation': 'Department of Psychology, faculty of Psychology and Educational Sciences, University of Tabriz, Tabriz, Iran.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mirghafourvand', 'Affiliation': 'Social Determinants of Health Research Centre, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Journal of reproductive and infant psychology,['10.1080/02646838.2019.1636943']
495,31479004,The Effect of Exercise Timing on Glycemic Control: A Randomized Clinical Trial.,"Despite the acknowledgment of exercise as a cornerstone in the management of type 2 diabetes (T2D), the importance of exercise timing has only recently been considered.
PURPOSE


This study sought to determine the effect of diurnal exercise timing on glycemic control in individuals enrolled in a 12-wk supervised multimodal exercise training program. A secondary aim was to determine the effect of diurnal exercise timing on the circadian rhythm of wrist skin temperature.
METHODS


Forty sedentary, overweight adults (mean ± SD, age = 51 ± 13 yr; body mass index = 30.9 ± 4.2 kg·m; women, n = 23) with and without (n = 20) T2D diagnosis were randomly allocated to either a morning (amEX) or an evening (pmEX) exercise training group. The supervised 12-wk (3 d·wk) program, comprised 30 min of moderate-intensity walking and 4 resistance-based exercises (3 sets, 12-18 repetitions each). Glycemic outcomes (glycated hemoglobin, fasting glucose, postprandial glucose) and wrist skin temperature were assessed at baseline and postintervention.
RESULTS


Exercise training improved (main effect of time, all P < 0.01) all glycemic outcomes; however, this was independent of allocation to either the amEX (Hedge's g, 0.23-0.90) or the pmEX (Hedge's g, 0.16-0.90) group. Accordingly, the adopted exercise training program did not alter the circadian rhythm of skin temperature. When only T2D individuals were compared, amEX demonstrated greater effects (all Hedge's g) on glycated hemoglobin (amEX, 0.57; pmEX, 0.32), fasting glucose (amEX, 0.91; pmEX, 0.53), and postprandial glucose (amEX, 1.12; pmEX, 0.71) but was not statistically different.
CONCLUSIONS


Twelve weeks of multimodal exercise training improved glycemic control and postprandial glycemic responses in overweight non-T2D and T2D individuals. However, no distinct glycemic benefits or alterations in circadian rhythm were associated with morning versus evening exercise, when performed three times per week in this cohort.",2020,"RESULTS


Exercise training improved (main effect of time: all p<0.01) all glycemic outcomes, however, this was independent of allocation to either the amEX (Hedge's g: 0.23-0.90) or pmEX (Hedge's g: 0.16-0.90) group.","['individuals enrolled in a 12-week', 'overweight non-T2D and T2D individuals', 'BMI: 30.9[SD 4.2]kg/m; women: n=23) with and without (n=20', 'Forty sedentary, overweight adults (age: 51[SD 13]years', 'T2D diagnosis']","['Exercise training', 'multi-modal exercise training', 'diurnal exercise', 'supervised multi-modal exercise training program', 'adopted exercise training program', 'moderate intensity walking and 4 resistance-based exercises', 'morning (amEX) or evening (pmEX) exercise training group']","['Glycemic Control', 'HbA1c; fasting glucose, FG; postprandial glucose, PPG) wrist skin temperature', 'circadian rhythm of skin temperature', 'Glycemic outcomes (glycated haemoglobin', 'glycemic outcomes', 'glycemic control and postprandial glycemic responses']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0425382', 'cui_str': 'Adopted (finding)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0049716', 'cui_str': 'thioGDP'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C0008810', 'cui_str': 'Nycthemeral Rhythm'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}]",40.0,0.0416206,"RESULTS


Exercise training improved (main effect of time: all p<0.01) all glycemic outcomes, however, this was independent of allocation to either the amEX (Hedge's g: 0.23-0.90) or pmEX (Hedge's g: 0.16-0.90) group.","[{'ForeName': 'Shaun Y M', 'Initials': 'SYM', 'LastName': 'Teo', 'Affiliation': 'Discipline of Exercise Science, Murdoch University, Perth, AUSTRALIA.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Kanaley', 'Affiliation': 'Faculty of Nutrition and Exercise Physiology, University of Missouri, Columbia, MO.'}, {'ForeName': 'Kym J', 'Initials': 'KJ', 'LastName': 'Guelfi', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), University of Western Australia, Perth, AUSTRALIA.'}, {'ForeName': 'Kieran J', 'Initials': 'KJ', 'LastName': 'Marston', 'Affiliation': 'Discipline of Exercise Science, Murdoch University, Perth, AUSTRALIA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Fairchild', 'Affiliation': 'Discipline of Exercise Science, Murdoch University, Perth, AUSTRALIA.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002139']
496,31574157,"Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Performance of Dura Sealant Patch in Reducing Cerebrospinal Fluid Leakage Following Elective Cranial Surgery: The ENCASE Trial Study Protocol.","BACKGROUND


Cerebrospinal fluid (CSF) leakage is one of the most common neurosurgical complications, occurring in 4% to 32% of surgical cases, with a higher incidence in complicated skull base surgery, intradural spine surgery, and the surgery of the posterior fossa. Our group developed a Dural Sealant Patch (DSP) for watertight dural closure after cranial surgery.
OBJECTIVE


To clinically study for the first time the safety and performance of the DSP as a means of reducing CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.
METHODS


We will conduct an open-label, single-arm, multicenter study with a 360 d (12 mo) follow-up. A total of 40 patients will be enrolled at 3 sites. The primary endpoint is a combination of occurrences of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O, or postoperative wound infection. The secondary endpoints are pseudomeningocele and thickness of dura + DSP.
EXPECTED OUTCOMES


Not more than 3 patients will meet the primary endpoint suggesting safety and efficacy.
DISCUSSION


As a next step, a randomized controlled trial against the best current practice will follow to evaluate if DSP reduces CSF leakage while its safety is noninferior.",2020,"The primary endpoint is a combination of occurrences of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O, or postoperative wound infection.","['40 patients will be enrolled at 3 sites', 'Elective Cranial Surgery', 'patients undergoing elective cranial intradural surgery with a dural closure procedure']","['DSP', 'Dura Sealant Patch', 'Dural Sealant Patch (DSP']","['Cerebrospinal Fluid Leakage', 'combination of occurrences of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O, or postoperative wound infection', 'CSF leakage', 'safety and efficacy', 'pseudomeningocele and thickness of dura\xa0+\xa0DSP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C3163632', 'cui_str': 'Cranial'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C1261530', 'cui_str': 'Sealant (substance)'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}]","[{'cui': 'C0023182', 'cui_str': 'Spinal Cerebrospinal Fluid Leak'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C3177469', 'cui_str': '(pipzH2)(cdo)H2O'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0270687', 'cui_str': 'Spurious meningocele'}]",,0.145799,"The primary endpoint is a combination of occurrences of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O, or postoperative wound infection.","[{'ForeName': 'Tristan P C', 'Initials': 'TPC', 'LastName': 'van Doormaal', 'Affiliation': 'Department of Neurosurgery, Brain Center Rudolph Magnus, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Menno R', 'Initials': 'MR', 'LastName': 'Germans', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Sie', 'Affiliation': 'Department of Neurosurgery, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Brouwers', 'Affiliation': 'Department of Neurosurgery, Brain Center Rudolph Magnus, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Jorn', 'Initials': 'J', 'LastName': 'Fierstra', 'Affiliation': 'Department of Neurosurgery, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Paul R A M', 'Initials': 'PRAM', 'LastName': 'Depauw', 'Affiliation': 'Department of Neurosurgery, Elisabeth-TweeSteden Hospital, Tilburg, The Netherlands.'}, {'ForeName': 'Pierre A', 'Initials': 'PA', 'LastName': 'Robe', 'Affiliation': 'Department of Neurosurgery, Brain Center Rudolph Magnus, University Medical Centre Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Regli', 'Affiliation': 'Brain Technology Institute, Utrecht, The Netherlands.'}]",Neurosurgery,['10.1093/neuros/nyz396']
497,30559087,"Pre-eclampsia Educational Tool Impact on Knowledge, Anxiety, and Satisfaction in Pregnant Women: A Randomized Trial.","OBJECTIVE


This study aimed to evaluate the impact of educational tools concerning pre-eclampsia on knowledge, anxiety, and women's satisfaction.
METHODS


The investigators conducted a randomized controlled trial from March to July 2014 at the Centre Hospitalier Universitaire de Sherbrooke (Sherbrooke, QC) by comparing ambulatory pregnant women (20-32 weeks of gestation) who were receiving educational tools on pre-eclampsia with control patients who received routine care. Tools consisted of an informative pamphlet, a video, and a pictographic magnet, all validated by a multidisciplinary team. The primary outcome was global knowledge (number of correct answers on 35 items) about the disease after 1 month, as assessed by questionnaire. Secondary outcomes included anxiety regarding pre-eclampsia and satisfaction concerning the different tools (a 1-6 Likert scale was used).
RESULTS


Among 362 pregnant women approached for the research, 269 were randomized. After 1 month, 247 questionnaires (92%) were filled and analyzed: 122 from the control group and 125 from the intervention group. Baseline characteristics were similar between the groups. Patients who received the tools scored significantly higher on global knowledge (70.1% ± 19.2% compared with 51.1% ± 23.4%; mean difference of 19.0%; P < 0.001). Anxiety scores regarding pre-eclampsia were similar between the groups, with a mean of 2.40 out of 6 for the control group and 2.53 out of 6 for the intervention group (equivalence test, P < 0.001). High score levels of satisfaction for the pamphlet and video were found: 5.1 out of 6 and 5.2 out of 6, respectively.
CONCLUSION


These well-received educational tools for pregnant women increased their knowledge about pre-eclampsia without increasing their anxiety about it. Women reported the highest satisfaction for the tools.",2019,Patients who received the tools scored significantly higher on global knowledge (70.1% ± 19.2% compared with 51.1% ± 23.4%; mean difference of 19.0%; P < 0.001).,"['Pregnant Women', '362 pregnant women approached for the research, 269 were randomized', 'March to July 2014 at the Centre Hospitalier Universitaire de Sherbrooke (Sherbrooke, QC) by comparing ambulatory pregnant women (20-32 weeks of gestation) who were receiving educational tools on pre-eclampsia with control patients who received routine care']",[],"['global knowledge', 'anxiety regarding pre-eclampsia and satisfaction concerning the different tools (a 1-6 Likert scale was used', 'High score levels of satisfaction', 'Anxiety scores regarding pre-eclampsia', 'Knowledge, Anxiety, and Satisfaction', 'global knowledge (number of correct answers on 35 items) about the disease']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",362.0,0.147045,Patients who received the tools scored significantly higher on global knowledge (70.1% ± 19.2% compared with 51.1% ± 23.4%; mean difference of 19.0%; P < 0.001).,"[{'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Gingras-Charland', 'Affiliation': 'Department of Obstetrics and Gynecology, Centre Hospitalier Universitaire de Sherbrooke, University of Sherbrooke, Sherbrooke, QC.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Côté', 'Affiliation': 'Division of Nephrology, Centre Hospitalier Universitaire de Sherbrooke, University of Sherbrooke, Sherbrooke, QC.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Girard', 'Affiliation': 'Department of Obstetrics and Gynecology, Centre Hospitalier Universitaire de Sherbrooke, University of Sherbrooke, Sherbrooke, QC.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Grenier', 'Affiliation': 'Department of Ergotherapy, University of Sherbrooke, Sherbrooke, QC.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Pasquier', 'Affiliation': 'Department of Obstetrics and Gynecology, Centre Hospitalier Universitaire de Sherbrooke, University of Sherbrooke, Sherbrooke, QC.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Sauvé', 'Affiliation': 'Division of Internal Medicine, Centre Hospitalier Universitaire de Sherbrooke, University of Sherbrooke, Sherbrooke, QC. Electronic address: nadine.sauve@usherbrooke.ca.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2018.10.003']
498,32093451,[Clinical Effect of Day Surgery in Patients with Lung Caner by Optimize Operating Process].,"BACKGROUND


The types and number of day surgery are increasing, what is the result of day surgery of selected patients with lung cancer? To explore the operation process and clinical effect of day surgery in patients with lung cancer by fusing the concept of enhanced recovery after surgery (ERAS) and minimally invasive surgical techniques.
METHODS


A prospective study was planned with the approval of our institutional review board. 153 lung cancer patients who underwent anatomic resection in a single medical group between June 2019 and Nov 2019 were randomized. 20 patients were applied day surgery and 28 patients by inpatient surgery and the average length of stay, average hospital cost , complications and adverse reactions were analysed.
RESULTS


The average hospital day in DSG group (1 d) was significantly shorter than in ISG group (7.7±2.8) d (P=0.000). The average hospital cost in DSG group (38,297.3±3,408.7)¥ was significantly lower than in ISG group (47,831.1±7,376.1)¥ (P=0.000). There was no significant difference in the incidence of postoperative complications between the daytime surgery group (5.0%) and the inpatient surgery group (3.6%) (P=0.812). The postoperation adverse reactions in DSG (10.0%) and ISG (17.9%) is no difference (P=0.72).
CONCLUSIONS


Our study showed that the same clinical effect achieved between DSG and ISG, and recover quickly lung cancer patients after day surgery.",2020,There was no significant difference in the incidence of postoperative complications between the daytime surgery group (5.0%) and the inpatient surgery group (3.6%) (P=0.812).,"['Patients with Lung Caner by Optimize Operating Process', '153 lung cancer patients who underwent anatomic resection in a single medical group between June 2019 and Nov 2019 were randomized', 'patients with lung cancer by fusing the concept of enhanced recovery after surgery (ERAS) and minimally invasive surgical techniques', '20 patients were applied day surgery and 28 patients by inpatient surgery and the']",['Day Surgery'],"['average length of stay, average hospital cost , complications and adverse reactions', 'postoperation adverse reactions', 'incidence of postoperative complications', 'average hospital cost']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0282046', 'cui_str': 'Surgery, Day'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0282046', 'cui_str': 'Surgery, Day'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",153.0,0.0270336,There was no significant difference in the incidence of postoperative complications between the daytime surgery group (5.0%) and the inpatient surgery group (3.6%) (P=0.812).,"[{'ForeName': 'Yingxian', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Daojun', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Guowei', 'Initials': 'G', 'LastName': 'Che', 'Affiliation': 'Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Lunxu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu 610041, China.'}, {'ForeName': 'Hongsheng', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Day Surgery Center, West China Hospital, Sichuan University, Chengdu 610041, China.'}]",Zhongguo fei ai za zhi = Chinese journal of lung cancer,['10.3779/j.issn.1009-3419.2020.02.02']
499,31463874,Removal of DNA-fragmented spermatozoa using flow cytometry and sorting does not improve the outcome of intracytoplasmic sperm injection.,"PURPOSE


The DNA fragmentation in sperm is associated with reduced outcome in assisted reproduction. Using YoPro1 as the staining dye and flow cytometry and sorting (FACS), the number of spermatozoa with DNA fragmentation can be lowered to 5%. Can the cumulative outcome of ICSI be improved using FACS?
METHODS


A prospective, randomized, double-blind clinical trial was conducted in 104 infertile couples with male infertility based on abnormal conventional semen analysis results. Cumulative ongoing pregnancy rate was the primary outcome parameter. In 52 cases, semen was processed for ICSI using swim-up. In another 52 cases, spermatozoa with fragmented DNA were removed with FACS.
RESULTS


The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up. An interim analysis scheduled before initiation of the study after 100 cases demonstrated that the aim of a 20% gain in pregnancy rate could not be achieved. For that reason, the prospective study was stopped prematurely.
CONCLUSIONS


A trend towards consistently better results was achieved by removing spermatozoa with fragmented DNA. The fragmentation of the DNA in sperm is the end stage of apoptosis. Sorting of spermatozoa may be improved by selecting parameters of processes active more upstream of apoptosis, such as chromatin decondensation.
TRIAL REGISTRATION


NCT02166567 . June 14, 2014.",2019,The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up.,['104 infertile couples with male infertility based on abnormal conventional semen analysis results'],[],"['Cumulative ongoing pregnancy rate', 'pregnancy rate', 'cumulative pregnancy rate', 'live birth rate', 'miscarriage rate']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0021364', 'cui_str': 'Male infertility (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",[],"[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}]",,0.368995,The cumulative pregnancy rate at 12 weeks of gestation (51.9% versus 46.2%) and live birth rate (42.3% versus 34.6%) were higher and the miscarriage rate was lower (27.8% versus 35.3%) after FACS-sorting as compared with swim-up.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'De Geyter', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland. christian.degeyter@usb.ch.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Gobrecht-Keller', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Ahler', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Reproductive Medicine and Gynecological Endocrinology (RME), University Hospital, University of Basel, Vogesenstrasse 134, CH-4031, Basel, Switzerland.'}]",Journal of assisted reproduction and genetics,['10.1007/s10815-019-01571-1']
500,32182098,The Effects of a Video Intervention on Posthospitalization Pulmonary Rehabilitation Uptake. A Randomized Controlled Trial.,"Rationale:  Pulmonary rehabilitation (PR) after hospitalizations for exacerbations of chronic obstructive pulmonary disease (COPD) improves exercise capacity and health-related quality of life and reduces readmissions. However, posthospitalization PR uptake is low. To date, no trials of interventions to increase uptake have been conducted. Objectives:  To study the effect of a codesigned education video as an adjunct to usual care on posthospitalization PR uptake. Methods:  The present study was an assessor- and statistician-blinded randomized controlled trial with nested, qualitative interviews of participants in the intervention group. Participants hospitalized with COPD exacerbations were assigned 1:1 to receive either usual care (COPD discharge bundle including PR information leaflet) or usual care plus the codesigned education video delivered via a handheld tablet device at discharge. Randomization used minimization to balance age, sex, FEV 1  % predicted, frailty, transport availability, and previous PR experience. Measurements and Main Results:  The primary outcome was PR uptake within 28 days of hospital discharge. A total of 200 patients were recruited, and 196 were randomized (51% female, median FEV 1%  predicted, 36 [interquartile range, 27-48]). PR uptake was 41% and 34% in the usual care and intervention groups, respectively ( P  = 0.37), with no differences in secondary (PR referral and completion) or safety (readmissions and death) endpoints. A total of 6 of the 15 participants interviewed could not recall receiving the video. Conclusions:  A codesigned education video delivered at hospital discharge did not improve posthospitalization PR uptake, referral, or completion.",2020,"A co-designed education video delivered at hospital discharge did not improve post-hospitalization pulmonary rehabilitation uptake, referral or completion.","['participants in the intervention group', 'Six of the fifteen participants interviewed could not recall receiving the video', 'Pulmonary rehabilitation following hospitalizations for exacerbations of chronic obstructive pulmonary disease (COPD', '200 patients were recruited with 196 randomized (51% female, median (interquartile range', 'Post-Hospitalization Pulmonary Rehabilitation Uptake', 'Participants hospitalized with COPD exacerbations']","['usual care (COPD discharge bundle including pulmonary rehabilitation information leaflet) or usual care plus the co-designed education video delivered via a handheld tablet device at discharge', 'co-designed education video', 'Video Intervention']","['Pulmonary rehabilitation uptake', 'pulmonary rehabilitation uptake within 28 days of hospital discharge', 'secondary (pulmonary rehabilitation referral and completion) or safety (readmissions and death) endpoints']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",200.0,0.195828,"A co-designed education video delivered at hospital discharge did not improve post-hospitalization pulmonary rehabilitation uptake, referral or completion.","[{'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Barker', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Jones', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Winston', 'Initials': 'W', 'LastName': 'Banya', 'Affiliation': 'Medical Statistics, Research & Development, Royal Brompton and Harefield National Health Service (NHS) Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Fleming', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Samantha S C', 'Initials': 'SSC', 'LastName': 'Kon', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Stuart F', 'Initials': 'SF', 'LastName': 'Clarke', 'Affiliation': 'Hillingdon Integrated Respiratory Service, the Hillingdon Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Claire M', 'Initials': 'CM', 'LastName': 'Nolan', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Suhani', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Walsh', 'Affiliation': 'Harefield Respiratory Research Group and.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Maddocks', 'Affiliation': ""Cicely Saunders Institute of Palliative Care, Policy, and Rehabilitation, King's College London, London, United Kingdom; and.""}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'Farquhar', 'Affiliation': 'School of Health Sciences, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Bell', 'Affiliation': 'National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care Northwest London, Imperial College, London, United Kingdom.'}, {'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'National Heart and Lung Institute and.'}, {'ForeName': 'William D-C', 'Initials': 'WD', 'LastName': 'Man', 'Affiliation': 'Harefield Respiratory Research Group and.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201909-1878OC']
501,32157099,Acute increases in brain-derived neurotrophic factor in plasma following physical exercise relates to subsequent learning in older adults.,"Multidomain lifestyle interventions represents a promising strategy to counteract cognitive decline in older age. Brain-derived neurotrophic factor (BDNF) is essential for experience-dependent plasticity and increases following physical exercise, suggesting that physical exercise may facilitate subsequent learning. In a randomized-controlled trial, healthy older adults (65-75 years) completed a 12-week behavioral intervention that involved either physical exercise immediately before cognitive training (n = 25; 13 females), physical exercise immediately after cognitive training (n = 24; 11 females), physical exercise only (n = 27; 15 females), or cognitive training only (n = 21; 12 females). We hypothesized that cognition would benefit more from cognitive training when preceded as opposed to followed by physical exercise and that the relationship between exercise-induced increases in peripheral BDNF and cognitive training outcome would be greater when cognitive training is preceded by physical exercise. Greater increases of plasma BDNF were associated with greater cognitive training gains on trained task paradigms, but only when such increases preceded cognitive training (ß = 0.14, 95% CI [0.04, 0.25]). Average cognitive training outcome did not differ depending on intervention order (ß = 0.05, 95% CI [-0.10, 0.20]). The study provides the first empirical support for a time-critical but advantageous role for post-exercise increases in peripheral BDNF for learning at an interindividual level in older adults, with implications for future multidomain lifestyle interventions.",2020,"Average cognitive training outcome did not differ depending on intervention order (ß = 0.05, 95% CI [-0.10, 0.20]).","['older adults', 'healthy older adults (65-75 years', 'older age']","['behavioral intervention that involved either physical exercise immediately before cognitive training', 'physical exercise immediately after cognitive training', 'Multidomain lifestyle interventions', 'Brain-derived neurotrophic factor (BDNF', 'physical exercise only (n\u2009=\u200927; 15 females), or cognitive training']","['plasma BDNF', 'Average cognitive training outcome', 'cognitive training gains', 'cognitive training', 'peripheral BDNF and cognitive training outcome']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}]","[{'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}]",,0.022719,"Average cognitive training outcome did not differ depending on intervention order (ß = 0.05, 95% CI [-0.10, 0.20]).","[{'ForeName': 'Jonna', 'Initials': 'J', 'LastName': 'Nilsson', 'Affiliation': 'Aging Research Center, Karolinska Institutet and Stockholm University, Stockholm, Sweden. jonna.nilsson@ki.se.'}, {'ForeName': 'Örjan', 'Initials': 'Ö', 'LastName': 'Ekblom', 'Affiliation': 'Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ekblom', 'Affiliation': 'Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lebedev', 'Affiliation': 'Aging Research Center, Karolinska Institutet and Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Tarassova', 'Affiliation': 'Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Moberg', 'Affiliation': 'Swedish School of Sport and Health Sciences, Stockholm, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lövdén', 'Affiliation': 'Aging Research Center, Karolinska Institutet and Stockholm University, Stockholm, Sweden.'}]",Scientific reports,['10.1038/s41598-020-60124-0']
502,32127550,Intermittent Lactobacilli-containing Vaginal Probiotic or Metronidazole Use to Prevent Bacterial Vaginosis Recurrence: A Pilot Study Incorporating Microscopy and Sequencing.,"Bacterial vaginosis (BV) is associated with HIV acquisition and adverse pregnancy outcomes. Recurrence after metronidazole treatment is high. HIV-negative, non-pregnant Rwandan BV patients were randomized to four groups (n = 17/group) after seven-day oral metronidazole treatment: behavioral counseling only (control), or counseling plus intermittent use of oral metronidazole, Ecologic Femi+ vaginal capsule (containing multiple Lactobacillus and one Bifidobacterium species), or Gynophilus LP vaginal tablet (L. rhamnosus 35) for two months. Vaginal microbiota assessments at all visits included Gram stain Nugent scoring and 16S rRNA gene qPCR and HiSeq sequencing. All interventions were safe. BV (Nugent 7-10) incidence was 10.18 per person-year at risk in the control group, and lower in the metronidazole (1.41/person-year; p = 0.004), Ecologic Femi+ (3.58/person-year; p = 0.043), and Gynophilus LP groups (5.36/person-year; p = 0.220). In mixed effects models adjusted for hormonal contraception/pregnancy, sexual risk-taking, and age, metronidazole and Ecologic Femi+ users, each compared to controls, had higher Lactobacillus and lower BV-anaerobes estimated concentrations and/or relative abundances, and were less likely to have a dysbiotic vaginal microbiota type by sequencing. Inter-individual variability was high and effects disappeared soon after intervention cessation. Lactobacilli-based vaginal probiotics warrant further evaluation because, in contrast to antibiotics, they are not expected to negatively affect gut microbiota or cause antimicrobial resistance.",2020,"BV (Nugent 7-10) incidence was 10.18 per person-year at risk in the control group, and lower in the metronidazole (1.41/person-year; p = 0.004), Ecologic Femi+ (3.58/person-year; p = 0.043), and Gynophilus LP groups (5.36/person-year; p = 0.220).","['HIV-negative, non-pregnant Rwandan BV patients']","['Intermittent Lactobacilli-containing Vaginal Probiotic or Metronidazole', 'metronidazole treatment: behavioral counseling only (control), or counseling plus intermittent use of oral metronidazole, Ecologic Femi+ vaginal capsule (containing multiple Lactobacillus and one Bifidobacterium species), or Gynophilus LP vaginal tablet', 'metronidazole']","['Recurrence', 'Ecologic Femi', 'Vaginal microbiota assessments', 'Bacterial Vaginosis Recurrence', 'Bacterial vaginosis (BV', 'BV']","[{'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling (procedure)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1273011', 'cui_str': 'Vaginal capsule'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0042264', 'cui_str': 'Vaginal Tablet'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}]",,0.0459912,"BV (Nugent 7-10) incidence was 10.18 per person-year at risk in the control group, and lower in the metronidazole (1.41/person-year; p = 0.004), Ecologic Femi+ (3.58/person-year; p = 0.043), and Gynophilus LP groups (5.36/person-year; p = 0.220).","[{'ForeName': 'Janneke H H M', 'Initials': 'JHHM', 'LastName': 'van de Wijgert', 'Affiliation': 'Institute of Infection and Global Health, University of Liverpool, Liverpool, UK. j.vandewijgert@liverpool.ac.uk.'}, {'ForeName': 'Marijn C', 'Initials': 'MC', 'LastName': 'Verwijs', 'Affiliation': 'Institute of Infection and Global Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Agaba', 'Affiliation': 'Rinda Ubuzima, College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bronowski', 'Affiliation': 'Institute of Infection and Global Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Lambert', 'Initials': 'L', 'LastName': 'Mwambarangwe', 'Affiliation': 'Rinda Ubuzima, College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Uwineza', 'Affiliation': 'Rinda Ubuzima, College of Medicine and Health Sciences, University of Rwanda, Kigali, Rwanda.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Lievens', 'Affiliation': 'Winclove Probiotics, Amsterdam, The Netherlands.'}, {'ForeName': 'Adrien', 'Initials': 'A', 'LastName': 'Nivoliez', 'Affiliation': 'Biose, Arpajon-sur-Cère, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Ravel', 'Affiliation': 'Institute of Genome Sciences, University of Maryland, Baltimore, USA.'}, {'ForeName': 'Alistair C', 'Initials': 'AC', 'LastName': 'Darby', 'Affiliation': 'Centre for Genomic Research, Institute of Integrative Biology, University of Liverpool, Liverpool, UK.'}]",Scientific reports,['10.1038/s41598-020-60671-6']
503,31462727,"The effects of soursop supplementation on blood pressure, serum uric acid, and kidney function in a prehypertensive population in accordance with the 2017 ACC/AHA guideline.","Soursop consumption is beneficial to health, but there have been few clinical studies observing its benefit in human subjects. We investigated the effects of soursop supplementation on blood pressure (BP), serum uric acid (SUA), and kidney function. A total of 143 subjects were included in this randomized controlled trial. Subjects were selected from a prehypertension population dataset (n = 4190) in the ""Mlati Study Database"" in 2007 (using the Joint National Committee (JNC) 7 guideline). After 10 years, 143 samples showed essential prehypertension combined with high-normal SUA levels. Subjects were randomly allocated into two groups, i.e., the treatment and control group. For a 3-month period, the treatment group was given 2 × 100 g soursop fruit juice per day and the control group was not treated. Using the JNC 7 guideline, the treatment group showed a significantly lower mean systolic BP after being adjusted by three times of examinations (baseline, week 6 and 12) compared with the control group. Furthermore, the control group was more likely to have prehypertension, hypertension, and high-normal and high SUA levels after 6 weeks, as well as after 12 weeks, compared with the treatment group. An additional analysis using the 2017 ACC/AHA guideline for subjects with stage 1 hypertension showed results similar to that using the JNC 7 guideline. Moreover, it indicated that mean of both systolic and diastolic BP of the treatment group was significantly lower compared with the control group after 12 weeks of treatment. We conclude that soursop supplementation can lower BP and SUA levels.",2020,"Moreover, it indicated that mean of both systolic and diastolic BP of the treatment group was significantly lower compared with the control group after 12 weeks of treatment.","['human subjects', 'Subjects were selected from a prehypertension population dataset (n\u2009=\u20094190) in the ""Mlati Study Database"" in 2007 (using the Joint National Committee (JNC) 7 guideline', 'subjects with stage 1 hypertension', 'prehypertensive population in accordance with the 2017 ACC/AHA guideline', 'A total of 143 subjects']",['soursop supplementation'],"['blood pressure, serum uric acid, and kidney function', 'prehypertension, hypertension, and high-normal and high SUA levels', 'mean of both systolic and diastolic BP', 'blood pressure (BP), serum uric acid (SUA), and kidney function', 'mean systolic BP', 'BP and SUA levels', 'essential prehypertension combined with high-normal SUA levels']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C1696708', 'cui_str': 'Pre-Hypertension'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}]","[{'cui': 'C3853347', 'cui_str': 'Annona muricata fruit'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1696708', 'cui_str': 'Pre-Hypertension'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205224', 'cui_str': 'Essential (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]",143.0,0.0182731,"Moreover, it indicated that mean of both systolic and diastolic BP of the treatment group was significantly lower compared with the control group after 12 weeks of treatment.","[{'ForeName': 'Haidar', 'Initials': 'H', 'LastName': 'Alatas', 'Affiliation': 'Mlati Study Group, Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Mochammad', 'Initials': 'M', 'LastName': ""Sja'bani"", 'Affiliation': 'Mlati Study Group, Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia. msbani_jogja@yahoo.com.'}, {'ForeName': 'Mustofa', 'Initials': 'M', 'LastName': 'Mustofa', 'Affiliation': 'Mlati Study Group, Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Ali Ghufron', 'Initials': 'AG', 'LastName': 'Mukti', 'Affiliation': 'Mlati Study Group, Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Lucky A', 'Initials': 'LA', 'LastName': 'Bawazier', 'Affiliation': 'Mlati Study Group, Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Fredie', 'Initials': 'F', 'LastName': 'Irijanto', 'Affiliation': 'Mlati Study Group, Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Zulaela', 'Initials': 'Z', 'LastName': 'Zulaela', 'Affiliation': 'Mlati Study Group, Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Tomino', 'Affiliation': 'Medical Corporation SHOWAKAI, Tokyo, Japan.'}]",Journal of human hypertension,['10.1038/s41371-019-0235-6']
504,32065827,Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial.,"Importance


Intraoperative hypotension is associated with increased morbidity and mortality. A machine learning-derived early warning system to predict hypotension shortly before it occurs has been developed and validated.
Objective


To test whether the clinical application of the early warning system in combination with a hemodynamic diagnostic guidance and treatment protocol reduces intraoperative hypotension.
Design, Setting, and Participants


Preliminary unblinded randomized clinical trial performed in a tertiary center in Amsterdam, the Netherlands, among adult patients scheduled for elective noncardiac surgery under general anesthesia and an indication for continuous invasive blood pressure monitoring, who were enrolled between May 2018 and March 2019. Hypotension was defined as a mean arterial pressure (MAP) below 65 mm Hg for at least 1 minute.
Interventions


Patients were randomly assigned to receive either the early warning system (n = 34) or standard care (n = 34), with a goal MAP of at least 65 mm Hg in both groups.
Main Outcomes and Measures


The primary outcome was time-weighted average of hypotension during surgery, with a unit of measure of millimeters of mercury. This was calculated as the depth of hypotension below a MAP of 65 mm Hg (in millimeters of mercury) × time spent below a MAP of 65 mm Hg (in minutes) divided by total duration of operation (in minutes).
Results


Among 68 randomized patients, 60 (88%) completed the trial (median age, 64 [interquartile range {IQR}, 57-70] years; 26 [43%] women). The median length of surgery was 256 minutes (IQR, 213-430 minutes). The median time-weighted average of hypotension was 0.10 mm Hg (IQR, 0.01-0.43 mm Hg) in the intervention group vs 0.44 mm Hg (IQR, 0.23-0.72 mm Hg) in the control group, for a median difference of 0.38 mm Hg (95% CI, 0.14-0.43 mm Hg; P = .001). The median time of hypotension per patient was 8.0 minutes (IQR, 1.33-26.00 minutes) in the intervention group vs 32.7 minutes (IQR, 11.5-59.7 minutes) in the control group, for a median difference of 16.7 minutes (95% CI, 7.7-31.0 minutes; P < .001). In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.
Conclusions and Relevance


In this single-center preliminary study of patients undergoing elective noncardiac surgery, the use of a machine learning-derived early warning system compared with standard care resulted in less intraoperative hypotension. Further research with larger study populations in diverse settings is needed to understand the effect on additional patient outcomes and to fully assess safety and generalizability.
Trial Registration


ClinicalTrials.gov Identifier: NCT03376347.",2020,"In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.
","['adult patients scheduled for elective noncardiac surgery under general anesthesia and an indication for continuous invasive blood pressure monitoring, who were enrolled between May 2018 and March 2019', 'During Elective Noncardiac Surgery', '68 randomized patients, 60 (88%) completed the trial (median age, 64 [interquartile range {IQR}, 57-70] years; 26 [43%] women', 'patients undergoing elective noncardiac surgery']","['early warning system (n\u2009=\u200934) or standard care', 'Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care', 'machine learning-derived early warning system compared with standard care']","['median time of hypotension', 'mean arterial pressure (MAP', 'intraoperative hypotension', 'time-weighted average of hypotension during surgery, with a unit of measure of millimeters of mercury', 'median length of surgery', 'Hypotension', 'median time-weighted average of hypotension', '0 serious adverse events resulting in death', 'morbidity and mortality', 'Depth and Duration of Intraoperative Hypotension']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1270999', 'cui_str': 'Invasive blood pressure (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0336779', 'cui_str': 'Machine, device (physical object)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C1112259', 'cui_str': 'Intraoperative hypotension'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C4517362', 'cui_str': 'Hypotension during surgery (disorder)'}, {'cui': 'C1519795', 'cui_str': 'Unit of measure (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",68.0,0.308548,"In the intervention group, 0 serious adverse events resulting in death occurred vs 2 (7%) in the control group.
","[{'ForeName': 'Marije', 'Initials': 'M', 'LastName': 'Wijnberge', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Bart F', 'Initials': 'BF', 'LastName': 'Geerts', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Liselotte', 'Initials': 'L', 'LastName': 'Hol', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Lemmers', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Marijn P', 'Initials': 'MP', 'LastName': 'Mulder', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Berge', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Schenk', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Lotte E', 'Initials': 'LE', 'LastName': 'Terwindt', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Hollmann', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Vlaar', 'Affiliation': 'Department of Intensive Care, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Denise P', 'Initials': 'DP', 'LastName': 'Veelo', 'Affiliation': 'Department of Anesthesiology, Amsterdam UMC, Location AMC, Amsterdam, the Netherlands.'}]",JAMA,['10.1001/jama.2020.0592']
505,32061707,Influence of front-of-pack labelling and regulated nutrition claims on consumers' perceptions of product healthfulness and purchase intentions: A randomized controlled trial.,"Mandatory front-of-pack (FOP) labelling was proposed in Canada to highlight foods with high contents of sugars, sodium and/or saturated fats, which would be displayed on labels along with the mandatory Nutrition Facts table and voluntary nutrition claims. In an online survey, participants (n = 1997) were randomized to one of four FOP labelling conditions: 1) control, 2) warning label, 3) health star rating or 4) traffic light labelling. Participants were shown four drinks (a healthier drink with or without a disease risk reduction claim, a healthier drink with or without a nutrient content claim, a less healthy drink with or without a disease risk reduction claim and a less healthy drink with or without a nutrient content claim) in random order and one at a time. Participants rated perceived product healthfulness and purchase intentions using a 7-point Likert scale. Participants could access the Nutrition Facts table while viewing labels. Results showed less healthy drinks displaying any FOP labelling were perceived as less healthy compared to the control. In healthier drinks, health star rating and traffic light labelling created a 'halo' effect, which was not observed with warning labels. Similar results were observed with purchase intentions. Drinks displaying a disease risk reduction claim were perceived as healthier than those without (p < 0.001) regardless of product's healthfulness. The effect of a nutrient content claim was not significantly different. The effect of FOP labelling and claims was mitigated for those who used the Nutrition Facts table. FOP labelling was likely helpful for consumers with different levels of health literacy. Overall, FOP labelling had significantly stronger influence than nutrition claims on consumers' perceptions; however, the effect of each FOP label varied on healthier and less healthy drinks.",2020,Drinks displaying a disease risk reduction claim were perceived as healthier than those without (p < 0.001) regardless of product's healthfulness.,"['participants (n\xa0=\xa01997', 'Participants were shown four drinks (a healthier drink with or without a disease risk reduction claim, a healthier drink with or without a nutrient content claim, a less healthy drink with or without a disease risk reduction claim and a less healthy drink with or without a nutrient content claim) in random order and one at a time', ""consumers' perceptions of product healthfulness and purchase intentions""]","['FOP labelling', 'front-of-pack labelling and regulated nutrition claims', 'FOP labelling conditions: 1) control, 2) warning label, 3) health star rating or 4) traffic light labelling']",['healthy drinks displaying any FOP labelling'],"[{'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442664', 'cui_str': 'Traffic light (physical object)'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]",1997.0,0.0448937,Drinks displaying a disease risk reduction claim were perceived as healthier than those without (p < 0.001) regardless of product's healthfulness.,"[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Franco-Arellano', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada. Electronic address: beatriz.francoarellano@mail.utoronto.ca.""}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Vanderlee', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada; School of Public Health and Health Systems, University of Waterloo, 200 University Avenue West, Waterloo, Ontario, N2L 3G1, Canada. Electronic address: lana.vanderlee@uwaterloo.ca.""}, {'ForeName': 'Mavra', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada. Electronic address: mavra.ahmed@mail.utoronto.ca.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Oh', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada; Faculty of Law, University of Ottawa, 57 Louis Pasteur St, Ottawa, Ontario, K1N 6N5, Canada. Electronic address: yeonji.oh@mail.utoronto.ca.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""L'Abbé"", 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada. Electronic address: mary.labbe@utoronto.ca.""}]",Appetite,['10.1016/j.appet.2020.104629']
506,30990057,Effectiveness of a psychological intervention focused on stress management for women prior to IVF.,"Objective : To evaluate the effectiveness of a psychological intervention focused on stress management in women who are candidates for in vitro fertilisation (IVF). Method : Pre-post study with two groups ( n  = 26). The psychological intervention group (IG) received a 90-minute session that included psychoeducation, relaxation training and coping skills. The control group (CG) did not receive any psychological intervention. All participants later underwent IVF. In the initial and final evaluations, state anxiety, emotional imbalance, adaptive resources and quality of life were measured. In the initial evaluation, demographic and clinical variables were also measured. Results : In the IG, the final evaluation reflected: (1) decreased levels of anxiety and emotional imbalance; (2) the perception of enhanced quality of life. Moreover, among the participants who received the psychological intervention and later achieved a successful IVF, the level of anxiety appeared to have decreased more strongly. Conclusions : A brief intervention focused on stress management can benefit the psychological adjustment of women who are candidates for IVF, reducing the anxiety they may experience in this regard. However, our conclusions are based on a small sample, and so should be considered with caution. Nevertheless, these results are promising and highlight the advisability of further research.",2020,"A brief intervention focused on stress management can benefit the psychological adjustment of women who are candidates for IVF, reducing the anxiety they may experience in this regard.","['Pre-post study with two groups (n\xa0=\xa026', 'women who are candidates for in vitro fertilisation (IVF', 'women prior to IVF']","['control group (CG) did not receive any psychological intervention', 'psychological intervention group (IG) received a 90-minute session that included psychoeducation, relaxation training and coping skills', 'psychological intervention']","['levels of anxiety and emotional imbalance', 'perception of enhanced quality of life', 'successful IVF, the level of anxiety', 'state anxiety, emotional imbalance, adaptive resources and quality of life']","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034380'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",,0.0232095,"A brief intervention focused on stress management can benefit the psychological adjustment of women who are candidates for IVF, reducing the anxiety they may experience in this regard.","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Heredia', 'Affiliation': 'U. Reproducción, UGC Laboratorio clínico y UGC Obstetricia y Ginecología, HU Virgen de las Nieves, Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Padilla', 'Affiliation': 'Department of Experimental Psychology, Mind, Brain and Behavior Research Center (CIMCYC), University of Granada, Granada, Spain.'}, {'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'Castilla', 'Affiliation': 'U. Reproducción, UGC Laboratorio clínico y UGC Obstetricia y Ginecología, HU Virgen de las Nieves, Instituto de Investigación Biosanitaria ibs.GRANADA, Granada, Spain.'}, {'ForeName': 'Rocio', 'Initials': 'R', 'LastName': 'Garcia-Retamero', 'Affiliation': 'Department of Experimental Psychology, Mind, Brain and Behavior Research Center (CIMCYC), University of Granada, Granada, Spain.'}]",Journal of reproductive and infant psychology,['10.1080/02646838.2019.1601170']
507,31418607,Effects of Messaging and Psychological Reactance on Marijuana Craving.,"Background : Psychological Reactance Theory asserts that people experience reactance (a motivational state characterized by negative affect and cognition) when they perceive threats to their autonomy. Reactance may lead to ""boomerang effects"" by which individuals engage in the opposed behavior.  Objectives : This experiment sought to determine whether a message encouraging marijuana (MJ) abstinence evoked greater reactance than a harm-reduction message and whether the message and reactance influenced individuals' attitudes, MJ craving, and intent to comply with the message request.  Methods : College students and community members ( n  = 388) participated in an online study where they were randomly assigned to receive a message promoting MJ abstinence or harm reduction. Regression analyses adjusting for MJ use, alcohol use, and age determined the effects of the message and reactance on individuals' attitudes, MJ craving, and intent to comply. Follow-up analyses determined the significant reactance subscales.  Results : The abstinence message evoked greater reactance than the harm reduction message and led to less favorable attitudes toward the advocated behavior. Across messages, reactance (specifically negative cognitive appraisal) was related to less favorable attitudes toward the advocated behavior and the study, as well as lower intent to comply. Additionally, reactance (specifically anger) was associated with greater self-reported craving.  Conclusions/Importance : Anti-MJ messages designed to discourage use might heighten reactance and inadvertently lead to greater craving and intent to use. The link between reactance and craving may be more affectively mediated than the link between reactance and message rejection.",2019,The link between reactance and craving may be more affectively mediated than the link between reactance and message rejection.,['Methods : College students and community members ( n \u2009=\u2009388) participated in an online study'],"[' ', 'message promoting MJ abstinence or harm reduction', 'Messaging and Psychological Reactance']",['Marijuana Craving'],"[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0679771', 'cui_str': 'Harm Minimization'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",388.0,0.0163103,The link between reactance and craving may be more affectively mediated than the link between reactance and message rejection.,"[{'ForeName': 'Melissa N', 'Initials': 'MN', 'LastName': 'Slavin', 'Affiliation': 'University at Albany, State University of New York, Albany, NY, USA.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Earleywine', 'Affiliation': 'University at Albany, State University of New York, Albany, NY, USA.'}]",Substance use & misuse,['10.1080/10826084.2019.1650771']
508,32180239,Better cognitive efficiency is associated with increased experimental anxiety.,"There is increased interest in the development of cognitive training targeting working memory (WM) to alleviate anxiety symptoms, but the effectiveness of such an approach is unclear. Improved understanding of the effect of cognitive training on anxiety may facilitate the development of more effective cognitive training treatment for anxiety disorders. This study uses an experimental approach to examine the interplay of WM and anxiety following WM training. Previous studies show that increased demand on WM reduces concurrent anxiety evoked by threat of shock (induced anxiety). However, improving WM pharmacologically or via exercise prevents this anxiolytic effect. Conceivably, improving WM frees up cognitive resources to process threat information, thereby increasing anxiety. The present study tested the hypothesis that practicing a high load WM (i.e., increased demand) task would improve WM, and thus, free cognitive resources to process threat of shock, resulting in more anxiety (i.e., greater startle) during a subsequent WM task. Participants were randomly assigned to two training groups. The active-training group (N = 20) was trained on a 1- (low load) & 3-back (high load) WM task, whereas the control-training group (N = 20) performed a 0-back WM task. The experimental phase, similar in both groups, consisted of a 1- & 3-back WM task performed during both threat of shock and safety. As predicted, active training improved WM accuracy and increased anxiety during the experimental 3-back WM task. Therefore, improving WM efficiency can increase anxiety, possibly by freeing WM resources to process threat information.",2020,"As predicted, active training improved WM accuracy and increased anxiety during the experimental 3-back WM task.",[],"['active-training group (N\xa0=\xa020) was trained on a 1- (low load) & 3-back (high load) WM task, whereas the control-training group (N\xa0=\xa020) performed a 0-back WM task', 'cognitive training']",['WM accuracy and increased anxiety'],[],"[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",20.0,0.0268519,"As predicted, active training improved WM accuracy and increased anxiety during the experimental 3-back WM task.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Grillon', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Lago', 'Affiliation': 'Department of Psychiatry, VA Boston Healthcare System, Boston, Massachusetts, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Stahl', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Beale', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Balderston', 'Affiliation': 'Center for Neuromodulation in Depression and Stress, Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': 'Section on Neurobiology of Fear and Anxiety, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland, USA.'}]",Psychophysiology,['10.1111/psyp.13559']
509,32170451,"Energy-dense, low-volume paediatric oral nutritional supplements improve total nutrient intake and increase growth in paediatric patients requiring nutritional support: results of a randomised controlled pilot trial.","Children with or at risk of faltering growth require nutritional support and are often prescribed oral nutritional supplements (ONS). This randomised controlled trial investigated the effects of energy-dense paediatric ONS (2.4 kcal/ml, 125 ml: cONS) versus 1.5 kcal/ml, 200 ml ONS (sONS) in community-based paediatric patients requiring oral nutritional support. Fifty-one patients (mean age 5.8 years (SD 3)) with faltering growth and/or requiring ONS to meet their nutritional requirements were randomised to cONS (n = 27) or sONS (n = 24) for 28 days. Nutrient intake, growth, ONS compliance and acceptability, appetite and gastro-intestinal tolerance were assessed. Use of the cONS resulted in significantly greater mean total daily energy (+ 531 kcal/day), protein (+ 10.1 g/day) and key micronutrient intakes compared with the sONS group at day 28 and over time, due to high ONS compliance (81% of patients ≥ 75%), maintained intake from diet alone and improved appetite in the cONS group, compared with the sONS group. Although growth increased in both intervention groups, results were significant in the cONS group (weight (p = 0.007), height (p < 0.001) and height z-score (p = 0.006)).Conclusions: This study shows that use of energy-dense (2.4 kcal/ml) low-volume paediatric-specific ONS leads to improved nutrient intakes, growth and appetite in paediatric patients requiring oral nutrition support compared with standard energy density ONS.Trial registration: The trial is registered at clinicaltrials.gov , identification number NCT02419599. What is Known: • Faltering growth is the failure of children to achieve adequate growth at a normal rate for their age and requires nutritional support, including the use of oral nutritional supplements (ONS). • Energy-dense, low-volume ONS have benefits over standard ONS in adults. What is New: • This is the first RCT to investigate the effects of energy-dense, low-volume ONS (2.4 kcal/ml, 125 ml) in children with faltering growth, showing significant improvements in total nutrient intake and increased growth. • Energy-dense, low-volume ONS can play a key role in the management of faltering growth.",2020,"Although growth increased in both intervention groups, results were significant in the cONS group (weight (p = 0.007), height (p < 0.001) and height z-score (p = 0.006)).Conclusions: This study shows that use of energy-dense (2.4 kcal/ml) low-volume paediatric-specific ONS leads to improved nutrient intakes, growth and appetite in paediatric patients requiring oral nutrition support compared with standard energy density ONS.Trial registration: The trial is registered at clinicaltrials.gov, identification number NCT02419599.What is Known:• Faltering growth is the failure of children to achieve adequate growth at a normal rate for their age and requires nutritional support, including the use of oral nutritional supplements (ONS).• Energy-dense, low-volume ONS have benefits over standard ONS in adults.","['paediatric patients requiring nutritional support', 'Fifty-one patients (mean age 5.8\xa0years (SD 3)) with faltering growth and/or requiring ONS to meet their nutritional requirements', 'Children with or at risk of faltering growth require nutritional support and are often prescribed oral nutritional supplements (ONS', 'community-based paediatric patients requiring oral nutritional support', 'paediatric patients requiring']","['oral nutrition support', 'cONS', '200\xa0ml ONS (sONS', 'sONS', 'energy-dense paediatric ONS']","['mean total daily energy', 'total nutrient intake', 'appetite', 'key micronutrient intakes', 'Nutrient intake, growth, ONS compliance and acceptability, appetite and gastro-intestinal tolerance', 'nutrient intakes, growth and appetite']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242739', 'cui_str': 'Nutritional Support'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0028719', 'cui_str': 'Nutrition Requirements'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0846669', 'cui_str': 'Oral nutritional support (regime/therapy)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0037683', 'cui_str': 'Sons'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]",,0.0502259,"Although growth increased in both intervention groups, results were significant in the cONS group (weight (p = 0.007), height (p < 0.001) and height z-score (p = 0.006)).Conclusions: This study shows that use of energy-dense (2.4 kcal/ml) low-volume paediatric-specific ONS leads to improved nutrient intakes, growth and appetite in paediatric patients requiring oral nutrition support compared with standard energy density ONS.Trial registration: The trial is registered at clinicaltrials.gov, identification number NCT02419599.What is Known:• Faltering growth is the failure of children to achieve adequate growth at a normal rate for their age and requires nutritional support, including the use of oral nutritional supplements (ONS).• Energy-dense, low-volume ONS have benefits over standard ONS in adults.","[{'ForeName': 'Gary P', 'Initials': 'GP', 'LastName': 'Hubbard', 'Affiliation': 'Nutricia Ltd, Medical Affairs, Trowbridge, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Fry', 'Affiliation': 'Nutricia Ltd, Medical Affairs, Trowbridge, UK.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Sorensen', 'Affiliation': 'Nutricia Ltd, Medical Affairs, Trowbridge, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Casewell', 'Affiliation': ""Department of Nutrition and Dietetics, Ashford and St Peter's Hospitals NHS Foundation Trust, Chertsey, UK.""}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Collins', 'Affiliation': 'Department of Nutrition and Dietetics, Cumbria Partnership NHS Foundation Trust, Whitehaven, UK.'}, {'ForeName': 'Annaruby', 'Initials': 'A', 'LastName': 'Cunjamalay', 'Affiliation': 'Department of Nutrition and Dietetics, Hampshire Hospitals NHS Foundation Trust, Winchester, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Simpson', 'Affiliation': 'Department of Nutrition and Dietetics, Hampshire Hospitals NHS Foundation Trust, Winchester, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Wall', 'Affiliation': 'Department of Nutrition and Dietetics, East Lancashire Hospitals NHS Trust, Blackburn, UK.'}, {'ForeName': 'Elmarie', 'Initials': 'E', 'LastName': 'Van Wyk', 'Affiliation': 'Department of Nutrition and Dietetics, Great Western Hospitals NHS Foundation Trust, Swindon, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Ward', 'Affiliation': 'Department of Nutrition and Dietetics, Cwm Taf University Health Board, Prince Charles Hospital, Merthyr Tydfil, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Hallowes', 'Affiliation': ""Department of Nutrition and Dietetics, Guy's and St Thomas' NHS Trust, London, UK.""}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Duggan', 'Affiliation': ""Department of Nutrition and Dietetics, Guy's and St Thomas' NHS Trust, London, UK.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Robison', 'Affiliation': 'Department of Nutrition and Dietetics, Lewisham and Greenwich NHS Trust, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gane', 'Affiliation': 'Department of Nutrition and Dietetics, Western Sussex Hospitals NHS Foundation Trust, Chichester, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Pope', 'Affiliation': 'Department of Nutrition and Dietetics, Western Sussex Hospitals NHS Foundation Trust, Chichester, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Clark', 'Affiliation': 'Department of Nutrition and Dietetics, Airedale NHS Foundation Trust, Keighley, UK.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Stratton', 'Affiliation': 'Nutricia Ltd, Medical Affairs, Trowbridge, UK. rjs@soton.ac.uk.'}]",European journal of pediatrics,['10.1007/s00431-020-03620-9']
510,32175586,Influence of Acetazolamide on Hand Strength and Manual Dexterity During a 30-h Simulated High Altitude Exposure.,"INTRODUCTION


High altitude missions pose significant challenges to Warfighter medical readiness and performance. Decreased circulating oxygen levels cause a decrease in exercise performance and can cause debilitating symptoms associated with acute mountain sickness, especially with rapid ascent. Acetazolamide (AZ) is known to minimize symptoms of acute mountain sickness, but it is unknown whether this medication alters hand strength and manual dexterity during altitude exposure.
MATERIALS AND METHODS


Ten male volunteers (22 ± 4 yr, 75.9 ± 13.7 kg, 174.9 ± 9.3 cm) participated in two separate 30 h simulated altitude exposures (496 mmHg, equivalent to 3,500 m, 20°C, 20% RH) in a hypobaric chamber. Participants were given either a placebo or 250 mg of AZ twice daily for 3.5 d (2 sea-level [SL] days + the 30 h altitude exposure) in a randomized, single-blind, crossover design. During SL and both altitude (ALT) exposures, hand function tests were performed, including hand grip and finger pinch strength tests, as well as the Purdue Pegboard (PP) and magazine loading tests to assess manual dexterity. Paired T tests and two-way repeated measure analysis of variance were used as appropriate to evaluate the effects of AZ and ALT. The value of p < 0.05 was accepted for statistical significance.
RESULTS


There were no influences of acute ALT exposure or AZ treatment on hand strength (eg, grip strength; SL: 39.2 ± 5.5 kg vs. ALT: 41.5 ± 6.9 kg, p > 0.05) or dexterity (eg, PPassembly; placebo: 35.5 ± 5.3 vs. AZ: 34.3 ± 4.6, p > 0.05) in our volunteers. Two dexterity tests (PPsum and magazine loading) showed improvements over time at ALT, regardless of treatment, where scores were improved after 10 h of exposure compared to at 1 h (eg, magazine loading: 56 ± 12 vs. 48 ± 10, p < 0.001). This pattern was not seen in the PPassembly test or any strength measurements.
CONCLUSIONS


Our results suggest that 500 mg/d of AZ does not influence hand strength or manual dexterity during a 30 h exposure to 3,500 m simulated ALT. Acute ALT exposure (1 h) did not influence dexterity or strength, although some measures of dexterity showed improvements as exposure time increased. We conclude that use of AZ to optimize medical readiness at ALT is unlikely to impair the Warfighter's ability to complete mission tasks that depend on hand function.",2020,"Acute ALT exposure (1 h) did not influence dexterity or strength, although some measures of dexterity showed improvements as exposure time increased.","['Ten male volunteers (22\xa0±\xa04\xa0yr, 75.9\xa0±\xa013.7\xa0kg, 174.9\xa0±\xa09.3\xa0cm) participated in two separate 30\xa0h simulated altitude exposures (496\xa0mmHg, equivalent to 3,500\xa0m, 20°C, 20% RH) in a hypobaric chamber']","['Acetazolamide (AZ', 'AZ', 'placebo or 250\xa0mg of AZ', 'Acetazolamide']","['dexterity or strength', 'hand strength or manual dexterity', 'Hand Strength and Manual Dexterity', 'acute ALT exposure or AZ treatment on hand strength']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0179879', 'cui_str': 'Hypobaric chamber (physical object)'}]","[{'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities (observable entity)'}, {'cui': 'C0242959', 'cui_str': 'Hand Strength'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",10.0,0.0161299,"Acute ALT exposure (1 h) did not influence dexterity or strength, although some measures of dexterity showed improvements as exposure time increased.","[{'ForeName': 'Beau R', 'Initials': 'BR', 'LastName': 'Yurkevicius', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}, {'ForeName': 'Karleigh E', 'Initials': 'KE', 'LastName': 'Bradbury', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Nixon', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Mitchell', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Luippold', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Mayer', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}, {'ForeName': 'Billie K', 'Initials': 'BK', 'LastName': 'Alba', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Salgado', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Charkoudian', 'Affiliation': 'Thermal and Mountain Medicine Division, United States Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Natick, MA 01760, USA.'}]",Military medicine,['10.1093/milmed/usaa041']
511,32175587,Human Papilloma Virus Vaccination Compliance in a Military Aviation Training Community.,"INTRODUCTION


Human Papilloma Virus (HPV) vaccination compliance as reported by the CDC in 2011 falls short of a national goal to have 80% of adolescents vaccine-complete by 2020. The Naval Aviation Schools Command, Pensacola, Florida offers a single point of contact for military aviation trainees offering near-complete capture of an HPV vaccine target population. The purpose of this study is to identify baseline HPV vaccination rates among military aviation trainees and whether or not the provision of educational materials at the start of aviation training would increase future HPV vaccination compliance.
MATERIALS AND METHODS


Approval to conduct this study was obtained from the Institutional Review Board of Naval Medical Center Portsmouth, Virginia. Our population of interest consisted of US Navy and Marine Corps student naval aviators, student naval flight officers (officers), and student enlisted air crew (enlisted) reporting for aviation related duty. A convenience sampling of officer and enlisted student classes checking in for training was performed over a period of 6 months. The first 3 months of students were assigned as the intervention group and the remaining 3 months of students were assigned to the control group. This study was conducted in two parts: (1) an anonymous survey captured cross-sectional data of self-reported HPV vaccine use, and (2) prospective analysis of service members' HPV vaccine rates before and after educational intervention as documented within the military's electronic health record system, Armed Forces Health Longitudinal Technology Application (AHLTA).
RESULTS


AHLTA immunization status was evaluated for 1,164 personnel; 114 (9.8%) were excluded for missing basic vaccination information. Of the remaining 1,050, another 199 (19%) members were excluded as already vaccine complete (evidenced by three shots documented) prior to entry into the study. Within the 199 service members with documented baseline HPV vaccination completion, 197/199 (99%) were officers and 2/199 (0.1%) were enlisted. A total of 851 personnel were included for prospective analysis. Person-time of 100 person years was used and the vaccination rate translates to 16.62/100 person years (95% CI 11.29, 23.59) within intervention vs. 2.96/100 person years (95% CI 0.80, 7.58) within control groups and are significantly different (P = 0.0001). Comparing intervention and control groups, rate ratios = 5.61 (95% CI 2.14, 18.64) and rate differences = 13.66 (95% CI 7.13, 20.19). Among intervention group survey responders who previously reported nonvaccine use, 50.5% reported a change in opinion about obtaining the vaccination, with a higher proportion of enlisted members reporting a change in opinion (62.8% vs. 39.7%, P = 0.0053).
CONCLUSIONS


Electronic health records immunizations review noted a baseline vaccine completion rate of 19%. Our study showed a health inequity between enlisted and officers, with officers having 99% of the documented baseline completion rates per AHLTA data. Our prospective analysis noted statistically significant rate differences of 13.66% and rate ratios of 5.61 between intervention and control groups. This analysis of AHLTA data combined with survey response of 50.5% indicating a change in opinion about HPV vaccine use among those who had not yet started vaccine series suggests targeted education would be a low-cost intervention to improve HPV vaccine use rates.",2020,"Comparing intervention and control groups, rate ratios = 5.61","['military aviation trainees', ""two parts: (1) an anonymous survey captured cross-sectional data of self-reported HPV vaccine use, and (2) prospective analysis of service members' HPV vaccine rates before and after educational intervention as documented within the military's electronic health record system, Armed Forces Health Longitudinal Technology Application (AHLTA"", '199 service members with documented baseline HPV vaccination completion, 197/199 (99%) were officers and 2/199 (0.1%) were enlisted', 'Human Papilloma Virus Vaccination Compliance in a Military Aviation Training Community', 'Of the remaining 1,050, another 199 (19%) members were excluded as already vaccine complete (evidenced by three shots documented) prior to entry into the study', 'A total of 851 personnel']",['aviation training'],"['health inequity', 'baseline HPV vaccination rates', 'rate ratios', 'vaccination rate translates']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0004430', 'cui_str': 'Aviation'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0004430', 'cui_str': 'Aviation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",851.0,0.0734173,"Comparing intervention and control groups, rate ratios = 5.61","[{'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Porter', 'Affiliation': 'Department of Aviation Medicine, Navy Medicine Readiness and Training Unit Jacksonville, Building 964 Enterprise Ave., Jacksonville, FL 32212.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Stoker', 'Affiliation': 'Naval School of Aviation Safety, 181 Chambers Ave, Pensacola, FL 32508.'}, {'ForeName': 'Samantha R', 'Initials': 'SR', 'LastName': 'Seals', 'Affiliation': 'Department of Mathematics and Statistics, University of West Florida, Building 4, 11000 University Parkway, Pensacola, FL 32514.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Drollinger', 'Affiliation': 'Naval Aerospace Medical Institute, 340 Hulse Road, Pensacola, FL 32508.'}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Schutte', 'Affiliation': 'Dental Department, 23rd Dental Company, PO Box 78830, Twentynine Palms, CA 92278.'}, {'ForeName': 'Jyl W', 'Initials': 'JW', 'LastName': 'Bean', 'Affiliation': 'Department of Aviation Medicine, Navy Medicine Readiness and Training Unit Jacksonville, Building 964 Enterprise Ave., Jacksonville, FL 32212.'}, {'ForeName': 'G Merrill', 'Initials': 'GM', 'LastName': 'Rice', 'Affiliation': 'USS Gerald Ford (CVN 78), FPO AE 09523, VA.'}]",Military medicine,['10.1093/milmed/usaa024']
512,32175948,McGrath Video Laryngoscope Versus Macintosh Direct Laryngoscopy for Intubation of Morbidly Obese Patients: A Randomized Trial.,"BACKGROUND


Two-thirds of the US population is considered obese and about 8% morbidly obese. Obese patients may present a unique challenge to anesthesia clinicians in airway management. Videolaryngoscopes may provide better airway visualization, which theoretically improves intubation success. However, previous work in morbidly obese patients was limited. We therefore tested the primary hypothesis that the use of McGrath video laryngoscope improves visualization of the vocal cords versus Macintosh direct laryngoscopy (Teleflex, Morrisville, NC) in morbidly obese patients.
METHODS


We enrolled 130 surgical patients, aged 18-99 years, with a body mass index ≥40 kg/m and American Society of Anaesthesiologists (ASA) physical status I-III. Patients were randomly allocated 1:1-stratified for patient's body mass index ≥50 kg/m-to McGrath video laryngoscope versus direct laryngoscopy with a Macintosh blade. The study groups were compared on glottis visualization, defined as improved Cormack and Lehane classification, with proportional odds logistic regression model.
RESULTS


McGrath video laryngoscope provided significantly better glottis visualization than Macintosh direct laryngoscopy with an estimated odds ratio of 4.6 (95% confidence interval [CI], 2.2-9.8; P < .01). We did not observe any evidence that number of intubation attempts and failed intubations increased or decreased.
CONCLUSIONS


McGrath video laryngoscope improves glottis visualization versus Macintosh direct laryngoscopy in morbidly obese patients. Large clinical trials are needed to determine whether improved airway visualization with videolaryngoscopy reduces intubation attempts and failures.",2020,"CONCLUSIONS


McGrath video laryngoscope improves glottis visualization versus Macintosh direct laryngoscopy in morbidly obese patients.","['morbidly obese patients', '130 surgical patients, aged 18-99 years, with a body mass index ≥40 kg/m and American Society of Anaesthesiologists (ASA) physical status I-III', 'Obese patients', 'Morbidly Obese Patients']","['McGrath Video Laryngoscope Versus Macintosh Direct Laryngoscopy', ""patient's body mass index ≥50 kg/m-to McGrath video laryngoscope versus direct laryngoscopy with a Macintosh blade"", 'McGrath video laryngoscope', 'Macintosh direct laryngoscopy (Teleflex, Morrisville, NC', 'videolaryngoscopy']","['number of intubation attempts and failed intubations', 'intubation success', 'glottis visualization']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscopes'}, {'cui': 'C0392823', 'cui_str': 'Direct laryngoscopy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2948008', 'cui_str': 'Blade'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1301877', 'cui_str': 'Failed intubation'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}]",130.0,0.176566,"CONCLUSIONS


McGrath video laryngoscope improves glottis visualization versus Macintosh direct laryngoscopy in morbidly obese patients.","[{'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Ruetzler', 'Affiliation': 'From the Departments of Outcomes Research and General Anesthesiology.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Rivas', 'Affiliation': 'Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Cohen', 'Affiliation': 'Division of Anesthesia, Critical Care and Pain Management, Tel-Aviv Medical Center, Sackler Faculty of Medicine, Tel-Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Lauretta', 'Initials': 'L', 'LastName': 'Mosteller', 'Affiliation': 'Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Departments of General Anesthesiology, Anesthesiology Institute.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Keebler', 'Affiliation': 'Departments of General Anesthesiology, Anesthesiology Institute.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Maheshwari', 'Affiliation': 'From the Departments of Outcomes Research and General Anesthesiology.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Steckner', 'Affiliation': 'Departments of General Anesthesiology, Anesthesiology Institute.'}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Departments of General Anesthesiology, Anesthesiology Institute.'}, {'ForeName': 'Chahar', 'Initials': 'C', 'LastName': 'Praveen', 'Affiliation': 'From the Departments of Outcomes Research and General Anesthesiology.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Khanna', 'Affiliation': 'From the Departments of Outcomes Research and General Anesthesiology.'}, {'ForeName': 'Natalya', 'Initials': 'N', 'LastName': 'Makarova', 'Affiliation': 'Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'From the Departments of Outcomes Research and General Anesthesiology.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004747']
513,30413390,Early Catheter Removal After Robot-assisted Radical Prostatectomy: Results from a Prospective Single-institutional Randomized Trial (Ripreca Study).,"BACKGROUND


The adoption of robotic technology in the treatment of prostate cancer (PCa) could lead to improvement in outcomes.
OBJECTIVE


To evaluate feasibility, to compare functional outcomes, and to assess the economic benefits of removing catheter on the postoperative day (POD) 3 versus POD 5 after robot-assisted radical prostatectomy (RARP).
DESIGN, SETTING, AND PARTICIPANTS


From September 2016 to May 2017, patients selected to undergo RARP for clinically localized PCa at a high-volume center were prospectively randomized into group 1 (POD 3; n=72) versus group 2 (POD 5, n=74).
INTERVENTION


All patients underwent RARP with anatomical posterior and anterior reconstruction.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was to compare acute urinary retention (AUR) and urinary leakage rate in the two groups. The secondary endpoints were early and mid-term postoperative functional outcomes assessed through questionnaires (ICIQ-MLUTS, IPSS), early continence rate, and postoperative pain/discomfort (visual analog scale score). The economic impact of early catheter removal was also assessed.
RESULTS AND LIMITATIONS


AUR was reported in two (1.4%) cases, one for each study group (p=0.9). One case of vesicourethral leakage was reported (0.7%) in group 1. Urethral discomfort and pain at discharge was significantly higher in group 2 (p=0.03). In our clinical practice, POD 3 catheter removal approach would determine a saving of approximately €80 000 and 405 d of hospitalization yearly. The main limitation is the small sample size.
CONCLUSIONS


Early catheter removal after RARP does not lead to an increase in perioperative complications. No negative effect on early and mid-term functional outcomes was observed. A significant impact on saving economic resources was reported.
PATIENT SUMMARY


We demonstrated that early catheter removal has no negative effect on spontaneous voiding, complications, or urinary continence recovery after robot-assisted radical prostatectomy.",2020,"We demonstrated that early catheter removal has no negative effect on spontaneous voiding, complications, or urinary continence recovery after robot-assisted radical prostatectomy.","['From September 2016 to May 2017, patients selected to undergo RARP for clinically localized PCa at a high-volume center', 'prostate cancer (PCa']","['POD 5 after robot-assisted radical prostatectomy (RARP', 'RARP with anatomical posterior and anterior reconstruction', 'Robot-assisted Radical Prostatectomy', 'robot-assisted radical prostatectomy', 'Early Catheter Removal']","['Urethral discomfort and pain at discharge', 'spontaneous voiding, complications, or urinary continence recovery', 'perioperative complications', 'vesicourethral leakage', 'early and mid-term postoperative functional outcomes assessed through questionnaires (ICIQ-MLUTS, IPSS), early continence rate, and postoperative pain/discomfort (visual analog scale score', 'acute urinary retention (AUR) and urinary leakage rate', 'saving economic resources']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter (procedure)'}]","[{'cui': 'C0041967', 'cui_str': 'Urethra'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0341742', 'cui_str': 'Acute retention of urine (disorder)'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",,0.0767053,"We demonstrated that early catheter removal has no negative effect on spontaneous voiding, complications, or urinary continence recovery after robot-assisted radical prostatectomy.","[{'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Lista', 'Affiliation': 'Urology, Humanitas Clinical and Research Hospital, Rozzano, Milan, Italy. Electronic address: giuliana.lista@aulss8.veneto.it.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Lughezzani', 'Affiliation': 'Urology, Humanitas Clinical and Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Nicolò Maria', 'Initials': 'NM', 'LastName': 'Buffi', 'Affiliation': 'Urology, Humanitas Clinical and Research Hospital, Rozzano, Milan, Italy; Humanitas University, Rozzano, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Saita', 'Affiliation': 'Urology, Humanitas Clinical and Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Vanni', 'Affiliation': 'Business Operations Office, Humanitas Clinical and Research Center, Milan, Italy; Department of Biomedical Science, Humanitas University, Milan, Italy.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Hurle', 'Affiliation': 'Urology, Humanitas Clinical and Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Cardone', 'Affiliation': 'Urology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, FG, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Peschechera', 'Affiliation': 'Urology, Humanitas Clinical and Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Forni', 'Affiliation': 'Humanitas University, Rozzano, Milan, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Lazzeri', 'Affiliation': 'Urology, Humanitas Clinical and Research Hospital, Rozzano, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Guazzoni', 'Affiliation': 'Urology, Humanitas Clinical and Research Hospital, Rozzano, Milan, Italy; Humanitas University, Rozzano, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Casale', 'Affiliation': 'Urology, Humanitas Clinical and Research Hospital, Rozzano, Milan, Italy.'}]",European urology focus,['10.1016/j.euf.2018.10.013']
514,31154601,Proof of concept trial for a new theory-based intervention to promote child and adult behavior change.,"Interventions to change children's behavior typically target adults or children, but rarely both. The aims were to: (a) evaluate acceptability and feasibility of an innovative theory-based intervention designed to change both child and adult behavior, and (b) generate effect sizes for a definitive randomized controlled trial. The oral health of sixty children aged 5-9 years with a repaired cleft lip and/or palate was assessed before randomization to one of three conditions: (a) control group, (b) intervention group in which children and adults were asked to form implementation intentions, or (c) intervention plus booster group in which adults were additionally sent a reminder about the implementation intentions they and their children formed. Oral health assessments were repeated at 6-month follow-up alongside exit interviews. The procedures proved popular and participants exposed to the intervention additionally reported believing that forming implementation intentions was effective. Descriptive statistics generally showed oral health improvements across all conditions, although the effects were more marked in the intervention plus booster condition, where plaque improved by 44.53%, gingivitis improved by 20.00% and free sugar consumption improved by 8.92% (vs. 6.43% improvement, 15.00% deterioration and 15.58% improvement in the control group, respectively). Data collection procedures were acceptable and the intervention feasible. The effect sizes suggest that the intervention plus booster condition has sufficient promise to proceed to a fully-powered randomized controlled trial. The intervention has the potential to be adapted to tackle other child health behaviors and to be deployed at scale.",2020,"Descriptive statistics generally showed oral health improvements across all conditions, although the effects were more marked in the intervention plus booster condition, where plaque improved by 44.53%, gingivitis improved by 20.00% and free sugar consumption improved by 8.92% (vs. 6.43% improvement, 15.00% deterioration and 15.58% improvement in the control group, respectively).",['sixty children aged 5-9\xa0years with a repaired cleft lip and/or palate'],"['innovative theory-based intervention', 'control group, (b) intervention group in which children and adults were asked to form implementation intentions, or (c) intervention plus booster group in which adults were additionally sent a reminder about the implementation intentions']","['free sugar consumption', 'gingivitis', 'Oral health assessments']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0008924', 'cui_str': 'Harelip'}, {'cui': 'C0700374', 'cui_str': 'Palate'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1697762', 'cui_str': 'Booster'}]","[{'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0029162'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",60.0,0.0666907,"Descriptive statistics generally showed oral health improvements across all conditions, although the effects were more marked in the intervention plus booster condition, where plaque improved by 44.53%, gingivitis improved by 20.00% and free sugar consumption improved by 8.92% (vs. 6.43% improvement, 15.00% deterioration and 15.58% improvement in the control group, respectively).","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Armitage', 'Affiliation': 'Manchester Centre for Health Psychology, School of Health Sciences, Manchester Academic Health Science Centre, University of Manchester, Coupland Street, Oxford Road, Manchester, M13 9PL, UK. chris.armitage@manchester.ac.uk.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': 'Manchester Centre for Health Psychology, School of Health Sciences, Manchester Academic Health Science Centre, University of Manchester, Coupland Street, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Mooney', 'Affiliation': 'Manchester Centre for Health Psychology, School of Health Sciences, Manchester Academic Health Science Centre, University of Manchester, Coupland Street, Oxford Road, Manchester, M13 9PL, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tierney', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Callery', 'Affiliation': 'Manchester Centre for Health Psychology, School of Health Sciences, Manchester Academic Health Science Centre, University of Manchester, Coupland Street, Oxford Road, Manchester, M13 9PL, UK.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00061-0']
515,31537574,"Heart Rehabilitation in patients awaiting Open heart surgery targeting to prevent Complications and to improve Quality of life (Heart-ROCQ): study protocol for a prospective, randomised, open, blinded endpoint (PROBE) trial.","INTRODUCTION


The rising prevalence of modifiable risk factors (eg, obesity, hypertension and physical inactivity) is causing an increase in possible avoidable complications in patients undergoing cardiac surgery. This study aims to assess whether a combined preoperative and postoperative multidisciplinary cardiac rehabilitation (CR) programme (Heart-ROCQ programme) can improve functional status and reduce surgical complications, readmissions and major adverse cardiac events (MACE) as compared with standard care.
METHODS AND ANALYSIS


Patients (n=350) are randomised to the Heart-ROCQ programme or standard care. The Heart-ROCQ programme consists of a preoperative optimisation phase while waiting for surgery (three times per week, minimum of 3 weeks), a postoperative inpatient phase (3 weeks) and an outpatient CR phase (two times per week, 4 weeks). Patients receive multidisciplinary treatment (eg, physical therapy, dietary advice, psychological sessions and smoking cessation). Standard care consists of 6 weeks of postsurgery outpatient CR with education and physical therapy (two times per week). The primary outcome is a composite weighted score of functional status, surgical complications, readmissions and MACE, and is evaluated by a blinded endpoint committee. The secondary outcomes are length of stay, physical and psychological functioning, lifestyle risk factors, and work participation. Finally, an economic evaluation is performed. Data are collected at six time points: at baseline (start of the waiting period), the day before surgery, at discharge from the hospital, and at 3, 7 and 12 months postsurgery.
ETHICS AND DISSEMINATION


This study will be conducted according to the principles of the Declaration of Helsinki (V.8, October 2013). The protocol has been approved by the Medical Ethical Review Board of the UMCG (no 2016/464). Results of this study will be submitted to a peer-reviewed scientific journal and can be presented at national and international conferences.
TRIAL REGISTRATION NUMBER


NCT02984449.",2019,"The primary outcome is a composite weighted score of functional status, surgical complications, readmissions and MACE, and is evaluated by a blinded endpoint committee.","['patients awaiting Open heart surgery', 'Patients (n=350', 'patients undergoing cardiac surgery']","['Heart-ROCQ programme or standard care', 'combined preoperative and postoperative multidisciplinary cardiac rehabilitation (CR) programme (Heart-ROCQ programme', 'multidisciplinary treatment (eg, physical therapy, dietary advice, psychological sessions and smoking cessation']","['Quality of life (Heart-ROCQ', 'length of stay, physical and psychological functioning, lifestyle risk factors, and work participation', 'composite weighted score of functional status, surgical complications, readmissions and MACE, and is evaluated by a blinded endpoint committee']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery (procedure)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}]","[{'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0204932', 'cui_str': 'Diet education (procedure)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0034380'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}]",,0.0587359,"The primary outcome is a composite weighted score of functional status, surgical complications, readmissions and MACE, and is evaluated by a blinded endpoint committee.","[{'ForeName': 'Johanneke', 'Initials': 'J', 'LastName': 'Hartog', 'Affiliation': 'Department of Cardio-thoracic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands j.hartog@umcg.nl.'}, {'ForeName': 'Fredrike', 'Initials': 'F', 'LastName': 'Blokzijl', 'Affiliation': 'Department of Cardio-thoracic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Dijkstra', 'Affiliation': 'Department of Cardio-thoracic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Mike J L', 'Initials': 'MJL', 'LastName': 'DeJongste', 'Affiliation': 'University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Michiel F', 'Initials': 'MF', 'LastName': 'Reneman', 'Affiliation': 'Department of Rehabilitation Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Dieperink', 'Affiliation': 'Department of Critical Care, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Iwan C C', 'Initials': 'ICC', 'LastName': 'van der Horst', 'Affiliation': 'Department of Critical Care, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Joke', 'Initials': 'J', 'LastName': 'Fleer', 'Affiliation': 'Department of Health Psychology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Lucas H V', 'Initials': 'LHV', 'LastName': 'van der Woude', 'Affiliation': 'Department of Rehabilitation Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'van der Harst', 'Affiliation': 'Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Massimo A', 'Initials': 'MA', 'LastName': 'Mariani', 'Affiliation': 'Department of Cardio-thoracic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-031738']
516,28236077,Intervention Mediators in a Randomized Controlled Trial to Increase Colonoscopy Uptake Among Individuals at Increased Risk of Familial Colorectal Cancer.,"BACKGROUND


Understanding the pathways by which interventions achieve behavioral change is important for optimizing intervention strategies.
PURPOSE


We examined mediators of behavior change in a tailored-risk communication intervention that increased guideline-based colorectal cancer screening among individuals at increased familial risk.
METHODS


Participants at increased familial risk for colorectal cancer (N = 481) were randomized to one of two arms: (1) a remote, tailored-risk communication intervention (Tele-Cancer Risk Assessment and Evaluation (TeleCARE)) or (2) a mailed educational brochure intervention.
RESULTS


Structural equation modeling showed that participants in TeleCARE were more likely to get a colonoscopy. The effect was partially mediated through perceived threat (β = 0.12, p < 0.05), efficacy beliefs (β = 0.12, p < 0.05), emotions (β = 0.22, p < 0.001), and behavioral intentions (β = 0.24, p < 0.001). Model fit was very good: comparative fit index = 0.95, root-mean-square error of approximation = 0.05, and standardized root-mean-square residual = 0.08.
CONCLUSION


Evaluating mediating variables between an intervention (TeleCARE) and a primary outcome (colonoscopy) contributes to our understanding of underlying mechanisms that lead to health behavior change, thus leading to better informed and designed future interventions.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov , NCT01274143.",2017,"Model fit was very good: comparative fit index = 0.95, root-mean-square error of approximation = 0.05, and standardized root-mean-square residual = 0.08.
","['individuals at increased familial risk', 'Participants at increased familial risk for colorectal cancer (N\xa0=\xa0481']","['remote, tailored-risk communication intervention (Tele-Cancer Risk Assessment and Evaluation (TeleCARE)) or (2) a mailed educational brochure intervention', 'tailored-risk communication intervention']","['Risk of Familial Colorectal Cancer', 'efficacy beliefs', 'behavioral intentions', 'Colonoscopy Uptake']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}, {'cui': 'C3661840', 'cui_str': 'Assessment for risk of neoplastic disease'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]",481.0,0.0534074,"Model fit was very good: comparative fit index = 0.95, root-mean-square error of approximation = 0.05, and standardized root-mean-square residual = 0.08.
","[{'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'Brumbach', 'Affiliation': 'Department of Individual, Family, & Community Education, University of New Mexico, Albuquerque, NM, USA. BBrumbach@unm.edu.'}, {'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Birmingham', 'Affiliation': 'Department of Psychology, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Watcharaporn', 'Initials': 'W', 'LastName': 'Boonyasiriwat', 'Affiliation': 'Faculty of Psychology, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Walters', 'Affiliation': 'Department of School of Public Health Behavioral and Community Health, University of North Texas Health Science Center, Fort Worth, TX, USA.'}, {'ForeName': 'Anita Y', 'Initials': 'AY', 'LastName': 'Kinney', 'Affiliation': 'University of New Mexico Comprehensive Cancer Center, Division of Epidemiology, Biostatistics, and Prevention, Department of Internal Medicine, School of Medicine, University of New Mexico, Albuquerque, NM, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1007/s12160-017-9893-1']
517,30644774,Randomized Effectiveness Trial of the New Beginnings Program for Divorced Families with Children and Adolescents.,"This study presents findings from a randomized effectiveness trial of the New Beginnings Program (NBP), which has demonstrated efficacy in 2 prior randomized efficacy trials. Family courts in 4 counties facilitated recruitment of divorcing and separating parents, and providers in community agencies delivered the program. Participants were 830 parents of children ages 3-18 who were randomized to receive either the 10-session NBP or an active 2-session comparison condition in which parents learned about the same parenting skills but did not complete home practice of these skills. Parents were ethnically diverse (59.4% non-Hispanic White, 31.4% Hispanic, 9.2% other race or ethnicity). Multiple rater assessments of parenting, interparental conflict, and child mental health problems were conducted at pretest, posttest, and 10-month follow-up. The results indicated positive moderated effects of the NBP as compared with the active control condition to strengthen parenting at posttest and to reduce child mental health problems at posttest and 10 months. Many of these moderated effects showed positive benefits for non-Hispanic White families but not for Hispanic families. The findings indicate support for the effectiveness of the NBP when delivered by community-based agencies but also indicate the need for further adaptations to make the program effective for Hispanic parents.",2020,The results indicated positive moderated effects of the NBP as compared with the active control condition to strengthen parenting at posttest and to reduce child mental health problems at posttest and 10 months.,"['Divorced Families with Children and Adolescents', 'Hispanic parents', 'Parents were ethnically diverse (59.4% non-Hispanic White, 31.4% Hispanic, 9.2% other race or ethnicity', 'Participants were 830 parents of children ages 3-18 who']","['10-session NBP or an active 2-session comparison condition in which parents learned about the same parenting skills but did not complete home practice of these skills', 'New Beginnings Program', 'NBP', 'New Beginnings Program (NBP']","['child mental health problems', 'Multiple rater assessments of parenting, interparental conflict, and child mental health problems']","[{'cui': 'C0086170', 'cui_str': 'Divorced'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C4517889', 'cui_str': '830 (qualifier value)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1955961', 'cui_str': 'Interparental Conflict'}]",830.0,0.0488218,The results indicated positive moderated effects of the NBP as compared with the active control condition to strengthen parenting at posttest and to reduce child mental health problems at posttest and 10 months.,"[{'ForeName': 'Irwin', 'Initials': 'I', 'LastName': 'Sandler', 'Affiliation': 'REACH Institute and Department of Psychology, Arizona State University.'}, {'ForeName': 'Sharlene', 'Initials': 'S', 'LastName': 'Wolchik', 'Affiliation': 'REACH Institute and Department of Psychology, Arizona State University.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Mazza', 'Affiliation': 'REACH Institute and Department of Psychology, Arizona State University.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gunn', 'Affiliation': 'REACH Institute and Department of Psychology, Arizona State University.'}, {'ForeName': 'Jenn-Yun', 'Initials': 'JY', 'LastName': 'Tein', 'Affiliation': 'REACH Institute and Department of Psychology, Arizona State University.'}, {'ForeName': 'Cady', 'Initials': 'C', 'LastName': 'Berkel', 'Affiliation': 'REACH Institute and Department of Psychology, Arizona State University.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'REACH Institute and Department of Psychology, Arizona State University.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Porter', 'Affiliation': 'REACH Institute and Department of Psychology, Arizona State University.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2018.1540008']
518,31726485,Effects of continuous positive airway pressure on blood pressure in obstructive sleep apnea patients: The Apnea Positive Pressure Long-term Efficacy Study (APPLES).,"Obstructive sleep apnea is associated with hypertension, and short-term studies have demonstrated a modest reduction in blood pressure with continuous positive airway pressure therapy. We evaluated the effects of continuous positive airway pressure versus sham continuous positive airway pressure on blood pressure in 1,101 participants with obstructive sleep apnea from the Apnea Positive Pressure Long-term Efficacy Study, a randomized, sham-controlled double-blinded study designed to assess the impact of continuous positive airway pressure on neurocognition. Participants with apnea-hypopnea index ≥ 10 were randomly assigned to continuous positive airway pressure or sham continuous positive airway pressure. Blood pressures measured in the morning and evening at baseline, 2 months and 6 months were analysed post hoc using a mixed-model repeated-measures analysis of variance. The largest magnitude reduction was approximately 2.4 mmHg in morning systolic pressure that occurred at 2 months in the continuous positive airway pressure arm as compared with an approximate 0.5 mmHg reduction in the sham group (continuous positive airway pressure effect -1.9 mmHg, p = .008). At 6 months, the difference between groups was diminished and no longer statistically significant (continuous positive airway pressure effect -0.9 mmHg, p = .12). Sensitivity analysis with use of multiple imputation approaches to account for missing data did not change the results. Treatment with continuous positive airway pressure for obstructive sleep apnea reduces morning but not evening blood pressure in a population with well-controlled blood pressure. The effect was greater after 2 than after 6 months of treatment.",2020,"At 6 months, the difference between groups was diminished and no longer statistically significant (continuous positive airway pressure effect -0.9 ","['1,101 participants with obstructive sleep apnea from the Apnea Positive Pressure Long-term Efficacy Study', 'obstructive sleep apnea patients', 'Participants with apnea-hypopnea index\u2005≥\xa010']","['continuous positive airway pressure or sham continuous positive airway pressure', 'continuous positive airway pressure', 'continuous positive airway pressure versus sham continuous positive airway pressure']","['Blood pressures', 'morning systolic pressure', 'blood pressure', 'Obstructive sleep apnea']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]",1101.0,0.0328835,"At 6 months, the difference between groups was diminished and no longer statistically significant (continuous positive airway pressure effect -0.9 ","[{'ForeName': 'Sogol', 'Initials': 'S', 'LastName': 'Javaheri', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Gottlieb', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Stuart F', 'Initials': 'SF', 'LastName': 'Quan', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",Journal of sleep research,['10.1111/jsr.12943']
519,32162278,A stepwise titration protocol for oral appliance therapy in positional obstructive sleep apnea patients: proof of concept.,"PURPOSE


In patients with positional obstructive sleep apnea (POSA), oral appliance therapy (OAT) is among the first-line treatments. The aim of this study was to evaluate the effects of a new standardized stepwise titration protocol for OAT in a group of patients with POSA.
METHODS


This was an observational intervention trial. Patients who were previously randomized to the OAT intervention arm of a comparison study comprised the subjects for this study. These patients, who had mild to moderate POSA, were assessed after 3 and 12 months for treatment efficacy, objective adherence by temperature microsensor, and side effects. The titration of OAT was performed using a standardized stepwise titration protocol including advancement levels of 60%, 75%, and 90% of the maximum mandibular protrusion. The optimal advancement level per individual was based on a weighted compromise between efficacy and side effects.
RESULTS


In total, 36 patients were included and all completed the titration protocol after 3 months. At baseline, the OAT was set at 60% of the maximal mandibular protrusion position. At a 3-month evaluation, the advancement remained at 60% in 16 patients (44%) and reached 75% advancement in 20 patients (56%). Mean apnea-hypopnea index decreased from 12.9 events per hour (9.1-16.7) to 6.9 (3.7-10.3) (P < 0.001), and median objective adherence was 97.4 (61.4-100.00) after 3 months. The 12-month analysis showed consistent results and good OAT tolerance. Six patients (16.7%) terminated OAT and one patient (2.8%) was lost to follow-up.
CONCLUSIONS


This standardized stepwise titration protocol for OAT showed good efficacy, good OAT tolerance, and good objective adherence in patients with mild to moderate POSA. Therefore, the protocol is recommended in research projects to improve standardization of methods between studies and in clinical practice for its practical feasibility.",2020,"Mean apnea-hypopnea index decreased from 12.9 events per hour (9.1-16.7) to 6.9 (3.7-10.3) (P < 0.001), and median objective adherence was 97.4 (61.4-100.00) after 3 months.","['positional obstructive sleep apnea patients', '36 patients were included and all completed the titration protocol after 3 months', 'patients with POSA.\nMETHODS', 'patients with positional obstructive sleep apnea (POSA', 'patients with mild to moderate POSA']","['oral appliance therapy (OAT', 'OAT intervention']","['median objective adherence', 'Mean apnea-hypopnea index', 'good OAT tolerance']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243112'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]",36.0,0.0493953,"Mean apnea-hypopnea index decreased from 12.9 events per hour (9.1-16.7) to 6.9 (3.7-10.3) (P < 0.001), and median objective adherence was 97.4 (61.4-100.00) after 3 months.","[{'ForeName': 'M H T', 'Initials': 'MHT', 'LastName': 'de Ruiter', 'Affiliation': 'Department of Oral and Maxillofacial Surgery of the Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. m.h.deruiter@amsterdamumc.nl.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Aarab', 'Affiliation': 'Department of Orofacial Pain and Dysfunction of the Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'de Vries', 'Affiliation': 'Department of Orofacial Pain and Dysfunction of the Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Lobbezoo', 'Affiliation': 'Department of Orofacial Pain and Dysfunction of the Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'de Lange', 'Affiliation': 'Department of Oral and Maxillofacial Surgery of the Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.'}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02045-w']
520,32157126,The usefulness of endotracheal tube twisting in facilitating tube delivery to glottis opening during GlideScope intubation in infants: randomized trial.,"Despite an excellent view of the glottis, technical difficulties with endotracheal tube delivery remains in GlideScope intubation. We evaluated whether a spiral-shape twisted tube can facilitate placement of the tracheal tube tip at the center of glottis opening compared to conventional tube for GlideScope intubation in infants. Eighty-six infants were randomly placed in either the conventional tube group (group C) or the twist tube group (group T). In group T, the shaft of the tube was manually twisted into a loose spiral shape. The primary outcome was the initial center location of the tube tip at the glottis opening, and the secondary outcome was total tube handling time. The initial center location rate of the tube tip at the glottis opening was significantly higher in group T than in group C (88% [38/43] vs. 47% [20/43], P < 0.001). In addition, total tube handling time (sec) was significantly shorter in group T than in group C (15.4 ± 4.7 vs. 18.2 ± 5.3, P = 0.012). In this study, the spiral shape twist tube successfully improved the rate of initial center location of the tube tip at glottis opening and facilitated tube delivery in GlideScope intubation in infants.",2020,"In addition, total tube handling time (sec) was significantly shorter in group T than in group C (15.4 ± 4.7 vs. 18.2 ± 5.3, P = 0.012).","['infants', 'Eighty-six infants']","['endotracheal tube twisting', 'conventional tube group (group C) or the twist tube group']","['initial center location rate of the tube tip at the glottis opening', 'total tube handling time\xa0(sec', 'rate of initial center location', 'initial center location of the tube tip at the glottis opening, and the secondary outcome was total tube handling time']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0040480', 'cui_str': 'Musculoskeletal torsion (observable entity)'}]","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018578', 'cui_str': 'Handling'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",86.0,0.0308756,"In addition, total tube handling time (sec) was significantly shorter in group T than in group C (15.4 ± 4.7 vs. 18.2 ± 5.3, P = 0.012).","[{'ForeName': 'Jeong Jin', 'Initials': 'JJ', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Oh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young Hee', 'Initials': 'YH', 'LastName': 'Shin', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Eunjin', 'Initials': 'E', 'LastName': 'Kwon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji Seon', 'Initials': 'JS', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. jiseon78.jeong@samsung.com.'}]",Scientific reports,['10.1038/s41598-020-61321-7']
521,31475652,Prenatal and childhood exposures are associated with thymulin concentrations in young adolescent children in rural Nepal.,"The thymus undergoes a critical period of growth and development early in gestation and, by mid-gestation, immature thymocytes are subject to positive and negative selection. Exposure to undernutrition during these periods may permanently affect phenotype. We measured thymulin concentrations, as a proxy for thymic size and function, in children (n = 290; aged 9-13 years) born to participants in a cluster-randomized trial of maternal vitamin A or β-carotene supplementation in rural Nepal (1994-1997). The geometric mean (95% confidence interval) thymulin concentration was 1.37 ng/ml (1.27, 1.47). A multivariate model of early-life exposures revealed a positive association with gestational age at delivery (β = 0.02; P = 0.05) and higher concentrations among children born to β-carotene-supplemented mothers (β = 0.19; P < 0.05). At ∼9-12 years of age, thymulin was positively associated with all anthropometric measures, with height retained in our multivariate model (β = 0.02; P < 0.001). There was significant seasonal variation: concentrations tended to be lower pre-monsoon (β = -0.13; P = 0.15), during the monsoon (β = -0.22; P = 0.04), and pre-harvest (β = -0.34; P = 0.01), relative to the post-harvest season. All early-life associations, except supplementation, were mediated in part by nutritional status at follow-up. Our findings underscore the known sensitivity of the thymus to nutrition, including potentially lasting effects of early nutritional exposures. The relevance of these findings to later disease risk remains to be explored, particularly given the role of thymulin in the neuroendocrine regulation of inflammation.",2020,There was significant seasonal variation: concentrations tended to be lower pre-monsoon (β = -0.13;,"['children (n = 290; aged 9-13 years) born to participants in a cluster-randomized trial of', 'young adolescent children in rural Nepal', 'in rural Nepal (1994-1997']",['maternal vitamin A or β-carotene supplementation'],['geometric mean'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0373568', 'cui_str': 'Carotene measurement (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0260357,There was significant seasonal variation: concentrations tended to be lower pre-monsoon (β = -0.13;,"[{'ForeName': 'Amanda C', 'Initials': 'AC', 'LastName': 'Palmer', 'Affiliation': 'Department of International Health, Center for Human Nutrition, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Schulze', 'Affiliation': 'Department of International Health, Center for Human Nutrition, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.'}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'Department of International Health, Center for Human Nutrition, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.'}, {'ForeName': 'Keith P', 'Initials': 'KP', 'LastName': 'West', 'Affiliation': 'Department of International Health, Center for Human Nutrition, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.'}]",Journal of developmental origins of health and disease,['10.1017/S2040174419000485']
522,31952174,Long-Term Effect of Combination of Creatine Monohydrate Plus β-Hydroxy β-Methylbutyrate (HMB) on Exercise-Induced Muscle Damage and Anabolic/Catabolic Hormones in Elite Male Endurance Athletes.,"Creatine monohydrate (CrM) and β-hydroxy β-methylbutyrate (HMB) are widely studied ergogenic aids. However, both supplements are usually studied in an isolated manner. The few studies that have investigated the effect of combining both supplements on exercise-induced muscle damage (EIMD) and hormone status have reported controversial results. Therefore, the main purpose of this study was to determine the effect and degree of potentiation of 10 weeks of CrM plus HMB supplementation on EIMD and anabolic/catabolic hormones. This study was a double-blind, placebo-controlled trial where participants ( n  = 28) were randomized into four different groups: placebo group (PLG;  n  = 7), CrM group (CrMG; 0.04 g/kg/day of CrM;  n  = 7), HMB group (HMBG; 3 g/day of HMB;  n  = 7), and CrM-HMB group (CrM-HMBG; 0.04 g/kg/day of CrM plus 3 g/day of HMB;  n  = 7). Before (baseline, T1) and after 10 weeks of supplementation (T2), blood samples were collected from all rowers. There were no significant differences in the EIMD markers (aspartate aminotransferase, lactate dehydrogenase, and creatine kinase) among groups. However, we observed significant differences in CrM-HMBG with respect to PLG, CrMG, and HMBG on testosterone ( p  = 0.006; η 2 p = 0.454) and the testosterone/cortisol ratio (T/C;  p  = 0.032; η 2 p = 0.349). Moreover, we found a synergistic effect of combined supplementation on testosterone (CrM-HMBG = -63.85% vs. CrMG + HMBG = -37.89%) and T/C (CrM-HMBG = 680% vs. CrMG + HMBG = 57.68%) and an antagonistic effect on cortisol (CrM-HMBG = 131.55% vs. CrMG + HMBG = 389.99%). In summary, the combination of CrM plus HMB showed an increase in testosterone and T/C compared with the other groups after 10 weeks of supplementation. Moreover, this combination presented a synergistic effect on testosterone and T/C and an antagonistic effect on cortisol compared with the sum of individual or isolated supplementation.",2020,"There were no significant differences in the EIMD markers (aspartate aminotransferase, lactate dehydrogenase, and creatine kinase) among groups.","['Elite Male Endurance Athletes', 'participants ( n  = 28']","['placebo', 'CrM plus HMB supplementation', 'HMB', 'placebo group (PLG;  n  = 7), CrM', 'Creatine Monohydrate Plus β-Hydroxy β-Methylbutyrate (HMB', 'Creatine monohydrate (CrM) and β-hydroxy β-methylbutyrate (HMB', 'CrM-HMB']","['antagonistic effect on cortisol', 'testosterone and T/C', 'CrM-HMBG', 'EIMD and anabolic/catabolic hormones', 'testosterone/cortisol ratio', 'EIMD markers (aspartate aminotransferase, lactate dehydrogenase, and creatine kinase']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0873188', 'cui_str': 'Creatine Monohydrate'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0381171', 'cui_str': 'O(6)-(p-hydroxy(3H)methylbenzyl)guanine'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}]",,0.203385,"There were no significant differences in the EIMD markers (aspartate aminotransferase, lactate dehydrogenase, and creatine kinase) among groups.","[{'ForeName': 'Julen', 'Initials': 'J', 'LastName': 'Fernández-Landa', 'Affiliation': 'Laboratory of Human Performance, Department of Physical Education and Sport, Faculty of Education, Sport Section, University of the Basque Country, 01007 Vitoria, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Fernández-Lázaro', 'Affiliation': 'Department of Cellular Biology, Histology and Pharmacology. Faculty of Health Sciences, University of Valladolid. Campus de Soria, 42003 Soria, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Calleja-González', 'Affiliation': 'Laboratory of Human Performance, Department of Physical Education and Sport, Faculty of Education, Sport Section, University of the Basque Country, 01007 Vitoria, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Caballero-García', 'Affiliation': 'Department of Anatomy and Radiology. Faculty of Health Sciences, University of Valladolid, Campus de Soria, 42003 Soria, Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Córdova', 'Affiliation': 'Department of Biochemistry, Molecular Biology and Physiology, Faculty of Health Sciences, Campus de Soria, University of Valladolid, 42003 Soria, Spain.'}, {'ForeName': 'Patxi', 'Initials': 'P', 'LastName': 'León-Guereño', 'Affiliation': 'Faculty of Psychology and Education, University of Deusto, Campus of Donostia-San Sebastián, 20012 San Sebastián, Guipúzcoa, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Mielgo-Ayuso', 'Affiliation': 'Department of Biochemistry, Molecular Biology and Physiology, Faculty of Health Sciences, Campus de Soria, University of Valladolid, 42003 Soria, Spain.'}]",Biomolecules,['10.3390/biom10010140']
523,31989580,A behaviour change package to prevent hand dermatitis in nurses working in the National Health Service: results of a cluster randomized controlled trial.,"BACKGROUND


Occupational hand dermatitis poses a serious risk for nurses.
OBJECTIVES


To evaluate the clinical and cost-effectiveness of a complex intervention in reducing the prevalence of hand dermatitis in nurses METHODS: This was a cluster randomized controlled trial conducted at 35 hospital trusts, health boards or universities in the UK. Participants were (i) first-year student nurses with a history of atopic conditions or (ii) intensive care unit (ICU) nurses. Participants at intervention sites received access to a behavioural change programme plus moisturizing creams. Participants at control sites received usual care. The primary outcome was the change of prevalent dermatitis at follow-up (adjusted for baseline dermatitis) in the intervention vs. the control group. Randomization was blinded to everyone bar the trials unit to ensure allocation concealment. The trial was registered on the ISRCTN registry: ISRCTN53303171.
RESULTS


Fourteen sites were allocated to the intervention arm and 21 to the control arm. In total 2040 (69·5%) nurses consented to participate and were included in the intention-to-treat analysis. The baseline questionnaire was completed by 1727 (84·7%) participants. Overall, 789 (91·6%) ICU nurses and 938 (84·0%) student nurses returned completed questionnaires. Of these, 994 (57·6%) had photographs taken at baseline and follow-up (12-15 months). When adjusted for baseline prevalence of dermatitis and follow-up interval, the odds ratios (95% confidence intervals) for hand dermatitis at follow-up in the intervention group relative to the controls were 0·72 (0·33-1·55) and 0·62 (0·35-1·10) for student and ICU nurses, respectively. No harms were reported.
CONCLUSIONS


There was insufficient evidence to conclude whether our intervention was effective in reducing hand dermatitis in our populations.",2020,When adjusted for baseline prevalence of dermatitis and follow-up interval the odds ratio (95% confidence interval) for hand dermatitis at follow-up in the intervention group relative to the controls were 0.72 (0.33-1.55) and 0.62 (0.35-1.10) for student and ICU nurses respectively.,"['35 hospital trusts/health boards/universities in the United Kingdom', '2,040 (69.5%) nurses consented to participate and were included in the intention-to-treat analysis', 'ICU nurses and 938 (84.0%) student nurses returned completed questionnaires', 'Participants were (i) first year student nurses with a history of atopic conditions (ii) intensive care unit (ICU) nurses']","['HARM', 'behaviour change programme plus moisturising creams', 'usual care', 'complex intervention']","['hand dermatitis', 'change of prevalent dermatitis']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0392707', 'cui_str': 'Atopy (disorder)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]","[{'cui': 'C0239816', 'cui_str': 'Hand eczema (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}]",,0.106384,When adjusted for baseline prevalence of dermatitis and follow-up interval the odds ratio (95% confidence interval) for hand dermatitis at follow-up in the intervention group relative to the controls were 0.72 (0.33-1.55) and 0.62 (0.35-1.10) for student and ICU nurses respectively.,"[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Madan', 'Affiliation': ""Occupational Health Service, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, U.K.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Parsons', 'Affiliation': ""Occupational Health Service, Guy's and St Thomas' NHS Foundation Trust and King's College London, London, U.K.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Ntani', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, U.K.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Coggon', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, U.K.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': 'Centre for Behaviour Change, Department of Clinical, Educational and Health Psychology, University College London, London, U.K.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'English', 'Affiliation': 'Dermatology, Circle Nottingham NHS Treatment Centre, Nottingham, U.K.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Centre for the Economics of Mental and Physical Health, King's College London, London, U.K.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Smedley', 'Affiliation': 'Occupational Health Service, University Hospital Southampton NHS Foundation Trust, Southampton, U.K.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rushton', 'Affiliation': 'Epidemiology and Biostatistics, Imperial College London, London, U.K.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Murphy', 'Affiliation': ""King's Clinical Trial Unit, King's College London, London, U.K.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Cookson', 'Affiliation': 'Medical Microbiology, University College London, London, U.K.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Williams', 'Affiliation': 'Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, U.K.'}]",The British journal of dermatology,['10.1111/bjd.18862']
524,31496423,"Essential elements of a community empowerment approach to HIV prevention among female sex workers engaged in project Shikamana in Iringa, Tanzania.","Globally, female sex workers bear a disproportionate burden of HIV, with those in sub-Saharan Africa being among the most affected. Community empowerment approaches have proven successful at preventing HIV among this population. These approaches facilitate a process whereby sex workers take collective ownership over programmes to address the barriers they face in accessing their health and human rights. Limited applications of such approaches have been documented in Africa. We describe the community empowerment process among female sex workers in Iringa, Tanzania, in the context of a randomised controlled trial of a community empowerment-based model of combination HIV prevention. We conducted 24 in-depth interviews with participants from the intervention community and 12 key informant interviews with HIV care providers, police, venue managers, community advisory board members and research staff. Content analysis was employed, and salient themes were extracted. Findings reveal that the community empowerment process was facilitated by the meaningful engagement of sex workers in programme development, encouraging sex worker ownership over the programme, providing opportunities for solidarity and capacity building, and forming partnerships with key stakeholders. Through this process, sex workers mobilised their collective agency to access their health and human rights including HIV prevention, care and treatment.",2020,"Findings reveal that the community empowerment process was facilitated by the meaningful engagement of sex workers in programme development, encouraging sex worker ownership over the programme, providing opportunities for solidarity and capacity building, and forming partnerships with key stakeholders.","['24 in-depth interviews with participants from the intervention community and 12 key informant interviews with HIV care providers, police, venue managers, community advisory board members and research staff', 'female sex workers', 'female sex workers engaged in project Shikamana in Iringa, Tanzania']",[],[],"[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0085098', 'cui_str': 'Police'}, {'cui': 'C0335141', 'cui_str': 'Manager (occupation)'}, {'cui': 'C0035168'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0240816', 'cui_str': 'Prostitutes'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}]",[],[],,0.0818917,"Findings reveal that the community empowerment process was facilitated by the meaningful engagement of sex workers in programme development, encouraging sex worker ownership over the programme, providing opportunities for solidarity and capacity building, and forming partnerships with key stakeholders.","[{'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Leddy', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mantsios', 'Affiliation': 'Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Davis', 'Affiliation': 'Department of Sociology, American University, Washington, DC, USA.'}, {'ForeName': 'Ohvia', 'Initials': 'O', 'LastName': 'Muraleetharan', 'Affiliation': 'Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Shembilu', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.'}, {'ForeName': 'Ard', 'Initials': 'A', 'LastName': 'Mwampashi', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.'}, {'ForeName': 'S Wilson', 'Initials': 'SW', 'LastName': 'Beckham', 'Affiliation': 'Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Noya', 'Initials': 'N', 'LastName': 'Galai', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Likindikoki', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Mbwambo', 'Affiliation': 'Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Dar Es Salaam, Tanzania.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Kerrigan', 'Affiliation': 'Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]","Culture, health & sexuality",['10.1080/13691058.2019.1659999']
525,30705369,"A pilot, open labelled, randomised controlled trial of hypertonic saline nasal irrigation and gargling for the common cold.","There are no antivirals to treat viral upper respiratory tract infection (URTI). Since numerous viruses cause URTI, antiviral therapy is impractical. As we have evidence of chloride-ion dependent innate antiviral response in epithelial cells, we conducted a pilot, non-blinded, randomised controlled trial of hypertonic saline nasal irrigation and gargling (HSNIG) vs standard care on healthy adults within 48 hours of URTI onset to assess recruitment (primary outcome). Acceptability, symptom duration and viral shedding were secondary outcomes. Participants maintained a symptom diary until well for two days or a maximum of 14 days and collected 5 sequential mid-turbinate swabs to measure viral shedding. The intervention arm prepared hypertonic saline and performed HSNIG. We recruited 68 participants (2.6 participants/week; November 2014-March 2015). A participant declined after randomisation. Another was on antibiotics and hence removed (Intervention:32, Control:34). Follow up data was available from 61 (Intervention:30, Control:31). 87% found HSNIG acceptable, 93% thought HSNIG made a difference to their symptoms. In the intervention arm, duration of illness was lower by 1.9 days (p = 0.01), over-the-counter medications (OTCM) use by 36% (p = 0.004), transmission within household contacts by 35% (p = 0.006) and viral shedding by ≥0.5 log 10 /day (p = 0.04). We hence need a larger trial to confirm our findings.",2019,"In the intervention arm, duration of illness was lower by 1.9 days (p = 0.01), over-the-counter medications (OTCM) use by 36% (p = 0.004), transmission within household contacts by 35% (p = 0.006) and viral shedding by ≥0.5 log 10 /day (p = 0.04).","['healthy adults within 48\u2009hours of URTI onset to assess recruitment (primary outcome', '68 participants (2.6 participants/week; November 2014-March 2015']","['hypertonic saline nasal irrigation', 'hypertonic saline and performed HSNIG', 'hypertonic saline nasal irrigation and gargling (HSNIG) vs standard care']","['viral shedding', 'duration of illness', 'transmission within household contacts', 'Acceptability, symptom duration and viral shedding']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4517633', 'cui_str': 'Two point six'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C2350442', 'cui_str': 'Nasal Irrigation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0162633', 'cui_str': 'Viral Shedding'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",68.0,0.186193,"In the intervention arm, duration of illness was lower by 1.9 days (p = 0.01), over-the-counter medications (OTCM) use by 36% (p = 0.004), transmission within household contacts by 35% (p = 0.006) and viral shedding by ≥0.5 log 10 /day (p = 0.04).","[{'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Ramalingam', 'Affiliation': 'Department of Laboratory Medicine, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SA, UK. sandeep.ramalingam@nhslothian.scot.nhs.uk.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Graham', 'Affiliation': 'Wellcome Trust Clinical Research Facility, University of Edinburgh, Western General Hospital, Crewe Road South, Edinburgh, EH4 2XU, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Dove', 'Affiliation': 'Department of Laboratory Medicine, Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SA, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Morrice', 'Affiliation': 'Centre of Medical Informatics, Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Medical School Doorway 3, Teviot Place, Edinburgh, EH8 9AG, UK.'}, {'ForeName': 'Aziz', 'Initials': 'A', 'LastName': 'Sheikh', 'Affiliation': 'Centre of Medical Informatics, Usher Institute of Population Health Sciences and Informatics, The University of Edinburgh, Medical School Doorway 3, Teviot Place, Edinburgh, EH8 9AG, UK.'}]",Scientific reports,['10.1038/s41598-018-37703-3']
526,31676719,Delivery of long-term-injectable agents for TB by lay carers: pragmatic randomised trial.,"BACKGROUND


People with recurrent or drug-resistant TB require long courses of intramuscular injections. We evaluate a novel system in which patient-nominated lay carers were trained to deliver intramuscular injections to patients in their own homes.
METHODS


A pragmatic, individually randomised non-inferiority trial was conducted at two hospitals in Malawi. Adults starting TB retreatment were recruited. Patients randomised to the intervention received home-based care from patient-nominated lay people trained to deliver intramuscular streptomycin. Patients receiving standard care were admitted to hospital for 2 months of streptomycin. The primary outcome was successful treatment (alive and on treatment) at the end of the intervention.
RESULTS


Of 456 patients screened, 204 participants were randomised. The trial was terminated early due to futility. At the end of the intervention, 97/101 (96.0%) in the hospital arm were still alive and on treatment compared with 96/103 (93.2%) in the home-based arm (risk difference -0.03 (95% CI -0.09 to 0.03); p value 0.538). There were no differences in the proportion completing 8 months of anti-TB treatment; or the proportion experiencing 2-month sputum culture conversion. The mean cost of hospital-based management was US$1546.3 per person, compared to US$729.2 for home-based management. Home-based care reduced risk of catastrophic household costs by 84%.
CONCLUSIONS


Although this trial failed to meet target recruitment, the available data demonstrate that training patient-nominated lay people has potential to provide a feasible solution to the operational challenges associated with delivering long-term-injectable drugs to people with recurrent or drug-resistant TB in resource-limited settings, and substantially reduce costs. Further data under operational conditions are required.
TRIAL REGISTRATION NUMBER


ISRCTN05815615.",2020,"The mean cost of hospital-based management was US$1546.3 per person, compared to US$729.2 for home-based management.","['TB by lay carers', 'People with recurrent or drug-resistant TB require long courses of intramuscular injections', 'Patients receiving standard care were admitted to hospital for 2\u2009months of streptomycin', '456 patients screened, 204 participants were randomised', 'patient-nominated lay carers', 'two hospitals in Malawi', 'Adults starting TB retreatment were recruited']",['home-based care from patient-nominated lay people trained to deliver intramuscular streptomycin'],"['successful treatment (alive and on treatment', 'mean cost of hospital-based management']","[{'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038425', 'cui_str': 'Streptomycin'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0038425', 'cui_str': 'Streptomycin'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",204.0,0.212781,"The mean cost of hospital-based management was US$1546.3 per person, compared to US$729.2 for home-based management.","[{'ForeName': 'Danielle B', 'Initials': 'DB', 'LastName': 'Cohen', 'Affiliation': 'Infection, Immunity & Cardiovascular Disease, University of Sheffield, Sheffield, UK Danielle.Cohen@sheffield.ac.uk.'}, {'ForeName': 'Kuzani', 'Initials': 'K', 'LastName': 'Mbendera', 'Affiliation': 'Malawi National TB Programme, Lilongwe, Malawi.'}, {'ForeName': 'Hendramoorthy', 'Initials': 'H', 'LastName': 'Maheswaran', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Mavuto', 'Initials': 'M', 'LastName': 'Mukaka', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mangochi', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Phiri', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Madan', 'Affiliation': 'Division of Health Sciences, University of Warwick, Warwick, UK.'}, {'ForeName': 'Geraint', 'Initials': 'G', 'LastName': 'Davies', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Corbett', 'Affiliation': 'Clinical Department, Malawi Liverpool Wellcome Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'Bertel', 'Initials': 'B', 'LastName': 'Squire', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.'}]",Thorax,['10.1136/thoraxjnl-2018-212675']
527,32095558,Linking CHHiP prostate cancer RCT with GP records: A study proposal to investigate the effect of co-morbidities and medications on long-term symptoms and radiotherapy-related toxicity.,"Background


Patients receiving cancer treatment often have one or more co-morbid conditions that are treated pharmacologically. Co-morbidities are recorded in clinical trials usually only at baseline. However, co-morbidities evolve and new ones emerge during cancer treatment. The interaction between multi-morbidity and cancer recovery is significant but poorly understood.
Purpose


To investigate the effect of co-morbidities (e.g. cardiovascular and diabetes) and medications (e.g. statins, antihypertensives, metformin) on radiotherapy-related toxicity and long-term symptoms in order to identify potential risk factors. The possible protective effect of medications such as statins or antihypertensives in reducing radiotherapy-related toxicity will also be explored.
Methods


Two datasets will be linked. (1) CHHiP (Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer) randomised control trial. CHHiP contains pelvic symptoms and radiation-related toxicity reported by patients and clinicians. (2) GP (General Practice) data from RCGP RSC (Royal College of General Practitioners Research and Surveillance Centre). The GP records of CHHiP patients will be extracted, including cardiovascular co-morbidities, diabetes and prescription medications. Statistical analysis of the combined dataset will be performed in order to investigate the effect.
Conclusions


Linking two sources of healthcare data is an exciting area of big healthcare data research. With limited data in clinical trials (not all clinical trials collect information on co-morbidities or medications) and limited lengths of follow-up, linking different sources of information is increasingly needed to investigate long-term outcomes. With increasing pressures to collect detailed information in clinical trials (e.g. co-morbidities, medications), linkage to routinely collected data offers the potential to support efficient conduct of clinical trials.",2017,Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer) randomised control trial.,['Linking CHHiP prostate cancer RCT with GP records'],"['Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy', 'medications (e.g. statins, antihypertensives, metformin', 'CHHiP', 'CHHiP ']",[],"[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C1512814', 'cui_str': 'Radiotherapy, Intensity-Modulated'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]",[],2.0,0.115421,Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy for Prostate Cancer) randomised control trial.,"[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Lemanska', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Byford', 'Affiliation': 'Department of Health Care Management and Policy, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Correa', 'Affiliation': 'Department of Health Care Management and Policy, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Cruickshank', 'Affiliation': 'The Institute of Cancer Research - Clinical Trials and Statistics Unit, London, UK.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'The Institute of Cancer Research and Royal Marsden NHS Trust, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Griffin', 'Affiliation': 'The Institute of Cancer Research - Clinical Trials and Statistics Unit, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'The Institute of Cancer Research - Clinical Trials and Statistics Unit, London, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'de Lusignan', 'Affiliation': 'Department of Health Care Management and Policy, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Faithfull', 'Affiliation': 'School of Health Sciences, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}]",Technical innovations & patient support in radiation oncology,['10.1016/j.tipsro.2017.06.001']
528,32097051,"Relationship between Symptoms, Exacerbations, and Treatment Response in Bronchiectasis.","Rationale:  Bronchiectasis guidelines regard treatment to prevent exacerbation and treatment of daily symptoms as separate objectives. Objectives:  We hypothesized that patients with greater symptoms would be at higher risk of exacerbations and therefore that a treatment aimed at reducing daily symptoms would also reduce exacerbations in highly symptomatic patients. Methods:  Our study comprised an observational cohort of 333 patients from the East of Scotland (2012-2016). Either symptoms were modeled as a continuous variable or patients were classified as having high, moderate, or low symptom burden (>70, 40-70, and <40 using the St. George's Respiratory Questionnaire symptom score). The hypothesis that exacerbation reductions would only be evident in highly symptomatic patients was tested in a  post hoc  analysis of a randomized trial of inhaled dry powder mannitol ( N  = 461 patients). Measurements and Main Results:  In the observational cohort, daily symptoms were a significant predictor of future exacerbations (rate ratio [RR], 1.10; 95% confidence interval [CI], 1.03-1.17;  P  = 0.005). Patients with higher symptom scores had higher exacerbation rates (RR, 1.74; 95% CI, 1.12-2.72;  P  = 0.01) over 12-month follow-up than those with lower symptoms. Inhaled mannitol treatment improved the time to first exacerbation (hazard ratio, 0.56; 95% CI, 0.40-0.77;  P  < 0.001), and the proportion of patients remaining exacerbation free for 12 months of treatment was higher in the mannitol group (32.7% vs. 14.6%; RR, 2.84; 95% CI, 1.40-5.76;  P  = 0.003), but only in highly symptomatic patients. In contrast, no benefit was evident in patients with lower symptom burden. Conclusions:  Highly symptomatic patients have increased risk of exacerbations, and exacerbation benefit with inhaled mannitol was only evident in patients with high symptom burden.",2020,"Patients with high symptom scores had higher exacerbation rates (RR 1.74, 95% CI 1.12-2.72,P=0.01) over 12 months follow-up compared to those with lower symptoms.","['N=461 patients) Measurement and Main Results', '333 patients from the East of Scotland(2012-2016', 'patients with greater symptoms']","['inhaled mannitol', 'Inhaled mannitol']","['risk of exacerbations, and exacerbation benefit', 'proportion of patients remaining exacerbation free', 'exacerbation rates', 'time to first exacerbation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4517724', 'cui_str': 'Three hundred and thirty-three'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",333.0,0.663845,"Patients with high symptom scores had higher exacerbation rates (RR 1.74, 95% CI 1.12-2.72,P=0.01) over 12 months follow-up compared to those with lower symptoms.","[{'ForeName': 'Yong-Hua', 'Initials': 'YH', 'LastName': 'Gao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Abo Leyah', 'Affiliation': 'Scottish Centre for Respiratory Medicine, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Finch', 'Affiliation': 'Scottish Centre for Respiratory Medicine, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Lonergan', 'Affiliation': 'Scottish Centre for Respiratory Medicine, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Aliberti', 'Affiliation': 'Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'De Soyza', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom; and.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Fardon', 'Affiliation': 'Scottish Centre for Respiratory Medicine, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Tino', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Chalmers', 'Affiliation': 'Scottish Centre for Respiratory Medicine, University of Dundee, Dundee, United Kingdom.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201910-1972OC']
529,32160043,EFFECT OF GLUTEN-FREE DIET ON METABOLIC CONTROL AND ANTHROPOMETRIC PARAMETERS IN TYPE 1 DIABETES WITH SUBCLINICAL CELIAC DISEASE: A RANDOMIZED CONTROLLED TRIAL.,"Objective:  It is unclear whether the institution of gluten-free diet (GFD) is beneficial in patients with type 1 diabetes (T1DM) and subclinical celiac disease (CD). Our primary objective was to evaluate the effect of GFD on the frequency of hypoglycemia, in patients with T1DM and subclinical CD. Our secondary objective was to investigate the effect of GFD on height, weight, glycosylated hemoglobin (HbA1c), insulin dose requirement, and bone mineral homeostasis.  Methods:  We carried out a prospective open label randomized controlled trial (RCT). Patients with T1DM and subclinical CD were randomized to receive GFD or a normal diet for 1 year. The primary outcome was the frequency of hypoglycemic episodes (blood glucose <70 mg/dL) measured by self-monitoring of blood glucose (SMBG) at the sixth month of the study in the 2 groups.  Results:  Screening for CD was carried out in 320 T1DM patients. Thirty eligible patients were randomized to receive GFD (n = 15) or a normal diet (n = 15). The mean number of hypoglycemic episodes/month recorded by SMBG and the mean time spent in hypoglycemia measured by CGM (minutes) in the GFD group versus the non-GFD group at six months was 2.3 minutes versus 3.4 minutes ( P  = .5) and 124.1 minutes versus 356.9 minutes ( P  = .1), respectively. The mean number of hypoglycemic episodes/month significantly declined in the GFD group (3.5 episodes at baseline versus 2.3 episodes at the sixth month;  P  = .03). The mean HbA1c declined by 0.73% in the GFD group and rose by 0.99% in non-GFD group at study completion.  Conclusion:  This is the first RCT to assess the effect of GFD in T1DM and subclinical CD. A trend towards a decrease in hypoglycemic episodes and better glycemic control was seen in patients receiving GFD.  Abbreviations: BMC  = bone mineral content;  BMI  = body mass index;  CD  = celiac disease;  CGM  = continuous glucose monitoring;  GFD  = gluten-free diet;  Hb  = hemoglobin;  HbA1c  = glycosylated hemoglobin;  iPTH  = intact parathyroid hormone;  RCT  = randomized controlled trial;  SMBG  = self-monitoring of blood glucose;  T1DM  = type 1 diabetes mellitus;  tTG-IgA  = tissue transglutaminase immunoglobulin A.",2020,"Mean HbA1c declined by 0.73% in GFD group and rose by 0.99% in non GFD group, at study completion.
","['patients with type 1 diabetes (T1DM) and subclinical celiac disease (CD', '30 eligible patients', '320 T1DM patients were screened for CD', 'patients with T1DM and subclinical CD', 'Patients with T1DM and subclinical CD']","['GFD', 'gluten free diet (GFD', 'normal diet']","['Mean number of hypoglycemic episodes/month recorded by SMBG and mean time spent in hypoglycemia', 'Mean HbA1c', 'height, weight, glycosylated hemoglobin (HbA1c), insulin dose requirement and bone mineral homeostasis', 'Mean number of hypoglycemic episodes', 'hypoglycemic episodes and better glycemic control', 'frequency of hypoglycemia', 'frequency of hypoglycemic episodes (blood glucose< 70 mg/dl) measured by self-monitoring of blood glucose (SMBG']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]","[{'cui': 'C0344351', 'cui_str': 'Gluten-Free Diet'}, {'cui': 'C0184625', 'cui_str': 'Regular diet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycemic attack'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005803', 'cui_str': 'Monitoring, Home Blood Glucose'}]",30.0,0.0696382,"Mean HbA1c declined by 0.73% in GFD group and rose by 0.99% in non GFD group, at study completion.
","[{'ForeName': 'Parjeet', 'Initials': 'P', 'LastName': 'Kaur', 'Affiliation': ''}, {'ForeName': 'Anuja', 'Initials': 'A', 'LastName': 'Agarwala', 'Affiliation': ''}, {'ForeName': 'Govind', 'Initials': 'G', 'LastName': 'Makharia', 'Affiliation': ''}, {'ForeName': 'Shinjini', 'Initials': 'S', 'LastName': 'Bhatnagar', 'Affiliation': ''}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': ''}]",Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists,['10.4158/EP-2019-0479']
530,30480877,Hypothalamic-pituitary-adrenal axis differentially responses to morning and evening psychological stress in healthy subjects.,"AIM


The hypothalamic-pituitary-adrenal (HPA) axis responds to changing environmental demands including psychological stressors. The aim of the present study was to assess whether the time of day effects on the acute response of HPA axis activity to acute psychological stress.
METHOD


We studied 27 healthy young subjects. The subjects were participated two experiments as follows. In the first experiment, subjects were instructed to keep their regular sleep schedule for 2 weeks which were measured by using a wrist-worn activity monitor. Afterward, to evaluate a diurnal rhythm of salivary cortisol, eight saliva samples were collected during waking period every 2 hours from when the subjects woke up. In the second experiment, the subjects were randomly assigned to two groups. The Trier Social Stress Test (TSST) was performed either in the morning (n = 14) or in the evening (n = 13). We measured diurnal rhythm of salivary cortisol and stress response of salivary cortisol and heart rate by the TSST. Morning and evening tests were started at 2 hours and 10 hours after woke up, respectively.
RESULTS


All subjects showed a normal diurnal rhythm of salivary cortisol concentration, with a peak in the morning immediately after awaking and a minimum in the evening. The salivary cortisol response after the TSST was significantly increased from the prestress level in the morning but not in the evening.
CONCLUSION


The HPA response to acute psychological stress was more pronounced in the morning than in the evening, correlating with the circadian regulation of cortisol synthesis.",2019,"The HPA response to acute psychological stress was more pronounced in the morning than in the evening, correlating with the circadian regulation of cortisol synthesis.","['27 healthy young subjects', 'healthy subjects']",[],"['salivary cortisol response', 'diurnal rhythm of salivary cortisol, eight saliva samples', 'normal diurnal rhythm of salivary cortisol concentration', 'diurnal rhythm of salivary cortisol and stress response of salivary cortisol and heart rate', 'Trier Social Stress Test (TSST', 'HPA response to acute psychological stress']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],"[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C4255064', 'cui_str': 'Diurnal Rhythm'}, {'cui': 'C0036087', 'cui_str': 'Saliva (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C0038443', 'cui_str': 'Stressor, Psychological'}]",27.0,0.0155626,"The HPA response to acute psychological stress was more pronounced in the morning than in the evening, correlating with the circadian regulation of cortisol synthesis.","[{'ForeName': 'Yujiro', 'Initials': 'Y', 'LastName': 'Yamanaka', 'Affiliation': 'Laboratory of Life & Health Sciences, Graduate School of Education, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Hidemasa', 'Initials': 'H', 'LastName': 'Motoshima', 'Affiliation': 'Research Center, Yotsuba Milk Products Co., Ltd, Kitahiroshima, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Uchida', 'Affiliation': 'Research Center, Yotsuba Milk Products Co., Ltd, Kitahiroshima, Japan.'}]",Neuropsychopharmacology reports,['10.1002/npr2.12042']
531,30665714,Impact of baseline early auditory processing on response to cognitive remediation for schizophrenia.,"BACKGROUND


Early auditory processing (EAP) has increasingly become a focus of efforts to identify biomarkers of treatment response in schizophrenia. EAP deficits lead to poor functional outcome via impaired cognition, and treatments that target EAP may drive downstream cognitive improvements. Assessment of baseline need provides an opportunity for cognitive remediation (CR) programs that give EAP training to personalize treatment and optimize its impact. This initial efficacy study examined the differential benefit of EAP training for those with and without baseline EAP deficits as defined by performance on the Tone Matching Test.
METHODS


103 outpatient adults diagnosed with schizophrenia or schizoaffective disorder were classified as having intact (48.5%) or impaired (51.5%) EAP and randomized to a CR program with restorative exercise plans that either included EAP training (N = 49) or did not (N = 54). Cognitive and functional outcomes were measured post-treatment and 3 months later.
RESULTS


Only in EAP impaired participants was there a significant benefit from EAP training on verbal learning. Treatment condition did not significantly impact global cognitive or functional outcomes for either EAP group. Cognitive gains partially mediated the relationship between gains in EAP and functional capacity.
CONCLUSION


These findings support the importance of addressing basic auditory deficits when attempting to remediate higher order auditory impairments such as verbal learning. In addition, they highlight the need for routine assessment of EAP in cognitive remediation participants, as well as the need for more effective programs to reverse these impairments.",2019,Treatment condition did not significantly impact global cognitive or functional outcomes for either EAP group.,"['103 outpatient adults diagnosed with schizophrenia or schizoaffective disorder were classified as having intact (48.5%) or impaired (51.5%) EAP and randomized to a', 'schizophrenia']","['CR program with restorative exercise plans that either included EAP training (N\u202f=\u202f49) or did not (N\u202f=\u202f54', 'baseline early auditory processing', 'EAP training', 'Early auditory processing (EAP']","['impact global cognitive or functional outcomes', 'Cognitive and functional outcomes', 'verbal learning']","[{'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}]","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}]",103.0,0.0333335,Treatment condition did not significantly impact global cognitive or functional outcomes for either EAP group.,"[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Medalia', 'Affiliation': 'New York State Psychiatric Institute, Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons and New York Presbyterian, New York, NY 10032, USA. Electronic address: Alice.Medalia@columbia.edu.'}, {'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Saperstein', 'Affiliation': 'Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, NY 10032, USA. Electronic address: Alice.Saperstein@nyspi.columbia.edu.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Qian', 'Affiliation': 'Columbia University Mailman School of Public Health, Department of Biostatistics, New York, NY 10032, USA. Electronic address: mq2158@cumc.columbia.edu.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Javitt', 'Affiliation': 'New York State Psychiatric Institute, Department of Psychiatry, Columbia University Vagelos College of Physicians and Surgeons, New York, NY 10032, USA. Electronic address: dcj2113@cumc.columbia.edu.'}]",Schizophrenia research,['10.1016/j.schres.2019.01.012']
532,32147464,How Does Cadaveric Simulation Influence Learning in Orthopedic Residents?,"OBJECTIVE


The objectives of this study were to understand how cadaveric simulation impacts learning in orthopedic residents, why it is a useful training tool, and how skills learnt in the simulated environment translate into the workplace.
DESIGN


This is a qualitative research study using in-depth, semistructured interviews with orthopedic residents who underwent an intensive cadaveric simulation training course.
SETTING


The study was conducted at the University Hospital Coventry & Warwickshire, a tertiary care center with integrated cadaveric training laboratory in England, United Kingdom.
PARTICIPANTS


Orthopedic surgery residents in the intervention group of a randomized controlled trial comparing intensive cadaveric simulation training with standard ""on the job"" training were invited to participate. Eleven of 14 eligible residents were interviewed (PGY 3-6, 8 male and 3 female).
RESULTS


Learning from cadaveric simulation can be broadly categorized into intrinsic, surgeon-driven factors, and extrinsic environmental factors. Intrinsic factors include participant ability to ""buy-in"" to the simulation exercise, willingness to push one's own learning boundaries in a ""safe space"" and take out on resident experience and self-reported confidence, with the greatest learning gains seen at around the PGY4 stage in individuals who reported low preintervention operative confidence. Extrinsic factors included; the opportunity to perform operations in their entirety without external pressures or attending ""take-over,"" leading to subjective improvement in participant operative fluency and confidence. The intensive supervision of subspecialist attending surgeons giving real-time performance feedback, tips and tricks, and the opportunity to practice unusual approaches was highly valued by participants, as was paired learning with alternating roles as primary surgeon/assistant and multidisciplinary involvement of scrub-staff and radiographers. Cadaveric simulation added educational value beyond that obtained in low-fidelity simulation training by ""stirring into practice"" and ""becoming through doing."" In providing ultrarealistic representation of the space, ritualism, and costuming of the operating theater, cadaveric simulation training also enabled the development of a range of nontechnical skills and sociocultural ""nontechnical"" lessons of surgery.
CONCLUSIONS


Cadaveric simulation enhances learning in both technical and nontechnical skills in junior orthopedic residents within a single training package. Direct transfer of skills learnt in the simulation training to the real-world operating theater, with consequent patient benefit, was reported. Cadaveric simulation in the UK training system of orthopedics may be of greatest utility at around the PGY 4 stage, at which point operative fluency, independence, and confidence can be rapidly improved in the cadaveric laboratory, to enable the attainment of competence in index trauma operations.",2020,"Cadaveric simulation added educational value beyond that obtained in low-fidelity simulation training by ""stirring into practice"" and ""becoming through doing.""","['orthopedic residents', 'The study was conducted at the University Hospital Coventry & Warwickshire, a tertiary care center with integrated cadaveric training laboratory in England, United Kingdom', 'Orthopedic Residents', 'Orthopedic surgery residents', 'junior orthopedic residents within a single training package', 'orthopedic residents who underwent an intensive cadaveric simulation training course', 'Eleven of 14 eligible residents were interviewed (PGY 3-6, 8 male and 3 female']","['intensive cadaveric simulation training with standard ""on the job"" training', 'Cadaveric simulation enhances learning']",[],"[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0454881', 'cui_str': 'Warwickshire (geographic location)'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0162439', 'cui_str': 'Orthopedic Surgery'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1704710', 'cui_str': 'Package'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",[],,0.0382994,"Cadaveric simulation added educational value beyond that obtained in low-fidelity simulation training by ""stirring into practice"" and ""becoming through doing.""","[{'ForeName': 'Hannah K', 'Initials': 'HK', 'LastName': 'James', 'Affiliation': 'Clinical Trials Unit, Warwick Medical School, Coventry, United Kingdom; Department of Trauma and Orthopaedic Surgery, University Hospitals Coventry and Warwickshire, Coventry, United Kingdom. Electronic address: H.Smith.1@warwick.ac.uk.'}, {'ForeName': 'Giles T R', 'Initials': 'GTR', 'LastName': 'Pattison', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University Hospitals Coventry and Warwickshire, Coventry, United Kingdom.'}, {'ForeName': 'Damian R', 'Initials': 'DR', 'LastName': 'Griffin', 'Affiliation': 'Clinical Trials Unit, Warwick Medical School, Coventry, United Kingdom; Department of Trauma and Orthopaedic Surgery, University Hospitals Coventry and Warwickshire, Coventry, United Kingdom.'}, {'ForeName': 'Joanne D', 'Initials': 'JD', 'LastName': 'Fisher', 'Affiliation': 'Clinical Trials Unit, Warwick Medical School, Coventry, United Kingdom.'}]",Journal of surgical education,['10.1016/j.jsurg.2019.12.006']
533,31811339,Randomized Controlled Trial on Autologous Platelet-Rich Plasma Versus Saline Dressing in Treatment of Non-healing Diabetic Foot Ulcers.,"BACKGROUND


This randomized clinical trial was conducted to assess the role of platelet-rich plasma (PRP) gel as a treatment of clean non-healing diabetic foot ulcer (DFU) in comparison with regular dressing with saline as a control.
METHODS


Patients with DFU were randomly assigned to one of two equal groups: group I received dressing with PRP gel and group II received regular saline dressing. The main outcomes of the study were percent reduction in the dimensions of the DFU, healing of DFU, and complications at 20 weeks of follow-up.
RESULTS


Twenty-four patients were included to the study. The mean age of patients was 55.2 ± 6.4 years. Only three (25%) patients in group I achieved complete healing versus none of group II patients. In total, 8.3% of group I and 41.6% of group II patients did not show any response to treatment. The percent of reduction in the longitudinal and horizontal dimensions of the DFU was significantly greater in group I than group II (43.2% vs 4.1%) and (42.3% vs 8.2%), respectively. The time required to maximum healing was significantly shorter in group I than group II (6.3 ± 2.1 vs 10.4 ± 1.7 weeks, P < 0.0001).
CONCLUSION


The use of PRP gel as a dressing for chronic DFU resulted in a more significant reduction in the size of the ulcer when compared to regular saline dressing. Also the time to reach the point of maximal possible healing with the least wound dimensions was significantly shorter when using PRP as a dressing protocol.",2020,"The time required to maximum healing was significantly shorter in group I than group II (6.3 ± 2.1 vs 10.4 ± 1.7 weeks, P < 0.0001).
","['Non-healing Diabetic Foot Ulcers', 'Twenty-four patients were included to the study', 'The mean age of patients was 55.2\u2009±\u20096.4\xa0years', 'Patients with DFU', 'clean non-healing diabetic foot ulcer (DFU']","['Autologous Platelet-Rich Plasma Versus Saline Dressing', 'dressing with PRP gel and group II received regular saline dressing', 'platelet-rich plasma (PRP) gel', 'PRP gel']","['complete healing', 'dimensions of the DFU, healing of DFU, and complications', 'time required to maximum healing', 'longitudinal and horizontal dimensions of the DFU']","[{'cui': 'C0205301', 'cui_str': 'Non-healed (qualifier value)'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0013119', 'cui_str': 'Dressings'}, {'cui': 'C4321376', 'cui_str': 'Dressing'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}]",24.0,0.0324557,"The time required to maximum healing was significantly shorter in group I than group II (6.3 ± 2.1 vs 10.4 ± 1.7 weeks, P < 0.0001).
","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elsaid', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, PO: 35516, Mansoura, Egypt.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'El-Said', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, PO: 35516, Mansoura, Egypt.'}, {'ForeName': 'Sameh', 'Initials': 'S', 'LastName': 'Emile', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, PO: 35516, Mansoura, Egypt. sameh200@hotmail.com.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Youssef', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, PO: 35516, Mansoura, Egypt.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Khafagy', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, PO: 35516, Mansoura, Egypt.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Elshobaky', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, PO: 35516, Mansoura, Egypt.'}]",World journal of surgery,['10.1007/s00268-019-05316-0']
534,31818716,Evaluation of the management of pretreatment HIV drug resistance by oligonucleotide ligation assay: a randomised controlled trial.,"BACKGROUND


Although experts have recommended testing for pretreatment drug resistance (PDR) before antiretroviral therapy (ART) initiation, there is little evidence to support its implementation. We aimed to establish whether an inexpensive point mutation assay can improve virological suppression by identifying PDR to guide drug selection for ART in a lower-middle income country.
METHODS


Investigators did an open-label, randomised controlled trial at three HIV treatment sites in Kenya: two in Nairobi and one in rural Maseno. Individuals (aged ≥2 years) were eligible to participate if they were confirmed HIV-seropositive, qualified for first-line ART, planned to reside in the area for more than 1 year, and provided informed consent. We randomly assigned participants (1:1) to either PDR testing by oligonucleotide ligation assay (OLA) to guide selection of ART or to standard of care, which did not include OLA testing. The OLA-guided therapy group had pre-ART peripheral blood mononuclear cells evaluated for drug resistance to non-nucleoside reverse transcriptase inhibitor (NNRTI) at codons Lys103Asn, Tyr181Cys, Gly190Ala, and to lamivudine at Met184Val, and when at least one drug-resistant codon was detected in a participant's pre-ART specimen, clinicians were directed to prescribe protease inhibitor-based second-line ART. Those without detected resistance and those who were randomised to standard of care received NNRTI-based first-line ART. The primary outcome was plasma HIV-1 RNA of at least 400 copies per mL at 4, 8, or 12 months after ART initiation, which defined virological failure, assessed in all participants who received treatment (data were censored for those lost-to-follow-up or who died). The study has been completed and is registered with ClinicalTrials.gov, NCT01898754.
FINDINGS


We screened 1198 participants between May 28, 2013, and Nov 4, 2014, of whom 991 (83%) were enrolled (492 received OLA and 495 received standard of care; four did not begin treatment). 93 participants (prevalence 9·4%) had PDR (95% CI 7·7-11·4). 34 (8·5%) of 400 participants in the OLA group had virological failure at month 12 of ART (95% CI 6·0-11·7) compared with 39 (9·7%) of 402 (7·0-13·0) in the standard-of-care group (log-rank p=0·26). Among participants with PDR, virological failure was lower in the OLA-guided therapy group than in the standard-of-care group: five (14%) of 35 compared with 13 (50%) of 26; p=0·0020). Among those prescribed NNRTI-based ART, participants given efavirenz were less likely to have virological failure than were those receiving nevirapine (odds ratio 0·37, 95% CI 0·22-0·62; p<0·0001). The OLA-guided therapy group had 39 serious non-lethal adverse events and 34 deaths. The standard-of-care group had 34 severe adverse events and 43 deaths, differences that were not significant. Adverse events judged to potentially be due to ART were few and similar between groups, with 17 (16%) in the OLA-guided therapy group and 16 (16%) in the standard-of-care group (p=0·90).
INTERPRETATION


Our finding that OLA testing for PDR reduced virological failure in only those with specific PDR mutations suggests that PDR poses less of a risk for virological failure than that predicted by past prevalence estimates, and that the value of PDR testing to reduce virological failure should be assessed for antiretroviral treatment regimens.
FUNDING


US National Institutes of Health.",2020,34 (8·5%) of 400 participants in the OLA group had virological failure at month 12 of ART (95% CI 6·0-11·7) compared with 39 (9·7%) of 402 (7·0-13·0) in the standard-of-care group,"['Kenya: two in Nairobi and one in rural Maseno', 'Individuals (aged ≥2 years) were eligible to participate if they were confirmed HIV-seropositive, qualified for first-line ART, planned to reside in the area for more than 1 year, and provided informed consent', '1198 participants between May 28, 2013, and Nov 4, 2014, of whom 991 (83%) were enrolled (492 received OLA and 495 received standard of care; four did not begin treatment']","['OLA', 'oligonucleotide ligation assay', 'efavirenz', 'nevirapine', 'PDR testing by oligonucleotide ligation assay']","['virological failure', 'virological suppression', 'PDR', 'plasma HIV-1 RNA']","[{'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0028953', 'cui_str': 'Oligonucleotides'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0132326', 'cui_str': 'Nevirapine'}]","[{'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}]",93.0,0.302286,34 (8·5%) of 400 participants in the OLA group had virological failure at month 12 of ART (95% CI 6·0-11·7) compared with 39 (9·7%) of 402 (7·0-13·0) in the standard-of-care group,"[{'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Chung', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA; Department of Medicine, University of Washington, Seattle, WA, USA; Department of Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Christine J', 'Initials': 'CJ', 'LastName': 'McGrath', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Ingrid A', 'Initials': 'IA', 'LastName': 'Beck', 'Affiliation': ""Seattle Children's Research Institute, University of Washington, Seattle, WA, USA.""}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Levine', 'Affiliation': ""Seattle Children's Research Institute, University of Washington, Seattle, WA, USA.""}, {'ForeName': 'Ross S', 'Initials': 'RS', 'LastName': 'Milne', 'Affiliation': ""Seattle Children's Research Institute, University of Washington, Seattle, WA, USA.""}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'So', 'Affiliation': ""Seattle Children's Research Institute, University of Washington, Seattle, WA, USA.""}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Andersen', 'Affiliation': ""Seattle Children's Research Institute, University of Washington, Seattle, WA, USA.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Dross', 'Affiliation': ""Department of Global Health, University of Washington, Seattle, WA, USA; Seattle Children's Research Institute, University of Washington, Seattle, WA, USA.""}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Coombs', 'Affiliation': 'Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Bhavna', 'Initials': 'B', 'LastName': 'Chohan', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Yatich', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kiptinness', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Samah R', 'Initials': 'SR', 'LastName': 'Sakr', 'Affiliation': 'Coptic Hospital, Nairobi, Kenya.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Kiarie', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Frenkel', 'Affiliation': ""Department of Global Health, University of Washington, Seattle, WA, USA; Department of Laboratory Medicine, University of Washington, Seattle, WA, USA; Department of Pediatrics, University of Washington, Seattle, WA, USA; Seattle Children's Research Institute, University of Washington, Seattle, WA, USA. Electronic address: lfrenkel@u.washington.edu.""}]",The lancet. HIV,['10.1016/S2352-3018(19)30337-6']
535,31777008,Cost-Effectiveness of Sertraline in Primary Care According to Initial Severity and Duration of Depressive Symptoms: Findings from the PANDA RCT.,"BACKGROUND


Antidepressants are commonly prescribed for depression, but it is unclear whether treatment efficacy depends on severity and duration of symptoms and how prescribing might be targeted cost-effectively.
OBJECTIVES


We investigated the cost-effectiveness of the antidepressant sertraline compared with placebo in subgroups defined by severity and duration of depressive symptoms.
METHODS


We undertook a cost-effectiveness analysis from the perspective of the NHS and Personal and Social Services (PSS) in the UK alongside the PANDA (What are the indications for Prescribing ANtiDepressants that will leAd to a clinical benefit?) randomised controlled trial (RCT), which compared sertraline with placebo over a 12-week period. Quality of life data were collected at baseline and at 2, 6, and 12 weeks post-randomisation using EQ-5D-5L, from which we calculated quality-adjusted life years (QALYs). Costs (in 2017/18£) were collected using patient records and from resource use questionnaires administered at each follow-up interval. Differences in mean costs and mean QALYs and net monetary benefits were estimated. Our primary analysis used net monetary benefit regressions to identify any interaction between the cost-effectiveness of sertraline and subgroups defined by baseline symptom severity (0-11; 12-19; 20+ on the Clinical Interview Schedule-Revised) and, separately, duration of symptoms (greater or less than 2 years duration). A secondary analysis estimated the cost-effectiveness of sertraline versus placebo, irrespective of duration or severity.
RESULTS


There was no evidence of an association between the baseline severity of depressive symptoms and the cost-effectiveness of sertraline. Compared to patients with low symptom severity, the expected net benefits in patients with moderate symptoms were £24 (95% CI - £280 to £328; p value 0.876) and the expected net benefits in patients with high symptom severity were £37 (95% CI - £221 to £296; p value 0.776). Patients who had a longer history of depressive symptoms at baseline had lower expected net benefits from sertraline than those with a shorter history; however, the difference was uncertain (- £27 [95% CI - £258 to £204]; p value 0.817). In the secondary analysis, patients treated with sertraline had higher expected net benefits (£122 [95% CI £18 to £226]; p value 0.101) than those in the placebo group. Sertraline had a high probability (> 95%) of being cost-effective if the health system was willing to pay at least £20,000 per QALY gained.
CONCLUSIONS


We found insufficient evidence of a prespecified threshold based on severity or symptom duration that GPs could use to target prescribing to a subgroup of patients where sertraline is most cost-effective. Sertraline is probably a cost-effective treatment for depressive symptoms in UK primary care.
TRIAL REGISTRATION


Controlled Trials ISRCTN Registry, ISRCTN84544741.",2020,There was no evidence of an association between the baseline severity of depressive symptoms and the cost-effectiveness of sertraline.,['Primary Care'],"['Sertraline', 'sertraline with placebo', 'NHS and Personal and Social Services (PSS', 'placebo', 'sertraline versus placebo', 'sertraline', 'PANDA', 'antidepressant sertraline']","['Quality of life data', 'Cost-Effectiveness', 'net benefits', 'longer history of depressive symptoms', 'duration or severity', 'mean costs and mean QALYs and net monetary benefits', 'cost-effectiveness']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037440', 'cui_str': 'Social Welfare'}, {'cui': 'C2931429', 'cui_str': 'Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal infections'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}]","[{'cui': 'C0034380'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",,0.267615,There was no evidence of an association between the baseline severity of depressive symptoms and the cost-effectiveness of sertraline.,"[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK. william.hollingworth@bristol.ac.uk.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Fawsitt', 'Affiliation': 'Health Information and Quality Authority, City Gate, Mahon, Cork, Ireland.'}, {'ForeName': 'Padraig', 'Initials': 'P', 'LastName': 'Dixon', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Duffy', 'Affiliation': 'Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, Kings' College London, Denmark Hill, London, SE5 8AF, UK.""}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Thom', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Nicky J', 'Initials': 'NJ', 'LastName': 'Welton', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Wiles', 'Affiliation': 'Bristol Medical School, University of Bristol, 5 Tyndall Avenue, Bristol, BS8 1UD, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, 6th Floor Maple House, 149 Tottenham Court Road, London, W1T 7NF, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PharmacoEconomics - open,['10.1007/s41669-019-00188-5']
536,31512395,Effect of short-term endurance training on venous compliance in the calf and forearm differs between continuous and interval exercise in humans.,"We examined whether the effect of short-term endurance exercise training on venous compliance in the calf and forearm differed between continuous and interval workloads. Young healthy volunteers (10 women and 16 men) were randomly assigned to continuous (C-TRA; n = 8) and interval (I-TRA; n = 9) exercise training groups, and a control group (n = 9). Subjects in the C-TRA group performed a continuous cycling exercise at 60% of heart rate reserve (HRR), and subjects in the I-TRA group performed a cycling exercise consisting of alternating 2-min intervals at 40% HRR and 80% HRR. Training programs were performed for 40 min/day, 3 days/week for 8 weeks. Before and after training, limb volume in the calf and forearm was measured with subjects in the supine position by venous occlusion plethysmography using a venous collecting cuff placed around the thigh and upper arm. Cuff pressure was held at 60 mmHg for 8 min and then decreased to 0 mmHg at a rate of 1 mmHg/s. Venous compliance was calculated as the numerical derivative of the cuff pressure-limb volume curve. Calf venous compliance was increased after I-TRA, but not C-TRA. Forearm venous compliance was unchanged after C-TRA or I-TRA. These results suggest that the adaptation of venous compliance in response to endurance training for 8 week may occur in interval but not continuous exercise bouts and may be specific to the exercising limb.",2019,Forearm venous compliance was unchanged after C-TRA or I-TRA.,"['Young healthy volunteers (10 women and 16 men', 'humans']","['continuous cycling exercise', 'cycling exercise consisting of alternating 2-min intervals at 40% HRR and 80% HRR', 'short-term endurance training', 'exercise training', 'short-term endurance exercise training']","['venous compliance', 'Venous compliance', 'Calf venous compliance', 'Forearm venous compliance', 'Cuff pressure']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",,0.0125761,Forearm venous compliance was unchanged after C-TRA or I-TRA.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Oue', 'Affiliation': 'Faculty of Food and Nutritional Sciences, Toyo University, Gunma, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Saito', 'Affiliation': 'Faculty of Food and Nutritional Sciences, Toyo University, Gunma, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Iimura', 'Affiliation': 'Graduate School of Food and Nutritional Sciences, Toyo University, Gunma, Japan.'}]",Physiological reports,['10.14814/phy2.14211']
537,31633865,The effect of acute exposure to morphine on breathing variability and cardiopulmonary coupling in men with obstructive sleep apnea: A randomized controlled trial.,"Opioid-related deaths from respiratory depression are increasing but there is only limited information on the effect of morphine on breathing during sleep. This study aimed to detect and quantify opioid-induced cardiorespiratory pattern changes during sleep in obstructive sleep apnea (OSA) patients using novel automated methods and correlate these with conventional polysomnography (PSG) measures. Under a randomized double-blind placebo-controlled crossover design, 60 male OSA patients attended two one-night visits to the sleep laboratory, at least a week apart. Either a 40-mg controlled-release oral morphine dose or placebo was administered. Breathing during sleep was measured by standard in-laboratory PSG. We analysed the inter-breath interval (IBI) from the PSG flow channel to quantify breathing irregularity. Cardiopulmonary coupling (CPC) was analysed using the PSG electrocardiogram (ECG) channel. Following the consumption of morphine, the 60 OSA patients had fewer breaths (p = .0006), a longer inter-breath interval (p < .0001) and more irregular breathing with increased IBI coefficient of variation (CV) (p = .0015) compared to the placebo night. A higher CPC sleep quality index was found with morphine use. The change of key IBI and CPC parameters was significantly correlated with the change of key PSG sleep-disordered breathing parameters. In conclusion, 40 mg controlled-release morphine resulted in a longer breathing cycle and increased breathing irregularity but generally more stable sleep in OSA patients. The significant links between the IBI and CPC techniques and a range of PSG sleep-disordered breathing parameters may suggest a practical value as surrogate overnight cardiorespiratory measurements, because both respiratory flow and ECG can be detected by small portable devices.",2020,"Following the consumption of morphine, the 60 OSA patients had fewer breaths (p = .0006), a longer inter-breath interval (p < .0001) and more irregular breathing with increased IBI coefficient of variation (CV) (p = .0015) compared to the placebo night.","['obstructive sleep apnea (OSA) patients', '60 male OSA patients attended two one-night visits to the sleep laboratory, at least a week apart', 'men with obstructive sleep apnea']","['morphine', 'Cardiopulmonary coupling (CPC', 'placebo', 'conventional polysomnography (PSG', 'morphine dose or placebo']","['change of key IBI and CPC parameters', 'longer breathing cycle and increased breathing irregularity', 'irregular breathing with increased IBI coefficient of variation (CV', 'Breathing during sleep', 'longer inter-breath interval', 'inter-breath interval (IBI', 'breathing variability and cardiopulmonary coupling', 'CPC sleep quality index']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0425492', 'cui_str': 'Irregular breathing (finding)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0587116', 'cui_str': 'During sleep (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.0561392,"Following the consumption of morphine, the 60 OSA patients had fewer breaths (p = .0006), a longer inter-breath interval (p < .0001) and more irregular breathing with increased IBI coefficient of variation (CV) (p = .0015) compared to the placebo night.","[{'ForeName': 'Justin G-A', 'Initials': 'JG', 'LastName': 'Wu', 'Affiliation': 'Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Rowsell', 'Affiliation': 'Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Keith K', 'Initials': 'KK', 'LastName': 'Wong', 'Affiliation': 'Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Yee', 'Affiliation': 'Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Chinh D', 'Initials': 'CD', 'LastName': 'Nguyen', 'Affiliation': 'Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Han', 'Affiliation': ""Department of Respiratory Medicine, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Hugi', 'Initials': 'H', 'LastName': 'Hilmisson', 'Affiliation': 'MyCardio-LLC, SleepImage®, Denver, CO, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Thomas', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Centre for Integrated Research and Understanding of Sleep (CIRUS), Woolcock Institute of Medical Research, Sydney Medical School, The University of Sydney, Sydney, NSW, Australia.'}]",Journal of sleep research,['10.1111/jsr.12930']
538,30180779,Clinical Outcomes from a Multi-Center Study of Human Neural Stem Cell Transplantation in Chronic Cervical Spinal Cord Injury.,"Human neural stem cell transplantation (HuCNS-SC ® ) is a promising central nervous system (CNS) tissue repair strategy in patients with stable neurological deficits from chronic spinal cord injury (SCI). These immature human neural cells have been demonstrated to survive when transplanted in vivo, extend neural processes, form synaptic contacts, and improve functional outcomes after experimental SCI. A phase II single blind, randomized proof-of-concept study of the safety and efficacy of HuCNS-SC transplantation into the cervical spinal cord was undertaken in patients with chronic C5-7 tetraplegia, 4-24 months post-injury. In Cohort I (n = 6) dose escalation from 15,000,000 to 40,000,000 cells was performed to determine the optimum dose. In Cohort II an additional six participants were transplanted at target dose (40,000,000) and compared with four untreated controls. Within the transplant group, there were nine American Spinal Injury Association Impairment Scale (AIS) B and three AIS A participants with a median age at transplant of 28 years with an average time to transplant post-injury of 1 year. Immunosuppression was continued for 6 months post-transplant, and immunosuppressive blood levels of tacrolimus were achieved and well tolerated. At 1 year post-transplantation, there was no evidence of additional spinal cord damage, new lesions, or syrinx formation on magnetic resonance (MR) imaging. In summary, the incremental dose escalation design established surgical safety, tolerability, and feasibility in Cohort I. Interim analysis of Cohorts I and II demonstrated a trend toward Upper Extremity Motor Score (UEMS) and Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) motor gains in the treated participants, but at a magnitude below the required clinical efficacy threshold set by the sponsor to support further development resulting in early study termination.",2019,"At 1 year post-transplantation, there was no evidence of additional spinal cord damage, new lesions, or syrinx formation on magnetic resonance (MR) imaging.","['Chronic Cervical Spinal Cord Injury', 'patients with chronic C5-7 tetraplegia, 4-24 months post-injury', 'A participants with a median age at transplant of 28 years with an average time to transplant post-injury of 1 year', 'patients with stable neurological deficits from chronic spinal cord injury (SCI']","['Human neural stem cell transplantation (HuCNS-SC ® ', 'Human Neural Stem Cell Transplantation', 'HuCNS-SC transplantation']","['tolerated', 'Upper Extremity Motor Score (UEMS) and Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP) motor gains', 'additional spinal cord damage, new lesions, or syrinx formation on magnetic resonance (MR) imaging', 'nine American Spinal Injury Association Impairment Scale (AIS) B and three AIS', 'surgical safety, tolerability, and feasibility', 'Immunosuppression']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0840414', 'cui_str': 'Cervical spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034372', 'cui_str': 'Tetraplegia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1113654', 'cui_str': 'Neural Stem Cells'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439823', 'cui_str': 'Sensibilities (qualifier value)'}, {'cui': 'C0037925', 'cui_str': 'Myelon'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0039147', 'cui_str': 'Syrinx (morphologic abnormality)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C4720884', 'cui_str': 'American Spinal Injury Association impairment scale (assessment scale)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}]",,0.0865345,"At 1 year post-transplantation, there was no evidence of additional spinal cord damage, new lesions, or syrinx formation on magnetic resonance (MR) imaging.","[{'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Levi', 'Affiliation': '1 Department of Neurological Surgery and the Miami Project to Cure Paralysis, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Anderson', 'Affiliation': '1 Department of Neurological Surgery and the Miami Project to Cure Paralysis, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'David O', 'Initials': 'DO', 'LastName': 'Okonkwo', 'Affiliation': '2 Department of Neurosurgery, University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Park', 'Affiliation': '3 Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Bryce', 'Affiliation': '4 Department of Rehabilitation Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Shekar N', 'Initials': 'SN', 'LastName': 'Kurpad', 'Affiliation': '5 Department of Neurosurgery, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Bizhan', 'Initials': 'B', 'LastName': 'Aarabi', 'Affiliation': '6 Department of Neurosurgery, University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hsieh', 'Affiliation': '7 StemCells Inc, Newark, California.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Gant', 'Affiliation': '1 Department of Neurological Surgery and the Miami Project to Cure Paralysis, University of Miami Miller School of Medicine, Miami, Florida.'}]",Journal of neurotrauma,['10.1089/neu.2018.5843']
539,32021696,A randomised feasibility trial comparing needle fasciotomy with limited fasciectomy treatment for Dupuytren's contractures.,"Purpose


The purpose of this study is to assess the feasibility of conducting a large, multicentre randomised controlled trial (RCT) comparing needle fasciotomy with limited fasciectomy for treatment of Dupuytren's contractures.
Design


The design of this study is a parallel, two-arm, multicentre, randomised feasibility trial with embedded QuinteT Recruitment Intervention.
Participants


Patients aged 18 years or over who were referred from primary to secondary care for treatment of a hand with Dupuytren's contractures of one or more fingers of more than 30° at the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints and well-defined cord(s). Patients were excluded if they had undergone previous Dupuytren's contracture surgery on the same hand.
Methods


Potential participants were screened for eligibility. Recruited participants randomised (1:1) to treatment with either needle fasciotomy or limited fasciectomy and followed-up for up to 6 months after treatment. Data on recruitment rates, completion of follow-up, and procedure costs were collected. Four patient reported outcome measures (PROMs) and objective outcome measures were collected before intervention and 6 weeks and 6 months afterwards.
Results


One hundred and fifty-three of 267 (57%) primary-care referrals for Dupuytren's contractures met the eligibility criteria for the study. Seventy-one of the 153 (46%) agreed to participate and were randomly allocated to treatment with needle fasciotomy or limited fasciectomy. Sixty-seven of these underwent their allocated treatment, two were crossovers from limited fasciectomy to needle fasciotomy, and two (both allocated limited fasciectomy) received no treatment. Fifty-nine participants (85%) completed 6-month follow-up PROMs. Participants felt the MYMOP, PEM and URAM PROMs allowed them to better describe how their treatment affected their hand function than the DASH PROM. The estimated costs of limited fasciectomy (in an operating theatre) and needle fasciotomy (in a clinic room) were £777 and £111 respectively.
Conclusion


A large RCT comparing treatment of Dupuytren's contractures by needle fasciotomy and limited fasciectomy is feasible. Data from this study will help determine the number of sites and duration of recruitment required to complete an adequately powered RCT and will assist the selection of PROMs in future studies on the treatment of Dupuytren's contractures. (Level 1 feasibility study).
Trial registration


Trial registered with ISRCTN (registration number: ISRCTN11164292), date assigned - 28/08/2015.",2020,Recruited participants randomised (1:1) to treatment with either needle fasciotomy or limited fasciectomy and followed-up for up to 6 months after treatment.,"['Fifty-nine participants (85%) completed 6-month follow-up PROMs', 'One hundred and fifty-three of 267 (57', ""Participants\n\n\nPatients aged 18\u2009years or over who were referred from primary to secondary care for treatment of a hand with Dupuytren's contractures of one or more fingers of more than 30° at the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints and well-defined cord(s"", 'Seventy-one of the 153 (46%) agreed to participate', ""Dupuytren's contractures"", ""Patients were excluded if they had undergone previous Dupuytren's contracture surgery on the same hand""]","['needle fasciotomy or limited fasciectomy', 'embedded QuinteT Recruitment Intervention', 'needle fasciotomy with limited fasciectomy', 'needle fasciotomy with limited fasciectomy treatment']","['recruitment rates, completion of follow-up, and procedure costs']","[{'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0013312', 'cui_str': 'Dupuytren Contracture'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0442825', 'cui_str': 'Well defined (qualifier value)'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0185188', 'cui_str': 'Fasciectomy'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.128635,Recruited participants randomised (1:1) to treatment with either needle fasciotomy or limited fasciectomy and followed-up for up to 6 months after treatment.,"[{'ForeName': 'T R C', 'Initials': 'TRC', 'LastName': 'Davis', 'Affiliation': ""1Nottingham University Hospitals NHS Trust, Queen's Medical Centre, Derby Road, Nottingham, NG7 2UH UK.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': '2Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD UK.'}, {'ForeName': 'E F', 'Initials': 'EF', 'LastName': 'Harrison', 'Affiliation': '2Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': '3Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Karantana', 'Affiliation': '4Centre for Evidence Based Hand Surgery, Academic Orthopaedics Trauma and Sports Medicine, School of Medicine, University of Nottingham, Nottingham, NG7 2UH UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mills', 'Affiliation': '3Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hepburn', 'Affiliation': '2Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Sprange', 'Affiliation': '2Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Duley', 'Affiliation': '2Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD UK.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Blazeby', 'Affiliation': '3Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS UK.'}, {'ForeName': 'C G', 'Initials': 'CG', 'LastName': 'Bainbridge', 'Affiliation': '5Derby Teaching Hospitals NHS Foundation Trust, Uttoxeter Road, Derby, DE22 3NE UK.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Murali', 'Affiliation': '6Wrightington, Wigan and Leigh NHS Foundation Trust, Hall Lane, Appley Bridge, Wigan, Lancashire WN6 9EP UK.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Montgomery', 'Affiliation': '2Nottingham Clinical Trials Unit, University of Nottingham, Building 42, University Park, Nottingham, NG7 2RD UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pilot and feasibility studies,['10.1186/s40814-019-0546-y']
540,32157623,Acceptability of a Computer-Tailored Safer Sex Intervention for Heterosexually Active African Americans Attending an STI Clinic.,"Since African Americans are disproportionately affected by HIV/AIDS, interventions that increase correct and consistent condom use are urgently needed. We report baseline acceptability data from a randomized controlled trial (RCT) testing the Tailored Information Program for Safer Sex, a computer-tailored intervention designed to increase correct and consistent condom use among low income, heterosexually active African Americans attending an urban sexually transmitted infection (STI) clinic. We enrolled 274 participants at baseline in an RCT-147 in the intervention group. The intervention had high acceptability, with a mean acceptability of 4.35 on a 5-point scale. We conducted a multiple regression analysis examining demographic, structural, and sexual risk characteristics that revealed only sex to be significantly (p < .01) associated with intervention acceptability. While women were more likely than men to find the intervention acceptable, overall the results indicated broad acceptability of this intervention to the target audience. eHealth interventions are a viable option for HIV prevention among African Americans visiting a publicly-funded STI clinic. We discuss implications of these results for the future application of such programs.",2020,"While women were more likely than men to find the intervention acceptable, overall the results indicated broad acceptability of this intervention to the target audience.","['African Americans visiting a publicly-funded STI clinic', '274 participants at baseline in an RCT-147 in the intervention group', 'Since African Americans', 'African Americans attending an urban sexually transmitted infection (STI) clinic', 'Heterosexually Active African Americans Attending an STI Clinic']",['Computer-Tailored Safer Sex Intervention'],[],"[{'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}]",[],274.0,0.0311334,"While women were more likely than men to find the intervention acceptable, overall the results indicated broad acceptability of this intervention to the target audience.","[{'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Noar', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina at Chapel Hill, 382 Carroll Hall, Campus Box 3365, Chapel Hill, NC, 27599-3365, USA. noar@unc.edu.'}, {'ForeName': 'Jessica Fitts', 'Initials': 'JF', 'LastName': 'Willoughby', 'Affiliation': 'The Edward R. Murrow College of Communication, Washington State University, Pullman, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Crosby', 'Affiliation': 'College of Public Health, University of Kentucky, Lexington, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Webb', 'Affiliation': 'Department of Communication, University of South Carolina Aiken, Aiken, USA.'}, {'ForeName': 'Stephanie K', 'Initials': 'SK', 'LastName': 'Van Stee', 'Affiliation': 'Department of Communication and Media, University of Missouri-St. Louis, St. Louis, USA.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Feist-Price', 'Affiliation': 'College of Education, University of Kentucky, Lexington, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Davis', 'Affiliation': ', Louisville, KY, USA.'}]",The journal of primary prevention,['10.1007/s10935-020-00585-1']
541,30859755,Home-Based Exercise in Patients Awaiting Liver Transplantation: A Feasibility Study.,"Frailty is associated with increased mortality both before and after liver transplantation (LT). There are no standardized exercise programs, in particular home-based exercise programs (HBEPs), for patients awaiting LT. The aim was to investigate the feasibility of such a program in patients awaiting LT. Patients were randomly selected from the Birmingham LT waiting list and provided with a 12-week HBEP, including average daily step (ADS) targets and twice-weekly resistance exercises. Feasibility was based on patient eligibility (≥66% of waiting list), target recruitment (≥90% of n = 20), safety (no related serious adverse events), and adherence (≥66% adherence to 6-week HBEP). Measures of aerobic (incremental shuttle walk test [ISWT], ADS), functional capacity (short physical performance battery test [SPPBT]), and health-related quality of life (EuroQol 5-Dimension 5-Level (EQ-5D-5L) and hospital anxiety and depression score [HADS]) were taken at baseline and at 6 and 12 weeks. 18 patients (50% male; median age, 55 years) were recruited. All domains of the study feasibility criteria were met. ISWT improved after 6 weeks (50 m; P ≤ 0.01) and 12 weeks (210 m; P ≤ 0.01), despite withdrawal of the telephone health calls. Similarly, improvements were seen in ADS (2700/day; P ≤ 0.01) and the SPPBT (2.5; P = 0.02) after 12 weeks. There was no difference in HADS (median difference [MD] -3; P = 0.69), but EQ-5D-5L after 12 weeks (17.5%; P = 0.04). In conclusion, a 12-week HBEP, incorporating both easy-to-apply resistance and aerobic exercises, is safe and feasible in patients awaiting LT. Measures of aerobic and functional capacity demonstrate trends toward improvement that warrant further investigation in a randomized controlled trial.",2019,"There was no difference in HADS (median difference [MD] -3; P = 0.69), but EQ-5D-5L after 12 weeks (17.5%; P = 0.04).","['patients awaiting LT', '18 patients (50% male; median age, 55 years) were recruited', 'Patients Awaiting Liver Transplantation']","['Birmingham LT waiting list and provided with a 12-week HBEP, including average daily step (ADS) targets and twice-weekly resistance exercises', 'Home-Based Exercise']","['ISWT', 'Measures of aerobic (incremental shuttle walk test [ISWT], ADS), functional capacity (short physical performance battery test [SPPBT]), and health-related quality of life (EuroQol 5-Dimension 5-Level (EQ-5D-5L) and hospital anxiety and depression score [HADS', 'HADS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}]","[{'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}]",,0.0341438,"There was no difference in HADS (median difference [MD] -3; P = 0.69), but EQ-5D-5L after 12 weeks (17.5%; P = 0.04).","[{'ForeName': 'Felicity Rhian', 'Initials': 'FR', 'LastName': 'Williams', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Vallance', 'Affiliation': 'Department of Physiotherapy, Queen Elizabeth University Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Faulkner', 'Affiliation': 'Department of Anaesthesia, Queen Elizabeth University Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Towey', 'Affiliation': 'Department of Dietetics, Queen Elizabeth University Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Durman', 'Affiliation': 'Advanced Personal Trainer, Virgin Active Solihull, Solihull, United Kingdom.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Kyte', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'Elsharkawy', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Thamara', 'Initials': 'T', 'LastName': 'Perera', 'Affiliation': 'Liver Transplant Unit, Queen Elizabeth University Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Holt', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ferguson', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Lord', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Matthew James', 'Initials': 'MJ', 'LastName': 'Armstrong', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, United Kingdom.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25442']
542,31874736,The cardiac output optimisation following liver transplant (COLT) trial: a feasibility randomised controlled trial.,"BACKGROUND


Perioperative goal directed fluid therapy (GDFT) has been shown to reduce postoperative complications following major surgery; this intervention has not been formally evaluated in the setting of liver transplantation.
METHODS


We conducted a prospective trial of GDFT following liver transplantation randomising patients with liver cirrhosis to either 12 h of GDFT using non-invasive cardiac output monitoring or standard care (SC). The primary outcome was feasibility. Secondary outcomes included survival, postoperative complications (Clavien-Dindo), quality of life (by EQ-5D-5L) and resource use. Trial specific follow up occurred at 90 and 180 days after surgery.
RESULTS


The study was feasible. Of 224 eligible patients, 122 were approached, 114 consented to participate and 60 were enrolled into the trial. The mean (SD) volume of IV crystalloid administered to the GDFT group during the 12-h study period was 3968 (2073) ml for the GDFT group and 2510 (1026) ml for the SC group. As regards secondary outcomes there was no difference in survival or overall complication rates. There was no significant difference in quality of life scores and resource use between the groups.
CONCLUSION


A randomised study of GDFT following liver transplantation is feasible. A post-trial stakeholder meeting supported proceeding with a full multi-centre trial.",2020,"There was no significant difference in quality of life scores and resource use between the groups.
","['liver transplantation randomising patients with liver cirrhosis to either 12\xa0h of GDFT using non-invasive cardiac output monitoring or standard care (SC', '1026', '224 eligible patients, 122 were approached, 114 consented to participate and 60 were enrolled into the trial', 'group and 2510']","['fluid therapy (GDFT', 'GDFT']","['quality of life scores and resource use', 'survival or overall complication rates', 'survival, postoperative complications (Clavien-Dindo), quality of life (by EQ-5D-5L) and resource use', 'mean (SD) volume']","[{'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C3875571', 'cui_str': 'Non-invasive cardiac output monitoring'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}]","[{'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",122.0,0.369461,"There was no significant difference in quality of life scores and resource use between the groups.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': 'University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK; Royal Free Perioperative Research Group, Department of Anaesthesia, Royal Free Hospital, 3rd Floor, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Koti', 'Affiliation': 'University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK; Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Kurinchi', 'Initials': 'K', 'LastName': 'Gurusamy', 'Affiliation': 'University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Longworth', 'Affiliation': 'PHMR Limited, Berkeley Works, Berkley Grove, London, NW1 8XY, UK.'}, {'ForeName': 'Jeshika', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'PHMR Limited, Berkeley Works, Berkley Grove, London, NW1 8XY, UK; Health Economics Research Group, Brunel University, Uxbridge, UB8 3PH, UK.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Froghi', 'Affiliation': 'University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK; Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Fiammetta', 'Initials': 'F', 'LastName': 'Soggiu', 'Affiliation': 'University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK; Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Mallett', 'Affiliation': 'Royal Free Perioperative Research Group, Department of Anaesthesia, Royal Free Hospital, 3rd Floor, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Schofield', 'Affiliation': 'Royal Free Perioperative Research Group, Department of Anaesthesia, Royal Free Hospital, 3rd Floor, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Selves', 'Affiliation': 'Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Thorburn', 'Affiliation': 'Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Eastgate', 'Affiliation': 'Royal Free Perioperative Research Group, Department of Anaesthesia, Royal Free Hospital, 3rd Floor, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Helder', 'Initials': 'H', 'LastName': 'Filipe', 'Affiliation': 'Royal Free Perioperative Research Group, Department of Anaesthesia, Royal Free Hospital, 3rd Floor, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McNeil', 'Affiliation': 'Royal Free Perioperative Research Group, Department of Anaesthesia, Royal Free Hospital, 3rd Floor, Pond Street, London, NW3 2QG, UK.'}, {'ForeName': 'Zacharias', 'Initials': 'Z', 'LastName': 'Anastasiou', 'Affiliation': 'Department of Statistical Science, University College London, Gower St, London, WC1E 6BT, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Davidson', 'Affiliation': 'University College London, Division of Surgery and Interventional Science, Royal Free Hospital, Pond Street, London, NW3 2QG, UK; Hepato-Pancreato-Biliary and Liver Transplant Unit, Royal Free Hospital, Pond Street, London, NW3 2QG, UK. Electronic address: b.davidson@ucl.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",HPB : the official journal of the International Hepato Pancreato Biliary Association,['10.1016/j.hpb.2019.11.011']
543,32150750,"Immunogenicity, Safety, and Efficacy of a Standalone Universal Influenza Vaccine, FLU-v, in Healthy Adults: A Randomized Clinical Trial.","Background


FLU-v is a broad-spectrum influenza vaccine that induces antibodies and cell-mediated immunity.
Objective


To compare the safety, immunogenicity, and exploratory efficacy of different formulations and dosing regimens of FLU-v versus placebo.
Design


Randomized, double-blind, placebo-controlled, single-center phase 2b clinical trial. (ClinicalTrials.gov: NCT02962908; EudraCT: 2015-001932-38).
Setting


The Netherlands.
Participants


175 healthy adults aged 18 to 60 years.
Intervention


0.5-mL subcutaneous injection of 500 µg of adjuvanted (1 dose) or nonadjuvanted (2 doses) FLU-v (A-FLU-v or NA-FLU-v) or adjuvanted or nonadjuvanted placebo (A-placebo or NA-placebo) (2:2:1:1 ratio).
Measurements


Vaccine-specific cellular responses at days 0, 42, and 180 were assessed via flow cytometry and enzyme-linked immunosorbent assay. Solicited information on adverse events (AEs) was collected for 21 days after vaccination. Unsolicited information on AEs was collected throughout the study.
Results


The AEs with the highest incidence were mild to moderate injection site reactions. The difference between A-FLU-v and A-placebo in the median fold increase in secreted interferon-γ (IFN-γ) was 38.2-fold (95% CI, 4.7- to 69.7-fold; P = 0.001) at day 42 and 25.0-fold (CI, 5.7- to 50.9-fold; P < 0.001) at day 180. The differences between A-FLU-v and A-placebo in median fold increase at day 42 were 4.5-fold (CI, 2.3- to 9.8-fold; P < 0.001) for IFN-γ-producing CD4+ T cells, 4.9-fold (CI, 1.3- to 40.0-fold; P < 0.001) for tumor necrosis factor-α (TNF-α), 7.0-fold (CI, 3.5- to 18.0-fold; P < 0.001) for interleukin-2 (IL-2), and 1.7-fold (CI, 0.1- to 4.0-fold; P = 0.004) for CD107a. At day 180, differences were 2.1-fold (CI, 0.0- to 6.0-fold; P = 0.030) for IFN-γ and 5.7-fold (CI, 2.0- to 15.0-fold; P < 0.001) for IL-2, with no difference for TNF-α or CD107a. No differences were seen between NA-FLU-v and NA-placebo.
Limitation


The study was not powered to evaluate vaccine efficacy against influenza infection.
Conclusion


Adjuvanted FLU-v is immunogenic and merits phase 3 development to explore efficacy.
Primary Funding Source


SEEK and the European Commission Directorate-General for Research and Innovation, European Member States within the UNISEC (Universal Influenza Vaccines Secured) project.",2020,"The differences between A-FLU-v and A-placebo in median fold increase at day 42 were 4.5-fold (CI, 2.3- to 9.8-fold; P < 0.001) for IFN-γ-producing CD4+ T cells, 4.9-fold (CI, 1.3- to 40.0-fold; P < 0.001) for tumor necrosis factor-α (TNF-α),","['Participants\n\n\n175 healthy adults aged 18 to 60 years', 'Healthy Adults']","['Standalone Universal Influenza Vaccine, FLU', 'Intervention\n\n\n0.5-mL', 'placebo', 'FLU-v versus placebo', 'subcutaneous injection of 500 µg of adjuvanted (1 dose) or nonadjuvanted (2 doses) FLU-v (A-FLU-v or NA-FLU-v) or adjuvanted or nonadjuvanted placebo (A-placebo or NA-placebo']","['safety, immunogenicity, and exploratory efficacy', 'Immunogenicity, Safety, and Efficacy', 'adverse events (AEs', 'secreted interferon-γ (IFN-γ']","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4505399', 'cui_str': 'Universal Influenza Vaccines'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}]",175.0,0.648406,"The differences between A-FLU-v and A-placebo in median fold increase at day 42 were 4.5-fold (CI, 2.3- to 9.8-fold; P < 0.001) for IFN-γ-producing CD4+ T cells, 4.9-fold (CI, 1.3- to 40.0-fold; P < 0.001) for tumor necrosis factor-α (TNF-α),","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Pleguezuelos', 'Affiliation': 'SEEK, London, United Kingdom (O.P., A.F.P., E.J., G.S.).'}, {'ForeName': 'Joep', 'Initials': 'J', 'LastName': 'Dille', 'Affiliation': 'Isala Hospital, Zwolle, the Netherlands (J.D., S.D., P.G.).'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'de Groen', 'Affiliation': 'Isala Hospital, Zwolle, the Netherlands (J.D., S.D., P.G.).'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Oftung', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway (F.O., L.M.N., O.H.).'}, {'ForeName': 'Hubert G M', 'Initials': 'HGM', 'LastName': 'Niesters', 'Affiliation': 'University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands (H.G.N.).'}, {'ForeName': 'Md Atiqul', 'Initials': 'MA', 'LastName': 'Islam', 'Affiliation': 'Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands, and Shahjalal University of Science and Technology, Sylhet, Bangladesh (M.A.I.).'}, {'ForeName': 'Lisbeth Meyer', 'Initials': 'LM', 'LastName': 'Næss', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway (F.O., L.M.N., O.H.).'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Hungnes', 'Affiliation': 'Norwegian Institute of Public Health, Oslo, Norway (F.O., L.M.N., O.H.).'}, {'ForeName': 'Nuhoda', 'Initials': 'N', 'LastName': 'Aldarij', 'Affiliation': 'Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands (N.A., D.L.I., H.W.F., E.H.).'}, {'ForeName': 'Demi L', 'Initials': 'DL', 'LastName': 'Idema', 'Affiliation': 'Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands (N.A., D.L.I., H.W.F., E.H.).'}, {'ForeName': 'Ana Fernandez', 'Initials': 'AF', 'LastName': 'Perez', 'Affiliation': 'SEEK, London, United Kingdom (O.P., A.F.P., E.J., G.S.).'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'James', 'Affiliation': 'SEEK, London, United Kingdom (O.P., A.F.P., E.J., G.S.).'}, {'ForeName': 'Henderik W', 'Initials': 'HW', 'LastName': 'Frijlink', 'Affiliation': 'Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands (N.A., D.L.I., H.W.F., E.H.).'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Stoloff', 'Affiliation': 'SEEK, London, United Kingdom (O.P., A.F.P., E.J., G.S.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Groeneveld', 'Affiliation': 'Isala Hospital, Zwolle, the Netherlands (J.D., S.D., P.G.).'}, {'ForeName': 'Eelko', 'Initials': 'E', 'LastName': 'Hak', 'Affiliation': 'Groningen Research Institute of Pharmacy, University of Groningen, Groningen, the Netherlands (N.A., D.L.I., H.W.F., E.H.).'}]",Annals of internal medicine,['10.7326/M19-0735']
544,32147306,The impact of Community intervention on the time from Symptom onset to first medical contact with acute coronary syndrome.,"OBJECTIVE


Patient delay in the recognition of and response to the symptoms of acute coronary syndrome (ACS) is a worldwide problem. A community education program about chest pain was implemented in China, and was aimed at providing better community intervention. In this study, the impact of this program on the time of symptom onset to the first medical contact (SO-to-FMC) in ACS patients was investigated, as was the incidence of major adverse cardiac and cerebrovascular events (MACCE) in these patients.
METHODS


A total of 10 local communities were included in this study. A 9-month intensive community education program about chest pain was conducted in these communities. The data on the demographics, mode of transportation, procedures, clinical outcomes, and discharge diagnoses of all ACS patients in these communities were collected.
RESULTS


The study communities had a combined population of 361,609, and all community population sizes ranged from 12,823 to 66,127. The average SO-to-FMC time of the control period was 510 min, whereas, following community intervention, the average SO-to-FMC time was 256 min (P <  0.001). Furthermore, comparative analyses revealed that, following discharge from the hospital, the 1.5-year MACCE-free survival rate was higher in the community intervention group than in the control group (95.0 % vs. 90.5 %, P =  0.025), and the 1.5-year mortality rate was lower in the community intervention group than in the control group (3.3 % vs. 6.3 %, P =  0.03).
CONCLUSIONS AND PRACTICAL IMPLICATIONS


The Hangzhou Chest Pain Science Education Project(HCPSEP) was found to reduce the SO-to-FMC time and improve the outcome of ACS patients. This indicates that a scientific, educational program on chest pain can be effective in improving the knowledge and alertness of the local residents about chest pain. This type of program may be recognized and carried out in other regions.",2020,"This indicates that a scientific, educational program on chest pain can be effective in improving the knowledge and alertness of the local residents about chest pain.","['A total of 10 local communities', 'acute coronary syndrome', 'study communities had a combined population of 361,609, and all community population sizes ranged from 12,823 to 66,127']","['intensive community education program', 'Community intervention']","['1.5-year MACCE-free survival rate', 'average SO-to-FMC time', 'incidence of major adverse cardiac and cerebrovascular events (MACCE', '1.5-year mortality rate']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0032683', 'cui_str': 'Population Size'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0009470', 'cui_str': 'Community Health Education'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",,0.0194084,"This indicates that a scientific, educational program on chest pain can be effective in improving the knowledge and alertness of the local residents about chest pain.","[{'ForeName': 'Ming-Wei', 'Initials': 'MW', 'LastName': 'Wang', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Yong-Ran', 'Initials': 'YR', 'LastName': 'Cheng', 'Affiliation': 'Zhejiang Academy of Medical Sciences, Hangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Zhi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Wen-Tao', 'Initials': 'WT', 'LastName': 'Gan', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Aliaweisali', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Min-Juan', 'Initials': 'MJ', 'LastName': 'Wu', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Kai-Han', 'Initials': 'KH', 'LastName': 'Ren', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Yu-Lin', 'Initials': 'YL', 'LastName': 'Chen', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China.'}, {'ForeName': 'Jun-Zhe', 'Initials': 'JZ', 'LastName': 'Bao', 'Affiliation': 'Sun Yat-Sen University, Guangzhou, China.'}, {'ForeName': 'Zhan-Hui', 'Initials': 'ZH', 'LastName': 'Feng', 'Affiliation': 'Affiliated Hospital of Guizhou Medical University, Department of Neurology, Guiyang, China. Electronic address: h9450203@126.com.'}, {'ForeName': 'Xing-Wei', 'Initials': 'XW', 'LastName': 'Zhang', 'Affiliation': 'Affiliated Hospital of Hangzhou Normal University, Department of Cardioogy, Hangzhou, China. Electronic address: hsdzxw@126.com.'}]",Patient education and counseling,['10.1016/j.pec.2020.02.041']
545,31848678,"Comparison of Common Surgical Procedures in Non-complicated Pilonidal Sinus Disease, a 7-Year Follow-Up Trial.","BACKGROUND


Pilonidal disease is a common problem in primary health care which may require immediate surgical referral. Although various management options have been proposed, so far there is no gold standard treatment. The aim of the present study was to determine which of the following techniques was superior as regards postoperative complications and recurrence, midline unshifted adipofascial turn-over flap, midline shifted adipofascial turn-over flap or Karydakis flap.
METHODS


A randomized clinical trial was conducted in the Department of General Surgery. Patients with non-complicated pilonidal sinus were enrolled in the study from April 2009 to January 2012. All patients were randomized the day of surgery at the coordinating center by means of a computer program. Patients were randomized to receive midline unshifted adipofascial turn-over flap, midline shifted adipofascial turn-over flap or Karydakis flap. All procedures were performed under local anesthesia and patients were discharged 6 h after surgery. Demographic characteristics, skin color, body hair type, family history, preoperative complaints and duration of symptoms, cyst size, intraoperative iatrogenic cyst rupture, the presence of a tuft of hairs in the cyst, surgical techniques, duration of drainage, length of hospital stay, postoperative complications and recurrence were evaluated.
RESULTS


One hundred and ninety-two patients with non-complicated pilonidal sinus were enrolled. Seventy-two patients were randomized to midline unshifted adipofascial turn-over flap, 67 patients to midline shifted adipofascial turn-over flap and 53 patients to Karydakis flap. The mean age was 25.66 ± 7.67 years. At 76-month follow-up, the overall complications and recurrence rates were not significantly different between groups (p > 0.05).
CONCLUSION


In cases of non-complicated pilonidal sinus, we recommend surgical management using local anesthesia, outpatient surgery and the surgical approach with which the surgeon is most familiar.",2020,"At 76-month follow-up, the overall complications and recurrence rates were not significantly different between groups (p > 0.05).
","['One hundred and ninety-two patients with non-complicated pilonidal sinus were enrolled', 'The mean age was 25.66\u2009±\u20097.67\xa0years', 'Patients with non-complicated pilonidal sinus were enrolled in the study from April 2009 to January 2012', 'Department of General Surgery']","['midline unshifted adipofascial turn-over flap, midline shifted adipofascial turn-over flap or Karydakis flap', 'midline unshifted adipofascial turn-over flap, 67 patients to midline shifted adipofascial turn-over flap and 53 patients to Karydakis flap']","['overall complications and recurrence rates', 'Demographic characteristics, skin color, body hair type, family history, preoperative complaints and duration of symptoms, cyst size, intraoperative iatrogenic cyst rupture, the presence of a tuft of hairs in the cyst, surgical techniques, duration of drainage, length of hospital stay, postoperative complications and recurrence']","[{'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0037290', 'cui_str': 'Skin Tone'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts (observable entity)'}, {'cui': 'C0010709', 'cui_str': 'Cyst'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0439669', 'cui_str': 'Iatrogenic (qualifier value)'}, {'cui': 'C0333140', 'cui_str': 'Ruptured cyst (morphologic abnormality)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",192.0,0.0452193,"At 76-month follow-up, the overall complications and recurrence rates were not significantly different between groups (p > 0.05).
","[{'ForeName': 'Mujgan', 'Initials': 'M', 'LastName': 'Caliskan', 'Affiliation': 'Department of General Surgery, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Koray', 'Initials': 'K', 'LastName': 'Kosmaz', 'Affiliation': 'Department of General Surgery, Umraniye Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ismail Ege', 'Initials': 'IE', 'LastName': 'Subasi', 'Affiliation': 'Department of General Surgery, Umraniye Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Aylin', 'Initials': 'A', 'LastName': 'Acar', 'Affiliation': 'Department of General Surgery, Umraniye Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Evren', 'Affiliation': 'Department of Urology, Dr. Sadi Konuk Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Gurhan', 'Initials': 'G', 'LastName': 'Bas', 'Affiliation': 'Department of General Surgery, Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'Ali Timucin', 'Initials': 'AT', 'LastName': 'Atayoglu', 'Affiliation': 'Department of Family Medicine, Istanbul Medipol University, Istanbul, Turkey. atatayoglu@medipol.edu.tr.'}]",World journal of surgery,['10.1007/s00268-019-05331-1']
546,31390590,Screening and Stepped Care Targeting Psychological Distress in Patients With Metastatic Colorectal Cancer: The TES Cluster Randomized Trial.,"BACKGROUND


This study evaluated the effectiveness of a screening and stepped care program (the TES program) in reducing psychological distress compared with care as usual (CAU) in patients with metastatic colorectal cancer starting with first-line systemic palliative treatment.
PATIENTS AND METHODS


In this cluster randomized trial, 16 hospitals were assigned to the TES program or CAU. Patients in the TES arm were screened for psychological distress with the Hospital Anxiety and Depression Scale and the Distress Thermometer/Problem List (at baseline and 10 and 18 weeks). Stepped care was offered to patients with distress or expressed needs, and it consisted of watchful waiting, guided self-help, face-to-face problem-solving therapy, or referral to specialized mental healthcare. The primary outcome was change in psychological distress over time, and secondary outcomes were quality of life, satisfaction with care, and recognition and referral of distressed patients by clinicians. Linear mixed models and effect sizes were used to evaluate differences.
RESULTS


A total of 349 patients were randomized; 184 received the TES program and 165 received CAU. In the TES arm, 60.3% of the patients screened positive for psychological distress, 26.1% of which entered the stepped care program (14.7% used only watchful waiting and 11.4% used at least one of the other treatment steps). The observed low use of the TES program led us to pursue a futility analysis, which showed a small conditional power and therefore resulted in halted recruitment for this study. No difference was seen in change in psychological distress over time between the 2 groups (effect size, -0.16; 95% CI, -0.35 to 0.03; P>.05). The TES group reported higher satisfaction with the received treatment and better cognitive quality of life (all P<.05).
CONCLUSIONS


As a result of the low use of stepped care, a combined screening and treatment program targeting psychological distress in patients with metastatic colorectal cancer did not improve psychological distress. Our results suggest that enhanced evaluation of psychosocial concerns may improve aspects of patient well-being.",2019,"The TES group reported higher satisfaction with the received treatment and better cognitive quality of life (all P<.05).
","['Patients', 'With Metastatic Colorectal Cancer', '349 patients were randomized; 184 received the', 'patients with metastatic colorectal cancer starting with first-line systemic palliative treatment', '16 hospitals', 'patients with metastatic colorectal cancer']","['TES program and 165 received CAU', 'TES', 'care as usual (CAU', 'screening and stepped care program (the TES program', 'TES program or CAU', 'Screening and Stepped Care', 'watchful waiting, guided self-help, face-to-face problem-solving therapy, or referral to specialized mental healthcare']","['psychological distress with the Hospital Anxiety and Depression Scale and the Distress Thermometer/Problem List', 'psychological distress', 'psychological distress over time, and secondary outcomes were quality of life, satisfaction with care, and recognition and referral of distressed patients by clinicians', 'cognitive quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0030231', 'cui_str': 'Palliative Supportive Care'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0700325', 'cui_str': 'Waitings, Watchful'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0039818', 'cui_str': 'Thermometers'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",349.0,0.121005,"The TES group reported higher satisfaction with the received treatment and better cognitive quality of life (all P<.05).
","[{'ForeName': 'Claudia S E W', 'Initials': 'CSEW', 'LastName': 'Schuurhuizen', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam.'}, {'ForeName': 'Annemarie M J', 'Initials': 'AMJ', 'LastName': 'Braamse', 'Affiliation': 'Department of Medical Psychology, Cancer Center Amsterdam, Amsterdam Public Health Institute, Academic Medical Center, Amsterdam.'}, {'ForeName': 'Aartjan T F', 'Initials': 'ATF', 'LastName': 'Beekman', 'Affiliation': 'Department of Psychiatry and Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical Psychology, VU University, Amsterdam.'}, {'ForeName': 'Mecheline H M', 'Initials': 'MHM', 'LastName': 'van der Linden', 'Affiliation': 'Department of Medical Psychology, and.'}, {'ForeName': 'Adriaan W', 'Initials': 'AW', 'LastName': 'Hoogendoorn', 'Affiliation': 'Department of Psychiatry and Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Berkhof', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, VU University Medical Center, Amsterdam.'}, {'ForeName': 'Dirkje W', 'Initials': 'DW', 'LastName': 'Sommeijer', 'Affiliation': 'Department of Medical Oncology, Flevoziekenhuis, Almere.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Lustig', 'Affiliation': 'Department of Medical Oncology, Flevoziekenhuis, Almere.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Vrijaldenhoven', 'Affiliation': 'Department of Medical Oncology, Noordwest Ziekenhuisgroep, Alkmaar.'}, {'ForeName': 'Haiko J', 'Initials': 'HJ', 'LastName': 'Bloemendal', 'Affiliation': 'Department of Medical Oncology, Meander Medical Center, Amersfoort.'}, {'ForeName': 'Cees J', 'Initials': 'CJ', 'LastName': 'van Groeningen', 'Affiliation': 'Department of Medical Oncology, Hospital Amstelland, Amstelveen.'}, {'ForeName': 'Annette A', 'Initials': 'AA', 'LastName': 'van Zweeden', 'Affiliation': 'Department of Medical Oncology, Hospital Amstelland, Amstelveen.'}, {'ForeName': 'Maurice J D L', 'Initials': 'MJDL', 'LastName': 'van der Vorst', 'Affiliation': 'Department of Medical Oncology, Rijnstate Hospital, Arnhem.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Rietbroek', 'Affiliation': 'Department of Medical Oncology, Red Cross Hospital, Beverwijk.'}, {'ForeName': 'Cathrien S', 'Initials': 'CS', 'LastName': 'Tromp-van Driel', 'Affiliation': 'Department of Medical Oncology, Noordwest Ziekenhuisgroep, Den Helder.'}, {'ForeName': 'Machteld N W', 'Initials': 'MNW', 'LastName': 'Wymenga', 'Affiliation': 'Department of Medical Oncology, Medisch Spectrum Twente, Enschede.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'van der Linden', 'Affiliation': 'Department of Medical Oncology, Spaarne Gasthuis, Haarlem.'}, {'ForeName': 'Aart', 'Initials': 'A', 'LastName': 'Beeker', 'Affiliation': 'Department of Medical Oncology, Spaarne Gasthuis, Hoofddorp.'}, {'ForeName': 'Marco B', 'Initials': 'MB', 'LastName': 'Polee', 'Affiliation': 'Department of Medical Oncology, Medical Center Leeuwarden, Leeuwarden.'}, {'ForeName': 'Erdogan', 'Initials': 'E', 'LastName': 'Batman', 'Affiliation': 'Department of Medical Oncology, Alrijne Hospital, Leiden.'}, {'ForeName': 'Maartje', 'Initials': 'M', 'LastName': 'Los', 'Affiliation': 'Department of Medical Oncology, St. Antonius Hospital, Nieuwegein.'}, {'ForeName': 'Aart', 'Initials': 'A', 'LastName': 'van Bochove', 'Affiliation': 'Department of Medical Oncology, Zaans Medical Center, Zaandam; and.'}, {'ForeName': 'Jan A C', 'Initials': 'JAC', 'LastName': 'Brakenhoff', 'Affiliation': 'Department of Medical Oncology, Waterland Hospital, Purmerend, the Netherlands.'}, {'ForeName': 'Inge R H M', 'Initials': 'IRHM', 'LastName': 'Konings', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam.'}, {'ForeName': 'Henk M W', 'Initials': 'HMW', 'LastName': 'Verheul', 'Affiliation': 'Department of Medical Oncology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Dekker', 'Affiliation': 'Department of Psychiatry and Amsterdam Public Health Research Institute, VU University Medical Center, Amsterdam.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2019.7285']
547,31735645,"Transcranial direct current stimulation associated with physical-therapy in acute stroke patients - A randomized, triple blind, sham-controlled study.","BACKGROUND


Transcranial Direct Current Stimulation has been increasing in popularity in the last few years. Despite vast amounts of articles on the use of tDCS on stroke patients, very little has been done during the acute phase.
OBJECTIVES


Measure the effects of tDCS on functional and sensory outcomes throughout the first year post onset of stroke.
METHODS


50 acute stroke patients were randomized and placed into either the treatment or sham group. Anodal tDCS was applied (2 mA, 20 min) 5 times a week during the first month post stroke. Patients were evaluated with the Wolf Motor Function Test, the Semmes Weinstein Monofilament Test, the Upper Extremity section (UEFM), the Lower Extremity section (LEFM) and the Somatosensory section of the Fugl Meyer Test, the Tardieu Spasticity Scale, the Stroke Impact Scale (SIS), the Hospital Anxiety and Depression Scale (HADS) and the Barthel Index. Evaluations were held at 48 h post stroke, week 1, 2, 3, 4, 3 months, 6 months and 1 year.
RESULTS


There were statistically and clinically significant improvements after tDCS in all functional motor outcomes, and somatosensory functions. Differences between both groups for the main outcome (WMFT time) were 51% (p = 0.04) at one month, and 57% (p = 0.02) at one year.
CONCLUSION


tDCS seems to be an effective adjuvant to conventional rehabilitation techniques. If applied in the acute stages of stroke, functional recovery is not only accelerated, but improved, and results are maintained up to one-year post stroke.",2020,"Differences between both groups for the main outcome (WMFT time) were 51% (p = 0.04) at one month, and 57% (p = 0.02) at one year.
","['acute stroke patients', '50 acute stroke patients']","['Anodal tDCS', 'Transcranial direct current stimulation associated with physical-therapy', 'tDCS']","['functional motor outcomes, and somatosensory functions', 'functional and sensory outcomes', 'Wolf Motor Function Test, the Semmes Weinstein Monofilament Test, the Upper Extremity section (UEFM), the Lower Extremity section (LEFM) and the Somatosensory section of the Fugl Meyer Test, the Tardieu Spasticity Scale, the Stroke Impact Scale (SIS), the Hospital Anxiety and Depression Scale (HADS) and the Barthel Index']","[{'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0325001', 'cui_str': 'Wolves'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0222045'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}]",,0.0437824,"Differences between both groups for the main outcome (WMFT time) were 51% (p = 0.04) at one month, and 57% (p = 0.02) at one year.
","[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bornheim', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Liege University Hospital Center, Liege, Belgium; Department of Sport and Rehabilitation Sciences, University of Liege, Liege, Belgium. Electronic address: Stephen.bornheim@ulg.ac.be.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Croisier', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Liege University Hospital Center, Liege, Belgium; Department of Sport and Rehabilitation Sciences, University of Liege, Liege, Belgium.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Maquet', 'Affiliation': 'Department of Neurology, Liege University Hospital Center, Liege, Belgium.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Kaux', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Liege University Hospital Center, Liege, Belgium; Department of Sport and Rehabilitation Sciences, University of Liege, Liege, Belgium.'}]",Brain stimulation,['10.1016/j.brs.2019.10.019']
548,32161164,Changes in mean arterial pressure and end-tidal carbon dioxide content affect venous sinus pressures in patients with idiopathic intracranial hypertension: a randomized study.,"INTRODUCTION


Little is known about how changes in physiologic parameters affect venous sinus pressure measurements, waveforms, or gradients associated with sinus stenosis.
OBJECTIVE


To evaluate the effect of changes in cardiovascular and respiratory physiologic parameters on venous sinus pressure and caliber measurements in patients with idiopathic intracranial hypertension (IIH) undergoing venous sinus stenting.
METHODS


In a prospective, randomized pilot study, eight patients with IIH undergoing venous sinus stenting were randomized to one of two groups. Under general anesthesia, patients underwent venous manometry and waveform recordings twice in succession based on assigned physiologic groups immediately before stenting. The mean arterial pressure (MAP) group maintained normocapnia but modified MAPs in two arms to control for temporal confounding: group A1 (MAP 60-80 mm Hg then 100-110 mm Hg) and group A2 (MAP 100-110 mm Hg then 60-80 mm Hg). The end-tidal carbon dioxide (EtCO 2 ) group maintained a high-normal MAP similar to standard neuroanesthesia goals and modified EtCO 2 : group B1 (EtCO 2  24-26 mm Hg then 38-40 mm Hg) and B2 (EtCO 2  28-40 mm Hg then 24-26 mm Hg).
RESULTS


In group A, superior sagittal sinus (SSS) pressures (ranging from 8 to 76 mm Hg) and trans-stenotic pressure gradients (TSPGs) (ranging from 2 to 67 mm Hg) were seen at MAP of 100-110 mm Hg compared with SSS pressures (4-38 mm Hg) and TSPGs (3-31 mm Hg) at 60-80 mm Hg. In group B, SSS pressures and TSPGs were considerably higher at EtCO 2  levels of 38-40 mm Hg (15-57 mm Hg and 3-44 mm Hg, respectively) than at 24-26 mm Hg (8-26 mm Hg and 1-8 mm Hg, respectively).
CONCLUSIONS


Despite the small sample size, this pilot study demonstrates a dramatic effect of both MAP and EtCO 2  on venous sinus pressures obtained during venography. These findings underscore the importance of maintaining normal physiologic cardiovascular and respiratory parameters during venous sinus manometry.",2020,"In group B, SSS pressures and TSPGs were considerably higher at EtCO 2  levels of 38-40 mm Hg (15-57 mm Hg and 3-44 mm Hg, respectively) than at 24-26 mm Hg (8-26 mm Hg and 1-8 mm Hg, respectively).
","['patients with idiopathic intracranial hypertension', 'eight patients with IIH undergoing venous sinus stenting', 'patients with idiopathic intracranial hypertension (IIH) undergoing venous sinus stenting']",['tidal carbon dioxide (EtCO 2 ) group maintained a high-normal MAP similar to standard neuroanesthesia goals and modified EtCO 2 : group B1 (EtCO 2  24-26 mm'],"['superior sagittal sinus (SSS) pressures', 'SSS pressures and TSPGs', 'mean arterial pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033845', 'cui_str': 'Idiopathic Intracranial Hypertension'}, {'cui': 'C0226504', 'cui_str': 'Structure of venous sinus'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0226859', 'cui_str': 'Sinus Sagittalis Superior'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",8.0,0.0565719,"In group B, SSS pressures and TSPGs were considerably higher at EtCO 2  levels of 38-40 mm Hg (15-57 mm Hg and 3-44 mm Hg, respectively) than at 24-26 mm Hg (8-26 mm Hg and 1-8 mm Hg, respectively).
","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tschoe', 'Affiliation': 'Department of Neurological Surgery, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA ctschoe@wakehealth.edu.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Garner', 'Affiliation': 'Department of Neurological Surgery, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Kittel', 'Affiliation': 'Division of Public Health Sciences, Department of Biostatistics, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Traunero', 'Affiliation': 'Department of Anesthesiology, Wake Forest University School of Medicine, Winston Salem, North Carolina, USA.'}, {'ForeName': 'Stacey Q', 'Initials': 'SQ', 'LastName': 'Wolfe', 'Affiliation': 'Department of Neurological Surgery, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Fargen', 'Affiliation': 'Department of Neurological Surgery, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2019-015741']
549,32161969,Vaccination With Moderate Coverage Eradicates Oncogenic Human Papillomaviruses If a Gender-Neutral Strategy Is Applied.,"BACKGROUND


Human papillomavirus (HPV) vaccination of girls with very high (>90%) coverage has the potential to eradicate oncogenic HPVs, but such high coverage is hard to achieve. However, the herd effect (HE) depends both on the HPV type and the vaccination strategy.
METHODS


We randomized 33 Finnish communities into gender-neutral HPV16/18 vaccination, girls-only HPV16/18 vaccination, and hepatitis B virus vaccination arms. In 2007-2010, 11 662 of 20 513 of 40 852 of 39 420 resident boys/girls from 1992 to 1995 birth cohorts consented. In 2010-2014, cervicovaginal samples from vaccinated and unvaccinated girls at age 18.5 years were typed for HPV6/11/16/18/31/33/35/39/45/51/52/56/58/59/66/68. Vaccine efficacy for vaccinated girls, HE for unvaccinated girls, and the protective effectiveness (PE) for all girls were estimated. We extended the community-randomized trial results about vaccination strategy with mathematical modeling to assess HPV eradication.
RESULTS


The HE and PE estimates in the 1995 birth cohort for HPV18/31/33 were significant in the gender-neutral arm and 150% and 40% stronger than in the girls-only arm. Concordantly, HPV18/31/33 eradication was already predicted in adolescents/young adults in 20 years with 75% coverage of gender-neutral vaccination. With the 75% coverage, eventual HPV16 eradication was also predicted, but only with the gender-neutral strategy.
CONCLUSIONS


Gender-neutral vaccination is superior for eradication of oncogenic HPVs.",2020,"The HE and PE estimates in the 1995 birth cohort for HPV18/31/33 were significant in the gender-neutral arm, and 150% and 40% stronger than in the girls-only arm.","['In 2007-2010, 11,662/20,513 of 40,852/39,420 resident boys/girls from 1992-1995 birth cohorts consented', 'adolescents/young adults in already 20 years with 75% coverage of gender-neutral vaccination', 'vaccinated girls, HE for unvaccinated girls', '33 Finnish communities into gender-neutral HPV16/18 vaccination, girls-only HPV16/18 vaccination, and hepatitis B-virus vaccination arms', 'In 2010-14, cervicovaginal samples from vaccinated and unvaccinated girls at age 18.5 years were typed for HPV6/11/16/18/31/33/35/39/45/51/52/56/58/59/66/68', 'girls with very high (>90%) coverage']",[],"['eventual HPV16 eradication', 'Vaccine efficacy (VE', 'HE and PE estimates']","[{'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C0439083', 'cui_str': '>90 (qualifier value)'}]",[],"[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",33.0,0.111656,"The HE and PE estimates in the 1995 birth cohort for HPV18/31/33 were significant in the gender-neutral arm, and 150% and 40% stronger than in the girls-only arm.","[{'ForeName': 'Simopekka', 'Initials': 'S', 'LastName': 'Vänskä', 'Affiliation': 'Infectious Disease Control and Vaccinations, Finnish Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Tapio', 'Initials': 'T', 'LastName': 'Luostarinen', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Baussano', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Apter', 'Affiliation': 'VL-Medi Oy, Helsinki, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Eriksson', 'Affiliation': 'Tampere University, Tampere, Finland.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Natunen', 'Affiliation': 'Tampere University, Tampere, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Nieminen', 'Affiliation': 'University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jorma', 'Initials': 'J', 'LastName': 'Paavonen', 'Affiliation': 'University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Ville N', 'Initials': 'VN', 'LastName': 'Pimenoff', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Eero', 'Initials': 'E', 'LastName': 'Pukkala', 'Affiliation': 'Tampere University, Tampere, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Söderlund-Strand', 'Affiliation': 'Department of Clinical Microbiology, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Dubin', 'Affiliation': 'Takeda Pharmaceuticals International, Zurich, Switzerland.'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Garnett', 'Affiliation': 'Gates Foundation, Seattle, Washington, USA.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Dillner', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Lehtinen', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa099']
550,31964564,"A Novel Approach to Postpartum Contraception Provision Combined with Infant Care: A Randomized, Controlled Trial.","BACKGROUND


Unintended pregnancy among women with short interpregnancy intervals remains common. Women's attendance at the 4- to 6-week postpartum visit, when contraception provision often occurs, is low, whereas their attendance at well-baby visits is high. We aimed to evaluate if offering co-located contraceptive services to mothers at well-baby visits increases use of long-acting reversible contraception (LARC) at 5 months postpartum compared with usual care in a randomized, controlled trial.
METHODS


Women with infants aged 4.5 months or younger who were not using a LARC method and had not undergone sterilization were eligible. Generalized linear models were used to estimate risk ratios. Likability and satisfaction of the contraception visit were assessed.
RESULTS


Between January 2015 and January 2017, 446 women were randomized. LARC use at 5 months was 19.1% and 20.9% for the intervention and control groups, respectively, and was not significantly different after controlling for weeks postpartum (risk ratio, 0.85; 95% confidence interval, 0.59-1.23). Uptake of the co-located visit was low (17.7%), but the concept was liked; insufficient time to stay for the visit was the biggest barrier to uptake. Women who accepted the visit were more likely to use a LARC method at 5 months compared with women in the control group (risk ratio, 1.97; 95% confidence interval, 1.26-3.07).
CONCLUSIONS


Women perceived co-located care favorably and LARC use was higher among those who completed a visit; however, uptake was low for reasons including inability to stay after the infant visit. Intervention effects were possibly diluted. Future research should test a version of this intervention designed to overcome barriers that participants reported.",2020,"Women who accepted the visit were more likely to use a LARC method at 5 months compared with women in the control group (risk ratio, 1.97; 95% confidence interval, 1.26-3.07).
","['Between January 2015 and January 2017, 446 women were randomized', 'Women with infants aged 4.5\xa0months or younger who were not using a LARC method and had not undergone sterilization were eligible', ""Women's attendance at""]","['Combined with Infant Care', 'long-acting reversible contraception (LARC', 'Postpartum Contraception Provision']",['Likability and satisfaction of the contraception visit'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0362065', 'cui_str': 'Sterilization'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0021272', 'cui_str': 'Infant Care'}, {'cui': 'C4505307', 'cui_str': 'Long-Acting Reversible Contraception'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}]",446.0,0.237738,"Women who accepted the visit were more likely to use a LARC method at 5 months compared with women in the control group (risk ratio, 1.97; 95% confidence interval, 1.26-3.07).
","[{'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Haider', 'Affiliation': 'The University of Illinois at Chicago, Chicago, Illinois. Electronic address: shaider2@bsd.uchicago.edu.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Stoffel', 'Affiliation': 'The University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rankin', 'Affiliation': 'The University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Keriann', 'Initials': 'K', 'LastName': 'Uesugi', 'Affiliation': 'The University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Arden', 'Initials': 'A', 'LastName': 'Handler', 'Affiliation': 'The University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Caskey', 'Affiliation': 'The University of Illinois at Chicago, Chicago, Illinois.'}]",Women's health issues : official publication of the Jacobs Institute of Women's Health,['10.1016/j.whi.2019.12.001']
551,31638902,A four-stage process for intervention description and guide development of a practice-based intervention: refining the Namaste Care intervention implementation specification for people with advanced dementia prior to a feasibility cluster randomised trial.,"BACKGROUND


Some interventions are developed from practice, and implemented before evidence of effect is determined, or the intervention is fully specified. An example is Namaste Care, a multi-component intervention for people with advanced dementia, delivered in care home, community, hospital and hospice settings. This paper describes the development of an intervention description, guide and training package to support implementation of Namaste Care within the context of a feasibility trial. This allows fidelity to be determined within the trial, and for intervention users to understand how similar their implementation is to that which was studied.
METHODS


A four-stage approach: a) Collating existing intervention materials and drawing from programme theory developed from a realist review to draft an intervention description. b) Exploring readability, comprehensibility and utility with staff who had not experienced Namaste Care. c) Using modified nominal group techniques with those with Namaste Care experience to refine and prioritise the intervention implementation materials. d) Final refinement with a patient and public involvement panel.
RESULTS


Eighteen nursing care home staff, one carer, one volunteer and five members of our public involvement panel were involved across the study steps. A 16-page A4 booklet was designed, with flow charts, graphics and colour coded information to ease navigation through the document. This was supplemented by infographics, and a training package. The guide describes the boundaries of the intervention and how to implement it, whilst retaining the flexible spirit of the Namaste Care intervention.
CONCLUSIONS


There is little attention paid to how best to specify complex interventions that have already been organically implemented in practice. This four-stage process may have utility for context specific adaptation or description of existing, but untested, interventions. A robust, agreed, intervention and implementation description should enable a high-quality future trial. If an effect is determined, flexible practice implementation should be enabled through having a clear, evidence-based guide.",2019,"An example is Namaste Care, a multi-component intervention for people with advanced dementia, delivered in care home, community, hospital and hospice settings.","['people with advanced dementia prior', 'people with advanced dementia', 'Eighteen nursing care home staff, one carer, one volunteer and five members of our public involvement panel were involved across the study steps']",['Namaste Care intervention implementation specification'],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0450059', 'cui_str': 'Member of public (person)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}]",[],[],,0.0615216,"An example is Namaste Care, a multi-component intervention for people with advanced dementia, delivered in care home, community, hospital and hospice settings.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Walshe', 'Affiliation': 'International Observatory on End of Life Care, Faculty of Health and Medicine, Lancaster University, Lancaster, LA1 4YG, UK. c.walshe@lancaster.ac.uk.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kinley', 'Affiliation': ""St Christopher's Hospice, 51-59 Lawrie Park Road, Sydenham, London, SE26 6DZ, UK.""}, {'ForeName': 'Shakil', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'International Observatory on End of Life Care, Faculty of Health and Medicine, Lancaster University, Lancaster, LA1 4YG, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Goodman', 'Affiliation': 'Centre for Research in Public Health and Community Care, University of Hertfordshire, College Lane, Hatfield, Hertfordshire, AL10 9AB, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Bunn', 'Affiliation': 'Centre for Research in Public Health and Community Care, University of Hertfordshire, College Lane, Hatfield, Hertfordshire, AL10 9AB, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'Centre for Research in Public Health and Community Care, University of Hertfordshire, College Lane, Hatfield, Hertfordshire, AL10 9AB, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scott', 'Affiliation': ""Patient Representative c/o The Alzheimer's Society, London, UK.""}, {'ForeName': 'Anne Davidson', 'Initials': 'AD', 'LastName': 'Lund', 'Affiliation': ""Patient Representative c/o The Alzheimer's Society, London, UK.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Stacpoole', 'Affiliation': ""St Christopher's Hospice, 51-59 Lawrie Park Road, Sydenham, London, SE26 6DZ, UK.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Preston', 'Affiliation': 'International Observatory on End of Life Care, Faculty of Health and Medicine, Lancaster University, Lancaster, LA1 4YG, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Froggatt', 'Affiliation': 'International Observatory on End of Life Care, Faculty of Health and Medicine, Lancaster University, Lancaster, LA1 4YG, UK.'}]",BMC geriatrics,['10.1186/s12877-019-1275-z']
552,31434094,Effect of A Randomized trial of Unruptured Brain Arteriovenous Malformation on Interventional Treatment Rates for Unruptured Arteriovenous Malformations.,"BACKGROUND


In 2013, investigators from A Randomized Trial of Unruptured Brain Arteriovenous Malformations (AVM; ARUBA) reported that interventions to obliterate unruptured AVMs caused more morbidity and mortality than medical management.
OBJECTIVE


We sought to determine whether interventions for unruptured AVM decreased after publication of ARUBA results.
METHODS


We used the Nationwide Readmissions Database to assess trends in interventional AVM management in patients ≥18 years of age from 2010 through 2015. Unruptured brain AVMs were identified using International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) code 747.81 and excluding any patient with a diagnosis of intracranial hemorrhage. Our primary outcome was interventional AVM treatment, identified using ICD-9-CM procedure codes for surgical resection, endovascular therapy, and stereotactic radiosurgery. Join-point regression was used to assess trends in the incidence of interventional AVM management among adults from 2010 through 2015.
RESULTS


There was no significant U.S. population level change in unruptured brain AVM intervention rates before versus after ARUBA (p = 0.59), with the incidence of AVM intervention ranging from 8.0 to 9.2 per 10 million U.S. residents before the trial publication to 7.7-8.3 per 10 million afterwards.
CONCLUSIONS


In a nationally representative sample, we found no change in rates of interventional unruptured AVM management after publication of the ARUBA trial results.",2019,"There was no significant U.S. population level change in unruptured brain AVM intervention rates before versus after ARUBA (p = 0.59), with the incidence of AVM intervention ranging from 8.0 to 9.2 per 10 million U.S. residents before the trial publication to 7.7-8.3 per 10 million afterwards.
","['Unruptured Arteriovenous Malformations', 'patients ≥18 years of age from 2010 through 2015', 'adults from 2010 through 2015']",['Unruptured Brain Arteriovenous Malformation'],"['ICD-9-CM procedure codes for surgical resection, endovascular therapy, and stereotactic radiosurgery', 'unruptured brain AVM intervention rates']","[{'cui': 'C0003857', 'cui_str': 'Arteriovenous Malformations'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0003857', 'cui_str': 'Arteriovenous Malformations'}]","[{'cui': 'C1137112', 'cui_str': 'ICD-9-CM'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3846112', 'cui_str': 'Radiosurgery, Stereotactic'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]",,0.0833206,"There was no significant U.S. population level change in unruptured brain AVM intervention rates before versus after ARUBA (p = 0.59), with the incidence of AVM intervention ranging from 8.0 to 9.2 per 10 million U.S. residents before the trial publication to 7.7-8.3 per 10 million afterwards.
","[{'ForeName': 'Alexandra S', 'Initials': 'AS', 'LastName': 'Reynolds', 'Affiliation': 'Department of Neurology, Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute, New York, New York, USA.'}, {'ForeName': 'Monica L', 'Initials': 'ML', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute, New York, New York, USA.'}, {'ForeName': 'Alexander E', 'Initials': 'AE', 'LastName': 'Merkler', 'Affiliation': 'Department of Neurology, Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute, New York, New York, USA.'}, {'ForeName': 'Abhinaba', 'Initials': 'A', 'LastName': 'Chatterjee', 'Affiliation': 'Department of Neurology, Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute, New York, New York, USA.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Díaz', 'Affiliation': 'Department of Neurology, Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute, New York, New York, USA.'}, {'ForeName': 'Babak B', 'Initials': 'BB', 'LastName': 'Navi', 'Affiliation': 'Department of Neurology, Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute, New York, New York, USA.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Kamel', 'Affiliation': 'Department of Neurology, Clinical and Translational Neuroscience Unit, Feil Family Brain and Mind Research Institute, New York, New York, USA, hok9010@med.cornell.edu.'}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000502314']
553,32056146,"Self-Monitoring and Management of Blood Pressure in Patients with Stroke or TIA: An Economic Evaluation of TEST-BP, A Randomised Controlled Trial.","BACKGROUND


Prevention of secondary stroke following initial ictus is an important focus of after-stroke care. Blood pressure (BP) is a key risk factor, so usual care following stroke or transient ischaemic attack includes regular BP checks and monitoring of anti-hypertensive medication. This is traditionally carried out in primary care, but the evidence supporting self-monitoring and self-guided management of BP in the general population with hypertension is growing.
OBJECTIVE


Our objective was to estimate the cost effectiveness of treatment as usual (TAU) versus (1) self-monitoring of BP (S-MON) and (2) self-monitoring and guided self-management of anti-hypertensive medication (S-MAN).
METHODS


This was a within-trial economic evaluation of a randomised controlled trial estimating the incremental cost per 1 mmHg BP reduction and per quality-adjusted life-year (QALY) gained over a 6-month time horizon from the perspective of the UK National Health Service (NHS).
RESULTS


Data were evaluable for 140 participants. Costs per patient were £473, £853 and £1035; mean reduction in systolic BP (SBP) was 3.6, 6.7 and 6.1 mmHg, and QALYs accrued were 0.427, 0.422 and 0.423 for TAU, S-MON and S-MAN, respectively. No statistically significant differences in incremental costs or outcomes were detected. On average, S-MAN was dominated or extended dominated. The incremental cost per 1 mmHg BP reduction from S-MON versus TAU was £137.
CONCLUSION


On average, S-MAN is an inefficient intervention. S-MON may be cost effective, depending on the willingness to pay for a 1 mmHg BP reduction, although it yielded fewer QALYs over the within-trial time horizon. Decision modelling is required to explore the longer-term costs and outcomes.",2020,"Costs per patient were £473, £853 and £1035; mean reduction in systolic BP (SBP) was 3.6, 6.7 and 6.1 mmHg, and QALYs accrued were 0.427, 0.422 and 0.423 for TAU, S-MON and S-MAN, respectively.","['Data were evaluable for 140 participants', 'Patients with Stroke or TIA']","['Self-Monitoring and Management of Blood Pressure', 'usual (TAU) versus (1) self-monitoring of BP (S-MON) and (2) self-monitoring and guided self-management of anti-hypertensive medication (S-MAN']","['incremental cost per 1\xa0mmHg BP reduction and per quality-adjusted life-year (QALY', 'Blood pressure (BP', 'systolic BP (SBP', 'incremental costs or outcomes']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}]","[{'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",,0.107845,"Costs per patient were £473, £853 and £1035; mean reduction in systolic BP (SBP) was 3.6, 6.7 and 6.1 mmHg, and QALYs accrued were 0.427, 0.422 and 0.423 for TAU, S-MON and S-MAN, respectively.","[{'ForeName': 'Lois G', 'Initials': 'LG', 'LastName': 'Kim', 'Affiliation': 'Cambridge Centre for Health Services Research, Institute of Public Health, University of Cambridge School of Clinical Medicine, Forvie Site, Cambridge, UK.'}, {'ForeName': 'Edward C F', 'Initials': 'ECF', 'LastName': 'Wilson', 'Affiliation': 'Cambridge Centre for Health Services Research, Institute of Public Health, University of Cambridge School of Clinical Medicine, Forvie Site, Cambridge, UK. ed.wilson@uea.ac.uk.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Davison', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Allan B', 'Initials': 'AB', 'LastName': 'Clark', 'Affiliation': 'Medical Statistics Group, Norwich Medical School, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Phyo K', 'Initials': 'PK', 'LastName': 'Myint', 'Affiliation': 'Ageing Clinical and Experimental Research (ACER), Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Potter', 'Affiliation': 'Ageing and Stroke Medicine, Norwich Medical School, University of East Anglia, Norwich, UK.'}]",PharmacoEconomics - open,['10.1007/s41669-020-00196-w']
554,31145699,A randomized 3-way crossover study indicates that high-protein feeding induces de novo lipogenesis in healthy humans.,"BACKGROUNDDietary changes have led to the growing prevalence of type 2 diabetes and nonalcoholic fatty liver disease. A hallmark of both disorders is hepatic lipid accumulation, derived in part from increased de novo lipogenesis. Despite the popularity of high-protein diets for weight loss, the effect of dietary protein on de novo lipogenesis is poorly studied. We aimed to characterize the effect of dietary protein on de novo lipid synthesis.METHODSWe use a 3-way crossover interventional study in healthy males to determine the effect of high-protein feeding on de novo lipogenesis, combined with in vitro models to determine the lipogenic effects of specific amino acids. The primary outcome was a change in de novo lipogenesis-associated triglycerides in response to protein feeding.RESULTSWe demonstrate that high-protein feeding, rich in glutamate, increases de novo lipogenesis-associated triglycerides in plasma (1.5-fold compared with control; P < 0.0001) and liver-derived very low-density lipoprotein particles (1.8-fold; P < 0.0001) in samples from human subjects (n = 9 per group). In hepatocytes, we show that glutamate-derived carbon is incorporated into triglycerides via palmitate. In addition, supplementation with glutamate, glutamine, and leucine, but not lysine, increased triglyceride synthesis and decreased glucose uptake. Glutamate, glutamine, and leucine increased activation of protein kinase B, suggesting that induction of de novo lipogenesis occurs via the insulin signaling cascade.CONCLUSIONThese findings provide mechanistic insight into how select amino acids induce de novo lipogenesis and insulin resistance, suggesting that high-protein feeding to tackle diabetes and obesity requires greater consideration.FUNDINGThe research was supported by UK Medical Research Council grants MR/P011705/1, MC_UP_A090_1006 and MR/P01836X/1. JLG is supported by the Imperial Biomedical Research Centre, National Institute for Health Research (NIHR).",2019,"In addition, supplementation with glutamate, glutamine, and leucine, but not lysine, increased triglyceride synthesis and decreased glucose uptake.","['healthy humans', 'healthy males']","['JLG', 'dietary protein']","['de novo lipogenesis-associated triglycerides in plasma', 'triglyceride synthesis and decreased glucose uptake', 'change in de novo lipogenesis-associated triglycerides in response to protein feeding']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0012177', 'cui_str': 'Dietary Proteins'}]","[{'cui': 'C1563744', 'cui_str': 'Lipogenesis'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",,0.0212108,"In addition, supplementation with glutamate, glutamine, and leucine, but not lysine, increased triglyceride synthesis and decreased glucose uptake.","[{'ForeName': 'Evelina', 'Initials': 'E', 'LastName': 'Charidemou', 'Affiliation': 'Department of Biochemistry and Cambridge Systems Biology Centre, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Ashmore', 'Affiliation': 'Department of Biochemistry and Cambridge Systems Biology Centre, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Xuefei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Biochemistry and Cambridge Systems Biology Centre, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Ben D', 'Initials': 'BD', 'LastName': 'McNally', 'Affiliation': 'Department of Biochemistry and Cambridge Systems Biology Centre, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'West', 'Affiliation': ""Division of Gastroenterology and Hepatology, Department of Medicine, Addenbrooke's Hospital, University of Cambridge, Cambridge, United Kingdom.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Liggi', 'Affiliation': 'Department of Biochemistry and Cambridge Systems Biology Centre, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Harvey', 'Affiliation': 'Medical Research Council - Elsie Widdowson Laboratory, Cambridge, United Kingdom.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Orford', 'Affiliation': 'Medical Research Council - Elsie Widdowson Laboratory, Cambridge, United Kingdom.'}, {'ForeName': 'Julian L', 'Initials': 'JL', 'LastName': 'Griffin', 'Affiliation': 'Department of Biochemistry and Cambridge Systems Biology Centre, University of Cambridge, Cambridge, United Kingdom.'}]",JCI insight,['10.1172/jci.insight.124819']
555,31399446,"Effectiveness and safety of Chinese herbal medicine xuanbi antong granules for the treatment of borderline coronary lesions: study protocol for a randomised, double-blinded, placebo-controlled, multicentre clinical trial.","INTRODUCTION


As the early stage of coronary heart disease (CHD), borderline coronary lesion (BCL) is defined as a 30%-70% diameter stenosis. Previous studies have demonstrated that BCL may progress to acute coronary syndrome easily. However, routine medications available for the treatments of BCL have some limitations. Xuanbi antong granule (XAG) has been used for the treatment of BCL in China for many years. Previous studies have shown that XAG has effectiveness in improving clinical symptoms and quality of life in patients with CHD. This study aims to evaluate the effectiveness and safety of XAG in patients with BCL.
METHODS AND ANALYSIS


This is a multicentre, randomised, double-blinded, placebo-controlled clinical trial. A total of 300 participants will be randomly assigned to the intervention group and the placebo group. Based on routine medications, the intervention group will be treated with XAG and the placebo group will be treated with XAG placebo. All participants will receive a 6-month treatment and then be followed-up for another 6 months. The primary outcomes are the changes of target plaque characteristics (including target plaque volume, degree of stenosis, CT value and calcification score) measured by dual source CT angiography. The secondary outcomes include blood lipid indicators, efficacy of angina symptoms, Seattle Angina Questionnaire, high-sensitivity C-reactive protein and occurrence of major adverse cardiac events. All the data will be recorded in electronic case report forms and analysed by SPSS V.20.0.
ETHICS AND DISSEMINATION


This study has been approved by Research Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2017-083-KY-01). Written informed consent will be obtained from all participants. The results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.
TRIAL REGISTRATION NUMBER


ChiCTR-IOR-17013189; Pre-results.",2019,Xuanbi antong granule (XAG) has been used for the treatment of BCL in China for many years.,"['300 participants', 'patients with BCL', 'patients with CHD', 'borderline coronary lesions']","['XAG', 'placebo', 'XAG placebo', 'Xuanbi antong granule (XAG', 'Chinese herbal medicine xuanbi antong granules', 'BCL']","['blood lipid indicators, efficacy of angina symptoms, Seattle Angina Questionnaire, high-sensitivity C-reactive protein and occurrence of major adverse cardiac events', 'Effectiveness and safety', 'changes of target plaque characteristics (including target plaque volume, degree of stenosis, CT value and calcification score', 'clinical symptoms and quality of life']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3853573', 'cui_str': 'Granules'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}]","[{'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034380'}]",300.0,0.408143,Xuanbi antong granule (XAG) has been used for the treatment of BCL in China for many years.,"[{'ForeName': 'Mingyan', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Qingya', 'Initials': 'Q', 'LastName': 'Guan', 'Affiliation': 'Graduate School, Hubei University of Chinese Medicine, Wuhan, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': ""Department of Radiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Kuiwu', 'Initials': 'K', 'LastName': 'Yao', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Zhenpeng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Haoqiang', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China.'}, {'ForeName': 'Xinhui', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming, China.'}, {'ForeName': 'Yongmei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Molecular Biology Laboratory, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Xing-Jiang', 'Initials': 'XJ', 'LastName': 'Xiong', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Clinicial Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}]",BMJ open,['10.1136/bmjopen-2018-024968']
556,32152770,Laparoscopic multivisceral resection for locally advanced colon cancer: a single-center analysis of short- and long-term outcomes.,"PURPOSE


We evaluated the technical and oncological safety of laparoscopic multivisceral resection (MVR) in selected patients with locally advanced colon cancer (LACC).
METHODS


We compared the clinical backgrounds, and short- and long-term outcomes of patients who underwent laparoscopic vs. those who underwent open MVR for LACC en bloc at our hospital.
RESULTS


Between January, 2004 and December, 2015, 140 patients underwent MVR of the primary tumor en bloc via laparoscopic surgery (laparoscopic group; LG, n = 69) or open surgery (open group; OG, n = 71). Laparoscopic surgery was selected mainly for tumors that invaded the bladder and abdominal wall. The LG patients had smaller tumors (60 vs. 80 mm, p < 0.001), less blood loss (30 vs. 181 g, p < 0.001), and shorter hospital stays (12 vs. 19 days, p < 0.001) than the OG patients. Open conversion was required for two patients. Postoperative complications and R0 resection were comparable between the groups. Local recurrence occurred in two LG patients and two OG patients. The 5-year cancer-specific survival, disease-free survival, and local disease-free survival of patients with pT4b disease were not significantly different between the LG and OG groups (90.3% vs. 75.2%, 71.2% vs. 67.6%, and 97.1% vs. 94.2%).
CONCLUSION


Although the LG included patients with lower risk, the short- and long-term outcomes were equivalent to those of the OG, which included patients with higher risk.",2020,"The LG patients had smaller tumors (60 vs. 80 mm, p < 0.001), less blood loss (","['patients who underwent laparoscopic vs. those who underwent open MVR for LACC en bloc at our hospital', 'selected patients with locally advanced colon cancer (LACC', '30 vs. 181', 'Between January, 2004 and December, 2015, 140 patients underwent MVR of the primary tumor en bloc via', 'locally advanced colon cancer']","['laparoscopic multivisceral resection (MVR', 'Laparoscopic surgery', 'Laparoscopic multivisceral resection', 'laparoscopic surgery (laparoscopic group; LG, n\u2009=\u200969) or open surgery']","['Local recurrence', '5-year cancer-specific survival, disease-free survival, and local disease-free survival of patients with pT4b disease', 'Postoperative complications and R0 resection', 'shorter hospital stays', 'blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0277565', 'cui_str': 'Localized disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",,0.0571524,"The LG patients had smaller tumors (60 vs. 80 mm, p < 0.001), less blood loss (","[{'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Mukai', 'Affiliation': 'Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-10-6 Ariake, Koto-ku, Tokyo, 135-8550, Japan. toshiki.mukai@jfcr.or.jp.'}, {'ForeName': 'Toshiya', 'Initials': 'T', 'LastName': 'Nagasaki', 'Affiliation': 'Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-10-6 Ariake, Koto-ku, Tokyo, 135-8550, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Akiyoshi', 'Affiliation': 'Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-10-6 Ariake, Koto-ku, Tokyo, 135-8550, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Fukunaga', 'Affiliation': 'Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-10-6 Ariake, Koto-ku, Tokyo, 135-8550, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-10-6 Ariake, Koto-ku, Tokyo, 135-8550, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Konishi', 'Affiliation': 'Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-10-6 Ariake, Koto-ku, Tokyo, 135-8550, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Nagayama', 'Affiliation': 'Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-10-6 Ariake, Koto-ku, Tokyo, 135-8550, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Ueno', 'Affiliation': 'Department of Gastroenterological Surgery, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-10-6 Ariake, Koto-ku, Tokyo, 135-8550, Japan.'}]",Surgery today,['10.1007/s00595-020-01986-9']
557,32028023,Topical 5% minoxidil versus topical 0.2% glyceryl trinitrate in treatment of chronic anal fissure: A randomized clinical trial.,"BACKGROUND


Chronic anal fissure (CAF) is a common painful anal condition. Medical treatment of CAF involves the use of agents that induce chemical sphincterotomy. The present trial aimed to compare the efficacy and safety of topical minoxidil and glyceryl trinitrate (GTN) preparations in treatment of CAF.
METHODS


Adult patients with CAF were randomly assigned to one of two equal groups; group I received topical 5% minoxidil gel and group II received topical 0.2% GTN cream. The main outcome measures were healing of anal fissure, duration to healing, relief of symptoms, and adverse effects.
RESULTS


62 patients (36 female and 26 male) were included to the study. Group I comprised 30 patients and group II comprised 32 patients. Healing of anal fissure was achieved in 23 (76.7%) patients in group I and 15 (46.9%) patients in group II (p = 0.03). The average duration to healing in group I was significantly shorter than group II (4.1 ± 1.9 vs 5.3 ± 2.7 weeks, p = 0.048). Adverse effects were recorded in 2 (6.6%) patients in group I and 13 (40.6%) patients in group II. The post-treatment pain score in the GTN group was significantly lower than the Minoxidil group.
CONCLUSION


Topical 5% minoxidil gel achieved greater and quicker healing of CAF and fewer adverse effects than topical 0.2% GTN cream. Post-treatment pain scores after GTN were significantly lower than minoxidil.
TRIAL REGISTRATION NUMBER


NCT03528772.",2020,Healing of anal fissure was achieved in 23 (76.7%) patients in group,"['Chronic Anal Fissure', '62 patients (36 female and 26 male', 'Adult patients with CAF']","['Minoxidil', 'topical 5% minoxidil gel and group II received topical 0.2% GTN cream', 'minoxidil', 'CAF', 'minoxidil gel', 'Topical 5% Minoxidil versus Topical 0.2% Glyceryl Trinitrate', 'topical minoxidil and glyceryl trinitrate (GTN']","['healing of anal fissure, duration to healing, relief of symptoms, and adverse effects', 'average duration to healing', 'efficacy and safety', 'adverse effects', 'Adverse effects', 'Healing of anal fissure', 'post-treatment pain score', 'pain scores', 'quicker healing of CAF']","[{'cui': 'C0349071', 'cui_str': 'Chronic anal fissure (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0016167', 'cui_str': 'Anal Fissure'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1291732', 'cui_str': 'Treatment pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",62.0,0.0357327,Healing of anal fissure was achieved in 23 (76.7%) patients in group,"[{'ForeName': 'Sameh Hany', 'Initials': 'SH', 'LastName': 'Emile', 'Affiliation': 'Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: sameh200@hotmail.com.'}, {'ForeName': 'Mohamed Anwar', 'Initials': 'MA', 'LastName': 'Abdel-Razik', 'Affiliation': 'Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: drmohamedanwar1981@yahoo.com.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Elshobaky', 'Affiliation': 'Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: elshobakyayman@yahoo.com.'}, {'ForeName': 'Samy Abbas', 'Initials': 'SA', 'LastName': 'Elbaz', 'Affiliation': 'Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: sami_mrcsed@yahoo.com.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Khafagy', 'Affiliation': 'Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: wkhafagy@yahoo.com.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Shalaby', 'Affiliation': 'Colorectal Surgery Unit, Department of General Surgery, Mansoura Faculty of Medicine, Mansoura University, Mansoura, Egypt. Electronic address: mostafashalaby@mans.edu.eg.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.01.143']
558,32152513,Effects of substituting eggs for high-carbohydrate breakfast foods on the cardiometabolic risk-factor profile in adults at risk for type 2 diabetes mellitus.,"OBJECTIVES


To assess effects of egg-based versus non-egg, higher-carbohydrate (CHO) breakfast meals on cardiometabolic health markers in overweight or obese adults with prediabetes and/or metabolic syndrome.
METHODS


This randomized, crossover study included two 4-week dietary interventions, separated by a ≥4-week washout. Subjects incorporated into their habitual diets breakfast meals containing either 2 eggs/day for 6 days/week (Egg condition), or energy-matched, non-egg, higher-CHO-based foods (Non-Egg condition). Dietary intakes, insulin sensitivity, and other CHO metabolism indices, lipid biomarkers, high-sensitivity C-reactive protein, and blood pressures were measured.
RESULTS


Thirty men and women with mean age 54.1 ± 1.9 years and body mass index 31.9 ± 0.7 kg/m 2  provided data. Neither diet condition significantly altered insulin sensitivity indices, but the homeostasis model assessment for insulin resistance was significantly (p = 0.028) higher after the Non-Egg vs. the Egg condition. Low-density lipoprotein cholesterol (LDL-C) was decreased from baseline (119 mg/dL) by 2.9 and 6.0% with Egg and Non-Egg breakfasts, respectively (p = 0.023). Systolic blood pressure was reduced from baseline (127 mm Hg) by 2.7 and 0.0% with Egg and Non-Egg, respectively (p = 0.018). Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
CONCLUSION


Compared with the baseline diet, consumption of 12 eggs/week for 4 weeks at breakfast was associated with less reduction in LDL-C, and more lowering of systolic blood pressure, than observed with non-egg-based, energy-matched, control foods higher in CHO.",2020,"Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
","['overweight or obese adults with prediabetes and/or metabolic syndrome', 'Thirty men and women with mean age 54.1\u2009±\u20091.9\u2009years and body mass index 31.9\u2009±\u20090.7\u2009kg/m 2  provided data', 'adults at risk for type 2 diabetes mellitus']","['egg-based versus non-egg, higher-carbohydrate (CHO) breakfast meals']","['lowering of systolic blood pressure', 'Systolic blood pressure', 'Low-density lipoprotein cholesterol (LDL-C', 'Dietary intakes, insulin sensitivity, and other CHO metabolism indices, lipid biomarkers, high-sensitivity C-reactive protein, and blood pressures', 'weight change', 'cardiometabolic risk-factor profile', 'insulin sensitivity indices', 'homeostasis model assessment for insulin resistance', 'cardiometabolic health markers']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0693838,"Diet records indicated 149 kcal/day higher (p = 0.008) energy intake from non-study foods during the Egg condition; however, weight change from baseline did not differ between conditions.
","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA. kmaki@mbclinicalresearch.com.'}, {'ForeName': 'Orsolya M', 'Initials': 'OM', 'LastName': 'Palacios', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}, {'ForeName': 'Melvyn W', 'Initials': 'MW', 'LastName': 'Kramer', 'Affiliation': 'MB Clinical Research, Boca Raton, FL, USA.'}, {'ForeName': 'Rupal', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'Great Lakes Clinical Trials, Chicago, IL, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Wilcox', 'Affiliation': 'MB Clinical Research, Boca Raton, FL, USA.'}, {'ForeName': 'Cathleen E', 'Initials': 'CE', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, IL, USA.'}]",European journal of clinical nutrition,['10.1038/s41430-020-0599-2']
559,31439593,"Treating gambling disorder with as needed administration of intranasal naloxone: a pilot study to evaluate acceptability, feasibility and outcomes.","BACKGROUND AND AIM


There is growing interest in the use of medication-assisted treatments for gambling disorder (GD). Opioid receptor antagonists are hypothesised to blunt the craving associated with gambling. This study was designed to assess the feasibility of using an intranasal naloxone spray to treat GD.
DESIGN


An 8-week, open-label, uncontrolled pilot study.
SETTING


A single study site in the capital region of Finland.
SUBJECTS


Twenty problem gamblers (nine men) were randomised into two groups. Group A (n=10) took one dose into one nostril (2 mg naloxone), as needed, with a maximum of 4 doses/day (max. 8 mg/day). Group B (n=10) took one dose into each nostril (4 mg naloxone) as needed, with a maximum of 4 doses/day (max. 16 mg/day).
INTERVENTION


Naloxone hydrochloride nasal spray.
MEASURES


Acceptability and feasibility of the intervention were assessed. Use of study medication, adverse events, gambling frequency and gambling expenditure were recorded in a mobile diary. Problem gambling: South Oaks Gambling Screen (SOGS), depressive symptoms: Beck Depression Inventory (BDI) and alcohol use: Alcohol Use Disorders Identification Test were recorded.
RESULTS


Study completion rate was 90%. Acceptability and feasibility scores were high. Group B used intranasal naloxone more frequently than group A, and consequently used more naloxone. No serious adverse events were reported. The postintervention SOGS scores were lower (median=4 (IQR=3.75) versus preintervention scores (median=12 (IQR=4.75)). Depressive symptoms were reduced during the trial (preintervention BDI median=9, IQR=9 vs postintervention BDI median=6, IQR=6).
CONCLUSIONS


The acceptability and feasibility of using intranasal naloxone were high, and no serious adverse events were reported. Preliminary results suggest mixed results in terms of gambling behaviour (ie, reduced frequency but not expenditure) and decreased depressive symptoms.
TRIAL REGISTRATION NUMBER


EudraCT2016-001828-56.",2019,The postintervention SOGS scores were lower (median=4 (IQR=3.75) versus preintervention scores (median=12 (IQR=4.75)).,"['A single study site in the capital region of Finland', 'Problem gambling: South Oaks Gambling Screen (SOGS), depressive symptoms', 'Twenty problem gamblers (nine men', 'gambling disorder (GD']","['naloxone', 'Naloxone hydrochloride nasal spray', 'nostril (4\u2009mg naloxone', 'intranasal naloxone', 'intranasal naloxone spray']","['postintervention SOGS scores', 'Depressive symptoms', 'serious adverse events', 'depressive symptoms', 'adverse events, gambling frequency and gambling expenditure', 'acceptability and feasibility', 'Acceptability and feasibility scores', 'Beck Depression Inventory (BDI', 'gambling behaviour']","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0030662', 'cui_str': 'Gambling, Pathologic'}]","[{'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0700549', 'cui_str': 'Naloxone Hydrochloride'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0595944', 'cui_str': 'Structure of anterior naris'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}]",20.0,0.0566064,The postintervention SOGS scores were lower (median=4 (IQR=3.75) versus preintervention scores (median=12 (IQR=4.75)).,"[{'ForeName': 'Sari', 'Initials': 'S', 'LastName': 'Castrén', 'Affiliation': 'Department of Public Health Solutions, Terveyden ja hyvinvoinnin laitos, Helsinki, Finland.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Mäkelä', 'Affiliation': 'Alcohol, Drugs and Addictions Unit, Terveyden ja hyvinvoinnin laitos, Helsinki, Finland.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Haikola', 'Affiliation': 'Faculty of Natural Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Salonen', 'Affiliation': 'Alcohol, Drugs and Addictions Unit, Terveyden ja hyvinvoinnin laitos, Helsinki, Finland.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Crystal', 'Affiliation': 'Opiant Pharmaceuticals, Santa Monica, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Scheinin', 'Affiliation': 'Institute of Biomedicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Alho', 'Affiliation': 'Alcohol, Drugs and Addictions Unit, Terveyden ja hyvinvoinnin laitos, Helsinki, Finland.'}]",BMJ open,['10.1136/bmjopen-2018-023728']
560,32150255,"Measuring Opioid Withdrawal in a Phase 3 Study of a New Analgesic, NKTR-181 (Oxycodegol), in Patients with Moderate to Severe Chronic Low Back Pain.","OBJECTIVE


To evaluate the SUMMIT-07 trial opioid withdrawal results of NKTR-181 (oxycodegol), a new molecular entity mu-opioid receptor agonist.
DESIGN


Phase 3, enriched-enrollment, double-blind, randomized-withdrawal study in patients with chronic low back pain (CLBP).
SETTING


Conducted in the United States at multiple sites.
METHODS


SUMMIT-07 was comprised of five periods: screening; NKTR-181 open-label titration (100 to 400 mg twice daily); 12-week randomized, double-blind study drug (NKTR-181 or placebo); one-week study drug taper; and two-week safety follow-up. Permitted rescue medication included hydrocodone 5 mg/acetaminophen 300 mg (two tablets daily) for two weeks after randomization, then acetaminophen 1.0 gm daily for the remainder of the trial. Signs and symptoms of drug withdrawal were evaluated using the Clinical Opiate Withdrawal Scale (COWS); Subjective Opiate Withdrawal Scale (SOWS); Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS); and withdrawal-related adverse events.
RESULTS


Of 1,190 patients entering titration, one patient had moderate withdrawal (COWS score 13/48 maximum) three days after discontinuing NKTR-181. Of 610 patients randomized (N = 309, NKTR-181; N = 301, placebo), no COWS scores indicating withdrawal at a moderate level or greater (i.e., score ≥13) were observed at any time point. At day 8 after randomization, week 12, and the end of tapering, COWS scores indicating mild withdrawal (<13) were observed in seven (2.4%), one (0.4%), and one (0.5%) placebo patients, respectively, and three (1.0%), one (0.4%), and five (2.3%) NKTR-181 patients, respectively. Mean SOWS scores in both arms were ≤2.8 of 64 possible points at all time points. During the randomized period, of 35 events identified by MADDERS, adjudicators identified 20 possible ""withdrawal"" events (9 [2.9%] NKTR-181 and 11 [3.7%] placebo).
CONCLUSIONS


NKTR-181 exhibited a low rate and severity of opioid withdrawal in SUMMIT-07 patients with CLBP.",2020,", one patient had moderate withdrawal (COWS score 13/48 maximum) three days after discontinuing NKTR-181.","['Patients with Moderate to Severe Chronic Low Back Pain', 'SUMMIT-07 was comprised of five periods: screening', 'patients with chronic low back pain (CLBP', '1,190 patients entering titration', 'Conducted in the United States at multiple sites', 'SUMMIT-07 patients with CLBP']","['NKTR-181 (oxycodegol', 'placebo', 'hydrocodone 5', 'NKTR-181 open-label titration', 'acetaminophen', 'double-blind study drug (NKTR-181 or placebo']","['Clinical Opiate Withdrawal Scale (COWS); Subjective Opiate Withdrawal Scale (SOWS); Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS); and withdrawal-related adverse events', 'Mean SOWS scores', 'Signs and symptoms of drug withdrawal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C4547855', 'cui_str': 'NKTR-181'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0020264', 'cui_str': 'Hydrocodone'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0013072', 'cui_str': 'Double-Masked Method'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C3472219', 'cui_str': 'Clinical opiate withdrawal scale (assessment scale)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0222045'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0185033', 'cui_str': 'Diversion'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]",1190.0,0.376243,", one patient had moderate withdrawal (COWS score 13/48 maximum) three days after discontinuing NKTR-181.","[{'ForeName': 'Jack E', 'Initials': 'JE', 'LastName': 'Henningfield', 'Affiliation': 'Pinney Associates, Bethesda, Maryland.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gudin', 'Affiliation': 'Englewood Hospital and Medical Center, Englewood, New Jersey.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rauck', 'Affiliation': 'Carolinas Pain Institute and The Center for Clinical Research, Winston-Salem, North Carolina.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Gimbel', 'Affiliation': 'Arizona Research Center, Phoenix, Arizona.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Tagliaferri', 'Affiliation': 'Nektar Therapeutics, San Francisco, California.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Doberstein', 'Affiliation': 'Nektar Therapeutics, San Francisco, California.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Fonzo', 'Affiliation': 'Nektar Therapeutics, San Francisco, California.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Nektar Therapeutics, San Francisco, California.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Katz', 'Affiliation': 'Tufts University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Siddhanti', 'Affiliation': 'Nektar Therapeutics, San Francisco, California.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Schnoll', 'Affiliation': 'Pinney Associates, Bethesda, Maryland.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz326']
561,32145830,"Nintedanib in patients with progressive fibrosing interstitial lung diseases-subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial.","BACKGROUND


The INBUILD trial investigated the efficacy and safety of nintedanib versus placebo in patients with progressive fibrosing interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis (IPF). We aimed to establish the effects of nintedanib in subgroups based on ILD diagnosis.
METHODS


The INBUILD trial was a randomised, double-blind, placebo-controlled, parallel group trial done at 153 sites in 15 countries. Participants had an investigator-diagnosed fibrosing ILD other than IPF, with chest imaging features of fibrosis of more than 10% extent on high resolution CT (HRCT), forced vital capacity (FVC) of 45% or more predicted, and diffusing capacity of the lung for carbon monoxide (DLco) of at least 30% and less than 80% predicted. Participants fulfilled protocol-defined criteria for ILD progression in the 24 months before screening, despite management considered appropriate in clinical practice for the individual ILD. Participants were randomly assigned 1:1 by means of a pseudo-random number generator to receive nintedanib 150 mg twice daily or placebo for at least 52 weeks. Participants, investigators, and other personnel involved in the trial and analysis were masked to treatment assignment until after database lock. In this subgroup analysis, we assessed the rate of decline in FVC (mL/year) over 52 weeks in patients who received at least one dose of nintedanib or placebo in five prespecified subgroups based on the ILD diagnoses documented by the investigators: hypersensitivity pneumonitis, autoimmune ILDs, idiopathic non-specific interstitial pneumonia, unclassifiable idiopathic interstitial pneumonia, and other ILDs. The trial has been completed and is registered with ClinicalTrials.gov, number NCT02999178.
FINDINGS


Participants were recruited between Feb 23, 2017, and April 27, 2018. Of 663 participants who received at least one dose of nintedanib or placebo, 173 (26%) had chronic hypersensitivity pneumonitis, 170 (26%) an autoimmune ILD, 125 (19%) idiopathic non-specific interstitial pneumonia, 114 (17%) unclassifiable idiopathic interstitial pneumonia, and 81 (12%) other ILDs. The effect of nintedanib versus placebo on reducing the rate of FVC decline (mL/year) was consistent across the five subgroups by ILD diagnosis in the overall population (hypersensitivity pneumonitis 73·1 [95% CI -8·6 to 154·8]; autoimmune ILDs 104·0 [21·1 to 186·9]; idiopathic non-specific interstitial pneumonia 141·6 [46·0 to 237·2]; unclassifiable idiopathic interstitial pneumonia 68·3 [-31·4 to 168·1]; and other ILDs 197·1 [77·6 to 316·7]; p=0·41 for treatment by subgroup by time interaction). Adverse events reported in the subgroups were consistent with those reported in the overall population.
INTERPRETATION


The INBUILD trial was not designed or powered to provide evidence for a benefit of nintedanib in specific diagnostic subgroups. However, its results suggest that nintedanib reduces the rate of ILD progression, as measured by FVC decline, in patients who have a chronic fibrosing ILD and progressive phenotype, irrespective of the underlying ILD diagnosis.
FUNDING


Boehringer Ingelheim.",2020,"Participants fulfilled protocol-defined criteria for ILD progression in the 24 months before screening, despite management considered appropriate in clinical practice for the individual ILD.","['patients with progressive fibrosing interstitial lung diseases-subgroup analyses by interstitial lung disease diagnosis', 'Participants were recruited between Feb 23, 2017, and April 27, 2018', ' 125 (19%) idiopathic non-specific interstitial pneumonia, 114 (17%) unclassifiable idiopathic interstitial pneumonia, and 81 (12%) other ILDs', '153 sites in 15 countries', '663 participants who received at least one dose of', 'patients with progressive fibrosing interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis (IPF']","['nintedanib or placebo', 'Nintedanib', 'nintedanib 150 mg twice daily or placebo', 'placebo', 'nintedanib versus placebo']","['Adverse events', 'rate of decline in FVC', 'rate of FVC decline', 'rate of ILD progression', 'high resolution CT (HRCT), forced vital capacity (FVC', 'chronic hypersensitivity pneumonitis', 'autoimmune ILD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0206061', 'cui_str': 'Pneumonitis, Interstitial'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3859350', 'cui_str': 'nintedanib 150 MG [Ofev]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0002390', 'cui_str': 'Pneumonitis, Hypersensitivity'}]",,0.727131,"Participants fulfilled protocol-defined criteria for ILD progression in the 24 months before screening, despite management considered appropriate in clinical practice for the individual ILD.","[{'ForeName': 'Athol U', 'Initials': 'AU', 'LastName': 'Wells', 'Affiliation': 'National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, London, UK.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Flaherty', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai City, Osaka, Japan.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Devaraj', 'Affiliation': 'Department of Radiology, Royal Brompton and Harefield NHS Foundation Trust, London, UK; National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Richeldi', 'Affiliation': 'Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Teng', 'Initials': 'T', 'LastName': 'Moua', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Mayo Clinic Rochester, Rochester, MN, USA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Crestani', 'Affiliation': 'Université de Paris, Inserm U1152, APHP, Hôpital Bichat, Centre de reference constitutif pour les maladies pulmonaires rares, Paris, France.'}, {'ForeName': 'Wim A', 'Initials': 'WA', 'LastName': 'Wuyts', 'Affiliation': 'Unit for Interstitial Lung Diseases, Department of Pulmonary Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Stowasser', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Quaresma', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Rainer-Georg', 'Initials': 'RG', 'LastName': 'Goeldner', 'Affiliation': 'Boehringer Ingelheim Pharma, Biberach, Germany.'}, {'ForeName': 'Rozsa', 'Initials': 'R', 'LastName': 'Schlenker-Herceg', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kolb', 'Affiliation': ""McMaster University and St Joseph's Healthcare, Hamilton, Ontario, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30036-9']
562,31075393,Delta-9-tetrahydrocannabinol intoxication is associated with increased prefrontal activation as assessed with functional near-infrared spectroscopy: A report of a potential biomarker of intoxication.,"The primary psychoactive compound in cannabis, Δ9-tetrahydrocannabinol (THC), binds to cannabinoid receptors (CB1) present in high concentrations in the prefrontal cortex (PFC). It is unknown whether the PFC hemodynamic response changes with THC intoxication. We conducted the first double-blind, placebo-controlled, cross-over study of the effect of THC intoxication on functional near infrared spectroscopy (fNIRS) measures of PFC activation. Fifty-four adult, regular (at least weekly) cannabis users received a single oral dose of synthetic THC (dronabinol; 5-50 mg, dose individually tailored to produce intoxication) and identical placebo on two visits at least one week apart. fNIRS recordings were obtained during a working memory task (N-Back) at three timepoints: before THC/placebo, at 100 min (when peak effects were expected), and at 200 min after THC/placebo administration. Functional data were collected using a continuous-wave NIRS device, with 8 sources and 7 detectors arrayed over the forehead, resulting in 20 channels covering PFC regions. Participants also completed frequent heart rate measures and subjective ratings of intoxication. Approximately half of participants reported significant intoxication. Intoxication ratings were not correlated with dose of THC. Increases in heart rate significantly correlated with intoxication ratings after THC dosing. Results indicated that 100 min after THC administration, oxygenated hemoglobin (HbO) response significantly increased from pre-dose HbO levels throughout the PFC in participants who reported significant intoxication. Changes in HbO response significantly correlated with self-reported intoxication at 100 min after THC administration. Among those who reported intoxication, HbO response decreased at 200 min after THC, when intoxication had largely resolved, compared to the peak THC time point. This study demonstrates that THC intoxication causes increased PFC activity, and fNIRS of the PFC can measure this effect. Increased neural activation in PFC represents a potential biomarker for cannabis intoxication.",2019,"Among those who reported intoxication, HbO response decreased at 200 min after THC, when intoxication had largely resolved, compared to the peak THC time point.",['Fifty-four adult'],"['synthetic THC (dronabinol; 5-50\u202fmg, dose individually tailored to produce intoxication) and identical placebo', 'THC intoxication', 'placebo', 'THC/placebo']","['heart rate', 'oxygenated hemoglobin (HbO) response', 'PFC activity', 'heart rate measures and subjective ratings of intoxication', 'HbO response', 'neural activation', 'Intoxication ratings', 'Changes in HbO response']","[{'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.208163,"Among those who reported intoxication, HbO response decreased at 200 min after THC, when intoxication had largely resolved, compared to the peak THC time point.","[{'ForeName': 'Jodi M', 'Initials': 'JM', 'LastName': 'Gilman', 'Affiliation': 'Massachusetts General Hospital (MGH) Department of Psychiatry, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; MGH/HST Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA. Electronic address: jgilman1@mgh.harvard.edu.'}, {'ForeName': 'Meryem A', 'Initials': 'MA', 'LastName': 'Yücel', 'Affiliation': 'MGH/HST Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, USA; Neurophotonics Center, Department of Biomedical Engineering, Boston University, Boston, MA, USA.'}, {'ForeName': 'Gladys N', 'Initials': 'GN', 'LastName': 'Pachas', 'Affiliation': 'Massachusetts General Hospital (MGH) Department of Psychiatry, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Potter', 'Affiliation': 'Massachusetts General Hospital (MGH) Department of Psychiatry, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Levar', 'Affiliation': 'Massachusetts General Hospital (MGH) Department of Psychiatry, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Broos', 'Affiliation': 'Massachusetts General Hospital (MGH) Department of Psychiatry, Boston, MA, USA.'}, {'ForeName': 'Eve M', 'Initials': 'EM', 'LastName': 'Manghis', 'Affiliation': 'Massachusetts General Hospital (MGH) Department of Psychiatry, Boston, MA, USA.'}, {'ForeName': 'Randi M', 'Initials': 'RM', 'LastName': 'Schuster', 'Affiliation': 'Massachusetts General Hospital (MGH) Department of Psychiatry, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'A Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Massachusetts General Hospital (MGH) Department of Psychiatry, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.'}]",NeuroImage,['10.1016/j.neuroimage.2019.05.012']
563,30433852,Bladder Preservation With Twice-a-Day Radiation Plus Fluorouracil/Cisplatin or Once Daily Radiation Plus Gemcitabine for Muscle-Invasive Bladder Cancer: NRG/RTOG 0712-A Randomized Phase II Trial.,"PURPOSE


Fluorouracil plus cisplatin and radiation twice a day (FCT) is an established chemoradiation (CRT) regimen for selective bladder-sparing treatment of muscle-invasive bladder cancer. Gemcitabine and once daily radiation (GD) is a well-supported alternative. The current trial evaluates these regimens.
METHODS


Patients with cT2-4a muscle-invasive bladder cancer were randomly assigned to FCT or GD. Patients underwent transurethral resection and induction CRT to 40 Gy. Patients who achieved a complete response (CR) received consolidation CRT to 64 Gy and others underwent cystectomy. We administered adjuvant gemcitabine/cisplatin chemotherapy. The primary end point was the rate of freedom from distant metastasis at 3 years (DMF3). The trial was not statistically powered to compare regimens, but to assess whether either regimen exceeded a DMF3 benchmark of 75%. Toxicity and efficacy end points, including CR and bladder-intact distant metastasis free survival at 3 years (BI-DMFS3), were assessed.
RESULTS


From December 2008 to April 2014, 70 patients were enrolled, of which 66 were eligible for analysis, 33 per arm. Median follow-up was 5.1 years (range, 0.4 to 7.8 years) for eligible living patients. DMF3 was 78% and 84% for FCT and GD, respectively. BI-DMFS3 was 67% and 72%, respectively. Postinduction CR rates were 88% and 78%, respectively. Of 33 patients in the FCT arm, 21 (64%) experienced treatment-related grade 3 and 4 toxicities during protocol treatment, with 18 (55%), two (6%), and two patients (6%) experiencing grade 3 and 4 hematologic, GI, and genitourinary toxicity, respectively. For the 33 patients in the GD arm, these figures were 18 (55%) overall and 14 (42%), three (9%) and two patients (6%), respectively.
CONCLUSION


Both regimens demonstrated DMF3 greater than 75%. There were fewer toxicities observed in the GD arm. Either gemcitabine and once daily radiation or a cisplatin-based regimen could serve as a base for future trials of systemic therapy.",2019,"Of 33 patients in the FCT arm, 21 (64%) experienced treatment-related grade 3 and 4 toxicities during protocol treatment, with 18 (55%), two (6%), and two patients (6%) experiencing grade 3 and 4 hematologic, GI, and genitourinary toxicity, respectively.","['Muscle-Invasive Bladder Cancer', 'Patients who achieved a complete response (CR) received', '70 patients were enrolled, of which 66 were eligible for analysis, 33 per arm', 'From December 2008 to April 2014', 'Patients with cT2-4a muscle-invasive bladder cancer', 'muscle-invasive bladder cancer']","['adjuvant gemcitabine/cisplatin chemotherapy', 'FCT', 'transurethral resection and induction CRT', 'Gemcitabine and once daily radiation (GD', 'gemcitabine and once daily radiation or a cisplatin-based regimen', 'FCT or GD', 'Fluorouracil plus cisplatin and radiation twice a day (FCT', 'Bladder Preservation With Twice-a-Day Radiation Plus Fluorouracil/Cisplatin or Once Daily Radiation Plus Gemcitabine', 'consolidation CRT']","['Postinduction CR rates', 'DMF3', 'rate of freedom from distant metastasis at 3 years (DMF3', 'toxicities', 'treatment-related grade 3 and 4 toxicities', 'experiencing grade 3 and 4 hematologic, GI, and genitourinary toxicity', 'Toxicity and efficacy end points, including CR and bladder-intact distant metastasis free survival']","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}]","[{'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",70.0,0.0660889,"Of 33 patients in the FCT arm, 21 (64%) experienced treatment-related grade 3 and 4 toxicities during protocol treatment, with 18 (55%), two (6%), and two patients (6%) experiencing grade 3 and 4 hematologic, GI, and genitourinary toxicity, respectively.","[{'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Coen', 'Affiliation': '1 21st Century Oncology, Providence, RI.'}, {'ForeName': 'Peixin', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': '2 NRG Oncology, Philadelphia, PA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Saylor', 'Affiliation': '3 Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Cheryl T', 'Initials': 'CT', 'LastName': 'Lee', 'Affiliation': '4 Ohio State University, Columbus, OH.'}, {'ForeName': 'Chin-Lee', 'Initials': 'CL', 'LastName': 'Wu', 'Affiliation': '3 Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Parker', 'Affiliation': '5 McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Lautenschlaeger', 'Affiliation': '6 Indiana University Cancer Center, Indianapolis, IN.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Zietman', 'Affiliation': '3 Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Efstathiou', 'Affiliation': '3 Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Ashesh B', 'Initials': 'AB', 'LastName': 'Jani', 'Affiliation': '7 Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Kucuk', 'Affiliation': '7 Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Souhami', 'Affiliation': '5 McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Rodgers', 'Affiliation': '2 NRG Oncology, Philadelphia, PA.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Sandler', 'Affiliation': '7 Cedars-Sinai Medical Center, Los Angeles, CA.'}, {'ForeName': 'William U', 'Initials': 'WU', 'LastName': 'Shipley', 'Affiliation': '3 Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.00537']
564,30283029,"Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD).","Numerous placebo-controlled studies have demonstrated the ability of ketamine, an NMDA receptor antagonist, to induce rapid (within hours), transient antidepressant effects when administered intravenously (IV) at subanesthetic doses (0.5 mg/kg over 40 min). However, the optimal antidepressant dose remains unknown. We aimed to compare to active placebo the rapid acting antidepressant properties of a broad range of subanesthetic doses of IV ketamine among outpatients with treatment-resistant depression (TRD). A range of IV ketamine doses were compared to active placebo in the treatment of adult TRD over a 3-day period following a single infusion over 40 min. This was an outpatient study conducted across six US academic sites. Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode. Following a washout period, 99 eligible subjects were randomly assigned to one of the five arms in a 1:1:1:1:1 fashion: a single intravenous dose of ketamine 0.1 mg/kg (n = 18), a single dose of ketamine 0.2 mg/kg (n = 20), a single dose of ketamine 0.5 mg/kg (n = 22), a single dose of ketamine 1.0 mg/kg (n = 20), and a single dose of midazolam 0.045 mg/kg (active placebo) (n = 19). The study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I) were performed at days 0, 1, 3 (endpoint), 5, 7, 14, and 30 to assess the safety and efficacy. The overall group × time interaction effect was significant for the primary outcome measure, the HAM-D-6. In post hoc pairwise comparisons controlling for multiple comparisons, standard dose (0.5 mg/kg) and high dose (1 mg/kg) of intravenous ketamine were superior to active placebo; a low dose (0.1 mg/kg) was significant only prior to adjustment (p = 0.02, p-adj = 0.14, d = -0.82 at day 1). Most of the interaction effect was due to differences at day 1, with no significant adjusted pairwise differences at day 3. This pattern generally held for secondary outcomes. The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses. Our results suggest that there is evidence for the efficacy of the 0.5 mg/kg and 1.0 mg/kg subanesthetic doses of IV ketamine and no clear or consistent evidence for clinically meaningful efficacy of lower doses of IV ketamine. Trial Registration: NCT01920555.",2020,"The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.","['99 eligible subjects', 'Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode', 'treatment-resistant depression (TRD', 'outpatients with treatment-resistant depression (TRD']","['ketamine', 'IV ketamine', 'placebo', 'midazolam 0.045\u2009mg/kg (active placebo', 'ketamine 0.1\u2009mg/kg']","['safety and efficacy', 'HAM-D-6', 'dissociative symptoms and transient blood pressure elevations', 'study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4517410', 'cui_str': 'Zero point zero four five'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",99.0,0.456136,"The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.","[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA. mfava@mgh.harvard.edu.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Judge', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Bettina B', 'Initials': 'BB', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Lee C', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Debattista', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Schatzberg', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Wilkinson', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0256-5']
565,30360984,"A double-blind placebo controlled trial into the impacts of HMB supplementation and exercise on free-living muscle protein synthesis, muscle mass and function, in older adults.","Age-related sarcopenia and dynapenia are associated with frailty and metabolic diseases. Resistance exercise training (RET) adjuvant to evidence-based nutritional intervention(s) have been shown as mitigating strategies. Given that β-hydroxy-β-methyl-butyrate (HMB) supplementation during RET improves lean body mass in younger humans, and that we have shown that HMB acutely stimulates muscle protein synthesis (MPS) and inhibits breakdown; we hypothesized that chronic supplementation of HMB free acid (HMB-FA) would enhance MPS and muscle mass/function in response to RET in older people. We recruited 16 healthy older men (Placebo (PLA): 68.5 ± 1.0 y, HMB-FA: 67.8 ± 1.15 y) for a randomised double-blind-placebo controlled trial (HMB-FA 3 × 1 g/day vs. PLA) involving a 6-week unilateral progressive RET regime (6 × 8 repetitions, 75% 1-RM, 3 · wk -1 ). Deuterium oxide (D 2 O) dosing was performed over the first two weeks (0-2 wk) and last two weeks (4-6 wk) with bilateral vastus lateralis (VL) biopsies at 0-2 and 4-6 wk (each time 75 ± 2 min after a single bout of resistance exercise (RE)) for quantification of early and later MPS responses and post-RE myogenic gene expression. Thigh lean mass (TLM) was measured by DXA, VL thickness and architecture (fibre length and pennation angle) by ultrasound at 0/3/6 wk, and strength by knee extensor 1-RM testing and MVC by isokinetic dynamometry (approx. every 10 days). RET induced strength increases (1-RM) in the exercised leg of both groups (398 ± 22N to 499 ± 30N HMB-FA vs. 396 ± 29N to 510 ± 43N PLA (both P < 0.05)). In addition, maximal voluntary contraction (MVC) also increased (179 ± 12 Nm to 203 ± 12 Nm HMB-FA vs. 185 ± 10 Nm to 217 ± 11 Nm PLA (both P < 0.05); with no group differences. VL muscle thickness increased significantly in the exercised leg in both groups, with no group differences. TLM (by DXA) rose to significance only in the HMB-FA group (by 5.8%-5734 ± 245 g p = 0.015 vs. 3.0% to 5644 ± 323 g P = 0.06 in PLA). MPS remained unchanged in the untrained legs (UT) 0-2 weeks being 1.06 ± 0.08%.d -1  (HMB-FA) and 1.14 ± 0.09%.d -1  (PLA), the trained legs (T) exhibited increased MPS in the HMB-FA group only at 0-2-weeks (1.39 ± 0.10%.d -1 , P < 0.05) compared with UT: but was not different at 4-6-weeks: 1.26 ± 0.05%.d -1 . However, there were no significant differences in MPS between the HMB-FA and PLA groups at any given time point and no significant treatment interaction observed. We also observed significant inductions of c-Myc gene expression following each acute RE bout, with no group differences. Further, there were no changes in any other muscle atrophy/hypertrophy or myogenic transcription factor genes we measured. RET with adjuvant HMB-FA supplements in free-living healthy older men did not enhance muscle strength or mass greater than that of RET alone (PLA). That said, only HMB-FA increased TLM, supported by early increases in chronic MPS. As such, chronic HMB-FA supplementation may result in long term benefits in older males, however longer and larger studies may be needed to fully determine the potential effects of HMB-FA supplementation; translating to any functional benefit.",2019,RET with adjuvant HMB-FA supplements in free-living healthy older men did not enhance muscle strength or mass greater than that of RET alone (PLA).,"['16 healthy older men (Placebo (PLA): 68.5\xa0±\xa01.0\xa0y, HMB-FA: 67.8\xa0±', 'Nm to 203\xa0±\xa012', '10', 'free-living healthy older men', 'older males', 'older adults', 'younger humans', '245', 'Nm to 217\xa0±']","['Resistance exercise training (RET) adjuvant to evidence-based nutritional intervention(s', 'placebo', 'HMB supplementation and exercise', 'UT', 'bilateral vastus lateralis (VL', 'TLM', 'β-hydroxy-β-methyl-butyrate (HMB) supplementation', 'Deuterium oxide (D 2 O', 'RET with adjuvant HMB-FA supplements']","['Thigh lean mass (TLM', 'MPS', 'muscle atrophy/hypertrophy or myogenic transcription factor genes', 'chronic MPS', 'RET induced strength increases (1-RM', 'VL muscle thickness', 'lean body mass', 'maximal voluntary contraction (MVC']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C4517646', 'cui_str': '217'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0066231', 'cui_str': 'methyl butyrate'}, {'cui': 'C0011745', 'cui_str': 'Heavy Water'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}]","[{'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0026846', 'cui_str': 'Atrophy, Muscle'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0040648'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}]",16.0,0.0731942,RET with adjuvant HMB-FA supplements in free-living healthy older men did not enhance muscle strength or mass greater than that of RET alone (PLA).,"[{'ForeName': 'U S U', 'Initials': 'USU', 'LastName': 'Din', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Brook', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK; Nottingham NIHR BRC, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Selby', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Quinlan', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Boereboom', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Abdulla', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Franchi', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Narici', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'B E', 'Initials': 'BE', 'LastName': 'Phillips', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK; Nottingham NIHR BRC, UK.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Williams', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Rathmacher', 'Affiliation': 'Metabolic Technologies, Inc, Iowa State University Research Park, 2711 S. Loop Drive, Ste 4400, Ames, IA, 50010, USA.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Wilkinson', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK; Nottingham NIHR BRC, UK.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK; Nottingham NIHR BRC, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, Clinical, Metabolic and Molecular Physiology, University of Nottingham, Royal Derby Hospital Centre, Derby, UK; Nottingham NIHR BRC, UK. Electronic address: ken.smith@nottingham.ac.uk.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.09.025']
566,30415648,Bias-contingent attention bias modification and attention control training in treatment of PTSD: a randomized control trial.,"BACKGROUND


Randomized control trials (RCTs) comparing attention control training (ACT) and attention bias modification (ABM) in posttraumatic stress disorder (PTSD) have shown mixed results. The current RCT extends the extant literature by comparing the efficacy of ACT and a novel bias-contingent-ABM (BC-ABM), in which direction of training is contingent upon the direction of pre-treatment attention bias (AB), in a sample of civilian patients with PTSD.
METHODS


Fifty treatment-seeking civilian patients with PTSD were randomly assigned to either ACT or BC-ABM. Clinician and self-report measures of PTSD and depression, as well as AB and attention bias variability (ABV), were acquired pre- and post-treatment.
RESULTS


ACT yielded greater reductions in PTSD and depressive symptoms on both clinician-rated and self-reported measures compared with BC-ABM. The BC-ABM condition successfully shifted ABs in the intended training direction. In the ACT group, there was no significant change in ABV or AB from pre- to post-treatment.
CONCLUSIONS


The current RCT extends previous results in being the first to apply ABM that is contingent upon AB at pre-treatment. This personalized BC-ABM approach is associated with significant reductions in symptoms. However, ACT produces even greater reductions, thereby emerging as a promising treatment for PTSD.",2019,"RESULTS


ACT yielded greater reductions in PTSD and depressive symptoms on both clinician-rated and self-reported measures compared with BC-ABM.","['Fifty treatment-seeking civilian patients with PTSD', 'posttraumatic stress disorder (PTSD', 'PTSD']","['attention control training (ACT) and attention bias modification (ABM', 'ACT or BC-ABM', 'ACT', 'Bias-contingent attention bias modification and attention control training']","['AB and attention bias variability (ABV', 'ABV or AB', 'PTSD and depressive symptoms']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",50.0,0.041961,"RESULTS


ACT yielded greater reductions in PTSD and depressive symptoms on both clinician-rated and self-reported measures compared with BC-ABM.","[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Lazarov', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center and New York State Psychiatric Institute, New York, NY, USA, and School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Suarez-Jimenez', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center and New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Rany', 'Initials': 'R', 'LastName': 'Abend', 'Affiliation': 'Section on Developmental Affective Neuroscience, National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Reut', 'Initials': 'R', 'LastName': 'Naim', 'Affiliation': 'School of Psychological Sciences, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Erel', 'Initials': 'E', 'LastName': 'Shvil', 'Affiliation': 'New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Liat', 'Initials': 'L', 'LastName': 'Helpman', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center and New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center and New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Papini', 'Affiliation': 'Department of Psychology, The University of Texas at Austin, Institute for Mental Health Research, TX, USA.'}, {'ForeName': 'Ariel', 'Initials': 'A', 'LastName': 'Duroski', 'Affiliation': 'New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Rony', 'Initials': 'R', 'LastName': 'Rom', 'Affiliation': 'New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Franklin R', 'Initials': 'FR', 'LastName': 'Schneier', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center and New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Pine', 'Affiliation': 'Section on Developmental Affective Neuroscience, National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Bar-Haim', 'Affiliation': 'School of Psychological Sciences and Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Neria', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center and New York State Psychiatric Institute, New York, NY, USA.'}]",Psychological medicine,['10.1017/S0033291718003367']
567,30361322,Allen Carr's Easyway to Stop Smoking - A randomised clinical trial.,"OBJECTIVE


To determine if Allen Carr's Easyway to Stop Smoking (AC) was superior to Quit.ie in a randomised clinical trial (RCT).
SETTING


Single centre, open RCT, general population based.
PARTICIPANTS


300 adult smokers, 18 years plus, minimum 5 cigarettes daily, and English speaking. AC, 151 (females 44.4%) and Quit.ie, 149 (females 45.6%), mean age 44 years. outcomes for all 300 were analysed (intention-to-treat). Recruited through advertisement from July 2015 to February 2016.
INTERVENTION


Randomly assigned to AC (n=151) and Quit.ie (n=149), matched for age, sex and education. Block randomisation, enrolment and follow-up at 1, 3, 6 and 12 months. Primary aim was to determine if AC had higher quit rates than Quit.ie service at 3 months. Secondary aims: quit rates at 1, 6 and 12 months and analysis of associated factors including weight. AC consisted of a 5-hour seminar, in a group setting. Quit.ie is an online portal for smoking cessation.
RESULTS


AC had higher quit rates at 1, 3, 6 and 12 months. AC: 38%, (n=57), 27% (n=40), 23% (n=35), 22% (n=33) vs Quit.ie: 20% (n=30), 15% (n=22), 15% (n=23), 11% (n=17), respectively (all p values <0.05). Logistic regression AC vs Quit.ie, OR 2.26 (95% CI 1.22 to 4.21) p value=0.01. Weight gain 3.8 kg in AC vs 1.8 kg in Quit.ie (p value <0.05).
CONCLUSIONS


All AC quit rates were superior to Quit.ie, outcomes were comparable with established interventions.
TRIAL REGISTRATION NUMBER


ISRCTN12951013. Recruitment July 2015-February 2016.",2019,"Logistic regression AC vs Quit.ie, OR 2.26 (95% CI 1.22 to 4.21) p value=0.01.","['300 adult smokers, 18 years plus, minimum 5 cigarettes daily, and English speaking', 'Single centre, open RCT, general population based', 'Recruited through advertisement from July 2015 to February 2016', 'mean age 44\u2009years']",['AC'],"['All AC quit rates', 'Weight gain', 'quit rates']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",300.0,0.24439,"Logistic regression AC vs Quit.ie, OR 2.26 (95% CI 1.22 to 4.21) p value=0.01.","[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Keogan', 'Affiliation': 'TobaccoFree Research Institute Ireland, Focas Research Institute, DIT, Dublin 8, Dublin, Ireland.'}, {'ForeName': 'Shasha', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'TobaccoFree Research Institute Ireland, Focas Research Institute, DIT, Dublin 8, Dublin, Ireland.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Clancy', 'Affiliation': 'TobaccoFree Research Institute Ireland, Focas Research Institute, DIT, Dublin 8, Dublin, Ireland.'}]",Tobacco control,['10.1136/tobaccocontrol-2018-054243']
568,30385613,Genetic Variants of  VEGFA  and  FLT4  Are Determinants of Survival in Renal Cell Carcinoma Patients Treated with Sorafenib.,"Molecular markers of sorafenib efficacy in patients with metastatic renal cell carcinoma (mRCC) are not available. The purpose of this study was to discover genetic markers of survival in patients with mRCC treated with sorafenib. Germline variants from 56 genes were genotyped in 295 patients with mRCC. Variant-overall survival (OS) associations were tested in multivariate regression models. Mechanistic studies were conducted to validate clinical associations.  VEGFA  rs1885657, ITGAV rs3816375, and WWOX rs8047917 (sorafenib arm), and  FLT4  rs307826 and VEGFA rs3024987 (sorafenib and placebo arms combined) were associated with shorter OS.  FLT4  rs307826 increased VEGFR-3 phosphorylation, membrane trafficking, and receptor activation. VEGFA rs1885657 and rs58159269 increased transcriptional activity of the constructs containing these variants in endothelial and RCC cell lines, and  VEGFA  rs58159269 increased endothelial cell proliferation and tube formation.  FLT4  rs307826 and  VEGFA  rs58159269 led to reduced sorafenib cytotoxicity. Genetic variation in  VEGFA  and  FLT4  could affect survival in sorafenib-treated patients with mRCC. These markers should be examined in additional malignancies treated with sorafenib and in other angiogenesis inhibitors used in mRCC. SIGNIFICANCE: Clinical and mechanistic data identify germline genetic variants in  VEGFA  and  FLT4  as markers of survival in patients with metastatic renal cell carcinoma.",2019,"VEGFA rs1885657 and rs58159269 increased transcriptional activity of the constructs containing these variants in endothelial and RCC cell lines, and  VEGFA  rs58159269 increased endothelial cell proliferation and tube formation.  ","['295 patients with mRCC', 'patients with metastatic renal cell carcinoma (mRCC', 'patients with mRCC treated with', 'Renal Cell Carcinoma Patients Treated with', 'patients with metastatic renal cell carcinoma']","['Sorafenib', 'sorafenib', 'VEGFA rs3024987 (sorafenib and placebo']","['survival', 'endothelial cell proliferation and tube formation', 'transcriptional activity', 'sorafenib cytotoxicity', 'VEGFR-3 phosphorylation, membrane trafficking, and receptor activation', 'Variant-overall survival (OS) associations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0169539', 'cui_str': 'VEGFR-3'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0004083', 'cui_str': 'Association'}]",295.0,0.0469478,"VEGFA rs1885657 and rs58159269 increased transcriptional activity of the constructs containing these variants in endothelial and RCC cell lines, and  VEGFA  rs58159269 increased endothelial cell proliferation and tube formation.  ","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Crona', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, Center for Pharmacogenomics and Individualized Therapy, The University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Skol', 'Affiliation': 'The University of Chicago, Department of Medicine, Chicago, Illinois.'}, {'ForeName': 'Veli-Matti', 'Initials': 'VM', 'LastName': 'Leppänen', 'Affiliation': 'Wihuri Research Institute and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Dylan M', 'Initials': 'DM', 'LastName': 'Glubb', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, Center for Pharmacogenomics and Individualized Therapy, The University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Etheridge', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, Center for Pharmacogenomics and Individualized Therapy, The University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Hilliard', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Peña', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Montville, New Jersey.'}, {'ForeName': 'Yuri K', 'Initials': 'YK', 'LastName': 'Peterson', 'Affiliation': 'Department of Drug Discovery and Biomedical Sciences, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Klauber-DeMore', 'Affiliation': 'Department of Surgery, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Kari K', 'Initials': 'KK', 'LastName': 'Alitalo', 'Affiliation': 'Wihuri Research Institute and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': 'Division of Pharmacotherapy and Experimental Therapeutics, Center for Pharmacogenomics and Individualized Therapy, The University of North Carolina Eshelman School of Pharmacy, Chapel Hill, North Carolina. innocent@unc.edu.'}]",Cancer research,['10.1158/0008-5472.CAN-18-1089']
569,30352748,Effect of vitamin D supplementation on cardiovascular risk in type 2 diabetes.,"BACKGROUND & AIMS


Whether vitamin D affects lipid profile and cardiovascular disease (CVD) risk is controversial. We evaluated the effect of oral daily vitamin D supplementation on lipid profile and CVD risk in patients with well-controlled type 2 diabetes.
METHODS


Secondary analysis in the vitamin D for established type 2 diabetes (DDM2) study, a double-blind, randomized, placebo-controlled clinical trial. 127 patients (mean age 60 years) with stable (HbA1c ≤ 7.5%) diabetes managed with lifestyle only or lifestyle plus metformin were randomized to receive 4000 IU/day of vitamin D 3  (n = 66) or placebo (n = 61) for 48 weeks. Changes in lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides [TG] and TG/HDL ratio), C-reactive protein and CVD risk (calculated according the American College of Cardiology/American Heart Association [ACC/AHA] guidelines) were assessed at week 24 and 48.
RESULTS


The mean [±SEM] plasma 25-hydroxyvitamin D [25(OH)D] level was higher in the vitamin D vs. the placebo group (20.5 ± 1.18 vs. -1.6 ± 1.2 ng/mL respectively; p < 0.001). There was no statistically significant change in lipid profile, C-reactive protein or CVD risk. Among patients who were not on cholesterol medication (n = 32), vitamin D supplementation reduced TG compared to placebo at week 48 (-18.74 ± 8.91 vs. 9.69 ± 8.60 mg/dL respectively; p = 0.032).
CONCLUSION


One year supplementation with vitamin D 3  at 4000 IU/day did not affect lipid profile, C-reactive protein and CVD risk in patients with stable type 2 diabetes not selected for vitamin D deficiency, with the exception of improvement of TG among patients not on cholesterol medication.
REGISTRATION


ClinicalTrials.gov Identifier NCT01736865.",2019,"There was no statistically significant change in lipid profile, C-reactive protein or CVD risk.","['patients with well-controlled type 2 diabetes', 'patients with stable type 2 diabetes', 'type 2 diabetes', '127 patients (mean age 60 years) with stable (HbA1c\xa0≤\xa07.5%) diabetes managed with lifestyle only or lifestyle plus metformin']","['vitamin D', 'vitamin D supplementation', 'placebo', 'oral daily vitamin D supplementation', 'vitamin D 3  (n\xa0=\xa066) or placebo']","['mean [±SEM] plasma 25-hydroxyvitamin D [25(OH)D] level', 'lipid profile and CVD risk', 'lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides [TG] and TG/HDL ratio), C-reactive protein and CVD risk (calculated according the American College of Cardiology/American Heart Association [ACC/AHA] guidelines', 'lipid profile, C-reactive protein and CVD risk', 'lipid profile, C-reactive protein or CVD risk', 'cardiovascular risk', 'lipid profile and cardiovascular disease (CVD) risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0002458', 'cui_str': 'American Heart Association'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]",127.0,0.526007,"There was no statistically significant change in lipid profile, C-reactive protein or CVD risk.","[{'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Angellotti', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, 800 Washington Street, #268, Boston, MA, 02111, USA. Electronic address: eangellotti@tuftsmedicalcenter.org.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""D'Alessio"", 'Affiliation': ""Division of Endocrinology, Diabetes and Metabolism, Duke University, Durham, NC, 27710, USA. Electronic address: david.d'alessio@duke.edu.""}, {'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Dawson-Hughes', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, 800 Washington Street, #268, Boston, MA, 02111, USA; Bone Metabolism Laboratory, Jean Mayer US Department of Agriculture Human Nutrition Research Center on Aging, Tufts University, Boston, MA, 02111, USA. Electronic address: bess.dawson-hughes@tufts.edu.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chu', 'Affiliation': 'University of Kentucky College of Medicine, Lexington, KY, 40506, USA. Electronic address: ych228@uky.edu.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Nelson', 'Affiliation': 'Predictive Analytics and Comparative Effectiveness (PACE) Center, Tufts Medical Center, Boston, MA, 02111, USA. Electronic address: jnelson2@tuftsmedicalcenter.org.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hu', 'Affiliation': 'Cornell University, Ithaca, NY, 14850, USA. Electronic address: peterhu15412@gmail.com.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Cohen', 'Affiliation': 'Division of Endocrinology, Diabetes & Metabolism, University of Cincinnati College of Medicine and Cincinnati VA Medical Center, Cincinnati, OH, 45267-0547, USA. Electronic address: robert.cohen@uc.edu.'}, {'ForeName': 'Anastassios G', 'Initials': 'AG', 'LastName': 'Pittas', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Tufts Medical Center, 800 Washington Street, #268, Boston, MA, 02111, USA. Electronic address: apittas@tuftsmedicalcenter.org.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2018.10.003']
570,30541483,Feasibility of trial procedures for a randomised controlled trial of a community based group exercise intervention for falls prevention for visually impaired older people: the VIOLET study.,"BACKGROUND


Visually impaired older people (VIOP) have a higher risk of falling than their sighted peers, and are likely to avoid physical activity. The aim was to adapt the existing Falls Management Exercise (FaME) programme for VIOP, delivered in the community, and to investigate the feasibility of conducting a definitive randomised controlled trial (RCT) of this adapted intervention.
METHODS


Two-centre randomised mixed methods pilot trial and economic evaluation of the adapted group-based FaME programme for VIOP versus usual care. A one hour exercise programme ran weekly over 12 weeks at the study sites (Newcastle and Glasgow), delivered by third sector (voluntary and community) organisations. Participants were advised to exercise at home for an additional two hours over the week. Those randomised to the usual activities group received no intervention. Outcome measures were completed at baseline, 12 and 24 weeks. The potential primary outcome was the Short Form Falls Efficacy Scale - International (SFES-I). Participants' adherence was assessed by reviewing attendance records and self-reported compliance to the home exercises. Adherence with the course content (fidelity) by instructors was assessed by a researcher. Adverse events were collected in a weekly phone call.
RESULTS


Eighteen participants, drawn from community-living VIOP were screened; 68 met the inclusion criteria; 64 participants were randomised with 33 allocated to the intervention and 31 to the usual activities arm. 94% of participants provided data at the 12 week visit and 92% at 24 weeks. Adherence was high. The intervention was found to be safe with 76% attending nine or more classes. Median time for home exercise was 50 min per week. There was little or no evidence that fear of falling, balance and falls risk, physical activity, emotional, attitudinal or quality of life outcomes differed between trial arms at follow-up.
CONCLUSIONS


The intervention, FaME, was implemented successfully for VIOP and all progression criteria for a main trial were met. The lack of difference between groups on fear of falling was unsurprising given it was a pilot study but there may have been other contributory factors including suboptimal exercise dose and apparent low risk of falls in participants. These issues need addressing for a future trial.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN ID: 16949845 Registered: 21 May 2015.",2018,"METHODS


Two-centre randomised mixed methods pilot trial and economic evaluation of the adapted group-based FaME programme for VIOP versus usual care.","['visually impaired older people', 'Eighteen participants, drawn from community-living VIOP were screened; 68 met the inclusion criteria; 64 participants', 'Visually impaired older people (VIOP']","['adapted group-based FaME programme for VIOP versus usual care', 'existing Falls Management Exercise (FaME) programme', 'usual activities group received no intervention', 'community based group exercise intervention']","['Adverse events', 'fear of falling, balance and falls risk, physical activity, emotional, attitudinal or quality of life outcomes', 'Short Form Falls Efficacy Scale - International (SFES-I', 'Median time for home exercise']","[{'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1276393', 'cui_str': 'Group exercise (regime/therapy)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling (finding)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0222045'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]",64.0,0.133945,"METHODS


Two-centre randomised mixed methods pilot trial and economic evaluation of the adapted group-based FaME programme for VIOP versus usual care.","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Adams', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE7 7XA, UK. nicola.adams@northumbria.ac.uk.'}, {'ForeName': 'Dawn A', 'Initials': 'DA', 'LastName': 'Skelton', 'Affiliation': 'Institute of Applied Health Research, School of Health & Life Sciences, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Howel', 'Affiliation': 'Institute of Health and Society, Baddiley-Clark Building, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Bailey', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE7 7XA, UK.'}, {'ForeName': 'Rosy', 'Initials': 'R', 'LastName': 'Lampitt', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, 1-4 Claremont Terrace, Newcastle upon Tyne, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Fouweather', 'Affiliation': 'Institute of Health and Society, Baddiley-Clark Building, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Gray', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE7 7XA, UK.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Coe', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE7 7XA, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wilkinson', 'Affiliation': 'Newcastle Clinical Trials Unit, Newcastle University, 1-4 Claremont Terrace, Newcastle upon Tyne, UK.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'Gawler', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE7 7XA, UK.'}, {'ForeName': 'Lex D', 'Initials': 'LD', 'LastName': 'de Jong', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Waterman', 'Affiliation': 'Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Deary', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE7 7XA, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Clarke', 'Affiliation': 'Newcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Steve W', 'Initials': 'SW', 'LastName': 'Parry', 'Affiliation': 'Institute for Ageing and Health, Newcastle University, Newcastle upon Tyne, UK.'}]",BMC geriatrics,['10.1186/s12877-018-0998-6']
571,31941553,Preliminary evaluation of the VIsion PERformance (VIPER) simulator.,"BACKGROUND


This study evaluated the VIsion PERformance (VIPER) simulator's ability to assess the functional visual performance in warfighters conducting civilian and military tasks.
METHODS


Thirty service members, aged 25-35 years old with a best corrected distance visual acuity (VA) better than or equal to 20/20 or logarithm of the minimum angle of resolution (logMAR) 0.00, were randomized to locate and identify road signs and mock improvised explosive devices (IEDs) under either daytime conditions or with infrared imagery, with (cc) and without (sc) wearing their habitual correction. Participants also underwent binocular uncorrected (UDVA) and corrected (CDVA) visual assessment, refraction, contrast sensitivity testing and wavefront aberrometry.
RESULTS


The mean age was 28.47 years. The manifest spherical equivalent was - 3.16 ± 1.75 diopters (D), the UDVA in both eyes (OU) was logMAR 0.83 ± 0.47, and the CDVA OU was - 0.11 ± 0.06. For VIPER, the mean difference in the detection distance (DD) for road signs ccDD vs. scDD was 76.7 ± 52.8 m (P < 0.001). The average difference in identification distance (ID) ccID vs. scID was 13.9 ± 6.3 m (P < 0.001). The mean accuracies were 83.5 and 27.9% for cc and sc, respectively (P < 0.001). The regression analysis indicated that a 1.6 m change in the distance accounts for a 1% change in the accuracy (P = 0.002). Without correction, a 4.1 m change accounts for a 1% change in the accuracy (P < 0.001). The average IED ccDD was 29.9 ± 8.2 m, and that for scDD was 13.2 ± 13.6 m (P < 0.001). The average IED ccID was 32.2 ± 6.2 m and that for the scID was 7.4 ± 10.3 m (P < 0.001). The mean IED identification accuracy was 46.7 and 11.4% for cc and sc, respectively (P < 0.001).
CONCLUSIONS


The preliminary results reflect VIPER's ability to assess functional visual performance when detecting and identifying signs and IEDs. Furthermore, VIPER is able to detect performance changes with and without correction.",2020,"The mean accuracies were 83.5 and 27.9% for cc and sc, respectively (P < 0.001).","['Thirty service members, aged 25-35\u2009years old with a best corrected distance visual acuity (VA) better than or equal to 20/20 or logarithm of the minimum angle of resolution (logMAR) 0.00']","['mock improvised explosive devices (IEDs) under either daytime conditions or with infrared imagery, with (cc) and without (sc) wearing their habitual correction', 'VIsion PERformance (VIPER) simulator']","['detection distance (DD) for road signs ccDD vs. scDD', 'average IED ccDD', 'identification distance', 'mean accuracies', 'functional visual performance', 'mean IED identification accuracy', 'binocular uncorrected (UDVA) and corrected (CDVA) visual assessment, refraction, contrast sensitivity testing and wavefront aberrometry', 'average IED ccID']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}]","[{'cui': 'C0562577', 'cui_str': 'Mocking (finding)'}, {'cui': 'C0015330', 'cui_str': 'Explosive material'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}]","[{'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0442650', 'cui_str': 'Road (environment)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0430943', 'cui_str': 'Refraction'}, {'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C1532953', 'cui_str': 'Wave-front analysis'}]",,0.0702417,"The mean accuracies were 83.5 and 27.9% for cc and sc, respectively (P < 0.001).","[{'ForeName': 'Denise S', 'Initials': 'DS', 'LastName': 'Ryan', 'Affiliation': 'Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir Community Hospital, Fort Belvoir, VA, 22060, USA. denise.s.ryan.ctr@mail.mil.'}, {'ForeName': 'Rose K', 'Initials': 'RK', 'LastName': 'Sia', 'Affiliation': 'Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir Community Hospital, Fort Belvoir, VA, 22060, USA.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Eaddy', 'Affiliation': 'Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir Community Hospital, Fort Belvoir, VA, 22060, USA.'}, {'ForeName': 'Lorie A', 'Initials': 'LA', 'LastName': 'Logan', 'Affiliation': 'Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir Community Hospital, Fort Belvoir, VA, 22060, USA.'}, {'ForeName': 'Jide O', 'Initials': 'JO', 'LastName': 'Familoni', 'Affiliation': 'Night Vision and Electronic Sensors Directorate, Fort Belvoir, VA, 22060, USA.'}, {'ForeName': 'Hind', 'Initials': 'H', 'LastName': 'Beydoun', 'Affiliation': 'Department of Research Programs, Fort Belvoir Community Hospital, Fort Belvoir, VA, 22060, USA.'}, {'ForeName': 'Samantha B', 'Initials': 'SB', 'LastName': 'Rodgers', 'Affiliation': 'Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir Community Hospital, Fort Belvoir, VA, 22060, USA.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Rivers', 'Affiliation': 'Warfighter Refractive Eye Surgery Program and Research Center, Fort Belvoir Community Hospital, Fort Belvoir, VA, 22060, USA.'}]",Military Medical Research,['10.1186/s40779-020-0231-8']
572,31980445,Prophylactic hydrocortisone in extremely preterm infants and brain MRI abnormality.,"OBJECTIVE


To determine whether early low-dose hydrocortisone treatment in extremely preterm infants is associated with brain damage assessed by MRI at term equivalent of age (TEA).
PATIENTS AND OUTCOMES


This is a predefined secondary analysis of brain abnormalities, observed by MRI at TEA, of patients randomly assigned to receive either placebo or hydrocortisone in the PREMILOC trial. Outcomes were based on brain abnormalities graded according to Kidokoro scores.
RESULTS


Among 412 survivors at TEA, 300 MRIs were performed and 295 were suitable for analysis. Kidokoro scoring was completed for 119/148 and 110/147 MRIs in the hydrocortisone and placebo groups, respectively. The distribution of the Kidokoro white matter (WM) subscore and other subscores was not significantly different between the two groups. There was, however, a significant association between a higher overall Kidokoro score and hydrocortisone treatment (5.84 (SD 3.51) for hydrocortisone and 4.98 (SD 2.52) for placebo; mean difference, 0.86; 95% CI 0.06 to 1.66; p=0.04). However, hydrocortisone was not statistically associated with moderate-to-severe brain lesions (Kidokoro overall score ≥6) in a multivariate logistic regression model accounting for potential confounding variables (adjusted OR (95% CI) 1.27 (0.75 to 2.14), p=0.38). Bronchopulmonary dysplasia at 36 weeks postmenstrual age significantly predicted both WM damage (adjusted OR (95% CI) 2.70 (1.03 to 7.14), p=0.04) and global brain damage (adjusted OR (95% CI) 2.18 (1.19 to 3.99), p=0.01).
CONCLUSIONS


Early hydrocortisone exposure in extremely preterm infants is not statistically associated with either WM brain damage or overall moderate-to-severe brain lesions when adjusted for other neonatal variables.
TRIAL REGISTRATION NUMBER


EudraCT number 2007-002041-20, NCT00623740.",2020,"CONCLUSIONS


Early hydrocortisone exposure in extremely preterm infants is not statistically associated with either WM brain damage or overall moderate-to-severe brain lesions when adjusted for other neonatal variables.
","['412 survivors at TEA, 300 MRIs were performed and 295 were suitable for analysis', 'extremely preterm infants and brain MRI abnormality', 'extremely preterm infants']","['Prophylactic hydrocortisone', 'placebo or hydrocortisone', 'hydrocortisone and placebo', 'hydrocortisone']","['overall Kidokoro score', 'moderate-to-severe brain lesions', 'distribution of the Kidokoro white matter (WM) subscore and other subscores', 'Kidokoro scoring', 'global brain damage', 'Bronchopulmonary dysplasia', 'WM damage', 'brain abnormalities graded according to Kidokoro scores']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain (finding)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0682708'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0270611', 'cui_str': 'Brain Injuries'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",300.0,0.615394,"CONCLUSIONS


Early hydrocortisone exposure in extremely preterm infants is not statistically associated with either WM brain damage or overall moderate-to-severe brain lesions when adjusted for other neonatal variables.
","[{'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Alison', 'Affiliation': 'Pediatric Radiology, Hôpital Universitaire Robert Debré, Paris, France.'}, {'ForeName': 'Bogdana', 'Initials': 'B', 'LastName': 'Tilea', 'Affiliation': 'Pediatric Radiology, Hôpital Universitaire Robert Debré, Paris, France.'}, {'ForeName': 'Artemis', 'Initials': 'A', 'LastName': 'Toumazi', 'Affiliation': 'Pediatric Radiology, Hôpital Universitaire Robert Debré, Paris, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Biran', 'Affiliation': 'Neonatal Intensive Care Unit, Hopital Universitaire Robert Debre, Paris, Île-de-France, France.'}, {'ForeName': 'Damir', 'Initials': 'D', 'LastName': 'Mohamed', 'Affiliation': ""Centre d'Investigation Clinique-Epidémiologie Clinique, Hopital Universitaire Robert Debre, Paris, France.""}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Alberti', 'Affiliation': ""Centre d'Investigation Clinique-Epidémiologie Clinique, Hopital Universitaire Robert Debre, Paris, France.""}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Bourmaud', 'Affiliation': 'Pediatric Radiology, Hôpital Universitaire Robert Debré, Paris, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Baud', 'Affiliation': 'Inserm U1141, University of Paris, Paris, France olivier.baud@hcuge.ch.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-317720']
573,32143986,Randomized trial of a patient education tool about leiomyoma.,"OBJECTIVE


Uterine leiomyomata are a frequent indication for women seeking gynecologic care [1]. The objective of our study was to assess whether patient knowledge about leiomyomata, anxiety, or satisfaction with counseling differed in patients who received multimedia counseling versus standard counseling.
METHODS


Women with leiomyomata who presented to the gynecology clinic at a single institution were randomized to standard counseling or multimedia counseling using the drawMD OB/GYN iPad™ application. Participants completed a pre-counseling questionnaire, received the designated method of counseling, and completed a post-counseling questionnaire. Outcomes of the study included assessment of patient knowledge, satisfaction, and anxiety.
RESULTS


Seventy-two participants were randomized. There was no significant difference in post-counseling anxiety between the groups (p = 0.86). For both groups, anxiety significantly improved after counseling. Both groups were satisfied with the counseling they received, however, there was no difference between groups. Participants in both groups significantly improved their knowledge about fibroids post-counseling.
CONCLUSION


Counseling of patients with leiomyomata improves patient satisfaction and knowledge. The addition of a multimedia tool may or may not enhance patient counseling.
PRACTICE IMPLICATIONS


This is the first prospective, randomized controlled trial evaluating the impact of a multimedia tool on patient education and counseling for patients with leiomyomata.",2020,There was no significant difference in post-counseling anxiety between the groups (p = 0.86).,"['Women with leiomyomata who presented to the gynecology clinic at a single institution', 'patients with', 'Seventy-two participants were randomized', 'patients with leiomyomata']","['leiomyomata', 'multimedia counseling versus standard counseling', 'patient education tool about leiomyoma', 'standard counseling or multimedia counseling using the drawMD OB/GYN iPad™ application']","['anxiety', 'patient knowledge about leiomyomata, anxiety, or satisfaction with counseling', 'knowledge about fibroids post-counseling', 'patient satisfaction and knowledge', 'patient knowledge, satisfaction, and anxiety', 'post-counseling anxiety']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C3839674', 'cui_str': 'Gynecology clinic'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0042133', 'cui_str': 'Fibroid Uterus'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",72.0,0.111555,There was no significant difference in post-counseling anxiety between the groups (p = 0.86).,"[{'ForeName': 'Prerna R', 'Initials': 'PR', 'LastName': 'Pandya', 'Affiliation': 'Department of Obstetrics and Gynecology, Loyola University Medical Center, 2160 S 1st Avenue, Maywood, IL 60153, USA. Electronic address: prernaraj@gmail.com.'}, {'ForeName': 'Rebecka B', 'Initials': 'RB', 'LastName': 'Docken', 'Affiliation': 'Department of Obstetrics and Gynecology, Loyola University Medical Center, 2160 S 1st Avenue, Maywood, IL 60153, USA.'}, {'ForeName': 'Nicole O', 'Initials': 'NO', 'LastName': 'Sonn', 'Affiliation': 'Department of Obstetrics and Gynecology, Loyola University Medical Center, 2160 S 1st Avenue, Maywood, IL 60153, USA.'}, {'ForeName': 'Dara P', 'Initials': 'DP', 'LastName': 'Matthew', 'Affiliation': 'Department of Obstetrics and Gynecology, Loyola University Medical Center, 2160 S 1st Avenue, Maywood, IL 60153, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Sung', 'Affiliation': 'Department of Obstetrics and Gynecology, Loyola University Medical Center, 2160 S 1st Avenue, Maywood, IL 60153, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Tsambarlis', 'Affiliation': 'Department of Obstetrics and Gynecology, Loyola University Medical Center, 2160 S 1st Avenue, Maywood, IL 60153, USA.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'White', 'Affiliation': 'Department of Obstetrics and Gynecology, Loyola University Medical Center, 2160 S 1st Avenue, Maywood, IL 60153, USA.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Yang', 'Affiliation': 'Department of Obstetrics and Gynecology, Loyola University Medical Center, 2160 S 1st Avenue, Maywood, IL 60153, USA.'}]",Patient education and counseling,['10.1016/j.pec.2020.02.031']
574,32144015,Snodgrass vs Snodgraft operation to repair the distal hypospadias in the narrow urethral plate.,"BACKGROUND


Using the Snodgraft technique in patients with urethral plate less than 8 mm to repair distal hypospadias is still debatable. Some authors assume that augmentation may be beneficial. We aimed to compare the outcomes of the Snodgrass vs Snodgraft procedure in patients with a narrow urethral plate less than 8 mm.
METHODOLOGY


This prospective randomized study included 60 children who had been treated by the Snodgrass or Snodgraft procedure for repair of distal penile hypospadias with narrow urethral plate from March 2017 to September 2018. They were randomized into two subgroups. Group 1 (30 patients) underwent tubularized incised plate urethroplasty, whereas the second group (30 patients) underwent the Snodgraft procedure by using the inner prepuce. Operative details, postoperative period, and complications were reported and statistically analyzed using IBM SPSS software package version 20.0.
RESULTS


The operative time was longer for patients who underwent the Snodgraft procedure: 78 (55-95) and 110 (80-140) minutes in groups 1 and 2, respectively. In group 1, there was one case of meatal stenosis which was resolved by urethral dilation using the local anesthetic cream in the outpatient clinic. In addition, there was another case of distal penile fistula. In group 2, there was a case of complete wound disruption and another of distal penile fistula. There was no significant difference in the complication rate in any group.
CONCLUSION


The operative time was longer in group 2 than in group 1 but with comparable outcomes. The Snodgraft procedure is not superior to the Snodgrass operation in the narrow healthy urethral plate.",2020,The operative time was longer in group 2 than in group 1 but with comparable outcomes.,"['patients with urethral plate less than 8\xa0mm to repair distal hypospadias', '60 children who had been treated by the Snodgrass or Snodgraft procedure for repair of distal penile hypospadias with narrow urethral plate from March 2017 to September 2018', 'patients with a narrow urethral plate less than 8\xa0mm']",['Snodgrass vs Snodgraft procedure'],"['complete wound disruption and another of distal penile fistula', 'operative time', 'Operative details, postoperative period, and complications', 'distal penile fistula', 'complication rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0440785', 'cui_str': 'Urethral plate (substance)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0848558', 'cui_str': 'Hypospadias'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3839553', 'cui_str': 'Distal penile hypospadias (disorder)'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}]","[{'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",60.0,0.0213677,The operative time was longer in group 2 than in group 1 but with comparable outcomes.,"[{'ForeName': 'Mosaab', 'Initials': 'M', 'LastName': 'Eldeeb', 'Affiliation': 'Urology Department, Tanta University, Egypt.'}, {'ForeName': 'Salah', 'Initials': 'S', 'LastName': 'Nagla', 'Affiliation': 'Urology Department, Tanta University, Egypt. Electronic address: salahnaglah@yahoo.com.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abou-Farha', 'Affiliation': 'Urology Department, Tanta University, Egypt.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'Urology Department, Tanta University, Egypt.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.01.006']
575,32144049,Effects of Bladder Cancer on UK Healthcare Costs and Patient Health-Related Quality of Life: Evidence From the BOXIT Trial.,"BACKGROUND


Limited evidence exists regarding the cost and health-related quality of life (HRQoL) effects of non-muscle-invasive bladder cancer (NMIBC) recurrence and progression to muscle-invasive bladder cancer (MIBC). We examined these effects using evidence from a recent randomized control trial.
MATERIAL AND METHODS


The costs and HRQoL associated with bladder cancer were assessed using data from the BOXIT trial (bladder COX-2 inhibition trial; n = 472). The cost and HRQoL effects from clinical events were estimated using generalized estimating equations. The costs were derived from the recorded resource usage and UK unit costs. HRQoL was assessed using the EQ-5D-3L and reported UK preference tariffs. The events were categorized using the TMN classification.
RESULTS


Cases of grade 3 recurrence and progression were associated with statistically significant HRQoL decrements (-0.08; 95% confidence interval [CI], -0.13 to -0.03; and -0.10; 95% CI, -0.17 to -0.03, respectively). The 3-year average cost per NMIBC patient was estimated at £8735 (95% CI, 8325-9145). Cases of grade 1, 2, and 3 recurrence were associated with annual cost effects of £1218 (95% CI, 403-2033), £1677 (95% CI, 920-2433), and £3957 (95% CI, 2332-5583), respectively. Progression to MIBC was associated with an average increase in costs of £5407 (95% CI, 2663-8152).
CONCLUSION


Evidence from the BOXIT trial suggests that patients with NMIBC will both experience decrements in HRQoL and incur significant costs, especially in the event of a grade 3 recurrence or a progression to MIBC.",2020,"Progression to MIBC was associated with an average increase in costs of £5407 (95% CI, 2663-8152).
",[],[],"['UK Healthcare Costs and Patient Health-Related Quality of Life', 'cost and HRQoL effects', 'annual cost effects', '3-year average cost per NMIBC patient', 'costs and HRQoL associated with bladder cancer', 'HRQoL', 'HRQoL decrements']",[],[],"[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}]",,0.300627,"Progression to MIBC was associated with an average increase in costs of £5407 (95% CI, 2663-8152).
","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Centre for Health Economics, University of York, York, United Kingdom. Electronic address: edward.cox@york.ac.uk.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Saramago', 'Affiliation': 'Centre for Health Economics, University of York, York, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom; Department of Urology, University College London Hospital, London, United Kingdom.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Wei Shen', 'Initials': 'WS', 'LastName': 'Tan', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom; Department of Urology, Imperial College Healthcare, London, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sculpher', 'Affiliation': 'Centre for Health Economics, University of York, York, United Kingdom.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Soares', 'Affiliation': 'Centre for Health Economics, University of York, York, United Kingdom.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2019.12.004']
576,29547070,"'You already drank my beer, I can decide anything': using structuration theory to explore the dynamics of alcohol use, gender-based violence and HIV risk among female sex workers in Tanzania.","Female sex workers experience high rates of gender-based violence and HIV. Alcohol has been shown to facilitate women's risk of both gender-based violence and HIV; however, little research has explored how aspects of the sex work environment shape this risk. Drawing on structuration theory, this study explored how social conduct is patterned across time and space within the sex work environment to influence alcohol consumption, gender-based violence and HIV risk among female sex workers. Qualitative in-depth interviews were conducted with 24 female sex workers enrolled in an ongoing community randomised controlled trial of a combination HIV prevention intervention in Iringa, Tanzania. Data were analysed using both inductive and deductive approaches. Findings reveal how routine interactions between female sex workers and their clients occur at three moments of time and space during the sex exchange process to facilitate alcohol consumption and increase women's risk of gender-based violence and HIV. Findings also highlight how sex workers utilise collective agency to address aspects of the sex work environment that place them at risk of alcohol abuse, gender-based violence and HIV. Implications for future interventions to prevent gender-based violence and HIV among female sex workers in Tanzania and similar contexts are discussed.",2018,Implications for future interventions to prevent gender-based violence and HIV among female sex workers in Tanzania and similar contexts are discussed.,"['24 female sex workers enrolled', 'female sex workers in Tanzania', 'Female sex workers experience high rates of gender-based violence and HIV', 'female sex workers']",['combination HIV prevention intervention'],[],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0240816', 'cui_str': 'Prostitutes'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4505226', 'cui_str': 'Gender-Based Violence'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",[],24.0,0.0256018,Implications for future interventions to prevent gender-based violence and HIV among female sex workers in Tanzania and similar contexts are discussed.,"[{'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Leddy', 'Affiliation': 'a Department of Health, Behavior and Society , Johns Hopkins Bloomberg School of Public Health , Baltimore , MD , USA.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Kerrigan', 'Affiliation': 'a Department of Health, Behavior and Society , Johns Hopkins Bloomberg School of Public Health , Baltimore , MD , USA.'}, {'ForeName': 'Caitlin E', 'Initials': 'CE', 'LastName': 'Kennedy', 'Affiliation': 'b Department of International Health , Johns Hopkins Bloomberg School of Public Health , Baltimore , MD , USA.'}, {'ForeName': 'Jessie', 'Initials': 'J', 'LastName': 'Mbwambo', 'Affiliation': 'c Allied Sciences , Muhimbili University of Health , Dar es Salaam , Tanzania.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Likindikoki', 'Affiliation': 'c Allied Sciences , Muhimbili University of Health , Dar es Salaam , Tanzania.'}, {'ForeName': 'Carol R', 'Initials': 'CR', 'LastName': 'Underwood', 'Affiliation': 'a Department of Health, Behavior and Society , Johns Hopkins Bloomberg School of Public Health , Baltimore , MD , USA.'}]","Culture, health & sexuality",['10.1080/13691058.2018.1438667']
577,29679529,Influence of Human Milk and Parenteral Lipid Emulsions on Serum Fatty Acid Profiles in Extremely Preterm Infants.,"BACKGROUND


Infants born prematurely are at risk of a deficiency in ω-6 and ω-3 long-chain polyunsaturated fatty acids (LC-PUFAs) arachidonic acid (AA) and docosahexaenoic acid (DHA). We investigated how fatty acids from breast milk and parenteral lipid emulsions shape serum LC-PUFA profiles in extremely preterm infants during early perinatal life.
METHODS


Ninety infants born < 28 weeks gestational age were randomized to receive parenteral lipids with or without the ω-3 LC-PUFAs eicosapentaenoic acid (EPA) and DHA (SMOFlipid: Fresenius Kabi, Uppsala, Sweden, or Clinoleic: Baxter Medical AB, Kista, Sweden, respectively). The fatty acid composition of infant serum phospholipids was determined from birth to postmenstrual age 40 weeks, and in mother's milk total lipids on postnatal day 7. Enteral and parenteral intake of LC-PUFAs was correlated with levels in infant serum.
RESULTS


Infants administered parenteral ω-3 LC-PUFAs received 4.4 and 19.3 times more DHA and EPA, respectively, over the first 2 weeks of life. Parenteral EPA but not DHA correlated with levels in infant serum. We found linear relationships between dietary EPA and DHA and infant serum levels in the Clinoleic (Baxter Medical AB) group. The volume of administered SMOFlipid (Fresenius Kabi) was inversely correlated with serum AA, whereas Clinoleic (Baxter Medical AB) inversely correlated with serum EPA and DHA.
CONCLUSIONS


There appears to be no or low correlation between the amount of DHA administered parenterally and levels measured in serum. Whether this observation reflects serum phospholipid fraction only or truly represents the amount of accreted DHA needs to be investigated. None of the parenteral lipid emulsions satisfactorily maintained high levels of both ω-6 and ω-3 LC-PUFAs in infant serum.",2019,None of the parenteral lipid emulsions satisfactorily maintained high levels of both ω-6 and ω-3 LC-PUFAs in infant serum.,"['Extremely Preterm Infants', 'extremely preterm infants during early perinatal life', 'Ninety infants born < 28 weeks gestational age']","['Parenteral EPA', 'parenteral lipids with or without the ω-3 LC-PUFAs eicosapentaenoic acid (EPA) and DHA (SMOFlipid: Fresenius Kabi, Uppsala, Sweden, or Clinoleic', 'parenteral lipid emulsions', 'Human Milk and Parenteral Lipid Emulsions']","['fatty acid composition of infant serum phospholipids', 'Serum Fatty Acid Profiles', 'dietary EPA and DHA and infant serum levels', 'volume of administered SMOFlipid (Fresenius Kabi', 'levels of both ω-6 and ω-3 LC-PUFAs']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}]","[{'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C3252721', 'cui_str': 'ClinOleic'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0031676', 'cui_str': 'Phospholipids'}, {'cui': 'C0059057', 'cui_str': 'EPA (prealbumin)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]",90.0,0.0365893,None of the parenteral lipid emulsions satisfactorily maintained high levels of both ω-6 and ω-3 LC-PUFAs in infant serum.,"[{'ForeName': 'Anders K', 'Initials': 'AK', 'LastName': 'Nilsson', 'Affiliation': 'Section for Ophthalmology, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Chatarina', 'Initials': 'C', 'LastName': 'Löfqvist', 'Affiliation': 'Section for Ophthalmology, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Najm', 'Affiliation': 'Department of Paediatrics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Gunnel', 'Initials': 'G', 'LastName': 'Hellgren', 'Affiliation': 'Section for Ophthalmology, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Sävman', 'Affiliation': 'Department of Paediatrics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Mats X', 'Initials': 'MX', 'LastName': 'Andersson', 'Affiliation': 'Department of Biology and Environmental Sciences, The Faculty of Science, University of Gothenburg, Gothenburg.'}, {'ForeName': 'Lois E H', 'Initials': 'LEH', 'LastName': 'Smith', 'Affiliation': ""Department of Ophthalmology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hellström', 'Affiliation': 'Section for Ophthalmology, Department of Clinical Neuroscience, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1172']
578,31923066,Effect of Surgery for Stress Incontinence on Female Sexual Function.,"OBJECTIVE


To evaluate the effects of four different surgical interventions for stress urinary incontinence (SUI) on 2-year postoperative sexual function.
METHODS


This is a combined secondary analysis of SISTEr (Stress Incontinence Surgical Treatment Efficacy Trial) and TOMUS (Trial of Mid-Urethral Slings). Women in the original trials were randomized to receive surgical treatment for SUI with an autologous fascial sling or Burch colposuspension (SISTEr), or a retropubic or transobturator midurethral sling (TOMUS). Sexual function (assessed by the short version of the PISQ-12 [Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire]) was compared between groups at baseline, 12 and 24 months. Secondarily, the effects of subjective and objective surgical cure rates and the effect of concomitant surgical procedures on 24-month sexual function was explored.
RESULTS


Nine hundred twenty-four women were included in this study: 249 (26.9%) had an autologous fascial sling, 239 (25.9%) underwent Burch colposuspension, 216 (23.3%) had a retropubic midurethral sling placed, and 220 (23.8%) had transobturator midurethral sling placed. Baseline characteristics (including PISQ-12 scores) were similar between the four treatment arms, with notable exceptions including race-ethnicity, prolapse stage, concomitant surgery, and number of vaginal deliveries. After adjustment for differences between the groups, there was a clinically important improvement in PISQ-12 scores over the 24-month postoperative period for all treatment groups, with no significant differences attributed to the type of anti-incontinence procedure (baseline PISQ-12: 32.6, 33.1, 31.9, 31.4; 24-month PISQ-12: 37.7, 37.8, 36.9, 37.1, P<.01). There was no significant difference in mean PISQ-12 scores between 12 months and 24 months (12-month PISQ-12: 37.7, 37.8, 36.9, 37.1; 24 months as above, P=.97). Multivariable analysis showed independent associations between objective and subjective cure rates as well as concomitant procedures with a 24-month PISQ-12 score.
CONCLUSION


Women undergoing anti-incontinence surgery show overall improvement in sexual function from baseline to 24 months postoperatively, without significant differences based on surgical procedure performed. The majority of this improvement occurs in the first 12 months and is maintained over 24 months.",2020,"There was no significant difference in mean PISQ-12 scores between 12 months and 24 months (12-month PISQ-12: 37.7, 37.8, 36.9, 37.1; 24 months as above, P=.97).","['Nine hundred twenty-four women were included in this study: 249 (26.9%) had an autologous fascial sling, 239 (25.9%) underwent Burch colposuspension, 216 (23.3%) had a retropubic midurethral sling placed, and 220 (23.8%) had transobturator midurethral sling placed', 'Stress Incontinence on Female Sexual Function']","['surgical interventions', 'TOMUS', 'surgical treatment for SUI with an autologous fascial sling or Burch colposuspension (SISTEr), or a retropubic or transobturator midurethral sling (TOMUS', 'Surgery', 'concomitant surgical procedures']","['mean PISQ-12 scores', 'Sexual function', 'PISQ-12 [Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire', 'objective and subjective cure rates', 'Baseline characteristics (including PISQ-12 scores', 'PISQ-12 scores', 'type of anti-incontinence procedure', 'race-ethnicity, prolapse stage, concomitant surgery, and number of vaginal deliveries', 'sexual function', '24-month sexual function']","[{'cui': 'C4517900', 'cui_str': '900 (qualifier value)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0441637', 'cui_str': 'Slinging'}, {'cui': 'C0563527', 'cui_str': 'Colposuspension (procedure)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach (qualifier value)'}, {'cui': 'C3179501', 'cui_str': 'Midurethral Slings'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}]","[{'cui': 'C0549433', 'cui_str': 'Surgical intervention'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0441637', 'cui_str': 'Slinging'}, {'cui': 'C0563527', 'cui_str': 'Colposuspension (procedure)'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach (qualifier value)'}, {'cui': 'C3179501', 'cui_str': 'Midurethral Slings'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",924.0,0.049267,"There was no significant difference in mean PISQ-12 scores between 12 months and 24 months (12-month PISQ-12: 37.7, 37.8, 36.9, 37.1; 24 months as above, P=.97).","[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Glass Clark', 'Affiliation': 'Department of Obstetrics and Gynecology and the Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Virginia Commonwealth University Health System, and the Department of Biostatistics, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Sima', 'Affiliation': ''}, {'ForeName': 'Lauren N', 'Initials': 'LN', 'LastName': 'Siff', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003648']
579,28770459,"Effect of liraglutide on myocardial glucose uptake and blood flow in stable chronic heart failure patients: A double-blind, randomized, placebo-controlled LIVE sub-study.","BACKGROUND


The glucagon-like peptide-1 analog liraglutide increases heart rate and may be associated with more cardiac events in chronic heart failure (CHF) patients. We studied whether this could be ascribed to effects on myocardial glucose uptake (MGU), myocardial blood flow (MBF) and MBF reserve (MFR).
METHODS AND RESULTS


CHF patients with left ventricular ejection fraction ≤45% and without type 2 diabetes were randomized to liraglutide (N = 18) 1.8 mg once daily or placebo (N = 18) for 24 weeks in a double-blinded design. Changes in MGU during an oral glucose tolerance test (OGTT) and changes in MBF and MFR from baseline to follow-up were measured quantitatively by  18 F-FDG and  15 O-H 2 O positron emission tomography. Compared with placebo, liraglutide reduced weight (P = 0.03), HbA1c (P = 0.03) and the 2-hour glucose value during the OGTT (P = 0.004). Despite this, changes in MGU (P = 0.98), MBF (P = 0.76) and MFR (P = 0.89) from baseline to follow-up did not differ between groups. Furthermore, there was no association between the level of insulin resistance at baseline and changes in MGU in patients treated with liraglutide.
CONCLUSION


Liraglutide did not affect MGU, MBF, or MFR in non-diabetic CHF patients. Any potential increase in cardiac events in these patients seems not to involve changes in MGU, MBF, or MFR.
TRIAL REGISTRATION


Trial registry: http://www.ClinicalTrials.org . Identifier: NCT01472640. Url: https://clinicaltrials.gov/ct2/show/NCT01472640?term=NCT01472640&rank=1.",2019,"Compared with placebo, liraglutide reduced weight (P = 0.03), HbA1c (P = 0.03) and the 2-hour glucose value during the OGTT (P = 0.004).","['chronic heart failure (CHF) patients', 'stable chronic heart failure patients', 'CHF patients with left ventricular ejection fraction\xa0≤45% and without type 2 diabetes']","['placebo', 'placebo, liraglutide', 'liraglutide (N\xa0=\xa018) 1.8\xa0mg once daily or placebo (N\xa0', 'Liraglutide', 'liraglutide', 'glucagon-like peptide-1 analog liraglutide']","['cardiac events', 'MBF', '2-hour glucose value', 'heart rate', 'myocardial glucose uptake and blood flow', 'oral glucose tolerance test (OGTT) and changes in MBF and MFR', 'myocardial glucose uptake (MGU), myocardial blood flow (MBF) and MBF reserve (MFR', 'MGU, MBF, or MFR', 'level of insulin resistance', 'MFR', 'reduced weight']","[{'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1264663', 'cui_str': 'Mass fraction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]",,0.439985,"Compared with placebo, liraglutide reduced weight (P = 0.03), HbA1c (P = 0.03) and the 2-hour glucose value during the OGTT (P = 0.004).","[{'ForeName': 'Roni', 'Initials': 'R', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark. roni.r.nielsen@gmail.com.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Jorsal', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Iversen', 'Affiliation': 'Department of Nuclear Medicine & PET Centre, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Lars Poulsen', 'Initials': 'LP', 'LastName': 'Tolbod', 'Affiliation': 'Department of Nuclear Medicine & PET Centre, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Bouchelouche', 'Affiliation': 'Department of Nuclear Medicine & PET Centre, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Sørensen', 'Affiliation': 'Department of Nuclear Medicine & PET Centre, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Hendrik Johannes', 'Initials': 'HJ', 'LastName': 'Harms', 'Affiliation': 'Department of Nuclear Medicine & PET Centre, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Flyvbjerg', 'Affiliation': 'Faculty of Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Tarnow', 'Affiliation': 'Steno Diabetes Center, Gentofte, Denmark.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Herlev University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Hvidovre University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Wiggers', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N, Denmark.'}]",Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology,['10.1007/s12350-017-1000-2']
580,31337743,Prospective Effects of Manual Diaphragmatic Release and Thoracic Lymphatic Pumping in Childhood Asthma.,"BACKGROUND


Manual noninvasive respiratory techniques have traditionally been used to treat respiratory pathologies. The aim of this study was to analyze the effects of the diaphragmatic release technique and the thoracic lymphatic pump technique versus conventional respiratory retraining in children with asthma.
METHODS


Using a quasi-experimental design, 60 children with asthma were allocated to undergo the diaphragmatic release technique ( n  = 20), thoracic lymphatic pump technique ( n  = 20), or conventional respiratory retraining ( n  = 20) in this study. Serum immunoglobulin E levels, diaphragmatic mobility, pulmonary function, and P (A-a)O 2  were assessed before and after 12 treatment sessions that were conducted over nonconsecutive days in a 4-week program.
RESULTS


After 12 treatments, the changes in the serum immunoglobulin E level for each group was not significantly different from the other groups. Compared with conventional respiratory retraining, the diaphragmatic release technique was associated with a significant improvement in FVC ( P  = .001) and FEV 1  ( P  = .002); the thoracic lymphatic pump technique showed no differences. With regard to diaphragmatic mobility, both the diaphragmatic release technique and the thoracic lymphatic pump technique yielded significantly favorable effects when compared with conventional respiratory retraining ( P  < .001 and  P  = .01, respectively). Further, no significant between-group differences were detected in terms of the P (A-a)O 2  ( P  = .07).
CONCLUSIONS


The thoracic lymphatic pump technique and conventional respiratory retraining approaches were helpful interventions that could be used to alleviate the symptoms of childhood asthma. Nevertheless, the diaphragmatic release technique was a potentially more effective intervention.",2019,"After 12 treatments, the changes in the serum immunoglobulin E level for each group was not significantly different from the other groups.","['children with asthma', 'Childhood Asthma', '60 children with asthma']","['diaphragmatic release technique', 'thoracic lymphatic pump technique ( n  = 20), or conventional respiratory retraining', 'Manual Diaphragmatic Release and Thoracic Lymphatic Pumping', 'thoracic lymphatic pump technique versus conventional respiratory retraining']","['serum immunoglobulin E level', 'FVC', 'Serum immunoglobulin E levels, diaphragmatic mobility, pulmonary function, and P (A-a)O 2']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma (disorder)'}]","[{'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1562924', 'cui_str': 'Lymphatic pump'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0229889', 'cui_str': 'Structure of lymphatic vessel'}]","[{'cui': 'C0856520', 'cui_str': 'Serum immunoglobulin E'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",60.0,0.0180689,"After 12 treatments, the changes in the serum immunoglobulin E level for each group was not significantly different from the other groups.","[{'ForeName': 'Ragab K', 'Initials': 'RK', 'LastName': 'Elnaggar', 'Affiliation': 'Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University, Cairo, Egypt, and with the Department of Physical Therapy and Health Rehabilitation, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Kingdom of Saudi Arabia. rke_pt2001@yahoo.com.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Shendy', 'Affiliation': 'Department of Physical Therapy for Cardiovascular, Respiratory Disorders and Geriatrics, Faculty of Physical Therapy, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mostafa Z', 'Initials': 'MZ', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Radiology and Medical Imaging, College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University, Al-Kharj, Kingdom of Saudi Arabia.'}]",Respiratory care,['10.4187/respcare.06716']
581,31978436,Perioperative prophylactic internal iliac artery balloon occlusion in the prevention of postpartum hemorrhage in placenta previa: a randomized controlled trial.,"BACKGROUND


Placenta previa remains one of the major causes of massive postpartum hemorrhage and maternal mortality worldwide.
OBJECTIVE


To determine whether internal iliac artery balloon occlusion during cesarean delivery for placenta previa could reduce postpartum hemorrhage and other maternal complications.
STUDY DESIGN


This was a prospective randomized controlled trial conducted at a tertiary university obstetric unit in Hong Kong. Pregnant women who were diagnosed to have placenta previa at 34 weeks (defined as lower placenta edge within 2 cm from the internal os) and required cesarean delivery were invited to participate. Eligible pregnant women were randomized into internal iliac artery balloon occlusion (Occlusion) group or standard management (Control) group. Those randomized to the Occlusion group had internal iliac artery balloon catheter placement performed before cesarean delivery and then balloon inflation after delivery of the baby. The primary outcome was the reduction of postpartum hemorrhage in those with internal iliac artery balloon occlusion. Secondary outcome measures included hemoglobin drop after delivery; amount of blood product transfusion; incidence of hysterectomy; maternal complications including renal failure, ischemic liver, disseminated intravascular coagulation, and adult respiratory distress syndrome; length of stay in hospital; admission to intensive care unit; and maternal death.
RESULTS


Between May 2016 and September 2018, 40 women were randomized (20 in each group). Demographic and obstetric characteristics were similar between the 2 groups. In the Occlusion group, 3 women did not receive the scheduled procedure, as it was preceded by antepartum hemorrhage that required emergency cesarean delivery, and 1 woman had repeated scan at 36 weeks showing the placental edge was slightly more than 2 cm from the internal os. Intention-to-treat analysis found no significant differences between the Occlusion and the Control groups regarding to the median intraoperative blood loss (1451 [1024-2388] mL vs 1454 [888-2300] mL; P = .945), the median length of surgery (49 [30-62] min vs 37 [30-51] min; P = .204), or the need for blood transfusion during operation (57.9% vs 50.0%; P = .621). None of the patients had rebleeding after operation, complication related to internal iliac artery procedure, or any other maternal complications. Reanalyzing the data using on-treatment approach showed the same results.
CONCLUSION


The use of prophylactic internal iliac artery balloon occlusion in placenta previa patients undergoing cesarean delivery did not reduce postpartum hemorrhage or have any effect on maternal or neonatal morbidity.",2020,"None of the patients had rebleeding after operation, complication related to internal iliac artery procedure or any other maternal complications.","['ml vs 1454 (888-2300', 'tertiary university obstetric unit in Hong Kong', 'Eligible pregnant women', 'postpartum hemorrhage in placenta previa', 'Between May 2016 and Sep 2018, 40 women', 'placenta previa patients undergoing Cesarean delivery', 'Pregnant women who were diagnosed to have placenta previa at 34 weeks (defined as lower placenta edge within 2cm from the internal os) and required Cesarean delivery were invited to participate']","['Occlusion Group had internal iliac artery balloon catheter placement', 'internal iliac artery balloon occlusion (Occlusion) group or standard management (Control) group', 'internal iliac artery balloon occlusion', 'prophylactic internal iliac artery balloon occlusion', 'Perioperative prophylactic internal iliac artery balloon occlusion']","['hemoglobin drop after delivery, amount of blood product transfusion, incidence of hysterectomy, maternal complications including renal failure, ischemic liver, disseminated intravascular coagulation, adult respiratory distress syndrome, length of stay in hospital, admission to intensive care unit, and maternal death', 'median length of surgery', 'median intra-operative blood loss', 'reduction of postpartum hemorrhage in those with internal iliac artery balloon occlusion', 'postpartum hemorrhage', 'Demographic and obstetric characteristics', 'need for blood transfusion']","[{'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0032046', 'cui_str': 'Placenta Previa'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0032043', 'cui_str': 'Placentome'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0227842', 'cui_str': 'Structure of internal os'}]","[{'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0226364', 'cui_str': 'Structure of internal iliac artery'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0005841', 'cui_str': 'Blood Transfusion'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0012739', 'cui_str': 'Consumption Coagulopathy'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit (procedure)'}, {'cui': 'C3494405', 'cui_str': 'Maternal Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0226364', 'cui_str': 'Structure of internal iliac artery'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}]",40.0,0.221838,"None of the patients had rebleeding after operation, complication related to internal iliac artery procedure or any other maternal complications.","[{'ForeName': 'Simon Chun Ho', 'Initials': 'SCH', 'LastName': 'Yu', 'Affiliation': 'Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Yvonne Kwun Yue', 'Initials': 'YKY', 'LastName': 'Cheng', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Wing Ting', 'Initials': 'WT', 'LastName': 'Tse', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Daljit Singh', 'Initials': 'DS', 'LastName': 'Sahota', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Man Yan', 'Initials': 'MY', 'LastName': 'Chung', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Simon Sin Man', 'Initials': 'SSM', 'LastName': 'Wong', 'Affiliation': 'Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Oi Ka', 'Initials': 'OK', 'LastName': 'Chan', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Tak Yeung', 'Initials': 'TY', 'LastName': 'Leung', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong. Electronic address: tyleung@cuhk.edu.hk.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.01.024']
582,31127753,Effects of oscillatory mobilization as compared to sustained stretch mobilization in the management of cervical radiculopathy: A randomized controlled trial.,"BACKGROUND


Cervical radiculopathy is a relatively common musculoskeletal disorder resulting in a significant social and occupational impact. Manual therapy is thought to provide relief in cervical radiculopathy; however, evidence is lacking regarding the comparison of different manual therapy concepts.
OBJECTIVE


To determine the effects of Maitland's oscillatory mobilization as compared to Kaltenborn's sustained stretch mobilization in the management of cervical radiculopathy.
METHODS


A randomized controlled trial was conducted at Fauji Foundation Hospital comprising of 46 patients randomized into oscillatory and sustained stretch mobilization groups. Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI) and cervical range of motion (ROM) were used as outcome variables.
RESULTS


No significant differences were observed at base line between the two groups (P> 0.05) except for ROM in extension and left side bending (P< 0.05). In terms of pre and post treatment comparison, P value of less than 0.05 was observed for both groups, indicating both treatments to be effective in isolation. However, post treatment comparison between both groups showed oscillatory mobilization to be superior to sustained stretch mobilization (P< 0.05) in the management of cervical radiculopathy except for the outcomes of pain and side bending.
CONCLUSION


Both oscillatory and sustained stretch mobilization techniques are found to be effective in the management of cervical radiculopathy in terms of pain, range and disability. However, oscillatory mobilization is found to be superior in terms of functional ability and range of motion.",2020,No significant differences were observed at base line between the two groups (P> 0.05) except for ROM in extension and left side bending (P< 0.05).,"['cervical radiculopathy', 'Fauji Foundation Hospital comprising of 46 patients randomized into oscillatory and sustained stretch mobilization groups']","['oscillatory mobilization', ""Maitland's oscillatory mobilization"", 'Manual therapy']","['sustained stretch mobilization', 'ROM in extension and left side bending', 'oscillatory mobilization', 'Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI) and cervical range of motion (ROM']","[{'cui': 'C0742186', 'cui_str': 'Radiculopathy, Cervical'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0454525', 'cui_str': 'Manual Therapies'}]","[{'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205133', 'cui_str': 'Bent (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}]",46.0,0.055946,No significant differences were observed at base line between the two groups (P> 0.05) except for ROM in extension and left side bending (P< 0.05).,"[{'ForeName': 'Furqan', 'Initials': 'F', 'LastName': 'Hassan', 'Affiliation': 'Institute of Rehabilitation Sciences, Foundation University Islamabad, Islamabad, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Osama', 'Affiliation': 'Institute of Rehabilitation Sciences, Foundation University Islamabad, Islamabad, Pakistan.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Ghafoor', 'Affiliation': 'Riphah International University, Islamabad, Pakistan.'}, {'ForeName': 'Muhammad Furqan', 'Initials': 'MF', 'LastName': 'Yaqoob', 'Affiliation': 'Institute of Rehabilitation Sciences, Foundation University Islamabad, Islamabad, Pakistan.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-170914']
583,31970062,"Brain Glucose Metabolism, Cognition, and Cardiorespiratory Fitness Following Exercise Training in Adults at Risk for Alzheimer's Disease.","Aerobic exercise has been associated with reduced burden of brain and cognitive changes related to Alzheimer's disease (AD). However, it is unknown whether exercise training in asymptomatic individuals harboring risk for AD improves outcomes associated with AD. We investigated the effect of 26 weeks of supervised aerobic treadmill exercise training on brain glucose metabolism and cognition among 23 late-middle-aged adults from a cohort enriched with familial and genetic risk of AD. They were randomized to Usual Physical Activity (PA) or Enhanced PA conditions. Usual PA received instruction about maintaining an active lifestyle. Enhanced PA completed a progressive exercise training program consisting of 3 sessions of treadmill walking per week for 26 weeks. By week seven, participants exercised at 70- 80% heart rate reserve for 50 minutes per session to achieve 150 minutes of moderate intensity activity per week in accordance with public health guidelines. Before and after the intervention, participants completed a graded treadmill test to assess VO 2 peak as a measure of cardiorespiratory fitness (CRF), wore an accelerometer to measure free-living PA, underwent  18 F-fluorodeoxyglucose positron emission tomography imaging to assess brain glucose metabolism, and a neuropsychological battery to assess episodic memory and executive function. VO 2 peak increased, sedentary behavior decreased, and moderate-to-vigorous PA increased significantly in the Enhanced PA group as compared to Usual PA. Glucose metabolism in the posterior cingulate cortex (PCC) did not change significantly in Enhanced PA relative to Usual PA. However, change in PCC glucose metabolism correlated positively with change in VO 2 peak. Executive function, but not episodic memory, was significantly improved after Enhanced PA relative to Usual PA. Improvement in executive function correlated with increased VO 2 peak. Favorable CRF adaptation after 26 weeks of aerobic exercise training was associated with improvements in PCC glucose metabolism and executive function, important markers of AD.",2019,"VO 2 peak increased, sedentary behavior decreased, and moderate-to-vigorous PA increased significantly in the Enhanced PA group as compared to Usual PA.","[""Adults at Risk for Alzheimer's Disease"", '23 late-middle-aged adults from a cohort enriched with familial and genetic risk of AD']","['Exercise Training', 'Usual Physical Activity (PA) or Enhanced PA conditions', 'Aerobic exercise', 'graded treadmill test to assess VO 2 peak as a measure of cardiorespiratory fitness (CRF), wore an accelerometer to measure free-living PA, underwent  18 F-fluorodeoxyglucose positron emission tomography imaging', 'exercise training', 'supervised aerobic treadmill exercise training', 'aerobic exercise training']","['brain glucose metabolism and cognition', 'sedentary behavior', 'Executive function', 'Glucose metabolism', 'Favorable CRF adaptation', 'PCC glucose metabolism and executive function, important markers of AD', 'PCC glucose metabolism', 'executive function', 'moderate-to-vigorous PA', 'Brain Glucose Metabolism, Cognition, and Cardiorespiratory Fitness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C1611743', 'cui_str': 'Familial (FPAH)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0087110', 'cui_str': 'Treadmill Test'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0302995', 'cui_str': '18F radioisotope'}, {'cui': 'C4553797', 'cui_str': 'Fluorodeoxyglucose'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0044609', 'cui_str': '1-piperidinocyclohexanecarbonitrile'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",,0.0459203,"VO 2 peak increased, sedentary behavior decreased, and moderate-to-vigorous PA increased significantly in the Enhanced PA group as compared to Usual PA.","[{'ForeName': 'Julian M', 'Initials': 'JM', 'LastName': 'Gaitán', 'Affiliation': ""Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.""}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Boots', 'Affiliation': ""Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.""}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Dougherty', 'Affiliation': ""Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.""}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Oh', 'Affiliation': ""Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.""}, {'ForeName': 'Dorothy F', 'Initials': 'DF', 'LastName': 'Edwards', 'Affiliation': ""Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.""}, {'ForeName': 'Bradley T', 'Initials': 'BT', 'LastName': 'Christian', 'Affiliation': ""Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.""}, {'ForeName': 'Dane B', 'Initials': 'DB', 'LastName': 'Cook', 'Affiliation': 'Department of Kinesiology, University of Wisconsin School of Education, Madison, WI, USA.'}, {'ForeName': 'Ozioma C', 'Initials': 'OC', 'LastName': 'Okonkwo', 'Affiliation': ""Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.""}]","Brain plasticity (Amsterdam, Netherlands)",['10.3233/BPL-190093']
584,31981307,Influence of angle kappa-customized implantation of rotationally asymmetric multifocal intraocular lens on visual quality and patient satisfaction.,"PURPOSE


To evaluate the visual outcomes and patient satisfaction with angle kappa-customized implantation of SBL-3 (Lenstec, Inc.; +3 D), a rotationally asymmetric multifocal intraocular lens (MIOL).
METHODS


This was a prospective randomized control study. Data from consecutive patients, who underwent bilateral implantation of SBL-3 MIOL from June 2017 to August 2018, were enrolled in the study. One eye of each patient was randomly chosen to receive a horizontal IOL placement (control group), while the other eye received angle kappa-customized placement (design group). The outcomes include uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA), defocus curve, contrast sensitivity, quality of vision and patient satisfaction. The follow-up was 3 months.
RESULTS


The study enrolled 80 eyes of 40 patients. There was no significant difference in mean UDVA, UIVA and UNVA between the two groups. The design group showed significantly better visual acuity at -1.50 D of defocus, based on the defocus curve (p = 0.022), and less vertical coma (p = 0.002) than the control group. No significant differences in contrast sensitivity, modulation transfer function, Strehl ratio and patient satisfaction were found between the two groups.
CONCLUSION


Angle kappa-customized implantation of SBL-3 had little impact on visual outcomes and patient satisfaction, except for a moderate impact on intermediate visual acuity.",2020,"No significant differences in contrast sensitivity, modulation transfer function, Strehl ratio and patient satisfaction were found between the two groups.
","['study enrolled 80 eyes of 40 patients', 'consecutive patients, who underwent bilateral implantation of SBL-3 MIOL from June 2017 to August 2018, were enrolled in the study']","['angle kappa-customized implantation of SBL-3 (Lenstec, Inc.; +3 D), a rotationally asymmetric multifocal intraocular lens (MIOL', 'horizontal IOL placement (control group), while the other eye received angle kappa-customized placement', 'angle kappa-customized implantation of rotationally asymmetric multifocal intraocular lens']","['vertical coma', 'visual acuity', 'intermediate visual acuity', 'contrast sensitivity, modulation transfer function, Strehl ratio and patient satisfaction', 'mean UDVA, UIVA and UNVA', 'visual quality and patient satisfaction', 'uncorrected distance visual acuity (UDVA), uncorrected intermediate visual acuity (UIVA), uncorrected near visual acuity (UNVA), defocus curve, contrast sensitivity, quality of vision and patient satisfaction', 'visual outcomes and patient satisfaction']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0604837', 'cui_str': 'Miol'}]","[{'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0205292', 'cui_str': 'Multifocal (qualifier value)'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C0604837', 'cui_str': 'Miol'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1690987', 'cui_str': 'Intermediate visual acuity'}, {'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0429541', 'cui_str': 'Near visual acuity (observable entity)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}]",80.0,0.131966,"No significant differences in contrast sensitivity, modulation transfer function, Strehl ratio and patient satisfaction were found between the two groups.
","[{'ForeName': 'Yiyun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Yufei', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Rongjun', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Chenxi', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Baikai', 'Initials': 'B', 'LastName': 'Ma', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Jinhong', 'Initials': 'J', 'LastName': 'Miao', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Qi', 'Affiliation': 'Department of Ophthalmology, Peking University Third Hospital, Beijing, China.'}]",Acta ophthalmologica,['10.1111/aos.14356']
585,31965170,Sensitivity of the Nipple-Areola Complex in Reduction Mammaplasty Following Periareolar Dermis Section.,"BACKGROUND


Preservation of the periareolar dermis, after de-epithelization in reduction mammaplasty, may result in reduced nipple-areola complex (NAC) mobility. Consequently, distortion in shape and difficulty correcting the areola position can occur.
OBJECTIVES


The aim of this study was to evaluate NAC viability and sensitivity resulting from periareolar dermis section after de-epithelization in patients who underwent reduction mammaplasty surgery.
METHODS


This study was a randomized, controlled double-blind clinical trial. A total of 41 patients (82 breasts) were randomly allocated into 2 groups and underwent reduction mammaplasty-involving the superior pedicle-with a final inverted T-shaped scar. A sectioning of the periareolar dermis was performed on the breasts in the experimental group. Semmes-Weinstein monofilaments were used to evaluate NAC sensitivity at the preoperative evaluation, and 3, 6, and 52 weeks after surgery.
RESULTS


No cases of partial or total NAC necrosis were noted in either group. The comparison between the groups did not show significant differences regarding NAC sensitivity. However, a statistically significant difference was noted when sensitivity levels at the preoperative evaluation and 3 weeks after surgery were compared in the experimental group. A significant difference was noted when the scores of the sensitivity 3 weeks after surgery were compared between the control and the experiment groups. Nevertheless, after 1 year, no statistical differences were observed in the experimental group or between both groups.
CONCLUSIONS


The sectioning of the periareolar dermis does not affect the viability or the pressure sensitivity of the NAC.
LEVEL OF EVIDENCE: 4


",2020,A significant difference was noted when the scores of the sensitivity three weeks after surgery were compared between the control and the experiment groups.,"['patients who underwent reduction mammaplasty surgery', '41 patients (82 breasts']",['reduction mammaplasty - using the superior pedicle - with a final inverted T-shaped scar'],"['NAC sensitivity', 'partial or total NAC necrosis', 'sensitivity levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0191922', 'cui_str': 'Breast reduction'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0006141', 'cui_str': 'Breast'}]","[{'cui': 'C0191922', 'cui_str': 'Breast reduction'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0456605', 'cui_str': 'Pedicle (substance)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0439636', 'cui_str': 'Inverted-T (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",41.0,0.0269908,A significant difference was noted when the scores of the sensitivity three weeks after surgery were compared between the control and the experiment groups.,"[{'ForeName': 'Jairo Zacchê', 'Initials': 'JZ', 'LastName': 'de Sá', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Antônio Carlos Côrte Real', 'Initials': 'ACCR', 'LastName': 'Braga', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Rafael Henrique Coutinho', 'Initials': 'RHC', 'LastName': 'Barreto', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Anderson da Silva', 'Initials': 'ADS', 'LastName': 'Ramos', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Amanda Estelita', 'Initials': 'AE', 'LastName': 'de Oliveira Rodrigues', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Santa-Cruz', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}, {'ForeName': 'José Lamartine de Andrade', 'Initials': 'JLA', 'LastName': 'Aguiar', 'Affiliation': 'Federal University of Pernambuco, Recife, PE, Brazil.'}]",Aesthetic surgery journal,['10.1093/asj/sjaa011']
586,31959650,Response to Comment on Nauck et al. Effects of Liraglutide Compared With Placebo on Events of Acute Gallbladder or Biliary Disease in Patients With Type 2 Diabetes at High Risk for Cardiovascular Events in the LEADER Randomized Trial. Diabetes Care 2019;42:1912-1920.,,2020,,"['Patients With Type 2 Diabetes at High Risk for Cardiovascular Events', 'Diabetes']","['Placebo', 'Liraglutide']",['Acute Gallbladder or Biliary Disease'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0016976', 'cui_str': 'Gallbladder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.051179,,"[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Division, St. Josef-Hospital (Ruhr University), Bochum, Germany michael.nauck@rub.de.'}, {'ForeName': 'Eskil', 'Initials': 'E', 'LastName': 'Kreiner', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Hans A', 'Initials': 'HA', 'LastName': 'Saevereid', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dci19-0067']
587,31959014,Low- Versus Moderate-Sodium Diet in Patients With Recent Hospitalization for Heart Failure: The PROHIBIT (Prevent Adverse Outcomes in Heart Failure by Limiting Sodium) Pilot Study.,"BACKGROUND


We conducted a pilot study to assess feasibility, on-study retention, trends in natriuretic peptide levels, quality of life, and safety of a 12-week feeding trial with 1500- versus 3000-mg daily sodium meals in high-risk patients with heart failure.
METHODS


Of 196 patients with recent (≤2 weeks) hospitalization for heart failure, ejection fraction ≤40%, on optimal medical therapy, functionally independent, and able to communicate, 83 (47%) consented to participate. Of these, 27 (age, 62±11 years; 22 men; 20 white; ejection fraction, 26±8%) had 24-hour urine sodium ≥3000 mg and agreed to randomly receive either 1500-mg (N=12) or 3000-mg (N=15) sodium meals.
RESULTS


On-study retention at 12 weeks was 77% (82% versus 73%;  P =0.53); 6 patients (2 in 1500-mg, 4 in 3000-mg arm) withdrew before study completion. Food satisfaction questionnaires indicated that both diets were well tolerated. Quality of life improved in the 1500-mg arm at 12 weeks but did not change in the 3000-mg arm. Average compliance with meals was 52% (based on urinary sodium) and was not significantly different between arms (42% versus 60%;  P =0.25). Study meals reduced 24-hour urinary sodium by 137±21 mmol (1500-mg arm) and 82±16 mmol (3000-mg arm), both  P <0.001; between-arms difference was 55 mmol (95% CI, 3-107;  P =0.037). NT-proBNP (N-terminal pro-B-type natriuretic peptide) was not affected. Hospitalizations and low blood pressure events did not differ significantly between arms. Serum creatinine decreased more (by 0.17 mg/dL [95% CI, 0.06-0.28];  P =0.003) in the 1500-mg arm. Creatinine increases >0.5 mg/dL over baseline only occurred in 1 patient in the 3000-mg arm.
CONCLUSIONS


Even with prepared meals, investigating optimal dietary sodium in heart failure comes with challenges, including need for extensive screening, reluctance to participate, and compliance issues. Because both diets reduced urinary sodium without adverse safety or quality of life signals, a larger trial, with modifications to improve participation and compliance, would be ethical and feasible.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT02467296.",2020,Quality of life improved in the 1500-mg arm at 12 weeks but did not change in the 3000-mg arm.,"['Of 196 patients with recent (≤2 weeks) hospitalization for heart failure, ejection fraction ≤40%, on optimal medical therapy, functionally independent, and able to communicate, 83 (47%) consented to participate', 'Patients', '27 (age, 62±11 years; 22 men; 20 white; ejection fraction, 26±8%) had 24-hour urine sodium ≥3000 mg and agreed to randomly receive either 1500-mg (N=12) or 3000-mg (N=15', 'high-risk patients with heart failure']","['Low', '1500- versus 3000-mg daily sodium meals', 'sodium meals', 'NT-proBNP', 'Moderate-Sodium Diet']","['Average compliance with meals', 'Serum creatinine', 'natriuretic peptide levels, quality of life, and safety', 'Creatinine', 'tolerated', 'Quality of life', '24-hour urinary sodium', 'Food satisfaction questionnaires', 'Hospitalizations and low blood pressure events']","[{'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C4273559', 'cui_str': 'Functionally independent'}, {'cui': 'C2364293', 'cui_str': 'Able to communicate (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1256585', 'cui_str': 'Sodium measurement, urine (procedure)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0301592', 'cui_str': 'Sodium diet (finding)'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",196.0,0.0541266,Quality of life improved in the 1500-mg arm at 12 weeks but did not change in the 3000-mg arm.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kalogeropoulos', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, NY (A.K., L.P., H.S.).'}, {'ForeName': 'Lampros', 'Initials': 'L', 'LastName': 'Papadimitriou', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, NY (A.K., L.P., H.S.).'}, {'ForeName': 'Vasiliki V', 'Initials': 'VV', 'LastName': 'Georgiopoulou', 'Affiliation': 'Department of Medicine (V.V.G.), Emory University, Atlanta, GA.'}, {'ForeName': 'Sandra B', 'Initials': 'SB', 'LastName': 'Dunbar', 'Affiliation': 'School of Nursing (S.B.D.), Emory University, Atlanta, GA.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Skopicki', 'Affiliation': 'Division of Cardiology, Department of Medicine, Stony Brook University, NY (A.K., L.P., H.S.).'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi, Jackson (L.P., J.B.).'}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006389']
588,31957468,Mechanistic Effects of Spironolactone on Cardiovascular and Renal Biomarkers in Heart Failure With Preserved Ejection Fraction: A TOPCAT Biorepository Study.,"BACKGROUND


Spironolactone has been demonstrated to reduce heart failure (HF) hospitalization in patients with HF with preserved ejection fraction in the Americas region of the TOPCAT trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial). We assessed effects of 12 months of treatment with spironolactone on biomarkers reflecting myocardial stress, myocardial injury, renal function, and systemic inflammation.
METHODS


This TOPCAT biorepository substudy evaluated 247 patients (14% of the total 1767 patients in the Americas region) with symptomatic HF, ejection fraction ≥45%, and elevated natriuretic peptides or a prior HF hospitalization. Paired blood samples at baseline and after 12 months of treatment with spironolactone or placebo were available in 204 patients.
RESULTS


At baseline, the median (interquartile range) concentration of BNP (B-type natriuretic peptide) was 124 (69-197) ng/L, NT-proBNP (N-terminal-pro-B-type natriuretic peptide) 624 (307-1312) ng/L, hs-cTnI (high sensitivity cardiac troponin I) 6.3 (3.4-13.0) ng/L, hs-CRP (high sensitivity C-reactive protein) 2.8 (1.3-6.1) mg/L, uric acid 7.2 (5.8-8.7) mg/dL, and urine protein-creatinine ratio 0.11 (0.08-0.20) mg/mg. Compared with placebo-assigned participants at 12 months, those randomized to spironolactone experienced greater reductions from baseline in levels of NT-proBNP ( P =0.017) and BNP ( P =0.002); these differences persisted after adjustment for demographics, comorbidities, estimated glomerular filtration rate, and enrollment strata. No between-group differences in changes in hs-cTnI, CRP, uric acid, or urine protein-creatinine ratio were observed.
CONCLUSIONS


This TOPCAT biorepository substudy suggests potential effects on markers of cardiac wall stress or filling pressures during 12 months of treatment with spironolactone in patients with chronic HF with preserved ejection fraction.
CLINICAL TRIAL REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT00094302.",2020,"No between-group differences in changes in hs-cTnI, CRP, uric acid, or urine protein-creatinine ratio were observed.
","['204 patients', 'patients with chronic HF with preserved ejection fraction', 'patients with HF with preserved ejection fraction in the Americas region of the TOPCAT trial (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist Trial', '247 patients (14% of the total 1767 patients in the Americas region) with symptomatic HF, ejection fraction ≥45%, and elevated natriuretic peptides or a prior HF hospitalization', 'Heart Failure']","['placebo', 'Preserved Ejection Fraction', 'proBNP', 'spironolactone', 'spironolactone or placebo', 'Spironolactone']","['levels of NT-proBNP', 'heart failure (HF) hospitalization', 'median (interquartile range) concentration of BNP (B-type natriuretic peptide', 'biomarkers reflecting myocardial stress, myocardial injury, renal function, and systemic inflammation', 'changes in hs-cTnI, CRP, uric acid, or urine protein-creatinine ratio', 'Cardiovascular and Renal Biomarkers', 'cardiac wall stress or filling pressures', 'BNP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone Antagonists'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C1305628', 'cui_str': 'Urine protein (substance)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",1767.0,0.506504,"No between-group differences in changes in hs-cTnI, CRP, uric acid, or urine protein-creatinine ratio were observed.
","[{'ForeName': 'Peder L', 'Initials': 'PL', 'LastName': 'Myhre', 'Affiliation': ""Cardiovascular Division (P.L.M., M.V., B.L.C., S.D.S., M.A.P., A.S.D.), Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division (P.L.M., M.V., B.L.C., S.D.S., M.A.P., A.S.D.), Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Montreal Heart Institute, University of Montreal, Canada (E.O.M., S.d.D., J.L.R.).'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division (P.L.M., M.V., B.L.C., S.D.S., M.A.P., A.S.D.), Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'de Denus', 'Affiliation': 'Montreal Heart Institute, University of Montreal, Canada (E.O.M., S.d.D., J.L.R.).'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jarolim', 'Affiliation': ""Department of Pathology (P.J.), Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiovascular Medicine, University of Minnesota (I.S.A.).'}, {'ForeName': 'Bertram', 'Initials': 'B', 'LastName': 'Pitt', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor (B.P.).'}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute, University of Montreal, Canada (E.O.M., S.d.D., J.L.R.).'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division (P.L.M., M.V., B.L.C., S.D.S., M.A.P., A.S.D.), Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Pfeffer', 'Affiliation': ""Cardiovascular Division (P.L.M., M.V., B.L.C., S.D.S., M.A.P., A.S.D.), Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division (P.L.M., M.V., B.L.C., S.D.S., M.A.P., A.S.D.), Brigham and Women's Hospital, Boston, MA.""}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.119.006638']
589,32144735,Preoperative concurrent endocrine therapy with chemotherapy in luminal B-like breast cancer.,"PURPOSE


Luminal B-like breast cancer is sensitive to both chemotherapy and endocrine therapy. We aimed to assess the safety and efficacy of concomitant chemotherapy and endocrine therapy compared with chemotherapy alone in the preoperative setting in luminal B-like breast cancer.
METHODS


This two-arm randomized clinical trial enrolled patients with luminal B-like human epithelial growth factor 2-negative breast cancer, who were randomly assigned at a 1:1 ratio to receive preoperative chemotherapy alone or preoperative endocrine therapy concurrent with chemotherapy for 24 weeks before surgery. The primary endpoint was the pathological complete response (pCR) rate. The secondary endpoints included the clinical response rate, toxicity, and health-related quality of life (HRQOL).
RESULTS


Overall, 70 patients were randomly assigned to the chemotherapy and chemo-endocrine therapy groups. The pCR rates were 9.7% and 3.0% (P = 0.319), and the clinical complete response rates were 5.9% and 5.6% (P = 0.745) in the chemotherapy and chemo-endocrine therapy groups, respectively. There were no clear differences in treatment-related adverse events or HRQOL between the two groups.
CONCLUSIONS


In patients with luminal B-like breast cancer, the pCR, clinical response rate, toxicity, and HRQOL with the concomitant administration of endocrine therapy and chemotherapy were not superior to chemotherapy alone in the preoperative setting.",2020,"The pCR rates were 9.7% and 3.0% (P = 0.319), and the clinical complete response rates were 5.9% and 5.6% (P = 0.745) in the chemotherapy and chemo-endocrine therapy groups, respectively.","['70 patients', 'patients with luminal B-like human epithelial growth factor 2-negative breast cancer', 'luminal B-like breast cancer']","['preoperative chemotherapy alone or preoperative endocrine therapy concurrent with chemotherapy', 'concomitant chemotherapy and endocrine therapy', 'chemotherapy alone', 'Preoperative concurrent endocrine therapy with chemotherapy', 'chemotherapy and chemo-endocrine therapy', 'endocrine therapy and chemotherapy']","['clinical complete response rates', 'pCR rates', 'pathological complete response (pCR) rate', 'clinical response rate, toxicity, and health-related quality of life (HRQOL', 'adverse events or HRQOL', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",70.0,0.0363706,"The pCR rates were 9.7% and 3.0% (P = 0.319), and the clinical complete response rates were 5.9% and 5.6% (P = 0.745) in the chemotherapy and chemo-endocrine therapy groups, respectively.","[{'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Matsunuma', 'Affiliation': 'First Department of Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, 431-3192, Japan. r-matsunuma@nifty.com.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Department of Medical Oncology, Hamamatsu Oncology Center, Hamamatsu, Shizuoka, 430-0929, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Hozumi', 'Affiliation': 'Department of Breast Surgery, Jichi Medical University Hospital, Shimotsuke, Tochigi, 329-0498, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Koizumi', 'Affiliation': 'First Department of Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, 431-3192, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Ito', 'Affiliation': 'Department of Breast Surgery, Iwata City Hospital, Iwata, Shizuoka, 438-8550, Japan.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Maruyama', 'Affiliation': 'Department of Surgery, Seirei Mikatahara General Hospital, Hamamatsu, Shizuoka, 433-8558, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Ogura', 'Affiliation': 'First Department of Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, 431-3192, Japan.'}, {'ForeName': 'Keigo', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Department of Breast Surgery, Iwata City Hospital, Iwata, Shizuoka, 438-8550, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Mori', 'Affiliation': 'Department of Breast Surgery, Hamamatsu Medical Center, Hamamatsu, Shizuoka, 432-8580, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Sawai', 'Affiliation': 'Department of Medical Oncology, Hamamatsu Oncology Center, Hamamatsu, Shizuoka, 430-0929, Japan.'}, {'ForeName': 'Norihiko', 'Initials': 'N', 'LastName': 'Shiiya', 'Affiliation': 'First Department of Surgery, Hamamatsu University School of Medicine, Hamamatsu, Shizuoka, 431-3192, Japan.'}]","Breast cancer (Tokyo, Japan)",['10.1007/s12282-020-01077-0']
590,32122284,Racial exclusion causes acute cortisol release among emerging-adult African Americans: The role of reduced perceived control.,"Racial discrimination contributes to stress-related health disparities among African Americans, but less is known about the acute effects of racial exclusion on the hypo-pituitary-adrenocortical response and psychological mediators. Participants were 276 Black/African American emerging-adults (54% female;  M   age  = 21.74,  SD  = 2.21) who were randomly assigned to be excluded or included by White peers via the game Cyberball. Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885,  p  < .0001), lower perceived control ( F (1, 276) = 205.523,  p  < .0001), and greater cortisol release ( F (1, 274) = 4.575,  p  = .033). Racial exclusion's impact on cortisol release was mediated by lower perceived control (95% CI: .027, .112), but not negative affect (-.041, .013). These findings suggest that racial exclusion contributes to acute cortisol release, and that reduced perceived control is a consequence of racial discrimination that has important implications for the health of those who experience discrimination.",2020,"Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885,  ","['African Americans', 'adult African Americans', 'Participants were 276 Black/African American emerging-adults (54% female;  M age \xa0=\xa021.74,  SD \xa0=\xa02.21) who were randomly assigned to be excluded or included by White peers via the game Cyberball']",[],"['greater cortisol release', 'cortisol release']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517630', 'cui_str': '2.21'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}]",[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]",276.0,0.0475374,"Racial exclusion (vs. inclusion) predicted: greater negative affect ( F (1, 276) = 104.885,  ","[{'ForeName': 'Laurel M', 'Initials': 'LM', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychology, Bryn Mawr College.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Stock', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Monroe', 'Affiliation': 'Department of Psychology, Bryn Mawr College.'}, {'ForeName': 'Brianne K', 'Initials': 'BK', 'LastName': 'Molloy-Paolillo', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}, {'ForeName': 'Sharon F', 'Initials': 'SF', 'LastName': 'Lambert', 'Affiliation': 'Department of Psychological and Brain Sciences, The George Washington University.'}]",The Journal of social psychology,['10.1080/00224545.2020.1729685']
591,29924703,Markers of Renal Function in Older Adults Completing a Higher Protein Obesity Intervention and One Year Later: Findings from the MEASUR-UP Trial.,"Increases in rates of obesity in the older population are hastening the development of chronic illnesses, including chronic kidney disease (CKD). However, obesity reduction in older adults is besought with concerns about the long-term benefit/risk, especially regarding loss of muscle mass and its impact on function. Higher protein intakes have been advocated to help offset the tendency for loss of muscle during weight reduction but this raises concerns about possible negative effects on older kidneys. We assessed markers of renal function in venous blood samples collected during a six-month randomized controlled weight loss trial of higher protein intake in obese (n = 67; BMI ≥ 30 kg/m 2 ) older (≥60 years) adults with physical frailty and age-normal renal status (glomerular filtration rate [GFR] ≥ 45); the Control diet (0.8 g protein/kg body weight/day; n = 21) was compared to a protein-enhanced (1.2 g/g protein/kg body weight/day with 30 g protein/meal; n = 41; Protein) diet. Results showed no group effect of the Protein treatment on markers of renal function (estimated GFR, blood urea nitrogen, and creatinine), either upon intervention completion or one year later. Our findings align with literature support for the benefits of higher protein in the diets of older individuals during obesity reduction and help to confirm the safety of moderate increases in protein intake during weight loss in this population.",2018,"Results showed no group effect of the Protein treatment on markers of renal function (estimated GFR, blood urea nitrogen, and creatinine), either upon intervention completion or one year later.","['venous blood samples collected during a six-month randomized controlled weight loss trial of higher protein intake in obese (n\u2009=\u200967; BMI\u2009≥\u200930\u2009kg/m 2 ) older (≥60\u2009years) adults with physical frailty and age-normal renal status (glomerular filtration rate [GFR]\u2009≥\u200945); the Control diet (0.8\u2009g protein/kg body weight/day; n\u2009=\u200921', 'Older Adults', 'older adults']",['protein-enhanced (1.2\u2009g/g protein/kg body weight/day with 30\u2009g protein/meal; n\u2009=\u200941; Protein) diet'],"['rates of obesity', 'markers of renal function (estimated GFR, blood urea nitrogen, and creatinine', 'obesity reduction']","[{'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0530867', 'cui_str': 'G13 Protein'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0530867', 'cui_str': 'G13 Protein'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C4524116', 'cui_str': 'Estimated GFR'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen (substance)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0188317,"Results showed no group effect of the Protein treatment on markers of renal function (estimated GFR, blood urea nitrogen, and creatinine), either upon intervention completion or one year later.","[{'ForeName': 'Kathryn N', 'Initials': 'KN', 'LastName': 'Porter Starr', 'Affiliation': 'a Center for the Study of Aging , Duke University School of Medicine , Durham , NC , USA.'}, {'ForeName': 'Shelley R', 'Initials': 'SR', 'LastName': 'McDonald', 'Affiliation': 'a Center for the Study of Aging , Duke University School of Medicine , Durham , NC , USA.'}, {'ForeName': 'Aubrey', 'Initials': 'A', 'LastName': 'Jarman', 'Affiliation': 'a Center for the Study of Aging , Duke University School of Medicine , Durham , NC , USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Orenduff', 'Affiliation': 'a Center for the Study of Aging , Duke University School of Medicine , Durham , NC , USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sloane', 'Affiliation': 'a Center for the Study of Aging , Duke University School of Medicine , Durham , NC , USA.'}, {'ForeName': 'Carl F', 'Initials': 'CF', 'LastName': 'Pieper', 'Affiliation': 'a Center for the Study of Aging , Duke University School of Medicine , Durham , NC , USA.'}, {'ForeName': 'Connie W', 'Initials': 'CW', 'LastName': 'Bales', 'Affiliation': 'a Center for the Study of Aging , Duke University School of Medicine , Durham , NC , USA.'}]",Journal of nutrition in gerontology and geriatrics,['10.1080/21551197.2018.1478696']
592,31984593,Influence of foraminal enlargement on the apical extrusion of filling material: Volumetric analysis using micro-computed tomography.,"The aim of this study was to compare the root canal instrumentation techniques that involve foraminal enlargement versus those not involving it, in regard to the apical extrusion of filling material, using micro-computed tomography (micro-CT). Twenty-two premolars with single canals were instrumented using the ProTaper Universal System and then randomly divided into two groups (n = 11): Group NFE, without foraminal enlargement, and Group FE, with foraminal enlargement. Instrumentation was performed up to 1 mm short of the apical foramen, and foraminal patency was maintained at each instrument change in both groups. Prior to obturation, the apical portion of the specimens was wrapped in adhesive paper to ensure complete separation between apex and extruded material. The canals were filled according to the continuous wave of condensation technique. The apically extruded material was collected and measured using micro-CT. Extrusion in Group FE was significantly higher than in Group NFE (0.928 mm 3  vs. 0.148 mm 3  ; P < 0.001).",2020,Extrusion in Group FE was significantly higher than in Group NFE (0.928 mm 3  vs. 0.148 mm 3  ; P < 0.001).,['Twenty-two premolars with single canals'],['micro-computed tomography'],[],"[{'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0442636', 'cui_str': 'Canal (environment)'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]",[],22.0,0.0149458,Extrusion in Group FE was significantly higher than in Group NFE (0.928 mm 3  vs. 0.148 mm 3  ; P < 0.001).,"[{'ForeName': 'Patrícia Pereira', 'Initials': 'PP', 'LastName': 'Albuquerque', 'Affiliation': 'Faculdade São Leopoldo Mandic, Instituto de Pesquisas São Leopoldo Mandic, Campinas, Brazil.'}, {'ForeName': 'Marco Antonio', 'Initials': 'MA', 'LastName': 'Hungaro Duarte', 'Affiliation': 'Department of Restorative Dentistry, Endodontics and Dental Materials, School of Dentistry of Bauru, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Rina Andréa', 'Initials': 'RA', 'LastName': 'Pelegrine', 'Affiliation': 'Faculdade São Leopoldo Mandic, Instituto de Pesquisas São Leopoldo Mandic, Campinas, Brazil.'}, {'ForeName': 'Augusto Shoji', 'Initials': 'AS', 'LastName': 'Kato', 'Affiliation': 'Faculdade São Leopoldo Mandic, Instituto de Pesquisas São Leopoldo Mandic, Campinas, Brazil.'}, {'ForeName': 'Carolina Pessoa', 'Initials': 'CP', 'LastName': 'Stringheta', 'Affiliation': 'Faculdade São Leopoldo Mandic, Instituto de Pesquisas São Leopoldo Mandic, Campinas, Brazil.'}, {'ForeName': 'Jussaro Alves', 'Initials': 'JA', 'LastName': 'Duque', 'Affiliation': 'Department of Restorative Dentistry, Endodontics and Dental Materials, School of Dentistry of Bauru, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Carlos Eduardo da Silveira', 'Initials': 'CEDS', 'LastName': 'Bueno', 'Affiliation': 'Faculdade São Leopoldo Mandic, Instituto de Pesquisas São Leopoldo Mandic, Campinas, Brazil.'}]",Australian endodontic journal : the journal of the Australian Society of Endodontology Inc,['10.1111/aej.12394']
593,31970906,Appetite-Related Responses to Overfeeding and Longitudinal Weight Change in Obesity-Prone and Obesity-Resistant Adults.,"OBJECTIVE


Appetite responses to 3 days of overfeeding (OF) were examined as correlates of longitudinal weight change in adults classified as obesity prone (OP) or obesity resistant (OR).
METHODS


OP (n = 22) and OR (n = 30) adults consumed a controlled eucaloric and OF diet (140% of energy needs) for 3 days, followed by 3 days of ad libitum feeding. Hunger and satiety were evaluated by visual analog scales. Ghrelin and peptide YY (PYY) levels were measured during a 24-hour inpatient visit on day 3. Body weight and composition were measured annually for 4.0 ± 1.3 years.
RESULTS


Dietary restraint and disinhibition were greater in OP than OR (mean difference: 3.5 ± 1.2 and 3.3 ± 0.9, respectively; P < 0.01) participants, and disinhibition was associated with longitudinal weight change (n = 48; r = 0.35; P = 0.02). Compared with the eucaloric diet, energy intake fell significantly in OR participants following OF (P = 0.03) but not in OP (P = 0.33) participants. Twenty-four-hour PYY area under the curve values increased with OF in OR (P = 0.02) but not in OP (P = 0.17) participants. Furthermore, changes in PYY levels with OF correlated with measured energy intake (r = -0.36; P = 0.01).
CONCLUSIONS


Baseline disinhibition and PYY responses to OF differed between OP and OR adults. Dietary disinhibition was associated with 5-year longitudinal weight gain. Differences in appetite regulation may underlie differences in propensity for weight gain.",2020,Twenty-four-hour PYY area under the curve values increased with OF in OR (P = 0.02) but not in OP (P = 0.17) participants.,"['adults classified as obesity prone (OP) or obesity resistant (OR', 'Obesity-Prone and Obesity-Resistant Adults', 'OP (n\u2009=\u200922) and OR (n\u2009=\u200930) adults']",['consumed a controlled eucaloric and OF diet'],"['Hunger and satiety', 'Ghrelin and peptide YY (PYY) levels', 'visual analog scales', 'Dietary disinhibition', 'Body weight and composition', 'energy intake fell', '5-year longitudinal weight gain', 'longitudinal weight change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0234410', 'cui_str': 'Disinhibition, function (observable entity)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",,0.100239,Twenty-four-hour PYY area under the curve values increased with OF in OR (P = 0.02) but not in OP (P = 0.17) participants.,"[{'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Halliday', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Corey A', 'Initials': 'CA', 'LastName': 'Rynders', 'Affiliation': ""Center for Women's Health Research, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Thomas', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Bergouignan', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Zhaoxing', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Department of Pediatrics, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Kealey', 'Affiliation': 'Anschutz Health and Wellness Center, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Marc-Andre', 'Initials': 'MA', 'LastName': 'Cornier', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Bessesen', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado, Anschutz Medical Campus, Aurora, Colorado, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22687']
594,31985352,Letter To The Journal.,"The paper ""Short-term Mediterranean Diet Improves Endurance Exercise Performance: A Randomized-Sequence Crossover Trial"" (1), which was published in the Journal of the American College of Nutrition is based on the results of 11 individuals who each ran twice on a treadmill. The authors report that there was 6% decrease in the time required to run 5k after eating a Mediterranean diet for 4 days before the second run. The interpretation of the data is complicated by the small sample size and the fact that the results are highly skewed. The authors state that means and standard deviation of the two sets of data are ""(27.09 ± 3.55 vs. 28.59 ± 3.21;  p  = 0.030)"", thereby implying that the test is a comparison of the means. However, the p refers to the result for a paired t-test. The authors discuss the several limitations of this study, but these limitations focus on the diets. They do not discuss how the fact that the testing is not blind may affect the results. It is stated that ""recreationally active"" 20-60 tear olds were recruited for this study ""from the general population in metropolitan St. Louis, MO"". However, the runners tested had a tight range of run times (27.09 ± 3.55), age (28 ± 3), and BMI (24.6 ± 3.2). This hardly seems like a random sample of this group.",2020,"However, the runners tested had a tight range of run times (27.09 ± 3.55), age (28 ± 3), and BMI (24.6 ± 3.2).","['recreationally active"" 20-60 tear olds were recruited for this study ""from the general population in metropolitan St. Louis, MO', '11 individuals who each ran twice on a treadmill']",[],['Endurance Exercise Performance'],"[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}]",[],"[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}]",11.0,0.031695,"However, the runners tested had a tight range of run times (27.09 ± 3.55), age (28 ± 3), and BMI (24.6 ± 3.2).","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Masten', 'Affiliation': 'Department of Civil and Environmental Engineering, Michigan State University, Michigan, USA.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2019.1648068']
595,31960896,VYC-25L Hyaluronic Acid Injectable Gel Is Safe and Effective for Long-Term Restoration and Creation of Volume of the Lower Face.,"BACKGROUND


Juvéderm Volux (VYC-25L; Allergan plc) is an injectable hyaluronic acid gel designed to restore and create facial volume.
OBJECTIVE


The aim of this study was to evaluate the safety and effectiveness of Volux for chin retrusion over 18 months and after repeat treatment.
METHODS


This prospective, single-blind, controlled study enrolled subjects aged ≥18 years with chin retrusion (glabella-subnasale-pogonion facial angle 145°-165°). Subjects were randomized (3:1) to Volux at study onset or 3 months later (control group), and could receive a single repeat treatment during months 18 to 24. Assessments included mean facial-angle change from baseline, Global Aesthetic Improvement Scale (GAIS) responder rates (improved/much improved), improvements in 3 subject-reported FACE-Q scales, and safety.
RESULTS


Of 132 enrolled subjects, 119 received initial Volux treatment and 89 received repeat treatment. Mean changes (95% confidence interval) in glabella-subnasale-pogonion angle from baseline for treatment and control groups, respectively, were: 1.15° (0.75°, 1.56°) and 1.16° (0.57°, 1.75°) at month 18, and 3.14° (2.68°, 3.61°) and 2.72° (1.78°, 3.66°) 1 month after repeat treatment. Investigators rated 52.5%/60.0% of treated/control subjects at month 18 and 96.9%/100% after retreatment as GAIS responders; subject-reported rates were 62.0%/64.0% and 93.8%/100%. Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-Being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment. The safety profile was as expected.
CONCLUSIONS


Volux injectable gel is a safe, effective, and durable alternative to surgical treatments for increasing chin projection and jaw volume, and results in high patient satisfaction.
LEVEL OF EVIDENCE: 2


",2020,"Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment.","['132 enrolled subjects, 119 received initial Volux treatment and 89 received repeat treatment', 'enrolled subjects aged ≥18 years with chin retrusion (glabella-subnasale-pogonion facial angle 145°-165°']",['VYC-25L Hyaluronic Acid Injectable Gel'],"['FACE-Q scales, and safety', 'Mean changes', 'Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-being', 'mean facial-angle change from baseline, Global Aesthetic Improvement Scale (GAIS) responder rates']","[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0222694', 'cui_str': 'Structure of glabella'}, {'cui': 'C2334731', 'cui_str': 'Cephalometric pogonion point'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0008114', 'cui_str': 'Mentum'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}]",132.0,0.0218295,"Durable improvements in Satisfaction with Chin, Satisfaction with Lower Face and Jawline, and Psychological Well-being were reported in 82.1%, 78.2%, and 60.3% of subjects, respectively, at month 18, and 92.3%, 93.8%, and 67.7% of subjects after retreatment.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ogilvie', 'Affiliation': ''}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Benouaiche', 'Affiliation': ''}, {'ForeName': 'Wolfgang G', 'Initials': 'WG', 'LastName': 'Philipp-Dormston', 'Affiliation': ''}, {'ForeName': 'Lakhdar', 'Initials': 'L', 'LastName': 'Belhaouari', 'Affiliation': ''}, {'ForeName': 'Frodo', 'Initials': 'F', 'LastName': 'Gaymans', 'Affiliation': ''}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Sattler', 'Affiliation': ''}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Harvey', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Schumacher', 'Affiliation': ''}]",Aesthetic surgery journal,['10.1093/asj/sjaa013']
596,31954158,Patient-centered change in the day-to-day impact of postmenopausal vaginal symptoms: results from a multicenter randomized trial.,"BACKGROUND


Vulvovaginal symptoms, which include dryness, irritation, and pain with intercourse, are common among postmenopausal women and are associated with impaired sexual functioning and quality of life. Previous assessment of treatment strategies for these symptoms has been limited by a lack of sensitive patient-centered outcome measures that assess symptom impact on functional and quality-of-life domains.
OBJECTIVE


We aimed to (1) examine change in the impact of postmenopausal vulvovaginal symptoms on multiple aspects of well-being and functioning in relation to vaginal estradiol and moisturizer treatment and (2) guide meaningful interpretation of scores on a structured-item questionnaire measure of condition-specific impact.
STUDY DESIGN


Data were drawn from postmenopausal women who were enrolled in the Menopause Strategies: Finding Lasting Answers for Symptoms and Health Vaginal Health Trial (a 12-week, double-blind, placebo-controlled randomized trial of treatment for vulvovaginal symptoms) who were assigned to vaginal 10-μg estradiol tablet plus placebo gel (n=98), vaginal moisturizer plus placebo tablet (n=97), or dual placebo (n=94). At baseline and 12-week follow up, participants completed the Day-to-Day Impact of Vaginal Aging questionnaire to assess the impact of vaginal symptoms on 4 domains (activities of daily living, emotional well-being, sexual functioning, and body image), each on a 0-4 point scale. Day-to-Day Impact of Vaginal Aging sensitivity to change was assessed by the examination of the associations between change in Day-to-Day Impact of Vaginal Aging domain scores and vulvovaginal symptom severity from baseline to 12 weeks with analysis of covariance. Within-woman and between-group minimal clinically important improvement was assessed with the use of an anchor-based approach that relates change in Day-to-Day Impact of Vaginal Aging domain scores with self-reported benefit from treatment.
RESULTS


Participants in all treatment arms (n=289) demonstrated reduced impact of vulvovaginal symptoms on all domains of well-being and functioning as assessed by Day-to-Day Impact of Vaginal Aging at 12-week follow up, with no significant differences in improvement between women who were assigned to either estradiol tablet or vaginal moisturizer compared with placebo. For all Day-to-Day Impact of Vaginal Aging domains, mean impact scores were reduced when participants reported symptom improvement (-0.3 to -0.8 point change in Day-to-Day Impact of Vaginal Aging scores for <2-point symptom severity change vs -0.4 to -1.6 point change in Day-to-Day Impact of Vaginal Aging scores for 2+ point symptom severity change; all P<.001). Minimal clinically important change in Day-to-Day Impact of Vaginal Aging domain scale scores, which are anchored to self-reported meaningful benefit from treatment at 12 weeks, ranged from -0.4 to -1.3 (within-woman) and -0.2 to -0.7 (between-group). Observed change and minimal clinically important difference were largest for the sexual functioning domain.
CONCLUSION


The impact of vulvovaginal symptoms on day-to-day activities, sexual function, emotional well-being, and body image may be improved with low-dose vaginal estradiol, moisturizer, or topical placebo. The Day-to-Day Impact of Vaginal Aging questionnaire demonstrates sensitivity to change with treatment of vulvovaginal symptoms, particularly Day-to-Day Impact of Vaginal Aging scales that focus on symptom impact on sexual functioning and body image. Minimal clinically important improvement in the impact of vulvovaginal symptoms as measured by the Day-to-Day Impact of Vaginal Aging can be defined with the use of these measures.",2020,,['Postmenopausal Vaginal Symptoms'],[],[],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],[],,0.0982499,,"[{'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Gibson', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, CA; Department of Psychiatry, University of California, San Francisco, CA. Electronic address: Carolyn.Gibson2@va.gov.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Larson', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Mitchell', 'Affiliation': 'Vincent Obstetrics and Gynecology, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Diem', 'Affiliation': 'Department of Medicine and Epidemiology and Community Health, University of Minnesota, Minneapolis, MN; Department of Medicine, Minneapolis VA Health Care System, Minneapolis, MN.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'LaCroix', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, CA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Newton', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Washington, Seattle, WA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.12.270']
597,31661578,Effects of genotype on TENS effectiveness in controlling knee pain in persons with mild to moderate osteoarthritis.,"BACKGROUND


This study examined the extent to which genetic variability modifies Transcutaneous Electrical Nerve Stimulation (TENS) effectiveness in osteoarthritic knee pain.
METHODS


Seventy-five participants with knee osteoarthritis were randomly assigned to either: (a) High-frequency TENS, (b) Low-frequency TENS or (c) Transient Placebo TENS. Pain measures were collected pre- and post-treatment. Participants were genotyped on genes implicated in central or peripheral pain pathways: NGFB, NTRK1, EDNRA, EDNRB, EDN1, OPRM1, TAC1, TACR1, BDNF, BDKRB1, 5HTT, COMT, ESR2, IL6 and IL1B. Genetic association using linear regression modelling was performed separately for the transient placebo TENS subjects, and within the High-frequency TENS + Low-frequency TENS participants, including TENS level as a covariate.
RESULTS


In the placebo group, SNPs rs165599 (COMT) was significantly associated with an increased heat pain threshold (β = -1.87; p = .003) and rs6827096 (EDNRA) with an increased resting pain (β = 2.68; p = .001). Within the treatment groups, TENS effectiveness was reduced by the SNP rs6537485 (EDNRA) minor allele in relationship to mechanical sensation (β = 184.13; p = 5.5E-9). Individuals with the COMT rs4680 minor allele reported lowered pain at rest after TENS (β = -42.30; p = .001), with a higher magnitude of pain reduction (28 unit difference) in the low-frequency TENS group compared to the high-frequency TENS group (β = 28.37; p = .0004).
CONCLUSIONS


EDNRA and COMT are implicated in osteoarthritic knee pain and provide a basis for tailoring TENS interventions according to individual characteristics.
SIGNIFICANCE


Findings from this study demonstrate that genetic variation within the COMT and EDNRA genes influences the effectiveness of TENS, a non-pharmacologic pain-reduction intervention, in the context of osteoarthritic knee pain. Evidence such as this may contribute to risk models that provide a clinically useful tool for personalizing TENS interventions according to individual characteristics in order to best control pain and maximize functional status.",2020,"In the placebo group, SNPs rs165599 (COMT) was significantly associated with an increased heat pain threshold (β = -1.87; p = .003) and rs6827096 (EDNRA) with an increased resting pain (β = 2.68; p = .001).","['Seventy-five participants with knee osteoarthritis', 'persons with mild to moderate osteoarthritis', 'osteoarthritic knee pain']","['placebo', 'Transcutaneous Electrical Nerve Stimulation (TENS', 'High Frequency TENS, 2) Low Frequency TENS, or 3) Transient Placebo TENS']","['TENS effectiveness', 'lowered pain', 'osteoarthritic knee pain', 'resting pain', 'Pain measures', 'pain reduction', 'heat pain threshold', 'SNPs rs165599 (COMT']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}]",75.0,0.0531762,"In the placebo group, SNPs rs165599 (COMT) was significantly associated with an increased heat pain threshold (β = -1.87; p = .003) and rs6827096 (EDNRA) with an increased resting pain (β = 2.68; p = .001).","[{'ForeName': 'Manika', 'Initials': 'M', 'LastName': 'Govil', 'Affiliation': 'Department of Oral Biology, Center for Craniofacial and Dental Genetics, School of Dental Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Nandita', 'Initials': 'N', 'LastName': 'Mukhopadhyay', 'Affiliation': 'Department of Oral Biology, Center for Craniofacial and Dental Genetics, School of Dental Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Holwerda', 'Affiliation': 'Mary Free Bed Rehabilitation Spine Center, Grand Rapids, MI, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Sluka', 'Affiliation': 'Graduate Program in Physical Therapy and Rehabilitation, The University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Rakel', 'Affiliation': 'The University of Iowa College of Nursing, Iowa City, IA, USA.'}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Schutte', 'Affiliation': 'Wayne State University College of Nursing, Detroit, MI, USA.'}]","European journal of pain (London, England)",['10.1002/ejp.1497']
598,31742670,Promoting colonoscopy screening among low-income Latinos at average risk of colorectal cancer: A randomized clinical trial.,"BACKGROUND


Screening colonoscopy (SC) for colorectal cancer (CRC) is underused by Latino individuals. The current randomized clinical trial examined the impact of 3 interventions: 1) patient navigation; 2) patient navigation plus standard Centers for Disease Control and Prevention print materials; and 3) patient navigation plus culturally targeted print materials for Latinos referred for SC. Demographic, personal and health history, and psychometric factors associated with SC also were examined.
METHODS


A total of 344 urban Latino individuals aged 50 to 85 years with no personal and/or immediate family history of CRC diagnosed before age 60 years, no personal history of a gastrointestinal disorder, no colonoscopy within the past 5 years, with insurance coverage, and with a referral for SC were consented. Participants were randomized to patient navigation (20%), patient navigation plus standard Centers for Disease Control and Prevention print materials (40%), and patient navigation plus culturally targeted print materials (40%). The completion of SC was assessed at 12 months.
RESULTS


The interventions had an overall SC rate of 82%. Counterintuitively, patients with an average income of <$10,000 were found to have higher SC rates (87%) than those with a greater income (75%).
CONCLUSIONS


The addition of standard or culturally targeted print materials did not appear to increase SC rates above those for patient navigation. Indeed, after controlling for other variables, culturally targeted print materials were found to be associated with lower SC rates among Puerto Rican individuals.",2020,"Indeed, after controlling for other variables, culturally targeted print materials were found to be associated with lower SC rates among Puerto Rican individuals.","['Latino individuals', '344 urban Latino individuals aged 50 to 85\xa0years with no personal and/or immediate family history of CRC diagnosed before age 60\xa0years, no personal history of a gastrointestinal disorder, no colonoscopy within the past 5\xa0years, with insurance coverage, and with a referral for SC were consented', 'low-income Latinos at average risk of colorectal cancer']","['patient navigation plus standard Centers for Disease Control and Prevention print materials (40%), and patient navigation plus culturally targeted print materials', 'Screening colonoscopy (SC', 'patient navigation; 2) patient navigation plus standard Centers for Disease Control and Prevention print materials; and 3) patient navigation plus culturally targeted print materials for Latinos referred for SC']","['overall SC rate', 'SC rates']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0424945', 'cui_str': 'Social / personal history observable'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0376629', 'cui_str': 'Insurance Status'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C0034036', 'cui_str': 'Publications'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0568607,"Indeed, after controlling for other variables, culturally targeted print materials were found to be associated with lower SC rates among Puerto Rican individuals.","[{'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'DuHamel', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, Icahn Medical Institute, New York, New York.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Schofield', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Villagra', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, Icahn Medical Institute, New York, New York.'}, {'ForeName': 'Pathu', 'Initials': 'P', 'LastName': 'Sriphanlop', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, Icahn Medical Institute, New York, New York.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Itzkowitz', 'Affiliation': 'Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Cotter', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, Icahn Medical Institute, New York, New York.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Cohen', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, Icahn Medical Institute, New York, New York.'}, {'ForeName': 'Deborah O', 'Initials': 'DO', 'LastName': 'Erwin', 'Affiliation': 'Cancer Prevention and Control, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Winkel', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, Icahn Medical Institute, New York, New York.'}, {'ForeName': 'Hayley S', 'Initials': 'HS', 'LastName': 'Thompson', 'Affiliation': 'Department of Community Outreach and Engagement, Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, Michigan.'}, {'ForeName': 'Ann G', 'Initials': 'AG', 'LastName': 'Zauber', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Lina H', 'Initials': 'LH', 'LastName': 'Jandorf', 'Affiliation': 'Department of Population Health Sciences and Policy, Icahn School of Medicine at Mount Sinai, Icahn Medical Institute, New York, New York.'}]",Cancer,['10.1002/cncr.32541']
599,31930507,Toward precision therapeutics: general and specific factors differentiate symptom change in depressed adolescents.,"BACKGROUND


The longitudinal course of multiple symptom domains in adolescents treated for major depression is not known. Revealing the temporal course of general and specific psychopathology factors, including potential differences between psychotherapies, may aid therapeutic decision-making.
METHODS


Participants were adolescents with major depressive disorder (aged 11-17; 75% female; N = 465) who were part of the IMPACT trial, a randomized controlled trial comparing cognitive behavioral therapy, short-term psychoanalytic psychotherapy, and brief psychosocial intervention. Self-reported symptoms at baseline and 6, 12, 36, 52, and 86 weeks postrandomization were analyzed with bifactor modeling.
RESULTS


General psychopathology factor scores decreased across treatment and one-year follow-up. Specific melancholic features and depressive cognitions factors decreased from baseline to 6 weeks. Conduct problems decreased across treatment and follow-up. Anxiety increased by 6 weeks and then reverted to baseline levels. Obsessions-compulsions did not change. Changes in general and specific factors were not significantly different between the three psychotherapies during treatment. During follow-up, however, conduct problems decreased more in brief psychosocial intervention versus cognitive behavioral therapy (1.02, 95% Bayes credible interval 0.25, 1.96), but not versus short-term psychoanalytic psychotherapy.
CONCLUSIONS


The clinical response signature in this trial is best revealed by rapid reductions in depression symptoms and general psychopathology. Protracted improvements in general psychopathology and conduct problems subsequently occur. Psychosocial treatments for adolescent depression have comparable effects on general and specific psychopathology, although a psychoeducational, goal-focused approach may be indicated for youth with comorbid conduct problems.",2020,"During follow-up, however, conduct problems decreased more in brief psychosocial intervention versus cognitive behavioral therapy (1.02, 95% Bayes credible interval 0.25, 1.96), but not versus short-term psychoanalytic psychotherapy.
","['depressed adolescents', 'Participants were adolescents with major depressive disorder (aged 11-17; 75% female; N\xa0=\xa0465) who were part of the IMPACT trial']","['cognitive behavioral therapy, short-term psychoanalytic psychotherapy, and brief psychosocial intervention', 'psychosocial intervention versus cognitive behavioral therapy']","['General psychopathology factor scores', 'Obsessions-compulsions', 'Anxiety', 'Specific melancholic features and depressive cognitions factors']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0233697', 'cui_str': 'Obsessions'}, {'cui': 'C0600104', 'cui_str': 'Compulsive Behavior'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",465.0,0.0743996,"During follow-up, however, conduct problems decreased more in brief psychosocial intervention versus cognitive behavioral therapy (1.02, 95% Bayes credible interval 0.25, 1.96), but not versus short-term psychoanalytic psychotherapy.
","[{'ForeName': 'Madison', 'Initials': 'M', 'LastName': 'Aitken', 'Affiliation': 'Cundill Centre for Child and Youth Depression, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Haltigan', 'Affiliation': 'Cundill Centre for Child and Youth Depression, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Szatmari', 'Affiliation': 'Cundill Centre for Child and Youth Depression, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Bernadka', 'Initials': 'B', 'LastName': 'Dubicka', 'Affiliation': 'Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Division of Psychology and Language Sciences, University College London, London, UK.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Kelvin', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Midgley', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Reynolds', 'Affiliation': 'School of Psychology and Clinical Language Sciences, University of Reading, Reading, UK.'}, {'ForeName': 'Paul O', 'Initials': 'PO', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Goodyer', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13194']
600,31563641,Tildrakizumab efficacy and safety are not altered by metabolic syndrome status in patients with psoriasis: Post hoc analysis of 2 phase 3 randomized controlled studies (reSURFACE 1 and reSURFACE 2).,,2020,,['Patients With Psoriasis'],[],['Tildrakizumab Efficacy and Safety'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]",[],"[{'cui': 'C4043954', 'cui_str': 'tildrakizumab'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0383807,,"[{'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Lebwohl', 'Affiliation': 'Department of Dermatology, Mount Sinai Hospital, New York, New York. Electronic address: lebwohl@aol.com.'}, {'ForeName': 'Craig L', 'Initials': 'CL', 'LastName': 'Leonardi', 'Affiliation': 'Central Dermatology and Saint Louis University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Nehal N', 'Initials': 'NN', 'LastName': 'Mehta', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Mendelsohn', 'Affiliation': 'Sun Pharmaceutical Industries, Inc, Princeton, New Jersey.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Parno', 'Affiliation': 'Sun Pharmaceutical Industries, Inc, Princeton, New Jersey.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Rozzo', 'Affiliation': 'Sun Pharmaceutical Industries, Inc, Princeton, New Jersey.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Division of Dermatology, Baylor Scott & White, and Texas A&M College of Medicine, Dallas, Texas.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.09.042']
601,30626911,"A phase 2, double-blind, placebo-controlled study of NSI-189 phosphate, a neurogenic compound, among outpatients with major depressive disorder.","NSI-189 is a novel neurogenic compound independent of monoamine reuptake pathways. This trial evaluated oral NSI-189 as monotherapy in major depressive disorder. To improve signal detection, the sequential-parallel comparison design (SPCD) was chosen. Two hundred and twenty subjects were randomized to NSI-189 40 mg daily, 80 mg daily, or placebo for 12 weeks. The primary outcome measure was the Montogmery Asberg Depression Rating Scale (MADRS). Secondary subject-rated measures included the Symptoms of Depression Questionnaire (SDQ), the Cognitive and Physical Functioning Scale (CPFQ), the patient-rated version of the Quick Inventory of Depressive Symptomatology Scale (QIDS-SR), and subtests from the CogScreen and Cogstate cognitive tests. MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively). However, the 40 mg dose showed greater overall reduction in SDQ (pooled mean difference -8.2; Cohen's d for Stages 1 and 2 = -0.11 and -0.64, p = 0.04), and CPFQ scores (pooled mean difference -1.9; Cohen's d for Stages 1 and 2 = -0.28 and -0.47, p = 0.03) versus placebo, as well as QIDS-SR scores in Stage 2 of SPCD (-2.5; Cohen's d Stages 1 and 2 = -0.03 and -0.68, p = 0.04). The 40 mg dose also showed advantages on some objective cognitive measures of the CogScreen (absolute Cohen's d ranged between 0.12 and 1.12 in favor of NSI-189, p values between 0.002 and 0.048 for those with overall significance), but not the Cogstate test. Both doses were well tolerated. These findings replicate those of phase 1b study, and warrant further exploration of the antidepressant and pro-cognitive effects of NSI-189.",2020,"MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively).","['major depressive disorder', 'Two hundred and twenty subjects were randomized to NSI-189 40', 'outpatients with major depressive disorder']","['NSI-189 phosphate', 'NSI-189', 'placebo']","['Montogmery Asberg Depression Rating Scale (MADRS', 'MADRS score reduction', 'Symptoms of Depression Questionnaire (SDQ), the Cognitive and Physical Functioning Scale (CPFQ), the patient-rated version of the Quick Inventory of Depressive Symptomatology Scale (QIDS-SR), and subtests from the CogScreen and Cogstate cognitive tests', 'QIDS-SR scores', 'tolerated', 'overall reduction in SDQ', 'objective cognitive measures of the CogScreen', 'CPFQ scores']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C4507670', 'cui_str': 'NSI-189'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C4507671', 'cui_str': 'NSI-189 phosphate'}, {'cui': 'C4507670', 'cui_str': 'NSI-189'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",220.0,0.16936,"MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively).","[{'ForeName': 'G I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA. gpapakostas@partners.org.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Johe', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hand', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Drouillard', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Russo', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kay', 'Affiliation': 'Cognitive Research Corp., Saint Petersburg, Florida, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kashambwa', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Martinson', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0334-8']
602,31931250,Effect of Dexmedetomidine with Different Anesthetic Dosage on Neurocognitive Function in Elderly Patients After Operation Based on Neural Network Model.,"This paper uses a neural network model to study the protective effect of dexmedetomidine on the anesthesia recovery period and neurocognitive function in elderly patients undergoing radical resection of colorectal cancer. Eighty-eight patients with colorectal cancer who underwent radical surgery in our hospital from January 2015 to June 2017 were randomly divided into groups: study (43 cases) and control (45 cases). The study group was treated with dexmedetomidine for anesthesia. Patients in the study group were given a slow pumping dose of 1 μg/kg to prepare dexmedetomidine at a dose of 1 μg/kg. The pumping time was >10 minutes, and the dose was 0.3 μg after completion. The loading dose of 0.3 (kg·h) was maintained intraoperatively; the control group was given the same amount of saline infusion by the same infusion method. The study found that the probability of cognitive dysfunction in the study group was significantly lower than that in the control group, and the degree of cognitive dysfunction in the study group was significantly lower than that in the control group (P < 0.05). Therefore in the operation of elderly patients with colorectal cancer radical surgery, dexmedetomidine is used for anesthesia to protect postoperative cognitive function and reduce the incidence of cognitive dysfunction. Extensive promotion and application in the clinic.",2020,"The study found that the probability of cognitive dysfunction in the study group was significantly lower than that in the control group, and the degree of cognitive dysfunction in the study group was significantly lower than that in the control group (P<0.05).","['elderly patients after operation based on neural network model', 'Eighty-eight patients with colorectal cancer who underwent radical surgery in our hospital from January 2015 to June 2017', 'elderly patients with colorectal cancer radical surgery', 'elderly patients undergoing radical resection of colorectal cancer']","['dexmedetomidine', 'slow pumping dose of 1 μg/kg to prepare dexmedetomidine']","['neurocognitive function', 'degree of cognitive dysfunction', 'probability of cognitive dysfunction', 'pumping time']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0870951', 'cui_str': 'Connectionist Models'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",2017.0,0.0161078,"The study found that the probability of cognitive dysfunction in the study group was significantly lower than that in the control group, and the degree of cognitive dysfunction in the study group was significantly lower than that in the control group (P<0.05).","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, The Fifth Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China. Electronic address: chenhongyishengys@163.com.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The Fifth Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang, China.'}]",World neurosurgery,['10.1016/j.wneu.2020.01.012']
603,31279028,"Crisaborole 2% ointment for the treatment of intertriginous, anogenital, and facial psoriasis: A double-blind, randomized, vehicle-controlled trial.","BACKGROUND


Psoriasis of the intertriginous, anogenital, and facial regions remains a therapeutic challenge, with current algorithms lacking a topical agent that exhibits both high efficacy and minimal side effects.
OBJECTIVE


To assess the safety and efficacy of crisaborole 2% ointment-a nonsteroidal phosphodiesterase 4 inhibitor-in the treatment of intertriginous, anogenital, and facial psoriasis.
METHODS


A double-blind, randomized, vehicle-controlled trial was conducted in 21 participants. Participants were randomized 2:1 to receive 4 weeks of twice-daily treatment with either crisaborole 2% ointment (n = 14) or vehicle ointment (n = 7), followed by 4 weeks of open-label treatment with crisaborole 2% ointment. Disease severity was measured by using the Target Lesion Severity Scale (TLSS).
RESULTS


After 4 weeks, participants in the crisaborole group demonstrated 66% improvement compared with 9% in the vehicle group (P = .0011). Participants in the crisaborole group continued to experience improvement through the open-label phase, demonstrating 81% lesional improvement by week 8, with 71% of these participants achieving clinical clearance. There were no adverse events.
LIMITATIONS


The study was limited to a single tertiary care center and small sample size.
CONCLUSION


Treatment with crisaborole 2% ointment was well-tolerated and led to clinical improvement in participants with intertriginous, anogenital, or facial psoriasis.",2020,"After 4 weeks, subjects in the crisaborole group demonstrated 66% improvement compared to 9% in the vehicle group (p=0.0011).","['21 subjects', 'subjects with intertriginous, anogenital, or facial psoriasis']","['crisaborole 2% ointment', 'crisaborole 2% ointment (n=14) or vehicle ointment', 'Crisaborole 2% ointment', 'crisaborole 2% ointment-a nonsteroidal, phosphodiesterase-4 inhibitor']","['Disease severity', 'safety and efficacy', 'tolerated', 'clinical clearance', 'Target Lesion Severity Scale (TLSS', 'intertriginous, anogenital, and facial psoriasis']","[{'cui': 'C0205268', 'cui_str': 'Intertriginous (qualifier value)'}, {'cui': 'C1276112', 'cui_str': 'Psoriasis of face'}]","[{'cui': 'C4301781', 'cui_str': 'crisaborole'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C2936609', 'cui_str': 'Phosphodiesterase Type 4 Inhibitors'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0222045'}, {'cui': 'C0205268', 'cui_str': 'Intertriginous (qualifier value)'}, {'cui': 'C1276112', 'cui_str': 'Psoriasis of face'}]",,0.220782,"After 4 weeks, subjects in the crisaborole group demonstrated 66% improvement compared to 9% in the vehicle group (p=0.0011).","[{'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Hashim', 'Affiliation': 'Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'Chima', 'Affiliation': 'Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Hee J', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Bares', 'Affiliation': 'Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Yao', 'Affiliation': 'Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Singer', 'Affiliation': 'Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Tinley', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Genece', 'Affiliation': 'Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Baum', 'Affiliation': 'Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Grace W', 'Initials': 'GW', 'LastName': 'Kimmel', 'Affiliation': 'Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Nia', 'Affiliation': 'Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Gagliotti', 'Affiliation': 'Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Lebwohl', 'Affiliation': 'Department of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: mark.lebwohl@mountsinai.org.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.06.1288']
604,31512815,Coenzyme Q10 Upregulates Platelet cAMP/PKA Pathway and Attenuates Integrin αIIbβ3 Signaling and Thrombus Growth.,"SCOPE


Platelet integrin αIIbβ3 is the key mediator of atherothrombosis. Supplementation of coenzyme Q10 (CoQ10), a fat-soluble molecule that exists in various foods, exerts protective cardiovascular effects. This study aims to investigate whether and how CoQ10 acts on αIIbβ3 signaling and thrombosis, the major cause of cardiovascular diseases.
METHODS AND RESULTS


Using a series of platelet functional assays in vitro, it is demonstrated that CoQ10 reduces human platelet aggregation, granule secretion, platelet spreading, and clot retraction. It is further demonstrated that CoQ10 inhibits platelet integrin αIIbβ3 outside-in signaling. These inhibitory effects are mainly mediated by upregulating cAMP/PKA pathway, where CoQ10 stimulates the A 2A  adenosine receptor and decreases phosphodiesterase 3A phosphorylation. Moreover, CoQ10 attenuates murine thrombus growth and vessel occlusion in a ferric chloride (FeCl 3  )-induced thrombosis model in vivo. Importantly, the randomized, double-blind, placebo-controlled clinical trial in dyslipidemic patients demonstrates that 24 weeks of CoQ10 supplementation increases platelet CoQ10 concentrations, enhances the cAMP/PKA pathway, and attenuates αIIbβ3 outside-in signaling, leading to decreased platelet aggregation and granule release.
CONCLUSION


Through upregulating the platelet cAMP/PKA pathway, and attenuating αIIbβ3 signaling and thrombus growth, CoQ10 supplementation may play an important protective role in patients with risks of cardiovascular diseases.",2019,"These inhibitory effects are mainly mediated by upregulating cAMP/PKA pathway, where CoQ10 stimulates the A 2A  adenosine receptor and decreases phosphodiesterase 3A phosphorylation.","['dyslipidemic patients', 'patients with risks of cardiovascular diseases']","['CoQ10', 'CoQ10 supplementation', 'placebo', 'ferric chloride (FeCl 3  ', 'coenzyme Q10 (CoQ10']",['platelet CoQ10 concentrations'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]","[{'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0060229', 'cui_str': 'ferric chloride'}, {'cui': 'C0963456', 'cui_str': 'Fe(TMP)Cl'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0056077', 'cui_str': 'coenzyme Q10'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0553714,"These inhibitory effects are mainly mediated by upregulating cAMP/PKA pathway, where CoQ10 stimulates the A 2A  adenosine receptor and decreases phosphodiesterase 3A phosphorylation.","[{'ForeName': 'Fuli', 'Initials': 'F', 'LastName': 'Ya', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University (Northern Campus), Guangzhou, Guangdong Province, 510080, China.'}, {'ForeName': 'Xiaohong Ruby', 'Initials': 'XR', 'LastName': 'Xu', 'Affiliation': ""Department of Laboratory Medicine, Keenan Research Centre for Biomedical Science, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, M5B 1W8, Canada.""}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University (Northern Campus), Guangzhou, Guangdong Province, 510080, China.'}, {'ForeName': 'Reid C', 'Initials': 'RC', 'LastName': 'Gallant', 'Affiliation': ""Department of Laboratory Medicine, Keenan Research Centre for Biomedical Science, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, M5B 1W8, Canada.""}, {'ForeName': 'Fenglin', 'Initials': 'F', 'LastName': 'Song', 'Affiliation': 'School of Food Science, Guangdong Pharmaceutical University, Guangzhou, Guangdong Province, 510006, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': 'Guangdong Provincial Key Laboratory for Food, Nutrition and Health, Guangzhou, Guangdong Province, 510080, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Guangdong Provincial Key Laboratory for Food, Nutrition and Health, Guangzhou, Guangdong Province, 510080, China.'}, {'ForeName': 'Zezhong', 'Initials': 'Z', 'LastName': 'Tian', 'Affiliation': 'Guangdong Provincial Key Laboratory for Food, Nutrition and Health, Guangzhou, Guangdong Province, 510080, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Laboratory, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong Province, 510120, China.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'National Clinical Research Center for Kidney Disease, Renal Division, Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong Province, 510515, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Ling', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University (Northern Campus), Guangzhou, Guangdong Province, 510080, China.'}, {'ForeName': 'Heyu', 'Initials': 'H', 'LastName': 'Ni', 'Affiliation': ""Department of Laboratory Medicine, Keenan Research Centre for Biomedical Science, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, M5B 1W8, Canada.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Guangdong Provincial Key Laboratory for Food, Nutrition and Health, Guangzhou, Guangdong Province, 510080, China.'}]",Molecular nutrition & food research,['10.1002/mnfr.201900662']
605,31906766,Do patients with PD benefit from music assisted therapy plus treadmill-based gait training? An exploratory study focused on behavioral outcomes.,"Purpose:  Parkinson's disease (PD) is the second most common age-related neurodegenerative disorder, presenting not only with motor symptoms (resting tremor, bradykinesia, and muscular rigidity), but also with cognitive and behavioral problems that need to be addressed in a rehabilitation setting. Aim of the study was to evaluate the effects of a combined rehabilitative approach, using gait training coupled to music-based therapy, on cognitive and behavioral function in a sample of patients with PD. Materials and Methods:  Forty patients, meeting the inclusion criteria, were enrolled in this study and were randomly divided into two groups. The control group (CG) underwent traditional over ground gait training, whilst the experimental group (EG) underwent gait training with the Biodex Gait Trainer 3 (a treadmill integrated with music therapy). Each subject was evaluated at baseline (T0) and after the training (T1), using specific neuropsychological and motor function tests. Results:  The EG presented higher outcomes scores concerning mood and quality of life in all subscales of Psychological General Well-Being Index (i.e. anxiety, depression, health, vitality and positivity) and subscales of Brief-COPE, with regard to behavioral disengagement, positive reframing, planning, acceptance and use of emotional support, as compared to the CG. Moreover, a significant improvement in motor functioning, with regard to static and dynamic balance, was found in the EG. Conclusion:  Music-based gait training rehabilitation may be considered an effective strategy to improve behavioral performances, coping strategies and rehabilitation outcomes in patients with PD.",2020,"The EG presented higher outcomes scores concerning mood and quality of life in all subscales of Psychological General Well-Being Index (i.e. anxiety, depression, health, vitality and positivity) and subscales of Brief-COPE, with regard to behavioral disengagement, positive reframing, planning, acceptance and use of emotional support, as compared to the CG.","['Forty patients, meeting the inclusion criteria', 'patients with PD']","['gait training coupled to music-based therapy', 'Music-based gait training rehabilitation', 'music assisted therapy plus treadmill-based gait training', 'control group (CG) underwent traditional over ground gait training, whilst the experimental group (EG) underwent gait training with the Biodex Gait Trainer 3 (a treadmill integrated with music therapy', 'combined rehabilitative approach']","['motor functioning', 'mood and quality of life in all subscales of Psychological General Well-Being Index (i.e. anxiety, depression, health, vitality and positivity) and subscales of Brief-COPE, with regard to behavioral disengagement, positive reframing, planning, acceptance and use of emotional support', 'static and dynamic balance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0026868', 'cui_str': 'Music Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0034380'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C2939150', 'cui_str': 'General wellbeing (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0600015', 'cui_str': 'Emotional support (regime/therapy)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",40.0,0.0168402,"The EG presented higher outcomes scores concerning mood and quality of life in all subscales of Psychological General Well-Being Index (i.e. anxiety, depression, health, vitality and positivity) and subscales of Brief-COPE, with regard to behavioral disengagement, positive reframing, planning, acceptance and use of emotional support, as compared to the CG.","[{'ForeName': 'Rosaria', 'Initials': 'R', 'LastName': 'De Luca', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Latella', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Maggio', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Leonardi', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Sorbera', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Di Lorenzo', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Balletta', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cannavò', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Naro', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Impellizzeri', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy.'}, {'ForeName': 'Rocco Salvatore', 'Initials': 'RS', 'LastName': 'Calabrò', 'Affiliation': 'IRCCS Centro Neurolesi ""Bonino Pulejo"", Messina, Italy.'}]",The International journal of neuroscience,['10.1080/00207454.2019.1710147']
606,31908976,Six month durability of targeted cognitive training supplemented with social cognition exercises in schizophrenia.,"Background


Deficits in cognition, social cognition, and motivation are significant predictors of poor functional outcomes in schizophrenia. Evidence of durable benefit following social cognitive training is limited. We previously reported the effects of 70 h of targeted cognitive training supplemented with social cognitive exercises (TCT + SCT) verses targeted cognitive training alone (TCT). Here, we report the effects six months after training.
Methods


111 participants with schizophrenia spectrum disorders were randomly assigned to TCT + SCT or TCT-only. Six months after training, thirty-four subjects (18 TCT + SCT, 16 TCT-only) were assessed on cognition, social cognition, reward processing, symptoms, and functioning. Intent to treat analyses was used to test the durability of gains, and the association of gains with improvements in functioning and reward processing were tested.
Results


Both groups showed durable improvements in multiple cognitive domains, symptoms, and functional capacity. Gains in global cognition were significantly associated with gains in functional capacity. In the TCT + SCT group, participants showed durable improvements in prosody identification and reward processing, relative to the TCT-only group. Gains in reward processing in the TCT + SCT group were significantly associated with improvements in social functioning.
Conclusions


Both TCT + SCT and TCT-only result in durable improvements in cognition, symptoms, and functional capacity six months post-intervention. Supplementing TCT with social cognitive training offers greater and enduring benefits in prosody identification and reward processing. These results suggest that novel cognitive training approaches that integrate social cognitive exercises may lead to greater improvements in reward processing and functioning in individuals with schizophrenia.",2020,"In the TCT + SCT group, participants showed durable improvements in prosody identification and reward processing, relative to the TCT-only group.","['individuals with schizophrenia', 'schizophrenia', '111 participants with schizophrenia spectrum disorders']","['Supplementing TCT with social cognitive training', 'TCT\xa0+\xa0SCT', 'cognitive training supplemented with social cognitive exercises (TCT\xa0+\xa0SCT) verses targeted cognitive training alone (TCT', 'social cognitive training', 'TCT\xa0+\xa0SCT or TCT-only', 'targeted cognitive training supplemented with social cognition exercises']","['Gains in reward processing', 'multiple cognitive domains, symptoms, and functional capacity', 'cognition, symptoms, and functional capacity', 'social functioning', 'cognition, social cognition, reward processing, symptoms, and functioning', 'global cognition', 'reward processing and functioning', 'prosody identification and reward processing']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0677634', 'cui_str': 'Reptilase Time'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0042553', 'cui_str': 'Versed'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0233743', 'cui_str': 'Prosody, function (observable entity)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}]",111.0,0.0140403,"In the TCT + SCT group, participants showed durable improvements in prosody identification and reward processing, relative to the TCT-only group.","[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Miley', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota, F282/2A West, 2450 Riverside Avenue, Minneapolis, MN 55454, United States of America.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota, F282/2A West, 2450 Riverside Avenue, Minneapolis, MN 55454, United States of America.'}, {'ForeName': 'Mor', 'Initials': 'M', 'LastName': 'Nahum', 'Affiliation': 'School of Occupational Therapy, Faculty of Medicine, Hebrew University, PO Box 24026, Mount Scopus, Jerusalem, 94210, Israel.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Howard', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, 401 Parnassus Ave., San Francisco, CA 94143, United States of America.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Rowlands', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, 401 Parnassus Ave., San Francisco, CA 94143, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Brandrett', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, 401 Parnassus Ave., San Francisco, CA 94143, United States of America.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Woolley', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, 401 Parnassus Ave., San Francisco, CA 94143, United States of America.'}, {'ForeName': 'Christine I', 'Initials': 'CI', 'LastName': 'Hooker', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, 1645 W. Jackson Blvd., Suite 400, Chicago, IL, United States of America.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Biagianti', 'Affiliation': 'Posit Science, Inc., 160 Pine St., Suite 200, San Francisco, CA 94111, United States of America.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ramsay', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota, F282/2A West, 2450 Riverside Avenue, Minneapolis, MN 55454, United States of America.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota, F282/2A West, 2450 Riverside Avenue, Minneapolis, MN 55454, United States of America.'}]",Schizophrenia research. Cognition,['10.1016/j.scog.2019.100171']
607,31912485,Preventive intervention for trauma reactions in young injured children: results of a multi-site randomised controlled trial.,"BACKGROUND


Young children are at particular risk for injury. Ten per cent to twenty-five per cent develop posttraumatic stress disorder (PTSD). However, no empirically supported preventive interventions exist. Therefore, this study evaluated the efficacy of a standardised targeted preventive intervention for PTSD in young injured children.
METHODS


Injured children (1-6 years) were enrolled in a multi-site parallel-group superiority prospective randomised controlled trial (RCT) in Australia and Switzerland. Screening for PTSD risk occurred 6-8 days postaccident. Parents of children who screened 'high-risk' were randomised to a 2-session CBT-based intervention or treatment-as-usual (TAU). Primary outcomes were PTSD symptom (PTSS) severity, and secondary outcomes were PTSD diagnosis, functional impairment and behavioural difficulties at 3 and 6 months postinjury using blinded assessments. Trials were registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000325606) and ClinicalTrials.gov (NCT02088814). Trial status is complete.
RESULTS


One hundred and thirty-three children screened 'high-risk' were assigned to intervention (n = 62) or TAU (n = 71). Multilevel intention-to-treat analyses revealed a significant intervention effect on PTSS severity over time (b = 60.06, 95% CI: 21.30-98.56). At 3 months, intervention children (M = 11.02, SD = 10.42, range 0-47) showed an accelerated reduction in PTSS severity scores compared to control children (M = 17.30, SD = 13.94, range 0-52; mean difference -6.97, 95% CI: -14.02 to 0.08, p adj. = .055, d = 0.51). On secondary outcomes, multilevel analyses revealed significant treatment effects for PTSD diagnosis, functional impairment and behavioural difficulties.
CONCLUSIONS


This multi-site RCT provides promising preliminary evidence for the efficacy of a targeted preventive intervention for accelerating recovery from PTSS in young injured children. This has important clinical implications for the psychological support provided to young children and parents during the acute period following a single-event trauma.",2020,Parents of children who screened 'high-risk' were randomised to a 2-session CBT-based intervention or treatment-as-usual (TAU).,"[""Parents of children who screened 'high-risk"", ""One hundred and thirty-three children screened 'high-risk"", 'young injured children', 'Injured children (1-6\xa0years', 'Young children']","['standardised targeted preventive intervention', 'Preventive intervention', 'TAU', '2-session CBT-based intervention or treatment-as-usual (TAU']","['PTSD risk', 'PTSS severity scores', 'PTSS severity over time', 'PTSD symptom (PTSS) severity, and secondary outcomes were PTSD diagnosis, functional impairment and behavioural difficulties', 'PTSD diagnosis, functional impairment and behavioural difficulties']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",133.0,0.224064,Parents of children who screened 'high-risk' were randomised to a 2-session CBT-based intervention or treatment-as-usual (TAU).,"[{'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Haag', 'Affiliation': ""Department of Psychosomatics and Psychiatry, and Children's Research Centre, University Children's Hospital Zurich, Zurich, Switzerland.""}, {'ForeName': 'Markus A', 'Initials': 'MA', 'LastName': 'Landolt', 'Affiliation': ""Department of Psychosomatics and Psychiatry, and Children's Research Centre, University Children's Hospital Zurich, Zurich, Switzerland.""}, {'ForeName': 'Justin A', 'Initials': 'JA', 'LastName': 'Kenardy', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Clemens M', 'Initials': 'CM', 'LastName': 'Schiestl', 'Affiliation': ""Division of Plastic Surgery, University Children's Hospital Zurich, Zurich, Switzerland.""}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Kimble', 'Affiliation': ""Centre for Children's Burns and Trauma Research, Centre for Child Health Research, University of Queensland, Brisbane, QLD, Australia.""}, {'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'De Young', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, QLD, Australia.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13193']
608,30833204,Utilizing Intraprocedural Interactive Video Capture With Google Glass for Immediate Postprocedural Resident Coaching.,"BACKGROUND


Video coaching has been found to be an effective teaching method because it incorporates many of the established principles of successful adult learning. The goal of our study was to assess the feasibility and effectiveness of using a point-of-view video camera (Google Glass) to improve the surgical skills education of orthopaedic surgery residents.
METHODS


Forty-two residents from 4 institutions participated in a partially blinded randomized control trial performing an intra-articular distal tibial fracture reduction task while wearing Google Glass to record the performance. Participants underwent a structured coaching session with 20 participants (intervention group) using the recorded video to augment this session, and 22 participants (control group) receiving verbal coaching alone. The task was repeated again immediately after the coaching session. Performance was scored using an Objective Structured Assessment of Technical Skills checklist, Global Rating Scale, fluoroscopic usage, and reduction quality. A semistructured interview was then performed to assess experience of participants.
RESULTS


There was no significant difference (p > 0.05) seen in score improvement in the Objective Structured Assessment of Technical Skills checklist, Global Rating Scale, fluoroscopic usage, or reduction quality between the control and intervention groups. Thematic analysis of interview showed majority of participants found video coaching increased effectiveness in understanding of goals, developing techniques and strategies, and process of self-reflection. Their involvement was seen overall as a positive experience, with participants wanting to see more inclusion of video coaching within surgical education.
CONCLUSIONS


No difference in performance improvement between the 2 groups was seen, but majority of participants found the video coaching sessions valuable and could have potential beneficial role in education.",2019,"There was no significant difference (p > 0.05) seen in score improvement in the Objective Structured Assessment of Technical Skills checklist, Global Rating Scale, fluoroscopic usage, or reduction quality between the control and intervention groups.","['Forty-two residents from 4 institutions participated', 'orthopaedic surgery residents']","['structured coaching session with 20 participants (intervention group) using the recorded video to augment this session, and 22 participants (control group) receiving verbal coaching alone', 'point-of-view video camera (Google Glass', 'intra-articular distal tibial fracture reduction task while wearing Google Glass']","['Technical Skills checklist, Global Rating Scale, fluoroscopic usage, and reduction quality', 'Technical Skills checklist, Global Rating Scale, fluoroscopic usage, or reduction quality', 'performance improvement', 'feasibility and effectiveness']","[{'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0179533', 'cui_str': 'Camera'}, {'cui': 'C0017596', 'cui_str': 'Glass'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0040185', 'cui_str': 'Tibial Fractures'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",42.0,0.0375559,"There was no significant difference (p > 0.05) seen in score improvement in the Objective Structured Assessment of Technical Skills checklist, Global Rating Scale, fluoroscopic usage, or reduction quality between the control and intervention groups.","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dickerson', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire. Electronic address: patdickerson@gmail.com.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Grande', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Evans', 'Affiliation': 'Loyola University Chicago, Chicago, Illinois.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Levine', 'Affiliation': 'Rush University, Chicago, Illinois.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Coe', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.'}]",Journal of surgical education,['10.1016/j.jsurg.2018.10.002']
609,31918720,Effects of carbohydrate supplementation on aerobic exercise performance during acute high altitude exposure and after 22 days of acclimatization and energy deficit.,"BACKGROUND


The ergogenic effects of supplemental carbohydrate on aerobic exercise performance at high altitude (HA) may be modulated by acclimatization status. Longitudinal evaluation of potential performance benefits of carbohydrate supplementation in the same volunteers before and after acclimatization to HA have not been reported.
PURPOSE


This study examined how consuming carbohydrate affected 2-mile time trial performance in lowlanders at HA (4300 m) before and after acclimatization.
METHODS


Fourteen unacclimatized men performed 80 min of metabolically-matched (~ 1.7 L/min) treadmill walking at sea level (SL), after ~ 5 h of acute HA exposure, and after 22 days of HA acclimatization and concomitant 40% energy deficit (chronic HA). Before, and every 20 min during walking, participants consumed either carbohydrate (CHO, n = 8; 65.25 g fructose + 79.75 g glucose, 1.8 g carbohydrate/min) or flavor-matched placebo (PLA, n = 6) beverages. A self-paced 2-mile treadmill time trial was performed immediately after completing the 80-min walk.
RESULTS


There were no differences (P > 0.05) in time trial duration between CHO and PLA at SL, acute HA, or chronic HA. Time trial duration was longer (P < 0.05) at acute HA (mean ± SD; 27.3 ± 6.3 min) compared to chronic HA (23.6 ± 4.5 min) and SL (17.6 ± 3.6 min); however, time trial duration at chronic HA was still longer than SL (P < 0.05).
CONCLUSION


These data suggest that carbohydrate supplementation does not enhance aerobic exercise performance in lowlanders acutely exposed or acclimatized to HA.
TRIAL REGISTRATION


NCT, NCT02731066, Registered March 292,016.",2020,"There were no differences (P > 0.05) in time trial duration between CHO and PLA at SL, acute HA, or chronic HA.","['acute high altitude exposure and after 22\u2009days of acclimatization and energy deficit', 'lowlanders acutely exposed or acclimatized to HA', 'Fourteen unacclimatized men performed', 'lowlanders at HA (4300\u2009m) before and after acclimatization']","['carbohydrate (CHO, n\u2009=\u20098; 65.25\u2009g fructose +\u200979.75\u2009g glucose, 1.8\u2009g carbohydrate/min) or flavor-matched placebo (PLA, n\u2009=\u20096) beverages', 'carbohydrate supplementation', '80\u2009min of metabolically-matched (~\u20091.7\u2009L/min) treadmill walking at sea level (SL), after ~\u20095\u2009h of acute HA exposure, and after 22\u2009days of HA acclimatization and concomitant 40% energy deficit (chronic HA', 'supplemental carbohydrate']","['time trial duration at chronic HA', 'Time trial duration', 'aerobic exercise performance']","[{'cui': 'C0238617', 'cui_str': 'High altitude (physical force)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0391940', 'cui_str': 'Fructose measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C3538953', 'cui_str': 'Carbohydrate supplementation'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]",,0.100917,"There were no differences (P > 0.05) in time trial duration between CHO and PLA at SL, acute HA, or chronic HA.","[{'ForeName': 'Karleigh E', 'Initials': 'KE', 'LastName': 'Bradbury', 'Affiliation': 'Thermal and Mountain Medicine Division, US Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Bldg, Natick, MA, 42, USA.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Berryman', 'Affiliation': 'Military Nutrition Division, US Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Bldg, Natick, MA, 42, USA.'}, {'ForeName': 'Marques A', 'Initials': 'MA', 'LastName': 'Wilson', 'Affiliation': 'Military Nutrition Division, US Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Bldg, Natick, MA, 42, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Luippold', 'Affiliation': 'Thermal and Mountain Medicine Division, US Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Bldg, Natick, MA, 42, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Kenefick', 'Affiliation': 'Thermal and Mountain Medicine Division, US Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Bldg, Natick, MA, 42, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Young', 'Affiliation': 'Military Nutrition Division, US Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Bldg, Natick, MA, 42, USA.'}, {'ForeName': 'Stefan M', 'Initials': 'SM', 'LastName': 'Pasiakos', 'Affiliation': 'Military Nutrition Division, US Army Research Institute of Environmental Medicine, 10 General Greene Avenue, Bldg, Natick, MA, 42, USA. Stefan.m.pasiakos.civ@mail.mil.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-0335-2']
610,31934821,Nattospes as Effective and Safe Functional Supplements in Management of Stroke.,"Stroke remains a major cause of human disability worldwide. Interventions and rehabilitation at the poststroke stage are critical for recovery. A single-blinded randomized controlled trial was conducted on 61 patients diagnosed with subacute stage of ischemic stroke. Ingestion of Nattospecs was tested as an adjuvant to support rehabilitation when combined with standard of care (SOC) treatment (electroacupuncture and Naatrapyl) (Trial group) and compared to SOC treatment alone (Control group). After 60 days, results showed that both Trial and Control groups achieved significant improvements in physical activities, blood pressure control, serum lipid panels, and quality of life. Nattospes as a food supplement has good supportive effects on treatment and rehabilitation after ischemic stroke by showing statistically significant improvement of stroke-related symptom in scores from modified Rankin, Orgogozo, and Barthel scales. In addition, Nattospes showed a good safety profile, with no adverse effects reported in both clinical and paraclinical parameters. This study indicated that Nattospes as nutraceutical supplement can be applied safely and effectively in the management of subacute stage ischemic stroke. The findings of the study may also encourage further extensive clinical trials to fully explore the prospect of Nattospes as a nutraceutical adjunct in the management of cardiovascular disease.",2020,"After 60 days, results showed that both Trial and Control groups achieved significant improvements in physical activities, blood pressure control, serum lipid panels, and quality of life.",['61 patients diagnosed with subacute stage of ischemic stroke'],"['standard of care (SOC) treatment (electroacupuncture and Naatrapyl', 'SOC treatment alone (Control group']","['physical activities, blood pressure control, serum lipid panels, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]","[{'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0200382', 'cui_str': 'Lipid panel (procedure)'}, {'cui': 'C0034380'}]",,0.0568047,"After 60 days, results showed that both Trial and Control groups achieved significant improvements in physical activities, blood pressure control, serum lipid panels, and quality of life.","[{'ForeName': 'Phuong T', 'Initials': 'PT', 'LastName': 'Pham', 'Affiliation': 'Tue Tinh Hospital-Vietnamese Academy of Traditional Medicine, Hanoi, Vietnam.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Han', 'Affiliation': 'Nimni-Cordoba Tissue Engineering and Drug Discovery Laboratory, Division of Plastic and Reconstructive Surgery, Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Ba X', 'Initials': 'BX', 'LastName': 'Hoang', 'Affiliation': 'Nimni-Cordoba Tissue Engineering and Drug Discovery Laboratory, Division of Plastic and Reconstructive Surgery, Department of Surgery, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}]",Journal of medicinal food,['10.1089/jmf.2019.0183']
611,31571339,Combined pulsed and thermal radiofrequency versus thermal radiofrequency alone in the treatment of recurrent trigeminal neuralgia after microvascular decompression: A double blinded comparative study.,"BACKGROUND


Recurrent trigeminal neuralgia (RTN) is a common clinical problem and pain recurs in many patients after microvascular decompression (MVD). We evaluated the effect of adding pulsed radiofrequency to radiofrequency thermocoagulation at 60°C compared to radiofrequency thermocoagulation at 70°C alone in the treatment of recurrent trigeminal neuralgia after microvascular decompression.
METHODS


40 patients with recurrent trigeminal neuralgia after microvascular decompression were randomly divided into two equal groups. Group A: received prolonged duration of pulsed radiofrequency followed by less destructive thermocoagulation, while group B: received sole thermocoagulation. Then patients followed up for 2 years to evaluate the success rate by the Barrow Neurological Institute Pain Intensity (BNI) Scale, complications, and the need to medical treatment.
RESULTS


The success rate was 100% in both groups at discharge (BNI < III). It was 83.3% and 78.7% after 6 months, 77.8% and 68.4% after 12 month, 72.2% and 68.4% after 18 months and 66.7% and 63.1% after 24 months in group A and B, respectively (p > .05). In group A 88.9% of patients stopped tegretol treatment after the procedure compared to 84.2% in group B (p = .32). 88.9% compared to 89.5% % in group A and B, respectively, did not use tricyclic antidepressant (p = .61). The overall complications in group A was 5.61%, while it was 36.8% in group B (p = .025).
CONCLUSION


Combined pulsed and thermal radiofrequency can significantly reduce the incidence of the side effects/complications with similar success rate than using thermal radiofrequency alone in treatment of recurrent trigeminal neuralgia after microvascular decompression.",2020,In group A 88.9% of patients stopped tegretol treatment after the procedure compared to 84.2% in group B (p=0.32).,"['recurrent trigeminal neuralgia after microvascular decompression', '40 patients with recurrent trigeminal neuralgia after microvascular decompression', 'patients after microvascular decompression (MVD']","['Combined pulsed and thermal radiofrequency', 'radiofrequency thermocoagulation at 70 ºC alone', 'thermal radiofrequency alone', 'Combined pulsed and thermal radiofrequency versus thermal radiofrequency alone', 'pulsed radiofrequency to radiofrequency thermocoagulation', 'prolonged duration of pulsed radiofrequency followed by less destructive thermocoagulation, while group B: received sole thermocoagulation']","['success rate by the Barrow Neurological Institute Pain Intensity (BNI) Scale, complications, and the need to medical treatment', 'success rate', 'overall complications']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0040997', 'cui_str': 'Fothergill Disease'}, {'cui': 'C1328580', 'cui_str': 'Microvascular Decompression'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0013804', 'cui_str': 'Surgical Diathermy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0233520', 'cui_str': 'Destructive behavior (finding)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0222045'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",40.0,0.0184994,In group A 88.9% of patients stopped tegretol treatment after the procedure compared to 84.2% in group B (p=0.32).,"[{'ForeName': 'Khaled A', 'Initials': 'KA', 'LastName': 'Abdel-Rahman', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Abdelraheem M', 'Initials': 'AM', 'LastName': 'Elawamy', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed F', 'Initials': 'MF', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Waleed S', 'Initials': 'WS', 'LastName': 'Hasan', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ragaa', 'Initials': 'R', 'LastName': 'Herdan', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Nagwa M', 'Initials': 'NM', 'LastName': 'Osman', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Abdelrady S', 'Initials': 'AS', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Mohamed G', 'Initials': 'MG', 'LastName': 'Aly', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Abdelhady S', 'Initials': 'AS', 'LastName': 'Ali', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Gamal M', 'Initials': 'GM', 'LastName': 'Abodahab', 'Affiliation': 'Department of Anesthesia, Intensive Care and Pain Management, Faculty of Medicine, Qena University, Qena, Egypt.'}]","European journal of pain (London, England)",['10.1002/ejp.1489']
612,31900166,Effects of caffeine supplementation on physical performance and mood dimensions in elite and trained-recreational athletes.,"BACKGROUND


Caffeine supplementation (CAFF) has an established ergogenic effect on physical performance and the psychological response to exercise. However, few studies have compared the response to CAFF intake among athletes of different competition level. This study compares the acute effects of CAFF on anaerobic performance, mood and perceived effort in elite and moderately-trained recreational athletes.
METHODS


Participants for this randomized, controlled, crossover study were 8 elite athletes (in the senior boxing national team) and 10 trained-recreational athletes. Under two experimental conditions, CAFF supplementation (6 mg/kg) or placebo (PLAC), the athletes completed a Wingate test. Subjective exertion during the test was recorded as the rating of perceived exertion (RPE) both at the general level (RPE general ) and at the levels muscular (RPE muscular ) and cardiorespiratory (RPE cardio ). Before the Wingate test, participants completed the questionnaires Profiles of Moods States (POMS) and Subjective Vitality Scale (SVS).
RESULTS


In response to CAFF intake, improvements were noted in W peak  (11.22 ± 0.65 vs 10.70 ± 0.84; p = 0.003; [Formula: see text] =0.44), W avg  (8.75 ± 0.55 vs 8.41 0.46; p = 0.001; [Formula: see text] =0.53) and time taken to reach W peak  (7.56 ± 1.58 vs 9.11 ± 1.53; p <  0.001; [Formula: see text] =0.57) both in the elite and trained-recreational athletes. However, only the elite athletes showed significant increases in tension (+ 325%), vigor (+ 31%) and SVS (+ 28%) scores after the intake of CAFF compared to levels recorded under the condition PLAC (p <  0.05). Similarly, levels of vigor after consuming CAFF were significantly higher in the elite than the trained-recreational athletes (+ 5.8%).
CONCLUSIONS


CAFF supplementation improved anaerobic performance in both the elite and recreational athletes. However, the ergogenic effect of CAFF on several mood dimensions and subjective vitality was greater in the elite athletes.",2020,"However, the ergogenic effect of CAFF on several mood dimensions and subjective vitality was greater in the elite athletes.","['elite athletes', 'elite and trained-recreational athletes', 'elite and moderately-trained recreational athletes', 'elite and recreational athletes', '8 elite athletes (in the senior boxing national team) and 10 trained-recreational athletes']","['Caffeine supplementation (CAFF', 'CAFF', 'placebo (PLAC', 'CAFF supplementation', 'caffeine supplementation']","['questionnaires Profiles of Moods States (POMS) and Subjective Vitality Scale (SVS', 'anaerobic performance, mood and perceived effort', 'SVS', 'levels muscular (RPE muscular ) and cardiorespiratory (RPE cardio ', 'tension', 'levels of vigor after consuming CAFF', 'anaerobic performance', 'several mood dimensions and subjective vitality', 'physical performance and mood dimensions', 'Subjective exertion']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0048838', 'cui_str': 'PLAC'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0222045'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C2607857'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}]",,0.0711324,"However, the ergogenic effect of CAFF on several mood dimensions and subjective vitality was greater in the elite athletes.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Jodra', 'Affiliation': 'Faculty of Health Sciences, Universidad Alfonso X El Sabio, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lago-Rodríguez', 'Affiliation': 'Faculty of Health Sciences, Universidad Isabel I, Burgos, Spain. angel.lago@ui1.es.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Sánchez-Oliver', 'Affiliation': 'Department of Human Motricity and Sports Performance, Faculty of Education Sciences, Seville University, Seville, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'López-Samanes', 'Affiliation': 'School of Physiotherapy, Faculty of Health Sciences, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pérez-López', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Medicine and Health Sciences, University of Alcalá, Madrid, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Veiga-Herreros', 'Affiliation': 'Faculty of Health Sciences, Universidad Alfonso X El Sabio, Madrid, Spain.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'San Juan', 'Affiliation': 'Sports Biomechanics Laboratory, Department of Health and Human Performance, Faculty of Physical Activity and Sport Sciences - INEF, Universidad Politécnica de Madrid, Madrid, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Domínguez', 'Affiliation': 'Faculty of Health Sciences, Universidad Isabel I, Burgos, Spain.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-019-0332-5']
613,31897708,Evaluation of efficacy of non-thermal atmospheric pressure plasma in treatment of periodontitis: a randomized controlled clinical trial.,"OBJECTIVES


In this clinical study, we aim to evaluate the effectiveness of non-thermal atmospheric pressure plasma (NAPP), which is a novel procedure used in periodontal pocket decontamination adjunctive to non-surgical periodontal treatment (NSPT).
METHODS


The study included 25 systemically healthy periodontitis patients. In the split-mouth design, NAPP application into the pockets, in addition to NSPT, was performed. Clinical periodontal data, gingival crevicular fluid, and subgingival plaque samples of patients were taken before and during the first and third months of treatment. Biochemical assays were conducted using enzyme-linked immunosorbent assay. Analysis of bacteria was performed with polymerase chain reaction method.
RESULTS


There was more clinical attachment level (CAL) gain in the 3rd month in the test group (deep pockets: 3.90 mm, pockets ≥ 5 mm: 2.72 mm) compared to the control group (deep pockets: 3.40 mm, pockets ≥ 5 mm: 2.58 mm) (p < 0.05), but no significant difference between groups in CAL. Clinical periodontal parameters improved in both study groups (p < 0.05). However, the gingival index (GI) and the bleeding on probing (BOP) rate decreased more in the test group (GI: 0.55, BOP: 9.48%, and GI: 0.38, BOP: 8.46% in the 1st and 3rd months, respectively) compared to the control group (GI: 0.68, BOP: 13.43%, and GI: 0.52, BOP: 14.58%) (p < 0.05). In addition, there was no significant difference in probing depth and biochemical markers between groups (p > 0.05). It was observed that NAPP reduced the number of bacteria more than the control group in the 1st and 3rd months.
CONCLUSIONS


It was seen that the single-time NAPP application concurrent with NSPT provided additional CAL gain, elimination of putative periodontopathogens and reduced their recolonization. Longitudinal studies with larger population and longer time are required.
CLINICAL RELEVANCE


NSPT is an effective method for the treatment of periodontitis but bacteria recolonization that causes recurrence of the periodontal disease occurs within a short period. NAPP can reduce the recurrence of periodontal disease by providing better bacterial elimination and should, therefore, be used in maintenance of periodontitis.",2020,"In addition, there was no significant difference in probing depth and biochemical markers between groups (p > 0.05).","['25 systemically healthy periodontitis patients', 'periodontitis']","['NAPP', 'non-thermal atmospheric pressure plasma (NAPP', 'non-thermal atmospheric pressure plasma']","['number of bacteria', 'clinical attachment level (CAL) gain', 'Clinical periodontal parameters', 'probing depth and biochemical markers', 'gingival index (GI) and the bleeding on probing (BOP) rate', 'Clinical periodontal data, gingival crevicular fluid, and subgingival plaque samples']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2936478', 'cui_str': 'Cold Plasma'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0017569', 'cui_str': 'Gingival Index'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0399451', 'cui_str': 'Subgingival plaque (disorder)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]",,0.0446573,"In addition, there was no significant difference in probing depth and biochemical markers between groups (p > 0.05).","[{'ForeName': 'Diğdem', 'Initials': 'D', 'LastName': 'Küçük', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Levent', 'Initials': 'L', 'LastName': 'Savran', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Utku Kürşat', 'Initials': 'UK', 'LastName': 'Ercan', 'Affiliation': 'Faculty of Engineering and Architecture, Department of Biomedical Engineering, Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Ziyşan Buse', 'Initials': 'ZB', 'LastName': 'Yarali', 'Affiliation': 'Department of Biomedical Engineering, Tissue Engineering and Regenerative Medicine Laboratory, Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Ozan', 'Initials': 'O', 'LastName': 'Karaman', 'Affiliation': 'Faculty of Engineering and Architecture, Department of Biomedical Engineering, Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Alpdoğan', 'Initials': 'A', 'LastName': 'Kantarci', 'Affiliation': 'The Forsyth Institute, Department of Applied Oral Sciences, Center for Periodontology, Cambridge, USA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Sağlam', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Katip Celebi University, Izmir, Turkey.'}, {'ForeName': 'Serhat', 'Initials': 'S', 'LastName': 'Köseoğlu', 'Affiliation': 'Faculty of Dentistry, Department of Periodontology, Katip Celebi University, Izmir, Turkey. serhatkoseoglu@gmail.com.'}]",Clinical oral investigations,['10.1007/s00784-019-03187-2']
614,31932363,Propofol for endotracheal intubation in neonates: a dose-finding trial.,"OBJECTIVE


To find propofol doses providing effective sedation without side effects in neonates of different gestational ages (GA) and postnatal ages (PNA).
DESIGN AND SETTING


Prospective multicentere dose-finding study in 3 neonatal intensive care units.
PATIENTS


Neonates with a PNA <28 days requiring non-emergency endotracheal intubation.
INTERVENTIONS


Neonates were stratified into 8 groups based on GA and PNA. The first 5 neonates in every group received a dose of 1.0 mg/kg propofol. Based on sedative effect and side effects, the dose was increased or decreased in the next 5 patients until the optimal dose was found.
MAIN OUTCOME MEASURES


The primary outcome was the optimal single propofol starting dose that provides effective sedation without side effects in each age group.
RESULTS


After inclusion of 91 patients, the study was prematurely terminated because the primary outcome was only reached in 13% of patients. Dose-finding was completed in 2 groups, but no optimal propofol dose was found. Effective sedation without side effects was achieved more often after a starting dose of 2.0 mg/kg (28%) than after 1.0 mg/kg (3%) and 1.5 mg/kg (9%). Propofol-induced hypotension occurred in 59% of patients. Logistic regression analyses showed that GA and PNA did not predict effective sedation or the occurrence of hypotension.
CONCLUSIONS


Effective sedation without side effects is difficult to achieve with propofol and the optimal dose in different age groups of neonates could not be determined. The sedative effect of propofol and the occurrence of hypotension are unpredictable and show large inter-individual variability in the neonatal population.",2020,Effective sedation without side effects was achieved more often after a starting dose of 2.0 mg/kg (28%) than after 1.0 mg/kg (3%) and 1.5 mg/kg (9%).,"['neonates', 'Neonates with a PNA <28 days requiring non-emergency endotracheal intubation', 'neonates of different gestational ages (GA) and postnatal ages (PNA', '3 neonatal intensive care units']","['Propofol', 'GA and PNA', 'propofol']","['sedative effect and side effects', 'optimal single propofol starting dose that provides effective sedation without side effects', 'hypotension']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C3179159', 'cui_str': 'Sedative Effect'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]",91.0,0.0744479,Effective sedation without side effects was achieved more often after a starting dose of 2.0 mg/kg (28%) than after 1.0 mg/kg (3%) and 1.5 mg/kg (9%).,"[{'ForeName': 'Ellen H M', 'Initials': 'EHM', 'LastName': 'de Kort', 'Affiliation': 'Neonatology, Maxima Medical Center, Veldhoven, The Netherlands e.dekort@mmc.nl.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Prins', 'Affiliation': 'Neonatology, Amsterdam UMC location VU Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Irwin K M', 'Initials': 'IKM', 'LastName': 'Reiss', 'Affiliation': ""Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Sten P', 'Initials': 'SP', 'LastName': 'Willemsen', 'Affiliation': 'Biostatistics, Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Andriessen', 'Affiliation': 'Neonatology, Maxima Medical Center, Veldhoven, The Netherlands.'}, {'ForeName': 'Mirjam M', 'Initials': 'MM', 'LastName': 'van Weissenbruch', 'Affiliation': 'Neonatology, Amsterdam UMC location VU Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Sinno H P', 'Initials': 'SHP', 'LastName': 'Simons', 'Affiliation': ""Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands.""}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-318474']
615,31928313,In vivo carbon dioxide clearance of a low-flow extracorporeal carbon dioxide removal circuit in patients with acute exacerbations of chronic obstructive pulmonary disease.,"BACKGROUND


Veno-venous extracorporeal carbon dioxide removal allows clearance of CO 2  from the blood and is becoming popular to enhance protective mechanical ventilation and assist in the management of acute exacerbations of chronic obstructive pulmonary disease, including the prevention of intubation. The main factor determining CO 2  transfer across a membrane lung for any given blood flow rate and venous CO 2  content is the sweep gas flow rate. The in vivo characteristics of CO 2  clearance using ultra-low blood flow devices in patients with acute exacerbations of chronic obstructive pulmonary disease has not been previously described.
METHODS


Patients commenced on extracorporeal carbon dioxide removal for acute exacerbations of chronic obstructive pulmonary disease recruited to a randomized controlled trial of non-invasive ventilation versus extracorporeal carbon dioxide removal had pre- and post-membrane circuit gases measured after each increment of sweep gas flow to allow calculation of the transmembrane CO 2  clearance. This was compared with the clearance reported by the device and also corrected to inlet PCO 2  to allow characterization of the CO 2  clearance of the device at different sweep gas flow rates.
RESULTS


CO 2  clearance was calculated using both the transmembrane CO 2  whole-blood content difference and CO 2  clearance reported by the device. The two methods demonstrated a linear relationship and agreement with a bias of 14 mL/minute (SD = ±10) and an R 2  of 0.92. The membrane CO 2  clearance was non-linear with nearly two thirds of total clearance achieved with sweep gas flow below 2 L/minute (VCO 2  of 40 ± 16.7 mL/minute) and a plateau above 5 L/minute sweep gas flow (VCO 2  64 ± 1 2.4 mL/minute).
CONCLUSION


The extracorporeal carbon dioxide removal device used in the study provides efficient clearance of CO 2  at low sweep flow rates which then plateaus. This has implications for how the device may be used in clinical practice, particularly during the weaning phase where the final discontinuation of the device may take longer than anticipated. (ClinicalTrials.gov: NCT02086084, registered 13 March 2014, https://clinicaltrials.gov/ct2/show/NCT02086084 ).",2020,The two methods demonstrated a linear relationship and agreement with a bias of 14 mL/minute (SD = ±10) and an R 2  of 0.92.,"['Patients commenced on', 'for acute exacerbations of chronic obstructive pulmonary disease', 'patients with acute exacerbations of chronic obstructive pulmonary disease']","['vivo carbon dioxide clearance of a low-flow extracorporeal carbon dioxide removal circuit', 'extracorporeal carbon dioxide removal device', 'non-invasive ventilation versus extracorporeal carbon dioxide removal had pre- and post-membrane circuit gases', 'ultra-low blood flow devices', 'extracorporeal carbon dioxide removal']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}]","[{'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0398339', 'cui_str': 'Extracorporeal carbon dioxide removal (procedure)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1997883', 'cui_str': 'Non Invasive Ventilation'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]",[],,0.210584,The two methods demonstrated a linear relationship and agreement with a bias of 14 mL/minute (SD = ±10) and an R 2  of 0.92.,"[{'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Barrett', 'Affiliation': ""Centre for Human & Applied Physiological Sciences (CHAPS) and School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hart', 'Affiliation': ""Centre for Human & Applied Physiological Sciences (CHAPS) and School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Camporota', 'Affiliation': ""Centre for Human & Applied Physiological Sciences (CHAPS) and School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}]",Perfusion,['10.1177/0267659119896531']
616,30293945,First-in-man Safety and Efficacy of the ClearRing Implant for the Treatment of Benign Prostatic Hyperplasia.,"BACKGROUND


Although effective for benign prostatic hyperplasia (BPH), transurethral resection of the prostate (TURP) can be associated with side effects including prolonged recovery, storage and voiding symptoms, and a risk of acute urinary retention.
OBJECTIVE


To test a new minimally invasive device for the treatment of lower urinary tract symptoms (LUTS) due to BPH, involving implantation of a C-shaped nitinol ring (ClearRing) in a circular incision in the prostatic tissue using an electrocuting blade over a dilatation balloon.
DESIGN, SETTING, AND PARTICIPANTS


This was a multicenter single-arm clinical trial involving 29 men with severe symptomatic BPH.
INTERVENTION


Implantation of a ClearRing device under regional anesthesia.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Effectiveness in alleviating LUTS was assessed in terms of International Prostate Symptom Score (IPSS) at baseline and 3, 6, and 12 mo after the procedure. To evaluate changes from baseline, a general estimating equation model was fitted to IPSS, the Quality of Life (QOL) scale, Benign Prostatic Hyperplasia Impact Index, maximum flow rate (Q max ), and postvoid residual volume. Statistical significance was defined as p<0.05.
RESULTS AND LIMITATIONS


The average age was 71.4 yr, prostate size was 35-50cm 3 , and IPSS was 21.6. All procedures were successfully completed with one implant in 28 patients and two implants in one patient. No serious complications occurred. Patients experienced symptom relief by 3 mo that was sustained to 12 mo. Mean IPSS, QOL, and Q max  improved by 45%, 41%, and 40% by 3 mo, and 53%, 52%, and 49% by 12 mo, respectively (p<0.05). Adverse events were mild and transient. There were no reports of loss of antegrade ejaculation or any effects on erectile function. Implantation positioning failed in 11/29 patients, who then underwent uneventful TURP. After modification of the delivery device, the success rate for implant positioning improved from 5/13 patients to 13/16 patients. Study limitations include the single-arm nature and the low patient number.
CONCLUSIONS


We demonstrated preliminary feasibility of the ClearRing device for minimally invasive treatment of BPH in men. Further studies are needed to confirm the safety and efficacy of this approach.
PATIENT SUMMARY


In this study we tested outcomes after implantation of a ClearRing device in patients with benign prostatic hyperplasia. We found that the device was safe and effective. However, there was a high rate of implantation failure due to malpositioning, which was significantly improved following modification of the delivery device.",2020,"After modification of the delivery device, the success rate for implant positioning improved from 5/13 patients to 13/16 patients.","['benign prostatic hyperplasia (BPH), transurethral resection of the prostate (TURP', '29 men with severe symptomatic BPH', 'men', 'patients with benign prostatic hyperplasia', 'Benign Prostatic Hyperplasia']","['ClearRing device', 'Implantation of a ClearRing device under regional anesthesia', 'ClearRing Implant']","['success rate for implant positioning', 'Adverse events', 'International Prostate Symptom Score (IPSS', 'erectile function', 'antegrade ejaculation', 'rate of implantation failure', 'symptom relief', 'Quality of Life (QOL) scale, Benign Prostatic Hyperplasia Impact Index, maximum flow rate (Q max ), and postvoid residual volume', 'Mean IPSS, QOL, and Q max']","[{'cui': 'C1704272', 'cui_str': 'Benign Prostatic Hyperplasia'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0040771', 'cui_str': 'Prostatectomy, Transurethral'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0002911', 'cui_str': 'Anesthesia, Regional'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0677513', 'cui_str': 'Antegrade (qualifier value)'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C3472216', 'cui_str': 'Benign prostatic hyperplasia impact index (assessment scale)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",29.0,0.118314,"After modification of the delivery device, the success rate for implant positioning improved from 5/13 patients to 13/16 patients.","[{'ForeName': 'Egils', 'Initials': 'E', 'LastName': 'Vjaters', 'Affiliation': 'Department of Urology, Pauls Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nitsan', 'Affiliation': 'ProArc Medical, Caesarea, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mullerad', 'Affiliation': 'Department of Urology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Dov', 'Initials': 'D', 'LastName': 'Engelstein', 'Affiliation': 'Department of Urology, Galilee Medical Center, Nahariya, Israel.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Leibovitch', 'Affiliation': 'Department of Urology, Meir Medical Center, Kfar-Saba, Israel.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Feld', 'Affiliation': 'ProArc Medical, Caesarea, Israel; Department of Cardiology, Rambam Health Care Campus, Haifa, Israel. Electronic address: y_feld@rambam.health.gov.il.'}]",European urology focus,['10.1016/j.euf.2018.09.013']
617,30883268,"Optimizing screening, brief intervention, and referral to treatment (SBIRT) training for nurses and social workers: Testing the added effect of online patient simulation.","Background:  Social workers and nurses are critical to the amelioration of substance misuse, making their training in evidence-based practices such as screening, brief intervention, and referral to treatment (SBIRT) particularly pertinent. Online patient simulation (OPS) is one training modality that allows students to develop and practice SBIRT skills that they might not obtain through didactic instruction, but it can be time and resource intensive. The aim of this study was to test the effect of OPS, over and above in-person training, on students' SBIRT attitudes, knowledge, and perceived skills.  Methods:  Social work and nursing students ( N  = 308) were recruited from a college in the northeastern United States. Students in the study were randomly assigned to either training as usual (TAU), which included pre-coursework videos, in-person didactic instruction, and role-plays, or the experimental condition (EXP), consisting of TAU  plus  access to self-paced SBIRT skills practice using OPS by SIMmersion. The SBIRT Attitudes, Self-perception of Skills, and Knowledge (AKS) survey was delivered at baseline, immediately post-training, and at 30-day follow-up (post-30) to assess overall changes as well as changes in the specific domains of SBIRT confidence, importance, and attitudes. Paired  t  tests were conducted to determine differences in mean scores between time points for the entire sample. Independent-samples  t  tests were conducted to test differences between EXP and TAU on AKS scores at each time point and to test differences between high and low OPS use.  Results:  Results showed a significant difference from pre- to post-training on composite AKS scores. There were no significant differences between TAU and EXP in composite scores or by AKS domain, and no differences within the EXP group for those with high and low use.  Conclusions:  Participants in EXP did not have significantly increased AKS scores, demonstrating that access to OPS did not produce an additive effect on the acquisition of self-perceived SBIRT knowledge, attitudes, and skills.",2019,"There were no significant differences between TAU and EXP in composite scores or by AKS domain, and no differences within the EXP group for those with high and low use.
","['nurses and social workers', 'N\u2009=\u2009308) were recruited from a college in the northeastern United States', 'Social work and nursing students']","['Online patient simulation (OPS', 'training as usual (TAU), which included pre-coursework videos, in-person didactic instruction, and role-plays, or the experimental condition (EXP), consisting of TAU plus access to self-paced SBIRT skills practice using OPS by SIMmersion', 'Optimizing screening, brief intervention, and referral to treatment (SBIRT) training']","['acquisition of self-perceived SBIRT knowledge, attitudes, and skills', 'composite AKS scores', 'SBIRT Attitudes, Self-perception of Skills, and Knowledge (AKS) survey', 'AKS scores', 'TAU and EXP in composite scores']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0037444', 'cui_str': 'Social worker (occupation)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}]","[{'cui': 'C0085137', 'cui_str': 'Patient Simulation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0699820', 'cui_str': 'Role playing (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]",308.0,0.0359657,"There were no significant differences between TAU and EXP in composite scores or by AKS domain, and no differences within the EXP group for those with high and low use.
","[{'ForeName': 'Kimberly H McManama', 'Initials': 'KHM', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Health Promotion, Practice, and Innovation, Education Development Center, Waltham, Massachusetts, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Putney', 'Affiliation': 'School of Social Work, Simmons University, Boston, Massachusetts, USA.'}, {'ForeName': 'Cali-Ryan R', 'Initials': 'CR', 'LastName': 'Collin', 'Affiliation': 'School of Social Work, Simmons University, Boston, Massachusetts, USA.'}, {'ForeName': 'Rebekah S', 'Initials': 'RS', 'LastName': 'Halmo', 'Affiliation': 'School of Social Work, Simmons University, Boston, Massachusetts, USA.'}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Cadet', 'Affiliation': 'School of Social Work, Simmons University, Boston, Massachusetts, USA.'}]",Substance abuse,['10.1080/08897077.2019.1576087']
618,31184796,An open-ended primary-care group intervention for insomnia based on a self-help book - A randomized controlled trial and 4-year follow-up.,"Chronic insomnia is a common and burdensome problem for patients seeking primary care. Cognitive behavioural therapy has been shown to be effective for insomnia, also when presented with co-morbidities, but access to sleep therapists is limited. Group-treatment and self-administered treatment via self-help books have both been shown to be efficacious treatment options, and the present study aimed to evaluate the effect of an open-ended group intervention based on a self-help book for insomnia, adapted to fit a primary-care setting. Forty primary-care patients with insomnia (mean age 55 years, 80% women) were randomized to the open-ended group intervention based on a cognitive behavioural therapy for insomnia self-help book or to a care as usual/wait-list control condition. Results show high attendance to group sessions and high treatment satisfaction. Participants in the control group later received the self-help book, but without the group intervention. The book-based group treatment resulted in significantly improved insomnia severity, as well as shorter sleep-onset latency, less wake time after sleep onset, and less use of sleep medication compared with treatment as usual. The improvements were sustained at a 4-year follow-up assessment. A secondary analysis found a significant advantage of the combination of the book and the open-ended group intervention compared with when the initial control group later used only the self-help book. An open-ended treatment group based on a self-help book for insomnia thus seems to be an effective and feasible intervention for chronic insomnia in primary-care settings.",2020,A secondary analysis found a significant advantage of the combination of the book and the open-ended group intervention compared with when the initial control group later used only the self-help book.,"['patients seeking primary care', 'Forty primary-care patients with insomnia (mean age 55\u2009years, 80% women']","['open-ended primary-care group intervention for insomnia based on a self-help book ', 'Cognitive behavioural therapy', 'cognitive behavioural therapy for insomnia self-help book or to a care as usual/wait-list control condition']","['shorter sleep-onset latency, less wake time after sleep onset, and less use of sleep medication', 'insomnia severity', 'Chronic insomnia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0006002', 'cui_str': 'Books'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0751249', 'cui_str': 'Chronic Insomnia'}]",,0.0295454,A secondary analysis found a significant advantage of the combination of the book and the open-ended group intervention compared with when the initial control group later used only the self-help book.,"[{'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kaldo', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, M58, Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Bothelius', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Blom', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, M58, Karolinska University Hospital Huddinge, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lindhe', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Matilda', 'Initials': 'M', 'LastName': 'Larsson', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Kobra', 'Initials': 'K', 'LastName': 'Karimi', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Melder', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Viveka', 'Initials': 'V', 'LastName': 'Bondestam', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Ulfsparre', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Sternbrink', 'Affiliation': 'Gustavsbergs Primary Care Centre, Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Jernelöv', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Stockholm County Council, M58, Karolinska University Hospital Huddinge, Stockholm, Sweden.'}]",Journal of sleep research,['10.1111/jsr.12881']
619,31730741,In vivo comparison of the optiflow and EZ glide aortic dispersion cannulas.,"OBJECTIVES


Morbidity associated with coronary artery bypass grafts and embolization during aortic cannulation is strongly related to patient characteristics/comorbidities, arterial cannulation site used and the shape of arterial cannulae tips. The desired features of an arterial cannula should be to mitigate the morbid effects of these cannulas and to focus on achieving higher blood flows with lower cannula pressures (CPs).
MATERIALS AND METHODS


To evaluate the in vivo performance of two aortic dispersion flow cannulas: the Optiflow (Sorin Group, Italy) and EZ Glide (Edwards Lifesciences). They were evaluated for CPs, pump-flow rates (FRs), and plasma-free hemoglobin (Hb) over a 12-month period. Data were collected in a prospective, randomized (1:1), nonblinded, monocentric study with a cohort of 30 patients (optiflow group N = 15; EZ Glide group N = 15).
RESULTS


The optiflow cannula was found to have decreasing CPs as the pump FRs were increased (112.3 ± 10.9 vs 131.1 ± 11.4 mm Hg; P < .001). Results indicated no significant differences between groups for increases in plasma free Hb (P = .41) and total microembolic signals counts during the period of cardiac surgery (P = .63).
CONCLUSIONS


Both optiflow and EZ Glide dispersion flow arterial cannulas performed well, but the optiflow cannula demonstrated an ability to increase pump FRs with lower arterial line and CPs than the EZ Glide cannula. This implies an ability to improve peripheral perfusion while reducing cannula shear stress and the risk of endothelial damage, thereby having the potential to reduce the risk of atherosclerotic plaque dislodgement.",2020,"Results indicated no significant differences between groups for increases in plasma free Hb (P = .41) and total microembolic signals counts during the period of cardiac surgery (P = .63).
",['30 patients (optiflow group N\u2009=\u200915; EZ Glide group N\u2009=\u200915'],"['coronary artery bypass grafts and embolization', 'aortic dispersion flow cannulas: the Optiflow (Sorin Group, Italy) and EZ Glide (Edwards Lifesciences']","['CPs, pump-flow rates (FRs), and plasma-free hemoglobin (Hb', 'total microembolic signals counts', 'plasma free Hb']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441848', 'cui_str': 'Group N (qualifier value)'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0013931', 'cui_str': 'Embolotherapy'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0520453', 'cui_str': 'Cannula'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3854324', 'cui_str': 'Free hemoglobin'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",,0.0212447,"Results indicated no significant differences between groups for increases in plasma free Hb (P = .41) and total microembolic signals counts during the period of cardiac surgery (P = .63).
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Gennari', 'Affiliation': 'Department of Cardiovascular Surgery, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Rossi', 'Affiliation': 'Department of Cardiovascular Surgery, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Polvani', 'Affiliation': 'Department of Cardiovascular Surgery, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Bertera', 'Affiliation': 'Department of Cardiovascular Surgery, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Riva', 'Affiliation': 'Department of Cardiovascular Surgery, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}, {'ForeName': 'Antonella D', 'Initials': 'AD', 'LastName': 'Fave', 'Affiliation': 'Department of Pathophysiology and Transplantation, University of Milan, Italy.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Rassiga', 'Affiliation': 'Neurology Unit, ASST Santi Paolo e Carlo, Presidio San Paolo, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Agrifoglio', 'Affiliation': 'Department of Cardiovascular Surgery, Centro Cardiologico Monzino IRCCS, Milan, Italy.'}]",Journal of cardiac surgery,['10.1111/jocs.14347']
620,31812127,"Tolerability and efficacy of lacosamide and controlled-release carbamazepine monotherapy in patients with newly diagnosed epilepsy and concomitant psychiatric conditions: Post hoc analysis of a prospective, randomized, double-blind trial.","Psychiatric comorbidities are common in patients with epilepsy. A double-blind noninferiority monotherapy trial (SP0993; NCT01243177) enrolled newly diagnosed patients (≥16 years) with focal or generalized tonic-clonic seizures. Patients were randomized 1:1 to lacosamide or carbamazepine controlled-release (carbamazepine-CR). Here, we report data from an exploratory post hoc analysis of patients who reported ongoing psychiatric conditions (Medical Dictionary for Regulatory Activities System Organ Class). Of 886 treated patients in the trial, 126 (14.2%; 64 on lacosamide; 62 on carbamazepine-CR) reported at least one ongoing psychiatric condition at screening, most commonly depression (38.1%), insomnia (27.8%), and anxiety (26.2%). In this subgroup, 32/64 (50.0%) patients on lacosamide and 22/62 (35.5%) on carbamazepine-CR completed the trial. The most common reasons for discontinuation in patients on lacosamide and carbamazepine-CR were adverse events (10.9%, 24.2%) and lack of efficacy (18.8%, 11.3%). Treatment-emergent adverse events (TEAEs) were reported in 52 (81.3%) of patients on lacosamide and 56 (90.3%) of patients on carbamazepine-CR, most commonly (≥10% patients in either treatment group; lacosamide, carbamazepine-CR) dizziness (12.5%, 16.1%), headache (12.5%, 14.5%), nasopharyngitis (12.5%, 9.7%), fatigue (7.8%, 14.5%), nausea (7.8%, 11.3%), somnolence (1.6%, 12.9%), and gamma-glutamyltransferase increase (1.6%, 12.9%). Overall, 15 (23.4%) lacosamide-treated and 10 (16.1%) carbamazepine-CR treated patients reported psychiatric TEAEs, most commonly (≥3 patients in either treatment group; lacosamide, carbamazepine-CR) depression (4.7%, 0) and anxiety (3.1%, 6.5%). There were no reports of psychotic disorder, epileptic psychosis, acute psychosis, or serious psychiatric TEAEs. Stratified Kaplan-Meier estimates for 6- and 12-month seizure freedom at the last evaluated dose were similar with lacosamide and carbamazepine-CR (6 months 81.0%, 75.6%; 12 months 62.5%, 66.6%). A higher proportion of patients on lacosamide than carbamazepine-CR completed 6 (67.2%, 45.2%) and 12 months (50.0%, 37.1%) of treatment at the last evaluated dose without a seizure. This exploratory post hoc analysis indicated that lacosamide monotherapy was efficacious and generally well tolerated in patients with newly diagnosed epilepsy and concomitant psychiatric conditions. In this subpopulation, lacosamide showed similar efficacy and numerically better effectiveness than carbamazepine-CR.",2020,"Treatment-emergent adverse events (TEAEs) were reported in 52 (81.3%) of patients on lacosamide and 56 (90.3%) of patients on carbamazepine-CR, most commonly (≥10% patients in either treatment group; lacosamide, carbamazepine-CR) dizziness (12.5%, 16.1%), headache (12.5%, 14.5%), nasopharyngitis (12.5%, 9.7%), fatigue (7.8%, 14.5%), nausea (7.8%, 11.3%), somnolence (1.6%, 12.9%), and gamma-glutamyltransferase increase (1.6%, 12.9%).","['newly diagnosed patients (≥16 years) with focal or generalized tonic-clonic seizures', '886 treated patients in the trial, 126 (14.2%; 64 on lacosamide; 62 on carbamazepine-CR) reported at least one ongoing psychiatric condition at screening, most commonly depression (38.1%), insomnia (27.8%), and anxiety (26.2', 'patients with newly diagnosed epilepsy and concomitant psychiatric conditions', 'patients with epilepsy', 'patients who reported ongoing psychiatric conditions (Medical Dictionary for Regulatory Activities System Organ Class']","['carbamazepine', 'carbamazepine-CR', 'lacosamide and controlled-release carbamazepine monotherapy', 'lacosamide or carbamazepine controlled-release (carbamazepine-CR', 'lacosamide monotherapy']","['lack of efficacy', 'adverse events', 'fatigue', 'headache', 'gamma-glutamyltransferase increase', 'nasopharyngitis', 'psychotic disorder, epileptic psychosis, acute psychosis', 'lacosamide, carbamazepine-CR) depression', 'anxiety', 'Tolerability and efficacy', 'nausea', 'somnolence', 'lacosamide, carbamazepine-CR) dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0494475', 'cui_str': 'Generalized Tonic-Clonic Seizures'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0012113', 'cui_str': 'Dictionary, Medical'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0151662', 'cui_str': 'Gamma-glutamyl transferase raised (finding)'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0338658', 'cui_str': 'Epileptic psychosis (disorder)'}, {'cui': 'C0281774', 'cui_str': 'Acute psychosis'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",886.0,0.2116,"Treatment-emergent adverse events (TEAEs) were reported in 52 (81.3%) of patients on lacosamide and 56 (90.3%) of patients on carbamazepine-CR, most commonly (≥10% patients in either treatment group; lacosamide, carbamazepine-CR) dizziness (12.5%, 16.1%), headache (12.5%, 14.5%), nasopharyngitis (12.5%, 9.7%), fatigue (7.8%, 14.5%), nausea (7.8%, 11.3%), somnolence (1.6%, 12.9%), and gamma-glutamyltransferase increase (1.6%, 12.9%).","[{'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Schmitz', 'Affiliation': 'Vivantes Humboldt-Klinikum, Zentrum für Epilepsie, Am Nordgraben 2, 13509 Berlin, Germany. Electronic address: bettina.schmitz@vivantes.de.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Dimova', 'Affiliation': 'UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: Svetlana.Dimova@ucb.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Ying.Zhang5@ucb.com.'}, {'ForeName': 'Daya', 'Initials': 'D', 'LastName': 'Chellun', 'Affiliation': ""UCB Pharma, Chemin du Foriest 1, 1420 Braine-l'Alleud, Belgium. Electronic address: Daya.Chellun@ucb.com.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'De Backer', 'Affiliation': 'UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: Marc.DeBacker@ucb.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gasalla', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Teresa.Gasalla@ucb.com.'}]",Epilepsy research,['10.1016/j.eplepsyres.2019.106220']
621,30709746,Citalopram in first episode schizophrenia: The DECIFER trial.,"Antidepressants are frequently prescribed in first episode schizophrenia (FES) patients for negative symptoms or for subsyndromal depressive symptoms, but therapeutic benefit has not been established, despite evidence of efficacy in later-stage schizophrenia. We conducted a 52 week, placebo-controlled add-on trial of citalopram in patients with FES who did not meet criteria for major depression to determine whether maintenance therapy with citalopram would improve outcomes by preventing or improving negative and depressive symptoms. Primary outcomes were negative symptoms measured by the Scale for Assessment of Negative Symptoms and depressive symptoms measured by the Calgary Depression Scale for Schizophrenia; both were analyzed by an intent-to-treat, mixed effects, area-under-the-curve analysis to assess the cumulative effects of symptom improvement and symptom prevention over a one-year period. Ninety-five patients were randomized and 52 (54%) completed the trial. Negative symptoms were reduced with citalopram compared to placebo (p = .04); the effect size of citalopram versus placebo was 0.32 for participants with a duration of untreated psychosis (DUP) of <18 weeks (median split) and 0.52 with a DUP >18 weeks. Rates of new-onset depression did not differ between groups; improvement in depressive symptoms was greater with placebo than citalopram (p = .02). Sexual side effects were more common with citalopram, but overall treatment-emergent side effects were not increased compared to placebo. In conclusion, citalopram may reduce levels of negative symptoms, particularly in patients with longer DUP, but we found no evidence of benefit for subsyndromal depressive symptoms.",2019,Negative symptoms were reduced with citalopram compared to placebo (p = .04); the effect size of citalopram versus placebo was 0.32 for participants with a duration of untreated psychosis (DUP) of <18 weeks (median split) and 0.52 with a DUP >18 weeks.,"['first episode schizophrenia', 'Ninety-five patients were randomized and 52 (54%) completed the trial', 'patients with longer DUP', 'patients with FES who did not meet criteria for major depression to determine whether maintenance therapy with']","['citalopram', 'placebo', 'Citalopram']","['cumulative effects of symptom improvement and symptom prevention', 'negative symptoms measured by the Scale for Assessment of Negative Symptoms and depressive symptoms measured by the Calgary Depression Scale for Schizophrenia', 'overall treatment-emergent side effects', 'Rates of new-onset depression', 'depressive symptoms', 'Sexual side effects', 'Negative symptoms']","[{'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",95.0,0.540758,Negative symptoms were reduced with citalopram compared to placebo (p = .04); the effect size of citalopram versus placebo was 0.32 for participants with a duration of untreated psychosis (DUP) of <18 weeks (median split) and 0.52 with a DUP >18 weeks.,"[{'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Goff', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, 1 Park Avenue, New York, NY 10016, United States of America; Nathan Kline Institute for Psychiatric Research, 140 Old Orangeburg Road, Orangeburg, NY 10962, United States of America. Electronic address: donald.goff@nyulangone.org.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Freudenreich', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA 02144, United States of America.'}, {'ForeName': 'Corrine', 'Initials': 'C', 'LastName': 'Cather', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA 02144, United States of America.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Holt', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA 02144, United States of America.'}, {'ForeName': 'Iruma', 'Initials': 'I', 'LastName': 'Bello', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, 601 West 168th St., New York, NY 10032, United States of America.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Diminich', 'Affiliation': 'Department of Psychiatry, Stony Brook School of Medicine, 101 Nicolls Road, Stony Brook, NY 11794, United States of America.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, 600 Wanping S Road, Shanghai 200000, China.'}, {'ForeName': 'Babak A', 'Initials': 'BA', 'LastName': 'Ardekani', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, 1 Park Avenue, New York, NY 10016, United States of America; Nathan Kline Institute for Psychiatric Research, 140 Old Orangeburg Road, Orangeburg, NY 10962, United States of America.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Worthington', 'Affiliation': 'Department of Psychiatry, NYU Langone Health, 1 Park Avenue, New York, NY 10016, United States of America.'}, {'ForeName': 'Botao', 'Initials': 'B', 'LastName': 'Zeng', 'Affiliation': 'Department of Psychiatry, Qingdao Mental Health Center, 9 Dongguan Road, Qingdao 266034, China.'}, {'ForeName': 'Renrong', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'National Clinical Research Center for Mental Disorders, Mental Health Institute, The Second Xiangya Hospital of Central South University, 139 Renmin Middle Road, Changsha, Hunan, China.'}, {'ForeName': 'Xiaoduo', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Department of Psychiatry, University of Massachusetts Medical Center, Worcester, MA, United States of America.'}, {'ForeName': 'Chenxiang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Population Health, Division of Biostatistics, NYU School of Medicine, 650 First Avenue, New York, NY 10016, United States of America.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Troxel', 'Affiliation': 'Department of Population Health, Division of Biostatistics, NYU School of Medicine, 650 First Avenue, New York, NY 10016, United States of America.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, 600 Wanping S Road, Shanghai 200000, China.'}, {'ForeName': 'Jingping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'National Clinical Research Center for Mental Disorders, Mental Health Institute, The Second Xiangya Hospital of Central South University, 139 Renmin Middle Road, Changsha, Hunan, China.'}]",Schizophrenia research,['10.1016/j.schres.2019.01.028']
622,31864217,Mediators of treatment effect in minimal-contact cognitive behaviour therapy for severe health anxiety: A theory-driven analysis based on a randomised controlled trial.,"Cognitive behaviour therapy (CBT) is efficacious for severe health anxiety, but little is known about mechanisms. We analysed putative mediators of change based on 13 weekly assessments in a randomised controlled trial (N = 132) of exposure-based minimal-contact CBT (guided Internet-delivered CBT, unguided Internet-delivered CBT and bibliotherapy) vs. a waitlist control for severe health anxiety. We hypothesised that the effect of CBT on health anxiety would be mediated by non-reactivity to inner experiences, health anxiety behaviours and perceived competence. We also explored somatosensory amplification. In parallel process growth models, non-reactivity, health anxiety behaviours and perceived competence - but not somatosensory amplification - were influenced by CBT and associated with health anxiety. Random intercepts cross-lagged panel models were used to study within-individual ordering of change. None of the putative mediators systematically predicted subsequent changes in health anxiety. Rather, changes in health anxiety predicted subsequent changes in all putative mediators. In summary, CBT influenced health anxiety behaviours, non-reactivity to inner experiences and perceived competence, and these variables were associated with the outcome. However, their role as mediators was not corroborated because we found no evidence that changes in these variables predicted subsequent changes in health anxiety. We encourage further research into mediators of CBT for health anxiety.",2020,"In summary, CBT influenced health anxiety behaviours, non-reactivity to inner experiences and perceived competence, and these variables were associated with the outcome.",['severe health anxiety'],"['CBT', 'minimal-contact cognitive behaviour therapy', 'Cognitive behaviour therapy (CBT', 'exposure-based minimal-contact CBT (guided Internet-delivered CBT, unguided Internet-delivered CBT and bibliotherapy) vs. a waitlist control']","['health anxiety behaviours', 'health anxiety']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0005365', 'cui_str': 'Bibliotherapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0382256,"In summary, CBT influenced health anxiety behaviours, non-reactivity to inner experiences and perceived competence, and these variables were associated with the outcome.","[{'ForeName': 'Erland', 'Initials': 'E', 'LastName': 'Axelsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. Electronic address: erland.axelsson@ki.se.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Hesser', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden; Center for Health and Medical Psychology, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Hedman-Lagerlöf', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden; Osher Center for Integrative Medicine, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.102172']
623,31829276,Acupoint transcutaneous electrical nerve stimulation in hospitalized COPD patients with severe dyspnoea: study protocol for a randomized controlled trial.,,2019,,['hospitalized COPD patients with severe dyspnoea'],['Acupoint transcutaneous electrical nerve stimulation'],[],"[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}]","[{'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}]",[],,0.0687534,,"[{'ForeName': 'Carles', 'Initials': 'C', 'LastName': 'Fernández-Jané', 'Affiliation': 'School of Health Science Blanquerna, Ramon Llull University, Padilla 326-332, 08025, Barcelona, Spain. carlesfj@blanquerna.url.edu.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Vilaró', 'Affiliation': 'School of Health Science Blanquerna, Ramon Llull University, Padilla 326-332, 08025, Barcelona, Spain.'}]",Trials,['10.1186/s13063-019-3757-x']
624,31672681,Prevention of Fascial Dehiscence with Onlay Prophylactic Mesh in Emergency Laparotomy: A Randomized Clinical Trial.,"BACKGROUND


Fascial dehiscence (FD) occurs in up to 14.9% of high-risk patients undergoing emergency laparotomy. Although prophylactic mesh can prevent FD, its use in emergency operations remains controversial.
STUDY DESIGN


A prospective randomized clinical trial was conducted at the Hospital das Clínicas from Faculdade de Medicina da Universidade de São Paulo in Brazil. It was performed among high-risk patients, defined according to Rotterdam risk model, undergoing midline emergency laparotomy. The patients were randomized into the suture group (SG), with slowly absorbable running sutures placed with a 36-mm-long needle at a suture-to-wound length ratio of 4:1, and the prophylactic mesh group (PMG), with fascial closure as in the SG but reinforced with onlay polypropylene mesh. The primary end point was incidence of FD at 30 days post operation.
RESULTS


We analyzed 115 patients; 52 and 63 were allocated to the SG and PMG, respectively. In all, 77.4% of the cases were for colorectal resection. FD occurred in 7 (13.5%) patients in the SG and none in the PMG (p = 0.003). There was no difference between the groups in number of patients with surgical site occurrence (SSO) or SSO requiring procedural intervention. However, some specific SSOs had higher incidences in the mesh group: surgical site infection (20.6% versus 7.7%; p = 0.05), seroma (19.0% versus 5.8%; p = 0.03), and nonhealing incisional wound (23.8% versus 5.8%; p = 0.008). Of SSOs in the PMG and SG, 92.3% and 73.3%, respectively, resolved spontaneously or with bedside interventions.
CONCLUSIONS


Prophylactic onlay mesh reinforcement in emergency laparotomy is safe and prevents FD. Surgical site infection, seroma, and nonhealing incisional wound were more common in the mesh group, but associated with low morbidity within 30 days post operation.",2020,There was no difference between the groups regarding the number of patients with surgical site occurrence (SSO) or SSO requiring procedural intervention.,"['Emergency Laparotomy', 'Hospital das Clínicas from Faculdade de Medicina da Universidade de São Paulo in Brazil', '115 patients; 52 and 63']","['suture group (SG), with slowly absorbable running sutures placed with a 36-mm-long needle at a suture-to-wound length ratio of 4:1, and the prophylactic mesh group (PMG), with fascial closure as in the SG but reinforced with onlay polypropylene mesh', 'Fascial Dehiscence with Onlay Prophylactic Mesh']","['incidence of FD', 'nonhealing incisional wound', 'seroma', 'FD', 'surgical site infection', 'Surgical site infection, seroma and nonhealing incisional wound', 'low morbidity', 'number of patients with surgical site occurrence (SSO']","[{'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0015641', 'cui_str': 'Fascia'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0677511', 'cui_str': 'Onlay (qualifier value)'}, {'cui': 'C1321585', 'cui_str': 'Polypropylene mesh (physical object)'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",115.0,0.0552562,There was no difference between the groups regarding the number of patients with surgical site occurrence (SSO) or SSO requiring procedural intervention.,"[{'ForeName': 'Helber V G', 'Initials': 'HVG', 'LastName': 'Lima', 'Affiliation': 'Department of Surgery, Discipline of General Surgery and Trauma, Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil. Electronic address: helber.vidal@hc.fm.usp.br.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Rasslan', 'Affiliation': 'Department of Surgery, Discipline of General Surgery and Trauma, Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fernando C F', 'Initials': 'FCF', 'LastName': 'Novo', 'Affiliation': 'Department of Surgery, Discipline of General Surgery and Trauma, Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Tibério M A', 'Initials': 'TMA', 'LastName': 'Lima', 'Affiliation': 'Department of Surgery, Discipline of General Surgery and Trauma, Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Sérgio H B', 'Initials': 'SHB', 'LastName': 'Damous', 'Affiliation': 'Department of Surgery, Discipline of General Surgery and Trauma, Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Celso O', 'Initials': 'CO', 'LastName': 'Bernini', 'Affiliation': 'Department of Surgery, Discipline of General Surgery and Trauma, Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Edna F S', 'Initials': 'EFS', 'LastName': 'Montero', 'Affiliation': 'Department of Surgery, Discipline of General Surgery and Trauma, Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Edivaldo M', 'Initials': 'EM', 'LastName': 'Utiyama', 'Affiliation': 'Department of Surgery, Discipline of General Surgery and Trauma, Hospital das Clínicas da Universidade de São Paulo, São Paulo, Brazil.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2019.09.010']
625,31899004,Fidelity and feasibility of a multicomponent physical activity intervention in a retirement community.,"This pilot study examined the fidelity and feasibility of a multicomponent physical activity intervention in a retirement community. Eighteen older adults participated in an 8-week intervention. The intervention included offering group exercise lessons, combined with providing participants wearable activity trackers. Quantitative and qualitative data were collected to assess the feasibility and fidelity. The retention of the study was 83.3% and the average attendance of group lessons was 88.2%. Participants wore the activity trackers on 93.9% of the required days. Individual interviews indicated that participants were generally satisfied with the intervention. However, the Tai Chi session of exercise lessons and the activity trackers were not favored by the majority of the participants. Future interventions should provide tailored and adaptable exercise programs to meet the various physical health conditions of older adults and ease the use of technology to facilitate behavior change.",2020,"However, the Tai Chi session of exercise lessons and the activity trackers were not favored by the majority of the participants.",['Eighteen older adults participated in an 8-week intervention'],"['group exercise lessons, combined with providing participants wearable activity trackers', 'multicomponent physical activity intervention']","['feasibility and fidelity', 'activity trackers']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise (regime/therapy)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C4264352', 'cui_str': 'Activity Trackers'}]",18.0,0.0174244,"However, the Tai Chi session of exercise lessons and the activity trackers were not favored by the majority of the participants.","[{'ForeName': 'Zhanjia', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giordani', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Weiyun', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, MI 48109, USA. Electronic address: chenwy@umich.edu.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2019.12.002']
626,31862329,Computerized Advisory Decision Support for Cardiovascular Diseases in Primary Care: A Cluster Randomized Trial.,"PURPOSE


The purpose of this research was to evaluate the impact of an outpatient computerized advisory clinical decision support system (CDSS) on adherence to guideline-recommended treatment for heart failure, atrial fibrillation, and hyperlipidemia.
METHODS


Twenty care teams (109 clinicians) in a primary care practice were cluster-randomized to either access or no access to an advisory CDSS integrated into the electronic medical record. For patients with an outpatient visit, the CDSS determined if they had heart failure with reduced ejection fraction, hyperlipidemia, or atrial fibrillation; and if so, was the patient receiving guideline-recommended treatment. In the intervention group, an alert was visible in the medical record if there was a discrepancy between current and guideline-recommended treatment. Clicking the alert displayed the treatment discrepancy and recommended treatment. Outcomes included prescribing patterns, self-reported use of decision aids, and self-reported efficiency. The trial was conducted between May 1 and November 15, 2016, and incorporated 16,310 patient visits.
RESULTS


The advisory CDSS increased adherence to guideline-recommended treatment for heart failure (odds ratio [OR] 7.6, 95% confidence interval [CI], 1.2, 47.5) but had no impact in atrial fibrillation (OR 0.94, 95% CI 0.15, 5.94) or hyperlipidemia (OR 1.1, 95% CI 0.6, 1.8). Clinicians with access to the CDSS self-reported greater use of risk assessment tools for heart failure (3.6 [1.1] vs 2.7 [1.0], mean [standard deviation] on a 5-point scale) but not for atrial fibrillation or hyperlipidemia. The CDSS did not impact self-assessed efficiency. The overall usage of the CDSS was low (19%).
CONCLUSIONS


A computerized advisory CDSS improved adherence to guideline-recommended treatment for heart failure but not for atrial fibrillation or hyperlipidemia.",2020,A computerized advisory CDSS improved adherence to guideline-recommended treatment for heart failure but not for atrial fibrillation or hyperlipidemia.,"['May 1 and November 15, 2016 and incorporated 16,310 patient visits', 'Twenty care teams (109 clinicians) in a primary care practice were cluster-randomized to either', 'Primary Care']","['outpatient computerized advisory clinical decision support system (CDSS', 'access or no access to an advisory CDSS integrated into the electronic medical record']","['hyperlipidemia', 'prescribing patterns, self-reported use of decision aids and self-reported efficiency', 'heart failure with reduced ejection fraction, hyperlipidemia, and/or atrial fibrillation', 'overall usage of the CDSS', 'atrial fibrillation or hyperlipidemia', 'atrial fibrillation', 'heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0525070', 'cui_str': 'Decision Support Systems, Clinical'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}]","[{'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}]",,0.0365495,A computerized advisory CDSS improved adherence to guideline-recommended treatment for heart failure but not for atrial fibrillation or hyperlipidemia.,"[{'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'McKie', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minn. Electronic address: mckie.paul@mayo.edu.'}, {'ForeName': 'Daryl J', 'Initials': 'DJ', 'LastName': 'Kor', 'Affiliation': 'Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minn; Department of Anesthesiology, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cook', 'Affiliation': 'Office of Information and Knowledge Management, Mayo Clinic, Rochester, Minn; Division of General Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Maya E', 'Initials': 'ME', 'LastName': 'Kessler', 'Affiliation': 'Division of Primary Care Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Rickey E', 'Initials': 'RE', 'LastName': 'Carter', 'Affiliation': 'Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minn; Department of Health Sciences Research, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Wilson', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Laurie J', 'Initials': 'LJ', 'LastName': 'Pencille', 'Affiliation': 'Robert D and Patricia E Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minn; Office of Information and Knowledge Management, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Branden C', 'Initials': 'BC', 'LastName': 'Hickey', 'Affiliation': 'Office of Information and Knowledge Management, Mayo Clinic, Rochester, Minn.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chaudhry', 'Affiliation': 'Office of Information and Knowledge Management, Mayo Clinic, Rochester, Minn; Division of Primary Care Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, Minn.'}]",The American journal of medicine,['10.1016/j.amjmed.2019.10.039']
627,30704862,Efficacy of high-frequency repetitive transcranial magnetic stimulation in schizophrenia patients with treatment-resistant negative symptoms treated with clozapine.,"BACKGROUND


Repetitive transcranial magnetic stimulation (rTMS) is a promising augmentation treatment for schizophrenia, however there are few controlled studies of rTMS augmentation of clozapine.
METHODS


Using data from the 'rTMS for the Treatment of Negative Symptoms in Schizophrenia' (RESIS) trial we examined the impact of rTMS on PANSS total, general, positive and negative symptoms among participants on clozapine. rTMS was applied to the left dorsolateral prefrontal cortex (DLPFC) for five treatment sessions/week for 3-weeks as augmentation for patients with a predominant negative syndrome of schizophrenia, as rated on PANSS.
RESULTS


26 participants from the RESIS trial were on clozapine, receiving active (N=12) or sham (N=14) rTMS treatment. In our Linear Mixed Model (LMM) analysis, time×group interactions were significant in the PANSS positive subscale (p=0.003) (not being the corresponding behavioral output for DLPFC stimulation), the PANSS general subscale (p<0.001), the PANSS total scale (p=0.015), but not the PANSS negative subscale (p=0.301) (primary endpoint of the RESIS trial), when all PANSS measurements from screening to day 105 were included. Descriptive data suggests that in the active group the improvement was more pronounced compared to the sham rTMS group.
CONCLUSIONS


In this largest available clozapine cohort, active rTMS may be more effective than sham rTMS when added to clozapine for positive and total psychotic symptoms. These findings should be interpreted with caution given this is a secondary analysis with a limited number of participants.",2019,"In our Linear Mixed Model (LMM) analysis, time×group interactions were significant in the PANSS positive subscale (p=0.003) (not being the corresponding behavioral output for DLPFC stimulation), the PANSS general subscale (p<0.001), the PANSS total scale (p=0.015), but not the PANSS negative subscale (p=0.301) (primary endpoint of the RESIS trial), when all PANSS measurements from screening to day 105 were included.","['schizophrenia patients with treatment-resistant negative symptoms treated with', ""Using data from the 'rTMS for the Treatment of Negative Symptoms in Schizophrenia' (RESIS) trial"", 'patients with a predominant negative syndrome of schizophrenia, as rated on PANSS', '26 participants from the RESIS trial were on']","['high-frequency repetitive transcranial magnetic stimulation', 'clozapine', 'rTMS', 'Repetitive transcranial magnetic stimulation (rTMS']","['PANSS positive subscale', 'PANSS total scale']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0009079', 'cui_str': 'Clozapine'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0222045'}]",26.0,0.0466626,"In our Linear Mixed Model (LMM) analysis, time×group interactions were significant in the PANSS positive subscale (p=0.003) (not being the corresponding behavioral output for DLPFC stimulation), the PANSS general subscale (p<0.001), the PANSS total scale (p=0.015), but not the PANSS negative subscale (p=0.301) (primary endpoint of the RESIS trial), when all PANSS measurements from screening to day 105 were included.","[{'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Wagner', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Klinikum der Universität München, University Hospital, LMU Munich, Germany. Electronic address: Elias.Wagner@med.uni-muenchen.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wobrock', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Georg-August-University Goettingen, Germany; County Hospitals Darmstadt-Dieburg, Groß-Umstadt, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Kunze', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Georg-August-University Goettingen, Germany.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Langguth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Landgrebe', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany; Department of Psychiatry, Psychosomatics and Psychotherapy, kbo-Lech-Mangfall-Klinik Agatharied, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Eichhammer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Elmar', 'Initials': 'E', 'LastName': 'Frank', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Regensburg, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Cordes', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wölwer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Winterer', 'Affiliation': 'Experimental & Clinical Research Center (ECRC), Department of Anesthesiology and Operative Intensive Care Medicine, Charité - University Medicine Berlin, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Gaebel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Hajak', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Sozialstiftung Bamberg, Bamberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ohmann', 'Affiliation': 'European Clinical Research Network (ECRIN), Düsseldorf, Germany.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Verde', 'Affiliation': 'Coordination Centre for Clinical Trials, Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Rietschel', 'Affiliation': 'Department of Genetic Epidemiology in Psychiatry, Institute of Central Mental Health, Medical Faculty Mannheim, University of Heidelberg, Germany.'}, {'ForeName': 'Raees', 'Initials': 'R', 'LastName': 'Ahmed', 'Affiliation': 'Studienzentrum, Universitätsmedizin Göttingen, Germany.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Honer', 'Affiliation': 'Institute of Mental Health, The University of British Columbia, Canada.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Siskind', 'Affiliation': 'School of Medicine, University of Queensland, Brisbane, Australia; Metro South Addiction and Mental Health Service, Brisbane, Australia.'}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Malchow', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Jena, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Strube', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Klinikum der Universität München, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schneider-Axmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Klinikum der Universität München, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Falkai', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Klinikum der Universität München, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Alkomiet', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Klinikum der Universität München, University Hospital, LMU Munich, Germany.'}]",Schizophrenia research,['10.1016/j.schres.2019.01.021']
628,31898880,Multicenter Ozone Study in oldEr Subjects (MOSES): Part 1. Effects of Exposure to Low Concentrations of Ozone on Respiratory and Cardiovascular Outcomes.,"INTRODUCTION


Exposure to air pollution is a well-established risk factor for cardiovascular morbidity and mortality. Most of the evidence supporting an association between air pollution and adverse cardiovascular effects involves exposure to particulate matter (PM). To date, little attention has been paid to acute cardiovascular responses to ozone, in part due to the notion that ozone causes primarily local effects on lung function, which are the basis for the current ozone National Ambient Air Quality Standards (NAAQS). There is evidence from a few epidemiological studies of adverse health effects of chronic exposure to ambient ozone, including increased risk of mortality from cardiovascular disease. However, in contrast to the well-established association between ambient ozone and various nonfatal adverse respiratory effects, the observational evidence for impacts of acute (previous few days) increases in ambient ozone levels on total cardiovascular mortality and morbidity is mixed.
Ozone is a prototypic oxidant gas that reacts with constituents of the respiratory tract lining fluid to generate reactive oxygen species (ROS) that can overwhelm antioxidant defenses and cause local oxidative stress. Pathways by which ozone could cause cardiovascular dysfunction include alterations in autonomic balance, systemic inflammation, and oxidative stress. These initial responses could lead ultimately to arrhythmias, endothelial dysfunction, acute arterial vasoconstriction, and procoagulant activity. Individuals with impaired antioxidant defenses, such as those with the null variant of glutathione S-transferase mu 1 (GSTM1), may be at increased risk for acute health effects.
The Multicenter Ozone Study in oldEr Subjects (MOSES) was a controlled human exposure study designed to evaluate whether short-term exposure of older, healthy individuals to ambient levels of ozone induces acute cardiovascular responses. The study was designed to test the a priori hypothesis that short-term exposure to ambient levels of ozone would induce acute cardiovascular responses through the following mechanisms: autonomic imbalance, systemic inflammation, and development of a prothrombotic vascular state. We also postulated a priori the confirmatory hypothesis that exposure to ozone would induce airway inflammation, lung injury, and lung function decrements. Finally, we postulated the secondary hypotheses that ozone-induced acute cardiovascular responses would be associated with: (a) increased systemic oxidative stress and lung effects, and (b) the GSTM1-null genotype.
METHODS


The study was conducted at three clinical centers with a separate Data Coordinating and Analysis Center (DCAC) using a common protocol. All procedures were approved by the institutional review boards (IRBs) of the participating centers. Healthy volunteers 55 to 70 years of age were recruited. Consented participants who successfully completed the screening and training sessions were enrolled in the study. All three clinical centers adhered to common standard operating procedures (SOPs) and used common tracking and data forms. Each subject was scheduled to participate in a total of 11 visits: screening visit, training visit, and three sets of exposure visits, each consisting of the pre-exposure day, the exposure day, and the post-exposure day. The subjects spent the night in a nearby hotel the night of the pre-exposure day.
On exposure days, the subjects were exposed for three hours in random order to 0 ppb ozone (clean air), 70 ppb ozone, and 120 ppm ozone, alternating 15 minutes of moderate exercise with 15 minutes of rest. A suite of cardiovascular and pulmonary endpoints was measured on the day before, the day of, and up to 22 hours after, each exposure. The endpoints included: (1) electrocardiographic changes (continuous Holter monitoring: heart rate variability [HRV], repolarization, and arrhythmia); (2) markers of inflammation and oxidative stress (C-reactive protein [CRP], interleukin-6 [IL-6], 8-isoprostane, nitrotyrosine, and P-selectin); (3) vascular function measures (blood pressure [BP], flow-mediated dilatation [FMD] of the brachial artery, and endothelin-1 [ET-1]; (4) venous blood markers of platelet activation, thrombosis, and microparticle-associated tissue factor activity (MP-TFA); (5) pulmonary function (spirometry); (6) markers of airway epithelial cell injury (increases in plasma club cell protein 16 [CC16] and sputum total protein); and (7) markers of lung inflammation in sputum (polymorphonuclear leukocytes [PMN], IL-6, interleukin-8 [IL-8], and tumor necrosis factor-alpha [TNF-α]). Sputum was collected only at 22 hours after exposure.
The analyses of the continuous electrocardiographic monitoring, the brachial artery ultrasound (BAU) images, and the blood and sputum samples were carried out by core laboratories. The results of all analyses were submitted directly to the DCAC.
The variables analyzed in the statistical models were represented as changes from pre-exposure to post-exposure (post-exposure minus pre-exposure). Mixed-effect linear models were used to evaluate the impact of exposure to ozone on the prespecified primary and secondary continuous outcomes. Site and time (when multiple measurements were taken) were controlled for in the models. Three separate interaction models were constructed for each outcome: ozone concentration by subject sex; ozone concentration by subject age; and ozone concentration by subject GSTM1 status (null or sufficient). Because of the issue of multiple comparisons, the statistical significance threshold was set a priori at  P  < 0.01.
RESULTS


Subject recruitment started in June 2012, and the first subject was randomized on July 25, 2012. Subject recruitment ended on December 31, 2014, and testing of all subjects was completed by April 30, 2015. A total of 87 subjects completed all three exposures. The mean age was 59.9 ± 4.5 years, 60% of the subjects were female, 88% were white, and 57% were GSTM1 null. Mean baseline body mass index (BMI), BP, cholesterol (total and low-density lipoprotein), and lung function were all within the normal range.
We found no significant effects of ozone exposure on any of the primary or secondary endpoints for autonomic function, repolarization, ST segment change, or arrhythmia. Ozone exposure also did not cause significant changes in the primary endpoints for systemic inflammation (CRP) and vascular function (systolic blood pressure [SBP] and FMD) or secondary endpoints for systemic inflammation and oxidative stress (IL-6, P-selectin, and 8-isoprostane). Ozone did cause changes in two secondary endpoints: a significant increase in plasma ET-1 ( P  = 0.008) and a marginally significant decrease in nitrotyrosine ( P  = 0.017). Lastly, ozone exposure did not affect the primary prothrombotic endpoints (MP-TFA and monocyte-platelet conjugate count) or any secondary markers of prothrombotic vascular status (platelet activation, circulating microparticles [MPs], von Willebrand factor [vWF], or fibrinogen.).
Although our hypothesis focused on possible acute cardiovascular effects of exposure to low levels of ozone, we recognized that the initial effects of inhaled ozone involve the lower airways. Therefore, we looked for: (a) changes in lung function, which are known to occur during exposure to ozone and are maximal at the end of exposure; and (b) markers of airway injury and inflammation. We found an increase in forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV₁) after exposure to 0 ppb ozone, likely due to the effects of exercise. The FEV₁ increased significantly 15 minutes after 0 ppb exposure (85 mL; 95% confidence interval [CI], 64 to 106;  P  < 0.001), and remained significantly increased from pre-exposure at 22 hours (45 mL; 95% CI, 26 to 64;  P  < 0.001). The increase in FVC followed a similar pattern. The increase in FEV₁ and FVC were attenuated in a dose-response manner by exposure to 70 and 120 ppb ozone. We also observed a significant ozone-induced increase in the percentage of sputum PMN 22 hours after exposure at 120 ppb compared to 0 ppb exposure ( P  = 0.003). Plasma CC16 also increased significantly after exposure to 120 ppb ( P  < 0.001). Sputum IL-6, IL-8, and TNF-α concentrations were not significantly different after ozone exposure. We found no significant interactions with sex, age, or GSTM1 status regarding the effect of ozone on lung function, percentage of sputum PMN, or plasma CC16.
CONCLUSIONS


In this multicenter clinical study of older healthy subjects, ozone exposure caused concentration-related reductions in lung function and presented evidence for airway inflammation and injury. However, there was no convincing evidence for effects on cardiovascular function. Blood levels of the potent vasoconstrictor, ET-1, increased with ozone exposure (with marginal statistical significance), but there were no effects on BP, FMD, or other markers of vascular function. Blood levels of nitrotyrosine decreased with ozone exposure, the opposite of our hypothesis. Our study does not support acute cardiovascular effects of low-level ozone exposure in healthy older subjects. Inclusion of only healthy older individuals is a major limitation, which may affect the generalizability of our findings. We cannot exclude the possibility of effects with higher ozone exposure concentrations or more prolonged exposure, or the possibility that subjects with underlying vascular disease, such as hypertension or diabetes, would show effects under these conditions.",2017,"We found no significant effects of ozone exposure on any of the primary or secondary endpoints for autonomic function, repolarization, ST segment change, or arrhythmia.","['healthy older individuals', 'healthy older subjects', 'The mean age was 59.9 ± 4.5\xa0years, 60% of the subjects were female, 88% were white, and 57% were GSTM1 null', 'Healthy volunteers 55 to 70\xa0years of age were recruited', 'three clinical centers with a separate Data Coordinating and Analysis Center (DCAC) using a common protocol', 'Consented participants who successfully completed the screening and training sessions were enrolled in the study', 'oldEr Subjects (MOSES', 'A total of 87\xa0subjects completed all three exposures', 'older healthy subjects']","['ppb ozone (clean air), 70\xa0ppb ozone, and 120\xa0ppm ozone, alternating 15\xa0minutes of moderate exercise with 15\xa0minutes of rest']","['Mean baseline body mass index (BMI), BP, cholesterol (total and low-density lipoprotein), and lung function', 'FEV₁ and FVC', 'autonomic function, repolarization, ST segment change, or arrhythmia', 'total cardiovascular mortality and morbidity', 'systemic inflammation (CRP) and vascular function (systolic blood pressure [SBP] and FMD) or secondary endpoints for systemic inflammation and oxidative stress (IL-6, P-selectin, and 8-isoprostane', 'cardiovascular function', 'Blood levels of nitrotyrosine', 'FEV₁', 'BP, FMD, or other markers of vascular function', 'arrhythmias, endothelial dysfunction, acute arterial vasoconstriction, and procoagulant activity', 'Plasma CC16', 'forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV₁', 'primary prothrombotic endpoints (MP-TFA and monocyte-platelet conjugate count) or any secondary markers of prothrombotic vascular status (platelet activation, circulating microparticles [MPs], von Willebrand factor [vWF], or fibrinogen', 'Respiratory and Cardiovascular Outcomes', 'lung function, percentage of sputum PMN, or plasma CC16', 'electrocardiographic changes (continuous Holter monitoring: heart rate variability [HRV], repolarization, and arrhythmia); (2)\xa0markers of inflammation and oxidative stress (C-reactive protein [CRP], interleukin-6 [IL-6], 8-isoprostane, nitrotyrosine, and P-selectin); (3)\xa0vascular function measures (blood pressure [BP], flow-mediated dilatation [FMD] of the brachial artery, and endothelin-1 [ET-1]; (4)\xa0venous blood markers of platelet activation, thrombosis, and microparticle-associated tissue factor activity (MP-TFA); (5)\xa0pulmonary function (spirometry); (6)\xa0markers of airway epithelial cell injury (increases in plasma club cell protein 16 [CC16] and sputum total protein); and (7)\xa0markers of lung inflammation in sputum (polymorphonuclear leukocytes [PMN], IL-6, interleukin-8 [IL-8], and tumor necrosis factor-alpha [TNF-α', 'Blood levels', 'systemic oxidative stress and lung effects', 'percentage of sputum PMN', 'FVC', 'Sputum IL-6, IL-8, and TNF-α concentrations', 'nitrotyrosine', 'plasma ET-1']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0456148', 'cui_str': 'Null (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0032441', 'cui_str': 'Polybromobiphenyl Compounds'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0429029', 'cui_str': 'ST segment (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0134835', 'cui_str': 'Platelet alpha-Granule Membrane Protein'}, {'cui': 'C0295541', 'cui_str': '8-isoprostaglandin F2alpha'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0047645', 'cui_str': 'nitrotyrosine'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C1456863', 'cui_str': 'Vasoconstriction'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0032173', 'cui_str': 'Platelet Activation'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0013801', 'cui_str': 'Monitoring, Holter'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0229667', 'cui_str': 'VB - Venous blood'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0040048', 'cui_str': 'Prothrombinase'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0014597', 'cui_str': 'Epithelial Cells'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0472837,"We found no significant effects of ozone exposure on any of the primary or secondary endpoints for autonomic function, repolarization, ST segment change, or arrhythmia.","[{'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Frampton', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Balmes', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Bromberg', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stark', 'Affiliation': 'New England Research Institute, Watertown, Massachusetts.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arjomandi', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Hazucha', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'D Q', 'Initials': 'DQ', 'LastName': 'Rich', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hollenbeck-Pringle', 'Affiliation': 'New England Research Institute, Watertown, Massachusetts.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Dagincourt', 'Affiliation': 'New England Research Institute, Watertown, Massachusetts.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Alexis', 'Affiliation': 'University of North Carolina, Chapel Hill.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ganz', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zareba', 'Affiliation': 'University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Costantini', 'Affiliation': 'Health Effects Institute, Boston, Massachusetts.'}]",Research report (Health Effects Institute),[]
629,31831073,Protocol for a partially nested randomized controlled trial to evaluate the effectiveness of the Scleroderma Patient-centered Intervention Network Support Group Leader EDucation (SPIN-SSLED) Program.,"BACKGROUND


Some people with rare diseases rely on peer-led support groups for disease-specific education and emotional and practical support. Systemic sclerosis (SSc), or scleroderma, is a rare autoimmune connective tissue disease. Many people with SSc cannot access support groups, and, when support groups exist, they may not be sustained due to challenges that could be addressed via leader training. The Scleroderma Patient-centered Intervention Network (SPIN), along with SSc patient organization partners, developed a training program for SSc patient support group leaders, the Scleroderma Support group Leader EDucation (SPIN-SSLED) Program. We recently completed a feasibility trial in which we successfully delivered the program to two groups of support group leaders who reported a high level of satisfaction with the program and its delivery. The primary objective of the full-scale SPIN-SSLED trial is to evaluate the effect of the program on support group leaders' self-efficacy for carrying out their leadership role. Secondary objectives include evaluating effects on leader burnout, leader satisfaction (participation efficacy), and emotional distress.
METHODS/DESIGN


The SPIN-SSLED trial is a pragmatic randomized controlled trial (RCT) in which 180 support group leaders will be randomly allocated to training groups of 6 participants each or to a waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups, but not in the waitlist control. Participants allocated to the training program will receive the 13-module SPIN-SSLED Program, delivered via webinar over the course of 3 months in weekly 60-90-min sessions. The primary outcome is leader self-efficacy, measured by the Scleroderma Support Group Leader Self-efficacy Scale post-intervention. Secondary outcomes are leader self-efficacy at 3 months post-intervention, and leader burnout, volunteer job satisfaction (participation efficacy), and emotional distress post-intervention and at 3 months post-intervention.
DISCUSSION


The SPIN-SSLED trial will test whether a training program for SSc patient support group leaders increases the self-efficacy of group leaders to carry out leadership tasks. The program has the potential to significantly improve the effectiveness and sustainability of existing SSc support groups, to increase the number of available support groups, and to be adapted for other chronic diseases.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03965780. Registered on 29 May 2019.",2019,"The program has the potential to significantly improve the effectiveness and sustainability of existing SSc support groups, to increase the number of available support groups, and to be adapted for other chronic diseases.
",[],"['training program will receive the 13-module SPIN-SSLED Program', 'Scleroderma Support group Leader EDucation (SPIN-SSLED) Program', 'Scleroderma Patient-centered Intervention Network Support Group Leader EDucation (SPIN-SSLED) Program']","['leader self-efficacy, measured by the Scleroderma Support Group Leader Self-efficacy Scale post-intervention', 'leader burnout, leader satisfaction (participation efficacy), and emotional distress', 'leader self-efficacy at 3\u2009months post-intervention, and leader burnout, volunteer job satisfaction (participation efficacy), and emotional distress post-intervention', 'self-efficacy']",[],"[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0011644', 'cui_str': 'Dermatosclerosis'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011644', 'cui_str': 'Dermatosclerosis'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0222045'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}]",180.0,0.0808244,"The program has the potential to significantly improve the effectiveness and sustainability of existing SSc support groups, to increase the number of available support groups, and to be adapted for other chronic diseases.
","[{'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada. brett.thombs@mcgill.ca.'}, {'ForeName': 'Kylene', 'Initials': 'K', 'LastName': 'Aguila', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dyas', 'Affiliation': 'Scleroderma Foundation Michigan Chapter, Southfield, MI, USA.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Carrier', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Fedoruk', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Horwood', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Cañedo-Ayala', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sauvé', 'Affiliation': 'Scleroderma Society of Ontario and Scleroderma Canada, Hamilton, ON, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kwakkenbos', 'Affiliation': 'Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Malcarne', 'Affiliation': 'Department of Psychology, San Diego State University, California, USA.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'El-Baalbaki', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Peláez', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Kerri', 'Initials': 'K', 'LastName': 'Connolly', 'Affiliation': 'Scleroderma Foundation, Danvers, MA, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hudson', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Platt', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, QC, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3747-z']
630,31831080,Retraining automatic action tendencies for smoking using mobile phone-based approach-avoidance bias training: A study protocol for a randomized controlled study.,"BACKGROUND


Automatic tendencies to approach drug-related cues have been linked to the development and maintainance of harmful drug-taking behavior. Recent studies have demonstrated that these automatic approach tendencies can be targeted directly by means of cognitive bias modification (CBM). Moreover, changing those approach tendencies may enhance treatment outcomes. However, training and therapy effects tend to be rather small and adherence to the training might be impaired by time-consuming multiple laboratory training sessions. Here, we present a protocol for a randomized controlled design to improve CBM training efficiency and facilitate access to the training by providing mobile-phone-based training sessions at home to current smokers motivated to quit smoking.
METHODS


Participants (n = 100) are current smokers who smoke at least six cigarettes per day for at least 6 months and are willing to quit smoking. All participants attend a brief behavioral smoking cessation intervention (TAU) and are randomly assigned either to an experimental (TAU + training) or a control group. Participants in the experimental condition are given access to a training application (app) aimed at retraining automatic approach biases for smoking cues. Participants are instructed to perform the app training outside the laboratory context on a daily basis for 14 consecutive days. Participants in the control group do not receive the training. Primary outcome measures are changes in smoking-related approach biases and reductions in daily nicotine consumption as assessed at baseline, post-training and at 6-week follow up. Secondary outcome measures include approach biases for alternative stimuli or smoking stimuli to which participants were not exposed during training, attentional and association biases, biochemical outcomes, and self-reported smoking behavior, also measured at three different time points (baseline, post-training, and follow up). After completion of the study, smokers in the control condition will receive access to the training app.
DISCUSSION


This randomized controlled trial is the first to test the effectiveness of an app-based CBM intervention as an adjunct to a brief smoking cessation intervention in smokers motivated to quit smoking. The results of this study can inform future research in the optimization and advancement of CBM treatment for addiction.
TRIAL REGISTRATION


Current Controlled Trials, ISRCTN15690771. Registered on 20 November 2018.",2019,This randomized controlled trial is the first to test the effectiveness of an app-based CBM intervention as an adjunct to a brief smoking cessation intervention in smokers motivated to quit smoking.,"['Participants (n\u2009=\u2009100) are current smokers who smoke at least six cigarettes per day for at least 6\u2009months and are willing to quit smoking', 'smokers motivated to quit smoking']","['training by providing mobile-phone-based training sessions', 'Retraining automatic action tendencies for smoking using mobile phone-based approach-avoidance bias training', 'app-based CBM intervention', 'training application (app) aimed at retraining automatic approach biases for smoking cues', 'behavioral smoking cessation intervention (TAU', 'experimental (TAU + training) or a control group']","['approach biases for alternative stimuli or smoking stimuli to which participants were not exposed during training, attentional and association biases, biochemical outcomes, and self-reported smoking behavior', 'CBM training efficiency', 'changes in smoking-related approach biases and reductions in daily nicotine consumption']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3241966'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1519383', 'cui_str': 'Smoking Behaviors'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0391157,This randomized controlled trial is the first to test the effectiveness of an app-based CBM intervention as an adjunct to a brief smoking cessation intervention in smokers motivated to quit smoking.,"[{'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Machulska', 'Affiliation': 'Department of Clinical Psychology, University of Siegen, Adolf-Reichwein-Str. 2a, 57068, Siegen, Germany. alla.machulsk@uni-siegen.de.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Kleinke', 'Affiliation': 'Department of Clinical Psychology, University of Siegen, Adolf-Reichwein-Str. 2a, 57068, Siegen, Germany.'}, {'ForeName': 'Tanja Joan', 'Initials': 'TJ', 'LastName': 'Eiler', 'Affiliation': 'Department of Medical Informatics und Microsystems Engineering, University of Siegen, Siegen, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Grünewald', 'Affiliation': 'Department of Medical Informatics und Microsystems Engineering, University of Siegen, Siegen, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Brück', 'Affiliation': 'Department of Medical Informatics und Microsystems Engineering, University of Siegen, Siegen, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Jahn', 'Affiliation': 'Department of Business Informatics, University of Siegen, Siegen, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Niehaves', 'Affiliation': 'Department of Business Informatics, University of Siegen, Siegen, Germany.'}, {'ForeName': 'Carl Friedrich', 'Initials': 'CF', 'LastName': 'Gethmann', 'Affiliation': 'Research College FoKoS, University of Siegen, Siegen, Germany.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Klucken', 'Affiliation': 'Department of Clinical Psychology, University of Siegen, Adolf-Reichwein-Str. 2a, 57068, Siegen, Germany.'}]",Trials,['10.1186/s13063-019-3835-0']
631,30591358,Dietary Sodium Reduction Reduces Albuminuria: A Cluster Randomized Trial.,"OBJECTIVES


The objective of the study was to assess the impact of sustained dietary salt reduction on albuminuria in nearly 2000 community-dwelling adults.
DESIGN AND METHODS


The present study is a prespecified secondary analysis of the China Rural Health Initiative Salt Reduction Study cluster randomized trial undertaken in 120 villages in rural China. Villages were randomized to a sodium reduction program of education and access to reduced-sodium salt substitute or control. Urinary albumin-to-creatinine ratio (uACR) and albuminuria (uACR ≥22.1 or 31.0 mg/g for men and women, respectively) were assessed at 18 months in a stratified random sample of predominantly older individuals living in participating rural villages.
RESULTS


A total of 2,566 participants from 119 villages provided 1,903 eligible urine samples. The sodium reduction program reduced sodium intake by an equivalent of 0.82g of salt/day (0.06-1.68 g) (322 [24-661] mg sodium/day). The mean uACR was 8.85 (8.05-9.82) mg/g (1.00 [0.91-1.11] mg/mmol) in intervention participants compared with 10.53 (9.73-11.33) mg/g (1.19 [1.10-1.28] mg/mmol) in control participants (p=0.008). The corresponding odds ratio for albuminuria was 0.67 (0.46-0.99).
CONCLUSIONS


Dietary sodium reduction was associated with significantly lower uACR and less albuminuria after 18 months. Whether CKD progression can be slowed by dietary sodium reduction should be a global research priority. CLINICALTRIALS.GOV: NCT01259700.",2019,"Urinary albumin-to-creatinine ratio (uACR) and albuminuria (uACR ≥22.1 or 31.0 mg/g for men and women, respectively) were assessed at 18 months in a stratified random sample of predominantly older individuals living in participating rural villages.
","['men and women, respectively) were assessed at 18 months in a stratified random sample of predominantly older individuals living in participating rural villages', '120 villages in rural China', '2,566 participants from 119 villages provided 1,903 eligible urine samples', 'nearly 2000 community-dwelling adults']","['Dietary Sodium Reduction', 'sodium reduction program of education and access to reduced-sodium salt substitute or control', 'sustained dietary salt reduction']","['Albuminuria', 'sodium intake', 'Urinary albumin-to-creatinine ratio (uACR) and albuminuria', 'mean uACR', 'corresponding odds ratio for albuminuria']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0037570', 'cui_str': 'Sodium, Dietary'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0351302', 'cui_str': 'Sodium salts (substance)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036140', 'cui_str': 'Salts'}]","[{'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}]",2566.0,0.0789776,"Urinary albumin-to-creatinine ratio (uACR) and albuminuria (uACR ≥22.1 or 31.0 mg/g for men and women, respectively) were assessed at 18 months in a stratified random sample of predominantly older individuals living in participating rural villages.
","[{'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, Australia; Concord Repatriation General Hospital, Sydney, Australia. Electronic address: mjardine@georgeinstitute.org.au.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, Australia; The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Toshiharu', 'Initials': 'T', 'LastName': 'Ninomiya', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, Australia; Center for Cohort Studies, Graduate School of Medical Sciences, Kyushu University, Fukuok, Japan.'}, {'ForeName': 'Xiangxian', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Changzhi Medical College, Changzhi, Shanxi, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Hebei Province Center for Disease Prevention and Control, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Jingpu', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'First Hospital of China Medical University, Liaoning, China.'}, {'ForeName': 'Yuhong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Ningxia Medical University, Yinchuan, Ningxia, China.'}, {'ForeName': 'Ruijuan', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Hao', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, Australia.'}, {'ForeName': 'Hiddo L', 'Initials': 'HL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center, Groningen, University of Groningen, Netherlands.'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China; Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing, China; Peking University Clinical Research Institute, Beijing, China.'}, {'ForeName': 'Lijing L', 'Initials': 'LL', 'LastName': 'Yan', 'Affiliation': 'The George Institute for Global Health at Peking University Health Science Center, Beijing, China; Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois; Global Health Research Center, Duke Kunshan University, Kunshan, China.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, Australia.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2018.10.009']
632,31870605,"Reducing Tobacco Smoke Exposure in High-Risk Infants: A Randomized, Controlled Trial.","OBJECTIVE


To evaluate a hospital-initiated intervention to reduce tobacco smoke exposure in infants in the neonatal intensive care unit.
STUDY DESIGN


A randomized, controlled trial compared motivational interviewing plus financial incentives with conventional care on infant urine cotinine at 1 and 4 months' follow-up. Mothers of infants in the neonatal intensive care unit (N = 360) who reported a smoker living in the home were enrolled. Motivational interviewing sessions were delivered in both the hospital and the home. Financial incentives followed session attendance and negative infant cotinine tests postdischarge.
RESULTS


The intervention effect on infant cotinine was not significant, except among mothers who reported high baseline readiness/ability to protect their infant (P ≤ .01) and mothers who completed the study within 6 months postdischarge (per protocol; P ≤ .05). Fewer mothers in the motivational interviewing plus financial incentives condition were smoking postdischarge (P ≤ .01). More mothers in the motivational interviewing plus financial incentives group reported a total home and car smoking ban at follow-up (P ≤ .05).
CONCLUSIONS


Motivational interviewing combined with financial incentives reduced infant tobacco smoke exposure in a subset of women who were ready/able to protect their infant. The intervention also resulted in less maternal smoking postpartum. More robust interventions that include maternal and partner/household smoking cessation are likely needed to reduce the costly effects of tobacco smoke exposure on children and their families.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT01726062.",2020,Fewer mothers in the motivational interviewing plus financial incentives condition were smoking postdischarge (P ≤ .01).,"['Mothers of infants in the neonatal intensive care unit (N\xa0=\xa0360) who reported a smoker living in the home were enrolled', 'infants in the neonatal intensive care unit', 'High-Risk Infants']","['motivational interviewing plus financial incentives with conventional care', 'Motivational interviewing sessions', 'Motivational interviewing combined with financial incentives']","['infant cotinine', 'total home and car smoking', 'infant tobacco smoke exposure', 'maternal smoking postpartum', 'smoking postdischarge']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0419437', 'cui_str': 'High risk infant (finding)'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0004381', 'cui_str': 'Automobiles'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke (substance)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}]",,0.104123,Fewer mothers in the motivational interviewing plus financial incentives condition were smoking postdischarge (P ≤ .01).,"[{'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Stotts', 'Affiliation': 'Department of Family and Community Medicine, McGovern Medical School at UTHealth, Houston, TX.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Northrup', 'Affiliation': 'Department of Family and Community Medicine, McGovern Medical School at UTHealth, Houston, TX.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at UTHealth, Houston, TX.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Suchting', 'Affiliation': 'Department of Psychiatry and Behavioral Science, McGovern Medical School at UTHealth, Houston, TX.'}, {'ForeName': 'Melbourne F', 'Initials': 'MF', 'LastName': 'Hovell', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, School of Public Health, San Diego State University, San Diego, CA.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at UTHealth, Houston, TX.'}, {'ForeName': 'Yolanda R', 'Initials': 'YR', 'LastName': 'Villarreal', 'Affiliation': 'Department of Family and Community Medicine, McGovern Medical School at UTHealth, Houston, TX.'}, {'ForeName': 'Joy M', 'Initials': 'JM', 'LastName': 'Schmitz', 'Affiliation': 'Department of Psychiatry and Behavioral Science, McGovern Medical School at UTHealth, Houston, TX.'}, {'ForeName': 'Mary M', 'Initials': 'MM', 'LastName': 'Velasquez', 'Affiliation': 'School of Social Work, University of Texas, Austin, TX.'}, {'ForeName': 'S Katharine', 'Initials': 'SK', 'LastName': 'Hammond', 'Affiliation': 'Division of Environmental Health, School of Public Health, University of California, Berkeley, CA.'}, {'ForeName': 'Eunha', 'Initials': 'E', 'LastName': 'Hoh', 'Affiliation': 'Division of Environmental Health, School of Public Health, San Diego State University, San Diego, CA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Tyson', 'Affiliation': 'Department of Pediatrics, McGovern Medical School at UTHealth, Houston, TX.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.10.070']
633,31857014,Left Ventricular Rapid Pacing Via the Valve Delivery Guidewire in Transcatheter Aortic Valve Replacement.,"OBJECTIVES


This study investigated whether left ventricular (LV) stimulation via a guidewire-reduced procedure duration while maintaining efficacy and safety compared with standard right ventricular (RV) stimulation.
BACKGROUND


Rapid ventricular pacing is necessary to ensure cardiac standstill during transcatheter aortic valve replacement (TAVR).
METHODS


This is a prospective, multicenter, single-blinded, superiority, randomized controlled trial. Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California) were allocated to LV or RV stimulation. The primary endpoint was procedure duration. Secondary endpoints included efficacy, safety, and cost at 30 days.
RESULTS


Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n = 151) or RV (n = 152) stimulation groups. Mean procedure duration was significantly shorter in the LV stimulation group (48.4 ± 16.9 min vs. 55.6 ± 26.9 min; p = 0.0013), with a difference of -0.12 (95% confidence interval: -0.20 to -0.05) in the log-transformed procedure duration (p = 0.0012). Effective stimulation was similar in the LV and RV stimulation groups: 124 (84.9%) versus 128 (87.1%) (p = 0.60). Safety of stimulation was also similar in the LV and RV stimulation groups: procedural success occurred in 151 (100%) versus 151 (99.3%) patients (p = 0.99); 30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement) occurred in 21 (13.9%) versus 26 (17.1%) patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = 0.001).
CONCLUSIONS


Compared with RV stimulation, LV stimulation during TAVR was associated with significantly reduced procedure duration, fluoroscopy time, and cost, with similar efficacy and safety. (Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVR [EASY TAVI]; NCT02781896).",2019,"patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = ","['Patients undergoing transfemoral TAVR with a SAPIEN valve (Edwards Lifesciences, Irvine, California', 'Between May 2017 and May 2018, 307 patients were randomized, but 4 were excluded because they did not receive the intended treatment: 303 patients were analyzed in the LV (n\xa0=\xa0151) or RV (n\xa0=\xa0152) stimulation groups']","['standard right ventricular (RV) stimulation', 'Left Ventricular Rapid Pacing Via', 'LV or RV stimulation', 'Transcatheter Aortic Valve Replacement', 'Via\xa0the Valve Delivery Guide-wire in TAVR', 'left ventricular (LV) stimulation via a guidewire-reduced procedure duration']","['procedural success', 'efficacy, safety, and cost at 30\xa0days', 'procedure duration', '30-day MACE-TAVR (major adverse cardiovascular event-transcatheter aortic valve replacement', 'fluoroscopy time', 'Safety of stimulation', 'procedure duration, fluoroscopy time, and cost, with similar efficacy and safety', 'Effective stimulation', 'Mean procedure duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0181089', 'cui_str': 'Catheter guide wire'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",307.0,0.147618,"patients (p = 0.44); fluoroscopy time (min) was lower in the LV stimulation group (13.48 ± 5.98 vs. 14.60 ± 5.59; p = 0.02), as was cost (€18,807 ± 1,318 vs. €19,437 ± 2,318; p = ","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Faurie', 'Affiliation': 'Institut Cardiovasculaire, Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France; Cardiology Department, Médipole HP Lyon-Villeurbane, Villeurbane, France. Electronic address: faurieb@gmail.com.'}, {'ForeName': 'Géraud', 'Initials': 'G', 'LastName': 'Souteyrand', 'Affiliation': 'Cardiology Department, Centre Hospitalier Universitaire Gabriel-Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Staat', 'Affiliation': 'Cardiology Department, Médipole HP Lyon-Villeurbane, Villeurbane, France.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Godin', 'Affiliation': 'Cardiology Department, Clinique Saint Hilaire, Rouen, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Caussin', 'Affiliation': 'Cardiology Department, Institut Mutualiste Montsouris, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Belle', 'Affiliation': 'Département de cardiologie, Institut Cœur Poumon, Centre Hospitalier Universitaire de Lille, Lille, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Mangin', 'Affiliation': 'Cardiology Department, Centre Hospitalier Annecy Genevois, Epagny, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Meyer', 'Affiliation': 'Cardiology Department, Institut Arnault Tzanck, Saint-Laurent-du-Var, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dumonteil', 'Affiliation': 'Cardiology Department, Clinique Pasteur, Toulouse, France.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdellaoui', 'Affiliation': 'Institut Cardiovasculaire, Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France; Cardiology Department, Médipole HP Lyon-Villeurbane, Villeurbane, France.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Monségu', 'Affiliation': 'Institut Cardiovasculaire, Groupe Hospitalier Mutualiste de Grenoble, Grenoble, France; Cardiology Department, Médipole HP Lyon-Villeurbane, Villeurbane, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': ""Cardiology Department, URC-Eco Île de France, Hôpital de l'Hôtel Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France.""}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lefèvre', 'Affiliation': 'Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.09.029']
634,31880956,Fundamentals of randomized designs: AMEE Guide No. 128.,"This AMEE Guide summarizes fundamentals of a major experimental design option for medical education researchers: the randomised study. Medical education researchers face an overwhelming taxonomy of study design options; given the breadth of information on experimental design, the purpose of this Guide is to offer a resource for medical education researchers wishing to equip themselves with helpful information for when to match a study's objective and the use of randomised designs. Once a research question has been formulated study design is the cornerstone of the intricate, nested activities of any research project. Researchers negotiate many decisions in the pursuit of choosing an appropriate design approach; failure to do so can undermine a project's capacity to, for example, sufficiently test a hypothesis or theory. Written as an introduction, this Guide is intended for medical education researchers seeking to build on and synthesise the existing corpus of literature on experimental and quasi-experimental design approaches. While not comprehensive, presented are key concepts alongside relevant examples from the field of health professions education.",2020,"Written as an introduction, this Guide is intended for medical education researchers seeking to build on and synthesise the existing corpus of literature on experimental and quasi-experimental design approaches.",[],[],[],[],[],[],,0.0254372,"Written as an introduction, this Guide is intended for medical education researchers seeking to build on and synthesise the existing corpus of literature on experimental and quasi-experimental design approaches.","[{'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Horsley', 'Affiliation': 'PhD Research Unit, Royal College of Physicians and Surgeons of Canada, Ottawa, Canada.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Custers', 'Affiliation': 'PhD Research Unit, Royal College of Physicians and Surgeons of Canada, Ottawa, Canada.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Tolsgaard', 'Affiliation': 'PhD Research Unit, Royal College of Physicians and Surgeons of Canada, Ottawa, Canada.'}]",Medical teacher,['10.1080/0142159X.2019.1681389']
635,31880993,Effect of Oyster Meat Preload on Postmeal Glycemic Control in Healthy Young Adults.,"Objective:  Evidence suggests that food preload improves postmeal glycemic profiles, but the effects of marine food are poorly understood. Our study aims to verify the regulating effects of premeal oyster meat (OM) on postprandial blood glucose. Method:  Edible parts of the flesh of oyster were prepared for a randomized crossover experiment. After overnight fasting, 20 healthy young men consumed 300 mL of preload drinks with 0 g/kg body weight (BW) (control), 0.1 g/kg BW, and 0.2 g/kg BW. Peripheral blood concentrations of glucose and gastrointestinal hormones were measured before preloading at baseline (0 minutes) and at intervals after the preload and after a preset rice meal. The nutrient composition of OM was analyzed. Results:  Compared with other doses, 0.2 g/kg BW OM preload induced higher plasma premeal insulin ( p  < 0.05), C-peptide ( p  < 0.05), and glucagon-like peptide-1 (GLP-1;  p  < 0.05) without altering the glucose concentrations during premeal times. By contrast, 0.2 g/kg BW OM induced less secretion of glucose ( p  < 0.05) and gastric inhibitory peptide (GIP;  p  < 0.05), but higher secretion of GLP-1 ( p  < 0.05) than 0.1 g/kg BW of OM after a meal. During the entire experiment (0-170 minutes), OM reduced the blood glucose ( p  < 0.05) and GIP ( p  < 0.05), but increased GLP-1 ( p  < 0.05). OM was rich in protein (78.4%) and low in fat (6%). Glutamic acid, aspartic acids, glycine, and taurine are the amino acids with high content found in OM. Conclusions:  OM preload reduces postmeal glycemia in healthy young people with associated changes in gastrointestinal hormone responses. This effect may be attributed to the rich contents of protein and amino acids of OM.",2020,"During the entire experiment (0-170 minutes), OM reduced the blood glucose ( p  < 0.05) and GIP ( p  < 0.05), but increased GLP-1 ( p  < 0.05).","['Healthy Young Adults', 'healthy young people', '20 healthy young men']","['Oyster Meat Preload', 'premeal oyster meat (OM', 'consumed 300\u2009mL of preload drinks', 'OM', 'OM preload']","['GLP-1', 'Postmeal Glycemic Control', 'gastrointestinal hormone responses', 'plasma premeal insulin', 'postprandial blood glucose', 'gastric inhibitory peptide', 'blood glucose', 'Peripheral blood concentrations of glucose and gastrointestinal hormones', 'nutrient composition of OM', 'postmeal glycemic profiles', 'higher secretion of GLP-1', 'postmeal glycemia', 'glucagon-like peptide-1', 'glucose concentrations', 'secretion of glucose']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0030104', 'cui_str': 'Ostreidae'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0017182', 'cui_str': 'Gastrointestinal Hormones'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0017132', 'cui_str': 'Glucose-Dependent Insulin-Releasing Peptide'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}]",20.0,0.0333024,"During the entire experiment (0-170 minutes), OM reduced the blood glucose ( p  < 0.05) and GIP ( p  < 0.05), but increased GLP-1 ( p  < 0.05).","[{'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Central Laboratory, The Second Affiliated Hospital of Xiamen Medical College, Xiamen, China.'}, {'ForeName': 'Gengxin', 'Initials': 'G', 'LastName': 'Hao', 'Affiliation': 'College of Food and Biological Engineering, Jimei University, Xiamen, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Lai', 'Affiliation': 'Central Laboratory, The Second Affiliated Hospital of Xiamen Medical College, Xiamen, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Central Laboratory, The Second Affiliated Hospital of Xiamen Medical College, Xiamen, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Long', 'Affiliation': 'Central Laboratory, The Second Affiliated Hospital of Xiamen Medical College, Xiamen, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Lai', 'Affiliation': 'Central Laboratory, The Second Affiliated Hospital of Xiamen Medical College, Xiamen, China.'}, {'ForeName': 'Yongmei', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'Central Laboratory, The Second Affiliated Hospital of Xiamen Medical College, Xiamen, China.'}, {'ForeName': 'Changfu', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Central Laboratory, The Second Affiliated Hospital of Xiamen Medical College, Xiamen, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zang', 'Affiliation': 'Central Laboratory, The Second Affiliated Hospital of Xiamen Medical College, Xiamen, China.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2019.1699475']
636,31847908,"Topical sirolimus 0.1% for treating cutaneous microcystic lymphatic malformations in children and adults (TOPICAL): protocol for a multicenter phase 2, within-person, randomized, double-blind, vehicle-controlled clinical trial.","BACKGROUND


Cutaneous microcystic lymphatic malformations (CMLMs) are rare conditions in children and adults. They present as clusters of vesicles full of lymph and blood to various extents, inducing maceration, esthetic impairment, pain, and impaired quality of life. The treatment is challenging. Sirolimus is an inhibitor of mammalian target of rapamycin (mTOR) involved in angio-lymphangiogenesis. Topical sirolimus has recently been reported as effective in a few reports of patients with CMLMs. The objective is to compare the efficacy and safety of a 12-week application of 0.1% topical sirolimus versus topical vehicle in CMLMs in children and adults.
METHODS


This French blinded multicenter within-person randomized controlled phase 2 trial aims to include 55 patients aged ≥ 6 years who have a primary CMLM. The CMLM will be divided into two equal areas that will be randomly allocated to 0.1% topical sirolimus or topical vehicle applied for 12 weeks. At the end of the 12-week period, the patient/parent will treat the whole area of CMLM with 0.1% topical sirolimus on remaining lesions, for eight more weeks. Patients will be seen at week 20 (treatment will be stopped) and at month 12 to evaluate long-term efficacy. The primary outcome will be improvement of the CMLM in the area treated with topical sirolimus compared to the area treated with topical vehicle by the investigator physician (blinded to the treatment) with the Physician Global Assessment score at week 12. Secondary outcomes will include: assessment of efficacy by independent experts on the basis of standardized photographs; impact on quality of life; efficacy for oozing, bleeding, erythema, and thickness evaluated by the investigators; and global efficacy as well as efficacy for functional and aesthetic impairment evaluated by the patient. Systemic passage of sirolimus will be measured at weeks 6, 12, and 20, and at week 16 for CMLMs ≥ 900 cm 2 .
DISCUSSION


For patients with CMLMs, topical sirolimus could be a non-invasive and well-tolerated therapeutic option. If the trial demonstrates efficacy and safety of this treatment, this result will lead to a real change in the management of this condition, and 0.1% sirolimus cream would become the first-line treatment.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03972592. Registered on 3 June 2019. EU Clinical Trials Register EudraCT, 2018-001359-11.",2019,The primary outcome will be improvement of the CMLM in the area treated with topical sirolimus compared to the area treated with topical vehicle by the investigator physician (blinded to the treatment) with the Physician Global Assessment score at week 12.,"['55 patients aged ≥\u20096\u2009years who have a primary CMLM', 'children and adults', 'children and adults (TOPICAL', 'patients with CMLMs']","['Sirolimus', 'Topical sirolimus', 'topical sirolimus', 'sirolimus cream']","[' assessment of efficacy by independent experts on the basis of standardized photographs; impact on quality of life; efficacy for oozing, bleeding, erythema, and thickness evaluated by the investigators; and global efficacy as well as efficacy for functional and aesthetic impairment', 'Systemic passage of sirolimus', 'Physician Global Assessment score', 'efficacy and safety', 'improvement of the CMLM', 'cutaneous microcystic lymphatic malformations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0398368', 'cui_str': 'Lymphatic Abnormalities'}]",55.0,0.15466,The primary outcome will be improvement of the CMLM in the area treated with topical sirolimus compared to the area treated with topical vehicle by the investigator physician (blinded to the treatment) with the Physician Global Assessment score at week 12.,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Leducq', 'Affiliation': 'INSERM U1246 -SPHERE « MethodS in Patients-centered outcomes and HEalth REsearch », University of Nantes, University of Tours, 37000, Tours, France. soleducq@gmail.com.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Caille', 'Affiliation': 'INSERM U1246 -SPHERE « MethodS in Patients-centered outcomes and HEalth REsearch », University of Nantes, University of Tours, 37000, Tours, France.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Barbarot', 'Affiliation': 'Department of Dermatology, University Hospital Center of Nantes, 44000, Nantes, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Bénéton', 'Affiliation': 'Department of Dermatology, Hospital Center of le Mans, 72037, le Mans, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Bessis', 'Affiliation': 'Department of Dermatology, University Hospital Center of Montpellier, 34000, Montpellier, France.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Boccara', 'Affiliation': 'Department of Dermatology and Reference center for genodermatoses and rare skin diseases (MAGEC), University Hospital Necker-Enfants Malades, 75015, Paris, France.'}, {'ForeName': 'Anne-Claire', 'Initials': 'AC', 'LastName': 'Bursztejn', 'Affiliation': 'Department of Dermatology, University Hospital Center of Nancy, 54000, Nancy, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Chiaverini', 'Affiliation': 'Department of Dermatology, University Hospital Center of Nice, 06000, Nice, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Dompmartin', 'Affiliation': 'Department of Dermatology, University Hospital Center of Caen, 54000, Caen, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Droitcourt', 'Affiliation': 'Department of Dermatology, University Hospital Center of Rennes, 35000, Rennes, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Gissot', 'Affiliation': 'Clinical Investigation Center, INSERM 1415, CHRU Tours, 37000, Tours, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Goga', 'Affiliation': 'Department of Maxillo-Facial surgery, CHRU Tours, 37044, Tours, Cedex 9, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Guibaud', 'Affiliation': 'University Hospital Center of Lyon, Consultation Multidisciplinaire Lyonnaise des Angiomes, 69229, Lyon, Cedex 2, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Herbreteau', 'Affiliation': 'Department of Neuroradiology, CHRU Tours, 37000, Tours, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Le Touze', 'Affiliation': 'Department of Pediatric Surgery, CHRU Tours, 37000, Tours, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Léauté-Labrèze', 'Affiliation': ""Department of Dematology, Pellegrin Children's Hospital, 33076, Bordeaux, France.""}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Lorette', 'Affiliation': 'Department of Dermatology and Reference Center for Rare Diseases and Vascular Malformations (MAGEC), CHRU Tours, Avenue de la République, 37044, Tours, Cedex 9, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Mallet', 'Affiliation': 'Department of Dermatology, University Hospital Center of Marseille, 13885, Marseille, Cedex 5, France.'}, {'ForeName': 'Ludovic', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Department of Dermatology, University Hospital Center of Angers, 49000, Angers, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Mazereeuw-Hautier', 'Affiliation': 'Reference center for rare skin diseases, Department of Dermatology, University Hospital Center of Toulouse, Paul Sabatier University, 31059, Toulouse, France.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Phan', 'Affiliation': 'Department of Dermatology, University Hospital Center of Lyon, 69229, Lyon, Cedex 2, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Plantin', 'Affiliation': 'Department of Dermatology, Hospital Center of Quimper, 29107, Quimper, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Quéré', 'Affiliation': 'Departement of Vascular Medicine, National Reference Centre for Rare Vascular Diseases, EA 2992 Research Team, University of Montpellier, University Hospital Center of Montpellier, 34000, Montpellier, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Vabres', 'Affiliation': 'Department of Dermatology, University Hospital Center of Dijon, 21000, Dijon, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Bourgoin', 'Affiliation': 'Department of Pharmacy, University Hospital Center of Tours, 37000, Tours, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': 'INSERM U1246 -SPHERE « MethodS in Patients-centered outcomes and HEalth REsearch », University of Nantes, University of Tours, 37000, Tours, France.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Maruani', 'Affiliation': 'INSERM U1246 -SPHERE « MethodS in Patients-centered outcomes and HEalth REsearch », University of Nantes, University of Tours, 37000, Tours, France. annabel.maruani@univ-tours.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3767-8']
637,31622643,"Ruxolitinib cream for the treatment of patients with alopecia areata: A 2-part, double-blind, randomized, vehicle-controlled phase 2 study.","BACKGROUND


There are currently no treatments for alopecia areata (AA) that are universally effective or approved by the US Food and Drug Administration. Oral ruxolitinib has shown efficacy in extensive AA. Ruxolitinib cream would potentially avoid systemic adverse effects.
OBJECTIVE


To assess the efficacy and safety of 1.5% ruxolitinib cream in patients with AA who had at least 25% hair loss by Severity of Alopecia Tool score.
METHODS


This was a 2-part study. Part A was an open-label, 24-week study of 1.5% ruxolitinib cream in patients with 25% to 99% hair loss followed by a 24-week extension period. Part B was a double-blind, vehicle-controlled, 24-week study of 1.5% ruxolitinib cream in patients with 25% to 100% hair loss, followed by a crossover to ruxolitinib cream in the vehicle group for 24 weeks and additional treatment time for the ruxolitinib cream group.
RESULTS


Although Part A results suggested potential efficacy of 1.5% ruxolitinib cream, there was no significant difference in hair regrowth based on 50% improvement in Severity of Alopecia Tool scores between patients receiving 1.5% ruxolitinib cream and vehicle in part B. There were no significant safety issues with 1.5% ruxolitinib cream.
LIMITATIONS


Single strength of ruxolitinib cream.
CONCLUSIONS


The 1.5% ruxolitinib cream did not have a significant effect in patients with AA.",2020,"Although Part A results suggested potential efficacy of 1.5% ruxolitinib cream, there was no significant difference in hair regrowth by SALT 50  scores between patients on 1.5% ruxolitinib cream and vehicle in Part B.","['patients with AA who had ≥25% hair loss by Severity of Alopecia Tool (SALT) score', 'patients with AA', 'Patients With Alopecia Areata', 'patients with 25%-99% hair loss followed by a 24-week extension period', 'patients with 25%-100% hair loss']","['ruxolitinib cream', 'Ruxolitinib Cream', 'ruxolitinib cream group', 'Ruxolitinib cream']","['efficacy and safety', 'hair regrowth']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0002171', 'cui_str': 'Alopecia Circumscripta'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018494', 'cui_str': 'Hair'}]",,0.0529731,"Although Part A results suggested potential efficacy of 1.5% ruxolitinib cream, there was no significant difference in hair regrowth by SALT 50  scores between patients on 1.5% ruxolitinib cream and vehicle in Part B.","[{'ForeName': 'Elise A', 'Initials': 'EA', 'LastName': 'Olsen', 'Affiliation': 'Department of Dermatology and Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Kornacki', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware. Electronic address: dkornacki@incyte.com.'}, {'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Sun', 'Affiliation': 'Incyte Corporation, Wilmington, Delaware.'}, {'ForeName': 'Maria K', 'Initials': 'MK', 'LastName': 'Hordinsky', 'Affiliation': 'Department of Dermatology, University of Minnesota, Minneapolis, Minnesota.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.10.016']
638,30982743,"High-Resistant Starch, Low-Protein Flour Intervention on Patients With Early Type 2 Diabetic Nephropathy: A Randomized Trial.","OBJECTIVE


The objective of this study is to explore the effect of high-resistant starch (RS), low-protein flour as a source of RS on patients with early type 2 diabetic nephropathy (DN) through the clinical intervention trial.
DESIGN


This was a single center, randomized, comparative, open-label trial. Seventy-five patients with early DN, aged 18 to 80 y, were recruited and randomly assigned to two groups. During the 12-week intervention, the control group patients (38 cases) followed protein-restriction diet daily with a common staple. The intervention group (37 cases) received 50 g of high-RS, low-protein flour instead of a common staple of equal quality at lunch and dinner each day. The blood glucose, blood lipids, nutritional parameters, indicators of renal function, oxidative stress, and inflammatory markers were measured.
RESULTS


Compared with the control group, high-RS, low-protein flour intake led to a significant reduction in fasting blood glucose, HbA1c, total cholesterol, and triglycerides levels (P < .05 for all). The changes in serum uric acid (UA) and β2-microglobulin (β2-MG) level were observed after high-RS, low-protein flour intervention (uric acid [mean ± standard deviation]: -24.7 ± 38.5 μmol/L, P = .001; β2-MG: 0.5 ± 0.9 mg/L, P = 0.018). In addition, high-RS, low-protein flour intake increased serum superoxide dismutase level by 10.1 ± 27.7 U/mL (P < .05); however, it did not change the interleukin-6 and Tumor Necrosis Factor α (TNF-α) concentration.
CONCLUSIONS


Twelve-week intervention with high-RS, low-protein flour improved the blood glucose and blood lipid levels, decreased the serum uric acid (UA) and urine β2-MG, and enhanced the ability to prevent antioxidative stress in patients with early DN.",2019,"(P < .05); however, it did not change the interleukin-6 and Tumor Necrosis Factor α (TNF-α) concentration.
","['patients with early DN', 'Patients With Early Type 2 Diabetic Nephropathy', 'patients with early type 2 diabetic nephropathy (DN', 'Seventy-five patients with early DN, aged 18 to 80\xa0y']","['protein-restriction diet daily with a common staple', '50 g of high-RS, low-protein flour instead of a common staple of equal quality at lunch and dinner each day', 'High-Resistant Starch, Low-Protein Flour Intervention', 'high-resistant starch (RS), low-protein flour']","['fasting blood glucose, HbA1c, total cholesterol, and triglycerides levels', 'serum uric acid (UA) and urine β2-MG', 'blood glucose, blood lipids, nutritional parameters, indicators of renal function, oxidative stress, and inflammatory markers', 'antioxidative stress', 'blood glucose and blood lipid levels', 'serum superoxide dismutase level', 'serum uric acid (UA) and β2-microglobulin (β2-MG) level', 'interleukin-6 and Tumor Necrosis Factor α (TNF-α) concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C1293124', 'cui_str': 'Stapling procedure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C4552592', 'cui_str': 'With dinner'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0038179', 'cui_str': 'Starch'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0455272', 'cui_str': 'Serum uric acid measurement'}, {'cui': 'C0042037'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0069638', 'cui_str': 'orgotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",75.0,0.0214878,"(P < .05); however, it did not change the interleukin-6 and Tumor Necrosis Factor α (TNF-α) concentration.
","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Meng', 'Affiliation': 'Department of Nutrition, Shandong Provincial Hospital, Jinan, China; Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Bai', 'Affiliation': ""The people's hospital of Huaiyin, Jinan, China.""}, {'ForeName': 'Qingtao', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': ""The people's hospital of Huaiyin, Jinan, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ""The people's hospital of Huaiyin, Jinan, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""The people's hospital of Huaiyin, Jinan, China.""}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China.'}, {'ForeName': 'Zhaoping', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, Shandong Provincial Hospital, Jinan, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition, Shandong Provincial Hospital, Jinan, China.'}, {'ForeName': 'Liyong', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Nutrition, Shandong Provincial Hospital, Jinan, China; Department of Nutrition and Food Hygiene, School of Public health, Shandong University, Jinan, China. Electronic address: chenle73@sina.com.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2018.12.005']
639,31609072,Avocatin B Protects Against Lipotoxicity and Improves Insulin Sensitivity in Diet-Induced Obesity.,"SCOPE


The effects of an avocado-derived fatty acid oxidation (FAO) inhibitor, avocatin B (AvoB), on glucose and lipid metabolism in models of diet-induced obesity (DIO) and in vitro models of lipotoxicity are evaluated. The safety of its oral consumption in humans is also determined.
METHODS AND RESULTS


Mice are given high-fat diets (HFD) for 8 weeks. Thereafter, AvoB or vehicle is administered orally twice weekly for 5 weeks. AvoB inhibits FAO which led to improved glucose tolerance, glucose utilization, and insulin sensitivity. AvoB's effects on metabolism under lipotoxic conditions are evaluated in vitro in pancreatic β-islet cells and C2C12 myotubes. AvoB inhibits FAO and increases glucose oxidation, resulting in lowering of mitochondrial reactive oxygen species that improves insulin responsiveness in C2C12 myotubes and insulin secretion in INS-1 (832/13) cells, respectively. A randomized, double-blind, placebo-controlled clinical trial in healthy human participants is conducted to assess the safety of AvoB consumption (50 mg or 200 mg per day for 60 days). AvoB is well-tolerated and not associated with any dose-limiting toxicity.
CONCLUSION


Therapeutic agents that are safe and effectively inhibit FAO and improve DIO-associated pathologies are currently not available. AvoB's mechanism of action and favorable safety profile highlight its nutritional and clinical importance.",2019,"AvoB inhibited FAO and increased glucose oxidation resulting in lowering of mitochondrial reactive oxygen species that improved insulin responsiveness in C2C12 myotubes and insulin secretion in INS-1 (832/13) cells, respectively.","['Mice were given high fat diets (HFD) for 8 weeks', 'healthy human participants']","['placebo', 'avocado-derived fatty acid oxidation (FAO) inhibitor, avocatin B (AvoB', 'AvoB consumption', 'Avocatin B Protects Against Lipotoxicity']","['Insulin Sensitivity', 'glucose oxidation', 'glucose tolerance, glucose utilization and insulin sensitivity']","[{'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0521974', 'cui_str': 'Diet, High-Fat'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0330230', 'cui_str': 'Avocado'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0042153', 'cui_str': 'use'}]",,0.126763,"AvoB inhibited FAO and increased glucose oxidation resulting in lowering of mitochondrial reactive oxygen species that improved insulin responsiveness in C2C12 myotubes and insulin secretion in INS-1 (832/13) cells, respectively.","[{'ForeName': 'Nawaz', 'Initials': 'N', 'LastName': 'Ahmed', 'Affiliation': 'Department of Food Science, University of Guelph, Guelph, Ontario, Canada, N1G 2W1.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Tcheng', 'Affiliation': 'Department of Food Science, University of Guelph, Guelph, Ontario, Canada, N1G 2W1.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Roma', 'Affiliation': 'Department of Food Science, University of Guelph, Guelph, Ontario, Canada, N1G 2W1.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Buraczynski', 'Affiliation': 'Department of Food Science, University of Guelph, Guelph, Ontario, Canada, N1G 2W1.'}, {'ForeName': 'Preethi', 'Initials': 'P', 'LastName': 'Jayanth', 'Affiliation': 'Department of Food Science, University of Guelph, Guelph, Ontario, Canada, N1G 2W1.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Rea', 'Affiliation': 'Department of Molecular and Cellular Biology, University of Guelph, Guelph, Ontario, Canada, N1G 2W1.'}, {'ForeName': 'Tariq A', 'Initials': 'TA', 'LastName': 'Akhtar', 'Affiliation': 'Department of Molecular and Cellular Biology, University of Guelph, Guelph, Ontario, Canada, N1G 2W1.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Spagnuolo', 'Affiliation': 'Department of Food Science, University of Guelph, Guelph, Ontario, Canada, N1G 2W1.'}]",Molecular nutrition & food research,['10.1002/mnfr.201900688']
640,31831051,"The effect and mechanism of YH0618 granule on chemotherapy- induced hair loss in patients with breast cancer: study protocol for a randomized, double-blind, multi-center clinical trial.","BACKGROUND


Hair loss is one of the most common side effects of chemotherapy, and can cause persistent negative emotions, further affecting therapeutic effects and reducing the quality of life. However, there are no clinically safe and effective methods to solve the problem at present. Our previous clinical and animal studies showed that a medicinal and edible decoction, YH0618, could significantly promote hair growth in cancer patients after chemotherapy, without interfering with the anti-tumor effects of chemotherapy. Besides, the theory of Chinese Medicine believes that the ""Essence of the kidney is reflected on the hair"". Therefore, this study will further explore the efficacy of YH0618 granule on chemotherapy-induced hair loss in patients with breast cancer by a randomized, double-blind, multi-center clinical trial and elucidate the potential mechanism from the aspect of kidney deficiency or renal dysfunction.
METHODS/DESIGN


Eligible breast cancer patients who will start chemotherapy will be randomly divided into group A (YH0618 granule) and group B (placebo). The chemotherapeutic agents contain taxanes or/and anthracyclines, and the chemotherapy regimen will be for at least six cycles with a cycle every 3 weeks. Subjects assigned to group A will receive YH0618 granules twice a day (6 g each time), 6 days a week, mixed with 300 ml warm water from the first to the fourth chemotherapy cycle. Subjects in group B will receive the placebo granule in the same manner. The primary outcome is the time point of occurrence of hair loss reaching grade II as assessed by the WHO Toxicity Grading Scale, and objective indices of hair quality and hair-follicle growth recorded by a hair and scalp detector before the fifth chemotherapy cycle. Secondary outcomes include changes of facial color and thumbnail color, grading of thumbnails ridging, assessment of quality life, level of fatigue, routine blood test results, hepatic and renal function, and certain medical indicators which can reflect kidney deficiency in Chinese Medicine.
DISCUSSION


This research is of great significance for the treatment of cancer and improving the quality of life of cancer patients. The study may provide the most direct evidence for meeting clinical needs and lay a solid scientific foundation for later product development.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ID: ChiCTR1800020107. Registered on 14 December 2018.",2019,"The primary outcome is the time point of occurrence of hair loss reaching grade II as assessed by the WHO Toxicity Grading Scale, and objective indices of hair quality and hair-follicle growth recorded by a hair and scalp detector before the fifth chemotherapy cycle.","['patients with breast cancer', 'Eligible breast cancer patients who will start chemotherapy', 'cancer patients']","['placebo', 'group B (placebo']","['time point of occurrence of hair loss reaching grade II as assessed by the WHO Toxicity Grading Scale, and objective indices of hair quality and hair-follicle growth recorded by a hair and scalp detector', 'quality of life', 'hair growth', 'changes of facial color and thumbnail color, grading of thumbnails ridging, assessment of quality life, level of fatigue, routine blood test results, hepatic and renal function, and certain medical indicators which can reflect kidney deficiency in Chinese Medicine']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0222045'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0221971', 'cui_str': 'Hair Follicle'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C0034380'}, {'cui': 'C0232407', 'cui_str': 'Hair growth, function (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0222002', 'cui_str': 'Structure of nail of thumb'}, {'cui': 'C0332243', 'cui_str': 'Ridging (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C2586108', 'cui_str': 'Level of fatigue (observable entity)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0018941', 'cui_str': 'Blood Tests'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0205423', 'cui_str': 'Certainty (attribute)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]",,0.217556,"The primary outcome is the time point of occurrence of hair loss reaching grade II as assessed by the WHO Toxicity Grading Scale, and objective indices of hair quality and hair-follicle growth recorded by a hair and scalp detector before the fifth chemotherapy cycle.","[{'ForeName': 'Jie-Shu', 'Initials': 'JS', 'LastName': 'You', 'Affiliation': 'School of Basic Medical Sciences, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Galactophore Department, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Galactophore Department, The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Xin-Lei', 'Initials': 'XL', 'LastName': 'Shi', 'Affiliation': 'Galactophore Department, The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Man-di', 'Initials': 'MD', 'LastName': 'Lin', 'Affiliation': 'Galactophore Department, The First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Guo', 'Affiliation': 'Galactophore Department, The Third Hospital of Nanchang, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Ya-Li', 'Initials': 'YL', 'LastName': 'Cao', 'Affiliation': 'Galactophore Department, The Third Hospital of Nanchang, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'You-Zhi', 'Initials': 'YZ', 'LastName': 'Sun', 'Affiliation': 'Basic Medical College, Jiangxi University of Chinese Medicine, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': 'School of Basic Medical Sciences, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Wei-Ling', 'Initials': 'WL', 'LastName': 'Qu', 'Affiliation': 'School of Basic Medical Sciences, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Huan-Lan', 'Initials': 'HL', 'LastName': 'Liu', 'Affiliation': 'School of Basic Medical Sciences, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Jian-Ping', 'Initials': 'JP', 'LastName': 'Chen', 'Affiliation': 'School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong. abchen@hku.hk.'}]",Trials,['10.1186/s13063-019-3893-3']
641,31853899,Somatosensory changes in Chinese patients after coronectomy vs. total extraction of mandibular third molar: a prospective study.,"OBJECTIVES


This study aimed to quantitatively compare the somatosensory function changes of inferior alveolar nerve (IAN) after mandibular third molar extraction with a surgery protocol of coronectomy, as opposed to the conventional method.
MATERIALS AND METHODS


Patients with a lower third molar directly contacting IAN were recruited and assigned either to a test group (coronectomy group) or a control group (conventional extraction). A standardized quantitative sensory testing (QST) battery was performed for four times: one week before surgery and the second, seventh, and 28th days after surgery. Z-scores and the loss/gain coding system were applied for each participant.
RESULTS


A total of 140 molars (test group: n = 91, control group: n = 49) were enrolled. The sensitivity of the mechanical detection threshold (MDT) and pressure pain threshold (PPT) significantly increased after surgery more than before surgery in both groups (P ≤ 0.001). After the surgery, the sensitivities of the cold detection threshold (CDT), cold pain threshold (CPT), and heat pain threshold (HPT) were significantly higher in the test group than in the control group (P ≤ 0.027). The risk of IANI was significantly larger (P = 0.041) in the test group than in the control group.
CONCLUSIONS


QST was a sensitive way to detect somatosensory abnormalities even with no subjective complaint caused by surgery. Coronectomy had less influence on IAN function than conventional total extraction.
CLINICAL RELEVANCE


The somatosensory function changes after mandibular third molar extraction were quantitatively studied, and coronectomy was proved a reliable alternation to reduce IAN injury rate.",2020,The sensitivity of the mechanical detection threshold (MDT) and pressure pain threshold (PPT) significantly increased after surgery more than before surgery in both groups (P ≤ 0.001).,"['Patients with a lower third molar directly contacting IAN', 'A total of 140 molars (test group: n\u2009=\u200991, control group: n\u2009=\u200949) were enrolled', 'Chinese patients after coronectomy vs. total extraction of mandibular third molar']","['QST', 'test group (coronectomy group) or a control group (conventional extraction']","['sensitivity of the mechanical detection threshold (MDT) and pressure pain threshold (PPT', 'IAN function', 'risk of IANI', 'Z-scores and the loss/gain coding system', 'sensitivities of the cold detection threshold (CDT), cold pain threshold (CPT), and heat pain threshold (HPT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]","[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0018837', 'cui_str': 'Heat'}]",140.0,0.0422519,The sensitivity of the mechanical detection threshold (MDT) and pressure pain threshold (PPT) significantly increased after surgery more than before surgery in both groups (P ≤ 0.001).,"[{'ForeName': 'Zi-Yu', 'Initials': 'ZY', 'LastName': 'Yan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, 22 South Street Zhong Guan Cun, Haidian District, Beijing, 100081, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Yan', 'Affiliation': 'Department of Medical Statistics, Peking University Clinical Research Institute, Beijing, China.'}, {'ForeName': 'Chuan-Bin', 'Initials': 'CB', 'LastName': 'Guo', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology, 22 South Street Zhong Guan Cun, Haidian District, Beijing, 100081, China.'}, {'ForeName': 'Qiu-Fei', 'Initials': 'QF', 'LastName': 'Xie', 'Affiliation': 'Department of Prosthodontics and Center for Oral Functional Diagnosis, Treatment and Research, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Guang-Ju', 'Initials': 'GJ', 'LastName': 'Yang', 'Affiliation': 'Department of Prosthodontics and Center for Oral Functional Diagnosis, Treatment and Research, Peking University School and Hospital of Stomatology, Beijing, China.'}, {'ForeName': 'Nian-Hui', 'Initials': 'NH', 'LastName': 'Cui', 'Affiliation': 'Department of Oral and Maxillofacial Surgery Peking University School and Hospital of Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Laboratory for Digital and Material Technology of Stomatology & Beijing Key Laboratory of Digital Stomatology, Beijing, 100081, China. drcuinianhui@163.com.'}]",Clinical oral investigations,['10.1007/s00784-019-03169-4']
642,31847912,Effectiveness and cost-effectiveness of Improving clinicians' diagnostic and communication Skills on Antibiotic prescribing Appropriateness in patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study): study protocol for a cluster randomised controlled trial.,"BACKGROUND


Despite their marginal benefit, about 60% of acute lower respiratory tract infections (ALRTIs) are currently treated with antibiotics in Catalonia. This study aims to evaluate the effectiveness and efficiency of a continuous disease-focused intervention (C-reactive protein [CRP]) and an illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations) on antibiotic prescribing in patients with ALRTIs in Catalan primary care centres.
METHODS/DESIGN


A cluster randomised, factorial, controlled trial aimed at including 20 primary care centres (N = 2940 patients) with patients older than 18 years of age presenting for a first consultation with an ALRTI will be included in the study. Primary care centres will be identified on the basis of socioeconomic data and antibiotic consumption. Centres will be randomly assigned according to hierarchical clustering to any of four trial arms: usual care, CRP testing, enhanced communication skills backed up with patient leaflets, or combined interventions. A cost-effectiveness and cost-utility analysis will be performed from the societal and national healthcare system perspectives, and the time horizon of the analysis will be 1 year. Two qualitative studies (pre- and post-clinical trial) aimed to identify the expectations and concerns of patients with ALRTIs and the barriers and facilitators of each intervention arm will be run. Family doctors and nurses assigned to the interventions will participate in a 2-h training workshop before the inception of the trial and will receive a monthly intervention-tailored training module during the year of the trial period. Primary outcomes will be antibiotic use within the first 6 weeks, duration of moderate to severe cough, and the quality-adjusted life-years. Secondary outcomes will be duration of illness and severity of cough measured using a symptom diary, healthcare re-consultations, hospital admissions, and complications. Healthcare costs will be considered and expressed in 2021 euros (year foreseen to finalise the study) of the current year of the analysis. Univariate and multivariate sensitivity analyses will be carried out.
DISCUSSION


The ISAAC-CAT project will contribute to evaluate the effectiveness and efficiency of different strategies for more appropriate antibiotic prescribing that are currently out of the scope of the actual clinical guidelines.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03931577.",2019,"Centres will be randomly assigned according to hierarchical clustering to any of four trial arms: usual care, CRP testing, enhanced communication skills backed up with patient leaflets, or combined interventions.","['patients with acute Cough in primary care in CATalonia (the ISAAC-CAT study', 'patients with ALRTIs in Catalan primary care centres', '20 primary care centres (N\xa0=\u20092940 patients) with patients older than 18\u2009years of age presenting for a first consultation with an ALRTI will be included in the study']","['continuous disease-focused intervention (C-reactive protein [CRP]) and an illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations', 'usual care, CRP testing, enhanced communication skills backed up with patient leaflets, or combined interventions', ""clinicians' diagnostic and communication Skills""]","['Effectiveness and cost-effectiveness', 'antibiotic use within the first 6\u2009weeks, duration of moderate to severe cough, and the quality-adjusted life-years', 'effectiveness and efficiency', 'duration of illness and severity of cough measured using a symptom diary, healthcare re-consultations, hospital admissions, and complications', 'Healthcare costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0742857', 'cui_str': 'Acute cough'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C1995000', 'cui_str': 'Back structure, excluding neck'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}]",2940.0,0.14193,"Centres will be randomly assigned according to hierarchical clustering to any of four trial arms: usual care, CRP testing, enhanced communication skills backed up with patient leaflets, or combined interventions.","[{'ForeName': 'Rafa', 'Initials': 'R', 'LastName': 'Ruiz', 'Affiliation': 'Institut Català de la Salut, Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Moragas', 'Affiliation': ""Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Trapero-Bertran', 'Affiliation': 'Research Institute for Evaluation and Public Policies (IRAPP), Universitat Internacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Sisó', 'Affiliation': 'Fundació Atenció Primària, Barcelona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Berenguera', 'Affiliation': ""Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès, Spain.""}, {'ForeName': 'Glòria', 'Initials': 'G', 'LastName': 'Oliva', 'Affiliation': 'Ministry of Health, Government of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Alícia', 'Initials': 'A', 'LastName': 'Borràs-Santos', 'Affiliation': ""Institut Universitari de Pacients (Patients' University Institut), Universitat Internacional de Catalunya, Barcelona, Spain.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'García-Sangenís', 'Affiliation': ""Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.""}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Puig-Junoy', 'Affiliation': 'Pompeu Fabra University (UPF)-Barcelona School of Management, Barcelona, Spain of Economics and Business, Barcelona, Spain.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Cots', 'Affiliation': 'Universitat de Barcelona, La Marina Health Centre, Institut Català de la Salut, Barcelona, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Morros', 'Affiliation': ""Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès, Spain.""}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Mora', 'Affiliation': 'Research Institute for Evaluation and Public Policies (IRAPP), Universitat Internacional de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lanau-Roig', 'Affiliation': ""La Marina Health Centre, Institut Català de la Salut, Associació d'Infermeria Familiar i Comunitària de Catalunya, Barcelona, Spain.""}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Monfà', 'Affiliation': ""Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), UICEC de IDIAP Jordi Gol - Plataforma SCReN, Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès, Spain.""}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Troncoso', 'Affiliation': 'Àrea de Suport al Medicament i Servei de Farmàcia Barcelona, Institut Català de la Salut, Barcelona, Spain.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Abellana', 'Affiliation': 'Biostatistics, Department of Basic Clinical Practice, Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Gálvez', 'Affiliation': ""Institut Universitari de Pacients (Patients' University Institut), Universitat Internacional de Catalunya, Barcelona, Spain.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Medina-Perucha', 'Affiliation': ""Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès, Spain.""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bjerrum', 'Affiliation': 'Centre for General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Amo', 'Affiliation': ""Institut Universitari de Pacients (Patients' University Institut), Universitat Internacional de Catalunya, Barcelona, Spain.""}, {'ForeName': 'Nieves', 'Initials': 'N', 'LastName': 'Barragán', 'Affiliation': 'Catalan Society of Family Medicine, Group on Communication, Health Centre Vallcarca, Barcelona, Spain.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Llor', 'Affiliation': ""Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Manso Health Centre, Institut Català de la Salut, Barcelona, Spain. carles.llor@gmail.com.""}]",Trials,['10.1186/s13063-019-3727-3']
643,32084522,Phase I Trial of MRI-Guided Prostate Cancer Lattice Extreme Ablative Dose (LEAD) Boost Radiation Therapy.,"PURPOSE


A phase I clinical trial was designed to test the feasibility and toxicity of administering high-dose spatially fractionated radiation therapy to magnetic resonance imaging (MRI)-defined prostate tumor volumes, in addition to standard treatment.
METHODS AND MATERIALS


We enrolled 25 men with favorable to high-risk prostate cancer and 1 to 3 suspicious multiparametric MRI (mpMRI) gross tumor volumes (GTVs). The mpMRI-GTVs were treated on day 1 with 12 to 14 Gy via dose cylinders using a lattice extreme ablative dose technique. The entire prostate, along with the proximal seminal vesicles, was then treated to 76 Gy at 2 Gy/fraction. For some high-risk patients, the distal seminal vesicles and pelvic lymph nodes received 56 Gy at 1.47 Gy/fraction concurrently in 38 fractions. The total dose to the lattice extreme ablative dose cylinder volume(s) was 88 to 90 Gy (112-123 Gy in 2.0 Gy equivalents, assuming an α-to-β ratio of 3).
RESULTS


Dosimetric parameters were satisfactorily met. Median follow-up was 66 months. There were no grade 3 acute/subacute genitourinary or gastrointestinal adverse events. Maximum late genitourinary toxicity was grade 1 in 15 (60%), grade 2 in 4 (16%), and grade 4 in 1 (4%; sepsis after a posttreatment transurethral resection). Maximum late gastrointestinal toxicity was grade 1 in 11 (44%) and grade 2 in 4 (16%). Two patients experienced biochemical failure.
CONCLUSIONS


External beam radiation therapy delivered with an upfront spatially fractionated, stereotactic high-dose mpMRI-GTV boost is feasible and was not associated with any unexpected events. The technique is now part of a follow-up phase II randomized trial.",2020,"Maximum late GU toxicity was Grade 1 in 15 (60%), Grade 2 in 4 (16%), and Grade 4 in 1 (4%; sepsis after a post-treatment transurethral resection).",['We enrolled 25 men with favorable to high-risk prostate cancer and 1-3 suspicious multiparametric MRI (mpMRI) gross tumor volumes (GTVs'],"['MRI-GUIDED Prostate Cancer Lattice Extreme Ablative Dose (LEAD', 'BOOST Radiotherapy', 'Lattice Extreme Ablative Dose (LEAD) technique', 'PHASE']","['biochemical failure', 'grade 3 acute/subacute genitourinary (GU) or gastrointestinal (GI) adverse events', 'Maximum late GU toxicity', 'feasibility and toxicity', 'Maximum late GI toxicity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0475645', 'cui_str': 'Gross tumor volume (observable entity)'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",25.0,0.038764,"Maximum late GU toxicity was Grade 1 in 15 (60%), Grade 2 in 4 (16%), and Grade 4 in 1 (4%; sepsis after a post-treatment transurethral resection).","[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Pollack', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida. Electronic address: apollack@med.miami.edu.'}, {'ForeName': 'Felix M', 'Initials': 'FM', 'LastName': 'Chinea', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bossart', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Deukwoo', 'Initials': 'D', 'LastName': 'Kwon', 'Affiliation': 'Departments of Public Health Sciences and Biostatistics and Bioinformatics Shared Resource, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Abramowitz', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lynne', 'Affiliation': 'Departments of Urology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Merce', 'Initials': 'M', 'LastName': 'Jorda', 'Affiliation': 'Departments of Pathology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Marples', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Vivek N', 'Initials': 'VN', 'LastName': 'Patel', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Biophysics Research Institute of America, Miami, Florida.'}, {'ForeName': 'Isildinha', 'Initials': 'I', 'LastName': 'Reis', 'Affiliation': 'Departments of Public Health Sciences and Biostatistics and Bioinformatics Shared Resource, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Studenski', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Casillas', 'Affiliation': 'Department of Radiology, University of Miami, Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Radka', 'Initials': 'R', 'LastName': 'Stoyanova', 'Affiliation': 'Departments of Radiation Oncology, University of Miami Miller School of Medicine, Miami, Florida.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.01.052']
644,31043346,The Pathways for African American Success: Does Delivery Platform Matter in the Prevention of HIV Risk Vulnerability Among Youth?,"PURPOSE


Technology provides new possibilities for disseminating effective prevention programming to underserved families, such as those residing in rural communities. The present study is an evaluation of a technology-delivered HIV risk prevention program designed for rural African-American families, Pathways for African American Success (PAAS), to determine its promise for increasing access to evidence-based youth risk prevention programs among those in the greatest need.
METHODS


Four hundred and twelve parent/youth dyads were randomly assigned to one of three conditions: (1) in-person facilitator-led PAAS small group, (2) self-directed PAAS technology, or (3) a literature control with home-mailed educational materials.
RESULTS


Compared with families in the literature control condition, families assigned to the PAAS technology or small group conditions demonstrated significantly stronger intervention induced parent-child protective processes (e.g., enhanced discussion quality, clearly articulated norms, and parental expectations about risk engagement) and lower youth intentions to engage in risky behaviors 6 months postintervention. Although some important nuances were noted, this study suggests that the PAAS technology-delivered modality is just as efficacious as the in-person facilitator-led, small group modality in dissuading HIV-related risk behaviors among rural African-American youths.
CONCLUSIONS


Implications for having a menu of service delivery models that address the diverse needs and contexts of families are discussed, including the promise of technology as an alternative modality for reaching populations often characterized as difficult to reach and to engage in family-based preventive interventions.",2019,"Compared with families in the literature control condition, families assigned to the PAAS technology or small group conditions demonstrated significantly stronger intervention induced parent-child protective processes (e.g., enhanced discussion quality, clearly articulated norms, and parental expectations about risk engagement) and lower youth intentions to engage in risky behaviors 6 months postintervention.","['rural African-American families', 'Four hundred and twelve parent/youth dyads', 'African American Success', 'rural African-American youths']","['person facilitator-led PAAS small group, (2) self-directed PAAS technology, or (3)\xa0a literature control with home-mailed educational materials', 'technology-delivered HIV risk prevention program']","['stronger intervention induced parent-child protective processes (e.g., enhanced discussion quality, clearly articulated norms, and parental expectations about risk engagement) and lower youth intentions to engage in risky behaviors']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0267964', 'cui_str': 'Pancreatic acinar atrophy (disorder)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0274842,"Compared with families in the literature control condition, families assigned to the PAAS technology or small group conditions demonstrated significantly stronger intervention induced parent-child protective processes (e.g., enhanced discussion quality, clearly articulated norms, and parental expectations about risk engagement) and lower youth intentions to engage in risky behaviors 6 months postintervention.","[{'ForeName': 'Velma McBride', 'Initials': 'VM', 'LastName': 'Murry', 'Affiliation': 'Department of Human and Organizational Development, Peabody College, Vanderbilt University, Nashville, Tennessee. Electronic address: velma.m.murry@vanderbilt.edu.'}, {'ForeName': 'Heather Hensman', 'Initials': 'HH', 'LastName': 'Kettrey', 'Affiliation': 'Department of Sociology, Anthropology & Criminal Justice, Clemson University, Clemson, South Carolina.'}, {'ForeName': 'Cady', 'Initials': 'C', 'LastName': 'Berkel', 'Affiliation': 'REACH Institute (formerly the Prevention Research Center), Arizona State University, Tempe, Arizona.'}, {'ForeName': 'Misha N', 'Initials': 'MN', 'LastName': 'Inniss-Thompson', 'Affiliation': 'Department of Human and Organizational Development, Peabody College, Vanderbilt University, Nashville, Tennessee.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2019.02.013']
645,31328540,The effect of a stability and coordination training programme on balance in older adults with cardiovascular disease: a randomised exploratory study.,"BACKGROUND


Cardiovascular diseases are considered a leading factor in mortality and morbidity. The older adult population with cardiovascular diseases has a higher risk of falls as compared to a matched age healthy population.
OBJECTIVE


To investigate the effect of stability and coordination training within a cardiac rehabilitation programme on fall risk in older adults with cardiovascular diseases enrolled in cardiac rehabilitation.
METHODS


Twenty-six people with cardiovascular diseases (age 74±8) were divided randomly into intervention and control groups. The intervention group received 20 min of stability and coordination exercises as part of their 80 min cardiac rehabilitation programme, while the control group performed the traditional cardiac rehabilitation programme, twice a week, for 12 weeks. Balance assessment was based on three tests: the Timed Up and Go, Functional Reach and Balance Error Scoring System, which were measured twice before the intervention, once following the intervention and once four weeks after the termination of the intervention. A two-way analysis of variance (group × time) with repeated measures was performed to examine differences between groups and between assessments.
RESULTS


Seventy per cent of participants in the intervention group adhered to the programme, with significant improvement post-intervention in the Timed Up and Go ( p  < .01) and the Balance Error Scoring System ( p  < .05) with no changes among the control group.
DISCUSSION


Stability and coordination training alongside a traditional cardiac rehabilitation programme may improve static and dynamic balance, and muscle strength, skills that are considered major components in postural control. Clinicians who work in cardiac rehabilitation centres should consider including this training alongside the routine cardiac rehabilitation programme.",2019,"RESULTS


Seventy per cent of participants in the intervention group adhered to the programme, with significant improvement post-intervention in the Timed Up and Go ( p  < .01) and the Balance Error Scoring System ( p  < .05) with no changes among the control group.
","['Twenty-six people with cardiovascular diseases (age 74±8', 'older adults with cardiovascular disease', 'older adult population with cardiovascular diseases', 'older adults with cardiovascular diseases enrolled in cardiac rehabilitation']","['stability and coordination training programme', 'cardiac rehabilitation programme', 'stability and coordination training', '20 min of stability and coordination exercises as part of their 80 min cardiac rehabilitation programme, while the control group performed the traditional cardiac rehabilitation programme']","['Timed Up and Go, Functional Reach and Balance Error', 'Balance Error Scoring System']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0419112', 'cui_str': 'Coordination training'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0203990', 'cui_str': 'Coordination exercise (regime/therapy)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C1321055', 'cui_str': 'Functional reach'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]",26.0,0.0217928,"RESULTS


Seventy per cent of participants in the intervention group adhered to the programme, with significant improvement post-intervention in the Timed Up and Go ( p  < .01) and the Balance Error Scoring System ( p  < .05) with no changes among the control group.
","[{'ForeName': 'Daria', 'Initials': 'D', 'LastName': 'Segev', 'Affiliation': 'Department of Life Sciences, The Academic College at Wingate, Wingate Institute, Israel.'}, {'ForeName': 'Devora', 'Initials': 'D', 'LastName': 'Hellerstein', 'Affiliation': 'Department of Life Sciences, The Academic College at Wingate, Wingate Institute, Israel.'}, {'ForeName': 'Rafi', 'Initials': 'R', 'LastName': 'Carasso', 'Affiliation': 'Neurology Department, The Hillel Yaffe Medical Centre, Israel.'}, {'ForeName': 'Ayelet', 'Initials': 'A', 'LastName': 'Dunsky', 'Affiliation': 'Department of Life Sciences, The Academic College at Wingate, Wingate Institute, Israel.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515119864201']
646,31287522,Effect of Peroral Endoscopic Myotomy vs Pneumatic Dilation on Symptom Severity and Treatment Outcomes Among Treatment-Naive Patients With Achalasia: A Randomized Clinical Trial.,"Importance


Case series suggest favorable results of peroral endoscopic myotomy (POEM) for treatment of patients with achalasia. Data comparing POEM with pneumatic dilation, the standard treatment for patients with achalasia, are lacking.
Objective


To compare the effects of POEM vs pneumatic dilation as initial treatment of treatment-naive patients with achalasia.
Design, Setting, and Participants


This randomized multicenter clinical trial was conducted at 6 hospitals in the Netherlands, Germany, Italy, Hong Kong, and the United States. Adult patients with newly diagnosed achalasia and an Eckardt score greater than 3 who had not undergone previous treatment were included. The study was conducted between September 2012 and July 2015, the duration of follow-up was 2 years after the initial treatment, and the final date of follow-up was November 22, 2017.
Interventions


Randomization to receive POEM (n = 67) or pneumatic dilation with a 30-mm and a 35-mm balloon (n = 66), with stratification according to hospital.
Main Outcomes and Measures


The primary outcome was treatment success (defined as an Eckardt score ≤3 and the absence of severe complications or re-treatment) at the 2-year follow-up. A total of 14 secondary end points were examined among patients without treatment failure, including integrated relaxation pressure of the lower esophageal sphincter via high-resolution manometry, barium column height on timed barium esophagogram, and presence of reflux esophagitis.
Results


Of the 133 randomized patients, 130 (mean age, 48.6 years; 73 [56%] men) underwent treatment (64 in the POEM group and 66 in the pneumatic dilation group) and 126 (95%) completed the study. The primary outcome of treatment success occurred in 58 of 63 patients (92%) in the POEM group vs 34 of 63 (54%) in the pneumatic dilation group, a difference of 38% ([95% CI, 22%-52%]; P < .001). Of the 14 prespecified secondary end points, no significant difference between groups was demonstrated in 10 end points. There was no significant between-group difference in median integrated relaxation pressure (9.9 mm Hg in the POEM group vs 12.6 mm Hg in the pneumatic dilation group; difference, 2.7 mm Hg [95% CI, -2.1 to 7.5]; P = .07) or median barium column height (2.3 cm in the POEM group vs 0 cm in the pneumatic dilation group; difference, 2.3 cm [95% CI, 1.0-3.6]; P = .05). Reflux esophagitis occurred more often in the POEM group than in the pneumatic dilation group (22 of 54 [41%] vs 2 of 29 [7%]; difference, 34% [95% CI, 12%-49%]; P = .002). Two serious adverse events, including 1 perforation, occurred after pneumatic dilation, while no serious adverse events occurred after POEM.
Conclusions and Relevance


Among treatment-naive patients with achalasia, treatment with POEM compared with pneumatic dilation resulted in a significantly higher treatment success rate at 2 years. These findings support consideration of POEM as an initial treatment option for patients with achalasia.
Trial Registration


Netherlands Trial Register number: NTR3593.",2019,"There was no significant between-group difference in median integrated relaxation pressure (9.9 mm Hg in the POEM group vs 12.6 mm Hg in the pneumatic dilation group; difference, 2.7 mm Hg [95% CI, -2.1 to 7.5]; P = .07) or median barium column height (2.3 cm in the POEM group vs 0 cm in the pneumatic dilation group; difference, 2.3 cm [95% CI, 1.0-3.6]; P = .05).","['6 hospitals in the Netherlands, Germany, Italy, Hong Kong, and the United States', 'patients with achalasia', 'treatment-naive patients with achalasia', 'Treatment-Naive Patients With Achalasia', 'patients with achalasia, are lacking', 'Adult patients with newly diagnosed achalasia and an Eckardt score greater than 3 who had not undergone previous treatment were included', '133 randomized patients, 130 (mean age, 48.6 years', '73 [56%] men) underwent treatment (64 in the POEM group and 66 in the pneumatic dilation group) and 126 (95%) completed the study', 'September 2012 and July 2015, the duration of follow-up was 2 years after the initial treatment, and the final date of follow-up was November 22, 2017']","['POEM vs pneumatic dilation', 'POEM', 'POEM with pneumatic dilation', 'POEM (n\u2009=\u200967) or pneumatic dilation with a 30-mm and a 35-mm balloon', 'peroral endoscopic myotomy (POEM', 'pneumatic dilation', 'Peroral Endoscopic Myotomy vs Pneumatic Dilation']","['median integrated relaxation pressure', 'integrated relaxation pressure of the lower esophageal sphincter via high-resolution manometry, barium column height on timed barium esophagogram, and presence of reflux esophagitis', 'Symptom Severity and Treatment Outcomes', 'serious adverse events', 'median barium column height', 'treatment success (defined as an Eckardt score ≤3 and the absence of severe complications or re-treatment', 'treatment success', 'Reflux esophagitis']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1321756', 'cui_str': 'Achalasia (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}]","[{'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0450396', 'cui_str': '30mm (qualifier value)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0185181', 'cui_str': 'Myotomy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0014865', 'cui_str': 'Esophageal sphincter (body structure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C0004749', 'cui_str': 'Barium'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0677659', 'cui_str': 'Gastroesophageal reflux disease with esophagitis (disorder)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0085415'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",133.0,0.151226,"There was no significant between-group difference in median integrated relaxation pressure (9.9 mm Hg in the POEM group vs 12.6 mm Hg in the pneumatic dilation group; difference, 2.7 mm Hg [95% CI, -2.1 to 7.5]; P = .07) or median barium column height (2.3 cm in the POEM group vs 0 cm in the pneumatic dilation group; difference, 2.3 cm [95% CI, 1.0-3.6]; P = .05).","[{'ForeName': 'Fraukje A', 'Initials': 'FA', 'LastName': 'Ponds', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fockens', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Aaltje', 'Initials': 'A', 'LastName': 'Lei', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Neuhaus', 'Affiliation': 'Department of Gastroenterology, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Beyna', 'Affiliation': 'Department of Gastroenterology, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Jennis', 'Initials': 'J', 'LastName': 'Kandler', 'Affiliation': 'Department of Gastroenterology, Evangelisches Krankenhaus Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Frieling', 'Affiliation': 'Department of Gastroenterology, Helios Klinikum Krefeld, Düsseldorf, Germany.'}, {'ForeName': 'Philip W Y', 'Initials': 'PWY', 'LastName': 'Chiu', 'Affiliation': 'Institute of Digestive Disease, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Justin C Y', 'Initials': 'JCY', 'LastName': 'Wu', 'Affiliation': 'Institute of Digestive Disease, Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hongkong, China.'}, {'ForeName': 'Vivien W Y', 'Initials': 'VWY', 'LastName': 'Wong', 'Affiliation': 'Institute of Digestive Disease, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Costamagna', 'Affiliation': 'Digestive Endoscopy Unit, Agostino Gemelli University Hospital, Universita Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Familiari', 'Affiliation': 'Digestive Endoscopy Unit, Agostino Gemelli University Hospital, Universita Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kahrilas', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Pandolfino', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'André J P M', 'Initials': 'AJPM', 'LastName': 'Smout', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Bredenoord', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}]",JAMA,['10.1001/jama.2019.8859']
647,31324495,The impact of tooth brushing versus tooth brushing and chlorhexidine application to avoid postoperative pneumonia in children.,"BACKGROUND


The pathogenesis of postsurgical pneumonia is a complicated and multifactorial process, in which elements like oral bacteria, orotracheal intubation, and dental hygiene play an important role. The objective of this study was to evaluate the efficacy of 2 types of oral hygiene interventions in decreasing cases of postsurgical pneumonia.
METHODS


In pediatric patients scheduled for surgery, a quasi-experimental study was carried out over a 2-year period to evaluate the efficacy of 2 types of oral hygiene interventions. There were 2 groups of intervention with 1 group for comparison. Intervention groups were tooth brushing by a dentist (intervention group 1) and dental brushing by parents + chlorhexidine gluconate (intervention group 2). Data from the year with no oral hygiene interventions were used as the baseline group.
RESULTS


A total of 2,535 surgical procedures were followed. Baseline group incidence of postoperative pneumonia was 10 per 1,000 surgeries, 0.2 per 1,000 surgeries in the intervention group 1 (P = .04), and 0.8 per 1,000 surgeries in the intervention group 2. Intervention group 1 was protective against postoperative pneumonia (odds ratio, 0.06; P = .02; 95% confidence interval, 0.033-0.079), but there was no benefit with intervention group 2 (odds ratio, 0.87; P = .599; 95% confidence interval, 0.52-1.46).
CONCLUSIONS


Dental brushing performed before surgery by a pediatric dentist was effective in reducing the incidence of postoperative pneumonia in pediatric patients.",2019,"Intervention group 1 was protective against postoperative pneumonia (odds ratio, 0.06; P = .02; 95% confidence interval, 0.033-0.079), but there was no benefit with intervention group 2 (odds ratio, 0.87; P = .599; 95% confidence interval, 0.52-1.46).
","['children', 'pediatric patients scheduled for surgery, a quasi-experimental study', 'pediatric patients']","['chlorhexidine application', 'tooth brushing by a dentist (intervention group 1) and dental brushing by parents\u202f+\u202fchlorhexidine gluconate', 'oral hygiene interventions']","['protective against postoperative pneumonia', 'postoperative pneumonia']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2985410', 'cui_str': 'Clinical Trials, Nonrandomized'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0011441', 'cui_str': 'Dentist'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}, {'cui': 'C1272386', 'cui_str': 'Mouth care management'}]","[{'cui': 'C1279386', 'cui_str': 'Postoperative pneumonia'}]",2535.0,0.0743933,"Intervention group 1 was protective against postoperative pneumonia (odds ratio, 0.06; P = .02; 95% confidence interval, 0.033-0.079), but there was no benefit with intervention group 2 (odds ratio, 0.87; P = .599; 95% confidence interval, 0.52-1.46).
","[{'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'González-Rubio Aguilar', 'Affiliation': 'Department of Stomatology, Pediatric Odontology Service, Hospital Infantil de México Federico Gómez, México City, Mexico. Electronic address: prizy73@hotmail.com.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Ávalos Arenas', 'Affiliation': 'Department of Stomatology, Pediatric Odontology Service, Hospital Infantil de México Federico Gómez, México City, Mexico.'}, {'ForeName': 'Nancy Anahí', 'Initials': 'NA', 'LastName': 'Vega Gudiño', 'Affiliation': 'Department of Stomatology, Pediatric Odontology Service, Hospital Infantil de México Federico Gómez, México City, Mexico.'}, {'ForeName': 'Samantha Daniela', 'Initials': 'SD', 'LastName': 'Moreno Herrera', 'Affiliation': 'Hospital Infantil de México Federico Gómez, México City, Mexico.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Villa Guillén', 'Affiliation': 'Hospital Infantil de México Federico Gómez, México City, Mexico.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Moyao-García', 'Affiliation': 'Hospital Infantil de México Federico Gómez, México City, Mexico.'}, {'ForeName': 'Rodolfo', 'Initials': 'R', 'LastName': 'Fragoso Ríos', 'Affiliation': 'Hospital Infantil de México Federico Gómez, México City, Mexico.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Cuairán Ruidíaz', 'Affiliation': 'Hospital Infantil de México Federico Gómez, México City, Mexico.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Castro Díaz', 'Affiliation': 'Hospital Infantil de México Federico Gómez, México City, Mexico.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'De la Rosa Zamboni', 'Affiliation': 'Hospital Infantil de México Federico Gómez, México City, Mexico.'}]",American journal of infection control,['10.1016/j.ajic.2019.05.018']
648,32161366,Oxytocin induces long-lasting adaptations within amygdala circuitry in autism: a treatment-mechanism study with randomized placebo-controlled design.,"Intranasal administration of the neuropeptide oxytocin (IN-OT) is increasingly explored as a potential treatment for targeting the core symptoms of autism spectrum disorder (ASD). To date, however, the impact of multiple-dose IN-OT treatment on human neural circuitry is largely unknown, and also the possibility that long-term IN-OT use may induce long-lasting neural adaptations remains unexplored. Using a double-blind, randomized, placebo-controlled, between-subject design (including 38 adult men with ASD), this treatment-mechanism study showed that 4 weeks of daily oxytocin administration (24 IU/day) significantly altered intrinsic (resting-state fMRI) functional connectivity of the amygdala to core regions of the ""social brain"" (particularly orbitofrontal cortex and superior temporal sulcus) up to 4 weeks and 1 year post treatment. The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors. These observations contribute to a deeper mechanistic understanding of the neural substrates that underlie behavioral effects of multiple-dose IN-OT treatment, and provide initial insights into the long-lasting neural consequences of chronic IN-OT use on amygdala circuitry. Future studies are however warranted to further elucidate the long-term impact of IN-OT treatment on human neural circuitry and its behavioral consequences.",2020,The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors.,"['38 adult men with ASD', 'autism']","['neuropeptide oxytocin (IN-OT', 'oxytocin', 'Oxytocin', 'placebo']","['altered intrinsic (resting-state fMRI) functional connectivity of the amygdala to core regions of the ""social brain"" (particularly orbitofrontal cortex and superior temporal sulcus']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0228237', 'cui_str': 'Structure of superior temporal sulcus'}]",38.0,0.130252,The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors.,"[{'ForeName': 'Kaat', 'Initials': 'K', 'LastName': 'Alaerts', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium. Kaat.Alaerts@kuleuven.be.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bernaerts', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Jellina', 'Initials': 'J', 'LastName': 'Prinsen', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Dillen', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Steyaert', 'Affiliation': 'Department of Neurosciences, Group Biomedical Sciences, Psychiatry Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wenderoth', 'Affiliation': 'Department of Health Sciences and Technology, Neural Control of Movement Lab, ETH Zurich, Zurich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0653-8']
649,32125197,"Respiratory outcomes after a 1-year treatment of obstructive sleep apnoea with bibloc versus monobloc oral appliances: a multicentre, randomized equivalence trial.","Objective:  The benefit of bibloc over monobloc appliances in treating obstructive sleep apnoea (OSA) has not been evaluated in randomized trials. We hypothesized that these types of appliances would be equally effective. Material and methods:  In this multicentre, randomized equivalence trial, patients with OSA received one type of bibloc or one type of monobloc treatment. At baseline, a 1-night polygraphy study was done, and this was repeated after 1 year. The outcome was any change in the apnoea-hypopnoea index (AHI) and the limits of equivalence between the two devices were set at ±5 AHI units. Results:  Of 302 patients, 146 were randomly assigned to bibloc and 156 to monobloc appliances. In 88 and 104 patients, respectively, there were significant reductions in the AHI ( p  < .001) with a mean change of -16.7 (95% CI -19.4 to -14.1) in the bibloc and -11.8 (-14.9 to -8.7) in the monobloc groups. The proportions of responders defined as having an AHI <10 were 68% and 65% for the bibloc and monobloc groups, respectively. Treatment-related adverse events were mild, transient and the dropouts were more frequent in the bibloc group. Conclusions:  Both types of treatments positively and significantly reduced respiratory disturbances, but at the 1-year follow-up, they were not significantly different in treating OSA, with a numerically greater reduction of the AHI value with the bibloc appliance. However, the higher proportion of treatment-related adverse events and higher proportion of dropouts among bibloc users should be balanced against the advantage of a greater reduction in the AHI.",2020,"In 88 and 104 patients, respectively, there were significant reductions in the AHI ( p  < .001) with a mean change of -16.7 (95% CI -19.4 to -14.1) in the bibloc and -11.8 (-14.9 to -8.7) in the monobloc groups.","['patients with OSA received one type of bibloc or one type of monobloc treatment', 'obstructive sleep apnoea (OSA', '302 patients, 146 were randomly assigned to bibloc and 156 to monobloc appliances']","['bibloc versus monobloc oral appliances', 'bibloc over monobloc appliances']","['apnoea-hypopnoea index (AHI) and the limits of equivalence', 'obstructive sleep apnoea', 'respiratory disturbances', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0243112'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0243112'}]","[{'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",302.0,0.112638,"In 88 and 104 patients, respectively, there were significant reductions in the AHI ( p  < .001) with a mean change of -16.7 (95% CI -19.4 to -14.1) in the bibloc and -11.8 (-14.9 to -8.7) in the monobloc groups.","[{'ForeName': 'Åke', 'Initials': 'Å', 'LastName': 'Tegelberg', 'Affiliation': 'Department of Orofacial Pain and Jaw Function, Malmö University, Malmö, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Nohlert', 'Affiliation': 'Centre for Clinical Research, Uppsala University, Västerås, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bornefalk-Hermansson', 'Affiliation': 'Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Fransson', 'Affiliation': 'Postgraduate Dental Education Center and Faculty of Medicine and Health, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Isacsson', 'Affiliation': 'Department of Orofacial Pain and Jaw Function, Västmanland County Hospital, Västerås, Sweden.'}]",Acta odontologica Scandinavica,['10.1080/00016357.2020.1730436']
650,29800212,Effect of Acupuncture vs Sham Acupuncture on Live Births Among Women Undergoing In Vitro Fertilization: A Randomized Clinical Trial.,"Importance


Acupuncture is widely used by women undergoing in vitro fertilization (IVF), although the evidence for efficacy is conflicting.
Objective


To determine the efficacy of acupuncture compared with a sham acupuncture control performed during IVF on live births.
Design, Setting, and Participants


A single-blind, parallel-group randomized clinical trial including 848 women undergoing a fresh IVF cycle was conducted at 16 IVF centers in Australia and New Zealand between June 29, 2011, and October 23, 2015, with 10 months of pregnancy follow-up until August 2016.
Interventions


Women received either acupuncture (n = 424) or a sham acupuncture control (n = 424). The first treatment was administered between days 6 to 8 of follicle stimulation, and 2 treatments were administered prior to and following embryo transfer. The sham control used a noninvasive needle placed away from the true acupuncture points.
Main Outcomes and Measures


The primary outcome was live birth, defined as the delivery of 1 or more living infants at greater than 20 weeks' gestation or birth weight of at least 400 g.
Results


Among 848 randomized women, 24 withdrew consent, 824 were included in the study (mean [SD] age, 35.4 [4.3] years); 371 [45.0%] had undergone more than 2 previous IVF cycles), 607 proceeded to an embryo transfer, and 809 (98.2%) had data available on live birth outcomes. Live births occurred among 74 of 405 women (18.3%) receiving acupuncture compared with 72 of 404 women (17.8%) receiving sham control (risk difference, 0.5% [95% CI, -4.9% to 5.8%]; relative risk, 1.02 [95% CI, 0.76 to 1.38]).
Conclusions and Relevance


Among women undergoing IVF, administration of acupuncture vs sham acupuncture at the time of ovarian stimulation and embryo transfer resulted in no significant difference in live birth rates. These findings do not support the use of acupuncture to improve the rate of live births among women undergoing IVF.
Trial Registration


anzctr.org.au Identifier: ACTRN12611000226909.",2018,"Live births occurred among 74 of 405 women (18.3%) receiving acupuncture compared with 72 of 404 women (17.8%) receiving sham control (risk difference, 0.5% [95% CI, -4.9% to 5.8%]; relative risk, 1.02 [95% CI, 0.76 to 1.38]).
","['Women Undergoing', 'women undergoing IVF, administration of', 'women undergoing IVF', '848 women undergoing a fresh IVF cycle was conducted at 16 IVF centers in Australia and New Zealand between June 29, 2011, and October 23, 2015, with 10 months of pregnancy follow-up until August 2016', 'women undergoing in vitro fertilization (IVF', '848 randomized women, 24 withdrew consent, 824 were included in the study (mean [SD] age, 35.4 [4.3] years); 371 [45.0%] had undergone more than 2 previous IVF cycles), 607 proceeded to an embryo transfer, and 809 (98.2%) had data available on live birth outcomes']","['Acupuncture', 'Acupuncture vs Sham Acupuncture', 'acupuncture vs sham acupuncture', 'acupuncture', 'acupuncture (n\u2009=\u2009424) or a sham acupuncture control']","['Live Births', 'live birth rates', 'rate of live births', ""live birth, defined as the delivery of 1 or more living infants at greater than 20 weeks' gestation or birth weight"", 'Live births']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}]",848.0,0.705145,"Live births occurred among 74 of 405 women (18.3%) receiving acupuncture compared with 72 of 404 women (17.8%) receiving sham control (risk difference, 0.5% [95% CI, -4.9% to 5.8%]; relative risk, 1.02 [95% CI, 0.76 to 1.38]).
","[{'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Smith', 'Affiliation': 'NICM Health Research Institute, Western Sydney University, Penrith, New South Wales, Australia.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'de Lacey', 'Affiliation': 'College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chapman', 'Affiliation': ""School of Women's & Children Health, University of New South Wales, IVF Australia, Sydney, New South Wales, Australia.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ratcliffe', 'Affiliation': 'Institute for Choice, Business School, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Norman', 'Affiliation': 'Robinson Research Institute, University of Adelaide and Fertility SA, Adelaide, South Australia, Australia.'}, {'ForeName': 'Neil P', 'Initials': 'NP', 'LastName': 'Johnson', 'Affiliation': 'Robinson Research Institute, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Boothroyd', 'Affiliation': 'Greenslopes Private Hospital, Greenslopes, Queensland, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fahey', 'Affiliation': 'School of Science and Health, Western Sydney University, Penrith, New South Wales, Australia.'}]",JAMA,['10.1001/jama.2018.5336']
651,31307948,"Efficacy and safety of dolutegravir-rilpivirine for maintenance of virological suppression in adults with HIV-1: 100-week data from the randomised, open-label, phase 3 SWORD-1 and SWORD-2 studies.","BACKGROUND


Primary analyses of the SWORD-1 and SWORD-2 trials at 48 weeks showed that switching to a two-drug regimen of dolutegravir plus rilpivirine was non-inferior to continuing a standard three-drug or four-drug antiretroviral regimen for maintenance of virological suppression in people with HIV-1. Here, we present efficacy and safety data from the 100-week analysis of the trials.
METHODS


SWORD-1 and SWORD-2 are identically designed, randomised, open-label phase 3 studies at 65 centres in 13 countries and 60 centres in 11 countries, respectively. Adults aged 18 years or older who were on a standard three-drug or four-drug antiretroviral therapy (ART) and had had fewer than 50 HIV-1 RNA copies per mL of plasma for at least 6 months were randomly assigned (1:1) to 50 mg dolutegravir plus 25 mg rilpivirine orally once daily (early-switch group) or to continue their standard regimen for 52 weeks before switching to the dolutegravir plus rilpivirine combination (ie, the late-switch group). In this analysis of week 100 data, the efficacy endpoint of interest was the proportion of participants with fewer than 50 copies of HIV-1 RNA per mL of plasma (per the US Food and Drug Administration snapshot algorithm). This outcome was assessed in all randomly assigned participants who received at least one dose of the study drug. Data were analysed after the last participant completed week 100 (Sept 15, 2017) and verified through the data cutoff (Nov 21, 2017). SWORD-1 and SWORD-2 are registered with ClinicalTrials.gov, numbers NCT02429791 and NCT02422797, respectively.
FINDINGS


513 participants were randomly assigned to dolutegravir plus rilpivirine (ie, the early-switch group) and 511 to continue their standard ART regimen, 477 of whom then switched to dolutegravir plus rilpivirine at week 52 (ie, the late-switch group). At week 100, 456 (89% [95% CI 86-92]) of 513 participants in the early-switch group and 444 (93% [91-95]) of 477 in the late-switch group had fewer than 50 HIV-1 RNA copies per mL. Drug-related adverse events occurred in 103 (20%) participants in the early-switch group and 58 (12%) in the late-switch group. The most common drug-related adverse events were headache (11 participants in the early-switch group [2%] vs eight [2%] in the late-switch group) and nausea (eight [2%] vs five [1%]).
INTERPRETATION


The combination of dolutegravir plus rilpivirine sustained virological suppression of HIV-1, was associated with a low frequency of virological failure, and had a favourable safety profile, which support its use as a nucleoside reverse transcriptase inhibitor-sparing and protease inhibitor-sparing alternative to three-drug regimens that reduces overall exposure to ART.
FUNDING


ViiV Healthcare and Janssen Pharmaceutica.",2019,RNA copies per mL. Drug-related adverse events occurred in 103 (20%) participants in the early-switch group and 58 (12%) in the late-switch group.,"['65 centres in 13 countries and 60 centres in 11 countries, respectively', '513 participants', 'people with HIV-1', 'adults with HIV-1', 'Adults aged 18 years or older who were on a standard three-drug or four-drug antiretroviral therapy (ART) and had had fewer than 50 HIV-1']","['dolutegravir-rilpivirine', 'rilpivirine combination', 'dolutegravir plus 25 mg rilpivirine', 'dolutegravir plus rilpivirine']","['headache', 'nausea', 'RNA copies per mL. Drug-related adverse events']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}]","[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",513.0,0.24491,RNA copies per mL. Drug-related adverse events occurred in 103 (20%) participants in the early-switch group and 58 (12%) in the late-switch group.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aboud', 'Affiliation': 'ViiV Healthcare, Brentford, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Podzamczer', 'Affiliation': ""IDIBELL-Hospital Universitari de Bellvitge, L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'Johannes R', 'Initials': 'JR', 'LastName': 'Bogner', 'Affiliation': 'Hospital of the University of Munich, Munich, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baker', 'Affiliation': 'East Sydney Doctors, Darlinghurst, Sydney, NSW, Australia.'}, {'ForeName': 'Marie-Aude', 'Initials': 'MA', 'LastName': 'Khuong-Josses', 'Affiliation': 'CHG-Hôpital Delafontaine, Saint Denis, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Parks', 'Affiliation': 'Central West Clinical Research, St Louis, MO, USA.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Angelis', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'Lesley P', 'Initials': 'LP', 'LastName': 'Kahl', 'Affiliation': 'ViiV Healthcare, Brentford, UK. Electronic address: lesley.p.kahl@viivhealthcare.com.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Blair', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Adkison', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Matthews', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Wynne', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kati', 'Initials': 'K', 'LastName': 'Vandermeulen', 'Affiliation': 'Janssen Pharmaceutica, Beerse, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gartland', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'ViiV Healthcare, Research Triangle Park, NC, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30149-3']
652,31299067,An apparent paradox: resistance mutations in HIV-1 DNA predict improved virological responses to antiretroviral therapy.,"BACKGROUND


In sub-Saharan Africa, detecting resistance-associated mutations (RAMs) at failure of first-line ART with two NRTIs plus an NNRTI predicts improved virological responses to second-line therapy with two NRTIs plus a ritonavir-boosted PI (PI/r). This indicates residual NRTI activity in the presence of RAMs, although additional factors may contribute to the effect.
OBJECTIVES


The aim of this study was to investigate the influence of pre-existing RAMs on the outcomes of maintenance monotherapy with ritonavir-boosted darunavir within a randomized trial in Cameroon.
METHODS


RAMs were detected in HIV-1 DNA using PBMCs collected at initiation of darunavir/ritonavir monotherapy. Adherence was assessed by pill count and visual analogue scale (VAS). Predictors of virological failure (confirmed or last available viral load >400 copies/mL) were explored by logistic regression analysis. Trial name = MANET (NCT02155101).
RESULTS


After NNRTI-based therapy, participants (n = 81) had received PI/r-based therapy for a median of 3.2 years and had a confirmed viral load <60 copies/mL and a median CD4 count of 466 cells/mm3. NRTI and NNRTI RAMs were detected in 39/60 (65.0%) and 41/60 (68.3%) HIV-1 DNA sequences, respectively. Over 48 weeks of monotherapy, 16/81 (19.8%) patients experienced virological failure. After adjusting for age, HIV-1 DNA load, adherence by VAS and RAM status, virological failure was less likely with higher VAS-measured adherence (adjusted OR 0.04, 95% CI 0.01-0.37; P = 0.004) and detectable HIV-1 DNA RAMs (adjusted OR 0.15, 95% CI 0.03-0.82; P = 0.028).
CONCLUSIONS


Pre-existing NRTI and NNRTI RAMs are associated with improved virological responses to NRTI-sparing ART in sub-Saharan Africa, indicating a predictive effect that is independent of residual NRTI activity.",2019,"CONCLUSIONS


Pre-existing NRTI and NNRTI RAMs are associated with improved virological responses to NRTI-sparing ART in sub-Saharan Africa, indicating a predictive effect that is independent of residual NRTI activity.","['RAMs were detected in HIV-1 DNA using PBMCs collected at initiation of darunavir/ritonavir monotherapy', 'Cameroon']",['ritonavir-boosted darunavir'],"['detectable HIV-1 DNA RAMs', 'pill count and visual analogue scale (VAS', 'virological responses', 'HIV-1', 'virological failure', 'Adherence', 'NRTI and NNRTI RAMs', 'HIV-1 DNA load, adherence by VAS and RAM status, virological failure']","[{'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0006802', 'cui_str': 'Republic of Cameron'}]","[{'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C1435444', 'cui_str': 'darunavir'}]","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.446561,"CONCLUSIONS


Pre-existing NRTI and NNRTI RAMs are associated with improved virological responses to NRTI-sparing ART in sub-Saharan Africa, indicating a predictive effect that is independent of residual NRTI activity.","[{'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Geretti', 'Affiliation': 'Institute of Infection & Global Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Abdullahi', 'Affiliation': 'Institute of Infection & Global Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Mafotsing Fopoussi', 'Affiliation': 'Institute of Infection & Global Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bonnett', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Victoire Fokom', 'Initials': 'VF', 'LastName': 'Defo', 'Affiliation': 'Chantal Biya International Reference Centre for Research on HIV/AIDS Prevention & Management (CIRCB), Yaoundé, Cameroon.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Moudourou', 'Affiliation': 'Chantal Biya International Reference Centre for Research on HIV/AIDS Prevention & Management (CIRCB), Yaoundé, Cameroon.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Fokam', 'Affiliation': 'Chantal Biya International Reference Centre for Research on HIV/AIDS Prevention & Management (CIRCB), Yaoundé, Cameroon.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kouanfack', 'Affiliation': 'Hôpital Central Yaoundé, Ministry of Public Health, Yaoundé, Cameroon.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Torimiro', 'Affiliation': 'Chantal Biya International Reference Centre for Research on HIV/AIDS Prevention & Management (CIRCB), Yaoundé, Cameroon.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz264']
653,31298171,Who will benefit from computerized cognitive remediation therapy? Evidence from a multisite randomized controlled study in schizophrenia.,"BACKGROUND


Computerized cognitive remediation therapy (CCRT) is generally effective for the cognitive deficits of schizophrenia. However, there is much uncertainty about what factors mediate or moderate effectiveness and are therefore important to personalize treatment and boost its effects.
METHOD


In total, 311 Chinese inpatients with Diagnostic and Statistical Manual of Mental Disorders-IV schizophrenia were randomized to receive CCRT or Active control for 12 weeks with four to five sessions per week. All participants were assessed at baseline, post-treatment and 3-month follow-up. The outcomes were cognition, clinical symptoms and functional outcomes.
RESULTS


There was a significant benefit in the MATRICS Consensus Cognitive Battery (MCCB) total score for CCRT (F1,258 = 5.62; p = 0.02; effect size was 0.27, 95% confidence interval 0.04-0.49). There were no specific moderators of CCRT improvements. However, across both groups, Wisconsin Card Sort Test improvement mediated a positive effect on functional capacity and Digit Span benefit mediated decreases in positive symptoms. In exploratory analyses younger and older participants showed cognitive improvements but on different tests (younger on Symbol Coding Test, while older on the Spatial Span Test). Only the older age group showed MSCEIT benefits at post-treatment. In addition, cognition at baseline negatively correlated with cognitive improvement and those whose MCCB baseline total score was around 31 seem to derive the most benefit.
CONCLUSIONS


CCRT can improve the cognitive function of patients with schizophrenia. Changes in cognitive outcomes also contributed to improvements in functional outcomes either directly or solely in the context of CCRT. Age and the basic cognitive level of the participants seem to affect the cognitive benefits from CCRT.",2020,"There was a significant benefit in the MATRICS Consensus Cognitive Battery (MCCB) total score for CCRT (F1,258 = 5.62; p = 0.02; effect size was 0.27, 95% confidence interval 0.04-0.49).","['311 Chinese inpatients with Diagnostic and Statistical Manual of Mental Disorders-IV schizophrenia', 'patients with schizophrenia']","['CCRT or Active control', 'Computerized cognitive remediation therapy (CCRT', 'CCRT']","['MSCEIT benefits', 'functional capacity and Digit Span benefit', 'cognitive improvements', 'cognition, clinical symptoms and functional outcomes', 'cognitive function', 'Consensus Cognitive Battery (MCCB) total score for CCRT', 'MCCB baseline total score']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",311.0,0.0451081,"There was a significant benefit in the MATRICS Consensus Cognitive Battery (MCCB) total score for CCRT (F1,258 = 5.62; p = 0.02; effect size was 0.27, 95% confidence interval 0.04-0.49).","[{'ForeName': 'Shuping', 'Initials': 'S', 'LastName': 'Tan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Hongzhen', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Fude', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Zhiren', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Fan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Beijing Anding Hospital of Capital Medical University, Beijing100088, P.R. China.'}, {'ForeName': 'Zhanjiang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Beijing Anding Hospital of Capital Medical University, Beijing100088, P.R. China.'}, {'ForeName': 'Wenxiang', 'Initials': 'W', 'LastName': 'Quan', 'Affiliation': 'Institute of Mental Health, Peking University, Beijing100191, P.R. China.'}, {'ForeName': 'Xiangqun', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Institute of Mental Health, Peking University, Beijing100191, P.R. China.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Reeder', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, LondonSE5 8AF, UK.""}, {'ForeName': 'Dongfeng', 'Initials': 'D', 'LastName': 'Zhou', 'Affiliation': 'Institute of Mental Health, Peking University, Beijing100191, P.R. China.'}, {'ForeName': 'Yizhuang', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University HuiLongGuan Clinical Medical School, Beijing100096, P.R. China.'}, {'ForeName': 'Til', 'Initials': 'T', 'LastName': 'Wykes', 'Affiliation': ""Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, LondonSE5 8AF, UK.""}]",Psychological medicine,['10.1017/S0033291719001594']
654,31247674,GABA A  receptors modulate sympathetic vasomotor outflow and the pressor response to skeletal muscle metaboreflex activation in humans.,"KEY POINTS


The activation of the group III/IV skeletal muscle afferents is one of the principal mediators of cardiovascular responses to exercise; however, the neuronal circuitry mechanisms that are involved during the activation of group III/IV muscle afferents in humans remain unknown. Recently, we showed that GABAergic mechanisms are involved in the cardiac vagal withdrawal during the activation of mechanically sensitive (predominantly mediated by group III fibres) skeletal muscle afferents in humans. In the present study, we found that increases in muscle sympathetic nerve activity and mean blood pressure during isometric handgrip exercise and postexercise ischaemia were significantly greater after the oral administration of diazepam, a benzodiazepine that increases GABA A  activity, but not after placebo administration in young healthy subjects. These findings indicate for the first time that GABA A  receptors modulate sympathetic vasomotor outflow and the pressor responses to activation of metabolically sensitive (predominantly mediated by group IV fibres) skeletal muscle afferents in humans.
ABSTRACT


Animal studies have indicated that GABA A  receptors are involved in the neuronal circuitry of the group III/IV skeletal muscle afferent activation-induced neurocardiovascular responses to exercise. In the present study, we aimed to determine whether GABA A  receptors modulate the neurocardiovascular responses to activation of metabolically sensitive (predominantly mediated by group IV fibres) skeletal muscle afferents in humans. In a randomized, double-blinded, placebo-controlled and cross-over design, 17 healthy subjects (eight women) performed 2 min of ischaemic isometric handgrip exercise at 30% of the maximal voluntary contraction followed by 2 min of postexercise ischaemia (PEI). Muscle sympathetic nerve activity (MSNA), blood pressure (BP) and heart rate (HR) were continuously measured and trials were conducted before and 60 min after the oral administration of either placebo or diazepam (10 mg), a benzodiazepine that enhances GABA A  activity. At rest, MSNA was reduced, whereas HR and BP did not change after diazepam administration. During ischaemic isometric handgrip, greater MSNA (pre: ∆13 ± 9 bursts min -1  vs. post: ∆29 ± 15 bursts min -1  , P < 0.001), HR (pre: ∆23 ± 11 beats min -1  vs. post: ∆31 ± 17 beats min -1  , P < 0.01) and mean BP (pre: ∆33 ± 12 mmHg vs. post: ∆37 ± 12 mmHg, P < 0.01) responses were observed after diazepam. During PEI, MSNA and mean BP remained elevated from baseline before diazepam (∆10 ± 8 bursts min -1  and ∆25 ± 14 mmHg, respectively) and these elevations were increased after diazepam (∆17 ± 12 bursts min -1  and ∆28 ± 13 mmHg, respectively) (P ≤ 0.05). Importantly, placebo pill had no effect on neural, cardiac and pressor responses. These findings demonstrate for the first time that GABA A  receptors modulate MSNA and the pressor responses to skeletal muscle metaboreflex activation in humans.",2019,"At rest, MSNA was reduced while HR and BP did not change after diazepam administration.","['young healthy subjects', 'humans', '17 healthy subjects (8 women']","['placebo', 'benzodiazepine', 'diazepam', 'placebo or diazepam', 'performed 2\xa0min of ischemic isometric handgrip (IHG) exercise at 30% of the maximal voluntary contraction followed by 2-min of postexercise ischemia (PEI']","['neural, cardiac and pressor responses', 'HR and BP', 'mean BP', 'Muscle sympathetic nerve activity (MSNA), blood pressure (BP) and heart rate (HR', 'muscle sympathetic nerve activity and mean blood pressure during isometric handgrip exercise and postexercise ischemia']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]",17.0,0.0993491,"At rest, MSNA was reduced while HR and BP did not change after diazepam administration.","[{'ForeName': 'André L', 'Initials': 'AL', 'LastName': 'Teixeira', 'Affiliation': 'NeuroV̇ASQ̇\xa0-\xa0Integrative Physiology Laboratory, Faculty of Physical Education, University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Igor A', 'Initials': 'IA', 'LastName': 'Fernandes', 'Affiliation': 'NeuroV̇ASQ̇\xa0-\xa0Integrative Physiology Laboratory, Faculty of Physical Education, University of Brasília, Brasília, DF, Brazil.'}, {'ForeName': 'Lauro C', 'Initials': 'LC', 'LastName': 'Vianna', 'Affiliation': 'NeuroV̇ASQ̇\xa0-\xa0Integrative Physiology Laboratory, Faculty of Physical Education, University of Brasília, Brasília, DF, Brazil.'}]",The Journal of physiology,['10.1113/JP277929']
655,31287147,[Intermittent theta-burst transcranial magnetic stimulation for the treatment of spasticity in patients with recurring multiple sclerosis: the results of a double-blind randomised clinical trial].,"AIM


It has been suggested that the repetitive transcranial magnetic stimulation could be useful as a non-pharmacological treatment for spasticity. The aim of this study was to evaluate the clinical and neurophysiological effects of high-frequency intermittent theta burst stimulation (iTBS) on lower limb spasticity in patients with relapsing multiple sclerosis in a randomized, double-blind placebo controlled trial.
PATIENTS AND METHODS


Seventeen patients in the remitting phase of the disease were randomly allocated to sham or magnetic therapy group and underwent iTBS over contralateral motor cortex of the most affected leg once a day for two weeks. Each session consisted of 10 bursts containing three pulses at 50 Hz repeated at 200 ms intervals (5 Hz) every 10 s for a total of 600 stimuli. The iTBS effect was assessed by using clinical (such as the Modified Ashworth Scale) and neuro-physiological (H/M amplitude ratio and cortical silent period duration) parameters.
RESULTS


Two-week iTBS over motor cortex of the most affected leg did not produce any significant clinical effect on spasticity. However, it decreases the H/M amplitude ratio and increases duration of cortical silent period but not significantly, in patients with relapsing multiple sclerosis.
CONCLUSION


The stimulation protocol used in this study does not have significant therapeutic effect. Therefore, we do recommend further studies as neurophysiological changes were evident.",2019,"However, it decreases the H/M amplitude ratio and increases duration of cortical silent period but not significantly, in patients with relapsing multiple sclerosis.
","['patients with relapsing multiple sclerosis', 'patients with recurring multiple sclerosis', 'Seventeen patients in the remitting phase of the disease']","['placebo', 'high-frequency intermittent theta burst stimulation (iTBS', 'Intermittent theta-burst transcranial magnetic stimulation', 'repetitive transcranial magnetic stimulation', 'sham or magnetic therapy group and underwent iTBS']","['H/M amplitude ratio and increases duration of cortical silent period', 'spasticity', 'iTBS effect', 'Modified Ashworth Scale) and neuro-physiological (H/M amplitude ratio and cortical silent period duration) parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0872210', 'cui_str': 'Magnetic therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",600.0,0.344532,"However, it decreases the H/M amplitude ratio and increases duration of cortical silent period but not significantly, in patients with relapsing multiple sclerosis.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Dieguez-Varela', 'Affiliation': 'Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lion-Vazquez', 'Affiliation': 'Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Fraga-Bau', 'Affiliation': 'Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Rodriguez-Acevedo', 'Affiliation': 'Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rodriguez-Sanchez', 'Affiliation': 'Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Collazo-Dieguez', 'Affiliation': 'Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Pereira-Martinez', 'Affiliation': 'Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Salgado-Barreira', 'Affiliation': 'Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Alvarez-Rodriguez', 'Affiliation': 'Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vicente-Alba', 'Affiliation': 'Complejo Hospitalario Universitario de Vigo, Vigo, Espana.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Munoz', 'Affiliation': 'Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Fernandez', 'Affiliation': 'Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Ribeiro', 'Affiliation': 'Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Midaglia', 'Affiliation': 'Complejo Hospitalario Universitario de Vigo, 36200 Vigo, Espana.'}]",Revista de neurologia,['10.33588/rn.6902.2018275']
656,31287236,"Effects of Strong CYP2C8 or CYP3A Inhibition and CYP3A Induction on the Pharmacokinetics of Brigatinib, an Oral Anaplastic Lymphoma Kinase Inhibitor, in Healthy Volunteers.","In vitro data support involvement of cytochrome P450 (CYP)2C8 and CYP3A4 in the metabolism of the anaplastic lymphoma kinase inhibitor brigatinib. A 3-arm, open-label, randomized, single-dose, fixed-sequence crossover study was conducted to characterize the effects of the strong inhibitors gemfibrozil (of CYP2C8) and itraconazole (of CYP3A) and the strong inducer rifampin (of CYP3A) on the single-dose pharmacokinetics of brigatinib. Healthy subjects (n = 20 per arm) were administered a single dose of brigatinib (90 mg, arms 1 and 2; 180 mg, arm 3) alone in treatment period 1 and coadministered with multiple doses of gemfibrozil 600 mg twice daily (BID; arm 1), itraconazole 200 mg BID (arm 2), or rifampin 600 mg daily (QD; arm 3) in period 2. Compared with brigatinib alone, coadministration of gemfibrozil with brigatinib did not meaningfully affect brigatinib area under the plasma concentration-time curve (AUC 0-inf  ; geometric least-squares mean [LSM] ratio [90%CI], 0.88 [0.83-0.94]). Coadministration of itraconazole with brigatinib increased AUC 0-inf  (geometric LSM ratio [90%CI], 2.01 [1.84-2.20]). Coadministration of rifampin with brigatinib substantially reduced AUC 0-inf  (geometric LSM ratio [90%CI], 0.20 [0.18-0.21]) compared with brigatinib alone. The treatments were generally tolerated. Based on these results, strong CYP3A inhibitors and inducers should be avoided during brigatinib treatment. If concomitant use of a strong CYP3A inhibitor is unavoidable, the results of this study support a dose reduction of brigatinib by approximately 50%. Furthermore, CYP2C8 is not a meaningful determinant of brigatinib clearance, and no dose modifications are needed during coadministration of brigatinib with CYP2C8 inhibitors.",2020,"Compared with brigatinib alone, coadministration of gemfibrozil with brigatinib did not meaningfully affect brigatinib area under the plasma concentration-time curve (AUC 0-inf  ; geometric least-squares mean [LSM] ratio [90%CI], 0.88 [0.83-0.94]).","['Healthy subjects (n\xa0=\xa020 per arm', 'Healthy Volunteers']","['brigatinib', 'gemfibrozil (of CYP2C8) and itraconazole (of CYP3A) and the strong inducer rifampin (of CYP3A', 'rifampin', 'itraconazole 200\xa0mg BID (arm 2), or rifampin 600\xa0mg daily (QD', 'Strong CYP2C8 or CYP3A Inhibition and CYP3A Induction', 'itraconazole', 'cytochrome P450', 'gemfibrozil']","['brigatinib area under the plasma concentration-time curve', 'tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C4287815', 'cui_str': 'brigatinib'}, {'cui': 'C0017245', 'cui_str': 'Gemfibrozil'}, {'cui': 'C1382144', 'cui_str': 'CYP2C8'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome P-450 CYP3A'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C3249440', 'cui_str': 'Itraconazole 200 MG [Onmel]'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4301185', 'cui_str': 'Rifampin 600 MG [Rifadin]'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0010762', 'cui_str': 'Cytochrome P-450 Families'}]","[{'cui': 'C4287815', 'cui_str': 'brigatinib'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",,0.0338711,"Compared with brigatinib alone, coadministration of gemfibrozil with brigatinib did not meaningfully affect brigatinib area under the plasma concentration-time curve (AUC 0-inf  ; geometric least-squares mean [LSM] ratio [90%CI], 0.88 [0.83-0.94]).","[{'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Tugnait', 'Affiliation': 'ARIAD Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, MA, USA.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Gupta', 'Affiliation': 'Millennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, MA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hanley', 'Affiliation': 'Millennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, MA, USA.'}, {'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Sonnichsen', 'Affiliation': 'Sonnichsen Pharmaceutical Associates LLC, Collegeville, PA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kerstein', 'Affiliation': 'ARIAD Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, MA, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Dorer', 'Affiliation': 'ARIAD Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, MA, USA.'}, {'ForeName': 'Karthik', 'Initials': 'K', 'LastName': 'Venkatakrishnan', 'Affiliation': 'Millennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, MA, USA.'}, {'ForeName': 'Narayana', 'Initials': 'N', 'LastName': 'Narasimhan', 'Affiliation': 'ARIAD Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, MA, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.723']
657,31904325,Treatment of Notalgia Paresthetica with Bee Venom and Capsaicin: A Pilot Study with 20 Patients.,"Notalgia paresthetica (NP) is a common clinical disorder characterized by hyperpigmentation, pruritus, paresthesia, and/or pain, located on the back. There is no effective treatment for patients with NP. We investigated the efficacy of a product containing bee venom (0.04%) and capsaicin (0.025%) for treating NP. Twenty patients (10 men and 10 women) with NP were included in this open-label pilot study. A biopsy was performed for each patient to exclude other dermatologic diseases. The patients were asked to apply the product to the pruritic areas once daily for 2 weeks. No other product was used during the study. The Visual Analogue Scale (VAS) score was used to evaluate the efficacy of the product. VAS scores before and after treatment were statistically different (  p  = 0.005). The pretreatment median of VAS score was 8 (7-10) (8.20 ± 1.03), while the median after treatment was 3 (1-7) (3.40 ± 1.71). The product containing bee venom and capsaicin is effective in treating  NP. A double-blind and placebo-controlled study has been planned and initiated with a greater sample size.",2019,VAS scores before and after treatment were statistically different (  p  = 0.005).,"['patients with NP', '20 Patients', 'Twenty patients (10 men and 10 women) with NP']","['Notalgia paresthetica (NP', 'Notalgia Paresthetica with Bee Venom and Capsaicin', 'placebo', 'capsaicin']","['pretreatment median of VAS score', 'VAS scores', 'Visual Analogue Scale (VAS) score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0457010', 'cui_str': 'Notalgia paresthetica'}, {'cui': 'C0004920', 'cui_str': 'Apis Venoms'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",20.0,0.0787908,VAS scores before and after treatment were statistically different (  p  = 0.005).,"[{'ForeName': 'Engin', 'Initials': 'E', 'LastName': 'Şenel', 'Affiliation': 'Faculty of Medicine, Department of Dermatology and Venereology, Hitit University, Çorum, Turkey.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Holt', 'Affiliation': 'School of Biological Sciences, Victoria University of Wellington, Wellington, New Zealand.'}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Demir', 'Affiliation': 'Traditional and Complementary Medicine Application and Research Center, Hitit University, Çorum, Turkey.'}]",Skinmed,[]
658,31820551,Reproductive Life Planning and Contraceptive Action Planning for Privately Insured Women: The MyNewOptions Study.,"CONTEXT


Although reproductive life planning (RLP) is recommended in federal and clinical guidelines and may help insured women make personalized contraceptive choices, it has not been systematically evaluated for effectiveness.
METHODS


In 2014, some 984 privately insured women aged 18-40 who were not intending to become pregnant in the next year were randomly assigned to receive RLP, RLP with contraceptive action planning (RLP+) or information only (the control group). Women's contraceptive use, prescription contraceptive use, method adherence, switching to a more effective method, method satisfaction and contraceptive self-efficacy were assessed at six-month intervals during the two-year follow-up period. Differences between groups were identified using binomial logistic regression, linear regression and generalized estimating equation models.
RESULTS


During the follow-up period, the proportion of women using any contraceptive method increased from 89% to 96%, and the proportion using a long-acting reversible contraceptive or sterilization increased from 8% to 19%. Contraceptive adherence was high (72-76%) in all three groups. In regression models, the sole significant finding was that women in the RLP+ group were more likely than those in the RLP group to use a prescription method (odds ratio, 1.3). No differences were evident between the intervention groups and the control group in overall contraceptive use, contraceptive adherence, switching to a more effective method, method satisfaction or contraceptive self-efficacy.
CONCLUSIONS


The study does not provide evidence that web-based RLP influences contraceptive behaviors in insured women outside of the clinical setting. Further research is needed to identify strategies to help women of reproductive age identify contraceptive methods that meet their needs and preferences.",2019,"No differences were evident between the intervention groups and the control group in overall contraceptive use, contraceptive adherence, switching to a more effective method, method satisfaction or contraceptive self-efficacy.
","['Privately Insured Women', 'In 2014, some 984 privately insured women aged 18-40 who were not intending to become pregnant in the next year']","['RLP', 'RLP, RLP with contraceptive action planning (RLP', 'Reproductive Life Planning and Contraceptive Action Planning', 'reproductive life planning (RLP']","['Contraceptive adherence', 'overall contraceptive use, contraceptive adherence, switching to a more effective method, method satisfaction or contraceptive self-efficacy', 'proportion using a long-acting reversible contraceptive or sterilization', 'proportion of women using any contraceptive method']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0362065', 'cui_str': 'Sterilization'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}]",,0.0485212,"No differences were evident between the intervention groups and the control group in overall contraceptive use, contraceptive adherence, switching to a more effective method, method satisfaction or contraceptive self-efficacy.
","[{'ForeName': 'Cynthia H', 'Initials': 'CH', 'LastName': 'Chuang', 'Affiliation': 'Department of Medicine and Public Health Sciences, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Carol S', 'Initials': 'CS', 'LastName': 'Weisman', 'Affiliation': 'Departments of Public Health Sciences and Obstetrics and Gynecology, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Diana L', 'Initials': 'DL', 'LastName': 'Velott', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lehman', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Vernon M', 'Initials': 'VM', 'LastName': 'Chinchilli', 'Affiliation': 'Department of Public Health Sciences, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Erica B', 'Initials': 'EB', 'LastName': 'Francis', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Merry-K', 'Initials': 'MK', 'LastName': 'Moos', 'Affiliation': 'Department of Health Psychology, University of Manchester, Manchester, UK.'}, {'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Sciamanna', 'Affiliation': 'Department of Medicine and Public Health Sciences, Penn State College of Medicine, Hershey, PA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Armitage', 'Affiliation': 'Department of Health Psychology, University of Manchester, Manchester, UK.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey, PA.'}]",Perspectives on sexual and reproductive health,['10.1363/psrh.12123']
659,31670173,The effectiveness of a nurse-led exercise and health education informatics program on exercise capacity and quality of life among cancer survivors after esophagectomy: A randomized controlled trial.,"BACKGROUND


Esophagectomy is the primary surgical treatment for esophageal cancer. However, patients often experience a decrease in physical activity, poor nutrition, and a reduction in quality of life following surgery.
OBJECTIVES


The aim of this study was to examine the effects of an exercise and nursing education health informatics program on quality of life, exercise capacity, and nutrition among patients following esophagectomy for esophageal cancer.
DESIGN


A randomized controlled trial.
SETTINGS AND METHODS


Patients who had undergone an esophagectomy for cancer were recruited by purposive sampling from a medical center in Taiwan. Patients who met inclusion criteria and agreed to participate (N = 88) were randomly assigned to an exercise informatics program (intervention group, n = 44) or usual post-surgery care (control group, n = 44). Quality of life was assessed at baseline and 1, 3, and 6 months after discharge. Secondary outcomes of nutrition (albumin, body mass index), and exercise capacity (maximal oxygen uptake, the six-minute walking test) were conducted at baseline and 3 months following discharge. Differences in quality of life, nutrition and exercise capacity between the two groups were analyzed using generalized estimating equations.
RESULTS


Analysis demonstrated significant improvements in outcome measures following hospital discharge for the intervention group compared to controls. Measures of quality of life were significantly better for the intervention group and varied with time following discharge. Functional scores for physical (1 and 3 months), role (1, 3, and 6 months), emotional (1 month), social (3 months) and global health (3 months) were significantly higher than controls. Cancer-related subscales improved for insomnia (1 and 3 months) and nausea/vomiting (3 and 6 months). Esophageal cancer-specific symptoms improved for dry mouth (1 month), dysphagia (3 months), and loss of taste (1 and 6 months). Three months following discharge, levels of albumin were significantly higher for the intervention group compared to controls (β=0.32, 95% CI 0.09, 0.54, p < .01); body mass index did not differ between groups. Exercise capacity was also significantly better; the intervention group had higher maximal oxygen consumption (β=2.61, 95% CI 1.54, 3.69, p < .001) and greater distance on the six-minute walking test (β=83.30, 95% CI 52.60, 113.99, p < .001).
CONCLUSION


The intervention group experienced significant improvements in nutrition, exercise capacity, and variables related to quality of life. These findings suggest a nurse-led exercise and health education informatics program should be implemented for survivors of esophagectomy prior to hospital discharge.",2020,"Exercise capacity was also significantly better; the intervention group had higher maximal oxygen consumption (β=2.61, 95% CI 1.54, 3.69, p < .001) and greater distance on the six-minute walking test (β=83.30, 95% CI 52.60, 113.99, p < .001).
","['Patients who had undergone an esophagectomy for cancer were recruited by purposive sampling from a medical center in Taiwan', 'patients following esophagectomy for esophageal cancer', 'cancer survivors after esophagectomy', 'esophageal cancer', 'Patients who met inclusion criteria and agreed to participate (N\u202f=\u202f88']","['exercise and nursing education health informatics program', 'exercise informatics program (intervention group, n\u202f=\u202f44) or usual post-surgery care (control group, n\u202f=\u202f44', 'nurse-led exercise and health education informatics program']","['Exercise capacity', 'Quality of life', 'quality of life', 'nutrition, exercise capacity, and variables related to quality of life', 'nutrition (albumin, body mass index), and exercise capacity (maximal oxygen uptake, the six-minute walking test', 'quality of life, nutrition and exercise capacity', 'emotional (1 month), social (3 months) and global health', 'body mass index', 'maximal oxygen consumption', 'Esophageal cancer-specific symptoms', 'levels of albumin', 'hospital discharge', 'quality of life, exercise capacity, and nutrition', 'exercise capacity and quality of life', 'physical activity, poor nutrition', 'nausea/vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013636', 'cui_str': 'Education, Nursing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C4544573', 'cui_str': 'Surgery care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018701'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034380'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}]",,0.171659,"Exercise capacity was also significantly better; the intervention group had higher maximal oxygen consumption (β=2.61, 95% CI 1.54, 3.69, p < .001) and greater distance on the six-minute walking test (β=83.30, 95% CI 52.60, 113.99, p < .001).
","[{'ForeName': 'Yu-Ling', 'Initials': 'YL', 'LastName': 'Chang', 'Affiliation': 'School of Nursing, College of Medicine, Chang Gung University, Tao-Yuan, Taiwan. Electronic address: ylchang@mail.cgu.edu.tw.'}, {'ForeName': 'Yun-Fang', 'Initials': 'YF', 'LastName': 'Tsai', 'Affiliation': 'School of Nursing, College of Medicine, Chang Gung University, Tao-Yuan, Taiwan; Department of Nursing, Chang Gung University of Science and Technology, Tao-Yuan, Taiwan; Department of Psychiatry, Chang Gung Memorial Hospital in Keelung, Keelung, Taiwan. Electronic address: yftsai@mail.cgu.edu.tw.'}, {'ForeName': 'Chien-Lung', 'Initials': 'CL', 'LastName': 'Hsu', 'Affiliation': 'Department of Information Management, College of Management, Chang Gung University, Tao-Yuan, Taiwan. Electronic address: clhsu@mail.cgu.edu.tw.'}, {'ForeName': 'Yin-Kai', 'Initials': 'YK', 'LastName': 'Chao', 'Affiliation': 'Division of Thoracic Surgery, Chang Gung Memorial Hospital-Linkou, Tao-Yuan, Taiwan; College of Medicine, Chang Gung University, Tao-Yuan, Taiwan. Electronic address: chaoyk@cgmh.org.tw.'}, {'ForeName': 'Chih-Chin', 'Initials': 'CC', 'LastName': 'Hsu', 'Affiliation': 'College of Medicine, Chang Gung University, Tao-Yuan, Taiwan; Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Keelung, Keelung, Taiwan. Electronic address: steele@cgmh.org.tw.'}, {'ForeName': 'Kuan-Chia', 'Initials': 'KC', 'LastName': 'Lin', 'Affiliation': 'Institute of Hospital and Health Care Administration, Community Medicine Research Center, Preventive Medicine Research Center, National Yang-Ming University, Taipei, Taiwan. Electronic address: kuanchia@ym.edu.tw.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2019.103418']
660,31122876,Consistent use of bedtime parenting strategies mediates the effects of sleep education on child sleep: secondary findings from an early-life randomized controlled trial.,"OBJECTIVE


Using data from a randomized controlled trial, this study investigated whether parent's consistent use of recommended bedtime strategies with infants was a mediating mechanism for improved child sleep.
METHODS


Expectant mothers were allocated to 4 groups: usual care (Control); additional support regarding Food, (physical) Activity, and Breastfeeding (FAB); advice on infant sleep through 1 group educational session during the antenatal period and 1 home visit when the child was 3 weeks of age (Sleep), or both FAB and Sleep interventions (Combination). An index relating to parent's consistent use of strategies to encourage infant sleep self-settling was developed from data collected when infants were 4 and 6 months of age. Child sleep self-control was measured at 3.5 years of age through a behavior rating scale. Child overnight sleep duration was measured using accelerometers at 1, 2, 3.5, and 5 years of age. Analyses examined whether any association between intervention group and child sleep self-control or sleep duration was mediated by consistent use of bedtime strategies at 4 and 6 months.
RESULTS


Compared to Controls, Sleep group parents had significantly higher odds of using more intervention strategies consistently (1.63; 95% confidence interval [CI] 1.14-2.33), as did Combination group parents (1.45; 95% CI 1.01-2.07). Consistent strategy use was significantly associated with a decrease in child bedtime behavioral difficulties (0.97; 95% CI 0.95-0.98) and increased sleep duration (0.152; SE = 0.017). Sleep group assignment reduced child sleep self-control difficulties and improved sleep duration indirectly via parent's consistent use of bedtime strategies.
DISCUSSION


Consistent use of appropriate bedtime strategies in infancy is an important factor that influences child sleep self-control in later development.",2019,"Sleep group assignment reduced child sleep self-control difficulties and improved sleep duration indirectly via parent's consistent use of bedtime strategies.
","['Expectant mothers', 'child sleep']","['usual care (Control); additional support regarding Food, (physical) Activity, and Breastfeeding (FAB); advice on infant sleep through 1 group educational session during the antenatal period and 1 home visit when the child was 3\u202fweeks of age (Sleep), or both FAB and Sleep interventions (Combination']","['child bedtime behavioral difficulties', 'Child overnight sleep duration', 'child sleep self-control difficulties and improved sleep duration', 'Child sleep self-control', 'child sleep self-control or sleep duration', 'sleep duration']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",,0.0810924,"Sleep group assignment reduced child sleep self-control difficulties and improved sleep duration indirectly via parent's consistent use of bedtime strategies.
","[{'ForeName': 'Burt', 'Initials': 'B', 'LastName': 'Hatch', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago. Electronic address: bhatch@ucdavis.edu.""}, {'ForeName': 'Barbara C', 'Initials': 'BC', 'LastName': 'Galland', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago.""}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Gray', 'Affiliation': 'Biostatistics Unit, Dunedin School of Medicine, University of Otago.'}, {'ForeName': 'Rachael W', 'Initials': 'RW', 'LastName': 'Taylor', 'Affiliation': 'Department of Medicine, Dunedin School of Medicine.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sayers', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lawrence', 'Affiliation': ""Department of Women's and Children's Health, Dunedin School of Medicine, University of Otago.""}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Taylor', 'Affiliation': ""Dean's Department, Dunedin School of Medicine, University of Otago. Electronic address: barry.taylor@otago.ac.nz.""}]",Sleep health,['10.1016/j.sleh.2019.03.002']
661,31801872,"Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial.","OBJECTIVE


This trial compared the efficacy and safety of transarterial chemoembolisation (TACE) plus sorafenib with TACE alone using a newly established TACE-specific endpoint and pre-treatment of sorafenib before initial TACE.
DESIGN


Patients with unresectable hepatocellular carcinoma (HCC) were randomised to TACE plus sorafenib (n=80) or TACE alone (n=76). Patients in the combination group received sorafenib 400 mg once daily for 2-3 weeks before TACE, followed by 800 mg once daily during on-demand conventional TACE sessions until time to untreatable (unTACEable) progression (TTUP), defined as untreatable tumour progression, transient deterioration to Child-Pugh C or appearance of vascular invasion/extrahepatic spread. Co-primary endpoints were progression-free survival (PFS), which is not a conventional one but defined as TTUP, or time to any cause of death plus overall survival (OS). Multiplicity was adjusted by gatekeeping hierarchical testing.
RESULTS


Median PFS was significantly longer in the TACE plus sorafenib than in the TACE alone group (25.2 vs 13.5 months; p=0.006). OS was not analysed because only 73.6% of OS events were reached. Median TTUP (26.7 vs 20.6 months; p=0.02) was also significantly longer in the TACE plus sorafenib group. OS at 1 year and 2 years in TACE plus sorafenib group and TACE alone group were 96.2% and 82.7% and 77.2% and 64.6%, respectively. There were no unexpected toxicities.
CONCLUSION


TACE plus sorafenib significantly improved PFS over TACE alone in patients with unresectable HCC. Adverse events were consistent with those of previous TACE combination trials.
TRIAL REGISTRATION NUMBER


NCT01217034.",2020,"OS at 1 year and 2 years in TACE plus sorafenib group and TACE alone group were 96.2% and 82.7% and 77.2% and 64.6%, respectively.","['patients with unresectable HCC', 'patients with hepatocellular carcinoma', 'Patients with unresectable hepatocellular carcinoma (HCC']","['transarterial chemoembolisation (TACE) plus sorafenib', 'sorafenib 400\u2009mg once daily for 2-3 weeks before TACE, followed by 800\u2009mg once daily during on-demand conventional TACE sessions until time to untreatable (unTACEable) progression (TTUP', 'transarterial chemoembolisation (TACE) plus sorafenib with TACE', 'TACE', 'Median TTUP', 'TACE alone', 'TACE plus sorafenib']","['toxicities', 'TTUP, or time to any cause of death plus overall survival (OS', 'progression-free survival (PFS', 'efficacy and safety', 'Adverse events', 'PFS', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C0522522', 'cui_str': 'Transarterial approach (qualifier value)'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0529196', 'cui_str': 'ADAM-17 Protein'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0007465', 'cui_str': 'Cause of Death'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0496813,"OS at 1 year and 2 years in TACE plus sorafenib group and TACE alone group were 96.2% and 82.7% and 77.2% and 64.6%, respectively.","[{'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan m-kudo@med.kindai.ac.jp.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Ueshima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Torimura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Nobukazu', 'Initials': 'N', 'LastName': 'Tanabe', 'Affiliation': 'Department of Gastroenterology, National Hospital Organisation Sendai Medical Center, Sendai, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Aikata', 'Affiliation': 'Department of Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Namiki', 'Initials': 'N', 'LastName': 'Izumi', 'Affiliation': 'Department of Gastroenterology, Musashino Red Cross Hospital, Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube-Yamaguchi, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Nojiri', 'Affiliation': 'Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Hino', 'Affiliation': 'Department of Hepatology and Pancreatology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Hidetaka', 'Initials': 'H', 'LastName': 'Tsumura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Teiji', 'Initials': 'T', 'LastName': 'Kuzuya', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Isoda', 'Affiliation': 'Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.'}, {'ForeName': 'Kohichiroh', 'Initials': 'K', 'LastName': 'Yasui', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Aino', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Social Insurance Tagawa Hospital, Tagawa, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Ido', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kawabe', 'Affiliation': 'Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakao', 'Affiliation': 'Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Wada', 'Affiliation': 'Department of Hepato-Biliary-Pancreatic Surgery, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yokosuka', 'Affiliation': 'Department of Gastroenterology, School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Yoshimura', 'Affiliation': 'Center for Integrated Medical Research, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': 'Department of Medical Oncology, Kyorin University Faculty of Medicine, Mitaka, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kokudo', 'Affiliation': 'Department of Surgery, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiwamu', 'Initials': 'K', 'LastName': 'Okita', 'Affiliation': 'Deapartment of Medicine, Shunan Memorial Hospital, Kudamatsu, Yamaguchi, Japan.'}, {'ForeName': 'Philip James', 'Initials': 'PJ', 'LastName': 'Johnson', 'Affiliation': 'Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Arai', 'Affiliation': 'Department of Diagnostic Radiology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gut,['10.1136/gutjnl-2019-318934']
662,31274197,"A Multicenter, Randomized, Placebo-Controlled Study of Pseudoephedrine for the Temporary Relief of Nasal Congestion in Children With the Common Cold.","This multicenter, double-blind, placebo-controlled, randomized study was designed to evaluate the efficacy and safety of pseudoephedrine hydrochloride 30-mg tablets in children aged 6 to 11 years for the temporary relief of nasal congestion due to the common cold. The primary efficacy end point was the weighted sum of the change from baseline in instantaneous nasal congestion severity score over the period from 1 to 8 hours following the first dose of study drug on day 1. Safety assessments included adverse events, sleepiness ratings, and vital signs. Pseudoephedrine was superior to placebo in reducing instantaneous nasal congestion severity in pediatric children over the first 8 hours after dosing on day 1 (least squares mean difference between treatment groups was 1.2; P = .029). Overall, secondary end points associated with nasal congestion were supportive on day 1, whereas secondary end points on day 2 were only numerically favorable. Somnolence was reported in a greater percentage of children on pseudoephedrine compared to placebo (71.9% vs 63.9%), while similar percentages of children in the same respective groups reported insomnia (34.4% and 38.9%) and nervousness (20.0% and 23.6%).Pseudoephedrine provides temporary relief of nasal congestion associated with the common cold in children 6 to <12 years of age at the current over-the-counter monograph dose. Multiple dosing of pseudoephedrine for up to 7 days, when given as needed for symptom relief, was generally safe in this population of children with the common cold.",2019,Pseudoephedrine was superior to placebo in reducing instantaneous nasal congestion severity in pediatric children over the first 8 hours after dosing on day 1 (least squares mean difference between treatment groups was 1.2; P = .029).,"['Children With the Common Cold', 'pediatric children', 'children aged 6 to 11\xa0years for the temporary relief of nasal congestion due to the common cold']","['23.6%).Pseudoephedrine', 'placebo', 'Placebo', 'pseudoephedrine', 'pseudoephedrine hydrochloride 30-mg tablets', 'Pseudoephedrine']","['instantaneous nasal congestion severity', 'nervousness', 'nasal congestion', 'adverse events, sleepiness ratings, and vital signs', 'insomnia', 'Somnolence', 'efficacy and safety', 'instantaneous nasal congestion severity score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033798', 'cui_str': 'Pseudoephedrine'}, {'cui': 'C2955048', 'cui_str': 'Pseudoephedrine Hydrochloride 30 MG [Sudafed]'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0027769', 'cui_str': 'Nervousness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0518766'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}]",,0.25605,Pseudoephedrine was superior to placebo in reducing instantaneous nasal congestion severity in pediatric children over the first 8 hours after dosing on day 1 (least squares mean difference between treatment groups was 1.2; P = .029).,"[{'ForeName': 'Cathy K', 'Initials': 'CK', 'LastName': 'Gelotte', 'Affiliation': 'Johnson & Johnson Consumer, Inc, Fort Washington, PA, USA.'}, {'ForeName': 'Helmut H', 'Initials': 'HH', 'LastName': 'Albrecht', 'Affiliation': 'Department of Cellular Biology and Pharmacology, Herbert Wertheim College of Medicine, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hynson', 'Affiliation': 'Concentrics Research, Indianapolis, IN, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Gallagher', 'Affiliation': 'Perrigo Company, Allegan, MI, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1472']
663,31267292,The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder.,"Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) that reduces obsessive-compulsive symptoms. There is limited evidence supporting its efficacy for repetitive behaviors (RRBs) in autistic spectrum disorder (ASD). We conducted a randomized controlled trial (RCT) of fluoxetine in 158 individuals with ASD (5-17 years). Following 14 treatment weeks (mean dose 11.8 mg/day), no significant differences were noted on the Children's Yale-Brown Obsessive Compulsive Scale; the proportion of responders was similar (fluoxetine: 36%; placebo: 41%). There were similar rates of AEs (e.g., insomnia, diarrhea, vomiting); high rates of activation were reported in both groups (fluoxetine: 42%; placebo: 45%). Overly cautious dosing/duration may have prevented attainment of a therapeutic level. Results are consistent with other SSRI RCTs treating RRBs in ASD.Trial Registration: clinicaltrials.gov Identifier: NCT00515320.",2020,"There were similar rates of AEs (e.g., insomnia, diarrhea, vomiting); high rates of activation were reported in both groups (fluoxetine: 42%; placebo: 45%).","['Children and Adolescents with Autistic Disorder', 'autistic spectrum disorder (ASD', '158 individuals with ASD (5-17\xa0years']","['fluoxetine', 'placebo', 'Fluoxetine']","[""Children's Yale-Brown Obsessive Compulsive Scale"", 'rates of AEs (e.g., insomnia, diarrhea, vomiting); high rates of activation', 'Repetitive Behaviors']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",158.0,0.165503,"There were similar rates of AEs (e.g., insomnia, diarrhea, vomiting); high rates of activation were reported in both groups (fluoxetine: 42%; placebo: 45%).","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Herscu', 'Affiliation': 'Herscu Laboratory& Consulting, LLC, 356 Middle Street, Amherst, MA, USA.'}, {'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Handen', 'Affiliation': 'School of Medicine, University of Pittsburgh, 1011 Bingham Street, Pittsburgh, PA, 15203, USA. handenbl@upmc.edu.'}, {'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'Nisonger Center - UCEDD,The Ohio State University, McCampbell Hall, 1581 Dodd Drive, Columbus, OH, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Snape', 'Affiliation': 'Neuropharm PLC, London, UK.'}, {'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Bregman', 'Affiliation': 'Center for Autism and Neurodevelopmental Disorders, United Community and Family Services Healthcare, 47 Town Street, Norwich, CT, 06360, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Ginsberg', 'Affiliation': 'Red Oak Psychiatry Associates, 15115 Red Oak Drive #109, Houston, TX, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hendren', 'Affiliation': 'University of California, San Francisco, 401 Parnassus Ave, Box 0984, San Francisco, CA, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolevzon', 'Affiliation': 'Department of Psychiatry, Icahn School of Medicine at Mount Sinai, Seaver Autism Center for Research and Treatment, Mount Sinai School of Medicine, One Gustave L. Levy Place, Box 1230, New York, NY, USA.'}, {'ForeName': 'Raun', 'Initials': 'R', 'LastName': 'Melmed', 'Affiliation': 'Southwest Autism Research and Resource Center, 300 N 18th Street, Phoenix, AZ, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mintz', 'Affiliation': 'The Center for Neurological and Neurodevelopmental Health and the Clinical Research Center of New Jersey, 2050 Voorhees Town Center, Voorhees, NJ, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Minshew', 'Affiliation': ""School of Medicine, University of Pittsburgh, 3811 O'Hara St, Pittsburgh, PA, USA.""}, {'ForeName': 'Linmarie', 'Initials': 'L', 'LastName': 'Sikich', 'Affiliation': 'Duke Center for Autism and Brain Development, Duke University Medical School, 2608 Erwin Rd, Suite 300, Durham, NC, USA.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Attalla', 'Affiliation': 'Institute for Behavioral Medicine, 696 Concord Road SE, Smyrna, GA, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'King', 'Affiliation': 'UCSF Weill Institute for Neurosciences, University of California, San Francisco, 401 Parnassus Ave., Suite LP 358, San Francisco, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Owley', 'Affiliation': 'University of Illinois at Chicago College of Medicine, 1835\xa0W Polk St, Chicago, IL, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Childress', 'Affiliation': 'Center for Psychiatry and Behavioral Medicine, Inc, 7351 Prairie Falcon Road, Suite 160, Las Vegas, NV, 89128, USA.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Chugani', 'Affiliation': 'NYU Langone Comprehensive Epilepsy Center, 223 East 34th Street, New York, NY, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Frazier', 'Affiliation': 'University of Massachusetts Medical Center, 55 Lake Ave., North, Worcester, MA, 01655, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Cartwright', 'Affiliation': 'Spectrum Health Associates, 210 Bellevue Ave, Upper Montclair, NJ, USA.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Murphy', 'Affiliation': 'University of South Florida Rothman Center for Pediatric Neuropsychiatry, 880 6th St South St., Petersburg, FL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of autism and developmental disorders,['10.1007/s10803-019-04120-y']
664,31252090,"Moderators of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Chronic Low Back Pain: A Test of the Limit, Activate, and Enhance Model.","This study examined psychosocial pain treatment moderation in a secondary analysis of a trial that compared cognitive therapy (CT), mindfulness-meditation (MM), and mindfulness-based cognitive therapy (MBCT) for chronic low back pain (CLBP). The Limit, Activate, and Enhance (LA&E) model of moderation provided a framework for testing a priori hypotheses. Adult participants (N = 69) with CLBP completed a pretreatment assessment of hypothesized moderators: pain catastrophizing, brain state as assessed by electroencephalogram, mindful observing, and nonreactivity. Outcomes were pain interference, characteristic pain intensity, physical function, and depression, assessed at pre- and post-treatment. Moderation analyses found significant interaction effects, specifically: 1) higher and lower baseline pain catastrophizing was associated with greater improvement in pain intensity in MM and MBCT, respectively; 2) higher baseline theta power was associated with greater improvement in depression in MBCT and interfered with response to CT; 3) lower baseline nonreactivity was associated with greater improvement in physical function in MM while higher nonreactivity was associated with greater improvement in MBCT. The findings support the possibility that different patients are more or less likely to benefit from various treatments. Theory-driven moderation research has the capacity to inform the development of patient-treatment matching algorithms to optimize outcome. PERSPECTIVE: This study presents preliminary findings from theory-driven tests of the moderators of mindfulness meditation, cognitive therapy, and mindfulness-based cognitive therapy for chronic low back pain. The results of such analyses may inform the understanding of for whom various evidence-based psychosocial pain treatments may engender the most meaningful benefits.",2020,"Moderation analyses found significant interaction effects, specifically: (1) higher and lower baseline pain catastrophizing was associated with greater improvement in pain intensity in MM and MBCT, respectively; (2) higher baseline theta power was associated with greater improvement in depression in MBCT and interfered with response to CT; (3) lower baseline non-reactivity was associated with greater improvement in physical function in MM while higher non-reactivity was associated with greater improvement in MBCT.","['chronic low back pain (CLBP', 'Adult participants (N=69) with CLBP completed a pre-treatment assessment of hypothesized moderators: pain catastrophizing, brain state as assessed by electroencephalogram, mindful observing, and non-reactivity', 'chronic low back pain']","['cognitive therapy (CT), mindfulness-meditation (MM), and mindfulness-based cognitive therapy (MBCT', 'mindfulness meditation, cognitive therapy and mindfulness-based cognitive therapy', 'mindfulness meditation, cognitive therapy, and mindfulness-based cognitive therapy']","['physical function', 'MBCT', 'pain interference, characteristic pain intensity, physical function, and depression, assessed at pre- and post-treatment', 'depression in MBCT', 'pain intensity']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",69.0,0.0330779,"Moderation analyses found significant interaction effects, specifically: (1) higher and lower baseline pain catastrophizing was associated with greater improvement in pain intensity in MM and MBCT, respectively; (2) higher baseline theta power was associated with greater improvement in depression in MBCT and interfered with response to CT; (3) lower baseline non-reactivity was associated with greater improvement in physical function in MM while higher non-reactivity was associated with greater improvement in MBCT.","[{'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Day', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Queensland, Australia. Electronic address: m.day@uq.edu.au.'}, {'ForeName': 'Beverly E', 'Initials': 'BE', 'LastName': 'Thorn', 'Affiliation': 'Department of Psychology, University of Alabama, Tuscaloosa, Alabama.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Ehde', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Burns', 'Affiliation': 'Department of Behavioral Sciences, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Barnier', 'Affiliation': 'Department of Cognitive Science, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jason B', 'Initials': 'JB', 'LastName': 'Mattingley', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Queensland, Australia; Queensland Brain Institute, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Matthews', 'Affiliation': 'School of Psychology, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Jensen', 'Affiliation': 'Department of Rehabilitation Medicine, University of Washington, Seattle, Washington.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.06.006']
665,31794952,"Use of the mixed reality tool ""VSI Patient Education"" for more comprehensible and imaginable patient educations before epilepsy surgery and stereotactic implantation of DBS or stereo-EEG electrodes.","PURPOSE


It is unknown which patient education strategy before epilepsy surgery or stereotactic electrode implantation is best for patients. This prospective and randomized clinical study investigates whether the use of the mixed reality tool ""VSI Patient Education"" (VSI PE) running on HoloLens® glasses is superior to the use of a rubber brain model as a 3-dimensional tool for patient education before epilepsy surgery and stereotactic electrode implantation.
MATERIAL AND METHODS


17 patients with indication for epilepsy surgery or stereotactic electrode implantation were included in the study and randomized into two groups. All patients were informed with both comparative tools VSI PE (apoQlar®) and a rubber brain model (3B Scientific®) in a chronological order depending on group assignment. Afterwards, the patient and, if present, a relative (12) each filled out a questionnaire. For statistical analysis, Wilcoxon rank-sum tests were performed.
RESULTS


Patients found their patient education highly significantly more comprehensible (p = 0.001**, r = 0.84) and almost significantly more imaginable (p=0.020, r = 0.57), when their doctor used VSI PE compared to the rubber brain model. The patients felt significantly less anxious as a result of VSI PE (p = 0.008*, r = 0.64). Highly significantly more patients chose VSI PE as the preferred patient education tool (p < 0.001**, r = 0.91), and almost significantly more patients decided VSI PE to be the future standard tool (p = 0.020, r = 0.56). Significantly more relatives chose VSI PE as the preferred patient education tool (p = 0.004*, r = 0.83), and significantly more relatives decided VSI PE to be the future standard tool (p = 0.002*, r = 0.91).
CONCLUSION


VSI Patient Education is a promising new mixed reality tool for informing patients before epileptic surgery or stereotactic electrode implantation in order to enhance comprehension and imagination and reduce fear and worries. It might strengthen patient commitment and have a positive influence on patients' decisions in favor of medically indicated surgical operations.",2020,"RESULTS


Patients found their patient education highly significantly more comprehensible (p = 0.001",['17 patients with indication for epilepsy surgery or'],"['DBS or stereo-EEG electrodes', 'stereotactic electrode implantation', 'mixed reality tool ""VSI Patient Education"" (VSI PE) running', 'comparative tools VSI PE (apoQlar®) and a rubber brain model (3B Scientific®']","['VSI PE', 'comprehensible']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C4523971', 'cui_str': 'Epilepsy surgery'}]","[{'cui': 'C0180635', 'cui_str': 'EEG electrode'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic (qualifier value)'}, {'cui': 'C0013812', 'cui_str': 'Electrode, device (physical object)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0035918', 'cui_str': 'Natural Rubber'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",[],17.0,0.0372503,"RESULTS


Patients found their patient education highly significantly more comprehensible (p = 0.001","[{'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'House', 'Affiliation': 'Hamburg Epilepsy Center, Protestant Hospital Alsterdorf, Department of Neurology and Epileptology, Hamburg, Germany. Electronic address: p.house@eka.alsterdorf.de.'}, {'ForeName': 'Sirko', 'Initials': 'S', 'LastName': 'Pelzl', 'Affiliation': 'apoQlar GmbH, Hamburg, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Furrer', 'Affiliation': 'apoQlar GmbH, Hamburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lanz', 'Affiliation': 'Hamburg Epilepsy Center, Protestant Hospital Alsterdorf, Department of Neurology and Epileptology, Hamburg, Germany.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Simova', 'Affiliation': 'Hamburg Epilepsy Center, Protestant Hospital Alsterdorf, Department of Neurology and Epileptology, Hamburg, Germany.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Voges', 'Affiliation': 'Hamburg Epilepsy Center, Protestant Hospital Alsterdorf, Department of Neurology and Epileptology, Hamburg, Germany.'}, {'ForeName': 'Stefan R G', 'Initials': 'SRG', 'LastName': 'Stodieck', 'Affiliation': 'Hamburg Epilepsy Center, Protestant Hospital Alsterdorf, Department of Neurology and Epileptology, Hamburg, Germany.'}, {'ForeName': 'Katja E', 'Initials': 'KE', 'LastName': 'Brückner', 'Affiliation': 'Hamburg Epilepsy Center, Protestant Hospital Alsterdorf, Department of Neurology and Epileptology, Hamburg, Germany.'}]",Epilepsy research,['10.1016/j.eplepsyres.2019.106247']
666,31246370,"Clinical efficacy of a combined acceptance and commitment therapy, dialectical behavioural therapy, and functional analytic psychotherapy intervention in patients with borderline personality disorder.","OBJECTIVE


Borderline personality disorder (BPD) consists of a persistent pattern of instability in affective regulation, impulse control, interpersonal relationships, and self-image. Although certain forms of psychotherapy are effective, their effects are small to moderate. One of the strategies that have been proposed to improve interventions involves integrating the therapeutic elements of different psychotherapy modalities from a contextual behavioural perspective (ACT, DBT, and FAP).
METHODS


Patients (n = 65) attending the BPD Clinic of the Instituto Nacional de Psiquiatría Ramón de la Fuente Muñíz in Mexico City who agreed to participate in the study were assigned to an ACT group (n = 22), a DBT group (n = 20), or a combined ACT + DBT + FAP therapy group (n = 23). Patients were assessed at baseline and after therapeutic trial on measures of BPD symptom severity, emotion dysregulation, experiential avoidance, attachment, control over experiences, and awareness of stimuli.
RESULTS


ANOVA analyses showed no differences between the three therapeutic groups in baseline measures. Results of the MANOVA model showed significant differences in most dependent measures over time but not between therapeutic groups.
CONCLUSIONS


Three modalities of brief, contextual behavioural therapy proved to be useful in decreasing BPD symptom severity and emotional dysregulation, as well as negative interpersonal attachment. These changes were related to the reduction of experiential avoidance and the acquisition of mindfulness skills in all treatment groups, which may explain why no differences between the three different intervention modalities were observed.
PRACTITIONER POINTS


Brief adaptations of acceptance and commitment therapy and dialectical behavioural therapy are effective interventions for BPD patients, in combined or isolated modalities, and with or without the inclusion of functional analytic psychotherapy. The reduction of experiential avoidance and the acquisition of mindfulness skills are related with the diminution of BPD symptoms severity, including emotional dysregulation and negative interpersonal attachment.",2020,"These changes were related to the reduction of experiential avoidance and the acquisition of mindfulness skills in all treatment groups, which may explain why no differences between the three different intervention modalities were observed.
","['BPD patients', 'Patients (n\xa0', '65) attending the BPD Clinic of the Instituto Nacional de Psiquiatría Ramón de la Fuente Muñíz in Mexico City who agreed to participate in the study were assigned to an', 'patients with borderline personality disorder']","['DBT', 'ACT', 'combined ACT', '\xa0DBT\xa0+\xa0FAP therapy', 'combined acceptance and commitment therapy, dialectical behavioural therapy, and functional analytic psychotherapy intervention', 'acceptance and commitment therapy and dialectical behavioural therapy', 'contextual behavioural therapy']","['BPD symptom severity and emotional dysregulation', 'BPD symptoms severity, including emotional dysregulation and negative interpersonal attachment', 'experiential avoidance and the acquisition of mindfulness skills', 'BPD symptom severity, emotion dysregulation, experiential avoidance, attachment, control over experiences, and awareness of stimuli']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}]",,0.0178641,"These changes were related to the reduction of experiential avoidance and the acquisition of mindfulness skills in all treatment groups, which may explain why no differences between the three different intervention modalities were observed.
","[{'ForeName': 'Michel A', 'Initials': 'MA', 'LastName': 'Reyes-Ortega', 'Affiliation': 'Academic Coordination Department, Contextual Behavioral Science and Therapy Institute, Mexico City, Mexico.'}, {'ForeName': 'Edgar M', 'Initials': 'EM', 'LastName': 'Miranda', 'Affiliation': 'Clinic of Borderline Personality Disorder, Directorate of Clinical Services, Ramón de la Fuente Muñiz National Institute of Psychiatry, Mexico City, Mexico.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fresán', 'Affiliation': 'Laboratory of Clinical Epidemiology, Sub-directorate of Clinical Research, Ramón de la Fuente Muñiz National Institute of Psychiatry, Mexico City, Mexico.'}, {'ForeName': 'Angélica N', 'Initials': 'AN', 'LastName': 'Vargas', 'Affiliation': 'Coordination Department of Clinical Services, Contextual Behavioral Science and Therapy Institute, Mexico City, Mexico.'}, {'ForeName': 'Sandra C', 'Initials': 'SC', 'LastName': 'Barragán', 'Affiliation': 'Grantholder of the National Council for Science and Technology (CONACYT) for a project of the Ramón de la Fuente Muñiz National Institute of Psychiatry, Mexico City, Mexico.'}, {'ForeName': 'Rebeca', 'Initials': 'R', 'LastName': 'Robles García', 'Affiliation': 'Center of Research on Global Mental Health, Department of Innovation and Global Health, Directorate of Epidemiological and Psychosocial Research, Ramón de la Fuente Muñiz National Institute of Psychiatry, Mexico City, Mexico.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Arango', 'Affiliation': 'Clinic of Borderline Personality Disorder, Directorate of Clinical Services, Ramón de la Fuente Muñiz National Institute of Psychiatry, Mexico City, Mexico.'}]",Psychology and psychotherapy,['10.1111/papt.12240']
667,31797578,"Filgotinib, a JAK1 Inhibitor, Has No Effect on QT Interval in Healthy Subjects.","Filgotinib, a selective inhibitor of Janus kinase 1, is being developed for the treatment of chronic inflammatory diseases. Electrocardiograms evaluated the effect of filgotinib on the corrected QT (QTc) interval in 52 healthy subjects who received each of 4 treatments: filgotinib 200 mg (therapeutic dose), 450 mg (supratherapeutic dose), and placebo, each administered once daily for 7 days, and a single dose of moxifloxacin 400 mg (positive control). Plasma samples were collected for pharmacokinetic analysis. The QTc interval was calculated using Fridericia's correction factor (QTcF) or an individual correction factor (QTcI). The relationship between plasma concentrations of filgotinib and its major metabolite and time-matched, baseline-adjusted, placebo-corrected QTc (ΔΔQTc) was evaluated. Filgotinib did not prolong QTcF or QTcI and using an appropriate mixed-effect model, the upper limit of the 2-sided 90% confidence interval for ΔΔQTc for each filgotinib dose (200 and 450 mg) remained below 10 milliseconds at all postdose time points. There were no clinically relevant relationships between QTc interval and plasma concentrations of filgotinib or its major metabolite. Filgotinib, administered at 200 or 450 mg, was generally well tolerated. Results of this thorough QT study demonstrate that filgotinib and its major metabolite are not associated with QTc interval prolongation.",2020,"Electrocardiograms evaluated the effect of filgotinib on the corrected QT (QTc) interval in 52 healthy subjects who received each of 4 treatments: filgotinib 200 mg (therapeutic dose), 450 mg (supratherapeutic dose), and placebo, each administered once daily for 7 days, and a single dose of moxifloxacin 400 mg (positive control).","['Healthy Subjects', '52 healthy subjects who received each of 4 treatments']","['moxifloxacin 400\xa0mg (positive control', 'filgotinib 200\xa0mg (therapeutic dose), 450\xa0mg (supratherapeutic dose), and placebo']","['tolerated', 'QT Interval', 'QTc interval', 'QTcF or QTcI', 'QTc interval and plasma concentrations of filgotinib or its major metabolite']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1592286', 'cui_str': 'moxifloxacin 400 MG [Avelox]'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4310256', 'cui_str': 'filgotinib'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4310256', 'cui_str': 'filgotinib'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",52.0,0.0844319,"Electrocardiograms evaluated the effect of filgotinib on the corrected QT (QTc) interval in 52 healthy subjects who received each of 4 treatments: filgotinib 200 mg (therapeutic dose), 450 mg (supratherapeutic dose), and placebo, each administered once daily for 7 days, and a single dose of moxifloxacin 400 mg (positive control).","[{'ForeName': 'Kacey', 'Initials': 'K', 'LastName': 'Anderson', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xin', 'Affiliation': 'Horizon Pharma, South San Francisco, California, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Chohee', 'Initials': 'C', 'LastName': 'Yun', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Kwan', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Qin', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Namour', 'Affiliation': 'Galapagos SASU, Romainville, France.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Kearney', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Mathias', 'Affiliation': 'Gilead Sciences, Inc, Foster City, California, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.755']
668,31243790,"First-in-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of an Oral Formulation of DS-1040, an Inhibitor of the Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor, in Healthy Subjects.","DS-1040, a low-molecular-weight imidazole derivative, inhibits the enzymatic activity of thrombin-activatable fibrinolysis inhibitor (TAFIa), enhancing endogenous tissue plasminogen activator-triggered fibrinolysis. This first-in-human, randomized, placebo-controlled, phase 1 study evaluated the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of an oral formulation of DS-1040. Healthy adults (aged 20-45 years; N = 56) were randomized 3:1 to receive DS-1040 orally administered as single ascending doses (50, 100, 200, or 400 mg) or placebo, or DS-1040 multiple ascending doses (100 mg once daily, 200 mg once daily, or 150 mg twice daily) or placebo for 14 days. Safety, PK, and PD parameters were assessed. All doses of DS-1040 were well tolerated; no serious/severe adverse events (AEs) or discontinuations due to AEs occurred. DS-1040 had no effect on coagulation parameters, and no treatment-related trends in the bleeding time were observed. DS-1040 exposure (peak concentration and area under the concentration-time curve) increased in a dose-proportional manner across the single-dose range. With multiple doses, steady state was achieved by day 7 with minimal accumulation (mean accumulation ratio 1.15-1.25), and the PK was time-independent. After 72 hours, approximately 10% of the DS-1040 400-mg single dose was recovered in urine as intact parent drug. The mean terminal half-life ranged from 17.2 to 24.9 hours, which was similar to previous intravenous administration data. Dose-dependent inhibition of total TAFIa activity was observed following single and multiple doses of oral DS-1040. The safety and PK/PD profiles of oral DS-1040 in healthy subjects support further clinical development.",2019,All doses of DS-1040 were well tolerated; no serious/severe adverse events (AEs) or discontinuations due to AEs occurred.,"['Healthy Subjects', 'Healthy adults (aged 20-45 years; N = 56', 'healthy subjects']","['placebo, or DS-1040 multiple ascending doses', 'placebo', 'DS-1040']","['coagulation parameters', 'Safety, PK, and PD parameters', 'Safety, Pharmacokinetics, and Pharmacodynamics', 'total TAFIa activity', 'tolerated; no serious/severe adverse events', 'DS-1040 exposure (peak concentration and area under the concentration-time curve', 'safety, pharmacokinetics (PK), and pharmacodynamics (PD', 'bleeding time']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205385', 'cui_str': 'Ascending (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0005729', 'cui_str': 'Bleeding Time'}]",56.0,0.0991134,All doses of DS-1040 were well tolerated; no serious/severe adverse events (AEs) or discontinuations due to AEs occurred.,"[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Tharin', 'Initials': 'T', 'LastName': 'Limsakun', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Ophelia', 'Initials': 'O', 'LastName': 'Yin', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Vance', 'Initials': 'V', 'LastName': 'Warren', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Zamora', 'Affiliation': 'Worldwide Clinical Trials, San Antonio, TX, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Atiee', 'Affiliation': 'Worldwide Clinical Trials, San Antonio, TX, USA.'}, {'ForeName': 'Jarema', 'Initials': 'J', 'LastName': 'Kochan', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pav', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Kobayashi', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Vashi', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Dishy', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, NJ, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1474']
669,30949987,"Pentoxifylline, progression of chronic kidney disease (CKD) and cardiovascular mortality: long-term follow-up of a randomized clinical trial.","BACKGROUND


Pentoxifylline could reduce proteinuria and slow renal disease progression. We previously conducted a single-blind, randomized, controlled trial that showed that pentoxifylline decreases inflammatory markers and stabilizes renal function.
SETTING AND PARTICIPANTS


91 participants (46 in the pentoxifylline group and 45 in the control group) followed up for 7 additional years.
STUDY DESIGN


Post hoc analysis of a long-term follow-up after completion of the 12-months trial.
INTERVENTION


Pentoxifylline treatment (400 mg/twice a day) or standard treatment.
OUTCOME


Renal event (defined as starting dialysis therapy and/or doubling serum creatinine and/or ≥ 50% decrease in estimated glomerular filtration rate) and cardiovascular mortality.
RESULTS


During follow-up, a renal event was recorded in 24 patients from control group (13 initiated dialysis therapy and serum creatinine doubled in 11) and 11 patients from PTF group (7 initiated dialysis and serum creatinine doubled in 4) (log Rank: 5.822, p = 0.016). The possible protector effect of PTF was more significant in albuminuric patients and was independently of diabetes mellitus presence. Treatment with PTF reduced the renal events by 35% compared to the control group in a Cox model adjusted for diabetes mellitus, albuminuria and basal renal function (HR 0.65 (0.45-0.94), p = 0.022). Cardiovascular mortality was significantly reduced in PTF treatment (2 patients vs. 10 in control group) (log Rank 5.0977, p = 0.024). PTF treatment reduced cardiovascular mortality in 55% adjusted for diabetes mellitus and age (HR 0.45 (0.21-0.98), p = 0.044) (Table 3).
LIMITATIONS


Small sample size, single center, not double blind and post hoc follow-up analysis.
CONCLUSIONS


Long-term treatment with pentoxifylline may slow the rate of progression of kidney disease and reduce cardiovascular risk.",2019,"Treatment with PTF reduced the renal events by 35% compared to the control group in a Cox model adjusted for diabetes mellitus, albuminuria and basal renal function (HR 0.65 (0.45-0.94), p = 0.022).","['group and 45 in the control group) followed up for 7 additional years', '91 participants (46 in the']","['Pentoxifylline treatment (400\xa0mg/twice a day) or standard treatment', 'PTF', 'pentoxifylline', 'Pentoxifylline']","['diabetes mellitus, albuminuria and basal renal function', 'renal events', 'chronic kidney disease (CKD) and cardiovascular mortality', 'rate of progression of kidney disease and reduce cardiovascular risk', 'inflammatory markers and stabilizes renal function', 'renal event', 'Renal event (defined as starting dialysis therapy and/or doubling serum creatinine', 'estimated glomerular filtration rate) and cardiovascular mortality', 'proteinuria and slow renal disease progression', 'Cardiovascular mortality', 'cardiovascular mortality']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C3811844'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}]",24.0,0.0974305,"Treatment with PTF reduced the renal events by 35% compared to the control group in a Cox model adjusted for diabetes mellitus, albuminuria and basal renal function (HR 0.65 (0.45-0.94), p = 0.022).","[{'ForeName': 'Alejandra Muñoz', 'Initials': 'AM', 'LastName': 'de Morales', 'Affiliation': 'Nephrology Department, Hospital General Universitario Gregorio Marañón, C/Dr Esquerdo 46, 28007, Madrid, Spain.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Goicoechea', 'Affiliation': 'Nephrology Department, Hospital General Universitario Gregorio Marañón, C/Dr Esquerdo 46, 28007, Madrid, Spain. marian.goicoechea@gmail.com.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Verde', 'Affiliation': 'Nephrology Department, Hospital General Universitario Gregorio Marañón, C/Dr Esquerdo 46, 28007, Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Carbayo', 'Affiliation': 'Nephrology Department, Hospital General Universitario Gregorio Marañón, C/Dr Esquerdo 46, 28007, Madrid, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Barbieri', 'Affiliation': 'Nephrology Department, Hospital General Universitario Gregorio Marañón, C/Dr Esquerdo 46, 28007, Madrid, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Delgado', 'Affiliation': 'Nephrology Department, Hospital General Universitario Gregorio Marañón, C/Dr Esquerdo 46, 28007, Madrid, Spain.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Verdalles', 'Affiliation': 'Nephrology Department, Hospital General Universitario Gregorio Marañón, C/Dr Esquerdo 46, 28007, Madrid, Spain.'}, {'ForeName': 'Ana Perez', 'Initials': 'AP', 'LastName': 'de Jose', 'Affiliation': 'Nephrology Department, Hospital General Universitario Gregorio Marañón, C/Dr Esquerdo 46, 28007, Madrid, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Luño', 'Affiliation': 'Nephrology Department, Hospital General Universitario Gregorio Marañón, C/Dr Esquerdo 46, 28007, Madrid, Spain.'}]",Journal of nephrology,['10.1007/s40620-019-00607-0']
670,31719087,Randomised clinical trial of an emergency department-based peer recovery support intervention to increase treatment uptake and reduce recurrent overdose among individuals at high risk for opioid overdose: study protocol for the navigator trial.,"INTRODUCTION


Effective approaches to increase engagement in treatment for opioid use disorder (OUD) and reduce the risk of recurrent overdose and death following emergency department (ED) presentation for opioid overdose remain unknown. As such, we aim to compare the effectiveness of behavioural interventions delivered in the ED by certified peer recovery support specialists relative to those delivered by licensed clinical social workers (LCSWs) in promoting OUD treatment uptake and reducing recurrent ED visits for opioid overdose.
METHODS AND ANALYSIS


Adult ED patients who are at high risk for opioid overdose (ie, are being treated for an opioid overdose or identified by the treating physician as having OUD) (n=650) will be recruited from two EDs in a single healthcare system in Providence, Rhode Island into a two-arm randomised trial with 18 months of follow-up postrandomisation. Eligible participants will be randomly assigned (1:1) in the ED to receive a behavioural intervention from a certified peer recovery support specialist or a behavioural intervention from an LCSW. The primary outcomes are engagement in formal OUD treatment within 30 days of the initial ED visit and recurrent ED visits for opioid overdose within 18 months of the initial ED visit, as measured through statewide administrative records.
ETHICS AND DISSEMINATION


This protocol was approved by the Rhode Island Hospital institutional review board (Approval Number: 212418). Data will be presented at national and international conferences and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03684681.",2019,"The primary outcomes are engagement in formal OUD treatment within 30 days of the initial ED visit and recurrent ED visits for opioid overdose within 18 months of the initial ED visit, as measured through statewide administrative records.
","['individuals at high risk for opioid overdose', 'Adult ED patients who are at high risk for opioid overdose (ie, are being treated for an opioid overdose or identified by the treating physician as having OUD', 'Eligible participants']","['behavioural intervention from a certified peer recovery support specialist or a behavioural intervention from an LCSW', 'emergency department-based peer recovery support intervention', 'behavioural interventions']","['engagement in formal OUD treatment within 30 days of the initial ED visit and recurrent ED visits for opioid overdose within 18 months of the initial ED visit, as measured through statewide administrative records']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0029944', 'cui_str': 'Drug Overdose'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1301664', 'cui_str': 'Administrative record'}]",,0.120482,"The primary outcomes are engagement in formal OUD treatment within 30 days of the initial ED visit and recurrent ED visits for opioid overdose within 18 months of the initial ED visit, as measured through statewide administrative records.
","[{'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Goedel', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Brandon D L', 'Initials': 'BDL', 'LastName': 'Marshall', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Samuels', 'Affiliation': 'Department of Emergency Medicine, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Brinkman', 'Affiliation': 'Department of Emergency Medicine, Rhode Island Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Dettor', 'Affiliation': 'Anchor Recovery Community Center, Pawtucket, Rhode Island, USA.'}, {'ForeName': 'Kirsten J', 'Initials': 'KJ', 'LastName': 'Langdon', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'Mahoney', 'Affiliation': 'Rhode Island Department of Behavioral Healthcare Developmental Disabilities and Hospitals, Cranston, Rhode Island, USA.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Merchant', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Nizami', 'Affiliation': 'Department of Emergency Medicine, Rhode Island Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': ""O'Toole"", 'Affiliation': 'Anchor Recovery Community Center, Pawtucket, Rhode Island, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Ramsey', 'Affiliation': 'Department of Psychiatry and Human Behavior, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Jesse L', 'Initials': 'JL', 'LastName': 'Yedinak', 'Affiliation': 'Department of Epidemiology, Brown University School of Public Health, Providence, Rhode Island, USA.'}, {'ForeName': 'Francesca L', 'Initials': 'FL', 'LastName': 'Beaudoin', 'Affiliation': 'Department of Emergency Medicine, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA Francesca_Beaudoin@brown.edu.'}]",BMJ open,['10.1136/bmjopen-2019-032052']
671,31785587,Kinetics of oxytocin effects on amygdala and striatal reactivity vary between women and men.,"Accumulating evidence suggests that intranasal oxytocin (OXT; 24 IU) reduces amygdala responses to fear-related stimuli in men, while exerting inverse effects in women. However, OXT enhances activity of the brain reward system in both sexes. Importantly, a crucial and still open question is whether there are sex-specific dose-response relationships for the amygdala and striatal regions. To address this question, a total of 90 healthy women participated in a double-blind, placebo-controlled crossover functional magnetic resonance imaging (fMRI) study and the results were compared with our previous findings from men. Participants were randomly assigned to three doses of OXT (6 IU, 12 IU, and 24 IU) and completed an emotional face recognition task including fearful and happy faces of varying emotional intensities. Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women. While treatment effects on amygdala reactivity were evident at each given dose, the OXT effect on striatal responses to social stimuli was more pronounced with higher doses, but this dose-dependent effect did not survive correction for multiple comparisons. Importantly, OXT effects on amygdala and striatal activation significantly differed between sexes and striatal baseline sexual-dimorphic response patterns were diminished after administration of OXT. Our findings suggest that OXT increases the salience of social signals by strengthening the sensitivity for these signals in the amygdala and in the striatum in women, while OXT may primarily induce anxiolysis by reducing amygdala responses in men.",2020,"Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women.","['90 healthy women participated in a double-blind', 'women and men']","['OXT', 'placebo-controlled crossover functional magnetic resonance imaging (fMRI', 'oxytocin', 'intranasal oxytocin (OXT', 'placebo', 'emotional face recognition task including fearful and happy faces of varying emotional intensities']","['amygdala reactivity', 'amygdala and striatal reactivity', 'OXT effects on amygdala and striatal activation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",90.0,0.234159,"Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women.","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Lieberz', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany. Dirk-Scheele@gmx.de.'}, {'ForeName': 'Franny B', 'Initials': 'FB', 'LastName': 'Spengler', 'Affiliation': 'Institute for Psychology, University of Freiburg, 79104, Freiburg, Germany.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Matheisen', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Lìa', 'Initials': 'L', 'LastName': 'Schneider', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Stoffel-Wagner', 'Affiliation': 'Institute of Clinical Chemistry and Clinical Pharmacology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kinfe', 'Affiliation': 'Department of Neurosurgery, Division of Functional Neurosurgery and Stereotaxy, Friedrich-Alexander University (FAU) Erlangen-Nürnberg, 91054, Erlangen, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0582-6']
672,31232097,Mind-body interactive qigong improves physical and mental aspects of quality of life in inpatients with stroke: A randomized control study.,"BACKGROUND


Stroke, a medical condition that causes physical disability and mental health problems, impacts negatively on quality of life. Post-stroke rehabilitation is critical to restoring quality of life in these patients.
OBJECTIVES


This study was designed to evaluate the effect of a mind-body interactive qigong intervention on the physical and mental aspects of quality of life, considering bio-physiological and mental covariates in subacute stroke inpatients.
METHODS


A randomized controlled trial with repeated measures design was used. A total of 68 participants were recruited from the medical and rehabilitation wards at a teaching hospital in northern Taiwan and then randomly assigned either to the Chan-Chuang qigong group, which received standard care plus a 10-day mind-body interactive exercise program, or to the control group, which received standard care only. Data were collected using the National Institutes of Health Stroke Scale, Hospital Anxiety and Depression Scale, Short Form-12, stroke-related neurologic deficit, muscular strength, heart rate variability and fatigue at three time points: pre-intervention, halfway through the intervention (day 5) and on the final day of the intervention (day 10).
RESULTS


The results of the mixed-effect model analysis showed that the qigong group had a significantly higher quality of life score at day 10 ( p <0.05) than the control group. Among the covariates, neurologic deficit ( p =0.04), muscle strength ( p =0.04), low frequency to high frequency ratio ( p =0.02) and anxiety ( p =0.04) were significantly associated with changes in quality of life. Conversely, heart rate, heart rate variability (standard deviation of normal-to-normal intervals, low frequency and high frequency), fatigue and depression were not significantly associated with change in quality of life ( p  >0.05).
CONCLUSIONS


This study supports the potential benefits of a 10-day mind-body interactive exercise (Chan-Chuang qigong) program for subacute stroke inpatients and provides information that may be useful in planning adjunctive rehabilitative care for stroke inpatients.",2019,The results of the mixed-effect model analysis showed that the qigong group had a significantly higher quality of life score at day 10 ( p <0.05) than the control group.,"['stroke inpatients', '68 participants were recruited from the medical and rehabilitation wards at a teaching hospital in northern Taiwan', 'inpatients with stroke', 'subacute stroke inpatients']","['mind-body interactive qigong intervention', 'Mind-body interactive qigong', 'Chan-Chuang qigong group, which received standard care plus a 10-day mind-body interactive exercise program, or to the control group, which received standard care only', '10-day mind-body interactive exercise (Chan-Chuang qigong) program']","['quality of life score', 'quality of life, considering bio-physiological and mental covariates', 'physical and mental aspects of quality of life', 'muscle strength', 'quality of life', 'Health Stroke Scale, Hospital Anxiety and Depression Scale, Short Form-12, stroke-related neurologic deficit, muscular strength, heart rate variability and fatigue', 'neurologic deficit', 'heart rate, heart rate variability (standard deviation of normal-to-normal intervals, low frequency and high frequency), fatigue and depression', 'anxiety']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}]","[{'cui': 'C0282077', 'cui_str': ""Ch'i Kung""}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1135599', 'cui_str': 'mental aspects'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",68.0,0.0727694,The results of the mixed-effect model analysis showed that the qigong group had a significantly higher quality of life score at day 10 ( p <0.05) than the control group.,"[{'ForeName': 'Ching-Hsiang', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Hsinchu Cathay General Hospital, Hsinchu, Taiwan.'}, {'ForeName': 'Kuo-Sheng', 'Initials': 'KS', 'LastName': 'Hung', 'Affiliation': 'Graduate Institute of Injury Prevention and Control, and Department of Neurosurgery, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chu', 'Initials': 'YC', 'LastName': 'Chung', 'Affiliation': 'Department of Nursing, Yuanpei University of Medical Technology, Hsinchu, Taiwan.'}, {'ForeName': 'Mei-Ling', 'Initials': 'ML', 'LastName': 'Yeh', 'Affiliation': 'Department of Nursing, National Taipei University of Nursing & Health Sciences, Taipei, Taiwan.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515119860232']
673,31220920,Evaluating ACT Processes in Relation to Outcome in Self-Help Treatment for Anxiety-Related Problems.,"Evaluating how, for whom, and under what conditions psychosocial treatments work is an important component of anxiety disorder treatment development. Yet, research regarding mediators and moderators of self-help interventions is sparse. The current project is a secondary analysis of mediators, moderators, and correlates of outcome of a randomized wait-list-controlled trial assessing acceptance and commitment therapy (ACT) self-help bibliotherapy for anxiety and related problems. Participants ( n  = 503) were randomized to an immediate workbook ( n  = 256) or wait-list condition ( n  = 247). Nonparametric bootstrapped mediation analyses showed that pre-post positive changes in ACT treatment processes accounted for the relation between treatment and pre-post improvement on the primary outcomes of anxiety symptoms, depressive symptoms, and quality of life. Results indicated no baseline variables were significant moderators. Finally, hierarchical regression analyses indicated that the degree of improvement for each primary outcome was positively correlated with the degree to which participants reported applying the workbook material to their day-to-day life, over and above how much of the book they reported reading. This study provided support for the ACT model of change in a self-help context and highlighted the importance of actively applying self-help material, addressing theoretical and practical questions about how and why ACT self-help works.",2020,Participants ( n  = 503) were randomized to an immediate workbook ( n  = 256) or wait-list condition ( n  = 247).,['Participants ( n  = 503'],['immediate workbook ( n  = 256) or wait-list condition'],"['anxiety symptoms, depressive symptoms, and quality of life']",[],"[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034380'}]",503.0,0.0710193,Participants ( n  = 503) were randomized to an immediate workbook ( n  = 256) or wait-list condition ( n  = 247).,"[{'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Ritzert', 'Affiliation': 'Longwood University, Farmville, VA, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Berghoff', 'Affiliation': 'University of South Dakota, Vermillion, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Tifft', 'Affiliation': 'University at Albany, State University of New York, Albany, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Forsyth', 'Affiliation': 'University at Albany, State University of New York, Albany, USA.'}]",Behavior modification,['10.1177/0145445519855616']
674,30824296,A 16-yr Follow-up of the European Randomized study of Screening for Prostate Cancer.,"BACKGROUND


The European Randomized study of Screening for Prostate Cancer (ERSPC) has previously demonstrated that prostate-specific antigen (PSA) screening decreases prostate cancer (PCa) mortality.
OBJECTIVE


To determine whether PSA screening decreases PCa mortality for up to 16yr and to assess results following adjustment for nonparticipation and the number of screening rounds attended.
DESIGN, SETTING, AND PARTICIPANTS


This multicentre population-based randomised screening trial was conducted in eight European countries. Report includes 182160 men, followed up until 2014 (maximum of 16yr), with a predefined core age group of 162389 men (55-69yr), selected from population registry.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The outcome was PCa mortality, also assessed with adjustment for nonparticipation and the number of screening rounds attended.
RESULTS AND LIMITATIONS


The rate ratio of PCa mortality was 0.80 (95% confidence interval [CI] 0.72-0.89, p<0.001) at 16yr. The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr. The number of men needed to be invited for screening to prevent one PCa death was 570 at 16yr compared with 742 at 13yr. The number needed to diagnose was reduced to 18 from 26 at 13yr. Men with PCa detected during the first round had a higher prevalence of PSA >20ng/ml (9.9% compared with 4.1% in the second round, p<0.001) and higher PCa mortality (hazard ratio=1.86, p<0.001) than those detected subsequently.
CONCLUSIONS


Findings corroborate earlier results that PSA screening significantly reduces PCa mortality, showing larger absolute benefit with longer follow-up and a reduction in excess incidence. Repeated screening may be important to reduce PCa mortality on a population level.
PATIENT SUMMARY


In this report, we looked at the outcomes from prostate cancer in a large European population. We found that repeated screening reduces the risk of dying from prostate cancer.",2019,The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr.,"['eight European countries', '182160 men, followed up until 2014 (maximum of 16yr), with a predefined core age group of 162389 men (55-69yr), selected from population registry']",['PSA screening'],"['PCa mortality', 'rate ratio of PCa mortality', 'absolute PCa mortality', 'risk of dying from prostate cancer', 'PCa death', 'PCa mortality, also assessed with adjustment for nonparticipation and the number of screening rounds attended', 'number needed to diagnose']","[{'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",,0.339695,The difference in absolute PCa mortality increased from 0.14% at 13yr to 0.18% at 16yr.,"[{'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hugosson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden. Electronic address: jonas.hugosson@gu.se.'}, {'ForeName': 'Monique J', 'Initials': 'MJ', 'LastName': 'Roobol', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Månsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'University of Tampere, Faculty of Medicine and Life Sciences, Tampere, Finland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Zappa', 'Affiliation': 'ISPRO, Oncological network, Prevention, and Research Institute, Florence, Italy.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Nelen', 'Affiliation': 'Provinciaal Instituut voor Hygiëne, Antwerp, Belgium.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kwiatkowski', 'Affiliation': 'Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland; Department of Urology, Academic Hospital Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Lujan', 'Affiliation': 'Urology Department, Hospital Infanta Cristina, Parla, Madrid, Spain.'}, {'ForeName': 'Sigrid V', 'Initials': 'SV', 'LastName': 'Carlsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden; Departments of Surgery (Urology Service) and Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Kirsi M', 'Initials': 'KM', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Lilja', 'Affiliation': 'Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK; Department of Translational Medicine, Lund University, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Denis', 'Affiliation': 'Europa Uomo, Oncology Centre Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Recker', 'Affiliation': 'Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Hospital Universitario de Fuenlabrada, Madrid, Spain.'}, {'ForeName': 'Donella', 'Initials': 'D', 'LastName': 'Puliti', 'Affiliation': 'ISPRO, Oncological network, Prevention, and Research Institute, Florence, Italy.'}, {'ForeName': 'Arnauld', 'Initials': 'A', 'LastName': 'Villers', 'Affiliation': 'Department of Urology, CHU Lille, University Lille Nord de France, Lille, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Rebillard', 'Affiliation': 'Urology Department, Clinique Beau Soleil, Montpellier, France.'}, {'ForeName': 'Tuomas P', 'Initials': 'TP', 'LastName': 'Kilpeläinen', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Ulf H', 'Initials': 'UH', 'LastName': 'Stenman', 'Affiliation': 'Department of Pathology, Fimlab Laboratories, Tampere, Finland.'}, {'ForeName': 'Rebecka Arnsrud', 'Initials': 'RA', 'LastName': 'Godtman', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Stinesen Kollberg', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Moss', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventative Medicine, Queen Mary University of London, Charterhouse Square, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Kujala', 'Affiliation': 'Department of Pathology, Fimlab Laboratories, Tampere, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Huber', 'Affiliation': 'Department of Laboratory Medicine, Cantonal Hospital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Theodorus', 'Initials': 'T', 'LastName': 'van der Kwast', 'Affiliation': 'Laboratory Medicine Program, University Health Network, Toronto, Canada.'}, {'ForeName': 'Eveline A', 'Initials': 'EA', 'LastName': 'Heijnsdijk', 'Affiliation': 'Erasmus Medical Centre, Department of Public Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bangma', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'De Koning', 'Affiliation': 'Erasmus Medical Centre, Department of Public Health, Rotterdam, The Netherlands.'}, {'ForeName': 'Fritz H', 'Initials': 'FH', 'LastName': 'Schröder', 'Affiliation': 'Erasmus Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Prostate Cancer Research Center, Faculty of Social Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2019.02.009']
675,31910669,Clinical Outcomes of Dynamic Computed Tomography Myocardial Perfusion Imaging Combined With Coronary Computed Tomography Angiography Versus Coronary Computed Tomography Angiography-Guided Strategy.,"BACKGROUND


Dynamic computed tomography (CT) myocardial perfusion imaging (MPI) provides quantitative myocardial blood flow for the precise assessment of myocardial ischemia. However, compared with coronary CT angiography (CCTA), whether this functional imaging modality can reduce invasive coronary angiography without revascularization remains unknown. We aimed to determine the clinical outcomes of a dynamic CT-MPI+CCTA-guided versus CCTA-guided strategy in patients with suspected coronary artery disease.
METHODS


Consecutive patients with intermediate pretest probability of coronary artery disease were prospectively enrolled and randomized to dynamic CT-MPI+CCTA-guided or CCTA-guided workup. The primary end point was the rate of invasive coronary angiography without revascularization within 3 months. The secondary end point was a composite of major adverse cardiac event at the 3-month, 6-month, and 1-year follow-up.
RESULTS


A total of 240 patients (mean age, 69.01±11.2 years; 173 men) were included. The total radiation dose and contrast media usage within 90 days were higher in the CT-MPI+CCTA group than in the CCTA group (10.3 versus 7.1 mSv,  P =0.031; 134.5±40.6 versus 108.1±48.2 mL,  P <0.0001). Compared with the CCTA-guided group, the CT-MPI+CCTA-guided group had significantly lower rates of invasive coronary angiography within 90 days (48.3% [58/120] versus 30.8% [37/120],  P =0.006) and invasive coronary angiography without revascularization (50.0% [29/58] versus 10.8% [4/37],  P <0.0001). There were no significant differences regarding the frequency of major adverse cardiac event between the 2 groups at the 3-month, 6-month, and 1-year follow-up.
CONCLUSIONS


In patients with intermediate pretest probability of coronary artery disease, CT-MPI+CCTA-guided patient management may be preferred over the CCTA-guided strategy as an approach to reduce unnecessary invasive procedures.",2020,"There were no significant differences regarding the frequency of major adverse cardiac event between the 2 groups at the 3-month, 6-month, and 1-year follow-up.
","['patients with suspected coronary artery disease', '240 patients (mean age, 69.01±11.2 years; 173 men) were included', 'Consecutive patients with intermediate pretest probability of coronary artery disease']","['CT-MPI+CCTA', 'Dynamic Computed Tomography Myocardial Perfusion Imaging Combined With Coronary Computed Tomography Angiography Versus Coronary Computed Tomography Angiography-Guided Strategy', 'Dynamic computed tomography (CT) myocardial perfusion imaging (MPI', 'dynamic CT-MPI+CCTA-guided or CCTA-guided workup', 'dynamic CT-MPI+CCTA-guided versus CCTA-guided strategy', 'CCTA', 'coronary CT angiography (CCTA']","['composite of major adverse cardiac event', 'rate of invasive coronary angiography without revascularization', 'total radiation dose and contrast media usage', 'frequency of major adverse cardiac event', 'rates of invasive coronary angiography', 'invasive coronary angiography without revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2350390', 'cui_str': 'Myocardial Perfusion Imaging'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0009924', 'cui_str': 'Contrast Agents'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",240.0,0.0400139,"There were no significant differences regarding the frequency of major adverse cardiac event between the 2 groups at the 3-month, 6-month, and 1-year follow-up.
","[{'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': ""Institute of Diagnostic and Interventional Radiology (M.Y., X.D., J.Z.), Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Chengxing', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': ""Department of Cardiology (C.S., Z.L.), Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Dai', 'Affiliation': ""Institute of Diagnostic and Interventional Radiology (M.Y., X.D., J.Z.), Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': ""Department of Cardiology (C.S., Z.L.), Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}, {'ForeName': 'Yining', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital (Y.W.), Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, Fuwai Hospital, State Key Laboratory of Cardiovascular Disease, National Centre for Cardiovascular Diseases (B.L.), Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jiayin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Institute of Diagnostic and Interventional Radiology (M.Y., X.D., J.Z.), Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.""}]",Circulation. Cardiovascular imaging,['10.1161/CIRCIMAGING.119.009775']
676,31776659,"The use of accelerometer-based navigation for coronal TKA alignment: a prospective, single surgeon comparative study.","INTRODUCTION


There is the need for a device that can be used to accurately position components during total knee arthroplasty (TKA) with minimal impact on procedure time, workflow and cost. This study aimed to investigate the accuracy and time efficiency of a novel, accelerometer-based navigation system (ABN).
METHODS


This prospective, single surgeon study of patients undergoing TKA for osteoarthritis over a 5 year period involved a total of 138 patients: 110 using the ABN system and 28 without. The ABN system consists of two coupled inertial pods that are secured to resection guides, providing a body-fixed 3D coordinate system for limb segments. Post-operative coronal alignment was measured from standardised long-leg AP radiographs. Deviation of the femur and tibia from the neutral coronal mechanical axis was recorded. Intra-observer repeatability was performed on three independent blinded data sets. The BMI and the surgical time (skin to skin) were recorded for all patients.
RESULTS


The mean BMI was 34 in the ABN group and 33 in the control group (p = 0.92). The skin-to-skin time was also similar between the groups; 105 min in the navigation group and 100 min in the control group (p = 0.297). The use of navigation resulted in significantly fewer outliers as defined by < 3º deviation from the target angle. 3 of 110 navigated patients recorded an AP femur angle of more than 3º from the target of 90º, where 5 of 28 control patients fell outside of the ± 3º window (p = 0.009, Fig. 1).
CONCLUSION


The use of the ABN system significantly improved accuracy of implant position and alignment without increasing surgical time.",2020,The mean BMI was 34 in the ABN group and 33 in the control group (p = 0.92).,['patients undergoing TKA for osteoarthritis over a 5\xa0year period involved a total of 138 patients: 110 using the ABN system and 28 without'],"['accelerometer-based navigation', 'novel, accelerometer-based navigation system (ABN']","['mean BMI', 'accuracy of implant position and alignment without increasing surgical time', 'AP femur angle', 'skin-to-skin time', 'BMI and the surgical time (skin to skin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",138.0,0.030138,The mean BMI was 34 in the ABN group and 33 in the control group (p = 0.92).,"[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'University of Auckland, 85 Park Road, Grafton, Auckland, New Zealand. mzhu031@aucklanduni.ac.nz.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lindsay', 'Affiliation': 'University of Auckland, 85 Park Road, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Keenan', 'Affiliation': 'Auckland District Health Board, 2 Park Road, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monk', 'Affiliation': 'University of Auckland, 85 Park Road, Grafton, Auckland, New Zealand.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Munro', 'Affiliation': 'University of Auckland, 85 Park Road, Grafton, Auckland, New Zealand.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-019-03295-4']
677,31221932,Effect of Music Therapy on Sleep Quality.,"Context


One of the important functions of nurses is to prepare a relaxing environment for patients, for whom they look after and fulfill sleep needs. Today, music therapy, one of nonpharmacological treatment approaches, can be used for enhancing the sleep quality of individuals. The increase of individuals' sleep quality by using music therapy will enable nurses to intervene in problems associated with sleep disorders and prevent insomnia and other relevant problems.
Objective


This study was conducted to determine the effect of music therapy on sleep quality of the students.
Design


The research was an experimental pretest-posttest control group design.
Setting


The research was conducted among the students studying in the nursing department at a university in the east of Turkey in the spring term of the academic year of 2015-2016.
Participant


Students who (1) got a total score of 5 and higher according to the Pittsburgh Sleep Quality Index (PSQI), (2) had no neurological/psychiatric disorder, (3) had no hearing problem, (4) received no medical treatment regarding sleep, and (5) volunteered to participate in the study were included in the study. The students who were included in the study were divided into experimental and control groups.
Invention


Students in the experimental group were instructed to keep the volume of the personal MP3 player to be used for listening to the music therapy below 70% and to use it for 1 h/d at most. No intervention was applied to students in the control group. They were asked to sustain their normal sleeping habits.
Outcome Measure


To collect the data, a questionnaire prepared by the researchers for determining sociodemographic characteristics of the students and PSQI were used.
Results


As a result of the study, it was found that the posttest PSQI mean scores of students in the experimental group, listening to music therapy, were lower than the mean scores of the students in the control group, and the difference between the groups was statistically significant.
Conclusions


As a result of this study, it was determined that music therapy increased the sleep quality of students. Being one of the nonpharmacological treatment approaches intended for solving sleep problems, music therapy is a pain-free, safe, and affordable treatment method without any side effect that could be used in every area of health.",2020,No intervention was applied to students in the control group.,"['students studying in the nursing department at a university in the east of Turkey in the spring term of the academic year of 2015-2016', '2) had no neurological/psychiatric disorder, (3) had no hearing problem, (4) received no medical treatment regarding sleep, and (5) volunteered to participate in the study were included in the study']","['music therapy', 'Music Therapy']","['Pittsburgh Sleep Quality Index (PSQI', ""individuals' sleep quality"", 'Sleep Quality', 'sleep quality', 'posttest PSQI mean scores']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0041400', 'cui_str': 'Turkey'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0011053', 'cui_str': 'Deafness'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0026868', 'cui_str': 'Music Therapy'}]","[{'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0168703,No intervention was applied to students in the control group.,"[{'ForeName': 'Mehtap', 'Initials': 'M', 'LastName': 'Kavurmaci', 'Affiliation': ''}, {'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Dayapoğlu', 'Affiliation': ''}, {'ForeName': 'Mehtap', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
678,31218713,Inhalation Aerosol Therapy in the Treatment of Chronic Rhinosinusitis: A Prospective Randomized Study.,"The purpose of the study was to compare treatment of chronic rhinosinusitis (CRS) with topical glucocorticoids and saline irrigation versus aerosol inhalation therapy. Patients diagnosed with CRS were randomly divided into 2 groups. In the first group, patients were treated with topical glucocorticoids (mometasone furoate, 100 µg in each nostril once daily) and saline irrigation (150 mL twice a day) for 2 weeks. In the second group, patients were treated with inhalation aerosol therapy composed of essential oils, saline, glucocorticoids, and antibiotics, once daily 5 times per week (Monday through Friday), for 2 weeks. The effect of the treatments was compared between the 2 groups. In the first group there was no significant improvement in the Glasgow Health Status Inventory (GHSI) (P = .29). In the second group the improvement in GHSI score was significant (P = .037). It was shown that in the first group the Glasgow Benefit Inventory score was significantly lower than in the second group (P = .002), which means that the improvement in the health status after the therapy was better in the second group. A Lund-Kennedy score showed statistical improvement in both groups (both P < .001). Improvement was also compared between the groups. The results were not significant (P = .11). The authors concluded that, in this preliminary research, inhalation aerosol therapy composed of essential oils, saline, glucocorticoids, and antibiotics led to better subjective results than intranasal glucocorticoid therapy and saline irrigation in the treatment of CRS. Further investigations with more participants, longer periods of treatment, and different validation tools are needed to confirm our results.",2019,In the first group there was no significant improvement in the Glasgow Health Status Inventory (GHSI) (P = .29).,"['Chronic Rhinosinusitis', 'Patients diagnosed with CRS', 'chronic rhinosinusitis (CRS']","['topical glucocorticoids and saline irrigation versus aerosol inhalation therapy', 'topical glucocorticoids (mometasone furoate', 'Inhalation Aerosol Therapy', 'inhalation aerosol therapy composed of essential oils, saline, glucocorticoids, and antibiotics', 'intranasal glucocorticoid therapy and saline irrigation', 'saline irrigation']","['health status', 'Glasgow Health Status Inventory (GHSI', 'Glasgow Benefit Inventory score', 'GHSI score']","[{'cui': 'C0149516', 'cui_str': 'Chronic sinusitis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0001712', 'cui_str': 'Aerosol (substance)'}, {'cui': 'C0021459', 'cui_str': 'Inhalation Therapy'}, {'cui': 'C0066700', 'cui_str': 'mometasone furoate'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C3714568', 'cui_str': 'Aerosol therapy (procedure)'}, {'cui': 'C0028910', 'cui_str': 'Oils, Essential'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}]","[{'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0131279,In the first group there was no significant improvement in the Glasgow Health Status Inventory (GHSI) (P = .29).,"[{'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Velepič', 'Affiliation': 'Clinic of Otorhinolaryngology Head and Neck Surgery, Clinical Medical Centre, University of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Dubravko', 'Initials': 'D', 'LastName': 'Manestar', 'Affiliation': 'Faculty of Medicine, University of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Ivona', 'Initials': 'I', 'LastName': 'Perković', 'Affiliation': 'Clinic of Otorhinolaryngology Head and Neck Surgery, Clinical Medical Centre, University of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Škalamera', 'Affiliation': 'Clinic of Otorhinolaryngology Head and Neck Surgery, Clinical Medical Centre, University of Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Braut', 'Affiliation': 'Clinic of Otorhinolaryngology Head and Neck Surgery, Clinical Medical Centre, University of Rijeka, Rijeka, Croatia.'}]",Journal of clinical pharmacology,['10.1002/jcph.1471']
679,31193736,An exploration of the barriers to attendance at the English Stop Smoking Services.,"Introduction


Despite the availability of effective stop smoking assistance, most smokers do not utilise formal cessation programmes such as the English Stop Smoking Services (SSS). We modified the Treatment Barriers Questionnaire (TBQ), developed in the USA, and distributed it to a sample of English smokers to explore the most important barriers to the use of the SSS.
Methods


Participants of Start2quit, a randomised controlled trial aiming to increase attendance at the SSS using tailored risk information and 'taster' sessions, who reported at follow-up that they had not attended the SSS, were asked to complete the TBQ; 672 (76.9% response rate) were retained for analysis. Principal Component Analysis (PCA) was conducted to examine the structure of the data. Multiple linear regressions were used to determine whether any participant characteristics were associated with particular barriers.
Results


The most commonly endorsed items related to a lack of information on and a lack of confidence in the efficacy of the SSS. PCA yielded seven factors: Work and time constraints (Factor1); Smokers should quit on their own (Factor2); Nothing can help in quitting smoking(Factor3); Disinterest in quitting (Factor4); Lack of social support to attend (Factor5); Lack of privacy at programmes (Factor6); Lack of information and perceived availability (Factor7). Age was associated with Factors 1, 3 and 4, motivation to quit with Factors 2 and 4, and confidence in quitting with Factors 1, 2, and 3.
Conclusions


The findings suggest that many barriers exist, and they vary according to smoker demographics and characteristics, pointing to the need for tailored recruitment strategies.
Trial registration


ISRCTN76561916.",2019,"Age was associated with Factors 1, 3 and 4, motivation to quit with Factors 2 and 4, and confidence in quitting with Factors 1, 2, and 3.
",[],[],[],[],[],[],,0.0540051,"Age was associated with Factors 1, 3 and 4, motivation to quit with Factors 2 and 4, and confidence in quitting with Factors 1, 2, and 3.
","[{'ForeName': 'Dimitra', 'Initials': 'D', 'LastName': 'Kale', 'Affiliation': 'Research Department of Primary Care and Population Health, UCL, London, UK.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Gilbert', 'Affiliation': 'Research Department of Primary Care and Population Health, UCL, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'Institute of Public Health, University of Cambridge, Cambridge, UK.'}]",Addictive behaviors reports,['10.1016/j.abrep.2018.10.005']
680,31790015,A Pilot Study Comparing Effects of Bifrontal Versus Bitemporal Transcranial Direct Current Stimulation in Mild Cognitive Impairment and Mild Alzheimer Disease.,"OBJECTIVE


While transcranial direct current stimulation (tDCS) can enhance aspects of memory in patients with mild cognitive impairment (MCI) and Alzheimer disease (AD), there has been wide variability in both the placement of tDCS electrodes and treatment response. This study compared the effects of bifrontal (anodal stimulation over the dorsolateral prefrontal cortices), bitemporal (anodal stimulation over the temporal cortices), and sham tDCS on cognitive performance in MCI and AD.
METHODS


Seventeen patients diagnosed with MCI or mild AD received 3 sessions of anodal tDCS (bifrontal, bitemporal, 2 mA for 20 minutes; and sham) in random order. Sessions were separated by 1 week. The Alzheimer's Disease Assessment Scale-Cognitive Word Recognition Task, Alzheimer's Disease Assessment Scale-Cognitive Word Recall Task, 2-back, and Montreal Cognitive Assessment were used to assess cognition.
RESULTS


There was a significant effect of stimulation condition on 2-back accuracy (F2,28 = 5.28 P = 0.01, ηp = 0.27), with greater improvements following bitemporal tDCS compared with both bifrontal and sham stimulations. There were no significant changes on other outcome measures following any stimulation. Adverse effects from stimulation were mild and temporary.
CONCLUSIONS


These findings demonstrate that improvements in specific memory tasks can be safely achieved after a single session of bitemporal tDCS in MCI and mild AD patients.",2020,These findings demonstrate that improvements in specific memory tasks can be safely achieved after a single session of bitemporal tDCS in MCI and mild AD patients.,"['Mild Cognitive Impairment and Mild Alzheimer Disease', 'Seventeen patients diagnosed with MCI or mild AD', 'patients with mild cognitive impairment (MCI) and Alzheimer disease (AD']","['transcranial direct current stimulation (tDCS', 'Bifrontal Versus Bitemporal Transcranial Direct Current Stimulation', 'bifrontal (anodal stimulation', 'anodal tDCS (bifrontal, bitemporal, 2 mA for 20 minutes; and sham']","['cognitive performance', 'specific memory tasks', ""Alzheimer's Disease Assessment Scale-Cognitive Word Recognition Task, Alzheimer's Disease Assessment Scale-Cognitive Word Recall Task, 2-back, and Montreal Cognitive Assessment"", '2-back accuracy']","[{'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0445448', 'cui_str': 'Bifrontal (qualifier value)'}, {'cui': 'C0445452', 'cui_str': 'Bitemporal (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C3496286'}]",,0.145084,These findings demonstrate that improvements in specific memory tasks can be safely achieved after a single session of bitemporal tDCS in MCI and mild AD patients.,"[{'ForeName': 'Celina S', 'Initials': 'CS', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pharmacology & Toxicology, University of Toronto.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Herrmann', 'Affiliation': 'Neuropsychopharmacology Research Group, Hurvitz Brain Sciences Program, Sunnybrook Research Institute.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Gallagher', 'Affiliation': 'Neuropsychopharmacology Research Group, Hurvitz Brain Sciences Program, Sunnybrook Research Institute.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Adult Neurodevelopment and Geriatric Psychiatry Division, Centre for Addiction & Mental Health.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kiss', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Vieira', 'Affiliation': 'Neuropsychopharmacology Research Group, Hurvitz Brain Sciences Program, Sunnybrook Research Institute.'}, {'ForeName': 'Krista L', 'Initials': 'KL', 'LastName': 'Lanctôt', 'Affiliation': 'From the Department of Pharmacology & Toxicology, University of Toronto.'}]",The journal of ECT,['10.1097/YCT.0000000000000639']
681,31770081,Effect of Moderate Red Wine versus Vodka Consumption on Inflammatory Markers Related to Cardiovascular Disease Risk: A Randomized Crossover Study.,"Objective:  Few interventions have tested the effects of different alcohol types on cardiovascular risk biomarkers. The aim of this study was to investigate the effects of red wine versus vodka on inflammatory and vascular health-related biomarkers. Methods:  In a crossover study, participants were randomized to receive either red wine or vodka (3 units/day) for 2 weeks. Following a 2-week washout period, participants then consumed the alternate alcoholic drink for 2 weeks. Fasting blood samples were collected just prior to and at the end of each 2-week period. A total of 13 inflammatory and vascular health biomarkers were assessed. Results:  A total of 77 of 85 recruited healthy men completed the study. Leptin levels were significantly raised after each intervention ( p  ≤ 0.01). APO A1 significantly increased following vodka, but not red wine, intervention ( p ≤  0.01). A significant difference between the interventions was noted for adiponectin only ( p  ≤ 0.01), although neither of the within-group changes were statistically significant ( p  > 0.01). Conclusions:  The current study found significantly increased levels of leptin following both red wine and vodka consumption, increased levels of APO A1 following vodka consumption, and significant difference between both interventions for adiponectin only. Further studies are needed to investigate the effects of longer-term alcohol consumption on inflammatory and vascular health biomarkers.",2020,"APO A1 significantly increased following vodka, but not red wine, intervention ( p ≤  0.01).","['Cardiovascular Disease Risk', 'A total of 77 of 85 recruited healthy men completed the study']","['red wine versus vodka', 'Moderate Red Wine versus Vodka Consumption', 'red wine or vodka']","['levels of leptin', 'Fasting blood samples', 'APO A1', 'cardiovascular risk biomarkers', 'adiponectin', 'levels of APO A1 following vodka consumption', 'Leptin levels']","[{'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0349371', 'cui_str': 'Red wine (substance)'}, {'cui': 'C0452263', 'cui_str': 'Vodka (substance)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0853934', 'cui_str': 'Measurement of apolipoprotein A-I (procedure)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0452263', 'cui_str': 'Vodka (substance)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",85.0,0.0457405,"APO A1 significantly increased following vodka, but not red wine, intervention ( p ≤  0.01).","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Wotherspoon', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences B, Belfast, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Elshahat', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences B, Belfast, UK.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'McAlinden', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences B, Belfast, UK.""}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Dean', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences B, Belfast, UK.""}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Young', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences B, Belfast, UK.""}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Sharpe', 'Affiliation': 'Clinical Biochemistry, Craigavon Area Hospital, Craigavon, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Blankenburg', 'Affiliation': 'University Heart Centre Hamburg, Hamburg, Germany.'}, {'ForeName': 'Chris C', 'Initials': 'CC', 'LastName': 'Patterson', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences B, Belfast, UK.""}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'McKinley', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences B, Belfast, UK.""}, {'ForeName': 'Alun', 'Initials': 'A', 'LastName': 'Evans', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences B, Belfast, UK.""}, {'ForeName': 'Jayne V', 'Initials': 'JV', 'LastName': 'Woodside', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Institute of Clinical Sciences B, Belfast, UK.""}]",Journal of the American College of Nutrition,['10.1080/07315724.2019.1695234']
682,31063679,Intraoperative Versus Extended Antibiotic Prophylaxis in Liver Transplant Surgery: A Randomized Controlled Pilot Trial.,"The appropriate duration of surgical antibiotic prophylaxis in orthotopic liver transplantation (OLT) in the presence of significant iatrogenic immunosuppression is unclear. We hypothesized that 72 hours of perioperative antibiotic prophylaxis would decrease rates of surgical site infection (SSI) in OLT patients when compared with intraoperative antibiotic prophylaxis alone. OLT recipients were randomized to receive either intraoperative antibiotics only (short antibiotics [SAs]) or 72 hours of perioperative antibiotics (extended antibiotics [EAs]). A total of 102 patients were randomized: 51 to the EA group and 51 to the SA group. Rates of SSI and nosocomial infection (NI) in the SA group were 19% and 17%, respectively, compared with 27% (SSI; P = 0.36) and 22% (NI; P = 0.47) in the EA group, although these differences were not statistically significant. Intensive care unit (ICU) length of stay (LOS), hospital LOS, 30-day mortality, and time to infection were also similar between the 2 groups. Patients developing infections had longer ICU LOS and hospital LOS and a higher association with reoperation, endoscopic retrograde cholangiopancreatography, and 30-day readmission. In conclusion, extending perioperative antibiotics to 72 hours from intraoperative dosing alone in OLT patients does not appear to decrease the incidence of SSI or NI. The results from this pilot trial with 60% power suggest that it is acceptable for OLT recipients to receive intraoperative antibiotic prophylaxis alone.",2019,"Rates of SSI and nosocomial infection (NI) in the SA group were 19% and 17%, respectively, compared with 27% (SSI; P = 0.36) and 22% (NI; P = 0.47) in the EA group, although these differences were not statistically significant.","['102 patients were randomized: 51 to the EA group and 51 to the SA group', 'Liver Transplant Surgery', 'OLT recipients', 'orthotopic liver transplantation (OLT']","['intraoperative antibiotics only (short antibiotics [SAs]) or 72\xa0hours of perioperative antibiotics (extended antibiotics [EAs', 'Intraoperative Versus Extended Antibiotic Prophylaxis']","['rates of surgical site infection (SSI', 'incidence of SSI or NI', 'reoperation, endoscopic retrograde cholangiopancreatography, and 30-day readmission', 'Rates of SSI and nosocomial infection (NI', 'ICU LOS and hospital LOS', 'Intensive care unit (ICU) length of stay (LOS), hospital LOS, 30-day mortality, and time to infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023911', 'cui_str': 'Transplantation, Hepatic'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0574893', 'cui_str': 'Orthotopic (qualifier value)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}]","[{'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0205721', 'cui_str': 'Infections, Hospital'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",102.0,0.137485,"Rates of SSI and nosocomial infection (NI) in the SA group were 19% and 17%, respectively, compared with 27% (SSI; P = 0.36) and 22% (NI; P = 0.47) in the EA group, although these differences were not statistically significant.","[{'ForeName': 'Puja S', 'Initials': 'PS', 'LastName': 'Berry', 'Affiliation': 'Department of Surgery, University of Virginia Medical Center, Charlottesville, VA.'}, {'ForeName': 'Laura H', 'Initials': 'LH', 'LastName': 'Rosenberger', 'Affiliation': 'Department of Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Guidry', 'Affiliation': 'School of Medicine, Department of Surgery, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Department of Surgery, University of Virginia Medical Center, Charlottesville, VA.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Pelletier', 'Affiliation': 'Department of Surgery, University of Virginia Medical Center, Charlottesville, VA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Sawyer', 'Affiliation': 'Department of Surgery, Western Michigan University, Kalamazoo, MI.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25486']
683,31782265,Acute effects of resonance frequency breathing on cardiovascular regulation.,"Acute slow breathing may have beneficial effects on cardiovascular regulation by affecting hemodynamics and the autonomic nervous system. Whether breathing at the resonance frequency (RF), a breathing rate that maximizes heart rate oscillations, induces differential effects to that of slow breathing is unknown. We compared the acute effects of breathing at either RF and RF + 1 breaths per minute on muscle sympathetic nervous activity (MSNA) and baroreflex function. Ten healthy men underwent MSNA, blood pressure (BP), and heart rate (HR) recordings while breathing for 10 min at their spontaneous breathing (SB) rate followed by 10 min at both RF and RF + 1 randomly assigned and separated by a 10-min recovery. Breathing at either RF or RF + 1 induced similar changes in HR and HR variability, with increased low frequency and decreased high frequency oscillations (p < .001 for both). Both respiration rates decreased MSNA (-5.6 and -7.3 bursts per min for RF and RF + 1 p < .05), with the sympathetic bursts occurring more often during mid-inspiration to early expiration (+57% and + 80%) and longer periods of silence between bursts were seen (p < .05 for RF + 1). Systolic BP was decreased only during RF (-4.6 mmHg, p < .05) but the decrease did not differ to that seen during RF + 1 (-3.1 mmHg). The sympathetic baroreflex function remained unchanged at either breathing rates. The slope of the cardiac baroreflex function was unaltered but the cardiac baroreflex efficiency was improved during both RF and RF + 1. Acute breathing at either RF or RF + 1 has similar hemodynamic and sympatho-inhibitory effects in healthy men.",2019,"Systolic BP was decreased only during RF (-4.6 mmHg, p < .05) but the decrease did not differ to that seen during RF + 1","['healthy men', 'Ten healthy men underwent']","['RF or RF', 'resonance frequency breathing']","['high frequency oscillations', 'cardiac baroreflex efficiency', 'MSNA', 'cardiovascular regulation', 'sympathetic baroreflex function', 'HR and HR variability', 'Systolic BP', 'MSNA, blood pressure (BP), and heart rate (HR) recordings while breathing for 10\xa0min at their spontaneous breathing (SB) rate', 'slope of the cardiac baroreflex function']","[{'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0231881', 'cui_str': 'Resonance, function (observable entity)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0206162', 'cui_str': 'Reflex, Baroreceptor'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}]",10.0,0.0355284,"Systolic BP was decreased only during RF (-4.6 mmHg, p < .05) but the decrease did not differ to that seen during RF + 1","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Pagaduan', 'Affiliation': 'School of Health Sciences, College of Health and Medicine, University of Tasmania, Tasmania, Australia.'}, {'ForeName': 'Sam Sx', 'Initials': 'SS', 'LastName': 'Wu', 'Affiliation': 'School of Health Sciences, College of Health and Medicine, University of Tasmania, Tasmania, Australia.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Kameneva', 'Affiliation': 'Faculty of Science, Engineering and Technology, Swinburne University of Technology, Hawthorn, Victoria, Australia.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lambert', 'Affiliation': 'School of Health Sciences, Department of Health and Medical Sciences, Swinburne University of Technology, Hawthorn, Victoria, Australia.'}]",Physiological reports,['10.14814/phy2.14295']
684,31237158,Radial versus femoral access in patients with acute coronary syndrome undergoing invasive management: A prespecified subgroup analysis from VALIDATE-SWEDEHEART.,"AIMS


In the Bivalirudin versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated according to Recommended Therapies Registry Trial (VALIDATE-SWEDEHEART), bivalirudin was not superior to unfractionated heparin in patients with acute coronary syndrome undergoing invasive management. We assessed whether the access site had an impact on the primary endpoint of death, myocardial infarction or major bleeding at 180 days and whether it interacted with bivalirudin/unfractionated heparin.
METHODS AND RESULTS


A total of 6006 patients with acute coronary syndrome planned for percutaneous coronary intervention were randomised to either bivalirudin or unfractionated heparin. Arterial access was left to the operator discretion. Overall, 90.5% of patients underwent transradial access and 9.5% transfemoral access. Baseline risk was higher in transfemoral access. The unadjusted hazard ratio for the primary outcome was lower with transradial access (hazard ratio 0.53, 95% confidence interval 0.43-0.67,  p <0.001) and remained lower after multivariable adjustment (hazard ratio 0.56, 95% confidence interval 0.52-0.84,  p <0.001). Transradial access was associated with lower risk of death (hazard ratio 0.41, 95% confidence interval 0.28-0.60,  p <0.001) and major bleeding (hazard ratio 0.57, 95% confidence interval 0.44-0.75,  p <0.001). There was no interaction between treatment with bivalirudin and access site for the primary endpoint ( p =0.976) or major bleeding ( p =0.801).
CONCLUSIONS


Transradial access was associated with lower risk of death, myocardial infarction or major bleeding at 180 days. Bivalirudin was not associated with less bleeding, irrespective of access site.",2019,"Transradial access was associated with lower risk of death (hazard ratio 0.41, 95% confidence interval 0.28-0.60,  p <0.001) and major bleeding (hazard ratio 0.57, 95% confidence interval 0.44-0.75,  p <0.001).","['Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease', '6006 patients with acute coronary syndrome planned for percutaneous coronary intervention', 'patients with acute coronary syndrome undergoing invasive management']","['Radial versus femoral access', 'Bivalirudin versus Heparin', 'unfractionated heparin', 'Bivalirudin', 'bivalirudin', 'bivalirudin or unfractionated heparin', 'bivalirudin/unfractionated heparin']","['death, myocardial infarction or major bleeding', 'lower risk of death, myocardial infarction or major bleeding', 'Baseline risk', 'major bleeding', 'risk of death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}]","[{'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",6006.0,0.614289,"Transradial access was associated with lower risk of death (hazard ratio 0.41, 95% confidence interval 0.28-0.60,  p <0.001) and major bleeding (hazard ratio 0.57, 95% confidence interval 0.44-0.75,  p <0.001).","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Völz', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Angerås', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Koul', 'Affiliation': 'Department of Cardiology, Lund University, Sweden.'}, {'ForeName': 'Inger', 'Initials': 'I', 'LastName': 'Haraldsson', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Sarno', 'Affiliation': 'Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Sweden.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Venetsanos', 'Affiliation': 'Department of Cardiology, Karolinska University Hospital, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Grimfärd', 'Affiliation': 'Department of Internal Medicine, Västmanlands Sjukhus, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ulvenstam', 'Affiliation': 'Department of Cardiology, Östersund Hospital, Sweden.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Hofmann', 'Affiliation': 'Department of Clinical Science and Education, Karolinska Institutet, Sweden.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Hamid', 'Affiliation': 'Department of Cardiology, Mälarsjukhuset, Sweden.'}, {'ForeName': 'Loghman', 'Initials': 'L', 'LastName': 'Henareh', 'Affiliation': 'Department of Cardiology, Karolinska University Hospital, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Department of Cardiology, Helsingborg Lasarett, Sweden.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Clinical Science and Education, Karolinska Institutet, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Danielewicz', 'Affiliation': 'Department of Cardiology, Karlstad Hospital, Sweden.'}, {'ForeName': 'Ollie', 'Initials': 'O', 'LastName': 'Östlund', 'Affiliation': 'Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Eriksson', 'Affiliation': 'Department of Cardiology, Umeå University, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Scherstén', 'Affiliation': 'Department of Cardiology, Lund University, Sweden.'}, {'ForeName': 'Rickard', 'Initials': 'R', 'LastName': 'Linder', 'Affiliation': 'Department of Cardiology, Danderyd Hospital, Sweden.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Råmunddal', 'Affiliation': 'Department of Cardiology, Århus University Hospital, Sweden.'}, {'ForeName': 'Pétur', 'Initials': 'P', 'LastName': 'Pétursson', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Fröbert', 'Affiliation': 'Department of Cardiology, Örebro University, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Cardiology, Lund University, Sweden.'}, {'ForeName': 'Elmir', 'Initials': 'E', 'LastName': 'Omerovic', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}]",European heart journal. Acute cardiovascular care,['10.1177/2048872618817217']
685,32409981,Intravenous Tramadol is Effective in the Management of Postoperative Pain Following Abdominoplasty: A Three-Arm Randomized Placebo- and Active-Controlled Trial.,"BACKGROUND AND OBJECTIVE


Oral tramadol, an atypical opioid approved in the United States (US) since 1995 and a Schedule IV controlled substance, has less abuse liability compared to Schedule II conventional opioids. Intravenous (IV) tramadol is not available in the US, but has the potential to fill a gap between non-opioid medications and conventional opioids for treatment of acute pain. This study evaluates IV tramadol in the management of postoperative pain compared to placebo and standard-of-care active control.
METHODS


A phase 3, multicenter, double-blind, three-arm, randomized, placebo- and active-controlled, multiple-dose, parallel-group study was conducted to evaluate the efficacy and safety of 50 mg IV tramadol versus placebo and 4 mg IV morphine over 48 h in patients with postoperative pain following abdominoplasty surgery.
RESULTS


IV tramadol was statistically superior (p < 0.05) to placebo and comparable to IV morphine for the primary and all key secondary efficacy outcomes and demonstrated numerically lower rates for the incidence of most common treatment-emergent adverse events (TEAEs) compared to morphine. No unexpected findings were observed for TEAEs, laboratory tests, vital signs, or electrocardiograms (ECGs). Over 90% of patients completed the study.
CONCLUSION


The study demonstrated that IV tramadol 50 mg is highly effective in the management of postoperative pain following abdominoplasty. The consistency of effects between tramadol and morphine (as compared to placebo) for primary and key secondary endpoints validates the efficacy of tramadol observed. The study also provided direct evidence of improved tolerability of IV tramadol over a standard-of-care conventional Schedule II opioid. IV tramadol may become a useful option in patients where exposure to conventional opioids is not desired.",2020,"RESULTS


IV tramadol was statistically superior (p < 0.05) to placebo and comparable to IV morphine for the primary and all key secondary efficacy outcomes and demonstrated numerically lower rates for the incidence of most common treatment-emergent adverse events (TEAEs) compared to morphine.",['patients with postoperative pain following abdominoplasty surgery'],"['Placebo', 'IV tramadol', 'placebo and standard-of-care active control', 'morphine', 'Abdominoplasty', 'tramadol', '50\xa0mg IV tramadol versus placebo and 4\xa0mg IV morphine', 'Intravenous Tramadol', 'Intravenous (IV) tramadol', 'tramadol and morphine', 'placebo']","['Postoperative Pain', 'postoperative pain', 'TEAEs, laboratory tests, vital signs, or electrocardiograms (ECGs', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.353103,"RESULTS


IV tramadol was statistically superior (p < 0.05) to placebo and comparable to IV morphine for the primary and all key secondary efficacy outcomes and demonstrated numerically lower rates for the incidence of most common treatment-emergent adverse events (TEAEs) compared to morphine.","[{'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Minkowitz', 'Affiliation': 'Clinical Investigation, HD Research, LLC, Bellaire, TX, USA.'}, {'ForeName': 'Hernan', 'Initials': 'H', 'LastName': 'Salazar', 'Affiliation': 'Clinical Investigation, Endeavor Clinical Trials, HD, San Antonio, TX, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leiman', 'Affiliation': 'Clinical Investigation, HD Research, LLC, Bellaire, TX, USA.'}, {'ForeName': 'Daneshvari', 'Initials': 'D', 'LastName': 'Solanki', 'Affiliation': 'Clinical Investigation, HD Research, LLC, Bellaire, TX, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Clinical Research, Avenue Therapeutics, 1140 Avenue of the Americas, 9th Floor, New York, NY, 10036, USA. llu@avenuetx.com.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Reines', 'Affiliation': 'Clinical Research, Avenue Therapeutics, 1140 Avenue of the Americas, 9th Floor, New York, NY, 10036, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'Clinical Research, Avenue Therapeutics, 1140 Avenue of the Americas, 9th Floor, New York, NY, 10036, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harnett', 'Affiliation': 'Clinical Research, Avenue Therapeutics, 1140 Avenue of the Americas, 9th Floor, New York, NY, 10036, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Singla', 'Affiliation': 'Clinical Investigation, Lotus Clinical Research, LLC, Pasadena, CA, USA.'}]",Drugs in R&D,['10.1007/s40268-020-00309-0']
686,31221941,Leukocytapheresis Therapy for Rheumatoid Arthritis: Results Compared with Control Trial.,"Context


Rheumatoid arthritis (RA) is a chronic multisystem autoimmune disease, mainly characterized by synovitis and with symmetrical joint involvement. LCAP therapy for RA patients has been shown to be safe and efficacious in some developed countries for over a decade.
Objective


The study intended to evaluate the efficacy and safety of leukocytopheresis (LCAP) for treatment of rheumatoid arthritis (RA) and to study the influence of treatment on the levels of various serum cytokines.
Design


The study was a nonblinded, nonrandomized, controlled trial.
Setting


The study took place in the Department of Rheumatology and Immunology at Beijing Hospital at the National Center of Gerontology in Beijing, China.
Participants


Participants were 51 patients with RA at the hospital with a 28-joint disease activity score (DAS28) exceeding the 3.20 needed to fulfill the classification criteria of the American College of Rheumatology (ACR).
Intervention


Participants were divided into 2 groups. One group (intervention group) received LCAP therapy (n = 20), while the control group (n = 31) received disease-modifying antirheumatic drugs (DMARDs). Patients receiving the LCAP therapy were treated using a Cellsorba column every 5 days for a total of 5 treatments.
Outcome Measures


Clinical assessment of participants' symptoms included: (1) a tender-joint count, (2) a swollen-joint count, (3) erythrocyte sedimentation rates (ESR), (4) C-reactive protein levels (CRP), (5) a visual analog scale (VAS) for pain, (6) the DAS28 C-reactive protein (DAS28-CRP) scores, and the Health Assessment Questionnaire Disability Index (HAQ-DI). The study also evaluated participants' scores for the American College of Rheumatology (ACR) Core Data Set. Serum collected before and after therapy from both groups was analyzed for the levels of bradykinin, serotonin, heat shock protein 70, human CXC-chemokine ligand 16 (CXCL16), prostaglandin E2, and macrophage inflammation protein 1α.
Results


At week 4 for participants receiving the LCAP therapy, ACR20, ACR50, and ACR70 were observed in 55%, 30%, and 20% of patients, respectively, compared to 19.4%, 3.2%, and 0% for patients in the control group (P < .05). Also, at week 24 of LCAP therapy, ACR20, ACR50, and ACR70 were observed in 70%, 50%, and 30% of patients, respectively, which was significantly higher than the 25.8%, 12.9%, and 3.2% of patients in the control group (P < .05). The serum levels of CXCL16 and serotonin were significantly reduced in the LCAP group compared with control group.
Conclusions


This study indicated that LCAP therapy can significantly decrease RA disease activity and is a safe and effective alternative therapy. LCAP therapy significantly reduced serum CXCL16 and serotonin levels, offering a putative mechanism by which it improves the articular symptoms of RA.",2020,"LCAP therapy significantly reduced serum CXCL16 and serotonin levels, offering a putative mechanism by which it improves the articular symptoms of RA.","[""participants' scores for the American College of Rheumatology (ACR) Core Data Set"", 'rheumatoid arthritis (RA', 'Participants\n\n\nParticipants were 51 patients with RA at the hospital with a 28-joint disease activity score (DAS28) exceeding the 3.20 needed to fulfill the classification criteria of the American College of Rheumatology (ACR', 'Rheumatoid Arthritis', 'Department of Rheumatology and Immunology at Beijing Hospital at the National Center of Gerontology in Beijing, China']","['LCAP', 'disease-modifying antirheumatic drugs (DMARDs', 'leukocytopheresis (LCAP', 'Leukocytapheresis Therapy', 'LCAP therapy']","['ACR20, ACR50, and ACR70', ""Outcome Measures\n\n\nClinical assessment of participants' symptoms included: (1) a tender-joint count, (2) a swollen-joint count, (3) erythrocyte sedimentation rates (ESR), (4) C-reactive protein levels (CRP), (5) a visual analog scale (VAS) for pain, (6) the DAS28 C-reactive protein (DAS28-CRP) scores, and the Health Assessment Questionnaire Disability Index (HAQ-DI"", 'serum CXCL16 and serotonin levels', 'serum levels of CXCL16 and serotonin', 'RA disease activity']","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205767', 'cui_str': 'Gerontology'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0242708', 'cui_str': 'Antirheumatic Drugs, Disease-Modifying'}, {'cui': 'C0023416', 'cui_str': 'Leukocytapheresis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0451530', 'cui_str': 'Tender joint count (assessment scale)'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count (assessment scale)'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",51.0,0.0219527,"LCAP therapy significantly reduced serum CXCL16 and serotonin levels, offering a putative mechanism by which it improves the articular symptoms of RA.","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yongjing', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Yingjuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Bingyao', 'Initials': 'B', 'LastName': 'Mu', 'Affiliation': ''}, {'ForeName': 'Rongwei', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Cibo', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
687,31774510,The Effectiveness of Platelet-Rich Plasma and Radial Extracorporeal Shock Wave Compared with Platelet-Rich Plasma in the Treatment of Moderate Carpal Tunnel Syndrome.,"OBJECTIVES


To evaluate the combination effect of platelet-rich plasma (PRP) and extracorporeal shock wave therapy (ESWT) for moderate carpal tunnel syndrome (CTS), compared with PRP alone.
DESIGN


A randomized, double-blinded, placebo-controlled trial.
SETTING


A single medical center in Taiwan.
PATIENTS


Patients diagnosed with moderate CTS.
INTERVENTIONS


All subjects were administered one dose of ultrasound-guided PRP injection at baseline. After two weeks, one session of rESWT was completed in the intervention group, whereas the control group received one session of sham rESWT. Evaluations were performed at baseline and one, three, and six months post-PRP injection.
OUTCOME MEASURES


The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) was measured as the primary outcome. Electrophysiological study and cross-sectional area (CSA) of the median nerve were used as secondary outcomes.
RESULTS


All 40 enrolled subjects (male/female: 4/36) completed the study, resulting in an analysis of 32 wrists per group (total: N = 64 wrists). Compared with the control group, the intervention group did not show statistically significantly superior outcomes, except in BCTQs at one month (mean change ± SE = -11.47 ± 1.18 vs -7.06 ± 1.26, P = 0.013) and distal motor latency at three months (mean change ± SE = -0.59 ± 0.09 vs -0.30 ± 0.09, P = 0.031).
CONCLUSIONS


Combined PRP and one-session rESWT was not superior to PRP alone in treating moderate CTS. Further studies with multiple sessions of ESWT and longer follow-up periods are needed to verify the clinical efficacy of ESWT.",2020,"Compared with the control group, the intervention group did not show statistically significantly superior outcomes, except in BCTQs at one month (mean change ± SE = -11.47 ± 1.18 vs -7.06 ± 1.26, P = 0.013) and distal motor latency at three months (mean change ± SE = -0.59 ± 0.09 vs -0.30 ± 0.09, P = 0.031).
","['Patients diagnosed with moderate CTS', 'Moderate Carpal Tunnel Syndrome', 'A single medical center in Taiwan', 'moderate carpal tunnel syndrome (CTS', 'All 40 enrolled subjects (male/female: 4/36) completed the study, resulting in an analysis of 32 wrists per group (total: N\u2009=\u200964 wrists']","['control group received one session of sham rESWT', 'ultrasound-guided PRP injection', 'placebo', 'ESWT', 'platelet-rich plasma (PRP) and extracorporeal shock wave therapy (ESWT', 'Platelet-Rich Plasma and Radial Extracorporeal Shock Wave Compared with Platelet-Rich Plasma']","['distal motor latency', 'Boston Carpal Tunnel Syndrome Questionnaire (BCTQ', 'BCTQs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0442087', 'cui_str': 'Extracorporeal (qualifier value)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}]","[{'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Amyotrophy, Thenar, Of Carpal Origin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",40.0,0.0474861,"Compared with the control group, the intervention group did not show statistically significantly superior outcomes, except in BCTQs at one month (mean change ± SE = -11.47 ± 1.18 vs -7.06 ± 1.26, P = 0.013) and distal motor latency at three months (mean change ± SE = -0.59 ± 0.09 vs -0.30 ± 0.09, P = 0.031).
","[{'ForeName': 'Chih-Ya', 'Initials': 'CY', 'LastName': 'Chang', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Liang-Cheng', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Yu-Ching', 'Initials': 'YC', 'LastName': 'Chou', 'Affiliation': 'School of Public Health, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Tsung-Ying', 'Initials': 'TY', 'LastName': 'Li', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Tsung-Yen', 'Initials': 'TY', 'LastName': 'Ho', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}, {'ForeName': 'Yung-Tsan', 'Initials': 'YT', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center, Taipei, Taiwan, Republic of China.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz309']
688,31739087,Gender differences in mortality and quality of life after septic shock: A post-hoc analysis of the ARISE study.,"PURPOSE


To assess the impact of gender and pre-menopausal state on short- and long-term outcomes in patients with septic shock.
MATERIAL AND METHODS


Cohort study of the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial, an international randomized controlled trial comparing early goal-directed therapy (EGDT) to usual care in patients with early septic shock, conducted between October 2008 and April 2014. The primary exposure in this analysis was legal gender and the secondary exposure was pre-menopausal state defined by chronological age (≤ 50 years).
RESULTS


641 (40.3%) of all 1591 ARISE trial participants in the intention-to-treat population were females and overall, 337 (21.2%) (146 females) patients were 50  years of age or younger. After risk-adjustment, we could not identify any survival benefit for female patients at day 90 in the younger (≤50 years) (adjusted Odds Ratio (aOR): 0.91 (0.46-1.89), p = .85) nor in the older (>50 years) age-group (aOR: 1.10 (0.81-1.49), p = .56). Similarly, there was no gender-difference in ICU, hospital, 1-year mortality nor quality of life measures.
CONCLUSIONS


This post-hoc analysis of a large multi-center trial in early septic shock has shown no short- or long-term survival effect for women overall as well as in the pre-menopausal age-group.",2020,"Similarly, there was no gender-difference in ICU, hospital, 1-year mortality nor quality of life measures.
","['Cohort study of the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial', 'female patients at day 90 in the younger (≤50\u202fyears) (adjusted Odds Ratio (aOR', 'patients with septic shock', '146 females) patients were 50\u202f years of age or younger', 'patients with early septic shock, conducted between October 2008 and April 2014']",['goal-directed therapy (EGDT'],"['mortality and quality of life', 'ICU, hospital, 1-year mortality nor quality of life measures', 'survival benefit']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C1271494', 'cui_str': 'Goal directed therapy (regime/therapy)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0034380'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.490644,"Similarly, there was no gender-difference in ICU, hospital, 1-year mortality nor quality of life measures.
","[{'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Luethi', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia. Electronic address: nora.luethi@insel.ch.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Higgins', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Howe', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Peake', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia; Department of Intensive Care Medicine, The Queen Elizabeth Hospital, Adelaide, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Delaney', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia; Department of Intensive Care Medicine, Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia; Department of Intensive Care, Austin Hospital, Heidelberg, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of critical care,['10.1016/j.jcrc.2019.11.002']
689,31784702,Observation of topical tacrolimus on high-risk penetrating keratoplasty patients: a randomized clinical trial study.,"BACKGROUND/OBJECTIVES


To evaluate the clinical efficacy of topical tacrolimus 0.1% and cyclosporine 1% on high-risk penetrating keratoplasty (PKP) patients.
SUBJECTS/METHODS


A series of 49 high-risk PKP patients (49 eyes), 20 males, 29 females from the age of 4 months to 74 years of age with the mean of 32.5 from 2012 to 2017 were recruited in this study. The patients were randomly divided into two groups by receiving either topical tacrolimus 0.1% or cyclosporine 1% respectively. Twenty five patients were treated with topical tacrolimus 0.1% and 24 patients with topical cyclosporine 1%. The traditional baseline management on these two groups were Tobramycin and Dexamethasone eye drops in the first 3 weeks and then tapered off. Clinical procedures and postoperative follow-up were documented.
RESULTS


After 6-54 months follow-up, with the average of 24 months, 11 of 24 high-risk patients (11 eyes) had graft rejection, the rejection rate was 45.8% in topical cyclosporine 1% group. The rejections occurred from 35 days to 20 months after PKP. Three patients had irreversible rejection. On topical tacrolimus 0.1% group, the rejection occurred in four patients (four eyes) with rejection rate of 16%, and no irreversible rejection was observed. The graft rejection episodes were documented between 23 days and 24 months. As compared with the topical cyclosporine 1%, topical tacrolimus 0.1%, a key immunosuppressant, significantly decreased corneal graft rejection rate (p = 0.02).
CONCLUSIONS


Topical tacrolimus 01% on high-risk PKP patients significantly prevented corneal graft rejection, and it had less adverse effects and was very safe to high-risk patients as to topical cyclosporine 1%. Further case controlled randomized clinical trial studies are needed to establish the best management option for these high-risk patients.",2020,"On topical tacrolimus 0.1% group, the rejection occurred in four patients (four eyes) with rejection rate of 16%, and no irreversible rejection was observed.","['49 high-risk PKP patients (49 eyes), 20 males, 29 females from the age of 4 months to 74 years of age with the mean of 32.5 from 2012 to 2017 were recruited in this study', 'high-risk penetrating keratoplasty (PKP) patients', 'high-risk penetrating keratoplasty patients', 'Twenty five patients were treated with']","['topical cyclosporine', 'Topical tacrolimus', 'topical tacrolimus', 'Tobramycin and Dexamethasone', 'topical tacrolimus 0.1% or cyclosporine', 'cyclosporine']","['rejection rate', 'graft rejection, the rejection rate', 'graft rejection episodes', 'rejections', 'corneal graft rejection', 'rejection', 'irreversible rejection', 'corneal graft rejection rate', 'adverse effects']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517710', 'cui_str': '32.5 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0022592', 'cui_str': 'Keratoplasty, Penetrating'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0018129', 'cui_str': 'Transplantation Rejection'}, {'cui': 'C0877542', 'cui_str': 'Graft rejection episode'}, {'cui': 'C0339303', 'cui_str': 'Corneal graft rejection (disorder)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",2017.0,0.0279068,"On topical tacrolimus 0.1% group, the rejection occurred in four patients (four eyes) with rejection rate of 16%, and no irreversible rejection was observed.","[{'ForeName': 'Li-Ying', 'Initials': 'LY', 'LastName': 'Zhai', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China.'}, {'ForeName': 'Xiao-Rong', 'Initials': 'XR', 'LastName': 'Zhang', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China. zxr1110@sina.com.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China.'}, {'ForeName': 'Hong-Chang', 'Initials': 'HC', 'LastName': 'Xu', 'Affiliation': 'Division of Ocular Injuries, Department of Ophthalmology, The Third Affiliated Hospital of Hebei Medical University, Shijiazhuang, 050051, Hebei, China.'}]","Eye (London, England)",['10.1038/s41433-019-0717-3']
690,31782656,The feasibility of low-intensity psychological therapy for depression co-occurring with autism in adults: The Autism Depression Trial (ADEPT) - a pilot randomised controlled trial.,"Low-intensity cognitive behaviour therapy including behavioural activation is an evidence-based treatment for depression, a condition frequently co-occurring with autism. The feasibility of adapting low-intensity cognitive behaviour therapy for depression to meet the needs of autistic adults via a randomised controlled trial was investigated. The adapted intervention (guided self-help) comprised materials for nine individual sessions with a low-intensity psychological therapist. Autistic adults (n = 70) with depression (Patient Health Questionnaire-9 score ⩾10) recruited from National Health Service adult autism services and research cohorts were randomly allocated to guided self-help or treatment as usual. Outcomes at 10-, 16- and 24-weeks post-randomisation were blind to treatment group. Rates of retention in the study differed by treatment group with more participants attending follow-up in the guided self-help group than treatment as usual. The adapted intervention was well-received, 86% (n = 30/35) of participants attended the pre-defined 'dose' of five sessions of treatment and 71% (25/35) attended all treatment sessions. The findings of this pilot randomised controlled trial indicate that low-intensity cognitive behaviour therapy informed by behavioural activation can be successfully adapted to meet the needs of autistic people. Evaluation of the effectiveness of this intervention in a full scale randomised controlled trial is now warranted.",2020,Rates of retention in the study differed by treatment group with more participants attending follow-up in the guided self-help group than treatment as usual.,"['depression co-occurring with autism in adults', 'autistic adults', 'Autistic adults (n\u2009=\u200970) with depression (Patient Health Questionnaire-9 score ⩾10) recruited from National Health Service adult autism services and research cohorts']","['adapting low-intensity cognitive behaviour therapy', 'adapted intervention (guided self-help) comprised materials for nine individual sessions with a low-intensity psychological therapist', 'low-intensity psychological therapy', 'Low-intensity cognitive behaviour therapy', 'guided self-help or treatment as usual', 'low-intensity cognitive behaviour therapy']",['Rates of retention'],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0035168'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.170748,Rates of retention in the study differed by treatment group with more participants attending follow-up in the guided self-help group than treatment as usual.,"[{'ForeName': 'Ailsa', 'Initials': 'A', 'LastName': 'Russell', 'Affiliation': 'University of Bath, UK.'}, {'ForeName': 'Daisy M', 'Initials': 'DM', 'LastName': 'Gaunt', 'Affiliation': 'University of Bristol, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'University of Bath, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Barton', 'Affiliation': 'Northumberland, Tyne and Wear NHS Foundation Trust, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'University of Bristol, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kessler', 'Affiliation': 'University of Bristol, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'University of Bristol, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ensum', 'Affiliation': 'Avon and Wiltshire Mental Health Partnership NHS Trust, UK.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Ingham', 'Affiliation': 'Northumberland, Tyne and Wear NHS Foundation Trust, UK.'}, {'ForeName': 'Jeremy R', 'Initials': 'JR', 'LastName': 'Parr', 'Affiliation': 'Northumberland, Tyne and Wear NHS Foundation Trust, UK.'}, {'ForeName': 'Dheeraj', 'Initials': 'D', 'LastName': 'Rai', 'Affiliation': 'University of Bristol, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Wiles', 'Affiliation': 'University of Bristol, UK.'}]",Autism : the international journal of research and practice,['10.1177/1362361319889272']
691,30998610,Effects of different strategies on high thrombus burden in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary catheterization.,"OBJECTIVE


This study aimed at evaluating efficacy and safety of thrombus aspiration and intracoronary-targeted thrombolysis on coronary thrombus burden in ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous catheterization, comparing their effects on myocardial perfusion through index of microcirculatory resistance (IMR) and single-photon emission computed tomography (SPECT).
PARTICIPANTS AND METHODS


From January 2017 to January 2018, STEMI patients with high thrombus burden undergoing primary catheterization were enrolled and randomly assigned to receiving thrombus aspiration (TA group) or intracoronary thrombolysis (IT group). IMR, SPECT, and other conventional measurements were adopted to assess myocardial perfusion. Major adverse cardiovascular events (MACEs) and complications were recorded over a 90-day follow-up and a 12-month follow-up after the procedure.
RESULTS


The study consisted of 38 patients in the IT group and 33 in the TA group. After recanalization, thrombus burden score, corrected thrombolysis in myocardial infarction (TIMI) frame count, the proportion of TIMI myocardial perfusion 3 grade, and IMR in the IT group were significantly better than those of the TA group (P<0.05). During the 90-day follow-up, no difference was observed in cardiac function and MACEs. During the 12-month follow-up, there were significant differences in infarct size of SPECT (18.56±8.56 vs. 22.67±7.66, P=0.046), left ventricular ejection fraction of echocardiography (58.13±5.92 vs. 55.17±5.68, P=0.043), and the composite MACEs between the two groups (P=0.034).
CONCLUSION


Thrombus aspiration and intracoronary-targeted thrombolysis are effective and safe strategies in managing high coronary thrombus burden in STEMI patients. Compared with aspiration, intracoronary-targeted thrombolysis is more beneficial in improving myocardial microcirculation perfusion.",2019,"During the 90-day follow-up, no difference was observed in cardiac function and MACEs.","['ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous catheterization', 'patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary catheterization', 'From January 2017 to January 2018, STEMI patients with high thrombus burden undergoing primary catheterization', '38 patients in the IT group and 33 in the TA group']","['thrombus aspiration (TA group) or intracoronary thrombolysis', 'thrombus aspiration and intracoronary-targeted thrombolysis', 'aspiration, intracoronary-targeted thrombolysis']","['Major adverse cardiovascular events (MACEs) and complications', 'infarct size of SPECT', 'composite MACEs', 'left ventricular ejection fraction of echocardiography', 'myocardial microcirculation perfusion', 'cardiac function and MACEs', 'thrombus burden score, corrected thrombolysis in myocardial infarction (TIMI) frame count, the proportion of TIMI myocardial perfusion 3 grade, and IMR']","[{'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0040399', 'cui_str': 'SPECT'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0180979', 'cui_str': 'Frame (physical object)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion (observable entity)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",,0.0452366,"During the 90-day follow-up, no difference was observed in cardiac function and MACEs.","[{'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yanming', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Yanqiang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Wenlu', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ''}]",Coronary artery disease,['10.1097/MCA.0000000000000743']
692,30346543,A randomized controlled trial to improve engagement of hospitalized patients with their patient portals.,"Objectives


To test a patient-centered, tablet-based bedside educational intervention in the hospital and to evaluate the efficacy of this intervention to increase patient engagement with their patient portals during hospitalization and after discharge.
Materials and Methods


We conducted a randomized controlled trial of adult patients admitted to the hospitalist service in one large, academic medical center. All participants were supplied with a tablet computer for 1 day during their inpatient stay and assistance with portal registration and initial login as needed. Additionally, intervention group patients received a focused bedside education to demonstrate key functions of the portal and explain the importance of these functions to their upcoming transition to post-discharge care. Our primary outcomes were proportion of patients who logged into the portal and completed specific tasks after discharge. Secondary outcomes were observed ability to navigate the portal before discharge and self-reported patient satisfaction with bedside tablet use to access the portal.
Results


We enrolled 97 participants (50 intervention; 47 control); overall 57% logged into their portals ≥1 time within 7 days of discharge (58% intervention vs. 55% control). Mean number of logins was higher for the intervention group (3.48 vs. 2.94 control), and mean number of specific portal tasks performed was higher in the intervention group; however, no individual comparison reached statistical significance. Observed ability to login and navigate the portal in the hospital was higher for the intervention group (64% vs. 60% control), but only 1 specific portal task was significant (view provider messaging tab: 92% vs. 77% control, P = .04). Time needed to deliver the intervention was brief (<15 min for 80%), and satisfaction with the bedside tablet to access the portal was high in the intervention group (88% satisfied/very satisfied).
Conclusion


Our intervention was highly feasible and acceptable to patients, and we found a highly consistent, but statistically non-significant, trend towards higher inpatient engagement and post-discharge use of key portal functions among patients in the intervention group.",2018,"Mean number of logins was higher for the intervention group (3.48 vs. 2.94 control), and mean number of specific portal tasks performed was higher in the intervention group; however, no individual comparison reached statistical significance.","['adult patients admitted to the hospitalist service in one large, academic medical center', 'hospitalized patients with their patient portals', 'We enrolled 97 participants (50 intervention; 47 control); overall 57% logged into their portals ≥1 time within 7 days of discharge (58% intervention vs. 55% control']","['bedside education', 'patient-centered, tablet-based bedside educational intervention']","['ability to navigate the portal before discharge and self-reported patient satisfaction with bedside tablet use to access the portal', 'Observed ability to login and navigate the portal in the hospital', 'specific portal task', 'proportion of patients who logged into the portal and completed specific tasks', 'inpatient engagement and post-discharge use of key portal functions', 'mean number of specific portal tasks', 'Mean number of logins']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600620', 'cui_str': 'Hospitalists'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C4277550', 'cui_str': 'Patient Internet Portals'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",97.0,0.0847673,"Mean number of logins was higher for the intervention group (3.48 vs. 2.94 control), and mean number of specific portal tasks performed was higher in the intervention group; however, no individual comparison reached statistical significance.","[{'ForeName': 'S Ryan', 'Initials': 'SR', 'LastName': 'Greysen', 'Affiliation': 'Section of Hospital Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Harrison', 'Affiliation': 'Division of Hospital Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Rareshide', 'Affiliation': 'Center for Health Care Innovation, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Yimdriuska', 'Initials': 'Y', 'LastName': 'Magan', 'Affiliation': 'School of Medicine, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Seghal', 'Affiliation': 'School of Public Health, University of Maryland, College Park, College Park, MD, USA.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Rosenthal', 'Affiliation': 'School of Medicine, Boston University, Boston, MA, USA, and.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Jacolbia', 'Affiliation': 'School of Nursing, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Auerbach', 'Affiliation': 'Division of Hospital Medicine, University of California San Francisco, San Francisco, CA, USA.'}]",Journal of the American Medical Informatics Association : JAMIA,['10.1093/jamia/ocy125']
693,31188644,Evidence of a Ceiling Effect for Training Volume in Muscle Hypertrophy and Strength in Trained Men - Less is More?,"PURPOSE


To compare the effects of different resistance training volumes on muscle performance and hypertrophy in trained men.
METHODS


37 volunteers performed resistance training for 24 weeks, divided into groups that performed five (G5), 10 (G10), 15 (G15) and 20 (G20) sets per muscle group per week. Ten repetition maximum (10RM) tests were performed for the bench press, lat pull down, 45º leg press, and stiff legged deadlift. Muscle thickness (MT) was measured using ultrasound at biceps brachii, triceps brachii, pectoralis major, quadriceps femoris and gluteus maximus. All measurements were performed at the beginning (pre) and after 12 (mid) and 24 weeks (post).
RESULTS


All groups showed significant increases in all 10RM tests and MT measures after 12 and 24 weeks when compared to pre (p <0.05). There were no significant differences in any 10RM test or changes between G5 and G10 after 12 and 24 weeks. G5 and G10 showed significantly greater increases for 10RM than G15 and G20 for most exercises at 12 and 24 weeks. There were no group by time interaction for any MT measure.
CONCLUSIONS


The results bring evidence of an inverted ""U shaped"" curve for the dose response curve for muscle strength. Whilst the same trend was noted for muscle hypertrophy, the results did not reach significance. Five to 10 sets per week might be sufficient for bringing about optimal gains in muscle size and strength in trained men over a 24-week period.",2020,There were no significant differences in any 10RM test or changes between G5 and G10 after 12 and 24 weeks.,"['37 volunteers performed', 'trained men']","['resistance training volumes', 'resistance training']","['10RM', 'muscle hypertrophy', '10RM tests and MT measures', 'Muscle thickness (MT', 'time interaction for any MT measure', 'muscle performance and hypertrophy']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]","[{'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}]",37.0,0.0145495,There were no significant differences in any 10RM test or changes between G5 and G10 after 12 and 24 weeks.,"[{'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Barbalho', 'Affiliation': '1 Centro de Ciências Biológicas e da Saúde, Universidade da Amazônia, Belém, Pará, Brasil.'}, {'ForeName': 'Victor Silveira', 'Initials': 'VS', 'LastName': 'Coswig', 'Affiliation': '3 Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, Pará, Brasil.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Steele', 'Affiliation': '4 School of Sport, Health and Social Sciences, Southampton Solent University, Southampton, UK.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Fisher', 'Affiliation': '4 School of Sport, Health and Social Sciences, Southampton Solent University, Southampton, UK.'}, {'ForeName': 'Jurgen', 'Initials': 'J', 'LastName': 'Giessing', 'Affiliation': '6 Institute of Sport Science, University of Koblenz-Landau, Landau, Germany.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Gentil', 'Affiliation': '1 Centro de Ciências Biológicas e da Saúde, Universidade da Amazônia, Belém, Pará, Brasil.'}]",International journal of sports physiology and performance,['10.1123/ijspp.2018-0914']
694,31769377,"Efficacy of trial-based cognitive therapy, behavioral activation and treatment as usual in the treatment of major depressive disorder: preliminary findings from a randomized clinical trial.","INTRODUCTION.


Major depressive disorder (MDD) is a prevalent, debilitating and disabling disorder, and its prevalence is increasing. Antidepressants (AD), cognitive-behavioral therapy (CBT) and behavioral activation (BA) are the main treatments for MDD. Trial-based cognitive therapy (TBCT) addresses and restructures dysfunctional negative core beliefs (CBs) and is a novel and promising approach.
OBJECTIVE.


The aim of this study was to compare the efficacy of TBCT, BA and treatment as usual (TAU) in the treatment of MDD.
METHODS.


A total of 76 patients with MDD were randomized into 1 of 3 groups and evaluated at baseline, after 6 weeks and at week 12 (final evaluation). The primary outcome was changing in HAM-D scores, and the secondary outcomes included scores on the BDI, CD-Quest, Sheehan Disability Scale (SDS) and WHOQOL.
RESULTS.


Both TBCT and BA (which also included AD) were different from TAU (which included antidepressants alone) in reducing the HAM-D and BDI scores and other measures. TBCT and BA were different from TAU in the reduction of disability in SDS and WHOQOL physical domain scores. Besides limited by a small sample size, the dropout rate in the TAU arm was higher, and only 10 patients completed the 3 evaluations.
CONCLUSION.


This trial provides evidence that TBCT and BA combined with antidepressants were more efficacious than the TAU (drug alone) in reducing the severity of depressive symptoms and disability, showing that this combination can be useful for clinical practice.",2020,TBCT and BA were different from TAU in the reduction of disability in SDS and WHOQOL physical domain scores.,"['Major depressive disorder (MDD', '76 patients with MDD', 'major depressive disorder']","['Antidepressants (AD), cognitive-behavioral therapy (CBT) and behavioral activation (BA', 'cognitive therapy (TBCT', 'TBCT', 'trial-based cognitive therapy, behavioral activation', 'TBCT, BA']","['scores on the BDI, CD-Quest, Sheehan Disability Scale (SDS) and WHOQOL', 'disability in SDS and WHOQOL physical domain scores', 'HAM-D and BDI scores', 'TBCT and BA', 'changing in HAM-D scores']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",76.0,0.0804249,TBCT and BA were different from TAU in the reduction of disability in SDS and WHOQOL physical domain scores.,"[{'ForeName': 'Curt', 'Initials': 'C', 'LastName': 'Hemanny', 'Affiliation': 'Postgraduate Program of Interactive Processes of Organs and Systems, Health Sciences Institute, Federal University of Bahia, Brazil.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Carvalho', 'Affiliation': 'Postgraduate Program of Interactive Processes of Organs and Systems, Health Sciences Institute, Federal University of Bahia, Brazil.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Maia', 'Affiliation': 'Postgraduate Program of Interactive Processes of Organs and Systems, Health Sciences Institute, Federal University of Bahia, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Reis', 'Affiliation': 'Postgraduate Program of Interactive Processes of Organs and Systems, Health Sciences Institute, Federal University of Bahia, Brazil.'}, {'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'Botelho', 'Affiliation': 'Postgraduate Program of Interactive Processes of Organs and Systems, Health Sciences Institute, Federal University of Bahia, Brazil.'}, {'ForeName': 'Dagoberto', 'Initials': 'D', 'LastName': 'Bonavides', 'Affiliation': 'Postgraduate Program of Interactive Processes of Organs and Systems, Health Sciences Institute, Federal University of Bahia, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Seixas', 'Affiliation': 'Postgraduate Program of Interactive Processes of Organs and Systems, Health Sciences Institute, Federal University of Bahia, Brazil.'}, {'ForeName': 'Irismar Reis', 'Initials': 'IR', 'LastName': 'de Oliveira', 'Affiliation': 'Postgraduate Program of Interactive Processes of Organs and Systems, Health Sciences Institute, Federal University of Bahia, Brazil.'}]",CNS spectrums,['10.1017/S1092852919001457']
695,31784704,Efficacy and safety of subthreshold micropulse laser compared with threshold conventional laser in central serous chorioretinopathy.,"PURPOSE


To compare the efficacy and safety of subthreshold micropulse laser (SML) with threshold conventional laser (TCL) in central serous chorioretinopathy (CSC).
METHODS


Prospective, randomized, double-masked, non-inferiority, 12-week clinical trial. Patients were randomly assigned 1:1 to SML group or TCL group. Patients in the SML group were treated with 577 nm micropulse laser. The spot size was 160 µm, the duty cycle was 5% and exposure time was 0.2 s. The power was 50% threshold tested. Patients in the TCL group were treated with 577 nm continuous laser. The power was 100% threshold tested. The primary outcome was the mean change in best-corrected visual acuity (BCVA) at week 12, with a non-inferiority limit of five letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts.
RESULTS


Eighty-eight patients were enroled. Seventy-seven patients were male. Forty-four patients were in SML group and 44 in TCL group. At week 12, SML was equivalent to TCL with a gain of 6.23 ± 8.59 and 6.61 ± 6.35 letters, respectively, (SML-TCL difference: -0.38 letters; 95% confidence interval (CI):-3.58-2.81; P non-inferiority  = 0.0026). There was no statistically significant difference between the two groups (t = 0.240, P = 0.811). At week 12, the proportion of patients whose SRF had been totally absorbed was 63.63 and 81.82% respectively for SML and TCL groups. There was no statistically significant difference between the two groups (χ 2  = 3.67, P = 0.056).
CONCLUSIONS


Both SML and TCL can improve visual acuity in CSC. SML was non-inferior to TCL in the improvement of BCVA.",2020,"There was no statistically significant difference between the two groups (χ 2  = 3.67, P = 0.056).
","['Forty-four patients were in SML group and 44 in TCL group', 'Eighty-eight patients were enroled', 'central serous chorioretinopathy (CSC', 'Seventy-seven patients were male', 'central serous chorioretinopathy']","['subthreshold micropulse laser compared with threshold conventional laser', 'subthreshold micropulse laser (SML) with threshold conventional laser (TCL', 'TCL', '577\u2009nm continuous laser', '577\u2009nm micropulse laser', 'SML group or TCL', 'SML', 'SML and TCL']","['spot size', 'efficacy and safety', 'mean change in best-corrected visual acuity (BCVA', 'Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts', 'Efficacy and safety', 'visual acuity']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0730328', 'cui_str': 'Central Serous Retinopathy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0183370', 'cui_str': 'Snellen eye chart'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",88.0,0.177868,"There was no statistically significant difference between the two groups (χ 2  = 3.67, P = 0.056).
","[{'ForeName': 'Zuhua', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Chaochao', 'Initials': 'C', 'LastName': 'Nie', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Pei', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Zhou', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Junyan', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Bothwin Clinical Study Consultant, Redmond, WA, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Chong', 'Affiliation': 'Optegra Eye Hospital, London, UK.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Ophthalmology & Optometry and Eye Hospital, Wenzhou Medical University, 270 Xueyuan Road, Wenzhou, Zhejiang, China. drliuxiaolin@163.com.'}]","Eye (London, England)",['10.1038/s41433-019-0692-8']
696,31784809,Randomized controlled trial comparing mini-sling with transobturator sling for the treatment of stress urinary incontinence.,"INTRODUCTION AND HYPOTHESIS


Stress urinary incontinence (SUI) is the involuntary loss of urine on effort and is a condition that negatively interferes with various aspects of a woman's life. This study aimed to demonstrate the non-inferiority of the less invasive single-incision mini-sling (SIMS) method in objective and subjective cures in relation to tension-free transobturator tape (TOT) in two analyses, per protocol and intention to treat, and secondarily to evaluate complications and quality of life.
METHODS


This study was a randomized controlled trial (RCT). Participants in this study included 105 women with a clinical diagnosis of stress predominant urinary incontinence and urodynamic results demonstrating SUI and absence of detrusor overactivity. Patients were evaluated pre- and postoperatively through anamnesis, physical examination, urinalysis, urine culture and susceptibility testing, simplified pad test, the Urinary Incontinence-Specific Quality of Life Instrument (I-QOL) and Urogenital Distress Inventory Short Form (UDI-6).
RESULTS


Regarding the objective cure, SIMS was non-inferior to TOT (p < 0.05). However, the same was not found for the subjective cure (p > 0.05). There were no differences in the complication rates (p > 0.05). However, in the TOT group, bladder perforation (2.4%), tape exposure (2.4%) and urinary retention occurred, lasting > 7 days (2.4%). In both groups, there was improvement in quality of life after surgery, without significant differences (p > 0.05).
CONCLUSIONS


The non-inferiority of SIMS in relation to TOT was only demonstrated in the objective cure. There were no significant differences between groups regarding complications and quality of life.",2020,"In both groups, there was improvement in quality of life after surgery, without significant differences (p > 0.05).
","['stress urinary incontinence', 'Stress urinary incontinence (SUI', '105 women with a clinical diagnosis of stress predominant urinary incontinence and urodynamic results demonstrating SUI and absence of detrusor overactivity']","['mini-sling with transobturator sling', 'TOT', 'invasive single-incision mini-sling (SIMS']","['urinary retention', 'anamnesis, physical examination, urinalysis, urine culture and susceptibility testing, simplified pad test, the Urinary Incontinence-Specific Quality of Life Instrument (I-QOL) and Urogenital Distress Inventory Short Form (UDI-6', 'quality of life', 'bladder perforation', 'complication rates', 'complications and quality of life', 'subjective cure', 'objective cure']","[{'cui': 'C0042025', 'cui_str': 'Urinary Stress Incontinence'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C1536696', 'cui_str': 'Overactivity'}]","[{'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0441637', 'cui_str': 'Slinging'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}]","[{'cui': 'C0080274', 'cui_str': 'Urinary Retention'}, {'cui': 'C0021055', 'cui_str': 'Immunological Memory'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0430404', 'cui_str': 'Urine culture (procedure)'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0434133', 'cui_str': 'Perforation of bladder (disorder)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",105.0,0.139802,"In both groups, there was improvement in quality of life after surgery, without significant differences (p > 0.05).
","[{'ForeName': 'Ana P', 'Initials': 'AP', 'LastName': 'Maturana', 'Affiliation': 'Department of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Lauro Gomes, 2000-Vila Sacadura Cabral, Santo André, SP, 09060-650, Brazil. a.matura2@gmail.com.'}, {'ForeName': 'Claudia C', 'Initials': 'CC', 'LastName': 'Palos', 'Affiliation': 'Department of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Lauro Gomes, 2000-Vila Sacadura Cabral, Santo André, SP, 09060-650, Brazil.'}, {'ForeName': 'Frederico R', 'Initials': 'FR', 'LastName': 'Ghersel', 'Affiliation': 'Department of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Lauro Gomes, 2000-Vila Sacadura Cabral, Santo André, SP, 09060-650, Brazil.'}, {'ForeName': 'Cesar E', 'Initials': 'CE', 'LastName': 'Fernandes', 'Affiliation': 'Department of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Lauro Gomes, 2000-Vila Sacadura Cabral, Santo André, SP, 09060-650, Brazil.'}, {'ForeName': 'Emerson', 'Initials': 'E', 'LastName': 'Oliveira', 'Affiliation': 'Department of Urogynecology and Vaginal Surgery within the Discipline of Gynecology, ABC Medical School, Av. Lauro Gomes, 2000-Vila Sacadura Cabral, Santo André, SP, 09060-650, Brazil.'}]",International urogynecology journal,['10.1007/s00192-019-04145-y']
697,31739245,The effect of carotid chemoreceptor inhibition on exercise tolerance in chronic obstructive pulmonary disease: A randomized-controlled crossover trial.,"BACKGROUND


Patients with chronic obstructive pulmonary disease (COPD) have an exaggerated ventilatory response to exercise, contributing to exertional dyspnea and exercise intolerance. We recently demonstrated enhanced activity and sensitivity of the carotid chemoreceptor (CC) in COPD which may alter ventilatory and cardiovascular regulation and negatively affect exercise tolerance. We sought to determine whether CC inhibition improves ventilatory and cardiovascular regulation, dyspnea and exercise tolerance in COPD.
METHODS


Twelve mild-moderate COPD patients (FEV 1  83 ± 15 %predicted) and twelve age- and sex-matched healthy controls completed two time-to-symptom limitation (T LIM ) constant load exercise tests at 75% peak power output with either intravenous saline or low-dose dopamine (2 μg·kg -1 ·min -1 , order randomized) to inhibit the CC. Ventilatory responses were evaluated using expired gas data and dyspnea was evaluated using a modified Borg scale. Inspiratory capacity maneuvers were performed to determine operating lung volumes. Cardiac output was estimated using impedance cardiography and vascular conductance was calculated as cardiac output/mean arterial pressure (MAP).
RESULTS


At a standardized exercise time of 4-min and at T LIM ; ventilation, operating volumes and dyspnea were unaffected by dopamine in COPD patients and controls. In COPD, dopamine decreased MAP and increased vascular conductance at all time points. In controls, dopamine increased vascular conductance at T LIM , while MAP was unaffected.
CONCLUSION


There was no change in time to exhaustion in either group with dopamine. These data suggest that the CC plays a role in cardiovascular regulation during exercise in COPD; however, ventilation, dyspnea and exercise tolerance were unaffected by CC inhibition in COPD patients.",2019,There was no change in time to exhaustion in either group with dopamine.,"['COPD patients', 'chronic obstructive pulmonary disease', 'Patients with chronic obstructive pulmonary disease (COPD', 'COPD', 'Twelve mild-moderate COPD patients (FEV 1  83\u202f±\u202f15 %predicted) and twelve age- and sex-matched healthy controls completed two', 'COPD patients and controls']","['time-to-symptom limitation (T LIM ) constant load exercise tests at 75% peak power output with either intravenous saline or low-dose dopamine', 'CC inhibition', 'carotid chemoreceptor inhibition']","['ventilatory and cardiovascular regulation, dyspnea and exercise tolerance', 'impedance cardiography and vascular conductance', 'ventilation, dyspnea and exercise tolerance', 'vascular conductance', 'Ventilatory responses', 'cardiac output/mean arterial pressure (MAP', 'time to exhaustion', 'Cardiac output', 'exercise tolerance']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0449205', 'cui_str': 'LIM (body structure)'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0007185', 'cui_str': 'Plethysmography, Impedance, Transthoracic'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}]",,0.081874,There was no change in time to exhaustion in either group with dopamine.,"[{'ForeName': 'Devin B', 'Initials': 'DB', 'LastName': 'Phillips', 'Affiliation': 'Division of Pulmonary Medicine, Faculty of Medicine and Dentistry, University of Alberta, Canada; Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Canada.'}, {'ForeName': 'Sophie É', 'Initials': 'SÉ', 'LastName': 'Collins', 'Affiliation': 'Division of Pulmonary Medicine, Faculty of Medicine and Dentistry, University of Alberta, Canada; Faculty of Rehabilitation Medicine, University of Alberta, Canada.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Bryan', 'Affiliation': 'Division of Pulmonary Medicine, Faculty of Medicine and Dentistry, University of Alberta, Canada.'}, {'ForeName': 'Eric Y L', 'Initials': 'EYL', 'LastName': 'Wong', 'Affiliation': 'Division of Pulmonary Medicine, Faculty of Medicine and Dentistry, University of Alberta, Canada.'}, {'ForeName': 'M Sean', 'Initials': 'MS', 'LastName': 'McMurtry', 'Affiliation': 'Division of Cardiology, Faculty of Medicine and Dentistry, University of Alberta, Canada.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhutani', 'Affiliation': 'Division of Pulmonary Medicine, Faculty of Medicine and Dentistry, University of Alberta, Canada.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Stickland', 'Affiliation': 'Division of Pulmonary Medicine, Faculty of Medicine and Dentistry, University of Alberta, Canada; G.F. MacDonald Centre for Lung Health, Covenant Health, Edmonton, Alberta, Canada. Electronic address: michael.stickland@ualberta.ca.'}]",Respiratory medicine,['10.1016/j.rmed.2019.105815']
698,31181186,Randomized Controlled Trial of Motivational Interviewing to Support Breastfeeding Among Appalachian Women.,"OBJECTIVE


To determine the effectiveness of a single session of prenatal motivational interviewing (MI) to enhance breastfeeding outcomes.
DESIGN


A randomized controlled trial with two groups (MI and psychoeducation) with repeated measures: preintervention, postintervention, and at 1 month postpartum.
SETTING


The intervention was conducted at a university-associated clinic, community locations, and participants' homes. Postpartum follow-up was conducted by telephone.
PARTICIPANTS


A total of 81 women with low-risk pregnancies enrolled at 28 to 39 weeks gestation who lived in Appalachia.
METHODS


Participants were randomly assigned to MI or psychoeducation on infant development. Pre- and postintervention outcome measures included intention to breastfeed, confidence in and importance of breastfeeding plan, and breastfeeding attitudes. At 1 month postpartum, participants completed a telephone interview to assess actual breastfeeding initiation, exclusivity, and plans to continue breastfeeding.
RESULTS


At 1 month postpartum, women in the MI group were more likely to report any current breastfeeding than women in the psychoeducation group, regardless of parity, χ 2 (1, N = 79) = 4.30, p = .040, Φ = .233. At the postintervention time point, the MI intervention had a significant effect on improving attitudes about breastfeeding among primiparous women only (p < .05).
CONCLUSION


One session of MI was effective to promote breastfeeding at 1 month postpartum and to enhance positive attitudes toward breastfeeding among primiparous women in Appalachia.",2019,"At the postintervention time point, the MI intervention had a significant effect on improving attitudes about breastfeeding among primiparous women only (p < .05).
","['A total of 81 women with low-risk pregnancies enrolled at 28 to 39\xa0weeks gestation who lived in Appalachia', ""The intervention was conducted at a university-associated clinic, community locations, and participants' homes"", 'Participants', 'Appalachian Women', 'primiparous women in Appalachia']","['MI or psychoeducation', 'prenatal motivational interviewing (MI', 'Motivational Interviewing to Support', 'telephone interview to assess actual breastfeeding initiation, exclusivity, and plans to continue breastfeeding']","['likely to report any current breastfeeding', 'intention to breastfeed, confidence in and importance of breastfeeding plan, and breastfeeding attitudes', 'attitudes about breastfeeding']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0404841', 'cui_str': 'Low risk pregnancy (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0003609', 'cui_str': 'Appalachia'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}]","[{'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}]","[{'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",81.0,0.0787234,"At the postintervention time point, the MI intervention had a significant effect on improving attitudes about breastfeeding among primiparous women only (p < .05).
","[{'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Addicks', 'Affiliation': ''}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'McNeil', 'Affiliation': ''}]","Journal of obstetric, gynecologic, and neonatal nursing : JOGNN",['10.1016/j.jogn.2019.05.003']
699,31760911,Elder sexual abuse and implicit agism: examining the warm-incompetent bias among mock jurors.,"Implicit ageist beliefs about the warmth and incompetence of older adults may influence jurors' perceptions and judgments of an older adult's competence in legal cases hinging on capacity and consent, including elder sexual abuse. However, little is known about the nuances of implicit agism in elder sexual abuse cases, and if it can be attenuated. The current study proposed to address these gaps via a randomized vignette design administered to a community sample of 391 US adults. Mock juror participants evaluated an elder sexual abuse case involving an older married couple, in which the victim had dementia. Results suggest that implicit agism was present among mock jurors, consistent with a warm-incompetence bias, and was predictive of mock jurors' guilt ratings. Age- and dementia-relevant jury instructions and mock juror gender were not found to be predictive of guilt ratings. Implicit agism among jurors should be addressed to reduce the potential for implicit age bias to affect elder sexual abuse cases.",2020,Age- and dementia-relevant jury instructions and mock juror gender were not found to be predictive of guilt ratings.,"['older adults', '391\xa0US adults']",[],"['elder sexual abuse case', 'Elder sexual abuse and implicit agism']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0331055', 'cui_str': 'Elder Plant'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse (event)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",,0.0157601,Age- and dementia-relevant jury instructions and mock juror gender were not found to be predictive of guilt ratings.,"[{'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Syme', 'Affiliation': 'Center on Aging, Kansas State University, Manhattan, New York, USA.'}, {'ForeName': 'Tracy J', 'Initials': 'TJ', 'LastName': 'Cohn', 'Affiliation': 'Department of Psychology, Radford University, Radford, Virginia, USA.'}]",Journal of elder abuse & neglect,['10.1080/08946566.2019.1695696']
700,31167545,Effects of Brief Acceptance and Cognitive Reappraisal Interventions on Experiential Avoidance in Socially Anxious Individuals: A Preliminary Investigation.,"The current study compared the effects of 15-min acceptance-based and cognitive reappraisal-based interventions on experiential avoidance (EA) in socially anxious college students who participated in an experimental public speaking task. Participants were randomly assigned to receive one of the two interventions designed to aid in preparation for a 5-min laboratory-based public speaking task. Results indicated that participants receiving the acceptance-based intervention reported significantly lower levels of EA at the post-public speaking task measurement time, indicating that this brief acceptance-based intervention yielded the proposed mechanism of action in the sample used for this study. These findings highlight the importance of process-based accounts of cognitive-behavioral psychotherapy and shed light on the importance of developing interventions for alleviating social anxiety.",2020,"Results indicated that participants receiving the acceptance-based intervention reported significantly lower levels of EA at the post-public speaking task measurement time, indicating that this brief acceptance-based intervention yielded the proposed mechanism of action in the sample used for this study.","['Socially Anxious Individuals', 'socially anxious college students who participated in an experimental public speaking task']","['Brief Acceptance and Cognitive Reappraisal Interventions', 'two interventions designed to aid in preparation for a 5-min laboratory-based public speaking task', '15-min acceptance-based and cognitive reappraisal-based interventions on experiential avoidance (EA']","['Experiential Avoidance', 'levels of EA']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0198886,"Results indicated that participants receiving the acceptance-based intervention reported significantly lower levels of EA at the post-public speaking task measurement time, indicating that this brief acceptance-based intervention yielded the proposed mechanism of action in the sample used for this study.","[{'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Spencer', 'Affiliation': 'Minnesota State University, Mankato, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Buchanan', 'Affiliation': 'Minnesota State University, Mankato, USA.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Masuda', 'Affiliation': ""University of Hawai'i at Mānoa, Honolulu, USA.""}]",Behavior modification,['10.1177/0145445519854321']
701,25055847,Effects of computer-based stress management training on psychological well-being and work performance in japanese employees: a cluster randomized controlled trial.,"This study evaluated the effectiveness of a computer-based stress management training (SMT) program in improving employees' psychological well-being and work performance. A total of 12 work units (N=263) were randomly assigned to either an intervention group (8 work units, n=142) or to a wait-list control group (4 work units, n=121). All participants were requested to answer online questionnaires assessing psychological well-being as a primary outcome, and coping style, social support, and knowledge about stress management as secondary outcomes at baseline (T0), immediately after the intervention (T1), and 2 months after the intervention (T2). The group × time interaction was tested using a mixed-model repeated measures ANOVA. Results showed a group × time interaction for ""knowledge about stress management"" in the entire sample. Among participants who had more than 3 d of training, a significant group × time interaction was observed for ""problem-solving"" and ""avoidance and suppression"" as well as ""knowledge about stress management."" Our computer-based stress management program was effective for improving knowledge about stress management. It was also effective for improving coping skills in instances where participants had enough time (at least 3 d) to complete all sessions.",2014,"Results showed a group × time interaction for ""knowledge about stress management"" in the entire sample.","['participants who had more than 3 d of training, a significant group\u2005×', 'japanese employees', 'A total of 12 work units (N=263']","[' Our computer-based stress management program', 'intervention group (8 work units, n=142) or to a wait-list control group', 'computer-based stress management training (SMT) program', 'computer-based stress management training']","['time interaction', 'psychological well-being and work performance', 'coping skills', ""employees' psychological well-being and work performance""]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C1286385', 'cui_str': 'Performance at Work'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}]",263.0,0.0194144,"Results showed a group × time interaction for ""knowledge about stress management"" in the entire sample.","[{'ForeName': 'Rino', 'Initials': 'R', 'LastName': 'Umanodan', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Shimazu', 'Affiliation': ''}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Minami', 'Affiliation': ''}, {'ForeName': 'Norito', 'Initials': 'N', 'LastName': 'Kawakami', 'Affiliation': ''}]",Industrial health,[]
702,31165606,"Pain, disability and adherence to home exercises in patients with chronic neck pain: long term effects of phone surveillance. A randomized controlled study.","BACKGROUND


Effectiveness of phone surveillance and other communication technologies in the management of neck pain patients have been evaluated previously only at the suspension of the service.
AIM


To verify whether a phone surveillance program can improve pain, disability, and adherence to home exercises in neck pain patients, and whether the improvement achieved continues to be maintained also after suspension of the support.
DESIGN


This is a randomized controlled study.
SETTING


Outpatients of Rehabilitation Unit.
POPULATION


84 out of 100 outpatients consecutively randomized (by blocks of four) to Phone group (N.=42, performing a 6-month home-based phone surveillance program) or to Control group (N.=42, with the only recommendation to continue exercising at home without phone surveillance) were considered. The home-based phone surveillance program consisted of 12 scheduled phone calls, each performed every fortnight by a nurse-tutor with expertise in rehabilitation for the first six months of the study. At the end of phone surveillance period, Phone patients were encouraged to continue home exercises for a further 6 months period.
METHODS


Pain severity (assessed with Pain VAS), disability (Neck Disability Index), and adherence to exercises performed at home (classified as: ≥5 sessions/week, 2-4 sessions/week, occasional or no sessions) were outcome measures. Pain severity and disability were assessed at entry, at 6 and 12 months, while adherence to exercises was self-reported and recorded at 6 and 12 months. Differences between groups were analyzed with χ2 test, Student's t-test or ANOVA.
RESULTS


At 6 months, Pain VAS (P=0.013) and Neck Disability Index scores (P=0.012) were lower in Phone patients than Controls. At 12 months, Neck Disability Index scores (P=0.026) continued to be lower in Phone patients than Controls. At 6 months, 97.6% of Phone patients and 80.9% of Controls performed rehabilitation at home with a range of 2 to 7 sessions/week; while at 12 months, the respective percentages of Phone and Control patients were 92.9% and 73.8%. Adherence to home exercises was higher in Phone patients than in Controls at 6 (P=0.013) and 12 months (P=0.019).
CONCLUSIONS


In patients with chronic neck pain, the positive effects of phone surveillance on the neck disability and adherence to home exercises still persist 6 months after the suspension of the support.
CLINICAL REHABILITATION IMPACT


This knowledge can be useful for physicians to plan home rehabilitation of neck pain patients.",2020,"At 12 months, Neck Disability Index scores (p=0.026) continued to be lower in Phone patients than Controls.","['patients with chronic neck pain', 'neck pain patients', '84 out of 100 outpatients consecutively randomized (by blocks of four) to Phone group (n=42, performing a', 'Outpatients of Rehabilitation Unit']","['phone surveillance and other communication technologies', '6-month home-based phone surveillance program) or to Control group (n=42, with the only recommendation to continue exercising at home without phone surveillance', 'phone surveillance program']","['Pain VAS', 'pain, disability, and adherence to home exercises', 'Pain severity (assessed with Pain VAS), disability (Neck Disability Index), and adherence to exercises', 'Adherence to home exercises', 'Pain severity and disability', 'Neck Disability Index scores', 'Pain, disability and adherence to home exercises']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}]","[{'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C2959538', 'cui_str': 'Neck disability index score'}]",100.0,0.0343178,"At 12 months, Neck Disability Index scores (p=0.026) continued to be lower in Phone patients than Controls.","[{'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Gialanella', 'Affiliation': 'Operative Unit for Recovery and Functional Rehabilitation of the Institute of Lumezzane, Istituti Clinici Scientifici Maugeri IRCCS, Brescia, Italy - gialanellab@gmail.com.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Comini', 'Affiliation': 'Scientific Direction of the Institute of Lumezzane, Istituti Clinici Scientifici Maugeri IRCCS, Brescia, Italy.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Olivares', 'Affiliation': 'Scientific Direction of the Institute of Lumezzane, Istituti Clinici Scientifici Maugeri IRCCS, Brescia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Gelmini', 'Affiliation': 'Operative Unit for Recovery and Functional Rehabilitation of the Institute of Lumezzane, Istituti Clinici Scientifici Maugeri IRCCS, Brescia, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ubertini', 'Affiliation': 'Operative Unit for Recovery and Functional Rehabilitation of the Institute of Lumezzane, Istituti Clinici Scientifici Maugeri IRCCS, Brescia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Grioni', 'Affiliation': 'Operative Unit for Recovery and Functional Rehabilitation of the Institute of Castel Goffredo of Mantua, Istituti Clinici Scientifici Maugeri IRCCS, Brescia, Italy.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.19.05686-7']
703,31837575,Remote programming: A convenient and cost-effective measure of vagus nerve stimulation for children with epilepsy.,"This study aimed to evaluate the efficacy, adverse events and expense burden of outpatient versus remote programming for vagus nerve stimulation (VNS) in children with epilepsy. A total of 46 children with drug-resistant epilepsy, who underwent VNS at the Pediatric Epilepsy Center, Peking University First Hospital between March 2017 and June 2018, were enrolled into the study. Participants were assigned (non-randomized) into an outpatient programming group or remote programming group (where VNS parameters were adjusted through the internet) by parental choice. The responder rate, expenditure for VNS programming and adverse events were compared between the two groups. The median age at VNS implantation was 5.17 years (3.83-6.71), with the median epileptic course being 3.79 years (2.65-4.90). Twenty-four patients were assigned to the outpatient programming group and 22 were assigned to the remote programming group. Baseline data were comparable between the two groups, with the exception of the remote group having a longer distance between their place of residence and the hospital. The median time from VNS implantation to last follow-up was 1.33 years (1.25-1.75) and 1.46 years (1.17-1.58) in the outpatient and remote groups, respectively. In the outpatient programming group, 15 patients (62.5 %,) were VNS responders and four patients (16.6 %) became seizure-free. In the remote programming group, 16 patients (72.7 %) were VNS responders and four (17.4 %) became seizure-free. Cough and hoarseness were common adverse events in both the outpatient and remote groups (33.3 % vs. 18.2 %). There were no significant differences between the two groups in terms of adverse events. The median cost of each follow-up visit per patient in the outpatient group was 192.4 US dollars ($120.0-$376.5), of which travelling expenses were the major component, followed by accommodation fees, outpatient service fees and indirect costs. Whereas, patients in the remote programming group only needed to pay for the remote programming expense, which totaled 75.8 US dollars per person each time. The efficacy and adverse events were both comparable between the outpatient and remote programming patients. Remote programming was found to be a more cost-effective treatment, especially for patients living further away from centers specializing in epilepsy.",2020,"Remote programming was found to be a more cost-effective treatment, especially for patients living further away from centers specializing in epilepsy.","['children with epilepsy', '46 children with drug-resistant epilepsy, who underwent VNS at the Pediatric Epilepsy Center, Peking University First Hospital between March 2017 and June 2018, were enrolled into the study', 'patients living further away from centers specializing in epilepsy']","['outpatient programming group or remote programming group', 'remote programming for vagus nerve stimulation (VNS']","['adverse events', 'responder rate, expenditure for VNS programming and adverse events', 'efficacy and adverse events', 'median cost', 'Cough and hoarseness', 'median age at VNS implantation', 'median time from VNS implantation', 'median epileptic course']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C1096063', 'cui_str': 'Refractory Epilepsy'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704211', 'cui_str': 'Specialized'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]",46.0,0.0185774,"Remote programming was found to be a more cost-effective treatment, especially for patients living further away from centers specializing in epilepsy.","[{'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Pediatrics, Peking University First Hospital, 100034, China; Pediatric Epilepsy Center, Peking University First Hospital, 100034, China.'}, {'ForeName': 'Taoyun', 'Initials': 'T', 'LastName': 'Ji', 'Affiliation': 'Department of Pediatrics, Peking University First Hospital, 100034, China; Pediatric Epilepsy Center, Peking University First Hospital, 100034, China.'}, {'ForeName': 'Jiayi', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Pediatrics, Peking University First Hospital, 100034, China; Pediatric Epilepsy Center, Peking University First Hospital, 100034, China.'}, {'ForeName': 'Qingzhu', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Pediatric Epilepsy Center, Peking University First Hospital, 100034, China.'}, {'ForeName': 'Yuwu', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Pediatrics, Peking University First Hospital, 100034, China; Pediatric Epilepsy Center, Peking University First Hospital, 100034, China.'}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Cai', 'Affiliation': 'Pediatric Epilepsy Center, Peking University First Hospital, 100034, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Pediatrics, Peking University First Hospital, 100034, China; Pediatric Epilepsy Center, Peking University First Hospital, 100034, China. Electronic address: dryewu@263.net.'}]",Epilepsy research,['10.1016/j.eplepsyres.2019.106246']
704,31172849,Characterizing lymphocyte counts and infection rates with long-term teriflunomide treatment: Pooled analysis of clinical trials.,"BACKGROUND


In Phase 3 studies, teriflunomide reduced relapse rates and disability progression compared with placebo; however, decreases in lymphocyte counts were also observed.
OBJECTIVE


To describe the effect of long-term teriflunomide treatment on lymphocyte counts and infection rates among patients in pooled analyses of Phase 3 core and extension studies.
METHODS


Four randomized trials (TEMSO, TOWER, TENERE, and TOPIC) compared teriflunomide 7 mg or 14 mg treatment with either placebo and/or subcutaneous interferon (IFN) β-1a 44 µg in patients with relapsing forms of multiple sclerosis (MS) (or first clinical episode suggestive of MS in TOPIC).
RESULTS


In 1895, patients ever exposed to teriflunomide, mean (standard deviation) absolute lymphocyte counts declined from Week 0 (1.89 (0.59)) to Week 24 (1.67 (0.52)) and then remained stable thereafter. In the core plus extension studies (up to 10.7 years), 7.3% and 2.2% experienced Grade 1 and Grade 2 lymphopenia, respectively. Infections were reported in 56.9% of patients without lymphopenia, 60.9% with Grade 1 lymphopenia, and 54.8% with Grade 2 lymphopenia. Serious infections occurred in 3.7%, 4.3%, and 7.1%, respectively.
CONCLUSION


Long-term risk of lymphopenia and infections in patients who continue to receive teriflunomide is low, demonstrating a limited impact on adaptive and innate immunity.",2020,"Infections were reported in 56.9% of patients without lymphopenia, 60.9% with Grade 1 lymphopenia, and 54.8% with Grade 2 lymphopenia.","['patients in pooled analyses of Phase 3 core and extension studies', 'patients with relapsing forms of multiple sclerosis (MS) (or first clinical episode suggestive of MS in TOPIC']","['teriflunomide', 'placebo and/or subcutaneous interferon (IFN) β-1a 44\u2009µg', 'placebo', 'long-term teriflunomide']","['relapse rates and disability progression', 'Serious infections', 'lymphocyte counts', 'lymphocyte counts and infection rates', 'Characterizing lymphocyte counts and infection rates', 'Infections']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of (attribute)'}]","[{'cui': 'C1718383', 'cui_str': 'teriflunomide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}]",1895.0,0.111965,"Infections were reported in 56.9% of patients without lymphopenia, 60.9% with Grade 1 lymphopenia, and 54.8% with Grade 2 lymphopenia.","[{'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': 'Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Aaron E', 'Initials': 'AE', 'LastName': 'Miller', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Benamor', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Truffinet', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Poole', 'Affiliation': 'Sanofi, Cambridge, MA, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519851981']
705,31763984,Allogeneic cardiosphere-derived cells for the treatment of heart failure with reduced ejection fraction: the Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells (DYNAMIC) trial.,"AIMS


The DYNAMIC trial assessed the safety and explored the efficacy of multivessel intracoronary infusion of allogeneic cardiosphere-derived cells (CDCs) in patients with heart failure and reduced ejection fraction (HFrEF). Here we report the results of the DYNAMIC trial.
METHODS AND RESULTS


We enrolled 14 patients with EF ≤35% and NYHA Class III-IV despite maximal medical and device-based therapy in this single-centre, open-label trial. Intracoronary catheterisation delivered four escalating doses (totalling 37.5-75 million cells) by sequential non-occlusive technique to all three major coronary arteries. The primary safety endpoint was a composite of post-infusion TIMI flow, ventricular tachycardia/fibrillation, sudden death, major adverse cardiac events or acute myocarditis within 72 hours. Twelve patients were male and EF averaged 23.0% (±4.5%). No primary safety endpoints were observed. Two patients died of HFrEF progression nine and 12 months following infusion. Compared to baseline, there was an improvement in EF (26.8% vs 22.9%, p=0.023) and left ventricular end-systolic volume (139.5 vs 177.8 cm3, p=0.03) at six months. Quality of life (QoL) scores and NYHA class (p=0.006) improved at six months. At 12 months, the improvement in EF and QoL remained significant.
CONCLUSIONS


Global intracoronary infusion of allogeneic CDCs is safe and feasible. The efficacy of allogeneic CDCs in HFrEF needs to be tested in larger randomised trials.",2020,Quality of life (QoL) scores and NYHA class (p=0.006) improved at 6 months.,"['Heart Failure with Reduced Ejection Fraction', '14 patients with EF≤35% and NYHA III-IV despite maximal medical- and device-based therapy in this single-center, open-label trial', 'patients with heart failure and reduced ejection fraction (HFrEF']","['Intracoronary catheterization', 'multivessel intracoronary infusion of allogeneic cardiosphere-derived cells (CDCs', 'allogeneic CDCs', 'Allogeneic Cardiosphere-derived Cells']","['left ventricular end-systolic volume', 'composite of post-infusion TIMI flow, ventricular tachycardia/fibrillation, sudden death, major adverse cardiac events or acute myocarditis within 72 hours', 'EF and QoL', 'EF', 'Quality of life (QoL) scores and NYHA class']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0055295', 'cui_str': 'chenodeoxycholic acid sulfate conjugate'}]","[{'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0042514', 'cui_str': 'Tachycardia, Ventricular'}, {'cui': 'C0232197', 'cui_str': 'Fibrillation (disorder)'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0155686', 'cui_str': 'Acute myocarditis (disorder)'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]",14.0,0.111307,Quality of life (QoL) scores and NYHA class (p=0.006) improved at 6 months.,"[{'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Chakravarty', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Henry', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Kittleson', 'Affiliation': ''}, {'ForeName': 'Joao', 'Initials': 'J', 'LastName': 'Lima', 'Affiliation': ''}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Siegel', 'Affiliation': ''}, {'ForeName': 'Leandro', 'Initials': 'L', 'LastName': 'Slipczuk', 'Affiliation': ''}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Pogoda', 'Affiliation': ''}, {'ForeName': 'Rachel R', 'Initials': 'RR', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Malliaras', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Marbán', 'Affiliation': ''}, {'ForeName': 'Deborah D', 'Initials': 'DD', 'LastName': 'Ascheim', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Marbán', 'Affiliation': ''}, {'ForeName': 'Raj R', 'Initials': 'RR', 'LastName': 'Makkar', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00035']
706,31751853,Baseline blood eosinophil count as a predictor of treatment response to the licensed dose of mepolizumab in severe eosinophilic asthma.,"BACKGROUND


Previous analyses examining the relationship between blood eosinophil count and mepolizumab treatment effects in severe eosinophilic asthma have used a range of doses and administration routes.
METHODS


This post hoc meta-analysis included data from the MENSA (MEA115588/NCT01691521) and MUSCA (200862/NCT02281318) trials. Patients (≥12 years) with severe eosinophilic asthma who experienced ≥2 exacerbations in the prior year received either mepolizumab 100 mg subcutaneously (SC) or 75 mg intravenously, or placebo plus standard of care every 4 weeks. This meta-analysis reports data from patients receiving the licensed dose of mepolizumab (100 mg SC) or placebo only. The primary endpoint was the annual rate of clinically significant exacerbations; secondary endpoints included rate of exacerbations requiring hospitalization/emergency room (ER) visit, proportion of patients with no clinically significant exacerbations, and changes from baseline in forced expiratory volume in 1 s, Asthma Control Questionnaire-5 and St George's Respiratory Questionnaire scores. Analyses were stratified by baseline blood eosinophil count (<150, ≥150, ≥300, ≥400, ≥500, ≥750, ≥1000, ≥150-<300, or ≥300-<500 cells/μL).
RESULTS


Mepolizumab reduced annual clinically significant exacerbation rates by 45%-85%, exacerbations requiring hospitalization/ER visit by 60%-70%, and increased the odds of no clinically significant exacerbations across all eosinophil threshold subgroups versus placebo, and improved all other secondary endpoints in subgroups ≥150 cells/μL. Greater treatment effects with increasing blood eosinophil count were observed.
CONCLUSIONS


Mepolizumab demonstrated consistent clinical benefits in patients with baseline blood eosinophil counts ≥150 cells/μL, confirming the suitability of this cut-off for identifying patients responsive to the licensed mepolizumab dose.",2019,"RESULTS


Mepolizumab reduced annual clinically significant exacerbation rates by 45%-85%, exacerbations requiring hospitalization/ER visit by 60%-70%, and increased the odds of no clinically significant exacerbations across all eosinophil threshold subgroups versus placebo, and improved all other secondary endpoints in subgroups ≥150 cells/μL. Greater treatment effects with increasing blood eosinophil count were observed.
","['severe eosinophilic asthma', 'Patients (≥12 years) with severe eosinophilic asthma who experienced ≥2 exacerbations in the prior year received either']","['placebo', 'mepolizumab 100\u202fmg subcutaneously (SC) or 75\u202fmg intravenously, or placebo', 'mepolizumab', 'Mepolizumab']","['exacerbation rates', 'Baseline blood eosinophil count', 'annual rate of clinically significant exacerbations', 'blood eosinophil count', ""rate of exacerbations requiring hospitalization/emergency room (ER) visit, proportion of patients with no clinically significant exacerbations, and changes from baseline in forced expiratory volume in 1\u202fs, Asthma Control Questionnaire-5 and St George's Respiratory Questionnaire scores""]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0034068', 'cui_str': 'Pulmonary Eosinophilia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4058348', 'cui_str': 'mepolizumab 100 MG [Nucala]'}, {'cui': 'C0969324', 'cui_str': 'mepolizumab'}]","[{'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.435937,"RESULTS


Mepolizumab reduced annual clinically significant exacerbation rates by 45%-85%, exacerbations requiring hospitalization/ER visit by 60%-70%, and increased the odds of no clinically significant exacerbations across all eosinophil threshold subgroups versus placebo, and improved all other secondary endpoints in subgroups ≥150 cells/μL. Greater treatment effects with increasing blood eosinophil count were observed.
","[{'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Albers', 'Affiliation': 'Respiratory Medical Franchise, GSK, Research Triangle Park, NC, USA. Electronic address: frank-c.albers@t-online.de.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Licskai', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, ON, Canada; London Health Sciences, London, ON, Canada. Electronic address: Chris.Licskai@sjhc.london.on.ca.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Chanez', 'Affiliation': 'Unités Mixtes de Recherche INSERM C2VN Center INSERM INRA UMR1062, Aix-Marseille Université, France; Department of Respiratory Diseases and Clinical Investigation Center, Assistance Publique-Hopitaux de Marseille, Hopital Nord, Marseille, France. Electronic address: Pascal.CHANEZ@univ-amu.fr.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Bratton', 'Affiliation': 'Clinical Statistics, GSK, Stockley Park, Uxbridge, UK. Electronic address: daniel.x.bratton@gsk.com.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Bradford', 'Affiliation': 'Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA. Electronic address: eric.s.bradford@gsk.com.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Yancey', 'Affiliation': 'Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA. Electronic address: steve.w.yancey@gsk.com.'}, {'ForeName': 'Namhee', 'Initials': 'N', 'LastName': 'Kwon', 'Affiliation': 'Respiratory Medical Franchise, GSK, Brentford, Middlesex, UK. Electronic address: namhee.n.kwon@gsk.com.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Quirce', 'Affiliation': 'Department of Allergy, Hospital La Paz Institute for Health Research (IdiPAZ), CIBER de Enfermedades Respiratorias CIBERES, Madrid, Spain. Electronic address: squirce@gmail.com.'}]",Respiratory medicine,['10.1016/j.rmed.2019.105806']
707,19590732,"Olanzapine and fluoxetine combination therapy for treatment-resistant depression: review of efficacy, safety, and study design issues.","Treatment-resistant depression (TRD) is a common occurrence in clinical practice. Up to 30% of patients with major depression do not respond to conventional antidepressant treatment, while a significantly greater number of patients experience only partial symptom reduction. Numerous strategies may be applied by the practicing clinician to overcome limitations in the effectiveness of antidepressant monotherapy, including combining drug treatment with evidence-supported psychotherapies, combining antidepressants (combination pharmacotherapy), and combining antidepressants with other non-antidepressant psychotropic medications (augmentation treatment). One such augmentation strategy, the combination of the selective serotonin reuptake inhibitor, fluoxetine (FLX), with the atypical antipsychotic drug, olanzapine (OLZ), is supported by the results of four randomized, double-blind, acute phase studies of patients who had responded inadequately to antidepressant monotherapy. In each study, the FLX/OLZ combination caused rapid reduction in Montgomery-Asberg Depression Rating scale scores, with two of the four studies showing significantly greater improvement than antidepressant monotherapy at study endpoint. Effects of the FLX/OLZ combination were strongest in cases where failure to respond to two antidepressants prior to randomization was established during the current depressive episode. The FLX/OLZ combination was well-tolerated; however, body weight gain and increases in prolactin were greater than that of the antidepressant monotherapy groups, and were comparable to that of OLZ monotherapy. While effective during acute-phase treatment, questions remain regarding the long-term efficacy and safety of FLX/OLZ relative to antidepressant monotherapy and other combination strategies. Efforts aimed at determining the placement of FLX/OLZ among the available options for addressing TRD are limited by lack of comparison and sequential treatment studies. Important aspects of study design and directions for future research are discussed.",2009,"The FLX/OLZ combination was well-tolerated; however, body weight gain and increases in prolactin were greater than that of the antidepressant monotherapy groups, and were comparable to that of OLZ monotherapy.","['treatment-resistant depression', 'patients who had responded inadequately to antidepressant monotherapy']","['FLX/OLZ', 'Olanzapine', 'fluoxetine combination therapy', 'fluoxetine (FLX), with the atypical antipsychotic drug, olanzapine (OLZ']","['body weight gain and increases in prolactin', 'Montgomery-Asberg Depression Rating scale scores', 'number of patients experience only partial symptom reduction']","[{'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C1276996', 'cui_str': 'Atypical antipsychotic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0170667,"The FLX/OLZ combination was well-tolerated; however, body weight gain and increases in prolactin were greater than that of the antidepressant monotherapy groups, and were comparable to that of OLZ monotherapy.","[{'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Bobo', 'Affiliation': 'Department of Psychiatry, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': ''}]",Neuropsychiatric disease and treatment,[]
708,31168845,Curcuminoids plus piperine improve nonalcoholic fatty liver disease: A clinical trial.,"BACKGROUND


Nonalcoholic fatty liver disease (NAFLD) as a prevalent hepatic disease is associated with an increased risk of morbidity and mortality related to the liver and cardiovascular disease (CVD). Lifestyle modification and good metabolic control is the first line of treatment, but not always efficacious in reversing NAFLD pathogenesis. Curcumin is a dietary phytochemical with hepatoprotective activities, though its low bioavailability is considered as a major challenge for clinical applications. Therefore, in this study, in order to improve the bioavailability of curcumin, it was coadministered with piperine and we investigated the effects of this bioavailability-enhanced curcumin on serum hepatic enzymes, lipid profile, and glycemic indices in patients with NAFLD.
METHODS


In this randomized controlled parallel-group trial, 70 subjects with ultrasound-determined NAFLD were randomized to either 500 mg curcuminoids coadministered with 5 mg piperine daily or placebo for 12 weeks. NAFLD severity (on the basis of sonography) and hepatic function was assessed at baseline and at the study end.
RESULTS


Seventy subjects completed the study. Supplementation with curcuminoids plus piperine significantly reduced the hematocrit (P = 0.027), erythrocyte sedimentation rate (P = 0.048) and the serum concentrations of alanine aminotransferase (P = 0.035), aspartate aminotransferase (P = 0.042), alkaline phosphatase (P = 0.004), cholesterol (P < 0.016), low-density lipoprotein cholesterol (P < 0.017), Iron (P = 0.026), and Hemoglobin (P = 0.025) and increased total iron-binding capacity (P = 0.003). However, except albumin, changes in other parameters were not statistically different between groups. In addition, administration of curcuminoids plus piperine significantly improved NAFLD severity (P < 0.001), which was statistically different compared with the placebo group (P = 0.022). Also, the percentage of improved patients was marginally higher in the curcuminoids plus piperine group when compared with the placebo group (P = 0.058).
CONCLUSION


This study suggested beneficial effects of combined curcuminoids and piperine supplementation on disease severity in patients with NAFLD.",2019,"Supplementation with curcuminoids plus piperine significantly reduced the hematocrit (P = 0.027), erythrocyte sedimentation rate (P = 0.048) and the serum concentrations of alanine aminotransferase (P = 0.035), aspartate aminotransferase (P = 0.042), alkaline phosphatase (P = 0.004), cholesterol (P < 0.016), low-density lipoprotein cholesterol (P < 0.017), Iron (P = 0.026), and Hemoglobin (P = 0.025) and increased total iron-binding capacity (P = 0.003).","['Seventy subjects completed the study', '70 subjects with ultrasound-determined NAFLD', 'patients with NAFLD']","['combined curcuminoids and piperine supplementation', '500\u2009mg curcuminoids coadministered with 5\u2009mg piperine daily or placebo', 'placebo', 'Curcuminoids plus piperine']","['hepatic function', 'aspartate aminotransferase', 'Hemoglobin', 'nonalcoholic fatty liver disease', 'serum concentrations of alanine aminotransferase', 'alkaline phosphatase', 'cholesterol', 'low-density lipoprotein cholesterol', 'total iron-binding capacity', 'hematocrit', 'serum hepatic enzymes, lipid profile, and glycemic indices', 'NAFLD severity', 'erythrocyte sedimentation rate']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0071112', 'cui_str': 'piperine'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}]",70.0,0.304112,"Supplementation with curcuminoids plus piperine significantly reduced the hematocrit (P = 0.027), erythrocyte sedimentation rate (P = 0.048) and the serum concentrations of alanine aminotransferase (P = 0.035), aspartate aminotransferase (P = 0.042), alkaline phosphatase (P = 0.004), cholesterol (P < 0.016), low-density lipoprotein cholesterol (P < 0.017), Iron (P = 0.026), and Hemoglobin (P = 0.025) and increased total iron-binding capacity (P = 0.003).","[{'ForeName': 'Yunes', 'Initials': 'Y', 'LastName': 'Panahi', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Valizadegan', 'Affiliation': 'Baqiyatallah Research Center for Gastroenterology and Liver Disease, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nobakht', 'Initials': 'N', 'LastName': 'Ahamdi', 'Affiliation': 'Baqiyatallah Research Center for Gastroenterology and Liver Disease, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Ganjali', 'Affiliation': 'Department of Medical Biotechnology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Muhammed', 'Initials': 'M', 'LastName': 'Majeed', 'Affiliation': 'Sabinsa Corporation, New Jersey.'}, {'ForeName': 'Amirhossein', 'Initials': 'A', 'LastName': 'Sahebkar', 'Affiliation': 'Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Journal of cellular biochemistry,['10.1002/jcb.28877']
709,31169141,Adding a vacuum erection device to regular use of Tadalafil improves penile rehabilitation after posterior urethroplasty.,"This study aimed to evaluate whether adding a vacuum erection device (VED) to regular use of Tadalafil could achieve better penile rehabilitation following posterior urethroplasty for pelvic fracture-related urethral injury (PFUI). Altogether, 78 PFUI patients with erectile dysfunction (ED) after primary posterior urethroplasty were enrolled and divided into two treatment groups: VED combined with Tadalafil (Group 1, n = 36) and Tadalafil only (Group 2, n = 42). Changes in penile length, testosterone level, International Index of Erectile Function-5 (IIEF-5) questionnaire, Quality of Erection Questionnaire (QEQ), and nocturnal penile tumescence (NPT) testing were used to assess erectile function before and after 6 months of ED treatment. Results showed that the addition of VED to regular use of Tadalafil preserved more penile length statistically (0.4 ± 0.9 vs -0.8 ± 0.7 cm, P < 0.01). IIEF-5 score and QEQ score in Group 1 were higher than Group 2 (both P < 0.05). After treatment, 21/36 (58.3%) Group 1 patients and 19/42 (45.2%) Group 2 patients could complete vaginal penetration. Group 1 patients also had markedly improved testosterone levels (P = 0.01). Unexpectedly, there was no significant difference in NPT testing between two therapies. For PFUI patients with ED after posterior urethroplasty, the addition of VED to regular use of Tadalafil could significantly improve their conditions - improving erection and increasing penile length - thus increasing patient satisfaction and confidence in penile rehabilitation.",2019,IIEF-5 score and QEQ score in Group 1 were higher than Group 2 (both P < 0.05).,"['78 PFUI patients with erectile dysfunction (ED) after primary posterior urethroplasty', 'posterior urethroplasty for pelvic fracture-related urethral injury (PFUI', 'after posterior urethroplasty']","['VED combined with Tadalafil', 'Tadalafil', 'vacuum erection device (VED']","['testosterone levels', 'penile length', 'complete vaginal penetration', 'IIEF-5 score and QEQ score', 'penile length, testosterone level, International Index of Erectile Function-5 (IIEF-5) questionnaire, Quality of Erection Questionnaire (QEQ), and nocturnal penile tumescence (NPT) testing', 'penile rehabilitation', 'NPT testing']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0161922', 'cui_str': 'Repair of urethra (procedure)'}, {'cui': 'C0149531', 'cui_str': 'Pelvic fracture'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0403701', 'cui_str': 'Injury of urethra (disorder)'}]","[{'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0556623', 'cui_str': 'Vaginal penetration (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0372464', 'cui_str': 'Nocturnal Penile Tumescence'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]",78.0,0.0395482,IIEF-5 score and QEQ score in Group 1 were higher than Group 2 (both P < 0.05).,"[{'ForeName': 'Dong-Liang', 'Initials': 'DL', 'LastName': 'Zhang', 'Affiliation': ""Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Oriental Institute for Urologic Reconstruction, Shanghai 200233, China.""}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Oriental Institute for Urologic Reconstruction, Shanghai 200233, China.""}, {'ForeName': 'Fei-Xiang', 'Initials': 'FX', 'LastName': 'Wang', 'Affiliation': 'Academy of Forensic Science, Shanghai Key Laboratory of Forensic Medicine, Shanghai 200233, China.'}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Oriental Institute for Urologic Reconstruction, Shanghai 200233, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': ""Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Oriental Institute for Urologic Reconstruction, Shanghai 200233, China.""}, {'ForeName': 'Ze-Yu', 'Initials': 'ZY', 'LastName': 'Wang', 'Affiliation': ""Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Oriental Institute for Urologic Reconstruction, Shanghai 200233, China.""}, {'ForeName': 'Yu-Bo', 'Initials': 'YB', 'LastName': 'Gu', 'Affiliation': ""Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Oriental Institute for Urologic Reconstruction, Shanghai 200233, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': ""Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Oriental Institute for Urologic Reconstruction, Shanghai 200233, China.""}, {'ForeName': 'Lu-Jie', 'Initials': 'LJ', 'LastName': 'Song', 'Affiliation': ""Department of Urology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai Oriental Institute for Urologic Reconstruction, Shanghai 200233, China.""}]",Asian journal of andrology,['10.4103/aja.aja_50_19;']
710,31739276,The impact of internet-delivered cognitive behavioural therapy for health anxiety on cyberchondria.,"Cyberchondria refers to an emotional-behavioural pattern whereby excessive online searches lead to increased anxiety about one's own health status. It has been shown to be associated with health anxiety, however it is unknown whether existing cognitive behavioural therapy (CBT) interventions targeting health anxiety also improve cyberchondria. This study aimed to determine whether internet-delivered cognitive behavioural therapy (iCBT) for severe health anxiety led to improvements in self-reported cyberchondria and whether improvements in cyberchondria were associated with improvements in health anxiety observed during treatment. Methods: We analysed secondary data from a randomised controlled trial (RCT) comparing an iCBT group (n = 41) to an active control group who underwent psychoeducation, monitoring and clinical support (n = 41) in health anxious patients with a DSM-5 diagnosis of Illness Anxiety Disorder and/or Somatic Symptom Disorder. The iCBT group showed a significantly greater reduction in cyberchondria compared to the control group, with large differences at post-treatment on the Cyberchondria Severity Scale Total scale (CSS; Hedges g = 1.09), and the Compulsion, Distress, Excessiveness subscales of the CSS (g's: 0.8-1.13). Mediation analyses showed improvements in health anxiety in the iCBT group were mediated by improvements in all of the CSS subscales, except for the Mistrust subscale. Conclusions: Internet CBT for health anxiety improves cyberchondria.",2020,"The iCBT group showed a significantly greater reduction in cyberchondria compared to the control group, with large differences at post-treatment on the Cyberchondria Severity Scale Total scale (CSS; Hedges g = 1.09), and the Compulsion, Distress, Excessiveness subscales of the CSS (g's: 0.8-1.13).","['health anxious patients with a DSM-5 diagnosis of Illness Anxiety Disorder and/or Somatic Symptom Disorder', 'health anxiety on cyberchondria']","['internet-delivered cognitive behavioural therapy (iCBT', 'cognitive behavioural therapy (CBT) interventions', 'internet-delivered cognitive behavioural therapy', 'active control group who underwent psychoeducation, monitoring and clinical support (n\u202f=\u202f41', 'iCBT']","['Cyberchondria Severity Scale Total scale', 'health anxiety', 'Compulsion, Distress, Excessiveness subscales', 'cyberchondria']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C4064938', 'cui_str': 'Illness anxiety disorder'}, {'cui': 'C4087321', 'cui_str': 'Somatic symptom disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4552535', 'cui_str': 'Cyberchondria'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C4552535', 'cui_str': 'Cyberchondria'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0600104', 'cui_str': 'Compulsive Behavior'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.0557165,"The iCBT group showed a significantly greater reduction in cyberchondria compared to the control group, with large differences at post-treatment on the Cyberchondria Severity Scale Total scale (CSS; Hedges g = 1.09), and the Compulsion, Distress, Excessiveness subscales of the CSS (g's: 0.8-1.13).","[{'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Newby', 'Affiliation': ""School of Psychology, UNSW Sydney, 1302 Mathews Building, Randwick, NSW, 2052, Australia; Clinical Research Unit for Anxiety and Depression (CRUfAD), School of Psychiatry, UNSW Sydney at St Vincent's Hospital, 390 Victoria Street Darlinghurst, NSW, Sydney, 2010, Australia. Electronic address: j.newby@unsw.edu.au.""}, {'ForeName': 'Eoin', 'Initials': 'E', 'LastName': 'McElroy', 'Affiliation': 'Department of Neuroscience, Psychology and Behaviour, University of Leicester, University Road, Leicester, LE1 7RH, UK.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.102150']
711,31868130,Effects of dynamic lycra orthosis as an adjunct to rehabilitation after botulinum toxin-A injection of the upper-limb in adults following stroke: A single-blinded randomized controlled pilot study.,"BACKGROUND


Dynamic lycra splints are proposed to modify hypertonicity due to their characteristics - neutral warmth, circumferential pressure, and creating a low-intensity prolonged stretch on hypertonic muscles - to contribute to increased sensory awareness of the involved limb.
OBJECTIVES


The aim of this study was to investigate the effects of dynamic lycra orthosis as an adjunct to botulinum toxin-A injection and rehabilitation of the upper-limb in adults following stroke.
METHODS


Patients who had suffered a stroke more than three months previously were randomized into two groups: lycra sleeve plus rehabilitation (n = 10) and only-rehabilitation group (n = 10). After botulinum toxin injection, both groups underwent an upper-limb rehabilitation program. The intervention group wore a lycra sleeve for eight hours a day, five days a week for three weeks in addition to the rehabilitation program. Fugl Meyer upper-limb motor score, Motricity index, Modified Ashworth scale, Box and Block test, Stroke Impact Scale and change in touch-detection thresholds of the fingers measured via Semmes-Weinstein monofilaments were assessed by blinded investigators at before treatment, post-treatment (at 3 weeks) and three months post-treatment. This trial is registered with Clinicaltrials.gov, number NCT03546959.
RESULTS


There were no differences between groups in terms of Fugl Meyer upper-limb motor score, Motricity Index, Modified Ashworth scale, Box and Block test, Stroke Impact Scale and change in light touch threshold at any follow-up time points.
CONCLUSIONS


Using lycra splints as an adjunct to an upper-limb rehabilitation program after stroke did not provide additional benefit in spasticity, upper-limb motor function, light touch threshold of fingers or stroke-specific quality-of-life.",2020,"There were no differences between groups in terms of Fugl Meyer upper-limb motor score, Motricity Index, Modified Ashworth scale, Box and Block test, Stroke Impact Scale and change in light touch threshold at any follow-up time points.","['adults following stroke', 'Methods : Patients who had suffered a stroke more than three months previously']","['botulinum toxin-A injection', ' ', 'botulinum toxin injection', 'lycra sleeve plus rehabilitation (n = 10) and only-rehabilitation group', 'botulinum toxin-A injection and rehabilitation', 'Dynamic lycra splints', 'upper-limb rehabilitation program', 'dynamic lycra orthosis', 'lycra sleeve']","['Fugl Meyer upper-limb motor score, Motricity Index, Modified Ashworth scale, Box and Block test, Stroke Impact Scale and change in light touch threshold', 'Fugl Meyer upper-limb motor score, Motricity index, Modified Ashworth scale, Box and Block test, Stroke Impact Scale and change in touch-detection thresholds of the fingers measured via Semmes-Weinstein monofilaments']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}, {'cui': 'C0074939', 'cui_str': 'Spandex'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451322', 'cui_str': 'Motricity index (assessment scale)'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0423553', 'cui_str': 'Light touch, function (observable entity)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0612257,"There were no differences between groups in terms of Fugl Meyer upper-limb motor score, Motricity Index, Modified Ashworth scale, Box and Block test, Stroke Impact Scale and change in light touch threshold at any follow-up time points.","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Giray', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine , İstanbul, Turkey.'}, {'ForeName': 'Kardelen', 'Initials': 'K', 'LastName': 'Gencer Atalay', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine , İstanbul, Turkey.'}, {'ForeName': 'Nurullah', 'Initials': 'N', 'LastName': 'Eren', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine , İstanbul, Turkey.'}, {'ForeName': 'Osman Hakan', 'Initials': 'OH', 'LastName': 'Gündüz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine , İstanbul, Turkey.'}, {'ForeName': 'Evrim', 'Initials': 'E', 'LastName': 'Karadag-Saygi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine , İstanbul, Turkey.'}]",Topics in stroke rehabilitation,['10.1080/10749357.2019.1704371']
712,31374252,Change in Psychotropic Prescribing Patterns Among Youths in Foster Care Associated With a Peer-to-Peer Physician Consultation Program.,"There has been growing concern about the safety and efficacy of psychotropic prescribing practices for children enrolled in Medicaid and in foster care. 1  In response, accreditation organizations and policymakers have developed standards for optimal use of psychotropic medications among children. 2  In addition, federal legislation has prompted states to implement monitoring programs to address quality and safety issues among vulnerable pediatric subpopulations. 3,4  Here, we report findings from an evaluation of Indiana's program for foster youth, which used outlier case review followed by peer-to-peer consultation between prescribing physicians and child and adolescent psychiatrists. We observed clinically and statistically significant reductions in polypharmacy, off-label prescribing, inpatient hospitalizations, health care costs, and related outcomes among youths randomized to an immediate intervention group compared to no improvements in a waitlist control group.",2019,"We observed clinically and statistically significant reductions in polypharmacy, off-label prescribing, inpatient hospitalizations, health care costs, and related outcomes among youths randomized to an immediate intervention group compared to no improvements in a waitlist control group.","['children enrolled in Medicaid and in foster care', 'children', '3,4', 'Youths in Foster Care']",[],"['polypharmacy, off-label prescribing, inpatient hospitalizations, health care costs']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0580718', 'cui_str': 'Foster care procedures (procedure)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]",[],"[{'cui': 'C2922974', 'cui_str': 'Polymedication'}, {'cui': 'C1096117', 'cui_str': 'Off-Label Prescribing'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}]",,0.022105,"We observed clinically and statistically significant reductions in polypharmacy, off-label prescribing, inpatient hospitalizations, health care costs, and related outcomes among youths randomized to an immediate intervention group compared to no improvements in a waitlist control group.","[{'ForeName': 'Brea', 'Initials': 'B', 'LastName': 'Perry', 'Affiliation': 'Indiana University, Bloomington. Electronic address: blperry@indiana.edu.'}, {'ForeName': 'Kelda Harris', 'Initials': 'KH', 'LastName': 'Walsh', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Plawecki', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Jill C', 'Initials': 'JC', 'LastName': 'Fodstad', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Hillary S', 'Initials': 'HS', 'LastName': 'Blake', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Hunt', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Ott', 'Affiliation': 'Purdue University College of Pharmacy, West Lafayette, IN.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rowlison', 'Affiliation': 'Indiana Department of Child Services, Fort Wayne.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'McConnell', 'Affiliation': 'Florida Atlantic University, Boca Raton.'}, {'ForeName': 'Katlyn', 'Initials': 'K', 'LastName': 'Kleimola', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Hulvershorn', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.06.014']
713,30776134,"Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Tolerability of JNJ-61178104, a Novel Tumor Necrosis Factor-Alpha and Interleukin-17A Bispecific Antibody, in Healthy Subjects.","The safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of JNJ-61178104, a novel anti-tumor necrosis factor-alpha (TNFα) and anti-interleukin-17A (IL-17A) bispecific antibody, were investigated in a placebo-controlled, first-in-human study. Healthy subjects (n = 54) received a single dose of JNJ-61178104 by either intravenous infusion (0.1, 0.3, 1, 3, and 10 mg/kg) or subcutaneous injection (1 mg/kg). Blood samples for measurement of serum JNJ-61178104 concentrations, total IL-17A, total TNFα, and detection of antidrug antibodies were collected for up to 16 weeks after dosing and assessed using electrochemiluminescence immunoassays. PK parameters were calculated by noncompartmental analysis and estimated by nonlinear mixed-effects modeling. JNJ-61178104 was generally well tolerated in healthy subjects. For the intravenous cohorts, mean maximum concentration, and area under the concentration-time curve values increased in a dose-proportional manner. Mean clearance ranged from 6.73 to 9.99 mL/day/kg, mean volume of distribution at terminal phase after intravenous administration ranged from 51.0 to 91.9 mL/kg, and mean half-life ranged from 4.3 to 9.7 days following intravenous administration. After a single subcutaneous dose of 1 mg/kg, median time to maximum concentration was 4.0 days, mean bioavailability was 52.0% and mean half-life was 5.3 days. A linear 2-compartment population model with first-order elimination adequately characterized the pharmacokinetics with parameters consistent with noncompartmental analysis estimates. Body weight and antidrug antibodies were significant covariates on JNJ-61178104 clearance. The time to reach mean maximum serum total TNFα and total IL-17A concentrations appeared to be dose dependent across the 0.1 mg/kg to 10 mg/kg IV dose groups. All subjects who received active treatment were antidrug antibody positive after dosing with JNJ-61178104.",2019,The time to reach mean maximum serum total TNFα and total IL-17A concentrations appeared to be dose dependent across the 0.1 mg/kg to 10 mg/kg IV dose groups.,"['Healthy Subjects', 'Healthy subjects (n\xa0=\xa054', 'healthy subjects']",['subcutaneous injection'],"['Mean clearance', 'Blood samples for measurement of serum JNJ-61178104 concentrations, total IL-17A, total TNFα, and detection of antidrug antibodies', 'median time to maximum concentration', 'time to reach mean maximum serum total TNFα and total IL-17A concentrations', 'antidrug antibody positive', 'mean maximum concentration, and area under the concentration-time curve values', 'mean bioavailability', 'PK parameters', 'Body weight and antidrug antibodies', 'safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of JNJ-61178104, a novel anti-tumor necrosis factor-alpha (TNFα) and anti-interleukin-17A (IL-17A) bispecific antibody', 'Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Tolerability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0206492', 'cui_str': 'Bifunctional Antibodies'}]",,0.0411094,The time to reach mean maximum serum total TNFα and total IL-17A concentrations appeared to be dose dependent across the 0.1 mg/kg to 10 mg/kg IV dose groups.,"[{'ForeName': 'Derrick E', 'Initials': 'DE', 'LastName': 'Akpalu', 'Affiliation': 'Clinical Pharmacology & Pharmacometrics, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Frederick', 'Affiliation': 'Immunology Translational Medicine, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Ivo P', 'Initials': 'IP', 'LastName': 'Nnane', 'Affiliation': 'Clinical Pharmacology & Pharmacometrics, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Zhenling', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Clinical Pharmacology & Pharmacometrics, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': 'Immunology Discovery, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Ort', 'Affiliation': 'Immunology Discovery, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Fink', 'Affiliation': 'Biologics Development Sciences, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Dogmanits', 'Affiliation': 'Biologics Development Sciences, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Raible', 'Affiliation': 'Immunology Translational Medicine, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Amarnath', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Clinical Pharmacology & Pharmacometrics, Janssen R&D, Spring House, PA, USA.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Clinical Pharmacology & Pharmacometrics, Janssen R&D, Spring House, PA, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1393']
714,30635222,"Improving quality of the informed consent process: Developing an easy-to-read, multimodal, patient-centered format in a real-world setting.","OBJECTIVE


To develop a patient-centered informed consent and assessment tool written at a 6th grade-level that is multimodal, affordable, transportable, and readily modifiable for protocol updates.
METHODS


This quality improvement initiative was performed in two phases on an actively-recruiting study at a pediatric diabetes clinic. In phase I, 38 volunteers underwent the standard-paper consent process, a comprehension assessment and provided feedback. Using feedback and the structure of the Plan-Do-Study-Act cycle a multimodal consent and assessment were developed. In phase II, volunteers were randomized to the standard (n = 25) or the multimodal consent (n = 25) and all completed the same comprehension assessment via touch-screen tablet. Primary outcomes were comparison of the individual and total comprehension assessment scores.
RESULTS


Total comprehension scores were higher in the multimodal versus the standard consent group (p <  0.001) and on the elements of benefits (p <  0.001), risks (p <  0.001), volunteerism (p <  0.012), results (p <  0.001), confidentiality (p <  0.004) and privacy (p < 0.001).
CONCLUSION


A multimodal consent and assessment presented sequentially on a touch-screen tablet were patient-centered enhancements to standard consent.
PRACTICE IMPLICATIONS


Multimodal standardization of delivery with improved readability may strengthen the informed consent process.",2019,"RESULTS


Total comprehension scores were higher in the multimodal versus the standard consent group (p <  0.001) and on the elements of benefits (p <  0.001), risks (p <  0.001), volunteerism (p <  0.012), results (p <  0.001), confidentiality (p <  0.004) and privacy (p < 0.001).
","['38 volunteers underwent the standard-paper consent process, a comprehension assessment and provided feedback']",['multimodal consent (n\u2009=\u200925) and all completed the same comprehension assessment via touch-screen tablet'],"['Total comprehension scores', 'individual and total comprehension assessment scores', 'confidentiality']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0152054', 'cui_str': 'Therapeutic Touch'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0009669'}]",38.0,0.0261976,"RESULTS


Total comprehension scores were higher in the multimodal versus the standard consent group (p <  0.001) and on the elements of benefits (p <  0.001), risks (p <  0.001), volunteerism (p <  0.012), results (p <  0.001), confidentiality (p <  0.004) and privacy (p < 0.001).
","[{'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Lindsley', 'Affiliation': 'Manager, Coordinating Center and Regulatory Knowledge & Support (RKS), Georgia Clinical &Translational Science Alliance (Georgia CTSA), Emory University, 1599 Clifton Rd NE; Suite 4.355, Atlanta, GA 30322, USA. Electronic address: klindsl@emory.edu.'}]",Patient education and counseling,['10.1016/j.pec.2018.12.022']
715,31757838,Microvascular and Cardiovascular Outcomes According to Renal Function in Patients Treated With Once-Weekly Exenatide: Insights From the EXSCEL Trial.,"OBJECTIVE


To evaluate the impact of once-weekly exenatide (EQW) on microvascular and cardiovascular (CV) outcomes by baseline renal function in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).
RESEARCH DESIGN AND METHODS


Least squares mean difference (LSMD) in estimated glomerular filtration rate (eGFR) from baseline between the EQW and placebo groups was calculated for 13,844 participants. Cox regression models were used to estimate effects by group on incident macroalbuminuria, retinopathy, and major adverse CV events (MACE). Interval-censored time-to-event models estimated effects on renal composite 1 (40% eGFR decline, renal replacement, or renal death) and renal composite 2 (composite 1 variables plus macroalbuminuria).
RESULTS


EQW did not change eGFR significantly (LSMD 0.21 mL/min/1.73 m 2  [95% CI -0.27 to 0.70]). Macroalbuminuria occurred in 2.2% of patients in the EQW group and in 2.5% of those in the placebo group (hazard ratio [HR] 0.87 [95% CI 0.70-1.07]). Neither renal composite was reduced with EQW in unadjusted analyses, but renal composite 2 was reduced after adjustment (HR 0.85 [95% CI 0.74-0.98]). Retinopathy rates did not differ by treatment group or in the HbA 1c -lowering or prior retinopathy subgroups. CV outcomes in those with eGFR <60 mL/min/1.73 m 2  did not differ by group. Those with eGFR ≥60 mL/min/1.73 m 2  had nominal risk reductions for MACE, all-cause mortality, and CV death, but interactions by renal function group were significant for only stroke (HR 0.74 [95% CI 0.58-0.93];  P  for interaction = 0.035) and CV death (HR 1.08 [95% CI 0.85-1.38];  P  for interaction = 0.031).
CONCLUSIONS


EQW had no impact on unadjusted retinopathy or renal outcomes. CV risk was modestly reduced only in those with eGFR ≥60 mL/min/1.73 m 2  in analyses unadjusted for multiplicity.",2020,CV risk was modestly reduced only in those with eGFR ≥60,"['groups was calculated for 13,844 participants']","['placebo', 'EQW', 'exenatide (EQW']","['renal composite 2', 'CV risk', 'unadjusted retinopathy or renal outcomes', 'Microvascular and Cardiovascular Outcomes', 'renal replacement, or renal death', 'renal composite', 'Retinopathy rates', 'CV outcomes', 'CV death', 'Macroalbuminuria', 'nominal risk reductions for MACE, all-cause mortality, and CV death', 'glomerular filtration rate (eGFR', 'microvascular and cardiovascular (CV) outcomes', 'incident macroalbuminuria, retinopathy, and major adverse CV events (MACE']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0167117', 'cui_str': 'exenatide'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035309', 'cui_str': 'Retinal Diseases'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1654921', 'cui_str': 'Macroalbuminuria'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.309193,CV risk was modestly reduced only in those with eGFR ≥60,"[{'ForeName': 'M Angelyn', 'Initials': 'MA', 'LastName': 'Bethel', 'Affiliation': 'Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford, U.K.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Merrill', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Division of Endocrinology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Juliana C', 'Initials': 'JC', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, The Prince of Wales Hospital, Shatin, Hong Kong SAR, China.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""St. Michael's Hospital, University of Toronto, Ontario, Canada.""}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Neli', 'Initials': 'N', 'LastName': 'Jakuboniene', 'Affiliation': 'Department of Endocrinology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Lokhnygina', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Aldo P', 'Initials': 'AP', 'LastName': 'Maggioni', 'Affiliation': 'ANMCO Research Center, Florence, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ohman', 'Affiliation': 'AstraZeneca Research and Development, Gaithersburg, MD.'}, {'ForeName': 'Tsvetalina', 'Initials': 'T', 'LastName': 'Tankova', 'Affiliation': 'Clinical Center of Endocrinology, Medical University, Sofia, Bulgaria.'}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Bakris', 'Affiliation': 'Comprehensive Hypertension Center, The University of Chicago Medicine, Chicago, IL.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, Oxford, U.K. rury.holman@dtu.ox.ac.uk.'}]",Diabetes care,['10.2337/dc19-1065']
716,30926571,Home Visiting and Antenatal Depression Affect the Quality of Mother and Child Interactions in South Africa.,"OBJECTIVE


To examine whether maternal depressed mood at birth moderated the protective effect of a home-visiting intervention on the quality of caregiving for children growing up in a low- and middle-income country.
METHOD


Almost all pregnant mothers in 24 Cape Town neighborhoods were recruited into a cluster randomized controlled trial matched by neighborhoods to the Philani home-visiting condition (HVC) or the standard care condition (SC). At 3 years after birth, the quality of mother-child interactions between HVC and SC mothers with and without antenatal depressed mood was assessed in a representative subset by rating videotaped observations of mother-child interactions on 10 dimensions of caregiving.
RESULTS


As predicted, maternal depressed mood at birth moderated the effect of the HVC on the quality of mother-child interactions. Among nondepressed mothers, mothers and their children in the HVC scored significantly higher on 5 of the 10 dimensions of the maternal-child interaction scale than mothers in the SC: mothers exhibited more maternal sensitivity, talked more, had more harmonious interactions, and had children who paid more attention and exhibited more positive affect. However, being in the HVC did not significantly affect the mother-child interaction scores among mothers with depressed mood. Among HVC children, those with mothers with depressed mood showed significantly less positive affect and talked less with their mothers than children with nondepressed mothers. SC children with mothers with depressed mood were more responsive and paid attention to their mothers than children with nondepressed mothers.
CONCLUSION


Home visiting resulted in a better quality of caregiving for mothers without depressive symptoms. Future interventions need to specifically target maternal depression and positive mother-child interactions.
CLINICAL TRIAL REGISTRATION INFORMATION


Mentor Mothers: A Sustainable Family Intervention in South African Townships; https://clinicaltrials.gov; NCT00972699; Philani Home-based Nutrition Intervention Program; https://clinicaltrials.gov; NCT00995592.",2019,"SC children with mothers with depressed mood were more responsive and paid attention to their mothers than children with nondepressed mothers.
","['South Africa', 'pregnant mothers in 24 Cape Town neighborhoods', 'children growing up in a low- and middle-income country', 'Mentor Mothers', 'SC children with mothers with depressed mood', 'mothers without depressive symptoms']","['HVC', 'neighborhoods to the Philani home-visiting condition (HVC) or the standard care condition (SC', 'home-visiting intervention']","['maternal sensitivity', 'quality of mother-child interactions', 'quality of caregiving', 'maternal-child interaction scale', 'Quality of Mother and Child Interactions', 'mother-child interaction scores']","[{'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]","[{'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0026590', 'cui_str': 'Mother-Child Relationship'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0396728,"SC children with mothers with depressed mood were more responsive and paid attention to their mothers than children with nondepressed mothers.
","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Christodoulou', 'Affiliation': 'Semel Institute, University of California-Los Angeles. Electronic address: jchristodoulou@mednet.ucla.edu.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Rotheram-Borus', 'Affiliation': 'Semel Institute, University of California-Los Angeles.'}, {'ForeName': 'Alexandra K', 'Initials': 'AK', 'LastName': 'Bradley', 'Affiliation': 'Institute for Life Course Health Research, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tomlinson', 'Affiliation': 'Institute for Life Course Health Research, Stellenbosch University, Stellenbosch, South Africa; School of Nursing and Midwifery, Queens University, Belfast, UK.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.03.016']
717,31148412,Effects of Food and Gender on Pharmacokinetics of Rosuvastatin in a Chinese Population Based on 4 Bioequivalence Studies.,"The effects of food and gender on the pharmacokinetics of rosuvastatin in healthy Chinese subjects were investigated from 4 bioequivalence studies. These studies were designed as randomized, open-label, and 2-period crossover in both fasting and fed states. A total of 204 subjects were enrolled, 134 men and 70 women. These subjects received a single oral 10-mg dose of rosuvastatin with a 7-day washout between 2 periods. The plasma concentrations were determined using a validated liquid chromatography tandem mass spectrometry method, and pharmacokinetic parameters were calculated by noncompartmental methods. Compared with the fasting condition, administration after a high-fat and high-calorie meal resulted in an approximately 40% reduction of rosuvastatin exposure and a near 50% decrease in absorption rate. Moreover, the apparent clearance was significantly greater in the fed state than that in the fasting state. It was noted that the adverse events incidence is increased by approximately 30% in the fasting state; however, no serious adverse events were observed. Additionally, small differences in pharmacokinetic characteristics were found between male and female subjects. Food effect might be considered for optimal effectiveness and safety of rosuvastatin therapy.",2020,"Moreover, the apparent clearance was significantly greater in the fed state than that in the fasting state.","['204 subjects were enrolled, 134 men and 70 women', 'healthy Chinese subjects', 'male and female subjects']","['Rosuvastatin', 'rosuvastatin']","['absorption rate', 'plasma concentrations', 'apparent clearance', 'adverse events incidence']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",204.0,0.020955,"Moreover, the apparent clearance was significantly greater in the fed state than that in the fasting state.","[{'ForeName': 'Jinliang', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Honggang', 'Initials': 'H', 'LastName': 'Lou', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Shao', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Yichao', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Zourong', 'Initials': 'Z', 'LastName': 'Ruan', 'Affiliation': 'Center of Clinical Pharmacology, the Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, Zhejiang, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.706']
718,31749018,Randomized controlled trial on the efficacy of a multilevel non-pharmacologic intervention in older adults with subjective memory decline: design and baseline findings of the E.Mu.N.I. study.,"BACKGROUND


Alzheimer's Disease (AD) is a multifactorial disorder driven by genetic and modifiable lifestyle risk factors. Lifestyle primary prevention initiatives may reduce the prevalence and incidence of dementia in older adults.
OBJECTIVES


The E.Mu.N.I study is a randomized controlled trial investigating the effect of multilevel non-pharmacologic interventions on cognitive performances (primary outcome) and structural and vascular brain MRI markers (secondary outcome), as well as markers of brain functional connectivity change (exploratory outcome), in older adults with subjective memory decline (SMD). Here, we present the study design and the baseline features of the sample.
METHODS


Cognitively intact older adults with SMD, enrolled between February 2016 and June 2017, were randomly assigned to one of the 3 interventions for 1 year: Active Control Intervention (ACI), i.e., educational lessons; Partial Intervention (PI), i.e., homotaurine administration (100 mg/die) and lessons on the Mediterranean diet; Multilevel Intervention (MI), i.e., PI plus computerized cognitive training and physical exercise training.
RESULTS


One-hundred and twenty-eight eligible participants were enrolled (66% female; age: 68 ± 5 years). Eighty-two percent of the sample was composed of volunteers with SMD from the community. Participants were randomly allocated to the interventions as follows: ACI (N = 40), PI (N = 44), MI (N = 44). No significant differences among groups emerged on socio-demographic, clinical-neuropsychological variables and MRI markers at baseline.
CONCLUSIONS


The outcomes obtained from the E.Mu.N.I. study will clarify the efficacy of multilevel non-pharmacologic interventions on cognitive and neuroimaging markers in SMD individuals. This is a crucial step forward for the development of cost-effective non-pharmacologic primary prevention initiatives for AD.",2020,"No significant differences among groups emerged on socio-demographic, clinical-neuropsychological variables and MRI markers at baseline.
","['Cognitively intact older adults with SMD, enrolled between February 2016 and June 2017', 'older adults with subjective memory decline', 'SMD individuals', 'One-hundred and twenty-eight eligible participants were enrolled (66% female; age: 68\u2009±\u20095\xa0years', 'older adults', 'older adults with subjective memory decline (SMD', 'Eighty-two percent of the sample was composed of volunteers with SMD from the community']","['Active Control Intervention (ACI), i.e., educational lessons; Partial Intervention (PI), i.e., homotaurine administration (100\xa0mg/die) and lessons on the Mediterranean diet; Multilevel Intervention (MI), i.e., PI plus computerized cognitive training and physical exercise training', 'multilevel non-pharmacologic interventions', 'multilevel non-pharmacologic intervention']","['socio-demographic, clinical-neuropsychological variables and MRI markers', 'cognitive performances']","[{'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0062961', 'cui_str': 'tramiprosate'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C1138412', 'cui_str': 'Diet, Mediterranean'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",128.0,0.0989114,"No significant differences among groups emerged on socio-demographic, clinical-neuropsychological variables and MRI markers at baseline.
","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Rolandi', 'Affiliation': ""Laboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Dodich', 'Affiliation': 'NIMTlab, Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Galluzzi', 'Affiliation': ""Laboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy.""}, {'ForeName': 'Clarissa', 'Initials': 'C', 'LastName': 'Ferrari', 'Affiliation': 'Statistics Service, IRCCS Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Mandelli', 'Affiliation': 'Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Ribaldi', 'Affiliation': ""Laboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy.""}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Munaretto', 'Affiliation': ""Laboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ambrosi', 'Affiliation': 'Department of Diagnostic Imaging, Neuroradiology Unit, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Gasparotti', 'Affiliation': 'Department of Diagnostic Imaging, Neuroradiology Unit, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Violi', 'Affiliation': 'Millennium Sport and Fitness, 25124, Brescia, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Canessa', 'Affiliation': 'NEtS Center, Scuola Universitaria Superiore IUSS Pavia, 27100, Pavia, Italy.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Iannaccone', 'Affiliation': 'Department of Clinical Neuroscience, San Raffaele Turro Hospital, 20132, Milan, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Marcone', 'Affiliation': 'Department of Clinical Neuroscience, San Raffaele Turro Hospital, 20132, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Falini', 'Affiliation': 'Division of Neuroscience, Department of Neuroradiology and CERMAC, San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Hampel', 'Affiliation': ""Alzheimer Precision Medicine (APM), Établissements Publics à Caractère Scientifique et Technologique (E.P.S.T.), AP-HP, Pitié-Salpêtrière Hospital, Sorbonne University Clinical Research Group (GRC n°21), Boulevard de l'hôpital, 75013, Paris, France.""}, {'ForeName': 'Giovanni B', 'Initials': 'GB', 'LastName': 'Frisoni', 'Affiliation': ""Laboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy.""}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cerami', 'Affiliation': 'Cognitive Neuroscience Laboratory, IRCCS ICS Maugeri, 27100, Pavia, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Cavedo', 'Affiliation': ""Laboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, 25125, Brescia, Italy. enrica.cavedo@gmail.com.""}]",Aging clinical and experimental research,['10.1007/s40520-019-01403-3']
719,31748427,Changeover Trial of Febuxostat and Topiroxostat for Hyperuricemia with Cardiovascular Disease: Sub-Analysis for Chronic Kidney Disease (TROFEO CKD Trial).,"BACKGROUND


The TROFEO trial demonstrated that febuxostat causes greater and more rapid reduction of serum uric acid (s-UA) than topiroxostat. We compared these drugs in patients with chronic kidney disease (CKD) by sub-analysis of the TROFEO trial.
METHODS


This sub-analysis targeted patients with an estimated glomerular filtration rate (eGFR) ≤60 mL/min/1.73 m 2 . The primary endpoint was the s-UA level. Secondary endpoints included creatinine, eGFR, urinary albumin, cystatin-C, oxidized low-density lipoprotein (Ox-LDL), eicosapentaenoic acid/arachidonic acid ratio, lipid biomarkers, high-sensitivity C-reactive protein, and B-type natriuretic peptide (BNP).
RESULTS


There was no significant difference of s-UA between the two groups either before or after treatment. However, s-UA did not exceed 6.0 mg/dL in febuxostat group during the study period, but it exceeded this level in seven patients from topiroxostat group, with the number being significantly higher in topiroxostat group. Serum creatinine (s-Cr) and eGFR were significantly better after 6 months of febuxostat treatment compared with topiroxostat Cystatin-C was significantly lower after 6 months of febuxostat treatment compared with topiroxostat. The Ox-LDL was significantly lower after 3 and 6 months of febuxostat treatment compared with topiroxostat.
CONCLUSION


Febuxostat had stronger renoprotective and antioxidant effects than topiroxostat in patients with hyperuricemia and CKD.",2020,"The Ox-LDL was significantly lower after 3 and 6 months of febuxostat treatment compared with topiroxostat.
","['patients with an estimated glomerular filtration rate (eGFR) ≤60', 'Hyperuricemia with Cardiovascular Disease', 'patients with hyperuricemia and CKD', 'patients with chronic kidney disease (CKD) by sub-analysis of the TROFEO trial']","['febuxostat', 'Febuxostat', 'Febuxostat and Topiroxostat']","['s-UA', 'renoprotective and antioxidant effects', 'Serum creatinine (s-Cr) and eGFR', 'Ox-LDL', 'creatinine, eGFR, urinary albumin, cystatin-C, oxidized low-density lipoprotein (Ox-LDL), eicosapentaenoic acid/arachidonic acid ratio, lipid biomarkers, high-sensitivity C-reactive protein, and B-type natriuretic peptide (BNP', 's-UA level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3811844'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C4049065', 'cui_str': 'topiroxostat'}]","[{'cui': 'C3179302', 'cui_str': 'Anti-Oxidant Effects'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0348035', 'cui_str': 'oxidized low density lipoprotein'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic Acid'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.121033,"The Ox-LDL was significantly lower after 3 and 6 months of febuxostat treatment compared with topiroxostat.
","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Sezai', 'Affiliation': 'Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Unosawa', 'Affiliation': 'Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Taoka', 'Affiliation': 'Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Osaka', 'Affiliation': 'Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hisakuni', 'Initials': 'H', 'LastName': 'Sekino', 'Affiliation': 'Department of Cardiovascular Surgery, Sekino Hospital, Tokyo, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Tanaka', 'Affiliation': 'Department of Cardiovascular Surgery, Nihon University School of Medicine, Tokyo, Japan.'}]",Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia,['10.5761/atcs.oa.19-00162']
720,31414959,Influence of dietary inorganic nitrate on blood pressure and vascular function in hypertension: prospective implications for adjunctive treatment.,"Dietary inorganic nitrate (nitrate) is a promising adjunctive treatment to reduce blood pressure and improve vascular function in hypertension. However, it remains unknown if the efficacy of nitrate is dependent upon an elevated blood pressure or altered by medication in patients with hypertension. Therefore, blood pressure and vascular function, measured by passive leg movement (PLM) and flow-mediated dilation (FMD), were assessed following 3 days of placebo (nitrate-free beetroot juice) and nitrate (nitrate-rich beetroot juice) administration in 13 patients (age: 53 ± 12 yr) with hypertension taking antihypertensive medications ( study 1 ) and in 14 patients (49 ± 13 yr) with hypertension not taking antihypertensive medications ( study 2 ). In  study 1 , plasma nitrite concentration was greater for nitrate than placebo (341 ± 118 vs. 308 ± 123 nmol/L,  P  < 0.05), yet blood pressure and vascular function were unaltered. In  study 2 , plasma nitrite concentration was greater for nitrate than placebo (340 ± 102 vs. 295 ± 93 nmol/L,  P  < 0.01). Systolic (136 ± 16 vs. 141 ± 19 mmHg), diastolic (84 ± 13 vs. 88 ± 12 mmHg), and mean (101 ± 12 vs. 106 ± 13 mmHg) blood pressures were lower ( P  < 0.05), whereas the PLM change in leg vascular conductance (6.0 ± 3.0 vs. 5.1 ± 2.6 mL·min -1 ·mmHg -1 ) and FMD (6.1 ± 2.4% vs. 4.1 ± 2.7%) were greater ( P  < 0.05) for nitrate than placebo. The changes in systolic blood pressure ( r  = -0.60) and FMD ( r  = -0.48) induced by nitrate were inversely correlated ( P  < 0.05) to the respective baseline values obtained in the placebo condition. Thus, the efficacy of nitrate to improve blood pressure and vascular function in hypertension appears to be dependent on the degree of blood pressure elevation and vascular dysfunction and not antihypertensive medication status, per se. NEW & NOTEWORTHY  Dietary nitrate (nitrate) is a promising intervention to improve blood pressure and vascular function in hypertension. We demonstrate that these beneficial effects of nitrate are inversely related to the baseline value in a continuous manner with no distinction between antihypertensive medication status. Thus, the efficacy of nitrate to improve blood pressure and vascular function in hypertension appears to be dependent on the degree of blood pressure elevation and vascular dysfunction and not antihypertensive mediation status.",2019,"In Study 1, plasma nitrite concentration was greater for Nitrate than Placebo (341±118 vs. 308±123 nmol/l,p<0.05), yet blood pressure or vascular function were unaltered.","['13 patients (age:53±12 y) with hypertension ta king antihypertensive medications (Study 1) and in 14 patients (49±13 y) with hypertension not taking antihypertensive medications (Study 2', 'patients with hypertension', 'Hypertension']","['Dietary Inorganic Nitrate', 'Placebo', 'Dietary inorganic nitrate (Nitrate', 'Placebo (nitrate-free beetroot juice) and Nitrate (nitrate-rich beetroot juice']","['Systolic', 'blood pressure or vascular function', 'PLM change in leg vascular conductance', 'blood pressure and vascular function', 'plasma nitrite concentration', 'blood pressure and vascular function, measured by passive leg movement (PLM) and flow-mediated dilation (FMD', 'systolic blood pressure (r=-0.60) and FMD (r=-0.48) induced by Nitrate', 'FMD', 'blood pressure', 'blood pressures', 'Blood Pressure and Vascular Function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0427757', 'cui_str': 'Dipstick test of nitrite concentration'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4517461', 'cui_str': '0.48'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}]",,0.0526688,"In Study 1, plasma nitrite concentration was greater for Nitrate than Placebo (341±118 vs. 308±123 nmol/l,p<0.05), yet blood pressure or vascular function were unaltered.","[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Broxterman', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah.'}, {'ForeName': 'D Taylor', 'Initials': 'DT', 'LastName': 'La Salle', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Van R', 'Initials': 'VR', 'LastName': 'Reese', 'Affiliation': 'Department of Internal Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Russell S', 'Initials': 'RS', 'LastName': 'Richardson', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah.'}, {'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Trinity', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Salt Lake City Veterans Affairs Medical Center, Salt Lake City, Utah.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00371.2019']
721,31749412,Myocardial protection technique structured on cardiac mass.,"OBJECTIVE


Myocardial protection is crucial in cardiac surgery: quantification is often difficult as there is a significant mismatch between body weight and heart weight as per geometric remodeling. This study has the objective to compare two groups of patients on the administration of myocardial protection in valvular pathologies: the first group has indexed the administration with left ventricular mass index; the second has indexed it on the body weight or on the body surface area. The primary endpoint of double-blind case-control study is to detect the difference in incidence in terms of post-operative low cardiac output syndrome.
METHODS


A single-center double-blind case-control study in a specialized regional tertiary cardiac surgery center in Italy. Between March 2017 and September 2018, 200 adults (100 per Group A vs. Group B) were scheduled for elective procedures: Group A (50 aortic valve replacement-50 mitral valve repair in minimally invasive cardiac surgery) used blood cardioplegic solution with Saint Thomas I solution, with calculation of left ventricular mass index with echocardiographic measures (Formula Group A); Group B (50 aortic valve replacement-50 mitral valve repair in minimally invasive cardiac surgery) used blood cardioplegic solution with Saint Thomas I solution, with calculation indexed on the body surface area, Du Bois Method (Formula Group B).
RESULTS


A statistically significant difference was found for Student's t-test in patients who used myocardial indexed protection on left ventricular mass index versus control: aortic valve replacement procedures in aortic valve stenosis-ejection fraction (24 hours, p-value = 0.046), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.043), and infusion of epinephrine after cardiopulmonary bypass (p-value = 0.033); aortic valve replacement procedures in aortic valve insufficiency-ejection fraction (24 hours, p-value = 0.044), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.046), and infusion of Epinephrine after cardiopulmonary bypass (p-value = 0.029). No statistically significant differences in patients undergoing mitral valve repair surgery.
CONCLUSION


The study group in the aortic valve surgery that administered myocardial protection indexed for the left ventricular mass index and showed a statistically significant lower incidence for post-operative low cardiac output syndrome compared to the control group.",2020,"A statistically significant difference was found for Student's t-test in patients who used myocardial indexed protection on left ventricular mass index versus control: aortic valve replacement procedures in aortic valve stenosis-ejection fraction (24 hours, p-value = 0.046), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.043), and infusion of epinephrine after cardiopulmonary bypass (p-value = 0.033); aortic valve replacement procedures in aortic valve insufficiency-ejection fraction (24 hours, p-value = 0.044), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.046), and infusion of Epinephrine after cardiopulmonary bypass (p-value = 0.029).","['patients undergoing mitral valve repair surgery', 'specialized regional tertiary cardiac surgery center in Italy', 'Between March 2017 and September 2018, 200 adults (100 per Group A vs. Group B) were scheduled for']","['elective procedures: Group A (50 aortic valve replacement-50 mitral valve repair in minimally invasive cardiac surgery) used blood cardioplegic solution with Saint Thomas I solution, with calculation of left ventricular mass index with echocardiographic measures (Formula Group A); Group B (50 aortic valve', 'Epinephrine', 'epinephrine', 'replacement-50 mitral valve repair in minimally invasive cardiac surgery']","['incidence in terms of post-operative low cardiac output syndrome', 'stroke volume shift']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0396849', 'cui_str': 'Repair of mitral valve (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0747973', 'cui_str': 'Elective procedure'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0396849', 'cui_str': 'Repair of mitral valve (procedure)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0005768'}, {'cui': 'C0007200', 'cui_str': 'Cardioplegic Solutions'}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0003501', 'cui_str': 'Aortic Valve'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0600177', 'cui_str': 'Low Cardiac Output Syndrome'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}]",200.0,0.0343474,"A statistically significant difference was found for Student's t-test in patients who used myocardial indexed protection on left ventricular mass index versus control: aortic valve replacement procedures in aortic valve stenosis-ejection fraction (24 hours, p-value = 0.046), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.043), and infusion of epinephrine after cardiopulmonary bypass (p-value = 0.033); aortic valve replacement procedures in aortic valve insufficiency-ejection fraction (24 hours, p-value = 0.044), TnT (24 hours, p-value = 0.047), stroke volume shift (24 hours, p-value = 0.046), and infusion of Epinephrine after cardiopulmonary bypass (p-value = 0.029).","[{'ForeName': 'Ignazio', 'Initials': 'I', 'LastName': 'Condello', 'Affiliation': 'Department of Cardiovascular Surgery, Anthea Hospital, GVM Care & Research, Bari, Italy.'}, {'ForeName': 'Patrizio', 'Initials': 'P', 'LastName': 'Lancellotti', 'Affiliation': 'Department of Cardiology, University of Liège, Heart Valve Clinic, CHU Sart Tilman, Liège, Belgium.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Speziale', 'Affiliation': 'Department of Cardiovascular Surgery, Anthea Hospital, GVM Care & Research, Bari, Italy.'}]",Perfusion,['10.1177/0267659119886717']
722,31748884,Laparoscopic Major Hepatectomy: Do Not Underestimate the Impact of Specimen Extraction Site.,"BACKGROUND


In laparoscopic major hepatectomy, analysis of outcomes according to specimen extraction site remains poorly described. The aim was to compare postoperative outcomes according to specimen extraction site.
METHODS


From 2000 to 2017, all laparoscopic major hepatectomies were reviewed and postoperative outcomes were analyzed according to specimen extraction site: subcostal (Group 1), midline (Group 2), or suprapubic (Group 3) incision.
RESULTS


Among 163 patients, 15 (9.2%) belonged to Group 1, 49 (30.1%) in Group 2, and 99 (60.7%) in Group 3. The proportion of right-sided, left-sided, or central hepatectomies, mortality, and overall and severe complications were comparable between groups. Group 1 had larger tumors (61 vs. 38 vs. 47 mm; P = 0.014), higher operative time (338 vs. 282 vs. 260 min; P < 0.008), higher adjacent organ resection rate (46.6 vs. 16.3 vs. 7.1%; P < 0.001), and tended to increase pulmonary complications (40.0 vs. 12.2 vs. 18.2%; P = 0.064). In Group 2, a previous midline incision scar was more frequently used for specimen extraction site (65.3 vs. 26.6 and 30.3%, Group 1 and 3; P < 0.001). Postoperative incisional hernia was observed in 16.4% (n = 23) and was more frequent in Group 2 (26.6 vs. 6.6% and 10.1%, Group 1 and Group 3; P = 0.030). Finally, Group 2 (HR 2.63, 95% CI 1.41-3.53; P = 0.032) was the only independent predictive factor of postoperative incisional hernia.
CONCLUSIONS


While using a previous incision makes sense, the increased risk of postoperative incisional hernia after midline incision promotes the suprapubic incision.",2020,"Postoperative incisional hernia was observed in 16.4% (n = 23) and was more frequent in Group 2 (26.6 vs. 6.6% and 10.1%, Group 1 and Group 3; P = 0.030).","['From 2000 to 2017, all laparoscopic major hepatectomies']","['suprapubic (Group 3) incision', 'Laparoscopic Major Hepatectomy']","['pulmonary complications', 'higher adjacent organ resection rate', 'higher operative time', 'Postoperative incisional hernia', 'midline incision scar', 'risk of postoperative incisional hernia', 'proportion of right-sided, left-sided, or central hepatectomies, mortality, and overall and severe complications']","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}]","[{'cui': 'C0205498', 'cui_str': 'Suprapubic approach (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}]","[{'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0267716', 'cui_str': 'Postoperative Hernia'}, {'cui': 'C0456276', 'cui_str': 'Midline incision (procedure)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0443246', 'cui_str': 'Left sided (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",163.0,0.0809945,"Postoperative incisional hernia was observed in 16.4% (n = 23) and was more frequent in Group 2 (26.6 vs. 6.6% and 10.1%, Group 1 and Group 3; P = 0.030).","[{'ForeName': 'Théophile', 'Initials': 'T', 'LastName': 'Guilbaud', 'Affiliation': 'Department of Digestive, Oncological and Metabolic Surgery, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France. theo.guilbaud@gmail.com.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Feretti', 'Affiliation': 'Department of Digestive, Oncological and Metabolic Surgery, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.'}, {'ForeName': 'Waclaw', 'Initials': 'W', 'LastName': 'Holowko', 'Affiliation': 'Department of Digestive, Oncological and Metabolic Surgery, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.'}, {'ForeName': 'Giovanni Maria', 'Initials': 'GM', 'LastName': 'Garbarino', 'Affiliation': 'Department of Digestive, Oncological and Metabolic Surgery, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.'}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Marchese', 'Affiliation': 'Department of Digestive, Oncological and Metabolic Surgery, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Sarran', 'Affiliation': 'Department of Radiology and Medical Imaging, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Beaussier', 'Affiliation': 'Department of Anesthesiology, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.'}, {'ForeName': 'Brice', 'Initials': 'B', 'LastName': 'Gayet', 'Affiliation': 'Department of Digestive, Oncological and Metabolic Surgery, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fuks', 'Affiliation': 'Department of Digestive, Oncological and Metabolic Surgery, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014, Paris, France.'}]",World journal of surgery,['10.1007/s00268-019-05285-4']
723,31753612,Evaluation of a novel low-cost laparoscopic training model for core laparoscopic skills.,"The study involves the testing of a novel laparoscopic training model by surgeons of various levels of experience.
BACKGROUND


There has been an increasing requirement for low-cost simulation. Our aim was to evaluate the construct validity of a low-cost model for teaching core laparoscopic skills.
METHODS


The Double-Glove model was made from 2 latex gloves, one placed in the other. The inner glove was filled with water and 3 ovals were drawn on the outer glove. Participants were required to dissect the middle oval out without perforating the inner glove or leaving the line border of the middle oval. The task was assessed using a previously validated scoring system (minimum -120; maximum 80).
RESULTS


Ninety-five participants completed the task: 40 novices, 45 intermediates, and 10 experts. The model revealed statistical significance between the three groups. Experts scored higher than novices (58/80 vs 11.7/80; p < 0.0001) and intermediates (58/80 vs 29.1/80; p = 0.0004), and intermediates scored higher than novices (29.1/80 vs 11.7/80; p = 0.014). Novices took more time to complete the task compared to intermediates (10 min vs 7.87 min; p < 0.0001) and experts (10 min vs 6.98 min; p < 0.0001). No correlation between time taken and score obtained was seen (r = -0.06, r = 0.01, r = -0.2 for novice, intermediate, and expert groups).
CONCLUSION


By differentiating between groups of variable experience, the model demonstrated construct validity. It offers an inexpensive model that can be utilized in low-cost laparoscopic simulation.
TYPE OF STUDY


Study of a diagnostic test.
LEVEL OF EVIDENCE


II.",2020,"Experts scored higher than novices (58/80 vs 11.7/80; p < 0.0001) and intermediates (58/80 vs 29.1/80; p = 0.0004), and intermediates scored higher than novices (29.1/80 vs 11.7/80; p = 0.014).","['Participants were required to dissect the middle oval out without perforating the inner glove or leaving the line border of the middle oval', 'core laparoscopic skills', 'by surgeons of various levels of experience', 'Ninety-five participants completed the task: 40 novices, 45 intermediates, and 10 experts']","['novel laparoscopic training model', 'novel low-cost laparoscopic training model']",[],"[{'cui': 'C0205239', 'cui_str': 'Dissecting (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",[],95.0,0.074831,"Experts scored higher than novices (58/80 vs 11.7/80; p < 0.0001) and intermediates (58/80 vs 29.1/80; p = 0.0004), and intermediates scored higher than novices (29.1/80 vs 11.7/80; p = 0.014).","[{'ForeName': 'Damir', 'Initials': 'D', 'LastName': 'Ljuhar', 'Affiliation': ""Department of Paediatric Surgery, Monash Children's Hospital, Clayton, Victoria 3168, Melbourne, Australia; Departments of Paediatrics & Surgery, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia; Department of Surgical Simulation, Monash Children's Hospital, Clayton, Victoria 3168, Melbourne, Australia.""}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Pacilli', 'Affiliation': ""Department of Paediatric Surgery, Monash Children's Hospital, Clayton, Victoria 3168, Melbourne, Australia; Departments of Paediatrics & Surgery, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.""}, {'ForeName': 'Ramesh Mark', 'Initials': 'RM', 'LastName': 'Nataraja', 'Affiliation': ""Department of Paediatric Surgery, Monash Children's Hospital, Clayton, Victoria 3168, Melbourne, Australia; Departments of Paediatrics & Surgery, School of Clinical Sciences, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia; Department of Surgical Simulation, Monash Children's Hospital, Clayton, Victoria 3168, Melbourne, Australia. Electronic address: ram.nataraja@monashhealth.org.""}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2019.09.020']
724,31119822,Exploring compassionate attributes and skills among individuals participating in compassion-focused therapy for enhancing well-being.,"OBJECTIVES


The conceptual approach of compassion underlying compassion-focused therapy (CFT) is based on theoretical rather than empirical grounds. The aim of the present study was to seek empirical support for components of compassion as outlined in the theoretical model underpinning CFT, and to explore which components, if any, matter most for improving well-being.
DESIGN


A sequential exploratory mixed methods design was employed.
METHODS


Alongside a randomized controlled trial (RCT), we systematically examined 625 emails sent by 87 RCT participants to five counsellors during the course of a well-being enhancing CFT self-help intervention, to identify theoretically based compassionate attributes and skills. Next, in a quantitative analysis, we compared participants who did and did not show clinically relevant improvement on well-being with regard to the occurrence of compassionate attributes and skills.
RESULTS


Although the theoretical model of compassion integral to CFT was largely supported by the emails, it was slightly simplified so as to better fit the data. The adjusted model comprises five compassionate attributes (i.e., care for well-being, sensitivity, empathy, distress tolerance, and common humanity) and four compassionate skills (i.e., compassionate attention, reasoning, behaviour, and feeling/sensation). Three illustrative cases are presented to contribute to a better understanding of fundamental components of compassion. Quantitative analyses indicate that participants showing clinically relevant improvement on well-being expressed significantly more compassionate feeling/sensation compared to those who did not.
CONCLUSIONS


We found preliminary evidence for the conceptualization of compassion underlying CFT. Compassionate feeling/sensation bears particular interest when well-being is the intended outcome of CFT.
PRACTITIONER POINTS


Individuals participating in compassion-focused therapy for enhancing well-being experience a wide range of compassionate attributes and skills. Compassion-focused therapy may instigate well-being if a client is able to experience compassionate feeling/sensation.",2020,"Quantitative analyses indicate that participants showing clinically relevant improvement on well-being expressed significantly more compassionate feeling/sensation compared to those who did not.
","['625 emails sent by 87 RCT participants to five counsellors during the course of a well-being enhancing CFT self-help intervention, to identify theoretically based compassionate attributes and skills', 'individuals participating in compassion-focused therapy for enhancing well-being']",['compassion underlying compassion-focused therapy (CFT'],['compassionate feeling/sensation'],"[{'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449234', 'cui_str': 'Attribute (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}]",,0.0446649,"Quantitative analyses indicate that participants showing clinically relevant improvement on well-being expressed significantly more compassionate feeling/sensation compared to those who did not.
","[{'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Sommers-Spijkerman', 'Affiliation': 'Centre for eHealth and Well-being Research, Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Teuntje R', 'Initials': 'TR', 'LastName': 'Elfrink', 'Affiliation': 'Centre for eHealth and Well-being Research, Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Constance H C', 'Initials': 'CHC', 'LastName': 'Drossaert', 'Affiliation': 'Centre for eHealth and Well-being Research, Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Karlein M G', 'Initials': 'KMG', 'LastName': 'Schreurs', 'Affiliation': 'Centre for eHealth and Well-being Research, Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.'}, {'ForeName': 'Ernst T', 'Initials': 'ET', 'LastName': 'Bohlmeijer', 'Affiliation': 'Centre for eHealth and Well-being Research, Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.'}]",Psychology and psychotherapy,['10.1111/papt.12235']
725,31120504,Vitamin D and UV exposure in construction workers-a randomized control trial using text messaging to promote positive behaviours.,"BACKGROUND


The aim of this study was to determine whether a text messaging intervention (supported by a smartphone application) would be effective in the promotion of sun-safe behaviours. Both excessive and insufficient exposure to ultra-violet (UV) radiation were considered.
METHODS


A randomized control crossover trial was conducted. 112 participants from nine sites in the United Kingdom contributed to the study. There were three intervention waves, two in winter (Vitamin D-focussed) and one in summer (UV exposure-focussed). Stages of Change, Standard Erythemal (UV) Dose and assayed blood samples (Vitamin D) were employed to evaluate the effectiveness throughout the 21-day data collection periods.
RESULTS


The intervention was effective in promoting positive progression in Stages of Change for Vitamin D; and this in turn was predictive of increased Vitamin D levels in participants. More limited positive findings were found with respect to UV exposure. Overall, for those in the Intervention, Vitamin D levels were significantly predicted to increase during both of the winter data collection waves.
CONCLUSIONS


Interventions of this type are recommended to promote healthy Vitamin-D levels in construction workers.",2020,"Overall, for those in the Intervention, Vitamin D levels were significantly predicted to increase during both of the winter data collection waves.
",['112 participants from nine sites in the United Kingdom contributed to the study'],"['Vitamin D and UV exposure', 'text messaging intervention', 'ultra-violet (UV) radiation']","['Vitamin D levels', 'Stages of Change, Standard Erythemal (UV) Dose and assayed blood samples (Vitamin D']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C1532472', 'cui_str': 'Ultraviolet'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",112.0,0.0971483,"Overall, for those in the Intervention, Vitamin D levels were significantly predicted to increase during both of the winter data collection waves.
","[{'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Lansdown', 'Affiliation': 'Heriot-Watt University, Edinburgh, EH14 4AS, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cowan', 'Affiliation': 'Heriot-Watt University, Edinburgh, EH14 4AS, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nioi', 'Affiliation': 'Heriot-Watt University, Edinburgh, EH14 4AS, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cowie', 'Affiliation': 'Institute of Occupational Medicine, Edinburgh, EH14 4AP, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wendelboe-Nelson', 'Affiliation': 'Heriot-Watt University, Edinburgh, EH14 4AS, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rashid', 'Affiliation': 'Institute of Occupational Medicine, Edinburgh, EH14 4AP, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ritchie', 'Affiliation': 'Institute of Occupational Medicine, Edinburgh, EH14 4AP, UK.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Cherrie', 'Affiliation': 'Heriot-Watt University, Edinburgh, EH14 4AS, UK.'}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdz056']
726,31744314,How does MobileMums work? Mediators of a physical activity intervention.,"Objectives:  To establish which Social Cognitive Theory constructs mediated effects of the MobileMums (MMP) program on increased duration and frequency of moderate-vigorous physical activity (MVPA) in women with young children (<5 years).  Methods:  This secondary data analysis is from a community-based randomised controlled trial. Over 12 weeks, intervention participants received a minimum of 52 individually tailored text messages, one face-to-face and one telephone-delivered session with a trained behavioural counsellor. Participants identified a support person who also received 12 weeks of individually tailored text messages. Control participants received minimal intervention contact. Data were collected pre- and post-program. Five potential mediators were assessed: barrier self-efficacy, goal setting skills, outcome expectancies, perceived environmental opportunity for physical activity and social support for physical activity.  Results:  Improvements in MVPA frequency were mediated by improvements in barrier self-efficacy, goal setting skills, outcome expectancies and perceived social support. Improvements in MVPA duration resulting from the MMP were mediated by improvements in women's barrier self-efficacy and goal setting skills.  Conclusions:  MMP improved targeted theoretical constructs and this led to changes in women's MVPA. These findings are valuable for refinement and translation of the MMP and for further research to create theory- and evidence-based physical activity behaviour change programs for women with young children.",2020,"Improvements in MVPA frequency were mediated by improvements in barrier self-efficacy, goal setting skills, outcome expectancies and perceived social support.","['women with young children', 'women with young children (<5\u2009years']","['MobileMums (MMP) program', 'minimum of 52 individually tailored text messages, one face-to-face and one telephone-delivered session with a trained behavioural counsellor', 'physical activity intervention', 'minimal intervention contact']","['barrier self-efficacy, goal setting skills, outcome expectancies and perceived social support', 'MVPA frequency', 'duration and frequency of moderate-vigorous physical activity (MVPA', 'barrier self-efficacy, goal setting skills, outcome expectancies, perceived environmental opportunity for physical activity and social support for physical activity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0037438'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",52.0,0.054575,"Improvements in MVPA frequency were mediated by improvements in barrier self-efficacy, goal setting skills, outcome expectancies and perceived social support.","[{'ForeName': 'Brianna S', 'Initials': 'BS', 'LastName': 'Fjeldsoe', 'Affiliation': 'Faculty of Medicine, School of Public Health, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Yvette D', 'Initials': 'YD', 'LastName': 'Miller', 'Affiliation': 'Faculty of Health, School of Public Health and Social Work, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Samantha J', 'Initials': 'SJ', 'LastName': 'Prosser', 'Affiliation': 'Faculty of Health, School of Public Health and Social Work, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Alison L', 'Initials': 'AL', 'LastName': 'Marshall', 'Affiliation': 'Faculty of Health, School of Public Health and Social Work, Queensland University of Technology, Brisbane, Australia.'}]",Psychology & health,['10.1080/08870446.2019.1687698']
727,31707732,Acute lower leg hot water immersion protects macrovascular dilator function following ischaemia-reperfusion injury in humans.,"NEW FINDINGS


• What is the central question of this study? What is the effect of lower leg hot water immersion on vascular ischaemia-reperfusion injury induced in the arm of young healthy humans? • What is the main finding and its importance? Lower leg hot water immersion successfully protects against vascular ischaemia-reperfusion injury in humans. This raises the possibility that targeted heating of the lower legs may be an alternative therapeutic approach to whole-body heating that is equally efficacious at protecting against vascular ischaemia-reperfusion injury.
ABSTRACT


Reperfusion that follows a period of ischaemia paradoxically reduces vasodilator function in humans and contributes to the tissue damage associated with an ischaemic event. Acute whole-body hot water immersion protects against vascular ischaemia-reperfusion (I-R) injury in young healthy humans. However, the effect of acute lower leg heating on I-R injury is unclear. Therefore, the purpose of this study was to test the hypothesis that, compared with thermoneutral control immersion, acute lower leg hot water immersion would prevent the decrease in macro- and microvascular dilator functions following I-R injury in young healthy humans. Ten young healthy subjects (5 female) immersed their lower legs into a circulated water bath for 60 min under two randomized conditions: (1) thermoneutral control immersion (∼33°C) and (2) hot water immersion (∼42°C). Macrovascular (brachial artery flow-mediated dilatation) and microvascular (forearm reactive hyperaemia) dilator functions were assessed using Doppler ultrasound at three time points: (1) pre-immersion, (2) 60 min post-immersion, and (3) post-I/R (20 min of arm ischaemia followed by 20 min of reperfusion). Ischaemia-reperfusion injury reduced macrovascular dilator function following control immersion (pre-immersion 6.0 ± 2.1% vs. post-I/R 3.6 ± 2.1%; P < 0.05), but was well-maintained with prior hot water immersion (pre-immersion 5.8 ± 2.1% vs. post-I/R 5.3 ± 2.1%; P = 0.8). Microvascular dilator function did not differ between conditions or across time. Taken together, acute lower leg hot water immersion prevents the decrease in macrovascular dilator function that occurs following I-R injury in young healthy humans.",2020,Macrovascular (brachial artery flow-mediated dilatation) and microvascular (forearm reactive hyperaemia) dilator functions were assessed using Doppler ultrasound at three time points: 1) pre-immersion; 2) 60 min post-immersion; 3) post-I/R (20 min of arm ischaemia followed by 20 min of reperfusion).,"['Ten young healthy subjects (5 female', 'young healthy humans', 'Ischaemia-Reperfusion Injury in Humans']","['Leg Hot Water Immersion', 'thermoneutral control immersion (∼33°C); 2) hot water immersion (∼42°C', 'lower leg hot water immersion']","['Macrovascular (brachial artery flow-mediated dilatation) and microvascular (forearm reactive hyperaemia) dilator functions', 'macro- and microvascular dilator functions', 'Microvascular dilator function', 'macrovascular dilator function']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-Reperfusion Injury'}]","[{'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0337023', 'cui_str': 'Hot water (substance)'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140621', 'cui_str': 'Leg'}]","[{'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0180431', 'cui_str': 'Dilator, device (physical object)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",10.0,0.0252533,Macrovascular (brachial artery flow-mediated dilatation) and microvascular (forearm reactive hyperaemia) dilator functions were assessed using Doppler ultrasound at three time points: 1) pre-immersion; 2) 60 min post-immersion; 3) post-I/R (20 min of arm ischaemia followed by 20 min of reperfusion).,"[{'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Engelland', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, Fort Worth, TX, USA.'}, {'ForeName': 'Holden W', 'Initials': 'HW', 'LastName': 'Hemingway', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, Fort Worth, TX, USA.'}, {'ForeName': 'Olivia G', 'Initials': 'OG', 'LastName': 'Tomasco', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, Fort Worth, TX, USA.'}, {'ForeName': 'Albert H', 'Initials': 'AH', 'LastName': 'Olivencia-Yurvati', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, Fort Worth, TX, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Romero', 'Affiliation': 'Human Vascular Physiology Laboratory, Department of Physiology and Anatomy, University of North Texas Health Science Center, Fort Worth, TX, USA.'}]",Experimental physiology,['10.1113/EP088154']
728,30859428,Conservative Treatment in Diverticulitis Patients with Pericolic Extraluminal Air and the Role of Antibiotic Treatment.,"BACKGROUND


Recently published studies advocate a conservative approach with observation and antibiotic treatment in diverticulitis patients with pericolic air on computed tomography (CT). The primary aim of this study was to assess the clinical course of initially conservatively treated diverticulitis patients with isolated pericolic air and to identify risk factors for conservative treatment failure. The secondary aim was to assess the outcome of non-antibiotic treatment.
METHODS


Patient data from a retrospective cohort study on risk factors for complicated diverticulitis were combined with data from the DIABOLO trial, a randomised controlled trial comparing non-antibiotic with antibiotic treatment in patients with uncomplicated diverticulitis. The present study identified all patients with Hinchey 1A diverticulitis with isolated pericolic air on CT. Pericolic air was defined as air located < 5 cm from the affected segment of colon. The primary outcome was failure of conservative management which was defined as need for percutaneous abscess drainage or emergency surgery within 30 days after presentation. A multivariable logistic regression of clinical, radiological and laboratorial parameters with respect to treatment failure was performed.
RESULTS


A total of 109 patients were included in the study. Fifty-two (48%) patients were treated with antibiotics. Nine (8%) patients failed conservative management, seven (13%) in the antibiotic treatment group and two (4%) in the non-antibiotic group (p = 0.083). Only (increased) CRP level at presentation was an independent predictor for treatment failure.
CONCLUSIONS


Conservative treatment in diverticulitis patients with isolated pericolic air is a suitable treatment strategy. Moreover, non-antibiotic treatment might be reasonable in selected patients.",2019,The primary outcome was failure of conservative management which was defined as need for percutaneous abscess drainage or emergency surgery within 30 days after presentation.,"['diverticulitis patients with pericolic air on computed tomography (CT', 'patients with uncomplicated diverticulitis', 'patients with Hinchey 1A diverticulitis with isolated pericolic air on CT', 'Diverticulitis Patients with Pericolic Extraluminal Air and the Role of Antibiotic Treatment', 'initially conservatively treated diverticulitis patients with isolated pericolic air and to identify risk factors for conservative treatment failure', 'Patient data from a retrospective cohort study on risk factors for complicated diverticulitis', 'A total of 109 patients were included in the study']","['antibiotic treatment', 'antibiotics']","['CRP level', 'failure of conservative management which was defined as need for percutaneous abscess drainage or emergency surgery']","[{'cui': 'C0012813', 'cui_str': 'Diverticulitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1720688', 'cui_str': 'As needed for'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0344096', 'cui_str': 'Drainage of abscess (procedure)'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",109.0,0.054334,The primary outcome was failure of conservative management which was defined as need for percutaneous abscess drainage or emergency surgery within 30 days after presentation.,"[{'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Bolkenstein', 'Affiliation': 'University of Twente, 5, Drienerlolaan, 7522, NB, Enschede, The Netherlands. he.bolkenstein@meandermc.nl.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'van Dijk', 'Affiliation': 'Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'E C J', 'Initials': 'ECJ', 'LastName': 'Consten', 'Affiliation': 'Department of Surgery, Meander Medisch Centrum, 3800, BM, Amersfoort, The Netherlands.'}, {'ForeName': 'B G F', 'Initials': 'BGF', 'LastName': 'Heggelman', 'Affiliation': 'Department of Radiology, Meander Medical Centre, Amersfoort, The Netherlands.'}, {'ForeName': 'C M A', 'Initials': 'CMA', 'LastName': 'Hoeks', 'Affiliation': 'Department of Radiology, Meander Medical Centre, Amersfoort, The Netherlands.'}, {'ForeName': 'I A M J', 'Initials': 'IAMJ', 'LastName': 'Broeders', 'Affiliation': 'Department of Surgery, Meander Medical Centre, Amersfoort, The Netherlands.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Boermeester', 'Affiliation': 'Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'W A', 'Initials': 'WA', 'LastName': 'Draaisma', 'Affiliation': ""Department of Surgery, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.""}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-019-04153-9']
729,31140565,A randomized controlled trial of azithromycin and sulphadoxine-pyrimethamine as prophylaxis against malaria in pregnancy among human immunodeficiency virus-positive women.,"BACKGROUND


Malaria and human immunodeficiency virus (HIV) infections in pregnancy are important and major contributing factors to maternal morbidity and mortality in sub-Saharan Africa. Prevention of malaria in HIV-positive pregnant woman will reduce the burden of malaria-HIV comorbidity. The objective of this study was to compare effects and safety of azithromycin (AZ) with sulphadoxine-pyrimethamine (SP) for intermittent preventive therapy for malaria in HIV-positive pregnant women.
METHODS


We performed a randomized, controlled, open-label pregnancy trial of 140 HIV-positive pregnant patients attending antenatal clinics at the University College Hospital and Adeoyo Maternity Teaching Hospital, Ibadan, Nigeria. Participants were enrolled from a gestational age of 16 weeks and randomized to receive AZ or SP. The primary outcome was peripheral parasitaemia at delivery. Secondary outcomes were drug tolerability, foetal outcome and birthweight. The χ2 test (or Fisher's exact test, as appropriate) and Student's t test were used in the per-protocol analysis. The level of statistical significance was p<0.05.
RESULTS


A total of 123 participants (87.9%) completed the study: 60 participants received AZ and 63 received SP. The incidence of malaria parasitaemia at delivery in the AZ group was 6 (10.0%), compared with 7 (11.1%) in the SP group (relative risk 0.89 [95% confidence interval 0.28 to 2.82], p=0.84). Placental parasitization was demonstrated in 1 (1.6%) participant in the SP group compared with 3 (5.0%) in the AZ group (p=0.36).
CONCLUSIONS


The findings suggest that AZ is comparable to SP in malaria prevention and safety in HIV-positive pregnant women.",2019,"Placental parasitization was demonstrated in 1 (1.6%) participant in the SP group compared with 3 (5.0%) in the AZ group (p=0.36).
","['A total of 123 participants (87.9%) completed the study: 60 participants received', '140 HIV-positive pregnant patients attending antenatal clinics at the University College Hospital and Adeoyo Maternity Teaching Hospital, Ibadan, Nigeria', 'HIV-positive pregnant woman', 'HIV-positive pregnant women', 'Participants were enrolled from a gestational age of 16 weeks and randomized to receive', 'human immunodeficiency virus-positive women']","['azithromycin (AZ) with sulphadoxine-pyrimethamine (SP', 'AZ and 63 received SP', 'AZ', 'azithromycin and sulphadoxine-pyrimethamine', 'AZ or SP']","['Placental parasitization', 'burden of malaria-HIV comorbidity', 'drug tolerability, foetal outcome and birthweight', 'peripheral parasitaemia at delivery', 'incidence of malaria parasitaemia at delivery']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0700599', 'cui_str': 'Pyrimethamine / Sulfadoxine'}]","[{'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",140.0,0.280571,"Placental parasitization was demonstrated in 1 (1.6%) participant in the SP group compared with 3 (5.0%) in the AZ group (p=0.36).
","[{'ForeName': 'Oriyomi', 'Initials': 'O', 'LastName': 'Akinyotu', 'Affiliation': 'Department of Obstetrics and Gynaecology, University College Hospital, Ibadan, Oyo State, Nigeria.'}, {'ForeName': 'Folasade', 'Initials': 'F', 'LastName': 'Bello', 'Affiliation': 'Department of Obstetrics and Gynaecology, College of Medicine, University of Ibadan, Ibadan, Oyo State, Nigeria.'}, {'ForeName': 'Rukiyat', 'Initials': 'R', 'LastName': 'Abdus-Salam', 'Affiliation': 'Department of Obstetrics and Gynaecology, College of Medicine, University of Ibadan, Ibadan, Oyo State, Nigeria.'}, {'ForeName': 'Ayodele', 'Initials': 'A', 'LastName': 'Arowojolu', 'Affiliation': 'Department of Obstetrics and Gynaecology, College of Medicine, University of Ibadan, Ibadan, Oyo State, Nigeria.'}]",Transactions of the Royal Society of Tropical Medicine and Hygiene,['10.1093/trstmh/trz028']
730,31104005,The effects of Mulligan's mobilization with movement technique in patients with lateral epicondylitis.,"BACKGROUND


Lateral epicondylitis (LE) is a common problem of the arm. Mulligan has proposed the use of mobilization with movement for LE.
OBJECTIVES


To investigate the effects of Mulligan's mobilization with movement (MWM) in LE.
METHODS


Forty patients were included in the study and randomly assigned to group 1 (n= 20), who received MWM, exercise and cold therapy, or group 2 (n= 20), who received exercise and cold therapy. The sessions were conducted five times a week for two weeks. All measures were conducted at baseline, after treatment, at 1st and 3rd months follow-ups. Mann-Whitney U test, a visual analogue scale (VAS) for pain intensity, Patient-rated Tennis Elbow Evaluation (PRTEE) Questionnaire for pain intensity and functional disability and a dynamometer for hand grip strength were applied.
RESULTS


VAS activity pain significantly decreased in group 1 after treatment (p= 0.001), at the 1st (p< 0.001) and 3rd months (p= 0.040). There was a significant decrease in VAS night pain in group 1 (p= 0.024), and a significant increase in pain-free grip strength (p= 0.002) after treatment. PRTEE-Pain scores decreased in group 1 after treatment (p< 0.001), 1st (p< 0.001) and 3rd months (p= 0.001).
CONCLUSIONS


MWM plus exercise and cold therapy is a safe and effective alternative with positive effects on elbow pain, functional capacity, and pain-free, maximum grip strength.",2020,"RESULTS


VAS activity pain significantly decreased in group 1 after treatment (p= 0.001), at the 1st (p< 0.001) and 3rd months (p= 0.040).","['patients with lateral epicondylitis', 'Forty patients were included in the study and randomly assigned to group 1 (n= 20), who received']","[""Mulligan's mobilization with movement technique"", 'MWM, exercise and cold therapy', 'exercise and cold therapy', ""Mulligan's mobilization with movement (MWM"", 'MWM plus exercise and cold therapy']","['PRTEE-Pain scores', 'VAS activity pain', 'VAS night pain', 'pain-free grip strength', 'elbow pain, functional capacity, and pain-free, maximum grip strength', 'visual analogue scale (VAS) for pain intensity, Patient-rated Tennis Elbow Evaluation (PRTEE) Questionnaire for pain intensity and functional disability and a dynamometer for hand grip strength']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039516', 'cui_str': 'Lateral Epicondylitis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}]","[{'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010412', 'cui_str': 'Cold Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234255', 'cui_str': 'Night pain (finding)'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0239266', 'cui_str': 'Pain in elbow (finding)'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039516', 'cui_str': 'Lateral Epicondylitis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}]",40.0,0.0933873,"RESULTS


VAS activity pain significantly decreased in group 1 after treatment (p= 0.001), at the 1st (p< 0.001) and 3rd months (p= 0.040).","[{'ForeName': 'Aycan Cakmak', 'Initials': 'AC', 'LastName': 'Reyhan', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul Bilgi University, Turkey.'}, {'ForeName': 'Dilsad', 'Initials': 'D', 'LastName': 'Sindel', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Faculty of Medicine, Istanbul University, Turkey.'}, {'ForeName': 'Elif Elcin', 'Initials': 'EE', 'LastName': 'Dereli', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Istanbul Bilgi University, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181135']
731,31104006,Effect of early enteral nutrition in elderly patients with hip fracture during the perioperative period.,"OBJECTIVE


This study aimed to assess the effects of early enteral nutrition (EN) in elderly patients with hip fracture.
METHODS


The patients were classified into two groups (with and without EN). We compared the pre- and postoperative albumin (ALB) and inflammatory marker levels of each group and the time spent in bed and quality of life 3 months after surgery between the two groups.
RESULTS


The pre- and postoperative IL-6 levels of the experimental group (61.68 ± 51.80 pg/L) were lower than those of the control group (233.11 ± 206.31 pg/L) (P< 0.001). The experimental group spent a shorter period of time in bed (38.75 ± 14.26 days) in comparison to the control group (99.71 ± 56.87 days) (P< 0.001). Quality of life was better in the experimental group than in the control group (P< 0.001).
CONCLUSIONS


Early EN reduced the increment of postoperative IL-6 levels and improved healing postoperatively.",2020,"Quality of life was better in the experimental group than in the control group (P< 0.001).
","['elderly patients with hip fracture', 'elderly patients with hip fracture during the perioperative period']","['early enteral nutrition', 'early enteral nutrition (EN']","['pre- and postoperative albumin (ALB) and inflammatory marker levels', 'postoperative IL-6 levels', 'pre- and postoperative IL-6 levels', 'Quality of life']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0034380'}]",,0.0429085,"Quality of life was better in the experimental group than in the control group (P< 0.001).
","[{'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': ""Department of Clinical Nutrition, People's Hospital of Yuxi City, Yuxi, Yunnan 653100, China.""}, {'ForeName': 'Jing-Hua', 'Initials': 'JH', 'LastName': 'Lu', 'Affiliation': ""Department of Orthopeadic Surgery, People's Hospital of Yuxi City, Yuxi, Yunnan 653100, China.""}, {'ForeName': 'Shuang-Neng', 'Initials': 'SN', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopeadic Surgery, People's Hospital of Yuxi City, Yuxi, Yunnan 653100, China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Na', 'Affiliation': ""Department of Orthopeadic Surgery, People's Hospital of Yuxi City, Yuxi, Yunnan 653100, China.""}, {'ForeName': 'Li-Fen', 'Initials': 'LF', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopeadic Surgery, People's Hospital of Yuxi City, Yuxi, Yunnan 653100, China.""}, {'ForeName': 'Jing-An', 'Initials': 'JA', 'LastName': 'Hong', 'Affiliation': 'Department of Clinical Nutrition, The First Hospital of Yunnan Province, Kunming, Yunnan 650000, China.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181191']
732,31609772,Early Palliative Care Consultation in the Medical ICU: A Cluster Randomized Crossover Trial.,"OBJECTIVES


To assess the impact of early triggered palliative care consultation on the outcomes of high-risk ICU patients.
DESIGN


Single-center cluster randomized crossover trial.
SETTING


Two medical ICUs at Barnes Jewish Hospital.
PATIENTS


Patients (n = 199) admitted to the medical ICUs from August 2017 to May 2018 with a positive palliative care screen indicating high risk for morbidity or mortality.
INTERVENTIONS


The medical ICUs were randomized to intervention or usual care followed by washout and crossover, with independent assignment of patients to each ICU at admission. Intervention arm patients received a palliative care consultation from an interprofessional team led by board-certified palliative care providers within 48 hours of ICU admission.
MEASUREMENTS AND MAIN RESULTS


Ninety-seven patients (48.7%) were assigned to the intervention and 102 (51.3%) to usual care. Transition to do-not-resuscitate/do-not-intubate occurred earlier and significantly more often in the intervention group than the control group (50.5% vs 23.4%; p < 0.0001). The intervention group had significantly more transfers to hospice care (18.6% vs 4.9%; p < 0.01) with fewer ventilator days (median 4 vs 6 d; p < 0.05), tracheostomies performed (1% vs 7.8%; p < 0.05), and postdischarge emergency department visits and/or readmissions (17.3% vs 38.9%; p < 0.01). Although total operating cost was not significantly different, medical ICU (p < 0.01) and pharmacy (p < 0.05) operating costs were significantly lower in the intervention group. There was no significant difference in ICU length of stay (median 5 vs 5.5 d), hospital length of stay (median 10 vs 11 d), in-hospital mortality (22.6% vs 29.4%), or 30-day mortality between groups (35.1% vs 36.3%) (p > 0.05).
CONCLUSIONS


Early triggered palliative care consultation was associated with greater transition to do-not-resuscitate/do-not-intubate and to hospice care, as well as decreased ICU and post-ICU healthcare resource utilization. Our study suggests that routine palliative care consultation may positively impact the care of high risk, critically ill patients.",2019,"Although total operating cost was not significantly different, medical ICU (p < 0.01) and pharmacy (p < 0.05) operating costs were significantly lower in the intervention group.","['high-risk ICU patients', 'Two medical ICUs at Barnes Jewish Hospital', 'Patients (n = 199) admitted to the medical ICUs from August 2017 to May 2018 with a positive palliative care screen indicating high risk for morbidity or mortality']",['palliative care consultation from an interprofessional team led by board-certified palliative care providers'],"['ICU length of stay', 'postdischarge emergency department visits and/or readmissions', 'total operating cost', 'hospital mortality', 'transfers to hospice care', 'hospital length of stay', '30-day mortality', 'medical ICU', 'operating costs']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0178443', 'cui_str': 'Jewish, follower of religion (person)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]","[{'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0085555', 'cui_str': 'Hospice Care'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]",97.0,0.0982293,"Although total operating cost was not significantly different, medical ICU (p < 0.01) and pharmacy (p < 0.05) operating costs were significantly lower in the intervention group.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Duke Palliative Care, Department of Medicine, Duke University and Health System, Durham, NC.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chi', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Buettner', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Pollard', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Muir', 'Affiliation': 'Division of Palliative Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Charu', 'Initials': 'C', 'LastName': 'Kolekar', 'Affiliation': 'Division of Palliative Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Al-Hammadi', 'Affiliation': 'Division of Biostatistics, Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Marin', 'Initials': 'M', 'LastName': 'Kollef', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dans', 'Affiliation': 'Division of Palliative Medicine, Washington University School of Medicine, St. Louis, MO.'}]",Critical care medicine,['10.1097/CCM.0000000000004016']
733,31082669,Radium-223 in combination with docetaxel in patients with castration-resistant prostate cancer and bone metastases: a phase 1 dose escalation/randomised phase 2a trial.,"PURPOSE


Radium 223 dichloride (radium-223) is an alpha particle-emitting bone-directed therapy that prolongs overall survival in men with bone-predominant metastatic castration-resistant prostate cancer (mCRPC). Docetaxel is an antimicrotubule cytotoxic agent that improves survival in mCRPC. We investigated whether combining these potentially cross-sensitising agents to dually target tumour and bone would be safe and effective.
PATIENTS AND METHODS


Phase 1 was a dose escalation study to define a recommended phase 2 dose (RP2D) of docetaxel and radium-223. In phase 2a, patients were randomised 2:1 to the recommended combination regimen or docetaxel at a dose of 75 mg/m 2  every 3 weeks (q3w). Patients with bone-predominant mCRPC were eligible. End-points were safety, efficacy and treatment-related changes in serum and imaging biomarkers.
RESULTS


Twenty patients were enrolled in phase 1; 53 patients were randomised in phase 2a: 36 to combination treatment and 17 to docetaxel alone. The RP2D for the combination was radium-223 55 kBq/kg every six weeks × 5 doses, plus docetaxel 60 mg/m 2  q3w × 10 doses. Febrile neutropenia was dose limiting. A higher rate of febrile neutropenia was seen in the docetaxel monotherapy arm (15% vs 0%); the safety profile of the treatment groups was otherwise similar. The combination arm had more durable suppression of prostate-specific antigen (median time to progression, 6.6 vs 4.8 months, respectively), alkaline phosphatase (9 vs 7 months) and osteoblastic bone deposition markers.
CONCLUSIONS


Radium-223 in combination with docetaxel at the RP2D was well tolerated. Exploratory efficacy data suggested enhanced antitumour activity for the combination relative to docetaxel alone. Comparative studies with end-points of clinical benefit are warranted. ClinicalTrials.gov number: NCT01106352.",2019,"The combination arm had more durable suppression of prostate-specific antigen (median time to progression, 6.6 vs 4.8 months, respectively), alkaline phosphatase (9 vs 7 months) and osteoblastic bone deposition markers.
","['patients with castration-resistant prostate cancer and bone metastases', 'men with bone-predominant metastatic castration-resistant prostate cancer (mCRPC', 'Twenty patients were enrolled in phase 1; 53 patients', 'Patients with bone-predominant mCRPC were eligible']","['Radium 223 dichloride', 'plus docetaxel 60\xa0mg/m 2  q3w', 'Radium-223 in combination with docetaxel', 'docetaxel', 'docetaxel alone', 'docetaxel and radium-223', 'Docetaxel']","['tolerated', 'alkaline phosphatase', 'antitumour activity', 'safety profile', 'Febrile neutropenia', 'rate of febrile neutropenia', 'durable suppression of prostate-specific antigen', 'safety, efficacy\xa0and treatment-related changes in serum and imaging biomarkers', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}]","[{'cui': 'C0303282', 'cui_str': 'Ra-223 radioisotope'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",20.0,0.0447673,"The combination arm had more durable suppression of prostate-specific antigen (median time to progression, 6.6 vs 4.8 months, respectively), alkaline phosphatase (9 vs 7 months) and osteoblastic bone deposition markers.
","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, New York, NY, USA. Electronic address: morrism@mskcc.org.'}, {'ForeName': 'Yohann', 'Initials': 'Y', 'LastName': 'Loriot', 'Affiliation': 'Department of Cancer Medicine, INSERM U981, Gustave Roussy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Sweeney', 'Affiliation': 'Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Department of Cancer Medicine, INSERM U981, Gustave Roussy, Université Paris-Saclay, Villejuif, France.'}, {'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'Department of Medicine and Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Shevrin', 'Affiliation': 'NorthShore Medical Group, NorthShore University Health System, Evanston Hospital Kellogg Cancer Center, Evanston, IL, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'The Sydney Kimmel Comprehensive Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Pandit-Taskar', 'Affiliation': 'Department of Radiology, Molecular Imaging and Therapy Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'Deandreis', 'Affiliation': 'Nuclear Medicine and Endocrine Oncology, Institut Gustave Roussy, University of Paris Sud, Villejuif, France.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Jacene', 'Affiliation': ""Department of Imaging, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Radiology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Vesselle', 'Affiliation': 'Division of Nuclear Medicine, Department of Radiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Petrenciuc', 'Affiliation': 'Department of Global Clinical Development, Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Department of Global Clinical Development, Bayer HealthCare Pharmaceuticals, Whippany, NJ, USA.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Carrasquillo', 'Affiliation': 'Department of Radiology, Molecular Imaging and Therapy Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Celestia S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'Department of Medicine, University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.04.007']
734,31746743,"A multicentre, randomised controlled clinical study of drug-coated balloons for the treatment of coronary in-stent restenosis.","AIMS


Treatment of in-stent restenosis of coronary stents is challenging. The use of drug-coated balloons (DCB) is a promising technique to treat in-stent restenosis without adding another metal layer. The aim of the AGENT ISR randomised trial is to evaluate angiographic and clinical outcomes in patients with ISR of a previously treated lesion who were treated with either a DCB with a new coating formulation (Agent) or a standard DCB (SeQuent Please).
METHODS AND RESULTS


AGENT ISR is a multicentre, randomised, open-label, non-inferiority study comparing the Agent and SeQuent Please DCB. A total of 125 patients (mean age ~68 years, 18% female) with in-stent restenosis of a previously treated lesion <28 mm in length were randomised at 11 sites in Europe to Agent (n=65) or SeQuent Please (n=60). The primary endpoint, six-month in-stent late lumen loss, in the Agent group (0.397±0.43 mm [n=51]) was non-inferior to that of the SeQuent Please group (0.393±0.536 mm [n=49]), as the two-sided upper 95% confidence boundary for the difference between groups was less than the pre-specified non-inferiority margin of 0.20 (difference 0.004, 95% CI [-0.189, 0.196]; pnon-inferiority=0.046). At one year, mortality was 3.1% in Agent and 1.7% in SeQuent Please patients (p>0.99), target lesion revascularisation 7.7% versus 10.0% (p=0.89), and stent thrombosis 0% versus 3.3% (p=0.44). Similar improvements in quality of life were seen in the two groups.
CONCLUSIONS


In this head-to-head comparison of two DCB, Agent proved to be non-inferior to SeQuent Please for in-stent late lumen loss at six months.
CLINICAL TRIALS REGISTRATION


NCT02151812 (http://clinicaltrials.gov/).",2020,"Please patients (P&gt;0.99), target lesion revascularisation 7.7% vs. 10.0% (P=0.89), and stent thrombosis 0% vs. 3.3% (P=0.44).","['125 patients (mean age ~68 years, 18% female) with in-stent restenosis of a previously treated lesion &lt;28 mm in length were randomised at 11 sites in Europe to Agent (n=65) or', 'Coronary In-stent Restenosis']","['drug-coated balloons (DCB', 'SeQuent']","['mortality', 'target lesion revascularisation', 'quality of life', '6-month in-stent late lumen loss', 'stent thrombosis']","[{'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",125.0,0.110984,"Please patients (P&gt;0.99), target lesion revascularisation 7.7% vs. 10.0% (P=0.89), and stent thrombosis 0% vs. 3.3% (P=0.44).","[{'ForeName': 'Christian W', 'Initials': 'CW', 'LastName': 'Hamm', 'Affiliation': 'Universität Giessen, Giessen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Dörr', 'Affiliation': ''}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Woehrle', 'Affiliation': ''}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krackhardt', 'Affiliation': ''}, {'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Ince', 'Affiliation': ''}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Zeus', 'Affiliation': ''}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Berland', 'Affiliation': ''}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Piot', 'Affiliation': ''}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': ''}, {'ForeName': 'Ingolf', 'Initials': 'I', 'LastName': 'Schult', 'Affiliation': ''}, {'ForeName': 'Dominic J', 'Initials': 'DJ', 'LastName': 'Allocco', 'Affiliation': ''}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Nef', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00051']
735,31096265,The Relationship of Varenicline Agonism of α4β2 Nicotinic Acetylcholine Receptors and Nicotine-Induced Dopamine Release in Nicotine-Dependent Humans.,"INTRODUCTION


Cigarette smoking continues to be one of the most important behavioral causes of morbidity and mortality in the world. Varenicline, an α4β2 nicotinic acetylcholine receptor (nAChR) partial agonist, has been shown to increase smoking quit rates compared with nicotine-based products. This human laboratory, double-blind, placebo-controlled study examined varenicline and placebo effects on α4β2-nAChRs occupancy, nicotine-induced change in [11C]raclopride non-displaceable binding potential (BPND), and behavioral measures of cigarette smoking, nicotine craving, and withdrawal.
METHODS


Current nicotine dependent daily smokers (N = 17) were randomized to varenicline 1 mg twice daily or placebo for 13 days. Using positron emission tomography), we characterized α4β2-nAChRs occupancy using [18F]AZAN and dopamine receptor binding using [11C]raclopride as well as behavioral measures of cigarettes smoked, craving, and nicotine withdrawal.
RESULTS


Varenicline compared with placebo resulted in significant reductions in [18F]AZAN BPND in multiple brain regions including thalamus, midbrain, putamen, and ventral striatum. Following administration of a controlled-dose nicotine cigarette, dopamine release was significantly suppressed in the ventral striatum in the varenicline-treated compared with the placebo group. There was a significant relationship between α4β2-nAChRs BPND measured in thalamus during the [18F]AZAN scan and nicotine-induced change in raclopride BPND in the ventral striatum.
CONCLUSION


This is the first human study to demonstrate a direct relationship between the extent of varenicline occupancy of α4β2-nAChRs and the magnitude of dopamine release following nicotine use.
IMPLICATIONS


It has remained unclear how nicotinic receptor blockade through partial agonist medications such as varenicline promotes smoking cessation. One hypothesized mechanism is downstream dampening of the mesolimbic reward dopamine system. For the first time in human smokers, we observed a direct relationship between the extent of varenicline blockade of α4β2-nACh nicotinic receptors and the magnitude of dopamine release following smoking. This has mechanistic and therapeutic implications for improving smoking cessation interventions.",2020,"RESULTS


Varenicline compared with placebo resulted in significant reductions in [18F]AZAN BPND in multiple brain regions including thalamus, midbrain, putamen and ventral striatum.","['Current nicotine dependent, daily smokers (N=17', 'human smokers']","['Varenicline', 'placebo', 'varenicline 1 mg twice daily or placebo', 'varenicline and placebo', 'positron emission tomography (PET']","['18F]AZAN BPND in multiple brain regions including thalamus, midbrain, putamen and ventral striatum', 'α4β2-nAChRs occupancy, nicotine-induced change in [11C]raclopride binding potential (BPND) and behavioral measures of cigarette smoking, nicotine craving, and withdrawal', 'ventral striatum', 'raclopride BPND', 'smoking quit rates', 'α4β2-nAChRs BPND']","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1712046', 'cui_str': 'varenicline 1 MG [Chantix]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0031268', 'cui_str': 'Companion Animals'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1273723', 'cui_str': 'Brain region'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0039729', 'cui_str': 'Thalamencephalon'}, {'cui': 'C0025462', 'cui_str': 'Midbrain'}, {'cui': 'C0034169', 'cui_str': 'Nucleus Putamen'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0072953', 'cui_str': 'Raclopride'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0872355', 'cui_str': 'Nicotine craving'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",17.0,0.0570948,"RESULTS


Varenicline compared with placebo resulted in significant reductions in [18F]AZAN BPND in multiple brain regions including thalamus, midbrain, putamen and ventral striatum.","[{'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'McCaul', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Wand', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Radiology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Dannals', 'Affiliation': 'Department of Radiology, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz080']
736,30697730,Can reciprocated parent-child eye gaze and emotional engagement enhance treatment for children with conduct problems and callous-unemotional traits: a proof-of-concept trial.,"BACKGROUND


High levels of callous-unemotional (CU) traits are associated with reduced effectiveness of parenting programmes for children with conduct problems. This may be due to low levels of emotional engagement (EE) by these children with their parents. We evaluate a theoretically driven strategy for improving emotional engagement in high CU traits children undergoing a parenting intervention (parent management training; PMT) for child conduct problems.
METHODS


N = 40, 3- to 8-year-old children referred for conduct problems and showing stable, high levels of CU traits, were randomised to receive PMT+Emotional Engagement (EE), or the control condition PMT+Child Centred Play (CCP). A benchmarking sample of N = 70 children who received PMT only was also included. Observational coding of the parent-child interactions targeted by EE and CCP respectively was repeated throughout treatment and follow-up.
RESULTS


Emotional engagement produced unique improvements in parent-child emotional engagement (shared eye gaze); however, these reverted to baseline levels after treatment. CCP produced unique improvements in parents' child centeredness and child positive play, but by post-treatment, all children had improved on these factors. Both interventions produced similar improvements in general parental warmth. Reductions in severity of conduct problems at post-treatment and follow-up were large in size and did not differ between conditions or from the benchmarking group. Levels of CU traits reduced significantly but again did not differ between groups.
CONCLUSIONS


The putative mechanism of emotional engagement through reciprocated eye gaze proved to be impervious to sustained change, and thus failed to have a specific impact of conduct problems or levels of CU traits. The development of novel treatment approaches to children with high levels of CU is a challenging endeavour, and these results indicate that focussing on children with stable levels at pretreatment should be a priority.",2019,Reductions in severity of conduct problems at post-treatment and follow-up were large in size and did not differ between conditions or from the benchmarking group.,"['children with conduct problems', 'children with their parents', 'high CU traits children undergoing a', 'children with high levels of CU', 'A benchmarking sample of N\xa0=\xa070 children who received PMT only was also included', '40, 3- to 8-year-old children referred for conduct problems and showing stable, high levels of CU traits', 'children with conduct problems and callous-unemotional traits', 'N\xa0']","['parenting intervention (parent management training; PMT', 'CCP', 'PMT+Emotional Engagement (EE), or the control condition PMT+Child Centred Play (CCP']","['emotional engagement', ""parents' child centeredness and child positive play"", 'general parental warmth', 'Levels of CU traits', 'parent-child emotional engagement (shared eye gaze', 'severity of conduct problems']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0525063', 'cui_str': 'Best Practice Analysis'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0647195', 'cui_str': 'PMTS'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0647195', 'cui_str': 'PMTS'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4505383', 'cui_str': 'Eye Gaze'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",70.0,0.139789,Reductions in severity of conduct problems at post-treatment and follow-up were large in size and did not differ between conditions or from the benchmarking group.,"[{'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Dadds', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'English', 'Affiliation': 'University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Subodha', 'Initials': 'S', 'LastName': 'Wimalaweera', 'Affiliation': 'University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Schollar-Root', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hawes', 'Affiliation': 'University of Sydney, Sydney, NSW, Australia.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13023']
737,31740092,Atomized intranasal vs intravenous fentanyl in severe renal colic pain management: A randomized single-blinded clinical trial.,"OBJECTIVES


Renal colic is one of the most common painful disorders in patients referred to the emergency department. The main purpose of this study was to compare the efficiency of two methods of intravenous (IVF) and intranasal (INF) fentanyl administration in pain management in patients with severe renal colic.
MATERIALS & METHODS


This was a single-blind randomized clinical trial performed on patients with severe renal colic. The severity of pain was ≥8 based on the Numerical Rating Scale (NRS). The efficacy of pain management was compared within and between the IVF (intramuscular Ketorolac + intravenous fentanyl) and INF (intramuscular Ketorolac + intranasal fentanyl) groups at different times points. Oral consent was obtained from all the patients.
RESULTS


Of 220 individuals, 96 (43.60%) were women and 124 (56.40%) were men. There were no significant differences between the two groups regarding the baseline pain severity, age, sex, history of urolithiasis and body mass index (BMI). The pain severity showed a significant reducing trend in both groups (p < 0.0001). There was also a significant difference comparing the mean pain severity between groups at different times (p < 0.0001). In each group, the severity of pain showed significant reduction compared with its prior measurement (P < 0.0001).
CONCLUSION


Fentanyl is highly effective in controlling pain in patients with severe renal colic referring to the emergency department. Intranasal administration of fentanyl combination with ketorolac can be an appropriate, non-invasive, easy-to-use and fast alternative to the intravenous method to manage pain in these patients.",2020,"In each group, the severity of pain showed significant reduction compared with its prior measurement (P < 0.0001).
","['patients with severe renal colic referring to the emergency department', 'Of 220 individuals, 96 (43.60%) were women and 124 (56.40%) were men', 'severe renal colic pain management', 'patients with severe renal colic', 'patients referred to the emergency department']","['Fentanyl', 'Atomized intranasal vs intravenous fentanyl', 'fentanyl combination with ketorolac', 'IVF (intramuscular Ketorolac + intravenous fentanyl) and INF (intramuscular Ketorolac + intranasal fentanyl', 'intravenous (IVF) and intranasal (INF) fentanyl administration']","['efficacy of pain management', 'mean pain severity', 'baseline pain severity, age, sex, history of urolithiasis and body mass index (BMI', 'Numerical Rating Scale (NRS', 'severity of pain', 'pain severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0152169', 'cui_str': 'Acute Renal Colic'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0451641', 'cui_str': 'Urinary Lithiasis'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0222045'}]",220.0,0.0731758,"In each group, the severity of pain showed significant reduction compared with its prior measurement (P < 0.0001).
","[{'ForeName': 'Narjes', 'Initials': 'N', 'LastName': 'Nazemian', 'Affiliation': 'Department of Emergency Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Torabi', 'Affiliation': 'Department of Emergency Medicine, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: me_torabi@kmu.ac.ir.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.158483']
738,31018616,Changes in Pancreatic Fat Content Following Diet-Induced Weight Loss.,"BACKGROUND


Obesity can lead to ectopic pancreatic fat accumulation and increase the risk for type 2 diabetes. Smaller intervention trials have shown a decrease in pancreatic fat content (PFC) with weight loss, and we intended to investigate the effects of weight loss on PFC in a larger trial.
METHODS


Data from the HELENA-Trial, a randomized controlled trial (RCT) among 137 non-diabetic obese adults were used. The study cohort was classified into 4 quartiles based on weight change between baseline and 12 weeks post-intervention. Changes in PFC (baseline, 12 weeks and 50 weeks post-intervention) upon weight loss were analyzed by linear mixed models. Spearman's coefficients were used to obtain correlations between anthropometric parameters, blood biochemical markers, and PFC.
RESULTS


At baseline, PFC only showed a significant correlation with visceral adipose tissue (VAT) ( r  = 0.41). Relative changes in PFC were significantly ( p  = 0.01) greater in Q4 (-30.8 ± 5.7%) than in Q1 (1.3 ± 6.7%). These differences remained similar after one year. However, when adjusting the statistical analyses for changes in VAT, the differences in PFC between Q1 and Q4 were no longer statistically significant.
CONCLUSION


Weight loss is associated with a decrease in PFC. However, the reduction of PFC is not independent from reductions in VAT. Unlike VAT, PFC was not associated with metabolic biomarkers.",2019,Relative changes in PFC were significantly ( p  = 0.01),['137 non-diabetic obese adults'],[],"['weight loss', 'Pancreatic Fat Content', 'Weight loss', 'visceral adipose tissue (VAT', 'PFC', 'anthropometric parameters, blood biochemical markers, and PFC', 'weight change']","[{'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1563740', 'cui_str': 'Visceral Fat'}, {'cui': 'C0752151', 'cui_str': 'VATS'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005768'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}]",137.0,0.0362021,Relative changes in PFC were significantly ( p  = 0.01),"[{'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany. Yixin.Jiang@med.uni-heidelberg.de.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Spurny', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany. Manuela.Spurny@med.uni-heidelberg.de.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Schübel', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany. ruth.schuebel@gmx.de.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Nonnenmacher', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany. tno144@googlemail.com.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Schlett', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany. christopher.schlett@uniklinik-freiburg.de.'}, {'ForeName': 'Oyunbileg', 'Initials': 'O', 'LastName': 'von Stackelberg', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany. oyunbileg.stackelberg@med.uni-heidelberg.de.'}, {'ForeName': 'Cornelia M', 'Initials': 'CM', 'LastName': 'Ulrich', 'Affiliation': 'Huntsman Cancer Institute and Department of Population Health Sciences, University of Utah, 2000 Circle of Hope, Salt Lake City, UT 84112-5550, USA. neli@hci.utah.edu.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Kaaks', 'Affiliation': 'German Cancer Research Center (DKFZ), Division of Cancer Epidemiology, Im Neuenheimer Feld 581, 69120 Heidelberg, Germany. r.kaaks@Dkfz-Heidelberg.de.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Kauczor', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany. Hans-Ulrich.Kauczor@med.uni-heidelberg.de.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Kühn', 'Affiliation': 'German Cancer Research Center (DKFZ), Division of Cancer Epidemiology, Im Neuenheimer Feld 581, 69120 Heidelberg, Germany. t.kuehn@Dkfz-Heidelberg.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Nattenmüller', 'Affiliation': 'Heidelberg University Hospital, Diagnostic and Interventional Radiology, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany. Johanna.nattenmueller@med.uni-heidelberg.de.'}]",Nutrients,['10.3390/nu11040912']
739,31736342,Sacubitril/Valsartan Across the Spectrum of Ejection Fraction in Heart Failure.,"BACKGROUND


While disease-modifying therapies exist for heart failure (HF) with reduced left ventricular ejection fraction (LVEF), few options are available for patients in the higher range of LVEF (>40%). Sacubitril/valsartan has been compared with a renin-angiotensin-aldosterone-system inhibitor alone in 2 similarly designed clinical trials of patients with reduced and preserved LVEF, permitting examination of its effects across the full spectrum of LVEF.
METHODS


We combined data from PARADIGM-HF (LVEF eligibility≤40%; n=8399) and PARAGON-HF (LVEF eligibility≥45%; n=4796) in a prespecified pooled analysis. We divided randomized patients into LVEF categories: ≤22.5% (n=1269), >22.5% to 32.5% (n=3987), >32.5% to 42.5% (n=3143), > 42.5% to 52.5% (n=1427), > 52.5% to 62.5% (n=2166), and >62.5% (n=1202). We assessed time to first cardiovascular death and HF hospitalization, its components, and total heart failure hospitlizations, all-cause mortality, and noncardiovascular mortality. Incidence rates and treatment effects were examined across categories of LVEF.
RESULTS


Among 13 195 randomized patients, we observed lower rates of cardiovascular death and HF hospitalization, but similar rates of noncardiovascular death, among patients in the highest versus the lowest groups. Overall sacubitril/valsartan was superior to renin-angiotensin-aldosterone-system inhibition for first cardiovascular death or heart failure hospitalization (Hazard Ratio [HR] 0.84 [95% CI, 0.78-0.90]), cardiovascular death (HR 0.84 [95% CI, 0.76-0.92]), heart failure hospitalization (HR 0.84 [95% CI, 0.77-0.91]), and all-cause mortality (HR 0.88 [95% CI, 0.81-0.96]). The effect of sacubitril/valsartan was modified by LVEF (treatment-by-continuous LVEF interaction  P =0.02), and benefit appeared to be present for individuals with EF primarily below the normal range, although the treatment benefit for cardiovascular death diminished at a lower ejection fraction. We observed effect modification by LVEF on the efficacy of sacubitril/valsartan in both men and women with respect to composite total HF hospitalizations and cardiovascular death, although women derived benefit to higher ejection fractions.
CONCLUSIONS


The therapeutic effects of sacubitril/valsartan, compared with a renin-angiotensin-aldosterone-system inhibitor alone, vary by LVEF with treatment benefits, particularly for heart failure hospitalization, that appear to extend to patients with heart failure and mildly reduced ejection fraction. These therapeutic benefits appeared to extend to a higher LVEF range in women compared with men.
CLINICAL TRIAL REGISTRATION


https://www.clinicaltrials.gov. Unique identifiers: NCT01920711 (PARAGON-HF), NCT01035255 (PARADIGM-HF).",2020,"Overall sacubitril/valsartan was superior to RAS inhibition for first cardiovascular death or heart failure hospitalization (HR 0.84, 95% CI 0.78, 0.90), cardiovascular death (HR 0.84, 95% CI 0.76, 0.92), heart failure hospitalization (HR 0.84, 95% CI 0.77, 0.91), and all-cause mortality (HR 0.88, 95% CI 0.81, 0.96).","['patients with heart failure and mildly reduced ejection fraction', 'men and women with respect to composite total HF hospitalizations and cardiovascular death, although women derived benefit to higher ejection fractions', 'patients in the higher range of LVEF (>40', '13,195 randomized patients']","['Sacubitril/Valsartan', 'sacubitril/valsartan', 'Sacubitril/valsartan', 'LVEF']","['rates of non-cardiovascular death', 'cardiovascular death and HF hospitalization', 'time to first cardiovascular death and HF hospitalization, its components, and total heart failure hospitlizations, all-cause mortality and non-cardiovascular mortality', 'Incidence rates', 'heart failure hospitalization', 'RAS inhibition for first cardiovascular death or heart failure hospitalization', 'cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C3539085', 'cui_str': 'All'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",,0.115373,"Overall sacubitril/valsartan was superior to RAS inhibition for first cardiovascular death or heart failure hospitalization (HR 0.84, 95% CI 0.78, 0.90), cardiovascular death (HR 0.84, 95% CI 0.76, 0.92), heart failure hospitalization (HR 0.84, 95% CI 0.77, 0.91), and all-cause mortality (HR 0.88, 95% CI 0.81, 0.96).","[{'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).""}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'L Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).""}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX (M.P.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina, Charleston (M.Z.).'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Swedberg', 'Affiliation': 'Department of Molecular and Clinical Medicine, University of Gothenburg, Sweden (K.S.).'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Rouleau', 'Affiliation': 'Institut de Cardiologie de Montréal, Université de Montréal, Canada (J.R.).'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'A Pfeffer', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).""}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (S.D.S., M.V., B.L.C., M.A.P., A.D.).""}, {'ForeName': 'Lars H', 'Initials': 'LH', 'LastName': 'Lund', 'Affiliation': 'Department of Medicine, Karolinska Institutet, and Heart and Vascular Theme, Karolinska University Hospital, Stockholm, Sweden (L.H.L.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kober', 'Affiliation': 'Department of Cardiology, Heart Centre, Rigshospitalet, Copenhagen University Hospital, Denmark (L.K.).'}, {'ForeName': 'Inder', 'Initials': 'I', 'LastName': 'Anand', 'Affiliation': 'Department of Medicine, VA Medical Center and University of Minnesota, Minneapolis (I.A.).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Sweitzer', 'Affiliation': 'Sarver Heart Center, University of Arizona College of Medicine, Tucson (N.S.).'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Linssen', 'Affiliation': 'Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, The Netherlands (G.L.).'}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Luis Arango', 'Affiliation': 'Guatemalan Heart Institute (J.L.A.).'}, {'ForeName': 'Dragos', 'Initials': 'D', 'LastName': 'Vinereanu', 'Affiliation': 'University of Medicine and Pharmacy Carol Davila, University and Emergency Hospital of Bucharest, Romania (D.V.).'}, {'ForeName': 'Chen-Huan', 'Initials': 'CH', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, National Yang-Ming University, Taipei, Taiwan, Republic of China (C.-H.C.).'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Hospital Papa Giovanni XXIII, Bergamo, Italy (M.S.).'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Sibulo', 'Affiliation': ""St Luke's Heart Institute, St. Luke's Medical Center, Taguig, Philippines (A.S.).""}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Boytsov', 'Affiliation': 'National Research Center for Cardiology of the Ministry of Health of the Russian Federation, Moscow (S.B.).'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Shi', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ (V.S, A.R., M.L.).'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Rizkala', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ (V.S, A.R., M.L.).'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lefkowitz', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ (V.S, A.R., M.L.).'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, United Kingdom (J.J.V.M.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.044586']
740,31090087,"Efficacy of Combined Intense Pulsed Light (IPL) With Fractional CO 2  -Laser Ablation in the Treatment of Large Hypertrophic Scars: A Prospective, Randomized Control Trial.","BACKGROUND AND OBJECTIVES


Scar rehabilitation is a complex process that incorporates medical, surgical, and physical therapeutic measures to best restore function and visual normalcy. Lasers have emerged as essential tools in the management of scars, with devices available to address scar size, dyschromia, and contour irregularities. As different lasers treat these different features, multi-laser, same session therapeutic approaches may offer a more comprehensive approach to scar revision. In this study, we aim to demonstrate the effect of a combinatorial, same session treatment with intense pulsed light (IPL) and fractional ablative CO 2  as compared to single laser treatment with fractional ablative CO 2  laser alone or control in the treatment of mature hypertrophic scars.
MATERIALS AND METHODS


This institutional review board-approved, randomized controlled trial, enrolled 23 healthy adults with large (>100 cm 2  ) hypertrophic scars who were randomized to one of three treatment arms: (i) IPL and CO 2  ablative fractional laser (AFL), (ii) CO 2  AFL alone, and (iii) control (no laser treatment). Subjects underwent a total of four treatment sessions at 6-8-week intervals with follow-up visits at 1, 3, and 6 months following the last treatment session. Primary endpoints included blinded scoring of before and after photographs via the Manchester Scar Scale (MSS). Secondary endpoints included the Patient-Observer Scar Assessment Scale (POSAS).
RESULTS


As compared to control and CO 2  AFL laser alone, the combination of CO 2  AFL and IPL demonstrated statistically significant improvement across a greater number of scar domains, as assessed by the MSS. 100% of subjects in both treatment groups showed a statistically significant decrease in the POSAS scale after the series of four treatment sessions. No adverse events were reported.
CONCLUSION


Treatment with combined IPL and CO 2  AFL demonstrated higher average improvements across the majority of assessed scar domains, as compared to both control and CO 2  laser alone. The difference was not statistically significant in overall MSS score as expected due to the role of CO 2  as the main source of improvement. However, only the combination group had statistically significant improvement in both color and texture. These findings support the assertion that a multi-photo-thermolytic approach with combined IPL and CO 2  AFL can have a positive impact on the treatment of hypertrophic scars by using multiple wavelengths to maximize laser-skin interactions in targeting the different chromophores expressed in scar tissue. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.",2019,100% of subjects in both treatment groups showed a statistically significant decrease in the POSAS scale after the series of four treatment sessions.,"['mature hypertrophic scars', 'enrolled 23 healthy adults with large (>100\u2009cm 2  ) hypertrophic scars', 'Large Hypertrophic Scars', '2019']","['Combined Intense Pulsed Light (IPL) With Fractional CO 2  -Laser Ablation', 'fractional ablative CO 2  laser alone or control', 'IPL and CO 2  ablative fractional laser (AFL), (ii) CO 2  AFL alone, and (iii) control (no laser treatment']","['POSAS scale', 'blinded scoring of before and after photographs via the Manchester Scar Scale (MSS', 'Patient-Observer Scar Assessment Scale (POSAS', 'adverse events', 'overall MSS score', 'number of scar domains']","[{'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0162810', 'cui_str': 'Scars, Hypertrophic'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0348007', 'cui_str': 'Pulsed Laser Tissue Ablation'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0222045'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",23.0,0.02257,100% of subjects in both treatment groups showed a statistically significant decrease in the POSAS scale after the series of four treatment sessions.,"[{'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Daoud', 'Affiliation': 'Department of Dermatology, Stony Brook University, Stony Brook, New York, 11794.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Gianatasio', 'Affiliation': 'Miami Dermatology & Laser Institute, Miami, Florida, 33173.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Rudnick', 'Affiliation': 'Miami Dermatology & Laser Institute, Miami, Florida, 33173.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Michael', 'Affiliation': 'Lake Erie College of Osteopathic Medicine, Bradenton, Florida, 34211.'}, {'ForeName': 'JillS', 'Initials': 'J', 'LastName': 'Waibel', 'Affiliation': 'Miami Dermatology & Laser Institute, Miami, Florida, 33173.'}]",Lasers in surgery and medicine,['10.1002/lsm.23092']
741,32014832,Cost-effectiveness of preventing child internalising problems: Results from the translational trial of Cool Little Kids at school entry.,"OBJECTIVE


A translational trial evaluated the effectiveness of screening for inhibited childhood temperament, followed by a preventive parenting program -Cool Little Kids. This study determined the cost-effectiveness from societal and health sector perspectives using trial data.
METHOD


Resources to deliver the screening and parenting sessions were determined from study records. Parents completed a questionnaire reporting resources used at one-year follow-up. Standard Australian unit costs were applied. Clinical outcomes for children and parental quality adjusted life-years (QALYs) were used to calculate incremental cost-effectiveness ratios (ICERs).
RESULTS


Total societal costs were lower, but non-significant for the intervention compared to the control group (mean difference -$500 p = 0.937). Total health sector costs were significantly greater (mean difference $1,956; p = 0.015). The intervention led to significantly fewer internalising symptoms (Strengths and Difficulties Questionnaire (SDQ)-emotional difficulties adjusted mean difference -0.5; p = 0.006), fewer children with SDQ-emotional symptoms in the abnormal range (24.2 % vs. 33.0 % p = .014) and fewer with diagnosed anxiety (44.2 % vs. 50.2 % p = 0.427). From the societal perspective, the intervention would likely be cost-effective. Health sector ICERs were $1,171/SDQ-emotional symptom decrease, $51/abnormal SDQ avoided and $77/anxiety case avoided.
CONCLUSIONS


This economic analysis alongside an implementation study provides an early indication that Cool Little Kids may be cost-effective.",2020,"Total health sector costs were significantly greater (mean difference $1,956; p = 0.015).","['Cool Little Kids at school entry', 'child internalising problems']",['preventive parenting program -Cool'],"['Total health sector costs', 'incremental cost-effectiveness ratios (ICERs', 'children with SDQ-emotional symptoms', 'diagnosed anxiety', 'Health sector ICERs', 'Cost-effectiveness', 'internalising symptoms (Strengths and Difficulties Questionnaire', 'Total societal costs']","[{'cui': 'C0700321', 'cui_str': 'Small (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire (assessment scale)'}]",,0.0540042,"Total health sector costs were significantly greater (mean difference $1,956; p = 0.015).","[{'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Chatterton', 'Affiliation': 'Deakin University, Deakin Health Economics, Institute for Health Transformation, Geelong, VIC, Australia. Electronic address: m.chatterton@deakin.edu.au.'}, {'ForeName': 'Jordana K', 'Initials': 'JK', 'LastName': 'Bayer', 'Affiliation': ""School of Psychology and Public Health, La Trobe University, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, The University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Engel', 'Affiliation': 'Deakin University, Deakin Health Economics, Institute for Health Transformation, Geelong, VIC, Australia.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Rapee', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Beatson', 'Affiliation': ""School of Psychology and Public Health, La Trobe University, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia.""}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Hiscock', 'Affiliation': ""School of Psychology and Public Health, La Trobe University, Melbourne, VIC, Australia; Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, The University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Bretherton', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, The University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Wake', 'Affiliation': ""Murdoch Children's Research Institute, Melbourne, VIC, Australia; Department of Paediatrics, The University of Melbourne, Melbourne, VIC, Australia.""}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'Deakin University, Deakin Health Economics, Institute for Health Transformation, Geelong, VIC, Australia.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102191']
742,30654196,Efficacy and Safety of Omalizumab (Xolair) for Cholinergic Urticaria in Patients Unresponsive to a Double Dose of Antihistamines: A Randomized Mixed Double-Blind and Open-Label Placebo-Controlled Clinical Trial.,"BACKGROUND


Cholinergic urticaria (UCOL) is a highly disabling inducible urticaria triggered by an increase in core body temperature.
OBJECTIVE


To explore the safety and efficacy of omalizumab in controlling UCOL.
METHODS


We conducted a multicenter randomized mixed double-blind and open-label (first 4 months blinded followed by 8 months open-label) placebo-controlled clinical trial in 22 patients suffering from UCOL who were unresponsive to a double dose of antihistamines. We performed an exercise challenge test during each visit as our main outcome variable.
RESULTS


The overall rate of exercise challenge test negative at week 48 was 31.3%, with an average increase in exercise challenge test negative rate of 2.9% points (95% CI, 1.5-4.2) per visit. Statistically significant differences in the negative exercise challenge test rate between the placebo and active intervention groups were not observed during the blinded period (first 4 months of the study). However, from the fourth dose, a progressive improvement was observed. When comparing before and after treatment, statistically significant improvements in all secondary outcome measures were noted after 4 doses (UCOL score: P = .0015; visual analog scale score: P = .0108; days with symptoms: P = .0125) and after 8 doses (UCOL score: P = .0005; chronic urticaria quality of life questionnaire: P = .0105; visual analog scale score: P = .0008; and days with symptoms: P = .0144). In the follow-up visit after the cessation of treatment, the symptoms reappeared, with positive exercise challenge test result and significant increases in all variables. Only 4 of 22 patients remained asymptomatic after 3 months of no treatment. No adverse effects were reported.
CONCLUSIONS


This randomized mixed double-blind and open-label placebo-controlled trial showed evidence of the safety and potential efficacy of omalizumab in patients with UCOL.",2019,Statistically significant differences in the negative exercise challenge test rate between the placebo and active intervention groups were not observed during the blinded period (first 4 months of the study).,"['patients with UCOL', '22 patients suffering from UCOL who were unresponsive to a double dose of', 'Patients Unresponsive to a Double Dose of Antihistamines']","['open-label (first 4 months blinded followed by 8 months open-label) placebo', 'Open-Label', 'placebo', 'Placebo', 'open-label placebo', 'Omalizumab (Xolair', 'omalizumab', 'antihistamines']","['safety and efficacy', 'adverse effects', 'chronic urticaria quality of life questionnaire', 'progressive improvement', 'overall rate of exercise challenge test negative', 'negative exercise challenge test rate', 'exercise challenge test negative rate', 'visual analog scale score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C1174773', 'cui_str': 'Xolair'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0263338', 'cui_str': 'Chronic urticaria (disorder)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1293901', 'cui_str': 'Exercise challenge'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",22.0,0.647112,Statistically significant differences in the negative exercise challenge test rate between the placebo and active intervention groups were not observed during the blinded period (first 4 months of the study).,"[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Gastaminza', 'Affiliation': 'Department of Allergy and Clinical Immunology, Clinica Universidad de Navarra, Pamplona, Spain; Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain; RETIC de Asma, Reacciones adversas y Alérgicas (ARADYAL), Madrid, Spain.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Azofra', 'Affiliation': 'Allergy Section, Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Jorge M', 'Initials': 'JM', 'LastName': 'Nunez-Cordoba', 'Affiliation': 'Clínica Universidad de Navarra, Research Support Service, Central Clinical Trials Unit, Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Baeza', 'Affiliation': 'Allergy Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain; Biomedical Research Network on Rare Diseases (CIBERER)-U761, Madrid, Spain; Gregorio Marañón Health Research Institute, Madrid, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Echechipía', 'Affiliation': 'Allergy Service, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Gaig', 'Affiliation': ""Allergy Section, Hospital Universitari Joan XXIII de Tarragona, Tarragona, Spain; Departament de Medicina i Cirurgia, Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Tarragona, Spain.""}, {'ForeName': 'Blanca Esther', 'Initials': 'BE', 'LastName': 'García', 'Affiliation': 'RETIC de Asma, Reacciones adversas y Alérgicas (ARADYAL), Madrid, Spain; Allergy Service, Complejo Hospitalario de Navarra, Pamplona, Spain.'}, {'ForeName': 'Moises', 'Initials': 'M', 'LastName': 'Labrador-Horrillo', 'Affiliation': ""RETIC de Asma, Reacciones adversas y Alérgicas (ARADYAL), Madrid, Spain; Allergy Section, Internal Medicine Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Sala-Cunill', 'Affiliation': ""RETIC de Asma, Reacciones adversas y Alérgicas (ARADYAL), Madrid, Spain; Allergy Section, Internal Medicine Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Marina Sabaté', 'Initials': 'MS', 'LastName': 'Brescó', 'Affiliation': 'Department of Allergy and Clinical Immunology, Clinica Universidad de Navarra, Pamplona, Spain; Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain; RETIC de Asma, Reacciones adversas y Alérgicas (ARADYAL), Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Beristain', 'Affiliation': 'Allergy Section, Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Quiñones', 'Affiliation': 'Allergy Section, Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'Carmen Díaz', 'Initials': 'CD', 'LastName': 'Donado', 'Affiliation': 'Allergy Section, Hospital Universitario Central de Asturias, Oviedo, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Zubeldia', 'Affiliation': 'Allergy Service, Hospital General Universitario Gregorio Marañón, Madrid, Spain; Biomedical Research Network on Rare Diseases (CIBERER)-U761, Madrid, Spain; Gregorio Marañón Health Research Institute, Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ferrer', 'Affiliation': 'Department of Allergy and Clinical Immunology, Clinica Universidad de Navarra, Pamplona, Spain; Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain; RETIC de Asma, Reacciones adversas y Alérgicas (ARADYAL), Madrid, Spain. Electronic address: mferrerp@unav.es.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2018.12.025']
743,29705935,Project SHINE: effects of a randomized family-based health promotion program on the physical activity of African American parents.,"This study examined the effects of a family-based health promotion intervention on the moderate-to-vigorous physical activity (MVPA), light physical activity, sedentary behavior, and fruit and vegetable intake of African American parents. Eighty-nine African American parents (41.5 ± 8.5 years; 92% females; 74% obese; 64% < $40 K income) and adolescents (12.5 ± 1.4 years; 61% girls; 48% obese) were randomized to a 6-week behavioral skills plus positive parenting and peer monitoring intervention grounded in social cognitive, self-determination, and family systems theories or a general health comparison program. Parents wore accelerometers for 7 days and completed three 24-h dietary recalls at baseline and post-intervention. Multilevel regression models (controlling for baseline variables) demonstrated a significantly greater increase in parent MVPA for those in the intervention versus comparison condition (b = 9.44, SE = 4.26, p < 0.05). There were no other significant effects. Family-based approaches that include African American parents and youth may increase parent MVPA and hold promise for preventing chronic diseases.",2018,"Multilevel regression models (controlling for baseline variables) demonstrated a significantly greater increase in parent MVPA for those in the intervention versus comparison condition (b = 9.44, SE = 4.26, p < 0.05).","['African American parents and youth', 'African American parents', 'Eighty-nine African American parents (41.5\u2009±\u20098.5\xa0years; 92% females; 74% obese; 64%\u2009<\u2009$40\xa0K income) and adolescents (12.5\u2009±\u20091.4\xa0years; 61% girls; 48% obese']","['behavioral skills plus positive parenting and peer monitoring intervention grounded in social cognitive, self-determination, and family systems theories or a general health comparison program', 'randomized family-based health promotion program', 'family-based health promotion intervention']","['moderate-to-vigorous physical activity (MVPA), light physical activity, sedentary behavior, and fruit and vegetable intake', 'parent MVPA']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0303276', 'cui_str': 'K-40 radioisotope'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0039154', 'cui_str': 'Systems Theory'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]",89.0,0.0135485,"Multilevel regression models (controlling for baseline variables) demonstrated a significantly greater increase in parent MVPA for those in the intervention versus comparison condition (b = 9.44, SE = 4.26, p < 0.05).","[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'St George', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street, Suite 1009, Miami, FL, 33136, USA. s.stgeorge@med.miami.edu.'}, {'ForeName': 'Dawn K', 'Initials': 'DK', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'M Lee', 'Initials': 'ML', 'LastName': 'Van Horn', 'Affiliation': 'Department of Individual, Family, and Community Education, College of Education, University of New Mexico, Albuquerque, NM, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-018-9926-7']
744,32078383,Relations between Early Childhood Paternal Depression and Preschool- and School-age Psychosocial Functioning.,"Objective : The present study used a longitudinal design to examine associations between paternal depressive symptoms in toddlerhood and children's psychosocial adjustment during the preschool and school-age periods. Maternal depressive symptoms and intervention status were tested as moderators of associations between paternal depressive symptoms and child maladjustment. Method : The sample ( n  = 264, 48% female, 62% White, 14% Black, 14% bi-racial, 11% another racial group, and 86% non-Hispanic/Latinx) represented a subsample of families from the Early Steps Multisite Study, a clinical randomized trial testing the effectiveness of the Family Check-Up among low-income families using Women, Infants, and Children Nutritional Supplement Services in three communities varied in urbanicity. Fathers and mothers reported their levels of depressive symptoms at child age 2, primary caregivers (mostly mothers) contributed measures of child adjustment at ages 5, 8.5, and 9.5, and teachers completed questionnaires about child adjustment at ages 8.5 and 9.5. Results : Direct relations were found between paternal depressive symptoms and primary caregivers' reports of children's preschool and school-age internalizing problems. Furthermore, higher levels of paternal depression were associated with higher levels of children's later adjustment problems at preschool-age when maternal depressive symptoms were mild or higher. The Family Check-Up attenuated relations between paternal depressive symptoms and children's internalizing problems at school-age. Conclusions : These findings have important implications for future research on preventing children's early-emerging problem behaviors at home, suggesting that addressing  paternal  depressive symptoms in early childhood may be an important intervention target, especially in the context of maternal depression.",2020,Direct relations were found between paternal depressive symptoms and primary caregivers' reports of children's preschool and school-age internalizing problems.,"[""paternal depressive symptoms in toddlerhood and children's psychosocial adjustment during the preschool and school-age periods"", 'sample ( n  =\xa0264, 48% female, 62% White, 14% Black, 14% bi-racial, 11% another racial group, and 86% non-Hispanic/Latinx) represented a subsample of families from the Early Steps Multisite Study', 'among low-income families using Women, Infants, and Children Nutritional Supplement Services in three communities varied in urbanicity']",['Family Check-Up'],"['paternal depression', 'depressive symptoms', 'Maternal depressive symptoms', 'paternal depressive symptoms']","[{'cui': 'C0337493', 'cui_str': 'Paternal (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0034510', 'cui_str': 'Racial Stocks'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0337493', 'cui_str': 'Paternal (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",,0.027698,Direct relations were found between paternal depressive symptoms and primary caregivers' reports of children's preschool and school-age internalizing problems.,"[{'ForeName': 'Julia S', 'Initials': 'JS', 'LastName': 'Feldman', 'Affiliation': 'Department of Psychology, University of Pittsburgh.'}, {'ForeName': 'Melvin N', 'Initials': 'MN', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of Virginia.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology, University of Pittsburgh.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2020.1723600']
745,18276017,Sequence of improvement in depressive symptoms across cognitive therapy and pharmacotherapy.,"BACKGROUND


The authors examined the patterns of improvement in cognitive and vegetative symptoms of major depression in individuals treated with cognitive therapy (CT) or pharmacotherapy (PT).
METHOD


Outpatients diagnosed with major depressive disorder (n=180) were randomized to receive either CT or PT. Cognitive and vegetative symptoms of major depression were measured by the Beck Depression Inventory-II at baseline and regularly throughout 16 weeks of treatment.
RESULTS


Multivariate hierarchical linear modeling demonstrated the same patterns of change over time for cognitive and vegetative symptoms within CT and within PT.
LIMITATIONS


Self-report measures may not be sufficiently specific to capture subtle differences in improvements between vegetative and cognitive symptoms.
CONCLUSIONS


These results are consistent with Beck's [Beck, A.T., 1984, November. Cognition and theory [Letter to the editor]. Arch. Gen. Psychiatry 41, 1112-1114.] hypothesis that CT and PT have a similar site of action, which when targeted, results in changes in both cognitive and vegetative features.",2008,"Cognitive and vegetative symptoms of major depression were measured by the Beck Depression Inventory-II at baseline and regularly throughout 16 weeks of treatment.
","['Outpatients diagnosed with major depressive disorder (n=180', 'Gen. Psychiatry 41, 1112-1114', 'individuals treated with cognitive therapy (CT) or pharmacotherapy (PT']",['CT or PT'],"['Cognitive and vegetative symptoms of major depression', 'depressive symptoms', 'change over time for cognitive and vegetative symptoms']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4521767', 'cui_str': 'US Military Commissioned Officer O10'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]",[],"[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0193126,"Cognitive and vegetative symptoms of major depression were measured by the Beck Depression Inventory-II at baseline and regularly throughout 16 weeks of treatment.
","[{'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Bhar', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, PA 19104, USA. sbhar@mail.med.upenn.edu.au'}, {'ForeName': 'Lois A', 'Initials': 'LA', 'LastName': 'Gelfand', 'Affiliation': ''}, {'ForeName': 'Sabine P', 'Initials': 'SP', 'LastName': 'Schmid', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gallop', 'Affiliation': ''}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'DeRubeis', 'Affiliation': ''}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Hollon', 'Affiliation': ''}, {'ForeName': 'Jay D', 'Initials': 'JD', 'LastName': 'Amsterdam', 'Affiliation': ''}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': ''}, {'ForeName': 'Aaron T', 'Initials': 'AT', 'LastName': 'Beck', 'Affiliation': ''}]",Journal of affective disorders,['10.1016/j.jad.2007.12.227']
746,31056855,Effects of Differential Food Patterns on the Pharmacokinetics of Enteric-Coated Mesalazine Tablets in the Same Cohort of Healthy Chinese Volunteers.,"This study aimed to simultaneously determine mesalazine (5-ASA) and its major metabolite N-Ac-5-ASA in the plasma and to evaluate the impact of different food patterns on the relative bioavailability and pharmacokinetics of a single oral dose of 5-ASA in healthy subjects. In this single-dose, open-label, 3-period, 3-treatment crossover study, the subjects received a single, oral dose of 500-mg enteric-coated mesalazine tablet together with either a low-fat or a high-fat breakfast or under fasting condition (reference). The pharmacokinetic parameters were determined by noncompartmental methods and analyzed with a linear mixed-effect model. The geometric least squares mean ratio for the area under the plasma concentration-time curve from zero to infinity of N-Ac-5-ASA was 1.05 (90% confidence interval [CI], 0.70-1.58) for high-fat/fasted condition and 1.06 (90%CI, 0.82-1.36) for low-fat/fasted condition. The least squares mean ratio of 5-ASA was 0.86 (90%CI, 0.65-1.14) for high-fat/fasted condition and 0.78 (90%CI, 0.60-1.02) for low-fat/fasted condition. All P values were >.05. The mean maximum plasma concentration and the time to reach the maximum plasma concentration of N-Ac-5-ASA were 2084 ng/mL, 8 hours; 2639 ng/mL, 11 hours, and 2409 ng/mL, 9 hours for fasted, high-fat, and low-fat, respectively. The values of 5-ASA were 1950 ng/mL, 7 hours; 2869 ng/mL, 9 hours; and 2837 ng/mL, 8 hours for fasted, high-fat, and low-fat condition. 5-ASA was well tolerated under all 3 conditions. Food delayed the absorption of 5-ASA, especially a high-fat meal. Therefore, enteric-coated mesalazine tablets should be taken before meals to avoid causing patients slow response and any effect of food on its efficacy.",2020,"The least squares mean ratio of 5-ASA was 0.86 (90%CI, 0.65-1.14) for high-fat/fasted condition and 0.78","['Healthy Chinese Volunteers', 'healthy subjects']","['500-mg enteric-coated mesalazine tablet together with either a low-fat or a high-fat breakfast or under fasting condition (reference', 'mesalazine (5-ASA', '5-ASA', 'Mesalazine Tablets']","['least squares mean ratio of 5-ASA', 'values of 5-ASA', 'mean maximum plasma concentration']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0127615', 'cui_str': 'mesalazine'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0127615', 'cui_str': 'mesalazine'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.105482,"The least squares mean ratio of 5-ASA was 0.86 (90%CI, 0.65-1.14) for high-fat/fasted condition and 0.78","[{'ForeName': 'Su-Hua', 'Initials': 'SH', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Shan-Shan', 'Initials': 'SS', 'LastName': 'Wei', 'Affiliation': 'Department of Pharmacy, Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Pharmacy, Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xiao-Mei', 'Initials': 'XM', 'LastName': 'Huang', 'Affiliation': 'Department of National Drug Clinical Trial Research Center, Xiangyya BoAi Rehabilitation Hospital, Changsha, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmacy, Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Xiang-Xin', 'Initials': 'XX', 'LastName': 'Wu', 'Affiliation': 'Department of Pharmacy, Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Hua-Lin', 'Initials': 'HL', 'LastName': 'Cai', 'Affiliation': 'Department of Pharmacy, Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Bi-Kui', 'Initials': 'BK', 'LastName': 'Zhang', 'Affiliation': 'Department of Pharmacy, Second Xiangya Hospital, Central South University, Changsha, China.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.696']
747,15556742,Implementing guidelines for smoking cessation: comparing the efforts of nurses and medical assistants.,"BACKGROUND


It is unclear how different types of intake clinicians (registered nurses [RNs], and less costly licensed practical nurses [LPNs] and medical assistants [MAs]) compare in the performance of smoking-cessation activities recommended in the Agency for Healthcare Research and Quality (AHRQ) smoking-cessation clinical practice guideline.
METHODS


A secondary analysis of data from a randomized controlled trial of guideline implementation was performed. Exit interviews of consecutive adult smokers who presented to nine primary care clinics for routine, non-emergency care were conducted during the period February 2000 to May 2001; a total of 1221 patients with adequate data were analyzed. Intake clinicians were surveyed prior to guideline training. Hierarchical logistic regression models were used to determine the association between type of intake clinician and performance of cessation counseling at the clinic visit, after adjustment for patient-level covariates, intake clinicians' characteristics, and study site.
RESULTS


Performance of all guideline-recommended counseling activities were significantly greater for all intake clinicians at test versus control sites. MAs were significantly less likely to assess willingness to quit (adjusted odds ratio [AOR]=0.4, 95% confidence interval [CI]=0.2-0.8, p =0.005) and tended to offer advice and assistance in quitting less often than RNs. Similar findings were observed for LPNs (AOR=0.5, 95% CI=0.3-1.0, p =0.03, for assessing willingness to quit). Subset analysis in subjects with complete survey data revealed that being seen by a MA was no longer associated with statistically significant differences in performance, after accounting for personal beliefs, self-efficacy, and role satisfaction in cessation counseling.
CONCLUSIONS


Although both MAs and LPNs showed marked improvements in performance in response to the guideline intervention, patients seen by these intake clinicians were less likely to receive guideline-recommended counseling, compared to those patients seen by RNs. Given their important role in the delivery of preventive care, MAs and LPNs should receive proper training in cessation counseling, should have strong physician and administrative support, and should be included in efforts to implement smoking-cessation guidelines in primary care.",2004,"MAs were significantly less likely to assess willingness to quit (adjusted odds ratio [AOR]=0.4, 95% confidence interval [CI]=0.2-0.8, p =0.005) and tended to offer advice and assistance in quitting less often than RNs.","['consecutive adult smokers who presented to nine primary care clinics for routine, non-emergency care were conducted during the period February 2000 to May 2001; a total of 1221 patients with adequate data were analyzed']",[],"['counseling activities', 'personal beliefs, self-efficacy, and role satisfaction', 'MAs', 'willingness to quit']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1527398', 'cui_str': 'Emergency Care'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}]",[],"[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",1221.0,0.0195855,"MAs were significantly less likely to assess willingness to quit (adjusted odds ratio [AOR]=0.4, 95% confidence interval [CI]=0.2-0.8, p =0.005) and tended to offer advice and assistance in quitting less often than RNs.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Katz', 'Affiliation': 'Division of General Internal Medicine, Department of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA. david-katz@uiowa.edu'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'Muehlenbruch', 'Affiliation': ''}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Fiore', 'Affiliation': ''}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of preventive medicine,[]
748,30957391,The influence of mean arterial pressure on the efficacy and safety of dual antiplatelet therapy in minor stroke or transient ischemic attack patients.,"Mean arterial pressure (MAP) is the strongest predictor of stroke. The combination of clopidogrel and aspirin within 24 hours after onset has been suggested by the Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events (CHANCE) study to be superior to aspirin alone. However, it is not clear whether poststroke blood pressure has an influence on the efficacy and safety of dual antiplatelet treatment. We have performed a post hoc analysis from the CHANCE trial. Patients were stratified into three groups based on MAP levels. Among patients with MAP <102 mm Hg, there was no significant difference in stroke recurrence between the clopidogrel-aspirin group and the aspirin group (7.7% vs 7.5%; hazard ratio [HR], 1.03; 95% confidence interval [CI], 0.73-1.45). However, compared to aspirin treatment, the clopidogrel-aspirin dual treatment was more effective at reducing the risk of stroke in patients with MAP ≥113 mm Hg (6.9% vs 12.3%, HR, 0.55; 95% CI, 0.39-0.78) or 102-113 mm Hg (9.5% vs 14.9%, HR, 0.62; 95% CI, 0.48-0.81). There was a significant interaction between MAP and antiplatelet therapy as it relates to stroke recurrence (P for interaction = 0.037), and a similar result was found for combined vascular events (P for interaction = 0.027). In conclusion, dual antiplatelet therapy may be more effective at reducing combined vascular events in patients with higher MAP after minor stroke or transient ischemic attack.",2019,"Hg (9.5% vs 14.9%, HR, 0.62; 95% CI, 0.48-0.81).","['patients with MAP <102\xa0mm', 'minor stroke or transient ischemic attack patients', 'patients with MAP ≥113\xa0mm', 'patients with higher MAP after minor stroke or transient ischemic attack']","['clopidogrel-aspirin', 'clopidogrel and aspirin', 'aspirin', 'dual antiplatelet therapy']","['stroke recurrence', 'risk of stroke', 'Mean arterial pressure (MAP', 'efficacy and safety', 'mean arterial pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0656201,"Hg (9.5% vs 14.9%, HR, 0.62; 95% CI, 0.48-0.81).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Fenghe', 'Initials': 'F', 'LastName': 'Du', 'Affiliation': 'Department of Cardiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13527']
749,30973207,A randomized controlled trial on the blood pressure-lowering effect of amlodipine and nifedipine-GITS in sustained hypertension.,"In a multicenter, randomized trial, we investigated whether the long half-time dihydropyridine calcium channel blocker amlodipine was more efficacious than the gastrointestinal therapeutic system (GITS) formulation of nifedipine in lowering ambulatory blood pressure (BP) in sustained hypertension (clinic systolic/diastolic BP 140-179/90-109 mm Hg and 24-hour systolic/diastolic BP ≥ 130/80 mm Hg). Eligible patients were randomly assigned to amlodipine 5-10 mg/day or nifedipine-GITS 30-60 mg/day. Ambulatory BP monitoring was performed for 24 hours at baseline and 4-week treatment and for 48 hours at 8-week treatment with a dose of medication missed on the second day. After 8-week treatment, BP was similarly reduced in the amlodipine (n = 257) and nifedipine-GITS groups (n = 248) for both clinic and ambulatory (24-hour systolic/diastolic BP 10.3/6.5 vs 10.9/6.3 mm Hg, P ≥ 0.24) measurements. However, after missing a dose of medication, ambulatory BP reductions were greater in the amlodipine than nifedipine-GITS group, with a significant (P ≤ 0.04) between-group difference in 24-hour (-1.2 mm Hg) and daytime diastolic BP (-1.5 mm Hg). In conclusion, amlodipine and nifedipine-GITS were efficacious in reducing 24-hour BP. When a dose of medication was missed, amlodipine became more efficacious than nifedipine-GITS.",2019,"However, after missing a dose of medication, ambulatory BP reductions were greater in the amlodipine than nifedipine-GITS group, with a significant (P ≤ 0.04) between-group difference in 24-hour (-1.2 mm Hg) and daytime diastolic BP (-1.5 mm Hg).","['Eligible patients', 'sustained hypertension (clinic systolic/diastolic BP 140-179/90-109\xa0mm', 'sustained hypertension']","['nifedipine-GITS', 'nifedipine', 'dihydropyridine calcium channel blocker amlodipine', 'amlodipine 5-10\xa0mg/day or nifedipine-GITS 30-60\xa0mg/day', 'amlodipine and nifedipine-GITS', 'amlodipine']","['daytime diastolic BP', '24-hour BP', 'ambulatory BP reductions', 'BP', 'ambulatory blood pressure (BP', 'Hg and 24-hour systolic/diastolic BP', 'Ambulatory BP monitoring']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0220821', 'cui_str': 'dihydropyridine'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",257.0,0.0861067,"However, after missing a dose of medication, ambulatory BP reductions were greater in the amlodipine than nifedipine-GITS group, with a significant (P ≤ 0.04) between-group difference in 24-hour (-1.2 mm Hg) and daytime diastolic BP (-1.5 mm Hg).","[{'ForeName': 'Qi-Fang', 'Initials': 'QF', 'LastName': 'Huang', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Shanghai Key Laboratory of Hypertension, Department of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chang-Sheng', 'Initials': 'CS', 'LastName': 'Sheng', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Shanghai Key Laboratory of Hypertension, Department of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Shanghai Key Laboratory of Hypertension, Department of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Dou', 'Affiliation': 'Jiangsu Province Hospital for Governmental Employees, Nanjing, China.'}, {'ForeName': 'Mei-Sheng', 'Initials': 'MS', 'LastName': 'Zheng', 'Affiliation': 'Wuhu Chinese Medicine Hospital, Wuhu, China.'}, {'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Zhu', 'Affiliation': 'Chongqing Hypertension Institute, Department of Hypertension and Endocrinology, Daping Hospital, The Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Ji-Guang', 'Initials': 'JG', 'LastName': 'Wang', 'Affiliation': 'Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Shanghai Key Laboratory of Hypertension, Department of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13543']
750,18245030,Antidepressant medications v. cognitive therapy in people with depression with or without personality disorder.,"BACKGROUND


There is conflicting evidence about comorbid personality pathology in depression treatments.
AIMS


To test the effects of antidepressant drugs and cognitive therapy in people with depression distinguished by the presence or absence of personality disorder.
METHOD


Random assignment of 180 out-patients with depression to 16 weeks of antidepressant medication or cognitive therapy. Random assignment of medication responders to continued medication or placebo, and comparison with cognitive therapy responders over a 12-month period.
RESULTS


Personality disorder status led to differential response at 16 weeks; 66% v. 44% (antidepressants v. cognitive therapy respectively) for people with personality disorder, and 49% v. 70% (antidepressants v. cognitive therapy respectively) for people without personality disorder. For people with personality disorder, sustained response rates over the 12-month follow-up were nearly identical (38%) in the prior cognitive therapy and continuation-medication treatment arms. People with personality disorder withdrawn from medication evidenced the lowest sustained response rate (6%). Despite the poor response of people with personality disorder to cognitive therapy, nearly all those who did respond sustained their response.
CONCLUSIONS


Comorbid personality disorder was associated with differential initial response rates and sustained response rates for two well-validated treatments for depression.",2008,"CONCLUSIONS


Comorbid personality disorder was associated with differential initial response rates and sustained response rates for two well-validated treatments for depression.","['people with depression distinguished by the presence or absence of personality disorder', '180 out-patients with depression to 16 weeks of', 'people with depression with or without personality disorder']","['antidepressant drugs and cognitive therapy', 'antidepressant medication or cognitive therapy', 'placebo', 'Antidepressant medications v. cognitive therapy']",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0031212', 'cui_str': 'Personality Disorders'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],180.0,0.0342901,"CONCLUSIONS


Comorbid personality disorder was associated with differential initial response rates and sustained response rates for two well-validated treatments for depression.","[{'ForeName': 'Jay C', 'Initials': 'JC', 'LastName': 'Fournier', 'Affiliation': 'Department of Psychology, University of Pennsylvania, Philadelphia, PA 19104-6196, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'DeRubeis', 'Affiliation': ''}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gallop', 'Affiliation': ''}, {'ForeName': 'Jay D', 'Initials': 'JD', 'LastName': 'Amsterdam', 'Affiliation': ''}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Hollon', 'Affiliation': ''}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.bp.107.037234']
751,31628873,Clinical and tomographic comparison of dental implants placed by guided virtual surgery versus conventional technique: A split-mouth randomized clinical trial.,"AIM


Our objective was to compare guided virtual surgery to conventional surgery in terms of angular deviation of single dental implants placed in the posterior mandible.
MATERIALS AND METHODS


Patients with bilateral homologous single teeth missing in the posterior mandible were eligible for this split-mouth randomized clinical trial. Cone beam computed tomography (CBCT) was performed for virtual planning of implant position and manufacturing of the stereolithographic guides. One week after the surgery, a second CBCT scan was superimposed to the initial planning. Primary endpoint was the angular deviation between virtual and clinical implant position. Secondary endpoints were linear deviations and patient-reported outcomes collected with a questionnaire.
RESULTS


Data from 12 patients were available for analysis. Angular deviation was significantly lower using stereolithographic guides as compared to conventional guides (2.2 ± 1.1° vs. 3.5 ± 1.6°, p = .042). Linear deviations were similar for both techniques in the coronal (2.34 ± 1.01 vs. 1.93 ± 0.95 mm) and apical (2.53 ± 1.11 vs. 2.19 ± 1.00 mm) dimensions (p ˃ .05). The selection of the surgical technique had no significant impact on the patient-reported outcomes.
CONCLUSION


Our data suggest that the angular discrepancy between the virtual and the clinical implant position is slightly lower when using stereolithographic guides as compared to conventional guides.",2020,"Angular deviation was significantly lower using stereolithographic guides as compared to conventional guides (2.2±1.1° vs 3.5±1.6°, p=0.042).","['Patients with bilateral homologous single teeth missing in the posterior mandible were eligible for this split-mouth randomized clinical trial', '12 patients were available for analysis']","['Cone beam computed tomography (CBCT', 'dental implants placed by guided virtual surgery versus conventional technique', 'guided virtual surgery to conventional surgery']","['angular deviation between virtual and clinical implant position', 'linear deviations and patient-reported outcomes collected with a questionnaire', 'Angular deviation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0457756', 'cui_str': 'Tooth absent (finding)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0024687', 'cui_str': 'Mandible'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0206034', 'cui_str': 'Clinical Trials, Randomized'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1956110', 'cui_str': 'Cone-Beam Computerized Tomography'}, {'cui': 'C0011373', 'cui_str': 'Dental Implants'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.147607,"Angular deviation was significantly lower using stereolithographic guides as compared to conventional guides (2.2±1.1° vs 3.5±1.6°, p=0.042).","[{'ForeName': 'Gabriel L', 'Initials': 'GL', 'LastName': 'Magrin', 'Affiliation': 'Department of Dentistry, Center of Education and Research on Dental Implants, Federal University of Santa Catarina / UFSC, Florianopolis, Brazil.'}, {'ForeName': 'Stela N F', 'Initials': 'SNF', 'LastName': 'Rafael', 'Affiliation': 'Faculty of Dentistry, São Leopoldo Mandic, Campinas, Brazil.'}, {'ForeName': 'Bernardo B', 'Initials': 'BB', 'LastName': 'Passoni', 'Affiliation': 'Department of Dentistry, Center of Education and Research on Dental Implants, Federal University of Santa Catarina / UFSC, Florianopolis, Brazil.'}, {'ForeName': 'Ricardo S', 'Initials': 'RS', 'LastName': 'Magini', 'Affiliation': 'Department of Dentistry, Center of Education and Research on Dental Implants, Federal University of Santa Catarina / UFSC, Florianopolis, Brazil.'}, {'ForeName': 'Cesar A M', 'Initials': 'CAM', 'LastName': 'Benfatti', 'Affiliation': 'Department of Dentistry, Center of Education and Research on Dental Implants, Federal University of Santa Catarina / UFSC, Florianopolis, Brazil.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Gruber', 'Affiliation': 'Department of Oral Biology, Dental School of the Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daiane C', 'Initials': 'DC', 'LastName': 'Peruzzo', 'Affiliation': 'Faculty of Dentistry, São Leopoldo Mandic, Campinas, Brazil.'}]",Journal of clinical periodontology,['10.1111/jcpe.13211']
752,31047394,Age-Related Macular Degeneration and Mortality in the Age-Related Eye Disease Study (AREDS): The Effect of Sex and Time.,"PURPOSE


Age-related macular degeneration (AMD) shares similar risk factors and pathogeneses with cardiovascular diseases (CVDs). Epidemiologic studies over the past 2 decades analyzing the association between AMD and all-cause and CVD-specific mortality have failed to yield conclusive results. The purpose of this analysis is to investigate the sex-specific association between AMD and all-cause and CVD-specific mortality, and to assess whether duration of follow-up alters the strength of association.
DESIGN


The database of Genotypes and Phenotypes (dbGaP) data set for the Age-Related Eye Disease Study, a randomized clinical trial of high-dose antioxidants in AMD prevention, with participants enrolled from 1992 to 1998 and followed through 2005, was used in the analysis.
PARTICIPANTS


There were 4757 Age-Related Eye Disease Study participants aged 55 through 80 years (mean, 69.4 years; 44.1% male) recruited from 11 retinal specialty clinics. Participants had standard Age-Related Eye Disease Study AMD categories (category 1, n = 1117; category 2, n = 1062; category 3, n = 1621; category 4, n = 957).
METHODS


The sex-specific adjusted hazard ratio (HR adj ) between baseline AMD and all-cause and CVD-specific mortality was determined at multiple time points (e.g., 5, 7, 10, and all years), adjusting for age, race, diabetes, hypertension, angina, cancer, smoking, obesity, clinical trial antioxidant treatment category, and education.
MAIN OUTCOME MEASURES


Sex-specific all-cause and CVD-specific mortality.
RESULTS


Mean follow-up was 9.6 years (range, 0.5-12.5 years), with 1087 deaths (category 1, n = 197 [17.6%]; category 2, n = 200 [18.8%]; category 3, n = 356 [22.0%]; category 4, n = 326 [34.1%]). Sex-stratified models demonstrated sex differences; in women, a significant association between AMD category 4 and all-cause mortality existed compared with category 1 at each period (HR adj , 1.5-2.3; all P ≤ 0.005); similar category 4 findings were present with CVD-specific mortality, strengthening with shorter periods (HR adj , 1.9-4.6; all P ≤ 0.01). Among men, a significant association between all AMD stages and all-cause (HR adj , 1.5-2.3; all P ≤ 0.05) and CVD-specific mortality (HR adj , 1.6-4.0; all P ≤ 0.05) existed for nearly all periods.
CONCLUSIONS


Substantial late AMD cases and deaths exceed those in previous population-based studies to better test mortality-related hypotheses. Age-related macular degeneration was significantly associated with all-cause and CVD-specific mortality. Relationships weakened over a longer duration of follow-up, and sex seems to modify the association. Future analyses are warranted to interrogate the possible clinical usefulness of these relationships.",2017,"Sex-stratified models demonstrated sex differences; in women, a significant association between AMD category 4 and all-cause mortality existed compared with category 1 at each period (HR adj , 1.5-2.3; all P ≤ 0.005); similar category 4 findings were present with CVD-specific mortality, strengthening with shorter periods (HR adj , 1.9-4.6; all P ≤ 0.01).","['participants enrolled from 1992 to 1998 and followed through 2005, was used in the analysis', 'Participants had standard Age-Related Eye Disease Study AMD categories (category 1, n\xa0= 1117; category 2, n\xa0= 1062; category 3, n\xa0= 1621; category 4, n\xa0= 957', 'Age-Related Macular Degeneration and Mortality in the Age-Related Eye Disease Study (AREDS', '4757 Age-Related Eye Disease Study participants aged 55 through 80 years (mean, 69.4 years; 44.1% male) recruited from 11 retinal specialty clinics', 'The sex-specific adjusted hazard ratio (HR adj ) between baseline AMD and all-cause and CVD-specific mortality was determined at multiple time points (e.g., 5, 7, 10, and all years), adjusting for age, race, diabetes, hypertension, angina, cancer, smoking, obesity, clinical trial antioxidant treatment category, and education']",[],"['CVD-specific mortality', 'Sex-specific all-cause and CVD-specific mortality', 'Age-related macular degeneration']","[{'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0015397', 'cui_str': 'Eye Diseases'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],"[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0242383', 'cui_str': 'Maculopathy, Age-Related'}]",4757.0,0.0271054,"Sex-stratified models demonstrated sex differences; in women, a significant association between AMD category 4 and all-cause mortality existed compared with category 1 at each period (HR adj , 1.5-2.3; all P ≤ 0.005); similar category 4 findings were present with CVD-specific mortality, strengthening with shorter periods (HR adj , 1.9-4.6; all P ≤ 0.01).","[{'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Joslin', 'Affiliation': 'Illinois Eye and Ear Infirmary, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, Illinois; Epidemiology and Biostatistics, University of Illinois at Chicago, Chicago, Illinois. Electronic address: charjosl@uic.edu.'}, {'ForeName': 'Thasarat S', 'Initials': 'TS', 'LastName': 'Vajaranant', 'Affiliation': 'Illinois Eye and Ear Infirmary, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Ulanski', 'Affiliation': 'Illinois Eye and Ear Infirmary, Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, Illinois.'}]",Ophthalmology. Retina,['10.1016/j.oret.2016.09.004']
753,32117242,Effect of Optimized Immunosuppression (Including Rituximab) on Anti-Donor Alloresponses in Patients With Chronically Rejecting Renal Allografts.,"RituxiCAN-C4 combined an open-labeled randomized controlled trial (RCT) in 7 UK centers to assess whether rituximab could stabilize kidney function in patients with chronic rejection, with an exploratory analysis of how B cell-depletion influenced T cell anti-donor responses relative to outcome. Between January 2007 and March 2015, 59 recruits were enrolled after screening, 23 of whom consented to the embedded RCT. Recruitment was halted when in a pre-specified per protocol interim analysis, the RCT was discovered to be significantly underpowered. This report therefore focuses on the exploratory analysis, in which we confirmed that when B cells promoted CD4+ anti-donor IFNγ production assessed by ELISPOT, this associated with inferior clinical outcome; these patterns were inhibited by optimized immunosuppression but not rituximab. B cell suppression of IFNγ production, which associated with number of transitional B cells and correlated with slower declines in kidney function was abolished by rituximab, which depleted transitional B cells for prolonged periods. We conclude that in this patient population, optimized immunosuppression but not rituximab promotes anti-donor alloresponses associated with favorable outcomes.  Clinical Trial Registration:  Registered with EudraCT (2006-002330-38) and www.ClinicalTrials.gov, identifier: NCT00476164.",2020,"B cell suppression of IFNγ production, which associated with number of transitional B cells and correlated with slower declines in kidney function was abolished by rituximab, which depleted transitional B cells for prolonged periods.","['Between January 2007 and March 2015, 59 recruits were enrolled after screening, 23 of whom consented to the embedded RCT', 'Patients', 'patients with chronic rejection', '2006-002330-38) and www']","['Optimized Immunosuppression (Including Rituximab', 'rituximab', 'EudraCT', 'RituxiCAN-C4 combined']","['CD4+ anti-donor IFNγ production', 'kidney function', 'number of transitional B cells']","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}]","[{'cui': 'C0021080', 'cui_str': 'Immunosuppression (Physiology)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0033268'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1512631', 'cui_str': 'Transitional B-Cells'}]",,0.0792756,"B cell suppression of IFNγ production, which associated with number of transitional B cells and correlated with slower declines in kidney function was abolished by rituximab, which depleted transitional B cells for prolonged periods.","[{'ForeName': 'Kin Yee', 'Initials': 'KY', 'LastName': 'Shiu', 'Affiliation': ""Department of Inflammation Biology, MRC Centre for Transplantation, Guy's Hospital, King's College London, London, United Kingdom.""}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Stringer', 'Affiliation': ""Biostatistics and Health Informatics, The Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'McLaughlin', 'Affiliation': ""Department of Inflammation Biology, MRC Centre for Transplantation, Guy's Hospital, King's College London, London, United Kingdom.""}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Shaw', 'Affiliation': 'Viapath Analytics LLP, London, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Brookes', 'Affiliation': 'Histocompatibility and Immunogenetics, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Burton', 'Affiliation': ""Department of Inflammation Biology, MRC Centre for Transplantation, Guy's Hospital, King's College London, London, United Kingdom.""}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wilkinson', 'Affiliation': ""Department of Inflammation Biology, MRC Centre for Transplantation, Guy's Hospital, King's College London, London, United Kingdom.""}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Douthwaite', 'Affiliation': ""Department of Inflammation Biology, MRC Centre for Transplantation, Guy's Hospital, King's College London, London, United Kingdom.""}, {'ForeName': 'Tjir-Li', 'Initials': 'TL', 'LastName': 'Tsui', 'Affiliation': ""Department of Inflammation Biology, MRC Centre for Transplantation, Guy's Hospital, King's College London, London, United Kingdom.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Mclean', 'Affiliation': 'Imperial College Renal and Transplant Centre, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hilton', 'Affiliation': ""Department of Nephrology and Transplantation, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Griffin', 'Affiliation': 'Department of Nephrology, University Hospital of Wales, Cardiff, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Geddes', 'Affiliation': 'Renal Unit, Western Infirmary, NHS Greater Glasgow and Clyde Trust, Glasgow, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ball', 'Affiliation': 'Department of Nephrology, University Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Baker', 'Affiliation': ""Renal Unit, St. James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Roufosse', 'Affiliation': 'Histocompatibility and Immunogenetics, Imperial College Healthcare NHS Trust, London, United Kingdom.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Horsfield', 'Affiliation': ""Department of Histopathology, Guy's and St. Thomas' NHS Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Dorling', 'Affiliation': ""Department of Inflammation Biology, MRC Centre for Transplantation, Guy's Hospital, King's College London, London, United Kingdom.""}]",Frontiers in immunology,['10.3389/fimmu.2020.00079']
754,31725021,"A Prospective, Randomized, Double-Blinded Study of the Effect of Intravenous Ondansetron on the Effective Dose in 50% of Subjects of Prophylactic Phenylephrine Infusions for Preventing Spinal Anesthesia-Induced Hypotension During Cesarean Delivery.","BACKGROUND


Ondansetron has been shown to reduce the incidence of hypotension and vasopressor requirement during spinal anesthesia for obstetric and nonobstetric surgery. However, the magnitude of this effect has not been fully quantified. In this parallel-group, randomized, double-blinded study, we determined the effective dose in 50% of subjects (ED50) of a prophylactic phenylephrine infusion for preventing hypotension in patients who received a single dose of intravenous ondansetron 4 mg or saline control before combined spinal-epidural anesthesia for elective cesarean delivery. ED50 values obtained were compared to estimate the effect of ondansetron versus placebo on vasopressor requirement.
METHODS


Sixty parturients were randomly assigned to receive ondansetron (group O) or saline control (group C) 10 minutes before positioning for induction of spinal anesthesia. A prophylactic phenylephrine infusion was used to prevent hypotension. The first patient in each group received a phenylephrine infusion at the rate of 0.5 µg/kg/min. The infusion rate for each subsequent patient was varied with increments or decrements of 0.05 µg/kg/min based on the response of the previous patient, and the effective dose of the phenylephrine infusion for preventing hypotension in 50% of patients (ED50) was calculated for each group and compared using up-down sequential analysis. Probit regression was applied as a backup and sensitivity analysis was used to compare ED50 values for phenylephrine between groups by comparing calculated relative mean potency.
RESULTS


The ED50 (mean [95% confidence interval (CI)]) of the rate of phenylephrine infusion was lower in group O (0.24 µg/kg/min [0.10-0.38 µg/kg/min]) compared with group C (0.32 µg/kg/min [0.14-0.47 µg/kg/min]) (P < .001). The total consumption of phenylephrine (mean ± standard deviation [SD]) until delivery was lower in group O (316.5 ± 25.9 µg) than in group C (387.7 ± 14.7 µg, P = .02). The estimate of relative median potency for phenylephrine for group O versus group C was 0.74 (95% CI, 0.37-0.95).
CONCLUSIONS


Under the conditions of this study, intravenous ondansetron 4 mg reduced the ED50 of a prophylactic phenylephrine infusion by approximately 26% in patients undergoing cesarean delivery under combined spinal-epidural anesthesia.",2020,"The total consumption of phenylephrine (mean ± standard deviation [SD]) until delivery was lower in group O (316.5 ± 25.9 µg) than in group C (387.7 ± 14.7 µg, P = .02).","['before combined spinal-epidural anesthesia for elective cesarean delivery', '50% of Subjects of Prophylactic Phenylephrine Infusions for Preventing Spinal Anesthesia-Induced Hypotension During Cesarean Delivery', 'patients undergoing cesarean delivery under combined spinal-epidural anesthesia', 'Sixty parturients']","['prophylactic phenylephrine infusion', 'ondansetron', 'phenylephrine infusion', 'ondansetron 4 mg or saline control', 'Intravenous Ondansetron', 'phenylephrine', 'placebo', 'saline control', 'Ondansetron']","['rate of phenylephrine infusion', 'total consumption of phenylephrine (mean ± standard deviation [SD]) until delivery', 'hypotension', 'infusion rate', 'relative median potency']","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0020650', 'cui_str': 'Hypotension, Induced'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C1123367', 'cui_str': 'Ondansetron 4 MG'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.512375,"The total consumption of phenylephrine (mean ± standard deviation [SD]) until delivery was lower in group O (316.5 ± 25.9 µg) than in group C (387.7 ± 14.7 µg, P = .02).","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xiao', 'Affiliation': 'From the Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing City, China.'}, {'ForeName': 'Changna', 'Initials': 'C', 'LastName': 'Wei', 'Affiliation': 'From the Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing City, China.'}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Chang', 'Affiliation': 'From the Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing City, China.'}, {'ForeName': 'Yinfa', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Anesthesia, Jiaxing University Affiliated Women and Children Hospital, Jiaxing City, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Xue', 'Affiliation': 'Department of Obstetrics, Jiaxing University Affiliated Women and Children Hospital, Jiaxing City, China.'}, {'ForeName': 'Huaxiang', 'Initials': 'H', 'LastName': 'Shen', 'Affiliation': 'Department of Obstetrics, Jiaxing University Affiliated Women and Children Hospital, Jiaxing City, China.'}, {'ForeName': 'Warwick D', 'Initials': 'WD', 'LastName': 'Ngan Kee', 'Affiliation': 'Department of Anesthesiology, Sidra Medicine, Doha, Qatar.'}, {'ForeName': 'Xinzhong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004534']
755,31033011,Sample size considerations for stratified cluster randomization design with binary outcomes and varying cluster size.,"Stratified cluster randomization trials (CRTs) have been frequently employed in clinical and healthcare research. Comparing with simple randomized CRTs, stratified CRTs reduce the imbalance of baseline prognostic factors among different intervention groups. Due to the popularity, there has been a growing interest in methodological development on sample size estimation and power analysis for stratified CRTs; however, existing work mostly assumes equal cluster size within each stratum and uses multilevel models. Clusters are often naturally formed with random sizes in CRTs. With varying cluster size, commonly used ad hoc approaches ignore the variability in cluster size, which may underestimate (overestimate) the required number of clusters for each group per stratum and lead to underpowered (overpowered) clinical trials. We propose closed-form sample size formulas for estimating the required total number of subjects and for estimating the number of clusters for each group per stratum, based on Cochran-Mantel-Haenszel statistic for stratified cluster randomization design with binary outcomes, accounting for both clustering and varying cluster size. We investigate the impact of various design parameters on the relative change in the required number of clusters for each group per stratum due to varying cluster size. Simulation studies are conducted to evaluate the finite-sample performance of the proposed sample size method. A real application example of a pragmatic stratified CRT of a triad of chronic kidney disease, diabetes, and hypertension is presented for illustration.",2019,We investigate the impact of various design parameters on the relative change in the required number of clusters for each group per stratum due to varying cluster size.,[],[],[],[],[],[],,0.0907641,We investigate the impact of various design parameters on the relative change in the required number of clusters for each group per stratum due to varying cluster size.,"[{'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Division of Biostatistics, Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Division of Biostatistics, Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Chul', 'Initials': 'C', 'LastName': 'Ahn', 'Affiliation': 'Division of Biostatistics, Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas.'}]",Statistics in medicine,['10.1002/sim.8175']
756,30704260,Early Use of Norepinephrine in Septic Shock Resuscitation (CENSER). A Randomized Trial.,"Rationale:  Recent retrospective evidence suggests the efficacy of early norepinephrine administration during resuscitation; however, prospective data to support this assertion are scarce.  Objectives:  To conduct a phase II trial evaluating the hypothesis that early low-dose norepinephrine in adults with sepsis with hypotension increases shock control by 6 hours compared with standard care.  Methods:  This single-center, randomized, double-blind, placebo-controlled clinical trial was conducted at Siriraj Hospital, Bangkok, Thailand. The study enrolled 310 adults diagnosed with sepsis with hypotension. The patients were randomly divided into two groups: early norepinephrine ( n  = 155) and standard treatment ( n  = 155). The primary outcome was shock control rate (defined as achievement of mean arterial blood pressure ≥65 mm Hg, with urine flow ≥0.5 ml/kg/h for 2 consecutive hours, or decreased serum lactate ≥10% from baseline) by 6 hours after diagnosis.  Measurements and Main Results:  The patients in both groups were well matched in background characteristics and disease severity. Median time from emergency room arrival to norepinephrine administration was significantly shorter in the early norepinephrine group (93 vs. 192 min;  P  < 0.001). Shock control rate by 6 hours was significantly higher in the early norepinephrine group (118/155 [76.1%] vs. 75/155 [48.4%];  P  < 0.001). The 28-day mortality was not different between groups: 24/155 (15.5%) in the early norepinephrine group versus 34/155 (21.9%) in the standard treatment group ( P  = 0.15). The early norepinephrine group was associated with lower incidences of cardiogenic pulmonary edema (22/155 [14.4%] vs. 43/155 [27.7%];  P  = 0.004) and new-onset arrhythmia (17/155 [11%] vs. 31/155 [20%];  P  = 0.03).  Conclusions:  Early norepinephrine was significantly associated with increased shock control by 6 hours. Further studies are needed before this approach is introduced in clinical resuscitation practice. Clinical trial registered with www.clinicaltrials.gov (NCT01945983) (CENSER trial).",2019,The 28-day mortality was not different between groups: 24/155 (15.5%) in the early norepinephrine group versus 34/155 (21.9%) in the standard treatment group ( P  = 0.15).,"['adults with sepsis with hypotension increases shock control by 6 hours compared with standard care', '310 adults diagnosed with sepsis with hypotension']","['norepinephrine ( n \u2009=\u2009155) and standard treatment', 'Norepinephrine', 'norepinephrine', 'placebo']","['shock control rate (defined as achievement of mean arterial blood pressure ≥65 mm Hg, with urine flow ≥0.5 ml/kg/h for 2 consecutive hours, or decreased serum lactate', 'Median time from emergency room arrival to norepinephrine administration', 'Shock control rate', '28-day mortality', 'shock control', 'cardiogenic pulmonary edema', 'new-onset arrhythmia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0042037'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0398350', 'cui_str': 'Acute cardiogenic pulmonary edema'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0003811', 'cui_str': 'Arrhythmia'}]",310.0,0.228775,The 28-day mortality was not different between groups: 24/155 (15.5%) in the early norepinephrine group versus 34/155 (21.9%) in the standard treatment group ( P  = 0.15).,"[{'ForeName': 'Chairat', 'Initials': 'C', 'LastName': 'Permpikul', 'Affiliation': '1 Department of Medicine.'}, {'ForeName': 'Surat', 'Initials': 'S', 'LastName': 'Tongyoo', 'Affiliation': '1 Department of Medicine.'}, {'ForeName': 'Tanuwong', 'Initials': 'T', 'LastName': 'Viarasilpa', 'Affiliation': '1 Department of Medicine.'}, {'ForeName': 'Thavinee', 'Initials': 'T', 'LastName': 'Trainarongsakul', 'Affiliation': '1 Department of Medicine.'}, {'ForeName': 'Tipa', 'Initials': 'T', 'LastName': 'Chakorn', 'Affiliation': '2 Department of Emergency Medicine, and.'}, {'ForeName': 'Suthipol', 'Initials': 'S', 'LastName': 'Udompanturak', 'Affiliation': '3 Office of Research and Development, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201806-1034OC']
757,31868987,"Effects of acupuncture on obstructive sleep apnea severity, blood pressure control and quality of life in patients with hypertension: A randomized controlled trial.","Obstructive sleep apnea (OSA) is a common condition among patients with hypertension and treatment with continuous positive airway pressure (CPAP) can decrease blood pressure (BP). However, CPAP is not well tolerated by a significant proportion of patients. The authors investigated the effects of acupuncture on OSA severity and BP control in patients with hypertension. Hypertensive patients with mild to moderate OSA (apnea-hypopnea index, 5-30 events/hr) were randomly assigned to receive acupuncture or sham-acupuncture treatment. Patients were assessed at baseline and after 10 acupuncture sessions using polysomnography, 24-hr ambulatory BP monitoring and a quality of life questionnaire. Forty-four patients (34% men; mean age, 57.0 ± 5.4 years; body mass index, 29.6 ± 3.2 kg/m 2  ; apnea-hypopnea index, 16.3 ± 6.7 events/hr) completed the study. There were no differences in pre-post-intervention apnea-hypopnea index, daytime or nocturnal BP, or quality of life between the acupuncture and sham-acupuncture groups (p > .05). Acupuncture therapy in hypertensive patients with OSA did not reduce OSA severity, daytime or nocturnal BP, or quality of life.",2020,"There were no differences in pre-post-intervention apnea-hypopnea index, daytime or nocturnal BP, or quality of life between the acupuncture and sham-acupuncture groups (p > .05).","['Forty-four patients (34% men; mean age, 57.0\xa0±\xa05.4\xa0years; body mass index, 29.6\xa0±\xa03.2\xa0kg/m 2  ; apnea-hypopnea index, 16.3\xa0±\xa06.7\xa0events/hr) completed the study', 'patients with hypertension', 'hypertensive patients with OSA', 'Hypertensive patients with mild to moderate OSA (apnea-hypopnea index, 5-30\xa0events/hr', 'patients with hypertension and treatment with continuous positive airway pressure (CPAP']","['acupuncture or sham-acupuncture treatment', 'Acupuncture therapy', 'CPAP', 'acupuncture']","['OSA severity, daytime or nocturnal BP, or quality of life', 'pre-post-intervention apnea-hypopnea index, daytime or nocturnal BP, or quality of life', 'obstructive sleep apnea severity, blood pressure control and quality of life', 'blood pressure (BP', 'polysomnography, 24-hr ambulatory BP monitoring and a quality of life questionnaire', 'OSA severity and BP control', 'Obstructive sleep apnea (OSA']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture Treatment'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",44.0,0.0248392,"There were no differences in pre-post-intervention apnea-hypopnea index, daytime or nocturnal BP, or quality of life between the acupuncture and sham-acupuncture groups (p > .05).","[{'ForeName': 'Marcus Vinícius F P', 'Initials': 'MVFP', 'LastName': 'Silva', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Thais C', 'Initials': 'TC', 'LastName': 'Lustosa', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Victor J', 'Initials': 'VJ', 'LastName': 'Arai', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Tarcya L G', 'Initials': 'TLG', 'LastName': 'Couto Patriota', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Maria P F', 'Initials': 'MPF', 'LastName': 'Lira', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Ozeas L', 'Initials': 'OL', 'LastName': 'Lins-Filho', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Sintya T', 'Initials': 'ST', 'LastName': 'Chalegre', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Kamilla', 'Initials': 'K', 'LastName': 'B B A S', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Isaac V', 'Initials': 'IV', 'LastName': 'Secundo', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}, {'ForeName': 'Rodrigo P', 'Initials': 'RP', 'LastName': 'Pedrosa', 'Affiliation': 'Sleep and Heart Laboratory, Pronto Socorro Cardiologico de Pernambuco (PROCAPE) da Universidade de Pernambuco, Recife, Brazil.'}]",Journal of sleep research,['10.1111/jsr.12954']
758,29864732,Telephone-based mindfulness training to reduce stress in women with myocardial infarction: Rationale and design of a multicenter randomized controlled trial.,"BACKGROUND


Elevated stress is associated with adverse cardiovascular disease outcomes and accounts in part for the poorer recovery experienced by women compared with men after myocardial infarction (MI). Psychosocial interventions improve outcomes overall but are less effective for women than for men with MI, suggesting the need for different approaches. Mindfulness-based cognitive therapy (MBCT) is an evidence-based intervention that targets key psychosocial vulnerabilities in women including rumination (i.e., repetitive negative thinking) and low social support. This article describes the rationale and design of a multicenter randomized controlled trial to test the effects of telephone-delivered MBCT (MBCT-T) in women with MI.
METHODS


We plan to randomize 144 women reporting elevated perceived stress at least two months after MI to MBCT-T or enhanced usual care (EUC), which each involve eight weekly telephone sessions. Perceived stress and a set of patient-centered health outcomes and potential mediators will be assessed before and after the 8-week telephone programs and at 6-month follow-up. We will test the hypothesis that MBCT-T will be associated with greater 6-month improvements in perceived stress (primary outcome), disease-specific health status, quality of life, depression and anxiety symptoms, and actigraphy-based sleep quality (secondary outcomes) compared with EUC. Changes in mindfulness, rumination and perceived social support will be evaluated as potential mediators in exploratory analyses.
CONCLUSIONS


If found to be effective, this innovative, scalable intervention may be a promising secondary prevention strategy for women with MI experiencing elevated perceived stress.",2018,"Psychosocial interventions improve outcomes overall but are less effective for women than for men with MI, suggesting the need for different approaches.","['women with MI experiencing elevated perceived stress', '144 women reporting elevated perceived stress at least two months after MI to', 'women with myocardial infarction', 'women with MI']","['Telephone-based mindfulness training', 'telephone-delivered MBCT (MBCT-T', 'Psychosocial interventions', 'MBCT-T or enhanced usual care (EUC', 'Mindfulness-based cognitive therapy (MBCT']","['disease-specific health status, quality of life, depression and anxiety symptoms, and actigraphy-based sleep quality']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0034380'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",144.0,0.143601,"Psychosocial interventions improve outcomes overall but are less effective for women than for men with MI, suggesting the need for different approaches.","[{'ForeName': 'Tanya M', 'Initials': 'TM', 'LastName': 'Spruill', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY. Electronic address: Tanya.Spruill@nyumc.org.'}, {'ForeName': 'Harmony R', 'Initials': 'HR', 'LastName': 'Reynolds', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Victoria Vaughan', 'Initials': 'VV', 'LastName': 'Dickson', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, NY.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Shallcross', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Pallavi D', 'Initials': 'PD', 'LastName': 'Visvanathan', 'Affiliation': 'Manhattan Center for Mindfulness-Based Cognitive Behavioral Therapy, New York, NY.'}, {'ForeName': 'Chorong', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, NY.'}, {'ForeName': 'Jolaade', 'Initials': 'J', 'LastName': 'Kalinowski', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Judith S', 'Initials': 'JS', 'LastName': 'Hochman', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Glenn I', 'Initials': 'GI', 'LastName': 'Fishman', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine, NYU School of Medicine, New York, NY.'}, {'ForeName': 'Gbenga', 'Initials': 'G', 'LastName': 'Ogedegbe', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, NY.'}]",American heart journal,['10.1016/j.ahj.2018.03.028']
759,31695168,Intrinsic connectomes are a predictive biomarker of remission in major depressive disorder.,"Although major depressive disorder (MDD) is associated with altered functional coupling between disparate neural networks, the degree to which such measures are ameliorated by antidepressant treatment is unclear. It is also unclear whether functional connectivity can be used as a predictive biomarker of treatment response. Here, we used whole-brain functional connectivity analysis to identify neural signatures of remission following antidepressant treatment, and to identify connectomic predictors of treatment response. 163 MDD and 62 healthy individuals underwent functional MRI during pre-treatment baseline and 8-week follow-up sessions. Patients were randomized to escitalopram, sertraline or venlafaxine-XR antidepressants and assessed at follow-up for remission. Baseline measures of intrinsic functional connectivity between each pair of 333 regions were analyzed to identify pre-treatment connectomic features that distinguish remitters from non-remitters. We then interrogated these connectomic differences to determine if they changed post-treatment, distinguished patients from controls, and were modulated by medication type. Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks. This baseline hypo-connectivity for non-remitters also distinguished them from controls and increased following treatment. In contrast, connectivity for remitters was higher than controls at baseline and also following remission, suggesting a trait-like connectomic characteristic. Increased functional connectivity within and between large-scale intrinsic brain networks may characterize acute recovery with antidepressants in depression.",2020,"Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks.",['163 MDD and 62 healthy individuals underwent'],"['escitalopram, sertraline or venlafaxine-XR antidepressants', 'functional MRI']","['connectivity for remitters', 'intrinsic functional connectivity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",163.0,0.0349942,"Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks.","[{'ForeName': 'Mayuresh S', 'Initials': 'MS', 'LastName': 'Korgaonkar', 'Affiliation': 'The Brain Dynamics Centre, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia. m.korgaonkar@sydney.edu.au.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fornito', 'Affiliation': 'Brain and Mental Health Research Hub, Turner Institute for Brain and Mental Health & Monash Biomedical Imaging, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'The Brain Dynamics Centre, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia. leawilliams@stanford.edu.'}]",Molecular psychiatry,['10.1038/s41380-019-0574-2']
760,31010703,Leap Motion Controller-based training for upper extremity rehabilitation in children and adolescents with physical disabilities: A randomized controlled trial.,"STUDY DESIGN


Randomized controlled trial.
INTRODUCTION


Juvenile idiopathic arthritis (JIA), cerebral palsy (CP), and brachial plexus birth injury (BPBI) are the most common disorders that cause upper extremity impairments in children and adolescents. Leap Motion Controller-based training (LMCBT) is a novel therapeutic method for upper extremity rehabilitation.
PURPOSE OF THE STUDY


The aim of the present study was to investigate the potential efficacy of an 8-week LMCBT program set as an upper extremity rehabilitation program by comparing conventional rehabilitation program in children and adolescents with physical disabilities such as JIA, CP, and BPBI.
METHODS


A randomized control trial which included children and adolescents of different disabilities (JIA, CP, BPBI) were grouped according to their diagnosis. All patients were randomized into 2 groups namely LMCBT (group I) and conventional treatment (group II) for the treatment (3 days/8 weeks). Duruoz Hand Index and Jebson Taylor Hand Function Test were used as primary outcomes. Secondary outcomes included the nine-hole peg test, Childhood Health Assessment Questionnaire, and assessments of grip and pinch strength using a dynamometer.
RESULTS


One hundred three patients were included in the study, and 92 of them completed the treatment. After treatment, significant differences were found in Childhood Health Assessment Questionnaire, Duruoz Hand Index, Jebson Taylor Hand Function Test, nine-hole peg test, and grip and pinch strength scores in almost all groups (effect size [ES] = 0.10 to -0.77 for group I and 0.09 to -0.70 for group II in CP; ES = 0.31 to 2.65 for the group I and 0.12 to 1.66 for group II in JIA; and ES = 0 to -0.44 for group I and 0.08 to -0.62 for group II in BPBI) (P < .05). Comparisons between LMCBT and conventional treatment groups showed similar results in all parameters in all disease groups (P > .05).
CONCLUSIONS


This study has quantitatively shown that LMCBT should be used as an effective alternative treatment option in children and adolescents with physical disabilities.",2020,"Comparisons between LMCBT and conventional treatment groups showed similar results in all parameters in all disease groups (P > .05).
","['children and adolescents with physical disabilities such as JIA, CP, and BPBI', 'children and adolescents of different disabilities (JIA, CP, BPBI', 'One hundred three patients were included in the study, and 92 of them completed the treatment', 'children and adolescents with physical disabilities', 'children and adolescents']","['conventional treatment', 'Leap Motion Controller-based training (LMCBT', 'BPBI', 'LMCBT program', 'Leap Motion Controller-based training', 'LMCBT', 'conventional rehabilitation program']","['nine-hole peg test, Childhood Health Assessment Questionnaire, and assessments of grip and pinch strength using a dynamometer', 'Childhood Health Assessment Questionnaire, Duruoz Hand Index, Jebson Taylor Hand Function Test, nine-hole peg test, and grip and pinch strength scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0451335', 'cui_str': 'Nine hole peg test (assessment scale)'}, {'cui': 'C2732494', 'cui_str': 'Childhood health assessment questionnaire (assessment scale)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C1720876', 'cui_str': 'Pinch Strength'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0562230', 'cui_str': 'Hand functions (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",103.0,0.0321016,"Comparisons between LMCBT and conventional treatment groups showed similar results in all parameters in all disease groups (P > .05).
","[{'ForeName': 'Ela', 'Initials': 'E', 'LastName': 'Tarakci', 'Affiliation': 'Faculty of Health Sciences, Department of Neurological Physiotherapy and Rehabilitation, Istanbul University-Cerrahpasa, Bakirkoy, Istanbul, Turkey. Electronic address: fztela@hotmail.com.'}, {'ForeName': 'Nilay', 'Initials': 'N', 'LastName': 'Arman', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul University-Cerrahpasa, Bakirkoy, Istanbul, Turkey.'}, {'ForeName': 'Devrim', 'Initials': 'D', 'LastName': 'Tarakci', 'Affiliation': 'Faculty of Health Sciences, Department of Ergotherapy, Istanbul Medipol University, Bakirkoy, Istanbul, Turkey.'}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Kasapcopur', 'Affiliation': 'Medical Faculty of Cerrahpasa, Department of Pediatric Rheumatology, Istanbul University-Cerrahpasa, Bakirkoy, Istanbul, Turkey.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2019.03.012']
761,27704326,"Predictors of Participation in an eHealth, Family-Based Preventive Intervention for Hispanic Youth.","The Familias Unidas intervention is an efficacious family-based preventive intervention for reducing substance use and other health risks among Hispanic youth. A current randomized controlled trial (RCT) is examining this intervention's efficacy when delivered via the Internet (eHealth). eHealth interventions can overcome logistical barriers to participation, yet there is limited information about the feasibility of these interventions, especially among ethnic minorities. This paper examines participation and predictors of participation in the eHealth Familias Unidas intervention in a sample of 113 Hispanic families whose adolescent had behavioral problems. Analyses examined multidimensional ways of characterizing participation, including the following: (1) total intervention participation, (2) initial engagement (participating in at least one of the first three intervention sessions), (3) completing the pre-recorded, eHealth parent group sessions, and (4) participating in the live, facilitator-led, eHealth family sessions. Participation in this eHealth intervention was comparable to, and in most cases higher than, previous, face-to-face Familias Unidas interventions. High levels of baseline family stress were associated with lower initial engagement and lower family session participation. Greater parental Hispanicism was associated with more participation in eHealth parent group sessions and across the total intervention. Higher levels of baseline effective parenting, in other words less intervention need, were significantly associated with lower levels of total intervention participation and lower levels of family session participation. Implications for preventive interventions delivered via Internet are discussed.",2018,The Familias Unidas intervention is an efficacious family-based preventive intervention for reducing substance use and other health risks among Hispanic youth.,"['Hispanic youth', '113 Hispanic families whose adolescent had behavioral problems', 'Hispanic Youth']","['eHealth parent group sessions, and (4) participating in the live, facilitator-led, eHealth family sessions']",['total intervention participation and lower levels of family session participation'],"[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",113.0,0.016083,The Familias Unidas intervention is an efficacious family-based preventive intervention for reducing substance use and other health risks among Hispanic youth.,"[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Perrino', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street (R-669), Miami, FL, 33136, USA. tperrino@miami.edu.'}, {'ForeName': 'Yannine', 'Initials': 'Y', 'LastName': 'Estrada', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street (R-669), Miami, FL, 33136, USA.'}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'St George', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street (R-669), Miami, FL, 33136, USA.'}, {'ForeName': 'Hilda', 'Initials': 'H', 'LastName': 'Pantin', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street (R-669), Miami, FL, 33136, USA.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Cano', 'Affiliation': 'Department of Epidemiology, Robert Stempel College of Public Health & Social Work, Florida International University, Miami, FL, USA.'}, {'ForeName': 'Tae Kyoung', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street (R-669), Miami, FL, 33136, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Prado', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, 1120 NW 14th Street (R-669), Miami, FL, 33136, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-016-0711-y']
762,31006080,Tailoring Cognitive Behavioral Therapy for Depression and Anxiety Symptoms in Mexican Terminal Cancer Patients: A Multiple Baseline Study.,"The purpose of this study was to assess the effect of tailored cognitive behavioral therapy (CBT) on depression and anxiety symptoms present in Mexican terminal cancer patients. A non-concurrent multiple baseline design was used across individuals. Nine patients participated in the study, each receiving four to six therapy sessions. The effect size of the intervention range (NAP and Tau indexes) in the nine patients indicates that CBT intervention resulted in weak to moderate impact for anxiety and depression symptoms in this population. The overall standardized mean difference is also moderate, with a reduction of 0.54 and 0.76 standard deviations in depression and anxiety symptoms, respectively. This study provides initial evidence to support a positive effect from CBT on patients with terminal cancer and with mood disorders when facing their impending death.",2020,"The overall standardized mean difference is also moderate, with a reduction of 0.54 and 0.76 standard deviations in depression and anxiety symptoms, respectively.","['patients with terminal cancer and with mood disorders', 'Mexican terminal cancer patients', 'Nine patients participated in the study, each receiving four to six therapy sessions', 'Mexican Terminal Cancer Patients']","['CBT intervention', 'Tailoring Cognitive Behavioral Therapy', 'tailored cognitive behavioral therapy (CBT', 'CBT']","['anxiety and depression symptoms', 'depression and anxiety symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0525045', 'cui_str': 'Affective Disorders'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",9.0,0.0398485,"The overall standardized mean difference is also moderate, with a reduction of 0.54 and 0.76 standard deviations in depression and anxiety symptoms, respectively.","[{'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Landa-Ramírez', 'Affiliation': 'Health Psychology and Behavioral Medicine Program/School of Psychology, National Autonomous University of Mexico (UNAM), Mexico City, Mexico. edgar_landa_ramirez@yahoo.com.mx.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital, Cancer Center & Harvard Medical School, Boston, USA.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Sánchez-Román', 'Affiliation': 'Department of Neurology and Psychiatry, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Rumen', 'Initials': 'R', 'LastName': 'Manolov', 'Affiliation': 'Department of Social Psychology and Quantitative Psychology, Faculty of Psychology, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Ma Magdalena', 'Initials': 'MM', 'LastName': 'Salado-Avila', 'Affiliation': 'Palliative Care & Pain Department, Hospital General ""Dr. Manuel Gea González"", Mexico City, Mexico.'}, {'ForeName': 'Luz Adriana', 'Initials': 'LA', 'LastName': 'Templos-Esteban', 'Affiliation': 'Palliative Care & Pain Department, Hospital General ""Dr. Manuel Gea González"", Mexico City, Mexico.'}, {'ForeName': 'Angélica', 'Initials': 'A', 'LastName': 'Riveros-Rosas', 'Affiliation': 'School of Business Administration, National Autonomous University of Mexico (UNAM), Mexico City, Mexico.'}]",Journal of clinical psychology in medical settings,['10.1007/s10880-019-09620-8']
763,30947585,Blinatumomab versus chemotherapy in first salvage or in later salvage for B-cell precursor acute lymphoblastic leukemia.,"Outcomes for adults with relapsed/refractory acute lymphoblastic leukemia (ALL) are poor with chemotherapy, particularly in later salvage. The TOWER study examined survival, remission, bridge to allogeneic hematopoietic stem cell transplantation (HSCT), and safety with blinatumomab versus chemotherapy. This report examined outcomes separately for study treatment as first or later salvage. Adults with Philadelphia chromosome-negative B-cell precursor ALL relapsed/refractory to chemotherapy were randomly assigned 2:1 to receive blinatumomab by continuous infusion for 4 weeks in 6-week cycles, or standard salvage chemotherapy. Overall survival for blinatumomab versus chemotherapy was higher both in first salvage and in later salvage. Safety was similar between patients in first salvage and those in later salvage. Blinatumomab as later salvage was associated with higher complete remission rates and served as a bridge to allogeneic HSCT, supporting the use of blinatumomab in both settings. This study is registered at www.clinicaltrials.gov as #NCT02013167.",2019,"Blinatumomab as later salvage was associated with higher complete remission rates and served as a bridge to allogeneic HSCT, supporting the use of blinatumomab in both settings.","['Adults with Philadelphia chromosome-negative B-cell precursor ALL relapsed/refractory to chemotherapy', 'adults with relapsed/refractory acute lymphoblastic leukemia (ALL', 'B-cell precursor acute lymphoblastic leukemia']","['standard salvage chemotherapy', 'blinatumomab', 'Blinatumomab versus chemotherapy', 'allogeneic hematopoietic stem cell transplantation (HSCT', 'blinatumomab versus chemotherapy']","['complete remission rates', 'Safety', 'Overall survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3888511', 'cui_str': 'Philadelphia chromosome negative'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3853839', 'cui_str': 'blinatumomab'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0302086,"Blinatumomab as later salvage was associated with higher complete remission rates and served as a bridge to allogeneic HSCT, supporting the use of blinatumomab in both settings.","[{'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Dombret', 'Affiliation': 'Department of Hematology, Hôpital Saint-Louis (Assistance Publique - Hôpitaux de Paris) and University Paris Diderot , Paris , France.'}, {'ForeName': 'Max S', 'Initials': 'MS', 'LastName': 'Topp', 'Affiliation': 'Klinik und Poliklinik II, Universitätsklinikum Würzburg , Würzburg , Germany.'}, {'ForeName': 'Andre C', 'Initials': 'AC', 'LastName': 'Schuh', 'Affiliation': 'Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network , Toronto , Canada.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Wei', 'Affiliation': 'Department of Haematology, Alfred Hospital and Monash University , Melbourne , Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Durrant', 'Affiliation': 'Bone Marrow Transplant Unit, Royal Brisbane Hospital , Herston , Australia.'}, {'ForeName': 'Christopher Larry', 'Initials': 'CL', 'LastName': 'Bacon', 'Affiliation': ""Haematology Department, St. James's Hospital , Dublin , Ireland.""}, {'ForeName': 'Qui', 'Initials': 'Q', 'LastName': 'Tran', 'Affiliation': 'Amgen Inc , Thousand Oaks , CA , USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Zimmerman', 'Affiliation': 'Amgen Inc , Thousand Oaks , CA , USA.'}, {'ForeName': 'Hagop', 'Initials': 'H', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, University of Texas M.D. Anderson Cancer Center , Houston , TX , USA.'}]",Leukemia & lymphoma,['10.1080/10428194.2019.1576872']
764,30939096,"Seven-Year Follow-Up Analysis of Adjuvant Paclitaxel and Trastuzumab Trial for Node-Negative, Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer.","PURPOSE


The Adjuvant Paclitaxel and Trastuzumab trial was designed to address treatment of patients with small human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The primary analysis of the Adjuvant Paclitaxel and Trastuzumab trial demonstrated a 3-year disease-free survival (DFS) of 98.7%. In this planned secondary analysis, we report longer-term outcomes and exploratory results to characterize the biology of small HER2-positive tumors and genetic factors that may predispose to paclitaxel-induced peripheral neuropathy (TIPN).
PATIENTS AND METHODS


In this phase II study, patients with HER2-positive breast cancer with tumors 3 cm or smaller and negative nodes received paclitaxel (80 mg/m 2 ) with trastuzumab for 12 weeks, followed by trastuzumab for 9 months. The primary end point was DFS. Recurrence-free interval (RFI), breast cancer-specific survival, and overall survival (OS) were also analyzed. In an exploratory analysis, intrinsic subtyping by PAM50 (Prosigna) and calculation of the risk of recurrence score were performed on the nCounter analysis system on archival tissue. Genotyping was performed to investigate TIPN.
RESULTS


A total of 410 patients were enrolled from October 2007 to September 2010. After a median follow-up of 6.5 years, there were 23 DFS events. The 7-year DFS was 93% (95% CI, 90.4 to 96.2) with four (1.0%) distant recurrences, 7-year OS was 95% (95% CI, 92.4 to 97.7), and 7-year RFI was 97.5% (95% CI, 95.9 to 99.1). PAM50 analyses (n = 278) showed that most tumors were HER2-enriched (66%), followed by luminal B (14%), luminal A (13%), and basal-like (8%). Genotyping (n = 230) identified one single-nucleotide polymorphism,  rs3012437 , associated with an increased risk of TIPN in patients with grade 2 or greater TIPN (10.4%).
CONCLUSION


With longer follow-up, adjuvant paclitaxel and trastuzumab is associated with excellent long-term outcomes. Distribution of PAM50 intrinsic subtypes in small HER2-positive tumors is similar to that previously reported for larger tumors.",2019,"Genotyping (n = 230) identified one single-nucleotide polymorphism, rs3012437, associated with an increased risk of TIPN in patients with grade 2 or greater TIPN (10.4%).
","['patients with HER2-positive breast cancer with tumors 3 cm or smaller and negative nodes received', '410 patients were enrolled from October 2007 to September 2010', 'patients with grade 2 or greater TIPN (10.4', 'patients with small human epidermal growth factor receptor 2 (HER2)-positive breast cancer']","['adjuvant paclitaxel and trastuzumab', 'trastuzumab', 'paclitaxel']","['distant recurrences, 7-year OS', 'Recurrence-free interval (RFI), breast cancer-specific survival, and overall survival (OS', '7-year RFI', '3-year disease-free survival (DFS', 'DFS', '7-year DFS', 'risk of TIPN']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",410.0,0.0620248,"Genotyping (n = 230) identified one single-nucleotide polymorphism, rs3012437, associated with an increased risk of TIPN in patients with grade 2 or greater TIPN (10.4%).
","[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'Tolaney', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pernas', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Barry', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Dillon', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Ritterhouse', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Bryan P', 'Initials': 'BP', 'LastName': 'Schneider', 'Affiliation': '5Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': '5Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Kit', 'Initials': 'K', 'LastName': 'Fuhrman', 'Affiliation': 'NanoString Technologies, Seattle, WA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Baltay', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Chau T', 'Initials': 'CT', 'LastName': 'Dang', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Yardley', 'Affiliation': '9Sarah Cannon Cancer Center, Nashville, TN.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Moy', 'Affiliation': 'Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'P Kelly', 'Initials': 'PK', 'LastName': 'Marcom', 'Affiliation': 'Duke Cancer Institute, Durham, NC.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'Loyola University Chicago Stritch School of Medicine, Maywood, IL.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Mathew J', 'Initials': 'MJ', 'LastName': 'Ellis', 'Affiliation': 'Baylor Clinic Lester and Sue Smith Breast Center, Houston, TX.'}, {'ForeName': 'Iuliana', 'Initials': 'I', 'LastName': 'Shapira', 'Affiliation': 'Hofstra North Shore-LIJ School of Medicine, New Hyde Park, NY.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Overmoyer', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Clifford A', 'Initials': 'CA', 'LastName': 'Hudis', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Ian E', 'Initials': 'IE', 'LastName': 'Krop', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Harold J', 'Initials': 'HJ', 'LastName': 'Burstein', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': '1Dana-Farber Cancer Institute, Boston, MA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00066']
765,30990245,Two-year safety evaluation of a biodegradable polymer sirolimus-eluting stent with increased drug elution and polymer absorption kinetics in complex patient and lesion cohort.,"OBJECTIVES


The aim of the present report was to compare 2-year safety outcomes of two biodegradable polymer (BP) sirolimus-eluting stents (SESs) with different drug eluting and polymer absorption kinetics in a subgroup of complex patients and lesions.
BACKGROUND


The previously published PANDA III study showed the BuMA BP SES, with faster drug elution and polymer absorption, was non-inferior to the Excel SES in target lesion failure (TLF).
METHODS


In PANDA III trial, patients who fulfilled one or more of the following criteria were included: Small vessel disease (reference vessel diameter ≤ 2.5 mm); long lesion (lesion length ≥ 20 mm); chronic total occlusion lesion; and diabetic patients.
RESULTS


Among 2,348 patients randomly assigned to treatment with BuMA (n = 1,174) or Excel SES (n = 1,174) in the PANDA III study, 858 in the BuMA group and 855 in the Excel group satisfied the inclusion criteria. At 2-year follow-up, the incidence of definite/probable stent thrombosis (ST) was significantly lower with BuMA SES as compared with Excel SES (0.7% vs. 1.9%, p = 0.03). This difference was mainly caused by decreased subacute stent thrombosis rate (0% vs. 0.6%, p = 0.03). In patients who did not fulfill the complex patient and lesion criteria, there were no between-group difference in ST (0.7% vs. 0%, p = 0.50). Myocardial infarction and TLF rates were similar (5.7% vs. 6.0%, p = 0.79 and 8.8% vs. 7.5%, p = 0.34, respectively), whereas patient-oriented composite endpoint was higher with BuMA SES mainly due to high risk of revascularization (15.6% vs. 11.4%, p = 0.01; 8.4% vs. 4.6%, p < 0.01).
CONCLUSIONS


Two-year subgroup analysis of the all-comer PANDA III trial revealed the increased safety benefit of the BuMA SES is more prominently seen in complex patient and lesion population.
CLINICAL TRIAL


ClinicalTrial.gov, Identifier-NCT02017275.",2020,"Myocardial infarction and TLF rates were similar (5.7% vs. 6.0%, p = 0.79 and 8.8% vs. 7.5%, p = 0.34, respectively), whereas patient-oriented composite endpoint was higher with BuMA SES mainly due to high risk of revascularization (15.6% vs. 11.4%, p = 0.01; 8.4% vs. 4.6%, p < 0.01).
","['2,348 patients randomly assigned to treatment with', 'patients who fulfilled one or more of the following criteria were included: Small vessel disease (reference vessel diameter\u2009≤\u20092.5 mm); long lesion (lesion length\u2009≥\u200920\u2009mm); chronic total occlusion lesion; and diabetic patients', 'a subgroup of complex patients and lesions', 'complex patient and lesion cohort']","['biodegradable polymer (BP) sirolimus-eluting stents (SESs', 'BuMA', 'biodegradable polymer sirolimus-eluting stent', 'Excel SES']","['2-year safety outcomes', 'drug elution and polymer absorption kinetics', 'subacute stent thrombosis rate', 'ST', 'Myocardial infarction and TLF rates', 'incidence of definite/probable stent thrombosis (ST']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]","[{'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C2740529', 'cui_str': 'Excel'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}]",2348.0,0.144185,"Myocardial infarction and TLF rates were similar (5.7% vs. 6.0%, p = 0.79 and 8.8% vs. 7.5%, p = 0.34, respectively), whereas patient-oriented composite endpoint was higher with BuMA SES mainly due to high risk of revascularization (15.6% vs. 11.4%, p = 0.01; 8.4% vs. 4.6%, p < 0.01).
","[{'ForeName': 'Sida', 'Initials': 'S', 'LastName': 'Jia', 'Affiliation': 'Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Changdong', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': 'Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jinqing', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Xuebin', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiology, Chinese PLA 252 Hospital, Baoding, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Department of Cardiology, Kaifeng Central Hospital, Kaifeng, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Yunnan St. John's Hospital, Kunming, China.""}, {'ForeName': 'Zhanquan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Liaoning Provincial People's Hospital, Shenyang, China.""}, {'ForeName': 'Shaoping', 'Initials': 'S', 'LastName': 'Nie', 'Affiliation': 'Department of Cardiology, Affiliated Anzhen Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Hou', 'Affiliation': 'Department of Statistical Analysis, China Cardiovascular Research Foundation Inc, Beijing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Statistical Analysis, China Cardiovascular Research Foundation Inc, Beijing, China.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Brouwer', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Suryapranata', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Runlin', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28288']
766,29532784,A pragmatic randomised controlled trial and economic evaluation of family therapy versus treatment as usual for young people seen after second or subsequent episodes of self-harm: the Self-Harm Intervention - Family Therapy (SHIFT) trial.,"BACKGROUND


Self-harm in adolescents is common and repetition rates high. There is limited evidence of the effectiveness of interventions to reduce self-harm.
OBJECTIVES


To assess the clinical effectiveness and cost-effectiveness of family therapy (FT) compared with treatment as usual (TAU).
DESIGN


A pragmatic, multicentre, individually randomised controlled trial of FT compared with TAU. Participants and therapists were aware of treatment allocation; researchers were blind to allocation.
SETTING


Child and Adolescent Mental Health Services (CAMHS) across three English regions.
PARTICIPANTS


Young people aged 11-17 years who had self-harmed at least twice presenting to CAMHS following self-harm.
INTERVENTIONS


Eight hundred and thirty-two participants were randomised to manualised FT delivered by trained and supervised family therapists ( n  = 415) or to usual care offered by local CAMHS following self-harm ( n  = 417).
MAIN OUTCOME MEASURES


Rates of repetition of self-harm leading to hospital attendance 18 months after randomisation.
RESULTS


Out of 832 young people, 212 (26.6%) experienced a primary outcome event: 118 out of 415 (28.4%) randomised to FT and 103 out of 417 (24.7%) randomised to TAU. There was no evidence of a statistically significant difference in repetition rates between groups (the hazard ratio for FT compared with TAU was 1.14, 95% confidence interval 0.87 to 1.49;  p  = 0.3349). FT was not found to be cost-effective when compared with TAU in the base case and most sensitivity analyses. FT was dominated (less effective and more expensive) in the complete case. However, when young people's and caregivers' quality-adjusted life-year gains were combined, FT incurred higher costs and resulted in better health outcomes than TAU within the National Institute for Health and Care Excellence cost-effectiveness range. Significant interactions with treatment, indicating moderation, were detected for the unemotional subscale on the young person-reported Inventory of Callous-Unemotional Traits ( p  = 0.0104) and the affective involvement subscale on the caregiver-reported McMaster Family Assessment Device ( p  = 0.0338). Caregivers and young people in the FT arm reported a range of significantly better outcomes on the Strengths and Difficulties Questionnaire. Self-reported suicidal ideation was significantly lower in the FT arm at 12 months but the same in both groups at 18 months. No significant unexpected adverse events or side effects were reported, with similar rates of expected adverse events across trial arms.
CONCLUSIONS


For adolescents referred to CAMHS after self-harm, who have self-harmed at least once before, FT confers no benefits over TAU in reducing self-harm repetition rates. There is some evidence to support the effectiveness of FT in reducing self-harm when caregivers reported poor family functioning. When the young person themselves reported difficulty expressing emotion, FT did not seem as effective as TAU. There was no evidence that FT is cost-effective when only the health benefits to participants were considered but there was a suggestion that FT may be cost-effective if health benefits to caregivers are taken into account. FT had a significant, positive impact on general emotional and behavioural problems at 12 and 18 months.
LIMITATIONS


There was significant loss to follow-up for secondary outcomes and health economic analyses; the primary outcome misses those who do not attend hospital following self-harm; and the numbers receiving formal FT in the TAU arm were higher than expected.
FUTURE WORK


Evaluation of interventions targeted at subgroups of those who self-harm, longer-term follow-up and methods for evaluating health benefits for family groups rather than for individuals.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN59793150.
FUNDING


This project was funded by the NIHR Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 22, No. 12. See the NIHR Journals Library website for further project information.",2018,"There was no evidence of a statistically significant difference in repetition rates between groups (the hazard ratio for FT compared with TAU was 1.14, 95% confidence interval 0.87 to 1.49;  p  = 0.3349).","['832 young people, 212 (26.6%) experienced a primary outcome event: 118 out of 415 (28.4%) randomised to', 'young people seen after second or subsequent episodes of self-harm', 'Young people aged 11-17 years who had self-harmed at least twice presenting to CAMHS following self-harm', 'Eight hundred and thirty-two participants', 'Child and Adolescent Mental Health Services']","['TAU', 'FT', 'manualised FT delivered by trained and supervised family therapists ( n \u2009=\u2009415) or to usual care offered by local CAMHS following self-harm ( n \u2009=\u2009417', 'family therapy (FT']","['health outcomes', 'Self-reported suicidal ideation', 'unemotional subscale on the young person-reported Inventory of Callous-Unemotional Traits', 'general emotional and behavioural problems', 'adverse events or side effects', 'clinical effectiveness and cost-effectiveness', 'Strengths and Difficulties Questionnaire', 'cost-effective', 'repetition rates', 'Rates of repetition of self-harm leading to hospital attendance 18 months after randomisation']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C4517772', 'cui_str': 'Four hundred and fifteen'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4517889', 'cui_str': '830 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025355', 'cui_str': 'Mental Hygiene Services'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4517772', 'cui_str': 'Four hundred and fifteen'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}, {'cui': 'C0015618', 'cui_str': 'Family Therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire (assessment scale)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0085271', 'cui_str': 'Self-Injury'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",832.0,0.164895,"There was no evidence of a statistically significant difference in repetition rates between groups (the hazard ratio for FT compared with TAU was 1.14, 95% confidence interval 0.87 to 1.49;  p  = 0.3349).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cottrell', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Wright-Hughes', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Collinson', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Boston', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Eisler', 'Affiliation': ""Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fortune', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Elizabeth H', 'Initials': 'EH', 'LastName': 'Graham', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, UK.'}, {'ForeName': 'Allan O', 'Initials': 'AO', 'LastName': 'House', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kerfoot', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, University of Manchester, Manchester, UK.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Owens', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Eirini-Christina', 'Initials': 'EC', 'LastName': 'Saloniki', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Mima', 'Initials': 'M', 'LastName': 'Simic', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Tubeuf', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Farrin', 'Affiliation': 'Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta22120']
767,30961424,Effects of a short video feedback intervention on enhancing maternal sensitivity and infant development in low-income families.,"This study evaluated the effects of a short video feedback intervention aimed at enhancing maternal sensitivity and the development of infants from low-income families in a randomized controlled trial. Forty-four mother-infant dyads living in low-income communities from Salvador, Brazil were randomly assigned between intervention and control groups. Maternal sensitivity was assessed during free-play and infant development was evaluated with a standardized scale. Intervention took place in eight home visits between the infant's third and tenth month. Results showed mothers in the intervention group interpreted the meaning of their infants' behavior more often (r = 0.33), asked babies more questions (r = 0.39), and were less intrusive (r = 0.47) when compared to controls on posttest. The absence of significant intervention effects on infant development suggests the need for additional intervention strategies and a greater time lag between maternal sensitivity and infant development assessments to detect possible delayed effects.",2020,"Results showed mothers in the intervention group interpreted the meaning of their infants' behavior more often (r = 0.33), asked babies more questions (r = 0.39), and were less intrusive (r = 0.47) when compared to controls on posttest.","['infants from low-income\xa0families', 'low-income families', 'Forty-four\xa0mother-infant dyads living in low-income\xa0communities from Salvador, Brazil']",['short video feedback intervention'],"['maternal sensitivity and infant development', 'Maternal sensitivity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205714', 'cui_str': 'Infant Development'}]",44.0,0.0368303,"Results showed mothers in the intervention group interpreted the meaning of their infants' behavior more often (r = 0.33), asked babies more questions (r = 0.39), and were less intrusive (r = 0.47) when compared to controls on posttest.","[{'ForeName': 'Patrícia', 'Initials': 'P', 'LastName': 'Alvarenga', 'Affiliation': 'Institute of Psychology, Federal University of Bahia , Salvador, Brazil.'}, {'ForeName': 'Maria Ángeles', 'Initials': 'MÁ', 'LastName': 'Cerezo', 'Affiliation': 'Department of Basic Psychology, University of Valencia , Valencia, Spain.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Wiese', 'Affiliation': 'University College Roosevelt, Utrecht University , Middelburg, The Netherlands.'}, {'ForeName': 'Cesar Augusto', 'Initials': 'CA', 'LastName': 'Piccinini', 'Affiliation': 'Institute of Psychology, Federal University of Rio Grande do Sul , Porto Alegre, Brazil.'}]",Attachment & human development,['10.1080/14616734.2019.1602660']
768,30763948,Impact of Baseline Features and Risk Factor Control on Cognitive Function in the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial.,"BACKGROUND


Cerebrovascular disease is an important cause of cognitive impairment. The aim of this study is to report the relationship between cognitive function and risk factors at baseline and during follow-up in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial.
METHODS


Subjects in the SAMMPRIS trial were included in this study. In order to have an assessment of cognitive function independent of stroke, patients with a stroke as a qualifying event whose deficits included aphasia or neglect were excluded from these analyses as were those with a cerebrovascular event during follow-up. The Montreal Cognitive Assessment (MoCA) score was used to assess cognitive impairment at baseline, 4 months, 12 months and closeout. Cognitive impairment was defined as MoCA < 26. A multivariate analysis was performed to determine what risk factors were independent predictors of cognitive function at baseline, 12 months and closeout. Among patients randomized to aggressive medical management only, the percentage of patients with cognitive impairment was compared between patients in versus out of target for each risk factor at 12 months and closeout.
RESULTS


Of the 451 patients in SAMMPRIS, 371 patients met the inclusion criteria. MoCA < 26 was present in 55% at baseline. Older age and physical inactivity were associated with cognitive impairment at baseline. Older age, non-white race, lower baseline body mass index, and baseline cognitive impairment were associated with cognitive impairment at 12 months. In the aggressive medical management group, at 12 months, physical inactivity during follow-up was the strongest risk factor associated with cognitive impairment.
CONCLUSION


Cognitive impairment is common in patients with severe symptomatic intracranial atherosclerosis. Physical inactivity at baseline and during follow-up is a strong predictor of cognitive impairment.",2019,"In the aggressive medical management group, at 12 months, physical inactivity during follow-up was the strongest risk factor associated with cognitive impairment.
","['451 patients in SAMMPRIS', 'Subjects in the SAMMPRIS trial were included in this study', 'patients with a stroke as a qualifying event whose deficits included aphasia or neglect were excluded from these analyses as were those with a cerebrovascular event during follow-up', 'patients with severe symptomatic intracranial atherosclerosis', '371 patients met the inclusion criteria']","['MoCA', 'Baseline Features and Risk Factor Control']","['Cognitive impairment', 'Montreal Cognitive Assessment (MoCA) score', 'physical inactivity', 'cognitive impairment', 'Older age and physical inactivity', 'Physical inactivity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0003537', 'cui_str': 'Anepia'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0751007', 'cui_str': 'Intracranial Atherosclerosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}]",451.0,0.0502547,"In the aggressive medical management group, at 12 months, physical inactivity during follow-up was the strongest risk factor associated with cognitive impairment.
","[{'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Al Kasab', 'Affiliation': 'Department of Neurology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA, sami-alkasab@uiowa.edu.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Smock', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Cotsonis', 'Affiliation': 'Department of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bachman', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Lynn', 'Affiliation': 'Washington University, St. Louis, Michigan, USA.'}, {'ForeName': 'Azhar', 'Initials': 'A', 'LastName': 'Nizam', 'Affiliation': 'Department of Neurology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.'}, {'ForeName': 'Colin P', 'Initials': 'CP', 'LastName': 'Derdeyn', 'Affiliation': 'Department of Neurology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fiorella', 'Affiliation': 'Department of Neurosurgery, State University of New York at Stony Brook, Stony Brook, New York, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Janis', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, Bethesda, Maryland, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Lane', 'Affiliation': 'Department of Neurology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Montgomery', 'Affiliation': 'Department of Public Health, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'Marc I', 'Initials': 'MI', 'LastName': 'Chimowitz', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Cerebrovascular diseases (Basel, Switzerland)",['10.1159/000497245']
769,30934166,"Pharmacokinetic Properties of Single and Multiple Doses of Ertugliflozin, a Selective Inhibitor of SGLT2, in Healthy Chinese Subjects.","Ertugliflozin, a sodium-glucose cotransporter 2 inhibitor for the treatment of type 2 diabetes mellitus, prevents renal glucose reabsorption resulting in urinary glucose excretion. This open-label, parallel cohort, randomized study conducted in healthy Chinese adults residing in China assessed the pharmacokinetics, tolerability, and safety of 5 mg and 15 mg of ertugliflozin following single (fasted condition) and multiple-dose (fed condition) administration. Sixteen subjects were randomized and completed the study. Ertugliflozin absorption was rapid, with maximum plasma concentrations observed 1 hour after dosing under fasted conditions and 2 to 4 hours after dosing under fed conditions. Following single- and multiple-dose administration, ertugliflozin exhibited dose-proportional exposures with an apparent mean terminal half-life of approximately 9.5 to 11.9 hours. Steady state was reached after 4 once-daily doses. The accumulation ratio based on the area under the plasma concentration-time curve after multiple-dose administration was approximately 1.3 and 1.2 for ertugliflozin 5 mg and 15 mg, respectively. Ertugliflozin was generally well tolerated following administration of single and multiple oral doses of 5 mg and 15 mg in healthy Chinese subjects. Pharmacokinetic comparison with non-Asian subjects indicated that there are no clinically meaningful racial differences and no dose modification of ertugliflozin is required based on race or body weight.",2020,Pharmacokinetic comparison with non-Asian subjects indicated that there are no clinically meaningful racial differences and no dose modification of ertugliflozin is required based on race or body weight.,"['type 2 diabetes mellitus', 'healthy Chinese adults residing in China assessed the', 'Sixteen subjects', 'Healthy Chinese Subjects', 'healthy Chinese subjects']","['ertugliflozin', 'Ertugliflozin, a sodium-glucose cotransporter 2 inhibitor', 'Ertugliflozin']","['pharmacokinetics, tolerability, and safety', 'Ertugliflozin absorption', 'accumulation ratio based on the area under the plasma concentration-time curve', 'Steady state', 'maximum plasma concentrations']","[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}]",16.0,0.0260303,Pharmacokinetic comparison with non-Asian subjects indicated that there are no clinically meaningful racial differences and no dose modification of ertugliflozin is required based on race or body weight.,"[{'ForeName': 'Yinhua', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Pfizer R&D Japan, Tokyo, Japan.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Mu', 'Affiliation': 'Pfizer (China) R&D Center, Beijing, China.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Zeyuan', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""307 Hospital of People's Liberation Army, Beijing, China.""}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Matschke', 'Affiliation': 'Pfizer Inc., Collegeville, PA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Krishna', 'Affiliation': 'Merck & Co, Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Sahasrabudhe', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.686']
770,31706658,Comparison of high-flow nasal cannula oxygen therapy and conventional reserve-bag oxygen therapy in carbon monoxide intoxication: A pilot study.,"BACKGROUND


High-flow nasal cannula oxygen (HFNC) creates a positive pressure effect through high-flow rates compared to conventional oxygen therapy. The purpose of this human pilot study is to compare the effects of HFNC and conventional oxygen therapy on the rate of carbon monoxide (CO) clearance from the blood in patients with mild to moderate CO poisoning.
METHODS


CO-poisoned Patients randomly received 100% oxygen from a rebreathing reserve mask (NBO 2 , flow of 15 L/min) or HFNC (flow of 60 L/min). The fraction of COHb value (fCOHb) was measured in 30-min intervals until it fell to under 10%. We determined the Half-life time of fCOHb (fCOHb t 1/2 ).
RESULTS


A total of 22 patients had fCOHb levels ≥ 10% at the time of ED arrival, with 9 of them having fCOHb level ranging between 25% and 50%. There was no significant difference in the fCOHbt 1/2  between the HFNC group and NBO 2  group. However, the mean fCOHbt 1/2  in the HFNC group (48.5 ± 12.4 min) has a smaller standard deviation than that in the NBO 2  group (99.3 ± 93.38 min). There were significant between-group differences in the mean COHbt 1/2  among the patients with fCOHb levels less than 25% (HFNC 43.6 ± 10.6 vs. NBO 2  134.2 ± 111.3).
CONCLUSIONS


In this pilot randomized controlled trial study, HFNC therapy did not reduce fCOHbt 1/2  compared to NBO 2  therapy but could be beneficial in maintaining a constant fCOHbt 1/2  as well as in reducing fCOHbt 1/2  in mild CO poisoning patients compared to conventional NBO 2  therapy. However, further studies with a larger number of patients are needed to establish HFNC therapy as an alternative therapy for CO poisoning patients.",2020,There was no significant difference in the fCOHbt 1/2  between the HFNC group and NBO 2  group.,"['CO poisoning patients', 'patients with mild to moderate CO poisoning', 'mild CO poisoning patients', 'carbon monoxide intoxication', 'CO-poisoned Patients randomly received']","['HFNC therapy', 'HFNC', 'high-flow nasal cannula oxygen therapy and conventional reserve-bag oxygen therapy', 'HFNC and conventional oxygen therapy', '100% oxygen from a rebreathing reserve mask (NBO 2 , flow of 15\u202fL/min) or HFNC', 'High-flow nasal cannula oxygen (HFNC']","['fraction of COHb value (fCOHb', 'rate of carbon monoxide (CO) clearance']","[{'cui': 'C0032343', 'cui_str': 'Poisoning'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}, {'cui': 'C0032344', 'cui_str': 'poisoning'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}]","[{'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",,0.0854453,There was no significant difference in the fCOHbt 1/2  between the HFNC group and NBO 2  group.,"[{'ForeName': 'Young-Min', 'Initials': 'YM', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Chungbuk National University Hospital, 776, Sunhwan-ro, Seowon-gu, Cheongju, Republic of Korea.'}, {'ForeName': 'Hyun-Jo', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Emergency Medicine, Chungbuk National University Hospital, 776, Sunhwan-ro, Seowon-gu, Cheongju, Republic of Korea.'}, {'ForeName': 'Dong-Won', 'Initials': 'DW', 'LastName': 'Choi', 'Affiliation': 'Department of Emergency Medicine, Chungbuk National University Hospital, 776, Sunhwan-ro, Seowon-gu, Cheongju, Republic of Korea.'}, {'ForeName': 'Ji-Min', 'Initials': 'JM', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Chungbuk National University Hospital, 776, Sunhwan-ro, Seowon-gu, Cheongju, Republic of Korea.'}, {'ForeName': 'Suk-Woo', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medicine, Chungbuk National University Hospital, 776, Sunhwan-ro, Seowon-gu, Cheongju, Republic of Korea; Department of Emergency Medicine, College of Medicine, Chungbuk National University, 1, Chungdae-ro, Seowon-gu, Cheongju, Republic of Korea.'}, {'ForeName': 'Seong-Hae', 'Initials': 'SH', 'LastName': 'Jeong', 'Affiliation': 'Department of Neurology, Chungnam National University Hospital, 282, Munhwa-ro, Jung-gu, Daejeon, Republic of Korea; Department of Neurology, Chungnam National University, School of Medicine, 282, Munhwa-ro, Jung-gu, Daejeon, Republic of Korea.'}, {'ForeName': 'Hoon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Emergency Medicine, Chungbuk National University Hospital, 776, Sunhwan-ro, Seowon-gu, Cheongju, Republic of Korea; Department of Emergency Medicine, College of Medicine, Chungbuk National University, 1, Chungdae-ro, Seowon-gu, Cheongju, Republic of Korea. Electronic address: nichekh2000@chungbuk.ac.kr.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.158451']
771,30873912,Angioplasty in asymptomatic carotid artery stenosis vs. endarterectomy compared to best medical treatment: One-year interim results of SPACE-2.,"BACKGROUND


Treatment of individuals with asymptomatic carotid artery stenosis is still handled controversially. Recommendations for treatment of asymptomatic carotid stenosis with carotid endarterectomy (CEA) are based on trials having recruited patients more than 15 years ago. Registry data indicate that advances in best medical treatment (BMT) may lead to a markedly decreasing risk of stroke in asymptomatic carotid stenosis. The aim of the SPACE-2 trial (ISRCTN78592017) was to compare the stroke preventive effects of BMT alone with that of BMT in combination with CEA or carotid artery stenting (CAS), respectively, in patients with asymptomatic carotid artery stenosis of ≥70% European Carotid Surgery Trial (ECST) criteria.
METHODS


SPACE-2 is a randomized, controlled, multicenter, open study. A major secondary endpoint was the cumulative rate of any stroke (ischemic or hemorrhagic) or death from any cause within 30 days plus an ipsilateral ischemic stroke within one year of follow-up. Safety was assessed as the rate of any stroke and death from any cause within 30 days after CEA or CAS. Protocol changes had to be implemented. The results on the one-year period after treatment are reported.
FINDINGS


It was planned to enroll 3550 patients. Due to low recruitment, the enrollment of patients was stopped prematurely after randomization of 513 patients in 36 centers to CEA (n = 203), CAS (n = 197), or BMT (n = 113). The one-year rate of the major secondary endpoint did not significantly differ between groups (CEA 2.5%, CAS 3.0%, BMT 0.9%; p = 0.530) as well as rates of any stroke (CEA 3.9%, CAS 4.1%, BMT 0.9%; p = 0.256) and all-cause mortality (CEA 2.5%, CAS 1.0%, BMT 3.5%; p = 0.304). About half of all strokes occurred in the peri-interventional period. Higher albeit statistically non-significant rates of restenosis occurred in the stenting group (CEA 2.0% vs. CAS 5.6%; p = 0.068) without evidence of increased stroke rates.
INTERPRETATION


The low sample size of this prematurely stopped trial of 513 patients implies that its power is not sufficient to show that CEA or CAS is superior to a modern medical therapy (BMT) in the primary prevention of ischemic stroke in patients with an asymptomatic carotid stenosis up to one year after treatment. Also, no evidence for differences in safety between CAS and CEA during the first year after treatment could be derived. Follow-up will be performed up to five years. Data may be used for pooled analysis with ongoing trials.",2019,"The one-year rate of the major secondary endpoint did not significantly differ between groups (CEA 2.5%, CAS 3.0%, BMT 0.9%; p = 0.530) as well as rates of any stroke (CEA 3.9%, CAS 4.1%, BMT 0.9%; p = 0.256) and all-cause mortality (CEA 2.5%, CAS 1.0%, BMT 3.5%; p = 0.304).","['individuals with asymptomatic carotid artery stenosis', 'It was planned to enroll 3550 patients', '513 patients', 'patients with asymptomatic carotid artery stenosis of ≥70% European Carotid Surgery Trial (ECST) criteria']","['BMT', 'CEA or CAS', 'Angioplasty', 'carotid endarterectomy (CEA', 'CAS', 'CEA', 'CEA or carotid artery stenting (CAS']","['rates of any stroke', 'cumulative rate of any stroke (ischemic or hemorrhagic) or death', 'cause mortality', 'rate of any stroke and death', 'stroke rates', 'restenosis', 'Safety', 'ipsilateral ischemic stroke']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3494609', 'cui_str': 'Asymptomatic carotid artery stenosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0162577', 'cui_str': 'Angioplasty'}, {'cui': 'C0014099', 'cui_str': 'Carotid Endarterectomy'}, {'cui': 'C0007272', 'cui_str': 'Carotid Arteries'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]",513.0,0.252722,"The one-year rate of the major secondary endpoint did not significantly differ between groups (CEA 2.5%, CAS 3.0%, BMT 0.9%; p = 0.530) as well as rates of any stroke (CEA 3.9%, CAS 4.1%, BMT 0.9%; p = 0.256) and all-cause mortality (CEA 2.5%, CAS 1.0%, BMT 3.5%; p = 0.304).","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Reiff', 'Affiliation': '1 Department of Neurology, University Hospital of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Eckstein', 'Affiliation': '2 Department for Vascular and Endovascular Surgery, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Mansmann', 'Affiliation': '3 Institute of Medical Informatics, Biometry and Epidemiology, Ludwig Maximilian University Munich, Munich, Germany.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Jansen', 'Affiliation': '4 Department of Radiology and Neuroradiology, UKSH Campus Kiel, Kiel, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fraedrich', 'Affiliation': '5 Department of Vascular Surgery, University Hospital of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mudra', 'Affiliation': '6 Department of Internal Medicine, Städtisches Klinikum München-Neuperlach, Munich, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Böckler', 'Affiliation': '7 Department of Vascular Surgery, University Hospital of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': '8 Department of Internal Medicine, University Hospital of Homburg/Saar, Homburg, Germany.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Brückmann', 'Affiliation': '9 Department of Neuroradiology, Ludwig-Maximilians-Universität, Munich, Germany.'}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Debus', 'Affiliation': '10 Department of Vascular Surgery, University Hospital of Hamburg, Hamburg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Fiehler', 'Affiliation': '11 Department of Neuroradiology, University Hospital of Hamburg, Hamburg, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Lang', 'Affiliation': '12 Department of Vascular Surgery, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Mathias', 'Affiliation': '13 Department of Radiology, Klinikum Dortmund, Dortmund, Germany.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Ringelstein', 'Affiliation': '14 Department of Neurology, University Hospital of Münster, Münster, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schmidli', 'Affiliation': '15 Department of Vascular Surgery, University Hospital of Bern, Bern, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Stingele', 'Affiliation': '16 Department of Neurology, University of Kiel, Kiel, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zahn', 'Affiliation': '17 Department of Internal Medicine, Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': '18 Department of Angiology, University Hospital Freiburg, Bad Krozingen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hetzel', 'Affiliation': '19 Department of Neurology, University Hospital Freiburg, Freiburg, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Bodechtel', 'Affiliation': '20 Department of Neurology, University Hospital of Dresden, Dresden, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Binder', 'Affiliation': '21 Department of Neurology, UKSH Campus Kiel, Kiel, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Glahn', 'Affiliation': '22 Department of Neurology, Johannes Wesling Klinikum, Minden, Germany.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hacke', 'Affiliation': '1 Department of Neurology, University Hospital of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Ringleb', 'Affiliation': '1 Department of Neurology, University Hospital of Heidelberg, Heidelberg, Germany.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019833017']
772,30946974,Prognostic Implications for Adolescents With Depression Who Drop Out of Psychological Treatment During a Randomized Controlled Trial.,"OBJECTIVE


High therapy dropout rates among adolescents have been reported, but little is known about whether dropout is associated with poor outcomes. This study aimed to examine clinical outcomes in adolescents with depression who dropped out of psychological therapy and to determine whether this varied by treatment type.
METHOD


Data were drawn from the Improving Mood with Psychoanalytic and Cognitive Therapies (IMPACT) study, a randomized controlled trial, comparing a brief psychosocial intervention, cognitive-behavioral therapy, and short-term psychoanalytic psychotherapy in the treatment of adolescent major depression. The sample comprised 406 adolescents with a diagnosis of major depression, 169 of whom dropped out of treatment before the planned end of therapy. Primary outcome was self-report Mood and Feelings Questionnaire (MFQ); secondary outcomes were Health of the Nation Outcome Scale for Children and Adolescents, Revised Children's Manifest Anxiety Scale, Modified Leyton Obsessional Inventory, and clinical diagnosis.
RESULTS


During follow-up, there was a nonsignificant trend for dropouts to report higher depressive symptoms than completers. However, modeling showed insufficient evidence for an association between dropout and outcomes.
CONCLUSION


In contrast to studies of adult therapy, there was no strong evidence that adolescent patients who dropped out had poorer clinical outcomes compared with those who completed therapy, when dropout was defined as ending treatment without agreement of the therapist. This challenges us to understand why adolescents stop going to therapy, how dropout should be defined, and whether what is prescribed is what is always needed.
CLINICAL TRIAL REGISTRATION INFORMATION


Improving Mood and Preventing Relapse With Psychoanalytic Psychotherapy and Cognitive Behavior Therapy; http://www.isrctn.com/; 83033550.",2019,"In contrast to studies of adult therapy, there was no strong evidence that adolescent patients who dropped out had poorer clinical outcomes compared with those who completed therapy, when dropout was defined as ending treatment without agreement of the therapist.","['adolescents with depression who dropped out of psychological therapy', 'adolescent major depression', 'Adolescents With Depression', '406 adolescents with a diagnosis of major depression, 169 of whom dropped out of treatment before the planned end of therapy', 'Data were drawn from the Improving Mood with Psychoanalytic and Cognitive Therapies (IMPACT) study']","['psychosocial intervention, cognitive-behavioral therapy, and short-term psychoanalytic psychotherapy']","[""self-report Mood and Feelings Questionnaire (MFQ); secondary outcomes were Health of the Nation Outcome Scale for Children and Adolescents, Revised Children's Manifest Anxiety Scale, Modified Leyton Obsessional Inventory, and clinical diagnosis"", 'depressive symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies (procedure)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C4508986', 'cui_str': 'Improved mood'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0585661', 'cui_str': 'Health of the Nation Outcome Scale for children (assessment scale)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024720', 'cui_str': 'Manifest Anxiety Scale'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",406.0,0.112776,"In contrast to studies of adult therapy, there was no strong evidence that adolescent patients who dropped out had poorer clinical outcomes compared with those who completed therapy, when dropout was defined as ending treatment without agreement of the therapist.","[{'ForeName': 'Sally', 'Initials': 'S', 'LastName': ""O'Keeffe"", 'Affiliation': 'University College London, UK; Child Attachment and Psychological Therapies Research Unit (ChAPTRe), Anna Freud National Centre for Children and Families, London, UK. Electronic address: sally.okeeffe@ucl.ac.uk.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'University College London, UK; Child Attachment and Psychological Therapies Research Unit (ChAPTRe), Anna Freud National Centre for Children and Families, London, UK.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Goodyer', 'Affiliation': 'University of Cambridge, UK.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Kelvin', 'Affiliation': 'MindEd, The Royal College of Psychiatrists, London, UK.'}, {'ForeName': 'Bernadka', 'Initials': 'B', 'LastName': 'Dubicka', 'Affiliation': 'Pennine Care NHS Foundation Trust, Lancashire, UK; University of Manchester, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Midgley', 'Affiliation': 'University College London, UK.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.11.019']
773,31887743,Disease-Modifying Effects of a Novel Cathepsin K Inhibitor in Osteoarthritis: A Randomized Controlled Trial.,"Background


MIV-711 is a novel selective cathepsin K inhibitor with beneficial effects on bone and cartilage in preclinical osteoarthritis models.
Objective


To evaluate the efficacy, safety, and tolerability of MIV-711 in participants with symptomatic, radiographic knee osteoarthritis.
Design


26-week randomized, double-blind, placebo-controlled phase 2a study with a 26-week open-label safety extension substudy. (EudraCT: 2015-003230-26 and 2016-001096-73).
Setting


Six European sites.
Participants


244 participants with primary knee osteoarthritis, Kellgren-Lawrence grade 2 or 3, and pain score of 4 to 10 on a numerical rating scale (NRS).
Intervention


MIV-711, 100 (n = 82) or 200 (n = 81) mg daily, or matched placebo (n = 77). Participants (46 who initially received 200 mg/d and 4 who received placebo) received 200 mg of MIV-711 daily during the extension substudy.
Measurements


The primary outcome was change in NRS pain score. The key secondary outcome was change in bone area on magnetic resonance imaging (MRI). Other secondary end points included cartilage thickness on quantitative MRI and type I and II collagen C-telopeptide biomarkers. Outcomes were assessed over 26 weeks.
Results


Changes in NRS pain scores with MIV-711 were not statistically significant (placebo, -1.4; MIV-711, 100 mg/d, -1.7; MIV-711, 200 mg/d, -1.5). MIV-711 significantly reduced medial femoral bone area progression (P = 0.002 for 100 mg/d and 0.004 for 200 mg/d) and medial femoral cartilage thinning (P = 0.023 for 100 mg/d and 0.125 for 200 mg/d) versus placebo and substantially reduced bone and cartilage biomarker levels. Nine serious adverse events occurred in 6 participants (1 in the placebo group, 3 in the 100 mg group, and 2 in the 200 mg group); none were considered to be treatment-related.
Limitation


The trial was relatively short.
Conclusion


MIV-711 was not more effective than placebo for pain, but it significantly reduced bone and cartilage progression with a reassuring safety profile. This treatment may merit further evaluation as a disease-modifying osteoarthritis drug.
Primary Funding Source


Medivir.",2020,MIV-711 significantly reduced medial femoral bone area progression (P = 0.002 for 100 mg/d and 0.004 for 200 mg/d) and medial femoral cartilage thinning (P = 0.023 for 100 mg/d and 0.125 for 200 mg/d) versus placebo and substantially reduced bone and cartilage biomarker levels.,"['Participants\n\n\n244 participants with primary knee osteoarthritis, Kellgren-Lawrence grade 2 or 3, and pain score of 4 to 10 on a numerical rating scale (NRS', 'Osteoarthritis', 'participants with symptomatic, radiographic knee osteoarthritis', 'Participants (46 who initially received 200 mg/d and 4 who received']","['placebo', 'Placebo', 'Novel Cathepsin K Inhibitor', 'MIV-711']","['Nine serious adverse events', 'medial femoral cartilage thinning', 'NRS pain score', 'cartilage thickness on quantitative MRI and type I and II collagen C-telopeptide biomarkers', 'medial femoral bone area progression', 'bone and cartilage progression', 'NRS pain scores', 'change in bone area on magnetic resonance imaging (MRI', 'efficacy, safety, and tolerability', 'bone and cartilage biomarker levels']","[{'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0284930', 'cui_str': 'Cathepsin X'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0534110', 'cui_str': '(125I)mIV'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",244.0,0.588212,MIV-711 significantly reduced medial femoral bone area progression (P = 0.002 for 100 mg/d and 0.004 for 200 mg/d) and medial femoral cartilage thinning (P = 0.023 for 100 mg/d and 0.125 for 200 mg/d) versus placebo and substantially reduced bone and cartilage biomarker levels.,"[{'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom (P.G.C., S.R.K.).'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Bowes', 'Affiliation': 'Imorphics, Manchester, United Kingdom (M.A.B., A.B., G.G.).'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Kingsbury', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, United Kingdom (P.G.C., S.R.K.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Brett', 'Affiliation': 'Imorphics, Manchester, United Kingdom (M.A.B., A.B., G.G.).'}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Guillard', 'Affiliation': 'Imorphics, Manchester, United Kingdom (M.A.B., A.B., G.G.).'}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Rizoska', 'Affiliation': 'Medivir, Huddinge, Sweden (B.R., N.S., P.G., Å.J., C.W., R.B., J.Ö.).'}, {'ForeName': 'Niclas', 'Initials': 'N', 'LastName': 'Sjögren', 'Affiliation': 'Medivir, Huddinge, Sweden (B.R., N.S., P.G., Å.J., C.W., R.B., J.Ö.).'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Graham', 'Affiliation': 'Medivir, Huddinge, Sweden (B.R., N.S., P.G., Å.J., C.W., R.B., J.Ö.).'}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Jansson', 'Affiliation': 'Medivir, Huddinge, Sweden (B.R., N.S., P.G., Å.J., C.W., R.B., J.Ö.).'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Wadell', 'Affiliation': 'Medivir, Huddinge, Sweden (B.R., N.S., P.G., Å.J., C.W., R.B., J.Ö.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bethell', 'Affiliation': 'Medivir, Huddinge, Sweden (B.R., N.S., P.G., Å.J., C.W., R.B., J.Ö.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Öhd', 'Affiliation': 'Medivir, Huddinge, Sweden (B.R., N.S., P.G., Å.J., C.W., R.B., J.Ö.).'}]",Annals of internal medicine,['10.7326/M19-0675']
774,30889985,The influence of night-time electronic device use on subsequent sleep and propensity to be physically active the following day.,"This study investigated the effect of acute night-time blue-light exposure through electronic device use on sleep quality/quantity, exercise motivation and perceived exertion during exercise the following day. In a randomised, crossover design, 14 participants read a book on an iPad (light) or a hard-copy book (control) one hour before bedtime. Small but not significant differences in perceived sleep quality and quantity and measured sleep efficiency were found between light and control trials, suggesting that sleep may be negatively affected following one night of electronic device use. This did not impact motivation to exercise or perceived exertion during exercise the following day.",2019,"Small but not significant differences in perceived sleep quality and quantity and measured sleep efficiency were found between light and control trials, suggesting that sleep may be negatively affected following one night of electronic device use.",['14 participants read a book on an iPad (light) or a hard-copy book (control) one hour before bedtime'],"['acute night-time blue-light exposure through electronic device', 'night-time electronic device']","['sleep quality/quantity, exercise motivation and perceived exertion', 'sleep quality and quantity and measured sleep efficiency']","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0006002', 'cui_str': 'Books'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}]","[{'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0303896', 'cui_str': 'Blue light (physical force)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",14.0,0.0989921,"Small but not significant differences in perceived sleep quality and quantity and measured sleep efficiency were found between light and control trials, suggesting that sleep may be negatively affected following one night of electronic device use.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Driller', 'Affiliation': 'a Health, Sport and Human Performance , University of Waikato , Hamilton , New Zealand.'}, {'ForeName': 'Liis', 'Initials': 'L', 'LastName': 'Uiga', 'Affiliation': 'a Health, Sport and Human Performance , University of Waikato , Hamilton , New Zealand.'}]",Chronobiology international,['10.1080/07420528.2019.1588287']
775,31472414,Does pectoralis minor stretching provide additional benefit over an exercise program in participants with subacromial pain syndrome? A randomized controlled trial.,"BACKGROUND


Adaptive shortening of the pectoralis minor is one of the biomechanical mechanisms associated with subacromial pain syndrome (SPS).
OBJECTIVE


To compare the effects of an exercise program alone with an exercise program in combination with pectoralis minor stretching in participants with SPS.
DESIGN


Randomized controlled trial.
METHODS


Eighty adult participants with SPS were randomly allocated to two groups. The control group (n = 40) received a 12-week specific exercise program and the intervention group (n = 40) received the same program plus stretching exercises of the pectoralis minor muscle. The primary outcome measure was shoulder function assessed by a Constant-Murley questionnaire, and the secondary outcomes were the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, visual analog scale (VAS), and pectoralis minor resting length.
RESULTS


The present study shows no difference between the two interventions according to the Constant-Murley questionnaire (1.5 points; p = 0.58), VAS at rest (0.2 cm; p = 0.11), VAS at movement (0.5 cm; p = 0.08), and pectoralis minor resting length (0.3 cm; p = 0.06). The DASH questionnaire showed greater functional improvement in the control group (5.4 points; p = 0.02). Finally, only pectoralis minor length index showed difference statistical significant in favor of intervention group (0.3%; p = 0.04).
CONCLUSION


In the short-term, the addition of a program of stretching exercises of the pectoralis minor does not provide significant clinical benefit with respect to functional improvement or pain reduction in participants with SPS.
TRIAL REGISTRATION


Brazilian registry of clinical trials UTN number U1111-1210-3555. Registered 5 March 2018.",2019,The DASH questionnaire showed greater functional improvement in the control group (5.4 points; p = 0.02).,"['Eighty adult participants with SPS', 'participants with SPS', 'participants with subacromial pain syndrome']","['exercise program', 'specific exercise program and the intervention group (n\u202f=\u202f40) received the same program plus stretching exercises of the pectoralis minor muscle', 'exercise program alone with an exercise program']","['Constant-Murley questionnaire', 'shoulder function assessed by a Constant-Murley questionnaire, and the secondary outcomes were the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, visual analog scale (VAS), and pectoralis minor resting length', 'functional improvement', 'pain reduction']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4255078', 'cui_str': 'SPS'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",80.0,0.14676,The DASH questionnaire showed greater functional improvement in the control group (5.4 points; p = 0.02).,"[{'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Gutiérrez-Espinoza', 'Affiliation': 'Faculty of Health, Universidad de las Américas, Santiago, Chile; Physical Therapy Department, Clinical Hospital San Borja Arriarán, Santiago, Chile.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Araya-Quintanilla', 'Affiliation': 'Faculty of Health, Universidad de las Américas, Santiago, Chile; Faculty of Health, Universidad SEK, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Gutiérrez-Monclus', 'Affiliation': 'Orthopedic Surgeon, Instituto Traumatológico, Santiago, Chile.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Ríos-Riquelme', 'Affiliation': 'Department Sciences in Physical Activity, Universidad de Santiago, Santiago, Chile.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Álvarez-Bueno', 'Affiliation': 'Universidad de Castilla-La Mancha, Health and Social Research Center, Cuenca, Spain; Universidad Politécnica y Artística del Paraguay, Asunción, Paraguay. Electronic address: celia.alvarezbueno@uclm.es.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Martínez-Vizcaino', 'Affiliation': 'Universidad de Castilla-La Mancha, Health and Social Research Center, Cuenca, Spain; Facultad de Ciencias de la Salud, Universidad Autónoma de Chile, Talca, Chile.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Cavero-Redondo', 'Affiliation': 'Universidad de Castilla-La Mancha, Health and Social Research Center, Cuenca, Spain; Universidad Politécnica y Artística del Paraguay, Asunción, Paraguay.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2019.102052']
776,31714309,Prophylaxis of Wound Infections-antibiotics in Renal Donation (POWAR): A UK Multicentre Double Blind Placebo Controlled Randomised Trial.,"BACKGROUND


Postoperative infection after hand-assisted laparoscopic donor nephrectomy (HALDN) confers significant morbidity to a healthy patient group. Current UK guidelines cite a lack of evidence for routine antibiotic prophylaxis. This trial assessed if a single preoperative antibiotic dose could reduce post HALDN infections.
METHODS


Eligible donors were randomly and blindly allocated to preoperative single-dose intravenous co-amoxiclav or saline. The primary composite endpoint was clinical evidence of any postoperative infection at 30 days, including surgical site infection (SSI), urinary tract infection (UTI), and lower respiratory tract infection (LRTI).
FINDINGS


In all, 293 participants underwent HALDN (148 antibiotic arm and 145 placebo arm). Among them, 99% (291/293) completed follow-up. The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001). Superficial SSIs were 20.7% (30/145 patients) in the placebo group versus 10.1% (15/148 patients) in the antibiotic group (P = 0.012). LRTIs were 9% (13/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.046). UTIs were 4.1% (6/145) in the placebo group and 3.4% (5/148) in the antibiotic group (P = 0.72).Antibiotic prophylaxis conferred a 17.7% (95% confidence interval 7.2%-28.1%), absolute risk reduction in developing postoperative infection, with 6 donors requiring treatment to prevent 1 infection.
INTERPRETATION


Single-dose preoperative antibiotic prophylaxis dramatically reduces post-HALDN infection rates, mainly impacting SSIs and LRTIs.",2020,The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001).,"['healthy patient group', 'Eligible donors', '293 participants underwent HALDN (148 antibiotic arm and 145 placebo arm', 'Renal Donation (POWAR']","['hand-assisted laparoscopic donor nephrectomy (HALDN', 'Placebo', 'preoperative single-dose intravenous co-amoxiclav or saline', 'placebo']","['clinical evidence of any postoperative infection at 30 days, including surgical site infection (SSI), urinary tract infection (UTI), and lower respiratory tract infection (LRTI', 'LRTIs', 'Superficial SSIs', 'total infection rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4049936', 'cui_str': 'Donation'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0054066', 'cui_str': 'Amoxicillin / Clavulanate'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0392618', 'cui_str': 'Postoperative infection (disorder)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection (disorder)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",293.0,0.709113,The total infection rate was 40.7% (59/145) in the placebo group and 23% (34 of 148) in the antibiotic group (P = 0.001).,"[{'ForeName': 'Zubir', 'Initials': 'Z', 'LastName': 'Ahmed', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Uwechue', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Chandak', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'van Dellen', 'Affiliation': 'Dept of Renal and Pancreas Transplantation, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Barwell', 'Affiliation': 'Renal Transplant Unit, Derriford Hospital, Plymouth Hospitals NHS Trust, Plymouth, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Heap', 'Affiliation': ""Renal Transplant Unit, St. George's Hospital, London, UK.""}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Szabo', 'Affiliation': ""Department of Microbiology and Infection, Guy's & St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Hemsley', 'Affiliation': 'Department of Nephrology & Transplant Surgery, University Hospital of Wales, Cardiff & Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Olsburgh', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'Nicos', 'Initials': 'N', 'LastName': 'Kessaris', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}, {'ForeName': 'Nizam', 'Initials': 'N', 'LastName': 'Mamode', 'Affiliation': ""Department of Transplantation, Guy's & St Thomas' NHS Foundation Trust, King's College, London, UK.""}]",Annals of surgery,['10.1097/SLA.0000000000003666']
777,27888737,An intervention to improve sibling relationship quality among youth in foster care: Results of a randomized clinical trial.,"Sibling programming is an important part of a prevention framework, particularly for youth in foster care. After children are removed from their families and placed into foster care in the aftermath of maltreatment, the sibling relationship is often the most viable ongoing relationship available to the child, and may be critical to a youth's sense of connection, emotional support, and continuity. The promise of dyadic sibling programming in particular rests on the ability of interventions to enhance the quality of sibling relationships; yet little research exists that suggests that sibling interventions can improve relationship quality among foster youth. The primary aim of the current study was to examine the effects of a specific dyadic sibling-focused intervention for older and younger siblings on sibling relationship quality. One hundred sixty four dyads (328 youth) participated in the study, with each dyad consisting of an older sibling between 11 and 15 years of age at baseline and a younger sibling separated in age by less than 4 years. Hierarchical linear models were applied to self-reported, observer-reported and observational data over the 18-month study period. Findings suggest that the sibling intervention holds promise for improving sibling relationship quality among youth in foster care. Implications and future directions for research are discussed.",2017,The promise of dyadic sibling programming in particular rests on the ability of interventions to enhance the quality of sibling relationships; yet little research exists that suggests that sibling interventions can improve relationship quality among foster youth.,"['older and younger siblings on sibling relationship quality', 'One hundred sixty four dyads (328 youth) participated in the study, with each dyad consisting of an older sibling between 11 and 15 years of age at baseline and a younger sibling separated in age by less than 4 years', 'youth in foster care']",['specific dyadic sibling-focused intervention'],['sibling relationship quality'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0580718', 'cui_str': 'Foster care procedures (procedure)'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}]","[{'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.0239519,The promise of dyadic sibling programming in particular rests on the ability of interventions to enhance the quality of sibling relationships; yet little research exists that suggests that sibling interventions can improve relationship quality among foster youth.,"[{'ForeName': 'Brianne H', 'Initials': 'BH', 'LastName': 'Kothari', 'Affiliation': 'Oregon State University, Cascades, United States. Electronic address: Brianne.kothari@osucascades.edu.'}, {'ForeName': 'Bowen', 'Initials': 'B', 'LastName': 'McBeath', 'Affiliation': 'Portland State University, United States; Oregon Social Learning Center, United States.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sorenson', 'Affiliation': 'Portland State University, United States.'}, {'ForeName': 'Lew', 'Initials': 'L', 'LastName': 'Bank', 'Affiliation': 'Portland State University, United States; Oregon Social Learning Center, United States.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Waid', 'Affiliation': 'University of Minnesota, Twin Cities, United States.'}, {'ForeName': 'Sara Jade', 'Initials': 'SJ', 'LastName': 'Webb', 'Affiliation': 'Portland State University, United States.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Steele', 'Affiliation': 'Portland State University, United States.'}]",Child abuse & neglect,['10.1016/j.chiabu.2016.11.010']
778,30928162,Could Differences in Treatment Between Trial Arms Explain the Reduction in Prostate Cancer Mortality in the European Randomized Study of Screening for Prostate Cancer?,"BACKGROUND


Differential treatment between trial arms has been suggested to bias prostate cancer (PC) mortality in the European Randomized Study of Screening for Prostate Cancer (ERSPC).
OBJECTIVE


To quantify the contribution of treatment differences to the observed PC mortality reduction between the screening arm (SA) and the control arm (CA).
DESIGN, SETTING, AND PARTICIPANTS


A total of 14 136 men with PC (SA: 7310; CA: 6826) in the core age group (55-69yr) at 16yr of follow-up.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The outcomes measurements were observed and estimated numbers of PC deaths by treatment allocation in the SA and CA, respectively. Primary treatment allocation was modeled using multinomial logistic regression adjusting for center, age, year, prostate-specific antigen, grade group, and tumor-node-metastasis stage. For each treatment, logistic regression models were fitted for risk of PC death, separately for the SA and CA, and using the same covariates as for the treatment allocation model. Treatment probabilities were multiplied by estimated PC death risks for each treatment based on one arm, and then summed and compared with the observed number of deaths.
RESULTS AND LIMITATIONS


The difference between the observed and estimated treatment distributions (hormonal therapy, radical prostatectomy, radiotherapy, and active surveillance/watchful waiting) in the two arms ranged from -3.3% to 3.3%. These figures, which represent the part of the treatment differences between arms that cannot be explained by clinicopathological differences, are small compared with the observed differences between arms that ranged between 7.2% and 10.1%. The difference between the observed and estimated numbers of PC deaths among men with PC was 0.05% (95% confidence interval [CI] -0.1%, 0.2%) when applying the CA model to the SA, had the two groups received identical primary treatment, given their clinical characteristics. When instead applying the SA model to the CA, the difference was, as expected, very similar-0.01% (95% CI -0.3%, 0.2%). Consistency of the results of the models demonstrates the robustness of the modeling approach. As the observed difference between trial arms was 4.2%, our findings suggest that differential treatment explains only a trivial proportion of the main findings of ERSPC. A limitation of the study is that only data on primary treatment were available.
CONCLUSIONS


Use of prostate-specific antigen remains the predominant explanation for the reduction in PC mortality seen in the ERSPC trial and is not attributable to differential treatment between trial arms.
PATIENT SUMMARY


This study shows that prostate cancer deaths in the European screening trial (European Randomized Study of Screening for Prostate Cancer) were prevented because men were diagnosed and treated earlier through prostate-specific antigen screening, and not because of different, or better, treatment in the screening arm compared with the control arm.",2019,"When instead applying the SA model to the CA, the difference was, as expected, very similar-0.01% (95% CI -0.3%, 0.2%).",['A total of 14 136 men with PC (SA: 7310; CA: 6826) in the core age group (55-69yr) at 16yr of follow-up'],[],"['numbers of PC deaths', 'PC deaths', 'PC death risks', 'radical prostatectomy, radiotherapy, and active surveillance/watchful waiting', 'PC mortality reduction', 'Prostate Cancer Mortality']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C0700325', 'cui_str': 'Waitings, Watchful'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",14136.0,0.0787604,"When instead applying the SA model to the CA, the difference was, as expected, very similar-0.01% (95% CI -0.3%, 0.2%).","[{'ForeName': 'Sigrid V', 'Initials': 'SV', 'LastName': 'Carlsson', 'Affiliation': 'Department of Surgery (Urology Service), Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sweden.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Månsson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sweden.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Moss', 'Affiliation': 'Centre for Cancer Prevention, Queen Mary University of London, London, UK.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kwiatkowski', 'Affiliation': 'Department of Urology, Kantonsspital Aarau, Aarau, Switzerland; Department of Urology, Academic Hospital Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Recker', 'Affiliation': 'Department of Urology, Kantonsspital Aarau, Aarau, Switzerland.'}, {'ForeName': 'Teuvo L J', 'Initials': 'TLJ', 'LastName': 'Tammela', 'Affiliation': 'Department of Urology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bangma', 'Affiliation': 'Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Monique J', 'Initials': 'MJ', 'LastName': 'Roobol', 'Affiliation': 'Department of Urology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'School of Health Sciences, Tampere University, Tampere, Finland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Hugosson', 'Affiliation': 'Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sweden; Region Västra Götaland, Sahlgrenska University Hospital, Department of Urology, Gothenborg, Sweden. Electronic address: jonas@urol.se.'}]",European urology,['10.1016/j.eururo.2019.03.010']
779,27179823,Withdrawal exposure with withdrawal regulation training for smoking cessation: a randomized controlled pilot trial.,"INTRODUCTION


Although withdrawal processes form a key motivational basis for cigarette use, smoking cessation treatments appear to exert only modest effects on withdrawal. One treatment option for further reducing withdrawal severity would be to provide smokers with withdrawal regulation training. The objective of this study was to pilot a smoking cessation intervention comprising withdrawal exposure with withdrawal regulation training.
METHODS


Adult smokers (N=80) were randomized to one of two conditions: 1) Withdrawal Exposure with Withdrawal Regulation Training (WT), which included the development and application of individualized withdrawal regulation strategies over four separate sessions that spanned the first four hours of abstinence; 2) or Relaxation Control (RC) training, which controlled for the therapeutic contact of WT. All sessions occurred before the quit date, after which differential treatment was discontinued and all participants received brief counseling, nicotine replacement therapy, and self-help literature. Biochemically-confirmed (CO≤3) seven-day point-prevalence abstinence was assessed at Months 2 and 3 after end-of-treatment.
RESULTS


Treatment completion and ratings of credibility and efficacy were high and equivalent across conditions. 22.2% of participants in the WT condition were abstinent at both time points, whereas 0% and 4.2% of participants in the RC condition were abstinent at Months 2 and 3 (Month 3 OR=6.5 [0.73, 59.19]). In-session withdrawal ratings suggested WT improved regulation of withdrawal symptoms, which were in turn associated with abstinence.
CONCLUSIONS


This small pilot study suggests that WT promotes abstinence by enhancing withdrawal regulation. Results warrant further investigation of this innovative treatment approach.",2016,"22.2% of participants in the WT condition were abstinent at both time points, whereas 0% and 4.2% of participants in the RC condition were abstinent at Months 2 and 3 (Month 3 OR=6.5 [0.73, 59.19]).","['Adult smokers (N=80', 'smoking cessation']","['Withdrawal exposure with withdrawal regulation training', 'smoking cessation intervention comprising withdrawal exposure with withdrawal regulation training', 'brief counseling, nicotine replacement therapy, and self-help literature', 'Relaxation Control (RC) training', 'Withdrawal Exposure with Withdrawal Regulation Training (WT']","['regulation of withdrawal symptoms', 'ratings of credibility and efficacy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0023866', 'cui_str': 'Literature'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal Symptoms'}]",80.0,0.0360509,"22.2% of participants in the WT condition were abstinent at both time points, whereas 0% and 4.2% of participants in the RC condition were abstinent at Months 2 and 3 (Month 3 OR=6.5 [0.73, 59.19]).","[{'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Hendricks', 'Affiliation': 'University of Alabama at Birmingham, School of Public Health, Department of Health Behavior, 227L Ryals Public Health Building, 1665 University Blvd., Birmingham, AL 35294 USA. Electronic address: phendricks@uab.edu.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Hall', 'Affiliation': 'University of California, San Francisco, Department of Psychiatry, 401 Parnassus Ave., San Francisco, California 94143 USA. Electronic address: sharon.hall@ucsf.edu.'}, {'ForeName': 'Leslie R', 'Initials': 'LR', 'LastName': 'Tyus', 'Affiliation': 'University of Alabama at Birmingham, School of Public Health, Department of Health Behavior, 227L Ryals Public Health Building, 1665 University Blvd., Birmingham, AL 35294 USA. Electronic address: lware200@uab.edu.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Thorne', 'Affiliation': 'University of Alabama at Birmingham, School of Public Health, Department of Health Behavior, 227L Ryals Public Health Building, 1665 University Blvd., Birmingham, AL 35294 USA. Electronic address: cbthorne@uab.edu.'}, {'ForeName': 'Sara N', 'Initials': 'SN', 'LastName': 'Lappan', 'Affiliation': 'University of Alabama at Birmingham, School of Public Health, Department of Health Behavior, 227L Ryals Public Health Building, 1665 University Blvd., Birmingham, AL 35294 USA. Electronic address: lappansa@uab.edu.'}, {'ForeName': 'Megan V', 'Initials': 'MV', 'LastName': 'McMurray', 'Affiliation': 'University of Alabama at Birmingham, Department of Psychiatry and Behavioral Neurobiology, Sparks Center 1016, 1720 2nd Ave. South, Birmingham, AL 35294 USA. Electronic address: mvmcmurr@uab.edu.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Bailey', 'Affiliation': 'University of AL at Birmingham, School of Medicine, Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine, 1720 2nd Ave. S., Birmingham, AL 35294 USA. Electronic address: wcbailey@uab.edu.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Cropsey', 'Affiliation': 'University of Alabama at Birmingham, Department of Psychiatry and Behavioral Neurobiology, Sparks Center 1016, 1720 2nd Ave. South, Birmingham, AL 35294 USA. Electronic address: kcropsey@uab.edu.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'University of Wisconsin, School of Medicine and Public Health, Center for Tobacco Research and Intervention, 1930 Monroe St. Suite 200, Madison, Wisconsin 53711 USA. Electronic address: tbb@ctri.wisc.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2016.04.022']
780,31488260,Effectiveness of a self-management programme in the treatment of antivitamin K oral anticoagulants. A feasibility study.,"BACKGROUND AND OBJECTIVES


To compare the efficacy of a self-monitoring programme vs. the conventional method used before the intervention in maintaining the international normalised ratio (INR) in the therapeutic range in patients receiving oral anticoagulants, as well as complications, quality of life and the time invested in the tests.
PATIENTS AND METHODS


Pre-pospilot and feasibility study. The study included 15 patients over the age of 18 years who had been attending the monitoring programme for more than 6months. In the pre phase, patients performed the tests and follow-up in the outpatient clinic. After conducting an individual training session with each patient to teach them how to perform venipuncture, use the coagulometer, manage dosing tables and subsequent follow-up from the virtual clinic, we compared the percentage of in-range INR tests, complications, quality of life, and the time invested in performing the tests pre- (conventional) and post-intervention (intervention for self-monitoring).
RESULTS


The percentage of INR tests in the therapeutic range was significantly higher in the post-phase than in the pre-phase (65.6% vs. 37.8%, p<.001). Likewise, the incidence of both minor and serious complications decreased in the post-phase (20% vs. 0%, and 6.7% vs. 0%, respectively). Finally, all 5dimensions of the quality of life questionnaire improved significantly, while the time invested decreased.
CONCLUSIONS


In our experience, OAT self-monitoring is associated with a significant improvement in patient management, a reduction in the rate of complications, improved quality of life and timesaving.",2020,"The percentage of INR tests in the therapeutic range was significantly higher in the post-phase than in the pre-phase (65.6% vs. 37.8%, p<.001).","['15 patients over the age of 18 years who had been attending the monitoring programme for more than 6months', 'patients receiving oral anticoagulants']","['conventional) and post-intervention', 'self-management programme']","['incidence of both minor and serious complications', 'quality of life questionnaire', 'rate of complications, improved quality of life and timesaving', 'percentage of INR tests']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.0260948,"The percentage of INR tests in the therapeutic range was significantly higher in the post-phase than in the pre-phase (65.6% vs. 37.8%, p<.001).","[{'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Vall Vargas', 'Affiliation': 'Departamento de Hematología, Althaia-Xarxa Assistencial Universitària de Manresa, Manresa, Barcelona, España. Electronic address: avall@althaia.cat.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Altes Hernandez', 'Affiliation': 'Departamento de Hematología, Althaia-Xarxa Assistencial Universitària de Manresa, Manresa, Barcelona, España.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Arnau', 'Affiliation': 'Departamento de Investigación e Innovación, Althaia-Xarxa Assistencial Universitària de Manresa, Manresa, Barcelona, España.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Constans Cots', 'Affiliation': 'Departamento de Hematología, Althaia-Xarxa Assistencial Universitària de Manresa, Manresa, Barcelona, España.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Gallart Fernández-Puebla', 'Affiliation': 'Departamento de Enfermería, Facultad de Medicina y Ciencias de la Salud, Universitat Internacional de Catalunya, Barcelona, Grupo de Investigación Emergente en Educación en Salud UICBarcelona, 2017 SGR 141.'}, {'ForeName': 'María Ángeles', 'Initials': 'MÁ', 'LastName': 'de Juan Pardo', 'Affiliation': 'Departamento de Enfermería, Facultad de Medicina y Ciencias de la Salud, Universitat Internacional de Catalunya, Barcelona, Grupo de Investigación Emergente en Educación en Salud UICBarcelona, 2017 SGR 141.'}]",Medicina clinica,['10.1016/j.medcli.2019.06.016']
781,31683226,Effectiveness of a primary care nurse delivered educational intervention for patients with type 2 diabetes mellitus in promoting metabolic control and compliance with long-term therapeutic targets: Randomised controlled trial.,"BACKGROUND


Systematic reviews and meta-analyses have shown very different values for the effectiveness of education in type 2 diabetes mellitus. However, the achievement of therapeutic targets after educational programs has been poorly evaluated.
OBJECTIVE


Evaluate the effectiveness of a structured and individualised education program for type 2 diabetes, provided by a primary care nurse, which featured educational reinforcements and family support to achieve metabolic control, and long-term therapeutic targets.
METHODS


Randomised controlled clinical trial with two arms: Intervention and control group. The intervention consisted of six face-to-face sessions of 30 min and follow-ups after 12 and 24 months for 236 participants with type 2 diabetes mellitus in a primary care setting in Andalusia (Spain). The primary outcome variables were the values and achievement of the type 2 diabetes mellitus control targets established by the American Diabetes Association: Glycated haemoglobin, fasting blood glucose, total cholesterol, low-density lipoprotein-cholesterol, high-density lipoprotein-cholesterol, triglycerides, systolic and diastolic blood pressure. The secondary outcome variable was body mass index.
RESULTS


From an overall total of 236 participants, 54.2% were male and the average age was 65.1 ± 9.5. After 12 months, the glycated haemoglobin level and systolic blood pressure decreased in the intervention group. After 24 months, the following variables significantly improved among the intervention group participants: basal glycemia, glycated haemoglobin, total cholesterol low-density lipoprotein cholesterol, and diastolic blood pressure. The glycated haemoglobin target (<7%) was better achieved in the intervention group than in the control group (35.2% vs 24.7%, p < 0.003). The rest of the targets were not met.
CONCLUSION


Continual diabetes education with reinforcement sessions provided by a nurse achieved reductions in glycated haemoglobin, basal glycaemia, total cholesterol, low-density lipoprotein-cholesterol and systolic blood pressure in both the medium and long term. It also increased the proportion of participants who achieved the therapeutic target of glycated haemoglobin.",2020,"The glycated haemoglobin target (<7%) was better achieved in the intervention group than in the control group (35.2% vs 24.7%, p < 0.003).","['patients with type 2 diabetes mellitus', '236 participants with type 2 diabetes mellitus in a primary care setting in Andalusia (Spain', '236 participants, 54.2% were male and the average age was 65.1\u202f±\u202f9.5']","['primary care nurse delivered educational intervention', 'structured and individualised education program']","['values and achievement of the type 2 diabetes mellitus control targets established by the American Diabetes Association', 'glycated haemoglobin target', 'body mass index', 'glycated haemoglobin, basal glycaemia, total cholesterol, low-density lipoprotein-cholesterol and systolic blood pressure', 'Glycated haemoglobin, fasting blood glucose, total cholesterol, low-density lipoprotein-cholesterol, high-density lipoprotein-cholesterol, triglycerides, systolic and diastolic blood pressure', 'basal glycemia, glycated haemoglobin, total cholesterol low-density lipoprotein cholesterol, and diastolic blood pressure', 'glycated haemoglobin level and systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4517808', 'cui_str': '54.2 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0860920', 'cui_str': 'Cholesterol low'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",236.0,0.0577758,"The glycated haemoglobin target (<7%) was better achieved in the intervention group than in the control group (35.2% vs 24.7%, p < 0.003).","[{'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'De la Fuente Coria', 'Affiliation': 'Primary Health Care District of Bay of Cádiz-La Janda, Andalucía, Spain. Electronic address: delafuentecoriam@yahoo.es.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cruz-Cobo', 'Affiliation': 'Faculty of Nursing and Physiotherapy, University of Cádiz, Spain. Electronic address: celia.cruz@uca.es.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Santi-Cano', 'Affiliation': 'Research Group on Nutrition: Molecular, Pathophysiological and Social Issues, University of Cádiz, Avda. Ana de Viya, 52, 11009 Cádiz, Spain. Electronic address: mariajose.santi@uca.es.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2019.103417']
782,30870245,Predictors of Exercise Training and Physical Activity Adherence in People Recently Hospitalized With Heart Failure: A BRIEF REPORT.,"PURPOSE


For individuals with heart failure (HF), frequent attendance at exercise training programs and meeting physical activity (PA) guidelines are significantly associated with improvements in 6-min walk distance. Despite the evidence, adherence to exercise interventions remains poor. The aim of this study was to identify predictors of these 2 variables in patients recently hospitalized with HF.
METHODS


In this substudy of the Exercise Joins Education: Combined Therapy to Improve Outcomes in Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk. Intervention group participants additionally undertook twice weekly supervised exercise training. Primary outcomes were frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines (150 min/wk of moderate intensity exercise) at 12 wk. Participant and clinical characteristics were analyzed using a logistic regression model to identify significant predictors of each outcome.
RESULTS


A total of 278 participants provided PA data and 140 contributed attendance data. New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03). Predictors of meeting PA guidelines at follow-up included new HF diagnosis (OR = 2.4; 95% CI, 1.2-4.8, P = .013), and being physically active at baseline (OR = 2.7; 95% CI, 1.3-5.6; P = .007). Gender, symptom severity, multimorbidity, and disability were not significantly associated with either outcome in multivariate analysis.
CONCLUSION


To improve adherence, specific strategies may be required for patients with decompensated HF and those physically inactive at time of referral.",2019,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","['278 participants provided PA data and 140 contributed attendance data', 'Newly-discharged Heart Failure (EJECTION-HF) trial, all participants were enrolled in a HF disease management program, including weekly review of a home exercise program for 12 wk', 'individuals with heart failure (HF', 'patients with decompensated HF and those physically inactive at time of referral', 'People Recently Hospitalized With Heart Failure']","['Exercise Training and Physical Activity Adherence', 'supervised exercise training']","['Gender, symptom severity, multimorbidity, and disability', 'frequent exercise training program attendance (≥12 sessions) and attainment of PA guidelines', 'frequent program attendance']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0336969', 'cui_str': 'Ejection (qualifier value)'}, {'cui': 'C1303150', 'cui_str': 'Disease management program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",278.0,0.0700865,"New diagnosis of HF was a significant predictor of frequent program attendance (OR = 2.3; 95% CI, 1.1-4.7; P = .03).","[{'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Adsett', 'Affiliation': ""Heart Support Service (Ms Adsett) and Departments of Physiotherapy (Ms Adsett) and Internal Medicine and Aged Care (Dr Mudge), Royal Brisbane and Women's Hospital, Brisbane, Australia; School of Allied Health Sciences, Griffith University, Gold Coast, Australia (Ms Adsett and Dr Morris); Menzies Health Institute, Queensland, Australia (Ms Adsett and Dr Morris); Metro North Hospital and Health Service, The Prince Charles Hospital, Allied Health Research Collaborative, Queensland, Australia (Dr Morris); and University of Queensland Faculty of Medicine, Brisbane, Queensland, Australia (Dr Mudge).""}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Mudge', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000407']
783,31703722,Initial loss to follow up among tuberculosis patients: the role of Ward-Based Outreach Teams and short message service (SMS) technology (research proposal).,"INTRODUCTION


Tuberculosis (TB) is a problem in South Africa. Initial loss to follow up (LTFU) among TB patients is high varying between 14.9 and 18%. Some of the reasons for this are: lack of proper communication between patient and staff on next steps after testing, not aware that results are ready; and other competing priorities. Receiving reminder messages that result is ready is an intervention that can be explored to reduce initial LTFU. This can be through either receiving a note from the Ward-Based Outreach Teams (WBOTs) or via short message service (SMS) advising the patient to collect test result at the facility. This proposal aims to assess the effectiveness of WBOTs or SMS technology in reducing TB initial LTFU.
METHODS


This will be a mixed methods approach. In depth interviews with WBOT Managers and TB Program Managers will be conducted. Focus group discussions with WBOT members will also be conducted. Two interventions (enhanced WBOTs/SMS technology) will be tested using a 3 arm randomized controlled trial (standard of care, SMS technology or enhanced WBOTs). The WBOTs will deliver paper note reminders while SMS intervention will entail sending reminder SMS messages to patients as soon as TB results are ready.",2019,The WBOTs will deliver paper note reminders while SMS intervention will entail sending reminder SMS messages to patients as soon as TB results are ready.,[],[],['Initial loss to follow up (LTFU'],[],[],"[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.10956,The WBOTs will deliver paper note reminders while SMS intervention will entail sending reminder SMS messages to patients as soon as TB results are ready.,"[{'ForeName': 'Judith R M', 'Initials': 'JRM', 'LastName': 'Mwansa-Kambafwile', 'Affiliation': 'Department of Public Health, University of Witwatersrand, Johannesburg, South Africa. judy.mwansa@gmail.com.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Chasela', 'Affiliation': 'Department of Public Health, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nazir', 'Initials': 'N', 'LastName': 'Ismail', 'Affiliation': 'Centre for Tuberculosis, National Institute of Communicable Diseases, Johannesburg, South Africa.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Menezes', 'Affiliation': 'Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.'}]",BMC research notes,['10.1186/s13104-019-4757-3']
784,30682576,Changing Patient Mindsets about Non-Life-Threatening Symptoms During Oral Immunotherapy: A Randomized Clinical Trial.,"BACKGROUND


Oral immunotherapy (OIT) can lead to desensitization to food allergens, but patients can experience treatment-related symptoms of allergic reactions that cause anxiety and treatment dropout. Interventions to improve OIT for patients are needed.
OBJECTIVE


To determine whether fostering the mindset that non-life-threatening symptoms during OIT can signal desensitization improves treatment experience and outcomes.
METHODS


In a randomized, blinded, controlled phase II study, 50 children/adolescents (28% girls, aged 7-17 years, M = 10.82, standard deviation = 3.01) completed 6-month OIT for peanut allergies. Patients and their parent(s) had monthly clinic visits at the Sean N. Parker Center for Allergy and Asthma Research between January 5, 2017, and August 3, 2017. All families received identical symptom management training. In a 1:1 approach, 24 patients and their families were informed that non-life-threatening symptoms during OIT were unfortunate side effects of treatment, and 26 patients and their families were informed that non-life-threatening symptoms could signal desensitization. Families participated in activities to reinforce these symptom mindsets.
RESULTS


Compared with families informed that symptoms are side effects, families informed that symptoms can signal desensitization were less anxious (B = -0.46, 95% confidence interval [CI]: -0.76 to -0.16; P = .003), less likely to contact staff about symptoms (5/24 [9.4%] vs 27/154 [17.5%] instances; P = .036), experienced fewer non-life-threatening symptoms as doses increased (B Interaction  = -0.54, 95% CI: -0.83 to -0.27; P < .001), less likely to skip/reduce doses (1/26 [4%] vs 5/24 [21%] patients; P = .065), and showed a greater increase in patient peanut-specific blood IgG4 levels (B Interaction  = 0.76, 95% CI: 0.36 to 1.17; P < .001).
CONCLUSIONS


Fostering the mindset that symptoms can signal desensitization improves OIT experience and outcomes. Changing how providers inform patients about non-life-threatening symptoms is a promising avenue for improving treatment.",2019,"Compared with families informed that symptoms are side effects, families informed that symptoms can signal desensitization were less anxious (B = -0.46, 95% confidence interval [CI]: -0.76 to -0.16; P = .003), less likely to contact staff about symptoms (5/24 [9.4%] vs 27/154 [17.5%] instances; P = .036), experienced fewer non-life-threatening symptoms as doses increased (B Interaction  = -0.54, 95% CI: -0.83 to -0.27; P < .001), less likely to skip/reduce doses (1/26 [4%] vs 5/24 [21%] patients; P = .065), and showed a greater increase in patient peanut-specific blood IgG4 levels (B Interaction  = 0.76, 95% CI: 0.36 to 1.17; P < .001).
","['Patients and their parent(s) had monthly clinic visits at the Sean N. Parker Center for Allergy and Asthma Research between January 5, 2017, and August 3, 2017', '24 patients and their families', '50 children/adolescents (28% girls, aged 7-17 years, M\xa0= 10.82, standard deviation\xa0= 3.01) completed 6-month OIT for peanut allergies']","['Oral Immunotherapy', 'Oral immunotherapy (OIT', 'identical symptom management training']",['patient peanut-specific blood IgG4 levels'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0035168'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0559470', 'cui_str': 'Groundnut Hypersensitivity'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C1536570', 'cui_str': 'Symptom management (procedure)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030736', 'cui_str': 'Peanuts'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0005768'}, {'cui': 'C0020860', 'cui_str': 'IgG4'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",50.0,0.122049,"Compared with families informed that symptoms are side effects, families informed that symptoms can signal desensitization were less anxious (B = -0.46, 95% confidence interval [CI]: -0.76 to -0.16; P = .003), less likely to contact staff about symptoms (5/24 [9.4%] vs 27/154 [17.5%] instances; P = .036), experienced fewer non-life-threatening symptoms as doses increased (B Interaction  = -0.54, 95% CI: -0.83 to -0.27; P < .001), less likely to skip/reduce doses (1/26 [4%] vs 5/24 [21%] patients; P = .065), and showed a greater increase in patient peanut-specific blood IgG4 levels (B Interaction  = 0.76, 95% CI: 0.36 to 1.17; P < .001).
","[{'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Howe', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, Calif. Electronic address: Lchowe@stanford.edu.'}, {'ForeName': 'Kari A', 'Initials': 'KA', 'LastName': 'Leibowitz', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, Calif.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Perry', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, Calif.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Bitler', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University, El Camino Hospital, Mountain View, Calif.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Block', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University, El Camino Hospital, Mountain View, Calif.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Department of Global Health & Social Medicine, Harvard Medical School, Boston, Mass.'}, {'ForeName': 'Kari C', 'Initials': 'KC', 'LastName': 'Nadeau', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University, El Camino Hospital, Mountain View, Calif.'}, {'ForeName': 'Alia J', 'Initials': 'AJ', 'LastName': 'Crum', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, Calif.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.01.022']
785,30811620,"Clinical and histological evaluation of a single high energy microwave treatment for primary axillary hyperhidrosis in Asians: A prospective, randomized, controlled, split-area comparative trial.","BACKGROUND AND OBJECTIVES


Microwave treatment is an effective non-invasive treatment option for primary axillary hyperhidrosis (PAH), but the treatment parameters vary and no histopathological studies have been performed to validate clinical outcomes. This study investigated its efficacy and safety and histopathological changes after a single microwave treatment at the maximum energy level for PAH in Asians.
MATERIALS AND METHODS


A prospective, clinical, and histological split-area randomized controlled trial (RCT) was performed in Japan. Twenty-six subjects underwent a single microwave treatment at the maximum energy level 5 (5.8 GHz/axilla) on the randomized side of axillae. The primary outcome was the mean difference between both sides in the improvement of modified single-underarm Hyperhidrosis Disease Severity Scale (msHDSS) scores over the course of the 12-month study period from baseline. The secondary outcomes were; the percentage of responders with at least a 2-point drop in the msHDSS score of 3 or 4 group or with a 1-point drop in the msHDSS score of 2 group; the percentage of responders with at least a 75% reduction in sweat weight over 12 months; recurrence rate; and adverse effects. We also performed a histological assessment for 13 selected subjects.
RESULTS


Twenty-four subjects completed the study. There were statistically significant differences in improvement of msHDSS scores between the microwave-treated and control sides (P < 0.05) from baseline at 0.5, 1, 3, 6, and 12 months. In the msHDSS score of 3 or 4 group, the percentage of responders with at least a 2-point drop on the microwave-treated side versus control side was 72.2 versus 11.1% (P < 0.05) at 1 month, 83.3 versus 5.6% (P < 0.05) at 3 months, 61.1 versus 38.9% (P = 0.317) at 6 months and 38.9 versus 16.7% (P = 0.264) at 12 months. The percentage of responders with at least a 75% reduction in sweat weight on the microwave-treated side versus control side was 75.0 versus 37.5% at 1 month, 75.0 versus 29.2% at 3 months, 83.3 versus 50.0% at 6 months and 70.8 versus 33.3% at 12 months (all P < 0.05). Recurrence on the microwave-treated side was observed in 4.2% and 12.5% of 24 subjects at 3 and 12 months, respectively. No serious side-effects were noted. Histology showed the diameter and density of secretory eccrine glands and nerve fiber lengths around eccrine glands were significantly decreased after treatment compared to baseline (P = 0.002, 0.027, 0.003, respectively).
CONCLUSIONS


A single-session microwave treatment at the maximum energy level significantly improved the PAH of Japanese patients and had minimal side effects. This technique demonstrates that diminished size of secretory eccrine glands and nerve fiber degeneration could be useful markers for predicting the efficacy of the treatment. Lasers Surg. Med. 9999:1-8, 2019. © 2019 Wiley Periodicals, Inc.",2019,A single-session microwave treatment at the maximum energy level significantly improved the PAH of Japanese patients and had minimal side effects.,"['13 selected subjects', 'Twenty-four subjects completed the study', 'PAH in Asians', 'primary axillary hyperhidrosis in Asians', 'primary axillary hyperhidrosis (PAH', '2019']",[],"['msHDSS score', 'Recurrence on the microwave-treated side', 'serious side-effects', 'msHDSS scores', 'recurrence rate; and adverse effects', 'sweat weight', 'percentage of responders with at least a 2-point drop in the msHDSS score', 'efficacy and safety and histopathological changes', 'diameter and density of secretory eccrine glands and nerve fiber lengths around eccrine glands', 'modified single-underarm Hyperhidrosis Disease Severity Scale (msHDSS) scores']","[{'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0026051', 'cui_str': 'Microwaves'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1278297', 'cui_str': 'Sweat weight'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0013492', 'cui_str': 'Eccrine Glands'}, {'cui': 'C0027749', 'cui_str': 'Nerve Fibers'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4018983', 'cui_str': 'Underarm'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}]",,0.0496845,A single-session microwave treatment at the maximum energy level significantly improved the PAH of Japanese patients and had minimal side effects.,"[{'ForeName': 'Chikako', 'Initials': 'C', 'LastName': 'Kaminaka', 'Affiliation': 'Department of Dermatology, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Mikita', 'Affiliation': 'Department of Dermatology, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Inaba', 'Affiliation': 'Department of Dermatology, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Kayo', 'Initials': 'K', 'LastName': 'Kunimoto', 'Affiliation': 'Department of Dermatology, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Hisako', 'Initials': 'H', 'LastName': 'Okuhira', 'Affiliation': 'Department of Dermatology, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Jinnin', 'Affiliation': 'Department of Dermatology, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Bunsho', 'Initials': 'B', 'LastName': 'Kao', 'Affiliation': 'Department of Plastic Surgery, Tenjinshita Dermatology and Plastic Surgery, Tokyo, Japan.'}, {'ForeName': 'Ryuzaburo', 'Initials': 'R', 'LastName': 'Tanino', 'Affiliation': 'Department of Plastic Surgery, Tenjinshita Dermatology and Plastic Surgery, Tokyo, Japan.'}, {'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Tanioka', 'Affiliation': 'Wakayama Medical University, Clinical Study Support Center, Wakayama, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': 'Wakayama Medical University, Clinical Study Support Center, Wakayama, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Dermatology, Wakayama Medical University, Wakayama, Japan.'}]",Lasers in surgery and medicine,['10.1002/lsm.23073']
786,30806078,"Effect of fine and gross motor training or motor imagery, delivered via novel or routine modes, on cognitive function.","There is extensive literature linking motor activity to cognitive effects at various stages in life, promoting both development and the reduction of aging associated pathologies. It is unclear whether the benefits of this activity on the cognitive level are associated with brain functions that are necessary for their performance or recurrence of activity or type of activity itself. The aim of this study was to evaluate whether the type of motor activity (fine, gross, and motor imagery) in two modes (novel and routine) can affect cognitive functions such as attention, executive functions, and praxis in college students. A 2 × 3 factorial design with repeated measures was used without a control group and pre- and post-training evaluation. Fifty-three young people (14 men and 39 women) participated, with mean age of 18.94 years ( SD  = 1.61 years) and were divided into six groups. Each of the groups performed relevant training 20 minutes per day for five days depending on the group. Measures were taken pre and post-training for attention tests, attention span, working memory, visual constructive skills, procedural memory, and motor skills. The results show a ""learning effect"" from the exposure to the tests in measurements after training. It was also found that between groups, there is a difference in some of the variables of procedural memory (number of errors) and working memory. More extensive training could better reflect the effects of the training, and longitudinal evaluation could show the rate of change of functions. The main clinical implication could be the evaluation of training programs for recovery and motor training in cerebral plasticity having effect on the cognitive aspects.",2020,"Measures were taken pre and post-training for attention tests, attention span, working memory, visual constructive skills, procedural memory, and motor skills.","['college students', 'Fifty-three young people (14 men and 39 women) participated, with mean age of 18.94\u2009years (SD\u2009=\u20091.61\u2009years']","['fine and gross motor training or motor imagery, delivered via novel or routine modes']","['motor activity (fine, gross, and motor imagery', 'attention tests, attention span, working memory, visual constructive skills, procedural memory, and motor skills', 'procedural memory (number of errors) and working memory']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0561782', 'cui_str': 'Procedural memory (observable entity)'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",53.0,0.0307402,"Measures were taken pre and post-training for attention tests, attention span, working memory, visual constructive skills, procedural memory, and motor skills.","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Brandwayn', 'Affiliation': 'Universität Osnabrück, Osnabrück, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Restrepo', 'Affiliation': 'Universität Ulm, Ulm, Germany.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Marcela Martinez-Martinez', 'Affiliation': 'Pontificia Universidad Javeriana, Bogotá, Colombia.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Acevedo-Triana', 'Affiliation': 'Universidad Pedagógica y Tecnológica de Colombia, Tunja, Colombia.'}]",Applied neuropsychology. Adult,['10.1080/23279095.2019.1566133']
787,30366759,Feasibility and Clinical Efficacy of a Multidisciplinary Home-Telehealth Program to Prevent Falls in Older Adults: A Randomized Controlled Trial.,"OBJECTIVES


The aim of this study was to determine the feasibility and efficacy of a 6-month tele-rehabilitation home-based program, designed to prevent falls in older adults with 1 or more chronic diseases (cardiac, respiratory, neuromuscular or neurologic) returning home after in-hospital rehabilitation for their chronic condition. Patients were eligible for selection if they had experienced a fall during the previous year or were at high risk of falling.
DESIGN


Randomized controlled trial. Tele-rehabilitation consisted of a falls prevention program run by the physiotherapist involving individual home exercise (strength, balance, and walking) and a weekly structured phone-call by the nurse inquiring about the disease status and symptoms and providing patient support.
SETTING AND PARTICIPANTS


Two hundred eighty-three patients (age 79 ± 6.6 years; F = 59%) with high risk of falls and discharged home after in-hospital rehabilitation were randomized to receive home-based program (intervention group, n = 141) or conventional care (control group, n = 142).
MEASURES


Incidence of falls at home in the 6-month period (primary outcome); time free to the first fall and proportion of patients sustaining ≥2 falls (secondary outcomes).
RESULTS


During the 6 months, 85 patients fell at least once: 29 (20.6%) in the Intervention Group versus 56 (39.4%) in the control group (P < .001). The risk of falls was significantly reduced in the intervention group (relative risk =0.60, 95% confidence interval: 0.44-0.83; P < .001). The mean ± standard deviation time to first fall was significantly longer in intervention group than control group (152 ± 58 vs 134 ± 62 days; P = .001). Significantly, fewer patients experienced ≥2 falls in the intervention group than in the control group: 11 (8%) versus 24 (17%), P = .020.
CONCLUSIONS


A 6-month tele-rehabilitation home-based program integrated with medical/nursing telesurveillance is feasible and effective in preventing falls in older chronic disease patients with a high risk of falling.",2019,"The risk of falls was significantly reduced in the intervention group (relative risk =0.60, 95% confidence interval: 0.44-0.83; P < .001).","['older chronic disease patients with a high risk of falling', 'Patients were eligible for selection if they had experienced a fall during the previous year or were at high risk of falling', 'older adults with 1 or more chronic diseases (cardiac, respiratory, neuromuscular or neurologic) returning home after in-hospital rehabilitation for their chronic condition', 'Older Adults', 'Two hundred eighty-three patients (age 79\xa0±\xa06.6\xa0years; F\xa0= 59%) with high risk of falls and discharged home after in-hospital rehabilitation']","['Multidisciplinary Home-Telehealth Program', '6-month tele-rehabilitation home-based program', 'falls prevention program run by the physiotherapist involving individual home exercise (strength, balance, and walking) and a weekly structured phone-call by the nurse inquiring about the disease status and symptoms and providing patient support', 'home-based program (intervention group, n\xa0=\xa0141) or conventional care (control group, n\xa0= 142']","['mean\xa0±\xa0standard deviation time to first fall', '≥2 falls', 'feasibility and efficacy', 'risk of falls']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0579192', 'cui_str': 'Returned home, life event (finding)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517823', 'cui_str': '6.6 (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",283.0,0.0645722,"The risk of falls was significantly reduced in the intervention group (relative risk =0.60, 95% confidence interval: 0.44-0.83; P < .001).","[{'ForeName': 'Palmira', 'Initials': 'P', 'LastName': 'Bernocchi', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, a Care Continuity Unit and Telemedicine Service, Institute of Lumezzane, Brescia, Italy. Electronic address: palmira.bernocchi@icsmaugeri.it.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Giordano', 'Affiliation': 'Cardiology Department of the Institute of Lumezzane, Brescia, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pintavalle', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, a Care Continuity Unit and Telemedicine Service, Institute of Lumezzane, Brescia, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Galli', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, a Care Continuity Unit and Telemedicine Service, Institute of Lumezzane, Brescia, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Ballini Spoglia', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, a Care Continuity Unit and Telemedicine Service, Institute of Lumezzane, Brescia, Italy.'}, {'ForeName': 'Doriana', 'Initials': 'D', 'LastName': 'Baratti', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, a Care Continuity Unit and Telemedicine Service, Institute of Lumezzane, Brescia, Italy.'}, {'ForeName': 'Simonetta', 'Initials': 'S', 'LastName': 'Scalvini', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, a Care Continuity Unit and Telemedicine Service, Institute of Lumezzane, Brescia, Italy; Cardiology Department of the Institute of Lumezzane, Brescia, Italy.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2018.09.003']
788,30401610,"Effect of Monthly Vitamin D on Chronic Pain Among Community-Dwelling Seniors: A Randomized, Double-Blind Controlled Trial.","OBJECTIVE


With advancing age, the prevalence of vitamin D deficiency and musculoskeletal pain increases. However, published data on the effectiveness of vitamin D supplementation in reducing chronic pain are inconclusive. The purpose of this study was to test the effect of 3 different monthly doses of vitamin D on chronic pain in seniors 70 years and older with a prior fall event.
DESIGN


1-year, double-blind randomized clinical trial.
SETTING


The trial was conducted in Zurich, Switzerland. Participants were 200 community-dwelling men and women 70 years and older with a prior fall.
INTERVENTION


Three study groups with monthly treatments were randomized to either a low-dose control group of vitamin D (24,000 IU vitamin D 3 /mo), a high dose of vitamin D 3  (60,000 IU vitamin D 3 /mo), or a combination of calcifediol and vitamin D 3  (24,000 IU vitamin D 3  plus 300 μg calcifediol/mo).
MEASUREMENTS


The primary endpoint was the change in the mean number of painful areas using the McGill Pain map over 12 months of follow-up. All analyses were adjusted for age, sex, body mass index, 25-hydroxyvitamin (OH)D 3  levels, and pain scores at baseline. A predefined subgroup analysis was performed by baseline 25(OH)D status (<20 vs ≥ 20 ng/mL).
RESULTS


The mean age of the participants was 78 years, 67.0% (134 of 200) were female, and 58.0% (116 of 200) were vitamin D deficient (<20 ng/mL) at baseline. Over 12 months of follow-up, the changes in the mean number of painful areas did not differ significantly among treatment groups (P = .46). However, there was a significant interaction effect between baseline vitamin levels (<20 vs ≥ 20 ng/mL) and treatment (P = .02). Among those who were vitamin D replete at baseline (n = 84), there was a significant difference between treatment groups over time (P = .04), and only seniors in the 24,000-IU vitamin D 3  group had a marginally significant decrease in their total mean pain score (-0.77; 95% CI, -1.56 to 0.01, P = .05), whereas there were no changes in the high-dose groups. Among seniors who were vitamin D deficient at baseline (n = 116), chronic pain did not differ by treatment groups over time (P = .33).
CONCLUSION


Our results suggest that both starting level of 25(OH)D 3  and monthly treatment dose of vitamin D may be important with respect to chronic pain reduction-with the only benefit seen among vitamin D-replete seniors treated with a monthly dose of 24,000 IU vitamin D 3 .",2019,"Over 12 months of follow-up, the changes in the mean number of painful areas did not differ significantly among treatment groups (P = .46).","['Participants were 200 community-dwelling men and women 70\xa0years and older with a prior fall', 'seniors 70\xa0years and older with a prior fall event', 'The mean age of the participants was 78\xa0years, 67.0% (134 of 200) were female, and 58.0% (116 of 200) were', 'Community-Dwelling Seniors']","['vitamin D', 'vitamin D 3  (60,000 IU vitamin D 3 /mo), or a combination of calcifediol and vitamin D 3  (24,000 IU vitamin D 3  plus 300\xa0μg calcifediol/mo', 'vitamin D supplementation', 'low-dose control group of vitamin D', '25-hydroxyvitamin', 'Monthly Vitamin D', 'vitamin D deficient']","['OH)D 3  levels, and pain scores', 'Chronic Pain', 'baseline vitamin levels', 'total mean pain score', 'chronic pain', 'mean number of painful areas using the McGill Pain map', 'mean number of painful areas']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0428580', 'cui_str': 'Vitamin measurement'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0024779', 'cui_str': 'Map'}]",200.0,0.63929,"Over 12 months of follow-up, the changes in the mean number of painful areas did not differ significantly among treatment groups (P = .46).","[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Schlögl', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland; Centre on Aging and Mobility, University of Zurich, Switzerland.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Chocano-Bedoya', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland; Centre on Aging and Mobility, University of Zurich, Switzerland.'}, {'ForeName': 'Bess', 'Initials': 'B', 'LastName': 'Dawson-Hughes', 'Affiliation': 'USDA Human Nutrition Research Center on Aging, Tufts University, Boston, MA.'}, {'ForeName': 'Endel J', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': 'Department of Biostatistics, Harvard School of Public Health, Boston, MA.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Freystaetter', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland; Centre on Aging and Mobility, University of Zurich, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Theiler', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland; Centre on Aging and Mobility, University of Zurich, Switzerland.'}, {'ForeName': 'Reto W', 'Initials': 'RW', 'LastName': 'Kressig', 'Affiliation': 'Department of Geriatrics, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Egli', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland; Centre on Aging and Mobility, University of Zurich, Switzerland.'}, {'ForeName': 'Heike A', 'Initials': 'HA', 'LastName': 'Bischoff-Ferrari', 'Affiliation': 'Department of Geriatrics and Aging Research, University Hospital Zurich and University of Zurich, Switzerland; Centre on Aging and Mobility, University of Zurich, Switzerland; University Clinic for Acute Geriatrics Care, Waid City Hospital, Zurich, Switzerland. Electronic address: Heike.Bischoff@usz.ch.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2018.09.004']
789,30811630,"Randomized, double-blind, phase III clinical study of a novel nanotechnological topical anesthetic formulation containing lidocaine 25 mg/g and prilocaine 25 mg/g (nanorap) in skin phototypes I-III patients with ablative fractional CO 2  laser treatment indication in the forehead.","BACKGROUND AND OBJECTIVES


Nanotechnology may increase the speed of penetration into the skin. This study evaluated the efficacy, safety, and pharmacokinetics of a novel topical anesthetic nanocapsule formulation (2 g) containing 2.5% lidocaine and 2.5% prilocaine (nanorap-test formulation) compared to placebo (control formulation) in skin types I-III patients of both sexes submitted to the ablative fractional CO 2  laser treatment.
METHODS


The patients (n = 120) included in this double-blind, single-center, randomized trial, received topical application of 2 g of the test formulation (50 mg lidocaine + 50 mg prilocaine) and placebo on the forehead region. Efficacy was assessed as pain sensation in four quadrants of each side of the forehead using a visual analogue scale immediately (0 min) and at 30, 60, and 90 minutes after laser application compared to placebo. The safety and tolerability of the test product were evaluated based on the occurrence of systemic adverse events as well as the occurrence of immediate and late skin reactions. Pharmacokinetic evaluation was performed in plasma of eight patients using a validated LC-MS/MS method for drugs quantification.
RESULTS


Nanorap induced a clinically significant reduction in the pain assessment at all evaluated times (57.2%, 41.6%, 38.6%, and 37.3% at 0, 30, 60, and 90 minutes after drug application, respectively. Mean values of C max  were 14.20 and 5.36 ng/ml and t max  were 3.5 and 1.8 hour for lidocaine and prilocaine, respectively. No systemic adverse events were observed.
CONCLUSION


The nanorap formulation demonstrated a clinically and statistically significant efficacy providing analgesia after the ablative fractional CO 2  laser therapy in the investigated patients, when compared to placebo. The product also presented good safety and tolerability. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.",2019,"The nanorap formulation demonstrated a clinically and statistically significant efficacy providing analgesia after the ablative fractional CO 2  laser therapy in the investigated patients, when compared to placebo.","['skin types', '2019']","['lidocaine and 2.5% prilocaine (nanorap-test formulation', 'placebo', 'lidocaine', 'ablative fractional CO 2  laser treatment', 'prilocaine', 'lidocaine\u2009+\u200950\u2009mg prilocaine', 'placebo (control formulation']","['Efficacy', 'efficacy, safety, and pharmacokinetics', 'pain assessment', 'safety and tolerability', 'efficacy providing analgesia', 'occurrence of immediate and late skin reactions', 'systemic adverse events', 'pain sensation', 'Mean values of C max']","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0033124', 'cui_str': 'Prilocaine'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.0903429,"The nanorap formulation demonstrated a clinically and statistically significant efficacy providing analgesia after the ablative fractional CO 2  laser therapy in the investigated patients, when compared to placebo.","[{'ForeName': 'Cíntia', 'Initials': 'C', 'LastName': 'Gobbato', 'Affiliation': 'Department of Pharmacology, Faculty of Medical Sciences, State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Gobbato', 'Affiliation': 'Department of Pharmacology, Faculty of Medical Sciences, State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Tainah B', 'Initials': 'TB', 'LastName': 'Magalhães', 'Affiliation': 'Department of Pharmacology, Faculty of Medical Sciences, State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Mendes', 'Affiliation': 'Faculty of Medicine, São Leopoldo Mandic (SLMANDIC), Campinas, São Paulo, Brazil.'}, {'ForeName': 'Jaime O', 'Initials': 'JO', 'LastName': 'Ilha', 'Affiliation': 'Galeno Research Unit, Campinas, Brazil.'}, {'ForeName': 'Ronilson A', 'Initials': 'RA', 'LastName': 'Moreno', 'Affiliation': 'Department of Pharmacology, Faculty of Medical Sciences, State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Natalícia J', 'Initials': 'NJ', 'LastName': 'Antunes', 'Affiliation': 'Department of Pharmacology, Faculty of Medical Sciences, State University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'De Nucci', 'Affiliation': 'Department of Pharmacology, Faculty of Medical Sciences, State University of Campinas (UNICAMP), Campinas, Brazil.'}]",Lasers in surgery and medicine,['10.1002/lsm.23071']
790,30797045,"C-reactive protein, Epstein-Barr virus, and cortisol trajectories in refugee and non-refugee youth: Links with stress, mental health, and cognitive function during a randomized controlled trial.","Experiencing childhood adversity has been associated with significant changes in inflammation, cell-mediated immunocompetence, and cortisol secretion. Relatively few studies have examined, longitudinally, alterations to inflammatory processes during adolescence, especially outside Western contexts; none have evaluated biomarker trajectories for at-risk youth in response to a structured behavioral intervention. We conducted a randomized controlled trial evaluating the efficacy of a humanitarian intervention targeting stress-alleviation, with 12-18 year-old Syrian refugees (n = 446) and Jordanian non-refugees (n = 371) living side-by-side in war-affected communities in Jordan. We measured C-reactive protein (CRP), Epstein-Barr virus antibodies (EBV), and hair cortisol concentration (HCC) at three timepoints (pre/post intervention and 11 month follow-up), and assessed three main outcomes (psychosocial stress, mental health, and cognitive function). Using growth mixture models, regressions, and growth curve models, we identified three distinct trajectories for CRP, two for EBV, and three for HCC, and examined their associations with age, gender, BMI, poverty, and trauma. We found associations with BMI for CRP, refugee status for EBV, and BMI and gender with HCC trajectory. In terms of health outcomes, we found associations between rising CRP levels and perceived stress (B =  -2.92, p = .007), and between HCC hypersecretion and insecurity (B = 7.21, p = .017). In terms of responses to the intervention, we observed no differential impacts by CRP or EBV trajectories, unlike HCC. These results suggest that commonly-assayed biomarkers do not associate with health outcomes and respond to targeted interventions in straightforward ways. Our study is the first to examine multiple biomarker trajectories in war-affected adolescents, in order to better evaluate the extent, timing, and malleability of the biological signatures of poverty, conflict, and forced displacement.",2020,"Experiencing childhood adversity has been associated with significant changes in inflammation, cell-mediated immunocompetence, and cortisol secretion.",['12-18\u202fyear-old Syrian refugees (n\u202f=\u202f446) and Jordanian non-refugees (n\u202f=\u202f371) living side-by-side in war-affected communities in Jordan'],['humanitarian intervention'],"['main outcomes (psychosocial stress, mental health, and cognitive function', 'C-reactive protein, Epstein-Barr virus, and cortisol trajectories', 'C-reactive protein (CRP), Epstein-Barr virus antibodies (EBV), and hair cortisol concentration (HCC', 'rising CRP levels and perceived stress', 'HCC hypersecretion and insecurity']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0337819', 'cui_str': 'Syrians (ethnic group)'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}]",[],"[{'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0014644', 'cui_str': 'Epstein-Barr Virus'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0236525', 'cui_str': 'Epstein-Barr virus antibody (substance)'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0233497', 'cui_str': 'Insecurity (finding)'}]",,0.0231915,"Experiencing childhood adversity has been associated with significant changes in inflammation, cell-mediated immunocompetence, and cortisol secretion.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Panter-Brick', 'Affiliation': 'Department of Anthropology, Yale University, New Haven, USA. Electronic address: catherine.panter-brick@yale.edu.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Wiley', 'Affiliation': 'Department of Anthropology, Yale University, New Haven, USA.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Sancilio', 'Affiliation': 'Department of Anthropology, Yale University, New Haven, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Dajani', 'Affiliation': 'Department of Biology and Biotechnology, Hashemite University, Zarqa, Jordan.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Hadfield', 'Affiliation': 'Department of Biological and Experimental Psychology, Queen Mary University of London, UK.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.02.015']
791,30680830,Synergy of pulmonary vein isolation and catheter renal denervation in atrial fibrillation complicated with uncontrolled hypertension: Mapping the renal sympathetic nerve and pulmonary vein (the pulmonary vein isolation plus renal denervation strategy)?,"INTRODUCTION


Disturbance of sympathetic and vagal nervous system participates in the pathogenesis of hypertension and atrial fibrillation (AF). Renal denervation (RDN) can modulate autonomic nervous activity and reduce blood pressure (BP) in hypertensive patients. We aimed to evaluate the effect of RDN combined with pulmonary vein isolation (PVI) in patients with AF and hypertension.
METHODS


Clinical trials including randomized data comparing PVI plus RDN vs PVI alone were enrolled. Primary outcome was incidence of AF recurrence after procedure.
RESULTS


A total of 387 patients, of them 252 were randomized and were enrolled. Mean age was 57 ± 10 years, 71% were male, and mean left ventricular ejection fraction was 57.4% ± 6.9%. Follow-up for randomized data was 12 months. Overall comparison for primary outcome showed that PVI + RDN was associated with significantly lower AF recurrence as compared with PVI alone (35.8% vs 55.4%, P < 0.0001). This advantageous effect was consistently maintained among randomized patients (37.3% vs 61.9%, odds ratio = 0.37, P = 0.0001), and among patients with implanted devices for detection of AF recurrence (38.9% vs 61.6%, P = 0.007). Post-hoc sensitivity and regression analysis demonstrated very good stability of this primary result. Pooled Kaplan-Meier analysis further showed that PVI + RDN was associated with significantly higher freedom from AF recurrence as compared with PVI alone (log-rank test, P = 0.001). Besides, RDN resulted in significant BP reduction without additionally increasing the risk of adverse events.
CONCLUSIONS


RDN may provide synergetic effects with PVI to reduce the burden of AF and improve BP control in patients with AF and uncontrolled hypertension.",2019,"Pooled Kaplan-Meier analysis further showed that PVI + RDN was associated with significantly higher freedom from AF recurrence as compared with PVI alone (log-rank test, P = 0.001).","['Mean age was 57\u2009±\u200910 years, 71% were male, and mean left ventricular ejection fraction was 57.4%\u2009±\u20096.9', 'hypertensive patients', 'A total of 387 patients, of them 252 were randomized and were enrolled', 'patients with AF and hypertension', 'atrial fibrillation complicated with uncontrolled hypertension', 'patients with AF and uncontrolled hypertension']","['pulmonary vein isolation and catheter renal denervation', 'PVI plus RDN vs PVI alone', 'RDN combined with pulmonary vein isolation (PVI', 'Renal denervation (RDN']","['burden of AF and improve BP control', 'risk of adverse events', 'BP reduction', 'AF recurrence', 'PVI\u2009+\u2009RDN', 'blood pressure (BP', 'incidence of AF recurrence after procedure']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0231242', 'cui_str': 'Complicated (qualifier value)'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}]","[{'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0580203', 'cui_str': 'Postprocedural period (qualifier value)'}]",387.0,0.129155,"Pooled Kaplan-Meier analysis further showed that PVI + RDN was associated with significantly higher freedom from AF recurrence as compared with PVI alone (log-rank test, P = 0.001).","[{'ForeName': 'Shaojie', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Cardioangiologisches Centrum Bethanien (CCB) Frankfurt am Main, Frankfurt Academy For Arrhythmias (FAFA), Medizinische Klinik III, Agaplesion Markus Krankenhaus, Frankfurt, Germany.'}, {'ForeName': 'Marcio G', 'Initials': 'MG', 'LastName': 'Kiuchi', 'Affiliation': 'School of Medicine-Royal Perth Hospital Unit, University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Yuehui', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Department of Cardiology, Chongqing Cardiac Arrhythmia Service Center, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Shaowen', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Shanghai First People's Hospital/Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Schratter', 'Affiliation': 'Medizinische Abteilung mit Kardiologie, Krankenhaus Hietzing Wien, Vienna, Austria.'}, {'ForeName': 'Willem-Jan', 'Initials': 'WJ', 'LastName': 'Acou', 'Affiliation': 'Department of Cardiology, AZ Delta, Roeselare, Belgium.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Meyer', 'Affiliation': 'Klinik für Kardiologie mit Schwerpunkt Elektrophysiologie, Universitäres Herzzentrum Hamburg, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Pürerfellner', 'Affiliation': 'Abteilung der kardialen Elektrophysiologie/Kardiologie, Akademisches Lehrkrankenhaus der Elisabethinen, Ordensklinikum Linz Elisabethinen, Linz, Austria.'}, {'ForeName': 'K R Julian', 'Initials': 'KRJ', 'LastName': 'Chun', 'Affiliation': 'Cardioangiologisches Centrum Bethanien (CCB) Frankfurt am Main, Frankfurt Academy For Arrhythmias (FAFA), Medizinische Klinik III, Agaplesion Markus Krankenhaus, Frankfurt, Germany.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Schmidt', 'Affiliation': 'Cardioangiologisches Centrum Bethanien (CCB) Frankfurt am Main, Frankfurt Academy For Arrhythmias (FAFA), Medizinische Klinik III, Agaplesion Markus Krankenhaus, Frankfurt, Germany.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.13858']
792,30777645,Impact of a multi-component immunization intervention on pneumococcal and herpes zoster vaccinations: A randomized controlled trial of community pharmacies in 2 states.,"BACKGROUND


The purpose of this study was to assess the impact of the We Immunize Program on structures, processes, and outcomes of pneumococcal and herpes zoster pharmacy-based immunization services.
METHODS


Pharmacy-technician pairs from 62 Alabama and California community pharmacies participated in a 6-month randomized controlled trial (intervention = 30/control = 32). All received immunization update training; intervention participants also received practical strategies training and monthly telephonic expert feedback. Completion of immunization service structure and process activities were analyzed using Fisher's Exact and one-way Mann-Whitney U tests. The primary outcome, change in number of pneumococcal, herpes zoster, and total vaccine doses administered, was assessed using one-way Wilcoxon signed rank and Mann-Whitney U tests. Associations between program and vaccine doses across time were explored using generalized estimating equations (GEE).
RESULTS


Intervention pharmacies completed more structure (median 12.00 versus 9.00, p = 0.200) and process activities (median 8.00 versus 7.00, p = 0.048) compared to control. Statistically significant increases in the median number of pneumococcal vaccine doses (7.50-12.00 doses, p = 0.007), and total vaccine doses (12.50-28.00 doses, p = 0.014) were seen from baseline to post-intervention within the intervention group. However, these changes were not statistically significant when compared to the control group (pneumococcal p = 0.136, total p = 0.202). Changes in median herpes zoster vaccine doses did not reach significance among intervention (8.50-9.00, p = 0.307) or control (9.00-13.00, p = 0.127) pharmacies.
CONCLUSIONS


Practical strategies training combined with tailored expert feedback enhanced existing pneumococcal immunization services in community pharmacies.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02615470.",2019,"RESULTS


Intervention pharmacies completed more structure (median 12.00 versus 9.00, p = 0.200) and process activities (median 8.00 versus 7.00, p = 0.048) compared to control.","['Pharmacy-technician pairs from 62 Alabama and California community pharmacies participated in a 6-month randomized controlled trial (intervention\u202f=\u202f30/control\u202f=\u202f32', 'community pharmacies in 2 states', 'pneumococcal and herpes zoster vaccinations']","['immunization update training; intervention participants also received practical strategies training and monthly telephonic expert feedback', 'multi-component immunization intervention']","['median herpes zoster vaccine doses', 'change in number of pneumococcal, herpes zoster, and total vaccine doses administered, was assessed using one-way Wilcoxon signed rank and Mann-Whitney U tests', 'total vaccine doses', 'median number of pneumococcal vaccine doses', 'process activities']","[{'cui': 'C0260119', 'cui_str': ""Pharmacists' Aides""}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0589105', 'cui_str': 'Strategy training (regime/therapy)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine (substance)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.0973209,"RESULTS


Intervention pharmacies completed more structure (median 12.00 versus 9.00, p = 0.200) and process activities (median 8.00 versus 7.00, p = 0.048) compared to control.","[{'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Hohmann', 'Affiliation': 'Auburn University Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, 020 James E. Foy Hall, Auburn, AL, 36849, USA. Electronic address: LAH0036@auburn.edu.'}, {'ForeName': 'Tessa J', 'Initials': 'TJ', 'LastName': 'Hastings', 'Affiliation': 'Auburn University Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, 020 James E. Foy Hall, Auburn, AL, 36849, USA. Electronic address: tjh0043@auburn.edu.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Ha', 'Affiliation': 'Keck Graduate Institute School of Pharmacy, 535 Watson Drive, Claremont, CA, 91711, USA. Electronic address: David_Ha@kgi.edu.'}, {'ForeName': 'Kimberly B', 'Initials': 'KB', 'LastName': 'Garza', 'Affiliation': 'Auburn University Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, 020 James E. Foy Hall, Auburn, AL, 36849, USA. Electronic address: kbl0005@auburn.edu.'}, {'ForeName': 'Sally A', 'Initials': 'SA', 'LastName': 'Huston', 'Affiliation': 'Keck Graduate Institute School of Pharmacy, 535 Watson Drive, Claremont, CA, 91711, USA. Electronic address: Sally_Huston@kgi.edu.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Auburn University Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, 020 James E. Foy Hall, Auburn, AL, 36849, USA. Electronic address: Lzc0061@auburn.edu.'}, {'ForeName': 'Salisa C', 'Initials': 'SC', 'LastName': 'Westrick', 'Affiliation': 'Auburn University Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, 020 James E. Foy Hall, Auburn, AL, 36849, USA. Electronic address: westrsc@auburn.edu.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2019.01.006']
793,31260642,"Promoting Breast Cancer Surveillance: The EMPOWER Study, a Randomized Clinical Trial in the Childhood Cancer Survivor Study.","PURPOSE


The aim of the current study was to increase the uptake of screening mammography among high-risk women who were treated for a childhood cancer with chest radiotherapy.
PATIENTS AND METHODS


Two hundred four female survivors in the Childhood Cancer Survivor Study who were treated with chest radiotherapy with 20 Gy or greater, age 25 to 50 years, and without breast imaging in the past 24 months were randomly assigned 2:1 to receive a mailed informational packet followed by a tailored telephone-delivered brief motivational interview (intervention) versus an attention control. Primary outcome was the difference in the proportion of participants who completed a screening mammogram by 12 months as evaluated in an intent-to-treat analysis. Stratum-adjusted relative risk (RR) and 95% CI were estimated using the Cochran-Mantel-Haenszel method. Secondary outcomes included the completion of screening breast magnetic resonance imaging (MRI) and barriers to screening and moderating factors.
RESULTS


Women in the intervention group were significantly more likely than those in the control group to report a mammogram (45 [33.1%] of 136  v  12 [17.6%] of 68; RR, 1.9; 95% CI, 1.1 to 3.3). The intervention was more successful among women age 25 to 39 years (RR, 2.2; 95% CI, 1.1 to 4.7) than among those age 40 to 50 years (RR, 1.4; 95% CI, 0.6 to 3.2). The proportion of women who reported a breast MRI at 12 months was similar between the two groups: 16.2% (intervention) compared with 13.2% (control; RR, 1.2; 95% CI, 0.6 to 2.5). Primary barriers to completing a screening mammogram and/or breast MRI included lack of physician recommendation, deferred action by survivor, cost, and absence of symptoms.
CONCLUSION


Use of mailed materials followed by telephone-delivered counseling increased mammography screening rates in survivors at high risk for breast cancer; however, this approach did not increase the rate of breast MRI. Cost of imaging and physician recommendation were important barriers that should be addressed in future studies.",2019,"The intervention was more successful among women age 25 to 39 years (RR, 2.2; 95% CI, 1.1 to 4.7) than among those age 40 to 50 years (RR, 1.4; 95% CI, 0.6 to 3.2).","['Two hundred four female survivors in the Childhood Cancer Survivor Study who were treated with chest radiotherapy with 20 Gy or greater, age 25 to 50 years, and without breast imaging in the past 24 months', 'Promoting Breast Cancer Surveillance', 'high-risk women who were treated for a childhood cancer with chest radiotherapy', 'survivors at high risk for breast cancer']","['telephone-delivered counseling', 'mailed informational packet followed by a tailored telephone-delivered brief motivational interview (intervention) versus an attention control']","['uptake of screening mammography', 'completion of screening breast magnetic resonance imaging (MRI) and barriers to screening and moderating factors', 'rate of breast MRI', 'lack of physician recommendation, deferred action by survivor, cost, and absence of symptoms', 'breast MRI', 'mammography screening rates']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4047809', 'cui_str': 'At high risk for breast cancer'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C1641805', 'cui_str': 'Packet'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0203028', 'cui_str': 'Screening mammography (procedure)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]",204.0,0.106373,"The intervention was more successful among women age 25 to 39 years (RR, 2.2; 95% CI, 1.1 to 4.7) than among those age 40 to 50 years (RR, 1.4; 95% CI, 0.6 to 3.2).","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Oeffinger', 'Affiliation': '1Duke University, Durham, NC.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Ford', 'Affiliation': '2Hunter College, City University of New York, New York, NY.'}, {'ForeName': 'Chaya S', 'Initials': 'CS', 'LastName': 'Moskowitz', 'Affiliation': '4Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Joanne F', 'Initials': 'JF', 'LastName': 'Chou', 'Affiliation': '4Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Tara O', 'Initials': 'TO', 'LastName': 'Henderson', 'Affiliation': '5The University of Chicago, Chicago, IL.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Hudson', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Diller', 'Affiliation': '7Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ford', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Nidha Z', 'Initials': 'NZ', 'LastName': 'Mubdi', 'Affiliation': '4Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Dayton', 'Initials': 'D', 'LastName': 'Rinehart', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Vukadinovich', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Gibson', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Anderson', 'Affiliation': '4Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Elena B', 'Initials': 'EB', 'LastName': 'Elkin', 'Affiliation': '4Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Garrett', 'Affiliation': '8University of Colorado School of Public Health, Denver, CO.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rebull', 'Affiliation': '9University of Vermont, Burlington, VT.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Leisenring', 'Affiliation': '10Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Leslie L', 'Initials': 'LL', 'LastName': 'Robison', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Armstrong', 'Affiliation': ""6St Jude Children's Research Hospital, Memphis, TN.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00547']
794,30773797,Efficacy of the SEPARPROCATH® radiation drape to reduce radiation exposure during cardiac catheterization: A pilot comparative study.,"BACKGROUND


Interventional cardiologists are exposed to radiation-induced diseases, partly due to patient's scatter radiation.
OBJECTIVES


We sought to compare the radiation exposure (RE) of the cardiac catheterization room staff using SEPARPROCATH®, a novel radio-protective drape versus standard shielding equipment.
METHODS


This was a two-step prospective, randomized pilot trial: first, in experimental conditions using a phantom model, and second, during cardiac catheterization. Primary end-point was operator RE corresponding to the ratio between operator cumulative dose (CD) and dose area product (DAP). Secondary end-points were nurse RE, operator and nurse CD, DAP, and fluoroscopy time.
RESULTS


A total of 51 patients were included. SEPARPROCATH® was associated with a lower operator RE (0.07 [0-0.19] vs. 0.37 [0.23-0.81] μSv/Gy.cm 2  without SEPARPROCATH®, p value <0.0001) and lower nurse RE (0 [0-0.05] vs. 0.13 [0.03-0.28] μSv/Gy.cm 2  , p value <0.0001) corresponding to an RE relative risk reduction of 81% and 99%, respectively. Similar reductions were observed for operator and nurse CDs. No difference was found in DAP (19 [11-29] vs. 14 [10-32] Gy.cm 2  without SEPARPROCATH®, p value 0.81).
CONCLUSION


SEPARPROCATH® offers significant additional radioprotection to the operator and nurse during cardiac catheterization without affecting patient safety.",2019,"SEPARPROCATH® was associated with a lower operator RE (0.07 [0-0.19] vs. 0.37 [0.23-0.81] μSv/Gy.cm 2  without SEPARPROCATH®, p value <0.0001) and lower nurse RE (0 [0-0.05] vs. 0.13 [0.03-0.28] μSv/Gy.cm 2  , p value <0.0001) corresponding to an RE relative risk reduction of 81% and 99%, respectively.","['cardiac catheterization', 'A total of 51 patients were included']","['SEPARPROCATH® radiation drape', 'SEPARPROCATH®']","['lower nurse RE', 'nurse RE, operator and nurse CD, DAP, and fluoroscopy time', 'operator RE corresponding to the ratio between operator cumulative dose (CD) and dose area product (DAP', 'DAP']","[{'cui': 'C0018795', 'cui_str': 'Catheterization, Heart'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0525921', 'cui_str': 'alpha,beta-diacryloxypropionic acid'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]",51.0,0.0353946,"SEPARPROCATH® was associated with a lower operator RE (0.07 [0-0.19] vs. 0.37 [0.23-0.81] μSv/Gy.cm 2  without SEPARPROCATH®, p value <0.0001) and lower nurse RE (0 [0-0.05] vs. 0.13 [0.03-0.28] μSv/Gy.cm 2  , p value <0.0001) corresponding to an RE relative risk reduction of 81% and 99%, respectively.","[{'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Patet', 'Affiliation': 'Department of Cardiology, University and Hospital of Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Ryckx', 'Affiliation': 'Department of Radiation Physics, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Arroyo', 'Affiliation': 'Department of Cardiology, University and Hospital of Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Department of Cardiology, University and Hospital of Fribourg, Fribourg, Switzerland.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Goy', 'Affiliation': 'Department of Cardiology, University and Hospital of Fribourg, Fribourg, Switzerland.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28130']
795,31697384,Efficacy of the AS04-Adjuvanted HPV16/18 Vaccine: Pooled Analysis of the Costa Rica Vaccine and PATRICIA Randomized Controlled Trials.,"BACKGROUND


The AS04-adjuvanted HPV16/18 (AS04-HPV16/18) vaccine provides excellent protection against targeted human papillomavirus (HPV) types and a variable degree of cross-protection against others, including types 6/11/31/33/45. High efficacy against any cervical intraepithelial neoplasia grade 3 or greater (CIN3+; >90%) suggests that lower levels of protection may exist for a wide range of oncogenic HPV types, which is difficult to quantify in individual trials. Pooling individual-level data from two randomized controlled trials, we aimed to evaluate AS04-HPV16/18 vaccine efficacy against incident HPV infections and cervical abnormalities .
METHODS


Data were available from the Costa Rica Vaccine Trial (NCT00128661) and Papilloma Trial Against Cancer in Young Adults trial (NCT00122681), two large-scale, double-blind randomized controlled trials of the AS04-HPV16/18 vaccine. Primary analyses focused on disease-free women with no detectable cervicovaginal HPV at baseline.
RESULTS


A total of 12 550 women were included in our primary analyses (HPV arm = 6271, control arm = 6279). Incidence of 6-month persistent oncogenic and nononcogenic infections, excluding known and accepted protected types 6/11/16/18/31/33/45 (focusing on 34/35/39/40/42/43/44/51/52/53/54/56/58/59/66/68/73/70/74), was statistically significantly lower in the HPV arm than in the control arm (efficacy = 9.9%, 95% confidence interval [CI] = 1.7% to 17.4%). Statistically significant efficacy (P < .05) was observed for individual oncogenic types 16/18/31/33/45/52 and nononcogenic types 6/11/53/74. Efficacy against cervical abnormalities (all types) increased with severity, ranging from 27.7% (95% CI = 21.7% to 33.3%) to 58.7% (95% CI = 34.1% to 74.7%) for cytologic outcomes (low-grade squamous intraepithelial neoplasia lesion or greater, and high-grade squamous intraepithelial neoplasia lesion or greater, respectively) and 66.0% (95% CI = 54.4% to 74.9%) to 87.8% (95% CI = 71.1% to 95.7%) for histologic outcomes (CIN2+ and CIN3+, respectively). Comparing Costa Rica Vaccine Trial and Papilloma Trial Against Cancer in Young Adults results, there was no evidence of heterogeneity, except for type 51 (efficacy = -28.6% and 20.7%, respectively; two-sided P = .03).
CONCLUSIONS


The AS04-HPV16/18 vaccine provides some additional cross-protection beyond established protected types, which partially explains the high efficacy against CIN3+.",2020,Statistically significant efficacy (p < 0.05) was observed for individual oncogenic types,"['12,550 women']","['AS04-adjuvanted HPV-16/18 vaccine', 'CVT', 'AS04-HPV-16/18 vaccine', 'AS04-adjuvanted HPV-16/18 (AS04-HPV-16/18) vaccine']","['high-grade squamous intraepithelial neoplasia lesion', 'disease-free women with no detectable cervicovaginal HPV', 'Incidence of six month persistent oncogenic/non-oncogenic infections', 'individual oncogenic types', 'Efficacy against cervical abnormalities']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0334245', 'cui_str': 'Squamous intraepithelial neoplasia, grade III (morphologic abnormality)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",,0.6415,Statistically significant efficacy (p < 0.05) was observed for individual oncogenic types,"[{'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Tota', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Struyf', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Sampson', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Gonzalez', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ryser', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Rolando', 'Initials': 'R', 'LastName': 'Herrero', 'Affiliation': 'Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Guanacaste, Costa Rica.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Schussler', 'Affiliation': 'Information Management Services, Rockville, MD.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Karkada', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Ana Cecilia', 'Initials': 'AC', 'LastName': 'Rodriguez', 'Affiliation': 'Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Folschweiller', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Porras', 'Affiliation': 'Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, San José, Costa Rica.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Schiffman', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Schiller', 'Affiliation': 'Center for Cancer Research, National Cancer Institute, Bethesda.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Quint', 'Affiliation': 'DDL Diagnostic Laboratory, Rijswijk, the Netherlands.'}, {'ForeName': 'Aimée R', 'Initials': 'AR', 'LastName': 'Kreimer', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD.'}, {'ForeName': 'Cosette M', 'Initials': 'CM', 'LastName': 'Wheeler', 'Affiliation': 'Department of Pathology and Obstetrics and Gynecology, University of New Mexico Cancer Center, Albuquerque, NM.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hildesheim', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the National Cancer Institute,['10.1093/jnci/djz222']
796,30676219,Optimization of the Effects of Physical Activity on Plantar Sensation and Postural Control With Barefoot Exercises in Institutionalized Older Adults: A Pilot Study.,"Increasing somatosensory information from the foot by exercising barefoot can potentially optimize the effectiveness of physical exercise interventions on falls prevention in the older adults. This pilot study was then undertaken to explore the effects of increased somatosensory information from the foot by exercising barefoot on balance, gait, and plantar cutaneous sensitivity in institutionalized older adults involved in multimodal exercise intervention. Participants were assigned to three groups: a control group which did not perform any physical exercise and two groups in which they were involved in a multimodal exercise program performed barefoot or shod. Postural, gait, and plantar cutaneous sensitivity parameters were collected. The results showed that the exercise program produced larger effects on balance and plantar cutaneous sensitivity when exercises were performed barefoot, without any noticeable effect on gait. Hence, barefoot exercising could be a relevant means to optimize the fall-prevention exercise programs in institutionalized older adults.",2019,"The results showed that the exercise program produced larger effects on balance and plantar cutaneous sensitivity when exercises were performed barefoot, without any noticeable effect on gait.","['Institutionalized Older Adults', 'institutionalized older adults', 'older adults']","['exercising barefoot', 'Physical Activity', 'control group which did not perform any physical exercise and two groups in which they were involved in a multimodal exercise program performed barefoot or shod', 'physical exercise interventions', 'multimodal exercise intervention', 'Plantar Sensation and Postural Control With Barefoot Exercises']","['Postural, gait, and plantar cutaneous sensitivity parameters', 'balance and plantar cutaneous sensitivity', 'balance, gait, and plantar cutaneous sensitivity']","[{'cui': 'C0562359', 'cui_str': 'Institutionalized (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0277844', 'cui_str': 'Barefoot walking (finding)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0127166,"The results showed that the exercise program produced larger effects on balance and plantar cutaneous sensitivity when exercises were performed barefoot, without any noticeable effect on gait.","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Korchi', 'Affiliation': ''}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Noé', 'Affiliation': ''}, {'ForeName': 'Noëlle', 'Initials': 'N', 'LastName': 'Bru', 'Affiliation': ''}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Paillard', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2018-0016']
797,30793920,Low Dose Fluoroscopy During Ureteroscopy Does Not Compromise Surgical Outcomes.,"Objective:  To evaluate whether reducing the dose of fluoroscopy to ¼ of standard dose during unilateral ureteroscopy for ureteral stone treatment would impact in a reduction of total radiation emitted and whether this strategy would impact operation time, stone-free rate, and complication rate.  Methods:  From August 2016 to August 2017, patients over 18 years submitted to ureteroscopy for ureteral stone between 5 and 20 mm were prospectively randomized for ¼ dose reduction or standard dose fluoroscopy. Patients with abnormal urinary anatomy such as horseshoe kidney, pelvic kidney, or duplex system were excluded from the study.  Results:  Ninety-four patients were enrolled. The fluoroscopic dose reduction strategy to ¼ of the standard dose was able to significantly reduce the cumulative radiation emitted by C-arm fluoroscopy and the dose area product (3.6 ± 4.5 mGy  vs  16.2 ± 19.3 mGy,  p  = 0.0001 and 0.23 ± 0.52 mcGycm 2   vs  1.15 ± 2.74 mcGycm 2 ,  p  = 0.02, respectively). Fluoroscopy time was similar between groups (74.5 ± 84.8 seconds  vs  88.3 ± 90 seconds,  p  = 0.44). There was no need to increase the fluoroscopy dose during any of the procedures. Surgical outcomes were not affected by fluoroscopic dose reduction strategy.  Conclusion:  Low dose fluoroscopy reduces the emitted radiation during ureteroscopy without compromising surgical outcomes.",2019,"The fluoroscopic dose reduction strategy to ¼ of the standard dose was able to significantly reduce the cumulative radiation emitted by C-arm fluoroscopy and the dose area product (3.6±4.5 mGy vs.16.2±19.3 mGy, p=0.0001 and 0.23±0.52","['from August 2016 to August 2017', '94 patients were enrolled', 'Patients with abnormal urinary anatomy such as horseshoe kidney, pelvic kidney or duplex system were excluded from the study', ' patients over 18 years old submitted to ureteroscopy for ureteral stone between 5-20 mm']",['standard dose fluoroscopy'],"['operation time, stone free rate and complication rate', 'Fluoroscopy time', 'cumulative radiation emitted']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0221353', 'cui_str': 'Horseshoe Kidney'}, {'cui': 'C0221209', 'cui_str': 'Congenital pelvic kidney (disorder)'}, {'cui': 'C0444916', 'cui_str': 'Duplex (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C0041952', 'cui_str': 'Ureterolithiasis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}]","[{'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]",94.0,0.07633,"The fluoroscopic dose reduction strategy to ¼ of the standard dose was able to significantly reduce the cumulative radiation emitted by C-arm fluoroscopy and the dose area product (3.6±4.5 mGy vs.16.2±19.3 mGy, p=0.0001 and 0.23±0.52","[{'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Danilovic', 'Affiliation': '1 Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Nunes', 'Affiliation': '1 Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Lipkin', 'Affiliation': '2 Division of Urologic Surgery, Surgery Department, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Ferreira', 'Affiliation': '1 Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Fabio C M', 'Initials': 'FCM', 'LastName': 'Torricelli', 'Affiliation': '1 Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Giovanni S', 'Initials': 'GS', 'LastName': 'Marchini', 'Affiliation': '1 Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Srougi', 'Affiliation': '1 Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Nahas', 'Affiliation': '1 Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Mazzucchi', 'Affiliation': '1 Department of Urology, Hospital das Clinicas, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}]",Journal of endourology,['10.1089/end.2018.0722']
798,31699436,Postoperative pain control modalities for pectus excavatum repair: A prospective observational study of cryoablation compared to results of a randomized trial of epidural vs patient-controlled analgesia.,"BACKGROUND


Pain following bar placement for pectus excavatum is the dominant factor post-operatively and determines length of stay (LOS). We recently adopted intercostal cryoablation as our preferred method of pain control following minimally invasive pectus excavatum repair. We compared the outcomes of cryoablation to results of a recently concluded trial of epidural (EPI) and patient-controlled analgesia (PCA) protocols.
METHODS


We conducted a prospective observational study of patients undergoing bar placement for pectus excavatum using intercostal cryoablation. Results are reported and compared with those of a randomized trial comparing EPI with PCA. Comparisons of medians were performed using Kruskal-Wallis H tests with alpha 0.05.
RESULTS


Thirty-five patients were treated with cryoablation compared to 32 epidural and 33 PCA patients from the trial. Cryoablation was associated with longer operating time (101 min, versus 58 and 57 min for epidural and PCA groups, p < 0.01), resulted in less time to pain control with oral medication (21 h, versus 72 and 67 h, p < 0.01), and decreased LOS (1 day, versus 4.3 and 4.2 days, p < 0.01).
CONCLUSION


Intercostal cryoablation during minimally invasive pectus excavatum repair reduces LOS and perioperative opioid consumption compared with both EPI and PCA.
LEVEL OF EVIDENCE


II.",2020,"Cryoablation was associated with longer operating time (101 min, versus 58 and 57 min for epidural and PCA groups, p < 0.01), resulted in less time to pain control with oral medication (21 h, versus 72 and 67 h, p < 0.01), and decreased LOS (1 day, versus 4.3 and 4.2 days, p < 0.01).
","['Thirty-five patients were treated with cryoablation compared to 32 epidural and 33 PCA patients from the trial', 'patients undergoing bar placement for pectus excavatum using intercostal cryoablation', 'pectus excavatum repair']","['epidural (EPI) and patient-controlled analgesia (PCA', 'Postoperative pain control modalities', 'Intercostal cryoablation', 'epidural vs patient-controlled analgesia']","['time to pain control with oral medication', 'LOS', 'LOS and perioperative opioid consumption', 'longer operating time']","[{'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0010408', 'cui_str': 'Cryoablation'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0016842', 'cui_str': 'Pectus Excavatum'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0010408', 'cui_str': 'Cryoablation'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",32.0,0.0936581,"Cryoablation was associated with longer operating time (101 min, versus 58 and 57 min for epidural and PCA groups, p < 0.01), resulted in less time to pain control with oral medication (21 h, versus 72 and 67 h, p < 0.01), and decreased LOS (1 day, versus 4.3 and 4.2 days, p < 0.01).
","[{'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Dekonenko', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Dorman', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Yara', 'Initials': 'Y', 'LastName': 'Duran', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Juang', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Aguayo', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Fraser', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Tolulope A', 'Initials': 'TA', 'LastName': 'Oyetunji', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Snyder', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Holcomb', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Millspaugh', 'Affiliation': ""Department of Anesthesiology, Children's Mercy Kansas City, Kansas City, MO.""}, {'ForeName': 'Shawn D', 'Initials': 'SD', 'LastName': 'St Peter', 'Affiliation': ""Department of Surgery, Children's Mercy Kansas City, Kansas City, MO. Electronic address: sspeter@cmh.edu.""}]",Journal of pediatric surgery,['10.1016/j.jpedsurg.2019.09.021']
799,30768388,Families Who Benefit and Families Who Do Not: Integrating Person- and Variable-Centered Analyses of Parenting Intervention Responses.,"OBJECTIVE


Families with disruptive child behavior are typically referred to services based on children's behavior alone, rather than on underlying mechanisms of disruptive behavior. Yet, the presence of the precise mechanisms targeted by services might be essential for intervention success. We integrated person- and variable-centered approaches to test whether families with combined disruptive child behavior and harsh/inconsistent parenting indeed benefit most from a behavioral parenting intervention in indicated prevention context, compared to families with disruptive child behavior but less harsh/inconsistent parenting, and families with less severe disruptive behavior.
METHOD


Families (N = 387) of children aged 4 to 8 years (disruptive behavior >75 th  percentile) participated in a randomized trial of the Incredible Years parenting intervention (Trial NTR3594, www.trialregister.nl). We identified different response trajectories and tested whether families with combined child and parenting difficulties had a higher probability of responding well, compared to families with only child difficulties or less severe difficulties.
RESULTS


Most intervention group families (82%) showed a nonresponse trajectory. A minority (18%) showed a response trajectory with strong reductions in disruptive behavior (Cohen's d =1.45). As expected, families with both child and parenting difficulties were most likely to respond: 20% more than families with only child difficulties, and 40% more than families with less severe difficulties.
CONCLUSION


Incredible Years, as an indicated prevention program, benefits mainly families in which the mechanisms targeted by the intervention (ie, harsh/inconsistent parenting) is actually present, rather than all families. Careful matching of children to services based on assessments of both child and parenting behavior seems critical for intervention success.
CLINICAL TRIAL REGISTRATION INFORMATION


ORCHIDS: Study on Children's Genetic Susceptibility to Their Environment; https://www.trialregister.nl; 3594.",2019,"We identified different response trajectories and tested whether families with combined child and parenting difficulties had a higher probability of responding well, compared to families with only child difficulties or less severe difficulties.
","['families with disruptive child behavior but less harsh/inconsistent parenting, and families with less severe disruptive behavior', ""Children's Genetic Susceptibility to Their Environment; www.trialregister.nl;\xa03594"", 'Families (N\xa0= 387) of children aged 4 to 8 years (disruptive behavior >75 th  percentile', 'Families Who Benefit and Families', 'Families with disruptive child behavior']",['behavioral parenting intervention'],"['nonresponse trajectory', 'disruptive behavior']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C0442809', 'cui_str': 'Inconsistent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0474416', 'cui_str': 'Disruptive Behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0314657', 'cui_str': 'Genetic Susceptibility'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}]",[],"[{'cui': 'C0474416', 'cui_str': 'Disruptive Behavior'}]",,0.0443762,"We identified different response trajectories and tested whether families with combined child and parenting difficulties had a higher probability of responding well, compared to families with only child difficulties or less severe difficulties.
","[{'ForeName': 'Jolien', 'Initials': 'J', 'LastName': 'van Aar', 'Affiliation': 'University of Amsterdam, The Netherlands. Electronic address: JolienvanAar@gmail.com.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Leijten', 'Affiliation': 'University of Amsterdam, The Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Orobio de Castro', 'Affiliation': 'Utrecht University, The Netherlands.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Weeland', 'Affiliation': 'University of Amsterdam, The Netherlands.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Matthys', 'Affiliation': 'Utrecht University, The Netherlands.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Chhangur', 'Affiliation': 'University of Amsterdam, The Netherlands; Radboud University Nijmegen, The Netherlands.'}, {'ForeName': 'Geertjan', 'Initials': 'G', 'LastName': 'Overbeek', 'Affiliation': 'University of Amsterdam, The Netherlands.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.02.004']
800,31899888,"The Effect of Combined Aerobic Exercise and Calorie Restriction on Mood, Cognition, and Motor Behavior in Overweight and Obese Women.","BACKGROUND


The benefits of weight loss programs on mood, cognitive, and motor behavior are largely limited to those of calorie restriction or exercise alone. Our aim was to investigate the effect of combined calorie restriction and aerobic exercise intervention on mood, brain activity, and cognitive and motor behavior in overweight and obese women.
METHODS


Participants aged 36-56 years were randomized to either a control or an experimental group (aerobic exercise + 12.5% energy intake reduction) for a 6-month period. Changes in brain-derived neurotrophic factor levels, mood, prefrontal cortex activity, cognitive and motor performance were assessed.
RESULTS


Confusion and depression increased in the control group (P < .05), whereas tension decreased in the experimental group (P < .05). Brain-derived neurotrophic factor level and learning of a speed-accuracy task remained unchanged. Although prefrontal cortex activity and executive functions were not affected, the reaction time of visual scanning and associative learning were improved in the experimental group (P < .05). An improvement in reaction time during the speed-accuracy task was observed (P < .05).
CONCLUSION


Combined calorie restriction and aerobic exercise intervention improved the psychosocial state, had little impact on cognition, and no effect on brain activity and learning of the speed-accuracy task.",2020,"RESULTS


Confusion and depression increased in the control group (P < .05), whereas tension decreased in the experimental group (P < .05).","['Overweight and Obese Women', 'overweight and obese women', 'Participants aged 36-56 years']","['control or an experimental group (aerobic exercise + 12.5% energy intake reduction', 'Combined calorie restriction and aerobic exercise intervention', 'Combined Aerobic Exercise and Calorie Restriction', 'combined calorie restriction and aerobic exercise intervention']","['reaction time of visual scanning and associative learning', 'Changes in brain-derived neurotrophic factor levels, mood, prefrontal cortex activity, cognitive and motor performance', 'reaction time', 'Mood, Cognition, and Motor Behavior', 'Confusion and depression', 'tension', 'brain activity and learning of the speed-accuracy task', 'mood, brain activity, and cognitive and motor behavior', 'prefrontal cortex activity and executive functions']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C0600082', 'cui_str': '% energy intake (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0009676', 'cui_str': 'Confusional State'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0233494', 'cui_str': 'Tension (finding)'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.0337271,"RESULTS


Confusion and depression increased in the control group (P < .05), whereas tension decreased in the experimental group (P < .05).","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Žlibinaitė', 'Affiliation': ''}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Solianik', 'Affiliation': ''}, {'ForeName': 'Daiva', 'Initials': 'D', 'LastName': 'Vizbaraitė', 'Affiliation': ''}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Mickevičienė', 'Affiliation': ''}, {'ForeName': 'Albertas', 'Initials': 'A', 'LastName': 'Skurvydas', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0373']
801,30784555,"Comparison of prasugrel and clopidogrel in patients with non-cardioembolic ischaemic stroke: a phase 3, randomised, non-inferiority trial (PRASTRO-I).","BACKGROUND


The effect of prasugrel in terms of the prevention of recurrence of ischaemic stroke is unknown. We investigated the non-inferiority of prasugrel to clopidogrel for prevention of ischaemic stroke, myocardial infarction, and death from other vascular causes in Japanese patients with non-cardioembolic stroke.
METHODS


In this phase 3 randomised, double-blind, non-inferiority trial, patients aged 20-74 years who had had a non-cardioembolic stroke in the previous 1-26 weeks were recruited from 224 hospitals in Japan. Eligible patients were randomly assigned (1:1) to receive prasugrel (3·75 mg/day) or clopidogrel (75 mg/day) orally for 96-104 weeks. Randomisation was stratified according to stroke subtype. The randomisation schedule was generated by an independent statistician who created a computer-generated random number sequence. Patients, investigators, and the funder were masked to treatment allocation. The primary endpoint was combined incidence of ischaemic stroke (fatal and non-fatal), myocardial infarction (fatal and non-fatal), and death from other vascular causes in the intention-to-treat population. The safety endpoint was incidence of bleeding events, comprising life-threatening bleeding, major bleeding, and clinically relevant bleeding. The safety analysis was done in the population excluding trial patients with serious Good Clinical Practice violations, and those who had not taken the trial drug. The predefined non-inferiority margin was an upper 95% CI limit for the risk ratio (RR) of 1·35. The trial was registered with the Japan Pharmaceutical Information Center (JapicCTI-111582).
FINDINGS


Patients were recruited between Sept 1, 2011, and June 12, 2015. 3747 patients (797 [21%] women) were enrolled, with a mean age of 62·1 (SD 8·5) years. 3753 patients were randomly assigned to treatment and, of these patients, 1885 in the prasugrel group and 1862 in the clopidogrel group were confirmed to have taken the trial drug at least once, and six patients withdrew from the trial before administration of the trial drug. Thus, a total of 3747 patients were included in the full analysis set. 73 (4%) of 1885 patients in the prasugrel group and 69 (4%) of 1862 patients in the clopidogrel group reached the primary endpoint (RR 1·05, 95% CI 0·76-1·44). The incidence of bleeding events was not significantly different between treatment groups; life-threatening bleeding was observed in 18 (1%) patients in the prasugrel group and 23 (1%) patients in the clopidogrel group (RR 0·77, 0·41-1·42).
INTERPRETATION


The non-inferiority of prasugrel to clopidogrel for the prevention of ischaemic stroke, myocardial infarction, and death from other vascular causes was not confirmed in Japanese patients with non-cardioembolic stroke. No safety concerns were identified.
FUNDING


Daiichi Sankyo.",2019,"The incidence of bleeding events was not significantly different between treatment groups; life-threatening bleeding was observed in 18 (1%) patients in the prasugrel group and 23 (1%) patients in the clopidogrel group (RR 0·77, 0·41-1·42).
","['patients aged 20-74 years who had had a non-cardioembolic stroke in the previous 1-26 weeks were recruited from 224 hospitals in Japan', 'Japanese patients with non-cardioembolic stroke', '3753 patients', 'patients with non-cardioembolic ischaemic stroke', 'population excluding trial patients with serious Good Clinical Practice violations, and those who had not taken the trial drug', 'Patients were recruited between Sept 1, 2011, and June 12, 2015', '3747 patients were included in the full analysis set', 'Eligible patients', '3747 patients (797 [21%] women) were enrolled, with a mean age of 62·1 (SD 8·5) years']","['prasugrel to clopidogrel', 'prasugrel', 'prasugrel and clopidogrel', 'clopidogrel']","['life-threatening bleeding', 'incidence of bleeding events', 'combined incidence of ischaemic stroke (fatal and non-fatal), myocardial infarction (fatal and non-fatal), and death from other vascular causes in the intention-to-treat population', 'bleeding events, comprising life-threatening bleeding, major bleeding, and clinically relevant bleeding', 'ischaemic stroke, myocardial infarction, and death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1531624', 'cui_str': 'Cardioembolic stroke'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",3747.0,0.475259,"The incidence of bleeding events was not significantly different between treatment groups; life-threatening bleeding was observed in 18 (1%) patients in the prasugrel group and 23 (1%) patients in the clopidogrel group (RR 0·77, 0·41-1·42).
","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ogawa', 'Affiliation': 'Department of Neurosurgery, Iwate Medical University, Iwate, Japan. Electronic address: aogawa@iwate-med.ac.jp.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Toyoda', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Kitagawa', 'Affiliation': ""Department of Neurology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Takanari', 'Initials': 'T', 'LastName': 'Kitazono', 'Affiliation': 'Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Nagao', 'Affiliation': 'Department of Neurology, Nippon Medical School Tama Nagayama Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yamagami', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Shinichiro', 'Initials': 'S', 'LastName': 'Uchiyama', 'Affiliation': 'International University of Health and Welfare, Center for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Center, Tokyo, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Tanahashi', 'Affiliation': 'Department of Neurology, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Neurology, Sakai City Medical Center, Osaka, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Minematsu', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Izumi', 'Initials': 'I', 'LastName': 'Nagata', 'Affiliation': 'Department of Neurosurgery, Kokura Memorial Hospital, Fukuoka, Japan.'}, {'ForeName': 'Masakatsu', 'Initials': 'M', 'LastName': 'Nishikawa', 'Affiliation': 'Clinical Research Support Center, Mie University Hospital, Mie, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Nanto', 'Affiliation': 'Nishinomiya Municipal Central Hospital, Hyogo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Daiichi Sankyo, Tokyo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ikeda', 'Affiliation': 'Waseda University Faculty of Science and Engineering, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(18)30449-6']
802,30777794,"Phase 3 study of subcutaneous bortezomib, thalidomide, and prednisolone consolidation after subcutaneous bortezomib-based induction and autologous stem cell transplantation in patients with previously untreated multiple myeloma: the VCAT study.","Efficacy and safety of bortezomib-based consolidation following ASCT were investigated in newly diagnosed multiple myeloma patients from Australia, Korea, and China. Patients received three cycles of bortezomib-cyclophosphamide-dexamethasone induction followed by high-dose therapy/ASCT, then were randomized (1:1) to consolidation with TP (thalidomide 100 mg/d for ≤12 months/until disease progression; prednisolone 50 mg on alternate days indefinitely/until disease progression;  n  = 100) or VTP (subcutaneous bortezomib 1.3 mg/m 2  every 2 weeks for 32 weeks, plus TP;  n  = 103). The hypothesized difference in CR + VGPR rate (after ≤12 months consolidation therapy) was not met. The rate of CR + VGPR was numerically higher with VTP versus TP; however, this was not statistically significant (85.7% versus 77.1%; rate difference 8.6%; 95% confidence interval -2.3%-19.5%;  p  = .122). Secondary efficacy outcomes were similar between treatment arms. Addition of bortezomib to TP consolidation was associated with limited additional toxicity but did not significantly improve efficacy versus TP.",2019,"The rate of CR + VGPR was numerically higher with VTP versus TP; however, this was not statistically significant (85.7% versus 77.1%; rate difference 8.6%; 95% confidence interval -2.3%-19.5%; p = .122).","['newly diagnosed multiple myeloma patients from Australia, Korea, and China', 'patients with previously untreated multiple myeloma']","['bortezomib-based consolidation following ASCT', 'TP (thalidomide 100\u2009mg/d for ≤12 months/until disease progression; prednisolone', 'subcutaneous bortezomib, thalidomide, and prednisolone consolidation after subcutaneous bortezomib-based induction and autologous stem cell transplantation', 'VTP (subcutaneous bortezomib 1.3\u2009mg/m 2  every 2 weeks for 32 weeks, plus TP', 'bortezomib', 'bortezomib-cyclophosphamide-dexamethasone induction followed by high-dose therapy/ASCT']","['rate of CR\u2009+\u2009VGPR', 'CR\u2009+\u2009VGPR rate', 'Efficacy and safety']","[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1594102', 'cui_str': 'Thalidomide 100 MG [Thalomid]'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0039736', 'cui_str': 'Thalidomide'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.14591,"The rate of CR + VGPR was numerically higher with VTP versus TP; however, this was not statistically significant (85.7% versus 77.1%; rate difference 8.6%; 95% confidence interval -2.3%-19.5%; p = .122).","[{'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Horvath', 'Affiliation': 'Department of Haematology, Royal Adelaide Hospital , Adelaide , Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Department of Clinical Haematology, Alfred Health-Monash University , Melbourne , Australia.'}, {'ForeName': 'Melita', 'Initials': 'M', 'LastName': 'Kenealy', 'Affiliation': 'Cabrini Health, Australia and Monash University , Melbourne , Australia.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Joshua', 'Affiliation': 'Department of Haematology, Royal Prince Alfred Hospital , Camperdown , Australia, and Sydney University, Sydney, Australia.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Campbell', 'Affiliation': 'Department of Haematology, Andrew Love Cancer Centre , Geelong , Australia.'}, {'ForeName': 'Je-Jung', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Department of Hematology-Oncology, Chonnam National University Hwasun Hospital , Hwasun , Republic of Korea.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Hematology, Shanghai Changzheng Hospital , Shanghai , China.'}, {'ForeName': 'Lugui', 'Initials': 'L', 'LastName': 'Qiu', 'Affiliation': 'Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College , Tianjin , China.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kalff', 'Affiliation': 'Department of Clinical Haematology, Alfred Health-Monash University , Melbourne , Australia.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Khong', 'Affiliation': 'Department of Clinical Haematology, Alfred Health-Monash University , Melbourne , Australia.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Londhe', 'Affiliation': 'Janssen Research & Development LLC , Titusville , NJ , USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Siggins', 'Affiliation': 'Janssen Cilag , Sydney , Australia.'}, {'ForeName': 'Maximiliano', 'Initials': 'M', 'LastName': 'van Kooten Losio', 'Affiliation': 'Janssen Cilag , Sydney , Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eisbacher', 'Affiliation': 'Janssen Cilag , Sydney , Australia.'}, {'ForeName': 'H Miles', 'Initials': 'HM', 'LastName': 'Prince', 'Affiliation': 'Cabrini Health, Australia and Monash University , Melbourne , Australia.'}]",Leukemia & lymphoma,['10.1080/10428194.2019.1579322']
803,31324357,Comparison of Acute Versus Subacute Coronary Angiography in Patients With NON-ST-Elevation Myocardial Infarction (from the NONSTEMI Trial).,"The optimal timing of coronary angiography (CAG) in high-risk patients with acute coronary syndrome without persisting ST-segment elevation (NST-ACS) remains undetermined. The NON-ST-Elevation Myocardial Infarction trial aimed to compare outcomes in NSTE-ACS patients randomized to acute CAG (STEMI-like approach) with patients randomized to medical therapy and subacute CAG. We randomized 496 patients with suspected NST-ACS based on symptoms and significant regional ST depressions and/or elevated point-of-care troponin T (POC-cTnT) (≥50 ng/l) to either acute CAG (<2 hours, n = 245) or subacute CAG (<72 hours, n = 251). The primary end point was a composite of all-cause death, reinfarction, and readmission with congestive heart failure within 1 year from randomization. A final acute coronary syndrome (ACS) diagnosis was assigned to 429 (86.5%) patients. The median time from randomization to revascularization was 1.3 hours in the acute CAG group versus 51.1 hours in the subacute CAG group (p <0.001). The composite end point occurred in 25 patients (10.2%) in the acute CAG group and 29 (11.6%) in the subacute CAG group, p = 0.62. The acute CAG group had a 1-year all-cause mortality of 5.7% compared with 5.6% in the subacute CAG group, p = 0.96. In conclusion, neither the composite end point of all-cause death, reinfarction, and readmission with congestive heart failure nor mortality differed between an acute and subacute CAG approach in NSTE-ACS patients. However, identification of NSTE-ACS patients in the prehospital phase and direct triage to an invasive center is feasible, safe and may facilitate early diagnosis and revascularization.",2019,The median time from randomization to revascularization was 1.3 hours in the acute CAG group versus 51.1 hours in the subacute CAG group (p <0.001).,"['Patients With NON-ST-Elevation Myocardial Infarction', 'high-risk patients with acute coronary syndrome without persisting ST-segment elevation (NST-ACS) remains undetermined', '496 patients with suspected NST-ACS based on symptoms and significant regional ST depressions and/or elevated point-of-care troponin T (POC-cTnT) (≥50 ng/l) to either acute CAG (<2 hours, n\u202f=\u202f245) or subacute CAG (<72 hours, n\u202f=\u202f251']","['coronary angiography (CAG', 'Acute Versus Subacute Coronary Angiography', 'acute CAG (STEMI-like approach']","['composite of all-cause death, reinfarction, and readmission with congestive heart failure', 'median time from randomization to revascularization', '1-year all-cause mortality', 'cause death, reinfarction, and readmission with congestive heart failure nor mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4255010', 'cui_str': 'Non-ST-Elevation Myocardial Infarction'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0205258', 'cui_str': 'Indeterminate (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0520887', 'cui_str': 'ST segment depression (finding)'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C4517661', 'cui_str': '245'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}]","[{'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",496.0,0.0590504,The median time from randomization to revascularization was 1.3 hours in the acute CAG group versus 51.1 hours in the subacute CAG group (p <0.001).,"[{'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark. Electronic address: martin.b.rasmussen@clin.au.dk.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Stengaard', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Jacob T', 'Initials': 'JT', 'LastName': 'Sørensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Ingunn S', 'Initials': 'IS', 'LastName': 'Riddervold', 'Affiliation': 'Prehospital Emergency Medical Services, Central Denmark Region, Denmark.'}, {'ForeName': 'Hanne M', 'Initials': 'HM', 'LastName': 'Søndergaard', 'Affiliation': 'Department of Cardiology, Regional Hospital Viborg, Viborg, Denmark.'}, {'ForeName': 'Troels', 'Initials': 'T', 'LastName': 'Niemann', 'Affiliation': 'Department of Cardiology, Regional Hospital Vest Jutland, Herning, Denmark.'}, {'ForeName': 'Karen Kaae', 'Initials': 'KK', 'LastName': 'Dodt', 'Affiliation': 'Department of Medicine, Regional Hospital Horsens, Horsens, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Frost', 'Affiliation': 'Department of Medicine, Regional Hospital Silkeborg, Silkeborg, Denmark.'}, {'ForeName': 'Tage', 'Initials': 'T', 'LastName': 'Jensen', 'Affiliation': 'Department of Medicine, Regional Hospital Randers, Randers, Denmark.'}, {'ForeName': 'Bent', 'Initials': 'B', 'LastName': 'Raungaard', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Troels M', 'Initials': 'TM', 'LastName': 'Hansen', 'Affiliation': 'Prehospital Emergency Medical Services, Central Denmark Region, Denmark.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Giebner', 'Affiliation': 'Falck Danmark A/S, Copenhagen, Denmark.'}, {'ForeName': 'Claus-Henrik', 'Initials': 'CH', 'LastName': 'Rasmussen', 'Affiliation': 'Responce A/S Denmark, Hedensted, Denmark.'}, {'ForeName': 'Hans Erik', 'Initials': 'HE', 'LastName': 'Bøtker', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Steen D', 'Initials': 'SD', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Evald H', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Terkelsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus N, Denmark.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.06.007']
804,31602699,"Bovine-derived xenograft in combination with autogenous bone chips versus xenograft alone for the augmentation of bony dehiscences around oral implants: A randomized, controlled, split-mouth clinical trial.","AIM


The aim of the study was to evaluate whether the use of a xenograft is not inferior to the use of xenograft and autogenous bone chips in treating dehiscences at implant placement.
MATERIALS AND METHODS


After implant placement, leaving a dehiscence, control sites were treated using a composite graft (autogenous bone chips and xenograft) and at the test sites 100% xenograft was used. Both sites were covered with a resorbable collagen membrane. Dehiscences were measured clinically at implant placement and at re-entry. CBCT was taken immediately after implant placement and after 4 months.
RESULTS


In total, 28 GBR procedures were performed in 14 patients. On average, the change in vertical defect height was 2.07 mm (46.7%-test group) and 2.28 mm (50.9%-control group) (p > .05). The horizontal defect width at the implant shoulder change on average 1.85 mm (40.5%-test group) and 1.75 mm (40.9%-control group) (p > .05). On average, a loss in augmentation thickness of 0.45 mm (68.9%-test group) and 0.64 mm (55.5% control group) between implant placement and augmentation and abutment surgery was obtained at the implant shoulder.
CONCLUSION


Both treatment modalities seem to work to a certain extent. At implant shoulder level, the augmentation thickness seems to be disappeared after the healing phase. (NCT03946020).",2020,The horizontal defect width at the implant shoulder change on average 1.85mm (40.5% - test group) and 1.75mm (40.9% - control group) (p>0.05).,[],"['xenograft and autogenous bone chips', 'Bovine derived xenograft in combination with autogenous bone chips versus xenograft alone', 'CBCT']","['vertical defect height', 'augmentation thickness', 'Dehiscences', 'horizontal defect width']",[],"[{'cui': 'C0522537', 'cui_str': 'Xenografts'}, {'cui': 'C0443145', 'cui_str': 'Autogenous (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1510451', 'cui_str': 'Fries'}, {'cui': 'C1265545', 'cui_str': 'Family Bovidae'}]","[{'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}]",,0.0735622,The horizontal defect width at the implant shoulder change on average 1.85mm (40.5% - test group) and 1.75mm (40.9% - control group) (p>0.05).,"[{'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Temmerman', 'Affiliation': 'Section of Periodontology, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Cortellini', 'Affiliation': 'Section of Periodontology, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Van Dessel', 'Affiliation': 'OMFS-Impath Research Group, Department of Oral & Maxillofacial Surgery, KU Leuven & UZ University Hospitals, Leuven, Belgium.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'De Greef', 'Affiliation': 'Section of Periodontology, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Reinhilde', 'Initials': 'R', 'LastName': 'Jacobs', 'Affiliation': 'OMFS-Impath Research Group, Department of Oral & Maxillofacial Surgery, KU Leuven & UZ University Hospitals, Leuven, Belgium.'}, {'ForeName': 'Rutger', 'Initials': 'R', 'LastName': 'Dhondt', 'Affiliation': 'Section of Periodontology, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Teughels', 'Affiliation': 'Section of Periodontology, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Quirynen', 'Affiliation': 'Section of Periodontology, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals, KU Leuven, Leuven, Belgium.'}]",Journal of clinical periodontology,['10.1111/jcpe.13209']
805,30681939,"Coagulation, Thrombogenesis, and Insulin Resistance Markers in Increased-Cardiovascular-Risk Subjects Consuming Improved-Fat Meat Products.","OBJECTIVES


Cardiovascular disease (CVD) risk is prevalent in high-meat-product consumers. The effect of consuming lipid-improved pâtés/frankfurters on plasma low-density lipoprotein (LDL)-cholesterol, thromboxane A 2  (as TXB 2 ), prostacyclin I 2  (as 6-keto-PGF 1α ), activated partial thromboplastin time, fibrinogen, antithrombin, and insulin-resistance/sensitivity markers in volunteers at high CVD risk was studied.
SUBJECTS/METHODS


Eighteen male volunteers enrolled in a blind crossover-controlled study consumed improved products during three 4-week periods: reduced fat (RF), n-3-enriched-RF (n-3RF), and normal fat (NF), separated by 4-week washouts.
RESULTS


Fibrinogen and 6-keto-PG1α decreased (p < 0.05) following the RF period; LDL-cholesterol, TXB 2 , and 6-keto-PGF 1α  decreased (p < 0.05) after the n-3RF-period, while LDL-cholesterol, fibrinogen, TXB 2 , insulin, and Homostatic Model Assessment-insulin resistance (HOMA-IR) increased (at least p < 0.05) and QUICKI (Quantitative Insulin Sensitivity Check Index) decreased (p < 0.05) during the NF period. The rates of changes of fibrinogen, TXB 2 , 6-keto-PGF 1α , and HOMA-IR differ between groups (repeated-measures test p < 0.05). Fibrinogen, insulin, and HOMA-IR differed significantly (p < 0.05) between RF and n-3RF period versus NF period, while that of TXB 2  and 6-keto-PGF 1α  differed between n-3RF and NF periods (p < 0.05).
CONCLUSIONS


The consumption of n-3RF meat products, followed by RF ones, partially reduced thrombogenesis, coagulation, and insulin-resistance markers. Thus, the inclusion of lipid-improved pâtés/frankfurters might be recommended into dietary strategies in at-CVD-risk volunteers.",2019,"Fibrinogen, insulin, and HOMA-IR differed significantly (p < 0.05) between RF and n-3RF period versus NF period, while that of TXB 2  and 6-keto-PGF 1α  differed between n-3RF and NF periods (p < 0.05).
","['Eighteen male volunteers', 'volunteers at high CVD risk was studied']","['reduced fat (RF), n-3-enriched-RF (n-3RF), and normal fat (NF), separated by 4-week washouts']","['Fibrinogen, insulin, and HOMA-IR', 'thrombogenesis, coagulation, and insulin-resistance markers', 'Fibrinogen and 6-keto-PG1α', 'rates of changes of fibrinogen, TXB 2 , 6-keto-PGF 1α , and HOMA-IR', 'Coagulation, Thrombogenesis, and Insulin Resistance Markers', 'LDL-cholesterol, fibrinogen, TXB 2 , insulin, and Homostatic Model Assessment-insulin resistance (HOMA-IR', 'plasma low-density lipoprotein (LDL)-cholesterol, thromboxane A 2  (as TXB 2 ), prostacyclin I 2  (as 6-keto-PGF 1α ), activated partial thromboplastin time, fibrinogen, antithrombin, and insulin-resistance/sensitivity markers', 'QUICKI (Quantitative Insulin Sensitivity Check Index', 'RF period; LDL-cholesterol, TXB 2 , and 6-keto-PGF 1α']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0033561', 'cui_str': 'PGF'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0040061', 'cui_str': 'Thromboxanes'}, {'cui': 'C0205911', 'cui_str': 'Prostaglandins I'}, {'cui': 'C0052460', 'cui_str': 'AS 6'}, {'cui': 'C0030605', 'cui_str': 'Activated Partial Thromboplastin Time'}, {'cui': 'C0003440', 'cui_str': 'Direct Thrombin Inhibitors'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",18.0,0.0322174,"Fibrinogen, insulin, and HOMA-IR differed significantly (p < 0.05) between RF and n-3RF period versus NF period, while that of TXB 2  and 6-keto-PGF 1α  differed between n-3RF and NF periods (p < 0.05).
","[{'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Celada', 'Affiliation': 'a Departamento de Nutrición y Ciencia de los Alimentos. Facultad de Farmacia , Universidad Complutense. Madrid, Spain e Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC) , Madrid , 28040 , Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Olmedilla-Alonso', 'Affiliation': 'b Instituto de Ciencia y Tecnología de los Alimentos y Nutrición (ICTAN), CSIC , Madrid , Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Delgado-Pando', 'Affiliation': 'b Instituto de Ciencia y Tecnología de los Alimentos y Nutrición (ICTAN), CSIC , Madrid , Spain.'}, {'ForeName': 'Rafaela', 'Initials': 'R', 'LastName': 'Raposo', 'Affiliation': 'c Departamento de Fisiología, Facultad de Farmacia , Universidad Complutense de Madrid , Madrid , Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Jiménez-Colmenero', 'Affiliation': 'b Instituto de Ciencia y Tecnología de los Alimentos y Nutrición (ICTAN), CSIC , Madrid , Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Garcimartín', 'Affiliation': 'd Departamento de Farmacología, Facultad de Farmacia , Universidad Complutense de Madrid, Spain e Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC) , Madrid , Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Sánchez-Muniz', 'Affiliation': 'a Departamento de Nutrición y Ciencia de los Alimentos. Facultad de Farmacia , Universidad Complutense. Madrid, Spain e Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC) , Madrid , 28040 , Spain.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2018.1513345']
806,32407786,Study To Reduce Infection Prior to Elective Cesarean Deliveries (STRIPES): a randomized clinical trial of chlorhexidine.,"BACKGROUND


Surgical site infections after cesarean delivery are a cause of maternal morbidity and are typically caused by skin microbial flora. Preadmission application of chlorhexidine gluconate using impregnated cloths may decrease surgical site infections by decreasing the abundance of microbial flora.
OBJECTIVE


To determine whether the application of chlorhexidine gluconate cloths the night before and the morning of scheduled cesarean delivery decreases the risk of surgical site infections by 6 weeks postoperatively compared with placebo.
STUDY DESIGN


In this single-center, double-blind, placebo-controlled trial, patients were randomized (1:1) to receive either Sage 2% chlorhexidine cloths or Sage Comfort Bath fragrance-free cloths (placebo) to apply to 6 skin sites on the body (neck, shoulders and chest, armpits, arm and hands, abdomen and groin, left leg and foot, right leg and foot, back and buttocks) the night before and after a shower the morning of scheduled cesarean delivery. Routine clinical and operative procedures were followed. The primary outcome was surgical site infections (superficial or deep incisional with or without organ space endometritis) by 6 weeks after cesarean delivery. The secondary outcomes were surgical site infections by 2 weeks and other wound-related complications by 2 and 6 weeks after cesarean delivery.
RESULTS


From April 2015 to August 2019, 1356 patients were enrolled: 682 were assigned to the chlorhexidine group and 674 to the placebo group. The groups were similar in demographic and medical characteristics. A total of 14 patients were lost to follow-up before cesarean delivery (10 in chlorhexidine and 4 in placebo) and 33 were lost to follow-up after cesarean delivery (10 in chlorhexidine and 23 in placebo). Among the remaining 1309 (97%), no difference was found in surgical site infections by 6 weeks between the 2 groups (2.6% in chlorhexidine vs 3.7% in placebo; P=.24). There were no differences in secondary outcomes at 2 or 6 weeks and no differences in primary outcome in a per-protocol analysis.
CONCLUSION


Preadmission use of chlorhexidine gluconate cloths compared with placebo does not reduce the risk of surgical site infection after scheduled cesarean deliveries. Following the standard of care guidelines results in a low risk of surgical site infections in this group of patients.",2020,Patients and physicians who follow the standard of care guidelines have a low risk of surgical site infections in this group of patients.,"['1,356 patients were enrolled: 682', 'From April 2015 through August 2019', 'Prior to Elective Cesarean Deliveries (STRIPES', 'Fourteen patients were lost to follow-up prior to cesarean delivery (10 in']","['chlorhexidine gluconate-impregnated cloths', 'chlorhexidine and 23 in placebo', 'chlorhexidine', 'Sage 2% chlorhexidine cloths or Sage Comfort Bath fragrance-free cloths (placebo', 'chlorhexidine gluconate', 'chlorhexidine and 4 in placebo', 'placebo']","['risk of surgical site infections', 'surgical site infection', 'surgical site infections (superficial or deep -incisional and/or organ space-endometritis', 'surgical site infections by 2 weeks and other wound-related complications', 'Infection', 'surgical site infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C1532935', 'cui_str': 'Striped'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122976', 'cui_str': 'Sage'}, {'cui': 'C0031000', 'cui_str': 'Perfume'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",1356.0,0.327365,Patients and physicians who follow the standard of care guidelines have a low risk of surgical site infections in this group of patients.,"[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: joanne.stone@mssm.edu.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Monro', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Overybey', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Cadet', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Katie Hyewon', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Pena', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Robles', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Mella', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Kathy C', 'Initials': 'KC', 'LastName': 'Matthews', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Stephanie H', 'Initials': 'SH', 'LastName': 'Factor', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.021']
807,32407919,Application of a Microsurgical Space Restrictor in Microsurgical Simulation Training.,"OBJECTIVE


To investigate the effect of the application of a microsurgical space restrictor in microsurgical simulation training.
METHODS


A microsurgical space restrictor that can restrict the operation space was designed and produced. Forty neurosurgery residents with standardized training were selected as the study subjects and were randomly divided into the experimental group (group A) and the control group (group B). Group A was trained using the space restrictor, and group B was trained using the traditional method. The skills and overall performance of the 2 groups of trainees were assessed by the Stanford Microsurgery and Resident Training (SMaRT) scale. The assessment was divided into 2 stages: the unobstructed microsurgery test, and the test with the microsurgical operation space restrictor.
RESULTS


In group A, the score for the first stage (A1) was 3.9 ± 0.6, the score for the second stage (A2) was 3.4 ± 0.6, and the score for A1 was better than that for A2 (P = 0.000); in group B, the score for the first stage (B1) was 3.57 ± 0.6, the score for the second stage (B2) was 3.0 ± 0.6, and the score for B1 was better than that for B2 (P = 0.000). Overall, the score for A1 was better than that for B1 (P = 0.046), and the score for A2 was better than that for B2 (P = 0.009).
CONCLUSIONS


Microsurgical space restrictor use can improve the effect of microsurgical simulation training and help trainees better master microsurgical operation skills.",2020,"Overall, the score for A1 was better than that for B1 (P = 0.046), and the score for A2 was better than that for B2 (P = 0.009).
",['Forty neurosurgery residents with standardized training were selected as the study subjects'],"['microsurgical simulation training', 'Microsurgical Space Restrictor']",['Stanford Microsurgery and Resident Training (SMaRT) scale'],"[{'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]","[{'cui': 'C0026035', 'cui_str': 'Microsurgery'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",40.0,0.0137644,"Overall, the score for A1 was better than that for B1 (P = 0.046), and the score for A2 was better than that for B2 (P = 0.009).
","[{'ForeName': 'Zuowei', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China; Department of Neurosurgery, Education Department, Beijing Hospital, National Center of Gerontology, Beijing, People's Republic of China.""}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Education Department, Beijing Hospital, National Center of Gerontology, Beijing, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Kong', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Zan', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Xingwen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Fengzeng', 'Initials': 'F', 'LastName': 'Jian', 'Affiliation': ""Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Neurospine Center, China International Neuroscience Institute, Beijing, People's Republic of China. Electronic address: jianfengzeng@xwh.ccmu.edu.cn.""}]",World neurosurgery,['10.1016/j.wneu.2020.05.031']
808,31688064,"Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study.","OBJECTIVES


To assess the efficacy and safety of vonoprazan on heartburn symptoms in patients with nonerosive reflux disease (NERD) (ClinicalTrials.gov: NCT02954848).
METHODS


This phase 3, double-blind, placebo-controlled study included Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn. Patients received placebo (n = 245) or vonoprazan 10 mg (n = 238) for 4 weeks. The primary efficacy outcome was frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn). Other outcomes included cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution in the fourth week of treatment, and safety.
RESULTS


Compared with placebo, the proportion of days without heartburn was not significantly higher in the vonoprazan group in the full analysis (primary end point, 72.55% vs 61.50%, vonoprazan vs placebo, P = 0.0643) but was significantly higher in the per-protocol-set sensitivity analysis (P = 0.0341). Early onset of response and significantly greater cumulative improvement rates of heartburn were observed in the vonoprazan group (P = 0.0003). In a post hoc analysis, a greater proportion of patients with complete heartburn resolution in the fourth week of treatment were reported in the vonoprazan group (P = 0.0023). Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
DISCUSSION


Although vonoprazan 10 mg was not superior to placebo with respect to proportion of days without heartburn in Japanese patients with NERD, vonoprazan had a significantly higher cumulative rate of heartburn resolution and was well tolerated.",2019,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","['Patients With Nonerosive Gastroesophageal Reflux Disease', 'Japanese patients with NERD', 'patients with nonerosive reflux disease (NERD', 'Japanese patients aged 20 years and older with grade N/M NERD and recurrent heartburn']","['placebo', 'Placebo', 'Vonoprazan', 'vonoprazan']","['cumulative improvement rates of heartburn, proportion of patients with complete heartburn resolution', 'safety', 'tolerated', 'cumulative rate of heartburn resolution', 'Incidence of treatment-emergent adverse events', 'efficacy and safety', 'complete heartburn resolution', 'heartburn symptoms', 'cumulative improvement rates of heartburn', 'proportion of days without heartburn', 'Efficacy and Safety', 'frequency of heartburn experienced by patients during the treatment period (proportion of days without heartburn']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0017168', 'cui_str': 'Gastric Acid Reflux Disease'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018834', 'cui_str': 'Pyrosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4080009', 'cui_str': 'Vonoprazan'}]","[{'cui': 'C0018834', 'cui_str': 'Pyrosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.488409,"Incidence of treatment-emergent adverse events was similar between treatment groups (23.5% vs 23.3%); most treatment-emergent adverse events were mild in severity.
","[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Shimane University School of Medicine, Izumo, Japan.'}, {'ForeName': 'Yuuichi', 'Initials': 'Y', 'LastName': 'Sakurai', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Nobuyoshi', 'Initials': 'N', 'LastName': 'Takabayashi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kudou', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Araki', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Miyagi', 'Affiliation': 'Department of Internal Medicine, Fukuyama Daiichi Hospital, Hiroshima, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Iwakiri', 'Affiliation': 'Department of Gastroenterology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Ashida', 'Affiliation': 'Department of Gastroenterology, Rakuwakai Otowa Hospital, Kyoto, Japan.'}]",Clinical and translational gastroenterology,['10.14309/ctg.0000000000000101']
809,30692052,Long-term effect of thymectomy plus prednisone versus prednisone alone in patients with non-thymomatous myasthenia gravis: 2-year extension of the MGTX randomised trial.,"BACKGROUND


The Thymectomy Trial in Non-Thymomatous Myasthenia Gravis Patients Receiving Prednisone (MGTX) showed that thymectomy combined with prednisone was superior to prednisone alone in improving clinical status as measured by the Quantitative Myasthenia Gravis (QMG) score in patients with generalised non-thymomatous myasthenia gravis at 3 years. We investigated the long-term effects of thymectomy up to 5 years on clinical status, medication requirements, and adverse events.
METHODS


We did a rater-blinded 2-year extension study at 36 centres in 15 countries for all patients who completed the randomised controlled MGTX and were willing to participate. MGTX patients were aged 18 to 65 years at enrolment, had generalised non-thymomatous myasthenia gravis of less than 5 years' duration, had acetylcholine receptor antibody titres of 1·00 nmol/L or higher (or concentrations of 0·50-0·99 nmol/L if diagnosis was confirmed by positive edrophonium or abnormal repetitive nerve stimulation, or abnormal single fibre electromyography), had Myasthenia Gravis Foundation of America Clinical Classification Class II-IV disease, and were on optimal anticholinesterase therapy with or without oral corticosteroids. In MGTX, patients were randomly assigned (1:1) to either thymectomy plus prednisone or prednisone alone. All patients in both groups received oral prednisone at doses titrated up to 100 mg on alternate days until they achieved minimal manifestation status. The primary endpoints of the extension phase were the time-weighted means of the QMG score and alternate-day prednisone dose from month 0 to month 60. Analyses were by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00294658. It is closed to new participants, with follow-up completed.
FINDINGS


Of the 111 patients who completed the 3-year MGTX, 68 (61%) entered the extension study between Sept 1, 2009, and Aug 26, 2015 (33 in the prednisone alone group and 35 in the prednisone plus thymectomy group). 50 (74%) patients completed the 60-month assessment, 24 in the prednisone alone group and 26 in the prednisone plus thymectomy group. At 5 years, patients in the thymectomy plus prednisone group had significantly lower time-weighted mean QMG scores (5·47 [SD 3·87] vs 9·34 [5·08]; p=0·0007) and mean alternate-day prednisone doses (24 mg [SD 21] vs 48 mg [29]; p=0·0002) than did those in the prednisone alone group. 14 (42%) of 33 patients in the prednisone group, and 12 (34%) of 35 in the thymectomy plus prednisone group, had at least one adverse event by month 60. No treatment-related deaths were reported during the extension phase.
INTERPRETATION


At 5 years, thymectomy plus prednisone continues to confer benefits in patients with generalised non-thymomatous myasthenia gravis compared with prednisone alone. Although caution is appropriate when generalising our findings because of the small sample size of our study, they nevertheless provide further support for the benefits of thymectomy in patients with generalised non-thymomatous myasthenia gravis.
FUNDING


National Institutes of Health, National Institute of Neurological Disorders and Stroke.",2019,"At 5 years, patients in the thymectomy plus prednisone group had significantly lower time-weighted mean QMG scores (5·47 [SD 3·87]","['patients with generalised non-thymomatous myasthenia gravis at 3 years', '36 centres in 15 countries for all patients who completed the randomised controlled MGTX and were willing to participate', 'patients with non-thymomatous myasthenia gravis', 'patients with generalised non-thymomatous myasthenia gravis', ""MGTX patients were aged 18 to 65 years at enrolment, had generalised non-thymomatous myasthenia gravis of less than 5 years' duration, had acetylcholine receptor antibody titres of 1·00 nmol/L or higher (or concentrations of 0·50-0·99 nmol/L if diagnosis was confirmed by positive edrophonium or abnormal repetitive nerve stimulation, or abnormal single fibre electromyography), had Myasthenia Gravis Foundation of America Clinical Classification Class II-IV disease"", 'Non-Thymomatous Myasthenia Gravis Patients Receiving', '111 patients who completed the 3-year MGTX, 68 (61%) entered the extension study between Sept 1, 2009, and Aug 26, 2015 (33 in the prednisone alone group and 35 in the prednisone plus thymectomy group', '50 (74%) patients completed the 60-month assessment, 24 in the prednisone alone group and 26 in the prednisone plus thymectomy group']","['anticholinesterase therapy with or without oral corticosteroids', 'thymectomy', 'Prednisone (MGTX', 'thymectomy plus prednisone', 'prednisone alone', 'thymectomy combined with prednisone', 'thymectomy plus prednisone or prednisone alone', 'prednisone', 'oral prednisone']","['time-weighted means of the QMG score', 'time-weighted mean QMG scores', 'Quantitative Myasthenia Gravis (QMG) score', 'clinical status, medication requirements, and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0174725', 'cui_str': 'MGTX'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody (substance)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0439282', 'cui_str': 'nM'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0013615', 'cui_str': 'Edrophonium'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0430810', 'cui_str': 'Repetitive nerve stimulation (procedure)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0947912'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0002454', 'cui_str': 'Americas'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2945605', 'cui_str': 'Total thymectomy (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C3540712', 'cui_str': 'Anticholinesterases'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C2945605', 'cui_str': 'Total thymectomy (procedure)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0174725', 'cui_str': 'MGTX'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia Gravis'}, {'cui': 'C0449440', 'cui_str': 'Clinical status (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.191306,"At 5 years, patients in the thymectomy plus prednisone group had significantly lower time-weighted mean QMG scores (5·47 [SD 3·87]","[{'ForeName': 'Gil I', 'Initials': 'GI', 'LastName': 'Wolfe', 'Affiliation': 'Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA. Electronic address: gilwolfe@buffalo.edu.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Kaminski', 'Affiliation': 'Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC, USA.'}, {'ForeName': 'Inmaculada B', 'Initials': 'IB', 'LastName': 'Aban', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Minisman', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Hui-Chien', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Marx', 'Affiliation': 'Institute of Pathology, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Ströbel', 'Affiliation': 'Institute of Pathology, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Mazia', 'Affiliation': 'Department of Neurology, University of Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Oger', 'Affiliation': 'Division of Neurology, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'J Gabriel', 'Initials': 'JG', 'LastName': 'Cea', 'Affiliation': 'Department of Neurology, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jeannine M', 'Initials': 'JM', 'LastName': 'Heckmann', 'Affiliation': 'Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Evoli', 'Affiliation': 'Department of Neurology, Catholic University, Rome, Italy.'}, {'ForeName': 'Wilfred', 'Initials': 'W', 'LastName': 'Nix', 'Affiliation': 'Department of Neurology, Johanes Gutenberg University, Mainz, Germany.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Ciafaloni', 'Affiliation': 'Department of Neurology, University of Rochester Medical Centre, Rochester, NY, USA.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Antonini', 'Affiliation': 'Department of Neurology, Mental Health and Sensory Organs, University of Rome Sapienza, Rome, Italy.'}, {'ForeName': 'Rawiphan', 'Initials': 'R', 'LastName': 'Witoonpanich', 'Affiliation': 'Department of Neurology, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'John O', 'Initials': 'JO', 'LastName': 'King', 'Affiliation': 'Department of Neurology, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Said R', 'Initials': 'SR', 'LastName': 'Beydoun', 'Affiliation': 'Department of Neurology, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Colin H', 'Initials': 'CH', 'LastName': 'Chalk', 'Affiliation': 'Department of Neurology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Alexandru C', 'Initials': 'AC', 'LastName': 'Barboi', 'Affiliation': 'Department of Neurology, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Amato', 'Affiliation': 'Department of Neurology, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Aziz I', 'Initials': 'AI', 'LastName': 'Shaibani', 'Affiliation': 'Nerve and Muscle Centre of Texas, Houston, TX, USA.'}, {'ForeName': 'Bashar', 'Initials': 'B', 'LastName': 'Katirji', 'Affiliation': 'Department of Neurology, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Bryan R F', 'Initials': 'BRF', 'LastName': 'Lecky', 'Affiliation': 'Walton Centre for Neurology and Neurosurgery, Liverpool, UK.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Buckley', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Vincent', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Elza', 'Initials': 'E', 'LastName': 'Dias-Tosta', 'Affiliation': 'Unit of Neurology, Hospital de Base do Distrito Federal, Brasília, Brazil.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Neurology, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Márcia', 'Initials': 'M', 'LastName': 'Waddington-Cruz', 'Affiliation': 'Department of Neurology, Federal University, Rio de Janeiro, Brazil.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Pulley', 'Affiliation': 'Department of Neurology, University of Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Rivner', 'Affiliation': 'Department of Neurology, Georgia Regents University, Augusta, GA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kostera-Pruszczyk', 'Affiliation': 'Department of Neurology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Pascuzzi', 'Affiliation': 'Department of Neurology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': 'Department of Neurology, University of Texas Health Science Centre, San Antonio, TX, USA.'}, {'ForeName': 'Jan J G M', 'Initials': 'JJGM', 'LastName': 'Verschuuren', 'Affiliation': 'Department of Neurology, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Massey', 'Affiliation': 'Department of Neurology, Duke University Medical Centre, Durham, NC, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Kissel', 'Affiliation': 'Department of Neurology, Ohio State University Wexner Medical Centre, Columbus, OH, USA.'}, {'ForeName': 'Lineu C', 'Initials': 'LC', 'LastName': 'Werneck', 'Affiliation': 'Department of Neurology, Universidade Federal do Parana, Curitiba, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Benatar', 'Affiliation': 'Department of Neurology, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Barohn', 'Affiliation': 'Department of Neurology, University of Kansas Medical Centre, Kansas City, KS, USA.'}, {'ForeName': 'Rup', 'Initials': 'R', 'LastName': 'Tandan', 'Affiliation': 'Department of Neurological Sciences, University of Vermont College of Medicine, Burlington, VT, USA.'}, {'ForeName': 'Tahseen', 'Initials': 'T', 'LastName': 'Mozaffar', 'Affiliation': 'Department of Neurology, University of California, Irvine, Orange, CA, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Silvestri', 'Affiliation': 'Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Conwit', 'Affiliation': 'Division of Extramural Research, National Institutes of Health/National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Sonett', 'Affiliation': 'Section of General Thoracic Surgery, Columbia University Medical Centre, New York, NY, USA.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Jaretzki', 'Affiliation': 'Section of General Thoracic Surgery, Columbia University Medical Centre, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Newsom-Davis', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(18)30392-2']
810,30682573,Fixed-Dose Subcutaneous C1-Inhibitor Liquid for Prophylactic Treatment of C1-INH-HAE: SAHARA Randomized Study.,"BACKGROUND


Hereditary angioedema (HAE) with C1 inhibitor deficiency (C1-INH) is characterized by swelling of subcutaneous and/or submucosal tissues.
OBJECTIVE


To evaluate efficacy/safety of fixed-dose subcutaneous plasma-derived C1-INH (pdC1-INH) liquid for HAE attack prevention (NCT02584959).
METHODS


Eligible patients were ≥12 years with ≥2 monthly attacks prescreening or pre-long-term prophylaxis. In a partial crossover design, 80% of patients were randomized to placebo or pdC1-INH liquid for 14 weeks and crossed over from active to placebo or vice versa for another 14 weeks. The remainder were randomized to pdC1-INH liquid for 28 weeks. The primary efficacy endpoint was normalized number of attacks (NNA) versus placebo. Key additional endpoints were the proportion of patients achieving NNA reduction ≥50%, attack severity, number of attack-free days, and safety.
RESULTS


Seventy-five patients were randomized and 58 (77%) completed the study. Mean age 41 years; 88% HAE type I. Least-squares means of NNA were reduced from 3.9 with placebo to 1.6 with pdC1-INH (from day 1; P < .0001). Most patients had ≥50% NNA reduction with pdC1-INH (from day 1, 78%). A total of 8.8% of placebo-treated patients were attack-free and 5.3%, 22.8%, and 63.2% had mild, moderate, and severe attacks, respectively; 37.5% of pdC1-INH-treated patients were attack-free and 8.9%, 26.8%, and 26.8% had mild, moderate, and severe attacks, respectively. Treatment-emergent adverse event rates were similar between groups (52% vs 56% for pdC1-INH crossover vs placebo, respectively).
CONCLUSIONS


Fixed-dose subcutaneous pdC1-INH liquid was superior to placebo in preventing HAE attacks and demonstrated a favorable safety profile.",2019,"Treatment-emergent adverse event rates were similar between groups (52% vs 56% for pdC1-INH crossover vs placebo, respectively).
","['Seventy-five patients were randomized and 58 (77%) completed the study', 'Eligible patients were ≥12 years with ≥2 monthly attacks prescreening or pre-long-term prophylaxis']","['placebo', 'fixed-dose subcutaneous plasma-derived C1-INH (pdC1-INH) liquid', 'placebo or pdC1-INH liquid', 'pdC1-INH', 'pdC1-INH liquid']","['Treatment-emergent adverse event rates', 'proportion of patients achieving NNA reduction ≥50%, attack severity, number of attack-free days, and safety', 'HAE attacks', 'normalized number of attacks (NNA', 'attack-free']","[{'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0540301', 'cui_str': 'C1-INH'}, {'cui': 'C0208681', 'cui_str': 'factor XIIa inhibitor'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",75.0,0.376803,"Treatment-emergent adverse event rates were similar between groups (52% vs 56% for pdC1-INH crossover vs placebo, respectively).
","[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Lumry', 'Affiliation': 'AARA Research Center, Dallas, Texas. Electronic address: LumryMD@AllergySpecialists.us.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Martinez-Saguer', 'Affiliation': 'Hämophilie-Zentrum Rhein Main (HZRM), Mörfelden-Walldorf, Germany.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Yang', 'Affiliation': 'Ottawa Allergy Research Corporation, University of Ottawa Medical School, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Bernstein Clinical Research Center, Cincinnati, Ohio.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Jacobs', 'Affiliation': 'Allergy and Asthma Clinical Research, Walnut Creek, Calif.'}, {'ForeName': 'Dumitru', 'Initials': 'D', 'LastName': 'Moldovan', 'Affiliation': 'MediQuest Medical Center, Sangeorgiu de Mures, Târgu Mureș, Romania.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Riedl', 'Affiliation': 'University of California, San Diego, Calif.'}, {'ForeName': 'Douglas T', 'Initials': 'DT', 'LastName': 'Johnston', 'Affiliation': 'Asthma & Allergy Specialists, PA, Charlotte, NC.'}, {'ForeName': 'H Henry', 'Initials': 'HH', 'LastName': 'Li', 'Affiliation': 'Institute for Asthma and Allergy, Chevy Chase, Md.'}, {'ForeName': 'Yongqiang', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Shire, now part of Takeda, Lexington, Mass.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Schranz', 'Affiliation': 'Shire, now part of Takeda, Lexington, Mass.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': 'Shire, now part of Takeda, Lexington, Mass.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Vardi', 'Affiliation': 'Shire, now part of Takeda, Lexington, Mass.'}, {'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Farkas', 'Affiliation': 'Hungarian Angioedema Reference Center, Semmelweis University, Budapest, Hungary.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.01.021']
811,31675635,The effects of observing different gestures during storytelling on the recall of path and event information in 5-year-olds and adults.,"This study examined (a) how observing different types of gestures while listening to a story affected the recall of path and event information in 5-year-old children (n = 71) and adults (n = 55) and (b) whether the effects of gesture type on children's recall of information were related to individual differences such as working memory, language abilities, spontaneous gesture use, and gesture production during the recall task. Participants were asked four questions to measure their spontaneous gesture frequency. They then listened to a story that included different path and event information. Depending on the assigned condition, participants listened to the story with the narrator producing iconic gestures (gestures having semantic meaning), beat gestures (rhythmic hand movements), or no gesture. We then asked participants to relate what happened in the story and administered a recognition task about the story. Children were given standardized tests to assess their language and working memory skills. Children and adults best recalled the story after observing iconic gestures as compared with children and adults presented with beat gestures or no gestures. Children who were exposed to iconic gestures during encoding better recalled event information than children in the other conditions. Children's language abilities, but not working memory, were related to their recall performance. More important, children with better expressive language abilities benefitted more from seeing iconic gestures. These results suggest that observing iconic gestures at encoding facilitates recall and that children's language skills could play a role in encoding and using specific information provided by gestures.",2020,Children who were exposed to iconic gestures during encoding better recalled event information than children in the other conditions.,"['5-year-olds and adults', '5-year-old children (n\u202f=\u202f71) and adults (n\u202f=\u202f55) and (b']","['participants listened to the story with the narrator producing iconic gestures (gestures having semantic meaning), beat gestures (rhythmic hand movements), or no gesture']","['spontaneous gesture frequency', ""Children's language abilities"", 'working memory, language abilities, spontaneous gesture use, and gesture production during the recall task']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0008081', 'cui_str': 'Child Language'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0033268'}]",,0.049158,Children who were exposed to iconic gestures during encoding better recalled event information than children in the other conditions.,"[{'ForeName': 'Hazal', 'Initials': 'H', 'LastName': 'Kartalkanat', 'Affiliation': 'Department of Psychology, Koç University, Sariyer, 34450 Istanbul, Turkey.'}, {'ForeName': 'Tilbe', 'Initials': 'T', 'LastName': 'Göksun', 'Affiliation': 'Department of Psychology, Koç University, Sariyer, 34450 Istanbul, Turkey. Electronic address: tgoksun@ku.edu.tr.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.104725']
812,30883284,Screening and brief intervention with adolescents with risky alcohol use in school-based health centers: A randomized clinical trial of the  Check Yourself  tool.,"Background:  This study aimed to compare care delivery and alcohol and marijuana use for adolescents with risky alcohol use who received a school-based health center (SBHC) visit with and without the  Check Yourself  tool, an electronic tool that gives motivational feedback on substance use and summarizes results for providers.  Methods:  We conducted a randomized controlled trial with 148 adolescents aged 13-18 who met criteria for moderate- to high- risk alcohol use, recruited from urban SBHCs. Participants were randomized to receive their SBHC visit with ( n  = 73) or without ( n  = 75) the  Check Yourself  screening and feedback tool. All SBHC providers received a brief training on motivational interviewing.  Results:  Adolescents who received the  Check Yourself  tool + SBHC visit reported higher levels of alcohol (67%) and marijuana (73%) counseling from the provider during their visit, compared with those who received a SBHC visit without the tool (40% and 45%, respectively,  P s < .005), and had higher motivation to decrease marijuana use relative to those who did not ( P  = .02). Relative to baseline, adolescents in both groups reduced their typical number of drinks of alcohol, maximum number of drinks of alcohol, and hours high on marijuana over time ( P s < .02) at 2-month follow-up.  Conclusion:  When adolescent patients are given an electronic screening and feedback tool, it can prompt providers to increase counseling of adolescents with substance use risk. Overall, participants who had a visit with a trained provider reported high satisfaction with care and decreased the amount of alcohol use over 2 months, suggesting that SBHCs are an excellent venue for delivery of brief substance use interventions.",2019,"Relative to baseline, adolescents in both groups reduced their typical number of drinks of alcohol, maximum number of drinks of alcohol, and hours high on marijuana over time (Ps < .02) at 2-month follow-up.
","['adolescent patients', 'adolescents with risky alcohol use who received a', 'adolescents with risky alcohol use in school-based health centers', '148 adolescents aged 13-18 who met criteria for moderate- to high- risk alcohol use, recruited from urban SBHCs']","['SBHC visit with (n\u2009=\u200973) or without (n\u2009=\u200975) the Check Yourself screening and feedback tool', 'brief training on motivational interviewing', 'school-based health center (SBHC) visit with and without the Check Yourself tool, an electronic tool that gives motivational feedback']","['typical number of drinks of alcohol, maximum number of drinks of alcohol, and hours high on marijuana over time', 'levels of alcohol']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",148.0,0.0542876,"Relative to baseline, adolescents in both groups reduced their typical number of drinks of alcohol, maximum number of drinks of alcohol, and hours high on marijuana over time (Ps < .02) at 2-month follow-up.
","[{'ForeName': 'Carolyn A', 'Initials': 'CA', 'LastName': 'McCarty', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Elon', 'Initials': 'E', 'LastName': 'Gersh', 'Affiliation': 'Orygen, the National Centre of Excellence in Youth Mental Health, Department of Research and Translation, Melbourne, Australia.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Katzman', 'Affiliation': ""Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Gina S', 'Initials': 'GS', 'LastName': 'Sucato', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington, USA.'}, {'ForeName': 'Laura P', 'Initials': 'LP', 'LastName': 'Richardson', 'Affiliation': 'Department of Pediatrics, University of Washington, Seattle, Washington, USA.'}]",Substance abuse,['10.1080/08897077.2019.1576090']
813,30878794,Cash on delivery: Results of a randomized experiment to promote maternal health care in Kenya.,"We conducted a randomized controlled experiment to test whether vouchers, cash transfers, and SMS messages were effective in boosting facility delivery rates among poor, pregnant women in rural Kenya. We find a strong effect of the full vouchers and the conditional cash transfers: 48% of women with access to both interventions delivered in a health facility, while only 36% of those with neither did. Amongst women who did not receive a cash transfer, we find that a small copayment dramatically reduced voucher effectiveness, suggesting a discontinuous impact of cost-sharing on the demand for health services. Both the unconditional cash transfer and the text messages had limited effect on the use of health services. Finally, we also find no evidence that a government policy to eliminate user fees increased demand for maternal health services.",2019,"Amongst women who did not receive a cash transfer, we find that a small copayment dramatically reduced voucher effectiveness, suggesting a discontinuous impact of cost-sharing on the demand for health services.","['maternal health care in Kenya', 'pregnant women in rural Kenya']","['vouchers, cash transfers, and SMS messages']",[],"[{'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer'}]",[],,0.0697569,"Amongst women who did not receive a cash transfer, we find that a small copayment dramatically reduced voucher effectiveness, suggesting a discontinuous impact of cost-sharing on the demand for health services.","[{'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Grépin', 'Affiliation': 'Department of Health Sciences, Wilfrid Laurier University, Waterloo, ON, Canada. Electronic address: kgrepin@wlu.ca.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Habyarimana', 'Affiliation': 'McCourt School of Public Policy, Georgetown University, Washington DC, USA. Electronic address: jph35@georgetown.edu.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Jack', 'Affiliation': 'Department of Economics, Georgetown University, Washington DC, USA. Electronic address: wgj@georgetown.edu.'}]",Journal of health economics,['10.1016/j.jhealeco.2018.12.001']
814,30351167,Sex-related response to bivalirudin and unfractionated heparin in patients with acute myocardial infarction undergoing percutaneous coronary intervention: A subgroup analysis of the VALIDATE-SWEDEHEART trial.,"AIMS


Our aim was to study the impact of sex on anticoagulant treatment outcomes during percutaneous coronary intervention in acute myocardial infarction patients.
METHODS


This study was a prespecified analysis of the Bivalirudin versus Heparin in ST-Segment and Non ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated according to Recommended Therapies Registry Trial (VALIDATE-SWEDEHEART) trial, in which patients with myocardial infarction were randomised to bivalirudin or unfractionated heparin during percutaneous coronary intervention. The primary outcome was the composite of death, myocardial infarction or major bleeding at 180 days.
RESULTS


There was a lower risk of the primary outcome in women assigned to bivalirudin than to unfractionated heparin (13.6% vs 17.1%, hazard ratio 0.78, 95% confidence interval (0.60-1.00)) with no significant difference in men (11.8% vs 11.2%, hazard ratio 1.06 (0.89-1.26),  p  for interaction 0.05). The observed difference was primarily due to lower risk of major bleeding (Bleeding Academic Research Consortium definition 2, 3 or 5) associated with bivalirudin in women (8.9% vs 11.8%, hazard ratio 0.74 (0.54-1.01)) but not in men (8.5% vs 7.3%, hazard ratio 1.16 (0.94-1.43) in men,  p  for interaction 0.02). Conversely, no significant difference in the risk of Bleeding Academic Research Consortium 3 or 5 bleeding, associated with bivalirudin, was found in women 4.5% vs 5.4% (hazard ratio 0.84 (0.54-1.31)) or men 2.9% vs 2.1% (hazard ratio 1.36 (0.93-1.99)). Bleeding Academic Research Consortium 2 bleeding occurred significantly less often in women assigned to bivalirudin than to unfractionated heparin. The risk of death or myocardial infarction did not significantly differ between randomised treatments in men or women.
CONCLUSION


In women, bivalirudin was associated with a lower risk of adverse outcomes, compared to unfractionated heparin, primarily due to a significant reduction in Bleeding Academic Research Consortium 2 bleeds.",2019,"There was a lower risk of the primary outcome in women assigned to bivalirudin than to unfractionated heparin (13.6% vs 17.1%, hazard ratio 0.78, 95% confidence interval (0.60-1.00)) with no significant difference in men (11.8% vs 11.2%, hazard ratio 1.06 (0.89-1.26), p for interaction 0.05).","['men or women', 'patients with acute myocardial infarction undergoing percutaneous coronary intervention', 'acute myocardial infarction patients', 'patients with myocardial infarction']","['bivalirudin and unfractionated heparin', 'percutaneous coronary intervention', 'Bivalirudin versus Heparin', 'unfractionated heparin', 'bivalirudin', 'bivalirudin or unfractionated heparin']","['risk of Bleeding Academic Research Consortium 3 or 5 bleeding', 'composite of death, myocardial infarction or major bleeding at 180 days', 'risk of death or myocardial infarction']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}]","[{'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035168'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.23806,"There was a lower risk of the primary outcome in women assigned to bivalirudin than to unfractionated heparin (13.6% vs 17.1%, hazard ratio 0.78, 95% confidence interval (0.60-1.00)) with no significant difference in men (11.8% vs 11.2%, hazard ratio 1.06 (0.89-1.26), p for interaction 0.05).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Venetsanos', 'Affiliation': 'Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sederholm Lawesson', 'Affiliation': 'Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Fröbert', 'Affiliation': 'Department of Cardiology, Örebro University, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Omerovic', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Henareh', 'Affiliation': 'Department of Medicine, Karolinska Institute, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Robertsson', 'Affiliation': 'Department of Cardiology, Södra Älvsborgs Sjukhus, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Linder', 'Affiliation': 'Department of Cardiology, Danderyd Hospital, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Götberg', 'Affiliation': 'Department of Cardiology, Skåne University Hospital, Sweden.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Alfredsson', 'Affiliation': 'Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Cardiology, Skåne University Hospital, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Swahn', 'Affiliation': 'Department of Cardiology and Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}]",European heart journal. Acute cardiovascular care,['10.1177/2048872618803760']
815,30576268,Overall Survival of Black and White Men With Metastatic Castration-Resistant Prostate Cancer Treated With Docetaxel.,"PURPOSE


Several studies have reported that among patients with localized prostate cancer, black men have a shorter overall survival (OS) time than white men, but few data exist for men with advanced prostate cancer. The primary goal of this analysis was to compare the OS in black and white men with metastatic castration-resistant prostate cancer (mCRPC) who were treated in phase III clinical trials with docetaxel plus prednisone (DP) or a DP-containing regimen.
METHODS


Individual participant data from 8,820 men with mCRPC randomly assigned in nine phase III trials to DP or a DP-containing regimen were combined. Race was based on self-report. The primary end point was OS. The Cox proportional hazards regression model was used to assess the prognostic importance of race (black v white) adjusted for established risk factors common across the trials (age, prostate-specific antigen, performance status, alkaline phosphatase, hemoglobin, and sites of metastases).
RESULTS


Of 8,820 men, 7,528 (85%) were white, 500 (6%) were black, 424 (5%) were Asian, and 368 (4%) were of unknown race. Black men were younger and had worse performance status, higher testosterone and prostate-specific antigen, and lower hemoglobin than white men. Despite these differences, the median OS was 21.0 months (95% CI, 19.4 to 22.5 months) versus 21.2 months (95% CI, 20.8 to 21.7 months) in black and white men, respectively. The pooled multivariable hazard ratio of 0.81 (95% CI, 0.72 to 0.91) demonstrates that overall, black men have a statistically significant decreased risk of death compared with white men ( P < .001).
CONCLUSION


When adjusted for known prognostic factors, we observed a statistically significant increased OS in black versus white men with mCRPC who were enrolled in these clinical trials. The mechanism for these differences is not known.",2019,"Black men were younger and had worse performance status, higher testosterone and prostate-specific antigen, and lower hemoglobin than white men.","['patients with localized prostate cancer, black men', 'black versus white men with mCRPC', 'Individual participant data from 8,820 men with mCRPC randomly assigned in nine phase III trials to', 'black and white men with metastatic castration-resistant prostate cancer (mCRPC', 'men with advanced prostate cancer', 'Of 8,820 men, 7,528 (85%) were white, 500 (6%) were black, 424 (5%) were Asian, and 368 (4%) were of unknown race', 'Black men were younger and had worse performance status, higher testosterone and prostate-specific antigen, and lower hemoglobin than white men']","['DP', 'Docetaxel', 'docetaxel plus prednisone (DP) or a DP-containing regimen']","['OS', 'overall survival (OS) time', 'median OS', 'risk of death', 'Overall Survival of Black']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]",8820.0,0.119426,"Black men were younger and had worse performance status, higher testosterone and prostate-specific antigen, and lower hemoglobin than white men.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': '1 Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': '1 Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': '2 Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rosenthal', 'Affiliation': '3 The Royal Melbourne Hospital, Parkville, VIC, Australia.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Petrylak', 'Affiliation': '4 Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': '5 UT Health Science Center, San Antonio, TX.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': '6 BC Cancer Agency Vancouver Centre, Vancouver, BC.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Araujo', 'Affiliation': '7 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Logothetis', 'Affiliation': '7 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': '8 University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': '9 Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': '10 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Eisenberger', 'Affiliation': '11 The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'George', 'Affiliation': '1 Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Johann S', 'Initials': 'JS', 'LastName': 'De Bono', 'Affiliation': '12 The Institute of Cancer Research and The Royal Marsden National Health Service Foundation Trust, Sutton, United Kingdom.'}, {'ForeName': 'Celestia S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': '2 Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Ian F', 'Initials': 'IF', 'LastName': 'Tannock', 'Affiliation': '13 Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': '14 University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'William Kevin', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': '15 Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, PA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.18.01279']
816,29627695,"Mindfulness-based resilience training to reduce health risk, stress reactivity, and aggression among law enforcement officers: A feasibility and preliminary efficacy trial.","The primary objective of this study was to assess feasibility and gather preliminary outcome data on Mindfulness-Based Resilience Training (MBRT) for law enforcement officers. Participants (n = 61) were randomized to either an 8-week MBRT course or a no intervention control group. Self-report and physiological data were collected at baseline, post-training, and three months following intervention completion. Attendance, adherence, post-training participant feedback, and interventionist fidelity to protocol all demonstrated feasibility of MBRT for law enforcement officers. Compared to no intervention controls, MBRT participants experienced greater reductions in salivary cortisol, self-reported aggression, organizational stress, burnout, sleep disturbance, and reported increases in psychological flexibility and non-reactivity at post-training; however, group differences were not maintained at three-month follow-up. This initial randomized trial suggests MBRT is a feasible intervention. Outcome data suggest MBRT targets key physiological, psychological, and health risk factors in law enforcement officers, consistent with the potential to improve officer health and public safety. However, follow-up training or ""booster"" sessions may be needed to maintain training gains. A fully powered longitudinal randomized trial is warranted.",2018,"Compared to no intervention controls, MBRT participants experienced greater reductions in salivary cortisol, self-reported aggression, organizational stress, burnout, sleep disturbance, and reported increases in psychological flexibility and non-reactivity at post-training; however, group differences were not maintained at three-month follow-up.","['among law enforcement officers', 'Participants (n\u202f=\u202f61']","['Mindfulness-Based Resilience Training (MBRT', 'Mindfulness-based resilience training', '8-week MBRT course or a no intervention control group', 'MBRT']","['health risk, stress reactivity, and aggression', 'salivary cortisol, self-reported aggression, organizational stress, burnout, sleep disturbance', 'officer health and public safety', 'MBRT targets key physiological, psychological, and health risk factors', 'psychological flexibility and non-reactivity']","[{'cui': 'C0086529', 'cui_str': 'Law Enforcement Officers'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state (disorder)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",61.0,0.0318819,"Compared to no intervention controls, MBRT participants experienced greater reductions in salivary cortisol, self-reported aggression, organizational stress, burnout, sleep disturbance, and reported increases in psychological flexibility and non-reactivity at post-training; however, group differences were not maintained at three-month follow-up.","[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Christopher', 'Affiliation': 'School of Graduate Psychology, Pacific University, Hillsboro, OR, USA. Electronic address: mchristopher@pacifcu.edu.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hunsinger', 'Affiliation': 'School of Graduate Psychology, Pacific University, Hillsboro, OR, USA.'}, {'ForeName': 'Lt Richard J', 'Initials': 'LRJ', 'LastName': 'Goerling', 'Affiliation': 'School of Graduate Psychology, Pacific University, Hillsboro, OR, USA; Mindful Badge Initiative, Hillsboro, OR, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'School of Graduate Psychology, Pacific University, Hillsboro, OR, USA.'}, {'ForeName': 'Brant S', 'Initials': 'BS', 'LastName': 'Rogers', 'Affiliation': 'School of Graduate Psychology, Pacific University, Hillsboro, OR, USA; Stress Reduction Clinic, Hillsboro, OR, USA.'}, {'ForeName': 'Cynthia R', 'Initials': 'CR', 'LastName': 'Gross', 'Affiliation': 'College of Pharmacy and School of Nursing, University of Minnesota Twin Cities, Minneapolis, MN, USA.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Dapolonia', 'Affiliation': 'School of Graduate Psychology, Pacific University, Hillsboro, OR, USA.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Pruessner', 'Affiliation': 'Departments of Psychology, Psychiatry, Neurology and Neurosurgery, Douglas Institute, McGill University, Montreal, Quebec, Canada.'}]",Psychiatry research,['10.1016/j.psychres.2018.03.059']
817,31876947,Comparative Effectiveness of Cognitive Behavioral Therapy for Chronic Pain and Chronic Pain Self-Management within the Context of Voluntary Patient-Centered Prescription Opioid Tapering: The EMPOWER Study Protocol.,"OBJECTIVE


Evidence to date, while sparse, suggests that patients taking long-term opioids require special considerations and protections to prevent potential iatrogenic harms from opioid de-prescribing, such as increased pain or suffering. Following this study protocol, the EMPOWER study seeks to address multiple unmet needs of patients with chronic pain who desire to reduce long-term opioid therapy, and provide the clinical evidence on effective methodology.
METHODS


EMPOWER applies patient-centered methods for voluntary prescription opioid reduction conducted within a comprehensive, multi-state, 3-arm randomized controlled comparative effectiveness study of three study arms (1) group cognitive behavioral therapy for chronic pain; (2) group chronic pain self-management; and (3) usual care (taper only). Specialized electronic data capture systems collect patient reported symptoms and satisfaction data weekly and monthly during the taper, with real-time clinical alerts and electronic feedback loops informing, documenting, and steering needed care actions.
CONCLUSION


The EMPOWER study seeks to provide granular evidence on patient response to voluntary opioid tapering, and will provide evidence to inform clinical systems changes, clinical care, patient satisfaction, and patient outcomes for opioid reduction.",2020,"OBJECTIVE


Evidence to date, while sparse, suggests that patients taking long-term opioids require special considerations and protections to prevent potential iatrogenic harms from opioid de-prescribing, such as increased pain or suffering.",['patients with chronic pain who desire to reduce long-term opioid therapy'],"['cognitive behavioral therapy', 'Cognitive Behavioral Therapy', 'chronic pain self-management; and (3) usual care (taper only']",['Chronic Pain and Chronic Pain Self-Management'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]",,0.0744989,"OBJECTIVE


Evidence to date, while sparse, suggests that patients taking long-term opioids require special considerations and protections to prevent potential iatrogenic harms from opioid de-prescribing, such as increased pain or suffering.","[{'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Darnall', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Sean C', 'Initials': 'SC', 'LastName': 'Mackey', 'Affiliation': 'Division of Pain Medicine, Stanford Systems Neuroscience and Pain Lab, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Lorig', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Ming-Chih', 'Initials': 'MC', 'LastName': 'Kao', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Aram', 'Initials': 'A', 'LastName': 'Mardian', 'Affiliation': 'Department of Family, Community, and Preventive Medicine, Phoenix VA Health Care System, Chronic Pain Wellness Center, University of Arizona College of Medicine-Phoenix, Phoenix, Arizona.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stieg', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Porter', 'Affiliation': 'Department of Family Medicine, Intermountain Healthcare, Layton, Utah.'}, {'ForeName': 'Korina', 'Initials': 'K', 'LastName': 'DeBruyne', 'Affiliation': 'Division of Primary, Preventive and, Community Care, Stanford School of Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': ""James A. Haley Veterans' Hospital, University of South Florida School of Medicine, Tampa, Florida.""}, {'ForeName': 'Luzmercy', 'Initials': 'L', 'LastName': 'Perez', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Okvat', 'Affiliation': 'Department of Family, Community, and Preventive Medicine, Phoenix VA Health Care System, Chronic Pain Wellness Center, University of Arizona College of Medicine-Phoenix, Phoenix, Arizona.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Tian', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Flood', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'McGovern', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'University of Maryland School of Nursing, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'King', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Palo Alto, California.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Van Dorsten', 'Affiliation': 'Colorado Center for Behavioral Medicine, Denver, Colorado.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Pun', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Cheung', 'Affiliation': 'Thomas J. Long School of Pharmacy, University of the Pacific, Stockton, California, USA.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz285']
818,29504820,Three-step Reduction Therapy of Integrated Chinese and Western Medicine for Thoracolumbar Burst Fracture.,"Objective:  To investigate and compare the efficacy of three-step reduction (TSR) therapy of integrated Chinese and Western Medicine and posterior open (PO) surgery for thoracolumbar burst fracture.  Methods:  We selected 60 patients diagnosed with thoracolumbar burst fracture and received treatment in our hospital from December 2014 to March 2017. According to randomized digital table, they were randomly divided into TSR and PO groups. VAS pain grade, Oswestry disability index, height of centrum front, Cobb's angle of spine, bleeding, and complication of internal fixation of the two groups were compared.  Results:  Postoperative reduction of injured centrum, regained volume of canalis vertebralis, volume of bleeding, and early functional rehabilitation of TSR group were better than that of PO groups ( P  < 0.05).  Conclusion:  Through three-step reduction combined pedicle screw fixation surgery, we can achieve satisfied reduction of thoracolumbar burst fracture, rebuild the height of centrum, recover the biomechanics function of spine, and reduce bleeding. Three-step reduction therapy is an effective therapy for thoracolumbar burst fracture.",2019,"RESULTS


Postoperative reduction of injured centrum, regained volume of canalis vertebralis, volume of bleeding, and early functional rehabilitation of TSR group were better than that of PO groups (P < 0.05).
",['60 patients diagnosed with thoracolumbar burst fracture and received treatment in our hospital from December 2014 to March 2017'],"['combined pedicle screw fixation surgery', 'three-step reduction (TSR) therapy of integrated Chinese and Western Medicine and posterior open (PO) surgery']","[""VAS pain grade, Oswestry disability index, height of centrum front, Cobb's angle of spine, bleeding, and complication of internal fixation"", 'Postoperative reduction of injured centrum, regained volume of canalis vertebralis, volume of bleeding, and early functional rehabilitation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}, {'cui': 'C0859903', 'cui_str': 'Burst fracture'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0563192', 'cui_str': 'Cobb angle (observable entity)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0454532', 'cui_str': 'Functional rehabilitation (regime/therapy)'}]",60.0,0.0153025,"RESULTS


Postoperative reduction of injured centrum, regained volume of canalis vertebralis, volume of bleeding, and early functional rehabilitation of TSR group were better than that of PO groups (P < 0.05).
","[{'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Decheng', 'Affiliation': 'Department of Orthopedics, Tongzhou District traditional Chinese and Western medicine hospital, Beijing, China.'}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Hao', 'Affiliation': 'Department of Orthopedics, Tongzhou District traditional Chinese and Western medicine hospital, Beijing, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Zhongwei', 'Affiliation': 'Department of Orthopedics, Tongzhou District traditional Chinese and Western medicine hospital, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jiaming', 'Affiliation': 'Department of Orthopedics, Tongzhou District traditional Chinese and Western medicine hospital, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Bin', 'Affiliation': 'Department of Orthopedics, Tongzhou District traditional Chinese and Western medicine hospital, Beijing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Yong', 'Affiliation': 'Department of Orthopedics, Beijing Chao-Yang hospital of Capital Medical University, Beijing, China.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2018.1442534']
819,30398602,Effect of Inorganic Nitrite vs Placebo on Exercise Capacity Among Patients With Heart Failure With Preserved Ejection Fraction: The INDIE-HFpEF Randomized Clinical Trial.,"Importance


There are few effective treatments for heart failure with preserved ejection fraction (HFpEF). Short-term administration of inorganic nitrite or nitrate preparations has been shown to enhance nitric oxide signaling, which may improve aerobic capacity in HFpEF.
Objective


To determine the effect of 4 weeks' administration of inhaled, nebulized inorganic nitrite on exercise capacity in HFpEF.
Design, Setting, and Participants


Multicenter, double-blind, placebo-controlled, 2-treatment, crossover trial of 105 patients with HFpEF. Participants were enrolled from July 22, 2016, to September 12, 2017, at 17 US sites, with final date of follow-up of January 2, 2018.
Interventions


Inorganic nitrite or placebo administered via micronebulizer device. During each 6-week phase of the crossover study, participants received no study drug for 2 weeks (baseline/washout) followed by study drug (nitrite or placebo) at 46 mg 3 times a day for 1 week followed by 80 mg 3 times a day for 3 weeks.
Main Outcomes and Measures


The primary end point was peak oxygen consumption (mL/kg/min). Secondary end points included daily activity levels assessed by accelerometry, health status as assessed by the Kansas City Cardiomyopathy Questionnaire (score range, 0-100, with higher scores reflecting better quality of life), functional class, cardiac filling pressures assessed by echocardiography, N-terminal fragment of the prohormone brain natriuretic peptide levels, other exercise indices, adverse events, and tolerability. Outcomes were assessed after treatment for 4 weeks.
Results


Among 105 patients who were randomized (median age, 68 years; 56% women), 98 (93%) completed the trial. During the nitrite phase, there was no significant difference in mean peak oxygen consumption as compared with the placebo phase (13.5 vs 13.7 mL/kg/min; difference, -0.20 [95% CI, -0.56 to 0.16]; P = .27). There were no significant between-treatment phase differences in daily activity levels (5497 vs 5503 accelerometry units; difference, -15 [95% CI, -264 to 234]; P = .91), Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (62.6 vs 61.9; difference, 1.1 [95% CI, -1.4 to 3.5]; P = .39), functional class (2.5 vs 2.5; difference, 0.1 [95% CI, -0.1 to 0.2]; P = .43), echocardiographic E/e' ratio (16.4 vs 16.6; difference, 0.1 [95% CI, -1.2 to 1.3]; P = .93), or N-terminal fragment of the prohormone brain natriuretic peptide levels (520 vs 533 pg/mL; difference, 11 [95% CI, -53 to 75]; P = .74). Worsening heart failure occurred in 3 participants (2.9%) during the nitrite phase and 8 (7.6%) during the placebo phase.
Conclusions and Relevance


Among patients with HFpEF, administration of inhaled inorganic nitrite for 4 weeks, compared with placebo, did not result in significant improvement in exercise capacity.
Trial Registration


ClinicalTrials.gov Identifier: NCT02742129.",2018,"There were no significant between-treatment phase differences in daily activity levels (5497 vs 5503 accelerometry units; difference, -15 [95% CI, -264 to 234]; P = .91), Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (62.6 vs 61.9; difference, 1.1 [95% CI, -1.4 to 3.5]; P = .39), functional class (2.5 vs 2.5; difference, 0.1 [95% CI, -0.1 to 0.2]; P = .43), echocardiographic E/e' ratio (16.4 vs 16.6; difference, 0.1","['patients with HFpEF', 'Participants were enrolled from July 22, 2016, to September 12, 2017, at 17 US sites, with final date of follow-up of January 2, 2018', '105 patients with HFpEF', '105 patients who were randomized (median age, 68 years; 56% women), 98 (93%) completed the trial', 'Patients With Heart Failure With Preserved Ejection Fraction']","['study drug (nitrite or placebo', 'Inorganic nitrite or placebo', 'placebo', 'inhaled inorganic nitrite', 'inhaled, nebulized inorganic nitrite', 'Inorganic Nitrite vs Placebo', 'inorganic nitrite or nitrate preparations']","['daily activity levels assessed by accelerometry, health status as assessed by the Kansas City Cardiomyopathy Questionnaire (score range, 0-100, with higher scores reflecting better quality of life), functional class, cardiac filling pressures assessed by echocardiography, N-terminal fragment of the prohormone brain natriuretic peptide levels, other exercise indices, adverse events, and tolerability', 'prohormone brain natriuretic peptide levels', 'mean peak oxygen consumption', 'Exercise Capacity', 'daily activity levels', 'functional class', 'peak oxygen consumption', 'exercise capacity', 'Worsening heart failure', 'Kansas City Cardiomyopathy Questionnaire Clinical Summary Score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0104487', 'cui_str': 'AT 17'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0332255', 'cui_str': 'Fragment of (qualifier value)'}, {'cui': 'C4087252', 'cui_str': 'Prohormone brain natriuretic peptide'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",105.0,0.734265,"There were no significant between-treatment phase differences in daily activity levels (5497 vs 5503 accelerometry units; difference, -15 [95% CI, -264 to 234]; P = .91), Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (62.6 vs 61.9; difference, 1.1 [95% CI, -1.4 to 3.5]; P = .39), functional class (2.5 vs 2.5; difference, 0.1 [95% CI, -0.1 to 0.2]; P = .43), echocardiographic E/e' ratio (16.4 vs 16.6; difference, 0.1","[{'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Borlaug', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Levine', 'Affiliation': 'Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Gabe A', 'Initials': 'GA', 'LastName': 'Koepp', 'Affiliation': 'Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'LeWinter', 'Affiliation': 'University of Vermont Medical Center, Burlington.'}, {'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Mann', 'Affiliation': 'Washington University, St Louis, Missouri.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Margulies', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Smith', 'Affiliation': 'Emory School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'W H Wilson', 'Initials': 'WHW', 'LastName': 'Tang', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Whellan', 'Affiliation': 'Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Horng H', 'Initials': 'HH', 'LastName': 'Chen', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Victor G', 'Initials': 'VG', 'LastName': 'Davila-Roman', 'Affiliation': 'Washington University, St Louis, Missouri.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, Maryland.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2018.14852']
820,31661579,Medication-overuse headache: The effect of a patient educational programme-A randomized controlled trial.,"BACKGROUND


Little is known about the effects of non-pharmacological interventions among medication-overuse headache (MOH) patients, although non-pharmacological approaches combined with pharmacological treatment are recommended. The objective was to evaluate the effect of an educational programme as an add-on to standard treatment.
METHODS


Medication-overuse headache patients were randomized (1:1) in a single-centre setting to standard treatment with 12 weeks of education (I-group) versus standard treatment (C-group). The primary outcome was measurement of reduction in headache days/last month at 9 months' follow-up. Secondary outcomes were headache intensity, acute medication intake, bothersomeness, disability, physical activity and patient satisfaction. The between-group differences were analysed using a mixed-effects model for repeated measurements with a between group factor (I-group vs. C-group) and a time factor (baseline, 4 and 9 months).
RESULTS


Ninety-eight patients were randomized (I-group: n = 48, C-group: n = 50), with 40 and 39 patients completing the study, respectively. Intention-to-treat analyses showed that both groups experienced statistically significant reductions in headache days/last month (I-group: -4 ± 6 days (95% CI 2.47; 5.95), p < .001) versus C-group: -4 ± 9 days ([95% CI 1.53; 6.79], p = .003), but there were no significant differences between groups (mean ± SE):Δ: 0.7 days ([95% CI, -2.50; 3.93], p = .66). At follow-up, 85% from the I-group and 86% from C-group, no longer fulfilled the criteria for MOH.
CONCLUSION


The compliance rate was high, indicating that patients were motivated for receiving education, but we found no additional benefits of adding an educational programme to standard treatment. Future research focusing on the MOH complexity, group heterogeneity, duration and content of educational programmes is warranted.
SIGNIFICANCE


Randomized controlled trials (RCTs) of non-pharmacological intervention such as patient educational programmes are of great importance, as this approach is common in the clinical practice. Medication-overuse headache (MOH) is a heterogenetic patient group, which must be taken into account when conducting RCTs of non-pharmacological interventions. An educational programme based on Motivational Interviewing is well-tolerated among MOH patients, however, no superior effects were found from adding the educational programme to standard treatment versus standard treatment alone.",2020,"Secondary outcomes were headache intensity, acute medication intake, bothersomeness, disability, physical activity, and patient satisfaction.","['Ninety-eight patients were randomized (I-group', 'n=48, C-group: n= 50), with 40 and 39 patients completing the study, respectively', 'MOH patients']","['educational program', 'patient educational program']","['compliance rate', 'headache intensity, acute medication intake, bothersomeness, disability, physical activity, and patient satisfaction', 'reduction in headache days/last month', 'headache days', 'Medication-overuse headache']","[{'cui': 'C4319627', 'cui_str': 'Ninety-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0522254', 'cui_str': 'Analgesic Overuse Headache'}]",98.0,0.124211,"Secondary outcomes were headache intensity, acute medication intake, bothersomeness, disability, physical activity, and patient satisfaction.","[{'ForeName': 'Louise S', 'Initials': 'LS', 'LastName': 'Mose', 'Affiliation': 'Department of Neurology, University Hospital of Southern Denmark, Esbjerg, Denmark.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Pedersen', 'Affiliation': 'Department of Psychology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Rigmor H', 'Initials': 'RH', 'LastName': 'Jensen', 'Affiliation': 'Department of Neurology, Danish Headache Centre, Rigshospitalet-Glostrup, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bibi', 'Initials': 'B', 'LastName': 'Gram', 'Affiliation': 'Research Unit of Health Sciences, University Hospital of Southern Denmark, Esbjerg, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1500']
821,30361170,"Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone in advanced melanoma (CheckMate 067): 4-year outcomes of a multicentre, randomised, phase 3 trial.","BACKGROUND


Previously reported results from the phase 3 CheckMate 067 trial showed a significant improvement in objective responses, progression-free survival, and overall survival with nivolumab plus ipilimumab or nivolumab alone compared with ipilimumab alone in patients with advanced melanoma. The aim of this report is to provide 4-year updated efficacy and safety data from this study.
METHODS


In this phase 3 trial, eligible patients were aged 18 years or older with previously untreated, unresectable, stage III or stage IV melanoma, known BRAF V600  mutation status, and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned 1:1:1 to receive intravenous nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for four doses, followed by nivolumab 3 mg/kg every 2 weeks, or nivolumab 3 mg/kg every 2 weeks plus placebo, or ipilimumab 3 mg/kg every 3 weeks for four doses plus placebo. Randomisation was done via an interactive voice response system with a permuted block schedule (block size of six) and stratification by PD-L1 status, BRAF mutation status, and metastasis stage. The patients, investigators, study site staff, and study funder were masked to the study drug administered. The co-primary endpoints were progression-free survival and overall survival. Efficacy analyses were done on the intention-to-treat population, whereas safety was assessed in all patients who received at least one dose of study drug. The results presented in this report reflect the 4-year update of the ongoing study with a database lock date of May 10, 2018. This study is registered with ClinicalTrials.gov, number NCT01844505.
FINDINGS


Between July 3, 2013, and March 31, 2014, 945 patients were enrolled and randomly assigned to nivolumab plus ipilimumab (n=314), nivolumab (n=316), or ipilimumab (n=315). Median follow-up was 46·9 months (IQR 10·9-51·8) in the nivolumab plus ipilimumab group, 36·0 months (10·5-51·4) in the nivolumab group, and 18·6 months (7·6-49·5) in the ipilimumab group. At a minimum follow-up of 48 months from the date that the final patient was enrolled and randomised, median overall survival was not reached (95% CI 38·2-not reached) in the nivolumab plus ipilimumab group, 36·9 months (28·3-not reached) in the nivolumab group, and 19·9 months (16·9-24·6) in the ipilimumab group. The hazard ratio for death for the combination versus ipilimumab was 0·54 (95% CI 0·44-0·67; p<0·0001) and for nivolumab versus ipilimumab was 0·65 (0·53-0·79; p<0·0001). Median progression-free survival was 11·5 months (95% CI 8·7-19·3) in the nivolumab plus ipilimumab group, 6·9 months (5·1-10·2) in the nivolumab group, and 2·9 months (2·8-3·2) in the ipilimumab group. The hazard ratio for progression-free survival for the combination versus ipilimumab was 0·42 (95% CI 0·35-0·51; p<0·0001) and for nivolumab versus ipilimumab was 0·53 (0·44-0·64; p<0·0001). Treatment-related grade 3-4 adverse events were reported in 185 (59%) of 313 patients who received nivolumab plus ipilimumab, 70 (22%) of 313 who received nivolumab, and 86 (28%) of 311 who received ipilimumab. The most common treatment-related grade 3 adverse events were diarrhoea in the nivolumab plus ipilimumab group (29 [9%] of 313) and in the nivolumab group (nine [3%] of 313) and colitis in the ipilimumab group (23 [7%] of 311); the most common grade 4 adverse event in all three groups was increased lipase (15 [5%] of 313 in the combination group, ten [3%] of 313 in the nivolumab group, and four [1%] of 311 in the ipilimumab group). Serious adverse events were not analysed for the 4-year follow-up. In total for the study, there were four treatment-related deaths: two in the nivolumab plus ipilimumab group (one cardiomyopathy and one liver necrosis), one in the nivolumab group (neutropenia), and one in the ipilimumab group (colon perforation). No additional treatment-related deaths have occurred since the previous (3-year) analysis.
INTERPRETATION


The results of this analysis at 4 years of follow-up show that a durable, sustained survival benefit can be achieved with first-line nivolumab plus ipilimumab or nivolumab alone in patients with advanced melanoma.
FUNDING


Bristol-Myers Squibb.",2018,The hazard ratio for death for the combination versus ipilimumab was 0·54,"['eligible patients were aged 18 years or older with previously untreated, unresectable, stage III or stage IV melanoma, known BRAF V600  mutation status, and an Eastern Cooperative Oncology Group performance status of 0 or 1', 'patients with advanced melanoma', 'group (one cardiomyopathy and one liver necrosis), one in the nivolumab group (neutropenia), and one in the ipilimumab group (colon perforation', 'advanced melanoma (CheckMate 067', 'Between July 3, 2013, and March 31, 2014, 945 patients']","['placebo', 'Nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone', 'nivolumab versus ipilimumab', 'nivolumab plus ipilimumab', 'nivolumab (n=316), or ipilimumab', 'ipilimumab', 'nivolumab 3 mg/kg every 2 weeks plus placebo, or ipilimumab', 'intravenous nivolumab 1 mg/kg plus ipilimumab']","['hazard ratio for progression-free survival', 'colitis', 'progression-free survival and overall survival', 'diarrhoea', 'objective responses, progression-free survival, and overall survival', 'hazard ratio for death', 'median overall survival', 'deaths', 'Median progression-free survival', 'Serious adverse events', 'lipase']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0151798', 'cui_str': 'Hepatic necrosis (disorder)'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0347646', 'cui_str': 'Perforation of colon (disorder)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0009319', 'cui_str': 'Colitis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}]",945.0,0.431166,The hazard ratio for death for the combination versus ipilimumab was 0·54,"[{'ForeName': 'Frank Stephen', 'Initials': 'FS', 'LastName': 'Hodi', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: stephen_hodi@dfci.harvard.edu.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': 'Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Gonzalez', 'Affiliation': 'University of Colorado Cancer Center, Denver, CO, USA.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix-Marseille University and APHM Hospital CHU Timone, Marseille, France.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Maria Skłodowska-Curie Institute - Oncology Centre, Warsaw, Poland.'}, {'ForeName': 'Charles Lance', 'Initials': 'CL', 'LastName': 'Cowey', 'Affiliation': 'Texas Oncology-Baylor Charles A Sammons Cancer Center, Dallas, TX, USA.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Lao', 'Affiliation': 'Department of Oncology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University of Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wagstaff', 'Affiliation': 'The College of Medicine, Swansea University, Swansea, UK.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Department of Dermatology, Universitäts Spital, Zürich, Switzerland.'}, {'ForeName': 'Pier Francesco', 'Initials': 'PF', 'LastName': 'Ferrucci', 'Affiliation': 'European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Smylie', 'Affiliation': 'Cross Cancer Institute, Edmonton, AB, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Tasman Oncology Research, Southport, QLD, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hogg', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Marquez-Rodas', 'Affiliation': 'General University Hospital Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Rizzo', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jedd D', 'Initials': 'JD', 'LastName': 'Wolchok', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Cornell Medical College, New York, NY, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(18)30700-9']
822,31847913,Community interventions to prevent violence against women and girls in informal settlements in Mumbai: the SNEHA-TARA pragmatic cluster randomised controlled trial.,"BACKGROUND


In a cluster randomised controlled trial in Mumbai slums, we will test the effects on the prevalence of violence against women and girls of community mobilisation through groups and individual volunteers. One in three women in India has survived physical or sexual violence, making it a major public health burden. Reviews recommend community mobilisation to address violence, but trial evidence is limited.
METHODS


Guided by a theory of change, we will compare 24 areas receiving support services, community group, and volunteer activities with 24 areas receiving support services only. These community mobilisation activities will be evaluated through a follow-up survey after 3 years. Primary outcomes will be prevalence in the preceding year of physical or sexual domestic violence, and prevalence of emotional or economic domestic violence, control, or neglect against women 15-49 years old. Secondary outcomes will describe disclosure of violence to support services, community tolerance of violence against women and girls, prevalence of non-partner sexual violence, and mental health and wellbeing. Intermediate theory-based outcomes will include bystander intervention, identification of and support for survivors of violence, changes described in programme participants, and changes in communities.
DISCUSSION


Systematic reviews of interventions to prevent violence against women and girls suggest that community mobilisation is a promising population-based intervention. Already implemented in other areas, our intervention has been developed over 16 years of programmatic experience and 2 years of formative research. Backed by public engagement and advocacy, our vision is of a replicable community-led intervention to address the public health burden of violence against women and girls.
TRIAL REGISTRATION


Controlled Trials Registry of India, CTRI/2018/02/012047. Registered on 21 February 2018. ISRCTN, ISRCTN84502355. Registered on 22 February 2018.",2019,"Secondary outcomes will describe disclosure of violence to support services, community tolerance of violence against women and girls, prevalence of non-partner sexual violence, and mental health and wellbeing.","['violence against women and girls of community mobilisation through groups and individual volunteers', 'violence against women and girls in informal settlements in Mumbai']",['Community interventions'],"['prevalence in the preceding year of physical or sexual domestic violence, and prevalence of emotional or economic domestic violence, control, or neglect against women 15-49\u2009years old', 'disclosure of violence to support services, community tolerance of violence against women and girls, prevalence of non-partner sexual violence, and mental health and wellbeing', 'survived physical or sexual violence']","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0185112', 'cui_str': 'Mobilizing (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0206073', 'cui_str': 'Domestic Violence'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.165422,"Secondary outcomes will describe disclosure of violence to support services, community tolerance of violence against women and girls, prevalence of non-partner sexual violence, and mental health and wellbeing.","[{'ForeName': 'Nayreen', 'Initials': 'N', 'LastName': 'Daruwalla', 'Affiliation': 'SNEHA (Society for Nutrition, Education and Health Action), 310, 3rd floor, Urban Health Centre, 60 Feet Road, Dharavi, Mumbai, Maharashtra, 400017, India.'}, {'ForeName': 'Unnati', 'Initials': 'U', 'LastName': 'Machchhar', 'Affiliation': 'SNEHA (Society for Nutrition, Education and Health Action), 310, 3rd floor, Urban Health Centre, 60 Feet Road, Dharavi, Mumbai, Maharashtra, 400017, India.'}, {'ForeName': 'Shanti', 'Initials': 'S', 'LastName': 'Pantvaidya', 'Affiliation': 'SNEHA (Society for Nutrition, Education and Health Action), 310, 3rd floor, Urban Health Centre, 60 Feet Road, Dharavi, Mumbai, Maharashtra, 400017, India.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': ""D'Souza"", 'Affiliation': 'SNEHA (Society for Nutrition, Education and Health Action), 310, 3rd floor, Urban Health Centre, 60 Feet Road, Dharavi, Mumbai, Maharashtra, 400017, India.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Gram', 'Affiliation': 'University College London Institute for Global Health, 30 Guilford Street, London, WC1N 1EH, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Copas', 'Affiliation': 'Institute of Clinical Trials and Methodology, 90 High Holborn, London, WC1V 6LJ, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Osrin', 'Affiliation': 'University College London Institute for Global Health, 30 Guilford Street, London, WC1N 1EH, UK. d.osrin@ucl.ac.uk.'}]",Trials,['10.1186/s13063-019-3817-2']
823,30419040,Safety of azithromycin in infants under six months of age in Niger: A community randomized trial.,"BACKGROUND


Mass azithromycin distribution reduces under-5 child mortality. Trachoma control programs currently treat infants aged 6 months and older. Here, we report findings from an infant adverse event survey in 1-5 month olds who received azithromycin as part of a large community-randomized trial in Niger.
METHODS AND PRINCIPAL FINDINGS


Active surveillance of infants aged 1-5 months at the time of treatment was conducted in 30 randomly selected communities from within a large cluster randomized trial of biannual mass azithromycin distribution compared to placebo to assess the potential impact on child mortality. We compared the distribution of adverse events reported after treatment among azithromycin-treated versus placebo-treated infants. From January 2015 to February 2018, the caregivers of 1,712 infants were surveyed. Approximately one-third of caregivers reported at least one adverse event (azithromycin: 29.6%, placebo: 34.3%, risk ratio [RR] 0.86, 95% confidence interval [CI] 0.68 to 1.10, P = 0.23). The most commonly reported adverse events included diarrhea (azithromycin: 19.3%, placebo: 28.1%, RR 0.68, 95% CI 0.49 to 0.96, P = 0.03), vomiting (azithromycin: 15.9%, placebo: 21.0%, RR 0.76, 95% CI 0.56 to 1.02, P = 0.07), and skin rash (azithromycin: 12.3%, placebo: 13.6%, RR 0.90, 95% CI 0.59 to 1.37, P = 0.63). No cases of infantile hypertrophic pyloric stenosis were reported.
CONCLUSIONS


Azithromycin given to infants aged 1-5 months appeared to be safe. Inclusion of younger infants in larger azithromycin-based child mortality or trachoma control programs could be considered if deemed effective.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02048007.",2018,"Approximately one-third of caregivers reported at least one adverse event (azithromycin: 29.6%, placebo: 34.3%, risk ratio [RR] 0.86, 95% confidence interval [CI] 0.68 to 1.10, P = 0.23).","['younger infants in larger azithromycin-based child mortality or trachoma control programs', 'infants under six months of age in Niger', 'infants aged 6 months and older', 'From January 2015 to February 2018, the caregivers of 1,712 infants were surveyed']","['biannual mass azithromycin', 'Azithromycin', 'azithromycin', 'placebo']","['infantile hypertrophic pyloric stenosis', 'vomiting', 'skin rash', 'adverse events', 'diarrhea']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008083', 'cui_str': 'Child Mortality'}, {'cui': 'C0040592', 'cui_str': 'Egyptian Ophthalmia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1867403', 'cui_str': 'Pyloric Stenosis, Infantile Hypertrophic'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",30.0,0.638437,"Approximately one-third of caregivers reported at least one adverse event (azithromycin: 29.6%, placebo: 34.3%, risk ratio [RR] 0.86, 95% confidence interval [CI] 0.68 to 1.10, P = 0.23).","[{'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Ramatou', 'Initials': 'R', 'LastName': 'Maliki', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Mohamed Salissou', 'Initials': 'MS', 'LastName': 'Kane', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ray', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Sun Y', 'Initials': 'SY', 'LastName': 'Cotter', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Zhaoxia', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'The Dana Center, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Bailey', 'Affiliation': 'Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0006950']
824,30641146,A Pilot Study of the Effect of an Educational Web Application on Asthma Control and Medication Adherence.,"BACKGROUND


An Asthma Adherence Pathway (AAP) application, which is an Internet application that combines patient and clinician education strategies to promote adherence to asthma therapy, has been developed.
OBJECTIVE


The primary objective of this pilot study was to evaluate the effectiveness of the AAP application with electronic adherence monitors on asthma control. Secondary objectives evaluated the effect of AAP and monitors on medication adherence, asthma symptoms, quality of life, psychosocial factors, and barriers to treatment.
METHODS


Adult patients with asthma were randomly assigned either to intervention (n = 19) or control (n = 20) groups in this 3-month prospective study, and they completed the Asthma Control Questionnaire (ACQ). Intervention patients completed the AAP software and were given barrier-specific motivational interviewing adherence strategies and a SmartTrack device to monitor mometasone furoate/formoterol (MF/F) use. Clinicians in the interventional group received adherence management training. Interventional patients were given feedback regarding adherence findings at each visit. Treatment adherence was determined by the mean of 4 measures of doses taken over 3 months. Control patients were not monitored for MF/F adherence.
RESULTS


The mean MF/F adherence in the intervention group was 81%. The intervention and control groups did not differ on the mean baseline ACQ. Thirteen intervention patients achieved the minimal important difference (defined as an improvement ≥0.5 units on the ACQ) compared with 6 control patients (P = .016). The intervention group showed greater improvement in the ACQ (0.75) than the control group (0.19) representing a moderate-to-large effect size of d = 0.638.
CONCLUSIONS


The AAP was effective in promoting adherence and helped to improve asthma control. These findings provide preliminary validation of the AAP model.",2019,"The intervention group showed greater improvement in the ACQ (0.75) than the control group (0.19) representing a moderate-to-large effect size of d = 0.638.
",['Adult patients with asthma'],"['AAP application with electronic adherence monitors', 'Educational Web Application', 'Asthma Control Questionnaire (ACQ', 'AAP', 'adherence management training', 'AAP software and were given barrier-specific motivational interviewing adherence strategies and a SmartTrack device to monitor mometasone furoate/formoterol (MF/F) use']","['asthma control', 'Treatment adherence', 'mean MF/F adherence', 'MF/F adherence', 'effect of AAP and monitors on medication adherence, asthma symptoms, quality of life, psychosocial factors, and barriers to treatment', 'ACQ', 'Asthma Control and Medication Adherence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]","[{'cui': 'C0051989', 'cui_str': 'Gly-Pro-HyPro-Gly-Ala-Gly'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0066700', 'cui_str': 'mometasone furoate'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0051989', 'cui_str': 'Gly-Pro-HyPro-Gly-Ala-Gly'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0317045,"The intervention group showed greater improvement in the ACQ (0.75) than the control group (0.19) representing a moderate-to-large effect size of d = 0.638.
","[{'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Weinstein', 'Affiliation': 'Department of Pediatrics, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pa. Electronic address: agwmd@aol.com.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Pulmonary and Critical Care, Allegheny General Hospital, Pittsburgh, Pa.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Laurenceau', 'Affiliation': 'Department of Psychology and Brain Sciences, University of Delaware, Newark, Del.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Skoner', 'Affiliation': 'Department of Pediatrics, West Virginia University School of Medicine, Morgantown, WVa.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Maiolo', 'Affiliation': 'Department of Rheumatology, Allegheny General Hospital, Pittsburgh, Pa.'}, {'ForeName': 'Rihab', 'Initials': 'R', 'LastName': 'Sharara', 'Affiliation': 'Department of Pulmonary and Critical Care, Allegheny General Hospital, Pittsburgh, Pa.'}, {'ForeName': 'Kiet', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'Department of Pulmonary and Critical Care, Allegheny General Hospital, Pittsburgh, Pa.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Cheema', 'Affiliation': 'Department of Pulmonary and Critical Care, Allegheny General Hospital, Pittsburgh, Pa.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Butler', 'Affiliation': 'Department of Allergy, Asthma, and Immunology, Pediatric Alliance, Pittsburgh, Pa.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kong', 'Affiliation': 'Department of Allergy, Asthma, and Immunology, Allegheny General Hospital, Pittsburgh, Pa.'}, {'ForeName': 'Payal', 'Initials': 'P', 'LastName': 'Thakkar', 'Affiliation': 'Allegheny Singer Research Institute, Allegheny General Hospital, Pittsburgh, Pa.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Gentile', 'Affiliation': 'Department of Allergy, Asthma, and Immunology, Pediatric Alliance, Pittsburgh, Pa.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2018.12.024']
825,29679844,Measuring impairment when diagnosing adolescent ADHD: Differentiating problems due to ADHD versus other sources.,"The DSM-5 requires clinicians to link ADHD symptoms to clinically meaningful impairments in daily life functioning. Measuring impairment during ADHD assessments may be particularly challenging in adolescence, when ADHD is often not the sole source of a youth's difficulties. Existing impairment rating scales are criticized for not specifying ADHD as the source of impairment in their instructions, leading to potential problems with rating scale specificity. The current study utilized a within subjects design (N = 107) to compare parent report of impairment on two versions of a global impairment measure: one that specified ADHD as the source of impairment (Impairment Rating Scale-ADHD) and a standard version that did not (Impairment Rating Scale). On the standard family impairment item, parents endorsed greater impairment as compared to the IRS-ADHD. This finding was particularly pronounced when parents reported high levels of parenting stress. More severe ADHD symptoms were associated with greater concordance between the two versions. Findings indicate that adolescent family related impairments reported during ADHD assessments may be due to sources other than ADHD symptoms, such as developmental maladjustment. To prevent false positive diagnoses, symptom-specific wording may optimize impairment measures when assessing family functioning in diagnostic assessments for adolescents with ADHD.",2018,"On the standard family impairment item, parents endorsed greater impairment as compared to the IRS-ADHD.",['adolescents with ADHD'],[],"['severe ADHD symptoms', 'source of impairment (Impairment Rating Scale-ADHD) and a standard version that did not (Impairment Rating Scale']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]",,0.0151185,"On the standard family impairment item, parents endorsed greater impairment as compared to the IRS-ADHD.","[{'ForeName': 'Alejandro L', 'Initials': 'AL', 'LastName': 'Vazquez', 'Affiliation': 'Department of Psychology, Utah State University, Logan, UT, United States. Electronic address: Alejandro.vazquez@aggiemail.usu.edu.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Sibley', 'Affiliation': 'Department of Psychiatry & Behavioral Health, Florida International University, Miami, Florida, United States.'}, {'ForeName': 'Mileini', 'Initials': 'M', 'LastName': 'Campez', 'Affiliation': 'Department of Psychology, Florida International University, Miami, Florida, United States.'}]",Psychiatry research,['10.1016/j.psychres.2018.03.083']
826,32409106,Safety Analysis of Five Randomized Controlled Studies of Daratumumab in Patients With Multiple Myeloma.,"BACKGROUND


Multiple studies have demonstrated the efficacy and safety of daratumumab for relapsed/refractory multiple myeloma (MM) and primary treatment for transplant-eligible and -ineligible patients.
MATERIALS AND METHODS


We conducted an integrated safety analysis to characterize the frequency, severity, natural history, and outcomes of adverse events (AEs) with daratumumab versus comparators. Data were pooled from 5 completed phase III randomized controlled studies that had included 1798 daratumumab-treated and 1797 comparator-treated patients with MM as a first line in both transplant-eligible and transplant-ineligible patients and for relapsed/refractory disease. Safety analyses included reporting of AEs using crude and exposure-adjusted incidence rates.
RESULTS


The median follow-up duration was 16.84 months (range, 7.4-28 months) for both daratumumab-treated and comparator-treated patients. Discontinuation for any reason occurred less often with daratumumab (22% vs. 33.9%), although discontinuation because of AEs occurred at similar rates (25% vs. 26%) as did deaths owing to AEs (2.25% vs. 1.84%). When adjusted for exposure, neutropenia, lymphopenia, diarrhea, fatigue, dyspnea, pneumonia, and hypertension were the only common grade 3/4 AEs reported more often with daratumumab than with the comparators. The prevalence of common grade 3/4 AEs with daratumumab were < 7% apart from neutropenia, lymphopenia, and pneumonia (45.9% vs. 32.3%, 13% vs. 7.5%, and 10.6% vs. 7.2%, respectively). Grade 3/4 daratumumab infusion-related reactions happened in 3.8% of patients. The majority of infusion-related reactions occurred after the first infusion.
CONCLUSIONS


These results from an integrated analysis support a favorable benefit/risk profile of daratumumab in patients with MM.",2020,"The prevalence of common grade 3/4 AEs with daratumumab were < 7% apart from neutropenia, lymphopenia, and pneumonia (45.9% vs. 32.3%, 13% vs. 7.5%, and 10.6% vs. 7.2%, respectively).","['patients with MM', 'Data were pooled from 5 completed phase III randomized controlled studies that had included 1798 daratumumab-treated and 1797 comparator-treated patients with MM as a first line in both transplant-eligible and transplant-ineligible patients and for relapsed/refractory disease', 'Patients With Multiple Myeloma']",[],"['exposure, neutropenia, lymphopenia, diarrhea, fatigue, dyspnea, pneumonia, and hypertension', 'reporting of AEs using crude and exposure-adjusted incidence rates', 'neutropenia, lymphopenia, and pneumonia', 'majority of infusion-related reactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",[],"[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.125714,"The prevalence of common grade 3/4 AEs with daratumumab were < 7% apart from neutropenia, lymphopenia, and pneumonia (45.9% vs. 32.3%, 13% vs. 7.5%, and 10.6% vs. 7.2%, respectively).","[{'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Al Hadidi', 'Affiliation': 'Section of Hematology and Oncology, Baylor College of Medicine, Houston, TX. Electronic address: hadidi@bcm.edu.'}, {'ForeName': 'Courtney Nicole', 'Initials': 'CN', 'LastName': 'Miller-Chism', 'Affiliation': 'Section of Hematology and Oncology, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Rammurti', 'Initials': 'R', 'LastName': 'Kamble', 'Affiliation': 'Section of Hematology and Oncology, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Mims', 'Affiliation': 'Section of Hematology and Oncology, Baylor College of Medicine, Houston, TX.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2020.04.004']
827,29924393,What Happens to Nutrition Intake in the Post-Intensive Care Unit Hospitalization Period? An Observational Cohort Study in Critically Ill Adults.,"BACKGROUND


Little is currently known about nutrition intake and energy requirements in the post-intensive care unit (ICU) hospitalization period in critically ill patients. We aimed to describe energy and protein intake, and determine the feasibility of measuring energy expenditure during the post-ICU hospitalization period in critically ill adults.
METHODS


This is a nested cohort study within a randomized controlled trial in critically ill patients. After discharge from ICU, energy and protein intake was quantified periodically and indirect calorimetry attempted. Data are presented as n (%), mean (SD), and median (interquartile range [IQR]).
RESULTS


Thirty-two patients were studied in the post-ICU hospitalization period, and 12 had indirect calorimetry. Mean age and BMI was 56 (18) years and 30 (8) kg/m 2  , respectively, 75% were male, and the median estimated energy and protein requirement were 2000 [1650-2550] kcal and 112 [84-129] g, respectively. Oral nutrition either alone (n = 124 days, 55%) or in combination with enteral nutrition (n = 96 days, 42%) was the predominant mode. Over 227 total days in the post-ICU hospitalization period, a median [IQR] of 1238 [869-1813] kcal and 60 [35-89.5] g of protein was received from nutrition therapy. In the 12 patients who had indirect calorimetry, the median measured daily energy requirement was 1982 [1843-2345] kcal and daily energy deficit was -95 [-1050 to 347] kcal compared with the measured energy requirement.
CONCLUSIONS


Energy and protein intake in the post-ICU hospitalization period was less than estimated and measured energy requirements. Oral nutrition provided alone was the most common mode of nutrition therapy.",2019,"In the 12 patients who had indirect calorimetry, the median measured daily energy requirement was 1982","['12 patients who had indirect calorimetry, the median measured daily energy requirement was 1982', 'Mean age and BMI was 56 (18) years and 30 (8) kg/m 2  , respectively, 75% were male, and the median estimated energy and protein requirement were 2000', 'critically ill adults', 'Thirty-two patients were studied in the post-ICU hospitalization period, and 12 had indirect calorimetry', 'critically ill patients', 'Critically Ill Adults']",[],['daily energy deficit'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006781', 'cui_str': 'Calorimetry, Respiration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0489460', 'cui_str': 'Energy requirement (observable entity)'}, {'cui': 'C0456590', 'cui_str': '1982 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0556043', 'cui_str': 'Protein requirement (observable entity)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",32.0,0.082919,"In the 12 patients who had indirect calorimetry, the median measured daily energy requirement was 1982","[{'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Ridley', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Parke', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Davies', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Hodgson', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Intensive Care Unit, The Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'D James', 'Initials': 'DJ', 'LastName': 'Cooper', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1196']
828,30738698,Verbal learning deficits associated with increased anticholinergic burden are attenuated with targeted cognitive training in treatment refractory schizophrenia patients.,"Targeted cognitive training (TCT) has been reported to improve verbal learning deficits in patients with schizophrenia (SZ). Despite positive findings, it is not clear whether demographic factors and clinical characteristics contribute to the success of TCT on an individual basis. Medication-associated anticholinergic burden has been shown to impact TCT-associated verbal learning gains in SZ outpatients, but the role of anticholinergic medication burden on TCT gains in treatment refractory SZ patients has not been described. In this study, SZ patients mandated to a locked residential rehabilitation center were randomized to treatment as usual (TAU; n=22) or a course of TAU augmented with TCT (n=24). Anticholinergic medication burden was calculated from medication data at baseline and follow-up using the Anticholinergic Cognitive Burden (ACB) Scale. MATRICS Consensus Cognitive Battery Verbal Learning domain scores were used as the primary outcome variable. The TAU and TCT groups were matched in ACB at baseline and follow-up. While baseline ACB was not associated with verbal learning in either group, increases in ACB over the course of the study were significantly associated with deterioration of verbal learning in the TAU group (r=-0.51, p=0.02). This was not seen in subjects randomized to TCT (r=-0.13, p=0.62). Our results suggest that TCT may blunt anticholinergic medication burden associated reduction in verbal learning in severely disabled SZ inpatients.",2019,"This was not seen in subjects randomized to TCT (r=-0.13, p=0.62).","['treatment refractory schizophrenia patients', 'patients mandated to a locked residential rehabilitation center', 'severely disabled SZ inpatients', 'patients with schizophrenia (SZ']","['TCT', 'SZ', 'cognitive training', 'Targeted cognitive training (TCT', 'TAU augmented with TCT']","['Anticholinergic Cognitive Burden (ACB) Scale', 'verbal learning deficits', 'verbal learning', 'deterioration of verbal learning', 'Consensus Cognitive Battery Verbal Learning domain scores', 'Anticholinergic medication burden', 'Verbal learning deficits', 'ACB']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}]","[{'cui': 'C0677634', 'cui_str': 'Reptilase Time'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]","[{'cui': 'C4706338', 'cui_str': 'Anticholinergic Cognitive Burden Scale'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}]",,0.0167648,"This was not seen in subjects randomized to TCT (r=-0.13, p=0.62).","[{'ForeName': 'Yash B', 'Initials': 'YB', 'LastName': 'Joshi', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychology, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Hochberger', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, United States; VISN-22 Mental Illness, Research, Education and Clinical Center (MIRECC), La Jolla, CA, United States.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Bismark', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, United States; VISN-22 Mental Illness, Research, Education and Clinical Center (MIRECC), La Jolla, CA, United States.'}, {'ForeName': 'Emily B H', 'Initials': 'EBH', 'LastName': 'Treichler', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, United States; VISN-22 Mental Illness, Research, Education and Clinical Center (MIRECC), La Jolla, CA, United States.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Molina', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nungaray', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Cardoso', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Sprock', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, United States.'}, {'ForeName': 'Neal R', 'Initials': 'NR', 'LastName': 'Swerdlow', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, United States; VISN-22 Mental Illness, Research, Education and Clinical Center (MIRECC), La Jolla, CA, United States.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Light', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, La Jolla, CA, United States; VISN-22 Mental Illness, Research, Education and Clinical Center (MIRECC), La Jolla, CA, United States. Electronic address: glight@ucsd.edu.'}]",Schizophrenia research,['10.1016/j.schres.2019.01.016']
829,31847914,Evaluation of evening versus morning levothyroxine intake in elderly (MONIALE).,"BACKGROUND


The aging population is associated with increased multimorbidity and polypharmacy. Older adults are at a higher risk of adverse events and reduced therapeutic response. This phenomenon is partially explained by drug interactions and treatment adherence. Most randomized clinical trials have found no significant differences between morning and evening levothyroxine (LT 4 ) administration in young adults, but there is little evidence regarding alternative LT 4  regimens in older populations. Thus, the MONIALE trial aims to test an alternative schedule for LT 4  administration in older adults.
METHODS/DESIGN


This randomized crossover clinical trial will include participants aged 60 years or older with primary hypothyroidism. The trial groups will consist of morning LT 4  intake (60 min before breakfast) or evening LT 4  intake (60 min after supper). The primary outcome will be variation in serum thyrotropin (TSH) levels after 24 weeks of the LT 4  protocol. The secondary outcomes will be the prevalence of drugs that potentially interact with LT 4  and hypothyroidism control according to interaction status. The sample size was calculated to detect a minimum mean difference of 1 mUI/L in serum TSH level between the groups with 80% power and a 5% probability of type I error, resulting in 91 patients per group. The project was approved by the Hospital de Clínicas de Porto Alegre Ethics Committee.
DISCUSSION


Considering the aging population, the increased prevalence of multimorbidity and polypharmacy, as well as potential drug interactions and treatment adherence difficulties, an alternative LT 4  protocol could be useful for hypothyroidism treatment in the elderly. Prior studies comparing alternative LT4 administration protocols have mainly included young adult populations and have not addressed potential drug interactions.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03614988. Registered 30 July 2018.",2019,"Most randomized clinical trials have found no significant differences between morning and evening levothyroxine (LT 4 ) administration in young adults, but there is little evidence regarding alternative LT 4  regimens in older populations.","['young adults', 'elderly (MONIALE', 'participants aged 60\u2009years or older with primary hypothyroidism', 'Older adults', 'older adults']","['levothyroxine', 'evening versus morning levothyroxine']","['prevalence of drugs that potentially interact with LT 4  and hypothyroidism control according to interaction status', 'variation in serum thyrotropin (TSH) levels', 'serum TSH level']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4316995', 'cui_str': 'Primary Hypothyroidism'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2609422', 'cui_str': 'Hypothyroidism (SMQ)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1277938', 'cui_str': 'Serum TSH measurement'}]",91.0,0.21652,"Most randomized clinical trials have found no significant differences between morning and evening levothyroxine (LT 4 ) administration in young adults, but there is little evidence regarding alternative LT 4  regimens in older populations.","[{'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Giassi', 'Affiliation': 'Endocrinology Program, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Piccoli', 'Affiliation': 'Internal Medicine and Geriatric Division, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Ticiana', 'Initials': 'T', 'LastName': 'da Costa Rodrigues', 'Affiliation': 'Endocrinology Program, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Gorga Bandeira de Mello', 'Affiliation': 'Endocrinology Program, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil. rgmello@hcpa.edu.br.'}]",Trials,['10.1186/s13063-019-3816-3']
830,30507280,The Effect of Structured Exercise on Sleep During the Corresponding Night Among Older Women in an Exercise Program.,"This study investigated the acute effect of exercise on sleep outcomes among healthy older women by comparing days with structured exercise versus days without structured exercise during 4 months of exercise training. Participants (n = 51) in this study had wrist-worn actigraphic sleep data available following at least 3 days with structured exercise and 3 days without structured exercise at mid-intervention and at the end of intervention. The exercise intervention was treadmill walking. Multilevel models were used to examine whether structured exercise impacted sleep outcomes during the corresponding night. Overall, 1,362 nights of data were included in the analyses. In unadjusted and adjusted models, bedtimes were significantly earlier on evenings following an acute bout of structured exercise than on evenings without structured exercise. No other sleep parameters differed between exercise and nonexercise days. Understanding the effects of exercise on sleep in this understudied population may help to improve their overall sleep quality.",2019,No other sleep parameters differed between exercise and nonexercise days.,"['healthy older women', 'Older Women in an Exercise Program', 'Participants (n\u2009=\u200951) in this study had wrist-worn actigraphic sleep data available following at least 3 days with']","['structured exercise and 3 days without structured exercise at mid-intervention', 'Structured Exercise', 'exercise intervention was treadmill walking', 'exercise', 'structured exercise versus days without structured exercise during 4 months of exercise training']","['sleep parameters', 'sleep outcomes']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0248954,No other sleep parameters differed between exercise and nonexercise days.,"[{'ForeName': 'Charity B', 'Initials': 'CB', 'LastName': 'Breneman', 'Affiliation': ''}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kline', 'Affiliation': ''}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'West', 'Affiliation': ''}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Sui', 'Affiliation': ''}, {'ForeName': 'Xuewen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2018-0194']
831,24559178,"Dentists United to Extinguish Tobacco (DUET): a study protocol for a cluster randomized, controlled trial for enhancing implementation of clinical practice guidelines for treating tobacco dependence in dental care settings.","BACKGROUND


Although dental care settings provide an exceptional opportunity to reach smokers and provide brief cessation advice and treatment to reduce oral and other tobacco-related health conditions, dental care providers demonstrate limited adherence to evidence-based guidelines for treatment of tobacco use and dependence.
METHODS/DESIGN


Guided by a multi-level, conceptual framework that emphasizes changes in provider beliefs and organizational characteristics as drivers of improvement in tobacco treatment delivery, the current protocol will use a cluster, randomized design and multiple data sources (patient exit interviews, provider surveys, site observations, chart audits, and semi-structured provider interviews) to study the process of implementing clinical practice guidelines for treating tobacco dependence in 18 public dental care clinics in New York City. The specific aims of this comparative-effectiveness research trial are to: compare the effectiveness of three promising strategies for implementation of tobacco use treatment guidelines-staff training and current best practices (CBP), CBP + provider performance feedback (PF), and CBP + PF + provider reimbursement for delivery of tobacco cessation treatment (pay-for-performance, or P4P); examine potential theory-driven mechanisms hypothesized to explain the comparative effectiveness of three strategies for implementation; and identify baseline organizational factors that influence the implementation of evidence-based tobacco use treatment practices in dental clinics. The primary outcome is change in providers' tobacco treatment practices and the secondary outcomes are cost per quit, use of tobacco cessation treatments, quit attempts, and smoking abstinence.
DISCUSSION


We hypothesize that the value of these promising implementation strategies is additive and that incorporating all three strategies (CBP, PF, and P4P) will be superior to CBP alone and CBP + PF in improving delivery of cessation assistance to smokers. The findings will improve knowledge pertinent to the implementation, dissemination, and sustained utilization of evidence-based tobacco use treatment in dental practices.
TRIAL REGISTRATION


NCT01615237.",2014,"The primary outcome is change in providers' tobacco treatment practices and the secondary outcomes are cost per quit, use of tobacco cessation treatments, quit attempts, and smoking abstinence.
","['18 public dental care clinics in New York City', 'dental clinics']",[],"[""change in providers' tobacco treatment practices and the secondary outcomes are cost per quit, use of tobacco cessation treatments, quit attempts, and smoking abstinence""]","[{'cui': 'C0011331', 'cui_str': 'Dental Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}]",[],"[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0600549', 'cui_str': 'Tobacco Cessation'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",18.0,0.168005,"The primary outcome is change in providers' tobacco treatment practices and the secondary outcomes are cost per quit, use of tobacco cessation treatments, quit attempts, and smoking abstinence.
","[{'ForeName': 'Jamie S', 'Initials': 'JS', 'LastName': 'Ostroff', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10022, USA. ostroffj@mskcc.org.'}, {'ForeName': 'Yuelin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Donna R', 'Initials': 'DR', 'LastName': 'Shelley', 'Affiliation': ''}]",Implementation science : IS,['10.1186/1748-5908-9-25']
832,31658975,Redefining Hypoglycemia in Clinical Trials: Validation of Definitions Recently Adopted by the American Diabetes Association/European Association for the Study of Diabetes.,"OBJECTIVE


To determine if the International Hypoglycaemia Study Group (IHSG) level 2 low glucose definition can identify clinically relevant hypoglycemia in clinical trials and offer value as an end point for future trials.
RESEARCH DESIGN AND METHODS


A post hoc analysis was performed of the SWITCH (SWITCH 1:  n  = 501, type 1 diabetes; SWITCH 2:  n  = 721, type 2 diabetes) and DEVOTE ( n  = 7,637, type 2 diabetes) trials utilizing the IHSG low glucose definitions. Patients in all trials were randomized to either insulin degludec or insulin glargine 100 units/mL. In the main analysis, the following definitions were compared:  1 ) American Diabetes Association (ADA) 2005 (plasma glucose [PG] confirmed ≤3.9 mmol/L with symptoms); and  2 ) IHSG level 2 (PG confirmed <3.0 mmol/L, independent of symptoms).
RESULTS


In SWITCH 2, the estimated rate ratios of hypoglycemic events indicated increasing differences between treatments with decreasing PG levels until 3.0 mmol/L, following which no additional treatment differences were observed. Similar results were observed for the SWITCH 1 trial. In SWITCH 2, the IHSG level 2 definition produced a rate ratio that was lower than the ADA 2005 definition.
CONCLUSIONS


The IHSG level 2 definition was validated in a series of clinical trials, demonstrating its ability to discriminate between basal insulins. This definition is therefore recommended to be uniformly adopted by regulatory bodies and used in future clinical trials.",2020,"In SWITCH 2, the estimated rate ratios of hypoglycemic events indicated increasing differences between treatments with decreasing PG levels until 3.0 mmol/L, following which no additional treatment differences were observed.",[],"['IHSG low glucose definitions', 'insulin degludec or insulin glargine 100 units/mL', 'Insulin Degludec versus Insulin Glargine']","['rate ratio', 'IHSG level 2 (glucose', 'rate ratios of hypoglycemic events']",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0456948', 'cui_str': 'Level 2 (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",2005.0,0.0568146,"In SWITCH 2, the estimated rate ratios of hypoglycemic events indicated increasing differences between treatments with decreasing PG levels until 3.0 mmol/L, following which no additional treatment differences were observed.","[{'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Heller', 'Affiliation': 'Academic Unit of Diabetes, Oncology & Metabolism, University of Sheffield, Sheffield, U.K. s.heller@sheffield.ac.uk.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ratner', 'Affiliation': 'Division of Endocrinology and Metabolism, Georgetown University Medical School, Washington, DC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Seaquist', 'Affiliation': 'Department of Medicine, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bardtrum', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Charlotte Thim', 'Initials': 'CT', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Tutkunkardas', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Alan C', 'Initials': 'AC', 'LastName': 'Moses', 'Affiliation': 'Novo Nordisk Inc., Plainsboro, NJ.'}]",Diabetes care,['10.2337/dc18-2361']
833,30366687,Prospective Trial of Low-Fidelity Deliberate Practice of Aortic and Coronary Anastomoses (TECoG 002).,"OBJECTIVE


We sought to examine the feasibility of a home practice curriculum of vascular anastomosis in cardiovascular surgery using a low-fidelity simulation platform and to examine its effectiveness in skill acquisition in senior surgical trainees.
DESIGN


We organized a multicenter prospective randomized study of senior residents and fellows, who were oriented to a low-fidelity cardiac simulator and an 8-week curriculum of independent practice of aortic and coronary anastomosis. ""Treatment"" trainees received a simulator and the curriculum. Control trainees received only their usual operative experience. The groups then crossed over; all were studied for 16 weeks in total. Video skill assessments were captured at 0, 8, and 16 weeks and were scored by one blinded investigator using the Joint Council on Thoracic Surgery Education Assessment tool. A post-hoc survey was distributed to invited participants following study completion.
SETTING


University of Minnesota Department of Surgery, Mayo Clinic Department of Cardiovascular Surgery, and the University of Texas Health Science Center at Houston. Participants used the simulator in offices, call rooms, and their homes.
PARTICIPANTS


Program participation in the study was solicited through the Thoracic Education Cooperative Group. Four institutions expressed interest and a total of 29 trainees were invited to the study and randomized. Of these, 12 (38%) completed the curriculum and submitted the requisite 3 sets of videos (6 treatment, 6 control). All were senior residents and fellows in general and cardiothoracic surgery.
RESULTS


No significant differences were detected in assessment scores before and after the curriculum nor before or after the control period in the overall or postgraduate year-stratified populations. Participant case numbers during the study did not have a significant effect on assessment scores. Randomized participants reported strong interest in deliberate practice of technical skills but identified competing clinical and personal obligations and significant barriers to simulation.
CONCLUSIONS


Considerable variability in performance existed among participants who completed the study, but overall, the curriculum alone was insufficient to improve simulator Joint Council on Thoracic Surgery Education scores compared to those not undergoing the curriculum. Among senior residents and fellows, provision of a practice curriculum and simulator for repeated practice is feasible but clinical and personal responsibilities were barriers to repetitive practice.",2019,No significant differences were detected in assessment scores before and after the curriculum nor before or after the control period in the overall or postgraduate year-stratified populations.,"['senior surgical trainees', 'Program participation in the study was solicited through the Thoracic Education Cooperative Group', 'Participants used the simulator in offices, call rooms, and their homes', 'Four institutions expressed interest and a total of 29 trainees', 'University of Minnesota Department of Surgery, Mayo Clinic Department of Cardiovascular Surgery, and the University of Texas Health Science Center at Houston', 'senior residents and fellows, who were oriented to a low-fidelity cardiac simulator and an 8-week curriculum of independent practice of aortic and coronary anastomosis. ']",[],"['Thoracic Surgery Education scores', 'Video skill assessments']","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}]",[],"[{'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",29.0,0.0596719,No significant differences were detected in assessment scores before and after the curriculum nor before or after the control period in the overall or postgraduate year-stratified populations.,"[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Spratt', 'Affiliation': 'Department of Surgery, University of Minnesota, Minneapolis, Minnesota. Electronic address: sprat020@umn.edu.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Brunsvold', 'Affiliation': 'Division of Critical Care/Acute Care Surgery, Department of Surgery, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Joyce', 'Affiliation': 'Division of Cardiothoracic Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, University of Texas Health Science Center at Houston, Houston, Texas.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Antonoff', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Loor', 'Affiliation': 'Division of Cardiothoracic Surgery, Department of Surgery, University of Minnesota, Minneapolis, Minnesota.'}]",Journal of surgical education,['10.1016/j.jsurg.2018.09.007']
834,30287671,"Glimepiride monotherapy versus combination of glimepiride and linagliptin therapy in patients with HNF1A-diabetes: a protocol for a randomised, double-blinded, placebo-controlled trial.","INTRODUCTION


Hepatocyte nuclear factor 1α (HNF1A)-diabetes is the most common monogenetic subtype of diabetes. Strict glycaemic control is crucial for a good prognosis for patients with HNF1A-diabetes. Sulfonylurea (SU) is used as a first-line therapy in HNF1A-diabetes. However, SU therapy may be problematic as it confers a high risk of hypoglycaemia. We hypothesise that low dose of SU in combination with a dipeptidyl peptidase 4 inhibitor provides a safer and more efficacious treatment in patients with HNF1A-diabetes compared with SU as monotherapy.
METHODS AND ANALYSIS


In a randomised, double-blinded, crossover study, patients with HNF1A-diabetes will randomly be assigned to 16 weeks of treatment with glimepiride+linagliptin, 4 weeks of washout and 16 weeks of treatment with glimepiride+placebo (or vice versa). Treatment will be evaluated with continuous glucose monitoring and combined meal and bicycle tests conducted at baseline and at the end of each of the two treatment periods. The primary end point is the absolute difference in the mean amplitude of glycaemic excursions between the two treatments (glimepiride+linagliptin vs glimepiride+placebo) at the end of each treatment period.
ETHICS AND DISSEMINATION


The study protocol is approved by the Danish Medicines Agency, The Scientific-Ethical Committee of the Capital Region of Denmark (H-17014518) and the Danish Data Protection Agency. The trial will be carried out and monitored in compliance with Good Clinical Practice guidelines and in accordance with the latest version of the Declaration of Helsinki. Positive, negative and inconclusive results will be published at scientific conferences and as one or more scientific manuscripts in peer-reviewed journals with authorship in accordance with the International Committee of Medical Journal Editors' recommendations.
TRIAL REGISTRATION NUMBER


2017-000204-15.",2018,"The primary end point is the absolute difference in the mean amplitude of glycaemic excursions between the two treatments (glimepiride+linagliptin vs glimepiride+placebo) at the end of each treatment period.
","['HNF1A-diabetes', 'patients with HNF1A-diabetes']","['placebo', 'Sulfonylurea (SU', 'glimepiride+linagliptin', 'glimepiride+placebo', 'Glimepiride monotherapy', 'SU therapy', 'glimepiride and linagliptin therapy']",['mean amplitude of glycaemic excursions'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.178343,"The primary end point is the absolute difference in the mean amplitude of glycaemic excursions between the two treatments (glimepiride+linagliptin vs glimepiride+placebo) at the end of each treatment period.
","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sidelmann Christensen', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Storgaard', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Hædersdal', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Clinical Metabolic Physiology, Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}]",BMJ open,['10.1136/bmjopen-2018-022517']
835,31620393,Efficacy of biofeedback therapy for objective improvement of pelvic function in low anterior resection syndrome.,"Purpose


There is no established treatment of choice for low anterior resection syndrome (LARS). To evaluate the efficacy of biofeedback therapy for objective improvement of pelvic function in LARS, we performed the present study.
Methods


The primary endpoint was the change of Wexner score. Consenting patients between 20 and 80 years old with major LARS at least 2 months after sphincter preserving proctectomy for rectal cancer were enrolled. After recommendation of biofeedback therapy, patients who accept it were enrolled in the biofeedback group and patients who refuse were enrolled in the control group. Initial and follow-up evaluations were performed and analyzed.
Results


Fifteen and sixteen patients were evaluated in the control group and the biofeedback group, respectively. There was no statistically significant difference of LARS score between both groups. Decrease in Wexner score and increase in rectal capacity were significantly higher in the biofeedback group (odds ratio [OR], 5.386; 95% confidence interval [CI], 1.194-24.287; P = 0.028 and OR, 1.061; 95% CI, 1.002-1.123; P = 0.042).
Conclusion


Biofeedback therapy was superior for objective improvement of pelvic function to observation in LARS. It can be considered to induce more rapid improvement of major LARS.",2019,"Decrease in Wexner score and increase in rectal capacity were significantly higher in the biofeedback group (odds ratio [OR], 5.386; 95% confidence interval [CI], 1.194-24.287; P = 0.028 and OR, 1.061; 95% CI, 1.002-1.123; P = 0.042).
","['patients who accept it were enrolled in the biofeedback group and patients who refuse were enrolled in the control group', 'Consenting patients between 20 and 80 years old with major LARS at least 2 months after sphincter preserving proctectomy for rectal cancer were enrolled', 'low anterior resection syndrome']",['biofeedback therapy'],"['pelvic function', 'LARS score', 'Wexner score and increase in rectal capacity', 'change of Wexner score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0193062', 'cui_str': 'Rectum Resection'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C4524073', 'cui_str': 'Low anterior resection syndrome'}]","[{'cui': 'C0005491', 'cui_str': 'Feedback, Psychophysiologic'}]","[{'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",31.0,0.0313799,"Decrease in Wexner score and increase in rectal capacity were significantly higher in the biofeedback group (odds ratio [OR], 5.386; 95% confidence interval [CI], 1.194-24.287; P = 0.028 and OR, 1.061; 95% CI, 1.002-1.123; P = 0.042).
","[{'ForeName': 'Kyung Ha', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Chungnam National University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Jin Soo', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chungnam National University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chungnam National University College of Medicine, Daejeon, Korea.'}]",Annals of surgical treatment and research,['10.4174/astr.2019.97.4.194']
836,31650079,Virtual reality for pain management in patients with heart failure: Study rationale and design.,"Background


Patients with advanced heart failure commonly experience acute and/or chronic moderate to severe pain related to disease, treatment, or both. While pain management strategies typically focus on drug therapies, non-pharmacological interventions may prove beneficial without risk of significant clinical side effects or contraindications. One novel strategy, virtual reality, has been shown to improve pain control in addition to usual pharmacological interventions.
Methods


This is a prospective, two-armed, single center randomized controlled pilot study of a virtual reality intervention in 128 hospitalized subjects with ACC/AHA stage C or stage D heart failure who self-report pain rated 4/10 or greater compared to an active control, two-dimensional guided imagery. The primary outcome is change in self-reported pain score measured by the Brief Pain Inventory (Short Form). Secondary end points include changes in self-reported distress, quality of life, and satisfaction with pain management.
Conclusion


This randomized controlled study aims to provide empiric data to support application and expansion of novel technologies such as virtual reality to augment usual pharmacological pain management strategies in hospitalized patients with heart failure.",2019,"Secondary end points include changes in self-reported distress, quality of life, and satisfaction with pain management.
","['hospitalized patients with heart failure', '\n\n\nPatients with advanced heart failure commonly experience acute and/or chronic moderate to severe pain', 'patients with heart failure', '128 hospitalized subjects with ACC/AHA stage C or stage D heart failure who self-report pain rated 4/10 or greater compared to an active control, two-dimensional guided imagery']","['virtual reality intervention', 'Virtual reality']","['change in self-reported pain score measured by the Brief Pain Inventory (Short Form', 'changes in self-reported distress, quality of life, and satisfaction with pain management']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441785', 'cui_str': 'Stage C (qualifier value)'}, {'cui': 'C0441789', 'cui_str': 'Stage D (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}]",128.0,0.0891843,"Secondary end points include changes in self-reported distress, quality of life, and satisfaction with pain management.
","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Stewart', 'Affiliation': 'Section of Palliative Care, MedStar Washington Hospital Center, Washington DC, USA.'}, {'ForeName': 'Mihriye', 'Initials': 'M', 'LastName': 'Mete', 'Affiliation': 'MedStar Health Research Institute, Hyattsville, MD, USA.'}, {'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'Groninger', 'Affiliation': 'Section of Palliative Care, MedStar Washington Hospital Center, Washington DC, USA.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2019.100470']
837,32409277,Community perspectives on difference of sex development (DSD) diagnoses: A crowdsourced survey.,"INTRODUCTION AND OBJECTIVES


Differences of sex development (DSD) engender ethical, social and psychosexual complexities that can complicate medical decision-making. We performed a web-based pilot study to estimate the utility value of a DSD diagnosis and to identify community concerns regarding DSD management.
METHODS


A cross-sectional survey was posted on Amazon's Mechanical Turk, an online crowdsourcing platform. Respondents were ≥18y and were randomized to receive information on one of three common DSD conditions: Congenital Adrenal Hyperplasia (CAH), Mixed Gonadal Dysgenesis (MGD), and Partial Androgen Insensitivity Syndrome (PAIS). Time trade-off methodology was used to estimate utility values. Likert scale and statement-ranking questions were used to assess respondent perceptions.
RESULTS


Of 1,628 respondents, median age was 34y; most respondents were parents (59.1%), white (77.1%), and previously unfamiliar with DSD (60.4%). The median overall utility value was 0.70 (IQR 0.50-0.90), similar to moderately severe chronic health conditions. Utility estimates varied based on the DSD scenario presented (0.80 CAH vs. 0.70 MGD vs. 0.80 PAIS, p = 0.0006), respondent gender (p < 0.0001), race (p = 0.002), religion (p = 0.005), and prior knowledge of DSD (p < 0.0001). Reported concerns included gender identity (23.4%), urinary function (20.5%) and surgical complications (17.4%). Most (67.5%) supported early surgical intervention at 6-18 mo; 10.4% thought surgery should occur ≥18 y.
COMMENT


Limitations of this study include that survey participants were aware of the nature of the study, thus some respondents may have participated to skew the results. Given the nature of this pilot study, the representation of families with children with DSD within the study is severely limited given the rarity of DSDs. This means that their opinions may be diluted by the large sample size. However, because utility values are classically estimated according to community opinions, the utility data presented should be taken to reflect that of the specific sample studied and is not reflective of that of families with a vested interest in such cases.
CONCLUSIONS


Community-based respondents perceived that DSD conditions were associated with a reduction in utility values (0.70-0.80), on par with moderately severe chronic health conditions. Estimates varied based on respondents' gender, race, religion and prior knowledge of DSD. Gender identity was the most concerning aspect for respondents.",2020,"Most (67.5%) supported early surgical intervention at 6-18 mo; 10.4% thought surgery should occur ≥18 y.
COMMENT


Limitations of this study include that survey participants were aware of the nature of the study, thus some respondents may have participated to skew the results.","[""A cross-sectional survey was posted on Amazon's Mechanical Turk, an online crowdsourcing platform"", 'families with children with DSD', '1,628 respondents']","['DSD conditions: Congenital Adrenal Hyperplasia (CAH), Mixed Gonadal Dysgenesis (MGD), and Partial Androgen Insensitivity Syndrome (PAIS']","['urinary function', 'median overall utility value', 'utility values', 'surgical complications']","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}, {'cui': 'C3494386', 'cui_str': 'Crowd Sourcing'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2930619', 'cui_str': 'Disorder of sexual differentiation'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}]","[{'cui': 'C2930619', 'cui_str': 'Disorder of sexual differentiation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001627', 'cui_str': 'Congenital adrenal hyperplasia'}, {'cui': 'C0018055', 'cui_str': 'Mixed gonadal dysgenesis'}, {'cui': 'C0268301', 'cui_str': 'Reifenstein syndrome'}]","[{'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0455143,"Most (67.5%) supported early surgical intervention at 6-18 mo; 10.4% thought surgery should occur ≥18 y.
COMMENT


Limitations of this study include that survey participants were aware of the nature of the study, thus some respondents may have participated to skew the results.","[{'ForeName': 'M Hassan', 'Initials': 'MH', 'LastName': 'Alkazemi', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Ashley W', 'Initials': 'AW', 'LastName': 'Johnston', 'Affiliation': 'Department of Surgery, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Meglin', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Deanna', 'Initials': 'D', 'LastName': 'Adkins', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Routh', 'Affiliation': 'Department of Surgery, Duke University School of Medicine, Durham, NC, USA. Electronic address: jonathan.routh@duke.edu.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.03.023']
838,29995670,"Preventing Exercise-Associated Collapse Using Online Runner Education: A Randomized, Controlled Trial.","OBJECTIVE


To determine whether online exercise-associated collapse (EAC) prevention education decreases medical tent EAC visits among first-time marathoners.
DESIGN


A prospective controlled study, with age- and sex-stratified randomization, evaluated rates of medical tent diagnosed EAC among runners randomized to the intervention group and intervention participants, compared with a control group.
SETTING


Grandma's Marathon Medical Tent in Duluth, MN, June 2016.
PARTICIPANTS


Runners in the 2016 Grandma's Marathon who never previously ran a marathon (n = 2943), randomized into control (n = 1482) and intervention (n = 1461) groups. Intervention participants opened the EAC prevention video (n = 590).
INTERVENTIONS


Online EAC education included an introductory webpage and 5-minute professional video describing EAC and prevention.
MAIN OUTCOME MEASURES


Medical tent visit with EAC diagnosis.
RESULTS


Intervention participants had no decreased likelihood of EAC, compared with controls [odds ratio (OR), 0.88, 95% confidence interval (CI), 0.46-1.69]. Exercise-associated collapse occurred less frequently in those with longer race times (OR, 0.58, 95% CI, 0.43-0.79). Intervention participation was associated with longer race times (OR, 1.12, 95% CI, 1.10-1.23).
CONCLUSIONS


Those opening the EAC prevention video and controls had similar EAC rates. Slower running speed was associated with lower EAC rates. Video viewing was a predictor of slower running pace.",2020,"Intervention participation was associated with longer race times (OR, 1.12, 95% CI, 1.10-1.23).
","[""Grandma's Marathon Medical Tent in Duluth, MN, June 2016"", ""Runners in the 2016 Grandma's Marathon who never previously ran a marathon (n = 2943), randomized into control (n = 1482) and intervention (n = 1461) groups""]","['control group', 'Exercise-Associated Collapse Using Online Runner Education', 'EAC prevention video', 'online exercise-associated collapse (EAC) prevention education', 'Online EAC education included an introductory webpage and 5-minute professional video describing EAC and prevention']","['longer race times', 'likelihood of EAC', 'EAC rates', 'Exercise-associated collapse']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0677506', 'cui_str': 'Tent, device (physical object)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392748', 'cui_str': 'Collapsed (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1633748', 'cui_str': 'Prevention education'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0392748', 'cui_str': 'Collapsed (qualifier value)'}]",2943.0,0.0912051,"Intervention participation was associated with longer race times (OR, 1.12, 95% CI, 1.10-1.23).
","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Worley', 'Affiliation': 'Health Services, University of Minnesota Duluth, Duluth, MN.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Renier', 'Affiliation': 'Essentia Institute of Rural Health, Duluth, MN.'}, {'ForeName': 'Theo A', 'Initials': 'TA', 'LastName': 'Woehrle', 'Affiliation': 'Essentia Institute of Rural Health, Duluth, MN.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Stovitz', 'Affiliation': 'Department of Family Medicine and Community Health, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Nelson', 'Affiliation': 'Department of Orthopedics and Sports Medicine, Essentia Health-Duluth Clinic, Duluth, MN.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000607']
839,30281320,Bivalirudin versus heparin monotherapy in non-ST-segment elevation myocardial infarction.,"BACKGROUND


The optimal anti-coagulation strategy for patients with non-ST-elevation myocardial infarction treated with percutaneous coronary intervention is unclear in contemporary clinical practice of radial access and potent P2Y12-inhibitors. The aim of this study was to investigate whether bivalirudin was superior to heparin monotherapy in patients with non-ST-elevation myocardial infarction without routine glycoprotein IIb/IIIa inhibitor use.
METHODS


In a large pre-specified subgroup of the multicentre, prospective, randomised, registry-based, open-label clinical VALIDATE-SWEDEHEART trial we randomised patients with non-ST-elevation myocardial infarction undergoing percutaneous coronary intervention, treated with ticagrelor or prasugrel, to bivalirudin or heparin monotherapy with no planned use of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention. The primary endpoint was the rate of a composite of all-cause death, myocardial infarction or major bleeding within 180 days.
RESULTS


A total of 3001 patients with non-ST-elevation myocardial infarction, were enrolled. The primary endpoint occurred in 12.1% (182 of 1503) and 12.5% (187 of 1498) of patients in the bivalirudin and heparin groups, respectively (hazard ratio of bivalirudin compared to heparin treatment 0.96, 95% confidence interval 0.78-1.18,  p =0.69). The results were consistent in all major subgroups. All-cause death occurred in 2.0% versus 1.7% (hazard ratio 1.15, 0.68-1.94,  p =0.61), myocardial infarction in 2.3% versus 2.5% (hazard ratio 0.91, 0.58-1.45,  p =0.70), major bleeding in 8.9% versus 9.1% (hazard ratio 0.97, 0.77-1.24,  p =0.82) and definite stent thrombosis in 0.3% versus 0.2% (hazard ratio 1.33, 0.30-5.93,  p =0.82).
CONCLUSION


Bivalirudin as compared to heparin during percutaneous coronary intervention for non-ST-elevation myocardial infarction did not reduce the composite of all-cause death, myocardial infarction or major bleeding in non-ST-elevation myocardial infarction patients receiving current recommended treatments with modern P2Y12-inhibitors and predominantly radial access.",2019,"The primary endpoint was the rate of a composite of all-cause death, myocardial infarction or major bleeding within 180 days.
","['3001 patients with non-ST-elevation myocardial infarction, were enrolled', 'patients with non-ST-elevation myocardial infarction without routine glycoprotein IIb/IIIa inhibitor use', 'patients with non-ST-elevation myocardial infarction undergoing percutaneous coronary intervention, treated with', 'non-ST-segment elevation myocardial infarction', 'patients with non-ST-elevation myocardial infarction treated with']","['percutaneous coronary intervention', 'heparin', 'Bivalirudin', 'bivalirudin', 'heparin monotherapy', 'ticagrelor or prasugrel, to bivalirudin or heparin monotherapy with no planned use of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention']","['rate of a composite of all-cause death, myocardial infarction or major bleeding within 180 days', 'major bleeding', 'definite stent thrombosis', 'myocardial infarction', 'All-cause death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4255010', 'cui_str': 'Non-ST-Elevation Myocardial Infarction'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0168273', 'cui_str': 'bivalirudin'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",3001.0,0.0946849,"The primary endpoint was the rate of a composite of all-cause death, myocardial infarction or major bleeding within 180 days.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Cardiology, Lund University, Sweden.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Koul', 'Affiliation': 'Department of Cardiology, Lund University, Sweden.'}, {'ForeName': 'Elmir', 'Initials': 'E', 'LastName': 'Omerovic', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Fröbert', 'Affiliation': 'Department of Cardiology, Örebro University, Sweden.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Linder', 'Affiliation': 'Department of Cardiology, Danderyd Hospital, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Danielewicz', 'Affiliation': 'PCI-Unit, Karlstad Hospital, Sweden.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Hamid', 'Affiliation': 'Department of Cardiology, Mälarsjukhuset, Sweden.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Venetsanos', 'Affiliation': 'Department of Cardiology, Karolinska University Hospital, Sweden.'}, {'ForeName': 'Loghman', 'Initials': 'L', 'LastName': 'Henareh', 'Affiliation': 'Department of Cardiology, Karolinska University Hospital, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Pettersson', 'Affiliation': 'Department of Cardiology, Umeå University, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Department of Cardiology, Helsingborg Lasarett, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Grimfjärd', 'Affiliation': 'Department of Internal Medicine, Västmanlands Sjukhus, Sweden.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Capio S:t Görans Hospital AB, Sweden.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Hofmann', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ulvenstam', 'Affiliation': 'Department of Cardiology, Östersund Hospital, Sweden.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Völz', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'Petur', 'Initials': 'P', 'LastName': 'Petursson', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Sweden.'}, {'ForeName': 'Ollie', 'Initials': 'O', 'LastName': 'Östlund', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Sweden.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Sarno', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Scherstén', 'Affiliation': 'Department of Cardiology, Lund University, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Eriksson', 'Affiliation': 'Department of Cardiology, Umeå University, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Sweden.'}]",European heart journal. Acute cardiovascular care,['10.1177/2048872618805663']
840,30110179,Harsh Parenting and Violence Against Children: A Trial with Ultrapoor Families in Francophone West Africa.,"Few culturally congruent interventions are available to reduce abusive practices in families living in abject poverty in francophone West Africa. This study tests the effects of economic intervention-alone and in combination with a family-focused component-on parenting outcomes and children's reports of violence in rural Burkina Faso. Female caregivers and their 10- to 15-year-old children from 360 ultrapoor families were recruited to participate in a parallel cluster randomized control trial with 3 study arms: the waitlist (control) group, the economic intervention group (Trickle Up [TU]), and the economic intervention plus family coaching group (TU+). Effects were tested using repeated-measures mixed-effects regressions. At 12 months from baseline, caregivers from the TU+ group reported a reduced use of harsh discipline compared to the control group (Cohen's  d  = -0.57,  p  = .001) and the TU group ( d  = -0.48,  p  = .001). Changes were maintained at 24 months. TU+ caregivers also expressed more supportive parenting attitudes at 12 months compared to the control group ( d  = 0.39,  p  = .022) and the TU group ( d  = 0.55,  p  = .001). Compared to TU caregivers, caregivers in the TU+ group also reported a better quality of child-parent relationship ( d  = 0.40,  p  = .041). At 24 months, children in the TU+ group had lower odds of experiencing physical (odds ratio = 0.35,  p  = .050), 95% confidence interval [0.12, 1.00], and emotional (odds ratio = 0.52,  p  = .033), 95% confidence interval [0.28, 0.95], violence at home, compared to the control group children. The evidence suggests that involving all family members in sessions on child protection in addition to economic strengthening strategies can foster supportive parenting environments and reduce family violence among children living in ultralevel poverty in West Africa.",2020,"At 12 months from baseline, caregivers from the TU+ group reported a reduced use of harsh discipline compared to the control group (Cohen's d = -0.57, p = .001) and the TU group (d = -0.48, p = .001).","[""children's reports of violence in rural Burkina Faso"", 'children living in ultralevel poverty in West Africa', 'Harsh Parenting and Violence Against Children', 'Female caregivers and their 10- to 15-year-old children from 360 ultrapoor families']","['economic intervention plus family coaching group (TU', 'economic intervention group', 'economic intervention-alone and in combination with a family-focused component']","['quality of child-parent relationship', 'experiencing physical', 'reduced use of harsh discipline', 'supportive parenting attitudes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0006409', 'cui_str': 'Upper Volta'}, {'cui': 'C0032854', 'cui_str': 'Poverty'}, {'cui': 'C0001747', 'cui_str': 'West Africa'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",360.0,0.0516571,"At 12 months from baseline, caregivers from the TU+ group reported a reduced use of harsh discipline compared to the control group (Cohen's d = -0.57, p = .001) and the TU group (d = -0.48, p = .001).","[{'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Ismayilova', 'Affiliation': 'School of Social Service Administration, University of Chicago.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Karimli', 'Affiliation': 'Luskin School of Public Affairs, University of California Los Angeles.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2018.1485103']
841,30054636,Association of Circulating Tumor Cells With Late Recurrence of Estrogen Receptor-Positive Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Late recurrence 5 or more years after diagnosis accounts for at least one-half of all cases of recurrent hormone receptor-positive breast cancer.
Objective


To determine whether the presence of circulating tumor cells (CTCs) in a peripheral blood sample obtained approximately 5 years after diagnosis was associated with late clinical recurrence of operable human epidermal growth factor receptor 2-negative breast cancer.
Design, Setting, and Participants


This per-protocol secondary analysis of the Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab or Placebo in Patients With Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer enrolled patients from 2007 to 2011 who were without clinical evidence of recurrence between 4.5 and 7.5 years after primary surgical treatment of human epidermal growth factor receptor 2-negative stage II-III breast cancer followed by adjuvant systemic therapy. Patients were enrolled in a subprotocol for secondary analysis from February 25, 2013, to July 29, 2016, after signing consent for the subprotocol. The analysis was performed in April 2018.
Interventions


A blood sample was obtained for identification and enumeration of CTCs.
Main Outcome and Measures


The association between a positive CTC assay result (at least 1 CTC per 7.5 mL of blood) and clinical recurrence.
Results


Among 547 women included in this analysis, the results of the CTC assay were positive for 18 of 353 with hormone receptor-positive disease (5.1% [95% CI, 3.0%-7.9%]); 23 of 353 patients (6.5% [95% CI, 4.2%-9.6%]) had a clinical recurrence. The recurrence rates per person-year of follow-up in the CTC-positive and CTC-negative groups were 21.4% (7 recurrences per 32.7 person-years) and 2.0% (16 recurrences per 796.3 person-years), respectively. In multivariate models including clinical covariates, a positive CTC assay result was associated with a 13.1-fold higher risk of recurrence (hazard ratio point estimate, 13.1; 95% CI, 4.7-36.3). Seven of 23 patients (30.4% [95% CI, 13.2%-52.9%]) with recurrence had a positive CTC assay result at a median of 2.8 years (range, 0.1-2.8 years) before clinical recurrence. The CTC assay result was also positive for 8 of 193 patients (4.1% [95% CI, 1.8%-8.0%]) with hormone receptor-negative disease, although only 1 patient (0.5% [95% CI, 0%-2.9%]) experienced disease recurrence (this patient was CTC negative).
Conclusions and Relevance


A single positive CTC assay result 5 years after diagnosis of hormone receptor-positive breast cancer provided independent prognostic information for late clinical recurrence, which provides proof of concept that liquid-based biomarkers may be used to risk stratify for late recurrence and guide therapy.
Trial Registration


ClinicalTrials.gov identifier: NCT00433511.",2018,"The CTC assay result was also positive for 8 of 193 patients (4.1% [95% CI, 1.8%-8.0%]) with hormone receptor-negative disease, although only 1 patient (0.5% [95% CI, 0%-2.9%]) experienced disease recurrence (this patient was CTC negative).
","['Patients were enrolled in a subprotocol for secondary analysis from February 25, 2013, to July 29, 2016, after signing consent for the subprotocol', 'Patients With Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer enrolled patients from 2007 to 2011 who were without clinical evidence of recurrence between 4.5 and 7.5 years after primary surgical treatment of human epidermal growth factor receptor 2-negative stage II-III breast cancer followed by adjuvant systemic therapy', 'Estrogen Receptor-Positive Breast Cancer', '547 women']",['Doxorubicin and Cyclophosphamide Followed by Paclitaxel With Bevacizumab or Placebo'],"['clinical recurrence', 'Late recurrence', 'disease recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C2938924', 'cui_str': 'Oestrogen receptor positive breast cancer'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}]",547.0,0.196745,"The CTC assay result was also positive for 8 of 193 patients (4.1% [95% CI, 1.8%-8.0%]) with hormone receptor-negative disease, although only 1 patient (0.5% [95% CI, 0%-2.9%]) experienced disease recurrence (this patient was CTC negative).
","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Sparano', 'Affiliation': 'Department of Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""O'Neill"", 'Affiliation': 'Department of Biostatistics & Computational Biology, Dana Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Alpaugh', 'Affiliation': 'Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Department of Oncology, Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland.'}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Northfelt', 'Affiliation': 'Department of Internal Medicine, Division of Hematology/Oncology, Mayo Clinic, Scottsdale, Arizona.'}, {'ForeName': 'Chau T', 'Initials': 'CT', 'LastName': 'Dang', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Sledge', 'Affiliation': 'Department of Medicine, Division of Oncology, Stanford Cancer Center, Palo Alto, California.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, Indiana University Melvin and Bren Simon Cancer Center, Indianapolis.'}]",JAMA oncology,['10.1001/jamaoncol.2018.2574']
842,29973117,Comparison of Interactive Education Versus Fluorescent Concretization on Hand Hygiene Compliance Among Primary School Students: A Randomized Controlled Trial.,"Hand hygiene for children is crucial to keep them healthy. The purpose of the study was to evaluate the effects of two educational initiatives on ""handwashing effectiveness (HWE)."" A randomized controlled trial was carried out during April/June 2016, and 96 primary school students were randomly assigned to Group I receiving education with fluorescent gel; Group II receiving interactive education or control group continuing its normal education. Evaluation was made by scoring the fluorescent areas on the hands with photographs. There were significant differences in handwashing scores between preprogram and postprogram for all areas in only Group II ( p  < .05). HWE increased from 17.9% to 18.4% in Group I, from 15.4% to 37.7% in Group II, and from 35.5% to 35.8% in control group. Only concretization with fluorescent gel is not a sufficiently strong motivator for increasing HWE. New techniques should be integrated into the training programs for children.",2019,There were significant differences in handwashing scores between preprogram and postprogram for all areas in only Group II ( p < .05).,"['children', 'April/June 2016, and 96 primary school students', 'Primary School Students']","['Interactive Education Versus Fluorescent Concretization', 'education with fluorescent gel; Group II receiving interactive education or control group continuing its normal education']","['handwashing scores', 'handwashing effectiveness (HWE', 'HWE']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.0260385,There were significant differences in handwashing scores between preprogram and postprogram for all areas in only Group II ( p < .05).,"[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Öncü', 'Affiliation': '1 Community Health Nursing Department, Faculty of Nursing, Mersin University, Mersin, Turkey.'}, {'ForeName': 'Sümbüle Köksoy', 'Initials': 'SK', 'LastName': 'Vayısoğlu', 'Affiliation': '1 Community Health Nursing Department, Faculty of Nursing, Mersin University, Mersin, Turkey.'}, {'ForeName': 'Diğdem', 'Initials': 'D', 'LastName': 'Lafci', 'Affiliation': '2 Fundementals of Nursing Department, Faculty of Nursing, Mersin University, Mersin, Turkey.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Yurtsever', 'Affiliation': '3 Mersin City Hospital, Mersin, Turkey.'}, {'ForeName': 'Ebru Ravlı', 'Initials': 'ER', 'LastName': 'Bulut', 'Affiliation': '4 Mersin University Health Research and Application Center, Mersin, Turkey.'}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Peker', 'Affiliation': '3 Mersin City Hospital, Mersin, Turkey.'}]",The Journal of school nursing : the official publication of the National Association of School Nurses,['10.1177/1059840518785447']
843,29799999,Phase 3 Assessment of the Automated Bone Scan Index as a Prognostic Imaging Biomarker of Overall Survival in Men With Metastatic Castration-Resistant Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial.,"Importance


Prostate cancer commonly metastasizes to bone, and bone metastases are associated with pathologic fractures, pain, and reduced survival. Bone disease is routinely visualized using the technetium Tc 99m (99mTc) bone scan; however, the standard interpretation of bone scan data relies on subjective manual assessment of counting metastatic lesion numbers. There is an unmet need for an objective and fully quantitative assessment of bone scan data.
Objective


To clinically assess in a prospectively defined analysis plan of a clinical trial the automated Bone Scan Index (aBSI) as an independent prognostic determinant of overall survival (OS) in men with metastatic castration-resistant prostate cancer (mCRPC).
Design, Setting, and Participants


This investigation was a prospectively planned analysis of the aBSI in a phase 3 multicenter randomized, double-blind, placebo-controlled clinical trial of tasquinimod (10TASQ10). Men with bone metastatic chemotherapy-naïve CRPC were recruited at 241 sites in 37 countries between March 2011 and August 2015. The statistical analysis plan to clinically evaluate the aBSI was prospectively defined and locked before unmasking of the 10TASQ10 study. The analysis of aBSI was conducted between May 25, 2016, and June 3, 2017.
Main Outcomes and Measures


The associations of baseline aBSI with OS, radiographic progression-free survival (rPFS), time to symptomatic progression, and time to opiate use for cancer pain.
Results


Of the total 1245 men enrolled, 721 were evaluable for the aBSI. The mean (SD) age (available for 719 men) was 70.6 (8.0) years (age range, 47-90 years). The aBSI population was representative of the total study population based on baseline characteristics. The aBSI (median, 1.07; range, 0-32.60) was significantly associated with OS (hazard ratio [HR], 1.20; 95% CI, 1.14-1.26; P < .001). The median OS by aBSI quartile (lowest to highest) was 34.7, 27.3, 21.7, and 13.3 months, respectively. The discriminative ability of the aBSI (C index, 0.63) in prognosticating OS was significantly higher than that of the manual lesion counting (C index, 0.60) (P = .03). In a multivariable survival model, a higher aBSI remained independently associated with OS (HR, 1.06; 95% CI, 1.01-1.11; P = .03). A higher aBSI was also independently associated with time to symptomatic progression (HR, 1.18; 95% CI, 1.13-1.23; P < .001) and time to opiate use for cancer pain (HR, 1.21; 95% CI, 1.14-1.30; P < .001).
Conclusions and Relevance


To date, this investigation is the largest prospectively analyzed study to validate the aBSI as an independent prognostic imaging biomarker of survival in mCRPC. These data support the prognostic utility of the aBSI as an objective imaging biomarker in the design and eligibility of clinical trials of systemic therapies for patients with mCRPC.
Trial Registration


ClinicalTrials.gov Identifier: NCT01234311.",2018,"The discriminative ability of the aBSI (C index, 0.63) in prognosticating OS was significantly higher than that of the manual lesion counting (C index, 0.60) (P = .03).","['patients with mCRPC', 'Men With Metastatic Castration-Resistant Prostate Cancer', 'men with metastatic castration-resistant prostate cancer (mCRPC', 'The mean (SD) age (available for 719 men) was 70.6 (8.0) years (age range, 47-90 years', 'Men with bone metastatic chemotherapy-naïve CRPC were recruited at 241 sites in 37 countries between March 2011 and August 2015', 'total 1245 men enrolled']","['tasquinimod (10TASQ10', 'placebo', 'automated Bone Scan Index (aBSI']","['time to opiate use for cancer pain', 'time to symptomatic progression', 'baseline aBSI with OS, radiographic progression-free survival (rPFS), time to symptomatic progression, and time to opiate use for cancer pain', 'overall survival (OS', 'discriminative ability of the aBSI (C index, 0.63) in prognosticating OS', 'median OS by aBSI quartile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C1956491', 'cui_str': 'tasquinimod'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0203668', 'cui_str': 'Radioisotope scan of bone'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4517468', 'cui_str': '0.63'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",1245.0,0.378839,"The discriminative ability of the aBSI (C index, 0.63) in prognosticating OS was significantly higher than that of the manual lesion counting (C index, 0.60) (P = .03).","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Armstrong', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, Duke Cancer Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Aseem', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'EXINI Diagnostics AB, Lund, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Edenbrandt', 'Affiliation': 'EXINI Diagnostics AB, Lund, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Bondesson', 'Affiliation': 'EXINI Diagnostics AB, Lund, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Bjartell', 'Affiliation': 'Division of Urological Cancers, Department of Translational Medicine, Lund University, Malmö, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Widmark', 'Affiliation': 'Umeå University, Umeå, Sweden.'}, {'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'San Camillo Hospital, Rome, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Pili', 'Affiliation': 'Indiana University School of Medicine, Indianapolis.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Tuvesson', 'Affiliation': 'Active Biotech AB, Lund, Sweden.'}, {'ForeName': 'Örjan', 'Initials': 'Ö', 'LastName': 'Nordle', 'Affiliation': 'Nordle Biostatistical Consultancy, Rydebäck, Sweden.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'The John Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}]",JAMA oncology,['10.1001/jamaoncol.2018.1093']
844,29959852,Enteral Protein Supplementation in Critically Ill Children: A Randomized Controlled Pilot and Feasibility Study.,"BACKGROUND


Loss of muscle mass in critically ill children can negatively impact outcomes. The aims of this study were to conduct a pilot randomized control trial (RCT) to examine the difference in protein delivery and nitrogen balance in critically ill children with enteral protein supplementation vs controls. We also aimed to assess the feasibility, safety, and tolerance of the pilot trial.
METHODS


This is a 3-arm RCT in critically ill children eligible for enteral nutrition (EN) therapy. Patients were randomized to 1 of the 3 groups: (1) control (routine EN), (2) polymeric protein module added to EN to reach protein goal by day 4, or (3) oligomeric protein supplementation. Demographics, clinical characteristics, nutrition status, and daily nutrition intake variables were recorded. Protein delivery, nitrogen balance, feasibility variables, and rate of adverse events were the outcomes.
RESULTS


After screening 286 consecutive patients admitted to the pediatric intensive care unit over 11 months, we enrolled and randomized 25 patients. Twenty-two patients (88% of the enrolled) completed the study procedures. Significantly higher protein prescription and actual protein intake within the first 5 days was achieved in the intervention groups, compared with the control group. Nitrogen balance was obtained in 15 patients. There was no significant difference between the groups for the rate of adverse effects and clinical outcomes.
CONCLUSION


In our pilot trial, protein supplementation was safe and well tolerated. Our preliminary results suggest that a larger RCT is potentially feasible, with some modifications of the entry criteria. Trial enrollment was low, likely due to restrictive entry criteria.",2019,"Significantly higher protein prescription and actual protein intake within the first 5 days was achieved in the intervention groups, compared with the control group.","['Critically Ill Children', '286 consecutive patients admitted to the pediatric intensive care unit over 11 months, we enrolled and randomized 25 patients', '15 patients', 'critically ill children eligible for enteral nutrition (EN) therapy', 'critically ill children', 'critically ill children with enteral protein supplementation vs controls', 'Twenty-two patients (88% of the enrolled) completed the study procedures']","['protein supplementation', 'control (routine EN), (2) polymeric protein module added to EN to reach protein goal by day 4, or (3) oligomeric protein supplementation', 'Enteral Protein Supplementation']","['safe and well tolerated', 'Protein delivery, nitrogen balance, feasibility variables, and rate of adverse events', 'protein delivery and nitrogen balance', 'actual protein intake', 'Nitrogen balance', 'rate of adverse effects and clinical outcomes', 'feasibility, safety, and tolerance', 'Demographics, clinical characteristics, nutrition status, and daily nutrition intake variables']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021710', 'cui_str': 'PICU - Pediatric intensive care unit'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0429631', 'cui_str': 'Nitrogen balance (observable entity)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]",25.0,0.0630773,"Significantly higher protein prescription and actual protein intake within the first 5 days was achieved in the intervention groups, compared with the control group.","[{'ForeName': 'Daniela B', 'Initials': 'DB', 'LastName': 'Hauschild', 'Affiliation': 'Postgraduate Program in Nutrition, Federal University of Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Luna D A', 'Initials': 'LDA', 'LastName': 'Oliveira', 'Affiliation': 'Postgraduate Program in Nutrition, Federal University of Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Mirelle S', 'Initials': 'MS', 'LastName': 'Farias', 'Affiliation': ""Nutrition, Joana de Gusmão Children's Hospital, Florianópolis, Brazil.""}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Barbosa', 'Affiliation': ""Nutrition, Joana de Gusmão Children's Hospital, Florianópolis, Brazil.""}, {'ForeName': 'Nilzete L', 'Initials': 'NL', 'LastName': 'Bresolin', 'Affiliation': ""Pediatric Intensive Care Unit, Joana de Gusmão Children's Hospital, Florianópolis, Brazil.""}, {'ForeName': 'Nilesh M', 'Initials': 'NM', 'LastName': 'Mehta', 'Affiliation': ""Division of Critical Care Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Yara M F', 'Initials': 'YMF', 'LastName': 'Moreno', 'Affiliation': 'Department of Nutrition, Federal University of Santa Catarina, Florianópolis, Brazil.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1416']
845,29934364,Learning From Past Failures of Oral Insulin Trials.,"Very recently one of the largest type 1 diabetes prevention trials using daily administration of oral insulin or placebo was completed. After 9 years of study enrollment and follow-up, the randomized controlled trial failed to delay the onset of clinical type 1 diabetes, which was the primary end point. The unfortunate outcome follows the previous large-scale trial, the Diabetes Prevention Trial-Type 1 (DPT-1), which again failed to delay diabetes onset with oral insulin or low-dose subcutaneous insulin injections in a randomized controlled trial with relatives at risk for type 1 diabetes. These sobering results raise the important question, ""Where does the type 1 diabetes prevention field move next?"" In this Perspective, we advocate for a paradigm shift in which smaller mechanistic trials are conducted to define immune mechanisms and potentially identify treatment responders. The stage is set for these interventions in individuals at risk for type 1 diabetes as Type 1 Diabetes TrialNet has identified thousands of relatives with islet autoantibodies and general population screening for type 1 diabetes risk is under way. Mechanistic trials will allow for better trial design and patient selection based upon molecular markers prior to large randomized controlled trials, moving toward a personalized medicine approach for the prevention of type 1 diabetes.",2018,"After 9 years of study enrollment and follow-up, the randomized controlled trial failed to delay the onset of clinical type 1 diabetes, which was the primary end point.",[],['oral insulin or placebo'],[],[],"[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.134577,"After 9 years of study enrollment and follow-up, the randomized controlled trial failed to delay the onset of clinical type 1 diabetes, which was the primary end point.","[{'ForeName': 'Aaron W', 'Initials': 'AW', 'LastName': 'Michels', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, University of Colorado School of Medicine, Aurora, CO aaron.michels@ucdenver.edu.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Gottlieb', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, University of Colorado School of Medicine, Aurora, CO.'}]",Diabetes,['10.2337/dbi17-0043']
846,31639195,Postoperative Venous Thromboembolism Prophylaxis Utilizing Enoxaparin Does Not Increase Bleeding Complications After Abdominal Body Contouring Surgery.,"BACKGROUND


Venous thromboembolism (VTE) chemoprophylaxis warrants an individualized, risk-stratified approach, and constitutes a relatively controversial topic in plastic surgery.
OBJECTIVES


The aim of this study was to determine the safety of a 7-day postoperative enoxaparin regimen for VTE prophylaxis compared with a single preoperative dose of heparin in abdominal body contouring surgery.
METHODS


This single-institution pre-post study investigated the safety of a 7-day enoxaparin postoperative regimen in abdominal body contouring procedures performed by a single surgeon from 2007 to 2018. Four procedures were included: traditional panniculectomy, abdominoplasty, fleur-de-lis panniculectomy, and body contouring liposuction. Group I patients received a single dose of 5000 U subcutaneous heparin in the preoperative period, and no postoperative chemical prophylaxis was administered. Group II patients received 40 mg subcutaneous enoxaparin in the immediate preoperative period, then once daily for 7 days postoperatively.
RESULTS


A total of 195 patients were included in the study, 66 in Group I and 129 in Group II. The groups demonstrated statistically similar VTE risk profiles, based on the 2005 Caprini risk-assessment model. There were no statistically significant differences in the 2 primary outcomes: postoperative bleeding and VTE events. Group I patients had higher reoperation rates (22.7% vs 10.1%, P = 0.029), which was secondary to higher rates of revision procedures.
CONCLUSIONS


A 7-day postoperative course of once-daily enoxaparin for VTE risk reduction in abdominal body contouring surgery does not significantly increase the risk of bleeding. Implementation of this regimen for postdischarge chemoprophylaxis, when indicated following individualized risk stratification, is appropriate.
LEVEL OF EVIDENCE: 4


",2020,"Group I patients had higher reoperation rates (22.7 percent versus 10.1 percent, p = 0.029), which was secondary to higher rates of revision procedures.
","['abdominal body contouring procedures performed by a single surgeon from 2007 to 2018', 'A total of 195 patients were included in the study, 66 in Group I and 129 in Group II', 'Four procedures were included: traditional panniculectomy, abdominoplasty, fleur-de-lis panniculectomy, and body contouring liposuction']","['heparin', 'Enoxaparin', 'enoxaparin', '40 mg subcutaneous enoxaparin']","['reoperation rates', 'risk of bleeding', 'postoperative bleeding and VTE events', 'VTE risk profiles', 'Bleeding Complications']","[{'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C2713286', 'cui_str': 'Panniculectomy'}, {'cui': 'C0198542', 'cui_str': 'Abdominoplasty'}, {'cui': 'C0038640', 'cui_str': 'Aspiration Lipectomy'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",195.0,0.111892,"Group I patients had higher reoperation rates (22.7 percent versus 10.1 percent, p = 0.029), which was secondary to higher rates of revision procedures.
","[{'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Vasilakis', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Gabriel M', 'Initials': 'GM', 'LastName': 'Klein', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Trostler', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Muntazim', 'Initials': 'M', 'LastName': 'Mukit', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Jocellie E', 'Initials': 'JE', 'LastName': 'Marquez', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Dagum', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Pannucci', 'Affiliation': 'Division of Plastic Surgery, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Sami U', 'Initials': 'SU', 'LastName': 'Khan', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY.'}]",Aesthetic surgery journal,['10.1093/asj/sjz274']
847,30151409,Mass Azithromycin Distribution and Community Microbiome: A Cluster-Randomized Trial.,"Background


Mass distributions of oral azithromycin have long been used to eliminate trachoma, and they are now being proposed to reduce childhood mortality. The observed benefit appears to be augmented with each additional treatment, suggesting a possible community-level effect. Here, we assess whether 2 biannual mass treatments of preschool children affect the community's gut microbiome at 6 months after the last distribution.
Methods


In this cluster-randomized controlled trial, children aged 1-60 months in the Dossa region of Niger were randomized at the village level to receive a single dose of azithromycin or placebo every 6 months. Fecal samples were collected 6 months after the second treatment for metagenomic deep sequencing. The prespecified primary outcome was the Euclidean PERMANOVA of the gut microbiome, or effectively the distance between the genus-level centroid at the community level, with the secondary outcome being the Simpson's α diversity.
Results


In the azithromycin arm, the gut microbial structures were significantly different than in the placebo arm (Euclidean PERMANOVA,  P  < .001). Further, the diversity of the gut microbiome in the azithromycin arm was significantly lower than in the placebo arm (inverse Simpson's index,  P  = .005).
Conclusions


Two mass azithromycin administrations, 6 months apart, in preschool children led to long-term alterations of the gut microbiome structure and community diversity. Here, long-term microbial alterations in the community did not imply disease but were associated with an improvement in childhood mortality.
Clinical Trials Registration


NCT02048007.",2018,"In the azithromycin arm, the gut microbial structures were significantly different than in the placebo arm (Euclidean PERMANOVA,  P  < .001).","['preschool children', 'children aged 1-60 months in the Dossa region of Niger']","['azithromycin or placebo', 'azithromycin', 'placebo', 'Azithromycin Distribution and Community Microbiome']","['childhood mortality', 'gut microbiome, or effectively the distance between the genus-level centroid at the community level', 'diversity of the gut microbiome', 'gut microbial structures']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}]","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",,0.356619,"In the azithromycin arm, the gut microbial structures were significantly different than in the placebo arm (Euclidean PERMANOVA,  P  < .001).","[{'ForeName': 'Thuy', 'Initials': 'T', 'LastName': 'Doan', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco, California.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Hinterwirth', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco, California.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center Niger, Republique du Niger, Niger.'}, {'ForeName': 'Sun Y', 'Initials': 'SY', 'LastName': 'Cotter', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco, California.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Ray', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco, California.'}, {'ForeName': 'Kieran S', 'Initials': 'KS', 'LastName': ""O'Brien"", 'Affiliation': 'Francis I. Proctor Foundation, San Francisco, California.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhong', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco, California.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Chow', 'Affiliation': 'Department of Biochemistry and Biophysics, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Zhaoxia', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco, California.'}, {'ForeName': 'Susie L', 'Initials': 'SL', 'LastName': 'Cummings', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco, California.'}, {'ForeName': 'Dionna', 'Initials': 'D', 'LastName': 'Fry', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco, California.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Oldenburg', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco, California.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Worden', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco, California.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco, California.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco, California.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I. Proctor Foundation, San Francisco, California.'}]",Open forum infectious diseases,['10.1093/ofid/ofy182']
848,29900874,"Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial.","BACKGROUND


Myocardial injury after non-cardiac surgery (MINS) increases the risk of cardiovascular events and deaths, which anticoagulation therapy could prevent. Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown. The MANAGE trial assessed the potential of dabigatran to prevent major vascular complications among such patients.
METHODS


In this international, randomised, placebo-controlled trial, we recruited patients from 84 hospitals in 19 countries. Eligible patients were aged at least 45 years, had undergone non-cardiac surgery, and were within 35 days of MINS. Patients were randomly assigned (1:1) to receive dabigatran 110 mg orally twice daily or matched placebo for a maximum of 2 years or until termination of the trial and, using a partial 2-by-2 factorial design, patients not taking a proton-pump inhibitor were also randomly assigned (1:1) to omeprazole 20 mg once daily, for which results will be reported elsewhere, or matched placebo to measure its effect on major upper gastrointestinal complications. Research personnel randomised patients through a central 24 h computerised randomisation system using block randomisation, stratified by centre. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary efficacy outcome was the occurrence of a major vascular complication, a composite of vascular mortality and non-fatal myocardial infarction, non-haemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism. The primary safety outcome was a composite of life-threatening, major, and critical organ bleeding. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01661101.
FINDINGS


Between Jan 10, 2013, and July 17, 2017, we randomly assigned 1754 patients to receive dabigatran (n=877) or placebo (n=877); 556 patients were also randomised in the omeprazole partial factorial component. Study drug was permanently discontinued in 401 (46%) of 877 patients allocated to dabigatran and 380 (43%) of 877 patients allocated to placebo. The composite primary efficacy outcome occurred in fewer patients randomised to dabigatran than placebo (97 [11%] of 877 patients assigned to dabigatran vs 133 [15%] of 877 patients assigned to placebo; hazard ratio [HR] 0·72, 95% CI 0·55-0·93; p=0·0115). The primary safety composite outcome occurred in 29 patients (3%) randomised to dabigatran and 31 patients (4%) randomised to placebo (HR 0·92, 95% CI 0·55-1·53; p=0·76).
INTERPRETATION


Among patients who had MINS, dabigatran 110 mg twice daily lowered the risk of major vascular complications, with no significant increase in major bleeding. 
Patients with MINS have a poor prognosis; dabigatran 110 mg twice daily has the potential to help many of the 8 million adults globally who have MINS to reduce their risk of a major vascular complication [corrected].
FUNDING


Boehringer Ingelheim and Canadian Institutes of Health Research.",2018,"Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown.","['recruited patients from 84 hospitals in 19 countries', 'patients with myocardial injury after non-cardiac surgery (MANAGE', 'n=877); 556 patients', 'Between Jan 10, 2013, and July 17, 2017, we randomly assigned 1754 patients to receive', 'Eligible patients were aged at least 45 years, had undergone non-cardiac surgery, and were within 35 days of MINS', 'Study drug was permanently discontinued in 401 (46%) of 877 patients allocated to dabigatran and 380 (43%) of 877 patients allocated to']","['Dabigatran', 'placebo', 'omeprazole partial factorial component', 'proton-pump inhibitor', 'dabigatran', 'omeprazole', 'dabigatran 110 mg orally twice daily or matched placebo']","['hazard ratio [HR', 'perioperative venous thromboembolism', 'major bleeding', 'composite of life-threatening, major, and critical organ bleeding', 'occurrence of a major vascular complication, a composite of vascular mortality and non-fatal myocardial infarction, non-haemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism', 'risk of major vascular complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0264984', 'cui_str': 'Thrombosis of arteries of the extremities'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",1754.0,0.780445,"Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown.","[{'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Devereaux', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada. Electronic address: philipj@mcmaster.ca.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Duceppe', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Department of Medicine, University of Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Guyatt', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Tandon', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Reitze', 'Initials': 'R', 'LastName': 'Rodseth', 'Affiliation': 'Department of Anaesthesia, University of KwaZulu-Natal, Pietermaritzburg, South Africa.'}, {'ForeName': 'Bruce M', 'Initials': 'BM', 'LastName': 'Biccard', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ""Department of Pharmacology, St John's Medical College and Research Institute, Bangalore, India.""}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Szczeklik', 'Affiliation': 'Department of Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Meyhoff', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Vincent', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Franzosi', 'Affiliation': 'Department of Cardiovascular Research, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.'}, {'ForeName': 'Sadeesh K', 'Initials': 'SK', 'LastName': 'Srinathan', 'Affiliation': 'Department of Surgery, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Erb', 'Affiliation': ""Department of Anesthesiology and Perioperative Medicine, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Magloire', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Neary', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Mangala', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': ""Department of Pharmacology, St John's Medical College and Research Institute, Bangalore, India.""}, {'ForeName': 'Prashant V', 'Initials': 'PV', 'LastName': 'Rahate', 'Affiliation': 'Department of Surgery, Rahate Surgical Hospital, Nagpur, India.'}, {'ForeName': 'Navneet K', 'Initials': 'NK', 'LastName': 'Chaudhry', 'Affiliation': 'Department of Surgery, Christian Medical College Hospital, Ludhiana, India.'}, {'ForeName': 'Bongani', 'Initials': 'B', 'LastName': 'Mayosi', 'Affiliation': 'Department of Medicine, Groote Schuur Hospital and University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'de Nadal', 'Affiliation': ""Department of Anesthesiology, Hospital Universitari Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Pilar Paniagua', 'Initials': 'PP', 'LastName': 'Iglesias', 'Affiliation': 'Department of Anesthesiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Instituto de Ensino e Pesquisa do Hospital do Coração (IEP-HCor), São Paulo, Brazil.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Villar', 'Affiliation': 'Departamento de Investigaciones, Fundación Cardioinfantil-Instituto de Cardiología (Bogotá) and Facultad de Ciencias de la Salud, Universidad Autónoma de Bucaramanga, Colombia.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Botto', 'Affiliation': 'Estudios Clínicos Latinoamérica (ECLA), Rosario and Hospital Austral, Pilar, Argentina.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Eikelboom', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Anesthesiology Institute, Cleveland, OH, United States.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Kearon', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Pettit', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Mukul', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Connolly', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Shrikant I', 'Initials': 'SI', 'LastName': 'Bangdiwala', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Purnima', 'Initials': 'P', 'LastName': 'Rao-Melacini', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hoeft', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Salim', 'Initials': 'S', 'LastName': 'Yusuf', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(18)30832-8']
849,31641769,Bedtime hypertension treatment improves cardiovascular risk reduction: the Hygia Chronotherapy Trial.,"AIMS


The Hygia Chronotherapy Trial, conducted within the clinical primary care setting, was designed to test whether bedtime in comparison to usual upon awakening hypertension therapy exerts better cardiovascular disease (CVD) risk reduction.
METHODS AND RESULTS


In this multicentre, controlled, prospective endpoint trial, 19 084 hypertensive patients (10 614 men/8470 women, 60.5 ± 13.7 years of age) were assigned (1:1) to ingest the entire daily dose of ≥1 hypertension medications at bedtime (n = 9552) or all of them upon awakening (n = 9532). At inclusion and at every scheduled clinic visit (at least annually) throughout follow-up, ambulatory blood pressure (ABP) monitoring was performed for 48 h. During the 6.3-year median patient follow-up, 1752 participants experienced the primary CVD outcome (CVD death, myocardial infarction, coronary revascularization, heart failure, or stroke). Patients of the bedtime, compared with the upon-waking, treatment-time regimen showed significantly lower hazard ratio-adjusted for significant influential characteristics of age, sex, type 2 diabetes, chronic kidney disease, smoking, HDL cholesterol, asleep systolic blood pressure (BP) mean, sleep-time relative systolic BP decline, and previous CVD event-of the primary CVD outcome [0.55 (95% CI 0.50-0.61), P < 0.001] and each of its single components (P < 0.001 in all cases), i.e. CVD death [0.44 (0.34-0.56)], myocardial infarction [0.66 (0.52-0.84)], coronary revascularization [0.60 (0.47-0.75)], heart failure [0.58 (0.49-0.70)], and stroke [0.51 (0.41-0.63)].
CONCLUSION


Routine ingestion by hypertensive patients of ≥1 prescribed BP-lowering medications at bedtime, as opposed to upon waking, results in improved ABP control (significantly enhanced decrease in asleep BP and increased sleep-time relative BP decline, i.e. BP dipping) and, most importantly, markedly diminished occurrence of major CVD events.
TRIAL REGISTRATION


ClinicalTrials.gov, number NCT00741585.",2019,"Patients of the bedtime, compared with the upon-waking, treatment-time regimen showed significantly lower hazard ratio-adjusted for significant influential characteristics of age, sex, type 2 diabetes, chronic kidney disease, smoking, HDL cholesterol, asleep systolic blood pressure (BP) mean, sleep-time relative systolic BP decline, and previous CVD event-of the primary CVD outcome [0.55","['19 084 hypertensive patients (10 614 men/8470 women, 60.5\u2009±\u200913.7\u2009years of age']",['Bedtime hypertension treatment'],"['chronic kidney disease, smoking, HDL cholesterol, asleep systolic blood pressure (BP) mean, sleep-time relative systolic BP decline, and previous CVD event-of the primary CVD outcome', 'cardiovascular risk reduction', 'asleep BP and increased sleep-time relative BP decline, i.e. BP dipping', 'ABP control', 'primary CVD outcome (CVD death, myocardial infarction, coronary revascularization, heart failure, or stroke', 'CVD death', 'myocardial infarction', 'coronary revascularization', 'heart failure', 'ambulatory blood pressure (ABP) monitoring', 'cardiovascular disease (CVD) risk reduction']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0378785', 'cui_str': 'DIPS'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0242876', 'cui_str': 'Blood Pressure Monitoring, Ambulatory'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",1752.0,0.186905,"Patients of the bedtime, compared with the upon-waking, treatment-time regimen showed significantly lower hazard ratio-adjusted for significant influential characteristics of age, sex, type 2 diabetes, chronic kidney disease, smoking, HDL cholesterol, asleep systolic blood pressure (BP) mean, sleep-time relative systolic BP decline, and previous CVD event-of the primary CVD outcome [0.55","[{'ForeName': 'Ramón C', 'Initials': 'RC', 'LastName': 'Hermida', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Crespo', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Domínguez-Sardiña', 'Affiliation': 'Estructura de Xestión Integrada de Vigo, Servicio Galego de Saúde (SERGAS), Vigo, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Otero', 'Affiliation': 'Servicio de Nefrología, Complejo Hospitalario Universitario, Estructura de Xestión Integrada de Ourense, Verín e O Barco de Valdeorras, Servicio Galego de Saúde (SERGAS), Ourense 32005, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Moyá', 'Affiliation': 'Estructura de Xerencia Integrada Pontevedra e O Salnés, Servicio Galego de Saúde (SERGAS), Pontevedra, Spain.'}, {'ForeName': 'María T', 'Initials': 'MT', 'LastName': 'Ríos', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Sineiro', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'María C', 'Initials': 'MC', 'LastName': 'Castiñeira', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Callejas', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Pousa', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Salgado', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Durán', 'Affiliation': 'Estructura de Xestión Integrada de Vigo, Servicio Galego de Saúde (SERGAS), Vigo, Spain.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Sánchez', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Fernández', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'Artemio', 'Initials': 'A', 'LastName': 'Mojón', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'Diana E', 'Initials': 'DE', 'LastName': 'Ayala', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehz754']
850,31650711,Evaluation of the Pharmacokinetic Interaction Between the Voltage- and Use-Dependent Nav1.7 Channel Blocker Vixotrigine and Carbamazepine in Healthy Volunteers.,"Vixotrigine is a voltage- and use-dependent Nav1.7 channel blocker under investigation for the treatment of peripheral neuropathic pain conditions, including trigeminal neuralgia. Vixotrigine is metabolized primarily via uridine diphosphate-glucuronosyltransferases (UGTs). Carbamazepine, a UGT and cytochrome P450 3A4 inducer, is a first-line treatment for trigeminal neuralgia. We conducted a double-blind, randomized, placebo-controlled, parallel-group, single-center phase 1 study to investigate the impact of coadministering vixotrigine and carbamazepine on their respective pharmacokinetics (PK) in healthy volunteers, the safety and tolerability of combined treatment, and PK recovery of vixotrigine following carbamazepine discontinuation. Randomly assigned treatments were carbamazepine (100 mg twice a day, days 1-3 and 200 mg twice a day, days 4-21) or placebo on days 1 to 21. All volunteers received vixotrigine 150 mg 3 times a day on days 16 to 28. At prespecified times, whole-blood samples were collected for PK assessment. Statistical analyses were performed on the log-transformed PK parameters area under the concentration-time curve within a dosing interval (AUC 0-tau  ) and maximum observed concentration (C max  ) for vixotrigine, carbamazepine, and metabolites. Vixotrigine AUC 0-tau  and C max  were reduced by 31.6% and 26.3%, respectively, when coadministered with carbamazepine compared with placebo. Seven days after carbamazepine discontinuation, vixotrigine AUC 0-tau  and C max  remained 24.5% and 21.4% lower compared with placebo. Carbamazepine AUC 0-tau  and C max  were <10% lower when coadministered with vixotrigine compared on days 15 and 21. Vixotrigine/carbamazepine coadministration was well tolerated. These results suggest that vixotrigine does not have an effect on carbamazepine PK, and although carbamazepine has an effect on the exposure of vixotrigine, the effect is not considered clinically relevant.",2020,Carbamazepine AUC 0-tau  and C max  were <10% lower when coadministered with vixotrigine compared on days 15 and 21.,"['Healthy Volunteers', 'healthy volunteers']","['Voltage- and Use-Dependent Nav1.7 Channel Blocker Vixotrigine and Carbamazepine', 'carbamazepine', 'placebo', 'vixotrigine and carbamazepine', 'vixotrigine', 'carbamazepine discontinuation', 'Vixotrigine/carbamazepine', 'Carbamazepine', 'Vixotrigine']","['tolerated', 'vixotrigine AUC 0-tau  and C max', 'Vixotrigine AUC 0-tau  and C max', 'Carbamazepine AUC 0-tau  and C max', 'safety and tolerability']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0439799', 'cui_str': 'Channel (qualifier value)'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.336116,Carbamazepine AUC 0-tau  and C max  were <10% lower when coadministered with vixotrigine compared on days 15 and 21.,"[{'ForeName': 'Joi', 'Initials': 'J', 'LastName': 'Dunbar', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Versavel', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Tate', 'Affiliation': 'Convergence Pharmaceuticals, a Biogen company, Cambridge, UK.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Morisset', 'Affiliation': 'Convergence Pharmaceuticals, a Biogen company, Cambridge, UK.'}, {'ForeName': 'Gerard M P', 'Initials': 'GMP', 'LastName': 'Giblin', 'Affiliation': 'Convergence Pharmaceuticals, a Biogen company, Cambridge, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Palmer', 'Affiliation': 'Convergence Pharmaceuticals, a Biogen company, Cambridge, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Tidemann-Miller', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Himanshu', 'Initials': 'H', 'LastName': 'Naik', 'Affiliation': 'Biogen, Cambridge, Massachusetts, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.739']
851,31648655,Pregabalin augmentation for resistant obsessive-compulsive disorder: a double-blind placebo-controlled clinical trial.,"BACKGROUND AND OBJECTIVE.


Glutamate dysfunction has been shown to be associated with pathophysiology of obsessive-compulsive disorder (OCD). Our objective is to survey the effects of pregabalin (a glutamate-modulating agent) as an augmenting treatment for resistant OCD.
PATIENTS AND METHODS.


In this 12-week double-blind placebo-controlled clinical trial, 56 patients with resistant OCD were randomly allocated to receive either pregabalin or placebo plus their current medication (sertraline). Yale-Brown Obsessive Compulsive Scale (Y-BOCS) was used to evaluate the outcomes. Adverse effects were also registered.
RESULTS.


Of the 56 patients with resistant OCD who were randomly allocated in 2 groups of pregabalin (n = 28) and placebo group (n = 28), 42 patients (22 in pregabalin group and 20 in placebo group) completed the trial. Throughout the trial, the mean score decreased from 26.13± 7.03 to 8.81 ± 3.47 in the pregabalin group (p < 0) and from 26.85 ± 4.34 to 17.63 ± 4.22 in the placebo group (p < 0). At the end of trial, 16 (57.14%) patients in the pregabalin group and 2 (7.14%) patients in the placebo group showed more than 35% decline in YBOCS (p < .01). The pregabalin group showed good tolerability and safety.
CONCLUSIONS.


Our study revealed that pregabalin, as an augmenting medication, is more effective than placebo in the treatment of patients with resistant OCD.",2020,"At the end of trial, 16 (57.14%) patients in the pregabalin group and 2 (7.14%) patients in the placebo group showed more than 35% decline in YBOCS (p < .01).","['patients with resistant OCD', 'resistant obsessive-compulsive disorder', '56 patients with resistant OCD']","['pregabalin', 'Pregabalin augmentation', 'pregabalin or placebo plus their current medication (sertraline', 'placebo', 'pregabalin group and 20 in placebo']","['YBOCS', 'Yale-Brown Obsessive Compulsive Scale', 'good tolerability and safety', 'mean score', 'Adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}]","[{'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",56.0,0.333824,"At the end of trial, 16 (57.14%) patients in the pregabalin group and 2 (7.14%) patients in the placebo group showed more than 35% decline in YBOCS (p < .01).","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Mowla', 'Affiliation': 'Substance Abuse and Mental Health Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehrnoosh', 'Initials': 'M', 'LastName': 'Ghaedsharaf', 'Affiliation': 'Substance Abuse and Mental Health Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",CNS spectrums,['10.1017/S1092852919001500']
852,29981739,"Systemic Disease and Long-term Intraocular Pressure Mean, Peak, and Variability in Nonglaucomatous Eyes.","PURPOSE


Elevated intraocular pressure (IOP) is a well-known risk factor in glaucoma development and progression. As most glaucoma risk factors are not modifiable, IOP remains the sole focus of medical and surgical therapy. Identifying modifiable factors and their effects on IOP, such as systemic diseases, is therefore of interest. The objective is to assess the long-term, longitudinal relationship between systemic diseases and IOP mean, peak, and variability, including diabetes, hypertension, body mass index (BMI), and smoking status.
DESIGN


Secondary analysis of randomized clinical trial data.
METHODS


Longitudinal IOP and systemic disease data from the Age-Related Eye Disease Study (AREDS), a randomized clinical trial of high-dose antioxidants, was analyzed.
STUDY POPULATION


A total of 3909 older participants without a reported diagnosis of glaucoma or glaucoma treatment during AREDS with up to 12 years of annual IOP and systemic disease data.
MAIN OUTCOME MEASURES


Independent systemic disease risk factors associated with IOP.
RESULTS


Univariate analysis identified numerous systemic disease factors associated with IOP mean, peak, and variability. Longitudinal adjusted models identified diabetes, obesity, and systolic hypertension as significantly associated with increased IOP, while systemic beta-blocker use was inversely associated.
CONCLUSIONS


Results demonstrate a relationship between multiple systemic diseases and IOP; moreover, they demonstrate that systemic diseases influence additional parameters beyond mean IOP, such as IOP peak and variability. Although only to be taken within the context of IOP, these population-level trends reveal potentially modifiable factors in IOP control, and are particularly important in the context of increasing obesity and diabetes prevalence rates in American adults.",2018,"Longitudinal adjusted models identified diabetes, obesity, and systolic hypertension as significantly associated with increased IOP, while systemic beta-blocker use was inversely associated.
","['3909 older participants without a reported diagnosis of glaucoma or glaucoma treatment during AREDS with up to 12 years of annual IOP and systemic disease data', 'American adults', 'Longitudinal IOP and systemic disease data from the Age-Related Eye Disease Study (AREDS']",[],"['Systemic Disease and Long-term Intraocular Pressure Mean, Peak, and Variability', 'IOP mean, peak, and variability, including diabetes, hypertension, body mass index (BMI), and smoking status', 'IOP peak and variability', 'diabetes, obesity, and systolic hypertension']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0442893', 'cui_str': 'Systemic illness (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0015397', 'cui_str': 'Eye Diseases'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C0442893', 'cui_str': 'Systemic illness (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0221155', 'cui_str': 'Systolic hypertension (disorder)'}]",3909.0,0.144437,"Longitudinal adjusted models identified diabetes, obesity, and systolic hypertension as significantly associated with increased IOP, while systemic beta-blocker use was inversely associated.
","[{'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Dikopf', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Thasarat S', 'Initials': 'TS', 'LastName': 'Vajaranant', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Joslin', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, University of Illinois at Chicago, Chicago, Illinois, USA; Division of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Chicago, Illinois, USA. Electronic address: charjosl@uic.edu.'}]",American journal of ophthalmology,['10.1016/j.ajo.2018.06.021']
853,31641767,"Oral vs Intravenous Antibiotics for Patients With Klebsiella pneumoniae Liver Abscess: A Randomized, Controlled Noninferiority Study.","BACKGROUND


Klebsiella pneumoniae liver abscess (KLA) is emerging worldwide due to hypermucoviscous strains with a propensity for metastatic infection. Treatment includes drainage and prolonged intravenous antibiotics. We aimed to determine whether oral antibiotics were noninferior to continued intravenous antibiotics for KLA.
METHODS


This noninferiority, parallel group, randomized, clinical trial recruited hospitalized adults with liver abscess and K. pneumoniae isolated from blood or abscess fluid who had received ≤7 days of effective antibiotics at 3 sites in Singapore. Patients were randomized 1:1 to oral (ciprofloxacin) or intravenous (ceftriaxone) antibiotics for 28 days. If day 28 clinical response criteria were not met, further oral antibiotics were prescribed until clinical response was met. The primary endpoint was clinical cure assessed at week 12 and included a composite of absence of fever in the preceding week, C-reactive protein <20 mg/L, and reduction in abscess size. A noninferiority margin of 12% was used.
RESULTS


Between November 2013 and October 2017, 152 patients (mean age, 58.7 years; 25.7% women) were recruited, following a median 5 days of effective intravenous antibiotics. A total of 106 (69.7%) underwent abscess drainage; 71/74 (95.9%) randomized to oral antibiotics met the primary endpoint compared with 72/78 (92.3%) randomized to intravenous antibiotics (risk difference, 3.6%; 2-sided 95% confidence interval, -4.9% to 12.8%). Effects were consistent in the per-protocol population. Nonfatal serious adverse events occurred in 12/72 (16.7%) in the oral group and 13/77 (16.9%) in the intravenous group.
CONCLUSIONS


Oral antibiotics were noninferior to intravenous antibiotics for the early treatment of KLA.
CLINICAL TRIALS REGISTRATION


NCT01723150.",2020,"Nonfatal serious adverse events occurred in 12/72 (16.7%) in the oral group and 13/77 (16.9%) in the intravenous group.
","['Klebsiella pneumoniae liver abscess (KLA', 'hospitalized adults with liver abscess and K. pneumoniae isolated from blood or abscess fluid who had received ≤7 days of effective antibiotics at 3 sites in Singapore', 'Between November 2013 and October 2017, 152 patients (mean age, 58.7 years; 25.7% women', 'Patients With Klebsiella pneumoniae Liver Abscess']","['Oral vs Intravenous Antibiotics', 'oral (ciprofloxacin) or intravenous (ceftriaxone) antibiotics', 'intravenous antibiotics']","['clinical cure', 'abscess size', 'Nonfatal serious adverse events', 'composite of absence of fever']","[{'cui': 'C0001699', 'cui_str': 'Klebsiella pneumoniae'}, {'cui': 'C0023885', 'cui_str': 'Abscess, Hepatic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0277797', 'cui_str': 'Apyrexial'}]",152.0,0.200811,"Nonfatal serious adverse events occurred in 12/72 (16.7%) in the oral group and 13/77 (16.9%) in the intravenous group.
","[{'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Molton', 'Affiliation': 'Division of Infectious Diseases, University Medicine Cluster, National University Hospital, Singapore.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Chan', 'Affiliation': 'Infectious Diseases Department, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Kalimuddin', 'Affiliation': 'Department of Infectious Diseases, Singapore General Hospital, Singapore.'}, {'ForeName': 'Jolene', 'Initials': 'J', 'LastName': 'Oon', 'Affiliation': 'Division of Infectious Diseases, University Medicine Cluster, National University Hospital, Singapore.'}, {'ForeName': 'Barnaby E', 'Initials': 'BE', 'LastName': 'Young', 'Affiliation': 'Infectious Diseases Department, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Jenny G', 'Initials': 'JG', 'LastName': 'Low', 'Affiliation': 'Department of Infectious Diseases, Singapore General Hospital, Singapore.'}, {'ForeName': 'Brenda M A', 'Initials': 'BMA', 'LastName': 'Salada', 'Affiliation': 'Division of Infectious Diseases, University Medicine Cluster, National University Hospital, Singapore.'}, {'ForeName': 'Tau Hong', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Infectious Diseases Department, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Wijaya', 'Affiliation': 'Department of Infectious Diseases, Singapore General Hospital, Singapore.'}, {'ForeName': 'Dale A', 'Initials': 'DA', 'LastName': 'Fisher', 'Affiliation': 'Division of Infectious Diseases, University Medicine Cluster, National University Hospital, Singapore.'}, {'ForeName': 'Ezlyn', 'Initials': 'E', 'LastName': 'Izharuddin', 'Affiliation': 'Infectious Diseases Department, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Tse Hsien', 'Initials': 'TH', 'LastName': 'Koh', 'Affiliation': 'Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Jeanette W P', 'Initials': 'JWP', 'LastName': 'Teo', 'Affiliation': 'Department of Laboratory Medicine, Microbiology Unit, National University Hospital, Singapore.'}, {'ForeName': 'Prabha Unny', 'Initials': 'PU', 'LastName': 'Krishnan', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore.'}, {'ForeName': 'Bien Peng', 'Initials': 'BP', 'LastName': 'Tan', 'Affiliation': 'Diagnostic Radiology, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Winston W L', 'Initials': 'WWL', 'LastName': 'Woon', 'Affiliation': 'Hepato-Pancreato-Biliary Surgery Service, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Infectious Diseases Department, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Singapore Clinical Research Institute, Singapore.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'School of Public Health, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Moorakonda', 'Affiliation': 'Singapore Clinical Research Institute, Singapore.'}, {'ForeName': 'Kah Hung', 'Initials': 'KH', 'LastName': 'Yuen', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Boon Piang', 'Initials': 'BP', 'LastName': 'Cher', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Yoong', 'Affiliation': 'Center for Economic and Social Research, University of Southern California, Los Angeles, California.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Lye', 'Affiliation': 'Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Archuleta', 'Affiliation': 'Division of Infectious Diseases, University Medicine Cluster, National University Hospital, Singapore.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz881']
854,29730393,Virtual immersive gaming to optimize recovery (VIGOR) in low back pain: A phase II randomized controlled trial.,"The virtual immersive gaming to optimize recovery (VIGOR) study is a randomized controlled trial of the effects of virtual reality games to encourage lumbar spine flexion among individuals with chronic low back pain and fear of movement. Whereas traditional graded activity or graded exposure therapies for chronic low back pain have high attrition and poor long-term efficacy, we believe that virtual reality games have distinct advantages that can enhance adherence and clinical outcomes. First, they are engaging and enjoyable activities that can distract from pain and fear of harm. In addition, because they gradually reinforce increases in lumbar spine flexion to achieve game objectives, continued engagement over time is expected to promote recovery through restoration of normal spinal motion. The study design includes two treatment groups which differ in the amount of lumbar flexion required to achieve the game objectives. All participants will play the games for nine weeks, and pre-treatment to 1-week post-treatment changes in pain and disability will serve as the co-primary clinical outcomes. In addition, changes in lumbar flexion and expectations of pain/harm will be examined as potential treatment outcome mediators. Maintenance of treatment outcomes will also be assessed for up to 48-weeks post-treatment. In brief, we hypothesize that the virtual reality games will reduce pain and disability by promoting spinal motion and allowing participants to develop an implicit understanding that they are capable of engaging in significant lumbar spine motion in their daily lives without a risk of injury to their back.",2018,The virtual immersive gaming to optimize recovery (VIGOR) study is a randomized controlled trial of the effects of virtual reality games to encourage lumbar spine flexion among individuals with chronic low back pain and fear of movement.,"['low back pain', 'individuals with chronic low back pain and fear of movement']","['Virtual immersive gaming to optimize recovery (VIGOR', 'virtual reality games', 'virtual immersive gaming']","['lumbar spine flexion', 'pain and disability', 'lumbar flexion and expectations of pain/harm']","[{'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",,0.101841,The virtual immersive gaming to optimize recovery (VIGOR) study is a randomized controlled trial of the effects of virtual reality games to encourage lumbar spine flexion among individuals with chronic low back pain and fear of movement.,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, OH, USA. Electronic address: France@ohio.edu.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Thomas', 'Affiliation': 'Division of Physical Therapy, School of Rehabilitation and Communication Sciences, Ohio University, Athens, OH, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2018.05.001']
855,31634870,Investigations of Silymarine Effects on Prognosis of Patients With Severe and Moderate Traumatic Brain Injury.,"Objective


The purpose of this study was to evaluate Silymarine effects on prognosis of patients with severe and moderate traumatic brain injury.
Study Design


This double blind, placebo-controlled clinical trial.
Setting


Valiasr hospital hospital in Arak, Iran.
Subjects and Methods


Research was performed among patients between 15 and 65 years of age with severe moderate (Glasgow Coma Scale score 9 to 12) and moderate (GCS 3 to 8) traumatic brain injury (TBI). Patients were divided into two groups (Each group: 40 patients). Patients assigned to the control groupwere receiving all standard treatments. Patients in case groups were administered 140 mg of silymarin every 8 hours for 7 days. We Checked the Glasgow Outcome Scale (GOS), GCS, age, gender, location, mechanism of trauma, site of accident and the incidence time of accident to arrival at emergency unite. Statistical analysis was conducted using SPSS (SPSS version 18; Chicago, IL).
Results


Our findings suggested that there was no a significant difference between intervention group and control in terms of parameters as GOS, GCS, age, gender, location, mechanism of trauma, and site of accident and the incidence time of accident to arrival at emergency unite (P > .05). Brain CT in two groups showed a significant difference (P = .002), where in the silymarin group there were more normal cases when comparing with control group.
Conclusions


Silymarin did not reveal a significant effect for improving prognosis of patients with moderate and severe TBI.",2020,"Brain CT in two groups showed a significant difference (P = .002), where in the silymarin group there were more normal cases when comparing with control group.
","['patients between 15 and 65 years of age with severe moderate (Glasgow Coma Scale score 9 to 12) and moderate (GCS 3 to 8) traumatic brain injury (TBI', 'Setting\n\n\nValiasr hospital hospital in Arak, Iran', 'Patients With Severe and Moderate Traumatic Brain Injury', 'patients with severe and moderate traumatic brain injury']","['placebo', 'Silymarine', 'silymarin']","['Glasgow Outcome Scale (GOS), GCS, age, gender, location, mechanism of trauma, site of accident and the incidence time of accident to arrival at emergency unite', 'GOS, GCS, age, gender, location, mechanism of trauma, and site of accident and the incidence time of accident to arrival at emergency unite']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0017594', 'cui_str': 'Glasgow coma scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0037135', 'cui_str': 'Silymarin'}]","[{'cui': 'C0701887', 'cui_str': 'Glasgow Outcome Scale'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C1961149', 'cui_str': 'Accidental physical contact (event)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}]",,0.096076,"Brain CT in two groups showed a significant difference (P = .002), where in the silymarin group there were more normal cases when comparing with control group.
","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Nazemi Rafi', 'Affiliation': ''}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Jafari', 'Affiliation': ''}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Solhi', 'Affiliation': ''}, {'ForeName': 'Jila', 'Initials': 'J', 'LastName': 'Mohseni', 'Affiliation': ''}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Kamali', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
856,30298416,A Novel Strategy of Laparoscopic Insufflation Rate Improving Shoulder Pain: Prospective Randomized Study.,"BACKGROUND


Laparoscopic surgery is the main trend method in a variety of surgical fields. Post-operative shoulder pain remains a bothersome issue although many surgical techniques have been applied to minimize it. A simple novel approach to reduce shoulder pain without adverse effects during and after laparoscopic surgery is desired.
METHODS


This prospective randomized controlled study was conducted to enroll a total of 140 patients to evaluate the efficacy of low flow rate (1 L/min) for induction followed by high flow rate (10 L/min) for maintaining 12 mmHg pneumoperitoneum (group A, n = 70) during laparoscopic cholecystectomy (LC), compared to the continuous high flow rate group (group B, n = 70) in postoperative shoulder pain and other clinical features. The 10-visual analog scale (VAS) was applied for the severity of shoulder pain and scores were obtained at 1, 6, 12, 24, and 48 h after LC.
RESULTS


There was no obvious difference in baseline characteristics as well as operative time, occurrence of bradycardia, or hospital stay between groups. The incidence of shoulder pain was not significantly different (group A 45.7% vs group B 48.6%, p = 0.866). However, the patients in group A with shoulder pain reported significantly less pain scores (p < 0.001) at 12 and 24 h after surgery, compared with those in group B.
CONCLUSIONS


Applying the strategy of low flow rate to induce pneumoperitoneum followed by high flow rate to maintain the pressure provides advantages to reduce the severity of shoulder pain for patients who underwent LC and then experienced shoulder pain.",2019,"The incidence of shoulder pain was not significantly different (group A 45.7% vs group B 48.6%, p = 0.866).","['140 patients to evaluate the efficacy of low flow rate (1\xa0L/min) for induction followed by high flow rate (10\xa0L/min) for maintaining 12\xa0mmHg pneumoperitoneum (group A, n\u2009=\u200970) during', 'Shoulder Pain']","['Laparoscopic Insufflation Rate', 'laparoscopic cholecystectomy (LC']","['10-visual analog scale (VAS', 'severity of shoulder pain', 'pain scores', 'incidence of shoulder pain', 'operative time, occurrence of bradycardia, or hospital stay']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439393', 'cui_str': 'liter/minute'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}]","[{'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",140.0,0.0691972,"The incidence of shoulder pain was not significantly different (group A 45.7% vs group B 48.6%, p = 0.866).","[{'ForeName': 'Kuo-Feng', 'Initials': 'KF', 'LastName': 'Hsu', 'Affiliation': 'Division of General Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, No. 325, Sec. 2, Cheng-Kung Road, Neihu, 114, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Jueng', 'Initials': 'CJ', 'LastName': 'Chen', 'Affiliation': 'Division of General Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, No. 325, Sec. 2, Cheng-Kung Road, Neihu, 114, Taipei, Taiwan. doc20227@tsghms.ndmctsgh.edu.tw.'}, {'ForeName': 'Jyh-Cherng', 'Initials': 'JC', 'LastName': 'Yu', 'Affiliation': 'Division of General Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, No. 325, Sec. 2, Cheng-Kung Road, Neihu, 114, Taipei, Taiwan.'}, {'ForeName': 'Si-Yuan', 'Initials': 'SY', 'LastName': 'Wu', 'Affiliation': 'Division of General Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, No. 325, Sec. 2, Cheng-Kung Road, Neihu, 114, Taipei, Taiwan.'}, {'ForeName': 'Bao-Chung', 'Initials': 'BC', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Yang', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Teng-Wei', 'Initials': 'TW', 'LastName': 'Chen', 'Affiliation': 'Division of General Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, No. 325, Sec. 2, Cheng-Kung Road, Neihu, 114, Taipei, Taiwan.'}, {'ForeName': 'Chung-Bao', 'Initials': 'CB', 'LastName': 'Hsieh', 'Affiliation': 'Division of General Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, No. 325, Sec. 2, Cheng-Kung Road, Neihu, 114, Taipei, Taiwan.'}, {'ForeName': 'De-Chuan', 'Initials': 'DC', 'LastName': 'Chan', 'Affiliation': 'Division of General Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, No. 325, Sec. 2, Cheng-Kung Road, Neihu, 114, Taipei, Taiwan. chrischan1168@yahoo.com.tw.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-018-3896-5']
857,29624543,INJECTION FREQUENCY OF AFLIBERCEPT VERSUS RANIBIZUMAB IN A TREAT-AND-EXTEND REGIMEN FOR CENTRAL RETINAL VEIN OCCLUSION: A Randomized Clinical Trial.,"PURPOSE


To prospectively investigate the injection frequency of aflibercept and ranibizumab in the treatment of macular edema in central retinal vein occlusion.
METHODS


Patients with treatment-naive central retinal vein occlusion and macular edema were randomized to receive intravitreal injections with aflibercept (n = 22) or ranibizumab (n = 23) in a treat-and-extend regimen with a follow-up time of 18 months. After 3 loading doses, the treatment intervals were extended by 2 weeks to a maximum of 12 weeks. Intervals were shortened by 2 weeks if macular edema recurred.
RESULTS


The number of injections was significantly lower in the aflibercept group with a mean of 10.9 injections (95% confidence interval, 9.6-12.3) compared with 14.4 in the ranibizumab group (95% confidence interval 12.7-16.1) at study completion (P = 0.0017). The mean treatment interval was significantly longer in the aflibercept group compared with the ranibizumab group 10.0 (95% confidence interval, 8.7-11.3) and 6.6 (95% confidence interval, 5.2-8.0) weeks, respectively (P < 0.001). No significant difference between the groups regarding visual acuity or central retinal thickness was observed.
CONCLUSION


Patients with macular edema secondary to central retinal vein occlusion required significantly fewer intravitreal injections of aflibercept compared with ranibizumab when treated with a treat-and-extend regimen. This may reduce the treatment burden and, to some extent, the need for close monitoring of patients.",2019,"The mean treatment interval was significantly longer in the aflibercept group compared with the ranibizumab group 10.0 (95% confidence interval, 8.7-11.3) and 6.6 (95% confidence interval, 5.2-8.0) weeks, respectively (P < 0.001).","['Patients with macular edema secondary to central retinal vein occlusion', 'macular edema in central retinal vein occlusion', 'Patients with treatment-naive central retinal vein occlusion and macular edema']","['aflibercept and ranibizumab', 'intravitreal injections with aflibercept', 'aflibercept', 'OF AFLIBERCEPT VERSUS RANIBIZUMAB', 'ranibizumab']","['visual acuity or central retinal thickness', 'mean treatment interval', 'number of injections']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0271051', 'cui_str': 'Macular Edema'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0154841', 'cui_str': 'Central retinal vein occlusion (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]",,0.301596,"The mean treatment interval was significantly longer in the aflibercept group compared with the ranibizumab group 10.0 (95% confidence interval, 8.7-11.3) and 6.6 (95% confidence interval, 5.2-8.0) weeks, respectively (P < 0.001).","[{'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Casselholm de Salles', 'Affiliation': 'Karolinska Institutet, St. Erik Eye Hospital, Stockholm, Sweden.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Amrén', 'Affiliation': ''}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kvanta', 'Affiliation': ''}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Epstein', 'Affiliation': ''}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002171']
858,31852811,"Intergroup Randomized Phase III Study of Postoperative Oxaliplatin, 5-Fluorouracil, and Leucovorin Versus Oxaliplatin, 5-Fluorouracil, Leucovorin, and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Preoperative Chemoradiation: A Trial of the ECOG-ACRIN Research Group (E5204).","BACKGROUND


The addition of bevacizumab to chemotherapy improved outcomes for patients with metastatic colon cancer. E5204 was designed to test whether the addition of bevacizumab to mFOLFOX6, following neoadjuvant chemoradiation and definitive surgery, could improve overall survival (OS) in patients with stage II/III adenocarcinoma of the rectum.
SUBJECTS, MATERIALS, AND METHODS


Patients with stage II/III rectal cancer who had completed neoadjuvant 5-fluorouracil-based chemoradiation and had undergone complete resection were enrolled. Patients were randomized to mFOLFOX6 (Arm A) or mFOLFOX6 with bevacizumab (Arm B) administered every 2 weeks for 12 cycles.
RESULTS


E5204 registered only 355 patients (17% of planned accrual goal) as it was terminated prematurely owing to poor accrual. At a median follow-up of 72 months, there was no difference in 5-year overall survival (88.3% vs. 83.7%) or 5-year disease-free survival (71.2% vs. 76.5%) between the two arms. The rate of treatment-related grade ≥ 3 adverse events (AEs) was 68.8% on Arm A and 70.7% on Arm B. Arm B had a higher proportion of patients who discontinued therapy early as a result of AEs and patient withdrawal than did Arm A (32.4% vs. 21.5%, p = .029).The most common grade 3-4 treatment-related AEs were neutropenia, leukopenia, neuropathy, diarrhea (without prior colostomy), and fatigue.
CONCLUSION


At 17% of its planned accrual, E5204 did not meet its primary endpoint. The addition of bevacizumab to FOLFOX6 in the adjuvant setting did not significantly improve OS in patients with stage II/III rectal cancer.
IMPLICATIONS FOR PRACTICE


At 17% of its planned accrual, E5204 was terminated early owing to poor accrual. At a median follow-up of 72 months, there was no significant difference in 5-year overall survival (88.3% vs. 83.7%) or in 5-year disease-free survival (71.2% vs. 76.5%) between the two arms. Despite significant advances in the treatment of rectal cancer, especially in improving local control rates, the risk of distant metastases and the need to further improve quality of life remain a challenge. Strategies combining novel agents with chemoradiation to improve both distant and local control are needed.",2020,"The rate of treatment-related grade ≥ 3 adverse events (AEs) was 68.8% on Arm A and 70.7% on Arm B. Arm B had a higher proportion of patients who discontinued therapy early as a result of AEs and patient withdrawal than did Arm A (32.4% vs. 21.5%,  ","['patients with stage II/III rectal cancer', 'patients with stage II/III adenocarcinoma of the rectum', 'patients with metastatic colon cancer', 'Patients with stage II/III rectal cancer who had completed neoadjuvant 5-fluorouracil-based chemoradiation and had undergone complete resection were enrolled', 'Patients with Stage II or III Rectal Cancer Receiving Preoperative Chemoradiation']","['bevacizumab', 'mFOLFOX6', 'Postoperative Oxaliplatin, 5-Fluorouracil, and Leucovorin Versus Oxaliplatin, 5-Fluorouracil, Leucovorin, and Bevacizumab', 'bevacizumab to mFOLFOX6, following neoadjuvant chemoradiation and definitive surgery', 'mFOLFOX6 with bevacizumab']","['rate of treatment-related grade ≥\u20093 adverse events (AEs', 'OS', '5-year disease-free survival', 'overall survival (OS', 'neutropenia, leukopenia, neuropathy, diarrhea (without prior colostomy), and fatigue', '5-year overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0278484', 'cui_str': 'Colon cancer Dukes D'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443196', 'cui_str': 'Definitive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009410', 'cui_str': 'Colostomy'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",355.0,0.170331,"The rate of treatment-related grade ≥ 3 adverse events (AEs) was 68.8% on Arm A and 70.7% on Arm B. Arm B had a higher proportion of patients who discontinued therapy early as a result of AEs and patient withdrawal than did Arm A (32.4% vs. 21.5%,  ","[{'ForeName': 'A Bapsi', 'Initials': 'AB', 'LastName': 'Chakravarthy', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Fengmin', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': 'ECOG-ACRIN Biostatistics Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Neal J', 'Initials': 'NJ', 'LastName': 'Meropol', 'Affiliation': 'Flatiron Health, New York, New York, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Flynn', 'Affiliation': 'Abbott-Northwestern Hospital, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Lynne I', 'Initials': 'LI', 'LastName': 'Wagner', 'Affiliation': 'Wake Forest University Health Sciences, Winston Salem, North Carolina, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Sloan', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Diasio', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Edith P', 'Initials': 'EP', 'LastName': 'Mitchell', 'Affiliation': 'Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Catalano', 'Affiliation': 'ECOG-ACRIN Biostatistics Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Giantonio', 'Affiliation': 'Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Catalano', 'Affiliation': 'Drexel University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Haller', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Rashid A', 'Initials': 'RA', 'LastName': 'Awan', 'Affiliation': 'University of Pittsburgh Cancer Institute (UPCI), Johnstown, Pennsylvania, USA.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Mulcahy', 'Affiliation': 'Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': ""O'Brien"", 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Santala', 'Affiliation': 'Montana Cancer Consortium, Billings, Montana, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cripps', 'Affiliation': 'Ottawa Health Research Institute-General Division, Ottawa, Ontario, Canada.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Weis', 'Affiliation': 'Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Atkins', 'Affiliation': 'Southeast Cancer Control Consortium, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Cynthia G', 'Initials': 'CG', 'LastName': 'Leichman', 'Affiliation': 'Laura and Issac Perlmutter Cancer Center at NYU Langone, New York, New York, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Petrelli', 'Affiliation': 'Delaware/Christiana Care NCORP, Newark, Delaware, USA.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Sinicrope', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Brierley', 'Affiliation': 'University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Tepper', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': ""O'Dwyer"", 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Elin R', 'Initials': 'ER', 'LastName': 'Sigurdson', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Stanley R', 'Initials': 'SR', 'LastName': 'Hamilton', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Al B', 'Initials': 'AB', 'LastName': 'Benson', 'Affiliation': 'Northwestern University, Chicago, Illinois, USA.'}]",The oncologist,['10.1634/theoncologist.2019-0437']
859,29666023,The influence of lens care systems on eyelid tissue changes during silicone hydrogel contact lens wear.,"PURPOSE


To compare the effects of a hydrogen peroxide (H 2 O 2 )-based lens care solution and a polyhexamethylene biguanide (PHMB) multi-purpose solution on the eyelids when used with silicone hydrogel (SiHy) contact lenses.
METHODS


A total of 74 symptomatic wearers of ACUVUE ®  OASYS ®  (senofilcon A; n = 39) or PureVision ®  (balafilcon A; n = 35) contact lenses were randomised 1:1 to either CLEAR CARE ®  Cleaning & Disinfecting Solution or renu ®  fresh™ multi-purpose solution (n = 37 each). Assessments of hyperaemia, papillae and lid margin staining of eyelid tissue were evaluated subjectively by a masked investigator at enrolment (with the subjects' habitual SiHy contact lenses and PHMB-preserved care systems), at dispensing visit (when no lenses were worn) and at 3-months' follow-up.
RESULTS


There were no differences in eyelid assessments between the two lens care groups at dispensing visit (p = 0.086 to 0.947). After 3 months, the papillae response was significantly less marked with H2O2-based solution than with PHMB-based solution (p = 0.017). Lid hyperaemia (p < 0.001) and papillae (p = 0.002) were also significantly reduced. Although lid hyperaemia was also reduced with PHMB-based solution (p < 0.001), there was no concurrent decrease in papillae response (p = 0.051). No improvements were found in eyelid margin staining either over time or between the two lens care groups.
CONCLUSION


In symptomatic contact lens wearers, a H 2 O 2 -based lens care solution used with senofilcon A and balafilcon A lenses was better tolerated by eyelid tissues than was a PHMB-based solution and led to a decrease in clinical markers of eyelid inflammation.",2018,"After 3 months, the papillae response was significantly less marked with H2O2-based solution than with PHMB-based solution (p = 0.017).",['74 symptomatic wearers of ACUVUE ®  OASYS ®  (senofilcon A; n\u202f=\u202f39) or PureVision ®  (balafilcon A; n\u202f=\u202f35) contact lenses'],"['silicone hydrogel contact lens wear', 'silicone hydrogel (SiHy) contact lenses', 'CLEAR CARE ®  Cleaning & Disinfecting Solution or renu ®  fresh™ multi-purpose solution', 'hydrogen peroxide (H 2 O 2 )-based lens care solution and a polyhexamethylene biguanide (PHMB) multi-purpose solution', 'senofilcon A and balafilcon A lenses']","['clinical markers of eyelid inflammation', 'eyelid tissue changes', 'Assessments of hyperaemia, papillae and lid margin staining of eyelid tissue', 'eyelid assessments', 'lid hyperaemia', 'papillae response', 'eyelid margin staining', 'Lid hyperaemia']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2002497', 'cui_str': 'senofilcon A'}, {'cui': 'C2002496', 'cui_str': 'balafilcon A'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel, Polyethylene Glycol Dimethacrylate'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023317', 'cui_str': 'Lens, Eye'}, {'cui': 'C0376892', 'cui_str': 'polihexanide'}, {'cui': 'C2002497', 'cui_str': 'senofilcon A'}, {'cui': 'C2002496', 'cui_str': 'balafilcon A'}, {'cui': 'C0023318', 'cui_str': 'Lenses'}]","[{'cui': 'C0008963', 'cui_str': 'Markers, Clinical'}, {'cui': 'C0005741', 'cui_str': 'Blepharitis'}, {'cui': 'C0015426', 'cui_str': 'Eyelids'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0444582', 'cui_str': 'Structure of free margin of eyelid'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}]",74.0,0.0453254,"After 3 months, the papillae response was significantly less marked with H2O2-based solution than with PHMB-based solution (p = 0.017).","[{'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Guillon', 'Affiliation': 'Ocular Technology Group- International, London, UK; School of Life and Health Science, Aston University, Birmingham, UK. Electronic address: mguillon@otg.co.uk.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Maissa', 'Affiliation': 'School of Life and Health Science, Aston University, Birmingham, UK; Alcon Research, Ltd., Johns Creek, GA, USA.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Ocular Technology Group- International, London, UK.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Patel', 'Affiliation': 'Ocular Technology Group- International, London, UK.'}, {'ForeName': 'Renée', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': 'Alcon Research, Ltd., Fort Worth, TX, USA.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2018.02.141']
860,29642095,"Efficacy of Intra-articular Polynucleotides Associated With Hyaluronic Acid Versus Hyaluronic Acid Alone in the Treatment of Knee Osteoarthritis: A Randomized, Double-Blind, Controlled Clinical Trial.","OBJECTIVE


Pain and range of motion loss are the main clinical features of osteoarthritis (OA). Hyaluronic acid (HA) is one of the infiltrative therapies for OA treatment; however, its effectiveness is a matter of an ongoing debate in clinical practice. Polynucleotides (PNs), a DNA-derived macromolecule with natural origin and trophic activity, were found to favor cell growth and collagen production, in preclinical and clinical studies regarding cartilage regeneration. This study aimed at evaluating whether injection of PNs, in combination with HA [PNs associated with HA (PNHA)], can ameliorate pain and function of knees affected by OA, more than HA alone.
DESIGN


A randomized, double-blind, controlled clinical trial.
PATIENTS


The study enrolled 100 patients, then randomized to receive PNHA or HA alone (3 weekly knee I.A. injections).
INTERVENTIONS AND MAIN OUTCOME MEASURES


Pain reduction, decrease of proinflammatory synovial fluid (SF) factors, and improvement in knee function were evaluated by Knee Society Score and WOMAC scores, after 2, 6, and 12 months and by biochemical and immunoenzymatic analyses of SF at the end of the treatment.
RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group. A significant reduction in the WOMAC score was observed over time for both groups. No significant adverse events were reported in either group.
CONCLUSIONS


These findings suggest that I.A. injection of PNs, in combination with HA, is more effective in improving knee function and pain, in a joint affected by OA, compared with HA alone.",2018,"RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group.","['Knee Osteoarthritis', '100 patients']","['HA [PNs associated with HA (PNHA', 'Hyaluronic acid (HA', 'PNHA or HA alone', 'Hyaluronic Acid Versus Hyaluronic Acid Alone']","['Knee Society Score total score and pain item', 'knee function and pain', 'adverse events', 'WOMAC score', 'Knee Society Score and WOMAC scores', 'Pain reduction, decrease of proinflammatory synovial fluid (SF) factors, and improvement in knee function']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0039097', 'cui_str': 'Synovia'}]",100.0,0.245541,"RESULTS


Knee Society Score total score and pain item significantly ameliorated in both groups, showing better results in PNHA- than in the HA-treated group.","[{'ForeName': 'Dante', 'Initials': 'D', 'LastName': 'Dallari', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Sabbioni', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Nicolandrea', 'Initials': 'N', 'LastName': 'Del Piccolo', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Carubbi', 'Affiliation': 'Conservative Orthopedic Surgery and Innovative Techniques, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Veronesi', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Torricelli', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}, {'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Fini', 'Affiliation': 'Laboratory of Preclinical and Surgical Studies, Rizzoli Orthopedic Institute, Bologna, Italy.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000569']
861,29576438,Light disturbance with multifocal contact lens and monovision for presbyopia.,"Dysphotopsia affects a significant number of patients, particularly after visual correction with multifocal optical designs.
PURPOSE


Evaluate light distortion (LD) in two modalities of contact lens (CL) wear: multifocal (MF) and monofocal (MV).
METHODS


This was a randomized, double-masked, crossover study involving 20 presbyopic patients. Patients were randomized first into either MF or MV for 15 days of use with a 1 week wash-out period between each lens type. The LD was evaluated with the Light Distortion Analyzer (LDA, University of Minho) under monocular and binocular conditions. The light distortion index (LDI, %), among other parameters were analyzed. Subjective quality of vision was assessed with the Quality of Vision (QoV).
RESULTS


The LD showed an increase in all parameters in both CL modalities being significant for MV in the non-dominant eye (p < 0.030, for all LD parameters). For the MF, there was also a significant increase in LDI (p = 0.016) and in BFCrad (p = 0.022) in the non-dominant eye. After 15 days of MF lens wear, there was a significant decrease in all LD parameters (p < 0.002) in the dominant eye. Binocularly, a significant improvement from 1 to 15 days was observed for LDI (p = 0.009) and BFCrad (p = 0.0013) with MF. The QoV questionnaire showed no significant changes with neither CL.
CONCLUSIONS


Adaptation to light disturbances induced by MF CL is more effective compared to MV. Practitioners will have greater success if they prepare their patients for the adaptation required as their vision will get better and have less of an issue with light disturbance.",2018,"Binocularly, a significant improvement from 1 to 15 days was observed for LDI (p = 0.009) and BFCrad (p = 0.0013) with MF.",['20 presbyopic patients'],"['light distortion (LD', 'MF or MV']","['Quality of Vision (QoV', 'all LD parameters', 'LDI', 'Subjective quality of vision']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0332482', 'cui_str': 'Abnormal shape'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",20.0,0.0308422,"Binocularly, a significant improvement from 1 to 15 days was observed for LDI (p = 0.009) and BFCrad (p = 0.0013) with MF.","[{'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Fernandes', 'Affiliation': 'Clinical and Experimental Optometry Research Laboratory (CEORLab) Center of Physics (Optometry), School of Sciences, University of Minho, Braga, Portugal. Electronic address: pfernandes@fisica.uminho.pt.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Amorim-de-Sousa', 'Affiliation': 'Clinical and Experimental Optometry Research Laboratory (CEORLab) Center of Physics (Optometry), School of Sciences, University of Minho, Braga, Portugal.'}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Queirós', 'Affiliation': 'Clinical and Experimental Optometry Research Laboratory (CEORLab) Center of Physics (Optometry), School of Sciences, University of Minho, Braga, Portugal.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Escandón-Garcia', 'Affiliation': 'Clinical and Experimental Optometry Research Laboratory (CEORLab) Center of Physics (Optometry), School of Sciences, University of Minho, Braga, Portugal.'}, {'ForeName': 'Colm', 'Initials': 'C', 'LastName': 'McAlinden', 'Affiliation': 'University Hospitals Bristol, NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'González-Méijome', 'Affiliation': 'Clinical and Experimental Optometry Research Laboratory (CEORLab) Center of Physics (Optometry), School of Sciences, University of Minho, Braga, Portugal.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2018.03.006']
862,29244528,"Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE.","Purpose Human epidermal growth factor receptor 2 (HER2) targeting plus endocrine therapy (ET) improved clinical benefit in HER2-positive, hormone receptor (HR)-positive metastatic breast cancer (MBC) versus ET alone. Dual HER2 blockade enhances clinical benefit versus single HER2 blockade. The ALTERNATIVE study evaluated the efficacy and safety of dual HER2 blockade plus aromatase inhibitor (AI) in postmenopausal women with HER2-positive/HR-positive MBC who received prior ET and prior neo(adjuvant)/first-line trastuzumab (TRAS) plus chemotherapy. Methods Patients were randomly assigned (1:1:1) to receive lapatinib (LAP) + TRAS + AI, TRAS + AI, or LAP + AI. Patients for whom chemotherapy was intended were excluded. The primary end point was progression-free survival (PFS; investigator assessed) with LAP + TRAS + AI versus TRAS + AI. Secondary end points were PFS (comparison of other arms), overall survival, overall response rate, clinical benefit rate, and safety. Results Three hundred fifty-five patients were included in this analysis: LAP + TRAS + AI (n = 120), TRAS + AI (n = 117), and LAP + AI (n = 118). Baseline characteristics were balanced. The study met its primary end point; superior PFS was observed with LAP + TRAS + AI versus TRAS + AI (median PFS, 11 v 5.7 months; hazard ratio, 0.62; 95% CI, 0.45 to 0.88; P = .0064). Consistent PFS benefit was observed in predefined subgroups. Overall response rate, clinical benefit rate, and overall survival also favored LAP + TRAS + AI. The median PFS with LAP + AI versus TRAS + AI was 8.3 versus 5.7 months (hazard ratio, 0.71; 95% CI, 0.51 to 0.98; P = .0361). Common adverse events (AEs; ≥ 15%) with LAP + TRAS + AI, TRAS + AI, and LAP + AI were diarrhea (69%, 9%, and 51%, respectively), rash (36%, 2%, and 28%, respectively), nausea (22%, 9%, and 22%, respectively), and paronychia (30%, 0%, and 15%, respectively), mostly grade 1 or 2. Serious AEs were reported similarly across the three groups, and AEs leading to discontinuation were lower with LAP + TRAS + AI. Conclusion Dual HER2 blockade with LAP + TRAS + AI showed superior PFS benefit versus TRAS + AI in patients with HER2-positive/HR-positive MBC. This combination offers an effective and safe chemotherapy-sparing alternative treatment regimen for this patient population.",2018,"Serious AEs were reported similarly across the three groups, and AEs leading to discontinuation were lower with LAP + TRAS + AI.","['Postmenopausal Women', 'postmenopausal women with HER2-positive/HR-positive MBC who received prior', 'Results Three hundred fifty-five patients were included in this analysis', 'patients with HER2-positive/HR-positive MBC']","['Dual HER2 blockade', 'Blockade With Lapatinib Plus Trastuzumab', 'dual HER2 blockade plus aromatase inhibitor (AI', 'LAP + TRAS + AI versus TRAS + AI', 'LAP + TRAS + AI', 'Human epidermal growth factor receptor 2 (HER2) targeting plus endocrine therapy (ET', 'lapatinib (LAP) + TRAS + AI, TRAS + AI, or LAP + AI', 'TRAS + AI', 'ET and prior neo(adjuvant)/first-line trastuzumab (TRAS) plus chemotherapy', 'Dual Human Epidermal Growth Factor Receptor 2 (HER2']","['PFS (comparison of other arms), overall survival, overall response rate, clinical benefit rate, and safety', 'Overall response rate, clinical benefit rate, and overall survival', 'diarrhea', 'progression-free survival', 'paronychia', 'superior PFS', 'median PFS', 'nausea', 'rash']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0450382', 'cui_str': '55 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}]",355.0,0.0970516,"Serious AEs were reported similarly across the three groups, and AEs leading to discontinuation were lower with LAP + TRAS + AI.","[{'ForeName': 'Stephen R D', 'Initials': 'SRD', 'LastName': 'Johnston', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'In Hae', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Burdaeva', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Kurteva', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Press', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Sergei', 'Initials': 'S', 'LastName': 'Tjulandin', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Sergio D', 'Initials': 'SD', 'LastName': 'Simon', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kenny', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Sarp', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Izquierdo', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Williams', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Gradishar', 'Affiliation': 'Stephen R.D. Johnston, The Royal Marsden NHS Foundation Trust, London; Lisa S. Williams, Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom; Roberto Hegg, Centro de Referência da Saúde da Mulher; Sergio D. Simon, Hospital Israelita Albert Einstein, São Paulo, Brazil; Seock-Ah Im, Seoul National University College of Medicine, Seoul; In Hae Park, National Cancer Center, Gyeonggi-do, Korea; Olga Burdaeva, Regional Oncology Dispensary, Arkhangelsk; Sergei Tjulandin, N.N. Blokhin Russian Cancer Research Center, Moscow, Russia; Galina Kurteva, University Cancer Center Hospital, Sofia, Bulgaria; Michael F. Press, University of Southern California, Los Angeles, CA; Hiroji Iwata, Aichi Cancer Center Hospital, Aichi, Japan; Sarah Kenny, Severine Sarp, and Miguel A. Izquierdo, Novartis Pharma AG, Basel, Switzerland; and William J. Gradishar, Northwestern University, Chicago, IL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.2017.74.7824']
863,31518440,Clinical evaluation of injectable platelet-rich fibrin with connective tissue graft for the treatment of deep gingival recession defects: A controlled randomized clinical trial.,"AIM


The aim of this study was to determine whether the combined connective tissue graft (CTG) with injectable platelet-rich fibrin (i-PRF) with coronally advanced flap (CAF) improved root coverage of deep Miller Class I or II gingival recessions compared with CTG alone with CAF.
MATERIAL AND METHODS


Seventy-two patients with Miller class I and II gingival recessions were enrolled. Thirty-six patients were randomly assigned to the test group (CAF+CTG+i-PRF [700 rpm for 3 min]) or control group (CAF+CTG). Clinical evaluations were made at 6 months.
RESULTS


At 6 months, complete root coverage was obtained at 88% of the sites treated with CAF+CTG+i-PRF and 80% of the sites treated with CAF+CTG. Difference between the two groups was not statistically significant. At 6 months, the recession depth (RD) reduction and increase in keratinized tissue height (KTH) of the test sites were significantly better compared with the control sites.
CONCLUSIONS


According to the results, the addition of i-PRF to the CAF+CTG treatment showed further development in terms of increasing the KTH and decreasing RD. However, this single trial is not sufficient to advocate the true clinical effect of i-PRF on recession treatment with CAF+CTG and additional trials are needed.",2020,"At 6 months, complete root coverage was obtained at 88% of the sites treated with CAF+CTG+i-prf and 80% of the sites treated with CAF+CTG.","['deep gingival recession defects', 'Seventy-two patients with Miller class I and II gingival recessions were enrolled', 'Thirty-six patients']","['test group [CAF+CTG+i-prf (700rpm for 3min)] or control group [CAF+CTG', 'combined connective tissue graft (CTG) with injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF', 'CAF+CTG', 'CTG alone with CAF', 'injectable platelet rich fibrin with connective tissue graft']","['recession depth (RD) reduction and increase in keratinized tissue height (KTH', 'complete root coverage', 'KTH and decreasing RD']","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0017572', 'cui_str': 'Gingival Recession'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0402830', 'cui_str': 'Miller (occupation)'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0009780', 'cui_str': 'Connective Tissue'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C4505052', 'cui_str': 'L-PRF'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}]","[{'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",72.0,0.0274785,"At 6 months, complete root coverage was obtained at 88% of the sites treated with CAF+CTG+i-prf and 80% of the sites treated with CAF+CTG.","[{'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Ucak Turer', 'Affiliation': 'Department of Periodontology, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Ozcan', 'Affiliation': 'Department of Periodontology, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Alkaya', 'Affiliation': 'Department of Periodontology, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Seren', 'Initials': 'S', 'LastName': 'Surmeli', 'Affiliation': 'Department of Periodontology, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Gulsah', 'Initials': 'G', 'LastName': 'Seydaoglu', 'Affiliation': 'Department of Biostatistics, Cukurova University, Adana, Turkey.'}, {'ForeName': 'Mehmet Cenk', 'Initials': 'MC', 'LastName': 'Haytac', 'Affiliation': 'Department of Periodontology, Cukurova University, Adana, Turkey.'}]",Journal of clinical periodontology,['10.1111/jcpe.13193']
864,31623851,Altruistic self-regulation in young children.,"We investigated whether children would be willing to sustain delaying their own gratification in order to benefit someone else. We used a modified version of the classic ""marshmallow task,"" in which children must sustain delaying gratification in the presence of the immediate reward for an unspecified amount of time in order to receive a larger reward later. Children were assigned to one of three conditions. In the Self condition, children were given a food item and were told that if they waited to eat it, they would receive a second food item. In the Prosocial condition, children also were given a food item but were told that if they waited to eat their food item, another child would get a food item. In the Nonsocial Control condition, children were given a food item but were told that waiting to eat it would not benefit anyone. We found that children waited significantly longer in both the Self and Prosocial conditions than in the Nonsocial Control condition, and children's wait durations in the Self and Prosocial conditions were not significantly different. Our results suggest that children are willing to engage in effortful self-regulation in order to benefit another child.",2020,"We found that children waited significantly longer in both the Self and Prosocial conditions than in the Nonsocial Control condition, and children's wait durations in the Self and Prosocial conditions were not significantly different.",['young children'],[],[],"[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]",[],[],,0.0217907,"We found that children waited significantly longer in both the Self and Prosocial conditions than in the Nonsocial Control condition, and children's wait durations in the Self and Prosocial conditions were not significantly different.","[{'ForeName': 'Rinatte L', 'Initials': 'RL', 'LastName': 'Gruen', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, FL 33124, USA.'}, {'ForeName': 'Shiba M', 'Initials': 'SM', 'LastName': 'Esfand', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA 02215, USA.'}, {'ForeName': 'Melissa M', 'Initials': 'MM', 'LastName': 'Kibbe', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, MA 02215, USA; Center for Systems Neuroscience, Boston University, Boston, MA 02215, USA. Electronic address: kibbe@bu.edu.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.104700']
865,31612327,Pain and quality of life after endodontic surgery with or without advanced platelet-rich fibrin membrane application: a randomized clinical trial.,"BACKGROUND


Clinical evidence of the autologous platelet concentrates effects on the patient-reported outcome measures (PROMs) after endodontic surgery is still limited.
OBJECTIVES


To investigate the effect of the advanced platelet-rich fibrin (A-PRF+) membrane application upon patient postoperative pain, and quality of life in endodontic surgery.
MATERIALS AND METHODS


A two-parallel-arm randomized clinical trial was made comparing endodontic surgery with or without A-PRF+ as adjunctive treatment. Fifty individuals comprehending 50 apical lesions (second premolar to the second premolar) of upper maxilla were included. Pain perception and quality of life (functional limitations and other symptoms) were assessed 1 week after surgery using a visual analog scale and a Likert scale-based questionnaire. Descriptive analysis was done using χ 2  and t test. Binary logistic regression, ANOVA-type statistic, and GEE analysis were used for inferential analysis.
RESULTS


Pain perception was mild in both groups [A-PRF+ 12.7 ± 8.5] versus [no A-PRF+ 20.7 ± 16.3]; it proved less variable during the first 4 days in test group, showing lower extreme pain values (p = 0.096). Analgesic use was similar in both groups. Controls reported significantly worse sleep and speech functions (p < 0.05). Bleeding and bad taste/breath were the most discriminative symptoms.
CONCLUSIONS


Postoperative pain perception was mild in endodontic surgery of the upper anterior maxilla. Differences in pain perception were not statistically significant. The use of A-PRF+ afforded less variable pain perception than in the controls. Altered quality of life parameters were more prevalent in the control group and prove significant for speech and sleep functions.
CLINICAL RELEVANCE


Patient-related outcomes are of utmost importance in clinical practice. The use of A-PRF+ provides an affordable and safe alternative to improve postoperative quality of life in endodontic surgery.",2020,Controls reported significantly worse sleep and speech functions (p < 0.05).,['Fifty individuals comprehending 50 apical lesions (second premolar to the second premolar) of upper maxilla were included'],"['endodontic surgery with or without A-PRF', 'advanced platelet-rich fibrin (A-PRF+) membrane application', 'endodontic surgery with or without advanced platelet-rich fibrin membrane application']","['extreme pain values', 'Altered quality of life parameters', 'Pain perception', 'Bleeding and bad taste/breath', 'speech and sleep functions', 'variable pain perception', 'patient postoperative pain, and quality of life', 'pain perception', 'Pain perception and quality of life (functional limitations and other symptoms', 'Analgesic use', 'postoperative quality of life', 'Pain and quality of life', 'sleep and speech functions']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0024947', 'cui_str': 'Maxillary Bone'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0700632', 'cui_str': 'Endodontic procedure (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4505052', 'cui_str': 'L-PRF'}, {'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0034380'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",50.0,0.158679,Controls reported significantly worse sleep and speech functions (p < 0.05).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Soto-Peñaloza', 'Affiliation': 'Oral Surgery Unit, Department of Stomatology, Faculty of Medicine and Dentistry, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Peñarrocha-Diago', 'Affiliation': 'Oral Surgery Unit, Department of Stomatology, Faculty of Medicine and Dentistry, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Cervera-Ballester', 'Affiliation': 'Department of Stomatology, Faculty of Medicine and Dentistry, University of Valencia, Valencia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Peñarrocha-Diago', 'Affiliation': 'Oral Surgery Unit, Department of Stomatology, Faculty of Medicine and Dentistry, University of Valencia, Valencia, Spain. maria.penarrocha@uv.es.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Tarazona-Alvarez', 'Affiliation': 'Department of Stomatology, Faculty of Medicine and Dentistry, University of Valencia, Valencia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peñarrocha-Oltra', 'Affiliation': 'Oral Surgery Unit, Department of Stomatology, Faculty of Medicine and Dentistry, University of Valencia, Valencia, Spain.'}]",Clinical oral investigations,['10.1007/s00784-019-03033-5']
866,31501226,"Heart Rate Variability and Cardiac Autonomic Dysfunction: Prevalence, Risk Factors, and Relationship to Arterial Stiffness in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study.","OBJECTIVE


To determine whether prior type 2 diabetes (T2D) treatment or glycemic control over time are independently associated with heart rate variability (HRV) and whether the presence of cardiac autonomic dysfunction is associated with arterial stiffness in young adults with youth-onset T2D enrolled in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study.
RESEARCH DESIGN AND METHODS


Heartbeats over 10 min were measured to derive the normal R-Rs (NN intervals). Outcomes included the standard deviation of the NN intervals (SDNN), the root mean square differences of successive NN intervals (RMSSD), percent of NN beats that differ by more than 50 ms (PNN50), and the low-frequency (LF) power domain, high-frequency (HF) power domain, and their ratio (LF:HF). Autonomic dysfunction was defined as ≥3 of 5 abnormal HRV indices compared with obese controls from a separate study.
RESULTS


A total of 397 TODAY participants were evaluated 7 years after randomization. TODAY participants had reduced HRV (SDNN 58.1 ± 29.6 ms vs. controls 67.1 ± 25.4 ms;  P  < 0.0001) with parasympathetic loss (RMSSD 53.2 ± 36.7 ms vs. controls 67.9 ± 35.2 ms;  P  < 0.0001) with sympathetic overdrive (LF:HF ratio 1.4 ± 1.7 vs. controls 1.0 ± 1.1;  P  < 0.0001). Cardiac autonomic dysfunction was present in 8% of TODAY participants, and these participants had greater pulse wave velocity compared with those without dysfunction ( P  = 0.0001). HRV did not differ by randomized treatment, but higher hemoglobin A1c (HbA 1c ) over time was independently associated with lower SDNN and RMSSD and higher LF:HF ratio after adjustment for age, race-ethnicity, sex, and BMI.
CONCLUSIONS


Young adults with youth-onset T2D show evidence of cardiac autonomic dysfunction with both parasympathetic and sympathetic impairments that are associated with higher HbA 1c .",2019,TODAY participants had reduced HRV (SDNN; 57.9 ± 29.6 ms vs. controls 67.1 ± 25.4 ms;  P  < 0.0001) with parasympathetic loss (RMSSD; 53.0 ± 36.6 ms vs. controls 67.9 ± 35.2 ms;  P  < 0.0001) with sympathetic overdrive (LF:HF ratio; 1.4 ± 1.7 vs. controls 1.0 ± 1.1;  P  < 0.0001).,"['A total of 397 TODAY participants were evaluated 7 years after randomization', 'Young adults with youth-onset T2D', 'young adults with youth-onset T2D enrolled in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study']","['LF', 'prior type 2 diabetes (T2D) treatment or glycemic control']","['HF ratio', 'Autonomic dysfunction', 'heart rate variability (HRV', 'parasympathetic loss', 'HRV', 'standard deviation of the NN intervals (SDNN), the root mean square differences of successive NN intervals (RMSSD), percent of NN beats that differ by more than 50 ms (PNN50), and the low-frequency (LF) power domain, high-frequency (HF) power domain, and their ratio (LF:HF', 'Heart Rate Variability and Cardiac Autonomic Dysfunction', 'Cardiac autonomic dysfunction', 'hemoglobin A1c (HbA 1c ) over time']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1145628', 'cui_str': 'Central Autonomic Nervous System Diseases'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",397.0,0.0563142,TODAY participants had reduced HRV (SDNN; 57.9 ± 29.6 ms vs. controls 67.1 ± 25.4 ms;  P  < 0.0001) with parasympathetic loss (RMSSD; 53.0 ± 36.6 ms vs. controls 67.9 ± 35.2 ms;  P  < 0.0001) with sympathetic overdrive (LF:HF ratio; 1.4 ± 1.7 vs. controls 1.0 ± 1.1;  P  < 0.0001).,"[{'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH.""}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'El Ghormli', 'Affiliation': 'George Washington University Biostatistics Center, Rockville, MD elghorml@bsc.gwu.edu.'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Vajravelu', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Fida', 'Initials': 'F', 'LastName': 'Bacha', 'Affiliation': ""Texas Children's Hospital, Baylor College of Medicine, Houston, TX.""}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Farrell', 'Affiliation': 'Case Western Reserve University, Cleveland, OH.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Gidding', 'Affiliation': 'FH Foundation, Pasadena, CA.'}, {'ForeName': 'Lorraine E', 'Initials': 'LE', 'LastName': 'Levitt Katz', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Jeanie B', 'Initials': 'JB', 'LastName': 'Tryggestad', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Neil H', 'Initials': 'NH', 'LastName': 'White', 'Affiliation': 'Washington University in St. Louis, St. Louis, MO.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Urbina', 'Affiliation': ""Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH.""}]",Diabetes care,['10.2337/dc19-0993']
867,29369834,Oral Hypertonic Saline Is Effective in Reversing Acute Mild-to-Moderate Symptomatic Exercise -Associated Hyponatremia.,"OBJECTIVES


To determine whether oral administration of 3% hypertonic saline (HTS) is as efficacious as intravenous (IV) 3% saline in reversing symptoms of mild-to-moderate symptomatic exercise-associated hyponatremia (EAH) in athletes during and after a long-distance triathlon.
DESIGN


Noninferiority, open-label, parallel-group, randomized control trial to IV or oral HTS. We used permuted block randomization with sealed envelopes, containing the word either ""oral"" or ""IV.""
SETTING


Annual long-distance triathlon (3.8-km swim, 180-km bike, and 42-km run) at Mont-Tremblant, Quebec, Canada.
PARTICIPANTS


Twenty race finishers with mild to moderately symptomatic EAH.
INDEPENDENT VARIABLES


Age, sex, race finish time, and 9 clinical symptoms.
MAIN OUTCOME MEASURES


Time from treatment to discharge.
METHODS


We successfully randomized 20 participants to receive either an oral (n = 11) or IV (n = 9) bolus of HTS. We performed venipuncture to measure serum sodium (Na) at presentation to the medical clinic and at time of symptom resolution after the intervention.
RESULTS


The average time from treatment to discharge was 75.8 minutes (SD 29.7) for the IV treatment group and 50.3 minutes (SD 26.8) for the oral treatment group (t test, P = 0.02). Serum Na before and after treatment was not significantly different in both groups. There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
CONCLUSIONS


Oral HTS is effective in reversing symptoms of mild-to-moderate hyponatremia in EAH.",2018,"There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
","['Twenty race finishers with mild to moderately symptomatic EAH', 'Annual long-distance triathlon (3.8-km swim, 180-km bike, and 42-km run) at Mont-Tremblant, Quebec, Canada']","['Oral Hypertonic Saline', 'oral HTS', 'HTS', 'sealed envelopes, containing the word either ""oral"" or ""IV', '3% hypertonic saline (HTS']",['average time'],"[{'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}]",20.0,0.145485,"There was no difference on presentation between groups in age, sex, or race finish time, both groups presented with an average of 6 symptoms.
","[{'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Bridges', 'Affiliation': 'Department of Emergency Medicine, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Tawfeeq', 'Initials': 'T', 'LastName': 'Altherwi', 'Affiliation': 'EM FRCP Program-McGill University, Montreal, QC, Canada.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Correa', 'Affiliation': 'Department of Mathematics and Statistics, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Hew-Butler', 'Affiliation': 'Oakland University, Rochester, Michigan.'}]",Clinical journal of sport medicine : official journal of the Canadian Academy of Sport Medicine,['10.1097/JSM.0000000000000573']
868,31574323,Multisensory stimuli enhance 3-year-old children's executive function: A three-dimensional object version of the standard Dimensional Change Card Sort.,"A three-dimensional object version of the standard Dimensional Change Card Sort (DCCS) was developed to examine the influence of multisensory stimuli on 3-year-old children's executive function. Whereas the developmental phenomenon marking 3-year-olds' difficulties with rule use in the standard DCCS can be attributed to several cognitive factors, we examined the possibility that better encoding of object features could facilitate children's rule-switching behavior. We examined whether 3-year-olds might be able to capitalize on cues available to multiple senses to create a more robust representation of object features that would enable them to overcome previous difficulties with rule switching in the standard DCCS. Participants were randomly assigned to the standard two-dimensional DCCS or the three-dimensional object version that was designed to match the rabbit and boat images used in the card version. The 3-year-olds who completed the object version outperformed those who completed the standard card version, succeeding in switching rules more accurately when provided with visual, auditory-verbal labeling, and tactile information of object features. Notably, more children achieved perfect accuracy and fewer children achieved floor-level performance in the object version than in the card version. We attribute 3-year-olds' success in the object version to greater cognitive control made possible by the enhanced encoding of the stimulus properties through multisensory input and enhanced cognitive processing of ecologically valid three-dimensional objects.",2020,"The 3-year-olds who completed the object version outperformed those who completed the standard card version, succeeding in switching rules more accurately when provided with visual, auditory-verbal labeling, and tactile information of object features.",[],"['standard two-dimensional DCCS or the three-dimensional object version that was designed to match the rabbit and boat images used in the card version', 'standard Dimensional Change Card Sort (DCCS']","['floor-level performance', ""Multisensory stimuli enhance 3-year-old children's executive function""]",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C3887509', 'cui_str': 'Rabbits'}, {'cui': 'C0085910', 'cui_str': 'Boats'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]","[{'cui': 'C0016249', 'cui_str': 'Floors'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",,0.0259163,"The 3-year-olds who completed the object version outperformed those who completed the standard card version, succeeding in switching rules more accurately when provided with visual, auditory-verbal labeling, and tactile information of object features.","[{'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Beaucage', 'Affiliation': 'Department of Psychology, MacEwan University, Edmonton, Alberta T5J 4S2, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Skolney', 'Affiliation': 'Department of Psychology, MacEwan University, Edmonton, Alberta T5J 4S2, Canada.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hewes', 'Affiliation': 'Department of Human Services and Early Learning, MacEwan University, Edmonton, Alberta T5J 4S2, Canada; Faculty of Education and Social Work, Thompson Rivers University, Kamloops BC V2E0C8, Canada.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Vongpaisal', 'Affiliation': 'Department of Psychology, MacEwan University, Edmonton, Alberta T5J 4S2, Canada. Electronic address: vongpaisalt@macewan.ca.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.104694']
869,31576565,Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression.,"OBJECTIVES


A recent trial comparing Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and supportive psychotherapy in chronic depression found CBASP to be more effective in treating depressive symptoms. We aimed to evaluate adverse events that occurred during this trial.
MATERIALS AND METHOD


A randomized trial of chronically depressed outpatients was performed. The treatment included 32 sessions of CBASP or supportive psychotherapy. Therapists asked patients about adverse events and their intensity in each session using a standardized checklist. We analyzed the mean number of (severe) adverse events per patient up to Session 32 with gamma frailty recurrent event models.
RESULTS


Two hundred and sixty patients were included in the analyses (66% female, mean age 45 years). Patients in the supportive psychotherapy group reported less severe adverse events in general, and less severe adverse events related to personal life and to occupational life than patients in the CBASP group. Less adverse events related to suicidal thoughts were reported in the CBASP compared with the supportive psychotherapy group.
CONCLUSIONS


Differences in the adverse events profile may be explained by the treatment elements. Adverse events related to personal and occupational life for example might be considered a necessary and expected yet temporary adverse treatment outcome of an effective CBASP treatment.",2020,"Patients in the supportive psychotherapy group reported less severe adverse events in general, and less severe adverse events related to personal life and to occupational life than patients in the CBASP group.","['Two hundred and sixty patients were included in the analyses (66% female, mean age 45 years', 'chronically depressed outpatients', 'patients with chronic depression']","['nonspecific psychotherapy', 'CBASP or supportive psychotherapy', 'supportive psychotherapy', 'Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and supportive psychotherapy', 'CBASP']","['severe adverse events', 'adverse events', 'mean number of (severe) adverse events', 'Adverse events', 'personal life and to occupational life']","[{'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression (disorder)'}]","[{'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0221295', 'cui_str': 'Supportive psychotherapy'}, {'cui': 'C1160858', 'cui_str': 'Behavior care assessment'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}]",260.0,0.0279796,"Patients in the supportive psychotherapy group reported less severe adverse events in general, and less severe adverse events related to personal life and to occupational life than patients in the CBASP group.","[{'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Meister', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Lanio', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fangmeier', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, Freiburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schramm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Freiburg, Freiburg, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Zobel', 'Affiliation': 'Psychology School at the Fresenius University of Applied Sciences Berlin, Berlin, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, Eberhard Karls University, Tübingen, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Nestoriuc', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",Journal of clinical psychology,['10.1002/jclp.22869']
870,31860387,Effects of Pyrroloquinoline Quinone (PQQ) Supplementation on Aerobic Exercise Performance and Indices of Mitochondrial Biogenesis in Untrained Men.,"Objective:  Pyrroloquinoline quinone (PQQ) is a novel supplement involved in processes such as mitochondrial biogenesis and cellular energy metabolism. Since endurance exercise and PQQ exhibit similar mechanisms for mitochondrial biogenesis, it is plausible that PQQ may have ergogenic value. Therefore, the purpose of this study was to examine the effects of a six-week endurance exercise training program on mitochondrial biogenesis and aerobic performance in non-endurance-trained males. Methods:  Twenty-three males were randomized to consume 20 mg/day of PQQ or placebo (PLC). Both groups followed a supervised six-week endurance exercise training program. Body composition was assessed by dual-energy-x-ray-absorptiometry (DEXA). Aerobic exercise performance and peroxisome proliferator-activated receptor γ coactivator-1α (PGC-1α), a biochemical marker for mitochondrial biogenesis, were assessed before and after the six-week endurance training/supplementation program. Results:  There were no significant differences between groups in aerobic performance after endurance-training (p > 0.05). However, there were significant improvements in peak oxygen consumption (VO 2 peak) and total exercise test duration after endurance-training, irrespective of group (p < 0.05). The PQQ group had a significant increase in PGC-1α protein levels from baseline to post endurance training compared to PLC (p < 0.05). Furthermore, the PQQ group had higher PGC-1α protein levels after 6 weeks of endurance training compared to PLC (p < 0.05). Conclusions:  Supplementation of PQQ does not appear to elicit any ergogenic effects regarding aerobic performance or body composition but appears to impact mitochondrial biogenesis by way of significant elevations in PGC-1α protein content.",2020,The PQQ group had a significant increase in PGC-1α protein levels from baseline to post endurance training compared to PLC (p < 0.05).,"['Methods:  Twenty-three males', 'Untrained Men', 'non-endurance-trained males']","['six-week endurance exercise training program', 'Pyrroloquinoline Quinone (PQQ) Supplementation', 'supervised six-week endurance exercise training program', 'PQQ or placebo (PLC', 'Pyrroloquinoline quinone (PQQ']","['peak oxygen consumption (VO 2 peak) and total exercise test duration', 'Body composition', 'Aerobic Exercise Performance and Indices of Mitochondrial Biogenesis', 'aerobic performance', 'PGC-1α protein levels', 'mitochondrial biogenesis and aerobic performance']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0066153', 'cui_str': 'PQQ Cofactor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3494456', 'cui_str': 'Mitochondrial Biogenesis'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}]",23.0,0.034533,The PQQ group had a significant increase in PGC-1α protein levels from baseline to post endurance training compared to PLC (p < 0.05).,"[{'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Hwang', 'Affiliation': 'Department of Health, Human Performance, and Recreation, Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas, USA.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Machek', 'Affiliation': 'Department of Health, Human Performance, and Recreation, Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas, USA.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Cardaci', 'Affiliation': 'Department of Health, Human Performance, and Recreation, Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas, USA.'}, {'ForeName': 'Dylan T', 'Initials': 'DT', 'LastName': 'Wilburn', 'Affiliation': 'Department of Health, Human Performance, and Recreation, Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas, USA.'}, {'ForeName': 'Caelin S', 'Initials': 'CS', 'LastName': 'Kim', 'Affiliation': 'Department of Health, Human Performance, and Recreation, Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas, USA.'}, {'ForeName': 'Emiliya S', 'Initials': 'ES', 'LastName': 'Suezaki', 'Affiliation': 'Department of Health, Human Performance, and Recreation, Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas, USA.'}, {'ForeName': 'Darryn S', 'Initials': 'DS', 'LastName': 'Willoughby', 'Affiliation': 'Department of Health, Human Performance, and Recreation, Exercise and Biochemical Nutrition Laboratory, Baylor University, Waco, Texas, USA.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2019.1705203']
871,29294791,Mentoring Pediatric Victims of Interpersonal Violence Reduces Recidivism.,"Pediatric interpersonal violence is a public health crisis resulting in morbidity and mortality and recidivism. St. Louis City and surrounding areas have the highest rates of youth interpersonal violence nationally. St. Louis Children's Hospital (SLCH) Social Work in conjunction with Pediatric Emergency Medicine established a novel emergency department (ED)-initiated program to determine whether co-location of services followed by outpatient mentoring reduced the rate of morbidity, mortality, and recidivism in youths experiencing interpersonal violence. SLCH developed the ""Empowering Youth Through Interpersonal Violence Prevention Program,"" co-locating initial social work services and emergency medical services in the pediatric ED. Youths, ages 8 to 17 years, presenting for interpersonal violence were approached for immediate social work counseling and subsequent individualized outpatient mentoring, developed from national best practices and model programs. A prospective 2:1 randomized, controlled pilot study assessing for youth morbidity, mortality, and recidivism was conducted for program service feasibility from 2012 to 2014. The study was followed by a 1-year retrospective analysis of program service integration as a hospital standard-of-care evaluating the same outcome measures. Of the 24 youths who participated in the pilot study and received the intervention, there was a 4% rate of morbidity and recidivism. Conversely, there was a 3.4% rate of mortality, 6.7% rate of morbidity, and 11.8% recidivism rate in those who refused to participate in services. EYIPP was offered as a service from 2014 to 2015 and 57 youths participated with a 3.5% rate of both morbidity and recidivism. During this time, 78 eligible youths declined services with a 1.1% rate of morbidity, and 2.3% recidivism rate. This novelprogram reduces recidivism, morbidity, and mortality in youths presenting to SLCH for interpersonal violence-related injuries suggesting that co-location of social services in the ED, followed by individualized mentoring may be important for engagement.",2020,"This novelprogram reduces recidivism, morbidity, and mortality in youths presenting to SLCH for interpersonal violence-related injuries suggesting that co-location of social services in the ED, followed by individualized mentoring may be important for engagement.","['Mentoring Pediatric Victims of Interpersonal Violence Reduces Recidivism', ""St. Louis Children's Hospital (SLCH"", 'Youths, ages 8 to 17 years, presenting for interpersonal violence were approached for immediate social work counseling and subsequent individualized outpatient mentoring, developed from national best practices and model programs', '78 eligible youths declined services with a 1.1% rate of morbidity, and 2.3% recidivism rate', 'youths presenting to SLCH for interpersonal violence-related injuries', 'youths experiencing interpersonal violence', '24 youths who participated in the pilot study', 'youth morbidity, mortality, and recidivism was conducted for program service feasibility from 2012 to 2014']","['EYIPP', 'SLCH']","['recidivism, morbidity, and mortality', 'morbidity', 'rate of morbidity, mortality, and recidivism', 'rate of mortality']","[{'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C4255266', 'cui_str': 'Mentoring'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",[],"[{'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0216662,"This novelprogram reduces recidivism, morbidity, and mortality in youths presenting to SLCH for interpersonal violence-related injuries suggesting that co-location of social services in the ED, followed by individualized mentoring may be important for engagement.","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lumba-Brown', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Margie', 'Initials': 'M', 'LastName': 'Batek', 'Affiliation': 'Washington University School of Medicine in St. Louis, MO, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Choi', 'Affiliation': 'Washington University School of Medicine in St. Louis, MO, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Keller', 'Affiliation': 'Washington University School of Medicine in St. Louis, MO, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kennedy', 'Affiliation': 'Washington University School of Medicine in St. Louis, MO, USA.'}]",Journal of interpersonal violence,['10.1177/0886260517705662']
872,29294858,"TakeCARE, a Video to Promote Bystander Behavior on College Campuses: Replication and Extension.","Previous research has demonstrated that college students who view TakeCARE, a video bystander program designed to encourage students to take action to prevent sexual and relationship violence (i.e., bystander behavior), display more bystander behavior relative to students who view a control video. The current study aimed to replicate and extend these findings by testing two different methods of administering TakeCARE and examining moderators of TakeCARE's effects on bystander behavior. Students at four universities ( n  = 557) were randomly assigned to one of three conditions: (a) view TakeCARE in a monitored computer lab, (b) view TakeCARE at their own convenience after receiving an email link to the video, or (c) view a video about study skills (control group). Participants completed measures of bystander behavior at baseline and at a 1-month follow-up. Participants in both TakeCARE conditions reported more bystander behavior at follow-up assessments, compared with participants in the control condition. The beneficial effect of TakeCARE did not differ significantly across administration methods. However, the effects of TakeCARE on bystander behavior were moderated by students' perceptions of campus responsiveness to sexual violence, with more potent effects when students perceived their institution as responsive to reports of sexual violence.",2020,"Participants in both TakeCARE conditions reported more bystander behavior at follow-up assessments, compared with participants in the control condition.","['college students', 'Students at four universities ( n = 557']","['view TakeCARE in a monitored computer lab, (b) view TakeCARE at their own convenience after receiving an email link to the video, or (c) view a video about study skills (control group', 'TakeCARE']",['bystander behavior'],"[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0871455', 'cui_str': 'Study Skills'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}]",557.0,0.0250129,"Participants in both TakeCARE conditions reported more bystander behavior at follow-up assessments, compared with participants in the control condition.","[{'ForeName': 'Ernest N', 'Initials': 'EN', 'LastName': 'Jouriles', 'Affiliation': 'Southern Methodist University, Dallas, TX, USA.'}, {'ForeName': 'Kelli S', 'Initials': 'KS', 'LastName': 'Sargent', 'Affiliation': 'Southern Methodist University, Dallas, TX, USA.'}, {'ForeName': 'Katie Lee', 'Initials': 'KL', 'LastName': 'Salis', 'Affiliation': 'Stony Brook University, NY, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Caiozzo', 'Affiliation': 'Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenfield', 'Affiliation': 'Southern Methodist University, Dallas, TX, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cascardi', 'Affiliation': 'William Paterson University, Wayne, NJ, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Grych', 'Affiliation': 'Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'K Daniel', 'Initials': 'KD', 'LastName': ""O'Leary"", 'Affiliation': 'Stony Brook University, NY, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'McDonald', 'Affiliation': 'Southern Methodist University, Dallas, TX, USA.'}]",Journal of interpersonal violence,['10.1177/0886260517718189']
873,30786186,Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer.,"BACKGROUND


Ambulatory patients receiving systemic cancer therapy are at varying risk for venous thromboembolism. However, the benefit of thromboprophylaxis in these patients is uncertain.
METHODS


In this double-blind, randomized trial involving high-risk ambulatory patients with cancer (Khorana score of ≥2, on a scale from 0 to 6, with higher scores indicating a higher risk of venous thromboembolism), we randomly assigned patients without deep-vein thrombosis at screening to receive rivaroxaban (at a dose of 10 mg) or placebo daily for up to 180 days, with screening every 8 weeks. The primary efficacy end point was a composite of objectively confirmed proximal deep-vein thrombosis in a lower limb, pulmonary embolism, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, and death from venous thromboembolism and was assessed up to day 180. In a prespecified supportive analysis involving the same population, the same end point was assessed during the intervention period (first receipt of trial agent to last dose plus 2 days). The primary safety end point was major bleeding.
RESULTS


Of 1080 enrolled patients, 49 (4.5%) had thrombosis at screening and did not undergo randomization. Of the 841 patients who underwent randomization, the primary end point occurred in 25 of 420 patients (6.0%) in the rivaroxaban group and in 37 of 421 (8.8%) in the placebo group (hazard ratio, 0.66; 95% confidence interval [CI], 0.40 to 1.09; P = 0.10) in the period up to day 180. In the prespecified intervention-period analysis, the primary end point occurred in 11 patients (2.6%) in the rivaroxaban group and in 27 (6.4%) in the placebo group (hazard ratio, 0.40; 95% CI, 0.20 to 0.80). Major bleeding occurred in 8 of 405 patients (2.0%) in the rivaroxaban group and in 4 of 404 (1.0%) in the placebo group (hazard ratio, 1.96; 95% CI, 0.59 to 6.49).
CONCLUSIONS


In high-risk ambulatory patients with cancer, treatment with rivaroxaban did not result in a significantly lower incidence of venous thromboembolism or death due to venous thromboembolism in the 180-day trial period. During the intervention period, rivaroxaban led to a substantially lower incidence of such events, with a low incidence of major bleeding. (Funded by Janssen and others; CASSINI ClinicalTrials.gov number, NCT02555878.).",2019,"The primary efficacy end point was a composite of objectively confirmed proximal deep-vein thrombosis in a lower limb, pulmonary embolism, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, and death from venous thromboembolism and was assessed up to day 180.","['high-risk ambulatory patients with cancer (Khorana score of ≥2, on a scale from 0 to 6, with higher scores indicating a higher risk of venous thromboembolism', 'High-Risk Ambulatory Patients with Cancer', '1080 enrolled patients, 49 (4.5%) had thrombosis at screening and did not undergo randomization', 'high-risk ambulatory patients with cancer', 'Ambulatory patients receiving']","['rivaroxaban', 'systemic cancer therapy', 'placebo', 'Rivaroxaban']","['Major bleeding', 'major bleeding', 'composite of objectively confirmed proximal deep-vein thrombosis in a lower limb, pulmonary embolism, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, and death from venous thromboembolism', 'venous thromboembolism or death']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}]",1080.0,0.530441,"The primary efficacy end point was a composite of objectively confirmed proximal deep-vein thrombosis in a lower limb, pulmonary embolism, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, and death from venous thromboembolism and was assessed up to day 180.","[{'ForeName': 'Alok A', 'Initials': 'AA', 'LastName': 'Khorana', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Gerald A', 'Initials': 'GA', 'LastName': 'Soff', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Kakkar', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Saroj', 'Initials': 'S', 'LastName': 'Vadhan-Raj', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Riess', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Wun', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Streiff', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Garcia', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Howard A', 'Initials': 'HA', 'LastName': 'Liebman', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Chandra P', 'Initials': 'CP', 'LastName': 'Belani', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Eileen M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Jai N', 'Initials': 'JN', 'LastName': 'Patel', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Habte A', 'Initials': 'HA', 'LastName': 'Yimer', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wildgoose', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Burton', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Ujjwala', 'Initials': 'U', 'LastName': 'Vijapurkar', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Simrati', 'Initials': 'S', 'LastName': 'Kaul', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Eikelboom', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McBane', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Bauer', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Kuderer', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': 'Gary H', 'Initials': 'GH', 'LastName': 'Lyman', 'Affiliation': 'From the Department of Hematology and Medical Oncology, Taussig Cancer Institute and Case Comprehensive Cancer Center, Cleveland Clinic, Cleveland (A.A.K.); the Department of Medicine, Memorial Sloan Kettering Cancer Center (G.A.S., E.M.O.), and Weill Cornell Medical College (G.A.S., E.M.O.), New York; the Thrombosis Research Institute and University College London, London (A.K.K.); University of Texas M.D. Anderson Cancer Center, Houston (S.V.-R.), and U.S. Oncology Research-Texas Oncology, Tyler (H.A.Y.) - both in Texas; the Department of Medicine, Charité Universitätsmedizin Berlin, Berlin (H.R.); the Division of Hematology-Oncology, University of California Davis School of Medicine, Sacramento (T.W.), and the Keck School of Medicine, University of Southern California, Los Angeles (H.A.L.); the Division of Hematology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore (M.B.S.); the University of Washington School of Medicine (D.A.G., N.M.K., G.H.L.), Advanced Cancer Research Group (N.M.K.), and Fred Hutchinson Cancer Research Center (G.H.L.), Seattle; Penn State Cancer Institute, Milton S. Hershey Medical Center, Hershey, PA (C.P.B.); the Department of Cancer Pharmacology, Levine Cancer Institute, Atrium Health, Charlotte, NC (J.N.P.); Janssen Scientific Affairs, Titusville (P.W., P.B., S.K.), and Janssen Research and Development, Raritan (U.V.) - both in New Jersey; the Department of Medicine, McMaster University, Hamilton, ON, Canada (J.E.); the Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN (R.M.); and the Division of Hematology-Oncology, Beth Israel Deaconess Medical Center, Boston (K.A.B.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1814630']
874,31628783,"Pharmacokinetic Similarity of ABP 710, a Proposed Biosimilar to Infliximab: Results From a Randomized, Single-Blind, Single-Dose, Parallel-Group Study in Healthy Subjects.","This was a randomized, single-blind, single-dose, 3-arm parallel-group study. Healthy subjects were randomized to receive ABP 710 (n = 50) or infliximab reference product (RP) sourced from the United States (infliximab US; n = 50) or the European Union (infliximab EU; n = 50) 5 mg/kg intravenously over 2 hours. The primary endpoint was area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC inf  ) for the comparison of ABP 710 to infliximab US and infliximab EU. Secondary endpoints included safety, tolerability, and immunogenicity. AUC inf  was similar across the 3 groups, showing similarity of ABP 710 to infliximab RP as well as similarity of infliximab US with infliximab EU. Geometric mean ratio of AUC inf  was 0.89 between ABP 710 and infliximab US, 1.00 between ABP 710 and infliximab EU, and 1.11 between infliximab US and infliximab EU. All 90% confidence intervals of the geometric mean ratios were fully contained within the prespecified standard pharmacokinetic equivalence criteria range of 0.80 to 1.25. Treatment-related adverse events were mild to moderate and reported for 83.7%, 86.0%, and 83.7% of subjects in the ABP 710, infliximab US, and infliximab EU treatment groups, respectively; incidence of antidrug antibody rates observed across the 3 groups were similar. Results of this study demonstrated pharmacokinetic similarity of ABP 710 with infliximab RP following a single 5-mg/kg intravenous injection. The safety and tolerability of ABP 710 and infliximab RP were comparable. These results add to the totality of evidence providing further support that the proposed biosimilar ABP 710 is similar to infliximab RP. (Trial ID: ACTRN12614000903684.).",2020,"Geometric mean ratio of AUC inf  was 0.89 between ABP 710 and infliximab US, 1.00 between ABP 710 and infliximab EU, and 1.11 between infliximab US and infliximab EU.","['Healthy Subjects', 'Healthy subjects']","['ABP', 'infliximab reference product (RP) sourced from the United States (infliximab US; n\xa0=\xa050) or the European Union (infliximab EU; n\xa0=\xa050) 5 mg/kg intravenously over 2 hours', 'Infliximab']","['adverse events', 'antidrug antibody rates', 'AUC inf', 'area under the serum concentration-time curve from time 0 extrapolated to infinity (AUC inf  ', 'Geometric mean ratio of AUC inf', 'safety and tolerability of ABP 710 and infliximab RP', 'safety, tolerability, and immunogenicity', 'geometric mean ratios']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205136', 'cui_str': 'Over (qualifier value)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}]",710.0,0.0476926,"Geometric mean ratio of AUC inf  was 0.89 between ABP 710 and infliximab US, 1.00 between ABP 710 and infliximab EU, and 1.11 between infliximab US and infliximab EU.","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Chow', 'Affiliation': 'Clinical Pharmacology, Amgen Inc., Thousand Oaks, California, USA.'}, {'ForeName': 'MyungShin', 'Initials': 'M', 'LastName': 'Oh', 'Affiliation': 'Biostatistics, Amgen Inc., Thousand Oaks, California, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Gessner', 'Affiliation': 'Clinical Immunology, Amgen Inc., Thousand Oaks, California, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Fanjiang', 'Affiliation': 'Biosimilars, Amgen Inc., Thousand Oaks, California, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.738']
875,31615197,Stepping training with external feedback relating to lower limb support ability effectively improved complex motor activity in ambulatory patients with stroke: a randomized controlled trial.,"BACKGROUND


Lower limb support ability is important for steady and efficient mobility, but previous data commonly involved training during double stance positions, with or without external feedback, using a complex and costly machine.
AIM


To compare the effects of stepping training with or without external feedback in relation to the lower limb support ability of the affected limb on the functional ability necessary for independence in individuals with stroke.
DESIGN


A single-blinded, randomized controlled trial.
SETTING


Tertiary rehabilitation centers.
POPULATION


Ambulatory participants with stroke who walked independently over at least 10 meters with or without walking devices.
METHODS


Thirty-six participants were randomly arranged to be involved in a program of stepping training with or without external feedback related to the lower limb support ability of the affected limb (18 participants/group) for 30 minutes, followed by overground walking training for 10 minutes, 5 days/week over 4 weeks. The outcomes, including the lower limb support ability of the affected legs during stepping, functional ability and spatial walking data, were assessed prior to training, immediately after the first training session, and after 2- and 4-week training.
RESULTS


Participants demonstrated significant improvement in the amount of lower limb support ability, immediately after the first training with external feedback. Then, these participants showed further improvement in both the amount and duration of lower limb support ability, as well as the Timed Up and Go data after 2 and 4 weeks of training (P<0.05). This improvement was not found following control training.
CONCLUSIONS


The external feedback relating to lower limb support ability during stepping training effectively improved the movement stability and complex motor activity of ambulatory individuals with stroke who had long post-stroke time (approximately 3 years).
CLINICAL REHABILITATION IMPACT


Stepping training protocols and feedback can be easily applied in various settings using the amount of body weight from an upright digital bathroom scale. Thus, the findings offer an alternative rehabilitation strategy for clinical, community and home-based settings for stroke individuals.",2020,"The external feedback relating to lower limb support ability during stepping training effectively improved the movement stability and complex motor activity of ambulatory individuals with stroke who had long post-stroke time (approximately 3 years).
","['Ambulatory participants with stroke who walked independently over at least 10 meters with or without walking devices', 'Thirty-six participants', 'ambulatory individuals with stroke who had long post-stroke time (approximately 3 years', 'Tertiary rehabilitation centres', 'ambulatory patients with stroke', 'individuals with stroke']","['stepping training with or without external feedback', 'Stepping training with external feedback relating to lower limb support ability', 'stepping training with or without external feedback related to the lower limb support ability of the affected limb (18 participants/group) for 30 minutes, followed by overground walking training']","['movement stability and complex motor activity', 'lower limb support ability of the affected legs during stepping, functional ability and spatial walking data', 'amount and duration of lower limb support ability', 'amount of lower limb support ability', 'complex motor activity']","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",36.0,0.0308169,"The external feedback relating to lower limb support ability during stepping training effectively improved the movement stability and complex motor activity of ambulatory individuals with stroke who had long post-stroke time (approximately 3 years).
","[{'ForeName': 'Sirisuda', 'Initials': 'S', 'LastName': 'Phonthee', 'Affiliation': 'Improvement to Physical Performance and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Pipatana', 'Initials': 'P', 'LastName': 'Amatachaya', 'Affiliation': 'Improvement to Physical Performance and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Thanat', 'Initials': 'T', 'LastName': 'Sooknuan', 'Affiliation': 'Improvement to Physical Performance and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Sugalya', 'Initials': 'S', 'LastName': 'Amatachaya', 'Affiliation': 'Improvement to Physical Performance and Quality of Life (IPQ) Research Group, Khon Kaen University, Khon Kaen, Thailand - samata@kku.ac.th.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.19.05907-0']
876,31633158,Lopinavir-Ritonavir Impairs Adrenal Function in Infants.,"BACKGROUND


Perinatal treatment with lopinavir boosted by ritonavir (LPV/r) is associated with steroidogenic abnormalities. Long-term effects in infants have not been studied.
METHODS


Adrenal-hormone profiles were compared at weeks 6 and 26 between human immunodeficiency virus (HIV)-1-exposed but uninfected infants randomly assigned at 7 days of life to prophylaxis with LPV/r or lamivudine (3TC) to prevent transmission during breastfeeding. LPV/r in vitro effect on steroidogenesis was assessed in H295R cells.
RESULTS


At week 6, 159 frozen plasma samples from Burkina Faso and South Africa were assessed (LPV/r group: n = 92; 3TC group: n = 67) and at week 26, 95 samples from Burkina Faso (LPV/r group: n = 47; 3TC group: n = 48). At week 6, LPV/r-treated infants had a higher median dehydroepiandrosterone (DHEA) level than infants from the 3TC arm: 3.91 versus 1.48 ng/mL (P < .001). Higher DHEA levels (>5 ng/mL) at week 6 were associated with higher 17-OH-pregnenolone (7.78 vs 3.71 ng/mL, P = .0004) and lower testosterone (0.05 vs 1.34 ng/mL, P = .009) levels in LPV/r-exposed children. There was a significant correlation between the DHEA and LPV/r AUC levels (ρ = 0.40, P = .019) and Ctrough (ρ = 0.40, P = .017). At week 26, DHEA levels remained higher in the LPV/r arm: 0.45 versus 0.13 ng/mL (P = .002). Lopinavir, but not ritonavir, inhibited CYP17A1 and CYP21A2 activity in H295R cells.
CONCLUSIONS


Lopinavir was associated with dose-dependent adrenal dysfunction in infants. The impact of long-term exposure and potential clinical consequences require evaluation.
CLINICAL TRIALS REGISTRATION


NCT00640263.",2020,"Higher DHEA levels (>5 ng/mL) at week 6 were associated with higher 17-OH-pregnenolone (7.78 vs 3.71 ng/mL, P = .0004) and lower testosterone (0.05 vs 1.34 ng/mL, P = .009) levels in LPV/r-exposed children.","['Infants', 'Adrenal-hormone profiles were compared at weeks 6 and 26 between human immunodeficiency virus (HIV)-1-exposed but uninfected infants', 'infants']","['LPV/r or lamivudine (3TC', 'Lopinavir', 'lopinavir boosted by ritonavir (LPV/r', 'Lopinavir-Ritonavir']","['17-OH-pregnenolone', 'median dehydroepiandrosterone (DHEA) level', 'Higher DHEA levels', 'DHEA and LPV/r AUC levels', 'lower testosterone', 'DHEA levels']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1445654', 'cui_str': 'Adrenal hormone agent'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}]","[{'cui': 'C0373704', 'cui_str': 'Pregnenolone'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}]",159.0,0.305568,"Higher DHEA levels (>5 ng/mL) at week 6 were associated with higher 17-OH-pregnenolone (7.78 vs 3.71 ng/mL, P = .0004) and lower testosterone (0.05 vs 1.34 ng/mL, P = .009) levels in LPV/r-exposed children.","[{'ForeName': 'Dulanjalee', 'Initials': 'D', 'LastName': 'Kariyawasam', 'Affiliation': 'Pediatric Endocrinology, Gynecology, and Diabetology Unit, Hopital Universitaire Necker-Enfants Malades, Assistance Publique-Hopitaux de Paris (AP-HP), Paris, France.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Peries', 'Affiliation': 'Pathogenesis and Control of Chronic Infections, INSERM U1058, Universite de Montpellier, Etablissement Francais du Sang, Montpellier, France.'}, {'ForeName': 'Frantz', 'Initials': 'F', 'LastName': 'Foissac', 'Affiliation': 'Service de Pharmacologie Clinique, Hopital Cochin, AP-HP, Groupe Hospitalier Paris Centre, France.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Eymard-Duvernay', 'Affiliation': 'Pathogenesis and Control of Chronic Infections, INSERM U1058, Universite de Montpellier, Etablissement Francais du Sang, Montpellier, France.'}, {'ForeName': 'Thorkild', 'Initials': 'T', 'LastName': 'Tylleskär', 'Affiliation': 'Centre for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Mandisa', 'Initials': 'M', 'LastName': 'Singata-Madliki', 'Affiliation': 'Effective Care Research Unit, University of Fort Hare, Cecilia Makiwane Hospital, East London, South Africa.'}, {'ForeName': 'Chipepo', 'Initials': 'C', 'LastName': 'Kankasa', 'Affiliation': 'University of Zambia, School of Medicine, Department of Pediatrics and Child Health, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meda', 'Affiliation': 'Center of International Research for Health, Faculty of Health Sciences, University of Ouagadougou, Ouagadougou, Burkina Faso.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tumwine', 'Affiliation': 'Department of Pediatrics and Child Health, School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Mwiya', 'Initials': 'M', 'LastName': 'Mwiya', 'Affiliation': 'University of Zambia, School of Medicine, Department of Pediatrics and Child Health, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Ingunn', 'Initials': 'I', 'LastName': 'Engebretsen', 'Affiliation': 'Centre for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Christa E', 'Initials': 'CE', 'LastName': 'Flück', 'Affiliation': 'Pediatric Endocrinology, Diabetology, and Metabolism, Department of Pediatrics and Department of BioMedical Research, University Hospital Inselspital Bern, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Michaela F', 'Initials': 'MF', 'LastName': 'Hartmann', 'Affiliation': 'Steroid Research and Mass Spectrometry Unit, Division of Pediatric Endocrinology and Diabetology, Center of Child and Adolescent Medicine, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Stefan A', 'Initials': 'SA', 'LastName': 'Wudy', 'Affiliation': 'Steroid Research and Mass Spectrometry Unit, Division of Pediatric Endocrinology and Diabetology, Center of Child and Adolescent Medicine, Justus-Liebig-University, Giessen, Germany.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Hirt', 'Affiliation': 'Service de Pharmacologie Clinique, Hopital Cochin, AP-HP, Groupe Hospitalier Paris Centre, France.'}, {'ForeName': 'Jean Marc', 'Initials': 'JM', 'LastName': 'Treluyer', 'Affiliation': 'Service de Pharmacologie Clinique, Hopital Cochin, AP-HP, Groupe Hospitalier Paris Centre, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Molès', 'Affiliation': 'Pathogenesis and Control of Chronic Infections, INSERM U1058, Universite de Montpellier, Etablissement Francais du Sang, Montpellier, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Blanche', 'Affiliation': 'Pediatric Immunology-Hematology and Rheumatology Unit, Hopital Universitaire Necker-Enfants Malades, AP-HP, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Van De Perre', 'Affiliation': 'Service de Pharmacologie Clinique, Hopital Cochin, AP-HP, Groupe Hospitalier Paris Centre, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Polak', 'Affiliation': 'Pediatric Endocrinology, Gynecology, and Diabetology Unit, Hopital Universitaire Necker-Enfants Malades, Assistance Publique-Hopitaux de Paris (AP-HP), Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Nagot', 'Affiliation': 'Pathogenesis and Control of Chronic Infections, INSERM U1058, Universite de Montpellier, Etablissement Francais du Sang, Montpellier, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz888']
877,31617568,Immunogenicity of 2 and 3 Doses of the Quadrivalent Human Papillomavirus Vaccine up to 120 Months Postvaccination: Follow-up of a Randomized Clinical Trial.,"BACKGROUND


Several countries have implemented a 2-dose (2D) human papillomavirus (HPV) vaccination schedule for adolescents based on immunobridging studies. We compared immunogenicity of 2D vs 3-dose (3D) schedules of the quadrivalent vaccine (4vHPV) up to 10 years after the first dose.
METHODS


Girls aged 9-13 years were randomized to receive 2D or 3D and were compared with women aged 16-26 receiving 3D at day 1 and months 7, 24, and 120 after the first dose. Antibody levels for HPV6/11/16/18 were evaluated using the competitive Luminex immunoassay (cLIA) and total immunoglobulin G assay. Geometric mean titers (GMTs) and seropositivity rates were compared between the different groups at different time points. Noninferiority of GMT ratios was defined as the lower bound of the 2-sided 95% confidence interval (CI) being greater than 0.5. Kinetics of antibody titers over time among study groups were examined.
RESULTS


At 120 months, data from 35 2D girls, 38 3D girls, and 30 3D women were used for analyses. cLIA seropositivity rates were above 95% for all HPV vaccine types and all schedules, except HPV18, with the lowest seropositivity observed among 3D women (60.0%; 95% CI, 40.6%-77.3%). GMT ratios (cLIA) for both 2D and 3D girls were noninferior to 3 doses in women for HPV6/11/16/18. Trends were comparable between assays.
CONCLUSIONS


GMTs for HPV6/11/16/18 after 2D or 3D of 4vHPV in girls were noninferior to 3D in adult women up to 120 months postvaccination. This study demonstrates long-term immunogenicity of the 2D HPV vaccine schedule.",2020,"cLIA seropositivity rates were above 95% for all HPV vaccine types and all schedules, except HPV18, with the lowest seropositivity observed among 3D women (60.0%; 95% CI, 40.6%-77.3%).","['35 2D girls, 38 3D girls, and 30 3D women', 'Girls aged 9-13 years']","['Quadrivalent Human Papillomavirus Vaccine', 'quadrivalent vaccine (4vHPV']","['GMT ratios (cLIA', 'Antibody levels', 'Kinetics of antibody titers', 'cLIA seropositivity rates', 'GMT ratios', 'Immunogenicity', 'Geometric mean titers (GMTs) and seropositivity rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",,0.15292,"cLIA seropositivity rates were above 95% for all HPV vaccine types and all schedules, except HPV18, with the lowest seropositivity observed among 3D women (60.0%; 95% CI, 40.6%-77.3%).","[{'ForeName': 'Robine', 'Initials': 'R', 'LastName': 'Donken', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Simon R M', 'Initials': 'SRM', 'LastName': 'Dobson', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Kim D', 'Initials': 'KD', 'LastName': 'Marty', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Darrel', 'Initials': 'D', 'LastName': 'Cook', 'Affiliation': 'Public Health Laboratory, BC Centre for Disease Control, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Sauvageau', 'Affiliation': 'Institut National de Sante Publique du Quebec, Quebec, Canada.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Gilca', 'Affiliation': 'Institut National de Sante Publique du Quebec, Quebec, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dionne', 'Affiliation': 'Department of Social and Preventive Medicine, Laval University, Quebec, Canada.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'McNeil', 'Affiliation': 'Canadian Center for Vaccinology, IWK Health Centre and Nova Scotia Health Authority, Dalhousie University, Nova Scotia, Canada.'}, {'ForeName': 'Mel', 'Initials': 'M', 'LastName': 'Krajden', 'Affiliation': 'Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Money', 'Affiliation': ""Women's Health Research Institute, BC Women's Hospital and Health Service, Vancouver, British Columbia, Canada.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kellner', 'Affiliation': ""Alberta Children's Hospital Infectious Diseases Epidemiology & Vaccine Evaluation Team, Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Scheifele', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Kollmann', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Bettinger', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Naus', 'Affiliation': 'Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Sadarangani', 'Affiliation': ""Vaccine Evaluation Center, BC Children's Hospital Research Institute, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Gina S', 'Initials': 'GS', 'LastName': 'Ogilvie', 'Affiliation': ""Women's Health Research Institute, BC Women's Hospital and Health Service, Vancouver, British Columbia, Canada.""}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz887']
878,29262693,A Randomized Controlled Trial of Multiple Versions of an Acceptance and Commitment Therapy Matrix App for Well-Being.,"Mobile apps may be useful in teaching psychological skills in a high-frequency, low-intensity intervention. The acceptance and commitment therapy (ACT) matrix is a visual tool to help develop psychological flexibility by categorizing moment-to-moment experience and is well suited to a mobile app. This pilot study tested the effects of a simple and complex version of a novel app using the ACT matrix in two distinct samples: help-seeking individuals ( n  = 35) and students receiving SONA credit ( n  = 63). Findings indicated no differences between app conditions and a waitlist condition in the SONA credit sample. However, in the help-seeking sample, improvements were found on well-being and valued action in participants who used the app, with greater improvements and app adoption for those using a complex version with additional skills. A mobile app based on the ACT matrix has benefits for help-seeking individuals, but supplementary features may be necessary to support consistent use and benefits.",2019,"However, in the help-seeking sample, improvements were found on well-being and valued action in participants who used the app, with greater improvements and app adoption for those using a complex version with additional skills.",['two distinct samples: help-seeking individuals ( n = 35) and students receiving SONA credit ( n = 63'],"['simple and complex version of a novel app using the ACT matrix', 'ACT matrix']",[],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}]",[],63.0,0.0482813,"However, in the help-seeking sample, improvements were found on well-being and valued action in participants who used the app, with greater improvements and app adoption for those using a complex version with additional skills.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Krafft', 'Affiliation': 'Utah State University, Logan, UT, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Potts', 'Affiliation': 'Utah State University, Logan, UT, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Schoendorff', 'Affiliation': 'Contextual Psychology Institute, Mont-Saint-Hilaire, Quebec, Canada.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Levin', 'Affiliation': 'Utah State University, Logan, UT, USA.'}]",Behavior modification,['10.1177/0145445517748561']
879,29570173,Gastric Emptying of Elemental Liquid Diets Versus Semisolid Diets in Bedridden Gastrostomy-fed Patients.,"BACKGROUND


Aspiration is a common problem in bedridden gastrostomy-fed patients. We compared gastric emptying of an elemental liquid diet and a commercial semisolid diet in bedridden gastrostomy-fed patients.
METHODS


Study 1: from January 2013 to December 2016, consecutive bedridden patients receiving percutaneous endoscopic gastrostomy (PEG) semisolid feeding hospitalized due to aspiration pneumonia were switched to elemental liquid diet feedings. The frequency of defecation, tube feed contents aspirated from the trachea, and aspiration pneumonia during hospitalization were retrospectively reviewed. Study 2 was a randomized, crossover trial comparing C sodium acetate gastric emptying of a commercial elemental liquid or a commercial semisolid diet in bedridden PEG patients and controls.
RESULTS


Study 1: 18 patients were enrolled. Elemental liquid diet was aspirated from the trachea in 1 (5.6%) (once in 24 observations); neither aspiration pneumonia nor diarrhea developed during elemental liquid diet feeding over 2 weeks observation. Study 2: 8 PEG patients and 8 healthy subjects were separately randomized to assess gastric emptying of the commercial elemental and semisolid diets. The elemental liquid diet was associated with a significant decrease of the 10%, 30%, or 50% emptying (excretion) time (P<0.05) and an increased the area under the curve (% dose/h) compared with the commercial semisolid diet (P<0.05). In healthy subjects there was no significant difference in gastric empting between the 2 diets.
CONCLUSIONS


Elemental liquid diets emptied more rapidly from the stomach than semisolid diets in bedridden PEG patients. They may prevent or reduce aspiration pneumonia compared with semisolid diets.",2019,"The elemental liquid diet was associated with a significant decrease of the 10%, 30%, or 50% emptying (excretion) time (P<0.05) and an increased the area under the curve (% dose/h) compared with the commercial semisolid diet (P<0.05).","['bedridden PEG patients and controls', 'healthy subjects', 'bedridden PEG patients', 'Bedridden Gastrostomy-fed Patients', 'feeding hospitalized due to aspiration pneumonia', 'Study 2: 8 PEG patients and 8 healthy subjects', 'Study 1: 18 patients were enrolled', 'Study 1: from January 2013 to December 2016, consecutive bedridden patients receiving', 'bedridden gastrostomy-fed patients']","['Elemental Liquid Diets Versus Semisolid Diets', 'C sodium acetate gastric emptying of a commercial elemental liquid or a commercial semisolid diet', 'percutaneous endoscopic gastrostomy (PEG) semisolid', 'elemental liquid diet and a commercial semisolid diet']","['gastric empting', 'aspiration pneumonia nor diarrhea', 'gastric emptying', 'emptying (excretion) time']","[{'cui': 'C0741453', 'cui_str': 'Bedridden'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0017196', 'cui_str': 'Gastrostomy'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0032290', 'cui_str': 'Aspiration Pneumonia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4321409', 'cui_str': 'Person, Non-Mobile'}]","[{'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0301569', 'cui_str': 'Soft food diet'}, {'cui': 'C0142785', 'cui_str': 'Sodium Acetate'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0176751', 'cui_str': 'Percutaneous endoscopic gastrostomy (procedure)'}]","[{'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0032290', 'cui_str': 'Aspiration Pneumonia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0017127', 'cui_str': 'Gastric Emptyings'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0219152,"The elemental liquid diet was associated with a significant decrease of the 10%, 30%, or 50% emptying (excretion) time (P<0.05) and an increased the area under the curve (% dose/h) compared with the commercial semisolid diet (P<0.05).","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Horiuchi', 'Affiliation': 'Digestive Disease Center.'}, {'ForeName': 'Ryosei', 'Initials': 'R', 'LastName': 'Sakai', 'Affiliation': 'Institute for Innovation, Ajinomoto Co. Inc., Kawasaki, Japan.'}, {'ForeName': 'Michio', 'Initials': 'M', 'LastName': 'Tamaki', 'Affiliation': 'Digestive Disease Center.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kajiyama', 'Affiliation': 'Digestive Disease Center.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Digestive Disease Center.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Morikawa', 'Affiliation': 'Department of Surgery, Showa Inan General Hospital, Komagane.'}]",Journal of clinical gastroenterology,['10.1097/MCG.0000000000001028']
880,31620886,Daily intake of heat-killed Lactobacillus plantarum L-137 improves inflammation and lipid metabolism in overweight healthy adults: a randomized-controlled trial.,"PURPOSE


The effects of heat-killed Lactobacillus plantarum L-137 (HK L-137) on inflammation and lipid metabolism were investigated in overweight volunteers.
METHODS


One hundred healthy subjects with a body mass index from 23.0 to 29.9 (51 men and 49 women; mean age: 41.4 years) were enrolled in this randomized, double-blind, placebo-controlled, parallel group study. Subjects were randomly assigned to daily administration of a tablet containing HK L-137 (10 mg) or a placebo tablet for 12 weeks. Blood samples were collected every 4 weeks to measure biomarkers of lipid metabolism and inflammatory mediators.
RESULTS


The percent change of concanavalin A-induced proliferation of peripheral blood mononuclear cells was significantly larger in the HK L-137 group than in the control group, similar to previous studies. The decreases of aspartate aminotransferase and alanine aminotransferase over time were significantly larger in the HK L-137 group than in the control group, as were the decreases of total cholesterol, low-density lipoprotein cholesterol, and the leukocyte count at one time point. These effects of HK L-137 were stronger in the subjects with higher C-reactive protein levels.
CONCLUSIONS


These findings suggest that daily intake of HK L-137 can improve inflammation and lipid metabolism in subjects at risk of inflammation.",2020,"The decreases of aspartate aminotransferase and alanine aminotransferase over time were significantly larger in the HK L-137 group than in the control group, as were the decreases of total cholesterol, low-density lipoprotein cholesterol, and the leukocyte count at one time point.","['overweight volunteers', 'subjects at risk of inflammation', 'One hundred healthy subjects with a body mass index from 23.0 to 29.9 (51 men and 49 women; mean age: 41.4\xa0years', 'overweight healthy adults']","['heat-killed Lactobacillus plantarum L-137 (HK L-137', 'HK L-137', 'tablet containing HK L-137', 'placebo', 'placebo tablet', 'heat-killed Lactobacillus plantarum L-137']","['peripheral blood mononuclear cells', 'aspartate aminotransferase and alanine aminotransferase over time', 'inflammation and lipid metabolism', 'total cholesterol, low-density lipoprotein cholesterol, and the leukocyte count']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C4521763', 'cui_str': 'Killed'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}]",100.0,0.143037,"The decreases of aspartate aminotransferase and alanine aminotransferase over time were significantly larger in the HK L-137 group than in the control group, as were the decreases of total cholesterol, low-density lipoprotein cholesterol, and the leukocyte count at one time point.","[{'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Research Division, Research and Development Institute, House Wellness Foods Corp., Imoji 3-20, Itami, Hyogo, 664-0011, Japan. Tanaka_Yuusuke@house-wf.co.jp.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Hirose', 'Affiliation': 'Research Division, Research and Development Institute, House Wellness Foods Corp., Imoji 3-20, Itami, Hyogo, 664-0011, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Yamamoto', 'Affiliation': 'Research Division, Research and Development Institute, House Wellness Foods Corp., Imoji 3-20, Itami, Hyogo, 664-0011, Japan.'}, {'ForeName': 'Yasunobu', 'Initials': 'Y', 'LastName': 'Yoshikai', 'Affiliation': 'Division of Host Defense, Medical Institute of Bioregulation, Kyushu University, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Murosaki', 'Affiliation': 'Research Division, Research and Development Institute, House Wellness Foods Corp., Imoji 3-20, Itami, Hyogo, 664-0011, Japan.'}]",European journal of nutrition,['10.1007/s00394-019-02112-3']
881,29276837,Effects of Behavioral Activation on the Quality of Life and Emotional State of Lung Cancer and Breast Cancer Patients During Chemotherapy Treatment.,"Research suggests that the progressive abandonment of activities in cancer patients are related to depression and worse quality of life. Behavioral activation (BA) encourages subjects to activate their sources of reinforcement and modify the avoidance responses. This study assesses the effectiveness of BA in improving quality of life and preventing emotional disorders during chemotherapy treatment. One sample of lung cancer patients and another of breast cancer patients were randomized into a BA experimental group (E.G. lung/4sess . n  = 50; E.G. breast/6sess . n  = 33) and a control group (C.G. lung/4sess . n  = 40; C.G. breast/6sess. n  = 35), respectively. In each session and in follow-ups (3/6/9 months), all participants completed different assessment scales. The results converge to show the effectiveness of BA, encouraging cancer patients to maintain rewarding activities which can activate their sources of day-to-day reinforcement and modify their experience avoidance patterns. BA appears to be a practical intervention which may improve social and role functioning and the emotional state of cancer patients during chemotherapy treatment.",2019,BA appears to be a practical intervention which may improve social and role functioning and the emotional state of cancer patients during chemotherapy treatment.,"['n = 50', 'lung cancer patients and another of breast cancer patients', 'Lung Cancer and Breast Cancer Patients', 'cancer patients', 'n = 40']","['BA', 'Behavioral Activation']","['Quality of Life and Emotional State', 'quality of life and preventing emotional disorders']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",[],"[{'cui': 'C0034380'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}]",,0.0171,BA appears to be a practical intervention which may improve social and role functioning and the emotional state of cancer patients during chemotherapy treatment.,"[{'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Fernández-Rodríguez', 'Affiliation': 'University of Oviedo, Spain.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Villoria-Fernández', 'Affiliation': 'Universidad Autónoma de Chile, Chile.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Fernández-García', 'Affiliation': 'University of Oviedo, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'González-Fernández', 'Affiliation': 'University of Oviedo, Spain.'}, {'ForeName': 'Marino', 'Initials': 'M', 'LastName': 'Pérez-Álvarez', 'Affiliation': 'University of Oviedo, Spain.'}]",Behavior modification,['10.1177/0145445517746915']
882,31580931,Effects of stress-induced inflammation on reward processing in healthy young women.,"BACKGROUND


Anhedonia, or loss of interest or pleasure, is a feature of depression and transdiagnostic construct in psychopathology. Theory and compelling evidence from preclinical models implicates stress-induced inflammation as a psychobiological pathway to anhedonic behavior; however, this pathway has not been tested in human models. Further, although anhedonia may reflect dysregulation in multiple dimensions of reward, the extent to which stress-induced inflammation alters these dimensions is unclear. Thus, the current experimental study used a standardized laboratory stressor task to elicit an inflammatory response and evaluate effects of stress-induced inflammation on multiple behavioral indices of reward processing.
METHODS


Healthy young women (age 18-25) completed behavioral reward tasks assessing reward learning, motivation, and sensitivity and were randomized to undergo an acute psychosocial stressor (n = 37) or a no-stress active control (n = 17). Tasks were re-administered 90-120 min post-stress to coincide with the peak of the stress-induced inflammatory response. Blood samples were collected for assessment of the pro-inflammatory cytokine interleukin-6 (IL-6) at baseline and 90 and 120 min post stressor.
RESULTS


Stress-induced IL-6 was associated with increased response bias during reward learning and increased motivation when probability of receiving a reward was low. Sensitivity to reward in the context of a motivation task was not altered in association with stress-induced IL-6.
CONCLUSIONS


Contrary to hypotheses, mild increases in IL-6 following acute stress were associated with increased reward responsiveness during reward learning and selective increases in motivation. Results contribute to an emerging and nuanced literature linking inflammation to reward processing, and demonstrate that behavioral effects of stress-induced inflammation may be detected in the laboratory setting.
CLINICAL TRIAL REGISTRATION


NCT03828604.",2020,"RESULTS


Stress-induced IL-6 was associated with increased response bias during reward learning and increased motivation when probability of receiving a reward was low.","['Healthy Young Women', 'Healthy young women (age 18-25) completed']","['Stress-Induced Inflammation', 'behavioral reward tasks assessing reward learning, motivation, and sensitivity and were randomized to undergo an acute psychosocial stressor (n = 37) or a no-stress active control']",['reward responsiveness during reward learning and selective increases in motivation'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.0614676,"RESULTS


Stress-induced IL-6 was associated with increased response bias during reward learning and increased motivation when probability of receiving a reward was low.","[{'ForeName': 'Chloe C', 'Initials': 'CC', 'LastName': 'Boyle', 'Affiliation': 'Norman Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA 90095, United States. Electronic address: ccboyle@ucla.edu.'}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Stanton', 'Affiliation': 'Norman Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA 90095, United States; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA 90095, United States; Department of Psychology, University of California, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Naomi I', 'Initials': 'NI', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Teresa E', 'Initials': 'TE', 'LastName': 'Seeman', 'Affiliation': 'Geffen School of Medicine, University of California, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Julienne E', 'Initials': 'JE', 'LastName': 'Bower', 'Affiliation': 'Norman Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA 90095, United States; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA 90095, United States; Department of Psychology, University of California, Los Angeles, CA 90095, United States.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.09.023']
883,31461801,Intrathecal dexmedetomidine versus magnesium sulphate for postoperative analgesia and stress response after caesarean delivery; randomized controlled double-blind study.,"BACKGROUND


Various adjuvants were added to intrathecal anaesthetics to improve quality of the block and postoperative analgesia. We hypothesized that intrathecal dexmedetomidine and magnesium sulphate (MgSO 4  ) may add similar effects. Our objectives were to compare their effects as adjuvants to intrathecal bupivacaine on postoperative analgesia, stress hormones, sedative properties and the neonatal outcome after caesarean section.
METHODS


A randomized double-blind controlled study; 90 parturients were divided into three groups. All patients received intrathecal hyperbaric bupivacaine 12.5 mg. NaCl 0.9% was added to intrathecal block in group C, 5 μg dexmedetomidine in the group D and 50 mg MgSO 4  in group M. Visual analogue scale (VAS) score, stress hormones were assessed within the first 12 postoperative hours, sensory block, and neonatal outcome were also assessed.
RESULTS


VAS scores were significantly lower in groups D and M. Onset of postoperative pain was significantly prolonged in group D. Time to peak sensory level was shorter in group D. Sedation score was significantly higher in group D only after 30 min of intrathecal block. Although stress hormones increased in all groups during intraoperative and postoperative periods, their levels were significantly lower in group D compared to other groups. No differences were noted regarding neonatal outcomes.
CONCLUSION


Intrathecal dexmedetomidine is superior to intrathecal MgSO 4  during caesarean section with regard to duration of analgesia, pain severity and stress hormone levels. Dexmedetomidine has a rapid onset and longer duration of sensory block compared to MgSO 4  . No significant adverse effects to the parturients or newborns.",2020,"RESULTS


VAS scores were significantly lower in groups D & M. Onset of postoperative pain was significantly prolonged in group D. Time to peak sensory level was shorter in group D. Sedation score was significantly higher in group D only after 30 minutes of intrathecal block.",[' ninety parturients'],"['intrathecal hyperbaric bupivacaine', 'magnesium sulfate', 'Intrathecal dexmedetomidine', 'Dexmedetomidine', 'dexmedetomidine', 'intrathecal dexmedetomidine and magnesium sulfate (MgSO 4  ', 'intrathecal bupivacaine']","['postoperative analgesia, stress hormones, sedative properties and the neonatal outcome', 'peak sensory level', 'postoperative pain', 'stress hormones', 'VAS scores', 'Visual analogue scale (VAS) score, stress hormones', 'neonatal outcomes', 'adverse effects', 'duration of analgesia, pain severity, and stress hormone levels', 'postoperative analgesia and stress response', 'Sedation score']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1262068', 'cui_str': 'Sensory level'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",,0.255791,"RESULTS


VAS scores were significantly lower in groups D & M. Onset of postoperative pain was significantly prolonged in group D. Time to peak sensory level was shorter in group D. Sedation score was significantly higher in group D only after 30 minutes of intrathecal block.","[{'ForeName': 'Mohamed F', 'Initials': 'MF', 'LastName': 'Mostafa', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ragaa', 'Initials': 'R', 'LastName': 'Herdan', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Golnar M', 'Initials': 'GM', 'LastName': 'Fathy', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Zein E A Zareh', 'Initials': 'ZEAZ', 'LastName': 'Hassan', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Galal', 'Affiliation': 'Department of Clinical Pathology, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Talaat', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Assiut University, Assiut, Egypt.'}, {'ForeName': 'Ahmed K', 'Initials': 'AK', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Public Health, Faculty of Medicine, Assiut University, Assiut, Egypt.'}]","European journal of pain (London, England)",['10.1002/ejp.1476']
884,23177901,"Health-risk behaviors among a sample of US pre-adolescents: types, frequency, and predictive factors.","BACKGROUND


Children as young as 10 years old report curiosity and participation in health-risk behaviors, yet most studies focus upon adolescent samples.
OBJECTIVE


To document the types and frequencies of health risk behavior among pre-adolescents and to examine the child, family, and environment factors that predict them.
METHOD


A sample of 297 pre-adolescents (mean age=10.5, SD=0.6) from two Midwestern US cities and their parents (child-parent dyads) provided data about demographic characteristics, health risk behavior participation, child self-esteem, child pubertal development, child and adult perception of their neighborhood, and parent monitoring. Their participation was at intake to a 5-year clustered randomized controlled trial.
RESULTS


Pre-adolescents participated in an average of 3.7 health-risk behaviors (SD=2.0), primarily those that lead to unintentional (helmet and seatbelt use) and intentional (feeling unsafe, having something stolen, and physical fighting) injury. Factors predictive of unintentional injury risk behavior were self-esteem, pubertal development, parent monitoring, and parent perception of the neighborhood environment. Boys were 1.8 times less likely than girls to use helmets and seatbelts. Pre-adolescents whose parents were not partnered were 2.8 times more likely than pre-adolescents whose parents were partnered to report intentional risk behavior.
RECOMMENDATIONS


These data demonstrate trends that cannot be ignored. We recommend, focused specifically upon boys and non-partnered families that (a) developmentally appropriate, appealing prevention messages be developed and delivered for parents and pre-adolescents and community interventions targeting both parent and pre-adolescent together be provided to help them establish and monitor behavioral expectations and (b) organized nursing endorse policy in the US and globally that assures adequate family environments for children.",2013,"adolescents whose parents were not partnered were 2.8 times more likely than pre-adolescents whose parents were partnered to report intentional risk behavior.
","['A sample of 297 pre-adolescents (mean age=10.5, SD=0.6) from two Midwestern US cities and their parents (child-parent dyads) provided data about demographic characteristics, health risk behavior participation, child self-esteem, child pubertal development, child and adult perception of their neighborhood, and parent monitoring', 'Children as young as 10 years old report curiosity and participation in health-risk behaviors', 'Pre-adolescents participated in an average of 3.7 health-risk behaviors (SD=2.0), primarily those that lead to unintentional (helmet and seatbelt use) and intentional (feeling unsafe, having something stolen, and physical fighting) injury', 'children']",[],['Health-risk behaviors'],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C4505097', 'cui_str': 'Health Risk Behaviors'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0010472', 'cui_str': 'Curiosity'}, {'cui': 'C4517696', 'cui_str': '3.7 (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1283932', 'cui_str': 'Unintentional'}, {'cui': 'C0018884', 'cui_str': 'Helmets'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0039751', 'cui_str': 'Stealing'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0424324', 'cui_str': 'Fighting (finding)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",[],"[{'cui': 'C4505097', 'cui_str': 'Health Risk Behaviors'}]",297.0,0.0333489,"adolescents whose parents were not partnered were 2.8 times more likely than pre-adolescents whose parents were partnered to report intentional risk behavior.
","[{'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Riesch', 'Affiliation': 'School of Nursing, University of Wisconsin-Madison, Madison, WI, USA. skriesch@wisc.edu'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kedrowski', 'Affiliation': ''}, {'ForeName': 'Roger L', 'Initials': 'RL', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Barbara Myers', 'Initials': 'BM', 'LastName': 'Temkin', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Henriques', 'Affiliation': ''}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Jacobson', 'Affiliation': ''}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Giustino-Kluba', 'Affiliation': ''}]",International journal of nursing studies,['10.1016/j.ijnurstu.2012.10.012']
885,28655015,Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial.,"Importance


Acupuncture is used to induce ovulation in some women with polycystic ovary syndrome, without supporting clinical evidence.
Objective


To assess whether active acupuncture, either alone or combined with clomiphene, increases the likelihood of live births among women with polycystic ovary syndrome.
Design, Setting, and Participants


A double-blind (clomiphene vs placebo), single-blind (active vs control acupuncture) factorial trial was conducted at 21 sites (27 hospitals) in mainland China between July 6, 2012, and November 18, 2014, with 10 months of pregnancy follow-up until October 7, 2015. Chinese women with polycystic ovary syndrome were randomized in a 1:1:1:1 ratio to 4 groups.
Interventions


Active or control acupuncture administered twice a week for 30 minutes per treatment and clomiphene or placebo administered for 5 days per cycle, for up to 4 cycles. The active acupuncture group received deep needle insertion with combined manual and low-frequency electrical stimulation; the control acupuncture group received superficial needle insertion, no manual stimulation, and mock electricity.
Main Outcomes and Measures


The primary outcome was live birth. Secondary outcomes included adverse events.
Results


Among the 1000 randomized women (mean [SD] age, 27.9 [3.3] years; mean [SD] body mass index, 24.2 [4.3]), 250 were randomized to each group; a total of 926 women (92.6%) completed the trial. Live births occurred in 69 of 235 women (29.4%) in the active acupuncture plus clomiphene group, 66 of 236 (28.0%) in the control acupuncture plus clomiphene group, 31 of 223 (13.9%) in the active acupuncture plus placebo group, and 39 of 232 (16.8%) in the control acupuncture plus placebo group. There was no significant interaction between active acupuncture and clomiphene (P = .39), so main effects were evaluated. The live birth rate was significantly higher in the women treated with clomiphene than with placebo (135 of 471 [28.7%] vs 70 of 455 [15.4%], respectively; difference, 13.3%; 95% CI, 8.0% to 18.5%) and not significantly different between women treated with active vs control acupuncture (100 of 458 [21.8%] vs 105 of 468 [22.4%], respectively; difference, -0.6%; 95% CI, -5.9% to 4.7%). Diarrhea and bruising were more common in patients receiving active acupuncture than control acupuncture (diarrhea: 25 of 500 [5.0%] vs 8 of 500 [1.6%], respectively; difference, 3.4%; 95% CI, 1.2% to 5.6%; bruising: 37 of 500 [7.4%] vs 9 of 500 [1.8%], respectively; difference, 5.6%; 95% CI, 3.0% to 8.2%).
Conclusions and Relevance


Among Chinese women with polycystic ovary syndrome, the use of acupuncture with or without clomiphene, compared with control acupuncture and placebo, did not increase live births. This finding does not support acupuncture as an infertility treatment in such women.
Trial Registration


clinicaltrials.gov Identifier: NCT01573858.",2017,"There was no significant interaction between active acupuncture and clomiphene (P = .39), so main effects were evaluated.","['women with polycystic ovary syndrome', '21 sites (27 hospitals) in mainland China between July 6, 2012, and November 18, 2014, with 10 months of pregnancy follow-up until October 7, 2015', '1000 randomized women (mean [SD] age, 27.9 [3.3] years; mean [SD] body mass index, 24.2 [4.3]), 250 were randomized to each group; a total of 926 women (92.6%) completed the trial', 'Chinese Women With Polycystic Ovary Syndrome', 'Chinese women with polycystic ovary syndrome']","['Interventions\n\n\nActive or control acupuncture', 'Acupuncture', 'clomiphene or placebo', 'placebo', 'active acupuncture', 'Acupuncture and Clomiphene', 'acupuncture plus clomiphene', 'acupuncture', 'double-blind (clomiphene vs placebo', 'deep needle insertion with combined manual and low-frequency electrical stimulation; the control acupuncture group received superficial needle insertion, no manual stimulation, and mock electricity', 'acupuncture plus placebo', 'control acupuncture plus placebo', 'acupuncture with or without clomiphene', 'clomiphene', 'control acupuncture plus clomiphene', 'control acupuncture and placebo', 'active acupuncture, either alone or combined with clomiphene', 'control acupuncture']","['Diarrhea and bruising', 'live birth', 'Live births', 'adverse events', 'live birth rate', 'live births', 'likelihood of live births']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517688', 'cui_str': '3.3 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009008', 'cui_str': 'Clomiphene'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0562577', 'cui_str': 'Mocking (finding)'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",926.0,0.788628,"There was no significant interaction between active acupuncture and clomiphene (P = .39), so main effects were evaluated.","[{'ForeName': 'Xiao-Ke', 'Initials': 'XK', 'LastName': 'Wu', 'Affiliation': 'Committee of Reproductive Medicine, World Federation of Chinese Medicine Societies, Beijing, China2Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Stener-Victorin', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China3Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Hong-Ying', 'Initials': 'HY', 'LastName': 'Kuang', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Hong-Li', 'Initials': 'HL', 'LastName': 'Ma', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Jing-Shu', 'Initials': 'JS', 'LastName': 'Gao', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Liang-Zhen', 'Initials': 'LZ', 'LastName': 'Xie', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Li-Hui', 'Initials': 'LH', 'LastName': 'Hou', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Zhen-Xing', 'Initials': 'ZX', 'LastName': 'Hu', 'Affiliation': ""Outpatient Department, Xuzhou Maternal and Children's Hospital, Xuzhou, China.""}, {'ForeName': 'Xiao-Guang', 'Initials': 'XG', 'LastName': 'Shao', 'Affiliation': ""Centre for Reproductive Medicine, Dalian Maternal and Children's Centre, Dalian, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': ""Department of Infertility, Tanggu District Maternal and Children's Hospital, Tianjin, China.""}, {'ForeName': 'Jin-Feng', 'Initials': 'JF', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Shanxi Province Hospital of Chinese Medicine, Taiyuan, China.'}, {'ForeName': 'Hui-Ying', 'Initials': 'HY', 'LastName': 'Xue', 'Affiliation': ""Centre for Reproductive Medicine, Huaian Maternal and Children's Hospital, Huaian, China.""}, {'ForeName': 'Xiao-Feng', 'Initials': 'XF', 'LastName': 'Xu', 'Affiliation': 'Department of Gynecology, Suzhou City Hospital of Chinese Medicine, Suzhou, China.'}, {'ForeName': 'Rui-Ning', 'Initials': 'RN', 'LastName': 'Liang', 'Affiliation': 'Department of Gynecology, Second Hospital, Jiangxi University of Chinese Medicine, Nanchang, China.'}, {'ForeName': 'Hong-Xia', 'Initials': 'HX', 'LastName': 'Ma', 'Affiliation': 'Department of Chinese Medicine, First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Hong-Wei', 'Initials': 'HW', 'LastName': 'Yang', 'Affiliation': 'Department of Infertility, Liwan District Hospital of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Wei-Li', 'Initials': 'WL', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Affiliated Hospital, Anhui University of Chinese Medicine, Hefei, China.'}, {'ForeName': 'Dong-Mei', 'Initials': 'DM', 'LastName': 'Huang', 'Affiliation': 'Institute of Integrated Traditional and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Gynecology, Wenzhou City Hospital of Chinese Medicine, Wenzhou, China.'}, {'ForeName': 'Cui-Fang', 'Initials': 'CF', 'LastName': 'Hao', 'Affiliation': 'Centre for Reproductive Medicine, Yuhuangding Hospital, Yantai, China.'}, {'ForeName': 'Shao-Min', 'Initials': 'SM', 'LastName': 'Du', 'Affiliation': 'Department of Obstetrics and Gynecology, Daqing Longnan Hospital, Daqing, China.'}, {'ForeName': 'Zheng-Wang', 'Initials': 'ZW', 'LastName': 'Yang', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Hunan University of Chinese Medicine, Changsha, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Liaoning University of Chinese Medicine, Shenyang, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Department of Gynecology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.'}, {'ForeName': 'Xiu-Hua', 'Initials': 'XH', 'LastName': 'Chen', 'Affiliation': 'Department of Traditional Technology, Guangdong Province Hospital of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Fu', 'Affiliation': 'Department of Gynecology, Hangzhou City Hospital of Chinese Medicine, Hangzhou, China.'}, {'ForeName': 'Cai-Fei', 'Initials': 'CF', 'LastName': 'Ding', 'Affiliation': 'Centre for Reproductive Medicine, Zhejiang Province Hospital of Integrative Medicine, Hangzhou, China.'}, {'ForeName': 'Ya-Qin', 'Initials': 'YQ', 'LastName': 'Gao', 'Affiliation': 'Centre for Reproductive Medicine, Daqing Oilfield General Hospital, Daqing, China.'}, {'ForeName': 'Zhong-Ming', 'Initials': 'ZM', 'LastName': 'Zhou', 'Affiliation': 'Department of Obstetrics and Gynecology, Hubei Province Hospital of Chinese Medicine, Wuhan, China.'}, {'ForeName': 'Chi Chiu', 'Initials': 'CC', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, The Chinese University of Hong Kong, Hong Kong, China27Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Hong Kong, China28School of Biomedical Sciences, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Tai-Xiang', 'Initials': 'TX', 'LastName': 'Wu', 'Affiliation': 'Chinese Clinical Trial Registry, Shenzhen, China.'}, {'ForeName': 'Jian-Ping', 'Initials': 'JP', 'LastName': 'Liu', 'Affiliation': 'Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ernest H Y', 'Initials': 'EHY', 'LastName': 'Ng', 'Affiliation': 'Department of Obstetrics and Gynecology, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China32Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2017.7217']
886,31596461,"Perioperative Gabapentin in Pediatric Thoracic Surgery Patients-Randomized, Placebo-Controlled, Phase 4 Trial.","OBJECTIVE


To determine whether the use of perioperative gabapentin reduces postoperative pain and anxiety, decreases ropivacaine consumption and side effects, and improves patient satisfaction.
DESIGN


Randomized, placebo-controlled, phase 4 trial.
BLINDING


Participants, care providers, investigators, data analysts.
SETTING


Department of Thoracic Surgery of the Institute of Tuberculosis and Lung Disease, Rabka Zdrój Branch, Poland.
SUBJECTS


Forty patients undergoing the Ravitch procedure.
METHODS


Patients aged nine to 17 years were randomized into a gabapentin (preoperative 15 mg/kg, treatment) or placebo group. Postoperative analgesia included gabapentin (7.5 mg/kg) or placebo two times per day for three days, epidural ropivacaine + fentanyl, paracetamol, nonsteroidal anti-inflammatory drugs, and metamizol as a ""rescue drug."" Pain, anxiety, analgesic consumption, side effects, and patient satisfaction were recorded.
RESULTS


There was no statistically significant difference in median pain scores (numerical rating scale < 1/10) or incidence of adverse side effects between the gabapentin group (N = 20) and the placebo group (N = 20). Postoperative anxiety scores were significantly lower than before surgery in the gabapentin group (6 [4-8] vs 7 [6-8.5], P < 0.01) and remained unchanged in the placebo group (6 [5-6.5] vs 6 [5-7], P = 0.07). Gabapentin-treated patients received a lower number of doses of ondansetron when compared with the placebo group (6 [5-6] vs 7 [6-9], P = 0.02). A significant negative association was found between patient satisfaction and postoperative state anxiety in the gabapentin group (R = -0.51, P = 0.02).
CONCLUSIONS


Perioperative administration of gabapentin resulted in a decrease of postoperative anxiety in pediatric patients undergoing the Ravitch procedure.",2020,There was no statistically significant difference in median pain scores (numerical rating scale < 1/10) or incidence of adverse side effects between the gabapentin group (N = 20) and the placebo group (N = 20).,"['Forty patients undergoing the Ravitch procedure', 'Participants, care providers, investigators, data analysts', 'pediatric patients undergoing the Ravitch procedure', 'Patients aged nine to 17\u2009years', 'Pediatric Thoracic Surgery Patients-Randomized', 'Department of Thoracic Surgery of the Institute of Tuberculosis and Lung Disease, Rabka Zdrój Branch, Poland']","['Perioperative Gabapentin', 'gabapentin', 'Placebo', 'ondansetron', 'ropivacaine + fentanyl, paracetamol, nonsteroidal anti-inflammatory drugs, and metamizol', 'placebo', 'perioperative gabapentin', 'Gabapentin']","['Postoperative anxiety scores', 'postoperative anxiety', 'adverse side effects', 'Pain, anxiety, analgesic consumption, side effects, and patient satisfaction', 'postoperative pain and anxiety, decreases ropivacaine consumption and side effects', 'median pain scores', 'patient satisfaction and postoperative state anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0039986', 'cui_str': 'Thoracic Surgery'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C0205384', 'cui_str': 'Branching (qualifier value)'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0012586', 'cui_str': 'Metamizole'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0231287', 'cui_str': 'Postoperative state (finding)'}]",40.0,0.757022,There was no statistically significant difference in median pain scores (numerical rating scale < 1/10) or incidence of adverse side effects between the gabapentin group (N = 20) and the placebo group (N = 20).,"[{'ForeName': 'Lucyna', 'Initials': 'L', 'LastName': 'Tomaszek', 'Affiliation': 'Department of Thoracic Surgery, Institute of Tuberculosis and Lung Diseases, Rabka-Zdrój Branch, Rabka-Zdrój, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Fenikowski', 'Affiliation': 'Department of Thoracic Surgery, Institute of Tuberculosis and Lung Diseases, Rabka-Zdrój Branch, Rabka-Zdrój, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Maciejewski', 'Affiliation': 'Department of Thoracic Surgery, Institute of Tuberculosis and Lung Diseases, Rabka-Zdrój Branch, Rabka-Zdrój, Poland.'}, {'ForeName': 'Halina', 'Initials': 'H', 'LastName': 'Komotajtys', 'Affiliation': 'Department of Thoracic Surgery, Institute of Tuberculosis and Lung Diseases, Rabka-Zdrój Branch, Rabka-Zdrój, Poland.'}, {'ForeName': 'Danuta', 'Initials': 'D', 'LastName': 'Gawron', 'Affiliation': 'Department of Thoracic Surgery, Institute of Tuberculosis and Lung Diseases, Rabka-Zdrój Branch, Rabka-Zdrój, Poland.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz207']
887,31563397,Efficacy of Systemic Steroid Use Given One Day After Total Knee Arthroplasty for Pain and Nausea: A Randomized Controlled Study.,"BACKGROUND


Systemic steroid has been used to control pain and nausea in total knee arthroplasty (TKA), but most studies recommend a single dose administration prior to, or during, surgery. This study aimed to determine the efficacy of administration on 1 day postoperatively.
METHODS


Patients who were scheduled to undergo TKA were randomly assigned to the following groups: control group, receiving normal saline injection; group 1, receiving 10 mg dexamethasone intravenously (IV) 1 hour before surgery; group 2, receiving 0.1 mg/kg dexamethasone (IV) 24 hours after surgery; or group 3, receiving 0.2 mg/kg dexamethasone (IV) 24 hours after surgery (n = 44-46 per group). Primary outcomes were pain and nausea visual analogue scale (VAS). Secondary outcomes were analgesic administration, rescue antiemetic administration, C-reactive protein, range of motion, and complications.
RESULTS


Postoperative pain and nausea remained high for 48 hours post-TKA. Group 1 had lower pain and nausea VAS scores than did the control group (P < .01) for only 24 hours post-TKA. Groups 2 and 3 had lower pain and nausea VAS scores than did the control group and group 1 (P < .01) 48 hours post-TKA. Analgesic and antiemetic administration were significantly lower in groups 2 and 3 than in the control group during 48 hours after TKA. There were no differences in C-reactive protein level and range of motion, and complications were not detected.
CONCLUSION


The effect of preoperative and postoperative administration of dexamethasone for controlling pain and nausea was observed only for 24 hours. Considering that severe pain and nausea persisted for more than 48 hours after TKA, additional administration of dexamethasone at 1 day postoperatively is suggested.
LEVEL OF EVIDENCE


Level I.",2020,Analgesic and antiemetic administration were significantly lower in groups 2 and 3 than in the control group during 48 hours after TKA.,"['Patients who were scheduled to undergo TKA', 'total knee arthroplasty (TKA']","['dexamethasone (IV', 'Total Knee Arthroplasty', 'dexamethasone', 'control group, receiving normal saline injection; group 1, receiving 10 mg dexamethasone intravenously (IV', 'Systemic Steroid Use Given One Day']","['C-reactive protein level and range of motion, and complications', 'pain and nausea', 'pain and nausea visual analogue scale (VAS', 'analgesic administration, rescue antiemetic administration, C-reactive protein, range of motion, and complications', 'Analgesic and antiemetic administration', 'lower pain and nausea VAS scores', 'Postoperative pain and nausea', 'Pain and Nausea', 'pain and nausea VAS scores', 'severe pain and nausea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0262176', 'cui_str': 'Administration of analgesic (procedure)'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic Drugs'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}]",,0.186059,Analgesic and antiemetic administration were significantly lower in groups 2 and 3 than in the control group during 48 hours after TKA.,"[{'ForeName': 'Jong-Keun', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Hanil General Hospital, Seoul, South Korea.'}, {'ForeName': 'Du Hyun', 'Initials': 'DH', 'LastName': 'Ro', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Han-Jin', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, Hanil General Hospital, Seoul, South Korea.'}, {'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyuk-Soo', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Myung Chul', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, Seoul, South Korea.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.08.026']
888,32412145,Mind and body: Psychophysiological profiles of instructional and motivational self-talk.,"Self-talk is a psychological skill that benefits motor performance by controlling and organizing performers' thoughts. While the behavioral effects of self-talk are clear, research on the mechanisms underpinning the effects of different modes of self-talk is sparse. To address this issue, we propose and test a psychophysiological model of the effects of self-talk on motor performance. Forty golf novices practiced a golf putting task while using either instructional or motivational self-talk preceding each putt. We measured performance (radial error), technique (club kinematics and muscle activity), cardiac activity (heart-rate and event-related heart-rate change), as well as electroencephalographic alpha power and connectivity in a randomized (group: instructional self-talk, motivational self-talk) experimental design. Instructional self-talk promoted superior technique and was associated with greater parietal alpha power and weaker connectivity between frontal and parietal electrodes and all other scalp sites, possibly indicative of increased top-down control of action. These findings provide initial evidence for an information-processing mechanism underlying the benefits of instructional self-talk. They also cast doubt on the validity of left-frontotemporal connectivity as a measure of verbal-analytic processing during motor tasks. Motivational self-talk led to increased heart-rate and reduced event-related heart rate variability, suggesting an effort-based mechanism to explain the benefits of motivational self-talk. Our study represents the most complete multi-measure investigation of self-talk to date. We hope that our psychophysiological model of self-talk will encourage researchers to move beyond the exclusive reliance on behavioral and self-report measures to discover the mechanisms underlying the benefits of self-talk for performance.",2020,"Instructional self-talk promoted superior technique and was associated with greater parietal alpha power and weaker connectivity between frontal and parietal electrodes and all other scalp sites, possibly indicative of increased top-down control of action.",[],['Mind and body'],"['instructional self-talk, motivational self-talk) experimental design', 'heart-rate', 'performance (radial error), technique (club kinematics and muscle activity), cardiac activity (heart-rate and event-related heart-rate change), as well as electroencephalographic alpha power and connectivity']",[],"[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443168', 'cui_str': 'Cardiac activity'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",,0.0162807,"Instructional self-talk promoted superior technique and was associated with greater parietal alpha power and weaker connectivity between frontal and parietal electrodes and all other scalp sites, possibly indicative of increased top-down control of action.","[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bellomo', 'Affiliation': 'Bangor University, Bangor, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cooke', 'Affiliation': 'Bangor University, Bangor, United Kingdom.'}, {'ForeName': 'Germano', 'Initials': 'G', 'LastName': 'Gallicchio', 'Affiliation': 'University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ring', 'Affiliation': 'University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hardy', 'Affiliation': 'Bangor University, Bangor, United Kingdom.'}]",Psychophysiology,['10.1111/psyp.13586']
889,28609534,Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency Anemia: A Randomized Clinical Trial.,"Importance


Iron-deficiency anemia (IDA) affects millions of persons worldwide, and is associated with impaired neurodevelopment in infants and children. Ferrous sulfate is the most commonly prescribed oral iron despite iron polysaccharide complex possibly being better tolerated.
Objective


To compare the effect of ferrous sulfate with iron polysaccharide complex on hemoglobin concentration in infants and children with nutritional IDA.
Design, Setting, and Participants


Double-blind, superiority randomized clinical trial of infants and children aged 9 to 48 months with nutritional IDA (assessed by history and laboratory criteria) that was conducted in an outpatient hematology clinic at a US tertiary care hospital from September 2013 through November 2015; 12-week follow-up ended in January 2016.
Interventions


Three mg/kg of elemental iron once daily as either ferrous sulfate drops or iron polysaccharide complex drops for 12 weeks.
Main Outcomes and Measures


Primary outcome was change in hemoglobin over 12 weeks. Secondary outcomes included complete resolution of IDA (defined as hemoglobin concentration >11 g/dL, mean corpuscular volume >70 fL, reticulocyte hemoglobin equivalent >25 pg, serum ferritin level >15 ng/mL, and total iron-binding capacity <425 μg/dL at the 12-week visit), changes in serum ferritin level and total iron-binding capacity, adverse effects.
Results


Of 80 randomized infants and children (median age, 22 months; 55% male; 61% Hispanic white; 40 per group), 59 completed the trial (28 [70%] in ferrous sulfate group; 31 [78%] in iron polysaccharide complex group). From baseline to 12 weeks, mean hemoglobin increased from 7.9 to 11.9 g/dL (ferrous sulfate group) vs 7.7 to 11.1 g/dL (iron complex group), a greater difference of 1.0 g/dL (95% CI, 0.4 to 1.6 g/dL; P < .001) with ferrous sulfate (based on a linear mixed model). Proportion with a complete resolution of IDA was higher in the ferrous sulfate group (29% vs 6%; P = .04). Median serum ferritin level increased from 3.0 to 15.6 ng/mL (ferrous sulfate) vs 2.0 to 7.5 ng/mL (iron complex) over 12 weeks, a greater difference of 10.2 ng/mL (95% CI, 6.2 to 14.1 ng/mL; P < .001) with ferrous sulfate. Mean total iron-binding capacity decreased from 501 to 389 μg/dL (ferrous sulfate) vs 506 to 417 μg/dL (iron complex) (a greater difference of -50 μg/dL [95% CI, -86 to -14 μg/dL] with ferrous sulfate; P < .001). There were more reports of diarrhea in the iron complex group than in the ferrous sulfate group (58% vs 35%, respectively; P = .04).
Conclusions and Relevance


Among infants and children aged 9 to 48 months with nutritional iron-deficiency anemia, ferrous sulfate compared with iron polysaccharide complex resulted in a greater increase in hemoglobin concentration at 12 weeks. Once daily, low-dose ferrous sulfate should be considered for children with nutritional iron-deficiency anemia.
Trial Registration


clinicaltrials.gov Identifier: NCT01904864.",2017,"Median serum ferritin level increased from 3.0 to 15.6 ng/mL (ferrous sulfate) vs 2.0 to 7.5 ng/mL (iron complex) over 12 weeks, a greater difference of 10.2 ng/mL (95% CI, 6.2 to 14.1 ng/mL; P < .001) with ferrous sulfate.","['infants and children aged 9 to 48 months with nutritional iron-deficiency anemia', 'With Nutritional Iron-Deficiency Anemia', 'Young Children', '80 randomized infants and children (median age, 22 months; 55% male; 61% Hispanic white; 40 per group', 'children with nutritional iron-deficiency anemia', 'infants and children with nutritional IDA', 'infants and children', 'infants and children aged 9 to 48 months with nutritional IDA (assessed by history and laboratory criteria) that was conducted in an outpatient hematology clinic at a US tertiary care hospital from September 2013 through November 2015; 12-week follow-up ended in January 2016']","['Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex', 'ferrous sulfate with iron polysaccharide complex', 'ferrous sulfate drops or iron polysaccharide complex drops', 'iron polysaccharide complex', 'Ferrous sulfate', 'ferrous sulfate']","['Mean total iron-binding capacity', 'hemoglobin concentration', 'Hemoglobin Concentration', 'diarrhea', 'mean hemoglobin', 'complete resolution of IDA (defined as hemoglobin concentration ', 'total iron-binding capacity', 'serum ferritin level and total iron-binding capacity, adverse effects', 'change in hemoglobin', 'serum ferritin level', 'complete resolution of IDA', 'Median serum ferritin level', 'mean corpuscular volume >70 fL, reticulocyte hemoglobin equivalent']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3839291', 'cui_str': 'Hematology clinic (environment)'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C0722705', 'cui_str': 'Iron polysaccharide'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0863148', 'cui_str': 'Erythrocyte mean corpuscular volume determination (procedure)'}, {'cui': 'C4049225', 'cui_str': 'Reticulocyte haemoglobin equivalent'}]",80.0,0.485,"Median serum ferritin level increased from 3.0 to 15.6 ng/mL (ferrous sulfate) vs 2.0 to 7.5 ng/mL (iron complex) over 12 weeks, a greater difference of 10.2 ng/mL (95% CI, 6.2 to 14.1 ng/mL; P < .001) with ferrous sulfate.","[{'ForeName': 'Jacquelyn M', 'Initials': 'JM', 'LastName': 'Powers', 'Affiliation': ""Division of Hematology and Oncology, Baylor College of Medicine, Houston, Texas2Department of Pediatrics, Baylor College of Medicine, Houston, Texas3Texas Children's Hospital, Houston.""}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Buchanan', 'Affiliation': ""Division of Hematology and Oncology, University of Texas Southwestern Medical Center, Dallas5Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas6Children's Health, Dallas, Texas.""}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Adix', 'Affiliation': ""Children's Health, Dallas, Texas.""}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Gao', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'McCavit', 'Affiliation': ""Division of Hematology and Oncology, Cook Children's Medical Center, Ft Worth, Texas9Department of Pediatrics, Cook Children's Medical Center, Ft Worth, Texas.""}]",JAMA,['10.1001/jama.2017.6846']
890,31595830,Social anxiety is associated with impaired memory for imagined social events with positive outcomes.,"Cognitive models of social anxiety disorder suggest that memory biases for negative social information contribute to symptoms of social anxiety (SA). However, it remains unclear whether memory biases in SA are related to  social  information, specifically, and if so, whether the valence of such information would moderate memory performance. In the present study, 197 community participants were randomised to imagine themselves as the central character in either 10 social or 10 non-social scenarios. In both conditions, half of the scenarios ended with objectively positive outcomes and half ended with objectively negative outcomes. Results demonstrated that higher trait SA was related to memory performance for social scenarios only, and in particular to poorer memory for social scenarios that ended positively. Thus, the impact of SA on memory performance depended on how social information was framed, with higher SA related to poorer memory for positive social experiences. These context-specific effects contribute to the growing literature on positivity deficits in SA.",2020,"Results demonstrated that higher trait SA was related to memory performance for social scenarios only, and in particular to poorer memory for social scenarios that ended positively.",['197 community participants were randomised to imagine themselves as the central character in either 10 social or 10 non-social scenarios'],[],"['Social anxiety', 'social anxiety (SA', 'higher trait SA']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0007952', 'cui_str': 'Character'}]",[],"[{'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",197.0,0.0157215,"Results demonstrated that higher trait SA was related to memory performance for social scenarios only, and in particular to poorer memory for social scenarios that ended positively.","[{'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Romano', 'Affiliation': 'Department of Psychology and Centre for Mental Health Research and Treatment, University of Waterloo, Waterloo, Canada.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Tran', 'Affiliation': 'Department of Psychology and Centre for Mental Health Research and Treatment, University of Waterloo, Waterloo, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Moscovitch', 'Affiliation': 'Department of Psychology and Centre for Mental Health Research and Treatment, University of Waterloo, Waterloo, Canada.'}]",Cognition & emotion,['10.1080/02699931.2019.1675596']
891,31487415,How and for whom does a positive affect intervention work in fibromyalgia: An analysis of mediators and moderators.,"OBJECTIVES


Psychological interventions designed to enhance positive affect are promising ways to promote adaptive functioning in people with chronic pain. However, few studies have addressed the efficacy of positive affect interventions in chronic pain populations and examined which patients can benefit more from them. The aim of the present study was to identify mediators and moderators of the best possible self intervention (BPS) in fibromyalgia patients.
METHODS


We used data from a previous randomized controlled trial that examined changes in pain interference, depression, self-efficacy and quality of life after the BPS intervention.
RESULTS


Mediation analyses showed that depression mediated changes in pain interference. Positive and negative affect were significant mediators of the change in depression and quality of life. No significant mediators of the change in self-efficacy were found. Baseline levels of quality of life, emotion regulation strategies of negative and positive affect, and rumination moderated the effects of the intervention on depressive symptomatology.
DISCUSSION


In fibromyalgia patients, the effects of the BPS on the outcomes seem to be more related to changes in affect than to changes in future expectations.
SIGNIFICANCE


This study presents evidence about who can benefit from an intervention designed to augment positive affect and promote positive functioning in FMS patients and how these changes occur. It extends previous findings on patient characteristics associated with the response to pain management interventions.",2020,"Baseline levels of quality of life, emotion regulation strategies of negative and positive affect, and rumination moderated the effects of the intervention on depressive symptomatology.
","['people with chronic pain', 'fibromyalgia', 'fibromyalgia patients']",['self intervention (BPS'],"['Baseline levels of quality of life, emotion regulation strategies of negative and positive affect, and rumination', 'depressive symptomatology', 'depression and quality of life', 'pain interference, depression, self-efficacy, and quality of life', 'self-efficacy', 'pain interference']","[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",,0.0971719,"Baseline levels of quality of life, emotion regulation strategies of negative and positive affect, and rumination moderated the effects of the intervention on depressive symptomatology.
","[{'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Molinari', 'Affiliation': 'CIBER of Physiopathology of Obesity and Nutrition CIBERObn, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Miragall', 'Affiliation': 'CIBER of Physiopathology of Obesity and Nutrition CIBERObn, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Enrique', 'Affiliation': 'Trinity College, School of Psychology, Dublin, Ireland.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Botella', 'Affiliation': 'CIBER of Physiopathology of Obesity and Nutrition CIBERObn, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Rosa María', 'Initials': 'RM', 'LastName': 'Baños', 'Affiliation': 'CIBER of Physiopathology of Obesity and Nutrition CIBERObn, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'García-Palacios', 'Affiliation': 'CIBER of Physiopathology of Obesity and Nutrition CIBERObn, Instituto de Salud Carlos III, Madrid, Spain.'}]","European journal of pain (London, England)",['10.1002/ejp.1481']
892,30021886,MHC proteins confer differential sensitivity to CTLA-4 and PD-1 blockade in untreated metastatic melanoma.,"Combination anti-cytotoxic T lymphocyte antigen 4 (CTLA-4) and anti-programmed cell death protein 1 (PD-1) therapy promotes antitumor immunity and provides superior benefit to patients with advanced-stage melanoma compared with either therapy alone. T cell immunity requires recognition of antigens in the context of major histocompatibility complex (MHC) class I and class II proteins by CD8 +  and CD4 +  T cells, respectively. We examined MHC class I and class II protein expression on tumor cells from previously untreated melanoma patients and correlated the results with transcriptional and genomic analyses and with clinical response to anti-CTLA-4, anti-PD-1, or combination therapy. Most (>50% of cells) or complete loss of melanoma MHC class I membrane expression was observed in 78 of 181 cases (43%), was associated with transcriptional repression of  HLA-A ,  HLA-B ,  HLA-C , and  B2M , and predicted primary resistance to anti-CTLA-4, but not anti-PD-1, therapy. Melanoma MHC class II membrane expression on >1% cells was observed in 55 of 181 cases (30%), was associated with interferon-γ (IFN-γ) and IFN-γ-mediated gene signatures, and predicted response to anti-PD-1, but not anti-CTLA-4, therapy. We conclude that primary response to anti-CTLA-4 requires robust melanoma MHC class I expression. In contrast, primary response to anti-PD-1 is associated with preexisting IFN-γ-mediated immune activation that includes tumor-specific MHC class II expression and components of innate immunity when MHC class I is compromised. The benefits of combined checkpoint blockade may be attributable, in part, to distinct requirements for melanoma-specific antigen presentation to initiate antitumor immunity.",2018,"Melanoma MHC class II membrane expression on >1% cells was observed in 55 of 181 cases (30%), was associated with interferon-γ (IFN-γ) and IFN-γ-mediated gene signatures, and predicted response to anti-PD-1, but not anti-CTLA-4, therapy.","['patients with advanced-stage melanoma', 'major histocompatibility complex (MHC) class']","['MHC class', 'Combination anti-cytotoxic T lymphocyte antigen 4 (CTLA-4) and anti-programmed cell death protein 1 (PD-1) therapy']","['I membrane expression', 'complete loss of melanoma MHC class', 'Melanoma MHC class II membrane expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0024518', 'cui_str': 'Histocompatibility Complex'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C0024518', 'cui_str': 'Histocompatibility Complex'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0111208', 'cui_str': 'Cytotoxic T-Lymphocyte-Associated Antigen 4'}, {'cui': 'C0007587', 'cui_str': 'Cell Death'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0025255', 'cui_str': 'Membranes'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0024518', 'cui_str': 'Histocompatibility Complex'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}]",181.0,0.0418277,"Melanoma MHC class II membrane expression on >1% cells was observed in 55 of 181 cases (30%), was associated with interferon-γ (IFN-γ) and IFN-γ-mediated gene signatures, and predicted response to anti-PD-1, but not anti-CTLA-4, therapy.","[{'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Rodig', 'Affiliation': 'Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, MA 02215, USA. srodig@bwh.harvard.edu stephen_hodi@dfci.harvard.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gusenleitner', 'Affiliation': 'Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, MA 02215, USA.'}, {'ForeName': 'Donald G', 'Initials': 'DG', 'LastName': 'Jackson', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ 08540, USA.'}, {'ForeName': 'Evisa', 'Initials': 'E', 'LastName': 'Gjini', 'Affiliation': 'Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, MA 02215, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Giobbie-Hurder', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA 02215, USA.'}, {'ForeName': 'Chelsea', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ 08540, USA.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ 08540, USA.'}, {'ForeName': 'Scott B', 'Initials': 'SB', 'LastName': 'Lovitch', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Boston, MA 20115, USA.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Horak', 'Affiliation': 'Bristol-Myers Squibb, Princeton, NJ 08540, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Weber', 'Affiliation': 'Laura and Isaac Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY 10016, USA.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Weirather', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA 02215, USA.'}, {'ForeName': 'Jedd D', 'Initials': 'JD', 'LastName': 'Wolchok', 'Affiliation': 'Melanoma and Immunotherapeutics Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Postow', 'Affiliation': 'Melanoma and Immunotherapeutics Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Pavlick', 'Affiliation': 'Laura and Isaac Perlmutter Cancer Center, New York University Langone Medical Center, New York, NY 10016, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chesney', 'Affiliation': 'James Graham Brown Cancer Center, University of Louisville, Louisville, KY 40202, USA.'}, {'ForeName': 'F Stephen', 'Initials': 'FS', 'LastName': 'Hodi', 'Affiliation': 'Melanoma Disease Center, Dana-Farber Cancer Institute, Boston, MA 02215, USA. srodig@bwh.harvard.edu stephen_hodi@dfci.harvard.edu.'}]",Science translational medicine,['10.1126/scitranslmed.aar3342']
893,32412097,Comparison of the efficacy of electroconvulsive therapy (ECT) plus agomelatine to ECT plus placebo in treatment-resistant depression.,"OBJECTIVE


Electroconvulsive therapy (ECT) is commonly used to treat patients with treatment-resistant depression. We aimed to investigate whether combining an antidepressant agent with ECT might enhance therapeutic efficacy and prevent early relapse.
METHOD


During the acute ECT phase, patients (N = 97) with treatment-resistant depression were randomized to receive ECT plus agomelatine 50 mg/day (n = 48) or ECT plus placebo (n = 49). Symptom severity measures, including the 17-item Hamilton Depression Rating Scale (HAMD-17) and other scales, functional impairment, quality of life, neuropsychological tests, adverse events and attitudes toward ECT, were assessed regularly. Remission was defined as a HAMD-17 score ≤7. If patients achieved post-ECT remission, they were prescribed agomelatine 50 mg/day and participated in a 12-week follow-up trial. HAMD-17 was rated at 4-week intervals. Relapse was defined as a HAMD-17 score ≥14, or rehospitalization for a psychiatric reason.
RESULTS


The two treatment groups were comparable at (i) baseline variables; (ii) score changes in all symptom measures, functional impairment, quality of life, and neuropsychological tests; (iii) frequency of adverse events and attitudes toward ECT; and (iv) post-ECT response/remission rates. There were no statistically significant differences following ECT in relapse rates and time to relapse between these two groups.
CONCLUSION


Adding agomelatine to ECT yielded comparable response/remission rates to ECT without agomelatine in the acute ECT phase. Starting agomelatine in combination with ECT did not seem to be more efficacious in preventing relapse than starting agomelatine after the acute ECT course. More research is needed to guide clinical recommendations.",2020,Starting agomelatine in combination with ECT did not seem to be more efficacious in preventing relapse than starting agomelatine after the acute ECT course.,"['patients with treatment-resistant depression', 'patients (N = 97) with treatment-resistant depression']","['ECT', 'ECT plus agomelatine to ECT plus placebo', 'ECT plus agomelatine', 'Electroconvulsive therapy (ECT', 'ECT plus placebo']","['17-item Hamilton Depression Rating Scale (HAMD-17) and other scales, functional impairment, quality of life, neuropsychological tests, adverse events and attitudes toward ECT', 'response/remission rates', 'Remission', 'Relapse', 'symptom measures, functional impairment, quality of life, and neuropsychological tests, 3) frequency of adverse events and attitudes toward ECT, and 4) post-ECT response/remission rates', 'relapse rates and time to relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0971637', 'cui_str': 'agomelatine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",97.0,0.124056,Starting agomelatine in combination with ECT did not seem to be more efficacious in preventing relapse than starting agomelatine after the acute ECT course.,"[{'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Lin', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'W-C', 'Initials': 'WC', 'LastName': 'Yang', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'C-C', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'W-R', 'Initials': 'WR', 'LastName': 'Cai', 'Affiliation': 'Kaohsiung Municipal Kai-Syuan Psychiatric Hospital, Kaohsiung, Taiwan.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13183']
894,31599810,Reduction of Postoperative Wound Infections by Antiseptica (RECIPE)?: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate whether intraoperative subcutaneous wound irrigation with 0.04% polyhexanide can reduce surgical site infection (SSI) in elective laparotomies compared to saline.
BACKGROUND


SSI is a common complication after gastrointestinal surgery. To date, there is a lack of evidence whether subcutaneous wound irrigation is beneficial in terms of reduction of SSI.
METHODS


The RECIPE trial was an investigator initiated single-center, single-blind prospective, randomized controlled trial with 2 parallel treatment groups, comparing wound irrigation with 0.9% saline to antiseptic 0.04% polyhexanide solution in elective laparotomies. Primary endpoint was the rate of SSI within 30 days postoperatively according to Centers for Disease Control and Prevention criteria.
RESULTS


Between February 02, 2015, and May 23, 2018, 456 patients were randomly assigned to saline (n = 228) or polyhexanide (n = 228). Final cohort for analysis comprised 393 patients (202 in the saline and 191 in the polyhexanide group). Overall rate of SSI was 28.2%, n = 111. Simple analysis with cross tabulation revealed that significantly fewer SSIs occurred in the polyhexanide group: n = 70 (34.7%) versus n = 41 (21.5%); P = 0.004. In a multiple logistic regression model the factor wound irrigation with polyhexanide [odds ratio (OR) 0.44; 95% confidence interval (CI) 0.27-0.72; P = 0.001) was associated with risk reduction of SSI. Preoperative anemia (OR 2.08; 95% CI 1.27-3.40; P = 0.004) and more than 5 prior abdominal operations compared to none (OR 8.51; 95% CI 2.57-28.21; P < 0.001) were associated with SSI.
CONCLUSIONS


Intraoperative subcutaneous wound irrigation with antiseptic 0.04% polyhexanide solution is effective in reducing SSI after elective laparotomies.",2020,"Preoperative anemia (OR 2.08; 95% CI 1.27-3.40; P = 0.004) and more than 5 prior abdominal operations compared to none (OR 8.51; 95% CI 2.57-28.21; P < 0.001) were associated with SSI.
","['Between February 02, 2015, and May 23, 2018, 456 patients', '393 patients (202 in the saline and 191 in the polyhexanide group']","['Antiseptica (RECIPE', 'intraoperative subcutaneous wound irrigation with 0.04% polyhexanide', 'saline', 'antiseptic 0.04% polyhexanide solution', 'wound irrigation with 0.9% saline to antiseptic 0.04% polyhexanide solution', 'polyhexanide']","['Overall rate of SSI', 'SSIs', 'rate of SSI within 30 days postoperatively according to Centers for Disease Control and Prevention criteria', 'surgical site infection (SSI', 'risk reduction of SSI', 'Preoperative anemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0376892', 'cui_str': 'polihexanide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0600194', 'cui_str': 'Recipes'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0150410', 'cui_str': 'Irrigation of wound (procedure)'}, {'cui': 'C4517407', 'cui_str': 'Zero point zero four'}, {'cui': 'C0376892', 'cui_str': 'polihexanide'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C3540796', 'cui_str': 'Antiseptic throat preparations'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",456.0,0.287261,"Preoperative anemia (OR 2.08; 95% CI 1.27-3.40; P = 0.004) and more than 5 prior abdominal operations compared to none (OR 8.51; 95% CI 2.57-28.21; P < 0.001) were associated with SSI.
","[{'ForeName': 'Rahel M', 'Initials': 'RM', 'LastName': 'Strobel', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Marja', 'Initials': 'M', 'LastName': 'Leonhardt', 'Affiliation': 'Innlandet Hospital Trust, Norwegian National Advisory Unit on Concurrent Substance Abuse and Mental Health Disorders, Brumunddal, Norway.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Krochmann', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Neumann', 'Affiliation': 'Institute of Biometry and Clinical Epidemiology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Speichinger', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hartmann', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Lucas D', 'Initials': 'LD', 'LastName': 'Lee', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Beyer', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Severin', 'Initials': 'S', 'LastName': 'Daum', 'Affiliation': 'Department of Gastroenterology, Rheumatology and Infectious Diseases, Charité Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'Kreis', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'Lauscher', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm, Berlin, Germany.'}]",Annals of surgery,['10.1097/SLA.0000000000003645']
895,28710110,Impact of a patient-tailored complementary/integrative medicine programme on disturbed sleep quality among patients undergoing chemotherapy.,"OBJECTIVES


The present study examined the impact of a patient-tailored complementary/integrative medicine (CIM) programme on sleep quality in patients undergoing chemotherapy for breast and gynaecological cancer.
METHODS


Study participants received standard supportive care, with or without weekly CIM treatments. Disturbed sleep quality was defined as a score of ≥4 on the Edmonton Symptom Assessment Scale (ESAS) or a score of ≥3 on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Adherence to integrative care was defined as attending ≥4 CIM treatments, with ≤30 days between each session.
RESULTS


Of 388 eligible patients, 264 (68%) reported disturbed sleep quality. Baseline-to-follow up assessment (at 6 weeks) was optimal for 104 patients in the treatment group and for 76 controls, with 75 of treated patients found to be adherent to the CIM intervention. Sleep-related ESAS scores improved more significantly in treated patients (p=0.008), as did sleep-related concerns on EORTC (treatment group, p=0.026).
CONCLUSIONS


A patient-tailored CIM programme may improve sleep quality and related concerns among patients with breast and gynaecological cancer undergoing chemotherapy. Further research is needed to better understand the impact of CIM on sleep quality in this patient population.
TRIAL REGISTRATION NUMBER


NCT01860365.",2020,"Sleep-related ESAS scores improved more significantly in treated patients (p=0.008), as did sleep-related concerns on EORTC (treatment group, p=0.026).
","['patients undergoing chemotherapy', 'patients with breast and gynaecological cancer undergoing chemotherapy', 'patients undergoing chemotherapy for breast and gynaecological cancer', '388 eligible patients']","['standard supportive care, with or without weekly CIM treatments', 'patient-tailored complementary/integrative medicine programme', 'patient-tailored complementary/integrative medicine (CIM) programme']","['Edmonton Symptom Assessment Scale (ESAS) or a score of ≥3 on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30', 'Disturbed sleep quality', 'sleep quality', 'disturbed sleep quality', 'Sleep-related ESAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2350258', 'cui_str': 'Integrative Medicine'}]","[{'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451149', 'cui_str': 'EORTC - Quality of life questionnaire'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",388.0,0.0430676,"Sleep-related ESAS scores improved more significantly in treated patients (p=0.008), as did sleep-related concerns on EORTC (treatment group, p=0.026).
","[{'ForeName': 'Hilit', 'Initials': 'H', 'LastName': 'Kerner', 'Affiliation': 'Integrative Oncology Program, The Oncology Service and Lin Medical Center, Clalit Health Services, Haifa, Israel.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Samuels', 'Affiliation': 'Tal Center for Integrative Oncology, Institute of Oncology, Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Shlomi', 'Initials': 'S', 'LastName': 'Ben Moshe', 'Affiliation': 'Sleep Laboratory and Clinics, Clalit Health Services, Haifa and Western Galilee and Carmel Medical Center, Kiryat Bialik, Israel.'}, {'ForeName': 'Ilanit Shalom', 'Initials': 'IS', 'LastName': 'Sharabi', 'Affiliation': 'Integrative Oncology Program, The Oncology Service and Lin Medical Center, Clalit Health Services, Haifa, Israel.'}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Ben-Arye', 'Affiliation': 'Integrative Oncology Program, The Oncology Service and Lin Medical Center, Clalit Health Services, Haifa, Israel.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2017-001351']
896,31586420,"Secukinumab provides sustained low rates of radiographic progression in psoriatic arthritis: 52-week results from a phase 3 study, FUTURE 5.","OBJECTIVE


To evaluate the effect of secukinumab on radiographic progression through 52 weeks in patients with PsA from the FUTURE 5 study.
METHODS


Patients with active PsA, stratified by prior anti-TNF use (naïve or inadequate response), were randomized to s.c. secukinumab 300 mg load (300 mg), 150 mg load (150 mg), 150 mg no load regimens or placebo at baseline, at weeks 1, 2 and 3 and every 4 weeks starting at week 4. Radiographic progression was assessed by change in van der Heijde-modified total Sharp score (vdH-mTSS; mean of two readers). Statistical analysis used a linear mixed-effects model (random slope) at weeks 24 and 52, and observed data at week 52. Assessments at week 52 included additional efficacy endpoints (non-responders imputation and mixed-effects models for repeated measures) and safety.
RESULTS


The majority (86.6%) of patients completed 52 weeks of treatment. The proportion of patients with no radiographic progression (change from baseline in vdH-mTSS ⩽0.5) was 91.8, 85.2 and 87.2% in 300, 150 and 150 mg no load groups, respectively, at week 52. The change in vdH-mTSS from baseline to week 52 using random slope [mean change (s.e.)] was -0.18 (0.17), 0.11 (0.18) and -0.20 (0.18) in 300, 150 and 150 mg no load groups, respectively; the corresponding observed data [mean change (s.d.)] was -0.09 (1.02), 0.13 (1.39) and 0.21 (1.15). Clinical efficacy endpoints were sustained, and no new or unexpected safety signals were reported through 52 weeks.
CONCLUSION


Secukinumab 300 and 150 mg with or without s.c. loading regimen provided sustained low rates of radiographic progression through 52 weeks of treatment.
TRIAL REGISTRATION


ClinicalTrials.gov, http://clinicaltrials.gov, NCT02404350.",2020,Radiographic progression was assessed by change in van der Heijde-modified total Sharp score (vdH-mTSS; mean of two readers).,"['Patients with active PsA, stratified by prior anti-TNF use (naïve or inadequate response', 'psoriatic arthritis', 'patients with PsA from the FUTURE 5 study']","['placebo', 'Secukinumab', 'secukinumab 300 mg load', 'secukinumab']","['radiographic progression', 'safety', 'Radiographic progression', 'change in vdH-mTSS', 'proportion of patients with no radiographic progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.0869609,Radiographic progression was assessed by change in van der Heijde-modified total Sharp score (vdH-mTSS; mean of two readers).,"[{'ForeName': 'Désirée', 'Initials': 'D', 'LastName': 'van der Heijde', 'Affiliation': 'Department of Rheumatology, Leiden University Medical Centre, Leiden, The Netherlands.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St Joseph Health and University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Robert B M', 'Initials': 'RBM', 'LastName': 'Landewé', 'Affiliation': 'Department of Rheumatology, University of Amsterdam and Atrium Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Proton', 'Initials': 'P', 'LastName': 'Rahman', 'Affiliation': 'Faculty of Medicine, Memorial University, St Johns, Newfoundland and Labrador, Canada.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Tahir', 'Affiliation': 'Rheumatology, Whipps Cross Hospital, London, UK.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Singhal', 'Affiliation': 'Southwest Rheumatology, Dallas, TX, USA.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Boettcher', 'Affiliation': 'Rheumazentrum Favoriten, Vienna, Austria.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Navarra', 'Affiliation': ""St Luke's Medical Center, University of Santo Tomas Hospital, Manila, Philippines.""}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Ligozio', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Readie', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Shephard', 'Initials': 'S', 'LastName': 'Mpofu', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Luminita', 'Initials': 'L', 'LastName': 'Pricop', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez420']
897,31603245,Oral hygiene revisited. The clinical effect of a prolonged oral hygiene phase prior to periodontal therapy in periodontitis patients. A randomized clinical study.,"AIM


The aim of the present study was to investigate the effect of a 3-month strict oral hygiene phase on key parameters of periodontitis: plaque, bleeding on probing (BOP) and probing pocket depth (PPD).
MATERIALS AND METHODS


Forty-four patients with severe periodontal disease were randomly allocated to a test or a control group. The test group completed a 3-month strict oral hygiene phase. The control group did not receive any instructions or motivation on oral hygiene until after the 3-month period. Plaque, BOP and PPDs were registered on four sites of each tooth at baseline and after 3 months in both groups, as well as after the postponed hygiene phase in the control group.
RESULTS


A statistically significant and profound reduction in plaque, BOP and PPD was observed after the 3 months in the test group. No change to the better occurred in the control group.
CONCLUSION


A 3-month strict oral hygiene phase in patients referred for periodontal therapy reduced plaque, BOP and pocket depth to such an extent that it could affect therapy planning.",2020,"RESULTS


A statistically significant and profound reduction of plaque, bleeding on probing and probing pocket depth was observed after the three months in the test group.","['periodontitis patients', 'Forty-four patients with severe periodontal disease']",[],"['periodontitis: plaque, bleeding on probing and probing pocket depth', 'plaque, bleeding on probing and probing pocket depth', 'Plaque, bleeding on probing and probing pocket depths']","[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0031090', 'cui_str': 'Parodontosis'}]",[],"[{'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}]",44.0,0.0286475,"RESULTS


A statistically significant and profound reduction of plaque, bleeding on probing and probing pocket depth was observed after the three months in the test group.","[{'ForeName': 'Hans R', 'Initials': 'HR', 'LastName': 'Preus', 'Affiliation': 'Department of Periodontology, Institute of Clinical Odontology, Faculty of Dentistry, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Qamar', 'Initials': 'Q', 'LastName': 'Al-Lami', 'Affiliation': 'Department of Periodontology, Institute of Clinical Odontology, Faculty of Dentistry, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Baelum', 'Affiliation': 'Department of Dentistry Health, Aarhus University, Aarhus, Denmark.'}]",Journal of clinical periodontology,['10.1111/jcpe.13207']
898,29087256,"Technology Use, Preferences, and Capacity in Injured Patients at Risk for Posttraumatic Stress Disorder.","OBJECTIVE


This investigation comprehensively assessed the technology use, preferences, and capacity of diverse injured trauma survivors with posttraumatic stress disorder (PTSD) symptoms.
METHOD


A total of 121 patients participating in a randomized clinical trial (RCT) of stepped collaborative care targeting PTSD symptoms were administered baseline one-, three-, and six-month interviews that assessed technology use. Longitudinal data about the instability of patient cell phone ownership and phone numbers were collected from follow-up interviews. PTSD symptoms were also assessed over the course of the six months after injury. Regression analyses explored the associations between cell phone instability and PTSD symptoms.
RESULTS


At baseline, 71.9% (n = 87) of patients reported current cell phone ownership, and over half (58.2%, n = 46) of these patients possessed basic cell phones. Only 19.0% (n = 23) of patients had no change in cell phone number or physical phone over the course of the six months postinjury. In regression models that adjusted for relevant clinical and demographic characteristics, cell phone instability was associated with higher six-month postinjury PTSD symptom levels (p < 0.001).
CONCLUSIONS


Diverse injured patients at risk for the development of PTSD have unique technology use patterns, including high rates of cell phone instability. These observations should be strongly considered when developing technology-supported interventions for injured patients with PTSD.",2017,Only 19.0% (n = 23) of patients had no change in cell phone number or physical phone over the course of the six months postinjury.,"['injured patients with PTSD', 'diverse injured trauma survivors with posttraumatic stress disorder (PTSD) symptoms', '121 patients participating in a randomized clinical trial (RCT) of stepped collaborative care targeting PTSD symptoms', 'Injured Patients at Risk for Posttraumatic Stress Disorder']",[],"['PTSD symptoms', 'cell phone number or physical phone']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]",[],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1136359', 'cui_str': 'Cell Phone'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}]",121.0,0.0370737,Only 19.0% (n = 23) of patients had no change in cell phone number or physical phone over the course of the six months postinjury.,"[{'ForeName': 'Cory M', 'Initials': 'CM', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Erik G', 'Initials': 'EG', 'LastName': 'Van Eaton', 'Affiliation': ''}, {'ForeName': 'Joan E', 'Initials': 'JE', 'LastName': 'Russo', 'Affiliation': ''}, {'ForeName': 'Victoria C', 'Initials': 'VC', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Jurkovich', 'Affiliation': ''}, {'ForeName': 'Doyanne A', 'Initials': 'DA', 'LastName': 'Darnell', 'Affiliation': ''}, {'ForeName': 'Lauren K', 'Initials': 'LK', 'LastName': 'Whiteside', 'Affiliation': ''}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Lea E', 'Initials': 'LE', 'LastName': 'Parker', 'Affiliation': ''}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Payne', 'Affiliation': ''}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Mooney', 'Affiliation': ''}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Bush', 'Affiliation': ''}, {'ForeName': 'Douglas F', 'Initials': 'DF', 'LastName': 'Zatzick', 'Affiliation': ''}]",Psychiatry,['10.1080/00332747.2016.1271162']
899,30473262,Influencing Mindsets and Motivation in Procedural Skills Learning: Two Randomized Studies.,"OBJECTIVES


An incremental (growth) theory of intelligence (mindset), compared with an entity (fixed) mindset, has been associated with improved motivation and performance. Interventions to induce incremental beliefs have improved performance on non-surgical motor tasks. We sought to evaluate the impact of 2 brief interventions to induce incremental beliefs in the context of learning a surgical task.
DESIGN


Two randomized experiments.
PARTICIPANTS AND SETTING


Secondary school students participating in medical simulation-based training activities at an academic medical center.
INTERVENTIONS


We created 4 instructional messages intended to influence mindsets (two 60-second videos in Study 1, 2 fabricated ""journal articles"" in Study 2). In each study, one message emphasized that ability improves with practice (incremental); the other emphasized that ability is fixed (entity). After reviewing their randomly-assigned message, participants completed a laparoscopic cutting task as many times as they desired. Measurements included performance (product quality, self-reported task, and completion time), task persistence (repetitions), and entity beliefs.
RESULTS


Two hundred and three students completed Study 1. Postevent entity beliefs (1 = lowest, 6 = highest) were similar between groups (incremental, 2.0vs entity, 2.0; p = 0.78). Contrary to hypothesis, the incremental video group demonstrated slower time (276vs 191 seconds; p < 0.0001), lower product quality (7.2vs 3.8mm deviation; p < 0.0001), and fewer task repetitions (1.4vs 1.8; p = 0.02). In Study 2, 113 participants provided outcomes related to mindset beliefs, but only 14 provided usable performance outcomes. Postevent entity beliefs were lower in the incremental article group (1.7vs 2.4; p < 0.0001). Task time (507vs 585 seconds; p = 0.40) and quality (7.1vs 7.5mm deviation; p = 0.85) were similar between groups.
CONCLUSIONS


Brief motivational interventions can influence procedural performance and motivation. We need to better understand motivation and other affective influences on procedural skills learning. Mindset theory shows promise in this regard.",2019,"Contrary to hypothesis, the incremental video group demonstrated slower time (276vs 191 seconds; p < 0.0001), lower product quality (7.2vs 3.8mm deviation; p < 0.0001), and fewer task repetitions (1.4vs 1.8; p = 0.02).","['Two hundred and three students completed Study 1', 'Secondary school students participating in medical simulation-based training activities at an academic medical center', '113 participants']","['Brief motivational interventions', 'laparoscopic cutting task']","['Task time', 'task repetitions', 'lower product quality', 'Postevent entity beliefs', 'quality', 'performance (product quality, self-reported task, and completion time), task persistence (repetitions), and entity beliefs']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0040606', 'cui_str': 'Training Activities'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0000925', 'cui_str': 'Incised wound - morphology (morphologic abnormality)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0546816', 'cui_str': 'Persistence (finding)'}]",4.0,0.145836,"Contrary to hypothesis, the incremental video group demonstrated slower time (276vs 191 seconds; p < 0.0001), lower product quality (7.2vs 3.8mm deviation; p < 0.0001), and fewer task repetitions (1.4vs 1.8; p = 0.02).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Cook', 'Affiliation': 'Mayo Clinic Multidisciplinary Simulation Center, Mayo Clinic College of Medicine and Science, Rochester, Minnesota; Division of General Internal Medicine, Mayo Clinic, Rochester, Minnesota. Electronic address: cook.david33@mayo.edu.'}, {'ForeName': 'Becca L', 'Initials': 'BL', 'LastName': 'Gas', 'Affiliation': 'Center for Clinical and Translational Sciences, Mayo Clinic, Rochester, Minnesota; Department of Subspecialty General Surgery, Mayo Clinic, Rochester, Minnesota. Electronic address: gas.becca@mayo.edu.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Farley', 'Affiliation': 'Department of Subspecialty General Surgery, Mayo Clinic, Rochester, Minnesota. Electronic address: farley.david@mayo.edu.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lineberry', 'Affiliation': 'Zamierowski Institute for Experiential Learning, University of Kansas Medical Center and Health System, Kansas City, Kansas. Electronic address: mlineberry@kumc.edu.'}, {'ForeName': 'Nimesh D', 'Initials': 'ND', 'LastName': 'Naik', 'Affiliation': 'Department of Subspecialty General Surgery, Mayo Clinic, Rochester, Minnesota. Electronic address: naik.nimesh@mayo.edu.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Cardenas Lara', 'Affiliation': 'Department of Subspecialty General Surgery, Mayo Clinic, Rochester, Minnesota. Electronic address: lara.francisco@mayo.edu.'}, {'ForeName': 'Anthony R', 'Initials': 'AR', 'LastName': 'Artino', 'Affiliation': 'Department of Medicine, F. Edward Hébert School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland. Electronic address: anthony.artino@usuhs.edu.'}]",Journal of surgical education,['10.1016/j.jsurg.2018.09.018']
900,31605198,Efficacy of an intermittent energy restriction diet in a primary care setting.,"PURPOSE


Intermittent energy restriction (IER) is a popular weight loss (WL) strategy; however, its efficacy in clinical practice remains unknown. The present study compared the effects of IER compared to continuous energy restriction (CER) on WL and cardiometabolic risk factors in primary care.
METHODS


A (self-selected) cohort study was conducted at the Rotherham Institute for Obesity (RIO), a primary care-based weight management service. 197(24% male) obese patients volunteered to participate and selected their diet group. IER participants (n = 99) consumed ~ 2600 kJ for two days/week. CER participants (n = 98) restricted their diet by ~ 2100 kJ/day below estimated requirements. Both interventions were delivered alongside RIO standard care. Changes in anthropometry and cardiometabolic disease risk markers (fasting biochemistry and blood pressure) were assessed after a 6-month intervention period and then participants were followed up again 6 months later (month 12).
RESULTS


27 IER patients (27%) and 39 CER patients (40%) completed the 6-month weight loss phase. Among completers, mean (SEM) WL was greater in the IER group at 6 months (5.4 ± 1.1% versus 2.8 ± 0.6%; p = 0.01), as were reductions in fat mass (p < 0.001) and improvements in systolic blood pressure (p < 0.001). Fasting insulin (p = 0.873) and diastolic blood pressure (p = 0.701) were reduced similarly in both groups. However, in the IER group, changes in anthropometry and blood pressure in the IER group had reverted to baseline by 12-month follow-up, whilst the CER group maintained weight loss but showed an increase in blood pressure.
CONCLUSIONS


Among completers, IER resulted in superior short-term changes in anthropometry and some cardiometabolic risk factors. However, rates of attrition and weight regain were higher compared with standard care, providing important insights in the implementations of IER within a ""real-life"" NHS setting.
TRIAL REGISTRATION NUMBER


ISRCTN31465600.",2020,"Among completers, IER resulted in superior short-term changes in anthropometry and some cardiometabolic risk factors.","['197(24% male) obese patients volunteered to participate and selected their diet group', 'A (self-selected) cohort study was conducted at the Rotherham Institute for Obesity (RIO), a primary care-based weight management service', 'IER participants (n\u2009=\u200999) consumed\u2009']","['intermittent energy restriction diet', 'continuous energy restriction (CER', 'IER', 'Intermittent energy restriction (IER', 'CER']","['IER resulted in superior short-term changes in anthropometry and some cardiometabolic risk factors', 'systolic blood pressure', 'fat mass', 'blood pressure', 'diastolic blood pressure', 'rates of attrition and weight regain', 'anthropometry and cardiometabolic disease risk markers (fasting biochemistry and blood pressure', 'mean (SEM) WL', 'weight loss', 'anthropometry and blood pressure', 'Fasting insulin', 'WL and cardiometabolic risk factors', '6-month weight loss phase']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0237504', 'cui_str': 'CER (body structure)'}]","[{'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]",,0.024206,"Among completers, IER resulted in superior short-term changes in anthropometry and some cardiometabolic risk factors.","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Antoni', 'Affiliation': 'Nutritional Sciences, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Johnston', 'Affiliation': 'Lighterlife UK Ltd, Cavendish House, Parkway, Harlow Business Park, Essex, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Steele', 'Affiliation': 'Clifton Medical Centre, The Health Village, Rotherham Institute for Obesity, Doncaster Gate, Rotherham, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Carter', 'Affiliation': 'Clifton Medical Centre, The Health Village, Rotherham Institute for Obesity, Doncaster Gate, Rotherham, UK.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Robertson', 'Affiliation': 'Nutritional Sciences, Faculty of Health and Medical Sciences, University of Surrey, Guildford, UK.'}, {'ForeName': 'M S', 'Initials': 'MS', 'LastName': 'Capehorn', 'Affiliation': 'Clifton Medical Centre, The Health Village, Rotherham Institute for Obesity, Doncaster Gate, Rotherham, UK. mcapehorn@yahoo.co.uk.'}]",European journal of nutrition,['10.1007/s00394-019-02098-y']
901,31600472,Learning While Playing: A Randomized Trial of Serious Games as a Tool for Word Mastery.,"Objectives The aim of this study was to determine whether college students build their vocabularies by playing a serious game that incorporates principles of learning and memory. Design This study used a single-site, prospective, randomized trial with 2 branches: immediate and delayed treatment. Outcome measures were obtained after a 1-month intervention and, for the immediate group only, after a 1-month retention interval. Setting College students from the University of Iowa were recruited via mass e-mail. The intervention took place in the participants' homes; the testing took place in a university laboratory. Participants Forty undergraduates (32 women, 8 men) who planned to take the Graduate Record Examinations (GRE; Educational Testing Service, 2018) within the year following the treatment participated in the study. Participants were allocated to 1 of the 2 treatment branches via biased coin randomization. Intervention The treatment consisted of vocabulary training on Vocabulary.com for a minimum of 20 min (dose) 4 times per week (frequency) for 4 weeks (treatment duration), for a total cumulative treatment intensity of 320 min. Outcome Measures The prespecified primary outcome measures of word learning were the number of words mastered during Vocabulary.com play and the percentage of mastered words accurately defined. The depth of information included in the definitions was a secondary outcome. The prespecified primary outcome measure of functional impact was change in the verbal GRE practice test scores from pre- to posttreatment. The examiners scoring the definitions were blind to treatment assignment. All other outcomes were measured automatically by the relevant computer program so blinding was moot. Results The participants averaged 5.33 hr of play during the treatment interval and mastered 124 words. Amount of play and mastery were highly correlated. Accuracy of definitions was 55% or 59% (depending on treatment branch) after treatment and 55% 1 month later, an insignificant decline. The game itself did not result in GRE gains, but participants who mastered more words per minute of play had higher GRE scores than other participants. Conclusion Vocabulary.com, an evidence-based game, showed promise as a way to build vocabulary knowledge, but at the intensity of treatment provided, it did not result in gains in high-stakes test performance. Trial Registration This trial was not preregistered. Supplemental Material https://doi.org/10.23641/asha.9936374.",2019,"Accuracy of definitions was 55% or 59% (depending on treatment branch) after treatment and 55% 1 month later, an insignificant decline.","['Setting College students from the University of Iowa were recruited via mass e-mail', 'college students', 'Participants Forty undergraduates (32 women, 8 men) who planned to take the Graduate Record Examinations (GRE; Educational Testing Service, 2018) within the year following the treatment participated in the study']","['Intervention', 'Supplemental Material https://doi.org/10.23641/asha.9936374', 'vocabulary training']","['functional impact', 'verbal GRE practice test scores', 'word learning were the number of words mastered during Vocabulary.com play and the percentage of mastered words accurately defined', 'GRE scores', 'GRE gains']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0018122', 'cui_str': 'Graduate Records Examination'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0444649', 'cui_str': 'Master (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}]",32.0,0.146163,"Accuracy of definitions was 55% or 59% (depending on treatment branch) after treatment and 55% 1 month later, an insignificant decline.","[{'ForeName': 'Karla K', 'Initials': 'KK', 'LastName': 'McGregor', 'Affiliation': 'Department of Communication Sciences and Disorders, The University of Iowa, Iowa City.'}, {'ForeName': 'Brooke A', 'Initials': 'BA', 'LastName': 'Marshall', 'Affiliation': 'Department of Communication Sciences and Disorders, The University of Iowa, Iowa City.'}, {'ForeName': 'Samantha K', 'Initials': 'SK', 'LastName': 'Julian', 'Affiliation': 'Department of Communication Sciences and Disorders, The University of Iowa, Iowa City.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Oleson', 'Affiliation': 'Department of Biostatistics, The University of Iowa, Iowa City.'}]","Language, speech, and hearing services in schools",['10.1044/2019_LSHSS-VOIA-18-0121']
902,31433893,"The impact of ultrasound-guided continuous serratus anterior plane block versus intravenous patient-controlled analgesia on the incidence and severity of post-thoracotomy pain syndrome: A randomized, controlled study.","OBJECTIVE


The aim of this randomized controlled trial was to evaluate U/S guided serratus anterior plane catheter block (SAPB) versus patient-controlled analgesia (PCA) on the emergence of post-thoracotomy pain syndrome (PTPS) after thoracotomies for thoracic tumours.
METHODS


This trial included 89 patients with chest malignancies, scheduled for thoracotomy were randomly allocated into two groups: Group A ""PCA-group N=44"" receiving patient-controlled analgesia and group B ""SAPB group N=45"" where analgesia was provided by SAPB. The primary outcome measure was the assessment for the possible emergence of PTPS at 12 weeks. The secondary outcome measures were pain relief measured using visual analog scale (VAS) score, Quality of life was assessed using Flanagan Quality of Life Scale (QOLS) and Activity level was assessed using Barthel Activity of daily living (ADL) score.
RESULTS


At week 8, PTPS incidence was significantly (p = .037) higher in the PCA group (45%) than in the SAPB group (24%) with a relative risk of 1.38 and 95% CI (1.01-1.9) while the incidence of PTPS at week 12 was significantly (p = .035) higher in the PCA group (43%) than in the SAPB group (22%) with a relative risk of 2.38 and 95% CI (1.23-4.57). The need for pain therapy in PTPS patients was significantly lower in the SAPB group (17.7%) than the PCA group (38.6%) (p = .028) at week 12. Pain intensity: VAS-R and VAS-D (pain scores at rest and with activity, respectively) was comparable (p > .05) between both groups at 6, 12, 18 and 24 hr, however VAS was significantly higher in the PCA group at week 8 (p = .046) and week 12 (p = .032) . Both groups were comparable regarding ADL and QOL scores (p > .05).
CONCLUSION


Serratus anterior plane block is assumed to be a good alternative for post-thoracotomy analgesia following thoracotomies. The current work hypothesized that SAPB for a week postoperatively, may reduce the emergence of PTPS and may reduce the demand for pain therapy in those patients.
SIGNIFICANCE STATEMENT


The current work hypothesized that SAPB for a week postoperatively, is a good loco-regional alternative for post-thoracotomy analgesia following thoracotomies for chest malignancies, it may reduce the emergence of PTPS and the demand for pain therapy in these patients.",2020,The need for pain therapy in PTPS patients was significantly lower in the SAPB group (17.7%) than PCA group (38.6%) (P= 0.028) at week 12.,"['89 patients with chest malignancies, scheduled for thoracotomy', 'post-thoracotomy pain syndrome', 'post-thoracotomy pain syndrome (PTPS) after thoracotomies for thoracic tumors']","['ultrasound-guided continuous serratus anterior plane block versus intravenous patient-controlled analgesia', 'PCA', 'U/S guided serratus anterior plane catheter block (SAPB) versus patient-controlled analgesia (PCA', 'PCA-group N=44"" receiving patient-controlled analgesia and group B ""SAPB group N=45"" where analgesia was provided by serratus anterior plane catheter block']","['ADL and QOL scores', 'PTPS incidence', 'incidence of PTPS', 'need for pain therapy', 'VAS', 'Pain intensity: VAS-R and VAS-D (pain scores', 'pain relief measured by visual analog scale (VAS) score, Quality of life was assessed by Flanagan Quality of Life Scale (QOLS) and Activity level', 'Barthel Activity of daily living (ADL) score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C0406844', 'cui_str': 'Post-thoracotomy pain syndrome (finding)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0284927', 'cui_str': 'PTPS'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0034380'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale (assessment scale)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",89.0,0.138435,The need for pain therapy in PTPS patients was significantly lower in the SAPB group (17.7%) than PCA group (38.6%) (P= 0.028) at week 12.,"[{'ForeName': 'Raafat M', 'Initials': 'RM', 'LastName': 'Reyad', 'Affiliation': 'Department of Anesthesia and Pain Medicine, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ehab H', 'Initials': 'EH', 'LastName': 'Shaker', 'Affiliation': 'Department of Anesthesia and Pain Medicine, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Hossam Z', 'Initials': 'HZ', 'LastName': 'Ghobrial', 'Affiliation': 'Department of Anesthesia and Pain Medicine, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Dina N', 'Initials': 'DN', 'LastName': 'Abbas', 'Affiliation': 'Department of Anesthesia and Pain Medicine, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ehab M', 'Initials': 'EM', 'LastName': 'Reyad', 'Affiliation': 'Department of Clinical Pathology, National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.'}, {'ForeName': 'Abd Alrahman M', 'Initials': 'AAM', 'LastName': 'Abd Alrahman', 'Affiliation': 'Department of Surgical Oncology, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Al-Demery', 'Affiliation': 'Department of Surgical Oncology, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Emad R H', 'Initials': 'ERH', 'LastName': 'Issak', 'Affiliation': 'Neuropsychiatry Researcher, ClinAmygate, Cairo, Egypt.'}]","European journal of pain (London, England)",['10.1002/ejp.1473']
903,28974486,Combined Dietary Nitrate and Exercise Intervention in Peripheral Artery Disease: Protocol Rationale and Design.,"BACKGROUND


Peripheral artery disease (PAD) is caused by atherosclerotic occlusions in the legs. It affects approximately 8-12 million people in the United States alone, one-third of whom suffer from intermittent claudication (IC), defined as ischemic leg pain that occurs with walking and improves with rest. Patients with IC suffer a markedly impaired quality of life and a high perception of disability. Improving pain-free walking time is a primary goal of rehabilitation in this population.
OBJECTIVE


The nitric oxide (NO)-PAD trial is designed to compare the effects that 12 weeks of supervised exercise training, in combination with a high inorganic nitrate-content (beetroot [BR] juice) beverage or placebo (PL) beverage, has on clinical outcomes of exercise and functional capacity in two groups of PAD+IC patients: exercise training plus beetroot (EX+BR) and exercise training plus placebo (EX+PL). The primary aims of this randomized controlled, double-blind pilot study are to determine group differences following 12 weeks of EX+BR versus EX+PL in the changes for (1) exercise capacity: pain-free walking time (claudication onset time, COT), peak walk time (PWT), and maximal exercise capacity (peak oxygen uptake, VO 2peak ) during a maximal-graded cardiopulmonary exercise test (max CPX) and (2) functional capacity: 6-minute walk (6MW) distance. The secondary aims will provide mechanistic insights into the exercise outcome measures and will include (1) gastrocnemius muscle oxygenation during exercise via near-infrared spectroscopy (NIRS); (2) gastrocnemius muscle angiogenesis: capillaries per unit area and per muscle fiber, and relative fraction of type I, IIa, IIb, and IId/x fibers; and (3) vascular health/function via brachial artery flow-mediated dilation, lower-limb blood flow via plethysmography, and pulse wave velocity and reflection.
METHODS


A total of 30 subjects between 40 and 80 years of age with PAD who are limited by IC will undergo exercise training 3 days per week for 12 weeks (ie, 36 sessions). They will be randomized to either the EX+BR or EX+PL group where participants will consume a beverage high in inorganic nitrate (4.2 mmol) or a low-nitrate placebo, respectively, 3 hours prior to each training session.
RESULTS


Data collection from this study has been completed and is in the process of analysis and write-up. While the study is too underpowered-EX+BR, n=11; EX+PL, n=13-to determine between-group differences in the primary outcomes of COT, PWT, and 6MW, preliminary observations are promising with Cohen d effect sizes of medium to large.
CONCLUSIONS


Exercise training is currently the most effective therapy to increase functional capacity in PAD+IC. If the addition of inorganic nitrate to an exercise regimen elicits greater benefits, it may redefine the current standard of care for PAD+IC.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01684930; https://clinicaltrials.gov/ct2/show/NCT01684930 (Archived by WebCite at http://www.webcitation.org/6raXFyEcP).",2017,"A total of 30 subjects between 40 and 80 years of age with PAD who are limited by IC will undergo exercise training 3 days per week for 12 weeks (ie, 36 sessions).","['Peripheral Artery Disease', 'two groups of PAD+IC patients', '30 subjects between 40 and 80 years of age with PAD who are limited by IC will undergo']","['inorganic nitrate', 'EX+BR versus EX+PL', 'https://clinicaltrials.gov/ct2/show/NCT01684930', 'exercise training', 'beverage high in inorganic nitrate (4.2 mmol) or a low-nitrate placebo', 'Exercise training', 'Combined Dietary Nitrate and Exercise Intervention', 'exercise training plus beetroot (EX+BR) and exercise training plus placebo (EX+PL', 'supervised exercise training, in combination with a high inorganic nitrate-content (beetroot [BR] juice) beverage or placebo (PL) beverage', 'EX+BR or EX+PL']","['vascular health/function via brachial artery flow-mediated dilation, lower-limb blood flow via plethysmography, and pulse wave velocity and reflection', 'quality of life and a high perception of disability', 'changes for (1) exercise capacity: pain-free walking time (claudication onset time, COT), peak walk time (PWT), and maximal exercise capacity (peak oxygen uptake, VO 2peak ) during a maximal-graded cardiopulmonary exercise test (max CPX) and (2) functional capacity: 6-minute walk (6MW) distance', 'ischemic leg pain']","[{'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0442436', 'cui_str': 'Via brachial artery (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0034380'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0340565', 'cui_str': 'Lower limb ischemia (disorder)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",30.0,0.406892,"A total of 30 subjects between 40 and 80 years of age with PAD who are limited by IC will undergo exercise training 3 days per week for 12 weeks (ie, 36 sessions).","[{'ForeName': 'Mary N', 'Initials': 'MN', 'LastName': 'Woessner', 'Affiliation': 'Clinical Exercise Science Research Program, Institute of Sport, Exercise and Active Living, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Mitch D', 'Initials': 'MD', 'LastName': 'VanBruggen', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University Medical Center, Durham, NC, United States.'}, {'ForeName': 'Carl F', 'Initials': 'CF', 'LastName': 'Pieper', 'Affiliation': 'Duke University Medical Center, Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, United States.'}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': ""O'Reilly"", 'Affiliation': 'Office of Regulatory Affairs and Quality, Duke University Medical Center, Durham, NC, United States.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University Medical Center, Durham, NC, United States.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Allen', 'Affiliation': 'Clinical Exercise Science Research Program, Institute of Sport, Exercise and Active Living, Victoria University, Melbourne, Australia.'}]",JMIR research protocols,['10.2196/resprot.7596']
904,31582314,"Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): two double-blind, parallel-group, randomised, controlled phase 3 trials.","BACKGROUND


To date, no studies have assessed the efficacy of single-inhaler triple therapy in asthma. Here we report on two studies that compared the single-inhaler extrafine combination of beclometasone dipropionate (BDP; inhaled corticosteroid), formoterol fumarate (FF; long-acting β 2  agonist), and glycopyrronium (G; long-acting muscarinic antagonist) with the combination of BDP with FF.
METHODS


Two parallel-group, double-blind, randomised, active-controlled, phase 3 trials (Triple in Asthma With Uncontrolled Patients on Medium Strength of ICS + LABA [TRIMARAN] and Triple in Asthma High Strength Versus ICS/LABA HS and Tiotropium [TRIGGER]) recruited patients from 171 sites across 16 countries (TRIMARAN), and from 221 sites across 17 countries (TRIGGER). The sites were a mixture of secondary and tertiary care centres and specialised investigation units. Eligible patients were adults (aged 18-75 years) with uncontrolled asthma, a history of one or more exacerbations in the previous year, and previously treated with inhaled corticosteroid (TRIMARAN: medium dose; TRIGGER: high dose) plus a long-acting β 2  agonist. Enrolled patients were initially treated with BDP/FF (TRIMARAN: 100 μg BDP and 6 μg FF; TRIGGER: 200 μg BDP and 6 μg FF) for 2 weeks, then randomly assigned to treatment using an interactive response technology system with a balanced block randomisation scheme stratified by country. Patients, investigators, site staff, and sponsor staff were masked to BDP/FF/G and BDP/FF assignment. In TRIMARAN, patients were randomly assigned (1:1) to 52 weeks of BDP/FF/G (100 μg BDP, 6 μg FF, and 10 μg G) or BDP/FF (100 μg BDP and 6 μg FF), two inhalations twice daily. In TRIGGER, patients were randomly assigned (2:2:1) to 52 weeks of BDP/FF/G (200 μg BDP, 6 μg FF, and 10 μg G) or BDP/FF (200 BDP and 6 μg FF), both two inhalations twice daily, or open-label BDP/FF (200 μg BDP and 6 μg FF) two inhalations twice daily plus tiotropium 2·5 μg two inhalations once daily. Coprimary endpoints for both trials (BDP/FF/G vs BDP/FF) were pre-dose forced expiratory volume in 1 s (FEV 1 ) at week 26 and rate of moderate and severe exacerbations over 52 weeks. Safety was assessed in all patients who received at least one dose of study treatment. These trials were registered with ClinicalTrials.gov, NCT02676076 (TRIMARAN), NCT02676089 (TRIGGER).
FINDINGS


Between Feb 17, 2016, and May 17, 2018, 1155 patients in TRIMARAN were given BDP/FF/G (n=579) or BDP/FF (n=576). Between April 6, 2016, and May 28, 2018, 1437 patients in TRIGGER were given BDP/FF/G (n=573), BDP/FF (n=576), or BDP/FF plus tiotropium (n=288). Compared with the BDP/FF group, week 26 predose FEV 1  improved in the BDP/FF/G group by 57 mL (95% CI 15-99; p=0·0080) in TRIMARAN and by 73 mL (26-120; p=0·0025) in TRIGGER, with reductions in the rate of moderate and severe exacerbations of 15% (rate ratio 0·85, 95% CI 0·73-0·99; p=0·033) in TRIMARAN and 12% (0·88, 0·75-1·03; p=0·11) in TRIGGER. Four patients had treatment-related serious adverse events, one in TRIMARAN in the BDP/FF/G group and three in TRIGGER-one in the BDP/FF/G and two in the BDP/FF group. Three patients in the BDP/FF/G group in TRIMARAN and two patients in TRIGGER-one in the BDP/FF/G group and one in the BDP/FF group-had adverse events leading to death. None of the deaths were considered as related to treatment.
INTERPRETATION


In uncontrolled asthma, addition of a long-acting muscarinic antagonist to inhaled corticosteroid plus long-acting β 2 -agonist therapy improves lung function and reduces exacerbations.
FUNDING


Chiesi Farmaceutici.",2019,"Four patients had treatment-related serious adverse events, one in TRIMARAN in the BDP/FF/G group and three in TRIGGER-one in the BDP/FF/G and two in the BDP/FF group.","['Eligible patients were adults (aged 18-75 years) with uncontrolled asthma, a history of one or more exacerbations in the previous year, and previously treated with', 'Between Feb 17, 2016, and May 17, 2018, 1155 patients in TRIMARAN were given BDP/FF/G (n=579) or BDP/FF (n=576', 'Between April 6, 2016, and May 28, 2018, 1437 patients in TRIGGER were given BDP/FF/G (n=573), BDP/FF (n=576), or', 'TRIGGER]) recruited patients from 171 sites across 16 countries (TRIMARAN), and from 221 sites across 17 countries (TRIGGER']","['Single inhaler extrafine triple therapy', 'BDP/FF/G', 'inhaled corticosteroid', 'ICS + LABA [TRIMARAN] and Triple in Asthma High Strength Versus ICS/LABA HS and Tiotropium', 'beclometasone dipropionate (BDP; inhaled corticosteroid), formoterol fumarate (FF', 'BDP/FF', 'tiotropium', 'BDP/FF plus tiotropium', 'BDP/FF (200 BDP and 6 μg FF), both two inhalations twice daily, or open-label BDP/FF', 'interactive response technology system with a balanced block randomisation scheme stratified by country']","['lung function and reduces exacerbations', 'serious adverse events', 'rate of moderate and severe exacerbations', 'Safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C0004906', 'cui_str': 'Beclomethasone Dipropionate'}, {'cui': 'C0771469', 'cui_str': 'formoterol fumarate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1437.0,0.610596,"Four patients had treatment-related serious adverse events, one in TRIMARAN in the BDP/FF/G group and three in TRIGGER-one in the BDP/FF/G and two in the BDP/FF group.","[{'ForeName': 'Johann Christian', 'Initials': 'JC', 'LastName': 'Virchow', 'Affiliation': 'Universitätsmedizin Rostock, Zentrum für Innere Medizin, Abteilung für Pneumologie, Rostock, Germany. Electronic address: j.c.virchow@med.uni-rostock.de.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Kuna', 'Affiliation': 'Division of Internal Medicine, Asthma and Allergy, Medical University of Łódź, Łódź, Poland.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Paggiaro', 'Affiliation': 'Department of Surgery, Medicine, Molecular Biology, and Critical Care, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Papi', 'Affiliation': 'Section of Cardiorespiratory and Internal Medicine, Department of Medical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, The University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Corre', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici, Parma, Italy.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Zuccaro', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici, Parma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vele', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici, Parma, Italy.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Kots', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici, Parma, Italy.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Georges', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici, Parma, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Petruzzelli', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici, Parma, Italy.'}, {'ForeName': 'Giorgio Walter', 'Initials': 'GW', 'LastName': 'Canonica', 'Affiliation': 'Humanitas University and Research Hospital, Center of Personalized Medicine: Asthma and Allergy, Milan, Italy.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)32215-9']
905,31476615,Teachers' nonverbal behaviors influence children's stereotypic beliefs.,"The current research tested whether differences in teachers' nonverbal behaviors influence children's intergroup attitudes and stereotypic beliefs. In this study, 5- to 8-year-old participants (N = 96) were assigned to novel groups (marked by T-shirt color) and then viewed interactions between teachers and pairs of students who were also members of the novel groups. Across four interactions, the teacher directed positive nonverbal behaviors toward students from one group and directed negative nonverbal behaviors toward students from another group. After viewing the interactions, participants were presented with pairs of new students from the two novel groups and were asked three types of test questions. When participants were asked who was smarter, they selected new students from the group that had received positive nonverbal behaviors regardless of their own group membership. However, when asked who they would like to befriend, only participants who were assigned to the group that received positive behaviors selected ingroup members. On trials where participants were asked to select a partner on an academic task, participants' selections did not differ from chance. This study shows that teachers' nonverbal behaviors may be one source of children's academic stereotypes, including negative stereotypes about groups to which they belong. Moreover, these findings highlight the importance of subtle social cues in guiding children's beliefs about social groups.",2019,"On trials where participants were asked to select a partner on an academic task, participants' selections did not differ from chance.","['participants were asked who was smarter, they selected new students from the group that had received positive nonverbal behaviors regardless of their own group membership', '5- to 8-year-old participants (N\u202f=\u202f96']",[],"[""Teachers' nonverbal behaviors influence children's stereotypic beliefs""]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]",[],"[{'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",4.0,0.0412505,"On trials where participants were asked to select a partner on an academic task, participants' selections did not differ from chance.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Brey', 'Affiliation': ""Department of Psychology, University of Hawai'i at Manoa, Honolulu, HI 96822, USA. Electronic address: elbrey@hawaii.edu.""}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Pauker', 'Affiliation': ""Department of Psychology, University of Hawai'i at Manoa, Honolulu, HI 96822, USA.""}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.104671']
906,28272294,Use of High-Fidelity Simulation to Enhance Interdisciplinary Collaboration and Reduce Patient Falls.,"OBJECTIVES


This pilot study aimed to determine the effect of nurse/physician interdisciplinary team training on patient falls. Specifically, we evaluated team training in a simulation center as a method for targeting and minimizing breakdowns in perceptions of respect, collaboration, communication, and role misunderstanding behaviors between care disciplines.
METHODS


Registered nurses (RNs) were randomly assigned to participate. Residents were divided into groups and assigned based on their availability and clinical responsibility. All participants completed a demographic form, the Professional Practice Environment Assessment Scale (PPEAS), and the Mayo High Performance Teamwork Scale (MHPTS) after consenting and before participation in simulation training. The PPEAS and the MHPTS were readministered at 2 and 6 months after the simulation experience. Differences in MHPTS and PPEAS scores between the baseline and 2- and 6-month assessments were analyzed; fall rates over time were evaluated using Cochran-Armitage trend tests.
RESULTS


After the team training exercises, teamwork as measured by the MHPTS improved significantly at both 2 and 6 months (P = 0.01; P < 0.001) compared with baseline measurement. Practice environment subscores, with the exception of positive organizational characteristics, also increased when measured 6 months after training. The primary outcome, reduction in anticipated patient falls, improved significantly (P = 0.02) over the course of the study.
CONCLUSIONS


Results of this pilot study show that team training exercises result in improvement in both patient safety (anticipated patient falls) and team member perception of their work environment. If validated by other studies, improvement in this patient safety metric would represent an important benefit of simulation and team training.",2020,"The primary outcome, reduction in anticipated patient falls, improved significantly (P = 0.02) over the course of the study.
","['Registered nurses (RNs', 'patient falls']","['High-Fidelity Simulation', 'nurse/physician interdisciplinary team training']","['reduction in anticipated patient falls', 'MHPTS and PPEAS scores', 'Professional Practice Environment Assessment Scale (PPEAS), and the Mayo High Performance Teamwork Scale (MHPTS']","[{'cui': 'C0687673', 'cui_str': 'Registered nurse (occupation)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033284', 'cui_str': 'Professional Practice'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0222045'}]",,0.0740733,"The primary outcome, reduction in anticipated patient falls, improved significantly (P = 0.02) over the course of the study.
","[{'ForeName': 'April A', 'Initials': 'AA', 'LastName': 'Bursiek', 'Affiliation': 'From the Department of Nursing.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Hopkins', 'Affiliation': 'Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Breitkopf', 'Affiliation': 'Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Grubbs', 'Affiliation': 'From the Department of Nursing.'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Joswiak', 'Affiliation': 'From the Department of Nursing.'}, {'ForeName': 'Janee M', 'Initials': 'JM', 'LastName': 'Klipfel', 'Affiliation': 'Department of Quality: Patient Safety, Mayo Clinic Health System/SE MN Region, Red Wing, Minnesota.'}, {'ForeName': 'Kristine M', 'Initials': 'KM', 'LastName': 'Johnson', 'Affiliation': 'From the Department of Nursing.'}]",Journal of patient safety,['10.1097/PTS.0000000000000277']
907,28249845,Efficacy of Prophylactic Dexmedetomidine in Preventing Postoperative Junctional Ectopic Tachycardia After Pediatric Cardiac Surgery.,"BACKGROUND


Postoperative junctional ectopic tachycardia is one of the most serious arrhythmias that occur after pediatric cardiac surgery, difficult to treat and better to be prevented. Our aim was to assess the efficacy of prophylactic dexmedetomidine in preventing junctional ectopic tachycardia after pediatric cardiac surgery.
METHODS AND RESULTS


A prospective controlled study was carried out on 90 children who underwent elective cardiac surgery for congenital heart diseases. Patients were randomized into 2 groups. Group I (dexmedetomidine group): 60 patients received dexmedetomidine; Group II (Placebo group): 30 patients received the same amount of normal saline intravenously. The primary outcome was the incidence of postoperative junctional ectopic tachycardia. Secondary outcomes included bradycardia, hypotension, vasoactive inotropic score, ventilation time, pediatric cardiac care unit stay, length of hospital stay, and perioperative mortality. The incidence of junctional ectopic tachycardia was significantly reduced in the dexmedetomidine group (3.3%) compared with the placebo group (16.7%) with  P <0.005. Heart rate while coming off cardiopulmonary bypass was significantly lower in the dexmedetomidine group (130.6±9) than the placebo group (144±7.1) with  P <0.001. Mean ventilation time, and mean duration of intensive care unit and hospital stay (days) were significantly shorter in the dexmedetomidine group than the placebo group ( P <0.001). However, there was no significant difference between the 2 groups as regards mortality, bradycardia, or hypotension ( P >0.005).
CONCLUSION


Prophylactic use of dexmedetomidine is associated with significantly decreased incidence of postoperative junctional ectopic tachycardia in children after congenital heart surgery without significant side effects.",2017,"Mean ventilation time, and mean duration of intensive care unit and hospital stay (days) were significantly shorter in the dexmedetomidine group than the placebo group ( P <0.001).","['children after congenital heart surgery', '60 patients received', 'group', '90 children who underwent elective cardiac surgery for congenital heart diseases', 'group): 30 patients']","['normal saline intravenously', 'placebo', 'Placebo', 'Prophylactic Dexmedetomidine', 'dexmedetomidine', 'prophylactic dexmedetomidine']","['junctional ectopic tachycardia', 'postoperative junctional ectopic tachycardia', 'Postoperative Junctional Ectopic Tachycardia', 'regards mortality, bradycardia, or hypotension', 'Heart rate while coming off cardiopulmonary bypass', 'incidence of postoperative junctional ectopic tachycardia', 'bradycardia, hypotension, vasoactive inotropic score, ventilation time, pediatric cardiac care unit stay, length of hospital stay, and perioperative mortality', 'incidence of junctional ectopic tachycardia', 'Mean ventilation time, and mean duration of intensive care unit and hospital stay (days']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease (disorder)'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0039235', 'cui_str': 'Tachycardia, Ectopic Junctional'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care treatments and procedures'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",90.0,0.156418,"Mean ventilation time, and mean duration of intensive care unit and hospital stay (days) were significantly shorter in the dexmedetomidine group than the placebo group ( P <0.001).","[{'ForeName': 'Doaa Mohamed', 'Initials': 'DM', 'LastName': 'El Amrousy', 'Affiliation': 'Pediatric Department, Tanta University Hospital, Tanta, Egypt doaamoha@yahoo.com.'}, {'ForeName': 'Nagat S', 'Initials': 'NS', 'LastName': 'Elshmaa', 'Affiliation': 'Department of Anesthesia & Surgical ICU, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El-Kashlan', 'Affiliation': 'Department of Anesthesia & Surgical ICU, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Hassan', 'Affiliation': 'Pediatric Department, Tanta University Hospital, Tanta, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elsanosy', 'Affiliation': 'Pediatric Department, Tanta University Hospital, Tanta, Egypt.'}, {'ForeName': 'Nahed', 'Initials': 'N', 'LastName': 'Hablas', 'Affiliation': 'Pediatric Department, Tanta University Hospital, Tanta, Egypt.'}, {'ForeName': 'Shimaa', 'Initials': 'S', 'LastName': 'Elrifaey', 'Affiliation': 'Pediatric Department, Tanta University Hospital, Tanta, Egypt.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'El-Feky', 'Affiliation': 'Cardiothoracic Surgery Department, Tanta University Hospital, Tanta, Egypt.'}]",Journal of the American Heart Association,['10.1161/JAHA.116.004780']
908,28230581,A Handoffs Software Led to Fewer Errors of Omission and Better Provider Satisfaction: A Randomized Control Trial.,"BACKGROUND


Computer-assisted communication is shown to prevent critical omissions (""errors"") in the handoff process.
OBJECTIVE


The aim of the study was to study this effect and related provider satisfaction, using a standardized software.
METHODS


Fourteen internal medicine house officers staffed 6 days and 1 cross-covering teams were randomized to either the intervention group or control, employing usual handoff, so that handoff information was exchanged only between same-group subjects (daily, for 28 days).
RESULTS


In the intervention group, fewer omissions (among those studied) occurred intravenous access (17 versus 422, P < 0.001), code status (1 versus 158, P < 0.001), diet/nothing per mouth (28 versus 477, P < 0.001), and deep venous thrombosis prophylaxis (17 versus 284, P < 0.001); duration to compose handoff was similar; and physicians perceived less workload adjusted for patient census and provider characteristics (P = 0.004) as well as better handoff quality (P < 0.001) and clarity (P < 0.001).
CONCLUSIONS


The intervention was associated with fewer errors and superior provider satisfaction.",2020,"In the intervention group, fewer omissions (among those studied) occurred intravenous access (17 versus 422, P < 0.001), code status (1 versus 158, P < 0.001), diet/nothing per mouth (28 versus 477, P < 0.001), and deep venous thrombosis prophylaxis (17 versus 284, P < 0.001); duration to compose handoff was similar; and physicians perceived less workload adjusted for patient census and provider characteristics (P = 0.004) as well as better handoff quality (P < 0.001) and clarity (P < 0.001).
",['Fourteen internal medicine house officers staffed 6 days and 1 cross-covering teams'],"['intervention group or control, employing usual handoff']","['handoff quality', 'fewer errors and superior provider satisfaction', 'intravenous access', 'deep venous thrombosis prophylaxis']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0401975', 'cui_str': 'House officer (occupation)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557351', 'cui_str': 'Employed (finding)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0853245', 'cui_str': 'DVT prophylaxis'}]",,0.138336,"In the intervention group, fewer omissions (among those studied) occurred intravenous access (17 versus 422, P < 0.001), code status (1 versus 158, P < 0.001), diet/nothing per mouth (28 versus 477, P < 0.001), and deep venous thrombosis prophylaxis (17 versus 284, P < 0.001); duration to compose handoff was similar; and physicians perceived less workload adjusted for patient census and provider characteristics (P = 0.004) as well as better handoff quality (P < 0.001) and clarity (P < 0.001).
","[{'ForeName': 'Markos G', 'Initials': 'MG', 'LastName': 'Kashiouris', 'Affiliation': 'From the Division of Pulmonary and Critical Care Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Stefanou', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, National and Kapodistrian University of Athens, Athens Greece.'}, {'ForeName': 'Deepankar', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'From the Division of Pulmonary and Critical Care Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Yshii-Tamashiro', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Tennessee, Knoxville, Tennessee.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Vega', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hartigan', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Albrecht', 'Affiliation': 'Chief Quality Officer, Department of Internal Medicine, Sinai Hospital of Baltimore.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Brown', 'Affiliation': 'Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",Journal of patient safety,['10.1097/PTS.0000000000000340']
909,28138837,Donepezil Plus Solifenacin (CPC-201) Treatment for Alzheimer's Disease.,"Available cholinergic drugs for treating Alzheimer's disease (AD) provide modest symptomatic benefit. We hypothesized that co-administration of a peripheral anticholinergic to reduce dose-limiting adverse effects (AEs) would enable the safe/tolerable use of higher cholinesterase inhibitor doses and thus improve their antidementia efficacy. A modified single-blind, ascending-dose, phase IIa study of donepezil plus solifenacin (CPC-201) lasting 26 weeks was conducted in 41 patients with probable AD of moderate severity. Entry criteria included the use of donepezil at a dose of 10 mg/day during the preceding 3 months. The primary outcome measure was the maximum tolerated dose (MTD) of donepezil achieved (to protocol limit of 40 mg/day) when administered with the anticholinergic solifenacin 15 mg/day. Secondary measures included assessments of cognitive and global function, as well as of AEs. The mean ± SD donepezil MTD increased to 38 ± 0.74 mg/day (median 40 mg/day; p < 0.001); 88% of the study population safely attained this dose at the end of titration. Markedly reduced donepezil AE frequency, especially gastrointestinal, allowed this dose increase. There were no drug-related serious AEs or clinically significant laboratory abnormalities. At 26 weeks, Alzheimer's Disease Assessment Scale Cognitive Component scores in the efficacy evaluable population improved by 0.35 ± 0.85 points over baseline (p < 0.05), an estimated 2.5 ± 0.84 points above 10 mg/day donepezil and 5.4 ± 0.84 points above historic placebo (both p < 0.05). Clinical Global Impression of Improvement scores improved by 0.94 ± 0.20 to 3.1 ± 0.20 points (p < 0.001). The findings suggest that limiting donepezil AEs by co-administration of solifenacin allows the safe administration of substantially higher cholinesterase inhibitors doses that may augment cognitive and global benefits in patients with AD.",2017,Clinical Global Impression of Improvement scores improved by 0.94 ± 0.20 to 3.1 ± 0.20 points (p < 0.001).,"['41 patients with probable AD of moderate severity', ""Alzheimer's Disease"", 'patients with AD']","['donepezil', 'Donepezil Plus Solifenacin (CPC-201', 'solifenacin', 'donepezil plus solifenacin', 'anticholinergic solifenacin']","[""Alzheimer's Disease Assessment Scale Cognitive Component scores"", 'mean\u2009±\u2009SD donepezil MTD', 'maximum tolerated dose (MTD) of donepezil', 'assessments of cognitive and global function, as well as of AEs', 'Clinical Global Impression of Improvement scores', 'donepezil AE frequency, especially gastrointestinal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}]","[{'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1099677', 'cui_str': 'Solifenacin'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}]","[{'cui': 'C0450989', 'cui_str': ""Alzheimer's disease assessment scale (assessment scale)""}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0752079', 'cui_str': 'Maximally Tolerated Dose'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",41.0,0.199273,Clinical Global Impression of Improvement scores improved by 0.94 ± 0.20 to 3.1 ± 0.20 points (p < 0.001).,"[{'ForeName': 'Thomas N', 'Initials': 'TN', 'LastName': 'Chase', 'Affiliation': 'Chase Pharmaceuticals, Inc, 1825 K Street NW, Washington, DC, 20006, USA. tchase@chasetherapeutics.com.'}, {'ForeName': 'Martin R', 'Initials': 'MR', 'LastName': 'Farlow', 'Affiliation': 'Department of Neurology, Indiana University School of Medicine, 541 Clinical Drive, CL299, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Clarence-Smith', 'Affiliation': 'Chase Pharmaceuticals, Inc, 1825 K Street NW, Washington, DC, 20006, USA.'}]",Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics,['10.1007/s13311-016-0511-x']
910,31576791,"Cariprazine efficacy in bipolar I depression with and without concurrent manic symptoms: post hoc analysis of 3 randomized, placebo-controlled studies.","OBJECTIVE.


Mixed presentations, defined by simultaneous occurrence of depressive and manic symptoms, are difficult to treat. Antidepressants, although commonly used, have weak evidence of efficacy and may increase risk of mood destabilization. The aim of this pooled post hoc analysis was to evaluate the efficacy of cariprazine in the treatment of bipolar depression with or without concurrent manic symptoms.
METHODS.


Patients from 3 randomized, double-blind, placebo-controlled studies who met DSM-IV-TR or DSM-5 criteria for bipolar I disorder with a current major depressive episode were identified to have concurrent manic symptoms by baseline Young Mania Rating Scale total score ≥4. Efficacy was assessed in cariprazine 1.5 and 3 mg/day dose groups versus placebo; analyses included the least squares mean change from baseline to week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
RESULTS.


Of 1383 patients randomized to treatment, 808 (58.4%) had concurrent manic symptoms. For patients with manic symptoms, mean reduction in MADRS total score from baseline to week 6 was significantly greater for both cariprazine 1.5 and 3 mg/day compared with placebo, with least squares mean differences (LSMDs) versus placebo of -2.5 (p = .0033) and -2.9 (p = .0010), respectively; for patients without manic symptoms, the LSMD was significant for 1.5 mg/day (-3.3; p = .0008), but not for 3 mg/day (-1.9; p = .0562).
CONCLUSION.


The results of this post hoc analysis suggest that cariprazine may be an appropriate treatment option for patients with bipolar I depression with or without manic symptoms, with higher doses potentially more effective in patients with manic symptoms.",2020,"For patients with manic symptoms, mean reduction in MADRS total score from baseline to week 6 was significantly greater for both cariprazine 1.5 and 3 mg/day compared with placebo, with least squares mean differences (LSMDs) versus placebo of -2.5 (p = .0033) and -2.9 (","['patients with bipolar I depression with or without manic symptoms', '1383 patients randomized to treatment, 808 (58.4%) had concurrent manic symptoms', 'bipolar I depression with and without concurrent manic symptoms', 'controlled studies who met DSM-IV-TR or DSM-5 criteria for bipolar I disorder with a current major depressive episode were identified to have concurrent manic symptoms by baseline Young Mania Rating Scale total score ≥4']","['placebo', 'cariprazine']","['Montgomery-Åsberg Depression Rating Scale (MADRS) total score', 'Cariprazine efficacy', 'Efficacy', 'MADRS total score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder (disorder)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936870', 'cui_str': 'cariprazine'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2936870', 'cui_str': 'cariprazine'}]",1383.0,0.224252,"For patients with manic symptoms, mean reduction in MADRS total score from baseline to week 6 was significantly greater for both cariprazine 1.5 and 3 mg/day compared with placebo, with least squares mean differences (LSMDs) versus placebo of -2.5 (p = .0033) and -2.9 (","[{'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, California, USA.'}, {'ForeName': 'Willie', 'Initials': 'W', 'LastName': 'Earley', 'Affiliation': 'Clinical Development, Allergan, Madison, New Jersey, USA.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Medical Affairs, Allergan, Madison, New Jersey, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Stahl', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, California, USA.'}]",CNS spectrums,['10.1017/S1092852919001287']
911,31564754,What do Workplace Wellness Programs do? Evidence from the Illinois Workplace Wellness Study.,"Workplace wellness programs cover over 50 million U.S. workers and are intended to reduce medical spending, increase productivity, and improve well-being. Yet limited evidence exists to support these claims. We designed and implemented a comprehensive workplace wellness program for a large employer and randomly assigned program eligibility and financial incentives at the individual level for nearly 5,000 employees. We find strong patterns of selection: during the year prior to the intervention, program participants had lower medical expenditures and healthier behaviors than nonparticipants. The program persistently increased health screening rates, but we do not find significant causal effects of treatment on total medical expenditures, other health behaviors, employee productivity, or self-reported health status after more than two years. Our 95% confidence intervals rule out 84% of previous estimates on medical spending and absenteeism.",2019,"The program persistently increased health screening rates, but we do not find significant causal effects of treatment on total medical expenditures, other health behaviors, employee productivity, or self-reported health status after more than two years.",['program participants had lower medical expenditures and healthier behaviors than nonparticipants'],['comprehensive workplace wellness program'],"['health screening rates', 'total medical expenditures, other health behaviors, employee productivity, or self-reported health status', 'medical spending and absenteeism']","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0043113', 'cui_str': 'Wellness Programs'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0018687'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}]",,0.0189631,"The program persistently increased health screening rates, but we do not find significant causal effects of treatment on total medical expenditures, other health behaviors, employee productivity, or self-reported health status after more than two years.","[{'ForeName': 'Damon', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'University of Chicago and NBER.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Molitor', 'Affiliation': 'University of Illinois and NBER.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Reif', 'Affiliation': 'University of Illinois and NBER.'}]",The quarterly journal of economics,['10.1093/qje/qjz023']
912,28024268,Validation of autonomic and endocrine reactivity to a laboratory stressor in young children.,"The validation of laboratory paradigms that reliably induce a stress response [including hypothalamic-pituitary-adrenal (HPA) axis and autonomic nervous system (ANS) activation], is critical for understanding how children's stress-response systems support emotional and cognitive function. Early childhood research to date is markedly limited, given the difficulty in establishing paradigms that reliably induce a cortisol response. Furthermore, research to date has not included a control condition or examined concurrent ANS reactivity. We addressed these limitations by characterizing the extent to which a modified matching task stressor paradigm induces HPA and ANS activation, beyond a closely matched control condition. Modifications include an unfamiliar and unfriendly assessor to increase the stressful nature of the task. Results validate the matching task as a laboratory stressor, with significant differences in HPA and ANS responsivity between conditions. The Stressor group exhibited a cortisol increase post-stressor, while the Control group was stable over time. Children in both conditions exhibited reduced parasympathetic activity to the first-half of the task, but in the second-half, only children in the Stressor condition, who were experiencing exaggerated signals of failure, exhibited further parasympathetic decline. The Stressor condition induced higher sympathetic activity (versus Control) throughout the task, with exaggerated second-half differences. Within the Stressor condition, responsivity was convergent across systems, with greater cortisol reactivity correlated with the magnitude of parasympathetic withdrawal and sympathetic engagement. Future research employing the matching task will facilitate understanding the role of HPA and ANS function in development.",2017,"The Stressor condition induced higher sympathetic activity (versus Control) throughout the task, with exaggerated second-half differences.",['young children'],[],"['parasympathetic activity', 'HPA and ANS responsivity', 'stressful nature of the task', 'stress response [including hypothalamic-pituitary-adrenal (HPA) axis and autonomic nervous system (ANS) activation', 'sympathetic activity', 'cortisol reactivity']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]",[],"[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0966198', 'cui_str': ""P(1)-(6-hydroxymethylpterin)-P(4)-(5'-adenosyl)tetraphosphate""}, {'cui': 'C1262865', 'cui_str': 'Natures (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0004388', 'cui_str': 'Visceral Nervous System'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",,0.0113798,"The Stressor condition induced higher sympathetic activity (versus Control) throughout the task, with exaggerated second-half differences.","[{'ForeName': 'Leslie E', 'Initials': 'LE', 'LastName': 'Roos', 'Affiliation': 'University of Oregon, Department of Psychology, 1227 University of Oregon, Eugene, OR, USA. Electronic address: lroos@uoregon.edu.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Giuliano', 'Affiliation': 'University of Oregon, Department of Psychology, 1227 University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Beauchamp', 'Affiliation': 'University of Oregon, Department of Psychology, 1227 University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Gunnar', 'Affiliation': 'University of Minnesota, Institute of Child Development, 51 E River Road, Minneapolis, MN, USA.'}, {'ForeName': 'Brigette', 'Initials': 'B', 'LastName': 'Amidon', 'Affiliation': 'University of Oregon, Department of Psychology, 1227 University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Fisher', 'Affiliation': 'University of Oregon, Department of Psychology, 1227 University of Oregon, Eugene, OR, USA.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2016.11.023']
913,28003500,Relationship between risk factor control and vascular events in the SAMMPRIS trial.,"OBJECTIVE


The Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study is the first stroke prevention trial to include protocol-driven intensive management of multiple risk factors. In this prespecified analysis, we aimed to investigate the relationship between risk factor control during follow-up and outcome of patients in the medical arm of SAMMPRIS.
METHODS


Data from SAMMPRIS participants in the medical arm (n = 227) were analyzed. Risk factors were recorded at baseline, 30 days, 4 months, and then every 4 months for a mean follow-up of 32 months. For each patient, values for all risk factor measures were averaged and dichotomized as in or out of target.
RESULTS


Participants who were out of target for systolic blood pressure and physical activity, as well as those with higher mean low-density lipoprotein cholesterol and non-high-density lipoprotein, were more likely to have a recurrent vascular event (stroke, myocardial infarction, or vascular death) at 3 years compared to those who had good risk factor control. In the multivariable analysis, greater physical activity decreased the likelihood of a recurrent stroke, myocardial infarction, or vascular death (odds ratio 0.6, confidence interval 0.4-0.8).
CONCLUSIONS


Raised blood pressure, cholesterol, and physical inactivity should be aggressively treated in patients with intracranial atherosclerosis to prevent future vascular events. Physical activity, which has not received attention in stroke prevention trials, was the strongest predictor of a good outcome in the medical arm in SAMMPRIS.
CLINICALTRIALSGOV IDENTIFIER


NCT00576693.",2017,"In the multivariable analysis, greater physical activity decreased the likelihood of a recurrent stroke, myocardial infarction, or vascular death (odds ratio 0.6, confidence interval 0.4-0.8).
","['Data from SAMMPRIS participants in the medical arm (n = 227', 'patients in the medical arm of SAMMPRIS', 'patients with intracranial atherosclerosis']",[],"['mean low-density lipoprotein cholesterol and non-high-density lipoprotein', 'recurrent vascular event (stroke, myocardial infarction, or vascular death', 'systolic blood pressure and physical activity', 'Risk factors', 'physical activity decreased the likelihood of a recurrent stroke, myocardial infarction, or vascular death']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751007', 'cui_str': 'Intracranial Atherosclerosis'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",227.0,0.0386988,"In the multivariable analysis, greater physical activity decreased the likelihood of a recurrent stroke, myocardial infarction, or vascular death (odds ratio 0.6, confidence interval 0.4-0.8).
","[{'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'From Medical University of South Carolina (T.N.T., M.F.L.-V., K.L.H., J.H., M.I.C.), Charleston; Emory University (A.N., M.J.L., B.L., J.M.), Atlanta, GA; University of South Carolina School of Medicine (B.M.E.), Greenville; Atlanta VAMC (N.-A.L.), Decatur, GA; Washington University (C.P.D.), St. Louis, MI; State University of New York at Stony Brook (D.F.); and National Institute of Neurological Disorders and Stroke (L.S.J.), Bethesda, MD. turan@musc.edu.'}, {'ForeName': 'Azhar', 'Initials': 'A', 'LastName': 'Nizam', 'Affiliation': 'From Medical University of South Carolina (T.N.T., M.F.L.-V., K.L.H., J.H., M.I.C.), Charleston; Emory University (A.N., M.J.L., B.L., J.M.), Atlanta, GA; University of South Carolina School of Medicine (B.M.E.), Greenville; Atlanta VAMC (N.-A.L.), Decatur, GA; Washington University (C.P.D.), St. Louis, MI; State University of New York at Stony Brook (D.F.); and National Institute of Neurological Disorders and Stroke (L.S.J.), Bethesda, MD.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Lynn', 'Affiliation': 'From Medical University of South Carolina (T.N.T., M.F.L.-V., K.L.H., J.H., M.I.C.), Charleston; Emory University (A.N., M.J.L., B.L., J.M.), Atlanta, GA; University of South Carolina School of Medicine (B.M.E.), Greenville; Atlanta VAMC (N.-A.L.), Decatur, GA; Washington University (C.P.D.), St. Louis, MI; State University of New York at Stony Brook (D.F.); and National Institute of Neurological Disorders and Stroke (L.S.J.), Bethesda, MD.'}, {'ForeName': 'Brent M', 'Initials': 'BM', 'LastName': 'Egan', 'Affiliation': 'From Medical University of South Carolina (T.N.T., M.F.L.-V., K.L.H., J.H., M.I.C.), Charleston; Emory University (A.N., M.J.L., B.L., J.M.), Atlanta, GA; University of South Carolina School of Medicine (B.M.E.), Greenville; Atlanta VAMC (N.-A.L.), Decatur, GA; Washington University (C.P.D.), St. Louis, MI; State University of New York at Stony Brook (D.F.); and National Institute of Neurological Disorders and Stroke (L.S.J.), Bethesda, MD.'}, {'ForeName': 'Ngoc-Anh', 'Initials': 'NA', 'LastName': 'Le', 'Affiliation': 'From Medical University of South Carolina (T.N.T., M.F.L.-V., K.L.H., J.H., M.I.C.), Charleston; Emory University (A.N., M.J.L., B.L., J.M.), Atlanta, GA; University of South Carolina School of Medicine (B.M.E.), Greenville; Atlanta VAMC (N.-A.L.), Decatur, GA; Washington University (C.P.D.), St. Louis, MI; State University of New York at Stony Brook (D.F.); and National Institute of Neurological Disorders and Stroke (L.S.J.), Bethesda, MD.'}, {'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Lopes-Virella', 'Affiliation': 'From Medical University of South Carolina (T.N.T., M.F.L.-V., K.L.H., J.H., M.I.C.), Charleston; Emory University (A.N., M.J.L., B.L., J.M.), Atlanta, GA; University of South Carolina School of Medicine (B.M.E.), Greenville; Atlanta VAMC (N.-A.L.), Decatur, GA; Washington University (C.P.D.), St. Louis, MI; State University of New York at Stony Brook (D.F.); and National Institute of Neurological Disorders and Stroke (L.S.J.), Bethesda, MD.'}, {'ForeName': 'Kathie L', 'Initials': 'KL', 'LastName': 'Hermayer', 'Affiliation': 'From Medical University of South Carolina (T.N.T., M.F.L.-V., K.L.H., J.H., M.I.C.), Charleston; Emory University (A.N., M.J.L., B.L., J.M.), Atlanta, GA; University of South Carolina School of Medicine (B.M.E.), Greenville; Atlanta VAMC (N.-A.L.), Decatur, GA; Washington University (C.P.D.), St. Louis, MI; State University of New York at Stony Brook (D.F.); and National Institute of Neurological Disorders and Stroke (L.S.J.), Bethesda, MD.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Harrell', 'Affiliation': 'From Medical University of South Carolina (T.N.T., M.F.L.-V., K.L.H., J.H., M.I.C.), Charleston; Emory University (A.N., M.J.L., B.L., J.M.), Atlanta, GA; University of South Carolina School of Medicine (B.M.E.), Greenville; Atlanta VAMC (N.-A.L.), Decatur, GA; Washington University (C.P.D.), St. Louis, MI; State University of New York at Stony Brook (D.F.); and National Institute of Neurological Disorders and Stroke (L.S.J.), Bethesda, MD.'}, {'ForeName': 'Colin P', 'Initials': 'CP', 'LastName': 'Derdeyn', 'Affiliation': 'From Medical University of South Carolina (T.N.T., M.F.L.-V., K.L.H., J.H., M.I.C.), Charleston; Emory University (A.N., M.J.L., B.L., J.M.), Atlanta, GA; University of South Carolina School of Medicine (B.M.E.), Greenville; Atlanta VAMC (N.-A.L.), Decatur, GA; Washington University (C.P.D.), St. Louis, MI; State University of New York at Stony Brook (D.F.); and National Institute of Neurological Disorders and Stroke (L.S.J.), Bethesda, MD.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fiorella', 'Affiliation': 'From Medical University of South Carolina (T.N.T., M.F.L.-V., K.L.H., J.H., M.I.C.), Charleston; Emory University (A.N., M.J.L., B.L., J.M.), Atlanta, GA; University of South Carolina School of Medicine (B.M.E.), Greenville; Atlanta VAMC (N.-A.L.), Decatur, GA; Washington University (C.P.D.), St. Louis, MI; State University of New York at Stony Brook (D.F.); and National Institute of Neurological Disorders and Stroke (L.S.J.), Bethesda, MD.'}, {'ForeName': 'L Scott', 'Initials': 'LS', 'LastName': 'Janis', 'Affiliation': 'From Medical University of South Carolina (T.N.T., M.F.L.-V., K.L.H., J.H., M.I.C.), Charleston; Emory University (A.N., M.J.L., B.L., J.M.), Atlanta, GA; University of South Carolina School of Medicine (B.M.E.), Greenville; Atlanta VAMC (N.-A.L.), Decatur, GA; Washington University (C.P.D.), St. Louis, MI; State University of New York at Stony Brook (D.F.); and National Institute of Neurological Disorders and Stroke (L.S.J.), Bethesda, MD.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Lane', 'Affiliation': 'From Medical University of South Carolina (T.N.T., M.F.L.-V., K.L.H., J.H., M.I.C.), Charleston; Emory University (A.N., M.J.L., B.L., J.M.), Atlanta, GA; University of South Carolina School of Medicine (B.M.E.), Greenville; Atlanta VAMC (N.-A.L.), Decatur, GA; Washington University (C.P.D.), St. Louis, MI; State University of New York at Stony Brook (D.F.); and National Institute of Neurological Disorders and Stroke (L.S.J.), Bethesda, MD.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Montgomery', 'Affiliation': 'From Medical University of South Carolina (T.N.T., M.F.L.-V., K.L.H., J.H., M.I.C.), Charleston; Emory University (A.N., M.J.L., B.L., J.M.), Atlanta, GA; University of South Carolina School of Medicine (B.M.E.), Greenville; Atlanta VAMC (N.-A.L.), Decatur, GA; Washington University (C.P.D.), St. Louis, MI; State University of New York at Stony Brook (D.F.); and National Institute of Neurological Disorders and Stroke (L.S.J.), Bethesda, MD.'}, {'ForeName': 'Marc I', 'Initials': 'MI', 'LastName': 'Chimowitz', 'Affiliation': 'From Medical University of South Carolina (T.N.T., M.F.L.-V., K.L.H., J.H., M.I.C.), Charleston; Emory University (A.N., M.J.L., B.L., J.M.), Atlanta, GA; University of South Carolina School of Medicine (B.M.E.), Greenville; Atlanta VAMC (N.-A.L.), Decatur, GA; Washington University (C.P.D.), St. Louis, MI; State University of New York at Stony Brook (D.F.); and National Institute of Neurological Disorders and Stroke (L.S.J.), Bethesda, MD.'}]",Neurology,['10.1212/WNL.0000000000003534']
914,31813423,Effect of task-oriented training on balance and motor function of ambulant children with cerebral palsy.,"INTRODUCTION AND OBJECTIVES


The study evaluated the effect of task-oriented training (TOT) on the motor function (MF) and balance of ambulant children with cerebral palsy (CP).
MATERIALS AND METHODS


A total of 46 children were randomised into TOT group (n=23) and Control Group (CG [n=23]), but 39 children complete the study. Balance and MF were assessed at baseline, 6th and 12th weeks and 6 weeks post-intervention. Data were analysed with repeated measures ANOVA, Friedman's, Mann-Whitney U, Student's-t and post hoc tests at α≤0.05.
RESULTS


The two groups were comparable in all baseline scores (P>0.05). At the 6th week, significant between-group difference was observed in MF only [TOT=81.9 (18.5); CG=72.8 (19.4)] (P<0.05). There were significant between-group differences in MF [TOT=88.8 (9.4); CG=75.5 (18.5); P<0.05] and balance (TOT=9.4±4.5; CG=13.6±6.9; P<0.05) at the 12th week (P<0.05) and 6 weeks post-intervention (P<0.05).
CONCLUSION


TOT improved the balance and MF of ambulant children with CP.",2019,There were significant between-group differences in MF,"['n=23]), but 39 children complete the study', 'ambulant children with cerebral palsy (CP', 'ambulant children with cerebral palsy', 'ambulant children with CP', '46 children']","['task-oriented training', 'task-oriented training (TOT', 'Control Group (CG', 'TOT']","['Balance and MF', 'balance and MF', 'MF']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",46.0,0.0188711,There were significant between-group differences in MF,"[{'ForeName': 'O O', 'Initials': 'OO', 'LastName': 'Ogwumike', 'Affiliation': 'Department of Physiotherapy, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}, {'ForeName': 'U M', 'Initials': 'UM', 'LastName': 'Badaru', 'Affiliation': 'Department of Physiotherapy, Faculty of Allied Health Sciences, Bayero University, Kano, Nigeria. Electronic address: umbadaru.pth@buk.edu.ng.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Adeniyi', 'Affiliation': 'Department of Physiotherapy, College of Medicine, University of Ibadan, Ibadan, Nigeria.'}]",Rehabilitacion,['10.1016/j.rh.2019.07.003']
915,28004273,Occipital Nerve Field Transcranial Direct Current Stimulation Normalizes Imbalance Between Pain Detecting and Pain Inhibitory Pathways in Fibromyalgia.,"Occipital nerve field (OCF) stimulation with subcutaneously implanted electrodes is used to treat headaches, more generalized pain, and even failed back surgery syndrome via unknown mechanisms. Transcranial direct current stimulation (tDCS) can predict the efficacy of implanted electrodes. The purpose of this study is to unravel the neural mechanisms involved in global pain suppression, mediated by occipital nerve field stimulation, within the realm of fibromyalgia. Nineteen patients with fibromyalgia underwent a placebo-controlled OCF tDCS. Electroencephalograms were recorded at baseline after active and sham stimulation. In comparison with healthy controls, patients with fibromyalgia demonstrate increased dorsal anterior cingulate cortex, increased premotor/dorsolateral prefrontal cortex activity, and an imbalance between pain-detecting dorsal anterior cingulate cortex and pain-suppressing pregenual anterior cingulate cortex activity, which is normalized after active tDCS but not sham stimulation associated with increased pregenual anterior cingulate cortex activation. The imbalance improvement between the pregenual anterior cingulate cortex and the dorsal anterior cingulate cortex is related to clinical changes. An imbalance assumes these areas communicate and, indeed, abnormal functional connectivity between the dorsal anterior cingulate cortex and pregenual anterior cingulate cortex is noted to be caused by a dysfunctional effective connectivity from the pregenual anterior cingulate cortex to the dorsal anterior cingulate cortex, which improves and normalizes after real tDCS but not sham tDCS. In conclusion, OCF tDCS exerts its effect via activation of the descending pain inhibitory pathway and de-activation of the salience network, both of which are abnormal in fibromyalgia.",2017,"In comparison with healthy controls, patients with fibromyalgia demonstrate increased dorsal anterior cingulate cortex, increased premotor/dorsolateral prefrontal cortex activity, and an imbalance between pain-detecting dorsal anterior cingulate cortex and pain-suppressing pregenual anterior cingulate cortex activity, which is normalized after active tDCS but not sham stimulation associated with increased pregenual anterior cingulate cortex activation.","['Fibromyalgia', 'Nineteen patients with fibromyalgia underwent a']","['placebo-controlled OCF tDCS', 'Occipital Nerve Field Transcranial Direct Current Stimulation Normalizes Imbalance', 'Occipital nerve field (OCF) stimulation with subcutaneously implanted electrodes', 'OCF tDCS', 'Transcranial direct current stimulation (tDCS']","['pregenual anterior cingulate cortex activation', 'dorsal anterior cingulate cortex, increased premotor/dorsolateral prefrontal cortex activity, and an imbalance between pain-detecting dorsal anterior cingulate cortex and pain-suppressing pregenual anterior cingulate cortex activity']","[{'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C1283707', 'cui_str': 'Occipital nerve'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0013814', 'cui_str': 'Implantable Electrodes'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}]",19.0,0.019517,"In comparison with healthy controls, patients with fibromyalgia demonstrate increased dorsal anterior cingulate cortex, increased premotor/dorsolateral prefrontal cortex activity, and an imbalance between pain-detecting dorsal anterior cingulate cortex and pain-suppressing pregenual anterior cingulate cortex activity, which is normalized after active tDCS but not sham stimulation associated with increased pregenual anterior cingulate cortex activation.","[{'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'De Ridder', 'Affiliation': 'Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Vanneste', 'Affiliation': 'Department of Surgical Sciences, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand. sven.vanneste@utdallas.edu.'}]",Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics,['10.1007/s13311-016-0493-8']
916,27765556,Impact of the New American Heart Association/American Stroke Association Definition of Stroke on the Results of the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis Trial.,"BACKGROUND


An American Heart Association/American Stroke Association (AHA/ASA) writing committee has recently recommended that tissue evidence of cerebral infarction associated with temporary symptoms (CITS) lasting <24 hours should be considered a stroke. We analyzed the impact of considering CITS as equivalent to stroke on the results of the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial.
METHODS


We compared outcomes in the medical (n = 227) and stenting (n = 224) groups in SAMMPRIS using the following primary end point (new components in bold): any stroke, CITS, or death within 30 days after enrollment or within 30 days after a revascularization procedure for the qualifying lesion during follow-up; or ischemic stroke or CITS in the territory of the qualifying artery beyond 30 days. We also compared the use of brain magnetic resonance imaging (MRI) after transient ischemic attacks (TIAs) in both treatment groups.
RESULTS


By considering CITS as equivalent to stroke, the number of primary end points increased from 34 to 43 in the medical group and from 52 to 66 in the stenting group of SAMMPRIS. The Kaplan-Meier curves for the primary end points in the 2 groups were significantly different (P = .009). The percentage of patients with reported TIAs who underwent brain MRI was 69% in the medical group and 61% in the stenting group (P = .40).
CONCLUSION


Using the AHA/ASA definition of stroke resulted in a substantially higher primary end point rate in both treatment groups and an even higher benefit from medical therapy over stenting than originally shown in SAMMPRIS. The higher rate of CITS in the stenting group was not due to ascertainment bias.",2017,The Kaplan-Meier curves for the primary end points in the 2 groups were significantly different (P = .009).,[],['brain magnetic resonance imaging (MRI'],"['brain MRI', 'Kaplan-Meier curves', 'higher rate of CITS']",[],"[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0607063', 'cui_str': 'serum P-component'}]",,0.0516243,The Kaplan-Meier curves for the primary end points in the 2 groups were significantly different (P = .009).,"[{'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Al Kasab', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina. Electronic address: alkasab@musc.edu.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Lynn', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public, Health, Atlanta, Georgia.'}, {'ForeName': 'Tanya N', 'Initials': 'TN', 'LastName': 'Turan', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Colin P', 'Initials': 'CP', 'LastName': 'Derdeyn', 'Affiliation': 'Department of Radiology, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fiorella', 'Affiliation': 'Department of Neurosurgery, State University of New York, Stony Brook, New York.'}, {'ForeName': 'Bethany F', 'Initials': 'BF', 'LastName': 'Lane', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Emory University Rollins School of Public, Health, Atlanta, Georgia.'}, {'ForeName': 'L Scott', 'Initials': 'LS', 'LastName': 'Janis', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Marc I', 'Initials': 'MI', 'LastName': 'Chimowitz', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2016.08.038']
917,27478520,The Method of Randomization for Cluster-Randomized Trials: Challenges of Including Patients with Multiple Chronic Conditions.,"Cluster-randomized clinical trials (CRT) are trials in which the unit of randomization is not a participant but a group (e.g. healthcare systems or community centers). They are suitable when the intervention applies naturally to the cluster (e.g. healthcare policy); when lack of independence among participants may occur (e.g. nursing home hygiene); or when it is most ethical to apply an intervention to all within a group (e.g. school-level immunization). Because participants in the same cluster receive the same intervention, CRT may approximate clinical practice, and may produce generalizable findings. However, when not properly designed or interpreted, CRT may induce biased results. CRT designs have features that add complexity to statistical estimation and inference. Chief among these is the cluster-level correlation in response measurements induced by the randomization. A critical consideration is the experimental unit of inference; often it is desirable to consider intervention effects at the level of the individual rather than the cluster. Finally, given that the number of clusters available may be limited, simple forms of randomization may not achieve balance between intervention and control arms at either the cluster- or participant-level. In non-clustered clinical trials, balance of key factors may be easier to achieve because the sample can be homogenous by exclusion of participants with multiple chronic conditions (MCC). CRTs, which are often pragmatic, may eschew such restrictions. Failure to account for imbalance may induce bias and reducing validity. This article focuses on the complexities of randomization in the design of CRTs, such as the inclusion of patients with MCC, and imbalances in covariate factors across clusters.",2016,"In non-clustered clinical trials, balance of key factors may be easier to achieve because the sample can be homogenous by exclusion of participants with multiple chronic conditions (MCC).","['Patients with Multiple Chronic Conditions', 'participants with multiple chronic conditions (MCC']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3266262', 'cui_str': 'Multi'}]",[],[],,0.0510695,"In non-clustered clinical trials, balance of key factors may be easier to achieve because the sample can be homogenous by exclusion of participants with multiple chronic conditions (MCC).","[{'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Esserman', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut, USA.'}, {'ForeName': 'Heather G', 'Initials': 'HG', 'LastName': 'Allore', 'Affiliation': 'Department of Biostatistics, Yale School of Public Health, New Haven, Connecticut, USA; Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Travison', 'Affiliation': 'Department of Medicine, Harvard Medical School, Cambridge, Massachusetts, USA; Hebrew SeniorLife Institute for Aging Research, Roslindale, Massachusetts, USA.'}]",International journal of statistics in medical research,[]
918,31859599,Intra-Rater Reliability and Agreement of the Indurometer When Used to Assess Mid-Calf Tissue Compressibility Among People Affected by Moderate to Severe Lymphedema in Bangladesh and Ethiopia.,"Background:  Lymphedema is a chronic skin disease that induces tissue fibrosis (stiffness). Tissue tonometry has been used to assess skin and tissue compressibility in lymphedema, primarily in research on arm lymphedema after breast cancer. A digital tonometer, the Indurometer (Flinders and SA Biomedical Engineering, Australia), has shown excellent intra-rater reliability in young healthy people in Australia and Myanmar and was able to detect covert changes in young, asymptomatic Myanmar people infected with lymphatic filariasis. It has not been tested in overt lower-limb lymphedema.  Methods and Results:  The Indurometer was used in a cluster randomized trial in Bangladesh and Ethiopia to measure tissue compressibility among adults affected by moderate to severe lymphatic filariasis- or podoconiosis-related leg lymphedema. The study compared different self-care intervention and after baseline there were follow-ups at 4, 12, and 24 weeks. Three consecutive Indurometer scores were collected by two data collection teams in each country at the mid-calf of each leg. Indurometer scores were available for three time-points in Bangladesh and four time-points in Ethiopia. An intra-class correlation coefficient (ICC) was calculated for each data collection team, and a coefficient of variation (CV) was used to assess measurement agreement in moderate and severe stages of lymphedema. The intra-rater reliability among local research assistants was good to excellent in both countries at all time-points (ICC range 0.829 [95% confidence interval; CI 0.730-0.896]-0.992 [95% CI 0.989-0.995]). In Bangladesh, agreement between measures was highest among unaffected legs (range 16%-22%) and lowest in severe lymphedema (range 19%-39%). CV scores in Ethiopia showed no distinct pattern for lymphedema stage (range 15%-32%).  Conclusion:  The Indurometer is an inexpensive and easy-to-use device to assess skin and tissue compressibility and should be considered in clinical research on lower-limb lymphedema.",2020,"In Bangladesh, agreement between measures was highest among unaffected legs (range 16%-22%) and lowest in severe lymphedema (range 19%-39%).","['young healthy people in Australia and Myanmar', 'adults affected by moderate to severe lymphatic filariasis- or podoconiosis-related leg lymphedema']",[],"['Mid-Calf Tissue Compressibility', 'CV scores', 'severe lymphedema']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0013884', 'cui_str': 'Bancroftian Elephantiasis'}, {'cui': 'C1280469', 'cui_str': 'Lymphostatic Verrucosis'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}]",[],"[{'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}]",,0.0395787,"In Bangladesh, agreement between measures was highest among unaffected legs (range 16%-22%) and lowest in severe lymphedema (range 19%-39%).","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Douglass', 'Affiliation': 'Department of Tropical Disease Biology, Centre for Neglected Tropical Diseases, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Mableson', 'Affiliation': 'Department of Tropical Disease Biology, Centre for Neglected Tropical Diseases, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Martindale', 'Affiliation': 'Department of Tropical Disease Biology, Centre for Neglected Tropical Diseases, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Jahirul', 'Initials': 'J', 'LastName': 'Karim', 'Affiliation': 'Bangladesh Ministry of Health and Family Welfare, Filariasis Elimination Program, Dhaka, Bangladesh.'}, {'ForeName': 'Asm Sultan', 'Initials': 'AS', 'LastName': 'Mahmood', 'Affiliation': 'Bangladesh Ministry of Health and Family Welfare, Filariasis Elimination Program, Dhaka, Bangladesh.'}, {'ForeName': 'Fikre', 'Initials': 'F', 'LastName': 'Hailekiros', 'Affiliation': 'National Podoconiosis Action Network, Addis Ababa, Ethiopia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kelly-Hope', 'Affiliation': 'Department of Tropical Disease Biology, Centre for Neglected Tropical Diseases, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}]",Lymphatic research and biology,['10.1089/lrb.2019.0060']
919,31570942,Modification of Blood Test Draw Order to Reduce Blood Culture Contamination: A Randomized Clinical Trial.,"BACKGROUND


Blood culture contamination leads to unnecessary interventions and costs. It may be caused by bacteria in deep skin structures unsusceptible to surface decontamination. This study was designed to test whether diversion of blood obtained at venipuncture into a lithium heparin tube prior to aspiration of blood culture reduces contamination.
METHODS


The order of blood draws for biochemistry and blood cultures was randomized. Following standard disinfection and venipuncture, blood was either aspirated into a sterile lithium heparin tube before blood culture bottles (diversion group) or blood cultures first and then lithium heparin tube (control group). All study personnel were blinded with the exception of the phlebotomist.
RESULTS


After exclusions, 970 blood culture/biochemistry sets were analyzed. Contamination occurred in 24 of 480 (5.0%) control vs 10 of 490 (2.0%) diversion group cultures (P = .01). True pathogens were identified in 26 of 480 (5.4%) control vs 18 of 490 (3.7%) diversion cultures (P = .22). Despite randomization, demographic differences were apparent between the 2 groups. A post hoc analysis of 637 cultures from 610 medical patients admitted from home neutralized demographic differences. Culture contamination remained more frequent in the control vs diversion group (17/312 [5%] vs 7/325 [2%]; P = .03). Fewer diversion group patients were admitted to hospital (control: 200/299 [66.9%] vs diversion: 182/311 [58.5%]; P = .03), and length of stay was shorter (control: 30 hours [interquartile range {IQR}, 6-122] vs diversion: 22 [IQR, 5-97]; P = .02).
CONCLUSIONS


Use of lithium heparin tubes for diversion prior to obtaining blood cultures led to a 60% decrease in contamination. This technique is easy and inexpensive and might decrease overall hospital length of stay.
CLINICAL TRIALS REGISTRATION


NCT03966534.",2020,"Culture contamination remained more frequent in the control versus diversion group (17/312, 5% versus 7/325, 2%, p=0.03).",['610 medical patients admitted from home neutralized demographic differences'],"['standard disinfection and venipuncture, blood was either aspirated into a sterile lithium-heparin tube before blood culture bottles (diversion group) or blood cultures first and then lithium-heparin tube (control group', 'lithium-heparin']","['length of stay', 'Contamination', 'blood culture contamination', 'overall hospital length of stay', 'Culture contamination']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012683', 'cui_str': 'Disinfection'}, {'cui': 'C0600406', 'cui_str': 'Venipuncture (procedure)'}, {'cui': 'C0005768'}, {'cui': 'C0370199', 'cui_str': 'Aspirate'}, {'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}, {'cui': 'C0185033', 'cui_str': 'Diversion'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0220814', 'cui_str': 'culture'}]",970.0,0.038686,"Culture contamination remained more frequent in the control versus diversion group (17/312, 5% versus 7/325, 2%, p=0.03).","[{'ForeName': 'Frederic S', 'Initials': 'FS', 'LastName': 'Zimmerman', 'Affiliation': 'Critical Care Unit, Shaare Zedek Medical Center, affiliated with the Hebrew University-Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Karameh', 'Affiliation': 'Department of Geriatrics, Shaare Zedek Medical Center, affiliated with the Hebrew University-Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Ben-Chetrit', 'Affiliation': 'Infectious Disease Unit, Shaare Zedek Medical Center, affiliated with the Hebrew University-Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Zalut', 'Affiliation': 'Department of Emergency Medicine, Shaare Zedek Medical Center, affiliated with the Hebrew University-Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Assous', 'Affiliation': 'Laboratory of Clinical Microbiology and Immunology, Shaare Zedek Medical Center, affiliated with the Hebrew University-Hadassah Medical School, Jerusalem, Israel.'}, {'ForeName': 'Phillip D', 'Initials': 'PD', 'LastName': 'Levin', 'Affiliation': 'Critical Care Unit, Shaare Zedek Medical Center, affiliated with the Hebrew University-Hadassah Medical School, Jerusalem, Israel.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz971']
920,31563396,"Portable Accelerometer-Based Navigation System for Cup Placement of Total Hip Arthroplasty: A Prospective, Randomized, Controlled Study.","BACKGROUND


Malposition of the acetabular component during total hip arthroplasty (THA) is associated with increased risk of dislocation, reduced range of motion, and accelerated wear. The purpose of this study is to compare cup positioning with a portable, accelerometer-based hip navigation system and conventional surgical technique.
METHODS


In a prospective, randomized, clinical study, cups were implanted with a portable, accelerometer-based hip navigation system (navigation group; n = 55) or conventional technique (conventional group; n = 55). THA was conducted in the lateral position and through posterior approach. The cup position was determined postoperatively on pelvic radiograph and computed tomography scans.
RESULTS


An average cup abduction of 39.2° ± 4.6° (range, 27° to 50°) and an average cup anteversion of 14.6° ± 6.1° (range, 1° to 27.5°) were found in the navigation group, and an average cup abduction of 42.9° ± 8.0° (range, 23° to 73°) and an average cup anteversion of 11.6° ± 7.7° (range, -12.1° to 25°) in the conventional group. A smaller variation in the navigation group was indicated for cup abduction (P = .001). The deviations from the target cup position were significantly lower in the navigation group (P = .001, .016). While only 37 of 55 cups in the conventional group were inside the Lewinnek safe zone, 51 of 55 cups in the navigation group were placed inside this safe zone (P = .006). The navigation procedure took a mean of 10 minutes longer than the conventional technique.
CONCLUSION


Use of the portable, accelerometer-based hip navigation system can improve cup positioning in THA.",2020,"The deviations from the target cup position were significantly lower in the navigation group (P = .001, .016).","['Total Hip Arthroplasty', 'An average cup abduction of 39.2° ± 4.6° (range, 27° to 50°) and an average cup anteversion of 14.6° ± 6.1° (range, 1° to 27.5°) were found in the navigation group, and an average cup abduction of 42.9° ± 8.0° (range, 23° to 73°) and an average cup anteversion of 11.6° ± 7.7° (range']","['Portable Accelerometer-Based Navigation System', 'portable, accelerometer-based hip navigation system (navigation group; n\xa0= 55) or conventional technique (conventional group; n\xa0= 55', 'cup positioning with a portable, accelerometer-based hip navigation system and conventional surgical technique']",['cup abduction'],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C4517764', 'cui_str': 'Four point six'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0333053', 'cui_str': 'Anteversion (morphologic abnormality)'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517773', 'cui_str': 'Forty-two point nine'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}]",,0.0281631,"The deviations from the target cup position were significantly lower in the navigation group (P = .001, .016).","[{'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Tanino', 'Affiliation': 'Department of Orthopaedic Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Nishida', 'Affiliation': 'Department of Orthopaedic Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Mitsutake', 'Affiliation': 'Department of Orthopaedic Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Orthopaedic Surgery, Asahikawa Medical University, Asahikawa, Japan.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.08.044']
921,27535752,"Three doses of vitamin D, bone mineral density, and geometry in older women during modest weight control in a 1-year randomized controlled trial.","The effects of higher than recommended vitamin D doses on bone mineral density (BMD) and quality are not known. In this study, higher intakes, in postmenopausal women undergoing weight control over 1 year, had no effect on areal or volumetric BMD but prevented the deterioration in cortical bone geometry.
INTRODUCTION


Studies examining how bone responds to a standard dose of vitamin D supplementation have been inconsistent. In addition, the effects of higher doses on BMD and quality are not known. Postmenopausal women undergoing weight control to improve health outcomes are particularly at risk for bone loss and might benefit from supplemental vitamin D intake above the recommended allowance.
METHODS


This 1-year-long, randomized, double-blind controlled study addresses whether vitamin D supplementation, in healthy overweight/obese older women, affects BMD and bone structural parameters. In addition, bone turnover and serum total, free, and bioavailable 25-hydroxyvitamin D (25OHD) responses to one of three daily levels of vitamin D 3  (600, 2000, 4000 IU) with 1.2 Ca g/day during weight control were examined.
RESULTS


Fifty-eight women (age, 58 ± 6 years; body mass index, 30.2 ± 3.8 kg/m 2 , serum 25OHD, 27.3 ± 4.4 ng/mL) were randomized to treatment. After 1 year, serum 25OHD concentrations increased to 26.5 ± 4.4, 35.9 ± 4.5, and 41.5 ± 6.9 ng/mL, in groups 600, 2000, and 4000 IU, respectively, and differed between groups (p < 0.01). Weight change was similar between groups (-3.0 ± 4.1 %). Cortical (Ct) thickness of the tibia changed by -1.5 ± 5.1 %, +0.6 ± 3.2 %, and +2.0 ± 4.5 % in groups 600, 2000, and 4000 IU, respectively, and each group was significantly different from each other (p < 0.05).
CONCLUSION


The decline in Ct thickness was prevented with higher vitamin D 3  supplementation, but there were no other significant changes due to treatment over 1 year. Whether these findings translate to changes in biomechanical properties leading to reduced fracture risk should be addressed in future studies.",2017,"The decline in Ct thickness was prevented with higher vitamin D 3  supplementation, but there were no other significant changes due to treatment over 1 year.","['postmenopausal women undergoing weight control over 1\xa0year', 'healthy overweight/obese older women', 'older women during modest weight control', 'Fifty-eight women (age, 58\u2009±', '6\xa0years; body mass index, 30.2\u2009±\u20093.8\xa0kg/m 2 , serum 25OHD, 27.3\u2009±\u20094.4\xa0ng/mL', 'Postmenopausal women undergoing']","['weight control', 'vitamin D', 'vitamin D supplementation']","['serum 25OHD concentrations', 'Weight change', 'bone turnover and serum total, free, and bioavailable 25-hydroxyvitamin D (25OHD) responses', 'decline in Ct thickness', 'Cortical (Ct) thickness of the tibia changed', 'bone mineral density (BMD) and quality', 'areal or volumetric BMD', 'BMD and quality']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen (regime/therapy)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen (regime/therapy)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0040184', 'cui_str': 'Tibia'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}]",58.0,0.295983,"The decline in Ct thickness was prevented with higher vitamin D 3  supplementation, but there were no other significant changes due to treatment over 1 year.","[{'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Pop', 'Affiliation': 'Department of Nutritional Sciences, Rutgers University, 96 Lipman Drive, New Brunswick, NJ, 08901-8525, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sukumar', 'Affiliation': 'Department of Nutritional Sciences, Drexel University, Philadelphia, PA, USA.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Schneider', 'Affiliation': 'Division of Endocrinology, Metabolism and Nutrition, Department of Medicine, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Schlussel', 'Affiliation': 'Department of Nutritional Sciences, Rutgers University, 96 Lipman Drive, New Brunswick, NJ, 08901-8525, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Stahl', 'Affiliation': 'Department of Radiology, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gordon', 'Affiliation': 'Department of Radiology, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Division of Endocrinology, Metabolism and Nutrition, Department of Medicine, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Papathomas', 'Affiliation': 'Department of Biomedical Engineering & Center for Cognitive Science, Rutgers University, New Brunswick, NJ, USA.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Shapses', 'Affiliation': 'Department of Nutritional Sciences, Rutgers University, 96 Lipman Drive, New Brunswick, NJ, 08901-8525, USA. shapses@aesop.rutgers.edu.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-016-3735-z']
922,31565750,Hemagglutinin Stalk Antibody Responses Following Trivalent Inactivated Influenza Vaccine Immunization of Pregnant Women and Association With Protection From Influenza Virus Illness.,"BACKGROUND


The conserved, immuno-subdominant influenza virus hemagglutinin (HA) stalk region is a potential universal group-specific influenza virus vaccine epitope. We analyzed antibody responses to H1 hemagglutinin stalk domain (H1/stalk) following trivalent influenza inactivated vaccine (IIV3) immunization in pregnant women, and association with protection against influenza virus illness.
METHODS


One hundred forty-five human immunodeficiency virus (HIV)-uninfected pregnant women (68 IIV3 and 77 placebo recipients) and 140 pregnant women with HIV infection (72 IIV3 and 68 placebo recipients) were independently randomized in placebo-controlled efficacy trials of IIV3. Plasma samples were tested for H1/stalk immunoglobulin G (IgG) and hemagglutination inhibition (HAI) antibodies prevaccination and 1 month postvaccination. Women had weekly surveillance for influenza illness, confirmed by polymerase chain reaction.
RESULTS


Increases in H1/stalk IgG (and HAI) antibody levels were elicited post-IIV3, with responses being higher in HIV-uninfected women than in women living with HIV. Among HIV-uninfected vaccinees, there was no correlation (postvaccination) between H1/stalk and HAI antibody responses, whereas a strong correlation was observed in vaccinees with HIV. The H1/stalk IgG concentration was lower among women developing A/H1N1 illness (85.3 arbitrary units [AU]/mL) than those without A/H1N1 illness (219.6 AU/mL; P = .001). H1/stalk IgG concentration ≥215 AU/mL was associated with 90% lower odds (odds ratio, 0.09; P = .005) of A/H1N1 illness. Also, H1/stalk IgG was significantly lower among women with influenza B illness (93.9 AU/mL) than among their counterparts (215.5 AU/mL) (P = .04); however, no association was observed after adjusting for HAI titers.
CONCLUSIONS


H1/stalk IgG concentration was associated with lower odds for A/H1N1 influenza virus illness, indicating its potential as an epitope for a universal vaccine against group 1 influenza virus.",2020,"FINDINGS


Increases in H1/stalk IgG (and HAI) antibody levels were elicited post-IIV3; with responses being higher in HIV-uninfected than HIV-infected women.","['pregnant women and association with protection from influenza virus illness', 'pregnant women, and association with protection against influenza virus illness', 'One-hundred and forty-five', 'pregnant women']","['placebo', 'trivalent inactivated influenza vaccine immunization', 'placebo-recipients', 'H1 hemagglutinin stalk-domain (H1/stalk) following trivalent influenza inactivated vaccine (IIV3) vaccination']","['H1/stalk IgG', 'H1/stalk IgG concentration', 'H1/stalk IgG (and HAI) antibody levels']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C4316910', 'cui_str': 'Influenzavirus'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C4517577', 'cui_str': '145'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0935572', 'cui_str': 'Stalkings'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0935572', 'cui_str': 'Stalkings'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",145.0,0.059227,"FINDINGS


Increases in H1/stalk IgG (and HAI) antibody levels were elicited post-IIV3; with responses being higher in HIV-uninfected than HIV-infected women.","[{'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Dhar', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Kwatra', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Marta C', 'Initials': 'MC', 'LastName': 'Nunes', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Cutland', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Alane', 'Initials': 'A', 'LastName': 'Izu', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Raffael', 'Initials': 'R', 'LastName': 'Nachbagauer', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krammer', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, USA.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz927']
923,32413530,Cranberry capsules are not superior to placebo capsules in managing acute non-haemorrhagic radiation cystitis in prostate cancer patients: A phase III double blinded randomised placebo controlled clinical trial.,"PURPOSE


Acute radiation cystitis affects the quality of life of many prostate cancer patients. A previous pilot study suggested that cranberry capsules may decrease some of the symptoms of acute radiation cystitis. Here we further test their effectiveness in a multicentre double blinded placebo-controlled clinical trial.
MATERIAL AND METHODS


A total of 108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019. Out of this cohort, 101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules). Patients took two capsules each morning during RT and for 2 weeks after completion of RT. Three measures were used to assess cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS). Cystitis severity was scored at baseline and weekly thereafter during RT and for two weeks after completion of RT. Radiation protocols were stratified to conventional fractionation or hypo-fractionated radiation therapy (CHHiP) to the prostate or radiation to the prostate bed.
RESULTS


Cranberry capsules performed significantly worse than placebo capsules with respect to day time frequency and bladder control, using the more sensitive RICAS scale. No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
CONCLUSION


Cranberry capsules were not superior to beetroot-containing placebo capsules in managing radiation cystitis in our prostate patient cohort. RICAS may be a useful tool for measuring radiation cystitis in future studies.",2020,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
","['101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules', 'many prostate cancer patients', 'prostate cancer patients', '108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019']","['conventional fractionation or hypo-fractionated radiation therapy (CHHiP', 'Cranberry capsules', 'placebo capsules', 'RICAS', 'cranberry capsules', 'placebo']","['Cystitis severity', 'sensitive RICAS scale', 'symptoms of acute radiation cystitis', 'cystitis severity', ""cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]","[{'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0403637', 'cui_str': 'Acute radiation cystitis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C0205314', 'cui_str': 'New'}]",108.0,0.254135,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland.
","[{'ForeName': 'Patries M', 'Initials': 'PM', 'LastName': 'Herst', 'Affiliation': 'Department of Radiation Therapy, University of Otago, Wellington, New Zealand. Electronic address: patries.herst@otago.ac.nz.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Aumata', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Sword', 'Affiliation': 'Kathleen Kilgour Centre, Tauranga, New Zealand.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Auckland Radiation Oncology, Epsom, New Zealand.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Purdie', 'Affiliation': ""Dean's Department, University of Otago, Wellington, New Zealand.""}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Costello', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.006']
924,27599452,"Using Tablet Computers to Increase Patient Engagement With Electronic Personal Health Records: Protocol For a Prospective, Randomized Interventional Study.","BACKGROUND


Inadequate patient engagement in care is a major barrier to successful transitions from the inpatient setting and can lead to preventable adverse events after discharge, particularly for older adults. While older adults may be less familiar with mobile devices and applications, they may benefit from focused bedside training to engage them in using their Personal Health Record (PHR). Mobile technologies such as tablet computers can be used in the hospital to help bridge this gap in experience by teaching older, hospitalized patients to actively manage their medication list through their PHR during hospitalization and continue to use their PHR for other post-discharge tasks such as scheduling follow-up appointments, viewing test results, and communicating with providers. Bridging this gap is especially important for older, hospitalized adults as they are at higher risk than younger populations for low engagement in transitions of care and poor outcomes such as readmission. Greater understanding of the advantages and limitations of mobile devices for older adults may be important for improving transitions of care.
OBJECTIVE


To better understand the effective use of mobile technologies to improve transitions in care for hospitalized, older adults and leverage these technologies to improve inpatient and postdischarge care for older adults.
METHODS


We will compare an intervention group with tablet-based training to engage effectively with their PHR to a control group also receiving tablets and basic access to their PHR but no additional training on how to engage with their PHR.
RESULTS


Patient enrollment is ongoing.
CONCLUSIONS


Through this grant, we will further develop our preliminary dataset and practical experience with these mobile technologies to catalyze patient engagement during hospitalization.
CLINICALTRIAL


ClinicalTrials.gov NCT02109601; https://clinicaltrials.gov/ct2/show/NCT02109601 (Archived by WebCite at http://www.webcitation.org/6jpXjkwM8).",2016,"We will compare an intervention group with tablet-based training to engage effectively with their PHR to a control group also receiving tablets and basic access to their PHR but no additional training on how to engage with their PHR.
",['older adults'],['mobile technologies'],[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}]",[],,0.0568593,"We will compare an intervention group with tablet-based training to engage effectively with their PHR to a control group also receiving tablets and basic access to their PHR but no additional training on how to engage with their PHR.
","[{'ForeName': 'S Ryan', 'Initials': 'SR', 'LastName': 'Greysen', 'Affiliation': 'University of California, San Francisco, Division of Hospital Medicine, San Francisco, CA, United States. ryan.greysen@gmail.com.'}, {'ForeName': 'Yimdriuska', 'Initials': 'Y', 'LastName': 'Magan Mendoza', 'Affiliation': ''}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Rosenthal', 'Affiliation': ''}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Jacolbia', 'Affiliation': ''}, {'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Rajkomar', 'Affiliation': ''}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Auerbach', 'Affiliation': ''}]",JMIR research protocols,['10.2196/resprot.4672']
925,32416376,Accelerating prostate stereotactic ablative body radiotherapy: Efficacy and toxicity of a randomized phase II study of 11 versus 29 days overall treatment time (PATRIOT).,"BACKGROUND


Prostate stereotactic ablative radiotherapy (SABR) regimens differ in time, dose, and fractionation. We report an update of a multicentre, Canadian randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL), efficacy, and toxicity.
METHODS


Men with intermediate risk prostate cancer were randomized to 40 Gy in 5 fractions delivered every other day (EOD) versus once per week (QW). Primary outcome was proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC. Secondary outcomes were toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy.
FINDINGS


152 men from 3 centers were randomized; the median follow-up was 62 months. Results are described for EOD versus QW. Acute bowel and urinary QOL was reported previously. Late changes in QOL were not significantly different between the two arms. There were 1 (1.3%) vs 3 (2.7%) late grade 3 + GI toxicities (p = 0.36) and 5 (6.7%) vs 2 (2.7%) late grade 3 GU toxicities (p = 0.44). Two and 5 patients had BF (5-year failure rate 3.0 vs 7.2%, p = 0.22); 0 and 4 patients received salvage therapy (p = 0.04). 5-Year OS and CSS was 95.8% and 98.6% with no difference between arms (p = 0.49, p = 0.15). 3 patients in the QW arm developed metastases.
INTERPRETATION


Although we previously reported that weekly prostate SABR had better bowel and urinary QOL compared to EOD, the updated results show no difference in late toxicity, QOL, BF, or PSA kinetics. Patients should be counseled that QW SABR reduces short-term toxicity compared to QW SABR.",2020,Late changes in QOL were not significantly different between the two arms.,"['152 men from 3 centers', 'Men with intermediate risk prostate cancer']","['Accelerating prostate stereotactic ablative body radiotherapy', 'salvage therapy', 'Prostate stereotactic ablative radiotherapy (SABR']","['late toxicity, QOL, BF, or PSA kinetics', 'Late changes in QOL', 'proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC', 'Acute bowel and urinary QOL', 'bowel and urinary QOL', 'metastases', 'BF (5-year failure rate', 'late grade 3 GU toxicities', 'toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy', '5-Year OS and CSS', 'quality of life (QOL), efficacy, and toxicity', 'late grade 3\xa0+\xa0GI toxicities']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",152.0,0.180251,Late changes in QOL were not significantly different between the two arms.,"[{'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Alayed', 'Affiliation': 'Radiation Oncology Unit, Department of Medicine, College of Medicine and College of Medicine Research Center, King Saud University, Saudi Arabia; Oncology Center, King Saud University Medical City, Saudi Arabia; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Canada.'}, {'ForeName': 'Aldrich', 'Initials': 'A', 'LastName': 'Ong', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cheung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Vesprini', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Chowdhury', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Dilip', 'Initials': 'D', 'LastName': 'Panjwani', 'Affiliation': 'BC Cancer Agency, Abbotsford, Canada.'}, {'ForeName': 'Geordi', 'Initials': 'G', 'LastName': 'Pang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Korol', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ananth', 'Initials': 'A', 'LastName': 'Ravi', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Boyd', 'Initials': 'B', 'LastName': 'McCurdy', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mamedov', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Deabreu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Institute of Health Policy Management and Evaluation, University of Toronto, Canada. Electronic address: andrew.loblaw@sunnybrook.ca.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.04.039']
926,32415981,Association of hyponatraemia and renal function in type 1 cardiorenal syndrome.,"BACKGROUND


Hyponatraemia predicts type 1 cardiorenal syndrome in acute decompensated heart failure patients, which associates with poor outcome. Recovery from hyponatraemia has been found to associate with better outcome in acute decompensated heart failure patients, but its prognostic value regarding renal function remains unknown.
METHODS


We performed a secondary analysis of CARRESS-HF trial, and all patients included had worsening renal function (≥0.3 mg/dL increase in serum creatinine than the nadir). The serum sodium levels of patients were evaluated at baseline and day 4 and day 7 after randomization. Patients were grouped according to the status of hyponatraemia: recovery from hyponatraemia; no hyponatraemia; persistent hyponatraemia; and new-onset hyponatraemia. Their associations with persistent worsening renal function (serum creatinine ≥ 0.3 mg/dL higher than the nadir at discharge) were explored.
RESULTS


A total of 118 patients suffered from persistent worsening renal function. Baseline hyponatraemia was not associated with persistent worsening renal function (odds ratio = 0.495, P = .086). Patients in the recovery from hyponatraemia group had a lowest risk of persistent worsening renal function among the study population. Further, baseline serum sodium level was not associated with the risk of persistent worsening renal function (odds ratio = 1.055, P = .233), while the increases in serum sodium level at day 4 (odds ratio = 0.858, P = .003) and at day 7 (odds ratio = 0.821, P < .001) significantly predicted a lower risk of persistent worsening renal function.
CONCLUSIONS


Recovery from hyponatraemia associates with a lower risk of persistent worsening renal function, suggesting that hyponatraemia correction may improve renal outcomes in acute decompensated heart failure patients with type 1 cardiorenal syndrome.",2020,"Baseline hyponatremia was not associated with persistent worsening renal function (odds ratio=0.495, P=0.086).","['acute decompensated heart failure patients', 'Patients were grouped according to the status of hyponatremia: recovery from hyponatremia, no hyponatremia, persistent hyponatremia, and new-onset hyponatremia', 'acute decompensated heart failure patients with type 1 cardiorenal syndrome', 'Type 1 Cardiorenal syndrome', '118 patients suffered from persistent worsening renal function']",[],"['renal outcomes', 'risk of persistent worsening renal function', 'worsening renal function', 'serum sodium level', 'Baseline hyponatremia', 'serum sodium levels', 'baseline serum sodium level']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2242703', 'cui_str': 'Cardiorenal syndrome'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",[],"[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}]",118.0,0.0620905,"Baseline hyponatremia was not associated with persistent worsening renal function (odds ratio=0.495, P=0.086).","[{'ForeName': 'Weihao', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Ruicong', 'Initials': 'R', 'LastName': 'Xue', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Fangfei', 'Initials': 'F', 'LastName': 'Wei', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zexuan', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Marvin', 'Initials': 'M', 'LastName': 'Owusu-Agyeman', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuzhong', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yugang', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}]",European journal of clinical investigation,['10.1111/eci.13269']
927,31227681,Wide-detector CT combined iterative reconstruction in pediatric low-dose scan of the paranasal sinus.,"BACKGROUND


Computed tomography (CT) is considered a standard modality for imaging the paranasal sinus (PS), but increasingly radiation dose is of concern, especially in children.
OBJECTIVE


This study aims to investigate the feasibility of using a 320-detector CT scanner with a 16 cm wide-detector combined with iterative reconstruction (IR) algorithm to further reduce radiation dose when scanning the PS.
METHODS


A total of 90 children who underwent CT of the PS were randomly allocated into three groups namely, (1) the experimental group using low-dose wide-detector scan (n = 30, 9±4 years); (2) low-dose helical group (n = 30, 9±4 years); and (3) pediatric conventional group (n = 30, 8±4 years). Statistical software SPSS 19.0 was used for one-way ANOVA analysis of the general data (age, BMI), image quality, and radiation dose. Multiple comparisons of data without homogeneity of variance were analyzed by Bonferroni test and Tamhane's test.
RESULTS


All patients underwent successful CT examinations. No significant differences in the general data and image quality evaluation were detected between three groups (all P values > 0.05). CTDIvol and DLP were 2.87 mGy and 32.58 mGy·cm in the experimental group, 4.92 mGy and 70.84 mGy·cm in the low-dose helical group, and 9.95 mGy and 131.83 mGy·cm in the conventional group, respectively, which were significantly different among these three groups as indicated by multiple comparisons (all P values < 0.05). In the experimental group, the effective radiation dose was 0.07 mSv, which was reduced by 76% and 56% comparing to the conventional group and the low-dose helical group, respectively.
CONCLUSIONS


The 320-detector CT scanner equipped with the wide-detector combined with IR can further reduce radiation dose, while maintaining good image quality comparing to the low-dose helical or pediatric modes.",2019,No significant differences in the general data and image quality evaluation were detected between three groups (all P values > 0.05).,['A total of 90 children who underwent CT of the PS'],"['Wide-detector CT combined iterative reconstruction', '320-detector CT scanner with a 16 cm wide-detector combined with iterative reconstruction (IR) algorithm', 'experimental group using low-dose wide-detector scan', 'Computed tomography (CT']","['general data and image quality evaluation', 'CTDIvol and DLP']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0002045'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0441633'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",90.0,0.0243493,No significant differences in the general data and image quality evaluation were detected between three groups (all P values > 0.05).,"[{'ForeName': 'Que', 'Initials': 'Q', 'LastName': 'Kong', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi Second Hospital, Wuxi, China.'}, {'ForeName': 'Fengqi', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi Second Hospital, Wuxi, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi Second Hospital, Wuxi, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Qiao', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi Second Hospital, Wuxi, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Shao', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi Second Hospital, Wuxi, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xie', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi Second Hospital, Wuxi, China.'}]",Journal of X-ray science and technology,['10.3233/XST-180487']
928,32492705,Moderate-Intensity Exercise and High-Intensity Interval Training Affect Insulin Sensitivity Similarly in Obese Adults.,"OBJECTIVE


We compared the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) on insulin sensitivity and other important metabolic adaptations in adults with obesity.
METHODS


Thirty-one inactive adults with obesity (age: 31 ± 6 years; body mass index: 33 ± 3 kg/m2) completed 12 weeks (4 sessions/week) of either HIIT (10 × 1-minute at 90%HRmax, 1-minute active recovery; n = 16) or MICT (45 minutes at 70%HRmax; n = 15). To assess the direct effects of exercise independent of weight/fat loss, participants were required to maintain body mass.
RESULTS


Training increased peak oxygen uptake by ~10% in both HIIT and MICT (P < 0.0001), and body weight/fat mass were unchanged. Peripheral insulin sensitivity (hyperinsulinemic-euglycemic clamp) was ~20% greater the day after the final exercise session compared to pretraining (P < 0.01), with no difference between HIIT and MICT. When trained participants abstained from exercise for 4 days, insulin sensitivity returned to pretraining levels in both groups. HIIT and MICT also induced similar increases in abundance of many skeletal muscle proteins involved in mitochondrial respiration and lipid and carbohydrate metabolism. Training-induced alterations in muscle lipid profile were also similar between groups.
CONCLUSION


Despite large differences in training intensity and exercise time, 12 weeks of HIIT and MICT induce similar acute improvements in peripheral insulin sensitivity the day after exercise, and similar longer term metabolic adaptations in skeletal muscle in adults with obesity. These findings support the notion that the insulin-sensitizing effects of both HIIT and MICT are mediated by factors stemming from the most recent exercise session(s) rather than adaptations that accrue with training.",2020,HIIT and MICT also induced similar increases in abundance of many skeletal muscle proteins involved in mitochondrial respiration and lipid and carbohydrate metabolism.,"['adults with obesity', 'obese adults', 'Thirty-one inactive adults with obesity (age: 31±6 years, BMI: 33±3 kg/m2) completed 12 weeks (4 sessions/week) of either HIIT (10x1-minute at 90%HRmax, 1-minute active recovery; n=16) or']","['MICT', 'high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT', 'HIIT and MICT', 'Moderate-intensity exercise and high-intensity interval training']","['muscle lipid profile', 'peak oxygen uptake', 'insulin sensitivity', 'Peripheral insulin sensitivity (hyperinsulinemic-euglycemic clamp', 'body weight/fat mass']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",31.0,0.0721815,HIIT and MICT also induced similar increases in abundance of many skeletal muscle proteins involved in mitochondrial respiration and lipid and carbohydrate metabolism.,"[{'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Ryan', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Schleh', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Cheehoon', 'Initials': 'C', 'LastName': 'Ahn', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Ludzki', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Jenna B', 'Initials': 'JB', 'LastName': 'Gillen', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Pallavi', 'Initials': 'P', 'LastName': 'Varshney', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Douglas W', 'Initials': 'DW', 'LastName': 'Van Pelt', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Pitchford', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Chenevert', 'Affiliation': 'Department of Radiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Gioscia-Ryan', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Suzette M', 'Initials': 'SM', 'LastName': 'Howton', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rode', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Hummel', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Burant', 'Affiliation': 'Division of Metabolism, Endocrinology, and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'School of Health and Exercise Sciences, University of British Columbia, Okanagan Campus, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Jeffrey F', 'Initials': 'JF', 'LastName': 'Horowitz', 'Affiliation': 'Substrate Metabolism Laboratory, School of Kinesiology, University of Michigan, Ann Arbor, Michigan.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa345']
929,31566573,Outcomes of rotational atherectomy versus modified balloon angioplasty in severely calcified coronary lesions based on target lesion location: a post hoc analysis of the PREPARE-CALC randomised trial.,,2020,,['severely calcified coronary lesions'],['rotational atherectomy versus modified balloon angioplasty prior to drug-eluting stent implantation'],[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0162655', 'cui_str': 'Rotational Atherectomy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0002996', 'cui_str': 'Dilation, Transluminal Arterial'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]",[],,0.0860408,,"[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Rheude', 'Affiliation': 'Deutsches Herzzentrum, Munich, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Toelg', 'Affiliation': ''}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Byrne', 'Affiliation': ''}, {'ForeName': 'Abdelhakim', 'Initials': 'A', 'LastName': 'Allali', 'Affiliation': ''}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Wiebe', 'Affiliation': ''}, {'ForeName': 'Dmitriy S', 'Initials': 'DS', 'LastName': 'Sulimov', 'Affiliation': ''}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Voll', 'Affiliation': ''}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cassese', 'Affiliation': ''}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': ''}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00488']
930,26903399,Hepatic Effects of Estrogen on Plasma Distribution of Small Dense Low-Density Lipoprotein and Free Radical Production in Postmenopausal Women.,"AIM


Hepatic effects of estrogen therapy on low-density lipoprotein (LDL) subfraction or oxidative stress have not been previously evaluated. The purpose of the present study was to investigate whether the differential hepatic effects of estrogen affect plasma distribution of small dense LDL and free radical production in postmenopausal women.
METHODS


In all, 45 postmenopausal women were given 0.625 mg/day of oral conjugated equine estrogen (CEE) (n=15), 1.0 mg/day of oral 17β estradiol (E2) (n=15), or 50 μg/day of transdermal 17βE2 (n=15) for 3 months. Subjects received either estrogen alone or with dydrogesterone at 5 mg/day. Plasma concentrations of sex hormone-binding globulin (SHBG), lipids, metallic ions, and derivatives of reactive oxygen metabolites (d-ROMs) were measured.
RESULTS


CEE, but not oral 17βE2, increased the plasma concentrations of triglyceride, copper (Cu), and d-ROMs and the ratio of small dense LDL/total LDL cholesterol, a marker for plasma distribution of small dense LDL. Transdermal 17βE2 decreased d-ROMs concentrations but did not significantly change other parameters. Plasma concentrations of SHBG increased in the 3 groups. Estrogen-induced changes in triglyceride correlated positively either with changes in SHBG (R=0.52, P=0.0002) or the ratio of small dense LDL/total LDL cholesterol (R=0.65, P＜0.0001). Changes in Cu also correlated positively either with changes in SHBG (R=0.85, P＜0.0001) or d-ROMs (R=0.86, P＜0.0001).
CONCLUSION


The hepatic effects of different routes or types of estrogen therapy may be associated with plasma distribution of small dense LDL and free radical production in postmenopausal women.",2016,Plasma concentrations of SHBG increased in the 3 groups.,"['postmenopausal women', 'Postmenopausal Women', '45 postmenopausal women']","['estrogen alone or with dydrogesterone', 'transdermal 17βE2', 'Estrogen', 'oral conjugated equine estrogen (CEE', 'oral 17β estradiol (E2', 'estrogen therapy']","['ratio of small dense LDL/total LDL cholesterol', 'SHBG', 'plasma concentrations of triglyceride, copper (Cu), and d-ROMs and the ratio of small dense LDL/total LDL cholesterol, a marker for plasma distribution of small dense LDL', 'Transdermal 17βE2 decreased d-ROMs concentrations', 'Plasma concentrations of sex hormone-binding globulin (SHBG), lipids, metallic ions, and derivatives of reactive oxygen metabolites (d-ROMs', 'low-density lipoprotein (LDL) subfraction or oxidative stress', 'Plasma Distribution of Small Dense Low-Density Lipoprotein and Free Radical Production', 'Plasma concentrations of SHBG', 'triglyceride', 'Changes in Cu']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C0013340', 'cui_str': 'Dydrogesterone'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1136013', 'cui_str': 'Conjugated Equine Estrogens'}, {'cui': 'C0046018', 'cui_str': 'CEES'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0279494'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0312446', 'cui_str': 'Somatotropin binding globulin (substance)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0373587', 'cui_str': 'Copper measurement (procedure)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0578543', 'cui_str': 'Low density lipoprotein subfraction (substance)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0016693', 'cui_str': 'Free Radicals'}, {'cui': 'C0033268'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",45.0,0.0947277,Plasma concentrations of SHBG increased in the 3 groups.,"[{'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Nii', 'Affiliation': 'Department of Obstetrics and Gynecology, Aichi Medical University School of Medicine.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Shinohara', 'Affiliation': ''}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Matsushita', 'Affiliation': ''}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Noguchi', 'Affiliation': ''}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': ''}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Wakatsuki', 'Affiliation': ''}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.33175']
931,31562797,Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma.,"BACKGROUND


Nivolumab plus ipilimumab or nivolumab alone resulted in longer progression-free and overall survival than ipilimumab alone in a trial involving patients with advanced melanoma. We now report 5-year outcomes in the trial.
METHODS


We randomly assigned patients with previously untreated advanced melanoma to receive one of the following regimens: nivolumab (at a dose of 1 mg per kilogram of body weight) plus ipilimumab (3 mg per kilogram) every 3 weeks for four doses, followed by nivolumab (3 mg per kilogram every 2 weeks); nivolumab (3 mg per kilogram every 2 weeks) plus ipilimumab-matched placebo; or ipilimumab (3 mg per kilogram every 3 weeks for four doses) plus nivolumab-matched placebo. The two primary end points were progression-free survival and overall survival in the nivolumab-plus-ipilimumab group and in the nivolumab group, as compared with the ipilimumab group.
RESULTS


At a minimum follow-up of 60 months, the median overall survival was more than 60.0 months (median not reached) in the nivolumab-plus-ipilimumab group and 36.9 months in the nivolumab group, as compared with 19.9 months in the ipilimumab group (hazard ratio for death with nivolumab plus ipilimumab vs. ipilimumab, 0.52; hazard ratio for death with nivolumab vs. ipilimumab, 0.63). Overall survival at 5 years was 52% in the nivolumab-plus-ipilimumab group and 44% in the nivolumab group, as compared with 26% in the ipilimumab group. No sustained deterioration of health-related quality of life was observed during or after treatment with nivolumab plus ipilimumab or with nivolumab alone. No new late toxic effects were noted.
CONCLUSIONS


Among patients with advanced melanoma, sustained long-term overall survival at 5 years was observed in a greater percentage of patients who received nivolumab plus ipilimumab or nivolumab alone than in those who received ipilimumab alone, with no apparent loss of quality of life in the patients who received regimens containing nivolumab. (Funded by Bristol-Myers Squibb and others; CheckMate 067 ClinicalTrials.gov number, NCT01844505.).",2019,No sustained deterioration of health-related quality of life was observed during or after treatment with nivolumab plus ipilimumab or with nivolumab alone.,"['Advanced Melanoma', 'patients with advanced melanoma']","['Combined Nivolumab and Ipilimumab', 'ipilimumab-matched placebo; or ipilimumab', 'nivolumab-matched placebo', 'nivolumab-plus-ipilimumab', 'ipilimumab', 'nivolumab']","['Overall survival', 'longer progression-free and overall survival', 'quality of life', 'new late toxic effects', 'median overall survival', 'sustained long-term overall survival', 'progression-free survival and overall survival', 'sustained deterioration of health-related quality of life']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",,0.538325,No sustained deterioration of health-related quality of life was observed during or after treatment with nivolumab plus ipilimumab or with nivolumab alone.,"[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Chiarion-Sileni', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Gonzalez', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Lao', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'C Lance', 'Initials': 'CL', 'LastName': 'Cowey', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wagstaff', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Pier F', 'Initials': 'PF', 'LastName': 'Ferrucci', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Smylie', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hogg', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Márquez-Rodas', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Haanen', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Guidoboni', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Maio', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Céleste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'McArthur', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Daniels', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Jasmine I', 'Initials': 'JI', 'LastName': 'Rizzo', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Balogh', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Andriy', 'Initials': 'A', 'LastName': 'Moshyk', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'F Stephen', 'Initials': 'FS', 'LastName': 'Hodi', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}, {'ForeName': 'Jedd D', 'Initials': 'JD', 'LastName': 'Wolchok', 'Affiliation': ""From the Royal Marsden NHS Foundation Trust, London (J.L.), and the College of Medicine, Swansea University, Swansea (J.W.) - both in the United Kingdom; the Oncology Institute of Veneto IRCCS, Padua (V.C.-S.), the European Institute of Oncology, IRCCS, Milan (P.F.F.), Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples (P.A.A.), the Immunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola (M.G.), and the Center for Immuno-Oncology, Medical Oncology and Immunotherapy, University Hospital, Siena (M.M.) - all in Italy; the University of Colorado Cancer Center, Aurora (R.G.); Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille Hôpital Timone, Marseille (J.-J.G.), and Université de Paris, INSERM Unité 976, Assistance Publique-Hôpitaux de Paris Dermatology and Centres d'Investigation Clinique, Saint Louis Hospital, Paris (C.L.) - both in France; the Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland (P.R.); the University of Michigan, Ann Arbor (C.D.L.); Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas (C.L.C.); the Department of Dermatology, University of Essen, Essen, and the German Cancer Consortium, Heidelberg - both in Germany (D.S.); Universitäts Spital, Zurich, Switzerland (R.D.); Cross Cancer Institute, Edmonton, AB (M.S.), and the Princess Margaret Cancer Centre, Toronto (D.H.) - both in Canada; Tasman Oncology Research, Southport, QLD (A.H.), the Crown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, NSW (M.S.C., G.V.L.), and the Royal North Shore and Mater Hospitals (G.V.L.), Sydney, and the Peter MacCallum Cancer Centre, Melbourne, VIC (G.M.) - all in Australia; General University Hospital Gregorio Marañon and Centro de Investigación Biomédica en Red de Oncología, Madrid (I.M.-R.); the Netherlands Cancer Institute, Amsterdam (J.H.); the Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Leuven, Leuven, Belgium (P.S.); University of California San Diego Health-La Jolla Moores Cancer Center, La Jolla (G.A.D.); the Department of Oncology, Odense University Hospital, Odense, Denmark (L.B.); Bristol-Myers Squibb, Princeton, NJ (J.I.R., A.B., A.M.); Dana-Farber Cancer Institute, Boston (F.S.H.); and the Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York (J.D.W.).""}]",The New England journal of medicine,['10.1056/NEJMoa1910836']
932,26961111,Impact of Total Risk Management on Coronary Plaque Regression in Diabetic Patients with Acute Coronary Syndrome.,"AIM


Diabetic patients with coronary artery disease have a high incidence of cardiovascular events, which was associated with increased coronary plaque volume. Low-density lipoprotein cholesterol (LDL-C) and blood pressure (BP) play pivotal roles in the progression of coronary plaque. Several trials have shown that intervention for a single risk factor reduced the development of coronary plaque progression. However, it remained uncertain whether total risk management for LDL-C, BP, and glycosylated Hb (HbA1c) has a beneficial effect on coronary plaque volume in diabetic patients.
METHODS


This study was a sub-study of the JAPAN-ACS that was a prospective, randomized, open-label trial that evaluated the impact of intensive lipid-lowering therapy on coronary plaque volume in patients with acute coronary syndrome (ACS). Among a total of 252 patients, 73 diabetic patients were analyzed. We examined the impact of total risk management (LDL-C ＜80 mg/dL, systolic BP ＜130 mmHg, and HbA1c ＜6.5%) on changes in coronary plaque volume. The patients were divided into four groups according to the number of risk factors that achieved the target value.
RESULTS


Baseline characteristics were similar among the groups. The degree of coronary plaque regression was greater in patients who achieved total risk management. The number of risk factors that achieved the target level was associated with the extent of the coronary plaque volume reduction in a dose-dependent manner.
CONCLUSION


Total risk management that focused on LDL-C, BP, and HbA1c had a beneficial impact on the coronary plaque regression in diabetic patients with ACS.",2016,"The number of risk factors that achieved the target level was associated with the extent of the coronary plaque volume reduction in a dose-dependent manner.
","['252 patients, 73 diabetic patients', 'diabetic patients', 'Diabetic patients with coronary artery disease', 'diabetic patients with ACS', 'Diabetic Patients with Acute Coronary Syndrome', 'patients with acute coronary syndrome (ACS']","['Total Risk Management', 'intensive lipid-lowering therapy', 'total risk management (LDL-C ＜80 mg/dL, systolic BP ＜130 mmHg, and HbA1c ＜6.5']","['Coronary Plaque Regression', 'degree of coronary plaque regression', 'coronary plaque progression', 'coronary plaque volume', 'Low-density lipoprotein cholesterol (LDL-C) and blood pressure (BP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0035649', 'cui_str': 'Risk Management'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",252.0,0.0233836,"The number of risk factors that achieved the target level was associated with the extent of the coronary plaque volume reduction in a dose-dependent manner.
","[{'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Naito', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University School of Medicine.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Miyauchi', 'Affiliation': ''}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Daida', 'Affiliation': ''}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': ''}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Hiro', 'Affiliation': ''}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': ''}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Nakagawa', 'Affiliation': ''}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Yamagishi', 'Affiliation': ''}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Ozaki', 'Affiliation': ''}, {'ForeName': 'Masunori', 'Initials': 'M', 'LastName': 'Matsuzaki', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.31948']
933,26961114,Rationale and Design of the Standard Versus Intensive Statin Therapy for Hypercholesterolemic Patients with Diabetic Retinopathy (EMPATHY) Study: a Randomized Controlled Trial.,"AIM


Hyperlipidemia and diabetic retinopathy increase the risk of cardiovascular disease (CVD). The standard versus intEnsive statin therapy for hypercholesteroleMic Patients with diAbetic retinopaTHY (EMPATHY) study examines whether intensive lipid-lowering therapy is superior to standard therapy in reducing the incidence of cardiovascular events in patients with hyperlipidemia and diabetic retinopathy, but without a history of coronary artery disease.
METHODS


Patients who had elevated low-density lipoprotein cholesterol (LDL-C) and diabetic retinopathy without a history of coronary artery disease were eligible for the study. Patients were randomly assigned in a 1:1 ratio to receive intensive or standard therapy. Patients are being treated with monotherapy with 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor (statin) for a maximum of 5.5 years to achieve the following LDL-C target: ＜70 mg/dL for the intensive therapy group or ≥100 and ＜120 mg/dL for the standard therapy group. The primary endpoint is a composite of incidence of CVD and death from CVD.
RESULTS


Between May 2010 and October 2013, 5,995 patients were assessed for eligibility, and 5,144 were assigned to the study treatment (2,571 and 2,573 in the intensive and standard therapy groups, respectively), and baseline data were analyzed from 5,107 (2,550 in the intensive therapy group and 2,557 in the standard therapy group).
CONCLUSIONS


This is the first study assessing the benefits of intensive statin therapy in patients with hypercholesterolemia and diabetic retinopathy in a primary prevention setting. Furthermore, this study evaluates the appropriateness of the treat-to-target approach because all patients are treated to achieve specific LDL-C targets by titrating statin therapy.
CLINICAL TRIAL REGISTRATION NUMBER


UMIN000003486.",2016,"The standard versus intEnsive statin therapy for hypercholesteroleMic Patients with diAbetic retinopaTHY (EMPATHY) study examines whether intensive lipid-lowering therapy is superior to standard therapy in reducing the incidence of cardiovascular events in patients with hyperlipidemia and diabetic retinopathy, but without a history of coronary artery disease.
","['Hypercholesterolemic Patients with Diabetic Retinopathy (EMPATHY) Study', 'hypercholesteroleMic Patients with diAbetic retinopaTHY (EMPATHY', 'Patients who had elevated low-density lipoprotein cholesterol (LDL-C) and diabetic retinopathy without a history of coronary artery disease were eligible for the study', 'patients with hypercholesterolemia and diabetic retinopathy in a primary prevention setting', 'Between May 2010 and October 2013, 5,995 patients were assessed for eligibility, and 5,144 were assigned to the study treatment (2,571 and 2,573 in the intensive and standard therapy groups, respectively), and baseline data were analyzed from 5,107 (2,550 in the intensive therapy group and 2,557 in the standard therapy group', 'patients with hyperlipidemia and diabetic retinopathy, but without a history of coronary artery disease']","['intensive or standard therapy', 'Intensive Statin Therapy', '3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor (statin', 'intEnsive statin therapy', 'intensive statin therapy', 'intensive lipid-lowering therapy']","['composite of incidence of CVD and death from CVD', 'risk of cardiovascular disease (CVD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0033144', 'cui_str': 'Disease Prevention, Primary'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C4521898', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy (procedure)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}]",5995.0,0.0759836,"The standard versus intEnsive statin therapy for hypercholesteroleMic Patients with diAbetic retinopaTHY (EMPATHY) study examines whether intensive lipid-lowering therapy is superior to standard therapy in reducing the incidence of cardiovascular events in patients with hyperlipidemia and diabetic retinopathy, but without a history of coronary artery disease.
","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ueshima', 'Affiliation': 'Department of EBM Research, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': ''}, {'ForeName': 'Nobuaki', 'Initials': 'N', 'LastName': 'Kanazawa', 'Affiliation': ''}, {'ForeName': 'Issei', 'Initials': 'I', 'LastName': 'Komuro', 'Affiliation': ''}, {'ForeName': 'Ryozo', 'Initials': 'R', 'LastName': 'Nagai', 'Affiliation': ''}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Takeuchi', 'Affiliation': ''}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Yamazaki', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.33563']
934,26923252,The Relationship between Very High Levels of Serum High-Density Lipoprotein Cholesterol and Cause-Specific Mortality in a 20-Year Follow-Up Study of Japanese General Population.,"AIMS


There is no community-based cohort study to examine the effect of very high level of high-density lipoprotein cholesterol (HDL-C) on coronary heart disease (CHD) and other cause-specific mortality. Therefore, we investigated the relationship between HDL-C including very high level and cause-specific mortality in a 20-year cohort study of the representative sample of Japanese.
METHODS


We followed 7,019 individuals from the Japanese general population (2,946 men and 4,073 women). We defined HDL-C levels as follow: low (HDL-C ＜1.04 mmol/L), reference (1.04-1.55 mmol/L), high (1.56-2.06 mmol/L), very high (≥2.07 mmol/L). The multivariate adjusted hazard ratio (HR) for all-cause or cause-specific mortality was calculated using a Cox proportional hazards model adjusted for other traditional risk factors.
RESULTS


During follow-up, we observed 1,598 deaths. No significant association was observed between HDL-C and all-cause mortality. Serum HDL-C also showed no association with stroke. In contrast, the risk for CHD among high HDL-C was lower than reference, HRs were 0.51 [95% confidence interval (CI): 0.21-1.23] in men, 0.33 (95% CI: 0.11-0.95) in women, and 0.41 (95% CI: 0.21-0.81) when men and women were combined. However, very high HDL-C did not show significant association with CHD and other cause-specific mortality.
CONCLUSIONS


HDL-C was not associated with all-cause and stroke mortality. In contrast, high serum HDL-C levels, at least up to 2.06 mmol/L, were protective against CHD, although further high levels were not. However, sample size of cause-specific death in very high HDL-C group was not enough even in this 20-year follow-up of 7,019 Japanese; larger cohort studies should be warranted.",2016,No significant association was observed between HDL-C and all-cause mortality.,"['20-year cohort study of the representative sample of Japanese', '7,019 individuals from the Japanese general population (2,946 men and 4,073 women', 'Japanese General Population']",[],"['Serum High-Density Lipoprotein Cholesterol and Cause-Specific Mortality', 'Serum HDL-C', 'HDL-C levels', 'HDL-C and all-cause mortality', 'high serum HDL-C levels']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",7019.0,0.0640906,No significant association was observed between HDL-C and all-cause mortality.,"[{'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Hirata', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Okamura', 'Affiliation': ''}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sugiyama', 'Affiliation': ''}, {'ForeName': 'Kazuyo', 'Initials': 'K', 'LastName': 'Kuwabara', 'Affiliation': ''}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Kadota', 'Affiliation': ''}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Fujiyoshi', 'Affiliation': ''}, {'ForeName': 'Katsuyuki', 'Initials': 'K', 'LastName': 'Miura', 'Affiliation': ''}, {'ForeName': 'Nagako', 'Initials': 'N', 'LastName': 'Okuda', 'Affiliation': ''}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Ohkubo', 'Affiliation': ''}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Okayama', 'Affiliation': ''}, {'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Ueshima', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.33449']
935,26803913,Rationale and Design of the PROSPECTIVE Trial: Probucol Trial for Secondary Prevention of Atherosclerotic Events in Patients with Prior Coronary Heart Disease.,"BACKGROUND


Reduction of serum LDL-cholesterol by statins was shown to improve clinical outcomes in patients with coronary heart disease (CHD). Although intensive statin therapy significantly reduced cardiovascular risks, atherosclerotic cardiovascular events have not been completely prevented. Therefore, effective pharmacologic therapy is necessary to improve ""residual risks"" in combination with statins. Probucol has a potent antioxidative effect, inhibits the oxidation of LDL, and reduces xanthomas. Probucol Trial for Secondary Prevention of Atherosclerotic Events in Patients with Prior Coronary Heart Disease (PROSPECTIVE) is a multicenter, randomized, prospective study designed to test the hypothesis that the addition of probucol to other lipid-lowering drugs will prevent cerebro- and cardiovascular events in patients with prior coronary events and high LDL cholesterol levels.
STUDY DESIGN


The study will recruit approximately 860 patients with a prior CHD and dyslipidemia with LDL-C level ≥140 mg/dl without any medication and those treated with any lipid-lowering drugs with LDL-C level ≥100 mg/dl. Lipid-lowering agents are continuously administered during the study period in control group, and probucol (500 mg/day, 250 mg twice daily) is added to lipid-lowering therapy in the test group. The efficacy and safety of probucol with regard to the prevention of cerebro- and cardiovascular events and the intima-media thickness of carotid arteries as a surrogate marker will be evaluated.
SUMMARY


PROSPECTIVE will determine whether the addition of probucol to other lipid-lowering drugs improves cerebro- and cardiovascular outcomes in patients with prior coronary heart disease. Furthermore, the safety of a long-term treatment with probucol will be clarified.",2016,"The efficacy and safety of probucol with regard to the prevention of cerebro- and cardiovascular events and the intima-media thickness of carotid arteries as a surrogate marker will be evaluated.
","['patients with prior coronary heart disease', 'patients with coronary heart disease (CHD', 'Patients with Prior Coronary Heart Disease', '860 patients with a prior CHD and dyslipidemia with LDL-C level ≥140 mg/dl without any medication and those treated with any', 'patients with prior coronary events and high LDL cholesterol levels']","['probucol', 'lipid-lowering drugs', 'lipid-lowering drugs with LDL-C level ≥100 mg/dl', 'Probucol']","['efficacy and safety', 'Atherosclerotic Events', 'cerebro- and cardiovascular outcomes', 'cardiovascular risks, atherosclerotic cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]","[{'cui': 'C0033215', 'cui_str': 'Probucol'}, {'cui': 'C0086440', 'cui_str': 'Antilipemic Agents'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",860.0,0.0369979,"The efficacy and safety of probucol with regard to the prevention of cerebro- and cardiovascular events and the intima-media thickness of carotid arteries as a surrogate marker will be evaluated.
","[{'ForeName': 'Shizuya', 'Initials': 'S', 'LastName': 'Yamashita', 'Affiliation': 'Department of Community Medicine, Osaka University Graduate School of Medicine.'}, {'ForeName': 'Daisaku', 'Initials': 'D', 'LastName': 'Masuda', 'Affiliation': ''}, {'ForeName': 'Tohru', 'Initials': 'T', 'LastName': 'Ohama', 'Affiliation': ''}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Arai', 'Affiliation': ''}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Bujo', 'Affiliation': ''}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Kagimura', 'Affiliation': ''}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Kita', 'Affiliation': ''}, {'ForeName': 'Masunori', 'Initials': 'M', 'LastName': 'Matsuzaki', 'Affiliation': ''}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': ''}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Fukushima', 'Affiliation': ''}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Matsuzawa', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.32813']
936,26875519,Apolipoprotein E Epsilon 4 Enhances the Association between the rs2910164 Polymorphism of miR-146a and Risk of Atherosclerotic Cerebral Infarction.,"AIM


To analyse the relationship between two potentially functional single-nucleotide polymorphisms (SNPs) of the miR-146a gene (rs2910164 and rs57095329) and the risk of atherosclerotic cerebral infarction (ACI).
METHODS


A total of 297 patients with ACI and 300 matched healthy individuals were enrolled in the study. The miR-146a polymorphism was detected using the polymerase chain reaction-restriction fragment length polymorphism method.
RESULTS


A significant difference in the C allele frequency at rs2910164 (p=0.028) was noted between patients with ACI and control subjects. In contrast, the genotype and allele frequencies of rs57095329 were not statistically associated with ACI. In addition, the decreased expression of miR-146a was significantly more frequent in ACI patients who were ApoEε4 (＋) carriers (p=0.0233), and rs2910164 G＞C was intimately associated with the ApoEε4-containing genotype in patients compared with the ApoEε4 (－) carriers (p=0.0323).
CONCLUSIONS


Our findings indicated that the C allele of rs2910164 miR-146a is an important risk factor for ACI, and ApoEε4 may function through attenuating miR-146a expression to enhance ACI susceptibility. This study provides new information about the possible relationship between miR-146a and ApoEε4 in the development of ACI, with potentially important therapeutic implications.",2016,A significant difference in the C allele frequency at rs2910164 (p=0.028) was noted between patients with ACI and control subjects.,['297 patients with ACI and 300 matched healthy individuals were enrolled in the study'],[],"['expression of miR-146a', 'C allele frequency']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0540404', 'cui_str': 'adenylyl cyclase type I'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],"[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0017270', 'cui_str': 'Allele Frequency'}]",297.0,0.0350116,A significant difference in the C allele frequency at rs2910164 (p=0.028) was noted between patients with ACI and control subjects.,"[{'ForeName': 'Huidong', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Department of Neurosurgery, Affiliated second Hospital, Guangdong Medical University.'}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Junfen', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'De', 'Initials': 'D', 'LastName': 'Cai', 'Affiliation': ''}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Chengbiao', 'Initials': 'C', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'Kaiyu', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Panghe', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Jinrong', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': ''}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.32904']
937,32419092,Image quality and radiation dose of different scanning protocols in DSCT cardiothoracic angiography for children with tetralogy of fallot.,"The aim of this study was to investigate the image quality and radiation dose of different scanning protocols in dual-source CT cardiothoracic angiography for children with tetralogy of Fallot (TOF). Seventy-five consecutive children with known or suspected TOF were enrolled to undergo prospective ECG-triggering sequential dual-source CT (DSCT) cardiothoracic angiography. According to the scanning protocols, these patients were randomly divided into 3 groups: fixed delay time (FDT, n = 25, group A), automatic bolus-tracking (ABT, n = 25, group B) and manual bolus-tracking (MBT, n = 25, group C). Subjective and objective image quality were evaluated. The radiation doses were recorded. The image quality scores of group C were significantly higher than those of group A and B. The absolute value of difference (D-value) on CT attenuation between left (CT LV ) and right ventricle (CT RV ) in group C was significantly lower than that in group A and B. The total effective dose of groups A, B and C were 0.39 ± 0.06 mSv, 0.40 ± 0.07 mSv and 0.40 ± 0.08 mSv, respectively. There was no significant difference among 3 groups (P = 0.722). Scanning protocol has significantly impacts on the image quality of cardiovascular structures for TOF patients. Compared with the conventional scanning protocols FDT and ABT, the MBT technique provides high image quality and achieves more homogenous attenuation among different patients with TOF.",2020,The image quality scores of group C were significantly higher than those of group A and B.,"['children with tetralogy of fallot', 'children with tetralogy of Fallot (TOF', 'TOF patients', 'Seventy-five consecutive children with known or suspected TOF were enrolled to undergo prospective']","['DSCT cardiothoracic angiography', 'scanning protocols in dual-source CT cardiothoracic angiography', 'ECG-triggering sequential dual-source CT (DSCT) cardiothoracic angiography', 'fixed delay time (FDT, n\u2009=\u200925, group A), automatic bolus-tracking (ABT, n\u2009=\u200925, group B) and manual bolus-tracking (MBT']","['Subjective and objective image quality', 'CT attenuation between left (CT LV ) and right ventricle (CT RV ', 'image quality scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0039685', 'cui_str': 'Tetralogy of Fallot'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0522486', 'cui_str': 'Delay time'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0045246', 'cui_str': ""2,2'-azino-di-(3-ethylbenzothiazoline)-6-sulfonic acid""}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0054631', 'cui_str': '2-MERCAPTOBENZOTHIAZOLE'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0225883', 'cui_str': 'Right cardiac ventricular structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",75.0,0.0167736,The image quality scores of group C were significantly higher than those of group A and B.,"[{'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Duan', 'Affiliation': ""Department of Medical Imaging, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, 210002, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Ultrasound, Shandong Provincial Hospital Affliated to Shandong First Medical University, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Radiology, Shandong Medical Imaging Research Institute, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Baoting', 'Initials': 'B', 'LastName': 'Chao', 'Affiliation': ""Department of Radiology, Shandong Medical Imaging Research Institute, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Zhaoping', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': ""Department of Radiology, Shandong Medical Imaging Research Institute, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': ""Department of Radiology, Shandong Medical Imaging Research Institute, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': ""Department of Radiology, Shandong Provincial Hospital Affliated to Shandong First Medical University, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Baojin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Department of Radiology, Shandong Provincial Hospital Affliated to Shandong First Medical University, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ""CT Scientific Collaboration, Siemens Healthcare Limited, Beijing, 100102, People's Republic of China.""}, {'ForeName': 'Ximing', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Radiology, Shandong Provincial Hospital Affliated to Shandong First Medical University, Shandong University, No. 324 Jingwu Road, Jinan, 250021, People's Republic of China. wxming369@163.com.""}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Lu', 'Affiliation': ""Department of Medical Imaging, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, 210002, People's Republic of China. gmlu369@163.com.""}]",The international journal of cardiovascular imaging,['10.1007/s10554-020-01882-w']
938,32419688,Dietary intake and processes of behaviour change in a nutrition education intervention for pregnant women in rural Malawi: a cluster-randomised controlled trial.,"OBJECTIVE


To examine if increased intake of locally available nutrient-dense foods among pregnant women improved the quality of their dietary intake and if use of the Theory of Planned Behaviour could explain changes in their dietary behaviour.
DESIGN


We used data from a randomised controlled trial where the intervention group received nutrition education and dietary counselling. We promoted the use of recipes that utilised powders to enhance dietary diversity. We examined how the intervention achieved changes in dietary intakes and used mixed effects logistic regression models with random effects at village level to explore changes over time of the outcomes, adjusted for selected explanatory variables.
SETTING


The study was conducted in twenty villages in rural Malawi.
PARTICIPANTS


Data from 257 pregnant women who were enrolled during late first trimester and followed until birth.
RESULTS


The intervention achieved improvements in the Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods. A third of the women in the intervention group attained optimal DDS, whereas about 50 % attained optimal SFG. The theorised behaviour mediators (i.e. nutrition attitudes, nutrition behaviour control and subjective norm) that had improved were also significantly associated with high DDS.
CONCLUSIONS


Improved dietary intakes were achieved through promoting the use of locally available nutrient-dense foods. Attainment of high DDS was a consequence of the women's belief in the effectiveness of the proposed nutrition recommendations. We identified critical personal and environmental constraints related to dietary intakes during pregnancy in a low-resource setting.",2020,"The intervention achieved improvements in the Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods.","['twenty villages in rural Malawi', 'Data from 257 pregnant women who were enrolled during late first trimester and followed until birth', 'pregnant women in rural Malawi', 'pregnant women']","['nutrition education and dietary counselling', 'nutrition education intervention']","['Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods', 'optimal DDS']","[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032979', 'cui_str': 'First trimester pregnancy'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034229', 'cui_str': 'Pyramidal tract structure'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0453861', 'cui_str': 'Rich food'}]",257.0,0.0758828,"The intervention achieved improvements in the Dietary Diversity Score (DDS) and the Six Food Group Pyramid (SFG) score, especially in intakes of micronutrient-rich foods.","[{'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Ziyenda Katenga-Kaunda', 'Affiliation': 'Department of Nutrition, University of Oslo, PO Box 1046 Blindern, 0316Oslo, Norway.'}, {'ForeName': 'Per Ole', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Nutrition, University of Oslo, PO Box 1046 Blindern, 0316Oslo, Norway.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Holmboe-Ottesen', 'Affiliation': 'Department of Community Medicine and Global Health, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Fjeld', 'Affiliation': 'Department of Community Medicine and Global Health, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ibrahimu', 'Initials': 'I', 'LastName': 'Mdala', 'Affiliation': 'Department of Community Medicine and Global Health, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Penjani Rhoda', 'Initials': 'PR', 'LastName': 'Kamudoni', 'Affiliation': 'Department of Nutrition, University of Oslo, PO Box 1046 Blindern, 0316Oslo, Norway.'}]",Public health nutrition,['10.1017/S1368980020000294']
939,31556212,Application of ICD-11 among individuals with chronic pain: A post hoc analysis of the Stanford Self-Management Program.,"BACKGROUND


Chronic primary pain (CPP) is one of seven diagnostic groups within the proposed classification of chronic pain in ICD-11. Our aims were to apply the proposed ICD-11 criteria in a large cohort of chronic pain patients participating in the Chronic Pain Self-Management Program (CPSMP) and further investigate whether participants with CPP differed from participants with chronic secondary pain (CSP) regarding health, health expenditure and the effect of participating in the CPSMP.
METHODS


A secondary analysis of a randomized, controlled trial on the effect of the CPSMP. Four examiners categorized participants' pain according to ICD-11 using register-based medical diagnoses and patients' self-reported symptoms. Afterwards, differences between CPP and CSP were examined.
RESULTS


Out of 394 participants, 312 were successfully classified into CPP (n = 164) or CSP (n = 148) whereas 76 had a mixed pain condition. Participants with CPP were younger, more likely to be women, and had longer pain duration compared to participants with CSP. Participants with CPP reported worse health-related quality of life on the SF-36 Mental Component Summary and subscales of vitality, social functioning and bodily pain. Participants with CSP had more physical comorbidities and higher total health expenditure. None of the groups benefitted from the CPSMP.
CONCLUSIONS


We successfully applied the new classification of chronic pain in ICD-11 on the basis of ICD-10 medical diagnoses and symptom self-report. Participants with CPP differed significantly from participants with CSP on baseline characteristics, self-reported health measures and total health expenditure. The CPSMP was not effective in any of the groups.
SIGNIFICANCE


The current study applies the proposed new classification of chronic pain in ICD-11 and shares the experiences of the diagnostic rating procedure of individuals with chronic pain. Furthermore, it evaluates the effect of the Stanford Self-Management Program.",2020,"Participants with CPP reported worse health-related quality of life on the SF-36 Mental Component Summary and subscales of vitality, social functioning and bodily pain.","['individuals with chronic pain', 'Chronic primary pain (CPP', 'chronic pain patients participating in the Chronic Pain Self-Management Program (CPSMP) and further investigate whether participants with CPP differed from participants with chronic secondary pain (CSP) regarding health, health expenditure and the effect of participating in the CPSMP', '394 participants, 312 were successfully classified into CPP (n\xa0=\xa0164) or CSP (n\xa0=\xa0148) whereas 76 had a mixed pain condition']","['ICD-11', 'CPSMP']","['worse health-related quality of life on the SF-36 Mental Component Summary and subscales of vitality, social functioning and bodily pain', 'baseline characteristics, self-reported health measures and total health expenditure', 'longer pain duration', 'physical comorbidities and higher total health expenditure']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0047123', 'cui_str': 'CPP'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0015318', 'cui_str': 'Health Expenditures'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C4704940', 'cui_str': 'ICD-11'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015318', 'cui_str': 'Health Expenditures'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",394.0,0.097158,"Participants with CPP reported worse health-related quality of life on the SF-36 Mental Component Summary and subscales of vitality, social functioning and bodily pain.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Hornemann', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus C, Denmark.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schröder', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus C, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ørnbøl', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus C, Denmark.'}, {'ForeName': 'Nils Balle', 'Initials': 'NB', 'LastName': 'Christensen', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus C, Denmark.'}, {'ForeName': 'Marian Dalgaard', 'Initials': 'MD', 'LastName': 'Høeg', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus C, Denmark.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Mehlsen', 'Affiliation': 'The Department of Psychology and Behavioural Science, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Frostholm', 'Affiliation': 'The Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus C, Denmark.'}]","European journal of pain (London, England)",['10.1002/ejp.1486']
940,31560051,Effectiveness of Oral Vancomycin for Prevention of Healthcare Facility-Onset Clostridioides difficile Infection in Targeted Patients During Systemic Antibiotic Exposure.,"BACKGROUND


Limited retrospective data suggest prophylactic oral vancomycin may prevent Clostridioides difficile infection (CDI). We sought to evaluate the effectiveness of oral vancomycin for the prevention of healthcare facility-onset CDI (HCFO-CDI) in targeted patients.
METHODS


We conducted a randomized, prospective, open-label study at Novant Health Forsyth Medical Center in Winston-Salem, North Carolina, between October 2018 and April 2019. Included patients were randomized 1:1 to either oral vancomycin (dosed at 125 mg once daily while receiving systemic antibiotics and continued for 5 days postcompletion of systemic antibiotics [OVP]) or no prophylaxis. The primary endpoint was incidence of HCFO-CDI. Secondary endpoints included incidence of community-onset healthcare facility-associated CDI (CO-HCFA-CDI), incidence of vancomycin-resistant Enterococci (VRE) colonization after receiving OVP, adverse effects, and cost of OVP.
RESULTS


A total of 100 patients were evaluated, 50 patients in each arm. Baseline and hospitalization characteristics were similar, except antibiotic exposure. No events of HCFO-CDI were noted in the OVP group compared with 6 (12%) in the no-prophylaxis group (P = .03). CO-HCFA-CDI was identified in 2 patients who were previously diagnosed with HCFO-CDI. No patients developed new VRE colonization, with only 1 patient reporting mild gastrointestinal side effects to OVP. A total of 600 doses of OVP were given during the study, with each patient receiving an average of 12 doses. Total acquisition cost of OVP was $1302, $26.04 per patient.
CONCLUSION


OVP appears to protect against HCFO-CDI during in-patient stay in targeted patients during systemic antibiotic exposure. Further prospective investigation is warranted.",2020,No events of HCFO-CDI were noted in the OVP group compared to 6 (12%) in the no prophylaxis group (p = 0.03).,"['Novant Health Forsyth Medical Center in Winston-Salem, North Carolina between October 2018 and April 2019', 'targeted patients', 'A total of 100 patients were evaluated, 50 patients in each arm', '2 patients who were previously diagnosed with HCFO-CDI', 'Targeted Patients']","['OVP', 'vancomycin', 'Oral Vancomycin', 'oral vancomycin', 'systemic antibiotics [OVP]), or no prophylaxis']","['new VRE colonization', 'HCFO-CDI', 'Baseline and hospitalization characteristics', 'incidence of HCFO-CDI', 'Total acquisition cost of OVP', 'incidence of community-onset healthcare facility-associated CDI (CO-HCFA-CDI), incidence of vancomycin-resistant Enterococci (VRE) colonization after receiving OVP, adverse effects and cost of OVP', 'CO-HCFA-CDI']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0041718', 'cui_str': 'Health Care Financing Administration'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",100.0,0.103606,No events of HCFO-CDI were noted in the OVP group compared to 6 (12%) in the no prophylaxis group (p = 0.03).,"[{'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Johnson', 'Affiliation': 'Department of Pharmacy Practice, Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina, USA.'}, {'ForeName': 'Shannon V', 'Initials': 'SV', 'LastName': 'Brown', 'Affiliation': 'Department of Pharmacy Practice, Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Priest', 'Affiliation': 'Novant Health Institute for Safety and Quality, Winston-Salem, North Carolina, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz966']
941,32091610,"Use of a Digital Cognitive Aid in the Early Management of Simulated War Wounds in a Combat Environment, a Randomized Trial.","INTRODUCTION


The French army has implemented an algorithm based on the acronym ""MARCHE RYAN,"" each letter standing for a key action to complete in order to help first care providers during emergency casualty care. On the battlefield, the risk of error is increased, and the use of cognitive aids (CAs) might be helpful to avoid distraction. We investigated the effect of using a digital CA (MAX, for Medical Assistance eXpert) by combat casualty care providers on their technical and nontechnical performances during the early management of simulated war wounds, compared to their memory and training alone.
MATERIALS AND METHODS


We conducted a randomized, controlled, unblinded study between July 2016 and February 2017. This study was approved by the Ethics Committee of the Ethical Board of Desgenettes Army Training Hospital (14.06.2017 n°385) and was registered on clinicaltrials.gov (NCT03483727). It took place during medicalization training in hostile environment (""MEDICHOS"") in Chamonix Mont-Blanc and in the first aid training center in La Valbonne military base (France). Each participant had to deal with two different scenarios, one with MAX (MAX+) and the other without (MAX-). Scenarios were held using either high-fidelity patient simulators or actors as wounded patients. The primary outcome was participants' technical performance rated as their adherence to the MARCHE RYAN procedure (maximum 100%). The secondary outcome was the nontechnical performance according to the Ottawa crisis resource management Global Rating Scale (maximum 42).
RESULTS


Technical performance was significantly higher in the MAX+ scenarios (70.60 IQR [63.70-73.56] than in the MAX- scenarios (56.25 IQR [52.88-62.09], p = 0.002). The Ottawa scores were significantly higher in the MAX+ scenarios (31.50 IQR [29.50-33.75]) than in the MAX- scenarios (29.50 IQR [24.50-32.00], p = 0.031).
CONCLUSIONS


The use of a digital CA by combat casualty care providers improved technical and nontechnical performances during field training of simulated crises. Following recommendations on the design and use of CA, regular team training would improve fluidity in the use and acceptance of an aid, by a highly drilled professional corporation with a strong culture of leadership. Digital CA should be tested at a larger scale in order to validate their contribution to real combat casualty care.",2020,The use of a digital CA by combat casualty care providers improved technical and nontechnical performances during field training of simulated crises.,['July 2016 and February 2017'],"['CA, regular team training', 'MAX (MAX+) and the other without (MAX', 'cognitive aids (CAs', 'digital CA (MAX, for Medical Assistance eXpert', 'Digital Cognitive Aid']","['nontechnical performance according to the Ottawa crisis resource management Global Rating Scale (maximum 42', 'Technical performance', 'technical performance rated as their adherence to the MARCHE RYAN procedure']",[],"[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0025070', 'cui_str': 'Medical Assistance'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}]","[{'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",,0.0500687,The use of a digital CA by combat casualty care providers improved technical and nontechnical performances during field training of simulated crises.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Truchot', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Balança', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}, {'ForeName': 'Pierre François', 'Initials': 'PF', 'LastName': 'Wey', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Tazarourte', 'Affiliation': 'Health Services and Performance Research EA74, Université Claude Bernard Lyon1, 43 Boulevard du 11 Novembre 1918, 69100 Villeurbanne, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lecomte', 'Affiliation': 'Emergency Department, Hôpital Cochin, 27 Rue du Faubourg Saint-Jacques, 75014 Paris, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Le Goff', 'Affiliation': 'Direction de la Médecine des Forces, Bureau Soutien des Activités Opérationnelles, BA 705 - RD 910, 37076 Tour Cedex 02, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Leigh-Smith', 'Affiliation': 'Royal Infirmary of Edinburgh, Emergency Department, 51 Little France Cres, Edinburgh EH16 4SA, Scotland.'}, {'ForeName': 'Jean Jacques', 'Initials': 'JJ', 'LastName': 'Lehot', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rimmele', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}, {'ForeName': 'Jean Christophe', 'Initials': 'JC', 'LastName': 'Cejka', 'Affiliation': ""Centre Lyonnais d'Enseignement par la Simulation en Santé, SAMSEI, Université Claude Bernard Lyon 1, 8 avenue Rockefeller- 69372 LYON CEDEX 08, Lyon, France.""}]",Military medicine,['10.1093/milmed/usz482']
942,32065967,Impact of Chlorhexidine Bathing on Antimicrobial Utilization in Surgical Intensive Care Unit.,"BACKGROUND


This secondary analysis compared antimicrobial utilization among surgical intensive care unit patients randomized to every other day chlorhexidine bathing (chlorhexidine) versus daily soap and water bathing (soap-and-water) using data from the CHlorhexidine Gluconate BATHing trial.
MATERIALS AND METHODS


Antimicrobial utilization was quantified using defined daily dose (DDD)/100 patient-days and agent-days/100 patient-days for systemic antimicrobials. Antivirals (except oseltamivir), antiparasitics, and prophylaxis agents were excluded. The 2018 anatomic therapeutic chemical/DDD index was used to calculate DDD. Agent-days were calculated as the sum of calendar days where antimicrobials were administered. Patient-days were defined as time patients were at risk for health care-acquired infections plus up to 14 d. Primary analyses were conducted using linear regression adjusted for baseline Acute Physiology and Chronic Health Evaluation II scores.
RESULTS


Of 325 CHlorhexidine Gluconate BATHing trial patients, 312 (157 in soap-and-water and 155 in chlorhexidine) were included. The median (interquartile range) of total antimicrobial DDD/100 patient-days was 135.4 (75.2-231.8) for soap-and-water and 129.9 (49.2-215.3) for chlorhexidine. The median (interquartile range) of total antimicrobial agent-days/100 patient-days was 155.6 (83.3-243.2) for soap-and-water and 146.7 (66.7-217.4) for chlorhexidine. After adjusting for Acute Physiology and Chronic Health Evaluation II scores, chlorhexidine bathing was associated with a nonsignificant reduction in total antimicrobial DDD/100 patient-days (-3.9; 95% confidence interval, -33.9 to 26.1; P = 0.80) and total antimicrobial agent-days/100 patient-days (-10.3; 95% confidence interval, -34.7 to 14.1; P = 0.41).
CONCLUSIONS


Compared with daily soap and water bathing, every other day chlorhexidine bathing did not significantly reduce total antimicrobial utilization in surgical intensive care unit patients.",2020,"Compared with daily soap and water bathing, every other day chlorhexidine bathing did not significantly reduce total antimicrobial utilization in surgical intensive care unit patients.","['surgical intensive care unit patients', 'Surgical Intensive Care Unit', 'trial patients, 312 (157 in soap-and-water and 155 in']","['chlorhexidine', 'chlorhexidine bathing (chlorhexidine', 'CHlorhexidine Gluconate', 'Chlorhexidine']","['Antimicrobial utilization', 'total antimicrobial utilization']","[{'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0043047', 'cui_str': 'Water'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0518460', 'cui_str': 'Bathing (observable entity)'}, {'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}]","[{'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0951131,"Compared with daily soap and water bathing, every other day chlorhexidine bathing did not significantly reduce total antimicrobial utilization in surgical intensive care unit patients.","[{'ForeName': 'Lan N', 'Initials': 'LN', 'LastName': 'Bui', 'Affiliation': 'Department of Pharmacy Practice, Samford University McWhorter School of Pharmacy, Birmingham, Alabama; Houston Methodist Research Institute, Houston, Texas.'}, {'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Swan', 'Affiliation': 'Houston Methodist Research Institute, Houston, Texas; Department of Pharmacy Services, Houston Methodist Hospital, Houston, Texas; Department of Surgery, Houston Methodist Hospital, Houston, Texas. Electronic address: swan.joshua@gmail.com.'}, {'ForeName': 'Katherine K', 'Initials': 'KK', 'LastName': 'Perez', 'Affiliation': 'Houston Methodist Research Institute, Houston, Texas; Department of Pharmacy Services, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'Department of Pharmaceutical Health Outcomes and Policy, University of Houston College of Pharmacy, Houston, Texas.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Pharmaceutical Health Outcomes and Policy, University of Houston College of Pharmacy, Houston, Texas.'}, {'ForeName': 'A Carmine', 'Initials': 'AC', 'LastName': 'Colavecchia', 'Affiliation': 'Department of Pharmacy Services, Houston Methodist Hospital, Houston, Texas.'}, {'ForeName': 'Elsie', 'Initials': 'E', 'LastName': 'Rizk', 'Affiliation': 'Houston Methodist Research Institute, Houston, Texas.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Graviss', 'Affiliation': 'Houston Methodist Research Institute, Houston, Texas.'}]",The Journal of surgical research,['10.1016/j.jss.2019.12.049']
943,27026388,The diabetes nutrition education study randomized controlled trial: A comparative effectiveness study of approaches to nutrition in diabetes self-management education.,"OBJECTIVE


To compare the effectiveness of different approaches to nutrition education in diabetes self-management education and support (DSME/S).
METHODS


We randomized 150 adults with type 2 diabetes to either certified diabetes educator (CDE)-delivered DSME/S with carbohydrate gram counting or the modified plate method versus general health education. The primary outcome was change in HbA1C over 6 months.
RESULTS


At 6 months, HbA1C improved within the plate method [-0.83% (-1.29, -0.33), P<0.001] and carbohydrate counting [-0.63% (-1.03, -0.18), P=0.04] groups but not the control group [P=0.34]. Change in HbA1C from baseline between the control and intervention groups was not significant at 6 months (carbohydrate counting, P=0.36; modified plate method, P=0.08). In a pre-specified subgroup analysis of patients with a baseline HbA1C 7-10%, change in HbA1C from baseline improved in the carbohydrate counting [-0.86% (-1.47, -0.26), P=0.006] and plate method groups [-0.76% (-1.33, -0.19), P=0.01] compared to controls.
CONCLUSION


CDE-delivered DSME/S focused on carbohydrate counting or the modified plate method improved glycemic control in patients with an initial HbA1C between 7 and 10%.
PRACTICE IMPLICATIONS


Both carbohydrate counting and the modified plate method improve glycemic control as part of DSME/S.",2016,"At 6 months, HbA1C improved within the plate method [-0.83% (-1.29, -0.33), P<0.001] and carbohydrate counting [-0.63% (-1.03, -0.18), P=0.04] groups but not the control group [P=0.34].","['150 adults with type 2 diabetes to either', 'diabetes self-management education', 'patients with an initial HbA1C between 7 and 10']",['certified diabetes educator (CDE)-delivered DSME/S with carbohydrate gram counting or the modified plate method versus general health education'],"['glycemic control', 'carbohydrate counting', 'change in HbA1C', 'Change in HbA1C', 'HbA1C']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018701'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1562940', 'cui_str': 'Carbohydrate counting'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",150.0,0.0858912,"At 6 months, HbA1C improved within the plate method [-0.83% (-1.29, -0.33), P<0.001] and carbohydrate counting [-0.63% (-1.03, -0.18), P=0.04] groups but not the control group [P=0.34].","[{'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Bowen', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA; Division of Outcomes and Health Services Research, Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Kerri L', 'Initials': 'KL', 'LastName': 'Cavanaugh', 'Affiliation': 'Division of Nephrology, Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA; Vanderbilt Diabetes Center, Vanderbilt University, School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Wolff', 'Affiliation': 'Vanderbilt Diabetes Center, Vanderbilt University, School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Davis', 'Affiliation': 'Vanderbilt Diabetes Center, Vanderbilt University, School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Rebecca P', 'Initials': 'RP', 'LastName': 'Gregory', 'Affiliation': 'Vanderbilt Diabetes Center, Vanderbilt University, School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Ayumi', 'Initials': 'A', 'LastName': 'Shintani', 'Affiliation': 'Department of Biostatistics, Vanderbilt University, School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Eden', 'Affiliation': 'Department of Biostatistics, Vanderbilt University, School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Wallston', 'Affiliation': 'School of Nursing, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Elasy', 'Affiliation': 'Division of General Internal Medicine and Public Health, Department of Medicine, Vanderbilt University, School of Medicine, Nashville, TN, USA; Vanderbilt Diabetes Center, Vanderbilt University, School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Rothman', 'Affiliation': 'Division of General Internal Medicine and Public Health, Department of Medicine, Vanderbilt University, School of Medicine, Nashville, TN, USA; Vanderbilt Diabetes Center, Vanderbilt University, School of Medicine, Nashville, TN, USA. Electronic address: russell.rothman@vanderbilt.edu.'}]",Patient education and counseling,['10.1016/j.pec.2016.03.017']
944,32416718,Experiences of integrating community volunteers as extensions of the primary care team to help support older adults at home: a qualitative study.,"BACKGROUND


Increasing the integration of community volunteers into primary health care delivery has the potential to improve person-focused, coordinated care, yet the use of volunteers in primary care is largely unexplored. Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) is a multi-component intervention involving trained community volunteers functioning as extensions of primary care teams, supporting care based on older adults' health goals and needs. This study aimed to gain an understanding of volunteer experiences within the program and client and health care provider perspectives on the volunteer role.
METHODS


This study used a qualitative descriptive approach embedded in a pragmatic randomized controlled trial. Participants included Health TAPESTRY volunteers, health care providers, volunteer coordinator, and program clients, all connected to two primary care practice sites in a large urban setting in Ontario, Canada. Data collection included semi-structured focus groups and interviews with all participants, and the completion of a measure of attitudes toward older adults and self-efficacy for volunteers. Qualitative data were inductively coded and analyzed using a constant comparative approach. Quantitative data were summarized using descriptive statistics.
RESULTS


Overall, 30 volunteers and 64 other participants (clients, providers, volunteer coordinator) were included. Themes included: 1. Volunteer training: ""An investment in volunteers""; 2. Intergenerational volunteer pairing: ""The best of both worlds""; 3. Understanding the volunteer role and its scope: ""Lay people involved in care""; 4. Volunteers as extensions of primary care teams: ""Being the eyes where they live""; 5. The disconnect between volunteers and the clinical team: ""Is something being done?""; 6. ""Learning… all the time"": Impacts on volunteers; and 7. Clients' acceptance of volunteers.
CONCLUSIONS


This study showed that it is possible to integrate community volunteers into the primary care setting, adding human connections to deepen the primary care team's understanding of their patients. Program implementation suggestions that emerged included: using role play in training, making volunteer role boundaries and specifications clear, and making efforts to connect volunteers and the primary care team they are supporting. This exploration of stakeholder voices has the potential to help improve volunteer program uptake and acceptability, as well as volunteer recruitment, retention, and training.
TRIAL REGISTRATION


For RCT: https://clinicaltrials.gov/ct2/show/NCT02283723, November 5, 2014.",2020,"Strengthening Quality (Health TAPESTRY) is a multi-component intervention involving trained community volunteers functioning as extensions of primary care teams, supporting care based on older adults' health goals and needs.","['30 volunteers and 64 other participants (clients, providers, volunteer coordinator) were included', 'Intergenerational volunteer pairing: ', 'older adults at home', 'Participants included Health TAPESTRY volunteers, health care providers, volunteer coordinator, and program clients, all connected to two primary care practice sites in a large urban setting in Ontario, Canada', 'Health Teams Advancing Patient Experience', ""volunteers; and 7. Clients' acceptance of volunteers""]","['Strengthening Quality (Health TAPESTRY', 'worlds']",[],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],30.0,0.0198048,"Strengthening Quality (Health TAPESTRY) is a multi-component intervention involving trained community volunteers functioning as extensions of primary care teams, supporting care based on older adults' health goals and needs.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gaber', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada. jgaber@mcmaster.ca.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Oliver', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Valaitis', 'Affiliation': 'School of Nursing, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cleghorn', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Larkin', 'Initials': 'L', 'LastName': 'Lamarche', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Ernie', 'Initials': 'E', 'LastName': 'Avilla', 'Affiliation': 'Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Parascandalo', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dolovich', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4K1, Canada.'}]",BMC family practice,['10.1186/s12875-020-01165-2']
945,26797266,Effects of Statin Therapy on Plasma Proprotein Convertase Subtilisin/kexin Type 9 and Sortilin Levels in Statin-Naive Patients with Coronary Artery Disease.,"AIM


Proprotein convertase subtilisin/kexin type 9 (PCSK9) is a key regulator of serum low-density lipoprotein (LDL) cholesterol levels, and sortilin is linked to lipoprotein metabolism. Although statin therapy increases PCSK9 levels, effects of this therapy on plasma sortilin levels have not been evaluated. The purpose of the present study was to examine the effects of statins on plasma PCSK9 and sortilin levels, and association of statin-induced increase in PCSK9 levels with sortilin.
METHODS


Serum lipid levels and plasma PCSK9 and sortilin levels were measured at baseline and 8 months after statin therapy in 90 statin-naive patients with coronary artery disease (CAD). Pitavastatin 4 mg/day was used to treat 44 patients and pravastatin 20 mg/day to treat the remaining 46 patients.
RESULTS


For both statin groups, significant increases in hetero-dimer PCSK9 levels (pitavastatin: 31%, p＜0.0001; pravastatin: 34%, p=0.03) and decreases in sortilin levels (pitavastatin: －8%, p=0.02; pravastatin: －16%, p=0.002) were observed. Although a reduction in LDL cholesterol was greater in the pitavastatin group than in the pravastatin group, no significant differences were observed in percentage changes in hetero-dimer PCSK9 and sortilin levels. A significant positive correlation was observed between percentage changes in hetero-dimer PCSK9 levels and those in sortilin levels (pitavastatin: r=0.359, p=0.02; pravastatin: r=0.276, p=0.06).
CONCLUSIONS


Use of pitavastatin and pravastatin increased plasma PCSK9 and decreased sortilin levels. Statin-induced increases in PCSK9 were associated with changes in sortilin in statin-naive patients with CAD.",2016,"A significant positive correlation was observed between percentage changes in hetero-dimer PCSK9 levels and those in sortilin levels (pitavastatin: r=0.359, p=0.02; pravastatin: r=0.276, p=0.06).
","['90 statin-naive patients with coronary artery disease (CAD', 'Statin-Naive Patients with Coronary Artery Disease']","['pitavastatin', 'Proprotein convertase subtilisin/kexin type 9 (PCSK9', 'Pitavastatin', 'pravastatin', 'Statin Therapy', 'pitavastatin and pravastatin']","['Plasma Proprotein Convertase Subtilisin/kexin Type 9 and Sortilin Levels', 'plasma PCSK9 and decreased sortilin levels', 'hetero-dimer PCSK9 and sortilin levels', 'PCSK9 levels', 'hetero-dimer PCSK9 levels', 'LDL cholesterol', 'Serum lipid levels and plasma PCSK9 and sortilin levels', 'plasma sortilin levels', 'sortilin levels', 'plasma PCSK9 and sortilin levels', 'PCSK9']","[{'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C1100660', 'cui_str': 'Proprotein Convertases'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'kexin protein, S cerevisiae'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1100660', 'cui_str': 'Proprotein Convertases'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'kexin protein, S cerevisiae'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0536670', 'cui_str': 'sortilin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1287373', 'cui_str': 'Finding of serum lipid levels (finding)'}]",,0.0349902,"A significant positive correlation was observed between percentage changes in hetero-dimer PCSK9 levels and those in sortilin levels (pitavastatin: r=0.359, p=0.02; pravastatin: r=0.276, p=0.06).
","[{'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Nozue', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Yokohama Sakae Kyosai Hospital.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Hattori', 'Affiliation': ''}, {'ForeName': 'Kazuyuki', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': ''}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kujiraoka', 'Affiliation': ''}, {'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Iwasaki', 'Affiliation': ''}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Michishita', 'Affiliation': ''}]",Journal of atherosclerosis and thrombosis,['10.5551/jat.33407']
946,31550352,Significantly Increased Patient Satisfaction Following Liquid Formulation AbobotulinumtoxinA Treatment in Glabellar Lines: FACE-Q Outcomes From a Phase 3 Clinical Trial.,"BACKGROUND


The FACE-Q patient-reported outcome assesses patient experiences/outcomes with aesthetic facial procedure. A recent trial of abobotulinumtoxinA (ASI, liquid formulation) was the first to our knowledge to assess satisfaction with FACE-Q after glabellar line (GL) injection.
OBJECTIVES


The authors sought to evaluate patient satisfaction with ASI for GL treatment employing 3 FACE-Q scales: facial appearance, psychological well-being, and aging appearance.
METHODS


This was a Phase 3, randomized, double-blind, placebo-controlled trial (NCT02353871) of ASI 50 units in adults with moderate-to-severe GL with 6-month follow-up.
RESULTS


Significantly greater least squares mean changes from baseline were associated with ASI treatment (N = 125) vs placebo (N = 59) for satisfaction with facial appearance at all visits until day 148 (5 months; P < 0.0001-0.0037), psychological well-being at all visits (P < 0.0001-0.0279), and aging appearance at all visits except day 148 (P < 0.0001-0.0409). Significant differences (ASI vs placebo) were observed at all visits for individual items: ""how rested your face looks"" (P < 0.0001-0.0415), ""I feel okay about myself"" (P = 0.0011-0.0399), and ""I feel attractive"" (P < 0.0001-0.0102). Maximal least squares mean (standard error) changes in aging appearance score were -1.4 (0.3; ASI) and -0.3 (0.4; placebo). Investigators' live assessment of GL at maximum frown significantly correlated with improvements in FACE-Q facial appearance and psychological scales (all patients: r = -0.41 and r = -0.36 [both P < 0.0001], respectively).
CONCLUSIONS


Significant improvements in patient satisfaction with aging, facial appearance, and, importantly, psychological well-being were demonstrated with ASI employing FACE-Q scales up to 5 to 6 months post-injection. Results support a long duration of efficacy with ASI and use of FACE-Q in future trials and clinical practice.
LEVEL OF EVIDENCE: 1


",2020,"At all visits there were significant differences (ASI vs placebo) for individual items: 'how rested your face looks' (p<0.0001-0.0415), 'I feel okay about myself' (p=0.0011-0.0399), and 'I feel attractive' (p<0.0001-0.0102).","['ASI 50 units in adults with moderate-to-severe GL, with 6-month follow-up']","['placebo', 'abobotulinumtoxinA (ASI, liquid-formulation']","['satisfaction with facial appearance', 'Patient Satisfaction', 'Maximal LS mean (standard error) changes in aging appearance score', 'patient satisfaction with aging and facial appearance', 'rested your face looks', 'FACE-Q facial appearance and psychological scales']","[{'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2719424', 'cui_str': 'abobotulinumtoxinA'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0282631', 'cui_str': 'Facies'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0222045'}]",,0.167176,"At all visits there were significant differences (ASI vs placebo) for individual items: 'how rested your face looks' (p<0.0001-0.0415), 'I feel okay about myself' (p=0.0011-0.0399), and 'I feel attractive' (p<0.0001-0.0102).","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ascher', 'Affiliation': 'Iena Plastic Surgery Clinic, Paris, France.'}, {'ForeName': 'Berthold', 'Initials': 'B', 'LastName': 'Rzany', 'Affiliation': 'Rzany and Hund, Berlin, Germany.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Kestemont', 'Affiliation': 'Mediti Centre, Antibes-Juan Les Pins, France.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Hilton', 'Affiliation': 'Dr. Hilton & Partner, Düsseldorf, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Heckmann', 'Affiliation': 'Starnberg Skin Centre, Starnberg, Germany.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Bodokh', 'Affiliation': 'Dermatology Department, Cannes Hospital, Cannes, France.'}, {'ForeName': 'Ernst Magnus', 'Initials': 'EM', 'LastName': 'Noah', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Red Cross Hospital, Kassel, Germany.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Boineau', 'Affiliation': 'Clinique Chirurgicale Bel-Air, Bordeaux, France.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kerscher', 'Affiliation': 'Division of Cosmetic Science, Department of Chemistry, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Volteau', 'Affiliation': 'Neurology Development, Ipsen Innovation, Les Ulis, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Le Berre', 'Affiliation': 'Neurology Development, Ipsen Innovation, Les Ulis, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Picaut', 'Affiliation': 'Neurology Development, Ipsen Innovation, Les Ulis, Paris, France.'}]",Aesthetic surgery journal,['10.1093/asj/sjz248']
947,30488531,Comparison of microneedling and full surface erbium laser dermabrasion for autologous cell suspension grafting in nonsegmental vitiligo: a randomized controlled trial.,,2019,,['nonsegmental vitiligo'],"['microneedling and full surface erbium laser dermabrasion', 'autologous cell suspension grafting']",[],"[{'cui': 'C0042900', 'cui_str': 'Vitiligo'}]","[{'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0011593', 'cui_str': 'Dermabrasion'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}]",[],,0.070296,,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lagrange', 'Affiliation': ""Department of Dermatology, Centre Hospitalier Universitaire Nice, Université Nice Côte d'Azur, Nice, France.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Montaudié', 'Affiliation': ""Department of Dermatology, Centre Hospitalier Universitaire Nice, Université Nice Côte d'Azur, Nice, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fontas', 'Affiliation': ""Department of Research and Innovation, Centre Hospitalier Universitaire Nice, Université Nice Côte d'Azur, Nice, France.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bahadoran', 'Affiliation': ""Department of Dermatology, Centre Hospitalier Universitaire Nice, Université Nice Côte d'Azur, Nice, France.""}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Lacour', 'Affiliation': ""Department of Dermatology, Centre Hospitalier Universitaire Nice, Université Nice Côte d'Azur, Nice, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Passeron', 'Affiliation': ""Department of Dermatology, Centre Hospitalier Universitaire Nice, Université Nice Côte d'Azur, Nice, France.""}]",The British journal of dermatology,['10.1111/bjd.17464']
948,26701964,Effect of treatment with rosiglitazone on high-sensitivity cardiac troponin levels among patients with type 2 diabetes mellitus.,"OBJECTIVE


To assess the impact of intermediate-term treatment with rosiglitazone on high-sensitivity cardiac troponin T levels among patients with type 2 diabetes mellitus with or at high risk of coronary artery disease.
METHODS


High-sensitivity cardiac troponin T level was measured at baseline and after 6 months of study treatment in a randomized trial comparing rosiglitazone versus placebo in patients with type 2 diabetes and prevalent cardiovascular disease or multiple cardiovascular disease risk factors. Univariable and multivariable linear regression analyses were performed to assess the effect of rosiglitazone versus placebo on high-sensitivity cardiac troponin T levels.
RESULTS


The study included 150 randomized participants, of whom 106 had paired baseline and end-of-study blood samples for analysis (mean age: 56 ± 8 years, 42% women; 8.8 years average type 2 diabetes duration; mean haemoglobin A1c of 7.5). Almost all study participants (93%) had detectable high-sensitivity cardiac troponin T (⩾ 3 ng/L) at baseline, including 23% with high-sensitivity cardiac troponin T levels exceeding the threshold commonly used to diagnose myocardial infarction (⩾ 14 ng/L). Change in high-sensitivity cardiac troponin T levels from baseline to follow-up was not significantly different between rosiglitazone and placebo groups (p = 0.316).
CONCLUSION


Rosiglitazone did not impact high-sensitivity cardiac troponin T levels, adding to the growing body of literature suggesting that the incremental heart failure risk associated with rosiglitazone is not mediated by direct myocardial injury.",2016,"Change in high-sensitivity cardiac troponin T levels from baseline to follow-up was not significantly different between rosiglitazone and placebo groups (p = 0.316).
","['patients with type 2 diabetes and prevalent cardiovascular disease or multiple cardiovascular disease risk factors', 'patients with type 2 diabetes mellitus with or at high risk of coronary artery disease', 'patients with type 2 diabetes mellitus', '150 randomized participants, of whom 106 had paired baseline and end-of-study blood samples for analysis (mean age: 56 ± 8 years, 42% women; 8.8 years average type 2 diabetes duration; mean haemoglobin A1c of 7.5']","['rosiglitazone', 'placebo', 'Rosiglitazone']","['detectable high-sensitivity cardiac troponin T', 'high-sensitivity cardiac troponin levels', 'high-sensitivity cardiac troponin T levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}]","[{'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C3538889', 'cui_str': 'Cardiac troponin T (substance)'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",150.0,0.285027,"Change in high-sensitivity cardiac troponin T levels from baseline to follow-up was not significantly different between rosiglitazone and placebo groups (p = 0.316).
","[{'ForeName': 'Usman I', 'Initials': 'UI', 'LastName': 'Salahuddin', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Ambarish', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Colby R', 'Initials': 'CR', 'LastName': 'Ayers', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'See', 'Affiliation': 'Department of Internal Medicine, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Neeland', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'M Odette', 'Initials': 'MO', 'LastName': 'Gore', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'D Bennett', 'Initials': 'DB', 'LastName': 'Grinsfelder', 'Affiliation': 'Texas Tech University Health Sciences Center School of Medicine, Lubbock, TX, USA.'}, {'ForeName': 'Shuaib M', 'Initials': 'SM', 'LastName': 'Abdullah', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Khera', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'de Lemos', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, USA Darren.McGuire@UTSouthwestern.edu.'}]",Diabetes & vascular disease research,['10.1177/1479164115618517']
949,31434809,Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients With Acute Coronary Syndrome　- The ODYSSEY J-IVUS Trial.,"BACKGROUND


In patients with acute coronary syndrome (ACS), alirocumab reduced the risk of recurring ischemic events. ODYSSEY J-IVUS assessed the effect of alirocumab on coronary atheroma volume in Japanese patients recently hospitalized with ACS and hypercholesterolemia, using intravascular ultrasound imaging analysis.Methods and Results:Patients (n=206) who at index ACS diagnosis either had low-density lipoprotein cholesterol (LDL-C) ≥2.59 mmol/L (≥100 mg/dL) despite stable statin therapy, or were not on statins with LDL-C levels above target after statin initiation, were randomized (1:1) to alirocumab (75 mg every 2 weeks [Q2 W]/up to 150 mg Q2 W), or standard of care (SoC; atorvastatin ≥10 mg/day or rosuvastatin ≥5 mg/day) for 36 weeks. The primary efficacy endpoint (week [W] 36 mean [standard error] percent change in normalized total atheroma volume [TAV] from baseline) was -3.1 (1.0)% with SoC vs. -4.8 (1.0)% with alirocumab (between-group difference: -1.6 [1.4]; P=0.23). W36 absolute change from baseline in percent atheroma volume was -1.3 (0.4)% (SoC) and -1.4 (0.4)% (alirocumab; nominal P=0.79). At W36, LDL-C was reduced from baseline by 13.4% (SoC) vs. 63.9% (alirocumab; nominal P<0.0001). In total, 61.8% (SoC) and 75.7% (alirocumab) of patients reported treatment-emergency adverse events.
CONCLUSIONS


In Japanese patients with ACS and hypercholesterolemia inadequately controlled despite statin therapy, from baseline to W36, a numerically greater percent reduction in normalized TAV was observed with alirocumab vs. SoC, which did not reach statistical significance.",2019,W36 absolute change from baseline in percent atheroma volume was -1.3,"['patients with acute coronary syndrome (ACS', 'Japanese patients with ACS and hypercholesterolemia', 'Japanese Patients With Acute Coronary Syndrome\u3000', 'Japanese patients recently hospitalized with ACS and hypercholesterolemia', 'Methods\u2004and\u2004Results:Patients (n=206) who at index ACS diagnosis either had low-density lipoprotein cholesterol (LDL-C) ≥2.59 mmol/L (≥100 mg/dL) despite stable statin therapy, or were not on statins with LDL-C levels above target after statin initiation']","['Alirocumab', 'standard of care (SoC; atorvastatin ≥10 mg/day or rosuvastatin', 'alirocumab']","['LDL-C', 'Coronary Atheroma Volume', 'normalized TAV', 'coronary atheroma volume', 'normalized total atheroma volume [TAV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0264683', 'cui_str': 'Coronary artery atheroma (disorder)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0264956', 'cui_str': 'Atheromatous Plaques'}]",36.0,0.0474424,W36 absolute change from baseline in percent atheroma volume was -1.3,"[{'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Ako', 'Affiliation': 'Department of Cardiovascular Medicine, Kitasato University School of Medicine.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Hibi', 'Affiliation': 'Division of Cardiology, Yokohama City University Medical Center.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Tsujita', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Hiro', 'Affiliation': 'Division of Cardiology, Department of Medicine, Nihon University School of Medicine.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Morino', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Iwate Medical University.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kozuma', 'Affiliation': 'Division of Cardiology, Teikyo University Hospital.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Shinke', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Showa University School of Medicine.'}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Otake', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine.'}, {'ForeName': 'Kiyoko', 'Initials': 'K', 'LastName': 'Uno', 'Affiliation': 'Cardiovascular Medical, Sanofi.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Louie', 'Affiliation': 'Regeneron Pharmaceuticals, Inc.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Takagi', 'Affiliation': 'Clinical Sciences and Operations, Sanofi.'}, {'ForeName': 'Katsumi', 'Initials': 'K', 'LastName': 'Miyauchi', 'Affiliation': 'Department of Cardiovascular Medicine, Juntendo University Graduate School of Medicine.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0412']
950,31555824,"Safety, Tolerability, and Immunogenicity of Plasmodium falciparum Sporozoite Vaccine Administered by Direct Venous Inoculation to Infants and Young Children: Findings From an Age De-escalation, Dose-Escalation, Double-blind, Randomized Controlled Study in Western Kenya.","BACKGROUND


The whole Plasmodium falciparum sporozoite (PfSPZ) vaccine is being evaluated for malaria prevention. The vaccine is administered intravenously for maximal efficacy. Direct venous inoculation (DVI) with PfSPZ vaccine has been safe, tolerable, and feasible in adults, but safety data for children and infants are limited.
METHODS


We conducted an age de-escalation, dose-escalation randomized controlled trial in Siaya County, western Kenya. Children and infants (aged 5-9 years, 13-59 months, and 5-12 months) were enrolled into 13 age-dose cohorts of 12 participants and randomized 2:1 to vaccine or normal saline placebo in escalating doses: 1.35 × 105, 2.7 × 105, 4.5 × 105, 9.0 × 105, and 1.8 × 106 PfSPZ, with the 2 highest doses given twice, 8 weeks apart. Solicited adverse events (AEs) were monitored for 8 days after vaccination, unsolicited AEs for 29 days, and serious AEs throughout the study. Blood taken prevaccination and 1 week postvaccination was tested for immunoglobulin G antibodies to P. falciparum circumsporozoite protein (PfCSP) using enzyme-linked immunosorbent assay.
RESULTS


Rates of AEs were similar in vaccinees and controls for solicited (35.7% vs 41.5%) and unsolicited (83.9% vs 92.5%) AEs, respectively. No related grade 3 AEs, serious AEs, or grade 3 laboratory abnormalities occurred. Most (79.0%) vaccinations were administered by a single DVI. Among those in the 9.0 × 105 and 1.8 × 106 PfSPZ groups, 36 of 45 (80.0%) vaccinees and 4 of 21 (19.0%) placebo controls developed antibodies to PfCSP (P < .001).
CONCLUSIONS


PfSPZ vaccine in doses as high as 1.8 × 106 can be administered to infants and children by DVI, and was safe, well tolerated, and immunogenic.
CLINICAL TRIALS REGISTRATION


NCT02687373.",2020,"RESULTS


Rates of AEs were similar in vaccinees and controls for solicited (35.7% vs. 41.5%) and unsolicited (83.9% vs. 92.5%) AEs, respectively.","['infants and young children', 'Children and infants (5-9 years, 13-59 months, and 5-12 months) were enrolled into 13 age-dose cohorts of 12 participants', 'Siaya County, western Kenya']","['placebo', 'Direct venous inoculation (DVI) with PfSPZ Vaccine', 'PfSPZ Vaccine', 'vaccine or normal saline placebo in escalating doses: 1.35x105, 2.7x105, 4.5x105, 9.0x105, and 1.8x106Plasmodium falciparum sporozoites (PfSPZ']","['grade 3 AEs, SAEs, or grade 3 laboratory abnormalities', 'Safety, tolerability, and immunogenicity', 'Solicited adverse events (AEs']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0562648', 'cui_str': 'Sporozoites'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0639010', 'cui_str': '3-AES'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.234921,"RESULTS


Rates of AEs were similar in vaccinees and controls for solicited (35.7% vs. 41.5%) and unsolicited (83.9% vs. 92.5%) AEs, respectively.","[{'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Steinhardt', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Richie', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Yego', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Dorcas', 'Initials': 'D', 'LastName': 'Akach', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Hamel', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gutman', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Wiegand', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Nzuu', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Dungani', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Kc', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Tooba', 'Initials': 'T', 'LastName': 'Murshedkar', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'L W Preston', 'Initials': 'LWP', 'LastName': 'Church', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'B Kim Lee', 'Initials': 'BKL', 'LastName': 'Sim', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Peter F', 'Initials': 'PF', 'LastName': 'Billingsley', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'James', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Yonas', 'Initials': 'Y', 'LastName': 'Abebe', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kariuki', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Samuels', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Kephas', 'Initials': 'K', 'LastName': 'Otieno', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Sang', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.'}, {'ForeName': 'S Patrick', 'Initials': 'SP', 'LastName': 'Kachur', 'Affiliation': 'Malaria Branch, Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Styers', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Schlessman', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland, USA.'}, {'ForeName': 'Ginnie', 'Initials': 'G', 'LastName': 'Abarbanell', 'Affiliation': ""Washington University School of Medicine and St Louis Children's Hospital, St Louis, Missouri, USA.""}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hoffman', 'Affiliation': 'Sanaria Inc, Rockville, Maryland, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Seder', 'Affiliation': 'National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Oneko', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz925']
951,27084025,Process Evaluation of the Project SHINE Intervention for African American Families: An Integrated Positive Parenting and Peer Monitoring Approach to Health Promotion.,"This study describes the process evaluation of Project SHINE, a randomized family-based health promotion intervention that integrated parenting and peer monitoring for improving sedentary behavior, physical activity, and diet in African American families. Adolescent-parent dyads (n = 89) were randomized to a 6-week behavioral, positive parenting, and peer monitoring skills intervention or a general health education comparison condition. Process evaluation included observational ratings of fidelity, attendance records, psychosocial measures, and qualitative interviews. Results indicated that the intervention was delivered with high fidelity based on facilitator adherence (>98% of content delivered) and competent use of theoretically based behavior change and positive parenting skills (100% of ratings >3 on a 1-4 scale). Although only 43% of peers attended the ""bring a friend"" session, overall attendance was high (4.39 ± 1.51 sessions) as was the retention rate (88%). Parents in the intervention condition reported significant improvements in communication related to adolescents' engagement in health behaviors both on their own and with peers. These findings were supported by qualitative themes related to improvements in family communication and connectedness. This study provides an innovative example of how future family-based health promotion trials can expand their process evaluation approaches by assessing theoretically relevant positive parenting variables as part of ongoing monitoring.",2016,Parents in the intervention condition reported significant improvements in communication related to adolescents' engagement in health behaviors both on their own and with peers.,"['Adolescent-parent dyads (n = 89', 'African American Families', 'African American families']","['Project SHINE Intervention', 'health promotion intervention that integrated parenting and peer monitoring', '6-week behavioral, positive parenting, and peer monitoring skills intervention or a general health education comparison condition']","['overall attendance', ""communication related to adolescents' engagement in health behaviors"", 'retention rate', 'behavior change and positive parenting skills', 'facilitator adherence', 'observational ratings of fidelity, attendance records, psychosocial measures, and qualitative interviews']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018701'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018687'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]",89.0,0.0170063,Parents in the intervention condition reported significant improvements in communication related to adolescents' engagement in health behaviors both on their own and with peers.,"[{'ForeName': 'Sara M', 'Initials': 'SM', 'LastName': 'St George', 'Affiliation': 'University of Miami Miller School of Medicine, Miami, FL, USA s.stgeorge@med.miami.edu.'}, {'ForeName': 'Dawn K', 'Initials': 'DK', 'LastName': 'Wilson', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'McDaniel', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Kassandra A', 'Initials': 'KA', 'LastName': 'Alia', 'Affiliation': 'University of South Carolina, Columbia, SC, USA.'}]",Health promotion practice,['10.1177/1524839916635977']
952,31842232,Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial.,"Background


Substitutive hospital-level care in a patient's home may reduce cost, health care use, and readmissions while improving patient experience, although evidence from randomized controlled trials in the United States is lacking.
Objective


To compare outcomes of home hospital versus usual hospital care for patients requiring admission.
Design


Randomized controlled trial. (ClinicalTrials.gov: NCT03203759).
Setting


Academic medical center and community hospital.
Patients


91 adults (43 home and 48 control) admitted via the emergency department with selected acute conditions.
Intervention


Acute care at home, including nurse and physician home visits, intravenous medications, remote monitoring, video communication, and point-of-care testing.
Measurements


The primary outcome was the total direct cost of the acute care episode (sum of costs for nonphysician labor, supplies, medications, and diagnostic tests). Secondary outcomes included health care use and physical activity during the acute care episode and at 30 days.
Results


The adjusted mean cost of the acute care episode was 38% (95% CI, 24% to 49%) lower for home patients than control patients. Compared with usual care patients, home patients had fewer laboratory orders (median per admission, 3 vs. 15), imaging studies (median, 14% vs. 44%), and consultations (median, 2% vs. 31%). Home patients spent a smaller proportion of the day sedentary (median, 12% vs. 23%) or lying down (median, 18% vs. 55%) and were readmitted less frequently within 30 days (7% vs. 23%).
Limitation


The study involved 2 sites, a small number of home physicians, and a small sample of highly selected patients (with a 63% refusal rate among potentially eligible patients); these factors may limit generalizability.
Conclusion


Substitutive home hospitalization reduced cost, health care use, and readmissions while increasing physical activity compared with usual hospital care.
Primary Funding Source


Partners HealthCare Center for Population Health and internal departmental funds.",2020,"Home patients spent a smaller proportion of the day sedentary (median, 12% vs. 23%) or lying down (median, 18% vs. 55%) and were readmitted less frequently within 30 days (7% vs. 23%).
","['Acutely Ill Adults', '2 sites, a small number of home physicians, and a small sample of highly selected patients (with a 63% refusal rate among potentially eligible patients', 'Patients\n\n\n91 adults (43 home and 48 control) admitted via the emergency department with selected acute conditions', 'patients requiring admission']",['home hospital versus usual hospital care'],"['health care use and physical activity during the acute care episode and at 30 days', 'laboratory orders', 'cost, health care use, and readmissions while increasing physical activity', 'adjusted mean cost of the acute care episode', 'total direct cost of the acute care episode (sum of costs for nonphysician labor, supplies, medications, and diagnostic tests', 'smaller proportion of the day sedentary']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0085554', 'cui_str': 'Patient Care Episodes'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4302923', 'cui_str': 'Laboratory order (record artifact)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0086143'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}]",91.0,0.165426,"Home patients spent a smaller proportion of the day sedentary (median, 12% vs. 23%) or lying down (median, 18% vs. 55%) and were readmitted less frequently within 30 days (7% vs. 23%).
","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Levine', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (D.M.L., K.O., B.B., A.S., J.L.S.).""}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Ouchi', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (D.M.L., K.O., B.B., A.S., J.L.S.).""}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Blanchfield', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (D.M.L., K.O., B.B., A.S., J.L.S.).""}, {'ForeName': 'Agustina', 'Initials': 'A', 'LastName': 'Saenz', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (D.M.L., K.O., B.B., A.S., J.L.S.).""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Burke', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (K.B., M.P.).""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Paz', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (K.B., M.P.).""}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Diamond', 'Affiliation': 'Partners HealthCare at Home, Waltham, Massachusetts (K.D.).'}, {'ForeName': 'Charles T', 'Initials': 'CT', 'LastName': 'Pu', 'Affiliation': 'Harvard Medical School, Massachusetts General Hospital, and Partners HealthCare System Center for Population Health, Boston, Massachusetts (C.T.P.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Schnipper', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts (D.M.L., K.O., B.B., A.S., J.L.S.).""}]",Annals of internal medicine,['10.7326/M19-0600']
953,25872925,Investigating the non-specific effects of BCG vaccination on the innate immune system in Ugandan neonates: study protocol for a randomised controlled trial.,"BACKGROUND


The potential for Bacillus Calmette-Guérin (BCG) vaccination to protect infants against non-mycobacterial disease has been suggested by a randomised controlled trial conducted in low birth-weight infants in West Africa. Trials to confirm these findings in healthy term infants, and in a non-West African setting, have not yet been carried out. In addition, a biological mechanism to explain such heterologous effects of BCG in the neonatal period has not been confirmed. This trial aims to address these issues by evaluating whether BCG non-specifically enhances the innate immune system in term Ugandan neonates, leading to increased protection from a variety of infectious diseases.
METHODS


This trial will be an investigator-blinded, randomised controlled trial of 560 Ugandan neonates, comparing those receiving BCG at birth with those receiving BCG at 6 weeks of age. This design allows comparison of outcomes between BCG-vaccinated and -naïve infants until 6 weeks of age, and between early and delayed BCG-vaccinated infants from 6 weeks of age onwards. The primary outcomes of the study will be a panel of innate immune parameters. Secondary outcomes will include clinical illness measures.
DISCUSSION


Investigation of the possible broadly protective effects of neonatal BCG immunisation, and the optimal vaccination timing to produce these effects, could have profound implications for public healthcare policy. Evidence of protection against heterologous pathogens would underscore the importance of prioritising BCG administration in a timely manner for all infants, provide advocacy against the termination of BCG's use and support novel anti-tuberculous vaccine strategies that would safeguard such beneficial effects.
TRIAL REGISTRATION


ISRCTN59683017 : registration date: 15 January 2014.",2015,"This trial aims to address these issues by evaluating whether BCG non-specifically enhances the innate immune system in term Ugandan neonates, leading to increased protection from a variety of infectious diseases.
","['low birth-weight infants in West Africa', '560 Ugandan neonates, comparing those receiving BCG at birth with those receiving BCG at 6\xa0weeks of age', 'healthy term infants', 'infants until 6\xa0weeks of age, and between early and delayed BCG-vaccinated infants from 6\xa0weeks of age onwards', 'Ugandan neonates']","['BCG-vaccinated and -naïve', 'Bacillus Calmette-Guérin (BCG) vaccination', 'BCG vaccination']","['clinical illness measures', 'panel of innate immune parameters']","[{'cui': 'C0021288', 'cui_str': 'Low Birth Weight Infant'}, {'cui': 'C0001747', 'cui_str': 'West Africa'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0199804', 'cui_str': 'BCG immunization'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",560.0,0.326631,"This trial aims to address these issues by evaluating whether BCG non-specifically enhances the innate immune system in term Ugandan neonates, leading to increased protection from a variety of infectious diseases.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Prentice', 'Affiliation': 'Wellcome Trust - Bloomsbury Centre for Global Health Research, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Sarah.prentice@lshtm.ac.uk.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Emily.webb@lshtm.ac.uk.'}, {'ForeName': 'Hazel M', 'Initials': 'HM', 'LastName': 'Dockrell', 'Affiliation': 'Wellcome Trust - Bloomsbury Centre for Global Health Research, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Hazel.dockrell@lshtm.ac.uk.'}, {'ForeName': 'Pontiano', 'Initials': 'P', 'LastName': 'Kaleebu', 'Affiliation': 'MRC/Uganda Virus Research Institute on AIDS, Plot 51-59, Nakiwogo Road, PO Box 49, Entebbe, Uganda. pontiano.kaleebu@mrcuganda.org.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Elliott', 'Affiliation': 'Wellcome Trust - Bloomsbury Centre for Global Health Research, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. alison.elliott@mrcuganda.org.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cose', 'Affiliation': 'Department of Infection and Immunology, London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK. Stephen.cose@lshtm.ac.uk.'}]",Trials,['10.1186/s13063-015-0682-5']
954,32416926,[Effect of activities profile variations on health-related quality of life among breast cancer patients: Secondary exploratory analysis from PASAPAS study data].,"INTRODUCTION


Lifestyle changes in breast cancer patients, by physical activity increasing, are becoming a main objective in supportive care. The objective of this study was to explore the impact of the daily activity profile evolution on the quality of life among this public.
METHODS


Sixty patients (18 to 75 years) with non-metastatic breast cancer were randomized to a 2:1 ratio (physical activity intervention; control) in the PASAPAS randomized clinical trial. Multiple linear regression analyzes were computed to explain quality of life scores 6 months after the start of adjuvant therapy. Variables retained were the baseline quality of life scores, the anxiety trait, the randomization arm, the variations of time spent in different physical activity classes ([3-4 [MET, [4-6 [MET, ≥6 MET) and in sedentary behaviors.
RESULTS


Only the decrease in time spent in sedentary behaviors really appeared as a predictor of the quality of physical life. Participation in the intervention group appeared as a predictor of quality of mental life.
DISCUSSION


Results plead in favor of sedentary life style decrease as part of the objectives of care program for women with breast cancer. It also highlights the need of collective supervised sessions implemented by competent staff. This research also suggests that the dynamics of daily activity profile variations should be studied further in association to quality of life.",2020,"Participation in the intervention group appeared as a predictor of quality of mental life.
","['breast cancer patients', 'Sixty patients (18 to 75 years) with non-metastatic breast cancer', 'women with breast cancer']","['2:1 ratio (physical activity intervention; control', 'activities profile variations']","['quality of mental life', 'quality of physical life', 'baseline quality of life scores, the anxiety trait, the randomization arm, the variations of time spent in different physical activity classes', 'health-related quality of life', 'time spent in sedentary behaviors']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}]",,0.041616,"Participation in the intervention group appeared as a predictor of quality of mental life.
","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Reynes', 'Affiliation': ""Université Lyon, université Claude-Bernard Lyon 1, laboratoire sur les vulnérabilités et l'innovation dans le sport (L-ViS, EA 7428), 69622 Lyon, France; UFR STAPS, 27-29, boulevard du 11 Novembre 1918, 69622 Villeurbanne cedex, France. Electronic address: eric.reynes@univ-lyon1.fr.""}, {'ForeName': 'Sophie E', 'Initials': 'SE', 'LastName': 'Berthouze', 'Affiliation': 'Université Lyon, université Claude-Bernard Lyon 1, laboratoire interuniversitaire de biologie de la motricité (LIBM, EA 7424), 69622 Lyon, France; UFR STAPS, 27-29, boulevard du 11 Novembre 1918, 69622 Villeurbanne cedex, France.'}, {'ForeName': 'Aude-Marie', 'Initials': 'AM', 'LastName': 'Foucaut', 'Affiliation': 'Université Sorbonne Paris Nord, laboratoire éducations et pratiques de santé (LEPS, UR 3412), Département STAPS, 74, rue Marcel-Cachin, 93017 Bobigny, France; Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Morelle', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France; Université de Lyon, GATE Lyon Saint-Étienne, UMR-CNRS 5824, 69007 Lyon, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Bachmann', 'Affiliation': 'Centre Léon Bérard, unité de nutrition et diététique\xa0-\xa0DISSPO, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Kempf-Lépine', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France; Centre Léon Bérard, département cancer environnement, laboratoire «\xa0Santé, Individu, Société\xa0» EAM 4128, faculté de médecine Laënnec, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Meyrand', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Baudinet', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Carretier', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, laboratoire «\xa0Santé, Individu, Société\xa0» EAM 4128, faculté de médecine Laënnec, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Trédan', 'Affiliation': ""Centre Léon Bérard, département d'oncologie médicale, 28, rue Laennec, 69008 Lyon, France.""}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Fervers', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France; Centre de recherche en cancérologie de Lyon, UMR, Inserm 1052, CNRS 5286 CLB, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Touillaud', 'Affiliation': 'Centre Léon Bérard, département cancer environnement, 28, rue Laennec, 69008 Lyon, France; Centre de recherche en cancérologie de Lyon, UMR, Inserm 1052, CNRS 5286 CLB, 28, rue Laennec, 69008 Lyon, France.'}]",Bulletin du cancer,['10.1016/j.bulcan.2020.03.014']
955,32417345,Randomized controlled trial to identify the optimal radiotherapy scheme for palliative treatment of incurable head and neck squamous cell carcinoma.,"BACKGROUND


No randomized controlled trials (RCT) have yet identified the optimal palliative radiotherapy scheme in patients with incurable head and neck squamous cell carcinoma (HNSCC). We conducted RCT to compare two radiation schemes in terms of efficacy, toxicity and quality-of-life (QoL).
MATERIALS AND METHODS


Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease were randomly assigned in 1:1 ratio to arm 1 (36 Gy in 6 fractions, twice a week) or arm 2 (50 Gy in 16 fractions, four times a week).
RESULTS


The trial was discontinued early because of slow accrual (34 patients enrolled). Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p = 0.476). The median time to loco-regional progression was not reached. The loco-regional control rates at 1 year was 57.4% and 69.3% in arm 1 and 2 (p = 0.450, HR = 0.56, 95%CI 0.12-2.58). One-year overall survival was 33.3% and 57.1%, with medians of 35.4 and 59.5 weeks, respectively (p = 0.215, HR = 0.55, 95%CI 0.21-1.43). Acute grade ≥3 toxicity was lower in arm 1 (16.7% versus 57.1%, p = 0.027), with the largest difference in grade 3 mucositis (5.6% versus 42.9%, p = 0.027). However, no significant deterioration in any of the patient-reported QoL-scales was found.
CONCLUSION


No solid conclusion could be made on this incomplete study which is closed early. Long-course radiotherapy did not show significantly better oncologic outcomes, but was associated with more acute grade 3 mucositis. No meaningful differences in QoL-scores were found. Therefore, the shorter schedule might be carefully advocated. However, this recommendation should be interpreted with great caution because of the inadequate statistical power.",2020,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"['patients with incurable head and neck squamous cell carcinoma (HNSCC', 'incurable head and neck squamous cell carcinoma', 'Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease']",[],"['grade 3 mucositis', 'QoL-scores', 'efficacy, toxicity and quality-of-life (QoL', 'Acute grade ≥3 toxicity', 'median time to loco-regional progression', 'QoL-scales', 'overall survival', 'loco-regional control rates', 'acute grade 3 mucositis', 'oncologic outcomes', 'Objective response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",[],"[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",34.0,0.193028,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"[{'ForeName': 'Abrahim', 'Initials': 'A', 'LastName': 'Al-Mamgani', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands. Electronic address: a.almamgani@nki.nl.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Kessels', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelia G', 'Initials': 'CG', 'LastName': 'Verhoef', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Navran', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Hamming-Vrieze', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes H A M', 'Initials': 'JHAM', 'LastName': 'Kaanders', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Roel J H M', 'Initials': 'RJHM', 'LastName': 'Steenbakkers', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tans', 'Affiliation': 'Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hoebers', 'Affiliation': 'Department of Radiation Oncology (MAASTRO Clinic), GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Ong', 'Affiliation': 'Department of Radiation Oncology, Medisch Spectrum Twente, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Werkhoven', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes A', 'Initials': 'JA', 'LastName': 'Langendijk', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.020']
956,26051455,Serum biomarkers may help predict successful misoprostol management of early pregnancy failure.,"In order to simplify management of early pregnancy loss, our goal was to elucidate predictors of successful medical management of miscarriage with a single dose of misoprostol. In this secondary analysis of data from a multicenter randomized controlled trial, candidate biomarkers were compared between 49 women with missed abortion who succeeded in passing their pregnancy with a single dose of misoprostol and 46 women who did not pass their pregnancy with a misoprostol single dose. We computed the precision of trophoblastic protein and hormone concentrations to discriminate between women who succeed or fail single dose misoprostol management. We also included demographic factors in our analyses. We found overlap in the concentrations of the individual markers between women who succeeded and failed single-dose misoprostol. However, hCG levels ≥ 4000 mIU/mL and ADAM-12 levels ≥ 2500 pg/mL were independently associated with complete uterine expulsion after one dose of misoprostol in our population. A multivariable logistic model for success included non-Hispanic ethnicity and parity <2 in addition to hCG ≥ 4000 mIU/mL and ADAM-12 ≥ 2500 pg/mL and had an area under the receiver operating characteristic (ROC) of 0.81 (95% confidence interval: 72-90%). Categorizing women with a predicted probability of ≥ 0.65 resulted in a sensitivity of 75.0%, specificity 77.1% and positive predictive value of 81.8%. While preliminary, our data suggest that serum biomarkers, especially when combined with demographic characteristics, may be helpful in guiding patient decision-making regarding the management of early pregnancy failure (EPF). Further study is warranted.",2015,"Categorizing women with a predicted probability of ≥ 0.65 resulted in a sensitivity of 75.0%, specificity 77.1% and positive predictive value of 81.8%.","['and 46 women who did not pass their pregnancy with a misoprostol single dose', 'women who succeed or fail single dose misoprostol management', '49 women with missed abortion who succeeded in passing their pregnancy with a single dose of']",['misoprostol'],"['hCG levels ≥ 4000 mIU/mL and ADAM-12 levels ≥', 'complete uterine expulsion']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0000814', 'cui_str': 'Silent miscarriage'}]","[{'cui': 'C0085174', 'cui_str': 'Misoprostol'}]","[{'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3842327', 'cui_str': '4000 (qualifier value)'}, {'cui': 'C0439457', 'cui_str': 'milliinternational unit/milliliter'}, {'cui': 'C1529905', 'cui_str': '(123I)ADAM'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1293107', 'cui_str': 'Expulsion (procedure)'}]",49.0,0.290729,"Categorizing women with a predicted probability of ≥ 0.65 resulted in a sensitivity of 75.0%, specificity 77.1% and positive predictive value of 81.8%.","[{'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': 'Penn Family Planning and Pregnancy Loss Center, Penn Medicine, University of Pennsylvania, Perelman School of Medicine, 1000 Courtyard, 3400 Spruce Street, Philadelphia, PA 19104, United States. Electronic address: schreibe@upenn.edu.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Ratcliffe', 'Affiliation': 'Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Perelman School of Medicine, United States.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Quinley', 'Affiliation': 'Highland General Hospital | Alameda County Health System, United States.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, United States.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Department of Biostatistics and Epidemiology, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Perelman School of Medicine, United States.'}]",Reproductive biology,['10.1016/j.repbio.2015.02.001']
957,32418302,A pilot non-inferiority randomized controlled trial to assess automatic adjustments of insulin doses in adolescents with type 1 diabetes on multiple daily injections therapy.,"BACKGROUND


Multiple daily injections (MDI) therapy for type 1 diabetes involves basal and bolus insulin doses. Non-optimal insulin doses contribute to the lack of satisfactory glycemic control. We aimed to evaluate the feasibility of an algorithm that optimizes daily basal and bolus doses using glucose monitoring systems for MDI therapy users.
METHODS


We performed a pilot, non-inferiority, randomized, parallel study at a diabetes camp comparing basal-bolus insulin dose adjustments made by camp physicians (PA) and a learning algorithm (LA), in children and adolescents on MDI therapy. Participants wore a glucose sensor and underwent 11 days of daily dose adjustments in either arm. Algorithm adjustments were reviewed and approved by a physician. The last 7 days were examined for outcomes.
RESULTS


Twenty-one youths (age 13.3 [SD, 3.7] years; 13 females; HbA1c 8.6% [SD, 1.8]) were randomized to either group (LA [n = 10] or PA [n = 11]). The algorithm made 293 adjustments with a 92% acceptance rate from the camp physicians. In the last 7 days, the time in target glucose (3.9-10 mmol/L) in LA (39.5%, SD, 20.7) was similar to PA (38.4%, SD, 15.6) (P = .89). The number of hypoglycemic events per day in LA (0.3, IQR, [0.1-0.6]) was similar to PA (0.2, IQR, [0.0-0.4]) (P = .42). There was no incidence of severe hypoglycemia nor ketoacidosis.
CONCLUSIONS


In this pilot study, glycemic outcomes in the LA group were similar to the PA group. This algorithm has the potential to facilitate MDI therapy, and longer and larger studies are warranted.",2020,"There was no incidence of severe hypoglycemia nor ketoacidosis.
","['MDI therapy users', '21 youths (age 13.3 (SD, 3.7) years; 13 females; HbA1c 8.6% (SD, 1.8', 'Adolescents with Type 1 Diabetes on Multiple Daily Injections Therapy', 'children and adolescents on MDI therapy']","['basal-bolus insulin dose adjustments made by camp physicians (PA) and a learning algorithm (LA', 'Multiple daily injections (MDI) therapy']","['glycemic outcomes', 'time in target glucose', 'severe hypoglycemia nor ketoacidosis', 'number of hypoglycemic events']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",293.0,0.0480095,"There was no incidence of severe hypoglycemia nor ketoacidosis.
","[{'ForeName': 'Anas', 'Initials': 'A', 'LastName': 'El Fathi', 'Affiliation': 'Department of Electrical and Computer Engineering, McGill University, Montreal, Canada.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Palisaitis', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Canada.'}, {'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'von Oettingen', 'Affiliation': ""Montreal Children's Hospital, Pediatric Endocrinology, Montréal, Canada.""}, {'ForeName': 'Preetha', 'Initials': 'P', 'LastName': 'Krishnamoorthy', 'Affiliation': ""Montreal Children's Hospital, Pediatric Endocrinology, Montréal, Canada.""}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kearney', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Legault', 'Affiliation': ""Montreal Children's Hospital, Pediatric Endocrinology, Montréal, Canada.""}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Haidar', 'Affiliation': 'Department of Biomedical Engineering, McGill University, Montreal, Canada.'}]",Pediatric diabetes,['10.1111/pedi.13052']
958,26085041,"Ziprasidone Augmentation of Escitalopram for Major Depressive Disorder: Efficacy Results From a Randomized, Double-Blind, Placebo-Controlled Study.","OBJECTIVE


The authors sought to test the efficacy of adjunctive ziprasidone in adults with nonpsychotic unipolar major depression experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram.
METHOD


This was an 8-week, randomized, double-blind, parallel-group, placebo-controlled trial conducted at three academic medical centers. Participants were 139 outpatients with persistent symptoms of major depression after an 8-week open-label trial of escitalopram (phase 1), randomly assigned in a 1:1 ratio to receive adjunctive ziprasidone (escitalopram plus ziprasidone, N=71) or adjunctive placebo (escitalopram plus placebo, N=68), with 8 weekly follow-up assessments. The primary outcome measure was clinical response, defined as a reduction of at least 50% in score on the 17-item Hamilton Depression Rating Scale (HAM-D). The Hamilton Anxiety Rating scale (HAM-A) and Visual Analog Scale for Pain were defined a priori as key secondary outcome measures.
RESULTS


Rates of clinical response (35.2% compared with 20.5%) and mean improvement in HAM-D total scores (-6.4 [SD=6.4] compared with -3.3 [SD=6.2]) were significantly greater for the escitalopram plus ziprasidone group. Several secondary measures of antidepressant efficacy also favored adjunctive ziprasidone. The escitalopram plus ziprasidone group also showed significantly greater improvement on HAM-A score but not on Visual Analog Scale for Pain score. Ten (14%) patients in the escitalopram plus ziprasidone group discontinued treatment because of intolerance, compared with none in the escitalopram plus placebo group.
CONCLUSIONS


Ziprasidone as an adjunct to escitalopram demonstrated antidepressant efficacy in adult patients with major depressive disorder experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram.",2015,The escitalopram plus ziprasidone group also showed significantly greater improvement on HAM-A score but not on Visual Analog Scale for Pain score.,"['adult patients with major depressive disorder experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram', 'Major Depressive Disorder', 'controlled trial conducted at three academic medical centers', 'adults with nonpsychotic unipolar major depression experiencing persistent symptoms after 8 weeks of open-label treatment with escitalopram', 'Participants were 139 outpatients with persistent symptoms of major depression after an 8-week open-label trial of escitalopram (phase 1']","['placebo', 'Placebo', 'adjunctive ziprasidone (escitalopram plus ziprasidone, N=71) or adjunctive placebo (escitalopram plus placebo', 'ziprasidone', 'Ziprasidone Augmentation of Escitalopram', 'Ziprasidone', 'adjunctive ziprasidone']","['Visual Analog Scale for Pain score', 'antidepressant efficacy', 'Hamilton Anxiety Rating scale (HAM-A) and Visual Analog Scale for Pain', 'Rates of clinical response', 'HAM-D total scores', 'clinical response, defined as a reduction of at least 50% in score on the 17-item Hamilton Depression Rating Scale (HAM-D', 'HAM-A score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0443340', 'cui_str': 'Unipolar (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439559', 'cui_str': 'Phase 1 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0380393', 'cui_str': 'ziprasidone'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",139.0,0.397755,The escitalopram plus ziprasidone group also showed significantly greater improvement on HAM-A score but not on Visual Analog Scale for Pain score.,"[{'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'From the Massachusetts General Hospital Clinical Trials Network and Institute, the Massachusetts General Hospital Depression Clinical and Research Program, and Harvard Medical School, Boston; the Department of Psychiatry and Psychology, Mayo Medical School, Rochester, Minn.; the Department of Psychiatry and Behavioral Neurobiology, University of Alabama-Birmingham School of Medicine, Birmingham.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'From the Massachusetts General Hospital Clinical Trials Network and Institute, the Massachusetts General Hospital Depression Clinical and Research Program, and Harvard Medical School, Boston; the Department of Psychiatry and Psychology, Mayo Medical School, Rochester, Minn.; the Department of Psychiatry and Behavioral Neurobiology, University of Alabama-Birmingham School of Medicine, Birmingham.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Baer', 'Affiliation': 'From the Massachusetts General Hospital Clinical Trials Network and Institute, the Massachusetts General Hospital Depression Clinical and Research Program, and Harvard Medical School, Boston; the Department of Psychiatry and Psychology, Mayo Medical School, Rochester, Minn.; the Department of Psychiatry and Behavioral Neurobiology, University of Alabama-Birmingham School of Medicine, Birmingham.'}, {'ForeName': 'Michaela B', 'Initials': 'MB', 'LastName': 'Swee', 'Affiliation': 'From the Massachusetts General Hospital Clinical Trials Network and Institute, the Massachusetts General Hospital Depression Clinical and Research Program, and Harvard Medical School, Boston; the Department of Psychiatry and Psychology, Mayo Medical School, Rochester, Minn.; the Department of Psychiatry and Behavioral Neurobiology, University of Alabama-Birmingham School of Medicine, Birmingham.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Jaeger', 'Affiliation': 'From the Massachusetts General Hospital Clinical Trials Network and Institute, the Massachusetts General Hospital Depression Clinical and Research Program, and Harvard Medical School, Boston; the Department of Psychiatry and Psychology, Mayo Medical School, Rochester, Minn.; the Department of Psychiatry and Behavioral Neurobiology, University of Alabama-Birmingham School of Medicine, Birmingham.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Bobo', 'Affiliation': 'From the Massachusetts General Hospital Clinical Trials Network and Institute, the Massachusetts General Hospital Depression Clinical and Research Program, and Harvard Medical School, Boston; the Department of Psychiatry and Psychology, Mayo Medical School, Rochester, Minn.; the Department of Psychiatry and Behavioral Neurobiology, University of Alabama-Birmingham School of Medicine, Birmingham.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'From the Massachusetts General Hospital Clinical Trials Network and Institute, the Massachusetts General Hospital Depression Clinical and Research Program, and Harvard Medical School, Boston; the Department of Psychiatry and Psychology, Mayo Medical School, Rochester, Minn.; the Department of Psychiatry and Behavioral Neurobiology, University of Alabama-Birmingham School of Medicine, Birmingham.'}]",The American journal of psychiatry,['10.1176/appi.ajp.2015.14101251']
959,32417348,Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial.,"BACKGROUND


Concurrent chemoradiotherapy (CRT) is the standard of care (SoC) in locally advanced (LA) head and neck squamous cell carcinomas (HNSCC). This trial was designed to test whether dose-escalated IMRT and cisplatin could improve locoregional control without increasing complications over 3D-radiotherapy.
METHODS


Patients were randomized between 70 Gy/35F in 7 weeks with 3D-RT (Arm A) versus 75 Gy/35F with IMRT (Arm B). Both arms received 50 Gy in 25 fractions followed by a sequential boost of 20 Gy/10F in Arm A and 25 Gy/10F to gross tumor volume in Arm B, as well as 3 cycles of cisplatin at 100 mg/m2 during RT. The primary endpoint was locoregional progression (LRP).
RESULTS


188 patients were randomized: 85% oropharynx and 73% stage IVa. P16 status was documented for 137 oropharyngeal tumors with P16+ in 53 (39%) patients; and 90% were smokers. Median follow-up was 60.5 months. Xerostomia was markedly decreased in arm B (p < 0.0001). The 1-year grade ≥2 xerostomia (RTOG criteria) was 63% vs 23% and 3-year 45% vs 11% in arms A and B, respectively. Xerostomia LENT-SOMA scale was also reduced in arm B. Dose-escalated IMRT did not reduce LRP with an adjusted HR of 1.13 [95%CI = 0.64-1.98] (p = 0.68). Survival was not different (adjusted HR: 1.19 [95%CI = 0.78-1.81], p = 0.42). No interaction between p16 and treatment effect was found.
CONCLUSION


Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT. This trial reinforces the evidence showing IMRT reduces xerostomia in LA-HNSCC treated with radiotherapy. Clinicaltrial.gov: NCT00158678.",2020,"CONCLUSION


Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT.","['locally advanced (LA) head and neck squamous cell carcinomas (HNSCC', '188 patients were randomized: 85% oropharynx and 73% stage IVa', 'patients', 'locally advanced head and neck squamous cell carcinomas (HNSCC']","['Concurrent chemoradiotherapy (CRT', 'radiotherapy', 'Concurrent cisplatin and Dose escalation with Intensity-modulated radiotherapy (IMRT', 'cisplatin', 'conventional radiotherapy', 'IMRT and cisplatin', '75Gy/35F with IMRT']","['1-year grade ≥ 2 xerostomia (RTOG criteria', 'Xerostomia LENT-SOMA scale', 'Survival', 'P16 status', 'Xerostomia', 'locoregional progression (LRP', 'xerostomia']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0441773', 'cui_str': 'Stage IVa'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0702216', 'cui_str': 'Soma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",188.0,0.356655,"CONCLUSION


Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT.","[{'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France. Electronic address: yungan.tao@gustaveroussy.fr.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Auperin', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France; INSERM 1018, Villefjuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blanchard', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Institut Sainte Catherine, Avignon, France.'}, {'ForeName': 'Xu-Shan', 'Initials': 'XS', 'LastName': 'Sun', 'Affiliation': 'Hopital Nord Franche-Comté de Montbéliard & CHRU de Besançon, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rives', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Castelli', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Graff', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France; Centre Alexis Vautrin, Nancy, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Wong Hee Kam', 'Affiliation': 'AP-HM Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France; Centre francois Baclesse, Caen, France.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Veresezan', 'Affiliation': 'Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Heymann', 'Affiliation': 'Clinique Sainte Anne, Strasbourg, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Renard-Oldrini', 'Affiliation': 'Centre Alexis Vautrin, Nancy, France.'}, {'ForeName': 'Cédrik', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Cornely', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Casiraghi', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boisselier', 'Affiliation': 'Centre Eugène Marquis, Rennes, France; Institut du Cancer de Montpellier, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Lapeyre', 'Affiliation': 'Centre Alexis Vautrin, Nancy, France; Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Biau', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France; CHUV Lausanne, Switzerland. Electronic address: jean.bourhis@chuv.ch.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.021']
960,31811674,Effect of nurse-led care on quality of care and level of HbA1C in patients with diabetic foot ulcer: A randomized clinical trial.,"Diabetic foot ulcer (DFU) is a serious and costly complication in diabetes which affects different aspects of life and can reduce patient's quality of life. Various views to manage DFU have been introduced. The nurse-led team, as a multidisciplinary team, can be effective due to a holistic approach to some disease management; but in patients with DFU it has not been assessed. Therefore, this study was designed to determine the effect of nurse-led care on quality of care (QOC) and improvement of HbA1C in Patients with DFU. This was a randomized clinical trial study performed on 52 patients with DFU. Patients were randomly assigned into two groups: nurse-led care intervention and standard care. The study was conducted in one of the hospitals affiliated to Tehran University of Medical Sciences. Data were collected using two questionnaires: Demographic characteristics and Quality Patient Care Scale (QUALPACS) and taking a blood sample for HbA1C. The nurse-led Care interventions were conducted in three stages: Integrated, Interdisciplinary, and Comprehensive. Descriptive and analytic statistical methods were used to analyze the data. P < .05 was considered significant. The results demonstrated that according to repeated measures test, (before, 4 and 12 weeks after the intervention), the level of QOC dimensions (Psychosocial, communication and physical aspect) in the nurse-led group had a significant difference with control group (P < .0001). Also, according to the results of Independent t test, there was a significant difference in total QOC scoring and HbA1c between intervention and control groups after the intervention and follow up (P < .0001). Considering the burden of diabetes and DFUs, it seems that the establishment of a nurse-led care approach can be an effective strategy to manage and treat these patients, and eliminate the disruption of care and achieve optimal care quality.",2020,"The nurse-led team, as a multidisciplinary team, can be effective due to a holistic approach to some disease management; but in patients with DFU it has not been assessed.","['Diabetic foot ulcer (DFU', 'hospitals affiliated to Tehran University of Medical Sciences', 'patients with diabetic foot ulcer', '52 patients with DFU', 'Patients with DFU']","['nurse-led care intervention and standard care', 'nurse-led care']","['Demographic characteristics and Quality Patient Care Scale (QUALPACS) and taking a blood sample for HbA1C', 'level of QOC dimensions (Psychosocial, communication and physical aspect', 'quality of care (QOC', 'quality of care and level of HbA1C', 'total QOC scoring and HbA1c']","[{'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0017313'}, {'cui': 'C0222045'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",52.0,0.0382055,"The nurse-led team, as a multidisciplinary team, can be effective due to a holistic approach to some disease management; but in patients with DFU it has not been assessed.","[{'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Dehghan Nayeri', 'Affiliation': 'School of Nursing and Midwifery, Nursing and Midwifery Care Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Samadi', 'Affiliation': 'Diabetes Researcher Center, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bagher', 'Initials': 'B', 'LastName': 'Larijani', 'Affiliation': 'School of Nursing and Midwifery, Nursing and Midwifery Care Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Sayadi', 'Affiliation': 'School of Nursing and Midwifery, Nursing and Midwifery Care Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12788']
961,25969453,An Exploratory Analysis of the Smoking and Physical Activity Outcomes From a Pilot Randomized Controlled Trial of an Exercise Assisted Reduction to Stop Smoking Intervention in Disadvantaged Groups.,"INTRODUCTION


Economically disadvantaged smokers not intending to stop may benefit from interventions aimed at reducing their smoking. This study assessed the effects of a behavioral intervention promoting an increase in physical activity versus usual care in a pilot randomized controlled trial.
METHODS


Disadvantaged smokers who wanted to reduce but not quit were randomized to either a counseling intervention of up to 12 weeks to support smoking reduction and increased physical activity (n = 49) or usual care (n = 50). Data at 16 weeks were collected for various smoking and physical activity outcomes. Primary analyses consisted of an intention to treat analysis based on complete case data. Secondary analyses explored the impact of handling missing data.
RESULTS


Compared with controls, intervention smokers were more likely to initiate a quit attempt (36 vs. 10%; odds ratio 5.05, [95% CI: 1.10; 23.15]), and a greater proportion achieved at least 50% reduction in cigarettes smoked (63 vs. 32%; 4.21 [1.32; 13.39]). Postquit abstinence measured by exhaled carbon monoxide at 4-week follow-up showed promising differences between groups (23% vs. 6%; 4.91 [0.80; 30.24]). No benefit of intervention on physical activity was found. Secondary analyses suggested that the standard missing data assumption of ""missing"" being equivalent to ""smoking"" may be conservative resulting in a reduced intervention effect.
CONCLUSIONS


A smoking reduction intervention for economically disadvantaged smokers which involved personal support to increase physical activity appears to be more effective than usual care in achieving reduction and may promote cessation. The effect does not appear to be influenced by an increase in physical activity.",2016,Postquit abstinence measured by exhaled carbon monoxide at 4-week follow-up showed promising differences between groups (23% vs. 6%; 4.91 [0.80; 30.24]).,"['Disadvantaged smokers who wanted to reduce but not quit', 'Disadvantaged Groups']","['counseling intervention of up to 12 weeks to support smoking reduction and increased physical activity (n = 49) or usual care', 'Exercise Assisted Reduction to Stop Smoking Intervention', 'behavioral intervention', 'smoking reduction intervention']","['physical activity', 'impact of handling missing data', 'Postquit abstinence', 'exhaled carbon monoxide']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4505208', 'cui_str': 'Smoking Reduction'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0018578', 'cui_str': 'Handling'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",,0.0501987,Postquit abstinence measured by exhaled carbon monoxide at 4-week follow-up showed promising differences between groups (23% vs. 6%; 4.91 [0.80; 30.24]).,"[{'ForeName': 'Tom Paul', 'Initials': 'TP', 'LastName': 'Thompson', 'Affiliation': 'Centre for Clinical Trials and Population Studies, Plymouth University Peninsula School of Medicine and Dentistry, Plymouth, United Kingdom; tom.thompson@plymouth.ac.uk.'}, {'ForeName': 'Colin J', 'Initials': 'CJ', 'LastName': 'Greaves', 'Affiliation': 'University of Exeter Medical School, Exeter, United Kingdom;'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ayres', 'Affiliation': 'Centre for Clinical Trials and Population Studies, Plymouth University Peninsula School of Medicine and Dentistry, Plymouth, United Kingdom;'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom;'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Warren', 'Affiliation': 'University of Exeter Medical School, Exeter, United Kingdom;'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Byng', 'Affiliation': 'Centre for Clinical Trials and Population Studies, Plymouth University Peninsula School of Medicine and Dentistry, Plymouth, United Kingdom;'}, {'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': 'University of Exeter Medical School, Exeter, United Kingdom;'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Campbell', 'Affiliation': 'University of Exeter Medical School, Exeter, United Kingdom;'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ussher', 'Affiliation': ""Population Health Research Institute, St George's University of London, London, United Kingdom;""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'University of Exeter Medical School, Exeter, United Kingdom;'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Michie', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, United Kingdom;'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'West', 'Affiliation': 'Health Behaviour Research Centre, Department of Epidemiology and Public Health, University College London, London, United Kingdom.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': 'Centre for Clinical Trials and Population Studies, Plymouth University Peninsula School of Medicine and Dentistry, Plymouth, United Kingdom;'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntv099']
962,31829912,Sequencing of Androgen-Deprivation Therapy With External-Beam Radiotherapy in Localized Prostate Cancer: A Phase III Randomized Controlled Trial.,"PURPOSE


Dose-escalated radiotherapy (RT) with androgen-deprivation therapy (ADT) is a standard definitive treatment of localized prostate cancer (LPCa). The optimal sequencing of these therapies is unclear. Our phase III trial compared neoadjuvant versus concurrent initiation of ADT in combination with dose-escalated prostate RT (PRT).
PATIENTS AND METHODS


Patients with newly diagnosed LPCa with Gleason score ≤ 7, clinical stage T1b to T3a, and prostate-specific antigen < 30 ng/mL were randomly allocated to neoadjuvant and concurrent ADT for 6 months starting 4 months before RT (neoadjuvant group) or concurrent and adjuvant ADT for 6 months starting simultaneously with RT (concurrent group). The primary end point was biochemical relapse-free survival (bRFS). Stratified log-rank test was used to compare bRFS and overall survival (OS). Incidence of grade ≥ 3 late RT-related toxicities was compared by log-rank test.
RESULTS


Overall, 432 patients were randomly assigned to the neoadjuvant (n = 215) or concurrent group (n = 217). At 10 years, bRFS rates for the two groups were 80.5% and 87.4%, respectively. Ten-year OS rates were 76.4% and 73.7%, respectively. There was no significant difference in bRFS ( P  = .10) or OS ( P  = .70) between the two groups. Relative to the neoadjuvant group, the hazard ratio for the concurrent group was 0.66 (95% CI, 0.41 to 1.07) for bRFS and 0.94 (95% CI, 0.68 to 1.30) for OS. No significant difference was observed in the 3-year incidence of late RT-related grade ≥ 3 GI (2.5%  v  3.9%) or genitourinary toxicity (2.9%  v  2.9%).
CONCLUSION


In our study, there was no statistically significant difference in bRFS between the two treatment groups. Similarly, no difference was seen in OS or late RT-related toxicities. On the basis of these results, both neoadjuvant and concurrent initiations of short-term ADT with dose-escalated PRT are reasonable standards of care for LPCa.",2020,There was no significant difference in bRFS ( P  = .10) or OS ( P  = .70) between the two groups.,"['Patients with newly diagnosed LPCa with Gleason score ≤ 7, clinical stage T1b to T3a, and prostate-specific antigen', 'localized prostate cancer (LPCa', 'Localized Prostate Cancer', '432 patients were randomly assigned to the neoadjuvant (n = 215) or concurrent group (n = 217']","['ADT', 'radiotherapy (RT) with androgen-deprivation therapy (ADT', 'Androgen-Deprivation Therapy With External-Beam Radiotherapy', 'RT (neoadjuvant group) or concurrent and adjuvant ADT', 'neoadjuvant and concurrent ADT']","['Incidence of grade ≥ 3 late RT-related toxicities', '3-year incidence of late RT-related grade ≥ 3 GI', 'bRFS', 'OS or late RT-related toxicities', 'bRFS and overall survival (OS', 'biochemical relapse-free survival (bRFS', 'bRFS rates', 'genitourinary toxicity', 'hazard ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3203027', 'cui_str': 'Gleason score (observable entity)'}, {'cui': 'C0205563', 'cui_str': 'Clinical staging (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517646', 'cui_str': '217'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1136355', 'cui_str': 'BRFSS'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",432.0,0.0881589,There was no significant difference in bRFS ( P  = .10) or OS ( P  = .70) between the two groups.,"[{'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Malone', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Soumyajit', 'Initials': 'S', 'LastName': 'Roy', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Libni', 'Initials': 'L', 'LastName': 'Eapen', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Choan', 'Initials': 'C', 'LastName': 'E', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'MacRae', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Gad', 'Initials': 'G', 'LastName': 'Perry', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bowen', 'Affiliation': 'Northeast Cancer Centre, Sudbury, Ontario, Canada.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Samant', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Morgan', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Craig', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Malone', 'Affiliation': 'Division of Radiation Oncology, Department of Radiology, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Grimes', 'Affiliation': 'The Ottawa Hospital Regional Cancer Center, Ottawa, Ontario, Canada.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01904']
963,31549147,Treatment Outcome of a Shorter Regimen Containing Clofazimine for Multidrug-resistant Tuberculosis: A Randomized Control Trial in China.,"BACKGROUND


The emergence of multidrug-resistant tuberculosis (MDR-TB) poses a serious obstacle to global TB control programs.
METHODS


We carried out a prospective, randomized, multicenter study in China that was focused on the potential of a shorter regimen containing clofazimine (CFZ) for the treatment of MDR-TB. There were 135 MDR-TB cases that met eligibility requirements and were randomly stratified into either the control group or experimental group. Patients in the control group received an 18-month treatment regimen, whereas patients in the experimental group received a 12-month treatment regimen containing CFZ.
RESULTS


At the completion of the treatment period, the difference in sputum-culture conversion rates between the experimental group and the control group was not significant. Notably, by the end of 3 months of treatment, 68.7% patients receiving the experimental regimen had sputum-culture conversion, as compared with 55.9% of those receiving the control regimen; this was a significant difference, suggesting an early sputum conversion (P = .04). There were 67 adverse events reported in 56 patients in this study, including 32 in the control group and 35 in the experimental group. No significant difference in the overall incidences of adverse events was observed between the 2 groups.
CONCLUSIONS


The MDR-TB patients treated with the shorter regimen containing CFZ had a comparable successful outcome rate when compared to those with the standard regimen. The patients assigned to the experimental group achieved more rapid sputum-culture conversion, reflecting superior antimicrobial activity against MDR-TB.
CLINICAL TRIALS REGISTRATION


Chinese Clinical Trial Registry ChiCTR 1800020391.",2020,"The patients assigned in the experimental group achieve more rapid sputum culture conversion, reflecting the superior antimicrobial activity against MDR-TB.","['135 MDR-TB cases met eligibility requirements', 'multidrug-resistant tuberculosis', 'MDR-TB']","['CFZ', 'clofazimine (CFZ', 'clofazimine']","['rapid sputum culture conversion', 'early sputum conversion', 'sputum-culture conversion', 'successful outcome rate', 'overall incidence of adverse events', '67 adverse events']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0206526', 'cui_str': 'Tuberculosis, Multi-Drug Resistant'}]","[{'cui': 'C0008996', 'cui_str': 'Clofazimine'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0523174', 'cui_str': 'Microbial culture of sputum (procedure)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0329544,"The patients assigned in the experimental group achieve more rapid sputum culture conversion, reflecting the superior antimicrobial activity against MDR-TB.","[{'ForeName': 'Yadong', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': ""Department of Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Qiu', 'Affiliation': ""Department of Drug-Resistant Tuberculosis, Jiamusi Tuberculosis Control Hospital, Jiamusi, People's Republic of China.""}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Tuberculosis, Fuzhou Pulmonary Hospital of Fujian, Fuzhou, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jing', 'Affiliation': ""Department of Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Hongqiu', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': ""Department of Pulmonary,The Third People's Hospital of Zhenjiang, Zhenjiang, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': ""Department of Tuberculosis, Shenyang Chest Hospital, Liaoning Province Shenyang, People's Republic of China.""}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Chest, Qingdao Chest Hospital, Qingdao, People's Republic of China.""}, {'ForeName': 'Chunxiang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Tuberculosis, Changsha Central Hospital, Changsha, People's Republic of China.""}, {'ForeName': ""Xiu'e"", 'Initials': 'X', 'LastName': 'Xi', 'Affiliation': ""Department of Tuberculosis, Xinxiang Medical College Affiliated Hospital, Xinxiang, People's Republic of China.""}, {'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': ""Clinic and Research Center of Tuberculosis, Shanghai Key Lab of Tuberculosis, Shanghai Pulmonary Hospital of Tongji University, Shanghai, People's Republic of China.""}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': ""Department of Pulmonary, The Third People's Hospital of Shenzhen, Shenzhen, People's Republic of China.""}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ""Department of Tuberculosis, Nanjing Chest Hospital, Nanjing, People's Republic of China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': ""Department of Epidemiology and Biostatistics, Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences & School of Basic Medicine, Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Qingfeng', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Guo', 'Affiliation': ""Department of Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': ""National Clinical Laboratory on Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Naihui', 'Initials': 'N', 'LastName': 'Chu', 'Affiliation': ""Department of Tuberculosis, Beijing Chest Hospital of Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz915']
964,25530107,Effect of low versus high dialysate sodium concentration on blood pressure and endothelial-derived vasoregulators during hemodialysis: a randomized crossover study.,"BACKGROUND


Intradialytic hypertension affects ∼15% of hemodialysis patients and is associated with increased morbidity and mortality. While intradialytic hypertension is associated with increases in endothelin 1 relative to nitric oxide (NO), the cause of these imbalances is unknown. In vitro evidence suggests that altering plasma sodium levels could affect endothelial-derived vasoregulators and blood pressure (BP). Thus, we hypothesized that compared to high dialysate sodium, low dialysate sodium concentration would lower endothelin 1 levels, increase NO release, and reduce BP.
STUDY DESIGN


3-week, 2-arm, randomized, crossover study.
SETTING & PARTICIPANTS


16 patients with intradialytic hypertension.
INTERVENTION


Low (5 mEq/L below serum sodium) versus high (5 mEq/L above serum sodium) dialysate sodium concentration.
OUTCOMES


Endothelin 1, nitrite (NO2(-)), and BP.
MEASUREMENTS


Mixed linear regression was used to compare the effect of dialysate sodium (low vs high) and randomization arm (low-then-high vs high-then-low) on intradialytic changes in endothelin 1, NO2(-), and BP values.
RESULTS


The average systolic BP throughout all hemodialysis treatments in a given week was lower with low dialysate sodium concentrations compared with treatments with high dialysate sodium concentrations (parameter estimate, -9.9 [95% CI, -13.3 to -6.4] mm Hg; P < 0.001). The average change in systolic BP during hemodialysis also was significantly lower with low vs high dialysate sodium concentrations (parameter estimate, -6.1 [95% CI, -9.0 to -3.2] mm Hg; P < 0.001). There were no significant differences in intradialytic levels of endothelin 1 or NO2(-) with low vs high dialysate sodium concentrations.
LIMITATIONS


Carryover effects limited the power to detect significant changes in endothelial-derived vasoregulators, and future studies will require parallel trial designs.
CONCLUSIONS


Low dialysate sodium concentrations significantly decreased systolic BP and ameliorated intradialytic hypertension. Longer studies are needed to determine the long-term effects of low dialysate sodium concentrations on BP and clinical outcomes.",2015,"There were no significant differences in intradialytic levels of endothelin 1 or NO2(-) with low vs high dialysate sodium concentrations.
","['16 patients with intradialytic hypertension', 'hemodialysis patients', 'during hemodialysis']",['low versus high dialysate sodium concentration'],"['NO release, and reduce BP', 'average systolic BP', 'morbidity and mortality', 'systolic BP and ameliorated intradialytic hypertension', 'intradialytic changes in endothelin 1, NO2(-), and BP values', 'intradialytic levels of endothelin 1 or NO2', 'blood pressure (BP', 'effect of dialysate sodium', 'systolic BP', 'Endothelin 1, nitrite (NO2(-)), and BP', 'blood pressure and endothelial-derived vasoregulators']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}]",16.0,0.0334566,"There were no significant differences in intradialytic levels of endothelin 1 or NO2(-) with low vs high dialysate sodium concentrations.
","[{'ForeName': 'Jula K', 'Initials': 'JK', 'LastName': 'Inrig', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX; Department of Internal Medicine, Duke University, Durham, NC; Department of Medicine, Quintiles Global Clinical Research Organization, Morrisville, NC. Electronic address: jula.inrig@duke.edu.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Molina', 'Affiliation': 'School of Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': ""D'Silva"", 'Affiliation': 'School of Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Buren', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Allen', 'Affiliation': 'Department of Internal Medicine, Duke University, Durham, NC.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Toto', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2014.10.021']
965,32424430,"A randomized phase III study comparing continuation and discontinuation of PD-1 pathway inhibitors for patients with advanced non-small-cell lung cancer (JCOG1701, SAVE study).","The development of PD-1 pathway inhibitors has dramatically altered the treatment of advanced/recurrent non-small-cell lung cancer patients. However, the prognostic significance of their ongoing usage is controversial, especially for patients who have not progressed for a period of time. If discontinuation has no negative impact on survival, suspension may reduce side effects from toxicity and help alleviate the economic burdens on health insurance systems and patients. This randomized controlled trial enrolls patients who have responded well to PD-1 pathway inhibitors for >12 months. The aim is to confirm the non-inferiority of discontinuation of PD-1 pathway inhibitors, relative to continuation, in terms of overall survival. A total of 216 patients will be enrolled over 3 years. This trial has been registered in the Japan Registry for Clinical Trials as jRCT1031190032 (https://jrct.niph.go.jp/). An ancillary study examining the prognostic and predictive role of circulating tumor DNA using Guardant360® is planned.",2020,"If discontinuation has no negative impact on survival, suspension may reduce side effects from toxicity and help alleviate the economic burdens on health insurance systems and patients.","['advanced/recurrent non-small-cell lung cancer patients', 'patients who have not progressed for a period of time', '216 patients will be enrolled over 3\xa0years', 'patients who have responded well to PD-1 pathway inhibitors for >12\xa0months', 'patients with advanced non-small-cell lung cancer (JCOG1701, SAVE study']",['PD-1 pathway inhibitors'],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278517', 'cui_str': 'Non-small cell lung cancer recurrent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}]",[],216.0,0.103545,"If discontinuation has no negative impact on survival, suspension may reduce side effects from toxicity and help alleviate the economic burdens on health insurance systems and patients.","[{'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Nomura', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Goto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Mizutani', 'Affiliation': 'Department of Medical Oncology, Kyorin University Faculty of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kataoka', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Kawai', 'Affiliation': 'Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Okuma', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Haruyasu', 'Initials': 'H', 'LastName': 'Murakami', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Sunto-gun, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ohe', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}]",Japanese journal of clinical oncology,['10.1093/jjco/hyaa054']
966,32424445,Cosmetic outcomes and patient satisfaction compared between staples and subcuticular suture technique for wound closure after primary total knee arthroplasty: a randomized controlled trial.,"INTRODUCTION


Staples and subcuticular suture are commonly used wound closure techniques after total knee arthroplasty (TKA). To date, only a few studies have investigated the differences between these two wound closure methods in TKA. Accordingly, this study aimed to compare cosmetic outcome and patient satisfaction between staples and subcuticular suture for post-TKA wound closure.
MATERIALS AND METHODS


This prospective randomized controlled trial included patients scheduled to undergo TKA at the Department of Orthopaedic Surgery of Siriraj Hospital (Bangkok, Thailand) during June 2018-March 2019. Patients were randomized into the staples or subcuticular suture groups. Hollander Wound Evaluation Scale (HWES), cosmetic-visual analogue scale (VAS), and patient satisfaction-VAS were evaluated at the 6-week and 3-month follow-ups. Functional outcome by the modified Knee Society Knee Scoring System and wound complications were also assessed.
RESULTS


Sixty-two patients (31 per group) were included. There were no significant differences in the HWES, cosmetic-VAS, patient satisfaction-VAS, or wound complication rate between groups at the 6-week or 3-month follow-ups. Wound closure time was significantly shorter in the staples group (p < 0.001), but the total operative time was not significantly different between groups. Modified knee score was significantly better in the suture group at 6 weeks (p = 0.024), but there was no significant difference between groups at 3 months. Significant association was observed between patient satisfaction-VAS and cosmetic-VAS at the 6-week (p = 0.03) and 3-month (p = 0.021) follow-ups.
CONCLUSION


Subcuticular suture and staples were found to be comparable wound-closure options after TKA relative to cosmetic outcome, patient satisfaction, functional outcome, and wound complication rate at 3-months post-operation.",2020,"There were no significant differences in the HWES, cosmetic-VAS, patient satisfaction-VAS, or wound complication rate between groups at the 6-week or 3-month follow-ups.","['primary total knee arthroplasty', 'patients scheduled to undergo TKA at the Department of Orthopaedic Surgery of Siriraj Hospital (Bangkok, Thailand)\xa0during June 2018-March 2019', 'Sixty-two patients (31 per group) were included']","['Staples and subcuticular suture', 'staples and subcuticular suture technique', 'staples or subcuticular suture groups']","['patient satisfaction-VAS and cosmetic-VAS', 'Cosmetic outcomes and patient satisfaction', 'HWES, cosmetic-VAS, patient satisfaction-VAS, or wound complication rate', 'Hollander Wound Evaluation Scale (HWES), cosmetic-visual analogue scale (VAS), and patient satisfaction-VAS', 'patient satisfaction, functional outcome, and wound complication rate', 'modified Knee Society Knee Scoring System and wound complications', 'total operative time', 'Modified knee score', 'cosmetic outcome and patient satisfaction', 'Wound closure time']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0563304', 'cui_str': 'Subcuticular'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0038968', 'cui_str': 'Suturing techniques'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0524633,"There were no significant differences in the HWES, cosmetic-VAS, patient satisfaction-VAS, or wound complication rate between groups at the 6-week or 3-month follow-ups.","[{'ForeName': 'Sarthak', 'Initials': 'S', 'LastName': 'Nepal', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wang Lang Road, Bangkok Noi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Pakpoom', 'Initials': 'P', 'LastName': 'Ruangsomboon', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wang Lang Road, Bangkok Noi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Pacharapol', 'Initials': 'P', 'LastName': 'Udomkiat', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wang Lang Road, Bangkok Noi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Aasis', 'Initials': 'A', 'LastName': 'Unnanuntana', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wang Lang Road, Bangkok Noi, Bangkok, 10700, Thailand. uaasis@gmail.com.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03479-3']
967,25254902,A randomized control trial of bupivacaine and fentanyl versus fentanyl-only for epidural analgesia during the second stage of labor.,"BACKGROUND


The purpose of this prospective, double-blinded, parallel-arm, randomized trial was to examine the effects of epidural bupivacaine on the length of the second stage of labor in nulliparous women.
METHODS


The authors assessed length of second-stage labor, degree of motor blockade, mode of delivery, and visual analog scores in 310 nulliparous women with labor epidurals randomized to receive either: (1) 0.125% bupivacaine and fentanyl 2 μg/ml or (2) fentanyl 10 μg/ml alone via epidural using double blinding.
RESULTS


The median duration of the second stage was 75 min (41, 128) in the bupivacaine/fentanyl group versus 73 min (42, 120) in the fentanyl-only group (P = 0.17) with a median difference of 6.0 (95% CI, -6.0 to 18.0). Furthermore, there was no difference in degree of motor blockade, incidence of operative delivery, visual analog scores, or neonatal outcomes between the two groups. No adverse events were reported.
CONCLUSIONS


Use of epidural bupivacaine/fentanyl or a fentanyl-only infusion during the second stage of labor did not affect the duration of the second stage of labor, degree of motor blockade, mode of delivery, pain relief, and maternal or neonatal outcomes. However, in the fentanyl-only infusion group, there was a fivefold increase in opioid exposure to the fetus with unknown effects on neurobehavior, an outcome not assessed beyond the immediate postnatal period in this study.",2015,"Furthermore, there was no difference in degree of motor blockade, incidence of operative delivery, visual analog scores, or neonatal outcomes between the two groups.","['310 nulliparous women with labor epidurals', 'epidural analgesia during the second stage of labor', 'nulliparous women']","['bupivacaine and fentanyl 2 μg/ml or (2) fentanyl 10 μg/ml alone via epidural using double blinding', 'bupivacaine and fentanyl', 'epidural bupivacaine/fentanyl', 'epidural bupivacaine', 'bupivacaine/fentanyl']","['degree of motor blockade, incidence of operative delivery, visual analog scores, or neonatal outcomes', 'duration of the second stage of labor, degree of motor blockade, mode of delivery, pain relief, and maternal or neonatal outcomes', 'adverse events', 'median duration of the second stage', 'length of second-stage labor, degree of motor blockade, mode of delivery, and visual analog scores']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0022872', 'cui_str': 'Labor Stage, Second'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0592511', 'cui_str': 'Epidural use'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0022872', 'cui_str': 'Labor Stage, Second'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",310.0,0.115272,"Furthermore, there was no difference in degree of motor blockade, incidence of operative delivery, visual analog scores, or neonatal outcomes between the two groups.","[{'ForeName': 'Margaret G', 'Initials': 'MG', 'LastName': 'Craig', 'Affiliation': 'From the Department of Anesthesiology and Pain Management (M.G.C., E.N.G., W.T.) and Department of Obstetrics and Gynecology (D.D.M., K.J.L.), The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Grant', 'Affiliation': ''}, {'ForeName': 'Weike', 'Initials': 'W', 'LastName': 'Tao', 'Affiliation': ''}, {'ForeName': 'Donald D', 'Initials': 'DD', 'LastName': 'McIntire', 'Affiliation': ''}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Leveno', 'Affiliation': ''}]",Anesthesiology,['10.1097/ALN.0000000000000454']
968,31104490,"Automated Feedback Messages With Shichifukujin Characters Using IoT System-Improved Glycemic Control in People With Diabetes: A Prospective, Multicenter Randomized Controlled Trial.",,2019,,['People With Diabetes'],"['Automated Feedback Messages', 'Shichifukujin Characters Using IoT System-Improved Glycemic Control']",[],[],"[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.151882,,"[{'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': '1 Department of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Kazuyo', 'Initials': 'K', 'LastName': 'Tsushita', 'Affiliation': '2 Comprehensive Health Science Center, Aichi Health Promotion Public Interest Foundation, Aichi, Japan.'}, {'ForeName': 'Eri', 'Initials': 'E', 'LastName': 'Nomura', 'Affiliation': '2 Comprehensive Health Science Center, Aichi Health Promotion Public Interest Foundation, Aichi, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Muramoto', 'Affiliation': '2 Comprehensive Health Science Center, Aichi Health Promotion Public Interest Foundation, Aichi, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Kato', 'Affiliation': '2 Comprehensive Health Science Center, Aichi Health Promotion Public Interest Foundation, Aichi, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Eguchi', 'Affiliation': '2 Comprehensive Health Science Center, Aichi Health Promotion Public Interest Foundation, Aichi, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Onoue', 'Affiliation': '1 Department of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Motomitsu', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': '1 Department of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Shigeki', 'Initials': 'S', 'LastName': 'Muto', 'Affiliation': '3 Seirei Center for Health Promotion and Preventive Medicine, Shizuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yatsuya', 'Affiliation': '4 Department of Public Health, Fujita health University School of Medicine, Aichi, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Arima', 'Affiliation': '1 Department of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}]",Journal of diabetes science and technology,['10.1177/1932296819851785']
969,25243839,Lactulose vs polyethylene glycol 3350--electrolyte solution for treatment of overt hepatic encephalopathy: the HELP randomized clinical trial.,"IMPORTANCE


Hepatic encephalopathy (HE) is a common cause of hospitalization in patients with cirrhosis. Pharmacologic treatment for acute (overt) HE has remained the same for decades.
OBJECTIVE


To compare polyethylene glycol 3350-electrolyte solution (PEG) and lactulose treatments in patients with cirrhosis admitted to the hospital for HE. We hypothesized that rapid catharsis of the gut using PEG may resolve HE more effectively than lactulose.
DESIGN, SETTING, AND PARTICIPANTS


The HELP (Hepatic Encephalopathy: Lactulose vs Polyethylene Glycol 3350-Electrolyte Solution) study is a randomized clinical trial in an academic tertiary hospital of 50 patients with cirrhosis (of 186 screened) admitted for HE.
INTERVENTIONS


Participants were block randomized to receive treatment with PEG, 4-L dose (n = 25), or standard-of-care lactulose (n = 25) during hospitalization.
MAIN OUTCOMES AND MEASURES


The primary end point was an improvement of 1 or more in HE grade at 24 hours, determined using the hepatic encephalopathy scoring algorithm (HESA), ranging from 0 (normal clinical and neuropsychological assessments) to 4 (coma). Secondary outcomes included time to HE resolution and overall length of stay.
RESULTS


A total of 25 patients were randomized to each treatment arm. Baseline clinical features at admission were similar in the groups. Thirteen of 25 patients in the standard therapy arm (52%) had an improvement of 1 or more in HESA score, thus meeting the primary outcome measure, compared with 21 of 23 evaluated patients receiving PEG (91%) (P < .01); 1 patient was discharged before final analysis and 1 refused participation. The mean (SD) HESA score at 24 hours for patients receiving standard therapy changed from 2.3 (0.9) to 1.6 (0.9) compared with a change from 2.3 (0.9) to 0.9 (1.0) for the PEG-treated groups (P = .002). The median time for HE resolution was 2 days for standard therapy and 1 day for PEG (P = .01). Adverse events were uncommon, and none was definitely study related.
CONCLUSIONS AND RELEVANCE


PEG led to more rapid HE resolution than standard therapy, suggesting that PEG may be superior to standard lactulose therapy in patients with cirrhosis hospitalized for acute HE.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT01283152.",2014,The median time for HE resolution was 2 days for standard therapy and 1 day for PEG (P = .01).,"['patients with cirrhosis', 'patients with cirrhosis hospitalized for acute HE', 'overt hepatic encephalopathy', '50 patients with cirrhosis (of 186 screened) admitted for HE', 'patients with cirrhosis admitted to the hospital for HE', '25 patients']","['Hepatic Encephalopathy: Lactulose vs Polyethylene Glycol 3350-Electrolyte Solution', 'polyethylene glycol 3350-electrolyte solution (PEG) and lactulose treatments', 'PEG, 4-L dose (n\u2009=\u200925), or standard-of-care lactulose', 'Lactulose vs polyethylene glycol 3350--electrolyte solution']","['median time for HE resolution', 'Adverse events', 'mean (SD) HESA score', 'time to HE resolution and overall length of stay', 'improvement of 1 or more in HE grade at 24 hours, determined using the hepatic encephalopathy scoring algorithm (HESA), ranging from 0 (normal clinical and neuropsychological assessments) to 4 (coma', 'improvement of 1 or more in HESA score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0724672', 'cui_str': 'POLYETHYLENE GLYCOL 3350'}, {'cui': 'C3541941', 'cui_str': 'Electrolyte solutions'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}, {'cui': 'C0002045'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}]",25.0,0.236335,The median time for HE resolution was 2 days for standard therapy and 1 day for PEG (P = .01).,"[{'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Rahimi', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas2Parkland Memorial Hospital, Parkland Health and Hospital System, Dallas, Texas3Now with Annette C. and Harold C. Simmons Transplant Institute, Baylor University Medic.'}, {'ForeName': 'Amit G', 'Initials': 'AG', 'LastName': 'Singal', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas2Parkland Memorial Hospital, Parkland Health and Hospital System, Dallas, Texas4Department of Clinical Science, University of Texas Southwestern Medical Center, Dallas.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Cuthbert', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas2Parkland Memorial Hospital, Parkland Health and Hospital System, Dallas, Texas.'}, {'ForeName': 'Don C', 'Initials': 'DC', 'LastName': 'Rockey', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas2Parkland Memorial Hospital, Parkland Health and Hospital System, Dallas, Texas5Now with Department of Internal Medicine, Medical University of South Carolina, Charles.'}]",JAMA internal medicine,['10.1001/jamainternmed.2014.4746']
970,32070302,The effect of intracanal medicaments used in Endodontics on the dislocation resistance of two calcium silicate-based filling materials.,"BACKGROUND


Intracanal medicaments can be used in various endodontic conditions including multiple visit endodontics after trauma or in regenerative endodontics. These medicaments should be removed from the root canal before the placement of the filling or repair material. The aim of the present study was to evaluate the effect of prior calcium hydroxide (Ca(OH) 2 ) and modified triple antibiotic paste (mTAP) placement on the push-out bond strength of TotalFill BC fast set putty (BC fast set putty) to root dentin when compared to mineral trioxide aggregate (MTA).
METHODS


The root canals of 45 extracted mandibular premolars were prepared to a standardized internal diameter (1.5 mm). The specimens were randomly assigned to 3 groups according to the intracanal medicament used: mTAP (a mixture of metronidazole, ciprofloxacin, and cefaclor), Ca(OH) 2 , and no intracanal medicament. After 1 week, the medicaments were removed, and the middle third of the roots were cut into two transverse sections (2.0 ± 0.05) (n = 90 slices). Thereafter, the specimens were divided into two subgroups (n = 45 each): MTA or BC putty. After 1 week, the push-out test was performed and failure mode was evaluated. The data were statistically analyzed using two-way ANOVA and Tukey's post hoc.
RESULTS


The application of the intracanal medicament did not significantly affect the bond strength of BC putty (p > .05). For MTA, the prior application of Ca(OH) 2  or mTAP significantly decreased the dislocation resistance (p < .05). Specimens in the MTA subgroups showed an almost equal number of cohesive and mixed types of failure while the majority of the specimens in the BC putty subgroups revealed the cohesive type.
CONCLUSIONS


Ca(OH) 2  and mTAP promoted lower bond strength of MTA to root dentin compared to the control group. However, the BC fast set putty bond strength to dentin was not affected by prior medication with Ca(OH) 2  or mTAP.",2020,"CONCLUSIONS


Ca(OH) 2  and mTAP promoted lower bond strength of MTA to root dentin compared to the control group.",['45 extracted mandibular premolars'],"['mTAP (a mixture of metronidazole, ciprofloxacin, and cefaclor), Ca(OH) 2 , and no intracanal medicament', 'calcium hydroxide (Ca(OH) 2 ) and modified triple antibiotic paste (mTAP) placement', 'intracanal medicaments']","['bond strength of BC putty', 'bond strength of MTA to root dentin', 'dislocation resistance']","[{'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}]","[{'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0007537', 'cui_str': 'Cefaclor'}, {'cui': 'C0456386', 'cui_str': 'Medicament (attribute)'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]","[{'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}]",,0.0181054,"CONCLUSIONS


Ca(OH) 2  and mTAP promoted lower bond strength of MTA to root dentin compared to the control group.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Alsubait', 'Affiliation': 'Division of Endodontics, Department of Restorative Dental Science, College of Dentistry, King Saud University, Riyadh, Saudi Arabia. salsubait@ksu.edu.sa.'}, {'ForeName': 'Norah', 'Initials': 'N', 'LastName': 'Alsaad', 'Affiliation': 'Private Practice, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sumayyah', 'Initials': 'S', 'LastName': 'Alahmari', 'Affiliation': 'Endodontic Residency Program, Saudi Commission for Health Specialist, Riyadh, Saudi Arabia.'}, {'ForeName': 'Fatimah', 'Initials': 'F', 'LastName': 'Alfaraj', 'Affiliation': 'Private Practice, Riyadh, Saudi Arabia.'}, {'ForeName': 'Hussam', 'Initials': 'H', 'LastName': 'Alfawaz', 'Affiliation': 'Division of Endodontics, Department of Restorative Dental Science, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Alqedairi', 'Affiliation': 'Division of Endodontics, Department of Restorative Dental Science, College of Dentistry, King Saud University, Riyadh, Saudi Arabia.'}]",BMC oral health,['10.1186/s12903-020-1044-6']
971,23137508,Biomarkers in acutely decompensated heart failure with preserved or reduced ejection fraction.,"BACKGROUND


Acute decompensated heart failure (ADHF) occurs with preserved (heart failure with preserved ejection fraction [HFpEF] ≥50%) or reduced (heart failure with reduced ejection fraction [HFrEF] <50%) ejection fraction. Natriuretic peptide (NP) levels are lower in HFpEF than HFrEF. We hypothesized that lower NP levels in HFpEF may be associated with other differences in biomarkers, specifically, renin-angiotensin-aldosterone system (RAAS) activation, oxidative stress, and a biomarker that reflects collagen synthesis.
METHODS


In this prespecified ancillary analysis of patients with ADHF enrolled in the Diuretic Optimization Strategies Evaluation study, clinical features and N-terminal pro-B-type NP, cystatin C, plasma renin activity, aldosterone, oxidative stress (uric acid), and procollagen type III N-terminal peptide were compared in HFpEF and HFrEF at enrollment and 60-day follow-up.
RESULTS


Compared with HFrEF (n = 219), HFpEF (n = 81) patients were older, heavier, more commonly female, less treated with RAAS antagonists, but with similar New York Heart Association class, jugular venous pressure, and edema severity. N-terminal pro-B-type NP was lower, and systolic blood pressure and cystatin C were higher in HFpEF. Despite higher systolic blood pressure and less RAAS antagonist use in HFpEF, plasma renin activity and aldosterone levels were similar in HFpEF and HFrEF as were uric acid and procollagen type III N-terminal peptide levels. Changes in biomarker levels from enrollment to 60 days were similar between HFrEF (n = 149) and HFpEF (n = 50).
CONCLUSION


Lower NP levels in decompensated HFpEF occur in association with similar ADHF severity, more impaired vascular and renal function but similar elevation of biomarkers that reflect RAAS activation, oxidative stress, and collagen synthesis as in HFrEF.",2012,"N-terminal pro-B-type NP was lower, and systolic blood pressure and cystatin C were higher in HFpEF.","['acutely decompensated heart failure with preserved or reduced ejection fraction', 'patients with ADHF enrolled']","['HFpEF', 'HFrEF']","['Natriuretic peptide (NP) levels', 'systolic blood pressure and cystatin C', 'New York Heart Association class, jugular venous pressure, and edema severity', 'clinical features and N-terminal pro-B-type NP, cystatin C, plasma renin activity, aldosterone, oxidative stress (uric acid), and procollagen type III N-terminal peptide', 'systolic blood pressure and less RAAS antagonist use in HFpEF, plasma renin activity and aldosterone levels']","[{'cui': 'C0205434', 'cui_str': 'Decompensated (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1609524', 'cui_str': 'Acute decompensated heart failure'}]",[],"[{'cui': 'C1144709', 'cui_str': 'Natriuretic Peptides'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0428897', 'cui_str': 'Jugular venous pressure (observable entity)'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C2242770', 'cui_str': 'B-type NP'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0035094', 'cui_str': 'Angiotensinogenase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0072054', 'cui_str': 'PCP III'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",81.0,0.0359154,"N-terminal pro-B-type NP was lower, and systolic blood pressure and cystatin C were higher in HFpEF.","[{'ForeName': 'Kalkidan', 'Initials': 'K', 'LastName': 'Bishu', 'Affiliation': 'Mayo Clinic, Rochester, MN 55905, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Deswal', 'Affiliation': ''}, {'ForeName': 'Horng H', 'Initials': 'HH', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Martin M', 'Initials': 'MM', 'LastName': 'LeWinter', 'Affiliation': ''}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Semigran', 'Affiliation': ''}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Borlaug', 'Affiliation': ''}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'McNulty', 'Affiliation': ''}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': ''}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ''}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2012.08.014']
972,24162898,Impact of atrial fibrillation on exercise capacity in heart failure with preserved ejection fraction: a RELAX trial ancillary study.,"BACKGROUND


Atrial fibrillation (AF) is common among patients with heart failure and preserved ejection fraction (HFpEF), but its clinical profile and impact on exercise capacity remain unclear. RELAX (Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in HFpEF) was a multicenter randomized trial testing the impact of sildenafil on peak VO2 in stable outpatients with chronic HFpEF. We sought to compare clinical features and exercise capacity among patients with HFpEF who were in sinus rhythm (SR) or AF.
METHODS AND RESULTS


RELAX enrolled 216 patients with HFpEF, of whom 79 (37%) were in AF, 124 (57%) in SR, and 13 in other rhythms. Participants underwent baseline cardiopulmonary exercise testing, echocardiogram, biomarker assessment, and rhythm status assessment before randomization. Patients with AF were older than those in SR but had similar symptom severity, comorbidities, and renal function. β-blocker use and chronotropic indices were also similar. Despite comparable left ventricular size and mass, AF was associated with worse systolic (lower EF, stroke volume, and cardiac index) and diastolic (shorter deceleration time and larger left atria) function compared with SR. Pulmonary artery systolic pressure was higher in AF. Patients with AF had higher N-terminal pro-B-type natriuretic peptide, aldosterone, endothelin-1, troponin I, and C-telopeptide for type I collagen levels, suggesting more severe neurohumoral activation, myocyte necrosis, and fibrosis. Peak VO2 was lower in AF, even after adjustment for age, sex, and chronotropic response, and VE/VCO2 was higher.
CONCLUSIONS


AF identifies an HFpEF cohort with more advanced disease and significantly reduced exercise capacity. These data suggest that evaluation of the impact of different rate or rhythm control strategies on exercise tolerance in patients with HFpEF and AF is warranted.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov. Unique identifier: NCT00763867.",2014,"Patients with AF had higher N-terminal pro-B-type natriuretic peptide, aldosterone, endothelin-1, troponin I, and C-telopeptide for type","['stable outpatients with chronic HFpEF', 'RELAX enrolled 216 patients with HFpEF, of whom 79 (37%) were in AF, 124 (57%) in SR, and 13 in other rhythms', 'heart failure with preserved ejection fraction', 'patients with HFpEF who were in sinus rhythm (SR) or AF', 'patients with heart failure and preserved ejection fraction (HFpEF', 'patients with HFpEF and AF', 'Patients with AF had higher N-terminal pro-B-type natriuretic peptide, aldosterone, endothelin-1, troponin I, and C-telopeptide for type']","['RELAX (Phosphodiesterase-5 Inhibition', 'sildenafil']","['worse systolic (lower EF, stroke volume, and cardiac index) and diastolic (shorter deceleration time and larger left atria) function', 'severe neurohumoral activation, myocyte necrosis, and fibrosis', 'symptom severity, comorbidities, and renal function', 'Peak VO2', 'peak VO2', 'exercise capacity', 'Pulmonary artery systolic pressure']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0542193', 'cui_str': 'Relaxed (qualifier value)'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0373535', 'cui_str': 'Aldosterone measurement (procedure)'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0920210', 'cui_str': 'Troponin I measurement (procedure)'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0542193', 'cui_str': 'Relaxed (qualifier value)'}, {'cui': 'C0757672', 'cui_str': 'Phosphodiesterase Type 5'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}]","[{'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0596981', 'cui_str': 'Myocytes'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure (observable entity)'}]",216.0,0.051968,"Patients with AF had higher N-terminal pro-B-type natriuretic peptide, aldosterone, endothelin-1, troponin I, and C-telopeptide for type","[{'ForeName': 'Rosita', 'Initials': 'R', 'LastName': 'Zakeri', 'Affiliation': 'Division of Cardiology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Barry A', 'Initials': 'BA', 'LastName': 'Borlaug', 'Affiliation': ''}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': ''}, {'ForeName': 'Selma F', 'Initials': 'SF', 'LastName': 'Mohammed', 'Affiliation': ''}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Semigran', 'Affiliation': ''}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Deswal', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'LeWinter', 'Affiliation': ''}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': ''}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ''}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': ''}]",Circulation. Heart failure,['10.1161/CIRCHEARTFAILURE.113.000568']
973,24529619,Headache and migraine in children with sickle cell disease are associated with lower hemoglobin and higher pain event rates but not silent cerebral infarction.,"OBJECTIVE


To identify risk factors for headache and migraine in children with sickle cell disease and test the hypothesis that either or both are independently associated with silent cerebral infarcts.
STUDY DESIGN


In this cross-sectional study, we evaluated the health history, laboratory values, and brain magnetic resonance imaging findings of participants with sickle cell disease (hemoglobinSS or hemoglobinSβ°-thalassemia) with no history of overt stroke or seizures. Participants characterized headache severity and quality. Migraine was defined by International Headache Society criteria modified for increased sensitivity in children. Neuroradiology and neurology committees adjudicated the presence of silent cerebral infarction by review of magnetic resonance imaging and standardized examination by pediatric neurologists.
RESULTS


The cohort included 872 children (51.1% males), ranging in age from 5 to 15 years (mean age, 9.1 years). Of these children, 317 (36.4%) reported recurrent headaches, and 132 (15.1%) reported migraines. In multivariable logistic regression analyses, both were associated with lower steady-state hemoglobin (P = .01 for headaches; P < .01 for migraines) and higher pain rate (P < .01 for headaches; P < .01 for migraines), defined as the number of admissions requiring opioids in the previous 3 years. The presence of silent cerebral infarction was not associated with recurrent headaches or migraines. Only 1.9% (6 of 317) of children with recurrent headaches received medication for headache prophylaxis.
CONCLUSION


Recurrent headaches and migraines are common and undertreated in children with sickle cell disease. Low hemoglobin levels and high pain rates are associated with recurrent headaches and migraines; whereas, silent cerebral infarction is not.",2014,"In multivariable logistic regression analyses, both were associated with lower steady-state hemoglobin (P = .01 for headaches; P < .01 for migraines) and higher pain rate (P < .01 for headaches; P < .01 for migraines), defined as the number of admissions requiring opioids in the previous 3 years.","['children with sickle cell disease', 'participants with sickle cell disease (hemoglobinSS or hemoglobinSβ°-thalassemia) with no history of overt stroke or seizures', '872 children (51.1% males), ranging in age from 5 to 15 years (mean age, 9.1 years']",[],"['pain rate', 'steady-state hemoglobin', 'Low hemoglobin levels and high pain rates', 'Headache and migraine', 'recurrent headaches', 'migraines', 'headache severity and quality']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",872.0,0.0251261,"In multivariable logistic regression analyses, both were associated with lower steady-state hemoglobin (P = .01 for headaches; P < .01 for migraines) and higher pain rate (P < .01 for headaches; P < .01 for migraines), defined as the number of admissions requiring opioids in the previous 3 years.","[{'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Dowling', 'Affiliation': 'Department of Pediatrics and Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Noetzel', 'Affiliation': ""Department of Neurology, Division of Pediatric and Developmental Neurology, St Louis Children's Hospital and Washington University School of Medicine, St Louis, MO.""}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Rodeghier', 'Affiliation': 'Rodeghier Consultants, Chicago, IL.'}, {'ForeName': 'Charles T', 'Initials': 'CT', 'LastName': 'Quinn', 'Affiliation': ""Division of Hematology, Cancer and Blood Diseases Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Deborah G', 'Initials': 'DG', 'LastName': 'Hirtz', 'Affiliation': 'National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Rebecca N', 'Initials': 'RN', 'LastName': 'Ichord', 'Affiliation': ""Department of Neurology and Pediatrics, The Children's Hospital of Philadelphia and Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Kwiatkowski', 'Affiliation': ""Department of Neurology and Pediatrics, The Children's Hospital of Philadelphia and Perelman School of Medicine of the University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'E Steven', 'Initials': 'ES', 'LastName': 'Roach', 'Affiliation': 'Division of Child Neurology, Ohio State College of Medicine, Columbus, OH.'}, {'ForeName': 'Fenella J', 'Initials': 'FJ', 'LastName': 'Kirkham', 'Affiliation': 'Neurosciences Unit, Institute of Child Health, University College London, London, United Kingdom.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Casella', 'Affiliation': 'Division of Pediatric Hematology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'DeBaun', 'Affiliation': 'Department of Pediatrics Vanderbilt-Meharry-Matthew Walker Center of Excellence in Sickle Cell Disease, Vanderbilt University School of Medicine, Nashville, TN. Electronic address: m.debaun@vanderbilt.edu.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2014.01.001']
974,24484541,Targeted rehabilitation to improve outcome after total knee replacement (TRIO): study protocol for a randomised controlled trial.,"BACKGROUND


Approximately 20% of patients are not satisfied with the outcome of total knee replacement, great volumes of which are carried out yearly. Physiotherapy is often provided by the NHS to address dysfunction following knee replacement; however the efficacy of this is unknown. Although clinically it is accepted that therapy is useful, provision of physiotherapy to all patients post-operatively does not enhance outcomes at one year. No study has previously assessed the effect of targeting therapy to individuals struggling to recover in the early post-operative phase.The aim of the TRIO study is to determine whether stratifying care by targeting physiotherapy to those individuals performing poorly following knee replacement is effective in improving the one year outcomes. We are also investigating whether the structure of the physiotherapy provision itself influences outcomes.
METHODS/DESIGN


The study is a multi-centre prospective randomised controlled trial (RCT) of patients undergoing primary total knee replacement, with treatment targeted at those deemed most susceptible to gain from it. Use of the national PROMS programme for pre-operative data collection allows us to screen all patients at initial post-operative clinical review, and recruit only those deemed to be recovering slowly.We aim to recruit 440 patients through various NHS orthopaedic centres who will undergo six weeks of physiotherapy. The intervention will be either 'intensive' involving both hospital and home-based functional exercise rehabilitation, or 'standard of care' consisting of home exercises. Patients will be randomised to either group using a web-based system. Both groups will receive pre and post-intervention physiotherapy review. Patients will be followed-up to one year post-operation. The primary outcome measure is the Oxford Knee Score. Secondary outcomes are patient satisfaction, functional ability, pain scores and cost-effectiveness.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN23357609. ClinicalTrials.gov NCT01849445.",2014,No study has previously assessed the effect of targeting therapy to individuals struggling to recover in the early post-operative phase.,"['patients undergoing primary total knee replacement, with treatment targeted at those deemed most susceptible to gain from it', '440 patients through various NHS orthopaedic centres who will undergo six weeks of physiotherapy']","[""intensive' involving both hospital and home-based functional exercise rehabilitation, or 'standard of care' consisting of home exercises""]","['patient satisfaction, functional ability, pain scores and cost-effectiveness', 'Oxford Knee Score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises (regime/therapy)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score (observable entity)'}]",440.0,0.16922,No study has previously assessed the effect of targeting therapy to individuals struggling to recover in the early post-operative phase.,"[{'ForeName': 'A Hamish R W', 'Initials': 'AH', 'LastName': 'Simpson', 'Affiliation': 'Department of Trauma and Orthopaedics, University of Edinburgh, Edinburgh EH16 4SB, UK. hamish.simpson@ed.ac.uk.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Hamilton', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Beard', 'Affiliation': ''}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Barker', 'Affiliation': ''}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Wilton', 'Affiliation': ''}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Hutchison', 'Affiliation': ''}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Tuck', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Stoddard', 'Affiliation': ''}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Macfarlane', 'Affiliation': ''}, {'ForeName': 'Gordon D', 'Initials': 'GD', 'LastName': 'Murray', 'Affiliation': ''}]",Trials,['10.1186/1745-6215-15-44']
975,25039577,Assessment of the efficacy of the utilisation of conventional and electric toothbrushes by the older adults.,"OBJECTIVE


To evaluate the efficacy of electric and conventional toothbrushes for a group of elderly individuals.
BACKGROUND


Although the electric toothbrush has been recommended for elderly individuals, there had previously never been a study regarding its efficacy.
MATERIAL AND METHODS


Sixty independent elders of both genders with different oral conditions from the Center Adult Day Vitória, Espírito Santo, Brazil, were randomly divided into two groups of 30 individuals. One group received the Oral B CrossAction Power electric toothbrush, whereas the other received a conventional Bitufo Class 32 soft toothbrush to perform oral hygiene. The bacterial plaque index (O'Leary Plaque Index) and DMFT index were assessed as a measure of oral hygiene and oral health. The data were analysed using the Shapiro-Wilk, Mann-Whitney and Wilcoxon tests.
RESULTS


The results of the efficacy of the Oral B Cross Action Power electric toothbrush demonstrated that on the 7th and 15th days, the bacterial plaque indexes were 24.91 ± 12.81 and 22.11 ± 14.46, respectively, which corresponds to a 50.24% removal of bacterial plaque on the 7th and 55.83% on the 15th days. Although the electric toothbrush removed more bacterial plaque than the conventional toothbrush, the difference was not statistically significant.
CONCLUSION


Both the conventional and the electric toothbrushes were effective in removing bacterial plaque within the elderly group. More studies are necessary to test the efficacy of electric toothbrushes in relation to conventional toothbrushes for elderly patients.",2020,"Although the electric toothbrush removed more bacterial plaque than the conventional toothbrush, the difference was not statistically significant.","['elderly individuals', 'elderly patients', 'Sixty independent elders of both genders with different oral conditions from the Center Adult Day Vitória, Espírito Santo, Brazil']","['electric toothbrush', 'conventional and electric toothbrushes', 'electric toothbrushes', 'Oral B Cross Action Power electric toothbrush', 'Oral B CrossAction Power electric toothbrush', 'electric and conventional toothbrushes']","['bacterial plaque', 'bacterial plaque indexes', ""bacterial plaque index (O'Leary Plaque Index) and DMFT index""]","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush, device (physical object)'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0115077,"Although the electric toothbrush removed more bacterial plaque than the conventional toothbrush, the difference was not statistically significant.","[{'ForeName': 'Cristiane V C', 'Initials': 'CVC', 'LastName': 'Nobre', 'Affiliation': 'Federal University of Espirito Santo, Centro Biomédico, Avenida Marechal Campos, 1468, Maruipe, CEP 29043-900, Vitoeria, ES, Brasil.'}, {'ForeName': 'Ana M M', 'Initials': 'AMM', 'LastName': 'Gomes', 'Affiliation': 'Federal University of Espirito Santo, Centro Biomédico, Avenida Marechal Campos, 1468, Maruipe, CEP 29043-900, Vitoeria, ES, Brasil.'}, {'ForeName': 'Ana P M', 'Initials': 'APM', 'LastName': 'Gomes', 'Affiliation': 'Federal University of Espirito Santo, Centro Biomédico, Avenida Marechal Campos, 1468, Maruipe, CEP 29043-900, Vitoeria, ES, Brasil.'}, {'ForeName': 'Antonio A', 'Initials': 'AA', 'LastName': 'Gomes', 'Affiliation': 'Federal University of Espirito Santo, Centro Biomédico, Avenida Marechal Campos, 1468, Maruipe, CEP 29043-900, Vitoeria, ES, Brasil.'}, {'ForeName': 'Ana P C', 'Initials': 'APC', 'LastName': 'Nascimento', 'Affiliation': 'Federal University of Espirito Santo, Centro Biomédico, Avenida Marechal Campos, 1468, Maruipe, CEP 29043-900, Vitoeria, ES, Brasil.'}]",Gerodontology,['10.1111/j.1741-2358.2012.00635.x']
976,23644038,Differential change in specific depressive symptoms during antidepressant medication or cognitive therapy.,"Cognitive therapy and antidepressant medications are effective treatments for depression, but little is known about their relative efficacy in reducing individual depressive symptoms. Using data from a recent clinical trial comparing cognitive therapy, antidepressant medication, and placebo in the treatment of moderate-to-severe depression, we examined whether there was a relative advantage of any treatment in reducing the severity of specific depressive symptom clusters. The sample consisted of 231 depressed outpatients randomly assigned to: cognitive therapy for 16 weeks (n = 58); paroxetine treatment for 16 weeks (n = 116); or pill placebo for 8 weeks (n = 57). Differential change in five subsets of depressive symptoms was examined: mood, cognitive/suicide, anxiety, typical-vegetative, and atypical-vegetative symptoms. Medication led to a greater reduction in cognitive/suicide symptoms relative to placebo by 4 weeks, and both active treatments reduced these symptoms more than did placebo by 8 weeks. Cognitive therapy reduced the atypical-vegetative symptoms more than placebo by 8 weeks and more than medications throughout the trial. These findings suggest that medications and cognitive therapy led to different patterns of response to specific symptoms of depression and that the general efficacy of these two well-validated treatments may be driven in large part by changes in cognitive or atypical-vegetative symptoms.",2013,"Medication led to a greater reduction in cognitive/suicide symptoms relative to placebo by 4 weeks, and both active treatments reduced these symptoms more than did placebo by 8 weeks.","['moderate-to-severe depression', '231 depressed outpatients randomly assigned to']","['placebo', 'paroxetine', 'antidepressant medication or cognitive therapy', 'Cognitive therapy and antidepressant medications', 'cognitive therapy, antidepressant medication, and placebo', 'pill placebo', 'cognitive therapy', 'Cognitive therapy']","['atypical-vegetative symptoms', 'cognitive/suicide symptoms', 'specific depressive symptoms', 'mood, cognitive/suicide, anxiety, typical-vegetative, and atypical-vegetative symptoms']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}]","[{'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",231.0,0.0566911,"Medication led to a greater reduction in cognitive/suicide symptoms relative to placebo by 4 weeks, and both active treatments reduced these symptoms more than did placebo by 8 weeks.","[{'ForeName': 'Jay C', 'Initials': 'JC', 'LastName': 'Fournier', 'Affiliation': ""Department of Psychiatry, University of Pittsburgh School of Medicine, 3811 O'Hara Street, Pittsburgh, PA 15213, USA. fournierjc@upmc.edu""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'DeRubeis', 'Affiliation': ''}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Hollon', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gallop', 'Affiliation': ''}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': ''}, {'ForeName': 'Jay D', 'Initials': 'JD', 'LastName': 'Amsterdam', 'Affiliation': ''}]",Behaviour research and therapy,['10.1016/j.brat.2013.03.010']
977,32427415,"Authors' reply re: Antenatal magnesium sulphate for the prevention of cerebral palsy in infants born preterm: a double-blind, randomised, placebo-controlled, multi-centre trial: Time range for treatment with magnesium sulphate.",,2020,,"['born preterm', 'cerebral palsy in infants']","['magnesium sulphate', 'Antenatal magnesium sulphate', 'placebo']",[],"[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.770591,,"[{'ForeName': 'Hanne Trap', 'Initials': 'HT', 'LastName': 'Wolf', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Brok', 'Affiliation': 'Department of Paediatric and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Tine Brink', 'Initials': 'TB', 'LastName': 'Henriksen', 'Affiliation': 'Perinatal Epidemiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Hanne Kristine', 'Initials': 'HK', 'LastName': 'Hegaard', 'Affiliation': 'Department of Obstetrics and Gynaecology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Gorm', 'Initials': 'G', 'LastName': 'Greisen', 'Affiliation': 'Department of Neonatology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Weber', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Pryds', 'Affiliation': 'Department of Paediatrics, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Jannie Dalby', 'Initials': 'JD', 'LastName': 'Salvig', 'Affiliation': 'Department of Obstetrics and Gynaecology, Skejby University Hospital, Skejby, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Hedegaard', 'Affiliation': 'Department of Obstetrics, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Lene Drasbek', 'Initials': 'LD', 'LastName': 'Huusom', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Hvidovre, Denmark.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16267']
978,23127806,"Randomized, double-blind, placebo-controlled trial of polyethylene glycol (MiraLAX®) for urinary urge symptoms.","OBJECTIVE


Polyethylene glycol (PEG) is common first-line therapy for urinary symptoms despite minimal evidence-based support. We performed a randomized, double-blind, placebo-controlled study of PEG for initial treatment of overactive bladder (OAB) symptoms in children.
PATIENTS AND METHODS


Patients aged >3 years underwent baseline urinary symptom questionnaire (USQ, scored 0-16), bowel symptom questionnaire (scored 0-20) and abdominal X-ray (KUB). Patients were randomized to placebo/PEG regardless of parent's perception of constipation. After 1 month, patients completed follow-up questionnaires and KUB. Improvement was defined as decrease in USQ (ΔUSQ) ≥ 3 points. Secondary analyses compared urinary and bowel symptoms to KUB.
RESULTS


Of 138 enrolled patients, 71 (51.4%) completed 1 month of therapy. Analyses of those randomized to placebo vs. PEG and non-completers demonstrated similar demographics, baseline symptoms, and KUB. Patients treated with placebo and PEG both had significant improvement in USQ scores (p < 0.0001). Patients treated with placebo and PEG responded similarly to placebo (ΔUSQ 3.7 vs. 3.4, p = 0.773), with improvement in nearly half (48.5% PEG vs. 44.7% placebo). There was no correlation between KUB and urinary or bowel symptoms.
CONCLUSIONS


Nearly 50% of patients with urinary urge symptoms treated with either placebo or PEG for 1 month had improvement in urinary symptoms. KUB did not correlate with baseline or follow-up urinary or bowel symptoms.",2013,Patients treated with placebo and PEG both had significant improvement in USQ scores (p < 0.0001).,"['urinary urge symptoms', 'Patients aged >3 years underwent baseline urinary symptom questionnaire (USQ, scored 0-16), bowel symptom questionnaire (scored 0-20) and abdominal X-ray (KUB', 'overactive bladder (OAB) symptoms in children', 'Of 138 enrolled patients, 71 (51.4%) completed 1 month of therapy']","['placebo and PEG', 'placebo', 'placebo/PEG', 'Polyethylene glycol (PEG', 'placebo vs. PEG', 'placebo or PEG', 'polyethylene glycol (MiraLAX®', 'PEG']","['KUB', 'urinary symptoms', 'USQ (ΔUSQ', 'urinary and bowel symptoms to KUB', 'USQ scores', 'KUB and urinary or bowel symptoms']","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0034573', 'cui_str': 'Radiography, Abdominal'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0876088', 'cui_str': 'Miralax'}]","[{'cui': 'C0426359', 'cui_str': 'Urinary symptoms (finding)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",138.0,0.540826,Patients treated with placebo and PEG both had significant improvement in USQ scores (p < 0.0001).,"[{'ForeName': 'Nicol Corbin', 'Initials': 'NC', 'LastName': 'Bush', 'Affiliation': 'Department of Pediatric Urology, University of Texas Southwestern Medical Center, Dallas, TX 75207, USA. nicol.bush@childrens.com'}, {'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': ''}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Barber', 'Affiliation': ''}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Bernstein', 'Affiliation': ''}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Snodgrass', 'Affiliation': ''}]",Journal of pediatric urology,['10.1016/j.jpurol.2012.10.011']
979,31992300,Effects of protein intake prior to carbohydrate-restricted endurance exercise: a randomized crossover trial.,"BACKGROUND


Deliberately training with reduced carbohydrate availability, a paradigm coined training low, has shown to promote adaptations associated with improved aerobic capacity. In this context researchers have proposed that protein may be ingested prior to training as a means to enhance the protein balance during exercise without spoiling the effect of the low carbohydrate availability. Accordingly, this is being practiced by world class athletes. However, the effect of protein intake on muscle protein metabolism during training low has not been studied. This study aimed to examine if protein intake prior to exercise with reduced carbohydrate stores benefits muscle protein metabolism in exercising and non-exercising muscles.
METHODS


Nine well-trained subjects completed two trials in random order both of which included a high-intensity interval ergometer bike ride (day 1), a morning (day 2) steady state ride (90 min at 65% VO 2 peak, 90ss), and a 4-h recovery period. An experimental beverage was consumed before 90ss and contained either 0.5 g whey protein hydrolysate [WPH]/ kg lean body mass or flavored water [PLA]. A stable isotope infusion (L-[ring- 13 C 6 ]-phenylalanine) combined with arterial-venous blood sampling, and plasma flow rate measurements were used to determine forearm protein turnover. Myofibrillar protein synthesis was determined from stable isotope incorporation into the vastus lateralis.
RESULTS


Forearm protein net balance was not different from zero during 90ss exercise (nmol/100 ml/min, PLA: 0.5 ± 2.6; WPH: 1.8, ± 3.3) but negative during the 4 h recovery (nmol/100 ml/min, PLA: - 9.7 ± 4.6; WPH: - 8.7 ± 6.5); no interaction (P = 0.5) or main effect of beverage (P = 0.11) was observed. Vastus lateralis myofibrillar protein synthesis rates were increased during 90ss exercise (+ 0.02 ± 0.02%/h) and recovery (+ 0.02 ± 0.02%/h); no interaction (P = 0.3) or main effect of beverage (P = 0.3) was observed.
CONCLUSION


We conclude that protein ingestion prior to endurance exercise in the energy- and carbohydrate-restricted state does not increase myofibrillar protein synthesis or improve net protein balance in the exercising and non-exercising muscles, respectively, during and in the hours after exercise compared to ingestion of a non-caloric control.
TRIAL REGISTRATION


clinicaltrials.gov, NCT01320449. Registered 10 May 2017 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03147001.",2020,"Vastus lateralis myofibrillar protein synthesis rates were increased during 90ss exercise (+ 0.02 ± 0.02%/h) and recovery (+ 0.02 ± 0.02%/h); no interaction (P = 0.3) or main effect of beverage (P = 0.3) was observed.
",['Nine well-trained subjects completed two trials in random order both of which included a high-intensity interval ergometer bike ride (day 1'],"['protein intake prior to exercise with reduced carbohydrate stores', 'protein hydrolysate [WPH]/ kg lean body mass or flavored water [PLA', 'protein ingestion prior to endurance exercise', 'protein intake prior to carbohydrate-restricted endurance exercise', 'stable isotope infusion (L-[ring- 13 C 6 ]-phenylalanine']","['Forearm protein net balance', 'Vastus lateralis myofibrillar protein synthesis rates', 'net protein balance', 'muscle protein metabolism', 'Myofibrillar protein synthesis']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0033631', 'cui_str': 'Protein Hydrolysates'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope (substance)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C0729631', 'cui_str': 'C-13 isotope'}, {'cui': 'C0031453', 'cui_str': 'L-phenylalanine'}]","[{'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0026832', 'cui_str': 'Muscle Proteins'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",,0.0418323,"Vastus lateralis myofibrillar protein synthesis rates were increased during 90ss exercise (+ 0.02 ± 0.02%/h) and recovery (+ 0.02 ± 0.02%/h); no interaction (P = 0.3) or main effect of beverage (P = 0.3) was observed.
","[{'ForeName': 'Mads S', 'Initials': 'MS', 'LastName': 'Larsen', 'Affiliation': 'Department of Public Health, Aarhus University, Dalgas Ave. 4, 8000, Aarhus C, Denmark. msl@ph.au.dk.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Holm', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Mads V', 'Initials': 'MV', 'LastName': 'Svart', 'Affiliation': 'Medical Research Laboratory, Institute for Clinical Medicine, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Astrid J', 'Initials': 'AJ', 'LastName': 'Hjelholt', 'Affiliation': 'Medical Research Laboratory, Institute for Clinical Medicine, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Mads B', 'Initials': 'MB', 'LastName': 'Bengtsen', 'Affiliation': 'Medical Research Laboratory, Institute for Clinical Medicine, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Ole L', 'Initials': 'OL', 'LastName': 'Dollerup', 'Affiliation': 'Medical Research Laboratory, Institute for Clinical Medicine, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Line B', 'Initials': 'LB', 'LastName': 'Dalgaard', 'Affiliation': 'Department of Public Health, Aarhus University, Dalgas Ave. 4, 8000, Aarhus C, Denmark.'}, {'ForeName': 'Mikkel H', 'Initials': 'MH', 'LastName': 'Vendelbo', 'Affiliation': 'Department of Biomedicine, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Gerrit', 'Initials': 'G', 'LastName': 'van Hall', 'Affiliation': 'Clinical Metabolomics Core Facility, Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Medical Research Laboratory, Institute for Clinical Medicine, Aarhus University, Aarhus C, Denmark.'}, {'ForeName': 'Ulla R', 'Initials': 'UR', 'LastName': 'Mikkelsen', 'Affiliation': 'Arla Foods Ingredients Group P/S, Viby J, 8260, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Department of Public Health, Aarhus University, Dalgas Ave. 4, 8000, Aarhus C, Denmark.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-0338-z']
980,23942074,Baseline tumour measurements predict survival in advanced non-small cell lung cancer.,"BACKGROUND


The association between tumour measurements and survival has been studied extensively in early-stage and locally advanced non-small cell lung cancer (NSCLC). We analysed these factors in patients with advanced NSCLC.
METHODS


Data were derived from the E4599 trial of paclitaxel-carboplatin±bevacizumab. Associations between the Response Evaluation Criteria in Solid Tumors (RECIST) baseline sum longest diameter (BSLD), response rate, progression-free survival (PFS) and overall survival (OS) were evaluated using univariate and multivariable Cox regression models.
RESULTS


A total of 759 of the 850 patients (89%) in the E4599 trial had measurable diseases and were included in this analysis. The median BSLD was 7.5 cm. BSLD predicted OS (hazard ratio (HR) 1.41; P<0.001) and had a trend towards association with PFS (HR 1.14; P=0.08). The median OS was 12.6 months for patients with BSLD <7.5 cm compared with 9.5 months for BSLD ≥ 7.5 cm. This association persisted in a multivariable model controlling multiple prognostic factors, including the presence and sites of extrathoracic disease (HR 1.24; P=0.01). There was no association between BSLD and response rate.
CONCLUSION


Tumour measurements are associated with survival in the E4599 trial. If validated in other populations, this parameter may provide important prognostic information to patients and clinicians.",2013,BSLD predicted OS (hazard ratio (HR) 1.41; P<0.001) and had a trend towards association with PFS (HR 1.14; P=0.08).,"['A total of 759 of the 850 patients (89%) in the E4599 trial had measurable diseases and were included in this analysis', 'advanced non-small cell lung cancer', 'patients with advanced NSCLC', 'Solid Tumors', 'Data were derived from the E4599 trial of']",['paclitaxel-carboplatin±bevacizumab'],"['median OS', 'median BSLD', 'BSLD and response rate', 'RECIST) baseline sum longest diameter (BSLD), response rate, progression-free survival (PFS) and overall survival (OS', 'BSLD predicted OS']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3840657', 'cui_str': '850 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",850.0,0.361731,BSLD predicted OS (hazard ratio (HR) 1.41; P<0.001) and had a trend towards association with PFS (HR 1.14; P=0.08).,"[{'ForeName': 'D E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, Texas 75390 USA.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Dahlberg', 'Affiliation': ''}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Sandler', 'Affiliation': ''}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'J H', 'Initials': 'JH', 'LastName': 'Schiller', 'Affiliation': ''}, {'ForeName': 'J R', 'Initials': 'JR', 'LastName': 'Brahmer', 'Affiliation': ''}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Johnson', 'Affiliation': ''}]",British journal of cancer,['10.1038/bjc.2013.472']
981,23921906,"Comparative effectiveness of fecal immunochemical test outreach, colonoscopy outreach, and usual care for boosting colorectal cancer screening among the underserved: a randomized clinical trial.","IMPORTANCE


Colorectal cancer (CRC) screening saves lives, but participation rates are low among underserved populations. Knowledge on effective approaches for screening the underserved, including best test type to offer, is limited.
OBJECTIVE


To determine (1) if organized mailed outreach boosts CRC screening compared with usual care and (2) if FIT is superior to colonoscopy outreach for CRC screening participation in an underserved population.
DESIGN, SETTING, AND PARTICIPANTS


We identified uninsured patients, not up to date with CRC screening, age 54 to 64 years, served by the John Peter Smith Health Network, Fort Worth and Tarrant County, Texas, a safety net health system.
INTERVENTIONS


Patients were assigned randomly to 1 of 3 groups. One group was assigned to fecal immunochemical test (FIT) outreach, consisting of mailed invitation to use and return an enclosed no-cost FIT (n = 1593). A second was assigned to colonoscopy outreach, consisting of mailed invitation to schedule a no-cost colonoscopy (n = 479). The third group was assigned to usual care, consisting of opportunistic primary care visit–based screening (n = 3898). In addition, FIT and colonoscopy outreach groups received telephone follow-up to promote test completion.
MAIN OUTCOME MEASURES


Screening participation in any CRC test within 1 year after randomization.
RESULTS


Mean patient age was 59 years; 64% of patients were women. The sample was 41% white, 24% black, 29% Hispanic, and 7% other race/ethnicity. Screening participation was significantly higher for both FIT (40.7%) and colonoscopy outreach (24.6%) than for usual care (12.1%) (P < .001 for both comparisons with usual care). Screening was significantly higher for FIT than for colonoscopy outreach (P < .001). In stratified analyses, screening was higher for FIT and colonoscopy outreach than for usual care, and higher for FIT than for colonoscopy outreach among whites, blacks, and Hispanics (P < .005 for all comparisons). Rates of CRC identification and advanced adenoma detection were 0.4% and 0.8% for FIT outreach, 0.4% and 1.3% for colonoscopy outreach, and 0.2% and 0.4% for usual care, respectively (P < .05 for colonoscopy vs usual care advanced adenoma comparison; P > .05 for all other comparisons). Eleven of 60 patients with abnormal FIT results did not complete colonoscopy. CONCLUSIONS AND REVELANCE: Among underserved patients whose CRC screening was not up to date, mailed outreach invitations resulted in markedly higher CRC screening compared with usual care. Outreach was more effective with FIT than with colonoscopy invitation.
TRIAL REGISTRATION


clinicaltrials.gov Identifier: NCT01191411.",2013,Screening participation was significantly higher for both FIT (40.7%) and colonoscopy outreach (24.6%) than for usual care (12.1%) (P < .001 for both comparisons with usual care).,"['The sample was 41% white, 24% black, 29% Hispanic, and 7% other race/ethnicity', 'uninsured patients, not up to date with CRC screening, age 54 to 64 years, served by the John Peter Smith Health Network, Fort Worth and Tarrant County, Texas, a safety net health system', 'Mean patient age was 59 years; 64% of patients were women', '60 patients with abnormal FIT results did not complete colonoscopy', 'colorectal cancer screening among the underserved']","['fecal immunochemical test (FIT) outreach, consisting of mailed invitation to use and return an enclosed no-cost FIT', 'colonoscopy outreach, consisting of mailed invitation to schedule a no-cost colonoscopy', 'fecal immunochemical test outreach, colonoscopy outreach, and usual care', 'usual care, consisting of opportunistic primary care visit–based screening']","['Rates of CRC identification and advanced adenoma detection', 'colonoscopy outreach', 'Screening participation']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0087134', 'cui_str': 'Uninsured'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0554249', 'cui_str': 'Smith (occupation)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",,0.0388509,Screening participation was significantly higher for both FIT (40.7%) and colonoscopy outreach (24.6%) than for usual care (12.1%) (P < .001 for both comparisons with usual care).,"[{'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Halm', 'Affiliation': ''}, {'ForeName': 'Don C', 'Initials': 'DC', 'LastName': 'Rockey', 'Affiliation': ''}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Hammons', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Carter', 'Affiliation': ''}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Valdez', 'Affiliation': ''}, {'ForeName': 'Liyue', 'Initials': 'L', 'LastName': 'Tong', 'Affiliation': ''}, {'ForeName': 'Chul', 'Initials': 'C', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kashner', 'Affiliation': ''}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Argenbright', 'Affiliation': ''}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Tiro', 'Affiliation': ''}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Geng', 'Affiliation': ''}, {'ForeName': 'Sandi', 'Initials': 'S', 'LastName': 'Pruitt', 'Affiliation': ''}, {'ForeName': 'Celette Sugg', 'Initials': 'CS', 'LastName': 'Skinner', 'Affiliation': ''}]",JAMA internal medicine,[]
982,29976553,Beet the Best?,"RATIONALE


A primary goal of therapy for patients with peripheral artery disease (PAD) and intermittent claudication is increased ambulatory function. Supervised exercise rehabilitation was recently shown to confer superior walking benefits to pharmacological or surgical interventions. Increases in plasma inorganic nitrite, via oral nitrate, have been shown to increase exercise performance in both human and animal models, especially in hypoxic conditions.
OBJECTIVE


To determine whether a 36-session exercise rehabilitation program while consuming oral inorganic nitrate (4.2 mmol concentrated beetroot juice) would produce superior benefits over exercise plus placebo in pain-free walking and markers of increased skeletal muscle perfusion in patients with PAD and intermittent claudication.
METHODS AND RESULTS


This was a randomized, double-blind, per-protocol study design. After the 12-week protocol, claudication onset time on a maximal treadmill test increased by 59.2±57.3 s for the exercise plus placebo group (n=13) and by 180.3±46.6 s for the exercise plus beetroot juice group (n=11; P≤0.05). This produced a between treatment medium to large standardized effect size (Cohen d) of 0.62 (95% CI, -0.23 to +1.44). The data for 6-minute walk distance showed a similar pattern with increases of 24.6±12.1 and 53.3±19.6 m ( P≤0.05) in the exercise plus placebo and exercise plus beetroot juice groups, respectively. Measures of gastrocnemius perfusion, including ankle-brachial index, peak reactive hyperemic blood flow, and tissue deoxygenation characteristics, during exercise (assessed my near-infrared spectroscopy) all changed significantly for the exercise plus beetroot juice group with moderate-to-large effect sizes over exercise plus placebo changes.
CONCLUSIONS


Although it is premature to speculate on overall clinical utility of a nitrate-based therapy for PAD, this early pilot study evidence is encouraging. Specifically, our data suggests that increasing plasma nitrite before exercise may allow PAD subjects to train with less pain, at higher workloads for longer durations at each training session, thereby maximizing the beneficial peripheral vascular and skeletal muscle adaptations.
CLINICAL TRIAL REGISTRATION


URL: http://www.clinicaltrials.gov . Unique identifier: NCT01684930 and NCT01785524.",2018,"After the 12-week protocol, claudication onset time on a maximal treadmill test increased by 59.2±57.3 s for the exercise plus placebo group (n=13) and by 180.3±46.6 s for the exercise plus beetroot juice group (n=11; P≤0.05).","['patients with PAD and intermittent claudication', 'patients with peripheral artery disease (PAD) and intermittent claudication']","['exercise plus placebo', '36-session exercise rehabilitation program while consuming oral inorganic nitrate (4.2 mmol concentrated beetroot juice', 'Supervised exercise rehabilitation']","['gastrocnemius perfusion, including ankle-brachial index, peak reactive hyperemic blood flow, and tissue deoxygenation characteristics, during exercise (assessed my near-infrared spectroscopy', 'exercise performance', 'pain-free walking and markers of increased skeletal muscle perfusion', 'claudication onset time on a maximal treadmill test', '6-minute walk distance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0021775', 'cui_str': 'Intermittent Claudication'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1328319', 'cui_str': 'Ankle Brachial Index'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0376519', 'cui_str': 'Spectrometry, Near-Infrared'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1456822', 'cui_str': 'Claudication'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0087110', 'cui_str': 'Treadmill Test'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]",,0.409925,"After the 12-week protocol, claudication onset time on a maximal treadmill test increased by 59.2±57.3 s for the exercise plus placebo group (n=13) and by 180.3±46.6 s for the exercise plus beetroot juice group (n=11; P≤0.05).","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Woessner', 'Affiliation': 'From the Institute of Health and Sport, Victoria University, Melbourne, Australia (M.W.).'}, {'ForeName': 'Mitch D', 'Initials': 'MD', 'LastName': 'VanBruggen', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University Medical Center, Durham, NC (M.W., M.D.V., W.E.K., J.D.A.).'}, {'ForeName': 'Carl F', 'Initials': 'CF', 'LastName': 'Pieper', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC (C.F.P., R.S.).'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Sloane', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC (C.F.P., R.S.).'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University Medical Center, Durham, NC (M.W., M.D.V., W.E.K., J.D.A.).'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Gow', 'Affiliation': 'Department of Pharmacology and Toxicology, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ (A.J.G.).'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Allen', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University Medical Center, Durham, NC (M.W., M.D.V., W.E.K., J.D.A.).'}]",Circulation research,['10.1161/CIRCRESAHA.118.313131']
983,23290327,"A 12-week, randomized, double-blind, placebo-controlled, sequential parallel comparison trial of ziprasidone as monotherapy for major depressive disorder.","OBJECTIVE


To study ziprasidone monotherapy for major depressive disorder, defined according to the DSM-IV.
METHOD


One hundred twenty outpatients were enrolled between June 2008 and September 2010 in a 12-week study that was divided into two 6-week periods according to the sequential parallel comparison design. Patients were randomized in a 2:3:3 fashion to receive ziprasidone for 12 weeks, placebo for 6 weeks followed by ziprasidone for 6 weeks, or placebo for 12 weeks. The main outcome measure was the 17-item Hamilton Depression Rating Scale (HDRS-17), with the Quick Inventory of Depressive Symptomatology, Self-Rated (QIDS-SR), and Clinical Global Impressions-Severity of Illness scale (CGI-S) serving as the study secondary measures.
RESULTS


One hundred twenty patients (53 women [44.1%]) were randomized to treatment. The mean (SD) age of these patients was 43.7 (11.0) years. Mean (SD) baseline HDRS-17, CGI-S, and QIDS-SR scores were 19.9 (5.0), 4.3 (0.6), and 15.6 (3.0), respectively. There was no statistically significant difference in reduction of depressive symptoms, response rates, or remission rates between ziprasidone- or placebo-treated patients. This was true for both the study primary as well as secondary outcome scales.
CONCLUSIONS


In conclusion, treatment with ziprasidone monotherapy was not associated with any statistically significant advantage in efficacy over placebo. Although studies involving larger sample size would be required to have adequate statistical power to detect treatment differences smaller than 2.5 points on the HDRS-17, such differences would be of questionable clinical relevance.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00555997.",2012,"There was no statistically significant difference in reduction of depressive symptoms, response rates, or remission rates between ziprasidone- or placebo-treated patients.","['One hundred twenty outpatients were enrolled between June 2008 and September 2010 in a 12-week study', 'major depressive disorder', 'One hundred twenty patients (53 women [44.1']","['ziprasidone', 'ziprasidone monotherapy', 'placebo']","['Mean (SD) baseline HDRS-17, CGI-S, and QIDS-SR scores', 'reduction of depressive symptoms, response rates, or remission rates', '17-item Hamilton Depression Rating Scale (HDRS-17), with the Quick Inventory of Depressive Symptomatology, Self-Rated (QIDS-SR), and Clinical Global Impressions-Severity of Illness scale (CGI-S) serving as the study secondary measures']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0380393', 'cui_str': 'ziprasidone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",120.0,0.168344,"There was no statistically significant difference in reduction of depressive symptoms, response rates, or remission rates between ziprasidone- or placebo-treated patients.","[{'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Center for Treatment-Resistant Depression, Depression Clinical and Research Program, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA. gpapakostas@partners.org'}, {'ForeName': 'Ottavio V', 'Initials': 'OV', 'LastName': 'Vitolo', 'Affiliation': ''}, {'ForeName': 'Waguih W', 'Initials': 'WW', 'LastName': 'Ishak', 'Affiliation': ''}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Rapaport', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Zajecka', 'Affiliation': ''}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Kinrys', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mischoulon', 'Affiliation': ''}, {'ForeName': 'Samuel H', 'Initials': 'SH', 'LastName': 'Lipkin', 'Affiliation': ''}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Hails', 'Affiliation': ''}, {'ForeName': 'Jonah', 'Initials': 'J', 'LastName': 'Abrams', 'Affiliation': ''}, {'ForeName': 'Sean G', 'Initials': 'SG', 'LastName': 'Ward', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Meisner', 'Affiliation': ''}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schoenfeld', 'Affiliation': ''}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Winokur', 'Affiliation': ''}, {'ForeName': 'Mahmoud S', 'Initials': 'MS', 'LastName': 'Okasha', 'Affiliation': ''}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Bari', 'Affiliation': ''}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': ''}]",The Journal of clinical psychiatry,['10.4088/JCP.12m07670']
984,25007003,"Efficacy and safety of quetiapine-XR as monotherapy or adjunctive therapy to a mood stabilizer in acute bipolar depression with generalized anxiety disorder and other comorbidities: a randomized, placebo-controlled trial.","OBJECTIVE


To study the efficacy and safety of quetiapine-XR as monotherapy or adjunctive therapy to a mood stabilizer in acute bipolar I or II depression with comorbid generalized anxiety disorder (GAD) and other comorbidities.
METHOD


The study was conducted from January 2007 to November 2011. The Mini-International Neuropsychiatric Interview was used to ascertain the diagnosis of DSM-IV bipolar disorder, GAD, and other Axis I disorders. Eligible patients were randomly assigned to quetiapine-XR or placebo for up to 8 weeks. The Hamilton Depression Rating Scale-17 items (HDRS-17) was used as a primary outcome to evaluate the difference between the 2 groups using the change from baseline to end of study. Last observation carried forward and mixed-effects modeling for repeated measures were used to analyze the primary and secondary outcome measures.
RESULTS


Of the 120 patients screened, 100 patients were randomized to receive quetiapine-XR (n = 50) or placebo (n = 50). Twenty-six patients in the quetiapine-XR and 18 in the placebo group completed the study. The mean quetiapine-XR dose was 276 ± 50 mg/d (50-300 mg/d). There was no significant difference between the 2 groups in the change from baseline to end of study in HDRS-17 total score with an effect size of 0.19 favoring quetiapine-XR. There were also no significant differences between the 2 groups in secondary efficacy and safety outcome measures.
CONCLUSIONS


Quetiapine-XR was not significantly superior to placebo in bipolar I or II depression with GAD and other comorbidities, suggesting that data from relatively ""pure"" bipolar patients may not be generalizable to a highly comorbid population.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT00671853.",2014,There was no significant difference between the 2 groups in the change from baseline to end of study in HDRS-17 total score with an effect size of 0.19 favoring quetiapine-XR.,"['100 patients', 'Twenty-six patients in the', 'Eligible patients', '120 patients screened', 'January 2007 to November 2011', 'acute bipolar depression with generalized anxiety disorder and other comorbidities', 'acute bipolar I or II depression with comorbid generalized anxiety disorder (GAD) and other comorbidities']","['Quetiapine-XR', 'quetiapine-XR', 'placebo', 'quetiapine-XR or placebo']","['Efficacy and safety', 'HDRS-17 total score', 'secondary efficacy and safety outcome measures', 'Hamilton Depression Rating Scale-17 items (HDRS-17']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]",100.0,0.0826703,There was no significant difference between the 2 groups in the change from baseline to end of study in HDRS-17 total score with an effect size of 0.19 favoring quetiapine-XR.,"[{'ForeName': 'Keming', 'Initials': 'K', 'LastName': 'Gao', 'Affiliation': 'Department of Psychiatry, University Hospitals Case Medical Center/Case Western Reserve University School of Medicine, 10524 Euclid Ave, 12th floor, Cleveland, OH 44106 keming.gao@uhhospitals.org.'}, {'ForeName': 'Renrong', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kemp', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Karberg', 'Affiliation': ''}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Conroy', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Ren', 'Affiliation': ''}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Serrano', 'Affiliation': ''}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Ganocy', 'Affiliation': ''}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': ''}]",The Journal of clinical psychiatry,['10.4088/JCP.13m08847']
985,31361675,"""I Am Sure That They Use My PROM Data for Something Important."" A Qualitative Study About Patients' Experiences From a Hematologic Outpatient Clinic.","BACKGROUND


Patient-reported outcome measures (PROMs) in clinical practice have the potential to contribute to and support shared decision-making processes by giving voice to patient concerns during consultations. However, the perspectives of patients diagnosed with chronic hematologic cancer on the use of PROMs are unknown.
OBJECTIVE


To describe how patients diagnosed with hematologic cancer experience participating in a randomized PROM intervention study, including initial invitation, completion of questionnaires, and outpatient clinic visits.
METHODS


A qualitative conceptual framework guided the study, using Interpretive Description with a focused ethnographic approach to explore patient experiences with PROMs in applied practice. Analysis was inspired by Habermas' social theory of communicative action.
RESULTS


The analysis revealed 3 predominant themes of patient experiences: that PROMs were ""In the service of a good cause,"" ""The questions are not really spot on,"" and ""PROMs are sometimes used for something,"" that is, unknown to the patient.
CONCLUSIONS


The patients' experiences were dominated by the perspective of the healthcare system and by gratitude and imbalanced power relations. During completion of questionnaires, patients struggled to identify with items, and the questionnaires were associated with low content validity. When visiting the outpatient clinic, patients reported that doctors and nurses rarely discussed patients' PROMs.
IMPLICATIONS FOR PRACTICE


This study contributes knowledge of patient experiences of the integration of PROMs in hematologic outpatient clinical practice. Findings can guide further research and improve future implementation of PROMs.",2020,"The analysis revealed 3 predominant themes of patient experiences: that PROMs were ""In the service of a good cause,"" ""The questions are not really spot on,"" and ""PROMs are sometimes used for something,"" that is, unknown to the patient.
","['patients diagnosed with hematologic cancer experience participating in a randomized PROM intervention study, including initial invitation, completion of questionnaires, and outpatient clinic visits', 'patients diagnosed with chronic hematologic cancer', ""Patients' Experiences From a Hematologic Outpatient Clinic""]",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}]",[],[],,0.0177208,"The analysis revealed 3 predominant themes of patient experiences: that PROMs were ""In the service of a good cause,"" ""The questions are not really spot on,"" and ""PROMs are sometimes used for something,"" that is, unknown to the patient.
","[{'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Thestrup Hansen', 'Affiliation': 'Author Affiliations: Department of Hematology, Zealand University Hospital, Roskilde (Ms Thestrup Hansen, Kjerholt, and Dr Friis Christensen); Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense (Ms Thestrup Hansen and Dr Hølge-Hazelton); Faculty of Health and Medical Sciences, University of Copenhagen, Denmark (Ms Friis Christensen) and Department of General Practice, Institute of Public Health, Faculty of Health Sciences Copenhagen, (Dr Brodersen); and Research Support Unit, Zealand University Hospital, Roskilde (Dr Hølge-Hazelton), Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Kjerholt', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Friis Christensen', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brodersen', 'Affiliation': ''}, {'ForeName': 'Bibi', 'Initials': 'B', 'LastName': 'Hølge-Hazelton', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000738']
986,31916036,Anti-inflammatory potential of an essential oil-containing mouthwash in elderly subjects enrolled in supportive periodontal therapy: a 6-week randomised controlled clinical trial.,"OBJECTIVES


Essential oils and other plant extracts have evoked interest as sources of natural medicinal products. They have been proven to exert antibacterial, antifungal, antiviral and antioxidant properties, but the mechanism of action has not been fully elucidated.
AIM


This study aims to evaluate the potential of a sage-containing mouthwash to alleviate inflammatory signs of intra-oral mucosa and gingiva in comparison with a water/alcohol-based placebo.
MATERIAL AND METHODS


This study was conducted as a randomised, placebo-controlled, double-blind, parallel design clinical study. Forty-eight dentate subjects were randomly assigned to a test (sage-containing mouthwash) or a placebo group (water/alcohol-based solution). Subjects rinsed once daily for 30 s over a period of 6 weeks. Sulcus Bleeding Index (SBI), Plaque Index (PLI), tooth staining, xerostomia and degree of stomatitis were assessed at baseline and after 6 weeks.
RESULTS


Subjects' mean age was 77.5 ± 7.3 years. SBI was reduced from 1.3 ± 0.9 to 0.8 ± 0.7 (test, p = 0.0029) and 1.4 ± 0.9 to 1.1 ± 0.7 (placebo, p = 0.0105). Similarly, PLI was reduced from 1.2 ± 0.5 to 1.0 ± 0.3 (test, p = 0.0080) and 1.3 ± 0.4 to 1.1 ± 0.6 (placebo, p = 0.0087); no between-group differences were found (p > 0.05). Stomatitis, xerostomia and tooth staining revealed no change after 6 weeks.
CONCLUSION


The irrigation with a sage-containing mouthwash did not result in a superior beneficial effect on inflammatory parameters and plaque indices compared with the placebo. The expected contribution of the plant extracts to their potential impact on oral health may need further investigation.
CLINICAL RELEVANCE


The proposed mouthwash might be suitable for patients with inflammatory signs of the gingiva who prefer natural remedies.",2020,The irrigation with a sage-containing mouthwash did not result in a superior beneficial effect on inflammatory parameters and plaque indices compared with the placebo.,"['elderly subjects enrolled in supportive periodontal therapy', 'Forty-eight dentate subjects', ""Subjects' mean age was 77.5\u2009±\u20097.3\xa0years"", 'patients with inflammatory signs of the gingiva who prefer natural remedies']","['sage-containing mouthwash', 'placebo', 'essential oil-containing mouthwash', 'water/alcohol-based placebo', 'placebo group (water/alcohol-based solution']","['SBI', 'PLI', 'Sulcus Bleeding Index (SBI), Plaque Index (PLI), tooth staining, xerostomia and degree of stomatitis', 'inflammatory parameters and plaque indices', 'Stomatitis, xerostomia and tooth staining']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0017562', 'cui_str': 'Gums'}, {'cui': 'C3543840', 'cui_str': 'Preferred'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}]","[{'cui': 'C1122976', 'cui_str': 'Sage (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0028910', 'cui_str': 'Oils, Essential'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.386102,The irrigation with a sage-containing mouthwash did not result in a superior beneficial effect on inflammatory parameters and plaque indices compared with the placebo.,"[{'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Jünger', 'Affiliation': 'Division of Gerodontology, Department of Reconstructive Dentistry and Gerodontology, School of Dental Medicine, University of Bern, Freiburgstrasse 7, 3010, Bern, Switzerland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jaun-Ventrice', 'Affiliation': 'Division of Gerodontology, Department of Reconstructive Dentistry and Gerodontology, School of Dental Medicine, University of Bern, Freiburgstrasse 7, 3010, Bern, Switzerland.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Guldener', 'Affiliation': 'Department of Periodontology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christoph A', 'Initials': 'CA', 'LastName': 'Ramseier', 'Affiliation': 'Department of Periodontology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Reissmann', 'Affiliation': 'Department of Prosthetic Dentistry, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schimmel', 'Affiliation': 'Division of Gerodontology, Department of Reconstructive Dentistry and Gerodontology, School of Dental Medicine, University of Bern, Freiburgstrasse 7, 3010, Bern, Switzerland. martin.schimmel@zmk.unibe.ch.'}]",Clinical oral investigations,['10.1007/s00784-019-03194-3']
987,31697042,Safety and efficacy of the Tablo hemodialysis system for in-center and home hemodialysis.,"INTRODUCTION


Home hemodialysis remains underutilized despite observational data indicating more favorable outcomes with home compared with in-center hemodialysis. The Tablo Hemodialysis system is designed to be easy to learn and use and to facilitate adoption of home hemodialysis. The objective of the current investigational device exemption (IDE) study was to evaluate the safety and efficacy of Tablo managed in-center by health care professionals and in-home by patients and/or caregivers.
METHODS


A prospective, multicenter, open-label, crossover trial comparing in-center and in-home hemodialysis using Tablo. There were 4 treatment periods during which hemodialysis was prescribed 4 times per week: 1-week Run-In, 8-week In-Center, 4-week Transition, and 8-week In-Home. The primary efficacy endpoint was weekly standard Kt/V urea   ≥ 2.1. The secondary efficacy endpoint was delivery of ultrafiltration (UF) within 10% of prescribed UF. We collected safety and usability data.
FINDINGS


Thirty participants enrolled and 28 completed all trial periods. Adherence to the protocol requirement of 4 treatments per week was 96% in-center and 99% in-home. The average prescribed and delivered session lengths were 3.4 hours for both the In-Center and the In-Home periods. The primary efficacy endpoint for the intention-to-treat cohort was achieved in 199/200 (99.5%) of measurements during the In-Center period and 168/171 (98.3%) In-Home. The average weekly standard Kt/V urea  was 2.8 in both periods. The secondary efficacy UF endpoint was achieved in the ITT cohort in 94% in both in-center and in-home. Two prespecified adverse events (AEs) occurred during the In-Center period and 6 in the In-Home period. None of the AEs were deemed by investigators as related to Tablo. The median resolution time of alarms was 8 seconds in-center and 5 seconds in-home.
CONCLUSION


Primary and secondary efficacy and safety endpoints were achieved during both In-Center and In-Home trial periods. This study confirms that Tablo is safe and effective for home hemodialysis use.",2020,The average prescribed and delivered session lengths were 3.4 hours for both the In-Center and the In-Home periods.,"['Thirty participants enrolled and 28 completed all trial periods', 'patients and/or caregivers']",['Tablo hemodialysis system'],"['weekly standard Kt/V urea  \u2009≥\u20092.1', 'intention-to-treat cohort', 'delivery of ultrafiltration (UF', 'median resolution time of alarms', 'Safety and efficacy', 'adverse events (AEs', 'secondary efficacy UF endpoint', 'safety and efficacy']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0429662', 'cui_str': 'kt/V (observable entity)'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0336648', 'cui_str': 'Alarm, device (physical object)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",30.0,0.0341899,The average prescribed and delivered session lengths were 3.4 hours for both the In-Center and the In-Home periods.,"[{'ForeName': 'Troy J', 'Initials': 'TJ', 'LastName': 'Plumb', 'Affiliation': 'University of Nebraska, Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Alvarez', 'Affiliation': 'Palo Alto Medical Foundation, Palo Alto, California, USA.'}, {'ForeName': 'Dennis L', 'Initials': 'DL', 'LastName': 'Ross', 'Affiliation': 'Kansas Nephrology Research Institute, Wichita, Kansas, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Nephrology Associates Medical Group, Riverside, California, USA.'}, {'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'Mulhern', 'Affiliation': 'Fresenius Kidney Care Pioneer Valley Dialysis, West Springfield, Massachusetts, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Bell', 'Affiliation': 'Southwest Georgia Nephrology Clinic, Albany, Georgia, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Abra', 'Affiliation': 'Satellite Healthcare, Mountain View, California, USA.'}, {'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Prichard', 'Affiliation': 'University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Glenn M', 'Initials': 'GM', 'LastName': 'Chertow', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, California, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Aragon', 'Affiliation': 'Clinical Development, Outset Medical, San Jose, California, USA.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12795']
988,21601287,Randomized comparison of selective serotonin reuptake inhibitor (escitalopram) monotherapy and antidepressant combination pharmacotherapy for major depressive disorder with melancholic features: a CO-MED report.,"BACKGROUND


The clinical effects of antidepressant combinations vs. monotherapy as initial treatment for major depression with melancholic features (MDD-MF) are unknown.
METHODS


Outpatients with chronic or recurrent major depression (MDD) were randomized to initial treatment with escitalopram+placebo (the MONO condition), bupropion-sustained release+escitalopram, or venlafaxine-extended release+mirtazapine (the COMB conditions) in the Combining Medications to Enhance Depression Outcomes (CO-MED) trial. Secondary data analyses were conducted to compare demographic and clinical characteristics, and contrast clinical responses according to drug treatment, in patients with MDD-MF (n=124) and non-melancholic MDD (n=481).
RESULTS


While numerically lower, remission rates in MDD-MF did not differ significantly from those with non-melancholic MDD either at 12 (33.1% vs. 41.0%, aOR 1.16, p=0.58) or 28 (39.5% vs. 46.8%, aOR=1.02, p=0.93) weeks of treatment. Remission rates did not differ significantly between combination and monotherapy groups in either MDD-MF or non-melancholic MDD patients at either time point. Similar conclusions were reached for response rates, premature study discontinuation, and self-rated depression symptom severity.
LIMITATIONS


This is a secondary analysis of data from the CO-MED trial, which was not designed to address differential treatment response in melancholic and non-melancholic MDD.
CONCLUSIONS


We found no evidence of differential remission or response rates to antidepressant combination or monotherapy between melancholic/non-melancholic MDD patients, or according to antidepressant treatment group, after 12 and 28 weeks. Melancholic features may not be a valid predictor of more favorable response to antidepressant combination therapy as initial treatment.",2011,Remission rates did not differ significantly between combination and monotherapy groups in either MDD-MF or non-melancholic MDD patients at either time point.,"['Outpatients with chronic or recurrent major depression (MDD', 'patients with MDD-MF (n=124) and non-melancholic MDD (n=481', 'major depressive disorder with melancholic features', 'major depression with melancholic features (MDD-MF']","['escitalopram+placebo (the MONO condition), bupropion-sustained release+escitalopram, or venlafaxine-extended release+mirtazapine (the COMB conditions', 'antidepressant combination or monotherapy', 'antidepressant combinations vs. monotherapy', 'selective serotonin reuptake inhibitor (escitalopram) monotherapy and antidepressant combination pharmacotherapy']","['differential remission or response rates', 'Remission rates', 'remission rates in MDD-MF', 'response rates, premature study discontinuation, and self-rated depression symptom severity']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0154409', 'cui_str': 'Recurrent major depressive episodes (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096724', 'cui_str': 'Major depressive disorder with melancholic features'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0540173', 'cui_str': 'MonoS'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C3854046', 'cui_str': 'Comb'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C4552594', 'cui_str': 'SSRI - Selective serotonin reuptake inhibitor'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}]",,0.0287307,Remission rates did not differ significantly between combination and monotherapy groups in either MDD-MF or non-melancholic MDD patients at either time point.,"[{'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Bobo', 'Affiliation': 'Department of Psychiatry, Vanderbilt University School of Medicine, Nashville, TN, USA. william.v.bobo@vanderbilt.edu'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': ''}, {'ForeName': 'Jonathan W', 'Initials': 'JW', 'LastName': 'Stewart', 'Affiliation': ''}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': ''}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': ''}, {'ForeName': 'Benji T', 'Initials': 'BT', 'LastName': 'Kurian', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Warden', 'Affiliation': ''}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Morris', 'Affiliation': ''}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Luther', 'Affiliation': ''}, {'ForeName': 'Mustafa M', 'Initials': 'MM', 'LastName': 'Husain', 'Affiliation': ''}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Cook', 'Affiliation': ''}, {'ForeName': 'Ira M', 'Initials': 'IM', 'LastName': 'Lesser', 'Affiliation': ''}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Kornstein', 'Affiliation': ''}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Wisniewski', 'Affiliation': ''}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Rush', 'Affiliation': ''}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': ''}]",Journal of affective disorders,['10.1016/j.jad.2011.04.032']
989,31629915,Nivolumab Monotherapy and Nivolumab Plus Ipilimumab in Recurrent Small Cell Lung Cancer: Results From the CheckMate 032 Randomized Cohort.,"INTRODUCTION


Nivolumab monotherapy is approved in the United States for third-line or later metastatic small cell lung cancer based on pooled data from nonrandomized and randomized cohorts of the multicenter, open-label, phase 1/2 trial of nivolumab ± ipilimumab (CheckMate 032; NCT01928394). We report updated results, including long-term overall survival (OS), from the randomized cohort.
METHODS


Patients with small cell lung cancer and disease progression after one to two prior chemotherapy regimens were randomized 3:2 to nivolumab 3 mg/kg every 2 weeks or nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for four cycles followed by nivolumab 3 mg/kg every 2 weeks. Patients were stratified by number of prior chemotherapy regimens and treated until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) by blinded independent central review.
RESULTS


Overall, 147 patients received nivolumab and 96 nivolumab plus ipilimumab. Minimum follow-up for ORR/progression-free survival/safety was 11.9 months (nivolumab) and 11.2 months (nivolumab plus ipilimumab). ORR increased with nivolumab plus ipilimumab (21.9% versus 11.6% with nivolumab; odds ratio: 2.12; 95% confidence interval: 1.06-4.26; p = 0.03). For long-term OS, minimum follow-up was 29.0 months (nivolumab) versus 28.4 months (nivolumab plus ipilimumab); median (95% confidence interval) OS was 5.7 (3.8-7.6) versus 4.7 months (3.1-8.3). Twenty-four-month OS rates were 17.9% (nivolumab) and 16.9% (nivolumab plus ipilimumab). Grade 3 to 4 treatment-related adverse event rates were 12.9% (nivolumab) versus 37.5% (nivolumab plus ipilimumab), and treatment-related deaths were n =1 versus n = 3, respectively.
CONCLUSIONS


Whereas ORR (primary endpoint) was higher with nivolumab plus ipilimumab versus nivolumab, OS was similar between groups. In each group, OS remained encouraging with long-term follow-up. Toxicities were more common with combination therapy versus nivolumab monotherapy.",2020,ORR increased with nivolumab plus ipilimumab (21.9% versus 11.6% with nivolumab; odds ratio: 2.12 [95% CI: 1.06-4.26]; p=0.03).,"['147 patients received', 'Patients with SCLC and disease progression after 1-2 prior chemotherapy regimens', 'Recurrent Small Cell Lung Cancer']","['Nivolumab monotherapy', 'nivolumab and 96 nivolumab plus ipilimumab', 'nivolumab 3 mg/kg Q2W or nivolumab 1 mg/kg plus ipilimumab 3 mg/kg Q3W', 'nivolumab plus ipilimumab', 'Nivolumab Monotherapy and Nivolumab Plus Ipilimumab']","['ORR', 'OS', 'Toxicities', 'objective response rate (ORR', 'adverse event rates', '24-month OS rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",147.0,0.313681,ORR increased with nivolumab plus ipilimumab (21.9% versus 11.6% with nivolumab; odds ratio: 2.12 [95% CI: 1.06-4.26]; p=0.03).,"[{'ForeName': 'Neal E', 'Initials': 'NE', 'LastName': 'Ready', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina. Electronic address: neal.ready@duke.edu.'}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Ott', 'Affiliation': 'Dana Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Hellmann', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, New York; Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Zugazagoitia', 'Affiliation': 'University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Hann', 'Affiliation': 'Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Braud', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan; University of Milan, Milan, Italy.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'H. Lee Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"", Naples, Italy.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Moreno', 'Affiliation': 'START Madrid - FJD, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Akin', 'Initials': 'A', 'LastName': 'Atmaca', 'Affiliation': 'Department of Oncology and Hematology, Krankenhaus Nordwest, UCT-University Cancer Center, Frankfurt, Germany.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Salvagni', 'Affiliation': 'Policlinico S.Orsola-Malpighi, Azienda Ospedaliero Universitaria, Bologna, Italy.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Taylor', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Asim', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Levine Cancer Institute, Atrium Healthcare System, Charlotte, North Carolina.'}, {'ForeName': 'D Ross', 'Initials': 'DR', 'LastName': 'Camidge', 'Affiliation': 'University of Colorado Denver, Aurora, Colorado.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Vanderbilt Ingram Cancer Center, Nashville, Tennessee.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Calvo', 'Affiliation': 'START Madrid - CIOCC, Centro Integral Oncológico Clara Campal, Madrid, Spain.'}, {'ForeName': 'Ang', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, New Jersey.'}, {'ForeName': 'Wen Hong', 'Initials': 'WH', 'LastName': 'Lin', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, New Jersey.'}, {'ForeName': 'Margaret K', 'Initials': 'MK', 'LastName': 'Callahan', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, New York.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Spigel', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology Nashville, Nashville, Tennessee.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.10.004']
990,32493179,Effects of Preferred and Nonpreferred Warm-Up Music on Exercise Performance.,"This study investigated the effects of preferred and non-preferred warm-up music listening conditions on subsequent exercise performance. A total of 12 physically active male and female participants engaged in a crossover, counterbalanced research design in which they completed exercise trials after 3 different warm-up experiences of (a) no music (NM), (b) preferred music (PREF), and (c) nonpreferred music (NON-PREF). Participants began warming up by rowing at 50% of of age-predicted heart rate maximum (HR max ) for 5 minutes while exposed to the three music conditions. Immediately following the warm-up and cessation of any music, participants completed a 2000-m rowing time trial as fast as possible. Relative power output, trial time, heart rate, rating of perceived exertion, and motivation were analyzed. Results indicated that, compared with NM, relative power output was significantly higher ( p   =    .018), trial time was significantly lower ( p   =    .044), and heart rate was significantly higher ( p   =    .032) during the PREF but not the NON-PREF condition. Rating of perceived exertion was not altered, regardless of music condition ( p  > .05). Motivation to exercise was higher during the PREF condition versus the NM ( p   =    .001) and NON-PREF ( p  <   .001) conditions. Listening to preferred warm-up music improved subsequent exercise performance compared with no music, while nonpreferred music did not impart ergogenic benefit.",2020,Motivation to exercise was higher during the PREF condition versus the NM ( p   =    .001) and NON-PREF ( p  <   .001) conditions.,['12 physically active male and female participants'],"['Preferred and Nonpreferred Warm-Up Music', 'no music (NM), (b) preferred music (PREF), and (c) nonpreferred music (NON-PREF', 'preferred and non-preferred warm-up music listening conditions']","['Exercise Performance', 'heart rate maximum (HR max ', 'trial time', 'Motivation to exercise', 'subsequent exercise performance', 'relative power output', 'heart rate', 'Rating of perceived exertion', 'Relative power output, trial time, heart rate, rating of perceived exertion, and motivation']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",12.0,0.167338,Motivation to exercise was higher during the PREF condition versus the NM ( p   =    .001) and NON-PREF ( p  <   .001) conditions.,"[{'ForeName': 'Morgan C', 'Initials': 'MC', 'LastName': 'Karow', 'Affiliation': 'Department of Kinesiology, Samford University, Birmingham, Alabama, United States.'}, {'ForeName': 'Rebecca R', 'Initials': 'RR', 'LastName': 'Rogers', 'Affiliation': 'Department of Kinesiology, Samford University, Birmingham, Alabama, United States.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Pederson', 'Affiliation': 'Department of Kinesiology, Samford University, Birmingham, Alabama, United States.'}, {'ForeName': 'Tyler D', 'Initials': 'TD', 'LastName': 'Williams', 'Affiliation': 'Department of Kinesiology, Samford University, Birmingham, Alabama, United States.'}, {'ForeName': 'Mallory R', 'Initials': 'MR', 'LastName': 'Marshall', 'Affiliation': 'Department of Kinesiology, Samford University, Birmingham, Alabama, United States.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Ballmann', 'Affiliation': 'Department of Kinesiology, Samford University, Birmingham, Alabama, United States.'}]",Perceptual and motor skills,['10.1177/0031512520928244']
991,22386831,"The APC and PreSAP trials: a post hoc noninferiority analysis using a comprehensive new measure for gastrointestinal tract injury in 2 randomized, double-blind studies comparing celecoxib and placebo.","BACKGROUND


Previous gastrointestinal (GI) outcomes of nonsteroidal anti-inflammatory drug (NSAID) trials have focused on upper GI events, although recent evidence suggests NSAID-related lower GI effects are important and clinically relevant.
OBJECTIVE


We assessed the long-term GI adverse event (AE) profile of celecoxib in a nonarthritis population. The aim of this post hoc analysis was to determine the incidence of serious GI AEs, using a new Clinically Significant Upper and/or Lower GI Events end point.
METHODS


Patients from 2 colorectal adenoma recurrence studies were included. Patients received celecoxib 200 mg/400 mg BID, 400 mg once daily, or placebo over 3 years. The analysis measured noninferiority, using a prespecified definition of noninferiority. Celecoxib was predefined to be noninferior to placebo if the upper limit of the 95% CI for the hazard ratio (HR) with celecoxib was <1.25, at any dose, compared with the placebo (calculated using the Cox proportional hazards model).
RESULTS


A total of 3588 patients were included; in the primary analysis, the HR for celecoxib (any dose) compared with placebo was 1.22 (95% CI: 0.69-2.18; P = 0.4948). In the secondary dose analyses, the HR associated with a 400-mg daily dose, compared with placebo, was 1.04 (95% CI: 0.55-1.96; P = 0.9149); for 800 mg/d, the HR was 1.79 (95% CI: 0.82-3.89; P = 0.1427). In a third covariate analysis, low-dose aspirin use (HR = 2.33; 95% CI: 1.33-4.08) and age ≥65 years (HR = 1.82; 95% CI, 1.05-3.15) was suggested to have a statistically significant association with increased risk of GI AEs. Study limitations include retrospective evaluation and small sample size of patients with GI AEs.
CONCLUSIONS


The noninferiority of celecoxib to placebo was not established because the HR for the time to the first Clinically Significant Upper and/or Lower GI Event was greater than the prespecified upper limit of 95% CI for noninferiority. In addition, HRs associated with daily doses of 400 or 800 mg celecoxib compared with placebo were not significant. However, a significantly increased risk of clinically significant upper and/or lower GI events was observed in low-dose aspirin users (≤162.5 mg average daily use) and in patients ≥65 years of age.",2012,"In a third covariate analysis, low-dose aspirin use (HR = 2.33; 95% CI: 1.33-4.08) and age ≥65 years (HR = 1.82; 95% CI, 1.05-3.15) was suggested to have a statistically significant association with increased risk of GI AEs.","['3588 patients', 'Patients from 2 colorectal adenoma recurrence studies were included', 'patients with GI AEs']","['Celecoxib', 'placebo', 'aspirin', 'nonsteroidal anti-inflammatory drug (NSAID', 'celecoxib and placebo', 'celecoxib']","['risk of GI AEs', 'risk of clinically significant upper and/or lower GI events', 'long-term GI adverse event (AE) profile']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",3588.0,0.763527,"In a third covariate analysis, low-dose aspirin use (HR = 2.33; 95% CI: 1.33-4.08) and age ≥65 years (HR = 1.82; 95% CI, 1.05-3.15) was suggested to have a statistically significant association with increased risk of GI AEs.","[{'ForeName': 'Nadir', 'Initials': 'N', 'LastName': 'Arber', 'Affiliation': 'The Integrated Cancer Prevention Center, Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. nadir@tasmc.health.gov.il'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lieberman', 'Affiliation': ''}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'George H', 'Initials': 'GH', 'LastName': 'Sands', 'Affiliation': ''}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Bertagnolli', 'Affiliation': ''}, {'ForeName': 'Ernest T', 'Initials': 'ET', 'LastName': 'Hawk', 'Affiliation': ''}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Eagle', 'Affiliation': ''}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Coindreau', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Zauber', 'Affiliation': ''}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Lanas', 'Affiliation': ''}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Levin', 'Affiliation': ''}]",Clinical therapeutics,['10.1016/j.clinthera.2012.02.001']
992,32423706,The prognostic value of voiding chart data in therapy-resistant enuresis.,"INTRODUCTION


The case history is the primary tool when investigating the enuretic child. To further determine whether nocturnal polyuria or detrusor overactivity is present, a full voiding chart, is the method of choice. However, there is no robust evidence that daytime voiding chart data actually do predict nocturnal detrusor function.
AIM


The aim of this study was to assess the predictive value of anamnestic data and the voiding chart in the treatment of children with therapy-resistant enuresis.
PATIENTS AND METHODS


The patients all suffered from enuresis resistant to first-line therapy. None of the children had daytime incontinence. In accordance with international recommendations, the children were first treated with anticholinergics. If the therapeutic effect was not satisfactory dosage was adjusted and desmopressin was added. If sufficient treatment effect was not achieved, antidepressant therapy was tried next, combined with desmopressin if needed. Since this was an evaluation of clinical practice, not a randomized trial, treatment success was graded according to family satisfaction, not the actual frequency of wet nights. Thus, only children who reported that they were completely dry were regarded as full responders and those who stated that there was a substantial and useful reduction of wet nights were labeled intermediate responders.
RESULTS


In total, 154 patients were included. Few and inconsistent differences were found between the groups responding or not responding to the various treatment regimens, and this was true both for anamnestic and voiding chart data (see Table). The only statistically significant findings were that responders to antidepressant therapy were older (p = 0.013) than non-responders, and patients who benefited from addition of desmopressin had a higher micturition frequency than those who did not (p = 0.027). The children who needed desmopressin as part of combination treatment to become dry did not have significantly higher nocturnal urine production than those who had no such benefit (p = 0.619). Neither the presence of urgency nor a history of previous daytime incontinence was significantly more common in children responding to anticholinergics (p = 0.375 and 0.072, respectively).
DISCUSSION


No clear and consistent differences in either anamnestic factors or voiding chart data were found between the patients responding or not responding to the various treatment regimens. Not even urgency could predict anticholinergic efficacy. Somewhat surprisingly, no association between nocturnal polyuria and desmopressin benefit was found.
CONCLUSION


In this study no prognostic value was found in anamnestic or voiding chart data in children with therapy resistant enuresis.",2020,No clear and consistent differences in either anamnestic factors or voiding chart data were found between the patients responding or not responding to the various treatment regimens.,"['children with therapy resistant enuresis', '154 patients were included', 'children with therapy-resistant enuresis']","['anticholinergics', 'desmopressin']","['daytime incontinence', 'nocturnal polyuria and desmopressin benefit', 'presence of urgency nor a history of previous daytime incontinence', 'micturition frequency', 'nocturnal urine production', 'anticholinergic efficacy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0014394', 'cui_str': 'Enuresis'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}]","[{'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0848232', 'cui_str': 'Nocturnal polyuria'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",154.0,0.0265485,No clear and consistent differences in either anamnestic factors or voiding chart data were found between the patients responding or not responding to the various treatment regimens.,"[{'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Lundmark', 'Affiliation': 'Dept. of Women´s and Children´s Health, Uppsala University, Akademiska Barnsjukhuset, SE-751 85 Uppsala, Sweden. Electronic address: elisabet.lundmark@kbh.uu.se.'}, {'ForeName': 'Tryggve', 'Initials': 'T', 'LastName': 'Neve Us', 'Affiliation': 'Dept. of Women´s and Children´s Health, Uppsala University, Akademiska Barnsjukhuset, SE-751 85 Uppsala, Sweden.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.02.020']
993,31400077,Causal explanations of depression and treatment credibility in adults with untreated depression: Examining attribution theory.,"OBJECTIVES


Understanding depression as biologically caused has been shown to impact both treatment preferences and prognostic pessimism. Attribution theory has been posited as an explanation for this relationship. Given that evidence-based psychotherapy is effective yet often not delivered to individuals with depression, the present study sought to determine factors that impact treatment credibility.
DESIGN


Non-treatment-seeking, depressed individuals (n = 229) were randomly assigned to read a psychoeducation article about depression that consisted of a biological causal explanation, psychosocial causal explanation, or a non-causal control.
METHODS


Attributional dimensions of locus, stability, and control were examined as mediating the relationship between causal explanation and treatment credibility and prognostic pessimism.
RESULTS


Individuals in the biological condition were more likely to find antidepressant medication a credible treatment for depression. The manipulation had no direct effect on preference for psychotherapy or prognostic pessimism. Attributional dimensions of locus, stability, and control did not mediate the relationship between causal explanation and treatment credibility. To the extent that the psychosocial article increased perceived instability of the depression cause, however, prognostic pessimism was reduced.
CONCLUSIONS


The present study has implications for framing education about depression in mental health literacy programs and public awareness campaigns.
PRACTITIONER POINTS


This study found that conceptualizing depression as biologically caused increased the credibility of medication but not psychotherapy Participants reading a biological explanation of depression demonstrated an increase on some aspects of stigma and prognostic pessimism Emphasizing the person-environment interaction rather than biological causes decreased the perceived stability of depression which was associated with a decrease in prognostic pessimism.",2020,This study found that conceptualizing depression as biologically caused increased the credibility of medication but not psychotherapy Participants reading a biological explanation of depression demonstrated an increase on some aspects of stigma and prognostic pessimism Emphasizing the person-environment interaction rather than biological causes decreased the perceived stability of depression which was associated with a decrease in prognostic pessimism.,"['adults with untreated depression', 'Non-treatment-seeking, depressed individuals (n\xa0=\xa0229']","['psychoeducation article about depression that consisted of a biological causal explanation, psychosocial causal explanation, or a non-causal control']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0239839,This study found that conceptualizing depression as biologically caused increased the credibility of medication but not psychotherapy Participants reading a biological explanation of depression demonstrated an increase on some aspects of stigma and prognostic pessimism Emphasizing the person-environment interaction rather than biological causes decreased the perceived stability of depression which was associated with a decrease in prognostic pessimism.,"[{'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Zimmermann', 'Affiliation': 'Department of Psychology, University of Nevada, Reno, Nevada, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Papa', 'Affiliation': 'Department of Psychology, University of Nevada, Reno, Nevada, USA.'}]",Psychology and psychotherapy,['10.1111/papt.12247']
994,21808751,"Effects of orally disintegrating vs regular olanzapine tablets on body weight, eating behavior, glycemic and lipid indices, and gastrointestinal hormones: a randomized, open comparison in outpatients with bipolar depression.","BACKGROUND


This randomized, open-label trial aimed to compare the metabolic effects of olanzapine orally disintegrating tablets (ODT) and solid oral tablets (SOT) in bipolar depressed and mixed outpatients.
METHODS


Participants were openly randomized to receive olanzapine ODT (n = 13) or SOT (n = 10), 10 to 20 mg, once daily. Weight, body mass index (BMI), Food Craving Inventory (FCI), and Three-Factor Eating Questionnaire (3-FEQ) scores were assessed at baseline and at weeks 1, 2, 4, 6, and 8. Fasting glucose and lipid levels were assessed at baseline and at week 8. Insulin and leptin concentrations were measured just prior to olanzapine baseline dosing, 1 and 2 hours following administration of baseline dose, and at weeks 4 and 8.
RESULTS


Patients showed significant increases in weight, BMI, and leptin area under the concentration-time curve (AUC), but not in FCI or 3-FEQ scores, over 8 weeks of treatment with olanzapine ODT and SOT. However, no significant differences between olanzapine formulations (ODT vs SOT) were observed in any of the measures assessed, except for a significantly lower triglyceride concentration in the ODT group at week 8.
CONCLUSIONS


There was no consistent difference in metabolic profile between olanzapine ODT and SOT formulations during short-term treatment of bipolar depressed patients. Potential differences related to effects on triglyceride concentration warrant further confirmation.",2011,There was no consistent difference in metabolic profile between olanzapine ODT and SOT formulations during short-term treatment of bipolar depressed patients.,"['bipolar depressed and mixed outpatients', 'outpatients with bipolar depression', 'Participants', 'bipolar depressed patients']","['olanzapine', 'olanzapine orally disintegrating tablets (ODT) and solid oral tablets (SOT', 'olanzapine ODT', 'olanzapine ODT and SOT', 'orally disintegrating vs regular olanzapine tablets', 'SOT']","['Insulin and leptin concentrations', 'Weight, body mass index (BMI), Food Craving Inventory (FCI), and Three-Factor Eating Questionnaire (3-FEQ) scores', 'weight, BMI, and leptin area under the concentration-time curve (AUC', 'metabolic profile', 'FCI or 3-FEQ scores', 'triglyceride concentration', 'Fasting glucose and lipid levels', 'body weight, eating behavior, glycemic and lipid indices, and gastrointestinal hormones']","[{'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0993159', 'cui_str': 'Oral Tablet'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017182', 'cui_str': 'Gastrointestinal Hormones'}]",,0.0240939,There was no consistent difference in metabolic profile between olanzapine ODT and SOT formulations during short-term treatment of bipolar depressed patients.,"[{'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Bobo', 'Affiliation': 'Department of Psychiatry, Vanderbilt University School of Medicine, Nashville, TN 37212, USA. william.v.bobo@vanderbilt.edu'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Epstein', 'Affiliation': ''}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': ''}]",Annals of clinical psychiatry : official journal of the American Academy of Clinical Psychiatrists,[]
995,31540737,"Early Results of Our International, Multicenter, Multisurgeon, Double-Blinded, Prospective, Randomized, Controlled Trial Comparing Metal-on-Metal With Ceramic-on-Metal in Total Hip Arthroplasty.","BACKGROUND


The aim of our prospective, multicenter, randomized, controlled trial (titled M2A-38 Ceramic-on-Metal RCT, NCT00754520) is to demonstrate noninferiority of a ceramic-on-metal (CoM) articulation compared with metal-on-metal (MoM) in total hip arthroplasty. The study arms are at 8 years since implantation, with metal ion and functional score analysis at 5 years.
METHODS


We recruited 211 patients between 2009 and 2011. The patients were randomized to ceramic or metal. A cohort of these patients had whole blood metal ions performed yearly, and all patients underwent annual radiographic and clinical outcome assessment. All revisions were recorded and some explants were analyzed. Recruitment ceased earlier than planned owing to concerns raised with failure of MoM implants.
RESULTS


No significant difference was seen in patient demographics, radiographic parameters, or functional outcomes at any time point. Lower cobalt ion levels were seen in the CoM group (P < .01) at all time points. Chromium levels were significantly lower in the CoM group up to 3 years, but raised at 5 years. There were slightly fewer revisions for adverse reaction to metal debris in the CoM group. Explant analysis suggested a different wear pattern to those seen in the MoM group.
CONCLUSION


The results demonstrated that the CoM articulation behaved the same as the MoM in terms of functional outcome and radiographic parameters. The CoM coupling also demonstrates raised metal ions beyond 3 years and increasing revisions for adverse reaction to metal debris. It remains difficult to see a clinical application for CoM and further exploration or use is not warranted.",2020,Lower cobalt ion levels were seen in the CoM group (P < .01) at all time points.,"['Total Hip Arthroplasty', '211 patients between 2009 and 2011', 'total hip arthroplasty']","['metal-on-metal (MoM', 'ceramic or metal', 'Metal-on-Metal With Ceramic']","['Lower cobalt ion levels', 'patient demographics, radiographic parameters, or functional outcomes', 'Chromium levels', 'adverse reaction to metal debris']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0168430', 'cui_str': 'chromium hexavalent ion'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C1289927', 'cui_str': 'Metal (material)'}, {'cui': 'C0440266', 'cui_str': 'Debris (substance)'}]",211.0,0.095467,Lower cobalt ion levels were seen in the CoM group (P < .01) at all time points.,"[{'ForeName': 'Joanna E', 'Initials': 'JE', 'LastName': 'Higgins', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, North Hampshire Hospital (Hampshire Hospitals NHS Trust), Basingstoke, Hampshire, United Kingdom.'}, {'ForeName': 'Kevin S', 'Initials': 'KS', 'LastName': 'Conn', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, North Hampshire Hospital (Hampshire Hospitals NHS Trust), Basingstoke, Hampshire, United Kingdom.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Britton', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, North Hampshire Hospital (Hampshire Hospitals NHS Trust), Basingstoke, Hampshire, United Kingdom.'}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Pesola', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Central Finland Central Hospital, Jyvaskyla, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Manninen', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Kymenlaakso Central Hospital, Kotka, Finland.'}, {'ForeName': 'Geoff J', 'Initials': 'GJ', 'LastName': 'Stranks', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, North Hampshire Hospital (Hampshire Hospitals NHS Trust), Basingstoke, Hampshire, United Kingdom.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.08.002']
996,30221578,Does cognitive flexibility training enhance subjective mental functioning in healthy older adults?,"Declining cognitive abilities in older adults can contribute to significant changes in socioemotional health and substantially reduce their perception of well-being. Whereas much attention has been dedicated to creating cognitive training programs to improve cognitive health in old age, there is little emphasis on the consequences of such interventions for subjective mental functioning. We created a randomized controlled trial in which we evaluated the effects of an adaptive computerized cognitive flexibility training. Healthy older adults (60-80 years old) were assigned to one of three conditions (frequent or infrequent switching or active control group) and performed 58 half-hour sessions within a period of 12 weeks. We measured effects on subjective cognitive failures and executive dysfunctioning, everyday functioning, depressive symptoms, anxiety, and quality of life, before, and after training. Additionally, participants' proxies rated their cognitive failures and executive dysfunctioning. Subjective cognitive failures and executive dysfunctioning improved 4 weeks posttraining in all groups, although effect sizes were low ( ɳ p 2   = .058 and .079, respectively) and there were no differences between groups (all  p 's > .38). No significant changes in subjective reports were seen directly after training, which was the case in all groups. Proxies did not report any functional changes over time, yet their evaluations were significantly more favorable than those of the participants, both pretraining ( p  < .0005) and posttraining ( p  = .004). Although we found no evidence of improvement on subjective mental functioning, we adduce several factors that encourage further research into the effects of computerized cognitive training on subjective performance.",2019,"Subjective cognitive failures and executive dysfunctioning improved 4 weeks posttraining in all groups, although effect sizes were low (ɳ p 2  = .058 and .079, respectively) and there were no differences between groups (all p's > .38).","['Healthy older adults (60-80\xa0years old', 'healthy older adults', 'older adults']","['computerized cognitive training', 'adaptive computerized cognitive flexibility training', 'cognitive flexibility training']","['subjective mental functioning', 'Subjective cognitive failures and executive dysfunctioning', 'subjective reports', 'subjective performance', 'cognitive failures and executive dysfunctioning', 'subjective cognitive failures and executive dysfunctioning, everyday functioning, depressive symptoms, anxiety, and quality of life']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034380'}]",,0.0154634,"Subjective cognitive failures and executive dysfunctioning improved 4 weeks posttraining in all groups, although effect sizes were low (ɳ p 2  = .058 and .079, respectively) and there were no differences between groups (all p's > .38).","[{'ForeName': 'Jessika I V', 'Initials': 'JIV', 'LastName': 'Buitenweg', 'Affiliation': 'a Department of Psychology, University of Amsterdam , Amsterdam , The Netherlands.'}, {'ForeName': 'Renate M', 'Initials': 'RM', 'LastName': 'Van De Ven', 'Affiliation': 'a Department of Psychology, University of Amsterdam , Amsterdam , The Netherlands.'}, {'ForeName': 'K Richard', 'Initials': 'KR', 'LastName': 'Ridderinkhof', 'Affiliation': 'a Department of Psychology, University of Amsterdam , Amsterdam , The Netherlands.'}, {'ForeName': 'Jaap M J', 'Initials': 'JMJ', 'LastName': 'Murre', 'Affiliation': 'a Department of Psychology, University of Amsterdam , Amsterdam , The Netherlands.'}]","Neuropsychology, development, and cognition. Section B, Aging, neuropsychology and cognition",['10.1080/13825585.2018.1519106']
997,31953790,"Diroximel Fumarate Demonstrates an Improved Gastrointestinal Tolerability Profile Compared with Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis: Results from the Randomized, Double-Blind, Phase III EVOLVE-MS-2 Study.","BACKGROUND


Diroximel fumarate (DRF) is a novel oral fumarate approved in the USA for relapsing forms of multiple sclerosis. DRF is converted to monomethyl fumarate, the pharmacologically active metabolite of dimethyl fumarate (DMF). DRF 462 mg and DMF 240 mg produce bioequivalent exposure of monomethyl fumarate and are therefore expected to have similar efficacy/safety profiles; the distinct chemical structure of DRF may contribute to its tolerability profile.
OBJECTIVES


The objective of this study was to compare the gastrointestinal tolerability of DRF and DMF over 5 weeks in patients with relapsing-remitting multiple sclerosis.
METHODS


EVOLVE-MS-2 was a phase III, randomized, double-blind, head-to-head, 5-week study evaluating the gastrointestinal tolerability of DRF 462 mg vs DMF 240 mg, administered twice daily in patients with relapsing-remitting multiple sclerosis, using two self-administered gastrointestinal symptom scales: Individual Gastrointestinal Symptom and Impact Scale (IGISIS) and Global Gastrointestinal Symptom and Impact Scale (GGISIS). The primary endpoint was the number of days with an IGISIS intensity score ≥ 2 relative to exposure. Other endpoints included the degree of gastrointestinal symptom severity measured by IGISIS/GGISIS and assessment of safety/tolerability.
RESULTS


DRF-treated patients experienced a statistically significant reduction (46%) in the number of days with an IGISIS symptom intensity score ≥ 2 compared with DMF-treated patients (rate ratio [95% confidence interval]: 0.54 [0.39-0.75]; p = 0.0003). Lower rates of gastrointestinal adverse events (including diarrhea, nausea, vomiting, and abdominal pain) were observed with DRF than DMF (34.8% vs 49.0%). Fewer patients discontinued DRF than DMF because of adverse events (1.6% vs 5.6%) and gastrointestinal adverse events (0.8% vs 4.8%).
CONCLUSIONS


DRF demonstrated an improved gastrointestinal tolerability profile compared with DMF, with less severe gastrointestinal events and fewer days of self-assessed gastrointestinal symptoms, fewer gastrointestinal adverse events, and lower discontinuation rates because of gastrointestinal adverse events.
CLINICAL TRIALS REGISTRATION


ClinicalTrials.gov (NCT03093324).",2020,"Lower rates of gastrointestinal adverse events (including diarrhea, nausea, vomiting, and abdominal pain) were observed with DRF than DMF (34.8% vs 49.0%).","['patients with relapsing-remitting multiple sclerosis', 'Patients with Relapsing-Remitting Multiple Sclerosis']","['Diroximel fumarate (DRF', 'Diroximel Fumarate', 'DRF 462\xa0mg and DMF', 'DRF and DMF', 'Dimethyl Fumarate', 'DRF 462\xa0mg vs DMF']","['degree of gastrointestinal symptom severity measured by IGISIS/GGISIS and assessment of safety/tolerability', 'gastrointestinal adverse events', 'adverse events', 'gastrointestinal tolerability profile', 'Gastrointestinal Tolerability Profile', 'number of days with an IGISIS symptom intensity score', 'gastrointestinal symptom scales: Individual Gastrointestinal Symptom and Impact Scale (IGISIS) and Global Gastrointestinal Symptom and Impact Scale (GGISIS', 'severe gastrointestinal events and fewer days of self-assessed gastrointestinal symptoms, fewer gastrointestinal adverse events', 'gastrointestinal tolerability', 'number of days with an IGISIS intensity score\u2009≥\u20092 relative to exposure', 'gastrointestinal adverse events (including diarrhea, nausea, vomiting, and abdominal pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}]","[{'cui': 'C0220833', 'cui_str': 'fumarate'}, {'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}]",,0.106826,"Lower rates of gastrointestinal adverse events (including diarrhea, nausea, vomiting, and abdominal pain) were observed with DRF than DMF (34.8% vs 49.0%).","[{'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Naismith', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Wundes', 'Affiliation': 'Department of Neurology, University of Washington Medical Center, Seattle, WA, USA.'}, {'ForeName': 'Tjalf', 'Initials': 'T', 'LastName': 'Ziemssen', 'Affiliation': 'Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany.'}, {'ForeName': 'Elzbieta', 'Initials': 'E', 'LastName': 'Jasinska', 'Affiliation': 'Collegium Medicum UJK, and Clinical Center, RESMEDICA, Kielce, Poland.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Freedman', 'Affiliation': 'University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Lembo', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Selmaj', 'Affiliation': 'Center of Neurology, Lodz, Poland.'}, {'ForeName': 'Ilda', 'Initials': 'I', 'LastName': 'Bidollari', 'Affiliation': 'Alkermes Inc., Waltham, MA, USA.'}, {'ForeName': 'Hailu', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Biogen, 225 Binney St, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Hanna', 'Affiliation': 'Biogen, Maidenhead, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Leigh-Pemberton', 'Affiliation': 'Alkermes Inc., Waltham, MA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lopez-Bresnahan', 'Affiliation': 'Alkermes Inc., Waltham, MA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lyons', 'Affiliation': 'Biogen, 225 Binney St, Cambridge, MA, 02142, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Biogen, 225 Binney St, Cambridge, MA, 02142, USA. catherine.miller@biogen.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rezendes', 'Affiliation': 'Alkermes Inc., Waltham, MA, USA.'}, {'ForeName': 'Jerry S', 'Initials': 'JS', 'LastName': 'Wolinsky', 'Affiliation': 'Department of Neurology, McGovern Medical School, University of Texas Health Science Center at Houston (UTHealth), Houston, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",CNS drugs,['10.1007/s40263-020-00700-0']
998,31615196,"Using virtual reality-based training to improve cognitive function, instrumental activities of daily living and neural efficiency in older adults with mild cognitive impairment.","BACKGROUND


A combination of physical and cognitive training appears to be the effective intervention to improve cognitive function in older adults with mild cognitive impairment (MCI). Computing technology such as virtual reality (VR) may have the potential to assist rehabilitation in shaping brain health. However, little is known about the potential of VR-based physical and cognitive training designed as an intervention for cognition and brain activation in elderly patients with MCI. Moreover, whether a VR program designed around functional tasks can improve their instrumental activities of daily living (IADL) requires further investigation.
AIM


This study investigated the effects of 12 weeks of VR-based physical and cognitive training on cognitive function, brain activation and IADL and compared the VR intervention with combined physical and cognitive training.
DESIGN


A single-blinded randomized controlled trial.
SETTING


Communities and day care centers in Taipei, Taiwan.
POPULATION


Older adults with mild cognitive impairment.
METHODS


Thirty-four community-dwelling older adults with MCI were randomized into either a VR-based physical and cognitive training (VR) group or a combined physical and cognitive training (CPC) group for 36 sessions over 12 weeks. Participants were assessed for their cognitive function (global cognition, executive function and verbal memory) and IADL at pre- and postintervention. Changes in prefrontal cortex activation during the global cognition test were also captured by functional near-infrared spectroscopy (NIRS) to identify the potential mediating pathway of the intervention.
RESULTS


Both groups showed improved executive function and verbal memory (immediate recall). However, only the VR group showed significant improvements in global cognition (P<0.001), verbal memory (delayed recall, P=0.002), and IADL (P<0.001) after the intervention. The group × time interaction effects further demonstrated that IADL were more significantly improved with VR training than with CPC training (P=0.006). The hemodynamic data revealed decreased activation in prefrontal areas after training (P=0.0015), indicative of increased neural efficiency, in the VR-trained subjects.
CONCLUSIONS


VR-based physical and cognitive training improves cognitive function, IADL and neural efficiency in older adults with MCI.
CLINICAL REHABILITATION IMPACT


VR training could be implemented for older adults with MCI.",2020,The group×time interaction effects further demonstrated that IADL were more significantly improved with VR training than with CPC training (p=0.006).,"['older adults with mild cognitive impairment', 'Communities and day care centers in Taipei, Taiwan', 'older adults with MCI', 'older adults with mild cognitive impairment (MCI', 'elderly patients with MCI', 'Older adults with mild cognitive impairment', 'Thirty-four community-dwelling older adults with MCI']","['virtual reality-based training', 'physical and cognitive training', 'VR-based physical and cognitive training (VR) group or a combined physical and cognitive training (CPC', 'VR intervention with combined physical and cognitive training', 'VR-based physical and cognitive training']","['prefrontal cortex activation', 'executive function and verbal memory (immediate recall', 'cognitive function', 'global cognition(p<0.001), verbal memory (delayed recall, p=0.002), and IADL', 'neural efficiency', 'instrumental activities of daily living (IADL', 'cognitive function, instrumental activities of daily living and neural efficiency', 'cognitive function, IADL and neural efficiency', 'cognitive function (global cognition, executive function and verbal memory) and IADL at pre- and postintervention', 'cognitive function, brain activation and IADL']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0175952', 'cui_str': 'Day care center (environment)'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0056911', 'cui_str': ""cytidylyl-(3'-5')-cytidine""}]","[{'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}]",34.0,0.0089697,The group×time interaction effects further demonstrated that IADL were more significantly improved with VR training than with CPC training (p=0.006).,"[{'ForeName': 'Ying-Yi', 'Initials': 'YY', 'LastName': 'Liao', 'Affiliation': 'Department of Gerontological Health Care, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}, {'ForeName': 'Han-Yun', 'Initials': 'HY', 'LastName': 'Tseng', 'Affiliation': 'Department of Gerontological Health Care, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}, {'ForeName': 'Yi-Jia', 'Initials': 'YJ', 'LastName': 'Lin', 'Affiliation': 'Graduate Institute of Biomedical Engineering, National Taiwan University of Science and Technology, Taipei, Taiwan.'}, {'ForeName': 'Chung-Jen', 'Initials': 'CJ', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Cheng Hsin General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei-Chun', 'Initials': 'WC', 'LastName': 'Hsu', 'Affiliation': 'Graduate Institute of Biomedical Engineering, National Taiwan University of Science and Technology, Taipei, Taiwan - wchsu@mail.ntust.edu.tw.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.19.05899-4']
999,31304536,MSG-10: a Phase 2 study of oral ibrexafungerp (SCY-078) following initial echinocandin therapy in non-neutropenic patients with invasive candidiasis.,"OBJECTIVES


To evaluate the safety and efficacy of two dosing regimens of oral ibrexafungerp (formerly SCY-078), a novel orally bioavailable β-glucan synthase inhibitor, in subjects with invasive candidiasis versus the standard of care (SOC) and to identify the dose to achieve target exposure (15.4 μM·h) in >80% of the intended population.
METHODS


In a multinational, open-label study, patients with documented invasive candidiasis were randomized to receive step-down therapy to one of three treatment arms: two dosing regimens of novel oral ibrexafungerp or the SOC treatment following initial echinocandin therapy. Plasma samples were collected to evaluate exposure by population pharmacokinetic (PK) modelling. Safety was assessed throughout the study and global response at the end of treatment.
RESULTS


Out of 27 subjects enrolled, 7 received ibrexafungerp 500 mg, 7 received ibrexafungerp 750 mg and 8 received the SOC. Five did not meet criteria for randomization. Population PK analysis indicated that an ibrexafungerp 750 mg regimen is predicted to achieve the target exposure in ∼85% of the population. The rate of adverse events was similar among patients receiving ibrexafungerp or fluconazole. Similar favourable response rates were reported among all groups: 86% (n = 6) in the ibrexafungerp 750 mg versus 71% (n = 5) in both the fluconazole and ibrexafungerp 500 mg treatment arms. The one subject treated with continued micafungin had a favourable global response.
CONCLUSIONS


The oral ibrexafungerp dose estimated to achieve the target exposure in subjects with invasive candidiasis is 750 mg daily. This dose was well tolerated and achieved a favourable global response rate, similar to the SOC.",2019,Similar favourable response rates were reported among all groups: 86% (n = 6) in the ibrexafungerp 750 mg versus 71% (n = 5) in both the fluconazole and ibrexafungerp 500 mg treatment arms.,"['27 subjects enrolled, 7 received', 'patients with documented invasive candidiasis', 'subjects with invasive candidiasis versus the standard of care (SOC) and to identify the dose to achieve target exposure (15.4\u2009μM·h) in >80% of the intended population', 'non-neutropenic patients with invasive candidiasis', 'subjects with invasive candidiasis']","['echinocandin therapy', 'ibrexafungerp 500\u2009mg, 7 received ibrexafungerp 750\u2009mg and 8 received the SOC', 'novel oral ibrexafungerp or the SOC treatment following initial echinocandin therapy', 'MSG-10', 'oral ibrexafungerp (formerly SCY-078', 'fluconazole', 'oral ibrexafungerp (SCY-078']","['rate of adverse events', 'response rates', 'Safety', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C4517579', 'cui_str': '15.4 (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1268551', 'cui_str': 'Echinocandins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C4521594', 'cui_str': 'Senior Chief Petty Officer'}, {'cui': 'C4547381', 'cui_str': 'SCY-078'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",27.0,0.0240353,Similar favourable response rates were reported among all groups: 86% (n = 6) in the ibrexafungerp 750 mg versus 71% (n = 5) in both the fluconazole and ibrexafungerp 500 mg treatment arms.,"[{'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Spec', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Pullman', 'Affiliation': 'Mercury Street Medical, Butte, MT, USA.'}, {'ForeName': 'George R', 'Initials': 'GR', 'LastName': 'Thompson', 'Affiliation': 'University of California-Davis, Sacramento, CA, USA.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Powderly', 'Affiliation': 'Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Ellis H', 'Initials': 'EH', 'LastName': 'Tobin', 'Affiliation': 'Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Vazquez', 'Affiliation': 'Medical College of Georgia/Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Wring', 'Affiliation': 'Scynexis, Inc., Jersey City, NJ, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Angulo', 'Affiliation': 'Scynexis, Inc., Jersey City, NJ, USA.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Helou', 'Affiliation': 'Scynexis, Inc., Jersey City, NJ, USA.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Pappas', 'Affiliation': 'University of Alabama, Birmingham, AL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz277']
1000,31537375,Dilute Povidone-Iodine Solution Prevents Intraoperative Contamination of Sterile Water Basins During Total Joint Arthroplasty.,"BACKGROUND


Periprosthetic joint infection is a major complication of total joint arthroplasty (TJA). The intraoperative splash basin has been found to be a potential source of contamination. Although consensus recommendations against the use of splash basin have been made, splash basin use continues to be taught and utilized in practice. This study aims to investigate the effect of dilute betadine addition to the sterile water (SW) contents (0.02% solution) of the splash basin on contamination rates. This intervention could preserve the functionality and preferential use of the splash basin. The primary outcome of this study is the rate of splash basin contamination, with secondary outcomes of prevalence of culture speciation and mean operative times association with the rate of positive cultures.
METHODS


Patients undergoing primary TJA were enrolled in a randomized controlled trial with assignment to either the intervention/betadine group, in which dilute betadine was added to the standard SW splash basin, or the control/standard SW group. For a total cohort of 104 patients, a 120 mL aliquot sample of basin fluid was collected at incision (""preprocedure"") and closure (""postprocedure""). Samples were cultured and monitored for 48 hours for growth, with further testing as necessary to identify microbial speciation.
RESULTS


Of the final 100 postprocedure samples, 0 (0.0%) were positive in the betadine group, while there were 23 (47.9%) positive samples in the SW group (P < .001). Of the positive cultures, the most common species grown were coagulase-negative Staphylococcus, Corynebacterium, and Micrococcus. The mean operative time was an average of 11 minutes longer for cases with positive cultures.
CONCLUSION


In conclusion, treating SW splash basins with dilute povidone-iodine (0.02% solution) eliminates intraoperative contamination of splash basins in TJA procedures. This intervention is simple, low cost, and readily implementable, making it a reasonable addition to TJA protocols.
LEVEL OF EVIDENCE


Level 1, Controlled Laboratory Study.",2020,"The mean operative time was an average of 11 minutes longer for cases with positive cultures.
","['Patients undergoing primary TJA', '104 patients, a 120 mL aliquot sample of basin fluid was collected at incision (""preprocedure"") and closure (""postprocedure']","['dilute betadine', 'betadine', 'dilute betadine was added to the standard SW splash basin, or the control/standard SW group', 'Dilute Povidone-Iodine Solution', 'dilute povidone-iodine']","['rate of splash basin contamination, with secondary outcomes of prevalence of culture speciation and mean operative times association with the rate of positive cultures', 'Intraoperative Contamination of Sterile Water Basins', 'contamination rates', 'mean operative time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0179226', 'cui_str': 'Basin, device (physical object)'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]","[{'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0699524', 'cui_str': 'Betadine'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0179226', 'cui_str': 'Basin, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0179226', 'cui_str': 'Basin, device (physical object)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",104.0,0.101504,"The mean operative time was an average of 11 minutes longer for cases with positive cultures.
","[{'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nazal', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Total Joint Replacement, Wake Forest Baptist Health, Winston-Salem, NC.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Galloway', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Total Joint Replacement, Wake Forest Baptist Health, Winston-Salem, NC.'}, {'ForeName': 'Karanpreet K', 'Initials': 'KK', 'LastName': 'Dhaliwal', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Total Joint Replacement, Wake Forest Baptist Health, Winston-Salem, NC.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Nishiyama', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Total Joint Replacement, Wake Forest Baptist Health, Winston-Salem, NC.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Shields', 'Affiliation': 'Department of Orthopaedic Surgery, Center for Total Joint Replacement, Wake Forest Baptist Health, Winston-Salem, NC.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.08.016']
1001,31536624,"Comparison of Repeated Doses of Ivermectin Versus Ivermectin Plus Albendazole for the Treatment of Onchocerciasis: A Randomized, Open-label, Clinical Trial.","BACKGROUND


Improved treatment for onchocerciasis is needed to accelerate onchocerciasis elimination in Africa. Aiming to better exploit registered drugs, this study was undertaken to determine whether annual or semiannual treatment with ivermectin (IVM; 200 µg/kg) plus albendazole (ALB; 800 mg single dose) is superior to IVM alone.
METHODS


This trial was performed in Ghana and included 272 participants with microfilariae (MF), who were randomly assigned to 4 treatment arms: (1) IVM annually at 0, 12, and 24 months; (2) IVM semiannually at 0, 6, 12, 18, and 24 months; (3) IVM+ALB annually; or (4) IVM+ALB semiannually. Microfiladermia was determined pretreatment and at 6, 18, and 36 months. The primary outcome was the proportion of fertile and viable female worms in onchocercomata excised at 36 months.
RESULTS


Posttreatment nodule histology showed that 15/135 (11.1%), 22/155 (14.2%), 35/154 (22.7%), and 20/125 (16.0%) living female worms had normal embryogenesis in the IVM annual, IVM semiannual, IVM+ALB annual, and IVM+ALB semiannual groups, respectively (P = .1229). Proportions of dead worms also did not differ between the 4 groups (P = .9198). Proportions of patients without MF at 36 months (1 year after the last treatment) were 35/56 (63%) after annual IVM, 42/59 (71%) after semiannual IVM, 39/64 (61%) after annual IVM+ALB, and 43/53 (81%) after semiannual IVM+ALB.
CONCLUSIONS


The combination treatment of IVM plus ALB was no better than IVM alone for sterilizing, killing adult worms, or achieving sustained MF clearance. However, semiannual treatment was superior to annual treatment for achieving sustained clearance of Onchocerca volvulus MF from the skin (P = .024).
CLINICAL TRIALS REGISTRATION


ISRCTN50035143.",2020,"The combination treatment with IVM plus ALB was no better than IVM alone for sterilizing, killing of adult worms or achieving sustained MF clearance.",['Ghana and included 272 microfilaria (MF) -positive'],"['ivermectin (IVM; 200µg/kg) plus albendazole (ALB', 'ivermectin plus albendazole', 'IVM plus ALB', 'ivermectin']","['Microfiladermia', 'proportion of fertile and viable female worms in onchocercomata excised at 36 months']","[{'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0025980', 'cui_str': 'Microfilaria'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0912730', 'cui_str': 'aluminum boride'}]","[{'cui': 'C0443348', 'cui_str': 'Viable (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0018889', 'cui_str': 'Helminthiasis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.176554,"The combination treatment with IVM plus ALB was no better than IVM alone for sterilizing, killing of adult worms or achieving sustained MF clearance.","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Batsa Debrah', 'Affiliation': 'Kumasi Center for Collaborative Research, Kumasi, Ghana.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Klarmann-Schulz', 'Affiliation': 'Institute of Medical Microbiology, Immunology and Parasitology, University Hospital Bonn, Germany.'}, {'ForeName': 'Jubin', 'Initials': 'J', 'LastName': 'Osei-Mensah', 'Affiliation': 'Kumasi Center for Collaborative Research, Kumasi, Ghana.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Dubben', 'Affiliation': 'Institute of Medical Microbiology, Immunology and Parasitology, University Hospital Bonn, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Fischer', 'Affiliation': 'Infectious Diseases Division, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Yusif', 'Initials': 'Y', 'LastName': 'Mubarik', 'Affiliation': 'Kumasi Center for Collaborative Research, Kumasi, Ghana.'}, {'ForeName': 'Nana Kwame', 'Initials': 'NK', 'LastName': 'Ayisi-Boateng', 'Affiliation': 'University Hospital, , Kumasi, Ghana.'}, {'ForeName': 'Arcangelo', 'Initials': 'A', 'LastName': 'Ricchiuto', 'Affiliation': 'Institute of Medical Microbiology, Immunology and Parasitology, University Hospital Bonn, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Fimmers', 'Affiliation': 'Institute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Konadu', 'Affiliation': 'School of Medicine and Dentistry, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Nadal', 'Affiliation': 'Institute for Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gruetzmacher', 'Affiliation': 'Institute of Medical Microbiology, Immunology and Parasitology, University Hospital Bonn, Germany.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Weil', 'Affiliation': 'Infectious Diseases Division, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Kazura', 'Affiliation': 'Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'King', 'Affiliation': 'Center for Global Health and Diseases, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Alexander Y', 'Initials': 'AY', 'LastName': 'Debrah', 'Affiliation': 'Kumasi Center for Collaborative Research, Kumasi, Ghana.'}, {'ForeName': 'Achim', 'Initials': 'A', 'LastName': 'Hoerauf', 'Affiliation': 'Institute of Medical Microbiology, Immunology and Parasitology, University Hospital Bonn, Germany.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz889']
1002,31468714,"Revefenacin, a Long-Acting Muscarinic Antagonist, Does Not Prolong QT Interval in Healthy Subjects: Results of a Placebo- and Positive-Controlled Thorough QT Study.","Revefenacin is a novel once-daily, lung-selective, long-acting muscarinic antagonist developed as a nebulized inhalation solution for the maintenance treatment of chronic obstructive pulmonary disease. In a randomized, 4-way crossover study, healthy subjects received a single inhaled dose of revefenacin 175 µg (therapeutic dose), revefenacin 700 µg (supratherapeutic dose), and placebo via standard jet nebulizer, and a single oral dose of moxifloxacin 400 mg (open-label) in separate treatment periods. Electrocardiograms were recorded, and pharmacokinetic samples were collected serially after dosing. The primary end point was the placebo-corrected change from baseline QT interval corrected for heart rate using Fridericia's formula, analyzed at each postdose time. Concentration-QTc modeling was also performed. Following administration of revefenacin 175  and 700 µg, placebo-corrected change from baseline QTcF (ΔΔQTcF) values were close to 0 at all times, with the largest mean ΔΔQTcF of 1.0 millisecond (95% confidence interval [CI], -1.2 to 3.1 milliseconds) 8 hours postdose and 1.0 millisecond (95%CI, -1.1 to 3.1 milliseconds) 1 hour postdose after inhalation of revefenacin 175 and 700 µg, respectively. Revefenacin did not have a clinically meaningful effect on heart rate (within ±5 beats per minute of placebo), or PR and QRS intervals (within ±3 and ±1 milliseconds of placebo, respectively). Using concentration-QTc modeling, an effect of revefenacin > 10 milliseconds can be excluded within the observed plasma concentration range of up to ≈3 ng/mL. Both doses of revefenacin were well tolerated. These results demonstrate that revefenacin does not prolong the QT interval.",2020,"Revefenacin did not have a clinically meaningful effect on heart rate (within ±5 beats per minute of placebo), or PR and QRS intervals (within ±3 and ±1 milliseconds of placebo, respectively).","['Healthy Subjects', 'chronic obstructive pulmonary disease', 'healthy subjects']","['placebo', 'revefenacin 175\xa0µg (therapeutic dose), revefenacin 700\xa0µg (supratherapeutic dose), and placebo', 'moxifloxacin 400\xa0mg (open-label', 'Revefenacin', 'Placebo', 'revefenacin']","['baseline QTcF (ΔΔQTcF) values', 'placebo-corrected change from baseline QT interval corrected for heart rate', 'heart rate', 'tolerated', 'QT interval']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C1592286', 'cui_str': 'moxifloxacin 400 MG [Avelox]'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.428605,"Revefenacin did not have a clinically meaningful effect on heart rate (within ±5 beats per minute of placebo), or PR and QRS intervals (within ±3 and ±1 milliseconds of placebo, respectively).","[{'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Borin', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Chris N', 'Initials': 'CN', 'LastName': 'Barnes', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Borje', 'Initials': 'B', 'LastName': 'Darpo', 'Affiliation': 'ERT, previously iCardiac Technologies, Rochester, New York, USA.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Pendyala', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, California, USA.'}, {'ForeName': 'Hongqi', 'Initials': 'H', 'LastName': 'Xue', 'Affiliation': 'ERT, previously iCardiac Technologies, Rochester, New York, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Bourdet', 'Affiliation': 'Theravance Biopharma US, Inc., South San Francisco, California, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.732']
1003,31538488,Effectiveness of a peer support intervention for antenatal depression: a feasibility study.,"OBJECTIVE


A feasibility study for a randomised controlled trial to assess the acceptability, recruitment, feasibility and effectiveness of a peer support intervention for women with antenatal depression. The key premise of peer support is based upon the trust and empathetic understanding engendered by common experiences.
METHOD


Twenty pregnant women were recruited by their community midwife using the Whooley questionnaire at between 28-30 weeks' gestation to ascertain their level of mood and general mental health. Women identified as having potential antenatal depression were randomly assigned into a control group (routine care alone which includes contact with a midwife and in some case an obstetric Doctor with access to a GP if required) or intervention group (6-weekly visits from a peer support worker in addition to routine care). Participants from both the control and intervention group, and the Peer Support Workers (PSWs) were then interviewed at the end of the six-week period. All participants, and the PSW's, were also asked to keep log books during the trial to record their feelings and experiences. The results were then analysed using thematic analysis.
RESULTS


The analysis of qualitative data from the PSWs, and the participants in the intervention group, suggest the peer support intervention is acceptable, helpful and supportive to both pregnant women and, indeed, the PSWs. The women within the intervention group valued the peer support highly, reporting that being able to speak openly to a PSW meant that feelings of alienation, abnormality, isolation and stigma were replaced with social support, confidence, self-esteem and hope for recovery. The PSWs reported a positive impact upon their own wellbeing and a realisation that they had, indeed, moved forward with their lives. A proportion of the women randomised to the control group described feelings of disappointment and frustration with the lack of support currently available to them.
CONCLUSION


This feasibility study suggests a full randomised controlled trial (RCT) is warranted given the high recruitment, adherence, and acceptability of the intervention to participants.",2020,"A feasibility study for a randomised controlled trial to assess the acceptability, recruitment, feasibility and effectiveness of a peer support intervention for women with antenatal depression.","['women with antenatal depression', 'Women identified as having potential antenatal depression', ""Twenty pregnant women were recruited by their community midwife using the Whooley questionnaire at between 28-30\xa0weeks' gestation to ascertain their level of mood and general mental health"", 'antenatal depression']","['control group (routine care alone which includes contact with a midwife and in some case an obstetric Doctor with access to a GP if required) or intervention group (6-weekly visits from a peer support worker in addition to routine care', 'peer support intervention']","['acceptability, recruitment, feasibility and effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0401997', 'cui_str': 'Community midwife (occupation)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0424113', 'cui_str': 'Level of mood (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",20.0,0.0979689,"A feasibility study for a randomised controlled trial to assess the acceptability, recruitment, feasibility and effectiveness of a peer support intervention for women with antenatal depression.","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Carter', 'Affiliation': 'School of Health and Social Care, Staffordshire University , Stoke-on-Trent, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Cust', 'Affiliation': 'School of Health and Social Care, Staffordshire University , Stoke-on-Trent, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Boath', 'Affiliation': 'School of Health and Social Care, Staffordshire University , Stoke-on-Trent, United Kingdom of Great Britain and Northern Ireland.'}]",Journal of reproductive and infant psychology,['10.1080/02646838.2019.1668547']
1004,21134507,Good intentions: risk factors for unintended pregnancies in the US cohort of a microbicide trial.,"BACKGROUND


The study was conducted to assess socio-behavioral and biological factors associated with unplanned pregnancy in the US cohort of a microbicide trial.
STUDY DESIGN


We conducted a mixed-method, nested case-control study of risk factors for pregnancy within the US cohort of the microbicide trial HPTN 035. We developed an instrument to assess attitudes and beliefs about fertility control/contraceptive utilization among 122 women. Cases were HPTN 035 participants who became pregnant while enrolled, matched by time on study 1:4 with controls. Univariable and multivariable analysis were performed with pregnancy as the outcome of interest.
RESULTS


Contraceptive method change during the trial was associated with unplanned pregnancy (OR=1.76). Participant desire/partners' desire for future children (OR=4.95) and young age (OR=0.88 annually above age 19 years) were independently associated with unintended pregnancy.
CONCLUSION


Within a trial that enroll heterosexually active women, there may be ways to identify those at highest risk of becoming pregnant a priori.",2011,"Participant desire/partners' desire for future children (OR=4.95) and young age (OR=0.88 annually above age 19 years) were independently associated with unintended pregnancy.
","['Cases were HPTN 035 participants who became pregnant while enrolled, matched by time on study 1:4 with controls', ""Participant desire/partners' desire for future children (OR=4.95) and young age (OR=0.88 annually above age 19 years) were independently associated with unintended pregnancy"", '122 women']",[],['unplanned pregnancy'],"[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0041747', 'cui_str': 'Unintended Pregnancy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C0041747', 'cui_str': 'Unintended Pregnancy'}]",122.0,0.0728083,"Participant desire/partners' desire for future children (OR=4.95) and young age (OR=0.88 annually above age 19 years) were independently associated with unintended pregnancy.
","[{'ForeName': 'Courtney A', 'Initials': 'CA', 'LastName': 'Schreiber', 'Affiliation': 'University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA. cschreiber@obgyn.upenn.edu'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Whittington', 'Affiliation': ''}, {'ForeName': 'Liyi', 'Initials': 'L', 'LastName': 'Cen', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Maslankowski', 'Affiliation': ''}]",Contraception,['10.1016/j.contraception.2010.06.012']
1005,23047045,Zoledronic acid (zoledronate) for postmenopausal women with early breast cancer receiving adjuvant letrozole (ZO-FAST study): final 60-month results.,"BACKGROUND


Aromatase inhibitors are the preferred adjuvant endocrine therapy for the majority of postmenopausal women with hormone-responsive early breast cancer. Although generally more effective than tamoxifen, aromatase inhibitor therapy is associated with increased bone loss and fracture risk.
PATIENTS AND METHODS


Postmenopausal women receiving adjuvant letrozole (2.5 mg/day for 5 years; N = 1065) were randomly assigned to immediate zoledronic acid (zoledronate) 4 mg every 6 months for 5 years, or delayed zoledronate (initiated for fracture or on-study bone mineral density [BMD] decrease). The primary end point was the change in lumbar spine BMD at 12 months. Lumbar spine and total hip BMD at subsequent follow-up, disease-free survival (DFS), and overall survival were assessed as secondary end points.
RESULTS


At 60 months (final analysis), the mean change in lumbar spine BMD was +4.3% with immediate zoledronate and -5.4% with delayed intervention (P < 0.0001). Immediate zoledronate reduced the risk of DFS events by 34% (hazard ratio [HR] = 0.66; P = 0.0375) with fewer local (0.9% versus 2.3%) and distant (5.5% versus 7.7%) recurrences versus delayed zoledronate. In the delayed group, delayed initiation of zoledronate substantially improved DFS versus no zoledronate (HR = 0.46; P = 0.0334).
CONCLUSIONS


Immediate zoledronate in postmenopausal women receiving letrozole preserved BMD and is associated with improved DFS compared with letrozole alone. Clinical Trials Registration No NCT00171340.",2013,"In the delayed group, delayed initiation of zoledronate substantially improved DFS versus no zoledronate (HR = 0.46; P = 0.0334).
","['Postmenopausal women receiving', 'postmenopausal women with hormone-responsive early breast cancer', 'postmenopausal women with early breast cancer receiving adjuvant', 'postmenopausal women receiving', '2.5 mg/day for 5 years; N = 1065']","['immediate zoledronic acid (zoledronate) 4 mg every 6 months for 5 years, or delayed zoledronate', 'Zoledronic acid (zoledronate', 'letrozole', 'adjuvant letrozole', 'tamoxifen, aromatase inhibitor therapy']","['change in lumbar spine BMD', 'delayed initiation of zoledronate', 'bone loss and fracture risk', 'mean change in lumbar spine BMD', 'Lumbar spine and total hip BMD at subsequent follow-up, disease-free survival (DFS), and overall survival', 'risk of DFS events']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C4301709', 'cui_str': 'zoledronic acid 4 MG'}, {'cui': 'C0585339', 'cui_str': 'q6mo'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate (substance)'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0593802', 'cui_str': 'Aromatase Inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate (substance)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",1065.0,0.0330062,"In the delayed group, delayed initiation of zoledronate substantially improved DFS versus no zoledronate (HR = 0.46; P = 0.0334).
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Coleman', 'Affiliation': 'Academic Unit of Clinical Oncology, CR-UK/YCR Sheffield Cancer Research Centre, Sheffield, UK. Electronic address: r.e.coleman@sheffield.ac.uk.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'de Boer', 'Affiliation': 'Department of Medical Oncology, Royal Melbourne and Western Hospitals, Melbourne, Australia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Eidtmann', 'Affiliation': 'Clinic for Gynecology and Obstetrics, Universitäts-Frauenklinik Kiel, Kiel, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Llombart', 'Affiliation': 'Medical Oncology Service, Institute Oncologica, Valencia, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Davidson', 'Affiliation': 'Cancer Services Directorate, Broomfield Hospital, Chelmsford, Essex, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Neven', 'Affiliation': 'Department of Gynecological Oncology, Breast Clinic, UZ Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'German Breast Group, Frankfurt, Germany.'}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Sleeboom', 'Affiliation': 'Department of Internal Medicine, Haga Hospital, Den Haag, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Forbes', 'Affiliation': 'Faculty of Health, School of Medical Practice and Population Health, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Barrios', 'Affiliation': 'Faculty of Medicine, PUCRS School of Medicine, Porto Alegre, Brazil.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Frassoldati', 'Affiliation': 'Clinical Oncology Unit, St. Anna University Hospital, Ferrara, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Campbell', 'Affiliation': 'Department of General Surgery, Waikato Hospital, Breast Care Center, Hamilton, New Zealand.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Paija', 'Affiliation': 'Department of Medical Oncology, Turku University Central Hospital, Turku, Finland.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'Novartis Oncology, East Hanover, New Jersey, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Modi', 'Affiliation': 'Novartis Oncology, East Hanover, New Jersey, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bundred', 'Affiliation': 'Department of Academic Surgery, South Manchester University Hospital, Education and Research Center, Manchester, UK.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds277']
1006,32430167,Gamification in rehabilitation of metacarpal fracture using cost-effective end-user device: A randomized controlled trial.,"STUDY DESIGN


This is a two-group randomized controlled trial.
INTRODUCTION


Finger stiffness after treatment for metacarpal fractures often occurs due to poor compliance to the conventional rehabilitation programs. Gamification has shown success in improving adherence to and effectiveness of various therapies.
PURPOSE OF THE STUDY


The purpose of this study was to evaluate whether gamification, using cost-effective devices was comparable with conventional physiotherapy in improving hand functions and adherence to rehabilitation in metacarpal fractures.
METHODS


A 2-group randomized controlled trial involving 19 patients was conducted. Participants were randomized to a control (conventional physiotherapy, n = 10) or interventional group (gamification, n = 9). The grips strength and composite finger range of motion were measured at the baseline and each follow-up together with Patient-Rated Wrist and Hand Evaluation scores and compliance.
RESULTS


There were no significant differences on improvements of grip strength (means difference 24.38 vs 20.44, P = .289) and composite finger range of motion (means difference 50.50 vs 51.11, P = .886). However, the gamification group showed better results in Patient-Rated Wrist and Hand Evaluation (mean 0.44 vs 8.45, P = .038) and compliance (P < .05). No adverse events were reported.
DISCUSSION


Our results suggest that gamification using a cost-effective device demonstrated similar effectiveness as conventional physiotherapy in post-metacarpal fracture rehabilitation.
CONCLUSIONS


Gamification using a mobile device is an inexpensive and safe alternative to conventional physiotherapy for hand rehabilitation after metacarpal fractures. It effectively serves as a guide for future development of cost-effective technology-enhanced therapy.",2020,"There were no significant differences on improvements of grip strength (means difference 24.38 vs 20.44, P = .289) and composite finger range of motion (means difference 50.50 vs 51.11, P = .886).",['19 patients was conducted'],"['conventional physiotherapy', 'control (conventional physiotherapy, n\xa0=\xa010) or interventional group (gamification, n\xa0=\xa09']","['Patient-Rated Wrist and Hand Evaluation', 'composite finger range of motion', 'grip strength', 'adverse events', 'grips strength and composite finger range of motion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0575830', 'cui_str': 'Finger joint - range of movement'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",19.0,0.0811644,"There were no significant differences on improvements of grip strength (means difference 24.38 vs 20.44, P = .289) and composite finger range of motion (means difference 50.50 vs 51.11, P = .886).","[{'ForeName': 'Jun Wei', 'Initials': 'JW', 'LastName': 'Then', 'Affiliation': 'Faculty of Medicine, Department of Orthopaedic Surgery, National Orthopaedic Centre of Excellence for Research and Learning (NOCERAL), University Malaya, Kuala Lumpur, Malaysia. Electronic address: drjwthen_1004@yahoo.com.my.'}, {'ForeName': 'Sachin', 'Initials': 'S', 'LastName': 'Shivdas', 'Affiliation': 'Upper Limb & Reconstructive Microsurgery Unit, Faculty of Medicine, Department of Orthopaedic Surgery, National Orthopaedic Centre of Excellence for Research and Learning (NOCERAL), University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Tunku Sara', 'Initials': 'TS', 'LastName': 'Tunku Ahmad Yahaya', 'Affiliation': 'Upper Limb & Reconstructive Microsurgery Unit, Faculty of Medicine, Department of Orthopaedic Surgery, National Orthopaedic Centre of Excellence for Research and Learning (NOCERAL), University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nor Izzati', 'Initials': 'NI', 'LastName': 'Ab Razak', 'Affiliation': 'Upper Limb & Reconstructive Microsurgery Unit, Faculty of Medicine, Department of Orthopaedic Surgery, National Orthopaedic Centre of Excellence for Research and Learning (NOCERAL), University Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Pee Terh', 'Initials': 'PT', 'LastName': 'Choo', 'Affiliation': 'Department of Orthopaedic Surgery, Hospital Sultanah Bahiyah, Alor Setar, Kedah, Malaysia.'}]",Journal of hand therapy : official journal of the American Society of Hand Therapists,['10.1016/j.jht.2020.03.029']
1007,19996977,A placebo-controlled trial of 10-day bismuth-based quadruple therapy to eradicate Helicobacter pylori infection; a pilot study for the large Linqu County trial.,"AIM


To explore a low-cost and highly-effective therapy for eradication of Helicobacter pylori (H. pylori), a placebo-controlled trial of quadruple therapy was conducted in a population at high risk of gastric cancer in Linqu County of Shandong Province, China.
METHODS


Two hundred and seventy-seven adults aged 35-54 years with H. pylori infection in three villages were assigned to two groups: treatment (n=189 in two villages) and placebo (n=88 in one village). Participants received either a 10-day oral quadruple therapy regimen with omeprazole (20 mg, twice daily); tetracycline (750 mg, three times daily); metronidazole (500 mg, three times daily) and bismuth potassium citrate (300 mg, twice daily), or a similar lookalike placebo regimen. The status of H. pylori infection in each trial participant before and after six weeks of treatment was determined by a 13C-urea breath test.
RESULTS


One hundred and seventy-four of 189 participants completed the quadruple therapy (92.1%) and 84 participants completed the placebo therapy (95.5%). The H. pylori eradication rate by intention-to-treat analysis was 76.7% (145 of 189) in the treatment group and 1.1% (1 of 88) in the placebo group, respectively; by per-protocol analysis it was 83.3% (145 of 174) in the treatment group and 1.2% (1 of 84) in the placebo group, respectively.
CONCLUSION


In a high-risk area of gastric cancer, we conducted a high compliance, tolerable, low side-effect and lowcost therapy of anti-H. pylori. The eradication rate of the 10-day quadruple treatment was more than 80% and significantly higher than the triple therapy regimen used in this population in an earlier trial.",2010,"The H. pylori eradication rate by intention-to-treat analysis was 76.7% (145 of 189) in the treatment group and 1.1% (1 of 88) in the placebo group, respectively; by per-protocol analysis it was 83.3% (145 of 174) in the treatment group and 1.2% (1 of 84) in the placebo group, respectively.
","['a population at high risk of gastric cancer in Linqu County of Shandong Province, China', 'Two hundred and seventy-seven adults aged 35-54 years with H. pylori infection in three villages', 'One hundred and seventy-four of 189 participants completed the quadruple therapy (92.1%) and 84 participants completed the']","['omeprazole', 'placebo', 'tetracycline', '10-day bismuth-based quadruple therapy', 'bismuth potassium citrate', 'metronidazole']","['eradication rate', 'Helicobacter pylori infection', 'pylori eradication rate', 'status of H. pylori infection']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039651', 'cui_str': 'Tetracyclines'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0137996', 'cui_str': 'potassium citrate'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",3.0,0.279129,"The H. pylori eradication rate by intention-to-treat analysis was 76.7% (145 of 189) in the treatment group and 1.1% (1 of 88) in the placebo group, respectively; by per-protocol analysis it was 83.3% (145 of 174) in the treatment group and 1.2% (1 of 84) in the placebo group, respectively.
","[{'ForeName': 'Junling', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translation Research (Ministry of Education), Department of Epidemiology, Peking University School of Oncology, Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Hongjun', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Winawer', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Zauber', 'Affiliation': ''}, {'ForeName': 'Meinhard', 'Initials': 'M', 'LastName': 'Classen', 'Affiliation': ''}, {'ForeName': 'Weicheng', 'Initials': 'W', 'LastName': 'You', 'Affiliation': ''}]",European journal of gastroenterology & hepatology,['10.1097/MEG.0b013e3283337146']
1008,23553060,"Comparing normal saline versus diluted heparin to lock non-valved totally implantable venous access devices in cancer patients: a randomised, non-inferiority, open trial.","BACKGROUND


Heparin has been used for years as a locking solution in totally implantable venous access devices. Normal saline (NS) might be a safe alternative for heparin. However, evidence of non-inferiority of NS versus heparin is lacking.
PATIENTS AND METHODS


We randomly allocated 802 cancer patients with a newly inserted port either to heparin lock (300 U/3 ml) or to NS lock groups in a 1:1 assignment ratio. The primary outcome was the number of functional complications, which was defined as 'easy injection, impossible aspiration' at port access. Secondary outcomes included all functional problems and catheter-related bacteraemia. We hypothesised that NS locks do not cause more functional problems and catheter-related bacteraemia than heparin locks. Non-inferiority is established if the upper limit of the confidence interval (CI) for the relative risk of NS versus heparin is <1.4.
RESULTS


Three hundred and eighty-two patients from the NS group and 383 from the heparin lock group were included in the analysis. The incidence rate of our primary outcome (easy injection, impossible aspiration) was 3.70% (95% CI 2.91%-4.69%) and 3.92% (95% CI 3.09%-4.96%) of accesses in the NS and heparin groups, respectively. The relative risk was 0.94% (95% CI 0.67%-1.32%). Catheter-related bloodstream infection was 0.03 per 1000 catheter days in the NS group and 0.10 per 1000 catheter days in the heparin group.
CONCLUSION


NS is a safe and effective locking solution in implantable ports if combined with a strict protocol for device insertion and maintenance.",2013,We hypothesised that NS locks do not cause more functional problems and catheter-related bacteraemia than heparin locks.,"['Three hundred and eighty-two patients from the NS group and 383 from the heparin lock group were included in the analysis', 'cancer patients', 'We randomly allocated 802 cancer patients with a newly inserted port either to']","['normal saline versus diluted heparin to lock non-valved totally implantable venous access devices', 'heparin lock (300 U/3 ml) or to NS lock', 'Heparin', 'heparin', 'Normal saline (NS']","['relative risk', 'incidence rate of our primary outcome (easy injection, impossible aspiration', 'functional problems and catheter-related bacteraemia', ""number of functional complications, which was defined as 'easy injection, impossible aspiration' at port access"", 'Catheter-related bloodstream infection']","[{'cui': 'C4517750', 'cui_str': 'Three hundred and eighty-two'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}]","[{'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0332219', 'cui_str': 'Easy (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0452253', 'cui_str': 'Port (substance)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}]",802.0,0.433392,We hypothesised that NS locks do not cause more functional problems and catheter-related bacteraemia than heparin locks.,"[{'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Goossens', 'Affiliation': 'Nursing Centre of Excellence, University Hospitals Leuven, Leuven; Department of Public Health and Primary Care, KU Leuven, Leuven. Electronic address: godelieve.goossens@uzleuven.be.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jérôme', 'Affiliation': 'Nursing Centre of Excellence, University Hospitals Leuven, Leuven.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Janssens', 'Affiliation': 'Nursing Centre of Excellence, University Hospitals Leuven, Leuven.'}, {'ForeName': 'W E', 'Initials': 'WE', 'LastName': 'Peetermans', 'Affiliation': 'Department of Internal Medicine, University Hospitals Leuven, Leuven.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fieuws', 'Affiliation': 'Interuniversity Centre for Biostatistics and Statistical Bioinformatics, KU Leuven, Leuven; Interuniversity Centre for Biostatistics and Statistical Bioinformatics, Universiteit Hasselt, Hasselt.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Moons', 'Affiliation': 'Department of Public Health and Primary Care, KU Leuven, Leuven.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Verschakelen', 'Affiliation': 'Department of Radiology, University Hospitals Leuven, Leuven.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Peerlinck', 'Affiliation': 'Centre for Molecular and Vascular Biology, KU Leuven, Leuven.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jacquemin', 'Affiliation': 'Centre for Molecular and Vascular Biology, KU Leuven, Leuven.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stas', 'Affiliation': 'Department of Surgical Oncology, University Hospitals Leuven, Leuven, Belgium.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt114']
1009,31448819,In reference to Dexmedetomidine versus propofol at different sedation depths during drug-induced sleep endoscopy: A randomized trial.,,2020,,[],"['Dexmedetomidine', 'propofol']",[],[],"[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]",[],,0.0388472,,"[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cammaroto', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Gobbi', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'De Vito', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Meccariello', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Giannicola', 'Initials': 'G', 'LastName': 'Iannella', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Vicini', 'Affiliation': 'Unit of Otolaryngology, Hospital Morgagni Pierantoni, Forlì, Italy.'}]",The Laryngoscope,['10.1002/lary.28261']
1010,20522167,Parenteral insulin suppresses T cell proliferation to islet antigens.,"The diabetes prevention trial-type 1 (DPT-1) tested whether a combination of SQ and IV insulin therapy would delay the onset of disease in individuals at high risk of progression. We investigated whether this regimen altered T cell responses to human islet proteins using cellular immunoblotting. Among the 10 treated and 7 control subjects studied, we found that there was a significant effect of treatment on cellular immunoblotting responses. We conclude that parenteral insulin may suppress proliferation to islet antigens in individuals at risk for diabetes, but this effect may be transient. Further study is needed to determine whether a therapy that results in sustained suppression of T cell proliferation could yield a measurable clinical benefit.",2011,"Among the 10 treated and 7 control subjects studied, we found that there was a significant effect of treatment on cellular immunoblotting responses.","['individuals at risk for diabetes', 'individuals at high risk of progression']","['parenteral insulin', 'SQ and IV insulin therapy', 'Parenteral insulin']",['cellular immunoblotting responses'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]","[{'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0020985', 'cui_str': 'Immunoblotting'}]",,0.0465837,"Among the 10 treated and 7 control subjects studied, we found that there was a significant effect of treatment on cellular immunoblotting responses.","[{'ForeName': 'Carla J', 'Initials': 'CJ', 'LastName': 'Greenbaum', 'Affiliation': 'Benaroya Research Institute, Seattle, WA, USA. cjgreen@benaroyaresearch.org'}, {'ForeName': 'Marli', 'Initials': 'M', 'LastName': 'McCulloch-Olson', 'Affiliation': ''}, {'ForeName': 'Harvey K', 'Initials': 'HK', 'LastName': 'Chiu', 'Affiliation': ''}, {'ForeName': 'Jerry P', 'Initials': 'JP', 'LastName': 'Palmer', 'Affiliation': ''}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Brooks-Worrell', 'Affiliation': ''}]",Pediatric diabetes,['10.1111/j.1399-5448.2010.00674.x']
1011,31578572,Beta-blockers in heart failure patients with severe chronic kidney disease-time for a randomized controlled trial?,,2020,,['heart failure patients with severe chronic kidney disease-time'],['Beta-blockers'],[],"[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]",[],,0.0510105,,"[{'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Agarwal', 'Affiliation': 'Department of Medicine, Division of Nephrology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': 'University of Lorraine, Inserm 1433 CIC-P CHRU de Nancy, Inserm U1116 and FCRIN INI-CRCT, Nancy, France.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfz187']
1012,32066536,"Effect of fixed-dose subcutaneous reslizumab on asthma exacerbations in patients with severe uncontrolled asthma and corticosteroid sparing in patients with oral corticosteroid-dependent asthma: results from two phase 3, randomised, double-blind, placebo-controlled trials.","BACKGROUND


Reslizumab 3 mg/kg administered intravenously is approved for the treatment of severe eosinophilic asthma. We assessed the safety and efficacy of subcutaneous reslizumab 110 mg in two trials in patients with uncontrolled severe asthma and increased blood eosinophils. The aim was to establish whether subcutaneous reslizumab 110 mg can reduce exacerbation rates in these patients (study 1) or reduce maintenance oral corticosteroid dose in patients with corticosteroid-dependent asthma (study 2).
METHODS


Both studies were randomised, double-blind, placebo-controlled, phase 3 studies. Entry criteria for study 1 were uncontrolled severe asthma, two or more asthma exacerbations in the previous year, a blood eosinophil count of 300 cells per μL or more (including no more than 30% patients with an eosinophil count <400 cells/μL), and at least a medium dose of inhaled corticosteroids with one or more additional asthma controllers. Patients in study 2 had severe asthma, a blood eosinophil count of 300 cells per μL or more, daily maintenance oral corticosteroid (prednisone 5-40 mg, or equivalent), and high-dose inhaled corticosteroids plus another controller. Patients were randomly assigned (1:1) to subcutaneous reslizumab (110 mg) or placebo once every 4 weeks for 52 weeks in study 1 and 24 weeks in study 2. Patients and investigators were masked to treatment assignment. Primary efficacy outcomes were frequency of exacerbations during 52 weeks in study 1 and categorised percentage reduction in daily oral corticosteroid dose from baseline to weeks 20-24 in study 2. Primary efficacy analyses were by intention to treat, and safety analyses included all patients who received at least one dose of study treatment. These studies are registered with ClinicalTrials.gov, NCT02452190 (study 1) and NCT02501629 (study 2).
FINDINGS


Between Aug 12, 2015, and Jan 31, 2018, 468 patients in study 1 were randomly assigned to placebo (n=232) or subcutaneous reslizumab (n=236), and 177 in study 2 to placebo (n=89) or subcutaneous reslizumab (n=88). In study 1, we found no significant difference in the exacerbation rate between reslizumab and placebo in the intention-to-treat population (rate ratio 0·79, 95% CI 0·56-1·12; p=0·19). Subcutaneous reslizumab reduced exacerbation frequency compared with placebo in the subgroup of patients with blood eosinophil counts of 400 cells per μL or more (0·64, 95% CI 0·43-0·95). Greater reductions in annual exacerbation risk (p=0·0035) and longer time to first exacerbation were observed for patients with higher trough serum reslizumab concentrations. In study 2, we found no difference between placebo and fixed-dose subcutaneous reslizumab in categorised percentage reduction in daily oral corticosteroid dose (odds ratio for a lower category of oral corticosteroid use in the reslizumab group vs the placebo group, 1·23, 95% CI 0·70-2·16; p=0·47). The frequency of adverse events and serious adverse events with reslizumab were similar to those with placebo in both studies.
INTERPRETATION


Fixed-dose (110 mg) subcutaneous reslizumab was not effective in reducing exacerbation frequency in patients with uncontrolled asthma and increased blood eosinophils (≥300 cells/μL), or in reducing the daily maintenance oral corticosteroid dose in patients with oral corticosteroid-dependent severe eosinophilic asthma. Higher exposures than those observed with 110 mg subcutaneous reslizumab are required to achieve maximal efficacy.
FUNDING


Teva Branded Pharmaceutical Products R&D.",2020,Greater reductions in annual exacerbation risk (p=0·0035) and longer time to first exacerbation were observed for patients with higher trough serum reslizumab concentrations.,"['468 patients in study 1', 'patients with uncontrolled asthma and increased blood eosinophils (≥300 cells/μL), or in reducing the daily maintenance oral corticosteroid dose in patients with oral corticosteroid-dependent severe eosinophilic asthma', 'severe eosinophilic asthma', 'patients with uncontrolled severe asthma and increased blood eosinophils', 'patients with severe uncontrolled asthma and corticosteroid sparing in patients with oral corticosteroid-dependent asthma', 'Patients in study 2 had severe asthma, a blood eosinophil count of 300 cells per μL or more, daily maintenance oral corticosteroid (prednisone 5-40 mg, or equivalent), and high-dose inhaled corticosteroids plus another controller', 'Between Aug 12, 2015, and Jan 31, 2018', 'Entry criteria for study 1 were uncontrolled severe asthma, two or more asthma exacerbations in the previous year, a blood eosinophil count of 300 cells per μL or more (including no more than 30% patients with an eosinophil count <400 cells/μL), and at least a medium dose of inhaled corticosteroids with one or more additional asthma controllers', 'patients with corticosteroid-dependent asthma (study 2']","['reslizumab and placebo', 'placebo', 'reslizumab', 'fixed-dose subcutaneous reslizumab', 'subcutaneous reslizumab']","['frequency of exacerbations', 'frequency of adverse events and serious adverse events', 'asthma exacerbations', 'exacerbation rates', 'safety and efficacy', 'exacerbation rate', 'maximal efficacy', 'annual exacerbation risk (p=0·0035) and longer time to first exacerbation', 'exacerbation frequency']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0034068', 'cui_str': 'Pulmonary Eosinophilia'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count - observation'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}]","[{'cui': 'C1869620', 'cui_str': 'reslizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.700246,Greater reductions in annual exacerbation risk (p=0·0035) and longer time to first exacerbation were observed for patients with higher trough serum reslizumab concentrations.,"[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Bernstein', 'Affiliation': 'Department of Internal Medicine, Division of Immunology/Allergy Section, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Bernstein Clinical Research Center, Cincinnati, OH, USA. Electronic address: bernstja@ucmail.uc.edu.'}, {'ForeName': 'J Christian', 'Initials': 'JC', 'LastName': 'Virchow', 'Affiliation': 'Departments of Pulmonary Medicine and Intensive Care Medicine, Universitätsmedizin Rostock, Rostock, Germany.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murphy', 'Affiliation': 'Allergy, Asthma and Pulmonary Research, Boys Town National Research Hospital, Boys Town, NE, USA.'}, {'ForeName': 'Jorge Fernando', 'Initials': 'JF', 'LastName': 'Maspero', 'Affiliation': 'Allergy and Respiratory Research Unit, Fundación CIDEA, Buenos Aires, Argentina.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Jacobs', 'Affiliation': 'Allergy and Asthma Clinical Research, Walnut Creek, CA, USA.'}, {'ForeName': 'Yochai', 'Initials': 'Y', 'LastName': 'Adir', 'Affiliation': 'Pulmonary Division, Lady Davis Carmel Medical Center, Faculty of Medicine, The Technion, Institute of Technology, Haifa, Israel.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Humbert', 'Affiliation': 'Université Paris-Saclay, Assistance Publique-Hôpitaux de Paris, Service de Pneumologie, Hôpital Bicêtre, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Douglas A', 'Initials': 'DA', 'LastName': 'Marsteller', 'Affiliation': 'Teva Branded Pharmaceutical Products, West Chester, PA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McElhattan', 'Affiliation': 'Teva Branded Pharmaceutical Products, West Chester, PA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hickey', 'Affiliation': 'Teva Branded Pharmaceutical Products, West Chester, PA, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Garin', 'Affiliation': 'Teva Branded Pharmaceutical Products, West Chester, PA, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Vanlandingham', 'Affiliation': 'Teva Branded Pharmaceutical Products, West Chester, PA, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Brusselle', 'Affiliation': 'Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium; Departments of Epidemiology and Respiratory Medicine, Erasmus MC-University Medical Center Rotterdam, Rotterdam, Netherlands.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30372-8']
1013,31531707,Co-ingestion of whey protein hydrolysate with milk minerals rich in calcium potently stimulates glucagon-like peptide-1 secretion: an RCT in healthy adults.,"PURPOSE


To examine whether calcium type and co-ingestion with protein alter gut hormone availability.
METHODS


Healthy adults aged 26 ± 7 years (mean ± SD) completed three randomized, double-blind, crossover studies. In all studies, arterialized blood was sampled postprandially over 120 min to determine GLP-1, GIP and PYY responses, alongside appetite ratings, energy expenditure and blood pressure. In study 1 (n = 20), three treatments matched for total calcium content (1058 mg) were compared: calcium citrate (CALCITR); milk minerals rich in calcium (MILK MINERALS); and milk minerals rich in calcium plus co-ingestion of 50 g whey protein hydrolysate (MILK MINERALS + PROTEIN). In study 2 (n = 6), 50 g whey protein hydrolysate (PROTEIN) was compared to MILK MINERALS + PROTEIN. In study 3 (n = 6), MILK MINERALS was compared to the vehicle of ingestion (water plus sucralose; CONTROL).
RESULTS


MILK MINERALS + PROTEIN increased GLP-1 incremental area under the curve (iAUC) by ~ ninefold (43.7 ± 11.1 pmol L -1  120 min; p < 0.001) versus both CALCITR and MILK MINERALS, with no difference detected between CALCITR (6.6 ± 3.7 pmol L -1  120 min) and MILK MINERALS (5.3 ± 3.5 pmol L -1  120 min; p > 0.999). MILK MINERALS + PROTEIN produced a GLP-1 iAUC ~ 25% greater than PROTEIN (p = 0.024; mean difference: 9.1 ± 6.9 pmol L -1  120 min), whereas the difference between MILK MINERALS versus CONTROL was small and non-significant (p = 0.098; mean difference: 4.2 ± 5.1 pmol L -1  120 min).
CONCLUSIONS


When ingested alone, milk minerals rich in calcium do not increase GLP-1 secretion compared to calcium citrate. Co-ingesting high-dose whey protein hydrolysate with milk minerals rich in calcium increases postprandial GLP-1 concentrations to some of the highest physiological levels ever reported. Registered at ClinicalTrials.gov: NCT03232034, NCT03370484, NCT03370497.",2020,"MILK MINERALS + PROTEIN produced a GLP-1 iAUC ~ 25% greater than PROTEIN (p = 0.024; mean difference: 9.1 ± 6.9 pmol L -1  120 min), whereas the difference between MILK MINERALS versus CONTROL was small and non-significant (p = 0.098; mean difference: 4.2 ± 5.1 pmol ","['Healthy adults aged 26\u2009±\u20097\xa0years (mean\u2009±\u2009SD', 'healthy adults', '50']","['calcium citrate (CALCITR); milk minerals rich in calcium (MILK MINERALS); and milk minerals rich in calcium plus', 'L -1', 'total calcium content', 'pmol\xa0L -1']","['increased GLP-1 incremental area under the curve (iAUC', 'GLP-1 secretion', 'GLP-1, GIP and PYY responses, alongside appetite ratings, energy expenditure and blood pressure']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0108101', 'cui_str': 'Calcium Citrate'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0673362', 'cui_str': 'L-1 (ester)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0439192', 'cui_str': 'pmol'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0070358', 'cui_str': 'PYY Peptide'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.024686,"MILK MINERALS + PROTEIN produced a GLP-1 iAUC ~ 25% greater than PROTEIN (p = 0.024; mean difference: 9.1 ± 6.9 pmol L -1  120 min), whereas the difference between MILK MINERALS versus CONTROL was small and non-significant (p = 0.098; mean difference: 4.2 ± 5.1 pmol ","[{'ForeName': 'Yung-Chih', 'Initials': 'YC', 'LastName': 'Chen', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Harry A', 'Initials': 'HA', 'LastName': 'Smith', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Hengist', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Chrzanowski-Smith', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Ulla Ramer', 'Initials': 'UR', 'LastName': 'Mikkelsen', 'Affiliation': 'Arla Foods Ingredients Group P/S, Viby J, Denmark.'}, {'ForeName': 'Harriet A', 'Initials': 'HA', 'LastName': 'Carroll', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Saunders', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, BA2 7AY, UK. J.T.Gonzalez@bath.ac.uk.'}]",European journal of nutrition,['10.1007/s00394-019-02092-4']
1014,32067381,Can postoperative dexamethasone nanoparticle eye drops replace mitomycin C in trabeculectomy?,"PURPOSE


Compare (a) nonmitomycin C (MMC) trabeculectomy and 1.5% dexamethasone nanoparticle (DexNP) eye drops postoperatively with (b) trabeculectomy with MMC and Maxidex ®  eye drops postoperatively.
METHODS


Randomized prospective single masked clinical trial with 20 patients with primary open-angle glaucoma undergoing primary trabeculectomy. The study group consisted of 10 patients without MMC intraoperatively and postoperative DexNP eye drops, and the control group consisted of 10 patients treated with MMC intraoperatively and postoperative Maxidex ®  . The drops were tapered out over 8 weeks. The main outcome measures were as follows: rates of complete success, that is intraocular pressure (IOP) within target pressures at different time-points without IOP-lowering medication, or reoperation. Secondary outcome measures included the following: relative success rate (with IOP-lowering medications), number of glaucoma medications and reoperations. Patients were followed for 36 months.
RESULTS


Both groups showed similar postoperative course and IOP reduction. Intraocular pressures (IOPs) in the DexNP group and in the control group were 25.6 and 24.4 mmHg, respectively, at baseline. Intraocular pressures (IOPs) were reduced to 13.2 and 14.5 mmHg at 12 months, 11.7 and 12.6 mmHg at 24 months and 11.7 and 12.1 mmHg at 36 months, respectively. There were no statistically significant differences between the groups in absolute (p = 0.36) or relative (p = 1.0) success rates, number of medications (p = 0.71) or reoperations (p = 1.0) between the groups at any time-point.
CONCLUSIONS


DexNP eye drops are effective postoperative treatment following trabeculectomy. The potent anti-inflammatory and antifibrotic effect of DexNP may offer an alternative to mitomycin C in glaucoma surgery.",2020,"There were no statistically significant differences between the groups in absolute (p = 0.36) or relative (p = 1.0) success rates, number of medications (p = 0.71) or reoperations (p = 1.0) between the groups at any time-point.
","['glaucoma surgery', '20 patients with primary open-angle glaucoma undergoing primary trabeculectomy', '10 patients without']","['MMC intraoperatively and postoperative Maxidex ®  ', 'DexNP) eye drops postoperatively with (b) trabeculectomy with MMC and Maxidex ®', 'MMC intraoperatively and postoperative DexNP eye drops', 'mitomycin C', 'nonmitomycin C (MMC) trabeculectomy and 1.5% dexamethasone nanoparticle', 'dexamethasone nanoparticle eye drops replace mitomycin C', 'DexNP']","['postoperative course and IOP reduction', 'follows: rates of complete success, that is intraocular pressure (IOP) within target pressures at different time-points without IOP-lowering medication, or reoperation', 'Intraocular pressures (IOPs', 'relative success rate (with IOP-lowering medications), number of glaucoma medications and reoperations', 'success rates, number of medications']","[{'cui': 'C1706188', 'cui_str': 'Glaucoma surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0339573', 'cui_str': 'Chronic Primary Open Angle Glaucoma'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0701254', 'cui_str': 'Maxidex'}, {'cui': 'C0015399', 'cui_str': 'Ophthalmic Drops'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}]",20.0,0.260922,"There were no statistically significant differences between the groups in absolute (p = 0.36) or relative (p = 1.0) success rates, number of medications (p = 0.71) or reoperations (p = 1.0) between the groups at any time-point.
","[{'ForeName': 'Gauti', 'Initials': 'G', 'LastName': 'Jóhannesson', 'Affiliation': 'Department of Clinical Sciences, Ophthalmology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'María Soffía', 'Initials': 'MS', 'LastName': 'Gottfredsdóttir', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, National University Hospital, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Guðrún Marta', 'Initials': 'GM', 'LastName': 'Ásgrimsdóttir', 'Affiliation': 'Oculis ehf., Reykjavik, Iceland.'}, {'ForeName': 'Thorsteinn', 'Initials': 'T', 'LastName': 'Loftsson', 'Affiliation': 'Oculis ehf., Reykjavik, Iceland.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Stefánsson', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, National University Hospital, University of Iceland, Reykjavik, Iceland.'}]",Acta ophthalmologica,['10.1111/aos.14370']
1015,32430334,Polygenic risk for skin autoimmunity impacts immune checkpoint blockade in bladder cancer.,"PD-1 and PD-L1 act to restrict T cell responses in cancer and contribute to self-tolerance. Consistent with this role, PD-1 checkpoint inhibitors have been associated with immune-related adverse events (irAEs), immune toxicities thought to be autoimmune in origin. Analyses of dermatological irAEs have identified an association with improved overall survival (OS) following anti-PD-(L)1 therapy, but the factors that contribute to this relationship are poorly understood. We collected germline whole-genome sequencing data from IMvigor211, a recent phase 3 randomized controlled trial comparing atezolizumab (anti-PD-L1) monotherapy to chemotherapy in bladder cancer. We found that high vitiligo, high psoriasis, and low atopic dermatitis polygenic risk scores (PRSs) were associated with longer OS under anti-PD-L1 monotherapy as compared to chemotherapy, reflecting the Th17 polarization of these diseases. PRSs were not correlated with tumor mutation burden, PD-L1 immunohistochemistry, nor T-effector gene signatures. Shared genetic factors impact risk for dermatological autoimmunity and anti-PD-L1 monotherapy in bladder cancer.",2020,"PRSs were not correlated with tumor mutation burden, PD-L1 immunohistochemistry, nor T-effector gene signatures.",['bladder cancer'],['atezolizumab (anti-PD-L1) monotherapy'],"['overall survival (OS', 'low atopic dermatitis polygenic risk scores (PRSs']","[{'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0526833,"PRSs were not correlated with tumor mutation burden, PD-L1 immunohistochemistry, nor T-effector gene signatures.","[{'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Khan', 'Affiliation': 'Genentech, South San Francisco, CA 94080; khanz12@gene.com iram@gene.com albertm@insitro.com.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Di Nucci', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Kwan', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hammer', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Mariathasan', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Rouilly', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carroll', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Fontes', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Ley Acosta', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Guardino', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Haiyin', 'Initials': 'H', 'LastName': 'Chen-Harris', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Bhangale', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Mellman', 'Affiliation': 'Genentech, South San Francisco, CA 94080; khanz12@gene.com iram@gene.com albertm@insitro.com.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'Genitourinary Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY 10065.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Experimental Cancer Medicine Centre, Barts Cancer Institute, Queen Mary University of London, EC1M 6BQ London, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Hunkapiller', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'G Scott', 'Initials': 'GS', 'LastName': 'Chandler', 'Affiliation': 'Genentech, South San Francisco, CA 94080.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Albert', 'Affiliation': 'Genentech, South San Francisco, CA 94080; khanz12@gene.com iram@gene.com albertm@insitro.com.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1922867117']
1016,19138933,Aberrant crypt foci in the adenoma prevention with celecoxib trial.,"Aberrant crypt foci (ACF) are the earliest visible neoplastic lesions in the colorectum. The natural history of these lesions and their role in the adenoma-carcinoma sequence are unknown. We studied ACF in a subset of patients randomized to placebo (n = 17), celecoxib (200 mg twice daily; n = 15), or celecoxib (400 mg twice daily; n = 13) in the Adenoma Prevention with Celecoxib (APC) trial. Magnification chromoendoscopy was done to identify, count, and biopsy ACF within the rectum at baseline and after 8 to 12 months of treatment. A total of 655 ACF were identified in 45 patients. We examined 70 of these ACF histologically, and all 70 were nondysplastic. Cohort characteristics and APC trial treatment results for substudy patients were similar to those of the overall APC trial. There was no significant modulation of ACF by celecoxib (versus placebo; P = 0.77). Immunohistochemical comparison of ACF with adjacent normal mucosa showed that ACF had an increased proliferative index as determined by Ki-67 (P < 0.0001), but lacked other features of neoplasia such as increased cyclooxygenase-2 expression and microvessel density, nuclear localization of beta-catenin, or decreased expression of the tumor suppressors SMAD4, Estrogen Receptor alpha, or MGMT. Only baseline SMAD4 expression in ACF correlated with posttreatment adenoma recurrence (independent of treatment arm; P = 0.01). The presence or number of nondysplastic ACF did not correlate with a higher risk of synchronous advanced or recurrent adenomas. Our overall results indicated that nondysplastic ACF were not accurate surrogate endpoint biomarkers of recurrent colorectal adenomas in the APC trial.",2008,The presence or number of nondysplastic ACF did not correlate with a higher risk of synchronous advanced or recurrent adenomas.,[],"['Celecoxib', 'placebo', 'celecoxib ', 'ACF', 'nondysplastic ACF', 'celecoxib']","['proliferative index', 'ACF', 'Aberrant crypt foci', 'cyclooxygenase-2 expression and microvessel density, nuclear localization of beta-catenin, or decreased expression of the tumor suppressors SMAD4, Estrogen Receptor alpha, or MGMT', 'Aberrant crypt foci (ACF']",[],"[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1171800', 'cui_str': '(18F)ACF'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1171800', 'cui_str': '(18F)ACF'}, {'cui': 'C1879526', 'cui_str': 'Aberrant Crypt Foci'}, {'cui': 'C0387583', 'cui_str': 'COX-2 Prostaglandin Synthase'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C2350570', 'cui_str': 'Microvessels'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C0105770'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0665341', 'cui_str': 'Estrogen Receptor alpha'}]",655.0,0.177643,The presence or number of nondysplastic ACF did not correlate with a higher risk of synchronous advanced or recurrent adenomas.,"[{'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Cho', 'Affiliation': ""Department of Surgery, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Redston', 'Affiliation': ''}, {'ForeName': 'Ann G', 'Initials': 'AG', 'LastName': 'Zauber', 'Affiliation': ''}, {'ForeName': 'Adelaide M', 'Initials': 'AM', 'LastName': 'Carothers', 'Affiliation': ''}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Hornick', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilton', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sontag', 'Affiliation': ''}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Nishioka', 'Affiliation': ''}, {'ForeName': 'Francis M', 'Initials': 'FM', 'LastName': 'Giardiello', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Saltzman', 'Affiliation': ''}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gostout', 'Affiliation': ''}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Eagle', 'Affiliation': ''}, {'ForeName': 'Ernest T', 'Initials': 'ET', 'LastName': 'Hawk', 'Affiliation': ''}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'Bertagnolli', 'Affiliation': ''}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-07-0011']
1017,32430890,Living Arrangements and Supplemental Income Programs for Older Adults in Mexico.,"Living arrangements often reflect important quality-of-life indicators for elderly adults. In particular, increased income can prompt changes in household living arrangements for elderly adults. Using a differences-in-differences approach, we examine whether a supplemental income program in Mexico for adults aged 70 and older influenced household size and composition. We compare outcomes at baseline and at six-month follow-up for elderly adults in the treatment group with those in the control group that did not participate in the program. We find that household size increased by 3% in the treatment group relative to the control group. We also find a statistically significant increase in the number of girls aged 6-11 in the household, likely the granddaughters or great-granddaughters of program recipients. Increases in household size were greatest for adults aged 70-79, couples, households receiving two or more supplemental incomes, and households in the top income tercile. Household size did not increase for households of adults aged 80 and older, singles, households with only one supplemental income recipient, and households not in the top income tercile. These results suggest that when older adults have more income, they use part of this income to house their grandchildren.",2020,"Household size did not increase for households of adults aged 80 and older, singles, households with only one supplemental income recipient, and households not in the top income tercile.","['adults aged 70-79, couples, households receiving two or more supplemental incomes, and households in the top income tercile', 'Older Adults in Mexico', 'elderly adults in the treatment group with those in the control group that did not participate in the program', 'adults aged 70 and older influenced household size and composition', 'elderly adults']",['supplemental income program'],['household size'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]","[{'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.0386983,"Household size did not increase for households of adults aged 80 and older, singles, households with only one supplemental income recipient, and households not in the top income tercile.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Aguila', 'Affiliation': 'Sol Price School of Public Policy, University of Southern California, 650 Childs Way, Los Angeles, CA, 90089, USA. eaguilav@usc.edu.'}, {'ForeName': 'Jung Ho', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Sol Price School of Public Policy, University of Southern California, 650 Childs Way, Los Angeles, CA, 90089, USA.'}, {'ForeName': 'Alma', 'Initials': 'A', 'LastName': 'Vega', 'Affiliation': 'Kaiser Permanente, 393 East Walnut St., Pasadena, CA, 91108, USA.'}]",Demography,['10.1007/s13524-020-00879-3']
1018,19540477,"Intercourse compliance, ovulation, and treatment success in the National Institute of Child Health and Human Development-Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome (PPCOS) Trial.","OBJECTIVE


To investigate the relationship among intercourse compliance, ovulation, and the occurrence of pregnancy in the Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome (RMNPPCOS) Trial.
DESIGN


Post hoc data analysis of subjects in the Reproductive Medicine Network PPCOS Trial.
SETTING


Academic medical centers.
INTERVENTION(S)


None.
PATIENT(S)


Six hundred twenty-six infertile women with polycystic ovary syndrome with a mean age of 28.1+/-4 years and mean body mass index of 35.2+/-8.7 kg/m2.
MAIN OUTCOME MEASURE(S)


Intercourse compliance, ovulation, and pregnancy.
RESULT(S)


Data on 2925 cycles were included in the analysis, of which 1340 were ovulatory cycles and 1585 were nonovulatory cycles. The rates of intercourse compliance in the PPCOS trial were similar across all treatment groups at all cycles except cycle 4. Among cycles with known ovulation status, 81.2% of patients were compliant with intercourse instructions. Patients were more intercourse compliant in those cycles during which ovulation occurred (83.2% vs. 79.4%). With regard to ovulatory cycles, there was no difference in the occurrence of pregnancy when comparing intercourse compliant versus intercourse noncompliant cycles.
CONCLUSION(S)


Intercourse compliance was not associated with the occurrence of pregnancy in ovulatory cycles in the PPCOS Trial. The occurrence of ovulation still remains a critical predictor for the occurrence of pregnancy.",2010,"With regard to ovulatory cycles, there was no difference in the occurrence of pregnancy when comparing intercourse compliant versus intercourse noncompliant cycles.
","['Polycystic Ovary Syndrome (RMNPPCOS) Trial', 'subjects in the Reproductive Medicine Network PPCOS Trial', '2925 cycles were included in the analysis, of which 1340 were ovulatory cycles and 1585 were nonovulatory cycles', 'Academic medical centers', '\n\n\nSix hundred twenty-six infertile women with polycystic ovary syndrome with a mean age of 28.1+/-4 years and mean body mass index of 35.2+/-8.7 kg/m2']",[],"['Intercourse compliance', 'rates of intercourse compliance', 'Intercourse compliance, ovulation, and pregnancy', 'Intercourse compliance, ovulation, and treatment success', 'occurrence of pregnancy']","[{'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C0242668', 'cui_str': 'Reproductive Medicine'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory (finding)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]",[],"[{'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",626.0,0.13944,"With regard to ovulatory cycles, there was no difference in the occurrence of pregnancy when comparing intercourse compliant versus intercourse noncompliant cycles.
","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Pagidas', 'Affiliation': 'Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Providence, Rhode Island. Electronic address: kpagidas@wihri.org.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Carson', 'Affiliation': 'Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'McGovern', 'Affiliation': ""Department of Obstetrics, Gynecology and Women's Health, University of Medicine and Dentistry, New Jersey-New Jersey Medical School, Newark, New Jersey.""}, {'ForeName': 'Huiman X', 'Initials': 'HX', 'LastName': 'Barnhart', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Evan R', 'Initials': 'ER', 'LastName': 'Myers', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina; Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, Pennsylvania.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Carr', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Schlaff', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Steinkampf', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Cataldo', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Nestler', 'Affiliation': 'Department of Medicine, Virginia Commonwealth University School of Medicine.'}, {'ForeName': 'Gabey', 'Initials': 'G', 'LastName': 'Gosman', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Giudice', 'Affiliation': 'Reproductive Sciences Branch, National Institute of Child Health and Human Development, Bethesda, Maryland, and Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, California.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Fertility and sterility,['10.1016/j.fertnstert.2009.05.047']
1019,31455824,"Morphine compared to placebo for procedural pain in preterm infants: safety, efficacy and equipoise.",,2019,,['preterm infants'],"['placebo', 'Morphine']",[],"[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",[],,0.11121,,"[{'ForeName': 'Omri David', 'Initials': 'OD', 'LastName': 'Soffer', 'Affiliation': ""Division of Newborn Medicine, Boston Children's Hospital, Boston, MA, USA. Omri.soffer@childrens.harvard.edu.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cornelissen', 'Affiliation': ""Division of Pain Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Cummings', 'Affiliation': ""Division of Newborn Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Berde', 'Affiliation': ""Division of Pain Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0476-9']
1020,31955271,"Evaluation of adhesion of Streptococcus mutans, plaque accumulation on zirconia and stainless steel crowns, and surrounding gingival inflammation in primary molars: randomized controlled trial.","OBJECTIVE


To evaluate the adhesion of Streptococcus mutans to preformed zirconia and stainless steel crowns and compare plaque accumulation and gingival inflammation over a period of 1 year.
MATERIALS AND METHODS


Thirty children between 6 to 9 years with pulpectomised bilateral mandibular primary second molars were randomly divided into zirconia/stainless steel groups. Plaque was collected from the crowns using swabs at 3, 6, 9, and 12 months. Gingival and plaque index were recorded at all follow-ups. S. mutans was cultured on tryptone-yeast-cysteine-sucrose-bacitracin agar, and organisms were expressed as colony-forming units. Within-group analysis was performed using repeated measures ANOVA and between-groups using the independent T test.
RESULTS


S. mutans were found in significantly higher numbers on the stainless steel crowns as compared with zirconia crowns at all the follow-ups. Gingival inflammation and plaque index scores were also significantly higher around the stainless steel crowns as compared with zirconia at the end of 12 months follow-up.
CONCLUSION


Adhesion of S. mutans to stainless steel crowns was significantly greater when compared with zirconia, and minimal gingival inflammation and plaque accumulation was found in the tooth restored with zirconia crowns as compared with stainless steel crowns.
CLINICAL RELEVANCE


Preformed zirconia crowns prevents adhesion of S. mutans onto its surface, and reduces plaque accumulation around the crown, inflammation of surrounding gingiva compared to conventional stainless-steel crowns. Pediatric zirconia crowns could help in reducing the overall microbial density and prevalence in the oral cavity, thus reducing the caries risk in the long term.",2020,"Gingival inflammation and plaque index scores were also significantly higher around the stainless steel crowns as compared with zirconia at the end of 12 months follow-up.
","['zirconia and stainless steel crowns, and surrounding gingival inflammation in primary molars', 'Thirty children between 6 to 9\xa0years with pulpectomised bilateral mandibular primary second molars']","['zirconia and stainless steel crowns', 'zirconia/stainless steel groups']","['Gingival inflammation and plaque index scores', 'caries risk', 'Gingival and plaque index', 'plaque accumulation and gingival inflammation', 'minimal gingival inflammation and plaque accumulation', 'overall microbial density and prevalence']","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0038126', 'cui_str': 'Stainless Steel'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0078814', 'cui_str': 'zirconium oxide'}, {'cui': 'C0038126', 'cui_str': 'Stainless Steel'}, {'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0333519', 'cui_str': 'Caries (morphologic abnormality)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",30.0,0.04469,"Gingival inflammation and plaque index scores were also significantly higher around the stainless steel crowns as compared with zirconia at the end of 12 months follow-up.
","[{'ForeName': 'Mebin George', 'Initials': 'MG', 'LastName': 'Mathew', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences, Chennai, 600077, India. mebingmathew@gmail.com.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Samuel', 'Affiliation': 'Department of Public Health Dentistry, Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences, Chennai, 600077, India.'}, {'ForeName': 'Ashu Jagdish', 'Initials': 'AJ', 'LastName': 'Soni', 'Affiliation': ""Dr. Ashu's Dental Clinic, Vadodara, 390024, India.""}, {'ForeName': 'Korishettar Basavaraj', 'Initials': 'KB', 'LastName': 'Roopa', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, College of Dental Sciences, Davangere, 577004, India.'}]",Clinical oral investigations,['10.1007/s00784-020-03204-9']
1021,18503589,"Eculizumab, a terminal complement inhibitor, improves anaemia in patients with paroxysmal nocturnal haemoglobinuria.","In paroxysmal nocturnal haemoglobinuria (PNH), chronic destruction of PNH red blood cells (RBCs) by complement leads to anaemia and other serious morbidities. Eculizumab inhibits terminal complement-mediated PNH RBC destruction by targeting C5. In the phase III, double-blind, placebo-controlled, TRIUMPH study, eculizumab reduced haemolysis, stabilized haemoglobin levels, reduced transfusion requirements and improved fatigue in patients with PNH. Herein, we explored the effects of eculizumab on measures of anaemia in patients from the TRIUMPH study and the open-label SHEPHERD study, a more heterogeneous population. Eculizumab reduced haemolysis regardless of pretreatment transfusion requirements and regardless of whether or not patients became transfusion-dependent during treatment (P < 0.001). Reduction in haemolysis was associated with increased PNH RBC counts (P < 0.001) while reticulocyte counts remained elevated. Eculizumab-treated patients demonstrated significantly higher levels of haemoglobin as compared with placebo in TRIUMPH and relative to baseline levels in SHEPHERD (P < 0.001 for each study). Eculizumab lowered transfusion requirement across multiple pretreatment transfusion strata and eliminated transfusion support in a majority of both TRIUMPH and SHEPHERD patients (P < 0.001). Patients who required some transfusion support during treatment with eculizumab showed a reduction in haemolysis and transfusion requirements and an improvement in fatigue. Eculizumab reduces haemolysis and improves anaemia and fatigue, regardless of transfusion requirements.",2008,Patients who required some transfusion support during treatment with eculizumab showed a reduction in haemolysis and transfusion requirements and an improvement in fatigue.,"['patients from the TRIUMPH study and the open-label SHEPHERD study, a more heterogeneous population', 'patients with PNH', 'patients with paroxysmal nocturnal haemoglobinuria']","['Eculizumab', 'eculizumab', 'placebo']","['haemolysis and transfusion requirements', 'fatigue', 'reticulocyte counts', 'haemolysis, stabilized haemoglobin levels, reduced transfusion requirements and improved fatigue', 'anaemia and fatigue, regardless of transfusion requirements', 'levels of haemoglobin', 'Reduction in haemolysis', 'PNH RBC counts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3643615', 'cui_str': 'Triumph'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0554210', 'cui_str': 'Shepherd (occupation)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0024790', 'cui_str': 'Marchiafava-Micheli Syndrome'}]","[{'cui': 'C1541483', 'cui_str': 'eculizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2937287', 'cui_str': 'Hemolysis (observable entity)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0206161', 'cui_str': 'Reticulocyte Number'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0024790', 'cui_str': 'Marchiafava-Micheli Syndrome'}, {'cui': 'C0014772', 'cui_str': 'Erythrocyte Number'}]",,0.0604168,Patients who required some transfusion support during treatment with eculizumab showed a reduction in haemolysis and transfusion requirements and an improvement in fatigue.,"[{'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Schubert', 'Affiliation': 'Internal Medicine I, Saarland University Medical School, Homburg Saar, Germany. injsch@uks.eu'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ''}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Röth', 'Affiliation': ''}, {'ForeName': 'Neal S', 'Initials': 'NS', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Modupe O', 'Initials': 'MO', 'LastName': 'Elebute', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Szer', 'Affiliation': ''}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Gianfaldoni', 'Affiliation': ''}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Socié', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Browne', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Geller', 'Affiliation': ''}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Rother', 'Affiliation': ''}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Muus', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of haematology,['10.1111/j.1365-2141.2008.07183.x']
1022,18511076,"Changes in BDNF serum levels in patients with major depression disorder (MDD) after 6 months treatment with sertraline, escitalopram, or venlafaxine.","Recent studies have implicated brain-derived neurotrophic factor (BDNF) in the pathophysiology of depression and the activity of antidepressant drugs. Serum BDNF levels are lower in depressed patients, and increase in response to antidepressant medication. However, how BDNF responds to different classes of antidepressant drugs is unknown. We assessed serum BDNF levels in 21 patients with major depressive episode treated with sertraline, escitalopram, or venlafaxine and 20 healthy controls. Serum samples were collected between 10 a.m. and 12 p.m. at baseline, 5 weeks, and 6 months of treatment. BDNF levels were measured via immunoassay. The severity of symptoms and response to treatment were assessed by the Hamilton rating scales for depression (HRSD). Baseline serum BDNF levels were significantly lower in depressed patients compared to controls. Sertraline increased BDNF levels after 5 weeks and 6 months of treatment. Venlafaxine increased BDNF levels only after 6 months. Escitalopram did not affect BDNF levels at either time point. A significant negative association was found between percentage increase in BDNF levels and percentage decreased in HRSD scores after 6 months of treatment. In conclusion, these results suggest that different antidepressant drugs have variable effects on serum BDNF levels. This is true even though the three different drugs were equally effective in relieving symptoms of depression and anxiety.",2009,A significant negative association was found between percentage increase in BDNF levels and percentage decreased in HRSD scores after 6 months of treatment.,"['patients with major depression disorder (MDD', 'and 20 healthy controls', '21 patients with major depressive episode treated with']","['Sertraline', 'Venlafaxine', 'sertraline, escitalopram, or venlafaxine']","['HRSD scores', 'serum BDNF levels', 'Serum BDNF levels', 'Serum samples', 'Hamilton rating scales for depression (HRSD', 'Baseline serum BDNF levels', 'BDNF levels', 'BDNF serum levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}]",21.0,0.0157912,A significant negative association was found between percentage increase in BDNF levels and percentage decreased in HRSD scores after 6 months of treatment.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Matrisciano', 'Affiliation': 'Department of Psychiatry and Psychological Medicine, University of Rome ""La Sapienza"" ""Sant\'Andrea"" Hospital, Via di Grottarossa, 1035/1039, 00189 Rome, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Bonaccorso', 'Affiliation': ''}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Ricciardi', 'Affiliation': ''}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Scaccianoce', 'Affiliation': ''}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Panaccione', 'Affiliation': ''}, {'ForeName': 'Lily', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Amedo', 'Initials': 'A', 'LastName': 'Ruberto', 'Affiliation': ''}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Tatarelli', 'Affiliation': ''}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Nicoletti', 'Affiliation': ''}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Girardi', 'Affiliation': ''}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': ''}]",Journal of psychiatric research,['10.1016/j.jpsychires.2008.03.014']
1023,31518174,Adding Ovarian Suppression to Tamoxifen for Premenopausal Breast Cancer: A Randomized Phase III Trial.,"PURPOSE


The addition of ovarian function suppression (OFS) for 5 years to tamoxifen (TAM) for treatment of premenopausal patients with breast cancer after completion of chemotherapy has beneficial effects on disease-free survival (DFS). This study evaluated the efficacy of adding 2 years of OFS to TAM in patients with hormone receptor-positive breast cancer who remain in a premenopausal state or resume ovarian function after chemotherapy.
PATIENTS AND METHODS


We enrolled 1,483 premenopausal women (age ≤ 45 years) with estrogen receptor-positive breast cancer treated with definitive surgery after completing adjuvant or neoadjuvant chemotherapy. Ovarian function was assessed every 6 months for 2 years since enrollment on the basis of follicular-stimulating hormone levels and vaginal bleeding history. If ovarian function was confirmed to be premenopausal at each visit, the patient was randomly assigned to complete 5 years of TAM alone (TAM-only) group or 5 years of TAM with OFS for 2 years that involved monthly goserelin administration (TAM + OFS) group. DFS was defined from the time of enrollment to the time of the first event.
RESULTS


A total of 1,293 patients were randomly assigned, and 1,282 patients were eligible for analysis. The estimated 5-year DFS rate was 91.1% in the TAM + OFS group and 87.5% in the TAM-only group (hazard ratio, 0.69; 95% CI, 0.48 to 0.97;  P  = .033). The estimated 5-year overall survival rate was 99.4% in the TAM + OFS group and 97.8% in the TAM-only group (hazard ratio, 0.31; 95% CI, 0.10 to 0.94;  P  = .029).
CONCLUSION


The addition of 2 years of OFS to TAM significantly improved DFS compared with TAM alone in patients who remained premenopausal or resumed ovarian function after chemotherapy.",2020,"The estimated 5-year DFS rate was 91.1% in the TAM + OFS group and 87.5% in the TAM-only group (hazard ratio, 0.69; 95% CI, 0.48 to 0.97;  P  = .033).","['Premenopausal Breast Cancer', 'patients with hormone receptor-positive breast cancer who remain in a premenopausal state or resume ovarian function after chemotherapy', 'patients who remained premenopausal or resumed ovarian function after chemotherapy', 'We enrolled 1,483 premenopausal women (age ≤ 45 years) with estrogen receptor-positive breast cancer treated with definitive surgery after completing adjuvant or neoadjuvant chemotherapy', '1,293 patients were randomly assigned, and 1,282 patients were eligible for analysis', 'premenopausal patients with breast cancer after completion of']","['ovarian function suppression (OFS', 'TAM alone (TAM-only) group or 5 years of TAM with OFS for 2 years that involved monthly goserelin administration (TAM + OFS', 'TAM + OFS', 'OFS to TAM', 'chemotherapy', 'TAM', 'Tamoxifen', 'tamoxifen (TAM']","['disease-free survival (DFS', '5-year DFS rate', '5-year overall survival rate', 'DFS', 'Ovarian function']","[{'cui': 'C0741682', 'cui_str': 'Premenopausal breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2938924', 'cui_str': 'Oestrogen receptor positive breast cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0016712', 'cui_str': ""Freund's Adjuvant""}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0031843', 'cui_str': 'function'}]",1293.0,0.181147,"The estimated 5-year DFS rate was 91.1% in the TAM + OFS group and 87.5% in the TAM-only group (hazard ratio, 0.69; 95% CI, 0.48 to 0.97;  P  = .033).","[{'ForeName': 'Hyun-Ah', 'Initials': 'HA', 'LastName': 'Kim', 'Affiliation': 'Korea Cancer Center Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jong Won', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Seok Jin', 'Initials': 'SJ', 'LastName': 'Nam', 'Affiliation': 'Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Byeong-Woo', 'Initials': 'BW', 'LastName': 'Park', 'Affiliation': 'Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital Seoul, Republic of Korea.'}, {'ForeName': 'Eun Sook', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Yong Sik', 'Initials': 'YS', 'LastName': 'Jung', 'Affiliation': 'Ajou University, Suwon, Republic of Korea.'}, {'ForeName': 'Jung Han', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Chonnam National University Hwasun Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Sung Soo', 'Initials': 'SS', 'LastName': 'Kang', 'Affiliation': ""Cheil General Hospital and Women's Healthcare Center, Seoul, Republic of Korea.""}, {'ForeName': 'Soo-Jung', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Yeungnam University Hospital, Daegu, Republic of Korea.'}, {'ForeName': 'Kyong Hwa', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Korea University Anam Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Joon', 'Initials': 'J', 'LastName': 'Jeong', 'Affiliation': 'Gangnam Severance Hospital, Seoul, Republic or Korea.'}, {'ForeName': 'Se-Heon', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Dong-A University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Sung Yong', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Soonchunhyang University College of Medicine, Cheonan, Republic of Korea.'}, {'ForeName': 'Lee Su', 'Initials': 'LS', 'LastName': 'Kim', 'Affiliation': 'Hallym University Sacred Heart Hospital, Anyang, Republic of Korea.'}, {'ForeName': 'Byung-In', 'Initials': 'BI', 'LastName': 'Moon', 'Affiliation': ""Ewha Woman's University Mokdong Hospital, Seoul, Republic of Korea.""}, {'ForeName': 'Min Hyuk', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Soonchunhyang University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Tae Hyun', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Inje University Busan Paik Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Chanheun', 'Initials': 'C', 'LastName': 'Park', 'Affiliation': 'Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sung Hoo', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Chonbuk National University Medical School, Jeonju, Republic of Korea.'}, {'ForeName': 'Geumhee', 'Initials': 'G', 'LastName': 'Gwak', 'Affiliation': 'Inje University Sanggye Paik Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jeryong', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Chungnam National University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Sun Hee', 'Initials': 'SH', 'LastName': 'Kang', 'Affiliation': 'Keimyung University School of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Young Woo', 'Initials': 'YW', 'LastName': 'Jin', 'Affiliation': 'Korea Institute of Radiological and Medical Sciences, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Se-Hwan', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Ajou University, Suwon, Republic of Korea.'}, {'ForeName': 'Wonshik', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Min Hee', 'Initials': 'MH', 'LastName': 'Hur', 'Affiliation': 'Inha University, Incheon, Republic of Korea.'}, {'ForeName': 'Woo Chul', 'Initials': 'WC', 'LastName': 'Noh', 'Affiliation': 'Korea Cancer Center Hospital, Seoul, Republic of Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00126']
1024,19061201,Quantifying the recruitment challenges with couple-based interventions for cancer: applications to early-stage breast cancer.,"OBJECTIVE


Despite mounting evidence supporting the use of psychosocial interventions to promote adaptation to cancer, enrolling participants into these interventions is challenging. This is particularly salient for couple-based interventions, and newer, more targeted recruitment strategies to increase enrollment are needed. However, there have been few published empirical studies focused specifically on recruitment-related variables associated with enrollment into these types of interventions. To better understand how to encourage participation in couple-based psychosocial interventions for cancer, we examined facilitating and impeding factors to enrollment into a couple-based intervention for women with early-stage breast cancer.
METHOD


In this sample of 99 women diagnosed with early-stage breast cancer, patient demographic variables and method of approaching eligible patients were examined as predictors of enrollment into a randomized controlled trial comparing couple-based relationship enhancement with treatment as usual.
RESULTS


Results indicated that women were more likely to enroll if they were contacted at home or at a follow-up medical appointment rather than when first diagnosed at a busy multidisciplinary clinic; they were also more likely to enroll the closer they lived to the research facility.
CONCLUSIONS


In addition to decreasing participant burden, timing and setting of recruitment efforts may have important implications for enhancing participation rates in couple-based intervention studies for cancer.",2009,"RESULTS


Results indicated that women were more likely to enroll if they were contacted at home or at a follow-up medical appointment rather than when first diagnosed at a busy multidisciplinary clinic; they were also more likely to enroll the closer they lived to the research facility.
","['99 women diagnosed with early-stage breast cancer, patient demographic variables and method of approaching eligible patients', 'women with early-stage breast cancer']",['psychosocial interventions'],[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]",[],[],99.0,0.0450854,"RESULTS


Results indicated that women were more likely to enroll if they were contacted at home or at a follow-up medical appointment rather than when first diagnosed at a busy multidisciplinary clinic; they were also more likely to enroll the closer they lived to the research facility.
","[{'ForeName': 'Steffany J', 'Initials': 'SJ', 'LastName': 'Fredman', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. fredman@bu.edu'}, {'ForeName': 'Donald H', 'Initials': 'DH', 'LastName': 'Baucom', 'Affiliation': ''}, {'ForeName': 'Tina M', 'Initials': 'TM', 'LastName': 'Gremore', 'Affiliation': ''}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Castellani', 'Affiliation': ''}, {'ForeName': 'Theresa A', 'Initials': 'TA', 'LastName': 'Kallman', 'Affiliation': ''}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': ''}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Kirby', 'Affiliation': ''}, {'ForeName': 'E Claire', 'Initials': 'EC', 'LastName': 'Dees', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Klauber-Demore', 'Affiliation': ''}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Peppercorn', 'Affiliation': ''}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': ''}]",Psycho-oncology,['10.1002/pon.1477']
1025,31880965,Value of Biomarker Expression for Randomized Clinical Trial Design: One (More) Missed Opportunity.,,2020,,[],[],[],[],[],[],,0.076184,,"[{'ForeName': 'Francisco E', 'Initials': 'FE', 'LastName': 'Vera-Badillo', 'Affiliation': ""Francisco E. Vera-Badillo, MD, MSc and Andrew J. Robinson, MD, Department of Oncology, Queen's University, Kingston, Ontario, Canada; David M. Berman, MD, PhD, Department of Pathology and Molecular Medicine, Queen's University, Kingston, Ontario, Canada; and Christopher M. Booth, MD, Department of Oncology, Queen's University; and Cancer Care and Epidemiology, Queen's Research Institute, Kingston, Ontario, Canada.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Robinson', 'Affiliation': ""Francisco E. Vera-Badillo, MD, MSc and Andrew J. Robinson, MD, Department of Oncology, Queen's University, Kingston, Ontario, Canada; David M. Berman, MD, PhD, Department of Pathology and Molecular Medicine, Queen's University, Kingston, Ontario, Canada; and Christopher M. Booth, MD, Department of Oncology, Queen's University; and Cancer Care and Epidemiology, Queen's Research Institute, Kingston, Ontario, Canada.""}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Berman', 'Affiliation': ""Francisco E. Vera-Badillo, MD, MSc and Andrew J. Robinson, MD, Department of Oncology, Queen's University, Kingston, Ontario, Canada; David M. Berman, MD, PhD, Department of Pathology and Molecular Medicine, Queen's University, Kingston, Ontario, Canada; and Christopher M. Booth, MD, Department of Oncology, Queen's University; and Cancer Care and Epidemiology, Queen's Research Institute, Kingston, Ontario, Canada.""}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Booth', 'Affiliation': ""Francisco E. Vera-Badillo, MD, MSc and Andrew J. Robinson, MD, Department of Oncology, Queen's University, Kingston, Ontario, Canada; David M. Berman, MD, PhD, Department of Pathology and Molecular Medicine, Queen's University, Kingston, Ontario, Canada; and Christopher M. Booth, MD, Department of Oncology, Queen's University; and Cancer Care and Epidemiology, Queen's Research Institute, Kingston, Ontario, Canada.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02393']
1026,31981566,Change in Clinical Practice Associated With a Large Randomized Controlled Trial Comparing RBC Transfusion Strategies.,,2020,,[],[],[],[],[],[],,0.109654,,"[{'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Trentino', 'Affiliation': 'School of Population and Global Health, University of Western Australia, Perth, Australia; Data and Digital Innovation, East Metropolitan Health Service, Perth, Australia. Electronic address: kevin.trentino@uwa.edu.au.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sanfilippo', 'Affiliation': 'School of Population and Global Health, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Leahy', 'Affiliation': 'Department of Haematology, PathWest Laboratory Medicine, Royal Perth Hospital, Perth, Australia.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Farmer', 'Affiliation': 'Medical School and Division of Surgery, University of Western Australia, Perth, Australia; School of Health Sciences and Graduate Studies, Curtin University, Perth, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Gilfillan', 'Affiliation': 'Department of Cardiothoracic Surgery, Fiona Stanley Hospital, Perth, Australia.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murray', 'Affiliation': 'School of Population and Global Health, University of Western Australia, Perth, Australia.'}]",Chest,['10.1016/j.chest.2020.01.004']
1027,31651581,Neuromodulation: more than a placebo effect?,,2020,,[],[],[],[],[],[],,0.164589,,"[{'ForeName': 'Sophie W', 'Initials': 'SW', 'LastName': 'Kjær', 'Affiliation': 'Department of Psychology and Behavioural Sciences, School of Business and Social Sciences, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Andrew S C', 'Initials': 'ASC', 'LastName': 'Rice', 'Affiliation': 'Pain Research, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Wartolowska', 'Affiliation': 'Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Vase', 'Affiliation': 'Department of Psychology and Behavioural Sciences, School of Business and Social Sciences, Aarhus University, Aarhus, Denmark.'}]",Pain,['10.1097/j.pain.0000000000001727']
1028,32088427,Depressive symptom severity as a predictor of attendance in the HOME behavioral weight loss trial.,"OBJECTIVE


We examined whether total depressive symptoms and symptom clusters predicted behavioral weight loss attendance among economically disadvantaged adults in a randomized controlled trial.
METHODS


150 adults with obesity were randomized to 12 months of in-person, video conference, or enhanced usual care weight loss groups. We categorized percent session attendance in the intervention arms into three levels: no attendance, poorer attendance, and better attendance.
RESULTS


Higher baseline Patient Health Questionnaire-8 (PHQ-8) score was associated with a greater odds of being in the poorer versus better attendance group (OR = 1.94, 95% CI: 1.02-3.69, p = .04). A similar relationship between PHQ-8 score and odds of being in the no attendance versus better attendance group was observed but was not statistically significant (OR = 1.63, 95% CI: 0.94-2.81, p = .08). Both cognitive/affective and somatic clusters contributed to the depressive symptoms-attendance relationships.
CONCLUSION


Greater depressive symptoms at the start of a behavioral weight loss program may predict poorer subsequent session attendance. Screening for and addressing depression may improve intervention uptake. ClinicalTrials.gov Identifier: NCT02057952.",2020,"A similar relationship between PHQ-8 score and odds of being in the no attendance versus better attendance group was observed but was not statistically significant (OR = 1.63, 95% CI: 0.94-2.81,","['150 adults with obesity', 'economically disadvantaged adults']","['video conference, or enhanced usual care weight loss groups']","['Greater depressive symptoms', 'Depressive symptom severity', 'behavioral weight loss attendance', 'Health Questionnaire-8 (PHQ-8) score', 'PHQ-8 score and odds of being in the no attendance']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",150.0,0.19435,"A similar relationship between PHQ-8 score and odds of being in the no attendance versus better attendance group was observed but was not statistically significant (OR = 1.63, 95% CI: 0.94-2.81,","[{'ForeName': 'Aubrey L', 'Initials': 'AL', 'LastName': 'Shell', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis (IUPUI), United States of America.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Hsueh', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis (IUPUI), United States of America.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Vrany', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD, United States of America.'}, {'ForeName': 'Daniel O', 'Initials': 'DO', 'LastName': 'Clark', 'Affiliation': 'Indiana University Center for Aging Research, Indiana University School of Medicine, United States of America; Department of Kinesiology, Indiana University-Purdue University Indianapolis, United States of America.'}, {'ForeName': 'NiCole R', 'Initials': 'NR', 'LastName': 'Keith', 'Affiliation': 'Indiana University Center for Aging Research, Indiana University School of Medicine, United States of America; Department of Kinesiology, Indiana University-Purdue University Indianapolis, United States of America.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Biostatistics, Fairbanks School of Public Health, Indiana University, United States of America.'}, {'ForeName': 'Jesse C', 'Initials': 'JC', 'LastName': 'Stewart', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis (IUPUI), United States of America. Electronic address: jstew@iupui.edu.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.109970']
1029,32427723,Smartphone App and Carbon Monoxide Self-Monitoring Support for Smoking Cessation: A Randomized Controlled Trial Nested into the Swiss HIV Cohort Study.,,2020,,"['smoking cessation', 'Swiss HIV Cohort Study']",['Smartphone app and carbon monoxide self-monitoring support'],[],"[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",[],,0.0705271,,"[{'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Gryaznov', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Chammartin', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Stoeckle', 'Affiliation': 'Division of Infectious Diseases and Hospital Hygiene University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Anagnostopoulos', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Dominique Laurent', 'Initials': 'DL', 'LastName': 'Braun', 'Affiliation': 'Division of Infectious Diseases and Hospital Epidemiology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Hansjakob', 'Initials': 'H', 'LastName': 'Furrer', 'Affiliation': 'Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Noémie', 'Initials': 'N', 'LastName': 'Boillat-Blanco', 'Affiliation': 'Infectious Diseases Service, University Hospital of Lausanne, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'Enos', 'Initials': 'E', 'LastName': 'Bernasconi', 'Affiliation': 'Division of Infectious Diseases, Ospedale Regionale di Lugano-Civico e Italiano, Lugano, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schmid', 'Affiliation': 'Division of Infectious Diseases and Hospital Hygiene, Kantonsspital St. Gallen, St.Gallen, Switzerland.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Nordmann', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Heiner C', 'Initials': 'HC', 'LastName': 'Bucher', 'Affiliation': 'Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, University of Basel, Basel, Switzerland.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002396']
1030,18675521,Facial emotion recognition and amygdala activation are associated with menstrual cycle phase.,"Converging evidence has accumulated that menstrual cycle and thus hormonal levels can affect emotional behavior, in particular facial emotion recognition. Here we explored the association of ovarian hormone levels and amygdala activation during an explicit emotion recognition task in two groups of healthy young females: one group was measured while in their follicular phase (n=11) and the other during their luteal phase (n=11). Using a 3T scanner in combination with a protocol specifically optimized to reliably detect amygdala activation we found significantly stronger amygdala activation in females during their follicular phase. Also, emotion recognition performance was significantly better in the follicular phase. We observed significant negative correlations between progesterone levels and amygdala response to fearful, sad and neutral faces, further supporting a significant modulation of behavior and neural response by hormonal changes during the menstrual cycle. From an evolutionary point of view this significant influence of ovarian hormone level on emotion processing and an important neural correlate, the amygdala, may enable a higher social sensitivity in females during their follicular phase, thus facilitating socio-emotional behavior (and social interaction) which may possibly facilitate mating behavior as well.",2008,Using a 3T scanner in combination with a protocol specifically optimized to reliably detect amygdala activation we found significantly stronger amygdala activation in females during their follicular phase.,['two groups of healthy young females'],[],"['Facial emotion recognition and amygdala activation', 'emotion recognition performance', 'progesterone levels and amygdala response to fearful, sad and neutral faces']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}]",,0.014617,Using a 3T scanner in combination with a protocol specifically optimized to reliably detect amygdala activation we found significantly stronger amygdala activation in females during their follicular phase.,"[{'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Derntl', 'Affiliation': 'MR Centre of Excellence, Medical University of Vienna, Vienna, Austria. bderntl@ukaachen.de'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Windischberger', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Robinson', 'Affiliation': ''}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lamplmayr', 'Affiliation': ''}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Kryspin-Exner', 'Affiliation': ''}, {'ForeName': 'Ruben C', 'Initials': 'RC', 'LastName': 'Gur', 'Affiliation': ''}, {'ForeName': 'Ewald', 'Initials': 'E', 'LastName': 'Moser', 'Affiliation': ''}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Habel', 'Affiliation': ''}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2008.04.014']
1031,32017597,Pulse Wave Velocity in Chronic Obstructive Pulmonary Disease and the Impact of Inhaled Therapy (SUMMIT): A Randomized Double-Blind Clinical Trial.,,2020,,[],['Inhaled Therapy (SUMMIT'],[],[],"[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.735713,,"[{'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Crim', 'Affiliation': 'GlaxoSmithKline plcResearch Triangle Park, North Carolina.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Anderson', 'Affiliation': 'GlaxoSmithKline plcMiddlesex, United Kingdom.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'University Hospital AintreeLiverpool, United Kingdom.'}, {'ForeName': 'Bartolome R', 'Initials': 'BR', 'LastName': 'Celli', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical SchoolBoston, Massachusetts.""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Cowans', 'Affiliation': 'Veramed Ltd.Twickenham, United Kingdom.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Weill Cornell MedicineNew York, New York.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'University of EdinburghEdinburgh, United Kingdom.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': 'The University of Manchester Manchester, United Kingdom.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Yates', 'Affiliation': 'GlaxoSmithKline plcResearch Triangle Park, North Carolina.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': 'University of MichiganAnn Arbor, Michigan.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201908-1639LE']
1032,17917553,"Evidence for the efficacy of duloxetine in treating mild, moderate, and severe depression.","Clinicians need to know whether duloxetine is effective in patients across a broad range of depressive symptoms and depression severity. Data were pooled from nine randomized, double-blind, placebo-controlled studies in major depressive disorder (total N=2227) comparing duloxetine (40-120 mg/day) with placebo for 8-9 weeks. Patients were retrospectively stratified by baseline score on the HAMD17 into mild (< or =19; n=682), moderate (n=1099), or severe (> or =25; n=446) groups. Duloxetine produced significantly greater baseline-to-endpoint mean change than placebo in HAMD17 total score, Maier and retardation subscales, and the Clinical Global Impressions-Severity of Illness scale in all three cohorts. Significant improvement was seen in HAMD17 items 1 (depressed mood), 3 (suicide), 7 (work and activities), and 10 (psychic anxiety) regardless of severity. The HAMD17 anxiety subscale and items 13 (somatic symptoms-general) and 15 (hypochondriasis) showed significant improvement only in moderately and severely ill patients. Significant improvement in the HAMD17 Maier subscale was seen in all groups by week 1. In all three groups, placebo was significantly superior to duloxetine at early visits on HAMD17 item 12 (somatic symptoms-GI). Mildly and severely ill patients exhibited significant reduction in visual analog scale overall pain severity at the study endpoint. The studies contained fewer patients with very mild or very severe illness, limiting our ability to draw conclusions in these patient populations. Duloxetine demonstrated superior efficacy in the treatment of major depressive disorder, when compared with placebo, regardless of the baseline severity of depressive symptoms, although effect sizes were largest in the most severely depressed patients.",2007,"In all three groups, placebo was significantly superior to duloxetine at early visits on HAMD17 item 12 (somatic symptoms-GI).","['Patients were retrospectively stratified by baseline score on the HAMD17 into mild (< or =19; n=682), moderate (n=1099), or severe (> or =25; n=446) groups']","['Duloxetine', 'placebo', 'duloxetine']","['HAMD17 anxiety subscale', 'visual analog scale overall pain severity', 'HAMD17 Maier subscale', 'HAMD17 total score, Maier and retardation subscales, and the Clinical Global Impressions-Severity of Illness scale', 'HAMD17 items 1 (depressed mood), 3 (suicide), 7 (work and activities), and 10 (psychic anxiety) regardless of severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",2227.0,0.222894,"In all three groups, placebo was significantly superior to duloxetine at early visits on HAMD17 item 12 (somatic symptoms-GI).","[{'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry, Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Andorn', 'Affiliation': ''}, {'ForeName': 'Craig H', 'Initials': 'CH', 'LastName': 'Mallinckrodt', 'Affiliation': ''}, {'ForeName': 'Madelaine M', 'Initials': 'MM', 'LastName': 'Wohlreich', 'Affiliation': ''}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Raskin', 'Affiliation': ''}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Watkin', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Detke', 'Affiliation': ''}]",International clinical psychopharmacology,[]
1033,32428718,Prospective Randomized Study on the Effects of Improved Sleep Quality After Craniotomy on Melatonin Concentrations and Inflammatory Response in Neurosurgical Intensive Care Patients.,"OBJECTIVE


Sleep disorders in intensive care units after a craniotomy can decrease melatonin secretion and increase the inflammatory stress response. The aim of this study was to investigate the influence of improving sleep quality via eye patches and earplugs on melatonin secretion and inflammatory mediator release.
METHODS


The study enrolled 41 patients who underwent craniotomy. Patients were randomized into 2 groups. ""Group Intervention"" received a sleep-promoting intervention with eye patches and earplugs to provide light and noise isolation, while ""Group Control"" received standard care. Blood levels of C-reactive protein and interleukin 1 and interleukin 6 along with urine levels of 6-sulphatoxymelatonin (aMT6) were measured preoperatively (baseline) and on postoperative days 1 and 3. Sleep quality was assessed with the Richards-Campbell Sleep Questionnaire.
RESULTS


Sleep quality was higher in the intervention group (Richards-Campbell score:80.61 ± 11.96 vs. 33.50 ± 16.32; P < 0.001). Urine aMT6 levels increased significantly in the intervention group in spot urine samples from 10.15 (5.38-14.40) ng/mL at baseline to 14.52 (6.24-29.11) and 11.51 (7.88-29.05) ng/mL on postoperative days 1 and 3. They also increased in 24-hour urine samples from 25.73 (8.24-52.73) ng/mL at baseline to 35.38 (11.48-95.65) and 39.18 (2.36-125.23) ng/mL on postoperative days 1 and 3 (P = 0.001 and P = 0.005, respectively). The aMT6 concentration did not change significantly in the control group. The C-reactive protein concentrations increased postoperatively compared with baseline concentrations in both groups (P = 0.001 and P < 0.001).
CONCLUSIONS


Melatonin secretion significantly increased as a result of improving postoperative sleep quality by noise and light isolation in neurosurgical intensive care unit patients after craniotomy.",2020,"The CRP concentrations increased postoperatively compared to baseline concentrations in both groups (p=0.001 and p<0.001).
","['neurosurgical ICU patients after craniotomy', 'neurosurgical intensive-care patients 2 ', '41 patients who underwent craniotomy']","['sleep-promoting intervention with eye patches and earplugs to provide light and noise isolation, while Group Control received standard care']","['levels', 'Blood levels of C reactive protein (CRP) and interleukin 1(IL-1) and 6 (IL-6) along with urine levels of 6-sulphatoxymelatonin (aMT6', '24-hour urine samples', 'aMT6 concentration', 'Urine aMT6', 'Sleep quality', 'postoperative sleep quality', 'CRP concentrations', 'melatonin secretion', 'sleep quality', 'inflammatory stress response']","[{'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0776981', 'cui_str': 'Eye patch'}, {'cui': 'C1135964', 'cui_str': 'Ear plug'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0049713', 'cui_str': '6-sulfatoxymelatonin'}, {'cui': 'C0456209', 'cui_str': '24 hour urine sample'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",41.0,0.140342,"The CRP concentrations increased postoperatively compared to baseline concentrations in both groups (p=0.001 and p<0.001).
","[{'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Arık', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey. Electronic address: emineincearik@yahoo.com.'}, {'ForeName': 'Habibullah', 'Initials': 'H', 'LastName': 'Dolgun', 'Affiliation': 'Department of Neurosurgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Sahin', 'Initials': 'S', 'LastName': 'Hanalioglu', 'Affiliation': 'Department of Neurosurgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Omer Selcuk', 'Initials': 'OS', 'LastName': 'Sahin', 'Affiliation': 'Department of Neurosurgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Ucar', 'Affiliation': 'Department of Clinical Biochemistry, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Dilek', 'Initials': 'D', 'LastName': 'Yazicioglu', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ihsan', 'Initials': 'I', 'LastName': 'Dogan', 'Affiliation': 'Department of Neurosurgery, Ankara University, İbn-i Sina Hospital, Ankara, Turkey.'}, {'ForeName': 'Erdal Resit', 'Initials': 'ER', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Neurosurgery, University of Health Science, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}]",World neurosurgery,['10.1016/j.wneu.2020.05.017']
1034,31507250,Using the Personalized Advantage Index for individual treatment allocation to cognitive behavioral therapy (CBT) or a CBT with integrated exposure and emotion-focused elements (CBT-EE).,"Even though different psychotherapeutic interventions for depression have shown to be effective, patients suffering from depression vary substantially in their treatment response. The goal of this study was to answer the following research questions: (1) What are the most important predictors determining optimal treatment allocation to cognitive behavioral therapy (CBT) or CBT with integrated exposure and emotion-focused elements (CBT-EE)?, and (2) Would model-determined treatment allocation using this predictive information result in better treatment outcomes? Bayesian Model Averaging (BMA) was applied to the data of a randomized controlled trial comparing the efficacy of CBT and CBT-EE in depressive outpatients. Predictions were made for every patient for both treatment conditions and an optimal versus a suboptimal treatment was identified in each case. An index comparing the two estimates, the Personalized Advantage Index (PAI), was calculated. Different predictors were found for both conditions. A PAI of 1.35 BDI-II points for the two conditions was found and 46% of the sample was predicted to have a clinically meaningful advantage in one of the therapies. Although the utility of the PAI approach must be further confirmed in prospective research, the present study study promotes the identification of specific interventions favorable for specific patients.",2020,Different predictors were found for both conditions.,['depressive outpatients'],"['cognitive behavioral therapy (CBT', 'CBT and CBT-EE', 'Bayesian Model Averaging (BMA', 'cognitive behavioral therapy (CBT) or CBT with integrated exposure and emotion-focused elements (CBT-EE']",['Personalized Advantage Index (PAI'],"[{'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0013879', 'cui_str': 'Elements'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0178449,Different predictors were found for both conditions.,"[{'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Friedl', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Switzerland.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Krieger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Switzerland.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Caspar', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Grosse Holtforth', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Switzerland.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2019.1664782']
1035,30979659,"Dietary walnut altered gene expressions related to tumor growth, survival, and metastasis in breast cancer patients: a pilot clinical trial.","Consumption of walnuts has slowed breast cancer growth and/or reduced the risk of mammary cancer in mice. The benefit against cancer was associated with altered expression of genes for cancer growth and survival. We hypothesized that walnut consumption would alter gene expression in pathologically confirmed breast cancers of women in a direction that would be expected to decrease breast cancer growth and survival, as was seen in mice. The study was a nonplacebo, 2-arm, clinical trial. Women with breast lumps large enough for research and pathology biopsies were recruited and randomized to walnut consuming or control groups. Immediately after biopsy collection, women in the walnut group began to consume 2 oz of walnuts per day until follow-up surgery. Pathological studies confirmed that lumps were breast cancer in all women who remained in the trial. At surgery, about 2 weeks after biopsy, additional specimens were taken from the breast cancers. Changes in gene expression in the surgical specimen compared to baseline were determined in each individual woman in walnut-consuming (n = 5) and control (n = 5) groups. RNA sequencing expression profiling revealed that expression of 456 identified genes was significantly changed in the tumor due to walnut consumption. Ingenuity Pathway Analysis showed activation of pathways that promote apoptosis and cell adhesion, and inhibition of pathways that promote cell proliferation and migration. These results support the hypothesis that, in humans, walnut consumption could suppress growth and survival of breast cancers.",2019,RNA sequencing expression profiling revealed that expression of 456 identified genes was significantly changed in the tumor due to walnut consumption.,"['breast cancer patients', 'Women with breast lumps large enough for research and pathology biopsies']",[],"['growth and survival of breast cancers', 'altered expression of genes for cancer growth and survival', 'breast cancer growth and survival', 'tumor growth, survival, and metastasis']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0024103', 'cui_str': 'Breast lump (finding)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",[],"[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.0352901,RNA sequencing expression profiling revealed that expression of 456 identified genes was significantly changed in the tumor due to walnut consumption.,"[{'ForeName': 'W Elaine', 'Initials': 'WE', 'LastName': 'Hardman', 'Affiliation': 'Joan C. Edwards School of Medicine, Marshall University, Department of Biomedical Sciences, 1600 Medical Center Dr, Huntington, WV 25701, USA. Electronic address: hardmanw@marshall.edu.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Primerano', 'Affiliation': 'Joan C. Edwards School of Medicine, Marshall University, Department of Biomedical Sciences, 1600 Medical Center Dr, Huntington, WV 25701, USA. Electronic address: primeran@marshall.edu.'}, {'ForeName': 'Mary T', 'Initials': 'MT', 'LastName': 'Legenza', 'Affiliation': 'Edwards Comprehensive Cancer Center, 1400 Hal Greer Dr, Huntington, WV 25701, USA. Electronic address: legenza@marshall.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Morgan', 'Affiliation': ""St. Mary's Cancer Center, 2900 1st Ave, Huntington, WV 25702, USA. Electronic address: jhmorgan3@gmail.com.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': 'Joan C. Edwards School of Medicine, Marshall University, Department of Biomedical Sciences, 1600 Medical Center Dr, Huntington, WV 25701, USA. Electronic address: fanj@marshall.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Denvir', 'Affiliation': 'Joan C. Edwards School of Medicine, Marshall University, Department of Biomedical Sciences, 1600 Medical Center Dr, Huntington, WV 25701, USA. Electronic address: denvir@marshall.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2019.03.004']
1036,32428586,"Integrating an online weight management program with population health management in primary care: Design, methods, and baseline data from the PROPS randomized controlled trial (Partnerships for Reducing Overweight and Obesity with Patient-centered Strategies).","BACKGROUND


Scalable, low-cost weight management strategies are needed in primary care. We conducted a pragmatic, cluster-randomized controlled trial to examine the effectiveness of an online weight management program integrated with population health management support.
METHODS


We adapted an online weight management program and integrated it with population health management support in 15 primary care practices (24 clinics). We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI). Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI) ≥ 27 and < 40 kg/m 2 , and a diagnosis of hypertension or type 2 diabetes. Participants attended routine visits and completed surveys over 18 months. The primary outcome is absolute weight change at 12 months (± 90 days) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record.
RESULTS


We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI.) At enrollment, participants' mean age was 59.3 years, their mean weight was 203.1 pounds, and their mean BMI was 32.5 kg/m 2 ; 60% of participants were female, 76.8% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes.
CONCLUSION


It is feasible to adapt an online weight management program and integrate it with population health management support in primary care. The results of this trial will provide valuable information about the effectiveness of these strategies in primary care settings. ClinicalTrials.govregistration number:NCT02656693.",2020,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","['Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI)\u202f≥\u202f27 and\u202f<\u202f40\u202fkg/m 2 , and a diagnosis of hypertension or type 2 diabetes', '15 primary care practices (24 clinics', ""At enrollment, participants' mean age was 59.3\u202fyears, their mean weight was 203.1 pounds, and their mean BMI was 32.5\u202fkg/m 2 ; 60% of participants were female, 76% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes"", 'We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI']","['online weight management program with population health management', 'online weight management program and integrated it with population health management support', 'usual care (UC), online program alone (OP), or combined intervention (CI', 'online weight management program integrated with population health management support']","['absolute weight change at 12\u202fmonths (± 90\u202fdays) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C4704688', 'cui_str': 'Population Health Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}]",840.0,0.0950447,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","[{'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Baer', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America. Electronic address: hbaer@bwh.harvard.edu.""}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'De La Cruz', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Rozenblum', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Nyryan V', 'Initials': 'NV', 'LastName': 'Nolido', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Metzler', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Block', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Department of Population Medicine, Harvard Pilgrim Healthcare Institute, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Florencia', 'Initials': 'F', 'LastName': 'Halperin', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'McManus', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Aronne', 'Affiliation': 'BMIQ Professionals Program, Intellihealth/BMIQ, United States of America; Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York, NY, United States of America.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Minero', 'Affiliation': 'BMIQ Professionals Program, Intellihealth/BMIQ, United States of America.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Bates', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106026']
1037,32434686,Corrigendum to 'Efficacy and safety of food fortification to improve Vitamin D intakes of older adults' [Nutrition 75-76 (2020)].,,2020,,"[""older adults' [Nutrition 75-76 (2020""]",['food fortification'],['Vitamin D intakes'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C0564439', 'cui_str': 'Vitamin D intake'}]",,0.01844,,"[{'ForeName': 'Aislinn', 'Initials': 'A', 'LastName': 'McCourt', 'Affiliation': 'UCD Institute of Food and Health, University College Dublin, Belfield, Dublin 4, Ireland.'}, {'ForeName': 'Breige A', 'Initials': 'BA', 'LastName': 'McNulty', 'Affiliation': 'UCD Institute of Food and Health, University College Dublin, Belfield, Dublin 4, Ireland.'}, {'ForeName': 'Janette', 'Initials': 'J', 'LastName': 'Walton', 'Affiliation': 'School of Biological Sciences, Cork Institute of Technology, Cork, Ireland.'}, {'ForeName': 'Aifric', 'Initials': 'A', 'LastName': ""O'Sullivan"", 'Affiliation': 'UCD Institute of Food and Health, University College Dublin, Belfield, Dublin 4, Ireland. Electronic address: Aifric.osullivan@ucd.ie.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110837']
1038,31499457,Age differences in electrocortical reactivity to fearful faces following aversive conditioning in youth.,"Although biases in the processing of affectively salient stimuli are thought to increase risk for psychopathology across the lifespan, questions remain regarding how these biases develop. The current study tested an aversive conditioning model for the development of children's sensitivity in detecting fearful faces at varying levels of emotional intensity and their facilitated attention to fearful faces assessed via the late positive potential (LPP) event-related potential component. Participants (N = 144, ages 7-11 years) were randomly assigned to one of three conditions: an active training condition in which an 85-dB white noise burst was paired with fearful faces, an active control condition in which the white noise was presented randomly throughout the task, and a no-sound condition. Children completed a separate task in which they viewed happy, sad, and fearful child faces at varying levels of emotional intensity while electroencephalography (EEG) was recorded. Although there were no conditioning group differences in children's sensitivity in detecting facial displays of emotion, there were group differences in LPP magnitude that were moderated by children's age. Among younger children, those in the active conditioning group exhibited smaller LPP amplitudes to high-intensity fearful faces than children in the control groups. However, among older youth, those in the active conditioning group exhibited larger LPP amplitudes to high-intensity fearful faces than children in the control groups. These findings provide insight into how attentional biases may develop in children and how period of development may influence these patterns.",2019,"Although there were no conditioning group differences in children's sensitivity in detecting facial displays of emotion, there were group differences in LPP magnitude that were moderated by children's age.","['youth', 'younger children', 'Participants (N\u202f=\u202f144, ages 7-11\u202fyears']","['active training condition in which an 85-dB white noise burst was paired with fearful faces, an active control condition in which the white noise was presented randomly throughout the task, and a no-sound condition']","['smaller LPP amplitudes', 'LPP amplitudes', 'LPP magnitude']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}]",,0.0533471,"Although there were no conditioning group differences in children's sensitivity in detecting facial displays of emotion, there were group differences in LPP magnitude that were moderated by children's age.","[{'ForeName': 'Katie L', 'Initials': 'KL', 'LastName': 'Burkhouse', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL 60608, USA. Electronic address: kburkho@uic.edu.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Owens', 'Affiliation': 'Department of Psychology, University of South Florida St. Petersburg, St. Petersburg, FL 33701, USA.'}, {'ForeName': 'Kiera', 'Initials': 'K', 'LastName': 'James', 'Affiliation': 'Department of Psychology, Binghamton University (State University of New York), Binghamton, NY 13902, USA.'}, {'ForeName': 'Brandon E', 'Initials': 'BE', 'LastName': 'Gibb', 'Affiliation': 'Department of Psychology, Binghamton University (State University of New York), Binghamton, NY 13902, USA.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.104676']
1039,31229396,Building Blocks for Healthy Children: Evaluation of a Child Care Center-Based Obesity Prevention Pilot Among Low-Income Children.,"OBJECTIVE


To assess the impact of a multilevel nutrition intervention for low-income child care environments, staff, and center-enrolled children.
DESIGN


A cluster-randomized, controlled trial conducted among eligible centers. Staff and parent self-report surveys and objective field observations at baseline and follow-up were conducted.
SETTING


A total of 22 low-income child care centers (enrolling ≥ 25 2- to 5-year-old children).
PARTICIPANTS


Children aged 18-71 months; 408 children and 97 staff were randomized into intervention (208 children and 50 staff) and waitlist-control groups (200 children and 45 staff). Retention rates were high (87% for children and 93% for staff).
INTERVENTION(S)


A 6-session, 6-month director's child nutrition course with on-site technical support for center teachers.
MAIN OUTCOME MEASURE(S)


Center nutrition/physical activity environment; staff feeding styles, dietary patterns, and attitudes about food; child food preferences and dietary patterns.
ANALYSIS


Covariance regression analyses to assess the intervention effect, adjusting for clustering within centers.
RESULTS


Significant intervention effects were found for the center nutrition training/education environment (b = 3.01; P = .03), nutrition total scores (b = 1.29; P = .04), and staff-level prompting/encouraging feeding styles (b = 0.38; P = .04). No significant intervention effects were found for child-level measures.
CONCLUSIONS AND IMPLICATIONS


Curriculum-driven training and implementation support improved nutritional policies and practices and staff-child interactions during meals. Future research could extend the intervention to families and the evaluation to children's dietary behaviors and weight changes.",2019,"RESULTS


Significant intervention effects were found for the center nutrition training/education environment (b = 3.01; P = .03), nutrition total scores (b = 1.29; P = .04), and staff-level prompting/encouraging feeding styles (b = 0.38; P = .04). ","['Healthy Children', 'A total of 22 low-income child care centers', 'Children aged 18-71 months; 408 children and 97 staff were randomized into intervention (208 children and 50 staff) and waitlist-control groups (200 children and 45 staff', 'enrolling ≥ 25 2- to 5-year-old children', 'low-income child care environments, staff, and center-enrolled children', 'eligible centers', 'Low-Income Children']","['Child Care Center-Based Obesity Prevention Pilot', 'multilevel nutrition intervention']","['staff-level prompting/encouraging\xa0feeding styles', 'Retention rates', 'center nutrition training/education environment', 'nutrition total scores', 'child-level measures']","[{'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517769', 'cui_str': 'Four hundred and eight'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0008078', 'cui_str': 'Childrens Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",408.0,0.0522384,"RESULTS


Significant intervention effects were found for the center nutrition training/education environment (b = 3.01; P = .03), nutrition total scores (b = 1.29; P = .04), and staff-level prompting/encouraging feeding styles (b = 0.38; P = .04). ","[{'ForeName': 'Brittany R', 'Initials': 'BR', 'LastName': 'Schuler', 'Affiliation': 'School of Social Work, College of Public Health, Temple University, Philadelphia, PA. Electronic address: brittany.schuler@temple.edu.'}, {'ForeName': 'Baylie', 'Initials': 'B', 'LastName': 'Fowler', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Rubio', 'Affiliation': 'University of Minnesota Medical School, Twin Cities Campus, Twin Cities, MN.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kilby', 'Affiliation': 'Maryland State Department of Education, Baltimore, MD.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Hager', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Black', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD; Distinguished Fellow, RTI International, Research Triangle Park, NC.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2019.04.017']
1040,31392840,"Pharmacokinetics and Pharmacodynamics of Insulin Tregopil in Relation to Premeal Dosing Time, Between Meal Interval, and Meal Composition in Patients With Type 2 Diabetes Mellitus.","We evaluated the pharmacokinetics and pharmacodynamics of oral insulin tregopil in relation to premeal dosing time, between-meal interval, and meal composition type in type 2 diabetes mellitus patients in a randomized, placebo-controlled, crossover study consisting of 3 sequential cohorts. In Cohort 1, insulin tregopil administered 10 to 20 minutes before a meal resulted in optimal postmeal exposure and demonstrated better postprandial glucose-lowering effect (glucose area under concentration-time curve [AUC]) compared to the 30-minute group. In Cohort 2, insulin tregopil pharmacokinetic exposure (plasma AUC) showed a progressive increase through 4, 5, and 6 hours of between-meal interval. The 6-hour between-meal interval resulted in better absorption of insulin tregopil in comparison to 4- and 5-hour intervals. However, no significant differences were observed in pharmacodynamic parameters except for higher glucose AUC 0-180min  in the insulin tregopil 4-hour group during the afternoon meal as compared to the morning meal. In Cohort 3, a high-fiber meal had the least impact on insulin tregopil absorption and resulted in the highest reduction in plasma glucose levels in the afternoon. A high-fat meal reduced insulin tregopil absorption in the afternoon meal; however, pharmacodynamic response was not diminished significantly. Insulin tregopil has a rapid onset of action of approximately 10 minutes and, when administered 10 to 20 minutes before a meal, demonstrated up to 13% to 18% reduction in blood glucose levels compared to baseline. A 5-hour between-meal interval minimizes the impact of a meal on absorption of subsequent (afternoon) insulin tregopil dose, and the pharmacodynamic response of insulin tregopil is not altered by meal composition. Insulin tregopil was well tolerated in patients with type 2 diabetes mellitus.",2020,"However, no significant differences were observed in pharmacodynamic parameters except for higher glucose AUC 0-180min  in the insulin tregopil 4-hour group during the afternoon meal as compared to the morning meal.","['patients with type 2 diabetes mellitus', 'Patients', 'type 2 diabetes mellitus patients']","['oral insulin tregopil', 'Insulin tregopil', 'placebo']","['absorption of insulin tregopil', 'insulin tregopil pharmacokinetic exposure (plasma AUC', 'postprandial glucose-lowering effect (glucose area under concentration-time curve [AUC', 'insulin tregopil absorption', 'plasma glucose levels', 'pharmacodynamic response', 'blood glucose levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}]",,0.0249698,"However, no significant differences were observed in pharmacodynamic parameters except for higher glucose AUC 0-180min  in the insulin tregopil 4-hour group during the afternoon meal as compared to the morning meal.","[{'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Khedkar', 'Affiliation': 'Employed at Biocon Research Ltd., during study conduct, Bengaluru, Karnataka, India.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Lebovitz', 'Affiliation': 'State University of New York Health Science Centre at Brooklyn, Brooklyn, NY, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fleming', 'Affiliation': 'Kinexum, Harpers Ferry, WV, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cherrington', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Vinu', 'Initials': 'V', 'LastName': 'Jose', 'Affiliation': 'Employed at Biocon Research Ltd., during study conduct, Bengaluru, Karnataka, India.'}, {'ForeName': 'Sandeep N', 'Initials': 'SN', 'LastName': 'Athalye', 'Affiliation': 'Biocon Research Ltd., Bengaluru, Karnataka, India.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Vishweswaramurthy', 'Affiliation': 'Biocon Research Ltd., Bengaluru, Karnataka, India.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.730']
1041,32073152,Can We Uncouple Neighborhood Disadvantage and Delinquent Behaviors? An Experimental Test of Family Resilience Guided by the Social Disorganization Theory of Delinquent Behaviors.,"Although the influence of neighborhood disadvantage on youth development of delinquent behavior is well established, findings from this research have yet to inform the development of family-centered prevention programming to protect youth from these erosive effects. The current paper examines the role of family integration in buffering the impact of social disadvantage in a sample of N = 298 families randomly assigned either to a control condition or to a family-based prevention program previously shown to enhance marriage and parenting. We first confirmed that neighborhood concentrated disadvantage predicted change in delinquent behaviors across the course of the study. Additionally, replicating prior work, parents participating in the Protecting Strong African American Families (ProSAAF) program, relative to those randomly assigned to the control group, significantly improved their use of effective communication strategies with each other and reduced ineffective conflict in front of youth. This resulted in a significant indirect effect of ProSAAF on change in youth delinquent behaviors. Furthermore, using mediated moderation analysis, the study tested the buffering effect of greater family integration, showing that experimentally produced change in interparental communication skills and the resulting reduction in youth exposure to parental conflict buffered the effect of neighborhood disadvantage on change in youth delinquent behaviors, supporting a mediated moderation model in which family environments buffer neighborhood effects.",2020,The current paper examines the role of family integration in buffering the impact of social disadvantage in a sample of N = 298 families randomly assigned either to a control condition or to a family-based prevention program previously shown to enhance marriage and parenting.,['youth delinquent behaviors'],"['control condition or to a family-based prevention program', 'ProSAAF']",['delinquent behaviors'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0522174', 'cui_str': 'Delinquent behavior (finding)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0522174', 'cui_str': 'Delinquent behavior (finding)'}]",298.0,0.0220154,The current paper examines the role of family integration in buffering the impact of social disadvantage in a sample of N = 298 families randomly assigned either to a control condition or to a family-based prevention program previously shown to enhance marriage and parenting.,"[{'ForeName': 'Man-Kit', 'Initials': 'MK', 'LastName': 'Lei', 'Affiliation': 'Department of Sociology, University of Georgia, Athens, GA.'}, {'ForeName': 'Steven R H', 'Initials': 'SRH', 'LastName': 'Beach', 'Affiliation': 'Department of Psychology, University of Georgia, Athens, GA.'}]",Family process,['10.1111/famp.12527']
1042,32045087,Experience-based co-design-Adapting the method for a researcher-initiated study in a multi-site setting.,"BACKGROUND


Experience-based co-design (EBCD) brings patients and staff together to co-design services. It is normally conducted in one organization which initiates and implements the process. We used the traditional EBCD method with a number of adaptations as part of a larger research study in the British National Health Service.
METHODS


The primary aim was to assess the feasibility and acceptability of conducting research-initiated EBCD, to enhance intervention development prior to testing. As well as embedding the method in a research study, there were 3 further key adaptations: (a) working across primary and secondary care sectors, (b) working on multiple sites and (c) incorporating theory-informed analysis.
RESULTS


We recruited four sites (covering both primary and secondary care) and, on each site, conducted the initial traditional EBCD meetings, with separate staff and patient groups-followed by a single joint patient-staff event, where four priority areas for co-design were agreed. This event was driven by theory-informed analysis, as well as the traditional trigger film of patient experiences. Each site worked on one priority area, and the four co-design groups met over 2-3 months to design prototype tools. A second joint event was held (not usually undertaken in single-site EBCD) where they shared and compared outputs. The research team combined elements of these outputs to create an intervention, now being tested in a cluster randomized controlled trial.
CONCLUSIONS


EBCD can be successfully adapted for use across an entire patient pathway with multiple organizations and as part of a research process to identify an intervention for subsequent testing in a randomized trial. Our pragmatic approach used the patient experience to identify areas for improvement and co-designed an intervention which directly reflected patient priorities.",2020,Our pragmatic approach used the patient experience to identify areas for improvement and co-designed an intervention which directly reflected patient priorities.,[],[],['feasibility and acceptability'],[],[],"[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.026757,Our pragmatic approach used the patient experience to identify areas for improvement and co-designed an intervention which directly reflected patient priorities.,"[{'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Raynor', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Hanif', 'Initials': 'H', 'LastName': 'Ismail', 'Affiliation': 'University of Bradford, Bradford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Blenkinsopp', 'Affiliation': 'University of Bradford, Bradford, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Fylan', 'Affiliation': 'University of Bradford, Bradford, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Armitage', 'Affiliation': 'University of Bradford, Bradford, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Silcock', 'Affiliation': 'University of Bradford, Bradford, UK.'}]",Health expectations : an international journal of public participation in health care and health policy,['10.1111/hex.13028']
1043,32041644,Anabolic response to essential amino acid plus whey protein composition is greater than whey protein alone in young healthy adults.,"BACKGROUND


We have determined the acute response of protein kinetics to one or two servings (6.3 g and 12.6 g) of a proprietary composition containing free-form essential amino acids (EAA) (3.2 g EAA per serving) and whey protein (2.4 g per serving), as well as the response to consumption of a popular whey-based protein supplement (Gatorade Recover) (17 g; 12.6 g protein).
METHODS


Whole-body rates of protein synthesis, breakdown and net balance (taken to be the anabolic response) were determined using primed-constant infusions of  2 H 5 -phenylalnine and  2 H 2 -tyrosine. Muscle protein fractional synthetic rate (FSR) was also determined with the  2 H 5 -phenylalanine tracer.
RESULTS


Plasma EAA levels increased following consumption of all beverages, with the greatest response in the high-dose EAA/protein composition. Similarly, the increase in net balance between whole-body protein synthesis and breakdown was greatest following consumption of the high-dose EAA/protein composition, while the low-dose EAA/protein composition and Gatorade Recover induced similar increases in net balance. When the net balance response was normalized for the total amount of product given, the high- and low-dose EAA/protein beverages were approximately 6- and 3-fold more anabolic than the Gatorade Recover, respectively. The greater anabolic response to the EAA/protein composition was due to greater increases in whole-body protein synthesis with both doses, and a markedly greater suppression of whole-body protein breakdown in the high-dose group. Muscle protein FSR after beverage consumption reflected changes in whole-body protein synthesis, with the larger EAA/protein dose significantly increasing FSR.
CONCLUSION


We conclude that a composition of a balanced EAA formulation combined with whey protein is highly anabolic as compared to a whey protein-based recovery product, and that the response is dose-dependent.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03502941. This trial was registered on April 19, 2018.",2020,"RESULTS


Plasma EAA levels increased following consumption of all beverages, with the greatest response in the high-dose EAA/protein composition.",['young healthy adults'],[],"['anabolic response', 'Plasma EAA levels', 'net balance', 'protein synthesis, breakdown and net balance', 'Muscle protein fractional synthetic rate (FSR']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]",[],"[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0026832', 'cui_str': 'Muscle Proteins'}]",,0.016109,"RESULTS


Plasma EAA levels increased following consumption of all beverages, with the greatest response in the high-dose EAA/protein composition.","[{'ForeName': 'Sanghee', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, Center for Translational Research in Aging & Longevity, University of Arkansas for Medical Sciences, 4301 West Markham Street, Slot 806, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Church', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, Center for Translational Research in Aging & Longevity, University of Arkansas for Medical Sciences, 4301 West Markham Street, Slot 806, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'Gohar', 'Initials': 'G', 'LastName': 'Azhar', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, University of Arkansas for Medical Sciences, 4301 W Markham Street, Slot 748, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Schutzler', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, Center for Translational Research in Aging & Longevity, University of Arkansas for Medical Sciences, 4301 West Markham Street, Slot 806, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'Arny A', 'Initials': 'AA', 'LastName': 'Ferrando', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, Center for Translational Research in Aging & Longevity, University of Arkansas for Medical Sciences, 4301 West Markham Street, Slot 806, Little Rock, AR, 72205-7199, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Wolfe', 'Affiliation': 'Department of Geriatrics, Donald W. Reynolds Institute on Aging, Center for Translational Research in Aging & Longevity, University of Arkansas for Medical Sciences, 4301 West Markham Street, Slot 806, Little Rock, AR, 72205-7199, USA. rwolfe2@uams.edu.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-0340-5']
1044,32077305,Join the Commune: A Controlled Study of Social Branding Influencers to Decrease Smoking Among Young Adult Hipsters.,"PURPOSE


To evaluate the impact of a Social Branding intervention in bars and nightclubs on smoking behavior.
DESIGN


Quasi-experimental controlled study.
SETTING


Bars and nightclubs in San Diego and San Francisco (intervention) and Los Angeles (control).
PARTICIPANTS


""Hipster"" young adults (age 18-26) attending bars and nightclubs.
INTERVENTION


Anti-tobacco messages delivered through monthly anti-tobacco music/social events, opinion leaders, original art, direct mail, promotional activities, and online media.
MEASURES


A total of 7240 surveys were collected in 3 cities using randomized time location sampling at baseline (2012-2013) and follow-up (2015-2016); data were analyzed in 2018. The primary outcome was current smoking.
ANALYSIS


Multivariable logistic regression assessed correlates of smoking, adjusting for covariates including electronic cigarette use; differences between cities were evaluated using location-by-time interactions.
RESULTS


Smoking in San Francisco decreased at a significantly faster rate (51.1%-44.1%) than Los Angeles (45.2%-44.5%) ( P  = .034). Smoking in San Diego (mean: 39.6%) was significantly lower than Los Angeles (44.8%,  P  < .001) at both time points with no difference in rate of change. Brand recall was not associated with smoking behavior, but recall was associated with anti-tobacco attitudes that were associated with smoking.
CONCLUSION


This is the first controlled study of Social Branding interventions. Intervention implementation was accompanied by decreases in smoking (San Francisco) and sustained lower smoking (San Diego) among young adult bar patrons over 3 years.",2020,Intervention implementation was accompanied by decreases in smoking (San Francisco) and sustained lower smoking (San Diego) among young adult bar patrons over 3 years.,"['Young Adult Hipsters', 'Hipster"" young adults (age 18-26) attending bars and nightclubs', 'A total of 7240 surveys were collected in 3 cities using randomized time location sampling at baseline (2012-2013) and follow-up (2015-2016); data were analyzed in 2018', 'Join the Commune', 'Bars and nightclubs in San Diego and San Francisco (intervention) and Los Angeles (control']","['Social Branding intervention', 'Anti-tobacco messages delivered through monthly anti-tobacco music/social events, opinion leaders, original art, direct mail, promotional activities, and online media']","['smoking (San Francisco) and sustained lower smoking (San Diego', 'faster rate', 'current smoking', 'Smoking in San Francisco']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0442567', 'cui_str': 'Nightclub (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0871010', 'cui_str': 'Opinions'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]",7240.0,0.0214507,Intervention implementation was accompanied by decreases in smoking (San Francisco) and sustained lower smoking (San Diego) among young adult bar patrons over 3 years.,"[{'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Ling', 'Affiliation': 'Division of General Internal Medicine and Center for Tobacco Control Research and Education, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Nadra E', 'Initials': 'NE', 'LastName': 'Lisha', 'Affiliation': 'Division of General Internal Medicine and Center for Tobacco Control Research and Education, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Center for AIDS Prevention Studies, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Jordan', 'Affiliation': 'Rescue Agency, San Diego, CA, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120904917']
1045,17307935,Anxiety sensitivity as a prospective predictor of alcohol use disorders.,"Emerging evidence suggests that elevated anxiety sensitivity (AS) is associated with substance use disorders. However, prospective evidence regarding this association is currently lacking. The primary aim of the present study was to determine whether AS is involved in the pathogenesis of substance-related psychopathology. A large, nonclinical sample of young adults (N = 404) was prospectively followed for approximately 2 years. AS (i.e., 16-item Anxiety Sensitivity Index total scores) at study entry and gender served as the primary predictor variables. Findings indicated that AS was uniquely associated with the later development of alcohol use disorder diagnoses. Data indicated that gender and AS did not act synergistically to predict alcohol use disorders. These data provide novel evidence for the unique effects of AS as a prospective risk factor in the development of alcohol-related disorders.",2007,Data indicated that gender and AS did not act synergistically to predict alcohol use disorders.,['young adults (N = 404'],[],"['Anxiety sensitivity', '16-item Anxiety Sensitivity Index total scores']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",404.0,0.0312602,Data indicated that gender and AS did not act synergistically to predict alcohol use disorders.,"[{'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Psychology, Florida State University, Tallahassee, FL 32306-1270, USA. schmidt@psy.fsu.edu'}, {'ForeName': 'Julia D', 'Initials': 'JD', 'LastName': 'Buckner', 'Affiliation': ''}, {'ForeName': 'Meghan E', 'Initials': 'ME', 'LastName': 'Keough', 'Affiliation': ''}]",Behavior modification,[]
1046,30012675,Low-Dose Anti-Thymocyte Globulin (ATG) Preserves β-Cell Function and Improves HbA 1c  in New-Onset Type 1 Diabetes.,"OBJECTIVE


A pilot study suggested that combination therapy with low-dose anti-thymocyte globulin (ATG) and pegylated granulocyte colony-stimulating factor (GCSF) preserves C-peptide in established type 1 diabetes (T1D) (duration 4 months to 2 years). We hypothesized that  1 ) low-dose ATG/GCSF or  2 ) low-dose ATG alone would slow the decline of β-cell function in patients with new-onset T1D (duration <100 days).
RESEARCH DESIGN AND METHODS


A three-arm, randomized, double-masked, placebo-controlled trial was performed by the Type 1 Diabetes TrialNet Study Group in 89 subjects: 29 subjects randomized to ATG (2.5 mg/kg intravenously) followed by pegylated GCSF (6 mg subcutaneously every 2 weeks for 6 doses), 29 to ATG alone (2.5 mg/kg), and 31 to placebo. The primary end point was mean area under the curve (AUC) C-peptide during a 2-h mixed-meal tolerance test 1 year after initiation of therapy. Significance was defined as one-sided  P  value < 0.025.
RESULTS


The 1-year mean AUC C-peptide was significantly higher in subjects treated with ATG (0.646 nmol/L) versus placebo (0.406 nmol/L) ( P  = 0.0003) but not in those treated with ATG/GCSF (0.528 nmol/L) versus placebo ( P  = 0.031). HbA 1c  was significantly reduced at 1 year in subjects treated with ATG and ATG/GCSF,  P  = 0.002 and 0.011, respectively.
CONCLUSIONS


Low-dose ATG slowed decline of C-peptide and reduced HbA 1c  in new-onset T1D. Addition of GCSF did not enhance C-peptide preservation afforded by low-dose ATG. Future studies should be considered to determine whether low-dose ATG alone or in combination with other agents may prevent or delay the onset of the disease.",2018,"HbA 1c  was significantly reduced at 1 year in subjects treated with ATG and ATG/GCSF,  P  = 0.002 and 0.011, respectively.
","['Type 1 Diabetes TrialNet Study Group in 89 subjects: 29 subjects randomized to', 'established type 1 diabetes (T1D) (duration 4 months to 2 years']","['ATG', 'placebo', 'Low-Dose Anti-Thymocyte Globulin (ATG', 'pegylated GCSF ', 'ATG/GCSF', 'combination therapy with low-dose anti-thymocyte globulin (ATG) and pegylated granulocyte colony-stimulating factor (GCSF']","['1-year mean AUC C-peptide', 'β-cell function', 'HbA 1c', 'mean area under the curve (AUC) C-peptide']","[{'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0359156', 'cui_str': 'Rabbit anti-human T-lymphocyte globulin'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",29.0,0.382567,"HbA 1c  was significantly reduced at 1 year in subjects treated with ATG and ATG/GCSF,  P  = 0.002 and 0.011, respectively.
","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Haller', 'Affiliation': ''}, {'ForeName': 'Desmond A', 'Initials': 'DA', 'LastName': 'Schatz', 'Affiliation': ''}, {'ForeName': 'Jay S', 'Initials': 'JS', 'LastName': 'Skyler', 'Affiliation': ''}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Krischer', 'Affiliation': ''}, {'ForeName': 'Brian N', 'Initials': 'BN', 'LastName': 'Bundy', 'Affiliation': ''}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Atkinson', 'Affiliation': ''}, {'ForeName': 'Dorothy J', 'Initials': 'DJ', 'LastName': 'Becker', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Baidal', 'Affiliation': ''}, {'ForeName': 'Linda A', 'Initials': 'LA', 'LastName': 'DiMeglio', 'Affiliation': ''}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Gitelman', 'Affiliation': ''}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Goland', 'Affiliation': ''}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Gottlieb', 'Affiliation': ''}, {'ForeName': 'Kevan C', 'Initials': 'KC', 'LastName': 'Herold', 'Affiliation': ''}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Marks', 'Affiliation': ''}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Moran', 'Affiliation': ''}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Rodriguez', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Russell', 'Affiliation': ''}, {'ForeName': 'Darrell M', 'Initials': 'DM', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Carla J', 'Initials': 'CJ', 'LastName': 'Greenbaum', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc18-0494']
1047,32040960,"Poxvirus Vectored Cytomegalovirus Vaccine to Prevent Cytomegalovirus Viremia in Transplant Recipients: A Phase 2, Randomized Clinical Trial.","Background


Triplex vaccine was developed to enhance cytomegalovirus (CMV)-specific T cells and prevent CMV reactivation early after hematopoietic stem cell transplant (HCT).
Objective


To determine the safety and efficacy of Triplex.
Design


First-in-patient, phase 2 trial. (ClinicalTrials.gov: NCT02506933).
Setting


3 U.S. HCT centers.
Participants


102 CMV-seropositive HCT recipients at high risk for CMV reactivation.
Intervention


Intramuscular injections of Triplex or placebo were given on days 28 and 56 after HCT. Triplex is a recombinant attenuated poxvirus (modified vaccinia Ankara) expressing immunodominant CMV antigens.
Measurements


The primary outcomes were CMV events (CMV DNA level ≥1250 IU/mL, CMV viremia requiring antiviral treatment, or end-organ disease), nonrelapse mortality, and severe (grade 3 or 4) graft-versus-host disease (GVHD), all evaluated through 100 days after HCT, and grade 3 or 4 adverse events (AEs) within 2 weeks after vaccination that were probably or definitely attributable to injection.
Results


A total of 102 patients (51 per group) received the first vaccination, and 91 (89.2%) received both vaccinations (46 Triplex and 45 placebo). Reactivation of CMV occurred in 5 Triplex (9.8%) and 10 placebo (19.6%) recipients (hazard ratio, 0.46 [95% CI, 0.16 to 1.4]; P = 0.075). No Triplex recipient died of nonrelapse causes during the first 100 days or had serious AEs, and no grade 3 or 4 AEs related to vaccination were observed within 2 weeks after vaccination. Incidence of severe acute GVHD after injection was similar between groups (hazard ratio, 1.1 [CI, 0.53 to 2.4]; P = 0.23). Levels of long-lasting, pp65-specific T cells with effector memory phenotype were significantly higher in Triplex than placebo recipients.
Limitation


The lower-than-expected incidence of CMV events in the placebo group reduced the power of the trial.
Conclusion


No vaccine-associated safety concerns were identified. Triplex elicited and amplified CMV-specific immune responses, and fewer Triplex-vaccinated patients had CMV viremia.
Primary Funding Source


National Cancer Institute and Helocyte.",2020,"Levels of long-lasting, pp65-specific T cells with effector memory phenotype were significantly higher in Triplex than placebo recipients.
","['≥1250', 'Participants\n\n\n102 CMV-seropositive HCT recipients at high risk for CMV reactivation', 'Transplant Recipients', '102 patients (51 per group) received the first vaccination, and 91 (89.2%) received']","['Poxvirus Vectored Cytomegalovirus Vaccine', 'placebo', 'Triplex or placebo', 'both vaccinations (46 Triplex and 45 placebo']","['Cytomegalovirus Viremia', 'CMV events (CMV DNA level', 'Incidence of severe acute GVHD', 'Levels of long-lasting, pp65-specific T cells with effector memory phenotype', 'nonrelapse mortality, and severe (grade 3 or 4) graft-versus-host disease (GVHD', 'CMV events', 'cytomegalovirus (CMV)-specific T cells and prevent CMV reactivation', 'Triplex elicited and amplified CMV-specific immune responses', 'Reactivation of CMV']","[{'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1407119', 'cui_str': 'Transplant present'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0032868', 'cui_str': 'Poxviruses'}, {'cui': 'C0887903', 'cui_str': 'Cytomegalovirus Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0877635', 'cui_str': 'Cytomegalovirus viremia'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0018133', 'cui_str': 'Homologous Wasting Disease'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C4543203', 'cui_str': 'Effector (disposition)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0010825', 'cui_str': 'Salivary Gland Viruses'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}]",102.0,0.529622,"Levels of long-lasting, pp65-specific T cells with effector memory phenotype were significantly higher in Triplex than placebo recipients.
","[{'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Aldoss', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'La Rosa', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Lindsey R', 'Initials': 'LR', 'LastName': 'Baden', 'Affiliation': ""Brigham and Women's Hospital and Dana-Farber Cancer Institute, Boston, Massachusetts (L.R.B., N.C.I.).""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Longmate', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Ella J', 'Initials': 'EJ', 'LastName': 'Ariza-Heredia', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas (E.J.A.).'}, {'ForeName': 'Wasima N', 'Initials': 'WN', 'LastName': 'Rida', 'Affiliation': 'Biostatistics Consultant, Arlington, Virginia (W.N.R.).'}, {'ForeName': 'Chetan Raj', 'Initials': 'CR', 'LastName': 'Lingaraju', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Martinez', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Kaltcheva', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Dagis', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Hardwick', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Nicolas C', 'Initials': 'NC', 'LastName': 'Issa', 'Affiliation': ""Brigham and Women's Hospital and Dana-Farber Cancer Institute, Boston, Massachusetts (L.R.B., N.C.I.).""}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Farol', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Auayporn', 'Initials': 'A', 'LastName': 'Nademanee', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Monzr M', 'Initials': 'MM', 'LastName': 'Al Malki', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Forman', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': 'Ryotaro', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'City of Hope Comprehensive Cancer Center, Duarte, California (I.A., L.F., A.N., M.M.A., R.N.).'}, {'ForeName': 'Don J', 'Initials': 'DJ', 'LastName': 'Diamond', 'Affiliation': 'City of Hope Comprehensive Cancer Center and the Beckman Research Institute of City of Hope, Duarte, California (C.L., J.L., C.R.L., Q.Z., J.M., T.K., A.D., N.H., S.F., D.J.D.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M19-2511']
1048,31906976,Carbohydrate supplementation and psychophysiological responses during moderate exercise in hypoxia.,"BACKGROUND


Rating of Perceived Exertion (RPE) is a subjective scale to monitor overload and fatigue during exercise. Hypoxia may worsen the perception of fatigue, compromising the self-reported perception of effort and increasing RPE. The objective was to evaluate the effects of carbohydrate (CHO) supplementation on RPE during exercise in hypoxia simulating 4200 m.
METHODS


Eight male physically active volunteers performed two exercises at 50% VO 2peak  and 1% slope: exercise in hypoxia + placebo or exercise in hypoxia + CHO (6% maltodextrin) with supplementation at 20, 40, and 60 min during exercise. Oxygen Saturation (SaO 2 %) was assessed at baseline and after exercise, while RPE and HR were measured each 10 min during the trial.
RESULTS


SaO 2 % decreased after exercise in both conditions of hypoxia compared to rest. The RPE did not differ between groups. However, the RPE increased in hypoxia after 20 min of exercise in relation to 10 min. The Area Under the Curve (AUC) of RPE was lower in hypoxia + CHO compared to hypoxia. The AUC of the HR/RPE ratio in the hypoxia + CHO group was higher in relation to hypoxia.
CONCLUSIONS


Our results indicate that CHO supplementation does not change RPE induced by 60 min of exercise at 50% VO 2peak  in hypoxia equivalent to 4200 m at the different times analyzed. However, in hypoxia + CHO the (AUC)-60 min of total RPE decreased during exercise, while the heart rate/RPE ratio improved, indicating lower RPE in the hypoxic environment.",2020,The RPE did not differ between groups.,"['moderate exercise in hypoxia', 'Eight male physically active volunteers performed two']","['Perceived Exertion (RPE', 'CHO supplementation', 'exercises at 50% VO 2peak  and 1% slope: exercise in hypoxia + placebo or exercise in hypoxia + CHO (6% maltodextrin', 'Carbohydrate supplementation', 'carbohydrate (CHO) supplementation']","['Area Under the Curve (AUC) of RPE', 'heart rate/RPE ratio', 'Oxygen Saturation', 'RPE increased in hypoxia', 'AUC of the HR/RPE ratio']","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C3538953', 'cui_str': 'Carbohydrate supplementation'}]","[{'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]",8.0,0.0376582,The RPE did not differ between groups.,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Tavares-Silva', 'Affiliation': 'Department of Psychobiology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'F F', 'Initials': 'FF', 'LastName': 'Donatto', 'Affiliation': 'Department of Bioscience, Universidade Federal de São Paulo, Rua Silva Jardim, 136 - Vila Mathias, Santos, SP, 11015-020, Brazil.'}, {'ForeName': 'R M V', 'Initials': 'RMV', 'LastName': 'Medeiros', 'Affiliation': 'Centro Universitário do Rio Grande do Norte (UNI-RN), Natal, Brazil.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Santos', 'Affiliation': 'Department of Bioscience, Universidade Federal de São Paulo, Rua Silva Jardim, 136 - Vila Mathias, Santos, SP, 11015-020, Brazil.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Caris', 'Affiliation': 'Department of Psychobiology, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'R V', 'Initials': 'RV', 'LastName': 'Thomatieli-Santos', 'Affiliation': 'Department of Psychobiology, Universidade Federal de São Paulo, São Paulo, Brazil. ronaldo.thomatieli@unifesp.br.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-019-0331-6']
1049,31521029,Effectiveness of an indigenous parent training program on change in parenting styles and delinquent tendencies (challenging behaviors) in Pakistan: A randomized controlled trial.,"The effectiveness of an indigenous parent training program was examined within selected Pakistani families. For this purpose, 110 parents of adolescents with above-average levels of delinquent tendencies (challenging behaviors), who were screened and chosen from five randomly selected schools in Lahore, Punjab, Pakistan, participated in the study. The adolescents' parents were randomly placed into either an intervention group or a control group. Members of the intervention group participated in seven sessions of parent training, which aimed to increase behaviors associated with an authoritative parenting style. Findings show that participants in the parent training program displayed an increase in authoritative parenting behaviors and a decrease in authoritarian and neglectful parenting behaviors at both posttest and follow-up. In addition, their children showed reductions in parent-reported challenging behaviors. Declines in challenging behaviors were explained by increases in authoritative parenting behaviors, although not all intervention effects could be explained by such increases. We conclude that, similar to Western countries, the authoritative parenting style is the most effective parenting style for managing adolescents' challenging behaviors in Pakistan.",2019,Findings show that participants in the parent training program displayed an increase in authoritative parenting behaviors and a decrease in authoritarian and neglectful parenting behaviors at both posttest and follow-up.,"[""adolescents' parents"", '110 parents of adolescents with above-average levels of delinquent tendencies (challenging behaviors), who were screened and chosen from five randomly selected schools in Lahore, Punjab, Pakistan, participated in the study', 'parenting styles and delinquent tendencies (challenging behaviors) in Pakistan']",['indigenous parent training program'],"['authoritative parenting behaviors', 'authoritarian and neglectful parenting behaviors']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0522175', 'cui_str': 'Delinquent'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0030211', 'cui_str': 'Islamic Republic of Pakistan'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1828250', 'cui_str': 'Neglectful parenting'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",110.0,0.0395175,Findings show that participants in the parent training program displayed an increase in authoritative parenting behaviors and a decrease in authoritarian and neglectful parenting behaviors at both posttest and follow-up.,"[{'ForeName': 'Rubina', 'Initials': 'R', 'LastName': 'Kauser', 'Affiliation': 'Faculty of Psychology, Philipps University Marburg, 35032 Marburg, Germany. Electronic address: rubina.kauser@staff.uni-marburg.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Pinquart', 'Affiliation': 'Faculty of Psychology, Philipps University Marburg, 35032 Marburg, Germany.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2019.104677']
1050,32434467,Practice facilitation to promote evidence-based screening and management of unhealthy alcohol use in primary care: a practice-level randomized controlled trial.,"BACKGROUND


Unhealthy alcohol use is the third leading cause of preventable death in the United States. Evidence demonstrates that screening for unhealthy alcohol use and providing persons engaged in risky drinking with brief behavioral and counseling interventions improves health outcomes, collectively termed screening and brief interventions. Medication assisted therapy (MAT) is another effective method for treatment of moderate or severe alcohol use disorder. Yet, primary care clinicians are not regularly screening for or treating unhealthy alcohol use.
METHODS AND ANALYSIS


We are initiating a clinic-level randomized controlled trial aimed to evaluate how primary care clinicians can impact unhealthy alcohol use through screening, counseling, and MAT. One hundred and 25 primary care practices in the Virginia Ambulatory Care Outcomes Research Network (ACORN) will be engaged; each will receive practice facilitation to promote screening, counseling, and MAT either at the beginning of the trial or at a 6-month control period start date. For each practice, the intervention includes provision of a practice facilitator, learning collaboratives with three practice champions, and clinic-wide information sessions. Clinics will be enrolled for 6-12 months. After completion of the intervention, we will conduct a mixed methods analysis to identify changes in screening rates, increase in provision of brief counseling and interventions as well as MAT, and the reduction of alcohol intake for patients after practices receive practice facilitation.
DISCUSSION


This study offers a systematic process for dissemination and implementation of the evidence-based practice of screening, counseling, and treatment for unhealthy alcohol use. Practices will be asked to implement a process for screening, counseling, and treatment based on their practice characteristics, patient population, and workflow. We propose practice facilitation as a robust and feasible intervention to assist in making changes within the practice. We believe that the process can be replicated and used in a broad range of clinical settings; we anticipate this will be supported by our evaluation of this approach.
TRIAL REGISTRATION


ClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT04248023, Registered 5 February 2020.",2020,"This study offers a systematic process for dissemination and implementation of the evidence-based practice of screening, counseling, and treatment for unhealthy alcohol use.",['One hundred and 25 primary care practices in the Virginia Ambulatory Care Outcomes Research Network (ACORN) will be engaged'],['Medication assisted therapy (MAT'],['health outcomes'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0557035', 'cui_str': 'Assisting with therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0890021,"This study offers a systematic process for dissemination and implementation of the evidence-based practice of screening, counseling, and treatment for unhealthy alcohol use.","[{'ForeName': 'Alison N', 'Initials': 'AN', 'LastName': 'Huffstetler', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA. Alison.huffstetler@vcuhealth.org.'}, {'ForeName': 'Anton J', 'Initials': 'AJ', 'LastName': 'Kuzel', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA.'}, {'ForeName': 'Roy T', 'Initials': 'RT', 'LastName': 'Sabo', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Richards', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'E Marshall', 'Initials': 'EM', 'LastName': 'Brooks', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA.'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Lail Kashiri', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Villalobos', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Arias', 'Affiliation': 'Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Dace', 'Initials': 'D', 'LastName': 'Svikis', 'Affiliation': 'Department of Psychology, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Bortz', 'Affiliation': 'Virginia Center for Health Innovation, Henrico, VA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'Virginia Center for Health Innovation, Henrico, VA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Epling', 'Affiliation': 'Department of Family and Community Medicine, Virginia Tech Carilion School of Medicine, Roanoke, VA, USA.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': 'Department of Family Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Parchman', 'Affiliation': 'MacColl Center, Kaiser Permanente of Washington Health Research Institute, Seattle, WA, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Winter', 'Affiliation': 'Shenandoah Valley Family Practice Residency, Virginia Commonwealth University, Front Royal, VA, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Wessler', 'Affiliation': 'Riverside Family Medicine Residency, Virginia Commonwealth University, Newport News, VA, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Yu', 'Affiliation': 'St. Francis Family Medicine Residency, Virginia Commonwealth University, Midlothian, VA, USA.'}, {'ForeName': 'Alex H', 'Initials': 'AH', 'LastName': 'Krist', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, One Capitol Square, Room 637, 830 East Main Street, Richmond, VA, 23219, USA.'}]",BMC family practice,['10.1186/s12875-020-01147-4']
1051,32105411,Association of adoption of transradial access for percutaneous coronary intervention in ST elevation myocardial infarction with door-to-balloon time.,"OBJECTIVES


We aimed to study adoption of transradial primary percutaneous coronary intervention (TR-PPCI) for ST elevation myocardial infarction (STEMI) (""radial first"" approach) and its association with door-to-balloon time (D2BT).
BACKGROUND


TR-PPCI for STEMI is underutilized in the United States due to concerns about prolonging D2BT. Whether operators and hospitals adopting a radial first approach in STEMI incur prolonged D2BT is unknown.
METHODS


In 1,272 consecutive cases of STEMI with PPCI at our hospital from January 1, 2011, to December 31, 2016, we studied TR-PPCI adoption and its association with D2BT including a propensity matched analysis of similar risk TR-PPCI and trans-femoral primary PCI (TF-PPCI) patients.
RESULTS


With major increases in hospital-level TR-PPCI (hospital TR-PPCI rate: 2.6% in 2011 to 79.4% in 2016, p-trend<.001) and operator-level TR-PPCI (mean operator TR-PPCI rate: 2.9% in 2011 to 81.1% in 2016, p-trend = .005), median hospital level D2BT decreased from 102 min [81, 142] in 2011 to 84 min [60, 105] in 2016 (p-trend<.001). TF crossover (10.3%; n = 57) was not associated with unadjusted D2BT (TR-PPCI success 91 min [72, 112] vs. TF crossover 99 min [70, 115], p = .432) or D2BT adjusted for study year and presenting location (7.2% longer D2BT with TF crossover, 95% CI: -4.0% to +18.5%, p = .208). Among 273 propensity-matched pairs, unadjusted D2BT (TR-PPCI 98 [78, 117] min vs. TF-PPCI 101 [76, 132] min, p = .304), and D2BT adjusted for study year and presenting location (5.0% shorter D2BT with TR-PPCI, 95% CI: -12.4% to +2.4%, p = .188) were similar.
CONCLUSIONS


TR-PPCI can be successfully implemented without compromising D2BT performance.",2020,"RESULTS


With major increases in hospital-level TR-PPCI (hospital TR-PPCI rate: 2.6% in 2011 to 79.4% in 2016, p-trend<.001) and operator-level TR-PPCI (mean operator TR-PPCI rate: 2.9% in 2011 to 81.1% in 2016, p-trend = .005)","['1,272 consecutive cases of STEMI with PPCI at our hospital from January 1, 2011, to December 31, 2016, we studied TR-PPCI adoption and its association with D2BT including a propensity matched analysis of similar risk TR-PPCI and trans-femoral primary PCI (TF-PPCI) patients']","['percutaneous coronary intervention', 'transradial primary percutaneous coronary intervention (TR-PPCI']","['hospital-level TR-PPCI (hospital TR-PPCI rate', 'operator-level TR-PPCI', 'D2BT performance', 'median hospital level D2BT']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0342675,"RESULTS


With major increases in hospital-level TR-PPCI (hospital TR-PPCI rate: 2.6% in 2011 to 79.4% in 2016, p-trend<.001) and operator-level TR-PPCI (mean operator TR-PPCI rate: 2.9% in 2011 to 81.1% in 2016, p-trend = .005)","[{'ForeName': 'Chetan P', 'Initials': 'CP', 'LastName': 'Huded', 'Affiliation': 'Heart and Vascular Institute Center for Healthcare Delivery Innovation, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Samir R', 'Initials': 'SR', 'LastName': 'Kapadia', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jad A', 'Initials': 'JA', 'LastName': 'Ballout', 'Affiliation': 'Medicine Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Krishnaswamy', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Ellis', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Raymond', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cho', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Simpfendorfer', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bajzer', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'A Michael', 'Initials': 'AM', 'LastName': 'Lincoff', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kravitz', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Venu', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hantz', 'Affiliation': 'Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Umesh N', 'Initials': 'UN', 'LastName': 'Khot', 'Affiliation': 'Heart and Vascular Institute Center for Healthcare Delivery Innovation, Cleveland Clinic, Cleveland, Ohio.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28785']
1052,32093850,Checkpoint Inhibitors in SCLC: How Much Can We Trust in Randomized Cohorts of Phase I/II Trials?,,2020,,['SCLC'],[],[],[],[],[],,0.0170941,,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Menis', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy; Medical Oncology Department, Istituto Oncologico Veneto IRCCS, Padova, Italy. Electronic address: j16menis@gmail.com.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'LungenClinic, Airway Research Center North (ARCN), German Center for Lung Research, Grosshansdorf, Germany.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.11.031']
1053,32078037,"Incorrect design and analysis render conclusion unsubstantiated: comment on ""A digital movement in the world of inactive children: favourable outcomes of playing active video games in a pilot randomized trial"".",,2020,,[],[],[],[],[],[],,0.138104,,"[{'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Golzarri-Arroyo', 'Affiliation': 'School of Public Health, Indiana University - Bloomington, Bloomington, IN, USA. lgolzarr@indiana.edu.'}, {'ForeName': 'Colby J', 'Initials': 'CJ', 'LastName': 'Vorland', 'Affiliation': 'School of Public Health, Indiana University - Bloomington, Bloomington, IN, USA.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Oakes', 'Affiliation': 'School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Ethan T', 'Initials': 'ET', 'LastName': 'Hunt', 'Affiliation': 'Department of Exercise Science, Arnold School of Public Health, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Brown', 'Affiliation': 'School of Public Health, Indiana University - Bloomington, Bloomington, IN, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Allison', 'Affiliation': 'School of Public Health, Indiana University - Bloomington, Bloomington, IN, USA.'}]",European journal of pediatrics,['10.1007/s00431-020-03590-y']
1054,32131801,Dental professionals' experiences of managing children with carious lesions in their primary teeth - a qualitative study within the FiCTION randomised controlled trial.,"BACKGROUND


The lack of evidence for the effective management of carious lesions in children's primary teeth has caused uncertainty for the dental profession and patients. Possible approaches include conventional and biological management alongside best practice prevention, and best practice prevention alone. The FiCTION trial assessed the effectiveness of these options, and included a qualitative study exploring dental professionals' (DPs) experiences of delivering the different treatment arms. This paper reports on how DPs managed children with carious lesions within FiCTION and how this related to their everyday experiences of doing dentistry.
METHODS


Overall, 31 DPs from FiCTION-trained dental surgeries in four regions of the UK participated in semi-structured interviews about their experiences of the three treatment arms (conventional management of carious lesions and prevention (C + P), biological management of carious lesions and prevention (B + P) or prevention alone (PA)). A theoretical framework, drawing on social practice theory (SPT), was developed for analysis.
RESULTS


Participants discussed perceived effectiveness of, and familiarity with, the three techniques. The C + P arm was familiar, but some participants questioned the effectiveness of conventional restorations. Attitudes towards the B + P arm varied in terms of familiarity, but once DPs were introduced to the techniques, this was seen as effective. While prevention was familiar, PA was described as ineffective. DPs manage children with carious lesions day-to-day, drawing on previous experience and knowledge of the child to provide what they view as the most appropriate treatment in the best interests of each child. Randomisation undermined these normal choices. Several DPs reported deviating from the trial arms in order to treat a patient in a particular way. Participants valued evidence-based dentistry, and expect to use the results of FiCTION to inform future practice. They anticipate continuing to use the full range of treatment options, and to personally select appropriate strategies for individual children.
CONCLUSIONS


RCTs take place in the context of day-to-day practices of doing dentistry. DPs employ experiential and interpersonal knowledge to act in the best interests of their patients. Randomisation within a clinical trial can present a source of tension for DPs, which has implications for assuring individual equipoise in future trials.",2020,"Attitudes towards the B + P arm varied in terms of familiarity, but once DPs were introduced to the techniques, this was seen as effective.","[""Dental professionals' experiences of managing children with carious lesions in their primary teeth "", ""children's primary teeth"", 'DPs managed children with carious lesions']",[],[],"[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011334', 'cui_str': 'Dental Decay'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}]",[],[],,0.0399188,"Attitudes towards the B + P arm varied in terms of familiarity, but once DPs were introduced to the techniques, this was seen as effective.","[{'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Marshman', 'Affiliation': 'School of Clinical Dentistry, Claremont Crescent, Sheffield, S10 2TA, UK.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Kettle', 'Affiliation': 'School of Clinical Dentistry, Claremont Crescent, Sheffield, S10 2TA, UK.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Holmes', 'Affiliation': 'School of Dental Sciences, Faculty of Medical Sciences, Newcastle University, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Cunningham', 'Affiliation': 'School of Medicine, University of St Andrews, North Haugh, St Andrews, KY16 9TF, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Freeman', 'Affiliation': 'Dental Health Services Research Unit, School of Dentistry, Park Place, Dundee, DD1 4HN, UK.'}, {'ForeName': 'Barry J', 'Initials': 'BJ', 'LastName': 'Gibson', 'Affiliation': 'School of Clinical Dentistry, Claremont Crescent, Sheffield, S10 2TA, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Newcastle Clinical Trials Unit, 4th Floor, William Leech Building, Framlington Place, Newcastle Upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Maguire', 'Affiliation': 'School of Dental Sciences, Faculty of Medical Sciences, Newcastle University, Framlington Place, Newcastle upon Tyne, NE2 4HH, UK.'}, {'ForeName': 'Gail V A', 'Initials': 'GVA', 'LastName': 'Douglas', 'Affiliation': 'Leeds Dental Institute, Clarendon Way, Leeds, LS2 9LU, UK.'}, {'ForeName': 'Janet E', 'Initials': 'JE', 'LastName': 'Clarkson', 'Affiliation': 'Dental Health Services Research Unit, School of Dentistry, Park Place, Dundee, DD1 4HN, UK.'}, {'ForeName': 'Nicola P T', 'Initials': 'NPT', 'LastName': 'Innes', 'Affiliation': 'School of Dentistry, University of Dundee, Park Place, Dundee, DD1 4HN, UK. n.p.Innes@dundee.ac.uk.'}]",BMC oral health,['10.1186/s12903-020-1051-7']
1055,31512072,"Photo-activated implants: a triple-blinded, split-mouth, randomized controlled clinical trial on the resistance to removal torque at various healing intervals.","OBJECTIVES


Hydrophilic implant surfaces promote faster osseointegration of dental implants with a higher bone-implant contact (BIC) rate. Animal and in vitro studies proved that ultraviolet (UV) irradiation of titanium implants regains hydrophilicity. Clinical impact is still unclear. The objective of this RCT was to assess the removal torque (RT) required to unfix a surface-treated implant (test group) versus the original surface implant (control group) performed at various points in time. The null hypothesis stated that test and control implants will show the same deliberation force at specific time points.
MATERIAL AND METHODS


One hundred eighty partially edentulous patients were randomly assigned to six groups. In single-stage surgery, each patient received one test and one control implant. In total, 180 test and 180 control implants were placed epicrestally. Test implants received a surface treatment with UV irradiation prior to insertion, in order to reduce carbon and enhance hydrophilicity and thus wettability. Maximum RT values for test and control implants were recorded with a torque measuring device at implant placement (T1), after 1 (group 1), 2 (group 2), 3 (group 3), 4 (group 4), 6 (group 5) (T2), and 8 weeks (group 6) of healing. Subsequently, implants were returned to their original position for the continuation of the healing process.
RESULTS


No implant was lost. Age, gender, smoking, implant position, and bone quality could be excluded as confounding factors because of the lack of statistical significance. At T2, RT values were higher for test implants compared with those for control implants, being statistically significant in groups 2, 3, 4, and 6 (p < 0.05).
CONCLUSIONS


Our data support rejection of the null hypothesis.
CLINICAL RELEVANCE


Photo-activation of the surface of titanium implants leads to higher resistance to RT forces compared with that of non-treated implants, indicating improved healing and implant stability especially in the early healing phase.",2020,"At T2, RT values were higher for test implants compared with those for control implants, being statistically significant in groups 2, 3, 4, and 6 (p < 0.05).
","['dental implants with a higher bone-implant contact (BIC) rate', 'One hundred eighty partially edentulous patients']","['Photo-activated implants', 'ultraviolet (UV) irradiation']","['RT values', 'Maximum RT values', 'removal torque (RT', 'healing and implant stability']","[{'cui': 'C0011373', 'cui_str': 'Dental Implants'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0026644', 'cui_str': 'Mouth, Toothless'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1532472', 'cui_str': 'Ultraviolet'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C2828363', 'cui_str': 'Implant'}]",180.0,0.0619305,"At T2, RT values were higher for test implants compared with those for control implants, being statistically significant in groups 2, 3, 4, and 6 (p < 0.05).
","[{'ForeName': 'Algirdas', 'Initials': 'A', 'LastName': 'Puisys', 'Affiliation': ', Vilnius, Lithuania.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schlee', 'Affiliation': ', Forchheim, Germany. markus.schlee@32schoenezaehne.de.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Linkevicius', 'Affiliation': ', Vilnius, Lithuania.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Petrakakis', 'Affiliation': ', Duesseldorf, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Tjaden', 'Affiliation': ', Forchheim, Germany.'}]",Clinical oral investigations,['10.1007/s00784-019-03041-5']
1056,31937586,Effect of rovatirelin in patients with cerebellar ataxia: two randomised double-blind placebo-controlled phase 3 trials.,"OBJECTIVE


To investigate the efficacy of rovatirelin, a thyrotropin-releasing hormone analogue, for ataxias in patients with spinocerebellar degeneration (SCD).
METHODS


Two multicentre, randomised, double-blind, placebo-controlled phase 3 studies (KPS1301, KPS1305) enrolled patients with predominant cerebellar ataxia, including SCA6, SCA31 or cortical cerebellar atrophy. KPS1301 enrolled patients with truncal ataxia and KPS1305 enrolled patients with truncal and limb ataxia. Each study included 4 weeks of pretreatment, a 28-week or 24-week treatment period and 4 weeks of follow-up. Patients were randomised (1:1:1) to rovatirelin (1.6 or 2.4 mg) or placebo in KPS1301, and randomised (1:1) to rovatirelin 2.4 mg or placebo in KPS1305. The primary endpoint was change in Scale for the Assessment and Rating of Ataxia (SARA) total scores. Pooled analysis was performed in patients who met the SARA recruitment criteria of KPS1305.
RESULTS


From October 2013 to May 2014, KPS1301 enrolled 411 patients; 374 were randomised to rovatirelin 1.6 mg (n=125), rovatirelin 2.4 mg (n=126) or placebo (n=123). From November 2016 to August 2017, KPS1305 enrolled 241 patients; 203 were randomised to rovatirelin 2.4 mg (n=101) or placebo (n=102). The primary endpoint showed no significant difference between rovatirelin and placebo in these two studies. In the pooled analysis (n=278), the difference between rovatirelin 2.4 mg (n=140) and placebo (n=138) was -0.61 (-1.64 vs -1.03; 95% CI -1.16 to -0.06; p=0.029) in the adjusted mean change in the SARA total score.
CONCLUSIONS


Rovatirelin is a potentially effective treatment option for SCD.
TRIAL REGISTRATION NUMBER


NCT01970098; NCT02889302.",2020,The primary endpoint showed no significant difference between rovatirelin and placebo in these two studies.,"['patients with spinocerebellar degeneration (SCD', 'From October 2013 to May 2014, KPS1301 enrolled 411 patients; 374', 'patients with cerebellar ataxia', 'enrolled patients with predominant cerebellar ataxia, including SCA6, SCA31 or cortical cerebellar atrophy', 'From November 2016 to August 2017, KPS1305 enrolled 241 patients; 203', 'enrolled patients with truncal ataxia and KPS1305 enrolled patients with truncal and limb ataxia']","['placebo-controlled phase 3 studies (KPS1301, KPS1305', 'rovatirelin 1.6\u2009mg (n=125), rovatirelin 2.4\u2009mg (n=126) or placebo', 'placebo in KPS1301', 'rovatirelin, a thyrotropin-releasing hormone analogue', 'rovatirelin', 'rovatirelin 2.4\u2009mg (n=101) or placebo', 'placebo', 'KPS1301', 'rovatirelin 2.4\u2009mg or placebo in KPS1305']","['change in Scale for the Assessment and Rating of Ataxia (SARA) total scores', 'SARA total score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037952', 'cui_str': 'Spinocerebellar Diseases'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0007758', 'cui_str': 'Cerebellar Incoordination'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0740279', 'cui_str': 'Cerebellar atrophy'}, {'cui': 'C0427190', 'cui_str': 'Ataxia, Truncal'}, {'cui': 'C0750937', 'cui_str': 'Ataxia, Appendicular'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4278752', 'cui_str': 'rovatirelin'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0040162', 'cui_str': 'protirelin'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0004134', 'cui_str': 'Dyssynergia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",411.0,0.652056,The primary endpoint showed no significant difference between rovatirelin and placebo in these two studies.,"[{'ForeName': 'Masatoyo', 'Initials': 'M', 'LastName': 'Nishizawa', 'Affiliation': 'Brain Research Institute, Niigata University, Niigata, Japan nishizawamasatoyo@gmail.com.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Onodera', 'Affiliation': 'Department of Neurology, Brain Research Institute, Niigata University, Niigata, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Hirakawa', 'Affiliation': 'Department of Biostatistics and Bioinformatics, The University of Tokyo, Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': 'Strategic Alliance Department, Kissei Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Clinical Data Science Department, Kissei Pharmaceutical Co., Ltd, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2019-322168']
1057,31982359,"A Double Blind, Placebo Controlled, Randomized Trial to Evaluate the Efficacy and Tolerability of On-Demand Oral Pregablin (150 mg and 75 mg) in Treatment of Premature Ejaculation.","INTRODUCTION


Although premature ejaculation (PE) is a common sexual dysfunction, the available options for PE treatment remain unsatisfactory.
AIM


To evaluate the effect of on-demand oral pregabalin on the intravaginal ejaculation latency time (IELT).
METHOD


We conducted a multiarm double-blinded placebo-controlled randomized clinical trial that enrolled 120 patients with PE who were divided equally into 3 groups (A, B, and C). 4 patients were excluded, 39 patients received 150 mg pregabalin (group A), 39 patients received 75 mg pregabalin (group B), and 38 patients received placebo (group C). All patients were encouraged to engage in sexual relations twice per week for 2 weeks and to take the medication 1-2 hours before sexual intercourse. A stopwatch was used to evaluate IELT.
MAIN OUTCOME MEASURE


The main outcome measure are the improvement of IELT and the reported adverse events.
RESULTS


IELT significantly improved in patients who received 150 mg pregabalin, but there was no change in the other groups.
CLINICAL IMPLICATIONS


Most PE patients showed a significant improvement after receiving on-demand pregabalin (150 mg).
STRENGTH & LIMITATIONS


The strength of this study is that it is the first randomized controlled trial to evaluate the efficacy of pregabalin in treatment of PE. The main limitations were the small number of patients, IELT was the only primary outcome of the study, and the pregabalin cap can be identified by the patient.
CONCLUSION


Oral pregabalin seems to be a promising drug for additional evaluation as a new treatment for PE. More studies are needed to evaluate the suitable dose, duration, timing, and its safety profile. El Najjar MR, El Hariri M, Ramadan A, et al. A Double Blind, Placebo Controlled, Randomized Trial to Evaluate the Efficacy and Tolerability of On-Demand Oral Pregablin (150 mg and 75 mg) in Treatment of Premature Ejaculation. J Sex Med 2020;17:442-446.",2020,"RESULTS


IELT significantly improved in patients who received 150 mg pregabalin, but there was no change in the other groups.
","['4 patients were excluded, 39 patients received', 'enrolled 120 patients with PE who were divided equally into 3 groups (A, B, and C']","['Placebo', 'demand oral pregabalin', 'multiarm double-blinded placebo', 'pregabalin', 'placebo', '150\xa0mg pregabalin', 'Demand Oral Pregablin']","['improvement of IELT and the reported adverse events', 'Efficacy and Tolerability', 'intravaginal ejaculation latency time (IELT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",120.0,0.0783644,"RESULTS


IELT significantly improved in patients who received 150 mg pregabalin, but there was no change in the other groups.
","[{'ForeName': 'Mohamed Refaat', 'Initials': 'MR', 'LastName': 'El Najjar', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Al Azhar University, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Hariri', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Al Azhar University, Cairo, Egypt. Electronic address: mhaririderma@gmail.com.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ramadan', 'Affiliation': 'Dermatology and Venereology Department, Faculty of Medicine, Al Azhar University, Cairo, Egypt.'}, {'ForeName': 'Abd-Alrahman', 'Initials': 'AA', 'LastName': 'Hefny Hashem', 'Affiliation': 'Dermatology and Venereology Department, Bilbeis Hospital, Al Sharqia, Egypt.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.12.014']
1058,31369328,"Impacts of aquatic walking on arterial stiffness, exercise tolerance, and physical function in patients with peripheral artery disease: a randomized clinical trial.","Peripheral artery disease (PAD) is an atherosclerotic disease that is associated with attenuated vascular function, cardiorespiratory capacity, physical function, and muscular strength. It is essential to combat these negative effects on health by incorporating lifestyle interventions to slow disease progression, such as exercise. We sought to examine the effects of aquatic walking exercise on cardiovascular function, cardiorespiratory capacity [maximal volume of oxygen consumption (V̇o 2max )], exercise tolerance [6-min walking distance (6MWD)], physical function, muscular strength, and body composition in patients with PAD. Patients with PAD ( n  = 72) were recruited and randomly assigned to a 12-wk aquatic walking training group (AQ,  n  = 35) or a control group (CON,  n  = 37). The AQ group performed walking and leg exercises in waist-to-chest-deep water. Leg arterial stiffness [femoral-to-ankle pulse wave velocity (legPWV)], heart rate (HR), blood pressure (BP), ankle-to-brachial index (ABI), V̇o 2max , 6MWD, physical function, muscular strength, body composition, resting metabolic rate (RMR), and flexibility were measured before and after 12 wk. There were significant group × time interactions ( P  < 0.05) after 12 wk for legPWV and HR, which significantly decreased ( P  < 0.05) in AQ, and V̇o 2max , 6MWD, physical function, and muscular strength, which significantly increased ( P  < 0.05) in AQ, compared with no changes in CON. There were no significant differences ( P  > 0.05) for BP, ABI, RMR, or flexibility after 12 wk. Interestingly, there was relatively high adherence (84%) to the aquatic walking exercise program in this population. These results suggest that aquatic walking exercise is an effective therapy to reduce arterial stiffness and resting HR and improve cardiorespiratory capacity, exercise tolerance, physical function, and muscular strength in patients with PAD. NEW & NOTEWORTHY  The results of this study reveal for the first time that aquatic walking exercise can decrease arterial stiffness and improve exercise tolerance, cardiorespiratory capacity, and muscular strength in patients with peripheral artery disease (PAD). Aquatic walking exercise training demonstrates relatively high exercise adherence in this population. Aquatic walking exercise training may be a useful therapeutic intervention for improving physical function in patients with PAD.",2019,"There were no significant differences ( p >0.05) for BP, ABI, RMR, or flexibility after 12 weeks.","['patients with PAD', 'patients with peripheral artery disease', 'Patients with PAD ( n =72']","['AQ group performed walking and leg exercises', 'aquatic walking exercise program', 'aquatic walking', 'aquatic walking training group (AQ,  n =35) or control (CON', 'aquatic walking exercise']","['cardiovascular function, cardiorespiratory capacity (VO 2 max), exercise tolerance (6-minute walking distance, 6MWD), physical function, muscular strength, and body composition', 'time interactions', 'arterial stiffness, exercise tolerance & physical function', 'BP, ABI, RMR, or flexibility', 'VO 2 max, 6MWD, physical function, and muscular strength', 'arterial stiffness and resting HR, and improve cardiorespiratory capacity, exercise tolerance, physical function, and muscular strength', 'Leg arterial stiffness (femoral-to-ankle pulse-wave velocity, legPWV), heart rate (HR), blood pressure (BP), ankle-to-brachial index (ABI), VO 2 max, 6MWD, physical function, muscular strength, body composition, resting metabolic rate (RMR), and flexibility']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0454361', 'cui_str': 'Lower limb exercises (regime/therapy)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0232154', 'cui_str': 'Ankle pulse'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0445456', 'cui_str': 'Brachial (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}]",,0.02033,"There were no significant differences ( p >0.05) for BP, ABI, RMR, or flexibility after 12 weeks.","[{'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Yi-Sub', 'Initials': 'YS', 'LastName': 'Kwak', 'Affiliation': 'Department of Physical Education, Dong-Eui University, Busan, South Korea.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Pekas', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00209.2019']
1059,31504831,The Presence and Persistence of Unrealistic Expectations in Patients Undergoing Nerve Surgery.,"BACKGROUND


Unrealistic expectations of the outcomes of peripheral nerve surgery reduce patient satisfaction. Most clinicians can recall patients with unrealistic expectations despite verbal preoperative education.
OBJECTIVE


To assess patients' baseline level of understanding regarding nerve surgery and appropriate expectations. Additionally, we tested the effect of a written, preoperative educational handout on the patients' retention of knowledge.
METHODS


This cross-sectional survey recruited patients scheduled to undergo peripheral nerve surgery at a single institution in 2016 to 2017. During the preoperative visit, a specialized nurse practitioner reviewed perioperative protocols, risks and benefits of the surgery, and postoperative care. Patients immediately completed a survey to assess their preoperative understanding of the verbally reviewed information. During the same visit, an additional written handout was given to patients in a randomized fashion. At their first postoperative visit, all patients completed the survey again.
RESULTS


A total of 60 patients (mean age 52 yr) were enrolled of which 62% were male. Immediately following verbal instruction, 31% of patients had erroneous (unrealistic) expectations regarding pain, 30% had erroneous expectations regarding postoperative motor outcome, and 41% had erroneous expectations regarding the timing of postoperative recovery. There was no significant difference between patients who received the written handout vs those who did not, on retesting in the postoperative period.
CONCLUSION


Patients undergoing peripheral nerve procedures demonstrated a high baseline level of unrealistic expectations despite standard in-person verbal counseling by specialty providers. A written handout did not have clear benefit in the retention of preoperative surgical teaching. Further investigation into more effective preoperative patient counseling is needed.",2020,"There was no significant difference between patients who received the written handout vs those who did not, on retesting in the postoperative period.
","['Patients Undergoing Nerve Surgery', 'patients scheduled to undergo peripheral nerve surgery at a single institution in 2016 to 2017', '60 patients (mean age 52 yr) were enrolled of which 62% were male']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0031119', 'cui_str': 'Peripheral Nerves'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],[],,0.067368,"There was no significant difference between patients who received the written handout vs those who did not, on retesting in the postoperative period.
","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kirsch', 'Affiliation': 'School of Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Brandon W', 'Initials': 'BW', 'LastName': 'Smith', 'Affiliation': 'Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Kate W C', 'Initials': 'KWC', 'LastName': 'Chang', 'Affiliation': 'Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Sravanthi', 'Initials': 'S', 'LastName': 'Koduri', 'Affiliation': 'Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Lynda J S', 'Initials': 'LJS', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.'}]",Neurosurgery,['10.1093/neuros/nyz335']
1060,32436453,Enhancing employee wellness: Translating an effective community behavioral weight-loss treatment to the worksite.,"BACKGROUND


As rates of obesity continue to rise in the USA, there is a need for effective treatments for excess adiposity. Behavioral weight-loss interventions can produce clinically meaningful weight reduction through life-style modifications. However, few studies have evaluated the effectiveness of high-intensity behavioral weight-loss interventions at worksites.
AIM


The present research investigated the effectiveness of a previously validated behavioral weight-loss intervention in a Hawai'i worksite.
METHODS


Thirty-six participants were recruited from the employee population of a local employer. Participants received six months of group behavioral weight-loss treatment from trained providers. Anthropomorphic, physiological, psychological, and behavioral assessments were collected pre and post treatment. Select physiological and behavioral assessments were collected every four sessions.
RESULTS


Sixty-one percent of participants adhered to treatment, and 78% of participants completed treatment. From pre to post treatment, results found that participants achieved clinically significant improvements in weight, body mass index (BMI), and waist circumference, with accompanying physiological, psychological, and behavioral improvements ( F (12, 2)=101.379,  p =0.010, partial η 2 =0.998). Analyses revealed that participants also achieved significant changes in weight, BMI, and waist circumference across time points, as well as improvements in specific eating habits.
CONCLUSIONS


The present study demonstrated the efficacy of a worksite behavioral weight-loss program. The present intervention produced clinically significant weight losses for a large proportion of participants, accompanied by significant improvements in physiological, behavioral, and psychological outcomes. This research is promising for the ongoing implementation of behavioral weight-loss approaches.",2020,"The present intervention produced clinically significant weight losses for a large proportion of participants, accompanied by significant improvements in physiological, behavioral, and psychological outcomes.",['Thirty-six participants were recruited from the employee population of a local employer'],"['behavioral weight-loss intervention', 'worksite behavioral weight-loss program', 'Behavioral weight-loss interventions']","['Anthropomorphic, physiological, psychological, and behavioral assessments', 'weight, body mass index (BMI), and waist circumference, with accompanying physiological, psychological, and behavioral improvements', 'physiological, behavioral, and psychological outcomes', 'weight losses', 'weight, BMI, and waist circumference across time points, as well as improvements in specific eating habits']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1274022', 'cui_str': 'Employer'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1160858', 'cui_str': 'Behavior assessment'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",36.0,0.0290067,"The present intervention produced clinically significant weight losses for a large proportion of participants, accompanied by significant improvements in physiological, behavioral, and psychological outcomes.","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Murakami', 'Affiliation': 'VA Pacific Islands Healthcare System, USA.'}, {'ForeName': 'Brooke L', 'Initials': 'BL', 'LastName': 'Bennett', 'Affiliation': ""Department of Psychology, University of Hawai'i at Mānoa, USA.""}, {'ForeName': 'Devin', 'Initials': 'D', 'LastName': 'Rand-Giovannetti', 'Affiliation': ""Department of Psychology, University of Hawai'i at Mānoa, USA.""}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Stefano', 'Affiliation': ""Department of Psychology, University of Hawai'i at Mānoa, USA.""}, {'ForeName': 'Janet D', 'Initials': 'JD', 'LastName': 'Latner', 'Affiliation': ""Department of Psychology, University of Hawai'i at Mānoa, USA.""}]",Nutrition and health,['10.1177/0260106020926834']
1061,31257435,"Effectiveness of an intervention to improve antibiotic-prescribing behaviour in primary care: a controlled, interrupted time-series study.","BACKGROUND


High rates of antibiotic misprescribing in primary care, with alarming clinical and economic consequences, highlight the urgent need for interventions to improve antibiotic prescribing in this setting.
OBJECTIVES


To assess the effectiveness on antibiotic prescribing quality indicators of a multifaceted intervention targeting health professionals' and patients' behaviour regarding antibiotic use.
METHODS


We conducted a pragmatic cluster-randomized controlled trial in the catchment area covered by Portugal's Central Regional Health Administration. The intervention consisted of a multidisciplinary, multifaceted programme involving physicians, pharmacists and patients, and comprising outreach visits for physicians and pharmacists, and educational materials for health professionals and patients. The following were assessed: relative ratios of prescription of penicillins sensitive to β-lactamase, penicillin combinations including β-lactamase inhibitors, third- and fourth-generation cephalosporins and fluoroquinolones; and the ratio of broad- to narrow-spectrum antibiotics. An interrupted time-series analysis for multiple-group comparisons was performed. The study protocol was registered on Clinical.trials.gov (NCT02173509).
RESULTS


The participation rate in the educational intervention was 64% (197/309 GPs) in a total of 25 counties. Statistically significant improvements were obtained, not only in the relative prescription of penicillins sensitive to β-lactamase (overall relative change of +896%) and penicillin combinations including β-lactamase inhibitors (-161%), but also in the ratio of broad- to narrow-spectrum antibiotics (-200%). Statistically significant results were also obtained for third- and fourth-generation cephalosporins, though only in the immediate term.
CONCLUSIONS


This study showed that quality indicators of antibiotic prescribing can be improved by tackling influences on behaviour including knowledge and attitudes surrounding physicians' clinical practice. Accordingly, these determinants must be considered when implementing interventions aimed at improving antibiotic prescribing.",2019,"Statistically significant results were also obtained for third- and fourth-generation cephalosporins, though only in the immediate term.
",['primary care'],"['multidisciplinary, multifaceted programme involving physicians, pharmacists and patients, and comprising outreach visits for physicians and pharmacists, and educational materials for health professionals and patients']","['participation rate', 'antibiotic-prescribing behaviour', 'relative ratios of prescription of penicillins sensitive to β-lactamase, penicillin combinations including β-lactamase inhibitors, third- and fourth-generation cephalosporins and fluoroquinolones; and the ratio of broad- to narrow-spectrum antibiotics']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for (contextual qualifier) (qualifier value)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1264683', 'cui_str': 'Relative ratio'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0030842', 'cui_str': 'Antibiotics, Penicillin'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0361823', 'cui_str': 'Fourth generation cephalosporin (substance)'}, {'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}]",,0.110527,"Statistically significant results were also obtained for third- and fourth-generation cephalosporins, though only in the immediate term.
","[{'ForeName': 'António', 'Initials': 'A', 'LastName': 'Teixeira Rodrigues', 'Affiliation': 'Institute of Biomedicine - iBiMED, Department of Medical Sciences, University of Aveiro, Aveiro, Portugal.'}, {'ForeName': 'Fátima', 'Initials': 'F', 'LastName': 'Roque', 'Affiliation': 'Institute of Biomedicine - iBiMED, Department of Medical Sciences, University of Aveiro, Aveiro, Portugal.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Piñeiro-Lamas', 'Affiliation': 'Consortium for Biomedical Research in Epidemiology and Public Health (CIBER Epidemiología y Salud Pública-CIBERESP), University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Amílcar', 'Initials': 'A', 'LastName': 'Falcão', 'Affiliation': 'Faculty of Pharmacy, University of Coimbra (FFUC), Coimbra, Portugal.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'Figueiras', 'Affiliation': 'Consortium for Biomedical Research in Epidemiology and Public Health (CIBER Epidemiología y Salud Pública-CIBERESP), University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Herdeiro', 'Affiliation': 'Institute of Biomedicine - iBiMED, Department of Medical Sciences, University of Aveiro, Aveiro, Portugal.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkz244']
1062,31443893,Mindfulness practice predicts interleukin-6 responses to a mindfulness-based alcohol relapse prevention intervention.,"Chronic alcohol misuse can result in chronically elevated interleukin (IL)-6, a pro-inflammatory cytokine, in the bloodstream. Given that Mindfulness-Based Relapse Prevention (MBRP) has been shown to reduce alcohol misuse, MBRP might also be effective in reducing IL-6 concentrations. Past research has found, however, that IL-6 does not respond consistently to mindfulness-based interventions. Building on prior studies, we examined whether between-person variability in engagement with mindfulness training (i.e., formal mindfulness practice time) is associated with between-person variability in changes in serum IL-6, using data from a randomized controlled trial evaluating MBRP for Alcohol Dependence (MBRP-A). Participants were 72 alcohol dependent adults (mean age = 43.4 years, 63.9% male, 93.1% White) who received a minimum dose (i.e., at least four sessions) of MBRP-A either at the start of the trial (n = 46) or after a 26-week delay (n = 26). IL-6 concentrations did not significantly change from pre- to post-intervention for the full sample. Nevertheless, greater mindfulness practice time was significantly associated with reduced IL-6 levels (r = -0.27). The association between practice time and IL-6 changes remained significant when controlling for intervention timing (i.e., immediate or after the 26-week delay), demographic characteristics, and changes in mindful awareness, obsessive-compulsive drinking, and depressive symptoms. The association between practice time and IL-6 changes was not significant when omitting the minimum treatment dose requirement. Overall, results suggest that the level of engagement in mindfulness training may predict changes in the inflammatory pathophysiology in adults with alcohol dependence.",2019,"Nevertheless, greater mindfulness practice time was significantly associated with reduced IL-6 levels (r = -0.27).","['Participants were 72 alcohol dependent adults (mean age\u202f=\u202f43.4\u202fyears, 63.9% male, 93.1% White) who received a minimum dose (i.e., at least four sessions) of MBRP-A either at the start of the trial (n\u202f=\u202f46) or after a 26-week delay (n\u202f=\u202f26', 'adults with alcohol dependence']","['Mindfulness-Based Relapse Prevention (MBRP', 'mindfulness training', 'IL-6']","['mindful awareness, obsessive-compulsive drinking, and depressive symptoms', 'reduced IL-6 levels', 'IL-6 concentrations', 'mindfulness practice time', 'practice time and IL-6 changes']","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",72.0,0.0290657,"Nevertheless, greater mindfulness practice time was significantly associated with reduced IL-6 levels (r = -0.27).","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'McClintock', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, United States of America. Electronic address: asmcclintock@wisc.edu.'}, {'ForeName': 'Simon B', 'Initials': 'SB', 'LastName': 'Goldberg', 'Affiliation': 'Department of Counseling Psychology, University of Wisconsin-Madison, United States of America.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Coe', 'Affiliation': 'Department of Psychology, University of Wisconsin-Madison, United States of America.'}, {'ForeName': 'Aleksandra E', 'Initials': 'AE', 'LastName': 'Zgierska', 'Affiliation': 'Department of Family Medicine and Community Health, University of Wisconsin-Madison, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.07.018']
1063,31501493,Effect of angiotensin II receptor blocker and salt supplementation on short-term blood pressure variability in type 2 diabetes.,"High blood pressure variability (BPV) has been associated with increased cardiovascular (CV) risk. The effect of dietary salt and renin-angiotensin-aldosterone system (RAAS) activity on short-term BPV in type 2 diabetes mellitus (T2DM) is not well characterised. We aimed to determine the effect of dietary salt (sodium chloride, NaCl) supplementation on 24-h mean arterial BPV (24hBPV) during angiotensin II receptor blocker (telmisartan) use and to evaluate the effects of age, sex, plasma renin activity (PRA) and serum aldosterone on 24hBPV. In a randomised, double-blind, crossover study, patients with T2DM (n = 28), treated with telmisartan received NaCl (100 mmol/24 h) or placebo capsules during 2 weeks of telmisartan. Following a 6-week washout, the protocol was repeated in reverse. 24hBPV was evaluated as a co-efficient of variation [CV (%) = mean/standard deviation] × 100). Twenty-four hour urinary sodium excretion, ambulatory BP and biochemical tests were performed at each phase. Results were analysed using a linear mixed model to generate predicted values for 24hBPV. Predicted 24hBPV was higher with telmisartan vs baseline (p = 0.01), with a trend towards reduced 24hBPV with salt (p = 0.052). Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011). In patients with T2DM, predicted 24hBPV increased from baseline with telmisartan, but there was no additional increase in predicted 24hBPV with salt supplementation. This suggests that in the short-term, salt supplementation has no apparent deleterious effects on 24hBPV. Long-term studies are required to evaluate the effect of 24hBPV on CV outcomes in patients with T2DM.",2020,"Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011).","['patients with T2DM (n\u2009=\u200928), treated with', 'type 2 diabetes', 'type 2 diabetes mellitus (T2DM', 'patients with T2DM']","['telmisartan', 'telmisartan received NaCl', '24hBPV', 'dietary salt (sodium chloride, NaCl) supplementation', 'placebo', 'angiotensin II receptor blocker and salt supplementation', 'angiotensin II receptor blocker (telmisartan', 'dietary salt and renin-angiotensin-aldosterone system (RAAS) activity']","['urinary sodium excretion, ambulatory BP and biochemical tests', 'Predicted 24hBPV', 'cardiovascular (CV) risk', '24hBPV', 'CV outcomes', 'High blood pressure variability (BPV', 'short-term blood pressure variability', 'PRA', '24-h mean arterial BPV (24hBPV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0248719', 'cui_str': 'telmisartan'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II Receptor Blockers'}, {'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0020538', 'cui_str': 'Blood Pressure, High'}, {'cui': 'C0531207', 'cui_str': 'bpV(phen)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}]",,0.0546638,"Predicted 24hBPV was lower in females (p = 0.017), increasing age (p = 0.001) and increasing PRA (p = 0.011).","[{'ForeName': 'Angela X', 'Initials': 'AX', 'LastName': 'Chen', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Moran', 'Affiliation': 'Queen Elizabeth Hospital, Adelaide, SA, Australia.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Libianto', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Baqar', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': ""O'Callaghan"", 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'MacIsaac', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Jerums', 'Affiliation': 'Department of Medicine, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Elif I', 'Initials': 'EI', 'LastName': 'Ekinci', 'Affiliation': 'Department of Endocrinology, Austin Health, Melbourne, VIC, Australia. elif.ekinci@unimelb.edu.au.'}]",Journal of human hypertension,['10.1038/s41371-019-0238-3']
1064,32436724,Evaluation of a brief interval exercise training (IET) intervention for first-time prisoners with elevated anxiety symptoms.,"ABSTRACT   Background:  Exercise training has a history of alleviating anxiety in various populations, but research into its effects on prison inmates is limited. Confinement to prison is a highly distressing event for those who have never experienced incarceration, which can dramatically increase anxiety-related symptoms and may exacerbate suicidal risk.  Methods:  Thirty-seven first-time prisoners with elevated anxiety symptoms completed the State-Trait Anxiety Inventory before and after a 6-week long treatment period consisting of interval exercise training (IET;  n  = 20) or no intervention (waiting-list;  n  = 17). Prisoners in the IET intervention had to exercise three times per week (40 min per session) under the supervision of the first and/or second author. Exercise intensity was self-monitored using the Borg's RPE-15 scale, with targets in the range 13-15 (""somewhat hard""-""hard"").  Results:  Those who received the IET intervention showed a significantly greater reduction in anxiety than prisoners in the waiting-list. The effect size for IET was of moderate-to-large magnitude (Cohen's  d  = -0.71).  Conclusion:  The authors conclude that the lower levels of anxiety reported following IET suggest that supervised exercise training is an effective coping strategy to deal with incarceration.  Trial registration:  ClinicalTrials.gov identifier: NCT04019171.",2020,showed a significantly greater reduction in anxiety than prisoners in the waiting-list.,"['Thirty-seven first-time prisoners with elevated anxiety symptoms completed the State-Trait Anxiety Inventory before and after a 6-week long treatment period consisting of', 'first-time prisoners with elevated anxiety symptoms']","['IET intervention', 'brief interval exercise training (IET) intervention', 'Exercise training', 'supervised exercise training', 'interval exercise training (IET;  n \u2009=\u200920) or no intervention (waiting-list;  n \u2009=\u200917']",['anxiety'],"[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}]",,0.0491,showed a significantly greater reduction in anxiety than prisoners in the waiting-list.,"[{'ForeName': 'Fabien D', 'Initials': 'FD', 'LastName': 'Legrand', 'Affiliation': 'Department of Psychology, C2S, EA 6291, Université de Reims Champagne Ardenne, Reims, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Ory', 'Affiliation': 'Department of Psychology, C2S, EA 6291, Université de Reims Champagne Ardenne, Reims, France.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Herring', 'Affiliation': 'Department of Physical Education and Sports Sciences, Health Research Institute, University of Limerick, Limerick, Ireland.'}]","Anxiety, stress, and coping",['10.1080/10615806.2020.1768244']
1065,31846169,Dentinal tubule penetration and root canal cleanliness following ultrasonic activation of intracanal-heated sodium hypochlorite.,"This study investigated the effect of ultrasonic activation of intracanal-heated sodium hypochlorite (NaOCl) on its dentinal tubular penetration and root canal cleanliness in vitro. In experiment 1, mandibular premolars were randomly allocated to three groups (n = 8): group A, ultrasonic activation; group B, ultrasonic activation of intracanal-heated NaOCl and group C, syringe-and-needle irrigation. Penetration of the fluorescent-labelled NaOCl was investigated using light microscopy. In experiment 2, mandibular premolars were randomly allocated to group B or C (n = 10), for histological analysis of the remaining pulp tissue and debris. Data were statistically analysed using Kruskal-Wallis and Mann-Whitney tests (P = 0.05). The highest penetration of NaOCl was observed in group B, followed by group A (P < 0.05). Group B showed significantly less amount of debris than group C (P < 0.05). Dentinal tubule penetration of NaOCl and root canal cleanliness were significantly improved by ultrasonic activation of intracanal-heated NaOCl.",2020,"The highest penetration of NaOCl was observed in group B, followed by group A (P < 0.05).",[],"['intracanal-heated sodium hypochlorite', 'C', 'ultrasonic activation of intracanal-heated sodium hypochlorite (NaOCl', 'ultrasonic activation; group B, ultrasonic activation of intracanal-heated NaOCl and group C, syringe-and-needle irrigation']","['Dentinal tubule penetration of NaOCl and root canal cleanliness', 'amount of debris', 'Kruskal-Wallis and Mann-Whitney tests', 'highest penetration of NaOCl']",[],"[{'cui': 'C0037518', 'cui_str': 'Sodium Hypochlorite'}, {'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0441837', 'cui_str': 'Group C (qualifier value)'}, {'cui': 'C0184957', 'cui_str': 'Irrigation with syringe (procedure)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}]","[{'cui': 'C0227017', 'cui_str': 'Dentinal tubules (body structure)'}, {'cui': 'C0086881', 'cui_str': 'Root Canal'}, {'cui': 'C0440266', 'cui_str': 'Debris (substance)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0188778,"The highest penetration of NaOCl was observed in group B, followed by group A (P < 0.05).","[{'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Iandolo', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Abdellatif', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, University of Alexandria, Alexandria, Egypt.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Amato', 'Affiliation': 'Department of Medicine and Surgery, University of Salerno, Salerno, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Blasi', 'Affiliation': 'Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Franco', 'Affiliation': 'Dentistry, Faculty of Medicine and Surgery, University of Siena, Siena, Italy.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Neelakantan', 'Affiliation': 'Discipline of Endodontology, Faculty of Dentistry, The University of Hong Kong, Hong Kong, Hong Kong.'}]",Australian endodontic journal : the journal of the Australian Society of Endodontology Inc,['10.1111/aej.12393']
1066,31462766,Reward related ventral striatal activity and differential response to sertraline versus placebo in depressed individuals.,"Medications to treat major depressive disorder (MDD) are not equally effective across patients. Given that neural response to rewards is altered in MDD and given that reward-related circuitry is modulated by dopamine and serotonin, we examined, for the first time, whether reward-related neural activity moderated response to sertraline, an antidepressant medication that targets these neurotransmitters. A total of 222 unmedicated adults with MDD randomized to receive sertraline (n = 110) or placebo (n = 112) in the Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study completed demographic and clinical assessments, and pretreatment functional magnetic resonance imaging while performing a reward task. We tested whether an index of reward system function in the ventral striatum (VS), a key reward circuitry region, moderated differential response to sertraline versus placebo, assessed with the Hamilton Rating Scale for Depression (HSRD) over 8 weeks. We observed a significant moderation effect of the reward index, reflecting the temporal dynamics of VS activity, on week-8 depression levels (Fs ≥ 9.67, ps ≤ 0.002). Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms. Thus, a more abnormal pattern of pretreatment VS dynamic response to reward expectancy (expected outcome value) and prediction error (difference between expected and actual outcome), likely reflecting serotonergic and dopaminergic deficits, was associated with better response to sertraline than placebo. Pretreatment measures of reward-related VS activity may serve as objective neural markers to advance efforts to personalize interventions by guiding individual-level choice of antidepressant treatment.",2020,"Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms.","['depressed individuals', '222 unmedicated adults with MDD randomized to receive']","['placebo (n\u2009=\u2009112) in the Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study completed demographic and clinical assessments, and pretreatment functional magnetic resonance imaging while performing a reward task', 'sertraline', 'placebo', 'sertraline versus placebo']","['Hamilton Rating Scale for Depression (HSRD', 'depression symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",222.0,0.129786,"Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms.","[{'ForeName': 'Tsafrir', 'Initials': 'T', 'LastName': 'Greenberg', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA. greenbergt@upmc.edu.'}, {'ForeName': 'Jay C', 'Initials': 'JC', 'LastName': 'Fournier', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Richelle', 'Initials': 'R', 'LastName': 'Stiffler', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Chase', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Almeida', 'Affiliation': 'Department of Psychiatry, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Aslam', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Marisa S', 'Initials': 'MS', 'LastName': 'Toups', 'Affiliation': 'Department of Psychiatry, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Carmody', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Benji', 'Initials': 'B', 'LastName': 'Kurian', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Peltier', 'Affiliation': 'Functional MRI Laboratory, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Oquendo', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Parsey', 'Affiliation': 'Departments of Psychiatry and Behavioral Science & Radiology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Weissman', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Madhukar', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Molecular psychiatry,['10.1038/s41380-019-0490-5']
1067,30803749,The Effects of OMEGA-3 Fatty Acid Supplementation Upon Interleukin-12 and Interleukin-18 in Chronic Kidney Disease Patients.,"OBJECTIVE(S)


Cardiovascular disease (CVD) remains a leading cause of mortality in chronic kidney disease (CKD) patients. Interventions targeting traditional risk factors have largely proven ineffective in CKD patients in part because of the increased role of nontraditional risk factors such as chronic inflammation. Omega-3 fatty acids (ω3FA) are inexpensive and safe natural agents, which target inflammation and have potential cardioprotective benefits. The aim of the study was to determine the effects of ω3FA supplementation upon serum interleukin (IL)-12, IL-18, and highly sensitive C-reactive protein (hsCRP) in patients with Stage 3-4 CKD.
METHODS


We performed a post-hoc analysis of a randomized placebo-controlled trial in 73 nondiabetic CKD patients to determine the effects of ω3FA supplementation (4 g daily for 8 weeks) upon serum levels of IL-12, IL-18, and hsCRP.
RESULTS


There were no preintervention differences in IL-12, IL-18, or hsCRP between treatment groups. Postintervention levels of IL-12, IL-18, and hsCRP were similar between the treatment groups. However, IL-12 and IL-18 increased in both treatment groups over the intervention period, whereas hsCRP remained unchanged. The magnitude of increase in serum IL-18 (ΔIL-18) was significantly less in participants in the ω3FA treatment group compared to placebo (P = .047).
CONCLUSION(S)


This study has shown that 4 g daily ω3FA supplementation may lower serum IL-18 levels in patients with moderate CKD. Although there were no apparent effects on several other markers of inflammation, this study provides evidence for a specific effect of ω3FA on inflammatory pathways.",2019,"The magnitude of increase in serum IL-18 (ΔIL-18) was significantly less in participants in the ω3FA treatment group compared to placebo (P = .047).
","['73 nondiabetic CKD patients', 'chronic kidney disease (CKD) patients', 'patients with Stage 3-4 CKD', 'Chronic Kidney Disease Patients', 'patients with moderate CKD']","['Omega-3 fatty acids (ω3FA', 'placebo', 'ω3FA supplementation', 'OMEGA-3 Fatty Acid Supplementation']","['serum levels of IL-12, IL-18, and hsCRP', 'IL-12, IL-18, or hsCRP', 'Postintervention levels of IL-12, IL-18, and hsCRP', 'IL-12 and IL-18', 'serum interleukin (IL)-12, IL-18, and highly sensitive C-reactive protein (hsCRP', 'serum IL-18 (ΔIL-18', 'serum IL-18 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C0439822', 'cui_str': 'Highly sensitive (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",73.0,0.165865,"The magnitude of increase in serum IL-18 (ΔIL-18) was significantly less in participants in the ω3FA treatment group compared to placebo (P = .047).
","[{'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Yong', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia; Department of Nephrology, Prince of Wales Hospital, Sydney, Australia. Electronic address: kyonga08@yahoo.com.au.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Mori', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Chew', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Beilin', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Puddey', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Gerald F', 'Initials': 'GF', 'LastName': 'Watts', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Irish', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Gursharan', 'Initials': 'G', 'LastName': 'Dogra', 'Affiliation': 'Department of Nephrology, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Boudville', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia; Department of Nephrology, Sir Charles Gairdner Hospital, Perth, Australia.'}, {'ForeName': 'Wai', 'Initials': 'W', 'LastName': 'Lim', 'Affiliation': 'Medical School, University of Western Australia, Perth, Australia; Department of Nephrology, Sir Charles Gairdner Hospital, Perth, Australia.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2019.01.001']
1068,31859226,Video Coaching Improving Contemporary Technical and Nontechnical Ability in Laparoscopic Education.,"OBJECTIVE


A video coaching (VC) system has been developed in surgical education. This study compares the educational effect on technical and nontechnical skills of the VC method for teaching laparoscopic surgery.
DESIGN


We conducted a prospectively randomized study of an education program to teach laparoscopic procedures.
SETTING


The study was performed at the Chang Gung Memorial Hospital, a university hospital in Taiwan.
PARTICIPANTS


We enrolled sixteen first- or second-year surgical residents.The participants were randomized into VC and conventional teaching (CT) groups, and their surgical skills were judged by the Global Operation Assessment of Laparoscopic Skills (GOALS) and the Objective Structured Assessment of Technical Skills (OSATS). Nontechnical skills were evaluated by the Non-Technical Skills for Surgeons (NOTSS) assessment and self-efficacy questionnaires (SEQs). After the program, posttraining scores were compared to assess improvements.
RESULTS


The 16 enrolled participants finished the entire course and completed all the videos during the study period. Comparing the VC and CT groups, we found that the pretraining GOALS, OSATS, NOTSS and SEQ scores were similar between both groups. However, after training, the OSATS score gain was higher in the VC groupthan in the CT group (9.25 ± 2.05 vs. 6.50 ± 1.51, p=0.009). Regarding nontechnical skills, the NOTSS score improved more in the VC group than in the CT group (5.50 ± 0.93 vs. 4.25 ± 0.89, p=0.015). The SEQ score was also higher in the VC group (32.13 ± 2.10) than in the CT group (29.50 ± 1.77), with a significant difference (p=0.018).
CONCLUSION


VC can help surgeons build their expertise using a more accessible method. Additionally, VC can shorten the learning curve and improve self-efficacy, thereby contributing to surgeons' education.",2020,"The SEQ score was also higher in the VC group (32.13 ± 2.10) than in the CT group (29.50 ± 1.77), with a significant difference (p=0.018).
","['We enrolled sixteen first- or second-year surgical residents', 'The study was performed at the Chang Gung Memorial Hospital, a university hospital in Taiwan', '16 enrolled participants finished the entire course and completed all the videos during the study period']","['video coaching (VC) system', 'Video Coaching', 'education program to teach laparoscopic procedures', 'VC and conventional teaching (CT) groups, and their surgical skills were judged by the Global Operation Assessment of Laparoscopic Skills (GOALS) and the Objective Structured Assessment of Technical Skills (OSATS']","['pretraining GOALS, OSATS, NOTSS and SEQ scores', 'Nontechnical skills', 'learning curve and improve self-efficacy', 'OSATS score gain', 'NOTSS score', 'SEQ score', 'Non-Technical Skills for Surgeons (NOTSS) assessment and self-efficacy questionnaires (SEQs']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0521291', 'cui_str': 'Laparoscopic-assisted procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2936637', 'cui_str': 'Learning Curve'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0294424,"The SEQ score was also higher in the VC group (32.13 ± 2.10) than in the CT group (29.50 ± 1.77), with a significant difference (p=0.018).
","[{'ForeName': 'Chien-Hung', 'Initials': 'CH', 'LastName': 'Liao', 'Affiliation': 'Department of Traumatology and Emergency Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Chun-Hsiang', 'Initials': 'CH', 'LastName': 'Ooyang', 'Affiliation': 'Department of Traumatology and Emergency Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Chih-Chi', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Department of Physical medicine and Rehabilitation, Chang Gung Memorial Hospital, Chang Gung University, Linkou, Taoyuan Taiwan.'}, {'ForeName': 'Chien-An', 'Initials': 'CA', 'LastName': 'Liao', 'Affiliation': 'Department of Traumatology and Emergency Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Chi-Tung', 'Initials': 'CT', 'LastName': 'Cheng', 'Affiliation': 'Department of Traumatology and Emergency Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Ming-Ju', 'Initials': 'MJ', 'LastName': 'Hsieh', 'Affiliation': 'Department of Cardiovascular and thoracic Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Chi-Hsun', 'Initials': 'CH', 'LastName': 'Hsieh', 'Affiliation': 'Department of Traumatology and Emergency Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Chun-Yi', 'Initials': 'CY', 'LastName': 'Tsai', 'Affiliation': 'Department of General Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Ta-Sen', 'Initials': 'TS', 'LastName': 'Yeh', 'Affiliation': 'Department of General Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Chun-Nan', 'Initials': 'CN', 'LastName': 'Yeh', 'Affiliation': 'Department of General Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Chih-Yuan', 'Initials': 'CY', 'LastName': 'Fu', 'Affiliation': 'Department of Traumatology and Emergency Surgery, Chang Gung Memorial Hospital, Chang Gung University, Taoyuan, Taiwan. Electronic address: surgymet@gmail.com.'}]",Journal of surgical education,['10.1016/j.jsurg.2019.11.012']
1069,31950378,Fracture strength of endodontically treated teeth restored with different fiber post and core systems.,"The aim of this study was to investigate the effects of different post and core systems, CAD/CAM crown placement on fracture strength of endodontically treated mandibular premolar teeth. One hundred forty single-rooted premolar teeth were randomly divided into a control group and six experimental groups as follows: control group (Group 1); FiberSite post luting with Clearfil DC Core Plus (Group 2); RelyX Fiber post luting and core build up with Clearfil DC Core Plus (Group 3); RelyX Fiber post luting with Clearfil DC Core Plus and core build up with Filtek Bulk Fill Posterior (Group 4); specimens that received CAD/CAM crowns after the same procedures performed in Groups 2, 3, and 4, respectively (Groups 5, 6, and 7). Fracture strength tests were performed, and the failure modes were recorded. Data were statistically analyzed using one-way ANOVA and post hoc Tukey tests. The highest fracture resistance was observed in the control group and among the experimental groups in Group 4. Groups 3 and 5 showed similar fracture resistance followed by Group 2. The lowest fracture resistances were seen in the samples of Groups 6 and 7. While the fracture strength of Group 2 increased after the crown placement (Group 5), the fracture strength of Group 3 and Group 4 decreased (P < 0.05). While the specimens in Groups 1, 2, 3, and 4 predominantly showed favorable failure, unfavorable failure was more frequent in Groups 5, 6, and 7.",2020,"While the fracture strength of Group 2 increased after the crown placement (Group 5), the fracture strength of Group 3 and Group 4 decreased (P < 0.05).","['endodontically treated mandibular premolar teeth', 'One hundred forty single-rooted premolar teeth']","['CAD/CAM crown placement', 'FiberSite post luting with Clearfil DC Core Plus (Group 2); RelyX Fiber post luting and core build up with Clearfil DC Core Plus (Group 3); RelyX Fiber post luting with Clearfil DC Core Plus and core build up with Filtek Bulk Fill Posterior (Group 4); specimens that received CAD/CAM crowns']","['Fracture strength', 'Fracture strength tests', 'fracture resistance', 'favorable failure, unfavorable failure', 'highest fracture resistance', 'lowest fracture resistances', 'fracture strength']","[{'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}]","[{'cui': 'C3853546', 'cui_str': 'Dental Crowns'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C4505780', 'cui_str': 'Filtek Bulk Fill'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}]","[{'cui': 'C4704755', 'cui_str': 'Flexural Properties'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",140.0,0.0169532,"While the fracture strength of Group 2 increased after the crown placement (Group 5), the fracture strength of Group 3 and Group 4 decreased (P < 0.05).","[{'ForeName': 'Taha', 'Initials': 'T', 'LastName': 'Özyürek', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Medeniyet University, Istanbul, Turkey.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Topkara', 'Affiliation': 'Private Practice, Samsun, Turkey.'}, {'ForeName': 'İmran', 'Initials': 'İ', 'LastName': 'Koçak', 'Affiliation': 'Oral and Dental Health Center, Osmaniye, Turkey.'}, {'ForeName': 'Koray', 'Initials': 'K', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Mustafa Kemal University, Hatay, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Gündoğar', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Gülşah', 'Initials': 'G', 'LastName': 'Uslu', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Onsekiz Mart University, Çanakkale, Turkey. gulsah.turkkan@hotmail.com.'}]",Odontology,['10.1007/s10266-020-00481-4']
1070,32439860,A randomized trial evaluating virus-specific effects of a combination probiotic in children with acute gastroenteritis.,"Gastroenteritis accounts for nearly 500,000 deaths in children younger than 5 years annually. Although probiotics have been touted as having the potential to expedite diarrhea resolution, recent clinical trials question their effectiveness. A potential explanation is a shift in pathogens following the introduction of a rotavirus vaccine. Here, we report the results of a multi-center, double-blind trial of 816 children with acute gastroenteritis who completed follow-up and provided multiple stool specimens. Participants were randomized to receive a probiotic containing Lactobacillus rhamnosus and Lactobacillus helveticus or placebo. We report no virus-specific beneficial effects attributable to the probiotic, either in reducing clinical symptoms or viral nucleic acid clearance from stool specimens collected up to 28 days following enrollment. We provide pathophysiological and microbiologic evidence to support the clinical findings and conclude that our data do not support routine probiotic administration to children with acute gastroenteritis, regardless of the infecting virus.",2020,"We report no virus-specific beneficial effects attributable to the probiotic, either in reducing clinical symptoms or viral nucleic acid clearance from stool specimens collected up to 28 days following enrollment.","['children younger than 5 years annually', '816 children with acute gastroenteritis who completed follow-up and provided multiple stool specimens', 'children with acute gastroenteritis']","['combination probiotic', 'probiotic containing Lactobacillus rhamnosus and Lactobacillus helveticus or placebo']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0317592', 'cui_str': 'Lactobacillus helveticus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],816.0,0.233591,"We report no virus-specific beneficial effects attributable to the probiotic, either in reducing clinical symptoms or viral nucleic acid clearance from stool specimens collected up to 28 days following enrollment.","[{'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Freedman', 'Affiliation': ""Alberta Children's Hospital Foundation Professor in Child Health and Wellness, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, 28 Oki Drive NW, Calgary, AB, T3B 6A8, Canada. Stephen.freedman@ahs.ca.""}, {'ForeName': 'Jianling', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ""Alberta Children's Hospital Foundation Professor in Child Health and Wellness, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, 28 Oki Drive NW, Calgary, AB, T3B 6A8, Canada.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Nettel-Aguirre', 'Affiliation': ""Alberta Children's Hospital Foundation Professor in Child Health and Wellness, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, 28 Oki Drive NW, Calgary, AB, T3B 6A8, Canada.""}, {'ForeName': 'Xiao-Li', 'Initials': 'XL', 'LastName': 'Pang', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Chui', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Williamson-Urquhart', 'Affiliation': ""Alberta Children's Hospital Foundation Professor in Child Health and Wellness, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, 28 Oki Drive NW, Calgary, AB, T3B 6A8, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schnadower', 'Affiliation': 'University of Cincinnati, 3333 Burnet Ave, Cincinnati, OH, UCA 45229, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Schuh', 'Affiliation': 'University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Sherman', 'Affiliation': 'University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': 'Bonita E', 'Initials': 'BE', 'LastName': 'Lee', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Gouin', 'Affiliation': 'Université de Montréal, 3175 Chemin de la Côte-Sainte-Catherine, Montréal, QC, H3T 1C5, Canada.'}, {'ForeName': 'Ken J', 'Initials': 'KJ', 'LastName': 'Farion', 'Affiliation': 'University of Ottawa, 401 Smyth Rd, Ottawa, ON, K1H 8L1, Canada.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Poonai', 'Affiliation': 'University of Western Ontario, 800 Commissioners Road E, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'Katrina F', 'Initials': 'KF', 'LastName': 'Hurley', 'Affiliation': 'Dalhousie University, 5980 University Avenue, PO Box 9700, Halifax, NS, B3K 6R8, Canada.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Qiu', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Binal', 'Initials': 'B', 'LastName': 'Ghandi', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Lloyd', 'Affiliation': 'University of Alberta, 116 St & 85 Ave., Edmonton, AB, T6G 2R3, Canada.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Finkelstein', 'Affiliation': 'University of Toronto, 555 University Avenue, Toronto, ON, M5G 1X8, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Nature communications,['10.1038/s41467-020-16308-3']
1071,31334914,Renal denervation in patients with heart failure secondary to Chagas' disease: A pilot randomized controlled trial.,"INTRODUCTION


Chagas disease is one of the most relevant endemic parasitic diseases in Latin America, affecting approximately 6 million people. Overt Chagas heart disease is an ominous condition, occurring in 20-30% of infected individuals, which has besides the persistent myocarditis a peculiar intracardiac ganglionic neuronal depletion and dysautonomy. This study aims to evaluate the safety and feasibility of renal denervation for patients with advanced symptomatic Chagas cardiomyopathy.
METHODS


Open-label prospective pilot study that randomized patients with Chagas heart disease to either renal denervation or conservative treatment (2:1 ratio). The primary endpoint was the incidence of major adverse events at 9 months, defined as a composite of all-cause death, myocardial infarction, stroke, need for renal artery invasive treatment, or worsening renal function.
RESULTS


A total of 17 patients were allocated for renal denervation (n = 11) or conservative treatment (n = 6). Included patients had severe symptomatic heart disease, with markedly depressed left ventricular function (average ejection fraction 26.7 ± 4.9%). For patients randomized to renal denervation, the procedure was performed successfully and uneventfully. After 9 months, the primary endpoint occurred in 36.4% of patients in the renal denervation group and 50.0% in the control arm (p = .6). After 9 months, clinical, laboratory, functional, echocardiographic, and quality of life parameters were similar between groups.
CONCLUSIONS


This pilot study suggests that renal denervation is safe and feasible in patients with Chagas cardiomyopathy, warranting future studies to better evaluate the clinical efficacy of the interventional strategy in improving the prognosis of this high-risk population.",2019,"After 9 months, the primary endpoint occurred in 36.4% of patients in the renal denervation group and 50.0% in the control arm (p = .6).","['randomized patients with Chagas heart disease to either renal denervation or conservative treatment (2:1 ratio', '17 patients were allocated for renal denervation (n = 11) or', 'Included patients had severe symptomatic heart disease, with markedly depressed left ventricular function (average ejection fraction 26.7\u2009±\u20094.9', 'patients with Chagas cardiomyopathy', ""patients with heart failure secondary to Chagas' disease"", 'patients with advanced symptomatic Chagas cardiomyopathy']","['conservative treatment', 'renal denervation']","['clinical, laboratory, functional, echocardiographic, and quality of life parameters', 'incidence of major adverse events at 9 months, defined as a composite of all-cause death, myocardial infarction, stroke, need for renal artery invasive treatment, or worsening renal function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0007930', 'cui_str': 'Trypanosomiasis, Cardiovascular'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0041234', 'cui_str': 'Trypanosoma cruzi Infection'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C1321798', 'cui_str': 'Muscle denervation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0035065', 'cui_str': 'Renal Artery'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}]",,0.0622165,"After 9 months, the primary endpoint occurred in 36.4% of patients in the renal denervation group and 50.0% in the control arm (p = .6).","[{'ForeName': 'André G', 'Initials': 'AG', 'LastName': 'Spadaro', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Edimar A', 'Initials': 'EA', 'LastName': 'Bocchi', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Germano E', 'Initials': 'GE', 'LastName': 'Souza', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Antonio E', 'Initials': 'AE', 'LastName': 'Filho', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Mariani', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Campos', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Lemos', 'Affiliation': 'Heart Institute (InCor), University of São Paulo Medical School, São Paulo, São Paulo, Brazil.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28393']
1072,29746713,"Lack of Impact by SCY-078, a First-in-Class Oral Fungicidal Glucan Synthase Inhibitor, on the Pharmacokinetics of Rosiglitazone, a Substrate for CYP450 2C8, Supports the Low Risk for Clinically Relevant Metabolic Drug-Drug Interactions.","SCY-078, the first in a new class of β 1,3-glucan synthesis inhibitors, is being developed as an oral and intravenous antifungal treatment for Candida and Aspergillus species fungal infections. In vitro, studies indicated SCY-078 is an inhibitor of cytochrome P450 (CYP) 2C8 with markedly lower effect over other CYP isozymes. To examine clinically relevant effects of the potential interaction with SCY-078, this phase 1, open-label, 2-period crossover study evaluated the pharmacokinetic parameters of rosiglitazone, a sensitive substrate of CYP2C8 metabolism, in the absence and presence of SCY-078 dosed to therapeutically relevant SCY-078 concentration exposure after repeat dosing. Healthy adult subjects were randomized to 2 treatment sequences: a single oral 4-mg rosiglitazone dose alone on day 1 or a 1250-mg SCY-078 loading dose on day 1 followed by a once-daily 750-mg SCY-078 dose for an additional 7 days (reflecting the clinical regimen evaluated during phase 2 studies for infections by Candida species) and concurrent administration of a single oral 4-mg rosiglitazone dose on day 3, before alternating following a ≥10-day washout. The exposure to SCY-078 observed in this study was in line with the intended exposure for treatment of invasive fungal infections. The 90% confidence intervals for rosiglitazone exposure geometric mean ratios were within the prespecified no effect interval of 0.70-1.43. Additionally, maximum concentration values for rosiglitazone and its metabolite, N-desmethylrosiglitazone, were not significantly affected by co-administration with SCY-078. Overall, rosiglitazone exposure was not impacted to a clinically meaningful extent with co-administration of therapeutically relevant SCY-078 concentration exposure after repeat dosing. The results are indicative of low risk for interaction of SCY-078 with drugs metabolized via the CYP family of enzymes.",2018,The results are indicative of low risk for interaction of SCY-078 with drugs metabolized via the CYP family of enzymes.,['Healthy adult subjects'],"['single oral 4-mg rosiglitazone', 'rosiglitazone', 'Rosiglitazone']","['rosiglitazone exposure geometric mean ratios', 'maximum concentration values']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0289313', 'cui_str': 'rosiglitazone'}]","[{'cui': 'C0289313', 'cui_str': 'rosiglitazone'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0292679,The results are indicative of low risk for interaction of SCY-078 with drugs metabolized via the CYP family of enzymes.,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Wring', 'Affiliation': 'SCYNEXIS, Inc., NJ, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Murphy', 'Affiliation': 'Riverside Consulting, DE, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Atiee', 'Affiliation': 'Worldwide Clinical Trials, TX, USA.'}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Corr', 'Affiliation': 'BCH Research Solutions, PA, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Hyman', 'Affiliation': 'BCH Research Solutions, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Willett', 'Affiliation': 'Ready Clinical, NJ, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Angulo', 'Affiliation': 'SCYNEXIS, Inc., NJ, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1146']
1073,31448867,Procedural and clinical performance of dual- versus single-catheter strategy for transradial coronary angiography: A meta-analysis of randomized trials.,"OBJECTIVES


We sought to compare the procedural and clinical performance of dual- versus single-catheter strategy for transradial coronary angiography.
BACKGROUND


The radial artery (RA) is recommended as the vascular access of choice in patients undergoing coronary angiography and intervention. The procedural and clinical performance of dual- versus single-catheter strategy in patients undergoing transradial coronary angiography remains a matter of debate.
METHODS


This is a study-level meta-analysis of randomized trials. The primary outcome was procedure time. The main secondary outcome was fluoroscopy time. Other outcomes of interest were contrast volume, crossover to other catheter strategy and RA spasm.
RESULTS


A total of 2,062 patients (978 randomly assigned to dual-catheter and 1,084 to single-catheter strategy) included in seven trials were available for the quantitative synthesis. A dual-catheter strategy was associated with procedure time (standardized mean difference [95% confidence intervals (CI)], 0.55 [-0.69, 1.78]; p = .32), fluoroscopy time (-0.36 [-2.39, 1.67]; p = .68) and contrast volume (-0.93 [-3.79, 1.94]; p = .44) comparable to a single-catheter strategy. The risk for crossover was lower (risk ratio [95% CI], 0.14 [0.03, 0.70]; p = .025) while the risk for RA spasm was higher (1.81 [1.54, 2.12]; p < .001) among patients assigned to dual- versus single-catheter strategy.
CONCLUSIONS


This meta-analysis provides evidence for a comparable procedural performance of either dual- or single-catheter strategy for transradial coronary angiography. The fewer crossovers with dual-catheter strategy occur at the expense of more frequent radial artery spasm.",2020,"p = .025) while the risk for RA spasm was higher (1.81 [1.54, 2.12];","['2,062 patients (978 randomly assigned to', 'patients undergoing transradial coronary angiography remains a matter of debate', 'patients undergoing coronary angiography and intervention']","['dual- versus single-catheter strategy', 'dual-catheter and 1,084 to single-catheter strategy', 'transradial coronary angiography']","['risk for RA spasm', 'procedure time', 'fluoroscopy time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0037763', 'cui_str': 'Muscular Spasm'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}]",2062.0,0.304113,"p = .025) while the risk for RA spasm was higher (1.81 [1.54, 2.12];","[{'ForeName': 'Brunilda', 'Initials': 'B', 'LastName': 'Alushi', 'Affiliation': 'Department of Cardiology, University Heart Center Berlin and Charite University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lauten', 'Affiliation': 'Department of Cardiology, University Heart Center Berlin and Charite University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Gjin', 'Initials': 'G', 'LastName': 'Ndrepepa', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Leistner', 'Affiliation': 'Department of Cardiology, University Heart Center Berlin and Charite University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Kufner', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Erion', 'Initials': 'E', 'LastName': 'Xhepa', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'Department of Cardiology, University Heart Center Berlin and Charite University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Kastrati', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cassese', 'Affiliation': 'Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28458']
1074,30709714,Sociodemographic and Kidney Disease Correlates of Nutrient Intakes Among Urban African Americans With Uncontrolled Hypertension.,"OBJECTIVE


The objective of this study was to determine the association between sociodemographic factors and intakes of 4 nutrients and associations between intakes and markers of kidney disease to identify opportunities to improve outcomes among clinically high-risk African Americans.
DESIGN AND METHODS


We conducted a cross-sectional study of baseline data from the Achieving Blood Pressure Control Together study, a randomized controlled trial of 159 African Americans (117 females) with uncontrolled hypertension in Baltimore MD. To determine the association between sociodemographic factors and nutrient intakes, we constructed linear and logistic regression models. Using logistic regression, we determined the association between below-median nutrient intakes and kidney disease. Our outcomes of interest were daily intakes of vitamin C, magnesium, dietary fiber, and potassium as estimated by the Block Fruit-Vegetable-Fiber Screener and kidney disease defined as estimated glomerular filtration rate <60 mL/min per 1.73 m2 or urinary albumin-to-creatinine ratio >=30 mg/g.
SETTING AND SUBJECTS


Baseline data from the Achieving Blood Pressure Control Together study, a randomized controlled trial of 159 African Americans (117 females) with uncontrolled hypertension, were obtained.
METHODS


To determine the association between sociodemographic factors and nutrient intakes, we constructed linear and logistic regression models. Using logistic regression, we determined the association between below-median nutrient intakes and kidney disease.
MAIN OUTCOME MEASURES


Our outcomes of interest were daily intakes of vitamin C, magnesium, dietary fiber, and potassium as estimated by the Block Fruit-Vegetable-Fiber Screener and kidney disease defined as estimated glomerular filtration rate <60 mL/min per 1.73 m 2  or urinary albumin-to-creatinine ratio ≥30 mg/g.
RESULTS


Overall, compared to Institute of Medicine recommendations, participants had lower intakes of magnesium, fiber, and potassium but higher vitamin C intakes. For females, sociodemographic factors that significantly associated with lower intake of the 4 nutrients were older age, obesity, lower health numeracy, and lesser educational attainment. For males, none of the sociodemographic factors were significantly associated with nutrient intakes. Below-median intake was significantly associated with albumin-to-creatinine ratio ≥30 (adjusted odds ratio [95% confidence interval]: 3.4 [1.5, 7.8] for vitamin C; 3.6 [1.6, 8.4] for magnesium; 2.9 [1.3, 6.5] for fiber; 3.6 [1.6, 8.4] for potassium), but not with estimated glomerular filtration rate <60.
CONCLUSION


African Americans with uncontrolled hypertension may have low intakes of important nutrients, which could increase their risk of chronic kidney disease. Tailored dietary interventions for African Americans at high risk for chronic kidney disease may be warranted.",2019,"Overall, compared to Institute of Medicine recommendations, participants had lower intakes of magnesium, fiber, and potassium but higher vitamin C intakes.","['159 African Americans (117 females) with uncontrolled hypertension, were obtained', '159 African Americans (117 females) with uncontrolled hypertension in Baltimore MD', 'African Americans at high risk for chronic kidney disease', 'clinically high-risk African Americans', 'Urban African Americans With Uncontrolled Hypertension', 'African Americans with uncontrolled hypertension']","['Tailored dietary interventions', 'vitamin C, magnesium, dietary fiber, and potassium']","['Blood Pressure Control', 'Sociodemographic and Kidney Disease Correlates of Nutrient Intakes']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",159.0,0.057857,"Overall, compared to Institute of Medicine recommendations, participants had lower intakes of magnesium, fiber, and potassium but higher vitamin C intakes.","[{'ForeName': 'Annie Y', 'Initials': 'AY', 'LastName': 'Song', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Deidra C', 'Initials': 'DC', 'LastName': 'Crews', 'Affiliation': 'Division of Nephrology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland; Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, Maryland; Johns Hopkins Center for Health Equity, Johns Hopkins Medical Institutions, Baltimore, Maryland. Electronic address: dcrews1@jhmi.edu.'}, {'ForeName': 'Patti L', 'Initials': 'PL', 'LastName': 'Ephraim', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, Maryland; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Dingfen', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Raquel C', 'Initials': 'RC', 'LastName': 'Greer', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, Maryland; Johns Hopkins Center for Health Equity, Johns Hopkins Medical Institutions, Baltimore, Maryland; Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'LaPricia Lewis', 'Initials': 'LL', 'LastName': 'Boyér', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ameling', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan.'}, {'ForeName': 'Debra J', 'Initials': 'DJ', 'LastName': 'Gayles', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Sneed', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, Maryland; Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Carson', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, Maryland; Johns Hopkins Center for Health Equity, Johns Hopkins Medical Institutions, Baltimore, Maryland; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Albert', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, Maryland.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cooper', 'Affiliation': 'Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Medical Institutions, Baltimore, Maryland; Johns Hopkins Center for Health Equity, Johns Hopkins Medical Institutions, Baltimore, Maryland; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; Division of General Internal Medicine, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'L Ebony', 'Initials': 'LE', 'LastName': 'Boulware', 'Affiliation': 'Division of General Internal Medicine, Duke University School of Medicine, Durham, North Carolina.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2018.12.004']
1075,31490817,Effect of Different Concentrations of Propofol Used as a Sole Anesthetic on Pupillary Diameter: A Randomized Trial.,"BACKGROUND


Pupillometry monitoring under general anesthesia is based on the assumption that pupillary diameter variations reflect the adequacy of the provided analgesia to the intensity of the nociceptive surgical stimulus. The accurate interpretation of pupillometric data requires establishing clearly what the expected baseline unstimulated pupillary diameter at each specific level of hypnosis is. Opioids decrease pupillary diameter in a dose-dependent fashion. In contrast, the effects of hypnotic drugs on pupillary diameter are not well known. Our aim was to describe the potential relationship between propofol predicted effect-site concentrations (Cets) ranging from 1 to 3 µg/mL and pupillary diameter.
METHODS


Patients were randomized to receive propofol by target-controlled infusion at a predicted Cet of 1, 2, or 3 µg/mL (groups P1, P2, and P3, respectively). Pupillary diameter measurements were performed after 10 minutes of steady-state propofol infusion at the randomized Cet. No stimulation was performed during the study. Heart rate and bispectral index (BIS) were continuously recorded.
RESULTS


Forty patients were included: (13, 14, and 13 in groups P1, P2, and P3, respectively). Mean pupillary diameter was 5.7 mm (1 mm) in group P1, 4.8 mm (1.3 mm) in group P2, and 3.3 mm (0.8 mm) in group P3. Propofol had a dose-dependent effect on pupillary diameter (linear regression R = 0.45, P < .001). Pupillary diameter was positively correlated with the BIS (Spearman r = 0.75 [95% confidence interval (CI), 0.54 to -0.87] P < .001).
CONCLUSIONS


From 1 to 3 µg/mL of predicted Cet, propofol has a dose-dependent effect on pupillary diameter. Within this concentrations range, there is a positive correlation between BIS and pupillary diameter. The subcortical effect of propofol on pupillary diameter is correlated to its effect on the cortex. Studies assessing pupillary diameter as a marker of the nociception-antinociception balance should be performed in patients with a standardized depth of hypnosis.",2020,"Mean pupillary diameter was 5.7 mm (1 mm) in group P1, 4.8 mm (1.3 mm) in group P2, and 3.3 mm (0.8 mm) in group P3.","['Patients', 'patients with a standardized depth of hypnosis']","['propofol', 'Propofol']","['Mean pupillary diameter', 'Opioids decrease pupillary diameter', 'pupillary diameter', 'Pupillary diameter measurements', 'Pupillary diameter', 'Heart rate and bispectral index (BIS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C3888013', 'cui_str': 'Hypnotism'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}]",40.0,0.0349464,"Mean pupillary diameter was 5.7 mm (1 mm) in group P1, 4.8 mm (1.3 mm) in group P2, and 3.3 mm (0.8 mm) in group P3.","[{'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Sabourdin', 'Affiliation': ""From the Département d'anesthesiologie, Hôpital Armand Trousseau, Paris, France.""}, {'ForeName': 'Fleur', 'Initials': 'F', 'LastName': 'Meniolle', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Chemam', 'Affiliation': ''}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Rigouzzo', 'Affiliation': ''}, {'ForeName': 'Jamil', 'Initials': 'J', 'LastName': 'Hamza', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Louvet', 'Affiliation': ''}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Constant', 'Affiliation': ''}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004362']
1076,31935026,Effect of a Behavioral Intervention to Increase Vegetable Consumption on Cancer Progression Among Men With Early-Stage Prostate Cancer: The MEAL Randomized Clinical Trial.,"Importance


Guidelines endorsing vegetable-enriched diets to improve outcomes for prostate cancer survivors are based on expert opinion, preclinical studies, and observational data.
Objective


To determine the effect of a behavioral intervention that increased vegetable intake on cancer progression in men with early-stage prostate cancer.
Design, Setting, and Participants


The Men's Eating and Living (MEAL) Study (CALGB 70807 [Alliance]) was a randomized clinical trial conducted at 91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group = 1 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level less than 10 ng/mL. Enrollment occurred from January 2011 to August 2015; 24-month follow-up occurred from January 2013 to August 2017.
Interventions


Patients were randomized to a counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n = 237) or a control group, which received written information about diet and prostate cancer (n = 241).
Main Outcomes and Measures


The primary outcome was time to progression; progression was defined as PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade) on follow-up prostate biopsy.
Results


Among 478 patients randomized (mean [SD] age, 64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis. There were 245 progression events (intervention: 124; control: 121). There were no significant differences in time to progression (unadjusted hazards ratio, 0.96 [95% CI, 0.75 to 1.24]; adjusted hazard ratio, 0.97 [95% CI, 0.76 to 1.25]). The 24-month Kaplan-Meier progression-free percentages were 43.5% [95% CI, 36.5% to 50.6%] and 41.4% [95% CI, 34.3% to 48.7%] for the intervention and control groups, respectively (difference, 2.1% [95% CI, -8.1% to 12.2%]).
Conclusions and Relevance


Among men with early-stage prostate cancer managed with active surveillance, a behavioral intervention that increased vegetable consumption did not significantly reduce the risk of prostate cancer progression. The findings do not support use of this intervention to decrease prostate cancer progression in this population, although the study may have been underpowered to identify a clinically important difference.
Trial Registration


ClinicalTrials.gov Identifier: NCT01238172.",2020,"There were no significant differences in time to progression (unadjusted hazards ratio, 0.96","['Men', '64 [7] years; mean [SD] PSA level, 4.9 [2.1] ng/mL), 443 eligible patients (93%) were included in the primary analysis', 'men with early-stage prostate cancer', 'men with early-stage prostate cancer managed with active surveillance', ""Participants\n\n\nThe Men's Eating and Living (MEAL) Study (CALGB 70807"", 'With Early-Stage Prostate Cancer', '478 patients randomized (mean [SD] age', '91 US urology and medical oncology clinics that enrolled 478 men aged 50 to 80 years with biopsy-proven prostate adenocarcinoma (International Society of Urological Pathology grade group\u2009=\u20091 in those <70 years and ≤2 in those ≥70 years), stage cT2a or less, and serum prostate-specific antigen (PSA) level', 'prostate cancer survivors']","['Guidelines endorsing vegetable-enriched diets', 'counseling behavioral intervention by telephone promoting consumption of 7 or more daily vegetable servings (MEAL intervention; n\u2009=\u2009237) or a control group, which received written information about diet and prostate cancer (n\u2009=\u2009241', 'behavioral intervention that increased vegetable intake', 'Behavioral Intervention to Increase Vegetable Consumption']","['time to progression; progression', 'Cancer Progression', 'PSA level of 10 ng/mL or greater, PSA doubling time of less than 3 years, or upgrading (defined as increase in tumor volume or grade', 'cancer progression', '24-month Kaplan-Meier progression-free percentages', 'time to progression', 'risk of prostate cancer progression', 'prostate cancer progression']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0025098', 'cui_str': 'Medical Oncology'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake (observable entity)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",478.0,0.259409,"There were no significant differences in time to progression (unadjusted hazards ratio, 0.96","[{'ForeName': 'J Kellogg', 'Initials': 'JK', 'LastName': 'Parsons', 'Affiliation': 'Department of Urology, UC San Diego Moores Comprehensive Cancer Center and VA San Diego Healthcare System, La Jolla, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zahrieh', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Mohler', 'Affiliation': 'Department of Urology, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}, {'ForeName': 'Electra', 'Initials': 'E', 'LastName': 'Paskett', 'Affiliation': 'Comprehensive Cancer Center, Department of Medicine, The Ohio State University College of Medicine, Columbus.'}, {'ForeName': 'Donna E', 'Initials': 'DE', 'LastName': 'Hansel', 'Affiliation': 'Department of Pathology, University of California, San Diego, La Jolla.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Kibel', 'Affiliation': ""Division of Urology, Dana-Farber/Brigham and Women's Cancer Center, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Heshan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Drew K', 'Initials': 'DK', 'LastName': 'Seisler', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Loki', 'Initials': 'L', 'LastName': 'Natarajan', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health and UC San Diego Moores Comprehensive Cancer Center, La Jolla, California.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'White', 'Affiliation': 'Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health and UC San Diego Moores Comprehensive Cancer Center, La Jolla, California.'}, {'ForeName': 'Olwen', 'Initials': 'O', 'LastName': 'Hahn', 'Affiliation': 'Alliance Central Protocol Operations, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Alliance Central Protocol Operations, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Moores Cancer Center, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Stroup', 'Affiliation': 'Department of Urology, Naval Medical Center San Diego, San Diego, California.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Van Veldhuizen', 'Affiliation': 'Menorah Medical Center, Midwest Oncology Associates, Overland Park, Kansas.'}, {'ForeName': 'Lannis', 'Initials': 'L', 'LastName': 'Hall', 'Affiliation': 'Siteman Cancer Center, Department of Radiation Oncology, Washington University, St Peters, Missouri.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Pierce', 'Affiliation': 'Moores Cancer Center, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'Department of Prevention and Population Sciences, Roswell Park Comprehensive Cancer Center, Buffalo, New York.'}]",JAMA,['10.1001/jama.2019.20207']
1077,31471180,Hemostatic and Anti-Inflammatory Effects of Carbazochrome Sodium Sulfonate in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial.,"BACKGROUND


Postoperative recovery after total knee arthroplasty (TKA) is associated with postoperative anemia, allogeneic transfusion, and stress immune responses to surgery. Carbazochrome sodium sulfonate (CSS) reduces bleeding through several mechanisms. We assessed the effect of CSS combined with tranexamic acid (TXA) on postoperative anemia, blood transfusion, and inflammatory responses.
METHODS


This study was designed as a randomized, placebo-controlled trial of 200 patients undergoing unilateral primary TKA. Patients were divided into 4 groups: group A received TXA plus topical and intravenous CSS; group B received TXA plus topical CSS only; group C received TXA plus intravenous CSS only; group D received TXA only.
RESULTS


Total blood loss in groups A (609.92 ± 221.24 mL), B (753.16 ± 247.67 mL), and C (829.23 ± 297.45 mL) was lower than in group D (1158.26 ± 334.13 mL, P < .05). There was no difference in total blood loss between groups B and C. We also found that compared with group D, the postoperative swelling rate, biomarker level of inflammation, visual analog scale pain score, and range of motion at discharge in groups A, B, and C were significantly improved (P < .05). No thromboembolic complications occurred. There were no differences in transfusion rate, intraoperative blood loss, platelet count, or average length of stay among the 4 groups (P > .05).
CONCLUSION


CSS combined with TXA was more effective than TXA alone in reducing perioperative blood loss and inflammatory response and did not increase the incidence of thromboembolism complications.",2020,"There were no differences in transfusion rate, intraoperative blood loss, platelet count, or average length of stay among the 4 groups (P > .05).
","['200 patients undergoing unilateral primary TKA', 'Patients Undergoing Total Knee Arthroplasty']","['CSS combined with tranexamic acid (TXA', 'Carbazochrome sodium sulfonate (CSS', 'placebo', 'TXA plus topical and intravenous CSS', 'total knee arthroplasty (TKA', 'Carbazochrome Sodium Sulfonate', 'TXA plus topical CSS', 'TXA only', 'TXA', 'TXA plus intravenous CSS']","['postoperative swelling rate, biomarker level of inflammation, visual analog scale pain score, and range of motion at discharge', 'postoperative anemia, blood transfusion, and inflammatory responses', 'thromboembolic complications', 'total blood loss', 'perioperative blood loss and inflammatory response', 'incidence of thromboembolism complications', 'Total blood loss', 'transfusion rate, intraoperative blood loss, platelet count, or average length of stay']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0054657', 'cui_str': 'carbazochrome sodium sulfonate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C3871203', 'cui_str': 'At discharge (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0232100', 'cui_str': 'Exsanguinating Hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",200.0,0.155413,"There were no differences in transfusion rate, intraoperative blood loss, platelet count, or average length of stay among the 4 groups (P > .05).
","[{'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Yeersheng', 'Initials': 'Y', 'LastName': 'Releken', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Zhouyuan', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.""}, {'ForeName': 'FuXing', 'Initials': 'F', 'LastName': 'Pei', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.""}, {'ForeName': 'Pengde', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': ""Department of Orthopedic Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan Province, People's Republic of China.""}]",The Journal of arthroplasty,['10.1016/j.arth.2019.07.045']
1078,32439482,Inflammatory and fibroblastic effects of azithromycin on cyclosporine-induced gingival overgrowth in renal transplanted patients with and without scaling: A randomized clinical trial.,"BACKGROUND


This study aimed to evaluate the effect of azithromycin (AZM) on the inflammatory and fibroblastic part of cyclosporine A (CsA)-induced gingival overgrowth (GO) in renal transplanted patients.
METHODS


In this randomized clinical trial, subjects with GO receiving CsA were randomly divided into two groups: those receiving 5-day AZM only (n = 12; group 1) and those receiving scaling and prescribed AZM after 2 months (n = 12; group 2). Both groups were evaluated for several indices (gingival hyperplastic index, plaque and bleeding index, clinical crown length) at the first visit and the 4th and 8th week in group 1, and at the first visit and the 4th, 8th, 12th, and 16th week in group 2.
RESULTS


The sample included 24 individuals. The mean (SD) age of participants was 30.81 (11.13) and 34.80 (9.33) years in group 1 and 2, respectively. Based on ANCOVA, the changes in the hyperplastic index (GHI) and apico-coronal dimension (ACD) of it were statistically significant in professional scaling accompanied by AZM group (P = 0.012 and 0.031, respectively). However, no significant change was observed in mean indices after prescribing AZM in 5-day AZM regimen group (P = 0.664 and 0.882, respectively). According to one-way ANOVA, we found a statistically significant correlation in GHI, ACD, bleeding index (BI), and plaque index (PI) accounting for P = 0.012, 0.003, 0.002, and <0.001, respectively.
CONCLUSIONS


Findings suggest that AZM cannot influence the fibroblastic part of GO in presence of gum inflammation while the therapy can improve GO after resolving it with scaling.",2020,"Both groups were evaluated for several indices (gingival hyperplastic index, plaque and bleeding index, clinical crown length) at the first visit and the 4th and 8th week in group 1, and at the first visit and the 4th, 8th, 12th, and 16th week in group 2.
","['renal transplanted patients', 'The sample included 24 individuals', 'renal transplanted patients with and without scaling', 'subjects with GO receiving CsA']","['cyclosporine A (CsA)-induced gingival overgrowth (GO', 'AZM', 'receiving scaling and prescribed AZM', '5-day AZM', 'azithromycin (AZM', 'azithromycin', 'cyclosporine']","['gingival overgrowth', 'several indices (gingival hyperplastic index, plaque and bleeding index, clinical crown length', 'GHI, ACD, bleeding index (BI), and plaque index (PI', 'Inflammatory and fibroblastic effects', 'hyperplastic index (GHI) and apico-coronal dimension (ACD', 'mean indices', 'professional scaling']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0376480', 'cui_str': 'Gingival enlargement'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0376480', 'cui_str': 'Gingival enlargement'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0376480', 'cui_str': 'Gingival enlargement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",24.0,0.0349711,"Both groups were evaluated for several indices (gingival hyperplastic index, plaque and bleeding index, clinical crown length) at the first visit and the 4th and 8th week in group 1, and at the first visit and the 4th, 8th, 12th, and 16th week in group 2.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Beihaghi', 'Affiliation': 'Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Periodontics, School of Dentistry, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Zarei', 'Affiliation': 'Department of Oral Medicine, School of Dentistry, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Azmandian', 'Affiliation': 'Department of Nephrology, Shafa Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Hamidreza Baghani', 'Initials': 'HB', 'LastName': 'Aval', 'Affiliation': 'Department of Urology, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran. Electronic address: https://mail.google.com/mail/u/0/h/sif60x9sjdad/?&cs=wh&v=b&to=hamidreza_baghani@yahoo.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebkar', 'Affiliation': 'Department of Social Medicine, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Journal of oral biosciences,['10.1016/j.job.2020.04.001']
1079,31495419,"An equine-assisted therapy intervention to improve pain, range of motion, and quality of life in adults and older adults with arthritis: A randomized controlled trial.","RESEARCH AIM


To compare equine-assisted therapy to exercise education on pain, range of motion, and quality of life in adults and older adults with arthritis.
BACKGROUND


Quality of life for adults and older adults is negatively impacted by arthritis pain, stiffness, and decreased function. Equine-assisted therapy provides unique movements to the rider's joints and muscles improving pain, range of motion, and quality of life and has improved outcomes in balance, gait, strength, functional mobility, and spasticity for older adults, stroke, spinal cord injury, and multiple sclerosis patients. No research has investigated the effects on adults and older adults with arthritis.
METHODS


Twenty adults and older adults with arthritis recruited from rheumatology clinics participated in a randomized controlled trial for six weeks. Participants and research assistants were blinded to assignment. Standardized valid and reliable instruments were used to measure pain, range of motion, and quality of life targeting back, knees, shoulders, and hips.
RESULTS


Mean age was 63.85 (SD 6.885, 53-75) years. Pain significantly improved in shoulders (p = 0.007), hips (p = 0.027), and back (p = 0.006), not knees (p = 0.061). Range of motion improved for back (p = 0.02), hips (p = 0.04), shoulders (p = 0.005) and not knees. Quality of life improved for upper limb (p = 0.002), lower limb (p = 0.021), and affect (p = 0.030), not social interaction and symptoms.
CONCLUSION


This randomized controlled trial provides evidence that equine-assisted therapy decreases pain, and improves range of motion, and quality of life for adults and older adults with arthritis. Further fully powered research with cost/benefit outcomes would be beneficial.",2019,"Range of motion improved for back (p = 0.02), hips (p = 0.04), shoulders (p = 0.005) and not knees.","['adults and older adults with arthritis', 'Twenty adults and older adults with arthritis recruited from rheumatology clinics', 'adults and older adults', 'Mean age was 63.85 (SD 6.885, 53-75) years']","['equine-assisted therapy to exercise education', 'equine-assisted therapy intervention', 'Equine-assisted therapy']","['pain, range of motion, and quality of life', 'pain, range of motion, and quality of life targeting back, knees, shoulders, and hips', 'Quality of life improved for upper limb', 'social interaction and symptoms', 'Range of motion improved for back', 'Pain', 'lower limb', 'pain, and improves range of motion, and quality of life']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C3812871', 'cui_str': 'Rheumatology clinic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2717786', 'cui_str': 'Equine-Assisted Therapy'}, {'cui': 'C0582396', 'cui_str': 'Exercise health education'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0034380'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",20.0,0.098021,"Range of motion improved for back (p = 0.02), hips (p = 0.04), shoulders (p = 0.005) and not knees.","[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'White-Lewis', 'Affiliation': 'School of Nursing and Health Studies, University of Missouri-Kansas City, 2464 Charlotte Street, Kansas City, MO 64108, United States of America. Electronic address: whitelewiss@umkc.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Johnson', 'Affiliation': 'Research Center for Human-Animal Interaction, MU College of Veterinary Medicine, University of Missouri, 900 East Campus Drive, Columbia, MO 65201, United States of America. Electronic address: rajohnson@missouri.edu.'}, {'ForeName': 'Sangbeak', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'School of Nursing and Health Studies, University of Missouri-Kansas City, 2464 Charlotte Street, Kansas City, MO 64108, United States of America. Electronic address: yesa@umkc.edu.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'School of Nursing and Health Studies, University of Missouri-Kansas City, 2464 Charlotte Street, Kansas City, MO 64108, United States of America. Electronic address: russellc@umkc.edu.'}]",Applied nursing research : ANR,['10.1016/j.apnr.2019.07.002']
1080,32494981,Comparison of S-1-cisplatin every 5 weeks with capecitabine-cisplatin every 3 weeks for HER2-negative gastric cancer (recurrent after S-1 adjuvant therapy or chemotherapy-naïve advanced): pooled analysis of HERBIS-2 (OGSG 1103) and HERBIS-4A (OGSG 1105) trials.,"BACKGROUND


We previously reported the HERBIS-4A phase II trial comparing S-1 plus cisplatin (SP) with capecitabine plus cisplatin (XP) in chemotherapy-naïve patients with HER2-negative advanced gastric cancer (GC). We performed a pooled analysis of HERBIS-4A and HERBIS-2, the phase II trial comparing SP with XP in HER2-negative recurrent GC patients with a recurrence-free interval after S-1 adjuvant therapy of ≥ 6 months.
PATIENTS AND METHODS


Patients were randomly assigned to receive either SP [S-1 (40-60 mg twice daily for 21 days) plus cisplatin (60 mg/m 2  on day 8), every 5 weeks] or XP [capecitabine (1000 mg/m 2  twice daily for 14 days) plus cisplatin (80 mg/m 2  on day 1), every 3 weeks].
RESULTS


In the pooled analysis, SP (n = 44-50) showed a longer progression-free survival [6.4 versus 5.1 months; hazard ratio (HR), 0.666; P = 0.062], overall survival (14.8 versus 10.6 months; HR, 0.695; P = 0.099), and time to treatment failure (4.6 versus 3.6 months; HR, 0.668; P = 0.045) as well as a higher disease control rate (86.4% versus 68.1%, P = 0.149) compared with XP (n = 47-51). A significant survival advantage for SP over XP was apparent in patients with a performance status of 0, a differentiated-type tumor histology, or a primary tumor localization to the upper portion of the stomach.
CONCLUSION


Our pooled analysis supports the use of SP in the first-line setting for patients with HER2-negative advanced or recurrent GC with a recurrence-free interval of ≥ 6 months.
CLINICAL TRIAL REGISTRATION


The HERBIS-2 trial was registered with UMIN-CTR as UMIN000006105.",2020,"A significant survival advantage for SP over XP was apparent in patients with a performance status of 0, a differentiated-type tumor histology, or a primary tumor localization to the upper portion of the stomach.
","['HER2-negative recurrent GC patients with a recurrence-free interval after S-1 adjuvant therapy of\u2009≥\u20096\xa0months', 'Patients', 'chemotherapy-naïve patients with HER2-negative advanced gastric cancer (GC', 'HER2-negative gastric cancer (recurrent after S-1 adjuvant therapy or chemotherapy-naïve advanced', 'patients with HER2-negative advanced or recurrent GC with a recurrence-free interval of\u2009≥\u20096\xa0months']","['S-1 plus cisplatin (SP) with\xa0capecitabine plus cisplatin (XP', 'XP', 'S-1-cisplatin', 'capecitabine-cisplatin', 'SP [S-1', 'cisplatin', 'XP [capecitabine']","['time to treatment failure', 'longer progression-free survival', 'overall survival', 'disease control rate']","[{'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0278502', 'cui_str': 'Gastric cancer recurrent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]","[{'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C3494202', 'cui_str': 'Time to Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.153097,"A significant survival advantage for SP over XP was apparent in patients with a performance status of 0, a differentiated-type tumor histology, or a primary tumor localization to the upper portion of the stomach.
","[{'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Kawakami', 'Affiliation': 'Department of Medical Oncology, Faculty of Medicine, Kindai University, 377-2 Ohno-higashi, Osaka-sayama, Osaka, 589-8511, Japan. kawakami_h@med.kindai.ac.jp.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Fujitani', 'Affiliation': 'Department of Surgery, Osaka Prefectural General Medical Center, Osaka-shi, Japan.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Matsuyama', 'Affiliation': 'Department of Gastroenterological Surgery, Higashiosaka City Medical Center, Higashiosaka, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Akamaru', 'Affiliation': 'Department of Surgery, Ikeda Municipal Hospital, Ikeda, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Surgery, Yao Municipal Hospital, Yao, Japan.'}, {'ForeName': 'Shunji', 'Initials': 'S', 'LastName': 'Endo', 'Affiliation': 'Department of Surgery, Faculty of Medicine, Kindai University, Osaka-sayama, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': 'Department of Surgery, Sakai City Medical Center, Sakai, Japan.'}, {'ForeName': 'Youichi', 'Initials': 'Y', 'LastName': 'Makari', 'Affiliation': 'Department of Medical Oncology, Kindai University Nara Hospital, Ikoma, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'Cancer Center, Izumi City General Hospital, Izumi, Japan.'}, {'ForeName': 'Toshimasa', 'Initials': 'T', 'LastName': 'Tsujinaka', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Kurokawa', 'Affiliation': 'Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Taroh', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of clinical oncology,['10.1007/s10147-020-01711-z']
1081,31391387,Efficacy and Safety of Ivabradine in Japanese Patients With Chronic Heart Failure　- J-SHIFT Study.,"BACKGROUND


Increased heart rate (HR) is an independent risk factor for cardiovascular outcomes in chronic heart failure (HF). Ivabradine, anI f inhibitor, improved outcomes in patients with HF and reduced ejection fraction (HFrEF) in the SHIFT study. We evaluated its efficacy and safety in Japanese HFrEF patients in a randomized, double-blind, placebo-controlled phase III study: the J-SHIFT study. The main objective was to confirm a hazard ratio of <1 in the primary composite endpoint of cardiovascular death or hospital admission for worsening HF.Methods and Results:Patients with NYHA functional class II-IV, left ventricular EF ≤35%, and resting HR ≥75 beats/min in sinus rhythm under optimal medical therapy received ivabradine (n=127) or placebo (n=127). Mean reduction in resting HR was significantly greater in the ivabradine group (15.2 vs. 6.1 beats/min, P<0.0001). However, symptomatic bradycardia did not occur. A total of 26 (20.5%) patients in the ivabradine group and 37 (29.1%) patients in the placebo group had the primary endpoint event (hazard ratio 0.67, 95% CI 0.40-1.11, P=0.1179) during median follow-up of 589 days. Mild phosphenes were reported in 8 (6.3%) patients in the ivabradine group and 4 (3.1%) patients in the placebo group (P=0.3760).
CONCLUSIONS


The J-SHIFT study supported the efficacy and safety of ivabradine for Japanese HFrEF patients, in accord with the SHIFT study.",2019,"Mean reduction in resting HR was significantly greater in the ivabradine group (15.2 vs. 6.1 beats/min, P<0.0001).","['Japanese HFrEF patients', 'patients with HF and reduced ejection fraction (HFrEF) in the SHIFT study', 'chronic heart failure (HF', 'Japanese Patients With Chronic Heart Failure\u3000- J-SHIFT Study']","['Ivabradine', 'ivabradine', 'placebo', 'Ivabradine, anI']","['symptomatic bradycardia', 'Mean reduction in resting HR', 'cardiovascular death or hospital admission', 'efficacy and safety', 'Efficacy and Safety', 'Mild phosphenes']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0326040', 'cui_str': 'Ani'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}]",,0.199184,"Mean reduction in resting HR was significantly greater in the ivabradine group (15.2 vs. 6.1 beats/min, P<0.0001).","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsutsui', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kyushu University.'}, {'ForeName': 'Shin-Ichi', 'Initials': 'SI', 'LastName': 'Momomura', 'Affiliation': 'Cardiovascular Division, Jichi Medical University, Saitama Medical Center.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yamashina', 'Affiliation': 'Department of Cardiology, Tokyo Medical University.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine.'}, {'ForeName': 'Yasuki', 'Initials': 'Y', 'LastName': 'Kihara', 'Affiliation': 'Department of Cardiovascular Medicine, Hiroshima University Graduate School of Biomedical & Health Sciences.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'First Department of Internal Medicine, Nara Medical University.'}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, Tokyo Women's Medical University.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Yano', 'Affiliation': 'Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Cardiovascular Medicine, Endocrinology and Metabolism, Department of Molecular Medicine and Therapeutics, Faculty of Medicine, Tottori University.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Ako', 'Affiliation': 'Cardiovascular Medicine, Kitasato University.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Inomata', 'Affiliation': 'Cardiovascular Medicine, Kitasato University Kitasato Institute Hospital.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Sakata', 'Affiliation': 'Department of Cardiovascular Medicine, Graduate School of Medicine, Osaka University.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tanaka', 'Affiliation': 'Department of Clinical Development, Ono Pharmaceutical Co., Ltd.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Clinical Development, Ono Pharmaceutical Co., Ltd.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0227']
1082,31862574,The effects of imagery rescripting on memory outcomes in social anxiety disorder.,"Imagery rescripting (IR) is an effective intervention for social anxiety disorder (SAD) that targets negative autobiographical memories. IR has been theorized to work through various memory mechanisms, including modifying the content of negative memory representations, changing memory appraisals, and improving negative schema or core beliefs about self and others. However, no prior studies have investigated the unique effects of rescripting itself relative to other IR intervention components on these proposed mechanisms. In this preliminary study, 33 individuals with SAD were randomized to receive a single session of IR, imaginal exposure (IE), or supportive counselling (SC). Memory outcomes were assessed at 1- and 2-weeks post-intervention and at 3-months follow-up. Results demonstrated that the content of participants' autobiographical memory representations changed in distinct ways across the three conditions. Whereas IR facilitated increases only in positive/neutral memory details, IE facilitated increases in both positive/neutral and negative memory details and SC facilitated no changes in memory details. Although memory appraisals did not differ across conditions, participants who received IR were more likely to update their negative memory-derived core beliefs. These unique effects of rescripting on memory representations and core beliefs enhance our understanding of the memory-based mechanisms of IR within the context of exposure-based learning for people with SAD.",2020,"Although memory appraisals did not differ across conditions, participants who received IR were more likely to update their negative memory-derived core beliefs.","['33 individuals with SAD', 'social anxiety disorder', 'people with SAD']","['Imagery rescripting (IR', 'imagery rescripting', 'single session of IR, imaginal exposure (IE), or supportive counselling (SC']","['positive/neutral memory details, IE facilitated increases in both positive/neutral and negative memory details and SC facilitated no changes in memory details', 'Memory outcomes', 'autobiographical memory representations']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C3697360', 'cui_str': 'Supportive counseling'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0557930', 'cui_str': 'Unpleasant memories (finding)'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}]",33.0,0.0231793,"Although memory appraisals did not differ across conditions, participants who received IR were more likely to update their negative memory-derived core beliefs.","[{'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Romano', 'Affiliation': 'Department of Psychology and Centre for Mental Health Research and Treatment, University of Waterloo, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Moscovitch', 'Affiliation': 'Department of Psychology and Centre for Mental Health Research and Treatment, University of Waterloo, Canada. Electronic address: dmosco@uwaterloo.ca.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Huppert', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Susanna G', 'Initials': 'SG', 'LastName': 'Reimer', 'Affiliation': 'Department of Psychology and Centre for Mental Health Research and Treatment, University of Waterloo, Canada.'}, {'ForeName': 'Morris', 'Initials': 'M', 'LastName': 'Moscovitch', 'Affiliation': 'University of Toronto and the Rotman Research Institute and Department of Psychology, Baycrest Centre for Geriatric Care, Canada.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.102169']
1083,31732174,The effects of intensive dietary weight loss and exercise on gait in overweight and obese adults with knee osteoarthritis. The Intensive Diet and Exercise for Arthritis (IDEA) trial.,"The Intensive Diet and Exercise for Arthritis (IDEA) trial was an 18-month randomized controlled trial that enrolled 454 overweight and obese older adults with symptomatic and radiographic knee osteoarthritis (OA). Participants were randomized to either exercise (E), intensive diet-induced weight loss (D), or intensive diet-induced weight loss plus exercise (D + E) interventions. We previously reported that the clinical benefits of D + E were significantly greater than with either intervention alone (e.g., greater pain reduction, and better function, mobility, and health-related quality of life). We now test the hypothesis that D + E has greater overall benefit on gait mechanics compared to either intervention alone. Knee joint loading was analyzed using inverse dynamics and musculoskeletal modeling. Analysis of covariance determined the interventions' effects on gait. The D + E group walked significantly faster at 18-month follow-up (1.35 m s -1 ) than E (1.29 m s -1 , p = 0.0004) and D (1.31 m s -1 , p = 0.0007). Tibiofemoral compressive impulse was significantly lower (p = 0.0007) in D (1069 N s) and D + E (1054 N s) compared to E (1130 N s). D had significantly lower peak hip external rotation moment (p = 0.01), hip abduction moment (p = 0.0003), and peak hip power production (p = 0.016) compared with E. Peak ankle plantar flexion moment was significantly less (p < 0.0001) in the two diet groups compared with E. There also was a significant dose-response to weight loss; participants that lost >10% of baseline body weight had significantly (p = 0.0001) lower resultant knee forces and lower muscle (quadriceps, hamstring, and gastrocnemius) forces than participants that had less weight loss. Compared to E, D produces significant load reductions at the hip, knee, and ankle; combining D with E attenuates these reductions, but most remain significantly better than with E alone.",2020,"D had significantly lower peak hip external rotation moment (p = 0.01), hip abduction moment (p = 0.0003), and peak hip power production (p = 0.016) compared with E. Peak ankle plantar flexion moment was significantly less (p < 0.0001) in the two diet groups compared with E. There also was a significant dose-response to weight loss; participants that lost >10% of baseline body weight had significantly (p = 0.0001) lower resultant knee forces and lower muscle (quadriceps, hamstring, and gastrocnemius) forces than participants that had less weight loss.","['overweight and obese adults with knee osteoarthritis', 'enrolled 454 overweight and obese older adults with symptomatic and radiographic knee osteoarthritis (OA']","['intensive dietary weight loss and exercise', 'exercise (E), intensive diet-induced weight loss (D), or intensive diet-induced weight loss plus exercise (D\u202f+\u202fE) interventions']","['Peak ankle plantar flexion moment', 'Tibiofemoral compressive impulse', 'peak hip power production', 'hip abduction moment', 'peak hip external rotation moment', 'pain reduction, and better function, mobility, and health-related quality of life', 'Knee joint loading', 'resultant knee forces and lower muscle (quadriceps, hamstring, and gastrocnemius) forces', 'weight loss']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C4517782', 'cui_str': '454 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0231784', 'cui_str': 'Plantar flexion, function (observable entity)'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0033268'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0231462', 'cui_str': 'Lateral rotation - action (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0022745', 'cui_str': 'Superior Tibiofibular Joint'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]",454.0,0.0468876,"D had significantly lower peak hip external rotation moment (p = 0.01), hip abduction moment (p = 0.0003), and peak hip power production (p = 0.016) compared with E. Peak ankle plantar flexion moment was significantly less (p < 0.0001) in the two diet groups compared with E. There also was a significant dose-response to weight loss; participants that lost >10% of baseline body weight had significantly (p = 0.0001) lower resultant knee forces and lower muscle (quadriceps, hamstring, and gastrocnemius) forces than participants that had less weight loss.","[{'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Messier', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA; Section on Gerontology and Geriatric Medicine, Wake Forest University School of Medicine, USA. Electronic address: messier@wfu.edu.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, USA. Electronic address: dbeavers@wakehealth.edu.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Mihalko', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA. Electronic address: mihalksl@wfu.edu.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Miller', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, USA. Electronic address: millergd@wfu.edu.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Lyles', 'Affiliation': 'Section on Gerontology and Geriatric Medicine, Wake Forest University School of Medicine, USA. Electronic address: mlyles@wakehealth.edu.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hunter', 'Affiliation': 'Institute of Bone and Joint Research, Kolling Institute, University of Sydney, Sydney, Australia; Rheumatology Department, Royal North Shore Hospital, Australia. Electronic address: david.hunter@sydney.edu.au.'}, {'ForeName': 'J Jeffery', 'Initials': 'JJ', 'LastName': 'Carr', 'Affiliation': 'Department of Radiology, Vanderbilt School of Medicine, Nashville, TN, USA. Electronic address: j.jeffrey.carr@vanderbilt.edu.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Eckstein', 'Affiliation': 'Institute of Anatomy and Musculoskeletal Research, Paracelsus Medical University, Salzburg, Austria, & Chondrometrics GmbH, Ainring, Germany. Electronic address: felix.eckstein@pmu.ac.at.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Department of Radiology, Boston University School of Medicine, Boston, MA, USA. Electronic address: guermazi@bu.edu.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Loeser', 'Affiliation': 'Thurston Arthritis Research Center, University of North Carolina School of Medicine, Chapel Hill, NC, USA. Electronic address: richard_loeser@med.unc.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'DeVita', 'Affiliation': 'Department of Kinesiology, East Carolina University, Greenville, NC, USA. Electronic address: DEVITAP@ecu.edu.'}]",Journal of biomechanics,['10.1016/j.jbiomech.2019.109477']
1084,30686750,The Effect of Long-Term Cholecalciferol Supplementation on Vascular Calcification in Chronic Kidney Disease Patients With Hypovitaminosis D.,"OBJECTIVE


The role of vitamin D supplementation on vascular calcification (VC) in patients with chronic kidney disease (CKD) is controversial. The objective of this study was to evaluate the effects of long-term cholecalciferol supplementation on VC in nondialysis patients with CKD stages 3-4 with hypovitaminosis D.
DESIGN AND METHODS


Eighty patients aged 18-85 years with creatinine clearance between 15 and 60 mL/min/1.73 m 2  and serum 25(OH)D level < 30 ng/mL were enrolled in a 18-month prospective study. Individuals with vitamin D insufficiency (25-hydroxyvitamin D [25(OH)D] level between 16 and 29 ng/mL) were included in a randomized, double-blind, two-arm study to receive cholecalciferol or placebo. Patients with vitamin D deficiency [25(OH)D < 15 ng/mL] were included in an observational study and mandatorily received cholecalciferol. The coronary artery calcium score was obtained by multislice computed tomography at baseline and the 18th month.
RESULTS


During the study, VC did not change in the treated insufficient group (418 [81-611] to 364 [232-817] AU, P = 0.25) but increased in the placebo group (118 [37-421] to 199 [49-490] AU, P = 0.01). The calcium score change was inversely correlated with 25(OH)D change (r = -0.45; P = 0.037) in the treated insufficient group but not in the placebo group. Renal function did not change in the insufficient, treated, and placebo groups. In multivariate analysis, there was no difference in VC progression between the treated and placebo insufficient groups (interaction P = 0.92). In the deficient group, VC progressed (265 [84-733] to 333 [157-745] AU; P = 0.006) and renal function declined (33 [26-43] to 23 [17-49] mL/min/1.73 m 2 ; P = 0.04). The calcium score change was inversely correlated with cholecalciferol cumulative doses (r = -0.41; P = 0.048) and kidney function change (r = -0.43; P = 0.033) but not with 25(OH)D change (r = -0.08; P = 0.69).
CONCLUSION


Vitamin D supplementation did not attenuate VC progression in CKD patients with hypovitaminosis D.
CONCLUSION


Vitamin D supplementation did not attenuate VC progression in CKD patients with hypovitaminosis D.",2019,"In multivariate analysis, there was no difference in VC progression between the treated and placebo insufficient groups (interaction P = 0.92).","['Eighty patients aged 18-85 years with creatinine clearance between 15 and 60 mL/min/1.73 m 2  and serum 25(OH)D level < 30 ng/mL were enrolled in a 18-month prospective study', 'nondialysis patients with CKD stages 3-4 with hypovitaminosis D', 'Chronic Kidney Disease Patients With Hypovitaminosis D', 'patients with chronic kidney disease (CKD', 'CKD patients with hypovitaminosis D', 'Patients with vitamin D deficiency [25(OH)D < 15 ng/mL', 'Individuals with vitamin D insufficiency (25-hydroxyvitamin D [25(OH)D] level between 16 and 29 ng/mL']","['vitamin D supplementation', 'placebo', 'cholecalciferol or placebo', 'Long-Term Cholecalciferol Supplementation', 'Vitamin D supplementation', 'cholecalciferol', 'long-term cholecalciferol supplementation']","['Renal function', 'renal function', 'Vascular Calcification', 'kidney function change', 'vascular calcification (VC', 'VC progression', 'calcium score change', 'coronary artery calcium score']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine (procedure)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C2316787', 'cui_str': 'CKD stage 3'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency (finding)'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0342649', 'cui_str': 'Vascular Calcinosis'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3484386', 'cui_str': 'Coronary artery calcium score'}]",80.0,0.300409,"In multivariate analysis, there was no difference in VC progression between the treated and placebo insufficient groups (interaction P = 0.92).","[{'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'Samaan', 'Affiliation': 'Nephrology Division, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Aluízio B', 'Initials': 'AB', 'LastName': 'Carvalho', 'Affiliation': 'Nephrology Division, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Pillar', 'Affiliation': 'Nephrology Division, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lillian A', 'Initials': 'LA', 'LastName': 'Rocha', 'Affiliation': 'Nephrology Division, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Cassiolato', 'Affiliation': 'Cardios Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Cuppari', 'Affiliation': 'Nephrology Division, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria Eugênia F', 'Initials': 'MEF', 'LastName': 'Canziani', 'Affiliation': 'Nephrology Division, Federal University of São Paulo, São Paulo, Brazil. Electronic address: dialisefor@uol.com.br.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2018.12.002']
1085,31331777,Trivalent influenza vaccination randomized control trial of pregnant women and adverse fetal outcomes.,"INTRODUCTION


The purpose of this study was to evaluate the association of influenza vaccine during pregnancy and adverse fetal outcomes. Preventing fetal death, low birth weight, small for gestational age birth and preterm birth are important potential effects of antenatal maternal influenza immunization for which there are conflicting data.
MATERIALS AND METHODS


A double-blind, randomized, placebo-controlled clinical trial of trivalent inactivated influenza vaccine was conducted in South Africa from March 2011 until after the 2012 influenza season when the infants born had reached the age of 24 weeks. Mothers were administered the vaccine or placebo during pregnancy at a gestation of 20 to 36 weeks. A comparison of rates of fetal death, low birth weight, small for gestational age birth, and preterm birth, between vaccinated and placebo groups was made. Fetal outcome differences between the groups were measured using Student's t-tests, vaccine efficacy with 95% confidence intervals, and Poisson regression for incidence rates. All analyses except fetal death excluded mothers who were administered vaccine or placebo after 34 weeks gestational age.
RESULTS


There were 2116 HIV-uninfected pregnant women age 18 to 38 years in the trial; 2005 infants were born to mothers where vaccine or placebo had been administered ≥ 14 days prior to delivery, and there were 6 miscarriages and 23 stillbirths. There was no significant vaccine efficacy (with [95% confidence interval]) on fetal death (-21.2% [-150.8, 41.4]), low birth weight (-11.1% [-42.3, 12.5]), small for gestational age birth (-9.9% [-35.6, 11.0]), or preterm birth (-21.3% [-60.5, 8.3]). Neither was vaccine efficacy demonstrated when the analysis was restricted to infants of mothers who were exposed to an influenza season (1832 outcomes available).
CONCLUSION


We did not find a beneficial effect of trivalent inactivated influenza vaccine during pregnancy on adverse fetal outcomes.",2019,"There was no significant vaccine efficacy (with [95% confidence interval]) on fetal death (-21.2% [-150.8, 41.4]), low birth weight (-11.1% [-42.3, 12.5]), small for gestational age birth (-9.9% [-35.6, 11.0]), or preterm birth (-21.3% [-60.5, 8.3]).","['pregnant women and adverse fetal outcomes', 'South Africa from March 2011 until after the 2012 influenza season when the infants born had reached the age of 24\u202fweeks', '2116 HIV-uninfected pregnant women age 18 to 38\u202fyears in the trial; 2005 infants were born to mothers where']","['influenza vaccine', 'vaccine or placebo', 'placebo', 'trivalent inactivated influenza vaccine']","['adverse fetal outcomes', 'preterm birth', 'rates of fetal death, low birth weight, small for gestational age birth, and preterm birth', 'fetal death', 'vaccine efficacy', 'low birth weight', 'small for gestational age birth', 'fetal death, low birth weight, small for gestational age birth and preterm birth', ""Student's t-tests, vaccine efficacy""]","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0015927', 'cui_str': 'Fetal Demise'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",2116.0,0.602901,"There was no significant vaccine efficacy (with [95% confidence interval]) on fetal death (-21.2% [-150.8, 41.4]), low birth weight (-11.1% [-42.3, 12.5]), small for gestational age birth (-9.9% [-35.6, 11.0]), or preterm birth (-21.3% [-60.5, 8.3]).","[{'ForeName': 'Eric A F', 'Initials': 'EAF', 'LastName': 'Simões', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Colorado School of Public Health, Center for Global Health, University of Colorado School of Medicine, Aurora Colorado, 13123 E. 16(th) Ave., B055 Aurora, CO, United States; University of Colorado Denver, Dept. of Pediatric Infectious Diseases, 13123 E. 16(th) Ave, B055 Aurora, CO, United States.'}, {'ForeName': 'Marta C', 'Initials': 'MC', 'LastName': 'Nunes', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Carosone-Link', 'Affiliation': 'University of Colorado Denver, Dept. of Pediatric Infectious Diseases, 13123 E. 16(th) Ave, B055 Aurora, CO, United States. Electronic address: Phyllis.CarosoneLink@ucdenver.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Madimabe', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa.'}, {'ForeName': 'Justin R', 'Initials': 'JR', 'LastName': 'Ortiz', 'Affiliation': 'University of Maryland Center for Vaccine Development, 685 W Baltimore St, Baltimore, MD, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Neuzil', 'Affiliation': 'University of Maryland Center for Vaccine Development, 685 W Baltimore St, Baltimore, MD, USA.'}, {'ForeName': 'Keith P', 'Initials': 'KP', 'LastName': 'Klugman', 'Affiliation': 'Bill and Melinda Gates Foundation, 500 5th Ave N, Seattle, WA, USA.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, University of the Witwatersrand, York Road, Parktown, Johannesburg 2193, South Africa; National Institute for Communicable Diseases: a division of National Health Laboratory Service, Centre for Vaccines and Immunology, 1 Modderfontein Road, Sandringham, Johannesburg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Vaccine,['10.1016/j.vaccine.2019.07.024']
1086,31125720,Comparison of Carbon Dioxide Absorption Rates in Gynecologic Laparoscopy with a Valveless versus Standard Insufflation System: Randomized Controlled Trial.,"STUDY OBJECTIVE


The primary objective was to compare carbon dioxide (CO 2 ) absorption rates in patients undergoing gynecologic laparoscopy with a standard versus valveless insufflation system (AirSeal; ConMed, Utica, NY) at intra-abdominal pressures (IAPs) of 10 and 15 mm Hg. Secondary objectives were assessment of surgeons' visualization of the operative field, anesthesiologists' ability to maintain adequate end-tidal CO 2  (etCO 2 ), and patients' report of postoperative shoulder pain.
DESIGN


A randomized controlled trial using an equal allocation ratio into 4 arms: standard insufflation/IAP 10 mm Hg, standard insufflation/IAP 15 mm Hg, valveless insufflation/IAP 10 mm Hg, and valveless insufflation/IAP 15 mm Hg.
SETTING


Single tertiary care academic institution.
PATIENTS


Women ≥ 18 years old undergoing nonemergent conventional or robotic gynecologic laparoscopic surgery.
INTERVENTIONS


A standard or valveless insufflation system at IAPs of 10 or 15 mm Hg.
MEASUREMENTS AND MAIN RESULTS


One hundred thirty-two patients were enrolled and randomized with 33 patients per group. There were 84 robotic cases and 47 conventional laparoscopic cases. CO 2  absorption rates (mL/kg*min) did not differ across groups with mean rates of 4.00 ± 1.3 in the valveless insufflation groups and 4.00 ± 1.1 in the standard insufflation groups. The surgeons' rating of overall visualization of the operative field on a 10-point Likert scale favored the valveless insufflation system (median visualization, 9.0 ± 2.0 cm and 9.5 ± 1.8 cm at 10 and 15 mm Hg, respectively) over standard insufflation (7.0 ± 3.0 cm and 7.0 ± 2.0 cm at 10 and 15 mm Hg, respectively; p <.001). The anesthesiologists' ability to maintain adequate etCO 2  was similar across groups (p = .417). Postoperative shoulder pain scores were low overall with no significant difference across groups (p >.05).
CONCLUSION


CO 2  absorption rates, anesthesiologists' ability to maintain adequate etCO 2 , and postoperative shoulder pain did not differ based on insufflation system type or IAP. Surgeons' rating of visualization of the operative field was significantly improved when using the valveless over the standard insufflation system.",2020,Surgeons' rating of visualization of the operative field was significantly improved when using the valveless over the standard insufflation system.,"['Gynecologic Laparoscopy with a Valveless versus Standard Insufflation System', 'patients undergoing gynecologic laparoscopy with a standard versus valveless insufflation system (AirSeal; ConMed, Utica, NY) at intra-abdominal pressures (IAPs) of 10 and 15 mm Hg', 'One hundred thirty-two patients were enrolled and randomized with 33 patients per group', 'Women ≥ 18 years old undergoing', 'Single tertiary care academic institution']","['nonemergent conventional or robotic gynecologic laparoscopic surgery', 'equal allocation ratio into 4 arms: standard insufflation/IAP 10 mm Hg, standard insufflation/IAP 15 mm Hg, valveless insufflation']","[""Surgeons' rating of visualization of the operative field"", 'Postoperative shoulder pain scores', 'carbon dioxide (CO 2 ) absorption rates', 'Carbon Dioxide Absorption Rates', 'postoperative shoulder pain', 'CO 2  absorption rates', ""surgeons' visualization of the operative field, anesthesiologists' ability to maintain adequate end-tidal CO 2  (etCO 2 ), and patients' report of postoperative shoulder pain""]","[{'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0429218', 'cui_str': 'Abdominal pressure (observable entity)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",132.0,0.215547,Surgeons' rating of visualization of the operative field was significantly improved when using the valveless over the standard insufflation system.,"[{'ForeName': 'Obianuju S', 'Initials': 'OS', 'LastName': 'Madueke-Laveaux', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York. Electronic address: somadueke@gmail.com.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Advincula', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Cara L', 'Initials': 'CL', 'LastName': 'Grimes', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Walters', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Jin Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Khara', 'Initials': 'K', 'LastName': 'Simpson', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Mireille', 'Initials': 'M', 'LastName': 'Truong', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Young', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Landau', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Ryntz', 'Affiliation': 'Departments of Obstetrics and Gynecology (Drs. Advincula, Walters, Kim, and Ryntz); Anesthesiology (Dr. Landau), Columbia University Medical Center, New York, New York; Department of Obstetrics and Gynecology (Dr. Madueke-Laveaux), University of Chicago, Chicago, Illinois; Department of Obstetrics and Gynecology (Dr. Grimes), New York Medical College, Valhalla, New York; Department of Obstetrics and Gynecology (Dr. Simpson), Johns Hopkins University, Baltimore, Maryland; Department of Obstetrics and Gynecology (Dr. Truong), Virginia Commonwealth University, Richmond, Virginia; Department of Obstetrics and Gynecology (Dr. Young), Mount Sinai Hospital, New York, New York.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2019.05.005']
1087,31415063,Effect of Home-Based Exercise and Weight Loss Programs on Breast Cancer-Related Lymphedema Outcomes Among Overweight Breast Cancer Survivors: The WISER Survivor Randomized Clinical Trial.,"Importance


To our knowledge, no randomized clinical trials have assessed the effects of the combination of weight loss and home-based exercise programs on lymphedema outcomes.
Objective


To assess weight loss, home-based exercise, and the combination of weight loss and home-based exercise with clinical lymphedema outcomes among overweight breast cancer survivors.
Design, Setting, and Participants


This randomized clinical trial (Women in Steady Exercise Research [WISER] Survivor clinical trial ) of 351 overweight breast cancer survivors with breast cancer-related lymphedema (BCRL) was conducted in conference rooms at academic and community hospitals and in the homes of participants from March 12, 2012, to May 28, 2016; follow-up was conducted for 1 year from the start of the intervention. Statistical analysis by intention to treat was performed from September 26, 2018, to October 28, 2018.
Interventions


A 52-week, home-based exercise program of strength/resistance training twice per week and 180 minutes of walking per week, a weight loss program of 20 weeks of meal replacements and 52 weeks of lifestyle modification counseling, and a combination of the home-based exercise and weight loss programs.
Main Outcomes and Measures


The 12-month change in the percentage of interlimb volume difference.
Results


Of 351 participants, 90 were randomized to the control group (facility-based lymphedema care with no home-based exercise or weight loss intervention), 87 to the exercise intervention group, 87 to the weight loss intervention group, and 87 to the combined exercise and weight loss intervention group; 218 (62.1%) were white, 122 (34.8%) were black, and 11 (3.1%) were of other races or ethnicities. Median time since breast cancer diagnosis was 6 years (range, 1-29 years). Mean (SD) total upper extremity score changes from the objective clinical evaluation were -1.40 (11.10) in the control group, -2.54 (13.20) in the exercise group, -3.54 (12.88) in the weight loss group, and -3.84 (10.09) in the combined group. Mean (SD) overall upper extremity score changes from the self-report survey were -0.39 (2.33) in the control group, -0.12 (2.14) in the exercise group, -0.57 (2.47) in the weight loss group, and -0.62 (2.38) in the combined group. Weight loss from baseline was -0.55% (95% CI, -2.22% to 1.11%) in the control group, -8.06% (95% CI, -9.82% to 6.29%) in the combined group, -7.37% (95% CI, -8.90% to -5.84%) in the weight loss group, and -0.44% (95% CI, -1.81% to 0.93%) in the exercise group.
Conclusions and Relevance


Study results indicate that weight loss, home-based exercise, and combined interventions did not improve BCRL outcomes; a supervised facility-based program of exercise may be more beneficial than a home-based program for improving lymphedema outcomes.
Trial Registration


ClinicalTrials.gov identifier: NCT01515124.",2019,"Weight loss from baseline was -0.55% (95% CI, -2.22% to 1.11%) in the control group, -8.06% (95% CI, -9.82% to 6.29%) in the combined group, -7.37% (95% CI,","['351 participants', 'Breast Cancer-Related Lymphedema Outcomes', 'Overweight Breast Cancer Survivors', '351 overweight breast cancer survivors with breast cancer-related lymphedema (BCRL) was conducted in conference rooms at academic and community hospitals and in the homes of participants from March 12, 2012, to May 28, 2016; follow-up was conducted for 1 year from the start of the intervention', 'group; 218 (62.1%) were white, 122 (34.8%) were black, and 11 (3.1%) were of other races or ethnicities', 'overweight breast cancer survivors']","['home-based exercise program of strength/resistance training twice per week and 180 minutes of walking per week, a weight loss program of 20 weeks of meal replacements and 52 weeks of lifestyle modification counseling, and a combination of the home-based exercise and weight loss programs', 'Home-Based Exercise and Weight Loss Programs', 'WISER', 'control group (facility-based lymphedema care with no home-based exercise or weight loss intervention), 87 to the exercise intervention group, 87 to the weight loss intervention group, and 87 to the combined exercise and weight loss intervention']","['Mean (SD) overall upper extremity score changes', 'Weight loss', 'Median time since breast cancer diagnosis', 'Mean (SD) total upper extremity score changes']","[{'cui': 'C4277512', 'cui_str': 'Breast Cancer-Related Arm Lymphedema'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C4517683', 'cui_str': '3.1 (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2960599', 'cui_str': 'Lymphedema care'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",351.0,0.0590946,"Weight loss from baseline was -0.55% (95% CI, -2.22% to 1.11%) in the control group, -8.06% (95% CI, -9.82% to 6.29%) in the combined group, -7.37% (95% CI,","[{'ForeName': 'Kathryn H', 'Initials': 'KH', 'LastName': 'Schmitz', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State College of Medicine, Hershey.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Department of Biostatistics, New York University School of Medicine, New York.'}, {'ForeName': 'Lorraine T', 'Initials': 'LT', 'LastName': 'Dean', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'DeMichele', 'Affiliation': 'Department of Hematology/Oncology, Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Brown', 'Affiliation': 'Department of Population and Public Health Sciences, Pennington Biomedical Research Center, Baton Rouge, Louisiana.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Sturgeon', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State College of Medicine, Hershey.'}, {'ForeName': 'Zi', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Harlem Hospital Center, New York, New York.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Evangelisti', 'Affiliation': 'Department of Hematology/Oncology, Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Spinelli', 'Affiliation': 'Department of Physical Therapy, Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Kallan', 'Affiliation': 'Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Denlinger', 'Affiliation': 'Division of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cheville', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Renate M', 'Initials': 'RM', 'LastName': 'Winkels', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State College of Medicine, Hershey.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Chodosh', 'Affiliation': 'Department of Hematology/Oncology, Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Sarwer', 'Affiliation': 'Department of Social and Behavioral Sciences, Temple University, Philadelphia, Pennsylvania.'}]",JAMA oncology,['10.1001/jamaoncol.2019.2109']
1088,31443887,A pilot study assessing acceptability and feasibility of hatha yoga for chronic pain in people receiving opioid agonist therapy for opioid use disorder.,"The purpose of this project was to assess the feasibility and acceptability of a hatha yoga program designed to target chronic pain in people receiving opioid agonist therapy for opioid use disorder. We conducted a pilot randomized trial in which people with chronic pain who were receiving either methadone maintenance therapy (n = 20) or buprenorphine (n = 20) were randomly assigned to weekly hatha yoga or health education (HE) classes for 3 months. We demonstrated feasibility in many domains, including recruitment of participants (58% female, mean age 43), retention for follow-up assessments, and ability of teachers to provide interventions with high fidelity to the manuals. Fifty percent of participants in yoga (95% CI: 0.28-0.72) and 65% of participants in HE (95% CI: 0.44-0.87) attended at least 6 of 12 possible classes (p = 0.62). Sixty-one percent in the yoga group reported practicing yoga at home, with a mean number of times practicing per week of 2.67 (SD = 2.37). Participant mood improved pre-class to post-class, with greater decreases in anxiety and pain for those in the yoga group (p < 0.05). In conclusion, yoga can be delivered on-site at opioid agonist treatment programs with home practice taken up by the majority of participants. Future research may explore ways of increasing the yoga ""dosage"" received. This may involve testing strategies for increasing either class attendance or the amount of home practice or both.",2019,"Participant mood improved pre-class to post-class, with greater decreases in anxiety and pain for those in the yoga group (p < 0.05).","['n\u202f=\u202f20) or', 'participants (58% female, mean age 43), retention for follow-up assessments, and ability of teachers to provide interventions with high fidelity to the manuals', 'n\u202f=\u202f20', 'people receiving opioid agonist therapy for opioid use disorder', 'people with chronic pain who were receiving either']","['hatha yoga', 'methadone maintenance therapy', 'hatha yoga program', 'hatha yoga or health education (HE) classes for 3\u202fmonths', 'buprenorphine']","['anxiety and pain', 'feasibility and acceptability']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0018701'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.09203,"Participant mood improved pre-class to post-class, with greater decreases in anxiety and pain for those in the yoga group (p < 0.05).","[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Uebelacker', 'Affiliation': 'Butler Hospital, United States of America; Brown University, United States of America. Electronic address: luebelacker@butler.org.'}, {'ForeName': 'Donnell', 'Initials': 'D', 'LastName': 'Van Noppen', 'Affiliation': 'Butler Hospital, United States of America.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Tremont', 'Affiliation': 'Brown University, United States of America; Rhode Island Hospital, United States of America.'}, {'ForeName': 'Genie', 'Initials': 'G', 'LastName': 'Bailey', 'Affiliation': 'Brown University, United States of America; Stanley Street Treatment and Resources, United States of America.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Abrantes', 'Affiliation': 'Butler Hospital, United States of America; Brown University, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stein', 'Affiliation': 'Butler Hospital, United States of America; Brown University, United States of America; Boston University, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.07.015']
1089,31339826,Sustained Progression-Free Survival Benefit of Rituximab Maintenance in Patients With Follicular Lymphoma: Long-Term Results of the PRIMA Study.,"PURPOSE


The PRIMA study (ClinicalTrials.gov identifier: NCT00140582) established that 2 years of rituximab maintenance after first-line immunochemotherapy significantly improved progression-free survival (PFS) in patients with follicular lymphoma compared with observation. Here, we report the final PFS and overall survival (OS) results from the PRIMA study after 9 years of follow-up and provide a final overview of safety.
METHODS


Patients (> 18 years of age) with previously untreated high-tumor-burden follicular lymphoma were nonrandomly assigned to receive one of three immunochemotherapy induction regimens. Responding patients were randomly assigned (stratified by induction regimen, response to induction treatment, treatment center, and geographic region) 1:1 to receive 2 years of rituximab maintenance (375 mg/m 2 , once every 8 weeks), starting 8 weeks after the last induction treatment, or observation (no additional treatment). All patients in the extended follow-up provided their written informed consent (data cutoff: December 31, 2016).
RESULTS


In total, 1,018 patients completed induction treatment and were randomly assigned to rituximab maintenance (n = 505) or observation (n = 513). Consent for the extended follow-up was provided by 607 patients (59.6%) of 1,018 (rituximab maintenance, n = 309; observation, n = 298). After data cutoff, median PFS was 10.5 years in the rituximab maintenance arm compared with 4.1 years in the observation arm (hazard ratio, 0.61; 95% CI, 0.52 to 0.73;  P  < .001). No OS difference was seen in patients randomly assigned to rituximab maintenance or observation (hazard ratio, 1.04; 95% CI, 0.77 to 1.40;  P  = .7948); 10-year OS estimates were approximately 80% in both study arms. No new safety signals were observed.
CONCLUSION


Rituximab maintenance after induction immunochemotherapy provides a significant long-term PFS, but not OS, benefit over observation.",2019,"No OS difference was seen in patients randomly assigned to rituximab maintenance or observation (hazard ratio, 1.04; 95% CI, 0.77 to 1.40;  P  = .7948); 10-year OS estimates were approximately 80% in both study arms.","['Patients With Follicular Lymphoma', 'Patients (> 18 years of age) with previously untreated high-tumor-burden follicular lymphoma', 'patients with follicular lymphoma compared with observation', '1,018 patients completed induction treatment']","['immunochemotherapy induction regimens', 'rituximab maintenance', 'Rituximab Maintenance']","['10-year OS estimates', 'final PFS and overall survival (OS', 'median PFS', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1449699', 'cui_str': 'Tumor Burden'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1018.0,0.177374,"No OS difference was seen in patients randomly assigned to rituximab maintenance or observation (hazard ratio, 1.04; 95% CI, 0.77 to 1.40;  P  = .7948); 10-year OS estimates were approximately 80% in both study arms.","[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Bachy', 'Affiliation': 'Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Institut National de la Santé et de la Recherche Médicale (INSERM) 1052, Pierre-Bénite, France.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Seymour', 'Affiliation': 'Royal Melbourne Hospital and University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Feugier', 'Affiliation': 'Centre Hospitalier Régional Universitaire de Nancy, Université de Lorraine, INSERM 1256, Nancy, France.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Ghent University, Ghent, Belgium.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'López-Guillermo', 'Affiliation': 'Hospital Clinic, Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Belada', 'Affiliation': 'Charles University, Hradec Králové, Czech Republic.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Xerri', 'Affiliation': 'Institut Paoli-Calmettes, Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'John V', 'Initials': 'JV', 'LastName': 'Catalano', 'Affiliation': 'Frankston Hospital and Monash University, Frankston, Victoria, Australia.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Brice', 'Affiliation': 'Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lemonnier', 'Affiliation': 'Hôpitaux Universitaires Henri Mondor, Université Paris-Est Créteil, INSERM U955, Créteil, France.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'Hospital Universitario de Salamanca-Institute for Biomedical Research of Salamanca, Centro de Investigación Biomédica en Red de Cáncer, Salamanca, Spain.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Casasnovas', 'Affiliation': 'Department of Haematology and INSERM 1231, University Hospital F. Mitterrand, Dijon, France.'}, {'ForeName': 'Lars M', 'Initials': 'LM', 'LastName': 'Pedersen', 'Affiliation': 'Herlev University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Dorvaux', 'Affiliation': 'Hôpital de Mercy Centre Hospitalier Régional Metz-Thionville, Metz, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Simpson', 'Affiliation': 'North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Sirpa', 'Initials': 'S', 'LastName': 'Leppa', 'Affiliation': 'Helsinki University Hospital, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Gabarre', 'Affiliation': 'Hôpital Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'da Silva', 'Affiliation': 'Portuguese Institute of Oncology, Lisbon, Portugal.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Glaisner', 'Affiliation': 'Institut Curie-Hôpital Rene Huguenin, Saint-Cloud, France.'}, {'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Ysebaert', 'Affiliation': 'Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Vekhoff', 'Affiliation': 'Saint Antoine Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Tanin', 'Initials': 'T', 'LastName': 'Intragumtornchai', 'Affiliation': 'Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Le Gouill', 'Affiliation': 'Centre Hospitalier Universitaire de Nantes, Centre de Recherche en Cancérologie et Immunologie Nantes Angers, INSERM, Université de Nantes, Nantes, France.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Lister', 'Affiliation': 'Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Estell', 'Affiliation': 'Concord Hospital, Concord, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Milone', 'Affiliation': 'Fundaleu, Buenos Aires, Argentina.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sonet', 'Affiliation': 'UCL, Mont-Godinne, Yvoir, Belgium.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Farhi', 'Affiliation': ""Centre Hospitalier Universitaire d'Angers, Angers, France.""}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Zeuner', 'Affiliation': 'F Hoffman-La Roche, Basel, Switzerland.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Tilly', 'Affiliation': 'Centre Henri-Becquerel, Rouen, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Salles', 'Affiliation': 'Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Institut National de la Santé et de la Recherche Médicale (INSERM) 1052, Pierre-Bénite, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01073']
1090,30862692,Circulating Tumor DNA in HER2-Amplified Breast Cancer: A Translational Research Substudy of the NeoALTTO Phase III Trial.,"PURPOSE


In the neoadjuvant treatment (NAT) setting, dual HER2-targeted therapy is associated with increased pathologic complete response (pCR) rates compared with each therapy alone. Biomarkers allowing to predict treatment response during NAT are needed. We aim to evaluate whether circulating tumor DNA (ctDNA) is associated with response to anti-HER2-targeted therapy.
EXPERIMENTAL DESIGN


Plasma DNA collected before NAT, at week 2, and before surgery from patients enrolled in the NeoALTTO trial was assessed using digital PCR for  PIK3CA  and  TP53  mutation detection.
RESULTS


A total of 69 of 455 (15.2%) patients had a  PIK3CA  and/or  TP53  mutation detected in the baseline tumor sample and evaluable ctDNA results from baseline samples. CtDNA was detected in 41%, 20%, and 5% patients before NAT, at week 2, and before surgery, respectively. ctDNA detection before NAT was significantly associated with older age and ER-negative status. ctDNA detection before NAT was associated with decreased odds of achieving pCR (OR = 0.15; 95% CI, 0.034-0.7;  P  = 0.0089), but not with event-free survival (EFS). Analyses for EFS were underpowered. Interestingly, the patients with HER2-enriched subtype tumors and undetectable ctDNA at baseline had the highest pCR rates. In contrast, patients with persistent ctDNA detection at baseline and week 2 had the lowest rate of pCR.
CONCLUSIONS


ctDNA detection before neoadjuvant anti-HER2 therapies is associated with decreased pCR rates. Interestingly, patients with HER2-enriched tumors and undetectable ctDNA at baseline had the highest pCR rates, therefore appearing as the best candidates for treatment deescalation strategies.",2019,ctDNA detection before NAT was associated with decreased odds of achieving pCR,['HER2-Amplified Breast Cancer'],['circulating tumor DNA (ctDNA'],"['pCR rates', 'CtDNA', 'event-free survival (EFS', 'pathologic complete response (pCR) rates', 'highest pCR rates', 'pCR']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}]","[{'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0734069,ctDNA detection before NAT was associated with decreased odds of achieving pCR,"[{'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Rothé', 'Affiliation': 'Breast Cancer Translational Research Laboratory J.C. Heuson, Institut Jules Bordet, Université Libre de Bruxelles (ULB), U-CRC, Bruxelles, Belgium.'}, {'ForeName': 'Maria Joao', 'Initials': 'MJ', 'LastName': 'Silva', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Venet', 'Affiliation': 'Breast Cancer Translational Research Laboratory J.C. Heuson, Institut Jules Bordet, Université Libre de Bruxelles (ULB), U-CRC, Bruxelles, Belgium.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Campbell', 'Affiliation': 'Frontier Science (Scotland) Ltd, Kingussie, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Bradburry', 'Affiliation': 'Frontier Science (Scotland) Ltd, Kingussie, United Kingdom.'}, {'ForeName': 'Ghizlane', 'Initials': 'G', 'LastName': 'Rouas', 'Affiliation': 'Breast Cancer Translational Research Laboratory J.C. Heuson, Institut Jules Bordet, Université Libre de Bruxelles (ULB), U-CRC, Bruxelles, Belgium.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': 'Medical Oncology Department, Institut Jules Bordet, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Maetens', 'Affiliation': 'Breast Cancer Translational Research Laboratory J.C. Heuson, Institut Jules Bordet, Université Libre de Bruxelles (ULB), U-CRC, Bruxelles, Belgium.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Fumagalli', 'Affiliation': 'Breast International Group (BIG)-aisbl, Bruxelles, Belgium.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Rodrik-Outmezguine', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Di Cosimo', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rosa', 'Affiliation': 'Hospital Moinhos de Vento, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chia', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wardley', 'Affiliation': 'The NIHR Manchester Clinical Research Facility at The Christie NHS Foundation Trust, School of Medical Sciences, Faculty of Biology Medicine & Health, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Kyorin University Hospital, Mitaka, Tokyo, Japan.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Janni', 'Affiliation': 'Universitätsklinikum Ulm, Ulm, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Universitätsklinikum Ulm, Ulm, Germany.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Medical Oncology Department, Institut Jules Bordet, Université Libre de Bruxelles, Bruxelles, Belgium.'}, {'ForeName': 'Sherene', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Sotiriou', 'Affiliation': 'Breast Cancer Translational Research Laboratory J.C. Heuson, Institut Jules Bordet, Université Libre de Bruxelles (ULB), U-CRC, Bruxelles, Belgium.'}, {'ForeName': 'Sarah-Jane', 'Initials': 'SJ', 'LastName': 'Dawson', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, Australia.'}, {'ForeName': 'Michail', 'Initials': 'M', 'LastName': 'Ignatiadis', 'Affiliation': 'Medical Oncology Department, Institut Jules Bordet, Université Libre de Bruxelles, Bruxelles, Belgium. michail.ignatiadis@bordet.be.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-18-2521']
1091,31385378,Sleep restriction does not potentiate nocebo-induced changes in pain and cortical potentials.,"BACKGROUND


The increased pain sensitivity following reduced sleep may be related to changes in cortical processing of nociceptive stimuli. Expectations shape pain perception and can inhibit (placebo) or enhance (nocebo) pain. Sleep restriction appears to enhance placebo responses; however, whether sleep restriction also affects nocebo responses remains unknown. The aim of the present study was to determine whether sleep restriction facilitates nocebo-induced changes in pain and pain-evoked cortical potentials.
METHODS


In an experimental study with a crossover design, the sensitivity to electrically induced pain was determined in 53 nurses under two sleep conditions, after habitual sleep and after two consecutive nights at work. Nocebo was induced by conditioning one-third of the pain stimuli. Pain-elicited cortical event-related potentials were recorded by electroencephalography (EEG). Data were analysed both in the time domain (N2P2 amplitude) and in the time-frequency domain (ERP magnitude). Sleepiness and vigilance were also assessed.
RESULTS


Both nocebo alone and sleep restriction alone increased the sensitivity to electrically induced pain. However, no interaction effect was found. Moreover, the magnitude of the pain-elicited responses increased after sleep restriction and decreased after nocebo expectation, suggesting that nocebo is probably not an underlying mechanism for the commonly observed hyperalgesia induced by sleep restriction.
CONCLUSIONS


The present work addresses whether sleep restriction, known to increase the sensitivity of the pain system, facilitates nocebo-induced hyperalgesia. Our findings suggest that this is not the case, indicating that the increased sensitivity of the pain system following nocebo and sleep restriction are mediated by different cortical mechanisms.",2020,"However, no interaction effect was found.","['53 nurses under two sleep conditions, after habitual sleep and after two consecutive nights at work']",['inhibit (placebo'],"['pain and pain-evoked cortical potentials', 'pain and cortical potentials', 'sensitivity to electrically induced pain', 'Sleepiness and vigilance']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}]",53.0,0.0684744,"However, no interaction effect was found.","[{'ForeName': 'Anbjørn', 'Initials': 'A', 'LastName': 'Ree', 'Affiliation': 'Department of Behavioral Sciences in Medicine, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kristian Bernhard', 'Initials': 'KB', 'LastName': 'Nilsen', 'Affiliation': 'Department of Neurology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Stein', 'Initials': 'S', 'LastName': 'Knardahl', 'Affiliation': 'Department of Work Psychology and Physiology, National Institute of Occupational Health, Oslo, Norway.'}, {'ForeName': 'Trond', 'Initials': 'T', 'LastName': 'Sand', 'Affiliation': 'Department of Neurology and Clinical Neurophysiology, St. Olavs Hospital, Trondheim, Norway.'}, {'ForeName': 'Dagfinn', 'Initials': 'D', 'LastName': 'Matre', 'Affiliation': 'Department of Work Psychology and Physiology, National Institute of Occupational Health, Oslo, Norway.'}]","European journal of pain (London, England)",['10.1002/ejp.1466']
1092,30628526,Core stabilization exercises versus scoliosis-specific exercises in moderate idiopathic scoliosis treatment.,"BACKGROUND


There are several kinds of scoliosis-specific and general physiotherapeutic exercise methods used in scoliosis rehabilitation. But there is need for comparable studies on the effectiveness of different exercise approaches for the treatment of adolescent idiopathic scoliosis.
OBJECTIVES


Comparison of the effects of combined core stabilization exercise and bracing treatment with Scientific Exercises Approach to Scoliosis and bracing treatment in patients with moderate adolescent idiopathic scoliosis.
METHODS


Thirty females with adolescent idiopathic scoliosis, who have moderate curves (20°-45°), were randomly divided into two groups. In addition to brace wearing for 4 months, one group received core stabilization exercise therapy, while the other received scientific exercises approach to scoliosis exercise therapy. The outcome measures were based on Cobb angle, angle of trunk rotation, body symmetry, cosmetic trunk deformity, and quality of life.
RESULTS


Thoracic and lumbar Cobb angles and trunk rotation angles, body symmetry, and cosmetic trunk deformity improved for both groups. Quality of life did not change in either group. The pain domain of the Scoliosis Research Society-22 questionnaire improved in the core stabilization group only.
CONCLUSION


Both treatment conditions including core stabilization with bracing and scientific exercises approach to scoliosis with bracing had similar effects in the short-term treatment of moderate adolescent idiopathic scoliosis.
CLINICAL RELEVANCE


This study showed that when scientific exercises approach to scoliosis (SEAS) and core stabilization (CS) exercises were administered with equal intensity, the effects of the two treatment protocols including CS and bracing and SEAS and bracing were similar in the treatment of patients with moderate adolescent idiopathic scoliosis (AIS).",2019,"The pain domain of the Scoliosis Research Society-22 questionnaire improved in the core stabilization group only.
","['Thirty females with adolescent idiopathic scoliosis, who have moderate curves (20°-45°', 'patients with moderate adolescent idiopathic scoliosis', 'patients with moderate adolescent idiopathic scoliosis (AIS', 'moderate idiopathic scoliosis treatment', 'moderate adolescent idiopathic scoliosis', 'adolescent idiopathic scoliosis']","['combined core stabilization exercise and bracing treatment with Scientific Exercises Approach to Scoliosis and bracing treatment', 'scientific exercises approach to scoliosis exercise therapy', 'Core stabilization exercises versus scoliosis-specific exercises', 'core stabilization exercise therapy', 'scientific exercises approach to scoliosis (SEAS) and core stabilization (CS) exercises']","['Cobb angle, angle of trunk rotation, body symmetry, cosmetic trunk deformity, and quality of life', 'Thoracic and lumbar Cobb angles and trunk rotation angles, body symmetry, and cosmetic trunk deformity', 'Quality of life']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis (disorder)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0595995', 'cui_str': 'Idiopathic scoliosis (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0006086', 'cui_str': 'Braces'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C0563192', 'cui_str': 'Cobb angle (observable entity)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C1404203', 'cui_str': 'Trunk deformities'}, {'cui': 'C0034380'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}]",30.0,0.0187539,"The pain domain of the Scoliosis Research Society-22 questionnaire improved in the core stabilization group only.
","[{'ForeName': 'Gozde', 'Initials': 'G', 'LastName': 'Yagci', 'Affiliation': '1 Faculty of Health Sciences, School of Physical Therapy and Rehabilitation Sciences, Orthotics and Biomechanics Department, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Yakut', 'Affiliation': '2 Physiotherapy and Rehabilitation Department, Hasan Kalyoncu University, Gaziantep, Turkey.'}]",Prosthetics and orthotics international,['10.1177/0309364618820144']
1093,32133668,Home visits by occupational therapists improve adherence to recommendations: Process evaluation of a randomised controlled trial.,"INTRODUCTION


As part of hospital discharge planning, occupational therapists often provide recommendations to improve the interaction between a person and their home environment. The aim of this study was to investigate the number and type of recommendations made by occupational therapists during a home assessment visit compared to hospital-based assessment for patients recovering from hip fracture. A secondary aim was to explore adherence rates to the different types of recommendations.
METHODS


Process evaluation of a randomised controlled trial of 65 participants recovering from hip fracture, returning to community living after hospital discharge. All participants received inpatient multidisciplinary rehabilitation and hospital-based assessment by an occupational therapist (usual care). In addition, the intervention group participated in a single home visit with an occupational therapist prior to hospital discharge. Analysis included the number and type of occupational therapy recommendations, adherence to recommendations at 30 days after discharge, and mediation analysis.
RESULTS


Participants in the home visit group received more recommendations than the usual care group (mean difference [MD] 2.8, 95% CI 1.6 to 3.9) and adhered to a greater proportion of recommendations for assistive technologies (MD 11.4%, 95% CI 2.6 to 20.2) and task modifications (MD 10.0%, 95% CI 0.7 to 19.3). Participants in both groups had lower rates of adherence to recommendations for home modifications compared with other types of recommendations. Adherence to recommendations was a mediator in the relationship between participants' involvement in a pre-discharge home visit and reduced hospital readmissions.
CONCLUSION


There was greater adherence to occupational therapy recommendations when patients recovering from hip fracture participated in a home visit compared to hospital-based assessment, contributing to reduced readmissions to hospital in the first 30 days. Home visits offer additional benefits to hospital-based assessment through the use of a collaborative approach to decision making in the home environment.",2020,"There was greater adherence to occupational therapy recommendations when patients recovering from hip fracture participated in a home visit compared to hospital-based assessment, contributing to reduced readmissions to hospital in the first 30 days.","['patients recovering from hip fracture', '65 participants recovering from hip fracture, returning to community living after hospital discharge']","['single home visit with an occupational therapist prior to hospital discharge', 'inpatient multidisciplinary rehabilitation and hospital-based assessment by an occupational therapist (usual care']","['adherence rates', 'number and type of occupational therapy recommendations, adherence to recommendations', 'proportion of recommendations for assistive technologies']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521108', 'cui_str': 'Recovering from (contextual qualifier) (qualifier value)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist (occupation)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0036605', 'cui_str': 'Assistive Technology'}]",65.0,0.109519,"There was greater adherence to occupational therapy recommendations when patients recovering from hip fracture participated in a home visit compared to hospital-based assessment, contributing to reduced readmissions to hospital in the first 30 days.","[{'ForeName': 'Kylee J', 'Initials': 'KJ', 'LastName': 'Lockwood', 'Affiliation': 'School of Allied Health, Human Services & Sport, La Trobe University, Melbourne, Vic., Australia.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Harding', 'Affiliation': 'School of Allied Health, Human Services & Sport, La Trobe University, Melbourne, Vic., Australia.'}, {'ForeName': 'Jude N', 'Initials': 'JN', 'LastName': 'Boyd', 'Affiliation': 'Department of Occupational Therapy, Eastern Health, Melbourne, Vic., Australia.'}, {'ForeName': 'Nicholas F', 'Initials': 'NF', 'LastName': 'Taylor', 'Affiliation': 'School of Allied Health, Human Services & Sport, La Trobe University, Melbourne, Vic., Australia.'}]",Australian occupational therapy journal,['10.1111/1440-1630.12651']
1094,32441736,Multiple object-tracking isolates feedback-specific load in attention and learning.,"Feedback is beneficial for learning. Nevertheless, it remains unclear whether (i) feedback draws attentional resources when integrated and (ii) the benefits of feedback for learning can be demonstrated using an attention-based task. We therefore (i) isolated feedback-specific load from task-specific load via individual differences in attention resource capacity and (ii) examined the effect of trial-by-trial feedback (i.e., present vs. absent) on learning a multiple object-tracking (MOT) paradigm. We chose MOT because it is a robust measure of attention resource capacity. In Study 1 participants tracked one (i.e., lowest attentional load condition) through four target items (i.e., highest load condition) among eight total items. One group (n = 32) received trial-by-trial feedback whereas the other group (n = 32) did not. The absence of feedback resulted in better MOT performance compared with the presence of feedback. Moreover, the difference in MOT capability between groups increased as the task-specific attentional load increased. These findings suggest that feedback integration requires attentional resources. Study 2 examined whether the absence (n = 19) or presence (n = 19) of feedback affects learning on the same MOT task across four testing days. When holding task-specific load constant, improvement in MOT was greater with feedback than without. Although this study is the first to isolate feedback-specific load in attention with MOT, more evidence is needed to demonstrate how the benefits of feedback translate to improvement on an attention-based task. These findings encourage future research to further explore the interaction between feedback, attention and learning.",2020,"When holding task-specific load constant, improvement in MOT was greater with feedback than without.",[],[],"['MOT', 'task-specific attentional load', 'MOT capability', 'MOT performance']",[],[],"[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",1.0,0.0317721,"When holding task-specific load constant, improvement in MOT was greater with feedback than without.","[{'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Tullo', 'Affiliation': ',.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Perico', 'Affiliation': ',.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Faubert', 'Affiliation': ',.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Bertone', 'Affiliation': ',.'}]",Journal of vision,['10.1167/jov.20.5.9']
1095,32437937,Causes of fever in primary care in Southeast Asia and the performance of C-reactive protein in discriminating bacterial from viral pathogens.,"OBJECTIVES


This study investigated causes of fever in the primary levels of care in Southeast Asia, and evaluated whether C-reactive protein (CRP) could distinguish bacterial from viral pathogens.
METHODS


Blood and nasopharyngeal swab specimens were taken from children and adults with fever (>37.5 °C) or history of fever (<14 days) in Thailand and Myanmar.
RESULTS


Of 773 patients with at least one blood or nasopharyngeal swab specimen collected, 227 (29.4%) had a target organism detected. Influenza virus type A was detected in 85/227 cases (37.5%), followed by dengue virus (30 cases, 13.2%), respiratory syncytial virus (24 cases, 10.6%) and Leptospira spp. (nine cases, 4.0%). Clinical outcomes were similar between patients with a bacterial or a viral organism, regardless of antibiotic prescription. CRP was higher among patients with a bacterial organism compared with those with a viral organism (median 18 mg/L, interquartile range [10-49] versus 10 mg/L [≤8-22], p = 0.003), with an area under the curve of 0.65 (95% CI 0.55-0.75).
CONCLUSIONS


Serious bacterial infections requiring antibiotics are an exception rather than the rule in the first line of care. CRP testing could assist in ruling out such cases in settings where diagnostic uncertainty is high and routine antibiotic prescription is common. The original CRP randomised controlled trial was registered with ClinicalTrials.gov, number NCT02758821.",2020,"CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75).
","['fever in the primary levels of care in Southeast Asia', '773 patients with at least one blood or nasopharyngeal swab specimen collected, 227 (29.4%) had a target organism detected', 'Blood and nasopharyngeal swab specimens were taken from children and adults with fever (>37.5˚C) or history of fever (<14 days) in Thailand and Myanmar']",[],"['respiratory syncytial virus', 'CRP']","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003983', 'cui_str': 'South east Asian country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0006416', 'cui_str': 'Burma'}]",[],"[{'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",773.0,0.237316,"CRP was higher among patients with a bacterial organism compared to those with a viral organism (median 18mg/L, interquartile range [10-49] versus 10mg/L [≤8-22], p-value 0.003), with an area under the curve of 0.65, 95% confidence interval (0.55-0.75).
","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Althaus', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom. Electronic address: thomas.a@tropmedres.ac.'}, {'ForeName': 'Janjira', 'Initials': 'J', 'LastName': 'Thaipadungpanit', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Greer', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Myo Maung Maung', 'Initials': 'MMM', 'LastName': 'Swe', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Myanmar-Oxford Clinical Research Unit (MOCRU), Medical Action Myanmar (MAM), Yangon, Myanmar.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Dittrich', 'Affiliation': 'Foundation for Innovative New Diagnostics (FIND), Geneva, Switzerland.'}, {'ForeName': 'Pimnara', 'Initials': 'P', 'LastName': 'Peerawaranun', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pieter W', 'Initials': 'PW', 'LastName': 'Smit', 'Affiliation': 'Maasstad Ziekenhuis Hospital, Department of Medical Microbiology, Rotterdam, The Netherlands; Public Health Laboratory (GGD), Amsterdam, The Netherlands.'}, {'ForeName': 'Tri', 'Initials': 'T', 'LastName': 'Wangrangsimakul', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Blacksell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Jonas M', 'Initials': 'JM', 'LastName': 'Winchell', 'Affiliation': 'Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Maureen H', 'Initials': 'MH', 'LastName': 'Diaz', 'Affiliation': 'Division of Bacterial Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Nicholas P J', 'Initials': 'NPJ', 'LastName': 'Day', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Smithuis', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Myanmar-Oxford Clinical Research Unit (MOCRU), Medical Action Myanmar (MAM), Yangon, Myanmar.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Turner', 'Affiliation': 'Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom; Cambodia-Oxford Medical Research Unit (COMRU), Angkor Hospital for Children, Siem Reap, Cambodia.'}, {'ForeName': 'Yoel', 'Initials': 'Y', 'LastName': 'Lubell', 'Affiliation': 'Mahidol-Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, United Kingdom.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.05.016']
1096,31436839,Clinical Outcomes of the HIV Protease Inhibitor Nelfinavir With Concurrent Chemoradiotherapy for Unresectable Stage IIIA/IIIB Non-Small Cell Lung Cancer: A Phase 1/2 Trial.,"Importance


Local failure after chemoradiotherapy (CT-RT) significantly contributes to mortality in patients with locally advanced non-small cell lung cancer (LA-NSCLC). One approach to improve local control is through targeted radiosensitization of the tumor.
Objective


To evaluate the dose-limiting toxic effects, maximally tolerated dose, and recommended phase 2 dose of the protease inhibitor nelfinavir mesylate, administered concurrently with CT-RT in patients with LA-NSCLC, and, in the phase 2 portion of the study, to estimate the objective response rate, local and distant failure rates, and overall survival.
Design, Setting, and Participants


This prospective, open-label, single-group, single-institution phase 1/2 trial tested the oral protease inhibitor nelfinavir in combination with concurrent CT-RT in 35 patients aged 18 to 89 years with biopsy-confirmed unresectable stage IIIA/IIIB LA-NSCLC and a minimum Karnofsky performance status from June 29, 2007, to February 22, 2012, with an analysis date of May 9, 2017. Median follow-up for all patients was 6.8 years, with a minimum 5 years of follow-up for all survivors.
Interventions


Oral nelfinavir mesylate, 625 mg, twice daily or 1250 mg, twice daily was administered for 7 to 14 days before and during concurrent CT-RT.
Main Outcomes and Measures


Graded toxic effects, overall survival, local failure, distant failure, objective response rate, and progression-free survival as measured by Response Evaluation Criteria in Solid Tumors, version 1.1.
Results


Thirty-five patients (16 women and 19 men; median age, 60 years [range, 39-79 years]) enrolled and met protocol-specified criteria for adherence, with 5 at a dose of 625 mg twice daily and 30 at a dose of 1250 mg twice daily. No dose-limiting toxic effects were observed. No grade 4 or higher nonhematologic toxic effects were observed. Thirty-three of the 35 patients had evaluable posttreatment computed tomographic scans, with an objective response rate of 94% (31 of 33; 95% CI, 86%-100%). The cumulative incidence of local failure was 39% (95% CI, 30.5%-47.5%). Median progression-free survival was 11.7 months (95% CI, 6.2-17.1 months). Median overall survival for all patients was 41.1 months (95% CI, 19.0-63.1 months); the 5-year mean (SE) overall survival rate was 37.1% (8.2%).
Conclusions and Relevance


This study suggests that nelfinavir administered with concurrent CT-RT is associated with acceptable toxic effects and a promising objective response rate, local failure, progression-free survival, and overall survival in unresectable LA-NSCLC. These data suggest that nelfinavir may enhance the efficacy of standard CT-RT in this disease. Additional testing in the randomized phase 3 setting should be conducted to establish the improvement associated with nelfinavir with concurrent CT-RT.
Trial Registration


ClinicalTrials.gov identifier: NCT00589056.",2019,"The cumulative incidence of local failure was 39% (95% CI, 30.5%-47.5%).","['35 patients aged 18 to 89 years with biopsy-confirmed unresectable stage IIIA/IIIB LA-NSCLC and a minimum Karnofsky performance status from June 29, 2007, to February 22, 2012, with an analysis date of May 9, 2017', 'Unresectable Stage IIIA/IIIB', 'Non-Small Cell Lung Cancer', 'Thirty-five patients (16 women and 19 men; median age, 60 years [range, 39-79 years]) enrolled and met protocol-specified criteria for adherence, with 5 at a dose of 625 mg twice daily and 30 at a dose of 1250 mg twice daily', 'patients with locally advanced non-small cell lung cancer (LA-NSCLC']","['nelfinavir with concurrent CT-RT', 'chemoradiotherapy (CT-RT', 'nelfinavir mesylate', 'protease inhibitor nelfinavir mesylate', 'nelfinavir', 'CT-RT', 'oral protease inhibitor nelfinavir in combination with concurrent CT-RT', 'HIV Protease Inhibitor Nelfinavir With Concurrent Chemoradiotherapy']","['objective response rate, local and distant failure rates, and overall survival', 'Graded toxic effects, overall survival, local failure, distant failure, objective response rate, and progression-free survival', 'cumulative incidence of local failure', '5-year mean (SE) overall survival rate', 'Median overall survival', 'objective response rate', 'objective response rate, local failure, progression-free survival, and overall survival', 'Median progression-free survival', 'nonhematologic toxic effects']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0457162', 'cui_str': 'Stage IIIa'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky Scale'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C4319605', 'cui_str': 'Thirty-five'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0525005', 'cui_str': 'Nelfinavir'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0886530', 'cui_str': 'Nelfinavir Mesylate'}, {'cui': 'C1268897', 'cui_str': 'Product containing protease inhibitor'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0162714', 'cui_str': 'HIV Protease Inhibitors'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",35.0,0.386916,"The cumulative incidence of local failure was 39% (95% CI, 30.5%-47.5%).","[{'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Rengan', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania School of Medicine, Philadelphia.'}, {'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Mick', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, University of Pennsylvania School of Medicine, Philadelphia.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Pryma', 'Affiliation': 'Division of Nuclear Medicine and Clinical Molecular Imaging, Department of Radiology, University of Pennsylvania School of Medicine, Philadelphia.'}, {'ForeName': 'Lilie Leming', 'Initials': 'LL', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Christodouleas', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania School of Medicine, Philadelphia.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Plastaras', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania School of Medicine, Philadelphia.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Simone', 'Affiliation': 'Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Anjali K', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania School of Medicine, Philadelphia.'}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Evans', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, University of Pennsylvania School of Medicine, Philadelphia.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Stevenson', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Corey J', 'Initials': 'CJ', 'LastName': 'Langer', 'Affiliation': 'Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kucharczuk', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, University of Pennsylvania School of Medicine, Philadelphia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Friedberg', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, University of Maryland School of Medicine, Baltimore.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Lam', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania School of Medicine, Philadelphia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Patsch', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania School of Medicine, Philadelphia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Hahn', 'Affiliation': 'Department of Radiation Oncology, MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Maity', 'Affiliation': 'Department of Radiation Oncology, University of Pennsylvania School of Medicine, Philadelphia.'}]",JAMA oncology,['10.1001/jamaoncol.2019.2095']
1097,31435653,The Efficacy of Ultrasonic Bone Scalpel for Unilateral Cervical Open-Door Laminoplasty: A Randomized Controlled Trial.,"BACKGROUND


In cervical open-door laminoplasty for cervical myelopathy, a high-speed rotatory drill and rongeurs are used to make unicortical troughs and bicortical openings in the laminae. The lamina is reflected at the trough to enlarge the spinal canal, followed by bone healing on the hinge side to stabilize laminoplasty. The ultrasonic bone scalpel (UBS) has been used due to theoretical advantages including a better hinge union rate, less soft tissue trauma, less neurological injury, and shorter operative time.
OBJECTIVE


To assess the superiority of UBS for hinge union compared to the drill through randomized controlled trial.
METHODS


In 190 randomly allocated cervical myelopathy patients, the trough and opening at the lamina were made using either the drill (n = 95) or UBS (n = 95) during 2015 to 2018. The primary outcome was the hinge union rate on 6-mo postoperative computed tomography. Secondary outcomes included the hinge union rate at 12 mo, the operative time, intraoperative/postoperative bleeding, neurological injury, complications, and clinical outcomes over a 24-mo follow-up.
RESULTS


Hinge union in all laminae was achieved in 60.0% (drill) and 43.9% (UBS) of patients at 6 mo (intention-to-treat analysis; P = .02; odds ratio, 2.1) and in 91.9% (drill) and 86.5% (UBS) at 12 mo. Dural injury only occurred in the drill group (2.1%), and the UBS group showed significantly less intraoperative bleeding (P < .01). The other secondary outcomes did not differ between groups.
CONCLUSION


The hinge union rate was inferior in the UBS group at 6 mo postoperatively, but UBS was efficacious in reducing dural injuries and bleeding.",2020,"The hinge union rate was inferior in the UBS group at 6 mo postoperatively, but UBS was efficacious in reducing dural injuries and bleeding.",['Unilateral Cervical Open-Door Laminoplasty'],"['Ultrasonic Bone Scalpel', 'UBS', 'ultrasonic bone scalpel (UBS']","['intraoperative bleeding', 'hinge union rate', 'hinge union rate on 6-mo postoperative computed tomography', 'dural injuries and bleeding', 'hinge union rate at 12 mo, the operative time, intraoperative/postoperative bleeding, neurological injury, complications, and clinical outcomes over a 24-mo follow-up', 'Dural injury']","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0557698', 'cui_str': 'Door (physical object)'}, {'cui': 'C1535956', 'cui_str': 'Laminoplasty'}]","[{'cui': 'C1456803', 'cui_str': 'Ultrasonics'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0392220', 'cui_str': 'Surgical knife, device (physical object)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0457406', 'cui_str': 'Hinge (physical object)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0751792', 'cui_str': 'Injuries, Nervous System'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",190.0,0.0860595,"The hinge union rate was inferior in the UBS group at 6 mo postoperatively, but UBS was efficacious in reducing dural injuries and bleeding.","[{'ForeName': 'Chi Heon', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Chun Kee', 'Initials': 'CK', 'LastName': 'Chung', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Yunhee', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Division of Medical Statistics, Medical Research Collaborating Center, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Calvin C', 'Initials': 'CC', 'LastName': 'Kuo', 'Affiliation': 'Regional Spine Surgery Department, Kaiser Permanente, Oakland, California.'}, {'ForeName': 'Urim', 'Initials': 'U', 'LastName': 'Lee', 'Affiliation': 'Human Brain Function Laboratory, Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Seung Heon', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Chang-Hyun', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jong-Myung', 'Initials': 'JM', 'LastName': 'Jung', 'Affiliation': 'Department of Neurosurgery, Seoul National University Bundang Hospital, Kyung-gi, South Korea.'}, {'ForeName': 'Sung Hwan', 'Initials': 'SH', 'LastName': 'Hwang', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Dong Hwan', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Joon Ho', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Seoi', 'Initials': 'S', 'LastName': 'Paik', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Hwa Jin', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Sunhyang', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Sung Bae', 'Initials': 'SB', 'LastName': 'Park', 'Affiliation': 'Department of Neurosurgery, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Kyoung-Tae', 'Initials': 'KT', 'LastName': 'Kim', 'Affiliation': 'Department of Neurosurgery, Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Hee-Pyoung', 'Initials': 'HP', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul, South Korea.'}]",Neurosurgery,['10.1093/neuros/nyz301']
1098,32135068,Airway Oscillometry Detects Spirometric-Silent Episodes of Acute Cellular Rejection.,"Rationale:  Acute cellular rejection (ACR) is common during the initial 3 months after lung transplant. Patients are monitored with spirometry and routine surveillance transbronchial biopsies. However, many centers monitor patients with spirometry only because of the risks and insensitivity of transbronchial biopsy for detecting ACR. Airway oscillometry is a lung function test that detects peripheral airway inhomogeneity with greater sensitivity than spirometry. Little is known about the role of oscillometry in patient monitoring after a transplant. Objectives:  To characterize oscillometry measurements in biopsy-proven clinically significant (grade ≥2 ACR) in the first 3 months after a transplant. Methods:  We enrolled 156 of the 209 double lung transplant recipients between December 2017 and March 2019. Weekly outpatient oscillometry and spirometry and surveillance biopsies at Weeks 6 and 12 were conducted at our center. Measurements and Main Results:  Of the 138 patients followed for 3 or more months, 15 patients had 16 episodes of grade 2 ACR (AR2) and 44 patients had 64 episodes of grade 0 ACR (AR0) rejection associated with stable and/or improving spirometry. In 15/16 episodes of AR2, spirometry was stable or improving in the weeks leading to transbronchial biopsy. However, oscillometry was markedly abnormal and significantly different from AR0 ( P  < 0.05), particularly in integrated area of reactance and the resistance between 5 and 19 Hz, the indices of peripheral airway obstruction. By 2 weeks after biopsy, after treatment for AR2, oscillometry in the AR2 group improved and was similar to the AR0 group. Conclusions:  Oscillometry identified physiological changes associated with AR2 that were not discernible by spirometry and is useful for graft monitoring after a lung transplant.",2020,Airway oscillometry (OSc) is a lung function test that detects peripheral airway inhomogeneity with greater sensitivity than spirometry.,['We enrolled 156 of the 209 double lung transplant recipients between December 2017 and March 2019'],[],"['grade 0 rejection associated with stable/improving spirometry (AR0', 'peripheral airway obstruction']","[{'cui': 'C0396599', 'cui_str': 'Double lung transplant (procedure)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],"[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0035015', 'cui_str': 'Rejection'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0001883', 'cui_str': 'Airway Obstruction'}]",156.0,0.0248294,Airway oscillometry (OSc) is a lung function test that detects peripheral airway inhomogeneity with greater sensitivity than spirometry.,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cho', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Joyce K Y', 'Initials': 'JKY', 'LastName': 'Wu', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Daniella Cunha', 'Initials': 'DC', 'LastName': 'Birriel', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Matelski', 'Affiliation': 'Biostatistics Research Unit, and.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Nadj', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'DeHaas', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Xu', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Aloysius B', 'Initials': 'AB', 'LastName': 'Cheung', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Lindsay N', 'Initials': 'LN', 'LastName': 'Woo', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Day', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Cypel', 'Affiliation': 'Toronto Lung Transplant Programme, Multi-Organ Transplant Unit.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Tikkanen', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Clodagh', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Chung-Wai', 'Initials': 'CW', 'LastName': 'Chow', 'Affiliation': 'Division of Respirology, Department of Medicine, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201908-1539OC']
1099,31424481,Outcomes Associated With Clopidogrel-Aspirin Use in Minor Stroke or Transient Ischemic Attack: A Pooled Analysis of Clopidogrel in High-Risk Patients With Acute Non-Disabling Cerebrovascular Events (CHANCE) and Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trials.,"Importance


Dual antiplatelet therapy with clopidogrel and aspirin is effective for secondary prevention after minor ischemic stroke or transient ischemic attack (TIA). Uncertainties remained about the optimal duration of dual antiplatelet therapy for minor stroke or TIA.
Objective


To obtain precise estimates of efficacy and risk of dual antiplatelet therapy after minor ischemic stroke or TIA.
Design, Setting, and Participants


This analysis pooled individual patient-level data from 2 large-scale randomized clinical trials that evaluated clopidogrel-aspirin as a treatment to prevent stroke after a minor stroke or high-risk TIA. The Clopidogrel in High-Risk Patients With Acute Non-Disabling Cerebrovascular Events (CHANCE) trial enrolled patients at 114 sites in China from October 1, 2009, to July 30, 2012. The Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial enrolled patients at 269 international sites from May 28, 2010, to December 19, 2017. Both were followed up for 90 days. Data analysis occurred from November 2018 to May 2019.
Interventions


In the 2 trials, patients with minor stroke or high-risk TIA were randomized to clopidogrel-aspirin or aspirin alone within 12 hours (POINT) or 24 hours (CHANCE) of symptom onset.
Main Outcomes and Measures


The primary efficacy outcome was a major ischemic event (ischemic stroke, myocardial infarction, or death from ischemic vascular causes). The primary safety outcome was major hemorrhage.
Results


The study enrolled 5170 patients (CHANCE) and 4881 patients (POINT). Analysis included individual data from 10 051 patients (5016 in the clopidogrel-aspirin treatment group and 5035 in the control group) with a median age of 63.2 (interquartile range, 55.0-72.9) years; 6106 patients (60.8%) were male. Clopidogrel-aspirin treatment reduced the risk of major ischemic events at 90 days compared with aspirin alone (328 of 5016 [6.5%] vs 458 of 5035 [9.1%]; hazard ratio [HR], 0.70 [95% CI, 0.61-0.81]; P < .001), mainly within the first 21 days (263 of 5016 [5.2%] vs 391 of 5035 [7.8%]; HR, 0.66 [95% CI, 0.56-0.77]; P < .001), but not from day 22 to day 90. No evidence of heterogeneity of treatment outcome across trials or prespecified subgroups was observed. Major hemorrhages were more frequent in the clopidogrel-aspirin group, but the difference was nonsignificant.
Conclusions and Relevance


In this analysis of the POINT and CHANCE trials, the benefit of dual antiplatelet therapy appeared to be confined to the first 21 days after minor ischemic stroke or high-risk TIA.",2019,"Clopidogrel-aspirin treatment reduced the risk of major ischemic events at 90 days compared with aspirin alone (328 of 5016 [6.5%] vs 458 of 5035 [9.1%]; hazard ratio [HR], 0.70 [95% CI, 0.61-0.81]; P < .001), mainly within the first 21 days (263 of 5016 [5.2%] vs 391 of 5035 [7.8%]; HR, 0.66 [95% CI, 0.56-0.77]; P < .001), but not from day 22 to day 90.","['Analysis included individual data from 10\u202f051 patients (5016 in the', '5170 patients (CHANCE) and 4881 patients (POINT', 'treatment group and 5035 in the control group) with a median age of 63.2 (interquartile range, 55.0-72.9) years; 6106 patients (60.8%) were male', 'patients with minor stroke or high-risk TIA', 'High-Risk Patients With Acute Non-Disabling Cerebrovascular Events (CHANCE) trial enrolled patients at 114 sites in China from October 1, 2009, to July 30, 2012', 'New TIA and Minor Ischemic Stroke (POINT) trial enrolled patients at 269 international sites from May 28, 2010, to December 19, 2017']","['aspirin', 'clopidogrel and aspirin', 'clopidogrel-aspirin', 'Clopidogrel-aspirin', 'Clopidogrel-Aspirin', 'Clopidogrel', 'clopidogrel-aspirin or aspirin']","['Major hemorrhages', 'major hemorrhage', 'major ischemic event (ischemic stroke, myocardial infarction, or death from ischemic vascular causes', 'risk of major ischemic events', 'Minor Stroke or Transient Ischemic Attack']","[{'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}]",5170.0,0.147638,"Clopidogrel-aspirin treatment reduced the risk of major ischemic events at 90 days compared with aspirin alone (328 of 5016 [6.5%] vs 458 of 5035 [9.1%]; hazard ratio [HR], 0.70 [95% CI, 0.61-0.81]; P < .001), mainly within the first 21 days (263 of 5016 [5.2%] vs 391 of 5035 [7.8%]; HR, 0.66 [95% CI, 0.56-0.77]; P < .001), but not from day 22 to day 90.","[{'ForeName': 'Yuesong', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jordan J', 'Initials': 'JJ', 'LastName': 'Elm', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Yilong', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Farrant', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, University of California, San Francisco.'}, {'ForeName': 'Xingquan', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Meurer', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Dietrich', 'Affiliation': 'Benefis Health System, Great Falls, Montana.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Dean's Office, Dell Medical School, University of Texas at Austin.""}]",JAMA neurology,['10.1001/jamaneurol.2019.2531']
1100,31424491,Effect of Recombinant Activated Coagulation Factor VII on Hemorrhage Expansion Among Patients With Spot Sign-Positive Acute Intracerebral Hemorrhage: The SPOTLIGHT and STOP-IT Randomized Clinical Trials.,"Importance


Intracerebral hemorrhage (ICH) is a devastating stroke type that lacks effective treatments. An imaging biomarker of ICH expansion-the computed tomography (CT) angiography spot sign-may identify a subgroup that could benefit from hemostatic therapy.
Objective


To investigate whether recombinant activated coagulation factor VII (rFVIIa) reduces hemorrhage expansion among patients with spot sign-positive ICH.
Design, Setting, and Participants


In parallel investigator-initiated, multicenter, double-blind, placebo-controlled randomized clinical trials in Canada (""Spot Sign"" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy [SPOTLIGHT]) and the United States (The Spot Sign for Predicting and Treating ICH Growth Study [STOP-IT]) with harmonized protocols and a preplanned individual patient-level pooled analysis, patients presenting to the emergency department with an acute primary spontaneous ICH and a spot sign on CT angiography were recruited. Data were collected from November 2010 to May 2016. Data were analyzed from November 2016 to May 2017.
Interventions


Eligible patients were randomly assigned 80 μg/kg of intravenous rFVIIa or placebo as soon as possible within 6.5 hours of stroke onset.
Main Outcomes and Measures


Head CT at 24 hours assessed parenchymal ICH volume expansion from baseline (primary outcome) and total (ie, parenchymal plus intraventricular) hemorrhage volume expansion (secondary outcome). The pooled analysis compared hemorrhage expansion between groups by analyzing 24-hour volumes in a linear regression model adjusted for baseline volumes, time from stroke onset to treatment, and trial.
Results


Of the 69 included patients, 35 (51%) were male, and the median (interquartile range [IQR]) age was 70 (59-80) years. Baseline median (IQR) ICH volumes were 16.3 (9.6-39.2) mL in the rFVIIa group and 20.4 (8.6-32.6) mL in the placebo group. Median (IQR) time from CT to treatment was 71 (57-96) minutes, and the median (IQR) time from stroke onset to treatment was 178 (138-197) minutes. The median (IQR) increase in ICH volume from baseline to 24 hours was small in both the rFVIIa group (2.5 [0-10.2] mL) and placebo group (2.6 [0-6.6] mL). After adjustment, there was no difference between groups on measures of ICH or total hemorrhage expansion. At 90 days, 9 of 30 patients in the rFVIIa group and 13 of 34 in the placebo group had died or were severely disabled (P = .60).
Conclusions and Relevance


Among patients with spot sign-positive ICH treated a median of about 3 hours from stroke onset, rFVIIa did not significantly improve radiographic or clinical outcomes.
Trial Registration


ClinicalTrials.gov identifier: NCT01359202 and NCT00810888.",2019,The median (IQR) increase in ICH volume from baseline to 24 hours was small in both the rFVIIa group (2.5 [0-10.2] mL) and placebo group (2.6 [0-6.6] mL).,"['Patients With Spot Sign-Positive Acute Intracerebral Hemorrhage', '69 included patients, 35 (51%) were male, and the median (interquartile range [IQR]) age was 70 (59-80) years', 'patients presenting to the emergency department with an acute primary spontaneous ICH and a spot sign on CT angiography were recruited', 'patients with spot sign-positive ICH']","['Recombinant Activated Coagulation Factor VII', 'ICH expansion-the computed tomography (CT) angiography spot sign', 'placebo', 'recombinant activated coagulation factor VII (rFVIIa', 'intravenous rFVIIa or placebo']","['Hemorrhage Expansion', 'ICH or total hemorrhage expansion', 'Measures\n\n\nHead CT at 24 hours assessed parenchymal ICH volume expansion from baseline (primary outcome) and total (ie, parenchymal plus intraventricular) hemorrhage volume expansion (secondary outcome', 'Baseline median (IQR) ICH volumes', 'median (IQR) increase in ICH volume', 'Median (IQR) time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C1536105', 'cui_str': 'Angiography, CT'}]","[{'cui': 'C4521950', 'cui_str': 'Activated coagulation factor'}, {'cui': 'C0445385', 'cui_str': 'VII'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0534191', 'cui_str': 'recombinant FVIIa'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0202691', 'cui_str': 'Computerized tomography of head'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.519564,The median (IQR) increase in ICH volume from baseline to 24 hours was small in both the rFVIIa group (2.5 [0-10.2] mL) and placebo group (2.6 [0-6.6] mL).,"[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Gladstone', 'Affiliation': 'Division of Neurology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Aviv', 'Affiliation': 'Hurvitz Brain Sciences Program, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Demchuk', 'Affiliation': 'Department of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Neurosciences and Radiology, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Khoury', 'Affiliation': ""Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Heidi J', 'Initials': 'HJ', 'LastName': 'Sucharew', 'Affiliation': ""Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Al-Ajlan', 'Affiliation': 'Department of Neurosciences, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Butcher', 'Affiliation': 'University of New South Wales, Prince of Wales Clinical School, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dar', 'Initials': 'D', 'LastName': 'Dowlatshahi', 'Affiliation': 'Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Gord', 'Initials': 'G', 'LastName': 'Gubitz', 'Affiliation': 'Division of Neurology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'De Masi', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Hall', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gregg', 'Affiliation': 'Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Mamdani', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Shamy', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Richard H', 'Initials': 'RH', 'LastName': 'Swartz', 'Affiliation': 'Division of Neurology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'C Martin', 'Initials': 'CM', 'LastName': 'Del Campo', 'Affiliation': 'Division of Neurology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Cucchiara', 'Affiliation': 'Department of Neurology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Panagos', 'Affiliation': 'Department of Emergency Medicine, Washington University in St Louis, St Louis, Missouri.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Goldstein', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Carrozzella', 'Affiliation': 'Department of Radiology, University of Cincinnati Academic Health Center, Cincinnati, Ohio.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Jauch', 'Affiliation': 'Mission Research Institute, Mission Health System, Asheville, North Carolina.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Broderick', 'Affiliation': 'Department of Neurology, University of Cincinnati Academic Health Center, Cincinnati, Ohio.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Flaherty', 'Affiliation': 'Department of Neurology, University of Cincinnati Academic Health Center, Cincinnati, Ohio.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA neurology,['10.1001/jamaneurol.2019.2636']
1101,32495381,Randomized controlled trial of multi-modular motion-assisted memory desensitization and reconsolidation (3MDR) for male military veterans with treatment-resistant post-traumatic stress disorder.,"OBJECTIVE


To explore the potential efficacy of multi-modular motion-assisted memory desensitization and reprocessing (3MDR) in British military veterans with treatment-resistant service-related PTSD.
METHODS


Exploratory single-blind, randomized, parallel arm, cross-over controlled trial with nested process evaluation to assess fidelity, adherence and factors that influence outcome.
RESULTS


A total of 42 participants (all male) were randomized with 83% retention at 12 weeks and 86% at 26 weeks. The difference in mean Clinician-Administered PTSD Scale for DSM-5 scores between the immediate and delayed 3MDR arms was -9.38 (95% CI -17.33 to -1.44, P = 0.021) at 12 weeks and -3.59 (-14.39 to 7.20, P = 0.513) at 26 weeks when both groups had received 3MDR. The likely effect size of 3MDR was found to be 0.65. Improvements were maintained at 26-week follow-up. 3MDR was found to be acceptable to most, but not all, participants. Several factors that may impact efficacy and acceptability of 3MDR were identified.
CONCLUSION


3MDR is a promising new intervention for treatment-resistant PTSD with emerging evidence of effect.",2020,"(-14.39 to 7.20, p= 0.513) at 26 weeks when both groups had received 3MDR.","['male military veterans with treatment-resistant post-traumatic stress disorder', 'British military veterans with treatment-resistant, service-related PTSD', '42 participants (all male']","['multi-modular motion-assisted memory desensitisation and reconsolidation (3MDR', 'multi-modular motion-assisted memory desensitisation and reprocessing (3MDR', '3MDR']","['3MDR', 'mean Clinician Administered PTSD Scale for DSM-5 scores']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.133104,"(-14.39 to 7.20, p= 0.513) at 26 weeks when both groups had received 3MDR.","[{'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Bisson', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'van Deursen', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hannigan', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kitchiner', 'Affiliation': ""Veterans' NHS Wales, Cardiff and Vale University Health Board, Cardiff, UK.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Barawi', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pickles', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Skipper', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Young', 'Affiliation': 'Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Abbott', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Gelderen', 'Affiliation': 'Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Nijdam', 'Affiliation': ""ARQ Centrum'45, ARQ National Psychotrauma Centre, Diemen, The Netherlands.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vermetten', 'Affiliation': 'Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13200']
1102,31086354,Enhanced nutrient supply and intestinal microbiota development in very low birth weight infants.,"BACKGROUND


Promoting a healthy intestinal microbiota may have positive effects on short- and long-term outcomes in very low birth weight (VLBW; BW < 1500 g) infants. Nutrient supply influences the intestinal microbiota.
METHODS


Fifty VLBW infants were randomized to an intervention group receiving enhanced nutrient supply or a control group. Fecal samples from 45 infants collected between birth and discharge were analyzed using 16S ribosomal RNA (rRNA) amplicon sequencing.
RESULTS


There was considerable individual variation in microbiota development. Microbial richness decreased towards discharge in the controls compared to the intervention group. In the intervention group, there was a greater increase in diversity among moderately/very preterm (MVP, gestational age ≥ 28 weeks) infants and a steeper decrease in relative Staphylococcus abundance in extremely preterm (EP, gestational age < 28 weeks) infants as compared to controls. Relative Bifidobacterium abundance tended to increase more in MVP controls compared to the intervention group. Abundance of pathogens was not increased in the intervention group. Higher relative Bifidobacterium abundance was associated with improved weight gain.
CONCLUSION


Nutrition may affect richness, diversity, and microbiota composition. There was no increase in relative abundance of pathogens among infants receiving enhanced nutrient supply. Favorable microbiota development was associated with improved weight gain.",2019,Microbial richness decreased towards discharge in the controls compared to the intervention group.,"['very low birth weight infants', 'Fifty VLBW infants', '45 infants collected between birth and discharge were analyzed using 16S ribosomal RNA (rRNA) amplicon sequencing', 'very low birth weight (VLBW; BW\u2009<\u20091500\u2009g) infants']",['intervention group receiving enhanced nutrient supply or a control group'],"['diversity', 'Relative Bifidobacterium abundance', 'richness, diversity, and microbiota composition', 'relative Staphylococcus abundance', 'relative abundance of pathogens', 'Abundance of pathogens', 'Enhanced nutrient supply and intestinal microbiota development', 'weight gain', 'Higher relative Bifidobacterium abundance', 'Microbial richness']","[{'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0035702', 'cui_str': 'RNA, Ribosomal, 16S'}, {'cui': 'C0282666', 'cui_str': 'Very Low Birth Weight'}, {'cui': 'C4517582', 'cui_str': '1500'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0038170', 'cui_str': 'Staphylococcus'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiome'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",50.0,0.0651569,Microbial richness decreased towards discharge in the controls compared to the intervention group.,"[{'ForeName': 'Elin W', 'Initials': 'EW', 'LastName': 'Blakstad', 'Affiliation': 'Department of Pediatric and Adolescent Medicine, Akershus University Hospital and Institute for Clinical Medicine, University of Oslo, Campus Ahus, Nordbyhagen, Norway. e.w.blakstad@medisin.uio.no.'}, {'ForeName': 'Katri', 'Initials': 'K', 'LastName': 'Korpela', 'Affiliation': 'Immunobiology Research Programme, Department of Bacteriology and Immunology, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Sindre', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Nakstad', 'Affiliation': 'Department of Pediatric and Adolescent Medicine, Akershus University Hospital and Institute for Clinical Medicine, University of Oslo, Campus Ahus, Nordbyhagen, Norway.'}, {'ForeName': 'Sissel J', 'Initials': 'SJ', 'LastName': 'Moltu', 'Affiliation': 'Department of Neonatal Intensive Care, Division of Pediatric and Adolescent Medicine, Ullevål, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Strømmen', 'Affiliation': 'Department of Neonatal Intensive Care, Division of Pediatric and Adolescent Medicine, Rikshospitalet, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Arild E', 'Initials': 'AE', 'LastName': 'Rønnestad', 'Affiliation': 'Department of Neonatal Intensive Care, Division of Pediatric and Adolescent Medicine, Rikshospitalet, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Brække', 'Affiliation': 'Department of Neonatal Intensive Care, Division of Pediatric and Adolescent Medicine, Ullevål, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Per O', 'Initials': 'PO', 'LastName': 'Iversen', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Willem M', 'Initials': 'WM', 'LastName': 'de Vos', 'Affiliation': 'Immunobiology Research Programme, Department of Bacteriology and Immunology, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Christian A', 'Initials': 'CA', 'LastName': 'Drevon', 'Affiliation': 'Department of Nutrition, Institute of Basic Medical Sciences, Faculty of Medicine, University of Oslo, Oslo, Norway.'}]",Pediatric research,['10.1038/s41390-019-0412-x']
1103,31415003,Randomized Comparison of Gastric Tube Reconstruction With and Without Duodenal Diversion Plus Roux-en-Y Anastomosis After Esophagectomy.,"OBJECTIVE


This prospective randomized phase-II trial examined whether gastric reconstruction with duodenal diversion plus Roux-en-Y anastomosis(RY) minimized gastroduodenal reflux and delayed gastric emptying compared with standard gastric reconstruction.
SUMMARY BACKGROUND DATA


There is no established standard surgical procedure to prevent both gastroduodenal reflux and delayed gastric emptying simultaneously.
METHODS


Sixty patients with thoracic esophageal cancer scheduled to undergo esophagectomy with retrosternal gastric tube reconstruction were randomly allocated to standard gastric reconstruction (non-RY, n = 31) or gastric reconstruction with duodenal diversion plus RY (n = 29) groups. Primary endpoint was quality of life assessed by DAUGS-32 score 1 year after surgery. Secondary endpoints were the extent of postoperative duodenal juice reflux into the gastric tube, postoperative morbidity, endoscopic findings, body weight changes, and nutritional status.
RESULTS


Preoperative clinicopathological characteristics and postoperative morbidity did not differ significantly between groups. However, operation time and blood loss volume were significantly higher in the RY group. Pancreatic amylase concentrations in the gastric conduit on postoperative days 2, 3, and 7 were higher in the non-RY group. Postoperative endoscopic examination showed residual gastric content in 7 of 17 patients in the non-RY group but in none in the RY group (P = 0.012). Quality of life was significantly favorable in the RY group with regard to reflux symptoms and food passage dysfunction. Postoperative body weight changes, serum albumin levels, and peripheral blood lymphocyte counts were not significantly different between groups.
CONCLUSION


Gastric reconstruction with duodenal diversion plus RY is effective in improving both gastroduodenal reflux and delayed gastric emptying.",2020,"Pancreatic amylase concentrations in the gastric conduit on postoperative days 2, 3, and 7 were higher in the non-RY group.",['Sixty patients with thoracic esophageal cancer scheduled to undergo esophagectomy with retrosternal gastric tube reconstruction'],"['Gastric Tube Reconstruction With and Without Duodenal Diversion Plus Roux-en-Y Anastomosis', 'standard gastric reconstruction', 'gastric reconstruction with duodenal diversion plus Roux-en-Y anastomosis(RY', 'standard gastric reconstruction (non-RY, n = 31) or gastric reconstruction with duodenal diversion plus RY']","['quality of life assessed by DAUGS-32 score 1 year after surgery', 'Quality of life', 'gastroduodenal reflux and delayed gastric emptying', 'operation time and blood loss volume', 'Preoperative clinicopathological characteristics and postoperative morbidity', 'extent of postoperative duodenal juice reflux into the gastric tube, postoperative morbidity, endoscopic findings, body weight changes, and nutritional status', 'gastroduodenal reflux and delayed gastric emptying simultaneously', 'Postoperative body weight changes, serum albumin levels, and peripheral blood lymphocyte counts', 'reflux symptoms and food passage dysfunction', 'Pancreatic amylase concentrations', 'residual gastric content']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0442179', 'cui_str': 'Retrosternal (qualifier value)'}, {'cui': 'C2242688', 'cui_str': 'Gastric tube reconstruction'}]","[{'cui': 'C2242688', 'cui_str': 'Gastric tube reconstruction'}, {'cui': 'C0013303', 'cui_str': 'Duodenum'}, {'cui': 'C0185033', 'cui_str': 'Diversion'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0002804', 'cui_str': 'Roux-en-Y Anastomosis'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0450199', 'cui_str': 'Gastroduodenal (qualifier value)'}, {'cui': 'C0740411', 'cui_str': 'Delayed gastric emptying (disorder)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0227306', 'cui_str': 'Duodenal juice (substance)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte Number'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0301812', 'cui_str': 'Pancreatic amylase (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0038352', 'cui_str': 'Stomach Contents'}]",60.0,0.0257535,"Pancreatic amylase concentrations in the gastric conduit on postoperative days 2, 3, and 7 were higher in the non-RY group.","[{'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Yano', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Keijiro', 'Initials': 'K', 'LastName': 'Sugimura', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Miyata', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Motoori', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Omori', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Ohue', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Sakon', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka International Cancer Institute, Osaka, Japan.'}]",Annals of surgery,['10.1097/SLA.0000000000003557']
1104,32176887,Studies Using Randomized Trial Data to Compare Nonrandomized Exposures.,,2020,,[],[],[],[],[],[],,0.0791849,,"[{'ForeName': 'Catharine B', 'Initials': 'CB', 'LastName': 'Stack', 'Affiliation': 'American College of Physicians, Philadelphia, Pennsylvania (C.B.S., A.R.M.).'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Meibohm', 'Affiliation': 'American College of Physicians, Philadelphia, Pennsylvania (C.B.S., A.R.M.).'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Liao', 'Affiliation': 'University of Washington School of Medicine, Seattle, Washington (J.M.L.).'}, {'ForeName': 'Eliseo', 'Initials': 'E', 'LastName': 'Guallar', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health and Johns Hopkins School of Medicine, Baltimore, Maryland (E.G.).'}]",Annals of internal medicine,['10.7326/M20-0071']
1105,31432080,Postsurgical Electrical Stimulation Enhances Recovery Following Surgery for Severe Cubital Tunnel Syndrome: A Double-Blind Randomized Controlled Trial.,"BACKGROUND


Patients with severe cubital tunnel syndrome often have poor functional recovery with conventional surgical treatment. Postsurgical electrical stimulation (PES) has been shown to enhance axonal regeneration in animal and human studies.
OBJECTIVE


To determine if PES following surgery for severe cubital tunnel syndrome would result in better outcomes compared to surgery alone.
METHODS


Patients with severe cubital tunnel syndrome in this randomized, double-blind, placebo-controlled trial were randomized in a 1:2 ratio to the control or stimulation groups. Control patients received cubital tunnel surgery and sham stimulation, whereas patients in the stimulation group received 1-h of 20 Hz PES following surgery. Patients were assessed by a blinded evaluator annually for 3 yr. The primary outcome was motor unit number estimation (MUNE) and secondary outcomes were grip and key pinch strength and McGowan grade and compound muscle action potential.
RESULTS


A total of 31 patients were enrolled: 11 received surgery alone and 20 received surgery and PES. Three years following surgery, MUNE was significantly higher in the PES group (176 ± 23, mean + SE) compared to controls (88 ± 11, P < .05). The mean gain in key pinch strength in the PES group was almost 3 times greater than in the controls (P < .05). Similarly, other functional and physiological outcomes showed significantly greater improvements in the PES group.
CONCLUSION


PES enhanced muscle reinnervation and functional recovery following surgery for severe cubital tunnel syndrome. It may be a clinically useful adjunct to surgery for severe ulnar neuropathy, in which functional recovery with conventional treatment is often suboptimal.",2020,The mean gain in key pinch strength in the PES group was almost 3 times greater than in the controls (P < .05).,"['31 patients were enrolled: 11 received', 'Severe Cubital Tunnel Syndrome', 'Patients with severe cubital tunnel syndrome', 'severe cubital tunnel syndrome']","['Postsurgical electrical stimulation (PES', 'surgery alone and 20 received surgery and PES', 'placebo', '20 Hz PES', 'cubital tunnel surgery and sham stimulation', 'Postsurgical Electrical Stimulation Enhances Recovery Following Surgery']","['motor unit number estimation (MUNE) and secondary outcomes were grip and key pinch strength and McGowan grade and compound muscle action potential', 'mean gain in key pinch strength', 'muscle reinnervation and functional recovery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0206239', 'cui_str': 'Ulnar Nerve Compression, Cubital Tunnel'}]","[{'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0230376', 'cui_str': 'Structure of ulnar tunnel'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0429357', 'cui_str': 'Motor unit number (observable entity)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0600117', 'cui_str': 'Does grip (finding)'}, {'cui': 'C0429272', 'cui_str': 'Key pinch (observable entity)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0522028', 'cui_str': 'Muscle action potential, function (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0231508', 'cui_str': 'Reinnervation (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.555596,The mean gain in key pinch strength in the PES group was almost 3 times greater than in the controls (P < .05).,"[{'ForeName': 'Hollie A', 'Initials': 'HA', 'LastName': 'Power', 'Affiliation': 'Division of Plastic Surgery, Department of Surgery, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morhart', 'Affiliation': 'Division of Plastic Surgery, Department of Surgery, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Jaret L', 'Initials': 'JL', 'LastName': 'Olson', 'Affiliation': 'Division of Plastic Surgery, Department of Surgery, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'K Ming', 'Initials': 'KM', 'LastName': 'Chan', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada.'}]",Neurosurgery,['10.1093/neuros/nyz322']
1106,31427751,"Effects of immunomodulatory drugs on depressive symptoms: A mega-analysis of randomized, placebo-controlled clinical trials in inflammatory disorders.","Activation of the innate immune system is commonly associated with depression. Immunomodulatory drugs may have efficacy for depressive symptoms that are co-morbidly associated with inflammatory disorders. We report a large-scale re-analysis by standardized procedures (mega-analysis) of patient-level data combined from 18 randomized clinical trials conducted by Janssen or GlaxoSmithKline for one of nine disorders (N = 10,743 participants). Core depressive symptoms (low mood, anhedonia) were measured by the Short Form Survey (SF-36) or the Hospital Anxiety and Depression Scale (HADS), and participants were stratified into high (N = 1921) versus low-depressive strata based on baseline ratings. Placebo-controlled change from baseline after 4-16 weeks of treatment was estimated by the standardized mean difference (SMD) over all trials and for each subgroup of trials targeting one of 7 mechanisms (IL-6, TNF-α, IL-12/23, CD20, COX2, BLγS, p38/MAPK14). Patients in the high depressive stratum showed modest but significant effects on core depressive symptoms (SMD = 0.29, 95% CI [0.12-0.45]) and related SF-36 measures of mental health and vitality. Anti-IL-6 antibodies (SMD = 0.8, 95% CI [0.20-1.41]) and an anti-IL-12/23 antibody (SMD = 0.48, 95% CI [0.26-0.70]) had larger effects on depressive symptoms than other drug classes. Adjustments for physical health outcome marginally attenuated the average treatment effect on depressive symptoms (SMD = 0.20, 95% CI: 0.06-0.35), but more strongly attenuated effects on mental health and vitality. Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment. Novel immune-therapeutics can produce antidepressant effects in depressed patients with primary inflammatory disorders that are not entirely explained by treatment-related changes in physical health.",2020,Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment.,"['depressed patients with primary inflammatory disorders', 'for one of nine disorders (N\u2009=\u200910,743 participants']","['Placebo', 'placebo', 'immunomodulatory drugs', 'Janssen or GlaxoSmithKline']","['depressive symptoms', 'Anti-IL-6 antibodies', 'mental health and vitality', 'core depressive symptoms', 'related SF-36 measures of mental health and vitality', 'Core depressive symptoms (low mood, anhedonia', 'Hospital Anxiety and Depression Scale (HADS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1290884', 'cui_str': 'Inflammatory disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}]",,0.398153,Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment.,"[{'ForeName': 'Gayle M', 'Initials': 'GM', 'LastName': 'Wittenberg', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA. gwittenb@its.jnj.com.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Stylianou', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Bangalore, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Jagannatha', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Bangalore, India.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hsu', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Curran', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'ImmunoPsychiatry, Immuno-Inflammation Therapeutic Area Unit, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, La Jolla, CA, USA.'}, {'ForeName': 'Edward T', 'Initials': 'ET', 'LastName': 'Bullmore', 'Affiliation': 'ImmunoPsychiatry, Immuno-Inflammation Therapeutic Area Unit, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, La Jolla, CA, USA.'}]",Molecular psychiatry,['10.1038/s41380-019-0471-8']
1107,32139216,Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement: Results From the DIRECTAVI Trial.,"OBJECTIVES


The aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV).
BACKGROUND


Randomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV.
METHODS


DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty. The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events.
RESULTS


Device success was recorded for 184 of 236 included patients (78.0%). The rate of device success in the direct implantation group (n = 97 [80.2%]) was noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: -4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 19.0% in the direct implantation group; p = 0.70). No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation.
CONCLUSIONS


Direct TAVR without prior BAV was noninferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification. BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519).",2020,"No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation.
",['randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty'],"['new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV', 'TAVI Without Balloon Predilatation [of the Aortic Valve', 'transcatheter aortic valve replacement (TAVR', 'Transcatheter Aortic Valve Implantation', 'Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement']","['device success rate according to Valve Academic Research Consortium-2 criteria', 'BAV to cross the valve', 'Device success', 'BAV', 'Adverse events', 'procedural and 30-day adverse events', 'severe prosthesis-patient mismatch or severe aortic regurgitation', 'rate of device success', 'duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0004708', 'cui_str': 'Balloon Valvotomy'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0396949', 'cui_str': 'Valvuloplasty of aortic valve (procedure)'}, {'cui': 'C3509486', 'cui_str': 'Transcatheter Aortic Valve Implantation'}, {'cui': 'C0003501', 'cui_str': 'Aortic Valve'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0004708', 'cui_str': 'Balloon Valvotomy'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0035168'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003504', 'cui_str': 'Aortic Incompetence'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation (event)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]",236.0,0.0744625,"No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation.
","[{'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Leclercq', 'Affiliation': 'Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France. Electronic address: f-leclercq@chu-montpellier.fr.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Robert', 'Affiliation': 'Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'Mariama', 'Initials': 'M', 'LastName': 'Akodad', 'Affiliation': 'Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France; PhyMedExp, INSERM U1046, CNRS UMR 9214, Montpellier, France.'}, {'ForeName': 'Jean-Christophe', 'Initials': 'JC', 'LastName': 'Macia', 'Affiliation': 'Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gandet', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital of Montpellier, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Delseny', 'Affiliation': 'Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Chettouh', 'Affiliation': 'Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Schmutz', 'Affiliation': 'Department of Cardiology, CHU Nimes, Montpellier University, Nimes, France.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Robert', 'Affiliation': 'St. Pierre Clinic, Perpignan, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Levy', 'Affiliation': 'Millenaire Clinic, Montpellier, France.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Targosz', 'Affiliation': 'Perpignan Hospital, Perpignan, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Maupas', 'Affiliation': 'Franciscaines Clinic, Nimes, France.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France; PhyMedExp, INSERM U1046, CNRS UMR 9214, Montpellier, France.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Marin', 'Affiliation': 'Department of Medical Information, University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Nagot', 'Affiliation': 'Department of Medical Information, University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Albat', 'Affiliation': 'Department of Cardiovascular Surgery, University Hospital of Montpellier, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Lattuca', 'Affiliation': 'Department of Cardiology, CHU Nimes, Montpellier University, Nimes, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'Department of Cardiology, CHU Nimes, Montpellier University, Nimes, France.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.12.006']
1108,32141724,Early- Versus Adult-Onset Schizophrenia as a Predictor of Response to Neuroscience-Informed Cognitive Training.,"BACKGROUND


Developmental stages characterized by greater neural plasticity might be critical periods during which the effects of cognitive training (CT) could theoretically be maximized. However, experiencing a first episode of schizophrenia during childhood or adolescence (ie, early-onset schizophrenia [EOS]) may reduce the brain's ability to benefit from CT. This study examined the effects of EOS versus onset at > 18 years of age (ie, adult-onset schizophrenia [AOS]) as a predictor of response to CT and the relationship between duration of illness and cognitive improvements.
METHODS


This study is a secondary analysis of data from 2 randomized trials that examined the cognitive effects of neuroscience-informed auditory training (AT) exercises in 84 outpatients with schizophrenia (26 EOS, 58 AOS, recruited between 2004 and 2014).
RESULTS


There was a significant effect of time in all cognitive domains (F > 10.22, P < .002). The effect of EOS was significant only for verbal learning and memory (F = 5.79, P = .018). AOS increased the mean change score by 5.70 points in this domain, whereas EOS showed no change (t = -2.280, P = .025). However, the difference between AOS and EOS was no longer statistically significant after control for multiple comparisons. Shorter duration of illness was associated with greater improvement in problem solving in the AOS group (r = -0.27, P = .040).
CONCLUSIONS


Auditory training is effective in improving cognition in both EOS and AOS. Treatment effects in all cognitive domains were similar, with the exception of verbal learning and memory. This result requires replication. Cognitive training provided earlier in the course of the illness results in greater improvements in executive functions.
TRIAL REGISTRATION


ClinicalTrials.gov identifiers: NCT00312962, NCT00694889​​.",2020,"There was a significant effect of time in all cognitive domains (F > 10.22, P < .002).","['84 outpatients with schizophrenia (26 EOS, 58 AOS, recruited between 2004 and 2014', 'versus onset at > 18 years of age (ie, adult-onset schizophrenia [AOS']","['Cognitive training', 'Auditory training', 'neuroscience-informed auditory training (AT) exercises', 'EOS', 'cognitive training (CT', 'Early']","['time in all cognitive domains', 'verbal learning and memory', 'Shorter duration of illness', 'problem solving', 'mean change score', 'AOS and EOS']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0042531', 'cui_str': 'Verbal Learning'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",84.0,0.0583286,"There was a significant effect of time in all cognitive domains (F > 10.22, P < .002).","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Puig', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, Hospital Clínic Barcelona, Villarroel 170, 08036-Spain. opuig@clinic.ub.es.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Loewy', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, California, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Miley', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Ramsay', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Cameron S', 'Initials': 'CS', 'LastName': 'Carter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, Davis, California, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Ragland', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, Davis, California, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Niendam', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California, Davis, California, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.18m12369']
1109,32192407,Ablation of the great saphenous vein with F-care versus Closurefast endovenous radiofrequency therapy: Double-blinded prospective study.,"OBJECTIVES


F-care (endovenous radiofrequency, F Care Systems, Antwerp, Belgium) is a relatively new radiofrequency ablation technique for the treatment of venous insufficiency. There is a lack of published data about F-care in literature. This study aimed to prospectively compare the F-care method with conventional endovenous radiofrequency ablation Closurefast method for the management of incompetent great saphenous veins.
METHODS


Between June 2015 and December 2018, 114 patients with incompetent varicose veins were treated either with the F-care or Closurefast. The pre-, intra-, postprocedural, and follow-up data of the patients were collected and prospectively compared.
RESULTS


The average ablated vein length was 23.1 ± 4 cm in the F-care group and 26.6 ± 4 cm in the Closurefast group ( P  =   0.01). The average procedure time was 17.4 ± 4 min (range: 10-30 min) in the F-care group, and 17.1 ± 3 min (range: 11-27 min) in the Closurefast group ( P  =   0.77). The one-month total occlusion rates in the F-care and Closurefast groups were 96.2% and 98.1%, respectively ( P  =   0.5). The one-year full occlusion rates in the F-care and Closurefast groups were 71.7% and 90.6%, respectively ( P  =   0.013). In both the F-care and Closurefast groups, the venous clinical severity scores declined significantly with no difference between groups. There was no significant difference between adverse events following F-care treatment compared with Closurefast treatment ( P  ≤   0.05).
CONCLUSIONS


The F-care system was as safe and fast, but the one-year closure rate was significantly lower when compared to the other method. There was no significant difference between the adverse effects of both approaches. Further large-scale, multi-center prospective studies with long-term outcomes are required to identify the effectiveness of F-care treatment modality for patients with saphenous vein insufficiency.",2020,,[],['great saphenous vein with F-care versus Closurefast endovenous radiofrequency therapy'],[],[],"[{'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}, {'cui': 'C4704842', 'cui_str': 'Radio-Frequency Therapy'}]",[],,0.0709942,,"[{'ForeName': 'Macit', 'Initials': 'M', 'LastName': 'Bitargil', 'Affiliation': 'Department of Cardiovascular Surgery, Şişli Hamidiye Etfal Research and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Helin E', 'Initials': 'HE', 'LastName': 'Kılıç', 'Affiliation': 'Department of Cardiovascular Surgery, Şişli Hamidiye Etfal Research and Training Hospital, Istanbul, Turkey.'}]",Phlebology,['10.1177/0268355520913389']
1110,32496865,Socioecological determinants of community resource utilisation among low-income women in Mexico City who experienced male-to-female intimate partner violence.,"Women who experience intimate partner violence (IPV) face multiple barriers to seeking help from community resources, but little research has examined the impact of ecological influences on community resource utilisation among women living in low- and middle-income countries. The current study investigated individual-, relationship-, family-, and community-level influences on community resource utilisation among Mexican women experiencing IPV. Using baseline data from 950 women in Mexico City enrolled in a clinic-based randomised controlled trial, multilevel regressions were performed to assess associations between socioecological factors and women's community resource utilisation. 41.3% women used at least one resource. At the individual-level, every additional resource that women were aware of, was associated with a 20% increase in the total number of resources used ( p  < .001). Every additional lethal risk factor was associated with a 5% increase in the total number of resources used ( p  = .004). At the family-level, women who reported having an in-law encourage IPV used 46% more resources ( p  < .001). At the community-level, stronger supportive norms around community resource utilisation was associated with a 6% increase in the total number of resources ( p  = .01). These findings suggest the importance of addressing family and community factors in the broader ecological context of Mexican women's help-seeking behaviours.",2020,Every additional lethal risk factor was associated with a 5% increase in the total number of resources used ( p  = .004).,"['low-income women in Mexico City who experienced male-to-female intimate partner violence', 'Mexican women experiencing IPV', 'Women who experience intimate partner violence (IPV', '950 women in Mexico City enrolled in a clinic', 'women living in low- and middle-income countries']",[],"['total number of resources', 'total number of resources used']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",950.0,0.0384717,Every additional lethal risk factor was associated with a 5% increase in the total number of resources used ( p  = .004).,"[{'ForeName': 'Tiara C', 'Initials': 'TC', 'LastName': 'Willie', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bastida', 'Affiliation': 'Department of Psychiatry, University of California, Davis, CA, USA.'}, {'ForeName': 'Claudia Diaz', 'Initials': 'CD', 'LastName': 'Olavarrieta', 'Affiliation': 'Research Division, Faculty of Medicine, National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Scolese', 'Affiliation': 'Department of Global and Community Health, George Mason University, Fairfax, VA, USA.'}, {'ForeName': 'Paola Abril', 'Initials': 'PA', 'LastName': 'Campos', 'Affiliation': 'Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Falb', 'Affiliation': 'International Rescue Committee, Washington, DC, USA.'}, {'ForeName': 'Jhumka', 'Initials': 'J', 'LastName': 'Gupta', 'Affiliation': 'Department of Global and Community Health, George Mason University, Fairfax, VA, USA.'}]",Global public health,['10.1080/17441692.2020.1775868']
1111,32493872,Effect of Music Therapy on the Chronic Pain and Midterm Quality of Life of Patients after Mechanical Valve Replacement.,"OBJECTIVE


To evaluate the effect of music therapy on the chronic pain and midterm quality of life of patients after mechanical valve replacement.
METHODS


Patients were divided into two groups according to whether or not they received music therapy. The patients in the music group received 30 minutes of music therapy every day for 6 months after the operation. The patients in the control group received standard treatment and had 30 minutes of quiet rest time every day in the same period. The short-form of McGill Pain Questionnaire (SF-MPQ) was used to evaluate the degree of postoperative chronic pain, and the SF-36 was used to evaluate the midterm quality of life of patients.
RESULTS


In terms of the degree of postoperative chronic pain, the score of the pain rating index (PRI) emotional item in the music group was significantly lower than that in the control group. In the evaluation of the postoperative midterm quality of life using the SF-36, the emotional function score in the music group was significantly higher than that in the control group.
CONCLUSION


This study preliminarily showed that music therapy can effectively reduce chronic pain and improve midterm quality of life after surgery.",2020,"In the evaluation of the postoperative midterm quality of life using the SF-36, the emotional function score in the music group was significantly higher than that in the control group.
","['Patients after Mechanical Valve Replacement', 'Patients', 'patients after mechanical valve replacement']","['music therapy', 'standard treatment and had 30 minutes of quiet rest time', 'Music Therapy']","['chronic pain', 'emotional function score', 'chronic pain and midterm quality of life', 'postoperative chronic pain, the score of the pain rating index (PRI) emotional item', 'midterm quality of life', 'Chronic Pain and Midterm Quality of Life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0493251,"In the evaluation of the postoperative midterm quality of life using the SF-36, the emotional function score in the music group was significantly higher than that in the control group.
","[{'ForeName': 'Ze-Wei', 'Initials': 'ZW', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Liang-Wan', 'Initials': 'LW', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Surgery, Union Hospital, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, the Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}]",Annals of thoracic and cardiovascular surgery : official journal of the Association of Thoracic and Cardiovascular Surgeons of Asia,['10.5761/atcs.oa.20-00022']
1112,32499254,The KOMPACT-P study: Knee Osteoarthritis Management with Physiotherapy informed by Acceptance and Commitment Therapy-Pilot study protocol.,"INTRODUCTION


Incidence of total knee arthroplasty (TKA) is projected to rise 276% in 2030, and psychological distress affects up to 42% of people with knee osteoarthritis undergoing TKA, with demonstrated detrimental effects on postoperative outcomes. Few studies have assessed psychological treatment in people awaiting TKA, and these have been psychologist-delivered treatments. No evidence exists regarding psychologically-informed interventions delivered by health professionals currently embedded in TKA clinical pathways. The primary aim of this pilot study is to explore the safety, acceptability and feasibility of the  K nee  O steoarthritis  M anagement with  P hysiotherapy informed by  A cceptance and  C ommitment  T herapy (KOMPACT) approach in people awaiting TKA.
METHODS AND ANALYSIS


51 community-dwelling adults scheduled for a primary TKA at two hospitals will be recruited to this pilot, mixed-methods, prospective randomised controlled trial with assessor blinding. Participants will be randomised in a 1:2 ratio to either usual care (education class) or usual care plus KOMPACT (2 hours 20 min of preoperative physiotherapy informed by Acceptance and Commitment Therapy). Our primary outcome measures are safety (length of stay, complications and psychological health after KOMPACT), acceptability (treatment credibility and qualitative data) and feasibility (recruitment, retention and intervention fidelity) of the KOMPACT approach. Secondary outcomes include health service outcomes, patient-reported physical and psychological outcomes, and physical performance measures. Quantitative data collection was conducted at baseline, 1-2 weeks before TKA, 6 weeks after TKA and 6 months after TKA. Qualitative data collection is 1-2 weeks before TKA. Data analysis will take a quantitative-led approach with triangulation after thematic analysis of the qualitative data.
ETHICS AND DISSEMINATION


This study has full ethics approval (HREC/18/WMEAD/440). Results from this study will be published in peer-reviewed journals and presented at local and international conferences.
TRIAL REGISTRATION NUMBER


Australia New Zealand Clinical Trials Registry (ACTRN12618001867280p).",2020,"A cceptance and  C ommitment  T herapy (KOMPACT) approach in people awaiting TKA.
","['51 community-dwelling adults scheduled for a primary TKA at two hospitals', 'people awaiting TKA']","['cceptance and  C ommitment  T herapy (KOMPACT) approach', 'total knee arthroplasty (TKA', 'usual care (education class) or usual care plus KOMPACT (2\u2009hours 20\u2009min of preoperative physiotherapy informed by Acceptance and Commitment Therapy']","['safety (length of stay, complications and psychological health after KOMPACT), acceptability (treatment credibility and qualitative data) and feasibility (recruitment, retention and intervention fidelity) of the KOMPACT approach', 'health service outcomes, patient-reported physical and psychological outcomes, and physical performance measures', 'safety, acceptability and feasibility of the  K nee']","[{'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.25181,"A cceptance and  C ommitment  T herapy (KOMPACT) approach in people awaiting TKA.
","[{'ForeName': 'Marie K', 'Initials': 'MK', 'LastName': 'March', 'Affiliation': 'Physiotherapy Department, Blacktown Mt Druitt Hospital, Western Sydney Local Health District, Blacktown, New South Wales, Australia Marie.March@health.nsw.gov.au.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Harmer', 'Affiliation': 'Discipline of Physiotherapy, Sydney School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Godfrey', 'Affiliation': ""Department of Health Psychology, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), King's College London, London, United Kingdom.""}, {'ForeName': 'Shruti', 'Initials': 'S', 'LastName': 'Venkatesh', 'Affiliation': 'Renal Supportive Care, Nepean Blue Mountains Local Health District, Penrith, New South Wales, Australia.'}, {'ForeName': 'Bijoy', 'Initials': 'B', 'LastName': 'Thomas', 'Affiliation': 'Orthopaedic Department, Blacktown Mt Druitt Hospital, Western Sydney Local Health District, Blacktown, New South Wales, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dennis', 'Affiliation': 'Discipline of Physiotherapy, Sydney School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-032675']
1113,32501109,Temporary Bridge Plating vs Primary Arthrodesis of the First Tarsometatarsal Joint in Lisfranc Injuries: Randomized Controlled Trial.,"BACKGROUND


Unstable Lisfranc injuries are best treated with anatomic reduction and stable fixation. There are controversies regarding which type of stabilization is best. In the present study, we compared primary arthrodesis of the first tarsometatarsal (TMT) joint to temporary bridge plating in unstable Lisfranc injuries.
METHODS


Forty-eight patients with Lisfranc injuries were included and followed for 2 years. Twenty-four patients were randomized to primary arthrodesis (PA) of the medial 3 TMT joints, whereas 24 patients were randomized to temporary bridge plate (BP) over the first TMT joint and primary arthrodesis of the second and third TMT joints. The main outcome parameter was the American Orthopaedic Foot & Ankle Society (AOFAS) midfoot scale and the secondary outcome parameters were the 36-Item Short Form Health Survey (SF-36) and visual analog scale for pain (VAS pain). Computed tomography (CT) scans pre- and postoperatively were obtained. Radiographs were obtained at follow-ups. Pedobarographic examination was performed at the 2-year follow-up. Twenty-two of 24 patients in the PA and 23/24 in the BP group completed the 2-year follow-up.
RESULTS


The mean AOFAS midfoot score 2 years postoperatively was 89 (SD 9) in the PA group and 85 (SD 15) in the BP group ( P  = .32). There were no significant differences between the groups with regard to SF-36 or VAS pain scores. The alignment of the first metatarsal was better in the BP group than in the PA group measured by the anteroposterior Meary angle ( P  = .04). The PA group had a reduced peak pressure under the fifth metatarsal ( P  = .047). In the BP group, 11/24 patients had radiologic signs of osteoarthritis in the first TMT joint.
CONCLUSION


Both treatment groups had good outcome scores. The first metatarsal was better aligned in the BP group; however, there was a high incidence of radiographic osteoarthritis in this group.
LEVEL OF EVIDENCE


Therapeutic level I, prospective randomized controlled study.",2020,There were no significant differences between the groups with regard to SF-36 or VAS pain scores.,"['Twenty-four patients were randomized to primary arthrodesis (PA) of the medial 3 TMT joints, whereas 24 patients', 'Twenty-two of 24 patients in the PA and 23/24 in the BP group completed the 2-year follow-up', 'Lisfranc Injuries', 'Forty-eight patients with Lisfranc injuries were included and followed for 2 years']","['primary arthrodesis of the first tarsometatarsal (TMT) joint to temporary bridge plating', 'temporary bridge plate (BP) over the first TMT joint and primary arthrodesis of the second and third TMT joints', 'Temporary Bridge Plating vs Primary Arthrodesis']","['peak pressure', 'Therapeutic level', 'mean AOFAS midfoot score', 'SF-36 or VAS pain scores', 'American Orthopaedic Foot & Ankle Society (AOFAS) midfoot scale', 'radiographic osteoarthritis', '36-Item Short Form Health Survey (SF-36) and visual analog scale for pain (VAS pain', 'radiologic signs of osteoarthritis']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003881', 'cui_str': 'Arthrodesis'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0224724', 'cui_str': 'Structure of tarsometatarsal joint'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4523968', 'cui_str': 'Lisfranc injury'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003881', 'cui_str': 'Arthrodesis'}, {'cui': 'C0447821', 'cui_str': 'First tarsometatarsal joint'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0447823', 'cui_str': 'Third tarsometatarsal joint'}]","[{'cui': 'C0445174', 'cui_str': 'Peak pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0932074', 'cui_str': 'Midfoot region of foot'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0220912', 'cui_str': 'signs'}]",48.0,0.0430063,There were no significant differences between the groups with regard to SF-36 or VAS pain scores.,"[{'ForeName': 'Are H', 'Initials': 'AH', 'LastName': 'Stødle', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Kjetil H', 'Initials': 'KH', 'LastName': 'Hvaal', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Helga M', 'Initials': 'HM', 'LastName': 'Brøgger', 'Affiliation': 'Department of Radiology and Nuclear medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Jan Erik', 'Initials': 'JE', 'LastName': 'Madsen', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Elisabeth Ellingsen', 'Initials': 'EE', 'LastName': 'Husebye', 'Affiliation': 'Division of Orthopaedic Surgery, Oslo University Hospital, Oslo, Norway.'}]",Foot & ankle international,['10.1177/1071100720925815']
1114,32497736,Trifluridine/tipiracil plus bevacizumab in patients with untreated metastatic colorectal cancer ineligible for intensive therapy: the randomized TASCO1 study.,"BACKGROUND


We designed an open-label, noncomparative phase II study to assess the safety and efficacy of first-line treatment with trifluridine/tipiracil plus bevacizumab (TT-B) and capecitabine plus bevacizumab (C-B) in untreated patients with unresectable metastatic colorectal cancer (mCRC) who were not candidates for combination with cytotoxic chemotherapies.
PATIENTS AND METHODS


From 29 April 2016 to 29 March 2017, 153 patients were randomly assigned (1:1) to either TT-B (N = 77) or C-B (N = 76). The primary end point was progression-free survival (PFS). The primary PFS analysis was performed after 100 events (radiological progression or death) were observed. Secondary end points included overall survival (OS), quality of life (QoL; QLQ-C30 and QLQ-CR29 questionnaires), and safety.
RESULTS


Median (range) duration of treatment was 7.8 (6.0-9.7) months and 6.2 (4.1-9.1) months in the TT-B and C-B groups, respectively. Median (range) PFS was 9.2 (7.6-11.6) and 7.8 (5.5-10.1) months, respectively. Median (range) OS was 18 (15.2 to NA) and 16.2 (12.5 to NA) months, respectively. QoL questionnaires showed no relevant changes over time for either treatment. Therapies were well tolerated. Patients receiving TT-B had more grade ≥3 neutropenia (47% versus 5% with C-B). Patients receiving C-B had more grade ≥3 hand-foot syndrome (12% versus 0% with TT-B) and grade ≥3 diarrhea (8% versus 1% with TT-B), consistent with the known safety profiles of these agents.
CONCLUSION


TT-B treatment showed promising clinical activity in untreated patients with unresectable mCRC ineligible for intensive therapy, with an acceptable safety profile and no clinically relevant changes in QoL.
CLINICAL TRIAL INFORMATION


NCT02743221 (ClinicalTrials.gov).",2020,Patients receiving TT-B had more grade ≥3 neutropenia (47% vs. 5% with C-B).,"['Patients with Untreated Metastatic Colorectal Cancer Ineligible for Intensive Therapy', 'From 29 April 2016 to 29 March 2017', 'untreated patients with unresectable metastatic colorectal cancer (mCRC) who were not candidates for combination with cytotoxic chemotherapies', '153 patients']","['Trifluridine/Tipiracil plus Bevacizumab', 'trifluridine/tipiracil plus bevacizumab (TT-B) and capecitabine plus bevacizumab (C-B']","['grade ≥3 hand-foot syndrome', 'Median PFS', 'Median OS', 'tolerated', 'overall survival (OS), quality of life (QoL; QLQ-C30 and QLQ-CR29 questionnaires) and safety', '100 events (radiological progression or death', 'clinical activity', 'grade ≥3 diarrhea', 'safety and efficacy', 'grade ≥3 neutropenia', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0304497', 'cui_str': 'Cytotoxic agent'}]","[{'cui': 'C4055631', 'cui_str': 'Tipiracil- and trifluridine-containing product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",153.0,0.0974354,Patients receiving TT-B had more grade ≥3 neutropenia (47% vs. 5% with C-B).,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'University Hospitals Leuven and KU Leuven, Leuven, Belgium. Electronic address: eric.vancutsem@uzleuven.be.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Danielewicz', 'Affiliation': 'Szpitale Wojewodzkie w Gdyni/Gdansk Medical University, Gdynia, Poland.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Saunders', 'Affiliation': 'Christie Hospital NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pfeiffer', 'Affiliation': 'Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Argilés', 'Affiliation': ""Vall d'Hebrón Institute of Oncology and Vall d'Hebrón University Hospital, Barcelona, Spain.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'University Hospital Besançon, Besançon, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Glynne-Jones', 'Affiliation': 'Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'C J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'Amsterdam University Medical Centers, Amsterdam.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Van de Wouw', 'Affiliation': 'VieCuri Medisch Centrum Noord-Limburg, Venlo, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fedyanin', 'Affiliation': 'NN Blokhin National Medical Research Center of Oncology, Moscow, Russia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Stroyakovskiy', 'Affiliation': 'Moscow City Oncology Hospital N62, Moscow, Russia.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kroening', 'Affiliation': 'Schwerpunktpraxis für Haematologie und Onkologie Hasselbachplatz, Magdeburg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Garcia-Alfonso', 'Affiliation': 'Hospital General Universitario Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'University Hospital of Pisa, Department of Oncology, Pisa, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kanehisa', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Egorov', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Aubel', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Amellal', 'Affiliation': 'Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Moiseenko', 'Affiliation': 'Saint-Petersburg Scientific Practical Center for Specialized Medical Care, St Petersburg, Russia.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.024']
1115,32503866,Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach) for improving walking impairment in peripheral artery disease: study protocol for a randomised controlled trial and economic evaluation.,"INTRODUCTION


Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with smoking and diabetes being the strongest risk factors. The most prominent symptom is leg pain while walking, known as intermittent claudication. To improve mobility, first-line treatment for intermittent claudication is supervised exercise programmes, but these remain largely unavailable and economically impractical, which has led to the development of structured home-based exercise programmes. This trial aims to determine the effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise programme, compared with usual care of PAD. It is hypothesised that TeGeCoach improves walking impairment and lowers the need of health care resources that are spent on patients with PAD.
METHODS AND ANALYSIS


The investigators conduct a prospective, pragmatic randomised controlled clinical trial in a health insurance setting. 1760 patients diagnosed with PAD at Fontaine stage II are randomly assigned to either TeGeCoach or care-as-usual. TeGeCoach consists of telemonitored intermittent walking exercise with medical supervision by a physician and telephone health coaching. Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle. The primary outcome is patient reported walking ability based on the Walking Impairment Questionnaire. Secondary outcome measures include quality of life, health literacy and health behaviour. Claims data are used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes are measured at baseline, 12 and 24 months.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from the Medical Association Hamburg. Findings are disseminated through peer-reviewed journals, reports to the funding body, conference presentations and media press releases. Data from this trial are made available to the public and researchers upon reasonable request.NCT03496948 (www.clinicaltrials.gov), Pre-results.",2020,"Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle.","['peripheral artery disease', 'patients with PAD', '1760 patients diagnosed with PAD at Fontaine stage II']","['Telephone health coaching with exercise monitoring using wearable activity trackers (TeGeCoach', 'usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle', 'TeGeCoach or care-as-usual', 'TeGeCoach']","['walking ability based on the Walking Impairment Questionnaire', 'quality of life, health literacy and health behaviour', 'walking impairment']","[{'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}]","[{'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",1760.0,0.109017,"Participants allocated to the usual care group receive information leaflets and can access supervised exercise programmes, physical therapy and a variety of programmes for promoting a healthy lifestyle.","[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Rezvani', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany f.rezvani@uke.de.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Heider', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Bienert', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Brinkmann', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Herbarth', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Kramer', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Steinisch', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Freudenstein', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Terhalle', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Grosse', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Bock', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Posselt', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Beutel', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Reif', 'Affiliation': 'Kaufmännische Krankenkasse, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kirchhoff', 'Affiliation': 'mhplus Krankenkasse, Nürnberg, Bayern, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Neuschwander', 'Affiliation': 'mhplus Krankenkasse, Nürnberg, Bayern, Germany.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Löffler', 'Affiliation': 'mhplus Krankenkasse, Nürnberg, Bayern, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Brunner', 'Affiliation': 'mhplus Krankenkasse, Nürnberg, Bayern, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Dickmeis', 'Affiliation': 'IEM GmbH, Stolberg, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Heidenthal', 'Affiliation': 'IEM GmbH, Stolberg, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Schmitz', 'Affiliation': 'Philips Germany GmbH, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Daniela Patricia', 'Initials': 'DP', 'LastName': 'Chase', 'Affiliation': 'Philips Germany GmbH, Hamburg, Hamburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Seelenmeyer', 'Affiliation': 'Dr Margarete Fischer Bosch Institute of Clinical Pharmacology, Stuttgart, Baden-Württemberg, Germany.'}, {'ForeName': 'Mark Dominik', 'Initials': 'MD', 'LastName': 'Alscher', 'Affiliation': 'Dr Margarete Fischer Bosch Institute of Clinical Pharmacology, Stuttgart, Baden-Württemberg, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Department of Sports Medicine, Hannover Medical School, Hannover, Niedersachsen, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Dirmaier', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Hamburg, Germany.'}]",BMJ open,['10.1136/bmjopen-2019-032146']
1116,32503867,"Study protocol for an international, multicentre stepped-wedge cluster randomised trial to evaluate the impact of a digital antimicrobial stewardship smartphone application.","INTRODUCTION


With the widespread use of electronic health records and handheld electronic devices in hospitals, informatics-based antimicrobial stewardship interventions hold great promise as tools to promote appropriate antimicrobial drug prescribing. However, more research is needed to evaluate their optimal design and impact on quantity and quality of antimicrobial prescribing.
METHODS AND ANALYSIS


Use of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland. Secondary outcomes will include antimicrobial use metrics, clinical and process outcomes. A multicentre stepped-wedge cluster randomised trial will randomise entities defined as wards or specialty regarding time of introduction of the intervention. We will include 36 hospital entities with seven measurement periods in which the primary outcome will be measured in 15 participating patients per time period per cluster. At participating wards, patients of at least 18 years of age using antimicrobials will be included. After a baseline period of 2-week measurements, six periods of 4 weeks will follow in which the intervention is introduced in 6 wards (in three hospitals) until all 36 wards have implemented the intervention. Thereafter, we allow use of the app by everyone, and evaluate the sustainability of the app use 6 months later.
ETHICS AND DISSEMINATION


This protocol has been approved by the institutional review board of each participating centre. Results will be disseminated via media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov registry (NCT03793946). Stage; pre-results.",2020,"METHODS AND ANALYSIS


Use of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland.","['hospitals', 'At participating wards, patients of at least 18 years of age using antimicrobials will be included']","['smartphone-based digital stewardship applications', 'digital antimicrobial stewardship smartphone application']","['antimicrobial use metrics, clinical and process outcomes']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C4505099', 'cui_str': 'Antimicrobial Stewardship'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",15.0,0.275037,"METHODS AND ANALYSIS


Use of smartphone-based digital stewardship applications (apps) with local guideline directed empirical antimicrobial use by physicians will be compared with antimicrobial prescription as per usual as primary outcome in three hospitals in the Netherlands, Sweden and Switzerland.","[{'ForeName': 'R I', 'Initials': 'RI', 'LastName': 'Helou', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Gaud', 'Initials': 'G', 'LastName': 'Catho', 'Affiliation': 'Department of Infectious Diseases, Hopitaux Universitaires de Geneve, Geneva, Switzerland.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Peyravi Latif', 'Affiliation': 'Department of Infectious Diseases, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Mouton', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hulscher', 'Affiliation': 'Scientific Center for Quality of Healthcare (IQ Healthcare), Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Teerenstra', 'Affiliation': 'Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Conly', 'Affiliation': 'Department of Medicine, University of Calgary and Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Benedikt D', 'Initials': 'BD', 'LastName': 'Huttner', 'Affiliation': 'Department of Infectious Diseases, Hopitaux Universitaires de Geneve, Geneva, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tängdén', 'Affiliation': 'Department of Infectious Diseases, Uppsala University Hospital, Uppsala, Sweden.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands a.verbon@erasmusmc.nl.'}]",BMJ open,['10.1136/bmjopen-2019-033640']
1117,32506827,"Safety, Pharmacokinetics, and Pharmacodynamics of TD-0714, a Novel Potent Neprilysin Inhibitor in Healthy Adult and Elderly Subjects.","TD-0714 is an orally active, potent, and selective inhibitor of human neprilysin (NEP) in development for the treatment of chronic heart failure. Oral administration of TD-0714 in rats resulted in dose-dependent and sustained increases in plasma cyclic guanosine monophosphate (cGMP) over 24 hours consistent with NEP target engagement. Randomized, double-blind, placebo controlled, single ascending dose (50-600 mg TD-0714) and multiple ascending dose (10-200 mg TD-0714 q.d. for 14 days) studies were conducted in healthy volunteers. TD-0714 was generally well-tolerated and no serious adverse events or clinically significant effects on vital signs or electrocardiogram parameters were observed. TD-0714 exhibited dose-proportional pharmacokinetics (PKs) with high oral bioavailability, minimal accumulation after once daily dosing, and negligible renal elimination. Pharmacodynamic (PD) responses were observed at all dose levels studied, as reflected by statistically significant increases in plasma cGMP concentrations. The increases in cGMP were significantly above the baseline (~ 50-100%) on day 14 for the entire 24-hour interval indicating that sustained cGMP elevations are achieved at steady-state. Maximal steady-state cGMP response was observed in plasma and urine at doses ≥ 50 mg. The TD-0714 PK-PD relationship and safety profile were similar in elderly vs. younger adult subjects. The TD-0714 PK and PD profiles support further clinical development of TD-0714 and suggest the potential for once-daily administration and predictable exposure in patients with cardiorenal diseases regardless of their renal function.",2020,Pharmacodynamic (PD) responses were observed at all dose levels studied as reflected by statistically significant increases in plasma cGMP concentrations.,"['patients with cardiorenal diseases regardless of their renal function', 'Healthy Adult and Elderly Subjects', 'elderly vs. younger adult subjects', 'healthy volunteers']","['TD-0714', 'selective inhibitor of human neprilysin (hNEP', 'placebo']","['plasma cGMP concentrations', 'TD-0714 PK-PD relationship and safety profile', 'vital signs or electrocardiogram parameters', 'tolerated and no serious adverse events (SAEs', 'cGMP', 'plasma cyclic guanosine monophosphate (cGMP', 'Pharmacodynamic (PD) responses', 'Maximal steady-state cGMP response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155601', 'cui_str': 'Hypertensive heart AND renal disease'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0025250', 'cui_str': 'Lymphocyte antigen CD10'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0018338', 'cui_str': 'Cyclic guanosine monophosphate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.0319265,Pharmacodynamic (PD) responses were observed at all dose levels studied as reflected by statistically significant increases in plasma cGMP concentrations.,"[{'ForeName': 'Jitendra', 'Initials': 'J', 'LastName': 'Kanodia', 'Affiliation': 'Theravance Biopharma US, Inc, San Francisco, California, USA.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Lo', 'Affiliation': 'Theravance Biopharma US, Inc, San Francisco, California, USA.'}, {'ForeName': 'R Michael', 'Initials': 'RM', 'LastName': 'Baldwin', 'Affiliation': 'Theravance Biopharma US, Inc, San Francisco, California, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Colley', 'Affiliation': 'Theravance Biopharma US, Inc, San Francisco, California, USA.'}, {'ForeName': 'Kefei', 'Initials': 'K', 'LastName': 'Zhou', 'Affiliation': 'Theravance Biopharma US, Inc, San Francisco, California, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Bourdet', 'Affiliation': 'Theravance Biopharma US, Inc, San Francisco, California, USA.'}]",Clinical and translational science,['10.1111/cts.12831']
1118,32217273,"Reply to comment on ""Does pectoralis minor stretching provide additional benefit over an exercise program in subacromial pain syndrome? A randomized controlled trial"" in volume 44, December 2019.",,2020,,[],['exercise program'],[],[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]",[],,0.152329,,"[{'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Gutiérrez-Espinoza', 'Affiliation': 'Rehabilitation and Health Research Center. CIRES, Universidad de Las Américas. Santiago, Chile; Physical Therapy Department, Clinical Hospital San Borja Arriaran, Santiago, Chile.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Araya-Quintanilla', 'Affiliation': 'Rehabilitation and Health Research Center. CIRES, Universidad de las Américas, Santiago, Chile; Faculty of Health, Universidad SEK, Santiago, Chile.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Álvarez-Bueno', 'Affiliation': 'Universidad de Castilla-La Mancha, Health and Social Research Center, Cuenca, Spain. Electronic address: Celia.AlvarezBueno@uclm.es.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Cavero-Redondo', 'Affiliation': 'Universidad de Castilla-La Mancha, Health and Social Research Center, Cuenca, Spain.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102127']
1119,31410672,"The application of antimicrobial photodynamic therapy (aPDT, 670 nm) and diode laser (940 nm) as adjunctive approach in the conventional cause-related treatment of chronic periodontal disease: a randomized controlled split-mouth clinical trial.","OBJECTIVES


The aim of the present randomized controlled split-mouth clinical trial is to evaluate the effectiveness of the adjunctive use of photodynamic low-level laser therapy (670 nm), applying methylene blue as photosensitizer, and the effectiveness of a diode laser (940 nm) compared with conventional non-surgical mechanical treatment in a group of patients with chronic periodontal disease.
MATERIALS AND METHODS


Twenty-one patients with moderate to severe periodontal disease with presence of 3 or more quadrants, each containing at least three sites with periodontal pocket depth (PPD) of ≥ 5 mm, were included in the study. Periodontal treatment comprising scaling and root planing (SRP) was accomplished for the whole mouth. Applying a split-mouth design, each quadrant was randomly treated with SRP alone (control group), SRP with diode laser (diode group), and SRP with photodynamic therapy (photodynamic group).
RESULTS


All treatment modalities in this study lead to statistically significant improvements in the evaluated clinical parameters at 3 months and 6 months compared with baseline. There was no statistically significant difference regarding PD and BOP between groups. There was only a tendency for greater reduction of PD in the diode group for deep pockets at 3 months, but not statistically significant.
CONCLUSIONS


After 6 months of evaluation, the high intensity diode laser and the antimicrobial photodynamic therapy have not shown any additional benefits to the conventional periodontal treatment.
CLINICAL RELEVANCE


The diode or photodynamic laser therapy in conjunction with conventional SRP does not seem to be superior in reducing probing depth and bleeding on probing than SRP alone 6 months after treatment. More studies are necessary to prove the actual need of these types of lasers in the periodontal clinical practice.",2020,All treatment modalities in this study lead to statistically significant improvements in the evaluated clinical parameters at 3 months and 6 months compared with baseline.,"['chronic periodontal disease', 'patients with chronic periodontal disease', 'Twenty-one patients with moderate to severe periodontal disease with presence of 3 or more quadrants, each containing at least three sites with periodontal pocket depth (PPD) of ≥\u20095\xa0mm, were included in the study']","['diode laser', 'diode or photodynamic laser therapy', 'SRP alone (control group), SRP with diode laser (diode group), and SRP with photodynamic therapy (photodynamic group', 'high intensity diode laser and the antimicrobial photodynamic therapy', 'Periodontal treatment comprising scaling and root planing (SRP', 'antimicrobial photodynamic therapy (aPDT, 670\xa0nm) and diode laser (940\xa0nm', 'conventional non-surgical mechanical treatment', 'photodynamic low-level laser therapy']","['reduction of PD', 'PD and BOP']","[{'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0031090', 'cui_str': 'Parodontosis'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0031094', 'cui_str': 'Periodontal Pocket'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor Diode Lasers'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085287', 'cui_str': 'Root Planings'}, {'cui': 'C0627220', 'cui_str': 'Ap(5)dT'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C4517905', 'cui_str': '940'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0484065,All treatment modalities in this study lead to statistically significant improvements in the evaluated clinical parameters at 3 months and 6 months compared with baseline.,"[{'ForeName': 'Fotios', 'Initials': 'F', 'LastName': 'Katsikanis', 'Affiliation': 'Department of Preventive Dentistry, Periodontology and Implant Biology Dental School Aristotle University of Thessaloniki, Konitsis 28, 56431, Thessaloniki, Greece. fkatsikanis@gmail.com.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Strakas', 'Affiliation': 'Operative Dentistry Department, Dental School Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Vouros', 'Affiliation': 'Department of Preventive Dentistry, Periodontology and Implant Biology Dental School Aristotle University of Thessaloniki, Konitsis 28, 56431, Thessaloniki, Greece.'}]",Clinical oral investigations,['10.1007/s00784-019-03045-1']
1120,31410676,Evaluation of postoperative sensitivity in restorations with self-adhesive resin: a randomized split-mouth design controlled study.,"OBJECTIVES


To evaluate the postoperative sensitivity of restorations with self-adhesive resin composite (SAC) (Vertise Flow (VER)/Kerr) compared with conventional resin composite with self-etching adhesive (Filtek Z250 (Z250)/3M ESPE; Clearfil SE Bond (CSEB)/Kuraray).
MATERIALS AND METHODS


A randomized, controlled, double-blind, split-mouth, two-arm clinical trial was conducted. Twenty-seven volunteers with third molars indicated for extraction received two deep class I restorations, one with each material. Postoperative sensitivity was measured at 24 h and 15 or 30 days after the restorative procedures using a visual analog scale (VAS). When present, information on the characteristics of the pain was also collected. The data were submitted to the McNemar test (α = 0.05).
RESULTS


Regardless of the time intervals, the postoperative sensitivity was observed in 52% and 48% of the CSEB and VERT groups, respectively (p = 1.000). When the evaluation periods were analyzed, the 15-day evaluation presented the highest occurrence of pain, but of mild intensity, in both groups. All patients with sensitivity reported that the pain was localized and of short duration.
CONCLUSION


Self-adhesive resin composite Vertise Flow and conventional resin composite with a self-etching bonding agent promoted similar response regarding postoperative sensitivity in deep class I cavities. When postoperative sensitivity was present, mild pain was observed, especially after 15 days of the restorative procedure, which decreased over time.
CLINICAL RELEVANCE


Postoperative sensitivity to self-adhesive resin composite (SAC) restorations in deep cavities was comparable with that of conventional restorations with a self-etching bonding agent.",2020,Self-adhesive resin composite Vertise Flow and conventional resin composite with a self-etching bonding agent promoted similar response regarding postoperative sensitivity in deep class I cavities.,"['restorations with self-adhesive resin', 'Twenty-seven volunteers with third molars indicated for extraction received two deep class I restorations, one with each material']","['restorations with self-adhesive resin composite (SAC) (Vertise Flow (VER)/Kerr', 'conventional resin composite with self-etching adhesive (Filtek Z250 (Z250)/3M ESPE; Clearfil SE Bond (CSEB)/Kuraray']","['postoperative sensitivity', 'mild pain', 'Postoperative sensitivity', 'visual analog scale (VAS']","[{'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0449982', 'cui_str': 'Type of restoration (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C3659065', 'cui_str': 'vertise flow'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1100855', 'cui_str': 'Filtek Z250'}, {'cui': 'C1098526', 'cui_str': 'Clearfil SE Bond'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",27.0,0.131362,Self-adhesive resin composite Vertise Flow and conventional resin composite with a self-etching bonding agent promoted similar response regarding postoperative sensitivity in deep class I cavities.,"[{'ForeName': 'Natália Gomes', 'Initials': 'NG', 'LastName': 'de Oliveira', 'Affiliation': 'School of Dentistry, Universidade de Pernambuco-UPE, Av. General Newton Cavalcanti, 1650, Tabatinga, Camaragibe, PE, 54.756-220, Brazil.'}, {'ForeName': 'Alessandra Souza Leão Costa', 'Initials': 'ASLC', 'LastName': 'Lima', 'Affiliation': 'School of Dentistry, Universidade de Pernambuco-UPE, Av. General Newton Cavalcanti, 1650, Tabatinga, Camaragibe, PE, 54.756-220, Brazil.'}, {'ForeName': 'Marina Torreão', 'Initials': 'MT', 'LastName': 'da Silveira', 'Affiliation': 'School of Dentistry, Universidade de Pernambuco-UPE, Av. General Newton Cavalcanti, 1650, Tabatinga, Camaragibe, PE, 54.756-220, Brazil.'}, {'ForeName': 'Pollyana Rodrigues', 'Initials': 'PR', 'LastName': 'de Souza Araújo', 'Affiliation': 'School of Dentistry, Universidade de Pernambuco-UPE, Av. General Newton Cavalcanti, 1650, Tabatinga, Camaragibe, PE, 54.756-220, Brazil.'}, {'ForeName': 'Gabriela Queiroz', 'Initials': 'GQ', 'LastName': 'de Melo Monteiro', 'Affiliation': 'School of Dentistry, Universidade de Pernambuco-UPE, Av. General Newton Cavalcanti, 1650, Tabatinga, Camaragibe, PE, 54.756-220, Brazil. gabriela.queiroz@upe.br.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'de Vasconcelos Carvalho', 'Affiliation': 'School of Dentistry, Universidade de Pernambuco-UPE, Av. General Newton Cavalcanti, 1650, Tabatinga, Camaragibe, PE, 54.756-220, Brazil.'}]",Clinical oral investigations,['10.1007/s00784-019-03046-0']
1121,32497783,Study protocol: Using peer support to aid in prevention and treatment in prediabetes (UPSTART).,"BACKGROUND


There is an urgent need to develop and evaluate effective and scalable interventions to prevent or delay the onset of type 2 diabetes mellitus (T2DM).
METHODS


In this randomized controlled pragmatic trial, 296 adults with prediabetes will be randomized to either a peer support arm or enhanced usual care. Participants in the peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan for the next week to meet their goals. Over six months, peer coaches call their assigned participants weekly to provide support for weekly action steps. In the final 6 months, coaches call participants at least once monthly. Participants in the enhanced usual care arm receive information on local resources and periodic updates on available diabetes prevention programs and resources. Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
RESULTS


At least 296 participants and approximately 75 peer supporters will be enrolled.
DISCUSSION


Despite evidence that healthy lifestyle interventions can improve health behaviors and reduce risk for T2DM, engagement in recommended behavior change is low. This is especially true among racial and ethnic minority and low-income adults. Regular outreach and ongoing support from a peer coach may help participants to initiate and sustain healthy behavior changes to reduce their risk of diabetes.
TRIAL REGISTRATION


The ClinicalTrials.gov registration number is NCT03689530.",2020,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
","['296 adults with prediabetes', 'At least 296 participants and approximately 75 peer supporters will be enrolled']","['peer support arm or enhanced usual care', 'peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan']","['Changes in A1c, weight, waist circumference', 'health behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",296.0,0.0609549,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed.
","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America. Electronic address: mheisler@umich.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kullgren', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, United States of America; University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, United States of America. Electronic address: jkullgre@med.umich.edu.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: caroli@umich.edu.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Stoll', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: scstoll@umich.edu.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Alvarado Nieves', 'Affiliation': 'University of Michigan, Department of Internal Medicine- Metabolism, Endocrinology and Diabetes, United States of America. Electronic address: alvaradc@med.umich.edu.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: deanne.wiley@kp.org.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Sedgwick', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Tali.S.Sedgwick@kp.org.'}, {'ForeName': 'Alyce', 'Initials': 'A', 'LastName': 'Adams', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Alyce.S.Adams@kp.org.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Hedderson', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Monique.m.hedderson@kp.org.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: Eileen.Kim@kp.org.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: megan.rao@kp.org.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Julie.A.Schmittdiel@kp.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106048']
1122,32502882,Continuing versus suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: Impact on adverse outcomes in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)--The BRACE CORONA Trial.,"Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs). Because renin-angiotensin system blockers increase levels of ACE2, a protein that facilitates coronavirus entry into cells, there is concern that these drugs could increase the risk of developing a severe and fatal form of COVID-19. The impact of discontinuing ACEI and ARBs in patients with COVID-19 remains uncertain. DESIGN: BRACE CORONA is a pragmatic, multicenter, randomized, phase IV, clinical trial that aims to enroll around 500 participants at 34 sites in Brazil. Participants will be identified from an ongoing national registry of suspected and confirmed cases of COVID-19. Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19 will be randomized to a strategy of continued ACEI/ARB treatment versus temporary discontinuation for 30 days. The primary outcome is the median days alive and out of the hospital at 30 days. Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels. SUMMARY: BRACE CORONA will evaluate whether the strategy of continued ACEI/ARB therapy compared with temporary discontinuation of these drugs impacts clinical outcomes among patients with COVID-19.",2020,Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs).,"['patients with COVID-19', 'patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs', '500 participants at 34 sites in Brazil', 'hospitalized patients with severe acute respiratory syndrome coronavirus 2', 'patients with COVID-19 remains uncertain', 'Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19']","['suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers', 'Angiotensin-converting enzyme-2 (ACE2']","['progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels', 'median days alive and out of the hospital at 30 days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027059', 'cui_str': 'Myocarditis'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0020546', 'cui_str': 'Hypertensive crisis'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",500.0,0.143314,Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs).,"[{'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA; Brazilian Clinical Research Institute, São Paulo, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil. Electronic address: renato.lopes@dm.duke.edu.""}, {'ForeName': 'Ariane Vieira Scarlatelli', 'Initials': 'AVS', 'LastName': 'Macedo', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil; Santa Casa de São Paulo, São Paulo, Brazil.""}, {'ForeName': 'Pedro Gabriel Melo', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Renata Junqueira', 'Initials': 'RJ', 'LastName': 'Moll-Bernardes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Feldman', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': ""D'Andréa Saba Arruda"", 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': 'Andrea Silvestre', 'Initials': 'AS', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil; Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.""}, {'ForeName': 'Denilson Campos', 'Initials': 'DC', 'LastName': 'de Albuquerque', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Universidade do Estado do Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.""}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Mazza', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Mayara Fraga', 'Initials': 'MF', 'LastName': 'Santos', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Natalia Zerbinatti', 'Initials': 'NZ', 'LastName': 'Salvador', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Olga Ferreira', 'Initials': 'OF', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.002']
1123,32503869,Psychosocial consequences of false positives in the Danish Lung Cancer CT Screening Trial: a nested matched cohort study.,"OBJECTIVES


Lung cancer CT screening can reduce lung cancer mortality, but high false-positive rates may cause adverse psychosocial consequences. The aim was to analyse the psychosocial consequences of false-positive lung cancer CT screening using the lung cancer screening-specific questionnaire, Consequences of Screening in Lung Cancer (COS-LC).
DESIGN AND SETTING


This study was a matched cohort study, nested in the randomised Danish Lung Cancer Screening Trial (DLCST).
PARTICIPANTS


Our study included all 130 participants in the DLCST with positive CT results in screening rounds 2-5, who had completed the COS-LC questionnaire. Participants were split into a true-positive and a false-positive group and were then matched 1:2 with a control group (n=248) on sex, age (±3 years) and the time of screening for the positive CT groups or clinic visit for the control group. The true positives and false positives were also matched 1:2 with participants with negative CT screening results (n=252).
PRIMARY OUTCOMES


Primary outcomes were psychosocial consequences measured at five time points.
RESULTS


False positives experienced significantly more negative psychosocial consequences in seven outcomes at 1 week and in three outcomes at 1 month compared with the control group and the true-negative group (mean ∆ score >0 and p<0.001). True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group. No long-term psychosocial consequences were identified either in false positives or true positives.
CONCLUSIONS


Receiving a false-positive result in lung cancer screening was associated with negative short-term psychosocial consequences. These findings contribute to the evidence on harms of screening and should be taken into account when considering implementation of lung cancer screening programmes.
TRIAL REGISTRATION NUMBER


NCT00496977.",2020,"True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group.","['Our study included all 130 participants in the DLCST with positive CT results in screening rounds 2-5, who had completed the COS-LC questionnaire', 'Participants were split into a true-positive and a false-positive group and were then matched 1:2 with a control group (n=248) on sex, age (±3 years) and the time of screening for the positive CT groups or clinic visit for the control group']",['false-positive lung cancer CT screening'],"['lung cancer mortality', 'psychosocial consequences measured at five time points', 'lung cancer screening', 'Psychosocial consequences of false positives', 'true positives and false positives', 'negative psychosocial consequences', 'false positives or true positives']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]","[{'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0205559', 'cui_str': 'True positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.0269201,"True positives experienced significantly more negative psychosocial consequences in one outcome at 1 week (mean ∆ score 2.86 (95% CI 1.01 to 4.70), p=0.0024) and in five outcomes at 1 month (mean ∆ score >0 and p<0.004) compared with the true-negative group and the control group.","[{'ForeName': 'Jakob Fraes', 'Initials': 'JF', 'LastName': 'Rasmussen', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Volkert', 'Initials': 'V', 'LastName': 'Siersma', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Malmqvist', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark jessica.malmqvist@sund.ku.dk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brodersen', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-034682']
1124,32512184,"Accelerated iTBS treatment applied to the left DLPFC in depressed patients results in a rapid volume increase in the left hippocampal dentate gyrus, not driven by brain perfusion.","BACKGROUND


Accelerated intermittent Theta Burst Stimulation (aiTBS) has been shown to be an effective antidepressant treatment. Although neurobiological changes shortly after this intervention have been reported, whether aiTBS results in structural brain changes must still be determined. Furthermore, it possible that rapid volumetric changes are driven by factors other than neurotrophic processes.
OBJECTIVES


We examined whether possible grey matter volumetric (GMV) increases after aiTBS treatment could be driven by increased brain perfusion, measured by Arterial Spin Labeling (ASL).
METHODS


46 treatment-resistant depressed patients were randomized to receive 20 sessions of active or sham iTBS applied to the left dorsolateral prefrontal cortex. All sessions were delivered over 4 days at 5 sessions per day (trial registration: http://clinicaltrials.gov/show/NCT01832805). Patients were scanned the day before starting stimulation and three days after aiTBS.
RESULTS


There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation. These GMV increases became more pronounced when accounting for changes in cerebral perfusion.
CONCLUSIONS


Active, but not sham, aiTBS, resulted in acute volumetric changes in parts of the left dentate gyrus, suggesting a connection with adult neurogenesis. Furthermore, taking cerebral perfusion measurements into account impacts on detection of the GMV changes. Whether these hippocampal volumetric changes produced by active aiTBS are necessary for long-term clinical improvement remains to be determined.",2020,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.",['46 treatment-resistant depressed patients'],"['Accelerated intermittent Theta Burst Stimulation (aiTBS', '20 sessions of active or sham iTBS']","['Arterial Spin Labeling (ASL', 'left hippocampal GMV']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}]",46.0,0.102893,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Ghent University, Department of Psychiatry and Medical Psychology, Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium; Vrije Universiteit Brussel (VUB), Department of Psychiatry, Universitair Ziekenhuis Brussel (UZBrussel), Laarbeeklaan 101, 1090, Brussels, Belgium; Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands.'}, {'ForeName': 'GuoRong', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing, China. Electronic address: guorongwu@swu.edu.cn.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Columbia University, Department of Psychiatry, New York, NY, USA; Columbia University, Department of Radiology, New York, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.05.015']
1125,32513518,Combinatorial Pharmacogenomic Testing Improves Outcomes for Older Adults With Depression.,"OBJECTIVE


Evaluate the clinical utility of combinatorial pharmacogenomic testing for informing medication selection among older adults who have experienced antidepressant medication failure for major depressive disorder (MDD).
DESIGN


Post hoc analysis of data from a blinded, randomized controlled trial comparing two active treatment arms.
SETTING


Psychiatry specialty and primary care clinics across 60 U.S. community and academic sites.
PARTICIPANTS


Adults age 65 years or older at baseline (n = 206), diagnosed with MDD and inadequate response to at least one medication on the combinatorial pharmacogenomic test report during the current depressive episode.
INTERVENTION


Combinatorial pharmacogenomic testing to inform medication selection (guided-care), compared with treatment as usual (TAU).
OUTCOMES


Mean percent symptom improvement, response rate, and remission rateat week 8, measured using the 17-item Hamilton Depression Rating Scale; medication switching; and comorbidity moderator analysis.
RESULTS


At week 8, symptom improvement was not significantly different for guided-care than for TAU (∆ = 8.1%, t = 1.64, df = 187; p = 0.102); however, guided-care showed significantly improved response (∆ = 13.6%, t = 2.16, df = 187; p = 0.032) and remission (∆ = 12.7%, t = 2.49, df = 189; p = 0.014) relative to TAU. By week 8, more than twice as many patients in guided-care than in TAU were on medications predicted to have no gene-drug interactions (χ 2  = 19.3, df = 2; p <0.001). Outcomes in the guided-care arm showed consistent improvement through the end of the open-design 24-week trial, indicating durability of the effect. Differences in outcomes between arms were not significantly impacted by comorbidities.
CONCLUSIONS


Combinatorial pharmacogenomic test-informed medication selection improved outcomes over TAU among older adults with depression.",2020,"At week 8, symptom improvement was not significantly different for guided-care than for TAU (∆ = 8.1%, t = 1.64, df = 187; p = 0.102); however, guided-care showed significantly improved response (∆ = 13.6%, t = 2.16, df = 187; p = 0.032) and remission (∆ = 12.7%, t = 2.49, df = 189; p = 0.014) relative to TAU.","['older adults with depression', 'older adults who have experienced antidepressant medication failure for major depressive disorder (MDD', 'Psychiatry specialty and primary care clinics across 60 U.S. community and academic sites', 'Older Adults With Depression', 'Adults age 65 years or older at baseline (n\u202f=\u202f206), diagnosed with MDD and inadequate response to at least one medication on the combinatorial pharmacogenomic test report during the current depressive episode']","['combinatorial pharmacogenomic testing', 'Combinatorial PharmacogenomicTesting']","['Mean percent symptom improvement, response rate, and remission rateat', 'symptom improvement', '17-item Hamilton Depression Rating Scale; medication switching; and comorbidity moderator analysis', 'remission']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C2347501', 'cui_str': 'Pharmacogenomic Screening'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}]","[{'cui': 'C2347501', 'cui_str': 'Pharmacogenomic Screening'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.0861888,"At week 8, symptom improvement was not significantly different for guided-care than for TAU (∆ = 8.1%, t = 1.64, df = 187; p = 0.102); however, guided-care showed significantly improved response (∆ = 13.6%, t = 2.16, df = 187; p = 0.032) and remission (∆ = 12.7%, t = 2.49, df = 189; p = 0.014) relative to TAU.","[{'ForeName': 'Brent P', 'Initials': 'BP', 'LastName': 'Forester', 'Affiliation': 'Division of Geriatric Psychiatry (BPF, IV), McLean Hospital, Harvard Medical School, Belmont, MA. Electronic address: bforester@mclean.harvard.edu.'}, {'ForeName': 'Sagar V', 'Initials': 'SV', 'LastName': 'Parikh', 'Affiliation': 'University of Michigan Comprehensive Depression Center and Department of Psychiatry (SVP, JFG), National Network of Depression Centers, Ann Arbor, MI.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Weisenbach', 'Affiliation': 'Stony Brook University, Department of Psychiatry & Behavioral Health (SW), Stony Brook, NY.'}, {'ForeName': 'Olusola', 'Initials': 'O', 'LastName': 'Ajilore', 'Affiliation': 'University of Illinois at Chicago, School of Public Health/Psychiatric Institute (OJ), Chicago, IL.'}, {'ForeName': 'Ipsit', 'Initials': 'I', 'LastName': 'Vahia', 'Affiliation': 'Division of Geriatric Psychiatry (BPF, IV), McLean Hospital, Harvard Medical School, Belmont, MA.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Rothschild', 'Affiliation': 'University of Massachusetts Medical School and UMass Memorial Healthcare (AJR), Worcester, MA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Perelman School of Medicine of the University of Pennsylvania, the Corporal Michael Crescenz VAMC (MET), Philadelphia, PA.'}, {'ForeName': 'Boadie W', 'Initials': 'BW', 'LastName': 'Dunlop', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences (BWD), Atlanta, GA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'DeBattista', 'Affiliation': 'Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences (CDB), Stanford, CA.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Conway', 'Affiliation': ""Washington University School of Medicine, Department of Psychiatry, and the John Cochran Veteran's Administration Hospital (CRC), St. Louis, MO.""}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'The University of Alabama at Birmingham, Department of Psychiatry and School of Medicine (RCS), Birmingham, AL.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Macaluso', 'Affiliation': 'University of Kansas School of Medicine-Wichita, Department of Psychiatry and Behavioral Sciences (MM), Wichita, KS.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Assurex Health, Inc./Myriad Neuroscience (PT, LB), Mason, OH.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Traxler', 'Affiliation': 'Assurex Health, Inc./Myriad Neuroscience (PT, LB), Mason, OH.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Logan', 'Affiliation': 'Myriad Genetics, Inc. (JL, BD), Salt Lake City, UT.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Assurex Health, Inc./Myriad Neuroscience (PT, LB), Mason, OH.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dechairo', 'Affiliation': 'Myriad Genetics, Inc. (JL, BD), Salt Lake City, UT.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Greden', 'Affiliation': 'University of Michigan Comprehensive Depression Center and Department of Psychiatry (SVP, JFG), National Network of Depression Centers, Ann Arbor, MI.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.05.005']
1126,32515246,Novel Insights Into the Effects of Interleukin 6 Antagonism in Non-ST-Segment-Elevation Myocardial Infarction Employing the SOMAscan Proteomics Platform.,"Background Interleukin 6 concentration is associated with myocardial injury, heart failure, and mortality after myocardial infarction. In the Norwegian tocilizumab non-ST-segment-elevation myocardial infarction trial, the first randomized trial of interleukin 6 blockade in myocardial infarction, concentration of both C-reactive protein and troponin T were reduced in the active treatment arm. In this follow-up study, an aptamer-based proteomic approach was employed to discover additional plasma proteins modulated by tocilizumab treatment to gain novel insights into the effects of this therapeutic approach. Methods and Results Plasma from percutaneous coronary intervention-treated patients, 24 in the active intervention and 24 in the placebo-control arm, drawn 48 hours postrandomization were randomly selected for analysis with the SOMAscan assay. Employing slow off-rate aptamers, the relative abundance of 1074 circulating proteins was measured. Proteins identified as being significantly different between groups were subsequently measured by enzyme immunoassay in the whole trial cohort (117 patients) at all time points (days 1-3 [7 time points] and 3 and 6 months). Five proteins identified by the SOMAscan assay, and subsequently confirmed by enzyme immunoassay, were significantly altered by tocilizumab administration. The acute-phase proteins lipopolysaccharide-binding protein, hepcidin, and insulin-like growth factor-binding protein 4 were all reduced during the hospitalization phase, as was the monocyte chemoattractant C-C motif chemokine ligand 23. Proteinase 3, released primarily from neutrophils, was significantly elevated. Conclusions Employing the SOMAscan aptamer-based proteomics platform, 5 proteins were newly identified that are modulated by interleukin 6 antagonism and may mediate the therapeutic effects of tocilizumab in non-ST-segment-elevation myocardial infarction.",2020,"Five proteins identified by the SOMAscan assay, and subsequently confirmed by enzyme immunoassay, were significantly altered by tocilizumab administration.","['percutaneous coronary intervention-treated patients, 24 in the active intervention and 24 in the placebo-control arm, drawn 48\xa0hours postrandomization', 'Non-ST-Segment-Elevation Myocardial Infarction']",['tocilizumab'],"['myocardial infarction, concentration of both C-reactive protein and troponin T']","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C1536221', 'cui_str': 'Non ST segment elevation myocardial infarction'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}]","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}]",5.0,0.0679143,"Five proteins identified by the SOMAscan assay, and subsequently confirmed by enzyme immunoassay, were significantly altered by tocilizumab administration.","[{'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'George', 'Affiliation': 'Department of Clinical Pharmacology University College London London United Kingdom.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Kleveland', 'Affiliation': 'Clinic of Cardiology St Olavs Hospital Trondheim Norway.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Garcia-Hernandez', 'Affiliation': 'Centre for Cardiovascular Genetics Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Palmen', 'Affiliation': 'Centre for Cardiovascular Genetics Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lovering', 'Affiliation': 'Functional Gene Annotation, Preclinical and Fundamental Science Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Wiseth', 'Affiliation': 'Clinic of Cardiology St Olavs Hospital Trondheim Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Aukrust', 'Affiliation': 'K.G. Jebsen Thrombosis Research and Expertise Center University of Tromsø Tromsø Norway.'}, {'ForeName': 'Jorgen', 'Initials': 'J', 'LastName': 'Engmann', 'Affiliation': 'Centre for Cardiovascular Genetics Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Jan Kristian', 'Initials': 'JK', 'LastName': 'Damås', 'Affiliation': 'Centre of Molecular Inflammation Research Department of Clinical and Molecular Medicine NTNU Trondheim Norway.'}, {'ForeName': 'Aroon D', 'Initials': 'AD', 'LastName': 'Hingorani', 'Affiliation': 'Centre for Cardiovascular Genetics Institute of Cardiovascular Science University College London London United Kingdom.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Institute of Clinical Medicine University of Oslo Norway.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Casas', 'Affiliation': 'Institute of Health Informatics University College London London United Kingdom.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Ueland', 'Affiliation': 'K.G. Jebsen Thrombosis Research and Expertise Center University of Tromsø Tromsø Norway.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015628']
1127,32515255,"Correction to: Oxygen Exposure During Cardiopulmonary Resuscitation Is Associated With Cerebral Oxidative Injury in a Randomized, Blinded, Controlled, Preclinical Trial.",,2020,,[],['Oxygen Exposure During Cardiopulmonary Resuscitation'],[],[],"[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}]",[],,0.130556,,[],Journal of the American Heart Association,['10.1161/JAHA.119.014549']
1128,32210370,"Correction: Augmenting extinction learning with D-cycloserine reduces return of fear: a randomized, placebo-controlled fMRI study.",An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,[],"['extinction learning with D-cycloserine', 'placebo']",['return of fear'],[],"[{'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}]",,0.0893736,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ebrahimi', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany. claudia.ebrahimi@charite.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Gechter', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schlagenhauf', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Alfons O', 'Initials': 'AO', 'LastName': 'Hamm', 'Affiliation': 'Department of Biological and Clinical Psychology/Psychotherapy, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0658-3']
1129,32498073,Systematic manipulations of the biological stress systems result in sex-specific compensatory stress responses and negative mood outcomes.,"Women are twice as likely as men to be diagnosed with anxiety and mood disorders. One potential underlying mechanism is sex differences in physiological and psychological responses to stress; however, no studies to date have investigated this proposed mechanism experimentally. In a double-blind, placebo-controlled design, pharmacological challenges were administered to individually suppress the hypothalamic-pituitary-adrenal (HPA) axis, or the sympathetic nervous system (SNS) prior to stress exposure, to investigate sex differences in the resulting cross talk among the physiological and psychological stress responses. Sex-specific compensatory patterns and psychological effects emerged when the stress systems were manipulated. Men demonstrated heightened SNS reactivity to stress when the HPA axis was suppressed, and greater HPA reactivity after SNS suppression. This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects. In women, higher baseline activation (but dampened reactivity to stress) of SNS or HPA was observed when the other system was suppressed. This was coupled with worsened mood in response to stress when either stress system was compromised. Our results indicate that men and women may be differentially sensitive to fluctuations of their stress systems. This might be a potential link that underlies the sexual dimorphism in vulnerability for psychopathology.",2020,"This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects.",[],['placebo'],['HPA reactivity'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0182391,"This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects.","[{'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Ali', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada. nida.ali@mail.mcgill.ca.'}, {'ForeName': 'Jonas P', 'Initials': 'JP', 'LastName': 'Nitschke', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Cory', 'Initials': 'C', 'LastName': 'Cooperman', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Baldwin', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Pruessner', 'Affiliation': 'Faculty of Medicine, McGill Centre for Studies in Aging, McGill University, Montreal, QC, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0726-8']
1130,32499263,"Monitoring patients with acute dyspnoea with a serial focused ultrasound of the heart and the lungs (MODUS): a protocol for a multicentre, randomised, open-label, pragmatic and controlled trial.","INTRODUCTION


Among patients admitted to an emergency department, dyspnoea is one of the most common symptoms. Patients with dyspnoea have high mortality and morbidity. Therefore, novel methods to monitor the patients are warranted. The aim is to investigate whether therapy guided by monitoring patients with acute dyspnoea with serial ultrasound examinations of the heart and the lungs together with standard care can change the severity of dyspnoea compared with treatment guided by standard monitoring alone.
METHODS AND ANALYSIS


The study will be conducted as a multicentre, randomised, pragmatic, open-label and controlled trial where patients admitted with acute dyspnoea to an emergency ward will be randomised into a standard care group and a serial ultrasound group with 103 patients in each. All patients will be examined with an ultrasound of the heart and the lungs upfront. In addition, the patients in the serial ultrasound group will be examined with an ultrasound of the heart and lungs two more times to guide further therapy during the admittance. The primary outcome is a change in dyspnoea on a verbal scale. After discharge, the patients are followed for 1 year to assess the number of readmissions, death and length of hospital stay.
ETHICS AND DISSEMINATION


The trial is conducted in accordance with the Declaration of Helsinki and approved by The Regional Committee on Health Research Ethics for Region Zealand, Denmark (identifier SJ-744). Data handling agreement with participating centres has been made (identifier REG-056-2019). The General Data Protection Regulation and the Danish Data Protection Act will be respected. The results of the trial will be reported in peer-reviewed scientific journals regardless of the outcomes.
TRIAL REGISTRATION NUMBER


NCT04091334.",2020,"After discharge, the patients are followed for 1 year to assess the number of readmissions, death and length of hospital stay.
","['Monitoring patients with acute dyspnoea with a serial focused ultrasound of the heart and the lungs (MODUS', 'Patients with dyspnoea have high mortality and morbidity', 'patients admitted with acute dyspnoea to an emergency ward will be randomised into a standard care group and a serial ultrasound group with 103 patients in each', 'patients with acute dyspnoea with serial ultrasound examinations of the heart and the lungs together with standard care']",[],"['change in dyspnoea on a verbal scale', 'number of readmissions, death and length of hospital stay']","[{'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0743323', 'cui_str': 'Acute dyspnea'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1449955', 'cui_str': 'Modus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0948501', 'cui_str': 'Ultrasound examination'}]",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0722347,"After discharge, the patients are followed for 1 year to assess the number of readmissions, death and length of hospital stay.
","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Arvig', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark doktorarvig@gmail.com.'}, {'ForeName': 'Annmarie T', 'Initials': 'AT', 'LastName': 'Lassen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gæde', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Christian B', 'Initials': 'CB', 'LastName': 'Laursen', 'Affiliation': 'Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-034373']
1131,32501612,"Circulating adhesion molecules and associations with HbA1c, hypertension, nephropathy, and retinopathy in the Treatment Options for type 2 Diabetes in Adolescent and Youth study.","BACKGROUND


The Treatment Options for type 2 Diabetes in Adolescent and Youth study, a randomized clinical trial of three treatments for type 2 diabetes (T2DM) in youth, demonstrated treatment failure (defined as sustained HbA1c ≥8%, or inability to wean insulin after 3 months after acute metabolic decomposition) in over half of the participants. Given that binding of mononuclear cells to vascular endothelium, initiated by cellular adhesion molecules and chemokines, is an early step in vascular injury, we sought to evaluate (a) changes in cellular adhesion molecule levels during the trial; (b) effect of diabetes treatment; and (c) association of markers with HbA1c, hypertension, hypercholesterolemia, nephropathy, and retinopathy.
METHODS


Participants (n = 515 of 699) that had baseline assessment of adhesion molecules (monocyte chemoattractant protein-1 [MCP-1], vascular cell adhesion marker [VCAM], intercellular adhesion marker [ICAM], and E-Selectin) and at least one other assessment, measured at month 12, 24, or 36, were included.
RESULTS


Over 1 to 3 years, significant increases in MCP-1 and decreases in VCAM (both P < .0001) concentrations were found; however, no significant interactions were identified with treatment group for any molecule. For every 1% increase in HbA1c, ICAM increased by 1.8%, VCAM by 1.5%, and E-selectin by 6.8% (all P < .0001). E-selectin increased by 3.7% and 4.2% for every 10 mm Hg increase in systolic and diastolic blood pressure, respectively (both P < .0001). ICAM was 10.2% higher and E-selectin was 15.5% higher in participants with microalbuminuria (both P < .01). There was no significant association of adhesion molecule levels with retinopathy.
CONCLUSION


Concentrations of cellular adhesion molecules rise with increasing HbA1c in youth with T2DM, and are associated with blood pressure and microalbuminuria, markers of vascular injury.",2020,ICAM was 10.2% higher and E-selectin 15.5% higher in participants with microalbuminuria (both P < 0.01).,"['type 2 diabetes (T2DM) in youth, demonstrated treatment failure (defined as sustained HbA1c ≥8%, or inability to wean insulin after 3\u2009months after acute metabolic decomposition) in over half of the participants', 'Participants (n\xa0']",[],"['E-selectin', 'adhesion molecules (MCP-1, VCAM, ICAM, and E-Selectin', 'systolic and diastolic blood pressure', 'HbA1c, ICAM', 'ICAM', 'MCP-1 and decreases in VCAM ']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",[],"[{'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",2.0,0.0525065,ICAM was 10.2% higher and E-selectin 15.5% higher in participants with microalbuminuria (both P < 0.01).,"[{'ForeName': 'Jeanie B', 'Initials': 'JB', 'LastName': 'Tryggestad', 'Affiliation': 'Department of Diabetes and Endocrinology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Rachana D', 'Initials': 'RD', 'LastName': 'Shah', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'Braffett', 'Affiliation': 'The Biostatistics Center, George Washington University, Rockville, Maryland, USA.'}, {'ForeName': 'Fida', 'Initials': 'F', 'LastName': 'Bacha', 'Affiliation': 'Department of Diabetes and Endocrinology, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Gidding', 'Affiliation': 'FH Foundation, Pasadena, California, USA.'}, {'ForeName': 'Rose A', 'Initials': 'RA', 'LastName': 'Gubitosi-Klug', 'Affiliation': 'Department of Pediatric Endocrinology, Diabetes and Metabolism, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""Division of Endocrinology, Cincinnati Children's Hospital and the University of Cincinnati, Cincinnati, Ohio, USA.""}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Urbina', 'Affiliation': ""Division of Endocrinology, Cincinnati Children's Hospital and the University of Cincinnati, Cincinnati, Ohio, USA.""}, {'ForeName': 'Lorraine E', 'Initials': 'LE', 'LastName': 'Levitt Katz', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric diabetes,['10.1111/pedi.13062']
1132,32504574,"Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials.","BACKGROUND


In the primary week-48 analyses of two phase 3 studies, coformulated bictegravir, emtricitabine, and tenofovir alafenamide was non-inferior to a dolutegravir-containing regimen in treatment-naive people with HIV. We report week-144 efficacy and safety results from these studies.
METHODS


We did two double-blind, active-controlled studies (now in open-label extension phase). Study 1 randomly assigned (1:1) HLA-B*5701-negative adults without hepatitis B virus co-infection to receive coformulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg, or coformulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine 300 mg once daily. Study 2 randomly assigned (1:1) adults to bictegravir, emtricitabine, and tenofovir alafenamide, or dolutegravir 50 mg given with coformulated emtricitabine 200 mg and tenofovir alafenamide 25 mg. We previously reported non-inferiority at the primary endpoint. Here, we report the week-144 secondary outcome of proportion of participants with plasma HIV-1 RNA less than 50 copies per mL at week 144, by US Food and Drug Administration Snapshot algorithm, analysed in the same manner. These studies were registered with ClinicalTrials.gov, NCT02607930 and NCT02607956.
FINDINGS


629 participants were randomly assigned and treated in study 1 (314 to bictegravir, emtricitabine, and tenofovir alafenamide, and 315 to dolutegravir, abacavir, and lamivudine) and 645 in study 2 (327 to bictegravir, emtricitabine, and tenofovir alafenamide, 325 to dolutegravir, emtricitabine, tenofovir alafenamide). At week 144, bictegravir, emtricitabine, and tenofovir alafenamide was non-inferior to both dolutegravir-containing regimens for efficacy. In study 1, 256 (82%) of 314 participants had plasma HIV-1 RNA less than 50 copies per mL in the bictegravir, emtricitabine, and tenofovir alafenamide group and 265 (84%) of 315 in the dolutegravir, abacavir, and lamivudine group (difference -2·6%, 95% CI -8·5 to 3·4). In study 2, 262 (82%) of 320 participants had plasma HIV-1 RNA less than 50 copies per mL in the bictegravir, emtricitabine, and tenofovir alafenamide group and 273 (84%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide group (difference -1·9%, -7·8 to 3·9). In both studies, no participant had treatment-emergent resistance to study drugs up to week 144. All treatment regimens were well tolerated with additional exposure. Adverse events that led to study drug discontinuation were reported for no participants in the bictegravir, emtricitabine, and tenofovir alafenamide group versus five (2%) of 315 in the dolutegravir, abacavir, and lamivudine group (study 1), and six (2%) of 320 in the bictegravir, emtricitabine, and tenofovir alafenamide versus six (2%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide group (study 2). In study 1, statistically significant differences were observed in median changes from baseline in fasting total cholesterol (14 mg/dL vs 10 mg/dL; p=0·034), direct LDL (21 mg/dL vs 14 mg/dL; p=0·004), and total cholesterol to HDL ratio (-0·1 vs -0·3; p=0·007) at week 144; no differences were observed between groups in study 2. Weight gain was seen across all treatment groups in both studies, with no differences in median changes from baseline in weight at week 144 for either study.
INTERPRETATION


These long-term data support the use of bictegravir, emtricitabine, and tenofovir alafenamide as a safe, well tolerated, and durable treatment for people with HIV, with no emergent resistance.
FUNDING


Gilead Sciences.",2020,"Adverse events that led to study drug discontinuation were reported for no participants in the bictegravir, emtricitabine, and tenofovir alafenamide group versus five (2%) of 315 in the dolutegravir, abacavir, and lamivudine group (study 1), and six (2%) of 320 in the bictegravir, emtricitabine, and tenofovir alafenamide versus six (2%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide group (study 2).","['people with HIV, with no emergent resistance', 'HLA-B*5701-negative adults without hepatitis B virus co-infection', '629 participants were randomly assigned and treated in study 1 (314 to']","['alafenamide', 'coformulated bictegravir, emtricitabine, and tenofovir alafenamide', 'direct LDL', 'bictegravir, emtricitabine, and tenofovir alafenamide, 325 to dolutegravir, emtricitabine, tenofovir alafenamide', 'tenofovir alafenamide', 'bictegravir, emtricitabine, and tenofovir', 'bictegravir, emtricitabine, and tenofovir alafenamide, or dolutegravir 50 mg given with coformulated emtricitabine 200 mg and tenofovir alafenamide 25 mg', 'Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens', 'bictegravir, emtricitabine, and tenofovir alafenamide', 'coformulated bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg, or coformulated dolutegravir 50 mg, abacavir 600 mg, and lamivudine', 'lamivudine', 'bictegravir, emtricitabine, and tenofovir alafenamide, and 315 to dolutegravir, abacavir, and lamivudine']","['fasting total cholesterol', 'plasma HIV-1 RNA less', 'total cholesterol to HDL ratio', 'Weight gain']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0019630', 'cui_str': 'Class II Histocompatibility Antigens'}, {'cui': 'C0440557', 'cui_str': 'B*5701'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0275524', 'cui_str': 'Mixed infectious disease'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4507568', 'cui_str': 'bictegravir'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C3663830', 'cui_str': 'dolutegravir 50 MG'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C1331249', 'cui_str': 'emtricitabine 200 MG'}, {'cui': 'C4083965', 'cui_str': 'tenofovir alafenamide 25 MG'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C4551053', 'cui_str': 'bictegravir 50 MG'}, {'cui': 'C1629814', 'cui_str': 'abacavir 600 MG'}, {'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0663655', 'cui_str': 'abacavir'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",629.0,0.25769,"Adverse events that led to study drug discontinuation were reported for no participants in the bictegravir, emtricitabine, and tenofovir alafenamide group versus five (2%) of 315 in the dolutegravir, abacavir, and lamivudine group (study 1), and six (2%) of 320 in the bictegravir, emtricitabine, and tenofovir alafenamide versus six (2%) of 325 in the dolutegravir, emtricitabine, and tenofovir alafenamide group (study 2).","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Queen Mary University of London, London, UK; Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre, London, UK.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'DeJesus', 'Affiliation': 'Orlando Immunology Center, Orlando, FL, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Arribas', 'Affiliation': 'Infectious Diseases Unit, Hospital Universitario La Paz, IdiPaz Madrid, Spain.'}, {'ForeName': 'Samir K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Division of Infectious Diseases, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Martorell', 'Affiliation': 'The Research Institute, Springfield, MA, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Stephens', 'Affiliation': 'Department of Internal Medicine, Mercer University School of Medicine, Macon, GA, USA.'}, {'ForeName': 'Hans-Jurgen', 'Initials': 'HJ', 'LastName': 'Stellbrink', 'Affiliation': 'Department of Internal Medicine, Infectious Diseases, University of Hamburg, Hamburg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wohl', 'Affiliation': 'Department of Medicine, Institute of Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Maggiolo', 'Affiliation': 'Unit of HIV-related Diseases and Experimental Therapies, Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Melanie A', 'Initials': 'MA', 'LastName': 'Thompson', 'Affiliation': 'AIDS Research Consortium of Atlanta, Atlanta, GA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Podzamczer', 'Affiliation': 'Infectious Disease Department, Hospital Universitari de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Hagins', 'Affiliation': 'Georgia Department of Public Health, Coastal Health District, Chatham Care Center, Savannah, GA, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Flamm', 'Affiliation': 'Department of Adult and Family Medicine, Kaiser Permanente Medical Group, Sacramento, CA, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Brinson', 'Affiliation': 'Central Texas Clinical Research, Austin, TX, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Clarke', 'Affiliation': 'Elton John Centre, Royal Sussex County Hospital, Brighton & Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Hailin', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Biometrics, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Acosta', 'Affiliation': 'Department of Virology, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': 'Sean E', 'Initials': 'SE', 'LastName': 'Collins', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Foster City, CA, USA. Electronic address: sean.collins@gilead.com.'}, {'ForeName': 'Hal', 'Initials': 'H', 'LastName': 'Martin', 'Affiliation': 'Department of HIV Clinical Research, Gilead Sciences, Foster City, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30099-0']
1133,32504575,"Population uptake of HIV testing, treatment, viral suppression, and male circumcision following a community-based intervention in Botswana (Ya Tsie/BCPP): a cluster-randomised trial.","BACKGROUND


In settings with high HIV prevalence and treatment coverage, such as Botswana, it is unknown whether uptake of HIV prevention and treatment interventions can be increased further. We sought to determine whether a community-based intervention to identify and rapidly treat people living with HIV, and support male circumcision could increase population levels of HIV diagnosis, treatment, viral suppression, and male circumcision in Botswana.
METHODS


The Ya Tsie Botswana Combination Prevention Project study was a pair-matched cluster-randomised trial done in 30 communities across Botswana done from Oct 30, 2013, to June 30, 2018. 15 communities were randomly assigned to receive HIV prevention and treatment interventions, including enhanced HIV testing, earlier antiretroviral therapy (ART), and strengthened male circumcision services, and 15 received standard of care. The first primary endpoint of HIV incidence has already been reported. In this Article, we report findings for the second primary endpoint of population uptake of HIV prevention services, as measured by proportion of people known to be HIV-positive or tested HIV-negative in the preceding 12 months; proportion of people living with HIV diagnosed and on ART; proportion of people living with HIV on ART with viral suppression; and proportion of HIV-negative men circumcised. A longitudinal cohort of residents aged 16-64 years from a random, approximately 20% sample of households across the 15 communities was enrolled to assess baseline uptake of study outcomes; we also administered an end-of-study survey to all residents not previously enrolled in the longitudinal cohort to provide study end coverage estimates. Differences in intervention uptake over time by randomisation group were tested via paired Student's t test. The study has been completed and is registered with ClinicalTrials.gov (NCT01965470).
FINDINGS


In the six communities participating in the end-of-study survey, 2625 residents (n=1304 from standard-of-care communities, n=1321 from intervention communities) were enrolled into the 20% longitudinal cohort at baseline from Oct 30, 2013, to Nov 24, 2015. In the same communities, 10 791 (86%) of 12 489 eligible enumerated residents not previously enrolled in the longitudinal cohort participated in the end-of-study survey from March 30, 2017, to Feb 25, 2018 (5896 in intervention and 4895 in standard-of-care communities). At study end, in intervention communities, 1228 people living with HIV (91% of 1353) were on ART; 1166 people living with HIV (88% of 1321 with available viral load) were virally suppressed, and 673 HIV-negative men (40% of 1673) were circumcised in intervention communities. After accounting for baseline differences, at study end the proportion of people living with HIV who were diagnosed was significantly higher in intervention communities (absolute increase of 9% to 93%) compared with standard-of-care communities (absolute increase of 2% to 88%; prevalence ratio [PR] 1·08 [95% CI 1·02-1·14], p=0·032). Population levels of ART, viral suppression, and male circumcision increased from baseline in both groups, with greater increases in intervention communities (ART PR 1·12 [95% CI 1·07-1·17], p=0·018; viral suppression 1·13 [1·09-1·17], p=0·017; male circumcision 1·26 [1·17-1·35], p=0·029).
INTERPRETATION


It is possible to achieve very high population levels of HIV testing and treatment in a high-prevalence setting. Maintaining these coverage levels over the next decade could substantially reduce HIV transmission and potentially eliminate the epidemic in these areas.
FUNDING


US President's Emergency Plan for AIDS Relief through the Centers for Disease Control and Prevention.",2020,"Population levels of ART, viral suppression, and male circumcision increased from baseline in both groups, with greater increases in intervention communities (ART PR 1·12 [95% CI 1·07-1·17], p=0·018; viral suppression 1·13 [1·09-1·17], p=0·017; male circumcision 1·26 [1·17-1·35], p=0·029).
","['In the same communities, 10\u2008791 (86%) of 12\u2008489 eligible enumerated residents not previously enrolled in the longitudinal cohort participated in the end-of-study survey from March 30, 2017, to Feb 25, 2018 (5896 in intervention and 4895 in standard-of-care communities', 'residents aged 16-64 years from a random, approximately 20% sample of households across the 15 communities was enrolled to assess baseline uptake of study outcomes; we also administered an end-of-study survey to all residents not previously enrolled in the longitudinal cohort to provide study end coverage estimates', '15 communities', 'people living with HIV diagnosed and on ART; proportion of people living with HIV on ART with viral suppression; and proportion of HIV-negative men circumcised', '30 communities across Botswana done from Oct 30, 2013, to June 30, 2018', 'six communities participating in the end-of-study survey, 2625 residents (n=1304 from standard-of-care communities, n=1321 from intervention communities) were enrolled into the 20% longitudinal cohort at baseline from Oct 30, 2013, to Nov 24, 2015', '1228 people living with HIV (91% of 1353) were on ART; 1166 people living with HIV (88% of 1321 with available viral load) were virally suppressed, and 673 HIV-negative men (40% of 1673) were circumcised in intervention communities']","['community-based intervention in Botswana (Ya Tsie/BCPP', 'HIV prevention and treatment interventions, including enhanced HIV testing, earlier antiretroviral therapy (ART), and strengthened male circumcision services, and 15 received standard of care']","['Population levels of ART, viral suppression, and male circumcision']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0920194', 'cui_str': 'Circumcised'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}]",15.0,0.247072,"Population levels of ART, viral suppression, and male circumcision increased from baseline in both groups, with greater increases in intervention communities (ART PR 1·12 [95% CI 1·07-1·17], p=0·018; viral suppression 1·13 [1·09-1·17], p=0·017; male circumcision 1·26 [1·17-1·35], p=0·029).
","[{'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Wirth', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA. Electronic address: kathleen.wirth@gmail.com.'}, {'ForeName': 'Tendani', 'Initials': 'T', 'LastName': 'Gaolathe', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Pretorius Holme', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Mompati', 'Initials': 'M', 'LastName': 'Mmalane', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Kadima', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Unoda', 'Initials': 'U', 'LastName': 'Chakalisa', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Kutlo', 'Initials': 'K', 'LastName': 'Manyake', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Atang', 'Initials': 'A', 'LastName': 'Matildah Mbikiwa', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Selebaleng V', 'Initials': 'SV', 'LastName': 'Simon', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Letlhogile', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Kutlwano', 'Initials': 'K', 'LastName': 'Mukokomani', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Widenfelt', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Sikhulile', 'Initials': 'S', 'LastName': 'Moyo', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Bennett', 'Affiliation': 'Bennett Statistical Consulting, Ballston Lake, NY, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Leidner', 'Affiliation': 'Goodtables Data Consulting, Norman, Oklahoma, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Powis', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Department of Medicine, Massachusetts General Hospital, Boston, MA, USA; Department of Pediatrics, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Refeletswe', 'Initials': 'R', 'LastName': 'Lebelonyane', 'Affiliation': 'Ministry of Health and Wellness, Botswana, Gaborone, Botswana.'}, {'ForeName': 'Mary Grace', 'Initials': 'MG', 'LastName': 'Alwano', 'Affiliation': 'Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Jarvis', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Scott L', 'Initials': 'SL', 'LastName': 'Dryden-Peterson', 'Affiliation': ""Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Coulson', 'Initials': 'C', 'LastName': 'Kgathi', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Bachanas', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Raizes', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Abrams', 'Affiliation': 'Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Block', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA; Intellectual Concepts, Atlanta, GA, USA.'}, {'ForeName': 'Baraedi', 'Initials': 'B', 'LastName': 'Sento', 'Affiliation': 'Tebelopele Voluntary Counseling and Testing Center, Gaborone, Botswana.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Novitsky', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Shenaaz', 'Initials': 'S', 'LastName': 'El-Halabi', 'Affiliation': 'Ministry of Health and Wellness, Botswana, Gaborone, Botswana.'}, {'ForeName': 'Tafireyi', 'Initials': 'T', 'LastName': 'Marukutira', 'Affiliation': 'Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Mills', 'Affiliation': 'Centers for Disease Control and Prevention-Botswana, Gaborone, Botswana.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Sexton', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Sherri', 'Initials': 'S', 'LastName': 'Pals', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Roger L', 'Initials': 'RL', 'LastName': 'Shapiro', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA; Harvard Pilgrim Health Care Institute, Boston, MA, USA.'}, {'ForeName': 'Quanhong', 'Initials': 'Q', 'LastName': 'Lei', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'DeGruttola', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Makhema', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Myron', 'Initials': 'M', 'LastName': 'Essex', 'Affiliation': 'Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Lockman', 'Affiliation': ""Department of Immunology and Infectious Diseases, Harvard T H Chan School of Public Health, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Division of Infectious Diseases, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Tchetgen Tchetgen', 'Affiliation': 'Department of Biostatistics, Harvard T H Chan School of Public Health, Boston, MA, USA; Department of Statistics, The Wharton School at the University of Pennsylvania, Philadelphia, PA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30103-X']
1134,32507285,[Comparison of two supraglottic airway devices on postoperative sore throat in children: a prospective randomized controlled trial].,"BACKGROUND AND OBJECTIVE


Sore throat is well recognized complaint after receiving general anesthesia. This study is conducted to compare the severity and frequency of postoperative sore throat in children undergoing elective surgery - following the use of Ambu laryngeal mask airway) or I-gel® - who are able to self-report postoperative sore throat.
METHOD


Seventy children, 6 to 16 years-old, undergoing elective surgery randomly allocated to either Ambu laryngeal mask (Ambu Group) or I-gel® (I-gel Group). After the procedure, patients were interviewed in the recovery room immediately, after one hour, 6 and 24 hours postoperatively by an independent observer blinded to the device used intra-operatively.
RESULTS


On arrival in the recovery room 17.1% (n=6) of children of the Ambu Group complained of postoperative sore throat, against 5.7% in I-gel Group (n=2). After one hour, the results were similar. After 6 hours, postoperative sore throat was found in 8.6% (n=3) of the children in Ambu group vs. 2.9% (n=1) in I-gel Group. After 24hours, 2.9% (n=1) of the kids in Ambu Group compared to none in I-gel Group. There was no significant difference found in the incidence of postoperative sore throat in both devices on arrival (p=0.28); after 1 hour (p=0.28); after 6 hours (p=0.30); and after 24 hours (p=0.31). The duration of the insertion was shorter in Ambu Group and it was easier to insert the I-gel® (p=0.029). Oropharyngeal seal pressure of I-gel® was higher than that of Ambu laryngeal mask (p=0.001).
CONCLUSION


The severity and frequency of postoperative sore throat in children is not statistically significant in the I-gel Group compared to Ambu Group.",2020,The duration of the insertion was shorter in Ambu Group,"['children undergoing elective surgery - following the use of Ambu laryngeal mask airway) or I-gel® - who are able to self-report postoperative sore throat', 'Seventy children, 6 to 16 years-old, undergoing elective surgery randomly allocated to either', 'children']","['Ambu laryngeal mask (Ambu Group) or I-gel® (I-gel Group', 'supraglottic airway devices']","['severity and frequency of postoperative sore throat', 'incidence of postoperative sore throat', 'duration of the insertion', 'Oropharyngeal seal pressure of I-gel®', 'postoperative sore throat']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C4076036', 'cui_str': 'Supraglottic airway'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031350', 'cui_str': 'Pharyngitis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]",70.0,0.0754609,The duration of the insertion was shorter in Ambu Group,"[{'ForeName': 'Malika', 'Initials': 'M', 'LastName': 'Hameed', 'Affiliation': 'Aga Khan University Hospital, Department of Anesthesiology, Karachi, Pakistan. Electronic address: malika.hameed@gmail.com.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Samad', 'Affiliation': 'Aga Khan University Hospital, Department of Anesthesiology, Karachi, Pakistan.'}, {'ForeName': 'Hameed', 'Initials': 'H', 'LastName': 'Ullah', 'Affiliation': 'Aga Khan University Hospital, Department of Anesthesiology, Karachi, Pakistan.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.03.006']
1135,32512364,Intake of Camelina Sativa Oil and Fatty Fish Alter the Plasma Lipid Mediator Profile in Subjects with Impaired Glucose Metabolism - A Randomized Controlled Trial.,"n-3 and n-6 polyunsaturated fatty acids (PUFAs) and their lipid mediator metabolites are associated with inflammation. We investigated the effect of dietary intake of plant- and animal-derived n-3 PUFAs and fish protein on the circulatory concentrations of lipid mediators. Seventy-nine subjects with impaired fasting glucose who completed the controlled dietary intervention after randomization to the fatty fish (FF, n=20), lean fish (LF, n=21), Camelina sativa oil (CSO, n=18) or control group (n=20) for 12 weeks were studied. Lipid mediator profiling from fasting plasma samples before and after the intervention was performed by liquid chromatography-mass spectrometry (LC-MS/MS). The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and 4- and 17-hydroxydocosahexaenoic acid (4-, 17-HDoHE) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), respectively. Concentrations of lipid mediators derived from α-linolenic acid (ALA) increased and arachidonic acid (AA) derived 5-iso prostaglandin F 2α -VI decreased in the CSO group. There were no significant changes in lipid mediators in the LF group. The dietary intake of both plant and animal-based n-3 PUFAs increased circulatory concentrations of lipid mediators with potential anti-inflammatory properties.",2020,The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and,"['Subjects with Impaired Glucose Metabolism ', 'Seventy-nine subjects with impaired fasting glucose who completed the controlled dietary intervention after randomization to the fatty fish (FF, n=20), lean fish (LF, n=21']","['plant- and animal-derived n-3 PUFAs and fish protein', 'Camelina sativa oil (CSO, n=18) or control group', 'Camelina Sativa Oil and Fatty Fish', 'n-3 and n-6 polyunsaturated fatty acids (PUFAs', 'plant and animal-based n-3 PUFAs', '4- and 17-hydroxydocosahexaenoic acid (4-, 17-HDoHE) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA']","['lipid mediators', 'arachidonic acid (AA) derived 5-iso prostaglandin F 2α -VI', 'concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE', 'Plasma Lipid Mediator Profile']","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]","[{'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0598294', 'cui_str': 'Fish Proteins'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0639949', 'cui_str': '17-hydroxy-4,7,10,13,15,19-docosahexaenoic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0033561', 'cui_str': 'F series prostaglandin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3251952', 'cui_str': '18(R)-hydroxyeicosapentaenoic acid'}, {'cui': 'C0019215', 'cui_str': ""N-2-Hydroxyethylpiperazine-N'-2'-ethanesulfonic Acid""}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}]",79.0,0.053379,The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and,"[{'ForeName': 'Topi', 'Initials': 'T', 'LastName': 'Meuronen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland. Electronic address: topim@uef.fi.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Lankinen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fauland', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bun-Ichi', 'Initials': 'BI', 'LastName': 'Shimizu', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Vanessa D', 'Initials': 'VD', 'LastName': 'de Mello', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Laaksonen', 'Affiliation': 'Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, 70029 Kuopio University Hospital, Finland; Institute of Biomedicine, Physiology, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Wheelock', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Arja T', 'Initials': 'AT', 'LastName': 'Erkkilä', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Ursula S', 'Initials': 'US', 'LastName': 'Schwab', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland; Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, 70029 Kuopio University Hospital, Finland.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102143']
1136,31554489,Validation of an Emotion Regulation Training Program on Mental Well-Being.,"This research aimed to validate an Emotion Regulation Training program cultivating resilience, strengthening interpersonal communication, and enhancing emotional intelligence. A community sample of 104 participants were assigned to either an intervention ( n  =   51) or nonactive control ( n  =   53) group matched by age and gender. In addition, data were gathered via a cognitive performance test conducted pre- and postmeasurement in a subset of the larger sample ( n  =   19 intervention,  n  =   19 control). Results revealed reappraisal significantly increased in the intervention group, which was associated with a decrease in depressive symptomology, worry, and suppression, and a concurrent increase in overall mental well-being, supporting the validation of the Emotion Regulation Training program.",2020,"Results revealed reappraisal significantly increased in the intervention group, which was associated with a decrease in depressive symptomology, worry, and suppression, and a concurrent increase in overall mental well-being, supporting the validation of the Emotion Regulation Training program.",['A community sample of 104 participants'],"['Emotion Regulation Training Program', 'nonactive control']","['depressive symptomology, worry, and suppression']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",104.0,0.0281302,"Results revealed reappraisal significantly increased in the intervention group, which was associated with a decrease in depressive symptomology, worry, and suppression, and a concurrent increase in overall mental well-being, supporting the validation of the Emotion Regulation Training program.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'LeBlanc', 'Affiliation': 'Department of Psychology, University of Roehampton, London, UK.'}, {'ForeName': 'Bilge', 'Initials': 'B', 'LastName': 'Uzun', 'Affiliation': 'Department of Guidance and Counseling, Bahcesehir University, Istanbul, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Aydemir', 'Affiliation': 'Faculty of Educational Sciences, Bahcesehir University, Istanbul, Turkey.'}, {'ForeName': 'Changiz', 'Initials': 'C', 'LastName': 'Mohiyeddini', 'Affiliation': 'Department of Applied Psychology, Northeastern University, Boston, MA, USA.'}]",Psychological reports,['10.1177/0033294119878399']
1137,31564217,"Effects of a Self-Compassion Break Induction on Self-Reported Stress, Self-Compassion, and Depressed Mood.","INTRODUCTION


The objective of the study was to determine whether practicing a self-compassion induction would reduce self-reported stress, depressed mood, and increase self-compassion in a randomized controlled study measuring variables of interest at two time points spanning three weeks.
METHOD


Participants were 129 students (91 females and 38 males,  M age  = 19.47,  SD  = 3.20) divided into three groups: Self-compassion Break, Time Management Control Group, and a No-Induction Control Group. Participants were part of the general student body and were not diagnosed or screened for clinical depression. Self-compassion, stress, and depressed mood were assessed at baseline and follow-up. Participants practiced their respective inductions over three weeks after being guided through their respective inductions at Time 1.
RESULTS


There were no significant differences between groups in outcome variables. Results of this study may indicate the importance of weekly group check-in meetings to facilitate positive change as findings in this study did not mirror those of similar studies using frequent meetings.",2020,There were no significant differences between groups in outcome variables.,"['Participants were 129 students (91 females and 38 males,  M age \u2009=\u200919.47,  SD \u2009=\u20093.20) divided into three groups', 'Participants were part of the general student body and were not diagnosed or screened for clinical depression']","['Self-compassion Break, Time Management Control Group, and a No-Induction Control Group', 'Self-Compassion Break Induction']","['Self-Reported Stress, Self-Compassion, and Depressed Mood', 'Self-compassion, stress, and depressed mood']","[{'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0206209', 'cui_str': 'Time Management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}]",129.0,0.0197939,There were no significant differences between groups in outcome variables.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': 'Department of Psychology, California State University, Bakersfield, Bakersfield, CA, USA.'}]",Psychological reports,['10.1177/0033294119877817']
1138,32525955,Simulation-based training using a vessel phantom effectively improved first attempt success and dynamic needle-tip positioning ability for ultrasound-guided radial artery cannulation in real patients: An assessor-blinded randomized controlled study.,"BACKGROUND


We evaluated whether a simulation-based training with a vessel phantom improves the basic skills of a novice required for ultrasound-guided radial artery cannulation in real patients. In addition, we analysed whether repeated simulation training sets with an inter-training interval would accelerate the learning curve.
METHODS


From March 2019 to July 2019, twenty-one anesthesiology residents were randomized into either a simulation group (n = 11) or control group (n = 10). Residents performed a total of 84 ultrasound-guided radial artery cannulations in real patients. The simulation group participated in two sets of simulation training on a vessel phantom (10 sessions per set) with a one-month inter-training interval. Trainee's performance proficiency was scored using a developed checklist, and a learning curve for each training set was constructed. To evaluate the effectiveness of our training curriculum in skill transfer, each resident performed four ultrasound-guided radial artery cannulations in real patients. The primary outcome was first attempt success rate and the secondary outcome was dynamic needle-tip positioning ability in real patients.
RESULTS


The first attempt success rate and dynamic needle-tip positioning ability by ultrasound transducer were significantly higher in the simulation group than the control group (81.8% vs. 50%, P = 0.002 and 68.2% vs. 7.5%, P < 0.001, respectively). A reduced number of sessions was required to reach a plateau score on the learning curve in the repeated training set compared in the first-set (7 (5-8) vs. 3 (2-4), P = 0.003, respectively).
CONCLUSIONS


Simulation-based training using a vessel phantom effectively improved the first attempt success rate for ultrasound-guided radial artery cannulation in real patients and the dynamic needle-tip positioning ability by ultrasound transducer in novice anesthesiology residents. In addition, repeated training curriculum accelerated the learning curve for recall skill proficiency and reduced inter-individual variability for skill acquisition.
CLINICAL TRIAL REGISTRATION


Clinical Research Information Service (KCT0003471, Principle investigator: Jeong Jin Min, Date of registration: 06/March/2019).",2020,"The first attempt success rate and dynamic needle-tip positioning ability by ultrasound transducer were significantly higher in the simulation group than the control group (81.8% vs. 50%, P = 0.002 and 68.2% vs. 7.5%, P < 0.001, respectively).","['From March 2019 to July 2019, twenty-one anesthesiology residents', 'real patients']","['simulation training on a vessel phantom (10 sessions per set) with a one-month inter-training interval', '84 ultrasound-guided radial artery cannulations', 'ultrasound-guided radial artery cannulation']","['success rate and the secondary outcome was dynamic needle-tip positioning ability in real patients', 'success rate and dynamic needle-tip positioning ability by ultrasound transducer']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0282611', 'cui_str': 'Phantom'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0040661', 'cui_str': 'Transducer'}]",,0.0489383,"The first attempt success rate and dynamic needle-tip positioning ability by ultrasound transducer were significantly higher in the simulation group than the control group (81.8% vs. 50%, P = 0.002 and 68.2% vs. 7.5%, P < 0.001, respectively).","[{'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Oh', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jong-Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Eun Jin', 'Initials': 'EJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeong Jin', 'Initials': 'JJ', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University, School of Medicine, Seoul, Korea.'}]",PloS one,['10.1371/journal.pone.0234567']
1139,32497023,l-Arginine supplementation in severe asthma.,"BACKGROUNDDysregulation of l-arginine metabolism has been proposed to occur in patients with severe asthma. The effects of l-arginine supplementation on l-arginine metabolite profiles in these patients are unknown. We hypothesized that individuals with severe asthma with low fractional exhaled nitric oxide (FeNO) would have fewer exacerbations with the addition of l-arginine to their standard asthma medications compared with placebo and would demonstrate the greatest changes in metabolite profiles.METHODSParticipants were enrolled in a single-center, crossover, double-blind l-arginine intervention trial at UCD. Subjects received placebo or l-arginine, dosed orally at 0.05 mg/kg (ideal body weight) twice daily. The primary end point was moderate asthma exacerbations. Longitudinal plasma metabolite levels were measured using mass spectrometry. A linear mixed-effect model with subject-specific intercepts was used for testing treatment effects.RESULTSA cohort of 50 subjects was included in the final analysis. l-Arginine did not significantly decrease asthma exacerbations in the overall cohort. Higher citrulline levels and a lower arginine availability index (AAI) were associated with higher FeNO (P = 0.005 and P = 2.51 × 10-9, respectively). Higher AAI was associated with lower exacerbation events. The eicosanoid prostaglandin H2 (PGH2) and Nα-acetyl-l-arginine were found to be good predictors for differentiating clinical responders and nonresponders.CONCLUSIONSThere was no statistically significant decrease in asthma exacerbations in the overall cohort with l-arginine intervention. PGH2, Nα-acetyl-l-arginine, and the AAI could serve as predictive biomarkers in future clinical trials that intervene in the arginine metabolome.TRIAL REGISTRATIONClinicalTrials.gov NCT01841281.FUNDINGThis study was supported by NIH grants R01HL105573, DK097154, UL1 TR001861, and K08HL114882. Metabolomics analysis was supported in part by a grant from the University of California Tobacco-Related Disease Research Program program (TRDRP).",2020,Higher citrulline levels and a lower arginine availability index (AAI) were associated with higher FeNO (P-value = 0.005 and 2.51 x 10-9 respectively).,"['severe asthma patients', 'Participants were enrolled in a single-center, cross-over, double-blinded, L-arginine intervention trial at the University of California-Davis (NCT01841281', 'severe asthma', '50 subjects was included in the final analysis']","['L-arginine supplementation', 'placebo or L-arginine', 'placebo']","['asthma exacerbations', 'Longitudinal plasma metabolite levels', 'Higher citrulline levels and a lower arginine availability index (AAI', 'moderate asthma exacerbations', 'L-arginine metabolite profiles', 'eicosanoid prostaglandin H2 (PGH2) and Nα-Acetyl-L-arginine']","[{'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0581125', 'cui_str': 'Moderate asthma'}, {'cui': 'C0013725', 'cui_str': 'Eicosanoid'}, {'cui': 'C0072288', 'cui_str': 'Prostaglandin PGH2'}]",50.0,0.280177,Higher citrulline levels and a lower arginine availability index (AAI) were associated with higher FeNO (P-value = 0.005 and 2.51 x 10-9 respectively).,"[{'ForeName': 'Shu-Yi', 'Initials': 'SY', 'LastName': 'Liao', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, UCD, Sacramento, California, USA.'}, {'ForeName': 'Megan R', 'Initials': 'MR', 'LastName': 'Showalter', 'Affiliation': 'NIH West Coast Metabolomics Center.'}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Linderholm', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, UCD, Sacramento, California, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Franzi', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, UCD, Sacramento, California, USA.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Kivler', 'Affiliation': 'Department of Respiratory Therapy, and.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Public Health Sciences, UCD, Davis, California, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Sa', 'Affiliation': 'NIH West Coast Metabolomics Center.'}, {'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Kons', 'Affiliation': 'NIH West Coast Metabolomics Center.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Fiehn', 'Affiliation': 'NIH West Coast Metabolomics Center.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Public Health Sciences, UCD, Davis, California, USA.'}, {'ForeName': 'Amir A', 'Initials': 'AA', 'LastName': 'Zeki', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, UCD, Sacramento, California, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Kenyon', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, UCD, Sacramento, California, USA.'}]",JCI insight,['10.1172/jci.insight.137777']
1140,32506309,"Evaluation of Fixed-Dose Combinations of Ibuprofen and Acetaminophen in the Treatment of Postsurgical Dental Pain: A Pilot, Dose-Ranging, Randomized Study.","INTRODUCTION


Ibuprofen and acetaminophen provide analgesia via different mechanisms of action and do not exhibit drug-drug interactions; therefore, combining low doses of each may provide greater efficacy without compromising safety.
OBJECTIVES


The present study assessed the analgesic efficacy of fixed-dose combinations (FDCs) of ibuprofen/acetaminophen (IBU/APAP) compared with ibuprofen 400 mg and placebo.
METHODS


This 12-h, double-blind, proof-of-concept study compared three FDCs of IBU/APAP (200 mg/500 mg, 250 mg/500 mg, and 300 mg/500 mg) with ibuprofen 400 mg and placebo in patients with moderate-to-severe pain following third molar extraction. The primary endpoint was the time-weighted sum of pain relief and pain intensity difference scores from 0 to 8 h after dosing (SPRID[4] 0-8 ). Time to meaningful pain relief (TMPR), duration of pain relief, and adverse events (AEs) were also assessed.
RESULTS


In total, 394 patients were randomized. All active treatments were superior to placebo for SPRID[4] 0-8  (all p < 0.001) but not significantly different from ibuprofen 400 mg. Median TMPR with FDCs and ibuprofen (44.5-54.1 and 56.2 min, respectively) was faster than with placebo (> 720 min; all p < 0.001 vs. placebo). Duration of pain relief was similar with the FDCs and ibuprofen 400 mg (9.7 -11.1 h) and longer than with placebo (1.6 h; all p < 0.001). AE incidence was comparable with all treatments.
CONCLUSION


Each IBU/APAP FDC provided analgesic efficacy comparable to that with ibuprofen 400 mg and superior to that with placebo. Each FDC provided MPR in < 1 h, duration of pain relief > 9 h, and tolerability similar to that with ibuprofen and placebo. CLINICALTRIALS.
GOV REGISTRATION


NCT01559259.",2020,All active treatments were superior to placebo for SPRID[4] 0-8  (all p < 0.001) but not significantly different from ibuprofen 400 mg.,"['patients with moderate-to-severe pain following third molar extraction', '394 patients were randomized']","['ibuprofen 400\xa0mg and placebo', 'ibuprofen/acetaminophen (IBU/APAP', 'placebo', 'FDCs and ibuprofen', 'Ibuprofen and Acetaminophen', 'APAP', 'ibuprofen', 'Ibuprofen and acetaminophen']","['Median TMPR with FDCs and ibuprofen', 'time-weighted sum of pain relief and pain intensity difference scores', 'Time to meaningful pain relief (TMPR), duration of pain relief, and adverse events (AEs', 'Duration of pain relief', 'duration of pain relief', 'analgesic efficacy', 'AE incidence', 'Postsurgical Dental Pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0992428', 'cui_str': 'Ibuprofen 400 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0721022', 'cui_str': 'Ibu'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}]",394.0,0.565432,All active treatments were superior to placebo for SPRID[4] 0-8  (all p < 0.001) but not significantly different from ibuprofen 400 mg.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kellstein', 'Affiliation': 'Pfizer Consumer Healthcare, Madison, NJ, USA. david.kellstein@gmail.com.'}, {'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Leyva', 'Affiliation': 'Pfizer Consumer Healthcare, Madison, NJ, USA.'}]",Drugs in R&D,['10.1007/s40268-020-00310-7']
1141,32505213,"A randomized, open-label, Phase III study of obinutuzumab or rituximab plus CHOP in patients with previously untreated diffuse large B-Cell lymphoma: final analysis of GOYA.","BACKGROUND


Rituximab (R) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) is the current standard therapy for diffuse large B cell lymphoma (DLBCL). Obinutuzumab (G), a glycoengineered, type II anti-CD20 monoclonal antibody, has shown activity and an acceptable safety profile when combined with CHOP (G-CHOP) in patients with advanced DLBCL. We present the final analysis results of the Phase III GOYA study (NCT01287741), which compared the efficacy and safety of G-CHOP versus R-CHOP in patients with previously untreated DLBCL.
METHODS


Patients aged ≥ 18 years with previously untreated advanced DLBCL were randomly assigned to receive eight 21-day cycles of R or G, plus six or eight cycles of CHOP. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival, other time-to-event endpoints, and safety; investigator-assessed PFS by cell of origin subgroup was an exploratory endpoint.
RESULTS


A total of 1418 patients were randomized, with 1414 included in this final analysis (G-CHOP, N = 704; R-CHOP, N = 710). Five-year PFS rates were 63.8% and 62.6% for G-CHOP and R-CHOP, respectively (stratified hazard ratio 0.94, 95% CI 0.78-1.12; p = 0.48). The results of the secondary efficacy endpoints did not show a benefit of G-CHOP over R-CHOP. In the exploratory analysis, a trend towards benefit with G-CHOP over R-CHOP was apparent in the patients with germinal center B cell DLBCL. The safety profile of G-CHOP was as expected, and no new safety signals were observed. More grade 3-5 (75.1% vs 65.8%), serious (44.4% vs 38.4%), and fatal (6.1% vs 4.4%) adverse events (AEs) were observed in the G-CHOP arm compared with the R-CHOP arm, respectively, with the most common fatal AEs being infections. A higher incidence of late-onset neutropenia occurred in the G-CHOP arm (8.7%) versus the R-CHOP arm (4.9%).
CONCLUSIONS


The final analysis, similar to the primary analysis, did not show a PFS benefit of G-CHOP over R-CHOP in previously untreated patients with DLBCL. The results of the secondary endpoints were consistent with the primary endpoint. Further exploratory analyses and investigation of biomarkers are ongoing.",2020,"Five-year PFS rates were 63.8% and 62.6% for G-CHOP and R-CHOP, respectively (stratified hazard ratio 0.94, 95% CI 0.78-1.12; p = 0.48).","['patients with advanced DLBCL', 'patients with germinal center B cell DLBCL', 'patients with previously untreated DLBCL', 'A total of 1418 patients were randomized, with 1414 included in this final analysis (G-CHOP, N = 704; R-CHOP, N = 710', 'diffuse large B cell lymphoma (DLBCL', 'patients with previously untreated diffuse large B-Cell lymphoma', 'Patients aged ≥ 18\u2009years with previously untreated advanced DLBCL']","['obinutuzumab or rituximab plus CHOP', 'Rituximab (R) plus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP', 'R or G, plus six or eight cycles of CHOP', 'G-CHOP', 'G-CHOP versus R-CHOP', 'CHOP (G-CHOP', 'Obinutuzumab (G']","['investigator-assessed progression-free survival (PFS', 'overall survival, other time-to-event endpoints, and safety; investigator-assessed PFS', 'benefit of G-CHOP over R-CHOP', 'PFS benefit of G-CHOP', 'efficacy and safety', 'late-onset neutropenia', 'PFS rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C0282491', 'cui_str': 'Structure of germinal center of lymph node'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3805247', 'cui_str': 'Late onset neutropenia'}]",1418.0,0.285844,"Five-year PFS rates were 63.8% and 62.6% for G-CHOP and R-CHOP, respectively (stratified hazard ratio 0.94, 95% CI 0.78-1.12; p = 0.48).","[{'ForeName': 'Laurie H', 'Initials': 'LH', 'LastName': 'Sehn', 'Affiliation': 'BC Cancer Centre for Lymphoid Cancer and the University of British Columbia, Vancouver, BC, Canada. Lsehn@bccancer.bc.ca.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Martelli', 'Affiliation': 'Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Trněný', 'Affiliation': 'Charles University General Hospital, Prague, Czech Republic.'}, {'ForeName': 'Wenxin', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Roche Pharma Development, Shanghai, China.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Bolen', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Knapp', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Sahin', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Gila', 'Initials': 'G', 'LastName': 'Sellam', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Vitolo', 'Affiliation': 'Candiolo Cancer Institute, FPO-IRCCS, (Turin), Candiolo, Italy.'}]",Journal of hematology & oncology,['10.1186/s13045-020-00900-7']
1142,32512124,Placebo-induced pain reduction is associated with negative coupling between brain networks at rest.,"Placebos can reduce pain by inducing beliefs in the effectiveness of an actually inert treatment. Such top-down effects on pain typically engage lateral and medial prefrontal regions, the insula, somatosensory cortex, as well as the thalamus and brainstem during pain anticipation or perception. Considering the level of large-scale brain networks, these regions spatially align with fronto-parietal/executive control, salience, and sensory-motor networks, but it is unclear if and how placebos alter interactions between them during rest. Here, we investigated how placebo analgesia affected intrinsic network coupling. Ninety-nine human participants were randomly assigned to a placebo or control group and underwent resting-state fMRI after pain processing. Results revealed inverse coupling between two resting-state networks in placebo but not control participants. Specifically, networks comprised the bilateral somatosensory cortex and posterior insula, as well as the brainstem, thalamus, striatal regions, dorsal and rostral anterior cingulate cortex, and the anterior insula, respectively. Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group. Altogether, these findings provide initial evidence that placebo analgesia affects the intrinsic communication between large-scale brain networks, even in the absence of pain. We suggest a theoretical model where placebo analgesia might affect processing within a descending pain-modulatory network, potentially segregating it from somatosensory regions that may code for painful experiences.",2020,"Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group.",['Ninety-nine human participants'],"['Placebos', 'Placebo', 'placebo or control group and underwent resting-state fMRI after pain processing', 'placebo']","['individual pain intensity', 'pain reduction', 'medication effectiveness', 'pain']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0423732', 'cui_str': 'After pains'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",99.0,0.206348,"Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group.","[{'ForeName': 'Isabella C', 'Initials': 'IC', 'LastName': 'Wagner', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria. Electronic address: isabella.wagner@univie.ac.at.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rütgen', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hummer', 'Affiliation': 'MR Centre of Excellence, Centre for Medical Physics and Biomedical Engineering, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Windischberger', 'Affiliation': 'MR Centre of Excellence, Centre for Medical Physics and Biomedical Engineering, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117024']
1143,32512127,"Creating while taking turns, the choice to unlocking group creative potential.","This study aimed to examine how communication modes affect creative idea generation in groups. Three communication mode conditions were created: natural (N), turn-taking (T), and electronic brainstorming (E). Participants were randomly recruited and grouped in dyads to solve one alternative uses task (AUT) in each condition, during which functional near-infrared spectroscopy (fNIRS)-based hyperscanning was used to record interpersonal neural responses. No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition. In addition, AUT uniqueness, AUT fluency, and perspective-taking behaviours increased faster in the T condition than in the other conditions. The T condition also showed higher perspective-taking behaviours than did the other conditions. Moreover, fNIRS data showed higher interpersonal brain synchronisation (IBS) increments at the right angular gyrus in the T condition than in the other conditions, which positively predicted perspective-taking behaviours between individuals during group creativity tasks. These findings indicate that when group members create together while taking turns, both creative performance and interpersonal interaction processes can be stimulated.",2020,"No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition.",[],[],"['AUT fluency, and perspective-taking behaviours', 'perspective-taking behaviours', 'interpersonal brain synchronisation (IBS', 'AUT fluency']",[],[],"[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",,0.0212556,"No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition.","[{'ForeName': 'Kelong', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Hao', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China. Electronic address: nhao@psy.ecnu.edu.cn.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117025']
1144,32510976,Single-Session Bronchial Thermoplasty Guided by  129 Xe Magnetic Resonance Imaging. A Pilot Randomized Controlled Clinical Trial.,"Rationale:  Adverse events have limited the use of bronchial thermoplasty (BT) in severe asthma. Objectives:  We sought to evaluate the effectiveness and safety of using  129 Xe magnetic resonance imaging ( 129 Xe MRI) to prioritize the most involved airways for guided BT. Methods:  Thirty subjects with severe asthma were imaged with volumetric computed tomography and  129 Xe MRI to quantitate segmental ventilation defects. Subjects were randomized to treatment of the six most involved airways in the first session (guided group) or a standard three-session BT (unguided). The primary outcome was the change in Asthma Quality of Life Questionnaire score from baseline to 12 weeks after the first BT for the guided group compared with after three treatments for the unguided group. Measurements and Main Results:  There was no significant difference in quality of life after one guided compared with three unguided BTs (change in Asthma Quality of Life Questionnaire guided = 0.91 [95% confidence interval, 0.28-1.53]; unguided = 1.49 [95% confidence interval, 0.84-2.14];  P  = 0.201). After one BT, the guided group had a greater reduction in the percentage of poorly and nonventilated lung from baseline when compared with unguided (-17.2%;  P  = 0.009). Thirty-three percent experienced asthma exacerbations after one guided BT compared with 73% after three unguided BTs ( P  = 0.028). Conclusions:  Results of this pilot study suggest that similar short-term improvements can be achieved with one BT treatment guided by  129 Xe MRI when compared with standard three-treatment-session BT with fewer periprocedure adverse events.",2020,"MEASUREMENTS AND MAIN RESULTS


There was no significant difference in quality of life after one guided compared to three unguided BTs (ΔAQLQ guided= 0.91[95% CI, 0.28 to 1.53], unguided=1.49 [95% CI, 0.84 to 2.14] P=0.201).",['Thirty subjects with severe asthma were imaged with volumetric CT and 129Xe MRI to quantitate segmental ventilation defects'],"['standard three-session BT (unguided', '129 Xe Magnetic Resonance Imaging', 'Single-Session Bronchial Thermoplasty Guided by']","['quality of life', 'percent of poorly/non-ventilated lung', 'change in Asthma Quality of Life Questionnaire (AQLQ) score', 'asthma exacerbations', 'AQLQ and asthma control tests (ACT']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0860888', 'cui_str': 'Spiral computed tomography scan'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3854686', 'cui_str': 'Thermoplasty of bronchus'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}]",30.0,0.171046,"MEASUREMENTS AND MAIN RESULTS


There was no significant difference in quality of life after one guided compared to three unguided BTs (ΔAQLQ guided= 0.91[95% CI, 0.28 to 1.53], unguided=1.49 [95% CI, 0.84 to 2.14] P=0.201).","[{'ForeName': 'Chase S', 'Initials': 'CS', 'LastName': 'Hall', 'Affiliation': 'University of Kansas School of Medicine, Kansas City, Kansas.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Quirk', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Goss', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Lew', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Kozlowski', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Thomen', 'Affiliation': 'University of Missouri, Columbia, Missouri.'}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Woods', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, Virginia; and.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Mugler', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, Virginia; and.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Gallagher', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Ken B', 'Initials': 'KB', 'LastName': 'Schechtman', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Iulian C', 'Initials': 'IC', 'LastName': 'Ruset', 'Affiliation': 'Xemed LLC, Durham, New Hampshire.'}, {'ForeName': 'F William', 'Initials': 'FW', 'LastName': 'Hersman', 'Affiliation': 'Xemed LLC, Durham, New Hampshire.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Castro', 'Affiliation': 'University of Kansas School of Medicine, Kansas City, Kansas.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201905-1021OC']
1145,32510984,Genotype-Guided Dosing of Warfarin in Chinese Adults: A Multicenter Randomized Clinical Trial.,"BACKGROUND


Warfarin is an effective treatment for thromboembolic disease but has a narrow therapeutic index; optimal anticoagulation dosage can differ tremendously among individuals. We aimed to evaluate whether genotype-guided warfarin dosing is superior to routine clinical dosing for the outcomes of interest in Chinese patients.
METHODS


We conducted a multicenter, randomized, single-blind, parallel-controlled trial from September 2014 to April 2017 in 15 hospitals in China. Eligible patients were ≥18 years of age, with atrial fibrillation or deep vein thrombosis without previous treatment of warfarin or a bleeding disorder. Nine follow-up visits were performed during the 12-week study period. The primary outcome measure was the percentage of time in the therapeutic range of the international normalized ratio during the first 12 weeks after starting warfarin therapy.
RESULTS


A total of 660 participants were enrolled and randomly assigned to a genotype-guided dosing group or a control group under standard dosing. The genotype-guided dosing group had a significantly higher percentage of time in the therapeutic range than the control group (58.8% versus 53.2% [95% CI of group difference, 1.1-10.2];  P =0.01). The genotype-guided dosing group also achieved the target international normalized ratio sooner than the control group. In subgroup analyses, warfarin normal sensitivity group had an even higher percentage of time in the therapeutic range during the first 12 weeks compared with the control group (60.8% versus 48.9% [95% CI, 1.1-24.4]). The incidence of adverse events was low in both groups.
CONCLUSIONS


The outcomes of genotype-guided warfarin dosing were superior to those of clinical standard dosing. These findings raise the prospect of precision warfarin treatment in China. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02211326.",2020,"The genotype-guided dosing group had a significantly higher %TTR than the control group (58.8% vs. 53.2%, 95% confidence interval of group difference (95%CI): 1.1-10.2; P=0.01).","['Chinese patients', '660 participants', 'Eligible patients were 18 years or older, with atrial fibrillation or deep vein thrombosis without previous treatment of warfarin or a bleeding disorder', 'September 2014 to April 2017 in 15 hospitals in China', 'Chinese Adults']","['genotype-guided dosing group or a control group under standard dosing', 'Genotype-Guided Dosing of Warfarin', 'genotype-guided warfarin', '  - Warfarin']","['percentage of time in the therapeutic range (%TTR) of the international normalized ratio (INR', 'adverse events']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0460097', 'cui_str': 'Within therapeutic range'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",660.0,0.107551,"The genotype-guided dosing group had a significantly higher %TTR than the control group (58.8% vs. 53.2%, 95% confidence interval of group difference (95%CI): 1.1-10.2; P=0.01).","[{'ForeName': 'Chengxian', 'Initials': 'C', 'LastName': 'Guo', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Kuang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Honghao', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Department of Clinical Pharmacology, Xiangya Hospital (H.Z., Xiaoping Chen), Central South University, Changsha, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Pei', 'Affiliation': 'Department of Pharmacy (C.G., Q.P., L.H., Jinfu Peng, G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Jingle', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The Third Xiangya Hospital (J.L., W.J., X.T., Q.Y., S.T., Xiaoyan Wang, J.C., S.J.), Central South University, Changsha, China.'}, {'ForeName': 'Weihong', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, The Third Xiangya Hospital (J.L., W.J., X.T., Q.Y., S.T., Xiaoyan Wang, J.C., S.J.), Central South University, Changsha, China.'}, {'ForeName': 'Chee M', 'Initials': 'CM', 'LastName': 'Ng', 'Affiliation': 'College of Pharmacy, University of Kentucky, Lexington (C.M.N.).'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Pharmacology, Xiangya Hospital (H.Z., Xiaoping Chen), Central South University, Changsha, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology (Y.H.), Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Pharmacy, Peking University First Hospital (Y.C.), Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health, Center on the Early Life Origins of Disease, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD (Xiaobin Wang).'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Wanying', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Miao', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Zaixin', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiology, Third Hospital of Changsha, China (Y.Z.).'}, {'ForeName': 'Zewei', 'Initials': 'Z', 'LastName': 'Ouyang', 'Affiliation': 'Department of Cardiology, Shaoyang Central Hospital, China (Z.O., X. Shi).'}, {'ForeName': 'Xiangjiang', 'Initials': 'X', 'LastName': 'Shi', 'Affiliation': 'Department of Cardiology, Shaoyang Central Hospital, China (Z.O., X. Shi).'}, {'ForeName': 'Chunmei', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Shaoyang, China (C.L., Z.P.).""}, {'ForeName': 'Zijing', 'Initials': 'Z', 'LastName': 'Peng', 'Affiliation': ""Department of Cardiology, The First People's Hospital of Shaoyang, China (C.L., Z.P.).""}, {'ForeName': 'Guozuo', 'Initials': 'G', 'LastName': 'Xiong', 'Affiliation': 'Department of Vascular Surgery (G.X.), The Second Affiliated Hospital, University of South China, Hengyang.'}, {'ForeName': 'Gaofeng', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Department of Cardiology (G.Z.), The Second Affiliated Hospital, University of South China, Hengyang.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Department of Cardiology, Xiangtan Central Hospital, China (J.Z.).'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Dai', 'Affiliation': 'Department of Cardiology, Changsha Central Hospital, China (H.D.).'}, {'ForeName': 'Jianqiang', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': ""Department of Cardiology, Hunan Provincial People's Hospital, China (Jianqiang Peng).""}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Third Hospital of Changsha, China (Y.Z.).'}, {'ForeName': 'Fanghua', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ""Department of Cardiology, First People's Hospital of Xiangtan City, China (F.X.).""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, First Affiliated Hospital of University of South China, Hengyang (J.W.).'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Chenzhou First People's Hospital, China (Xiaoliang Chen).""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Gong', 'Affiliation': 'Department of Cardiology, The Fourth Hospital of Changsha, China (H.G.).'}, {'ForeName': 'Zhiyuan', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Loudi Central Hospital, China (Z. Yang).'}, {'ForeName': 'Xianming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Yiyang Central Hospital, China (X. Wu).'}, {'ForeName': 'Qiulian', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': 'School of Mathematics and Statistics (Q.F., L.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'School of Mathematics and Statistics (Q.F., L.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Haigang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Changsha Medical University, China (H.L.).'}, {'ForeName': 'Hongyi', 'Initials': 'H', 'LastName': 'Tan', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiology, The Third Xiangya Hospital (J.L., W.J., X.T., Q.Y., S.T., Xiaoyan Wang, J.C., S.J.), Central South University, Changsha, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, The Third Xiangya Hospital (J.L., W.J., X.T., Q.Y., S.T., Xiaoyan Wang, J.C., S.J.), Central South University, Changsha, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'Department of Cardiology, The Third Xiangya Hospital (J.L., W.J., X.T., Q.Y., S.T., Xiaoyan Wang, J.C., S.J.), Central South University, Changsha, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The Third Xiangya Hospital (J.L., W.J., X.T., Q.Y., S.T., Xiaoyan Wang, J.C., S.J.), Central South University, Changsha, China.'}, {'ForeName': 'Yuxia', 'Initials': 'Y', 'LastName': 'Xiang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Department of Cardiology, The Third Xiangya Hospital (J.L., W.J., X.T., Q.Y., S.T., Xiaoyan Wang, J.C., S.J.), Central South University, Changsha, China.'}, {'ForeName': 'Shanjie', 'Initials': 'S', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, The Third Xiangya Hospital (J.L., W.J., X.T., Q.Y., S.T., Xiaoyan Wang, J.C., S.J.), Central South University, Changsha, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Pharmacy (C.G., Q.P., L.H., Jinfu Peng, G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Jinfu', 'Initials': 'J', 'LastName': 'Peng', 'Affiliation': 'Department of Pharmacy (C.G., Q.P., L.H., Jinfu Peng, G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Gong', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Zou', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}, {'ForeName': 'Guoping', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Center of Clinical Pharmacology, the Third Xiangya Hospital (C.G., Y.K., H.Y., J.Y., X. Sun, W.Y., P.C., D.M., W.L., H.T., Z.H., Y.X., J.H., Xiaomin Wang, L.G., C.Z., G.Y.), Central South University, Changsha, China.'}]",Circulation. Genomic and precision medicine,['10.1161/CIRCGEN.119.002602']
1146,32524862,Effect of clarithromycin pre-treatment on the pharmacokinetics of metoclopramide after their simultaneous oral intake.,"OBJECTIVE


The objective of this study was to assess the influence of enzyme suppression on the values of various pharmacokinetic factors of orally administered metoclopramide.
METHOD


This study was conducted in two phases and a 4-week duration was adopted for drug washout. This randomized study involved 12 healthy human volunteers who received a single oral dose of metoclopramide 20 mg. After the washout period, volunteers received clarithromycin 500 mg two times per day for consecutive 5 days. On test day (fifth day), a single oral dose of metoclopramide 20 mg was also given to the volunteers, and collection of blood samples was conducted at pre-decided time points. Various pharmacokinetic parameters such as C max,  T max , and AUC 0-∞  of metoclopramide were determined by analyzing the blood samples using a validated HPLC-UV method.
RESULTS


Clarithromycin increased the mean values of C max , AUC 0-∞ , and T 1/2  of metoclopramide by 46%, 78.6%, and 9.8%, respectively.
CONCLUSION


Clarithromycin noticeably increased the concentration of plasma metoclopramide. This study's results provide  in vivo  confirmation of the CYP3A4 involvement in metoclopramide metabolism, in addition to CYP2D6. Therefore, metoclopramide pharmacokinetics may be clinically affected by clarithromycin and other potent enzyme inhibitors.",2020,"RESULTS


Clarithromycin increased the mean values of C max , AUC 0-∞  and T 1/2  of metoclopramide by 46%, 78.6%, and 9.8%, respectively.
",['twelve healthy human volunteers who received a single oral dose of'],"['metoclopramide 20 mg', 'metoclopramide', 'clarithromycin', 'Clarithromycin']","['mean values of C max , AUC 0-∞  and T 1/2  of metoclopramide', 'concentration of plasma metoclopramide', 'C max,  T max , and AUC 0-∞  of metoclopramide']","[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",12.0,0.034377,"RESULTS


Clarithromycin increased the mean values of C max , AUC 0-∞  and T 1/2  of metoclopramide by 46%, 78.6%, and 9.8%, respectively.
","[{'ForeName': 'Iram', 'Initials': 'I', 'LastName': 'Kaukab', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Bahauddin Zakariya University , Multan, Pakistan.'}, {'ForeName': 'Syed Nisar Hussain', 'Initials': 'SNH', 'LastName': 'Shah', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Bahauddin Zakariya University , Multan, Pakistan.'}, {'ForeName': 'Zelal Jaber', 'Initials': 'ZJ', 'LastName': 'Kharaba', 'Affiliation': 'Department of Clinical Sciences, College of Pharmacy, Al-Ain University of Science and Technology , Abu Dhabi, United Arab Emirates.'}, {'ForeName': 'Manal Ali', 'Initials': 'MA', 'LastName': 'Buabeid', 'Affiliation': 'Department of Clinical Sciences, Ajman University , United Arab Emirates.'}, {'ForeName': 'Yaseen Abd', 'Initials': 'YA', 'LastName': 'Alfoteih', 'Affiliation': 'Department of Dental Surgery, City University College of Ajman , Ajman, United Arab Emirates.'}, {'ForeName': 'Ghulam', 'Initials': 'G', 'LastName': 'Murtaza', 'Affiliation': 'Department of Pharmacy, COMSATS Institute of Information Technology , Lahore, Pakistan.'}]",Expert opinion on drug metabolism & toxicology,['10.1080/17425255.2020.1779699']
1147,32526502,The effect of rumination and distraction on auditory hallucinatory experiences: An analogue experimental study.,"BACKGROUND AND OBJECTIVES


The cognitive model of voices suggests that negative appraisals of hallucinatory experiences result in responses, such as rumination, which maintain voice-hearing. Our principal aim was to investigate the effect of rumination on the frequency of voice-hearing.
METHODS


A two-group randomised experimental design was employed using a non-clinical sample. A total of 106 participants completed baseline measures of trait rumination, hallucination-proneness, mood and state negative affect, and were presented with a voice-hearing paradigm. False feedback designed to cause a negative interpretation of auditory intrusions was provided and participants were randomly allocated to either a distraction or rumination condition. Participants performed the auditory task for a second time, and the total number of false alarms and distress scores were compared between groups.
RESULTS


A Mann-Whitney U test revealed that the manipulation of rumination was successful (p = 0.007). We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores.
LIMITATIONS


Findings largely relate to a female undergraduate psychology sample.
CONCLUSION


Results of this non-clinical study do not support the hypothesis that rumination leads to an increase in the frequency of voice-hearing on a laboratory task.",2020,"We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores.
","['106 participants completed baseline measures of trait rumination, hallucination-proneness, mood and state negative affect, and were presented with a voice-hearing paradigm', 'auditory hallucinatory experiences', 'female undergraduate psychology sample']","['distraction or rumination condition', 'rumination and distraction']","['distress', 'auditory task', 'total number of false alarms and distress scores', 'frequency of voice-hearing']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]",106.0,0.0413272,"We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores.
","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hartley', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Pennine Care NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Morrison', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Bucci', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK. Electronic address: sandra.bucci@manchester.ac.uk.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101592']
1148,32526534,The RICH LIFE Project: A cluster randomized pragmatic trial comparing the effectiveness of health system only vs. health system Plus a collaborative/stepped care intervention to reduce hypertension disparities.,"Disparities in the control of hypertension and other cardiovascular disease risk factors are well-documented in the United States, even among patients seen regularly in the healthcare system. Few existing approaches explicitly address disparities in hypertension care and control. This paper describes the RICH LIFE Project (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) design.
METHODS


RICH LIFE is a two-arm, cluster-randomized trial, comparing the effectiveness of enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC), for improving blood pressure (BP) control and patient activation and reducing disparities in BP control among 1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates; and quarterly webinars in management practices, quality improvement and disparities reduction. Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults). The primary clinical outcome is BP control (<140/90 mm Hg) at 12 months. The primary patient-reported outcome is change from baseline in self-reported patient activation at 12 months.
DISCUSSION


This study will provide knowledge about the feasibility of leveraging existing resources in routine primary care and potential benefits of adding supportive community-facing roles to improve hypertension care and reduce disparities.
TRIAL REGISTRATION


Clinicaltrials.govNCT02674464.",2020,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,['1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania'],"['RICH LIFE Project', 'enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC', 'SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates', 'health system only vs health system plus a collaborative/stepped care intervention']","['blood pressure (BP) control and patient activation', 'hypertension disparities', 'BP control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0348668', 'cui_str': 'Other and unspecified disorders of circulatory system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",1890.0,0.09569,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,"[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cooper', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: lisa.cooper@jhmi.edu.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Marsteller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Carson', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Dietz', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Romsai T', 'Initials': 'RT', 'LastName': 'Boonyasai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Chidinma A', 'Initials': 'CA', 'LastName': 'Ibe', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Deidra C', 'Initials': 'DC', 'LastName': 'Crews', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Cheryl R', 'Initials': 'CR', 'LastName': 'Dennison-Himmelfarb', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Lubomski', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Tanjala S', 'Initials': 'TS', 'LastName': 'Purnell', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Hill-Briggs', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.001']
1149,32530765,Prospective Evaluation of Radiation Dose Escalation in Patients With High-Risk Neuroblastoma and Gross Residual Disease After Surgery: A Report From the Children's Oncology Group ANBL0532 Study.,"PURPOSE


A primary objective of the Children's Oncology Group (COG) ANBL0532 phase III study was to assess the effect of increasing local dose of radiation to a residual primary tumor on the cumulative incidence of local progression (CILP) in patients with high-risk neuroblastoma.
PATIENTS AND METHODS


Newly diagnosed patients with high-risk neuroblastoma were randomly assigned or assigned to receive single or tandem autologous stem-cell transplantation (SCT) after induction chemotherapy. Local control consisted of surgical resection during induction chemotherapy and radiotherapy after last SCT. Patients received 21.6 Gy to the preoperative primary tumor volume. For patients with incomplete surgical resection, an additional boost of 14.4 Gy was delivered to the gross residual tumor, for a total dose of 36 Gy. CILP (primary end point) and event-free (EFS) and overall survival (OS; secondary end points) were compared with the COG A3973 historical cohort, in which all patients received single SCT and 21.6 Gy without a boost.
RESULTS


For all patients in ANBL0532 receiving radiotherapy (n = 323), 5-year CILP, EFS, and OS rates were 11.2% ± 1.8%, 56.2% ± 3.4%, and 68.4% ± 3.2% compared with 7.1% ± 1.4% ( P  = .0590), 47.0% ± 3.5% ( P  = .0090), and 57.4% ± 3.5% ( P  = .0088) for all patients in A3973 receiving radiotherapy (n = 328), respectively. Five-year CILP, EFS, and OS rates for patients in A3973 with incomplete resection and radiotherapy (n = 47) were 10.6% ± 4.6%, 48.9% ± 10.1%, and 56.9% ± 10.0%, respectively. In comparison, 5-year CILP, EFS, and OS rates for patients in ANBL0532 who were randomly assigned or assigned to single SCT and received boost radiotherapy (n = 74) were 16.3% ± 4.3% ( P  = .4126), 50.9% ± 7.0% ( P  = .5084), and 68.1% ± 6.7% ( P  = .2835), respectively.
CONCLUSION


Boost radiotherapy to gross residual tumor present at the end of induction did not significantly improve 5-year CILP. These results highlight the need for new strategies to decrease the risk of locoregional failure.",2020,"For all patients in ANBL0532 receiving radiotherapy (n = 323), 5-year CILP, EFS, and OS rates were 11.2% ± 1.8%, 56.2% ± 3.4%, and 68.4% ± 3.2% compared with 7.1% ± 1.4% ( P  = .0590), 47.0% ± 3.5% ( P  = .0090), and 57.4% ± 3.5% ( P  = .0088) for all patients in A3973 receiving radiotherapy (n = 328), respectively.","['Patients With High-Risk Neuroblastoma and Gross Residual Disease', 'Newly diagnosed patients with high-risk neuroblastoma', 'patients with high-risk neuroblastoma']","['radiotherapy', 'ANBL0532 receiving radiotherapy', 'surgical resection during induction chemotherapy and radiotherapy', 'boost radiotherapy', 'Radiation Dose Escalation', 'single or tandem autologous stem-cell transplantation (SCT) after induction chemotherapy', 'Boost radiotherapy']","['EFS, and OS rates', 'risk of locoregional failure', 'CILP (primary end point) and event-free (EFS) and overall survival', 'local progression (CILP', '5-year CILP, EFS, and OS rates', '5-year CILP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C2919491', 'cui_str': 'Boost radiation therapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",47.0,0.0978828,"For all patients in ANBL0532 receiving radiotherapy (n = 323), 5-year CILP, EFS, and OS rates were 11.2% ± 1.8%, 56.2% ± 3.4%, and 68.4% ± 3.2% compared with 7.1% ± 1.4% ( P  = .0590), 47.0% ± 3.5% ( P  = .0090), and 57.4% ± 3.5% ( P  = .0088) for all patients in A3973 receiving radiotherapy (n = 328), respectively.","[{'ForeName': 'Kevin X', 'Initials': 'KX', 'LastName': 'Liu', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham & Women's Hospital, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Naranjo', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, University of Florida, Gainesville, FL.""}, {'ForeName': 'Fan F', 'Initials': 'FF', 'LastName': 'Zhang', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, Monrovia, CA.""}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'DuBois', 'Affiliation': ""Department of Pediatric Oncology, Dana-Farber/Boston Children's Cancer and Blood Disorders Center and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Steve E', 'Initials': 'SE', 'LastName': 'Braunstein', 'Affiliation': 'Department of Radiation Oncology, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Stephan D', 'Initials': 'SD', 'LastName': 'Voss', 'Affiliation': ""Department of Radiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Geetika', 'Initials': 'G', 'LastName': 'Khanna', 'Affiliation': ""Department of Radiology, St Louis Children's Hospital, St Louis, MO.""}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'London', 'Affiliation': ""Department of Pediatric Oncology, Dana-Farber/Boston Children's Cancer and Blood Disorders Center and Harvard Medical School, Boston, MA.""}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Doski', 'Affiliation': ""Department of Surgery/Pediatric Surgery Division, University of Texas Health Science Center, San Rosa Children's Hospital, San Antonio, TX.""}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Geiger', 'Affiliation': ""Section of Pediatric Surgery, Department of Surgery, C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI.""}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Kreissman', 'Affiliation': 'Department of Pediatrics, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Stephan A', 'Initials': 'SA', 'LastName': 'Grupp', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Diller', 'Affiliation': ""Department of Pediatric Oncology, Dana-Farber/Boston Children's Cancer and Blood Disorders Center and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle, WA.""}, {'ForeName': 'Daphne A', 'Initials': 'DA', 'LastName': 'Haas-Kogan', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham & Women's Hospital, Boston Children's Hospital, Harvard Medical School, Boston, MA.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03316']
1150,32538014,[Light and heat of moxibustion for knee osteoarthritis：a multi-center randomized controlled trial].,"OBJECTIVE


To explore the clinical therapeutic effect of light and heat of moxibustion for knee osteoarthritis (KOA).
METHODS


A total of 216 patients with KOA were randomized into a traditional moxibustion group (72 cases, 8 cases dropped off), a moxibustion light group (72 cases, 9 cases dropped off) and a moxibustion heat group (72 cases, 10 cases dropped off).The special light-heat separation moxibustion cup was applied, the patients in the traditional moxibustion group received the treatment of moxibustion, the patients in the moxibustion light group received the treatment of moxibustion light and the patients in the moxibustion heat group received the treatment of moxibustion heat. The acupoint selection of the three groups was Neixiyan (EX-LE 4), Dubi (ST 35) and Zusanli (ST 36), the treatment was given 20 min each time, 3 times a week, 4 weeks were required totally, and the follow-up surveys were made 4 and 8 weeks after treatment. The scores of Western Ontario and McMaster University osteoarthritis index (WOMAC) and visual analogue scale (VAS) were observed before treatment, after 2 and 4 weeks of treatment, 4 and 8 weeks after treatment. The therapeutic effects were evaluated according to the criterion of patient global assessment (PGA) after 4 weeks of treatment and 8 weeks after treatment.
RESULTS


Compared with before treatment, the pain scores, stiffness scores, physical function scores and total scores of WOMAC were reduced after 2, 4 weeks of treatment and 4 weeks after treatment in the three groups ( P <0.05). The pain scores, stiffness scores, physical function scores and total scores of WOMAC were reduced 8 weeks after treatment in the traditional moxibustion group and the moxibustion heat group ( P <0.05). The stiffness score, physical function score and total score of WOMAC were reduced 8 weeks after treatment in the moxibustion light group ( P <0.05). The pain score, physical function score and total score of WOMAC in the traditional moxibustion group after 4 weeks of treatment were lower than the moxibustion light group ( P <0.05). Compared with before treatment, the VAS scores were reduced after 2, 4 weeks of treatment and 4 , 8 weeks after treatment in the three groups ( P <0.05). The improvement rates in the traditional moxibustion group and the moxibustion heat group after 4 weeks of treatment and 8 weeks after treatment were superior to the moxibustion light group ( P <0.05).
CONCLUSION


The light and heat of moxibustion have therapeutic effect for KOA, and the therapeutic effect of moxibustion heat is superior to moxibustion light.",2020,"The pain scores, stiffness scores, physical function scores and total scores of WOMAC were reduced 8 weeks after treatment in the traditional moxibustion group and the moxibustion heat group ( P <0.05).","['216 patients with KOA', 'knee osteoarthritis (KOA']","['moxibustion heat group', 'traditional moxibustion', 'moxibustion light group', 'moxibustion, the patients in the moxibustion light group received the treatment of moxibustion light and the patients in the moxibustion heat group received the treatment of moxibustion heat', 'light and heat of moxibustion', 'Light and heat of moxibustion', 'special light-heat separation moxibustion cup']","['scores of Western Ontario and McMaster University osteoarthritis index (WOMAC) and visual analogue scale (VAS', 'stiffness score, physical function score and total score of WOMAC', 'pain scores, stiffness scores, physical function scores and total scores of WOMAC', 'improvement rates', 'pain score, physical function score and total score of WOMAC', 'VAS scores']","[{'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",216.0,0.0184345,"The pain scores, stiffness scores, physical function scores and total scores of WOMAC were reduced 8 weeks after treatment in the traditional moxibustion group and the moxibustion heat group ( P <0.05).","[{'ForeName': 'Mo', 'Initials': 'M', 'LastName': 'Liao', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Chengdu University of TCM, Chengdu 610075, Sichuan Province, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Chengdu University of TCM, Chengdu 610075, Sichuan Province, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Ding', 'Affiliation': 'Department of Acupuncture and Moxibustion, Luohe Hospital of TCM.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Zuo', 'Affiliation': 'Fourth Department of Acupuncture and Moxibustion, Shaanxi TCM Hospital.'}, {'ForeName': 'Ling-Ling', 'Initials': 'LL', 'LastName': 'Guo', 'Affiliation': 'Department of Acupuncture and Moxibustion, Zibo Central Hospital of Shangdong Province.'}, {'ForeName': 'Chun-Yan', 'Initials': 'CY', 'LastName': 'Gou', 'Affiliation': 'Department of Acupuncture and Moxibustion, Chongqing TCM Hospital.'}, {'ForeName': 'Cai-Rong', 'Initials': 'CR', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanjing TCM Hospital.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Chengdu University of TCM, Chengdu 610075, Sichuan Province, China.'}, {'ForeName': 'Shu-Guang', 'Initials': 'SG', 'LastName': 'Yu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Chengdu University of TCM, Chengdu 610075, Sichuan Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20200205-k0003']
1151,32540337,Consolidation cetuximab after concurrent triplet radiochemotherapy+cetuximab in patients with advanced head and neck cancer: A randomized phase II study.,"BACKGROUND AND PURPOSE


Preclinical data suggest that cetuximab should be continued after end of concurrent radiotherapy+cetuximab due to its efficacy against residual tumor cells in the irradiated tumor bed. Based on this concept the phase II add-on cetuximab (AOC) study was designed.
MATERIALS AND METHODS


Altogether 63 patients with advanced head and neck cancer were treated with radiochemotherapy (70 Gy, cisplatin 40 mg/m 2  weekly) in combination with concurrent cetuximab (loading dose 400 mg/m 2 , then 250 mg/m 2  weekly). Thereafter patients were randomized to cetuximab consolidation (500 mg/m 2  biweekly × 6) or no further treatment. The primary endpoint was the 2-year locoregional control (LRC) rate. As translational research endpoints serum markers were analyzed before and during treatment and CT-based quantitative image analysis (radiomics) was performed.
RESULTS


Median follow-up was 24 months. The 2-year LRC rates were 67.9% and 67.7% in the treatment arms with and without consolidation cetuximab, respectively. Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p ≤ 0.05). A radiomics model consisting of two radiomics features could be built showing that higher entropy and higher complexity of tumor Hounsfield unit distribution indicates worse LRC (concordance index 0.66). No correlation was found between biological and imaging markers.
CONCLUSIONS


There was no evidence that consolidation cetuximab would improve the 2-year LRC rate. Prognostic biological and imaging markers could be identified for the overall patient cohort. Studies with larger patient numbers are needed to correlate biological and imaging markers.",2020,"Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05).","['Altogether 63 patients with advanced head and neck cancer', 'patients with advanced head and neck cancer']","['radiochemotherapy + cetuximab', 'radiochemotherapy (70 Gy, cisplatin 40mg/m2 weekly) in combination with concurrent cetuximab', 'Consolidation cetuximab', 'radiotherapy + cetuximab', 'cetuximab consolidation']","['2-year LRC rates', '2-year LRC rate', '2-year locoregional control (LRC) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",63.0,0.0261113,"Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05).","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Riesterer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Center for Radiation Oncology KSA-KSB, Cantonal Hospital Aarau, Switzerland. Electronic address: oliver.riesterer@ksa.ch.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Pruschy', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Bender', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bogowicz', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tanadini-Lang', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Stieb', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Kaja', 'Initials': 'K', 'LastName': 'Bertogg', 'Affiliation': 'Clinical Trials Center, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Weber', 'Affiliation': 'Clinical Trials Center, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Ikenberg', 'Affiliation': 'Institute of Pathology and Molecular Pathology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Huber', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Zurich, University of Zurich, Switzerland; Department of Otorhinolaryngology, Cantonal Hospital St. Gallen, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Otorhinolaryngology Clinic Bethanien, Zurich, Switzerland.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Bredell', 'Affiliation': 'Clinic for Oral and Maxillofacial Surgery, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Veit-Haibach', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Zurich, Switzerland; Department of Diagnostic and Interventional Radiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Rordorf', 'Affiliation': 'Department of Medical Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Held', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, Department of Biostatistics, University of Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Glanzmann', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Department of Radiation Oncology, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Studer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Department of Radiation Oncology, Cantonal Hospital Lucerne, Switzerland.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.06.011']
1152,32540878,Ultrasonographic needle tip tracking for in-plane infraclavicular brachialis plexus blocks: a randomized controlled volunteer study.,"BACKGROUND


Onvision is a new technology for needle tip detection and tracking in ultrasound-guided regional anesthesia. The system consists of a piezoelectric sensor close to the needle tip and an electronic console integrated in the ultrasound system. The needle tip is visualized by a green circle on the ultrasound screen. The aim of the study was to investigate the effect of the new needle tip tracking technology on in-plane infraclavicular plexus blocks.
METHODS


The study was a randomized, controlled, observer blinded cross-over trial in 26 healthy volunteers. Two specialists in anesthesiology performed an ultrasound-guided infraclavicular lateral sagittal brachial plexus block with and without needle tip tracking. Primary outcome was procedure time, measured from insertion of the needle until local anesthesia injection was completed. Secondary outcome measures included the number of hand movements and path lengths (assessed by hand motion analysis), block success rate, onset time and duration, discomfort experienced by the volunteers, and the anesthesiologists' confidence as to whether their block would be successful or not.
RESULTS


Mean (SD) procedure time was 183.0 (56.1) s with and 206.8 (56.2) s without needle tip tracking (p=0.16). There were no significant differences in any of the secondary outcomes. Two volunteers' experienced Horner syndrome after blocks without needle tip tracking. No other adverse events occurred during the study.
CONCLUSION


Our study on needle tip tracking for infraclavicular blocks did not reveal any significant differences between active needle tip tracking and the control procedures, neither for primary outcome nor secondary outcome measurements.
TRIAL REGISTRATION NUMBER


NCT03631914.",2020,"Our study on needle tip tracking for infraclavicular blocks did not reveal any significant differences between active needle tip tracking and the control procedures, neither for primary outcome nor secondary outcome measurements.
",['26 healthy volunteers'],"['new needle tip tracking technology', 'Ultrasonographic needle tip tracking', 'ultrasound-guided infraclavicular lateral sagittal brachial plexus block with and without needle tip tracking']","['Horner syndrome', 'Mean (SD) procedure time', 'adverse events', ""number of hand movements and path lengths (assessed by hand motion analysis), block success rate, onset time and duration, discomfort experienced by the volunteers, and the anesthesiologists' confidence as to whether their block would be successful or not"", 'procedure time, measured from insertion of the needle until local anesthesia injection']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0230108', 'cui_str': 'Infraclavicular region structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}]","[{'cui': 'C0019937', 'cui_str': 'Cervical sympathetic paralysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0449770', 'cui_str': 'Measured from'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",26.0,0.0592287,"Our study on needle tip tracking for infraclavicular blocks did not reveal any significant differences between active needle tip tracking and the control procedures, neither for primary outcome nor secondary outcome measurements.
","[{'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Kåsine', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Research and Development, Oslo University Hospital, Oslo, Norway trikaa@ous-hf.no.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Romundstad', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Anesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Rosseland', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Research and Development, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Morten Wang', 'Initials': 'MW', 'LastName': 'Fagerland', 'Affiliation': 'Oslo Centre for Biostatics and Epidemiology (OCBE) Research Support Services, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kessler', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Orthopedic University Hospital Friedrichsheim, Frankfurt am Main, Hessen, Germany.'}, {'ForeName': 'Ivar Nagelgaard', 'Initials': 'IN', 'LastName': 'Omenås', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Anesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Holmberg', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Anesthesiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Axel R', 'Initials': 'AR', 'LastName': 'Sauter', 'Affiliation': 'Division of Emergencies and Critical Care, Department of Research and Development, Oslo University Hospital, Oslo, Norway.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101349']
1153,32540886,"Understanding implementation success: protocol for an in-depth, mixed-methods process evaluation of a cluster randomised controlled trial testing methods to improve detection of Lynch syndrome in Australian hospitals.","INTRODUCTION


In multisite intervention trials, implementation success often varies widely across settings. Process evaluations are crucial to interpreting trial outcomes and understanding contextual factors and causal chains necessary for successful implementation. Lynch syndrome is a hereditary cancer predisposition conferring an increased risk of colorectal, endometrial and other cancer types. Despite systematic screening protocols to identify Lynch syndrome, the condition remains largely underdiagnosed. The Hide and Seek Project ('HaSP') is a cluster randomised controlled trial determining the effectiveness of two approaches to improving Lynch syndrome detection at eight Australian hospital networks. To enhance widespread implementation of optimal Lynch syndrome identification, there is a need to understand not only what works, but also why, in what contexts, and at what costs. Here we describe an in-depth investigation of factors influencing successful implementation of procedures evaluated in the HaSP trial.
METHODS AND ANALYSIS


A mixed-methods, theory-driven process evaluation will be undertaken in parallel to the HaSP trial. Data will include: interviews of Implementation Leads and Lynch syndrome stakeholders, pre-post implementation questionnaires, audio analysis of meetings and focus groups, observation of multidisciplinary team meetings, fidelity checklists and project log analysis. Results will be triangulated and coded, drawing on the Theoretical Domains Framework, Consolidated Framework for Implementation Research and Proctor's implementation outcomes.
ETHICS AND DISSEMINATION


Use of a theory-based process evaluation will enhance interpretation and generalisability of HaSP trial findings, and contribute to the implementation research field by furthering understanding of the conditions necessary for implementation success. Ethical approval has been granted and results will be disseminated via publications in peer-reviewed journals and conference presentations. At trial completion, key findings will be fed back to sites to enable refinement of intervention strategies, both in the context of Lynch syndrome and for the possible generalisability of intervention components in other genetic and broader clinical specialties.
HASP TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (Identifier: ACTRN12618001072202). Registered 27 June 2018. http://www.ANZCTR.org.au/ACTRN12618001072202.aspx.",2020,The Hide and Seek Project ('HaSP') is a cluster randomised controlled trial determining the effectiveness of two approaches to improving Lynch syndrome detection at eight Australian hospital networks.,['Australian hospitals'],[],[],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],[],,0.147946,The Hide and Seek Project ('HaSP') is a cluster randomised controlled trial determining the effectiveness of two approaches to improving Lynch syndrome detection at eight Australian hospital networks.,"[{'ForeName': 'April', 'Initials': 'A', 'LastName': 'Morrow', 'Affiliation': 'Cancer Council New South Wales, Woolloomooloo, New South Wales, Australia april.morrow@nswcc.org.au.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Tucker', 'Affiliation': 'Hereditary Cancer Clinic, Prince of Wales Hospital and Community Health Services, Randwick, New South Wales, Australia.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Shaw', 'Affiliation': 'Research in Implementation Science and eHealth (RISe), Faculty of Health Sciences, University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Bonny', 'Initials': 'B', 'LastName': 'Parkinson', 'Affiliation': 'The Macquarie University Centre for the Health Economy, Macquarie University, Macquarie, New South Wales, Australia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Abraham', 'Affiliation': 'Melbourne School of Psychological Sciences, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Taylor', 'Affiliation': 'Cancer Council New South Wales, Woolloomooloo, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-033552']
1154,32542695,Differing Effects of Zoledronic Acid on Bone Microarchitecture and Bone Mineral Density in Men Receiving Androgen Deprivation Therapy: A Randomized Controlled Trial.,"Androgen deprivation therapy (ADT) given to men with prostate cancer causes rapid and severe sex steroid deficiency, leading to increased bone remodeling and accelerated bone loss. To examine the effects of a single dose of zoledronic acid on bone microarchitecture, we conducted a 2-year randomized placebo controlled trial in 76 men, mean age (interquartile range [IQR]) 67.8 years (63.8 to 73.9) with non-metastatic prostate cancer commencing adjuvant ADT; 39 were randomized to zoledronic acid and 37 to matching placebo. Bone microarchitecture was measured using high-resolution peripheral quantitative computed tomography (HR-pQCT). Using a mixed model, mean adjusted differences (MAD; 95% confidence interval [95% CI]) between the groups are reported as the treatment effect at several time points. Over 24 months, zoledronic acid showed no appreciable treatment effect on the primary outcomes for total volumetric bone mineral density (vBMD); radius (6.7 mg HA/cm 3  [-2.0 to 15.4], p = 0.21) and tibia (1.9 mg HA/cm 3  [-3.3 to 7.0], p = 0.87). Similarly, there were no between-group differences in other measures of microarchitecture, with the exception of a modest effect of zoledronic acid over placebo in total cortical vBMD at the radius over 12 months (17.3 mgHA/cm 3  [5.1 to 29.5]). In contrast, zoledronic acid showed a treatment effect over 24 months on areal bone mineral density (aBMD) by dual-energy X-ray absorptiometry (DXA) at all sites, including lumbar spine (0.10 g/cm 2  [0.07 to 0.13]), p < 0.001), and total hip (0.04 g/cm 2  [0.03 to 0.05], p < 0.001). Bone remodeling markers were initially suppressed in the treatment group then increased but remained lower relative to placebo (MADs at 24 months CTX -176 ng/L [-275 to -76], p < 0.001; P1NP -18 mg/L [-32 to -5], p < 0.001). These findings suggest that a single dose of zoledronic acid over 2 years is ineffective in preventing the unbalanced bone remodeling and severe microstructural deterioration associated with ADT therapy. © 2020 American Society for Bone and Mineral Research.",2020,"Over 24 months, zoledronic acid showed no appreciable treatment effect on the primary outcomes for total volumetric bone mineral density (vBMD); radius (6.7 mg HA/cm 3  [-2.0;15.4], p=0.21) and tibia (1.9 mg HA/cm 3  [-3.3;7.0], p=0.87).","['76 men, mean age [IQR] 67.8\u2009years [63.8;73.9] with non-metastatic prostate cancer commencing adjuvant ADT; 39 were randomised to', 'men with prostate cancer', 'men receiving androgen deprivation therapy']","['Androgen deprivation therapy (ADT', 'zoledronic acid', 'zoledronic acid over placebo', 'placebo']","['total cortical vBMD', 'total hip', 'bone microarchitecture and bone mineral density', 'Bone remodeling markers', 'total volumetric bone mineral density (vBMD); radius', 'lumbar spine', 'Bone microarchitecture']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4759295', 'cui_str': 'Non-metastatic prostate cancer'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0034627', 'cui_str': 'Bone structure of radius'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",76.0,0.38584,"Over 24 months, zoledronic acid showed no appreciable treatment effect on the primary outcomes for total volumetric bone mineral density (vBMD); radius (6.7 mg HA/cm 3  [-2.0;15.4], p=0.21) and tibia (1.9 mg HA/cm 3  [-3.3;7.0], p=0.87).","[{'ForeName': 'Ada S', 'Initials': 'AS', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Hoermann', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ghasem-Zadeh', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Alistair J', 'Initials': 'AJ', 'LastName': 'Tinson', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Ly', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Stefan V', 'Initials': 'SV', 'LastName': 'Milevski', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Daryl Lim', 'Initials': 'DL', 'LastName': 'Joon', 'Affiliation': 'Department of Radiation Oncology, Austin Health, Heidelberg, Australia.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Zajac', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Ego', 'Initials': 'E', 'LastName': 'Seeman', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Mathis', 'Initials': 'M', 'LastName': 'Grossmann', 'Affiliation': 'Department of Medicine (Austin Health), The University of Melbourne, Melbourne, Australia.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4106']
1155,32542748,"Prospective, randomized trial of treatment for mild ulnar neuropathy at the elbow.",,2020,,['mild ulnar neuropathy at the elbow'],[],[],"[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0154743', 'cui_str': 'Ulnar neuropathy'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}]",[],[],,0.0211104,,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Podnar', 'Affiliation': 'Institute of Clinical Neurophysiology, Division of Neurology, University Medical Center, Ljubljana, Slovenia.'}]",Muscle & nerve,['10.1002/mus.27005']
1156,27343257,Atomoxetine restores the response inhibition network in Parkinson's disease.,"Parkinson's disease impairs the inhibition of responses, and whilst impulsivity is mild for some patients, severe impulse control disorders affect ∼10% of cases. Based on preclinical models we proposed that noradrenergic denervation contributes to the impairment of response inhibition, via changes in the prefrontal cortex and its subcortical connections. Previous work in Parkinson's disease found that the selective noradrenaline reuptake inhibitor atomoxetine could improve response inhibition, gambling decisions and reflection impulsivity. Here we tested the hypotheses that atomoxetine can restore functional brain networks for response inhibition in Parkinson's disease, and that both structural and functional connectivity determine the behavioural effect. In a randomized, double-blind placebo-controlled crossover study, 19 patients with mild-to-moderate idiopathic Parkinson's disease underwent functional magnetic resonance imaging during a stop-signal task, while on their usual dopaminergic therapy. Patients received 40 mg atomoxetine or placebo, orally. This regimen anticipates that noradrenergic therapies for behavioural symptoms would be adjunctive to, not a replacement for, dopaminergic therapy. Twenty matched control participants provided normative data. Arterial spin labelling identified no significant changes in regional perfusion. We assessed functional interactions between key frontal and subcortical brain areas for response inhibition, by comparing 20 dynamic causal models of the response inhibition network, inverted to the functional magnetic resonance imaging data and compared using random effects model selection. We found that the normal interaction between pre-supplementary motor cortex and the inferior frontal gyrus was absent in Parkinson's disease patients on placebo (despite dopaminergic therapy), but this connection was restored by atomoxetine. The behavioural change in response inhibition (improvement indicated by reduced stop-signal reaction time) following atomoxetine correlated with structural connectivity as measured by the fractional anisotropy in the white matter underlying the inferior frontal gyrus. Using multiple regression models, we examined the factors that influenced the individual differences in the response to atomoxetine: the reduction in stop-signal reaction time correlated with structural connectivity and baseline performance, while disease severity and drug plasma level predicted the change in fronto-striatal effective connectivity following atomoxetine. These results suggest that (i) atomoxetine increases sensitivity of the inferior frontal gyrus to afferent inputs from the pre-supplementary motor cortex; (ii) atomoxetine can enhance downstream modulation of frontal-subcortical connections for response inhibition; and (iii) the behavioural consequences of treatment are dependent on fronto-striatal structural connections. The individual differences in behavioural responses to atomoxetine highlight the need for patient stratification in future clinical trials of noradrenergic therapies for Parkinson's disease.",2016,The behavioural change in response inhibition (improvement indicated by reduced stop-signal reaction time) following atomoxetine correlated with structural connectivity as measured by the fractional anisotropy in the white matter underlying the inferior frontal gyrus.,"[""Parkinson's disease"", ""19 patients with mild-to-moderate idiopathic Parkinson's disease underwent"", ""Parkinson's disease patients on""]","['atomoxetine', 'placebo', 'atomoxetine or placebo, orally', 'functional magnetic resonance imaging during a stop-signal task, while on their usual dopaminergic therapy', 'Atomoxetine']","['regional perfusion', 'response inhibition, gambling decisions and reflection impulsivity']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}]",19.0,0.109565,The behavioural change in response inhibition (improvement indicated by reduced stop-signal reaction time) following atomoxetine correlated with structural connectivity as measured by the fractional anisotropy in the white matter underlying the inferior frontal gyrus.,"[{'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Rae', 'Affiliation': '1 Department of Clinical Neurosciences, University of Cambridge, Cambridge, CB2 0SZ, UK 2 Medical Research Council Cognition and Brain Sciences Unit, Cambridge, CB2 7EF, UK.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Nombela', 'Affiliation': '1 Department of Clinical Neurosciences, University of Cambridge, Cambridge, CB2 0SZ, UK.'}, {'ForeName': 'Patricia Vázquez', 'Initials': 'PV', 'LastName': 'Rodríguez', 'Affiliation': '1 Department of Clinical Neurosciences, University of Cambridge, Cambridge, CB2 0SZ, UK.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': '1 Department of Clinical Neurosciences, University of Cambridge, Cambridge, CB2 0SZ, UK.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Hughes', 'Affiliation': '1 Department of Clinical Neurosciences, University of Cambridge, Cambridge, CB2 0SZ, UK 2 Medical Research Council Cognition and Brain Sciences Unit, Cambridge, CB2 7EF, UK.'}, {'ForeName': 'P Simon', 'Initials': 'PS', 'LastName': 'Jones', 'Affiliation': '1 Department of Clinical Neurosciences, University of Cambridge, Cambridge, CB2 0SZ, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Ham', 'Affiliation': '1 Department of Clinical Neurosciences, University of Cambridge, Cambridge, CB2 0SZ, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Rittman', 'Affiliation': '1 Department of Clinical Neurosciences, University of Cambridge, Cambridge, CB2 0SZ, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Coyle-Gilchrist', 'Affiliation': '1 Department of Clinical Neurosciences, University of Cambridge, Cambridge, CB2 0SZ, UK.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Regenthal', 'Affiliation': '3 Division of Clinical Pharmacology, Rudolf-Boehm-Institute of Pharmacology and Toxicology, University of Leipzig, Leipzig, 04107, Germany.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Sahakian', 'Affiliation': '4 Behavioural and Clinical Neuroscience Institute, Cambridge, CB2 3EB, UK 5 Department of Psychiatry, University of Cambridge, CB2 0SZ, Cambridge, UK.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Barker', 'Affiliation': '1 Department of Clinical Neurosciences, University of Cambridge, Cambridge, CB2 0SZ, UK.'}, {'ForeName': 'Trevor W', 'Initials': 'TW', 'LastName': 'Robbins', 'Affiliation': '4 Behavioural and Clinical Neuroscience Institute, Cambridge, CB2 3EB, UK 6 Department of Experimental Psychology, University of Cambridge, CB2 3EB, Cambridge, UK.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Rowe', 'Affiliation': '1 Department of Clinical Neurosciences, University of Cambridge, Cambridge, CB2 0SZ, UK 2 Medical Research Council Cognition and Brain Sciences Unit, Cambridge, CB2 7EF, UK 4 Behavioural and Clinical Neuroscience Institute, Cambridge, CB2 3EB, UK james.rowe@mrc-cbu.cam.ac.uk.'}]",Brain : a journal of neurology,['10.1093/brain/aww138']
1157,32241575,"Letter to the Editor re 'Volume of water added to crushed ice affects the efficacy of cryotherapy: a randomised, single-blind, crossover trial'.",,2020,,[],['cryotherapy'],[],[],"[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]",[],,0.0267955,,"[{'ForeName': 'Susan Y', 'Initials': 'SY', 'LastName': 'Kwiecien', 'Affiliation': 'Nicholas Institute of Sports Medicine and Athletic Trauma, Lenox Hill Hospital, New York, NY, USA; Department of Sport, Exercise & Rehabilitation, Northumbria University, Newcastle upon Tyne, UK. Electronic address: susan@nismat.org.'}]",Physiotherapy,['10.1016/j.physio.2020.02.007']
1158,32243613,Patient-reported outcome measures in multiple myeloma: Real-time reporting to improve care (My-PROMPT) - a pilot randomized controlled trial.,,2020,,[],[],['multiple myeloma: real-time reporting to improve care (My-PROMPT'],[],[],"[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.132905,,"[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Moore', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'King', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Erica M', 'Initials': 'EM', 'LastName': 'Wood', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rasa', 'Initials': 'R', 'LastName': 'Ruseckaite', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Klarica', 'Affiliation': 'Department of Malignant Haematology, The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Department of Malignant Haematology, The Alfred Hospital, Melbourne, Victoria, Australia.'}, {'ForeName': 'P Joy', 'Initials': 'PJ', 'LastName': 'Ho', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""University of Melbourne, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'H Miles', 'Initials': 'HM', 'LastName': 'Prince', 'Affiliation': 'Epworth Healthcare and University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Zoe K', 'Initials': 'ZK', 'LastName': 'McQuilten', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}]",American journal of hematology,['10.1002/ajh.25815']
1159,32493715,"Starch Digestion-Related Amylase Genetic Variants, Diet, and Changes in Adiposity: Analyses in Prospective Cohort Studies and a Randomized Dietary Intervention.","Salivary amylase, encoded by the  AMY1  gene, is responsible for the digestion of carbohydrates. We investigated associations of  AMY1  genetic variations with general and central adiposity changes considering dietary carbohydrate intake among 32,054 adults from four prospective cohort studies. A genetic risk score (GRS) was calculated based on nine  AMY1  single-nucleotide polymorphisms, with higher AMY1-GRS indicating higher activity of salivary amylase. We meta-analyzed interactions between AMY1-GRS and dietary intake for changes in general and central adiposity over 5.5-10 years. We found that carbohydrate food intake significantly altered associations of AMY1-GRS with changes in BMI ( P   interaction  = 0.001) and waist circumference ( P   interaction  < 0.001). Results were consistent and significant in female cohorts rather than in male cohorts. Among women, higher AMY1-GRS was associated with more increases in adiposity if dietary carbohydrate food intake was high, while higher AMY1-GRS was associated with less gains in adiposity when the dietary intake was low. Also, in a 2-year randomized dietary intervention trial, associations of AMY1-GRS with changes in weight ( P   interaction  = 0.023) and waist circumference ( P   interaction  = 0.037) were significantly modified by carbohydrate intake. Our results suggest the importance of precision nutrition strategies considering participants' genetic adaptation to carbohydrate-rich diets in regulating general and central adiposity.",2020,"Among women, higher AMY1-GRS was associated with more increases in adiposity if dietary carbohydrate food intake was high, while higher AMY1-GRS was associated with less gains in adiposity when the dietary intake was low.",['32054 adults from 4 prospective cohort studies'],[],"['genetic risk score (GRS', 'waist circumference', 'adiposity if dietary carbohydrate food intake', 'body mass index']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]",[],"[{'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012170', 'cui_str': 'Carbohydrates, Dietary'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",32054.0,0.0265795,"Among women, higher AMY1-GRS was associated with more increases in adiposity if dietary carbohydrate food intake was high, while higher AMY1-GRS was associated with less gains in adiposity when the dietary intake was low.","[{'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Heianza', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA nhyoh@channing.harvard.edu lqi1@tulane.edu luqi@hsph.harvard.edu.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yuhang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA.'}, {'ForeName': 'Walter C', 'Initials': 'WC', 'LastName': 'Willett', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA nhyoh@channing.harvard.edu lqi1@tulane.edu luqi@hsph.harvard.edu.'}]",Diabetes,['10.2337/db19-1257']
1160,32500298,Effects of high-frequency repetitive transcranial magnetic stimulation on reach-to-grasp performance in individuals with Parkinson's disease: a preliminary study.,"Individuals with Parkinson's disease (PD) have deficits in reach-to-grasp (RTG) execution and visuospatial processing which may be a result of dopamine deficiency in two brain regions: primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC). We hypothesized that improvement following M1 stimulation would be the result of a direct impact on motor execution; whereas, DLPFC stimulation would improve the role of DLPFC in visuospatial processing. The aim of pilot study was to investigate the effects of HF-rTMS on RTG performance by stimulating either M1 or DLPFC. Thirty individuals with PD participated (H&Y stages I-III). All of them were more affected on the right side. Participants were allocated into three groups. The DLPFC group received HF-rTMS over left DLPFC; while, the M1 group received HF-rTMS over left M1 of extensor digitorum communis representational area. The control group received HF-rTMS over the vertex. Before and immediately post HF-rTMS, right-hand RTG performance was measured under no barrier and barrier conditions. Additionally, TMS measures including motor-evoked-potential (MEP) amplitude and cortical silent period (CSP) were determined to verify the effects of HF-rTMS. For the results, there were no significant differences among the three groups. However, only the M1 group showed a significant decrease in movement time immediately after HF-rTMS for a barrier condition. Moreover, the M1 group showed a near-significant increase in hand opening and transport velocity. As for the DLPFC group, there was a near-significant increase in temporal transport-grasp coordination and a significant increase in velocity. Increased MEP amplitudes and a significantly longer CSP in the M1 and DLPFC groups confirmed the effects of HF-rTMS. Regarding non-significant results among the three groups, it is still inconclusive whether there were different effects of the rTMS on the two stimulation areas. This is a preliminary study demonstrating that HF-rTMS to M1 may improve RTG execution; whereas, HF-rTMS to DLPFC may improve visuospatial processing demands of RTG.",2020,Increased MEP amplitudes and a significantly longer CSP in the M1 and DLPFC groups confirmed the effects of HF-rTMS.,"[""Individuals with Parkinson's disease (PD"", ""individuals with Parkinson's disease"", 'Thirty individuals with PD participated (H&Y stages I-III']","['high-frequency repetitive transcranial magnetic stimulation', 'rTMS', 'HF-rTMS']","['TMS measures including motor-evoked-potential (MEP) amplitude and cortical silent period (CSP', 'Increased MEP amplitudes', 'movement time', 'hand opening and transport velocity', 'reach-to-grasp performance', 'RTG performance', 'temporal transport-grasp coordination', 'velocity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]",30.0,0.0137685,Increased MEP amplitudes and a significantly longer CSP in the M1 and DLPFC groups confirmed the effects of HF-rTMS.,"[{'ForeName': 'Jenjira', 'Initials': 'J', 'LastName': 'Thanakamchokchai', 'Affiliation': 'Motor Control and Neural Plasticity Laboratory, Faculty of Physical Therapy, Mahidol University, 999 Putthamonthon 4 Road, Salaya, 73170, Nakorn Pathom, Thailand.'}, {'ForeName': 'Jarugool', 'Initials': 'J', 'LastName': 'Tretriluxana', 'Affiliation': 'Motor Control and Neural Plasticity Laboratory, Faculty of Physical Therapy, Mahidol University, 999 Putthamonthon 4 Road, Salaya, 73170, Nakorn Pathom, Thailand. jarugool.tre@mahidol.ac.th.'}, {'ForeName': 'Narawut', 'Initials': 'N', 'LastName': 'Pakaprot', 'Affiliation': 'Department of Physiology, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road Bangkoknoi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Apichart', 'Initials': 'A', 'LastName': 'Pisarnpong', 'Affiliation': 'Movement Disorder Clinic, Division of Neurology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road Bangkoknoi, Bangkok, 10700, Thailand.'}, {'ForeName': 'Beth E', 'Initials': 'BE', 'LastName': 'Fisher', 'Affiliation': 'Division of Biokinesiology and Physical Therapy, Southern California University, 1540 Alcazar St., CHP 155, Los Angeles, CA, 90089-9006, USA.'}]",Experimental brain research,['10.1007/s00221-020-05843-6']
1161,32497491,"Tail-phase safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in HIV-uninfected adults: a secondary analysis of the HPTN 077 trial.","BACKGROUND


Long-acting injectable cabotegravir is a novel integrase inhibitor currently in advanced clinical development for HIV prevention and treatment. We aimed to assess the terminal phase pharmacokinetics and safety of long-acting injectable cabotegravir in participants included in the HPTN 077 trial.
METHODS


HPTN 077 was a multicentre, double-blind, randomised, placebo-controlled phase 2a trial done at eight sites in Brazil, Malawi, South Africa, and the USA. Participants (aged 18-65 years), who were HIV-uninfected and at low-risk for HIV, were randomly assigned (3:1) to long-acting injectable cabotegravir (800 mg given three times at 12 week intervals or 600 mg given five times, administered at one 4 week interval, and every 8 weeks thereafter) or placebo. Participants were followed up to 76 weeks after final injection. In a prespecified analysis of secondary and exploratory outcomes, we assessed the safety, measured by the proportion of participants with grade 2 or worse adverse events, and pharmacokinetics, measured by apparent terminal phase half-life (t 1/2app ) and estimated time to lower limit of quantification (LLOQ) of long-acting injectable cabotegravir during the injection phase (defined as the time between first injection and 12 weeks or 8 weeks after the last injection in cohort 1 or cohort 2 respectively) and tail phase (defined as the time between final injection and 52-76 weeks post-final injection). Safety was analysed in all participants who received at least one injection. Pharmacokinetic analyses included all participants who had received at least one injection and had at least three cabotegravir measurements higher than the LLOQ after the final injection. Pharmacokinetic outcomes were estimated using non-compartmental methods. The trial is completed, and was registered with ClinicalTrials.gov, NCT02178800.
FINDINGS


Between Feb 9, 2015, and May 27, 2016, 177 participants (134 participants in the cabotegravir group [74 participants in cohort 1; 60 participants in cohort 2] and 43 participants in the placebo group [25 participants in cohort 1; 18 participants in cohort 2) were enrolled and received at least one injection and thus were included in the safety analysis. The incidence of grade 2 or worse adverse events was significantly lower during the tail phase than the injection phase (p<0·0001). At 52-60 weeks after final injection, nine (23%) of 40 male participants had detectable cabotegravir concentrations and at week 76, four (13%) of 30 male participants had detectable cabotegravir concentrations compared with 52 (63%) of 82 female participants and 27 (42%) of 64 female participants at the same timepoints. The median time from the last injection to the time when cabotegravir concentration decreased below the LLOQ was 43·7 weeks (IQR 31·1-66·6; range 20·4-152·5) for male participants and 67·3 weeks (29·1-89·6; 17·7-225·5) for female participants (p=0·0003). t 1/2app  was longer for female participants than male participants (geometric mean fold-change 1·33, 95% CI 1·06-1·68; p=0·014), and longer for participants with a high body-mass index (BMI) than those with a low BMI (1·31, 1·06-1·63; p=0·015).
INTERPRETATION


The clinical significance of the long pharmacokinetic tail of cabotegravir observed in female participants compared with male participants, and those with higher BMI compared with a lower BMI, need to be addressed in future trials.
FUNDING


National Institute of Allergy and Infectious Diseases.",2020,The incidence of grade 2 or worse adverse events was significantly lower during the tail phase than the injection phase (p<0·0001).,"['Participants (aged 18-65 years), who were HIV-uninfected and at low-risk for HIV', 'participants who had received at least one injection and had at least three cabotegravir measurements higher than the LLOQ after the final injection', '82 female participants and 27 (42%) of 64 female participants at the same timepoints', 'HIV-uninfected adults', 'participants included in the HPTN 077 trial', 'Between Feb 9, 2015, and May 27, 2016, 177 participants (134 participants in the cabotegravir group [74 participants in cohort 1; 60 participants in cohort 2] and 43 participants in the placebo group [25 participants in cohort 1; 18 participants in cohort 2', 'female participants compared with male participants']","['long-acting injectable cabotegravir', 'placebo']","['Safety', 'Pharmacokinetic outcomes', 'median time', 'detectable cabotegravir concentrations', 'cabotegravir concentration', 'Tail-phase safety, tolerability, and pharmacokinetics', 'incidence of grade 2 or worse adverse events', 'proportion of participants with grade 2 or worse adverse events, and pharmacokinetics, measured by apparent terminal phase half-life (t 1/2app ) and estimated time to lower limit of quantification (LLOQ) of long-acting injectable cabotegravir']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}]",40.0,0.577418,The incidence of grade 2 or worse adverse events was significantly lower during the tail phase than the injection phase (p<0·0001).,"[{'ForeName': 'Raphael J', 'Initials': 'RJ', 'LastName': 'Landovitz', 'Affiliation': 'UCLA Center for Clinical AIDS Research and Education, Division of Infectious Diseases, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: rlandovitz@mednet.ucla.edu.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Eron', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Halima', 'Initials': 'H', 'LastName': 'Dawood', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Albert Y', 'Initials': 'AY', 'LastName': 'Liu', 'Affiliation': 'Bridge HIV, Population Health Division, San Francisco Department of Health, San Francisco, CA, USA.'}, {'ForeName': 'Manya', 'Initials': 'M', 'LastName': 'Magnus', 'Affiliation': 'Department of Epidemiology, Milken Institute School of Public Health at The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Ravindre', 'Initials': 'R', 'LastName': 'Panchia', 'Affiliation': 'Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Soweto, South Africa.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cottle', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Chau', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Eshleman', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Kofron', 'Affiliation': 'UCLA Center for Clinical AIDS Research and Education, Division of Infectious Diseases, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Adeola', 'Initials': 'A', 'LastName': 'Adeyeye', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burns', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Rinehart', 'Affiliation': 'ViiV Healthcare, Durham, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Margolis', 'Affiliation': 'ViiV Healthcare, Durham, NC, USA.'}, {'ForeName': 'Myron S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Marybeth', 'Initials': 'M', 'LastName': 'McCauley', 'Affiliation': 'FHI 360, Washington, DC, USA.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30106-5']
1162,32502969,Treatment of Childhood Obesity Based on Brazilian Dietary Guidelines Plus Energy Restriction (PAPPAS HUPE Study): Protocol for a Randomized Clinical Trial.,"BACKGROUND


The Food Guide for the Brazilian Population relies on natural or minimally processed foods mainly of plant origin such as beans and rice with low oil, salt, and sugar content and limited consumption of ultraprocessed foods. Reduction of ultraprocessed foods improves diet quality and energy consumption.
OBJECTIVE


The goal of this study is to evaluate the effectiveness of an intervention for the treatment of obesity in children, with counseling based on the Brazilian Food Guide plus control of total energy intake.
METHODS


A parallel, randomized clinical trial will include children aged 7 to 12 years. Randomization will be performed in blocks of 10 individuals using computer-generated random sequence numbers. Both the control and intervention groups will participate in 6 standardized educational activities based on the 10 steps of the Brazilian Food Guide. These activities will be conducted at the University Hospital Toy Library, located in the pediatric outpatient clinic. For the intervention group, in addition to the educational activities, an individualized food plan based on the nutritional recommendations of the Brazilian Society of Pediatrics will be prescribed and discussed with the mothers and fathers. The primary outcome of the study will be variations in body mass index, and secondary outcomes will include analysis of insulin resistance, blood pressure, body fat percentage, and waist and neck circumference.
RESULTS


This project was funded by the National Council for Scientific and Technological Development in December 2017 (grant no 408333/2017-0). Recruitment began in August 2018 and by September 2019, we had enrolled the 101 participants. In addition to the patients referred by the national system of regulation, recruitment was made by medical outpatient referral and external indication. This is an ongoing study. We expect the results to be published in November 2020.
CONCLUSIONS


At the end of the project, in case of a positive result, a protocol for the treatment of obesity based on the Brazilian Food Guide will be proposed to the Unified Health System. A successful method to reduce childhood obesity is expected.
TRIAL REGISTRATION


Brazilian Registry of Clinical Trials RBR-3st5sn; http://www.ensaiosclinicos.gov.br/rg/RBR-3st5sn.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/16170.",2020,Both the control and intervention groups will participate in 6 standardized educational activities based on the 10 steps of the Brazilian Food Guide.,"['10 individuals using computer-generated random sequence numbers', 'obesity in children, with counseling based on the Brazilian Food Guide plus control of total energy intake', 'Recruitment began in August 2018 and by September 2019, we had enrolled the 101 participants', 'children aged 7 to 12 years']",[],"['diet quality and energy consumption', 'body mass index, and secondary outcomes will include analysis of insulin resistance, blood pressure, body fat percentage, and waist and neck circumference', 'childhood obesity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}]",,0.0560747,Both the control and intervention groups will participate in 6 standardized educational activities based on the 10 steps of the Brazilian Food Guide.,"[{'ForeName': 'Joana Maia', 'Initials': 'JM', 'LastName': 'Brandao', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Rosely', 'Initials': 'R', 'LastName': 'Sichieri', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Simone Augusta', 'Initials': 'SA', 'LastName': 'Ribas', 'Affiliation': 'Department of Nutrition and Public Health, School of Nutrition, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Eliseu', 'Initials': 'E', 'LastName': 'Verly-Jr', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Rosangela Alves', 'Initials': 'RA', 'LastName': 'Pereira', 'Affiliation': 'Department of Social and Applied Nutrition, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Inês Rugani Ribeiro De', 'Initials': 'IRR', 'LastName': 'Castro', 'Affiliation': 'Department of Social Nutrition, Nutrition Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Bruna Kulik', 'Initials': 'BK', 'LastName': 'Hassan', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alessandra Silva Dias De', 'Initials': 'ASD', 'LastName': 'Oliveira', 'Affiliation': 'Department of Social Nutrition, Nutrition Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Emanuele Souza', 'Initials': 'ES', 'LastName': 'Marques', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Diana Barbosa', 'Initials': 'DB', 'LastName': 'Cunha', 'Affiliation': 'Department of Epidemiology, Social Medicine Institute, State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}]",JMIR research protocols,['10.2196/16170']
1163,32506368,Impact of neurosurgical enhanced recovery after surgery (ERAS) program on health-related quality of life in glioma patients: a secondary analysis of a randomized controlled trial.,"INTRODUCTION


A novel neurosurgical enhanced recovery after surgery (ERAS) program shortens postoperative hospital stay and accelerates functional recovery in elective craniotomy patients. There is a need to evaluate the impact of ERAS program on patients' health-related quality of life (HRQOL).
METHODS


In a single-center randomized controlled trial, patients were randomized 1:1 to receive perioperative ERAS or conventional care. As a secondary outcome, HRQOL was measured with the EORTC QLQ-C30/BN20 prior to randomization (baseline), at discharge, and at 3- and 6-month follow-up.
RESULTS


A total of 65 patients (ERAS: n = 36, conventional care: n = 29) with pathologically confirmed glioma (WHO grade 2-4) were included in the analysis. Progression-free survival at 6 months and HRQOL at baseline were similar between the two groups. Changes of scores did not vary significantly over time, but differed significantly between intervention groups. A clinically relevant better QoL (at 3-month follow-up), physical functioning (at 6-month follow-up) and role functioning (at discharge) was observed in patients in the ERAS group. Symptom scores of constipation (at discharge), motor dysfunction (at discharge, 3- and 6-month follow-up), drowsiness (at 3- and 6-month follow-up), weakness of legs (at 3-month follow-up), and nausea/vomiting (at discharge and 6-month follow-up) were significantly lower in the ERAS group.
CONCLUSIONS


The neurosurgical ERAS program seems to improve functioning and symptoms scores in glioma patients within 6-month follow-up compared with conventional care. The intervention has a significant main effect HRQOL changes without significant interaction with time. Future well-powered multicenter studies are warranted to confirm this result and address long-term benefits. This study has been registered in the Chinese Clinical Trial Registry ( http://www.chictr.org.cn/showproj.aspx?proj=16480 ) with registration number ChiCTR-INR-16009662.",2020,The neurosurgical ERAS program seems to improve functioning and symptoms scores in glioma patients within 6-month follow-up compared with conventional care.,"['conventional care: n\u2009=\u200929) with pathologically confirmed glioma (WHO grade 2-4', 'elective craniotomy patients', '65 patients (ERAS: n\u2009=\u200936', 'glioma patients']","['perioperative ERAS or conventional care', 'neurosurgical enhanced recovery after surgery (ERAS) program', 'surgery (ERAS) program', 'ERAS program']","['HRQOL', 'functioning and symptoms scores', 'health-related quality of life', 'weakness of legs', 'physical functioning', 'nausea/vomiting', 'postoperative hospital stay', 'Symptom scores of constipation (at discharge), motor dysfunction (at discharge, 3- and 6-month follow-up), drowsiness', 'Progression-free survival']","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0427068', 'cui_str': 'Monoparesis - leg'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",65.0,0.095925,The neurosurgical ERAS program seems to improve functioning and symptoms scores in glioma patients within 6-month follow-up compared with conventional care.,"[{'ForeName': 'Bolin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, No. 777 Xitai Road, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Shujuan', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics and Gynecology, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lu', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, No. 777 Xitai Road, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, No. 777 Xitai Road, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, No. 777 Xitai Road, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Ma', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, No. 777 Xitai Road, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Yufu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Guodong', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Qu', 'Affiliation': ""Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Shiming', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ""Department of Neurosurgery, Xi'an International Medical Center, No. 777 Xitai Road, Xi'an, Shaanxi Province, China. he-shiming@163.com.""}]",Journal of neuro-oncology,['10.1007/s11060-020-03548-y']
1164,32506371,Repeat radiation with bevacizumab and minocycline in bevacizumab-refractory high grade gliomas: a prospective phase 1 trial.,"INTRODUCTION


There are no effective treatments for gliomas after progression on radiation, temozolomide, and bevacizumab. Microglia activation may be involved in radiation resistance and can be inhibited by the brain penetrating antibiotic minocycline. In this phase 1 trial, we examined the safety and effect on survival, symptom burden, and neurocognitive function of reirradiation, minocycline, and bevacizumab.
METHODS


The trial used a 3 + 3 design for dose escalation followed by a ten person dose expansion. Patients received reirradiation with dosing based on radiation oncologist judgment, bevacizumab 10 mg/kg IV every two weeks, and oral minocycline twice a day. Symptom burden was measured using MDASI-BT. Neurocognitive function was measured using the COGSTATE battery.
RESULTS


The maximum tolerated dose of minocycline was 400 mg twice a day with no unexpected toxicities. The PFS3 was 64.6%, and median overall survival was 6.4 months. Symptom burden and neurocognitive function did not decline in the interval between treatment completion and tumor progression.
CONCLUSIONS


Minocycline 400 mg orally twice a day with bevacizumab and reirradiation is well tolerated by physician and patient reported outcomes in people with gliomas that progress on bevacizumab.",2020,"Symptom burden and neurocognitive function did not decline in the interval between treatment completion and tumor progression.
",['refractory high grade gliomas'],"['temozolomide, and bevacizumab', 'bevacizumab', 'Minocycline 400\xa0mg orally twice a day with bevacizumab and reirradiation', 'minocycline', 'bevacizumab and minocycline']","['toxicities', 'median overall survival', 'Neurocognitive function', 'Symptom burden', 'Symptom burden and neurocognitive function', 'survival, symptom burden, and neurocognitive function of reirradiation, minocycline, and bevacizumab']","[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4042794', 'cui_str': 'Re Irradiation'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4042794', 'cui_str': 'Re Irradiation'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]",,0.0873686,"Symptom burden and neurocognitive function did not decline in the interval between treatment completion and tumor progression.
","[{'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Cohen', 'Affiliation': 'Division of Medical Oncology, University of Utah School of Medicine, Salt Lake City, UT, USA. Adam.cohen@hci.utah.edu.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Anker', 'Affiliation': 'Division of Radiation Oncology, University of Vermont Larner College of Medicine, Burlington, VT, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Johnson', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Burt', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Dennis C', 'Initials': 'DC', 'LastName': 'Shrieve', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Salzman', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Jensen', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Boucher', 'Affiliation': 'Division of Medical Oncology, University of Utah School of Medicine, Salt Lake City, UT, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Colman', 'Affiliation': 'Huntsman Cancer Institute, Salt Lake City, UT, USA.'}]",Journal of neuro-oncology,['10.1007/s11060-020-03551-3']
1165,32508318,Eight-gene signature predicts recurrence in lung adenocarcinoma.,"BACKGROUND


Recurrence significantly influences the survival in patients with lung adenocarcinoma (LUAD). However, there are less gene signatures that predict recurrence risk of LUAD.
OBJECTIVE


We performed this study to construct a model to predict risk of recurrence in LUAD.
METHODS


RNA-seq data from 426 patients with LUAD were downloaded from The Cancer Genome Atlas (TCGA) and were randomly assigned into the training (n= 213) and validation set (n= 213). Differentially expressed genes (DEGs) between recurrent and non-recurrent tumors in the training set were identified. Recurrence-associated DEGs were selected using multivariate Cox regression analysis. The recurrence risk model that identifies patients at low and high risk for recurrence was constructed, followed by the validation of its performance in the validation set and a microarray dataset.
RESULTS


In total, 378 DEGs, including 20 recurrence-associated DEGs, were identified between the recurrent and non-recurrent tumors in the training set. The signatures of 8 genes (including AZGP1, INPP5J, MYBPH, SPIB, GUCA2A, HTR1B, SLC15A1 and TNFSF11) were used to construct the prognostic model to assess the risk of recurrence. This model indicated that patients with high risk scores had shorter recurrence-free survival time compared with patients with low risk scores. ROC curve analysis of this model showed it had high predictive accuracy (AUC > 0.8) to predict LUAD recurrence in the TCGA cohort (the training and validation sets) and GSE50081 dataset. This prognostic model showed high predictive power and performance in predicting recurrence in LUAD.
CONCLUSION


We concluded that this model might be of great value for evaluating the risk of recurrence of LUAD in clinics.",2020,This model indicated that patients with high risk scores had shorter recurrence-free survival time compared with patients with low risk scores.,"['lung patients with adenocarcinoma (LUAD', '426 patients with LUAD were downloaded from The Cancer Genome Atlas (TCGA', 'lung adenocarcinoma']",[],"['20 recurrence-associated DEGs', 'recurrence-free survival time', 'LUAD recurrence']","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}]",[],"[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C2919551', 'cui_str': 'Duration of recurrence-free survival'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}]",426.0,0.0320685,This model indicated that patients with high risk scores had shorter recurrence-free survival time compared with patients with low risk scores.,"[{'ForeName': 'Yongjian', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiothoracic Surgery, The Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Fan', 'Affiliation': 'Department of Oncology Radiology, The Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiothoracic Surgery, The Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.'}, {'ForeName': 'Koujun', 'Initials': 'K', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiothoracic Surgery, The Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China.'}]",Cancer biomarkers : section A of Disease markers,['10.3233/CBM-190329']
1166,32513043,Assessing school-lunch feeding and nutrition education strategy for healthier kids in selected Philippine public schools.,"BACKGROUND


Nutrition interventions during the early years of a child's life are anchored on the need to provide good nutrition and proper health care to optimize their growth potential as adults. In the Philippines, undernutrition is a persistent problem among 0-10 year old Filipino children. In this age group, children consume a diet poor in quantity and quality.
AIM


This study aimed to assess the effects of a school-lunch and nutrition education intervention among schoolchildren in terms of attaining good nutrition.
METHOD


Using a quasi-experimental design, children aged 7-9 years from public elementary schools in the province of Laguna, Philippines were categorized into three intervention groups and one non-intervention group. Anthropometric measurements; nutrition knowledge, attitude and behavior; and food intake among children and households were collected at baseline and endline periods. SPSS for Windows version 16 and Stata version 15 were utilized for data analysis.
RESULTS


Mean scores on knowledge, attitude and behavior of schoolchildren in intervention groups increased significantly at endline ( p <0.05). Protein requirement was met by more children and households than the energy requirement. Most children with normal nutritional status after the interventions (25.3%) belonged to the group with the complete intervention of school-lunch and nutrition education.
CONCLUSIONS


The provision of both school-lunch feeding and nutrition education is effective in improving the knowledge, attitude and behavior scores and nutritional status of schoolchildren. The adoption and institutionalization of complete intervention with school-lunch and nutrition education in elementary public schools should be pursued.",2020,"Mean scores on knowledge, attitude and behavior of schoolchildren in intervention groups increased significantly at endline ( p <0.05).","['elementary public schools', 'children aged 7-9 years from public elementary schools in the province of Laguna, Philippines', 'children and households', 'healthier kids in selected Philippine public schools', '0-10 year old Filipino children']","['school-lunch and nutrition education intervention', 'school-lunch and nutrition education']","['Anthropometric measurements; nutrition knowledge, attitude and behavior; and food intake', 'Mean scores on knowledge, attitude and behavior of schoolchildren', 'knowledge, attitude and behavior scores and nutritional status of schoolchildren']","[{'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1556093', 'cui_str': 'Filipinos'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}]",,0.0149952,"Mean scores on knowledge, attitude and behavior of schoolchildren in intervention groups increased significantly at endline ( p <0.05).","[{'ForeName': 'Julieta B', 'Initials': 'JB', 'LastName': 'Dorado', 'Affiliation': 'Department of Science and Technology, Food and Nutrition Research Institute, Philippines.'}, {'ForeName': 'Glenda P', 'Initials': 'GP', 'LastName': 'Azaña', 'Affiliation': 'Department of Science and Technology, Food and Nutrition Research Institute, Philippines.'}, {'ForeName': 'Rowena V', 'Initials': 'RV', 'LastName': 'Viajar', 'Affiliation': 'Department of Science and Technology, Food and Nutrition Research Institute, Philippines.'}, {'ForeName': 'Ma Anna Rita M', 'Initials': 'MARM', 'LastName': 'Ramirez', 'Affiliation': 'Department of Science and Technology, Food and Nutrition Research Institute, Philippines.'}, {'ForeName': 'Eldridge B', 'Initials': 'EB', 'LastName': 'Ferrer', 'Affiliation': 'Department of Science and Technology, Food and Nutrition Research Institute, Philippines.'}, {'ForeName': 'Nesrianne G', 'Initials': 'NG', 'LastName': 'Buyco', 'Affiliation': 'Department of Science and Technology, Food and Nutrition Research Institute, Philippines.'}, {'ForeName': 'Divorah V', 'Initials': 'DV', 'LastName': 'Aguila', 'Affiliation': 'Department of Science and Technology, Food and Nutrition Research Institute, Philippines.'}, {'ForeName': 'Mario V', 'Initials': 'MV', 'LastName': 'Capanzana', 'Affiliation': 'Department of Science and Technology, Food and Nutrition Research Institute, Philippines.'}]",Nutrition and health,['10.1177/0260106020930466']
1167,32513881,"Evaluation of the For Our Children's Sake intervention, parental support in prison to influence positive parenting: study protocol for a controlled trial.","INTRODUCTION


Children of incarcerated parents comprise a greatly disadvantaged group in society and positive parenting constitutes an important factor for children's healthy development. Internationally developed parenting interventions for incarcerated parents suggest an impact on parenting outcomes, but no such evaluation has been undertaken in Sweden.This study aims to investigate the effects of the parenting programme currently offered in prisons in Sweden, For Our Children's Sake (FOCS), through a controlled trial with a parallel implementation process evaluation.
METHODS AND ANALYSIS


The effectiveness trial is carried out as a non-blinded controlled trial with a parallel investigation of the implementation process using mixed methods. Participants comprise incarcerated parents (men and women) in Swedish prisons with a target sample size of 76 parents. Eligible parents have a child aged 0 to 18 years, no prohibition to contact or committed a crime against the child, or a violent crime against the other parent. The FOCS intervention is carried out in group format over 10 weeks. The primary outcome is closeness in parent-child relationship measured with the Child Parent Relationship Scale. Secondary outcomes comprise parent-child contact, parental criminal attitude and interest in other treatment programmes. Mediators comprise attitude to parenting, and self-efficacy. Outcome data are self-reported and collected over four time points: baseline (September to December 2019), mid and after intervention, and at 3 months follow-up. Implementation data is collected during and after intervention. Intervention fidelity is monitored through audio recordings, dose is registered per participant, reach comprise included versus eligible number of parents and acceptability is investigated through semi-structured interviews. Factors influencing implementation will be investigated using a questionnaire.
ETHICS AND DISSEMINATION


Ethical permission has been obtained by the Swedish Ethical Review Authority 2019-04227. Findings will be published in peer-reviewed journals, presented at scientific conferences and presented to participants in writing.
TRIAL REGISTRATION NUMBER


NCT04101799; Pre-results.",2020,"Internationally developed parenting interventions for incarcerated parents suggest an impact on parenting outcomes, but no such evaluation has been undertaken in Sweden.","[""prisons in Sweden, For Our Children's Sake (FOCS"", 'Participants comprise incarcerated parents (men and women) in Swedish prisons with a target sample size of 76 parents', 'Eligible parents have a child aged 0 to 18 years, no prohibition to contact or committed a crime against the child, or a violent crime against the other parent', ""children's healthy development""]","['FOCS intervention', 'parenting programme']","['parent-child contact, parental criminal attitude and interest in other treatment programmes', 'closeness in parent-child relationship measured with the Child Parent Relationship Scale']","[{'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0010325', 'cui_str': 'Crime'}, {'cui': 'C0242151', 'cui_str': 'Violent'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.235758,"Internationally developed parenting interventions for incarcerated parents suggest an impact on parenting outcomes, but no such evaluation has been undertaken in Sweden.","[{'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Norman', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Stockholm County, Sweden asa.norman@ki.se.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Enebrink', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Stockholm County, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-034834']
1168,32513895,Does delaying discharge from intensive care until after tracheostomy removal affect 30-day mortality? Propensity score matched cohort study.,"OBJECTIVE


To investigate the short-term mortality effect of discharge from an intensive care unit (ICU) with a tracheostomy in place in comparison to delaying discharge until after tracheostomy removal.
DESIGN


A propensity score matched cohort study using data from the TracMan study.
SETTING


Seventy-two UK ICUs taking part in the TracMan study, a randomised controlled trial comparing early tracheostomy (within 4 days of critical care admission) with deferred tracheostomy (after 10 days if still indicated).
PARTICIPANTS


622 patients who underwent a tracheostomy while in the TracMan study between November 2004 and November 2008. 144 patients left ICU with a tracheostomy. 999 days of observation from 294 patients were included in the control pool.
INTERVENTIONS


We matched patients discharged with a tracheostomy in place 1:1 with patients who remained in an ICU until either their tracheostomy was removed or they died with the tracheostomy in place. Propensity models were developed according to discharge destination, accounting for likely confounding factors.
PRIMARY OUTCOME MEASURE


The primary outcome was 30-day mortality from the matching day. For the 'discharged with a tracheostomy' group, this was death within 30 days after the discharge day. For the 'remained in ICU' group, this was death within 30 days after the matched day.
RESULTS


22 (15.3%) patients who left ICU with a tracheostomy died within 30 days compared with 26 (18.1%) who remained in ICU (relative risk 0.98, 95% CI 0.43 to 2.23).
CONCLUSION


Keeping patients on an ICU to provide tracheostomy care was not found to affect mortality. Tracheostomy presence may indicate a higher risk of mortality due to underlying diseases and conditions rather than posing a risk in itself.The TracMan trial was registered on the ISRCTN database (ISRCTN28588190).",2020,"RESULTS


22 (15.3%) patients who left ICU with a tracheostomy died within 30 days compared with 26 (18.1%) who remained in ICU (relative risk 0.98, 95% CI 0.43 to 2.23).
","['Seventy-two UK ICUs taking part in the TracMan study, a randomised controlled trial comparing early tracheostomy (within 4 days of critical care admission) with deferred tracheostomy (after 10 days if still indicated', 'matched patients discharged with a tracheostomy in place 1:1 with patients who remained in an ICU until either their tracheostomy was removed or they died with the tracheostomy in place', '294 patients were included in the control pool', '622 patients who underwent a tracheostomy while in the TracMan study between November 2004 and November 2008', '144 patients left ICU with a tracheostomy']",['intensive care unit (ICU'],['30-day mortality'],"[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205091', 'cui_str': 'Left'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",294.0,0.23793,"RESULTS


22 (15.3%) patients who left ICU with a tracheostomy died within 30 days compared with 26 (18.1%) who remained in ICU (relative risk 0.98, 95% CI 0.43 to 2.23).
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Vollam', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, Oxon, UK sarah.vollam@ndcn.ox.ac.uk.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'J Duncan', 'Initials': 'JD', 'LastName': 'Young', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, Oxon, UK.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Watkinson', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Oxford University, Oxford, Oxon, UK.'}]",BMJ open,['10.1136/bmjopen-2020-037762']
1169,32520721,"Interleukin-2 drives cortisol secretion in an age-, dose-, and body composition-dependent way.","Background


Interleukin-2 (IL-2), one of the proinflammatory cytokines, is used in the treatment of certain malignancies. In some studies, transient increases in cortisol and ACTH secretion occurred. Thus, this agent may be used as an experimental probe of adrenal cortisol secretion.
Objective


This study quantifies the effects of low and moderate doses of IL-2 on cortisol secretion and assesses the modulation by age, dose and body composition.
Site


Mayo Clinical Translational Research Unit.
Subjects


Study comprised 35 healthy men, 17 young and 18 older.
Methods


Randomized prospective double-blind saline-controlled study of IL-2 administration in two doses with concurrent 10-min blood sampling for 24 h.
Outcome measures


Deconvolution analysis and approximate entropy of cortisol secretion.
Results


Low-dose IL-2 administration increased nocturnal pulsatile cortisol secretion from 1460 ± 160 to 2120 ± 220 nmol/L/8 h in young subjects and from 1680 ± 105 to 1960 ± 125 nmol/L/8 h (treatment P < 0.0001, but more in young than older, P = 0.02). Comparable results were obtained for total cortisol secretion (P treatment <0.0001, age effect P = 0.005). The higher IL-2 dose caused a large increase in young (P < 0.0001), but not in older (P = 0.90) subjects. This dose also increased approximate entropy from 0.877 ± 0.041 to 1.024 ± 0.049 (P = 0.008), pointing to reduced secretory orderliness. Incremental cortisol (nocturnal) secretion correlated negatively with visceral fat mass (R = -0.41, P = 0.019).
Conclusion


In healthy men, IL-2 injection drives pulsatile cortisol secretion in a dose-dependent way in young, but not older, individuals and erodes cortisol secretory orderliness at a higher dose in young subjects. Cortisol responses are diminished with increasing abdominal visceral fat mass.",2020,"The higher IL2 dose caused a large increase in young (P<0.0001), but not in older (P=0.90) subjects.","['35 healthy men, 17 young and 18 older', 'healthy men', 'Site']","['IL-2', 'IL-2 injection']","['Cortisol responses', 'nocturnal pulsatile cortisol secretion', 'Incremental cortisol (nocturnal) secretion', 'Deconvolution analysis and Approximate Entropy of cortisol secretion', 'visceral fat mass', 'total cortisol secretion', 'cortisol and ACTH secretion', 'Interleukin-2 drives cortisol secretion']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439606', 'cui_str': 'Pulsatile'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0004379', 'cui_str': 'Driving'}]",35.0,0.0249157,"The higher IL2 dose caused a large increase in young (P<0.0001), but not in older (P=0.90) subjects.","[{'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Roelfsema', 'Affiliation': 'Department of Internal Medicine, Section Endocrinology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, David Geffen School of Medicine at UCLA, Harbor-UCLA Medical Center and Los Angeles Biomedical Research Institute, Los Angeles, California, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Endocrine Research Unit, Mayo Clinic College of Medicine, Center for Translational Science Activities, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Takahashi', 'Affiliation': 'Primary Care Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Johannes D', 'Initials': 'JD', 'LastName': 'Veldhuis', 'Affiliation': 'Endocrine Research Unit, Mayo Clinic College of Medicine, Center for Translational Science Activities, Mayo Clinic, Rochester, Minnesota, USA.'}]",Endocrine connections,['10.1530/EC-20-0211']
1170,32520828,Autoimmune Hepatitis in Children: Prednisone Plus Azathioprine Versus Cyclosporine: A Randomized Trial.,"OBJECTIVE


The aim of this study was to find the outcome and adverse effects of 2 initial treatments in children with autoimmune hepatitis, prednisone (PRED) plus azathioprine (AZA) versus cyclosporine (CsA).
STUDY DESIGN


Between December 2008 and February 2012, 50 consecutive patients were centrally randomized to 1 of 2 treatment arms. Group 1: PRED was indicated at a dose of 1 to 2 mg · kg · day (up to 60 mg/day) and AZA at a dose of 1 to 2 mg · kg · day. Group 2: CsA was administered at a dose of 4 mg · kg · day orally divided into 2 doses. After remission, all patients were given a combination of PRED at 0.3 to 0.5 mg · kg · day and AZA at 1 to 2 mg · kg · day. Children presenting liver failure were placed on a triple immunosuppressive regimen if this condition persisted after 1 week of treatment, after liver function normalization they were switched back to their initial scheme.
RESULTS


A total of 26 patients received PRED-AZA and 24 CsA. Both treatments showed similar initial results in effectiveness and safety, although remission was achieved earlier with PRED-AZA: 8.6 versus CsA: 13.6 weeks (P < 0.0081). All children recovered liver function in a mean time of 32 ± 26 days. Cushingoid syndrome was more frequently observed with PRED-AZA (P < 0.001) and gingival hypertrophy with CsA (P < 0.001). A significant increase in body mass index was observed in all patients from initial treatment to remission, being greater with PRED-AZA.
CONCLUSIONS


Similar outcomes were obtained with PRED plus AZA or CsA treatments. Either therapeutic strategy could be used according to the particular characteristics of each patient. Triple immunosuppression was beneficial in patients with liver failure at onset.",2020,"RESULTS


26 patients received PRED-AZA and 24 CsA. Both treatments showed similar initial results in effectiveness and safety, although remission was achieved earlier with PRED-AZA: 8.6 vs CsA: 13.6 weeks (p < 0.0081).","['Children presenting liver failure (LF', '50 consecutive patients', 'Autoimmune Hepatitis in Children', 'patients with liver failure at onset', 'Between 12/2008-2/2012', 'children with autoimmune hepatitis (AIH']","['prednisone (PRED) plus azathioprine (AZA) vs cyclosporine (CsA', 'Cyclosporine', 'Triple immunosuppression', 'AZA', 'Prednisone Plus Azathioprine', 'CsA']","['Cushingoid syndrome', 'effectiveness and safety', 'PRED', 'gingival hypertrophy with CsA', 'liver function', 'body mass index (BMI']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0085605', 'cui_str': 'Hepatic failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241910', 'cui_str': 'Chronic autoimmune hepatitis'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0332601', 'cui_str': 'Cushingoid facies'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0017567', 'cui_str': 'Hypertrophy of gingiva'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",50.0,0.0972557,"RESULTS


26 patients received PRED-AZA and 24 CsA. Both treatments showed similar initial results in effectiveness and safety, although remission was achieved earlier with PRED-AZA: 8.6 vs CsA: 13.6 weeks (p < 0.0081).","[{'ForeName': 'Miriam L', 'Initials': 'ML', 'LastName': 'Cuarterolo', 'Affiliation': 'Hepatology Unit, Gastroenterology Department.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Ciocca', 'Affiliation': 'Hepatology Unit, Gastroenterology Department.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'López', 'Affiliation': 'Hepatology Unit, Gastroenterology Department.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Araujo', 'Affiliation': 'Nutrition Department, Hospital de Pediatría Prof. Dr. Juan P. Garrahan, Buenos Aires, Argentina.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Álvarez', 'Affiliation': 'Department of Pediatrics, CHU-Sainte Justine, University of Montreal, Montreal, Canada.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002776']
1171,32526771,Criteria for the determination of maximal oxygen uptake in patients newly diagnosed with cancer: Baseline data from the randomized controlled trial of physical training and cancer (Phys-Can).,"INTRODUCTION


Maximal oxygen uptake ([Formula: see text]) is a measure of cardiorespiratory fitness often used to monitor changes in fitness during and after treatment in cancer patients. There is, however, limited knowledge in how criteria verifying [Formula: see text] work for patients newly diagnosed with cancer. Therefore, the aim of this study was to describe the prevalence of fulfillment of typical criteria verifying [Formula: see text] and to investigate the associations between the criteria and the test leader's evaluation whether a test was performed ""to exhaustion"". An additional aim was to establish new cut-points within the associated criteria.
METHODS


From the Phys-Can randomized controlled trial, 535 patients (59 ±12 years) newly diagnosed with breast (79%), prostate (17%) or colorectal cancer (4%) performed an incremental [Formula: see text] test on a treadmill. The test was performed before starting (neo-)adjuvant treatment and an exercise intervention. Fulfillment of different cut-points within typical criteria verifying [Formula: see text] was described. The dependent key variables included in the initial bivariate analysis were achievement of a [Formula: see text] plateau, peak values for maximal heart rate, respiratory exchange ratio (RER), the patients' rating of perceived exertion on Borg's scale6-20 and peak breathing frequency (fR). A receiver operating characteristic analysis was performed to establish cut-points for variables associated with the test leader's evaluation. Last, a cross-validation of the cut-points found in the receiver operating characteristic analysis was performed on a comparable sample of cancer patients (n = 80).
RESULTS


The criteria RERpeak (<0.001), Borg's RPE (<0.001) and fR peak (p = 0.018) were associated with the test leader's evaluation of whether a test was defined as ""to exhaustion"". The cut-points that best predicted the test leader's evaluation were RER ≥ 1.14, RPE ≥ 18 and fR ≥ 40. Maximal heart rate and [Formula: see text] plateau was not associated with the test leader's evaluation.
CONCLUSION


We recommend a focus on RER (in the range between ≥1.1 and ≥1.15) and RPE (≥17 or ≥18) in addition to the test leader's evaluation. Additionally, a fR peak of ≥40 breaths/min may be a cut-point to help the test leader evaluate the degree of exhaustion. However, more research is needed to verify our findings, and to investigate how these criteria will work within a population that are undergoing or finished with cancer treatment.",2020,"The criteria RERpeak (<0.001), Borg's RPE (<0.001) and fR peak (p = 0.018) were associated with the test leader's evaluation of whether a test was defined as ""to exhaustion"".","['535 patients (59 ±12 years) newly diagnosed with breast (79%), prostate (17%) or colorectal cancer (4%) performed an', 'cancer patients', 'patients newly diagnosed with cancer']","['incremental [Formula: see text] test on a treadmill', 'physical training and cancer (Phys-Can']","[""achievement of a [Formula: see text] plateau, peak values for maximal heart rate, respiratory exchange ratio (RER), the patients' rating of perceived exertion on Borg's scale6-20 and peak breathing frequency (fR"", 'fR peak', 'Maximal heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",535.0,0.0740939,"The criteria RERpeak (<0.001), Borg's RPE (<0.001) and fR peak (p = 0.018) were associated with the test leader's evaluation of whether a test was defined as ""to exhaustion"".","[{'ForeName': 'Ann Christin Helgesen', 'Initials': 'ACH', 'LastName': 'Bjørke', 'Affiliation': 'Department of Sport Science and Physical Education, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': 'Department of Sport Science and Physical Education, University of Agder, Kristiansand, Norway.'}, {'ForeName': 'Sveinung', 'Initials': 'S', 'LastName': 'Berntsen', 'Affiliation': 'Department of Sport Science and Physical Education, University of Agder, Kristiansand, Norway.'}]",PloS one,['10.1371/journal.pone.0234507']
1172,32536587,Effect of Pretreatment and Activation Mode on the Interfacial Adaptation of Nanoceramic Resin Inlay and Self-adhesive Resin Cement.,"OBJECTIVES


The first objective of this study was to determine if the luting material used for resin nanoceramic inlay affects interfacial adaptation. The second was to investigate whether pretreatment and the adhesive curing method before cementation affects interfacial adaptation. The final objective was to compare activation modes of luting material.
METHODS


Class I cavities were prepared on extracted human third molars. Resin nanoceramic inlays were fabricated using Lava Ultimate CAD/CAM block (3 M). For the control groups, inlays were cemented using Panavia V5 (Kuraray Noritake). For the experimental groups, teeth were randomly divided into five experimental groups with four subgroups using different self-adhesive cements (SACs). Cement in Group I was dual-cured without pretreatment. In Group II, the cement was dual-cured after polyacrylic acid treatment of the tooth cavity. In Groups III and IV, the cement was dual-cured after universal dentin adhesive treatment with pre-cure and co-cure methods. In Group V, the inlay was cemented in self-cure mode. After thermocycling, interfacial adaptation at the inlay-tooth interface was measured using swept-source optical coherence tomography (SS-OCT) imaging. Finally, polymerization shrinkage strain of the luting material was measured and compared.
RESULTS


Interfacial adaptation differed depending on the luting material. After application of a universal adhesive, some subgroups showed improved interfacial adaptation. Interfacial adaptation and polymerization shrinkage strain differed significantly depending on activation mode.
SIGNIFICANCE


Interfacial adaptation for a resin nanoceramic inlay can differ according to the type of SAC and activation mode. For some SACs, application of a universal adhesive before cementation improves interfacial adaptation.",2020,"Interfacial adaptation and polymerization shrinkage strain differed significantly depending on activation mode.
","['Class', 'Nanoceramic Resin Inlay and Self-adhesive Resin Cement']",['self-adhesive cements (SACs'],"['interfacial adaptation', 'Interfacial adaptation and polymerization shrinkage strain']","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0376523', 'cui_str': 'Resin Cement'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0382302', 'cui_str': 'Adhesive cement'}]","[{'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0314672', 'cui_str': 'Polymerization'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]",,0.0172676,"Interfacial adaptation and polymerization shrinkage strain differed significantly depending on activation mode.
","[{'ForeName': 'Seung-Hoon', 'Initials': 'SH', 'LastName': 'Han', 'Affiliation': 'Department of Conservative Dentistry, St. Vincent Hospital, College of Medicine, The Catholic University of Korea, 93 Jungbu-daero, Paldal-gu, Suwon, Gyeonggi-do, South Korea. Electronic address: han7537@hotmail.com.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Shimada', 'Affiliation': 'Department of Operative Dentistry, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan; Department of Cariology and Operative Dentistry, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-0034 Japan. Electronic address: shimada.ope@okayama-u.ac.jp.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Sadr', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of Washington, 1959 NE Pacific St, B162, Seattle, WA, 98195 USA. Electronic address: arsadr@uw.edu.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tagami', 'Affiliation': 'Department of Cariology and Operative Dentistry, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-0034 Japan. Electronic address: tagami.ope@tmd.ac.jp.'}, {'ForeName': 'Kee-Yeon', 'Initials': 'KY', 'LastName': 'Kum', 'Affiliation': 'Department of Conservative Dentistry, Dental Research Institute, National Dental Care Center for Persons with Special Needs, Seoul National University Dental Hospital, Seoul National University School of Dentistry, 101 Daehak-ro, Jongno-gu, Seoul, 08030, Republic of Korea. Electronic address: kum6139@snu.ac.kr.'}, {'ForeName': 'Sung-Ho', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Conservative Dentistry, Oral Science Research Center, College of Dentistry, Yonsei University, #50 Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea. Electronic address: sunghopark@yuhs.ac.'}]",Dental materials : official publication of the Academy of Dental Materials,['10.1016/j.dental.2020.05.005']
1173,32546477,Paramedic experiences of using an enhanced stroke assessment during a cluster randomised trial: a qualitative thematic analysis.,"BACKGROUND


Intravenous thrombolysis is a key element of emergency treatment for acute ischaemic stroke, but hospital service delivery is variable. The Paramedic Acute Stroke Treatment Assessment (PASTA) multicentre cluster randomised controlled trial evaluated whether an enhanced paramedic-initiated stroke assessment pathway could improve thrombolysis volume. This paper reports the findings of a parallel process evaluation which explored intervention paramedics' experience of delivering the enhanced assessment.
METHODS


Interviewees were recruited from 453 trained intervention paramedics across three UK ambulance services hosting the trial: North East, North West and Welsh Ambulance Services. A semistructured interview guide aimed to (1) explore the stroke-specific assessment and handover procedures which were part of the PASTA pathway and (2) enable paramedics to share relevant views about expanding their role and any barriers/enablers they encountered. Interviews were audiorecorded, transcribed verbatim and analysed following the principles of the constant comparative method.
RESULTS


Twenty-six interviews were conducted (11 North East, 10 North West and 5 Wales). Iterative data analysis identified four key themes, which reflected paramedics' experiences at different stages of the care pathway: (1) Enhanced assessment at scene: paramedics felt this improved their skillset and confidence. (2) Prealert to hospital: a mixed experience dependent on receiving hospital staff. (3) Handover to hospital team: standardisation of format was viewed as the primary benefit of the PASTA pathway. (4) Assisting in hospital and feedback: due to professional boundaries, paramedics found these aspects harder to achieve, although feedback from the clinical team was valued when available.
CONCLUSION


Paramedics believed that the PASTA pathway enhanced their skills and the emergency care of stroke patients, but a continuing clinical role postadmission was challenging. Future studies should consider whether interdisciplinary training is needed to enable more radical extension of professional boundaries for paramedics.",2020,The Paramedic Acute Stroke Treatment Assessment (PASTA) multicentre cluster randomised controlled trial evaluated whether an enhanced paramedic-initiated stroke assessment pathway could improve thrombolysis volume.,"['Twenty-six interviews were conducted (11 North East, 10 North West and 5 Wales', 'Interviewees were recruited from 453 trained intervention paramedics across three UK ambulance services hosting the trial: North East, North West and Welsh Ambulance Services']",[],['thrombolysis volume'],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043114', 'cui_str': 'Welsh'}]",[],"[{'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",26.0,0.046024,The Paramedic Acute Stroke Treatment Assessment (PASTA) multicentre cluster randomised controlled trial evaluated whether an enhanced paramedic-initiated stroke assessment pathway could improve thrombolysis volume.,"[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lally', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Vaittinen', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'McClelland', 'Affiliation': 'Research and Development, North East Ambulance Service NHS Foundation Trust, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Price', 'Affiliation': 'Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK c.i.m.price@ncl.ac.uk.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Shaw', 'Affiliation': 'Stroke Research Group, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Gary A', 'Initials': 'GA', 'LastName': 'Ford', 'Affiliation': 'Medical Sciences Division, University of Oxford, and Oxford University Hospitals NHS Foundation Trust, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Flynn', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Exley', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}]",Emergency medicine journal : EMJ,['10.1136/emermed-2019-209392']
1174,32546491,Randomised controlled trial assessing the effect of a technology-assisted gait and balance training on mobility in older people after hip fracture: study protocol.,"INTRODUCTION


Deficits in balance and walking ability are relevant risk factors for falls during ageing. Moreover, falls are a risk factor for future falls, strongly associated with adverse health outcomes, such as fear of falling or fractures, particularly, hip fracture. For this reason, the development of prevention tools and innovative rehabilitation strategies is one of the main objectives in geriatrics. Effective interventions to promote hip recovery after hip fracture are characterised by intensive and repetitive movements. One treatment approach is to increase the number of steps during the rehabilitation sessions and to improve the balance and the endurance of the patients in the use of technological devices.
METHODS AND ANALYSIS


This randomised controlled trial aimed to evaluate an innovative rehabilitation treatment of elderly patients with hip fractures. A total of 195 patients with hip fractures will be recruited and randomly divided into three groups: traditional rehabilitation programme, traditional rehabilitation programme plus TYMO system and traditional rehabilitation programme plus Walker View. Assessments will be performed at baseline, at the end of treatment, at 6 months, and at 1 and 2 years after the end of the treatment. Only subjects hospitalised 4 weeks prior to the beginning of the study will be taken into consideration. Twenty treatment sessions will be conducted, divided into three training sessions per week, for 7 weeks. The technological intervention group will carry out 30 min sessions of traditional therapy and 20 min of treatment with a technological device. The control group will perform traditional therapy sessions, each lasting 50 min. The primary outcomes are risk of falling, gait performance and fear of falling.
ETHICS AND DISSEMINATION


The study was approved by the Istituto di Ricerca e Cura a Carattere Scientifica, Istituto Nazionale Ricovero e Cura Anziani Ethics Committee, with identification code number 19 014. Trial results will be submitted for publication in journals and conferences.
TRIAL REGISTRATION NUMBER


NCT04095338.",2020,"Moreover, falls are a risk factor for future falls, strongly associated with adverse health outcomes, such as fear of falling or fractures, particularly, hip fracture.","['older people after hip fracture', '195 patients with hip fractures', 'elderly patients with hip fractures']","['innovative rehabilitation treatment', 'technology-assisted gait and balance training', 'traditional rehabilitation programme, traditional rehabilitation programme plus TYMO system and traditional rehabilitation programme plus Walker View']","['risk of falling, gait performance and fear of falling']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0043016', 'cui_str': 'Walker'}, {'cui': 'C0449911', 'cui_str': 'View'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0877040', 'cui_str': 'Fear of falling'}]",195.0,0.0345737,"Moreover, falls are a risk factor for future falls, strongly associated with adverse health outcomes, such as fear of falling or fractures, particularly, hip fracture.","[{'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Maranesi', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Giovanni Renato', 'Initials': 'GR', 'LastName': 'Riccardi', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Fabrizia', 'Initials': 'F', 'LastName': 'Lattanzio', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Di Rosa', 'Affiliation': 'Unit of Geriatric Pharmacoepidemiology, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Luzi', 'Affiliation': 'Medical Direction, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Casoni', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Rinaldi', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Baldoni', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Ancona, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Di Donna', 'Affiliation': 'Clinical Unit of Physical Rehabilitation, IRCCS INRCA, Fermo, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Bevilacqua', 'Affiliation': 'Scientific Direction, IRCCS INRCA, Ancona, Italy r.bevilacqua@inrca.it.'}]",BMJ open,['10.1136/bmjopen-2019-035508']
1175,32546646,ESR1  Mutations and Overall Survival on Fulvestrant versus Exemestane in Advanced Hormone Receptor-Positive Breast Cancer: A Combined Analysis of the Phase III SoFEA and EFECT Trials.,"PURPOSE


ESR1  mutations are acquired frequently in hormone receptor-positive metastatic breast cancer after prior aromatase inhibitors. We assessed the clinical utility of baseline  ESR1  circulating tumor DNA (ctDNA) analysis in the two phase III randomized trials of fulvestrant versus exemestane.
EXPERIMENTAL DESIGN


The phase III EFECT and SoFEA trials randomized patients with hormone receptor-positive metastatic breast cancer who had progressed on prior nonsteroidal aromatase inhibitor therapy, between fulvestrant 250 mg and exemestane. Baseline serum samples from 227 patients in EFECT, and baseline plasma from 161 patients in SoFEA, were analyzed for  ESR1  mutations by digital PCR. The primary objectives were to assess the impact of  ESR1  mutation status on progression-free (PFS) and overall survival (OS) in a combined analysis of both studies.
RESULTS


ESR1  mutations were detected in 30% (151/383) baseline samples. In patients with  ESR1  mutation detected, PFS was 2.4 months [95% confidence interval (CI), 2.0-2.6] on exemestane and 3.9 months (95% CI, 3.0-6.0) on fulvestrant [hazard ratio (HR), 0.59; 95% CI, 0.39-0.89;  P  = 0.01). In patients without  ESR1  mutations detected, PFS was 4.8 months (95% CI, 3.7-6.2) on exemestane and 4.1 months (95% CI, 3.6-5.5) on fulvestrant (HR, 1.05; 95% CI, 0.81-1.37;  P  = 0.69). There was an interaction between  ESR1  mutation and treatment ( P  = 0.02). Patients with  ESR1  mutation detected had 1-year OS of 62% (95% CI, 45%-75%) on exemestane and 80% (95% CI, 68%-87%) on fulvestrant ( P  = 0.04; restricted mean survival analysis). Patients without  ESR1  mutations detected had 1-year OS of 79% (95% CI, 71%-85%) on exemestane and 81% (95% CI, 74%-87%) on fulvestrant ( P  = 0.69).
CONCLUSIONS


Detection of  ESR1  mutations in baseline ctDNA is associated with inferior PFS and OS in patients treated with exemestane versus fulvestrant.",2020,"In patients with  ESR1  mutation detected, PFS was 2.4 months (95%CI,2.0-2.6) on exemestane and 3.9 months (95%CI,3.0-6.0) on fulvestrant (HR=0.59, 95%CI,0.39-0.89; p=0.01).","['patients with HR+ metastatic breast cancer who had progressed on prior non-steroidal AI, between', '227 patients in EFECT, and baseline plasma from 161 patients in SoFEA', 'advanced hormone receptor positive breast cancer']","['fulvestrant 250mg and exemestane', 'exemestane', 'fulvestrant', 'fulvestrant versus exemestane', 'exemestane versus fulvestrant']","['one-year overall survival', 'PFS', 'ESR1 mutations and overall survival', 'inferior progression-free and overall survival', 'impact of  ESR1  mutation status on progression-free and overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}]","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1521863', 'cui_str': 'estrogen receptor alpha, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.393116,"In patients with  ESR1  mutation detected, PFS was 2.4 months (95%CI,2.0-2.6) on exemestane and 3.9 months (95%CI,3.0-6.0) on fulvestrant (HR=0.59, 95%CI,0.39-0.89; p=0.01).","[{'ForeName': 'Nicholas C', 'Initials': 'NC', 'LastName': 'Turner', 'Affiliation': 'Breast Cancer Now Research Centre, The Institute of Cancer Research, London, United Kingdom. Nick.Turner@icr.ac.uk.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Swift', 'Affiliation': 'Breast Unit, The Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Kilburn', 'Affiliation': 'ICR-CTSU, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Fribbens', 'Affiliation': 'Breast Cancer Now Research Centre, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Beaney', 'Affiliation': 'Breast Cancer Now Research Centre, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Garcia-Murillas', 'Affiliation': 'Breast Cancer Now Research Centre, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Aman U', 'Initials': 'AU', 'LastName': 'Budzar', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'John F R', 'Initials': 'JFR', 'LastName': 'Robertson', 'Affiliation': 'University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Gradishar', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Schiavon', 'Affiliation': 'R&D Oncology, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Bliss', 'Affiliation': 'ICR-CTSU, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Mitch', 'Initials': 'M', 'LastName': 'Dowsett', 'Affiliation': 'Breast Cancer Now Research Centre, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Stephen R D', 'Initials': 'SRD', 'LastName': 'Johnston', 'Affiliation': 'Breast Unit, The Royal Marsden Hospital, London, United Kingdom.'}, {'ForeName': 'Stephen K', 'Initials': 'SK', 'LastName': 'Chia', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0224']
1176,32682996,THR1VE! Positive psychology intervention to treat diabetes distress in teens with type 1 diabetes: Rationale and trial design.,"Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control. Building on effective positive psychology interventions to improve adherence in adults, as well as our pilot work to adapt these interventions for adolescents, we developed a positive psychology intervention for adolescents with T1D. The goal of THR1VE! is to reduce diabetes distress in adolescents with T1D and improve their diabetes outcomes. This multi-site randomized controlled trial compares a Diabetes Education + text-message-based Positive Affect intervention, to a Diabetes Education control condition. In the ongoing trial, we are evaluating the effects of the intervention on adolescents' diabetes distress, self-management, and glycemic control. This paper describes the rationale, trial design, and methodology of the THR1VE! Study.",2020,"Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control.","['Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress', 'teens with type 1 diabetes', 'adolescents with T1D']","['Diabetes Education + text-message-based Positive Affect intervention', 'Positive psychology intervention']","[""adolescents' diabetes distress, self-management, and glycemic control"", 'diabetes distress']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0417244,"Adolescents with type 1 diabetes (T1D) experience high rates of diabetes distress, which negatively influence self-management and glycemic control.","[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Jaser', 'Affiliation': 'Vanderbilt University Medical Center, USA. Electronic address: sarah.jaser@vumc.org.'}, {'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Datye', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Troy', 'Initials': 'T', 'LastName': 'Morrow', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Sinisterra', 'Affiliation': ""Children's National Hospital, USA.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'LeStourgeon', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Fayo', 'Initials': 'F', 'LastName': 'Abadula', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Grace E', 'Initials': 'GE', 'LastName': 'Bell', 'Affiliation': 'Vanderbilt University Medical Center, USA.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Streisand', 'Affiliation': ""Children's National Hospital, USA.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106086']
1177,32497520,"39·0°C versus 38·5°C ear temperature as fever limit in children with neutropenia undergoing chemotherapy for cancer: a multicentre, cluster-randomised, multiple-crossover, non-inferiority trial.","BACKGROUND


Fever in neutropenia is the most frequent complication of chemotherapy for cancer. The temperature limit defining fever used clinically varies. A higher limit can avoid unnecessary diagnoses in patients spontaneously recovering from fever. This trial primarily aimed to determine if a limit of 39·0°C ear temperature is non-inferior to 38·5°C regarding safety.
METHODS


This cluster-randomised, multiple crossover, non-blinded, non-inferiority trial was done in six Swiss Paediatric Oncology Group centres (clusters) in Switzerland. Patients (aged 1 to <18 years) with any malignancy and treated with myelosuppressive chemotherapy expected to last 2 months or more were repeatedly randomly assigned (1:1), at the cluster level, to either monthly 39·0°C or 38·5°C ear temperature limits for diagnosis of fever in neutropenia. Diagnosis below the randomised limit was allowed for clinical reasons. Such a diagnosis implied emergency hospitalisation, examinations (including blood culture), as-needed antipyretics, and empirical intravenous broad-spectrum antibiotics. The primary outcome was the rate of fever in neutropenia with safety relevant events (SRE) per chemotherapy year; we also assessed efficacy in terms of rate of fever in neutropenia. The non-inferiority margin was 1·33 for safety, and for effiacy, the superiority margin was 1·00. This trial is registered at ClinicalTrials.gov, number NCT02324231.
FINDINGS


269 patients were recruited between April 28, 2016, to Aug 27, 2018, until the trial was stopped for success after the second interim analysis. Patients were repeatedly randomly assigned, with 1210 (48%) of 2547 randomisation periods and 92 (47%) of 195 chemotherapy years randomised to 39·0°C. SREs were diagnosed in 72 (20%) of 360 fever in neutropenia episodes (zero deaths, 16 intensive care unit admissions, 22 cases of severe sepsis, and 56 cases of bacteraemia). In 92 chemotherapy years randomised to the 39·0°C fever limit, 151 episodes of fever with neutropenia were diagnosed (1·64 per year), including 22 (15%) with SRE (0·24 per year). In 103 chemotherapy years randomised to 38·5°C, 209 episodes were diagnosed (2·03 per year), including 50 (24%) with SRE (0·49 per year). The mixed Poisson regression rate ratio (RR) of fever in neutropenia with SRE in 39·0°C versus 38·5°C was 0·56 (95% upper confidence bound 0·72). The corresponding RR of fever in neutropenia was 0·83 (95% upper confidence bound 0·98).
INTERPRETATION


In children with neutropenia and chemotherapy for cancer, 39·0°C ear temperature was safe and seemed efficacious. For Switzerland and comparable settings, 39·0°C can be recommended as new evidence-based standard fever limit except for patients with acute myeloid leukaemia or haematopoietic stem cell transplantation.
FUNDING


Swiss Cancer League (KLS-3645-02-2015).",2020,The corresponding RR of fever in neutropenia was 0·83,"['patients spontaneously recovering from fever', 'children with neutropenia undergoing chemotherapy for cancer', '269 patients were recruited between April 28, 2016, to Aug 27, 2018, until the trial was stopped for success after the second interim analysis', '103 chemotherapy years randomised to 38·5', 'six Swiss Paediatric Oncology Group centres (clusters) in Switzerland', 'patients with acute myeloid leukaemia or haematopoietic stem cell transplantation', 'Patients (aged 1 to <18 years) with any malignancy and treated with myelosuppressive chemotherapy expected to last 2 months or more were repeatedly randomly assigned (1:1), at the cluster level, to either monthly 39·0°C or 38·5']",[],"['rate of fever in neutropenia', 'fever with neutropenia', 'mixed Poisson regression rate ratio (RR) of fever in neutropenia with SRE', 'SREs', 'corresponding RR of fever in neutropenia', 'rate of fever in neutropenia with safety relevant events (SRE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",[],"[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",269.0,0.380971,The corresponding RR of fever in neutropenia was 0·83,"[{'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'Koenig', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bodmer', 'Affiliation': ""Pediatric Oncology, University Children's Hospital of Zürich, University of Zürich, Zürich, Switzerland.""}, {'ForeName': 'Philipp K A', 'Initials': 'PKA', 'LastName': 'Agyeman', 'Affiliation': 'Department of Pediatrics, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Niggli', 'Affiliation': ""Pediatric Oncology, University Children's Hospital of Zürich, University of Zürich, Zürich, Switzerland.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Adam', 'Affiliation': 'Unit of Pediatric Hematology-Oncology, Woman-Mother-Child Department, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ansari', 'Affiliation': 'Division of Pediatric Hematology and Oncology, Department of Pediatrics and Adolescent Medicine, University Hospital of Geneva, Geneva, Switzerland; Department of Paediatrics, CANSEARCH Research Laboratory, Faculty of Medicine, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Eisenreich', 'Affiliation': ""Department of Pediatric Oncology and Hematology, Children's Hospital Lucerne, Lucerne, Switzerland.""}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Keller', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Leibundgut', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nadal', 'Affiliation': ""Pediatric Oncology, University Children's Hospital of Zürich, University of Zürich, Zürich, Switzerland.""}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Roessler', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Scheinemann', 'Affiliation': ""Division of Pediatric Hematology and Oncology, Department of Pediatrics, Kantonsspital Aarau, Aarau, Switzerland; Division of Pediatric Hematology and Oncology, University Children's Hospital Basel, University of Basel, Basel, Switzerland; Department of Pediatrics, McMaster Children's Hospital and McMaster University, Hamilton, ON, Canada.""}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Simon', 'Affiliation': ""Department of Pediatric Hematology and Oncology, Children's Hospital Medical Centre, University Hospital of Saarland, Homburg, Germany.""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Teuffel', 'Affiliation': 'University of Tuebingen, Tuebingen, Germany; Division of Oncology, Medical Services of the Statutory Health Insurance, Baden-Wuerttemberg, Germany.'}, {'ForeName': 'Nicolas X', 'Initials': 'NX', 'LastName': 'von der Weid', 'Affiliation': ""Division of Pediatric Hematology and Oncology, University Children's Hospital Basel, University of Basel, Basel, Switzerland.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zeller', 'Affiliation': 'Swiss Paediatric Oncology Group, Coordinating Centre, Bern, Switzerland.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Zimmermann', 'Affiliation': ""Children's Research Centre, University Children's Hospital of Zürich, University of Zürich, Zürich, Switzerland; Department Public Health-Nursing Science, Faculty of Medicine, University Basel, Basel, Switzerland.""}, {'ForeName': 'Roland A', 'Initials': 'RA', 'LastName': 'Ammann', 'Affiliation': 'Pediatric Hematology and Oncology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. Electronic address: roland.ammann@insel.ch.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30092-4']
1178,32506498,Negative-pressure wound therapy does not reduce superficial SSI in pancreatectomy and hepatectomy procedures.,"INTRODUCTION


Surgical site infections (SSIs) lead to increased morbidity and cost. Negative-pressure wound therapy (NPWT) removes wound exudate and improves local blood flow, but its effect on SSI is unproven following hepatectomy and pancreatectomy. The aim of this trial was to evaluate the effect of NPWT on SSI in this population.
METHODS


Patients were randomized to incisional NPWT or sterile island dressing following surgery. SSI predictive factors were recorded as well as patient comorbidities. Wound complications and type of SSI were recorded prospectively.
RESULTS


Forty patients received the standardized perioperative bundle. Twenty patients received sterile island: 11 hepatic and 9 pancreatic resections; 20 patients received NPWT: 11 hepatic and 9 pancreatic resections; 23 patients were male; mean age 60.8 years (SD ±10.3); mean BMI 31.7 (SD ±7.0). There were three incisional wound infections: two with sterile island, one with NPWT; six organ space infections: four sterile island and two NPWT. There were no significant differences in SSI rates between groups (P = .57).
CONCLUSION


NPWT does not improve SSI rates over simple sterile dressing following hepatectomy or pancreatectomy. Improvements in SSI must be directed toward organ-space infections, which are unaffected by NPWT.",2020,"There were no significant differences in SSI rates between groups (P = .57).
","['Twenty patients received sterile island: 11 hepatic and 9 pancreatic resections; 20 patients received NPWT: 11 hepatic and 9 pancreatic resections; 23 patients were male; mean age 60.8 years (SD ±10.3); mean BMI 31.7 (SD ±7.0', 'Forty patients received the standardized perioperative bundle', 'Patients']","['Negative-pressure wound therapy', 'NPWT', 'Negative-pressure wound therapy (NPWT', 'incisional NPWT or sterile island dressing following surgery']","['incisional wound infections', 'SSI rates', 'superficial SSI', 'Wound complications and type of SSI', 'local blood flow', 'SSI predictive factors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0854522', 'cui_str': 'Pancreatic resection'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4708784', 'cui_str': '31.7'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",23.0,0.083828,"There were no significant differences in SSI rates between groups (P = .57).
","[{'ForeName': 'Conor H', 'Initials': 'CH', 'LastName': ""O'Neill"", 'Affiliation': 'Hiram Polk Jr. MD, Department of Surgery, Division of Surgical Oncology, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Robert C G', 'Initials': 'RCG', 'LastName': 'Martin', 'Affiliation': 'Hiram Polk Jr. MD, Department of Surgery, Division of Surgical Oncology, University of Louisville, Louisville, Kentucky.'}]",Journal of surgical oncology,['10.1002/jso.25980']
1179,32506513,Use of metabolic syndrome severity to assess treatment with vitamin E and pioglitazone for non-alcoholic steatohepatitis.,"BACKGROUND AND AIM


Non-alcoholic steatohepatitis (NASH), which can lead to liver failure, requires liver biopsies to follow and is difficult to treat. Our goal was to assess metabolic syndrome (MetS) severity as a predictor of treatment success and a marker of response.
METHODS


We assessed data from the Pioglitazone, Vitamin E, or Placebo for NASH Study, in which individuals with biopsy-confirmed NASH were randomized to receive pioglitazone, vitamin E, or placebo for 96 weeks. We assessed associations of a sex-specific and race/ethnicity-specific MetS severity Z-score (MetS-Z) at baseline and 48 weeks with biopsy-determined endpoint of NASH resolution at 96 weeks.
RESULTS


Baseline MetS-Z was inversely associated with odds of NASH resolution (odds ratio [OR] per 1 SD of MetS-Z: 0.47, 95% confidence interval [CI] 0.28, 0.79). Decrease in MetS-Z during initial 48-week intervention was greatest for pioglitazone treatment (effect size: -0.31, 95% CI -0.15, -0.48) and for vitamin E tended toward being greater for those with versus without NASH resolution (-0.18 vs -0.05). Overall, 48-week change in MetS-Z was associated with NASH resolution (OR per 1-SD change: 0.53, 95% CI 0.33, 0.85), although this was attenuated in models that included transaminases, which remained linked to treatment success (OR by change-in-aspartate aminotransferase Z-score: 0.38, 95% CI 0.19, 0.76).
CONCLUSIONS


Individuals with more severe metabolic derangement at baseline were less likely to exhibit NASH resolution, suggesting that individuals may have a threshold of MetS severity beyond which successful treatment is unlikely. As an integrated marker of metabolic abnormalities, MetS-Z was correlated with successful treatment, although transaminases were a more consistent marker of NASH resolution.",2020,"As an integrated marker of metabolic abnormalities, MetS-Z was correlated with successful treatment, though transaminases were a more consistent marker of NASH resolution.","['Non-alcoholic Steatohepatitis', 'individuals with biopsy-confirmed NASH']","['pioglitazone', 'Vitamin-E and Pioglitazone', 'pioglitazone, vitamin-E or placebo', 'Pioglitazone, Vitamin-E or Placebo NASH Study (PIVENS']","['NASH resolution', 'MetS-Z', 'metabolic syndrome (MetS) severity']","[{'cui': 'C3241937', 'cui_str': 'Nonalcoholic steatohepatitis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}]","[{'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.680429,"As an integrated marker of metabolic abnormalities, MetS-Z was correlated with successful treatment, though transaminases were a more consistent marker of NASH resolution.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gurka', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Jasmine A', 'Initials': 'JA', 'LastName': 'Mack', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Chi', 'Affiliation': 'Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'DeBoer', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Endocrinology, University of Virginia, Charlottesville, Virginia, USA.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15131']
1180,32510462,Effectiveness of a 3-Month Mobile Phone-Based Behavior Change Program on Active Transportation and Physical Activity in Adults: Randomized Controlled Trial.,"BACKGROUND


Active transportation (AT; ie, walking and cycling as a mode for transportation) has been associated with decreased morbidity and mortality; however, low-cost and scalable intervention programs are lacking.
OBJECTIVE


The goal of the research was to determine the effectiveness of a 3-month behavior change program delivered via a mobile phone app to promote AT (TravelVu Plus) on time spent in moderate-to-vigorous physical activity (MVPA).
METHODS


For this 2-arm parallel randomized controlled trial, we recruited a population-based sample of 254 adults from Stockholm County who were aged 20 to 65 years and had access to a smartphone. On completion of 1-week baseline measures, the 254 participants were randomized to either the control or intervention group (1:1 ratio). Both groups had access to the standard TravelVu app (Trivector AB) for monitoring their AT for 6 months. The intervention group also received a 3-month behavior change program to promote AT (TravelVu Plus app). Assessors of outcomes were blinded to group allocation. Outcomes were objectively measured MVPA at 3 (primary) and 6 months. Secondary outcomes were AT, attitudes toward AT, and health-related quality of life at 3 and 6 months.
RESULTS


No effect on MVPA was observed after 3 months (P=.29); however, at 6 months the intervention group had a greater improvement in MVPA than the controls (6.05 minutes per day [95% CI 0.36 to 11.74; P=.04]). A Bayesian analyses showed that there was a 98% probability that the intervention had any effect at 6 months, and a 63% probability that this effect was >5 minute MVPA per day.
CONCLUSIONS


No effect on MVPA immediately after the intervention period (at 3 months) was observed; however, there was a delayed effect on MVPA (6 minutes per day) at 6 months, which corresponds to approximately 30% of the weekly MVPA recommendation. Our findings suggest that a behavior change program promoting AT delivered via an app may have a relevant effect on PA.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03086837; https://clinicaltrials.gov/ct2/show/NCT03086837.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.1186/s12889-018-5658-4.",2020,"No effect on MVPA was observed after 3 months (P=.29); however, at 6 months the intervention group had a greater improvement in MVPA than the controls (6.05 minutes per day [95% CI 0.36 to 11.74; P=.04]).","['254 adults from Stockholm County who were aged 20 to 65 years and had access to a smartphone', 'Adults', '254 participants']","['3-Month Mobile Phone-Based Behavior Change Program', '3-month behavior change program to promote AT (TravelVu Plus app', 'mobile phone app to promote AT (TravelVu Plus', 'MVPA']","['MVPA', 'Active Transportation and Physical Activity', 'AT, attitudes toward AT, and health-related quality of life at 3 and 6 months']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",254.0,0.218912,"No effect on MVPA was observed after 3 months (P=.29); however, at 6 months the intervention group had a greater improvement in MVPA than the controls (6.05 minutes per day [95% CI 0.36 to 11.74; P=.04]).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ek', 'Affiliation': 'Department of Clinical Science Intervention and Technology, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Alexandrou', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping, Sweden.'}, {'ForeName': 'Emmie', 'Initials': 'E', 'LastName': 'Söderström', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping, Sweden.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Bergman', 'Affiliation': 'eHealth Institute, Department of Medicine and Optometry, Linnaeus University, Kalmar, Sweden.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Delisle Nyström', 'Affiliation': 'Department of Biosciences and Nutrition, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Direito', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Eriksson', 'Affiliation': 'Strömstad Academy, Strömstad, Sweden.'}, {'ForeName': 'Pontus', 'Initials': 'P', 'LastName': 'Henriksson', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping, Sweden.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Maddison', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Trolle Lagerros', 'Affiliation': 'Department of Medicine, Clinical Epidemiology Unit, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bendtsen', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Löf', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping, Sweden.'}]",JMIR mHealth and uHealth,['10.2196/18531']
1181,32512291,"Rationale and design of the PRAETORIAN-COVID trial: A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease.","There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients. Although it has been suggested that ARBs might lead to a higher susceptibility and severity of SARS-CoV-2 infection, experimental data suggest that ARBs may reduce acute lung injury via blocking angiotensin-II-mediated pulmonary permeability, inflammation, and fibrosis. However, despite these hypotheses, specific studies on ARBs in SARS-CoV-2 patients are lacking. METHODS: The PRAETORIAN-COVID trial is a multicenter, double-blind, placebo-controlled 1:1 randomized clinical trial in adult hospitalized SARS-CoV-2-infected patients (n = 651). The primary aim is to investigate the effect of the ARB valsartan compared to placebo on the composite end point of admission to an intensive care unit, mechanical ventilation, or death within 14 days of randomization. The active-treatment arm will receive valsartan in a dosage titrated to blood pressure up to a maximum of 160 mg bid, and the placebo arm will receive matching placebo. Treatment duration will be 14 days, or until the occurrence of the primary end point or until hospital discharge, if either of these occurs within 14 days. The trial is registered at clinicaltrials.gov (NCT04335786, 2020). SUMMARY: The PRAETORIAN-COVID trial is a double-blind, placebo-controlled 1:1 randomized trial to assess the effect of valsartan compared to placebo on the occurrence of ICU admission, mechanical ventilation, and death in hospitalized SARS-CoV-2-infected patients. The results of this study might impact the treatment of SARS-CoV-2 patients globally.",2020,There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients.,"['hospitalized SARS-CoV-2-infected patients', 'hospitAlized patieNts with SARS-COV-2 Infection Disease', 'severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients', 'adult hospitalized SARS-CoV-2-infected patients (n = 651']","['valsartan', 'ARB valsartan', 'angiotensin receptor blockers (ARBs', 'placebo arm will receive matching placebo', 'placebo']","['occurrence of ICU admission, mechanical ventilation, and death']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.592181,There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients.,"[{'ForeName': 'D H Frank', 'Initials': 'DHF', 'LastName': 'Gommans', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands. Electronic address: frank.gommans@radboudumc.nl.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Nas', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Sara-Joan', 'Initials': 'SJ', 'LastName': 'Pinto-Sietsma', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Koop', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Regina E', 'Initials': 'RE', 'LastName': 'Konst', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Mensink', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Goaris W A', 'Initials': 'GWA', 'LastName': 'Aarts', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Lara S F', 'Initials': 'LSF', 'LastName': 'Konijnenberg', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Cortenbach', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Dominique V M', 'Initials': 'DVM', 'LastName': 'Verhaert', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center (MUMC+), Maastricht, the Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Thannhauser', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Jan-Quinten', 'Initials': 'JQ', 'LastName': 'Mol', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Maxim J P', 'Initials': 'MJP', 'LastName': 'Rooijakkers', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Jacqueline L', 'Initials': 'JL', 'LastName': 'Vos', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Anouke', 'Initials': 'A', 'LastName': 'van Rumund', 'Affiliation': 'Department of Neurology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vart', 'Affiliation': 'Department of Biostatistics, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'Hassing', 'Affiliation': 'Department of Internal Medicine, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Jan-Hein', 'Initials': 'JH', 'LastName': 'Cornel', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands.'}, {'ForeName': 'C Peter C', 'Initials': 'CPC', 'LastName': 'de Jager', 'Affiliation': ""Department of Intensive Care, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Pulmonary diseases, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, ErasmusMC, Rotterdam, the Netherlands.'}, {'ForeName': 'Yigal M', 'Initials': 'YM', 'LastName': 'Pinto', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Roland R J', 'Initials': 'RRJ', 'LastName': 'van Kimmenade', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Internal Medicine, Maastricht UMC, Maastricht, the Netherlands.'}, {'ForeName': 'Michiel A', 'Initials': 'MA', 'LastName': 'van Agtmael', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bresser', 'Affiliation': 'Department of Pulmonary Diseases, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Wiek H', 'Initials': 'WH', 'LastName': 'van Gilst', 'Affiliation': 'Department of Experimental Cardiology, UMCG, Groningen, the Netherlands.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Vonk-Noordergraaf', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'C Peter C', 'Initials': 'CPC', 'LastName': 'de Jager', 'Affiliation': ""Department of Intensive Care, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Pulmonary diseases, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, ErasmusMC, Rotterdam, the Netherlands.'}, {'ForeName': 'Yigal M', 'Initials': 'YM', 'LastName': 'Pinto', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Roland R J', 'Initials': 'RRJ', 'LastName': 'van Kimmenade', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}]",American heart journal,['10.1016/j.ahj.2020.05.010']
1182,32522066,"Refined Deep Seawater Improves Serum Lipid Profile in Hypercholesterolemia: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial.","Deep seawater (DSW) has been investigated for its lipid-lowering effects, but clinical evidence is still far from conclusive. Therefore, this study was conducted to examine the effects of refined DSW (RDSW) on hypercholesterolemia. In this randomized, double-blind, placebo-controlled trial, 78 Korean participants were randomized to either an RDSW group that drank RDSW for 8 weeks or a placebo group. Clinical laboratory information was collected from all subjects at 0, 4, and 8 weeks. Both groups showed a significant reduction in total cholesterol (TC), whereas only the RDSW group demonstrated a significant decrease in low-density lipoprotein cholesterol (LDL-c) during the study. Stratified analysis of both groups revealed a significant reduction of TC in the moderately high TC subgroup. However, only the RDSW exhibited a significant decline of LDL-c in the high LDL-c subgroup. In addition, lipoprotein(a) decreased significantly in the RDSW group, but not in the placebo. RDSW did not affect other lipid profiles, including high-density lipoprotein cholesterol (HDL-c), triglyceride, free fatty acid, apolipoproteins, and other markers including inflammation marker, hematological parameters, blood and urine chemistry, and vital signs. RDSW improved lipid profiles by decreasing TC and LDL-c while maintaining HDL-c levels in people with hypercholesterolemia.",2020,"Both groups showed a significant reduction in total cholesterol (TC), whereas only the RDSW group demonstrated a significant decrease in low-density lipoprotein cholesterol (LDL-c) during the study.","['people with hypercholesterolemia', 'Hypercholesterolemia', '78 Korean participants']","['refined DSW (RDSW', 'Placebo', 'RDSW group that drank RDSW', 'placebo']","['high-density lipoprotein cholesterol (HDL-c), triglyceride, free fatty acid, apolipoproteins, and other markers including inflammation marker, hematological parameters, blood and urine chemistry, and vital signs', 'total cholesterol (TC', 'low-density lipoprotein cholesterol (LDL-c', 'LDL-c']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0007996', 'cui_str': 'Chemistry'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",78.0,0.384953,"Both groups showed a significant reduction in total cholesterol (TC), whereas only the RDSW group demonstrated a significant decrease in low-density lipoprotein cholesterol (LDL-c) during the study.","[{'ForeName': 'Min-Jee', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine of Korean Medicine, Dongguk University, Goyang, Korea.'}, {'ForeName': 'Chi-Yeon', 'Initials': 'CY', 'LastName': 'Lim', 'Affiliation': 'Department of Biostatistics, School of Medicine, Dongguk University, Gyeongju, Korea.'}, {'ForeName': 'Kyu-Shik', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Pharmacology and Intractable Disease Research Center, School of Medicine, Dongguk University, Gyeongju, Korea.'}, {'ForeName': 'Kyung-Soo', 'Initials': 'KS', 'LastName': 'Nam', 'Affiliation': 'Department of Pharmacology and Intractable Disease Research Center, School of Medicine, Dongguk University, Gyeongju, Korea.'}, {'ForeName': 'Hojun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine of Korean Medicine, Dongguk University, Goyang, Korea.'}]",Journal of medicinal food,['10.1089/jmf.2019.4658']
1183,32526188,"Efficacy, duration of protection, birth outcomes, and infant growth associated with influenza vaccination in pregnancy: a pooled analysis of three randomised controlled trials.","BACKGROUND


Maternal influenza immunisation can reduce morbidity and mortality associated with influenza infection in pregnant women and young infants. We aimed to determine the vaccine efficacy of maternal influenza immunisation against maternal and infant PCR-confirmed influenza, duration of protection, and the effect of gestational age at vaccination on vaccine efficacy, birth outcomes, and infant growth up to 6 months of age.
METHODS


We did a pooled analysis of three randomised controlled trials done in Nepal (2011-2014), Mali (2011-2014), and South Africa (2011-2013). Pregnant women, gestational age 17-34 weeks in Nepal, 28 weeks or more in Mali, and 20-36 weeks in South Africa, were enrolled. Women were randomly assigned 1:1 to a study group, in which they received trivalent inactivated influenza vaccine (IIV) in all three trials, or a control group, in which they received saline placebo in Nepal and South Africa or quadrivalent meningococcal conjugate vaccine in Mali. Enrolment at all sites was complete by April 24, 2013. Infants and women were assessed for respiratory illness, and samples from those that met the case definition were tested for influenza by PCR testing. Growth measurements, including length and weight, were obtained at birth at all sites, at 24 weeks in South Africa, and at 6 months in Nepal and Mali. The three trials are registered with ClinicalTrials.gov, numbers NCT01430689, NCT01034254, and NCT02465190.
FINDINGS


10 002 women and 9800 liveborn infants were included. Pooled efficacy of maternal vaccination to prevent infant PCR-confirmed influenza up to 6 months of age was 35% (95% CI 19 to 47). The pooled estimate was 56% (28 to 73) within the first 2 months of life, 39% (11 to 58) between 2 and 4 months, and 19% (-9 to 40) between 4 and 6 months. In women, from enrolment during pregnancy to the end of follow-up at 6 months postpartum, the vaccine was 50% (95% CI 32-63) efficacious against PCR-confirmed influenza. Efficacy was 42% (12 to 61) during pregnancy and 60% (36 to 75) postpartum. In women vaccinated before 29 weeks gestational age, the estimated efficacy was 30% (-2 to 52), and in women vaccinated at or after 29 weeks, efficacy was 71% (50 to 83). Efficacy was similar in infants born to mothers vaccinated before or after 29 weeks gestation (34% [95% CI 12 to 51] vs 35% [11 to 52]). There was no overall association between maternal vaccination and low birthweight, stillbirth, preterm birth, and small for gestational age. At 6 months of age, the intervention and control groups were similar in terms of underweight (weight-for-age), stunted (length-for-age), and wasted (weight-for-length). Median centile change from birth to 6 months of age was similar between the intervention and the control groups for both weight and length.
INTERPRETATION


The assessment of efficacy for women vaccinated before 29 weeks gestational age might have been underpowered, because the point estimate suggests that there might be efficacy despite wide CIs. Estimates of efficacy against PCR-confirmed influenza and safety in terms of adverse birth outcomes should be incorporated into any further consideration of maternal influenza immunisation recommendations.
FUNDING


Bill & Melinda Gates Foundation.",2020,"Median centile change from birth to 6 months of age was similar between the intervention and the control groups for both weight and length.
","['10', 'women vaccinated before 29 weeks gestational age', 'Nepal (2011-2014), Mali (2011-2014), and South Africa (2011-2013', 'pregnant women and young infants', 'pregnancy', '002 women and 9800 liveborn infants were included', 'Pregnant women, gestational age 17-34 weeks in Nepal, 28 weeks or more in Mali, and 20-36 weeks in South Africa, were enrolled']","['maternal influenza immunisation', 'maternal vaccination', 'saline placebo in Nepal and South Africa or quadrivalent meningococcal conjugate vaccine in Mali', 'trivalent inactivated influenza vaccine (IIV']","['vaccine efficacy, birth outcomes, and infant growth', 'maternal vaccination and low birthweight, stillbirth, preterm birth, and small for gestational age', 'Efficacy, duration of protection, birth outcomes, and infant growth', 'Efficacy', 'Growth measurements, including length and weight']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0496655', 'cui_str': 'Singleton, unspecified as to place of birth'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",10002.0,0.36851,"Median centile change from birth to 6 months of age was similar between the intervention and the control groups for both weight and length.
","[{'ForeName': 'Saad B', 'Initials': 'SB', 'LastName': 'Omer', 'Affiliation': 'Yale Institute for Global Health, New Haven, CT, USA; Department of Internal Medicine (Infectious Diseases), Yale School of Medicine, New Haven, CT, USA; Yale School of Nursing, New Haven, CT, USA; Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, USA. Electronic address: saad.omer@yale.edu.'}, {'ForeName': 'Dayna R', 'Initials': 'DR', 'LastName': 'Clark', 'Affiliation': 'Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Milagritos D', 'Initials': 'MD', 'LastName': 'Tapia', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali; Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Marta C', 'Initials': 'MC', 'LastName': 'Nunes', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Eric A F', 'Initials': 'EAF', 'LastName': 'Simões', 'Affiliation': ""Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Section of Infectious Diseases, Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO, USA; Department of Epidemiology, Center for Global Health Colorado School of Public Health, Aurora, CO, USA.""}, {'ForeName': 'Anushka R', 'Initials': 'AR', 'LastName': 'Aqil', 'Affiliation': 'Department of Health, Behavior, Society, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Steinhoff', 'Affiliation': ""Cincinnati Children's Hospital Global Health Center, Cincinnati, OH, USA.""}, {'ForeName': 'Niteen', 'Initials': 'N', 'LastName': 'Wairagkar', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA; Vaccines For All, Pune, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30479-5']
1184,32526210,"Clinical effectiveness of pharmacist-led versus conventionally delivered antiviral treatment for hepatitis C virus in patients receiving opioid substitution therapy: a pragmatic, cluster-randomised trial.","BACKGROUND


Highly effective direct-acting antiviral drugs provide the opportunity to eliminate hepatitis C virus (HCV) infection, but established pathways can be ineffective. We aimed to examine whether a community pharmacy care pathway increased treatment uptake, treatment completion, and cure rates for people receiving opioid substitution therapy, compared with conventional care.
METHODS


This cluster-randomised trial was done in Scottish community pharmacies. Before participants were recruited, pharmacies were randomly assigned (1:1) to refer patients with evidence of HCV antibodies to conventional care or offered them care in the pharmacy (pharmacist-led care). Pharmacies were stratified by location. All pharmacies were trained to offer dried blood spot testing. All eligible participants had received opioid substitution therapy for approximately 3 months, and those eligible to receive treatment in the pharmacist-led care pathway were HCV PCR positive, were infected with HCV genotype 1 or 3, and were willing to have a pharmacist supervise their antiviral drug administration. Neither pharmacists nor patients were masked to treatment allocation. In both groups, assessment blood samples were taken, infection with HCV was confirmed, and daily oral ledipasvir-sofosbuvir (90 mg ledipasivir plus 400 mg sofosbuvir) for 8 weeks for genotype 1 or daily oral sofosbuvir (400 mg) plus oral daclatasvir (60 mg) for 12 weeks for genotype 3 was prescribed by a nurse (conventional care group) or pharmacist (pharmacist-led care group). In the conventional care group, the patient received care at a treatment centre. Once prescribed, medication in both groups was delivered as daily modified directly observed therapy alongside opioid substitution therapy in the participants' pharmacy where treatment was observed on 6 days per week. The primary outcome was the number of patients with sustained virological response 12 weeks after completion of treatment (SVR12) as a proportion of the number of people receiving opioid substitution therapy at participating pharmacies. Participants were monitored at each visit for nausea and fatigue; other adverse events were recorded as free text. Secondary outcomes compared key points on treatment pathway between the two groups. These key points were the proportion of patients having dry blood spot testing, the proportion of patients initiating HCV treatment, the proportion of patients completing the 8 or 12 week HCV course of treatment, and the proportion of patients with sustained virological response at 12 months. This study is registered with ClinicalTrials.gov, NCT02706223.
FINDINGS


56 pharmacies were randomly assigned (28 to each group; one pharmacy withdrew from the conventional care group). The 55 participating pharmacies included 2718 patients receiving opioid substitution therapy (1365 in the pharmacist-led care group and 1353 in the conventional care group). More patients met the primary endpoint of SVR12 in the pharmacist-led care group (98 [7%] of 1365) than in the conventional care group (43 [3%] of 1353; odds ratio 2·375, 95% CI 1·555-3·628, p<0·0001). More users of opioid substitution therapy in the pharmacist-led care group versus the conventional care group agreed to dry blood spot testing (245 [18%] of 1365 vs 145 [11%] of 1353, 2·292, 0·968-5·427, p=0·059); initiated treatment (112 [8%] of 1365 vs 61 [4%] of 1353, 1·889, 1·276-2·789, p=0·0015) and completed treatment (108 [8%] of 1365 vs 58 [4%] of 1353, 1·928, 1·321-2·813, p=0·0007). The data for sustained virological response at 12 months are not reported in this study: patients remain in follow-up for this outcome. No serious adverse events were recorded.
INTERPRETATION


Using pharmacists to deliver an HCV care pathway made testing and treatment more accessible for patients, improved engagement, and maintained high treatment success rates. The use of this pathway could be a key part of an integrated and effective approach to HCV elimination at a community level.
FUNDING


Partnership between the Scottish Government, Gilead Sciences, and Bristol-Myers Squib.",2020,"More users of opioid substitution therapy in the pharmacist-led care group versus the conventional care group agreed to dry blood spot testing (245 [18%] of 1365 vs 145 [11%] of 1353, 2·292, 0·968-5·427, p=0·059); initiated treatment (112 [8%] of 1365 vs 61 [4%] of 1353, 1·889, 1·276-2·789, p=0·0015) and completed treatment (108 [8%] of 1365 vs 58 [4%] of 1353, 1·928, 1·321-2·813, p=0·0007).","['1365 in the pharmacist-led care group and 1353 in the conventional care group', '56 pharmacies', 'patients receiving opioid substitution therapy', 'Scottish community pharmacies', '55 participating pharmacies included 2718 patients receiving', 'people receiving opioid substitution therapy, compared with conventional care', 'for approximately 3 months, and those eligible to receive treatment in the pharmacist-led care pathway were HCV PCR positive, were infected with HCV genotype 1 or 3, and were willing to have a pharmacist supervise their antiviral drug administration']","['opioid substitution therapy', 'oral daclatasvir', 'genotype 3 was prescribed by a nurse (conventional care group) or pharmacist (pharmacist-led care group', 'HCV antibodies to conventional care or offered them care in the pharmacy (pharmacist-led care', 'daily modified directly observed therapy alongside opioid substitution therapy', 'pharmacist-led versus conventionally delivered antiviral treatment']","['sustained virological response', 'nausea and fatigue; other adverse events', 'serious adverse events', 'SVR12', 'number of patients with sustained virological response']","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031321', 'cui_str': 'Pharmacy service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2936530', 'cui_str': 'Opioid Substitution Treatment'}, {'cui': 'C0009478', 'cui_str': 'Community Pharmacies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C3888499', 'cui_str': 'Polymerase chain reaction positive'}, {'cui': 'C3532919', 'cui_str': 'Hepatitis C virus genotype 1'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C2936530', 'cui_str': 'Opioid Substitution Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}, {'cui': 'C2363964', 'cui_str': 'Antiviral treatment'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",2718.0,0.107076,"More users of opioid substitution therapy in the pharmacist-led care group versus the conventional care group agreed to dry blood spot testing (245 [18%] of 1365 vs 145 [11%] of 1353, 2·292, 0·968-5·427, p=0·059); initiated treatment (112 [8%] of 1365 vs 61 [4%] of 1353, 1·889, 1·276-2·789, p=0·0015) and completed treatment (108 [8%] of 1365 vs 58 [4%] of 1353, 1·928, 1·321-2·813, p=0·0007).","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Radley', 'Affiliation': 'NHS Tayside, Directorate of Public Health, Kings Cross Hospital, Dundee, UK; University of Dundee, Ninewells Hospital and Medical School, Dundee, UK. Electronic address: andrew.radley@nhs.net.'}, {'ForeName': 'Marijn', 'Initials': 'M', 'LastName': 'de Bruin', 'Affiliation': 'Radboud University Medical Center, Radboud Institute of Health Sciences, Nijmegen, Netherlands; University of Aberdeen, Institute of Applied Health Sciences, Aberdeen, UK.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Inglis', 'Affiliation': 'University of Dundee, Tayside Clinical Trials Unit, Dundee, UK.'}, {'ForeName': 'Peter T', 'Initials': 'PT', 'LastName': 'Donnan', 'Affiliation': 'University of Dundee, Tayside Clinical Trials Unit, Dundee, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hapca', 'Affiliation': 'University of Dundee, Tayside Clinical Trials Unit, Dundee, UK.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Barclay', 'Affiliation': 'NHS Greater Glasgow and Clyde, Department of Gastroenterology, Glasgow Royal Infirmary, Glasgow, UK; Glasgow Caledonian University, Department of Life Sciences, Glasgow, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fraser', 'Affiliation': 'NHS Grampian, Aberdeen Royal Infirmary, Foresterhill Health Campus, Aberdeen, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Dillon', 'Affiliation': 'University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30120-5']
1185,32532766,Effect of different communication strategies about stopping cancer screening on screening intention and cancer anxiety: a randomised online trial of older adults in Australia.,"OBJECTIVE


To assess different strategies for communicating to older adults about stopping cancer screening.
DESIGN


4 (recommendation statement about stopping screening)×(2; time) online survey-based randomised controlled trial.
SETTING


Australia.
PARTICIPANTS


271 English-speaking participants, aged 65-90, screened for breast/prostate cancer at least once in past decade.
INTERVENTIONS


Time 1: participants read a scenario in which their general practitioner (GP) informed them about the potential benefits and harms of cancer screening, followed by double-blinded randomisation to one of four recommendation statements to stop screening: control ('this screening test would harm you more than benefit you'), health status ('your other health issues should take priority'), life expectancy framed positively ('this test would not help you live longer') and negatively ('you may not live long enough to benefit'). Time 2: in a follow-up scenario, the GP explained why guidelines changed over time (anchoring bias intervention).
MEASURES


Primary outcomes: screening intention and cancer anxiety (10-point scale, higher=greater intention/anxiety), measured at both time points.
SECONDARY OUTCOMES


trust (in their GP, the information provided, the Australian healthcare system), decisional conflict and knowledge of the information presented.
RESULTS


271 participants' responses analysed. No main effects were found. However, screening intention was lower for the negatively framed life expectancy versus health status statement (6.0 vs 7.1, mean difference (MD)=1.1, p=0.049, 95% CI 0.0 to 2.2) in post hoc analyses. Cancer anxiety was lower for the negatively versus positively framed life expectancy statement (4.8 vs 5.8, MD=1.0, p=0.025, 95% CI 0.1 to 1.9). The anchoring bias intervention reduced screening intention (MD=0.8, p=0.044, 95% CI 0.6 to 1.0) and cancer anxiety (MD=0.3, p=0.002, 95% CI 0.1 to 0.4) across all conditions.
CONCLUSION


Older adults may reduce their screening intention without reporting increased cancer anxiety when clinicians use a more confronting strategy communicating they may not live long enough to benefit and add an explicit explanation why the recommendation has changed.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12618001306202; Results).",2020,"The anchoring bias intervention reduced screening intention (MD=0.8, p=0.044, 95% CI 0.6 to 1.0) and cancer anxiety (MD=0.3, p=0.002, 95% CI 0.1 to 0.4) across all conditions.
","['Australia', '271 English-speaking participants, aged 65-90, screened for breast/prostate cancer at least once in past decade', ""271 participants' responses analysed"", 'Older adults', 'older adults in Australia']","['communication strategies about stopping cancer screening', ""stop screening: control ('this screening test would harm you more than benefit you'), health status ('your other health issues should take priority'), life expectancy framed positively""]","['Australian healthcare system), decisional conflict and knowledge of the information presented', 'screening intention and cancer anxiety (10-point scale, higher=greater intention/anxiety', 'screening intention and cancer anxiety', 'screening intention', 'Cancer anxiety', 'cancer anxiety']","[{'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0205394', 'cui_str': 'Other'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}]","[{'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205393', 'cui_str': 'Most'}]",271.0,0.458737,"The anchoring bias intervention reduced screening intention (MD=0.8, p=0.044, 95% CI 0.6 to 1.0) and cancer anxiety (MD=0.3, p=0.002, 95% CI 0.1 to 0.4) across all conditions.
","[{'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachael H', 'Initials': 'RH', 'LastName': 'Dodd', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jolyn', 'Initials': 'J', 'LastName': 'Hersch', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Cvejic', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'McCaffery', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Jansen', 'Affiliation': 'School of Public Health, The University of Sydney, Sydney, New South Wales, Australia jesse.jansen@sydney.edu.au.'}]",BMJ open,['10.1136/bmjopen-2019-034061']
1186,32532767,Does accreditation of general practice promote patient-reported quality of care? A natural cluster randomised experiment.,"OBJECTIVE


To investigate whether accreditation of general practice in Denmark promotes patient-reported quality of care and patient satisfaction.
DESIGN


A national cluster randomised case control study based on an online version of the Danish Patients Evaluate Practice questionnaire. Mixed effects ordered logit regression models taking account of clustering of patients in different municipalities were used in the analyses.
SETTING


General practice in Denmark.
PARTICIPANTS


A representative sample of the Danish population.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcome measure was patient-reported quality of care, and patient satisfaction with general practice and patient satisfaction with the general practitioner served as secondary outcome measures.
RESULTS


In total, 3609 respondents answered the survey. We found no statistically significant relationships between patient-reported quality of care and practice accreditation (2016: OR=0.89, 95% CI 0.73 to 1.07 and 2017: OR=0.85, 95% CI 0.71 to 1.02) and between patient satisfaction with the general practitioner and accreditation (2016: OR=0.93, 95% CI 0.76 to 1.13 and 2017: OR=0.86, 95% CI 0.70 to 1.04). However, there was a statistically significant negative relationship between patient satisfaction with the general practice and recent practice accreditation compared with satisfaction with practices not yet accredited (OR=0.81, 95% CI 0.67 to 0.97) but no significant relationship between patient satisfaction with the general practice and previous accreditation (OR=0.91, 95% CI 0.76 to 1.09).
CONCLUSION


Accreditation does not promote patient-reported quality of care or patient satisfaction. On the contrary, patient satisfaction with the general practice decreases when general practice is recently accredited.",2020,"We found no statistically significant relationships between patient-reported quality of care and practice accreditation (2016: OR=0.89, 95% CI 0.73 to 1.07 and 2017: OR=0.85, 95% CI 0.71 to 1.02) and between patient satisfaction with the general practitioner and accreditation (2016: OR=0.93, 95% CI 0.76 to 1.13 and 2017: OR=0.86, 95% CI 0.70 to 1.04).","['A representative sample of the Danish population', 'General practice in Denmark', '3609 respondents answered the survey']",[],"['quality of care and practice accreditation', 'patient-reported quality of care, and patient satisfaction with general practice and patient satisfaction with the general practitioner served as secondary outcome measures']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],"[{'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0000941', 'cui_str': 'Accreditation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",3609.0,0.158256,"We found no statistically significant relationships between patient-reported quality of care and practice accreditation (2016: OR=0.89, 95% CI 0.73 to 1.07 and 2017: OR=0.85, 95% CI 0.71 to 1.02) and between patient satisfaction with the general practitioner and accreditation (2016: OR=0.93, 95% CI 0.76 to 1.13 and 2017: OR=0.86, 95% CI 0.70 to 1.04).","[{'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Riisgaard', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, University of Southern Denmark, Odense, Denmark hriisgaard@health.sdu.dk.'}, {'ForeName': 'Frans Boch', 'Initials': 'FB', 'LastName': 'Waldorff', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Merethe', 'Initials': 'M', 'LastName': 'Kirstine Andersen', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Line Bjørnskov', 'Initials': 'LB', 'LastName': 'Pedersen', 'Affiliation': 'Department of Public Health, Research Unit for General Practice, University of Southern Denmark, Odense, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-034465']
1187,32532781,Protocol for a two-cohort randomized cluster clinical trial of a motor skills intervention: The Promoting Activity and Trajectories of Health (PATH) Study.,"INTRODUCTION


Data supports that motor skills are an underlying mechanism that influence physical activity along with perceived motor and physical competence, but the relationship between motor skills and physical activity during the early years is unclear. The goal of this study, Promoting Activity and Trajectories of Health (PATH) for Children, is to examine and compare the immediate (pre-test to post-test) and sustained (3-year follow-up) effect of an intervention on motor performance, physical activity and perceived physical competence to a control condition (ie, standard practice) in preschool-age children.
METHODS AND ANALYSIS


The PATH study is a two-cohort, randomised cluster clinical trial. 300 children between the ages of  > 3.5 to 5 years of age will be randomised to the motor skill intervention (n=153) or control (n=147) condition. Each assessment involves a measure of motor skill performance; product and process, seven consecutive days of physical activity monitoring and perceived physical competence. These measures will be assessed before and after the intervention (pre-test to post-test) and then each academic year across 3 years, grades kindergarten, first grade and second grade (3-year follow-up). To assess the clustered longitudinal effect of the intervention on outcome measures, random-effects models (eg, mixed model regression, growth curve modelling and structural equation modelling) will be used. The PATH study addresses gaps in paediatric exercise science research. Findings hold the potential to help shape public health and educational policies and interventions that support healthy development and active living during the early years.
ETHICS AND DISSEMINATION


Ethical approval for this study was obtained through the Health Sciences and Behavioral Sciences Institutional Review Board, University of Michigan (HUM00133319). The PATH study is funded by the National Institutes of Health. Findings will be disseminated via print, online media, dissemination events and practitioner and/or research journals.
TRIAL REGISTRATION NUMBER


NHLBI ClinicalTrials.gov Identifier, NCT03189862. Registered 17 August 2017, https://clinicaltrials.gov/ct2/show/NCT03189862.",2020,300 children between the ages of  > 3.5 to 5 years of age will be randomised to the motor skill intervention (n=153) or control (n=147) condition.,"['Registered 17 August 2017', 'n=153) or control (n=147) condition', 'preschool-age children', '300 children between the ages of  > 3.5 to 5 years of age']","['motor skills intervention', 'motor skill intervention']","['motor performance, physical activity and perceived physical competence']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",300.0,0.0865729,300 children between the ages of  > 3.5 to 5 years of age will be randomised to the motor skill intervention (n=153) or control (n=147) condition.,"[{'ForeName': 'Leah E', 'Initials': 'LE', 'LastName': 'Robinson', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan, USA lerobin@umich.edu.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Colabianchi', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Stodden', 'Affiliation': 'Department of Physical Education, University of South Carolina, Columbia, South Carolina, USA.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Ulrich', 'Affiliation': 'School of Kinesiology, University of Michigan, Ann Arbor, Michigan, USA.'}]",BMJ open,['10.1136/bmjopen-2020-037497']
1188,32540779,Comparison of simple frenotomy with 4-flap Z-frenuloplasty in treatment for ankyloglossia with articulation difficulty: A prospective randomized study.,"OBJECTIVE


To compare the surgical outcomes of simple frenotomy and the 4-flap Z-frenuloplasty according to the articulation test values and tongue-tie classification in patients with ankyloglossia with articulation difficulty.
STUDY DESIGN


prospective randomized study.
SETTING


Tertiary academic center.
SUBJECTS


and methods: Children with ankyloglossia with articulation difficulty were randomly divided into 2 groups for surgical treatment. Patients were evaluated for the tongue-tie classification and articulation test before surgery. Three months after the operation, the frenulum classification and articulation test were re-evaluated to compare the differences in surgical outcome between the two surgical methods.
RESULTS


Out of 37 patients, 19 underwent the 4-flap Z-frenuloplasty and 18, the simple frenotomy. No differences were observed in the baseline characteristics of the patients assigned to both groups. Changes in the tongue-tie classification and improvement in the articulation test results were observed with both the surgical methods. Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups.
CONCLUSION


Although there was no significant difference in the surgical outcome between the two surgical methods, ankyloglossia patients showed improvement in a Korean speech articulation test 3 months after undergoing surgery to release the lingual frenulum.",2020,"Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups.
","['patients with ankyloglossia with articulation difficulty', 'ankyloglossia with articulation difficulty', 'and methods', 'Children with ankyloglossia with articulation difficulty', 'Tertiary academic center', '37 patients, 19 underwent the 4-flap Z-frenuloplasty and 18, the simple frenotomy']","['simple frenotomy and the 4-flap Z-frenuloplasty', 'simple frenotomy with 4-flap Z-frenuloplasty']","['speech articulation test', 'speech outcomes', 'surgical outcome', 'Korean speech articulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152415', 'cui_str': 'Tongue tie'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0192139', 'cui_str': 'Incision of lingual frenum'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0192139', 'cui_str': 'Incision of lingual frenum'}, {'cui': 'C0038925', 'cui_str': 'Flap'}]","[{'cui': 'C0037819', 'cui_str': 'Speech Articulation Tests'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}]",37.0,0.0322658,"Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups.
","[{'ForeName': 'Tae Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Young Chan', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Don', 'Initials': 'SD', 'LastName': 'Yoo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Ah', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Gyu', 'Initials': 'YG', 'LastName': 'Eun', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea. Electronic address: ygeun@khu.ac.kr.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110146']
1189,31816446,Ustekinumab Pharmacokinetics and Exposure Response in a Phase 3 Randomized Trial of Patients With Ulcerative Colitis.,"BACKGROUND & AIMS


The efficacy of antibody-based therapeutics depends on their pharmacokinetics. The pharmacokinetic and exposure response profiles of ustekinumab, a monoclonal antibody against interleukin 12/interleukin 23, are known in patients with Crohn's disease, yet there are few data from patients with ulcerative colitis. We characterized ustekinumab's pharmacokinetics, exposure response, and optimal serum concentrations in patients with ulcerative colitis.
METHODS


We collected data from 2 phase 3 trials (1 induction and 1 maintenance), in which patients with moderate to severe ulcerative colitis received an intravenous induction dose of ustekinumab (130 mg, n = 320; or approximately 6 mg/kg, n = 322). Responders were assigned randomly to groups that received subcutaneous maintenance ustekinumab (90 mg) every 8 weeks (n = 176) or 12 weeks (n = 172), or placebo (n = 175). We evaluated the association between ustekinumab concentration and efficacy, serum based on clinical effects (Mayo score), histologic features, and inflammation (measurement of C-reactive protein, fecal calprotectin, and fecal lactoferrin), as well as safety (infections, serious infections, and serious adverse events), during induction and maintenance therapy. Optimal serum concentrations of ustekinumab were identified using receiver operating characteristic curve analyses.
RESULTS


In patients with ulcerative colitis, dose-proportional serum concentrations of ustekinumab, unaffected by prior biologic or concomitant immunomodulator therapy, reached steady state by the second maintenance dose; the median trough concentration for dosing every 8 weeks was approximately 3-fold that of dosing every 12 weeks. Serum concentrations were associated with clinical and histologic features of efficacy and normalization of inflammation markers. The week-8 concentration threshold for induction of response was 3.7 μg/mL. A steady-state trough serum concentration of 1.3 μg/mL or higher was associated with a higher rate of clinical remission compared with patients who had lower serum concentrations. Serum concentrations of ustekinumab were not associated with infections, serious infections, or serious adverse events.
CONCLUSIONS


In an analysis of data from 2 phase 3 trials of patients with ulcerative colitis, we found that serum concentrations of ustekinumab were proportional to dose, unaffected by prior biologic or concomitant immunomodulator therapies, associated with clinical and histologic efficacy and markers of inflammation, and were not associated with safety events at doses evaluated. Ustekinumab pharmacokinetics are consistent between patients with Crohn's disease vs ulcerative colitis.",2020,"Serum concentrations of ustekinumab were not associated with infections, serious infections, or serious adverse events.
","['patients with ulcerative colitis', ""patients with Crohn's disease vs ulcerative colitis"", ""patients with Crohn's disease"", 'Patients With Ulcerative Colitis', 'patients with moderate to severe ulcerative colitis']","['subcutaneous maintenance ustekinumab', 'intravenous induction dose of ustekinumab', 'placebo']","['Serum concentrations of ustekinumab', 'Serum concentrations', 'rate of clinical remission', 'median trough concentration', 'clinical effects (Mayo score), histologic features, and inflammation (measurement of C-reactive protein, fecal calprotectin, and lactoferrin), as well as safety (infections, serious infections, or serious adverse events', 'serum concentrations of ustekinumab']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0729453,"Serum concentrations of ustekinumab were not associated with infections, serious infections, or serious adverse events.
","[{'ForeName': 'Omoniyi J', 'Initials': 'OJ', 'LastName': 'Adedokun', 'Affiliation': 'Clinical Pharmacology, Janssen Research and Development, LLC, Spring House, Pennsylvania. Electronic address: OAdedoku@its.jnj.com.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Clinical Pharmacology, Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Marano', 'Affiliation': 'Immunology, Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': ""O'Brien"", 'Affiliation': 'Immunology, Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Szapary', 'Affiliation': 'Enterprise R&D, Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Clinical Biostatistics, Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Jewel', 'Initials': 'J', 'LastName': 'Johanns', 'Affiliation': 'Clinical Biostatistics, Janssen Research and Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Rupert W', 'Initials': 'RW', 'LastName': 'Leong', 'Affiliation': 'Gastroenterology, Concord and Macquarie University Hospitals, Sydney, Australia.'}, {'ForeName': 'Tadakazu', 'Initials': 'T', 'LastName': 'Hisamatsu', 'Affiliation': 'Department of Internal Medicine, Kyorin University, Tokyo, Japan.'}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Van Assche', 'Affiliation': 'Clinical and Experimental Medicine, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Danese', 'Affiliation': 'Inflammatory Bowel Disease Clinical and Research Unit, Humanitas Research Hospital, Milano, Italy.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Abreu', 'Affiliation': 'Gastroenterology, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'Gastroenterology, University of California San Diego, La Jolla, California.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2019.11.059']
1190,32683215,Intensive upper extremity training improved whole body movement control for children with unilateral spastic cerebral palsy.,"BACKGROUND


Children with unilateral spastic cerebral palsy (USCP) exhibit impaired bimanual coordination, gait control, and whole body movement control. Intensive upper extremity training has been found to be effective for improving upper extremity function. However, the effectiveness of the intensive upper extremity training on whole body movement control is not known.
RESEARCH QUESTION


The present study aimed to evaluate the effects of Constraint Induced Movement Therapy (CIMT) and Hand Arm Bimanual Intensive Therapy (HABIT) on bimanual coordination and gait control during a complex whole body task.
METHODS


Sixteen children with congenital hemiplegia (age 6-12 years; GMFCS: I-II, MACS: I-II) were randomly assigned to either CIMT or HABIT for 6 h per day training for 15 days. Children were asked to perform two whole body tasks (walking with and without a tray carrying) while 3-D kinematic analysis was performed before and after training.
RESULTS


After training, the HABIT group increased the symmetry in height of their hands during tray carrying (more leveled tray). Both CIMT and HABIT groups decreased the lateral motion of the tray. The CIMT group increased speed and stride length after training in both the walking and tray carrying tasks. Both groups also increased their minimum toe clearance (all p < 0.05).
SIGNIFICANCE


Two types of intensive upper extremity training have provided significant improvements to whole body movement control for children with USCP. Adhering to the specificity of practice concept, HABIT improved bimanual coordination after training during the whole body tray carrying tasks. Given extensive interactions between the upper and lower extremities in real-world activities, future studies should focus on the effects of such combined training.",2020,"Both groups also increased their minimum toe clearance (all p < 0.05).
","['children with unilateral spastic cerebral palsy', 'Children with unilateral spastic cerebral palsy (USCP', 'children with USCP', 'Sixteen children with congenital hemiplegia (age 6-12 years; GMFCS']","['CIMT or HABIT', 'Intensive upper extremity training improved whole body movement control', 'CIMT', 'Constraint Induced Movement Therapy (CIMT) and Hand Arm Bimanual Intensive Therapy (HABIT', 'intensive upper extremity training', 'Intensive upper extremity training']","['bimanual coordination and gait control', 'symmetry in height of their hands', 'speed and stride length', 'lateral motion of the tray', 'minimum toe clearance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0270805', 'cui_str': 'Hemiplegic cerebral palsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0427083', 'cui_str': 'Control of movement'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0184054', 'cui_str': 'Tray'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",16.0,0.0108967,"Both groups also increased their minimum toe clearance (all p < 0.05).
","[{'ForeName': 'Ya-Ching', 'Initials': 'YC', 'LastName': 'Hung', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, 65-30 Kissena Blvd, Flushing, NY 11367, USA. Electronic address: yaching.hung@qc.cuny.edu.'}, {'ForeName': 'Fawzia', 'Initials': 'F', 'LastName': 'Shirzad', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, 65-30 Kissena Blvd, Flushing, NY 11367, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Saleem', 'Affiliation': 'Department of Family, Nutrition, and Exercise Sciences, Queens College, City University of New York, 65-30 Kissena Blvd, Flushing, NY 11367, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Gordon', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, 525 West 120th Street, Box 199, NY 10027, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.009']
1191,32552943,[Efficacy of Small Dose HAG Regimen Combined with Decitabine in Treatment of Elderly Patients with Acute Myeloid Leukemia].,"OBJECTIVE


To study the efficacy of small dose HAG combined with decitabine regimen in the treatment of elderly patients with acute myeloid leukemia (AML).
METHODS


134 elderly AML patients treated in our hospital from March 2015 to December 2018 were selected, and the patients were divided into CAG group and combined treatment group. The AML patients in CAG group was treated with CAG regimen, while the AML patients in combined treatment group was treated with small dose HAG regimen combined with decitabine. Efficacy was evaluated after treatment.
RESULTS


After treatment, the OR rate of the patients in combined treatment group was significantly higher than that in CAG group (χ 2 =5.311, P=0.021). The nausea and vomiting rate, infection rate, myelosuppression rate, bleeding rate and intestinal discomfort rate showed no significant difference between the two groups (P＞0.05). The CD3 + , CD4 +  and CD8 +  levels of patients in combined treatment group were significantly lower than those in CAG group (P＜0.05). The result of followed-up for 2 years, showed that the overall survival rate of patients in combined treatment group was significantly higher than that in CAG group [(76.2±6.3)% vs (45.7±7.6)%] (χ 2 =4.214, P＜0.05), while the disease free survival rate of patients in combined treatment group were (57.4±7.7)%, which was significantly higher than that in CAG group (30.3±7.9)% (χ 2 =5.250, P＜0.05).
CONCLUSION


Small dose HAG regimen combined with decitabine for elderly patients with acute myeloid leukemia has a certain curative efficacy.",2020,"The nausea and vomiting rate, infection rate, myelosuppression rate, bleeding rate and intestinal discomfort rate showed no significant difference between the two groups (P＞0.05).","['134 elderly AML patients treated in our hospital from March 2015 to December 2018', 'Elderly Patients with Acute Myeloid Leukemia', 'elderly patients with acute myeloid leukemia', 'elderly patients with acute myeloid leukemia (AML']","['decitabine', 'CAG', 'HAG combined with decitabine regimen', 'Small Dose HAG Regimen Combined with Decitabine']","['OR rate', 'CD3 + , CD4 +  and CD8 +  levels', 'disease free survival rate', 'overall survival rate', 'Efficacy', 'nausea and vomiting rate, infection rate, myelosuppression rate, bleeding rate and intestinal discomfort rate']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",134.0,0.0202826,"The nausea and vomiting rate, infection rate, myelosuppression rate, bleeding rate and intestinal discomfort rate showed no significant difference between the two groups (P＞0.05).","[{'ForeName': 'Peng-Ji', 'Initials': 'PJ', 'LastName': 'Pan', 'Affiliation': 'Department of Hematology, Yongchuan Hospital of Chongqing Medical University, Chongqing 402160, China.'}, {'ForeName': 'Zhang-Qin', 'Initials': 'ZQ', 'LastName': 'Luo', 'Affiliation': 'Department of Hematology, Yongchuan Hospital of Chongqing Medical University, Chongqing 402160, China,E-mail: luozq056@126.com.'}]",Zhongguo shi yan xue ye xue za zhi,['10.19746/j.cnki.issn.1009-2137.2020.03.018']
1192,32513116,Supporting anticoagulant treatment decision making to optimise stroke prevention in complex patients with atrial fibrillation: a cluster randomised trial.,"BACKGROUND


Anticoagulation for preventing stroke in atrial fibrillation is under-utilised despite evidence supporting its use, resulting in avoidable death and disability. We aimed to evaluate an intervention to improve the uptake of anticoagulation.
METHODS


We carried out a national, cluster randomised controlled trial in the Australian primary health care setting. General practitioners received an educational session, delivered via telephone by a medical peer and provided information about their patients selected either because they were not receiving anticoagulation or for whom anticoagulation was considered challenging. General practitioners were randomised to receive feedback from a medical specialist about the cases (expert decisional support) either before or after completing a post-test audit. The primary outcome was the proportion of patients reported as receiving oral anticoagulation. A secondary outcome assessed antithrombotic treatment as appropriate against guideline recommendations.
RESULTS


One hundred and seventy-nine general practitioners participated in the trial, contributing information about 590 cases. At post-test, 152 general practitioners (84.9%) completed data collection on 497 cases (84.2%). A 4.6% (Adjusted Relative Risk = 1.11, 95% CI = 0.86-1.43) difference in the post-test utilization of anticoagulation between groups was not statistically significant (p = 0.42). Sixty-one percent of patients in both groups received appropriate antithrombotic management according to evidence-based guidelines at post-test (Adjusted Relative Risk = 1.0; 95% CI = 0.85 to 1.19) (p = 0.97).
CONCLUSIONS


Specialist feed-back in addition to an educational session did not increase the uptake of anticoagulation in patients with AF.
TRIAL REGISTRATION


ANZCTRN12611000076976 Retrospectively registered.",2020,"A 4.6% (Adjusted Relative Risk = 1.11, 95% CI = 0.86-1.43) difference in the post-test utilization of anticoagulation between groups was not statistically significant (p = 0.42).","['Australian primary health care setting', 'General practitioners', 'complex patients with atrial fibrillation', 'One hundred and\xa0seventy-nine general practitioners participated in the trial, contributing information about 590 cases', 'patients with AF']","['educational session, delivered via telephone by a medical peer and provided information about their patients selected either because they were not receiving anticoagulation']","['proportion of patients reported as receiving oral anticoagulation', 'uptake of anticoagulation']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C5191356', 'cui_str': '590'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]",,0.336073,"A 4.6% (Adjusted Relative Risk = 1.11, 95% CI = 0.86-1.43) difference in the post-test utilization of anticoagulation between groups was not statistically significant (p = 0.42).","[{'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Gattellari', 'Affiliation': 'Department of Neurology, Institute for Clinical Neurosciences, Neuroscience Research, Royal Prince Alfred Hospital, Missenden Road, Sydney Local Health District, Camperdown (Sydney), New South Wales, 2050, Australia. melina.gattellari@health.nsw.gov.au.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hayen', 'Affiliation': 'Faculty of Health, University of Technology Sydney, 15 Broadway, Ultimo, New South Wales, 2007, Australia.'}, {'ForeName': 'Dominic Y C', 'Initials': 'DYC', 'LastName': 'Leung', 'Affiliation': 'South Western Sydney Clinical School UNSW, Liverpool, Australia.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Zwar', 'Affiliation': 'Faculty of Health, Sciences and Medicine, Bond University, 14 University Drive, Robina, Queensland, 4226, Australia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Worthington', 'Affiliation': 'Department of Neurology, Institute for Clinical Neurosciences, Neuroscience Research, Royal Prince Alfred Hospital, Missenden Road, Sydney Local Health District, Camperdown (Sydney), New South Wales, 2050, Australia.'}]",BMC family practice,['10.1186/s12875-020-01175-0']
1193,32513785,Biomarker Modulation Study of Celecoxib for Chemoprevention in Women at Increased Risk for Breast Cancer: A Phase II Pilot Study.,"In preclinical studies, celecoxib has been associated with reduced risk of breast cancer. In this study, the aim was to assess the biomodulatory effect of celecoxib on blood and benign breast tissue biomarkers in women at increased risk for breast cancer. Women at increased risk for breast cancer [5-year Gail risk score of >1.67%, history of atypical hyperplasia, lobular carcinoma  in situ , or previous estrogen receptor (ER)-negative breast cancer] were treated with celecoxib at 400 mg orally twice daily for 6 months. Participants underwent random periareolar fine needle aspiration and blood draw at baseline and at 6 months for analysis of biomarkers: serum levels of insulin-like growth factor 1 (IGF-1), IGF-binding protein 1 (IGFBP-1), and IGFBP-3; tissue expression of Ki-67 and ER; as well as cytology. Forty-nine patients were eligible for analysis. Median IGFBP-1 levels increased significantly from 6.05 ng/mL at baseline to 6.93 ng/mL at 6 months ( P  = 0.04), and median IGFBP-3 levels decreased significantly from 3,593 ng/mL to 3,420 ng/mL ( P  = 0.01). We also detected favorable changes in cytology of 52% of tested sites after 6 months of celecoxib therapy. No changes in tissue Ki-67 and ER expression levels were observed. No grade 3 or 4 toxicity was recorded. Celecoxib was well tolerated and induced favorable changes in serum biomarkers as well as cytology in this pilot phase II trial. A phase IIb placebo-controlled study with celecoxib could be considered for women at increased risk for breast cancer.",2020,Celecoxib was well tolerated and induced favorable changes in serum biomarkers as well as cytology in this pilot phase II trial.,"['Women at increased risk for breast cancer (5-year Gail risk score of >1.67%, history of atypical hyperplasia, lobular carcinoma in situ, or previous ER-negative breast cancer', 'IN WOMEN AT INCREASED RISK FOR BREAST CANCER', 'Forty-nine patients were eligible for analysis', 'women at increased risk for breast cancer']","['celecoxib', 'Celecoxib', 'placebo']","['insulin-like growth factor 1 (IGF-1), IGF-binding protein 1 (IGFBP-1), and IGFBP-3; tissue expression of Ki-67 and ER', 'tissue Ki-67 and ER expression levels', 'tolerated', 'grade 3 or 4 toxicity', 'Median IGFBP-1 levels', 'median IGFBP-3 levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4517511', 'cui_str': '1.67'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0333977', 'cui_str': 'Atypical hyperplasia'}, {'cui': 'C0279563', 'cui_str': 'Lobular carcinoma in situ of breast'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0071189', 'cui_str': 'IGFBP1 protein, human'}, {'cui': 'C0123707', 'cui_str': 'Insulin-like growth factor binding protein 3'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",49.0,0.0559728,Celecoxib was well tolerated and induced favorable changes in serum biomarkers as well as cytology in this pilot phase II trial.,"[{'ForeName': 'Soley', 'Initials': 'S', 'LastName': 'Bayraktar', 'Affiliation': 'Division of Medical Oncology and Hematology, Department of Medicine, Biruni University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Baghaki', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Liu', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Angelica M', 'Initials': 'AM', 'LastName': 'Gutierrez-Barrera', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Therese B', 'Initials': 'TB', 'LastName': 'Bevers', 'Affiliation': 'Department of Clinical Cancer Prevention, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Valero', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Nour', 'Initials': 'N', 'LastName': 'Sneige', 'Affiliation': 'Department of Cytopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Banu K', 'Initials': 'BK', 'LastName': 'Arun', 'Affiliation': 'Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. barun@mdanderson.org.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0095']
1194,32517492,Intraoperative Effect of 2D vs 3D Fluoroscopy on Quality of Reduction and Patient-Related Outcome in Calcaneal Fracture Surgery.,"BACKGROUND


Three-dimensional (3D) fluoroscopy is thought to be advantageous in the open reduction and internal fixation (ORIF) of calcaneal fractures. The goal of this multicenter randomized controlled trial was to investigate the clinical effect of additional intraoperative 3D fluoroscopy on postoperative quality of reduction and fixation and patient-reported outcome as compared to conventional 2-dimensional (2D) fluoroscopy in patients with intra-articular fractures of the calcaneus.
METHODS


Patients were randomized to 3D or conventional 2D fluoroscopy during operative treatment of calcaneal fractures. Primary outcome was the difference in quality of fracture reduction and implant position on postoperative computed tomography (CT). Secondary endpoints included intraoperative corrections (prior to wound closure), complications, and revision surgery (after wound closure). Function and patient-reported outcome were evaluated after surgery and included range of motion, Foot and Ankle Outcome Score (FAOS), American Orthopaedic Foot & Ankle Society (AOFAS) score, Short-Form 36 (SF-36) questionnaires, and Kellgren-Lawrence posttraumatic osteoarthritis classification. A total of 102 calcaneal fractures were included in the study in 100 patients. Fifty fractures were randomized to the 3D group and 52 to the 2D group.
RESULTS


There was a statistically significant difference in duration of surgery between the groups (2D 125 min vs 3D 147 min;  P  < .001). After 3D fluoroscopy, a total of 57 intraoperative corrections were performed in 28 patients (56%). The postoperative CT scan revealed an indication for additional revision of reduction or implant position in 69% of the 3D group vs 60% in the 2D fluoroscopy group. At 2 years, there was no difference in number of revision surgery, complications, FAOS, AOFAS score, SF-36 score, or posttraumatic osteoarthritis.
CONCLUSION


The use of intraoperative 3D fluoroscopy in the treatment of intra-articular calcaneal fractures prolongs the operative procedures without improving the quality of reduction and fixation. There was no benefit of intraoperative 3D fluoroscopy with regard to postoperative complications, quality of life, functional outcome, or posttraumatic osteoarthritis. Level of Evidence:  Level I, prospective randomized controlled study.",2020,"There was no benefit of intraoperative 3D fluoroscopy with regard to postoperative complications, quality of life, functional outcome, or posttraumatic osteoarthritis.  ","['patients with intra-articular fractures of the calcaneus', 'Calcaneal Fracture Surgery', '102 calcaneal fractures were included in the study in 100 patients', 'Fifty fractures were randomized to the 3D group and 52 to the 2D group', 'Patients']","['conventional 2-dimensional (2D) fluoroscopy', 'conventional 2D fluoroscopy', 'intraoperative 3D fluoroscopy', '2D vs 3D Fluoroscopy', 'additional intraoperative 3D fluoroscopy']","['postoperative CT scan', 'number of revision surgery, complications, FAOS, AOFAS score, SF-36 score, or posttraumatic osteoarthritis', 'postoperative complications, quality of life, functional outcome, or posttraumatic osteoarthritis', 'additional revision of reduction or implant position', 'duration of surgery', 'quality of fracture reduction and implant position on postoperative computed tomography (CT', 'quality of reduction and fixation', 'range of motion, Foot and Ankle Outcome Score (FAOS), American Orthopaedic Foot & Ankle Society (AOFAS) score, Short-Form 36 (SF-36) questionnaires, and Kellgren-Lawrence posttraumatic osteoarthritis classification', 'intraoperative 3D fluoroscopy', 'Quality of Reduction and Patient-Related Outcome', 'intraoperative corrections (prior to wound closure), complications, and revision surgery (after wound closure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332715', 'cui_str': 'Fracture, intra-articular'}, {'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0016641', 'cui_str': 'Fixation of fracture'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}]",50.0,0.0919927,"There was no benefit of intraoperative 3D fluoroscopy with regard to postoperative complications, quality of life, functional outcome, or posttraumatic osteoarthritis.  ","[{'ForeName': 'Jens A', 'Initials': 'JA', 'LastName': 'Halm', 'Affiliation': 'Trauma Unit, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'M Suzan H', 'Initials': 'MSH', 'LastName': 'Beerekamp', 'Affiliation': 'Trauma Unit, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Robert Jan', 'Initials': 'RJ', 'LastName': 'de Muinck-Keijzer', 'Affiliation': 'Trauma Unit, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Ludo F M', 'Initials': 'LFM', 'LastName': 'Beenen', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Maas', 'Affiliation': 'Department of Radiology, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'J Carel', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Schepers', 'Affiliation': 'Trauma Unit, Amsterdam University Medical Centers, Location AMC, Amsterdam, The Netherlands.'}]",Foot & ankle international,['10.1177/1071100720926111']
1195,32520897,"Dynamic impact of transfusion ratios on outcomes in severely injured patients: Targeted machine learning analysis of the Pragmatic, Randomized Optimal Platelet and Plasma Ratios randomized clinical trial.","BACKGROUND


Massive transfusion protocols to treat postinjury hemorrhage are based on predefined blood product transfusion ratios followed by goal-directed transfusion based on patient's clinical evolution. However, it remains unclear how these transfusion ratios impact patient outcomes over time from injury.
METHODS


The Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) is a phase 3, randomized controlled trial, across 12 Level I trauma centers in North America. From 2012 to 2013, 680 severely injured patients required massive transfusion. We used semiparametric machine learning techniques and causal inference methods to augment the intent-to-treat analysis of PROPPR, estimating the dynamic relationship between transfusion ratios and outcomes: mortality and hemostasis at different timepoints during the first 24 hours after admission.
RESULTS


In the intention-to-treat analysis, the 1:1:1 group tended to have decreased mortality, but with no statistical significance. For patients in whom hemostasis took longer than 2 hours, the 1:1:1 ratio was associated with a higher probability of hemostasis, statistically significant from the 4 hour on. In the per-protocol, actual-transfusion-ratios-received analysis, during four successive time intervals, no significant association was found between the actual ratios and mortality. When comparing patient groups who received both high plasma/PRBC and high platelet/PRBC ratios to the group of low ratios in both, the relative risk of achieving hemostasis was 2.49 (95% confidence interval, 1.19-5.22) during the third hour after admission, suggesting a significant beneficial impact of higher transfusion ratios of plasma and platelets on hemostasis.
CONCLUSION


Our results suggest that the impact of transfusion ratios on hemostasis is dynamic. Overall, the transfusion ratios had no significant impact on mortality over time. However, receiving higher ratios of platelets and plasma relative to red blood cells hastens hemostasis in subjects who have yet to achieve hemostasis within 3 hours after hospital admission.
LEVEL OF EVIDENCE


Therapeutic IV.",2020,"Overall, the transfusion ratios had no significant impact on mortality over time.","['680 severely injured patients required massive transfusion', 'Severely Injured Patients', '12 level-I trauma centers in North America']",['Transfusion Ratios'],"['relative risk of achieving hemostasis', 'mortality', 'probability of hemostasis', 'actual ratios and mortality']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0028405', 'cui_str': 'North America'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",680.0,0.326126,"Overall, the transfusion ratios had no significant impact on mortality over time.","[{'ForeName': 'Minh', 'Initials': 'M', 'LastName': 'Nguyen', 'Affiliation': 'From the Division of Epidemiology and Biostatistics (M.N., J.C., A.H.), School of Public Health, University of California, Berkeley; Department of Anesthesia and Perioperative Care (R.P.), Department of Surgery (L.Z.K., R.C.), School of Medicine, University of California, San Francisco, California; Division of Acute Care Surgery, Department of Surgery (E.E.F.), Medical School, Center for Translational Injury Research, Department of Surgery (C.E.W., J.B.H.), Center for Translational Injury Research, Medical School, University of Texas Health Science Center, Houston, Texas; Division of Trauma, Critical Care and Acute Care Surgery, School of Medicine (M.S.), Oregon Health & Science University, Portland, Oregon; and Department of Surgery, School of Medicine (M.C.), University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Pirracchio', 'Affiliation': ''}, {'ForeName': 'Lucy Z', 'Initials': 'LZ', 'LastName': 'Kornblith', 'Affiliation': ''}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Callcut', 'Affiliation': ''}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Wade', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schreiber', 'Affiliation': ''}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Holcomb', 'Affiliation': ''}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Coyle', 'Affiliation': ''}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Hubbard', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002819']
1196,32521871,Analysis of efficacy and prognosis of Osimertinib combined with docetaxel for non-small cell lung cancer.,"PURPOSE


To explore the therapeutic effects and prognosis of osimertinib combined with docetaxel for non-small cell lung cancer (NSCLC).
METHODS


A total of 94 patients with NSCLC diagnosed in hospitals of Changzhou were selected and randomly divided into two groups of 47 patients each. Patients in the control group took osimertinib tablets, while patients in the drug combination group were given intravenous docetaxel in addition to the oral administration of osimertinib. The therapeutic effects, inflammatory factors, toxic and side effects and factors affecting prognosis were analyzed in the two groups.
RESULTS


The overall response rate (RR) and disease control rate (DCR) in the drug combination group were 25.53% and 57.44%, respectively, which were higher than those in the control group. Before treatment, there were no obvious differences in terms of the levels of vascular endothelial growth factor (VEGF), matrix metallopeptidase-9 (MMP-9) and cytokeratin19 fragment antigen 21-1 (CYFRA21-1) between the two groups of patients. After treatment, the levels of the above indicators were lower in the drug combination group than in the control group. Patients in the two groups demonstrated significantly different degrees of side effects during treatment, including fatigue, thrombocytopenia and neutropenia. Smoking history, Karnofsky performance scale (KPS) score and TNM staging were important indicators affecting the prognosis of NSCLC patients. KPS score <70 and TNM stage IV were independent risk factors for the prognosis of NSCLC patients. After follow-up for 2 years, it was found that the survival rate was remarkably different between the two groups. The survival rate was notably higher in the drug combination group than in the control group.
CONCLUSIONS


The therapeutic effect of osimertinib combined with docetaxel is better than that of osimertinib alone, but the toxic and side effects of combined use are significantly higher, suggesting that enteral administration should be conducted during the medication period. Patients with smoking history, advanced TNM stage and high KPS score tend to have a poor prognosis.",2020,"Before treatment, there were no obvious differences in terms of the levels of vascular endothelial growth factor (VEGF), matrix metallopeptidase-9 (MMP-9) and cytokeratin19 fragment antigen 21-1 (CYFRA21-1) between the two groups of patients.","['non-small cell lung cancer (NSCLC', 'Patients with smoking history, advanced TNM stage and high KPS score', 'non-small cell lung cancer', '94 patients with NSCLC diagnosed in the oncology department of our hospital were selected and randomly divided into two groups of 47 patients each']","['Osimertinib combined with docetaxel', 'docetaxel', 'intravenous docetaxel', 'osimertinib combined with docetaxel', 'osimertinib tablets']","['overall response rate (RR) and disease control rate (DCR', 'therapeutic effects, inflammatory factors, toxic and side effects and factors affecting prognosis', 'levels of the above indicators', 'fatigue, thrombocytopenia and neutropenia', 'Smoking history, Karnofsky performance scale (KPS) score and TNM staging', 'survival rate', 'levels of vascular endothelial growth factor (VEGF), matrix metallopeptidase-9 (MMP-9) and cytokeratin19 fragment antigen 21-1 (CYFRA21-1', 'side effects']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0039694', 'cui_str': 'Tetranitromethane'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C1457900', 'cui_str': 'Each'}]","[{'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1515169', 'cui_str': 'TNM Staging System'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C2736430', 'cui_str': 'Matrix metallopeptidase 9'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}]",94.0,0.0450507,"Before treatment, there were no obvious differences in terms of the levels of vascular endothelial growth factor (VEGF), matrix metallopeptidase-9 (MMP-9) and cytokeratin19 fragment antigen 21-1 (CYFRA21-1) between the two groups of patients.","[{'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Pulmonary and Critical Care Medicine, the affiliated Changzhou No.2 People's Hospital of Nanjing Medical University, Changzhou, Jiangsu 213003, China.""}, {'ForeName': 'Yujia', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': ''}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[]
1197,32522591,Mothers' DASH diet adherence and food purchases after week-long episodic future thinking intervention.,"Prospection has helped participants forego the temptation to buy and eat higher calorie nutrient poor foods in favor of buying and eating fewer calories and healthier macronutrient profiles in laboratory tasks and brief field studies. This pilot study examines whether episodic future thinking (EFT) improves mothers' dietary behavior and food purchasing over a longer 7-10-day period. The study utilized a 2 × 2 factorial design with mothers (N = 60) randomized to EFT or standardized episodic thinking (SET) crossed with dietary approaches to stop hypertension (DASH) diet education or a food safety education control. Participants listened to their cues (e.g., recordings of themselves imagining a future event or recalling a past episode) using a mobile ecological momentary intervention (EMI) tool and returned to complete a follow-up dietary recall and submit food receipts. Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group. When considering food purchases for the family, there was an EFT effect on milligrams of sodium purchased (η p 2  = 0.07, p < .05) and a trend towards a decrease in grams of fat purchased (η p 2  = 0.06, p = .06), however, these findings were no longer significant after correcting for multiple comparisons. There were no DASH education effects and no DASH by EFT interactions observed. The dietary intake and food purchasing results should be replicated in larger more representative samples.",2020,"Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group.",['2\u202f×\u202f2 factorial design with mothers (N\u202f=\u202f60) randomized to'],"['episodic future thinking (EFT', 'EFT or standardized episodic thinking (SET) crossed with dietary approaches to stop hypertension (DASH) diet education or a food safety education control', 'mobile ecological momentary intervention (EMI) tool and returned to complete a follow-up dietary recall and submit food receipts']","['DASH education effects', ""mothers' dietary behavior and food purchasing"", 'grams of fat purchased']","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C1456535', 'cui_str': 'Food Safety'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",60.0,0.0401892,"Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group.","[{'ForeName': 'Kelseanna', 'Initials': 'K', 'LastName': 'Hollis-Hansen', 'Affiliation': 'Department of Population Health, University of Texas at Austin, Dell Medical School, Austin, TX, USA; University of Texas at Austin, Steve Hicks School of Social Work, Austin, TX, USA. Electronic address: kelseanna.hollishansen@austin.utexas.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Seidman', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}]",Appetite,['10.1016/j.appet.2020.104757']
1198,32524424,High efavirenz levels but not neurofilament light plasma levels are associated with poor neurocognitive functioning in asymptomatic HIV patients.,"The aim of this study is to assess the effect of efavirenz exposure on neurocognitive functioning and investigate plasma neurofilament light (Nfl) as a biomarker for neurocognitive damage. Sub-analysis of the ESCAPE-study, a randomised controlled trial where virologically suppressed, cognitively asymptomatic HIV patients were randomised (2:1) to switch to rilpivirine or continue on efavirenz. At baseline and week 12, patients underwent an extensive neuropsychological assessment (NPA), and serum efavirenz concentration and plasma Nfl levels were measured. Subgroups of elevated (≥ 4.0 mg/L) and therapeutic (0.74 to< 4.0 mg/L) baseline efavirenz concentration were made. Differences between these groups in baseline NPA Z-scores and in delta scores after efavirenz discontinuation were assessed. Nfl level was measured using an ELISA analysis using single molecule array (Simoa) technology. Correlation of plasma NFL with NPA Z-scores was evaluated using a linear mixed model. The elevated group consisted of 6 patients and the therapeutic group of 48. At baseline, the elevated group showed lower composite Z-scores (median - 1.03; IQR 0.87 versus 0.27; 0.79. p 0.02). This effect was also seen on the subdomains verbal (p 0.01), executive functioning (p 0.02), attention (p < 0.01) and speed (p 0.01). In the switch group, the elevated group improved more on composite scores after discontinuing efavirenz (mean 0.58; SD 0.32 versus 0.22; 0.54, p 0.15). No association between plasma Nfl and composite Z-score was found. High efavirenz exposure is associated with worse cognitive functioning compared with patients with therapeutic concentrations. Plasma Nfl is not a suitable biomarker to measure cognitive damage in this group.",2020,"This effect was also seen on the subdomains verbal (p 0.01), executive functioning (p 0.02), attention (p < 0.01) and speed (p 0.01).","['cognitively asymptomatic HIV patients', 'asymptomatic HIV patients']","['efavirenz', 'rilpivirine or continue on efavirenz']","['plasma Nfl and composite Z-score', 'subdomains verbal', 'executive functioning', 'composite scores', 'cognitive functioning', 'extensive neuropsychological assessment (NPA), and serum efavirenz concentration and plasma Nfl levels', 'lower composite Z-scores', 'plasma NFL with NPA Z-scores']","[{'cui': 'C0343751', 'cui_str': 'Asymptomatic human immunodeficiency virus infection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C1566826', 'cui_str': 'Rilpivirine'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",6.0,0.0736464,"This effect was also seen on the subdomains verbal (p 0.01), executive functioning (p 0.02), attention (p < 0.01) and speed (p 0.01).","[{'ForeName': 'Charlotte S', 'Initials': 'CS', 'LastName': 'Hakkers', 'Affiliation': 'Department of Internal Medicine, section Infectious Diseases, University Medical Center (UMC) Utrecht, Utrecht University, PO Box 85500, 3508, GA, Utrecht, the Netherlands. c.s.hakkers@umcutrecht.nl.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Hermans', 'Affiliation': 'Department of Internal Medicine, section Infectious Diseases, University Medical Center (UMC) Utrecht, Utrecht University, PO Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'Erik M', 'Initials': 'EM', 'LastName': 'van Maarseveen', 'Affiliation': 'Division of Laboratory and Pharmacy, Clinical Pharmacy, University Medical Center (UMC) Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Teunissen', 'Affiliation': 'Department of Clinical Chemistry, Amsterdam Neuroscience Neurochemistry laboratory, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Inge M W', 'Initials': 'IMW', 'LastName': 'Verberk', 'Affiliation': 'Department of Clinical Chemistry, Amsterdam Neuroscience Neurochemistry laboratory, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Joop E', 'Initials': 'JE', 'LastName': 'Arends', 'Affiliation': 'Department of Internal Medicine, section Infectious Diseases, University Medical Center (UMC) Utrecht, Utrecht University, PO Box 85500, 3508, GA, Utrecht, the Netherlands.'}, {'ForeName': 'Andy I M', 'Initials': 'AIM', 'LastName': 'Hoepelman', 'Affiliation': 'Department of Internal Medicine, section Infectious Diseases, University Medical Center (UMC) Utrecht, Utrecht University, PO Box 85500, 3508, GA, Utrecht, the Netherlands.'}]",Journal of neurovirology,['10.1007/s13365-020-00860-1']
1199,32525882,"Improved treatment of community-acquired pneumonia through tailored interventions: Results from a controlled, multicentre quality improvement project.","BACKGROUND


Community-acquired pneumonia (CAP) is one of the leading causes of healthcare utilisation and death worldwide. Treatment according to evidence-based clinical guidelines can reduce mortality, antibiotic exposure and length of hospital stay related to CAP.
LOCAL PROBLEM


Several studies, including a pilot study from one of our sites, indicate that physicians show a low grade of guideline adherence when managing patients with CAP.
METHODS


To improve the guideline-based treatment of patients with CAP admitted to hospital, we designed a quality improvement study. Four process indicators were combined in a CAP care bundle: chest X-ray, CURB-65 severity score, lower respiratory tract samples and antibiotics within 8 hours from admission. After a 4-month baseline period, we applied multiple interventions at three hospitals during 8 months. Progression in our process indicators was measured continuously and compared with a control site without interventions. After the 8-month intervention period, we continued with a 4-month follow-up period to assess the sustainability of the improvements.
RESULTS


The care bundle utilisation rate within 8 hours increased from 11% at baseline to 41% in the follow-up period at the intervention sites, whereas it remained below 3% at the control site. The most considerable improvements have been observed regarding documentation of CURB-65 (34% at baseline, 68% at follow-up) and the collection of lower respiratory tract samples (43% at baseline, 63% at follow-up).
CONCLUSION


Our study has demonstrated poor adherence to CAP guidelines at all sites at baseline. After implementing multiple tailored interventions, guideline adherence increased substantially. In conclusion, we recommend that CAP guidelines should be actively adapted in order to be followed in a daily routine.",2020,"The care bundle utilisation rate within 8 hours increased from 11% at baseline to 41% in the follow-up period at the intervention sites, whereas it remained below 3% at the control site.","['patients with CAP admitted to hospital', 'patients with CAP']",[],"['care bundle utilisation rate', 'mortality, antibiotic exposure and length of hospital stay related to CAP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",[],"[{'cui': 'C3658308', 'cui_str': 'Care Bundles'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}]",,0.02297,"The care bundle utilisation rate within 8 hours increased from 11% at baseline to 41% in the follow-up period at the intervention sites, whereas it remained below 3% at the control site.","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Fally', 'Affiliation': 'Department of Internal Medicine, Section for Pulmonary Diseases, Herlev Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'von Plessen', 'Affiliation': 'Unisanté, Lausanne, Switzerland.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Anhøj', 'Affiliation': 'Centre of Diagnostic Investigation, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Benfield', 'Affiliation': 'Department of Infectious Diseases, Amager Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Tarp', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Lise Notander', 'Initials': 'LN', 'LastName': 'Clausen', 'Affiliation': 'Department of Respiratory and Infectious Diseases, Nordsjaellands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Kolte', 'Affiliation': 'Department of Respiratory and Infectious Diseases, Nordsjaellands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Diernaes', 'Affiliation': 'Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Molzen', 'Affiliation': 'Department of Respiratory and Infectious Diseases, Nordsjaellands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Regitze', 'Initials': 'R', 'LastName': 'Seerup', 'Affiliation': 'Department of Infectious Diseases, Amager Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Israelsen', 'Affiliation': 'Department of Infectious Diseases, Amager Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Anne-Marie Blok', 'Initials': 'AB', 'LastName': 'Hellesøe', 'Affiliation': 'Centre of Diagnostic Investigation, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Ravn', 'Affiliation': 'Department of Internal Medicine, Section for Infectious Diseases, Herlev Gentofte Hospital, Hellerup, Denmark.'}]",PloS one,['10.1371/journal.pone.0234308']
1200,32525946,Motion sickness symptoms during jumping exercise on a short-arm centrifuge.,"Artificial gravity elicited through short-arm human centrifugation combined with physical exercise, such as jumping, is promising in maintaining health and performance during space travel. However, motion sickness symptoms could limit the tolerability of the approach. Therefore, we determined the feasibility and tolerability, particularly occurrence of motion sickness symptoms, during reactive jumping exercises on a short-arm centrifuge. In 15 healthy men, we assessed motion sickness induced by jumping exercises during short-arm centrifugation at constant +1Gz or randomized variable +0.5, +0.75, +1, +1.25 and +1.5 Gz along the body axis referenced to center of mass. Jumping in the upright position served as control intervention. Test sessions were conducted on separate days in a randomized and cross-over fashion. All participants tolerated jumping exercises against terrestrial gravity and on the short-arm centrifuge during 1 Gz or variable Gz at the center of mass without disabling motion sickness symptoms. While head movements markedly differed, motion sickness scores were only modestly increased with jumping on the short-arm centrifuge compared with vertical jumps. Our study demonstrates that repetitive jumping exercises are feasible and tolerable during short-arm centrifugation. Since jumping exercises maintain muscle and bone mass, our study enables further development of exercise countermeasures in artificial gravity.",2020,"While head movements markedly differed, motion sickness scores were only modestly increased with jumping on the short-arm centrifuge compared with vertical jumps.",['15 healthy men'],"['repetitive jumping exercises', 'Artificial gravity elicited through short-arm human centrifugation combined with physical exercise']","['feasibility and tolerability, particularly occurrence of motion sickness symptoms', 'motion sickness scores', 'Motion sickness symptoms']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242678', 'cui_str': 'Gravity, Artificial'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0026603', 'cui_str': 'Motion sickness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",15.0,0.0370295,"While head movements markedly differed, motion sickness scores were only modestly increased with jumping on the short-arm centrifuge compared with vertical jumps.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Frett', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'David Andrew', 'Initials': 'DA', 'LastName': 'Green', 'Affiliation': 'Space Medicine Team (HRE-OM), European Astronaut Centre, European Space Agency, Cologne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Arz', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Noppe', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Petrat', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kramer', 'Affiliation': 'Institute for Sport Sciences, University Konstanz, Konstanz, Germany.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Kuemmel', 'Affiliation': 'Institute for Sport Sciences, University Konstanz, Konstanz, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Tegtbur', 'Affiliation': 'Institutes of Sports Medicine, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Jordan', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center, Cologne, Germany.'}]",PloS one,['10.1371/journal.pone.0234361']
1201,32527692,Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial.,"BACKGROUND


In the PREVAIL study, enzalutamide significantly improved clinical outcomes versus placebo in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC).
OBJECTIVE


To evaluate long-term benefits and risks of enzalutamide in the final prespecified PREVAIL analysis.
DESIGN, SETTING, AND PARTICIPANTS


We conducted a final 5-yr survival analysis of PREVAIL in men with chemotherapy-naïve mCRPC from the enzalutamide (n = 689) and placebo (n = 693) arms.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


Predictors of the primary outcome of overall survival were estimated using the Kaplan-Meier method. Long-term adverse events over time were analyzed.
RESULTS AND LIMITATIONS


At the 5-yr data cutoff, 1382 of 1717 (80%) men had died. Enzalutamide reduced the hazard of death by 17% (hazard ratio 0.83; 95% confidence interval [CI] 0.75-0.93; p < 0.001), despite 65%, 54%, and 43% of placebo-treated patients receiving subsequent docetaxel, abiraterone, and enzalutamide, respectively. Median overall survival was 36 mo (95% CI 34-38) in the enzalutamide arm versus 31 mo (95% CI 29-34) in the placebo arm, with a median follow-up of 69 mo. Prognostic modeling showed 5-yr survival rates of 42%, 24%, and 5% for low-, intermediate-, and high-risk groups, respectively. Greater degrees of confirmed prostate-specific antigen declines (≤3 mo) were associated with greater 5-yr survival. A higher incidence of fatal treatment-emergent adverse events was observed with enzalutamide (6.9% vs 3.8%), with an increase in fatal cardiovascular events (1.6% vs 0.4%).
CONCLUSIONS


With >5 yr of follow-up, enzalutamide continued to demonstrate improved survival in patients with mCRPC despite crossover and multiple subsequent effective therapies, balanced against a slightly higher rate of fatal cardiovascular events. PREVAIL is registered on ClinicalTrials.gov as NCT01212991.
PATIENT SUMMARY


We report a maintained long-term survival benefit with enzalutamide and risks with >5 yr of enzalutamide treatment and follow-up in men with metastatic prostate cancer, and identify groups of men with widely different outcomes based on clinical factors.",2020,"Enzalutamide reduced the hazard of death by 17% (hazard ratio 0.83; 95% confidence interval [CI] 0.75-0.93; p < 0.001), despite 65%, 54%, and 43% of placebo-treated patients receiving subsequent docetaxel, abiraterone, and enzalutamide, respectively.","['n\u2009=\u2009693) arms', 'patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC', 'men with chemotherapy-naïve mCRPC from the enzalutamide (n\u2009=\u2009689) and', 'men with metastatic prostate cancer', 'Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer']","['placebo', 'enzalutamide', 'enzalutamide and risks with >5\u2009yr of enzalutamide', 'Enzalutamide']","['5-yr survival', 'Median overall survival', 'hazard of death', 'fatal treatment-emergent adverse events', '5-yr survival rates', 'overall survival', 'survival', 'died', 'rate of fatal cardiovascular events', 'fatal cardiovascular events']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439084', 'cui_str': '>5'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.640042,"Enzalutamide reduced the hazard of death by 17% (hazard ratio 0.83; 95% confidence interval [CI] 0.75-0.93; p < 0.001), despite 65%, 54%, and 43% of placebo-treated patients receiving subsequent docetaxel, abiraterone, and enzalutamide, respectively.","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Armstrong', 'Affiliation': 'Division of Medical Oncology and Urology, Duke Cancer Institute, Duke University, Durham, NC, USA. Electronic address: andrew.armstrong@duke.edu.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lin', 'Affiliation': 'Biostatistics, Pfizer Inc., San Francisco, CA, USA.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Tombal', 'Affiliation': 'Urology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': ""Division of Urology and Urologic Oncology, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Celestia S', 'Initials': 'CS', 'LastName': 'Higano', 'Affiliation': 'Medical Oncology, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Anthony M', 'Initials': 'AM', 'LastName': 'Joshua', 'Affiliation': ""Department of Medical Oncology, Kinghorn Cancer Centre, St Vincent's Hospital, Sydney, New South Wales, Australia.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Parli', 'Affiliation': 'Clinical Development, Pfizer Inc., San Francisco, CA, USA.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Rosbrook', 'Affiliation': 'Biostatistics, Pfizer Inc., San Diego, CA, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'van Os', 'Affiliation': 'Biostatistics, Astellas Pharma Europe BV, Leiden, The Netherlands.'}, {'ForeName': 'Tomasz M', 'Initials': 'TM', 'LastName': 'Beer', 'Affiliation': 'Hematology/Medical Oncology, OHSU Knight Cancer Institute Oregon Health & Science University, Portland, OR, USA.'}]",European urology,['10.1016/j.eururo.2020.04.061']
1202,32531253,The stability of children's salivary peptidome profiles in response to short-term beverage consumption.,"BACKGROUND


Salivary peptidome profiling analysis has advantages of simplicity and non-invasiveness and great potentiality for screening, monitoring or primary diagnosis of diseases, but may be subjected to change against interferences like diet.
METHODS


We conducted a 5-day study to investigate the influence of 3 kinds of beverages (orange juice, sugar-free tea, and sugar-free liquid yoghurt; water as control) on children's salivary peptidome using mass spectrometry techniques.
RESULTS


All the groups shared a relatively stable pattern in heatmaps during the experimental days. Principal component analysis plot presented slight shifts in all the intervention groups between the baseline and intervention period while samples were not distinctly separated by date. The numbers of significantly changed peptides after short-term orange juice and tea intervention were four and three, respectively, while no changes occurred in the yoghurt group and control. Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A.
CONCLUSIONS


Salivary peptidome has its own stability against beverage intervention, confirming the feasibility and validity of using it as a potential reference for the healthy state of the body, with diet habits recorded and considered as a confounder if necessary.",2020,"Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A.
CONCLUSIONS


","[""children's salivary peptidome using mass spectrometry techniques""]","['beverages (orange juice, sugar-free tea, and sugar-free liquid yoghurt; water as control']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0037813', 'cui_str': 'Mass spectrometry measurement'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.020256,"Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A.
CONCLUSIONS


","[{'ForeName': 'Fangqiao', 'Initials': 'F', 'LastName': 'Wei', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Peiyuan', 'Initials': 'P', 'LastName': 'Tong', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Ce', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Central Laboratory, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Shuguo', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China. Electronic address: kqzsg86@bjmu.edu.cn.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.06.018']
1203,32532550,[Effect of ultrasound-guided right stellate ganglion block on perioperative atrial fibrillation in patients undergoing lung lobectomy: a randomized controlled trial].,"OBJECTIVE


To observe the effects of preoperative right stellate ganglion block on perioperative atrial fibrillation in patients undergoing lung lobectomy.
METHODS


Two hundred patients who underwent a scheduled lobectomy were randomly divided into the S and C groups. The S group was injected with 4mL of 0.2% ropivacaine under ultrasound guidance, and the C group did not receive stellate ganglion block. The patients underwent continuous ECG monitoring, and the incidences of atrial fibrillation and other types of arrhythmias were recorded from the start of surgery to 24hours after surgery.
RESULTS


The respective incidences of atrial fibrillation in the S group and the C group were 3% and 10% (p=0.045); other atrial arrhythmias were 20% and 38% (p=0.005); and ventricular arrhythmia were 28% and 39% (p=0.09).
CONCLUSIONS


The results of the study indicated that preoperative right stellate ganglion block can effectively reduce the incidence of intraoperative and postoperative atrial fibrillation.",2020,"The respective incidences of atrial fibrillation in the S group and the C group were 3% and 10% (p=0.045); other atrial arrhythmias were 20% and 38% (p=0.005); and ventricular arrhythmia were 28% and 39% (p=0.09).
","['patients undergoing lung lobectomy', 'Two hundred patients who underwent a scheduled lobectomy']","['ultrasound-guided right stellate ganglion block', 'ropivacaine', 'C group did not receive stellate ganglion block', 'preoperative right stellate ganglion block']","['respective incidences of atrial fibrillation', 'incidences of atrial fibrillation and other types of arrhythmias', 'incidence of intraoperative and postoperative atrial fibrillation', 'ventricular arrhythmia', 'perioperative atrial fibrillation', 'atrial arrhythmias']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0196728', 'cui_str': 'Injection of anesthetic agent into stellate ganglion'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia'}]",200.0,0.0233805,"The respective incidences of atrial fibrillation in the S group and the C group were 3% and 10% (p=0.045); other atrial arrhythmias were 20% and 38% (p=0.005); and ventricular arrhythmia were 28% and 39% (p=0.09).
","[{'ForeName': 'Ru', 'Initials': 'R', 'LastName': 'Ouyang', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Department of Anesthesiology, Nanchang, China.'}, {'ForeName': 'Xinrui', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Nanchang University, Graduate School, Department of Medicine, Nanchang, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Nanchang University, Graduate School, Department of Medicine, Nanchang, China.'}, {'ForeName': 'Qiqi', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Department of Anesthesiology, Nanchang, China.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Nanchang University, Graduate School, Department of Medicine, Nanchang, China.'}, {'ForeName': 'Enjun', 'Initials': 'E', 'LastName': 'Lei', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, Department of Anesthesiology, Nanchang, China. Electronic address: leienjun@126.com.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.03.007']
1204,32538005,[Influence of acupuncture combined with rehabilitation therapy on limb motor function and serum cAMP and cGMP in patients with hemiplegia of cerebral ischemic stroke].,"OBJECTIVE


To evaluate the therapeutic effect of the combined treatment with balance acupuncture therapy and exercise re-learning rehabilitation therapy and the impact on serum cAMP and cGMP in the patients with hemiplegia of cerebral ischemic stroke.
METHODS


A total of 90 patients of hemiplegia of cerebral ischemic stroke were randomized into an observation group and a control group, 45 cases in each one. All of the patients in the two groups received health education, diet guidance, routine symptomatic treatment as well as exercise re-learning rehabilitation therapy. Additionally, in the observation group, balance acupuncture therapy was applied, in which, the acupoints on the  yang  aspect of the human body, on the governor vessel and bladder meridian were adopted in the morning and those on the  yin  aspect of the human body, on the conception vessel and kidney meridian were stimulated in the afternoon. In the control group, the regular acupuncture was given. In the two groups, both acupuncture and rehabilitation therapies were given 5 days a week, 2 week-treatment as one course and totally 2 courses were required. Separately, before and after treatment, the score of Fugl-Meyer assessment (FMA) and the score of Chinese stroke scale (CSS) were recorded, the levels of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP) detected in serum and the clinical therapeutic effect were evaluated in the two groups.
RESULTS


After treatment, FMA score was increased in the patients of either of the groups as compared with that before treatment ( P <0.01) and CSS score decreased as compared with that before treatment ( P <0.01). After treatment, FMA score in the observation group was higher than that in the control group ( P <0.01) and CSS score was lower than the control group ( P <0.01). After treatment, the level of serum cAMP of the patients in either of the groups was increased as compared with that before treatment ( P <0.01) and that of cGMP decreased as compared with that before treatment ( P <0.01). After treatment, the level of cAMP in the observation group was higher than that in the control group ( P <0.01) and that of cGMP was lower than the control group ( P <0.01). The total effective rate was 93.3% (42/45) in the observation group, better than 73.3% (33/45) in the control group ( P <0.01).
CONCLUSION


The balance acupuncture therapy combined with exercise re-learning rehabilitation effectively improves the motor function of the affected limb, relieves injury and regulate the levels of serum cAMP and cGMP in the patients with hemiplegia of ischemic stroke.",2020,"After treatment, FMA score in the observation group was higher than that in the control group ( P <0.01) and CSS score was lower than the control group ( P <0.01).","['patients with hemiplegia of cerebral ischemic stroke', '90 patients of hemiplegia of cerebral ischemic stroke', 'patients with hemiplegia of ischemic stroke']","['health education, diet guidance, routine symptomatic treatment as well as exercise re-learning rehabilitation therapy', 'acupuncture combined with rehabilitation therapy', 'balance acupuncture therapy', 'acupuncture therapy combined with exercise re-learning rehabilitation', 'balance acupuncture therapy and exercise re-learning rehabilitation therapy']","['FMA score', 'level of cAMP', 'total effective rate', 'CSS score', 'score of Fugl-Meyer assessment (FMA) and the score of Chinese stroke scale (CSS', 'levels of cyclic adenosine monophosphate (cAMP) and cyclic guanosine monophosphate (cGMP) detected in serum and the clinical therapeutic effect', 'limb motor function and serum cAMP and cGMP', 'cGMP', 'level of serum cAMP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018338', 'cui_str': 'Cyclic guanosine monophosphate'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",90.0,0.0241574,"After treatment, FMA score in the observation group was higher than that in the control group ( P <0.01) and CSS score was lower than the control group ( P <0.01).","[{'ForeName': 'Fu-Quan', 'Initials': 'FQ', 'LastName': 'Jing', 'Affiliation': 'Department of Acupuncture-Moxibustion and Tuina.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': 'Department of Neurosurgery, First Affiliated Hospital of Xinjiang Medical University, Urumqi 830011, China.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture-Moxibustion and Tuina.'}, {'ForeName': 'Zeng-Liang', 'Initials': 'ZL', 'LastName': 'Wang', 'Affiliation': 'Department of Neurosurgery, First Affiliated Hospital of Xinjiang Medical University, Urumqi 830011, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190613-k0001']
1205,32538006,[Therapeutic effect of nape cluster acupuncture combined with swallowing function training on post-stroke dysphagia].,"OBJECTIVE


To observe the effect on swallowing function in patients with post-stroke dysphagia treated with nape cluster acupuncture and the immediate effect of acupuncture at Fengchi (GB 20).
METHODS


A total of 60 patients with post-stroke dysphagia were randomized into an observation group and a control group, 30 cases in each one.On the basis of conventional western medication treatment, swallowing function training was applied in the control group, once a day.On the base of the treatment as the control group, nape cluster acupuncture was applied at Fengchi (GB 20), Tianzhu (BL 10), Wangu (GB 12), Lianquan (CV 23), Panglianquan (Extra), Jinjin (EX-HN 12) and Yuye (EX-HN 13) in the observation group, once a day. Additionally, pricking blood was applied at Jinjin (EX-HN 12) and Yuye (EX-HN 13), 2 times a week. The treatment was given 30 min each time, a week as one course and 4 courses were required. Before and after treatment, the standardized swallowing assessment (SSA) score and video fluoroscopic swallowing study (VFSS) score were compared in the two groups. The ultrasonic diagnostic device of swallowing and surface electromyography were used to observe the immediate effect on swallowing related muscles of acupuncture at Fengchi (GB 20).
RESULTS


Compared before treatment, the SSA scores were reduced after treatment in the two groups ( P <0.05), and the change of the observation group was larger than the control group ( P <0.05). Compared before treatment, the VFSS scores were increased after treatment in the two groups ( P <0.05), and the change of the observation group was larger than the control group ( P <0.05). Acupuncture at Fengchi (GB 20) immediately increased the amplitude of submental muscles and infrahyoid muscles in the observation group ( P <0.05), the geniohyoid muscle movement time was reduced and geniohyoid muscle displacement was increased ( P <0.05).
CONCLUSION


On the base of the routine treatment, nape cluster acupuncture could improve swallowing function in patients with post-stroke dysphagia. Acupuncture at Fengchi (GB 20) could immediately affect swallowing related muscles, improve muscle amplitude and reduce swallowing time.",2020,"Compared before treatment, the VFSS scores were increased after treatment in the two groups ( P <0.05), and the change of the observation group was larger than the control group ( P <0.05).","['patients with post-stroke dysphagia treated with nape cluster', 'patients with post-stroke dysphagia', '60 patients with post-stroke dysphagia']","['acupuncture', 'Acupuncture at Fengchi (GB 20', 'acupuncture at Fengchi (GB 20', 'Acupuncture', 'nape cluster acupuncture combined with swallowing function training']","['VFSS scores', 'geniohyoid muscle movement time', 'muscle amplitude and reduce swallowing time', 'swallowing function', 'geniohyoid muscle displacement', 'standardized swallowing assessment (SSA) score and video fluoroscopic swallowing study (VFSS) score', 'amplitude of submental muscles and infrahyoid muscles', 'SSA scores', 'post-stroke dysphagia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0581758', 'cui_str': 'Cervical region back structure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0581758', 'cui_str': 'Cervical region back structure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C3888792', 'cui_str': 'Swallow study'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0224160', 'cui_str': 'Structure of geniohyoid muscle'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0224161', 'cui_str': 'Structure of infrahyoid muscle'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]",60.0,0.0191458,"Compared before treatment, the VFSS scores were increased after treatment in the two groups ( P <0.05), and the change of the observation group was larger than the control group ( P <0.05).","[{'ForeName': 'Jia-Xiu', 'Initials': 'JX', 'LastName': 'Gao', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Liaoning University of TCM, Shenyang 110032, China.'}, {'ForeName': 'Hong-Fei', 'Initials': 'HF', 'LastName': 'Zhou', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Liaoning University of TCM, Shenyang 110032, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190609-k0001']
1206,32538007,[Therapeutic effect of adjuvant treatment of acupuncture in a period of day from 7:00 am to 9:00 am on non-dipper essential hypertension].,"OBJECTIVE


To compare the infuences on circadian rhythm of blood pressure in the patients with non-dipper essential hypertension between the combined treatment of time acupuncture and western medication and the simple western medication.
METHODS


A total of 70 patients with non-dipper essential hypertension were randomized into an acupuncture plus western medication group (35 cases, 2 cases dropped out) and a western medication group (35 cases). In the western medication group, levamlodipine maleate tablets were taken orally, 2.5 mg each time, once daily. In the acupuncture plus western medication group, on the base of the treatment as the western medication group, acupuncture was applied specially in the period of the day from 7:00 am to 9:00 am. The acupoints included Fengchi (GB 20), Zhongwan (CV 12), Tianshu (ST 25), Hegu (LI 4), Quchi (LI 11), Zusanli (ST 36), etc. Acupuncture was given once daily, 5 treatments a week. The duration of treatment in the two groups was 4 weeks. The clinic blood pressure before and after treatment, 24 h ambulatory blood pressure and the levels of serum melatonin (MT) and 5-serotonin (5-HT) were observed in the two groups.
RESULTS


The total effective rate of anti-hypertension was 75.8% (25/33) in the acupuncture plus western medication group, better than 54.3% (19/35) in the western medication group ( P <0.05). The 24 h average systolic blood pressure, the daytime average systolic blood pressure, the daytime average diastolic pressure, and the nighttime average systolic blood pressure were all reduced after treatment in the two groups ( P <0.05). The reduction effect of the aforementioned 4 indexes in the acupuncture plus western medication group was much more obvious as compared with the western medication group ( P <0.05). After treatment, the serum level of MT was increased and 5-HT decreased in the patients of two groups ( P <0.05). The serum level of MT in the acupuncture plus western medication group was higher than that in the western medication group and the level of 5-HT was lower than the western medication group ( P <0.05).
CONCLUSION


Time acupuncture therapy in the period of the day from 7:00 am to 9:00 am, combined with western medication effectively reduce blood pressure and regulate the levels of serum MT and 5-HT so as to maintain the circadian rhythm of blood pressure in patients with non-dipper essential hypertension. The therapeutic effect of this combined treatment is superior to simple western medication.",2020,"The clinic blood pressure before and after treatment, 24 h ambulatory blood pressure and the levels of serum melatonin (MT) and 5-serotonin (5-HT) were observed in the two groups.
","['70 patients with non-dipper essential hypertension', 'patients with non-dipper essential hypertension between the combined treatment of time acupuncture and western medication and the simple western medication', 'patients with non-dipper essential hypertension']","['acupuncture', 'Acupuncture', 'acupuncture plus western medication', 'levamlodipine maleate tablets']","['blood pressure', 'clinic blood pressure', 'ambulatory blood pressure and the levels of serum melatonin (MT) and 5-serotonin (5-HT', 'total effective rate of anti-hypertension', 'serum level of MT', 'level of 5-HT', 'Fengchi (GB 20), Zhongwan (CV 12), Tianshu (ST 25), Hegu (LI 4), Quchi (LI 11), Zusanli (ST 36), etc', '5-HT', 'average systolic blood pressure, the daytime average systolic blood pressure, the daytime average diastolic pressure, and the nighttime average systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0326560', 'cui_str': 'Cinclidae'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205352', 'cui_str': 'Simple'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2717539', 'cui_str': 'levamlodipine'}, {'cui': 'C0024572', 'cui_str': 'Maleates'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1282151', 'cui_str': 'Average systolic blood pressure'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",70.0,0.0176407,"The clinic blood pressure before and after treatment, 24 h ambulatory blood pressure and the levels of serum melatonin (MT) and 5-serotonin (5-HT) were observed in the two groups.
","[{'ForeName': 'Yan-Jun', 'Initials': 'YJ', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Hebei University of CM, Shijiazhuang 050011, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Hebei University of CM, Shijiazhuang 050011, China.'}, {'ForeName': 'Yu-Tong', 'Initials': 'YT', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Hebei University of CM, Shijiazhuang 050011, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Third Department of Cardiovascular Medicine, Shijiazhuang TCM Hospital.'}, {'ForeName': 'Wei-Hua', 'Initials': 'WH', 'LastName': 'Xue', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Hebei University of CM, Shijiazhuang 050011, China.'}, {'ForeName': 'Yan-Hong', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, Affiliated Hospital of Hebei University of CM, Shijiazhuang 050011, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190509-k0006']
1207,32538008,[Prevention effect of transcutaneous electrical acupoint stimulation for chemotherapy-related myelosuppression in non-small cell lung cancer].,"OBJECTIVE


To observe the prevention effect of transcutaneous electrical acupoint stimulation (TEAS) for chemotherapy-related myelosuppression in non-small cell lung cancer.
METHODS


A total of 102 patients with non-small cell lung cancer who received initial chemotherapy were randomly divided into a conventional group, a medication group and a TEAS group, 34 cases in each one. The conventional group was treated with chemotherapy of gemcitabine combined with cisplatin and given routine care. On the basis of conventional group's treatment, the medication group was given  Diyu   Shengbai  tablets before chemotherapy, 2-3 tablets each time, 3 times a day. In the TEAS group, on the basis of conventional group's treatment, TEAS was applied at Dazhui (GV 14), Geshu (BL 17), Hegu (LI 4), Zusanli (ST 36) and Sanyinjiao (SP 6) on day 1, 2, 3, 5, 8, 14, 21 and 28 of chemotherapy. The treatment was given 30 min each time and once a day. In the three groups, the treatment for 28 days was as one course and one course of treatment was required. The changes of leukocytes, platelets, erythrocyte, hemoglobin indexes in patients of the three groups were observed one day before chemotherapy and on day 5, 8, 11, 14, 21 and 28 of chemotherapy. The comfort situation of patients was observed one day before chemotherapy and on the 5th, 11th and 21st day of chemotherapy.
RESULTS


Compared with before chemotherapy, the leukocyte counts of three groups were decreased at various time points after chemotherapy ( P <0.05). Compared with the conventional group, the leukocyte counts were higher on day 8 and 14 in the TEAS group and on day 14 in the medication group ( P <0.05). Compared with before chemotherapy, the platelet count decreased on the day 5, 8, 11 and 14 of chemotherapy in the conventional group ( P <0.05), and the platelet counts all decreased at each time point after chemotherapy in the medication group ( P <0.05). The platelet counts of the TEAS group on day 5, 8, 11 and 14 of chemotherapy were higher than those of the conventional group ( P <0.05), and the platelet counts of the TEAS group on day 5, 8, 11 and 21 of chemotherapy were higher than those of the medication group ( P <0.05). Compared with the conventional group, the comfort situation scores of the TEAS group were higher on the 5th and 11th days of chemotherapy ( P <0.05).
CONCLUSION


Transcutaneous electrical acupoint stimulation can prevent chemotherapy-induced myelosuppression (leukocyte, platelets) in patients with non-small cell lung cancer and improve patient comfort situation.",2020,"Compared with before chemotherapy, the leukocyte counts of three groups were decreased at various time points after chemotherapy ( P <0.05).","['non-small cell lung cancer', 'patients with non-small cell lung cancer', '102 patients with non-small cell lung cancer who received']","['chemotherapy of gemcitabine combined with cisplatin and given routine care', 'TEAS', 'Transcutaneous electrical acupoint stimulation', 'transcutaneous electrical acupoint stimulation', 'initial chemotherapy', 'transcutaneous electrical acupoint stimulation (TEAS']","['platelet count', 'changes of leukocytes, platelets, erythrocyte, hemoglobin indexes', 'leukocyte counts', 'platelet counts', 'comfort situation scores']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",102.0,0.0162421,"Compared with before chemotherapy, the leukocyte counts of three groups were decreased at various time points after chemotherapy ( P <0.05).","[{'ForeName': 'Fang-Chao', 'Initials': 'FC', 'LastName': 'Zhao', 'Affiliation': ""Affiliated Tangshan People's Hospital of North China University of Science and Technology Department of Thoracic Surgery, Tangshan 063000, Hebei Province, China.""}, {'ForeName': 'Cheng-Yuan', 'Initials': 'CY', 'LastName': 'Ye', 'Affiliation': ""Affiliated Tangshan People's Hospital of North China University of Science and Technology Department of Cancer Comprehensive Therapy, Tangshan 063000, Hebei Province, China.""}, {'ForeName': 'Wei-Jian', 'Initials': 'WJ', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedics, Tangshan 063000, Hebei Province, China.'}, {'ForeName': 'Jian-Ming', 'Initials': 'JM', 'LastName': 'Liu', 'Affiliation': ""Affiliated Tangshan People's Hospital of North China University of Science and Technology Department of Thoracic Surgery, Tangshan 063000, Hebei Province, China.""}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190626-k0002']
1208,32554135,The relationship between the tympanostomy tube extrusion time and viscosity.,"OBJECTIVE


The purpose of the study was to assess the correlation between the tympanostomy tube extrusion time and the viscosity of the middle ear fluid.
METHODS


Thirty-three patients who were scheduled for a tympanostomy tube (TT) insertion were included in the study. During the paracentesis procedure, fluid from the middle ear was obtained, and the viscosity was measured with a viscometer. Patients with effusion values below and above the median viscosity value of 439 cP (cP) were assigned to Group 1 and Group 2, respectively. After the surgery, the patients were followed up monthly until the tubes were observed to be extruded.
RESULTS


The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05). The mean tube extrusion time of Group 1 (12.65 ± 4.152 months) was slightly lower than that of Group 2 (13.81 ± 4.43 months); however, the difference was not statistically significant.
CONCLUSION


The tube extrusion time can be longer or shorter and is independent of the effusion viscosity. Further studies are needed to clarify the factors that affect the TT extrusion time.
TRIAL REGISTRATION NUMBER


NCT03848026.",2020,The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05).,"['Patients with effusion values below and above the median viscosity value of 439\xa0cP (cP', 'Thirty-three patients who were scheduled for a tympanostomy tube (TT) insertion were included in the study']",[],"['mean tube extrusion time', 'tube extrusion time and the viscosity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}]",33.0,0.0301946,The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05).,"[{'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Degirmenci', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: ndegirmenci@bezmialem.edu.tr.'}, {'ForeName': 'Selahattin', 'Initials': 'S', 'LastName': 'Tugrul', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: selahattintugrul@yahoo.com.'}, {'ForeName': 'Seda Sezen', 'Initials': 'SS', 'LastName': 'Goktas', 'Affiliation': '75. Yil Boyabat State Hospital, Department of Otorhinolaryngology and Head and Neck Surgery, Sinop, Turkey. Electronic address: sedasezengoktas@gmail.com.'}, {'ForeName': 'Erol', 'Initials': 'E', 'LastName': 'Senturk', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: erolsent@gmail.com.'}, {'ForeName': 'Omer Faruk', 'Initials': 'OF', 'LastName': 'Calim', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: omercalim@yahoo.com.'}, {'ForeName': 'Remzi', 'Initials': 'R', 'LastName': 'Dogan', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: dr.remzidogan@hotmail.com.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Yenigun', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: alperyenigun@gmail.com.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Ozturan', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: orhanent@yahoo.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110140']
1209,32554735,Non-absorbable versus absorbable sutures for anterior colporrhaphy: study protocol for a randomised controlled trial in South Korea.,"INTRODUCTION


The anterior vaginal wall is the segment most commonly affected by prolapse. Traditionally, anterior vaginal wall prolapse is repaired via anterior colporrhaphy, which is known to have a high recurrence rate. Several factors might affect the outcome of anterior colporrhaphy, and the use of absorbable sutures might also be associated with the high recurrence rate because the sutures might not be able to retain adequate strength until the plicated pubocervical fascia remodels and regains maximum tensile strength. Nonetheless, no comparative data exist about the relative efficacy and safety of anterior colporrhaphy using non-absorbable versus absorbable sutures. The objective of this study is to compare the surgical outcomes of anterior colporrhaphy using non-absorbable sutures with those of anterior colporrhaphy using absorbable sutures.
METHODS AND ANALYSIS


This is a randomised, multicentre, superiority trial. Anterior colporrhaphy will be performed in a traditional manner with midline plication of the fibromuscular layer using either non-absorbable or absorbable sutures. The primary outcome is composite surgical success 1 year after surgery defined as the absence of all of the following: (1) anterior vaginal descent beyond the hymen, (2) the presence of vaginal bulge symptoms and (3) retreatment for recurrent anterior vaginal wall prolapse with either surgery or pessary. The secondary outcomes include the individual components of the composite primary end point, anatomical outcomes, condition-specific quality of life and adverse events related to anterior colporrhaphy. The planned number of participants is 192.
ETHICS AND DISSEMINATION


This study was approved by the Institutional Review Board of Seoul National University Hospital (H-1810-037-977). The results of the study will be published in peer-reviewed journals, and the findings will be presented at scientific meetings.
TRIAL REGISTRATION NUMBER


NCT03736811.",2020,"The secondary outcomes include the individual components of the composite primary end point, anatomical outcomes, condition-specific quality of life and adverse events related to anterior colporrhaphy.","['South Korea', 'Seoul National University Hospital (H-1810-037-977']","['absorbable versus absorbable sutures', 'anterior colporrhaphy using non-absorbable sutures', 'Anterior colporrhaphy', 'anterior colporrhaphy using absorbable sutures', 'anterior colporrhaphy using non-absorbable versus absorbable sutures', 'fibromuscular layer using either non-absorbable or absorbable sutures']","['composite surgical success 1\u2009year after surgery defined as the absence of all of the following: (1) anterior vaginal descent beyond the hymen, (2) the presence of vaginal bulge symptoms and (3) retreatment for recurrent anterior vaginal wall prolapse with either surgery or pessary', 'individual components of the composite primary end point, anatomical outcomes, condition-specific quality of life and adverse events related to anterior colporrhaphy']","[{'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0461643', 'cui_str': 'Absorbable suture'}, {'cui': 'C0195224', 'cui_str': 'Anterior colporrhaphy'}, {'cui': 'C0461628', 'cui_str': 'Non-absorbable suture'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0425852', 'cui_str': 'Anterior vaginal wall prolapse'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0195224', 'cui_str': 'Anterior colporrhaphy'}]",,0.129302,"The secondary outcomes include the individual components of the composite primary end point, anatomical outcomes, condition-specific quality of life and adverse events related to anterior colporrhaphy.","[{'ForeName': 'Myung Jae', 'Initials': 'MJ', 'LastName': 'Jeon', 'Affiliation': 'Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, The Republic of Korea jeonmj@snu.ac.kr.'}, {'ForeName': 'Dong Hoon', 'Initials': 'DH', 'LastName': 'Suh', 'Affiliation': 'Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam, The Republic of Korea.'}, {'ForeName': 'Chul Hong', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Obstetrics and Gynecology, Chonnam National University Medical School, Gwangju, The Republic of Korea.'}, {'ForeName': 'Hyun-Hee', 'Initials': 'HH', 'LastName': 'Cho', 'Affiliation': ""Obstetrics and Gynecology, The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul, The Republic of Korea.""}, {'ForeName': 'Jung-Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Obstetrics and Gynecology, Korea University College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Sa Ra', 'Initials': 'SR', 'LastName': 'Lee', 'Affiliation': 'Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, The Republic of Korea.'}, {'ForeName': 'Yong Wook', 'Initials': 'YW', 'LastName': 'Jung', 'Affiliation': 'Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University College of Medicine, Seoul, The Republic of Korea.'}, {'ForeName': 'Soo Rim', 'Initials': 'SR', 'LastName': 'Kim', 'Affiliation': ""Obstetrics and Gynecology, International St. Mary's Hospital, Catholic Kwandong University College of Medicine, Incheon, The Republic of Korea.""}, {'ForeName': 'Mi Kyung', 'Initials': 'MK', 'LastName': 'Kong', 'Affiliation': ""Obstetrics and Gynecology, Institute of Women's Life Medical Science, Yonsei University College of Medicine, Seoul, The Republic of Korea.""}]",BMJ open,['10.1136/bmjopen-2019-034218']
1210,32554736,"Randomised, non-inferiority, controlled procedural outcomes TrIal comParing reverse T And Protrusion versus double-kissing and crush stenting: protocol of the TIP TAP I randomised trial.","INTRODUCTION


To assess the impact of 'reverse T and Protrusion' (TAP) technique on the outcome after stenting of true bifurcation lesions of the left main (LM) or proximal epicardial vessels as compared with double kissing (DK)-crush technique.
METHODS AND ANALYSIS


50 consecutive patients with true coronary bifurcation lesion (Medina 1,1,1 or 0,1,1) of the LM or the proximal main vessels, requiring a two-stent technique as first-line strategy at University Medical Center Mainz, are randomised in a 1:1 ratio to reverse TAP or DK-crush stenting. As recommended by best clinical practice, final angiographic result is evaluated and optical coherence tomographic (OCT) intracoronary imaging is performed to assess and optimise the final result. The primary end point is defined as the percentage of stent expansion in the side branch. Secondary end points consist of angiographic and procedural success (assessed until patient's discharge), procedural parameters (procedural time, fluoroscopy time, use of devices, X-ray dose) and OCT parameters expressing expansion of the stents. Safety parameters include all adverse events up to 6 months after discharge. A clinical, angiographic and intracoronary imaging control at 6 months is planned.
ETHICS AND DISSEMINATION


The protocol complies with good clinical practice and the ethical principles described in the Declaration of Helsinki and is approved by the local ethics committee. The results of the trial will be published as original article(s) in medical journals and/or as presentation at congresses.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03714750).",2020,"To assess the impact of 'reverse T and Protrusion' (TAP) technique on the outcome after stenting of true bifurcation lesions of the left main (LM) or proximal epicardial vessels as compared with double kissing (DK)-crush technique.
","['50 consecutive patients with true coronary bifurcation lesion (Medina 1,1,1 or 0,1,1) of the LM or the proximal main vessels, requiring a two-stent technique as first-line strategy at University Medical Center Mainz']","[""reverse T and Protrusion' (TAP) technique"", 'double kissing (DK)-crush technique', 'T And Protrusion versus double-kissing and crush', 'TAP or DK-crush stenting', 'stenting', 'TIP TAP']","[""angiographic and procedural success (assessed until patient's discharge), procedural parameters (procedural time, fluoroscopy time, use of devices, X-ray dose) and OCT parameters expressing expansion of the stents"", 'percentage of stent expansion in the side branch', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0333056', 'cui_str': 'Protrusion'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0185060', 'cui_str': 'Crushing'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}]","[{'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",50.0,0.186743,"To assess the impact of 'reverse T and Protrusion' (TAP) technique on the outcome after stenting of true bifurcation lesions of the left main (LM) or proximal epicardial vessels as compared with double kissing (DK)-crush technique.
","[{'ForeName': 'Kudrat', 'Initials': 'K', 'LastName': 'Rakhimov', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Buono', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Remzi', 'Initials': 'R', 'LastName': 'Anadol', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ullrich', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Knorr', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ahoopai', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Münzel', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': 'Kardiologie I, Universitätsmedizin Mainz, Mainz, Rheinland-Pfalz, Germany tommaso.gori@unimedizin-mainz.de.'}]",BMJ open,['10.1136/bmjopen-2019-034264']
1211,32554737,Individual breastfeeding support with contingent incentives for low-income mothers in the USA: the 'BOOST (Breastfeeding Onset & Onward with Support Tools)' randomised controlled trial protocol.,"INTRODUCTION


National breastfeeding rates have improved in recent years, however, disparities exist by socioeconomic and psychosocial factors. Suboptimal breastfeeding overburdens the society by increasing healthcare costs. Existing breastfeeding supports including education and peer support have not been sufficient in sustaining breastfeeding rates especially among low-income women. The preliminary outcomes of contingent incentives for breastfeeding in addition to existing support show promising effects in sustaining breastfeeding among mothers in the Special Supplemental Nutrition Programme for women, infants and children (WIC).
METHODS AND ANALYSIS


This trial uses a parallel randomised controlled trial. This trial is conducted at two sites in separate states in the USA. Mothers who were enrolled in WIC and initiated breastfeeding are eligible. Participants (n=168) are randomised into one of the two study groups: (1) standard care control (SC) group consisting of WIC breastfeeding services plus home-based individual support or (2) SC plus breastfeeding incentives (SC +BFI) contingent on demonstrating successful breastfeeding. All participants receive standard breastfeeding services from WIC, home-based individual support and assessments. Participants in SC receive financial compensation based on the number of completed monthly home visits, paid in a lump sum at the end of the 6-month intervention period. Participants in SC +BFI receive an escalating magnitude of financial incentives contingent on observed breastfeeding, paid monthly during the intervention period, as well as bonus incentives for selecting full breastfeeding food packages at WIC. The primary hypothesis is that monthly incentives contingent on breastfeeding in SC +BFI will significantly increase rates of any breastfeeding compared with SC. The primary outcome is the rate of any breastfeeding over 12 months. Randomisation is completed in an automated electronic system. Staff conducting home visits for support and assessments are blinded to study groups.
ETHICS AND DISSEMINATION


The Advarra Institutional Review Board has approved the study protocol (Pro00033168). Findings will be disseminated to our participants, scientific communities, public health officials and any other interested community members.
TRIAL REGISTRATION NUMBER


NCT03964454.",2020,The primary hypothesis is that monthly incentives contingent on breastfeeding in SC +BFI will significantly increase rates of any breastfeeding compared with SC.,"['Mothers who were enrolled in WIC and initiated breastfeeding are eligible', 'Participants (n=168', 'mothers in the Special Supplemental Nutrition Programme for women, infants and children (WIC', 'low-income mothers in the USA']","['standard care control (SC) group consisting of WIC breastfeeding services plus home-based individual support or (2) SC plus breastfeeding incentives (SC +BFI) contingent on demonstrating successful breastfeeding', 'standard breastfeeding services from WIC, home-based individual support and assessments']",['rate of any breastfeeding over 12\u2009months'],"[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.0985776,The primary hypothesis is that monthly incentives contingent on breastfeeding in SC +BFI will significantly increase rates of any breastfeeding compared with SC.,"[{'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Washio', 'Affiliation': 'Substance Use, Gender and Applied Research, RTI International, Research Triangle Park, North Carolina, USA ywashio@rti.org.'}, {'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Collins', 'Affiliation': 'College of Public Health, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hunt-Johnson', 'Affiliation': 'College of Public Health, Temple University, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Zugui', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Value Institute, Christiana Care Health System, Newark, Delaware, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Herrine', 'Affiliation': 'Obstetrics and Gynecology Department, Temple University Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hoffman', 'Affiliation': 'Obstetrics and Gynecology Department, Christiana Care Health System, Newark, Delaware, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kilby', 'Affiliation': 'N.O.R.T.H., Inc-Philadelphia WIC program, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Chapman', 'Affiliation': 'Department of Exercise Science and Athletic Training, Springfield College, Springfield, Massachusetts, USA.'}, {'ForeName': 'Lydia M', 'Initials': 'LM', 'LastName': 'Furman', 'Affiliation': ""Department of Pediatrics, University Hospitals Rainbow Babies and Children's Hospital and Case Western Reserve University School of Medicine, Cleveland, Ohio, USA.""}]",BMJ open,['10.1136/bmjopen-2019-034510']
1212,32554744,Effectiveness of cervical pessary compared to cervical cerclage with or without vaginal progesterone for the prevention of preterm birth in women with twin pregnancies and a short cervix: study protocol for a two-by-two factorial randomised clinical trial.,"INTRODUCTION


Women with twin pregnancies and a short cervix are at increased risk for preterm birth (PTB). Given the burden of prematurity and its attendant risks, the quest for effective interventions in twins has been an area of considerable research. Studies investigating the effectiveness of cervical cerclage, cervical pessary and vaginal progesterone in preventing PTB have yielded conflicting results. The aim of this study is to compare the effectiveness of cervical pessary and cervical cerclage with or without vaginal progesterone to prevent PTB in women with twin pregnancies and a cervical length (CL) ≤ 28 mm.
METHODS AND ANALYSIS


This multicentre, randomised clinical trial will be conducted at My Duc Hospital and My Duc Phu Nhuan Hospital, Vietnam. Asymptomatic women with twin pregnancies and a CL ≤28 mm, measured at 16-22 weeks' gestation, will be randomised in a 1:1:1:1 ratio to receive a cerclage, pessary, cerclage plus progesterone or pessary plus progesterone. Primary outcome will be PTB <34 weeks. Secondary outcomes will be maternal and neonatal complications. We preplanned a subgroup analysis according to CL from all women after randomisation and divided into four quartiles. Analysis will be conducted on an intention-to-treat basis. The rate of PTB <34 weeks' gestation in women with twin pregnancies and a cervix ≤28 mm and treated with pessary in our previous study at My Duc Hospital was 24.2%. A sample size of 340 women will be required to show or refute that cervical cerclage decreases the rate of PTB <34 weeks by 50% compared with pessary (from 24.2% to 12.1%, α level 0.05, power 80%, 5% lost to follow-up and protocol deviation). This study is not to be powered to assess interactions between interventions.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Institutional Ethics Committee of My Duc Hospital and informed patient consent was obtained before study enrolment. Results of the study will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NCT03863613 (date of registration: 4 March 2019).",2020,The rate of PTB <34 weeks' gestation in women with twin pregnancies and a cervix ≤28 mm and treated with pessary in our previous study at My Duc Hospital was 24.2%.,"['Women with twin pregnancies and a short cervix are at increased risk for preterm birth (PTB', 'women with twin pregnancies and a short cervix', ""Asymptomatic women with twin pregnancies and a CL ≤28\u2009mm, measured at 16-22 weeks' gestation"", 'My Duc Hospital and My Duc Phu Nhuan Hospital, Vietnam', '340 women', 'women with twin pregnancies and a cervical length (CL) ≤ 28\u2009mm']","['cerclage, pessary, cerclage plus progesterone or pessary plus progesterone', 'cervical cerclage, cervical pessary and vaginal progesterone', 'cervical pessary', 'cervical pessary and cervical cerclage with or without vaginal progesterone', 'cervical cerclage with or without vaginal progesterone']","['preterm birth', 'maternal and neonatal complications', 'rate of PTB']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C4517730', 'cui_str': '340'}]","[{'cui': 'C1292825', 'cui_str': 'Cerclage'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0195681', 'cui_str': 'Cerclage of uterine cervix'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}]","[{'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",340.0,0.402334,The rate of PTB <34 weeks' gestation in women with twin pregnancies and a cervix ≤28 mm and treated with pessary in our previous study at My Duc Hospital was 24.2%.,"[{'ForeName': 'Vinh Q', 'Initials': 'VQ', 'LastName': 'Dang', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Viet Nam bsvinh.dq@myduchospital.vn.'}, {'ForeName': 'Yen Tn', 'Initials': 'YT', 'LastName': 'He', 'Affiliation': 'HOPE Research Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Ha Nh', 'Initials': 'HN', 'LastName': 'Pham', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Tuyen Tt', 'Initials': 'TT', 'LastName': 'Trieu', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Phu Nhuan Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Trung Q', 'Initials': 'TQ', 'LastName': 'Bui', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Nhu T', 'Initials': 'NT', 'LastName': 'Vuong', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Loc Mt', 'Initials': 'LM', 'LastName': 'Nguyen', 'Affiliation': 'HOPE Research Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Diem Tn', 'Initials': 'DT', 'LastName': 'Nguyen', 'Affiliation': 'HOPE Research Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Thanh V', 'Initials': 'TV', 'LastName': 'Le', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Cam H', 'Initials': 'CH', 'LastName': 'Le', 'Affiliation': 'Department of Obstetrics and Gynecology, My Duc Phu Nhuan Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Ben W', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Lan N', 'Initials': 'LN', 'LastName': 'Vuong', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Medicine and Pharmacy at HCMC, Ho Chi Minh City, Viet Nam.'}]",BMJ open,['10.1136/bmjopen-2019-036587']
1213,32559716,A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women.,"OBJECTIVE


Despite high rates of prenatal insomnia, efficacious treatment options for this population are quite limited. Early evidence from randomized controlled trials (RCTs) support the efficacy of face-to-face cognitive-behavioral therapy for insomnia (CBTI) for prenatal insomnia. Yet, as many patients are unable to access this specialist-driven care, a critical need exists to increase its accessibility. This RCT examined the efficacy internet-based digital CBTI in pregnant women with insomnia.
METHODS


Single-site RCT. A total of 91 pregnant women (29.03 ± 4.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI) were randomized to digital CBTI or digital sleep education control. The ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C) served as study outcomes, which were collected before treatment and after treatment during pregnancy, then six weeks after childbirth.
RESULTS


From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008). Sleep symptoms did not change during pregnancy in the control group. After childbirth, CBTI patients, relative to controls, slept longer by 40 min per night (p = 0.01) and reported better sleep maintenance. No pre or postnatal treatment effects on depression or cognitive arousal were observed.
CONCLUSIONS


Digital CBTI improves sleep quality and sleep duration during pregnancy and after childbirth. To better optimize outcomes, CBTI should be tailored to meet the changing needs of women as the progress through pregnancy and early parenting. NAME: Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression. URL: clinicaltrials.gov. Registration: NCT03596879.",2020,"From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008).","['insomnia (CBTI) for prenatal insomnia', 'pregnant women with insomnia', '91 pregnant women (29.03\xa0±\xa04.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI', 'pregnant women']","['Digital CBTI', 'digital CBTI or digital sleep education control', 'digital cognitive behavioral therapy', 'face-to-face cognitive-behavioral therapy', 'NAME']","['nightly sleep duration', 'PSQI', 'sleep quality and sleep duration', 'sleep maintenance', 'ISI', 'depression or cognitive arousal', ""ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C"", 'Sleep symptoms', 'Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]",91.0,0.126542,"From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA. Electronic address: dkalmba1@hfhs.org.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': ""O'Brien"", 'Affiliation': 'Departments of Obstetrics & Gynecology and Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Swanson', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Roopina', 'Initials': 'R', 'LastName': 'Sangha', 'Affiliation': 'Department of Obstetrics & Gynecology, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Srijan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Big Health Inc, San Francisco, CA, USA; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.016']
1214,32560689,The Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) protocol: a non-randomised controlled trial of personalised care and support planning for persons living with diabetes.,"BACKGROUND


Personalised care and support planning (CSP) has been shown to improve diabetes outcomes, patient experience and provider morale in the care of persons living with diabetes. However, this has not been confirmed in controlled studies. Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) is a pragmatic controlled trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in the public primary care setting in Singapore.
METHODS


Teamlet-empanelled patients with diabetes at four polyclinics are recruited for this study. Participants who attend either of the two Intervention clinics are sent their investigation results in a care planning letter (CPL) to prepare them for the CSP conversation. This conversation is facilitated by a trained CSP practitioner who engages them in discussion of concerns, goals and action plans, and documents their plans for subsequent review. Participants in the two Control clinics will receive standard diabetes care. Participants will complete two or more CSP conversations (Intervention) or regular consultations (Control) at the annual review visits within the 18 months of the study. The sample size is calculated at 1620 participants, with glycated haemoglobin (HbA1c) as the primary outcome measure. Secondary outcome measures include patient activation (as measured by PAM-13) and changes in healthcare utilisation and cost.
DISCUSSION


This study is a pragmatic trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in a real world setting. It promises to provide insights with regard to the implementation of this model of care in Singapore and the region.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier NCT04288362. Retrospectively registered on 28 February 2020.",2020,"Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) is a pragmatic controlled trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in the public primary care setting in Singapore.
","['Participants who attend either of the two Intervention clinics are sent their investigation results in a care planning letter (CPL) to prepare them for the CSP conversation', 'persons living with diabetes in a real world setting', 'persons living with diabetes', 'persons living with diabetes in the public primary care setting in Singapore', 'Participants will complete two or more CSP conversations (Intervention) or regular consultations (Control) at the annual review visits within the 18\u2009months of the study', 'Retrospectively registered on 28 February 2020', 'Teamlet-empanelled patients with diabetes at four polyclinics are recruited for this study']","['personalised care and support planning', 'personalised CSP', 'standard diabetes care', 'Personalised care and support planning (CSP']",['patient activation (as measured by PAM-13) and changes in healthcare utilisation and cost'],"[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2931826', 'cui_str': 'Potassium aggravated myotonia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.0727258,"Patient Activation through Community Empowerment/Engagement for Diabetes Management (PACE-D) is a pragmatic controlled trial that evaluates the effectiveness of personalised CSP in persons living with diabetes in the public primary care setting in Singapore.
","[{'ForeName': 'Wee Hian', 'Initials': 'WH', 'LastName': 'Tan', 'Affiliation': 'National University Polyclinics, National University Health System, Singapore, Singapore. wee_hian_tan@nuhs.edu.sg.'}, {'ForeName': 'Victor Weng Keong', 'Initials': 'VWK', 'LastName': 'Loh', 'Affiliation': 'Division of Family Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Venkataraman', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Shoon Thai', 'Initials': 'ST', 'LastName': 'Choong', 'Affiliation': 'National University Polyclinics, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Yii Jen', 'Initials': 'YJ', 'LastName': 'Lew', 'Affiliation': 'National University Polyclinics, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Sundram', 'Affiliation': 'National University Polyclinics, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Tsou', 'Affiliation': 'National University Polyclinics, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Soon Guan', 'Initials': 'SG', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Gibbons', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Vikki', 'Initials': 'V', 'LastName': 'Entwistle', 'Affiliation': 'Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Young', 'Affiliation': 'Division of Family Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'E Shyong', 'Initials': 'ES', 'LastName': 'Tai', 'Affiliation': 'Division of Endocrinology, University Medicine Cluster, National University Health System, Singapore, Singapore.'}, {'ForeName': 'Tong Wei', 'Initials': 'TW', 'LastName': 'Yew', 'Affiliation': 'Division of Endocrinology, University Medicine Cluster, National University Health System, Singapore, Singapore.'}]",BMC family practice,['10.1186/s12875-020-01173-2']
1215,32562632,Long-term developmental effect of withholding parenteral nutrition in paediatric intensive care units: a 4-year follow-up of the PEPaNIC randomised controlled trial.,"BACKGROUND


The PEPaNIC randomised controlled trial, which recruited 1440 critically ill infants and children in 2012-15, showed that withholding parenteral nutrition for 1 week (late-parenteral nutrition), compared with early supplementation within 24 h of admission to the paediatric intensive care unit (early-parenteral nutrition), prevented infections, accelerated recovery, and improved neurocognitive development assessed 2 years later. Because several neurocognitive domains can only be thoroughly assessed from age 4 years onwards, we aimed to determine the effect of late-parenteral nutrition versus early-parenteral nutrition on physical, neurocognitive, and emotional and behavioural development 4 years after randomisation.
METHODS


This is a preplanned, blinded, 4-year follow-up study of participants included in the PEPaNIC trial (done at University Hospitals Leuven, Belgium; Erasmus Medical Centre Sophia Children's Hospital, Rotterdam, Netherlands; and Stollery Children's Hospital, Edmonton, AB, Canada) and of matched healthy children. Studied outcomes were anthropometrics; health status; parent-reported or caregiver-reported executive functions, and emotional and behavioural problems; and clinical tests for intelligence, visual-motor integration, alertness, motor coordination, and memory. Through multivariable linear and logistic regression analyses, after imputation for missing values (≤30%) and adjustment for risk factors, we investigated the effect of early-parenteral nutrition versus late-parenteral nutrition. This trial is registered with ClinicalTrials.gov, NCT01536275.
FINDINGS


Between March 8, 2016, and Nov 8, 2019, 684 children from the original PEPaNIC trial (356 from the late-parenteral nutrition group and 328 from the early-parenteral nutrition group) were assessed for neurocognitive development at 4-years follow-up. Compared with the control group (369 healthy children), children who had critical illness had lower height (β-estimate -2·11 [95% CI -3·15 to -1·06]; p<0·0001) and head circumference (-0·42 [-0·67 to -0·18]; p=0.00077); and worse health status (eg, hospital admission odds ratio 4·27 [95% CI 3·12 to 5·84]; p<0·0001), neurocognitive (eg, parent-reported or caregiver-reported total executive functioning β-estimate 3·57 [95% CI 1·95 to 5·18], p<0·0001; total intelligence quotient -7·35 [-9·31 to -5·39], p<0·0001), and parent-reported or caregiver-reported emotional and behavioural developmental outcomes (internalising 2·73 [1·19 to 4·28], p=0·00055; externalising 1·63 [0·19 to 3·08], p=0·027; and total behavioural problems 2·95 [1·44 to 4·46], p=0·00013), adjusted for risk factors. Outcomes were never worse in the late-parenteral nutrition group compared with the early-parenteral nutrition group, but patients in the late-parenteral nutrition group had fewer parent-reported or caregiver-reported internalising (β-estimate -1·88 [95% CI -3·69 to -0·07]; p=0·042), externalising (-1·73 [-3·43 to -0·03]; p=0·046), and total emotional and behavioural problems (-2·44 [-4·22 to -0·67]; p=0·0070) than patients who had received early-parenteral nutrition, after adjusting for risk factors, and were no longer different from healthy controls for these outcomes.
INTERPRETATION


Omitting early parenteral nutrition use for critically ill children did not adversely affect long-term outcomes 4 years after randomisation and protected against emotional and behavioural problems, further supporting the deimplementation of early parenteral nutrition.
FUNDING


European Research Council, Methusalem, Flanders Institute for Science and Technology, Research Foundation Flanders, Sophia Foundation, Stichting Agis Zorginnovatie, Erasmus Trustfonds, and the European Society for Clinical Nutrition and Metabolism.",2020,"p=0·00055; externalising 1·63 [0·19 to 3·08], p=0·027; and total behavioural problems 2·95 [1·44 to 4·46], p=0·00013), adjusted for risk factors.","['Between March 8, 2016, and Nov 8, 2019, 684 children from the original PEPaNIC trial (356 from the late-parenteral nutrition group and 328 from the early-parenteral nutrition group', '369 healthy children), children who had critical illness had lower height (β-estimate -2·11', 'paediatric intensive care units', ""participants included in the PEPaNIC trial (done at University Hospitals Leuven, Belgium; Erasmus Medical Centre Sophia Children's Hospital, Rotterdam, Netherlands; and Stollery Children's Hospital, Edmonton, AB, Canada) and of matched healthy children"", '1440 critically ill infants and children in 2012-15, showed that withholding parenteral nutrition for 1 week (late-parenteral nutrition), compared with early supplementation within 24 h of admission to the paediatric intensive care unit (early-parenteral nutrition), prevented infections, accelerated recovery, and improved neurocognitive development assessed 2 years later']","['4·22 to -0·67', '7·35', 'withholding parenteral nutrition']","['neurocognitive development', 'neurocognitive (eg, parent-reported or caregiver-reported total executive functioning β-estimate 3·57', 'anthropometrics; health status; parent-reported or caregiver-reported executive functions, and emotional and behavioural problems; and clinical tests for intelligence, visual-motor integration, alertness, motor coordination, and memory', 'total emotional and behavioural problems (-2·44', 'total intelligence quotient', 'worse health status (eg, hospital admission odds ratio 4·27', 'head circumference (-0·42 [-0·67 to -0·18']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4517576', 'cui_str': '1440'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}]",684.0,0.251002,"p=0·00055; externalising 1·63 [0·19 to 3·08], p=0·027; and total behavioural problems 2·95 [1·44 to 4·46], p=0·00013), adjusted for risk factors.","[{'ForeName': 'An', 'Initials': 'A', 'LastName': 'Jacobs', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Karolijn', 'Initials': 'K', 'LastName': 'Dulfer', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre, Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Renate D', 'Initials': 'RD', 'LastName': 'Eveleens', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre, Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Hordijk', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre, Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Van Cleemput', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Verlinden', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Pieter J', 'Initials': 'PJ', 'LastName': 'Wouters', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Liese', 'Initials': 'L', 'LastName': 'Mebis', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Gonzalo Garcia', 'Initials': 'GG', 'LastName': 'Guerra', 'Affiliation': ""Department of Paediatrics, Intensive Care Unit, University of Alberta, Stollery Children's Hospital, Edmonton, Canada.""}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Joosten', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre, Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Sascha C', 'Initials': 'SC', 'LastName': 'Verbruggen', 'Affiliation': ""Intensive Care Unit, Department of Paediatrics and Paediatric Surgery, Erasmus Medical Centre, Sophia Children's Hospital, Rotterdam, Netherlands.""}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Güiza', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Vanhorebeek', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Van den Berghe', 'Affiliation': 'Clinical Division and Laboratory of Intensive Care Medicine, Department of Cellular and Molecular Medicine, Katholieke Universiteit Leuven, Leuven, Belgium. Electronic address: greet.vandenberghe@kuleuven.be.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30104-8']
1216,32562806,Impact of health warning labels on snack selection: An online experimental study.,"Excessive consumption of energy-dense food increases the risk of obesity, which in turn increases the risk of non-communicable diseases, including heart disease, type 2 diabetes and most non-smoking-related cancers. Health warning labels (HWLs) that communicate the adverse health consequences of excess energy consumption could reduce intake of energy-dense foods. The aim of the current study was to estimate the impact on selection of energy-dense snacks of (a) image-and-text HWLs (b) text-only HWLs and (c) calorie information. In a between-subjects, 3 (HWL: image-and-text, text-only, no label) x 2 (calorie information: present, absent), factorial experimental design, participants (N = 4134) were randomised to view a selection of energy-dense and non-energy-dense snacks with one of five label types or no label. The primary outcome was the proportion of participants selecting an energy-dense snack in a hypothetical vending machine task. The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%). Compared to the no label group, participants were least likely to select an energy-dense snack in the image-and-text HWL group (OR = 0.46, 95%CI = 0.40, 0.54, p < 0.001). Health warning labels - particularly those including an image and text - have the potential to reduce selection of energy-dense snacks in an online setting. Their impact on selection and consumption in real-world settings awaits testing.",2020,"The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%).","['participants (N\u202f=\u202f4,134', 'snack selection']","['energy-dense snacks of (a) image-and-text HWLs (b) text-only HWLs and (c) calorie information', 'health warning labels', 'energy-dense and non-energy-dense snacks with one of five label types or no label']","['proportion of participants selecting an energy-dense snack', 'proportion of participants selecting an energy-dense snack in a hypothetical vending machine task']","[{'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0336779', 'cui_str': 'Machine'}]",4134.0,0.0769476,"The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%).","[{'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Clarke', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK. Electronic address: ncc42@medschl.cam.ac.uk.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pechey', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Mantzari', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Anna K M', 'Initials': 'AKM', 'LastName': 'Blackwell', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'De-Loyde', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Morris', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Hollands', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}]",Appetite,['10.1016/j.appet.2020.104744']
1217,32562807,Minimising COVID-19 exposure during tracheal intubation by using a transparent plastic box: A randomised prospective simulation study.,,2020,,[],[],[],[],[],[],,0.0231458,,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Clariot', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, 94010 Créteil, France; Université Paris Est Créteil, Faculté de Santé, 94010 Créteil, France. Electronic address: simon.clariot@aphp.fr.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Dumain', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, 94010 Créteil, France.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Gauci', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, 94010 Créteil, France; Université Paris Est Créteil, Faculté de Santé, 94010 Créteil, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Langeron', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, 94010 Créteil, France; Université Paris Est Créteil, Faculté de Santé, 94010 Créteil, France; Experimental Neuropathology Unit, Institut Pasteur, 75015 Paris, France.""}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Levesque', 'Affiliation': ""Service d'anesthésie-réanimation chirurgicale, DMU CARE, DHU A-TVB, Assistance publique Hôpitaux de Paris (AP-HP), Hôpitaux Universitaires Henri Mondor, 94010 Créteil, France; Université Paris Est Créteil, Faculté de Santé, 94010 Créteil, France; EA DYNAMYC Université Paris-Est Créteil (UPEC), École Nationale Vétérinaire d'Alfort (ENVA), Faculté de Santé de Créteil, 8, rue du Général Sarrail, 94010 Créteil, France.""}]","Anaesthesia, critical care & pain medicine",['10.1016/j.accpm.2020.06.005']
1218,32562889,Including Ratio of Platelets to Liver Stiffness Improves Accuracy of Screening for Esophageal Varices That Require Treatment.,"BACKGROUND & AIMS


Based on platelets and liver stiffness measurements, the Baveno VI criteria (B6C), the expanded B6C (EB6C), and the ANTICIPATE score can be used to rule out varices needing treatment (VNT) in patients with compensated chronic liver disease. We aimed to improve these tests by including data on the ratio of platelets to liver stiffness.
METHODS


In a retrospective analysis of data from 10 study populations, collected from 2004 through 2018, we randomly assigned data from 2368 patients with chronic liver disease of different etiologies to a derivation population (n = 1579; 15.1% with VNT, 50.2% with viral hepatitis, 28.9% with nonalcoholic fatty liver disease, 28.9% with alcohol-associated liver disease, 20.8% with model for end-stage liver disease scores of 9.5 ± 3.0, and 93.0% with liver stiffness measurements ≥10 kPa) or a validation population (n = 789). Test results were compared with results from a sequential algorithm (VariScreen). VariScreen incorporated data on platelets or liver stiffness measurements and then the ratio of platelets to liver stiffness measurement, adjusted for etiology, patient sex, and international normalized ratio.
RESULTS


In the derivation population, endoscopies were spared for 23.9% of patients using the B6C (VNT missed in 2.9%), 24.3% of patients using the ANTICIPATE score (VNT missed in 4.6%), 34.5% of patients using VariScreen (VNT missed in 2.9%), and 41.9% of patients using the EB6C (VNT missed in 10.9%). Differences in spared endoscopy rates were significant (P ≤ .001), except for B6C vs ANTICIPATE and in missed VNT only for EB6C vs the others (P ≤ .009). VariScreen was the only safe test regardless of sex or etiology (missed VNT, ≤5%). Moreover, VariScreen secured screening without missed VNT in patients with model for end-stage liver disease scores higher than 10. This overall strategy performed better than a selective strategy restricted to patients with compensated liver disease. Test performance and safety did not differ significantly among populations.
CONCLUSIONS


In a retrospective study of data from 2368 patients with chronic liver disease, we found that the B6C are safe whereas the EB6C are unsafe, based on missed VNT. The VariScreen algorithm performed well in patients with chronic liver disease of any etiology or severity-it is the only test that safely rules out VNT and can be used in clinical practice.",2020,Differences in spared endoscopy rates were significant (P≤.001) except for B6C vs ANTICIPATE and in missed VNT only for EB6C vs the others (P≤.009).,"['Esophageal Varices', 'patients with chronic liver disease of any etiology or severity', '10 study populations, collected from 2004 through 2018, we randomly assigned data from 2368 patients with chronic liver disease of different etiologies to a derivation population (n=1579; 15.1% with VNT, 50.2% with viral hepatitis, 28.9% with nonalcoholic fatty liver disease, 28.9% with alcohol-associated liver disease, 20.8% with model for end-stage liver disease scores of 9.5±3.0, and 93.0% with liver stiffness measurements ≥10kPa) or a validation population (n=789', 'patients with compensated liver disease', '2368 patients with chronic liver disease', 'patients with compensated chronic liver disease']",[],"['spared endoscopy rates', 'Test performance and safety']","[{'cui': 'C0014867', 'cui_str': 'Esophageal varices'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042721', 'cui_str': 'Viral hepatitis'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C4048785', 'cui_str': 'Model for end stage liver disease score'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C3839044', 'cui_str': 'Compensated liver disease'}]",[],"[{'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",2368.0,0.03324,Differences in spared endoscopy rates were significant (P≤.001) except for B6C vs ANTICIPATE and in missed VNT only for EB6C vs the others (P≤.009).,"[{'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Berger', 'Affiliation': 'Hepato-Gastroenterology Department, University Hospital, Angers, France; HIFIH Laboratory, UPRES 3859, UNIV Angers, France.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Ravaioli', 'Affiliation': 'Gastroenterology and Hepatology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Farcau', 'Affiliation': 'Liver Unit, Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Festi', 'Affiliation': 'Gastroenterology and Hepatology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Horia', 'Initials': 'H', 'LastName': 'Stefanescu', 'Affiliation': 'Liver Unit, Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca, Romania.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Buisson', 'Affiliation': 'Hepato-Gastroenterology Department, University Hospital, Angers, France; HIFIH Laboratory, UPRES 3859, UNIV Angers, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Nahon', 'Affiliation': 'Hepato-Gastroenterology Department, Paris Seine-Saint-Denis University Hospitals, APHP, Jean Verdier Hospital, Bondy, France; University Paris 13, Bobigny, France; INSERM UMR 1162, Paris, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Bureau', 'Affiliation': 'Hepato-Gastroenterology Department, Purpan University Hospital, Toulouse, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Ganne-Carriè', 'Affiliation': 'Hepato-Gastroenterology Department, Paris Seine-Saint-Denis University Hospitals, APHP, Jean Verdier Hospital, Bondy, France; University Paris 13, Bobigny, France; INSERM UMR 1162, Paris, France.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Berzigotti', 'Affiliation': 'Hepatology, Swiss Liver Center, Visceral Surgery and Medicine Clinic, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'de Ledinghen', 'Affiliation': 'Hepatology Department, Haut-Lévêque Hospital, Bordeaux, France.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Petta', 'Affiliation': 'Department of Gastroenterology and Hepatology, PROMISE, University of Palermo, Palermo, Italy.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Calès', 'Affiliation': 'Hepato-Gastroenterology Department, University Hospital, Angers, France; HIFIH Laboratory, UPRES 3859, UNIV Angers, France; INSERM UMR 1162, Paris, France. Electronic address: paul.cales@univ-angers.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.06.022']
1219,32566980,Partial resection of the infrapatellar fat pad during anterior cruciate ligament reconstruction has no effect on clinical outcomes including anterior knee pain.,"BACKGROUND


Anterior knee pain (AKP) is a major complication that occurs after anterior cruciate ligament reconstruction (ACLR), even when hamstring tendon (HT) grafts are used. Damage to the infrapatellar fat pad (IPFP) during arthroscopy can cause AKP. The purpose of this study was to evaluate the influence of IPFP preservation on clinical outcomes, including AKP, in patients who underwent ACLR with HT autografts using the inside-out technique.
METHODS


Forty-two patients who underwent primary ACLR with HT autografts were prospectively assessed for 2 years after surgery. They were randomly selected to undergo treatment with as much intercondylar IPFP preservation as possible or with intercondylar IPFP resection to confirm the ACL origin on the femoral and tibial sides, especially the femoral footprint in deep flexion of the knee joint. The total IPFP volume was calculated using sagittal MR images before and 6 months after surgery. The patients completed a subjective knee score questionnaire and were assessed for patellar tendon tenderness and pain with the half-squat test or single-leg hop test at 6 months and 2 years postoperatively.
RESULTS


There were no differences in the patient characteristics, including age, sex, BMI, time from injury to surgery, and meniscus tear. The difference in the total size of the IPFP preserved was significant (P = 0.004). However, there were no significant differences in the subjective knee scores. Moreover, there were no differences in the clinical assessment parameters between the IPFP preservation and resection groups.
CONCLUSIONS


The size of the IPFP decreased more in the resection group than in the preservation group at 6 months after surgery. However, partial IPFP resection, which was used to better visualize the origin of the ACL, had no effect on the clinical outcomes, including AKP.
LEVEL OF EVIDENCE


Level II.",2020,The difference in the total size of the IPFP preserved was significant (P = 0.004).,"['Forty-two patients who underwent primary ACLR with HT autografts were prospectively assessed for 2\xa0years after surgery', 'patients who underwent ACLR with HT autografts using the inside-out technique', 'anterior knee pain']","['IPFP', 'intercondylar IPFP preservation as possible or with intercondylar IPFP resection to confirm the ACL origin', 'anterior cruciate ligament reconstruction (ACLR', 'anterior cruciate ligament reconstruction']","['total IPFP volume', 'size of the IPFP', 'subjective knee score questionnaire', 'subjective knee scores', 'patellar tendon tenderness and pain', 'total size of the IPFP']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain'}]","[{'cui': 'C0224706', 'cui_str': 'Structure of infrapatellar fat pad'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0224706', 'cui_str': 'Structure of infrapatellar fat pad'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",42.0,0.0175713,The difference in the total size of the IPFP preserved was significant (P = 0.004).,"[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Asai', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.'}, {'ForeName': 'Junsuke', 'Initials': 'J', 'LastName': 'Nakase', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan. nakase1007@yahoo.co.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Oshima', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Shimozaki', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.'}, {'ForeName': 'Rikuto', 'Initials': 'R', 'LastName': 'Yoshimizu', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medical Science, Kanazawa University, 13-1 Takara-machi, Kanazawa, 920-8641, Japan.'}]",Archives of orthopaedic and trauma surgery,['10.1007/s00402-020-03520-5']
1220,32567975,Effects of aerobic and cognitively-engaging physical activity on academic skills: A cluster randomized controlled trial.,"This cluster randomized controlled trial (trial-number #) compares effects of two school-based physical activity interventions (aerobic vs. cognitively-engaging) on reading, mathematics, and spelling achievement; and whether effects are influenced by volume of moderate-to-vigorous physical activity and baseline achievement. Twenty-two primary schools participated, where a third and fourth grade class were randomly assigned to the intervention or control group. Intervention groups were randomly assigned to a 14-week aerobic or cognitively-engaging intervention, receiving four physical education lessons a week. Control groups followed their regular physical education program. Academic achievement of 891 children (mean age 9.17 years, 49.4% boys) was assessed with standardized tests before and after the interventions. Post-Test academic achievement did not significantly differ between intervention groups and control group. A higher volume of moderate-to-vigorous physical activity resulted in better post-test mathematics achievement in both intervention groups, and post-test spelling achievement in the cognitively engaging intervention group. Compared to the control group, lower achievers in reading performed better in reading after the cognitively-engaging intervention. A combination of moderate-to-vigorous physical activity and cognitively-engaging exercises seems to have the most beneficial effects. Future intervention studies should take into account quantitative and qualitative aspects of physical activity, and children's baseline academic achievement.",2020,"A higher volume of moderate-to-vigorous physical activity resulted in better post-test mathematics achievement in both intervention groups, and post-test spelling achievement in the cognitively engaging intervention group.","['891 children (mean age 9.17\xa0years, 49.4% boys', 'academic skills', 'Twenty-two primary schools participated, where a third and fourth grade class']","['regular physical education program', '14-week aerobic or cognitively-engaging intervention, receiving four physical education lessons a week', 'aerobic and cognitively-engaging physical activity', 'two school-based physical activity interventions (aerobic vs. cognitively-engaging']","['Post-Test academic achievement', 'reading, mathematics, and spelling achievement']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",891.0,0.0342309,"A higher volume of moderate-to-vigorous physical activity resulted in better post-test mathematics achievement in both intervention groups, and post-test spelling achievement in the cognitively engaging intervention group.","[{'ForeName': 'Anne G M', 'Initials': 'AGM', 'LastName': 'De Bruijn', 'Affiliation': 'Groningen Institute for Educational Research, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Danny D N M', 'Initials': 'DDNM', 'LastName': 'Kostons', 'Affiliation': 'Groningen Institute for Educational Research, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Irene M J', 'Initials': 'IMJ', 'LastName': 'Van Der Fels', 'Affiliation': 'Center for Human Movement Sciences, University Medical Center Groningen, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Visscher', 'Affiliation': 'Center for Human Movement Sciences, University Medical Center Groningen, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Oosterlaan', 'Affiliation': 'Faculty of Behavioural and Movement Sciences, Vrije Universiteit Amsterdam , Amsterdam, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Hartman', 'Affiliation': 'Center for Human Movement Sciences, University Medical Center Groningen, University of Groningen , Groningen, The Netherlands.'}, {'ForeName': 'Roel J', 'Initials': 'RJ', 'LastName': 'Bosker', 'Affiliation': 'Groningen Institute for Educational Research, University of Groningen , Groningen, The Netherlands.'}]",Journal of sports sciences,['10.1080/02640414.2020.1756680']
1221,32563858,Capitalizing on cross-language similarities in intervention with bilingual children.,"PURPOSE


This study examined the effects of a vocabulary intervention for bilingual children that was conducted in children's first language, Spanish, and included explicit instruction on cognates. We measured effects in terms of change from pre- to post-intervention in Spanish as well as associations with the non-target language, English.
METHOD


Participants were 12 Spanish-English bilingual children, aged 6-8 years, with and without Developmental Language Disorder. Children completed the intervention in pairs (one child with DLD and a typically developing peer) for 70-minute sessions, 3 days a week, for four weeks. Intervention targeted 32 words (16 cognates, 16 non-cognates) using four storybooks (8 words/book) and interactive activities that highlighted similarities across languages. Pre- and post-intervention measures in Spanish and English included tasks of word definition and cognate facilitation.
RESULTS


As a group, children showed improvement in definition quality and cognate naming in Spanish. There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD. All children showed positive cross-language correlations on post-intervention measures.
CONCLUSIONS


Bilingual children, with and without DLD, have the capacity to improve in their awareness and use of cognates. Explicit teaching of cognates can be an effective tool for building vocabulary skills. Children with DLD may need additional time and support to apply their knowledge of cognates to vocabulary learning.",2020,"There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD.","[""bilingual children that was conducted in children's first language, Spanish, and included explicit instruction on cognates"", 'Children with DLD', 'Participants were 12 Spanish-English bilingual children, aged 6-8 years, with and without Developmental Language Disorder', 'Spanish and English']",['vocabulary intervention'],"['included tasks of word definition and cognate facilitation', 'definition quality and cognate naming', 'positive cross-language correlations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0557073', 'cui_str': 'First language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023014', 'cui_str': 'Developmental language disorder'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0037415', 'cui_str': 'Social Facilitation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",,0.0437372,"There was a positive correlation between definition quality and cognate naming for the typically developing children, but not for the children with DLD.","[{'ForeName': 'Quynh', 'Initials': 'Q', 'LastName': 'Dam', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States; University of California San Diego, 9500 Gilman Dr, La Jolla, CA 92093, United States. Electronic address: qdam@sdsu.edu.'}, {'ForeName': 'Giang T', 'Initials': 'GT', 'LastName': 'Pham', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: gpham@sdsu.edu.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Pruitt-Lord', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: spruitt@sdsu.edu.'}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Limon-Hernandez', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: jlimon-hernandez@sdsu.edu.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Goodwiler', 'Affiliation': 'San Diego State University, 5500 Campanile Drive, San Diego, CA 92182, United States. Electronic address: cgoodwiler@sdsu.edu.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106004']
1222,32564236,Does prehabilitation modify muscle mass in patients with rectal cancer undergoing neoadjuvant therapy? A subanalysis from the REx randomised controlled trial.,"BACKGROUND


Patients with rectal cancer who present with sarcopenia (low muscle mass) are at significantly greater risk of postoperative complications and reduction in disease-free survival. We performed a subanalysis of a randomised controlled study [the REx trial; www.isrctn.com ; 62859294] to assess the potential of prehabilitation to modify muscle mass in patients having neoadjuvant chemoradiotherapy (NACRT).
METHODS


Patients scheduled for NACRT, then potentially curative surgery (August 2014-March 2016) had baseline physical assessment and psoas muscle mass measurement (total psoas index using computed tomography-based measurements). Participants were randomised to either the intervention (13-17-week telephone-guided graduated walking programme) or control group (standard care). Follow-up testing was performed 1-2 weeks before surgery.
RESULTS


The 44 patients had a mean age of 66.8 years (SD 9.6) and were male (64%); white (98%); American Society of Anesthesiologists class 2 (66%); co-morbid (58%); overweight (72%) (body mass index ≥ 25 kg/m 2 ). At baseline, 14% were sarcopenic. At follow-up, 13 (65%) of patients in the prehabilitation group had increased muscle mass versus 7 (35%) that experienced a decrease. Conversely, 16 (67%) controls experienced a decrease in muscle mass and 8 (33%) showed an increase. An adjusted linear regression model estimated a mean treatment difference in Total Psoas Index of 40.2mm 2 /m 2  (95% CI - 3.4 to 83.7) between groups in change from baseline (p = 0.07).
CONCLUSIONS


Prehabilitation improved muscle mass in patients with rectal cancer who had NACRT. These results need to be explored in a larger trial to determine if the poorer short- and long-term patient outcomes associated with low muscle mass can be minimised by prehabilitation.",2020,"At follow-up, 13 (65%) of patients in the prehabilitation group had increased muscle mass versus 7 (35%) that experienced a decrease.","['Patients with rectal cancer who present with sarcopenia (low muscle mass', 'patients having neoadjuvant chemoradiotherapy (NACRT', 'patients with rectal cancer who had NACRT', '44 patients had a mean age of 66.8\xa0years (SD 9.6) and were male (64%); white (98%); American Society of Anesthesiologists class 2 (66%); co-morbid (58%); overweight (72', 'patients with rectal cancer undergoing neoadjuvant therapy', 'Patients scheduled for NACRT, then potentially curative surgery (August 2014-March 2016) had']","['telephone-guided graduated walking programme) or control group (standard care', 'baseline physical assessment and psoas muscle mass measurement (total psoas index using computed tomography-based measurements']","['muscle mass', 'Total Psoas Index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0588053', 'cui_str': 'Graduate'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085221', 'cui_str': 'Structure of psoas muscle'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.16134,"At follow-up, 13 (65%) of patients in the prehabilitation group had increased muscle mass versus 7 (35%) that experienced a decrease.","[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Moug', 'Affiliation': 'Department of Surgery, Royal Alexandra Hospital, Corsebar Road, Paisley, PA2 9PN, UK. susanmoug@nhs.net.'}, {'ForeName': 'S J E', 'Initials': 'SJE', 'LastName': 'Barry', 'Affiliation': 'Department of Mathematics and Statistics, Strathclyde University, Glasgow, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Maguire', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Johns', 'Affiliation': 'Western General Hospital, Crewe Road South, Edinburgh, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dolan', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'R J C', 'Initials': 'RJC', 'LastName': 'Steele', 'Affiliation': 'Ninewells Hospital and Medical School, Dundee, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Buchan', 'Affiliation': 'Department of Surgery, Royal Alexandra Hospital, Paisley, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mackay', 'Affiliation': 'Department of Surgery, Glasgow Royal Infirmary, Glasgow, UK.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Anderson', 'Affiliation': 'Division of Cancer Research, Ninewells Medical School, Dundee, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Mutrie', 'Affiliation': 'Institute of Sport, Physical Education and Health Sciences, Moray House School of Education, Edinburgh, UK.'}]",Techniques in coloproctology,['10.1007/s10151-020-02262-1']
1223,32564438,"Regular Supplementation With Resveratrol Improves Bone Mineral Density in Postmenopausal Women: A Randomized, Placebo-Controlled Trial.","Resveratrol, a naturally occurring polyphenol in red grapes and berries, can act as a phytoestrogen. It has been shown to improve both systemic and cerebral circulatory functions, possibly through activation of endothelial estrogen receptors. in vitro and in vivo studies in rodent models also indicate a bone-protective role for resveratrol, particularly in ovariectomized rat models that mimic postmenopausal osteoporosis caused by estrogen deficiency. Hypothesizing a circulatory benefit of resveratrol in bone tissue, we investigated whether resveratrol supplementation could improve bone health in postmenopausal women. The Resveratrol for Healthy Aging in Women (RESHAW) trial was a 24-month randomized, double-blind, placebo-controlled, two-period crossover intervention conducted to evaluate the effects of resveratrol (75 mg twice daily) on cognition, cerebrovascular function, bone health, cardiometabolic markers, and well-being in postmenopausal women. After 12 months of supplementation with resveratrol versus placebo, there were positive effects on bone density in the lumbar spine (+0.016 ± 0.003 g/cm 2  ) and neck of femur (+0.005 ± 0.002 g/cm 2  ), which were accompanied by a 7.24% reduction in C-terminal telopeptide type-1 collagen levels, a bone resorption marker, compared with placebo. The increase in bone mineral density in the femoral neck resulted in an improvement in T-score (+0.070 ± 0.018) and a reduction in the 10-year probability of major and hip fracture risk. The magnitude of improvement was higher in women with poor bone health biomarker status. Importantly, the improvement in femoral neck T-score with resveratrol correlated with improvement in perfusion. Our subanalysis also revealed that the bone-protective benefit of resveratrol was greater in participants who supplemented with vitamin D plus calcium. Regular supplementation with 75 mg of resveratrol twice daily has the potential to slow bone loss in the lumbar spine and femoral neck, common fracture sites in postmenopausal women without overt osteoporosis. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.",2020,The increase in bone mineral density in the femoral neck resulted in an improvement in T-score (+0.070±0.018) and a reduction in the 10-year probability of major and hip fracture risk.,"['postmenopausal women', 'women with poor bone health biomarker status', 'postmenopausal women without overt osteoporosis']","['resveratrol', 'placebo', 'vitamin D plus calcium', 'Regular supplementation with resveratrol', 'resveratrol supplementation']","['bone mineral density', 'bone density', 'femoral neck T-score', 'cognition, cerebrovascular function, bone health, cardiometabolic markers', 'bone health', '10-year probability of major and hip fracture risk']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.247533,The increase in bone mineral density in the femoral neck resulted in an improvement in T-score (+0.070±0.018) and a reduction in the 10-year probability of major and hip fracture risk.,"[{'ForeName': 'Rachel Hx', 'Initials': 'RH', 'LastName': 'Wong', 'Affiliation': 'School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Jay Jay', 'Initials': 'JJ', 'LastName': 'Thaung Zaw', 'Affiliation': 'School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Cory J', 'Initials': 'CJ', 'LastName': 'Xian', 'Affiliation': 'UniSA Clinical & Health Sciences and Cancer Research Institute, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Peter Rc', 'Initials': 'PR', 'LastName': 'Howe', 'Affiliation': 'School of Biomedical Sciences and Pharmacy, University of Newcastle, Callaghan, Australia.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4115']
1224,32564459,"Single- vs multiple-layer wound closure for flank incisions: results of a prospective, randomised, double-blinded multicentre study.","OBJECTIVE


To compare the incidence of postoperative flank bulges between patients with multiple-layer closure and single superficial-layer closure after retroperitoneal surgery via open flank incision in the SIngle versus MUltiple-LAyer wound Closure for flank incision (SIMULAC) trial.
PATIENTS AND METHODS


The study was a randomised controlled, patient- and assessor-blinded, multicentre trial. Between May 2015 and February 2017, 225 patients undergoing flank incisions were randomised 1:1 to a multiple-layer closure (SIMULAC-I) or a single superficial-layer closure (SIMULAC-II) group. The primary outcome was the occurrence of a flank bulge 6 months after surgery.
RESULTS


Overall, 177 patients (90 in SIMULAC-I, 87 in SIMULAC-II) were eligible for final assessment. The cumulative incidence of a flank bulge was significantly higher in the SIMULAC-II group (51.7%) compared to the SIMULAC-I group [34.4%; odds ratio (OR) 2.04, 95% confidence interval (CI) 1.11-3.73; P = 0.02]. Rate of severe postoperative complications (4.4% SIMULAC-I vs 10.3% SIMULAC-II; P = 0.21) or hernia (6.7% SIMULAC-I vs 10.3% SIMULAC-II; P = 0.59) was similar between the groups. There was no difference in pain (visual analogue scale) and the requirement for pain medication at 6 months postoperatively. Quality of life assessed with the European Quality of Life 5 Dimensions Questionnaire was higher in the SIMULAC-I group compared to the SIMULAC-II group at 6 months postoperatively, with a (median range) score of 80 (30-100) vs 75 (5-100) (P = 0.012).
CONCLUSION


The overall risk of a flank bulge after flank incision is high. Multiple-layer closure after flank incision should be performed as a standard procedure.",2020,"Quality of life assessed with the EQ-5D was higher in the SIMULAC-I group compared to the SIMULAC-II group 6 months postoperatively (80 [30-100] vs. 75 [5-100]; P = 0.012).
","['patients with multiple-layer closure and single superficial-layer closure after retroperitoneal surgery via open flank incision', '177 patients (90 SIMULAC-I, 87 SIMULAC-II) were eligible for final assessment', 'Between May 2015 and February 2017, 225 patients undergoing flank incision']","['Single-layered versus multiple-layered wound closure for flank incision', 'multiple-layered closure (SIMULAC-I) and a single superficial layered closure (SIMULAC-II) group']","['overall risk of a flank bulge', 'Rate of severe postoperative complications', 'occurrence of a flank bulge 6 months after surgery', 'pain (visual analogue scale', 'cumulative incidence of a flank bulge', 'hernia', 'Quality of life assessed with the EQ-5D']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0035359', 'cui_str': 'Retroperitoneal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0198492', 'cui_str': 'Incision of flank'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4517652', 'cui_str': '225'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0198492', 'cui_str': 'Incision of flank'}, {'cui': 'C1293123', 'cui_str': 'Layered closure - action'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0230171', 'cui_str': 'Structure of lateral region of abdomen'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",225.0,0.134905,"Quality of life assessed with the EQ-5D was higher in the SIMULAC-I group compared to the SIMULAC-II group 6 months postoperatively (80 [30-100] vs. 75 [5-100]; P = 0.012).
","[{'ForeName': 'Maximilian C', 'Initials': 'MC', 'LastName': 'Kriegmair', 'Affiliation': 'Department of Urology and Urosurgery, University Hospital Manheim, Mannheim, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Younsi', 'Affiliation': 'Department of Urology and Urosurgery, University Hospital Manheim, Mannheim, Germany.'}, {'ForeName': 'Kiriaki', 'Initials': 'K', 'LastName': 'Hiller', 'Affiliation': 'Department of Urology and Urosurgery, University Hospital Manheim, Mannheim, Germany.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Leitsmann', 'Affiliation': 'Department of Urology, University Hospital Göttingen, Göttingen, Germany.'}, {'ForeName': 'Karl F', 'Initials': 'KF', 'LastName': 'Kowalewski', 'Affiliation': 'Department of Urology and Urosurgery, University Hospital Manheim, Mannheim, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Siegel', 'Affiliation': 'Department of Urology and Urosurgery, University Hospital Manheim, Mannheim, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Rothamel', 'Affiliation': 'Urological Hospital Munich-Planegg, Planegg, Germany.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ritter', 'Affiliation': 'Department of Urology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Bolenz', 'Affiliation': 'Department of Urology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kriegmair', 'Affiliation': 'Urological Hospital Munich-Planegg, Planegg, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Trojan', 'Affiliation': 'Department of Urology, University Hospital Göttingen, Göttingen, Germany.'}, {'ForeName': 'Maurice S', 'Initials': 'MS', 'LastName': 'Michel', 'Affiliation': 'Department of Urology and Urosurgery, University Hospital Manheim, Mannheim, Germany.'}]",BJU international,['10.1111/bju.15148']
1225,32565123,An acute bout of swimming increases post-exercise energy intake in young healthy men and women.,"Single bouts of land-based exercise (for example, walking, running, cycling) do not typically alter post-exercise energy intake on the day of exercise. However, anecdotal and preliminary empirical evidence suggests that swimming may increase appetite and energy intake. This study compared the acute effects of swimming on appetite, energy intake, and food preference and reward, versus exertion-matched cycling and a resting control. Thirty-two men (n = 17; mean ± SD age 24 ± 2 years, body mass index [BMI] 25.0 ± 2.6 kg/m 2 ) and women (n = 15; age 22 ± 3 years, BMI 22.8 ± 2.3 kg/m 2 ) completed three experimental trials (swimming, cycling, control) in a randomised, crossover design. The exercise trials involved 60-min of 'hard' exercise (self-selected rating of perceived exertion: 15) performed 90-min after a standardised breakfast. Food preference and reward were assessed via the Leeds Food Preference Questionnaire 15-min after exercise, whilst ad libitum energy intake was determined 30-min after exercise. The control trial involved identical procedures except no exercise was performed. Compared with control (3259 ± 1265 kJ), swimming increased ad libitum energy intake (3857 ± 1611 kJ; ES = 0.47, 95% CI of the mean difference between trials 185, 1010 kJ, P = 0.005); the magnitude of increase was smaller after cycling (3652 ± 1619 kJ; ES = 0.31, 95% CI -21, 805 kJ, P = 0.062). Ad libitum energy intake was similar between swimming and cycling (ES = 0.16, 95% CI -207, 618 kJ, P = 0.324). This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control. This study has identified an orexigenic effect of swimming. Further research is needed to identify the responsible mechanism(s), including the relevance of water immersion and water temperature per se.",2020,This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control.,"['young healthy men and women', 'Thirty-two men (n\u202f=\u202f17; mean\u202f±\u202fSD age 24\u202f±\u202f2 years, body mass index [BMI] 25.0\u202f±\u202f2.6\u202fkg/m 2 ) and women (n\u202f=\u202f15', 'age 22\u202f±\u202f3 years, BMI 22.8\u202f±\u202f2.3\u202fkg/m 2 ']","[""60-min of 'hard' exercise (self-selected rating of perceived exertion: 15) performed 90-min after a standardised breakfast"", 'Single bouts of land-based exercise']","['appetite, energy intake, and food preference and reward, versus exertion-matched cycling', 'Ad libitum energy intake', 'appetite and energy intake']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517633', 'cui_str': '2.6'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]",,0.135485,This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control.,"[{'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: A.E.Thackray@lboro.ac.uk.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Willis', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: S.Willis2@lboro.ac.uk.'}, {'ForeName': 'Aron P', 'Initials': 'AP', 'LastName': 'Sherry', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: A.P.Sherry@lboro.ac.uk.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Clayton', 'Affiliation': 'School of Science and Technology, Nottingham Trent University, UK. Electronic address: David.Clayton@ntu.ac.uk.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Broom', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, UK. Electronic address: ad5173@coventry.ac.uk.'}, {'ForeName': 'Mayada', 'Initials': 'M', 'LastName': 'Demashkieh', 'Affiliation': 'Department of Physical Education and Sport Science, Nanyang Technological University, Singapore. Electronic address: Mayada.Demashkieh@nie.edu.sg.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Sargeant', 'Affiliation': 'National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK; Diabetes Research Centre, University of Leicester, UK. Electronic address: js928@leicester.ac.uk.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK. Electronic address: L.James@lboro.ac.uk.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'Faculty of Medicine and Health, University of Leeds, UK. Electronic address: G.S.Finlayson@leeds.ac.uk.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: D.J.Stensel@lboro.ac.uk.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: j.a.king@lboro.ac.uk.'}]",Appetite,['10.1016/j.appet.2020.104785']
1226,32518064,GIP and GLP-1 Potentiate Sulfonylurea-Induced Insulin Secretion in Hepatocyte Nuclear Factor 1α Mutation Carriers.,"Sulfonylureas (SUs) provide an efficacious first-line treatment in patients with hepatocyte nuclear factor 1α (HNF1A) diabetes, but SUs have limitations due to risk of hypoglycemia. Treatment based on the incretin hormones glucose-dependent insulinotropic peptide (GIP) and glucagon-like peptide 1 (GLP-1) is characterized by their glucose-dependent insulinotropic actions without risk of hypoglycemia. The effect of SUs together with GIP or GLP-1, respectively, on insulin and glucagon secretion in patients with HNF1A diabetes is currently unknown. To investigate this, 10  HNF1A  mutation carriers and 10 control subjects without diabetes were recruited for a double-blinded, placebo-controlled, crossover study including 6 experimental days in a randomized order involving 2-h euglycemic-hyperglycemic clamps with coadministration of:  1 ) SU (glimepiride 1 mg) or placebo, combined with  2 ) infusions of GIP (1.5 pmol/kg/min), GLP-1 (0.5 pmol/kg/min), or saline (NaCl). In  HNF1A  mutation carriers, we observed:  1 ) hypoinsulinemia,  2 ) insulinotropic effects of both GIP and GLP-1,  3 ) additive to supra-additive effects on insulin secretion when combining SU+GIP and SU+GLP-1, respectively, and  4 ) increased fasting and arginine-induced glucagon levels compared with control subjects without diabetes. Our study suggests that a combination of SU and incretin-based treatment may be efficacious in patients with HNF1A diabetes via potentiation of glucose-stimulated insulin secretion.",2020,"Sulfonylureas (SUs) provide an efficacious first-line treatment in patients with hepatocyte nuclear factor 1-alpha (HNF1A)-diabetes, but SUs have limitations due to risk of hypoglycemia.","['patients with HNF1A-diabetes', 'patients with hepatocyte nuclear factor 1-alpha (HNF1A)-diabetes', 'ten  HNF1A  mutation carriers and ten non-diabetic controls']","['GIP and GLP-1', 'euglycemic-hyperglycemic clamps with co-administration of 1) SU (glimepiride 1 mg) or placebo, combined with 2) infusions of either GIP', 'GLP-1 (0.5 pmol/kg/min) or saline (NaCl', 'Sulfonylureas (SUs', 'placebo']","['fasting and arginine-induced glucagon levels', 'insulin and glucagon secretion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1451774', 'cui_str': 'HNF1A protein, human'}, {'cui': 'C0209278', 'cui_str': 'Liver-Specific Transcription Factor LF-B1'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0986239', 'cui_str': 'glimepiride 1 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0439192', 'cui_str': 'pmol'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0574518', 'cui_str': 'Susu language'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0337437', 'cui_str': 'Glucagon measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0036536', 'cui_str': 'secretion'}]",,0.0900443,"Sulfonylureas (SUs) provide an efficacious first-line treatment in patients with hepatocyte nuclear factor 1-alpha (HNF1A)-diabetes, but SUs have limitations due to risk of hypoglycemia.","[{'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Christensen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Hædersdal', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Storgaard', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Kathrine', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Nina L', 'Initials': 'NL', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Hellerup, Denmark t.vilsboll@dadlnet.dk.'}]",Diabetes,['10.2337/db20-0074']
1227,32524934,"Examining child intake frequency, mothers' own liking and child early exposure as potential predictors of child liking for restricted foods and drinks at 5 years old.","OBJECTIVE


To examine longitudinal patterns of child introduction to foods and drinks targeted for restriction by parents and associations between child intake frequency, mother's own liking, child early exposure and child liking for restricted foods and drinks at 5 years old.
DESIGN


The study involved secondary analyses of longitudinal data from mothers and children participating in the NOURISH randomised controlled trial. Patterns of descriptive data were examined, and a binary logistic regression model tested for prediction of child liking of a selection of restricted foods and drinks.
SETTING


Brisbane and Adelaide, Australia.
PARTICIPANTS


Two hundred and eleven mothers and their first born 5-year-old children.
RESULTS


The proportion of children who had tried the selected restricted foods and drinks progressively increased from 14 months to 5 years old. Mothers' own high liking for both sweet and savoury restricted foods and drinks predicted child high liking for the same items at 5 years old. Child high intake frequency at 5 years old also predicted child high liking for sweet foods and drinks, but child early exposure did not predict child liking for the restricted items examined.
CONCLUSIONS


These results challenge the belief that limiting children's intake of foods high in sugar, fat and/or salt will increase their liking for them. Findings instead suggest that restricting children's access to such foods may be beneficial. While further research is required, mothers should be made aware that their own food preferences may inadvertently influence their child's liking for the very foods they are trying to restrict.",2020,Mothers' own high liking for both sweet and savoury restricted foods and drinks predicted child high liking for the same items at 5 years old.,"['Two hundred and eleven mothers and their first born 5-year-old children', 'Brisbane and Adelaide, Australia', 'mothers and children participating in the NOURISH randomised controlled trial']",[],[],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],[],211.0,0.0156282,Mothers' own high liking for both sweet and savoury restricted foods and drinks predicted child high liking for the same items at 5 years old.,"[{'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Jackson', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, Queensland4059, Australia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Jansen', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Brisbane, Queensland4059, Australia.'}, {'ForeName': 'Kimberley M', 'Initials': 'KM', 'LastName': 'Mallan', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Brisbane, Queensland, Australia.'}]",Public health nutrition,['10.1017/S1368980020000312']
1228,32682929,"Antioxidant supplementation, redox deficiencies and exercise performance: A falsification design.","The aim of the present study was to validate the idea of personalized redox supplementation by subjecting individuals to targeted and non-targeted antioxidant supplementation schemes. Seventy-three volunteers were screened for plasma vitamin C and erythrocyte glutathione levels. Three groups were formed: i) the ""low vitamin C″ group (12 individuals with the lowest vitamin C levels; Low VitC), ii) the ""low glutathione"" group (12 individuals with the lowest glutathione levels; Low GSH) and iii) a control group (12 individuals with moderate vitamin C and glutathione levels). The three groups received 1 g of vitamin C or 1.2 g of NAC daily for 30 days in a crossover design with a wash-out period of 30 days. Both antioxidant treatments reduced the increased resting systemic oxidative stress levels, assessed via urine F 2 -isoprostanes, in the Low VitC and Low GSH groups (P < .05). A significant group × time interaction (P < .05) was found for VO 2 max and isometric peak torque after both treatments, with the Low VitC and Low GSH groups exhibiting improved performance only after the targeted treatment (vitamin C and NAC, respectively). A significant group × time interaction (P < .05) was found for fatigue index after NAC treatment, but not after vitamin C treatment. No interaction was found for the Wingate test after both treatments. Most of the evidence verifies the idea that antioxidant supplementation increases performance when a particular deficiency is reversed. This indicates that the presence of oxidative stress per se does not rationalize the use of antioxidants and emphasizes the need to identify ""responsive"" phenotypes.",2020,"A significant group × time interaction (P<.05) was found for VO 2 max and isometric peak torque after both treatments, with the Low VitC and Low GSH groups exhibiting improved performance only after the targeted treatment (vitamin C and NAC, respectively).",[],"['low vitamin C"" group (12 individuals with the lowest vitamin C levels; Low VitC), ii) the ""low glutathione"" group (12 individuals with the lowest glutathione levels; Low GSH) and iii) a control group (12 individuals with moderate vitamin C and glutathione levels', 'antioxidant supplementation', 'personalized redox supplementation', 'vitamin C or 1.2g of NAC']","['Antioxidant supplementation, redox deficiencies and exercise performance', 'fatigue index', 'resting systemic oxidative stress levels', 'VO 2 max and isometric peak torque', 'plasma vitamin C and erythrocyte glutathione levels']",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201898', 'cui_str': 'Ascorbic acid measurement'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0030012', 'cui_str': 'Oxidation-reduction'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}]",73.0,0.0729379,"A significant group × time interaction (P<.05) was found for VO 2 max and isometric peak torque after both treatments, with the Low VitC and Low GSH groups exhibiting improved performance only after the targeted treatment (vitamin C and NAC, respectively).","[{'ForeName': 'Nikos V', 'Initials': 'NV', 'LastName': 'Margaritelis', 'Affiliation': 'Department of Physical Education and Sport Science at Serres, Aristotle University of Thessaloniki, Serres, Greece; Dialysis Unit, 424 General Military Hospital of Thessaloniki, Thessaloniki, Greece. Electronic address: nvmargar@auth.gr.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Paschalis', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: vpaschalis@phed.uoa.gr.'}, {'ForeName': 'Anastasios A', 'Initials': 'AA', 'LastName': 'Theodorou', 'Affiliation': 'Department of Health Sciences, School of Sciences, European University Cyprus, Nicosia, Cyprus. Electronic address: a.theodorou@euc.ac.cy.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Kyparos', 'Affiliation': 'Department of Physical Education and Sport Science at Serres, Aristotle University of Thessaloniki, Serres, Greece. Electronic address: akyparos@auth.gr.'}, {'ForeName': 'Michalis G', 'Initials': 'MG', 'LastName': 'Nikolaidis', 'Affiliation': 'Department of Physical Education and Sport Science at Serres, Aristotle University of Thessaloniki, Serres, Greece. Electronic address: nikolaidis@auth.gr.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.06.029']
1229,32470440,Longitudinal Toxicity over Time (ToxT) analysis to evaluate tolerability: a case study of lenalidomide in the CALGB 50401 (Alliance) trial.,"Evaluation of tolerability is increasingly relevant for patients with haematological malignancies treated with chronically administered therapies. Adverse events from these agents might affect the ability of patients to tolerate treatment over time. Conventional toxicity tables that include the incidence of high-grade adverse events, defined by the Common Terminology Criteria for Adverse Events, do not provide information on the time profile of these adverse events or reflect the continuous, lower grade symptomatic toxicities that are particularly relevant to treatment tolerability for patients living with indolent disease. Modern approaches to the evaluation and reporting of toxicity that capture the tolerability of treatment to the patient are imperative. In this Viewpoint, we present a focused, pilot, and longitudinal Toxicity over Time analysis of adverse events from lenalidomide and lenalidomide with rituximab in patients with follicular lymphoma treated in the CALGB 50401 (Alliance; NCT00238238) trial to define the trajectory of adverse events and quantify the burden of continuous, low-grade events. Toxicity over Time analyses provided clinically relevant descriptions of neutropenia and fatigue trajectories caused by lenalidomide that were not identified by standard analysis of the maximum grade events defined by the Common Terminology Criteria for Adverse Events. Systematic, rigorous incorporation of patient-reported outcomes in clinical trials will be crucial to our understanding of the tolerability of chronically administered therapies in patients with haematological malignancies.",2020,"Conventional toxicity tables that include the incidence of high-grade adverse events, defined by the Common Terminology Criteria for Adverse Events, do not provide information on the time profile of these adverse events or reflect the continuous, lower grade symptomatic toxicities that are particularly relevant to treatment tolerability for patients living with indolent disease.","['patients with follicular lymphoma treated in the CALGB 50401 (Alliance', 'patients with haematological malignancies', 'patients with haematological malignancies treated with chronically administered therapies', 'patients living with indolent disease']","['lenalidomide and lenalidomide with rituximab', 'lenalidomide']","['Toxicity', 'Longitudinal Toxicity over Time (ToxT) analysis to evaluate tolerability', 'grade symptomatic toxicities', 'neutropenia and fatigue trajectories']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",50401.0,0.043714,"Conventional toxicity tables that include the incidence of high-grade adverse events, defined by the Common Terminology Criteria for Adverse Events, do not provide information on the time profile of these adverse events or reflect the continuous, lower grade symptomatic toxicities that are particularly relevant to treatment tolerability for patients living with indolent disease.","[{'ForeName': 'Gita', 'Initials': 'G', 'LastName': 'Thanarajasingam', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA. Electronic address: thanarajasingam.gita@mayo.edu.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Witzig', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Habermann', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kristie A', 'Initials': 'KA', 'LastName': 'Blum', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Bartlett', 'Affiliation': 'Washington University School of Medicine, Washington University, St Louis, MO, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Flowers', 'Affiliation': 'Department of Lymphoma and Myeloma, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Brandelyn N', 'Initials': 'BN', 'LastName': 'Pitcher', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Sin-Ho', 'Initials': 'SH', 'LastName': 'Jung', 'Affiliation': 'Alliance Statistics and Data Center, Duke University, Durham, NC, USA.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Angelina', 'Initials': 'A', 'LastName': 'Tan', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Novotny', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Amylou C', 'Initials': 'AC', 'LastName': 'Dueck', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30067-3']
1230,32682992,Characterizing the analgesic effects of real and imagined acupuncture using functional and structure MRI.,"Acupuncture and imagery interventions for pain management have a long history. The present study comparatively investigated whether acupuncture and video-guided acupuncture imagery treatment (VGAIT, watching a video of acupuncture on the participant's own body while imagining it being applied) could modulate brain regional connectivity to produce analgesic effects. The study also examined whether pre-intervention brain functional and structural features could be used to predict the magnitude of analgesic effects. Twenty-four healthy participants were recruited and received four different interventions (real acupuncture, sham acupuncture, VGAIT, and VGAIT control) in random order using a cross-over design. Pain thresholds and magnetic resonance imaging (MRI) data were collected before and after each intervention. We first compared the modulatory effects of real acupuncture and VGAIT on intra- and inter-regional intrinsic brain connectivity and found that real acupuncture decreased regional homogeneity (ReHo) and functional connectivity (FC) in sensorimotor areas, whereas VGAIT increased ReHo in basal ganglia (BG) (i.e., putamen) and FC between the BG subcortical network and default mode network. The altered ReHo and FC were associated with changes in pain threshold after real acupuncture and VGAIT, respectively. A multimodality fusion approach with pre-intervention ReHo and gray matter volume (GMV) as features was used to explore the brain profiles underlying individual variability of pain threshold changes by real acupuncture and VGAIT. Variability in acupuncture responses was associated with ReHo and GMV in BG, whereas VGAIT responses were associated with ReHo and GMV in the anterior insula. These results suggest that, through different pathways, both real acupuncture and VGAIT can modulate brain systems to produce analgesic effects.",2020,"The altered ReHo and FC were associated with changes in pain threshold after real acupuncture and VGAIT, respectively.",['Twenty-four healthy participants'],"['real acupuncture and VGAIT', 'acupuncture and video-guided acupuncture imagery treatment (VGAIT, watching a video of acupuncture', 'pre-intervention ReHo and grey matter volume (GMV', 'interventions (real acupuncture, sham acupuncture, VGAIT, and VGAIT control', 'Acupuncture and imagery interventions']","['pain threshold', 'Pain thresholds and magnetic resonance imaging (MRI) data', 'regional homogeneity (ReHo) and functional connectivity (FC']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",24.0,0.0799386,"The altered ReHo and FC were associated with changes in pain threshold after real acupuncture and VGAIT, respectively.","[{'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Cao', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Yiheng', 'Initials': 'Y', 'LastName': 'Tu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Scott P', 'Initials': 'SP', 'LastName': 'Orr', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States; Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA, United States. Electronic address: jkong2@mgh.harvard.edu.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117176']
1231,32534040,Oral resveratrol supplementation improves Metabolic Syndrome features in obese patients submitted to a lifestyle-changing program.,"AIMS


The aim of the present study was to evaluate the oral resveratrol effects associated with diet and physical training changes on anthropometric and biochemical parameters.
MAIN METHODS


25 individuals aged from 30 to 60 years old; with Body Mass Index (BMI) ≥ 30 kg/m 2  were included in the study. Following the primary evaluation (anthropometric and clinical), the patients were randomly divided into 2 groups: (1) Placebo: Physical activity program + Diet + Placebo; (2) Resveratrol: Physical activity program + Diet + Resveratrol (RVS) (250 mg/day) for three months. Anthropometric and biochemical parameters were evaluated at baseline and after the treatment period.
KEY FINDINGS


The main findings showed that the resveratrol supplementation improved total cholesterol (TC), High-density Lipoprotein cholesterol (HDL-c), Very-low density Lipoprotein cholesterol (VLDL-c), urea, creatinine and albumin serum levels.
SIGNIFICANCE


These findings indicate that this polyphenol may be an option to potentiate the beneficial effects induced by dietary and physical activity programs in the Metabolic Syndrome (MetS) treatment.",2020,"Following the primary evaluation (anthropometric and clinical), the patients were randomly divided into 2 groups: (1) Placebo: Physical activity program + Diet + Placebo; (2) Resveratrol:","['25 individuals aged from 30 to 60\u202fyears old; with Body Mass Index (BMI)\u202f≥\u202f30\u202fkg/m 2  were included in the study', 'obese patients submitted to a lifestyle-changing program']","['polyphenol', 'Oral resveratrol supplementation', 'Physical activity program\u202f+\u202fDiet\u202f+\u202fResveratrol (RVS', 'Placebo: Physical activity program\u202f+\u202fDiet\u202f+\u202fPlacebo; (2) Resveratrol']","['Metabolic Syndrome features', 'total cholesterol (TC), High-density Lipoprotein cholesterol (HDL-c), Very-low density Lipoprotein cholesterol (VLDL-c), urea, creatinine and albumin serum levels', 'Anthropometric and biochemical parameters']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0036773', 'cui_str': 'Serum Albumin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",25.0,0.0319773,"Following the primary evaluation (anthropometric and clinical), the patients were randomly divided into 2 groups: (1) Placebo: Physical activity program + Diet + Placebo; (2) Resveratrol:","[{'ForeName': 'G C', 'Initials': 'GC', 'LastName': 'Batista-Jorge', 'Affiliation': 'Laboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Barcala-Jorge', 'Affiliation': 'Laboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Silveira', 'Affiliation': 'Laboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Lelis', 'Affiliation': 'Laboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'J M O', 'Initials': 'JMO', 'LastName': 'Andrade', 'Affiliation': 'Laboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'A M B', 'Initials': 'AMB', 'LastName': 'de Paula', 'Affiliation': 'Laboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'A L S', 'Initials': 'ALS', 'LastName': 'Guimarães', 'Affiliation': 'Laboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, Minas Gerais, Brazil.'}, {'ForeName': 'S H S', 'Initials': 'SHS', 'LastName': 'Santos', 'Affiliation': 'Laboratory of Health Science, Postgraduate Program in Health Sciences, Universidade Estadual de Montes Claros (Unimontes), Montes Claros, Minas Gerais, Brazil; Institute of Agricultural Sciences, Food Engineering College, Universidade Federal de Minas Gerais (UFMG), Montes Claros, Minas Gerais, Brazil. Electronic address: sergiosousas@ufmg.br.'}]",Life sciences,['10.1016/j.lfs.2020.117962']
1232,32538009,[Clinical observation of filiform fire needling on moderate and severe pain in advanced cancer].,"OBJECTIVE


To evaluate the clinical effect of filiform fire needling on moderate and severe pain in advanced cancer.
METHODS


A total of 66 patients with moderate and severe pain in advanced cancer were randomly divided into an observation group (34 cases, 4 cases dropped off) and a control group (32 cases, 2 cases dropped off). The two groups were treated with oral analgesics continuously for 4 weeks. The moderate pain patients was given bucinnazine hydrochloride tablets (starting at 30 mg, once every 6 hours, increasing by 30%-50% until the titration volume was reached), and the severe pain patients were given oxycodone hydrochloride sustained-release tablets (starting at 20 mg every 12 hours and increasing by 25%-50% until the titration volume was reached). The observation group was cooperated with filiform fire needling at  ashi  point, Zusanli (ST 36), Liangqiu (ST 34), Qihai (CV 6), Guanyuan(CV 4), Quchi (LI 11) and Waiguan (TE 5) once every other day for 4 weeks. The changes of numerical rating scales (NRS) scores were observed in both groups before and after treatment, and the amount of analgesics and the incidence of adverse reactions were recorded. The clinical effects in the two groups were evaluated.
RESULTS


The effective rate was 90.0% (27/30) in the observation group, which was higher than 66.7% (20/30) in the control group ( P <0.05). After treatment, the NRS scores of both groups were lower than those before treatment ( P <0.05), and the reducing degree in the observation group was larger than that in the control group ( P <0.05). The average dosage of bunarizine hydrochloride tablets and oxycodone hydrochloride sustained release tablets to titration volume in the observation group was less than that in the control group ( P <0.05). The incidence of adverse reactions was 23.3% (28/120) in the observation group, which was lower than 44.2% (53/120) in the control group ( P <0.05).
CONCLUSION


Filiform fire needling can alleviate pain symptoms of patients with moderate and severe pain in advanced cancer, reduce the amount of analgesics, and decrease the incidence of adverse reactions.",2020,"After treatment, the NRS scores of both groups were lower than those before treatment ( P <0.05), and the reducing degree in the observation group was larger than that in the control group ( P <0.05).","['66 patients with moderate and severe pain in advanced cancer', 'patients with moderate and severe pain in advanced cancer', 'advanced cancer']","['bunarizine hydrochloride tablets and oxycodone hydrochloride', 'Filiform fire needling', 'bucinnazine hydrochloride tablets', 'oxycodone hydrochloride sustained-release tablets', 'filiform fire needling', 'filiform fire needling at  ashi  point, Zusanli (ST 36), Liangqiu (ST 34), Qihai (CV 6), Guanyuan(CV 4), Quchi (LI 11) and Waiguan (TE 5']","['incidence of adverse reactions', 'moderate and severe pain', 'pain symptoms', 'adverse reactions', 'effective rate', 'NRS scores', 'numerical rating scales (NRS) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0282274', 'cui_str': 'Oxycodone hydrochloride'}, {'cui': 'C0332226', 'cui_str': 'Filiform'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0950990', 'cui_str': '1-N-butyryl-4-cinnamylpiperazine hydrochloride'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0655714', 'cui_str': 'TE 5'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",66.0,0.0233146,"After treatment, the NRS scores of both groups were lower than those before treatment ( P <0.05), and the reducing degree in the observation group was larger than that in the control group ( P <0.05).","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Graduate School of Nanjing University of Chinese Medicine, Nanjing 210046, Jiangsu Province, China.'}, {'ForeName': 'Shi-Nian', 'Initials': 'SN', 'LastName': 'Zhang', 'Affiliation': 'Massage Department of Jiangsu Provincial Hospital of TCM.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190531-k0001']
1233,32538010,[Efficacy and mechanism of acupuncture combined with  Tongxieyaofang  for diarrhea-type irritable bowel syndrome of liver depression and spleen deficiency].,"OBJECTIVE


To observe the clinical effect of acupuncture at lower- he  acupoints and front- mu  acupoints combined with  Tongxieyaofang  (TXYF) for diarrhea-type irritable bowel syndrome (IBS-D) of liver depression and spleen deficiency, and to explore its possible mechanism.
METHODS


A total of 123 IBS-D patients with syndrome of liver depression and spleen deficiency were randomly divided into an acupuncture+TXYF group, a TXYF group and a medication group, 41 cases in each group. The patients in TXYF group were treated with oral administration of TXYF, three times a day. The patients in acupuncture+TXYF group were treated with oral administration of TXYF and routine acupuncture at Shangjuxu (ST 37), Tianshu (ST 25), Taichong (LR 3), Sanyinjiao (SP 6) and Zusanli (ST 36), once a day. The patients in medication group were treated with oral administration of pinaverium bromide, 50 mg, three times a day. All the treatment was given for four weeks. The total score of TCM syndrome scale, self-rating anxiety scale (SAS), self-rating depression scale (SDS) scores as well as the expression of calcitonin gene-related peptide (CGRP), vasoactive peptide (VIP) and MAPK signal pathway indicators of ERK1 mRNA and ERK2 mRNA were compared before and after treatment; the clinical effect was also compared.
RESULTS


After treatment, the total score of TCM syndrome scale and SAS and SDS scores in each group were significantly reduced ( P <0.05), and the scores in the acupuncture+TXYF group were lower than those in TXYF group and medication group ( P <0.05). The total effective rate was 87.8% (36/41) in the acupuncture+TXYF group, which was higher than 78.0% (32/41) in the TXYF group and 68.3% (28/41) in the medication group ( P <0.05). After treatment, the levels of CGRP and VIP in each group were decreased ( P <0.05), and the levels in the acupuncture+TXYF group were lower than those in the TXYF group and the medication group ( P <0.05). After treatment, the levels of ERK1 mRNA and ERK2 mRNA in each group were decreased ( P <0.05), and the levels in acupuncture+TXYF group were lower than those in medication group ( P <0.05).
CONCLUSION


The acupuncture at lower- he  acupoints and front- mu  acupoints combined with TXYF could effectively alleviate the clinical symptoms, improve anxiety and depression in IBS-D patients with syndrome of liver depression and spleen deficiency, and its mechanism may be related to regulating the expression of ERK1 mRNA and ERK2 mRNA in MAPK signaling pathway, and reducing the serum levels of CGRP and VIP.",2020,"After treatment, the levels of CGRP and VIP in each group were decreased ( P <0.05), and the levels in the acupuncture+TXYF group were lower than those in the TXYF group and the medication group ( P <0.05).","['123 IBS-D patients with syndrome of liver depression and spleen deficiency', 'diarrhea-type irritable bowel syndrome of liver depression and spleen deficiency']","['acupuncture combined with  Tongxieyaofang', 'acupuncture at lower', 'acupuncture+TXYF', 'oral administration of TXYF and routine acupuncture at Shangjuxu (ST 37), Tianshu (ST 25), Taichong (LR 3), Sanyinjiao (SP 6) and Zusanli', 'oral administration of pinaverium bromide', 'TXYF', 'oral administration of TXYF', 'front- mu  acupoints combined with  Tongxieyaofang  (TXYF']","['total effective rate', 'total score of TCM syndrome scale and SAS and SDS scores', 'total score of TCM syndrome scale, self-rating anxiety scale (SAS), self-rating depression scale (SDS) scores as well as the expression of calcitonin gene-related peptide (CGRP), vasoactive peptide (VIP) and MAPK signal pathway indicators of ERK1 mRNA and ERK2 mRNA', 'levels of ERK1 mRNA and ERK2 mRNA', 'anxiety and depression', 'levels of CGRP and VIP']","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1813433', 'cui_str': 'ST-37'}, {'cui': 'C0626533', 'cui_str': 'SP 6'}, {'cui': 'C0137073', 'cui_str': 'Pinaverium bromide'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0752312', 'cui_str': 'Mitogen-Activated Protein Kinases'}, {'cui': 'C0037080', 'cui_str': 'Signal Pathways'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0082529', 'cui_str': 'Extracellular Signal-Regulated Kinase 1'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",123.0,0.0179067,"After treatment, the levels of CGRP and VIP in each group were decreased ( P <0.05), and the levels in the acupuncture+TXYF group were lower than those in the TXYF group and the medication group ( P <0.05).","[{'ForeName': 'Shan-Shan', 'Initials': 'SS', 'LastName': 'Wang', 'Affiliation': 'Proctology Department, Chongqing Hospital of TCM, Chongqing 400021, China.'}, {'ForeName': 'Xu-Rui', 'Initials': 'XR', 'LastName': 'Wang', 'Affiliation': ""Sichuan Academy of Medical Sciences•Proctology Department, Sichuan Provincial People's Hospital, Chengdu 610072; Affiliated Hospital of Chengdu University of TCM, Chengdu 610000, Sichuan Province.""}, {'ForeName': 'Rui-Yong', 'Initials': 'RY', 'LastName': 'Yang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Chongqing Jiangbei Hospital of TCM.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Proctology Department, Chongqing Hospital of TCM, Chongqing 400021, China.'}, {'ForeName': 'Ming-Yue', 'Initials': 'MY', 'LastName': 'Li', 'Affiliation': 'Affiliated Hospital of Chengdu University of TCM, Chengdu 610000, Sichuan Province.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190818-k0004']
1234,32538011,[Acupuncture at Ciliao (BL 32) for prevention of postpartum urinary retention in elderly parturient women: a randomized controlled trial].,"OBJECTIVE


To explore the preventive effect of acupuncture at Ciliao (BL 32) on postpartum urinary retention as well as the time and volume of the first urination after delivery in elderly parturient women undergoing vaginal delivery.
METHODS


A total of 180 elderly parturient women (≥35 years old) undergoing vaginal delivery were randomly divided into a blank control group, a conditional control group and an observation group, 60 cases in each group. The patients in the blank control group were treated with routine nursing plan; based on the treatment of the blank control group, the patients in the conditional control group were treated with additional intervention measures such as applying hot towel on the bladder and fingers pressing to stimulate urination; based on the treatment of the blank control group, the patients in the observation group were treated with acupuncture at bilateral Ciliao (BL 32) one hour after delivery for 20 min (the acupuncture was given only once). The incidence rate of postpartum urinary retention as well as the time and volume of the first urination among the women without urinary retention were observed; the satisfaction rate of the 3 groups was recorded.
RESULTS


The incidence rate of postpartum urinary retention in the observation group was 5.0% (3/60), which was significantly lower than 26.7% (16/60) in the blank control group ( P <0.01) and 16.7% (10/60) in the conditional control group ( P <0.05); the incidence rate of postpartum urinary retention in the conditional control group was significantly lower than that in the blank control group [16.7% (10/60) vs 26.7%(16/60),  P <0.05]. In the elderly women without urinary retention, the first urination time in the observation group was significantly earlier than that in the blank control group and conditional control group ( P <0.01), and the first urination time in the conditional control group was earlier than that in the blank control group ( P <0.01). The volume of first urination in the observation group was higher than that in the blank control group and the conditional control group ( P <0.05,  P <0.01). The satisfaction rates in the observation group and conditional control group were higher than that in the blank control group ( P <0.01).
CONCLUSION


Acupuncture at Ciliao (BL 32) could effectively prevent the postpartum urinary retention, improve the time and volume of the first urination in elderly parturient women undergoing vaginal delivery.",2020,"The volume of first urination in the observation group was higher than that in the blank control group and the conditional control group ( P <0.05,  P <0.01).","['elderly parturient women', '180 elderly parturient women (≥35 years old) undergoing vaginal delivery', 'elderly parturient women undergoing vaginal delivery']","['acupuncture at Ciliao (BL 32', 'acupuncture at bilateral Ciliao (BL 32) one hour after delivery for 20 min (the acupuncture', 'Acupuncture at Ciliao (BL 32', 'routine nursing plan', 'additional intervention measures such as applying hot towel on the bladder and fingers pressing to stimulate urination']","['first urination time', 'time and volume of the first urination', 'satisfaction rate', 'volume of first urination', 'satisfaction rates', 'postpartum urinary retention', 'incidence rate of postpartum urinary retention']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0336616', 'cui_str': 'Towel'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}]","[{'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",180.0,0.0181422,"The volume of first urination in the observation group was higher than that in the blank control group and the conditional control group ( P <0.05,  P <0.01).","[{'ForeName': 'Shao-Fei', 'Initials': 'SF', 'LastName': 'Gu', 'Affiliation': 'Department of TCM, First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui Province, China.'}, {'ForeName': 'Ming-Qiang', 'Initials': 'MQ', 'LastName': 'Li', 'Affiliation': 'Department of TCM, First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui Province, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of TCM, First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui Province, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'No. 31 Inpatient Ward, First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui Province, China.'}, {'ForeName': 'Ling-Li', 'Initials': 'LL', 'LastName': 'Han', 'Affiliation': 'Department of Gynecology and Obstetrics, First Affiliated Hospital of Wannan Medical College, Wuhu 241000, Anhui Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190528-k0005']
1235,32538012,[Effect of transcutaneous electrical acupoint stimulation on labor analgesia].,"OBJECTIVE


To observe the effect of transcutaneous electrical acupoint stimulation (TEAS) on labor pain.
METHODS


A total of 151 primiparas who were vaginal delivery were randomized into a TEAS group (76 cases) and a peridural group (75 cases). In the peridural group, peridural blockage was applied to analgesia. In the TEAS group, TEAS was applied at Hegu (LI 4)，Neiguan (PC 6), Jiaji T 10 ~L 1  (EX-B 2) and Ciliao (BL 32), disperse-dense wave (2 Hz/100 Hz), 15-50 mA in current intensity. The analgesic time was from 3 cm to completely opening of cervix. The visual analogue scale (VAS) scores were observed before analgesia, after 30, 60, 120 min of analgesia in the two groups. The time of different stages of labor, usage rate of oxytocin, incidence rate of adverse reaction and amount of postpartum hemorrhage were recorded. The newborn's 1 and 5 min Apgar scores were evaluated.
RESULTS


The VAS scores showed a downward trend in the two groups after analgesia ( P <0.01), and the change of the TEAS group was less than the peridural group ( P <0.01). The active phase on the first stage and second stage of labor in the TEAS group were shorter than the peridural group ( P <0.01,  P <0.05), there was no significant difference in the time of third stage of labor between the two groups ( P >0.05). The usage rate of oxytocin and incidence rate of adverse reaction in the TEAS group were 9.2% (7/76) and 2.6% (2/76), which were lower than 34.7% (26/75) and 18.7% (14/75) in the peridural group ( P <0.01). There was no significant difference in the amount of postpartum hemorrhage and newborn's 1 and 5 min Apgar scores between the two groups ( P >0.05).
CONCLUSION


The analgesic effect of TEAS is inferior to peridural blockage, but TEAS could relieve labor pain to the tolerance, shorten the time of active phase on the first stage and second stage of labor and reduce the use of oxytocin, has mild adverse reaction.",2020,"There was no significant difference in the amount of postpartum hemorrhage and newborn's 1 and 5 min Apgar scores between the two groups ( P >0.05).
",['151 primiparas who were vaginal delivery'],"['TEAS', 'oxytocin', 'transcutaneous electrical acupoint stimulation', 'transcutaneous electrical acupoint stimulation (TEAS']","[""newborn's 1 and 5 min Apgar scores"", 'Jiaji T 10 ~L 1  (EX-B 2) and Ciliao (BL 32', 'visual analogue scale (VAS) scores', 'analgesic time', 'labor analgesia', 'time of third stage of labor', ""amount of postpartum hemorrhage and newborn's 1 and 5 min Apgar scores"", 'labor pain', 'usage rate of oxytocin and incidence rate of adverse reaction', 'time of different stages of labor, usage rate of oxytocin, incidence rate of adverse reaction and amount of postpartum hemorrhage', 'VAS scores']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0045550', 'cui_str': '2,5-dichloro-4-bromophenol'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1301740', 'cui_str': 'Analgesia in labor'}, {'cui': 'C0022873', 'cui_str': 'Third stage of labor'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",151.0,0.0337001,"There was no significant difference in the amount of postpartum hemorrhage and newborn's 1 and 5 min Apgar scores between the two groups ( P >0.05).
","[{'ForeName': 'Wei-Juan', 'Initials': 'WJ', 'LastName': 'Miao', 'Affiliation': ""Department of Obstetrics, Affiliated Hospital of Qingdao University, Qingdao 266000, Shandong Province, China; Department of Obstetrics, People's Hospital of Rizhao, Rizhao 276800, Shandong Province.""}, {'ForeName': 'Wei-Hong', 'Initials': 'WH', 'LastName': 'Qi', 'Affiliation': 'Department of Obstetrics, Affiliated Hospital of Qingdao University, Qingdao 266000, Shandong Province, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics, People's Hospital of Rizhao, Rizhao 276800, Shandong Province.""}, {'ForeName': 'Xiang-Lan', 'Initials': 'XL', 'LastName': 'Song', 'Affiliation': ""Department of Obstetrics, People's Hospital of Rizhao, Rizhao 276800, Shandong Province.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics, People's Hospital of Rizhao, Rizhao 276800, Shandong Province.""}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': ""Department of Obstetrics, People's Hospital of Rizhao, Rizhao 276800, Shandong Province.""}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190824-0001']
1236,32539432,The Effects of an Online Training on Preservice Speech-Language Pathologists' Use of Family-Centered Skills.,"Purpose Despite the recognition that family-centered services are best practice in augmentative and alternative communication services, many speech-language pathologists (SLPs) are lacking in their acquisition and implementation of family-centered skills. The purpose of this study was to evaluate the effects of online instruction in a family-centered, relational skills strategy on preservice SLPs use of family-centered skills. Method A switching replications design was used to evaluate the effects of an online training on the use of family-centered behaviors by 15 preservice SLPs who were randomly assigned to two groups. The online training taught the students a four-step relational skills strategy (summarized by the acronym LAFF): (a) Listen, empathize, and communicate respect; (b) Ask questions; (c) Focus on the issues; and (d) Find a first step. Participants were videotaped during interactions with simulated parents before and after the training. Results After an average of 61 min of instruction via the online module, all of the preservice SLPs significantly improved their demonstration of relational skills. Additionally, one parent of a child who used augmentative and alternative communication viewed the video recordings and chose 14 of the 15 postinstruction role plays as more family-centered. Conclusion The findings from this study provide support for the use of an online environment to teach preservice SLPs family-centered relational skills. In order to prepare future SLPs and ensure the delivery of family-centered services, future research is necessary, including investigations to determine whether other family-centered skills can be effectively taught through an online environment. Supplemental Material https://doi.org/10.23641/asha.12462344.",2020,"After an average of 61 min of instruction via the online module, all of the preservice SLPs significantly improved their demonstration of relational skills.","[""Preservice Speech-Language Pathologists' Use of Family-Centered Skills"", 'family-centered behaviors by 15 preservice SLPs']","['online instruction', 'online training', 'Supplemental Material https://doi.org/10.23641/asha.12462344', 'Online Training', 'online training taught the students a four-step relational skills strategy (summarized by the acronym LAFF): (a) Listen, empathize, and communicate respect']",['demonstration of relational skills'],"[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0334866', 'cui_str': 'Medical pathologist'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1956259', 'cui_str': 'Acronyms'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0679133', 'cui_str': 'Respect'}]",[],,0.0160661,"After an average of 61 min of instruction via the online module, all of the preservice SLPs significantly improved their demonstration of relational skills.","[{'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Mandak', 'Affiliation': 'Department of Communication Sciences and Disorders, The Pennsylvania State University, State College.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Light', 'Affiliation': 'Department of Communication Sciences and Disorders, The Pennsylvania State University, State College.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McNaughton', 'Affiliation': 'Department of Educational Psychology, Counseling, and Special Education, The Pennsylvania State University, State College.'}]",American journal of speech-language pathology,['10.1044/2020_AJSLP-19-00057']
1237,32540634,"A randomized, double blind, placebo controlled study to evaluate the effects of ashwagandha (Withania somnifera) extract on sleep quality in healthy adults.","OBJECTIVE


Non-restorative sleep (NRS) affects 10% people worldwide, leading to poor sleep quality, as well as physical and cognitive fatigue. This is the first human study in which an extract of ashwagandha (Withania somnifera Dunal L.) was evaluated for effects in improving overall sleep quality in subjects with NRS.
METHODS


In this randomized, double-blind, placebo-controlled trial, 150 healthy subjects scoring high on non-restorative sleep measures were given 120 mg of standardized ashwagandha extract (Shoden®) once daily for six weeks. Subjects were evaluated using the Restorative Sleep Questionnaire-weekly version and World Health Organization Quality of Life-Bref (WHOQOL) scale. Sleep actigraphy was used to measure the onset of sleep latency, sleep efficiency, total sleep time and wake after sleep onset. Safety of the treatment was determined by testing of vitals, hematology, biochemistry and urinalysis.
RESULTS


A total of 144 subjects completed the study, with no dropouts due to adverse events. A 72% increase in self-reported sleep quality was found for the treatment group, compared with 29% in the placebo group (p < 0.001). Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks. In the ashwagandha group quality of life (QOL) scores showed significant improvement in physical (p < 0.001), psychological (p < 0.001), and environment domains (p < 0.01).
CONCLUSIONS


Supplementation with the standardized ashwagandha extract for six weeks improved the overall quality of sleep by significantly improving the NRS condition in healthy subjects. No treatment related adverse events were reported in the study.
TRIAL REGISTRATION


Clinical Trials Registry-India (www.ctri.nic.in). Registration number: CTRI/2017/02/007801.",2020,"Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks.","['subjects with NRS', 'healthy subjects', 'healthy adults', '150 healthy subjects scoring high on non-restorative sleep measures', '144 subjects completed the study, with no dropouts due to adverse events']","['standardized ashwagandha extract (Shoden®', 'ashwagandha (Withania somnifera) extract', 'placebo']","['Sleep actigraphy', 'Restorative Sleep Questionnaire-weekly version and World Health Organization Quality of Life-Bref (WHOQOL) scale', 'total sleep time', 'overall quality of sleep', 'onset of sleep latency, sleep efficiency, total sleep time and wake after sleep onset', 'overall sleep quality', 'sleep latency', 'adverse events', 'quality of life (QOL) scores', 'sleep quality', 'self-reported sleep quality', 'sleep efficiency (SE']","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C1061163', 'cui_str': 'Withania somnifera'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",150.0,0.234196,"Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks.","[{'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Deshpande', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India. Electronic address: abhijitd1965@gmail.com.'}, {'ForeName': 'Nushafreen', 'Initials': 'N', 'LastName': 'Irani', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India.'}, {'ForeName': 'Ratna', 'Initials': 'R', 'LastName': 'Balkrishnan', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India.'}, {'ForeName': 'Irin Rosanna', 'Initials': 'IR', 'LastName': 'Benny', 'Affiliation': 'Amala Institute of Medical Sciences, Amala Nagar PO, Thrissur, Kerala, 680555, India.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.012']
1238,32534731,[Pulse pressure variation guided fluid therapy during kidney transplantation: a randomized controlled trial].,"PURPOSE


Kidney transplantation is the gold-standard treatment for end stage renal disease. Although different hemodynamic variables, like central venous pressure and mean arterial pressure, have been used to guide volume replacement during surgery, the best strategy still ought to be determined. Respiratory arterial Pulse Pressure Variation (PPV) is recognized to be a good predictor of fluid responsiveness for perioperative hemodynamic optimization in operating room settings. The aim of this study was to investigate whether a PPV-guided fluid management strategy is better than a liberal fluid strategy during kidney transplantation surgeries. Identification of differences in urine output in the first postoperative hour was the main objective of this study.
METHODS


We conducted a prospective, single blind, randomized controlled trial. We enrolled 40 patients who underwent kidney transplantation from deceased donors. Patients randomized in the PPV Group received fluids whenever PPV was higher than 12%, patients in the Free Fluid Group received fluids following our institutional standard care protocol for kidney transplantations (10mL.kg -1 .h -1 ).
RESULTS


Urinary output was similar at every time-point between the two groups, urea was statistically different from the third postoperative day with a peak at the fourth postoperative day and creatinine showed a similar trend, being statistically different from the second postoperative day. Urea, creatinine and urine output were not different at the hospital discharge.
CONCLUSION


PPV-guided fluid therapy during kidney transplantation significantly improves urea and creatinine levels in the first week after kidney transplantation surgery.",2020,"RESULTS


Urinary output was similar at every time-point between the two groups, urea was statistically different from the third postoperative day with a peak at the fourth postoperative day and creatinine showed a similar trend, being statistically different from the second postoperative day.","['40 patients who underwent kidney transplantation from deceased donors', 'kidney transplantation surgeries', 'kidney transplantation']","['Pulse pressure variation guided fluid therapy', 'PPV', 'PPV-guided fluid management strategy']","['Urinary output', 'Urea, creatinine and urine output', 'urea and creatinine levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}]","[{'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}]",40.0,0.343157,"RESULTS


Urinary output was similar at every time-point between the two groups, urea was statistically different from the third postoperative day with a peak at the fourth postoperative day and creatinine showed a similar trend, being statistically different from the second postoperative day.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'De Cassai', 'Affiliation': 'University of Padova, Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, Padova, Itália. Electronic address: alessandro.decassai@gmail.com.'}, {'ForeName': 'Ottavia', 'Initials': 'O', 'LastName': 'Bond', 'Affiliation': 'University of Padova, Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, Padova, Itália.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Marini', 'Affiliation': 'University of Padova, Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, Padova, Itália.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Panciera', 'Affiliation': 'University of Padova, Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, Padova, Itália.'}, {'ForeName': 'Lucrezia', 'Initials': 'L', 'LastName': 'Furian', 'Affiliation': 'Padua University Hospital, Department of Surgery, Oncology and Gastroenterology, Kidney and Pancreas Transplant Unit, Pádua, Itália.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Neri', 'Affiliation': 'Padua University Hospital, Department of Surgery, Oncology and Gastroenterology, Kidney and Pancreas Transplant Unit, Pádua, Itália.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Andreatta', 'Affiliation': 'University of Padova, Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, Padova, Itália.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Rigotti', 'Affiliation': 'Padua University Hospital, Department of Surgery, Oncology and Gastroenterology, Kidney and Pancreas Transplant Unit, Pádua, Itália.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Feltracco', 'Affiliation': 'University of Padova, Department of Medicine - DIMED, Section of Anesthesiology and Intensive Care, Padova, Itália.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.02.008']
1239,32543161,Therapeutic effect of inhaled budesonide in transient tachypnea of newborn: A placebo-controlled study.,"Transient tachypnea of the newborn (TTN) is a chest disease found in neonates. It varies from mild to severe and is accompanied by neonatal morbidity and respiratory complications. This is a prospective placebo-controlled study, identification number is TCTR20200513005, which was done in the neonatal unit of Tanta University Hospital between June 2016 and March 2018. This study comprised 100 neonates with TTN, which were divided into two groups. The first group (inhaled steroid group) consisted of 50 neonates with TTN who were exposed to inhalation of corticosteroids (budesonide 2 ml, 0.25 mg/ml suspension for nebulizer, AstraZeneca AB, Södertälje, Sweden), the first dose was administered within 6 h of birth and the second dose was given 12 h later. The second group (placebo group) consisted of 50 neonates with TTN who were exposed to placebo inhalation (2 ml of distilled sterile water). There was significant difference between both groups regarding Down score (P = 0.001), TTN clinical score (P = 0.001) and Saturation of Peripheral Oxygen (SpO 2 ) measured by pulse oximeter (P = 0.008), while there was nonsignificant difference between both groups regarding PH (P = 0.573), and this showed that clinically the inhaled steroid group is significantly better than the placebo group. Hence, this study concludes that since administration of inhaled budesonide showed improvement in TTN cases, it could be a recommended line of treatment for neonatal TTN.",2020,"There was significant difference between both groups regarding Down score (P = 0.001), TTN clinical score (P = 0.001) and Saturation of Peripheral Oxygen (SpO 2 ) measured by pulse oximeter (P = 0.008), while there was nonsignificant difference between both groups regarding PH (P = 0.573), and this showed that clinically the inhaled steroid group is significantly better than the placebo group.","['neonatal unit of Tanta University Hospital between June 2016 and March 2018', 'group) consisted of 50 neonates with TTN who were exposed to', '50 neonates with TTN who were exposed to inhalation of corticosteroids ', '100 neonates with TTN', 'transient tachypnea of newborn']","['inhaled budesonide', 'placebo inhalation', 'budesonide', 'placebo']","['TTN clinical score', 'Saturation of Peripheral Oxygen (SpO 2 ) measured by pulse oximeter', 'Transient tachypnea of the newborn (TTN']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0158940', 'cui_str': 'Transitory tachypnea of newborn'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0158940', 'cui_str': 'Transitory tachypnea of newborn'}]",50.0,0.114148,"There was significant difference between both groups regarding Down score (P = 0.001), TTN clinical score (P = 0.001) and Saturation of Peripheral Oxygen (SpO 2 ) measured by pulse oximeter (P = 0.008), while there was nonsignificant difference between both groups regarding PH (P = 0.573), and this showed that clinically the inhaled steroid group is significantly better than the placebo group.","[{'ForeName': 'Mohamed Shawky', 'Initials': 'MS', 'LastName': 'Elfarargy', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Tanta University, Tanta, Egypt; farargy2009@hotmail.com.'}, {'ForeName': 'Sally El-Sayed', 'Initials': 'SE', 'LastName': 'Abu-Risha', 'Affiliation': 'Department of Pharmacology & Toxicology, Faculty of Pharmacy, Tanta University, Egypt.'}, {'ForeName': 'Reham Lotfy', 'Initials': 'RL', 'LastName': 'Younis', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Journal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique,['10.15586/jptcp.v27i2.663']
1240,32535342,Food intake is associated with verbal interactions between nursing home staff and residents with dementia: A secondary analysis of videotaped observations.,"BACKGROUND


Nursing home residents with dementia commonly experience low food intake, leading to negative functional and nutritional consequences. While the importance of staff-resident (dyadic) interactions during mealtime is acknowledged, little research has examined the role of dyadic verbal interactions on food intake.
OBJECTIVES


This study aimed to examine the relationship between food intake and dyadic verbal interactions.
METHODS


This study was a secondary analysis of 110 videotaped observations of mealtime care interactions among 25 residents with dementia and 29 staff (42 unique dyads) in 9 nursing homes. Staff positive utterances and resident positive and negative utterances (independent variables) and food intake (dependent variable) were coded from the videotaped observations using the Cue Utilization and Engagement in Dementia video coding scheme. A linear mixed model was fit to the data. The two-way interaction effects of food type and video duration with each independent variable as well as two-way interaction effects among the independent variables were tested. Covariates included in the model were the number of years staff worked as a caregiver, and resident age, gender, and eating function.
RESULTS


The model included three significant interaction effects involving verbal variables: the interaction effect of staff positive utterances with resident positive utterances (p=.030), the interaction effect of staff positive utterances with food type (p=.027), and the interaction effect of resident negative utterances with video duration (p=0.002). Increased number of intakes of liquid food per minute was associated with increased number of staff positive utterances per minute when residents did not make positive utterances. Decreased number of intakes of solid food per minute was associated with increased number of staff positive utterances per minute, especially when residents made between 0 and 3 positive utterances per minute. As the duration of the videos increased, the number of intakes per minute increased for residents who made one or more negative utterances and decreased for residents who made no negative utterances in the videos. The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics.
CONCLUSION


Intake was associated with dyadic verbal interactions, and such relationship was complex in that it was moderated by food type and video duration. Findings support the significant role of dyadic verbal interactions on intake, and inform the development of effective, tailored mealtime care interventions to promote intake.",2020,"The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics.
","['25 residents with dementia and 29 staff (42 unique dyads) in 9 nursing homes', 'nursing home staff and residents with dementia']",[],"['number of intakes per minute', 'dyadic verbal interactions', 'Staff positive utterances and resident positive and negative utterances (independent variables) and food intake', 'number of staff positive utterances']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0013470', 'cui_str': 'Eating'}]",110.0,0.0676015,"The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics.
","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA. Electronic address: wen-liu-1@uiowa.edu.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Perkhounkova', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'The University of Kansas, School of Nursing, Kansas City, KS, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Batchelor', 'Affiliation': 'George Washington University, School of Nursing, Washington, D.C., USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103654']
1241,32535407,An investigation of the impact of social exclusion on attachment to possessions and saving behaviors.,"BACKGROUND AND OBJECTIVES


Hoarding disorder (HD) is a debilitating mental illness characterized by extreme difficulty parting with possessions and clutter that can result in dangerous living conditions. One hypothesis about why individuals with HD save possessions is that they possess a pathological attachment to their belongings, which may serve to compensate for unfulfilling interpersonal relationships. However, there is a dearth of empirical work examining this. The current study examined the impact of an experimental manipulation of social exclusion on attachment to possessions and saving behaviors in a sample of individuals with elevated hoarding symptoms.
METHODS


Participants (n = 117) were selected for scoring above the non-clinical mean on a measure of hoarding symptoms. Participants were randomized to either be included or excluded in a game of Cyberball. They completed a behavioral discarding task and object attachment measure before and after completion of the game.
RESULTS


Study condition was unrelated to in vivo attachment to possessions and saving behaviors during the discarding task. However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task.
LIMITATIONS


Limitations include the use of a non-clinical and homogeneous sample.
CONCLUSIONS


Taken together, individuals prone to feelings of rejection may be at risk for developing HD as they may use possessions to cope with interpersonal stress. Results will be discussed in light of implications for theoretical models and potential treatment targets in HD.",2020,"However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task.
","['individuals with elevated hoarding symptoms', 'Participants (n\xa0=\xa0117']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],[],117.0,0.034374,"However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task.
","[{'ForeName': 'Brittany M', 'Initials': 'BM', 'LastName': 'Mathes', 'Affiliation': 'Florida State University, United States.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Florida State University, United States. Electronic address: schmidt@psy.fsu.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101588']
1242,32683489,A brief bout of exercise in hypoxia reduces ventricular filling rate and stroke volume response during muscle metaboreflex activation.,"PURPOSE


The hemodynamic consequences of exercise in hypoxia have not been completely investigated. The present investigation aimed at studying the hemodynamic effects of contemporary normobaric hypoxia and metaboreflex activation.
METHODS


Eleven physically active, healthy males (age 32.7 ± 7.2 years) completed a cardiopulmonary test on an electromagnetically braked cycle-ergometer to determine their maximum workload (W max ). On separate days, participants performed two randomly assigned exercise sessions (3 minutes pedalling at 30% of W max ): (1) one in normoxia (NORMO), and (2) one in normobaric hypoxia with FiO 2  set to 13.5% (HYPO). After each session, the following protocol was randomly assigned: either (1) post-exercise muscle ischemia (PEMI) to study the metaboreflex, or (2) a control exercise recovery session, i.e., without metaboreflex activation. Hemodynamics were assessed with impedance cardiography.
RESULTS


The main result was that the HYPO session impaired the ventricular filling rate (measured as stroke volume/diastolic time) response during PEMI versus control condition in comparison to the NORMO test (31.33 ± 68.03 vs. 81.52 ± 49.23 ml·s -1 ,respectively, p = 0.003). This caused a reduction in the stroke volume response (1.45 ± 9.49 vs. 10.68 ± 8.21 ml, p = 0.020). As a consequence, cardiac output response was impaired during the HYPO test.
CONCLUSIONS


The present investigation suggests that a brief exercise bout in hypoxia is capable of impairing cardiac filling rate as well as stroke volume during the metaboreflex. These results are in good accordance with recent findings showing that among hemodynamic modulators, ventricular filling is the most sensible variable to hypoxic stimuli.",2020,"This caused a reduction in the stroke volume response (1.45 ± 9.49 vs. 10.68 ± 8.21 ml, p = 0.020).","['Eleven physically active, healthy males (age 32.7\u2009±\u20097.2\xa0years) completed a']","['post-exercise muscle ischemia (PEMI) to study the metaboreflex, or (2) a control exercise recovery session, i.e., without metaboreflex activation', 'cardiopulmonary test on an electromagnetically braked cycle-ergometer to determine their maximum workload (W max ', 'exercise sessions (3 minutes pedalling at 30% of W max ): (1) one in normoxia (NORMO), and (2) one in normobaric hypoxia with FiO 2  set to 13.5% (HYPO']","['stroke volume/diastolic time) response', 'cardiac output response', 'ventricular filling rate', 'stroke volume response']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337108', 'cui_str': 'Brake'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C4517559', 'cui_str': '13.5'}]","[{'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}]",11.0,0.067047,"This caused a reduction in the stroke volume response (1.45 ± 9.49 vs. 10.68 ± 8.21 ml, p = 0.020).","[{'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Mulliri', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Magnani', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Silvana', 'Initials': 'S', 'LastName': 'Roberto', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Sechi', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Ghiani', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Gianmarco', 'Initials': 'G', 'LastName': 'Sainas', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Nughedu', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy.'}, {'ForeName': 'Seyed Alireza', 'Initials': 'SA', 'LastName': 'Hosseini Kakhak', 'Affiliation': 'Faculty of Physical Education and Sport Sciences, Hakim Sabzevari University, Sabzevar, Iran.'}, {'ForeName': 'Pier Paolo', 'Initials': 'PP', 'LastName': 'Bassareo', 'Affiliation': 'University College of Dublin, Mater Misericordiae University Teaching Hospital, Dublin, Ireland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Crisafulli', 'Affiliation': 'Sports Physiology Laboratory, Department of Medical Sciences and Public Health, University of Cagliari, Via Porcell 4, 09124, Cagliari, Italy. crisafulli@tiscali.it.'}]",European journal of applied physiology,['10.1007/s00421-020-04435-0']
1243,32573156,[Evaluation of therapeutic effects of the ultramicro needle knife combined with cervical spine fine adjusting on youth cervical curvature abnormality case].,"OBJECTIVE


To study the therapeutic effects of the ultramicro needle-knife combine with cervical spine fine adjusting on youth cervical curvature abnormality case.
METHODS


From November 2016 to October 2018, 88 young patients with abnormal curvature of cervical spine were treated. Due to loss of follow up, 86 cases were actually completely including 37 males and 49 females, ranging in age from 20 to 40 years old, with an average of (30.55±5.21) years old, and the course of disease ranged from 1 to 42 months, with a mean of (14.21±7.38) months. All the patients were divided into two groups:treatment group (44 cases) and control group (42 cases). The patients in the treatment group were treated with ultramicro needle-knife and cervical spine fine adjusting, and the patients in the control group were treated with conventional acupuncture and manipulation. The treatments were done 1 time per week in the treatment group while 3 times per week in control group every week, with a duration of 3 weeks for both groups. Before treatment, 3 weeks after treatment, and at the end of 1 month follow-up, the score of neck pain questionnaire(NPQ), range of the motion(ROM) in the cervical region and the D values of cervical physiological curvature were recorded. The efficacy at the end of treatment and in the follow up was evaluated. During the treatment, the patients were also required to correct the bad posture in daily life, to sleep in a low pillow position, and put a moderately columnar pillow behind the neck for 0.5 hours every morning and evening.
RESULTS


Two patients in the control group were dropped out after 3 weeks treatment. No adverse reactions were found in the 2 groups during the treatment period. Compared with those before treatment, all scores at all the observation time points were significantly improved between two groups after treatment(all  P <0.05). The NPQ scores of cervical symptoms were different significantly between two groups(all  P <0.05). The changing range of the the NPQ score of cervical symptoms and cervical spine alignment curve of the treatment group were better than those of the control group ( P <0.05).There was statistical difference in NPQ scores between different time points, in the other words, there was time effect( F =203.63,  P =0.000). There was interaction between time factor and group factor( F =4.964,  P =0.012). There was no statistical difference in the changing range of the ROM score between two groups (all  P >0.05). There was statistical difference in ROM scores between different time points, there was time effect ( F =240.32),  P =0.000). There was no interaction between time factor and group factor ( F =0.311,  P =0.734). The effective rate of the treatment group and control group were 90.91%(40 / 44) and 80.95%(34 / 42) respectively, the treatment group was more effective than the control group ( P <0.05). During the follow-up period, the effective rate of the treatment group and the control group were 84.09%(37 / 44) and 76.19%(32 / 42) respectively. Obviously, the difference of total effective rate between two groups had no statistical signification( P >0.05) in the follow-up duration.
CONCLUSION


The method of needle knife combined with cervical spine fine adjusting has a better therapeutic efficiency than conventional acupuncturecombined with manipulation in treating youth cervical curvature abnormality patients. Because this novel method can recover the cervical curvature, relieve the neck pain, and improve cervical mobility.",2020,There was no statistical difference in the changing range of the ROM score between two groups (all  P >0.05).,"['86 cases were actually completely including 37 males and 49 females, ranging in age from 20 to 40 years old, with an average of (30.55±5.21) years old, and the course of disease ranged from 1 to 42 months, with a mean of (14.21±7.38) months', 'youth cervical curvature abnormality case', 'youth cervical curvature abnormality patients', 'From November 2016 to October 2018, 88 young patients with abnormal curvature of cervical spine were treated']","['conventional acupuncturecombined with manipulation', 'conventional acupuncture and manipulation', 'ultramicro needle-knife and cervical spine fine adjusting', 'needle knife combined with cervical spine fine adjusting', 'ultramicro needle knife combined with cervical spine fine adjusting', 'ultramicro needle-knife combine with cervical spine fine adjusting']","['NPQ scores of cervical symptoms', 'total effective rate', 'NPQ score of cervical symptoms and cervical spine alignment curve', 'score of neck pain questionnaire(NPQ), range of the motion(ROM) in the cervical region and the D values of cervical physiological curvature', 'effective rate', 'ROM scores', 'adverse reactions', 'ROM score', 'observation time points', 'NPQ scores']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0333063', 'cui_str': 'Abnormal curvature'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0181464', 'cui_str': 'Needle knife'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",88.0,0.0154139,There was no statistical difference in the changing range of the ROM score between two groups (all  P >0.05).,"[{'ForeName': 'Hai-Ping', 'Initials': 'HP', 'LastName': 'Hong', 'Affiliation': 'Fangta Hospital of Traditional Chinese Medicine, Songjiang Branch, Shanghai 201699, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Fangta Hospital of Traditional Chinese Medicine, Songjiang Branch, Shanghai 201699, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Zhong', 'Affiliation': 'Fangta Hospital of Traditional Chinese Medicine, Songjiang Branch, Shanghai 201699, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Fangta Hospital of Traditional Chinese Medicine, Songjiang Branch, Shanghai 201699, China.'}, {'ForeName': 'Yu-Yun', 'Initials': 'YY', 'LastName': 'Xu', 'Affiliation': 'Fangta Hospital of Traditional Chinese Medicine, Songjiang Branch, Shanghai 201699, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.06.007']
1244,32570661,Preliminary Results from a Pragmatic Clinical Trial of MyPEEPS Mobile to Improve HIV Prevention Behaviors in Young Men.,Our study team developed the MyPEEPS Mobile App for improving HIV prevention behaviors in diverse young men. We conducted a randomized controlled trial and evaluated the preliminary outcomes in the first half (N=350) of our intended study sample. Higher self-efficacy for HIV prevention behaviors (p=0.0042) and more recent HIV tests in the past 3 months (p=0.0156) were reported by the intervention group compared to control. Numbers of condomless anal sex acts were lower among the intervention group for both insertive anal sex acts (p=0.0283) and receptive anal sex acts (p=0.0001). Preliminary results indicate that some sexual risk behaviors were reduced among the intervention group in the preliminary analytic sample.,2020,Numbers of condomless anal sex acts were lower among the intervention group for both insertive anal sex acts (p=0.0283) and receptive anal sex acts (p=0.0001).,"['diverse young men', 'Young Men']","['MyPEEPS Mobile', 'MyPEEPS Mobile App']","['HIV Prevention Behaviors', 'Numbers of condomless anal sex acts', 'receptive anal sex acts', 'sexual risk behaviors', 'HIV prevention behaviors']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0282347', 'cui_str': 'Anal sex'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0422696,Numbers of condomless anal sex acts were lower among the intervention group for both insertive anal sex acts (p=0.0283) and receptive anal sex acts (p=0.0001).,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Schnall', 'Affiliation': 'Columbia University School of Nursing, NY, NY USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kuhns', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Pearson', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Birmingham AIDS Outreach, Birmingham, AL, USA.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Batey', 'Affiliation': 'University of Alabama Birmingham, AL, USA.'}, {'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Radix', 'Affiliation': 'Callen Lorde Community Health Center, NY, NY, USA.'}, {'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Belkind', 'Affiliation': 'Callen Lorde Community Health Center, NY, NY, USA.'}, {'ForeName': 'Marco A', 'Initials': 'MA', 'LastName': 'Hidalgo', 'Affiliation': ""Children's Hospital of Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Hirshfield', 'Affiliation': 'SUNY Downstate Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Ganzhorn', 'Affiliation': 'Columbia University School of Nursing, NY, NY USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Garofalo', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.""}]",Studies in health technology and informatics,['10.3233/SHTI200444']
1245,32570678,Strengthening Behavior and Social Functioning Among Persons with Autism Spectrum Conditions Using Artificial Intelligence and Behavioral Activation: Protocol for the Well-Being and Health for Loved onEs with ASD (WHOLE) Psychosocial Pilot Randomized Controlled Trial.,"Although a proportion of families and communities in low resource settings continue to provide care to loved ones with autism spectrum conditions, many of the affected persons remain undiagnosed and without access to proven therapies due to high treatment cost and cultural pressures, in particular. Use of conversational agents on mobile phones in combination with behavior activation home care may provide an innovative, culturally appropriate and affordable platform for strengthening behavior and social functioning outcomes, in addition to an opportunity for participation of the persons with autism spectrum conditions in the intervention development process. We aim to assess the effectiveness of an intervention that incorporates artificial intelligence conversational agent technologies and behavioral activation therapy techniques.",2020,"Use of conversational agents on mobile phones in combination with behavior activation home care may provide an innovative, culturally appropriate and affordable platform for strengthening behavior and social functioning outcomes, in addition to an opportunity for participation of the persons with autism spectrum conditions in the intervention development process.",['Persons with Autism'],['conversational agents'],['Strengthening Behavior and Social Functioning'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",,0.0422117,"Use of conversational agents on mobile phones in combination with behavior activation home care may provide an innovative, culturally appropriate and affordable platform for strengthening behavior and social functioning outcomes, in addition to an opportunity for participation of the persons with autism spectrum conditions in the intervention development process.","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bowrin', 'Affiliation': 'Global Health and Health Security Doctoral Program, College of Public Health, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Iqbal', 'Affiliation': 'Global Health and Health Security, College of Public Health, Taipei Medical University, Taipei, Taiwan.'}]",Studies in health technology and informatics,['10.3233/SHTI200461']
1246,32571859,"The EX-FRAIL CKD trial: a study protocol for a pilot randomised controlled trial of a home-based EXercise programme for pre-frail and FRAIL, older adults with Chronic Kidney Disease.","INTRODUCTION


Frailty is highly prevalent in adults with chronic kidney disease (CKD) and is associated with adverse health outcomes including falls, poorer health-related quality of life (HRQOL), hospitalisation and mortality. Low physical activity and muscle wasting are important contributors to physical frailty in adults with CKD. Exercise training may improve physical function and frailty status leading to associated improvements in health outcomes, including HRQOL. The EX-FRAIL CKD trial aims to inform the design of a definitive randomised controlled trial (RCT) that investigates the effectiveness of a progressive, multicomponent home-based exercise programme in prefrail and frail older adults with CKD.
METHODS AND ANALYSIS


The EX-FRAIL CKD trial is a two-arm parallel group pilot RCT. Participants categorised as prefrail or frail, following Frailty Phenotype (FP) assessment, will be randomised to receive exercise or usual care. Participants randomised to the intervention arm will receive a tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression. Primary feasibility outcome measures include rate of recruitment, intervention adherence, outcome measure completion and participant attrition. Semistructured interviews with a purposively selected group of participants will inform the feasibility of the randomisation procedures, outcome measures and intervention. Secondary outcome measures include physical function (walking speed and Short Physical Performance Battery), frailty status (FP), fall concern (Falls Efficacy Scale-International tool), activities of daily living (Barthel Index), symptom burden (Palliative care Outcome Scale-Symptoms RENAL) and HRQOL (Short Form-12v2).
ETHICS AND DISSEMINATION


Ethical approval was granted by a National Health Service (NHS) Regional Ethics Committee and the NHS Health Research Authority. The study team aims to publish findings in a peer-reviewed journal and presents the results at relevant national and international conferences. A summary of findings will be provided to participants, a local kidney patient charity and the funding body.
TRIAL REGISTRATION NUMBER


ISRCTN87708989.",2020,"Participants randomised to the intervention arm will receive a tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression.","['adults with chronic kidney disease (CKD', 'Participants categorised as prefrail or frail, following Frailty Phenotype (FP) assessment', 'pre-frail and FRAIL, older adults with Chronic Kidney Disease', 'adults with CKD', 'prefrail and frail older adults with CKD']","['multicomponent home-based exercise programme', 'home-based EXercise programme', 'Exercise training', 'exercise or usual care', 'tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression']","['physical function (walking speed and Short Physical Performance Battery), frailty status (FP), fall concern (Falls Efficacy Scale-International tool), activities of daily living (Barthel Index), symptom burden (Palliative care Outcome Scale-Symptoms RENAL) and HRQOL (Short Form-12v2', 'rate of recruitment, intervention adherence, outcome measure completion and participant attrition', 'quality of life (HRQOL), hospitalisation and mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.149749,"Participants randomised to the intervention arm will receive a tailored 12-week exercise programme, which includes weekly telephone calls to advise on exercise progression.","[{'ForeName': 'Andrew Christopher', 'Initials': 'AC', 'LastName': 'Nixon', 'Affiliation': 'Department of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK andrew.nixon3@nhs.net.'}, {'ForeName': 'Theodoros M', 'Initials': 'TM', 'LastName': 'Bampouras', 'Affiliation': 'Lancaster Medical School, Lancaster University, Lancaster, Lancashire, UK.'}, {'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Gooch', 'Affiliation': 'Centre for Health Research and Innovation, NIHR Lancashire Clinical Research Facility, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK.'}, {'ForeName': 'Hannah M L', 'Initials': 'HML', 'LastName': 'Young', 'Affiliation': 'Department of Respiratory Sciences, University of Leicester, Leicester, UK.'}, {'ForeName': 'Kenneth William', 'Initials': 'KW', 'LastName': 'Finlayson', 'Affiliation': 'Research in Childbirth and Health Unit, University of Central Lancashire, Preston, Lancashire, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Pendleton', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Sandip', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'Manchester Academic Health Sciences Centre, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Brady', 'Affiliation': 'Department of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK.'}, {'ForeName': 'Ajay P', 'Initials': 'AP', 'LastName': 'Dhaygude', 'Affiliation': 'Department of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, Lancashire, UK.'}]",BMJ open,['10.1136/bmjopen-2019-035344']
1247,32533622,Blood pressure after follow-up in a stroke prevention clinic.,"OBJECTIVES


In Denmark, 25% of hospital admissions with stroke are recurrent strokes. With thrombolytic treatment, more patients survive with only minor disability. This promising development should be followed up by intensive secondary prevention. Hypertension is the most important target. We aimed at testing the hypotheses that early follow-up in a preventive clinic would result in (a) a higher proportion of patients with blood pressure at target and (b) time to stroke recurrence, myocardial infarction, and death would be longer in the intervention group compared to controls.
MATERIALS AND METHODS


Eligible patients admitted to the stroke unit of Herlev Hospital were randomized shortly before discharge to intervention or control group. Of 78 included participants, data from 73 were available for follow-up 9 months after inclusion. Patients in the intervention group were seen in the clinic within 1 week. In case of hypertension, treatment was initiated or supplied with a new drug. We used individual targets for blood pressure according to diagnosis of stroke and patients' comorbidity. Patients in the intervention group had a median of five visits to the preventive clinic.
RESULTS


In the intervention group, blood pressure was treated to target in 25 patients (69%) versus 14 (38%) in the control group (p = .007). Median time to first event was 44 months (4-49) in the intervention group and 19 months (4-37) in controls (p = .316).
CONCLUSIONS


Treatment of hypertension to individual targets after stroke is feasible. It may postpone recurrent stroke and death in stroke survivors.",2020,"In the intervention group, blood pressure was treated to target in 25 patients (69%) versus 14 (38%) in the control group (p = .007).","['Of 78 included participants, data from 73 were available for follow-up 9\xa0months after inclusion', 'In Denmark, 25% of hospital admissions with stroke are recurrent strokes', 'Eligible patients admitted to the stroke unit of Herlev Hospital']",[],"['blood pressure', 'median of five visits to the preventive clinic', 'Median time to first event', 'blood pressure at target and (b) time to stroke recurrence, myocardial infarction, and death', 'Blood pressure']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",78.0,0.0464616,"In the intervention group, blood pressure was treated to target in 25 patients (69%) versus 14 (38%) in the control group (p = .007).","[{'ForeName': 'Agnete Hviid', 'Initials': 'AH', 'LastName': 'Hornnes', 'Affiliation': 'Department of Neurology, Herlev og Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Mai Bang', 'Initials': 'MB', 'LastName': 'Poulsen', 'Affiliation': 'Department of Neurology, Rigshospitalet, Copenhagen, Denmark.'}]",Brain and behavior,['10.1002/brb3.1667']
1248,32533644,Effects of oxiracetam combined with ginkgo biloba extract in the treatment of acute intracerebral hemorrhage: A clinical study.,"PURPOSE


The present clinical study was conducted to investigate the effect of oxiracetam combined with ginkgo biloba extract in treating patients with acute intracerebral hemorrhage.
METHODS


Ninety-eight patients with acute cerebral hemorrhage admitted to our hospital were divided into three groups. The differences of brain edema and cerebral hemorrhage were compared between the three groups after 1 and 2 weeks of treatment, and the recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9, cognitive function, activities of daily living, and adverse reactions were compared between the three groups after 2 weeks of treatment.
RESULTS


There was no significant difference among the three groups before treatment (p > .05). After treatment, the recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living were improved. Among them, the neurological function recovery, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living in the combined treatment group and the control group elicited greater results than those in the routine group. The results of the combined treatment group showed the most significant difference (p < .05). The concentration of IL-6 decreased from 135.98 ± 12.54 to 91.83 ± 7.69 pg/ml, AQP-4 from 227.55 μg/L ± 21.06 to 114.31 ± 9.22 μg/L, and MMP-9 from 172.39 ± 9.81 to 94.98 ± 5.01 ng/ml. In addition, the neurological function recovery, the levels of serum inflammatory factors, cognitive function, and activities of daily living in the combined treatment group were better than those in the control group (p < .05). The mean score of MRS in the combined treatment group decreased from 3.36 ± 0.98 at admission to 1.91 ± 0.38.
CONCLUSION


Oxiracetam combined with Ginkgo biloba extract in the treatment of acute cerebral hemorrhage has a significant improvement effect.",2020,"After treatment, the recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living were improved.","['acute intracerebral hemorrhage', 'patients with acute intracerebral hemorrhage', 'Ninety-eight patients with acute cerebral hemorrhage admitted to our hospital']","['Ginkgo biloba extract', 'oxiracetam combined with ginkgo biloba extract']","['neurological function recovery, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living', 'neurological function recovery, the levels of serum inflammatory factors, cognitive function, and activities of daily living', 'acute cerebral hemorrhage', 'brain edema and cerebral hemorrhage', 'recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living', 'concentration of IL-6', 'mean score of MRS', 'recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9, cognitive function, activities of daily living, and adverse reactions']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0772125', 'cui_str': 'Ginkgo biloba extract'}, {'cui': 'C0069772', 'cui_str': 'oxiracetam'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0027767', 'cui_str': 'Nervous system function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0006114', 'cui_str': 'Cerebral edema'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",98.0,0.0301242,"After treatment, the recovery of neurological function, serum inflammatory factors, AQP-4, MMP-9 levels, cognitive function, and activities of daily living were improved.","[{'ForeName': 'Xiu-Xiu', 'Initials': 'XX', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Shi-Hui', 'Initials': 'SH', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Su-Jing', 'Initials': 'SJ', 'LastName': 'Zhuang', 'Affiliation': 'Department of Neurology, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Shi-Feng', 'Initials': 'SF', 'LastName': 'Guo', 'Affiliation': 'Department of Neurology, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Shou-Liang', 'Initials': 'SL', 'LastName': 'Pang', 'Affiliation': 'Department of Neurology, Linyi Central Hospital, Linyi, China.'}]",Brain and behavior,['10.1002/brb3.1661']
1249,32534250,External trigeminal nerve stimulation for drug resistant epilepsy: A randomized controlled trial.,"BACKGROUND


External trigeminal nerve stimulation (ETNS) is an emergent, non-invasive neurostimulation therapy delivered bilaterally with adhesive skin electrodes. In previous studies, ETNS was associated to a decrease in seizure frequency in patients with focal drug-resistant epilepsy (DRE).
OBJECTIVE


To determine the long-term efficacy and tolerability of ETNS in patients with focal DRE. Moreover, to explore whether its efficacy depends on the epileptogenic zone (frontal or temporal), and its impact on mood, cognitive function, quality of life, and trigeminal nerve excitability.
METHODS


Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery, were randomized to ETNS or usual medical treatment. Participants were evaluated at 3, 6 and 12 months for efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability.
RESULTS


Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs. At 12 months, percentage of responders was 50% in ETNS group and 0% in control group. Seizure frequency in ETNS group decreased by -43.5% from baseline. Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively). Median stimulation intensity was 6.2 mA. ETNS improved quality of life, but not anxiety or depression. Long-term ETNS affected neither neuropsychological function, nor trigeminal nerve excitability. No relevant adverse events were observed.
CONCLUSIONS


ETNS is an effective and well-tolerated therapy for focal DRE. Patients with temporal epilepsy showed a better response than those with frontal epilepsy. Future studies with larger populations may define its role compared to other neurostimulation techniques.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that ETNS reduces seizure frequency in patients with focal DRE.",2020,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","['Patients with temporal epilepsy', 'Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs', 'patients with focal drug-resistant epilepsy (DRE', 'drug resistant epilepsy', 'Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery', 'patients with focal DRE']","['ETNS or usual medical treatment', 'External trigeminal nerve stimulation (ETNS', 'ETNS', 'External trigeminal nerve stimulation']","['quality of life', 'seizure frequency', 'neuropsychological function, nor trigeminal nerve excitability', 'efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability', 'Seizure frequency', 'Median stimulation intensity', 'adverse events', 'anxiety or depression', 'mood, cognitive function, quality of life, and trigeminal nerve excitability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",40.0,0.130105,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gil-López', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain. Electronic address: fran.gil.lopez@gmail.com.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Boget', 'Affiliation': 'Epilepsy Unit, Department of Neuropsychology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Manzanares', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Donaire', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Conde-Blanco', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Baillés', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Pintor', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Setoaín', 'Affiliation': 'Epilepsy Unit, Department of Nuclear Medicine, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Bargalló', 'Affiliation': 'Epilepsy Unit, Department of Neurorradiology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Casanova', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Valls', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Roldán', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Rumià', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Casanovas', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Domenech', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Carreño', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}]",Brain stimulation,['10.1016/j.brs.2020.06.005']
1250,32534252,"Two weeks of image-guided left dorsolateral prefrontal cortex repetitive transcranial magnetic stimulation improves smoking cessation: A double-blind, sham-controlled, randomized clinical trial.","BACKGROUND


Previous studies have found that repetitive transcranial magnetic stimulation (rTMS) to the left dorsal lateral prefrontal cortex (LDLPFC) transiently reduces smoking craving, decreases cigarette consumption, and increases abstinence rates.
OBJECTIVE


We investigated whether 10 daily MRI-guided rTMS sessions over two weeks to the LDLPFC paired with craving cues could reduce cigarette consumption and induce smoking cessation.
METHODS


We enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day) in a randomized, double-blind, sham-controlled trial. Participants received 10 daily sessions over 2 weeks of either active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues. The primary outcome was a reduction in biochemically confirmed cigarette consumption with a secondary outcome of abstinence on the target quit date. We also recorded cue-induced craving and withdrawal symptoms.
RESULTS


Compared to sham (n = 17), participants receiving active rTMS (n = 21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P < .005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P < .001). Active rTMS participants were also more likely to quit by their target quit rate (23.81%vs. 0%, OR 11.67, 90% CL, 0.96-141.32, x 2  = 4.66, P = .031). Furthermore, rTMS significantly reduced mean craving throughout the treatments and at follow-up (29.93[13.12] vs. 25.01[14.45], P < .001). Interestingly across the active treatment sample, more lateral coil location was associated with more success in quitting (-43.43[0.40] vs. -41.79[2.24], P < .013).
CONCLUSIONS


Daily MRI-guided rTMS to the LDLPFC for 10 days reduces cigarette consumption and cued craving for up to one month and also increases the likelihood of smoking cessation.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02401672.",2020,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).",['enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day'],"['rTMS', 'Image-guided Left Dorsolateral Prefrontal Cortex Repetitive Transcranial Magnetic Stimulation Improves Smoking Cessation', 'active rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'LDLPFC paired with craving cues', 'active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues']","['abstinence on the target quit date', 'likelihood of smoking cessation', 'lateral coil location', 'cigarette consumption and cued craving', 'mean craving', 'likely to quit by their target quit rate']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]",42.0,0.428626,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).","[{'ForeName': 'Xingbao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA. Electronic address: lixi@musc.edu.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Hartwell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Henderson', 'Affiliation': 'Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Bashar W', 'Initials': 'BW', 'LastName': 'Badran', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.007']
1251,32539786,Prevention of severe infectious complications after colorectal surgery using oral non-absorbable antimicrobial prophylaxis: results of a multicenter randomized placebo-controlled clinical trial.,"BACKGROUND


Surgical site infections (SSIs) are common complications after colorectal surgery. Oral non-absorbable antibiotic prophylaxis (OAP) can be administered preoperatively to reduce the risk of SSIs. Its efficacy without simultaneous mechanical cleaning is unknown.
METHODS


The Precaution trial was a double-blind, placebo-controlled randomized clinical trial conducted in six Dutch hospitals. Adult patients who underwent elective colorectal surgery were randomized to receive either a three-day course of preoperative OAP with tobramycin and colistin or placebo. The primary composite endpoint was the incidence of deep SSI or mortality within 30 days after surgery. Secondary endpoints included both infectious and non-infectious complications at 30 days and six months after surgery.
RESULTS


The study was prematurely ended due to the loss of clinical equipoise. At that time, 39 patients had been randomized to active OAP and 39 to placebo, which reflected 8.1% of the initially pursued sample size. Nine (11.5%) patients developed the primary outcome, of whom four had been randomized to OAP (4/39; 10.3%) and five to placebo (5/39; 12.8%). This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78). In the per-protocol analysis, the relative risk was 0.64 (95% CI 0.12-3.46).
CONCLUSIONS


Observational data emerging during the study provided new evidence for the effectiveness of OAP that changed both the clinical and medical ethical landscape for infection prevention in colorectal surgery. We therefore consider it unethical to continue randomizing patients to placebo. We recommend the implementation of OAP in clinical practice and continuing monitoring of infection rates and antibiotic susceptibilities.
TRIAL REGISTRATION


The PreCaution trial is registered in the Netherlands Trial Register under NL5932 (previously: NTR6113) as well as in the EudraCT register under 2015-005736-17.",2020,This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78).,"['Adult patients who underwent elective colorectal surgery', 'six Dutch hospitals', '39 patients had been randomized to active OAP and 39 to']","['OAP', 'colorectal surgery using oral non-absorbable antimicrobial prophylaxis', 'preoperative OAP with tobramycin and colistin or placebo', 'Oral non-absorbable antibiotic prophylaxis (OAP', 'placebo']","['infectious and non-infectious complications', 'incidence of deep SSI or mortality', 'relative risk']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}]",,0.768962,This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78).,"[{'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Mulder', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Kluytmans-van den Bergh', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Vlaminckx', 'Affiliation': 'Department of Medical Microbiology, St. Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Roos', 'Affiliation': 'Department of Surgery, Reinier de Graaf Gasthuis, Delft, The Netherlands.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'de Smet', 'Affiliation': 'Department of Intensive Care Medicine, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'de Vos Tot Nederveen Cappel', 'Affiliation': 'Department of Surgery, Admiraal de Ruyter Hospital, Goes, The Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Verheijen', 'Affiliation': 'Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brandt', 'Affiliation': 'Department of Surgery, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Smits', 'Affiliation': 'Department of Surgery, St. Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'van der Vorm', 'Affiliation': 'Department of Medical Microbiology, Reinier de Graaf Gasthuis, Delft, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Bathoorn', 'Affiliation': 'Department of Medical Microbiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Boudewijn', 'Initials': 'B', 'LastName': 'van Etten', 'Affiliation': 'Department of Surgery, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jacobien', 'Initials': 'J', 'LastName': 'Veenemans', 'Affiliation': 'Department of Medical Microbiology, Admiraal de Ruyter Hospital, Goes, the Netherlands.'}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Weersink', 'Affiliation': 'Department of Medical Microbiology, Meander Medical Center, Amersfoort, The Netherlands.'}, {'ForeName': 'Margreet', 'Initials': 'M', 'LastName': 'Vos', 'Affiliation': 'Department of Microbiology and Infectious Diseases, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': ""van 't Veer"", 'Affiliation': 'Department of Clinical Pharmacy, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Nikolakopoulos', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kluytmans', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. jankluytmans@gmail.com.'}]",Antimicrobial resistance and infection control,['10.1186/s13756-020-00745-2']
1252,32540624,Effects of night-time bicycling visibility aids on vehicle passing distance.,"Bicycling at night is dangerous, with vehicle passing distances being a key concern, given that the main cause of night-time bicycling fatalities is from motorists hitting bicyclists from behind. However, little is known about vehicle passing distances at night or how they are affected by bicyclist visibility. This study assessed the impact of different bicyclist visibility configurations on vehicle passing distances at night-time. Fourteen licenced drivers with normal vision (age 24.2 ± 3.7 years) drove an experimental vehicle with low-beam headlights around a 1-km section of a closed-road circuit at night. Each lap involved passing two bicyclists displaying one of four visibility configurations: Control (red rear-facing light and reflector), Handlebars (control plus two red rear-facing lights on each handlebar), Helmet (control plus one red rear-facing light on the helmet), and Leg Retro-reflectors (control plus retro-reflective strips positioned on the knees and ankles). Participants were instructed to pass each bicyclist at a distance of 1-metre at a speed no greater than 50 km/hr, consistent with Queensland's Minimum Passing Distance rule. Participants completed eight laps, two for each configuration, in a randomised sequence. Passing distance was measured using a vehicle-mounted ultra-sonic sensor (ToughSonic14; Senix). Following each lap, participants rated the difficulty level in judging the 1-metre passing distance, as well as their estimated passing distance. Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other. There was also a significant effect of visibility configuration on difficulty rating (p = 0.035), with the Control rated as the most difficult, followed by Helmet, Handlebars and Leg Retro-reflectors. Overall, additional visibility aids resulted in wider vehicle passing distances, likely due to enhanced visual cues for drivers. The findings suggest that bicyclists should incorporate additional visibility aids to encourage safer passing distances of vehicles at night-time.",2020,"Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other.",['Fourteen licenced drivers with normal vision (age 24.2\u202f±\u202f3.7 years) drove an experimental vehicle with low-beam headlights around a 1-km section of a closed-road circuit at night'],"['visibility configurations: Control (red rear-facing light and reflector), Handlebars (control plus two red rear-facing lights on each handlebar), Helmet (control plus one red rear-facing light on the helmet), and Leg Retro-reflectors (control plus retro-reflective strips positioned on the knees and ankles', 'night-time bicycling visibility aids']","['visibility configuration on difficulty rating', 'Leg Retro-reflectors']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0234622', 'cui_str': 'Normal vision'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]",,0.0635457,"Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other.","[{'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Black', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia. Electronic address: aa.black@qut.edu.au.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Duff', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Hutchinson', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ng', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Kirby', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Ussher', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Wood', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105636']
1253,32540887,"Effectiveness of breathing exercises, foot reflexology and back massage (BRM) on labour pain, anxiety, duration, satisfaction, stress hormones and newborn outcomes among primigravidae during the first stage of labour in Saudi Arabia: a study protocol for a randomised controlled trial.","INTRODUCTION


Labour pain is among the severest pains primigravidae may experience during pregnancy. Failure to address labour pain and anxiety may lead to abnormal labour. Despite the many complementary non-pharmacological approaches to coping with labour pain, the quality of evidence is low and best approaches are not established. This study protocol describes a proposed investigation of the effects of a combination of breathing exercises, foot reflexology and back massage (BRM) on the labour experiences of primigravidae.
METHODS AND ANALYSIS


This randomised controlled trial will involve an intervention group receiving BRM and standard labour care, and a control group receiving only standard labour care. Primigravidae of 26-34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal clinics. Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use. The BRM intervention will be delivered by a trained massage therapist. The primary outcomes of labour pain and anxiety will be measured during and after uterine contractions at baseline (cervical dilatation 6 cm) and post BRM hourly for 2 hours. The secondary outcomes include maternal stress hormone (adrenocorticotropic hormone, cortisol and oxytocin) levels, maternal vital signs (V/S), fetal heart rate, labour duration, Apgar scores and maternal satisfaction. The sample size is estimated based on the between-group difference of 0.6 in anxiety scores, 95% power and 5% α error, which yields a required sample size of 154 (77 in each group) accounting for a 20% attrition rate. The between-group and within-group outcome measures will be examined with mixed-effect regression models, time series analyses and paired t-test or equivalent non-parametric tests, respectively.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the Ethical Committee for Research Involving Human Subjects of the Ministry of Health in the Saudi Arabia (H-02-K-076-0319-109) on 14 April 2019, and from the Ethics Committee for Research Involving Human Subjects (JKEUPM) Universiti Putra Malaysia on 23 October 2019, reference number: JKEUPM-2019-169. Written informed consent will be obtained from all participants. Results from this trial will be presented at regional, national and international conferences and published in indexed journals.
TRIAL REGISTRATION NUMBER


ISRCTN87414969, registered 3 May 2019.",2020,Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use.,"['Eligible and consenting patients', 'primigravidae during the first stage of labour in Saudi Arabia', 'labour experiences of primigravidae', 'Human Subjects of the Ministry of Health in the Saudi Arabia (H-02-K-076-0319-109) on 14 April 2019, and from the Ethics Committee for Research Involving Human Subjects (JKEUPM', 'Primigravidae of 26-34 weeks of gestation without chronic diseases or pregnancy-related complications will be recruited from antenatal clinics']","['breathing exercises, foot reflexology and back massage (BRM', 'BRM and standard labour care, and a control group receiving only standard labour care', 'pethidine']","['labour pain and anxiety will be measured during and after uterine contractions at baseline (cervical dilatation 6\u2009cm) and post BRM hourly for 2\u2009hours', 'maternal stress hormone (adrenocorticotropic hormone, cortisol and oxytocin) levels, maternal vital signs (V/S), fetal heart rate, labour duration, Apgar scores and maternal satisfaction', 'mixed-effect regression models, time series analyses and paired t-test or equivalent non-parametric tests, respectively', 'labour pain, anxiety, duration, satisfaction, stress hormones and newborn outcomes']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022871', 'cui_str': 'First stage of labor'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0085546', 'cui_str': 'Ethics Committees'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}]","[{'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1171200', 'cui_str': 'Labor care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}]","[{'cui': 'C0474368', 'cui_str': 'Labor pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042130', 'cui_str': 'Uterine contraction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.157332,Eligible and consenting patients will be randomly allocated to the intervention or the control group stratified by intramuscular pethidine use.,"[{'ForeName': 'Kamilya Jamel', 'Initials': 'KJ', 'LastName': 'Baljon', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Muhammad Hibatullah', 'Initials': 'MH', 'LastName': 'Romli', 'Affiliation': 'Department of Nursing & Rehabilitation, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Adibah Hanim', 'Initials': 'AH', 'LastName': 'Ismail', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Khuan', 'Affiliation': 'Department of Nursing & Rehabilitation, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia.'}, {'ForeName': 'Boon How', 'Initials': 'BH', 'LastName': 'Chew', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Serdang, Malaysia chewboonhow@upm.edu.my.'}]",BMJ open,['10.1136/bmjopen-2019-033844']
1254,32540986,Improving HPV Vaccination Rates: A Stepped-Wedge Randomized Trial.,"OBJECTIVES


To evaluate the effectiveness of a stepped-wedge randomized trial of Development of Systems and Education for Human Papillomavirus Vaccination (DOSE HPV), a multilevel intervention.
METHODS


DOSE HPV is a 7-session program that includes interprofessional provider education, communication training, data feedback, and tailored systems change. Five primary care pediatric and/or family medicine practices completed interventions between 2016 and 2018; all chose to initiate vaccination at ages 9 to 10. We compared vaccination rates in the preintervention, intervention, and postintervention periods among 9- to 17-year-olds using random-effects generalized linear regression models appropriate for stepped-wedge design, accounting for calendar time and clustering of patients by providers and clinic. Outcomes included (1) the likelihood that eligible patients would receive vaccination during clinic visits; (2) the likelihood that adolescents would complete the series by age 13; and (3) the cumulative effect on population-level vaccine initiation and completion rates. Postintervention periods ranged from 6 to 18 months.
RESULTS


In the intervention and postintervention periods, the adjusted likelihood of vaccination at an eligible visit increased by >10 percentage points for ages 9 to 10 and 11 to 12, and completion of the vaccine series by age 13 increased by 4 percentage points ( P  < .001 for all comparisons). Population-level vaccine initiation coverage increased from 75% (preintervention) to 84% (intervention) to 90% (postintervention), and completion increased from 60% (preintervention) to 63% (intervention) to 69% (postintervention).
CONCLUSIONS


Multilevel interventions that include provider education, data feedback, tailored systems changes, and early initiation of the human papillomavirus vaccine series may improve vaccine series initiation and completion beyond the conclusion of the intervention period.",2020,"Population-level vaccine initiation coverage increased from 75% (preintervention) to 84% (intervention) to 90% (postintervention), and completion increased from 60% (preintervention) to 63% (intervention) to 69% (postintervention).
",['Five primary care pediatric and/or family medicine practices completed interventions between 2016 and 2018; all chose to initiate vaccination at ages 9 to 10'],['Systems and Education for Human Papillomavirus Vaccination (DOSE HPV'],"['vaccination rates', 'HPV Vaccination Rates', 'Population-level vaccine initiation coverage', 'cumulative effect on population-level vaccine initiation and completion rates']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.0663215,"Population-level vaccine initiation coverage increased from 75% (preintervention) to 84% (intervention) to 90% (postintervention), and completion increased from 60% (preintervention) to 63% (intervention) to 69% (postintervention).
","[{'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Perkins', 'Affiliation': 'Departments of Obstetrics and Gynecology and rbperkin@bu.edu.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Legler', 'Affiliation': 'Pediatrics and Adolescent Medicine, School of Medicine, Boston University and Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Jansen', 'Affiliation': 'Continuing Medical Education Office.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bernstein', 'Affiliation': 'Department of Health Law, Policy and Management, School of Public Health.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Pierre-Joseph', 'Affiliation': 'Pediatrics and Adolescent Medicine, School of Medicine, Boston University and Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Terresa J', 'Initials': 'TJ', 'LastName': 'Eun', 'Affiliation': 'Department of Sociology, Stanford University, Stanford, California.'}, {'ForeName': 'Dea L', 'Initials': 'DL', 'LastName': 'Biancarelli', 'Affiliation': 'Department of Health Law, Policy and Management, School of Public Health.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Schuch', 'Affiliation': 'South Boston Community Health Center, Boston, Massachusetts.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Leschly', 'Affiliation': 'East Boston Neighborhood Health Center, Boston, Massachusetts; and.'}, {'ForeName': 'Anny T H R', 'Initials': 'ATHR', 'LastName': 'Fenton', 'Affiliation': 'Center for Outcomes, Research, and Evaluation, Maine Medical Center Research Institute, Portland, Maine.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Adams', 'Affiliation': 'Pediatrics and Adolescent Medicine, School of Medicine, Boston University and Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Clark', 'Affiliation': 'Department of Health Law, Policy and Management, School of Public Health.'}, {'ForeName': 'Mari-Lynn', 'Initials': 'ML', 'LastName': 'Drainoni', 'Affiliation': 'Department of Health Law, Policy and Management, School of Public Health.'}, {'ForeName': 'Amresh', 'Initials': 'A', 'LastName': 'Hanchate', 'Affiliation': 'General Internal Medicine, Department of Medicine, and.'}]",Pediatrics,['10.1542/peds.2019-2737']
1255,32534646,"Atezolizumab, vemurafenib, and cobimetinib as first-line treatment for unresectable advanced BRAF V600  mutation-positive melanoma (IMspire150): primary analysis of the randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND


IMspire150 aimed to evaluate first-line combination treatment with BRAF plus MEK inhibitors and immune checkpoint therapy in BRAF V600  mutation-positive advanced or metastatic melanoma.
METHODS


IMspire150 was a randomised, double-blind, placebo-controlled phase 3 study done at 112 institutes in 20 countries. Patients with unresectable stage IIIc-IV, BRAF V600  mutation-positive melanoma were randomly assigned 1:1 to 28-day cycles of atezolizumab, vemurafenib, and cobimetinib (atezolizumab group) or atezolizumab placebo, vemurafenib, and cobimetinib (control group). In cycle 1, all patients received vemurafenib and cobimetinib only; atezolizumab placebo was added from cycle 2 onward. Randomisation was stratified by lactate dehydrogenase concentration and geographical region. Blinding for atezolizumab was achieved by means of an identical intravenous placebo, and blinding for vemurafenib was achieved by means of a placebo tablet. The primary outcome was investigator-assessed progression-free survival. This trial (ClinicalTrials.gov, NCT02908672) is ongoing but no longer recruiting patients.
FINDINGS


Between Jan 13, 2017, and April 26, 2018, 777 patients were screened and 514 were enrolled and randomly assigned to the atezolizumab group (n=256) or control group (n=258). At a median follow-up of 18·9 months (IQR 10·4-23·8), progression-free survival as assessed by the study investigator was significantly prolonged with atezolizumab versus control (15·1 vs 10·6 months; hazard ratio [HR] 0·78; 95% CI 0·63-0·97; p=0·025). Common treatment-related adverse events (>30%) in the atezolizumab and control groups were blood creatinine phosphokinase increased (51·3% vs 44·8%), diarrhoea (42·2% vs 46·6%), rash (40·9%, both groups), arthralgia (39·1% vs 28·1%), pyrexia (38·7% vs 26·0%), alanine aminotransferase increased (33·9% vs 22·8%), and lipase increased (32·2% vs 27·4%); 13% of patients in the atezolizumab group and 16% in the control group stopped all treatment because of adverse events.
INTERPRETATION


The addition of atezolizumab to targeted therapy with vemurafenib and cobimetinib was safe and tolerable and significantly increased progression-free survival in patients with BRAF V600  mutation-positive advanced melanoma.
FUNDING


F Hoffmann-La Roche and Genentech.",2020,"Common treatment-related adverse events (>30%) in the atezolizumab and control groups were blood creatinine phosphokinase increased (51·3% vs 44·8%), diarrhoea (42·2% vs 46·6%), rash (40·9%, both groups), arthralgia (39·1% vs 28·1%), pyrexia (38·7% vs 26·0%), alanine aminotransferase increased (33·9% vs 22·8%), and lipase increased (32·2% vs 27·4%); 13% of patients in the atezolizumab group and 16% in the control group stopped all treatment because of adverse events.
","['Between Jan 13, 2017, and April 26, 2018, 777 patients were screened and 514 were enrolled and randomly assigned to the', 'Patients with unresectable stage IIIc-IV, BRAF V600  mutation-positive melanoma', 'patients with BRAF V600  mutation-positive advanced melanoma', 'controlled phase 3 study done at 112 institutes in 20 countries', 'BRAF V600  mutation-positive advanced or metastatic melanoma', 'group (n=256) or control group (n=258']","['BRAF plus MEK inhibitors', 'Atezolizumab, vemurafenib, and cobimetinib', 'atezolizumab, vemurafenib, and cobimetinib (atezolizumab group) or atezolizumab placebo, vemurafenib, and cobimetinib (control group', 'atezolizumab', 'vemurafenib and cobimetinib only; atezolizumab placebo', 'vemurafenib and cobimetinib', 'placebo']","['progression-free survival', 'diarrhoea', 'pyrexia', 'alanine aminotransferase', 'investigator-assessed progression-free survival', 'blood creatinine phosphokinase', 'adverse events', 'rash', 'arthralgia', 'lipase']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0383375', 'cui_str': 'AT 112'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2347168', 'cui_str': 'Mitogen-activated protein kinase kinase inhibitor'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C3192263', 'cui_str': 'Vemurafenib'}, {'cui': 'C4049146', 'cui_str': 'Cobimetinib'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0201975', 'cui_str': 'Creatinine measurement'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}]",777.0,0.732647,"Common treatment-related adverse events (>30%) in the atezolizumab and control groups were blood creatinine phosphokinase increased (51·3% vs 44·8%), diarrhoea (42·2% vs 46·6%), rash (40·9%, both groups), arthralgia (39·1% vs 28·1%), pyrexia (38·7% vs 26·0%), alanine aminotransferase increased (33·9% vs 22·8%), and lipase increased (32·2% vs 27·4%); 13% of patients in the atezolizumab group and 16% in the control group stopped all treatment because of adverse events.
","[{'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Haut-Tumor-Zentrum Hannover, Klinik für Dermatologie, Allergologie und Venerologie, Medizinische Hochschule Hannover, Hannover, Germany. Electronic address: gutzmer.ralf@mh-hannover.de.'}, {'ForeName': 'Daniil', 'Initials': 'D', 'LastName': 'Stroyakovskiy', 'Affiliation': 'Moscow City Oncology Hospital Number 62 of Moscow Healthcare Department, Moscow, Russia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Gogas', 'Affiliation': 'First Department of Medicine, Laiko General Hospital, National and Kapodistrian University of Athens, Greece.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy and Université Paris-Saclay, Villejuif-Paris, France.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Lewis', 'Affiliation': 'University of Colorado Comprehensive Cancer Center, Aurora, CO, USA.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Protsenko', 'Affiliation': 'Department of Chemotherapy and Innovative Technologies, NN Petrov National Medical Research Center of Oncology, St Petersburg, Russia.'}, {'ForeName': 'Rodrigo P', 'Initials': 'RP', 'LastName': 'Pereira', 'Affiliation': 'Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eigentler', 'Affiliation': 'University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Rutkowski', 'Affiliation': 'Department of Soft Tissue-Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Lev', 'Initials': 'L', 'LastName': 'Demidov', 'Affiliation': 'NN Blokhin Russian Cancer Research Center, Ministry of Health, Moscow, Russia.'}, {'ForeName': 'Georgy Moiseevich', 'Initials': 'GM', 'LastName': 'Manikhas', 'Affiliation': 'St Petersburg Oncology Hospital, St Petersburg, Russia.'}, {'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Kuan-Chieh', 'Initials': 'KC', 'LastName': 'Huang', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Uyei', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'McNally', 'Affiliation': 'Roche Products, Welwyn Garden City, UK.'}, {'ForeName': 'Grant A', 'Initials': 'GA', 'LastName': 'McArthur', 'Affiliation': 'Melanoma and Skin Service and Cancer Therapeutics Program, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': 'Istituto Nazionale Tumori IRCCS Fondazione G Pascale, Naples, Italy.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30934-X']
1256,32534647,"Cancer prevention with aspirin in hereditary colorectal cancer (Lynch syndrome), 10-year follow-up and registry-based 20-year data in the CAPP2 study: a double-blind, randomised, placebo-controlled trial.","BACKGROUND


Lynch syndrome is associated with an increased risk of colorectal cancer and with a broader spectrum of cancers, especially endometrial cancer. In 2011, our group reported long-term cancer outcomes (mean follow-up 55·7 months [SD 31·4]) for participants with Lynch syndrome enrolled into a randomised trial of daily aspirin versus placebo. This report completes the planned 10-year follow-up to allow a longer-term assessment of the effect of taking regular aspirin in this high-risk population.
METHODS


In the double-blind, randomised CAPP2 trial, 861 patients from 43 international centres worldwide (707 [82%] from Europe, 112 [13%] from Australasia, 38 [4%] from Africa, and four [<1%] from The Americas) with Lynch syndrome were randomly assigned to receive 600 mg aspirin daily or placebo. Cancer outcomes were monitored for at least 10 years from recruitment with English, Finnish, and Welsh participants being monitored for up to 20 years. The primary endpoint was development of colorectal cancer. Analysis was by intention to treat and per protocol. The trial is registered with the ISRCTN registry, number ISRCTN59521990.
FINDINGS


Between January, 1999, and March, 2005, 937 eligible patients with Lynch syndrome, mean age 45 years, commenced treatment, of whom 861 agreed to be randomly assigned to the aspirin group or placebo; 427 (50%) participants received aspirin and 434 (50%) placebo. Participants were followed for a mean of 10 years approximating 8500 person-years. 40 (9%) of 427 participants who received aspirin developed colorectal cancer compared with 58 (13%) of 434 who received placebo. Intention-to-treat Cox proportional hazards analysis revealed a significantly reduced hazard ratio (HR) of 0·65 (95% CI 0·43-0·97; p=0·035) for aspirin versus placebo. Negative binomial regression to account for multiple primary events gave an incidence rate ratio of 0·58 (0·39-0·87; p=0·0085). Per-protocol analyses restricted to 509 who achieved 2 years' intervention gave an HR of 0·56 (0·34-0·91; p=0·019) and an incidence rate ratio of 0·50 (0·31-0·82; p=0·0057). Non-colorectal Lynch syndrome cancers were reported in 36 participants who received aspirin and 36 participants who received placebo. Intention-to-treat and per-protocol analyses showed no effect. For all Lynch syndrome cancers combined, the intention-to-treat analysis did not reach significance but per-protocol analysis showed significantly reduced overall risk for the aspirin group (HR=0·63, 0·43-0·92; p=0·018). Adverse events during the intervention phase between aspirin and placebo groups were similar, and no significant difference in compliance between intervention groups was observed for participants with complete intervention phase data; details reported previously.
INTERPRETATION


The case for prevention of colorectal cancer with aspirin in Lynch syndrome is supported by our results.
FUNDING


Cancer Research UK, European Union, MRC, NIHR, Bayer Pharma AG, Barbour Foundation.",2020,"Adverse events during the intervention phase between aspirin and placebo groups were similar, and no significant difference in compliance between intervention groups was observed for participants with complete intervention phase data; details reported previously.
","['861 patients from 43 international centres worldwide (707 [82%] from Europe, 112 [13%] from Australasia, 38 [4%] from Africa, and four [<1%] from The Americas) with Lynch syndrome', 'hereditary colorectal cancer (Lynch syndrome', 'Participants were followed for a mean of 10 years approximating 8500 person-years', '937 eligible patients with Lynch syndrome, mean age 45 years, commenced treatment, of whom 861 agreed to be randomly assigned to the', '427 participants who received', 'and 36 participants who received']","['aspirin group or placebo', 'aspirin versus placebo', 'aspirin', 'aspirin daily or placebo', 'placebo']","['development of colorectal cancer', 'Adverse events', 'long-term cancer outcomes', 'hazard ratio (HR) of 0·65', 'overall risk', 'colorectal cancer', 'compliance', 'Cancer outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0282279', 'cui_str': 'Australasia'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C1333990', 'cui_str': 'HNPCC - hereditary nonpolyposis colon cancer'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4517893', 'cui_str': '8500'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",861.0,0.749563,"Adverse events during the intervention phase between aspirin and placebo groups were similar, and no significant difference in compliance between intervention groups was observed for participants with complete intervention phase data; details reported previously.
","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Burn', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK. Electronic address: john.burn@newcastle.ac.uk.'}, {'ForeName': 'Harsh', 'Initials': 'H', 'LastName': 'Sheth', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Faye', 'Initials': 'F', 'LastName': 'Elliott', 'Affiliation': ""Division of Haematology and Immunology, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Reed', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Finlay', 'Initials': 'F', 'LastName': 'Macrae', 'Affiliation': 'Colorectal Medicine and Genetics, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Jukka-Pekka', 'Initials': 'JP', 'LastName': 'Mecklin', 'Affiliation': 'Department of Education & Research, Jyväskylä Central Hospital, Jyväskylä, Finland; Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Möslein', 'Affiliation': 'St Josefs-Hospital, Bochum-Linden, Germany.'}, {'ForeName': 'Fiona E', 'Initials': 'FE', 'LastName': 'McRonald', 'Affiliation': 'National Cancer Registration and Analysis Service, Public Health England, London, UK.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Bertario', 'Affiliation': 'Instituto Nazionale per lo Studio e, la Cura dei Tumori, Milan, Italy.'}, {'ForeName': 'D Gareth', 'Initials': 'DG', 'LastName': 'Evans', 'Affiliation': ""Division of Evolution and Genomic Medicine, University of Manchester, Manchester, UK; St Mary's Hospital, Manchester Universities Foundation Trust, Manchester, UK.""}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Gerdes', 'Affiliation': 'Clinical Genetics, Rigshospital, Copenhagen, Denmark.'}, {'ForeName': 'Judy W C', 'Initials': 'JWC', 'LastName': 'Ho', 'Affiliation': 'Hereditary GI Cancer Registry, Department of Surgery, Queen Mary Hospital, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Lindblom', 'Affiliation': 'Department of Molecular Medicine & Surgery, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Morrison', 'Affiliation': 'Department of Medical Genetics, Queens University Belfast, Belfast City Hospital HSC Trust, Belfast, UK.'}, {'ForeName': 'Jem', 'Initials': 'J', 'LastName': 'Rashbass', 'Affiliation': 'National Cancer Registration and Analysis Service, Public Health England, London, UK.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Ramesar', 'Affiliation': 'Genomic and Precision Medicine Research Unit, Division of Human Genetics, Institute of Infectious Diseases and Molecular Medicine, Faculty of Health Sciences, University of Cape Town, South Africa.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Seppälä', 'Affiliation': 'Department of Gastrointestinal Surgery, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Huw J W', 'Initials': 'HJW', 'LastName': 'Thomas', 'Affiliation': ""St Mark's Hospital, London, UK; Faculty of Medicine, Imperial College London, London, UK.""}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Pylvänäinen', 'Affiliation': 'Department of Education & Research, Jyväskylä Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Gillian M', 'Initials': 'GM', 'LastName': 'Borthwick', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Mathers', 'Affiliation': 'Human Nutrition Research Centre, Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'D Timothy', 'Initials': 'DT', 'LastName': 'Bishop', 'Affiliation': ""Division of Haematology and Immunology, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30366-4']
1257,32543162,Effects of alternate nostril breathing exercise on cardiac functions in healthy young adults leading a stressful lifestyle.,"Alternate nostril breathing (ANB) is one of the best and easiest breathing exercises. ANB exercise has beneficial effects on cardiac function in healthy and diseased people. The objectives of this study were to assess the effects of ANB exercise on cardiac physiology among healthy medical students. This was a prospective interventional study that was conducted in the Department of Physiology, Chittagong Medical College (CMC), Chattogram, Bangladesh, from July 2017 to June 2018. A total of 100 research participants (RPs) aged 18-20 years, Year-I medical students of CMC, were selected. A simple random sampling method was adopted. The selection was done after the inclusion and exclusion criteria were applied. The age and body mass index (BMI) of the RPs were analogous in both the control and experimental groups. Cardiac parameters, like pulse and blood pressure (BP), were measured. The initial baseline data were recorded for both groups and after 4 weeks. The research respondents of the experimental group performed ANB exercise for 4 weeks. The mean value pulse and BP were significantly (p < 0.001) changed after breathing exercise, compared to the values before the breathing exercise. The results of this study suggest that cardiac function significantly improves after the breathing exercise. Therefore, ANB can be recommended for increasing cardiac efficiency.",2020,"The mean value pulse and BP were significantly (p < 0.001) changed after breathing exercise, compared to the values before the breathing exercise.","['healthy young adults leading a stressful lifestyle', '100 research participants (RPs) aged 18-20 years, Year-I medical students of CMC, were selected', 'healthy and diseased people', 'Department of Physiology, Chittagong Medical College (CMC), Chattogram, Bangladesh, from July 2017 to June 2018', 'healthy medical students']","['ANB exercise', 'alternate nostril breathing exercise', 'Alternate nostril breathing (ANB']","['cardiac functions', 'cardiac function', 'Cardiac parameters, like pulse and blood pressure (BP', 'mean value pulse and BP']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0595944', 'cui_str': 'Both anterior nares'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",100.0,0.0262245,"The mean value pulse and BP were significantly (p < 0.001) changed after breathing exercise, compared to the values before the breathing exercise.","[{'ForeName': 'Iffat', 'Initials': 'I', 'LastName': 'Jahan', 'Affiliation': 'Department of Physiology, Eastern Medical College, Cumilla, Bangladesh; runurono@gmail.com.'}, {'ForeName': 'Momtaz', 'Initials': 'M', 'LastName': 'Begum', 'Affiliation': 'Department of Physiology, Chittagong Medical College, Chattogram, Bangladesh.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhter', 'Affiliation': 'Department of Physiology, Chittagong Medical College, Chattogram, Bangladesh.'}, {'ForeName': 'Zakirul', 'Initials': 'Z', 'LastName': 'Islam', 'Affiliation': 'Department of Pharmacology, Eastern Medical College, Cumilla, Bangladesh.'}, {'ForeName': 'Mainul', 'Initials': 'M', 'LastName': 'Haque', 'Affiliation': 'Universiti Pertahanan Nasional Malaysia (National Defence University of Malaysia), Kuala Lumpur, Malaysia.'}, {'ForeName': 'Nusrat', 'Initials': 'N', 'LastName': 'Jahan', 'Affiliation': 'Department of Internal Medicine, United Hospital, Dhaka, Bangladesh.'}]",Journal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique,['10.15586/jptcp.v27i2.675']
1258,32535263,Effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery: A randomized controlled trial.,"BACKGROUND


Postoperative cognitive dysfunction (POCD) is a complication of central nervous system in patients after surgery. Edaravone as a brain-protective agent may have protective effect on postoperative cognitive function. The study was designed to explore the effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery and potential mechanism.
PATIENTS AND METHODS


Patients undergoing hip joint replacement surgery were randomly allocated into 2 groups: the edaravone group (group E) and the control group (group C). Group E received intravenous edaravone at a dose of 0.5 mg/kg after induction of anesthesia, while group C received normal saline. The cognitive function was evaluated with the Mini-Mental State Examination (MMSE) 1day before surgery,3 days and the 7 days after surgery. Patients' plasma samples were collected to detect the levels of S100β protein (S100β), interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), superoxide dismutase (SOD) and malondialdehyde (MDA) before the induction of anesthesia, at the end of surgery and on postoperative day 3.
RESULTS


The MMSE scores in group E were higher than those of group C 3 days after surgery (25.98 ± 1.99 vs 24.86 ± 1.86, p = 0.003). There were remarkable rises (p < 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p < 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03 ± 2.46U/ml vs. 13.65 ± 2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01 ± 2.37 nmol/ml vs. 11.34 ± 3.18 nmol/ml, p = 0.0001).
CONCLUSION


The results indicated that preoperative intervention with edaravone may improve the postoperative cognitive function in elderly patients undergoing hip joint replacement surgery.",2020,"There were remarkable rises (p< 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p< 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03±2.46U/ml vs. 13.65±2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01±2.37nmol/ml vs. 11.34±3.18nmol/ml, p = 0.0001).
","['eldely patients undergoing hip joint replacement surgery and potential mechanism', 'Patients undergoing hip joint replacement surgery', 'patients after surgery', 'elderly patients undergoing hip joint replacement surgery']","['intravenous edaravone', 'normal saline', 'edaravone', 'Edaravone']","['MDA level', 'MMSE scores', 'cognitive function', 'SOD concentration', 'levels of S100β protein (S100β), interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), superoxide dismutase (SOD) and malondialdehyde (MDA', 'postoperative cognitive function', 'plasma IL-6, S100βand MMP-9 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.097904,"There were remarkable rises (p< 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p< 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03±2.46U/ml vs. 13.65±2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01±2.37nmol/ml vs. 11.34±3.18nmol/ml, p = 0.0001).
","[{'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Chinese Traditional Medicine, 528 Zhangheng Road, Pudong, Shanghai, 201203, China. Electronic address: sun_long2@163.com.'}, {'ForeName': 'Wen-Ting', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Chinese Traditional Medicine, 528 Zhangheng Road, Pudong, Shanghai, 201203, China.'}, {'ForeName': 'Yang-Liang', 'Initials': 'YL', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China. Electronic address: nange1984@sina.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.092']
1259,32535341,Effects and safety of body positioning on back pain after transcatheter arterial chemoembolization in people with hepatocellular carcinoma: A randomized controlled study.,"BACKGROUND


People with hepatocellular carcinoma who undergo transcatheter arterial chemoembolization usually experience back pain due to lie supine for at least 4 hours to avoid bleeding and hematoma. Body positioning is an effective and safe method for decreasing back pain in people with transfemoral cardiac catheterization; however, its effects and safety among patients with high bleeding tendency are unknown.
OBJECTIVE


To investigate whether body positioning could decrease back pain without increasing the chance of bleeding after transcatheter arterial chemoembolization.
DESIGN


A single-blind randomized controlled trial (ClinicalTrials.gov No.: NCT03784469).
METHODS


A total of 78 people with liver cancer who had undergone chemoembolization through the femoral artery were enrolled. Each person was randomly assigned to either the control or intervention group (each consisted of 39 participants). The control group received the usual care, remaining flat and lying in a supine position, whereas the intervention group had their positions changed in the second and fourth hour after chemoembolization. Participants' pain level was rated by using numerical rating scale -11 (score from 0 to 10), bleeding was measured by using volume of blood (cc.) in gauze and hematoma size in diameter (cm), and satisfaction was self-rated from 1 to 5. Repeated-measure analysis of variance (ANOVA) was used to compare the difference in pain levels over time within each group and independent t test to compare the mean difference of pain between groups at 5 endpoints, both methods with Bonferroni adjustment. Independent t test, chi-squared test, and Fisher's exact test compared postembolization discomfort, puncture sites bleeding, satisfaction between groups.
RESULTS


Significant changes of pain levels over time in both intervention [F(2.93, 111.20)=7.64, p<.001] and control groups [F(2.66, 101.17)=20.55, p<.001]. The intervention group had a significantly lower mean pain score in the second hour (t = -2.838, p = .006) and fourth hour (t = -4.739, p < .001) when patients turning to the side than did the control group lying supine. Furthermore, patients in the intervention group had significantly higher satisfaction than did those in the control group (t = -2.422, p = .018). No hematoma and significant difference of post-procedural bleeding between groups.
CONCLUSION


Changing patients' body positions in bed after transcatheter arterial chemoembolization is a safe and effective method of decreasing back pain, and increasing patients' satisfaction, without increasing the complications of bleeding and hematoma. Clinicians should change the positions of people with hepatocellular carcinoma 2 hours after they receive transcatheter arterial chemoembolization.",2020,"-4.739, p < .001) when patients turning to the side than did the control group lying supine.","['people with hepatocellular carcinoma', '78 people with liver cancer who had undergone chemoembolization through the femoral artery were enrolled', 'People with hepatocellular carcinoma who undergo transcatheter arterial chemoembolization usually experience back pain', 'people with transfemoral cardiac catheterization']","['body positioning', 'transcatheter arterial chemoembolization']","['pain level', 'pain levels', 'back pain', 'numerical rating scale -11', 'bleeding', 'mean pain score', 'higher satisfaction']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}]","[{'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",78.0,0.143191,"-4.739, p < .001) when patients turning to the side than did the control group lying supine.","[{'ForeName': 'Kai-Ting', 'Initials': 'KT', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, No.7, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: kaiting105866@gmail.com.'}, {'ForeName': 'Chun-Jen', 'Initials': 'CJ', 'LastName': 'Liu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National, Taiwan University Hospital, No.7, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: cjliu@ntu.edu.tw.'}, {'ForeName': 'Hsiu-Ting', 'Initials': 'HT', 'LastName': 'Tsai', 'Affiliation': 'Post-Baccalaureate Program in Nursing, Taipei Medical University, No. 250 Wu-Xing Street, Taipei City, 110, Taiwan. Electronic address: hsiuting@tmu.edu.tw.'}, {'ForeName': 'Tse-Pin', 'Initials': 'TP', 'LastName': 'Hsu', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: 021077@ntuh.gov.tw.'}, {'ForeName': 'Po-Ting', 'Initials': 'PT', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Imaging, National Taiwan University Hospital, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: nate770407@gmail.com.'}, {'ForeName': 'Sophia H', 'Initials': 'SH', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, College of Nursing, National Yang-Ming University, No.155, Sec.2, Li-Nong Street, Taipei City, 112, Taiwan. Electronic address: sophiahu@ym.edu.tw.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103641']
1260,32574722,HSD3B1 (1245A>C) germline variant and clinical outcomes in metastatic castration-resistant prostate cancer patients treated with abiraterone and enzalutamide: results from two prospective studies.,"BACKGROUND


A common polymorphism (1245A>C) in the HSD3B1 gene is associated with increased de novo synthesis of androgens and worse outcomes in men treated with androgen-deprivation therapy for metastatic castration-sensitive prostate cancer. The objective of the study was to determine whether this polymorphism is associated with outcomes for metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone or enzalutamide.
PATIENTS AND METHODS


A total of 547 patients treated with abiraterone or enzalutamide from two prospective cohorts were evaluated. The HSD3B1 genotype was determined by targeted sequencing and/or TaqMan single-nucleotide polymorphism genotyping. In cohort 1, patients were randomized to receive abiraterone + prednisone or enzalutamide. In cohort 2, patients received either agent according to investigator's choice. Prostate-specific antigen (PSA) response rate, time to PSA progression (TTPP), time to progression (TTP) and overall survival were determined. Associations between HSD3B1 genotypes and outcomes were evaluated via univariate Cox regression. Multivariable Cox model was used to determine the independent association of each covariate.
RESULTS


The HSD3B1 variant genotype (CC) was present in 15% of patients and was associated with worse TTP [hazard ratio (HR) 1.31, 95% confidence interval (CI) 1.02-1.67, P = 0.032] and PSA response rates (48% for CC versus 62% and 65% for AA and AC, respectively [P = 0.019]), with no significant difference in TTPP (HR 1.28, 95% CI 0.99-1.66, P = 0.064). The effect of genotype was similar for treatment with abiraterone or enzalutamide with a negative test for interaction for TTPP (P = 0.997) and TTP (P = 0.749). Multivariable analysis did not show a significant association between genotype and TTP or TTPP.
CONCLUSIONS


The HSD3B1 (CC) genotype was associated with shorter TTP and lower PSA response rate in patients with mCRPC treated with abiraterone or enzalutamide. However, the CC genotype did not provide prognostic information beyond that conferred by standard clinical variables, suggesting that it may not be a suitable stand-alone biomarker in mCRPC.",2020,"CONCLUSIONS


HSD3B1 (CC) genotype was associated with shorter TTP and lower PSA response rate in mCRPC patients treated with abiraterone or enzalutamide.","['metastatic castration-resistant prostate cancer (mCRPC) treated with', 'metastatic castration-resistant prostate cancer patients treated with', 'men treated with androgen-deprivation therapy for metastatic castration-sensitive prostate cancer', '547 patients treated with']","['abiraterone + prednisone or enzalutamide', 'abiraterone and enzalutamide', 'abiraterone or enzalutamide']","['PSA response rate', 'PSA response rates', 'PSA response rate, time to PSA progression (TTPP), time to progression (TTP) and overall survival (OS', 'HSD3B1 variant genotype (CC', 'TTPP']","[{'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C0754011', 'cui_str': 'abiraterone'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}]","[{'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}]",547.0,0.123766,"CONCLUSIONS


HSD3B1 (CC) genotype was associated with shorter TTP and lower PSA response rate in mCRPC patients treated with abiraterone or enzalutamide.","[{'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Khalaf', 'Affiliation': 'BC Cancer Vancouver, Vancouver, BC, Canada.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Aragón', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Genitourinary Cancer Translational Research Unit, Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Annala', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada; Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lozano', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Genitourinary Cancer Translational Research Unit, Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Taavitsainen', 'Affiliation': 'Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lorente', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Hospital General Universitari de Castelló, Castellon, Spain.'}, {'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Finch', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada; BC Cancer Kelowna, Kelowna, BC, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Romero-Laorden', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Medical Oncology Department, Hospital Universitario La Princesa, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vergidis', 'Affiliation': 'BC Cancer Victoria, Victoria, BC, Canada.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Cendón', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Oja', 'Affiliation': 'BC Cancer Surrey, Surrey, BC, Canada.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Pacheco', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zulfiqar', 'Affiliation': 'BC Cancer Abbotsford, Abbotsford, BC, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Gleave', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Wyatt', 'Affiliation': 'Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Olmos', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Genitourinary Cancer Translational Research Unit, Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'BC Cancer Vancouver, Vancouver, BC, Canada; Vancouver Prostate Centre, Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Castro', 'Affiliation': 'Prostate Cancer Clinical Research Unit, Spanish National Cancer Research Centre (CNIO), Madrid, Spain; Genitourinary Cancer Translational Research Unit, Institute of Biomedical Research in Malaga (IBIMA), Malaga, Spain; Medical Oncology Department, Hospital Universitario Virgen de la Victoria y Regional de Málaga, Malaga, Spain. Electronic address: elena.castro@ibima.eu.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.06.006']
1261,32579785,Clinical phase II and III studies of an AS03-adjuvanted H5N1 influenza vaccine produced in an EB66 ®  cell culture platform.,"BACKGROUND


We have developed an AS03-adjuvanted H5N1 influenza vaccine produced in an EB66 ®  cell culture platform (KD-295).
OBJECTIVES


In accordance with Japanese guidelines for development of pandemic prototype vaccines, the phase II study was conducted in a double-blind, randomized, parallel-group comparison study and the phase III study was conducted in an open-label, non-randomized, uncontrolled study.
METHODS


Healthy adult volunteers aged 20 - 64 years enrolled in the phase II and III studies (N = 248 and N = 369) received KD-295 intramuscularly twice with a 21-day interval. After administration, immune response and adverse events were evaluated. In the phase II study, four different vaccine formulations were compared: MA (3.75 μg hemagglutinin [HA] antigen + AS03 adjuvant system), MB (3.75 μg HA + 1/2AS03), HA (7.5 μg HA + AS03), and HB (7.5 μg HA + 1/2AS03). In the phase III study, the MA formulation was further evaluated.
RESULTS


In the phase II study, all four vaccine formulations were well-tolerated and no SAE related to vaccination were observed. The MA formulation was slightly more immunogenic and less reactogenic among the vaccine formulations. Therefore, the MA formulation was selected for the phase III study, and it was well-tolerated and no serious adverse drug reactions were observed. The vaccine fulfilled the three immunogenicity criteria described in the Japanese guidelines.
CONCLUSIONS


These data indicate that the MA formulation of KD-295 was well-tolerated and highly immunogenic and it can be considered a useful pandemic and pre-pandemic influenza vaccine.",2020,"In the phase II study, all four vaccine formulations were well-tolerated and no SAE related to vaccination were observed.",['Healthy adult volunteers aged 20\xa0-\xa064\xa0years enrolled in the phase II and III studies (N\xa0=\xa0248 and N\xa0=\xa0369) received'],"['HA (7.5\xa0μg', 'KD-295 intramuscularly twice with a 21-day interval', 'MA (3.75\xa0μg hemagglutinin [HA] antigen\xa0+\xa0AS03 adjuvant system), MB', 'AS03-adjuvanted H5N1 influenza vaccine']","['tolerated and no serious adverse drug reactions', 'immune response and adverse events']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4517697', 'cui_str': '3.75'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C2934792', 'cui_str': 'ASO3B adjuvant'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2748361', 'cui_str': 'H5N1 influenza'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0138285,"In the phase II study, all four vaccine formulations were well-tolerated and no SAE related to vaccination were observed.","[{'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Endo', 'Affiliation': 'KM Biologics Co., Ltd. (KM Biologics), Kumamoto, Japan.'}, {'ForeName': 'Mitsuyoshi', 'Initials': 'M', 'LastName': 'Tanishima', 'Affiliation': 'KM Biologics Co., Ltd. (KM Biologics), Kumamoto, Japan.'}, {'ForeName': 'Kayo', 'Initials': 'K', 'LastName': 'Ibaragi', 'Affiliation': 'KM Biologics Co., Ltd. (KM Biologics), Kumamoto, Japan.'}, {'ForeName': 'Kenshi', 'Initials': 'K', 'LastName': 'Hayashida', 'Affiliation': 'KM Biologics Co., Ltd. (KM Biologics), Kumamoto, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Fukuda', 'Affiliation': 'KM Biologics Co., Ltd. (KM Biologics), Kumamoto, Japan.'}, {'ForeName': 'Tetsuro', 'Initials': 'T', 'LastName': 'Tanabe', 'Affiliation': 'KM Biologics Co., Ltd. (KM Biologics), Kumamoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Naruse', 'Affiliation': 'KM Biologics Co., Ltd. (KM Biologics), Kumamoto, Japan.'}, {'ForeName': 'Yoichiro', 'Initials': 'Y', 'LastName': 'Kino', 'Affiliation': 'Kino Consulting, Kumamoto, Japan.'}, {'ForeName': 'Kohji', 'Initials': 'K', 'LastName': 'Ueda', 'Affiliation': 'Kyushu University, Fukuoka, Japan.'}]",Influenza and other respiratory viruses,['10.1111/irv.12755']
1262,32536425,[The effect of thoracic paravertebral block on seroma reduction in breast surgery - a randomized controlled trial].,"BACKGROUND


Increasing number of patients are being operated because of breast cancer. Seroma is the most common problem that occurs after surgery that increases morbidity. For postoperative pain management, Thoracic Paravertebral Block (TPVB) has long been considered the gold standard technique. With performing TPVB, sympathetic nerves are also blocked.
OBJECTIVE


With this study, we aimed to search the effect of TPVB on seroma reduction in patients who undergo mastectomy and axillary node dissection surgery.
METHODS


Forty ASA I-II female patients aged 18-65, who were scheduled to go under elective unilateral mastectomy and axillary lymph node resection were included to the study. Patients were randomized into two groups as TPVB and control group. Ultrasound guided TPVB with 20 mL 0.25% bupivacaine was performed at T1 level preoperatively to the TPVB group patients. All patients were provided with i.v. patient-controlled analgesia device. Seroma formation amounts, morphine consumptions and Numeric Rating Scale (NRS) scores for pain were recorded 24 th  hour postoperatively.
RESULTS AND CONCLUSIONS


Mean seroma formation at postoperative 24 th  hour was 112.5±53.3 mL in the control group and 74.5±47.4 mL in the TPVB group (p=0.022). NRS scores were similar between two groups (p=0.367) at postoperative 24 th  hour but mean morphine consumption at postoperative 24 th  hour was 5.6±4 mg in the TPBV group, and 16.6±6.9 mg in the control group (p <0.001). TPVB reduces the amount of seroma formation while providing effective analgesia in patients who undergo mastectomy and axillary lymph node removal surgery.",2020,"NRS scores were similar between two groups (p=0.367) at postoperative 24 th  hour but mean morphine consumption at postoperative 24 th  hour was 5.6±4 mg in the TPBV group, and 16.6±6.9 mg in the control group (p <0.001).","['patients who undergo mastectomy and axillary lymph node removal surgery', 'patients who undergo mastectomy and axillary node dissection surgery', 'Forty ASA I-II female patients aged 18-65, who were scheduled to go under elective unilateral mastectomy and axillary lymph node resection were included to the study']","['thoracic paravertebral block', 'Ultrasound guided TPVB with 20 mL 0.25% bupivacaine', 'Thoracic Paravertebral Block (TPVB', 'TPVB']","['seroma reduction', 'Seroma formation amounts, morphine consumptions and Numeric Rating Scale (NRS) scores for pain', 'seroma formation', 'morbidity', 'Mean seroma formation', 'NRS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0024886', 'cui_str': 'Simple mastectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",40.0,0.0698048,"NRS scores were similar between two groups (p=0.367) at postoperative 24 th  hour but mean morphine consumption at postoperative 24 th  hour was 5.6±4 mg in the TPBV group, and 16.6±6.9 mg in the control group (p <0.001).","[{'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Kuş', 'Affiliation': 'Kocaeli University Hospital, Department of Anesthesiology and Reanimation, Kocaeli, Turquia.'}, {'ForeName': 'Ufuk H', 'Initials': 'UH', 'LastName': 'Yörükoğlu', 'Affiliation': 'Kocaeli University Hospital, Department of Anesthesiology and Reanimation, Kocaeli, Turquia. Electronic address: ufukyorukoglu@gmail.com.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'Aksu', 'Affiliation': 'Kocaeli University Hospital, Department of Anesthesiology and Reanimation, Kocaeli, Turquia.'}, {'ForeName': 'Saffet', 'Initials': 'S', 'LastName': 'Çınar', 'Affiliation': 'Kocaeli University Hospital, Department of General Surgery, Kocaeli, Turquia.'}, {'ForeName': 'Nuh Zafer', 'Initials': 'NZ', 'LastName': 'Cantürk', 'Affiliation': 'Kocaeli University Hospital, Department of General Surgery, Kocaeli, Turquia.'}, {'ForeName': 'Yavuz', 'Initials': 'Y', 'LastName': 'Gürkan', 'Affiliation': 'Kocaeli University Hospital, Department of Anesthesiology and Reanimation, Kocaeli, Turquia.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2019.12.015']
1263,32682994,Time limited eating in adolescents with obesity (time LEAd): Study protocol.,"BACKGROUND


Time limited eating (TLE) has been shown to be effective for weight loss and improvement of glycemic control in adults with obesity and type 2 diabetes (T2D), but has not been well studied in adolescents. TLE may be a more feasible, flexible and effective dietary intervention for adolescents because it removes the need for intensive counting of calories or macronutrients, and emphasizes eating during a specified time period.
OBJECTIVES


The aim of this study is to assess the feasibility of a TLE approach in adolescents with obesity using a continuous glucose monitor (CGM) to promote adherence to the intervention.
METHODS


We propose a prospective, randomized controlled trial, in 60 adolescents (ages 14-18) with obesity (BMI% ≥ 95th percentile). Youth will be randomized to one of three treatment groups for a 12-week intervention: Group 1) Low sugar and carbohydrate education (LSC, 5% of total daily calories from sugar (<35 g)/day; <90 g carbohydrate (CHO)/day) + blinded CGM (used to monitor adherence and glycemic outcomes without real time feedback), Group 2) LSC + TLE (16-h fast/8-h feed for 5 days per week) + blinded CGM, and Group 3) LSC + TLE+ real time feedback via CGM (to evaluate effect of providing CGM data on intervention efficacy). Outcomes will include change in total body fat (TBF) percentage measured on DEXA scan, BMI status and fasting blood glucose at 12 weeks compared to baseline.
CONCLUSIONS


TLE is a potentially powerful lifestyle intervention that could be readily integrated into pediatric weight management programs to optimize their impact and accelerate healthy changes.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT03954223.",2020,"TLE may be a more feasible, flexible and effective dietary intervention for adolescents because it removes the need for intensive counting of calories or macronutrients, and emphasizes eating during a specified time period.
","['60 adolescents (ages 14-18) with obesity (BMI%\u202f≥\u202f95th percentile', 'adolescents with obesity (time LEAd', 'adolescents with obesity using a', 'adults with obesity and type 2 diabetes (T2D']","['TLE approach', 'LSC\u202f+\u202fTLE', 'TLE', 'Low sugar and carbohydrate education (LSC, 5% of total daily calories from sugar (<35\u202fg)/day; <90\u202fg carbohydrate (CHO)/day)\u202f+\u202fblinded CGM', 'continuous glucose monitor (CGM']","['total body fat (TBF) percentage measured on DEXA scan, BMI status and fasting blood glucose']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332186', 'cui_str': 'Definite time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0439087', 'cui_str': '<90'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]","[{'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",,0.0740017,"TLE may be a more feasible, flexible and effective dietary intervention for adolescents because it removes the need for intensive counting of calories or macronutrients, and emphasizes eating during a specified time period.
","[{'ForeName': 'Alaina P', 'Initials': 'AP', 'LastName': 'Vidmar', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America. Electronic address: avidmar@chla.usc.edu.""}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Goran', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Naguib', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Fink', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Choo Phei', 'Initials': 'CP', 'LastName': 'Wee', 'Affiliation': 'CTSI Biostatics Core, Saban Research Institute, Los Angeles, CA, United States of America.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hegedus', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Kelleen', 'Initials': 'K', 'LastName': 'Lopez', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Gonzalez', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Raymond', 'Affiliation': ""Diabetes & Obesity Program, Center for Endocrinology, Diabetes and Metabolism, Department of Pediatrics, Children's Hospital Los Angeles and Keck School of Medicine of USC, Los Angeles, CA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106082']
1264,32546490,"Cost-utility analysis of antibiotic treatment in patients with chronic low back pain and Modic changes: results from a randomised, placebo-controlled trial in Norway (the AIM study).","OBJECTIVE


To evaluate the cost-utility of 100 days of antibiotics in patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment In patients with chronic low back pain and Modic changes (AIM) study.
DESIGN


A cost-utility analysis from a societal and healthcare perspective alongside a double-blinded, parallel group, placebo, multicentre trial.
SETTING


Hospital outpatient clinics at six hospitals in Norway. The main results from the AIM study showed a small effect in back-related disability in favour of the antibiotics group, and slightly larger in those with type I Modic changes, but this effect was below the pre-defined threshold for clinically relevant effect.
PARTICIPANTS


180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62) were randomised to antibiotic treatment (n=89) or placebo-control (n=91).
INTERVENTIONS


Oral treatment with either 750 mg amoxicillin or placebo three times daily for 100 days.
MAIN OUTCOME MEASURES


Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss measured in Euro (€1=NOK 10), in the intention-to-treat population. Cost-utility was expressed in incremental cost-effectiveness ratio (ICER).
RESULTS


Mean (SD) total cost was €21 046 (20 105) in the amoxicillin group and €19 076 (19 356) in the placebo group, mean difference €1970 (95% CI; -3835 to 7774). Cost per QALY gained was €24 625. In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained. Given these ICERs and a willingness-to-pay threshold of €27 500 (NOK 275 000), the probability of amoxicillin being cost-effective was 51%. Even when the willingness-to-pay threshold increased to €55 000, the probability of amoxicillin being cost-effective was never higher than 53%.
CONCLUSIONS


Amoxicillin treatment showed no evidence of being cost-effective for people with chronic LBP and Modic changes during 1-year follow-up.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov NCT02323412.",2020,"In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained.","['patients with chronic low back pain and Modic changes (AIM) study', '180 patients with chronic LBP, previous disc herniation and Modic changes type I (n=118) or type II (n=62', 'Hospital outpatient clinics at six hospitals in Norway', 'patients with chronic low back pain (LBP) and type I or II Modic changes included in the Antibiotic treatment', 'patients with chronic low back pain and Modic changes']","['Amoxicillin', 'placebo-control (n=91', 'amoxicillin', 'amoxicillin or placebo', 'antibiotics', 'antibiotic treatment', 'placebo']","['Cost-utility', 'Quality-adjusted life years (QALYs) by EuroQoL-5D over 12 months and costs for healthcare and productivity loss', 'Mean (SD) total cost', 'probability of amoxicillin being cost-effective', 'incremental cost-effectiveness ratio (ICER', 'healthcare consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0029916', 'cui_str': 'Hospital Outpatient Clinics'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",180.0,0.51751,"In those with type I Modic changes, the amoxicillin group had higher healthcare consumption than the placebo group, resulting in €39 425 per QALY gained.","[{'ForeName': 'Margreth', 'Initials': 'M', 'LastName': 'Grotle', 'Affiliation': 'Department of Research and Innovation, Oslo University Hospital, Oslo, Norway mgrotle@oslomet.no.'}, {'ForeName': 'Lars Christian', 'Initials': 'LC', 'LastName': 'Bråten', 'Affiliation': 'FORMI, Oslo University Hospital Ullevaal, Oslo, OSLO, Norway.'}, {'ForeName': 'Jens Ivar', 'Initials': 'JI', 'LastName': 'Brox', 'Affiliation': 'Physical Medicine and rehabilitation, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ansgar', 'Initials': 'A', 'LastName': 'Espeland', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Zinajda', 'Initials': 'Z', 'LastName': 'Zolic-Karlsson', 'Affiliation': 'Regional Research Support Services, Oslo University Hospital Ullevaal, Oslo, Norway.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Munk Killingmo', 'Affiliation': 'Department of Physiotherapy, Oslo Metropolitan University Faculty of Health Sciences, Oslo, Oslo, Norway.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Tingulstad', 'Affiliation': 'Department of Physiotherapy, Oslo Metropolitan University Faculty of Health Sciences, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Grøvle', 'Affiliation': 'Department of Rheumatology, Østfold Hospital Trust, Oslo, Oslo, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Froholdt', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Vestre Viken Hospital Trust, Drammen, Norway.'}, {'ForeName': 'Per Martin', 'Initials': 'PM', 'LastName': 'Kristoffersen', 'Affiliation': 'Department of Radiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Wigemyr', 'Affiliation': 'FORMI, Oslo University Hospital Ullevaal, Oslo, OSLO, Norway.'}, {'ForeName': 'Maurits W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Department of Health Sciences, VU University, Amsterdam, Netherlands.'}, {'ForeName': 'Kjersti', 'Initials': 'K', 'LastName': 'Storheim', 'Affiliation': 'Clinic for Surgery and Neurology, FORMI, Oslo, Norway.'}, {'ForeName': 'John-Anker', 'Initials': 'JA', 'LastName': 'Zwart', 'Affiliation': 'Department of Neurology and FORMI, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035461']
1265,32546493,Role of the intelligent exercise rehabilitation management system on adherence of cardiac rehabilitation in patients with coronary heart disease: a randomised controlled crossover study protocol.,"INTRODUCTION


The benefits of cardiac rehabilitation (CR) on the reduction of cardiac and all-cause mortality are well documented. However, adherence remains suboptimal in China. It is clear that traditional CR does not meet the needs of many eligible patients and innovation is required to improve its application. Home-based CR (HBCR) is a cost-effective method that may be a valuable alternative for many individuals in China. In HBCR, it is often difficult to maintain an exercise intensity that is both effective and within safe limits, factors that are essential for patient safety. Mobile health interventions have the potential to overcome these obstacles and may be efficacious in improving adherence. The purpose of this study is to evaluate whether an Intelligent Exercise Rehabilitation Management System (IERMS)-based HBCR could improve adherence to CR and to assess the effects on exercise capacity, mental health, self-efficacy, quality of life and lifestyle-related risk factors.
METHODS AND ANALYSIS


We propose a single-blinded, two-arm, randomised controlled crossover study of 70 patients with coronary heart disease (CHD). Participants will be randomly assigned in a 1:1 ratio to one of the two groups. Patients in group 1 will receive the IERMS intervention together with usual care for the first 6 weeks and usual care for the last 6 weeks, while patients assigned to group 2 will receive usual care for the first 6 weeks and will use IERMS in the last 6 weeks. The primary outcome is adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors. All secondary outcomes will be measured at baseline, 6 weeks and 12 weeks.
ETHICS AND DISSEMINATION


This study has been approved by the Human Research Ethics Committee of the School of Nursing, Jilin University (HREC 2019120901). The results will be published in peer-reviewed journals and at conferences.
TRIAL REGISTRATION NUMBER


ChiCTR1900028182; Pre-results.",2020,"The primary outcome is adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors.","['70 patients with coronary heart disease (CHD', 'patients with coronary heart disease']","['Home-based CR (HBCR', 'IERMS intervention together with usual care for the first 6\u2009weeks and usual care for the last 6\u2009weeks, while patients assigned to group 2 will receive usual care for the first 6\u2009weeks and will use IERMS', 'Intelligent Exercise Rehabilitation Management System (IERMS)-based HBCR', 'intelligent exercise rehabilitation management system', 'cardiac rehabilitation (CR']","['exercise capacity, mental health, self-efficacy, quality of life and lifestyle-related risk factors', 'adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors', 'adherence of cardiac rehabilitation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]",70.0,0.0831069,"The primary outcome is adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors.","[{'ForeName': 'Linqi', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Wenji', 'Initials': 'W', 'LastName': 'Xiong', 'Affiliation': 'The First Hospital of Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Jinwei', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Meidi', 'Initials': 'M', 'LastName': 'Shen', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Ni', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Yuewei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Lirong', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Lijing', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Jilin University, Changchun, Jilin, China lifeng2912@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-036720']
1266,32553835,Reductions in Parent Interest in Receiving Antibiotics following a 90-Second Video Intervention in Outpatient Pediatric Clinics.,"OBJECTIVES


To assess the impact of a 90-second animated video on parents' interest in receiving an antibiotic for their child.
STUDY DESIGN


This pre-post test study enrolled English and Spanish speaking parents (n = 1051) of children ages 1-5 years presenting with acute respiratory tract infection symptoms. Before meeting with their provider, parents rated their interest in receiving an antibiotic for their child, answered 6 true/false antibiotic knowledge questions, viewed the video, and then rated their antibiotic interest again. Parents rated their interest in receiving an antibiotic using a visual analogue scale ranging from 0 to 100, with 0 being ""I definitely do not want an antibiotic,"" 50 ""Neutral,"" and 100 ""I absolutely want an antibiotic.""
RESULTS


Parents were 84% female, with a mean age of 32 ± 6.0, 26.0% had a high school education or less, 15% were black, and 19% were Hispanic. After watching the video, parents' average antibiotic interest ratings decreased by 10 points (mean, 57.0 ± 20 to M ± 21; P < .0001). Among parents with the highest initial antibiotic interest ratings (≥60), even greater decreases were observed (83.0 ± 12.0 to 63.4 ± 22; P < .0001) with more than one-half (52%) rating their interest in the low or neutral ranges after watching the video.
CONCLUSIONS


A 90-second video can decrease parents' interest in receiving antibiotics, especially among those with higher baseline interest. This scalable intervention could be used in a variety of settings to reduce parents' interest in receiving antibiotics.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03037112.",2020,"Among parents with the highest initial antibiotic interest ratings (>60), even larger reductions were observed (M=83.0, SD=12 to M=63.4, SD=22; p<.0001) with over half (52%) rating their interest in the low or neutral ranges after watching the video.
","['This pre-post test study enrolled English and Spanish speaking parents (n=1051) of children ages 1-5 years presenting with acute respiratory tract infection symptoms', 'Parents were 84% female, mean age 32 (SD=6.0), 26.0% had a high school education or less, 15% Black, and 19% Hispanic', ""parents' interest in receiving an antibiotic for their child"", 'Outpatient Pediatric Clinics']",['90-second animated video'],[],"[{'cui': 'C0032919', 'cui_str': 'Pre-Post Tests'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C4759838', 'cui_str': 'Acute respiratory tract infection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839701', 'cui_str': 'Pediatric clinic'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0042655', 'cui_str': 'Video'}]",[],,0.0489348,"Among parents with the highest initial antibiotic interest ratings (>60), even larger reductions were observed (M=83.0, SD=12 to M=63.4, SD=22; p<.0001) with over half (52%) rating their interest in the low or neutral ranges after watching the video.
","[{'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City, MO; University of Missouri - Kansas City School of Medicine, Kansas City, MO; University of Missouri - Kansas City School of Pharmacy, Kansas City, MO. Electronic address: kgoggin@cmh.edu.""}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Hurley', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City, MO; University of Missouri - Kansas City School of Medicine, Kansas City, MO.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bradley-Ewing', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City, MO.""}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Bickford', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City, MO.""}, {'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Lee', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City, MO; University of Missouri - Kansas City School of Medicine, Kansas City, MO.""}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Pina', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City, MO.""}, {'ForeName': 'Evelyn Donis', 'Initials': 'ED', 'LastName': 'De Miranda', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City, MO.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Mackenzie', 'Affiliation': ""Health Services and Outcomes Research, Children's Mercy Hospitals and Clinics, Kansas City, MO.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Yu', 'Affiliation': 'Sunflower Medical Group, Kansas City, MO.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Weltmer', 'Affiliation': 'University of Missouri - Kansas City School of Medicine, Kansas City, MO.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Linnemayr', 'Affiliation': 'RAND Corporation, Santa Monica, CA.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': ""University of Missouri - Kansas City School of Medicine, Kansas City, MO; Emergency Department, Children's Mercy, Kansas City, MO.""}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Newland', 'Affiliation': ""Pediatric Infectious Disease, St. Louis Children's Hospital, St. Louis, MO.""}, {'ForeName': 'Angela L', 'Initials': 'AL', 'LastName': 'Myers', 'Affiliation': ""University of Missouri - Kansas City School of Medicine, Kansas City, MO; Pediatric Infectious Diseases, Children's Mercy, Kansas City, MO.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.06.027']
1267,32553868,"Synthetic Surfactant CHF5633 Compared with Poractant Alfa in the Treatment of Neonatal Respiratory Distress Syndrome: A Multicenter, Double-Blind, Randomized, Controlled Clinical Trial.","OBJECTIVE


To compare efficacy and safety of a new synthetic surfactant, CHF5633, enriched with surfactant proteins, SP-B and SP-C peptide analogues, with porcine surfactant, poractant alfa, for the treatment of respiratory distress syndrome in infants born preterm.
STUDY DESIGN


Neonates born preterm on respiratory support requiring fraction of inspired oxygen (FiO 2 ) ≥0.30 from 24 0/7  to 26 6/7  weeks and FiO 2  ≥0.35 from 27 0/7  to 29 6/7  weeks of gestation to maintain 88%-95% oxygen saturation were randomized to receive 200 mg/kg of CHF5633 or poractant alfa. If necessary, redosing was given at 100 mg/kg. Efficacy end points were oxygen requirement (FiO 2 , respiratory severity score [FiO 2  × mean airway pressure]) in the first 24 hours, 7 and 28 days, discharge home, and/or 36 weeks of postmenstrual age; mortality and bronchopulmonary dysplasia at 28 days and 36 weeks of PMA. Adverse events and immunogenicity were monitored for safety.
RESULTS


Of the 123 randomized neonates, 113 were treated (56 and 57 in CHF5633 and poractant alfa groups, respectively). In both arms, FiO 2  and respiratory severity score decreased from baseline at all time points (P < .001) with no statistically significant differences between groups. Rescue surfactant use (19 [33.9%] vs 17 [29.8%]), bronchopulmonary dysplasia (31 [55.4%] and 32 [56.1%]), and mortality at day 28 (4 [7.1%] and 3 [5.3%]) were similar in the CHF5633 and poractant alfa groups, respectively. In 2 (3.4%) and 1 (1.7%) neonates, adverse drug reactions were reported in CHF5633 and poractant alfa groups, respectively. No immunogenicity was detected.
CONCLUSIONS


Treatment with CHF5633 showed similar efficacy and safety as poractant alfa in neonates born preterm with moderate-to-severe respiratory distress syndrome.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT02452476.",2020,In both arms FiO 2  and RSS decreased from baseline at all timepoints (P < .001) with no statistically significant differences between groups.,"['Preterm neonates on respiratory support requiring fraction of inspired oxygen (FiO 2 ', 'respiratory distress syndrome (RDS) in preterm infants', '123 randomized neonates', 'preterm neonates with moderate to severe RDS', '≥0.30 from 24 0/7  to 26 6/7  weeks and FiO 2  ≥0.35 from 27 0/7  to 29 6/7  weeks gestation to maintain 88-95% oxygen saturation', 'Neonatal Respiratory Distress Syndrome']","['CHF5633 or PA', 'Poractant Alfa', 'CHF5633', 'Synthetic Surfactant CHF5633', 'new synthetic surfactant, CHF5633, enriched with surfactant proteins, SP-B and SP-C peptide analogues, with porcine surfactant, poractant alfa']","['BPD', 'adverse drug reactions', 'discharge home and/or 36-week postmenstrual age, mortality and bronchopulmonary dysplasia (BPD', 'efficacy and safety', 'mortality', 'Adverse events and immunogenicity', 'RSS', 'oxygen requirement [FiO 2 , Respiratory Severity Score (RSS) (FiO 2  x mean airway pressure']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]","[{'cui': 'C3885750', 'cui_str': 'CHF5633'}, {'cui': 'C0771648', 'cui_str': 'Poractant alfa'}, {'cui': 'C0038891', 'cui_str': 'Surfactant'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3544277', 'cui_str': 'Surfactant protein'}, {'cui': 'C0630744', 'cui_str': 'substance P, cyclo(H-Glu-Phe-Phe-Gly-Leu-Met-NH(CH2)3-NH-)'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0034085', 'cui_str': 'Lung surfactant'}]","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}]",,0.338415,In both arms FiO 2  and RSS decreased from baseline at all timepoints (P < .001) with no statistically significant differences between groups.,"[{'ForeName': 'Rangasamy', 'Initials': 'R', 'LastName': 'Ramanathan', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, LAC+USC Medical Center and Good Samaritan Hospital, Keck School of Medicine of USC, Los Angeles, CA. Electronic address: ramanath@usc.edu.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Biniwale', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, LAC+USC Medical Center and Good Samaritan Hospital, Keck School of Medicine of USC, Los Angeles, CA.'}, {'ForeName': 'Krishnamurthy', 'Initials': 'K', 'LastName': 'Sekar', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Oklahoma University Medical Center, Children's Hospital, University of Oklahoma Health Sciences Center, Oklahoma City, OK.""}, {'ForeName': 'Nazeeh', 'Initials': 'N', 'LastName': 'Hanna', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, NYU Winthrop Hospital, NYU Long Island School of Medicine, New York, NY.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Golombek', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Joseph M. Sanzari Children's Hospital at Hackensack University Medical Center, Hackensack, NJ.""}, {'ForeName': 'Jatinder', 'Initials': 'J', 'LastName': 'Bhatia', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, The Medical College of Georgia at Augusta University, Augusta, GA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Naylor', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Brody School of Medicine at East Carolina University, Greenville, NC.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Fabbri', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Varoli', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Santoro', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Del Buono', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Piccinno', 'Affiliation': 'Global Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.'}, {'ForeName': 'Christiane E', 'Initials': 'CE', 'LastName': 'Dammann', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Floating Hospital for Children at Tufts Medical Center, Boston, MA.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.06.024']
1268,32345594,Patients with Cancer Appear More Vulnerable to SARS-CoV-2: A Multicenter Study during the COVID-19 Outbreak.,"The novel COVID-19 outbreak has affected more than 200 countries and territories as of March 2020. Given that patients with cancer are generally more vulnerable to infections, systematic analysis of diverse cohorts of patients with cancer affected by COVID-19 is needed. We performed a multicenter study including 105 patients with cancer and 536 age-matched noncancer patients confirmed with COVID-19. Our results showed COVID-19 patients with cancer had higher risks in all severe outcomes. Patients with hematologic cancer, lung cancer, or with metastatic cancer (stage IV) had the highest frequency of severe events. Patients with nonmetastatic cancer experienced similar frequencies of severe conditions to those observed in patients without cancer. Patients who received surgery had higher risks of having severe events, whereas patients who underwent only radiotherapy did not demonstrate significant differences in severe events when compared with patients without cancer. These findings indicate that patients with cancer appear more vulnerable to SARS-CoV-2 outbreak. SIGNIFICANCE: Because this is the first large cohort study on this topic, our report will provide much-needed information that will benefit patients with cancer globally. As such, we believe it is extremely important that our study be disseminated widely to alert clinicians and patients. This article is highlighted in the In This Issue feature, p. 747 .",2020,"Patients who received surgery had higher risks of having severe events, whereas patients who underwent only radiotherapy did not demonstrate significant differences in severe events when compared with patients without cancer.","['patients with cancer', 'Patients with nonmetastatic cancer', '105 patients with cancer and 536 age-matched noncancer patients confirmed with COVID-19', 'patients with cancer globally', 'Patients with Cancer Appear More Vulnerable to SARS-CoV-2', 'Patients with hematologic cancer, lung cancer, or with metastatic cancer (stage IV']",['radiotherapy'],"['severe events', 'higher risks of having severe events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}]",105.0,0.0266972,"Patients who received surgery had higher risks of having severe events, whereas patients who underwent only radiotherapy did not demonstrate significant differences in severe events when compared with patients without cancer.","[{'ForeName': 'Mengyuan', 'Initials': 'M', 'LastName': 'Dai', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Dianbo', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ""Computational Health Informatics Program, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. chb21051@163.com msantill@g.harvard.edu mliu0@bwh.harvard.edu.""}, {'ForeName': 'Fuxiang', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Hubei Key Laboratory of Tumor Biological Behaviors, Wuhan, China.'}, {'ForeName': 'Guiling', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Cancer Center, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Emergency, The Central Hospital of Wuhan affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Zhian', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Gynecology, The Central Hospital of Huanggang, Huanggang, Hubei, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'You', 'Affiliation': 'Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, Guangdong Province, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Ultrasound, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Qichao', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Department of Ultrasound, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'Department of Infectious Disease, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Huihua', 'Initials': 'H', 'LastName': 'Xiong', 'Affiliation': 'Cancer Center, Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, The Central Hospital of Wuhan affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Changchun', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Hubei Cancer Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xiong', 'Affiliation': 'Department of Thoracic Surgery, Hubei Cancer Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Yaqin', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Obstetrics and Gynecology, Renmin Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Siping', 'Initials': 'S', 'LastName': 'Ge', 'Affiliation': 'Department of Oncology, Wuhan Puren Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhen', 'Affiliation': 'Department of Obstetrics and Gynecology, The Central Hospital of Xianning, Xianning, Hubei, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Department of Oncology, The Central Hospital of Xiaogan, Xiaogan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics and Gynecology, The People's Hospital of Huangmei, Huangmei, Hubei, China.""}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics and Gynecology, Xiangyang First People's Hospital affiliated to Hubei University of Medicine, Xiangyang, Hubei, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Hubei Key Laboratory of Tumor Biological Behaviors, Wuhan, China.'}, {'ForeName': 'Yeshan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Cancer Center, Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Junhua', 'Initials': 'J', 'LastName': 'Mei', 'Affiliation': 'Department of Gynecology, The Central Hospital of Huanggang, Huanggang, Hubei, China.'}, {'ForeName': 'Xiaojia', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Department of Oncology, The Central Hospital of Wuhan affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Zhuyan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Obstetrics and Gynecology, The People's Hospital of Shiyan, Shiyan, Hubei, China.""}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Gan', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Can', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Yuying', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Yuwen', 'Initials': 'Y', 'LastName': 'Qi', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China.'}, {'ForeName': 'Daniel G', 'Initials': 'DG', 'LastName': 'Tenen', 'Affiliation': 'Harvard Stem Cell Institute, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chai', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Lorelei A', 'Initials': 'LA', 'LastName': 'Mucci', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Dana-Farber, Harvard Cancer Center, Boston, Massachusetts.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Santillana', 'Affiliation': ""Computational Health Informatics Program, Boston Children's Hospital, Boston, Massachusetts. chb21051@163.com msantill@g.harvard.edu mliu0@bwh.harvard.edu.""}, {'ForeName': 'Hongbing', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Department of Gynecological Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China. chb21051@163.com msantill@g.harvard.edu mliu0@bwh.harvard.edu.'}]",Cancer discovery,['10.1158/2159-8290.CD-20-0422']
1269,32554218,Potential benefits of environmental volunteering programs of the health of older adults: a pilot study.,"PURPOSE


To study the effects of participating in a 12-week environmental volunteering program on the physical performance of older adults across different age groups MATERIALS AND METHODS: We conducted a pretest-posttest pilot study with a single group. The intervention consisted of twice-weekly recycling activities and once-weekly rehabilitation exercise at community-based care centers. The recycling activities of the environmental volunteering program included sorting and handling paper products, plastics, and metals; disposing electronic products; and sorting clothes. The rehabilitation exercise program comprised a 90-min course for special needs and 30 min of health education. The evaluation tools were the handgrip strength, five-times-sit-to-stand test, sit-and-reach test, Timed Up and Go (TUG) test and usual and fast gait speeds.
RESULTS


In total, 45 participants completed the program. After the program, the participants showed significantly great improvements compared to baseline in all outcome measures. We further divided these participants into two age subgroups [65-75 years (n = 31) and >75 years (n = 14)]. The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed. However, the >75-year subgroup showed significant improvements in all outcome measures.
CONCLUSIONS


This innovative environmental volunteering program conducted in a local Taiwanese community can be a sustainable and feasible model to improve physical performance in the participants, the subgroup aged >75 years in particular. It also provides a potential avenue for researchers and policymakers to address environmental and aging-related issues.",2020,"The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed.","['older adults across different age groups', 'older adults', 'participants into two age subgroups [65-75 years (n\u2009=\u200931) and >75 years (n\u2009=\u200914', 'participants, the subgroup aged >75 years in particular', '45 participants completed the program']","['twice-weekly recycling activities and once-weekly rehabilitation exercise at community-based care centers', 'rehabilitation exercise program', 'environmental volunteering program', 'environmental volunteering programs']","['handgrip strength, TUG and usual gait speed', 'handgrip strength, five-times-sit-to-stand test, sit-and-reach test, Timed Up and Go (TUG) test and usual and fast gait speeds']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0282114', 'cui_str': 'Recycling'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",45.0,0.0265483,"The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed.","[{'ForeName': 'Jia-Ching', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Qi-Xing', 'Initials': 'QX', 'LastName': 'Chang', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Chung-Chao', 'Initials': 'CC', 'LastName': 'Liang', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Department of Medicine, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Jyh-Gang', 'Initials': 'JG', 'LastName': 'Hsieh', 'Affiliation': 'Department of Family Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Peter Pin-Sung', 'Initials': 'PP', 'LastName': 'Liu', 'Affiliation': 'Center for Aging and Health, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Chia-Feng', 'Initials': 'CF', 'LastName': 'Yen', 'Affiliation': 'Department of Public Health, Tzu Chi University, Hualien, Taiwan. Electronic address: mapleyeng@gmail.com.'}, {'ForeName': 'Ching-Hui', 'Initials': 'CH', 'LastName': 'Loh', 'Affiliation': 'Department of Family Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Center for Aging and Health, Buddhist Tzu Chi General Hospital, Hualien, Taiwan. Electronic address: twdoc1960@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104113']
1270,32554291,Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial.,"OBJECTIVES


Pregnancy hypertension is associated with 7.1% of maternal deaths in India. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.
STUDY DESIGN


The Indian Community-Level Interventions for Pre-eclampsia (CLIP) open-label cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka. The CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4 h) or non-urgently (<24 h), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of mHealth-guided CHW-provided contacts.
MAIN OUTCOME MEASURES


20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.
RESULTS


All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up. The primary outcome did not differ between intervention and control arms (adjusted odds ratio (aOR) 0.92 [95% confidence interval 0.74, 1.15]; p = 0.47; intraclass correlation coefficient 0.013). There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals. Compared with intervention arm women without CLIP contacts, those with ≥8 contacts suffered fewer stillbirths (aOR 0.19 [0.10, 0.35]; p < 0.001), at the probable expense of survivable neonatal morbidity (aOR 1.39 [0.97, 1.99]; p = 0.072).
CONCLUSIONS


As implemented, solely community-level interventions focussed on pre-eclampsia did not improve outcomes in northwest Karnataka.",2020,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","['All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up', 'pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka', 'pre-eclampsia (CLIP) in India']","['CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4\xa0h) or non-urgently', 'task-sharing care', 'Community level interventions', 'methyldopa']","['safety and evaluation of the intensity of mHealth-guided CHW-provided contacts', 'survivable neonatal morbidity', 'composite of maternal, fetal, and newborn mortality and major morbidity']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0025741', 'cui_str': 'Methyldopa'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.32665,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","[{'ForeName': 'Mrutunjaya B', 'Initials': 'MB', 'LastName': 'Bellad', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India. Electronic address: mbbellad@hotmail.com.""}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Ashalata A', 'Initials': 'AA', 'LastName': 'Mallapur', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Umesh S', 'Initials': 'US', 'LastName': 'Charantimath', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Geetanjali M', 'Initials': 'GM', 'LastName': 'Katageri', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Umesh Y', 'Initials': 'UY', 'LastName': 'Ramadurg', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Global Affairs, 1020 Walnut Street, Thomas Jefferson University, Philadelphia 19107, USA.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Narayan V', 'Initials': 'NV', 'LastName': 'Honnungar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Chandrashekhar', 'Initials': 'C', 'LastName': 'Karadiguddi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Avinash J', 'Initials': 'AJ', 'LastName': 'Kavi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Bhalachandra S', 'Initials': 'BS', 'LastName': 'Kodkany', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Amit P', 'Initials': 'AP', 'LastName': 'Revankar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada; Aga Khan University, Stadium Road, P.O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.008']
1271,32559602,Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2.,"OBJECTIVE


To assess the efficacy of vilaprisan compared with placebo in the management of the symptoms of uterine fibroids (UF), with a secondary objective to provide a descriptive comparison with ulipristal acetate.
STUDY DESIGN


The randomized, parallel-group, double-blind, placebo- and active-controlled, multicenter ASTEROID 2 trial assessed the efficacy and safety of vilaprisan versus placebo and ulipristal acetate for two 12-week treatment periods in women with ≥1 UF experiencing heavy menstrual bleeding (HMB). The primary endpoint compared the efficacy of vilaprisan with placebo at 12 weeks, assessed as the absence of bleeding/spotting by bleeding diary. Secondary endpoints compared the efficacy of vilaprisan with ulipristal acetate. Results of the first 12-week treatment period are reported here.
RESULTS


Women (mean age 42.5 years) were enrolled from 1 June 2015. At baseline, mean menstrual blood loss per 28 days was 214.1 mL and the volume of the three largest UF was 106.2 mL. In total, 155 women completed the initial 12-week treatment period. Complete absence of bleeding/spotting until the end of the 12-week treatment period was achieved by 62.9 % of women receiving vilaprisan versus 0.0 % with placebo (p < .001); 55.4 % of women treated with ulipristal acetate reported absence of bleeding/spotting. The predefined HMB response (<80 mL and >50 % reduction from baseline during the last 28 days of treatment) was observed in 95.7 % of subjects treated with vilaprisan and 86.5 % of subjects treated with ulipristal acetate. Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group. No safety concerns, including multiple laboratory parameters, were identified.
CONCLUSION


Daily administration of vilaprisan 2 mg induced amenorrhea, controlled bleeding, decreased UF size, and was well tolerated in women with HMB associated with UF.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov number: NCT02465814 https://clinicaltrials.gov/ct2/show/NCT02465814.",2020,"Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group.","['women with ≥1 UF experiencing heavy menstrual bleeding (HMB', 'women with uterine fibroids', 'Women (mean age 42.5 years) were enrolled from 1 June 2015', '155 women completed the initial 12-week treatment period']","['Vilaprisan and ulipristal acetate', 'ulipristal acetate', 'vilaprisan versus placebo and ulipristal acetate', 'vilaprisan', 'placebo']","['mean menstrual blood loss', 'HMB response', 'Efficacy and safety', 'absence of bleeding/spotting by bleeding diary', 'Complete absence of bleeding/spotting', 'efficacy and safety', 'amenorrhea, controlled bleeding, decreased UF size', 'efficacy of vilaprisan', 'efficacy of vilaprisan with ulipristal acetate', 'absence of bleeding/spotting']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4508937', 'cui_str': 'vilaprisan'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C4508937', 'cui_str': 'vilaprisan'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}]",155.0,0.413833,"Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group.","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Karolinska University Hospital, S-171 76, Stockholm, Sweden. Electronic address: Kristina.Gemzell@ki.se.""}, {'ForeName': 'Oskari', 'Initials': 'O', 'LastName': 'Heikinheimo', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, PO Box 140, 00029-HUS, Helsinki, Finland. Electronic address: oskari.heikinheimo@helsinki.fi.'}, {'ForeName': 'Janos', 'Initials': 'J', 'LastName': 'Zatik', 'Affiliation': 'Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Magan Rendelo, 48 Szent Anna utca, Debrecen, Hungary. Electronic address: jzatik@yahoo.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Poka', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Debrecen, Nagyerdei krt. 98, 4032, Debrecen, Hungary. Electronic address: pokar@med.unideb.hu.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Rechberger', 'Affiliation': 'II Department of Gynecology, Medical University of Lublin, Racławickie 1 Street, 20-059, Lublin, Poland. Electronic address: rechbergt@yahoo.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hudecek', 'Affiliation': 'Department of Obstetrics and Gynecology, Brno University Hospital and Masaryk University Medical School, Jihlavská 20, CZ - 625 00, Brno, Czech Republic. Electronic address: hudecek.robert@fnbrno.cz.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Petersdorf', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Kathrin.petersdorf@bayer.com.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ramirez', 'Affiliation': 'Syneos Health, Frankfurter StraBe 233 Triforum, Haus C1 Neu-Isenburg, 63263, Germany. Electronic address: francisco.ramirez1.ext@bayer.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Faustmann', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: thomas.faustmann@bayer.com.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Groettrup-Wolfers', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Esther.groettrup-wolfers@bayer.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Seitz', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Christian.seitz@bayer.com.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.043']
1272,32559656,Can theory of mind be improved? Positive expectations cause better theory of mind performance in a community sample.,"BACKGROUND AND OBJECTIVES


Theory of Mind (ToM) deficits are present in several mental disorders and closely related to problems in social functioning and lower quality of life. While several trainings are aimed at improving ToM performance, it is unknown whether positive expectations on a persons' ToM performance might cause better ToM achievement.
METHODS


Participants (n = 131) first completed a mock ToM test and were then randomly assigned to either receive standardized positive, negative or no feedback on their ToM performance. Secondly, their expectations on their own ToM performance were assessed. Thirdly, ToM was assessed using the Movie Task for the Assessment of Social Cognition (MASC).
RESULTS


Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance.
LIMITATIONS


In the present exploratory study, the effect of positive expectations on ToM performance was assessed in a community sample. Thus, the study should be replicated in a clinical sample for more in-depth results.
CONCLUSIONS


ToM performance could be enhanced by inducing positive expectations on one's ToM performance, whereas negative feedback had no effect. The present study suggest that interventions that focus on strengthening positive expectations on one's ToM performance could enhance the efficacy of present ToM training methods.",2020,"RESULTS


Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance.
",['Participants (n\xa0'],"['standardized positive, negative or no feedback on their ToM performance']","['Movie Task for the Assessment of Social Cognition (MASC', 'enhanced ToM performance', 'ToM performance']",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}]","[{'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}]",131.0,0.0319971,"RESULTS


Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance.
","[{'ForeName': 'Laura M-L', 'Initials': 'LM', 'LastName': 'Dorn', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University, Marburg, Germany. Electronic address: laura.dorn@staff.uni-marburg.de.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University, Marburg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mehl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Philipps-University, Marburg, Germany; Department of Social Work and Health, Frankfurt University of Applied Sciences, Germany.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101577']
1273,32444264,Effect of Pharmacologic Prophylaxis on Venous Thromboembolism After Radical Prostatectomy: The PREVENTER Randomized Clinical Trial.,"BACKGROUND


Direct high-quality evidence is lacking evaluating perioperative pharmacologic prophylaxis (PP) after radical prostatectomy (RP) to prevent venous thromboembolism (VTE) leading to significant practice variation.
OBJECTIVE


To study the impact of in-hospital PP on symptomatic VTE incidence and adverse events after RP at 30 d, with the secondary objective of evaluating overall VTE in a screening subcohort.
DESIGN, SETTING, AND PARTICIPANTS


A prospective, phase 4, single-center, randomized trial of men with prostate cancer undergoing open or robotic-assisted laparoscopic RP was conducted (July 2017-November 2018).
INTERVENTION


PP (subcutaneous heparin) plus routine care versus routine care alone. The screening subcohort was offered lower extremity duplex ultrasound at 30 d.
OUTCOMES MEASUREMENTS AND STATISTICAL ANALYSIS


The primary efficacy outcome was symptomatic VTE incidence (pulmonary embolism [PE] or deep venous thrombosis [DVT]). Primary safety outcomes included the incidence of symptomatic lymphocele, hematoma, or bleeding after surgery. Secondary outcomes were overall VTE, estimated blood loss, total surgical drain output, complications, and surveillance imaging bias. Fisher's exact test and modified Poisson regression were performed.
RESULTS AND LIMITATIONS


A total of 501 patients (75% robotic) were randomized and >99% (500/501) completed follow-up. At second interim analysis (N = 445), the symptomatic VTE rate was 2.3% (four PE + DVT and one DVT) for routine care versus 0.9% (one PE + DVT and one DVT) for PP (relative risk 0.40 [95% confidence interval 0.08-2.03], p = 0.3) meeting a futility threshold for early stopping. In the screening subcohort, the overall VTE rate was 3.3% versus 2.4% (p = 0.7). Results were similar at the final analysis (symptomatic VTE: 2.0% vs 0.8%, p = 0.3; overall VTE: 2.9% vs 2.8%, p = 1). No differences were observed in safety or secondary outcomes. All VTE events (seven symptomatic and three asymptomatic) occurred in patients undergoing pelvic lymph node dissection.
CONCLUSIONS


This study was not able to demonstrate a statistically significant reduction in symptomatic VTE associated with PP. There was no increase in the development of symptomatic lymphoceles, bleeding, or other adverse events. Given that the event rate was lower than powered for, further research is needed among high-risk patients (Caprini score ≥8) or patients receiving pelvic lymph node dissection.
PATIENT SUMMARY


In this report, we randomized patients undergoing radical prostatectomy to perioperative pharmacologic prophylaxis or routine care alone. We found that pharmacologic prophylaxis did not reduce postoperative symptomatic venous thromboembolism significantly for men at routine risk. Importantly, pharmacologic prophylaxis did not increase adverse events, such as formation of lymphoceles or bleeding, and can safely be implemented when indicated for patients with risk factors undergoing radical prostatectomy.",2020,"Importantly, pharmacologic prophylaxis did not increase adverse events, such as formation of lymphoceles or bleeding, and can safely be implemented when indicated for patients with risk factors undergoing radical prostatectomy.","['men with prostate cancer undergoing open or', 'patients undergoing', 'patients with risk factors undergoing radical prostatectomy', '501 patients (75% robotic']","['Radical Prostatectomy', 'robotic-assisted laparoscopic RP', 'radical prostatectomy (RP', 'Pharmacologic Prophylaxis', 'radical prostatectomy to perioperative pharmacologic prophylaxis or routine care alone', 'PP (subcutaneous heparin) plus routine care versus routine care alone']","['overall VTE rate', 'symptomatic VTE rate', 'incidence of symptomatic lymphocele, hematoma, or bleeding after surgery', 'postoperative symptomatic venous thromboembolism', 'development of symptomatic lymphoceles, bleeding, or other adverse events', 'adverse events', 'symptomatic VTE incidence (pulmonary embolism [PE] or deep venous thrombosis [DVT', 'formation of lymphoceles or bleeding', 'Venous Thromboembolism', 'overall VTE, estimated blood loss, total surgical drain output, complications, and surveillance imaging bias']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024248', 'cui_str': 'Lymphocele'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2607832', 'cui_str': 'Surgical drain'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0005346', 'cui_str': 'Biases'}]",501.0,0.14869,"Importantly, pharmacologic prophylaxis did not increase adverse events, such as formation of lymphoceles or bleeding, and can safely be implemented when indicated for patients with risk factors undergoing radical prostatectomy.","[{'ForeName': 'Hiten D', 'Initials': 'HD', 'LastName': 'Patel', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: hitenpatel@jhmi.edu.'}, {'ForeName': 'Farzana A', 'Initials': 'FA', 'LastName': 'Faisal', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Trock', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Joice', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Zeyad R', 'Initials': 'ZR', 'LastName': 'Schwen', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Phillip M', 'Initials': 'PM', 'LastName': 'Pierorazio', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Johnson', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Trinity J', 'Initials': 'TJ', 'LastName': 'Bivalacqua', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Misop', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gorin', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'H Ballentine', 'Initials': 'HB', 'LastName': 'Carter', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Partin', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Christian P', 'Initials': 'CP', 'LastName': 'Pavlovich', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Mohamad E', 'Initials': 'ME', 'LastName': 'Allaf', 'Affiliation': 'The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}]",European urology,['10.1016/j.eururo.2020.05.001']
1274,32446108,Cortisol awakening response in PTSD treatment: Predictor or mechanism of change.,"PTSD is associated with abnormalities in hypothalamic-pituitary-adrenal (HPA) axis activity. This includes enhanced HPA axis negative feedback, attenuated cortisol awakening response, and attenuated cortisol response to personal trauma script. Whether HPA axis function predicts treatment response or treatment related symptom reduction in PTSD remains unclear. In addition, the relative effects of different treatment modalities (i.e., medication and psychotherapy) on HPA axis is unclear. To address this gap in knowledge, the PROGrESS study examined cortisol awakening response across treatment in Veterans with chronic PTSD randomized to receive Prolonged Exposure + Placebo (PE + PLB), Sertraline + PE (SERT + PE) or Sertraline + Enhanced Medication Management (SERT + EMM). Salivary cortisol awakening response (CAR) was assessed at baseline, mid-treatment (week 6 and 12), post-treatment (week 24) and follow-up (week 36 and 52). Among males at baseline, combat veterans with PTSD showed lower CAR Area Under the Curve Increase (AUCi; M = 3.15, SD = 9.57) than Combat controls (M = 7.63, SD = 9.07; p = .02), demonstrating combat veterans with PTSD have a less responsive system than combat controls. Higher PTSD severity was also related to lower CAR AUCi (r = -0.52, p = .03). When controlling for PTSD severity, higher baseline CAR AUCi was related to attenuated reduction in PTSD and lower likelihood of high treatment response over treatment (z = -2.06, p = .04).",2020,"Higher PTSD severity was also related to lower CAR AUCi (r = -0.52, p = .03).",['Veterans with chronic PTSD'],"['Prolonged Exposure + Placebo (PE + PLB), Sertraline + PE (SERT + PE) or Sertraline + Enhanced Medication Management (SERT + EMM']","['lower CAR Area Under the Curve Increase (AUCi', 'enhanced HPA axis negative feedback, attenuated cortisol awakening response', 'cortisol awakening response', 'Salivary cortisol awakening response (CAR', 'Cortisol awakening response', 'Higher PTSD severity', 'CAR AUCi']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0730525', 'cui_str': 'Chronic post-traumatic stress disorder'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}]","[{'cui': 'C0740379', 'cui_str': 'Cortisol decreased'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0100699,"Higher PTSD severity was also related to lower CAR AUCi (r = -0.52, p = .03).","[{'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Atlanta VA Healthcare System, 1670 Clairmont Road, Decatur, GA, 30033, Georgia; Emory University School of Medicine, 12 Executive Park, 3rdFloor, Atlanta, GA, 30029, Georgia. Electronic address: sheila.a.m.rauch@emory.edu.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'King', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI, 48109, United States.'}, {'ForeName': 'H Myra', 'Initials': 'HM', 'LastName': 'Kim', 'Affiliation': 'University of Michigan, Consulting for Statistics, Computing and Analytics Research, 3550 Rackham, 950 E. Washington Street, Ann Arbor, MI, 48109, United States.'}, {'ForeName': 'Corey', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'University of Michigan, Consulting for Statistics, Computing and Analytics Research, 3550 Rackham, 950 E. Washington Street, Ann Arbor, MI, 48109, United States.'}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Rajaram', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Venners', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States; National Center for PTSD, Dissemination and Training Division, 795 Willow Road, Menlo Park, CA 94025, United States.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'New York University Medical School, Department of Psychiatry, One Park Avenue 8thFloor, New York, NY 10016, United States; Massachusetts General Hospital, Department of Psychiatry, One Bowdoin Square, 6th Floor, Boston, MA 02114, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hamner', 'Affiliation': 'Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston, SC, 29401, United States; Medical University of South Carolina, Department of Psychiatry, 67 President Street, Charleston, SC 29425, United States.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI, 48109, United States; Texas A&M Health Science Center, Department of Psychiatry and Behavioral Science, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104714']
1275,32544846,"A fructose-based meal challenge to assess metabotypes and their metabolic risk profile: A randomized, crossover, controlled trial.","OBJECTIVES


The first aim of this study was to determine the metabolic type of individuals based on the postprandial metabolic response after the ingestion of a meal challenge that was high protein and either high glucose (high GI) or fructose (low GI). The second aim was to compare the baseline characteristics between the different metabolic types (metabotypes). The third aim was to assess whether the inclusion of fructose or glucose in a high-protein breakfast modulated the glucose, insulin, and TG response over a 4-h period.
METHODS


The study included 46 Asian women with a body mass index between 17 and 28 kg/m 2  in a randomized crossover design. Metabolic typing was based on the assessment of the postprandial glycemic, insulin and triacylglycerol (TG) response after the ingestion of two high-protein meal challenges either high in fructose or glucose. Baseline characteristics were compared between the different metabolic types. Baseline and 4-h postprandial blood samples were collected and glucose, insulin, and TG levels were analyzed. Cluster analysis was used to phenotype the participants in distinct groups. Baseline characteristics including anthropometry, glycemic, and lipid profiles and resting metabolic rate were compared among the metabolic types.
RESULTS


Cluster analysis revealed that women could be grouped into three metabolic types based on postprandial glucose, insulin, and TG response after the fructose meal challenge: cluster 1 with an average glucose + high TG response (highTG; n = 12), cluster 2 with a high glucose + average TG response (highGLU; n = 8), and cluster 3 with an average glucose + average TG response (Avg; n = 26). Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
CONCLUSIONS


Three metabolic types with a distinct metabolic response could be distinguished after a high fructose meal. The results suggest a different risk profile and may indicate why some people develop diabetes in an obesogenic environment. Improved metabolic-type assessments will enable us to develop and optimize nutritional and medical interventions for individuals with differing diabetes risk.",2020,"Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
","['46 Asian women with a body mass index between 17 and 28 kg/m 2', 'individuals with differing diabetes risk']","['high glucose (high GI) or fructose (low GI', 'fructose-based meal challenge']","['waist-to-hip ratio', 'fasting blood glucose, body mass index, fat percentage, and hip circumference', 'glucose, insulin, and TG levels', 'glucose, insulin, and TG response', 'postprandial glycemic, insulin and triacylglycerol (TG) response', 'Baseline and 4-h postprandial blood samples', 'postprandial glucose, insulin, and TG response', 'anthropometry, glycemic, and lipid profiles and resting metabolic rate', 'postprandial metabolic response']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}]",46.0,0.0341195,"Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster.
","[{'ForeName': 'Stefan Gerardus', 'Initials': 'SG', 'LastName': 'Camps', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Huann Rong', 'Initials': 'HR', 'LastName': 'Koh', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Nan Xin', 'Initials': 'NX', 'LastName': 'Wang', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore; Department of Biochemistry, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: jeya_henry@sifbi.a-star.edu.sg.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110799']
1276,32544854,Effect of ZNF804A gene polymorphism (rs1344706) on the plasticity of the functional coupling between the right dorsolateral prefrontal cortex and the contralateral hippocampal formation.,"ZNF804A has now been recognized as a schizophrenia risk gene by multiple genome-wide association studies with its intronic polymorphism rs1344706 being reported as the first genome-wide significant risk variant for schizophrenia. Although the functional impact of this gene is still unknown, rs1344706's contribution to the functional coupling between the right dorsolateral prefrontal cortex (DLPFC) and the contralateral hippocampal formation (HF) has been reported by several studies. The current study tested whether the right DLPFC-left HF functional coupling showed plasticity during cognitive training (Study I) and whether rs1344706 affected the plasticity (Study II). In Study I, we conducted a randomized controlled trial with 30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group). All subjects were scanned using fMRI before and after the training. Analyses of resting-state and task-state fMRI data consistently showed that the adaptive memory span training significantly strengthened the right DLPFC-left HF functional coupling. In Study II, we conducted a genetic association study with 101 subjects (combining the data from the training group in Study I with those from an additional subsequent sample of 71 subjects who received the same training and fMRI scans). Results showed that rs1344706 was significantly associated with training-induced changes in functional coupling. Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes. These findings expanded our current understanding of the functional impact of the schizophrenia risk variant of ZNF804A gene and suggested that the ZNF804A gene could be used as a prospective target for future antipsychotic drugs and clinical research.",2020,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"['101 subjects (combining the data from the training group in Study', '71 subjects who received the same training and fMRI scans', '30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group']","['ZNF804A', 'ZNF804A gene polymorphism (rs1344706']",['functional coupling'],"[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}]",101.0,0.0118036,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"[{'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiongying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qiumei', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China; School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Boqi', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Yu-Tao', 'Initials': 'YT', 'LastName': 'Xiang', 'Affiliation': 'Faculty of Health Sciences, University of Macau, Avenida da Universidade, Taipa, Macau, PR China.'}, {'ForeName': 'Chuanyue', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dong', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Chuansheng', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, CA 92697, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China. Electronic address: lijundp@bnu.edu.cn.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102279']
1277,32544925,Selective kappa-opioid antagonism ameliorates anhedonic behavior: evidence from the Fast-fail Trial in Mood and Anxiety Spectrum Disorders (FAST-MAS).,"Anhedonia remains a major clinical issue for which there is few effective interventions. Untreated or poorly controlled anhedonia has been linked to worse disease course and increased suicidal behavior across disorders. Taking a proof-of-mechanism approach under the auspices of the National Institute of Mental Health FAST-FAIL initiative, we were the first to show that, in a transdiagnostic sample screened for elevated self-reported anhedonia, 8 weeks of treatment with a kappa-opioid receptor (KOR) antagonist resulted in significantly higher reward-related activation in one of the core hubs of the brain reward system (the ventral striatum), better reward learning in the Probabilistic Reward Task (PRT), and lower anhedonic symptoms, relative to 8 weeks of placebo. Here, we performed secondary analyses of the PRT data to investigate the putative effects of KOR antagonism on anhedonic behavior with more precision by using trial-level model-based Bayesian computational modeling and probability analyses. We found that, relative to placebo, KOR antagonism resulted in significantly higher learning rate (i.e., ability to learn from reward feedback) and a more sustained preference toward the more frequently rewarded stimulus, but unaltered reward sensitivity (i.e., the hedonic response to reward feedback). Collectively, these findings provide novel evidence that in a transdiagnostic sample characterized by elevated anhedonia, KOR antagonism improved the ability to modulate behavior as a function of prior rewards. Together with confirmation of target engagement in the primary report (Krystal et al., Nat Med, 2020), the current findings suggest that further transdiagnostic investigation of KOR antagonism for anhedonia is warranted.",2020,"We found that, relative to placebo, KOR antagonism resulted in significantly higher learning rate (i.e., ability to learn from reward feedback) and a more sustained preference toward the more frequently rewarded stimulus, but unaltered reward sensitivity (i.e., the hedonic response to reward feedback).",[],"['placebo, KOR antagonism', 'KOR antagonism', 'placebo']","['learning rate (i.e., ability to learn from reward feedback']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0064239', 'cui_str': 'kappa Opioid Receptor'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0233832', 'cui_str': 'Learning ability'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",,0.0633681,"We found that, relative to placebo, KOR antagonism resulted in significantly higher learning rate (i.e., ability to learn from reward feedback) and a more sustained preference toward the more frequently rewarded stimulus, but unaltered reward sensitivity (i.e., the hedonic response to reward feedback).","[{'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'McLean Hospital, Harvard Medical School, Belmont, MA, USA. dap@mclean.harvard.edu.'}, {'ForeName': 'Moria', 'Initials': 'M', 'LastName': 'Smoski', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yuen-Siang', 'Initials': 'YS', 'LastName': 'Ang', 'Affiliation': 'McLean Hospital, Harvard Medical School, Belmont, MA, USA.'}, {'ForeName': 'Alexis E', 'Initials': 'AE', 'LastName': 'Whitton', 'Affiliation': 'School of Medical Sciences, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Nurnberger', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Hongqiu', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Weiner', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Case Western Reserve School of Medicine, Cleveland, OH, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Goodman', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'William Z', 'Initials': 'WZ', 'LastName': 'Potter', 'Affiliation': 'National Institute of Mental Health, Bethesda, MD, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Krystal', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0738-4']
1278,32553151,"Novel antisense inhibition of diacylglycerol O-acyltransferase 2 for treatment of non-alcoholic fatty liver disease: a multicentre, double-blind, randomised, placebo-controlled phase 2 trial.","BACKGROUND


Diacylglycerol-O-acyltransferase 2 (DGAT2) is one of two enzyme isoforms that catalyse the final step in the synthesis of triglycerides. IONIS-DGAT2 Rx  is an antisense oligonucleotide inhibitor of DGAT2 that is under clinical investigation for the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The aim of this trial was to examine the safety, tolerability, and efficacy of IONIS-DGAT2 Rx  versus placebo in reducing liver fat in patients with type 2 diabetes and NAFLD.
METHODS


This double-blind, randomised, placebo-controlled, phase 2 study consisted of a 2-week screening period, a run-in period of up to 4 weeks, a 13-week treatment period of once-weekly dosing, and a 13-week post-treatment follow-up period. The study was done at 16 clinical research sites in Canada, Poland, and Hungary. Eligible participants were aged 18-75 years, had a body-mass index at screening between 27 kg/m 2  and 39 kg/m 2 , haemoglobin A 1c  (HbA 1c ) levels from 7·3% to 9·5%, and liver fat content 10% or greater before randomisation, and agreed to maintain a stable diet and exercise routine throughout the study. Enrolled participants were stratified on the basis of liver fat content during the run-in period (<20% or ≥20%) and then centrally randomised (2:1) to receive once weekly subcutaneous injection of 250 mg IONIS-DGAT2 Rx  or placebo for 13 weeks. Participants, investigators, funder personnel, and the clinical research organisation staff, including central readers of MRI scans, were all masked to treatment identity. The primary endpoints were the safety, tolerability, and pharmacodynamic effect of IONIS-DGAT2 Rx  on hepatic steatosis, according to absolute reduction from baseline in liver fat percentage as quantified by MRI-estimated proton density fat fraction and assessed in the per-protocol population. Pharmacodynamic performance was determined in the per-protocol population by the change in liver fat content from baseline to 2 weeks after the last dose. The per-protocol population included all randomised participants who received at least ten doses of study drug, with the first four doses administered in the first 5 weeks, did not miss more than three consecutive weekly doses, and who had no protocol deviations that might affect efficacy. All randomised participants who received at least one dose of study drug were included in the safety analysis. This study is registered with ClinicalTrials.gov, NCT03334214.
FINDINGS


Between Nov 3, 2017, and Nov 28, 2018, we screened 173 people for eligibility. 44 were enrolled and randomly assigned to receive either IONIS-DGAT2 Rx  (29 participants) or placebo (15 participants). After 13 weeks of treatment, the mean absolute reduction from baseline was -5·2% (SD 5·4) in the IONIS-DGAT2 Rx  group compared with -0·6% (6·1) in the placebo group (treatment difference -4·2%, 95% CI -7·8 to -0·5, p=0·026). Reductions in liver fat were not accompanied by hyperlipidaemia, elevations in serum aminotransferases or plasma glucose, changes in bodyweight, or gastrointestinal side-effects compared with placebo. Six serious adverse events occurred in four patients treated with IONIS-DGAT2 Rx . No serious adverse events were reported in the placebo group. One of four patients reported three serious adverse events: acute exacerbation of chronic obstructive pulmonary disease, cardiac arrest, and ischaemic cerebral infarction, each considered severe and not related to study drug. Three of four patients reported one serious adverse event of increased blood triglycerides (severe, unrelated to study drug), deep-vein thrombosis (severe, unlikely to be related to study drug), and acute pancreatitis (mild, unrelated to study drug).
INTERPRETATION


Our results suggest that DGAT2 antisense inhibition could be a safe and efficacious strategy for treatment of NAFLD and support further investigation in patients with biopsy-proven NASH. Based on the pharmacological target, the response to treatment observed in this study population could extend to the broader population of patients with NAFLD.
FUNDING


Ionis Pharmaceuticals.",2020,"Reductions in liver fat were not accompanied by hyperlipidaemia, elevations in serum aminotransferases or plasma glucose, changes in bodyweight, or gastrointestinal side-effects compared with placebo.","['Between Nov 3, 2017, and Nov 28, 2018', '16 clinical research sites in Canada, Poland, and Hungary', 'non-alcoholic fatty liver disease', 'patients with biopsy-proven NASH', 'Eligible participants were aged 18-75 years, had a body-mass index at screening between 27 kg/m 2  and 39 kg/m 2 , haemoglobin A 1c  (HbA 1c ) levels from 7·3% to 9·5%, and liver fat content 10% or greater before randomisation, and agreed to maintain a stable diet and exercise routine throughout the study', '173 people for eligibility', 'patients with type 2 diabetes and NAFLD']","['IONIS-DGAT2', 'subcutaneous injection of 250 mg IONIS-DGAT2', 'diacylglycerol O-acyltransferase', 'Rx  versus placebo', 'placebo']","['liver fat', 'Six serious adverse events', 'Pharmacodynamic performance', 'safety, tolerability, and pharmacodynamic effect of IONIS-DGAT2', 'serious adverse events', 'safety, tolerability, and efficacy', 'blood triglycerides (severe, unrelated to study drug), deep-vein thrombosis (severe', 'serum aminotransferases or plasma glucose, changes in bodyweight, or gastrointestinal side-effects', 'serious adverse events: acute exacerbation of chronic obstructive pulmonary disease, cardiac arrest, and ischaemic cerebral infarction']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0163260', 'cui_str': 'Diacylglycerol acyltransferase'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0163260', 'cui_str': 'Diacylglycerol acyltransferase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518018', 'cui_str': 'Blood triglycerides'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C1262005', 'cui_str': 'Ischaemic cerebral infarction'}]",44.0,0.583485,"Reductions in liver fat were not accompanied by hyperlipidaemia, elevations in serum aminotransferases or plasma glucose, changes in bodyweight, or gastrointestinal side-effects compared with placebo.","[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Research Center, Division of Gastroenterology, University of California at San Diego, La Jolla, CA, USA. Electronic address: roloomba@ucsd.edu.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Morgan', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Lynnetta', 'Initials': 'L', 'LastName': 'Watts', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Hannan', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Geary', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Brenda F', 'Initials': 'BF', 'LastName': 'Baker', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Bhanot', 'Affiliation': 'Ionis Pharmaceuticals, Carlsbad, CA, USA.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30186-2']
1279,32556371,Multi-session anodal transcranial direct current stimulation enhances lower extremity functional performance in healthy older adults.,"The aim of this study was to examine the effects of 5 days of anodal-transcranial direct current stimulation (a-tDCS) over the primary motor cortex (M1) on lower extremity functional performance in healthy elderly people. This was a randomized, double-blinded, sham-controlled study whereby 32 healthy older individuals participated in two groups. The intervention group received 20 min of a-tDCS (1 mA) over the M1 on five consecutive days. The sham group received the same stimulation, but the tDCS device was turned off after 30 s of stimulation. Participants were asked to perform the Timed Up and Go (TUG), 30-s Chair Stand Test (30-s CST), and a Modified Figure of Eight Walk Test (MFEWT) on the first day before tDCS application, immediately, 30 min, and 1 week after the last session of stimulation. Results of the a-tDCS group showed that most of the test values had significant changes in post-test assessments compared to the pre-test (p < 0.05). When comparing the anodal and sham tDCS groups, the results showed a significant improvement in TUG and time-MFEWT immediately after (p = 0.02, p = 0.01), 30 min after (p = 0.04, p = 0.01) and 1 week after the last session of stimulation (p = 0.01, p = 0.01). Improvements in performance of the 30-s CST and the number of steps-MFEWT were not significant, except at 1 week after the last session for the steps-MFEWT (p = 0.04). The application of 20 min a-tDCS over the M1 for 5 consecutive days improves lower extremity functional performance in the healthy older participants.",2020,"Improvements in performance of the 30-s CST and the number of steps-MFEWT were not significant, except at 1 week after the last session for the steps-MFEWT (p = 0.04).","['32 healthy older individuals participated in two groups', 'healthy older adults', 'healthy elderly people', 'healthy older participants']","['20\xa0min of a-tDCS', 'primary motor cortex (M1', 'Multi-session anodal transcranial direct current stimulation', 'anodal-transcranial direct current stimulation (a-tDCS', 'Timed Up and Go (TUG), 30-s Chair Stand Test (30-s CST), and a Modified Figure of Eight Walk Test (MFEWT']","['number of steps-MFEWT', 'extremity functional performance', 'TUG and time-MFEWT']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",32.0,0.065157,"Improvements in performance of the 30-s CST and the number of steps-MFEWT were not significant, except at 1 week after the last session for the steps-MFEWT (p = 0.04).","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Rostami', 'Affiliation': 'Department of Physiotherapy, Research Center on Aging, University of Social Welfare and Rehabilitation Sciences, Tehran, 1985713831, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'Department of Physiotherapy, Research Center on Aging, University of Social Welfare and Rehabilitation Sciences, Tehran, 1985713831, Iran. zmosallanezhad@yahoo.com.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'Speech Therapy Department, Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ehsani', 'Affiliation': 'Neuromuscular Rehabilitation Research Centre, Semnan University of Medical Science, Semnan, Iran.'}, {'ForeName': 'Dawson', 'Initials': 'D', 'LastName': 'Kidgell', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Nourbakhsh', 'Affiliation': 'Department of Physical Therapy, University of North Georgia, Dahlonega, GA, USA.'}, {'ForeName': 'Enayatollah', 'Initials': 'E', 'LastName': 'Bakhshi', 'Affiliation': 'Department of Biostatistics, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Department of Physiotherapy, School of Primary Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}]",Experimental brain research,['10.1007/s00221-020-05827-6']
1280,32553932,The Second Strategic Reperfusion Early After Myocardial Infarction (STREAM-2) study optimizing pharmacoinvasive reperfusion strategy in older ST-elevation myocardial infarction patients.,"BACKGROUND


The STREAM study demonstrated that a pharmaco-invasive strategy was at least as effective as primary PCI (pPCI) in patients presenting early with ST-elevation myocardial infarction (STEMI). The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase. Additionally, a subsequent analysis of full dose tenecteplase or alteplase in the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT) trials demonstrated a steep increase in bleeding events beginning around the age of 60 years.
METHODS


STREAM-2 will compare the efficacy and safety of a novel pharmaco-invasive strategy as compared to routine pPCI in STEMI patients ≥60 years presenting within 3 hours from symptom onset. In the pharmaco-invasive arm patients will receive half-dose tenecteplase, as soon as possible before transport to a PCI center. In the pPCI arm, patients will be treated according to optimal standard of care defined by local practice. The key criteria for efficacy will be the number of patients achieving ≥50% ST-segment resolution before and after PCI in lead with maximal ST elevation at baseline and the clinical endpoints of death, congestive heart failure, shock or re-infarction, rescue PCI and aborted myocardial infarction, both singularly and as a composite at 30 days. Key safety criteria are total stroke, ICH and major non-intracranial bleeds. Approximately 600 patients will be randomized (400 to pharmaco-invasive treatment and 200 to pPCI). An interim analysis is planned after 300 patients are enrolled to consider adapting the trial to include a larger sample size aimed at undertaking a formal confirmatory trial.
DISCUSSION


The study will provide new insights aimed at establishing an effective and safer pharmaco-invasive treatment for the growing population of older STEMI patients who cannot undergo timely pPCI.",2020,The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase.,"['older STEMI patients who cannot undergo timely pPCI', '300 patients', 'older ST-elevation myocardial infarction patients', 'Approximately 600 patients', 'STEMI patients ≥60 years presenting within 3 hours from symptom onset', 'patients presenting early with ST-elevation myocardial infarction (STEMI']",['novel pharmaco-invasive strategy'],"['intracranial hemorrhage (ICH', 'bleeding events', 'efficacy and safety']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",600.0,0.0767294,The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase.,"[{'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Bogaerts', 'Affiliation': 'Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat), KU Leuven, Leuven and University Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Welsh', 'Affiliation': 'The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Sinnaeve', 'Affiliation': 'Dept. of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Goldstein', 'Affiliation': 'Emergency Department and SAMU, Lille University Hospital, Lille, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Pages', 'Affiliation': 'Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Danays', 'Affiliation': 'TDC, Aix en Provence, France.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Van de Werf', 'Affiliation': 'Dept. of Cardiovascular Sciences, KU Leuven, Leuven, Belgium. Electronic address: frans.vandewerf@kuleuven.be.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.029']
1281,32554365,Comparison of efficacy between combined periarticular and incisional injections versus periarticular injection alone of bupivacaine for pain control after total knee arthroplasty: A prospective randomized controlled trial.,"OBJECTIVE


The aim of this study was to compare the efficacy of combined periarticular and incisional injections versus periarticular injection alone of bupivacaine in reducing post-operative pain after total knee arthroplasty (TKA).
METHODS


In this prospective, randomized, double-blind comparative study, 90 patients with primary osteoarthritis who underwent TKA were enrolled. The patients were then randomly divided into 3 groups (30 in each): group 1, without injection; group 2, with periarticular injection of 20 mL 0.5% bupivacaine hydrogen chloride (HCl) (100 mg) after implantation; and group 3, periarticular injection of 20 mL 0.5% bupivacaine HCl (100 mg) after implantation and incisional injection of 10 mL 0.5% bupivacaine HCl (50 mg) before wound closure. Post-operative pain levels were measured using a 100-mm visual analogue scale (VAS) (0 mm: no pain and 100 mm: worst pain) at 30 min and 1, 2, 4, and 6 h, post-operatively.
RESULTS


The mean VAS score in group 3 (the combined group-periarticular and incisional injections) within the first 4 h was lower than that in group 1 and group 2 (p<0.001). The mean VAS scores at the first 30 min were 65.21±9.46 in group 1, 51.86±5.96 in group 2, and 29.33±8.55 in group 3 (p<0.001). The mean VAS scores at the first 1 h were 64.43±9.32 in group 1, 47.26±4.77 in group 2, and 31.66±7.37 in group 3 (p<0.001). The mean scores at the 2 h were 61.46±8.62 in group 1, 48.33±4.66 in group 2, and 30.83±6.76 in group 3 (p<0.001). The mean scores at the 4 h were 64.72±8.91 in group 1, 47.53±4.35 in group 2, and 34.36±6.64 in group 3 (p<0.001). The differences were not significant at 6 h between group 2 (44.91±4.12) and group 3 (41.83±6.71) (p>0.001). However, the values were significantly lower than those of the control group (63.56±9.73) (p<0.001). In addition, VAS scores at all follow-up times were significantly higher in the control group compared with the other groups (p<0.001).
CONCLUSION


Evidence from this study revealed that the combined injection of bupivacaine is more effective than its periarticular injection alone and provides effective post-operative pain management after TKA.
LEVEL OF EVIDENCE


Level I, Therapeutic study.",2020,"In addition, VAS scores at all follow-up times were significantly higher in the control group compared with the other groups (p<0.001).
","['90 patients with primary osteoarthritis who underwent TKA were enrolled', 'pain control after total knee arthroplasty', 'after total knee arthroplasty (TKA']","['combined periarticular and incisional injections versus periarticular injection alone of bupivacaine', 'periarticular injection of 20 mL 0.5% bupivacaine hydrogen chloride (HCl) (100 mg) after implantation; and group 3, periarticular injection of 20 mL 0.5% bupivacaine HCl (100 mg) after implantation and incisional injection of 10 mL 0.5% bupivacaine HCl', 'bupivacaine']","['mean scores', '100-mm visual analogue scale (VAS', 'Post-operative pain levels', 'mean VAS scores', 'post-operative pain', 'mean VAS score', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409952', 'cui_str': 'Idiopathic osteoarthritis'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0020259', 'cui_str': 'Hydrochloric Acid'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",90.0,0.0690695,"In addition, VAS scores at all follow-up times were significantly higher in the control group compared with the other groups (p<0.001).
","[{'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Altay', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Harran University, School of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Baran', 'Initials': 'B', 'LastName': 'Sarıkaya', 'Affiliation': 'Department of Orthopedics and Traumatology, Harran University, School of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Mahmut Alp', 'Initials': 'MA', 'LastName': 'Karahan', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Harran University, School of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Evren', 'Initials': 'E', 'LastName': 'Büyükfırat', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Harran University, School of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Binici', 'Affiliation': 'Department of Anaesthesiology and Reanimation, Harran University, School of Medicine, Şanlıurfa, Turkey.'}, {'ForeName': 'Cemil', 'Initials': 'C', 'LastName': 'Ertürk', 'Affiliation': 'Deparment of Orthopedics and Traumatology, Health Sciences University Kanuni Sultan Süleyman Training and Research Hospital, İstanbul, Turkey.'}, {'ForeName': 'Mehmet Akif', 'Initials': 'MA', 'LastName': 'Altay', 'Affiliation': 'Department of Orthopedics and Traumatology, Harran University, School of Medicine, Şanlıurfa, Turkey.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.20212']
1282,32554724,Feasibility randomised controlled trial of remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can): a study protocol.,"INTRODUCTION


Technology is emerging as a solution to develop home-based, proactive 'real-time' symptom monitoring and management in cancer care. The Advanced Symptom Monitoring and Management System-Canada (ASyMS-Can) is a remote phone-based symptom management system that enables real-time remote monitoring of systemic chemotherapy toxicities.
METHODS AND ANALYSIS


This study is an open-label, prospective, mixed-method, Phase II, 2-arm parallel group assignment (ASyMS-Can vs usual care) feasibility study in patients with cancer receiving systemic (neo-adjuvant or adjuvant) chemotherapy at Princess Margaret Cancer Centre. A total of 114 patients will be recruited in oncology clinics prior to initiation of chemotherapy. Patients in both arms will complete a demographic and a set of questionnaires at enrolment, mid and end of treatment. Patients in intervention arm will be provided with an encrypted, secure, preprogrammed ASyMS phone for symptom reporting daily for the first 14 days of each chemotherapy treatment cycle up to sixth cycle (16 weeks). Feasibility metrics (recruitment, retention and protocol adherence) and outcomes to assess impact of ASyMS-Can include symptom severity, emotional distress, quality of life and acceptability to patients and clinicians.
ETHICS AND DISSEMINATION


The study has received ethical and institutional approvals from the University Health Network. Dissemination will include presentations at national/international conferences, and publications in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03335189.",2020,"The Advanced Symptom Monitoring and Management System-Canada (ASyMS-Can) is a remote phone-based symptom management system that enables real-time remote monitoring of systemic chemotherapy toxicities.
","['114 patients will be recruited in oncology clinics prior to initiation of chemotherapy', 'patients with cancer receiving systemic (neo-adjuvant or adjuvant) chemotherapy at Princess Margaret Cancer Centre']",['remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can'],"['symptom severity, emotional distress, quality of life and acceptability', 'Feasibility metrics (recruitment, retention and protocol adherence']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3839015', 'cui_str': 'Oncology clinic'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",114.0,0.0743316,"The Advanced Symptom Monitoring and Management System-Canada (ASyMS-Can) is a remote phone-based symptom management system that enables real-time remote monitoring of systemic chemotherapy toxicities.
","[{'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Moradian', 'Affiliation': 'School of Nursing, York University Faculty of Health, Toronto, Ontario, Canada.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Krzyzanowska', 'Affiliation': 'University of Toronto Institute of Health Policy Management and Evaluation, Toronto, Ontario, Canada.'}, {'ForeName': 'Roma', 'Initials': 'R', 'LastName': 'Maguire', 'Affiliation': 'University of Strathclyde Department of Computer and Information Sciences, Glasgow, UK.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Kukreti', 'Affiliation': 'Division of Medical Oncology and Hematology, University of Toronto Faculty of Medicine, Toronto, Ontario, Canada.'}, {'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Amir', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Plinio P', 'Initials': 'PP', 'LastName': 'Morita', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, Waterloo, ON, Canada.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'University Health Network and Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Howell', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada doris.howell@uhn.ca.'}]",BMJ open,['10.1136/bmjopen-2019-035648']
1283,32554725,Electronic symptom monitoring in patients with metastatic lung cancer: a feasibility study.,"OBJECTIVES


To design an electronic questionnaire for symptom monitoring and to evaluate the feasibility, usability and acceptability when applied to patients with metastatic lung cancer.
SETTING


Single-centre feasibility study.
PARTICIPANTS


Patients with stage IV lung cancer in antineoplastic treatment.
INTERVENTIONS


This study describes the first three phases of a complex intervention design: phase 1, development of the intervention; phase 2, feasibility testing and phase 3, evaluation of the intervention. In phase 1, items were selected for the questionnaire and adjusted following patient interviews. In phase 2, patients completed the electronic questionnaire weekly during a 3-week feasibility test. In case of symptom deterioration, a nurse was notified with the aim to contact the patient. In phase 3, patients evaluated phase 2 by paper questionnaires, and interviews were conducted with the participating nurses.
PRIMARY OUTCOME MEASURES


The study outcomes: phase 1, usability and relevance; phase 2, recruitment rate, compliance and threshold functionality and phase 3, usability, acceptability and relevance.
RESULTS


In phase 1, a questionnaire was designed and reviewed by patients (n=8). The interviews revealed high usability and relevance of the intervention.For phases 2 and 3, 20 of 29 approached patients (69%) responded to the questionnaire on a weekly basis. Two patients did not complete any questionnaires (compliance 90%). The remaining 18 patients completed 65 of a total of 72 possible questionnaires (7 missed, 93% completed). Reported symptoms led to a phone call from a nurse in 30% of the responses.The patients reported high usability and acceptability of questionnaire and software. The substance of the telephonic conversations was relevant, and the study set-up was logistically acceptable.
CONCLUSIONS


An electronic questionnaire designed for symptom monitoring revealed high usability, acceptability and relevance in the target population. In conclusion, the study set-up was considered feasible for a randomised controlled trial.
TRIAL REGISTRATION NUMBER


NCT03529851.",2020,"For phases 2 and 3, 20 of 29 approached patients (69%) responded to the questionnaire on a weekly basis.","['patients with metastatic lung cancer', 'Patients with stage IV lung cancer in antineoplastic treatment', '18 patients completed 65 of a total of 72 possible questionnaires (7 missed, 93% completed']",['Electronic symptom monitoring'],"['usability and relevance; phase 2, recruitment rate, compliance and threshold functionality and phase 3, usability, acceptability and relevance', 'feasibility, usability and acceptability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0855005', 'cui_str': 'Lung carcinoma cell type unspecified stage IV'}, {'cui': 'C0003392', 'cui_str': 'Antineoplastic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",29.0,0.0401048,"For phases 2 and 3, 20 of 29 approached patients (69%) responded to the questionnaire on a weekly basis.","[{'ForeName': 'Rasmus Blechingberg', 'Initials': 'RB', 'LastName': 'Friis', 'Affiliation': 'Department of Oncology, Hospital Unit West Jutland, Herning, Denmark rasfri@rm.dk.'}, {'ForeName': 'Niels Henrik', 'Initials': 'NH', 'LastName': 'Hjollund', 'Affiliation': 'AmbuFlex, Occupational Medicine, University Research Clinic, Aarhus University, Hospital Unit West Jutland, Herning, Denmark.'}, {'ForeName': 'Caroline Trillingsgaard', 'Initials': 'CT', 'LastName': 'Mejdahl', 'Affiliation': 'AmbuFlex, Occupational Medicine, University Research Clinic, Aarhus University, Hospital Unit West Jutland, Herning, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Pappot', 'Affiliation': 'Department of Oncology, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Halla', 'Initials': 'H', 'LastName': 'Skuladottir', 'Affiliation': 'Department of Oncology, Hospital Unit West Jutland, Herning, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-035673']
1284,32559601,Cardiovascular responses to pelvic floor muscle contraction in healthy women: Prospective study.,"OBJECTIVE


Analyze the acute heart rate and blood pressure responses to two protocols of pelvic floor muscles contractions in premenopausal and postmenopausal women.
METHODS


Fifty-four women without pelvic floor muscles disorders were eligible and allocated into two groups: premenopausal and postmenopausal. The groups underwent two protocols and the pelvic floor muscle endurance, heart rate, and blood pressure values were monitored. Both protocols included 10 pelvic floor muscles contractions; one series contained contractions lasting 5 s with 5 s of rest between each contraction and the other series contained contractions lasting 10 s with 10 s of rest.
RESULTS


In both groups, there was a significant increase in the heart rate during pelvic floor muscles contractions (premenopausal: 71.0 ± 7.3 and 80.3 ± 7.7; postmenopausal: 65.4 ± 6.6 and 73.6 ± 6.6, at rest and contractions peak, respectively) and in systolic blood pressure immediately after the contractions. The observed values during exercise returned to basal values seconds after the contractions. A positive correlation between heart rate and vaginal squeeze pressure (r = 0.45, p = 0.0007 and r = 0.48, p = 0.0003, 5- and 10-s series, respectively) was observed.
CONCLUSION


The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.",2020,The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.,"['premenopausal and postmenopausal women', 'healthy women', 'healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions', 'Fifty-four women without pelvic floor muscles disorders were eligible and allocated into two groups: premenopausal and postmenopausal']",['pelvic floor muscles contractions'],"['heart rate and blood pressure', 'pelvic floor muscle endurance, heart rate, and blood pressure values', 'heart rate', 'Cardiovascular responses', 'systolic blood pressure', 'heart rate and vaginal squeeze pressure']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",54.0,0.0281104,The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.,"[{'ForeName': 'Alana Maria G', 'Initials': 'AMG', 'LastName': 'Bastos', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Aparecida M', 'Initials': 'AM', 'LastName': 'Catai', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Soraia P', 'Initials': 'SP', 'LastName': 'Jürgensen', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Grasiela N', 'Initials': 'GN', 'LastName': 'Correia', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Vanessa S', 'Initials': 'VS', 'LastName': 'Pereira-Baldon', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Perseguini', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Driusso', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil. Electronic address: pdriusso@ufscar.br.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.050']
1285,32560911,"Effect of mental rotation skills training on ultrasound-guided regional anaesthesia task performance by novice operators: a rater-blinded, randomised, controlled study.","BACKGROUND


The effect of mental rotation training on ultrasound-guided regional anaesthesia (UGRA) skill acquisition is currently unknown. In this study we aimed to examine whether mental rotation skill training can improve UGRA task performance by novice operators.
METHODS


We enrolled 94 volunteers with no prior experience of UGRA in this randomised controlled study. After a baseline mental rotation test, their performance in a standardised UGRA needling task was independently assessed by two raters using the composite error score (CES) and global rating scale (GRS). Volunteers with low baseline mental rotation ability were randomised to a mental rotation training group or a no training group, and the UGRA needling task was repeated to determine the impact of the training intervention on task performance. The study primary outcome measure was UGRA needling task CES measured before and after the training intervention.
RESULTS


Multivariate analyses controlling for age, gender, and previous performance showed that participants exposed to the training intervention made significantly fewer errors (CES B=-0.66 [standard error, se=0.17]; P<0.001; 95% confidence interval [CI], -0.92 to -0.26) and displayed improved overall performance (GRS B=6.15 [se=2.99], P=0.048, 95% CI=0.06 to 12.13) when undertaking the UGRA needling task.
CONCLUSIONS


A simple training intervention, based on the manipulation and rotation of three-dimensional models, results in improved technical performance of a UGRA needling task in operators with low baseline mental rotation skills.",2020,"A simple training intervention, based on the manipulation and rotation of three-dimensional models, results in improved technical performance of a UGRA needling task in operators with low baseline mental rotation skills.","['94 volunteers with no prior experience of UGRA', 'in operators with low baseline mental rotation skills', 'Volunteers with low baseline mental rotation ability', 'ultrasound-guided regional anaesthesia task performance by novice operators']","['UGRA needling task', 'mental rotation training group or a no training group, and the UGRA needling task', 'mental rotation skills training', 'mental rotation training', 'mental rotation skill training']","['UGRA task performance', 'composite error score (CES) and global rating scale (GRS', 'UGRA needling task CES', 'overall performance']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",94.0,0.202241,"A simple training intervention, based on the manipulation and rotation of three-dimensional models, results in improved technical performance of a UGRA needling task in operators with low baseline mental rotation skills.","[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hewson', 'Affiliation': 'Department of Anaesthesia, Nottingham University Hospitals NHS Trust, Nottingham, UK. Electronic address: david.hewson@nottingham.ac.uk.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Knudsen', 'Affiliation': 'Department of Anaesthesia, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Sanjeevan', 'Initials': 'S', 'LastName': 'Shanmuganathan', 'Affiliation': 'Department of Anaesthesia, Royal National Orthopaedic Hospital, Stanmore, UK.'}, {'ForeName': 'Eamonn', 'Initials': 'E', 'LastName': 'Ferguson', 'Affiliation': 'Personality, Social Psychology and Health Research Group, School of Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Hardman', 'Affiliation': 'Department of Anaesthesia, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Nigel M', 'Initials': 'NM', 'LastName': 'Bedforth', 'Affiliation': 'Department of Anaesthesia, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Rob A', 'Initials': 'RA', 'LastName': 'McCahon', 'Affiliation': 'Department of Anaesthesia, Nottingham University Hospitals NHS Trust, Nottingham, UK.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.04.090']
1286,32561426,Recombinant human thrombopoietin in critically ill patients with sepsis-associated thrombocytopenia: A clinical study.,"BACKGROUND


Sepsis causes varying degrees of thrombocytopenia that are closely related to the likelihood of patient mortality. This study analysed the effect of recombinant human thrombopoietin (rhTPO) on the platelet count in critically ill patients with sepsis-associated thrombocytopenia and provided a reference for its treatment.
MATERIAL/METHODS


The study was a retrospective analysis of the clinical data of patients. Patients were divided into an rhTPO group and control group according to rhTPO use during treatment. Demographical and clinical data (age, sex, history of hypertension, diabetes, platelet counts, mortality rate, etc.) of the patients were collected and analysed using statistical software; p < 0.05 was considered statistically significant.
RESULTS


Of 213 patients, 84 constituted the rhTPO group and 129 constituted the control group. The increase in platelet counts was significantly higher in the rhTPO group than in the control group on the third day (43.01 ± 18.23 × 10 9 /L vs. 36.31 ± 14.17 × 10 9 /L, p = 0.003), fifth day (71.51 ± 39.59 × 10 9 /L vs. 42.95 ± 20.48 × 10 9 /L, p < 0.001) and seventh day (115.36 ± 69.41 × 10 9 /L vs. 62.54 ± 42.70 × 10 9 /L, p < 0.001). Further statistical analysis of the data of patients with platelet counts ≤30 × 10 9 /L and >30 × 10 9 /L and APACHE II scores >15 and ≤15 at the time of diagnosis showed that the increase in platelet counts in the rhTPO group was greater. There was no significant between-group difference in volume of platelet transfusions (rhTPO group 15.42 ± 17.20 vs. control group 10.93 ± 17.48, p = 0.068). The cost of ICU treatment in patients with rhTPO was higher (RMB 126,936.21 ± 86,548.27 vs. 101,685.28 ± 77,291.75, p = 0.027); however, the ICU stay time was shorter (9.20 ± 5.38 vs. 10.88 ± 6.82, p = 0.047). There was no significant difference in 28-day mortality (rhTPO group: 25.0% vs. control group: 34.1%, p = 0.158) between the two groups.
CONCLUSION


For patients with severe thrombocytopenia or severe sepsis, rhTPO was efficacious in increasing their platelet counts, resulting in a shorter ICU stay time.",2020,The increase in platelet counts was significantly higher in the rhTPO group than in the control group on the third day (43.01±18.23×10 9,"['patients with severe thrombocytopenia or patients with severe sepsis', 'patients with platelet counts', 'critically ill patients with sepsis-associated thrombocytopenia and provided a reference for its treatment', '213 patients', '84 patients constituted the rhTPO group and 129 constituted the control group', 'critically ill patients with sepsis-associated thrombocytopenia', '≤30×10 9']","['recombinant human thrombopoietin (rhTPO', 'Recombinant human thrombopoietin', 'rhTPO']","['ICU stay time', 'platelet counts', 'volume of platelet transfusions', 'cost of ICU treatment', '28-days mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0040052', 'cui_str': 'Thrombopoietin'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0086818', 'cui_str': 'Platelet transfusion'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",213.0,0.0258731,The increase in platelet counts was significantly higher in the rhTPO group than in the control group on the third day (43.01±18.23×10 9,"[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Jin', 'Affiliation': ""Emergency Department, Xi'an Aerospace General Hospital, Xi'an, China.""}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. Electronic address: wangxuejd2008@126.com.""}, {'ForeName': 'Litao', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': ""Department of Critical Care Medicine, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China. Electronic address: glt2002@xjtu.edu.cn.""}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.06.045']
1287,32561466,A randomized clinical trial of a collaborative home-based diabetes intervention to reduce emergency department visits and hospitalizations in black individuals with diabetes.,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system. These three factors account for higher rates of acute medical care use in blacks with DM. To address this disparity, we developed DM I-TEAM (Diabetes Interprofessional Team to Enhance Adherence to Medical Care), a home-based multidisciplinary behavioral intervention that integrates care from a community health worker (CHW), the participant's primary care physician (PCP), a DM nurse educator, and a clinical pharmacist. Treatment is delivered during 9 sessions over 1 year, and includes diabetes education and goal setting, telehealth visits with participants' PCP and a DM nurse educator, and comprehensive medication reviews by a pharmacist. We describe the rationale and methods for a randomized controlled trial to test the efficacy of DM I-TEAM to reduce emergency department (ED) visits and hospitalizations. We are enrolling 200 blacks with DM during an ED visit. Participants are randomized to DM I-TEAM or Usual Medical Care (UMC). Follow-up assessments are conducted at 6 and 12 months. The primary outcome is the number of ED visits and hospitalizations over 12 months, and is measured by participant self-report and medical record review. Secondary outcomes include hemoglobin A1c (HbA1c), number of potentially inappropriate medications (PIMs), and trust in health care.",2020,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system.","['200 blacks with DM during an ED visit', 'blacks with DM', 'black individuals (blacks', 'black individuals with diabetes']","['DM I-TEAM', 'collaborative home-based diabetes intervention', 'DM I-TEAM or Usual Medical Care (UMC']","['hemoglobin A1c (HbA1c), number of potentially inappropriate medications (PIMs), and trust in health care', 'emergency department (ED) visits and hospitalizations', 'prevalence of diabetes mellitus (DM', 'number of ED visits and hospitalizations over 12\u202fmonths, and is measured by participant self-report and medical record review']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0730229', 'cui_str': 'Medical records review'}]",200.0,0.0803291,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system.","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Casten', 'Affiliation': 'Department of Psychiatry and Human Behavior, Sidney Kimmel Medical College at Thomas, Jefferson University, United States of America. Electronic address: Robin.Casten@Jefferson.edu.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Rovner', 'Affiliation': 'Departments of Neurology, Psychiatry, and Ophthalmology, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Anna Marie', 'Initials': 'AM', 'LastName': 'Chang', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Judd E', 'Initials': 'JE', 'LastName': 'Hollander', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Kelley', 'Affiliation': 'Department of Neurology, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Leiby', 'Affiliation': 'Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Ginah', 'Initials': 'G', 'LastName': 'Nightingale', 'Affiliation': 'Jefferson College of Pharmacy at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pizzi', 'Affiliation': 'Center for Health Outcomes, Policy, and Economics, Ernest Mario School of Pharmacy, Rutgers University, United States of America.'}, {'ForeName': 'Neva', 'Initials': 'N', 'LastName': 'White', 'Affiliation': 'Center for Urban Health, Thomas Jefferson University Hospital, United States of America.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rising', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106069']
1288,32561467,A randomized comparison trial of culturally adapted HIV prevention approaches for Native Americans reducing trauma symptoms versus substance misuse: The Healing Seasons protocol.,"Native Americans (NA) experience interrelated risks of trauma exposure, substance use, and HIV risk behaviors that put them at increased risk for HIV infection. Despite these known risk factors, there are very few published randomized trials testing interventions to reduce trauma-related symptoms and substance misuse among NA.
METHODS


The Healing Seasons study is a randomized comparsion trial of two counseling strategies, Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST) addressing substance misuse as a means to prevent HIV among NA. Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies. Participants, 16 years and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person, and randomized in equal numbers to NET or MIST. We stratified by age (16-29 years and 30 or older) and gender (male or female identified) to ensure balance between treatment arms. The primary outcomes were number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity.
DISCUSSION


Behavioral interventions for NA are needed to prevent HIV risk behaviors when faced with trauma symptoms and substance misuse. This study will provide evidence to determine feasibility and efficacy of addressing related risk factors as part of counseling-based HIV prevention intervention to reduce sexual risk among this population.
TRIAL REGISTRATION


ClinicalTrials.gov number, NCT03112369, registered April 12, 2017.",2020,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","['Native Americans reducing trauma symptoms versus substance misuse', 'We stratified by age (16-29\u202fyears and 30 or older) and gender (male or female identified', 'Participants, 16\u202fyears and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person']","['NET or MIST', 'culturally adapted HIV prevention approaches', 'Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST', 'counseling-based HIV prevention intervention']","['number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity', 'HIV risk behaviors']","[{'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030170', 'cui_str': 'Pacific Northwest'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0757073,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Pearson', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA. Electronic address: pearsonc@uw.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kaysen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Huh', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bedard-Gillgan', 'Affiliation': 'Department of Psychiatry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Innovative Programs Research Group, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marin', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Saluskin', 'Affiliation': 'Yakama Nation Behavioral Health Services, Toppenish, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106070']
1289,32553996,"The effects of a nurse-led lifestyle intervention program on cardiovascular risk, self-efficacy and health promoting behaviours among patients with metabolic syndrome: Randomized controlled trial.","BACKGROUND


Metabolic syndrome is a cluster of cardio-metabolic risk factors and a major burden for public health due to its increasing prevalence and adverse effects on cardiovascular health. Lifestyle modification is the first-line intervention for metabolic syndrome management. However, adopting healthy behaviours is challenging among patients with metabolic syndrome.
OBJECTIVE


To examine the effects of a nurse-led lifestyle intervention program on cardiovascular risks, self-efficacy and the implementation of health promoting behaviours.
DESIGN


A two-armed randomized controlled trial.
SETTINGS AND PARTICIPANTS


A total of 173 patients that satisfied the metabolic syndrome definition of International Diabetes Federation was recruited from a hospital in North China.
METHODS


The participants were randomly assigned to either attend the lifestyle interventions (n = 86) or receive usual care from the study hospital (n = 87). The lifestyle intervention followed the framework of Health Promotion Model and consisted of one face-to-face education session (30-40 min), one educational booklet and six telephone follow-ups (bi-weekly, 20-30 min per call) in three months. The Framingham 10-year risk score was calculated to measure the participants' cardiovascular risks at baseline and 3-month. The Self-rated Abilities for Health Practices and Health Promoting Lifestyle Profile II was employed to measure the self-efficacy and health promoting behaviours at baseline, 1-month, and 3-month. The generalized estimating equation model was employed to examine the effects of the lifestyle intervention program.
RESULTS


No difference was detected in the baseline characteristics between the two groups. Decreased cardiovascular risk was found in the lifestyle intervention group, but no significant group-by-time effect was detected. The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05). Significant improvements were also detected in all subscales, total scale of self-efficacy, all dimensions and the sum score of health promoting behaviours at 3-month (all p < 0.05).
CONCLUSIONS


The nurse-led Health Promotion Model guided lifestyle intervention program effectively improved the self-efficacy and implementation of health promoting behaviours in patients with metabolic syndrome. We recommend that nurses apply lifestyle interventions in routine care for patients with metabolic syndrome. Tweetable abstract: The RCT revealed that nurse-led lifestyle intervention was effective to improve self-efficacy and healthy behaviours among 173 MetS patients.",2020,"The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05).","['173 patients that satisfied the metabolic syndrome definition of International Diabetes Federation was recruited from a hospital in North China', 'patients with metabolic syndrome', '173 MetS patients']","['nurses apply lifestyle interventions', 'nurse-led lifestyle intervention program', 'lifestyle intervention followed the framework of Health Promotion Model and consisted of one face-to-face education session (30-40\xa0min), one educational booklet and six telephone follow-ups', 'lifestyle interventions (n\xa0=\xa086) or receive usual care from the study hospital', 'Tweetable abstract']","['cardiovascular risks, self-efficacy', 'cardiovascular risk', 'cardiovascular risk, self-efficacy and health promoting behaviours', 'subscales, total scale of self-efficacy, all dimensions and the sum score of health promoting behaviours', 'self-efficacy and healthy behaviours', 'Framingham 10-year risk score', 'self-efficacy and implementation of health promoting behaviours', 'self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",173.0,0.0272669,"The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05).","[{'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: zhengxujuan@szu.edu.cn.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Endocrinology, Pingdu People's Hospital, Qingdao, China. Electronic address: yuhongbo.doc@163.com.""}, {'ForeName': 'Xichenhui', 'Initials': 'X', 'LastName': 'Qiu', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: qiuxichenhui@163.com.'}, {'ForeName': 'Sek Ying', 'Initials': 'SY', 'LastName': 'Chair', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong. Electronic address: sychair@cuhk.edu.hk.'}, {'ForeName': 'Eliza Mi-Ling', 'Initials': 'EM', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University. Hung Hom, Kowloon, Hong Kong. Electronic address: eliza.wong@polyu.edu.hk.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: qunwang@szu.edu.cn.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103638']
1290,32554025,swCRTdesign: An R Package for Stepped Wedge Trial Design and Analysis.,"BACKGROUND AND OBJECTIVE


Stepped wedge trials (SWTs) are a type of cluster-randomized trial that are commonly used to evaluate health care interventions. Most SWT-related software packages have restrictive assumptions about the study design and correlation structure of the data. The objective of this paper is to present a package and corresponding web-based graphical user interface (GUI) that provide researchers with another, more flexible option for SWT design and analysis.
METHODS


We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design. Possible sources of correlation include clusters, time within clusters, and treatment within clusters.
RESULTS


swCRTdesign allows a user to calculate power, simulate SWT data to streamline simulation studies (e.g. to estimate power), and create descriptive summaries and plots. Additionally, a GUI, developed using shiny, is available to calculate power and create power curves and design plots.
CONCLUSIONS


The swCRTdesign package accommodates a wide variety of SWT designs, and makes it easy to account for some sources of correlation which are not found in other packages. The user-friendly web-based GUI makes some swCRTdesign features accessible to researchers not familiar with R. These two resources will make appropriately complex SWT calculations more accessible to scientists from a wide variety of backgrounds.",2020,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.",[],['swCRTdesign'],[],[],[],[],,0.150645,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.","[{'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Voldal', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States. Electronic address: voldal@uw.edu.'}, {'ForeName': 'Navneet R', 'Initials': 'NR', 'LastName': 'Hakhu', 'Affiliation': 'Department of Statistics, University of California, Irvine, Irvine, CA 92697, United States.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105514']
1291,32555624,The consequences of exercise-induced weight loss on food reinforcement. A randomized controlled trial.,"BACKGROUND


Obesity remains a primary threat to the health of most Americans, with over 66% considered overweight or obese with a body mass index (BMI) of 25 kg/m2 or greater. A common treatment option many believe to be effective, and therefore turn to, is exercise. However, the amount of weight loss from exercise training is often disappointingly less than expected with greater amounts of exercise not always promoting greater weight loss. Increases in energy intake have been prescribed as the primary reason for this lack of weight loss success with exercise. Research has mostly focused on alterations in hormonal mediators of appetite (e.g.: ghrelin, peptide YY, GLP-1, pancreatic polypeptide, and leptin) that may increase hunger and/or reduce satiety to promote greater energy intake with exercise training. A less understood mechanism that may be working to increase energy intake with exercise is reward-driven feeding, a strong predictor of energy intake and weight status but rarely analyzed in the context of exercise.
DESIGN


Sedentary men and women (BMI: 25-35 kg/m2, N = 52) were randomized into parallel aerobic exercise training groups partaking in either two or six exercise sessions/week, or sedentary control for 12 weeks.
METHODS


The reinforcing value of food was measured by an operant responding progressive ratio schedule task (the behavioral choice task) to determine how much work participants were willing to perform for access to a healthy food option relative to a less healthy food option before and after the exercise intervention. Body composition and resting energy expenditure were assessed via DXA and indirect calorimetry, respectively, at baseline and post testing.
RESULTS


Changes in fat-free mass predicted the change in total amount of operant responding for food (healthy and unhealthy). There were no correlations between changes in the reinforcing value of one type of food (healthy vs unhealthy) to changes in body composition.
CONCLUSION


In support of previous work, reductions in fat-free mass resulting from an aerobic exercise intervention aimed at weight loss plays an important role in energy balance regulation by increasing operant responding for food.",2020,"There were no correlations between changes in the reinforcing value of one type of food (healthy vs unhealthy) to changes in body composition.
","['health of most Americans, with over 66% considered overweight or obese with a body mass index (BMI) of 25 kg/m2 or greater', 'BMI', 'N = 52', 'Sedentary men and women']","['aerobic exercise intervention', 'parallel aerobic exercise training groups partaking in either two or six exercise sessions/week, or sedentary control for 12 weeks']","['Body composition and resting energy expenditure', 'weight loss', 'total amount of operant responding for food (healthy and unhealthy']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",52.0,0.0679676,"There were no correlations between changes in the reinforcing value of one type of food (healthy vs unhealthy) to changes in body composition.
","[{'ForeName': 'Kyle D', 'Initials': 'KD', 'LastName': 'Flack', 'Affiliation': 'Department of Dietetics and Human Nutrition, University of Kentucky, Lexington, Kentucky, United States of America.'}, {'ForeName': 'Harry M', 'Initials': 'HM', 'LastName': 'Hays', 'Affiliation': 'Department of Dietetics and Human Nutrition, University of Kentucky, Lexington, Kentucky, United States of America.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Moreland', 'Affiliation': 'Department of Dietetics and Human Nutrition, University of Kentucky, Lexington, Kentucky, United States of America.'}]",PloS one,['10.1371/journal.pone.0234692']
1292,32555695,"Prognostic factors for changes in the timed 4-stair climb in patients with Duchenne muscular dystrophy, and implications for measuring drug efficacy: A multi-institutional collaboration.","The timed 4-stair climb (4SC) assessment has been used to measure function in Duchenne muscular dystrophy (DMD) practice and research. We sought to identify prognostic factors for changes in 4SC, assess their consistency across data sources, and the extent to which prognostic scores could be useful in DMD clinical trial design and analysis. Data from patients with DMD in the placebo arm of a phase 3 trial (Tadalafil DMD trial) and two real-world sources (Universitaire Ziekenhuizen, Leuven, Belgium [Leuven] and Cincinnati Children's Hospital Medical Center [CCHMC]) were analyzed. One-year changes in 4SC completion time and velocity (stairs/second) were analyzed. Prognostic models included age, height, weight, steroid use, and multiple timed function tests and were developed using multivariable regression, separately in each data source. Simulations were used to quantify impacts on trial sample size requirements. Data on 1-year changes in 4SC were available from the Tadalafil DMD trial (n = 92) Leuven (n = 67), and CCHMC (n = 212). Models incorporating multiple timed function tests, height, and weight significantly improved prognostic accuracy for 1-year change in 4SC (R2: 29%-36% for 4SC velocity, and 29%-34% for 4SC time) compared to models including only age, baseline 4SC and steroid duration (R2:8%-17% for 4SC velocity and 2%-13% for 4SC time). Measures of walking and rising ability contributed important prognostic information for changes in 4SC. In a randomized trial with equal allocation to treatment and placebo, adjustment for such a prognostic score would enable detection (at 80% power) of a treatment effect of 0.25 stairs/second with 100-120 patients, compared to 170-190 patients without prognostic score adjustment. Combining measures of ambulatory function doubled prognostic accuracy for 1-year changes in 4SC completion time and velocity. Randomized clinical trials incorporating a validated prognostic score could reduce sample size requirements by approximately 40%. Knowledge of important prognostic factors can also inform adjusted comparisons to external controls.",2020,"Models incorporating multiple timed function tests, height, and weight significantly improved prognostic accuracy for 1-year change in 4SC (R2: 29%-36% for 4SC velocity, and 29%-34% for 4SC time) compared to models including only age, baseline 4SC and steroid duration (R2:8%-17% for 4SC velocity and 2%-13% for 4SC time).","['patients with Duchenne muscular dystrophy', 'patients with DMD in the']",['placebo'],"['sample size requirements', '4SC completion time and velocity (stairs/second']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",212.0,0.0551207,"Models incorporating multiple timed function tests, height, and weight significantly improved prognostic accuracy for 1-year change in 4SC (R2: 29%-36% for 4SC velocity, and 29%-34% for 4SC time) compared to models including only age, baseline 4SC and steroid duration (R2:8%-17% for 4SC velocity and 2%-13% for 4SC time).","[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Goemans', 'Affiliation': 'Department of Child Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Wong', 'Affiliation': 'Department of Pediatrics, University of Massachusetts Medical School, Worcester, MA, United States of America.'}, {'ForeName': 'Marleen', 'Initials': 'M', 'LastName': 'Van den Hauwe', 'Affiliation': 'Department of Child Neurology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Signorovitch', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Sajeev', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cox', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, United States of America.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Landry', 'Affiliation': 'Eli Lilly and Company, Toronto, Ontario, Canada.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Jenkins', 'Affiliation': 'Analysis Group Inc., London, United Kingdom.'}, {'ForeName': 'Ibrahima', 'Initials': 'I', 'LastName': 'Dieye', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'Zhiwen', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'Intekhab', 'Initials': 'I', 'LastName': 'Hossain', 'Affiliation': 'Analysis Group Inc., Boston, Massachusetts, United States of America.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Ward', 'Affiliation': 'The Collaborative Trajectory Analysis Project, Cambridge, Massachusetts, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0232870']
1293,32561468,Enhancing prolonged exposure therapy for PTSD among veterans with oxytocin: Design of a multisite randomized controlled trial.,"Posttraumatic stress disorder (PTSD) is the most highly prevalent mental health disorder among U.S. military Veterans. Prolonged Exposure (PE) therapy is one of the most widely used evidence-based treatments for PTSD, but there is substantial room for improvement in outcomes and retention rates. Accumulating data suggest that oxytocin offers a promising pharmacological approach towards achieving this goal. Therefore, the primary objective of this two-site Phase II study is to examine the ability of oxytocin (vs. placebo) administration combined with PE therapy to (1) reduce PTSD symptom severity, (2) accelerate the rate of PTSD symptom improvement, and (3) improve PE adherence and retention rates. To accomplish these objectives, we will employ a randomized, double-blind, placebo-controlled trial and use standardized, repeated dependent measures of change at five time points (baseline, mid-treatment, end of treatment, and 3 and 6 month follow-up). Intranasal oxytocin (40 IU) will be administered directly prior to each PE therapy session. Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response. ClinicalTrials.gov Identifier: NCT04228289.",2020,"Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response.","['Posttraumatic stress disorder (PTSD', 'PTSD among veterans with']","['Prolonged Exposure (PE) therapy', 'oxytocin', 'oxytocin (vs. placebo) administration combined with PE therapy', 'Intranasal oxytocin', 'placebo']","['PTSD symptom severity, (2) accelerate the rate of PTSD symptom improvement, and (3) improve PE adherence and retention rates']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.421747,"Findings from this study will provide critical new information regarding the efficacy of oxytocin to augment psychosocial treatment for PTSD, as well as information regarding the physiological mechanisms underlying PTSD and positive treatment response.","[{'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Mitchell', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; Department of Neurology, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: jennifer.mitchell@ucsf.edu.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: bakern@musc.edu.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Woolley', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: josh.woolley@ucsf.edu.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Wangelin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: bethany.wangelin@va.gov.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'McQuaid', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: john.mcquaid@va.gov.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Neylan', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; Department of Neurology, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: thomas.neylan@ucsf.edu.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Wolfe', 'Affiliation': 'Department of Psychiatry, University of California San Francisco, San Francisco, CA, USA; San Francisco Veterans Affairs Health Care System, San Francisco, CA, USA. Electronic address: william.wolfe@ucsf.edu.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: bradykt@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106074']
1294,32563171,Adjunctive perampanel and myoclonic and absence seizures: Post hoc analysis of data from study 332 in patients with idiopathic generalized epilepsy.,"PURPOSE


This post hoc analysis assessed the effects of adjunctive perampanel on myoclonic and absence seizure outcomes in patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332.
METHODS


Patients experiencing myoclonic and/or absence seizures during study baseline were included. Assessments for myoclonic and absence seizures included: median percent change in seizure frequency, number of seizure days and seizure-free days (all per 28 days), 50 % and 75 % responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs).
RESULTS


During the double-blind phase, myoclonic and/or absence seizures were reported in 47/163 and 60/163 patients, respectively. Median percent reductions in seizure frequency per 28 days from study baseline were 52.5% and 24.5% (myoclonic seizures) and 7.6 % and 41.2 % (absence seizures) for placebo and perampanel, respectively; seizure-freedom rates were 13.0 % and 16.7 % (myoclonic seizures) and 12.1 % and 22.2 % (absence seizures), respectively. During the OLEx phase, 46/138 and 52/138 patients experienced myoclonic and/or absence seizures, respectively. Responses during the double-blind phase were maintained during long-term (>104 weeks) adjunctive perampanel treatment. The frequency/type of TEAEs was consistent with the known safety profile of perampanel.
CONCLUSION


In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures. Further research is needed to investigate the effect of adjunctive perampanel in IGE patients with myoclonic and/or absence seizures.",2020,"In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures.","['and myoclonic and absence seizures', 'patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332', 'Patients experiencing myoclonic and/or absence seizures during study baseline were included', 'patients with idiopathic generalized epilepsy', 'IGE patients with myoclonic and/or absence seizures']","['Adjunctive perampanel', 'adjunctive perampanel', 'placebo']","['responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs', 'seizure frequency', 'overall worsening of absence seizures', 'myoclonic and/or absence seizures', 'seizure frequency, number of seizure days and seizure-free days', 'seizure-freedom rates', 'myoclonic and absence seizure outcomes']","[{'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270850', 'cui_str': 'Idiopathic generalized epilepsy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.383148,"In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Centre, Maraweg 21, 33617, Bielefeld, Germany. Electronic address: Christian.Brandt@mara.de.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Wechsler', 'Affiliation': 'Idaho Comprehensive Epilepsy Center, 1499 West Hays St., Boise, ID, 83702, USA. Electronic address: rtw@idahoepilepsy.com.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': ""O'Brien"", 'Affiliation': 'The Department of Neuroscience, The Central Clinical School, Monash University, The Alfred Centre, 99 Commercial Road, Melbourne, VIC, 3004, Australia; The Departments of Medicine, The Royal Melbourne Hospital, The University of Melbourne, Grattan St., Parkville, VIC, 3010, Australia. Electronic address: terence.obrien@monash.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Ltd., Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, UK. Electronic address: Anna_Patten@eisai.net.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA. Electronic address: Manoj_Malhotra@eisai.com.'}, {'ForeName': 'Leock Y', 'Initials': 'LY', 'LastName': 'Ngo', 'Affiliation': 'Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA. Electronic address: Stella_Ngo@eisai.com.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Steinhoff', 'Affiliation': 'Kork Epilepsy Centre, Landstraße 1, 77694, Kehl-Kork, Germany. Electronic address: BSteinhoff@epilepsiezentrum.de.'}]",Seizure,['10.1016/j.seizure.2020.06.011']
1295,32563863,DHA-enriched fish oil reduces insulin resistance in overweight and obese adults.,"Adipose tissue inflammation is major factor in the development of insulin resistance (IR). Long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) are anti-inflammatory bioactive lipids, thus may protect against type 2 diabetes (T2D) development. Previous research has demonstrated a sex-dependent association between LCn-3PUFA and T2D, and evidence suggests LCn-3PUFA may improve IR in a sex-dependent manner. This double-blind, randomized, parallel-arm placebo-controlled study aimed to determine whether DHA-enriched fish oil (FO) supplementation improves IR. Sex-dependent effects were assessed by testing for an interaction between sex and treatment in the multiple regression models. Men and women with abdominal obesity (waist circumference: males, ≥102 cm; females, ≥88 cm) and without diabetes were recruited from the community. Participants (age: 50.9 ± 12.7 years, female: 63.7%, BMI: 32.4 ± 6.6 kg/m 2 ) were randomly allocated to either 2 g FO (860 mg DHA + 120 mg EPA) (intervention, n = 38) or 2 g corn oil (CO) /day (control, n = 35) for 12 weeks in a double-blind randomised controlled trial. A fasting blood sample was collected at 0 and 12 weeks for assessment of IR, glucose and blood lipid profile. Sixty-eight participants completed the intervention. Compared with CO (n = 32), FO (n = 36) significantly reduced fasting insulin by -1.62 μIU/L (95%CI: -2.99, -0.26,) (p = 0.021) and HOMA-IR by -0.40 units (95%CI: -0.78, -0.02, p = 0.038). Higher insulin and HOMA-IR at baseline were associated with greater reductions in the FO group (p < 0.001). There was no interaction between sex and treatment for the change in insulin (p-interaction sex*treatment  = 0.816) or HOMA-IR (p-interaction sex*treatment  = 0.825). DHA-enriched FO reduces IR in adults with abdominal obesity, however, sex-dependent differences were not evident in this study.",2020,Higher insulin and HOMA-IR at baseline were associated with greater reductions in the FO group (p < 0.001).,"['overweight and obese adults', 'Participants (age: 50.9\xa0±\xa012.7 years, female: 63.7%, BMI: 32.4\xa0±\xa06.6\xa0kg/m 2 ', 'adults with abdominal obesity', 'Men and women with abdominal obesity (waist circumference: males, ≥102\xa0cm; females, ≥88\xa0cm) and without diabetes were recruited from the community']","['FO (860\xa0mg DHA\xa0+\xa0120\xa0mg EPA) (intervention, n\xa0=\xa038) or 2\xa0g corn oil (CO', 'μIU/L (95%CI', 'DHA-enriched FO', 'DHA-enriched fish oil (FO) supplementation', 'CO', 'Long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA', 'DHA-enriched fish oil', 'placebo']","['HOMA-IR', 'insulin resistance', 'IR, glucose and blood lipid profile', 'Higher insulin and HOMA-IR', 'fasting insulin']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517709', 'cui_str': '32.4'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0311277', 'cui_str': 'Abdominal Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0020459', 'cui_str': 'Hyperinsulinism'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",68.0,0.375942,Higher insulin and HOMA-IR at baseline were associated with greater reductions in the FO group (p < 0.001).,"[{'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Abbott', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Burrows', 'Affiliation': 'Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia; School of Health Sciences, University of Newcastle, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': 'School of Public Health and Medicine, University of Newcastle, Australia; Department of Endocrinology and Diabetes, John Hunter Hospital, Newcastle, Australia.'}, {'ForeName': 'R N', 'Initials': 'RN', 'LastName': 'Thota', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia; Riddet Institute, Massey University, Palmerston North, New Zealand.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Garg', 'Affiliation': 'Nutraceuticals Research Program, School of Biomedical Sciences & Pharmacy, University of Newcastle, Australia; Priority Research Centre for Physical Activity and Nutrition, University of Newcastle, Australia; Riddet Institute, Massey University, Palmerston North, New Zealand. Electronic address: manohar.garg@newcastle.edu.au.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102154']
1296,32563939,Association of Meteorin-Like Hormone with insulin resistance and body composition in healthy Iranian adults.,"BACKGROUND AND AIMS


Sedentary behavior and/or physical inactivity are modifiable risk factors for noncommunicable diseases. Myokines are one of the mediators of physical activity health benefits. Relationship between regular physical activity (RPA) and baseline plasma Meteorin-Like Hormone (Metrnl) has not been explored in human. Hence, we compared baseline plasma Metrnl between sedentary individuals and ones with recreational physical activities, and role of Metrnl as a biological messenger between physical activity and insulin resistance and body composition was also explored.
METHODS


Forty healthy young men (aged: 21 ± 2.1 yrs; BMI: 23 ± 3.44 kg/m 2 ) completed the study. Participants were equally assigned into two groups of control (sedentary) and case (recreational athletes). Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions.
RESULTS


Except for baseline blood glucose, baseline plasma Metrnl, insulin, HOMA-IR and body mass index and body fat percentage were similar between two groups (P > 0.05). However, after Metrnl correction for the degree of insulin resistance index (Metrnl/HOMA-IR), recreational athletes showed a significantly greater baseline compared to sedentary subjects (P < 0.05). Baseline blood glucose showed a negative and significant correlation with baseline plasma Metrnl (P < 0.05).
CONCLUSIONS


Baseline plasma Metrnl is correlated with regular physical activity and insulin sensitivity, but not with body composition parameters. Metrnl may be one possible mediator of the beneficial effects of PA on insulin sensitivity in healthy humans. Hence, increasing awareness of the benefits of physical activity and incorporating physical activity into lifestyle are of great importance for people with non-communicable diseases.",2020,"Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions.
","['healthy humans', 'Forty healthy young men (aged: 21\xa0±\xa02.1\xa0yrs', 'people with non-communicable diseases', 'healthy Iranian adults']","['Meteorin-Like Hormone with insulin resistance and body composition', 'regular physical activity (RPA) and baseline plasma Meteorin-Like Hormone (Metrnl']","['Baseline blood glucose', 'degree of insulin resistance index (Metrnl/HOMA-IR', 'baseline plasma Metrnl', 'baseline blood glucose, baseline plasma Metrnl, insulin, HOMA-IR and body mass index and body fat percentage', 'Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",40.0,0.0269477,"Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions.
","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Alizadeh', 'Affiliation': 'Faculty of Sport Sciences, University of Mazandaran, Babolsar, Mazandaran, Iran. Electronic address: h.alizadeh.aw@gmail.com.'}, {'ForeName': 'Aliakbar', 'Initials': 'A', 'LastName': 'Alizadeh', 'Affiliation': 'Department of Sport Physiology, Faculty of Sport Sciences, Shahid Chamran University of Ahvaz, Ahvaz, Iran. Electronic address: aliakbar.alizadeh1984@gmail.com.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.031']
1297,32565127,Comparison of Overall Survival Between De Novo and Secondary Acute Lymphoblastic Leukemia Patients of Different Ages.,"PURPOSE


To compare the overall survival (OS) between de novo and secondary acute lymphoblastic leukemia (ALL) patients in different age groups after chemotherapy.
PATIENTS AND METHODS


Data from 8305 ALL patients undergoing chemotherapy from the Surveillance, Epidemiology, and End Results (SEER) database during 1975 to 2015 were included in this study, of which 7454 (80.11%) were in the de novo ALL group, and 851 (19.89%) were in the secondary ALL (sALL) group. Propensity matching was used before comparison of OS between the two groups.
RESULTS


Female ALL patients had a lower risk of death than male (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.88-0.98; P < .01). The mortality of black patients was higher than in white patients (HR, 1.29; 95% CI, 1.18-1.42; P < .001). Patients aged 45-75 years (HR, 1.82; 95% CI, 1.72-1.94; P < .001) and ≥ 75 years (HR, 3.85; 95% CI, 3.52-4.23; P < .001) had a higher risk of death. Separated/divorced (HR, 1.21; 95% CI, 1.10-1.34; P < .001) and widowed (HR, 1.35; 95% CI, 1.21-1.51; P < .001) patients had a higher risk of death than single patients. sALL patients had a higher risk of death than de novo ALL patients (HR, 1.21; 95% CI, 1.12-1.30; P < .001). The mean age of the de novo ALL group was lower than in the sALL group (51.05 vs. 60.25; P < .001) after the propensity score was matched, and the 1-, 2-, 3-, 4-, and 5-year OS of the de novo ALL group were higher than that of the sALL group aged 18-75 years (P < .001).
CONCLUSION


The survival rate of ALL decreased with increased age. Patients with sALL had poorer OS than de novo patients aged 18-75 years.",2020,"ALL group were higher than that of the sALL group aged 18-75 years (P < .001).
","['de novo and secondary acute lymphoblastic leukemia (ALL) patients in different age groups after chemotherapy', 'Data from 8305 ALL patients undergoing chemotherapy from the Surveillance, Epidemiology, and End Results (SEER) database during 1975 to 2015 were included in this study, of which 7454 (80.11%) were in the de novo ALL group, and 851 (19.89%) were in the secondary ALL (sALL) group', 'Acute Lymphoblastic Leukemia Patients of Different Ages']",['sALL'],"['risk of death', 'mortality of black patients', '5-year OS of the de novo', 'Overall Survival', 'poorer OS', 'overall survival (OS', 'survival rate of ALL']","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}]",,0.200058,"ALL group were higher than that of the sALL group aged 18-75 years (P < .001).
","[{'ForeName': 'Jiansheng', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'Department of Hematology, Guangzhou Red Cross Hospital, Jinan University, Guangzhou, PR China. Electronic address: jianshengz123@163.com.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Clinical Laboratory, Guangzhou Red Cross Hospital, Jinan University, Guangzhou, PR China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Hematology, Guangzhou Red Cross Hospital, Jinan University, Guangzhou, PR China.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2020.04.013']
1298,32565465,"Study protocol for the safety and efficacy of probiotic therapy on days alive and out of hospital in adult ICU patients: the multicentre, randomised, placebo-controlled Restoration Of gut microflora in Critical Illness Trial (ROCIT).","INTRODUCTION


The effect of early and sustained administration of daily probiotic therapy on patients admitted to the intensive care unit (ICU) remains uncertain.
METHODS AND ANALYSIS


The Restoration Of gut microflora in Critical Illness Trial (ROCIT) study is a multicentre, randomised, placebo-controlled, parallel-group, two-sided superiority trial that will enrol 220 patients in five ICUs. Adult patients who are within 48 hours of admission to an ICU and are expected to require intensive care beyond the next calendar day will be randomised in a 1:1 ratio to receive early and sustained  Lactobacillus plantarum  299v probiotic therapy in addition to usual care or placebo in addition to usual care. The primary endpoint is days alive and out of hospital to day 60.
ETHICS AND DISSEMINATION


ROCIT has been approved by the South Metropolitan Health Service Human Research Ethics Committee (ref: RGS00000004) and the St John of God Health Care Human Research Ethics Committee (ref: 1183). The trial results will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


Australian and New Zealand Clinical Trials Registry (ANZCTR12617000783325); Pre-results.",2020,The Restoration Of gut microflora in Critical Illness Trial,"['patients admitted to the intensive care unit (ICU', 'Australian and New Zealand', 'days alive and out of hospital in adult ICU patients', 'Adult patients who are within 48\u2009hours of admission to an ICU and are expected to require intensive care beyond the next calendar day will be randomised in a 1:1 ratio to receive early and sustained', 'enrol 220 patients in five ICUs']","['Lactobacillus plantarum  299v probiotic therapy', 'probiotic therapy', 'daily probiotic therapy', 'placebo']",['days alive and out of hospital to day 60'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C1516147', 'cui_str': 'Calendars'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4517650', 'cui_str': '220'}]","[{'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C2242626', 'cui_str': 'Probiotic therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",,0.364712,The Restoration Of gut microflora in Critical Illness Trial,"[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia ed.litton@health.wa.gov.au.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Anstey', 'Affiliation': 'Intensive Care Unit, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Broadhurst', 'Affiliation': 'School of Science, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Andy R', 'Initials': 'AR', 'LastName': 'Chapman', 'Affiliation': 'Intensive Care Unit, Royal Perth Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Currie', 'Affiliation': 'Murdoch University, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Ferrier', 'Affiliation': 'Intensive Care Unit, St John of God Hospital, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Gummer', 'Affiliation': 'Murdoch University, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Higgins', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Jolene', 'Initials': 'J', 'LastName': 'Lim', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Laurens', 'Initials': 'L', 'LastName': 'Manning', 'Affiliation': 'University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Erina', 'Initials': 'E', 'LastName': 'Myers', 'Affiliation': 'Intensive Care Unit, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Orr', 'Affiliation': 'Pharmacy, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Palermo', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Paparini', 'Affiliation': 'Murdoch University, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Pellicano', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Raby', 'Affiliation': 'Department of Infectious Diseases, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Rammohan', 'Affiliation': 'Department of Economics, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Regli', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Richter', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, Western Australia, Australia.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Salman', 'Affiliation': 'University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Strunk', 'Affiliation': 'Neonatal Directorate, King Edward Memorial Hospital for Women Perth, Subiaco, Western Australia, Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Waterson', 'Affiliation': 'Intensive Care Unit, Royal Perth Hospital, Perth, Western Australia, Australia.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Wibrow', 'Affiliation': 'Intensive Care Unit, Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Wood', 'Affiliation': 'University of Western Australia, Perth, Western Australia, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-035930']
1299,32565467,Getting evidence into clinical practice: protocol for evaluation of the implementation of a home-based cardiac rehabilitation programme for patients with heart failure.,"INTRODUCTION


Cardiac rehabilitation (CR) improves health-related quality of life and reduces hospital admissions. However, patients with heart failure (HF) often fail to attend centre-based CR programmes. Novel ways of delivering healthcare, such as home-based CR programmes, may improve uptake of CR. Rehabilitation EnAblement in CHronic Heart Failure (REACH-HF) is a new, effective and cost-effective home-based CR programme for people with HF. The aim of this prospective mixed-method implementation evaluation study is to assess the implementation of the REACH-HF CR programme in the UK National Health Service (NHS). The specific objectives are to (1) explore NHS staff perceptions of the barriers and facilitators to the implementation of REACH-HF, (2) assess the quality of delivery of the programme in real-life clinical settings, (3) consider the nature of any adaptation(s) made and how they might impact on intervention effectiveness and (4) compare real-world patient outcomes to those seen in a prior clinical trial.
METHODS AND ANALYSIS


REACH-HF will be rolled out in four NHS CR centres across the UK. Three healthcare professionals from each site will be trained to deliver the 12-week programme. In-depth qualitative interviews and focus groups will be conducted with approximately 24 NHS professionals involved in delivering or commissioning the programme. Consultations for 48 patients (12 per site) will be audio recorded and scored using an intervention fidelity checklist. Outcomes routinely recorded in the National Audit of Cardiac Rehabilitation will be analysed and compared with outcomes from a recent randomised controlled trial: the Minnesota Living with HF Questionnaire and exercise capacity (Incremental Shuttle Walk Test). Qualitative research findings will be mapped onto the Normalisation Process Theory framework and presented in the form of a narrative synthesis. Results of the study will inform national roll-out of REACH-HF.
ETHICS AND DISSEMINATION


The study (IRAS 261723) has received ethics approval from the South Central (Hampshire B) Research Ethics Committee (19/SC/0304). Written informed consent will be obtained from all health professionals and patients participating in the study. The research team will ensure that the study is conducted in accordance with the Declaration of Helsinki, the Data Protection Act 2018, General Data Protection Regulations and in accordance with the Research Governance Framework for Health and Social Care (2005). Findings will be published in scientific peer-reviewed journals and presented at local, national and international meetings to publicise and explain the research methods and findings to key audiences to facilitate the further uptake of the REACH-HF intervention.
TRIAL REGISTRATION


ISRCTN86234930.",2020,In-depth qualitative interviews and focus groups will be conducted with approximately 24 NHS professionals involved in delivering or commissioning the programme.,"['people with HF', 'patients with heart failure', 'patients with heart failure (HF', '48 patients (12 per site']","['REACH-HF CR programme', 'Minnesota Living with HF Questionnaire and exercise capacity (Incremental Shuttle Walk Test', 'Cardiac rehabilitation (CR']",['health-related quality of life and reduces hospital admissions'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]",,0.10218,In-depth qualitative interviews and focus groups will be conducted with approximately 24 NHS professionals involved in delivering or commissioning the programme.,"[{'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Daw', 'Affiliation': 'School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham, Birmingham, UK pxd891@student.bham.ac.uk.'}, {'ForeName': 'Samantha B', 'Initials': 'SB', 'LastName': 'van Beurden', 'Affiliation': 'Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Greaves', 'Affiliation': 'School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jet J C S', 'Initials': 'JJCS', 'LastName': 'Veldhuijzen van Zanten', 'Affiliation': 'School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Harrison', 'Affiliation': 'Health Sciences, University of York, York, UK.'}, {'ForeName': 'Hasnain', 'Initials': 'H', 'LastName': 'Dalal', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Sinead T J', 'Initials': 'STJ', 'LastName': 'McDonagh', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Doherty', 'Affiliation': 'Health Sciences, University of York, York, UK.'}, {'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': 'College of Medicine and Health, University of Exeter, Exeter, UK.'}]",BMJ open,['10.1136/bmjopen-2019-036137']
1300,32565469,Effect of early cryoprecipitate transfusion versus standard care in women who develop severe postpartum haemorrhage (ACROBAT) in the UK: a protocol for a pilot cluster randomised trial.,"INTRODUCTION


The incidence of severe postpartum haemorrhage (PPH) that requires blood transfusion is on the increase. Fibrinogen levels have been shown to drop early and significantly during PPH, which is associated with worse outcomes. Early fibrinogen replacement could potentially improve outcomes. No studies have investigated the clinical impact of early cryoprecipitate transfusion in PPH. Prior to performing a full-scale trial, a pilot study is needed to determine feasibility of the intervention and recruitment.
METHODS


ACROBAT is a cluster-randomised pilot study with a qualitative evaluation. Four large London maternity units are randomised to either the intervention or control group. The intervention group will adapt their major obstetric haemorrhage procedures to administer cryoprecipitate early for primary PPH. The control group will retain their standard of care.We include women at >24 weeks gestation who are actively bleeding within 24 hours of delivery and for whom transfusion of red blood cells (RBCs) has been started. We exclude women who decline blood transfusions in advance or have inherited Factor XIII or fibrinogen deficiency. Due to the emergency nature of the intervention, informed consent for administering the intervention is waived.The primary objective is to assess the feasibility of administering cryoprecipitate within 90 min of RBC request, as compared with standard treatment where cryoprecipitate is given later or not at all. Secondary objectives include the feasibility of recruitment and data collection, reasons for and barriers to consent, preliminary maternal clinical outcomes, identification of the optimal infrastructure pathways for study delivery, and acceptability of the intervention and outcomes.
ETHICS AND DISSEMINATION


The trial has approvals from the London-Brighton & Sussex Research Ethics Committee (ref. 18/LO/2062), the Confidentiality Advisory Group (ref. 18/CAG/0199) and Health Research Authority (IRAS number 237959). Data analysis and publication of manuscripts will start in Q3 2020.
TRIAL REGISTRATION NUMBER


ISRCTN12146519.",2020,"The primary objective is to assess the feasibility of administering cryoprecipitate within 90 min of RBC request, as compared with standard treatment where cryoprecipitate is given later or not at all.","['Four large London maternity units', 'women who decline blood transfusions in advance or have inherited Factor XIII or fibrinogen deficiency', 'women at >24 weeks gestation who are actively bleeding within 24\u2009hours of delivery and for whom transfusion of red blood cells (RBCs) has been started', 'women who develop severe postpartum haemorrhage (ACROBAT) in the UK']",['early cryoprecipitate transfusion versus standard care'],"['Fibrinogen levels', 'feasibility of recruitment and data collection, reasons for and barriers to consent, preliminary maternal clinical outcomes, identification of the optimal infrastructure pathways for study delivery, and acceptability of the intervention and outcomes', 'severe postpartum haemorrhage (PPH']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0015528', 'cui_str': 'factor XIII'}, {'cui': 'C4316812', 'cui_str': 'Fibrinogen deficiency'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0443121', 'cui_str': 'Cryoprecipitate'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0337428', 'cui_str': 'Fibrinogen assay'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}]",,0.137309,"The primary objective is to assess the feasibility of administering cryoprecipitate within 90 min of RBC request, as compared with standard treatment where cryoprecipitate is given later or not at all.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Green', 'Affiliation': 'Blizard Institute, Queen Mary University of London, London, UK Laura.Green27@nhs.net.'}, {'ForeName': 'Jahnavi', 'Initials': 'J', 'LastName': 'Daru', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dodds', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Francisco Jose', 'Initials': 'FJ', 'LastName': 'Gonzalez Carreras', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Lanz', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zamora', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Maria Del Carmen', 'Initials': 'MDC', 'LastName': 'Pardo Llorente', 'Affiliation': 'Department of Statistics and Operational Research, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Pérez Pérez', 'Affiliation': 'Department of Statistics and Data Science, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Sweeney', 'Affiliation': 'Institute for Health and Human Development, University of East London, London, UK.'}, {'ForeName': 'Shakila', 'Initials': 'S', 'LastName': 'Thangaratinam', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': ""Department of Women's and Neonatal Health, Royal London Hospital, Barts Health NHS Trust, London, UK.""}, {'ForeName': 'Khalid Saeed', 'Initials': 'KS', 'LastName': 'Khan', 'Affiliation': ""Barts Research Centre for Women's Health (BARC), Institute of Population Health Sciences, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.""}]",BMJ open,['10.1136/bmjopen-2019-036416']
1301,32565474,Pulse oximeter with integrated management of childhood illness for diagnosis of severe childhood pneumonia at rural health institutions in Southern Ethiopia: results from a cluster-randomised controlled trial.,"OBJECTIVE


To assess whether pulse oximetry improves health workers' performance in diagnosing severe childhood pneumonia at health centres in Southern Ethiopia.
DESIGN


Parallel cluster-randomised trial.
SETTING


Government primary health centres.
PARTICIPANTS


Twenty-four health centres that treat at least one pneumonia case per day in Southern Ethiopia. Children aged between 2 months and 59 months who present at health facilities with cough or difficulty breathing were recruited in the study from September 2018 to April 2019.
INTERVENTION ARM


Use of the Integrated Management of Childhood Illness (IMCI) algorithm and pulse oximeter.
CONTROL ARM


Use of the IMCI algorithm only.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcome was the proportion of children diagnosed with severe pneumonia. Secondary outcomes included referred cases of severe pneumonia and treatment failure on day 14 after enrolment.
RESULT


Twenty-four health centres were randomised into intervention (928 children) and control arms (876 children). The proportion of children with severe pneumonia was 15.9% (148 of 928 children) in the intervention arm and 3.9% (34 of 876 children) in the control arm. After adjusting for differences in baseline variables children in the intervention arm were more likely to be diagnosed as severe pneumonia cases as compared with those in the control arm (adjusted OR: 5.4, 95% CI 2.0 to 14.3, p=0.001).
CONCLUSION


The combined use of IMCI and pulse oximetry in health centres increased the number of diagnosed severe childhood pneumonia.
TRIAL REGISTRATION NUMBER


PACTR201807164196402.",2020,The proportion of children with severe pneumonia was 15.9% (148 of 928 children) in the intervention arm and 3.9% (34 of 876 children) in the control arm.,"['diagnosing severe childhood pneumonia at health centres in Southern Ethiopia', 'Children aged between 2 months and 59 months who present at health facilities with cough or difficulty breathing were recruited in the study from September 2018 to April 2019', 'Government primary health centres', 'childhood illness for diagnosis of severe childhood pneumonia at rural health institutions in Southern Ethiopia', 'Twenty-four health centres that treat at least one pneumonia case per day in Southern Ethiopia', 'Twenty-four health centres']","['Pulse oximeter with integrated management', 'pulse oximetry', 'IMCI and pulse oximetry', 'ARM\n\n\nUse of the Integrated Management of Childhood Illness (IMCI) algorithm and pulse oximeter']","['referred cases of severe pneumonia and treatment failure on day 14 after enrolment', ""health workers' performance"", 'severe pneumonia cases', 'proportion of children diagnosed with severe pneumonia', 'proportion of children with severe pneumonia']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0034108', 'cui_str': 'Pulse oximetry'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.256355,The proportion of children with severe pneumonia was 15.9% (148 of 928 children) in the intervention arm and 3.9% (34 of 876 children) in the control arm.,"[{'ForeName': 'Solomon H', 'Initials': 'SH', 'LastName': 'Tesfaye', 'Affiliation': 'School of Public Health, Hawassa University College of Medicine and Health Sciences, Hawassa, Ethiopia solomon0917242124@gmail.com.'}, {'ForeName': 'Yabibal', 'Initials': 'Y', 'LastName': 'Gebeyehu', 'Affiliation': 'School of Medicine, Dilla University College of Health Sciences, Dilla, Ethiopia.'}, {'ForeName': 'Eskindir', 'Initials': 'E', 'LastName': 'Loha', 'Affiliation': 'School of Public Health, Hawassa University College of Medicine and Health Sciences, Hawassa, Ethiopia.'}, {'ForeName': 'Kjell Arne', 'Initials': 'KA', 'LastName': 'Johansson', 'Affiliation': 'Global Public Health and Primary Care, University of Bergen Centre for International Health, Bergen, Norway.'}, {'ForeName': 'Bernt', 'Initials': 'B', 'LastName': 'Lindtjørn', 'Affiliation': 'School of Public Health, Hawassa University College of Medicine and Health Sciences, Hawassa, Ethiopia.'}]",BMJ open,['10.1136/bmjopen-2020-036814']
1302,32569757,"A prospective, multi-center randomized, controlled, blinded trial of vagus nerve stimulation for difficult to treat depression: A novel design for a novel treatment.","Few treatment options exist for patients with difficult-to-treat depression (DTD). One potentially efficacious treatment is vagus nerve stimulation (VNS): chronic stimulation of the vagus nerve using an implanted stimulator. Given a series of recent VNS clinical studies, including a large, five-year naturalistic investigation, the Center for Medicare and Medicaid Services (CMS) reconsidered the previous non coverage determination and announced coverage for patients participating in a ""coverage with evidence"" trial. This study, entitled, A PRospective, Multi-cEnter, Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER), includes DTD patients with at least four unsuccessful antidepressant treatments in the current episode and will randomize both unipolar and bipolar DTD participants, each up to 500 evaluable enrollees. Predetermined interim analyses will define the necessary sample size. All participants will be implanted with VNS devices: half receive active stimulation during year one, and half receive delayed stimulation after year one. Participants will be followed for 5 years. This RCT is unique for DTD studies: 1) large sample size and long study duration (one year of controlled comparison); 2) use of a percent time in response as the primary outcome measure, given the chronic illness and its fluctuating course (vis-à-vis meeting a response criteria at a single time point); 3) inclusion of diverse measures of VNS impact on function, including quality of life, degree of disability, health status, and suicidality.",2020,Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy,"['depression', 'patients with difficult-to-treat depression (DTD', 'Subjects With Treatment-Resistant Depression (RECOVER), includes DTD patients with at least four unsuccessful antidepressant treatments in the current episode and will randomize both unipolar and bipolar DTD participants, each up to 500 evaluable enrollees']","['vagus nerve stimulation', 'VNS Therapy® System as AdjunctivE Therapy']","['quality of life, degree of disability, health status, and suicidality']","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0220726', 'cui_str': 'Diastrophic dysplasia'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3816747', 'cui_str': '500'}]","[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",,0.0937023,Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy,"[{'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Conway', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, 660 S. Euclid Ave, Campus Box 8134, St. Louis, MO 63110, USA. Electronic address: conwaycr@wustl.edu.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Olin', 'Affiliation': 'LivaNova PLC, London, United Kingdom. Electronic address: bryan.olin@livanova.com.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Aaronson', 'Affiliation': 'Sheppard Pratt Health System, Department of Psychiatry, University of Maryland, Baltimore, MD, USA. Electronic address: SAaronson@sheppardpratt.org.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Departments of Psychiatry and Radiology, Columbia University, New York, NY, USA. Electronic address: has1@columbia.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bunker', 'Affiliation': 'LivaNova PLC, Houston, TX, USA. Electronic address: Mark.Bunker@livanova.com.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Kriedt', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, 660 S. Euclid Ave, Campus Box 8134, St. Louis, MO 63110, USA. Electronic address: ckriedt@wustl.edu.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Greco', 'Affiliation': 'LivaNova PLC, SORIN Group Italia S.r.l., Milano, Italy. Electronic address: teresa.greco@livanova.com.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Broglio', 'Affiliation': 'Department of Statistics and Data Sciences, University of Texas, Austin, TX, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Vestrucci', 'Affiliation': 'Berry Consultants, Austin, TX, USA; Department of Statistics and Data Sciences, University of Texas, Austin, TX, USA. Electronic address: matteo@berryconsultants.net.'}, {'ForeName': 'A John', 'Initials': 'AJ', 'LastName': 'Rush', 'Affiliation': 'Duke-NUS Medical School, Singapore; Duke University, Durham, NC, USA; Texas Tech University, Permian Basin, TX, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106066']
1303,32569854,Improving imagery rescripting treatments: Comparing an active versus passive approach.,"BACKGROUND AND OBJECTIVES


In imagery rescripting (ImRs), aversive mental images are modified to reduce symptoms in a variety of psychological disorders. However, uniform guidelines on how to optimally implement ImRs do currently not exist. It remains unclear whether therapists should stimulate patients to imagine themselves to actively intervene within the new image, or whether they may imagine helpers to change the situation. We aimed to compare these two variants of ImRs within an analogue experimental setting.
METHODS


After having watched an aversive film, one-hundred participants were randomly assigned to active ImRs (ImRs-A), passive ImRs (ImRs-P), imagery rehearsal (IRE), or no-intervention control (NIC). Participants were either instructed to rescript the film by imagining themselves intervening in the new script (ImRs-A) or encouraged to imagine helpers to intervene in the imagined situation (ImRs-P).
RESULTS


Both ImRs increased mastery and elicited less distress than IRE with ImRs-P being experienced as less distressing than ImRs-A. Only ImRs-A led to a stronger increase in positive affect than IRE, whereas groups did not differ with respect to negative affect and self-efficacy. Conditions did not differ regarding the number of film-related intrusive memories.
LIMITATIONS


As a convenience sample was investigated, results cannot be generalized to clinical samples.
CONCLUSION


Even though differences regarding symptomatic outcome could not be detected, ImRs-P was experienced as less distressing than ImRs-A. Results suggest that both ImRs lead to different processes during the intervention than mere exposure. Compared to IRE, ImRs increases mastery with ImRs-A and ImRs-P being equally effective.",2020,"Both ImRs increased mastery and elicited less distress than IRE with ImRs-P being experienced as less distressing than ImRs-A. Only ImRs-A led to a stronger increase in positive affect than IRE, whereas groups did not differ with respect to negative affect and self-efficacy.","['After having watched an aversive film, one-hundred participants']","['active ImRs (ImRs-A), passive ImRs (ImRs-P), imagery rehearsal (IRE), or no-intervention control (NIC', 'instructed to rescript the film by imagining themselves intervening in the new script (ImRs-A) or encouraged to imagine helpers to intervene in the imagined situation (ImRs-P']",['number of film-related intrusive memories'],"[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1704608', 'cui_str': 'Film'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories'}]",100.0,0.0317839,"Both ImRs increased mastery and elicited less distress than IRE with ImRs-P being experienced as less distressing than ImRs-A. Only ImRs-A led to a stronger increase in positive affect than IRE, whereas groups did not differ with respect to negative affect and self-efficacy.","[{'ForeName': 'Marena', 'Initials': 'M', 'LastName': 'Siegesleitner', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Strohm', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Wittekind', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ehring', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Kunze', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany. Electronic address: anna.kunze@psy.lmu.de.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101578']
1304,32462341,Retro-equatorial inferior oblique myopexy for treatment of inferior oblique overaction.,"AIM


To compare the effectiveness of inferior oblique retroequatorial myopexy and inferior oblique myectomy in correction of inferior oblique overaction (IOOA).
PATIENTS AND METHODS


This was a pilot study study including forty patients with primary IOOA of all grades, with or without primary position horizontal deviations. Patients were randomized to have either IO retroequatorial myopexy, group A, or IO myectomy, group B. Success was defined as elimination of the IOOA at 6 months postoperatively. Secondary outcome measures included residual or recurrent elevation in adduction, development of postoperative hypotropia in adduction, postoperative contralateral IOOA, major intraoperative complications, and reversibility of the procedure.
RESULTS


At 6 months postoperative, the success rate was higher in the myectomy group (76%) than in the myopexy group (58%); however, this difference was not statistically significant (P = 0.1). The incidence of residual IOOA in myopexy group was significantly higher in patients with higher preoperative grades of IOOA (P ˂ 0.001). While this difference was not statistically significant among patients in myectomy group (P = 0.09). Collapse of V-pattern was acheived in nine (69%) patients in myopexy group compared with 8 (57%) in myectomy group with a statistically significant difference (P ≤ 0.001). No patients in myopexy group developed postoperative hypotropia in adduction or postoperative contralateral IOOA, compared with eight (22%) patients of myectomy group (P = 0.002) who developed postoperative hypotropia and two (66.6%) patients with unilateral IOOA who developed contralateral IOOA in myectomy group (P ˂ 0.001). No intraoperative complications were encountered in either group. postoperative.
CONCLUSIONS


Retroequatorial myopexy of the inferior oblique is as effective as inferior oblique myectomy in eliminating lower and moderate grades of primary IOOA; however, it is more effective in collapsing V-pattern associated with IOOA, and is not associated with postoperative hypotropia or contralateral IOOA after unilateral surgery. It can be used as a safe, reversible alternative to myectomy; however, it is not suitable for high grades of IOOA.",2020,"At 6 months postoperative, the success rate was higher in the myectomy group (76%) than in the myopexy group (58%); however, this difference was not statistically significant (P = 0.1).","['forty patients with primary IOOA of all grades, with or without primary position horizontal deviations']","['Retro-equatorial inferior oblique myopexy', 'IO retroequatorial myopexy', 'inferior oblique retroequatorial myopexy and inferior oblique myectomy']","['intraoperative complications', 'contralateral IOOA', 'postoperative hypotropia', 'incidence of residual IOOA', 'Collapse of V-pattern', 'postoperative hypotropia in adduction or postoperative contralateral IOOA', 'success rate', 'residual or recurrent elevation in adduction, development of postoperative hypotropia in adduction, postoperative contralateral IOOA, major intraoperative complications, and reversibility of the procedure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1276001', 'cui_str': 'Inferior oblique overaction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0444508', 'cui_str': 'Primary position'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0582817', 'cui_str': 'Inferior oblique muscle structure'}, {'cui': 'C0395358', 'cui_str': 'Inferior oblique myectomy'}]","[{'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C1276001', 'cui_str': 'Inferior oblique overaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0152208', 'cui_str': 'Hypotropia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0231457', 'cui_str': 'Adduction'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0449261', 'cui_str': 'Reversibility'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",40.0,0.0367,"At 6 months postoperative, the success rate was higher in the myectomy group (76%) than in the myopexy group (58%); however, this difference was not statistically significant (P = 0.1).","[{'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Kasem', 'Affiliation': 'Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Metwally', 'Affiliation': 'Memorial Institute of Ophthalmic Research, Giza, Egypt.'}, {'ForeName': 'Ibrahim T', 'Initials': 'IT', 'LastName': 'El-Adawy', 'Affiliation': 'Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ameera G', 'Initials': 'AG', 'LastName': 'Abdelhameed', 'Affiliation': 'Faculty of Medicine, Mansoura University, Mansoura, Egypt. amiragamal287@gmail.com.'}]",Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie,['10.1007/s00417-020-04742-4']
1305,32467339,Particle depletion of diesel exhaust restores allergen-induced lung-protective surfactant protein D in human lungs.,"RATIONALE


Exposure to air pollution is linked with increased asthma morbidity and mortality. To understand pathological processes linking air pollution and allergen exposures to asthma pathophysiology, we investigated the effect of coexposure to diesel exhaust (DE) and aeroallergen on immune regulatory proteins in human airways.
METHODS


Fourteen allergen-sensitised participants completed this randomised, double-blinded, cross-over, controlled exposure study. Each participant underwent four exposures (allergen-alone exposure, DE and allergen coexposure, particle-depleted DE (PDDE) and allergen coexposure, and sham exposure) on different order-randomised dates, each separated by a 4-week washout. Serum and bronchoalveolar lavage (BAL) were assayed for pattern recognition molecules, cytokines, chemokines and inflammatory mediators.
RESULTS


In human airways, allergen-alone exposure led to accumulation of surfactant protein D (SPD; p=0.02). Coexposure to allergen and DE did not elicit the same increase of SPD as did allergen alone; diesel particulate reduction restored allergen-induced SPD accumulation. Soluble receptor for advanced glycation end products was higher with particle reduction than without it. In the systemic circulation, there was a transient increase in SPD and club cell protein 16 (CC16) 4 hours after allergen alone. CC16 was augmented by PDDE, but not DE. % eosinophils in BAL (p<0.005), eotaxin-3 (p<0.0001), interleukin 5 (IL-5; p<0.0001) and thymus and activation regulated chemokine (p=0.0001) were each increased in BAL by allergen. IL-5, SPD and % eosinophils in BAL were correlated with decreased FEV 1 .
CONCLUSION


Short-term coexposure to aeroallergen and DE alters immune regulatory proteins in lungs; surfactant levels are dependent on particle depletion.
TRIAL REGISTRATION NUMBER


NCT02017431.",2020,"% eosinophils in BAL (p<0.005), eotaxin-3 (p<0.0001), interleukin 5 (IL-5; p<0.0001) and thymus and activation regulated chemokine (p=0.0001) were each increased in BAL by allergen.","['human airways', 'Fourteen allergen-sensitised participants', 'human lungs']","['four exposures (allergen-alone exposure, DE and allergen coexposure, particle-depleted DE (PDDE) and allergen coexposure, and sham exposure', 'coexposure to diesel exhaust (DE', 'diesel exhaust restores allergen-induced lung-protective surfactant protein D']","['CC16', 'asthma morbidity and mortality', 'IL-5, SPD and % eosinophils in BAL', 'Serum and bronchoalveolar lavage (BAL', 'SPD and club cell protein']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0012151', 'cui_str': 'Diesel Exhaust'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0084692', 'cui_str': 'Surfactant Protein D'}]","[{'cui': 'C0225668', 'cui_str': 'Clara cell of bronchiole'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}, {'cui': 'C0084692', 'cui_str': 'Surfactant Protein D'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C1535502', 'cui_str': 'Bronchoalveolar lavage'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.106351,"% eosinophils in BAL (p<0.005), eotaxin-3 (p<0.0001), interleukin 5 (IL-5; p<0.0001) and thymus and activation regulated chemokine (p=0.0001) were each increased in BAL by allergen.","[{'ForeName': 'Min Hyung', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Vancouver Coastal Health Research Institute, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kevin Soon-Keen', 'Initials': 'KS', 'LastName': 'Lau', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Vancouver Coastal Health Research Institute, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Denise Jill', 'Initials': 'DJ', 'LastName': 'Wooding', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Vancouver Coastal Health Research Institute, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Vancouver Coastal Health Research Institute, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Don D', 'Initials': 'DD', 'LastName': 'Sin', 'Affiliation': ""Centre for Heart Lung Innovation, St. Paul's Hospital, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Carlsten', 'Affiliation': 'Air Pollution Exposure Laboratory, Department of Medicine, Vancouver Coastal Health Research Institute, The University of British Columbia Faculty of Medicine, Vancouver, British Columbia, Canada carlsten@mail.ubc.ca.'}]",Thorax,['10.1136/thoraxjnl-2020-214561']
1306,32565450,One-to-one befriending for people with intellectual disability and symptoms of depression: protocol for a pilot randomised controlled trial.,"INTRODUCTION


People with intellectual disability (ID) are more likely to experience loneliness and have smaller social networks, which increases vulnerability to depression. Befriending may reduce depressive symptoms in other populations, but randomised controlled trials (RCTs) have not been carried out in this population. This pilot study aims to assess the acceptability and feasibility of carrying out a full RCT of one-to-one befriending by volunteers for people with ID, compared with an active control group.
METHODS AND ANALYSIS


The trial aims to recruit 40 participants with ID. Participants in the intervention arm will receive weekly visits from a volunteer over 6 months. Community befriending schemes will recruit, train, supervise volunteers and match them to individuals with ID. Both groups will receive a booklet about local activities and have access to usual care. Health and social outcomes will be measured at the end of the intervention and 6 months' follow-up. The following outcomes will be assessed: (1) recruitment and retention of individuals with ID and volunteers in the trial, (2) adverse events related to the intervention, (3) the acceptability of the intervention, (4) whether the intervention is delivered as intended, (5) changes in health and social outcomes and (6) the feasibility of carrying out a cost-effectiveness analysis in a full trial. Qualitative data from participants, volunteers, staff and carers will identify barriers and facilitators of a future full trial.
ETHICS AND DISSEMINATION


The study has been approved by the London City and East Research Ethics Committee (reference 18/LO/2188). The findings will be presented at conferences and published in a peer-reviewed journal and in the National Institute of Health Research journals library. A public engagement seminar will be held at the end of the study aimed at key stakeholders.
TRIAL REGISTRATION NUMBER


ISRCTN63779614.",2020,"Befriending may reduce depressive symptoms in other populations, but randomised controlled trials (RCTs) have not been carried out in this population.","['volunteers for people with ID, compared with an active control group', 'People with intellectual disability (ID', 'people with intellectual disability and symptoms of depression', 'supervise volunteers and match them to individuals with ID', '40 participants with ID']",[],"['delivered as intended, (5) changes in health and social outcomes and (6) the feasibility of carrying out a cost-effectiveness analysis', 'depressive symptoms', 'Health and social outcomes']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],"[{'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",40.0,0.176178,"Befriending may reduce depressive symptoms in other populations, but randomised controlled trials (RCTs) have not been carried out in this population.","[{'ForeName': 'Afia', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Division of Psychiatry, University College London, London, UK afia.ali@ucl.ac.uk.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Mckenzie', 'Affiliation': 'Research and Development, North East London NHS Foundation Trust Goodmayes Hospital, Ilford, Essex, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Hassiotis', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Priebe', 'Affiliation': 'Unit of Social and Community Psychiatry, Barts and the London School of Medicine and Dentistry, University of London, London, UK.'}, {'ForeName': 'Brynmor', 'Initials': 'B', 'LastName': 'Lloyd-Evans', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Rumana', 'Initials': 'R', 'LastName': 'Omar', 'Affiliation': 'Department of Statistical Science, University College London, London, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Panca', 'Affiliation': 'Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Fernandez', 'Affiliation': 'Hackney Volunteer and Befriending Scheme, Outward, London, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Finning', 'Affiliation': 'Hackney Volunteer and Befriending Scheme, Outward, London, UK.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Moore', 'Affiliation': 'The Befriending Scheme, Sudbury, Suffolk, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': ""O'Connor"", 'Affiliation': 'The Befriending Scheme, Sudbury, Suffolk, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Roe', 'Affiliation': 'The Befriending Scheme, Sudbury, Suffolk, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}]",BMJ open,['10.1136/bmjopen-2019-033989']
1307,32565458,Study protocol for two complementary trials of non-steroidal or opioid analgesia use for children aged 6 to 17 years with musculoskeletal injuries (the No OUCH study).,"INTRODUCTION


Musculoskeletal (MSK) injuries are a frequent cause for emergency department (ED) visits in children. MSK injuries are associated with moderate-to-severe pain in most children, yet recent research confirms that the management of children's pain in the ED remains inadequate. Clinicians are seeking better oral analgesic options for MSK injury pain with demonstrated efficacy and an excellent safety profile. This study aims to determine the efficacy and safety of adding oral acetaminophen or oral hydromorphone to oral ibuprofen and interpret this information within the context of parent/caregiver preference.
METHODS AND ANALYSIS


Using a novel preference-informed complementary trial design, two simultaneous trials are being conducted. Parents/caregivers of children presenting to the ED with acute limb injury will be approached and they will decide which trial they wish to participate in: an opioid-inclusive trial or a non-opioid trial. Both trials will follow randomised, double-blind, placebo-controlled, superiority-trial methodology and will enrol a minimum of 536 children across six Canadian paediatric EDs. Children will be eligible if they are 6 to 17 years of age and if they present to the ED with an acute limb injury and a self-reported verbal Numerical Rating Scale pain score ≥5. The primary objective is to determine the effectiveness of oral ibuprofen+oral hydromorphone versus oral ibuprofen+oral acetaminophen versus oral ibuprofen alone. Recruitment was launched in April 2019.
ETHICS AND DISSEMINATION


This study has been approved by the Health Research Ethics Board (University of Alberta), and by appropriate ethics boards at all recruiting centres. Informed consent will be obtained from parents/guardians of all participants, in conjunction with assent from the participants themselves. Study data will be submitted for publication regardless of results. This study is funded through a Canadian Institutes of Health Research grant.
TRIAL REGISTRATION NUMBER


NCT03767933, first registered on 07 December 2018.",2020,The primary objective is to determine the effectiveness of oral ibuprofen+oral hydromorphone versus oral ibuprofen+oral acetaminophen versus oral ibuprofen alone.,"['Parents/caregivers of children presenting to the ED with acute limb injury', 'children aged 6 to 17 years with musculoskeletal injuries (the No OUCH study', '536 children across six Canadian paediatric EDs']","['non-steroidal or opioid analgesia', 'ibuprofen+oral acetaminophen', 'oral ibuprofen+oral hydromorphone', 'hydromorphone', 'ibuprofen', 'acetaminophen', 'placebo']","['efficacy and safety', 'verbal Numerical Rating Scale pain score ≥5']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0743668', 'cui_str': 'Limb injury'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0272448', 'cui_str': 'Injury of musculoskeletal system'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0012306', 'cui_str': 'Hydromorphone'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.346972,The primary objective is to determine the effectiveness of oral ibuprofen+oral hydromorphone versus oral ibuprofen+oral acetaminophen versus oral ibuprofen alone.,"[{'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Pediatrics, University of Alberta, Edmonton, Alberta, Canada sali@ualberta.ca.'}, {'ForeName': 'Manasi', 'Initials': 'M', 'LastName': 'Rajagopal', 'Affiliation': 'Pediatrics, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Klassen', 'Affiliation': ""Children's Hospital Research Institute of Manitoba, University of Manitoba, Winnipeg, Manitoba, Canada.""}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Richer', 'Affiliation': 'Pediatrics, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McCabe', 'Affiliation': 'Emergency Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Willan', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Maryna', 'Initials': 'M', 'LastName': 'Yaskina', 'Affiliation': ""Women and Children's Health Research Institute, University of Alberta, Edmonton, Alberta, Canada.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Heath', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Drendel', 'Affiliation': 'Pediatrics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Offringa', 'Affiliation': 'Child Health Evaluation Sciences, The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Gouin', 'Affiliation': 'Pediatrics, Universite de Montreal, Montreal, Québec, Canada.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Stang', 'Affiliation': 'Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Sawyer', 'Affiliation': 'Pediatrics and Emergency Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Maala', 'Initials': 'M', 'LastName': 'Bhatt', 'Affiliation': 'Pediatrics, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Hickes', 'Affiliation': ""Parent Partner, Children's Hospital Research Institute of Manitoba, University of Manitoba, Winnipeg, Manitoba, Canada.""}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Poonai', 'Affiliation': 'Paediatrics and Internal Medicine, Schulich School of Medicine & Dentistry, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035177']
1308,32565464,Standardised patient encounters to improve quality of counselling for pre-exposure prophylaxis (PrEP) in adolescent girls and young women (AGYW) in Kenya: study protocol of a cluster randomised controlled trial.,"INTRODUCTION


Adolescent girls and young women (AGYW) in sub-Saharan Africa are at high risk of HIV acquisition. Pre-exposure prophylaxis (PrEP) demonstration projects observe that AGYW uptake and adherence to PrEP during risk periods is suboptimal. Judgemental interactions with healthcare workers (HCW) and inadequate counselling can be barriers to PrEP use among AGYW. Improving HCW competency and communication to support PrEP delivery to AGYW requires new strategies.
METHODS AND ANALYSIS


PrEP Implementation for Young Women and Adolescents Program-standardised patient (PrIYA-SP) is a cluster randomised trial of a standardised patient actor (SP) training intervention designed to improve HCW adherence to PrEP guidelines and communication skills. We purposively selected 24 clinics offering PrEP services under fully programmatic conditions in Kisumu County, Kenya. At baseline, unannounced SP 'mystery shoppers' present to clinics portraying AGYW in common PrEP scenarios for a cross-sectional assessment of PrEP delivery. Twelve facilities will be randomised to receive a 2-day training intervention, consisting of lectures, role-playing with SPs and group debriefing. Unannounced SPs will repeat the assessment in all 24 sites following the intervention. The primary outcome is quality of PrEP counselling, including adherence to national guidelines and communication skills, scored on a checklist by SPs blinded to intervention assignment. An intention-to-treat (ITT) analysis will evaluate whether the intervention resulted in higher scores within intervention compared with control facilities, adjusted for baseline SP scores and accounting for clustering by facility. We hypothesise that the intervention will improve quality of PrEP counselling compared with standard of care. Results from this study will inform guidelines for PrEP delivery to AGYW in low-resource settings and offer a potentially scalable strategy to improve service delivery for this high-risk group.
ETHICS AND DISSEMINATION


The protocol was approved by institutional review boards at Kenyatta National Hospital and University of Washington. An external advisory committee monitors social harms. Results will be disseminated through peer-reviewed journals and presentations.
TRIAL REGISTRATION NUMBER


NCT03875950.",2020,Judgemental interactions with healthcare workers (HCW) and inadequate counselling can be barriers to PrEP use among AGYW.,"['purposively selected 24 clinics offering PrEP services under fully programmatic conditions in Kisumu County, Kenya', 'Young Women and Adolescents Program-standardised patient (PrIYA-SP', 'adolescent girls and young women (AGYW) in Kenya', 'Adolescent girls and young women (AGYW) in sub-Saharan Africa are at high risk of HIV acquisition']","['standardised patient actor (SP) training intervention', 'counselling for pre-exposure prophylaxis (PrEP', 'Pre-exposure prophylaxis (PrEP', '2-day training intervention, consisting of lectures, role-playing with SPs and group debriefing']","['quality of PrEP counselling', 'quality of PrEP counselling, including adherence to national guidelines and communication skills, scored on a checklist']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0035822', 'cui_str': 'Role play technique'}, {'cui': 'C0085292', 'cui_str': 'Stiff-man syndrome'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",24.0,0.17426,Judgemental interactions with healthcare workers (HCW) and inadequate counselling can be barriers to PrEP use among AGYW.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Larsen', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA annalar@uw.edu.'}, {'ForeName': 'Kate S', 'Initials': 'KS', 'LastName': 'Wilson', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kinuthia', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'John-Stewart', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Pintye', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Abuna', 'Affiliation': 'Research and Programs, Kenyatta National Hospital/University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Harison', 'Initials': 'H', 'LastName': 'Lagat', 'Affiliation': 'Research and Programs, Kenyatta National Hospital/University of Nairobi, Nairobi, Kenya.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Owens', 'Affiliation': 'Health Sciences Simulation & Clinical Skills Center, Howard University, Seattle, Washington, DC, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Kohler', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, University of Washington, Seattle, Washington, USA.'}]",BMJ open,['10.1136/bmjopen-2019-035689']
1309,32565477,Is virtual reality effective to teach prevention of surgical site infections in the operating room? study protocol for a randomised controlled multicentre trial entitled VIP Room study.,"INTRODUCTION


Some surgical site infections (SSI) could be prevented by following adequate infection prevention and control (IPC) measures. Poor compliance with IPC measures often occurs due to knowledge gaps and insufficient education of healthcare professionals. The education and training of SSI preventive measures does not usually take place in the operating room (OR), due to safety, and organisational and logistic issues. The proposed study aims to compare virtual reality (VR) as a tool for medical students to learn the SSI prevention measures and adequate behaviours (eg, limit movements…) in the OR, to conventional teaching.
METHODS AND ANALYSIS


This protocol describes a randomised controlled multicentre trial comparing an educational intervention based on VR simulation to routine education. This multicentre study will be performed in three universities: Grenoble Alpes University (France), Imperial College London (UK) and University of Heidelberg (Germany). Third-year medical students of each university will be randomised in two groups. The students randomised in the intervention group will follow VR teaching. The students randomised in the control group will follow a conventional education programme. Primary outcome will be the difference between scores obtained at the IPC exam at the end of the year between the two groups. The written exam will be the same in the three countries. Secondary outcomes will be satisfaction and students' progression for the VR group. The data will be analysed with intention-to-treat and per protocol.
ETHICS AND DISSEMINATION


This study has been approved by the Medical Education Ethics Committee of the London Imperial College (MEEC1920-172), by the Ethical Committee for the Research of Grenoble Alpes University (CER Grenoble Alpes-Avis-2019-099-24-2) and by the Ethics Committee of the Medical Faculty of Heidelberg University (S-765/2019). Results will be published in peer-reviewed medical journals, communicated to participants, general public and all relevant stakeholders.",2020,Primary outcome will be the difference between scores obtained at the IPC exam at the end of the year between the two groups.,"['Grenoble Alpes University (France), Imperial College London (UK) and University of Heidelberg (Germany', 'medical students', 'three universities', 'Third-year medical students of each university']","['conventional education programme', 'educational intervention based on VR simulation to routine education', 'virtual reality (VR']","[""satisfaction and students' progression""]","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.0677448,Primary outcome will be the difference between scores obtained at the IPC exam at the end of the year between the two groups.,"[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Masson', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Birgand', 'Affiliation': 'Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, Imperial College, London, Greater London, United Kingdom.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Castro-Sánchez', 'Affiliation': 'Health Protection Research Unit in Healthcare Associated Infections and Antimicrobial Resistance, Imperial College, London, Greater London, United Kingdom.'}, {'ForeName': 'Vanessa Maria', 'Initials': 'VM', 'LastName': 'Eichel', 'Affiliation': 'Section for Hospital Hygiene and Environmental Health, Centre of Infectious Diseases, Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Comte', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Terrisse', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Brice', 'Initials': 'B', 'LastName': 'Rubens-Duval', 'Affiliation': 'Department of Orthopaedic Surgery and Sport Traumatology, Grenoble Alpes University Hospital, Grenoble, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Gillois', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Albaladejo', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Picard', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Jean Luc', 'Initials': 'JL', 'LastName': 'Bosson', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Nico Tom', 'Initials': 'NT', 'LastName': 'Mutters', 'Affiliation': 'Section for Hospital Hygiene and Environmental Health, Centre of Infectious Diseases, Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Landelle', 'Affiliation': 'TIMC-IMAG, CNRS, Grenoble INP, University Grenoble Alpes, Grenoble, France caroline.landelle@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2020-037299']
1310,32565480,Finnish study of intraoperative irrigation versus drain alone after evacuation of chronic subdural haematoma (FINISH): a study protocol for a multicentre randomised controlled trial.,"INTRODUCTION


Chronic subdural haematomas (CSDHs) are one of the most common neurosurgical conditions. The goal of surgery is to alleviate symptoms and minimise the risk of symptomatic recurrences. In the past, reoperation rates as high as 20%-30% were described for CSDH recurrences. However, following the introduction of subdural drainage, reoperation rates dropped to approximately 10%. The standard surgical technique includes burr-hole craniostomy, followed by intraoperative irrigation and placement of subdural drainage. Yet, the role of intraoperative irrigation has not been established. If there is no difference in recurrence rates between intraoperative irrigation and no irrigation, CSDH surgery could be carried out faster and more safely by omitting the step of irrigation. The aim of this multicentre randomised controlled trial is to study whether no intraoperative irrigation and subdural drainage results in non-inferior outcome compared with intraoperative irrigation and subdural drainage following burr-hole craniostomy of CSDH.
METHODS AND ANALYSIS


This is a prospective, randomised, controlled, parallel group, non-inferiority multicentre trial comparing single burr-hole evacuation of CSDH with intraoperative irrigation and evacuation of CSDH without irrigation. In both groups, a passive subdural drain is used for 48 hours as a standard of treatment. The primary outcome is symptomatic CSDH recurrence requiring reoperation within 6 months. The predefined non-inferiority margin for the primary outcome is 7.5%. To achieve a 2.5% level of significance and 80% power, we will randomise 270 patients per group. Secondary outcomes include modified Rankin Scale, rate of mortality, duration of operation, length of hospital stay, adverse events and change in volume of CSDH.
ETHICS AND DISSEMINATION


The study was approved by the institutional review board of the Helsinki and Uusimaa Hospital District (HUS/3035/2019 §238) and duly registered at ClinicalTrials.gov. We will disseminate the findings of this study through peer-reviewed publications and conference presentations.
TRIAL REGISTRATION NUMBER


NCT04203550.",2020,"Secondary outcomes include modified Rankin Scale, rate of mortality, duration of operation, length of hospital stay, adverse events and change in volume of CSDH.
",['after evacuation of chronic subdural haematoma (FINISH'],"['CSDH with intraoperative irrigation and evacuation of CSDH without irrigation', 'intraoperative irrigation versus drain alone', 'intraoperative irrigation and subdural drainage']","['modified Rankin Scale, rate of mortality, duration of operation, length of hospital stay, adverse events and change in volume of CSDH', 'reoperation rates', 'recurrence rates', 'symptomatic CSDH recurrence requiring reoperation']","[{'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}, {'cui': 'C1706059', 'cui_str': 'Finish'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0038541', 'cui_str': 'Subdural space structure'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]",,0.264025,"Secondary outcomes include modified Rankin Scale, rate of mortality, duration of operation, length of hospital stay, adverse events and change in volume of CSDH.
","[{'ForeName': 'Pihla', 'Initials': 'P', 'LastName': 'Tommiska', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Raj', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland rahul.raj@helsinki.fi.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schwartz', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Riku', 'Initials': 'R', 'LastName': 'Kivisaari', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Luostarinen', 'Affiliation': 'Division of Anaesthesiology, Department of Anaesthesiology, Intensive Care and Pain Medicine, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Jarno', 'Initials': 'J', 'LastName': 'Satopää', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}, {'ForeName': 'Simo', 'Initials': 'S', 'LastName': 'Taimela', 'Affiliation': 'Finland and Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Teppo', 'Initials': 'T', 'LastName': 'Järvinen', 'Affiliation': 'Finland and Finnish Centre for Evidence-Based Orthopedics (FICEBO), University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Ranstam', 'Affiliation': 'Clinical Sciences, Lunds Universitet, Lund, Sweden.'}, {'ForeName': 'Janek', 'Initials': 'J', 'LastName': 'Frantzen', 'Affiliation': 'Division of Clinical Neurosciences, Department of Neurosurgery and Turku Brain Centre, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Posti', 'Affiliation': 'Division of Clinical Neurosciences, Department of Neurosurgery and Turku Brain Centre, Turku University Hospital and University of Turku, Turku, Finland.'}, {'ForeName': 'Teemu M', 'Initials': 'TM', 'LastName': 'Luoto', 'Affiliation': 'Department of Neurosurgery, Tampere University Hospital and Tampere University, Tampere, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Leinonen', 'Affiliation': 'Department of Neurosurgery, Kuopio University Hospital and University of Eastern Finland, Kuopio, Pohjois-Savo, Finland.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Tetri', 'Affiliation': 'Unit of Clinical Neuroscience, Neurosurgery, University of Oulu and Medical Research Center, Oulu, Finland.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Koivisto', 'Affiliation': 'Department of Neurosurgery, Kuopio University Hospital and University of Eastern Finland, Kuopio, Pohjois-Savo, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Lönnrot', 'Affiliation': 'Department of Neurosurgery, University of Helsinki and Helsinki University Hospital, Helsinki, Uusimaa, Finland.'}]",BMJ open,['10.1136/bmjopen-2020-038275']
1311,32565482,Health impacts of seated arm ergometry training in patients with a diabetic foot ulcer: protocol for a randomised controlled trial.,"INTRODUCTION


Once diagnosed with a diabetic foot ulcer (DFU), patients are advised to offload, keeping pressure off the foot in order to facilitate ulcer healing. An increase in offloading is often accompanied by reductions in physical activity which can worsen the overall health of patients.While unable to perform traditional forms of upright activity, one mode of exercise that would allow patients to be physically active while adhering to offloading instruction is seated arm ergometry. The merits of tailored aerobic exercise in DFU remain unexplored.
METHODS AND ANALYSIS


This is a prospective open-label randomised controlled trial. Participants will be randomised to one of two groups, an exercise intervention group or control. The intervention group are required to undertake arm ergometry training at a moderate intensity (65%-75% HRpeak), three times per week for 12 weeks as individually prescribed by an exercise physiologist, while the control group will continue to receive standard care alone. Assessment of outcome measures will occur at baseline and after the intervention period, these will include: a seated VO 2  peak test, a blood sample, a short physical performance battery, a dual-energy X-ray absorptiometry scan and completing a range of health-based questionnaires. The above will be used to determine: cardiorespiratory fitness, metabolic health, physical function, body composition and quality of life, respectively. Ulcer area will also be measured as an approximate marker of ulcer healing.
ETHICS AND DISSEMINATION


This trial has been approved by 'Yorkshire & The Humber-Leeds West Research Ethics Committee' (19/YH/0269). Trial results will be published in peer-reviewed journals and through conference presentations.
TRIAL REGISTRATION NUMBER


ISRCTN16000053. Registered in accordance with WHO Trial Registration Data Set (version 1.3.1).",2020,"The above will be used to determine: cardiorespiratory fitness, metabolic health, physical function, body composition and quality of life, respectively.",['patients with a diabetic foot ulcer'],"['seated arm ergometry training', 'exercise intervention group or control', 'undertake arm ergometry training', 'standard care alone', 'tailored aerobic exercise']","['cardiorespiratory fitness, metabolic health, physical function, body composition and quality of life', 'seated VO 2  peak test, a blood sample, a short physical performance battery, a dual-energy X-ray absorptiometry scan and completing a range of health-based questionnaires']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]","[{'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.117669,"The above will be used to determine: cardiorespiratory fitness, metabolic health, physical function, body composition and quality of life, respectively.","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'McCarthy', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK mm636@le.ac.uk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yates', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Webb', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Game', 'Affiliation': 'Department of Diabetes and Endocrinology, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Melanie J', 'Initials': 'MJ', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}]",BMJ open,['10.1136/bmjopen-2020-039062']
1312,32573159,[Zheng's massage combined with electroacupuncture in the treatment of reflex sympathetic dystrophy syndrome of the wrist].,"OBJECTIVE


To observe the clinical effects of zheng's massage combined with electroacupuncture in the treatment ofreflex sensory dystrophy syndrome of the wrist.
METHODS


From October 2016 to September 2018, 48 cases of reflex sensory dystrophy syndrome of the wrist were divided into the observation group and the control group. In the observation group, there were 24 cases, including 10 males and 14 females, ranging in age from 54 to 76 years old, with an average age of (61.41 ±7.90) years old. The patients in the observation group were treated with  Zheng's  massage combined with electroacupuncture. The control group consisted of 24 patients, including 9 males and 15 females, ranging in age from 52 to 75 years old, with an averageage of (58.71±8.11 ) years old. The patients in the control group were treated with electroacupuncture alone. All the patients in both groups were treated for 6 weeks. The clinical symptoms and signs, visual anglogue scale (VAS), Cooney wrist score and clinical efficacy evaluation were compared between the two groups before and after treatment, and statistical analysis was conducted.
RESULTS


After 6 weeks of treatment, VAS in the control group was 4.9±1.8, and Cooney wrist score was 74.63±1.72; VAS in the observation group was 2.2±1.4, and Cooney wrist score was 86.31±2.53. The comprehensive scores of VAS and Cooney wrist joint between two groups were improved after treatment, and the observation group was better than control group( P <0.05). The curative effect of the observation group was better than that of the control group.
CONCLUSION


Zheng's massage combined with electroacupuncture has the following advantages in the treatment of reflex sympathetic dystrophy syndrome of the wrist, such as small trauma, patients' willingness promoting functional rehabilitation, which is worthy of clinical promotion.",2020,"The curative effect of the observation group was better than that of the control group.
","['reflex sympathetic dystrophy syndrome of the wrist', '24 cases, including 10 males and 14 females, ranging in age from 54 to 76 years old, with an average age of (61.41 ±7.90) years old', '24 patients, including 9 males and 15 females, ranging in age from 52 to 75 years old, with an averageage of (58.71±8.11 ) years old', 'From October 2016 to September 2018, 48 cases of reflex sensory dystrophy syndrome of the wrist']","['electroacupuncture alone', 'electroacupuncture', ""Zheng's  massage combined with electroacupuncture""]","['clinical symptoms and signs, visual anglogue scale (VAS), Cooney wrist score and clinical efficacy evaluation', 'Cooney wrist score', 'comprehensive scores of VAS and Cooney wrist joint', 'curative effect']","[{'cui': 'C0034931', 'cui_str': 'Complex regional pain syndrome type I'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0026850', 'cui_str': 'Muscular dystrophy'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1322271', 'cui_str': 'Wrist joint structure'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0173629,"The curative effect of the observation group was better than that of the control group.
","[{'ForeName': 'Hao-Chen', 'Initials': 'HC', 'LastName': 'Tang', 'Affiliation': 'Department of Traumatology, Sichuan Orthopedics Hospital, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Liu-Gang', 'Initials': 'LG', 'LastName': 'Tang', 'Affiliation': 'Department of Traumatology, Sichuan Orthopedics Hospital, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Yuan-Dong', 'Initials': 'YD', 'LastName': 'Cheng', 'Affiliation': 'Department of Traumatology, Sichuan Orthopedics Hospital, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Tai', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Department of Traumatology, Sichuan Orthopedics Hospital, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Biao', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Traumatology, Sichuan Orthopedics Hospital, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Traumatology, Sichuan Orthopedics Hospital, Chengdu 610041, Sichuan, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.06.010']
1313,32573161,[A case-control study of unicompartmental knee arthroplasty with mobile and fixed platform for the treatment of single compartment osteoarthritis of knee].,"OBJECTIVE


To compare and analyze the early clinical outcomes of unicompartmental knee arthroplasty with mobile and fixed platform for the treatment of single compartment osteoarthritis of knee.
METHODS


From January 2013 to December 2014, 86 cases (92 knees) of knee osteoarthritis with single compartment (medial) were randomly divided into two groups. One group consisted of 42 patients, including 18 males and 24 females, underwent unicompartmental knee arthroplasty with fixed platform prosthesis; the other group consisted of 44 patients, including 20 males and 24 females, underwent unicompartmental knee arthroplasty with mobile platform prosthesis. The surgery was performed by the same group of doctors. The operation time, blood loss, ROM, KSS and HSS scores of knee joint before and after surgery were recorded and the clinical follow up was completed.
RESULTS


The follow-up duration of the two groups ranged from 8 to 26 months, with an average of (18.20± 4.23) months. During the follow-up period, the periprosthetic fracture was found in 1 patient in the fixed platform group 1 year after operation, and polyethylene liner dislocation was found in 1 patient in the mobile platform group. No complications such as poor wound healing, periprosthetic infection or sterile prothesis loosening were found in all cases. In the fixed platform group, the operation time was (90.05±6.59) minutes and the blood loss was (53.76±6.04) ml. In the mobile platform group, the operation time was (90.73±6.74) minutes and the blood loss was (54.34±6.27) ml. In the fixed platform group, the ROM of knee increased from preoperative (94.52±4.54) degree to postoperative (104.64±4.42) degree. In the mobile platform group, the ROM of knee increased from preoperative (95.05±4.87) degree to postoperative (105.07±4.33) degree. In the fixed platform group, the KSS score increased from preoperative 48.69±5.68 to postoperative 83.55±5.37. In the mobile platform group, the KSS score increased from preoperative 49.39±5.68 to postoperative 84.11±6.14. In the fixed platform group, the HSS score increased from preoperative 45.45±3.62 to postoperative 84.55±6.08. In the mobile platform group, the HSS score increased from preoperative 45.93±4.01 to postoperative 85.16±6.30. There was no significant difference between the two groups.
CONCLUSION


There is no significant difference in the early outcome of unicondylar prosthesis with fixed and mobile platforms in the treatment of single compartmental osteoarthritis of knee. The long-term complications and revision rates of the two prostheses need further multi center and large-sample clinical study.",2020,"No complications such as poor wound healing, periprosthetic infection or sterile prothesis loosening were found in all cases.","['From January 2013 to December 2014, 86 cases (92 knees) of knee osteoarthritis with single compartment (medial', '42 patients, including 18 males and 24 females, underwent', '44 patients, including 20 males and 24 females, underwent', 'single compartment osteoarthritis of knee']","['unicompartmental knee arthroplasty with mobile platform prosthesis', 'unicompartmental knee arthroplasty with fixed platform prosthesis', 'unicompartmental knee arthroplasty with mobile and fixed platform']","['wound healing, periprosthetic infection or sterile prothesis loosening', 'ROM of knee', 'HSS score', 'operation time, blood loss, ROM, KSS and HSS scores of knee joint', 'KSS score', 'periprosthetic fracture', 'operation time', 'blood loss']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0018522', 'cui_str': 'Hallermann-Streiff syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0022541', 'cui_str': 'Kearns-Sayre syndrome'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C2609162', 'cui_str': 'Periprosthetic fracture'}]",,0.0206297,"No complications such as poor wound healing, periprosthetic infection or sterile prothesis loosening were found in all cases.","[{'ForeName': 'Li-Jun', 'Initials': 'LJ', 'LastName': 'Wei', 'Affiliation': ""Department of Joint Surgery, Guang' an Hospital of Zhoushan, Zhoushan 316102, Zhejiang, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': ""Department of Joint Surgery, Guang' an Hospital of Zhoushan, Zhoushan 316102, Zhejiang, China.""}, {'ForeName': 'Guan-Jun', 'Initials': 'GJ', 'LastName': 'Yi', 'Affiliation': ""Department of Joint Surgery, Guang' an Hospital of Zhoushan, Zhoushan 316102, Zhejiang, China.""}, {'ForeName': 'Chong-Xi', 'Initials': 'CX', 'LastName': 'Chai', 'Affiliation': ""Department of Joint Surgery, Guang' an Hospital of Zhoushan, Zhoushan 316102, Zhejiang, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Department of Joint Surgery, Guang' an Hospital of Zhoushan, Zhoushan 316102, Zhejiang, China.""}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.06.012']
1314,32569284,A biofeedback-enhanced therapeutic exercise video game intervention for young people with cerebral palsy: A randomized single-case experimental design feasibility study.,"IMPORTANCE/BACKGROUND


Movement-controlled video games have potential to promote home-based practice of therapy activities. The success of therapy gaming interventions depends on the quality of the technology used and the presence of effective support structures.
AIM


This study assesses the feasibility of a novel intervention that combines a co-created gaming technology integrating evidence-based biofeedback and solution-focused coaching (SFC) strategies to support therapy engagement and efficacy at home.
METHODS


Following feasibility and single-case reporting standards (CONSORT and SCRIBE), this was a non-blind, randomized, multiple-baseline, AB, design. Nineteen (19) young people with cerebral palsy (8-18 years old) completed the 4-week home-based intervention in France and Canada. Participant motivations, personalized practice goals, and relevance of the intervention to daily activities were discussed in a Solution Focused Coaching-style conversation pre-, post-intervention and during weekly check-ins. Participants controlled a video game by completing therapeutic gestures (wrist extension, pinching) detected via electromyography and inertial sensors on the forearm (Myo Armband and custom software). Process feasibility success criteria for recruitment response, completion and adherence rates, and frequency of technical issues were established a priori. Scientific feasibility, effect size estimates and variance were determined for Body Function outcome measures: active wrist extension, grip strength and Box and Blocks Test; and for Activities and Participation measures: Assisting Hand Assessment (AHA), Canadian Occupational Performance Measure (COPM) and Self-Reported Experiences of Activity Settings (SEAS).
RESULTS


Recruitment response (31%) and assessment completion (84%) rates were good and 74% of participants reached self-identified practice goals. As 17% of technical issues required external support to resolve, the intervention was graded as feasible with modifications. No adverse events were reported. Moderate effects were observed in Body Function measures (active wrist extension: SMD = 1.82, 95%CI = 0.85-2.78; Grip Strength: SMD = 0.63, 95%CI = 0.65-1.91; Box and Blocks: Hedge's g = 0.58, 95%CI = -0.11-1.27) and small-moderate effects in Activities and Participation measures (AHA: Hedge's g = 0.29, 95%CI = -0.39-0.97, COPM: r = 0.60, 95%CI = 0.13-0.82, SEAS: r = 0.24, 95%CI = -0.25-0.61).
CONCLUSION


A definitive RCT to investigate the effectiveness of this novel intervention is warranted. Combining SFC-style coaching with high-quality biofeedback may positively engage youth in home rehabilitation to complement traditional therapy.
TRIAL REGISTRATION


ClinicalTrials.gov, U.S. National Library of Medicine: NCT03677193.",2020,"Participants controlled a video game by completing therapeutic gestures (wrist extension, pinching) detected via electromyography and inertial sensors on the forearm (Myo Armband and custom software).","['Nineteen (19) young people with cerebral palsy (8-18 years old', 'young people with cerebral palsy']","['novel intervention that combines a co-created gaming technology integrating evidence-based biofeedback and solution-focused coaching (SFC', 'single-case reporting standards (CONSORT and SCRIBE', 'biofeedback-enhanced therapeutic exercise video game intervention', 'SFC-style coaching with high-quality biofeedback', '4-week home-based intervention in France and Canada', 'video game by completing therapeutic gestures (wrist extension, pinching) detected via electromyography and inertial sensors on the forearm (Myo Armband and custom software']","['adverse events', 'Body Function measures', 'Body Function outcome measures: active wrist extension, grip strength and Box and Blocks Test; and for Activities and Participation measures: Assisting Hand Assessment (AHA), Canadian Occupational Performance Measure (COPM) and Self-Reported Experiences of Activity Settings (SEAS']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C1301852', 'cui_str': 'Armband'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",,0.0932629,"Participants controlled a video game by completing therapeutic gestures (wrist extension, pinching) detected via electromyography and inertial sensors on the forearm (Myo Armband and custom software).","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'MacIntosh', 'Affiliation': 'Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Desailly', 'Affiliation': 'Recherche et innovation, Fondation Ellen Poidatz, Saint Fargeau-Ponthierry, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Vignais', 'Affiliation': 'Complexité, Innovation, Activités Motrices et Sportives, Sciences du Sport, de la Motricité et du Mouvement Humain, Université Paris-Saclay, Orsay, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vigneron', 'Affiliation': ""Informatique, Bio-informatique et Systèmes Complexes, l'Université d'Evry Val-d'Essonne, Evry, France.""}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Biddiss', 'Affiliation': 'Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada.'}]",PloS one,['10.1371/journal.pone.0234767']
1315,32570152,To study the changes in maternal hemodynamics with intravenous labetalol or nifedipine in acute severe hypertension.,"OBJECTIVE


To study the maternal hemodynamic changes in acute severe hypertension after treatment with intravenous labetalol or oral nifedipine using color doppler ultrasound.
STUDY DESIGN


We evaluated thirty pregnant women with gestational age between 28 and 40 weeks in acute severe hypertension (more than or equal to 160/105 mmHg) which were randomly allocated to receive either intravenous labetalol or oral nifedipine until blood pressure was lowered to less than or equal to 140/90 mmHg. Doppler vascular indices namely pulsatility index, resistance index, S/D ratio of bilateral uterine arteries and maternal renal artery were measured baseline at the time of acute severe hypertension and repeated after control of blood pressure, to assess the changes in maternal hemodynamics if any with labetalol or nifedipine.
RESULTS


When evaluating right uterine artery Doppler parameters, a trend to increase in PI and RI was observed in those who received labetalol and nifedipine however the difference was not statistically significant. Whereas, while evaluating left uterine artery indices a trend to decrease PI was seen in nifedipine group but the difference was not statistically significant. On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group.
CONCLUSION


The use of labetalol and nifedipine were not related to any significant changes in maternal Doppler, which is reassuring about the safety of these drugs when treating acute severe hypertension in pregnancy.",2020,"On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group.
","['thirty pregnant women with gestational age between 28 and 40\xa0weeks in acute severe hypertension (more than or equal to 160/105\xa0mmHg', 'acute severe hypertension', 'acute severe hypertension after treatment with intravenous']","['labetalol or nifedipine', 'nifedipine', 'labetalol or oral nifedipine', 'intravenous labetalol or oral nifedipine', 'labetalol and nifedipine', 'labetalol']","['renal artery indices', 'Doppler vascular indices namely pulsatility index, resistance index, S/D ratio of bilateral uterine arteries and maternal renal artery', 'PI and RI']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0035065', 'cui_str': 'Structure of renal artery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",30.0,0.0341283,"On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group.
","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Thakur', 'Affiliation': 'Department of Obstetrics & Gynaecology, YSPGMC, Nahan, India. Electronic address: thakurmonika126@gmail.com.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Gainder', 'Affiliation': 'Department of Obstetrics & Gynaecology, PGIMER, Chandigarh, India.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Saha', 'Affiliation': 'Department of Obstetrics & Gynaecology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Prakash', 'Affiliation': 'Department of Radiodiagnosis, PGIMER, Chandigarh, India.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.014']
1316,32574761,HAWK and HARRIER: Ninety-Six-Week Outcomes from the Phase 3 Trials of Brolucizumab for Neovascular Age-Related Macular Degeneration.,"PURPOSE


To report the 96-week outcomes from HAWK and HARRIER.
DESIGN


Phase 3, prospective, randomized, double-masked, multicenter studies comparing efficacy and safety of brolucizumab 3 mg (HAWK only) and 6 mg with aflibercept 2 mg in eyes with neovascular age-related macular degeneration (nAMD).
PARTICIPANTS


Treatment-naïve eyes with nAMD were randomized 1:1:1 to brolucizumab 3 mg (n = 358), brolucizumab 6 mg (n = 360), aflibercept 2 mg (n = 360; HAWK) or 1:1 to brolucizumab 6 mg (n = 370), aflibercept 2 mg (n = 369; HARRIER).
METHODS


After 3 monthly loading doses, brolucizumab patients received every (q)-12-week (w) dosing, possibly adjusting to q8w dosing if disease activity was present at predefined disease activity assessment (DAA) visits. Aflibercept was dosed in a fixed q8w regimen. Visual and anatomic parameters were assessed throughout. Primary end point was at week 48 (48w), confirmed at 96w.
MAIN OUTCOME MEASURES


Mean best-corrected visual acuity (BCVA) change from baseline, proportion of patients on an q12w regimen, retinal thickness, retinal fluid changes, and safety, all 96w.
RESULTS


Mean change (least squares [LS] mean ± standard error) in BCVA from baseline to 96w in HAWK was 5.6±0.79 Early Treatment Diabetic Retinopathy Study (ETDRS) letters for brolucizumab 3 mg, 5.90±0.78 letters for brolucizumab 6 mg, and 5.3±0.78 letters for aflibercept and in HARRIER was 6.1±0.73 letters for brolucizumab 6 mg and 6.6 ± 0.73 letters for aflibercept. Greater central subfield thickness reductions were observed with brolucizumab 6 mg versus aflibercept in HAWK (LS mean, -174.8 μm vs. -148.7 μm; 95% confidence interval for treatment difference, -46.2 to -5.9 μm; P = 0.0115) and HARRIER (LS mean, -197.7 μm vs. -155.1 μm; 95% confidence interval for treatment difference, -62.0 to -23.3 μm; P < 0.0001). The proportions of eyes with intraretinal fluid and/or subretinal fluid (IRF/SRF) 96w in HAWK were 31% (P = 0.0688) and 24% (P = 0.0002) for brolucizumab 3 mg and 6 mg and 37% for aflibercept, whereas in HARRIER, they were 24% for brolucizumab 6 mg (P < 0.0001) and 39% for aflibercept. At 92w (last DAA), a 45.4% and 38.6% probability was observed for brolucizumab 6 mg patients of maintaining an q12w treatment regimen in HAWK and HARRIER, respectively. Brolucizumab exhibited an overall well-tolerated safety profile.
CONCLUSIONS


Visual outcomes from 48w to 96w confirm the efficacy achieved at 48w. Brolucizumab demonstrated greater fluid resolution compared with aflibercept. The q12w potential for brolucizumab observed at 48w was maintained to 96w.",2020,"Greater central subfield thickness (CST) reductions were observed with brolucizumab 6mg vs aflibercept in HAWK (LS mean; -174.8 vs -148.7 μm; 95% CI for treatment difference -46.2, -5.9; p=0.0115) and HARRIER (LS mean; -197.7 vs -155.1 μm; 95% CI for treatment difference, -62.0, -23.3; p<0.0001).","['neovascular age-related macular degeneration', 'eyes with neovascular AMD (nAMD) PARTICIPANTS: Treatment naive eyes with nAMD']","['brolucizumab 3mg', 'aflibercept', 'Aflibercept', 'brolucizumab', 'brolucizumab 6mg (n=370) or aflibercept 2mg (n=369) [HARRIER', 'HAWK and HARRIER', 'Brolucizumab', 'brolucizumab 6mg (n=360) or aflibercept 2mg (n=360) [HAWK']","['Visual and anatomical parameters', 'proportion of eyes with intraretinal fluid and/or subretinal fluid (IRF/SRF', 'Mean change (LS mean ±SE) in BCVA (ETDRS letters', 'efficacy and safety', 'overall well-tolerated safety profile', 'Greater central subfield thickness (CST) reductions', 'Mean best corrected visual acuity (BCVA) change from baseline, proportion of patients on q12w, retinal thickness, retinal fluid changes, and safety', 'fluid resolution']","[{'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0017921', 'cui_str': 'Generalized glycogenosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4550124', 'cui_str': 'brolucizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0324380', 'cui_str': 'Harrier dog'}, {'cui': 'C0325553', 'cui_str': 'Hawk'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C4531067', 'cui_str': 'Intraretinal fluid'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0063613', 'cui_str': 'insulin resistance factor (uremia)'}, {'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}]",,0.0754469,"Greater central subfield thickness (CST) reductions were observed with brolucizumab 6mg vs aflibercept in HAWK (LS mean; -174.8 vs -148.7 μm; 95% CI for treatment difference -46.2, -5.9; p=0.0115) and HARRIER (LS mean; -197.7 vs -155.1 μm; 95% CI for treatment difference, -62.0, -23.3; p<0.0001).","[{'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, Arizona. Electronic address: pdugel@gmail.com.'}, {'ForeName': 'Rishi P', 'Initials': 'RP', 'LastName': 'Singh', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Koh', 'Affiliation': 'Eye & Retina Surgeons, Singapore, Republic of Singapore.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Ogura', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Weissgerber', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Kinfemichael', 'Initials': 'K', 'LastName': 'Gedif', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Jaffe', 'Affiliation': 'Duke Eye Center, Durham, North Carolina.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Tadayoni', 'Affiliation': 'Lariboisiere & Saint Louis Hospitals, Universite de Paris, Paris, France.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Schmidt-Erfurth', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Holz', 'Affiliation': 'University of Bonn, Bonn, Germany.'}]",Ophthalmology,['10.1016/j.ophtha.2020.06.028']
1317,32574801,Emotion generation and regulation following an intrusion induction: Implications for taboo or autogenous obsessions.,"BACKGROUND AND OBJECTIVES


Research demonstrates that autogenous (AO) and reactive obsessions (RO) differ in obsessional content; however, no experimental research has examined differences in emotion generation and regulation. Characterizing this taxonomy with respect to emotion generation and regulation could refine conceptualizations of obsessionality and optimize clinical interventions.
METHODS


Seventy undergraduates were randomly assigned to imagine a personally-relevant AO or RO. Subsequently, emotional reactivity was assessed. Participants then rated their emotion regulation efforts and the degree to which the intrusion violated their values.
RESULTS


Broadly aligning with expectations, bootstrapped linear regression models indicated that AOs led to a significant increase in self-conscious emotions (guilt, shame, and embarrassment), and these effects were stronger for those whose values were more severely threatened by the intrusion. A conditional process analysis revealed that the relationship between the AO condition and emotion regulation difficulties was explained by an increase in negative emotional reactivity, and the strength of this effect depended upon the degree of conflict with participants' values.
LIMITATIONS


The use of an analogue sample, and minimal emotional reactivity in the RO condition, threaten the ecological and external validity of the study.
CONCLUSIONS


The current study employed a novel experimental design demonstrating a meaningful relationship between AOs and both emotional activation and regulation. Results highlight the relevance of self-conscious emotions to the conceptualization of AOs and the utility of addressing them in the context of exposure therapy.",2020,"Broadly aligning with expectations, bootstrapped linear regression models indicated that AOs led to a significant increase in self-conscious emotions (guilt, shame, and embarrassment), and these effects were stronger for those whose values were more severely threatened by the intrusion.","['taboo or autogenous obsessions', 'Seventy undergraduates']",['imagine a personally-relevant AO or RO'],"['negative emotional reactivity', 'self-conscious emotions (guilt, shame, and embarrassment', 'AO condition and emotion regulation difficulties', 'emotional reactivity']","[{'cui': 'C0039227', 'cui_str': 'Taboo'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0679112', 'cui_str': 'Embarrassment'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",70.0,0.0314195,"Broadly aligning with expectations, bootstrapped linear regression models indicated that AOs led to a significant increase in self-conscious emotions (guilt, shame, and embarrassment), and these effects were stronger for those whose values were more severely threatened by the intrusion.","[{'ForeName': 'Noah Chase', 'Initials': 'NC', 'LastName': 'Berman', 'Affiliation': 'College of the Holy Cross, Department of Psychology, 1 College St, Worcester, MA, 01610, USA. Electronic address: nberman@holycross.edu.'}, {'ForeName': 'Jumi', 'Initials': 'J', 'LastName': 'Hayaki', 'Affiliation': 'College of the Holy Cross, Department of Psychology, 1 College St, Worcester, MA, 01610, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Szkutak', 'Affiliation': 'College of the Holy Cross, Department of Psychology, 1 College St, Worcester, MA, 01610, USA.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101593']
1318,32574844,"Effect of soluble corn fiber supplementation for 1 year on bone metabolism in children, the MetA-bone trial: Rationale and design.","Calcium intake is critical for adequate bone mineralization in adolescence, but it is usually inadequate in US adolescents. A strategy to maximize bone mineralization is to increase calcium absorption, which could be achieved by soluble corn fiber (SCF). There are no studies determining the long-term effects of SCF on bone mass in children.
OBJECTIVES


To determine the effect of one-year SCF supplementation compared to placebo on bone mass and bone biomarkers in children with low habitual calcium intake. We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
METHODS


240 healthy children (10-13 years), with usual low calcium intake, will be randomized to four experimental groups for 1 year: (1) SCF (12 g/d); (2) SCF (12 g/d) + 600 mg/d of calcium; (3) Placebo (maltodextrin); and (4) Placebo +600 mg/d of calcium. The supplements have been pre-mixed with a flavored powder beverage and participants will only need to dilute it in water and drink this twice per day. Bone will be measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 and 12 months. Serum bone biomarkers will be measured at baseline and at 12 months.
CONCLUSIONS


If supplementing diets with SCF lead to higher bone mass during adolescence, this could help achieve the genetic potential for PBM and to start adult life with stronger bones. If successful, SCF can be incorporated into diets for promoting bone health in adolescents.",2020,"We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
","['240 healthy children (10-13\u202fyears', 'adolescents', 'children with low habitual calcium intake', 'children']","['SCF', 'usual low calcium intake', 'soluble corn fiber supplementation', 'calcium; (3) Placebo (maltodextrin', 'Calcium intake', 'SCF supplementation', 'Placebo +600\u202fmg/d of calcium', 'placebo']","['bone metabolism', 'Serum bone biomarkers', 'bone mineral content and higher levels of bone formation and lower bone resorption biomarkers', 'bone mass and bone biomarkers']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}]","[{'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0860967', 'cui_str': 'Calcium low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",240.0,0.314368,"We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers.
","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America. Electronic address: cristina.palacios@fiu.edu.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Trak-Fellermeier', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Pérez', 'Affiliation': 'Department of Biostatistics and Epidemiology, Graduate School of Public Health, Medical Sciences Campus, University of Puerto Rico, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Huffman', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hernandez Suarez', 'Affiliation': 'Vice Provost for Population Health and Well-being, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Bursac', 'Affiliation': 'Department of Biostatistics, Robert Stempel College of Public Health, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Gambon', 'Affiliation': 'Pediatrician, Citrus Health Network, 551 W 51st Pl, Hialeah, FL 33012, United States of America.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Nakatsu', 'Affiliation': 'Department of Agronomy, College of Agriculture, Purdue University, 915 West State Street, West Lafayette, IN 47907-2053, United States of America.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Weaver', 'Affiliation': 'Distinguished Professor emerita, Purdue University, 610 Purdue Mall, West Lafayette, IN 47907, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106061']
1319,32583973,Trabecular bone deterioration in differentiated thyroid cancer: Impact of long-term TSH suppressive therapy.,"BACKGROUND


Conflicting results has been reported regard osteoporosis and fractures in patients with Differentiated Thyroid Cancer (DTC). Our objective was to evaluate the long-term effects of TSH suppression therapy with Levothyroxine (LT4) on trabecular bone score (TBS) and bone mineral density (BMD) in females with DTC after thyroidectomy.
METHODS


About 145 women with resected DTC and receiving long-term TSH therapy, were stratified according to the degree of TSH suppression. Mean duration of follow-up was 12.3 ± 6.1 years. BMD and TBS, were assessed using dual-energy X-ray absorptiometry (DXA) and TBS iNsight (Med-Imaps), at baseline (1-3 months after surgery) and at the final study visit.
RESULTS


In patients stratified by duration of TSH suppression therapy (Group I, 5-10 years; Group II, >10 years), slight increases from baseline TSH levels were observed. Significant decreases in LS-BMD and FN-BMD were seen in patients after >10 years. TBS values were lower in Groups I (1.289 ± 0.122) and II (1.259 ± 0.129) compared with baseline values (P = .0001, both groups). Regarding the degree of TSH suppression, TBS was significantly reduced in those with TSH < 0.1 µU/mL (P = .0086), and not in patients with TSH suppression of 0.1.-0.5 or >0.5 µU/mL.
CONCLUSIONS


We found deterioration of trabecular structure in patients with DTC and TSH suppression therapy below 0.1 µU/mL and after 5-10 years of follow-up. Significant changes in BMD according to TSH levels were not observed. Trabecular Bone Score is a useful technique for identifying thyroid cancer patients with risk of bone deterioration.",2020,"TBS values were lower in Groups I (1.289 ± 0.122) and II (1.259 ± 0.129) compared with baseline values (P = .0001, both groups).","['females with DTC after thyroidectomy', 'thyroid cancer patients with risk of bone deterioration', 'patients with Differentiated Thyroid Cancer (DTC', '145 women with resected DTC and receiving long-term TSH therapy', 'differentiated thyroid cancer']","['TSH suppression therapy', 'TSH suppression therapy with Levothyroxine (LT4', 'TSH suppressive therapy']","['trabecular bone score (TBS) and bone mineral density (BMD', 'LS-BMD and FN-BMD', 'TSH suppression, TBS', 'baseline TSH levels', 'BMD and TBS', 'Trabecular bone deterioration', 'TBS values', 'BMD according to TSH levels']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4722172', 'cui_str': 'Primary differentiated carcinoma of thyroid gland'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040165', 'cui_str': 'levothyroxine'}, {'cui': 'C0205367', 'cui_str': 'Suppressive'}]","[{'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0040160', 'cui_str': 'Thyrotropin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",145.0,0.0222858,"TBS values were lower in Groups I (1.289 ± 0.122) and II (1.259 ± 0.129) compared with baseline values (P = .0001, both groups).","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Hawkins Carranza', 'Affiliation': 'Research Institute i+12, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Sonsoles', 'Initials': 'S', 'LastName': 'Guadalix Iglesias', 'Affiliation': 'Thyroid Cancer Unit, Service of Endocrinology, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Luisa De Mingo Domínguez', 'Affiliation': 'Hospital La Luz, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martín-Arriscado Arroba', 'Affiliation': 'Epidemiology Unit, Research Institute i+12, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'López Álvarez', 'Affiliation': 'Centro de Salud Goya, Madrid, Spain.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Allo Miguel', 'Affiliation': 'Service of Endocrinology, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Martínez Díaz-Guerra', 'Affiliation': 'Service of Endocrinology, University Hospital 12 de Octubre, Madrid, Spain.'}]",Cancer medicine,['10.1002/cam4.3200']
1320,32469920,Actor feedback and rigorous monitoring: Essential quality assurance tools for testing behavioral interventions with simulation.,"INTRODUCTION


Simulation is a powerful tool for training and evaluating clinicians. However, few studies have examined the consistency of actor performances during simulation based medical education (SBME). The Simulated Communication with ICU Proxies trial (ClinicalTrials.gov NCT02721810) used simulation to evaluate the effect of a behavioral intervention on physician communication. The purpose of this secondary analysis of data generated by the quality assurance team during the trial was to assess how quality assurance monitoring procedures impacted rates of actor errors during simulations.
METHODS


The trial used rigorous quality assurance to train actors, evaluate performances, and ensure the intervention was delivered within a standardized environment. The quality assurance team evaluated video recordings and documented errors. Actors received both timely, formative feedback and participated in group feedback sessions.
RESULTS


Error rates varied significantly across three actors (H(2) = 8.22, p = 0.02). In adjusted analyses, there was a decrease in the incidence of actor error over time, and errors decreased sharply after the first group feedback session (Incidence Rate Ratio = 0.25, 95% confidence interval 0.14-0.42).
CONCLUSIONS


Rigorous quality assurance procedures may help ensure consistent actor performances during SBME.",2020,"In adjusted analyses, there was a decrease in the incidence of actor error over time, and errors decreased sharply after the first group feedback session (Incidence Rate Ratio = 0.25, 95% confidence interval 0.14-0.42).
",[],"['Actor feedback and rigorous monitoring', 'behavioral intervention']","['incidence of actor error over time, and errors', 'Error rates']",[],"[{'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0672195,"In adjusted analyses, there was a decrease in the incidence of actor error over time, and errors decreased sharply after the first group feedback session (Incidence Rate Ratio = 0.25, 95% confidence interval 0.14-0.42).
","[{'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Abshire', 'Affiliation': 'School of Nursing, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Pragyashree Sharma', 'Initials': 'PS', 'LastName': 'Basyal', 'Affiliation': 'Outcomes After Critical Illness and Surgery (OACIS) Group, Johns Hopkins University, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Teply', 'Affiliation': 'Division of Geriatrics, Gerontology, and Palliative Medicine, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, United States of America.'}, {'ForeName': 'Arun L', 'Initials': 'AL', 'LastName': 'Singh', 'Affiliation': ""Division of Pediatric Palliative Medicine, Prisma Health Children's Hopsital - Upstate, University of South Carolina School of Medicine - Greenville, Greenville, South Carolina, United States of America.""}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Hayes', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Alison E', 'Initials': 'AE', 'LastName': 'Turnbull', 'Affiliation': 'Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America.'}]",PloS one,['10.1371/journal.pone.0233538']
1321,32469922,The Community Navigator Study: Results from a feasibility randomised controlled trial of a programme to reduce loneliness for people with complex anxiety or depression.,"BACKGROUND


Loneliness is common among people with mental health problems and predicts poorer recovery from depression and anxiety. Needs for support with loneliness and social relationships are often under-addressed in mental health services. The Community Navigator programme was designed to reduce loneliness for adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services. Acceptability and feasibility of the programme and a trial evaluation were tested in a feasibility randomised controlled trial with qualitative evaluation.
METHODS


Forty participants with depression or anxiety using secondary mental health services were recruited from mental health services in two London sites and randomised to receive: the Community Navigator programme over six months in addition to routine care (n = 30); or routine care (n = 10). Measures of loneliness, depression, other clinical and social outcomes and service use were collected at baseline and six-months follow-up. Levels of engagement in the programme and rates of trial recruitment and retention were assessed. Programme delivery was assessed through session logs completed by Community Navigators. The acceptability of the programme was explored through qualitative interviews (n = 32) with intervention group participants, their family and friends, programme providers and other involved staff.
RESULTS


Forty participants were recruited in four months from 65 eligible potential participants asked. No one withdrew from the trial. Follow-up interviews were completed with 35 participants (88%). Process records indicated the programme was delivered as intended: there was a median of seven meetings with their Community Navigator (of a maximum ten) per treatment group participant. Qualitative interviews indicated good acceptability of the programme to stakeholders, and potential utility in reducing loneliness and depression and anxiety.
CONCLUSIONS


A definitive, multi-site randomised controlled trial is recommended to evaluate the effectiveness and cost-effectiveness of the Community Navigator programme for people with complex anxiety and depression in secondary mental health services.",2020,The Community Navigator programme was designed to reduce loneliness for adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services.,"['people with complex anxiety and depression in secondary mental health services', 'people with complex anxiety or depression', 'Forty participants were recruited in four months from 65 eligible potential participants asked', 'people with mental health problems', 'adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services', 'Forty participants with depression or anxiety using secondary mental health services were recruited from mental health services in two London sites and randomised to receive: the']","['Community Navigator programme over six months in addition to routine care (n = 30); or routine care', 'Community Navigator programme']","['Acceptability and feasibility', 'loneliness and depression and anxiety', 'effectiveness and cost-effectiveness', 'loneliness, depression, other clinical and social outcomes and service use']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",40.0,0.205116,The Community Navigator programme was designed to reduce loneliness for adults (aged 18 and above) with complex depression or anxiety who were using secondary mental health services.,"[{'ForeName': 'Brynmor', 'Initials': 'B', 'LastName': 'Lloyd-Evans', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Frerichs', 'Affiliation': 'The McPin Foundation, London, United Kingdom.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Stefanidou', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Pinfold', 'Affiliation': 'The McPin Foundation, London, United Kingdom.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Billings', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Barber', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Anjie', 'Initials': 'A', 'LastName': 'Chhapia', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Beverley', 'Initials': 'B', 'LastName': 'Chipp', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Henderson', 'Affiliation': 'Camden and Islington NHS Foundation Trust, St Pancras Hospital, London, United Kingdom.'}, {'ForeName': 'Prisha', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Shorten', 'Affiliation': 'Camden and Islington NHS Foundation Trust, St Pancras Hospital, London, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Giorgalli', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Terhune', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, London, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0233535']
1322,32469946,Training specificity performing single-joint vs. multi-joint resistance exercises among physically active females: A randomized controlled trial.,"Resistance-training of the lower limbs can be performed using exercises moving one (single-joint exercises) or several joints (multi-joint exercises). This study compared the effects of training one multi-joint exercise (leg press) or two single-joint exercises (leg extension and kickback) on dynamic and isometric strength and the transferability of dynamic strength between exercises. Fifty-three physically active women were randomized to a multi-joint (MJ) training group (age = 21.95±0.82 years, mass = 64.85±5.76 kg, height = 167.35±2.47 cm; n = 20), single-joint (SJ) training group (age = 22.56±1.66 years, mass = 64.85±5.76 kg, height = 165.94±2.84 cm; n = 18), or a control (CON) group (age = 21.27±0.68 years, mass = 68.43±4.86 kg, height = 168.63±2.84 cm; n = 15). The training groups participated in an 8-week supervised single- or multi-joint lower limb training consisting of 18 sessions. Pre- and post-training, six repetitions maximum (RM) and maximal voluntary isometric contraction in the three exercises were assessed, along with electromyography of the superficial quadriceps muscles. Improvements in all dynamic exercises were greatest after training the specific exercises (ES = 1.26-2.14, P<0.001-0.025) and all were greater in the training groups than in the CON group (ES = 1.43-3.31, P<0.001-0.021). The SJ group improved 6RM in leg extension and kickback more than leg press (ES = 1.51 and 2.04, respectively, P<0.001), whereas the MJ group improved leg press 6RM more than kickback (ES = 1.10, P = 0.002). However, leg press and leg extension strength improved similarly in the MJ group (ES = 0.54, P = 0.072). All strength and electromyographic measures remained unchanged in the CON group (ES = 0.00-0.44, P = 0.412-0.966). Improved dynamic strength in leg press, kickback and leg extension is best attained by training the specific exercises, but both training modalities can improve strength across all exercises.",2020,"The SJ group improved 6RM in leg extension and kickback more than leg press (ES = 1.51 and 2.04, respectively, P<0.001), whereas the MJ group improved leg press 6RM more than kickback (ES = 1.10, P = 0.002).","['group (age = 22.56±1.66 years, mass = 64.85±5.76 kg, height = 165.94±2.84 cm; n = 18), or a control (CON) group (age = 21.27±0.68 years, mass = 68.43±4.86 kg, height = 168.63±2.84 cm; n = 15', 'Fifty-three physically active women', 'group (age = 21.95±0.82 years, mass = 64.85±5.76 kg, height = 167.35±2.47 cm; n = 20', 'physically active females']","['multi-joint (MJ) training', 'Training specificity performing single-joint vs. multi-joint resistance exercises', 'Pre- and post-training, six repetitions maximum (RM) and maximal voluntary isometric contraction', 'single-joint (SJ) training', 'SJ', '8-week supervised single- or multi-joint lower limb training consisting of 18 sessions', 'training one multi-joint exercise (leg press) or two single-joint exercises (leg extension and kickback']","['6RM in leg extension and kickback', 'dynamic strength in leg press, kickback and leg extension', 'leg press 6RM', 'All strength and electromyographic measures', 'leg press and leg extension strength']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0556502', 'cui_str': 'Lower limb training'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0086504', 'cui_str': 'Kickbacks'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0086504', 'cui_str': 'Kickbacks'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",53.0,0.0304002,"The SJ group improved 6RM in leg extension and kickback more than leg press (ES = 1.51 and 2.04, respectively, P<0.001), whereas the MJ group improved leg press 6RM more than kickback (ES = 1.10, P = 0.002).","[{'ForeName': 'Nicolay', 'Initials': 'N', 'LastName': 'Stien', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Pedersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Aril Hagen', 'Initials': 'AH', 'LastName': 'Ravnøy', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Vidar', 'Initials': 'V', 'LastName': 'Andersen', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Atle Hole', 'Initials': 'AH', 'LastName': 'Saeterbakken', 'Affiliation': 'Faculty of Education, Arts and Sports, Western Norway University of Applied Sciences, Bergen, Norway.'}]",PloS one,['10.1371/journal.pone.0233540']
1323,32479786,"Neuroleptic strategies for terminal agitation in patients with cancer and delirium at an acute palliative care unit: a single-centre, double-blind, parallel-group, randomised trial.","BACKGROUND


The role of neuroleptics for terminal agitated delirium is controversial. We assessed the effect of three neuroleptic strategies on refractory agitation in patients with cancer with terminal delirium.
METHODS


In this single-centre, double-blind, parallel-group, randomised trial, patients with advanced cancer, aged at least 18 years, admitted to the palliative and supportive care unit at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), with refractory agitation, despite low-dose haloperidol, were randomly assigned to receive intravenous haloperidol dose escalation at 2 mg every 4 h, neuroleptic rotation with chlorpromazine at 25 mg every 4 h, or combined haloperidol at 1 mg and chlorpromazine at 12·5 mg every 4 h, until death or discharge. Rescue doses identical to the scheduled doses were administered at inception, and then hourly as needed. Permuted block randomisation (block size six; 1:1:1) was done, stratified by baseline Richmond Agitation Sedation Scale (RASS) scores. Research staff, clinicians, patients, and caregivers were masked to group assignment. The primary outcome was change in RASS score from time 0 to 24 h. Comparisons among group were done by modified intention-to-treat analysis. This completed study is registered with ClinicalTrials.gov, NCT03021486.
FINDINGS


Between July 5, 2017, and July 1, 2019, 998 patients were screened for eligibility, with 68 being enrolled and randomly assigned to treatment; 45 received the masked study interventions (escalation n=15, rotation n=16, combination n=14). RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3 [-4·4 to -2·2]), and combination group (n=10, -3·0 [-4·6 to -1·4]), with no difference among groups (p=0·71). The most common serious toxicity was hypotension (escalation n=6 [40%], rotation n=5 [31%], combination n=3 [21%]); there were no treatment-related deaths.
INTERPRETATION


Our data provide preliminary evidence that the three strategies of neuroleptics might reduce agitation in patients with terminal agitation. These findings are in the context of the single-centre design, small sample size, and lack of a placebo-only group.
FUNDING


National Institute of Nursing Research.",2020,"RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3","['patients with terminal agitation', 'patients with cancer and delirium at an acute palliative care unit', 'Between July 5, 2017, and July 1, 2019, 998 patients were screened for eligibility, with 68 being enrolled and randomly assigned to treatment; 45 received the masked study interventions (escalation n=15, rotation n=16, combination n=14', 'patients with cancer with terminal delirium', 'patients with advanced cancer, aged at least 18 years, admitted to the palliative and supportive care unit at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), with refractory agitation, despite low-dose']","['neuroleptic strategies', 'Neuroleptic strategies', 'haloperidol', 'intravenous haloperidol dose escalation at 2 mg every 4 h, neuroleptic rotation with chlorpromazine at 25 mg every 4 h, or combined haloperidol at 1\u2008mg and chlorpromazine']","['mean RASS score change', 'RASS score', 'Agitation Sedation Scale (RASS) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087165', 'cui_str': 'Terminal agitation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",998.0,0.653147,"RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hui', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: dhui@mdanderson.org.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'De La Rosa', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Marvin', 'Initials': 'M', 'LastName': 'Delgado-Guay', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Azhar', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Arthur', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Epner', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Haider', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'De La Cruz', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Heung', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kimberson', 'Initials': 'K', 'LastName': 'Tanco', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Dalal', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Akhila', 'Initials': 'A', 'LastName': 'Reddy', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Amin', 'Affiliation': 'Department of Investigational Pharmacy, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Terri S', 'Initials': 'TS', 'LastName': 'Armstrong', 'Affiliation': 'Neuro-Oncology Branch, Centre for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Breitbart', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30307-7']
1324,32577113,Automated Mobile Phone Messaging Utilizing a Cognitive Behavioral Intervention: A Pilot Investigation.,"Background


In the setting of outpatient orthopaedic surgery, this pilot study utilized automated mobile messaging to assess (1) the feasibility of and interaction rates with a software delivered cognitive behavior therapy (CBT) intervention for postoperative opioid utilization, (2) the reliability of patient reported opioid utilization through our platform, (3) daily patient reported pain and opioid utilization within the first two postoperative weeks, and (4) the effect of software delivered CBT intervention on patient reported opioid utilization.
Methods


Musculoskeletal tumor patients scheduled for outpatient surgery were randomized into two study groups. Control patients received standard postoperative communication limited to a two-week postoperative follow-up visit. The intervention group received automated daily text-messages regarding pain, opioid utilization, and a daily CBT intervention. Interventional group patients also completed a patient satisfaction questionnaire at their two-week follow-up. Completion rates of all software delivered questions were determined in the interventional group. Median values of opioid utilization and interquartile range (IQR) were determined to compare utilization between groups. Spearman correlation coefficients were used to determine reliability of patient reported opioid utilization in the interventional group.
Results


Fourteen patients completed the pilot study (seven controls, seven intervention). Patients in the intervention arm completed 90% of pain and opioid questions. Intervention group patients utilized less of their daily prescribed opioid medication (20%, IQR:10%-27%) compared to controls (50%, IQR:4%-68%). Correlation between in-office pill counts and patient reported opioid medication utilization via our software messaging system was high (r=0.90, p=0.037).
Conclusion


Automated mobile phone messaging in outpatient tumor surgery yielded high interaction rates. Patient reported opioid utilization obtained through our platform demonstrated a high correlation with in-office pill counts. CBT delivered via automated mobile phone messaging demonstrated decreased opioid utilization in this pilot investigation. Level of evidence: II .",2019,"Intervention group patients utilized less of their daily prescribed opioid medication (20%, IQR:10%-27%) compared to controls (50%, IQR:4%-68%).",['Methods\n\n\nMusculoskeletal tumor patients scheduled for outpatient surgery'],"['CBT delivered via automated mobile phone messaging', 'Automated Mobile Phone Messaging Utilizing a Cognitive Behavioral Intervention', 'automated daily text-messages regarding pain, opioid utilization, and a daily CBT intervention', 'CBT intervention', 'cognitive behavior therapy (CBT) intervention']","['opioid utilization', 'pain and opioid utilization', 'Median values of opioid utilization and interquartile range (IQR', 'daily prescribed opioid medication', 'opioid medication utilization', 'patient satisfaction questionnaire']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0693844,"Intervention group patients utilized less of their daily prescribed opioid medication (20%, IQR:10%-27%) compared to controls (50%, IQR:4%-68%).","[{'ForeName': 'Edward O', 'Initials': 'EO', 'LastName': 'Rojas', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Anthony', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Kain', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Glass', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Apurva S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""Division of Orthopaedics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Miller', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}]",The Iowa orthopaedic journal,[]
1325,32574181,It's how you say it: Systematic A/B testing of digital messaging cut hospital no-show rates.,"Failure to attend hospital appointments has a detrimental impact on care quality. Documented efforts to address this challenge have only modestly decreased no-show rates. Behavioral economics theory has suggested that more effective messages may lead to increased responsiveness. In complex, real-world settings, it has proven difficult to predict the optimal message composition. In this study, we aimed to systematically compare the effects of several pre-appointment message formats on no-show rates. We randomly assigned members from Clalit Health Services (CHS), the largest payer-provider healthcare organization in Israel, who had scheduled outpatient clinic appointments in 14 CHS hospitals, to one of nine groups. Each individual received a pre-appointment SMS text reminder five days before the appointment, which differed by group. No-show and advanced cancellation rates were compared between the eight alternative messages, with the previously used generic message serving as the control. There were 161,587 CHS members who received pre-appointment reminder messages who were included in this study. Five message frames significantly differed from the control group. Members who received a reminder designed to evoke emotional guilt had a no-show rates of 14.2%, compared with 21.1% in the control group (odds ratio [OR]: 0.69, 95% confidence interval [CI]: 0.67, 0.76), and an advanced cancellation rate of 26.3% compared with 17.2% in the control group (OR: 1.2, 95% CI: 1.19, 1.21). Four additional reminder formats demonstrated significantly improved impact on no-show rates, compared to the control, though not as effective as the best performing message format. Carefully selecting the narrative of pre-appointment SMS reminders can lead to a marked decrease in no-show rates. The process of a/b testing, selecting, and adopting optimal messages is a practical example of implementing the learning healthcare system paradigm, which could prevent up to one-third of the 352,000 annually unattended appointments in Israel.",2020,"Four additional reminder formats demonstrated significantly improved impact on no-show rates, compared to the control, though not as effective as the best performing message format.","['161,587 CHS members who received pre-appointment reminder messages who were included in this study']","['Clalit Health Services (CHS), the largest payer-provider healthcare organization in Israel, who had scheduled outpatient clinic appointments']","['advanced cancellation rates', 'advanced cancellation rate']","[{'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced'}]",,0.0627862,"Four additional reminder formats demonstrated significantly improved impact on no-show rates, compared to the control, though not as effective as the best performing message format.","[{'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Berliner Senderey', 'Affiliation': 'Clalit Research Institute, Clalit Health Services, Tel Aviv, Israel.'}, {'ForeName': 'Tamar', 'Initials': 'T', 'LastName': 'Kornitzer', 'Affiliation': 'Kayma Labs, kayma, Tel Aviv, Israel.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Lawrence', 'Affiliation': 'Clalit Research Institute, Clalit Health Services, Tel Aviv, Israel.'}, {'ForeName': 'Hilla', 'Initials': 'H', 'LastName': 'Zysman', 'Affiliation': 'Kayma Labs, kayma, Tel Aviv, Israel.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Hallak', 'Affiliation': 'Fuqua School of Business, Duke University, Durham, North Carolina, United States of America.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ariely', 'Affiliation': 'Kayma Labs, kayma, Tel Aviv, Israel.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Balicer', 'Affiliation': 'Clalit Research Institute, Clalit Health Services, Tel Aviv, Israel.'}]",PloS one,['10.1371/journal.pone.0234817']
1326,32574223,A randomized controlled trial of nitrate supplementation in well-trained middle and older-aged adults.,"PURPOSE


Nitrate (NO3-), through its conversion to nitrite (NO2-) and nitric oxide, has been shown to increase exercise tolerance in healthy younger adults and older diseased patients. Nitrate's effect in well-trained middle to older-aged adults has not been studied. Therefore, the purpose of this investigation was to examine the effects of a NO3- rich beverage on submaximal constant work rate exercise time in well-trained middle to older-aged adults.
METHODS


This was a randomized controlled cross-over trial with 15 well-trained middle to older-aged adults, 41-64 year-old, who received one of two treatments (NO3- rich beverage then placebo or placebo then NO3- rich beverage), after which an exercise test at 75 percent of the subject's maximal work rate was completed.
RESULTS


The NO3- rich beverage increased plasma NO3- and NO2- levels by 260 μM and 0.47 μM, respectively (p<0.001). Exercise time was not significantly different (p = 0.31) between the NO3- rich versus placebo conditions (1130±151 vs 1060±132 sec, respectively). Changes in exercise time between the two conditions ranged from a 55% improvement to a 40% decrease with the NO3- rich beverage. Oxygen consumption and rating of perceived exertion were not significantly different between the two conditions.
CONCLUSION


In middle to older-aged well-trained adults, NO3- supplementation has non-significant, albeit highly variable, effects on exercise tolerance. ClinicalTrials.gov Identifier: NCT03371966.",2020,Exercise time was not significantly different (p = 0.31) between the NO3- rich versus placebo conditions (,"['healthy younger adults and older diseased patients', 'well-trained middle to older-aged adults', 'well-trained middle and older-aged adults', ""then NO3- rich beverage), after which an exercise test at 75 percent of the subject's maximal work rate was completed"", '15 well-trained middle to older-aged adults, 41-64 year-old, who received one of two treatments']","['NO3- rich beverage then placebo or placebo', 'nitrate supplementation', 'NO3- rich beverage']","['exercise time', 'Exercise time', 'exercise tolerance', 'submaximal constant work rate exercise time', 'plasma NO3- and NO2- levels', 'Oxygen consumption and rating of perceived exertion']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",,0.426141,Exercise time was not significantly different (p = 0.31) between the NO3- rich versus placebo conditions (,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Berry', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Miller', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Kim-Shapiro', 'Affiliation': 'Physics Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Macie S', 'Initials': 'MS', 'LastName': 'Fletcher', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Caleb G', 'Initials': 'CG', 'LastName': 'Jones', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Zachary D', 'Initials': 'ZD', 'LastName': 'Gauthier', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Summer L', 'Initials': 'SL', 'LastName': 'Collins', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Physics Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Heinrich', 'Affiliation': 'Health and Exercise Department, Wake Forest University, Winston-Salem, North Carolina, United States of America.'}]",PloS one,['10.1371/journal.pone.0235047']
1327,32579971,When the camera eats first: Exploring how meal-time cell phone photography affects eating behaviours.,"Advances in cell phone technology have the potential to disrupt eating patterns. In this research, we focused on the camera function of a cell phone, characterizing: (i) the extent to which this function is used during meals; (ii) whether meal-time photographers show signs of pathological eating; and (iii) whether the act of taking food photographs alters the amount and enjoyment of food eaten. In the first study, we used the experience sampling method to track one week of meals from 137 young adults. Although we observed a low base rate of meal-time photography (5.44% of the 1140 meals captured), phone users who engaged in this practice had higher external eating scores than those who did not. That is, these meal-time photographers were more likely to eat in response to external cues (e.g. the sight of palatable food) than to internal cues of hunger. However, when participants were randomly assigned to take either food or non-food photographs within a lab setting (Study 2), we found no evidence that the type of photography influenced either the amount or enjoyment of food eaten. Taken together, our findings suggest a limited role for cell phone photography in an obesogenic environment.",2020,"Although we observed a low base rate of meal-time photography (5.44% of the 1140 meals captured), phone users who engaged in this practice had higher external eating scores than those who did not.",['137 young adults'],"['type of photography influenced either the amount or enjoyment of food eaten', 'food or non-food photographs']",['external eating scores'],"[{'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0031749', 'cui_str': 'Photography'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",137.0,0.0170038,"Although we observed a low base rate of meal-time photography (5.44% of the 1140 meals captured), phone users who engaged in this practice had higher external eating scores than those who did not.","[{'ForeName': 'Joceline Y Y', 'Initials': 'JYY', 'LastName': 'Yong', 'Affiliation': 'Division of Social Sciences, Yale-NUS College, 16 College Avenue West, Singapore, 138527, Singapore.'}, {'ForeName': 'Eddie M W', 'Initials': 'EMW', 'LastName': 'Tong', 'Affiliation': 'Department of Psychology, National University of Singapore, 9 Arts Link, Singapore, 117572, Singapore.'}, {'ForeName': 'Jean C J', 'Initials': 'JCJ', 'LastName': 'Liu', 'Affiliation': 'Division of Social Sciences, Yale-NUS College, 16 College Avenue West, Singapore, 138527, Singapore; Neuroscience and Behavioral Disorders Programme, Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore. Electronic address: jeanliu@yale-nus.edu.sg.'}]",Appetite,['10.1016/j.appet.2020.104787']
1328,32580032,Design of a cluster-randomized trial of the effectiveness and cost-effectiveness of metformin on prevention of type 2 diabetes among prediabetic Mexican adults (the PRuDENTE initiative of Mexico City).,"INTRODUCTION


Type 2 diabetes (T2D) is a global epidemic, and nations are struggling to implement effective healthcare strategies to reduce the burden. While efficacy studies demonstrate that metformin can reduce incident T2D by half among younger, obese adults with prediabetes, its real-world effectiveness are understudied, and its use for T2D prevention in primary care is low. We describe the design of a pragmatic trial to evaluate the incremental effectiveness of metformin, as an adjunct to a simple lifestyle counseling.
METHODS


The ""Prevención de la Diabetes con Ejercicio, Nutrición y Tratamiento"" [Diabetes Prevention with Exercise, Nutrition and Treatment; PRuDENTE, (Spanish acronym)] is a cluster-randomized trial in Mexico City's public primary healthcare system. The study randomly assigns 51 clinics to deliver one of two interventions for 36 months: 1) lifestyle only; 2) lifestyle plus metformin, to 3060 patients ages 30-65 with impaired fasting glucose and obesity. The primary endpoint is incident T2D (fasting glucose ≥126 mg/dL, or HbA1c ≥6.5%). We will also measure a range of implementation-related process outcomes at the clinic-, clinician- and patient-levels to inform interpretations of effectiveness and enable efforts to refine, adapt, adopt and disseminate the model. We will also estimate the cost-effectiveness of metformin as an adjunct to lifestyle counseling in Mexico.
DISCUSSION


Findings from this pragmatic trial will generate new translational knowledge in Mexico and beyond, both with respect to metformin's real-world effectiveness among an 'at-risk' population, and uncovering facilitators and barriers to the reach, adoption and implementation of metformin preventive therapy in public primary care settings.
TRIAL REGISTRATION


This trial is registered at Clinicaltrials.gov (NCT03194009).",2020,Nutrición y,"['prediabetic Mexican adults (the PRuDENTE initiative of Mexico City', '3060 patients ages 30-65 with impaired fasting glucose and obesity', 'Nutrición y']","['lifestyle only; 2) lifestyle plus metformin', 'metformin']","['incident T2D (fasting glucose ≥126\u202fmg/dL, or HbA1c ≥6.5']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",3060.0,0.0429361,Nutrición y,"[{'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Rodríguez', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA. Electronic address: Luis.Rodriguez@ucsf.edu.'}, {'ForeName': 'Simón', 'Initials': 'S', 'LastName': 'Barquera', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Aguilar-Salinas', 'Affiliation': 'Division of Nutrition, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Sepúlveda-Amor', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Luz María', 'Initials': 'LM', 'LastName': 'Sánchez-Romero', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Denova-Gutiérrez', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Nydia', 'Initials': 'N', 'LastName': 'Balderas', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Moreno-Loaeza', 'Affiliation': 'Research Unit on Metabolic Diseases, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico; Medical, Dental and Health Sciences, National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Handley', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Oliva', 'Initials': 'O', 'LastName': 'López-Arellano', 'Affiliation': 'Ministry of Health, Mexico City, Mexico.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Gallardo-Hernández', 'Affiliation': 'Ministry of Health, Mexico City, Mexico.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Schillinger', 'Affiliation': 'Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106067']
1329,32446880,Changes in parental feeding practices and preschoolers' food intake following a randomized controlled childhood obesity trial.,"Childhood obesity treatment involving parents is most effective during the preschool age. However, the mechanisms of change are not known. The present study reports on secondary outcomes (changes in parental feeding practices and child food intake) of early obesity treatment. The More and Less study is a randomized controlled trial conducted in Stockholm County, Sweden. Children with obesity (n = 174, mean BMI SDS 3.0, mean age 5 years, 56% girls) and their parents (60% with foreign background, 40% with a university degree) were randomized to: 1) standard treatment focusing on lifestyle recommendations (ST), 2) a parent support program with boosters (PGB), and 3) a parent support program without boosters (PGNB). The Child Feeding Questionnaire (CFQ) was used to measure parental feeding practices. Child food intake was assessed with a Food Frequency Questionnaire (FFQ). We calculated the monthly changes in CFQ practices and FFQ items based on four measurements. We did not find any significant between-group differences in parental feeding practices and child food intake over time. However, general linear models showed that changes in certain feeding practices predicted changes in child food intake. When ST was compared to the parent support groups, some associations moved in opposite directions. For example, increasing maternal restriction predicted increased consumption of cookies/buns in PGNB (b = 2.3, p < 0.05) and decreased consumption of cookies/buns in ST (b = -2.1, p < 0.05). This is among the few studies to examine the effect of parental feeding practices on child food intake and weight status after obesity treatment among preschoolers. We found no evidence that changes in feeding practices or changes in child food intake mediated child weight loss. Future studies should consider other intermediary processes related to general parenting practices and parent-child interactions.",2020,We did not find any significant between-group differences in parental feeding practices and child food habits over time.,"['Children with obesity (n\u202f=\u202f174, mean BMI SDS 3.0, mean age 5 years, 56% girls) and their parents (60% with foreign background, 40% with a university degree', 'child food habits and weight status after obesity treatment among preschoolers', 'Stockholm County, Sweden']","['standard treatment focusing on lifestyle recommendations (ST), 2) a parent support program with boosters (PGB), and 3) a parent support program without boosters (PGNB', 'parental feeding practices']","['Food Frequency Questionnaire (FFQ', 'parental feeding practices and child food habits) of early obesity treatment', 'consumption of cookies/buns in ST', 'Child Feeding Questionnaire (CFQ']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3853210', 'cui_str': 'Cookie'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}]",,0.0264302,We did not find any significant between-group differences in parental feeding practices and child food habits over time.,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Somaraki', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden. Electronic address: maria.somaraki@ikv.uu.se.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Eli', 'Affiliation': 'Unit for Biocultural Variation and Obesity, School of Anthropology and Museum Ethnography, University of Oxford, Oxford, UK; Social Science and Systems in Health, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK. Electronic address: karin.eli@anthro.ox.ac.uk.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Sorjonen', 'Affiliation': 'Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Solna, Sweden. Electronic address: kimmo.sorjonen@ki.se.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ek', 'Affiliation': 'Division of Pediatrics, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden. Electronic address: anna.ek@ki.se.'}, {'ForeName': 'Pernilla', 'Initials': 'P', 'LastName': 'Sandvik', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden. Electronic address: pernilla.sandvik@ikv.uu.se.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Nowicka', 'Affiliation': 'Department of Food Studies, Nutrition and Dietetics, Uppsala University, Uppsala, Sweden; Division of Pediatrics, Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institutet, Stockholm, Sweden. Electronic address: paulina.nowicka@ikv.uu.se.'}]",Appetite,['10.1016/j.appet.2020.104746']
1330,32448056,Mindfulness Meditation Improves Visual Short-Term Memory.,"Research into the effects of mindfulness meditation on behavioral outcomes has received much interest in recent years, with benefits for both short-term memory and working memory identified. However, little research has considered the potential effects of brief mindfulness meditation interventions or the nature of any benefits for visual short-term memory. Here, we investigate the effect of a single, 8-minute mindfulness meditation intervention, presented via audio recording, on a short-term memory task for faces. In comparison with two control groups (listening to an audiobook or simply passing the time however they wished), our mindfulness meditation participants showed greater increases in visual short-term memory capacity from pre- to post-intervention. In addition, only mindfulness meditation resulted in significant increases in performance. In conclusion, a single, brief mindfulness meditation intervention led to improvements in visual short-term memory capacity for faces, with important implications regarding the minimum intervention necessary to produce measurable changes in short-term memory tasks.",2020,"In conclusion, a single, brief mindfulness meditation intervention led to improvements in visual short-term memory capacity for faces, with important implications regarding the minimum intervention necessary to produce measurable changes in short-term memory tasks.",[],"['Mindfulness Meditation', '8-minute mindfulness meditation intervention, presented via audio recording, on a short-term memory task for faces', 'mindfulness meditation intervention', 'mindfulness meditation']","['performance', 'visual short-term memory capacity']",[],"[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.0183068,"In conclusion, a single, brief mindfulness meditation intervention led to improvements in visual short-term memory capacity for faces, with important implications regarding the minimum intervention necessary to produce measurable changes in short-term memory tasks.","[{'ForeName': 'Molly A', 'Initials': 'MA', 'LastName': 'Youngs', 'Affiliation': 'School of Psychology, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Samuel E', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': 'School of Psychology, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Michael O', 'Initials': 'MO', 'LastName': 'Mireku', 'Affiliation': 'School of Psychology, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Dinkar', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'School of Psychology, University of Kent, Canterbury, UK.'}, {'ForeName': 'Robin S S', 'Initials': 'RSS', 'LastName': 'Kramer', 'Affiliation': 'School of Psychology, University of Lincoln, Lincoln, UK.'}]",Psychological reports,['10.1177/0033294120926670']
1331,32460315,Defocus Incorporated Multiple Segments Spectacle Lenses Changed the Relative Peripheral Refraction: A 2-Year Randomized Clinical Trial.,"Purpose


To compare changes in relative peripheral refraction (RPR) associated with myopia progression in myopic children wearing Defocus Incorporated Multiple Segments (DIMS) lenses and single vision (SV) spectacle lenses over 2 years.
Methods


A 2-year double-blind, randomized controlled trial was conducted on 183 myopic children. Subjects were allocated to either wearing DIMS (n = 93) or SV spectacle lenses (n = 90). Peripheral refraction at 10°, 20°, and 30° of the nasal (10N, 20N, 30N) and temporal (10T, 20T, 30T) retinal eccentricities, central refraction, and axial length after cycloplegia were monitored every 6 months.
Results


DIMS group showed symmetrical peripheral myopic shifts between the nasal and temporal retina (comparing myopic shifts between the nasal and temporal retina, the difference between the corresponding eccentricities were nonclinically significance). SV group showed asymmetrical peripheral myopic shifts between the nasal and temporal retina, with more myopic shifts (all P ≤ 0.001) at 10T (-0.32 ± 0.62 diopters [D]), at 20T (-0.69 ± 0.95 D), and 30T (-0.85 ± 1.52 D). No significant changes in RPR spherical equivalent (M) were noted in the DIMS group, whereas significant increases (all P < 0.0001) in hyperopic RPR M were observed at 10N (0.27 ± 0.45 D), 20N (0.75 ± 0.72 D), and 30N (0.98 ± 0.76 D) in the SV group.
Conclusions


Wearing DIMS lenses resulted in a significantly different peripheral refraction profile and RPR changes, as well as significant myopia control effects when compared with SV lenses. Myopia control adopting myopic defocus in the midperiphery influenced peripheral refraction and slowed central myopia progression, most likely through alteration of overall retinal shape.",2020,"Myopia control adopting myopic defocus in the midperiphery influenced peripheral refraction and slowed central myopia progression, most likely through alteration of overall retinal shape.","['183 myopic children', 'myopic children wearing Defocus Incorporated']","['Multiple Segments (DIMS) lenses and single vision (SV) spectacle lenses', 'wearing DIMS', 'SV spectacle lenses']","['symmetrical peripheral myopic shifts', '30T) retinal eccentricities, central refraction, and axial length after cycloplegia', 'RPR spherical equivalent (M', 'peripheral refraction and slowed central myopia progression', 'hyperopic RPR M', 'relative peripheral refraction (RPR', 'Peripheral refraction', 'peripheral refraction profile and RPR changes', 'asymmetrical peripheral myopic shifts', 'Relative Peripheral Refraction', 'myopia control effects']","[{'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0181607', 'cui_str': 'Spectacle lens'}, {'cui': 'C1275648', 'cui_str': 'Single vision glasses'}]","[{'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0429585', 'cui_str': 'Refraction measurement - finding'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0235238', 'cui_str': 'Cycloplegia'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",183.0,0.154496,"Myopia control adopting myopic defocus in the midperiphery influenced peripheral refraction and slowed central myopia progression, most likely through alteration of overall retinal shape.","[{'ForeName': 'Han Yu', 'Initials': 'HY', 'LastName': 'Zhang', 'Affiliation': ',.'}, {'ForeName': 'Carly Siu Yin', 'Initials': 'CSY', 'LastName': 'Lam', 'Affiliation': ',.'}, {'ForeName': 'Wing Chun', 'Initials': 'WC', 'LastName': 'Tang', 'Affiliation': ',.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'Leung', 'Affiliation': ',.'}, {'ForeName': 'Chi Ho', 'Initials': 'CH', 'LastName': 'To', 'Affiliation': ',.'}]",Investigative ophthalmology & visual science,['10.1167/iovs.61.5.53']
1332,32461554,Colchicine's effects on metabolic and inflammatory molecules in adults with obesity and metabolic syndrome: results from a pilot randomized controlled trial.,"OBJECTIVE


Recent clinical trials have demonstrated that colchicine may have metabolic and cardiovascular and benefits in at-risk patients; however, the mechanisms through which colchicine may improve outcomes are still unclear. We sought to examine colchicine's effects on circulating inflammatory and metabolic molecules in adults with obesity and metabolic syndrome (MetS).
METHODS


Blood samples were collected pre- and post-intervention during a double-blind randomized controlled trial in which 40 adults with obesity and MetS were randomized to colchicine 0.6 mg or placebo twice-daily for 3 months. Serum samples were analyzed for 1305 circulating factors using the SomaScan Platform. The Benjamini-Hochberg procedure was used to adjust the false discovery rate (FDR) for multiple testing.
RESULTS


At baseline, age (48.0 ± 13.8 vs. 44.7 ± 10.3 years) and BMI (39.8 ± 6.4 vs. 41.8 ± 8.2 kg/m 2 ) were not different between groups. After controlling for the FDR, 34 molecules were significantly changed by colchicine. Colchicine decreased concentrations of multiple inflammatory molecules, including C-reactive protein, interleukin 6, and resistin, in addition to vascular-related proteins (e.g., oxidized low-density lipoprotein receptor, phosphodiesterase 5A). Conversely, relative to placebo, colchicine significantly increased concentrations of eight molecules including secreted factors associated with metabolism and anti-thrombosis.
CONCLUSIONS


In adults with obesity, colchicine significantly affected concentrations of proteins involved in the innate immune system, endothelial function and atherosclerosis, uncovering new mechanisms behind its cardiometabolic effects. Further research is warranted to investigate whether colchicine's IL-6 suppressive effects may be beneficial in COVID-19.",2020,"Colchicine decreased concentrations of multiple inflammatory molecules, including C-reactive protein, interleukin 6, and resistin, in addition to vascular-related proteins (e.g., oxidized low-density lipoprotein receptor, phosphodiesterase 5A).","['adults with obesity and metabolic syndrome', '40 adults with obesity and MetS', 'adults with obesity and metabolic syndrome (MetS', 'At baseline, age (48.0\u2009±\u200913.8 vs. 44.7\u2009±\u200910.3 years) and BMI (39.8\u2009±\u20096.4 vs. 41.8\u2009±\u20098.2\u2009kg/m 2 ']","['placebo, colchicine', 'Colchicine', 'colchicine', ""Colchicine's"", 'colchicine 0.6\u2009mg or placebo']","['concentrations of multiple inflammatory molecules, including C-reactive protein, interleukin 6, and resistin', 'metabolic and inflammatory molecules', 'circulating inflammatory and metabolic molecules', 'false discovery rate (FDR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517822', 'cui_str': '6.4'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0985108', 'cui_str': 'Colchicine 0.6 MG'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0205557', 'cui_str': 'False positive'}]",40.0,0.602228,"Colchicine decreased concentrations of multiple inflammatory molecules, including C-reactive protein, interleukin 6, and resistin, in addition to vascular-related proteins (e.g., oxidized low-density lipoprotein receptor, phosphodiesterase 5A).","[{'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Demidowich', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, 20892-1103, USA. ademido1@jh.edu.'}, {'ForeName': 'Jordan A', 'Initials': 'JA', 'LastName': 'Levine', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, 20892-1103, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Apps', 'Affiliation': 'Center for Human Immunology (CHI), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Foo K', 'Initials': 'FK', 'LastName': 'Cheung', 'Affiliation': 'Center for Human Immunology (CHI), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Jinguo', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Center for Human Immunology (CHI), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, 20892, USA.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Fantoni', 'Affiliation': 'Center for Human Immunology (CHI), National Institute of Allergy and Infectious Diseases, NIH, Bethesda, MD, 20892, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Tushar P', 'Initials': 'TP', 'LastName': 'Patel', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, 20892-1103, USA.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Yanovski', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, MD, 20892-1103, USA.'}]",International journal of obesity (2005),['10.1038/s41366-020-0598-3']
1333,32464280,"Regorafenib after failure of gemcitabine and platinum-based chemotherapy for locally advanced/metastatic biliary tumors: REACHIN, a randomized, double-blind, phase II trial.","BACKGROUND


There is a high unmet clinical need for treatments of advanced/metastatic biliary tract cancers after progression on first-line chemotherapy. Regorafenib has demonstrated efficacy in some gastrointestinal tumors that progress on standard therapies.
PATIENTS AND METHODS


REACHIN was a multicenter, double-blind, placebo-controlled, randomized phase II study designed to evaluate the safety and efficacy of regorafenib in patients with nonresectable/metastatic biliary tract cancer that progressed after gemcitabine/platinum chemotherapy. Patients were randomly assigned 1 : 1 to best supportive care plus either regorafenib 160 mg once daily 3 weeks on/1 week off or placebo until progression or unacceptable toxicity. No crossover was allowed. The primary objective was progression-free survival (PFS). Secondary objectives were response rate, overall survival, and translational analysis.
RESULTS


Sixty-six patients with intrahepatic (n = 42), perihilar (n = 6), or extrahepatic (n = 9) cholangiocarcinoma, or gallbladder carcinoma (n = 9) were randomized, 33 to each treatment group (33 per group). At a median follow-up of 24 months, all patients had progressed and six patients were alive. Median treatment duration was 11.0 weeks [95% confidence interval (CI): 6.0-15.9] in the regorafenib group and 6.3 weeks (95% CI: 3.9-7.0) in the placebo group (P = 0.002). Fourteen of 33 patients (42%) in the regorafenib group had a dose reduction. Stable disease rates were 74% (95% CI: 59-90) in the regorafenib group and 34% with placebo (95% CI: 18-51; P = 0.002). Median PFS in the regorafenib group was 3.0 months (95% CI: 2.3-4.9) and 1.5 months (95% CI: 1.2-2.0) in the placebo group (hazard ratio 0.49; 95% CI: 0.29-0.81; P = 0.004) and median overall survival was 5.3 months (95% CI: 2.7-10.5) and 5.1 months (95% CI: 3.0-6.4), respectively (P = 0.28). There were no unexpected/new safety signals.
CONCLUSION


Regorafenib significantly improved PFS and tumor control in patients with previously treated metastatic/unresectable biliary tract cancer in the second- or third-line setting.
CLINICAL TRIAL REGISTRATION


The trial is registered in the European Clinical Trials Register database (EudraCT 2012-005626-30) and at ClinicalTrials.gov (NCT02162914).",2020,Stable disease rates were 74% (95%CI: 59-90) in the regorafenib group and 34% with placebo (95%CI: 18-51; p=0.002).,"['advanced/metastatic biliary tract cancers (BTC) after progression on first-line chemotherapy', 'patients with previously treated metastatic/unresectable BTC in the second- or third-line setting', 'locally advanced/metastatic biliary tumors', 'patients with nonresectable/metastatic BTC that progressed after', 'Sixty-six patients with intra-hepatic (n=42), peri-hilar (n=6), or extra-hepatic (n=9) cholangiocarcinoma, or gallbladder carcinoma (n=9']","['regorafenib', 'supportive care plus either regorafenib', 'Regorafenib', 'gemcitabine/platinum chemotherapy', 'gemcitabine and platinum-based chemotherapy', 'placebo']","['PFS and tumor control', 'Median PFS', 'median OS', 'Stable disease rates', 'Median treatment duration', 'safety and efficacy', 'progression-free survival (PFS', 'response rate, overall survival (OS), and translational analysis']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0750952', 'cui_str': 'Malignant tumor of biliary tract'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0005426', 'cui_str': 'Neoplasm of biliary tract'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0205150', 'cui_str': 'Hilar'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocarcinoma'}, {'cui': 'C0235782', 'cui_str': 'Carcinoma of gallbladder'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",66.0,0.690482,Stable disease rates were 74% (95%CI: 59-90) in the regorafenib group and 34% with placebo (95%CI: 18-51; p=0.002).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Demols', 'Affiliation': 'GE and Digestive Oncology Department, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium. Electronic address: anne.demols@erasme.ulb.ac.be.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Borbath', 'Affiliation': 'GE Department, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van den Eynde', 'Affiliation': 'GE Department, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Houbiers', 'Affiliation': 'Oncology Department, Saint-Joseph Community Health Center, Liège, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Oncology Department - University Hospital Antwerp, Edegem, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marechal', 'Affiliation': 'GE and Digestive Oncology Department, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Delaunoit', 'Affiliation': 'GE Department, INDC Entité Jolimontoise, Haine-St-Paul, Belgium.'}, {'ForeName': 'J-C', 'Initials': 'JC', 'LastName': 'Goemine', 'Affiliation': 'Oncology Department, Cliniques et Maternité Ste Elisabeth, Namur, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Laurent', 'Affiliation': 'GE Department - Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Holbrechts', 'Affiliation': 'Oncology Department, Centre Hospitalier Universitaire A. Paré, Mons, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Paesmans', 'Affiliation': 'Data Center, Institut J. Bordet, Brussels, Belgium.'}, {'ForeName': 'J-L', 'Initials': 'JL', 'LastName': 'Van Laethem', 'Affiliation': 'GE and Digestive Oncology Department, CUB Hôpital Erasme, Université Libre de Bruxelles, Brussels, Belgium.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.018']
1334,32580978,Hepatic venous pressure gradient-guided laparoscopic splenectomy and pericardial devascularisation versus endoscopic therapy for secondary prophylaxis for variceal rebleeding in portal hypertension (CHESS1803): study protocol of a multicenter randomised controlled trial in China.,"INTRODUCTION


Gastro-oesophageal variceal bleeding is one of the most common and severe complications with high mortality in cirrhotic patients who developed portal hypertension. Hepatic venous pressure gradient (HVPG) is a globally recommended golden standard for the portal pressure assessment and an HVPG ≥16 mm Hg indicates a higher risk of death and rebleeding. This study aims to compare the effectiveness and safety of splenectomy and pericardial devascularisation (laparoscopic therapy) plus propranolol and endoscopic therapy plus propranolol for variceal rebleeding in cirrhotic patients with HVPG between 16 and 20 mm Hg.
METHODS AND ANALYSIS


This is a multicenter, randomised, controlled clinical trial. Participants will be 1:1 assigned randomly into either laparoscopic or endoscopic groups. Forty participants whose transjugular HVPG lies between 16 and 20 mm Hg with a history of gastro-oesophageal variceal bleeding will be recruited from three sites in China. Participants will receive either endoscopic therapy plus propranolol or laparoscopic therapy plus propranolol. The primary outcome measure will be the occurrence of gastro-oesophageal variceal rebleeding. Secondary outcome measures will include overall survival, occurrence of hepatocellular carcinoma, the occurrence of venous thrombosis, the occurrence of adverse events, quality of life and tolerability of treatment. Outcome measures will be evaluated at baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks and 60 weeks. Multivariate COX regression model will be introduced for analyses of occurrence data and Kaplan-Meier analysis with the log-rank test for intergroup comparison.
ETHICS AND DISSEMINATION


Ethical approval was obtained from all three participating sites. Primary and secondary outcome data will be submitted for publication in peer-reviewed journals and widely disseminated.
TRIAL REGISTRATION NUMBER


NCT03783065; Pre-results.
TRIAL STATUS


Recruitment for this study started in December 2018 while the first participant was randomised in January 2019. Recruitment is estimated to stop in October 2019.",2020,Hepatic venous pressure gradient (HVPG) is a globally recommended golden standard for the portal pressure assessment and an HVPG ≥16 mm Hg indicates a higher risk of death and rebleeding.,"['Recruitment for this study started in December 2018 while the first participant was randomised in January 2019', 'Forty participants whose transjugular HVPG lies between 16 and 20\u2009mm Hg with a history of gastro-oesophageal variceal bleeding will be recruited from three sites in China', 'cirrhotic patients who developed portal hypertension', 'cirrhotic patients with HVPG between 16 and 20\u2009mm Hg']","['Hepatic venous pressure gradient-guided laparoscopic splenectomy and pericardial devascularisation versus endoscopic therapy', 'laparoscopic or endoscopic groups', 'Hepatic venous pressure gradient (HVPG', 'endoscopic therapy plus propranolol or laparoscopic therapy plus propranolol', 'splenectomy and pericardial devascularisation (laparoscopic therapy) plus propranolol and endoscopic therapy plus propranolol']","['occurrence of gastro-oesophageal variceal rebleeding', 'variceal rebleeding', 'overall survival, occurrence of hepatocellular carcinoma, the occurrence of venous thrombosis, the occurrence of adverse events, quality of life and tolerability of treatment', 'submitted for publication in peer-reviewed journals and widely disseminated']","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C4049263', 'cui_str': 'Hepatic venous pressure gradient'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020541', 'cui_str': 'Portal hypertension'}]","[{'cui': 'C4049263', 'cui_str': 'Hepatic venous pressure gradient'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0442031', 'cui_str': 'Pericardial'}, {'cui': 'C0581712', 'cui_str': 'Devascularization - action'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C0030768', 'cui_str': 'Peer review'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}]",,0.224228,Hepatic venous pressure gradient (HVPG) is a globally recommended golden standard for the portal pressure assessment and an HVPG ≥16 mm Hg indicates a higher risk of death and rebleeding.,"[{'ForeName': 'Ruoyang', 'Initials': 'R', 'LastName': 'Shao', 'Affiliation': 'CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Zhiwei', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Hepatobiliary Surgery, The Third People's Hospital of Shenzhen, Shenzhen, China.""}, {'ForeName': 'Jitao', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatobiliary Surgery, Xingtai Institute of Cancer Control, Xingtai, China.'}, {'ForeName': 'Ruizhao', 'Initials': 'R', 'LastName': 'Qi', 'Affiliation': 'Department of General Surgery, The Fifth Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Qingbo', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Hepatobiliary Surgery, Shunde Hospital, Southern Medical University, Foshan, China.'}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary Surgery, Shunde Hospital, Southern Medical University, Foshan, China.'}, {'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Mao', 'Affiliation': 'CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Yanna', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': ""Department of Hepatobiliary Surgery, The Third People's Hospital of Shenzhen, Shenzhen, China.""}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China.'}, {'ForeName': 'Changzeng', 'Initials': 'C', 'LastName': 'Zuo', 'Affiliation': 'Department of Hepatobiliary Surgery, Xingtai Institute of Cancer Control, Xingtai, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatobiliary Surgery, Shunde Hospital, Southern Medical University, Foshan, China qixiaolong@vip.163.com weiweih@126.com.'}, {'ForeName': 'Xiaolong', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'CHESS Center, Institute of Portal Hypertension, The First Hospital of Lanzhou University, Lanzhou, China qixiaolong@vip.163.com weiweih@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-030960']
1335,32580980,Effectiveness of a comprehensive care protocol in patients with new diagnoses of type 2 diabetes mellitus and associated comorbidities in primary care: study protocol of a quasi-experimental trial.,"INTRODUCTION


Type 2 diabetes mellitus (T2DM) is a highly prevalent chronic disease in the Spanish population. Typically, T2DM is associated with other chronic conditions. Intensive medication at the time of diagnosis has proven effective in reducing cardiovascular risk, improving glycaemic control and preventing T2DM complications. However, it has not yet been demonstrated that a comprehensive and intensive health education protocol at the time of diagnosis has the benefits described previously. Currently, there is great variability in the practices of primary care nurses regarding health education at the time of disease diagnosis.We aimed to evaluate the effectiveness of a systematic protocol with a comprehensive care programme in people with newly diagnosed T2DM with associated comorbidities.
METHODS AND ANALYSIS


A multicentre quasi-experimental design comparing a group of individuals taking part in the intervention (intervention group (IG)) with a similar group receiving standard diabetes care (comparison group (CG)) is planned. The intervention will take place during the 3 months after study enrolment. Data will be collected at baseline and at 3, 6 and 12 months. Ten primary care centres in Barcelona city will be selected for participation: 5 for the IG and 5 for the CG. The IG will include five structured individual visits postdiagnosis with the primary care nurse, during which aspects of diabetes education will be discussed with the patient and his/her family. The results will be measured in terms of health-related quality of life and the change in main outcomes (glycated haemoglobin and weight).
ETHICS AND DISSEMINATION


The study fully met the requirements of the Ethical Committee of Clinical Investigation of the IDIAP Jordi Gol (approval code: P13/118). Patients will be informed that their data are confidential, and they have the right to withdraw at any time without penalty. Dissemination will include publishing the findings in peer-reviewed journals and sharing our findings at scientific conferences.
TRIAL REGISTRATION NUMBER


NCT03990857; Pre-results.",2020,"Intensive medication at the time of diagnosis has proven effective in reducing cardiovascular risk, improving glycaemic control and preventing T2DM complications.","['people with newly diagnosed T2DM with associated comorbidities', 'patients with new diagnoses of type 2 diabetes mellitus and associated comorbidities in primary care', 'Ten primary care centres in Barcelona city will be selected for participation: 5 for the IG and 5 for the CG']","['comprehensive care protocol', 'systematic protocol with a comprehensive care programme', 'intervention (intervention group (IG)) with a similar group receiving standard diabetes care (comparison group (CG']","['cardiovascular risk, improving glycaemic control and preventing T2DM complications']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0009586', 'cui_str': 'Comprehensive Healthcare'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0609571,"Intensive medication at the time of diagnosis has proven effective in reducing cardiovascular risk, improving glycaemic control and preventing T2DM complications.","[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Lapena', 'Affiliation': ""Centre d'Atenció Primària Sanllehy, Gerència d'Àmbit d'Atenció Primària Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain clapena@gencat.cat.""}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Borràs', 'Affiliation': 'Gerència Territorial de Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain.'}, {'ForeName': 'Clarisa', 'Initials': 'C', 'LastName': 'Digon', 'Affiliation': ""Centre d'Atenció Primària Sagrera, Gerència d'Àmbit d'Atenció Primària Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Aznar', 'Affiliation': ""Centre d'Atenció Primària Sanllehy, Gerència d'Àmbit d'Atenció Primària Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain.""}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Del Val Garcia', 'Affiliation': 'Unitat de Suport a la Recerca Barcelona Ciutat, Fundació Institut Universitari per a la recerca en Atenció Primària de Salut Jordi Gol i Gurina (IDIAP Jordi Gol), Barcelona, Spain.'}, {'ForeName': 'Esmeralda', 'Initials': 'E', 'LastName': 'Castelblanco', 'Affiliation': ""DAP-Cat Group, Unitat de Suport a la Recerca Barcelona, Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Spain.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Garaikoetxea', 'Affiliation': ""Centre d'Atenció Primària Sanllehy, Gerència d'Àmbit d'Atenció Primària Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain.""}, {'ForeName': 'Vicencia', 'Initials': 'V', 'LastName': 'Laguna', 'Affiliation': ""Centre d'Atenció Primària Sanllehy, Gerència d'Àmbit d'Atenció Primària Barcelona Ciutat, Institut Català de la Salut, Barcelona, Spain.""}]",BMJ open,['10.1136/bmjopen-2019-033725']
1336,32580979,Validation of the Transition Readiness and Appropriateness Measure (TRAM) for the Managing the Link and Strengthening Transition from Child to Adult Mental Healthcare in Europe (MILESTONE) study.,"OBJECTIVE


Young people moving from child and adolescent mental health services (CAMHS) to adult mental health services (AMHS) are faced with significant challenges. To improve this state of affairs, there needs to be a recognition of the problem and initiatives and an urgent requirement for appropriate tools for measuring readiness and outcomes at the transfer boundary (16-18 years of age in Europe). The objective of this study was to develop and validate the Transition Readiness and Appropriateness Measure (TRAM) for assessing a young person's readiness for transition, and their outcomes at the transfer boundary.
DESIGN


MILESTONE prospective study.
SETTING


Eight European Union (EU) countries participating in the EU-funded MILESTONE study.
PARTICIPANTS


The first phase (MILESTONE validation study) involved 100 adolescents (pre-transition), young adults (post-transition), parents/carers and both CAMHS and AMHS clinicians. The second phase (MILESTONE cohort study and nested cluster randomised trial) involved over 1000 young people.
RESULTS


The development of the TRAM began with a literature review on transitioning and a review of important items regarding transition by a panel of 34 mental health experts. A list of 64 items of potential importance were identified, which together comprised the TRAM. The psychometric properties of the different versions of the TRAM were evaluated and showed that the TRAM had good reliability for all versions and low-to-moderate correlations when compared with other established instruments and a well-defined factor structure. The main results of the cohort study with the nested cluster randomised trial are not reported.
CONCLUSION


The TRAM is a reliable instrument for assessing transition readiness and appropriateness. It highlighted the barriers to a successful transition and informed clinicians, identifying areas which clinicians on both sides of the transfer boundary can work on to ease the transition for the young person.
TRIAL REGISTRATION NUMBER


ISRCTN83240263 (Registered 23 July 2015), NCT03013595 (Registered 6 January 2017); Pre-results.",2020,The psychometric properties of the different versions of the TRAM were evaluated and showed that the TRAM had good reliability for all versions and low-to-moderate correlations when compared with other established instruments and a well-defined factor structure.,"['100 adolescents (pre-transition), young adults (post-transition), parents/carers and both CAMHS and AMHS clinicians', '1000 young people', 'Eight European Union (EU) countries participating in the EU-funded MILESTONE study', 'Young people moving from child and adolescent mental health services (CAMHS) to adult mental health services (AMHS']",['Transition Readiness and Appropriateness Measure (TRAM'],['Transition Readiness and Appropriateness Measure (TRAM'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1269909', 'cui_str': 'MOVED FROM'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0486327,The psychometric properties of the different versions of the TRAM were evaluated and showed that the TRAM had good reliability for all versions and low-to-moderate correlations when compared with other established instruments and a well-defined factor structure.,"[{'ForeName': 'Paramala', 'Initials': 'P', 'LastName': 'Santosh', 'Affiliation': ""Child and Adolescent Psychiatry, King's College London, London, UK paramala.1.santosh@kcl.ac.uk.""}, {'ForeName': 'Jatinder', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': ""Child and Adolescent Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Adams', 'Affiliation': 'School of Psychology, University of Plymouth, Plymouth, Devon, UK.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Mastroianni', 'Affiliation': ""Child and Adolescent Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Heaney', 'Affiliation': ""Child and Adolescent Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Lievesley', 'Affiliation': 'HealthTracker, Gillingham, UK.'}, {'ForeName': 'Ilyas', 'Initials': 'I', 'LastName': 'Sagar-Ouriaghli', 'Affiliation': ""Child and Adolescent Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Allibrio', 'Affiliation': 'Unit of Neuropsychiatry, ASST Spedali Civili di Brescia Dipartimento di Salute Mentale, Brescia, Lombardia, Italy.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Appleton', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Nikolina', 'Initials': 'N', 'LastName': 'Davidović', 'Affiliation': 'Department of Psychiatry, Clinical Hospital Center Split, Split, Croatia.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'de Girolamo', 'Affiliation': 'Psychiatric Epidemiology and Evaluation Unit, Saint John of God Clinical Research Center, Brescia, Italy.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Dieleman', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Dodig-Ćurković', 'Affiliation': 'Department of Pediatric and Adolescent Psychiatry, KBC Osijek, Osijek, Croatia.'}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Franić', 'Affiliation': 'Department of Psychiatry, Clinical Hospital Center Split, Split, Croatia.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Gatherer', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Gheza', 'Affiliation': 'Neuropsychiatry Service of Childhood and Adolescence, Mental Health Department, ASST della Valcamonica, Breno, Lombardia, Italy.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Madan', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, Coventry, UK.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Manenti', 'Affiliation': 'Unit of Neuropsychiatry, ASST Spedali Civili di Brescia Dipartimento di Salute Mentale, Brescia, Lombardia, Italy.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Maras', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Margari', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari, Bari, Puglia, Italy.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'McNicholas', 'Affiliation': 'School of Medicine and Medical Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Pastore', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari, Bari, Puglia, Italy.'}, {'ForeName': 'Moli', 'Initials': 'M', 'LastName': 'Paul', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Purper-Ouakil', 'Affiliation': 'Psychological Medicine for Children and Adolescents, Centre Hospitalier Regional Universitaire de Montpellier, Montpellier, Languedoc-Roussillon, France.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Rinaldi', 'Affiliation': 'Neuropsychiatry Service of Childhood and Adolescence, Mental Health Department, ASST della Valcamonica, Breno, Lombardia, Italy.'}, {'ForeName': 'Vehbi', 'Initials': 'V', 'LastName': 'Sakar', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychotherapy, Universitatsklinikum Ulm, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Schulze', 'Affiliation': 'Department of Child and Adolescent Psychiatry/Psychotherapy, Universitatsklinikum Ulm, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Signorini', 'Affiliation': 'Psychiatric Epidemiology and Evaluation Unit, Saint John of God Clinical Research Center, Brescia, Italy.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Street', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Tah', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Tremmery', 'Affiliation': 'Department of Neurosciences, Child & Adolescent Psychiatry, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Tuffrey', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Tuomainen', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Verhulst', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Warwick', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, Coventry, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Wolke', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Fiori', 'Affiliation': ""Child and Adolescent Psychiatry, King's College London, London, UK.""}, {'ForeName': 'Swaran', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033324']
1337,32580984,Occupational therapist-led mindfulness-based stress reduction for older adults living with subjective cognitive decline or mild cognitive impairment in primary care: a feasibility randomised control trial protocol.,"INTRODUCTION


Community-dwelling older adults living with subjective cognitive decline or mild cognitive impairment may experience decreased efficiency in their overall functional performance. This decreased cognitive efficiency may result in anxiety, low mood, perceived stress and decreased emotional well-being and quality-of-life. These psychological symptoms may further exacerbate cognitive decline.Exploring non-pharmacological interventions such as mindfulness within primary care is vital in enabling individuals to develop strategies to manage cognitive impairment or psychological symptoms. Mindfulness-based stress reduction (MBSR) is an 8-week programme that is beneficial in alleviating psychological symptoms; however, its impact on perceived satisfaction on overall functional performance with this population has not been evaluated. The primary objective of this study is to explore the feasibility of conducting a randomised controlled trial of an occupational therapist-led MBSR programme within primary care.
METHODS


Convergent mixed-methods, randomised control feasibility trial with 40 participants from an interprofessional primary care team in Toronto, Ontario. Participants are randomised into the 8-week MBSR group or wait-list control will be compared at baseline, postintervention and 4weeks follow-up. The primary aim is to determine the feasibility of the intervention with this population and setting. The secondary aim is to examine perceived satisfaction with functional performance as measured by the Canadian Occupational Performance Measure. Secondary clinical outcomes include psychological symptoms.
ANALYSIS


Investigators will analyse the quantitative and qualitative data strands separately. Descriptive statistics, focus group and interviews will then be merged and further analysed to best understand the feasibility and preliminary clinical outcomes from the study.
ETHICS AND DISSEMINATION


The study is approved by Women's College Hospital (2017-0056-E), and Queen's University, Kingston, Ontario (6026418). The study will follow Standard Protocol Items: Recommendations for Interventional Trials. The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media. Trial registration number NCT03867474; Pre-results.",2020,"Mindfulness-based stress reduction (MBSR) is an 8-week programme that is beneficial in alleviating psychological symptoms; however, its impact on perceived satisfaction on overall functional performance with this population has not been evaluated.","['Community-dwelling older adults living with subjective cognitive decline or mild cognitive impairment', ""Women's College Hospital (2017-0056-E), and Queen's University, Kingston, Ontario (6026418"", 'older adults living with subjective cognitive decline or mild cognitive impairment in primary care', '40 participants from an interprofessional primary care team in Toronto, Ontario']","['Mindfulness-based stress reduction (MBSR', 'MBSR group or wait-list control', 'occupational therapist-led MBSR programme', 'Occupational therapist-led mindfulness-based stress reduction']","['cognitive efficiency', 'psychological symptoms']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}]",40.0,0.109064,"Mindfulness-based stress reduction (MBSR) is an 8-week programme that is beneficial in alleviating psychological symptoms; however, its impact on perceived satisfaction on overall functional performance with this population has not been evaluated.","[{'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Tran', 'Affiliation': ""Family Practice, Women's College Hospital, Toronto, Ontario, Canada Todd.tran@wchospital.ca.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Donnelly', 'Affiliation': ""Rehabilitation Therapy, Queen's University Faculty of Health Sciences, Kingston, Ontario, Canada.""}, {'ForeName': 'Emily Joan', 'Initials': 'EJ', 'LastName': 'Nalder', 'Affiliation': 'Occupational Science and Occupational Therapy, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Trothen', 'Affiliation': ""Rehabilitation Therapy, Queen's University Faculty of Health Sciences, Kingston, Ontario, Canada.""}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Finlayson', 'Affiliation': ""Rehabilitation Therapy, Queen's University Faculty of Health Sciences, Kingston, Ontario, Canada.""}]",BMJ open,['10.1136/bmjopen-2019-035299']
1338,32484818,The impact of a high-quality basic life support police-based first responder system on outcome after out-of-hospital cardiac arrest.,"BACKGROUND


Laypersons' efforts to initiate basic life support (BLS) in witnessed Out-of-Hospital Cardiac Arrest (OHCA) remain comparably low within western society. Therefore, in order to shorten no-flow times in cardiac arrest, several police-based first responder systems equipped with automated external defibrillators (Pol-AED) were established in urban areas, which subsequently allow early BLS and AED administration by police officers. However, data on the quality of BLS and AED use in such a system and its impact on patient outcome remain scarce and inconclusive.
METHODS


A total of 85 Pol-AED cases were randomly assigned to a gender, age and first rhythm matched non-Pol-AED control group (n = 170) in a 1:2 ratio. Data on quality of BLS were extracted via trans-thoracic impedance tracings of used AED devices.
RESULTS


Comparing Pol-AED cases and the control group, we observed a similar compression rate per minute (p = 0.677) and compression ratio (p = 0.651), mirroring an overall high quality of BLS administered by police officers. Time to the first shock was significantly shorter in Pol-AED cases (6 minutes [IQR: 2-10] vs. 12 minutes [IQR: 8-17]; p<0.001). While Pol-AED was not associated with increased sustained return of spontaneous circulation (p = 0.564), a strong and independent impact on survival until hospital discharge (adj. OR: 1.85 [95%CI: 1.06-3.23; p = 0.030]) and a borderline significance for the association with favorable neurological outcome (adj. OR: 1.58 [95%CI: 0.96-2.89; p = 0.052) were observed.
CONCLUSION


We were able to demonstrate an early start and a high quality of BLS and AED use in Pol-AED assessed OHCA cases. Moreover, the presence of Pol-AED care was associated with better patient survival and borderline significance for favorable neurological outcome.",2020,"While Pol-AED was not associated with increased sustained return of spontaneous circulation (p = 0.564), a strong and independent impact on survival until hospital discharge (adj.",['A total of 85 Pol-AED cases'],['high-quality basic life support police-based first responder system'],"['compression rate per minute', 'quality of BLS', 'survival until hospital discharge', 'compression ratio', 'sustained return of spontaneous circulation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085098', 'cui_str': 'Police'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0180309', 'cui_str': 'Automated External Defibrillators'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0085098', 'cui_str': 'Police'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178988', 'cui_str': 'Emergency First Responders'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}]",170.0,0.0618399,"While Pol-AED was not associated with increased sustained return of spontaneous circulation (p = 0.564), a strong and independent impact on survival until hospital discharge (adj.","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Krammel', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Lobmeyr', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sulzgruber', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Winnisch', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Weidenauer', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Poppe', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Datler', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Zeiner', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Keferboeck', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Eichelter', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hamp', 'Affiliation': 'Department of Anesthesiology, Intensive Care and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Uray', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schnaubelt', 'Affiliation': 'PULS-Austrian Cardiac Arrest Awareness Association, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Nuernberger', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}]",PloS one,['10.1371/journal.pone.0233966']
1339,32581088,Rituximab as therapy to induce remission after relapse in ANCA-associated vasculitis.,"OBJECTIVES


Evaluation of rituximab and glucocorticoids as therapy to induce remission after relapse in ANCA-associated vasculitis (AAV) in a prospective observational cohort of patients enrolled into the induction phase of the RITAZAREM trial.
METHODS


Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis were prospectively enrolled and received remission-induction therapy with rituximab (4×375 mg/m 2 ) and a higher or lower dose glucocorticoid regimen, depending on physician choice: reducing from either 1 mg/kg/day or 0.5 mg/kg/day to 10 mg/day by 4 months. Patients in this cohort achieving remission were subsequently randomised to receive one of two regimens to prevent relapse.
RESULTS


188 patients were studied: 95/188 (51%) men, median age 59 years (range 19-89), prior disease duration 5.0 years (range 0.4-34.5). 149/188 (79%) had previously received cyclophosphamide and 67/188 (36%) rituximab. 119/188 (63%) of relapses had at least one major disease activity item, and 54/188 (29%) received the higher dose glucocorticoid regimen. 171/188 (90%) patients achieved remission by 4 months. Only six patients (3.2% of the study population) did not achieve disease control at month 4. Four patients died in the induction phase due to pneumonia (2), cerebrovascular accident (1), and active vasculitis (1). 41 severe adverse events occurred in 27 patients, including 13 severe infections.
CONCLUSIONS


This large prospective cohort of patients with relapsing AAV treated with rituximab in conjunction with glucocorticoids demonstrated a high level of efficacy for the reinduction of remission in patients with AAV who have relapsed, with a similar safety profile to previous studies.",2020,"41 severe adverse events occurred in 27 patients, including 13 severe infections.
","['Patients relapsing with granulomatosis with polyangiitis or microscopic polyangiitis', 'patients with relapsing AAV treated with', 'patients enrolled into the induction phase of the RITAZAREM trial', '188 patients were studied: 95/188 (51%) men, median age 59 years (range 19-89), prior disease duration 5.0 years', 'patients with AAV who have relapsed, with a similar safety profile to previous studies']","['cyclophosphamide', 'rituximab and glucocorticoids', 'Rituximab', 'remission-induction therapy with rituximab (4×375\u2009mg/m 2 ) and a higher or lower dose glucocorticoid regimen', 'rituximab in conjunction with glucocorticoids', 'rituximab']",['41 severe adverse events'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C3495801', 'cui_str': 'Granulomatosis with polyangiitis'}, {'cui': 'C2347126', 'cui_str': 'Microscopic polyarteritis nodosa'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205156', 'cui_str': 'Previous'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0035052', 'cui_str': 'Induction of Remission'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",188.0,0.0880274,"41 severe adverse events occurred in 27 patients, including 13 severe infections.
","[{'ForeName': 'Rona M', 'Initials': 'RM', 'LastName': 'Smith', 'Affiliation': 'University of Cambridge, Cambridge, UK ronasmith@doctors.net.uk.'}, {'ForeName': 'Rachel Bronwen', 'Initials': 'RB', 'LastName': 'Jones', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Nodale', 'Affiliation': 'Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Aljayyousi', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, Leicester, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Andrews', 'Affiliation': 'NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds Teaching Hospitals Trust, Leeds, UK.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bruchfeld', 'Affiliation': 'Department of Renal Medicine, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Camilleri', 'Affiliation': 'Ipswich Hospital NHS Trust, Ipswich, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Carette', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Chee Kay', 'Initials': 'CK', 'LastName': 'Cheung', 'Affiliation': 'University of Leicester, Leicester, UK.'}, {'ForeName': 'Vimal', 'Initials': 'V', 'LastName': 'Derebail', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Doulton', 'Affiliation': 'East Kent Hospitals University NHS Foundation Trust, Canterbury, Kent, UK.'}, {'ForeName': 'Lindsy', 'Initials': 'L', 'LastName': 'Forbess', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Shouichi', 'Initials': 'S', 'LastName': 'Fujimoto', 'Affiliation': 'University of Miyazaki, Miyazaki, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Furuta', 'Affiliation': 'Chiba University, Chiba, Japan.'}, {'ForeName': 'Ora', 'Initials': 'O', 'LastName': 'Gewurz-Singer', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Toshiko', 'Initials': 'T', 'LastName': 'Ito-Ihara', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Khalidi', 'Affiliation': 'McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Klocke', 'Affiliation': 'Dudley Group NHS Foundation Trust, Dudley, West Midlands, UK.'}, {'ForeName': 'Curry', 'Initials': 'C', 'LastName': 'Koening', 'Affiliation': 'University of Utah Vasculitis Center, Salt Lake City, Utah, USA.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Komagata', 'Affiliation': 'Kyorin University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Langford', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, Ohio, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lanyon', 'Affiliation': 'Rheumatology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'Raashid Ahmed', 'Initials': 'RA', 'LastName': 'Luqmani', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Science (NDORMs), University of Oxford, Oxford, UK.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Makino', 'Affiliation': 'Okayama Universty Hospital, Okayama, Japan.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'McAlear', 'Affiliation': 'Division of Rheumatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monach', 'Affiliation': 'Division of Rheumatology, VA Boston Healthcare System, West Roxbury, Massachusetts, USA.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Moreland', 'Affiliation': 'University of Pittsburg, Pittsburg, Pennsylvania, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Mynard', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Nachman', 'Affiliation': 'University of North Carolina, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pagnoux', 'Affiliation': 'Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Pearce', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, Nottingham, UK.'}, {'ForeName': 'Chen Au', 'Initials': 'CA', 'LastName': 'Peh', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Pusey', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Dwarakanathan', 'Initials': 'D', 'LastName': 'Ranganathan', 'Affiliation': ""Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Rennie L', 'Initials': 'RL', 'LastName': 'Rhee', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Spiera', 'Affiliation': 'HSS, New York, New York, USA.'}, {'ForeName': 'Antoine G', 'Initials': 'AG', 'LastName': 'Sreih', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Tesar', 'Affiliation': 'Department of Nephrology, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Walters', 'Affiliation': 'Canberra Hospital, Canberra, Australian Capital Territory, Australia.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Weisman', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Wroe', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, Middlesbrough, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Merkel', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2019-216863']
1340,32583567,The efficacy and safety of neoadjuvant chemotherapy on patients with advanced gastric cancer: A multicenter randomized clinical trial.,"OBJECTIVES


Exploring the efficacy and safety of perioperative chemotherapy on patients with AGC at different clinical and pathological stages.
METHODS


A phase III randomized, multicenter, trial comparing adjuvant (arm A) or perioperative S-1 plus oxaliplatin (SOX, arm B), and perioperative capecitabine plus oxaliplatin (XELOX, arm C) was initiated in T3/4, node + gastric cancer patients (unclear). Each patient received an 8-cycle chemotherapy (3 weeks for one cycle). Group arms B and C received two cycles preoperatively, and six cycles postoperatively. Primary endpoints were R0 resection rate and DFS, and secondary endpoints included OS, ORR, DCR, and safety. This study was registered on Clinicaltrials.gov. NCT01516944.
RESULTS


A total of 749 patients were randomly assigned into groups A, B, and C. Group A received 1460 circles chemotherapy and group B received 1177 circles while group C received 1200 circles. R0 resection rates in the three groups were 81.7%, 88.7%, and 83.1%, respectively. The difference between groups A and B was considered to be statistically significant (P = .018), and no significant difference between groups B and C (P = .051). Hazard ratio were compared between groups B and C and DFS showed 0.72 (0.67-0.77 with 95% CI), P non-inferiority   < .0001, P log-rank   = .064). The CI top limit actually lower than the estimated value of 1.38, which indicated noninferiority of SOX to XELOX.
CONCLUSIONS


Compared with PAC, perioperative chemotherapy showed a significant improvement in R0 resection rates and prognosis in AGC patients with higher safety rates. This study was powered to show superiority of perioperative over adjuvant SOX, and noninferiority of SOX to XELOX. Volume measurement, repeated laparoscopic exploration combined with exfoliative cytology can be used as a supplementary method in the clinical staging and efficacy evaluation of AGC.",2020,"Compared with PAC, perioperative chemotherapy showed a significant improvement in R0 resection rates and prognosis in AGC patients with higher safety rates.","['749 patients', 'T3/4, node\xa0+\xa0gastric cancer patients (unclear', 'patients with advanced gastric cancer', 'patients with AGC at different clinical\xa0and pathological stages']","['PAC, perioperative chemotherapy', '1460 circles chemotherapy', '8-cycle chemotherapy', 'perioperative S-1 plus oxaliplatin (SOX, arm B), and perioperative capecitabine plus oxaliplatin (XELOX, arm C', 'laparoscopic exploration combined with exfoliative cytology', 'perioperative chemotherapy', 'neoadjuvant chemotherapy']","['R0 resection rates', 'R0 resection rate and DFS, and secondary endpoints included OS, ORR, DCR, and safety', 'efficacy and safety', 'R0 resection rates and prognosis', 'Hazard ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C1302181', 'cui_str': 'Chemotherapy cycle'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205226', 'cui_str': 'Exfoliative'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",749.0,0.161197,"Compared with PAC, perioperative chemotherapy showed a significant improvement in R0 resection rates and prognosis in AGC patients with higher safety rates.","[{'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Changhong', 'Initials': 'C', 'LastName': 'Lian', 'Affiliation': 'Surgical Oncology, Changzhi Medical College Affiliated Peace Hospital, Changzhi, Shanxi, China.'}, {'ForeName': 'Zhibin', 'Initials': 'Z', 'LastName': 'Huo', 'Affiliation': ""Gastrointestinal Tumor Surgery, Xingtai People's Hospital, Xingtai, China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'General Surgery, The First Hospital of Shijiazhuang, Shijiazhuang, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Liqiao', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Bibo', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Zhidong', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Honghai', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Peigang', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}]",Cancer medicine,['10.1002/cam4.3224']
1341,32585169,Effectiveness of High-Intensity Interval Training vs Moderate-Intensity Continuous Training in Patients With Fibromyalgia: A Pilot Randomized Controlled Trial.,"OBJECTIVE


To compare the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) combined with strengthening and stretching exercises in patients with fibromyalgia.
DESIGN


Interventional, single-blind, randomized controlled trial.
SETTING


Outpatient rehabilitation center.
PARTICIPANTS


Women with fibromyalgia (N=60) were randomized to HIIT, MICT, and control groups.
INTERVENTIONS


HIIT included a 5-minute warm-up at 50% of peak heart rate and 4 cycles of 4 minutes at 80%-95% of peak heart rate followed by 3-minute recovery intervals at 70% of peak heart rate. MICT consisted of 45 minutes at 65%-70% of peak heart rate. Each aerobic training session was followed by standardized strengthening and stretching exercises. The programs performed using cycle ergometers for 5 sessions per week for 6 weeks. The control group did not participate in any supervised exercise sessions.
MAIN OUTCOME MEASURES


The primary outcome measure was the Fibromyalgia Impact Questionnaire (FIQ). The secondary outcome measures were visual analog scale for pain, Short Form-36 Health Survey (SF-36), cardiopulmonary exercise test (CPET), and body composition parameters.
RESULTS


Fifty-five participants completed the study. There was no significant difference in FIQ between HIIT vs MICT (1.03; 95% CI, -9.67 to 11.75) after treatment. Group-time interactions were significant for the FIQ between interventions and control (HIIT vs control, -16.20; 95% CI, -27.23 to -5.13 and MICT vs control, -17.24; 95% CI, -28.27 to -6.22) (all P<.001). There were significant group-time interactions for the pain, SF-36, and CPET parameters between treatments and control (all P<.05). Body weight, fat percentage, fat mass, and body mass index improved significantly (all P<.05) only in the MICT group after treatment.
CONCLUSIONS


The HIIT plus strengthening and stretching exercises and MICT plus strengthening and stretching exercises interventions showed significant improvements for the effect of fibromyalgia, pain degree, functional capacity, and quality of life compared with the control group. HIIT was not superior to MICT. Furthermore, body composition parameters were improved significantly only for the MICT group.",2020,"The HIIT plus strengthening and stretching exercises and MICT plus strengthening and stretching exercises interventions showed significant improvements for the impact of fibromyalgia, pain degree, functional capacity and quality of life compared to the control group.","['Fifty-five participants completed the study', 'patients with fibromyalgia', 'Outpatient rehabilitation center', 'Sixty women diagnosed with fibromyalgia']","['high-intensity interval training versus moderate-intensity continuous training', 'HIIT, MICT', 'MICT', 'high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) combined with strengthening and stretching exercises', 'supervised exercise sessions', 'stretching exercises and MICT plus strengthening and stretching exercises interventions']","['Body-weight, fat-percentage, fat-mass and body mass index', 'fibromyalgia, pain degree, functional capacity and quality of life', 'visual analogic scale for pain, Short Form Health Survey-36 (SF-36), cardiopulmonary exercise test (CPET) and body composition parameters', 'body composition parameters', 'pain, SF-36 and CPET parameters', 'FIQ', 'Fibromyalgia Impact Questionnaire (FIQ']","[{'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",60.0,0.131849,"The HIIT plus strengthening and stretching exercises and MICT plus strengthening and stretching exercises interventions showed significant improvements for the impact of fibromyalgia, pain degree, functional capacity and quality of life compared to the control group.","[{'ForeName': 'Tuğba', 'Initials': 'T', 'LastName': 'Atan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Gaziler Physical Therapy and Rehabilitation Education and Research Hospital, Ankara. Electronic address: tubaatan@gmail.com.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Karavelioğlu', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Hitit University, Corum, Turkey.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.05.022']
1342,32585185,"Effectiveness of a brief lay counsellor-delivered, problem-solving intervention for adolescent mental health problems in urban, low-income schools in India: a randomised controlled trial.","BACKGROUND


Mental health problems are a leading cause of disability in adolescents worldwide. Problem solving is a well-tested mental health intervention in many populations. We aimed to investigate the effectiveness of a brief, transdiagnostic problem-solving intervention for common adolescent mental health problems when delivered by non-specialist school counsellors in New Delhi, India.
METHODS


This randomised trial was done in six government-run schools (three all-boys schools, two all-girls schools, and one co-educational school) that serve low-income communities. We recruited participants from grades 9 to 12 (ages 12-20 years) by selecting students with persistently elevated mental health symptoms accompanied by distress or functional impairment. Clinical eligibility criteria were assessed by research assistants using the Hindi-language version of the Strengths and Difficulties Questionnaire (SDQ), with reference to locally validated borderline cutoff scores of 19 or greater for boys and 20 or greater for girls on the SDQ Total Difficulties scale, an abnormal score of 2 or more on the SDQ Impact scale, and persistence of more than 1 month on the SDQ Chronicity index. Participants were randomly allocated (1:1) to problem solving delivered through a brief (2-3 week) counsellor-led intervention with supporting printed materials (intervention group), or problem solving delivered via printed booklets alone (control group). Primary outcomes were adolescent-reported mental health symptoms (SDQ Total Difficulties scale) and idiographic psychosocial problems (Youth Top Problems [YTP]) at 6 weeks. Primary analyses were done on an intention-to-treat basis at the 6-week endpoint. The trial is registered with ClinicalTrials.gov, NCT03630471.
FINDINGS


Participants were enrolled between Aug 20, and Dec 4, 2018. 283 eligible adolescents were referred to the trial, and 251 (89%) of these were enrolled (mean age 15·61 years; 174 [69%] boys). 125 participants were allocated to each group (after accounting for one participant in the intervention group who withdrew consent after randomisation). Primary outcome data were available for 245 (98%) participants. At 6 weeks, the mean YTP scores were 3·52 (SD 2·66) in the intervention group and 4·60 (2·75) in the control group (adjusted mean difference -1·01, 95% CI -1·63 to -0·38; adjusted effect size 0·36, 95% CI 0·11 to 0·61; p=0·0015). The mean SDQ Total Difficulties scores were 17·48 (5·45) in the intervention group and 18·33 (5·45) in the control group (-0·86, -2·14 to 0·41; 0·16, -0·09 to 0·41; p=0·18). We observed no adverse events.
INTERPRETATION


A brief lay counsellor-delivered problem-solving intervention combined with printed booklets seemed to have a modest effect on psychosocial outcomes among adolescents with diverse mental health problems compared with problem-solving booklets alone. This counsellor-delivered intervention might be a suitable first-line intervention in a stepped care approach, which is being evaluated in ongoing studies.
FUNDING


Wellcome Trust.",2020,"At 6 weeks, the mean YTP scores were 3·52 (SD 2·66) in the intervention group and 4·60 (2·75) in the control group (adjusted mean difference -1·01, 95% CI -1·63 to -0·38; adjusted effect size 0·36, 95% CI 0·11 to 0·61;","['125 participants', 'adolescent mental health problems in urban, low-income schools in India', 'common adolescent mental health problems when delivered by non-specialist school counsellors in New Delhi, India', '283 eligible adolescents were referred to the trial, and 251 (89%) of these were enrolled (mean age 15·61 years; 174 [69%] boys', 'adolescents with diverse mental health problems', 'participants from grades 9 to 12 (ages 12-20 years) by selecting students with persistently elevated mental health symptoms accompanied by distress or functional impairment', 'six government-run schools (three all-boys schools, two all-girls schools, and one co-educational school) that serve low-income communities', 'Participants were enrolled between Aug 20, and Dec 4, 2018']","['problem solving delivered through a brief (2-3 week) counsellor-led intervention with supporting printed materials (intervention group), or problem solving delivered via printed booklets alone (control group', 'lay counsellor-delivered problem-solving intervention combined with printed booklets', 'brief lay counsellor-delivered, problem-solving intervention', 'transdiagnostic problem-solving intervention']","['SDQ Total Difficulties scale', 'SDQ Chronicity index', 'psychosocial outcomes', 'mean YTP scores', 'mean SDQ Total Difficulties scores', 'adolescent-reported mental health symptoms (SDQ Total Difficulties scale) and idiographic psychosocial problems (Youth Top Problems [YTP']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0557802', 'cui_str': 'Specialist school'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0086541', 'cui_str': 'Dry form of cutaneous leishmaniasis'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0033211', 'cui_str': 'Problem solving'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0034036', 'cui_str': 'Printed material'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0547045', 'cui_str': 'Chronicity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]",125.0,0.178681,"At 6 weeks, the mean YTP scores were 3·52 (SD 2·66) in the intervention group and 4·60 (2·75) in the control group (adjusted mean difference -1·01, 95% CI -1·63 to -0·38; adjusted effect size 0·36, 95% CI 0·11 to 0·61;","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': 'School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Kanika', 'Initials': 'K', 'LastName': 'Malik', 'Affiliation': 'Sagath, New Delhi, India.'}, {'ForeName': 'Rachana', 'Initials': 'R', 'LastName': 'Parikh', 'Affiliation': 'Sagath, New Delhi, India; Department of Clinical Psychology, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'Medical Research Council Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Aoife M', 'Initials': 'AM', 'LastName': 'Doyle', 'Affiliation': 'Medical Research Council Tropical Epidemiology Group, Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Bhargav', 'Initials': 'B', 'LastName': 'Bhat', 'Affiliation': 'Sangath, Goa, India.'}, {'ForeName': 'Rooplata', 'Initials': 'R', 'LastName': 'Sahu', 'Affiliation': 'Sagath, New Delhi, India.'}, {'ForeName': 'Bhagwant', 'Initials': 'B', 'LastName': 'Chilhate', 'Affiliation': 'Sagath, New Delhi, India.'}, {'ForeName': 'Sonal', 'Initials': 'S', 'LastName': 'Mathur', 'Affiliation': 'Sagath, New Delhi, India.'}, {'ForeName': 'Madhuri', 'Initials': 'M', 'LastName': 'Krishna', 'Affiliation': 'Sagath, New Delhi, India.'}, {'ForeName': 'Rhea', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Sagath, New Delhi, India.'}, {'ForeName': 'Paulomi', 'Initials': 'P', 'LastName': 'Sudhir', 'Affiliation': 'Department of Clinical Psychology, National Institute of Mental Health and Neuro Sciences, Bengaluru, India.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Division of Psychiatry, Faculty of Brain Sciences, University College London, London, UK.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical Psychology, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Chorpita', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Fairburn', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA; Harvard TH Chan School of Public Health, Boston, MA, USA. Electronic address: vikram_patel@hms.harvard.edu.'}]",The Lancet. Child & adolescent health,['10.1016/S2352-4642(20)30173-5']
1343,32586429,Effectiveness of an mHealth Intervention for Infant Sleep Disturbances.,"Bedtime problems and night wakings are highly prevalent in infants. This study assessed the real-world effectiveness of an mHealth behavioral sleep intervention (Customized Sleep Profile; CSP). Caregivers (83.9% mothers) of 404 infants (age 6 to 11.9 m, M = 8.32 m, 51.2% male) used the CSP (free and publicly available behavioral sleep intervention delivered via smartphone application, Johnson's® Bedtime® Baby Sleep App). Caregivers completed the Brief Infant Sleep Questionnaire-Revised (BISQ-R) at baseline and again 4 to 28 days later. Changes in sleep patterns were analyzed, based on sleep problem status (problem versus no problem sleepers; PS; NPS). Sleep onset latency improved in both groups. Earlier bedtimes, longer continuous stretches of sleep, as well as decreased number and duration of night wakings, were evident in the PS group only. The BISQ-R Total score, total nighttime sleep, and total 24-hour sleep time improved for both groups, with a greater change for the PS group. Further, caregivers of infants in the PS group decreased feeding (bedtime and overnight) and picking up overnight, and perceived better sleep. Bedtime routine regularity, bedtime difficulty, sleep onset difficulty, and caregiver confidence improved for both groups, with the PS group showing a greater magnitude of change. Thus, a real-world, publicly available, mHealth behavioral sleep intervention was associated with improved outcomes for older infants. Intervention recommendations resulted in changes in caregivers' behavior and improvements in caregiver-reported sleep outcomes in infants, in as few as 4 days.",2020,"The BISQ-R Total score, total nighttime sleep, and total 24-hour sleep time improved for both groups, with a greater change for the PS group.","['Caregivers (83.9% mothers) of 404 infants (age 6 to 11.9 m', 'Infant Sleep Disturbances', 'older infants']","['mHealth behavioral sleep intervention (Customized Sleep Profile; CSP', ""CSP (free and publicly available behavioral sleep intervention delivered via smartphone application, Johnson's® Bedtime® Baby Sleep App"", 'mHealth Intervention']","[""caregivers' behavior and improvements in caregiver-reported sleep outcomes"", 'Bedtime routine regularity, bedtime difficulty, sleep onset difficulty, and caregiver confidence', 'BISQ-R Total score, total nighttime sleep, and total 24-hour sleep time', 'feeding (bedtime and overnight) and picking up overnight, and perceived better sleep', 'number and duration of night wakings', 'Bedtime problems and night wakings', 'Brief Infant Sleep Questionnaire-Revised (BISQ-R', 'Sleep onset latency']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010701', 'cui_str': 'Phyllodes tumour'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}]",404.0,0.0378914,"The BISQ-R Total score, total nighttime sleep, and total 24-hour sleep time improved for both groups, with a greater change for the PS group.","[{'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Leichman', 'Affiliation': ""Saint Joseph's University. Electronic address: erin.leichman@sju.edu.""}, {'ForeName': 'Russell A', 'Initials': 'RA', 'LastName': 'Gould', 'Affiliation': 'Johnson & Johnson Consumer Inc.'}, {'ForeName': 'Ariel A', 'Initials': 'AA', 'LastName': 'Williamson', 'Affiliation': ""Children's Hospital of Philadelphia.""}, {'ForeName': 'Russel M', 'Initials': 'RM', 'LastName': 'Walters', 'Affiliation': 'Johnson & Johnson Consumer Inc.'}, {'ForeName': 'Jodi A', 'Initials': 'JA', 'LastName': 'Mindell', 'Affiliation': ""Saint Joseph's University; Children's Hospital of Philadelphia.""}]",Behavior therapy,['10.1016/j.beth.2019.12.011']
1344,32586643,Axial or Helical? CT imaging of the thorax for dyspnoea patients with free-breathing using 16 cm wide-detector CT.,"AIM


To compare image quality and radiation dose between fast-helical mode (FHM) and two-axial mode (TAM) in chest computed tomography (CT) with 16 cm wide-detector for emergency patients with dyspnoea.
MATERIALS AND METHODS


Ninety-six emergency chest CT patients who cannot comply with breathing instructions were prospectively divided randomly into two groups: the FHM group (n=48, helical scan with 80 mm collimation and pitch 0.992:1), the TAM group (n=48, two axial scans with 160 mm collimation). Both groups used 0.28 seconds rotation speed and automatic tube current modulation. All scans were performed in free breathing. CT value, image noise, and signal-to-noise ratio (SNR) were measured on the descending thoracic aorta, lung parenchyma, and paraspinal muscle at the carina level. Two radiologists assessed images for subjective image quality, motion artefacts and diagnostic confidence. The volume CT dose index and dose-length product (DLP) were evaluated and effective dose (ED) was calculated.
RESULTS


The TAM group required less exposure time than the FHM group (0.56 versus 1.14 seconds, p<0.001), reduced the frequency of motion artefacts caused by the diaphragm and heart by 50% and provided higher diagnostic confidence score (3.83 versus 3.58, p<0.05). TAM resulted in 24% lower DLP (96.76±31.58 versus 126.99±33.37 mGy·cm) and ED (1.36±0.44 versus 1.78±0.47 mSv) than FHM (p<0.001), but there was no difference in the CT value, image noise, and SNR between the two groups (p>0.05).
CONCLUSIONS


TAM with 16 cm detector coverage further reduces the exposure time in chest CT for dyspnoea patients and ensures good image quality with 24% radiation dose reduction, compared with fast-helical chest CT with 80 mm collimation.",2020,"The TAM group required less exposure time than the FHM group (0.56 versus 1.14 seconds, p<0.001), reduced the frequency of motion artefacts caused by the diaphragm and heart by 50% and provided higher diagnostic confidence score (3.83 versus 3.58, p<0.05).","['emergency patients with dyspnoea', 'Ninety-six emergency chest CT patients who cannot comply with breathing instructions', 'dyspnoea patients with free-breathing using 16 cm wide-detector CT']","['FHM group (n=48, helical scan with 80 mm collimation and pitch 0.992:1), the TAM', 'fast-helical mode (FHM) and two-axial mode (TAM', 'FHM', 'TAM']","['exposure time', 'CT value, image noise, and SNR', 'subjective image quality, motion artefacts and diagnostic confidence', 'DLP', 'frequency of motion artefacts', 'CT value, image noise, and signal-to-noise ratio (SNR', 'volume CT dose index and dose-length product (DLP', 'diagnostic confidence score']","[{'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332464', 'cui_str': 'Widening'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0454169', 'cui_str': 'Collimator'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0205131', 'cui_str': 'Axial'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",96.0,0.0240973,"The TAM group required less exposure time than the FHM group (0.56 versus 1.14 seconds, p<0.001), reduced the frequency of motion artefacts caused by the diaphragm and heart by 50% and provided higher diagnostic confidence score (3.83 versus 3.58, p<0.05).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China.""}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'GE Healthcare, Computed Tomography Research Center, Beijing, 100176, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China. Electronic address: yj1118@mail.xjtu.edu.cn.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, 710061, China. Electronic address: xjyjsz@163.com.""}]",Clinical radiology,['10.1016/j.crad.2020.05.014']
1345,32590151,Cryoballoon ablation of pulmonary veins for persistent atrial fibrillation: Results from the multicenter STOP Persistent AF trial.,"BACKGROUND


Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation to treat patients with symptomatic drug-refractory atrial fibrillation (AF).
OBJECTIVE


The purpose of this study was to assess the safety and efficacy of PVI using the cryoballoon catheter to treat patients with persistent AF.
METHODS


STOP Persistent AF (ClinicalTrials.gov Identifier: NCT03012841) was a prospective, multicenter, single-arm, Food and Drug Administration-regulated trial designed to evaluate the safety and efficacy of PVI-only cryoballoon ablation for drug-refractory persistent AF (continuous episodes <6 months). The primary efficacy endpoint was 12-month freedom from ≥30 seconds of AF, atrial flutter (AFL), or atrial tachycardia (AT) after a 90-day blanking period. The prespecified performance goals were set at >40% and <13% for the primary efficacy and safety endpoints, respectively. Secondary endpoints assessed quality of life using the AFEQT (Atrial Fibrillation Effect on Quality of Life) and SF (Short Form)-12 questionnaires.
RESULTS


Of 186 total enrollments, 165 subjects (70% male; age 65 ± 9 years; left atrial diameter 4.2 ± 0.6 cm; body mass index 31 ± 6) were treated at 25 sites in the United States, Canada, and Japan. Total procedural, left atrial dwell, and fluoroscopy times were 121 ± 46 minutes, 102 ± 41 minutes, and 19 ± 16 minutes, respectively. At 12 months, the primary efficacy endpoint was 54.8% (95% confidence [CI] 46.7%-62.1%) freedom from AF, AFL, or AT. There was 1 primary safety event, translating to a rate of 0.6% (95% CI 0.1%-4.4%). AFEQT and SF-12 assessments demonstrated significant improvements from baseline to 12 months postablation (P <.001).
CONCLUSION


The STOP Persistent AF trial demonstrated cryoballoon ablation to be safe and effective in treating patients with drug-refractory persistent AF characterized by continuous AF episodes <6 months.",2020,"AFEQT and SF-12 assessments demonstrated significant improvements from baseline to 12 months post ablation (P<0.001).
","['Persistent Atrial Fibrillation', 'patients with symptomatic drug-refractory atrial fibrillation (AF', 'Of 186 total enrollments, 165 subjects (70% male, 65±9 years, left atrial diameter 4.2±0.6 cm, body mass index 31±6) were treated at 25 sites in the United States, Canada, and Japan']","['Cryoballoon Ablation of Pulmonary Veins', 'Pulmonary vein isolation (PVI', 'PVI-only cryoballoon ablation for drug-refractory persistent AF', 'PVI']","['Total procedure, left atrial dwell, and fluoroscopy times', 'safety and efficacy', 'quality of life using the AFEQT and SF-12 questionnaires', '12-month freedom from ≥30 sec of AF, atrial flutter (AFL), or atrial tachycardia (AT']","[{'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0034090', 'cui_str': 'Structure of vein of pulmonary circulation'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}]",,0.0320406,"AFEQT and SF-12 assessments demonstrated significant improvements from baseline to 12 months post ablation (P<0.001).
","[{'ForeName': 'Wilber W', 'Initials': 'WW', 'LastName': 'Su', 'Affiliation': 'Banner University Medical Center Phoenix, Phoenix, Arizona.'}, {'ForeName': 'Vivek Y', 'Initials': 'VY', 'LastName': 'Reddy', 'Affiliation': 'Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Kabir', 'Initials': 'K', 'LastName': 'Bhasin', 'Affiliation': 'Northwell Health-Lenox Hill Heart and Lung, New York, New York.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Champagne', 'Affiliation': 'Institut Universitaire de Cardiologie et du Pneumologie de Quebec, Quebec, Canada.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Sangrigoli', 'Affiliation': 'Doylestown Cardiology Associates, Doylestown, Pennsylvania.'}, {'ForeName': 'Kendra M', 'Initials': 'KM', 'LastName': 'Braegelmann', 'Affiliation': 'Medtronic, Inc., Minneapolis, Minnesota.'}, {'ForeName': 'Fred J', 'Initials': 'FJ', 'LastName': 'Kueffer', 'Affiliation': 'Medtronic, Inc., Minneapolis, Minnesota.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': 'Royal Jubilee Hospital, Victoria, Canada.'}, {'ForeName': 'Sanjaya K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': ""Saint Luke's Health System, Kansas City, Missouri.""}, {'ForeName': 'Teiichi', 'Initials': 'T', 'LastName': 'Yamane', 'Affiliation': 'Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Calkins', 'Affiliation': 'Johns Hopkins Medical Institutions, Baltimore, Maryland. Electronic address: hcalkins@jhmi.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Heart rhythm,['10.1016/j.hrthm.2020.06.020']
1346,32442118,"Effects of Kinesio Taping on pain, paresthesia, functional status, and overall health status in patients with symptomatic thoracic outlet syndrome: A single-blind, randomized, placebo-controlled study.","OBJECTIVE


This study aimed to assess the effects of kinesio taping (KT) on pain, paresthesia, functional status, and overall health status in patients with symptomatic thoracic outlet syndrome (sTOS).
METHODS


A single-blind placebo-controlled design was employed in this study. The study duration was defined as 12 months. Analyses were performed on 60 patients with sTOS randomly assigned to KT (4 men and 26 women; mean age=33.5 years, range=20-46 years) and control groups (5 men and 25 women; mean age=26 years, range=20-43 years). KT was applied to the KT group three times. The control group received placebo taping. Pain and paresthesia were evaluated using the visual analogue scale (VAS) pain (10 cm) and VAS paresthesia (10 cm). The upper limb function was assessed using the disabilities of the arm, shoulder, and hand (DASH) questionnaire. The overall health status was evaluated based on the Nottingham Health Profile (NHP). Each assessment was carried out at baseline (t0), posttreatment (t1), and 8 weeks after baseline (t2).
RESULTS


In the KT group, except the social isolation domain of the NHP, all outcome measures showed improvement from t0 to t1. At the second follow-up visit (t2), improvements remained visible compared with baseline. However, none of the variables improved from t1 to t2. Otherwise, all measures deteriorated slightly, and the deteriorations in VAS for pain, NHP pain, NHP sleep, and NHP physical abilities were statistically significant (p=0.041, p=0.048, p=0.013, and p=0.016, respectively). In the control group, only VAS for paresthesia and NHP emotional reaction showed improvement over time (p=0.002 and p=0.044, respectively). When changes in outcome measures between the two groups were compared, except NHP emotional reaction and NHP social isolation, median changes (from t0 to t1) were higher in the KT group than in the control group (p<0.05 for all variables). Regarding VAS pain, VAS paresthesia, DASH, and three NHP domains (energy level, pain, and physical abilities), changes from t0 to t2 were also higher in the KT group (p<0.05 for all variables).
CONCLUSION


KT can provide benefits in terms of relieving pain and paresthesia, as well as improving the upper limb function and quality of life in patients with sTOS.
LEVEL OF EVIDENCE


Level II, Therapeutic study.",2020,"In the KT group, except the social isolation domain of the NHP, all outcome measures showed improvement from t0 to t1.","['patients with symptomatic thoracic outlet syndrome', '60 patients with sTOS randomly assigned to KT (4 men and 26 women; mean age=33.5 years, range=20-46 years) and control groups (5 men and 25 women; mean age=26 years, range=20-43 years', 'patients with sTOS', 'patients with symptomatic thoracic outlet syndrome (sTOS']","['placebo', 'kinesio taping (KT', 'placebo taping', 'kinesio taping']","['deteriorations in VAS for pain, NHP pain, NHP sleep, and NHP physical abilities', 'disabilities of the arm, shoulder, and hand (DASH) questionnaire', 'upper limb function', 'VAS for paresthesia and NHP emotional reaction', 'Pain and paresthesia', 'overall health status', 'VAS pain, VAS paresthesia, DASH, and three NHP domains (energy level, pain, and physical abilities', 'except NHP emotional reaction and NHP social isolation, median changes', 'pain, paresthesia, functional status, and overall health status', 'visual analogue scale (VAS) pain (10 cm) and VAS paresthesia', 'upper limb function and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039984', 'cui_str': 'Thoracic outlet syndrome'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451339', 'cui_str': 'Nottingham health profile'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0221736', 'cui_str': 'Reaction emotional'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0325014,"In the KT group, except the social isolation domain of the NHP, all outcome measures showed improvement from t0 to t1.","[{'ForeName': 'Emine Aygül', 'Initials': 'EA', 'LastName': 'Ortaç', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Çukurova University, School of Medicine, Adana, Turkey.'}, {'ForeName': 'Tunay', 'Initials': 'T', 'LastName': 'Sarpel', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Çukurova University, School of Medicine, Adana, Turkey.'}, {'ForeName': 'İlke Coşkun', 'Initials': 'İC', 'LastName': 'Benlidayı', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Çukurova University, School of Medicine, Adana, Turkey.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.19042']
1347,32444230,"The Impact of Epinephrine in the Periarticular Injection Cocktail using Ropivacaine for Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind Comparison Study.","BACKGROUND


Epinephrine is used in periarticular injection using ropivacaine to produce a synergistic effect when used with local anesthetic agents but the effect has not been proven yet. The purpose of this study is to evaluate how effective epinephrine is on postoperative clinical outcomes in primary total knee arthroplasty (TKA).
METHODS


One hundred sixteen cases (89 patients) who underwent primary TKA were randomized into 2 groups depending on whether epinephrine was mixed. Immediately after the operation, patient-controlled analgesia using fentanyl was initiated. The Numerical Rating Scale, the cumulative dose of fentanyl, active range of motion of the knee joint, and wound complications were evaluated postoperatively.
RESULTS


There were no significant differences in mean postoperative Numerical Rating Scale, cumulative dose of fentanyl, and active range of motion between the 2 groups. Neither skin necrosis nor wound dehiscence requiring operative management for skin care was required in either group.
CONCLUSION


The use of epinephrine in periarticular injection using ropivacaine after TKA did not have any effect on postoperative acute pain control and opioid usage.
THE LEVEL OF EVIDENCE


Therapeutic level I.",2020,"There were no significant differences in mean postoperative Numerical Rating Scale, cumulative dose of fentanyl, and active range of motion between the 2 groups.","['One hundred sixteen cases (89 patients) who underwent primary TKA', 'Total Knee Arthroplasty', 'primary total knee arthroplasty (TKA']","['ropivacaine', 'Epinephrine', 'Ropivacaine', 'epinephrine']","['postoperative acute pain control and opioid usage', 'Numerical Rating Scale, the cumulative dose of fentanyl, active range of motion of the knee joint, and wound complications', 'mean postoperative Numerical Rating Scale, cumulative dose of fentanyl, and active range of motion']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1171175', 'cui_str': 'Acute pain control'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",116.0,0.16959,"There were no significant differences in mean postoperative Numerical Rating Scale, cumulative dose of fentanyl, and active range of motion between the 2 groups.","[{'ForeName': 'Dong Yi', 'Initials': 'DY', 'LastName': 'Kong', 'Affiliation': 'Department of Orthopaedic Surgery, Juan Nanoori Hospital, Incheon, South Korea.'}, {'ForeName': 'Jeong Han', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Department of Orthopaedic Surgery, HeeMyoung General Hospital, Seoul, South Korea.'}, {'ForeName': 'Won Rak', 'Initials': 'WR', 'LastName': 'Choi', 'Affiliation': 'Department of Orthopaedic Surgery, Hanyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young-Il', 'Initials': 'YI', 'LastName': 'Ko', 'Affiliation': 'Department of Orthopaedic Surgery, Hanyang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Choong H', 'Initials': 'CH', 'LastName': 'Choi', 'Affiliation': 'Department of Orthopaedic Surgery, Hanyang University College of Medicine, Seoul, South Korea.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.04.042']
1348,32580074,Impact of electrical cardioversion on quality of life for patients with symptomatic persistent atrial fibrillation: Is there a treatment expectation effect?,"It is assumed that electrical cardioversion (ECV) improves the quality of life (QoL) of patients with atrial fibrillation (AF) by restoring sinus rhythm (SR).
OBJECTIVE


We examined the effect of ECV and rhythm status on QoL of patients with symptomatic persistent AF in a randomized controlled trial.
METHOD


The elective cardioversion for prevention of symptomatic atrial fibrillation trial examined the efficacy of dronedarone around the time of ECV in maintaining SR. Quality of life was measured with the University of Toronto Atrial Fibrillation Severity Scale. The primary outcome was the change in AF symptom severity (∆AFSS) score over 6 months (0-35 points, with higher scores reflecting worse QoL and a minimal clinically important difference defined as ∆AFSS ≥3 points). Multivariable linear regression was performed to identify factors associated with changes in QoL.
RESULTS


We included 148 patients with complete AFSS scores at baseline and 6 months. Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups). After adjustment of baseline covariates, maintenance of SR was associated with QoL improvement (ΔAFSS: -3.8 points, 95% CI: -6.0 to -1.6 points, P < .01).
CONCLUSIONS


Maintenance of SR was associated with clinically relevant improvement in patients' QoL at 6 months. Patients with AF recurrence had a small but still relevant improvement in their QoL, potentially due to factors other than sinus rhythm.",2020,"Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups).","['Patients with AF recurrence', 'patients with symptomatic persistent atrial fibrillation', '148 patients with complete AFSS scores at baseline and 6 months', 'patients with symptomatic persistent AF', 'patients with atrial fibrillation (AF) by restoring sinus rhythm (SR']","['electrical cardioversion', 'dronedarone', 'ECV', 'electrical cardioversion (ECV']","['quality of life', 'University of Toronto Atrial Fibrillation Severity Scale', 'quality of life (QoL', 'change in AF symptom severity (∆AFSS) score', 'Quality of life', 'AF relapse', 'unsuccessful ECV', 'QoL improved irrespective of rhythm status (ΔAFSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}]","[{'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0766326', 'cui_str': 'dronedarone'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",148.0,0.042951,"Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups).","[{'ForeName': 'Andrew C T', 'Initials': 'ACT', 'LastName': 'Ha', 'Affiliation': 'Peter Munk Cardiac Center, University Health Network, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada. Electronic address: andrew.ha@uhn.ca.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Sanofi, Montreal, Quebec, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Klein', 'Affiliation': 'Arrhythmia Service, University Hospital, Western University, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Roy', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Koren', 'Affiliation': 'Sanofi US, Bridgewater, NJ, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorian', 'Affiliation': ""Department of Medicine, University of Toronto, Toronto, Ontario, Canada; St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}]",American heart journal,['10.1016/j.ahj.2020.05.004']
1349,32446470,"Effect of State Immunization Information System Based Reminder/Recall for Influenza Vaccinations: A Randomized Trial of Autodialer, Text, and Mailed Messages.","OBJECTIVE


To evaluate the effect of different modalities of centralized reminder/recall (autodialer, text, mailed reminders) on increasing childhood influenza vaccination.
STUDY DESIGN


Two simultaneous randomized clinical trials conducted from October 2017 to April 1, 2018, in New York State and Colorado. There were 61 931 children in New York (136 practices) and 23 845 children in Colorado (42 practices) who were randomized to different centralized reminder/recall modalities-4 arms in New York (autodialer, text, mailed, and no reminder control) and 3 arms in Colorado (autodialer, mailed, and no reminder control). The message content was similar across modalities. Up to 3 reminders were sent for intervention arms. The main outcome measure was receipt of ≥1 influenza vaccine.
RESULTS


In New York, compared with the control arm (26.6%), postintervention influenza vaccination rates in the autodialer arm (28.0%) were 1.4 percentage points higher (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10), but the rates for text (27.6%) and mail (26.8%) arms were not different from controls. In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively. Compared with the control arm, the incremental cost per additional vaccine delivered was $20 (New York) and $16 (Colorado) for autodialer messages.
CONCLUSIONS


Centralized reminder/recall for childhood influenza vaccine was most effective via autodialer, less effective via mail, and not effective via text messages. The impact of each modality was modest. Compared with no reminders, the incremental cost per additional vaccine delivered was also modest for autodialer messages.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03294473 and NCT03246100.",2020,"In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively.","['Influenza Vaccinations', '61 931 children in New York (136 practices) and 23 845 children in Colorado (42 practices', 'October 2017 to April 1, 2018, in New York State and Colorado']","['centralized reminder/recall (autodialer, text, mailed reminders', 'centralized reminder/recall modalities-4 arms in New York (autodialer, text, mailed, and no reminder control) and 3 arms in Colorado (autodialer, mailed, and no reminder control']","['postintervention influenza vaccination rates', 'receipt of ≥1 influenza vaccine']","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]",61931.0,0.279722,"In Colorado, compared with the control arm (29.9%), postintervention influenza vaccination rates for the autodialer (32.9%) and mail (31.5%) arms were 3.0 percentage points (adjusted risk ratio, 1.08; 95% CI, 1.03-1.12) and 1.6 percentage points (adjusted risk ratio, 1.06; 95% CI, 1.02-1.10) higher, respectively.","[{'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Szilagyi', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA. Electronic address: pszilagyi@mednet.ucla.edu.""}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Albertin', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Alison W', 'Initials': 'AW', 'LastName': 'Saville', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Valderrama', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Breck', 'Affiliation': ""Department of Pediatrics, UCLA Mattel Children's Hospital, University of California at Los Angeles, Los Angeles, CA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Helmkamp', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Xinkai', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'Sitaram', 'Initials': 'S', 'LastName': 'Vangala', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'L Miriam', 'Initials': 'LM', 'LastName': 'Dickinson', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Department of Medicine, Statistics Core, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Campbell', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Whittington', 'Affiliation': 'Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Roth', 'Affiliation': 'Colorado Immunization Information System, Colorado Department of Public Health and Environment, Denver, CO.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Rand', 'Affiliation': 'Department of Pediatrics, University of Rochester School of Medicine and Dentistry, Rochester, NY.'}, {'ForeName': 'Sharon G', 'Initials': 'SG', 'LastName': 'Humiston', 'Affiliation': ""Department of Pediatrics, Children's Mercy, Kansas City, MO.""}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Hoefer', 'Affiliation': 'New York State Immunization Information System, New York State Department of Health, New York, NY.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Kempe', 'Affiliation': ""Adult and Child Consortium for Health Outcomes Research and Delivery Science (ACCORDS), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, CO; Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.02.020']
1350,32450057,Influence of Bleeding Risk on Outcomes of Radial and Femoral Access for Percutaneous Coronary Intervention: An Analysis From the GLOBAL LEADERS Trial.,"BACKGROUND


Radial artery access has been shown to reduce mortality and bleeding events, especially in patients with acute coronary syndromes. Despite this, interventional cardiologists experienced in femoral artery access still prefer that route for percutaneous coronary intervention. Little is known regarding the merits of each vascular access in patients stratified by their risk of bleeding.
METHODS


Patients from the Global Leaders trial were dichotomized into low or high risk of bleeding by the median of the PRECISE-DAPT score. Clinical outcomes were compared at 30 days.
RESULTS


In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.42-1.15). Radial access was associated with a significantly lower rate of the secondary safety end point, Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding (HR 0.55, 95% CI 0.36-0.84). Compared by bleeding risk strata, in the high bleeding score population, the primary (HR 0.47, 95% CI 0.26-0.85; P = 0.012; P interaction  = 0.019) and secondary safety (HR 0.57, 95% CI 0.35-0.95; P = 0.030; P interaction  = 0.631) end points favoured radial access. In the low bleeding score population, however, the differences in the primary and secondary safety end points between radial and femoral artery access were no longer statistically significant.
CONCLUSIONS


Our findings suggest that the outcomes of mortality or new Q-wave MI and BARC 3 or 5 bleeding favour radial access in patients with a high, but not those with a low, risk of bleeding. Because this was not a primary analysis, it should be considered hypothesis generating.",2020,"In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR]","['Percutaneous Coronary Intervention', 'patients with acute coronary syndromes', 'Patients from the Global Leaders trial were dichotomized into low or high risk of bleeding by the median of the PRECISE-DAPT score']",[],"['radial and femoral artery access', 'secondary safety end point, Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding', 'mortality and bleeding events', 'bleeding risk strata', 'mortality or new Q-wave MI and BARC 3 or 5 bleeding favour radial access', 'secondary safety', 'composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR']","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4039184', 'cui_str': 'High risk of bleeding'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0634829', 'cui_str': '1,2-dilinolenoyl-3-(4-aminobutyryl)propane-1,2,3-triol'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",[],"[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.402974,"In the overall population, there were no statistical differences between radial and femoral access in the rate of the primary end point, a composite of all-cause mortality, or new Q-wave myocardial infarction (MI) (hazard ratio [HR]","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Department of Cardiology. Xijing Hospital, Xi'an, China; Department of Cardiology, Radboud University, Nijmegen, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.""}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'Centre for Cardiovascular Research and Development, American Heart of Poland, Kostkowice, Poland; Andrzej Frycz Modrzewski Krakow University, Krakow, Poland.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Buszman', 'Affiliation': 'Centre for Cardiovascular Research and Development, American Heart of Poland, Ustron, Poland.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Cardiology Division. Department of Internal Medicine, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology. Xijing Hospital, Xi'an, China; Department of Cardiology, Radboud University, Nijmegen, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.""}, {'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiology, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Erasmus Medical Center, Erasmus University, Rotterdam, The Netherlands.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Amsterdam, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Ton', 'Initials': 'T', 'LastName': 'Slagboom', 'Affiliation': 'Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Division of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.'}, {'ForeName': 'Christoph Kurt', 'Initials': 'CK', 'LastName': 'Naber', 'Affiliation': 'Department of Cardiology and Angiology, Elisabeth-Krankenhaus Essen, Essen, Germany.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Carrie', 'Affiliation': 'Cardiology B Department, CHU Toulouse, Hôpital Rangueil, Toulouse, France.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart Center, Bad Nauheim, Germany.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ""Hôpital Bichat, l'Assistance Publique-Hôpitaux de Paris, Université Paris-Diderot, Paris, France; Royal Brompton Hospital, Imperial College, London, United Kingdom.""}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Erasmus Medical Center, Erasmus University, Rotterdam, The Netherlands; Department of Cardiology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Robert-Jan van', 'Initials': 'RV', 'LastName': 'Geuns', 'Affiliation': 'Department of Cardiology, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, United Kingdom; Department of Cardiology, National University of Ireland, Galway, Ireland. Electronic address: patrick.w.j.c.serruys@gmail.com.'}, {'ForeName': 'Aleksander', 'Initials': 'A', 'LastName': 'Zurakowski', 'Affiliation': 'Andrzej Frycz Modrzewski Krakow University, Krakow, Poland; American Heart of Poland, Chrzanow, Poland.'}]",The Canadian journal of cardiology,['10.1016/j.cjca.2020.01.029']
1351,32457373,Participatory practices at work change attitudes and behavior toward societal authority and justice.,"Generalized attitudes toward authority and justice are often conceptualized as individual differences that are resistant to enduring change. However, across two field experiments with Chinese factory workers and American university staff, small adjustments to people's experience of participation in the workplace shifted these attitudes one month later. Both experiments randomly assigned work groups to a 20-minute participatory meeting once per week for six weeks, in which the supervisor stepped aside and workers discussed problems, ideas, and goals regarding their work (vs. a status quo meeting). Across 97 work groups and 1,924 workers, participatory meetings led workers to be less authoritarian and more critical about societal authority and justice, and to be more willing to participate in political, social, and familial decision-making. These findings provide rare experimental evidence of the theoretical predictions regarding participatory democracy: that local participatory experiences can influence broader democratic attitudes and empowerment.",2020,"Across 97 work groups and 1,924 workers, participatory meetings led workers to be less authoritarian and more critical about societal authority and justice, and to be more willing to participate in political, social, and familial decision-making.",[],[],[],[],[],[],,0.0149299,"Across 97 work groups and 1,924 workers, participatory meetings led workers to be less authoritarian and more critical about societal authority and justice, and to be more willing to participate in political, social, and familial decision-making.","[{'ForeName': 'Sherry Jueyu', 'Initials': 'SJ', 'LastName': 'Wu', 'Affiliation': 'Collins Center A-415, Anderson School of Management, University of California Los Angeles, Los Angeles, CA, 90095, USA. sherry.wu@anderson.ucla.edu.'}, {'ForeName': 'Elizabeth Levy', 'Initials': 'EL', 'LastName': 'Paluck', 'Affiliation': '420 Peretsman Scully Hall, Department of Psychology, Princeton University, Princeton, NJ, 08544, USA.'}]",Nature communications,['10.1038/s41467-020-16383-6']
1352,32459643,Adherence to Blended or Face-to-Face Smoking Cessation Treatment and Predictors of Adherence: Randomized Controlled Trial.,"BACKGROUND


Blended face-to-face and web-based treatment is a promising way to deliver smoking cessation treatment. Since adherence has been shown to be an indicator of treatment acceptability and a determinant for effectiveness, we explored and compared adherence and predictors of adherence to blended and face-to-face alone smoking cessation treatments with similar content and intensity.
OBJECTIVE


The objectives of this study were (1) to compare adherence to a blended smoking cessation treatment with adherence to a face-to-face treatment; (2) to compare adherence within the blended treatment to its face-to-face mode and web mode; and (3) to determine baseline predictors of adherence to both treatments as well as (4) the predictors to both modes of the blended treatment.
METHODS


We calculated the total duration of treatment exposure for patients (N=292) of a Dutch outpatient smoking cessation clinic who were randomly assigned either to the blended smoking cessation treatment (n=130) or to a face-to-face treatment with identical components (n=162). For both treatments (blended and face-to-face) and for the two modes of delivery within the blended treatment (face-to-face vs web mode), adherence levels (ie, treatment time) were compared and the predictors of adherence were identified within 33 demographic, smoking-related, and health-related patient characteristics.
RESULTS


We found no significant difference in adherence between the blended and the face-to-face treatments. Participants in the blended treatment group spent an average of 246 minutes in treatment (median 106.7% of intended treatment time, IQR 150%-355%) and participants in the face-to-face group spent 238 minutes (median 103.3% of intended treatment time, IQR 150%-330%). Within the blended group, adherence to the face-to-face mode was twice as high as that to the web mode. Participants in the blended group spent an average of 198 minutes (SD 120) in face-to-face mode (152% of the intended treatment time) and 75 minutes (SD 53) in web mode (75% of the intended treatment time). Higher age was the only characteristic consistently found to uniquely predict higher adherence in both the blended and face-to-face groups. For the face-to-face group, more social support for smoking cessation was also predictive of higher adherence. The variability in adherence explained by these predictors was rather low (blended R 2 =0.049; face-to-face R 2 =0.076). Within the blended group, living without children predicted higher adherence to the face-to-face mode (R 2 =0.034), independent of age. Higher adherence to the web mode of the blended treatment was predicted by a combination of an extrinsic motivation to quit, a less negative attitude toward quitting, and less health complaints (R 2 =0.164).
CONCLUSIONS


This study represents one of the first attempts to thoroughly compare adherence and predictors of adherence of a blended smoking cessation treatment to an equivalent face-to-face treatment. Interestingly, although the overall adherence to both treatments appeared to be high, adherence within the blended treatment was much higher for the face-to-face mode than for the web mode. This supports the idea that in blended treatment, one mode of delivery can compensate for the weaknesses of the other. Higher age was found to be a common predictor of adherence to the treatments. The low variance in adherence predicted by the characteristics examined in this study suggests that other variables such as provider-related health system factors and time-varying patient characteristics should be explored in future research.
TRIAL REGISTRATION


Netherlands Trial Register NTR5113; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5113.",2020,"Within BSCT, adherence to the face-to-face mode was twice as high as to the web-mode.",['patients (N=292) of a Dutch outpatient smoking cessation clinic'],"['blended smoking cessation treatment (BSCT, N=162) or to a face-to-face treatment with identical ingredients', 'Blended Treatment with Face-To-Face Treatment', 'BSCT', 'blended smoking cessation treatment (BSCT) with adherence to a face-to-face treatment (F2F']","['adherence', 'adherence levels', 'negative attitude toward quitting and less health complaints']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1262620', 'cui_str': 'Negative attitude'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]",,0.0203694,"Within BSCT, adherence to the face-to-face mode was twice as high as to the web-mode.","[{'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Siemer', 'Affiliation': 'Technology, Health & Care Research Group, Saxion University of Applied Sciences, Enschede, Netherlands.'}, {'ForeName': 'Marjolein G J', 'Initials': 'MGJ', 'LastName': 'Brusse-Keizer', 'Affiliation': 'Medical School Twente, Medisch Spectrum Twente, Enschede, Netherlands.'}, {'ForeName': 'Marloes G', 'Initials': 'MG', 'LastName': 'Postel', 'Affiliation': 'Department of Psychology, Health & Technology, University of Twente, Enschede, Netherlands.'}, {'ForeName': 'Somaya', 'Initials': 'S', 'LastName': 'Ben Allouch', 'Affiliation': 'Digital Life Research Group, Amsterdam University of Applied Science, Amsterdam, Netherlands.'}, {'ForeName': 'Robbert', 'Initials': 'R', 'LastName': 'Sanderman', 'Affiliation': 'Department of Psychology, Health & Technology, University of Twente, Enschede, Netherlands.'}, {'ForeName': 'Marcel E', 'Initials': 'ME', 'LastName': 'Pieterse', 'Affiliation': 'Centre for eHealth and Well-being Research, University of Twente, Enschede, Netherlands.'}]",Journal of medical Internet research,['10.2196/17207']
1353,32460997,An international randomized phase III trial of pulse actinomycin-D versus multi-day methotrexate for the treatment of low risk gestational trophoblastic neoplasia; NRG/GOG 275.,"OBJECTIVES


Methotrexate and actinomycin-D are both effective first-line drugs for low-risk (WHO score 0-6) Gestational Trophoblastic Neoplasia (GTN) with considerable debate about which is more effective, less toxic, and better tolerated. The primary trial objective was to test if treatment with multi-day methotrexate (MTX) was inferior to pulse actinomycin-D (ACT-D). Secondary objectives included evaluation of severity and frequency of adverse events, and impact on quality of life (QOL).
METHODS


This was a prospective international cooperative group randomized phase III two arm non-inferiority study (Clinical Trials Identifier: (NCT01535053). The control arm was ACT-D; the experimental arm was multi-day MTX regimen (institutional preference of 5 or 8 day). Outcome measures included complete response rate, recurrence rate, toxicity, and QOL as measured by FACT-G and FACIT supplemental items.
RESULTS


The complete response rates for multi-day methotrexate and pulse actinomycin-D were 88% (23/26 patients) and 79% (22/28 patients) (p = NS) respectively, there were two recurrences in each arm, and 100% of patients survived. Significant toxicity was minimal, but mouth sores (mucositis), and eye pain were significantly more common in the MTX arm (p = 0.001 and 0.01 respectively). Quality of life showed no significant difference in overall quality of life, body image, sexual function, or treatment related side effects. The study was closed for low accrual rate (target 384, actual accrual 57), precluding statistical analysis of the primary objective.
CONCLUSIONS


The complete response rate for multi-day methotrexate was higher than actinomycin-D, but did not reach statistical significance. The multi-day MTX regimens were associated with significantly more mucositis and were significantly less convenient.",2020,"The complete response rate for multi-day methotrexate was higher than actinomycin-D, but did not reach statistical significance.",['low risk gestational trophoblastic neoplasia; NRG/GOG 275'],"['pulse actinomycin-D (ACT-D', 'pulse actinomycin-D versus multi-day methotrexate', 'MTX', 'multi-day methotrexate (MTX', 'Methotrexate and actinomycin-D']","['complete response rates', 'mouth sores (mucositis), and eye pain', 'mucositis', 'evaluation of severity and frequency of adverse events, and impact on quality of life (QOL', 'Significant toxicity', 'overall quality of life, body image, sexual function, or treatment related side effects', 'complete response rate, recurrence rate, toxicity, and QOL as measured by FACT-G and FACIT supplemental items', 'complete response rate']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C1135868', 'cui_str': 'Gestational trophoblastic neoplasia'}, {'cui': 'C4517676', 'cui_str': '275'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0010934', 'cui_str': 'Dactinomycin'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0149745', 'cui_str': 'Ulcer of mouth'}, {'cui': 'C0151827', 'cui_str': 'Pain in eye'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.121683,"The complete response rate for multi-day methotrexate was higher than actinomycin-D, but did not reach statistical significance.","[{'ForeName': 'Julian C', 'Initials': 'JC', 'LastName': 'Schink', 'Affiliation': 'Cancer Treatment Centers of America, Comprehensive Care and Research Center, Chicago, IL, USA. Electronic address: Julian.schink@CTCA-hope.com.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Filiaci', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: FiliaciV@NRGOncology.org.'}, {'ForeName': 'Helen Q', 'Initials': 'HQ', 'LastName': 'Huang', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: HuangH@NRGOncology.org.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tidy', 'Affiliation': 'Sheffield Teaching Hospitals, NHS Trust, Royal Hallamshire Hospital, Glossop Rd, Sheffield S10 2JF, UK. Electronic address: John.Tidy@sth.nhs.uk.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Winter', 'Affiliation': 'Sheffield Teaching Hospitals, NHS Trust, Royal Hallamshire Hospital, Glossop Rd, Sheffield S10 2JF, UK. Electronic address: matthew.winter@sth.nhs.uk.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Carter', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, 641 Lexington Avenue, New York, NY, USA. Electronic address: carterj@mskcc.org.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Anderson', 'Affiliation': 'Northwestern University, Chicago, IL, USA. Electronic address: naanders@nm.org.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Moxley', 'Affiliation': 'Oklahoma University Health Science Center, Oklahoma City, OK, USA. Electronic address: Katherine-Moxley@ouhsc.edu.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Yabuno', 'Affiliation': 'Saitama Medical University International Medical Center, Saitama, Japan. Electronic address: yabunoakira@yahoo.co.jp.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Taylor', 'Affiliation': 'Gynecologic Oncology, Magee-Womens Hospital of University of Pittsburgh Medical Center, Pittsburgh, PA, USA. Electronic address: taylorse@upmc.edu.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kushnir', 'Affiliation': ""Gynecologic Oncology, Women's Cancer Center of Nevada, Las Vegas, NV, USA. Electronic address: ckushnir@wccenter.com.""}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Horowitz', 'Affiliation': 'Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA. Electronic address: nhorowitz@partners.org.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Miller', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: david.miller@utsouthwestern.edu.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.013']
1354,32469384,Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial.,"Importance


Papillary renal cell carcinoma (PRCC) is the most common type of non-clear cell RCC. Because some cases of PRCC are MET-driven, MET inhibition could be a targeted treatment approach. In previous studies, savolitinib (AZD6094, HMPL-504, volitinib), a highly selective MET-tyrosine kinase inhibitor, demonstrated antitumor activity in this patient group.
Objective


To determine whether savolitinib is a better treatment option for this patient population, vs standard of care, sunitinib.
Design, Setting, and Participants


The SAVOIR phase 3, open-label, randomized clinical trial was a multicenter study carried out in 32 centers in 7 countries between July 2017 and the data cutoff in August 2019. Overall, 360 to 450 patients were to be screened, to randomize approximately 180 patients. Patients were adults with MET-driven (centrally confirmed), metastatic PRCC, with 1 or more measurable lesions. Exclusion criteria included prior receipt of sunitinib or MET inhibitor treatment. Overall, 254 patients were screened.
Interventions


Patients received 600 mg of savolitinib orally once daily (qd), or 50 mg of sunitinib orally qd for 4 weeks, followed by 2 weeks without treatment.
Main Outcomes and Measures


The primary end point was progression-free survival (PFS, assessed by investigator and confirmed by blinded independent central review). Secondary end points included overall survival (OS), objective response rate (ORR), duration of response, and safety/tolerability.
Results


At data cutoff, 60 patients were randomized (savolitinib n = 33; sunitinib n = 27); most patients had chromosome 7 gain (savolitinib, 30 [91%]; sunitinib, 26 [96%]) and no prior therapy (savolitinib, 28 [85%]; sunitinib, 25 [93%]). For savolitinib and sunitinib, 4 (12%) and 10 (37%) patients were women, and the median (range) age was 60 (23-78) and 65 (31-77) years, respectively. Following availability of external data on PFS with sunitinib in patients with MET-driven disease, study enrollment was closed. Progression-free survival, OS, and ORR were numerically greater with savolitinib vs sunitinib. Median PFS was not statistically different between the 2 groups: 7.0 months (95% CI, 2.8-not calculated) for savolitinib and 5.6 months (95% CI, 4.1-6.9) for sunitinib (hazard ratio [HR], 0.71; 95% CI, 0.37-1.36; P = .31). For savolitinib and sunitinib respectively, grade 3 or higher adverse events (AEs) were reported in 14 (42%) and 22 (81%) of patients and AE-related dose modifications in 10 (30%) and 20 (74%). After discontinuation, 12 (36%) and 5 (19%) of patients on savolitinib and sunitinib respectively, received subsequent anticancer therapy.
Conclusions and Relevance


Although patient numbers and follow-up were limited, savolitinib demonstrated encouraging efficacy vs sunitinib, with fewer grade 3 or higher AEs and dose modifications. Further investigation of savolitinib as a treatment option for MET-driven PRCC is warranted.
Trial Registration


ClinicalTrials.gov Identifier: NCT03091192.",2020,"Median PFS was not statistically different between the 2 groups: 7.0 months (95% CI, 2.8-not calculated) for savolitinib and 5.6 months (95% CI, 4.1-6.9) for sunitinib (hazard ratio [HR], 0.71; 95% CI, 0.37-1.36; P = .31).","['360 to 450 patients were to be screened, to randomize approximately 180 patients', 'Importance\n\n\nPapillary renal cell carcinoma ', '32 centers in 7 countries between July 2017 and the data cutoff in August 2019', '60 patients were randomized (savolitinib n\u2009=\u200933', '254 patients were screened', 'Exclusion criteria included prior receipt of sunitinib or MET inhibitor treatment', 'patients with MET-driven disease, study enrollment was closed', 'Patients were adults with MET-driven (centrally confirmed), metastatic PRCC, with 1 or more measurable lesions', 'Patients With MET-Driven Papillary Renal Cell Carcinoma']","['PRCC', 'Savolitinib vs Sunitinib']","['progression-free survival (PFS', 'Median PFS', 'overall survival (OS), objective response rate (ORR), duration of response, and safety/tolerability', 'Progression-free survival, OS, and ORR']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C1306837', 'cui_str': 'Papillary renal cell carcinoma'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.307135,"Median PFS was not statistically different between the 2 groups: 7.0 months (95% CI, 2.8-not calculated) for savolitinib and 5.6 months (95% CI, 4.1-6.9) for sunitinib (hazard ratio [HR], 0.71; 95% CI, 0.37-1.36; P = .31).","[{'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Daniel Y C', 'Initials': 'DYC', 'LastName': 'Heng', 'Affiliation': 'Department of Medical Oncology, Tom Baker Cancer Center, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Jae Lyun', 'Initials': 'JL', 'LastName': 'Lee', 'Affiliation': 'Asan Medical Center and University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Mathilde', 'Initials': 'M', 'LastName': 'Cancel', 'Affiliation': 'CHU Bretonneau Centre, Tours University, France.'}, {'ForeName': 'Remy B', 'Initials': 'RB', 'LastName': 'Verheijen', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Mellemgaard', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Lone H', 'Initials': 'LH', 'LastName': 'Ottesen', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Frigault', 'Affiliation': 'Oncology R&D, AstraZeneca, Boston, Massachusetts.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': ""L'Hernault"", 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Szijgyarto', 'Affiliation': 'Oncology R&D, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Signoretti', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Albiges', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2218']
1355,32472340,Computerized occlusal analysis of Essix and Hawley retainers used during the retention phase: a controlled clinical trial.,"AIM


The aim of this study was to evaluate the occlusal force distribution (OFD), individual tooth force (ITF), and occlusal surface area (OSA) of Essix and Hawley retainers, using T‑Scan III (Tekscan Inc., South Boston, MA, USA) analysis.
MATERIALS AND METHODS


A total of 35 subjects were randomly assigned to one of the retention groups following fixed orthodontic treatment. While 18 of these subjects were provided with Essix retainers, 17 were given Hawley retainers. Computerized occlusal analysis of the patients' dentitions was performed using T‑Scan III. The evaluations were made after debonding (T0) and at month 3 (T1), month 6 (T2) and 1 year (T3) after the retention phase.
RESULTS


The changes in OFD were significant only in the Hawley group for the left/right half jaws and the right posterior quadrants when comparing the T2-T3 time interval. Also, the differences between the groups were significant only for the left half jaw for the T0-T2 time interval and for the right half jaw when comparing the T0-T2 and the T2-T3 time intervals. The changes in ITF were insignificant within groups, but significant between the groups for tooth 11 and 22. Although there was an increase observed in OSA for both groups, the difference between the groups was insignificant. However, the OSA increase in the Essix group for the left/right anterior quadrants was significant only for the T0-T2 and the T0-T3 time intervals, while in both groups, for the posterior left quadrant, the OSA was insignificant only for the T0-T1 time interval.
CONCLUSIONS


Although OSA increased when using both retention appliances, OFD did not change.",2020,"Also, the differences between the groups were significant only for the left half jaw for the T0-T2 time interval and for the right half jaw when comparing the T0-T2 and the T2-T3 time intervals.",['A\xa0total of 35\xa0subjects'],['OSA'],"['changes in OFD', 'OSA increase', 'changes in ITF', 'occlusal force distribution (OFD), individual tooth force (ITF), and occlusal surface area (OSA) of Essix and Hawley retainers, using T‑Scan\xa0III (Tekscan Inc., South Boston, MA, USA) analysis', 'OSA']","[{'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005654', 'cui_str': 'Masticatory Force'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0242919', 'cui_str': 'Orthodontic retainer'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",,0.0329424,"Also, the differences between the groups were significant only for the left half jaw for the T0-T2 time interval and for the right half jaw when comparing the T0-T2 and the T2-T3 time intervals.","[{'ForeName': 'Özer', 'Initials': 'Ö', 'LastName': 'Alkan', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Yıldırım Beyazıt University, Ankara, Turkey.'}, {'ForeName': 'Yeşim', 'Initials': 'Y', 'LastName': 'Kaya', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Yüzüncü Yıl University, Van, Turkey. yesimkaya82@hotmail.com.'}, {'ForeName': 'Sıddık', 'Initials': 'S', 'LastName': 'Keskin', 'Affiliation': 'Department of Biostatistics, Faculty of Medicine, Yüzüncü Yıl University, Van, Turkey.'}]",Journal of orofacial orthopedics = Fortschritte der Kieferorthopadie : Organ/official journal Deutsche Gesellschaft fur Kieferorthopadie,['10.1007/s00056-020-00236-4']
1356,32470863,The effect of Korean Red Ginseng on sarcopenia biomarkers in type 2 diabetes patients.,"BACKGROUND


The elderly population is growing rapidly worldwide and sarcopenia, which is considered as a new geriatric syndrome has become an important issue. In particular, diabetes is known to be an important risk factor for sarcopenia. In this study, we investigated the effects of Korean Red Ginseng (KRG) on biomarkers of sarcopenia in middle and old age diabetes patients.
PATIENTS AND METHODS


This study was a randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to either the placebo or KRG group and took corresponding tablets for 24 weeks. The primary outcomes were changes in sarcopenia biomarkers at week 24. Secondary outcomes were changes in inflammatory and antioxidant markers and lean body mass at week 24.
RESULTS


Fifty-nine patients completed the study. Follistatin and sex hormone binding globulin (SHBG) were significantly improved in KRG group. In the subgroup analysis, female postmenopausal patients over the age of 55 showed a significant improvement in serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT) after the administration of KRG.
CONCLUSION


Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women. A further, larger population study with a longer follow-up period is warranted to verify and understand the effects of KRG on sarcopenia.",2020,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","['type 2 diabetes patients', 'Fifty-nine patients completed the study', 'middle and old age diabetes patients', 'old postmenopausal women']","['placebo or KRG', 'Korean Red Ginseng (KRG', 'KRG', 'Korean Red Ginseng', 'placebo']","['serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT', 'sarcopenia biomarkers', 'changes in inflammatory and antioxidant markers and lean body mass', 'changes in sarcopenia biomarkers', 'follistatin and SHBG levels', 'Follistatin and sex hormone binding globulin (SHBG']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}]","[{'cui': 'C0455307', 'cui_str': 'Serum sex hormone binding globulin measurement'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}]",59.0,0.135337,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","[{'ForeName': 'Kahui', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea.'}, {'ForeName': 'YuSik', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: cromoton@yuhs.ac.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: jisunn@yuhs.ac.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104108']
1357,31806216,Dabigatran Dual Therapy Versus Warfarin Triple Therapy Post-PCI in Patients With Atrial Fibrillation and Diabetes.,"OBJECTIVES


The aim of this study was to evaluate dabigatran dual therapy versus warfarin triple therapy in patients with or without diabetes mellitus in the RE-DUAL PCI (Randomized Evaluation of Dual Antithrombotic Therapy With Dabigatran Versus Triple Therapy With Warfarin in Patients With Nonvalvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial.
BACKGROUND


It is unclear whether dual therapy is as safe and efficacious as triple therapy in patients with atrial fibrillation with diabetes following percutaneous coronary intervention.
METHODS


In RE-DUAL PCI, 2,725 patients with atrial fibrillation (993 with diabetes) who had undergone PCI were assigned to warfarin triple therapy (warfarin, clopidogrel or ticagrelor, and aspirin) or dabigatran dual therapy (dabigatran 110 mg or 150 mg twice daily and clopidogrel or ticagrelor). Median follow-up was 13 months. The primary outcome was the composite of major bleeding or clinically relevant nonmajor bleeding, and the main efficacy outcome was the composite of death, thromboembolic events, or unplanned revascularization.
RESULTS


Among patients with diabetes, the incidence of major bleeding or clinically relevant nonmajor bleeding was 15.2% in the dabigatran 110 mg dual therapy group versus 27.5% in the warfarin triple therapy group (hazard ratio [HR]: 0.48; 95% confidence interval [CI] 0.35 to 0.67) and 23.8% in the dabigatran 150 mg dual therapy group versus 25.1% in the warfarin triple therapy group (HR: 0.87; 95% CI: 0.62 to 1.22). Risk for major bleeding or clinically relevant nonmajor bleeding was also reduced with both dabigatran doses among patients without diabetes (dabigatran 110 mg dual therapy: HR: 0.54; 95% CI: 0.42 to 0.70; dabigatran 150 mg dual therapy: HR: 0.63; 95% CI: 0.48 to 0.83). Risk for the efficacy endpoint was comparable between treatment groups for both patients with and those without diabetes. No interaction between treatment and diabetes subgroup could be observed, either for bleeding or for composite efficacy endpoints.
CONCLUSIONS


In this subgroup analysis, dabigatran dual therapy had a lower risk for bleeding and a comparable rate of the efficacy endpoint compared with warfarin triple therapy in patients with atrial fibrillation with or without diabetes following percutaneous coronary intervention.",2019,Risk for major bleeding or clinically relevant nonmajor bleeding was also reduced with both dabigatran doses among patients without diabetes (dabigatran 110 mg dual therapy: HR: 0.54; 95% CI: 0.42 to 0.70; dabigatran 150 mg dual therapy: HR: 0.63; 95% CI: 0.48 to 0.83).,"['patients with diabetes', '2,725 patients with atrial fibrillation (993 with diabetes) who had undergone PCI', 'Patients With Nonvalvular Atrial Fibrillation', 'Patients', 'patients with or without diabetes mellitus in the RE-DUAL PCI (Randomized Evaluation of', 'patients with atrial fibrillation with diabetes following percutaneous coronary intervention', 'patients with atrial fibrillation with or without diabetes following percutaneous coronary intervention']","['Dabigatran Dual Therapy Versus Warfarin Triple Therapy Post-PCI', 'warfarin triple therapy (warfarin, clopidogrel or ticagrelor, and aspirin) or dabigatran dual therapy (dabigatran 110\xa0mg or 150\xa0mg twice daily and clopidogrel or ticagrelor', 'Dual Antithrombotic Therapy With Dabigatran Versus Triple Therapy With Warfarin', 'warfarin triple therapy']","['composite of major bleeding or clinically relevant nonmajor bleeding, and the main efficacy outcome was the composite of death, thromboembolic events, or unplanned revascularization', 'Risk for major bleeding or clinically relevant nonmajor bleeding', 'incidence of major bleeding or clinically relevant nonmajor bleeding', 'risk for bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",2725.0,0.0743746,Risk for major bleeding or clinically relevant nonmajor bleeding was also reduced with both dabigatran doses among patients without diabetes (dabigatran 110 mg dual therapy: HR: 0.54; 95% CI: 0.42 to 0.70; dabigatran 150 mg dual therapy: HR: 0.63; 95% CI: 0.48 to 0.83).,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'Aarhus University Hospital, Aarhus, Denmark. Electronic address: michael.maeng@ki.au.dk.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'FACT, an F-CRIN Network, DHU FIRE, Hôpital Bichat, Paris, France; Université Paris Diderot, Paris, France; INSERM U_1148, Paris, France; Hôpital Bichat Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital and Heart and Vascular Center Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Johann Wolfgang Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim International, Ingelheim, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Miede', 'Affiliation': 'HMS Analytical Software, Weimar (Lahn), Germany.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital and Heart and Vascular Center Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.07.059']
1358,32482645,Tapering towards DMARD-free remission in established rheumatoid arthritis: 2-year results of the TARA trial.,"OBJECTIVES


To evaluate the 2-year clinical effectiveness of two gradual tapering strategies. The first strategy consisted of tapering the conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) first (i.e., methotrexate in ~90%), followed by the tumour necrosis factor inhibitor (TNF-inhibitor), the second strategy consisted of tapering the TNF-inhibitor first, followed by the csDMARD.
METHODS


This multicentre single-blinded randomised controlled trial included patients with rheumatoid arthritis (RA) with well-controlled disease for ≥3 consecutive months, defined as a Disease Activity Score (DAS) measured in 44 joints ≤2.4 and a swollen joint count ≤1, which was achieved with a csDMARD and a TNF-inhibitor. Eligible patients were randomised into gradual tapering the csDMARD followed by the TNF-inhibitor, or vice versa. The primary outcome was the number of disease flares. Secondary outcomes were DMARD-free remission (DFR), DAS, functional ability (Health Assessment Questionnaire Disability Index (HAQ-DI)) and radiographic progression.
RESULTS


189 patients were randomly assigned to tapering their csDMARD (n=94) or TNF-inhibitor (n=95) first. The cumulative flare rate after 24 months was, respectively, 61% (95% CI 50% to 71%) and 62% (95% CI 52% to 72%). The patients who tapered their csDMARD first were more often able to go through the entire tapering protocol and reached DFR more often than the group that tapered the TNF-inhibitor first (32% vs 20% (p=0.12) and 21% vs 10% (p=0.07), respectively). Mean DAS and HAQ-DI over time, and radiographic progression did not differ between groups (p=0.45, p=0.17, p=0.8, respectively).
CONCLUSION


The order of tapering did not affect flare rates, DAS or HAQ-DI. DFR was achievable in 15% of patients with established RA, slightly more frequent in patients that first tapered csDMARDs. Because of similar effects from a clinical viewpoint, financial arguments may influence the decision to taper TNF-inhibitors first.",2020,"Mean DAS and HAQ-DI over time, and radiographic progression did not differ between groups (p=0.45, p=0.17, p=0.8, respectively).
","['189 patients were randomly assigned to tapering their csDMARD (n=94) or', 'patients with rheumatoid arthritis (RA) with well-controlled disease for ≥3 consecutive months, defined as a Disease Activity Score (DAS) measured in 44 joints ≤2.4\u2009and a swollen joint count ≤1, which was achieved with a csDMARD and a TNF-inhibitor', 'Eligible patients']","['gradual tapering the csDMARD followed by the TNF-inhibitor, or vice versa', 'conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) first (i.e., methotrexate', 'TNF-inhibitor']","['DFR', 'flare rates, DAS or HAQ-DI', 'DMARD-free remission (DFR), DAS, functional ability (Health Assessment Questionnaire Disability Index (HAQ-DI)) and radiographic progression', 'cumulative flare rate', 'Mean DAS and HAQ-DI over time, and radiographic progression', 'number of disease flares']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0451521', 'cui_str': 'Swollen joint count'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}]","[{'cui': 'C0439833', 'cui_str': 'Gradual'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0102923', 'cui_str': 'ametantrone'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",189.0,0.0797802,"Mean DAS and HAQ-DI over time, and radiographic progression did not differ between groups (p=0.45, p=0.17, p=0.8, respectively).
","[{'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'van Mulligen', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands elise.vanmulligen@erasmusmc.nl.'}, {'ForeName': 'Angelique E', 'Initials': 'AE', 'LastName': 'Weel', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hazes', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'van der Helm-van Mil', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Pascal Hendrik Pieter', 'Initials': 'PHP', 'LastName': 'de Jong', 'Affiliation': 'Rheumatology, Erasmus MC, Rotterdam, Zuid-Holland, The Netherlands.'}]",Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-217485']
1359,32482668,Cryotherapy associated with tailored land-based exercises for knee osteoarthritis: a protocol for a double-blind sham-controlled randomised trial.,"INTRODUCTION


There is an unmet need to develop tailored therapeutic exercise protocols applying different treatment parameters and modalities for individuals with knee osteoarthritis (KOA). Cryotherapy is widely used in rehabilitation as an adjunct treatment due to its effects on pain and the inflammatory process. However, disagreement between KOA guidelines remains with respect to its recommendation status. The aim of this study is to verify the complementary effects of cryotherapy when associated with a tailored therapeutic exercise protocol for patients with KOA.
METHODS AND ANALYSIS


This study is a sham-controlled randomised trial with concealed allocation and intention-to-treat analysis. Assessments will be performed at baseline and immediately following the intervention period. To check for residual effects of the applied interventions, 3-month and 6-month follow-up assessments will be performed. Participants will be community members living with KOA divided into three groups: (1) the experimental group that will receive a tailored therapeutic exercise protocol followed by a cryotherapy session of 20 min; (2) the sham control group that will receive the same regimen as the first group, but with sham packs filled with dry sand and (3) the active treatment control group that will receive only the therapeutic exercise protocol. The primary outcome will be pain intensity according to a Visual Analogue Scale. Secondary outcomes will be the Western Ontario & McMaster Universities Osteoarthritis Index; the Short-Form Health Survey 36; the 30-s Chair Stand Test; the Stair Climb test; and the 40-m fast-paced walk test.
ETHICS AND DISSEMINATION


The trial was approved by the Institutional Ethics Committee of Federal University of São Carlos, São Paulo, Brazil. Registration approval number: CAAE: 65966617.9.0000.5504. The results will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03360500.",2020,There is an unmet need to develop tailored therapeutic exercise protocols applying different treatment parameters and modalities for individuals with knee osteoarthritis (KOA).,"['knee osteoarthritis', 'individuals with knee osteoarthritis (KOA', 'patients with KOA']","['Cryotherapy', 'tailored therapeutic exercise protocol followed by a cryotherapy session of 20 min; (2) the sham control group that will receive the same regimen as the first group, but with sham packs filled with dry sand and (3) the active treatment control group that will receive only the therapeutic exercise protocol', 'Cryotherapy associated with tailored land-based exercises', 'cryotherapy']","['Western Ontario & McMaster Universities Osteoarthritis Index; the Short-Form Health Survey 36; the 30-s Chair Stand Test; the Stair Climb test; and the 40-m fast-paced walk test', 'pain intensity according to a Visual Analogue Scale']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0399066', 'cui_str': 'Insertion of malleable restoration into tooth'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C4759711', 'cui_str': 'Sand'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0887882,There is an unmet need to develop tailored therapeutic exercise protocols applying different treatment parameters and modalities for individuals with knee osteoarthritis (KOA).,"[{'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Ogura Dantas', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Ana Elisa', 'Initials': 'AE', 'LastName': 'Serafim Jorge', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Regina Mendes da Silva Serrão', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Aburquerque-Sendín', 'Affiliation': 'Sociosanitary Sciences, Radiology and Physical Medicine, Universidad de Córdoba, Cordoba, Andalucía, Spain.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'de Fatima Salvini', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil tania@ufscar.br.'}]",BMJ open,['10.1136/bmjopen-2019-035610']
1360,32482669,Photobiomodulation therapy associated with supervised therapeutic exercises for people with knee osteoarthritis: a randomised controlled trial protocol.,"BACKGROUND


Physical exercise, a cornerstone of the conservative management of knee osteoarthritis (KOA), is exhaustively recommended by important clinical guidelines. A strength therapeutic exercise program (STEP) relieves pain, improves physical function and ultimately ameliorates quality of life (QoL). Furthermore, photobiomodulation (PBM) has been used as an adjunct treatment for people with KOA; however, there are still controversial recommendations regarding its use on this population. Thus, we hypothesised that PBM, when associated with a STEP protocol on patients with KOA, could induce better clinical outcomes than a STEP protocol alone.
METHODS AND ANALYSIS


The study is a 6-month triple-blind placebo-controlled randomised clinical trial with intention-to-treat analysis. The trial will include 120 people with clinic and radiographic signs of KOA. The intervention consists of a supervised STEP and PBM protocols conducted over an 8-week intervention period. Assessments are performed at baseline, right after treatment, and 3-month and 6-month follow-up periods. The primary clinical outcome is pain intensity according to a 10 cm Visual Analogue Scale. Secondary outcomes are the global Western Ontario & McMaster Universities Osteoarthritis Index; QoL assessed by the 36-item Short-Form health survey questionnaire; and performance-based physical parameters assessed by the 30 s chair stand test; the stair climb test; and the 40 m fast-paced walk test.
ETHICS AND DISSEMINATION


The trial was approved by the Human Research Ethics Committee of the Federal University of São Carlos, São Paulo, Brazil (REC no 2.016.122). Results will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


Brazilian Clinical Trials Registry (U1111-1215-6510).",2020,"A strength therapeutic exercise program (STEP) relieves pain, improves physical function and ultimately ameliorates quality of life (QoL).","['people with KOA', 'knee osteoarthritis (KOA', 'people with knee osteoarthritis', '120 people with clinic and radiographic signs of KOA']","['Photobiomodulation therapy', 'strength therapeutic exercise program (STEP', 'photobiomodulation (PBM', 'supervised therapeutic exercises', 'placebo']","['global Western Ontario & McMaster Universities Osteoarthritis Index; QoL assessed by the 36-item Short-Form health survey questionnaire; and performance-based physical parameters assessed by the 30 s chair stand test; the stair climb test; and the 40\u2009m fast-paced walk test', 'pain, improves physical function and ultimately ameliorates quality of life (QoL', 'pain intensity according to a 10\u2009cm Visual Analogue Scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0220912', 'cui_str': 'signs'}]","[{'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",120.0,0.105911,"A strength therapeutic exercise program (STEP) relieves pain, improves physical function and ultimately ameliorates quality of life (QoL).","[{'ForeName': 'Ana E', 'Initials': 'AE', 'LastName': 'S Jorge', 'Affiliation': 'Department of Physiotherapy, Federal University of Sao Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'O Dantas', 'Affiliation': 'Department of Physiotherapy, Federal University of Sao Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'M S Serrão', 'Affiliation': 'Department of Physiotherapy, Federal University of Sao Carlos, São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Alburquerque-Sendín', 'Affiliation': 'Department of Sociosanitary Sciences, Radiology and Physical Medicine, Universidad de Córdoba, Instituto Maiomónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Andalucía, Spain.'}, {'ForeName': 'Tania F', 'Initials': 'TF', 'LastName': 'Salvini', 'Affiliation': 'Department of Physiotherapy, Federal University of Sao Carlos, São Carlos, São Paulo, Brazil tania@ufscar.br.'}]",BMJ open,['10.1136/bmjopen-2019-035711']
1361,32593123,Quality of life changes in response to yoga therapy in patients with schizophrenia: Reanalysis of Three randomized controlled trials.,,2020,,['patients with schizophrenia'],['yoga therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}]",[],,0.0595902,,"[{'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Ikai-Tani', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, M5S 2W6, Toronto, ON, Canada. Electronic address: sako0609@gmail.com.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Tani', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Kimel Family Translational Imaging-Genetics Laboratory, Centre for Addiction and Mental Health, 1001 Queen St W, M6J 1H4, Toronto, ON, Canada.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kamiyama', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uchida', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Geriatric Mental Health Program, Centre for Addiction and Mental Health, 1001 Queen St W, M6J 1H4, Toronto, ON, Canada.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102250']
1362,32596938,Re: Incidence and characteristics of pregnancy-related death across ten low- and middle-income geographical regions: secondary analysis of a cluster randomised controlled trial: The underestimated scourge of eclampsia in low-income countries.,,2020,,[],[],[],[],[],[],,0.361711,,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Scioscia', 'Affiliation': 'Department of Obstetrics and Gynaecology, Policlinico Hospital, Abano Terme, Padua, Italy.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Somigliana', 'Affiliation': ""Università degli Studi di Milano and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Sartie', 'Initials': 'S', 'LastName': 'Kenneh', 'Affiliation': 'Ministry of Health and Sanitation, Government of Sierra Leone, Freetown, Sierra Leone.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Robillard', 'Affiliation': ""Service de Néonatologie-Centre d'Etudes Périnatales Océan Indien (CEPOI), Centre Hospitalier Universitaire Sud Réunion, Saint-Pierre Cedex, La Réunion, France.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Dalle Carbonare', 'Affiliation': 'Department of Obstetrics and Gynaecology, Policlinico Hospital, Abano Terme, Padua, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Putoto', 'Affiliation': 'Operational Research Unit, Doctors with Africa CUAMM, Padua, Italy.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16351']
1363,32595160,Protocol for creating new warnings on cigarette packs and evaluating their efficacy in a randomised experimental setting.,"INTRODUCTION


Tobacco smoking is one of the leading causes of preventable death. This is not inevitable as tobacco control tools have become more powerful and more effective. Among these, warnings on cigarette packs have proven to be somewhat effective. Our objective is to increase the efficacy of antismoking warnings by using innovative psychological approaches and to create an experimental setting for the evaluation of these new warnings based on behavioural indicators.
METHODS AND ANALYSIS


First, we created new warnings based on three categories of motivational leverage and on harm reduction. New warnings with innovative texts and pictures were designed for each category and inserted on plain packs. We will then use standard indicators to compare their effect to that of control packs: plain pack without warning, plain pack with conventional warning and branded pack with conventional warning. Second, the novelty of our approach will consist in designing an experimental protocol that uses monetary incentives to evaluate the effect of warnings. Subjects will be able to 'sacrifice' part of their participation defrayal to purchase a good whose subjective value is related to one's attitude towards smoking. These monetarily incentivised measures are designed to assess smokers' immediate/mid-term intention to quit and non-smokers' aversion to smoking. In both cases, the monetary amounts individuals accept to sacrifice may be a more reliable measure than declarative responses, which may be distorted by several hypothetical biases. In the end, we should be able to robustly measure the impact of our new warnings between intervention and control groups by using both traditional indicators and our new monetarily incentivised measure.
ETHICS AND DISSEMINATION


The ethics committee of the  Groupement des Hôpitaux de l'Institut Catholique de Lille  approved the research protocol on 5 July 2019 (CIER 2019-22). Results will be presented at scientific meetings and published.",2020,"In the end, we should be able to robustly measure the impact of our new warnings between intervention and control groups by using both traditional indicators and our new monetarily incentivised measure.
",[],"['control packs: plain pack without warning, plain pack with conventional warning and branded pack with conventional warning']",[],[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]",[],,0.014774,"In the end, we should be able to robustly measure the impact of our new warnings between intervention and control groups by using both traditional indicators and our new monetarily incentivised measure.
","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ben Lakhdar', 'Affiliation': 'LEM UMR 9221 CNRS, University of Lille, Lille, Hauts-de-France, France christian.ben-lakhdar@univ-lille.fr.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Deplancke', 'Affiliation': 'ETHICS EA 7446, Lille Catholic University, Lille, Hauts-de-France, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Le Lec', 'Affiliation': 'ETHICS EA 7446, Lille Catholic University, Lille, Hauts-de-France, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Massin', 'Affiliation': 'LEM UMR 9221 CNRS, Artois University, Arras, Hauts-de-France, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Piermatteo', 'Affiliation': 'ETHICS EA 7446, Lille Catholic University, Lille, Hauts-de-France, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Vaillant', 'Affiliation': 'LEM UMR 9221 CNRS, University of Lille, Lille, Hauts-de-France, France.'}]",BMJ open,['10.1136/bmjopen-2019-036166']
1364,32595159,Economic evaluation alongside the Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (E-PROSPECT): study protocol.,"INTRODUCTION


Ventilator-associated pneumonia (VAP) is a common healthcare-associated infection in the intensive care unit (ICU). Probiotics are defined as live microorganisms that may confer health benefits when ingested. Prior randomised trials suggest that probiotics may prevent infections such as VAP and  Clostridioides difficile -associated diarrhoea (CDAD). PROSPECT (Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial) is a multicentre, double-blinded, randomised controlled trial comparing the efficacy of the probiotic  Lactobacillus rhamnosus  GG with usual care versus usual care without probiotics in preventing VAP and other clinically important outcomes in critically ill patients admitted to the ICU.
METHODS AND ANALYSIS


The objective of E-PROSPECT is to determine the incremental cost-effectiveness of  L. rhamnosus  GG plus usual care versus usual care without probiotics in critically ill patients. E-PROSPECT will be performed from the public healthcare payer's perspective over a time horizon from ICU admission to hospital discharge.We will determine probabilities of in-ICU and in-hospital events from all patients alongside PROSPECT. We will retrieve unit costs for each resource use item using jurisdiction-specific public databases, supplemented by individual site unit costs if such databases are unavailable. Direct costs will include medications, personnel costs, radiology/laboratory testing, operative/non-operative procedures and per-day hospital 'hoteling' costs not otherwise encompassed. The primary outcome is the incremental cost per VAP prevented between the two treatment groups. Other clinical events such as CDAD, antibiotic-associated diarrhoea and in-hospital mortality will be included as secondary outcomes. We will perform pre-specified subgroup analyses (medical/surgical/trauma; age; frailty status; antibiotic use; prevalent vs no prevalent pneumonia) and probabilistic sensitivity analyses for VAP, then generate confidence intervals using the non-parametric bootstrapping approach.
ETHICS AND DISSEMINATION


Study approval for E-PROSPECT was granted by the Hamilton Integrated Research Ethics Board of McMaster University on 29 July 2019. Informed consent was obtained from the patient or substitute decision-maker in PROSPECT. The findings of this study will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT01782755; Pre-results.",2020,The objective of E-PROSPECT is to determine the incremental cost-effectiveness of  ,"['critically ill patients admitted to the ICU', 'critically ill patients']","['probiotic  Lactobacillus rhamnosus  GG with usual care versus usual care without probiotics', 'L. rhamnosus  GG plus usual care versus usual care without probiotics', 'PROSPECT (Probiotics']",['incremental cost per VAP'],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",,0.217057,The objective of E-PROSPECT is to determine the incremental cost-effectiveness of  ,"[{'ForeName': 'Vincent Issac', 'Initials': 'VI', 'LastName': 'Lau', 'Affiliation': 'Department of Critical Care, University of Alberta Faculty of Medicine and Dentistry, Edmonton, Alberta, Canada vinceissaclau@gmail.com.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cook', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fowler', 'Affiliation': 'Sunnybrook Health Sciences Institute, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Rochwerg', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Johnstone', 'Affiliation': 'Public Health Ontario, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lauzier', 'Affiliation': 'Population Health and Optimal Health Practices Research Unit (Trauma-Emergency-Critical Care Medicine), Centre de Recherche du CHU de Québec-Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Marshall', 'Affiliation': 'Department of Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Basmaji', 'Affiliation': 'Department of Medicine, Division of Critical Care, Western University, London, Ontario, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036047']
1365,32446979,"Xinyue Capsule in patients with stable coronary artery disease after percutaneous coronary intervention: a multicenter, randomized, placebo-controlled trial.","BACKGROUND


Xinyue capsule, a patented Chinese herbal medicine, has been used to manage coronary artery disease (CAD) for over a decade in China, but whether it can further reduce risk of cardiovascular events beyond conventional treatment is unknown.
METHODS


In this multicenter, randomized, placebo-controlled trial, we randomly assigned patients with stable CAD who underwent percutaneous coronary intervention (PCI) within the preceding 3-12 months to receive Xinyue capsule (100 mg panax quinquefolius saponins, three times a day) or placebo for 24 weeks in addition to conventional treatment. The primary endpoint was a composite that included cardiac death, nonfatal myocardial infarction and urgent revascularization with either PCI or coronary artery bypass grafting. The secondary composite endpoints included stroke, re-hospitalization due to acute coronary syndrome (ACS), pulmonary embolism, peripheral vascular events and all-cause mortality. Quality of life was assessed using a 36-item Short-Form Health Survey (SF-36).
RESULTS


A total of 1054 participants were included in the analyses. The median follow up was 1 year. The primary endpoint events occurred in 16 patients (3.02%) in the Xinyue group and 34 patients (6.49%) in the placebo group (hazard ratio [HR] 0.455, 95% confidence interval [CI] 0.25 to 0.825; P = 0.009). Secondary end-point events occurred in 5.47% of patients in the Xinyue group and 10.31% in the placebo group (HR 0.515, 95% CI 0.328 to 0.809; P = 0.004). SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008).
CONCLUSIONS


In patients with stable CAD after PCI within the preceding 3 to 12 months, Xinyue capsule added on conventional treatment reduced the incidence of primary composite endpoint (cardiac death, nonfatal myocardial infarction and urgent revascularization).",2020,"SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008).
","['patients with stable CAD who underwent', 'A total of 1054 participants were included in the analyses', 'patients with stable coronary artery disease after percutaneous coronary intervention']","['percutaneous coronary intervention (PCI', 'Xinyue capsule (100\u2009mg panax quinquefolius saponins, three times a day) or placebo', 'Xinyue Capsule', 'placebo']","['SF-36 subscale scores', 'Secondary end-point events', 'Quality of life', 'composite that included cardiac death, nonfatal myocardial infarction and urgent revascularization with either PCI or coronary artery bypass grafting', 'stroke, re-hospitalization due to acute coronary syndrome (ACS), pulmonary embolism, peripheral vascular events and all-cause mortality', 'incidence of primary composite endpoint (cardiac death, nonfatal myocardial infarction and urgent revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3651791', 'cui_str': 'Panax quinquefolius whole extract'}, {'cui': 'C0036189', 'cui_str': 'Saponins'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",1054.0,0.559087,"SF-36 subscale scores at 12 months were significantly higher in the Xinyue group than placebo group for general health (P = 0.048) and vitality (P = 0.008).
","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Peili', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Jianpeng', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Changgeng', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Qiaoning', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Zhuye', 'Initials': 'Z', 'LastName': 'Gao', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}, {'ForeName': 'Mingjun', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': 'The First Affiliated Hospital of the Henan University of Chinese Medicine, Henan 450046, China.'}, {'ForeName': 'Shuzheng', 'Initials': 'S', 'LastName': 'Lv', 'Affiliation': 'Beijing Anzhen Hospital, Beijing Institute of Respiratory Medicine, Capital Medical University, Beijing 10029, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'The First Affiliated Hospital of Jilin University of Traditional Chinese Medicine, Changchun 130021, China.'}, {'ForeName': 'Tianchang', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Naval General Hospital, Beijing 100048, China.'}, {'ForeName': 'Dazhuo', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China. Electronic address: shidazhuo@cacms.cn.'}, {'ForeName': 'For The Xy', 'Initials': 'FTX', 'LastName': 'Working Group', 'Affiliation': 'Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091,China.'}]",Pharmacological research,['10.1016/j.phrs.2020.104883']
1366,32447296,"CALLA: Efficacy and safety of concurrent and adjuvant durvalumab with chemoradiotherapy versus chemoradiotherapy alone in women with locally advanced cervical cancer: a phase III, randomized, double-blind, multicenter study.","BackgroundConcurrent chemoradiotherapy is the standard of care for locally advanced cervical cancer. Concurrent chemoradiotherapy with programmed blockade of the cell death-1/programmed cell death-ligand 1 pathway may promote a more immunogenic environment through increased phagocytosis, cell death, and antigen presentation, leading to enhanced immune-mediated tumor surveillance.
PRIMARY OBJECTIVE


The CALLA trial is designed to determine the efficacy and safety of the programmed cell death-ligand 1 blocking antibody, durvalumab, with and following concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in women with locally advanced cervical cancer.
STUDY HYPOTHESIS


Durvalumab concurrent with and following concurrent chemoradiotherapy will improve progression-free survival in patients with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IB2 to IVA cervical cancer compared with concurrent chemoradiotherapy alone.
TRIAL DESIGN


CALLA is a phase III, randomized, multicenter, international, double-blind, placebo-controlled study. Patients will be randomized 1:1 to receive either durvalumab (1500 mg intravenously (IV)) or placebo every 4 weeks for 24 cycles. All patients will receive external beam radiotherapy with cisplatin (40 mg/m 2 ) IV or carboplatin (area under the curve 2) IV once a week for 5 weeks, followed by image-guided brachytherapy.
MAJOR INCLUSION/EXCLUSION CRITERIA


The study will enroll immunotherapy-naïve adult patients with histologically confirmed cervical adenocarcinoma, cervical squamous, or adenosquamous carcinoma FIGO 2009 stages IB2-IIB node positive and stage IIIA-IVA with any node stage. Patients will have had no prior definitive surgical, radiation, or systemic therapy for cervical cancer.
PRIMARY ENDPOINT


The primary endpoint is progression-free survival (assessed by the investigator according to Response Evaluation Criteria in Solid Tumors v1.1, histopathological confirmation of local tumor progression or death).
SAMPLE SIZE


Approximately 714 patients will be randomized 1:1 to receive either durvalumab + concurrent chemoradiotherapy or placebo + concurrent chemoradiotherapy.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


Patient enrollment is continuing globally with an estimated completion date of April 2024.
TRIAL REGISTRATION


NCT03830866.",2020,"Concurrent chemoradiotherapy with programmed blockade of the cell death-1/programmed cell death-ligand 1 pathway may promote a more immunogenic environment through increased phagocytosis, cell death, and antigen presentation, leading to enhanced immune-mediated tumor surveillance.
","['Patients will have had no prior definitive surgical, radiation, or systemic therapy for cervical cancer', 'naïve adult patients with histologically confirmed cervical adenocarcinoma, cervical squamous, or adenosquamous carcinoma FIGO 2009 stages IB2-IIB node positive and stage IIIA-IVA with any node stage', 'locally advanced cervical cancer', 'Approximately 714 patients', 'women with locally advanced cervical cancer', 'patients with International Federation of Gynecology and Obstetrics']","['durvalumab + concurrent chemoradiotherapy or placebo + concurrent chemoradiotherapy', 'chemoradiotherapy versus concurrent chemoradiotherapy alone', 'placebo', 'chemoradiotherapy', 'Concurrent chemoradiotherapy', 'durvalumab', 'immunotherapy', 'external beam radiotherapy with cisplatin (40\u2009mg/m 2 ) IV or carboplatin', 'CALLA', 'concurrent and adjuvant durvalumab with chemoradiotherapy versus chemoradiotherapy alone']","['progression-free survival', 'histopathological confirmation of local tumor progression or death', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0279672', 'cui_str': 'Adenocarcinoma of cervix'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0206623', 'cui_str': 'Adenosquamous carcinoma'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C0456532', 'cui_str': 'N category'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0331463', 'cui_str': 'Calla'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0178874', 'cui_str': 'Tumor progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.614757,"Concurrent chemoradiotherapy with programmed blockade of the cell death-1/programmed cell death-ligand 1 pathway may promote a more immunogenic environment through increased phagocytosis, cell death, and antigen presentation, leading to enhanced immune-mediated tumor surveillance.
","[{'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Mayadev', 'Affiliation': 'GYN Cancers, Rebecca and John Moores Cancer Center, La Jolla, California, USA.'}, {'ForeName': 'Ana T', 'Initials': 'AT', 'LastName': 'Nunes', 'Affiliation': 'AstraZeneca R&D Gaithersburg, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'AstraZeneca R&D Gaithersburg, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Marcovitz', 'Affiliation': 'AstraZeneca R&D Gaithersburg, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Lanasa', 'Affiliation': 'AstraZeneca R&D Gaithersburg, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Creighton University School of Medicine at St. Josephs Hospital and Medical Center, Phoenix, Arizona, USA bradley.monk@usoncology.com.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-001135']
1367,32452969,"Performance of Male Condoms When Used With and Without a Silicone Placebo Vaginal Ring-A Randomized, Crossover Trial.","BACKGROUND


The dapivirine vaginal ring reduced the risk of HIV infection by approximately 30% in Phase III trials. To ensure higher levels of protection against HIV and sexually transmitted infections, women should be counseled to use condoms when using the vaginal ring. This article evaluates the compatibility of male condoms with a placebo vaginal ring.
METHODS


This was a 2-period crossover, randomized, noninferiority trial. Couples in 2 sites in the United States were randomized to male condom use, with and without a placebo silicone vaginal ring, and asked to use 4 male condoms in each period. The primary noninferiority end points were total clinical failure and their component failure events (clinical breakage or slippage). Frequencies and percentages were calculated for each failure mode and differences in performance of the 2 periods using the male condom without the ring as reference. Noninferiority was defined using a 3% margin at the 5% significance level. Safety and acceptability were also assessed.
RESULTS


Seventy couples were enrolled, and 68 completed the trial with a total of 275 male condoms used in each period. Total condom clinical failure rates were 2.2% and 4.0% in the presence and absence of the vaginal ring, respectively, with a difference of -1.9% (95% confidence interval: -5.3% to 1.5%), thereby demonstrating noninferiority when used with the ring. There was no difference in safety between the 2 periods.
DISCUSSION


Concurrent use of the placebo silicone vaginal ring had no significant effect on male condom functionality or safety outcomes.",2020,"There was no difference in safety between the two periods.
","['Couples in two sites in the United States of America', 'Seventy couples were enrolled, and 68 completed the trial with a total of 275 male condoms used in each period', 'male condoms with a placebo vaginal ring']","['Silicone Placebo', 'placebo silicone vaginal ring']","['risk of HIV infection', 'Total condom clinical failure rates', 'safety', 'total clinical failure and their component failure events (clinical breakage or slippage', 'male condom functionality or safety outcomes', 'Safety and acceptability']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}]","[{'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",275.0,0.452772,"There was no difference in safety between the two periods.
","[{'ForeName': 'Annalene', 'Initials': 'A', 'LastName': 'Nel', 'Affiliation': 'International Partnership for Microbicides, Silver Spring, MD.'}, {'ForeName': 'Mariëtte', 'Initials': 'M', 'LastName': 'Malherbe', 'Affiliation': 'International Partnership for Microbicides, Silver Spring, MD.'}, {'ForeName': 'Neliëtte', 'Initials': 'N', 'LastName': 'van Niekerk', 'Affiliation': 'International Partnership for Microbicides, Silver Spring, MD.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Greener', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Smit', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Frezieres', 'Affiliation': 'Essential Access Health, Los Angeles, CA.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': 'Essential Access Health, Los Angeles, CA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002397']
1368,32452973,"Performance and Acceptability of the FC2 Female Condom When Used With and Without a Silicone Placebo Vaginal Ring-A Randomized, Crossover Trial.","BACKGROUND


The silicone Dapivirine Vaginal Ring 25 mg, has been developed to provide an additional HIV prevention option for women. If approved for use, women will always be counselled to use condoms when using the vaginal ring for maximum protection. This paper evaluates the compatibility of female condoms with the ring.
METHODS


This was a 2-period crossover, randomized noninferiority trial. Couples in 2 sites in the United States of America were randomized to FC2 Female Condom (FC2) with and without a placebo silicone ring and asked to use 4 female condoms in each period. The primary noninferiority endpoint was the clinical failure rate during intercourse or withdrawal (self-reported clinical breakage, slippage, misdirection, and invagination). Frequencies and percentages were calculated for each failure mode and differences in performance of the 2 periods, using the female condom without the ring as reference. Noninferiority was defined using an 8% margin at the 5% significance level. Safety and tolerability were also assessed.
RESULTS


Eighty-one couples were enrolled and 79 completed the trial using a total of 596 female condoms (297 and 299 with/without a ring inserted, respectively). Total female condom clinical failure was 14.1% and 15.7% in the presence and absence of a ring, respectively, with a difference of -2.1% (95% confidence interval: -7.8% to 3.6%), thereby demonstrating noninferiority when used with the ring. There were no differences in safety and tolerability between the 2 periods.
DISCUSSION


Concurrent use of the placebo silicone vaginal ring had no significant effect on female condom functionality or safety outcomes.",2020,"There were no differences in safety and tolerability between the two periods.
","['female condoms with the ring', 'Eighty-one couples were enrolled and 79 completed the trial using a total of 596 female condoms (297 and 299 with/without a ring inserted, respectively', 'Couples in two sites in the United States of America', 'women']","['FC2 Female Condom®', 'FC2 Female Condom (FC2) with and without a placebo silicone', 'placebo silicone vaginal ring']","['Total female condom clinical failure', 'Safety and tolerability', 'safety and tolerability', 'female condom functionality or safety outcomes', 'clinical failure rate during intercourse or withdrawal (self-reported clinical breakage, slippage, misdirection and invagination', 'Performance and Acceptability']","[{'cui': 'C0221829', 'cui_str': 'Female condom'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0221829', 'cui_str': 'Female condom'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0221829', 'cui_str': 'Female condom'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0221224', 'cui_str': 'Invagination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",81.0,0.391157,"There were no differences in safety and tolerability between the two periods.
","[{'ForeName': 'Annalene', 'Initials': 'A', 'LastName': 'Nel', 'Affiliation': 'International Partnership for Microbicides, Silver Spring, MD.'}, {'ForeName': 'Mariëtte', 'Initials': 'M', 'LastName': 'Malherbe', 'Affiliation': 'International Partnership for Microbicides, Silver Spring, MD.'}, {'ForeName': 'Neliëtte', 'Initials': 'N', 'LastName': 'van Niekerk', 'Affiliation': 'International Partnership for Microbicides, Silver Spring, MD.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Greener', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Smit', 'Affiliation': 'MRU [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Frezieres', 'Affiliation': 'Essential Access Health, Los Angeles, CA.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Walsh', 'Affiliation': 'Essential Access Health, Los Angeles, CA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002408']
1369,32453116,Goal Attainment Scaling Rehabilitation Improves Satisfaction with Work Activities for Younger Working Patients After Knee Arthroplasty: Results from the Randomized Controlled ACTION Trial.,"BACKGROUND


Knee arthroplasty (KA) is increasingly performed in relatively young, active patients. This heterogeneous patient population often has high expectations, including work resumption and performance of knee-demanding leisure-time activities. Goal attainment scaling (GAS) may personalize rehabilitation by using patient-specific, activity-oriented rehabilitation goals. Since unmet expectations are a leading cause of dissatisfaction after KA, personalized rehabilitation may improve patient satisfaction. We hypothesized that, compared with standard rehabilitation, GAS-based rehabilitation would result in younger, active patients having higher satisfaction regarding activities after KA.
METHODS


We performed a single-center randomized controlled trial. Eligible patients were <65 years of age, working outside the home, and scheduled to undergo unicompartmental or total KA. The required sample size was 120 patients. Using GAS, patients developed personal activity goals with a physiotherapist preoperatively. These goals were used to monitor patients' goal attainment and provide goal-specific feedback during postoperative outpatient rehabilitation. Standard rehabilitation consisted of regular outpatient physiotherapy visits. The primary outcome measures were visual analogue scale (VAS) scores (scale of 0 to 100) for satisfaction regarding activities of daily living and work and leisure-time activities 1 year postoperatively, which were analyzed using generalized estimating equation models.
RESULTS


Patient satisfaction with work activities was significantly higher in the GAS group (β = 10.7 points, 98% confidence interval [CI] = 2.0 to 19.4 points) than in the control group. Patient satisfaction with activities of daily living and leisure-time activities did not differ between groups. We found no differences in VAS satisfaction scores between unicompartmental KA and total KA.
CONCLUSIONS


Personalized, goal-specific rehabilitation using GAS resulted in higher patient satisfaction with work activities, compared with standard rehabilitation, 1 year after KA.
LEVEL OF EVIDENCE


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"RESULTS


Patient satisfaction with work activities was significantly higher in the GAS group (β = 10.7 points, 98% confidence interval [CI] = 2.0 to 19.4 points) than in the control group.","['Younger Working Patients', 'After Knee Arthroplasty', 'relatively young, active patients', 'Eligible patients were <65 years of age, working outside the home, and scheduled to undergo unicompartmental or total KA']","['Knee arthroplasty (KA', 'Goal Attainment Scaling Rehabilitation', 'regular outpatient physiotherapy visits', 'standard rehabilitation, GAS-based rehabilitation']","['Patient satisfaction with activities of daily living and leisure-time activities', 'VAS satisfaction scores', 'visual analogue scale (VAS) scores (scale of 0 to 100) for satisfaction regarding activities of daily living and work and leisure-time activities 1 year postoperatively', 'Patient satisfaction with work activities', 'personal activity goals']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",120.0,0.240302,"RESULTS


Patient satisfaction with work activities was significantly higher in the GAS group (β = 10.7 points, 98% confidence interval [CI] = 2.0 to 19.4 points) than in the control group.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hoorntje', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation for Orthopaedic Research Care and Education, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Waterval-Witjes', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation for Orthopaedic Research Care and Education, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Koen L M', 'Initials': 'KLM', 'LastName': 'Koenraadt', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation for Orthopaedic Research Care and Education, Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'P Paul F M', 'Initials': 'PPFM', 'LastName': 'Kuijer', 'Affiliation': 'Coronel Institute of Occupational Health, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Leendert', 'Initials': 'L', 'LastName': 'Blankevoort', 'Affiliation': 'Department of Orthopaedic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Gino M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Department of Orthopaedic Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam Movement Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Rutger C I', 'Initials': 'RCI', 'LastName': 'van Geenen', 'Affiliation': 'Department of Orthopaedic Surgery, Foundation for Orthopaedic Research Care and Education, Amphia Hospital, Breda, the Netherlands.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01471']
1370,32580207,Metabolic activity in subcallosal cingulate predicts response to deep brain stimulation for depression.,"Subcallosal cingulate (SCC) deep brain stimulation (DBS) is a promising therapy for treatment-resistant depression (TRD), but response rates in open-label studies were not replicated in a large multicenter trial. Identifying biomarkers of response could improve patient selection and outcomes. We examined SCC metabolic activity as both a predictor and marker of SCC DBS treatment response. Brain glucose metabolism (CMRGlu) was measured with [18F] FDG-PET at baseline and 6 months post DBS in 20 TRD patients in a double-blind randomized controlled trial where two stimulation types (long pulse width (LPW) n = 9 and short pulse width (SPW) n = 11) were used. Responders (n = 10) were defined by a ≥48% reduction in Hamilton Depression Rating Scale scores after 6 months. The response rates were similar with five responders in each stimulation group: LPW (55.6%) and SPW (44.5%). First, differences in SCC CMRGlu in responders and non-responders were compared at baseline. Then machine learning analysis was performed with a leave-one-out cross-validation using a Gaussian naive Bayes classifier to test whether baseline CMRGlu in SCC could categorize responders. Finally, we compared 6-month change in metabolic activity with change in depression severity. All analyses were controlled for age. Baseline SCC CMRGlu was significantly higher in responders than non-responders. The machine learning analysis predicted response with 80% accuracy. Furthermore, reduction in SCC CMRGlu 6 months post DBS correlated with symptom improvement (r(17) = 0.509; p = 0.031). This is the first evidence of an image-based treatment selection biomarker that predicts SCC DBS response. Future studies could utilize SCC metabolic activity for prospective patient selection.",2020,The response rates were similar with five responders in each stimulation group: LPW (55.6%) and SPW (44.5%).,['20 TRD patients'],['Subcallosal cingulate (SCC) deep brain stimulation (DBS'],"['Brain glucose metabolism (CMRGlu', 'Baseline SCC CMRGlu', 'SCC metabolic activity', 'response rates', 'metabolic activity', 'Hamilton Depression Rating Scale scores']","[{'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0983597,The response rates were similar with five responders in each stimulation group: LPW (55.6%) and SPW (44.5%).,"[{'ForeName': 'Elliot C', 'Initials': 'EC', 'LastName': 'Brown', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Darren L', 'Initials': 'DL', 'LastName': 'Clark', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Nils D', 'Initials': 'ND', 'LastName': 'Forkert', 'Affiliation': 'Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Molnar', 'Affiliation': 'Department of Radiology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Zelma H T', 'Initials': 'ZHT', 'LastName': 'Kiss', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Rajamannar', 'Initials': 'R', 'LastName': 'Ramasubbu', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada. rramasub@ucalgary.ca.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0745-5']
1371,32459653,Tailored Medication Adherence Incentives Using mHealth for Children With High-Risk Asthma (TAICAM): Protocol for a Randomized Controlled Trial.,"BACKGROUND


Poor adherence to inhaled corticosteroid medications for children with high-risk asthma is both well documented and poorly understood. It has a disproportionate prevalence and impact on children of minority demographics in urban settings. Financial incentives have been shown to be a compelling method to engage those in a high-risk asthma population, but whether adherence can be maintained by offering financial incentives and how these incentives can be used to sustain high adherence are unknown.
OBJECTIVE


The aim of this study is to determine the marginal effects of a financial incentive-based intervention on inhaled corticosteroid adherence, health care system use, and costs.
METHODS


Participants include children aged 5 to 12 years who have had either at least two hospitalizations or one hospitalization and one emergency department visit for asthma in the year prior to their enrollment (and their caregivers). Participants are given an electronic inhaler sensor in order to track their medication use over a period of 7 months. After a 1-month period of observation, participants are randomized to 1 of 3 arms for a 3-month period. Participants in arm 1 receive daily text message reminders, feedback, and gain-framed, nominal financial incentives; participants in arm 2 receive daily text message reminders and feedback only, and participants in arm 3 receive no reminders, feedback, or incentives. All participants are subsequently observed for an additional 3-month period with no reminders, feedback, or incentives to assess whether any sustained effects are apparent.
RESULTS


Study enrollment began in September 2019 with a target sample size of N=125 children. As of June 2020, 61 children have been enrolled. Data collection is estimated to be completed in June 2022, and analyses will be completed by June 2023.
CONCLUSIONS


This study will provide data that will help to determine whether a financial incentive-based mobile health intervention for promoting inhaled corticosteroid use can be effective in patients with high-risk asthma over longer periods.
TRIAL REGISTRATION


Clinicaltrial.gov NCT03907410; https://clinicaltrials.gov/ct2/show/NCT03907410.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/16711.",2020,"All participants are then observed for an additional 3 months with no reminders, feedback, or incentives to assess for sustained effects.
","['urban minority children', 'Participants include 125 children aged 5-12 years who have had at least two hospitalizations or one hospitalization and one emergency room visit for asthma in the prior year and their caregivers', 'Children with High-Risk Asthma', 'child-caregiver dyads', 'children with high-risk asthma']","['financial incentive-based ICS adherence intervention', 'financial incentive-based mobile-health intervention', 'daily text message reminders, feedback, and nominal gain-framed financial incentives; those in arm 2 receive daily text message reminders and feedback only and those in arm 3 receive no reminders, feedback, or incentives', 'inhaled corticosteroid (ICS) medications']","['adherence, healthcare system use, and costs']","[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",125.0,0.168191,"All participants are then observed for an additional 3 months with no reminders, feedback, or incentives to assess for sustained effects.
","[{'ForeName': 'Brittney R', 'Initials': 'BR', 'LastName': 'Henderson', 'Affiliation': ""Roberts Center for Pediatric Research, Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Carina M', 'Initials': 'CM', 'LastName': 'Flaherty', 'Affiliation': ""Roberts Center for Pediatric Research, Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'G Chandler', 'Initials': 'GC', 'LastName': 'Floyd', 'Affiliation': ""Roberts Center for Pediatric Research, Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'You', 'Affiliation': ""Roberts Center for Pediatric Research, Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Xiao', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Tyra C', 'Initials': 'TC', 'LastName': 'Bryant-Stephens', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Victoria A', 'Initials': 'VA', 'LastName': 'Miller', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Feudtner', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}, {'ForeName': 'Chén Collin', 'Initials': 'CC', 'LastName': 'Kenyon', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, United States.""}]",JMIR research protocols,['10.2196/16711']
1372,32464224,Higher- or Usual-Volume Feedings in Infants Born Very Preterm: A Randomized Clinical Trial.,"OBJECTIVE


To determine whether higher-volume feedings improve postnatal growth among infants born very preterm.
STUDY DESIGN


Randomized clinical trial with 1:1 parallel allocation conducted from January 2015 to June 2018 in a single academic medical center in the US. In total, 224 infants with a birth weight 1001-2500 g born at <32 weeks of gestation were randomized to higher-volume (180-200 mL/kg/d) or usual-volume (140-160 mL/kg/d) feedings after establishing full enteral feedings (≥120 mL/kg/d). The primary outcome was growth velocity (g/kg/d) from randomization to study completion at 36 weeks of postmenstrual age or hospital discharge if earlier.
RESULTS


Growth velocity increased among infants in the higher-volume group compared with the usual-volume group (mean [SD], 20.5 [4.5] vs 17.9 [4.5] g/kg/d; P < .001). At study completion, all measurements were higher among infants in the higher-volume group compared with the usual-volume group: weight (2365 [324] g, z score -0.60 [0.73] vs 2200 [308] g, z score -0.94 [0.71]; P < .001); head circumference (31.9 [1.3] cm, z score -0.30 [0.91] vs 31.4 [1.3] cm, z score -0.53 [0.84]; P = .01); length (44.9 [2.1] cm, z score -0.68 [0.88] vs 44.4 [2.0], z score -0.83 [0.84]; P = .04); and mid-arm circumference (8.8 [0.8] cm vs 8.4 [0.8] cm; P = .002). Bronchopulmonary dysplasia, patent ductus arteriosus, necrotizing enterocolitis, or other adverse outcomes did not differ between groups.
CONCLUSIONS


In infants born very preterm weighing 1001-2500 g at birth, higher-volume feedings increased growth velocity, weight, head circumference, length, and mid-arm circumference compared with usual-volume feedings without adverse effects.
TRIAL REGISTRATION


ClinicalTrials.gov; NCT02377050.",2020,"Bronchopulmonary dysplasia, patent ductus arteriosus, necrotizing enterocolitis, or other adverse outcomes did not differ between groups.
","['Very Preterm Infants', '224 infants with a birth weight 1001-2500 grams born at <32 weeks of gestation', 'very preterm infants', '1/2015 to 6/2018 in a single academic medical center in the United States']",['usual volume feedings'],"['growth velocity, weight, head circumference, length, and mid-arm circumference', 'Bronchopulmonary dysplasia, patent ductus arteriosus, necrotizing enterocolitis', 'growth velocity', 'head circumference', 'hospital discharge if earlier', 'Growth velocity']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4319601', 'cui_str': '2500'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",224.0,0.372561,"Bronchopulmonary dysplasia, patent ductus arteriosus, necrotizing enterocolitis, or other adverse outcomes did not differ between groups.
","[{'ForeName': 'Colm P', 'Initials': 'CP', 'LastName': 'Travers', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL. Electronic address: ctravers@peds.uab.edu.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL; Department of Pediatrics, Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Ariel A', 'Initials': 'AA', 'LastName': 'Salas', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Schofield', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL; Department of Pediatrics, Division of Neonatology, University of Maryland, Baltimore, MD.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Dills', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL; Department of Surgery, Louisiana State University Health Sciences Center, New Orleans, LA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Laney', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Yee', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL; Department of Pediatrics, Division of Neonatology, Nemours Alfred I. duPont Hospital for Children, Wilmington, DE.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Bhatia', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Lindy', 'Initials': 'L', 'LastName': 'Winter', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Namasivayam', 'Initials': 'N', 'LastName': 'Ambalavanan', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Waldemar A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.05.033']
1373,32473556,Functional training with blood occlusion influences muscle quality indices in older adults.,"OBJECTIVES


This study aimed to determine if functional training with blood flow restriction (BFR) has a greater effect on muscle quality indices and performance of older men when compared to functional training without BFR.
MATERIALS AND METHODS


Thirty men (67.7 ± 5.8 years) were randomly assigned to one of the following three groups: functional training (FT), functional training with blood flow restriction (FTBFR), and control (C). Participants in both experimental groups trained three sessions per week for six weeks. The training program included eleven body exercises, which were performed in 2-4 sets of 10 repetitions. FTBFR group wore pneumatic cuffs on their extremities that begun with 50 % of estimated arterial occlusion pressure and increased by 10 % every 2 weeks. Before and after the intervention period, subjects completed a series of tests to assess physical performances along with changes serum muscle quality indices.
RESULTS


A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05). In addition, the levels of CAF in FTBFR group was significantly lower compared to control group. Moreover, the circulatory levels of N-terminal propeptide type III collagen (P3NP) were reduced significantly in FT and C groups (p ≤ 0.05) but did not statistically differ from baseline in FTBFR group (p > 0.05). These changes were accompanied by significant improvements in dynamic strength, flexibility, static, and dynamic balance in both training groups (p ≤ 0.01).
CONCLUSIONS


The finding showed greater improvements in muscle quality indices and functional performance of older men when exercises performed with BFR.",2020,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"['Thirty men (67.7\u202f±\u202f5.8 years', 'older adults', 'older men']","['Functional training with blood occlusion', 'FTBFR group wore pneumatic cuffs', 'functional training with blood flow restriction (BFR', 'functional training (FT), functional training with blood flow restriction (FTBFR), and control (C']","['circulatory levels of N-terminal propeptide type III collagen (P3NP', 'dynamic strength, flexibility, static, and dynamic balance', 'serum C-terminal Agrin Fragment (CAF) levels', 'arterial occlusion pressure', 'muscle quality indices and functional performance', 'levels of CAF']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009332', 'cui_str': 'Collagen type III'}, {'cui': 'C0072054', 'cui_str': 'procollagen Type III-N-terminal peptide'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4077009', 'cui_str': 'C-terminal agrin fragment'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0143913,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"[{'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Bigdeli', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Dehghaniyan', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran. Electronic address: amani_sadegh@khu.ac.ir.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rajabi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Gahreman', 'Affiliation': 'College of Health and Human Sciences, Charles Darwin University, Darwin, Northern Territory, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104110']
1374,32483147,"Analysis of immune, microbiota and metabolome maturation in infants in a clinical trial of Lactobacillus paracasei CBA L74-fermented formula.","Mother's milk is the best choice for infants nutrition, however when it is not available or insufficient to satisfy the needs of the infant, formula is proposed as an effective substitute. Here, we report the results of a randomized controlled clinical trial (NCT03637894) designed to evaluate the effects of two different dietary regimens (standard formula and Lactobacillus paracasei CBA L74-fermented formula) versus breastfeeding (reference group) on immune defense mechanisms (primary endpoint: secretory IgA, antimicrobial peptides), the microbiota and its metabolome (secondary outcomes), in healthy full term infants according to the type of delivery (n = 13/group). We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk. Metabolome analysis allowed us to distinguish subjects based on their dietary regimen and mode of delivery. Together, these results suggest that a fermented formula favors the maturation of the immune system, microbiota and metabolome.",2020,"We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk.",['healthy full term infants according to the type of delivery (n\u2009=\u200913/group'],"['Lactobacillus paracasei CBA', 'dietary regimens (standard formula and Lactobacillus paracasei CBA L74-fermented formula']","['secretory IgA', 'safe and well tolerated']","[{'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}, {'cui': 'C0025922', 'cui_str': 'Mouse, Inbred CBA'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}]","[{'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}]",,0.03072,"We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk.","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Roggero', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy. paola.roggero@unimi.it.""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Liotto', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Pozzi', 'Affiliation': 'Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Braga', 'Affiliation': 'Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Troisi', 'Affiliation': 'Theoreo Srl, Via degli Ulivi 3, 84090, Montecorvino Pugliano, SA, Italy.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Menis', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Maria Lorella', 'Initials': 'ML', 'LastName': 'Giannì', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Berni Canani', 'Affiliation': 'Department of Translational Medical Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Paparo', 'Affiliation': 'Department of Translational Medical Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nocerino', 'Affiliation': 'Department of Translational Medical Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Budelli', 'Affiliation': 'School of Engineering, Niccoló Cusano University, Rome, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rescigno', 'Affiliation': 'Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy. maria.rescigno@hunimed.eu.'}]",Nature communications,['10.1038/s41467-020-16582-1']
1375,32479544,Long-term effects of a three-component lifestyle intervention on emotional well-being in women with Polycystic Ovary Syndrome (PCOS): A secondary analysis of a randomized controlled trial.,"Many women with Polycystic Ovary Syndrome (PCOS) report high depression rates. The relationship between PCOS and these high depression rates is unclear. Two-component lifestyle interventions have revealed short-term effects on depression scores in this group of women. In general, 3-component interventions including diet, exercise, and cognitive behavioral therapy (CBT) are more effective in the long-term to improve emotional well-being. This has not yet been studied in women with PCOS. This study examined the effect of 20 CBT lifestyle (LS) sessions combined with a healthy diet and physical therapy with or without 9 months additional feedback through Short Message Service (SMS) via mobile phone, compared to care as usual (CAU, involving advice to lose weight). In this secondary analysis, 155 women with PCOS and a BMI above 25 kg/m2 were eligible. Depression scores decreased significantly in the LS programme compared to CAU (P = 0.045). In both the LS programme without SMS (P = 0.036) and the LS programme with SMS (P = 0.011) depression scores decreased while no change was observed in CAU (P = 0.875). Self-esteem scores improved significantly in the LS programme compared to CAU (P = 0.027). No differences in body image scores were observed in LS participants compared to CAU (P = 0.087), although body image improved significantly in both the LS without SMS (P = 0.001) and with SMS (P = 0.008) study arms. We found no significant mediating role by androgens in the relationship between LS participants and emotional well-being. Only weight-loss mediated the relationship between LS and self-esteem. To conclude, a three-component lifestyle intervention programme with or without additional SMS resulted in significant improvements in depression and self-esteem compared to CAU, in women with PCOS, obesity, and a wish to achieve a pregnancy. Testosterone, androstenedione, DHEA, insulin, HOMA-IR, and cortisol did not mediate this effect. Weight loss mediated the effects on self-esteem but not on depression and body-image. This suggests that lifestyle treatment independent of weight loss can reduce depression and body-image, but both lifestyle treatment and weight loss can improve self-esteem. Thus, a three-component lifestyle intervention based on CBT could prove successful in improving mood in women with PCOS who are overweight or obese and attempting to become pregnant.",2020,Self-esteem scores improved significantly in the LS programme compared to CAU (P = 0.027).,"['155 women with PCOS and a BMI above 25 kg/m2 were eligible', 'women with Polycystic Ovary Syndrome (PCOS', 'women with PCOS', 'women with PCOS who are overweight or obese and attempting to become pregnant']","['three-component lifestyle intervention', 'CBT', '3-component interventions including diet, exercise, and cognitive behavioral therapy (CBT', '20 CBT lifestyle (LS) sessions combined with a healthy diet and physical therapy with or without 9 months additional feedback through Short Message Service (SMS) via mobile phone, compared to care as usual (CAU, involving advice to lose weight']","['Depression scores', 'depression and self-esteem', 'Testosterone, androstenedione, DHEA, insulin, HOMA-IR, and cortisol', 'depression scores', 'body image scores', 'self-esteem', 'Self-esteem scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0005891', 'cui_str': 'Body image'}]",155.0,0.0638994,Self-esteem scores improved significantly in the LS programme compared to CAU (P = 0.027).,"[{'ForeName': 'Geranne', 'Initials': 'G', 'LastName': 'Jiskoot', 'Affiliation': 'Division Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Dietz de Loos', 'Affiliation': 'Division Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Annemerle', 'Initials': 'A', 'LastName': 'Beerthuizen', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Reinier', 'Initials': 'R', 'LastName': 'Timman', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Busschbach', 'Affiliation': 'Department of Psychiatry, Section Medical Psychology and Psychotherapy, Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Joop', 'Initials': 'J', 'LastName': 'Laven', 'Affiliation': 'Division Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Erasmus MC, Rotterdam, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0233876']
1376,32482355,[Effects of remifentanil on awakening of propofol sedated patients submitted to upper gastrointestinal endoscopy: a randomized clinical trial].,"BACKGROUND AND OBJECTIVES


Sedation for endoscopic procedures aims to provide high quality sedation, lower risks, short recovery time, superior recovery quality and absence of side effects, seeking high patient level of satisfaction. The goal of the study was to assess administration of remifentanil combined with propofol regarding the effects of the drug association during sedation and recovery for patients submitted to upper GI diagnostic endoscopy.
METHOD


One hundred and five patients were assessed, randomly divided into three groups of 35 patients. The Control Group was sedated with propofol alone. Study Group 1 was sedated with a fixed dose of 0.2 μg.kg -1  remifentanil combined with propofol. Study Group 2 was sedated with 0.3 μg.kg -1  remifentanil combined with propofol. We assessed the quality of sedation, hemodynamic parameters, incidence of significant hypoxemia, time for spontaneous eye opening, post-anesthetic recovery time, quality of post-anesthetic recovery, presence of side effects and patient satisfaction.
RESULTS


Study Group 1 showed better quality of sedation. The groups in which remifentanil was administered combined with propofol showed shorter eye-opening time and shorter post-anesthetic recovery time compared to the control group. The three groups presented hemodynamic changes at some of the moments assessed. The incidence of significant hypoxemia, the quality of post-anesthetic recovery, the incidence of side effects and patient satisfaction were similar in the three groups.
CONCLUSIONS


The combination of propofol with remifentanil at a dose of 0.2 μg.kg -1  was effective in improving the quality of sedation, and at doses of 0.2 μg.kg -1  and 0.3 μg.kg -1  reduced the time to spontaneous eye opening and post-anesthetic recovery in comparison to sedation with propofol administered alone.",2020,"The incidence of significant hypoxemia, the quality of post-anesthetic recovery, the incidence of side effects and patient satisfaction were similar in the three groups.
","['awakening of propofol sedated patients submitted to upper gastrointestinal endoscopy', 'One hundred and five patients', 'patients submitted to upper GI diagnostic endoscopy']","['propofol with remifentanil', 'remifentanil combined with propofol', 'remifentanil', 'propofol alone', 'propofol']","['hemodynamic changes', 'quality of sedation, hemodynamic parameters, incidence of significant hypoxemia, time for spontaneous eye opening, post-anesthetic recovery time, quality of post-anesthetic recovery, presence of side effects and patient satisfaction', 'shorter eye-opening time and shorter post-anesthetic recovery time', 'incidence of significant hypoxemia, the quality of post-anesthetic recovery, the incidence of side effects and patient satisfaction', 'quality of sedation']","[{'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079304', 'cui_str': 'Esophagogastroduodenoscopy'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0203057', 'cui_str': 'Upper gastrointestinal tract series'}, {'cui': 'C0497101', 'cui_str': 'Diagnostic endoscopy'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",105.0,0.0770421,"The incidence of significant hypoxemia, the quality of post-anesthetic recovery, the incidence of side effects and patient satisfaction were similar in the three groups.
","[{'ForeName': 'Gustavo Nadal', 'Initials': 'GN', 'LastName': 'Uliana', 'Affiliation': 'Universidade Federal do Paraná (UFPR), Programa de Pós-Graduação em Clínica Cirúrgica, Curitiba, PR, Brazil; Hospitais Vita, Serviço de Anestesiologia, Curitiba, PR, Brazil. Electronic address: gnuliana@hotmail.com.'}, {'ForeName': 'Elizabeth Milla', 'Initials': 'EM', 'LastName': 'Tambara', 'Affiliation': 'Universidade Federal do Paraná (UFPR), Curitiba, PR, Brazil; Pontifícia Universidade Católica do Paraná, Escola de Medicina, Disciplina de Anestesiologia, Curitiba, PR, Brazil.'}, {'ForeName': 'Renato Tambara', 'Initials': 'RT', 'LastName': 'Filho', 'Affiliation': 'Universidade Federal do Paraná (UFPR), Hospital de Clínicas, Curitiba, PR, Brazil.'}, {'ForeName': 'Giorgio Alfredo Pedroso', 'Initials': 'GAP', 'LastName': 'Baretta', 'Affiliation': 'Universidade Federal do Paraná (UFPR), Curitiba, PR, Brazil.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.03.004']
1377,32491236,The McGill Denture Satisfaction Questionnaire revisited: Exploratory factor analysis of a binational sample.,"OBJECTIVES


To examine the McGill Denture Satisfaction Questionnaire (MDSQ) in terms of dimensionality, item reduction and construct validity in a binational sample of complete denture wearers.
MATERIALS AND METHODS


We conducted secondary analyses of baseline data from two studies on implant-retained overdentures: a quasi-experimental study in the United States (n = 145) and a randomised trial in Brazil (n = 120). All participants wore upper/lower dentures and responded at baseline to the MDSQ items concerning their original mandibular dentures. A putative model of the MDSQ items resulted in two question subsets: (a) overall satisfaction, retention/stability, aesthetics, cleaning, speech and comfort, plus general chewing ability; (b) mastication of specific foods. Analyses focused on the internal consistency of each subset and possible item reduction, using Cronbach's alpha (Cα), inter-item correlation and exploratory factor analysis (EFA).
RESULTS


The 1st subset showed high inter-item correlation for most question combinations and no redundancy (r ≤ .8). An item on cleaning had low correlation, but its removal does not increase internal consistency (Cα ≥ .83). Results were similar for both studies, with EFA showing a single significant factor (namely ""overall satisfaction, lower denture"") able to explain nearly 54% of the variance. The 2nd subset also shows strong internal consistency (Cα ≥ .95) and inter-item correlation, with a single factor representing 65% of the variation.
CONCLUSIONS


This study discloses the reliability and construct validity of the MDSQ for patient-centred evaluation of complete dental prostheses in the edentulous mandible. Findings also support the use of both ""overall satisfaction"" and ""masticatory ability"" as summary scores, for improved outcome assessment.",2020,The 1st subset showed high inter-item correlation for most question combinations and no redundancy (r ≤ .8).,"['patient-centred evaluation of complete dental prostheses in the edentulous mandible', 'We conducted secondary analyses of baseline data from two studies on implant-retained overdentures: a quasi-experimental study in the United States (n\xa0=\xa0145) and a randomised trial in Brazil (n\xa0=\xa0120', 'binational sample of complete denture wearers']",['MDSQ'],"['overall satisfaction, retention/stability, aesthetics, cleaning, speech and comfort, plus general chewing ability; (b) mastication of specific foods', 'internal consistency ', ""Cronbach's alpha (Cα), inter-item correlation and exploratory factor analysis (EFA"", 'McGill Denture Satisfaction Questionnaire (MDSQ', 'single significant factor (namely ""overall satisfaction, lower denture']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0162686', 'cui_str': 'Dental prosthesis'}, {'cui': 'C3853359', 'cui_str': 'Edentulous mandible'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}]","[{'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0566339', 'cui_str': 'Ability to chew'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C0085801', 'cui_str': 'Factor Analysis'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",145.0,0.0931388,The 1st subset showed high inter-item correlation for most question combinations and no redundancy (r ≤ .8).,"[{'ForeName': 'Raphael F', 'Initials': 'RF', 'LastName': 'de Souza', 'Affiliation': 'Oral Health and Society, Faculty of Dentistry, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Adriana B', 'Initials': 'AB', 'LastName': 'Ribeiro', 'Affiliation': 'School of Dentistry, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Oates', 'Affiliation': 'School of Dentistry, University of Maryland, Baltimore, MD, USA.'}, {'ForeName': 'Jocelyne S', 'Initials': 'JS', 'LastName': 'Feine', 'Affiliation': 'Oral Health and Society, Faculty of Dentistry, McGill University, Montreal, QC, Canada.'}]",Gerodontology,['10.1111/ger.12477']
1378,32484952,Implicit play or explicit cognitive behaviour therapy: The impact of intervention approaches to facilitate social skills development in adolescents.,"INTRODUCTION


Early adolescence is a time of increased social interaction with peers. Social competence is related to pretend play ability in younger children, but a lack of pretend play ability in childhood may also be associated with social challenges in early adolescence. Adolescents who find social situations challenging experience alienation from peers resulting in lowered self-regard. This paper presents an exploratory study comparing an Implicit group intervention (age-appropriate play based group (PB)) to an Explicit group intervention Cognitive Behavioural Therapy (CBT) to increase social ability in adolescents.
METHODS


Six adolescents, three female and three male, were in the Implicit group (PB; mean age 12.3 years, SD = 1.21). Six male adolescents were in the Explicit group (CBT; mean age 13.3 years, SD = 1.03). All participants were assessed pre- and post the 8-week intervention for social competence, cognitive flexibility and narrative ability. The Implicit group (PB) was assessed through an age appropriate play assessment. Seven participants had a formal diagnosis, including autism spectrum disorder, and all were in mainstream high schools.
RESULTS


The Explicit group (CBT) showed a medium effect for social engagement, total social skills, emotional engagement and a large effect for a decrease in flexible thinking. The Implicit group (PB) showed a large impact for narrative ability with increases in ability to sequence events, initiation and creation of plot, understanding character roles and total movie score, with medium effects for generation of problems, precise vocabulary and use of symbols. The Implicit group (PB) maintained cognitive flexibility, and decreased in social self-scoring which showed medium effects for externalising and internalising.
CONCLUSION


This paper contributes to evidence that the choice of social skills intervention impacts different skill sets. For neuro-diverse adolescents, the cognitive intervention impacted social and emotional engagement and the play-based intervention impacted a wider range of abilities related to narrative social interaction.",2020,"The Explicit group (CBT) showed a medium effect for social engagement, total social skills, emotional engagement and a large effect for a decrease in flexible thinking.","['Six adolescents, three female and three male, were in the Implicit group (PB; mean age 12.3\xa0years, SD\xa0=\xa01.21', 'younger children', 'Seven participants had a formal diagnosis, including autism spectrum disorder, and all were in mainstream high schools', 'adolescents', 'Six male adolescents']","['Implicit group intervention (age-appropriate play based group (PB)) to an Explicit group intervention Cognitive Behavioural Therapy (CBT', 'Implicit play or explicit cognitive behaviour therapy']","['ability to sequence events, initiation and creation of plot, understanding character roles and total movie score, with medium effects for generation of problems, precise vocabulary and use of symbols', 'social competence, cognitive flexibility and narrative ability', 'flexible thinking', 'social engagement, total social skills, emotional engagement']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191283', 'cui_str': '12.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0024500', 'cui_str': 'Mainstreaming (Education)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0441513', 'cui_str': 'Construction'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",6.0,0.0174906,"The Explicit group (CBT) showed a medium effect for social engagement, total social skills, emotional engagement and a large effect for a decrease in flexible thinking.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Goldingay', 'Affiliation': 'School of Health and Social Development, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Stagnitti', 'Affiliation': 'School of Health and Social Development, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Narelle', 'Initials': 'N', 'LastName': 'Robertson', 'Affiliation': 'School of Health and Social Development, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Pepin', 'Affiliation': 'School of Health and Social Development, Deakin University, Geelong, Vic., Australia.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Sheppard', 'Affiliation': 'School of Allied Health, Australian Catholic University, Melbourne, Vic., Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Dean', 'Affiliation': 'School of Nursing and Midwifery, Deakin University, Geelong, Vic., Australia.'}]",Australian occupational therapy journal,['10.1111/1440-1630.12673']
1379,32599257,"A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data.","Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.",2020,"Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points.","['Patients with heart failure who are clinically eligible for an ICD are eligible for the study', 'Patients offered implantable Cardioverter-DEfibrillators', 'patients who have chronic progressive illness', '900 participants']","['implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation', 'shared DECision Support Intervention']",['decision quality (defined by knowledge and values-treatment concordance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C4517900', 'cui_str': '900'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.0983498,"Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points.","[{'ForeName': 'Bryan C', 'Initials': 'BC', 'LastName': 'Wallace', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Allen', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Advanced Heart Failure and Transplantation, Division of Cardiology, and Adult and Child Center for Health Outcomes Research and Delivery Science, School of Medicine, University of Colorado, Aurora, CO; Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Knoepke', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Glasgow', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO.'}, {'ForeName': 'Carmen L', 'Initials': 'CL', 'LastName': 'Lewis', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Fairclough', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Helmkamp', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Monica D', 'Initials': 'MD', 'LastName': 'Fitzgerald', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Wendy S', 'Initials': 'WS', 'LastName': 'Tzou', 'Affiliation': 'Advanced Heart Failure and Transplantation, Division of Cardiology, and Adult and Child Center for Health Outcomes Research and Delivery Science, School of Medicine, University of Colorado, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO; Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Kramer', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Varosy', 'Affiliation': 'Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO; Cardiology Section, VA Eastern Colorado Health Care System, Aurora, CO.'}, {'ForeName': 'Sanjaya K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': ""Saint Luke's Mid-America Heart Institute, Kansas City, MO.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Mandrola', 'Affiliation': 'Baptist Health Louisville, Louisville, KY.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Brancato', 'Affiliation': 'Providence Heart Institute, Portland, OR.'}, {'ForeName': 'Pamela N', 'Initials': 'PN', 'LastName': 'Peterson', 'Affiliation': 'Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO; Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Matlock', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO; Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, CO.'}]",American heart journal,['10.1016/j.ahj.2020.04.010']
1380,32605910,Circulating Tumor DNA is Prognostic and Potentially Predictive of Eryaspase Efficacy in Second-line in Patients with Advanced Pancreatic Adenocarcinoma.,"BACKGROUND


Eryaspase is composed of l-asparaginase encapsulated in erythrocytes and has demonstrated significant efficacy in a randomized phase II trial. We assessed the prognostic and predictive value of circulating tumor DNA (ctDNA) in patients, plasma included in this trial.
PATIENTS AND METHODS


Samples prospectively collected pretreatment were centrally analyzed by next-generation sequencing. Prognostic values of baseline ctDNA and ctDNA early changes between day 0 and 28 were assessed in both arms combined on objective response rate (ORR), progression-free survival (PFS), and overall survival (OS); three groups were defined: negative ctDNA (Neg), ctDNA responders (Resp), and ctDNA nonresponders (NResp). Predictive value of ctDNA for eryaspase efficacy was investigated.
RESULTS


ctDNA was positive at baseline in 77 patients of the 113 tested patients (68%). Detectable ctDNA was an independent negative prognostic factor for OS (4.6 vs. 8.8 months;  P  = 0.0025) and PFS (1.6 vs. 3.3 months;  P  = 0.00043). Early change in ctDNA levels was correlated with ORR (20%, 26%, 0%;  P  < 0.04), PFS (3.7, 3.4, 1.6 months;  P  < 0.0001), and OS (11.7, 6.5, 4.3 months;  P  < 0.0001) according to the three defined groups (Neg, Res, NResp, respectively). In patients with ctDNA detectable at baseline, eryaspase was associated with better PFS [HR = 0.53; 95% confidence interval (CI): 0.3-0.94)] and OS (HR = 0.52; 95% CI: 0.29-0.91).
CONCLUSIONS


We confirm from a prospective randomized trial that: (i) the presence of ctDNA at baseline is a major prognostic factor, (ii) the early change of ctDNA correlates with treatment outcome, and (iii) the ctDNA could be a predictive biomarker of eryaspase efficacy.",2020,Detectable ctDNA was an independent negative prognostic factor for OS (4.6 vs 8.8 months; p=0.0025) and PFS (1.6 vs 3.3 months; p=0.00043).,"['Samples prospectively collected pre-treatment were centrally analyzed by next-generation sequencing', '77 patients out of the 113 tested patients (68', 'patients plasma included in this trial', 'patients with advanced pancreatic adenocarcinoma']",[],"['objective response rate (ORR), progression free survival (PFS) and overall survival (OS', 'ctDNA levels', 'negative prognostic factor for OS', 'PFS']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2936621', 'cui_str': 'Next-Generation Sequencing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}]",[],"[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}]",113.0,0.147504,Detectable ctDNA was an independent negative prognostic factor for OS (4.6 vs 8.8 months; p=0.0025) and PFS (1.6 vs 3.3 months; p=0.00043).,"[{'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Sorbonne Université, UPMC Université, IUC, Paris, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Blons', 'Affiliation': 'Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Université, USPC, Université de Paris, Equipe labellisée Ligue Nationale contre le cancer, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, Université de Paris, Medical Oncology Unit, Hôpital Beaujon, Clichy, France.'}, {'ForeName': 'Iman El', 'Initials': 'IE', 'LastName': 'Hariry', 'Affiliation': 'ERYTECH, Cambridge, Massachusettts.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Portales', 'Affiliation': 'Parc Euromedecine, Montpellier, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mineur', 'Affiliation': 'Institut Sainte Catherine, Gastrointestinal and Liver Cancer Unit, Chemin de baigne pieds, Avignon, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Metges', 'Affiliation': 'CHRU de Brest, Hôpital Morvan, Brest, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Mulot', 'Affiliation': 'Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Université, USPC, Université de Paris, Equipe labellisée Ligue Nationale contre le cancer, Paris, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Bourreau', 'Affiliation': 'Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Université, USPC, Université de Paris, Equipe labellisée Ligue Nationale contre le cancer, Paris, France.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Cain', 'Affiliation': 'ERYTECH, Cambridge, Massachusettts.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Cros', 'Affiliation': 'Assistance Publique-Hôpitaux de Paris, INSERM, Paris University, Department of Pathology Hôpital Beaujon, Clichy, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Laurent-Puig', 'Affiliation': 'Centre de Recherche des Cordeliers, INSERM, CNRS, Sorbonne Université, USPC, Université de Paris, Equipe labellisée Ligue Nationale contre le cancer, Paris, France. pierre.laurent-puig@parisdescartes.fr.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0950']
1381,32606055,Supervised treatment in outpatients for schizophrenia plus (STOPS+): protocol for a cluster randomised trial of a community-based intervention to improve treatment adherence and reduce the treatment gap for schizophrenia in Pakistan.,"INTRODUCTION


There is a significant treatment gap, with only a few community-based services for people with schizophrenia in low-income and middle-income countries. Poor treatment adherence in schizophrenia is associated with poorer health outcomes, suicide attempts and death. We previously reported the effectiveness of supervised treatment in outpatients for schizophrenia (STOPS) for improving treatment adherence in patients with schizophrenia. However, STOPS was evaluated in a tertiary care setting with no primary care involvement, limiting its generalisability to the wider at-risk population. We aim to evaluate the effectiveness of STOPS+ in scaling up the primary care treatment of schizophrenia to a real-world setting.
METHODS AND ANALYSIS


The effectiveness of the STOPS+ intervention in improving the level of functioning and medication adherence in patients with schizophrenia in Pakistan will be evaluated using a cluster randomised controlled trial design. We aim to recruit 526 participants from 24 primary healthcare centres randomly allocated in 1:1 ratio to STOPS+ intervention and enhanced treatment as usual arms. Participants will be followed-up for 12 months postrecruitment. The sample size is estimated for two outcomes (1) the primary clinical outcome is level of functioning, measured using the Global Assessment of Functioning scale and (2) the primary process outcome is adherence to treatment regimen measured using a validated measure. An intention-to-treat approach will be used for the primary analysis.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from Keele University Ethical Review Panel (ref: MH-190017) and Khyber Medical University Ethical Review Board (ref: DIR-KMU-EB/ST/000648). The results of the STOPS+ trial will be reported in peer-reviewed journals and academic conferences and disseminated to local stakeholders and policymakers.
TRIAL REGISTRATION NUMBER


ISRCTN93243890.",2020,The effectiveness of the STOPS+ intervention in improving the level of functioning and medication adherence in patients with schizophrenia in Pakistan will be evaluated using a cluster randomised controlled trial design.,"['patients with schizophrenia in Pakistan', 'schizophrenia in Pakistan', 'outpatients for schizophrenia (STOPS', 'patients with schizophrenia', '526 participants from 24 primary healthcare centres randomly allocated in 1:1 ratio to', 'outpatients for schizophrenia plus (STOPS']","['STOPS+ intervention', 'STOPS+ intervention\u2009and enhanced treatment as usual arms', 'STOPS']","['level of functioning, measured using the Global Assessment of Functioning scale and (2) the primary process outcome is adherence to treatment regimen', 'level of functioning and medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",526.0,0.123963,The effectiveness of the STOPS+ intervention in improving the level of functioning and medication adherence in patients with schizophrenia in Pakistan will be evaluated using a cluster randomised controlled trial design.,"[{'ForeName': 'Thomas Andrew', 'Initials': 'TA', 'LastName': 'Shepherd', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Ul-Haq', 'Affiliation': 'Institute of Public Health & Social Sciences, Khyber Medical University, Peshawar, Khyber Pakhtunkhwa, Pakistan.'}, {'ForeName': 'Mian', 'Initials': 'M', 'LastName': 'Ul-Haq', 'Affiliation': 'Medical Teaching Institution, Lady Reading Hospital, Peshawar, Khyber Pakhtunkhwa, Pakistan.'}, {'ForeName': 'Muhammad Firaz', 'Initials': 'MF', 'LastName': 'Khan', 'Affiliation': 'Medical Teaching Institution, Lady Reading Hospital, Peshawar, Khyber Pakhtunkhwa, Pakistan.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Afridi', 'Affiliation': 'Medical Teaching Institution, Lady Reading Hospital, Peshawar, Khyber Pakhtunkhwa, Pakistan.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dikomitis', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Robinson', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Child Mental Health Unit, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Krysia', 'Initials': 'K', 'LastName': 'Dziedzic', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Umaima', 'Initials': 'U', 'LastName': 'Saeed', 'Affiliation': 'Institute of Public Health & Social Sciences, Khyber Medical University, Peshawar, Khyber Pakhtunkhwa, Pakistan.'}, {'ForeName': 'Naila Riaz', 'Initials': 'NR', 'LastName': 'Awan', 'Affiliation': 'Medical Teaching Institution, Lady Reading Hospital, Peshawar, Khyber Pakhtunkhwa, Pakistan.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mallen', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Farooq', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK s.farooq@keele.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-034709']
1382,32459987,Client memory and learning of treatment contents: An experimental study of intervention strategies and relationship to outcome in a brief treatment for procrastination.,"BACKGROUND AND OBJECTIVES


Client memory and learning is limited for psychological treatment contents. This study investigated different approaches to support client memory and learning of treatment contents and the relationship between memory and learning of treatment contents and outcome.
METHODS


Adult participants (n = 428) were recruited through Amazon's Mechanical Turk and randomized to complete one of three versions of a one-session procrastination intervention. Two versions of the intervention included different amounts of memory support strategy types from the Memory Support Intervention. A control version did not include any types of memory support. Memory and learning of treatment contents were assessed immediately after the intervention and one week later. Procrastination and two mechanisms of procrastination (impulsiveness and self-efficacy) were assessed at baseline and one week after the intervention.
RESULTS


Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention. Greater memory and learning of treatment contents predicted improvement in mechanisms of procrastination, but not procrastination itself.
LIMITATIONS


The mean level of procrastination in this study was lower than in other treatment studies of procrastination.
CONCLUSIONS


Results partially support the rationale for the Memory Support Intervention that improving client memory and learning of treatment contents can improve outcome. Findings suggest that the Memory Support Intervention may be simplified to include fewer strategies without compromising efficacy.",2020,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.",['Adult participants (n\xa0=\xa0428'],"[""Amazon's Mechanical Turk""]","['Memory and learning of treatment contents', 'procrastination (impulsiveness and self-efficacy', 'mean level of procrastination', 'Client memory and learning of treatment contents']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517775', 'cui_str': '428'}]","[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0871142', 'cui_str': 'Procrastination'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]",428.0,0.032357,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.","[{'ForeName': 'Garret G', 'Initials': 'GG', 'LastName': 'Zieve', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Woodworth', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'University of California, Berkeley, United States. Electronic address: aharvey@berkeley.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101579']
1383,32461104,Tumor mutational burden and immune infiltration as independent predictors of response to neoadjuvant immune checkpoint inhibition in early TNBC in GeparNuevo.,"BACKGROUND


The predictive value of tumor mutational burden (TMB), alone or in combination with an immune gene expression profile (GEP), for response to neoadjuvant therapy in early triple negative breast cancer (TNBC) is currently not known, either for immune checkpoint blockade (ICB) or conventional chemotherapy.
PATIENTS AND METHODS


We obtained both whole exome sequencing and RNA-Seq data from pretreatment samples of 149 TNBC of the recent neoadjuvant ICB trial, GeparNuevo. In a predefined analysis, we assessed the predictive value of TMB and a previously developed immune GEP for pathological complete remission (pCR).
RESULTS


Median TMB was 1.52 mut/Mb (range 0.02-7.65) and was significantly higher in patients with pCR (median 1.87 versus 1.39; P = 0.005). In multivariate analysis, odds ratios for pCR per mut/Mb were 2.06 [95% confidence intervals (CI) 1.33-3.20, P = 0.001] among all patients, 1.77 (95% CI 1.00-3.13, P = 0.049) in the durvalumab treatment arm, and 2.82 (95% CI 1.21-6.54, P = 0.016) in the placebo treatment arm, respectively. We also found that both continuous TMB and immune GEP (or tumor infiltrating lymphocytes) independently predicted pCR. When we stratified patients in groups based on the upper tertile of TMB and median GEP, we observed a pCR rate of 82% (95% CI 60% to 95%) in the group with both high TMB and GEP in contrast to only 28% (95% CI 16% to 43%) in the group with both low TMB and GEP.
CONCLUSIONS


TMB and immune GEP add independent value for pCR prediction. Our results recommend further analysis of TMB in combination with immune parameters to individually tailor therapies in breast cancer.",2020,"(95% CI 1.33-3.20, P=0.001) among all patients, 1.77 (95% CI 1.00-3.13, P=0.049) in the durvalumab treatment arm, and 2.82 (95% CI 1.21-6.54, P=0.016) in the placebo treatment arm, respectively.",['early triple negative breast cancer (TNBC'],[],"['pCR rate', 'Median TMB']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}]",[],"[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]",,0.160939,"(95% CI 1.33-3.20, P=0.001) among all patients, 1.77 (95% CI 1.00-3.13, P=0.049) in the durvalumab treatment arm, and 2.82 (95% CI 1.21-6.54, P=0.016) in the placebo treatment arm, respectively.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Karn', 'Affiliation': 'Goethe University, Frankfurt, Germany. Electronic address: t.karn@em.uni-frankfurt.de.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'University Hospital, Marburg, Germany.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Weber', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Holtrich', 'Affiliation': 'Goethe University, Frankfurt, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hanusch', 'Affiliation': 'Rotkreuzklinikum, Munich, Germany.'}, {'ForeName': 'B V', 'Initials': 'BV', 'LastName': 'Sinn', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Higgs', 'Affiliation': 'AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Jank', 'Affiliation': 'University Hospital, Marburg, Germany.'}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Sinn', 'Affiliation': 'University Hospital, Heidelberg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'University Hospital, Ulm, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Rotkreuzklinikum, Munich, Germany.'}, {'ForeName': 'J-U', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'University Hospital, Heidelberg, Germany.'}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Schmitt', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Mackelenbergh', 'Affiliation': 'University Hospital, Kiel, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'University Hospital, Hamburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schem', 'Affiliation': 'Mammazentrum, Hamburg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stickeler', 'Affiliation': 'University Hospital, Aachen, Germany.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Comprehensive Cancer Center, Friedrich-Alexander University, Erlangen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Sana Klinikum, Offenbach, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Helios Kliniken Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center of Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.015']
1384,32464334,"Prevalence, incidence, and natural history of HPV infection in adult women ages 24 to 45 participating in a vaccine trial.","OBJECTIVES


The natural history of human papillomavirus (HPV) infection has been studied extensively in young women; this study investigated HPV infection in adult women.
METHODS


Data from 3817 women aged 24-45 years in a global trial of the 4-valent HPV (6/11/16/18) vaccine were used to calculate prevalence of anogenital infections containing 9-valent (9v) HPV vaccine types (6/11/16/18/31/33/45/52/58) and five non-vaccine types (35/39/51/56/59). Incidence of infections and persistent infections was estimated for 989 placebo recipients naive to all 14 HPV types at baseline. Age-adjusted hazard ratios were calculated for various sociodemographic factors.
RESULTS


Prevalence of anogenital infection was highest in France at 29.2% (9vHPV types) and 21.7% (non-vaccine types) and lowest in the Philippines at 7.6% (9vHPV types) and 5.1% (non-vaccine types). Overall, HPV incidence (per 100 person-years) was 5.2 (9vHPV types) and 4.7 (non-vaccine types), and incidence of persistent infection was 2.7 (9vHPV types) and 2.1 (non-vaccine types). Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
CONCLUSIONS


Because mid-adult women acquire new HPV infections, administration of the 9vHPV vaccine could reduce HPV-related morbidity and mortality in this population.",2020,"Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
","['3817 women aged 24-45 years in a global trial of the 4-valent HPV (6/11/16/18', 'young women', 'adult women ages 24 to 45 participating in a vaccine trial', 'adult women']","['9vHPV vaccine', 'anogenital infections containing 9-valent (9v) HPV vaccine types (6/11/16/18/31/33/45/52/58) and five non-vaccine types (35/39/51/56/59', 'vaccine']","['Overall, HPV incidence', 'incidence of persistent infection', 'Prevalence of anogenital infection', 'Prevalence, incidence, and natural history of HPV infection', 'HPV-related morbidity and mortality', 'Incidence of infections and persistent infections']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1264606', 'cui_str': 'Persistent infection'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",3817.0,0.148337,"Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.
","[{'ForeName': 'Daron G', 'Initials': 'DG', 'LastName': 'Ferris', 'Affiliation': 'Department of Obstetrics and Gynecology, Georgia Cancer Center, 1120 15th Street, Augusta University, Augusta, GA, 30912, USA. Electronic address: dferris@augusta.edu.'}, {'ForeName': 'Darron R', 'Initials': 'DR', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Van Nuys Medical Science Building, Suite 224, 635 Barnhill Drive, Indianapolis, IN 46202, USA. Electronic address: darbrow@iupui.edu.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Giuliano', 'Affiliation': 'Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL, 33612, USA. Electronic address: Anna.Giuliano@moffitt.org.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Myers', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Duke Medicine Cir, Durham, NC, 27710, USA. Electronic address: evan.myers@duke.edu.'}, {'ForeName': 'Elmar A', 'Initials': 'EA', 'LastName': 'Joura', 'Affiliation': 'Department of Gynecology and Gynecological Oncology, Comprehensive Cancer Center, Weinheimergrass 2, Medical University of Vienna, Vienna, 1160, Austria. Electronic address: elmar.joura@gmail.com.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Garland', 'Affiliation': ""Centre for Women's Infectious Diseases, The Royal Women's Hospital, Department of Obstetrics and Gynaecology, University of Melbourne, Murdoch Children's Research Institute, RWH, Locked Bag 300, Cnr Gratton St and Flemington Rd, Parkville, Victoria, 3052, Australia. Electronic address: Suzanne.Garland@thewomens.org.au.""}, {'ForeName': 'Susanne K', 'Initials': 'SK', 'LastName': 'Kjaer', 'Affiliation': 'Danish Cancer Society Research Center, Copenhagen Denmark and Department of Gynecology, Rigshospitalet, Blegdamsvej 9, University of Copenhagen, Copenhagen, 2200, Denmark. Electronic address: susanne@cancer.dk.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Perez', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: gonzalopamaya@gmail.com.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Saah', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: alfred_saah@merck.com.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Luxembourg', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: alain_luxembourg@merck.com.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Velicer', 'Affiliation': 'Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ, 07033, USA. Electronic address: christine_velicer@merck.com.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100202']
1385,32470089,A pilot randomized trial of incentive strategies to promote HIV retesting in rural Uganda.,"BACKGROUND


Retesting for HIV is critical to identifying newly-infected persons and reinforcing prevention efforts among at-risk adults. Incentives can increase one-time HIV testing, but their role in promoting retesting is unknown. We sought to test feasibility and acceptability of incentive strategies, including commitment contracts, to promote HIV retesting among at-risk adults in rural Uganda.
METHODS


At-risk HIV-negative adults were enrolled in a pilot trial assessing feasibility and acceptability of incentive strategies to promote HIV retesting three months after enrollment. Participants were randomized (1:1:3) to: 1) no incentive; 2) standard cash incentive (~US$4); and 3) commitment contract: participants could voluntarily make a low- or high-value deposit that would be returned with added interest (totaling ~US$4 including the deposit) upon retesting or lost if participants failed to retest. Contracts sought to promote retesting by leveraging loss aversion and addressing present bias via pre-commitment. Outcomes included acceptability of trial enrollment, contract feasibility (proportion of participants making deposits), and HIV retesting uptake.
RESULTS


Of 130 HIV-negative eligible adults, 123 (95%) enrolled and were randomized: 74 (60%) to commitment contracts, 25 (20%) to standard incentives, and 24 (20%) to no incentive. Of contract participants, 69 (93%) made deposits. Overall, 93 (76%) participants retested for HIV: uptake was highest in the standard incentive group (22/25 [88%]) and lowest in high-value contract (26/36 [72%]) and no incentive (17/24 [71%]) groups.
CONCLUSION


In a randomized trial of strategies to promote HIV retesting among at-risk adults in Uganda, incentive strategies, including commitment contracts, were feasible and had high acceptability. Our findings suggest use of incentives for HIV retesting merits further comparison in a larger trial.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT:02890459.",2020,"Overall, 93 (76%) participants retested for HIV: uptake was highest in the standard incentive group (22/25 [88%]) and lowest in high-value contract (26/36 [72%]) and no incentive (17/24 [71%]) groups.
","['risk adults in rural Uganda', 'At-risk HIV-negative adults', '130 HIV-negative eligible adults, 123 (95%) enrolled', 'HIV retesting in rural Uganda']",['1) no incentive; 2) standard cash incentive (~US$4); and 3) commitment contract: participants could voluntarily make a low- or high-value deposit that would be returned with added interest (totaling ~US$4 including the deposit'],"['acceptability of trial enrollment, contract feasibility (proportion of participants making deposits), and HIV retesting uptake', 'HIV: uptake']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",130.0,0.175444,"Overall, 93 (76%) participants retested for HIV: uptake was highest in the standard incentive group (22/25 [88%]) and lowest in high-value contract (26/36 [72%]) and no incentive (17/24 [71%]) groups.
","[{'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Chamie', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Ndyabakira', 'Affiliation': 'Infectious Diseases Research Collaboration, Mbarara, Uganda.'}, {'ForeName': 'Kara G', 'Initials': 'KG', 'LastName': 'Marson', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Devy M', 'Initials': 'DM', 'LastName': 'Emperador', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'University of California, San Francisco, California, United States of America.'}, {'ForeName': 'Dalsone', 'Initials': 'D', 'LastName': 'Kwarisiima', 'Affiliation': 'Makerere University Joint AIDS Program, Kampala, Uganda.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, United States of America.'}]",PloS one,['10.1371/journal.pone.0233600']
1386,32473403,Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.,"Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate due to factors like distance and preferences, mirroring barriers in the general population. Practical alternatives to standard in-person programs are needed to improve access and engagement. A self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious in a general primary care population, may provide such an alternative. This pragmatic clinical trial will evaluate whether D-ELITE improves weight and general health status among Veterans with obesity, relative to VA usual care. The yearlong intervention includes one orientation by phone, supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions over 3 months, and continued self-directed weight management for months 4-12. Participants use MyFitnessPal.com or paper booklets for self-monitoring weight, diet, and physical activity. Follow-up assessments at 12 and 24 months are administered by mail or phone. The study hypothesis is that compared with usual care, D-ELITE will lead to greater improvements in 12-month weight loss, per VA electronic health records, and general physical health status, assessed using the self-reported SF-12 physical composite score. We will also explore D-ELITE's effects on secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact. If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.",2020,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","['veterans', 'Veterans with obesity, relative to VA usual care']","['supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions', 'self-directed lifestyle intervention', 'self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious']","['secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact', 'weight and general health status']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.02449,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","[{'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Hoerster', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; VA Puget Sound Healthcare System, Seattle Division, Mental Health Service, 1660 South Columbian Way (S-116), Seattle, WA 98108, United States; University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45(th) Street, Suite 300, Seattle, WA 98105, United States. Electronic address: Katherine.Hoerster@va.gov.'}, {'ForeName': 'Margaret P', 'Initials': 'MP', 'LastName': 'Collins', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Margaret.Collins@va.gov.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: David.Au@va.gov.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Amber.Lane2@va.gov.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Epler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Eric.Epler@va.gov.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McDowell', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Jennifer.McDowell@va.gov.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Barón', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 E. 17(th) Place, Aurora, CO 80045, United States. Electronic address: Anna.Baron@cuanschutz.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rise', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Peter.Rise@va.gov.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Plumley', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Robert.Plumley@va.gov.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Tanya.Nguyen@va.gov.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Schooler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Mary.Schooler@va.gov.'}, {'ForeName': 'Linnaea', 'Initials': 'L', 'LastName': 'Schuttner', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: Linnaea.Schuttner@va.gov.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'University of Illinois at Chicago, Department of Medicine, 1747 W. Roosevelt Rd, Room 586 (MC 275), Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106045']
1387,32474130,Randomized controlled trial protocol for project BRIDGE: A telephone-administered motivational interviewing intervention targeting risky sexual behavior in older people living with HIV.,"PURPOSE


By 2020, 70% of people living with HIV in the United States will be greater than 50 years of age. As many as 37% of sexually active older people living with HIV (OPLWH) engage in HIV transmission sexual behaviors. In spite of repeated calls for secondary prevention interventions to reduce condomless sex in OPLWH, no age-appropriate, evidence-based secondary prevention interventions exist for this group. Furthermore, many OPLWH face barriers to engaging in face-to-face secondary prevention services because of HIV- and age-related stigma, comorbid mental and physical health conditions that complicate travel, or geographic isolation. High rates of depression in OPLWH may further complicate engagement in interventions intended to reduce HIV transmissions. Telephone-administered motivational interviewing may be a feasible and efficacious intervention for this population.
METHODS


This randomized controlled trial will test the efficacy of a 5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention to reduce condomless sex in OPLWH. A diverse sample of 336 OPLWH will be recruited across the U.S. The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners. Secondary analyses will examine the efficacy of teleMI+BST to reduce depressive symptoms in mildly depressed OPLWH.
CONCLUSION


This is the first large-scale RCT intended to reduce HIV sexual transmission risk behavior in OPLWH and will add to the literature on secondary prevention telehealth interventions for people living with HIV. ClinicalTrials.gov Identifier: NCT03004170. This trial has been conducted by the approval of the Institutional Review Board. Participants provided verbal consent to participate in this trial.",2020,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"['older people living with HIV', 'people living with HIV', 'A diverse sample of 336 OPLWH will be recruited across the U.S']","['teleMI+BST', 'Telephone-administered motivational interviewing', '5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention', 'telephone-administered motivational interviewing intervention']",['depressive symptoms'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",336.0,0.216379,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kahler', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Heckman', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Huckans', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Feldstein Ewing', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Parsons', 'Affiliation': 'Mindful Designs, 791 Salem Street, Teaneck, NJ 07666, USA.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Phelps', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sutton', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Holloway', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Travis I', 'Initials': 'TI', 'LastName': 'Lovejoy', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA. Electronic address: lovejoy@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106047']
1388,32476640,"Effects of the  Rango Cards  game intervention on food consumption, nutritional knowledge and self-efficacy in the adoption of healthy eating practices of high school students: a cluster randomised controlled trial.","OBJECTIVE


The study aimed to assess the impact of a game-based nutritional intervention on food consumption, nutritional knowledge and self-efficacy in the adoption of healthy eating practices.
DESIGN


This cluster randomised controlled trial included both male and female high school students from private schools in the Federal District, Brazil. Four schools were randomly selected for each group. Investigated variables were age, sex, monthly family income, maternal education level, dietary perceptions and practices, nutritional knowledge and self-efficacy in the adoption of healthy eating practices.
SETTING


Intervention group participants were instructed to play Rango Cards, a digital game developed for the study, on their own, for a period of 7-17 d, while the control group was not provided with any game or material during the study.
PARTICIPANTS


The study included 319 adolescents (mean age = 15·8 (sd 0·7) years).
RESULTS


Significant reductions were observed in the intervention group compared with the control group for the following variables: habit of eating while watching TV or studying and having meals at fast food restaurants. The intervention group showed increased knowledge of the effects of fruit and vegetable consumption as well as improved self-efficacy in the adoption of healthy eating practices such as reducing Na intake and preparing healthy meals.
CONCLUSIONS


The design of Rango Cards is potentially capable of effecting positive changes. Therefore, the digital game promotes autonomy and self-care among adolescents with regard to healthy eating.",2020,"RESULTS


Significant reductions were observed in the intervention group compared with the control group for the following variables: habit of eating while watching TV or studying and having meals at fast food restaurants.","['The study included 319 adolescents (mean age = 15·8', 'healthy eating practices', 'adolescents with regard to healthy eating', 'healthy eating practices of high school students', 'male and female high school students from private schools in the Federal District, Brazil']","['play Rango Cards, a digital game', 'game-based nutritional intervention', 'Rango Cards  game intervention']","['knowledge of the effects of fruit and vegetable consumption', 'food consumption, nutritional knowledge and self-efficacy', 'self-efficacy']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0567466', 'cui_str': 'Eating practice'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",319.0,0.0509513,"RESULTS


Significant reductions were observed in the intervention group compared with the control group for the following variables: habit of eating while watching TV or studying and having meals at fast food restaurants.","[{'ForeName': 'Carolina Martins Dos Santos', 'Initials': 'CMDS', 'LastName': 'Chagas', 'Affiliation': 'Federal University of Lavras, Department of Nutrition,\xa0Minas Gerais37200-000, Brazil.'}, {'ForeName': 'Giselle Rhai-Sa', 'Initials': 'GR', 'LastName': 'Melo', 'Affiliation': 'University of Brasilia, School of Health Sciences, Graduate Program in Human Nutrition, Federal District, Brazil.'}, {'ForeName': 'Raquel Braz Assunção', 'Initials': 'RBA', 'LastName': 'Botelho', 'Affiliation': 'University of Brasilia, School of Health Sciences, Post-Graduate Program in Human Nutrition, Federal District, Brazil.'}, {'ForeName': 'Natacha', 'Initials': 'N', 'LastName': 'Toral', 'Affiliation': 'University of Brasilia, School of Health Sciences, Post-Graduate Program in Human Nutrition, Federal District, Brazil.'}]",Public health nutrition,['10.1017/S1368980020000531']
1389,32479559,Effects of singing bowl exposure on Karolinska sleepiness scale and pupillographic sleepiness test: A randomised crossover study.,"BACKGROUND


The aim of this study was to investigate the effects on subjective and objective sleepiness of a stay above a large struck singing bowl compared to a relaxation period in a silent singing bowl.
METHODS


Fifty-eight healthy subjects were recruited for the study, 48 participated on two days, one week apart, during the same timeslot. The Karolinska sleepiness scale was used to evaluate current subjective sleepiness, and the relative pupillary unrest index to assess objective sleepiness. In this randomized cross-over study, the intervention consisted of a 20-minute stay in a hammock while the singing bowl, positioned beneath, was struck seven times. The controlled comparator was a 20-minute stay in the same hammock above the singing bowl, but without being struck. After these two interventions subjective and objective sleepiness were re-evaluated.
RESULTS


The mean relative pupillary unrest index values after relaxation in the struck and silent singing bowl groups were 0.74 and respectively 0.71 (p = 0.460). The median Karolinska sleepiness scale value after relaxation with the struck singing bowl was 3 compared with 4 (p = 0.041) for the silent singing bowl.
DISCUSSION


This study evaluated the influence of a struck singing bowl on sleepiness during daytime. Subjective sleepiness was significantly lower after relaxation above a struck singing bowl. After gender stratification, the difference was still significant in women. Objective sleepiness was not different in both groups. Finally, we can only speculate if women may be more susceptible to subjective improvements in case of sleepiness and show another perception of relaxation in a struck singing bowl compared to men.",2020,The mean relative pupillary unrest index values after relaxation in the struck and silent singing bowl groups were 0.74 and respectively 0.71,"['Fifty-eight healthy subjects were recruited for the study, 48 participated on two days, one week apart, during the same timeslot']","['singing bowl exposure', 'struck singing bowl']","['Karolinska sleepiness scale', 'mean relative pupillary unrest index values', 'Karolinska sleepiness scale and pupillographic sleepiness test', 'Objective sleepiness', 'Subjective sleepiness', 'median Karolinska sleepiness scale value']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1442452', 'cui_str': 'One week'}]","[{'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C0336949', 'cui_str': 'Bowling'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0038452', 'cui_str': 'Employee Strikes'}]","[{'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0858854', 'cui_str': 'Unrest'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",58.0,0.0151798,The mean relative pupillary unrest index values after relaxation in the struck and silent singing bowl groups were 0.74 and respectively 0.71,"[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Bergmann', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Riedinger', 'Affiliation': 'Department of Therapeutic Radiology and Oncology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Stefani', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mitterling', 'Affiliation': 'Department of Neurology 1, Kepler University Hospital, Linz, Austria.'}, {'ForeName': 'Evi', 'Initials': 'E', 'LastName': 'Holzknecht', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Grassmayr', 'Affiliation': 'Bell Foundry Grassmayr, Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Högl', 'Affiliation': 'Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}]",PloS one,['10.1371/journal.pone.0233982']
1390,31843232,Effect of Serum Albumin Levels in Patients With Heart Failure With Preserved Ejection Fraction (from the TOPCAT Trial).,"Little data are available regarding the determinants and prognostic significance of serum albumin in Heart Failure with Preserved Ejection Fraction (HFpEF). We sought to examine the phenotypic correlates of albumin and its independent prognostic implications in HFpEF. We analyzed data from 3,254 subjects enrolled the TOPCAT trial. We stratified subjects according to tertiles of albumin and examined differences in various phenotypic traits between these strata, including 8 protein biomarkers selected ad hoc and measured from frozen samples available in a subset of participants (n = 372). We also assessed the relationship between albumin and the trial primary endpoint. Lower albumin was associated with older age, black race, and greater prevalence of NYHA class III-IV, peripheral arterial disease, atrial fibrillation and diabetes mellitus. Lower albumin was also associated with increased levels of several inflammatory biomarkers, markers of liver fibrosis, albuminuria, and greater arterial stiffness, diastolic dysfunction and pulmonary hypertension. Albumin was a strong predictor of the primary trial endpoint, even after adjustment for the MAGGIC risk score (hazard ratio [HR] 0.72, confidence interval [CI] 0.67 to 0.78; p <0.0001) and prespecified traditional risk factors (HR 0.78, CI 0.71 to 0.85; p <0.0001). Lower albumin was strongly associated with a worse prognosis even well within normal ranges (>3.5 g/dL), with a sharp increase in risk between 4.6 and 3.6 g/dL. In conclusion, albumin is an integrated marker of various adverse processes in HFpEF, including inflammation, subclinical liver disease, arterial stiffness, and renal disease. Albumin is a powerful risk predictor independent of traditional risk prediction models, even within normal ranges.",2020,"Lower albumin was strongly associated with a worse prognosis even well within normal ranges (>3.5 g/dL), with a sharp increase in risk between 4.6 and 3.6 g/dL. In conclusion, albumin is an integrated marker of various adverse processes in HFpEF, including inflammation, subclinical liver disease, arterial stiffness, and renal disease.","['3,254 subjects enrolled the TOPCAT trial', 'Patients With Heart Failure With Preserved Ejection Fraction (from the TOPCAT Trial']",[],"['levels of several inflammatory biomarkers, markers of liver fibrosis, albuminuria, and greater arterial stiffness, diastolic dysfunction and pulmonary hypertension', 'Serum Albumin Levels']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}]",3254.0,0.0639009,"Lower albumin was strongly associated with a worse prognosis even well within normal ranges (>3.5 g/dL), with a sharp increase in risk between 4.6 and 3.6 g/dL. In conclusion, albumin is an integrated marker of various adverse processes in HFpEF, including inflammation, subclinical liver disease, arterial stiffness, and renal disease.","[{'ForeName': 'Stuart B', 'Initials': 'SB', 'LastName': 'Prenner', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Cvijic', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Basso', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Spires', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Zhuyin', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Yarde', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Priyanka', 'Initials': 'P', 'LastName': 'Bhattacharya', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Payman', 'Initials': 'P', 'LastName': 'Zamani', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Mazurek', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania.'}, {'ForeName': 'Zhaoqing', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Seiffert', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Gordon', 'Affiliation': 'Bristol-Myers Squibb Company, Pennington and Lawrenceville, New Jersey.'}, {'ForeName': 'Julio A', 'Initials': 'JA', 'LastName': 'Chirinos', 'Affiliation': 'Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania; University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania. Electronic address: julio.chirinos@uphs.upenn.edu.'}]",The American journal of cardiology,['10.1016/j.amjcard.2019.11.006']
1391,32584630,Efficacy and Safety of Vandetanib in Progressive and Symptomatic Medullary Thyroid Cancer: Post Hoc Analysis From the ZETA Trial.,"PURPOSE


We conducted a post hoc analysis of the vandetanib phase III trial involving patients with advanced medullary thyroid cancer (MTC) to assess the efficacy and safety of vandetanib in patients with progressive and symptomatic MTC. The primary objective of the analysis was to determine progression-free survival (PFS) of these patients.
PATIENTS AND METHODS


Eligible patients from the ZETA trial were divided into 4 disease severity subgroups: progression and symptoms, symptoms only, progression only, and no progression and no symptoms assessed at baseline. PFS, determined from objective tumor measurements performed by the local investigator, overall survival (OS), time to worsening of pain (TWP), and objective response rate (ORR) were evaluated.
RESULTS


Of the 331 patients in this trial, 184 had symptomatic and progressive disease at baseline. In this subgroup, results were similar in magnitude to those observed in the overall trial for PFS (hazard ratio [HR], 0.43; 95% CI, 0.28 to 0.64;  P  < .0001), OS (HR, 1.08; 95% CI, 0.72 to 1.61;  P  = .71), and TWP (HR, 0.67; 95% CI, 0.43 to 1.04;  P  = .07), and the observed adverse events were consistent with the known safety profile of vandetanib. In this subgroup, the ORR was 37% in the treatment arm versus 2% in the placebo arm.
CONCLUSION


Vandetanib demonstrated clinical benefit-specifically, increased PFS-in patients with symptomatic and progressive MTC.",2020,"In this subgroup, results were similar in magnitude to those observed in the overall trial for PFS (hazard ratio [HR], 0.43; 95% CI, 0.28 to 0.64;  P  < .0001), OS (HR, 1.08; 95% CI, 0.72 to 1.61;  P  = .71), and TWP (HR, 0.67; 95% CI, 0.43 to 1.04;  P  = .07), and the observed adverse events were consistent with the known safety profile of vandetanib.","['Eligible patients from the ZETA trial were divided into 4 disease severity subgroups: progression and symptoms, symptoms only, progression only, and no progression and no symptoms assessed at baseline', 'patients with symptomatic and progressive MTC', 'Progressive and Symptomatic Medullary Thyroid Cancer', '331 patients in this trial, 184 had symptomatic and progressive disease at baseline', 'patients with progressive and symptomatic MTC', 'patients with advanced medullary thyroid cancer (MTC']",['Vandetanib'],"['progression-free survival (PFS', 'Efficacy and Safety', 'overall survival (OS), time to worsening of pain (TWP), and objective response rate (ORR', 'ORR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1719914', 'cui_str': 'Zeta'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0238462', 'cui_str': 'Medullary thyroid carcinoma'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C1121849', 'cui_str': 'Vandetanib'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",331.0,0.29884,"In this subgroup, results were similar in magnitude to those observed in the overall trial for PFS (hazard ratio [HR], 0.43; 95% CI, 0.28 to 0.64;  P  < .0001), OS (HR, 1.08; 95% CI, 0.72 to 1.61;  P  = .71), and TWP (HR, 0.67; 95% CI, 0.43 to 1.04;  P  = .07), and the observed adverse events were consistent with the known safety profile of vandetanib.","[{'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Kreissl', 'Affiliation': 'Department of Radiology and Nuclear Medicine, University Hospital of Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bastholt', 'Affiliation': 'Department of Clinical Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Elisei', 'Affiliation': 'Department of Clinical and Experimental Medicine, Unit of Endocrinology University of Pisa, Pisa, Italy.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': 'Dana Farber Cancer Institute, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Hauch', 'Affiliation': 'Hauch Consultancy, Brussels, Belgium.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Jarząb', 'Affiliation': 'Department of Nuclear Medicine and Endocrine Oncology, Maria Sklodowska-Curie National Research Institute of Oncology Gliwice Branch, Gliwice, Poland.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Robinson', 'Affiliation': 'Sydney Medical School, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Colzani', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Foster', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Weiss', 'Affiliation': 'Department of Nuclear Medicine and Endocrine Oncology, Gustave Roussy, Université Paris Saclay, Villejuif, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schlumberger', 'Affiliation': 'Department of Nuclear Medicine and Endocrine Oncology, Gustave Roussy, Université Paris Saclay, Villejuif, France.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02790']
1392,32590057,Maternal Mindfulness Is Associated With Lower Child Body Mass Index Z Score.,"BACKGROUND


Parental mindfulness may be a novel intervention target for child obesity prevention.
OBJECTIVE


To examine associations between maternal mindfulness and child body mass index z-score (BMIz).
METHODS


In a secondary data analysis of preintervention data from a randomized controlled trial, we assessed survey and anthropometric data from English-speaking mother/child dyads enrolled in Head Start in south central Michigan (n = 105). Surveys included demographic information, child dietary intake, family meal frequency, and the Philadelphia Mindfulness Questionnaire. Multivariable linear regression examined associations between maternal mindfulness and child BMIz, child intake of fruits and vegetables, and frequency of family meals.
RESULTS


Children were M = 53.7 (standard deviation [SD] 7.5) months old, and mothers were M = 31.6 (SD 8.3) years old. The sample of children was 39% white, 26% black, 14% Hispanic, and 35% of children were overweight or obese. Mean maternal BMI was 32.0 (SD 8.3). Greater mindfulness was associated with child BMIz (β = -.02 (SE 0.01), P = .027) adjusting for child race/ethnicity, household food security, maternal education, maternal age, and maternal BMI. Mindfulness was not associated with child fruit intake, child vegetable intake or frequency of family meals. The results were consistent with alternative outcomes of BMI percentile (P = .016) and BMI at the trend level (P = .0595) at the trend level.
CONCLUSIONS


Greater maternal mindfulness was associated with lower child BMIz. Future work should consider mechanisms of association. Pediatric providers might consider supporting maternal mindfulness as one element of multicomponent strategies for child obesity prevention.",2020,"The results were consistent with alternative outcomes of BMI percentile (p=.016) and BMI at the trend level (p=.0595) at the trend level.
","['Children were M=53.7 (SD 7.5) months old, and mothers were M=31.6 (SD 8.3) years old', 'sample of children was 39% white, 26% black, 14% Hispanic, and 35% of children were overweight or obese', 'English-speaking mother/child dyads enrolled in Head Start in south central Michigan (n=105']",[],"['Lower Child Body Mass Index Z score', 'maternal mindfulness and child body mass index z-score (BMIz', 'demographic information, child dietary intake, family meal frequency, and the Philadelphia Mindfulness Questionnaire', 'maternal mindfulness and child BMIz, child intake of fruits and vegetables, and frequency of family meals', 'child fruit intake, child vegetable intake or frequency of family meals', 'Mean maternal BMI', 'child BMIz', 'BMI percentile']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}, {'cui': 'C0556223', 'cui_str': 'Vegetable intake'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}]",,0.0182683,"The results were consistent with alternative outcomes of BMI percentile (p=.016) and BMI at the trend level (p=.0595) at the trend level.
","[{'ForeName': 'Chioma', 'Initials': 'C', 'LastName': 'Torres', 'Affiliation': 'Department of Pediatrics, University of Michigan Medical School (C Torres, J Struza, and JC Lumeng), Ann Arbor, Mich. Electronic address: ochioma@med.umich.edu.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Brophy-Herb', 'Affiliation': 'Department of Human Development and Family Studies, Michigan State University (HE Brophy-Herb, JM Williams, and HH Choi), East Lansing, Mich.'}, {'ForeName': 'Harlan', 'Initials': 'H', 'LastName': 'McCaffery', 'Affiliation': 'Center for Human Growth and Development, University of Michigan (H McCaffery, N Kaciroti, and JC Lumeng), Ann Arbor, Mich.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Struza', 'Affiliation': 'Department of Pediatrics, University of Michigan Medical School (C Torres, J Struza, and JC Lumeng), Ann Arbor, Mich.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': 'Department of Human Development and Family Studies, Michigan State University (HE Brophy-Herb, JM Williams, and HH Choi), East Lansing, Mich.'}, {'ForeName': 'Hailey Hyunjin', 'Initials': 'HH', 'LastName': 'Choi', 'Affiliation': 'Department of Human Development and Family Studies, Michigan State University (HE Brophy-Herb, JM Williams, and HH Choi), East Lansing, Mich.'}, {'ForeName': 'Mildred A', 'Initials': 'MA', 'LastName': 'Horodynski', 'Affiliation': 'College of Nursing, Michigan State University (MA Horodynski), East Lansing, Mich.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Contreras', 'Affiliation': 'Michigan State University Extension, Michigan State University (D Contreras), East Lansing, Mich.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Kerver', 'Affiliation': 'Department of Epidemiology and Biostatistics, Michigan State University (J Kerver), East Lansing, Mich.'}, {'ForeName': 'Niko', 'Initials': 'N', 'LastName': 'Kaciroti', 'Affiliation': 'Center for Human Growth and Development, University of Michigan (H McCaffery, N Kaciroti, and JC Lumeng), Ann Arbor, Mich.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Lumeng', 'Affiliation': 'Department of Pediatrics, University of Michigan Medical School (C Torres, J Struza, and JC Lumeng), Ann Arbor, Mich; Center for Human Growth and Development, University of Michigan (H McCaffery, N Kaciroti, and JC Lumeng), Ann Arbor, Mich; Department of Nutritional Sciences, University of Michigan School of Public Health (JC Lumeng), Ann Arbor, Mich.'}]",Academic pediatrics,['10.1016/j.acap.2020.06.012']
1393,32591170,"Targeting Cognitive Control Deficits With Neuroplasticity-Based Computerized Cognitive Remediation in Patients With Geriatric Major Depression: A Randomized, Double-Blind, Controlled Trial.","Late life major depression (LLD) is often accompanied by cognitive deficits. When patients have specific deficits in cognitive control functions (CCD), they are not only distressing and debilitating, they often predict poor clinical outcomes such as reduced response to SSRI/SNRI antidepressants, increased disability, suicide and all-cause mortality. We recently reported that in an open label trial, our treatment designed to target these specific CCD with neuroplasticity-based computerized cognitive remediation (nCCR) improved depression and CCD in patients who failed to remit with conventional antidepressant treatment. This study tested the hypothesis that in patients with LLD who have failed at least one trial of an SSRI/SNRI antidepressant at an adequate dose for at least 8 weeks, nCCR will improve both depressive symptoms and the CCD associated with poor antidepressant response (i.e. semantic strategy, inhibition of prepotent responses) more than an active control group. Participants were randomized (1:1) to receive either 30 hours/ 4 weeks of neuroplasticity based computerized cognitive remediation (nCCR) designed to target CCD, or the active control condition matched for duration, engagement, reward, computer presentation, and contact with study staff. All participants and raters were blinded. Mixed effects model analysis the time effect (week) (F(1,71.22)=25.2, p<0.0001) and treatment group X time interaction (F(1,61.8)=11.37, p=.002) reached significance indicating that the slope of decline in MADRS was steeper in the nCCR-GD group. Further, the nCCR group improved their semantic clustering strategy(t(28)=9.5; p=.006), as well as performance on the Stroop interference condition, and cognitive flexibility (Trails B). Further, results transferred to memory performance, which was not a function trained by nCCR. clinicaltrials.gov.",2020,"Further, the nCCR group improved their semantic clustering strategy(t(28)=9.5; p=.006), as well as performance on the Stroop interference condition, and cognitive flexibility (Trails B).","['With Geriatric Major Depression', 'patients who failed to remit with conventional antidepressant treatment', 'patients with LLD who have failed at least one trial of an', 'Patients']","['neuroplasticity-based computerized cognitive remediation (nCCR', '30 hours/ 4 weeks of neuroplasticity based computerized cognitive remediation (nCCR) designed to target CCD, or the active control condition matched for duration, engagement, reward, computer presentation, and contact with study staff', 'Neuroplasticity-Based Computerized Cognitive Remediation', 'SSRI/SNRI antidepressant']","['Stroop interference condition, and cognitive flexibility (Trails B', 'MADRS', 'Late life major depression (LLD']","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008928', 'cui_str': 'Cleidocranial dysostosis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C1579361', 'cui_str': 'SSRIs and NRIs'}]","[{'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]",,0.145174,"Further, the nCCR group improved their semantic clustering strategy(t(28)=9.5; p=.006), as well as performance on the Stroop interference condition, and cognitive flexibility (Trails B).","[{'ForeName': 'Sarah Shizuko', 'Initials': 'SS', 'LastName': 'Morimoto', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City UT; Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT. Electronic address: sarah.morimoto@hsc.utah.edu.'}, {'ForeName': 'Roger Alan', 'Initials': 'RA', 'LastName': 'Altizer', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City UT; Therapeutic Games and Apps Lab, Department of Entertainment Arts and Engineering, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Faith M', 'Initials': 'FM', 'LastName': 'Gunning', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT.'}, {'ForeName': 'Willie', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT.'}, {'ForeName': 'Jiacheng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Zhongda Hospital, Medical School of Southeast University, Nanjing, China.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Cote', 'Affiliation': 'Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City UT.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Nitis', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': 'Weill Cornell Institute of Geriatric Psychiatry, White Plains, Salt Lake City, UT.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.05.023']
1394,32464527,Community-level interventions for pre-eclampsia (CLIP) in Mozambique: A cluster randomised controlled trial.,"OBJECTIVES


Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment.
STUDY DESIGN


The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of CLIP contacts.
MAIN OUTCOME MEASURES


20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity.
RESULTS


15,013 women (15,123 pregnancies) were recruited in intervention (N = 7930; 2·0% loss to follow-up (LTFU)) and control (N = 7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40). Compared with intervention arm women without CLIP contacts, those with ≥8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p = 0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p = 0·033).
INTERPRETATION


As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial.
FUNDING


The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","['pre-eclampsia (CLIP) in Mozambique', 'pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces', '15,013 women (15,123 pregnancies']","['CLIP intervention', 'task-sharing care', 'CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently', 'Community-level interventions', 'Mozambique Community-Level Interventions']","['maternal outcomes', 'composite of maternal, fetal, and newborn mortality and major morbidity', 'safety and evaluation of the intensity of CLIP contacts']","[{'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",15013.0,0.295538,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","[{'ForeName': 'Esperança', 'Initials': 'E', 'LastName': 'Sevene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique. Electronic address: esperanca.sevene@manhica.net.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Khátia', 'Initials': 'K', 'LastName': 'Munguambe', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Charfudin', 'Initials': 'C', 'LastName': 'Sacoor', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Anifa', 'Initials': 'A', 'LastName': 'Vala', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Salésio', 'Initials': 'S', 'LastName': 'Macuacua', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Direcção Provincial de Saúde, Ministério da Saúde, Av. Eduardo Mondlane n(o) 1008, CP 264 Maputo, Mozambique.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Boene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Orvalho', 'Initials': 'O', 'LastName': 'Augusto', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Cassimo', 'Initials': 'C', 'LastName': 'Bique', 'Affiliation': 'Departamento de Ginecologia e Obstetrícia, Hospital Central de Maputo, Av. Agostinho Neto n(o) 167, CP 1164 Maputo, Mozambique.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Eusébio', 'Initials': 'E', 'LastName': 'Macete', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Instituto Nacional de Saúde, Ministério da Saúde, Distrito de Marracuene, Estrada Nacional N(o) 1, Maputo, Mozambique.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Sidat', 'Affiliation': 'Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Corssino', 'Initials': 'C', 'LastName': 'Tchavana', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.006']
1395,32470389,Intensity of Renal Replacement Therapy and Duration of Mechanical Ventilation: Secondary Analysis of the Acute Renal Failure Trial Network Study.,"BACKGROUND


Randomized clinical trials have failed to show benefit from increasing intensity of renal replacement therapy (RRT) for acute kidney injury, but continue to be frequently used. In addition, intensive RRT is associated with an increase in adverse events potentially secondary to small solute losses, such as phosphate. We hypothesized that, compared with less-intensive RRT, intensive RRT would lead to longer duration of mechanical ventilation.
RESEARCH QUESTION


Does more-intensive renal replacement therapy in critically ill patients with acute kidney injury increase time to extubation from mechanical ventilation when compared with less-intensive therapy?
STUDY DESIGN AND METHODS


The Acute Renal Failure Trial Network study was a randomized multicenter trial of more-intensive (hemodialysis or sustained low-efficiency dialysis six times per week or continuous venovenous hemodiafiltration at 35 mL/kg per hour) vs less-intensive (hemodialysis or sustained low-efficiency dialysis three times per week or continuous venovenous hemodiafiltration at 20 mL/kg per hour) RRT in critically ill patients with acute kidney injury. Of 1124 patients, 907 who were supported by mechanical ventilation on study initiation were included in this Cox-proportional hazards analysis. The primary outcome was the time to first successful extubation off mechanical ventilation.
RESULTS


Patients who were assigned randomly to more-intensive RRT had a 33.3% lower hazard rate of successful extubation (hazard ratio, 0.67; 95% CI, 0.52-0.88; P < .001) when compared with patients who were assigned to less-intensive RRT. Patients who were assigned to more-intensive RRT had, on average, 2.07 ventilator-free days, compared with 3.08 days in those who were assigned to less-intensive RRT (P < .001) over 14 days from start of the study.
INTERPRETATION


Critically ill mechanically ventilated patients who were assigned randomly to more-intensive RRT had longer duration of mechanical ventilation compared with those who were assigned to less-intensive RRT. The reasons for this, such as excessive phosphate loss from more-intensive RRT, deserve further study to optimize the safety and effectiveness of CRRT delivery. This was a post hoc analysis of the Acute Renal Failure Trial Network study; clinical trial registration of the original trial is NCT00076219.",2020,"RESULTS


Patients randomized to more intensive RRT had a 33.3% lower hazard rate of successful extubation (HR 0.67, 95% CI 0.52 - 0.88, P<0.001) when compared to patients randomized to less-intensive RRT.","['Of 1124 patients, 907 who were supported by mechanical ventilation on study initiation', 'critically ill patients', 'critically ill patients with AKI']","['renal replacement therapy (RRT', 'intensive (hemodialysis or sustained low-efficiency dialysis six times per week or continuous venovenous hemodiafiltration at 35 ml/kg per hour) versus less-intensive (hemodialysis or sustained low-efficiency dialysis three times per week or continuous venovenous hemodiafiltration', 'intensive RRT', 'RRT', 'Renal Replacement Therapy and Duration of Mechanical Ventilation']","['time to first successful extubation off mechanical ventilation', 'hazard rate of successful extubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}]","[{'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0472688', 'cui_str': 'Continuous venovenous hemodiafiltration'}, {'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0564385', 'cui_str': '/hour'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]",1124.0,0.192189,"RESULTS


Patients randomized to more intensive RRT had a 33.3% lower hazard rate of successful extubation (HR 0.67, 95% CI 0.52 - 0.88, P<0.001) when compared to patients randomized to less-intensive RRT.","[{'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Division of Nephrology, David Geffen School of Medicine at UCLA, Los Angeles, CA; Veterans Affairs, Greater Los Angeles Healthcare System, Los Angeles, CA. Electronic address: shilpasharma@mail.harvard.edu.""}, {'ForeName': 'Yvelynne P', 'Initials': 'YP', 'LastName': 'Kelly', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Palevsky', 'Affiliation': 'Renal Section, Veterans Affairs Pittsburgh Healthcare System, and the Renal-Electrolyte Division, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA.'}, {'ForeName': 'Sushrut S', 'Initials': 'SS', 'LastName': 'Waikar', 'Affiliation': ""Renal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Section of Nephrology, Boston University School of Medicine and Boston Medical Center, Boston, MA.""}]",Chest,['10.1016/j.chest.2020.05.542']
1396,32470421,"Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study.","BACKGROUND


Deep brain stimulation (DBS) of the subthalamic nucleus is an established therapeutic option for managing motor symptoms of Parkinson's disease. We conducted a double-blind, sham-controlled, randomised controlled trial to assess subthalamic nucleus DBS, with a novel multiple independent contact current-controlled (MICC) device, in patients with Parkinson's disease.
METHODS


This trial took place at 23 implanting centres in the USA. Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent. Patients who passed screening criteria were implanted with the DBS device bilaterally in the subthalamic nucleus. Patients were randomly assigned in a 3:1 ratio to receive either active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group) for the 3-month blinded period. Randomisation took place with a computer-generated data capture system using a pre-generated randomisation table, stratified by site with random permuted blocks. During the 3-month blinded period, both patients and the assessors were masked to the treatment group while the unmasked programmer was responsible for programming and optimisation of device settings. The primary outcome was the difference in mean change from baseline visit to 3 months post-randomisation between the active and control groups in the mean number of waking hours per day with good symptom control and no troublesome dyskinesias, with no increase in anti-parkinsonian medications. Upon completion of the blinded phase, all patients received active treatment in the open-label period for up to 5 years. Primary and secondary outcomes were analysed by intention to treat. All patients who provided informed consent were included in the safety analysis. The open-label phase is ongoing with no new enrolment, and current findings are based on the prespecified interim analysis of the first 160 randomly assigned patients. The study is registered with ClinicalTrials.gov, NCT01839396.
FINDINGS


Between May 17, 2013, and Nov 30, 2017, 313 patients were enrolled across 23 sites. Of these 313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned. Of the 160 patients included in the interim analysis, 121 (76%) were randomly assigned to the active group and 39 (24%) to the control group. The difference in mean change from the baseline visit (post-implant) to 3 months post-randomisation in increased ON time without troublesome dyskinesias between the active and control groups was 3·03 h (SD 4·52, 95% CI 1·3-4·7; p<0·0001). 26 serious adverse events in 20 (13%) patients occurred during the 3-month blinded period. Of these, 18 events were reported in the active group and 8 in the control group. One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
INTERPRETATION


This double-blind, sham-controlled, randomised controlled trial provides class I evidence of the safety and clinical efficacy of subthalamic nucleus DBS with a novel MICC device for the treatment of motor symptoms of Parkinson's disease. Future trials are needed to investigate potential benefits of producing a more defined current field using MICC technology, and its effect on clinical outcomes.
FUNDING


Boston Scientific.",2020,"One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
","['313 patients, 196 (63%) received the DBS implant and 191 (61%) were randomly assigned', '23 implanting centres in the USA', ""patients with Parkinson's disease"", ""motor symptoms of Parkinson's disease"", '160 patients included in the interim analysis, 121 (76', 'Between May 17, 2013, and Nov 30, 2017', '313 patients were enrolled across 23 sites', ""Parkinson's disease (INTREPID"", ""Key inclusion criteria were age between 22 and 75 years, a diagnosis of idiopathic Parkinson's disease with over 5 years of motor symptoms, and stable use of anti-parkinsonian medications for 28 days before consent""]","['subthalamic nucleus DBS with a novel MICC device', 'Subthalamic nucleus deep brain stimulation', 'Deep brain stimulation (DBS', 'active therapeutic stimulation settings (active group) or subtherapeutic stimulation settings (control group', 'novel multiple independent contact current-controlled (MICC) device']","['ON time without troublesome dyskinesias', 'anti-parkinsonian medications', 'mean number of waking hours per day with good symptom control and no troublesome dyskinesias', '26 serious adverse events', 'mean change from baseline visit to 3 months post-randomisation']","[{'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0556974', 'cui_str': 'hours/day'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}]",313.0,0.575314,"One death was reported among the 196 patients before randomisation, which was unrelated to the procedure, device, or stimulation.
","[{'ForeName': 'Jerrold L', 'Initials': 'JL', 'LastName': 'Vitek', 'Affiliation': 'Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA. Electronic address: vitek004@umn.edu.'}, {'ForeName': 'Roshini', 'Initials': 'R', 'LastName': 'Jain', 'Affiliation': 'Division of Neuromodulation, Boston Scientific, Valencia, CA, USA.'}, {'ForeName': 'Lilly', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Neuromodulation, Boston Scientific, Valencia, CA, USA.'}, {'ForeName': 'Alexander I', 'Initials': 'AI', 'LastName': 'Tröster', 'Affiliation': 'Department of Clinical Neuropsychology, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Schrock', 'Affiliation': 'Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'House', 'Affiliation': 'Neurosurgical Associates, Murray, UT, USA.'}, {'ForeName': 'Monique L', 'Initials': 'ML', 'LastName': 'Giroux', 'Affiliation': 'Movement and Neuroperformance Center of Colorado, Englewood, CO, USA; Clinical Research Neurology, Eisai, Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Adam O', 'Initials': 'AO', 'LastName': 'Hebb', 'Affiliation': 'Department of Neurological Surgery, Kaiser Permanente, Denver, CO, USA.'}, {'ForeName': 'Sierra M', 'Initials': 'SM', 'LastName': 'Farris', 'Affiliation': 'Division of Neuromodulation, Boston Scientific, Valencia, CA, USA; Movement and Neuroperformance Center of Colorado, Englewood, CO, USA.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Whiting', 'Affiliation': 'Department of Neurosurgery, Allegheny General Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Leichliter', 'Affiliation': 'Department of Neurology, Allegheny General Hospital, Pittsburgh, PA, USA.'}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Ostrem', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'San Luciano', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Galifianakis', 'Affiliation': 'Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Verhagen Metman', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Sepehr', 'Initials': 'S', 'LastName': 'Sani', 'Affiliation': 'Department of Neurological Surgery, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Karl', 'Affiliation': 'Department of Neurological Sciences, Rush University Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Mustafa S', 'Initials': 'MS', 'LastName': 'Siddiqui', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Tatter', 'Affiliation': 'Department of Neurosurgery, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Ihtsham', 'Initials': 'I', 'LastName': 'Ul Haq', 'Affiliation': 'Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Andre G', 'Initials': 'AG', 'LastName': 'Machado', 'Affiliation': 'Center for Neurological Restoration, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Gostkowski', 'Affiliation': 'Center for Neurological Restoration, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tagliati', 'Affiliation': 'Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Adam N', 'Initials': 'AN', 'LastName': 'Mamelak', 'Affiliation': 'Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Okun', 'Affiliation': 'Department of Neurology, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Kelly D', 'Initials': 'KD', 'LastName': 'Foote', 'Affiliation': 'Department of Neurosurgery, College of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Moguel-Cobos', 'Affiliation': 'Department of Neurology, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Francisco A', 'Initials': 'FA', 'LastName': 'Ponce', 'Affiliation': 'Department of Neurosurgery, Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Pahwa', 'Affiliation': 'Department of Neurology, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Jules M', 'Initials': 'JM', 'LastName': 'Nazzaro', 'Affiliation': 'Department of Neurosurgery, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Cathrin M', 'Initials': 'CM', 'LastName': 'Buetefisch', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Gross', 'Affiliation': 'Department of Neurosurgery, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Corneliu C', 'Initials': 'CC', 'LastName': 'Luca', 'Affiliation': 'Department of Neurology, University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Jonathan R', 'Initials': 'JR', 'LastName': 'Jagid', 'Affiliation': 'Department of Neurosurgery, University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Gonzalo J', 'Initials': 'GJ', 'LastName': 'Revuelta', 'Affiliation': 'Department of Neurology, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Takacs', 'Affiliation': 'Department of Neurosurgery, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Pourfar', 'Affiliation': 'Department of Neurology, New York University Medical Center, New York City, NY, USA.'}, {'ForeName': 'Alon Y', 'Initials': 'AY', 'LastName': 'Mogilner', 'Affiliation': 'Department of Neurosurgery, New York University Medical Center, New York City, NY, USA.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Duker', 'Affiliation': 'Department of Neurology, University of Cincinnati Medical Center, Cincinnati, OH, USA.'}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': 'Mandybur', 'Affiliation': 'Department of Neurosurgery, University of Cincinnati Medical Center, Cincinnati, OH, USA.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Rosenow', 'Affiliation': 'Department of Neurosurgery, Northwestern University School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Cooper', 'Affiliation': 'Department of Neurology, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Park', 'Affiliation': 'Department of Neurosurgery, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Suketu M', 'Initials': 'SM', 'LastName': 'Khandhar', 'Affiliation': 'Department of Neurology, Kaiser Permanente Medical Center, Sacramento, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sedrak', 'Affiliation': 'Department of Neurosurgery, Kaiser Permanente Medical Center, Redwood City, CA, USA.'}, {'ForeName': 'Fenna T', 'Initials': 'FT', 'LastName': 'Phibbs', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Julie G', 'Initials': 'JG', 'LastName': 'Pilitsis', 'Affiliation': 'Department of Neurosurgery, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Uitti', 'Affiliation': 'Department of Neurology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Starr', 'Affiliation': 'Department of Neurosurgery, University of California, San Francisco, San Francisco, CA, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30108-3']
1397,32484068,Effects of Neurocognitive Temporal Training on Weapon Firing Performance.,"While marksmanship is a critical skill for military personnel, some service members experience difficulty in attaining and maintaining marksmanship qualifications. Temporal training may improve marksmanship performance, since rhythm and timing are critical for coordinated movement. In this study, we examined the effect of neurocognitive temporal training (NTT) on military personnel's marksmanship performance. We randomly assigned 41 active duty U.S. Army service members with prior marksmanship training into an NTT group that received 12 NTT training sessions ( N  = 18) and a Control group ( N  = 23) that received no NTT training. We measured marksmanship at baseline (pretest) and following either NTT (posttest) or, for the Control group, a comparable time period. We quantified marksmanship during 2 tasks of firing 5 self-paced shots at stationary 175 m and 300 m targets (Task 1) and firing at 50 moving and stationary targets of varying distances (Task 2). We recorded three measures of accuracy and three measures of precision (including Total Path Length, a unique measure quantifying shot-to-shot variability) for the first task, and we recorded one accuracy measure for the second task. To determine group differences for pretest versus posttest, we used multivariate analysis of variances for Task 1 and a mixed-model analysis of variance for Task 2. Results revealed significantly reduced variability and improved precision when firing at the 175 m target for the NTT group compared with the Control group ( p  < .05), but there were no significant group differences on other measures. While these results suggest the utility of neurocognitive timing and rhythm training for marksmanship precision, additional research is needed and should include varied training regimens, comparisons of expert versus novice shooters, additional outcome measures, and a larger participant sample.",2020,"Results revealed significantly reduced variability and improved precision when firing at the 175 m target for the NTT group compared with the Control group ( p  < .05), but there were no significant group differences on other measures.","[""military personnel's marksmanship performance"", '41 active duty U.S. Army service members with prior']","['marksmanship training into an NTT group that received 12 NTT training sessions ( N \u2009=\u200918) and a Control group ( N \u2009=\u200923) that received no NTT training', 'Temporal training', 'neurocognitive temporal training (NTT', 'Neurocognitive Temporal Training']","['Weapon Firing Performance', 'variability and improved precision', 'precision (including Total Path Length, a unique measure quantifying shot-to-shot variability']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0336663', 'cui_str': 'Instrument of aggression'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",41.0,0.0252952,"Results revealed significantly reduced variability and improved precision when firing at the 175 m target for the NTT group compared with the Control group ( p  < .05), but there were no significant group differences on other measures.","[{'ForeName': 'Leah R', 'Initials': 'LR', 'LastName': 'Enders', 'Affiliation': 'DCS Corporation, Alexandria, Virginia, United States.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Boykin', 'Affiliation': 'Army Research Laboratory, San Antonio, Texas, United States.'}, {'ForeName': 'Valerie J', 'Initials': 'VJ', 'LastName': 'Rice', 'Affiliation': 'Army Research Laboratory, San Antonio, Texas, United States.'}]",Perceptual and motor skills,['10.1177/0031512520927508']
1398,32583295,Evaluating the Incidence of Opioid-Induced Respiratory Depression Associated with Oliceridine and Morphine as Measured by the Frequency and Average Cumulative Duration of Dosing Interruption in Patients Treated for Acute Postoperative Pain.,"BACKGROUND AND OBJECTIVE


Opioid-induced respiratory depression (OIRD) is a potentially fatal complication associated with conventional opioids. Currently, there is a paucity of validated endpoints available to measure respiratory safety. Oliceridine, an investigational intravenous (IV) opioid, is a G-protein selective μ-agonist with limited activity on β-arrestin2, a signaling pathway associated with adverse events including OIRD. In controlled phase III trials, oliceridine 0.35 mg and 0.5 mg demand doses demonstrated comparable analgesia to morphine 1 mg with favorable improvements in respiratory safety. In this exploratory analysis, we report dosing interruption (DI) and average cumulative duration of DI (CDDI) for both oliceridine and morphine.
METHODS


Patients requiring analgesia after bunionectomy or abdominoplasty were randomized to IV demand doses of placebo, oliceridine (0.1 mg, 0.35 mg, or 0.5 mg), or morphine (1 mg), administered via patient-controlled analgesia (PCA), following a loading dose (oliceridine 1.5 mg, morphine 4 mg, volume-matched placebo) with a 6-min lockout interval. Certified nurse anesthetists monitored each patient and withheld study medication according to the patient's respiratory status. For each patient, the duration of all DIs was summed and reported as CDDI. A zero-inflated gamma mixture model was used to compute the mean CDDI for each treatment.
RESULTS


Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%). The CDDI was also lower across all demand doses of oliceridine versus morphine.
CONCLUSION


Using DI as a surrogate for OIRD indicates improved respiratory safety with oliceridine versus morphine that merits further investigation.",2020,"RESULTS


Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%).","['Patients requiring analgesia after bunionectomy or abdominoplasty', 'Patients Treated for Acute Postoperative Pain']","['Oliceridine and Morphine', 'oliceridine', 'placebo, oliceridine', 'morphine (1\xa0mg), administered via patient-controlled analgesia (PCA), following a loading dose (oliceridine 1.5\xa0mg, morphine 4\xa0mg, volume-matched placebo', 'oliceridine and morphine', 'Oliceridine', 'morphine']","['respiratory safety', 'average cumulative duration of DI (CDDI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1542057', 'cui_str': 'Silver bunionectomy'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C2215257', 'cui_str': 'Acute postoperative pain'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",,0.0289906,"RESULTS


Proportion of patients with DI was lower with oliceridine (0.1 mg: 3.2%, 0.35 mg: 13.9%, 0.5 mg: 15.1%) versus morphine (22%).","[{'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Ayad', 'Affiliation': 'Department of Anesthesiology, Cleveland Clinic, Outcomes Research, Anesthesiology Institute, Fairview Hospital, 18101 Lorain Avenue, Cleveland, OH, 44111, USA. Saayad@ccf.org.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Demitrack', 'Affiliation': 'Clinical Operations and Medical Affairs, Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Burt', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Michalsky', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wase', 'Affiliation': 'Clinical Operations and Medical Affairs, Trevena Inc., Chesterbrook, PA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Fossler', 'Affiliation': 'Clinical Development and Quantitative Sciences, Trevena Inc., Chesterbrook, PA, 19087, USA.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Department of Anesthesiology, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}]",Clinical drug investigation,['10.1007/s40261-020-00936-0']
1399,32585354,The benefits and costs of changing treatment technique in electroconvulsive therapy due to insufficient improvement of a major depressive episode.,"BACKGROUND


Electroconvulsive therapy (ECT) technique is often changed after insufficient improvement, yet there has been little research on switching strategies.
OBJECTIVE


To document clinical outcome in ECT nonresponders who were received a second course using high dose, brief pulse, bifrontotemporal (HD BP BL) ECT, and compare relapse rates and cognitive effects relative to patients who received only one ECT course and as a function of the type of ECT first received.
METHODS


Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University. Nonresponders received HD BP BL ECT. In a separate multi-site trial, Optimization of ECT, patients were randomized to right unilateral or BL ECT and nonresponders also received further treatment with HD BP BL ECT.
RESULTS


Remission rates with a second course of HD BP BL ECT were high in ECT nonresponders, approximately 60% and 40% in the Columbia University and Optimization of ECT studies, respectively. Clinical outcome was independent of the type of ECT first received. A second course with HD BP BL ECT resulted in greater retrograde amnesia immediately, two months, and six months following ECT.
CONCLUSIONS


In the largest samples of ECT nonresponders studied to date, a second course of ECT had marked antidepressant effects. Since the therapeutic effects were independent of the technique first administered, it is possible that many patients may benefit simply from longer courses of ECT. Randomized trials are needed to determine whether, when, and how to change treatment technique in ECT.",2020,Clinical outcome was independent of the type of ECT first received.,"['Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University', 'patients who received only one ECT course and as a function of the type of ECT first received']","['Electroconvulsive therapy (ECT) technique', 'right unilateral or BL ECT', 'Electroconvulsive Therapy', 'HD BP BL ECT']","['retrograde amnesia', 'HD BP BL ECT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0002624', 'cui_str': 'Retrograde amnesia'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]",,0.0665526,Clinical outcome was independent of the type of ECT first received.,"[{'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; Department of Radiology, Columbia University, NY, USA. Electronic address: has1@columbia.edu.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Prudic', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; New York State Psychiatric Institute, NY, USA.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Devanand', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; New York State Psychiatric Institute, NY, USA; Department of Neurology, Columbia University, NY, USA.'}, {'ForeName': 'Mitchell S', 'Initials': 'MS', 'LastName': 'Nobler', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, New York Medical College, NY, USA.'}, {'ForeName': 'Roger F', 'Initials': 'RF', 'LastName': 'Haskett', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.016']
1400,32584909,Machine learning insight into the role of imaging and clinical variables for the prediction of obstructive coronary artery disease and revascularization: An exploratory analysis of the CONSERVE study.,"BACKGROUND


Machine learning (ML) is able to extract patterns and develop algorithms to construct data-driven models. We use ML models to gain insight into the relative importance of variables to predict obstructive coronary artery disease (CAD) using the Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization (CONSERVE) study, as well as to compare prediction of obstructive CAD to the CAD consortium clinical score (CAD2). We further perform ML analysis to gain insight into the role of imaging and clinical variables for revascularization.
METHODS


For prediction of obstructive CAD, the entire ICA arm of the study, comprising 719 patients was used. For revascularization, 1,028 patients were randomized to invasive coronary angiography (ICA) or coronary computed tomographic angiography (CCTA). Data was randomly split into 80% training 20% test sets for building and validation. Models used extreme gradient boosting (XGBoost).
RESULTS


Mean age was 60.6 ± 11.5 years and 64.3% were female. For the prediction of obstructive CAD, the AUC was significantly higher for ML at 0.779 (95% CI: 0.672-0.886) than for CAD2 (0.696 [95% CI: 0.594-0.798]) (P = 0.01). BMI, age, and angina severity were the most important variables. For revascularization, the model obtained an overall area under the receiver-operation curve (AUC) of 0.958 (95% CI = 0.933-0.983). Performance did not differ whether the imaging parameters used were from ICA (AUC 0.947, 95% CI = 0.903-0.990) or CCTA (AUC 0.941, 95% CI = 0.895-0.988) (P = 0.90). The ML model obtained sensitivity and specificity of 89.2% and 92.9%, respectively. Number of vessels with ≥70% stenosis, maximum segment stenosis severity (SSS) and body mass index (BMI) were the most important variables. Exclusion of imaging variables resulted in performance deterioration, with an AUC of 0.705 (95% CI 0.614-0.795) (P <0.0001).
CONCLUSIONS


For obstructive CAD, the ML model outperformed CAD2. BMI is an important variable, although currently not included in most scores. In this ML model, imaging variables were most associated with revascularization. Imaging modality did not influence model performance. Removal of imaging variables reduced model performance.",2020,"For the prediction of obstructive CAD, the AUC was significantly higher for ML at 0.779 (95% CI: 0.672-0.886) than for CAD2 (0.696 [95% CI: 0.594-0.798])","['1,028 patients were randomized to', 'Mean age was 60.6 ± 11.5 years and 64.3% were female', 'obstructive coronary artery disease and revascularization', '719 patients was used']","['Machine learning (ML', 'invasive coronary angiography (ICA) or coronary computed tomographic angiography (CCTA', 'Coronary Computed Tomographic Angiography']","['Performance', 'BMI', 'Number of vessels with ≥70% stenosis, maximum segment stenosis severity (SSS) and body mass index (BMI', 'BMI, age, and angina severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}]",1028.0,0.0893556,"For the prediction of obstructive CAD, the AUC was significantly higher for ML at 0.779 (95% CI: 0.672-0.886) than for CAD2 (0.696 [95% CI: 0.594-0.798])","[{'ForeName': 'Lohendran', 'Initials': 'L', 'LastName': 'Baskaran', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Ying', 'Affiliation': 'Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Zhuoran', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Subhi J', 'Initials': 'SJ', 'LastName': ""Al'Aref"", 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Sang-Eun', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Integrative Cardiovascular Imaging Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Danad', 'Affiliation': 'VU Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hyung-Bok', 'Initials': 'HB', 'LastName': 'Park', 'Affiliation': 'Myongji Hospital, Seonam University College of Medicine, Gyeonggi-do, South Korea.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Bathina', 'Affiliation': 'CARE Hospital and FACTS Foundation, Hyderabad, India.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baggiano', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Beltrama', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Cerci', 'Affiliation': 'Quanta Diagnostico Nuclear, Curitiba, Brazil.'}, {'ForeName': 'Eui-Young', 'Initials': 'EY', 'LastName': 'Choi', 'Affiliation': 'Gangnam Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Jung-Hyun', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Pusan National University Hospital, Busan, South Korea.'}, {'ForeName': 'So-Yeon', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Ajou University Hospital, Gyeonggi-do, South Korea.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Cole', 'Affiliation': 'Cardiology Associates of Mobile, Mobile, Alabama, United States of America.'}, {'ForeName': 'Joon-Hyung', 'Initials': 'JH', 'LastName': 'Doh', 'Affiliation': 'Inje University, Ilsan Paik Hospital, Gyeonggi-do, South Korea.'}, {'ForeName': 'Sang-Jin', 'Initials': 'SJ', 'LastName': 'Ha', 'Affiliation': 'Gangneung Asan Hospital, Gangwon-do, South Korea.'}, {'ForeName': 'Ae-Young', 'Initials': 'AY', 'LastName': 'Her', 'Affiliation': 'Kangwon National University Hospital, Gangwon-do, South Korea.'}, {'ForeName': 'Cezary', 'Initials': 'C', 'LastName': 'Kepka', 'Affiliation': 'Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Jang-Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Wonju Severance Hospital, Gangwon-do, South Korea.'}, {'ForeName': 'Jin-Won', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Korea University Guro Hospital, Seoul, South Korea.'}, {'ForeName': 'Sang-Wook', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Chung-Ang University Hospital, Seoul, South Korea.'}, {'ForeName': 'Woong', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Yeungnam University Hospital, Daegu, South Korea.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Heo', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Ji-Min', 'Initials': 'JM', 'LastName': 'Sung', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Valeti', 'Affiliation': 'Department of Medicine, Stanford Medicine, Stanford, California, United States of America.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Andreini', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pontone', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Donghee', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Department of Imaging, Cedars-Sinai Medical Center, Cedars-Sinai Heart Institute, Los Angeles, California, United States of America.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Villines', 'Affiliation': 'Department of Medicine, University of Virginia Health System, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Fay', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Hyuk-Jae', 'Initials': 'HJ', 'LastName': 'Chang', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Integrative Cardiovascular Imaging Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Min', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Leslee J', 'Initials': 'LJ', 'LastName': 'Shaw', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}]",PloS one,['10.1371/journal.pone.0233791']
1401,32592693,Physical examination-indicated cerclage in twin pregnancy: a randomized controlled trial.,"BACKGROUND


Women with twin pregnancies and a dilated cervix in the second trimester are at increased risk of pregnancy loss and early preterm birth; there is currently no proven therapy to prevent preterm birth in this group of women.
OBJECTIVE


This study aimed to determine whether physical examination-indicated cerclage reduces the incidence of preterm birth in women with a diagnosis of twin pregnancies and asymptomatic cervical dilation before 24 weeks of gestation.
STUDY DESIGN


Multicenter, parallel group, open-label, randomized controlled trial of women with twin pregnancies and asymptomatic cervical dilation of 1 to 5 cm between 16 weeks 0/7 days of gestation and 23 weeks 6/7 days of gestation were enrolled from July 2015 to July 2019 in 8 centers. Eligible women were randomized in a 1:1 ratio into either cerclage or no cerclage groups. We excluded women with monochorionic-monoamniotic twin pregnancy, selective fetal growth restriction, twin-twin transfusion syndrome, major fetal malformation, known genetic anomaly, placenta previa, signs of labor, or clinical chorioamnionitis. The primary outcome was the incidence of preterm birth at <34 weeks of gestation. Secondary outcomes were preterm births at <32, <28, and <24 weeks of gestation, interval from diagnosis to delivery, and perinatal mortality. Data were analyzed by intention-to-treat methods.
RESULTS


After an interim analysis was performed, the Data and Safety Monitoring Board recommended stopping the trial because of a significant decrease in perinatal mortality in the cerclage group. We randomized 34 women, with 4 women being excluded because of expired informed consent. A total of 17 women were randomized to physical examination-indicated cerclage and 13 women to no cerclage. Whereas 4 women randomized to cerclage did not receive the surgical procedure, no women in the no cerclage group received cerclage. Maternal demographics were not significantly different. All women in the cerclage group also received indomethacin and antibiotics. When comparing the cerclage group vs the no cerclage group, the incidence of preterm birth was significantly decreased as follows: preterm birth at <34 weeks of gestation, 12 of 17 women (70%) vs 13 of 13 women (100%) (risk ratio, 0.71; 95% confidence interval, 0.52-0.96); preterm birth at <32 weeks of gestation, 11 of 17 women (64.7%) vs 13 of 13 women (100%) (risk ratio, 0.65; 95% confidence interval, 0.46-0.92); preterm birth at <28 weeks of gestation, 7 of 17 women (41%) vs 11 of 13 women (84%) (risk ratio, 0.49; 95% confidence interval, 0.26-0.89); and preterm birth at <24 weeks of gestation, 5 of 17 women (30%) vs 11 of 13 women (84%) (risk ratio, 0.35; 95% confidence interval, 0.16-0.75). The mean gestational age at delivery was 29.05±1.7 vs 22.5±3.9 weeks (P<.01), respectively; the mean interval from diagnosis of cervical dilation to delivery was 8.3±5.8 vs 2.9±3.0 weeks (P=.02), respectively. Perinatal mortality was also significantly reduced in the cerclage group compared with the no cerclage group as follows: 6 of 34 women (17.6%) vs 20 of 26 women (77%) (risk ratio, 0.22; 95% confidence interval, 0.1-0.5), respectively.
CONCLUSION


In women with twin pregnancies and asymptomatic cervical dilation before 24 weeks of gestation, a combination of physical examination-indicated cerclage, indomethacin, and antibiotics significantly decreased preterm birth at all evaluated gestational ages. Most importantly, cerclage in this population was associated with a 50% decrease in early preterm birth at <28 weeks of gestation and with a 78% decrease in perinatal mortality.",2020,"When comparing cerclage vs no cerclage group, the incidence of preterm birth <34 weeks was significantly decreased: 12/17 (70%) vs 13/13 (100%) (RR: 0.71 95% CI 0.52-0.96), as well as preterm birth <32 weeks 11/17 (64.7%) vs 13/13 (100%) (RR: 0.65 95% CI 0.46-0.92), preterm birth <28 weeks 7/17 (41%) vs 11/13 (84%) (RR: 0.49 95% CI 0.26-0.89) and preterm birth <24 weeks 5/17 (30%) vs 11/13 (84%) (RR: 0.35 95% CI 0.16-0.75).","['women with twin pregnancy, and asymptomatic cervical dilation from 1-5 cm between 16 0/7 to 23 6/7 weeks were enrolled from 7/2015 to 7/2019 in 8 centers', 'Seventeen women', 'women with: monochorionic-monoamniotic pregnancy, selective fetal growth restriction, twin-twin transfusion syndrome, major fetal malformation, known genetic anomaly, placenta previa, signs of labor, or clinical chorioamnionitis', 'Eligible women', 'asymptomatic women with twin gestations and cervical dilation diagnosed before 24 weeks of pregnancy', 'Twin pregnancy', '34 women, four were excluded due to expired informed consent']","['cerclage', 'physical exam indicated cerclage and 13 women to no cerclage', 'cerclage or no cerclage', 'Physical Exam Indicated Cerclage', 'indomethacin and antibiotics', 'physical exam indicated cerclage, indomethacin, and antibiotics', 'physical exam indicated cerclage']","['incidence of preterm birth <34 weeks', 'perinatal mortality', 'incidence of preterm birth', 'mean interval from diagnosis of cervical dilation to delivery', 'preterm birth', 'mean gestational age at delivery', 'Perinatal mortality', 'preterm birth <32, <28 and <24 weeks, interval from diagnosis to delivery, and perinatal mortality', 'Maternal demographics']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C2909036', 'cui_str': 'Twin-to-twin blood transfer'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0032046', 'cui_str': 'Placenta previa'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008495', 'cui_str': 'Chorioamnionitis'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}]","[{'cui': 'C1292825', 'cui_str': 'Cerclage'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0031062', 'cui_str': 'Perinatal Mortality'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",34.0,0.350373,"When comparing cerclage vs no cerclage group, the incidence of preterm birth <34 weeks was significantly decreased: 12/17 (70%) vs 13/13 (100%) (RR: 0.71 95% CI 0.52-0.96), as well as preterm birth <32 weeks 11/17 (64.7%) vs 13/13 (100%) (RR: 0.65 95% CI 0.46-0.92), preterm birth <28 weeks 7/17 (41%) vs 11/13 (84%) (RR: 0.49 95% CI 0.26-0.89) and preterm birth <24 weeks 5/17 (30%) vs 11/13 (84%) (RR: 0.35 95% CI 0.16-0.75).","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Roman', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA. Electronic address: amanda.roman@jefferson.edu.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Zork', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University, New York, NY.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Haeri', 'Affiliation': ""Division of Maternal-Fetal Medicine, Obstetrics and Gynecology Department, St David's Women's Center of Texas, Austin, TX.""}, {'ForeName': 'Corina N', 'Initials': 'CN', 'LastName': 'Schoen', 'Affiliation': 'Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Saccone', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences, and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Colihan', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Albany Medical Center, Albany, NY.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Zelig', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Albany Medical Center, Albany, NY.'}, {'ForeName': 'Alexis C', 'Initials': 'AC', 'LastName': 'Gimovsky', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, the George Washington University School of Medicine and Health Sciences, Washington, DC.'}, {'ForeName': 'Neil S', 'Initials': 'NS', 'LastName': 'Seligman', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Rochester Medical Center, Rochester, NY.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Zullo', 'Affiliation': 'Department of Neuroscience, Reproductive Sciences, and Dentistry, School of Medicine, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Berghella', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.06.047']
1402,32593895,Effect of administration of β-hydroxy-β-methyl butyrate-enriched formula after liver transplantation: A pilot randomized controlled trial.,"OBJECTIVE


Most patients undergoing liver transplantation (LT) have decreased skeletal muscle mass, malnutrition, and decreased physical activity levels. These comorbidities may prevent early recovery after surgery. The aim of this study was to examine the effects of oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite that promotes muscle synthesis and suppresses proteolysis, on postoperative sarcopenia and other outcomes after adult-to-adult living donor LT (LDLT).
METHODS


Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria were randomly assigned in a 1:1 ratio to the HMB or control group. Patients in the HMB group received two packs of HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine (7000 mg) per pack orally or enterally from postoperative day 1 to 30 with postoperative rehabilitation. The primary endpoint was grip strength (GS) at 2 mo after LDLT. Secondary endpoints included GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS).
RESULTS


Twelve patients in the HMB group and 11 in the control group were included in the final analysis. GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04). In the HMB group, white blood cell count 3 wk after LDLT was significantly lower (P = 0.005), and postoperative hospital LOS was significantly shorter (P = 0.028) compared with the control group. The incidence of postoperative bacteremia was lower in the HMB group.
CONCLUSIONS


Postoperative administration of HMB-enriched formula with rehabilitation significantly increased GS at 1 and 2 mo and SMI at 2 mo and shortened postoperative hospital LOS after LDLT.",2020,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","['patients undergoing liver transplantation (LT', 'after liver transplantation', 'adult-to-adult living donor LT (LDLT', 'Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria', 'Twelve patients in the HMB group and 11 in the control group were included in the final analysis']","['HMB', 'oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite', 'HMB or control group', 'HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine', 'β-hydroxy-β-methyl butyrate-enriched formula']","['SMI values', 'grip strength (GS', 'white blood cell count', 'incidence of postoperative bacteremia', 'postoperative hospital LOS', 'GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS', 'GS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]","[{'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",33.0,0.0731392,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","[{'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kamo', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Kaido', 'Affiliation': ""Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Department of Gastroenterological and General Surgery, St Luke's International University and Hospital, Tokyo, Japan. Electronic address: kaido@kuhp.kyoto-u.ac.jp.""}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Uozumi', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Yagi', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Hata', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Taura', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Uemoto', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110871']
1403,32593936,Endometrial scratch injury with office hysteroscopy before IVF/ICSI: A randomised controlled trial.,"OBJECTIVE


Endometrial scratch injury (ESI) has been proposed to improve endometrial receptivity and thereby increase implantation rates in assisted reproductive technology (ART) treatment. ESI has been widely incorporated into clinical practice despite inconclusive evidence of its effect on reproductive outcomes. We aimed to assess pregnancy and live birth rates in subfertile women receiving ESI before IVF treatment in comparison to controls.
STUDY DESIGN


This was a randomised controlled trial (RCT) with no blinding of participants, investigators or health care personnel. Women in ART treatment were allocated to either office hysteroscopy with ESI (ESI group) or no intervention (control group). In total 184 women in IVF/ICSI treatment with minimum one previous failed IVF/ICSI cycle, were included in the final analysis. The primary outcome was positive serum hCG (s-hCG). Secondary outcomes were ongoing pregnancy and live birth rate. Only per-protocol analyses were performed as all patients included at one centre had to be excluded. The trial is registered at ClinicalTrials.gov, NCT01743391.
RESULTS


Our results showed a non-significant increase in positive s-hCG (OR 1.23, 95 % CI (0.65-2.33)), ongoing pregnancy (OR 1.52, 95 % CI (0.73-3.17)), and live birth rates (OR 1.69, 95 % CI (0.78-3.64)) per randomised woman between the ESI and the control group.
CONCLUSION


We observed no significant differences in positive s-hCG or other reproductive outcomes in the ESI vs. the control group. While the crude estimates of positive reproductive outcomes were higher in the ESI group, statistical significance was not reached, and the study was not powered to show smaller differences. However, data from this study will be re-evaluated in the context of an individual participant data meta-analysis (IPD-MA) of RCTs on ESI.",2020,Women in ART treatment were allocated to either office hysteroscopy with ESI (ESI group) or no intervention (control group).,"['In total 184 women in IVF/ICSI treatment with minimum one previous failed IVF/ICSI cycle, were included in the final analysis', 'Endometrial scratch injury with office hysteroscopy before IVF/ICSI', 'subfertile women receiving ESI before IVF treatment in comparison to controls', 'Women in ART treatment', 'participants, investigators or health care personnel']","['office hysteroscopy with ESI (ESI group) or no intervention (control group', 'ESI']","['positive reproductive outcomes', 'live birth rates', 'ongoing pregnancy and live birth rate', 'ongoing pregnancy', 'positive s-hCG', 'pregnancy and live birth rates', 'positive serum hCG (s-hCG']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035157', 'cui_str': 'Reproductive Technologies'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}]",184.0,0.498981,Women in ART treatment were allocated to either office hysteroscopy with ESI (ESI group) or no intervention (control group).,"[{'ForeName': 'Sine', 'Initials': 'S', 'LastName': 'Berntsen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark; The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark. Electronic address: sine.berntsen.01@regionh.dk.'}, {'ForeName': 'Kristine Juul', 'Initials': 'KJ', 'LastName': 'Hare', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Løssl', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark; The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Bogstad', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark; The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Palmø', 'Affiliation': 'Department of Obstetrics and Gynaecology, Holbaek Hospital, Smedelundsgade 60, 4300 Holbaek, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Prætorius', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zedeler', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark; The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.06.034']
1404,32617960,"Modeling the Effect of DAV132, a Novel Colon-Targeted Adsorbent, on Fecal Concentrations of Moxifloxacin and Gut Microbiota Diversity in Healthy Volunteers.","To prevent antibiotic-induced perturbations on gut microbiota, DAV132, a novel colon-targeted adsorbent, which sequesters antibiotic residues in the lower gastrointestinal tract, was developed. We built an integrated pharmacological model of how DAV132 reduces fecal free moxifloxacin and preserves gut microbiota. We used plasma and fecal free moxifloxacin concentrations, and Shannon diversity index from 16S ribosomal RNA gene metagenomics analysis of fecal microbiota, of 143 healthy volunteers assigned randomly to receive moxifloxacin only, or with 10 DAV132 dose regimens, or to a control group. We modeled reduced fecal moxifloxacin concentrations using a transit model for DAV132 kinetics and a Michaelis-Menten model with an effect of the amount of activated charcoal on adsorption efficacy. Changes in moxifloxacin-induced perturbations on gut microbiota diversity were then quantified through a turnover model with the Emax model. With the developed model, the efficiency of pharmacokinetic antagonism and its consequences on gut microbiota diversity were quantified.",2020,We built an integrated pharmacological model of how DAV132 reduces fecal free moxifloxacin (MXF) and preserves gut microbiota.,"['healthy volunteers', '143 healthy volunteers assigned randomly to receive']","['DAV132', 'moxifloxacin (MXF', 'moxifloxacin', 'MXF']","['fecal MXF concentrations', 'gut microbiota diversity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",143.0,0.0162659,We built an integrated pharmacological model of how DAV132 reduces fecal free moxifloxacin (MXF) and preserves gut microbiota.,"[{'ForeName': 'Jinju', 'Initials': 'J', 'LastName': 'Guk', 'Affiliation': 'Université de Paris, IAME, INSERM, Paris, France.'}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Guedj', 'Affiliation': 'Université de Paris, IAME, INSERM, Paris, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Burdet', 'Affiliation': 'Université de Paris, IAME, INSERM, Paris, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Andremont', 'Affiliation': 'Université de Paris, IAME, INSERM, Paris, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'de Gunzburg', 'Affiliation': 'Da Volterra, Paris, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Ducher', 'Affiliation': 'Da Volterra, Paris, France.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Mentré', 'Affiliation': 'Université de Paris, IAME, INSERM, Paris, France.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1977']
1405,32619848,The influence of placebo administration on the first- night effect in patients with insomnia disorder.,"OBJECTIVE


We aimed to investigate the effects of placebo on the first-night effect (FNE) in insomniacs.
METHODS


In sum, 36 patients with insomnia disorder who met the DSM-5 criteria were enrolled in this study. Sixteen patients with insomnia disorder were given two days of placebo intervention (placebo-administration group, PL). Twenty patients with insomnia disorder (drug-free group, DF) were not given any interventions. All participants underwent two consecutive nights of polysomnographic (PSG) testing in the sleep laboratory. Sleep diaries were recorded during one week at home before the PSG nights and on two subsequent nights.
RESULTS


The results demonstrated that compared with the DF group, sleep onset latency (SOL), time in bed (TIB) and wake after sleep onset (WASO) significantly increased and sleep efficiency (SE) significantly decreased in the first sleep lab night in the PL group (all p < 0.05). Moreover, compared with the second night, significant differences were observed in lower self-reported total sleep time (TST) and more subjective WASO during the first night in the PL group (all p < 0.05). However, no significant difference was found in the duration and percentage of N1, N2, N3 and REM between the two groups.
CONCLUSION


In patients with insomnia disorder, placebo administration may increase the occurrence of worse sleep without causing a change in the duration and percentage of N1, N2, N3 and REM on the first sleep lab night. In some cases, a placebo may not serve as treatment but may result in a nocebo effect.",2020,"However, no significant difference was found in the duration and percentage of N1, N2, N3 and REM between the two groups.
","['patients with insomnia disorder', 'Twenty patients with insomnia disorder (drug-free group, DF', 'All participants underwent two consecutive nights of polysomnographic (PSG) testing in the sleep laboratory', '36 patients with insomnia disorder who met the DSM-5 criteria', 'insomniacs', 'Sixteen patients with insomnia disorder']","['placebo intervention (placebo-administration group, PL', 'placebo']","['duration and percentage of N1, N2, N3 and REM', 'Sleep diaries', 'occurrence of worse sleep', 'lower self-reported total sleep time (TST) and more subjective WASO', 'sleep onset latency (SOL), time in bed (TIB) and wake after sleep onset (WASO', 'sleep efficiency (SE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",36.0,0.0242769,"However, no significant difference was found in the duration and percentage of N1, N2, N3 and REM between the two groups.
","[{'ForeName': 'Sifan', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Yuezhen', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Neuropsychiatry, Behavioral Neurology and Sleep Center, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Sijia', 'Initials': 'S', 'LastName': 'Lou', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': 'Sleep Medicine Center, Suzhou Guangji Hospital, The Affiliated Guangji Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yao', 'Affiliation': 'Department of Physiology, College of Basic Medicine, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Sleep Medicine Center, Department of Respiratory and Critical Care Medicine, Translational Neuroscience Center, State Key Laboratory, West China Hospital, Sichuan University, Chengdu, China. Electronic address: 2372564613@qq.com.'}, {'ForeName': 'Hongqiang', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China. Electronic address: sunhq@bjmu.edu.cn.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.002']
1406,32619868,Extended-release naltrexone versus buprenorphine-naloxone to treat opioid use disorder among black adults.,"Few studies examine the effectiveness of treatments for opioid use disorder (OUD) among Black individuals despite recent evidence suggesting opioid overdose death rates are, in some cases, highest and increasing at a faster rate among Black people compared to other racial/ethnic groups. This secondary analysis study investigated treatment preference, retention, and relapse rates amongst a subgroup of 73 Black participants with OUD (81% male, mean age 39.05, SD = 11.80) participating in a 24-week multisite randomized clinical trial (""X:BOT"") comparing the effectiveness of extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX) between 2014 and 2017. Chi-square analyses were used to investigate treatment preference assessed at baseline, and logistic regression analyses were used to investigate differences in the odds of retention and relapse assessed over the 24-week course of treatment between treatment groups. Our findings suggest no differences in preference for XR-NTX versus BUP-NX. However, similar to the parent trial, there was an induction hurdle such that only 59.5% of those randomized to XR-NTX successfully initiated medication compared to 91.6% of those randomized to BUP-NX (OR = 0.13, 95% CI = 0.04, 0.52). No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol [i.e., those who initiated medication]: OR = 0.60, 95% CI = 0.20, 1.82) or relapse rates between treatment groups (intention-to-treat: OR = 1.53, 95% CI = 0.57, 4.13; per-protocol: OR = 0.69, 95% CI = 0.23, 2.06). Although there is a significant initiation hurdle with XR-NTX, once inducted, both medications appear similar in effectiveness, but as in the main study, dropout rates were high. Future research is needed on how to improve adherence.",2020,"No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol","['black adults', '73 Black participants with OUD (81% male, mean age 39.05, SD\xa0=\xa011.80) participating']","['extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX', 'naltrexone', 'buprenorphine-naloxone']",['relapse rates'],"[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",73.0,0.101327,"No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol","[{'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Haeny', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 34 Park St., New Haven, CT 06511, United States. Electronic address: angela.haeny@yale.edu.'}, {'ForeName': 'LaTrice', 'Initials': 'L', 'LastName': 'Montgomery', 'Affiliation': 'University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience, 3131 Harvey Avenue., Cincinnati, OH 45229, United States.'}, {'ForeName': 'A Kathleen', 'Initials': 'AK', 'LastName': 'Burlew', 'Affiliation': 'University of Cincinnati, Department of Psychology, 2600 Clifton Ave., Cincinnati, OH 45221, United States.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University Grossman School of Medicine, One Park Ave., New York, NY 10016, United States.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Nunes', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106514']
1407,32627975,Effect of Chin-down-plus-larynx-tightening maneuver on swallowing function after minimally invasive esophagectomy: A randomized controlled trail.,"BACKGROUND


The incidence of swallowing abnormality was high after minimally invasive esophagectomy (MIE) for esophageal cancer (EC). Few reports, however, focused on interventions for dysphagia after esophagectomy.
AIM


The purpose of this research was to estimate the effect of Chin-down-plus-larynx-tightening maneuver on swallowing function for patients receiving esophagectomy.
METHOD


This was a 2-arm, parallel-group, single-blind randomized clinical trial, performed in patients suffered from EC from November 2018 to January 2020. Patients were randomly assigned to the intervention group (IG) or the control group (CG). The participants in CG received routine care, and the IG received Chin-down-plus-larynx-tightening maneuver during feeding. The incidence of choking cough, swallowing function, and dietary outcomes were evaluated before and after intervention for 7 days.
RESULTS


A total of 237 EC cases were enrolled and randomized to the IG (n = 118) or CG (n = 119). There was no significant difference between the two groups in terms of demographic and clinical characteristics. Postoperative choking cough occurred in 5 of 118 cases (4.24%) in IG and 18 of 119 cases (19.4%) in CG, the differences showed statistically significant (P < .001). The analysis showed that the participants in the IG compared with the CG have more total caloric intake of 24 hours and higher K/R (the ratio of calories oral achieved to total calories required of body) significantly from D1 to D7 of intervention (P < .05).
CONCLUSION


The findings suggest that the Chin-down-plus-larynx-tightening maneuver can improve swallowing function recovery and oral total food intake and calories in EC patients undergoing MIE.",2020,"Postoperative choking cough occurred in 5 of 118 cases (4.24%) in IG and 18 of 119 cases (19.4%) in CG, the differences showed statistically significant (P ","['patients receiving esophagectomy', 'A total of 237 EC cases', 'EC patients undergoing MIE', 'patients suffered from EC from November 2018 to January 2020', 'after minimally invasive esophagectomy']","['Chin-down-plus-larynx-tightening maneuver during feeding', 'Chin-down-plus-larynx-tightening maneuver', 'minimally invasive esophagectomy (MIE', 'CG', 'intervention group (IG) or the control group (CG']","['incidence of choking cough, swallowing function, and dietary outcomes', 'swallowing function', 'total caloric intake', 'Postoperative choking cough', 'swallowing function recovery and oral total food intake and calories']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0008114', 'cui_str': 'Chin structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0008301', 'cui_str': 'Choking'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0439259', 'cui_str': 'kcal'}]",237.0,0.0724695,"Postoperative choking cough occurred in 5 of 118 cases (4.24%) in IG and 18 of 119 cases (19.4%) in CG, the differences showed statistically significant (P ","[{'ForeName': 'Funa', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': 'Nursing Department, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Qiyun', 'Initials': 'Q', 'LastName': 'Zou', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Peinan', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xianben', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Nursing Department, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}]",Cancer medicine,['10.1002/cam4.3280']
1408,32622871,Treatment of postmenopausal osteoporosis with bone-forming and antiresorptive treatments: Combined and sequential approaches.,"Efficient therapies are available for the treatment of osteoporosis. Bisphosphonates and denosumab are the most commonly used antiresorptive therapies. Despite differences in the increase in bone mineral density seen with these drugs, the reductions in fracture risk are similar; 50-70%, 20%, and 40% for vertebral, non-vertebral and hip fractures, respectively. The bone-forming treatments; teriparatide and abaloparatide increase bone mineral density more than the antiresorptives and the reductions in fracture risk are 85% and 40-50% for vertebral and non-vertebral fractures, respectively, compared to placebo. The VERO study demonstrated a >50% reduction in vertebral and clinical fractures in women treated with teriparatide compared to risedronate. The dual-action treatment; romosozumab leads to more pronounced increases in BMD than other treatment modalities and reduces the risk of vertebral and clinical fractures by 73% and 36% compared to placebo after 12 months and the sequential treatment regime; romosozumab for 12 months followed by alendronate reduced the risk of vertebral, non-vertebral and hip fractures by 48%, 20% and 38%, respectively compared to alendronate after 2-3 years. The evidence for combination therapy targeting both resorption and formation is limited as only short-term studies with BMD as the endpoint have been performed. All bone-forming and dual-action treatments increase BMD and reduce the fracture risk, however, the effect wears off with time and treatment is therefore only temporary and should be followed by antiresorptive treatment with a bisphosphonate or denosumab. The sequence of treatment matters as the BMD response to teriparatide is reduced in patients previously treated with bisphosphonates; however, based on the findings of the VERO trial, the anti-fracture efficacy of bone-forming treatment in comparison with risedronate seems to be preserved after bisphosphonate therapy. The DATA study suggested that transitioning from denosumab to teriparatide is problematic due to the increase in bone resorption occurring after stopping denosumab. Studies have shown further improvements in BMD when transitioning from oral bisphosphonates to zoledronic acid or denosumab. Management of osteoporosis will in many patients include a long-term treatment plan. This will often include sequential therapy which in severe cases preferably should start with bone-forming followed by antiresorptive treatment. The severity of osteoporosis, reaching a treatment goal, and responding to treatment failure are important factors determining the treatment sequence in the individual patient.",2020,"The dual-action treatment; romosozumab leads to more pronounced increases in BMD than other treatment modalities and reduces the risk of vertebral and clinical fractures by 73% and 36% compared to placebo after 12 months and the sequential treatment regime; romosozumab for 12 months followed by alendronate reduced the risk of vertebral, non-vertebral and hip fractures by 48%, 20% and 38%, respectively compared to alendronate after 2-3 years.","['patients previously treated with', 'postmenopausal osteoporosis with bone-forming and antiresorptive treatments']","['teriparatide', 'zoledronic acid or denosumab', 'Bisphosphonates and denosumab', 'bisphosphonates', 'alendronate', 'bisphosphonate or denosumab', 'risedronate', 'placebo']","['bone mineral density', 'vertebral and clinical fractures', 'risk of vertebral, non-vertebral and hip fractures', 'BMD', 'risk of vertebral and clinical fractures', 'fracture risk', 'BMD response', 'bone resorption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C1286272', 'cui_str': 'Form of bone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonate'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}]",,0.0195905,"The dual-action treatment; romosozumab leads to more pronounced increases in BMD than other treatment modalities and reduces the risk of vertebral and clinical fractures by 73% and 36% compared to placebo after 12 months and the sequential treatment regime; romosozumab for 12 months followed by alendronate reduced the risk of vertebral, non-vertebral and hip fractures by 48%, 20% and 38%, respectively compared to alendronate after 2-3 years.","[{'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Langdahl', 'Affiliation': 'Aarhus University Hospital, Endocrinology and Internal Medicine, Palle Juul Jensen Boulevard 115, DK8200 Aarhus N, Denmark. Electronic address: bente.langdahl@aarhus.rm.dk.'}]",Bone,['10.1016/j.bone.2020.115516']
1409,32622904,"Effects of acute inspiratory loading during treadmill running on cerebral, locomotor and respiratory muscle oxygenation in women soccer players.","Respiratory limitation can be a primary mechanism for exercise cessation in female athletes. This study aimed to assess the effects of inspiratory loading (IL) on intercostal muscles (IM), vastus lateralis (VL) and cerebral (Cox) muscles oxygenation in women soccer players during high-intensity dynamic exercise. Ten female soccer players were randomized to perform in order two constant-load tests on a treadmill until the exhaustion time (Tlim) (100 % of maximal oxygen uptake- V˙O 2 ). They breathed freely or against a fixed inspiratory loading (IL) of 41 cm H 2 O (∼30 % of maximal inspiratory pressure). Oxygenated (Δ[OxyHb]), deoxygenated (Δ[DeoxyHb]), total hemoglobin (Δ[tHb]) and tissue saturation index (ΔTSI) were obtained by NIRs. Also, blood lactate [La - ] was obtained. IL significantly reduced Tlim (224 ± 54 vs 78 ± 20; P < 0.05) and increased [La - ], V˙O 2 , respiratory cycles and dyspnea when corrected to Tlim (P < 0.05). IL also resulted in decrease of Δ[OxyHb] of Cox and IM during exercise compared with rest condition. In addition, decrease of Δ[OxyHb] was observed on IM during exercise when contrasted with Sham (P < 0.05). Furthermore, significant higher Δ[DeoxyHb] of IM and significant lower Δ[DeoxyHb] of Cox were observed when IL was applied during exercise in contrast with Sham (P < 0.05). These results were accompanied with significant reduction of Δ[tHb] and ΔTSI of IM and VL when IL was applied (P < 0.05). High-intensity exercise with IL decreased respiratory and peripheral muscle oxygenation with negative impact on exercise performance. However, the increase in ventilatory work did not impact cerebral oxygenation in soccer players.",2020,"IL significantly reduced Tlim (224 ± 54 vs 78 ± 20 sec; P < 0.05) and increased [La-], V̇O 2 , respiratory cycles and dyspnea when corrected to Tlim (P < 0.05).","['women soccer players', 'Ten female soccer players', 'female athletes', 'women soccer players during high-intensity dynamic exercise', 'soccer players']","['acute inspiratory loading during treadmill running', 'Oxygenated (Δ[OxyHb]), deoxygenated (Δ[DeoxyHb', 'High-intensity exercise with IL']","['Δ[OxyHb', 'intercostal (IM), vastus lateralis (VL) and cerebral (Cox) oxygenation', 'total hemoglobin (Δ[tHb]) and tissue saturation index (ΔTSI', 'Δ[DeoxyHb', 'Δ[tHb] and ΔTSI of IM and VL', 'increased [La-], V̇O 2 , respiratory cycles and dyspnea', 'blood lactate [La', 'cerebral, locomotor and respiratory muscle oxygenation', 'exercise performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0592251,"IL significantly reduced Tlim (224 ± 54 vs 78 ± 20 sec; P < 0.05) and increased [La-], V̇O 2 , respiratory cycles and dyspnea when corrected to Tlim (P < 0.05).","[{'ForeName': 'Flavia Rossi', 'Initials': 'FR', 'LastName': 'Caruso', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Archiza', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Daniela Kuguimoto', 'Initials': 'DK', 'LastName': 'Andaku', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Trimer', 'Affiliation': 'Physical Therapy Department, University of Santa Cruz Do Sul - UNISC, Brazil.'}, {'ForeName': 'José Carlos', 'Initials': 'JC', 'LastName': 'Bonjorno-Junior', 'Affiliation': 'Department of Medicine, Federal University of Sao Carlos, Sao Carlos, Brazil.'}, {'ForeName': 'Claudio Ricardo', 'Initials': 'CR', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Medicine, Federal University of Sao Carlos, Sao Carlos, Brazil.'}, {'ForeName': 'Cleiton A', 'Initials': 'CA', 'LastName': 'Libardi', 'Affiliation': 'Laboratory of Neuromuscular Adaptations to Resistance Training, Department of Physical Education, Federal University of São Carlos, Sao Carlos, Brazil.'}, {'ForeName': 'Shane A', 'Initials': 'SA', 'LastName': 'Phillips', 'Affiliation': 'Physical Therapy and Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago, USA.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Arena', 'Affiliation': 'Physical Therapy and Integrative Physiology Laboratory, College of Applied Health Sciences, University of Illinois at Chicago, USA.'}, {'ForeName': 'Renata Gonçalves', 'Initials': 'RG', 'LastName': 'Mendes', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiopulmonary Physiotherapy Laboratory, Federal University of Sao Carlos, Sao Carlos, Sao Paulo, Brazil. Electronic address: audrey@ufscar.br.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103488']
1410,32486864,Robot-Assisted Laparoscopic Partial Nephrectomy  Vs  Conventional Laparoscopic Partial Nephrectomy: Functional and Surgical Outcomes of a Prospective Single Surgeon Randomized Study.,"Background:  Laparoscopic partial nephrectomy (LPN) and robot-assisted partial nephrectomy (RAPN) are commonly used techniques for treating small renal masses. Regarding renal function (RF) preservation, no superiority of one technique over the other has yet been definitely demonstrated.  Objective:  To compare functional and surgical outcomes of LPN and RAPN.  Patients and Methods:  Between 2015 and 2019, we prospectively randomized 115 patients with cT1-T2 renal masses to LPN in total ischemia or RAPN in selective ischemia. Primary endpoint was RF preservation, assessed by renal scintigraphy (RS). RS assessments were performed preoperatively and at 6 months follow-up. Secondary endpoints included clinical, histopathologic, and surgical outcomes.  Results:  One hundred eight patients were included in the final analysis. Patient and tumor characteristics were comparable. No significant difference in RS values after 6 months was observed between both groups. Median (interquartile range) RF change after 6 months was -18.0% (-26.5 to -11.0) in LPN group and -20.0 (-33.2 to -12.0) in RAPN group ( p  = 0.3). Mean (standard deviation [SD]) warm ischemia time was 21.1 (6.1) minutes in LPN group and 19.6 (7.7) minutes in RAPN group ( p  = 0.2). No positive surgical margins (PSMs) occurred in the LPN group, whereas RAPN group had PSM in 4.9% ( n  = 3);  p  = 0.099. Renal volume loss after 6 months was 27.5% (22.7-45.7) in the LPN group  vs  37.5 (13.7-54.2) in the RAPN group ( p  = 0.5). Mean operative times were lower in the LPN group (192.3 minutes [SD 44.5]  vs  230.2 minutes [SD 59.6],  p  = 0.001). More complications occurred in the LPN group (31%  vs  21%,  p  = 0.075). Transfusion rates were 15% for LPN and 11% for RAPN.  Conclusions:  In terms of preserving RF, LPN in total ischemia and RAPN in selective ischemia are comparable. In most patients, RF decrease of the affected kidney after PN seems to not exceed 25%, regardless of the surgical approach.",2020,"Mean operative times were lower in the LPN group (192.3 min (SD 44.5) versus 230.2 min (SD 59.6), p=0.001).","['115 patients with cT1-T2 renal masses to LPN in total ischemia or RAPN in selective ischemia', 'Total Ischemia', '108 patients were included in the final analysis', 'Patients/Methods Between 2015 and 2019']","['RAPN', 'LPN', ' Laparoscopic partial nephrectomy (LPN) and robot-assisted partial nephrectomy (RAPN', 'Conventional Laparoscopic Partial Nephrectomy', 'Robot-assisted Laparoscopic Partial Nephrectomy', 'LPN and RAPN']","['Mean (SD) warm ischemia time', 'More complications', 'Median (IQR) RF change', 'positive surgical margins (PSM', 'Renal volume loss', 'Mean operative times', 'RF preservation, assessed by renal scintigraphy (RS', 'clinical, histopathological and surgical outcomes', 'Transfusion rates', 'RS values']","[{'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1438035', 'cui_str': 'SLC6A8 protein, human'}, {'cui': 'C0262613', 'cui_str': 'Renal mass'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C4039858', 'cui_str': 'Robot assisted laparoscopic partial nephrectomy'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C4039858', 'cui_str': 'Robot assisted laparoscopic partial nephrectomy'}, {'cui': 'C1144661', 'cui_str': 'Laparoscopic partial nephrectomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1563923', 'cui_str': 'Warm Ischemic Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C1310550', 'cui_str': 'Pteroylpoly-gamma-glutamate carboxypeptidase'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",115.0,0.0746323,"Mean operative times were lower in the LPN group (192.3 min (SD 44.5) versus 230.2 min (SD 59.6), p=0.001).","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Würnschimmel', 'Affiliation': 'Klinik für Urologie, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Giovanni Battista', 'Initials': 'GB', 'LastName': 'Di Pierro', 'Affiliation': 'Klinik für Urologie, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moschini', 'Affiliation': 'Klinik für Urologie, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Grande', 'Affiliation': 'Klinik für Urologie, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Baumeister', 'Affiliation': 'Klinik für Urologie, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Roth', 'Affiliation': 'Klinik für Radiologie, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Mordasini', 'Affiliation': 'Klinik für Urologie, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Mattei', 'Affiliation': 'Klinik für Urologie, Luzerner Kantonsspital, Luzern, Switzerland.'}]",Journal of endourology,['10.1089/end.2020.0143']
1411,32580990,"OASIS-a randomised, placebo-controlled trial of oral glucocorticoids for leg pain in patients with acute sciatica: trial protocol.","INTRODUCTION


Sciatica is a lower spine condition characterised by radiating leg pain below the knee. It may be accompanied by motor and sensory loss in the distribution of a spinal nerve. There are few effective treatments for sciatica. Orally administered glucocorticoids have shown some promise, however, any beneficial effects need to be confirmed and weighed against drug safety and cost-effectiveness, in a high-quality, definitive trial.
METHODS AND ANALYSIS


The Oral Steroids In Sciatica (OASIS) trial is a randomised, placebo-controlled, double-blind trial that will evaluate a tapering regimen of oral prednisolone in 200 participants with acute sciatica. Participants will be recruited on presentation to general practice, specialist outpatient clinics or hospital emergency departments and randomised to receive orally administered prednisolone 50 mg per day, up to 3 days then tapering to cessation over 10 days, or placebo, for a maximum of 13 days, in addition to guideline advice. Participants will be followed for 1 year. The primary endpoint will be leg pain intensity at 2 weeks. Secondary outcomes will include back pain intensity, disability, time to recovery, quality of life and treatment success rate. Adverse events will be assessed and a cost-effectiveness analysis will be conducted.
ETHICS AND DISSEMINATION


Ethical approval has been granted from the Human Research Ethics Committee, The University of Sydney. Trial results will be disseminated by publications and conference presentations and via the media.
TRIAL REGISTRATION NUMBER


ACTRN12619001716156.",2020,"(OASIS) trial is a randomised, placebo-controlled, double-blind trial that will evaluate a tapering regimen of oral prednisolone in 200 participants with acute sciatica.","['200 participants with acute sciatica', 'Participants will be recruited on presentation to general practice, specialist outpatient clinics or hospital emergency departments', 'patients with acute sciatica']","['oral prednisolone', 'oral glucocorticoids', 'glucocorticoids', 'prednisolone', 'placebo']","['leg pain', 'back pain intensity, disability, time to recovery, quality of life and treatment success rate', 'leg pain intensity']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0585051', 'cui_str': 'Acute sciatica'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",200.0,0.722215,"(OASIS) trial is a randomised, placebo-controlled, double-blind trial that will evaluate a tapering regimen of oral prednisolone in 200 participants with acute sciatica.","[{'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia chang.liu1@sydney.edu.au.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Abdel Shaheed', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'McLachlan', 'Affiliation': 'Sydney Pharmacy School, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Buchbinder', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Richard O', 'Initials': 'RO', 'LastName': 'Day', 'Affiliation': 'Department of Clinical Pharmacology & Toxicology, St Vincent Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Bethan', 'Initials': 'B', 'LastName': 'Richards', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Juliana S', 'Initials': 'JS', 'LastName': 'Oliveira', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}, {'ForeName': 'Chung-Wei Christine', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-040559']
1412,32585226,The effect of intrapartum O 2  supplementation on category II fetal monitoring.,"BACKGROUND


Maternal O 2  administration is a widely used intrauterine resuscitation technique for fetuses with category II electronic fetal monitoring patterns, despite a paucity of evidence on its ability to improve electronic fetal monitoring patterns.
OBJECTIVE


This study investigated the effect of intrapartum O 2  administration on Category II electronic fetal monitoring patterns.
STUDY DESIGN


This is a secondary analysis of a randomized trial conducted in 2016-2017, in which patients with fetuses at ≥37 weeks' gestation in active labor with category II electronic fetal monitoring patterns were assigned to 10 L/min of O 2  by face mask or room air until delivery. Trained obstetrical research nurses blinded to allocation extracted electronic fetal monitoring data. The primary outcome was a composite of high-risk category II features including recurrent variable decelerations, recurrent late decelerations, prolonged decelerations, tachycardia, or minimal variability 60 minutes after randomization to room air or O 2 . Secondary outcomes included individual components of the composite high-risk category II features, resolution of recurrent decelerations within 60 minutes of randomization, and total deceleration area. The outcomes between the room air and O 2  groups were compared using univariable statistics. Time-to-event analysis was used to compare time to resolution of recurrent decelerations between the groups. Paired analysis was used to compare the pre- and postrandomization outcomes within each group.
RESULTS


All 114 randomized patients (57 room air and 57 O 2 ) were included in this analysis. There was no difference in resolution of recurrent decelerations within 60 minutes between the O 2  and room air groups (75.4% vs 86.0%; P=.15). The room air and O 2  groups had similar rates of composite high-risk category II features including recurrent variable decelerations, recurrent late decelerations, prolonged decelerations, tachycardia, and minimal variability 60 minutes after randomization. Time to resolution of recurrent decelerations and total deceleration area were similar between the room air and O 2  groups. Among patients who received O 2 , there was no difference in the electronic fetal monitoring patterns pre- and postrandomization. Similar findings were observed in the electronic fetal monitoring patterns pre- and postrandomization in room air patients.
CONCLUSION


Intrapartum maternal O 2  administration for category II electronic fetal monitoring patterns did not resolve high-risk category II features or hasten the resolution of recurrent decelerations. These results suggest that O 2  administration has no impact on improving category II electronic fetal monitoring patterns.",2020,"There was no difference in resolution of recurrent decelerations within 60 minutes between O 2  and RA groups (75.4% vs 86.0%, p 0.15).","['2016-2017, in which patients ≥ 37 weeks in active labor with Category II EFM', 'RA patients', 'All 114 randomized patients (57 RA, 57 O 2 ) were included in this analysis']","['10 L/min O 2  by facemask or room air (RA) until delivery', 'Maternal oxygen (O 2 ) administration for Category II electronic fetal monitoring (EFM', 'intrapartum oxygen supplementation']","['resolution of recurrent decelerations', 'individual components of the composite, resolution of recurrent decelerations within 60 minutes of randomization and total deceleration area', 'Category II fetal monitoring', 'Time to resolution of recurrent decelerations and total deceleration area', 'rates of composite high risk Category II features including recurrent variables, recurrent lates, prolonged decelerations, tachycardia, and minimal variability 60 minutes', 'composite of high-risk Category II features including recurrent variable decelerations, recurrent late decelerations, prolonged decelerations, tachycardia or minimal variability 60 minutes after randomization to RA or O 2 ', 'EFM features']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0007208', 'cui_str': 'CTG, Antepartum'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0007208', 'cui_str': 'CTG, Antepartum'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}]","[{'cui': 'C2985322', 'cui_str': 'Recurrent fetal heart rate deceleration'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011100', 'cui_str': 'Deceleration'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0015945', 'cui_str': 'Foetal monitoring'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0457246', 'cui_str': 'Prolonged deceleration - finding'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C3805223', 'cui_str': 'Recurrent variable fetal heart rate deceleration'}, {'cui': 'C0429482', 'cui_str': 'Late fetal heart deceleration'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0007208', 'cui_str': 'CTG, Antepartum'}]",114.0,0.197232,"There was no difference in resolution of recurrent decelerations within 60 minutes between O 2  and RA groups (75.4% vs 86.0%, p 0.15).","[{'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Raghuraman', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO. Electronic address: nraghuraman@wustl.edu.'}, {'ForeName': 'Julia D', 'Initials': 'JD', 'LastName': 'López', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Ebony B', 'Initials': 'EB', 'LastName': 'Carter', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Molly J', 'Initials': 'MJ', 'LastName': 'Stout', 'Affiliation': 'Department of Obstetrics and Gynecology, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Macones', 'Affiliation': ""Department of Women's Health, Dell Medical School, University of Texas, Austin, TX.""}, {'ForeName': 'Methodius G', 'Initials': 'MG', 'LastName': 'Tuuli', 'Affiliation': 'Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Alison G', 'Initials': 'AG', 'LastName': 'Cahill', 'Affiliation': ""Department of Women's Health, Dell Medical School, University of Texas, Austin, TX.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.06.037']
1413,32584828,Potentials and pitfalls of increasing prosocial behavior and self-efficacy over time using an online personalized platform.,"BACKGROUND


This longitudinal mixed methods experimental study aimed to better understand the interplay between digital technology exposure over time, self-efficacy, and prosocial behavior in everyday contexts.
METHODS


66 psychology students tracked their daily prosocial behavior over three weeks. Additionally, half of the participants were randomly assigned to receive access to an online platform, which made personalized suggestions for prosocial actions to complete. Qualitative post-study interviews complemented quantitative measures.
RESULTS


Platform exposure had no measurable impact beyond that of tracking over time on either prosocial behavior or self-efficacy. Tracking increased self-efficacy to perform everyday prosocial actions, but did not affect self-efficacy to impact change. Prosocial behavior was predicted by self-efficacy to impact change. Enjoyment of the platform predicted completing higher numbers of suggested prosocial actions and was related to a higher likelihood to continue using the platform in the future. Avenues for increasing platform effectiveness include context-specific action personalization, an effective reminder system, and better support for the development of self-efficacy to impact change through meaningful actions.
CONCLUSION


Technology for prosocial behavior should be enjoyable, capable of being seamlessly integrated into everyday life, and ensure that suggested actions are perceived as meaningful in order to support the sustainable development of self-efficacy and prosocial behavior over time.",2020,Enjoyment of the platform predicted completing higher numbers of suggested prosocial actions and was related to a higher likelihood to continue using the platform in the future.,['66 psychology students tracked their'],[],"['prosocial behavior and self-efficacy', 'daily prosocial behavior', 'prosocial behavior or self-efficacy', 'self-efficacy', 'Prosocial behavior']","[{'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0040594', 'cui_str': 'Track'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",66.0,0.025428,Enjoyment of the platform predicted completing higher numbers of suggested prosocial actions and was related to a higher likelihood to continue using the platform in the future.,"[{'ForeName': 'Sharon T', 'Initials': 'ST', 'LastName': 'Steinemann', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Geelan', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Zaehringer', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Kamalatharsi', 'Initials': 'K', 'LastName': 'Mutuura', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Ewgenij', 'Initials': 'E', 'LastName': 'Wolkow', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Frasseck', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Opwis', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}]",PloS one,['10.1371/journal.pone.0234422']
1414,32584881,"Effect of maternal prenatal food supplementation, gestational weight gain, and breast-feeding on infant growth during the first 24 months of life in rural Vietnam.","Growth faltering among children during the first five years of life is a common problem among low and middle-income countries. The purpose of this study was to determine the effect of a nutrient-rich, food-based supplement given to Vietnamese rural women prior to and/or during pregnancy on the growth of their infants during first 24 months of life and to identify maternal and newborn factors associated with the infant's growth. This prospective cohort study included 236 infants born to mothers who had received nutritional advice or a food supplement from pre-conception to term or from mid-gestation to term as part of a prior randomized controlled trial. Infant anthropometry and feeding information were monitored monthly and the infant weight for age Z-score (WAZ), length for age Z-score (LAZ), and weight for length Z-score (WLZ) were assessed at 6, 12, 18, and 24 months of age using mixed-effects regression modeling. Compared to the non-supplemented mothers, infants born to mothers receiving food supplementation from mid-gestation to term had significantly higher WLZ only at 18 months (p = 0.03) and did not differ in other outcomes. Supplementation from pre-conception to term did not affect infant growth at any time point during the first 24 months. In the entire study cohort, maternal height and gestational weight gain were positively associated with the infant's WAZ and LAZ from 6 to 24 months of age. Programs designed to improve gestational weight gain among women performing demanding physical work throughout a reproductive cycle may improve postnatal infant growth. Trial registration: Registered Clinical Trials.Gov: NCT01235767.",2020,Supplementation from pre-conception to term did not affect infant growth at any time point during the first 24 months.,"['236 infants born to mothers who had received nutritional advice or a food supplement from pre-conception to term or from mid-gestation to term as part of a prior randomized controlled trial', 'rural Vietnam', ""Vietnamese rural women prior to and/or during pregnancy on the growth of their infants during first 24 months of life and to identify maternal and newborn factors associated with the infant's growth""]","['maternal prenatal food supplementation, gestational weight gain, and breast-feeding', 'nutrient-rich, food-based supplement']","['maternal height and gestational weight gain', 'infant weight for age Z-score (WAZ), length for age Z-score (LAZ), and weight for length Z-score (WLZ', 'WLZ', 'gestational weight gain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",236.0,0.0761669,Supplementation from pre-conception to term did not affect infant growth at any time point during the first 24 months.,"[{'ForeName': 'Phi N', 'Initials': 'PN', 'LastName': 'Quyen', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Hoang T', 'Initials': 'HT', 'LastName': 'Nga', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Chaffee', 'Affiliation': 'University of California San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Tu', 'Initials': 'T', 'LastName': 'Ngu', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'King', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, California, United States of America.""}]",PloS one,['10.1371/journal.pone.0233671']
1415,32590385,Mechanical Ventilation Strategy Guided by Transpulmonary Pressure in Severe Acute Respiratory Distress Syndrome Treated With Venovenous Extracorporeal Membrane Oxygenation.,"OBJECTIVES


Previous studies have suggested that adjusting ventilator settings based on transpulmonary pressure measurements may minimize ventilator-induced lung injury, but this has never been investigated in patients with severe acute respiratory distress syndrome supported with venovenous extracorporeal membrane oxygenation. We aimed to evaluate whether a transpulmonary pressure-guided ventilation strategy would increase the proportion of patients successfully weaned from venovenous extracorporeal membrane oxygenation support in patients with severe acute respiratory distress syndrome.
DESIGN


Single-center, prospective, randomized controlled trial.
SETTING


Sixteen-bed, respiratory ICU at a tertiary academic medical center.
PATIENTS


Severe acute respiratory distress syndrome patients receiving venovenous extracorporeal membrane oxygenation.
INTERVENTIONS


One-hundred four patients were randomized to transpulmonary pressure-guided ventilation group (n = 52) or lung rest strategy group (n = 52) groups. Two patients had cardiac arrest during establishment of venovenous extracorporeal membrane oxygenation in the lung rest group did not receive the assigned intervention. Thus, 102 patients were included in the analysis.
MEASUREMENTS AND MAIN RESULTS


The proportion of patients successfully weaned from venovenous extracorporeal membrane oxygenation in the transpulmonary pressure-guided group was significantly higher than that in the lung rest group (71.2% vs 48.0%; p = 0.017). Compared with the lung rest group, driving pressure, tidal volumes, and mechanical power were significantly lower, and positive end-expiratory pressure was significantly higher, in the transpulmonary pressure-guided group during venovenous extracorporeal membrane oxygenation support. In the transpulmonary pressure-guided group, levels of interleukin-1β, interleukin-6, and interleukin-8 were significantly lower, and interleukin-10 was significantly higher, than those of the lung rest group over time. Lung density was significantly lower in the transpulmonary pressure-guided group after venovenous extracorporeal membrane oxygenation support than in the lung rest group.
CONCLUSIONS


A transpulmonary pressure-guided ventilation strategy could increase the proportion of patients with severe acute respiratory distress syndrome successfully weaned from venovenous extracorporeal membrane oxygenation.",2020,"Lung density was significantly lower in the transpulmonary pressure-guided group after venovenous extracorporeal membrane oxygenation support than in the lung rest group.
","['102 patients were included in the analysis', 'Severe Acute Respiratory Distress Syndrome Treated With', 'Severe acute respiratory distress syndrome patients receiving', 'Sixteen-bed, respiratory ICU at a tertiary academic medical center', 'patients with severe acute respiratory distress syndrome', 'One-hundred four patients']","['transpulmonary pressure-guided ventilation strategy', 'venovenous extracorporeal membrane oxygenation', 'Mechanical Ventilation Strategy Guided by Transpulmonary Pressure', 'transpulmonary pressure-guided ventilation group (n = 52) or lung rest strategy group', 'Venovenous Extracorporeal Membrane Oxygenation', 'venovenous extracorporeal membrane oxygenation support']","['proportion of patients successfully weaned from venovenous extracorporeal membrane oxygenation', 'driving pressure, tidal volumes, and mechanical power', 'cardiac arrest', 'Lung density', 'positive end-expiratory pressure', 'levels of interleukin-1β, interleukin-6, and interleukin-8']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C5192099', 'cui_str': 'Venovenous extracorporeal membrane oxygenation'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}]",104.0,0.101497,"Lung density was significantly lower in the transpulmonary pressure-guided group after venovenous extracorporeal membrane oxygenation support than in the lung rest group.
","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'All authors: Department of Respiratory and Critical Care Medicine, Beijing Chao-Yang Hospital, Beijing Institute of Respiratory Medicine, Beijing Key Laboratory of Respiratory and Pulmonary Circulation Disorders, Capital Medical University, No. 8 Gongren Tiyuchang Nanlu, Chaoyang District, Beijing, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Xuyan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Hangyong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'Haichao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Chu', 'Affiliation': ''}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': ''}]",Critical care medicine,['10.1097/CCM.0000000000004445']
1416,32591370,A multicenter phase II randomized trial of durvalumab (MEDI-4736) versus physician's choice chemotherapy in recurrent ovarian clear cell adenocarcinoma (MOCCA).,"BACKGROUND


The optimal treatment of recurrent ovarian clear cell carcinoma remains unknown. There is increasing rationale to support the role of immune checkpoint inhibitors targeting the programmed cell death protein 1 (PD - 1)/programmed death-ligand 1 (PD-L1) axis in ovarian clear cell carcinoma.
PRIMARY OBJECTIVE


To evaluate the efficacy of durvalumab (MEDI-4736) compared with standard chemotherapy in patients with recurrent ovarian clear cell carcinoma.
STUDY HYPOTHESIS


Patients with recurrent ovarian clear cell carcinoma treated with durvalumab will have improved progression-free survival compared with those treated with chemotherapy of physician's choice.
TRIAL DESIGN


The MOCCA study is a multicenter, open-label, randomized phase II trial in patients with recurrent ovarian clear cell carcinoma, which recruited from eight sites across Gynecologic Cancer Group Singapore (GCGS), Korean Gynecologic-Oncology Group (KGOG), and Australia New Zealand Gynecological Oncology Group (ANZGOG). Enrolled patients were randomized in a 2:1 ratio to receive durvalumab or physician's choice of chemotherapy until disease progression, intolerable toxicity, or withdrawal of patient consent.
MAJOR INCLUSION/EXCLUSION CRITERIA


Eligible patients required histologically documented diagnosis of recurrent ovarian clear cell carcinoma, as evidenced by WT1 negativity. All patients must have been of Eastern Cooperative Oncology Group (ECOG) performance status 2 or better, and have had previous treatment with, and progressed or recurred after prior platinum-based chemotherapy. No more than four prior lines of treatment were allowed and prior immune checkpoint inhibitor treatment was not permitted.
PRIMARY ENDPOINTS


The primary endpoint was the median progression-free survival following treatment with durvalumab, compared with physician's choice of chemotherapy. Progression-free survival was defined as the time from the first day of treatment to the first observation of disease progression, or death due to any cause, or last follow-up.
SAMPLE SIZE


The target sample size was 46 patients.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS


Accrual has been completed and results are expected to be presented by mid-2021.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT03405454.",2020,"The primary endpoint was the median progression-free survival following treatment with durvalumab, compared with physician's choice of chemotherapy.","['recurrent ovarian clear cell adenocarcinoma (MOCCA', 'patients with recurrent ovarian clear cell carcinoma', '46 patients', 'All patients must have been of Eastern Cooperative Oncology Group (ECOG) performance status 2 or better, and have had previous treatment with, and progressed or recurred after prior platinum-based chemotherapy', 'Patients with recurrent ovarian clear cell carcinoma treated with', 'patients with recurrent ovarian clear cell carcinoma, which recruited from eight sites across Gynecologic Cancer Group Singapore (GCGS), Korean Gynecologic-Oncology Group (KGOG), and Australia New Zealand Gynecological Oncology Group (ANZGOG']","['standard chemotherapy', ""durvalumab or physician's choice of chemotherapy until disease progression, intolerable toxicity, or withdrawal of patient consent"", 'durvalumab', 'durvalumab (MEDI-4736', ""physician's choice chemotherapy""]","['progression-free survival', 'Progression-free survival', 'median progression-free survival']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1518693', 'cui_str': 'Clear cell adenocarcinoma of ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3544205', 'cui_str': 'Ovarian clear cell carcinoma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C3641122', 'cui_str': 'MEDI4736'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",46.0,0.0700606,"The primary endpoint was the median progression-free survival following treatment with durvalumab, compared with physician's choice of chemotherapy.","[{'ForeName': 'Natalie Yl', 'Initials': 'NY', 'LastName': 'Ngoi', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, Singapore.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Heong', 'Affiliation': 'Department of Medical Oncology, Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Ow', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, Singapore.'}, {'ForeName': 'Wen Yee', 'Initials': 'WY', 'LastName': 'Chay', 'Affiliation': 'Division of Medical Oncology, National Cancer Centre Singapore, Singapore.'}, {'ForeName': 'Hee Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Chel Hun', 'Initials': 'CH', 'LastName': 'Choi', 'Affiliation': 'Department of Obstetrics and Gynecology, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Goss', 'Affiliation': 'Box Hill Hospital, Box Hill, Victoria, Australia.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Goh', 'Affiliation': ""Royal Brisbane and Women's Hospital, Herston, Queensland, Australia.""}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Diana Gz', 'Initials': 'DG', 'LastName': 'Lim', 'Affiliation': 'Department of Pathology, National University Hospital, Singapore.'}, {'ForeName': 'Nivashini', 'Initials': 'N', 'LastName': 'Kaliaperumal', 'Affiliation': 'Institute of Molecular and Cell Biology, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'Veonice B', 'Initials': 'VB', 'LastName': 'Au', 'Affiliation': 'Institute of Molecular and Cell Biology, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Connolly', 'Affiliation': 'Institute of Molecular and Cell Biology, Agency for Science, Technology and Research, Singapore.'}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynecology, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'The Prince of Wales Hospital, Randwick, New South Wales, Australia.'}, {'ForeName': 'Kidong', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Bundang Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'David Sp', 'Initials': 'DS', 'LastName': 'Tan', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, Singapore david_sp_tan@nuhs.edu.sg.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2020-001604']
1417,32683735,Split-face comparison of grid fractional radiofrequency vs 1064-nm Nd-YAG laser treatment of periorbital rhytides among Filipino patients.,"Despite multiple individual studies proving efficacy of grid fractional monopolar radiofrequency (Grid RF) and near-infrared irradiation 1064-nm long-pulsed neodymium:YAG laser (Laser Genesis), there is a lack of controlled comparative trials between these devices. This study aims to compare the efficacy and safety of Grid RF versus Laser Genesis in the treatment of periorbital rhytides. This is a randomized, single-blind, split-face, prospective study. Eight patients with moderate to severe periorbital rhytides were treated with either Grid RF or Laser Genesis on each side of the face. Photographic and live assessment with the Lemperle Wrinkle Assessment grading scale was compared after 2 months. Difference in scores between Grid RF vs Laser genesis groups after 2 months was not statistically significant (P = 0.244). Each group showed statistically significant improvement months post-procedure (P < .05). Immediate adverse effects and satisfaction scale were similar for both groups (P > .05). At 2 months follow-up, no adverse effects were seen. Grid monopolar radiofrequency (Grid RF) vs near-infrared radiation 1064 nm long-pulsed Nd-YAG laser (Laser Genesis) were equally efficacious, safe, and well-tolerated among patients in the treatment of periorbital wrinkles (P > .05).",2020,"RESULTS


Difference in scores between Grid RF vs. Laser genesis groups after 2 months was not statistically significant (p=0.244) .","['periorbital rhytides among Filipino patients', 'Eight patients with moderate to severe periorbital rhytides']","['Grid monopolar radiofrequency (Grid RF) versus Near-infrared radiation 1064nm long-pulsed Nd-YAG laser (Laser Genesis', 'Grid RF vs. Laser genesis', 'grid fractional radiofrequency vs 1064-nm Nd-YAG laser treatment', 'Grid RF or Laser Genesis', 'Grid RF versus Laser Genesis', 'grid fractional monopolar radiofrequency (Grid RF) and near-infrared irradiation 1064-nm long-pulsed neodymium:YAG laser (Laser Genesis']","['Adverse events and patient satisfaction', 'efficacious, safe and well-tolerated', 'Immediate adverse effects and satisfaction scale', 'efficacy and safety', 'adverse effects']","[{'cui': 'C0230064', 'cui_str': 'Periorbital'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C1556093', 'cui_str': 'Filipinos'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0021431', 'cui_str': 'Infrared radiation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C4255166', 'cui_str': 'Genesis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",8.0,0.0201908,"RESULTS


Difference in scores between Grid RF vs. Laser genesis groups after 2 months was not statistically significant (p=0.244) .","[{'ForeName': 'Riza R', 'Initials': 'RR', 'LastName': 'Milante', 'Affiliation': 'Department of Dermatology, Jose R. Reyes Memorial Medical Center, Manila, Philippines.'}, {'ForeName': 'Melanie Joy', 'Initials': 'MJ', 'LastName': 'Doria-Ruiz', 'Affiliation': 'Department of Dermatology, Jose R. Reyes Memorial Medical Center, Manila, Philippines.'}, {'ForeName': 'Mercedes Buenviaje', 'Initials': 'MB', 'LastName': 'Beloso', 'Affiliation': 'Department of Dermatology, Jose R. Reyes Memorial Medical Center, Manila, Philippines.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Espinoza-Thaebtharm', 'Affiliation': 'Department of Dermatology, Jose R. Reyes Memorial Medical Center, Manila, Philippines.'}]",Dermatologic therapy,['10.1111/dth.14031']
1418,32600394,Repetitive transcranial magnetic stimulation of the prefrontal cortex for fibromyalgia syndrome: a randomised controlled trial with 6-months follow up.,"OBJECTIVES


Fibromyalgia Syndrome (FMS), is a chronic pain disorder with poorly understood pathophysiology. In recent years, repetitive transcranial magnetic stimulation (rTMS) has been recommended for pain relief in various chronic pain disorders. The objective of the present research was to study the effect of low frequency rTMS over the right dorsolateral prefrontal cortex (DLPFC) on pain status in FMS.
METHODS


Ninety diagnosed cases of FMS were randomized into Sham-rTMS and Real-rTMS groups. Real rTMS (1 Hz/1200 pulses/8 trains/90% resting motor threshold) was delivered over the right DLPFC for 5 consecutive days/week for 4 weeks. Pain was assessed by subjective and objective methods along with oxidative stress markers. Patients were followed up for 6 months (post-rTMS;15 days, 3 months and 6 months).
RESULTS


In Real-rTMS group, average pain ratings and associated symptoms showed significant improvement post rTMS. The beneficial effects of rTMS lasted up to 6 months in the follow-up phase. In Sham-rTMS group, no significant change in pain ratings was observed.
CONCLUSION


Right DLPFC rTMS can significantly reduce pain and associated symptoms of FMS probably through targeting spinal pain circuits and top-down pain modulation .
TRIAL REGISTRATION


Ref No: CTRI/2013/12/004228.",2020,"Right DLPFC rTMS can significantly reduce pain and associated symptoms of FMS probably through targeting spinal pain circuits and top-down pain modulation .
","['Ninety diagnosed cases of FMS', 'Fibromyalgia Syndrome (FMS', 'fibromyalgia syndrome']","['Real rTMS', 'Sham-rTMS', 'Right DLPFC rTMS', 'rTMS', 'Repetitive transcranial magnetic stimulation', 'repetitive transcranial magnetic stimulation (rTMS', 'low frequency rTMS', 'Sham-rTMS and Real-rTMS']","['average pain ratings', 'pain and associated symptoms of FMS', 'Pain', 'pain ratings']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]",90.0,0.0753615,"Right DLPFC rTMS can significantly reduce pain and associated symptoms of FMS probably through targeting spinal pain circuits and top-down pain modulation .
","[{'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Tanwar', 'Affiliation': 'Department of Physiology, AIIMS, New Delhi, 110029, India.'}, {'ForeName': 'Bhawna', 'Initials': 'B', 'LastName': 'Mattoo', 'Affiliation': 'Department of Physiology, AIIMS, New Delhi, 110029, India.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Kumar', 'Affiliation': 'Department of Rheumatology, All India Institute of Medical Sciences, AIIMS, New Delhi, 110029, India.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Bhatia', 'Affiliation': 'Department of Physiology, AIIMS, New Delhi, 110029, India. renuaiims28@gmail.com.'}]","Advances in rheumatology (London, England)",['10.1186/s42358-020-00135-7']
1419,32602065,Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme.,"INTRODUCTION


Ceftazidime-avibactam combines the established anti-pseudomonal cephalosporin, ceftazidime, with the novel non-β-lactam β-lactamase inhibitor, avibactam.
OBJECTIVES


The aim of this study was to evaluate the safety of ceftazidime-avibactam in adults using pooled data from two phase II (NCT00690378, NCT00752219) and five phase III (NCT01499290, NCT01726023, NCT01644643, NCT01808093 and NCT01595438/NCT01599806) clinical studies.
METHODS


Safety data from seven multicentre, randomised, active-comparator studies were pooled by study group at the patient level for descriptive analyses, comprising patients with complicated urinary tract infection (cUTI), including pyelonephritis, complicated intra-abdominal infection (cIAI), or nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP), treated with ceftazidime-avibactam ± metronidazole or comparator.
RESULTS


In total, 4050 patients (ceftazidime-avibactam ± metronidazole, n = 2024; comparator, n = 2026) were included in the pooled analysis. Adverse events (AEs) up to the last study visit occurred in 996 (49.2%) and 965 (47.6%) patients treated with ceftazidime-avibactam ± metronidazole and comparator, respectively. The most common AEs across treatment groups were diarrhoea, nausea, headache, vomiting and pyrexia. There were few discontinuations due to AEs (2.5% and 1.7% for ceftazidime-avibactam ± metronidazole and comparators, respectively). Overall rates of serious AEs were 8.7% for ceftazidime-avibactam ± metronidazole and 7.2% for comparators; respective rates of AEs with an outcome of death were 2.0% and 1.8%. AEs considered causally related to the study drug or procedures occurred in 10.7% and 9.6% of patients treated with ceftazidime-avibactam ± metronidazole and comparators; the most common drug-related AEs in both groups were diarrhoea, headache, nausea and increased alanine aminotransferase. No impact to the safety profile of ceftazidime-avibactam ± metronidazole was found with regard to intrinsic factors, such as age or renal function at baseline, or extrinsic factors, such as geographical origin. Potentially clinically significant changes in laboratory parameters were infrequent with no trends or safety concerns identified.
CONCLUSION


The observed safety profile of ceftazidime-avibactam across infection types is consistent with the established safety profile of ceftazidime monotherapy and no new safety findings were identified. This analysis supports the use of ceftazidime-avibactam as a treatment option in adults with cUTI, cIAI and NP, including VAP.",2020,"There were few discontinuations due to AEs (2.5% and 1.7% for ceftazidime-avibactam ± metronidazole and comparators, respectively).","['adults with cUTI, cIAI and NP, including VAP', 'patients with complicated urinary tract infection (cUTI), including pyelonephritis, complicated intra-abdominal infection (cIAI), or nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP), treated with ceftazidime-avibactam\u2009±\u2009metronidazole or comparator', '4050 patients (ceftazidime-avibactam\u2009±\u2009metronidazole, n\u2009=\u20092024; comparator, n\u2009=\u20092026']","['metronidazole', 'Ceftazidime-Avibactam', 'ceftazidime-avibactam\u2009±\u2009metronidazole', 'ceftazidime-avibactam']","['Overall rates of serious AEs', 'diarrhoea, headache, nausea and increased alanine aminotransferase', 'death', 'laboratory parameters', 'Adverse events (AEs', 'diarrhoea, nausea, headache, vomiting and pyrexia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4552431', 'cui_str': 'Complicated urinary tract infection'}, {'cui': 'C4524048', 'cui_str': 'Complicated intra-abdominal infection'}, {'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034186', 'cui_str': 'Pyelonephritis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3656596', 'cui_str': 'Avibactam and ceftazidime'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C3656596', 'cui_str': 'Avibactam and ceftazidime'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0151905', 'cui_str': 'Alanine aminotransferase increased'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",4050.0,0.0542547,"There were few discontinuations due to AEs (2.5% and 1.7% for ceftazidime-avibactam ± metronidazole and comparators, respectively).","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cheng', 'Affiliation': 'Pfizer, Sandwich, Kent, UK. karen.cheng@pfizer.com.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Newell', 'Affiliation': 'AstraZeneca, Alderley Park, Macclesfield, UK.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Chow', 'Affiliation': 'Pfizer, Collegeville, PA, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Broadhurst', 'Affiliation': 'AstraZeneca, Alderley Park, Macclesfield, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'AstraZeneca, Alderley Park, Macclesfield, UK.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Yates', 'Affiliation': 'AstraZeneca, Alderley Park, Macclesfield, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wardman', 'Affiliation': 'AstraZeneca, Alderley Park, Macclesfield, UK.'}]",Drug safety,['10.1007/s40264-020-00934-3']
1420,32606057,Elastic-band resistance exercise or vibration treatment in combination with hydroxymethylbutyrate (HMB) supplement for management of sarcopenia in older people: a study protocol for a single-blinded randomised controlled trial in Hong Kong.,"INTRODUCTION


Sarcopenia is a geriatric syndrome characterised by progressive loss of skeletal muscle mass and function with risks of adverse outcomes and becomes more prevalent due to ageing population. Elastic-band exercise, vibration treatment and hydroxymethylbutyrate (HMB) supplementation were previously proven to have positive effects on the control of sarcopenia. The purpose of this study is to evaluate the effectiveness of elastic-band exercise or vibration treatment with HMB supplementation in managing sarcopenia. Our findings will provide a safe and efficient strategy to mitigate the progression of sarcopenia in older people and contribute to higher quality of life as well as improved long-term health outcomes of elderly people.
METHODS AND ANALYSIS


In this single-blinded, randomised controlled trial (RCT), subjects will be screened for sarcopenia based on the Asian Working Group for Sarcopenia (AWGS) definition and 144 sarcopenic subjects aged 65 or above will be recruited. This RCT will have three groups evaluated at two time points to measure changes over 3 months-the control and the groups with combined HMB supplement and elastic-band resistance exercise or vibration treatment. Changes in muscle strength in lower extremity will be the primary outcome. Muscle strength in the upper extremity, gait speed, muscle mass (based on AWGS definition), functional performance in terms of balancing ability and time-up-and-go test and quality of life will be taken as secondary outcomes. In addition, each participant's daily activity will be monitored by a wrist-worn activity tracker. Repeated-measures analysis of variance will be performed to compare within-subject changes between control and treatment groups at two time points of pretreatments and post-treatments.
ETHICS AND DISSEMINATION


The procedures have been approved by the Joint CUHK-NTEC Clinical Research Management Office (Ref. CREC 2018.602) and conformed to the Declaration of Helsinki. Results will be disseminated through peer-reviewed publications, conferences and workshops.
TRIAL REGISTRATION NUMBER


NCT04028206.",2020,"Muscle strength in the upper extremity, gait speed, muscle mass (based on AWGS definition), functional performance in terms of balancing ability and time-up-and-go test and quality of life will be taken as secondary outcomes.","['older people', 'elderly people', 'subjects will be screened for sarcopenia based on the Asian Working Group for Sarcopenia (AWGS) definition and 144 sarcopenic subjects aged 65 or above will be recruited']","['Elastic-band resistance exercise or vibration treatment in combination with hydroxymethylbutyrate (HMB) supplement', 'Elastic-band exercise, vibration treatment and hydroxymethylbutyrate (HMB) supplementation', 'elastic-band exercise or vibration treatment with HMB supplementation']","['Muscle strength in the upper extremity, gait speed, muscle mass (based on AWGS definition), functional performance in terms of balancing ability and time-up-and-go test and quality of life']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0936732,"Muscle strength in the upper extremity, gait speed, muscle mass (based on AWGS definition), functional performance in terms of balancing ability and time-up-and-go test and quality of life will be taken as secondary outcomes.","[{'ForeName': 'Simon Kwoon-Ho', 'Initials': 'SK', 'LastName': 'Chow', 'Affiliation': 'Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Yu-Ning', 'Initials': 'YN', 'LastName': 'Chim', 'Affiliation': 'Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Keith Yu-Kin', 'Initials': 'KY', 'LastName': 'Cheng', 'Affiliation': 'Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Chung-Yan', 'Initials': 'CY', 'LastName': 'Ho', 'Affiliation': 'Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Wing-Tung', 'Initials': 'WT', 'LastName': 'Ho', 'Affiliation': 'Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}, {'ForeName': 'Kenneth Chik-Chee', 'Initials': 'KC', 'LastName': 'Cheng', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, New Territories, Hong Kong.'}, {'ForeName': 'Ronald Man-Yeung', 'Initials': 'RM', 'LastName': 'Wong', 'Affiliation': 'Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, Hong Kong ronald.wong2002@gmail.com.'}, {'ForeName': 'Wing-Hoi', 'Initials': 'WH', 'LastName': 'Cheung', 'Affiliation': 'Department of Orthopaedics and Traumatology, The Chinese University of Hong Kong, Hong Kong, Hong Kong.'}]",BMJ open,['10.1136/bmjopen-2019-034921']
1421,32606059,Effect of reactive balance training on physical fitness poststroke: study protocol for a randomised non-inferiority trial.,"INTRODUCTION


Regular exercise is essential in the chronic phase of stroke recovery for improving or maintaining function, and reducing the risk of a second stroke. To achieve these goals, multiple components of fitness should be targeted with poststroke exercise, including aerobic capacity, strength and balance. However, following the recommended frequency and duration of each component separately can take a long time and lead to fatigue in people with stroke. Therefore, finding types of exercise that target multiple components of fitness all together is valuable.Reactive balance training (RBT) is a novel type of exercise where individuals repeatedly lose their balance in order to practise balance reactions. When people do RBT, they increase their heart rate and exert forces with their leg muscles which could improve aerobic fitness and muscle strength, respectively. This means that RBT could have the potential to improve multiple components of fitness, simultaneously.
METHODS AND ANALYSIS


This is a randomised controlled non-inferiority trial with internal pilot study. Participants with chronic stroke will be randomly assigned to one of two groups: (1) RBT or (2) aerobic and strength training (AST). Participants in both groups will complete 1 hour of exercise, three times/week for 12 weeks. The primary objective is to determine the effect of RBT on aerobic capacity and knee muscles' strength. The secondary objective is to determine the effects of RBT and AST on balance control and balance confidence. We expect to find that RBT is superior to AST in terms of improving balance control and balance confidence, yet not inferior to AST in terms of its effects on aerobic capacity and strength.
ETHICS AND DISSEMINATION


Research ethics approval has been received. Results will be disseminated directly to study participants at the end of the trial, and to other stakeholders via publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


NCT04042961.",2020,"We expect to find that RBT is superior to AST in terms of improving balance control and balance confidence, yet not inferior to AST in terms of its effects on aerobic capacity and strength.
",['Participants with chronic stroke'],"['reactive balance training', 'Reactive balance training (RBT', 'RBT', 'RBT and AST', 'RBT or (2) aerobic and strength training (AST']","['aerobic fitness and muscle strength', 'balance control and balance confidence', 'heart rate', 'aerobic capacity and strength', ""aerobic capacity and knee muscles' strength"", 'physical fitness poststroke']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",,0.0572823,"We expect to find that RBT is superior to AST in terms of improving balance control and balance confidence, yet not inferior to AST in terms of its effects on aerobic capacity and strength.
","[{'ForeName': 'Azadeh', 'Initials': 'A', 'LastName': 'Barzideh', 'Affiliation': 'Rehabilitation Sciences Institute, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Marzolini', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Danells', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jagroop', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Huntley', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Inness', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Mathur', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Mochizuki', 'Affiliation': 'Kinesiology, York University, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Oh', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Avril', 'Initials': 'A', 'LastName': 'Mansfield', 'Affiliation': 'Toronto Rehabilitation Institute, University Health Network, Toronto, Ontario, Canada avril.mansfield@uhn.ca.'}]",BMJ open,['10.1136/bmjopen-2019-035740']
1422,32613714,Impact of periodontal therapy on systemic markers of inflammation in patients with metabolic syndrome: A randomized clinical trial.,"AIM


To determine the impact of periodontal treatment on systemic markers of inflammation in patients with metabolic syndrome (MetS) and periodontitis.
MATERIALS AND METHODS


In this parallel-arm, double-blind, randomized controlled clinical trial, 63 patients with MetS and severe periodontitis were randomly assigned to receive either intensive periodontal treatment (IPT; scaling and root planing plus azithromycin 500 mg every day for 3 days) or minimal periodontal treatment (MPT; supragingival professional mechanical plaque removal plus a placebo). The primary outcome was the impact of the tested interventions on high-sensitivity C-reactive protein (hs-CRP) serum levels at 6 months. As secondary outcomes, differences in the levels of cytokines, markers of prothrombotic states, carbohydrate and lipid metabolism, as well as blood pressure, were measured at 3 and 6 months after therapy.
RESULTS


The intention-to-treat population consisted of 63 subjects randomly assigned to either the MPT (n = 31) or the IPT (n = 32) group. At baseline, mean hs-CRP was 3.9 mg/L (standard deviation [SD] = 2.9) and 3.9 mg/L (SD = 3.4), respectively, and no significant differences in cardiometabolic risk profiles were detected between the groups. Adjusting for baseline hs-CRP, sex, age, smoking status and body mass index, hs-CRP at 6 months was 1.2 mg/L (95% CI 0.4; 2.0; P = .004) lower in the IPT group than in the MPT group. In the secondary outcomes, significant reductions in IL-1β, TNF-α, HbA1c and blood pressure were observed in the IPT group at 3 months compared with the MPT group.
CONCLUSION


Effective periodontal treatment significantly reduced hs-CRP after 6 months in patients with MetS and severe periodontitis. Periodontal therapy might be useful to reduce cardiovascular risk in these patients.",2020,"In the secondary outcomes, significant reductions in IL-1β, TNF-α, HbA1c and blood pressure were observed in the IPT group at 3 months, when compared to the MPT group.
","['patients with metabolic syndrome', 'patients with metabolic syndrome (MetS) and periodontitis', 'patients with MetS and severe periodontitis', '63 patients with MetS and severe periodontitis']","['IPT', 'MPT', 'minimal periodontal treatment (MPT; supragingival professional mechanical plaque removal plus a placebo', 'periodontal treatment', 'Periodontal therapy', 'intensive periodontal treatment (IPT; scaling and root planing plus azithromycin', 'periodontal therapy']","['levels of cytokines, markers of prothrombotic states, carbohydrate and lipids metabolism, as well as blood pressure', 'cardiovascular risk', 'IL-1β, TNF-α, HbA1c and blood pressure', 'cardiometabolic risk profiles', 'systemic markers of inflammation', 'mean hs-CRP', 'hs-CRP serum levels', 'hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",63.0,0.499139,"In the secondary outcomes, significant reductions in IL-1β, TNF-α, HbA1c and blood pressure were observed in the IPT group at 3 months, when compared to the MPT group.
","[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Montero', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'López', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Honorato', 'Initials': 'H', 'LastName': 'Vidal', 'Affiliation': 'Section of Graduate Periodontology, University Complutense, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Martínez', 'Affiliation': 'Section of Graduate Periodontology, University Complutense, Madrid, Spain.'}, {'ForeName': 'Leire', 'Initials': 'L', 'LastName': 'Virto', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Marrero', 'Affiliation': 'Internal Medicine Department, Fuenlabrada Hospital, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Herrera', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Zapatero', 'Affiliation': 'Internal Medicine Department, Fuenlabrada Hospital, Madrid, Spain.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Sanz', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14131']
1423,32398324,"Combination of PARP Inhibitor Olaparib, and PD-L1 Inhibitor Durvalumab, in Recurrent Ovarian Cancer: a Proof-of-Concept Phase II Study.","PURPOSE


Preclinical studies suggest PARP inhibition (PARPi) induces immunostimulatory micromilieu in ovarian cancer thus complementing activity of immune checkpoint blockade. We conducted a phase II trial of PARPi olaparib and anti-PD-L1 durvalumab and collected paired fresh core biopsies and blood samples to test this hypothesis.
PATIENTS AND METHODS


In a single-center, proof-of-concept phase II study, we enrolled women aged ≥18 with recurrent ovarian cancer. All patients were immune checkpoint inhibitor-naïve and had measurable disease per RECISTv1.1, ECOG performance status 0-2, and adequate organ and marrow function. Patients received olaparib 300 mg twice daily and durvalumab 1,500 mg intravenously every 4 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. Primary endpoint was overall response rate (ORR). Secondary objectives were safety and progression-free survival (PFS). Translational objectives included biomarker evaluation for relationships with clinical response and immunomodulatory effects by treatment.
RESULTS


Thirty-five patients with ovarian cancer [median, four prior therapies (IQR, 2-5.5), predominantly platinum-resistant (86%),  BRCA  wild-type (77%)] received at least one full cycle of treatment. ORR was 14% [5/35; 95% confidence interval (CI), 4.8%-30.3%]. Disease control rate (PR+SD) was 71% (25/35; 95% CI, 53.7%-85.4%). Treatment enhanced  IFNγ  and  CXCL9/CXCL10  expression, systemic IFNγ/TNFα production, and tumor-infiltrating lymphocytes, indicating an immunostimulatory environment. Increased IFNγ production was associated with improved PFS [HR, 0.37 (95% CI, 0.16-0.87),  P  = 0.023], while elevated VEGFR3 levels were associated with worse PFS (HR, 3.22 (95% CI, 1.23-8.40),  P  = 0.017].
CONCLUSIONS


The PARPi and anti-PD-L1 combination showed modest clinical activity in recurrent ovarian cancer. Our correlative study results suggest immunomodulatory effects by olaparib/durvalumab in patients and indicate that VEGF/VEGFR pathway blockade would be necessary for improved efficacy of the combination.",2020,"Increased IFNγ production was associated with improved PFS [HR, 0.37 (95% CI, 0.16-0.87),  P  = 0.023], while elevated VEGFR3 levels were associated with worse PFS (HR, 3.22 (95% CI, 1.23-8.40),  P  = 0.017].
","['recurrent ovarian cancer', 'enrolled women aged ≥18 with recurrent ovarian cancer', 'Thirty-five patients with ovarian cancer [median, four prior therapies (IQR, 2-5.5), predominantly platinum-resistant (86%),  BRCA  wild-type (77', 'Recurrent Ovarian Cancer']","['olaparib 300 mg twice daily and durvalumab', 'PARPi olaparib and anti-PD-L1 durvalumab and collected paired fresh core biopsies', 'PARP Inhibitor Olaparib, and PD-L1 Inhibitor Durvalumab', 'PARP inhibition (PARPi']","['IFNγ  and  CXCL9/CXCL10  expression, systemic IFNγ/TNFα production, and tumor-infiltrating lymphocytes', 'Disease control rate (PR+SD', 'overall response rate (ORR', 'safety and progression-free survival (PFS', 'ORR', 'elevated VEGFR3 levels', 'Increased IFNγ production']","[{'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C1567710', 'cui_str': 'PARP1 protein, human'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3657407', 'cui_str': 'vegfr3 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",35.0,0.174604,"Increased IFNγ production was associated with improved PFS [HR, 0.37 (95% CI, 0.16-0.87),  P  = 0.023], while elevated VEGFR3 levels were associated with worse PFS (HR, 3.22 (95% CI, 1.23-8.40),  P  = 0.017].
","[{'ForeName': 'Erika J', 'Initials': 'EJ', 'LastName': 'Lampert', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Zimmer', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Padget', 'Affiliation': 'Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Cimino-Mathews', 'Affiliation': 'Department of Pathology, The Johns Hopkins Medical Institution, Baltimore, Maryland.'}, {'ForeName': 'Jayakumar R', 'Initials': 'JR', 'LastName': 'Nair', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Yingmiao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': 'Division of Gynecologic Oncology, Departments of Obstetrics and Gynecology, University of Washington, Seattle, Washington.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Hodge', 'Affiliation': 'Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Nixon', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Nichols', 'Affiliation': 'Clinical Research Directorate, Frederick National Laboratory for Cancer Research sponsored by the National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Bagheri', 'Affiliation': 'Department of Radiology and Imaging Sciences, Clinical Center, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Levy', 'Affiliation': 'Interventional Radiology, NIH Clinical Center, Bethesda, Maryland.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Radke', 'Affiliation': 'Division of Gynecologic Oncology, Departments of Obstetrics and Gynecology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Lipkowitz', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Annunziata', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Janis M', 'Initials': 'JM', 'LastName': 'Taube', 'Affiliation': 'Department of Dermatopathology, The Johns Hopkins Medical Institution, Baltimore, Maryland.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Steinberg', 'Affiliation': 'Biostatistics and Data Management Section, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland. leej6@mail.nih.gov.""}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0056']
1424,32624377,"Transdermal buprenorphine patch versus oral celecoxib for pain management after total knee arthroplasty: An open- label, randomized controlled trial.","BACKGROUND


This study was performed to evaluate the analgesic efficacy and safety of transdermal buprenorphine (TDB) patched for post-operative pain control after total knee arthroplasty (TKA). The hypothesis was that patients receiving the TDB patch would have less pain in comparison to those treated with the oral COX-2 inhibitor celecoxib without increasing side effects.
PATIENTS AND METHODS


A total of 160 patients scheduled for primary TKA were randomly assigned to two groups: patients provided the TDB patch (10μg/h) (TDB group) and those provided oral celecoxib (CX group). The outcomes were pain scores measured using the visual analogue scale (VAS) during rest and activity, as well as morphine requirement, operated knee functional recovery and adverse events post-operatively.
RESULTS


The total morphine given during the first 72h post-operatively was significantly lower in the TDB group than CX group. The VAS scores were significantly lower in the TDB group than CX group during rest at 2, 4, 6, 12, 24 and 48h post-operatively, and during activity at 12, 24 and 48h and 3 days post-operatively. The mean range of motion on post-operative days (PD) 1, 2 and 3 were significantly greater in the TDB group. In addition, the Lysholm score was significantly higher in the TDB group on PD 3. There were no remarkable adverse events in either group.
DISCUSSION


Use of the TDB patch provides effective pain relief and reduces the requirement for rescue morphine without increasing side effects in comparison with oral celecoxib during the early post-operative stage following TKA.
LEVEL OF EVIDENCE


II.",2020,"The mean range of motion on post-operative days (PD) 1, 2 and 3 were significantly greater in the TDB group.","['160 patients scheduled for primary TKA', 'pain management after total knee arthroplasty']","['Transdermal buprenorphine patch versus oral celecoxib', 'TDB', 'oral COX-2 inhibitor celecoxib', 'TDB patch', 'celecoxib', 'transdermal buprenorphine', 'TDB patch (10μg/h) (TDB group) and those provided oral celecoxib (CX group', 'CX']","['mean range of motion on post-operative days (PD', 'Lysholm score', 'analgesic efficacy and safety', 'effective pain relief', 'adverse events', 'pain', 'pain scores measured using the visual analogue scale (VAS) during rest and activity, as well as morphine requirement, operated knee functional recovery and adverse events post-operatively', 'VAS scores']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1257954', 'cui_str': 'Cyclooxygenase-2 inhibitor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",160.0,0.0687527,"The mean range of motion on post-operative days (PD) 1, 2 and 3 were significantly greater in the TDB group.","[{'ForeName': 'Xinxian', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""The Osteopathy Department, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China.""}, {'ForeName': 'Linghui', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': 'The Radiology Department of Wenzhou Seventh Hospital, Hospital of Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Haixiao', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""The Osteopathy Department, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China.""}, {'ForeName': 'Yuezheng', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""The Osteopathy Department, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China. Electronic address: huyuezheng3@163.com.""}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.04.010']
1425,32632732,Adapted ERAS Pathway Versus Standard Care in Patients Undergoing Emergency Small Bowel Surgery: a Randomized Controlled Trial.,"BACKGROUND


Emergency laparotomy for small bowel pathologies comprises a significant number of all emergency surgeries. Application of evidence-based adapted enhanced recovery after surgery (ERAS) protocol can potentially improve the perioperative outcome in these procedures.
AIMS


To determine the feasibility, safety, and efficacy of adapted ERAS pathway in emergency small bowel surgery.
METHODOLOGY


This was a single-center, prospective, open-labeled, superiority, randomized controlled trial. Patients suspected to have small bowel pathology by the emergency surgical team were randomized preoperatively into standard care and adapted ERAS group. Patients with American Society of Anesthesiologist class ≥ 3, polytrauma patients with associated other intra-abdominal organ injuries, duodenal ulcer perforations, patients presenting with refractory shock, and pregnant patients were excluded. Primary outcome parameter was the length of hospitalization (LOH). Morbidity and other functional recovery parameters were also assessed.
RESULTS


Thirty-five patients were included in the adapted ERAS and standard care group. The laboratory and demographic variables were comparable. Patients in the ERAS group had significantly earlier recovery (days) in terms of first fluid diet (1.48 ± 0.18, p < 0.001), solid diet (2.11 ± 0.17, p < 0.001), time to first flatus (1.25 ± 0.24, p < 0.001), and first stool (1.8 ± 0.27, p < 0.001). Postoperative nausea, vomiting (RR 0.69, p = 0.19), pulmonary complications (RR 0.38, p = 0.16), superficial (RR 0.79, p = 0.33), and deep surgical site infections (RR 0.65, p = 0.39) were similar. Compared with the standard care group, ERAS group had significantly shorter LOH (8 ± 0.38 vs. 10.83 ± 0.42; Mean difference, 2.83 ± 0.56; p < 0.001).
CONCLUSION


Adapted ERAS pathways are feasible, safe, and significantly reduces the LOH in select patients undergoing emergency small bowel surgery.",2020,"CONCLUSION


Adapted ERAS pathways are feasible, safe, and significantly reduces the LOH in select patients undergoing emergency small bowel surgery.","['Patients with American Society of Anesthesiologist class ≥\u20093, polytrauma patients with associated other intra-abdominal organ injuries, duodenal ulcer perforations, patients presenting with refractory shock, and pregnant patients were excluded', 'Patients Undergoing Emergency Small Bowel Surgery', 'Patients suspected to have small bowel pathology by the emergency surgical team', 'Thirty-five patients were included in the adapted ERAS and standard care group', 'patients undergoing emergency small bowel surgery']","['Adapted ERAS Pathway Versus Standard Care', 'standard care and adapted ERAS', 'ERAS']","['time to first flatus', 'feasibility, safety, and efficacy', 'shorter LOH', 'Morbidity and other functional recovery parameters', 'pulmonary complications', 'length of hospitalization (LOH', 'deep surgical site infections', 'earlier recovery', 'Postoperative nausea, vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0026771', 'cui_str': 'Multiple injuries'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0740401', 'cui_str': 'Duodenal ulcer with perforation'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0349412', 'cui_str': 'Refractory shock'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0192571', 'cui_str': 'Operative procedure on small intestine'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}]",35.0,0.126187,"CONCLUSION


Adapted ERAS pathways are feasible, safe, and significantly reduces the LOH in select patients undergoing emergency small bowel surgery.","[{'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Saurabh', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Sathasivam', 'Initials': 'S', 'LastName': 'Sureshkumar', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Subair', 'Initials': 'S', 'LastName': 'Mohsina', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Thulasingam', 'Initials': 'T', 'LastName': 'Mahalakshmy', 'Affiliation': 'Department of Preventive Medicine, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Kundra', 'Affiliation': 'Anesthesia and Critical Care, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kate', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, 605006, India. drvikramkate@gmail.com.'}]",Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract,['10.1007/s11605-020-04684-6']
1426,32629032,Transcranial Direct Current Stimulation and Visual Illusion Effect According to Sensory Phenotypes in Patients With Spinal Cord Injury and Neuropathic Pain.,"Treatment of neuropathic pain (NP) in patients with spinal cord injury (SCI) remains a major challenge. The aim of the present study is to investigate if the effect of transcranial direct current stimulation combined with visual illusion, following a previously published protocol, has differential effects on pain-related sensory symptoms according to sensory phenotypes profiles. One hundred and thirty SCI patients with NP participated in this open-label trial. Sixty-five patients were given a daily 20-minutes combined treatment of transcranial direct current stimulation and visual illusion for 2 weeks. Sixty-five patients served as a control group. Clinical assessment was performed before and 2 weeks later, by using Neuropathic Pain Symptom Inventory (NPSI), Brief Pain Inventory, and Patient Health Questionnaire-9. There was significant improvement in the combined treatment group according to NPSI, Brief Pain Inventory, and Patient Health Questionnaire-9, but no changes in the control group. Following a cluster analysis of NPSI items at baseline assessment, 5 subgroups of patients with different pain-related characteristics were identified among the treated group, although differences between clusters were not significant. There was also improvement in mood, sleep quality, and enjoyment of life in the treated group. Despite a reduction of NP with the combined treatment, the analysis of sensory phenotype pain profiles does not provide a predictive value regarding the analgesic results of this combined neuromodulatory treatment. Perspective In this article we confirm the analgesic effect of a combined neuromodulatory therapy, transcranial direct current stimulation associated with visual illusion in patients with NP after an SCI. We have identified 5 clusters of NP with distinct sensory phenotypes, but there was not any specific sensory phenotype cluster that significantly responded to the combined therapy better than the other.",2020,"There was significant improvement in the combined treatment group according to NPSI, BPI and PHQ-9, but no changes in the control group.","['patients with spinal cord injury and neuropathic pain', 'patients with NP after an SCI', 'patients with spinal cord injury (SCI', 'One hundred and thirty SCI patients with NP']","['transcranial direct current stimulation (tDCS) combined with visual illusion (VI', 'Transcranial direct current stimulation and visual illusion', 'combined neuromodulatory therapy, transcranial direct current stimulation']","['NPSI, BPI and PHQ-9', 'mood, sleep quality, and enjoyment of life', 'neuropathic pain (NP', 'Neuropathic Pain Symptom Inventory (NPSI), Brief Pain Inventory (BPI), and Patient Health Questionnaire-9']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0751246', 'cui_str': 'Illusions, Visual'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0424131', 'cui_str': 'Enjoyment of life'}]",65.0,0.0870397,"There was significant improvement in the combined treatment group according to NPSI, BPI and PHQ-9, but no changes in the control group.","[{'ForeName': 'Dolors', 'Initials': 'D', 'LastName': 'Soler', 'Affiliation': ""Institut Guttmann Neurorehabilitation Institute, Badalona, Spain; Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol, Badalona, Spain. Electronic address: dsoler@guttmann.com.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Moriña', 'Affiliation': 'Barcelona Graduate School of Mathematics (BGSMath), Departament de Matemàtiques, Universitat Autònoma de Barcelona, Bellaterra, Spain.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Kumru', 'Affiliation': ""Institut Guttmann Neurorehabilitation Institute, Badalona, Spain; Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol, Badalona, Spain.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Vidal', 'Affiliation': ""Institut Guttmann Neurorehabilitation Institute, Badalona, Spain; Fundació Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol, Badalona, Spain.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Navarro', 'Affiliation': 'Institut Guttmann Neurorehabilitation Institute, Badalona, Spain; Department of Cell Biology, Physiology and Immunology, and Institute of Neurosciences, Universitat Autònoma de Barcelona, and CIBERNED, Bellaterra, Spain.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2020.06.004']
1427,32629078,Knowledge-Based Assessment of Focal Dose Escalation Treatment Plans in Prostate Cancer.,"PURPOSE


In a randomized focal dose escalation radiation therapy trial for prostate cancer (FLAME), up to 95 Gy was prescribed to the tumor in the dose-escalated arm, with 77 Gy to the entire prostate in both arms. As dose constraints to organs at risk had priority over dose escalation and suboptimal planning could occur, we investigated how well the dose to the tumor was boosted. We developed an anatomy-based prediction model to identify plans with suboptimal tumor dose and performed replanning to validate our model.
METHODS AND MATERIALS


We derived dose-volume parameters from planned dose distributions of 539 FLAME trial patients in 4 institutions and compared them between both arms. In the dose-escalated arm, we determined overlap volume histograms and derived features representing patient anatomy. We predicted tumor D98% with a linear regression on anatomic features and performed replanning on 21 plans.
RESULTS


In the dose-escalated arm, the median tumor D50% and D98% were 93.0 and 84.7 Gy, and 99% of the tumors had a dose escalation greater than 82.4 Gy (107% of 77 Gy). In both arms organs at risk constraints were met. Five out of 73 anatomic features were found to be predictive for tumor D98%. Median predicted tumor D98% was 4.4 Gy higher than planned D98%. Upon replanning, median tumor D98% increased by 3.0 Gy. A strong correlation between predicted increase in D98% and realized increase upon replanning was found (ρ = 0.86).
CONCLUSIONS


Focal dose escalation in prostate cancer was feasible with a dose escalation to 99% of the tumors. Replanning resulted in an increased tumor dose that correlated well with the prediction model. The model was able to identify tumors on which a higher boost dose could be planned. The model has potential as a quality assessment tool in focal dose escalated treatment plans.",2020,Replanning resulted in an increased tumor dose that correlated well with the prediction model.,"['539 [X] patients in 4 institutions and compared them between both arms', 'prostate cancer']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",[],[],,0.0291957,Replanning resulted in an increased tumor dose that correlated well with the prediction model.,"[{'ForeName': 'Marcel A', 'Initials': 'MA', 'LastName': 'van Schie', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands. Electronic address: m.v.schie@nki.nl.'}, {'ForeName': 'Tomas M', 'Initials': 'TM', 'LastName': 'Janssen', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Eekhout', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Walraven', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Floris J', 'Initials': 'FJ', 'LastName': 'Pos', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Ruiter', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'Alexis N T J', 'Initials': 'ANTJ', 'LastName': 'Kotte', 'Affiliation': 'University Medical Center Utrecht, Radiation Oncology, Utrecht, The Netherlands.'}, {'ForeName': 'Evelyn M', 'Initials': 'EM', 'LastName': 'Monninkhof', 'Affiliation': 'University Medical Center Utrecht, Radiation Oncology, Utrecht, The Netherlands.'}, {'ForeName': 'Linda G W', 'Initials': 'LGW', 'LastName': 'Kerkmeijer', 'Affiliation': 'University Medical Center Utrecht, Radiation Oncology, Utrecht, The Netherlands; Radboud University Medical Center, Radiation Oncology, Nijmegen, The Netherlands.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Draulans', 'Affiliation': 'University Hospitals Leuven, Radiation Oncology, Leuven, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'de Roover', 'Affiliation': 'University Hospitals Leuven, Radiation Oncology, Leuven, Belgium.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Haustermans', 'Affiliation': 'University Hospitals Leuven, Radiation Oncology, Leuven, Belgium.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kunze-Busch', 'Affiliation': 'Radboud University Medical Center, Radiation Oncology, Nijmegen, The Netherlands.'}, {'ForeName': 'Robert Jan', 'Initials': 'RJ', 'LastName': 'Smeenk', 'Affiliation': 'Radboud University Medical Center, Radiation Oncology, Nijmegen, The Netherlands.'}, {'ForeName': 'Uulke A', 'Initials': 'UA', 'LastName': 'van der Heide', 'Affiliation': 'Netherlands Cancer Institute, Radiation Oncology, Amsterdam, The Netherlands.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.072']
1428,32630079,Regular Consumption of Lipigo ®  Promotes the Reduction of Body Weight and Improves the Rebound Effect of Obese People Undergo a Comprehensive Weight Loss Program.,"Obesity is a global public health problem.
OBJECTIVE


To evaluate the effect of the regular consumption of the product Lipigo ®  on body weight and rebound effect on overweight/obese subjects undergoing a comprehensive weight loss program.
METHODS


A randomized, parallel, double-blind, placebo-controlled clinical trial was conducted with male and female subjects presenting a BMI 25-39.9 kg/m 2 . All subjects underwent a comprehensive weight loss program (WLP) for 12 weeks, which included an individualized hypocaloric diet, physical activity recommendations, nutritional education seminars, and three times a day consumption of the product Lipigo ®  or Placebo. After-WLP, subjects continued the treatment for 9 months to assess rebound effect. Body weight (BW), BMI, and body composition were measured at the beginning and the end of the WLP, and in the follow-up.
RESULTS


A total of 120 subjects (85% women) 49.0 ± 9.5 years old and with a BW of 81.57 ± 13.26 kg (BMI 31.19 ± 3.44 kg/m 2 ) were randomized and 73 subjects finished the study. At the end of the WLP, there was a tendency toward reduced BW (p = 0.093), BMI (p = 0.063), and WC (p = 0.059) in the treated group. However, subjects with obesity type 1 (OB1) from the treated group significantly reduced body weight (-5.27 ± 2.75 vs. -3.08 ± 1.73 kg; p = 0.017) and BMI (-1.99 ± 1.08 vs. -1.09 ± 0.55 kg/m 2 ; p = 0.01) compared with placebo. They also presented a minor rebound effect after 9 months with product consumption (-4.19 ± 3.61 vs. -1.44 ± 2.51 kg; p = 0.026), minor BMI (-1.61 ± 1.43 vs. -0.52 ± 0.96 kg/m 2 ; p = 0.025) and tended to have less fat-mass (-3.44 ± 2.46 vs. -1.44 ± 3.29 kg; p = 0.080) compared with placebo.
CONCLUSIONS


The regular consumption of the product Lipigo ®  promotes the reduction of body weight and reduces the rebound effect of obese people after 52 weeks (12 months), mainly in obesity type 1, who undergo a comprehensive weight loss program.",2020,"At the end of the WLP, there was a tendency toward reduced BW (p = 0.093), BMI (p = 0.063), and WC (p = 0.059) in the treated group.","['Obese People', '120 subjects (85% women) 49.0 ± 9.5 years old and with a BW of 81.57 ± 13.26 kg (BMI 31.19 ± 3.44 kg/m 2 ) were randomized and 73 subjects finished the study', 'overweight/obese subjects undergoing a comprehensive weight loss program', 'male and female subjects presenting a BMI 25-39.9 kg/m 2 ']","['comprehensive weight loss program (WLP', 'product Lipigo ®', 'individualized hypocaloric diet, physical activity recommendations, nutritional education seminars, and three times a day consumption of the product Lipigo ®  or Placebo', 'placebo']","['Body weight (BW), BMI, and body composition', 'body weight', 'BMI', 'Body Weight', 'reduced body weight', 'tendency toward reduced BW']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517899', 'cui_str': '9.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0204934', 'cui_str': 'Nutrition education'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0333779', 'cui_str': 'Reducing bodies'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",120.0,0.0992394,"At the end of the WLP, there was a tendency toward reduced BW (p = 0.093), BMI (p = 0.063), and WC (p = 0.059) in the treated group.","[{'ForeName': 'Marlhyn', 'Initials': 'M', 'LastName': 'Valero-Pérez', 'Affiliation': 'Nutrition Research Group, Hospital La Paz Institute for Health Research (IdiPAZ), 2804 Madrid, Spain.'}, {'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Bermejo', 'Affiliation': 'Nutrition Research Group, Hospital La Paz Institute for Health Research (IdiPAZ), Complutense University of Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Bricia', 'Initials': 'B', 'LastName': 'López-Plaza', 'Affiliation': 'Nutrition Research Group, Hospital La Paz Institute for Health Research (IdiPAZ), 2804 Madrid, Spain.'}, {'ForeName': 'Meritxell Aguiló', 'Initials': 'MA', 'LastName': 'García', 'Affiliation': 'AB-BIOTICS SA, Av. Torre Blanca 57, 08172 Sant Cugat del Valles, Spain.'}, {'ForeName': 'Samara', 'Initials': 'S', 'LastName': 'Palma-Milla', 'Affiliation': 'Nutrition Department, La Paz University Hospital, Nutrition Research Group, Hospital La Paz Institute for Health Research (IdiPAZ), Autonomous University of Madrid, 28046 Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Gómez-Candela', 'Affiliation': 'Nutrition Department, La Paz University Hospital, Nutrition Research Group, Hospital La Paz Institute for Health Research (IdiPAZ), Autonomous University of Madrid, 28046 Madrid, Spain.'}]",Nutrients,['10.3390/nu12071960']
1429,32371537,"NSABP B-41, a Randomized Neoadjuvant Trial: Genes and Signatures Associated with Pathologic Complete Response.","PURPOSE


In NSABP B-41, pathologic complete response (pCR) was associated with prolonged survival among women with HER2-positive operable breast cancer treated with neoadjuvant chemotherapy and lapatinib, trastuzumab, or the combination. We used a large human breast cancer gene expression panel to select candidate prognostic biomarkers for pCR among women treated with trastuzumab in NSABP B-41.
PATIENTS AND METHODS


Eligible patients had a baseline preadjuvant treatment core biopsy sample, known pCR status, and no withdrawal of consent. We analyzed extracted RNA using the human nCounter Breast Cancer 360 gene expression panel. Gene counts were normalized to housekeeping genes and transformed into logarithmic scale with base 2. To screen for candidate genes and metagene signatures prognostic of pCR, we used univariate logistic regression. Variable selection was done by multivariable logistic regression with lasso regularization.
RESULTS


Analyses of data from 130 patients revealed that a composite of gene expression from 19 genes and one gene signature appeared to predict pCR in women with HER2-positive early-stage breast cancer undergoing neoadjuvant chemotherapy with trastuzumab-containing regimens. The identified genes are involved in important pathways such as epithelial-mesenchymal transition, adhesion and migration, estrogen receptor signaling, DNA damage and repair, apoptosis, and proliferation. The AUC from a 10-fold cross-validation on predicting pCR, with these 20 genomic markers in a logistic regression model, was 0.73.
CONCLUSIONS


The expression level of  ERBB2, ESR1 , and a few other genomic markers was highly predictive of pCR after trastuzumab-containing regimens. These findings need to be validated and calibrated in future studies.",2020,"The expression level of  ERBB2, ESR1 , and a few other genomic markers was highly predictive of pCR after trastuzumab-containing regimens.","['130 patients', 'women with HER2-positive operable breast cancer treated with', 'Eligible patients had a baseline preadjuvant treatment core biopsy sample, known pCR status, and no withdrawal of consent', 'human nCounter Breast Cancer 360 gene expression panel', 'women with HER2-positive early-stage breast cancer undergoing neoadjuvant chemotherapy with trastuzumab-containing regimens']","['trastuzumab', 'neoadjuvant chemotherapy and lapatinib, trastuzumab']",[],"[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}]",[],,0.0832425,"The expression level of  ERBB2, ESR1 , and a few other genomic markers was highly predictive of pCR after trastuzumab-containing regimens.","[{'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Swain', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, MedStar Health, Washington, DC. sms248@georgetown.edu.'}, {'ForeName': 'Gong', 'Initials': 'G', 'LastName': 'Tang', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Heather Ann', 'Initials': 'HA', 'LastName': 'Brauer', 'Affiliation': 'NanoString Technologies, Inc., Seattle, Washington.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Goerlitz', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, MedStar Health, Washington, DC.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Lucas', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Robidoux', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Brent T', 'Initials': 'BT', 'LastName': 'Harris', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, MedStar Health, Washington, DC.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Bandos', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'NanoString Technologies, Inc., Seattle, Washington.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Eleftherios P', 'Initials': 'EP', 'LastName': 'Mamounas', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NSABP Foundation, Pittsburgh, Pennsylvania.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0152']
1430,32639465,Daptomycin for Pediatric Gram-Positive Acute Hematogenous Osteomyelitis.,"BACKGROUND


We prospectively evaluated efficacy and safety of daptomycin versus active comparator in children with acute hematogenous osteomyelitis (AHO).
METHODS


Randomized, controlled, double-blind, global, multicenter, phase 3 trial. Patients 1-17 years of age with suspected/confirmed AHO requiring hospitalization and intravenous therapy were randomized 1:1 to intravenous daptomycin (once-daily, age-adjusted doses) or comparator (vancomycin, nafcillin or equivalent) ≥4 days, followed by oral therapy (14-42 days total). Primary endpoint: protocol-defined clinical improvement by Day 5 in the modified intention-to-treat (MITT) population (confirmed AHO, ≥1 dose of study treatment); differences between study arms were evaluated using a prespecified 15% noninferiority margin for daptomycin.
RESULTS


Seventy-three patients per arm received treatment. Pathogens were isolated from 62% of patients (83% methicillin-susceptible Staphylococcus aureus, 9% methicillin-resistant S. aureus [MRSA]). Clinical improvement by Day 5 was observed in 55/71 (78%) daptomycin- and 58/70 (83%) comparator-treated MITT patients (95% confidence interval [CI]: -19.4, 7.4). This difference was not statistically significant; however, daptomycin did not meet the prespecified 15% noninferiority margin, since the lower bound of the 95% CI extended below 15%. Overall, 82% of daptomycin and 87% of comparator patients achieved clinical cure at the test-of-cure visit (secondary endpoint). More comparator patients had treatment-emergent (63% vs. 46%) and treatment-related (18% vs. 7%) adverse events.
CONCLUSIONS


Differences between daptomycin and comparator for the primary endpoint were not statistically significant; however, prespecified noninferiority criteria for daptomycin were not met. With insufficient cases of confirmed MRSA, we could not evaluate daptomycin for MRSA AHO. Our nonvalidated protocol design yields valuable information for implementing future trials in AHO (ClinicalTrials.gov NCT01922011).",2020,"comparator-treated MITT patients (95% confidence interval [CI]: -19.4, 7.4).","['Patients 1-17 years of age with suspected/confirmed AHO requiring hospitalization and intravenous therapy', 'children with acute hematogenous osteomyelitis (AHO']","['daptomycin', 'comparator (vancomycin, nafcillin or equivalent) ≥4 days, followed by oral therapy', 'intravenous daptomycin', 'Daptomycin']","['clinical cure', 'protocol-defined clinical improvement by Day 5 in the modified intention-to-treat (MITT) population (confirmed AHO, ≥1 dose of study treatment); differences', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0455142', 'cui_str': 'Intravenous therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0600123', 'cui_str': 'Acute hematogenous osteomyelitis'}]","[{'cui': 'C0057144', 'cui_str': 'Daptomycin'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0027324', 'cui_str': 'Nafcillin'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0600123', 'cui_str': 'Acute hematogenous osteomyelitis'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.601159,"comparator-treated MITT patients (95% confidence interval [CI]: -19.4, 7.4).","[{'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Bradley', 'Affiliation': ""From the Division of Infectious Diseases, Rady Children's Hospital San Diego, San Diego, CA.""}, {'ForeName': 'Antonio C', 'Initials': 'AC', 'LastName': 'Arrieta', 'Affiliation': ""Children's Hospital of Orange County, Orange, CA.""}, {'ForeName': 'Valeri A', 'Initials': 'VA', 'LastName': 'Digtyar', 'Affiliation': ""Dnipropetrovsk Regional Children's Clinical Hospital, Dnipropetrovsk, Ukraine.""}, {'ForeName': 'Myra W', 'Initials': 'MW', 'LastName': 'Popejoy', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Anjana', 'Initials': 'A', 'LastName': 'Grandhi', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Bokesch', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Ellie', 'Initials': 'E', 'LastName': 'Hershberger', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Dorr', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Tan', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Murata', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Dominik J', 'Initials': 'DJ', 'LastName': 'Wolf', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}, {'ForeName': 'Mekki', 'Initials': 'M', 'LastName': 'Bensaci', 'Affiliation': 'Merck Research Laboratories, Merck & Co, Inc., Kenilworth, NJ.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002790']
1431,32591464,A Phase II Study of Allogeneic GM-CSF-Transfected Pancreatic Tumor Vaccine (GVAX) with Ipilimumab as Maintenance Treatment for Metastatic Pancreatic Cancer.,"PURPOSE


This phase II study tested granulocyte-macrophage colony-stimulating factor (GM-CSF)-allogeneic pancreatic tumor cells (GVAX) and ipilimumab in metastatic pancreatic ductal adenocarcinoma (PDA) in the maintenance setting.
PATIENTS AND METHODS


Patients with PDA who were treated with front-line chemotherapy consisting of 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) in the metastatic setting and had ongoing response or stable disease after 8-12 doses were eligible. Patients were randomized 1:1 to treatment with GVAX and ipilimumab given every 3 weeks for four doses then every 8 weeks (Arm A) or to FOLFIRINOX continuation (Arm B). The primary objective was to compare overall survival (OS) between the two arms.
RESULTS


Eighty-two patients were included in the final analysis (Arm A: 40; Arm B: 42). The study was stopped for futility after interim analysis. Median OS was 9.38 months [95% confidence interval (CI), 5.0-12.2] for Arm A and 14.7 months (95% CI, 11.6-20.0) for Arm B (HR, 1.75;  P  = 0.019). Using immune-related response criteria, two partial responses (5.7%) were observed in Arm A and four (13.8%) in Arm B. GVAX + ipilimumab promoted T-cell differentiation into effector memory phenotypes both in the periphery and in the tumor microenvironment and increased M1 macrophages in the tumor.
CONCLUSIONS


GVAX and ipilimumab maintenance therapy did not improve OS over continuation of chemotherapy and resulted in a numerically inferior survival in metastatic PDA. However, clinical responses and biological effects on immune cells were observed. Further study of novel combinations in the maintenance treatment of metastatic PDA is feasible.",2020,"Median overall survival (OS) was 9.38 months (95% CI: 5.0, 12.2) for Arm A and 14.7 months","['metastatic pancreatic ductal adenocarcinoma (PDA', 'Patients with PDA who were treated with front-line chemotherapy consisting of', 'FOLFIRINOX) in the metastatic setting and had ongoing response or stable disease after 8-12 doses were eligible', 'Metastatic Pancreatic Cancer', 'Eighty-two patients were included in the final analysis (Arm A: 40; Arm B: 42']","['GVAX and ipilimumab', 'Ipilimumab', 'Allogeneic GM-CSF Transfected Pancreatic Tumor Vaccine (GVAX', '5-fluorouracil, leucovorin, irinotecan, and oxaliplatin', 'granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells (GVAX) and ipilimumab']","['Median overall survival (OS', 'overall survival (OS', 'M1 macrophages']","[{'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0030297', 'cui_str': 'Neoplasm of pancreas'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}]",82.0,0.0811801,"Median overall survival (OS) was 9.38 months (95% CI: 5.0, 12.2) for Arm A and 14.7 months","[{'ForeName': 'Annie A', 'Initials': 'AA', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Bever', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Won Jin', 'Initials': 'WJ', 'LastName': 'Ho', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Elana J', 'Initials': 'EJ', 'LastName': 'Fertig', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Niu', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zheng', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Rose M', 'Initials': 'RM', 'LastName': 'Parkinson', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Durham', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Onners', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Anna K', 'Initials': 'AK', 'LastName': 'Ferguson', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Wilt', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ko', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, UCSF Helen Diller Family Comprehensive Cancer Center at University of California, San Francisco, California.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wang-Gillam', 'Affiliation': 'Department of Internal Medicine, Division of Oncology at Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Laheru', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Anders', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth D', 'Initials': 'ED', 'LastName': 'Thompson', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Jaffee', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dung T', 'Initials': 'DT', 'LastName': 'Le', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center, The Skip Viragh Center for Pancreas Cancer Clinical Research and Patient Care, and The Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University School of Medicine, Baltimore, Maryland. dle@jhmi.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1025']
1432,32593717,Caring for older veterans with chronic low back pain using a geriatric syndrome approach: Rationale and methods for the aging back clinics (ABC) trial.,"The purpose of the ongoing trial is to improve care of older Veterans with chronic low back pain (CLBP, i.e., low back pain for ≥6 months on ≥ half the days). Current CLBP care is limited by being either overly spine-focused or non-specifically prescribed and both approaches frequently lead to suboptimal reduction in pain and improvement in function. Through prior studies we have laid the foundation for a patient-centered approach to care for older Veterans with CLBP in which the spine is a source of vulnerability but not the sole treatment target. The approach considers CLBP a geriatric syndrome, a final common pathway for the expression of multiple contributors rather than a disease of the spine. We describe here the rationale and design of a randomized controlled trial to test the efficacy of an older Veteran-centered approach to CLBP care in ""Aging Back Clinics (ABCs)"" compared with Usual Care (UC). Three hundred thirty Veterans age 65-89 with CLBP will be randomized to ABCs or UC and followed for 12 months after randomization. We will assess the impact of ABCs on our primary outcome of pain-associated disability with the Oswestry Disability Index at 6 and 12 months, and secondary outcomes of pain intensity, health-related quality of life, balance confidence, mobility and healthcare utilization. If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.",2020,"If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.","['Three hundred thirty Veterans age 65-89 with CLBP', 'older Veterans with chronic low back pain (CLBP, i.e., low back pain for ≥6\u202fmonths on ≥ half the days', 'older veterans with chronic low back pain using a geriatric syndrome approach', 'older adults with CLBP']","['ABCs or UC', 'older Veteran-centered approach to CLBP care', 'Usual Care (UC']","['pain-associated disability with the Oswestry Disability Index', 'pain intensity, health-related quality of life, balance confidence, mobility and healthcare utilization']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",330.0,0.0631505,"If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.","[{'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Weiner', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America; University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America. Electronic address: debra.weiner@va.gov.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Gentili', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Meika A', 'Initials': 'MA', 'LastName': 'Fang', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Garay', 'Affiliation': 'VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Thiru', 'Initials': 'T', 'LastName': 'Annaswamy', 'Affiliation': 'VA North Texas Health Care System, Dallas, TX, United States of America; University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Castle', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Lenore', 'Initials': 'L', 'LastName': 'Joseph', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lawson', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Cathy C', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Una E', 'Initials': 'UE', 'LastName': 'Makris', 'Affiliation': 'VA North Texas Health Care System, Dallas, TX, United States of America; University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Michelle I', 'Initials': 'MI', 'LastName': 'Rossi', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America; University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Thorn', 'Affiliation': 'University of Alabama, Tuscaloosa, AL, United States of America.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Clemens', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Newman', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America; University of Pittsburgh Graduate School of Public Health, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106077']
1433,32595137,Evaluation of the General Practice Pharmacist (GPP) intervention to optimise prescribing in Irish primary care: a non-randomised pilot study.,"OBJECTIVE


Limited evidence suggests integration of pharmacists into the general practice team could improve medicines management for patients, particularly those with multimorbidity and polypharmacy. This study aimed to develop and assess the feasibility of an intervention involving pharmacists, working within general practices, to optimise prescribing in Ireland.
DESIGN


Non-randomised pilot study.
SETTING


Primary care in Ireland.
PARTICIPANTS


Four general practices, purposively sampled and recruited to reflect a range of practice sizes and demographic profiles.
INTERVENTION


A pharmacist joined the practice team for 6 months (10 hours/week) and undertook medication reviews (face to face or chart based) for adult patients, provided prescribing advice, supported clinical audits and facilitated practice-based education.
OUTCOME MEASURES


Anonymised practice-level medication (eg, medication changes) and cost data were collected. Patient-reported outcome measure (PROM) data were collected on a subset of older adults (aged ≥65 years) with polypharmacy using patient questionnaires, before and 6 weeks after medication review by the pharmacist.
RESULTS


Across four practices, 786 patients were identified as having 1521 prescribing issues by the pharmacists. Issues relating to deprescribing medications were addressed most often by the prescriber (59.8%), compared with cost-related issues (5.8%). Medication changes made during the study equated to approximately €57 000 in cost savings assuming they persisted for 12 months. Ninety-six patients aged ≥65 years with polypharmacy were recruited from the four practices for PROM data collection and 64 (66.7%) were followed up. There were no changes in patients' treatment burden or attitudes to deprescribing following medication review, and there were conflicting changes in patients' self-reported quality of life.
CONCLUSIONS


This non-randomised pilot study demonstrated that an intervention involving pharmacists, working within general practices is feasible to implement and has potential to improve prescribing quality. This study provides rationale to conduct a randomised controlled trial to evaluate the clinical and cost-effectiveness of this intervention.",2020,"There were no changes in patients' treatment burden or attitudes to deprescribing following medication review, and there were conflicting changes in patients' self-reported quality of life.
","['Ninety-six patients aged ≥65 years with polypharmacy were recruited from the four practices for PROM data collection and 64 (66.7%) were followed up', 'Irish primary care', '786 patients were identified as having 1521 prescribing issues by the pharmacists', 'Primary care in Ireland', 'Four general practices, purposively sampled and recruited to reflect a range of practice sizes and demographic profiles']",['General Practice Pharmacist (GPP) intervention'],"['quality of life', 'Anonymised practice-level medication (eg, medication changes) and cost data']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1553352', 'cui_str': 'Irish Gaelic language'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]","[{'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",96.0,0.0952408,"There were no changes in patients' treatment burden or attitudes to deprescribing following medication review, and there were conflicting changes in patients' self-reported quality of life.
","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cardwell', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Clyne', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'McCullagh', 'Affiliation': ""National Centre for Pharmacoeconomics, St James's University Teaching Hospital, Dublin, Ireland.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Wallace', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'Kirke', 'Affiliation': 'National Quality Improvement Team, Health Service Executive, Dublin, Ireland.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Fahey', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Moriarty', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland frankmoriarty@rcsi.ie.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035087']
1434,32595142,"Randomised, double-blinded, placebo-controlled trial to investigate the role of laparoscopic transversus abdominis plane block in gastric bypass surgery: a study protocol.","INTRODUCTION


Evaluating the efficacy of a laparoscopically guided, surgical transversus abdominis plane (TAP) and rectus sheath (RS) block in reducing analgesic consumption while improving functional outcomes in patients undergoing laparoscopic bariatric surgery.
METHODS


150 patients Living with obesity undergoing elective laparoscopic Roux-En-Y gastric bypass for obesity will be recruited to this double-blinded, placebo-controlled randomised controlled trial from a Bariatric Centre of Excellence over a period of 6 months. Patients will be electronically randomised on a 1:1 basis to either an intervention or placebo group. Those on the intervention arm will receive a total of 60 mL 0.25% ropivacaine, divided into four injections: two for TAP and two for RS block under laparoscopic visualisation. The placebo arm will receive normal saline in the same manner. A standardised surgical and anaesthetic protocol will be followed, with care in adherence to the Enhanced Recovery after Bariatric Surgery guidelines.
ANALYSIS


Demographic information and relevant medical history will be collected from the 150 patients enrolled in the study. Our primary efficacy endpoint is cumulative postoperative narcotic use. Secondary outcomes are peak expiratory flow, postoperative pain score and the 6 min walk test. Quality of recovery (QoR) will be assessed using a validated questionnaire (QoR-40). Statistical analysis will be conducted to assess differences within and between the two groups. The repeated measures will be analysed by a mixed modelling approach and results reported through publication.
ETHICS AND DISSEMINATION


Ethics approval was obtained (20170749-01H) through our institutional research ethics board (Ottawa Health Science Network Research Ethics Board) and the study results, regardless of the outcome, will be reported in a manuscript submitted for a medical/surgical journal.
TRIAL REGISTRATION NUMBER


Pre-results NCT03367728.",2020,"INTRODUCTION


Evaluating the efficacy of a laparoscopically guided, surgical transversus abdominis plane (TAP) and rectus sheath (RS) block in reducing analgesic consumption while improving functional outcomes in patients undergoing laparoscopic bariatric surgery.
","['150 patients enrolled in the study', 'patients undergoing laparoscopic bariatric surgery', '150 patients Living with obesity undergoing elective laparoscopic Roux-En-Y gastric bypass for obesity', 'gastric bypass surgery']","['normal saline', 'ropivacaine', 'TAP and two for RS block under laparoscopic visualisation', 'laparoscopically guided, surgical transversus abdominis plane (TAP) and rectus sheath (RS) block', 'laparoscopic transversus abdominis plane block', 'placebo']","['Quality of recovery (QoR', 'cumulative postoperative narcotic use', 'peak expiratory flow, postoperative pain score and the 6\u2009min walk test']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",150.0,0.709073,"INTRODUCTION


Evaluating the efficacy of a laparoscopically guided, surgical transversus abdominis plane (TAP) and rectus sheath (RS) block in reducing analgesic consumption while improving functional outcomes in patients undergoing laparoscopic bariatric surgery.
","[{'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Jarrar', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada ajarrar.md@gmail.com.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Budiansky', 'Affiliation': 'Department of Anesthesia, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Eipe', 'Affiliation': 'Department of Anesthesia, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Caolan', 'Initials': 'C', 'LastName': 'Walsh', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Kolozsvari', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Neville', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Mamazza', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2018-025818']
1435,32599071,"A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous NSCLC: Protocol-Specified Final Analysis of KEYNOTE-407.","INTRODUCTION


In the randomized KEYNOTE-407 study (ClinicalTrials.gov, NCT02775435), pembrolizumab plus carboplatin and paclitaxel/nab-paclitaxel (chemotherapy) significantly improved overall survival (OS) and progression-free survival (PFS) compared with placebo plus chemotherapy in patients with previously untreated metastatic squamous NSCLC. We report updated efficacy outcomes from the protocol-specified final analysis and, for the first time, progression on next line of treatment.
METHODS


Eligible patients were randomized to chemotherapy plus either pembrolizumab (n = 278) or placebo (n = 281). After positive results from the second interim analysis, patients still receiving placebo could cross over to pembrolizumab monotherapy at the time of confirmed progressive disease. The primary end points were OS and PFS. PFS-2 (time from randomization to progression on next-line treatment/death, whichever occurred first) was an exploratory end point.
RESULTS


After median (range) follow-up of 14.3 (0.1-31.3) months, pembrolizumab plus chemotherapy continued to exhibit a clinically meaningful improvement over placebo plus chemotherapy in OS (median, 17.1 mo [95% confidence interval (CI): 14.4‒19.9] versus 11.6 mo [95% CI: 10.1‒13.7]; hazard ratio [HR], 0.71 [95% CI: 0.58‒0.88]) and PFS (median, 8.0 mo [95% CI: 6.3‒8.4] versus 5.1 mo [95% CI: 4.3‒6.0]; HR, 0.57 [95% CI: 0.47‒0.69]). PFS-2 was longer for patients randomized to first-line pembrolizumab plus chemotherapy (HR, 0.59 [95% CI: 0.49‒0.72]). Grade 3 to 5 adverse events occurred in 74.1% and 69.6% of patients receiving pembrolizumab plus chemotherapy and placebo plus chemotherapy, respectively.
CONCLUSIONS


Pembrolizumab plus chemotherapy continued to exhibit substantially improved OS and PFS in patients with metastatic squamous NSCLC. The PFS-2 outcomes support pembrolizumab plus chemotherapy as a standard first-line treatment in patients with metastatic squamous NSCLC.",2020,"Grade 3‒5 adverse events occurred in 74.1% and 69.6% of patients receiving pembrolizumab plus chemotherapy and placebo plus chemotherapy, respectively.
","['Patients With Metastatic Squamous Non-Small-Cell Lung Cancer', 'patients with previously untreated metastatic squamous non-small-cell lung cancer (NSCLC', 'Eligible patients', 'patients with metastatic squamous NSCLC']","['chemotherapy plus either pembrolizumab', 'Placebo', 'Pembrolizumab plus chemotherapy', 'Pembrolizumab Plus Chemotherapy', 'placebo plus chemotherapy', 'pembrolizumab monotherapy', 'pembrolizumab plus carboplatin and paclitaxel/nab-paclitaxel (chemotherapy', 'pembrolizumab plus chemotherapy', 'pembrolizumab plus chemotherapy and placebo plus chemotherapy', 'placebo']","['Grade 3‒5 adverse events', 'PFS', 'OS and PFS', 'PFS-2', 'overall survival (OS) and progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.574421,"Grade 3‒5 adverse events occurred in 74.1% and 69.6% of patients receiving pembrolizumab plus chemotherapy and placebo plus chemotherapy, respectively.
","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario 12 de Octubre, H12o-CNIO Lung Cancer Unit, Universidad Complutense & Ciberonc, Madrid, Spain. Electronic address: lpazaresr@seom.org.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Department of Clinical Oncology, Hospital Universitario Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tafreshi', 'Affiliation': 'Wollongong Oncology, Wollongong Private Hospital, Wollongong, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Cancer Centre of Southeastern Ontario, Kingston General Hospital, Kingston, Ontario, Canada.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Soto Parra', 'Affiliation': 'Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele, Catania, Italy.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazières', 'Affiliation': 'Hôpital Larrey, Centre Hospitalier Universitaire Toulouse, Toulouse, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hermes', 'Affiliation': 'Universitätskinikum Tübingen, Tuebingen, Germany.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Cicin', 'Affiliation': 'Department of Medical Oncology, Trakya University, Edirne, Turkey.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Medgyasszay', 'Affiliation': 'Veszprém Megyei Tüdőgyógyintézet Farkasgyepű, Farkasgyepű, Hungary.'}, {'ForeName': 'Jerónimo', 'Initials': 'J', 'LastName': 'Rodríguez-Cid', 'Affiliation': 'Oncology Center, Medica Sur Hospital, Mexico City, Mexico.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Department of Medicine and Surgery, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'SungSook', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Hematology-Oncology, Inje University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Rodryg', 'Initials': 'R', 'LastName': 'Ramlau', 'Affiliation': 'Department of Oncology, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Vladimirov', 'Affiliation': 'Pyatigorsk Oncology Dispensary, State Healthcare Institute, Pyatigorsk, Russia.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': ""Department of Oncology, Cancer Hospital of Jilin Province, Changchun, People's Republic of China.""}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'HTA Statistics Europe, Merck Sharp & Dohme, Brussels, Belgium.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Bas', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Halmos', 'Affiliation': 'Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2020.06.015']
1436,32599148,Measuring Goal-Concordant Care: Results and Reflections From Secondary Analysis of a Trial to Improve Serious Illness Communication.,"CONTEXT


Many consider goal-concordant care (GCC) to be the most important of advance care planning and palliative care. Researchers face significant challenges in attempting to measure this outcome. We conducted a randomized controlled trial to assess the effects of a system-level intervention to improve serious illness communication on GCC and other outcomes.
OBJECTIVES


To describe our measurement approach to GCC, present findings from a post-hoc analysis of trial data, and discuss lessons learned about measuring GCC.
METHODS


Using trial data collected to measure GCC, we analyzed ratings and rankings from a nonvalidated survey of patient priorities in the setting of advanced cancer, the Life Priorities Scale, and compared outcomes with correlative measures.
RESULTS


Participants commonly rated several predetermined and literature-derived priorities as important but did so in ways that were commonly incongruent with rankings. Ratings were frequently stable over time; rankings less so. Rankings are more likely to help assess the degree to which care is goal concordant but may be best augmented by corollary measures that signal achievement of a given priority.
CONCLUSION


Measuring GCC remains a fundamental challenge to palliative care researchers. Ratings attest to the fact that many things matter to patients; however, rankings can better determine what matters most. Insights gained from our experience may guide future research aiming to use this outcome to assess the effect of intervention to improve serious illness care.",2020,Ratings were frequently stable over time; rankings less so.,[],"['GCC', 'system-level intervention']",[],[],"[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0544069,Ratings were frequently stable over time; rankings less so.,"[{'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Sanders', 'Affiliation': ""Harvard Medical School, Boston, MA, USA; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA; Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA; Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA. Electronic address: jsanders@ariadnelabs.org.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Olaf P', 'Initials': 'OP', 'LastName': 'Geerse', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA; Department of Pulmonary Diseases, Academic Medical Center, Amsterdam, The Netherlands.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Paladino', 'Affiliation': ""Harvard Medical School, Boston, MA, USA; Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA; Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kavanagh', 'Affiliation': ""Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA; Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lakin', 'Affiliation': ""Harvard Medical School, Boston, MA, USA; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Neville', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Block', 'Affiliation': ""Harvard Medical School, Boston, MA, USA; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA; Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA; Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA; Department of Psychiatry, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Erik K', 'Initials': 'EK', 'LastName': 'Fromme', 'Affiliation': ""Harvard Medical School, Boston, MA, USA; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA; Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA; Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Bernacki', 'Affiliation': ""Harvard Medical School, Boston, MA, USA; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA; Ariadne Labs, Brigham and Women's Hospital and Harvard T. H. Chan School of Public Health, Boston, MA, USA; Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.06.023']
1437,32610465,Effects of Daily Probiotics Supplementation on Anxiety Induced Physiological Parameters among Competitive Football Players.,"Competitive football players who undergo strenuous training and frequent competitions are more vulnerable to psychological disorders. Probiotics are capable of reducing these psychological disorders. The present study aimed to determine the effect of daily probiotics supplementation on anxiety induced physiological parameters among competitive football players. The randomized, double-blinded, placebo-controlled trial was conducted on 20 male footballers who received either probiotics ( Lactobacillus Casei  Shirota strain 3 × 10 10  colony forming units (CFU) or a placebo drink over eight weeks. Portable biofeedback devices were used to measure the electroencephalography, heart rate, and electrodermal responses along with cognitive tests at the baseline, week 4, and week 8. Data were statistically analyzed using mixed factorial ANOVA and results revealed that there is no significant difference between the probiotic and placebo groups for heart rate (61.90 bpm ± 5.84 vs. 67.67 bpm ± 8.42,  p =  0.09) and electrodermal responses (0.27 µS ± 0.19 vs. 0.41 µS ± 0.12,  p  = 0.07) after eight weeks. Similarly, brain waves showed no significant changes during the study period except for the theta wave and delta wave at week 4 ( p <  0.05). The cognitive test reaction time (digit vigilance test) showed significant improvement in the probiotic group compared to the placebo ( p <  0.05). In conclusion, these findings suggest that daily probiotics supplementation may have the potential to modulate the brain waves namely, theta (relaxation) and delta (attention) for better training, brain function, and psychological improvement to exercise. Further research is needed to elucidate the mechanism of current findings.",2020,The cognitive test reaction time (digit vigilance test) showed significant improvement in the probiotic group compared to the placebo ( p <  0.05).,"['Competitive Football Players', 'competitive football players', '20 male footballers who received either']","['daily probiotics supplementation', 'Daily Probiotics Supplementation', 'probiotics ( Lactobacillus Casei  Shirota strain 3 × 10 10  colony forming units (CFU) or a placebo drink', 'placebo']","['electrodermal responses', 'cognitive test reaction time (digit vigilance test', 'electroencephalography, heart rate, and electrodermal responses', 'heart rate']","[{'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0016989', 'cui_str': 'Galvanic skin response'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",20.0,0.177127,The cognitive test reaction time (digit vigilance test) showed significant improvement in the probiotic group compared to the placebo ( p <  0.05).,"[{'ForeName': 'A M G C P', 'Initials': 'AMGCP', 'LastName': 'Adikari', 'Affiliation': 'Sports Science Programme, Faculty of Sports Science and Recreation, Universiti Teknologi MARA, Shah Alam, Selangor 40450, Malaysia.'}, {'ForeName': 'Mahenderan', 'Initials': 'M', 'LastName': 'Appukutty', 'Affiliation': 'Sports Science Programme, Faculty of Sports Science and Recreation, Universiti Teknologi MARA, Shah Alam, Selangor 40450, Malaysia.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Kuan', 'Affiliation': 'Exercise and Sport Science Programme, School of Health Sciences, Universiti Sains Malaysia, Kubang Kerian Kelantan 16150, Malaysia.'}]",Nutrients,['10.3390/nu12071920']
1438,32610481,"Caffeine-Containing, Adaptogenic-Rich Drink Modulates the Effects of Caffeine on Mental Performance and Cognitive Parameters: A Double-Blinded, Placebo-Controlled, Randomized Trial.","Using a placebo-controlled, double-blinded, within-participants, randomized, cross-over design, we examined the neurocognitive effects of a: (a) caffeine-containing, adaptogenic herbal-rich natural energy shot (e+ shot), (b) a matched caffeine-containing shot (caffeine), and, (c) a placebo. Participants ( n  = 30) were low consumers of caffeine without elevated feelings of energy. Before and three times after beverage consumption, a 27-min battery was used to assess motivation to perform cognitive tasks, mood, attention ((serial subtractions of 3 (SS3) and 7 (SS7), the continuous performance task (CPT), and the rapid visual input processing tasks)), heart rate (HR), blood pressure (BP), and motor coordination (nine-hole peg test) with a 10-min break between each post-consumption battery. The procedure was repeated for each beverage for each participant at least 48 h apart and within 30 min the same time of day using a random group assignment with blinding of researchers and subjects. To evaluate for changes in outcomes, a Treatment × Time analysis of covariance controlling for hours of prior night's sleep was used. Analysis of all outcomes and all treatment comparisons indicated that compared to placebo, both e+ shot ( Δ ¯ &nbsp; = 2.60; η 2  = 0.098) and caffeine ( Δ ¯ &nbsp; = 5.30, η 2  = 0.098) increased systolic BP 30 min post consumption (still within normal healthy ranges). The caffeine beverage also led to an improvement in most cognitive measures and moods 30-min post-consumption with improvements tapering at 69 and 108 min, while e+ shot noted more steady improvements with no significant differences between beverages on most cognitive and mood measures at 69 and 108 min. However, compared to caffeine, e+ shot noted a significant increase in reaction time at 108 min, while caffeine noted a small change in the opposite direction. No side-effects were reported by any intervention. These results suggest that the specific blend of adaptogens in e+ shot may modulate the neurocognitive effects of caffeine on mood, and cognition.",2020,"The caffeine beverage also led to an improvement in most cognitive measures and moods 30-min post-consumption with improvements tapering at 69 and 108 min, while e+ shot noted more steady improvements with no significant differences between beverages on most cognitive and mood measures at 69 and 108 min.",[],"['Placebo', 'caffeine', 'Caffeine', 'Caffeine-Containing, Adaptogenic-Rich Drink', 'caffeine-containing, adaptogenic herbal-rich natural energy shot (e+ shot), (b) a matched caffeine-containing shot (caffeine), and, (c) a placebo', 'placebo']","['Mental Performance and Cognitive Parameters', 'reaction time', 'motivation to perform cognitive tasks, mood, attention ((serial subtractions of 3 (SS3) and 7 (SS7), the continuous performance task (CPT), and the rapid visual input processing tasks)), heart rate (HR), blood pressure (BP), and motor coordination (nine-hole peg test) with a 10-min break between each post-consumption battery', 'systolic BP 30 min post consumption']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C4329232', 'cui_str': 'AX-CPT'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]",30.0,0.16417,"The caffeine beverage also led to an improvement in most cognitive measures and moods 30-min post-consumption with improvements tapering at 69 and 108 min, while e+ shot noted more steady improvements with no significant differences between beverages on most cognitive and mood measures at 69 and 108 min.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Boolani', 'Affiliation': 'Department of Physical Therapy, Clarkson University, Potsdam, NY 13699, USA.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Fuller', 'Affiliation': 'Department of Mathematics, Clarkson University, Potsdam, NY 13699, USA.'}, {'ForeName': 'Sumona', 'Initials': 'S', 'LastName': 'Mondal', 'Affiliation': 'Department of Mathematics, Clarkson University, Potsdam, NY 13699, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Chemistry and Biomolecular Science, Clarkson University, Potsdam, NY 13699, USA.'}, {'ForeName': 'Costel C', 'Initials': 'CC', 'LastName': 'Darie', 'Affiliation': 'Department of Chemistry and Biomolecular Science, Clarkson University, Potsdam, NY 13699, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gumpricht', 'Affiliation': 'Isagenix International, LLC, Gilbert, AZ 85297, USA.'}]",Nutrients,['10.3390/nu12071922']
1439,32615951,Crowdsourcing to promote hepatitis C testing and linkage-to-care in China: a randomized controlled trial protocol.,"BACKGROUND


Hepatitis C virus (HCV) is a growing public health problem with a large disease burden worldwide. In China many people living with HCV are unaware of their hepatitis status and not connected to care and treatment. Crowdsourcing is a technique that invites the public to create health promotion materials and has been found to increase HIV testing uptake, including in China. This trial aims to evaluate crowdsourcing as a strategy to improve HCV awareness, testing and linkage-to-care in China.
METHODS


A randomized controlled, two-armed trial (RCT) is being conducted in Shenzhen with 1006 participants recruited from primary care sectors of The University of Hong Kong-Shenzhen Hospital. Eligible participants are ≥30 years old; a resident in Shenzhen for at least one month after recruitment; no screening for HCV within the past 12 months and not known to have chronic HCV; and, having a WeChat social media account. Allocation is 1:1. Both groups will be administered a baseline and a follow-up survey (4-week post-enrollment). The intervention group will receive crowdsourcing materials to promote HCV testing once a week for two weeks and feedback will be collected thereafter, while the control group will receive no promotional materials. Feedback collected will be judged by a panel and selected to be implemented to improve the intervention continuously. Those identified positive for HCV antibodies will be referred to gastroenterologists for confirmation and treatment. The primary outcome will be confirmed HCV testing uptake, and secondary outcomes include HCV confirmatory testing and initiation of HCV treatment with follow-ups with specialist providers. Data will be collected on Survey Star @  via mobile devices.
DISCUSSION


This will be the first study to evaluate the impact of crowdsourcing to improve viral hepatitis testing and linkage-to-care in the health facilities. This RCT will contribute to the existing literature on interventions to improve viral hepatitis testing in primary care setting, and inform future strategies to improve HCV care training for primary care providers in China.
TRIAL REGISTRATION


Chinese Clinical Trial Registry. ChiCTR1900025771. Registered September 7th, 2019, http://www.chictr.org.cn/showprojen.aspx?proj=42788.",2020,"Crowdsourcing is a technique that invites the public to create health promotion materials and has been found to increase HIV testing uptake, including in China.","['primary care providers in China', 'China', 'Shenzhen with 1006 participants recruited from primary care sectors of The University of Hong Kong-Shenzhen Hospital', 'Eligible participants are ≥30\u2009years old; a resident in Shenzhen for at least one month after recruitment; no screening for HCV within the past 12\u2009months and not known to have chronic HCV; and, having a WeChat social media account']","['crowdsourcing materials to promote HCV testing', 'control group will receive no promotional materials']","['confirmed HCV testing uptake, and secondary outcomes include HCV confirmatory testing and initiation of HCV treatment with follow-ups with specialist providers']","[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439673', 'cui_str': 'Unknown'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]",1006.0,0.0962497,"Crowdsourcing is a technique that invites the public to create health promotion materials and has been found to increase HIV testing uptake, including in China.","[{'ForeName': 'William C W', 'Initials': 'WCW', 'LastName': 'Wong', 'Affiliation': 'Department of General Practice, HKU-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Yang', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'University of North Carolina Project-China, 1 Global Health Center Office, 2nd Floor of Lao Gan Building, No. 7 Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province, Guangzhou, China. jingjingli@seshglobal.org.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of General Practice, HKU-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Eric Y F', 'Initials': 'EYF', 'LastName': 'Wan', 'Affiliation': 'Department of Family Medicine and Primary Care, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fitzpatrick', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'University of North Carolina Project-China, 1 Global Health Center Office, 2nd Floor of Lao Gan Building, No. 7 Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province, Guangzhou, China.'}, {'ForeName': 'Wai-Kay', 'Initials': 'WK', 'LastName': 'Seto', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Polin', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': 'World Health Organization Western Pacific Regional Office, Manila, Philippines.'}, {'ForeName': 'Ruihong', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of General Practice, HKU-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina Project-China, 1 Global Health Center Office, 2nd Floor of Lao Gan Building, No. 7 Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province, Guangzhou, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina Project-China, 1 Global Health Center Office, 2nd Floor of Lao Gan Building, No. 7 Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province, Guangzhou, China.'}]",BMC public health,['10.1186/s12889-020-09152-z']
1440,32618279,"Safety and immunogenicity of a Zika purified inactivated virus vaccine given via standard, accelerated, or shortened schedules: a single-centre, double-blind, sequential-group, randomised, placebo-controlled, phase 1 trial.","BACKGROUND


The development of an effective vaccine against Zika virus remains a public health priority. A Zika purified inactivated virus (ZPIV) vaccine candidate has been shown to protect animals against Zika virus challenge and to be well tolerated and immunogenic in humans up to 8 weeks of follow-up. We aimed to assess the safety and immunogenicity of ZPIV in humans up to 52 weeks of follow-up when given via standard or accelerated vaccination schedules.
METHODS


We did a single-centre, double-blind, randomised controlled, phase 1 trial in healthy adults aged 18-50 years with no known history of flavivirus vaccination or infection at Beth Israel Deaconess Medical Center in Boston, MA, USA. Participants were sequentially enrolled into one of three groups: ZPIV given at weeks 0 and 4 (standard regimen), weeks 0 and 2 (accelerated regimen), or week 0 alone (single-dose regimen). Within each group, participants were randomly assigned using a computer-generated randomisation schedule to receive an intramuscular injection of 5 μg ZPIV or saline placebo, in a ratio of 5:1. The sponsor, clinical staff, investigators, participants, and laboratory personnel were masked to treatment assignment. The primary endpoint was safety up to day 364 after final dose administration, and secondary endpoints were proportion of participants with positive humoral immune responses (50% microneutralisation titre [MN 50 ] ≥100) and geometric mean MN 50  at observed peak response (ie, the highest neutralising antibody level observed for an individual participant across all timepoints) and week 28. All participants who received at least one dose of ZPIV or placebo were included in the safety population; the analysis of immunogenicity at observed peak included all participants who received at least one dose of ZPIV or placebo and had any adverse events or immunogenicity data after dosing. The week 28 immunogenicity analysis population consisted of all participants who received ZPIV or placebo and had immunogenicity data available at week 28. This trial is registered with ClinicalTrials.gov, NCT02937233.
FINDINGS


Between Dec 8, 2016, and May 17, 2017, 12 participants were enrolled into each group and then randomly assigned to vaccine (n=10) or placebo (n=2). There were no serious or grade 3 treatment-related adverse events. The most common reactions among the 30 participants who received the vaccine were injection-site pain (24 [80%]), fatigue (16 [53%]), and headache (14 [46%]). A positive response at observed peak titre was detected in all participants who received ZPIV via the standard regimen, in eight (80%) of ten participants who received ZPIV via the accelerated regimen, and in none of the ten participants who received ZPIV via the single-dose regimen. The geometric mean of all individual participants' observed peak values was 1153·9 (95% CI 455·2-2925·2) in the standard regimen group, 517·7 (142·9-1875·6) in the accelerated regimen group, and 6·3 (3·7-10·8) in the single-dose regimen group. At week 28, a positive response was observed in one (13%) of eight participants who received ZPIV via the standard regimen and in no participant who received ZPIV via the accelerated (n=7) or single-dose (n=10) regimens. The geomteric mean titre (GMT) at this timepoint was 13·9 (95% CI 3·5-55·1) in the standard regimen group and 6·9 (4·0-11·9) in the accelerated regimen group; antibody titres were undetectable at 28 weeks in participants who received ZPIV via the single-dose regimen. For all vaccine schedules, GMTs peaked 2 weeks after the final vaccination and declined to less than 100 by study week 16. There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
INTERPRETATION


ZPIV was safe and well tolerated in humans up to 52 weeks of follow-up. ZPIV immunogenicity required two doses and was not durable. Additional studies of ZPIV to optimise dosing schedules are ongoing.
FUNDING


The Henry M Jackson Foundation for the Advancement of Military Medicine.",2020,"There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
","['healthy adults aged 18-50 years with no known history of flavivirus vaccination or infection at Beth Israel Deaconess Medical Center in Boston, MA, USA']","['intramuscular injection of 5 μg ZPIV or saline placebo', 'ZPIV or placebo', 'Zika purified inactivated virus vaccine', 'vaccine', 'ZPIV', 'placebo']","['headache', 'Safety and immunogenicity', 'fatigue', 'ZPIV immunogenicity', 'geomteric mean titre (GMT', 'injection-site pain', 'adverse events or immunogenicity data', 'safety and immunogenicity', 'proportion of participants with positive humoral immune responses', 'serious or grade 3 treatment-related adverse events', ' antibody titres', 'geometric mean MN 50  at observed peak response (ie, the highest neutralising antibody level', 'positive response', 'peak titre', 'observed peak GMTs']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0016215', 'cui_str': 'Flavivirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0276289', 'cui_str': 'Zika virus disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0276289', 'cui_str': 'Zika virus disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",12.0,0.542669,"There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494).
","[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Chen Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hale', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA; Larner College of Medicine, Burlington, VT, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Moseley', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Kayvon', 'Initials': 'K', 'LastName': 'Modjarrad', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30085-2']
1441,32620339,Hepatic Adaptation to Therapeutic Doses of Acetaminophen: An Exploratory Study in Healthy Individuals.,"PURPOSE


Acetaminophen (APAP) has hepatotoxic potential when overdosed. Recent studies have reported serum alanine aminotransferase (ALT) elevations that resolve spontaneously with continued use of the drug, referred to as adaptation, in several individuals receiving therapeutic doses of APAP. However, the clinical significance of these ALT elevations remains unclear. This study was performed to investigate the incidence and characteristics of hepatic adaptation to therapeutic doses of APAP in healthy individuals.
METHODS


In a randomized, single-blind, placebo-controlled study, 242 healthy Japanese individuals were enrolled. Each person received 3 g/d of APAP (n = 202) or placebo (n = 40) for 28 days. All study participants underwent analysis of genetic polymorphisms of CYP2E1 and UGT1A1; measurements of plasma APAP concentration and urine metabolites (glucuronide, sulfate, cysteine, and mercapturate); liver function monitoring, including ALT, microRNA-122, and high-mobility group box 1. Individuals with ALT levels remaining below the upper limit of normal (ULN; 40 U/L) during the study period were defined as tolerant and those with ALT elevations above the ULN as susceptible. Susceptible individuals who developed ALT elevations exceeding 2 × ULN discontinued use of the study drug for tolerability consideration. Susceptible individuals who had ALT elevations that decreased toward the ULN spontaneously with continued use of the study drug were classified as adaptation.
FINDINGS


In the APAP group, 129 individuals (66%) were classified as tolerant and 65 (34%) as susceptible. Among 65 susceptible individuals, 12 (18%) discontinued use of APAP because of ALT elevations (>2 × ULN), whereas 53 (82%) completed 28-day APAP dosing. Thirty of 65 susceptible individuals (46%) had adaptation within 28 days. In the placebo group, no individuals was withdrawn from the study because of elevated ALT levels, 33 individuals (89%) were classified as tolerant, and 4 (11%) were classified as susceptible. None had clinical signs of liver injury. ALT level correlated significantly with microRNA-122 but not with high-mobility group box 1. No association was found between plasma APAP concentrations and ALT levels. Urinary excretion of APAP mercapturate was higher in susceptible than in tolerant individuals (P = 0.018, Wilcoxon or Kruskal-Wallis test). The frequency of homozygotes and compound heterozygotes for UGT1A1∗28 and UGT1A1∗6 (∗28/∗28, ∗6/∗6, and ∗6/∗28) was higher in susceptible than in tolerant individuals (13.9% vs 3.9%; P = 0.011, χ 2  test).
IMPLICATIONS


These findings indicate that in healthy individuals, APAP at a therapeutic dose can cause transient and self-limiting ALT elevation, reflecting subclinical hepatocellular damage, and these ALT elevations may be associated with the disposition of APAP metabolites and genetic factors. UMIN-CTR identifier: UMIN000019607.",2020,"Urinary excretion of APAP mercapturate was higher in susceptible than in tolerant individuals (P = 0.018, Wilcoxon or Kruskal-Wallis test).","['Thirty of 65 susceptible individuals (46%) had adaptation within 28 days', 'healthy Individuals', '242 healthy Japanese individuals were enrolled', 'healthy individuals']","['APAP', 'acetaminophen', 'Acetaminophen (APAP', 'placebo']","['plasma APAP concentration and urine metabolites (glucuronide, sulfate, cysteine, and mercapturate); liver function monitoring', 'clinical signs of liver injury', 'ALT elevations', 'serum alanine aminotransferase (ALT) elevations', 'plasma APAP concentrations and ALT levels', 'frequency of homozygotes and compound heterozygotes', 'ALT level', 'Urinary excretion of APAP mercapturate', 'elevated ALT levels']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0019425', 'cui_str': 'Heterozygote'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C1443982', 'cui_str': 'ALT (SGPT) level raised'}]",242.0,0.0368139,"Urinary excretion of APAP mercapturate was higher in susceptible than in tolerant individuals (P = 0.018, Wilcoxon or Kruskal-Wallis test).","[{'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Maeda', 'Affiliation': 'Kitasato University Graduate School of Medical Sciences, Kanagawa, Japan; Department of Pharmacy, Kitasato University Hospital, Kanagawa, Japan. Electronic address: m-maeda@kitasato-u.ac.jp.'}, {'ForeName': 'Rieko', 'Initials': 'R', 'LastName': 'Tanaka', 'Affiliation': 'Kitasato Clinical Research Center, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Aso', 'Affiliation': 'Soleil Kawasaki Medical Center for the Handicapped, Kanagawa, Japan.'}, {'ForeName': 'Yasutoshi', 'Initials': 'Y', 'LastName': 'Sakamoto', 'Affiliation': 'Translational Research Support Section, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Ildae', 'Initials': 'I', 'LastName': 'Song', 'Affiliation': 'Kitasato Clinical Research Center, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Michiru', 'Initials': 'M', 'LastName': 'Ochiai', 'Affiliation': 'Kitasato University Graduate School of Medical Sciences, Kanagawa, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Division of Medicinal Safety Science, National Institute of Health Sciences, Kanagawa, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Maekawa', 'Affiliation': 'Division of Medicinal Safety Science, National Institute of Health Sciences, Kanagawa, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Arakawa', 'Affiliation': 'Division of Medicinal Safety Science, National Institute of Health Sciences, Kanagawa, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohno', 'Affiliation': 'Kihara Memorial Yokohama Foundation for the Advancement of Life Sciences, Kanagawa, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Kumagai', 'Affiliation': 'Kitasato Clinical Research Center, Kitasato University School of Medicine, Kanagawa, Japan.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.05.003']
1442,32684465,Short communication: Effect of purple corn pigment on change of anthocyanin composition and unsaturated fatty acids during milk storage.,"Unsaturated fatty acids (UFA) in milk give rise to radicals and lead to lipid oxidation during storage, reducing the commercial value of milk. The objective of this study was to observe the effect of anthocyanins from purple corn pigment on the oxidation of UFA in milk. Milk samples were randomly divided into 2 groups: (1) the control (without purple corn pigment) and (2) treatment (0.3% purple corn pigment), using a completely randomized design. The milk samples were placed into plastic tubes and stored at 4°C for a period of 0, 1, 3, and 7 d. Individual anthocyanin composition and UFA were detected by HPLC-mass spectrometry and gas chromatography-mass spectrometry, respectively. The results indicated that pelargonidin (0.258 vs. 0.054 µg/mL), cyanidin (5.550 vs. 1.808 µg/mL), petunidin (0.464 vs. 0.107 µg/mL), delphinidin (2.061 vs. 0.123 µg/mL), and total anthocyanin (8.332 vs. 2.091 µg/mL) significantly decreased in response to increasing storage day. Of interest, purple corn pigment had a significant effect on most of the UFA (C14:1n-5, C16:1n-7, C18:1n-9, C18:2n-6, C18:3n-3, C18:3n-6, C20:2n-6, C20:3n-3, and C20:4n-6), except for C17:1n-7 and C20:3n-6. Specifically, various stronger positive correlations were noted for anthocyanin composition and UFA (pelargonidin and petunidin with C14:1n-5, C17:1n-7, C18:2n-6, C20:2n-6, C20:3n-3, and C20:4n-6; and cyanidin and total anthocyanins with C14:1n-5, C16:1n-7, C17:1n-7). Collectively, the current study suggested that the addition of anthocyanins from purple corn pigment had the potential to maintain UFA concentrations in milk during the storage period.",2020,"The results indicated that pelargonidin (0.258 vs. 0.054 µg/mL), cyanidin (5.550 vs. 1.808 µg/mL), petunidin (0.464 vs. 0.107 µg/mL), delphinidin (2.061 vs. 0.123 µg/mL), and total anthocyanin (8.332 vs. 2.091 µg/mL) significantly decreased in response to increasing storage day.",[],"['control (without purple corn pigment) and (2) treatment (0.3% purple corn pigment', 'purple corn pigment', 'anthocyanins from purple corn pigment', 'Unsaturated fatty acids (UFA', 'pelargonidin']","['delphinidin', 'total anthocyanin', 'cyanidin', 'anthocyanin composition and unsaturated fatty acids', 'anthocyanin composition and UFA (pelargonidin and petunidin with C14:1n-5, C17:1n-7, C18:2n-6, C20:2n-6, C20:3n-3, and C20:4n-6; and cyanidin and total anthocyanins with C14:1n-5, C16:1n-7, C17:1n-7']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439542', 'cui_str': 'Purple'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0083970', 'cui_str': 'pelargonidin'}]","[{'cui': 'C0057304', 'cui_str': 'delphinidin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0056650', 'cui_str': 'cyanidin'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0083970', 'cui_str': 'pelargonidin'}, {'cui': 'C1175797', 'cui_str': 'petunidin'}]",,0.0240595,"The results indicated that pelargonidin (0.258 vs. 0.054 µg/mL), cyanidin (5.550 vs. 1.808 µg/mL), petunidin (0.464 vs. 0.107 µg/mL), delphinidin (2.061 vs. 0.123 µg/mL), and total anthocyanin (8.332 vs. 2.091 µg/mL) significantly decreased in response to increasing storage day.","[{'ForeName': 'X Z', 'Initials': 'XZ', 'LastName': 'Tian', 'Affiliation': 'College of Animal Science, Guizhou University, Guiyang, 550025, China; Institute of Animal Nutrition and Feed Science, Guizhou University, Guiyang, 550025, China. Electronic address: tianxingzhou@yeah.net.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'College of Animal Science, Guizhou University, Guiyang, 550025, China; Institute of Animal Nutrition and Feed Science, Guizhou University, Guiyang, 550025, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Paengkoum', 'Affiliation': 'School of Animal Technology and Innovation, Suranaree University of Technology, Nakhon Ratchasima, 30000, Thailand.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Paengkoum', 'Affiliation': 'Program in Agriculture, Faculty of Science and Technology, Nakhon Ratchasima Rajabhat University, Muang, Nakhon Ratchasima, 30000, Thailand.'}]",Journal of dairy science,['10.3168/jds.2020-18409']
1443,32635181,Impact of Glutathione and Vitamin B-6 in Cirrhosis Patients: A Randomized Controlled Trial and Follow-Up Study.,"Vitamin B-6 and glutathione (GSH) are antioxidant nutrients, and inadequate vitamin B-6 may indirectly limit glutathione synthesis and further affect the antioxidant capacities. Since liver cirrhosis is often associated with increased oxidative stress and decreased antioxidant capacities, we conducted a double-blind randomized controlled trial to assess the antioxidative effect of vitamin B-6, GSH, or vitamin B-6/GSH combined supplementation in cirrhotic patients. We followed patients after the end of supplementation to evaluate the association of vitamin B-6 and GSH with disease severity. In total, 61 liver cirrhosis patients were randomly assigned to placebo, vitamin B-6 (50 mg pyridoxine/d), GSH (500 mg/d), or B-6 + GSH groups for 12 weeks. After the end of supplementation, the condition of patient's disease severity was followed until the end of the study. Neither vitamin B-6 nor GSH supplementation had significant effects on indicators of oxidative stress and antioxidant capacities. The median follow-up time was 984 d, and 21 patients were lost to follow-up. High levels of GSH, a high GSH/oxidized GSH ratio, and high GSH-St activity at baseline (Week 0) had a significant effect on low Child-Turcotte-Pugh scores at Week 0, the end of supplementation (Week 12), and the end of follow-up in all patients after adjusting for potential confounders. Although the decreased GSH and its related enzyme activity were associated with the severity of liver cirrhosis, vitamin B-6 and GSH supplementation had no significant effect on reducing oxidative stress and increasing antioxidant capacities.",2020,Neither vitamin B-6 nor GSH supplementation had significant effects on indicators of oxidative stress and antioxidant capacities.,"['Cirrhosis Patients', '61 liver cirrhosis patients', 'cirrhotic patients']","['Vitamin B-6 and glutathione (GSH', 'vitamin B-6, GSH, or vitamin B-6/GSH combined supplementation', 'Glutathione and Vitamin B-6', 'B-6 + GSH', 'placebo, vitamin B-6 (50 mg pyridoxine/d), GSH', 'vitamin B-6 nor GSH supplementation']","['low Child-Turcotte-Pugh scores', 'oxidative stress and antioxidant capacities', 'High levels of GSH, a high GSH/oxidized GSH ratio, and high GSH-St activity', 'oxidative stress and increasing antioxidant capacities']","[{'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439686', 'cui_str': 'Cirrhotic'}]","[{'cui': 'C0087162', 'cui_str': 'Vitamin B6'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0626128', 'cui_str': ""5'-O-(6-O-malonylglucopyranosyl)pyridoxine""}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3854424', 'cui_str': 'Child-Pugh-Turcotte score'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",61.0,0.342681,Neither vitamin B-6 nor GSH supplementation had significant effects on indicators of oxidative stress and antioxidant capacities.,"[{'ForeName': 'Chia-Yu', 'Initials': 'CY', 'LastName': 'Lai', 'Affiliation': 'Division of General Surgery, Department of Surgery, Taichung Veterans General Hospital, Taichung 40705, Taiwan.'}, {'ForeName': 'Shao-Bin', 'Initials': 'SB', 'LastName': 'Cheng', 'Affiliation': 'Division of General Surgery, Department of Surgery, Taichung Veterans General Hospital, Taichung 40705, Taiwan.'}, {'ForeName': 'Teng-Yu', 'Initials': 'TY', 'LastName': 'Lee', 'Affiliation': 'School of Medicine, Chung Shan Medical University, Taichung 40201, Taiwan.'}, {'ForeName': 'Yung-Fang', 'Initials': 'YF', 'LastName': 'Hsiao', 'Affiliation': 'Graduate Program in Nutrition, Department of Nutrition, Chung Shan Medical University, Taichung 40201, Taiwan.'}, {'ForeName': 'Hsiao-Tien', 'Initials': 'HT', 'LastName': 'Liu', 'Affiliation': 'Division of General Surgery, Department of Surgery, Taichung Veterans General Hospital, Taichung 40705, Taiwan.'}, {'ForeName': 'Yi-Chia', 'Initials': 'YC', 'LastName': 'Huang', 'Affiliation': 'Department of Nutrition, Chung Shan Medical University, Taichung 40201, Taiwan.'}]",Nutrients,['10.3390/nu12071978']
1444,32641226,Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction: Rationale and Design of the LIFE Trial.,"The PARADIGM-HF (Prospective Comparison of Angiotensin II Receptor Blocker Neprilysin Inhibitor With Angiotensin-Converting Enzyme Inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure) trial reported that sacubitril/valsartan (S/V), an angiotensin receptor-neprilysin inhibitor, significantly reduced mortality and heart failure (HF) hospitalization in HF patients with a reduced ejection fraction (HFrEF). However, fewer than 1% of patients in the PARADIGM-HF study had New York Heart Association (NYHA) functional class IV symptoms. Accordingly, data that informed the use of S/V among patients with advanced HF were limited. The LIFE (LCZ696 in Hospitalized Advanced Heart Failure) study was a 24-week prospective, multicenter, double-blinded, double-dummy, active comparator trial that compared the safety, efficacy, and tolerability of S/V with those of valsartan in patients with advanced HFrEF. The trial planned to randomize 400 patients ≥18 years of age with advanced HF, defined as an EF ≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP] ≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP] ≥800 pg/ml), and ≥1 objective finding of advanced HF. Following a 3- to 7-day open label run-in period with S/V (24 mg/26 mg twice daily), patients were randomized 1:1 to S/V titrated to 97 mg/103 mg twice daily versus 160 mg of V twice daily. The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24. Secondary and tertiary endpoints included clinical outcomes and safety and tolerability. Because of the COVID-19 pandemic, enrollment in the LIFE trial was stopped prematurely to ensure patient safety and data integrity. The primary analysis consists of the first 335 randomized patients whose clinical follow-up examination results were not severely impacted by COVID-19. (Entresto [LCZ696] in Advanced Heart Failure [LIFE STUDY] [HFN-LIFE]; NCT02816736).",2020,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"['400 patients\xa0≥18 years of age with advanced HF, defined as an EF\xa0≤35%, New York Heart Association functional class IV symptoms, elevated natriuretic peptide concentration (B-type natriuretic peptide [BNP]\xa0≥250 pg/ml or N-terminal pro-B-type natriuretic peptide [NT-proBNP]\xa0≥800 pg/ml), and\xa0≥1 objective finding of advanced HF', 'patients with advanced HF', 'Failure With Reduced Ejection Fraction', 'Heart\xa0Failure', 'Advanced Heart\xa0Failure [LIFE STUDY', 'HF patients with a reduced ejection fraction (HFrEF', 'Advanced Heart', 'patients with advanced HFrEF']","['Entresto [LCZ696', 'valsartan', 'Angiotensin II Receptor Blocker Neprilysin Inhibitor', 'Angiotensin-Converting Enzyme Inhibitor', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'LIFE (LCZ696']","['mortality and heart failure (HF) hospitalization', 'proportional change from baseline in the area under the curve for NT-proBNP levels', 'Global Mortality and Morbidity', 'safety, efficacy, and tolerability', 'clinical outcomes and safety and tolerability']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441888', 'cui_str': 'Class 4'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1144709', 'cui_str': 'Natriuretic Peptide Hormones'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C4033616', 'cui_str': 'Entresto'}, {'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C4760695', 'cui_str': 'Neprilysin inhibitor'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",335.0,0.331951,The primary endpoint was the proportional change from baseline in the area under the curve for NT-proBNP levels measured through week 24.,"[{'ForeName': 'Douglas L', 'Initials': 'DL', 'LastName': 'Mann', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri. Electronic address: dmann@wustl.edu.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Givertz', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Vader', 'Affiliation': 'Department of Medicine, Washington University, St. Louis, Missouri.'}, {'ForeName': 'Randall C', 'Initials': 'RC', 'LastName': 'Starling', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Ambrosy', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, Virginia.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'McNulty', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Claudius', 'Initials': 'C', 'LastName': 'Mahr', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, Washington.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gregory D', 'Initials': 'GD', 'LastName': 'Lewis', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Selma F', 'Initials': 'SF', 'LastName': 'Mohammed', 'Affiliation': 'MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Nisha A', 'Initials': 'NA', 'LastName': 'Gilotra', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eiran Z', 'Initials': 'EZ', 'LastName': 'Gorodeski', 'Affiliation': 'Department of Medicine, Harrington Heart and Vascular Center, Case Western Reserve University School of Medicine, Cleveland, Ohio.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Desvigne-Nickens', 'Affiliation': 'Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Baltimore, Maryland.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, Duke University, Durham, North Carolina; Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2020.05.005']
1445,32643326,Evaluation of the mechanical properties and clinical efficacy of biphasic calcium phosphate-added collagen membrane in ridge preservation.,"PURPOSE


This study aimed to evaluate the biocompatibility and the mechanical properties of ultraviolet (UV) cross-linked and biphasic calcium phosphate (BCP)-added collagen membranes and to compare the clinical results of ridge preservation to those obtained using chemically cross-linked collagen membranes.
METHODS


The study comprised an  in vitro  test and a clinical trial for membrane evaluation. BCP-added collagen membranes with UV cross-linking were prepared. In the  in vitro  test, scanning electron microscopy, a collagenase assay, and a tensile strength test were performed. The clinical trial involved 14 patients undergoing a ridge preservation procedure. All participants were randomly divided into the test group, which received UV cross-linked membranes (n=7), and the control group, which received chemically cross-linked membranes (n=7). BCP bone substitutes were used for both the test group and the control group. Cone-beam computed tomography (CBCT) scans were performed and alginate impressions were taken 1 week and 3 months after surgery. The casts were scanned via an optical scanner to measure the volumetric changes. The results were analyzed using the nonparametric Mann-Whitney  U  test.
RESULTS


The fastest degradation rate was found in the collagen membranes without the addition of BCP. The highest enzyme resistance and the highest tensile strength were found when the collagen-to-BCP ratio was 1:1. There was no significant difference in dimensional changes in the 3-dimensional modeling or CBCT scans between the test and control groups in the clinical trial ( P >0.05).
CONCLUSIONS


The addition of BCP and UV cross-linking improved the biocompatibility and the mechanical strength of the membranes. Within the limits of the clinical trial, the sites grafted using BCP in combination with UV cross-linked and BCP-added collagen membranes (test group) did not show any statistically significant difference in terms of dimensional change compared with the control group.",2020,"There was no significant difference in dimensional changes in the 3-dimensional modeling or CBCT scans between the test and control groups in the clinical trial ( P >0.05).
",['14 patients undergoing a ridge preservation procedure'],"['Cone-beam computed tomography (CBCT) scans', 'UV cross-linked membranes (n=7), and the control group, which received chemically cross-linked membranes', 'ultraviolet (UV) cross-linked and biphasic calcium phosphate (BCP)-added collagen membranes', 'biphasic calcium phosphate-added collagen membrane']","['dimensional change', 'highest enzyme resistance and the highest tensile strength', 'fastest degradation rate', '3-dimensional modeling or CBCT scans', 'dimensional changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0210087', 'cui_str': 'hydroxyapatite-beta tricalcium phosphate'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1540845', 'cui_str': 'Tensile strength'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]",14.0,0.0258414,"There was no significant difference in dimensional changes in the 3-dimensional modeling or CBCT scans between the test and control groups in the clinical trial ( P >0.05).
","[{'ForeName': 'Jung Tae', 'Initials': 'JT', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontics, One-Stop Specialty Center, Seoul National University Dental Hospital, Seoul, Korea.'}, {'ForeName': 'Yoonsub', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontology, Dental Research Institute, Seoul National University School of Dentistry, Seoul, Korea.'}, {'ForeName': 'Dajung', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontology, Dental Research Institute, Seoul National University School of Dentistry, Seoul, Korea.'}, {'ForeName': 'Yusang', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Department of Bio Team, Implant Research Institute, Dentis Co., Ltd., Daegu, Korea.'}, {'ForeName': 'Jinyoung', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Bio Team, Implant Research Institute, Dentis Co., Ltd., Daegu, Korea.'}, {'ForeName': 'Sungtae', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Periodontology, Dental Research Institute, Seoul National University School of Dentistry, Seoul, Korea. kst72@snu.ac.kr.'}]",Journal of periodontal & implant science,['10.5051/jpis.2001080054']
1446,32602616,Safety and Efficacy of Budesonide for Liver Transplant Immune Suppression: Results of a Pilot Phase 2a Trial.,"Despite adverse effects like hyperglycemia, new-onset diabetes after transplant (NODAT), and infectious complications, corticosteroid use remains an important part of liver transplantation (LT) immune suppression. Budesonide, a synthetic corticosteroid, undergoes extensive first-pass hepatic metabolism with only 10% systemic bioavailability, providing an opportunity for an improved toxicity-therapeutic ratio. Although effective in the treatment of autoimmune hepatitis, the effects of budesonide for LT immune suppression are unknown. We conducted a single-center phase 2a trial to study the safety and efficacy of budesonide immunosuppressive therapy. From July 2017 to November 2018, 20 patients undergoing a first LT received budesonide tapering doses (from 9 to 3 mg) for 12 weeks. Patients were compared with matched control patients who received prednisone from the same time period. Additionally, both groups received calcineurin inhibitors and mycophenolate mofetil. Outcome measures at week 24 included rates of biopsy-proven acute cellular rejection (ACR), NODAT (hemoglobin A1c >6.4%), and infectious complications. In the budesonide arm, 1 patient developed ACR at week 5 and was removed from the study. Another patient stopped the study drug at week 8 due to persistent nausea. Rates of ACR were similar between the budesonide and control groups (5% versus 5%, P = 1.00). Three patients in the control group developed NODAT versus none in the budesonide group (15% versus 0%; P = 0.23). There were 6 infections in the control group compared with none in the budesonide group (30% versus 0; P = 0.02). These pilot data suggest that budesonide has the potential to be a safe and effective alternative to prednisone for LT immune suppression while reducing steroid-induced infections and NODAT. Randomized controlled trials are required to validate these findings.",2020,"Rates of ACR were similar between budesonide and control groups (5% vs 5%, p=1.00).","['Liver Transplant Immune Suppression', 'From July 2017 to November 2018, twenty subjects undergoing first LT received']","['prednisone', 'Budesonide', 'budesonide immunosuppressive therapy', 'budesonide', 'calcineurin inhibitors and mycophenolate']","['rates of biopsy proven Acute Cellular Rejection (ACR), NODAT (Glycated Hemoglobin > 6.4) and infectious complications', 'Safety and Efficacy', 'safety and efficacy', 'toxicity-therapeutic ratio', 'Rates of ACR']","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}]","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0877453', 'cui_str': 'Acute cellular rejection'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0678793', 'cui_str': 'Therapeutic Index'}]",20.0,0.0575914,"Rates of ACR were similar between budesonide and control groups (5% vs 5%, p=1.00).","[{'ForeName': 'Khurram', 'Initials': 'K', 'LastName': 'Bari', 'Affiliation': 'Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Shimul A', 'Initials': 'SA', 'LastName': 'Shah', 'Affiliation': 'Division of, Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Tiffany E', 'Initials': 'TE', 'LastName': 'Kaiser', 'Affiliation': 'Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Cohen', 'Affiliation': 'Transplant Surgery, Department of Surgery, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Anwar', 'Affiliation': 'Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kleesattel', 'Affiliation': 'Department of Internal Medicine, University of Cincinnati, Cincinnati, OH.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Sherman', 'Affiliation': 'Divisions of, Division of, Digestive Diseases, University of Cincinnati, Cincinnati, OH.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25837']
1447,32600260,Promoting routine syphilis screening among men who have sex with men in China: study protocol for a randomised controlled trial of syphilis self-testing and lottery incentive.,"BACKGROUND


Men who have sex with men (MSM) bear a high burden of syphilis infection. Expanding syphilis testing to improve timely diagnosis and treatment is critical to improve syphilis control. However, syphilis testing rates remain low among MSM, particularly in low- and middle-income countries. We describe the protocol for a randomised controlled trial (RCT) to assess whether provision of syphilis self-testing services can increase the uptake of syphilis testing among MSM in China.
METHODS


Four hundred forty-four high-risk MSM will be recruited online and randomized in a 1:1:1 ratio to (1) standard syphilis self-testing arm; (2) a self-testing arm program enhanced with crowdsourcing and a lottery-based incentive, and (3) a standard of care (control). Self-testing services include a free syphilis self-test kit through the mail at monthly intervals. Participants in the lottery incentive arm will additionally receive health promotion materials generated from an open crowdsourcing contest and be given a lottery draw with a 10% chance to win 100 RMB (approximately 15 US Dollars) upon confirmed completion of syphilis testing. Syphilis self-test kits have step-by-step instructions and an instructional video. This is a non-blinded, open-label, parallel RCT. Participants in each arm will be followed-up at three and 6 months through WeChat (a social media app like Facebook messenger). Confirmation of syphilis self-test use will be determined by requiring participants to submit a photo of the used test kit to study staff via secure data messaging. Both self-testing and facility-based testing will be ascertained by sending a secure photographic image of the completed kit through an existing digital platform. The primary outcome is the proportion of participants who tested for syphilis in the past 3 months.
DISCUSSION


Findings from this study will provide much needed insight on the impact of syphilis self-testing on promoting routine syphilis screening among MSM. The findings will also contribute to our understanding of the safety, effectiveness and acceptability of syphilis self-testing. These findings will have important implications for self-testing policy, both in China and internationally.
TRIAL REGISTRATION


ChiCTR1900022409 (10 April, 2019).",2020,Participants in each arm will be followed-up at three and 6 months through WeChat (a social media app like Facebook messenger).,"['Four hundred forty-four high-risk MSM will be recruited online and randomized in a 1:1:1 ratio to (1', 'men who have sex with men in China', 'MSM in China', 'Men who have sex with men (MSM']","['lottery incentive arm will additionally receive health promotion materials generated from an open crowdsourcing contest and be given a lottery draw with a 10% chance to win 100 RMB', 'standard syphilis self-testing arm; (2) a self-testing arm program enhanced with crowdsourcing and a lottery-based incentive, and (3) a standard of care (control']",['proportion of participants who tested for syphilis in the past 3 months'],"[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C3494386', 'cui_str': 'Crowd Sourcing'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",444.0,0.0534159,Participants in each arm will be followed-up at three and 6 months through WeChat (a social media app like Facebook messenger).,"[{'ForeName': 'Weibin', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China. wangcheng090705@gmail.com.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Ong', 'Affiliation': 'Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': 'Division of Community Health and Research, Eastern Virginia Medical School, Norfolk, Virginia, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marks', 'Affiliation': 'Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'M Kumi', 'Initials': 'MK', 'LastName': 'Smith', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota Twin Cities, Minneapolis, USA.'}, {'ForeName': 'Changchang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Peizhen', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, Guangdong, China.'}]",BMC infectious diseases,['10.1186/s12879-020-05188-z']
1448,32608554,Effects of mirror neuron system-based training on rehabilitation of stroke patients.,"OBJECTIVE


To investigate the clinical effects of the mirror neuron system (MNS)-based training on upper extremity motor function and cognitive function in stroke patients.
METHODS


Sixty stroke patients (time from stroke onset 3-9 months) with upper extremity paresis (Brunnstrom stage II-IV) and cognitive impairment (MoCA score ≥ 15) were enrolled in this study. Patients were randomly allocated into MNS treatment group (N = 30) and control group (N = 30). Both groups underwent regular training for upper extremity motor function and cognitive function, and the MNS group was trained with a therapeutic apparatus named mirror neuron system training (MNST) including different levels of action observation training (AOT). Training lasted 20 min/day, 5 days/week for 8 weeks. MoCA, reaction time, and Wisconsin Card Sorting Test (WCST) were assessed at baseline and 8 weeks after training. Furthermore, Fugl-Meyer assessment (FMA) and Modified Barthel index (MBI) were adopted to evaluated upper extremity motor function and daily life ability.
RESULTS


After 8 consecutive weeks' training, both groups showed significant improvements on the upper extremity motor function, cognitive function, and daily life ability score after training (p < .05). The MNS group showed significantly improved upper extremity motor function and cognitive function (p < .05) compared with control group.
CONCLUSIONS


Combining MNS-based and conventional training can improve upper extremity motor function and cognitive function in stroke patients.",2020,"The MNS group showed significantly improved upper extremity motor function and cognitive function (p < .05) compared with control group.
","['stroke patients', 'Sixty stroke patients (time from stroke onset 3-9\xa0months) with upper extremity paresis (Brunnstrom stage II-IV) and cognitive impairment']","['mirror neuron system-based training', 'regular training', 'MNS group was trained with a therapeutic apparatus named mirror neuron system training (MNST) including different levels of action observation training (AOT', 'Combining MNS-based and conventional training', 'MNS', 'mirror neuron system (MNS)-based training']","['Furthermore, Fugl-Meyer assessment (FMA) and Modified Barthel index (MBI', 'upper extremity motor function and cognitive function', 'upper extremity motor function, cognitive function, and daily life ability score', 'MoCA, reaction time, and Wisconsin Card Sorting Test (WCST']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C3178760', 'cui_str': 'Mirror Neurons'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0451592', 'cui_str': 'Wisconsin card sorting test'}]",60.0,0.0126903,"The MNS group showed significantly improved upper extremity motor function and cognitive function (p < .05) compared with control group.
","[{'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Mao', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Ni', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Shan', 'Affiliation': 'School of Rehabilitation Science and Institute of Rehabilitation Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}]",Brain and behavior,['10.1002/brb3.1729']
1449,32603714,Deterioration of Nighttime Respiratory Mechanics in COPD: Impact of Bronchodilator Therapy.,"BACKGROUND


COPD is associated with nighttime respiratory symptoms, poor sleep quality, and increased risk of nocturnal death. Overnight deterioration of inspiratory capacity (IC) and FEV 1  have been documented previously. However, the precise nature of this deterioration and mechanisms by which evening bronchodilation may mitigate this occurrence have not been studied.
RESEARCH QUESTION


What is the effect of evening dosing of dual, long-acting bronchodilation on detailed nocturnal respiratory mechanics and inspiratory neural drive (IND)?
STUDY DESIGN AND METHODS


A double-blind, randomized, placebo-controlled crossover study assessed the effects of evening long-acting bronchodilation (aclidinium bromide/formoterol fumarate dihydrate: 400/12 μg) or placebo on morning trough IC (12 h after the dose; primary outcome) and serial overnight measurements of spirometry, dynamic respiratory mechanics, and IND (secondary outcomes). Twenty participants with COPD (moderate/severe airway obstruction and lung hyperinflation) underwent serial measurements of IC, spirometry, breathing pattern, esophageal and transdiaphragmatic pressures, and diaphragm electromyography (maximum diaphragmatic electromyography percent; IND) at 6 time points from 0 to 12 h after the dose and compared with sleeping IND.
RESULTS


Compared with placebo, evening bronchodilation was not associated with increased morning trough IC 12 h after the dose (P = .48); however, nadir IC (lowest IC, independent of time), peak IC, area under the curve for 12 h after the dose, and IC for 10 h after the dose were improved (P < .05). During placebo, total airways resistance, lung hyperinflation, IND, and tidal esophageal and transdiaphragmatic pressure swings all increased significantly overnight compared with baseline evening values; however, each of these parameters improved with bronchodilation treatment (P < .05) with no change in ventilation or breathing pattern.
INTERPRETATION


Respiratory mechanics significantly deteriorated at night during placebo. Although the morning trough IC was unchanged, evening bronchodilation treatment was associated consistently with sustained overnight improvements in dynamic respiratory mechanics and inspiratory neural drive compared with placebo CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02429765.",2020,"While morning trough IC was unchanged, evening bronchodilator treatment was consistently associated with sustained overnight improvements in dynamic respiratory mechanics and inspiratory neural drive compared with placebo.","['Chronic Obstructive Pulmonary Disease (COPD', '20 participants with COPD (moderate/severe airway obstruction and lung hyperinflation', 'Chronic Obstructive Pulmonary Disease']","['evening long-acting bronchodilators (BD; aclidinium bromide/formoterol fumarate dihydrate', 'placebo (PL', 'dual, long-acting bronchodilators', 'placebo']","['serial overnight measurements of spirometry, dynamic respiratory mechanics and IND (secondary outcomes', 'dynamic respiratory mechanics and inspiratory neural drive', 'morning trough IC', 'Overnight deterioration of inspiratory capacity (IC) and forced expiratory volume', 'nadir IC (lowest IC, independent of time), peak IC, area under the curve', 'IC, spirometry, breathing pattern, esophageal and transdiaphragmatic pressures and diaphragm electromyography (EMGdi %max ; IND', 'total airways resistance, lung hyperinflation, IND, and tidal esophageal and transdiaphragmatic pressure swings', 'detailed nocturnal respiratory mechanics and inspiratory neural drive (IND']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001883', 'cui_str': 'Respiratory obstruction'}, {'cui': 'C1167782', 'cui_str': 'Lung hyperinflation'}]","[{'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C2699758', 'cui_str': 'aclidinium bromide'}, {'cui': 'C1579393', 'cui_str': 'Formoterol fumarate dihydrate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205504', 'cui_str': 'Transdiaphragmatic approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0232024', 'cui_str': 'Total airway resistance'}, {'cui': 'C1167782', 'cui_str': 'Lung hyperinflation'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",20.0,0.596271,"While morning trough IC was unchanged, evening bronchodilator treatment was consistently associated with sustained overnight improvements in dynamic respiratory mechanics and inspiratory neural drive compared with placebo.","[{'ForeName': 'Nicolle J', 'Initials': 'NJ', 'LastName': 'Domnik', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'James', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Scheeren', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'Ayoo', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Taylor', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Di Luch', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Milne', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Sandra G', 'Initials': 'SG', 'LastName': 'Vincent', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Devin B', 'Initials': 'DB', 'LastName': 'Phillips', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Amany F', 'Initials': 'AF', 'LastName': 'Elbehairy', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada; Department of Chest Diseases, Faculty of Medicine, Alexandria University, Alexandria, Egypt.""}, {'ForeName': 'Sophie J', 'Initials': 'SJ', 'LastName': 'Crinion', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada; Division of Respiratory Medicine, Queen's University, Kingston, Canada; Sleep Disorders Laboratory, Kingston Health Sciences Centre, Kingston, Canada.""}, {'ForeName': 'Helen S', 'Initials': 'HS', 'LastName': 'Driver', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada; Division of Respiratory Medicine, Queen's University, Kingston, Canada; Sleep Disorders Laboratory, Kingston Health Sciences Centre, Kingston, Canada.""}, {'ForeName': 'J Alberto', 'Initials': 'JA', 'LastName': 'Neder', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada; Division of Respiratory Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Denis E', 'Initials': 'DE', 'LastName': ""O'Donnell"", 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada; Division of Respiratory Medicine, Queen's University, Kingston, Canada. Electronic address: odonnell@queensu.ca.""}]",Chest,['10.1016/j.chest.2020.06.033']
1450,32603753,Physical fitness and activity changes after a 24-week soccer-based adaptation of the U.S diabetes prevention program intervention in Hispanic men.,"PURPOSE


One third of the U.S. adult population is estimated to have prediabetes. Hispanics have a 50% higher type 2 diabetes (T2DM) death rate compared to non-Hispanic whites, yet low participation in lifestyle change programs, making this subgroup an important target for prevention efforts. The purpose of this study was to determine the effects of an exercise intervention implementing the Center for Disease Control and Prevention National Diabetes Prevention Program (NDPP) plus recreational soccer (RS) in Hispanic men.
METHODS


Overweight and obese Hispanic men, aged 30-57 years with prediabetes at screening were recruited from the community. Trained soccer coaches led 30-min facilitated discussion of the NDPP modules after each RS session, with two weekly sessions delivered over 12 wks, then once a wk until 24 wks. The 1-h RS sessions followed the Football Fitness curriculum structure. Standardized study assessments included objectively measured physical activity via fitness tracker, physical fitness via validated field tests, global positional system soccer specific metrics and behavior change questionnaires. Mixed models assessed the outcomes as a function of time and cohort and incorporated an unstructured covariance structure to examine the difference between baseline, 12 and 24 wks. All analyses were conducted as intent-to-treat and generated using SAS v 9.4.
RESULTS


Hispanic males (n = 41; mean age 41.9 [6.2 SD] years) were obese at baseline (mean BMI 32.7, standard error [0.7]). After 24 wks of the NDPP+RS intervention, there were significant beneficial changes in vertical jump (2.8 [1.3] cm; p = 0.048), agility and lower extremity muscular power (figure 8-run) at 12 wks (-4.7% change; p = 0.001) and 24 wks (-7.2% change; p < 0.0001), predicted VO 2  max (12 wks: 1.9%; p = 0.007; 24 wks 1.0%; p = 0.036), modified push-ups increased 22% (p < 0.0001) at 12 wks and 31% (p < 0.0001) at 24 wks, dynamic sit-ups increased 10% (p = 0.005) at 12 wks and 15% (p < 0.0001) at 24 wks.
CONCLUSION


Among middle-aged Latino men, broad-ranging significant improvements in physical fitness were observed after 24 wks participating in lifestyle education plus RS in a single arm feasibility trial.",2020,"Hispanics have a 50% higher type 2 diabetes (T2DM) death rate compared to non-Hispanic whites, yet low participation in lifestyle change programs, making this subgroup an important target for prevention efforts.","['Hispanic men', 'Overweight and obese Hispanic men, aged 30-57\u202fyears with prediabetes at screening were recruited from the community', 'Hispanic males (n\u202f=\u202f41; mean age 41.9 [6.2 SD] years) were obese at baseline (mean BMI 32.7, standard error [0.7', 'Trained soccer coaches', 'middle-aged Latino men']","['U.S diabetes prevention program intervention', 'exercise intervention implementing the Center for Disease Control and Prevention National Diabetes Prevention Program (NDPP) plus recreational soccer (RS']","['type 2 diabetes (T2DM) death rate', 'agility and lower extremity muscular power', 'dynamic sit-ups', 'physical activity via fitness tracker, physical fitness via validated field tests, global positional system soccer specific metrics and behavior change questionnaires', 'physical fitness', 'modified push-ups', 'beneficial changes in vertical jump', 'Physical fitness and activity changes']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0560837', 'cui_str': 'Does sit up'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3856555', 'cui_str': 'Fitness Trackers'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0285683,"Hispanics have a 50% higher type 2 diabetes (T2DM) death rate compared to non-Hispanic whites, yet low participation in lifestyle change programs, making this subgroup an important target for prevention efforts.","[{'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Frediani', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Bienvenida', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Jianheng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Melinda K', 'Initials': 'MK', 'LastName': 'Higgins', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lobelo', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA. Electronic address: felipelobelo@emory.edu.'}]",Progress in cardiovascular diseases,['10.1016/j.pcad.2020.06.012']
1451,32606899,"Low-Intensity Continuous Ultrasound for the Symptomatic Treatment of Upper Shoulder and Neck Pain: A Randomized, Double-Blind Placebo-Controlled Clinical Trial.","Purpose


Low-intensity continuous ultrasound (LICUS) is an emerging high-dosimetry ultrasound-based therapy for accelerated tissue healing and the treatment of myofascial pain. In this study, LICUS treatment is clinically evaluated for chronic upper neck and shoulder pain in a randomized, multi-site, double-blind, placebo-controlled study.
Patients and Methods


CONSORT guidelines were followed in conducting and reporting the clinical trial. Thirty-three participants with upper trapezius myofascial pain were randomized for treatment with active (n=25) or placebo (n=8) devices. Investigators and subjects were blinded to treatment groups. Participants self-reported pain daily, rating from 0-10 on the numeric rating scale. If pain rating was more significant than or equal to 3, the LICUS (3MHz, 0.132W/cm 2 , 1.3W, 4 hours) was self-applied for total energy dosimetry of 18,720 Joules per treatment. During the 4-week study, daily pain rating was recorded. If LICUS treatment was delivered, pain before, during, and after treatment were recorded as well as the global rate of change (GROC). Independent  t -tests were used to assess change from baseline and differences between treatment groups. ClinicalTrials.gov: NCT02135094.
Results


There was a 100% completion rate for participants enrolled in the study and no significant differences between the groups regarding demographic variables or baseline outcome measures. Participants treated with active therapy observed a significant mean pain reduction from baseline of 2.61 points for active (p<0.001), compared to 1.58 points decrease from baseline for placebo (p=0.087), resulting in a 1.03 points significant decrease in the active group over placebo (p=0.003). The total GROC was significantly higher in the active group at 2.84 points compared to the placebo group at 0.46 points (p<0.001).
Conclusion


Low-intensity continuous ultrasound treatment significantly reduced pain in patients with upper trapezius myofascial pain of the neck and shoulder. LICUS treatment showed a clinically meaningful improvement in the GROC scores for patients. The results from this clinical trial indicate that the LICUS treatment of 18,720 Joules can effectively be used to treat clinical pain related to upper trapezius myofascial pain. Further research could investigate varying dosimetry to improve efficacy and/or reduce the dose.",2020,There was a 100% completion rate for participants enrolled in the study and no significant differences between the groups regarding demographic variables or baseline outcome measures.,"['Upper Shoulder and Neck Pain', 'patients with upper trapezius myofascial pain of the neck and shoulder', 'Thirty-three participants with upper trapezius myofascial pain']","['Placebo', 'Low-intensity continuous ultrasound (LICUS', 'LICUS', 'Low-Intensity Continuous Ultrasound', 'placebo']","['total GROC', 'global rate of change (GROC', 'GROC scores', 'pain', 'pain rating', 'mean pain reduction', 'chronic upper neck and shoulder pain', 'daily pain rating']","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0450358', 'cui_str': '33'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",33.0,0.547509,There was a 100% completion rate for participants enrolled in the study and no significant differences between the groups regarding demographic variables or baseline outcome measures.,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Petterson', 'Affiliation': 'Orthopaedic Foundation, Stamford, CT, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Plancher', 'Affiliation': 'Plancher Orthopaedics & Sports Medicine, New York, NY 10128, USA.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Klyve', 'Affiliation': 'Department of Mathematics, Central Washington University, Ellensburg, WI, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Draper', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Ortiz', 'Affiliation': 'Medical Pain Consultants, Dryden, NY, USA.'}]",Journal of pain research,['10.2147/JPR.S247463']
1452,32684108,Resistance training-induced improvement in exercise tolerance is not dependent on muscle mass gain in post-menopausal women.,"Menopause transition may impair muscle function, decreasing exercise tolerance. The torque-duration relationship (hyperbolic curve) forms a practical framework within which exercise tolerance may be explored. In this regard, resistance training (RT) increases the curvature constant of this relationship (W'). Muscle hypertrophy and strength gains have been suggested as possible mediators of RT-induced improvement in W', however, it is unclear what the main mediator is. Higher-volume RT (HV-RT), beyond that recommended by RT-guidelines (i.e. three sets per exercise), may promote greater hypertrophy, but not higher strength gains. Hence, this study aimed to investigate whether greater hypertrophy in HV-RT maximises W' gain when compared to LVRT in postmenopausal women (PW). Fifty-eight PW were randomised to the control group (CTRL), HV-RT (six sets per exercise) or LV-RT (three sets per exercise). They underwent a 12-week RT program and were assessed for W', thigh lean body mass (TLBM) and maximal isometric voluntary contraction (MIVC). The TLBM gain was higher ( P  < 0.001) in the HV-RT (9.4%) than LV-RT (3.7%). However, both HV-RT and LV-RT similarly increased MIVC (9.7% vs. 16.5%,  P  = 0.063) and W' (26.4% vs. 34.6%  P  = 0.163). Additionally, the changes in W' were associated with the changes in TLBM (31%,  P  = 0.003) and MIVC (52%,  P = <0.001). However, when the changes in TLBM and MIVC were inserted into the predictive model, only the MIVC (33%,  P  = 0.002) was a predictor of W'. Thus, although HV-RT promoted greater hypertrophy than LV-RT, HV-RT does not seem to maximise W' in PW.  Highlights  Resistance training increased lean body mass, muscle strength, and exercise tolerance in postmenopausal women. Higher-volume resistance training maximised muscle mass gains, but not gains in muscle strength and exercise tolerance in postmenopausal women. Only muscle strength gain was associated with increased exercise tolerance. Therefore, the increase in exercise tolerance induced by-RT is related to gain in muscle strength, but not to gain in lean body mass in increase in exercise tolerance induced by-RT is related to gain in muscle strength, but not to gain in lean body mass in postmenopausal women.",2020,The TLBM gain was higher (P < 0.001) in the HV-RT (9.4%) than LV-RT (3.7%).,"['postmenopausal women (PW', 'Fifty-eight PW', 'post-menopausal women']","['resistance training (RT', 'LVRT', 'control group (CTRL), HV-RT (six sets per exercise) or LV-RT']","['thigh lean body mass (TLBM) and maximal isometric voluntary contraction (MIVC', 'MIVC', 'TLBM', 'TLBM gain', 'TLBM and MIVC']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]",58.0,0.0180164,The TLBM gain was higher (P < 0.001) in the HV-RT (9.4%) than LV-RT (3.7%).,"[{'ForeName': 'Gersiel Nascimento', 'Initials': 'GN', 'LastName': 'de Oliveira Júnior', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Minas Gerais, Brazil.'}, {'ForeName': 'Jairo de Freitas Rodrigues', 'Initials': 'JFR', 'LastName': 'de Sousa', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Minas Gerais, Brazil.'}, {'ForeName': 'Marcelo Augusto da Silva', 'Initials': 'MADS', 'LastName': 'Carneiro', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Minas Gerais, Brazil.'}, {'ForeName': 'Fernanda Maria', 'Initials': 'FM', 'LastName': 'Martins', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Minas Gerais, Brazil.'}, {'ForeName': 'Samarita Beraldo', 'Initials': 'SB', 'LastName': 'Santagnello', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Minas Gerais, Brazil.'}, {'ForeName': 'Fábio Lera', 'Initials': 'FL', 'LastName': 'Orsatti', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triangulo Mineiro (UFTM), Minas Gerais, Brazil.'}]",European journal of sport science,['10.1080/17461391.2020.1798511']
1453,32610059,Behavioral economics informed message content in text message reminders to improve cervical screening participation: Two pragmatic randomized controlled trials.,"The objective of the reported research was to assess the impact of text message (SMS) reminders and their content on cervical screening rates. Women invited for cervical screening in Northwest London from February-October 2015 were eligible. 3133 women aged 24-29 (Study 1) were randomized (1, 1) to 'no SMS' (control), or a primary care physician (PCP) endorsed SMS (SMS-PCP). 11,405 women aged 30-64 (Study 2), were randomized (1, 1:1:1:1:1:1) to either: no SMS, an SMS without manipulation (SMS), the SMS-PCP, an SMS with a total or proportionate social norm (SMS-SNT or SMS-SNP), or an SMS with a gain-framed or loss-framed message (SMS-GF and SMS-LF). The primary outcome was participation at 18 weeks. In Study 1 participation was significantly higher in the SMS-PCP arm (31.4%) compared to control (26.4%, aOR, 1.29, 95%CI: 1.09-1·51; p = 0.002). In Study 2 participation was highest in the SMS-PCP (38.4%) and SMS (38.1%) arms compared to control (34.4%), (aOR: 1.19, 95%CI: 1.03-1.38; p = 0.02 and aOR: 1.18, 95%CI: 1.02-1.37; p = 0.03, respectively). The results demonstrate that behavioral SMSs improve cervical screening participation. The message content plays an important role in the impact of SMS. The results from this trial have already been used to designing effective policy for cervical cancer screening. The NHS Cervical Screening Programme started running a London-wide screening SMS campaign which was based on the cervical screening trial described here. According to figures published by Public Health England, after six months attendance increased by 4.8%, which is the equivalent of 13,400 more women being screened at 18 weeks.",2020,"In Study 1 participation was significantly higher in the SMS-PCP arm (31.4%) compared to control (26.4%, aOR, 1.29, 95%CI: 1.09-1·51; p = 0.002).","['3133 women aged 24-29 (Study 1', 'Women invited for cervical screening in Northwest London from February-October 2015 were eligible', '11,405 women aged 30-64 (Study 2']","['behavioral SMSs', ""no SMS' (control), or a primary care physician (PCP) endorsed SMS (SMS-PCP""]","['cervical screening participation', 'SMS-PCP', 'cervical screening rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0795864', 'cui_str': 'Smith-Magenis syndrome'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}]",11405.0,0.199584,"In Study 1 participation was significantly higher in the SMS-PCP arm (31.4%) compared to control (26.4%, aOR, 1.29, 95%CI: 1.09-1·51; p = 0.002).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Huf', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Kerrison', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'King', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chadborn', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London SE1 8UG, UK.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Richmond', 'Affiliation': 'Breast Cancer Now, 5th Floor Ibex House, 42-47 Minories, London EC3N 1DY, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'West of London Breast Screening Service, Imperial College Healthcare NHS Trust, First Floor, Charing Cross Hospital, Fulham Palace Road, London W6 8RF, UK.'}, {'ForeName': 'Ellis', 'Initials': 'E', 'LastName': 'Friedman', 'Affiliation': 'Faculty of Public Health, 4 St Andrews Place, London NW1 4LB, UK.'}, {'ForeName': 'Heema', 'Initials': 'H', 'LastName': 'Shukla', 'Affiliation': 'Global Health Capacity, Unit 4, Vista Place, Coy Pond Business Park Ingworth Road, Poole, BH12 1JY, UK.'}, {'ForeName': 'Fu-Min', 'Initials': 'FM', 'LastName': 'Tseng', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Judah', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery and Cancer, Imperial College London, St Mary's Hospital Campus, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.""}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Warwick Business School, University of Warwick, Scarman Rd, Coventry CV4 7AL, UK. Electronic address: ivo.vlaev@wbs.ac.uk.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106170']
1454,31427720,The impact of complex karyotype on the overall survival of patients with relapsed chronic lymphocytic leukemia treated with idelalisib plus rituximab.,,2020,,['patients with relapsed chronic lymphocytic leukemia treated with'],"['idelalisib plus rituximab', 'complex karyotype']",['overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2698692', 'cui_str': 'idelalisib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0022526', 'cui_str': 'Karyotype determination'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0533494,,"[{'ForeName': 'Karl-Anton', 'Initials': 'KA', 'LastName': 'Kreuzer', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany. karl-anton.kreuzer@uni-koeln.de.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Furman', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department III of Internal Medicine, Ulm University Medical Center, Ulm, Germany.'}, {'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Dubowy', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Yeonhee', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Veerendra', 'Initials': 'V', 'LastName': 'Munugalavadla', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Lilienweiss', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Hans Christian', 'Initials': 'HC', 'LastName': 'Reinhardt', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Cramer', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""St. James's University Hospital, Leeds, UK.""}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'University of California-Irvine, Irvine Chao Family Comprehensive Cancer Center, Orange, CA, USA.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Pettitt', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}]",Leukemia,['10.1038/s41375-019-0533-6']
1455,32615357,Impact of salt substitute and stepwise reduction of salt supply on blood pressure in residents in senior residential facilities: Design and rationale of the DECIDE-Salt trial.,"BACKGROUND


High sodium intake has been considered as the leading dietary risk factor for deaths and disability-adjusted life-years among older adults. High-quality randomized trials to evaluate the effects of practical sodium reduction strategies are needed.
METHODS


The study is a cluster randomized trial with a 2 × 2 factorial design conducted in 48 senior residential facilities in northern China. These facilities are randomly assigned (1:1:1:1) to 1 of 4 groups: stepwise salt supply control (SSSC) in which 5%-10% of the study salt supply in the institutional kitchens will be reduced every 3 months, replacing normal salt with salt substitute (SS); SSSC only; SS only; or neither SSSC nor SS. The interventions last for 2 years with follow-up every 6 months. The primary outcome is the change in systolic blood pressure from baseline to 24 months. Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death.
CURRENT STATUS


The study has recruited and randomized 48 senior residential facilities with 1,606 participants. Mean age at baseline was 71 years, and 76% are male. Both types of salt intervention were initiated in the study facilities between January and April 2018.
CONCLUSION


The study is well placed to define the effects of 2 practical and scalable sodium reduction strategies for blood pressure reduction and will provide important new data about safety of these strategies among older adults in China.",2020,"Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death.
","['Mean age at baseline was 71\u202fyears, and 76% are male', '48 senior residential facilities with 1,606 participants', 'residents in senior residential facilities', 'older adults in China', '48 senior residential facilities in northern China']","['salt substitute and stepwise reduction of salt supply', 'salt intervention', 'stepwise salt supply control (SSSC', 'normal salt with salt substitute (SS); SSSC only; SS only; or neither SSSC nor SS']","['blood pressure', 'change in systolic blood pressure', 'blood pressure reduction', 'incidence of hyperkalemia, hyponatremia, cardiovascular events, and death']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",48.0,0.0400665,"Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death.
","[{'ForeName': 'Aoming', 'Initials': 'A', 'LastName': 'Jin', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Kiang', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Darwin R', 'Initials': 'DR', 'LastName': 'Labarthe', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Xiangxian', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Changzhi Medical College, Shanxi, China.'}, {'ForeName': 'Ruijuan', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Xi'an Jiaotong University, Shaanxi, China.""}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Hohhot Center for Disease Control and Prevention, Hohhot, Inner Mongolia, China.'}, {'ForeName': 'Qianku', 'Initials': 'Q', 'LastName': 'Qiao', 'Affiliation': 'Yangcheng Ophthalmology Hospital, Shanxi, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'China Center for Health Development Studies, Peking University, Beijing, China.'}, {'ForeName': 'Peifen', 'Initials': 'P', 'LastName': 'Duan', 'Affiliation': 'Changzhi Medical College, Shanxi, China.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Xi'an Jiaotong University, Shaanxi, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Hohhot Center for Disease Control and Prevention, Hohhot, Inner Mongolia, China.'}, {'ForeName': 'Lae', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Yangcheng Ophthalmology Hospital, Shanxi, China.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, Australia, Sydney, Australia; The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Junshi', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'National Center for Food Safety Risk Assessment, Beijing, China.'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China; Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing, China. Electronic address: wuyf@bjmu.edu.cn.'}]",American heart journal,['10.1016/j.ahj.2020.05.013']
1456,32615392,The effects of 6 mo of supplementation with probiotics and synbiotics on gut microbiota in the adults with prediabetes: A double blind randomized clinical trial.,"OBJECTIVES


The evidence of 16S rRNA genes in the gut microbiota distinguished a higher Firmicutes-to-Bacteroidetes ratio in individuals who were obese and had diabetes than in a healthy cohort. So, it seems that the modulation of intestinal microbial ecology by pro-/pre-/synbiotics may contribute to the progression and prevention of metabolic diseases. The aim of this study was to assess the effects of probiotics and synbiotic supplementation on the modification of the intestinal microbiome in adults with prediabetes.
METHODS


In a randomized, double-blinded, placebo-controlled clinical trial, 120 patients with prediabetes were randomly assigned to consume 6 g/d of either a placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic for 6 mo. Fecal samples were obtained at baseline and after 6 mo of supplementation. Dietary intake was assessed throughout the study (at baseline and after 3 and 6 mo). Total energy, macronutrients, and dietary fiber were calculated using a dietary program Nutritionist 4. DNA was extracted from fecal samples and the numbers of Clostridium perfringens (the represent of phylum Firmicutes), Bacteroides fragilis (the representative of Bacteroidetes) and Escherichia coli (as universal bacteria) were determined by quantitative real-time polymerase chain reactions (qPCR). The changes in the relative abundance of the two fecal bacteria before and after supplementation were analyzed and compared within and between groups.
RESULTS


There were no significant changes in dietary intake during the study. Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02). Synbiotic had no significant effect on the changes in the bacteria. There were no significant differences between the three groups.
CONCLUSION


The results of this study suggest that manipulation of the human gut microbiome by using probiotics could provide a potential therapeutic approach in the prevention and management of obesity and metabolic disorders such as diabetes.",2020,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","['120 patients with prediabetes', 'adults with prediabetes']","['dietary program', 'probiotics and synbiotic supplementation', 'placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic', 'Synbiotic', 'supplementation with probiotics and synbiotics', 'placebo']","['dietary intake', 'gut microbiota', 'bacteria', 'Total energy, macronutrients, and dietary fiber', 'abundance of the B. fragilis-to-E.coli ratio', 'Dietary intake', 'Fecal samples']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",120.0,0.249584,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","[{'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Kassaian', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: nkassaian@gmal.com.'}, {'ForeName': 'Awat', 'Initials': 'A', 'LastName': 'Feizi', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center and Department of Biostatistics and Epidemiology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: awat_feiz@hlth.mui.ac.ir.'}, {'ForeName': 'Soodabeh', 'Initials': 'S', 'LastName': 'Rostami', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: srostami1876@gmail.com.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Aminorroaya', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: aminorroaya@med.mui.ac.ir.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Yaran', 'Affiliation': 'Nosocomial Infection Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: yaranmajid@yahoo.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Amini', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: M_amini@med.mui.ac.ir.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110854']
1457,32618538,Influence of pre-schooler and parent nutrition education on carotenoid levels of Mexican-heritage children.,"OBJECTIVE


To determine the mediating effect of direct preschool and parent nutrition education on changes in skin carotenoids scores over 2 years in children of Mexican heritage.
DESIGN


In a quasi-experimental, community-based study, two school districts were randomly assigned to either a comparison group (parent workshops unrelated to nutrition) or a childhood obesity prevention intervention group which included nutrition education at family nights for parents and at school for children. Changes in skin carotenoid intensity scores (diffCAROT, year 2015 minus 2013) were measured in children as a proxy for fruit and vegetable consumption using Resonance Raman Spectroscopy.
SETTING


Two rural, low-income, school districts from a county in California's Central Valley.
PARTICIPANTS


316 Mexican heritage families with children aged 3-8 years.
RESULTS


Intervention group children improved over 2 years in skin carotenoid scores relative to comparison group children (diffCAROT mean +1419 (sd 9540) v. -3473 (sd 9272), P = 0·0001). Parent attendance at nutrition education classes partially mediated the intervention effect on diffCAROT (P = 0·02). Controlling for child's age and other covariates, participation in preschool during the study had a significant positive effect on diffCAROT among intervention children compared with controls (P < 0·03), whereas no significant difference by group was observed among those not enrolled in preschool or already enrolled in elementary school.
CONCLUSIONS


Programmes that combine direct parent and preschool nutrition education may be effective in low-income Mexican heritage families to improve children's intake of fruit and vegetables.",2020,"RESULTS


Intervention group children improved over 2 years in skin carotenoid scores relative to comparison group children (diffCAROT mean +1419 (sd 9540) v. -3473 (sd 9272), P = 0·0001).","['316 Mexican heritage families with children aged 3-8 years', ""Two rural, low-income, school districts from a county in California's Central Valley"", 'In a quasi-experimental, community-based study, two school districts', 'children of Mexican heritage', 'Mexican-heritage children']","['direct preschool and parent nutrition education', 'pre-schooler and parent nutrition education', 'comparison group (parent workshops unrelated to nutrition) or a childhood obesity prevention intervention group which included nutrition education at family nights for parents and at school for children']","['skin carotenoid scores', 'skin carotenoid intensity scores', 'skin carotenoids scores']","[{'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.0238306,"RESULTS


Intervention group children improved over 2 years in skin carotenoid scores relative to comparison group children (diffCAROT mean +1419 (sd 9540) v. -3473 (sd 9272), P = 0·0001).","[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'University of California Cooperative Extension, Yolo County, Woodland, CA95695, USA.'}, {'ForeName': 'Lucia L', 'Initials': 'LL', 'LastName': 'Kaiser', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Rosa D', 'Initials': 'RD', 'LastName': 'Manzo', 'Affiliation': 'Health Sciences Research Institute, University of California, Merced, CA, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Aguilera', 'Affiliation': 'Department of Public Health, University of California, Merced, CA, USA.'}, {'ForeName': 'L Karina', 'Initials': 'LK', 'LastName': 'Diaz Rios', 'Affiliation': 'Division of Agriculture and Natural Resources, University of California, Merced, CA, USA.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Macias', 'Affiliation': 'University of California Cooperative Extension, Fresno County, CA, USA.'}]",Public health nutrition,['10.1017/S1368980019004579']
1458,32619619,"A commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis-an open labeled, randomized controlled trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.130852,,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Colorectal Surgery, Changhai Hospital, Second Military Medical University, 200433, Shanghai, China.'}, {'ForeName': 'Zubing', 'Initials': 'Z', 'LastName': 'Mei', 'Affiliation': 'Department of Anorectal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, 201203, Shanghai, China; Anorectal Disease Institute of Shuguang Hospital, 201203, Shanghai, China. Electronic address: herrmayor@126.com.'}, {'ForeName': 'Guixin', 'Initials': 'G', 'LastName': 'Shen', 'Affiliation': 'Department of General Surgery, The Second Affiliated Hospital of Jiaxing University, 314000, Jiaxing, Zhejiang Province, China. Electronic address: jxeysgx1191@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.06.036']
1459,32621874,"Efficacy of vitamin D 3  supplementation for the prevention of pulmonary tuberculosis and mortality in HIV: a randomised, double-blind, placebo-controlled trial.","BACKGROUND


Observational data suggest that low vitamin D status is associated with an increased incidence of pulmonary tuberculosis and mortality among people living with HIV. The primary aims of this study were to assess the effect of vitamin D 3  supplementation on the risk of mortality and incidence of pulmonary tuberculosis among adults initiating antiretroviral therapy (ART).
METHODS


This was a randomised, double-blind, placebo-controlled trial of vitamin D 3  supplementation among adults living with HIV who initiated ART and had serum 25-hydroxyvitamin D concentrations of less than 30 ng/mL at four large HIV care and treatment centres in Dar es Salaam, Tanzania. Patients were excluded if they were younger than 18 years, pregnant at the time of randomisation, or were enrolled in any other clinical trial. Patients were randomly assigned 1:1 to receive either weekly oral 50 000 IU vitamin D 3  supplements (cholecalciferol) for the first month of ART followed by daily 2000 IU vitamin D 3  supplements or a matching weekly and daily placebo regimen. The randomisation list was computer-generated by a non-study statistician with sequence blocks of ten that were stratified by study clinic. Complete allocation concealment was ensured and patients, field team, and investigators were masked to group assignment. The trial follow-up duration was 1 year and the primary efficacy outcomes were death and incident pulmonary tuberculosis. An intention-to-treat analysis was followed for all-cause mortality; participants diagnosed with or receiving treatment for pulmonary tuberculosis at randomisation, or suspected to have tuberculosis at randomisation and who later had that diagnosis confirmed, were excluded from analyses of pulmonary tuberculosis incidence. Safety was assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT01798680, and is completed.
FINDINGS


Between Feb 24, 2014, and Feb 24, 2017, 6250 adults initiating ART had serum 25-hydroxyvitamin D screening, 4000 of whom were enrolled in the trial and followed up for 1 year (follow-up of all participants was completed on March 7, 2018). 2001 patients were randomly assigned to the vitamin D 3  supplementation group, and 1999 to the placebo group. 415 deaths were recorded: 211 in the vitamin D 3  group and 204 in the placebo group. Among all randomly assigned participants, there was no overall effect of vitamin D 3  supplementation on the risk of mortality (hazard ratio [HR] 1·04, 95% CI 0·85-1·25; p=0·73). There was also no difference in the overall incidence of pulmonary tuberculosis between the vitamin D 3  (50 events in 1812 patients analysed) and placebo groups (64 events in 1827 patients; HR 0·78, 0·54-1·13; p=0·19). The vitamin D 3  regimen did not increase the risk of hypercalcaemia (three events in the vitamin D 3  group and two events in the placebo group; relative risk 1·25, 95% CI 0·43-3·66; Fisher's exact p=1·00). 101 hospital admissions were reported in the vitamin D 3  group and 94 in the placebo group (incidence rate ratio 1·06, 95% CI 0·80-1·41; p=0·66).
INTERPRETATION


Additional research is needed before vitamin D 3  supplementation should be considered for implementation in HIV care and treatment programmes for the prevention of pulmonary tuberculosis or mortality.
FUNDING


National Institute of Diabetes and Digestive and Kidney Diseases.",2020,"The vitamin D 3  regimen did not increase the risk of hypercalcaemia (three events in the vitamin D 3  group and two events in the placebo group; relative risk 1·25, 95% CI 0·43-3·66; Fisher's exact p=1·00).","['adults initiating antiretroviral therapy (ART', '6250 adults initiating ART had serum 25-hydroxyvitamin D screening, 4000 of whom were enrolled in the trial and followed up for 1 year (follow-up of all participants was completed on March 7, 2018', '2001 patients', 'pulmonary tuberculosis and mortality in HIV', 'Between Feb 24, 2014, and Feb 24, 2017', 'mortality; participants diagnosed with or receiving treatment for pulmonary tuberculosis at randomisation, or suspected to have tuberculosis at randomisation and who later had that diagnosis confirmed, were excluded from analyses of pulmonary tuberculosis incidence', 'adults living with HIV who initiated ART and had serum 25-hydroxyvitamin D concentrations of less than 30 ng/mL at four large HIV care and treatment centres in Dar es Salaam, Tanzania', 'people living with HIV', 'Patients were excluded if they were younger than 18 years, pregnant at the time of randomisation, or were enrolled in any other clinical trial']","['vitamin D 3  supplementation', 'vitamin D 3  supplements (cholecalciferol', 'placebo']","['Safety', '415 deaths', 'risk of hypercalcaemia', '101 hospital admissions', 'risk of mortality and incidence of pulmonary tuberculosis', 'death and incident pulmonary tuberculosis', 'risk of mortality (hazard ratio [HR', 'overall incidence of pulmonary tuberculosis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022595', 'cui_str': 'Darier disease'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",6250.0,0.791652,"The vitamin D 3  regimen did not increase the risk of hypercalcaemia (three events in the vitamin D 3  group and two events in the placebo group; relative risk 1·25, 95% CI 0·43-3·66; Fisher's exact p=1·00).","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Sudfeld', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA; Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA. Electronic address: csudfeld@hsph.harvard.edu.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Mugusi', 'Affiliation': 'Department of Internal Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Alfa', 'Initials': 'A', 'LastName': 'Muhihi', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': 'Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Tumaini J', 'Initials': 'TJ', 'LastName': 'Nagu', 'Affiliation': 'Department of Internal Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Nzovu', 'Initials': 'N', 'LastName': 'Ulenga', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Biling', 'Initials': 'B', 'LastName': 'Hong', 'Affiliation': 'Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Molin', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA; Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Wafaie W', 'Initials': 'WW', 'LastName': 'Fawzi', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA; Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA; Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30108-9']
1460,32648474,Predictors and Clinical Outcomes of Crossover From Radial to Femoral Access During Primary Percutaneous Coronary Intervention.,"Access site complications are more common with femoral access (FA) than radial access (RA). However, due to the higher rate of failure and crossover, door-to-balloon time (DBT) is prolonged by RA. Records of 3600 patients who underwent primary percutaneous coronary intervention (pPCI) between January 2016 and June 2019 were retrospectively reviewed. A total of 130 patients with crossover from RA to FA were identified and compared with the data of 501 patients who underwent pPCI with successful RA during 2018. Regression analysis was performed to determine the predictors of crossover. Crossover to the femoral approach occurred in 5.9% of our cases. Mean DBT was 17 minutes longer in the crossover group (61 ± 72 minutes vs 78 ± 79 minutes,  P  = .026). Female sex (odds ratio [OR]: 1.8; 95% CI, 0.99-3.46,  P  = .046) and anterior myocardial infarction (AntMI; OR: 0.52; 95% CI, 0.33-0.88,  P  = .007) were independent predictors of crossover. In-hospital mortality rates were significantly higher in the crossover group than in the radial success group (5.4% vs 1.8%,  P  = .020). Crossover to FA due to radial failure is associated with delayed DBT and increased rate of in-hospital mortality. Female sex and AntMI were primary predictors of crossover.",2020,"Mean DBT was 17 minutes longer in the crossover group (61 ± 72 minutes vs 78 ± 79 minutes,  P  = .026).","['3600 patients who underwent primary percutaneous coronary intervention (pPCI) between January 2016 and June 2019 were retrospectively reviewed', '130 patients with crossover from RA to FA were identified and compared with the data of 501 patients who underwent pPCI with successful RA during 2018', 'Female sex (odds ratio ']",['Crossover From Radial to Femoral Access'],"['rate of in-hospital mortality', 'hospital mortality rates', 'anterior myocardial infarction', 'Mean DBT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]","[{'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0340293', 'cui_str': 'Myocardial Infarction, Anterior Wall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0557698', 'cui_str': 'Door'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",130.0,0.0870107,"Mean DBT was 17 minutes longer in the crossover group (61 ± 72 minutes vs 78 ± 79 minutes,  P  = .026).","[{'ForeName': 'Salih', 'Initials': 'S', 'LastName': 'Şahinkuş', 'Affiliation': 'Cardiology Department, 175679Sakarya University Education and Research Hospital, Sakarya, Turkey.'}, {'ForeName': 'Muhammet Necati Murat', 'Initials': 'MNM', 'LastName': 'Aksoy', 'Affiliation': 'Cardiology Department, 175679Sakarya University Education and Research Hospital, Sakarya, Turkey.'}, {'ForeName': 'Ercan', 'Initials': 'E', 'LastName': 'Aydin', 'Affiliation': 'Cardiology Department, Vakfıkebir State Hospital, Trabzon, Turkey.'}]",Angiology,['10.1177/0003319720940128']
1461,32648821,Impacts of prolonged sitting with mild hypercapnia on vascular and autonomic function in healthy recreationally active adults.,"Prolonged sitting, which is known to impair peripheral vascular function, often occurs in spaces (e.g., offices) with mild hypercapnic atmospheres. However, the effects of prolonged sitting in hypercapnic conditions on vascular function are unknown. Therefore, the purpose of this study was to investigate the effects of prolonged sitting in mild hypercapnic conditions on vascular and autonomic function in humans. Twelve healthy young adults participated in two experimental visits that consisted of sitting for 2.5 h in a control condition [normal atmospheric conditions sitting (PSIT)] or a mild hypercapnic condition (HCAP; CO 2  = 1,500 ppm). During each visit, heart rate variability (HRV), blood pressure (BP), pulse wave velocity (PWV), augmentation index (AIx), brachial and popliteal artery flow-mediated dilation (FMD), and near-infrared spectroscopy (NIRS) were assessed before and after prolonged sitting. Sitting significantly decreased AIx in both groups ( P  < 0.05). Brachial and popliteal FMD were reduced with sitting ( P  < 0.05), and the reduction in popliteal FMD was amplified by HCAP ( P  < 0.05). Baseline microvascular oxygenation was decreased following sitting in both groups ( P  < 0.05). However, microvascular reoxygenation upon cuff release was slower only in HCAP ( P  < 0.05). HRV, HR, BP, and PWV did not significantly change with sitting in either group ( P  > 0.05). We conclude that prolonged sitting attenuated both brachial and popliteal endothelial function and was associated with perturbed microcirculation. Additionally, mild hypercapnic conditions further impaired peripheral endothelial and microvascular function. Together, these findings suggest that prolonged sitting is accompanied by a host of deleterious effects on the vasculature, which are exacerbated by mild hypercapnia. NEW & NOTEWORTHY  The results of this study reveal that prolonged sitting attenuates endothelial function and microvascular function. Additionally, prolonged sitting with mild hypercapnia, which is similar to everyday environments, further exacerbates peripheral endothelial function and microvascular function.",2020,Baseline microvascular oxygenation was decreased following sitting in both groups (P<0.05).,"['12 healthy young adults', 'healthy recreationally active adults', 'humans']","['experimental visits which consisted of sitting for 2.5 hours in a control condition (PSIT) or a mild hypercapnic condition (HCAP, CO2=1,500 ppm', 'prolonged sitting with mild hypercapnia']","['reduction in popliteal FMD', 'Prolonged sitting attenuated both brachial and popliteal endothelial function', 'peripheral endothelial and microvascular function', 'Brachial and popliteal FMD', 'HRV, HR, BP, and PWV', 'microvascular reoxygenation upon cuff release', 'vascular and autonomic function', 'Baseline microvascular oxygenation', 'heart rate variability (HRV), blood pressure (BP), pulse wave velocity (PWV), augmentation index (AIx), brachial and popliteal artery flow mediated dilation (FMD), and near infrared spectroscopy (NIRS']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0056451', 'cui_str': 'H-CAP protocol'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032649', 'cui_str': 'Structure of popliteal artery'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}]",12.0,0.0577376,Baseline microvascular oxygenation was decreased following sitting in both groups (P<0.05).,"[{'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Headid', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Pekas', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'TeSean K', 'Initials': 'TK', 'LastName': 'Wooden', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Won-Mok', 'Initials': 'WM', 'LastName': 'Son', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Layec', 'Affiliation': 'Department of Kinesiology, University of Massachusetts, Amherst, Massachusetts.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'Wiess School of Natural Sciences, Rice University, Houston, Texas.'}, {'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska at Omaha, Omaha, Nebraska.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00354.2020']
1462,32651013,Randomized Study of Delayed Cord Clamping of 30 to 60 Seconds in the Larger Infant Born Preterm.,"In a randomized study of infants born preterm (gestational age 28-34 6/7 weeks), we evaluated delayed cord clamping for 30 (n = 50) vs 60 (n = 55) seconds. The primary outcome of initial hematocrit differed by 2.8% (P = .006), being greater with 60 seconds. There were no differences in secondary outcomes and no adverse consequences between groups. These findings should serve as a stimulus to many centers that are reluctant to implement delayed cord clamping in this targeted larger premature population.",2020,"The primary outcome of initial hematocrit differed by 2.8% (P = .006), being greater with 60 seconds.","['Larger Infant Born Preterm', 'infants born preterm (gestational age 28-34 6/7\xa0weeks), we evaluated delayed cord clamping for 30 (n\xa0=\xa050) vs 60 (n\xa0=\xa055) seconds']",['Delayed Cord Clamping'],"['adverse consequences', 'initial hematocrit']","[{'cui': 'C0349482', 'cui_str': 'High birth weight'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0205436', 'cui_str': 'Second'}]","[{'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}]",,0.0611567,"The primary outcome of initial hematocrit differed by 2.8% (P = .006), being greater with 60 seconds.","[{'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Perretta', 'Affiliation': 'Division of Newborn Medicine, Department of Pediatrics, New York Presbyterian-Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Spaight', 'Affiliation': 'Division of Newborn Medicine, Department of Pediatrics, New York Presbyterian-Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Vivien', 'Initials': 'V', 'LastName': 'Yap', 'Affiliation': 'Division of Newborn Medicine, Department of Pediatrics, New York Presbyterian-Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Perlman', 'Affiliation': 'Division of Newborn Medicine, Department of Pediatrics, New York Presbyterian-Weill Cornell Medicine, New York, NY. Electronic address: jmp2007@med.cornell.edu.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.04.058']
1463,32605005,"Effects of Acute Cocoa Supplementation on Postprandial Apolipoproteins, Lipoprotein Subclasses, and Inflammatory Biomarkers in Adults with Type 2 Diabetes after a High-Fat Meal.","Dyslipidemia and inflammation exacerbate postprandial metabolic stress in people with diabetes. Acute dietary supplementation with polyphenols shows promise in improving postprandial metabolic stress in type 2 diabetes (T2D). Cocoa is a rich source of dietary polyphenols with demonstrated cardioprotective effects in adults without diabetes. To date, the acute effects of cocoa on postprandial lipids and inflammation have received little attention in the presence of T2D. This report expands on our earlier observation that polyphenol-rich cocoa, given as a beverage with a fast-food-style, high-fat breakfast, increased postprandial high-density lipoprotein-cholesterol (HDL-C) in adults with T2D. We now test whether polyphenol-rich cocoa modulated postprandial apolipoproteins (Apo-A1, B), non-esterified fatty acids, nuclear magnetic resonance (NMR)-derived lipoprotein subclass profiles, and select biomarkers of inflammation following the same dietary challenge. We found that cocoa decreased NMR-derived concentrations of total very low-density lipoprotein and chylomicron particles and increased the concentration of total HDL particles over the 6-hour postprandial phase. Serum interleukin-18 was decreased by cocoa vs. placebo. Thus, polyphenol-rich cocoa may alleviate postprandial dyslipidemia and inflammation following a high-fat dietary challenge in adults with T2D. The study was registered at clinicaltrials.gov as NCT01886989.",2020,We found that cocoa decreased NMR-derived concentrations of total very low-density lipoprotein and chylomicron particles and increased the concentration of total HDL particles over the 6-hour postprandial phase.,"['people with diabetes', 'Adults with Type 2 Diabetes after a High-Fat Meal', 'adults without diabetes', 'adults with T2D', 'type 2 diabetes (T2D']","['Acute Cocoa Supplementation', 'polyphenol-rich cocoa', 'Cocoa', 'polyphenols', 'cocoa vs. placebo']","['Dyslipidemia and inflammation exacerbate postprandial metabolic stress', 'Serum interleukin-18', 'Postprandial Apolipoproteins, Lipoprotein Subclasses, and Inflammatory Biomarkers', 'concentration of total HDL particles', 'postprandial high-density lipoprotein-cholesterol (HDL-C', 'postprandial metabolic stress']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C2350024', 'cui_str': 'Metabolic Stress'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0445604', 'cui_str': 'Subclass'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]",,0.103555,We found that cocoa decreased NMR-derived concentrations of total very low-density lipoprotein and chylomicron particles and increased the concentration of total HDL particles over the 6-hour postprandial phase.,"[{'ForeName': 'Dustin W', 'Initials': 'DW', 'LastName': 'Davis', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, School of Integrated Health Sciences, University of Nevada, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Rickelle', 'Initials': 'R', 'LastName': 'Tallent', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, School of Integrated Health Sciences, University of Nevada, Las Vegas, NV 89154, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Navalta', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, School of Integrated Health Sciences, University of Nevada, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Salazar', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, School of Integrated Health Sciences, University of Nevada, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Lyons', 'Affiliation': 'Division of Endocrinology, Medical University of South Carolina, Charleston, SC 29245, USA.'}, {'ForeName': 'Arpita', 'Initials': 'A', 'LastName': 'Basu', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, School of Integrated Health Sciences, University of Nevada, Las Vegas, NV 89154, USA.'}]",Nutrients,['10.3390/nu12071902']
1464,32613451,Muscle pain induced by hypertonic saline in the knee extensors decreases single-limb isometric time to task failure.,"PURPOSE


Increased nociceptive activity and the experience of exercise-induced pain (EIP) may contribute to fatigue during endurance exercise. To investigate this, a pain model that produces pain similar to EIP and decouples its relationship to exercise intensity is required. This study (1) compared the quality of pain caused by a hypertonic saline injection into the vastus lateralis in resting and exercise conditions, and (2) investigated whether this pain contributes to changes in time to task failure.
METHODS


On separate days, 18 participants completed a time to task failure at 20% maximal voluntary torque (MVT), a resting hypertonic saline intramuscular injection, and in a further three visits a time to task failure at 10% MVT following injection of isotonic saline, hypertonic saline or a control (no injection).
RESULTS


In a subset of eligible participants (n = 12), the hypertonic saline combined with 10% MVT produced a qualitative experience of pain (assessed by the McGill Pain Questionnaire) that felt similar to EIP. 10% MVT with hypertonic saline significantly elevated pain intensity in the first 20% of the time to task failure and caused a significantly (P < 0.05) shorter time to task failure (448 ± 240 s) compared with the isotonic saline (605 ± 285 s) and control (514 ± 197 s) conditions.
CONCLUSION


These findings demonstrate that hypertonic saline increases the intensity of pain during exercise, which results in a faster occurrence of exercise-induced fatigue. These results provide important evidence supporting pain as a limiting factor in endurance performance.",2020,"10% MVT with hypertonic saline significantly elevated pain intensity in the first 20% of the time to task failure and caused a significantly (P < 0.05) shorter time to task failure (448 ± 240 s) compared with the isotonic saline (605 ± 285 s) and control (514 ± 197 s) conditions.
",['18 participants completed a time to task failure at 20'],"['hypertonic saline combined with 10% MVT', 'maximal voluntary torque (MVT), a resting hypertonic saline intramuscular injection', 'isotonic saline, hypertonic saline or a control (no injection', 'exercise-induced pain (EIP', 'isotonic saline', 'hypertonic saline injection', 'hypertonic saline']","['quality of pain', 'knee extensors decreases single-limb isometric time to task failure', 'intensity of pain', 'elevated pain intensity', 'qualitative experience of pain', 'McGill Pain Questionnaire']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}]",,0.144328,"10% MVT with hypertonic saline significantly elevated pain intensity in the first 20% of the time to task failure and caused a significantly (P < 0.05) shorter time to task failure (448 ± 240 s) compared with the isotonic saline (605 ± 285 s) and control (514 ± 197 s) conditions.
","[{'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'Smith', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham, Kent, ME4 4AG, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Micklewright', 'Affiliation': 'School of Sport, Rehabilitation and Exercise Sciences, University of Essex, Wivenhoe Park, Colchester, UK.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Winter', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham, Kent, ME4 4AG, UK.'}, {'ForeName': 'Alexis R', 'Initials': 'AR', 'LastName': 'Mauger', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham, Kent, ME4 4AG, UK. lex.mauger@gmail.com.'}]",European journal of applied physiology,['10.1007/s00421-020-04425-2']
1465,32610370,Improving pulp revascularization outcomes with buccal fat autotransplantation.,"Several techniques have been introduced to improve the pulp revascularization outcomes. The use of the tissue graft can create more practical tissue regeneration, provide vascular supply, and enhance tissue healing. The aim of the present study was to investigate the histologic and molecular outcomes of pulp revascularization with buccal fat autotransplantation. Fifty-six open apex roots from four dogs aged 4-6 months were randomly allocated to five groups of endodontic regeneration models: Group 1 (negative control, n = 4); Group 2 (control and without intervention, n = 4); Group 3 (blood clot, n = 16); Group 4 (buccal fat autotransplantation, n = 16); and Group 5 (blood clot plus buccal fat autotransplantation, n = 16). After 3 months, the extracted dog teeth were analyzed by histological and immunohistochemical techniques. Furthermore, real-time quantitative polymerase chain reactions were implemented to assess the gene expression profiles of dentin sialophosphoprotein (DSPP), dentin matrix protein (DMP), collagen I (COL1), and alkaline phosphatase (ALP) on regenerated tissue in the root canals. There were no significant differences in the severity of inflammation and necrosis between intervention groups. Immunohistochemical analysis showed significant differences among the study groups in expression level of extracellular glycoproteins such as fibronectin, laminin, and tenascin C. Group 5 showed an increase in the expression of DMP1 and COL1 genes. The expression of DSPP gene increased significantly in Group 4. The expression of ALP gene increased significantly in Group 3. Using this procedure may open new fields of research for regenerative endodontic procedure in which tissue autotransplant, particularly adipose tissue, may improve the outcomes of pulp revascularization.",2020,"Immunohistochemical analysis showed significant differences among the study groups in expression level of extracellular glycoproteins such as fibronectin, laminin and tenascin C. Group 5 showed an increase in the expression of DMP1 and COL1 genes.",['Fifty six open apex roots from 4 dogs aged 4-6 months'],"['endodontic regeneration models', 'pulp revascularization with buccal fat autotransplantation', ' Group 2 (control and without intervention, n=4); Group 3 (blood clot, n=16); Group 4 (buccal fat autotransplantation, n=16); Group 5 (blood clot plus buccal fat autotransplantation', 'buccal fat autotransplantation']","['expression of DSPP gene', 'severity of inflammation and necrosis', 'expression of DMP1 and COL1 genes', 'expression of ALP gene', 'gene expression profiles of dentin sialophosphoprotein (DSPP), dentin matrix protein (DMP), collagen I (COL1) and alkaline phosphatase (ALP']","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0914005', 'cui_str': 'dentin sialophosphoprotein'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C1449575', 'cui_str': 'Microarray Analysis'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}]",,0.0184629,"Immunohistochemical analysis showed significant differences among the study groups in expression level of extracellular glycoproteins such as fibronectin, laminin and tenascin C. Group 5 showed an increase in the expression of DMP1 and COL1 genes.","[{'ForeName': 'Saber', 'Initials': 'S', 'LastName': 'Khazaei', 'Affiliation': 'Department of Endodontics and Dental Research Center, Dental Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Abbasali', 'Initials': 'A', 'LastName': 'Khademi', 'Affiliation': 'Department of Endodontics and Dental Research Center, Dental Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Torabinejad', 'Affiliation': 'School of Dentistry, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Nasr Esfahani', 'Affiliation': 'Department of Animal Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, ACECR, Isfahan, Iran.'}, {'ForeName': 'Mozafar', 'Initials': 'M', 'LastName': 'Khazaei', 'Affiliation': 'Fertility and Infertility Research Center, Health Technology Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Sayed Mohammad', 'Initials': 'SM', 'LastName': 'Razavi', 'Affiliation': 'Department of Oral and Maxillofacial Pathology and Dental Implant Research Center, Dental Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of tissue engineering and regenerative medicine,['10.1002/term.3094']
1466,32615145,Does connectedness to nature improve the eating behaviours of pre-schoolers? Emerging evidence from the Play&Grow randomised controlled trial in Hong Kong.,"BACKGROUND


Nature-based interventions, which focus on outdoor play, mental health, and self-directed autonomous play, are becoming popular in promoting well-being. The objective of this study was to test whether connecting to nature would contribute to better feeding and eating habits in families with pre-schoolers.
METHODS


241 families with children aged two to five were randomly assigned to the Intervention (IG) and Control Groups (CG). IG received 10 sessions of a family-based programme, which included a novel Connectedness to Nature (CN) element. CG received only the government's health recommendations. The effectiveness of the intervention's primary outcomes (CN, eating/feeding behaviours) was analysed by a repeated measures structural equation model with intervention status as a causal predictor.
RESULTS


204 families (IG, n = 120; CG, n = 84) completed the measurements before and after the trial. The intervention had a medium effect on caregivers' CN (f 2  = 0.16, (95%CI = 0.06, 0.30)) and a large effect on children's CN (f 2  = 0.58, (95%CI = 0.36, 0.89)). In the IG, children's CN strongly predicted caregivers' feeding style (β = 0.48 (p < .01, 95%CI = 0.14, 0.83)) and moderately, children's eating behaviours (β = 0.21 (p = .16, 95%CI = -0.09, 0.52)). This produced a positive trend for greater vegetable consumption in the IG compared to the CG (β = 0.20 (95%CI = 0.01, 0.39) vs. β = -0.05, (95%CI = -0.18, 0.08)). Interestingly, the path values in the CG significantly reflected the traditional pattern, (e.g., parental feeding style strongly influenced children's eating behaviour (β = 0.33, p = .001, 95%CI = 0.13, 0.54).
CONCLUSIONS


The Play&Grow intervention positively increased caregivers' and children's CN. It also improved eating behaviors in children independent of their caregivers' feeding style. This may indicate a higher degree of autonomy in children's eating behaviour if they are exposed to nature. Further research should test the CN component in promotion of healthy eating in pre-schoolers.",2020,"The intervention had a medium effect on caregivers' CN (f 2  = 0.16, (95%CI = 0.06, 0.30)) and a large effect on children's CN (f 2  = 0.58, (95%CI = 0.36, 0.89)).","['241 families with children aged two to five', '204 families (IG n\u202f=\u202f120, CG n\u202f=\u202f84']","['Intervention (IG) and Control Groups (CG', 'Play&Grow intervention']","[""children's eating behaviours"", 'vegetable consumption', 'feeding and eating habits', ""caregivers' feeding style"", ""caregivers' and children's CN"", ""children's eating behaviour"", 'eating behaviors']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0349590', 'cui_str': 'Nature'}]",241.0,0.128134,"The intervention had a medium effect on caregivers' CN (f 2  = 0.16, (95%CI = 0.06, 0.30)) and a large effect on children's CN (f 2  = 0.58, (95%CI = 0.36, 0.89)).","[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Sobko', 'Affiliation': 'School of Biological Sciences, Faculty of Science, The University of Hong Kong, Hong Kong. Electronic address: tsobko@hku.hk.'}, {'ForeName': 'Gavin T L', 'Initials': 'GTL', 'LastName': 'Brown', 'Affiliation': 'Quantitative Data Analysis and Research Unit, Faculty of Education & Social Work, The University of Auckland, New Zealand.'}, {'ForeName': 'Will H G', 'Initials': 'WHG', 'LastName': 'Cheng', 'Affiliation': 'School of Biological Sciences, Faculty of Science, The University of Hong Kong, Hong Kong.'}]",Appetite,['10.1016/j.appet.2020.104781']
1467,32616433,Comparative Cost-effectiveness of Aflibercept and Ramucirumab in Combination with Irinotecan and Fluorouracil-based Therapy for the Second-line Treatment of Metastatic Colorectal Cancer in Japan.,"PURPOSE


The addition of aflibercept (AFL) or ramucirumab (RAM) to folinic acid, fluorouracil, and irinotecan (FOLFIRI) prolongs overall survival and progression-free survival compared with FOLFIRI alone in patients with metastatic colorectal cancer (mCRC) as second-line therapy. Although these combination regimens are recommended among the standard therapies, significant additional cost is a concern. The comparative cost-effectiveness of AFL and RAM was examined from the perspective of the Japanese health care payer.
METHODS


A partitioned survival analysis was constructed. The data sources were the VELOUR (Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen) and RAISE (Ramucirumab Versus Placebo in Combination With Second-Line FOLFIRI in Patients With Metastatic Colorectal Carcinoma That Progressed During or After First-Line Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine) trials, which compared FOLFIRI alone with AFL or RAM in second-line treatment for mCRC. The cost and effectiveness of the combination of AFL or RAM with FOLFIRI were compared with those of FOLFIRI alone and examined between both agents in a 10-year time horizon. The health outcomes were life-years (LYs) and quality-adjusted life-years (QALYs). The costs were 2019 revisions to the drug prices and medical fees. The robustness of the model was verified by 1-way sensitivity analyses and a probability sensitivity analysis. A 2% annual discount was applied to the expenses and QALYs. A willingness-to-pay threshold of ¥7.5 million was used.
FINDINGS


Compared with FOLFIRI alone, combination AFL or RAM with FOLFIRI had incremental effects of 0.173 QALYs (0.253 LYs) and 0.137 QALYs (0.197 LYs), incremental costs of ¥3,423,481 (US $31,010) and ¥5,766,106 (US $52,229), and incremental cost-effectiveness ratios of ¥19, 836, 504 (US $179,678) and ¥41, 947, 989 (US $379,964) per QALY, respectively. Results of 1-way sensitivity analyses and probability sensitivity analysis all exceeded a willingness-to-pay threshold of ¥7.5 million. In the comparison of the 2 agents, AFL was a dominant over RAM.
IMPLICATIONS


Adding AFL or RAM to FOLFIRI in the second line of mCRC treatment was not cost-effective in the Japanese health care system. On the basis of the results of this study, in the treatment of mCRC, it will be necessary to adjust the prices of AFL and RAM with the improvement of clinical parameters, such as survival time and adverse events. Of the 2 agents, AFL was more cost-effective than RAM.",2020,"Compared with FOLFIRI alone, combination AFL or RAM with FOLFIRI had incremental effects of 0.173 QALYs (0.253 LYs) and 0.137 QALYs (0.197 LYs), incremental costs of ¥3,423,481 (US $31,010) and ¥5,766,106 (US $52,229), and incremental cost-effectiveness ratios of ¥19, 836, 504 (US $179,678) and ¥41, 947, 989 (US $379,964) per QALY, respectively.","['Patients', 'Patients With Metastatic Colorectal Cancer', 'Metastatic Colorectal Cancer in Japan', 'With Metastatic Colorectal Carcinoma', 'patients with metastatic colorectal cancer (mCRC']","['Irinotecan and Fluorouracil-based Therapy', 'FOLFIRI alone with AFL or RAM', 'VELOUR (Aflibercept Versus Placebo', 'AFL', 'Aflibercept and Ramucirumab', 'AFL and RAM', 'FOLFIRI alone', 'Irinotecan and 5-FU', 'aflibercept (AFL) or ramucirumab (RAM) to folinic acid, fluorouracil, and irinotecan (FOLFIRI', 'Oxaliplatin Based Regimen) and RAISE (Ramucirumab Versus Placebo', 'Bevacizumab, Oxaliplatin, and a Fluoropyrimidine']","['life-years (LYs) and quality-adjusted life-years (QALYs', 'survival time and adverse events', 'incremental cost-effectiveness ratios', 'cost and effectiveness', 'overall survival and progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0078152', 'cui_str': 'velour'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0161037,"Compared with FOLFIRI alone, combination AFL or RAM with FOLFIRI had incremental effects of 0.173 QALYs (0.253 LYs) and 0.137 QALYs (0.197 LYs), incremental costs of ¥3,423,481 (US $31,010) and ¥5,766,106 (US $52,229), and incremental cost-effectiveness ratios of ¥19, 836, 504 (US $179,678) and ¥41, 947, 989 (US $379,964) per QALY, respectively.","[{'ForeName': 'Munenobu', 'Initials': 'M', 'LastName': 'Kashiwa', 'Affiliation': 'Division of Pharmacy, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan; Department of Pharmacy, First Towakai Hospital, Takatsuki, Japan. Electronic address: munenobuk@stu.kanazawa-u.ac.jp.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Matsushita', 'Affiliation': 'Division of Pharmaceutical Sciences, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.05.013']
1468,32618692,Prospective Randomized Controlled Trial of Video- Versus Recall-Assisted Reflection in Simulation-Based Teaching on Acquisition and Retention of Airway Skills Among Trainees Intubating Critically Ill Patients.,"OBJECTIVES


Conventionally, simulation-based teaching involves reflection on recalled events (recall-assisted reflection). Instead of recall, video-assisted reflection may reduce recall bias and improve skills retention by contributing to visual memory. Here, we test the hypothesis that when compared with recall, video-assisted reflection results in higher acquisition and retention of skills involved in airway management among junior critical care doctors.
DESIGN


Randomized control trial. Participants were randomized 1:1 to video-assisted reflection or recall-assisted reflection group.
SETTING


University-affiliated tertiary care center.
SUBJECTS


Junior critical care doctors.
INTERVENTION


Video-assisted reflection.
MEASUREMENTS AND MAIN RESULTS


All participants underwent simulation-based teaching of technical and nontechnical airway skills involved in managing a critically ill patient. These skills were assessed before, post-workshop, and in the following fourth week, by two independent blinded assessors using a validated scoring tool. Quality of debrief was assessed using a validated questionnaire. Repeated-measures analysis of variance was used to assess time and group interaction. Forty doctors were randomized. At baseline, the groups had similar airway experience (p = 0.34) and skill scores (p = 0.97). There was a significant interaction between study groups and changes over time for total skill scores (F[2, 37] = 4.06; p = 0.02). Although both the study groups had similar and significant improvement in total skills scores at the postworkshop assessment, the decline in total skills scores at delayed assessment (F[1, 38] = 5.64; p = 0.02) was significantly more in the recall-assisted reflection group when compared with the video-assisted reflection group. This resulted in lower mean skill scores in the recall-assisted reflection group when compared with the video-assisted reflection group in the delayed assessment (89.45 [19.32] vs 110.10 [19.54]; p < 0.01). Better retention was predominantly in the nontechnical skills. The perceived quality of debrief was similar between the two groups.
CONCLUSION


When compared with recall, video-assisted reflection resulted in similar improvement in airway skills, but better retention over time.",2020,This resulted in lower mean skill scores in the recall-assisted reflection group when compared with the video-assisted reflection group in the delayed assessment (89.45 [19.32] vs 110.10 [19.54]; p < 0.01).,"['junior critical care doctors', 'Intubating Critically Ill Patients', 'Junior critical care doctors', 'Forty doctors', 'University-affiliated tertiary care center', 'Trainees']","['video-assisted reflection or recall-assisted reflection group', 'Video', 'Video-assisted reflection']","['total skills scores', 'quality of debrief', 'airway skills', 'mean skill scores', 'Skills', 'recall bias and improve skills retention', 'total skill scores', 'Acquisition and Retention of Airway', 'similar airway experience', 'skill scores', 'Quality of debrief']","[{'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",40.0,0.212539,This resulted in lower mean skill scores in the recall-assisted reflection group when compared with the video-assisted reflection group in the delayed assessment (89.45 [19.32] vs 110.10 [19.54]; p < 0.01).,"[{'ForeName': 'Shivesh', 'Initials': 'S', 'LastName': 'Prakash', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Laver', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Giresh', 'Initials': 'G', 'LastName': 'Chandran', 'Affiliation': 'Department of Anaesthesia, Flinders Medical Centre, Bedford Park, SA, Australia.'}, {'ForeName': 'Lachlan', 'Initials': 'L', 'LastName': 'Kerr', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Lambert', 'Initials': 'L', 'LastName': 'Schuwirth', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bersten', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}]",Critical care medicine,['10.1097/CCM.0000000000004448']
1469,32619458,"Acute psychological stress, autonomic function, and arterial stiffness among women.","This study aimed to investigate the effect of acute psychological stress on autonomic function and arterial stiffness, and to test a mediating role of changes in autonomic function between acute stress and arterial stiffness. Eighty-five healthy female adults were randomized into either an experimental or control group. The Trier Social Stress Test (TSST) was used to induce acute psychological stress. Autonomic function (measured by pre-ejection period [PEP] from cardiac impedance and high frequency [HF] of heart rate variability [HRV]) and arterial stiffness (measured by carotid and femoral pulse wave velocity [cfPWV] and augmentation index [AIx]) were assessed before and after the TSST. The mean age of the participants was 28.78 (±9.84) years old. Experimental group participants had a significant increase in cfPWV (p = .025) and AIx (p = .017) following the stressor, compared with those in the control group, after controlling for age, body mass index, and systolic blood pressure. However, no significant group differences were observed in changes in PEP (p = .181) and HF (p = .058). Changes in PEP and HF were neither associated with changes in cfPWV (p = .975 and p = .654, respectively), nor in AIx (p = .376 and p = .323, respectively). The results suggest that even a brief period of mild to moderate stress, which does not cause sustainable changes in autonomic function, may still exert significant adverse effects on arterial stiffness. The changes in arterial stiffness were not related to changes in autonomic function. Future experimental studies with several measurement points are recommended to identify distinct effects of stress on autonomic function and arterial stiffness.",2020,"Experimental group participants had a significant increase in cfPWV (p = .025) and AIx (p = .017) following the stressor, compared with those in the control group, after controlling for age, body mass index, and systolic blood pressure.","['The mean age of the participants was 28.78 (±9.84) years old', 'Eighty-five healthy female adults', 'women']",['Trier Social Stress Test (TSST'],"['heart rate variability [HRV]) and arterial stiffness (measured by carotid and femoral pulse wave velocity [cfPWV] and augmentation index [AIx', 'cfPWV', 'Autonomic function', 'Acute psychological stress, autonomic function, and arterial stiffness', 'arterial stiffness', 'autonomic function and arterial stiffness', 'systolic blood pressure', 'autonomic function', 'changes in PEP']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0686752', 'cui_str': 'Well female adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0999177', 'cui_str': 'Aix'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}]",85.0,0.0168326,"Experimental group participants had a significant increase in cfPWV (p = .025) and AIx (p = .017) following the stressor, compared with those in the control group, after controlling for age, body mass index, and systolic blood pressure.","[{'ForeName': 'Jeongok G', 'Initials': 'JG', 'LastName': 'Logan', 'Affiliation': 'University of Virginia, School of Nursing, McLeod Hall 4011, 225 Jeanette Lancaster Way, Charlottesville, VA 22903, United States. Electronic address: jl3zj@virginia.edu.'}, {'ForeName': 'Bethany A', 'Initials': 'BA', 'LastName': 'Teachman', 'Affiliation': 'University of Virginia, Department of Psychology, 207 Gilmer Hall, Charlottesville, VA 22903, United States. Electronic address: bat5x@virginia.edu.'}, {'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'University of Virginia, School of Nursing, McLeod Hall 4034, 225 Jeanette Lancaster Way, Charlottesville, VA 22903, United States. Electronic address: xl5tb@virginia.edu.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Farber', 'Affiliation': 'University of Virginia, Public Health Sciences, OMS 3817B, Charlottesville, VA 22908, United States. Electronic address: crf2s@virginia.edu.'}, {'ForeName': 'Zhenqi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'University of Virginia, School of Medicine, Suite 2100, 450 Ray C. Hunt Drive, Charlottesville, VA 22903, United States. Electronic address: zl3e@virginia.edu.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Annex', 'Affiliation': 'Augusta University, Medical College of Georgia, 1120 15th St. Augusta, GA 30912, United States. Electronic address: bannex@augusta.edu.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.06.015']
1470,32619524,Design of a randomized placebo controlled trial of high dose intravenous thiamine for the prevention of delirium in allogeneic hematopoietic stem cell transplantation.,"BACKGROUND


Delirium is a highly prevalent and preventable neuropsychiatric condition with major health consequences. Thiamine deficiency is a well-established cause of delirium in those with chronic, severe alcoholism, but there remains an underappreciation of its significance in non-alcoholic populations, including patients with cancer. Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
OBJECTIVES


The primary objective of this clinical trial is to determine if high dose IV thiamine can prevent delirium in patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer. Secondary objectives are to determine if thiamine status is predictive of delirium onset and if high dose IV thiamine can attenuate the deleterious impact of delirium on health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes.
METHODS


In this phase II study, we are recruiting 60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose IV thiamine (n = 30) versus placebo (n = 30), and systematically evaluating all participants for delirium and related comorbidities. We use the Delirium Rating Scale to measure the severity and duration of delirium during hospitalization for HSCT. We obtain thiamine levels weekly during the transplantation hospitalization. We assess HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function prior to and at one, three, and six months after transplantation.",2020,"Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
","['60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose', 'patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer', 'Allogeneic Hematopoietic Stem Cell Transplantation', 'patients with cancer']","['Placebo', 'Thiamine', 'thiamine', 'intravenous (IV) thiamine', 'IV thiamine', 'placebo']","['HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function', 'Delirium Rating Scale', 'health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.367689,"Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population.
","[{'ForeName': 'Zev M', 'Initials': 'ZM', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: zev_nakamura@med.unc.edu.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Rosenstein', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Quillen', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Chien', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Wood', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Shea', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Eliza M', 'Initials': 'EM', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106076']
1471,32619525,Modulation of startle and heart rate responses by fear of physical activity in patients with heart failure and in healthy adults.,"Fear of physical activity (FoPA) has been suggested as a barrier to physical activity in patients with heart failure and might be associated with low adherence to exercise regimen despite medical guideline recommendations. The present study examined physiological indicators of FoPA by assessing startle modulation (via EMG at the orbicularis oculi muscle) and heart rate responses (derived from ECG) after affective priming with lexical stimuli of positive, neutral, and negative valence, as well as words related to physical activity as potentially phobic cues. After screening for FoPA in patients with heart failure and healthy adults, twenty participants each were assigned to one of three subsamples: a healthy control group and two cardiac patient groups scoring either low or high on FoPA. The high-FoPA group showed startle potentiation and more pronounced heart rate acceleration (than did controls) in the phobic prime condition, indicating defensive response mobilization. Among the patients, higher FoPA accounted for 30% of the startle potentiation by phobic priming, whereas general anxiety, depression, and disease severity were no significant predictors of startle modulation. These findings suggest that FoPA in patients with heart failure is associated with defensive responses on a physiological level that might be indicative of avoidance behavior, thereby contributing to low adherence to exercise regimen. Thus, FoPA presents a significant target for psychological interventions to foster physical activity in cardiac patients.",2020,"Differences in FoPA accounted for 30% of the startle potentiation by phobic priming, whereas general anxiety, depression, and disease severity were no significant predictors in patients with heart failure.","['patients with heart failure', 'patients with heart failure and associated with lower physical activity despite medical exercise prescriptions', 'patients with heart failure and healthy adults, twenty participants each', 'Patients with Heart Failure and in Healthy Adults']","['Fear of physical activity (FoPA', 'FoPA', 'healthy control group and two cardiac patient groups scoring either low or high on FoPA']","['startle potentiation and heart rate acceleration (i.e., mobilization of defensive behavior', 'general anxiety, depression, and disease severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0588464', 'cui_str': 'Exercise on prescription'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0086188', 'cui_str': 'Drug Potentiation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",20.0,0.0134447,"Differences in FoPA accounted for 30% of the startle potentiation by phobic priming, whereas general anxiety, depression, and disease severity were no significant predictors in patients with heart failure.","[{'ForeName': 'Jeremia Mark', 'Initials': 'JM', 'LastName': 'Hoffmann', 'Affiliation': 'Division of Health Psychology, Department of Nursing Science, Trier University, Universitätsring 15, D-54286 Trier, Germany.'}, {'ForeName': 'Johannes B', 'Initials': 'JB', 'LastName': 'Finke', 'Affiliation': 'Department of Clinical Psychology, University of Siegen, Adolf-Reichwein-Straße 2a, D-57076 Siegen, Germany; Institute of Psychobiology, Department of Clinical Psychophysiology, Trier University, Johanniterufer 15, D-54290 Trier, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Schächinger', 'Affiliation': 'Institute of Psychobiology, Department of Clinical Psychophysiology, Trier University, Johanniterufer 15, D-54290 Trier, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schulz', 'Affiliation': 'Institute for Health and Behaviour, Department of Behavioural and Cognitive Sciences, University of Luxembourg, 11, Porte des Sciences, L-4366 Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Vögele', 'Affiliation': 'Institute for Health and Behaviour, Department of Behavioural and Cognitive Sciences, University of Luxembourg, 11, Porte des Sciences, L-4366 Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Spaderna', 'Affiliation': 'Division of Health Psychology, Department of Nursing Science, Trier University, Universitätsring 15, D-54286 Trier, Germany. Electronic address: spaderna@uni-trier.de.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113044']
1472,32621905,The ENGAGE-2 study: Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes in a randomized controlled trial (Phase 2).,"Despite evidence for effective integrated behavior therapy for treating comorbid obesity and depression, treatment response is highly variable and the underlying neurobiological mechanisms remain unknown. This hampers efforts to identify mechanistic targets in order to optimize treatment precision and potency. Funded within the NIH Science of Behavior Change (SOBC) Research Network, the 2-phased ENGAGE research project applies an experimental precision medicine approach to address this gap. The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy. This therapy combines a video-based behavioral weight loss program and problem-solving therapy for depression, with as-needed intensification of antidepressant medications, and its clinical effectiveness was demonstrated within a parent randomized clinical trial. Here, we describe the ENGAGE Phase 2 (ENGAGE-2) study protocol which builds on Phase 1 in 2 ways: (1) pilot testing of an motivational interviewing-enhanced, integrated behavior therapy in an independent, primarily minority patient sample, and (2) evaluation of a priori defined neural targets, specifically the negative affect (threat and sadness) circuits which demonstrated engagement and malleability in Phase 1, as mediators of therapeutic outcomes. Additionally, the Phase 2 study includes a conceptual and methodological extension to explore the role of microbiome-gut-brain and systemic immunological pathways in integrated behavioral treatment of obesity and depression. This protocol paper documents the conceptualization, design and the transdisciplinary methodologies in ENGAGE-2, which can inform future clinical and translational research in experimental precision medicine for behavior change and chronic disease management. Trial registration: ClinicalTrials.gov #NCT 03,841,682.",2020,"The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy.",[],"['motivational interviewing-enhanced, integrated behavior therapy', 'video-based behavioral weight loss program and problem-solving therapy']",[],[],"[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}]",[],,0.0347898,"The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy.","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Olusola A', 'Initials': 'OA', 'LastName': 'Ajilore', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL 60612, United States.'}, {'ForeName': 'Corina R', 'Initials': 'CR', 'LastName': 'Ronneberg', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA 98104, United States.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Lavori', 'Affiliation': 'Department of Biomedical Data Science, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States; MIRECC VISN21, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wielgosz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Wittels', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Amruta', 'Initials': 'A', 'LastName': 'Barve', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Aashutos S', 'Initials': 'AS', 'LastName': 'Patel', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Tessa L', 'Initials': 'TL', 'LastName': 'Eckley', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Stetz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Ben S', 'Initials': 'BS', 'LastName': 'Gerber', 'Affiliation': 'Division of Academic Internal Medicine and Geriatrics, College of Medicine, University of Illinois at Chicago, Chicago, IL 60612, United States.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': 'Departments of Biobehavioral Health and Medicine, Pennsylvania State University, University Park, PA 16802, United States.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Simmons', 'Affiliation': 'National Institute of Mental Health (NIMH), National Institutes of Health, Bethesda, MD 20892, United States.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA 94304, United States; Department of Medicine, Stanford University, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States; MIRECC VISN21, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States; Department of Medicine, University of Illinois at Chicago, Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106072']
1473,32621918,Dexmedetomidine pretreatment attenuates myocardial ischemia reperfusion induced acute kidney injury and endoplasmic reticulum stress in human and rat.,"BACKGROUND


Patients undergoing cardiopulmonary bypass (CPB) often develop acute kidney injury (AKI) caused by myocardial ischemia reperfusion (MI/R), and this renal injury can be resolved notably by dexmedetomidine. Endoplasmic reticulum (ER) stress was reported to get involved in organ injury including AKI.
OBJECTIVES


The current study aimed to address the correlation between MI/R induced AKI with ER stress and to assess the effects of dexmedetomidine pretreatment on AKI protection.
METHOD


Patients selected for heart valve replacement surgery were randomly assigned to NS group (pre-anesthesia with 0.9% NaCl) and DEX group (pre-anesthesia with dexmedetomidine). Rat MI/R model was induced by occluding coronary artery for 30 min followed by 48-hour reperfusion. Rats were randomized into Sham (0.9% NaCl), I/R (MI/R + 0.9% NaCl) and I/R + DEX (MI/R + dexmedetomidine). Organ function and ER stress condition were evaluated by blood chemistry, pathology, and molecular test.
RESULTS


Clinical data indicated dexmedetomidine pretreatment attenuated AKI and oxidative stress as well as postischemic myocardial injury in patients. Accordingly animal results suggested dexmedetomidine reduced cellular injury and improved postischemic myocardial and renal function. Dexmedetomidine also reduced myocardial and renal cells apoptosis and down-regulated ER stress.
CONCLUSIONS


These results suggested that dexmedetomidine pretreatment attenuates MI/R injury-induced AKI by relieving the ER stress.",2020,"Dexmedetomidine also reduced myocardial and renal cells apoptosis and down-regulated ER stress.
","['Patients undergoing', 'Patients selected for heart valve replacement surgery', 'human and rat']","['cardiopulmonary bypass (CPB', 'NS group (pre-anesthesia with 0.9% NaCl) and DEX group (pre-anesthesia with dexmedetomidine', 'Dexmedetomidine', '\u202fDEX (MI/R\u202f+\u202fdexmedetomidine', 'dexmedetomidine']","['MI/R injury-induced AKI', 'Endoplasmic reticulum (ER) stress', 'AKI and oxidative stress', 'myocardial and renal cells apoptosis and down-regulated ER stress', 'cellular injury and improved postischemic myocardial and renal function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0190173', 'cui_str': 'Heart valve replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0014239', 'cui_str': 'Endoplasmic reticulum'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C3178870', 'cui_str': 'Stress, Endoplasmic Reticulum'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",,0.0396497,"Dexmedetomidine also reduced myocardial and renal cells apoptosis and down-regulated ER stress.
","[{'ForeName': 'Chaoliang', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China. Electronic address: chaolt@ustc.edu.cn.'}, {'ForeName': 'Yida', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan 430060, Hubei, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesia, Critical Care & Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02144, USA.'}, {'ForeName': 'Jiazhen', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Emergency, Huashan Hospital North, Fudan University, Shanghai, 201907, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan 430060, Hubei, China.'}, {'ForeName': 'Jiawu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China.'}, {'ForeName': 'Qingtian', 'Initials': 'Q', 'LastName': 'Geng', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China.'}, {'ForeName': 'Xinghan', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Department of Clinical Laboratory, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230000, Anhui, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Chai', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China. Electronic address: xiaoqingchai@163.com.'}]",Life sciences,['10.1016/j.lfs.2020.118004']
1474,32622585,"Corrigendum to ""A controlled clinical crossover trial of exercise training to improve cognition and neural communication in pediatric brain tumor survivors"" [Clin. Neurophysiol. 131 (2020) 1533-1547].",,2020,,"['pediatric brain tumor survivors"" [Clin', '131']",['exercise training'],['cognition and neural communication'],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0006118', 'cui_str': 'Neoplasm of brain'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",,0.0160611,,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cox', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada; Department of Psychology, University of Toronto, 100 St. George Street, Toronto, ON M5S 3G3, Canada. Electronic address: elizabeth.cox@sickkids.ca.'}, {'ForeName': 'Sonya', 'Initials': 'S', 'LastName': 'Bells', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: sonya.bells@sickkids.ca.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Timmons', 'Affiliation': 'Department of Pediatrics, McMaster University, 1200 Main Street W., Hamilton, ON L8N 3Z5, Canada. Electronic address: timmonbw@mcmaster.ca.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Laughlin', 'Affiliation': 'Diagnostic Imaging, SickKids, 555 University Avenue, Toronto, ON M5G 1X8, Canada. Electronic address: suzanne.laughlin@sickkids.ca.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bouffet', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: eric.bouffet@sickkids.ca.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'de Medeiros', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: cynthia.demedeiros@sickkids.ca.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Beera', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: kirangbeera@gmail.com.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Harasym', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada. Electronic address: arasyd@mcmaster.ca.'}, {'ForeName': 'Donald J', 'Initials': 'DJ', 'LastName': 'Mabbott', 'Affiliation': 'Neurosciences & Mental Health, SickKids, 686 Bay Street, Toronto, ON M5G 0A4, Canada; Department of Psychology, University of Toronto, 100 St. George Street, Toronto, ON M5S 3G3, Canada. Electronic address: donald.mabbott@sickkids.ca.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.06.002']
1475,32623140,Emotion self-regulation training in major depressive disorder using simultaneous real-time fMRI and EEG neurofeedback.,"Simultaneous real-time fMRI and EEG neurofeedback (rtfMRI-EEG-nf) is an emerging neuromodulation approach, that enables simultaneous volitional regulation of both hemodynamic (BOLD fMRI) and electrophysiological (EEG) brain activities. Here we report the first application of rtfMRI-EEG-nf for emotion self-regulation training in patients with major depressive disorder (MDD). In this proof-of-concept study, MDD patients in the experimental group (n = 16) used rtfMRI-EEG-nf during a happy emotion induction task to simultaneously upregulate two fMRI and two EEG activity measures relevant to MDD. The target measures included BOLD activities of the left amygdala (LA) and left rostral anterior cingulate cortex (rACC), and frontal EEG asymmetries in the alpha band (FAA, [7.5-12.5] Hz) and high-beta band (FBA, [21-30] Hz). MDD patients in the control group (n = 8) were provided with sham feedback signals. An advanced procedure for improved real-time EEG-fMRI artifact correction was implemented. The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC. Average individual FAA changes during the rtfMRI-EEG-nf task positively correlated with depression and anhedonia severities, and negatively correlated with after-vs-before changes in depressed mood ratings. Temporal correlations between the FAA and FBA time courses and the LA BOLD activity were significantly enhanced during the rtfMRI-EEG-nf task. The experimental group participants reported significant mood improvements after the training. Our results suggest that the rtfMRI-EEG-nf may have potential for treatment of MDD.",2020,"The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC.",['patients with major depressive disorder (MDD'],"['Emotion self-regulation training', 'rtfMRI-EEG-nf for emotion self-regulation training']","['BOLD activities of the left amygdala (LA) and left rostral anterior cingulate cortex (rACC), and frontal EEG asymmetries in the alpha band (FAA, [7.5-12.5] Hz) and high-beta band (FBA, [21-30] Hz', 'Average individual FAA changes', 'depression and anhedonia severities', 'LA BOLD activity', 'fMRI connectivity', 'LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0060441', 'cui_str': 'flavone acetic acid'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",,0.014664,"The experimental group participants demonstrated significant upregulation of the LA BOLD activity, FAA, and FBA during the rtfMRI-EEG-nf task, as well as significant enhancement in fMRI connectivity between the LA and left rACC.","[{'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Zotev', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA. Electronic address: vzotev@laureateinstitute.org.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Mayeli', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA; Electrical and Computer Engineering, University of Oklahoma, Tulsa, OK, USA.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Misaki', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Bodurka', 'Affiliation': 'Laureate Institute for Brain Research, Tulsa, OK, USA; Stephenson School of Biomedical Engineering, University of Oklahoma, Norman, OK, USA. Electronic address: jbodurka@laureateinstitute.org.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102331']
1476,32623370,"Drainage, irrigation and fibrinolytic therapy (DRIFT) for posthaemorrhagic ventricular dilatation: 10-year follow-up of a randomised controlled trial.","BACKGROUND


Progressive ventricular dilatation after intraventricular haemorrhage (IVH) in preterm infants has a very high risk of severe disability and death. Drainage, irrigation and fibrinolytic therapy (DRIFT), in a randomised controlled trial (RCT), reduced severe cognitive impairment at 2 years.
OBJECTIVE


To assess if the cognitive advantage of DRIFT seen at 2 years persisted until school age.
PARTICIPANTS


The RCT conducted in four centres recruited 77 preterm infants with IVH and progressive ventricular enlargement over specified measurements. Follow-up was at 10 years of age.
INTERVENTION


Intraventricular injection of a fibrinolytic followed by continuous lavage, until the drainage was clear, and standard care consisting of control of expansion by lumbar punctures and if expansion persisted via a ventricular access device.
PRIMARY OUTCOME


Cognitive quotient (CQ), derived from the British Ability Scales and Bayley III Scales, and survival without severe cognitive disability.
RESULTS


Of the 77 children randomised, 12 died, 2 could not be traced, 10 did not respond and 1 declined at 10-year follow-up. 28 in the DRIFT group and 24 in the standard treatment group were assessed by examiners blinded to the intervention. The mean CQ score was 69.3 (SD=30.1) in the DRIFT group and 53.7 (SD=35.7) in the standard treatment group (unadjusted p=0.1; adjusted p=0.01, after adjustment for the prespecified variables sex, birth weight and IVH grade). Survival without severe cognitive disability was 66% in the DRIFT group and 35% in the standard treatment group (unadjusted p=0.019; adjusted p=0.003).
CONCLUSION


DRIFT is the first intervention for posthaemorrhagic ventricular dilatation to objectively demonstrate sustained cognitive improvement.
TRIAL REGISTRATION NUMBER


ISRCTN80286058.",2020,"Survival without severe cognitive disability was 66% in the DRIFT group and 35% in the standard treatment group (unadjusted p=0.019; adjusted p=0.003).
","['77 children randomised, 12 died, 2 could not be traced, 10 did not respond and 1 declined at 10-year follow-up', 'posthaemorrhagic ventricular dilatation', 'preterm infants', '77 preterm infants with IVH and progressive ventricular enlargement over specified measurements']","['Drainage, irrigation and fibrinolytic therapy (DRIFT', 'fibrinolytic followed by continuous lavage, until the drainage was clear, and standard care consisting of control of expansion by lumbar punctures and if expansion persisted via a ventricular access device']","['mean CQ score', 'severe cognitive impairment', 'Survival without severe cognitive disability', 'Cognitive quotient (CQ), derived from the British Ability Scales and Bayley III Scales, and survival without severe cognitive disability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4552505', 'cui_str': 'PHVD'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C2675972', 'cui_str': 'Ventricular enlargement'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037943', 'cui_str': 'Lumbar puncture'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3554639', 'cui_str': 'Severe cognitive impairment'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451042', 'cui_str': 'British ability scales'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",77.0,0.16837,"Survival without severe cognitive disability was 66% in the DRIFT group and 35% in the standard treatment group (unadjusted p=0.019; adjusted p=0.003).
","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Luyt', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK karen.luyt@bristol.ac.uk.'}, {'ForeName': 'Sally L', 'Initials': 'SL', 'LastName': 'Jary', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Lea', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Odd', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Helen E', 'Initials': 'HE', 'LastName': 'Miller', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grazyna', 'Initials': 'G', 'LastName': 'Kmita', 'Affiliation': 'Faculty of Psychology, University of Warsaw, Warszawa, Poland.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Ophthalmology, Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Blair', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Morgan', 'Affiliation': ""Child Psychology, Community Children's Health Partnership, Bristol, UK.""}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Smith-Collins', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Walker-Cox', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Aquilina', 'Affiliation': 'Department of Neurosurgery, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Pople', 'Affiliation': 'Paediatric Neurosurgery, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Whitelaw', 'Affiliation': 'Neonatal Neurology, Bristol Medical School, Faculty of Health Sciences, University of Bristol, Bristol, UK.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2019-318231']
1477,32623425,Work-focused therapy for common mental disorders: A naturalistic study comparing an intervention group with a waitlist control group.,"BACKGROUND


Common mental disorders (CMD) are leading causes of sickness absence. Treatments for CMD that both reduce symptoms and support work participation urgently need to be developed.
OBJECTIVE


Determine the potential effects of work-focused therapy combining work interventions with either meta cognitive therapy or cognitive behavioural therapy (W-MCT/CBT) for patients with CMD on sick leave.
METHODS


Naturalistic study with a quasi-experimental approach. Pre- and post-scores (return to work, symptoms, return-to-work self-efficacy, clinical recovery from depression and anxiety) were compared between the intervention group (n = 87) who received immediate treatment over an average of 10.40 sessions (SD = 3.09) and the non-randomized waitlist control group (n = 95) that had waited an average of 11.18 weeks (SD = 2.29).
RESULTS


Significantly more patients returned fully to work in the intervention group (41.4%) than the control group (26.3%). Effect sizes for self-efficacy scores, depression and anxiety were large in the intervention group (d = 1.28, 1.01, 1.58), and significantly lower in the control group (d = 0.60, 0.14, 0.45). Significantly more patients in the treatment group than control group recovered from depression (54.1% vs. 12.8%) and anxiety (50.0% vs.10.6%).
CONCLUSIONS


W-MCT/CBT may be an effective intervention for patients on sick leave due to CMD.",2020,Significantly more patients returned fully to work in the intervention group (41.4%) than the control group (26.3%).,"['patients with CMD on sick leave', 'Naturalistic study with a quasi-experimental approach', 'common mental disorders']","['meta cognitive therapy or cognitive behavioural therapy (W-MCT/CBT', 'W-MCT/CBT']","['anxiety', 'depression', 'self-efficacy scores, depression and anxiety', 'Pre- and post-scores (return to work, symptoms, return-to-work self-efficacy, clinical recovery from depression and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.0689232,Significantly more patients returned fully to work in the intervention group (41.4%) than the control group (26.3%).,"[{'ForeName': 'Ragne G H', 'Initials': 'RGH', 'LastName': 'Gjengedal', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Silje E', 'Initials': 'SE', 'LastName': 'Reme', 'Affiliation': 'University of Oslo, Oslo, Norway.'}, {'ForeName': 'Kåre', 'Initials': 'K', 'LastName': 'Osnes', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Lagerfeld', 'Affiliation': 'Instituut Gak, Hilversum, The Netherlands.'}, {'ForeName': 'Roland W B', 'Initials': 'RWB', 'LastName': 'Blonk', 'Affiliation': 'Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Sandin', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Torkil', 'Initials': 'T', 'LastName': 'Berge', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Odin', 'Initials': 'O', 'LastName': 'Hjemdal', 'Affiliation': 'Diakonhjemmet Hospital, Oslo, Norway.'}]","Work (Reading, Mass.)",['10.3233/WOR-203208']
1478,32657437,Niacinamide mitigates SASP-related inflammation induced by environmental stressors in human epidermal keratinocytes and skin.,"OBJECTIVE


To evaluate whether niacinamide (Nam) can mitigate production of inflammatory and senescence-related biomarkers induced by environmental stressors.
METHODS


Human epidermal keratinocytes were exposed to UVB, urban dust, diesel exhaust and cigarette smoke extract and treated with Nam or vehicle control. Full thickness 3-D skin organotypic models were exposed to a combination of UVB and PM 2.5  and treated with Nam or vehicle control. Quantitation of the SASP-related inflammatory mediators PGE 2  , IL-6 and IL-8 was performed on cultured media. UVB-exposed keratinocytes treated with and without Nam were immunostained for the senescence biomarker Lamin B1 (LmnB1). Transcriptomics profiling of cigarette smoke extract effects on keratinocytes was performed. A double-blind, placebo-controlled clinical was conducted on 40 female panellists that were pretreated on back sites for two weeks with 5% Nam or vehicle and then exposed to 1.5 minimal erythemal dose (MED) solar-simulated radiation (SSR). Treated sites were compared with non-treated exposed sites for erythema and the skin surface IL-1αRA/IL-1α inflammatory biomarkers.
RESULTS


Ultraviolet B induced synthesis of PGE 2  , IL-8 and IL-6 and reduced LmnB1 levels in keratinocytes. Urban dust and diesel exhaust only stimulated synthesis of IL-8 whereas cigarette smoke extract only stimulated levels of PGE 2  . In all exposures, treatment with Nam significantly mitigated synthesis of the inflammatory mediators and restored levels of UVB-reduced LmnB1. In the 3D skin equivalent model, Nam reduced IL-8 levels stimulated by a combination of topical PM 2.5  and UV exposure. In a UV challenge clinical, pretreatment with 5% Nam reduced erythema and skin surface IL-1αRA/IL-1α inflammatory biomarkers that were induced by SSR.
CONCLUSION


Since it is known that Nam has anti-inflammatory properties, we tested whether Nam can inhibit environmental stress-induced inflammation and senescence-associated secretory phenotype (SASP) biomarkers. We show Nam can reduce PGE 2  , IL-6 and IL-8 levels induced by environmental stressors. Additionally, in vivo pretreatment with Nam can reduce UV-induced erythema and skin surface inflammatory biomarkers. These findings add to the body of evidence that Nam can mitigate the skin's inflammatory response elicited by environmental stressors. This supports Nam can potentially inhibit senescence and premature ageing and thereby maintain skin's functionality and appearance.",2020,"RESULTS


UVB induced synthesis of PGE 2  , IL-8 and IL-6 and reduced LmnB1 levels in keratinocytes.","['40 female panelists that were pretreated on back sites for two weeks with', 'Human epidermal keratinocytes were exposed to UVB, urban dust, diesel exhaust, and']","['niacinamide (Nam', 'cigarette smoke extract and treated with Nam or vehicle control', 'UVB and PM 2.5  and treated with Nam or vehicle control', '5% Nam or vehicle and then exposed to 1.5 minimal erythemal dose (MED) solar simulated radiation (SSR', 'placebo']","['synthesis of PGE 2  , IL-8 and IL-6 and reduced LmnB1 levels', 'PGE 2  , IL-6, and IL-8 levels', 'mitigated synthesis of the inflammatory mediators and restored levels of UVB-reduced LmnB1', 'IL-8 levels', 'erythema and skin surface IL-1αRA/IL-1α inflammatory biomarkers', 'UV-induced erythema and skin surface inflammatory biomarkers']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0022567', 'cui_str': 'Keratinocyte'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0013330', 'cui_str': 'Dust'}, {'cui': 'C0012151', 'cui_str': 'Diesel Exhaust'}]","[{'cui': 'C0028027', 'cui_str': 'Niacinamide'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0033559', 'cui_str': 'E series prostaglandin'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0454530', 'cui_str': 'Ultraviolet B therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",40.0,0.0491362,"RESULTS


UVB induced synthesis of PGE 2  , IL-8 and IL-6 and reduced LmnB1 levels in keratinocytes.","[{'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Bierman', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Laughlin', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Makio', 'Initials': 'M', 'LastName': 'Tamura', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Ben C', 'Initials': 'BC', 'LastName': 'Hulette', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Catherine E', 'Initials': 'CE', 'LastName': 'Mack', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Sherrill', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}, {'ForeName': 'Christina Y R', 'Initials': 'CYR', 'LastName': 'Tan', 'Affiliation': 'Skin Research Institute of Singapore, A*STAR, 8A Biomedical Grove, #06-06 Immunos, Singapore, 138648, Singapore.'}, {'ForeName': 'Malgorzata', 'Initials': 'M', 'LastName': 'Morenc', 'Affiliation': 'Skin Research Institute of Singapore, A*STAR, 8A Biomedical Grove, #06-06 Immunos, Singapore, 138648, Singapore.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bellanger', 'Affiliation': 'Skin Research Institute of Singapore, A*STAR, 8A Biomedical Grove, #06-06 Immunos, Singapore, 138648, Singapore.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Oblong', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, 45040, USA.'}]",International journal of cosmetic science,['10.1111/ics.12651']
1479,32615462,The effect of baclofen on objective and subjective sleep measures in a model of transient insomnia.,"STUDY OBJECTIVES


Insomnia is a common medical complaint. Current pharmacologic treatments have modest efficacy and numerous side effects. Baclofen is a gamma-aminobutyric acid (GABA)b receptor agonist used to treat spasticity in various medical conditions. Several studies noted that baclofen, when used to treat sleep related disorders, resulted in improvement in sleep parameters. Measures of insomnia, however, were not assessed in those studies. To date, baclofen has not been assessed for efficacy in the treatment of insomnia.
METHODS


We randomized 20 healthy subjects to baclofen or placebo in a cross over design. All subjects underwent two polysomnograms (PSG) assessing sleep parameters. Baclofen or placebo was given 90 min prior to lights out in random order for each subject. Lights out occurred two hours earlier than the subject's median habitual bedtime.
RESULTS


Baclofen resulted in significantly less objective wake after sleep onset and stage 1 sleep, and significantly increased total sleep time (TST), sleep efficiency, and stage 3/4 sleep. There was no effect on sleep onset latency (SOL). Self-report variables indicated significantly less subjective awakenings from sleep and increased subjective sleep quality. There was no effect on subjective TST or subjective SOL.
CONCLUSIONS


This study showed that baclofen was superior to placebo with regard to several objective and subjective measures used to assess sleep quality. These data support the notion that baclofen shows promise as an effective hypnotic drug.",2020,This study showed that baclofen was superior to placebo with regard to several objective and subjective measures used to assess sleep quality.,['20 healthy subjects to'],"['baclofen', 'baclofen or placebo', 'Baclofen or placebo', 'placebo']","['subjective awakenings from sleep and increased subjective sleep quality', 'sleep parameters', 'sleep onset latency (SOL', 'subjective TST or subjective SOL', 'total sleep time (TST), sleep efficiency, and stage 3/4 sleep', 'objective wake after sleep onset and stage 1 sleep', 'sleep quality', 'objective and subjective sleep measures']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",20.0,0.028149,This study showed that baclofen was superior to placebo with regard to several objective and subjective measures used to assess sleep quality.,"[{'ForeName': 'Samih', 'Initials': 'S', 'LastName': 'Raad', 'Affiliation': 'University of Oklahoma Health Sciences Center, Section of Pulmonary Critical Care & Sleep Medicine, Oklahoma City, OK, USA. Electronic address: Samih-Raad@ouhsc.edu.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Wilkerson', 'Affiliation': 'Lynn Health Science Institute, Oklahoma City, OK, USA. Electronic address: Meredith-Wilkerson@ouhsc.edu.'}, {'ForeName': 'Kellie R', 'Initials': 'KR', 'LastName': 'Jones', 'Affiliation': 'University of Oklahoma Health Sciences Center, Section of Pulmonary Critical Care & Sleep Medicine, Oklahoma City, OK, USA. Electronic address: Kellie-Jones@ouhsc.edu.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Orr', 'Affiliation': 'University of Oklahoma Health Sciences Center, Lynn Health Science Institute, Oklahoma City, OK, USA. Electronic address: worr@lhsi.net.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.028']
1480,32615473,Acceptance and commitment therapy combined with vestibular rehabilitation for persistent postural-perceptual dizziness: A pilot study.,"PURPOSE


This study investigated the feasibility of acceptance and commitment therapy for persistent postural-perceptual dizziness and preliminarily verified the long-term effectiveness of the therapy.
MATERIALS AND METHODS


This study implemented the within-group pre-post comparison design. We enrolled 27 adult patients who met the criteria of persistent postural-perceptual dizziness. They underwent a treatment program including acceptance and commitment therapy combined with vestibular rehabilitation once a week for a total of six sessions. The primary outcome was changes in the Dizziness Handicap Inventory score 6 months posttreatment.
RESULTS


All 27 patients completed the acceptance and commitment therapy + vestibular rehabilitation program, and 25 patients (92.6%) could be followed for 6 months posttreatment. For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42). At 6 months posttreatment, 11 patients (40.7%) achieved remission (the score ≤ 14), 16 (59.3%) achieved treatment response (reduction in the score ≥ 18), and 20 (74.1%) achieved remission and/or treatment response.
CONCLUSIONS


Acceptance and commitment therapy is feasible for persistent postural-perceptual dizziness and might have long-term effectiveness. However, a randomized controlled trial is warranted.",2020,"For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42).","['persistent postural-perceptual dizziness', '27 adult patients who met the criteria of persistent postural-perceptual dizziness']","['Acceptance and commitment therapy combined with vestibular rehabilitation', 'acceptance and commitment therapy', 'acceptance and commitment therapy combined with vestibular rehabilitation']","['Dizziness Handicap Inventory effect size', 'remission', 'Dizziness Handicap Inventory score 6\xa0months posttreatment', 'remission and/or treatment response']","[{'cui': 'C0522360', 'cui_str': 'Persistent postural perceptual dizziness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4304791', 'cui_str': 'Dizziness Handicap Inventory score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",27.0,0.176719,"For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42).","[{'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: jurry7777@hotmail.co.jp.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: kondo-masaki@umin.ac.jp.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Kabaya', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: kabaya@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Wakako', 'Initials': 'W', 'LastName': 'Watanabe', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Kikuchi Mental Clinic, Ushikubo-cho, Toyokawa 442-0826, Japan. Electronic address: wakakoigarashi@gmail.com.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: fecitanno@gmail.com.'}, {'ForeName': 'Mie', 'Initials': 'M', 'LastName': 'Sakai', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: mie.sakai.38@gmail.com.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Toshishige', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: yuu0323uchi@yahoo.co.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ino', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: miniture_flute@hotmail.com.'}, {'ForeName': 'Meiho', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Good Sleep Center, Nagoya City University Hospital, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: nakayama@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: iwashin-tky@umin.ac.jp.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: takechi@med.nagoya-cu.ac.jp.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102609']
1481,32617609,Anterolateral ligament reconstruction improves the clinical and functional outcomes of anterior cruciate ligament reconstruction in athletes.,"PURPOSE


To compare the outcomes of anterior cruciate ligament (ACL) reconstruction with those of combined ACL and anterolateral ligament (ALL) reconstruction in ACL-deficient knees. The objective of this study was to improve knowledge regarding the treatment of ACL-deficient knees with combined ACL and ALL reconstruction. Combined ACL and ALL reconstruction has been hypothesized to result in better clinical and functional outcomes than isolated ACL reconstruction (ACLR).
METHODS


One-hundred and seven adult male athletes with ACL tears and high-grade pivot shifts were randomized into two groups. Those in group A (n = 54) underwent ACLR, while those in group B (n = 53) underwent combined ACL and ALL reconstruction. The median age was 26 (18-40) and 24 (18-33) years in groups A and B, respectively, and the median follow-up was 60 (55-65) months. Physical examination findings, instrumented knee laxity tested using a KT-1000 arthrometer, and International Knee Documentation Committee Scale (IKDC) scores were used to evaluate the outcomes.
RESULTS


One-hundred and two patients were available for follow-up: 52 in group A and 50 in group B. Postoperatively, the pivot shift was normal in 43 (82.7%) and 48 (96%) patients in groups A and B, respectively (p < 0.001). The median instrumented knee laxity was 2.5 ± 0.7 (1.2-6.1) mm in patients in group A and 1.2 ± 0.7 (1.2-3.2) mm in patients in group B (p < 0.001). Additionally, 44 (84.6%) patients in group A had normal IKDC scores and 3 (5.8%) had nearly normal scores, while 48 (96.0%) patients in group B had normal IKDC scores and 2 (4%) had nearly normal scores (p < 0.001).
CONCLUSION


Combined ACL and ALL reconstruction, compared with isolated ACLR resulted in favourable clinical and functional outcomes, as demonstrated by decreased rotational instability and instrumented knee laxity, a lower graft rupture rate and better postoperative IKDC scores.
LEVEL OF EVIDENCE


1.",2020,"RESULTS


One-hundred and two patients were available for follow-up: 52 in group A and 50 in group B. Postoperatively, the pivot shift was normal in 43 (82.7%) and 48 (96%) patients in groups A and B, respectively (p < 0.001).","['One-hundred and seven adult male athletes with ACL tears and high-grade pivot shifts', 'ACL-deficient knees', 'anterior cruciate ligament reconstruction in athletes']","['ACL-deficient knees with combined ACL and ALL reconstruction', 'Anterolateral ligament reconstruction', 'combined ACL and ALL reconstruction', 'anterior cruciate ligament (ACL) reconstruction with those of combined ACL and anterolateral ligament (ALL) reconstruction', 'Combined ACL and ALL reconstruction', 'ACLR']","['favourable clinical and functional outcomes', 'Physical examination findings, instrumented knee laxity tested using a KT-1000 arthrometer, and International Knee Documentation Committee Scale (IKDC) scores', 'rotational instability and instrumented knee laxity, a lower graft rupture rate and better postoperative IKDC scores', 'pivot shift', 'normal IKDC scores', 'normal scores', 'median instrumented knee laxity']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0547071', 'cui_str': 'Ligament reconstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0183894', 'cui_str': 'Arthrometer'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",107.0,0.0302006,"RESULTS


One-hundred and two patients were available for follow-up: 52 in group A and 50 in group B. Postoperatively, the pivot shift was normal in 43 (82.7%) and 48 (96%) patients in groups A and B, respectively (p < 0.001).","[{'ForeName': 'Fawzy', 'Initials': 'F', 'LastName': 'Hamido', 'Affiliation': 'Division of Sports Medicine, Al-Razi Orthopaedic Hospital, Ministry of Health, Kuwait, Kuwait. fhf19633@yahoo.com.'}, {'ForeName': 'Abdelrahman A', 'Initials': 'AA', 'LastName': 'Habiba', 'Affiliation': 'Division of Sports Medicine, Al-Razi Orthopaedic Hospital, Ministry of Health, Kuwait, Kuwait.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Marwan', 'Affiliation': 'Division of Sports Medicine, Al-Razi Orthopaedic Hospital, Ministry of Health, Kuwait, Kuwait.'}, {'ForeName': 'Aymen S I', 'Initials': 'ASI', 'LastName': 'Soliman', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Tarek A', 'Initials': 'TA', 'LastName': 'Elkhadrawe', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Mohamed G', 'Initials': 'MG', 'LastName': 'Morsi', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Shoaeb', 'Affiliation': 'Division of Sports Medicine, Al-Razi Orthopaedic Hospital, Ministry of Health, Kuwait, Kuwait.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Nagi', 'Affiliation': 'Division of Sports Medicine, Al-Razi Orthopaedic Hospital, Ministry of Health, Kuwait, Kuwait.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06119-w']
1482,32618695,Acute Kidney Injury in Acute Ischemic Stroke Patients in Clinical Trials.,"OBJECTIVES


Acute ischemic stroke patients are at risk of acute kidney injury due to volume depletion, contrast exposure, and preexisting comorbid diseases. We determined the occurrence rate and identified predictors associated with acute kidney injury in acute ischemic stroke patients.
SETTING


Multiple specialized ICUs within academic medical centers.
DESIGN


Post hoc analysis of pooled data from prospective randomized clinical trials.
PATIENTS


Acute ischemic stroke patients recruited within 3 hours or within 5 hours of symptom onset.
INTERVENTIONS


IV recombinant tissue plasminogen activator, endovascular treatment, IV albumin, or placebo.
MEASUREMENTS AND MAIN RESULTS


Serum creatinine levels from baseline and within day 5 or discharge were used to classify acute kidney injury classification into stages. Any increase in serum creatinine was seen in 697 (36.1%) and acute kidney injury was seen in 68 (3.5%) of 1,931 patients with acute ischemic stroke. Severity of acute kidney injury was grade I, II, and III in 3.1%, 0.4%, and 0.05% patients, respectively. Patients with albumin (5.5% compared with 2.6%; p = 0.001), preexisting hypertension (4.3% compared with 1.5%; p = 0.0041), and preexisting renal disease (9.1% compared with 3.0%; p < 0.0001) had higher risk of acute kidney injury. The risk of acute kidney injury was lower between those who either underwent CT angiography (2.0% compared with 4.7%; p = 0.0017) or endovascular treatment (1.6% compared with 4.2%; p = 0.0071). In the multivariate analysis, hypertension (odds ratio, 2.6; 95% CI, 1.2-5.6) and renal disease (odds ratio, 3.5; 95% CI, 1.9-6.5) were associated with acute kidney injury. The risk of death was significantly higher among patients with acute kidney injury (odds ratio, 2.7; 95% CI, 1.4-4.9) after adjusting for age and National Institutes of Health Stroke Scale score strata.
CONCLUSIONS


The occurrence rate of acute kidney injury in acute ischemic stroke patients was low and was not higher in patients who underwent CT angiogram or those who received endovascular treatment. Occurrence of acute kidney injury increased the risk of death within 3 months among acute ischemic stroke patients.",2020,"In the multivariate analysis, hypertension (odds ratio, 2.6; 95% CI, 1.2-5.6) and renal disease (odds ratio, 3.5; 95% CI, 1.9-6.5) were associated with acute kidney injury.","['1,931 patients with acute ischemic stroke', 'Multiple specialized ICUs within academic medical centers', 'Acute Ischemic Stroke Patients', 'acute ischemic stroke patients', 'Acute ischemic stroke patients recruited within 3 hours or within 5 hours of symptom onset', 'Acute ischemic stroke patients']","['CT angiography', 'recombinant tissue plasminogen activator, endovascular treatment, IV albumin, or placebo', 'CT angiogram']","['preexisting renal disease', 'risk of death', 'serum creatinine', 'renal disease', 'Serum creatinine levels', 'acute kidney injury', 'preexisting hypertension', 'risk of acute kidney injury']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C1442467', 'cui_str': '5 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",1931.0,0.150194,"In the multivariate analysis, hypertension (odds ratio, 2.6; 95% CI, 1.2-5.6) and renal disease (odds ratio, 3.5; 95% CI, 1.9-6.5) were associated with acute kidney injury.","[{'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Department of Neurology, Zeenat Qureshi Stroke Institute, St. Cloud, MN.'}, {'ForeName': 'Hunain', 'Initials': 'H', 'LastName': 'Aslam', 'Affiliation': 'Department of Neurology, Zeenat Qureshi Stroke Institute, St. Cloud, MN.'}, {'ForeName': 'Werdah', 'Initials': 'W', 'LastName': 'Zafar', 'Affiliation': 'Department of Neurology, Zeenat Qureshi Stroke Institute, St. Cloud, MN.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Zeenat Qureshi Stroke Institute, St. Cloud, MN.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Lobanova', 'Affiliation': 'Department of Neurology, Zeenat Qureshi Stroke Institute, St. Cloud, MN.'}, {'ForeName': 'Syed H', 'Initials': 'SH', 'LastName': 'Naqvi', 'Affiliation': 'Department of Medicine, University of Missouri, Columbia, MO.'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Malhotra', 'Affiliation': 'Department of Medicine, University of Missouri, Columbia, MO.'}, {'ForeName': 'Niraj', 'Initials': 'N', 'LastName': 'Arora', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, MO.'}, {'ForeName': 'Premkumar N', 'Initials': 'PN', 'LastName': 'Chandrasekaran', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, MO.'}, {'ForeName': 'Farhan', 'Initials': 'F', 'LastName': 'Siddiq', 'Affiliation': 'Division of Neurosurgery, Department of Surgery, University of Missouri, Columbia, MO.'}, {'ForeName': 'Brandi R', 'Initials': 'BR', 'LastName': 'French', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, MO.'}, {'ForeName': 'Camilo R', 'Initials': 'CR', 'LastName': 'Gomez', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, MO.'}]",Critical care medicine,['10.1097/CCM.0000000000004464']
1483,32618713,"Antenatal Uterotonics as a Risk Factor for Intrapartum Stillbirth and First-day Death in Haryana, India: A Nested Case-control Study.","BACKGROUND


Use of uterotonics like oxytocin to induce or augment labor has been shown to reduce placental perfusion and oxygen supply to the fetus, and studies indicate that it may increase the risk of stillbirth and neonatal asphyxia. Antenatal use of uterotonics, even without the required fetal monitoring and prompt access to cesarean section, is widespread, yet no study has adequately estimated the risk of intrapartum stillbirth and early neonatal deaths ascribed to such use. We conducted a case-control study to estimate this risk.
METHODS


We conducted a population-based case-control study nested in a cluster-randomized trial. From 2008 to 2010, we followed pregnant women in rural Haryana, India, monthly until delivery. We visited all live-born infants on day 29 to ascertain whether they were alive. We conducted verbal autopsies for stillbirths and neonatal deaths. Cases (n = 2,076) were the intrapartum stillbirths and day-1 deaths (early deaths), and controls (n = 532) were live-born babies who died between day 8 and 28 (late deaths).
RESULTS


Antenatal administration of uterotonics preceded 74% of early and 62% of late deaths, translating to an adjusted odds ratio (95% confidence interval [CI]) for early deaths of 1.7 (95% CI = 1.4, 2.1), and a population attributable risk of 31% (95% CI = 22%, 38%).
CONCLUSIONS


Antenatal administration of uterotonics was associated with a substantially increased risk of intrapartum stillbirth and day-1 death. See video abstract: http://links.lww.com/EDE/B707.",2020,"CONCLUSIONS


Antenatal administration of uterotonics was associated with a substantially increased risk of intrapartum stillbirth and day-1 death.","['From 2008 to 2010, we followed pregnant women in rural Haryana, India, monthly until delivery']",[],"['risk of intrapartum stillbirth and day-1 death', 'intrapartum stillbirths and day-1 deaths (early deaths']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1720302', 'cui_str': 'Until'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",,0.117976,"CONCLUSIONS


Antenatal administration of uterotonics was associated with a substantially increased risk of intrapartum stillbirth and day-1 death.","[{'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Brahmawar Mohan', 'Affiliation': 'From the Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}, {'ForeName': 'Halvor', 'Initials': 'H', 'LastName': 'Sommerfelt', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health (CISMAC) and Centre for International Health (CIH), University of Bergen, Bergen, Norway.'}, {'ForeName': 'J Frederik', 'Initials': 'JF', 'LastName': 'Frøen', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health (CISMAC) and Centre for International Health (CIH), University of Bergen, Bergen, Norway.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'From the Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}, {'ForeName': 'Tivendra', 'Initials': 'T', 'LastName': 'Kumar', 'Affiliation': 'From the Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Bhatia', 'Affiliation': 'From the Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}, {'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'van der Merwe', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health (CISMAC) and Centre for International Health (CIH), University of Bergen, Bergen, Norway.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': 'Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Martines', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health (CISMAC) and Centre for International Health (CIH), University of Bergen, Bergen, Norway.'}, {'ForeName': 'Sarmila', 'Initials': 'S', 'LastName': 'Mazumder', 'Affiliation': 'From the Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Bhandari', 'Affiliation': 'From the Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}]","Epidemiology (Cambridge, Mass.)",['10.1097/EDE.0000000000001224']
1484,32619792,Human urine  1 H NMR metabolomics reveals alterations of the protein and carbohydrate metabolism when comparing habitual Average Danish diet vs. healthy New Nordic diet.,"OBJECTIVES


The aim of this study was to investigate the alteration of the human urine metabolome by means of diet and to compare the metabolic effects of the nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD). The NND was designed a decade ago by scientists and chefs, based on local and sustainable foods, including fish, shellfish, vegetables, roots, fruit, and berries. The NND has been proven to lower blood pressure, reduce glycemia, and lead to weight loss.
METHODS


The human urine metabolome was measured by untargeted proton nuclear magnetic resonance spectroscopy in samples from 142 centrally obese Danes (20-66 years old), randomized to consume the ADD or the NND. The resulting metabolomics data was processed and analyzed using advanced multivariate data analysis methods to reveal effects related to the design factors, including diet, season, sex, and changes in body weight.
RESULTS


Exploration of the nuclear magnetic resonance profiles revealed unique metabolite markers reflecting changes in protein and carbohydrate metabolism between the two diets. Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased. Propylene glycol had a strong association with the homeostatic model assessment for insulin resistance in the NND group. The food intake biomarkers found in this study confirm the importance of these as tools for nutritional research.
CONCLUSIONS


Findings from this study provided new insights into the effects of a healthy diet on glycemia, reduction of inflammation, and weight loss among obese individuals, and alteration of the gut microbiota metabolism.",2020,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.",['in samples from 142 centrally obese Danes (20-66 years old'],"['nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD', 'Propylene glycol', 'untargeted proton nuclear magnetic resonance spectroscopy']","['relative concentrations of tartrate, dimethyl sulfone, and propylene glycol', 'glycemia, reduction of inflammation, and weight loss', 'Glycine betaine, glucose, trimethylamine N-oxide and creatinine']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0337800', 'cui_str': 'Danes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0877853', 'cui_str': 'Spectroscopy, NMR'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039328', 'cui_str': 'Tartrates'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",142.0,0.027383,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.","[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Trimigno', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bekzod', 'Initials': 'B', 'LastName': 'Khakimov', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Savorani', 'Affiliation': 'Department of Applied Science and Technology, Polytechnic of Turin, Turin, Italy.'}, {'ForeName': 'Sanne Kellebjerg', 'Initials': 'SK', 'LastName': 'Poulsen', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars O', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren Balling', 'Initials': 'SB', 'LastName': 'Engelsen', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark. Electronic address: se@food.ku.dk.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110867']
1485,32619832,Definitive chemoradiotherapy plus cetuximab for cancer in the oesophagus or gastro-oesophageal junction.,"BACKGROUND


Chemoradiotherapy is standard treatment for localized oesophageal cancer unsuitable for surgery. We aimed to evaluate the efficacy of cetuximab in combination with chemoradiotherapy.
METHODS


This non-randomised multicentre phase II trial recruited patients aged 18-75 with WHO performance status 0-2 having squamous cell carcinoma or adenocarcinoma in the oesophagus or gastro-oesophageal junction, T2-4, N0-3, M0 not suitable for surgery. Chemotherapy was three 21-day cycles of fluorouracil 750 mg/m2 D1-5 and oxaliplatin D1 (cycle 1:130mg/m 2, cycle 2-3:85 mg/m 2). Radiotherapy was 50Gy in 2Gy/fraction, 5 days a week, concurrent with cycle 2 and 3 and weekly cetuximab. The primary objective was loco-regional control at one year.
RESULTS


52 patients were included. 51 were eligible for toxicity and survival analysis and 46 for recurrence analysis. Full radiotherapy dose was delivered to 80%, 75% received all three cycles of chemotherapy and 75% received four or more doses of cetuximab. The most common related grade III-IV adverse events were gastro-intestinal(16), hypersensitivity(6) and infection(5). There were two drug-related deaths. Within six months from the end of treatment, six patients died from complications from fistulas. The loco-regional control rate at one year was 47.3%(95%CI 30.9%-62.1%). Overall survival at three years was 29.1%(95% CI 17.4-41.9%).
CONCLUSIONS


Oxaliplatin and fluorouracil given concurrent with radiotherapy and cetuximab had an acceptable safety profile and showed a clinical response in patients with locoregionally advanced oesophageal cancer unsuitable for surgery. However, the primary end-point was not met, and the addition of cetuximab to definitive chemoradiotherapy cannot be recommended.",2020,"Overall survival at three years was 29.1%(95% CI 17.4-41.9%).
","['localized oesophageal cancer unsuitable for surgery', 'cancer in the oesophagus or gastro-oesophageal junction', 'patients with locoregionally advanced oesophageal cancer unsuitable for surgery', 'patients aged 18-75 with WHO performance status 0-2 having squamous cell carcinoma or adenocarcinoma in the oesophagus or gastro-oesophageal junction, T2-4, N0-3, M0 not suitable for surgery', '52 patients were included']","['radiotherapy and cetuximab', 'Chemotherapy', 'Definitive chemoradiotherapy plus cetuximab', 'Oxaliplatin and fluorouracil', 'Full radiotherapy', 'cetuximab', 'Chemoradiotherapy', 'fluorouracil 750 mg/m2 D1-5 and oxaliplatin D1 (cycle 1:130mg', 'Radiotherapy']","['toxicity and survival analysis', 'Overall survival', 'loco-regional control at one year', 'loco-regional control rate']","[{'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0546837', 'cui_str': 'Malignant tumor of esophagus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",52.0,0.16028,"Overall survival at three years was 29.1%(95% CI 17.4-41.9%).
","[{'ForeName': 'Gabriella Alexandersson', 'Initials': 'GA', 'LastName': 'von Döbeln', 'Affiliation': 'Theme Cancer, Karolinska University Hospital, Stockholm, Sweden. Electronic address: gabriella.alexandersson-vondobeln@sll.se.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Wagenius', 'Affiliation': 'Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Holtved', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Anne-Birgitte', 'Initials': 'AB', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Oncology, Oslo University hospital, Oslo, Norway.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Department of Clinical Sciences Intervention and Technology Karolinska Institutet Division of Upper Abdominal Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jingru', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Baeksgaard', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2020.100187']
1486,32621630,A Mindfulness-Based Intervention as a Supportive Care Strategy for Patients with Metastatic Non-Small Cell Lung Cancer and Their Spouses: Results of a Three-Arm Pilot Randomized Controlled Trial.,"BACKGROUND


Although mindfulness-based interventions have been widely examined in patients with nonmetastatic cancer, the feasibility and efficacy of these types of programs are largely unknown for those with advanced disease. We pilot-tested a couple-based meditation (CBM) relative to a supportive-expressive (SE) and a usual care (UC) arm targeting psychospiritual distress in patients with metastatic lung cancer and their spousal caregivers.
PATIENTS AND METHODS


Seventy-five patient-caregiver dyads completed baseline self-report measures and were then randomized to one of the three arms. Couples in the CBM and SE groups attended four 60-minute sessions that were delivered via videoconference. All dyads were reassessed 1 and 3 months later.
RESULTS


A priori feasibility benchmarks were met. Although attendance was high in both groups, dyads in the CBM group indicated greater benefit of the sessions than those in the SE group (patients, CBM mean = 2.63, SE mean = 2.20, p = .003; spouses, CBM mean = 2.71, SE mean = 2.00, p = .005). Compared with the UC group, patients in the CBM group reported significantly lower depressive symptoms (p = .05; d = 0.53) and marginally reduced cancer-related stress (p = .07; d = 0.68). Medium effect sizes in favor of the CBM compared with the SE group for depressive symptoms (d = 0.59) and cancer-related stress (d = 0.54) were found. Spouses in the CBM group reported significantly lower depressive symptoms (p < .01; d = 0.74) compared with those in the UC group.
CONCLUSION


It seems feasible and possibly efficacious to deliver dyadic interventions via videoconference to couples coping with metastatic lung cancer. Mindfulness-based interventions may be of value to managing psychological symptoms in the palliative care setting. Clinical trial identification number. NCT02596490 IMPLICATIONS FOR PRACTICE: The current randomized controlled trial has established that a mindfulness approach to the management of patients' and spouses' psychospiritual concerns is acceptable and subjectively deemed more beneficial than a supportive-expressive treatment for patients with metastatic non-small cell lung cancer (NSCLC). We also revealed that videoconference delivery, here FaceTime, is an acceptable approach even for geriatric patients with metastatic NSCLC and that patients and their spousal caregivers prefer a dyadic delivery of this type of supportive care strategy. Lastly, this trial has laid the foundation for the role of mindfulness-based interventions in the palliative care setting supporting patients with advanced NSCLC and their spousal caregivers.",2020,"Spouses in the CBM group reported significantly lower depressive symptoms (P<.01; d=.74) compared with those in the UC group.
","['patients with metastatic lung cancer and their spousal caregivers', 'patients with non-metastatic cancer', 'Patients with Metastatic Non-Small Cell Lung Cancer and their Spouses', 'Seventy-five patient-caregiver dyads completed baseline self-report measures']","['SE', 'couple-based mediation (CBM) relative to a supportive-expressive (SE) and a usual care (UC) arm targeting psycho-spiritual distress', 'UC', 'CBM']",['depressive symptoms'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0150081', 'cui_str': 'Spiritual distress'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0403801,"Spouses in the CBM group reported significantly lower depressive symptoms (P<.01; d=.74) compared with those in the UC group.
","[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Milbury', 'Affiliation': 'Department\u2009of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Yisheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department\u2009of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Sania', 'Initials': 'S', 'LastName': 'Durrani', 'Affiliation': 'Department\u2009of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department\u2009of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Tsao', 'Affiliation': 'Department\u2009of Head and Neck/Thoracic Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Carmack', 'Affiliation': 'Department\u2009of Palliative, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department\u2009of Palliative, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department\u2009of Palliative, Rehabilitation, and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}]",The oncologist,['10.1634/theoncologist.2020-0125']
1487,32627683,Does the initial level of horizontal force determine the magnitude of improvement in acceleration performance in rugby?,"This study aimed to observe the effect of 8 weeks of resisted sled training (RST), with optimal loading for maximal power output production and initial levels of force, on the magnitude of improvement in sprint performance and individual sprint mechanical outputs in female amateur rugby union players. The study examined the horizontal Power-Force-Velocity profile (P-F-V profile), which provides a measure of the athlete's individual balance between force and velocity capabilities (S fv ), theoretical maximum force (F 0 ), theoretical maximum velocity (V 0 ), maximum power (P max ), the maximum ratio of force (Rf max ) and rate of decrease in ratio of force (D rf ). Thirty-one participants (age = 23.7 ± 3.3years, BM = 69 ± 9Kg, height = 167.5 ± 5.2   cm) were divided into a control group and two experimental groups; forwards (FG) and backs (BG). For 8 consecutive weeks (16 sessions), all groups performed the same training programme: 2 sets of 5 ×   30   m, but athletes assigned to FG and BG ran towing a resisted sled attached to their waists, with optimal loading for maximal power output production. Both FG and BG significantly improved ( p  ≤ 0.05) in 5 and 20   m sprint performance, and in the mechanical properties related to the horizontal P-F-V profile. The correlation between the initial level of horizontal strength and the magnitude of improvement in P max  also suggests that higher levels of horizontal force may lead to greater adaptations in RST. The P-F-V profile is a useful field method for identifying the weakest mechanical variable in rugby players during sprinting and enabling the prescription of individualized raining programmes according to specific running performance.  Highlights  The optimal loading for maximal power output production, for RST, is an effective way to improve sprint performance in 5 m and 20 m, besides the underline mechanical variables associated to sprint performance in amateur female rugby players. Players with higher levels of horizontal force (sprint performance) may develop greater adaptations in RST than players with high levels of vertical force application (CMJ). The RST may develop specific adaptations to the contextual requirements of rugby, due to the transference of similar patterns of movement during acceleration skills and consequently, the enhancement of mechanical properties. The horizontal Power-Force-Velocity profile is a useful and approachable field method to monitor changes in mechanical variables during the sprinting performance and to assess the effectiveness of prescribed training.",2020,"Both FG and BG significantly improved (p≤0.05) in 5 m and 20 m sprint performance, and in the mechanical properties related to the horizontal P-F-V profile.","['Thirty-one participants (age=23.7\u2009±\u20093.3years, BM=69\u2009±\u20099Kg, height=167.5\u2009±\u20095.2\u2005cm', 'female amateur rugby union players']","['resisted sled training (RST', 'FG and BG ran towing a resisted sled attached to their waists, with optimal loading for maximal power output production']","['velocity capabilities (S fv ), theoretical maximum force (F 0 ), theoretical maximum velocity (V 0 ), maximum power (P max ), the maximum ratio of force (Rf max ) and rate of decrease in ratio of force (D rf ', 'horizontal Power-Force-Velocity profile']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}]","[{'cui': 'C0336980', 'cui_str': 'Sledding'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0445194', 'cui_str': 'Power output'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}]",31.0,0.0231945,"Both FG and BG significantly improved (p≤0.05) in 5 m and 20 m sprint performance, and in the mechanical properties related to the horizontal P-F-V profile.","[{'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Escobar Álvarez', 'Affiliation': 'Faculty of Higher Education, South Essex College University Centre, Southend on the Sea, UK.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Jiménez Reyes', 'Affiliation': 'Centre for Sports Studies, Rey Juan Carlos University, Madrid, Spain.'}, {'ForeName': 'Filipe Almeida', 'Initials': 'FA', 'LastName': 'Da Conceição', 'Affiliation': 'Centro Inovação Formação Investigação em Desporto, Faculdade Desporto, Porto, Portugal.'}, {'ForeName': 'Juan Pedro', 'Initials': 'JP', 'LastName': 'Fuentes García', 'Affiliation': 'Faculty of Sport Science, University of Extremadura, Cáceres, Spain.'}]",European journal of sport science,['10.1080/17461391.2020.1793004']
1488,32622784,A Thorough QT Study of the Combination Glecaprevir + Pibrentasvir on Cardiac Repolarization in Healthy Subjects.,"PURPOSE


Fixed-dose combination glecaprevir (GLE) 300 mg + pibrentasvir (PIB) 120 mg is an orally administered once daily antiviral regimen approved for the treatment of hepatitis C virus (HCV) infection. The objective of this study was to evaluate the potential for cardiac repolarization following GLE + PIB administration in healthy adults.
METHODS


This placebo- and active-controlled, randomized, single-dose, 4-period, 4-sequence crossover study enrolled 48 healthy subjects. The doses of GLE 400 mg + PIB 120 mg were selected to provide exposures comparable to those with the doses that are therapeutic in the HCV-infected population, GLE 300 mg + PIB 120 mg. The doses of GLE 600 mg + PIB 240 mg were selected to provide supratherapeutic exposures without exceeding the exposures of the GLE + PIB maximal tolerated doses. Moxifloxacin 400 mg (active control/open label) was used for confirming the sensitivity of the ECG assay in detecting QTc prolongation. Time-matched plasma concentrations and triplicate ECGs were obtained on treatment days -1 and 1. The primary end point was time-matched, placebo-corrected, baseline-adjusted Fridericia-corrected QT interval (ΔΔQTcF). Pharmacokinetic-pharmacodynamic analyses characterized the relationship between GLE and PIB plasma concentrations and ΔΔQTcF using a linear regression model and linear mixed-effects model. Findings from categorical analyses of ECG-interval data were also summarized. Tolerability was evaluated through adverse-events monitoring, physical examination including vital sign measurements, ECGs, and laboratory tests.
FINDINGS


A total of 48 subjects (22 women [46%], 26 men [54%]), were enrolled in the study, and 47 subjects completed all 4 periods. None of the subjects had a change from baseline in QTcF interval of >30 msec or an absolute QTcF interval of >450 msec. Peak ΔΔQTcF values observed at 5 h postdose (T max ) were 2.9 msec (upper 95% confidence limit, 4.9 msec) with the therapeutic dose and 3.1 msec (upper 95% confidence limit, 5.1 msec) with the supratherapeutic dose, with both upper 95% confidence limits well below the 10-msec threshold. Assay sensitivity was confirmed by peak ΔΔQTcF in the positive control (12.8 ms at 2 h postdose). No statistically significant GLE or PIB concentration-dependent effects on ΔΔQTcF were observed. Headache and skin irritation from ECG electrodes were the most commonly reported AEs. No clinically significant vital sign measurements, ECG findings, or laboratory measurements were observed. There were no patterns of T- and U-wave morphologic abnormalities.
IMPLICATIONS


The fixed-dose combination regimen of GLE/PIB does not prolong the QTc interval. ClinicalTrials.gov identifier.",2020,None of the subjects had a change from baseline in QTcF interval of >30 msec or an absolute QTcF interval of >450 msec.,"['48 subjects (22 women [46%], 26 men [54%]), were enrolled in the study, and 47 subjects completed all 4 periods', 'healthy adults', '48 healthy subjects', 'Healthy Subjects']","['GLE', 'Combination Glecaprevir\xa0+ Pibrentasvir', 'GLE/PIB', '300\xa0mg\xa0+\xa0pibrentasvir (PIB', 'Fixed-dose combination glecaprevir (GLE', 'Moxifloxacin 400\xa0mg (active control/open label', 'GLE\xa0+\xa0PIB administration', 'placebo']","['Cardiac Repolarization', 'QTc interval', 'Assay sensitivity', 'Time-matched plasma concentrations and triplicate ECGs', 'vital sign measurements, ECG findings, or laboratory measurements', 'Peak ΔΔQTcF values', 'time-matched, placebo-corrected, baseline-adjusted Fridericia-corrected QT interval (ΔΔQTcF', 'GLE or PIB concentration', 'adverse-events monitoring, physical examination including vital sign measurements, ECGs, and laboratory tests', 'Headache and skin irritation', 'Tolerability']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4519536', 'cui_str': 'glecaprevir'}, {'cui': 'C4519575', 'cui_str': 'glecaprevir and pibrentasvir'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4519537', 'cui_str': 'pibrentasvir'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1126029', 'cui_str': 'moxifloxacin 400 MG'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0438154', 'cui_str': 'ECG finding'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C4519536', 'cui_str': 'glecaprevir'}, {'cui': 'C4519537', 'cui_str': 'pibrentasvir'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}]",48.0,0.174435,None of the subjects had a change from baseline in QTcF interval of >30 msec or an absolute QTcF interval of >450 msec.,"[{'ForeName': 'Rajneet K', 'Initials': 'RK', 'LastName': 'Oberoi', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, USA.'}, {'ForeName': 'Weihan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Data and Statistical Sciences, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Rosebraugh', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, USA.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Mensa', 'Affiliation': 'Infectious Diseases, AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Haoyu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Data and Statistical Sciences, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, USA. Electronic address: wei.liu@abbvie.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.05.009']
1489,32623343,"""Sushi roll"" technique for precise total tongue functional reconstruction using a pre-sutured femoral anterolateral myocutaneous flap.","OBJECTIVES


Reconstruction of the total tongue after cancer resection remains one of the challenges in head and neck surgery. Inadequate reconstruction after subtotal or total glossectomy defects leads to poor quality of life. The aim of this study was to explore an economical, practical and effective flap design for functional tongue reconstruction.
MATERIAL AND METHODS


Sixty patients were randomly divided into two groups, namely, a ""Sushi roll"" technique group (30 patients) and a conventional surgery group (30 patients). Then, the patients underwent total or subtotal tongue reconstruction. Swallowing function, speech intelligibility, cosmetic results, and quality of life were assessed with the appropriate scales. Outcomes were analysed, and a p-value <0.05 was considered significant.
RESULTS


The perioperative recovery of the ""Sushi roll"" group was superior to that of the conventional group. Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
CONCLUSION


The innovative ""Sushi roll"" anterolateral thigh myocutaneous flap approach for total tongue reconstruction creates a free neotongue tip with adequate volume and protuberance and causes minimal damage to the donor site, producing acceptable swallowing function and speech intelligibility.",2020,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","['head and neck surgery', 'Sixty patients']","['Sushi roll"" technique group', 'conventional surgery', 'Sushi roll"" technique', 'subtotal tongue reconstruction']","['speech intelligibility', 'swallowing function', 'Swallowing function, speech intelligibility, cosmetic results, and quality of life', 'perioperative recovery', 'cosmetic results']","[{'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0399188', 'cui_str': 'Tongue reconstruction'}]","[{'cui': 'C0037824', 'cui_str': 'Speech Intelligibility'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0201308,"Relative to patients in the conventional group, patients in the ""Sushi roll"" group showed significantly improved speech intelligibility (p = 0.025), cosmetic results (p < 0.001) and swallowing function (p < 0.001).
","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: drzhouxi0504@csu.edu.cn.'}, {'ForeName': 'Zhi-Jing', 'Initials': 'ZJ', 'LastName': 'He', 'Affiliation': 'Lecturer, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yu-Xiong', 'Initials': 'YX', 'LastName': 'Su', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, Faculty of Dentistry, the University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhao Jian', 'Initials': 'ZJ', 'LastName': 'Gong', 'Affiliation': 'Associate Professor, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}, {'ForeName': 'Han Jiang', 'Initials': 'HJ', 'LastName': 'Wu', 'Affiliation': 'Professor and Chief, Discipline of Oral & Maxillofacial Surgery, The Second Xiangya hospital, Central South University, Changsha, China.'}]",Oral oncology,['10.1016/j.oraloncology.2020.104866']
1490,32623367,"A Novel Narrative E-Writing Intervention for Parents of Children With Chronic Life-Threatening Illnesses: Protocol for a Pilot, Open-Label Randomized Controlled Trial.","BACKGROUND


A novel evidence-based Narrative e-Writing Intervention (NeW-I) has been developed and tested in Singapore to advance psychosociospiritual support for parents of children with chronic life-threatening illnesses. NeW-I is informed by an international systematic review and a Singapore-based qualitative inquiry on the lived experience of parental bereavement and supported by literature on anticipatory grief interventions for improving the holistic well-being of parent caregivers of seriously ill children.
OBJECTIVE


This study's aim was to provide an accessible platform, NeW-I-which is a strengths- and meaning-focused and therapist-facilitated mobile app and web-based counseling platform-that aims to enhance quality of life, spiritual well-being, hope, and perceived social support and reduce depressive symptoms, caregiver burden, and risk of complicated grief among parents of children with chronic life-threatening illnesses.
METHODS


The NeW-I therapist-facilitated web-based platform comprises a mobile app and a website (both of which have the same content and functionality). NeW-I has been implemented in Singapore as a pilot open-label randomized controlled trial comprising intervention and control groups. Both primary and secondary outcomes will be self-reported by participants through questionnaires. In collaboration with leading pediatric palliative care providers in Singapore, the trial aims to enroll 36 participants in each group (N=72), so that when allowing for 30% attrition at follow-up, the sample size will be adequate to detect a small effect size of 0.2 in the primary outcome measure, with 90% power and two-sided significance level of at least .05. The potential effectiveness of NeW-I and the accessibility and feasibility of implementing and delivering the intervention will be assessed.
RESULTS


Funding support and institutional review board approval for this study have been secured. Data collection started in January 2019 and is ongoing.
CONCLUSIONS


NeW-I aspires to enhance holistic pediatric palliative care services through a structured web-based counseling platform that is sensitive to the unique cultural needs of Asian family caregivers who are uncomfortable with expressing emotion even during times of loss and separation. The findings of this pilot study will inform the development of a full-scale NeW-I protocol and further research to evaluate the efficacy of NeW-I in Singapore and in other Asian communities around the world.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03684382; https://clinicaltrials.gov/ct2/show/NCT03684382.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17561.",2020,"BACKGROUND


A novel evidence-based Narrative e-Writing Intervention (NeW-I) has been developed and tested in Singapore to advance psychosociospiritual support for parents of children with chronic life-threatening illnesses.","['Parents of Children With Chronic Life-Threatening Illnesses', 'parents of children with chronic life-threatening illnesses', 'enroll 36 participants in each group (N=72']",['Narrative E-Writing Intervention'],[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.175167,"BACKGROUND


A novel evidence-based Narrative e-Writing Intervention (NeW-I) has been developed and tested in Singapore to advance psychosociospiritual support for parents of children with chronic life-threatening illnesses.","[{'ForeName': 'Andy Hau Yan', 'Initials': 'AHY', 'LastName': 'Ho', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Oindrila', 'Initials': 'O', 'LastName': 'Dutta', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Tan-Ho', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Toh Hsiang Benny', 'Initials': 'THB', 'LastName': 'Tan', 'Affiliation': 'School of Computer Science and Engineering, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Xinyi Casuarine', 'Initials': 'XC', 'LastName': 'Low', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Sashikumar', 'Initials': 'S', 'LastName': 'Ganapathy', 'Affiliation': 'Club Rainbow, Singapore, Singapore.'}, {'ForeName': 'Josip', 'Initials': 'J', 'LastName': 'Car', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Ringo Moon-Ho', 'Initials': 'RM', 'LastName': 'Ho', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Chun Yan', 'Initials': 'CY', 'LastName': 'Miao', 'Affiliation': 'School of Computer Science and Engineering, Nanyang Technological University, Singapore, Singapore.'}]",JMIR research protocols,['10.2196/17561']
1491,32624282,"Erratum to 'Ten-year Mortality, Disease Progression, and Treatment-related Side Effects in Men with Localised Prostate Cancer from the ProtecT Randomised Controlled Trial According to Treatment Received' [European Urology 77 (2020) 320-330].",,2020,,['Men with Localised Prostate Cancer'],[],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]",[],[],,0.0635376,,"[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Neal', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK Professor Emeritus of Surgical Oncology, Universities of Cambridge and Oxford, UK. Electronic address: David.Neal@nds.ox.ac.uk.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Jenny L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanor I', 'Initials': 'EI', 'LastName': 'Walsh', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Tim J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Mason', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bryant', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Prasad', 'Initials': 'P', 'LastName': 'Bollina', 'Affiliation': 'Department of Urology & Surgery, Western General Hospital, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Catto', 'Affiliation': 'Academic Urology Unit, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Doherty', 'Affiliation': 'Department of Urology, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillatt', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gnanapragasam', 'Affiliation': 'Academic Urology Group, Department of Surgery & Cambridge Urology Translational Research and Clinical Trials, Cambridge Biomedical Campus, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Holding', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK Professor Emeritus of Surgical Oncology, Universities of Cambridge and Oxford, UK.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Hughes', 'Affiliation': 'Department of Urology, Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Kockelbergh', 'Affiliation': 'Department of Urology, University Hospitals of Leicester, Leicester, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Kynaston', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Oxley', 'Affiliation': 'Department of Cellular Pathology, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Paul', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Paez', 'Affiliation': 'Department of Urology, Freeman Hospital, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Rosario', 'Affiliation': 'Department of Urology, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Rowe', 'Affiliation': 'Department of Urology, Southmead Hospital and Bristol Urological Institute, Bristol, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Staffurth', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Doug G', 'Initials': 'DG', 'LastName': 'Altman', 'Affiliation': 'Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Freddie C', 'Initials': 'FC', 'LastName': 'Hamdy', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK Professor Emeritus of Surgical Oncology, Universities of Cambridge and Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2020.05.030']
1492,32629226,Occurrence of c.976 G>T (p.Val326Leu) and c.452 G>A (p.Trp151Ter) variants in DHCR7 gene in population of polish women with recurrent miscarriage.,"INTRODUCTION


Recurrent miscarriage is a serious clinical problem that affects 1-5 % of all couples trying to conceive. Although the incidence of Smith-Lemli-Opitz Syndrome (SLOS, OMIM #270400), an autosomal recessive condition caused by variants in the DHCR7 gene, is very low, (1:83 000), the observed carrier frequency of DHCR7 gene variants in the Polish population is high, ranging from 1:24 to 1:31. It is possible that this carriage may be responsible for early pregnancy loss.
OBJECTIVES


The aim of the study is to determine the carrier frequency of the p c.976 G>T (p.Val326Leu) and c.452 G>A (p.Trp151Ter) variants in the DHCR7 gene in patients experiencing recurrent miscarriage.
METHODS


The study group included 480 patients: a study group of 380 with at least 2 miscarriages before the 20th week of pregnancy, and a control group of 100 who had not experienced miscarriage. The variants were identified by genotyping: c.976 G>T (p.Val326Leu) by the TaqMan® SNP Genotyping Assay system, and c.452 G>A (p.Trp151Ter) using the BfaI restriction enzyme. Statistical analysis was performed using R software.
RESULTS


No examples of c.976 G>T (p.Val326Leu) were found in either group. c.452 G>A (p.Trp151Ter) was found in 22 participants from the study group and 4 from the control group; however, this difference was not significant (Chi2 test p = 0.61).
CONCLUSIONS


Being a carrier of the c.976 G>T (p.Val326Leu) and c.452 G>A (p.Trp151Ter) variants in theDHCR7 gene is not a risk factor for recurrent miscarriage in the Polish population.",2020,A (p.Trp151Ter) variants in theDHCR7 gene is not a risk factor for recurrent miscarriage in the Polish population.,"['population of polish women with recurrent miscarriage', 'patients experiencing recurrent miscarriage', '480 patients: a study group of 380 with at least 2 miscarriages before the 20th week of pregnancy, and a control group of 100 who had not experienced miscarriage']","['Val326Leu) and c.452 G', 'G']",[],"[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0000809', 'cui_str': 'Recurrent miscarriage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1704407', 'cui_str': '100'}]",[],[],,0.0226355,A (p.Trp151Ter) variants in theDHCR7 gene is not a risk factor for recurrent miscarriage in the Polish population.,"[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Chrzanowska-Steglińska', 'Affiliation': 'Department of Fetal Medicine and Gynaecology, the Medical University of Lodz, Poland. Electronic address: marta.chrzanowska85@interia.pl.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Moczulska', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland; Clinical Genetics Clinic, Central Clinical Hospital of the Medical University of Lodz, Poland.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Skoczylas', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Pietrusiński', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Antosik', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Jakiel', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Kacprzak', 'Affiliation': 'Department of Fetal Medicine and Gynaecology, the Medical University of Lodz, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Borowiec', 'Affiliation': 'Department of Clinical and Laboratory Genetics, the Medical University of Lodz, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Sieroszewski', 'Affiliation': 'Department of Fetal Medicine and Gynaecology, the Medical University of Lodz, Poland.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.063']
1493,32629295,Transcatheter InterAtrial Shunt Device for the treatment of heart failure: Rationale and design of the pivotal randomized trial to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP-HF II).,"BACKGROUND


A randomized, sham-controlled trial in patients with heart failure (HF) and left ventricular ejection fraction (LVEF) ≥40% demonstrated reductions in pulmonary capillary wedge pressure (PCWP) with a novel transcatheter InterAtrial Shunt Device (IASD). Whether this hemodynamic effect will translate to an improvement in cardiovascular outcomes and symptoms requires additional study.
STUDY DESIGN AND OBJECTIVES


REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure II (REDUCE LAP HF-II) is a multicenter, prospective, randomized, sham-controlled, blinded trial designed to evaluate the clinical efficacy of the IASD in symptomatic HF and elevated left atrial pressures. Up to 608 HF patients age ≥ 40 years with LVEF ≥40%, PCWP ≥25 mm Hg during supine ergometer exercise, and PCWP ≥5 mm Hg higher than right atrial pressure will be randomized 1:1 to the IASD versus sham control. Key exclusion criteria include hemodynamically significant valvular disease, evidence of pulmonary arterial hypertension, and right heart dysfunction. The primary endpoint is a hierarchical composite, analyzed by the Finkelstein-Schoenfeld methodology, that includes (1) cardiovascular mortality or first nonfatal ischemic stroke through 12 months; (2) total (first plus recurrent) HF hospitalizations or healthcare facility visits for intravenous diuretics up to 24 months, analyzed when the last randomized patient completes 12 months of follow-up; and (3) change in Kansas City Cardiomyopathy Questionnaire overall summary score from baseline to 12 months. Follow-up echocardiography will be performed at 6, 12, and 24 months to evaluate shunt flow and cardiac chamber size/function. Patients will be followed for a total of 5 years after the index procedure.
CONCLUSIONS


REDUCE LAP-HF II is designed to evaluate the clinical efficacy of the IASD device in patients with symptomatic HF with elevated left atrial pressure and LVEF ≥40%.",2020,≥40% demonstrated reductions in pulmonary capillary wedge pressure (PCWP) with a novel transcatheter InterAtrial Shunt Device (IASD).,"['608 HF patients age', 'Patients with Heart Failure II', 'heart failure', 'patients with heart failure (HF) and left ventricular ejection fraction (LVEF', 'patients with symptomatic HF with elevated left atrial pressure and LVEF ≥40']","['novel transcatheter InterAtrial Shunt Device (IASD', 'LVEF', 'supine ergometer exercise, and PCWP ≥5', 'Transcatheter InterAtrial Shunt Device', 'IASD']","['HF hospitalizations or healthcare facility visits', 'Kansas City Cardiomyopathy Questionnaire overall summary score', 'pulmonary capillary wedge pressure (PCWP', 'Elevated Left Atrial Pressure', 'hierarchical composite, analyzed by the Finkelstein-Schoenfeld methodology, that includes (1) cardiovascular mortality or first nonfatal ischemic stroke through 12 months; (2) total (first plus recurrent']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0428877', 'cui_str': 'Atrial pressure'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C4544192', 'cui_str': 'Interatrial shunt'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}]",608.0,0.173581,≥40% demonstrated reductions in pulmonary capillary wedge pressure (PCWP) with a novel transcatheter InterAtrial Shunt Device (IASD).,"[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Berry', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mauri', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Feldman', 'Affiliation': 'NorthShore University Health System, Evanston, IL.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Komtebedde', 'Affiliation': 'Corvia Medical, Tewksbury, MA.'}, {'ForeName': 'Dirk J', 'Initials': 'DJ', 'LastName': 'van Veldhuisen', 'Affiliation': 'University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA.""}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Massaro', 'Affiliation': 'Boston University, Boston, MA.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL. Electronic address: sanjiv.shah@northwestern.edu.'}]",American heart journal,['10.1016/j.ahj.2019.10.015']
1494,32654554,Carbidopa for Afferent Baroreflex Failure in Familial Dysautonomia: A Double-Blind Randomized Crossover Clinical Trial.,"Afferent lesions of the arterial baroreflex occur in familial dysautonomia. This leads to excessive blood pressure variability with falls and frequent surges that damage the organs. These hypertensive surges are the result of excess peripheral catecholamine release and have no adequate treatment. Carbidopa is a selective DOPA-decarboxylase inhibitor that suppresses catecholamines production outside the brain. To learn whether carbidopa can inhibit catecholamine-induced hypertensive surges in patients with severe afferent baroreflex failure, we conducted a double-blind randomized crossover trial in which patients with familial dysautonomia received high dose carbidopa (600 mg/day), low-dose carbidopa (300 mg/day), or matching placebo in 3 4-week treatment periods. Among the 22 patients enrolled (13 females/8 males), the median age was 26 (range, 12-59 years). At enrollment, patients had hypertensive peaks to 164/116 (range, 144/92 to 213/150 mm Hg). Twenty-four hour urinary norepinephrine excretion, a marker of peripheral catecholamine release, was significantly suppressed on both high dose and low dose carbidopa, compared with placebo ( P =0.0075). The 2 co-primary end points of the trial were met. The SD of systolic BP variability was reduced at both carbidopa doses (low dose: 17±4; high dose: 18±5 mm Hg) compared with placebo (23±7 mm Hg;  P =0.0013), and there was a significant reduction in the systolic BP peaks on active treatment ( P =0.0015). High- and low-dose carbidopa were similarly effective and well tolerated. This study provides class Ib evidence that carbidopa can reduce blood pressure variability in patients with congenital afferent baroreflex failure. Similar beneficial effects are observed in patients with acquired baroreflex lesions.",2020,"Twenty-four hour urinary norepinephrine excretion, a marker of peripheral catecholamine release, was significantly suppressed on both high dose and low dose carbidopa, compared with placebo ( P =0.0075).","['patients had hypertensive peaks to 164/116 (range, 144/92 to 213/150 mm Hg', 'patients with congenital afferent baroreflex failure', 'Familial Dysautonomia', 'familial dysautonomia', '22 patients enrolled (13 females/8 males), the median age was 26 (range, 12-59 years', 'patients with familial dysautonomia', 'patients with severe afferent baroreflex failure', 'patients with acquired baroreflex lesions']","['placebo', 'carbidopa', 'High- and low-dose carbidopa', 'Carbidopa']","['SD of systolic BP variability', 'effective and well tolerated', 'systolic BP peaks', 'blood pressure variability']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0013364', 'cui_str': 'Familial dysautonomia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",22.0,0.236703,"Twenty-four hour urinary norepinephrine excretion, a marker of peripheral catecholamine release, was significantly suppressed on both high dose and low dose carbidopa, compared with placebo ( P =0.0075).","[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Norcliffe-Kaufmann', 'Affiliation': 'From the Department of Neurology, NYU Dysautonomia Center, New York University School of Medicine.'}, {'ForeName': 'Jose-Alberto', 'Initials': 'JA', 'LastName': 'Palma', 'Affiliation': 'From the Department of Neurology, NYU Dysautonomia Center, New York University School of Medicine.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Martinez', 'Affiliation': 'From the Department of Neurology, NYU Dysautonomia Center, New York University School of Medicine.'}, {'ForeName': 'Horacio', 'Initials': 'H', 'LastName': 'Kaufmann', 'Affiliation': 'From the Department of Neurology, NYU Dysautonomia Center, New York University School of Medicine.'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.15267']
1495,32659313,"Long-term, open-label extension study of the efficacy and safety of epicutaneous immunotherapy for peanut allergy in children: PEOPLE 3-year results.","BACKGROUND


The PEPITES (Peanut EPIT Efficacy and Safety) trial, a 12-month randomized controlled study of children with peanut allergy and 4 to 11 years old, previously reported the safety and efficacy of epicutaneous immunotherapy (EPIT) for peanut allergy (250 μg, daily epicutaneous peanut protein; DBV712 250 μg).
OBJECTIVE


We sought to assess interim safety and efficacy of an additional 2 years of EPIT from the ongoing (5-year treatment) PEOPLE (PEPITES Open-Label Extension) study.
METHODS


Subjects who completed PEPITES were offered enrollment in PEOPLE. Following an additional 2 years of daily DBV712 250 μg, subjects who had received DBV712 250 μg in PEPITES underwent month-36 double-blind, placebo-controlled food challenge with an optional month-38 sustained unresponsiveness assessment.
RESULTS


Of 213 eligible subjects who had received DBV712 250 μg in PEPITES, 198 (93%) entered PEOPLE, of whom 141 (71%) had assessable double-blind, placebo-controlled food challenge at month 36. At month 36, 51.8% of subjects (73 of 141) reached an eliciting dose of ≥1000 mg, compared with 40.4% (57 of 141) at month 12; 75.9% (107 of 141) demonstrated increased eliciting dose compared with baseline; and 13.5% (19 of 141) tolerated the full double-blind, placebo-controlled food challenge of 5444 mg. Median cumulative reactive dose increased from 144 to 944 mg. Eighteen subjects underwent an optional sustained unresponsiveness assessment; 14 of those (77.8%) maintained an eliciting dose of ≥1000 mg at month 38. Local patch-site skin reactions were common but decreased over time. There was no treatment-related epinephrine use in years 2 or 3. Compliance was high (96.9%), and withdrawals due to treatment-related adverse events were low (1%).
CONCLUSIONS


These results demonstrate that daily EPIT treatment for peanut allergy beyond 1 year leads to continued response from a well-tolerated, simple-to-use regimen.",2020,"Compliance was high (96.9%), and withdrawals due to treatment-related adverse events low (1%).
","['peanut-allergic children aged 4-11 years', '198 (93%) of 213 eligible subjects who had received DBV712 250μg in PEPITES entered PEOPLE, of whom 141 (71%) had assessable DBPCFC at Month 36', '18 subjects underwent an', 'Subjects who completed PEPITES were offered enrollment in PEOPLE', 'Peanut Allergy in Children']","['Epicutaneous Immunotherapy', 'epicutaneous immunotherapy (EPIT™', 'optional SU', 'placebo-controlled, food challenge (DBPCFC) with an optional Month-38 sustained unresponsiveness (SU) assessment']","['Compliance', 'Median cumulative reactive dose', 'Local patch-site skin reactions', 'ED', 'interim safety and efficacy']","[{'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",213.0,0.147914,"Compliance was high (96.9%), and withdrawals due to treatment-related adverse events low (1%).
","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fleischer', 'Affiliation': ""Section of Allergy and Immunology, Department of Pediatrics, Children's Hospital Colorado, University of Colorado Denver School of Medicine, Aurora, Colo. Electronic address: david.fleischer@childrenscolorado.org.""}, {'ForeName': 'Wayne G', 'Initials': 'WG', 'LastName': 'Shreffler', 'Affiliation': 'Food Allergy Center, Departments of Pediatrics and Medicine, Massachusetts General Hospital, Boston, Mass.'}, {'ForeName': 'Dianne E', 'Initials': 'DE', 'LastName': 'Campbell', 'Affiliation': ""Department of Allergy and Immunology, The Children's Hospital at Westmead, Sydney, Australia; DBV Technologies, Montrouge, France.""}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Green', 'Affiliation': ""DBV Technologies, Montrouge, France; Division of Allergy and Immunology, Department of Pediatrics, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, Pa.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Anvari', 'Affiliation': ""Section of Immunology, Allergy and Rheumatology, Texas Children's Hospital, Houston, Tex; Department of Pediatrics, Allergy and Immunology Section, Baylor College of Medicine, Houston, Tex.""}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': ""Assa'ad"", 'Affiliation': ""Department of Pediatrics, Cincinnati Children's Hospital Medical Center, The University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bégin', 'Affiliation': 'Division of Clinical Immunology and Allergy, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Beyer', 'Affiliation': 'Department of Pediatric Pneumology, Immunology and Intensive Care Medicine, Charité Universitatsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Bird', 'Affiliation': 'Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Tex.'}, {'ForeName': 'Terri', 'Initials': 'T', 'LastName': 'Brown-Whitehorn', 'Affiliation': ""Division of Allergy and Immunology, The Children's Hospital of Philadelphia, Philadelphia, Pa; Department of Pediatrics, Perelman School of Medicine at University of Pennsylvania, Philadelphia, Pa.""}, {'ForeName': 'Aideen', 'Initials': 'A', 'LastName': 'Byrne', 'Affiliation': ""Paediatric Allergy Department, Our Lady's Children's Hospital, Dublin, Ireland.""}, {'ForeName': 'Edmond S', 'Initials': 'ES', 'LastName': 'Chan', 'Affiliation': ""Department of Pediatrics, British Columbia Children's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Amarjit', 'Initials': 'A', 'LastName': 'Cheema', 'Affiliation': 'Cheema Research Inc, Mississauga, Ontario, Canada.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Chinthrajah', 'Affiliation': 'Sean N. Parker Center for Allergy and Asthma Research, Stanford University, Palo Alto, Calif.'}, {'ForeName': 'Hey Jin', 'Initials': 'HJ', 'LastName': 'Chong', 'Affiliation': ""Division of Allergy and Immunology, Department of Pediatrics, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, Pa.""}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Davis', 'Affiliation': 'Department of Pediatrics, Allergy and Immunology Section, Baylor College of Medicine, Houston, Tex.'}, {'ForeName': 'Lara S', 'Initials': 'LS', 'LastName': 'Ford', 'Affiliation': ""Department of Allergy and Immunology, The Children's Hospital at Westmead, Sydney, Australia; Discipline of Child and Adolescent Health, University of Sydney, Sydney, Australia.""}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Gagnon', 'Affiliation': ""Service d'Allergie et Immunologie, Département de Médecine, Centre Hospitalier Universitaire de Québec, Quebec, Canada.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Greenhawt', 'Affiliation': ""Section of Allergy and Immunology, Department of Pediatrics, Children's Hospital Colorado, University of Colorado Denver School of Medicine, Aurora, Colo.""}, {'ForeName': ""Jonathan O'B"", 'Initials': 'JO', 'LastName': 'Hourihane', 'Affiliation': 'Paediatrics and Child Health, INFANT Centre and Health Research Board-Clinical Research Facility, University College Cork, Cork, Ireland; Department of Paediatrics, Royal College of Surgeons, Dublin, Ireland.'}, {'ForeName': 'Stacie M', 'Initials': 'SM', 'LastName': 'Jones', 'Affiliation': ""Pediatrics - Allergy and Immunology, University of Arkansas for Medical Sciences, Arkansas Children's Hospital, Little Rock, Ark.""}, {'ForeName': 'Edwin H', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Allergy and Immunology, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lange', 'Affiliation': 'Department of Pediatrics, St. Marien Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Lanser', 'Affiliation': 'Division of Pediatric Allergy and Clinical Immunology, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Leonard', 'Affiliation': ""Department of Pediatrics, University of California San Diego, San Diego, Calif; Rady Children's Hospital, San Diego, Calif.""}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Mahler', 'Affiliation': 'Department of Dermatology, University Hospital Erlangen, Friedrich-Alexander-University, Erlangen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Maronna', 'Affiliation': 'Department of Dermatology, University Hospital Erlangen, Friedrich-Alexander-University, Erlangen, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nowak-Wegrzyn', 'Affiliation': ""Hassenfeld Children's Hospital at New York University Langone Health, New York, NY; Department of Pediatrics, Gastroenterology and Nutrition, Collegium Medicum, University of Warmia and Mazury, Olsztyn, Poland.""}, {'ForeName': 'Roxanne C', 'Initials': 'RC', 'LastName': 'Oriel', 'Affiliation': 'Division of Pediatric Allergy and Immunology, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Sullivan"", 'Affiliation': ""Perth Children's Hospital, Nedlands, Australia.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Petroni', 'Affiliation': 'Seattle Allergy and Asthma Research Institute, Seattle, Wash.'}, {'ForeName': 'Jacqueline A', 'Initials': 'JA', 'LastName': 'Pongracic', 'Affiliation': ""Allergy and Immunology Division, Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Ill.""}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': ""Perth Children's Hospital, Nedlands, Australia; Department of Paediatrics, The University of Western Australia School of Medicine, Perth, Australia.""}, {'ForeName': 'Lynda C', 'Initials': 'LC', 'LastName': 'Schneider', 'Affiliation': ""Division of Immunology, Boston Children's Hospital, Boston, Mass.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Smith', 'Affiliation': 'School of Medical Science, Griffith University, Southport, Australia.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Staab', 'Affiliation': 'Department of Pediatrics, Division of Pulmonology, Immunology and Critical Care Medicine, Charité-Universitaetsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Sussman', 'Affiliation': 'Gordon Sussman Clinical Research, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wood', 'Affiliation': 'Division of Allergy and Clinical Immunology, Johns Hopkins Hospital, Baltimore, Md.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Yang', 'Affiliation': 'Department of Medicine, University of Ottawa Medical School, Ottawa, Ontario, Canada.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Lambert', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Peillon', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Timothée', 'Initials': 'T', 'LastName': 'Bois', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': 'DBV Technologies, Montrouge, France; Division of Pediatric Allergy and Immunology, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.06.028']
1496,32659437,Testing the effectiveness of physical activity advice delivered via text messaging vs. human phone advisors in a Latino population: The On The Move randomized controlled trial design and methods.,"Physical inactivity is a key risk factor for a range of chronic diseases and conditions, yet, approximately 50% of U.S. adults fall below recommended levels of regular aerobic physical activity (PA). This is particularly true for ethnic minority populations such as Latino adults for whom few culturally adapted programs have been developed and tested. Text messaging (SMS) represents a convenient and accessible communication channel for delivering targeted PA information and support, but has not been rigorously evaluated against standard telehealth advising programs. The objective of the On The Move randomized controlled trial is to test the effectiveness of a linguistically and culturally targeted SMS PA intervention (SMS PA Advisor) versus two comparison conditions: a) a standard, staff-delivered phone PA intervention (Telephone PA Advisor) and b) an attention-control arm consisting of a culturally targeted SMS intervention to promote a healthy diet (SMS Nutrition Advisor). The study sample (N = 350) consists of generally healthy, insufficiently active Latino adults ages 35 years and older living in five northern California counties. Study assessments occur at baseline, 6, and 12 months, with a subset of participants completing 18-month assessments. The primary outcome is 12-month change in walking, and secondary outcomes include other forms of PA, assessed via validated self-report measures and supported by accelerometry, and physical function and well-being variables. Potential mediators and moderators of intervention success will be explored to better determine which subgroups do best with which type of intervention. Here we present the study design and methods, including recruitment strategies and yields. Trial Registration: clinicaltrial.gov Identifier = NCT02385591.",2020,Potential mediators and moderators of intervention success will be explored to better determine which subgroups do best with which type of intervention.,"['Latino population', 'The study sample (N\u202f=\u202f350) consists of generally healthy, insufficiently active Latino adults ages 35\u202fyears and older living in five northern California counties']","['phone PA intervention (Telephone PA Advisor) and b) an attention-control arm consisting of a culturally targeted SMS intervention', 'linguistically and culturally targeted SMS PA intervention (SMS PA Advisor', 'Text messaging (SMS', 'physical activity advice delivered via text messaging vs. human phone advisors']","['12-month change in walking, and secondary outcomes include other forms of PA, assessed via validated self-report measures and supported by accelerometry, and physical function and well-being variables']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.0964757,Potential mediators and moderators of intervention success will be explored to better determine which subgroups do best with which type of intervention.,"[{'ForeName': 'Abby C', 'Initials': 'AC', 'LastName': 'King', 'Affiliation': 'Department of Epidemiology & Population Health, Stanford University School of Medicine, Stanford, CA 94305, United States of America; Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: king@stanford.edu.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Campero', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: icampero@stanford.edu.'}, {'ForeName': 'Jylana L', 'Initials': 'JL', 'LastName': 'Sheats', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: JSheats@tulane.edu.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Castro Sweet', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: cynthia@omadahealth.com.'}, {'ForeName': 'Patricia Rodriguez', 'Initials': 'PR', 'LastName': 'Espinosa', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: prespinosa@stanford.edu.'}, {'ForeName': 'Dulce', 'Initials': 'D', 'LastName': 'Garcia', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: dgarcia3@stanford.edu.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hauser', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: mehauser@stanford.edu.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Done', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: mdone@stanford.edu.'}, {'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Patel', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: michele.patel@stanford.edu.'}, {'ForeName': 'Nina M', 'Initials': 'NM', 'LastName': 'Parikh', 'Affiliation': 'CareMessage, Inc., San Francisco, California 94115, United States of America. Electronic address: nparikh@caremessage.org.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Corral', 'Affiliation': 'CareMessage, Inc., San Francisco, California 94115, United States of America. Electronic address: ccorral@caremessage.org.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Ahn', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Stanford, CA 94305, United States of America. Electronic address: dahn@stanford.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106084']
1497,32659480,Effectiveness of a physiologic voice therapy program based on different semioccluded vocal tract exercises in subjects with behavioral dysphonia: A randomized controlled trial.,"PURPOSE


The present study aimed to assess the effectiveness of a physiologic voice therapy program based on different semioccluded vocal tract exercises in subjects with behavioral dysphonia.
METHODS


Thirty-four participants with behavioral dysphonia were randomly assigned to one of two treatment groups: 1) voice treatment with physiologic voice therapy plus vocal hygiene program (n=20), and 2) vocal hygiene program only (n=14). Laryngoscopic assessment was performed in all subjects. Before and after voice therapy, participants underwent aerodynamic, electroglottographic, and acoustic assessment. The Voice Handicap Index (VHI), Voice symptom scale (VoiSs), Vocal tract discomfort scale (VTDS), and self-assessment of resonant voice quality were also performed. The treatment included eight voice therapy sessions. For the experimental group, the exercises consisted of a sequence of seven phonatory tasks performed with four different semioccluded vocal tract exercises (SOVTE). Comparison for all variables were performed between experimental group and control group.
RESULTS


Wilcoxon test showed significant improvements for experimental group for VHI, VoiSs, VTDS (decrease), and self-perception of resonant voice quality (increase). Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
CONCLUSION


Physiologic voice therapy based on semioccluded vocal tract exercises seems to be an effective tool to improve voice in subjects diagnosed with behavioral dysphonia. Apparently, most changes should be expected in variables related to physical and functional aspects compared to objective variables. Subglottic pressure and phonation threshold pressure seem to be the most change-sensitive parameters and they may reflect a reduction in phonatory effort reported by patients after voice therapy.",2020,"Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
","['subjects diagnosed with behavioral dysphonia', 'Thirty-four participants with behavioral dysphonia', 'subjects with behavioral dysphonia']","['physiologic voice therapy program', 'phonatory tasks performed with four different semioccluded vocal tract exercises (SOVTE', 'voice treatment with physiologic voice therapy plus vocal hygiene program (n=20), and 2) vocal hygiene program', 'Physiologic voice therapy']","['VHI, VoiSs, VTDS (decrease), and self-perception of resonant voice quality (increase', 'Subglottic pressure and phonation threshold pressure', 'Laryngoscopic assessment', 'Voice Handicap Index (VHI), Voice symptom scale (VoiSs), Vocal tract discomfort scale (VTDS), and self-assessment of resonant voice quality', 'subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}]","[{'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0577554', 'cui_str': 'Resonant'}, {'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0234833', 'cui_str': 'Subglottic pressure'}, {'cui': 'C0031577', 'cui_str': 'Laryngeal voice function'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]",34.0,0.0112718,"Significant decrease for experimental groups was observed on subglottic pressure, phonation threshold pressure, and glottal airflow across the implemented tasks.
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Guzman', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad de los Andes, Chile; Department of Otolaryngology, Las Condes Clinic, Santiago, Chile. Electronic address: guzmann.marcoa@gmail.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Bertucci', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: terebertucci@gmail.com.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Pacheco', 'Affiliation': 'Department of Otolaryngology, Las Condes Clinic, Av. Estoril 850, Santiago, Chile. Electronic address: cpachecob@clinicalascondes.cl.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Leiva', 'Affiliation': 'Department of Communication Sciences and Disorders, Universidad Pedro de Valdivia, Vicuña Mackena 44, Santiago, Chile. Electronic address: fernando.leiva.solari@gmail.com.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Quintana', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: quintana.b.felipe@gmail.com.'}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Ansaldi', 'Affiliation': 'Facultad de Ciencias de la Salud, Universidad de las Américas, Santiago, Chile. Electronic address: romina.ansaldi@gmail.com.'}, {'ForeName': 'Camilo', 'Initials': 'C', 'LastName': 'Quezada', 'Affiliation': 'Department of Communication Sciences and Disorders, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: cequezad@uc.cl.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Department of Otolaryngology, University of Chile, Av. Independencia 1027, Santiago, Chile. Electronic address: daniel.uchile@gmail.com.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106023']
1498,32660657,Daily mycoprotein consumption for 1 week does not affect insulin sensitivity or glycaemic control but modulates the plasma lipidome in healthy adults: a randomised controlled trial.,"Mycoprotein consumption has been shown to improve acute postprandial glycaemic control and decrease circulating cholesterol concentrations. We investigated the impact of incorporating mycoprotein into the diet on insulin sensitivity (IS), glycaemic control and plasma lipoprotein composition. Twenty healthy adults participated in a randomised, parallel-group trial in which they consumed a 7 d fully controlled diet where lunch and dinner contained either meat/fish (control group, CON) or mycoprotein (MYC) as the primary source of dietary protein. Oral glucose tolerance tests were performed pre- and post-intervention, and 24 h continuous blood glucose monitoring was applied throughout. Fasting plasma samples were obtained pre- and post-intervention and were analysed using quantitative, targeted NMR-based metabonomics. There were no changes within or between groups in blood glucose or serum insulin responses, nor in IS or 24 h glycaemic profiles. No differences between groups were found for 171 of the 224 metabonomic targets. Forty-five lipid concentrations of different lipoprotein fractions (VLDL, LDL, intermediate-density lipoprotein and HDL) remained unchanged in CON but showed a coordinated decrease (7-27 %; all P < 0·05) in MYC. Total plasma cholesterol, free cholesterol, LDL-cholesterol, HDL2-cholesterol, DHA and n-3 fatty acids decreased to a larger degree in MYC (14-19 %) compared with CON (3-11 %; P < 0·05). Substituting meat/fish for mycoprotein twice daily for 1 week did not modulate whole-body IS or glycaemic control but resulted in changes to plasma lipid composition, the latter primarily consisting of a coordinated reduction in circulating cholesterol-containing lipoproteins.",2020,"There were no changes within or between groups in blood glucose or serum insulin responses, nor in IS (Cederholm; 51±3 to 51±3 and 54±3 to 53±3 mg.","['healthy adults', 'Twenty healthy adults']","['Mycoprotein consumption', '7 d fully-controlled diet where lunch and dinner contained either meat/fish (CON) or mycoprotein (MYC']","['Fasting plasma samples', 'lipoprotein fractions (VLDL, LDL, IDL and HDL', 'Total plasma cholesterol, free-C, LDL-C, HDL2-C, DHA and omega-3 fatty acids', 'blood glucose or serum insulin responses', 'acute postprandial glycaemic control and decrease circulating cholesterol concentrations', 'Oral glucose tolerance tests', 'insulin sensitivity or glycaemic control', 'insulin sensitivity (IS), glycaemic control and plasma lipoprotein composition']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C2347312', 'cui_str': 'Mycoprotein'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0523559', 'cui_str': 'IDL cholesterol measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0858034', 'cui_str': 'Plasma cholesterol'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1847987', 'cui_str': 'Huntington disease-like 2'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0583325', 'cui_str': 'Plasma lipoprotein measurement'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",20.0,0.0269796,"There were no changes within or between groups in blood glucose or serum insulin responses, nor in IS (Cederholm; 51±3 to 51±3 and 54±3 to 53±3 mg.","[{'ForeName': 'Mariana O C', 'Initials': 'MOC', 'LastName': 'Coelho', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter,ExeterEX1 2LU, UK.'}, {'ForeName': 'Alistair J', 'Initials': 'AJ', 'LastName': 'Monteyne', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter,ExeterEX1 2LU, UK.'}, {'ForeName': 'Marlou L', 'Initials': 'ML', 'LastName': 'Dirks', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter,ExeterEX1 2LU, UK.'}, {'ForeName': 'Tim J A', 'Initials': 'TJA', 'LastName': 'Finnigan', 'Affiliation': 'Marlow Foods Ltd., StokesleyTS9 7AB, UK.'}, {'ForeName': 'Francis B', 'Initials': 'FB', 'LastName': 'Stephens', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter,ExeterEX1 2LU, UK.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Wall', 'Affiliation': 'Department of Sport and Health Sciences, College of Life and Environmental Sciences, University of Exeter,ExeterEX1 2LU, UK.'}]",The British journal of nutrition,['10.1017/S0007114520002524']
1499,32660675,Combined anthocyanins and bromelain supplement improves endothelial function and skeletal muscle oxygenation status in adults: a double-blind placebo-controlled randomised crossover clinical trial.,"Anthocyanins and bromelain have gained significant attention due to their antioxidative and anti-inflammatory properties. Both have been shown to improve endothelial function, blood pressure (BP) and oxygen utility capacity in humans; however, the combination of these two and the impacts on endothelial function, BP, total antioxidant capacity (TAC) and oxygen utility capacity have not been previously investigated. The purpose of this study was to investigate the impacts of a combined anthocyanins and bromelain supplement (BE) on endothelial function, BP, TAC, oxygen utility capacity and fatigability in healthy adults. Healthy adults (n 18, age 24 (sd 4) years) received BE or placebo in a randomised crossover design. Brachial artery flow-mediated dilation (FMD), BP, TAC, resting heart rate, oxygen utility capacity and fatigability were measured pre- and post-BE and placebo intake. The BE group showed significantly increased FMD, reduced systolic BP and improved oxygen utility capacity compared with the placebo group (P < 0·05). Tissue saturation and oxygenated Hb significantly increased following BE intake, while deoxygenated Hb significantly decreased (P < 0·05) during exercise. Additionally, TAC was significantly increased following BE intake (P < 0·05). There were no significant differences for resting heart rate, diastolic BP or fatigability index. These results suggest that BE intake is an effective nutritional therapy for improving endothelial function, BP, TAC and oxygen utility capacity, which may be beneficial to support vascular health in humans.",2020,Tissue saturation and oxygenated hemoglobin significantly increased following BE intake while deoxygenated hemoglobin significantly decreased (p<0.05) during exercise.,"['adults', 'healthy adults', 'Healthy adults (n=18, age 24±4) received']","['Anthocyanins and bromelain', 'BE or placebo', 'combined anthocyanins and bromelain supplement (BE', 'TAC', 'Combined anthocyanins and bromelain supplement', 'placebo']","['endothelial function, BP, TAC, oxygen utility capacity, and fatigability', 'resting heart rate, diastolic BP, or fatigability index', 'endothelial function, BP TAC, and oxygen utility capacity', 'deoxygenated hemoglobin', 'FMD, reduced systolic BP, and improved oxygen utility capacity', 'Brachial artery flow-mediated dilation (FMD), BP, TAC, resting heart rate, oxygen utility capacity, and fatigability', 'endothelial function, BP, total antioxidant capacity (TAC), and oxygen utility capacity', 'Tissue saturation and oxygenated hemoglobin', 'endothelial function, blood pressure (BP), and oxygen utility capacity', 'endothelial function and skeletal muscle oxygenation status']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0006217', 'cui_str': 'Bromelains'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0277885', 'cui_str': 'Decreased systolic arterial pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.183709,Tissue saturation and oxygenated hemoglobin significantly increased following BE intake while deoxygenated hemoglobin significantly decreased (p<0.05) during exercise.,"[{'ForeName': 'Elizabeth J', 'Initials': 'EJ', 'LastName': 'Pekas', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE 68182, USA.'}, {'ForeName': 'Jeonghwa', 'Initials': 'J', 'LastName': 'Shin', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE 68182, USA.'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Headid', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE 68182, USA.'}, {'ForeName': 'Won-Mok', 'Initials': 'WM', 'LastName': 'Son', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE 68182, USA.'}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Layec', 'Affiliation': 'Department of Kinesiology, University of Massachusetts Amherst, Amherst, MA01003, USA.'}, {'ForeName': 'Santosh K', 'Initials': 'SK', 'LastName': 'Yadav', 'Affiliation': 'Department of Cellular & Integrative Physiology, University of Nebraska Medical Center, Omaha, NE68198, USA.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Scott', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE 68182, USA.'}, {'ForeName': 'Song-Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'School of Health and Kinesiology, University of Nebraska Omaha, Omaha, NE 68182, USA.'}]",The British journal of nutrition,['10.1017/S0007114520002548']
1500,32662699,Can Brief Email Guidance Enhance the Effects of an Internet Intervention for People with Problematic Alcohol Use? A Randomized Controlled Trial.,"BACKGROUND


Some research suggests that internet interventions aimed at people with problematic alcohol use are more effective when provided with guidance from a therapist or coach.  Purpose/Objectives:  This trial intended to compare the effects of a previously evaluated internet intervention for people with problematic alcohol use when delivered with or without brief email guidance.  Methods:  Using online advertising, 238 participants, 18 years or older, were recruited and randomized to receive access to the Internet intervention Alcohol Help Center with or without brief email guidance from a health educator. The guidance consisted of at least four structured, slightly individualized emails delivered during the first two weeks after randomization. Participants were followed up at 3 and 6 months.  Results:  Number of log-ins did not differ significantly between groups throughout the follow-up period. The follow-up rate at 6 months was 47.0%. Generalized estimating equations run on the primary (standard drinks in preceding week/heavy drinking days in preceding week) and secondary outcome variables (AUDIT, AUDIT-C, quality of life) revealed no significant differences between the interventions on any of the outcomes.  Conclusions/Importance:  The study does not provide support for any added benefits of providing brief guidance  via  email in an internet intervention for problem drinkers.",2020,The study does not provide support for any added benefits of providing brief guidance  via  email in an internet intervention for problem drinkers.,"['people with problematic alcohol', 'People with Problematic Alcohol Use', 'problem drinkers', '238 participants, 18\u2009years or older']","['Internet Intervention', 'internet intervention', 'Internet intervention Alcohol Help Center with or without brief email guidance from a health educator']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C1136362', 'cui_str': 'Health educator'}]",[],238.0,0.0894453,The study does not provide support for any added benefits of providing brief guidance  via  email in an internet intervention for problem drinkers.,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sundström', 'Affiliation': 'Department of Clinical Neuroscience, Centre for Psychiatric Research, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schell', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Wardell', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Godinho', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Cunningham', 'Affiliation': 'Centre for Addiction and Mental Health, Institute for Mental Health Policy Research, Toronto, Canada.'}]",Substance use & misuse,['10.1080/10826084.2020.1788087']
1501,32623839,"Effects of ipragliflozin versus metformin in combination with sitagliptin on bone and muscle in Japanese patients with type 2 diabetes mellitus: Subanalysis of a prospective, randomized, controlled study (PRIME-V study).","AIMS/INTRODUCTION


Recent randomized clinical trials have suggested that sodium-glucose cotransporter 2 inhibitors might reduce cardiovascular events and heart failure, and have renal protective effects. Despite these remarkable benefits, the effects of sodium-glucose cotransporter 2 inhibitors on bone and muscle are unclear.
MATERIALS AND METHODS


A subanalysis of a randomized controlled study was carried out to evaluate the effects of the sodium-glucose cotransporter 2 inhibitor, ipragliflozin, versus metformin on bone and muscle in Japanese patients with type 2 diabetes mellitus (baseline body mass index ≥22 kg/m 2  and hemoglobin A1c 7-10%) who were already receiving sitagliptin. These patients were randomly administered ipragliflozin 50 mg or metformin 1,000-1,500 mg daily. The effects of these medications on the bone formation marker, bone alkali phosphatase; the bone resorption marker, tartrate-resistant acid phosphatase 5b (TRACP-5b); handgrip strength; abdominal cross-sectional muscle area; and bone density of the fourth lumbar vertebra were evaluated.
RESULTS


After 24 weeks of treatment, the changes in bone density of the fourth lumbar vertebra, handgrip strength and abdominal cross-sectional muscle area were not significantly different between the two groups. However, TRACP-5b levels increased in patients treated with ipragliflozin compared with patients treated with metformin (median 11.94 vs -10.30%, P < 0.0001), showing that ipragliflozin can promote bone resorption.
CONCLUSIONS


There were no adverse effects on bone or muscle when sitagliptin was used in combination with either ipragliflozin or metformin. However, ipragliflozin combination increased the levels of TRACP-5b. A long-term study is required to further understand the effects of this TRACP-5b increase caused by ipragliflozin.",2020,There were no adverse effects on bone or muscle when sitagliptin was used in combination with either ipragliflozin or metformin.,"['Japanese patients with type 2 diabetes mellitus', 'Japanese patients with type 2 diabetes mellitus (baseline BMI ≥ 22 kg/m 2  and HbA1c 7-10 %) who were already receiving sitagliptin']","['SGLT2 inhibitors', 'SGLT2 inhibitor, ipragliflozin, versus metformin', 'sodium-glucose co-transporter-2 (SGLT2) inhibitors', 'metformin', 'ipragliflozin versus metformin', 'sitagliptin', 'ipragliflozin or metformin', 'ipragliflozin', 'ipragliflozin 50 mg or metformin', 'TRACP-5b']","['TRACP-5b levels', 'cardiovascular events and heart failure', 'levels of TRACP-5b', 'bone resorption', 'bone density of the fourth lumbar vertebra, handgrip strength, and abdominal cross-sectional muscle area', 'bone formation marker, bone alkali phosphatase (BAP); the bone resorption marker, tartrate-resistant acid phosphatase 5b (TRACP-5b); handgrip strength; abdominal cross-sectional muscle area; and bone density of the fourth lumbar vertebra']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}]","[{'cui': 'C0297331', 'cui_str': 'Acid phosphatase bone isoenzyme'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0223537', 'cui_str': 'Bone structure of L4'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031678', 'cui_str': 'Phosphoric monoester hydrolase'}]",,0.0658579,There were no adverse effects on bone or muscle when sitagliptin was used in combination with either ipragliflozin or metformin.,"[{'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Koshizaka', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Ko', 'Initials': 'K', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Ishibashi', 'Affiliation': 'Department of Endocrinology, Hematology, and Gerontology, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Maezawa', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Endocrinology, Hematology, and Gerontology, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Daigaku', 'Initials': 'D', 'LastName': 'Uchida', 'Affiliation': 'Hotaruno Central Naika, Kisarazu, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Nakamura', 'Affiliation': 'Odayama Clinic, Kisarazu, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Yamaga', 'Affiliation': 'Department of Diabetes and Metabolism, Japanese Red Cross Narita Hospital, Narita, Japan.'}, {'ForeName': 'Hidetaka', 'Initials': 'H', 'LastName': 'Yokoh', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Akina', 'Initials': 'A', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Shunichiro', 'Initials': 'S', 'LastName': 'Onishi', 'Affiliation': 'Department of Diabetes and Metabolism, Asahi General Hospital, Asahi, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Endocrinology, Hematology, and Gerontology, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ogino', 'Affiliation': ""Department of Diabetes, Endocrine and Metabolic Disease, Tokyo Women's Medical University Yachiyo Medical Center, Yachiyo, Japan.""}, {'ForeName': 'Naotake', 'Initials': 'N', 'LastName': 'Hashimoto', 'Affiliation': ""Department of Diabetes, Endocrine and Metabolic Disease, Tokyo Women's Medical University Yachiyo Medical Center, Yachiyo, Japan.""}, {'ForeName': 'Hirotake', 'Initials': 'H', 'LastName': 'Tokuyama', 'Affiliation': 'Yukarigaoka Tokuyama Medical Clinic, Sakura, Japan.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Shimada', 'Affiliation': 'Department of Diabetes and Metabolism, National Hospital Organization Chiba Medical Center, Chiba, Japan.'}, {'ForeName': 'Emi', 'Initials': 'E', 'LastName': 'Ohara', 'Affiliation': 'Department of Diabetes and Metabolism, National Hospital Organization Chiba Medical Center, Chiba, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Mayumi', 'Initials': 'M', 'LastName': 'Shoji', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Ide', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Ide', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Baba', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Hattori', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Kitamoto', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Takuro', 'Initials': 'T', 'LastName': 'Horikoshi', 'Affiliation': 'Diagnostic Radiology and Radiation Oncology, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Ryouta', 'Initials': 'R', 'LastName': 'Shimofusa', 'Affiliation': 'Department of Radiology, Sannou Hospital, Chiba, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Clinical Research Support Center, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Nagashima', 'Affiliation': 'Research Center for Medical and Health Data Science, The Institute of Statistical Mathematics, Tachikawa, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Preventive Medicine and Public Health, Keio University School of Medicine, Shinjuku-ku, Japan.'}, {'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Takemoto', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, International University of Health and Welfare, Narita, Japan.'}, {'ForeName': 'L Kristin', 'Initials': 'LK', 'LastName': 'Newby', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Koutaro', 'Initials': 'K', 'LastName': 'Yokote', 'Affiliation': 'Department of Medicine, Division of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of diabetes investigation,['10.1111/jdi.13340']
1502,32633901,Time course of pupillary response to threat words before and after attention bias modification for transdiagnostic anxiety disorders: A randomized controlled trial.,"INTRODUCTION


Altered attention to threatening stimuli at initial and sustained stages of processing may be dissociable dimensions that influence the development and maintenance of transdiagnostic symptoms of anxiety, such as vigilance, and possibly require distinct intervention. Attention bias modification (ABM) interventions were created to implicitly train attention away from threatening stimuli and have shown efficacy in treating anxiety. ABM alters neurocognitive functioning during initial stages of threat processing, but less is known regarding effects of ABM on neural indices of threat processing at sustained (i.e., intermediate and late) stages, or if ABM-related neural changes relate to symptom response. The current study utilized pupillary response as a temporally sensitive and cost-effective peripheral marker of neurocognitive response to ABM.
MATERIALS AND METHODS


In a randomized controlled trial, 79 patients with transdiagnostic anxiety provided baseline data, 70 were randomized to receive eight sessions of twice-weekly ABM (n = 49) or sham training (n = 21), and 65 completed their assigned treatment condition and returned for post-training assessment.
RESULTS


Among ABM, but not sham, patients, pupillary response to threat words during initial and intermediate stages decreased from pre- to post-training. Pre- to post-training reductions in intermediate and late pupillary response to threat were positively correlated with reductions in patient-reported vigilance among ABM, but not sham, patients.
CONCLUSIONS


All measured stages of threat processing had relevance in understanding the neural mechanisms of ABM, with overlapping yet dissociable roles exhibited within a single neurophysiological marker across an initial-intermediate-late time continuum. Pupillometry may be well suited to measure both target engagement and treatment outcome following ABM.",2020,"Pre- to post-training reductions in intermediate and late pupillary response to threat were positively correlated with reductions in patient-reported vigilance among ABM, but not sham, patients.
","['79 patients with transdiagnostic anxiety provided baseline data, 70', 'transdiagnostic anxiety disorders']","['ABM', 'twice-weekly ABM (n\xa0=\xa049) or sham training']",['pupillary response to threat words during initial and intermediate stages'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",79.0,0.0719312,"Pre- to post-training reductions in intermediate and late pupillary response to threat were positively correlated with reductions in patient-reported vigilance among ABM, but not sham, patients.
","[{'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Woody', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Vaughn-Coaxum', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Greg J', 'Initials': 'GJ', 'LastName': 'Siegle', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Price', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Brain and behavior,['10.1002/brb3.1664']
1503,32633899,Corticomotor reorganization during short-term visuomotor training in the lower back: A randomized controlled study.,"INTRODUCTION


Accumulating evidence suggests that motor skill training is associated with structural and functional reorganization of the primary motor cortex. However, previous studies have focussed primarily upon the upper limb, and it is unclear whether comparable reorganization occurs following training of other regions, such as the lower back. Although this holds important implications for rehabilitation, no studies have examined corticomotor adaptations following short-term motor training in the lower back.
METHOD


The aims of this study were to (a) determine whether a short-term lumbopelvic tilt visuomotor task induced reorganization of the corticomotor representations of lower back muscles, (b) quantify the variability of corticomotor responses to motor training, and (c) determine whether any improvements in task performance were correlated with corticomotor reorganization. Participants were allocated randomly to perform a lumbopelvic tilt motor training task (n = 15) or a finger abduction control task involving no lumbopelvic movement (n = 15). Transcranial magnetic stimulation was used to map corticomotor representations of the lumbar erector spinae before, during, and after repeated performance of the allocated task.
RESULTS


No relationship between corticomotor reorganization and improved task performance was identified. Substantial variability was observed in terms of corticomotor responses to motor training, with approximately 50% of participants showing no corticomotor reorganization despite significant improvements in task performance.
CONCLUSION


These findings suggest that short-term improvements in lower back visuomotor task performance may be driven by changes in remote subcortical and/or spinal networks rather than adaptations in corticomotor pathways. However, further research using tasks of varying complexities and durations is required to confirm this hypothesis.",2020,No relationship between corticomotor reorganization and improved task performance was identified.,[],"['motor skill training', 'Corticomotor reorganization during short-term visuomotor training', 'Transcranial magnetic stimulation', 'lumbopelvic tilt motor training task (n\xa0=\xa015) or a finger abduction control task involving no lumbopelvic movement']","['task performance', 'lower back visuomotor task performance']",[],"[{'cui': 'C0026612', 'cui_str': 'Motor Skills'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]","[{'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.0295293,No relationship between corticomotor reorganization and improved task performance was identified.,"[{'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Cavaleri', 'Affiliation': 'School of Health Sciences, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Lucy S', 'Initials': 'LS', 'LastName': 'Chipchase', 'Affiliation': 'School of Health Sciences, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Massé-Alarie', 'Affiliation': 'CIRRIS Research Centre, Department of Rehabilitation, Laval University, Quebec, Canada.'}, {'ForeName': 'Siobhan M', 'Initials': 'SM', 'LastName': 'Schabrun', 'Affiliation': 'Neuroscience Research Australia, Randwick, New South Wales, Australia.'}, {'ForeName': 'Muath A', 'Initials': 'MA', 'LastName': 'Shraim', 'Affiliation': 'Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Hodges', 'Affiliation': 'Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Queensland, Australia.'}]",Brain and behavior,['10.1002/brb3.1702']
1504,32629403,Monomethyl fumarate has better gastrointestinal tolerability profile compared with dimethyl fumarate.,"BACKGROUND


Monomethyl fumarate (MMF) is the pharmacologically active metabolite of dimethyl fumarate (DMF). MMF formulated as Bafiertam™ 190 mg and DMF formulated as Tecfidera 240 mg deliver bioequivalent exposure of MMF and therefore possess the same efficacy/safety profiles. DMF is a widely used oral treatment for relapsing-remitting forms of multiple sclerosis (RRMS) but is limited in some patients, primarily female, by issues with gastrointestinal (GI) tolerability.
METHODS


This was a randomized, double-blind, head-to-head, 5-week study evaluating the GI tolerability of MMF 190 mg vs DMF 240 mg, administered twice daily in healthy subjects, using a derivative of the self-administered Modified Overall Gastrointestinal Symptom Scale (MOGISS). Subjects were stratified (3:1, female:male) and randomized (1:1) to the treatments. The primary endpoint was the Area Under the Curve (AUC) in each of the individual symptoms in the MOGISS over the 5-week treatment period. Other endpoints included the AUC over the 5-week treatment period in the MOGISS composite and total scores; duration and severity of GI events; Number and percentage of subjects reporting GI events during the overall treatment period, and assessment of safety/tolerability.
RESULTS


Inferential analysis of the hierarchical testing of overall treatment differences in each MOGISS symptom AUC occurred in a predefined sequence starting with Abdominal Pain. For each symptom, LSMean AUC values were lower for MMF than DMF, however, the first primary endpoint, Abdominal Pain, was not statistically different between treatments; thus, all subsequent statistical analyses were considered exploratory. The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
CONCLUSIONS


Bafiertam showed an improved gastrointestinal tolerability profile compared with Tecfidera, with less severe GI events and fewer days of self-assessed GI symptoms, fewer GI adverse events, and lower discontinuation rates because of GI adverse events.",2020,"The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
",['healthy subjects'],"['DMF', 'Monomethyl fumarate (MMF', 'MMF 190 mg vs DMF']","['LSMean AUC values', 'MOGISS composite and total scores; duration and severity of GI events; Number and percentage of subjects reporting GI events', 'gastrointestinal tolerability profile', 'derivative of the self-administered Modified Overall Gastrointestinal Symptom Scale (MOGISS', 'Area Under the Curve (AUC', 'safety/tolerability', 'Abdominal Pain', 'GI tolerability', 'severe GI events and fewer days of self-assessed GI symptoms, fewer GI adverse events']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0058218', 'cui_str': 'dimethyl fumarate'}, {'cui': 'C3848524', 'cui_str': 'monomethyl fumarate'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C4517622', 'cui_str': '190'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0243072', 'cui_str': 'derivatives'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0797155,"The side effects and safety profiles observed were consistent with the known profiles of DMF, with no new or unique safety concerns noted.
","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wynn', 'Affiliation': 'Consultants in Neurology, Ltd, Northbrook, IL 60062, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Lategan', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA. Electronic address: Lategan@bannerls.com.'}, {'ForeName': 'Tiffany N', 'Initials': 'TN', 'LastName': 'Sprague', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA.'}, {'ForeName': 'Franck S', 'Initials': 'FS', 'LastName': 'Rousseau', 'Affiliation': 'Banner Life Sciences, 3890 Premier Dr., Suite 110, High Point, NC 27265, USA.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Fox', 'Affiliation': 'Central Texas Neurology Consultants, Round Rock, TX 78681, USA.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102335']
1505,32629949,Lifestyle Changes Observed among Adults Participating in a Family- and Community-Based Intervention for Diabetes Prevention in Europe: The 1 st  Year Results of the Feel4Diabetes-Study.,"The Feel4Diabetes intervention was a school and community-based intervention aiming to promote healthy lifestyle and tackle obesity and obesity-related metabolic risk factors for the prevention of type 2 diabetes (T2D) among families at risk of developing this disease. The current study aims to present the results on lifestyle behaviors obtained from parents during the first year of the Feel4Diabetes intervention. This multicomponent intervention had a cluster randomized design and was implemented in Belgium, Bulgaria, Finland, Greece, Hungary and Spain over two years (2016-2018). Standardized protocols and procedures were used by the participating centers in all countries to collect data on parents' lifestyle behaviors (diet, physical activity, sedentary behavior). The Feel4Diabetes intervention was registered at clinicaltrials.gov (registration number: NCT02393872). In total, 2110 high-risk parents participated in the baseline and 12-month follow-up examination measurements. Participants allocated to the intervention group reduced their daily consumption of sugary drinks ( p =  0.037) and sweets ( p =  0.031) and their daily screen time ( p =  0.032), compared with the control group. In addition, participants in the intervention group in Greece and Spain increased their consumption of breakfast ( p =  0.034) and fruits ( p  = 0.029), while in Belgium and Finland they increased their water intake ( p =  0.024). These findings indicate that the first year of the Feel4Diabetes intervention resulted in the improvement of certain lifestyle behaviors in parents from high-risk families.",2020,"Participants allocated to the intervention group reduced their daily consumption of sugary drinks ( p =  0.037) and sweets ( p =  0.031) and their daily screen time ( p =  0.032), compared with the control group.","['Adults Participating in a Family- and Community-Based Intervention for Diabetes Prevention in Europe', '2110 high-risk parents']",['school and community-based intervention aiming to promote healthy lifestyle and tackle obesity and obesity-related metabolic risk factors'],"['water intake', 'Greece and Spain increased their consumption of breakfast', 'daily consumption of sugary drinks', 'certain lifestyle behaviors', 'Lifestyle Changes']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",2110.0,0.0332343,"Participants allocated to the intervention group reduced their daily consumption of sugary drinks ( p =  0.037) and sweets ( p =  0.031) and their daily screen time ( p =  0.032), compared with the control group.","[{'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': 'Christina-Paulina', 'Initials': 'CP', 'LastName': 'Lambrinou', 'Affiliation': 'Department of Nutrition and Dietetics, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Mavrogianni', 'Affiliation': 'Department of Nutrition and Dietetics, Harokopio University, 17671 Athens, Greece.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Cardon', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, B-9000 Gent, Belgium.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Lindström', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, 00300 Helsinki, Finland.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Iotova', 'Affiliation': 'Department of Paediatrics, Medical University Varna, 9010 Varna, Bulgaria.'}, {'ForeName': 'Tsvetalina', 'Initials': 'T', 'LastName': 'Tankova', 'Affiliation': 'Department of Diabetology, Clinical Center of Endocrinology, Medical University Sofia, 1431 Sofia, Bulgaria.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Rurik', 'Affiliation': 'Department of Family and Occupational Medicine, University of Debrecen, 4032 Debrecen, Hungary.'}, {'ForeName': 'Vicky Van', 'Initials': 'VV', 'LastName': 'Stappen', 'Affiliation': 'Department of Movement and Sports Sciences, Faculty of Medicine and Health Sciences, Ghent University, B-9000 Gent, Belgium.'}, {'ForeName': 'Jemina', 'Initials': 'J', 'LastName': 'Kivelä', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, 00300 Helsinki, Finland.'}, {'ForeName': 'Rocío', 'Initials': 'R', 'LastName': 'Mateo-Gallego', 'Affiliation': 'Instituto Investigacion Sanitaria Aragon (IISA), CIBERCV, 50009 Zaragoza, Spain.'}, {'ForeName': 'Luis Α', 'Initials': 'LΑ', 'LastName': 'Moreno', 'Affiliation': 'Growth, Exercise, NUtrition and Development Research Group, School of Health Science (EUCS), University of Zaragoza, 50009 Zaragoza, Spain.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Makrilakis', 'Affiliation': 'First Department of Propaedeutic Medicine, Medical School, Laiko General Hospital, National and Kapodistrian University of Athens, 11527 Athens, Greece.'}, {'ForeName': 'Odysseas', 'Initials': 'O', 'LastName': 'Androutsos', 'Affiliation': 'Department of Nutrition and Dietetics, School of Physical Education, Sport Science and Dietetics, University of Thessaly, 42132 Trikala, Greece.'}]",Nutrients,['10.3390/nu12071949']
1506,32631820,Population Pharmacokinetics of Praziquantel in Pregnant and Lactating Filipino Women Infected with Schistosoma japonicum.,"An estimated 40 million women of reproductive age are infected with one of three species of the waterborne parasite  Schistosoma  spp. Treatment with praziquantel (PZQ) via mass drug administration (MDA) campaigns is the mainstay of schistosomiasis control for populations living in areas of endemicity. The World Health Organization recommends that pregnant and lactating women be included in schistosomiasis MDA programs, and several recent studies have evaluated the safety and efficacy of PZQ use during pregnancy. To date, there are no data describing PZQ pharmacokinetics (PK) during pregnancy or among lactating postpartum women. As part of a randomized controlled trial investigating the safety and efficacy of PZQ during human pregnancy, we examined the PK of this therapeutic drug among three distinct cohorts of women infected with  S. japonicum  in Leyte, Philippines. Specifically, we studied the PK properties of PZQ among early- and late-gestation pregnant women ( n  = 15 each) and lactating postpartum women ( n  = 15) with schistosomiasis. We found that women in early pregnancy had increased apparent clearance and lower area-under-the-curve (AUC 0-24 ) values that may be related to physiological changes in drug clearance and/or changes in oral bioavailability. There was no relationship between body weight and apparent clearance. The mean ± standard deviation partition ratio of plasma to breast milk was 0.36. ± 0.13. The estimated median infant PZQ daily dose would be 0.037 mg/kg of body weight ingested from breast milk, which is significantly lower than the dosage required for antischistosomal activity and not known to be harmful to the infant. Our PK data do not support the suggestion to delay breastfeeding 72 h after taking PZQ. Results can help inform future drug efficacy studies in pregnant and lactating women with schistosomiasis.",2020,There was no relationship between body weight and apparent clearance.,"['populations living in endemic areas', 'three distinct cohorts of women infected with  S. japonicum  in Leyte, The Philippines', 'among early and late gestation pregnant women (N= 15 each) and lactating post-partum women (N=15) with schistosomiasis', 'pregnant and lactating women with schistosomiasis', 'Pregnant and Lactating Filipino Women infected with  Schistosoma japonicum ', 'pregnant and lactating women', 'lactating postpartum women', '40 million women of reproductive age are infected with one of three species of the waterborne parasite  Schistosoma  ( S. ) spp']","['Praziquantel', 'praziquantel (PZQ) via mass drug administration (MDA) campaigns', 'PZQ']","['body weight and apparent clearance', 'PK properties of PZQ', 'mean ± standard deviation partition ratio of plasma to breast milk']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0454753', 'cui_str': 'Leyte'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0036323', 'cui_str': 'Disease due to Schistosomatidae'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C1556093', 'cui_str': 'Filipinos'}, {'cui': 'C0036317', 'cui_str': 'Schistosoma japonicum'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0036315', 'cui_str': 'Schistosoma'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0871161', 'cui_str': 'Property'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0026131', 'cui_str': 'Milk'}]",,0.0915495,There was no relationship between body weight and apparent clearance.,"[{'ForeName': 'Amaya L', 'Initials': 'AL', 'LastName': 'Bustinduy', 'Affiliation': 'Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, United Kingdom Amaya.Bustinduy@lshtm.ac.uk.'}, {'ForeName': 'Ruwanthi', 'Initials': 'R', 'LastName': 'Kolamunnage-Dona', 'Affiliation': 'Department of Biostatistics, University of Liverpool, Liverpool Health Partners, Liverpool, United Kingdom.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Mirochnick', 'Affiliation': 'Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts, USA.'}, {'ForeName': 'Edmund V', 'Initials': 'EV', 'LastName': 'Capparelli', 'Affiliation': 'Department of Pediatrics, University of California, San Diego, La Jolla, California, USA.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Tallo', 'Affiliation': 'Department of Epidemiology, Research Institute of Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Luz P', 'Initials': 'LP', 'LastName': 'Acosta', 'Affiliation': 'Department of Immunology, Research Institute of Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Remigio M', 'Initials': 'RM', 'LastName': 'Olveda', 'Affiliation': 'Department of Immunology, Research Institute of Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Jennifer F', 'Initials': 'JF', 'LastName': 'Friedman', 'Affiliation': 'Department of Pediatrics, Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Hope', 'Affiliation': 'Antimicrobial Pharmacodynamics and Therapeutics, University of Liverpool, Liverpool Health Partners, Liverpool, United Kingdom.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.00566-20']
1507,32639241,The 11th Trial of a Cardiovascular Clinical Trialist: Coronavirus-2: Part 2.,,2020,,[],[],[],[],[],[],,0.0214642,,"[{'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Frishman', 'Affiliation': 'Department of Medicine, New York Medical College/Westchester Medical Center, Valhalla, NY.'}]",Cardiology in review,['10.1097/CRD.0000000000000328']
1508,32639280,Predictive and prognostic value of magnesium serum level in FOLFIRI plus cetuximab or bevacizumab treated patients with stage IV colorectal cancer: results from the FIRE-3 (AIO KRK-0306) study.,"Magnesium wasting is a frequent side effect of epidermal growth factor receptor (EGFR)-antibody treatment as magnesium-absorption mechanisms are dependent on EGFR signaling. EGFR-inhibition results in decreased renal reabsorption. There is evidence that hypomagnesemia during cetuximab treatment correlates with response. The prognostic role of hypomagnesemia during bevacizumab treatment has not been studied yet. Here, we evaluate the prognostic value of hypomagnesemia in patients with metastatic colorectal cancer treated with FOLFIRI plus cetuximab or bevacizumab as first-line therapy. A total of 391 of 752 patients of the firstline irinotecan study population had magnesium levels measured at baseline and for the first three cycles (6 weeks) of treatment. Of those, 240 had Rat Sarkoma wildtype tumors. Overall hypomagnesemia was more common in the cetuximab compared to the bevacizumab arm (80 vs. 43%, P < 0.005). During therapy, magnesium showed a time-dependent decrease to 80% of baseline in the cetuximab and to 89% in the bevacizumab arm. Whereas magnesium continued to decrease over time in the cetuximab-treated patients, it remained stable in the bevacizumab-treated. Overall response rate (ORR) was associated with higher magnesium at week 6 (20.9 vs. 79.1%, P = 0.041). Bevacizumab-treated patients with magnesium levels below the median value at week 6 had a significantly longer progression-free survival (PFS; 11.7 vs. 9.9 months, P = 0.034; hazard ratio 0.73) and a trend towards longer overall survival (OS) (29.6 vs. 23.2 months, P = 0.089; hazard ratio 0.77). Hypomagnesemia at predefined time points and magnesium nadir had no significant effect on ORR, OS and PFS in the cetuximab arm. Our data show different magnesium kinetics in patients with metastatic colorectal cancer treated with cetuximab or bevacizumab. For patients treated with cetuximab, hypomagnesemia did not have an impact on response and survival. Hypomagnesemia might have a prognostic value in bevacizumab treatment.",2020,"Hypomagnesemia at predefined time points and magnesium nadir had no significant effect on ORR, OS and PFS in the cetuximab arm.","['treated patients with stage IV colorectal cancer', 'A total of 391 of 752 patients of the firstline irinotecan study population had', 'patients with metastatic colorectal cancer treated with', '240 had Rat Sarkoma wildtype tumors']","['FOLFIRI plus cetuximab or bevacizumab', 'cetuximab or bevacizumab', 'bevacizumab', 'Bevacizumab']","['ORR, OS and PFS', 'Overall response rate (ORR', 'renal reabsorption', 'progression-free survival', 'overall survival (OS', 'hypomagnesemia', 'Hypomagnesemia', 'Overall hypomagnesemia', 'prognostic value of hypomagnesemia', 'response and survival', 'magnesium levels']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0677950', 'cui_str': 'Colorectal cancer stage IV'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2610986', 'cui_str': 'Renal Absorption'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0202125', 'cui_str': 'Magnesium measurement, serum'}]",,0.154894,"Hypomagnesemia at predefined time points and magnesium nadir had no significant effect on ORR, OS and PFS in the cetuximab arm.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schulz', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Heinrich', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haas', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Julian W', 'Initials': 'JW', 'LastName': 'Holch', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Fraccaroli', 'Affiliation': 'Department of Medicine III, University Hospital, Ludwig Maximilian University (LMU), Munich.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess GmbH, Leverkusen.'}, {'ForeName': 'Jobst C', 'Initials': 'JC', 'LastName': 'von Einem', 'Affiliation': 'Division of Hematology, Oncology and Tumor Immunology (CCM), Department of Medicine, Charité - Universitaetsmedizin Berlin, Berlin.'}, {'ForeName': 'Dominik P', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'Division of Hematology, Oncology and Tumor Immunology (CCM), Department of Medicine, Charité - Universitaetsmedizin Berlin, Berlin.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Fischer von Weikersthal', 'Affiliation': 'Department of Hematology and Oncology, Gesundheitszentrum St. Marien, Amberg.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kullmann', 'Affiliation': 'Department of Medicine I, Klinikum Weiden, Weiden.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Moehler', 'Affiliation': 'Department of Medicine II, University Hospital, Johannes Gutenberg University Clinic Mainz, Mainz, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Scheithauer', 'Affiliation': 'Department of Internal Medicine I and Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jung', 'Affiliation': 'Institute of Pathology, University of Munich, Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Division of Hematology, Oncology and Tumor Immunology (CCM), Department of Medicine, Charité - Universitaetsmedizin Berlin, Berlin.'}]",Anti-cancer drugs,['10.1097/CAD.0000000000000965']
1509,32639688,Evaluation of the recovery outcome of poststroke cognitive impairment after cluster needling of scalp acupuncture therapy based on functional near-infrared spectroscopy.,"BACKGROUND


Cognitive impairment often arises in patients suffered from stroke. Acupuncture is a recommended treatment option for stroke by the World Health Organization (WHO) and has been shown to improve the cognitive function of patients with poststroke cognitive impairment (PSCI).
METHODS


In the present study, we assessed the efficacy of scalp acupuncture with cluster needling on PSCI patients. Fifty six PSCI patients were randomly separated into the reference group who received drug treatment only and the treatment group who received cluster needling of scalp acupuncture on top of drug treatment. Cognitive function was compared between the two groups before and after treatment. We also took the advantage of functional near-infrared spectroscopy to assess the cerebral hemoglobin levels.
RESULTS


We reveal that applying cluster needling of scalp acupuncture on top of drug treatment can significantly improve the cognitive function and elevate the cerebral hemoglobin levels compared to patients treated with drug only.
CONCLUSIONS


Our results suggest that cluster needling of scalp acupuncture is an effective treatment against PSCI and shed light on its application on other neurological disorders.",2020,Cognitive function was compared between the two groups before and after treatment.,"['patients suffered from stroke', 'PSCI patients', 'patients with poststroke cognitive impairment (PSCI', 'Fifty six PSCI patients']","['scalp acupuncture', 'scalp acupuncture with cluster needling', 'Acupuncture', 'scalp acupuncture therapy', 'cluster needling of scalp acupuncture']","['Cognitive function', 'cognitive function', 'cerebral hemoglobin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}]",56.0,0.0410108,Cognitive function was compared between the two groups before and after treatment.,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Jingge', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Heilongjiang University of Traditional Chinese Medicine, Harbin, China.'}]",Brain and behavior,['10.1002/brb3.1731']
1510,32634642,Evaluation of the perioperative effects of dexmedetomidine on tympanoplasty operations.,"PURPOSE


This randomized double-blind study aimed to evaluate the effects of dexmedetomidine on hemodynamic parameters and the quality of surgery and recovery criteria in tympanoplasty operations.
MATERIALS AND METHODS


A total of 75 patients 18-55 years undergoing tympanoplasty, who were graded as American Society of Anesthesiologists physical status I-II, were randomly divided into three groups. Group 1 included patients receiving remifentanil alone, Group 2 included patients receiving dexmedetomidine + remifentanil and Group 3 included patients receiving dexmedetomidine + ½ remifentanil. Anesthesia was induced with propofol and cisatracurium. For maintenance of anesthesia, a mixture of 2-2.5% sevoflurane, 40-60% oxygen/air was used. The groups were compared in terms of hemodynamic parameters, surgical area, recovery criteria, modified Aldrete, pain scores, additional analgesic requirements and adverse effects.
RESULTS


Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3. Surgical field satisfaction was higher in Group 2 and Group 3 than Group 1. Spontaneous breathing, eye opening and verbal cooperation times were shorter in Group 3 compared to Group 2. Eye opening and verbal cooperation times were longer in Group 2 compared to Group 1. The 30-minute modified Aldrete scores was higher in Group 3 compared to Group 1. There was no difference between the groups in terms of postoperative pain and adverse effects.
CONCLUSION


The use of dexmedetomidine during tympanoplasty operations may provide better hemodynamic control and surgical view, may provide faster recovery and may reduce remifentanil consumption.",2020,"Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3.","['75 patients 18-55\xa0years undergoing tympanoplasty, who were graded as American Society of Anesthesiologists physical status I-II']","['dexmedetomidine + ½ remifentanil', 'remifentanil alone', 'propofol and cisatracurium', 'sevoflurane', 'dexmedetomidine', 'dexmedetomidine + remifentanil']","['Eye opening and verbal cooperation times', 'Mean arterial pressure and heart rate values', 'Surgical field satisfaction', 'Spontaneous breathing, eye opening and verbal cooperation times', 'postoperative pain and adverse effects', 'hemodynamic parameters, surgical area, recovery criteria, modified Aldrete, pain scores, additional analgesic requirements and adverse effects', 'tympanoplasty operations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C1096766', 'cui_str': 'Cisatracurium'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",75.0,0.0542959,"Mean arterial pressure and heart rate values of Group 1 were higher at the time of intubation, incision, spontaneous breathing and extubation compared to Group 2 and Group 3.","[{'ForeName': 'Muge', 'Initials': 'M', 'LastName': 'Kosucu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anaesthesiology, 61080 Trabzon, Turkey. Electronic address: mugekk73@hotmail.com.'}, {'ForeName': 'Ersagun', 'Initials': 'E', 'LastName': 'Tugcugil', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Anaesthesiology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Bengu', 'Initials': 'B', 'LastName': 'Cobanoglu', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Otorhinolaryngology, 61080 Trabzon, Turkey.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Arslan', 'Affiliation': 'Medical School of Karadeniz Technical University, Department of Neurosurgery, 61080 Trabzon, Turkey.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102619']
1511,32634673,Ulipristal acetate versus gonadotropin-releasing hormone agonists prior to laparoscopic myomectomy (MYOMEX trial): Long term results of a double-blind randomized controlled trial.,"OBJECTIVE


The aim of this study was to compare the effect of ulipristal acetate (UPA) and gonadotropin-releasing hormone agonists (GnRHa) before laparoscopic myomectomy on long term secondary outcomes of the MYOMEX-trial, regarding quality of life, ultrasound characteristics, hemoglobin levels 6 weeks post-operative, sexual function and menstrual bleeding control. A cost-analysis was also performed. Short-term primary and secondary outcomes are reported elsewhere.
STUDY DESIGN


A double-blind, randomized, controlled, non-inferiority trial in nine hospitals in the Netherlands. Participants were randomized in a 1:1 ratio (block size of four, stratified per hospital) to either UPA or GnRHa pre-treatment. Additional placebo injections containing saline, respectively daily placebo tablets were given to both groups to ensure double-blinding. Surgery was performed within a month after the last tablet. Women were followed up until six months post-surgery.
RESULTS


A total of 55 participants were randomized: 30 to the UPA- and 25 to the GnRHa-group between May 2015 and July 2017. Uterine volume at six weeks post-operative did not differ significantly between both pre-treatment groups with 170.1 cm 3  (106.8-243.5; N = 29) vs. 152.8 cm 3  (92.3-205.6; N = 23) for the UPA- and GnRHa-group respectively (p = 0.423). Hemoglobin levels six weeks post-operatively recovered back to baseline and were not significantly different between groups with 7.7 mmol/L for the UPA- vs. 8.1 mmol/L for the GnRHa-group (p = 0.157; mean difference -0.4 (CI -0.9, 0.2). Menstrual bleeding pattern, quality of life, effects on general and sexual health showed a significant improvement compared to baseline in both groups without any differences between the treatment groups. Symptom severity scores also decreased significantly at 6 week post-operatively compared to baseline, but did not differ between the treatment groups. Fibroid characteristics at baseline (e.g. mean diameter of largest fibroid) appeared not to be a confounding factor. An exploratory cost analysis showed no significant differences in absenteeism costs, total healthcare and societal costs, after adjustment for confounding factors.
CONCLUSION


Pre-treatment prior to laparoscopic myomectomy with UPA compared to GnRHa has similar effects on bleeding pattern, menopausal symptoms, sexual functioning, symptom severity and quality of life from baseline up to six months post-operative. Due to the small sample size, these findings should be interpreted with caution. Also, no firm conclusions on costs could be made.",2020,"Menstrual bleeding pattern, quality of life, effects on general and sexual health showed a significant improvement compared to baseline in both groups without any differences between the treatment groups.","['prior to laparoscopic myomectomy (MYOMEX trial', 'A total of 55 participants were randomized: 30 to the UPA- and 25 to the GnRHa-group between May 2015 and July 2017', 'nine hospitals in the Netherlands']","['UPA or GnRHa pre-treatment', 'Ulipristal acetate versus gonadotropin-releasing hormone agonists', 'ulipristal acetate (UPA) and gonadotropin-releasing hormone agonists (GnRHa) before laparoscopic myomectomy', 'placebo injections containing saline, respectively daily placebo tablets']","['Fibroid characteristics', 'Hemoglobin levels', 'Menstrual bleeding pattern, quality of life, effects on general and sexual health', 'absenteeism costs, total healthcare and societal costs', 'bleeding pattern, menopausal symptoms, sexual functioning, symptom severity and quality of life', 'Symptom severity scores', 'Uterine volume', 'quality of life, ultrasound characteristics, hemoglobin levels 6 weeks post-operative, sexual function and menstrual bleeding control']","[{'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C2111517', 'cui_str': 'Laparoscopic myomectomy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2111517', 'cui_str': 'Laparoscopic myomectomy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",55.0,0.659859,"Menstrual bleeding pattern, quality of life, effects on general and sexual health showed a significant improvement compared to baseline in both groups without any differences between the treatment groups.","[{'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'De Milliano', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands.'}, {'ForeName': 'Mei-An', 'Initials': 'MA', 'LastName': 'Middelkoop', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands. Electronic address: m.middelkoop@amsterdamumc.nl.'}, {'ForeName': 'Judith A F', 'Initials': 'JAF', 'LastName': 'Huirne', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Kwee', 'Affiliation': 'OLVG, Department of Obstetrics and Gynecology, Jan Tooropstraat 164, Amsterdam, The Netherlands.'}, {'ForeName': 'Peggy M A J', 'Initials': 'PMAJ', 'LastName': 'Geomini', 'Affiliation': 'Máxima Medisch Centrum, Department of Obstetrics and Gynecology, De Run 4600, Veldhoven, The Netherlands.'}, {'ForeName': 'Benedictus C', 'Initials': 'BC', 'LastName': 'Schoot', 'Affiliation': 'Catharina Ziekenhuis, Department of Obstetrics and Gynecology, Michelangelolaan 2, Eindhoven, The Netherlands.'}, {'ForeName': 'Marchien', 'Initials': 'M', 'LastName': 'Van Baal', 'Affiliation': 'Flevoziekenhuis, Department Obstetrics and Gynecology, Hospitaalweg 1, Almere, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Wouter J K', 'Initials': 'WJK', 'LastName': 'Hehenkamp', 'Affiliation': 'Amsterdam University Medical Center, Department of Obstetrics and Gynecology, Amsterdam Reproduction and Development, De Boelelaan 1117, Amsterdam, The Netherlands. Electronic address: w.hehenkamp@amsterdamumc.nl.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.06.035']
1512,32643211,Randomised clinical trial of a motivational interviewing intervention to improve oral health education amongst older adults in Philadelphia: 12-month evaluation of non-clinical outcomes.,"OBJECTIVES


We conducted a trial to assess the treatment fidelity of an individual-based oral health education intervention utilising motivational interviewing (MI) techniques and its efficacy when compared to a group-based traditional oral health education intervention (TOHE) and a standard of care group (SC) in a sample from Philadelphia during a 12-month follow-up.
BACKGROUND


There is lack of information on how different types of oral health educational interventions affect older adults on non-clinical outcomes including changes in oral health-related quality of life (OHRQoL), oral health self-efficacy (SE) and oral health knowledge (OHK).
MATERIALS AND METHODS


One hundred and eighty patients were randomly allocated to TOHE, MI and SC groups. Treatment fidelity was measured in 16 non-study patients. The MI intervention was administered by a public health dental hygienist (PHDH). All interviews were audio-recorded and coded by an expert using the Motivational Interviewing Treatment Integrity (MITI) Code. Multivariable longitudinal regression analyses accounting for baseline demographics and correlated errors due to repeated measures via generalised estimating equation were conducted following an intention to treat approach.
RESULTS


Over the 1-year follow-up, SE and OHRQoL scores significantly improved amongst the MI group whereas both outcomes worsened amongst the SC group. During the same period, SE and OHRQoL did not change in the TOHE group.
CONCLUSION


Findings from the study support the fidelity of this intervention and the improvement of all non-clinical outcomes after 12 months amongst the MI group.",2020,"We conducted a trial to assess the treatment fidelity of an individual-based oral health education intervention utilising motivational interviewing (MI) techniques and its efficacy when compared to a group-based traditional oral health education intervention (TOHE) and a standard of care group (SC) in a sample from Philadelphia during a 12-month follow-up.
","['One hundred and eighty patients', 'older adults in Philadelphia', '16 non-study patients']","['motivational interviewing intervention', 'individual-based oral health education intervention utilising motivational interviewing (MI) techniques', 'traditional oral health education intervention (TOHE) and a standard of care group (SC', 'MI intervention', 'oral health educational interventions']","['Treatment fidelity', 'oral health-related quality of life (OHRQoL), oral health self-efficacy (SE) and oral health knowledge (OHK', 'SE and OHRQoL', 'oral health education']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0018703', 'cui_str': 'Oral health education'}]",180.0,0.0383083,"We conducted a trial to assess the treatment fidelity of an individual-based oral health education intervention utilising motivational interviewing (MI) techniques and its efficacy when compared to a group-based traditional oral health education intervention (TOHE) and a standard of care group (SC) in a sample from Philadelphia during a 12-month follow-up.
","[{'ForeName': 'Marisol', 'Initials': 'M', 'LastName': 'Tellez', 'Affiliation': 'Maurice H Kornberg School of Dentistry, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Shanon', 'Initials': 'S', 'LastName': 'Myers Virtue', 'Affiliation': 'Helen F. Graham Cancer Center & Research Institute Christiana Care Health System, Newark, Delaware, USA.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Neckritz', 'Affiliation': 'Maurice H Kornberg School of Dentistry, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Sungwoo', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Maurice H Kornberg School of Dentistry, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Vinodh', 'Initials': 'V', 'LastName': 'Bhoopathi', 'Affiliation': 'Maurice H Kornberg School of Dentistry, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Hernandez', 'Affiliation': 'Colgate Palmolive Company, Toronto, ON, Canada.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Shearer', 'Affiliation': 'Colgate Palmolive Company, New York, New York, USA.'}, {'ForeName': 'Amid', 'Initials': 'A', 'LastName': 'Ismail', 'Affiliation': 'Maurice H Kornberg School of Dentistry, Philadelphia, Pennsylvania, USA.'}]",Gerodontology,['10.1111/ger.12488']
1513,32648390,[ Yin - yang  balance penetrating acupuncture combined with rehabilitation training on upper limb spasticity in stroke hemiplegia].,"OBJECTIVE


To compare the therapeutic effect of  yin - yang  balance penetrating acupuncture combined with rehabilitation training and single rehabilitation training on upper limb spasticity in patients with stroke hemiplegia.
METHODS


A total of 60 patients with upper limb spasticity of stroke hemiplegia were randomized into an observation group and a control group, 30 cases in each one. On the basis of conventional western medication, rehabilitation training was adopted in the control group. On the basis of treatment in the control group,  yin - yang  balance penetrating acupuncture was applied from Jianyu (LI 15) to Binao (LI 14), Quchi (LI 11) to Shaohai (HT 3), Yanglingquan (GB 34) to Yinlingquan (SP 9), Xuanzhong (GB 39) to Sanyinjiao (SP 6), etc. of the affected side in the observation group. The treatment was given once a day, 5 days were as one course, with a 2-day interval between two courses, 4 courses were required in both groups. The classification of modified Ashworth spasticity scale (MAS), surface integrated electromyogram (iEMG) of affected upper limb and the scores of National Institute of Health stroke scale (NIHSS), Fugl-Meyer assessment (FMA) of upper limb and modified Barthel index (MBI) before and after treatment were observed, the therapeutic effect was evaluated in both groups.
RESULTS


①After treatment, the MAS classification reduced in both groups ( P <0.05), the cases of grade 0 to Ⅰ +  in the observation group were more than those in the control group ( P <0.05); iEMG values of the maximum isometric voluntary contraction of affected usculus biceps brachii, musculus triceps brachii, musculus flexor carpi, musculus extensor carpi, extensor digitorum, aductor pollicis brevis were increased in both groups ( P <0.05), and the variations of iEMG of above muscles on the affected side in the observation group were larger than those in the control group ( P <0.05). ②After treatment, the scores of NIHSS were decreased ( P <0.05), the scores of FMA, MBI were increased in both groups ( P <0.05), and the variations of NIHSS, FMA and MBI scores were larger than those in the control group ( P <0.05). ③The total effective rate was 93.3% (28/30) in the observation group, which was superior to 70.0% (21/30) in the control group ( P <0.05).
CONCLUSION


Yin - yang  balance penetrating acupuncture combined with rehabilitation training can improve upper limb spasticity, heighten the motor function of upper limb and daily self care in patients with stroke hemiplegia, its therapeutic effect is superior to single rehabilitation training.",2020,"①After treatment, the MAS classification reduced in both groups ( P <0.05), the cases of grade 0 to Ⅰ +  in the observation group were more than those in the control group ( P <0.05); iEMG values of the maximum isometric voluntary contraction of affected usculus biceps brachii, musculus triceps brachii, musculus flexor carpi, musculus extensor carpi, extensor digitorum, aductor pollicis","['60 patients with upper limb spasticity of stroke hemiplegia', 'stroke hemiplegia', 'patients with stroke hemiplegia']","['yin - yang  balance penetrating acupuncture combined with rehabilitation training and single rehabilitation training', 'Yin - yang  balance', 'penetrating acupuncture combined with rehabilitation training', ' Yin - yang  balance penetrating acupuncture combined with rehabilitation training']","['total effective rate', 'variations of iEMG of above muscles on the affected side', 'MAS classification', 'variations of NIHSS, FMA and MBI scores', 'scores of NIHSS', 'scores of FMA, MBI', 'maximum isometric voluntary contraction of affected usculus biceps brachii, musculus triceps brachii, musculus flexor carpi, musculus extensor carpi, extensor digitorum, aductor pollicis', 'modified Ashworth spasticity scale (MAS), surface integrated electromyogram (iEMG) of affected upper limb and the scores of National Institute of Health stroke scale (NIHSS), Fugl-Meyer assessment (FMA) of upper limb and modified Barthel index (MBI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018991', 'cui_str': 'Hemiplegia'}]","[{'cui': 'C0085256', 'cui_str': 'Yin-Yang'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0025048', 'cui_str': 'Meconium aspiration syndrome'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0224268', 'cui_str': 'Structure of extensor digitorum muscle of hand'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}]",60.0,0.0161392,"①After treatment, the MAS classification reduced in both groups ( P <0.05), the cases of grade 0 to Ⅰ +  in the observation group were more than those in the control group ( P <0.05); iEMG values of the maximum isometric voluntary contraction of affected usculus biceps brachii, musculus triceps brachii, musculus flexor carpi, musculus extensor carpi, extensor digitorum, aductor pollicis","[{'ForeName': 'Jin-Mei', 'Initials': 'JM', 'LastName': 'Zhu', 'Affiliation': ""Rehabilitation Center, De'an Hospital of Changzhou City, Changzhou 213000, Jiangsu Province, China.""}, {'ForeName': 'Ren', 'Initials': 'R', 'LastName': 'Zhuang', 'Affiliation': ""Rehabilitation Center, De'an Hospital of Changzhou City, Changzhou 213000, Jiangsu Province, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Rehabilitation Center, De'an Hospital of Changzhou City, Changzhou 213000, Jiangsu Province, China.""}, {'ForeName': 'Xue-Xin', 'Initials': 'XX', 'LastName': 'Wang', 'Affiliation': ""Rehabilitation Center, De'an Hospital of Changzhou City, Changzhou 213000, Jiangsu Province, China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Rehabilitation Center, De'an Hospital of Changzhou City, Changzhou 213000, Jiangsu Province, China.""}, {'ForeName': 'Hai-Ying', 'Initials': 'HY', 'LastName': 'Zhu', 'Affiliation': ""Rehabilitation Center, De'an Hospital of Changzhou City, Changzhou 213000, Jiangsu Province, China.""}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190531-k0005']
1514,32648391,[Therapeutic effect of herb-separated moxibustion at Jinsuo (GV 8)-eight-diagram points on diarrhea-type irritable bowel syndrome of liver stagnation and spleen deficiency].,"OBJECTIVE


To observe the clinical therapeutic effect of herb-separated moxibustion at Jinsuo (GV 8)- eight-diagram points on diarrhea-type irritable bowel syndrome (IBS-D) of liver stagnation and spleen deficiency as compared with oral administration of pinaverium bromide tablets and Chinese herbal decoction,  tongxieyaofang .
METHODS


A total of 126 patients with IBS-D of liver stagnation and spleen deficiency were randomized into a herb-separated moxibustion group (moxibustion group), a western medication group and a Chinese herbal medication group, 42 cases in each one. In the moxibustion group, the herb-separated moxibustion was applied to Jinsuo (GV 8)-eight-diagram points. The herbs in  tongxieyaofang  (fried  rhizoma atractylodis macrocephalae , fried  radix paeoniae alba ,  pericarpium citri reticulatae  and  radix saposhnikoviae ) were ground into herbal paste and the paste was put on Jinsuo (GV 8)-eight-diagram points. The suspending moxibustion was exerted over the points for 40 min, once daily. In the western medication group, pinaverium bromide tablets were taken orally, 50 mg each time, three times a day. In the Chinese herbal medication group, the decoction of  tongxieyaofang  was taken orally, one dose a day, taking separately in two times. The duration of treatment was 8 weeks in each group. Before and after treatment, the symptom score of traditional Chinese medicine (TCM), gastrointestinal (GI) symptom score, the score of IBS symptom severity scale (IBS-SSS) and the score of IBS quality of life (IBS-QOL) scale were observed in patients of each group separately. The clinical therapeutic effect was evaluated.
RESULTS


After treatment, the scores of TCM symptoms, GI symptom scores and IBS-SSS scores were all obviously reduced in each group ( P <0.05). Each of the scores in the moxibustion group was lower than the western medication group and the Chinese herbal medication group respectively ( P <0.05). After treatment, the scores of each of eight subscale structures of IBS-QOL scale, named dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual intercourse and relationship, were all increased obviously in each group ( P <0.05). The scores of each of eight subscale structures in the moxibustion group were higher than the western medication group and the Chinese herbal medication group respectively ( P <0.05). The total effective rate was 92.9% (39/42) in the moxibustion group, higher than 71.4% (30/42) in the western medication group and 73.8% (31/42) in the Chinese herbal medication group respectively ( P <0.05).
CONCLUSION


Herb-separated moxibustion at Jinsuo (GV 8)-eight-diagram points remarkably relieves gastrointestinal symptoms and improves the quality of life in patients of diarrhea-type irritable bowel syndrome of liver stagnation and spleen deficiency, and its clinical therapeutic effect is superior to oral administration of either pinaverium bromide tablets or  tongxieyaofang .",2020,Each of the scores in the moxibustion group was lower than the western medication group and the Chinese herbal medication group respectively ( P <0.05).,"['126 patients with IBS-D of liver stagnation and spleen deficiency', 'diarrhea-type irritable bowel syndrome of liver stagnation and spleen deficiency', 'diarrhea-type irritable bowel syndrome (IBS-D) of liver stagnation and spleen deficiency']","['pinaverium bromide tablets', 'Herb-separated moxibustion at Jinsuo (GV 8)-eight-diagram points', 'pinaverium bromide tablets or  tongxieyaofang ', 'herb-separated moxibustion at Jinsuo (GV 8)-eight-diagram points', 'herb-separated moxibustion at Jinsuo (GV 8)- eight-diagram points', 'pinaverium bromide tablets and Chinese herbal decoction,  tongxieyaofang ', 'herb-separated moxibustion', 'herb-separated moxibustion group (moxibustion group), a western medication group and a Chinese herbal medication']","['symptom score of traditional Chinese medicine (TCM), gastrointestinal (GI) symptom score, the score of IBS symptom severity scale (IBS-SSS) and the score of IBS quality of life (IBS-QOL) scale', 'scores of TCM symptoms, GI symptom scores and IBS-SSS scores', 'quality of life', 'total effective rate', 'gastrointestinal symptoms', 'scores of each of eight subscale structures of IBS-QOL scale, named dysphoria, interference with activity, body image, health worry, food avoidance, social reaction, sexual intercourse and relationship', 'scores of each of eight subscale structures']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0037993', 'cui_str': 'Splenic structure'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0137073', 'cui_str': 'Pinaverium bromide'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037052', 'cui_str': 'Sick sinus syndrome'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0233477', 'cui_str': 'Dysphoric mood'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",126.0,0.0203212,Each of the scores in the moxibustion group was lower than the western medication group and the Chinese herbal medication group respectively ( P <0.05).,"[{'ForeName': 'Li-Jun', 'Initials': 'LJ', 'LastName': 'Hao', 'Affiliation': 'Department of Gastroenterology, Tangshan Gongren Hospital, Tangshan 063000, Hebei Province, China.'}, {'ForeName': 'Zhi-Min', 'Initials': 'ZM', 'LastName': 'Shi', 'Affiliation': 'Department of Spleen and Stomach Disorders, Tangshan Chinese Medicine Hospital, Tangshan 063000, Hebei Province.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190621-k0007']
1515,32648392,[Effect of acupuncture and estazolam on episodic memory and sleep structure in patients with chronic insomnia disorder: a randomized controlled trial].,"OBJECTIVE


To compare the effect on chronic insomnia disorder (CID) and influences on episodic memory and sleep structure between acupuncture and estazolam tablets.
METHODS


A total of 140 CID patients were randomized into a meridian-point group (46 cases, 1 case dropped off), a non-meridian-and-non-acupoint group (47 cases, 2 cases dropped off) and a medication group (47 cases, 2 cases dropped off). In the meridian-point group, Baihui (GV 20), Shenmen (HT 7), Sanyinjiao (SP 6), Zhaohai (KI 6) and Shenmai (BL 62) were selected and the routine acupuncture was applied. In the non-meridian-and-non-acupoint group, the needling technique was same as the meridian-point group. Acupuncture was given once daily for 4 weeks in the above two groups. In the medication group, estazolam tablets were administered orally, taken 1 to 2 mg per night, consecutively for 4 weeks. Before and after treatment, the changes in the following indexes were observed in each group, i.e. the score of insomnia severity index (ISI), the score of auditory verbal memory test (AVMT) and the relevant indexes of sleep structure [total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE) and the percentage of non rapid eye movement phase 1, 2 and 3 (N1, N2 and N3) and rapid eye movement time (REM) in TST].
RESULTS


After treatment, ISI scores were reduced in the meridian-point group and the medication group ( P <0.01), the score in the meridian-point group was lower than the medication group and the non-meridian-and-non- acupoint group respectively ( P <0.01) and that in the medication group was lower than the non-meridian-and-non-acupoint group ( P <0.01). After treatment, the score of each of immediate recall, short-term delayed recall, long-term delayed recall and delayed recognition of AVMT was increased in the meridian-point group and the medication group respectively ( P <0.01,  P <0.05) and the score of each item of AVMT in the meridian-point group was higher than the medication group and the non-meridian-and-non-acupoint group respectively ( P <0.01,  P <0.05). The scores of immediate memory and delayed recognition in the medication group were higher than the non-meridian-and-non-acupoint group respectively ( P <0.01). After treatment, SOL, WASO and N1% were all reduced ( P <0.01) and TST, SE, N3% and REM% were all increased ( P <0.01,  P <0.05) in the meridian-point group and the medication group, N2% in the meridian-point group was reduced ( P <0.01). After treatment, N1% and N2% in the meridian-point group were lower than the medication group ( P <0.01) and N3% and REM% were higher than the medication group ( P <0.01). After treatment, TST, SE and N3% in the meridian-point group and the medication group were all higher than the non-meridian-and-non-acupoint group respectively ( P <0.01,  P <0.05) and SOL, WASO and N1% were lower than the non-meridian-and-non-acupoint group respectively ( P <0.01). REM% in the meridian-point group was also higher than the non-meridion-and-non-acupoint group ( P <0.01), and N2% in the meridian-point group was also lower than the non-meridian-and-non-acupoint group ( P <0.01).
CONCLUSION


Compared with estazolam, acupuncture much better improves sleep quality and episodic memory in patients with chronic insomnia disorder, which is possibly related to the regulation of sleep structure of patients in treatment with acupuncture.",2020,"After treatment, N1% and N2% in the meridian-point group were lower than the medication group ( P <0.01) and N3% and REM% were higher than the medication group ( P <0.01).","['140 CID patients', 'patients with chronic insomnia disorder']","['acupuncture and estazolam tablets', 'estazolam tablets', 'acupuncture', 'acupuncture and estazolam', 'Acupuncture', 'estazolam, acupuncture', 'non-meridian-and-non-acupoint']","['sleep quality and episodic memory', 'ISI scores', 'score of each item of AVMT', 'score of insomnia severity index (ISI), the score of auditory verbal memory test (AVMT) and the relevant indexes of sleep structure [total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE) and the percentage of non rapid eye movement phase 1, 2 and 3 (N1, N2 and N3) and rapid eye movement time (REM', 'score of each of immediate recall, short-term delayed recall, long-term delayed recall and delayed recognition of AVMT', 'chronic insomnia disorder (CID', 'scores of immediate memory and delayed recognition', 'TST, SE, N3% and REM', 'REM', 'episodic memory and sleep structure']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1246115', 'cui_str': 'Estazolam Oral Tablet'}, {'cui': 'C0014892', 'cui_str': 'Estazolam'}, {'cui': 'C0085282', 'cui_str': 'Jingluo'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0015413', 'cui_str': 'Eye Movements'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0242393', 'cui_str': 'Immediate Recall'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",140.0,0.017784,"After treatment, N1% and N2% in the meridian-point group were lower than the medication group ( P <0.01) and N3% and REM% were higher than the medication group ( P <0.01).","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': 'Department of TCM, Hangzhou Red-Cross Hospital, Hangzhou 310003, Zhejiang Province, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Psychosomatics, Seventh Hangzhou People's Hospital, Hangzhou 310013, Zhejiang Province.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of TCM, Hangzhou Red-Cross Hospital, Hangzhou 310003, Zhejiang Province, China.'}, {'ForeName': 'Yi-Hui', 'Initials': 'YH', 'LastName': 'Liu', 'Affiliation': 'Department of TCM, Hangzhou Red-Cross Hospital, Hangzhou 310003, Zhejiang Province, China.'}, {'ForeName': 'Guang-Lie', 'Initials': 'GL', 'LastName': 'Chen', 'Affiliation': ""Department of Psychosomatics, Seventh Hangzhou People's Hospital, Hangzhou 310013, Zhejiang Province.""}, {'ForeName': 'Wen-Juan', 'Initials': 'WJ', 'LastName': 'Liu', 'Affiliation': ""Department of Psychosomatics, Seventh Hangzhou People's Hospital, Hangzhou 310013, Zhejiang Province.""}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20191208-k0006']
1516,32634485,Virtual mind-body treatment for adolescents with neurofibromatosis: Study protocol for a single-blind randomized controlled trial.,"BACKGROUND


Neurofibromatoses (NF) are a group of genetically distinct disorders of the nervous system unified by the predisposition to nerve sheath tumors. Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of life and high psychosocial burden, there are no evidence-based interventions to address these needs. This paper presents the study design and protocol for the first randomized controlled trial (RCT) of a mind-body intervention for adolescents with NF, Resilient Youth with NF (RY-NF), versus an educational control group, Health Education for NF (HE-NF), both delivered in groups via secure live video.
METHODS


This is an ongoing, single-blind efficacy RCT. Recruitment began in November 2019 and will continue until March 2022. We will enroll 200 English-speaking, geographically diverse adolescents (ages 12-17) with NF1 and NF2 who report significant distress or difficulty coping with their NF symptoms. We will use a shared-baseline, linear mixed model to compare the effect of RY-NF versus HE-NF on changes in quality of life (QoL) and psychosocial outcomes from baseline to post-intervention, and 6- and 12-month follow-ups. We will also develop NF-specific minimal clinically important difference (MCID) for QoL variables, and conduct mediation and moderation analyses to understand mechanisms of improvement.
DISCUSSION


This study has important clinical and public health implications for the psychosocial functioning of adolescents with NF. It provides a model for efficient delivery of virtual psychosocial care for adolescents with rare diseases. Plans for dissemination and implementation of the RY-NF should efficacy be ascertained are also discussed.",2020,"Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of life and high psychosocial burden, there are no evidence-based interventions to address these needs.","['adolescents with NF, Resilient Youth with NF (RY-NF', 'adolescents with neurofibromatosis', 'adolescents with NF', 'adolescents with rare diseases', '200 English-speaking, geographically diverse adolescents (ages 12-17) with NF1 and NF2 who report significant distress or difficulty coping with their NF symptoms']","['educational control group, Health Education for NF (HE-NF', 'Virtual mind-body treatment', 'mind-body intervention', 'RY-NF versus HE-NF']",['quality of life (QoL) and psychosocial outcomes'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0027831', 'cui_str': 'Neurofibromatosis type 1'}, {'cui': 'C0678236', 'cui_str': 'Rare Diseases'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027832', 'cui_str': 'Neurofibromatosis type 2'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0582154', 'cui_str': 'Difficulty coping'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1513305', 'cui_str': 'Mind-Body Medicine'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0666435,"Although adolescents with NF types 1 and 2 (NF1 and NF2) report poor quality of life and high psychosocial burden, there are no evidence-based interventions to address these needs.","[{'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Reichman', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, One Bowdoin, Square, 1st floor Boston, 02114 Boston, MA, United States of America. Electronic address: mreichman@mgh.harvard.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Riklin', 'Affiliation': 'Department of Psychology, Fordham University, Dealy 336, 441 East Fordham Rd, Bronx, NY 10458, United States of America. Electronic address: eriklin@fordham.edu.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Macklin', 'Affiliation': 'Biostatistics Center, Massachusetts General Hospital, 50 Staniford Street, St 560, Boston, MA 02114, United States of America. Electronic address: emacklin@mgh.harvard.edu.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Integrated Brain Health Clinical and Research Program, Psychiatry Department, Massachusetts General Hospital, One Bowdoin, Square, 1st floor Boston, 02114 Boston, MA, United States of America; Harvard Medical School, One Bowdoin Square, 1st floor Boston, 02114 Boston, MA, United States of America. Electronic address: avranceanu@mgh.harvard.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106078']
1517,32634486,Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes.,"BACKGROUND


Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups. The shared medical appointment (SMA) model has been effective in multiple healthcare populations, but the feasibility and effectiveness of SMA in AYA patients with T1D is unclear.
METHODS


This research leverages the team's multidisciplinary expertise to develop an engaging intervention toolkit and test the implementation of the Team Clinic care model for the treatment of T1D among middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population. In Phase 1, the team will manualize the Team Clinic care model into an engaging, age-appropriate educational and intervention toolkit. In Phase 2, the team will conduct a randomized clinical trial to test the feasibility and usability of the toolkit from the provider perspective (team member satisfaction; clinical efficiency; compliance with American Diabetes Association, American Association of Diabetes Educators, and California Children's Services standards; and payor-level cost data) and the preliminary efficacy of the intervention toolkit on patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression).
DISCUSSION


AYA patients with T1D often receive care in clinics and institutions with limited resources and time. This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards. Trial registration The study is registered with ClinicalTrials.gov (Protocol Record: NCT04190368).",2020,"This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards.","['Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups', 'adolescents with type 1 diabetes', 'patients with T1D often receive care in clinics and institutions with limited resources and time', ""middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population""]",[],"['patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0233542', 'cui_str': 'Family conflict'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0267749,"This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards.","[{'ForeName': 'Sarah-Jeanne', 'Initials': 'SJ', 'LastName': 'Salvy', 'Affiliation': 'Research Center for Health Equity, Cedars-Sinai Medical Center, United States of America.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Ruelas', 'Affiliation': 'Keck School of Medicine, University of Southern California, United States of America.'}, {'ForeName': 'Shideh', 'Initials': 'S', 'LastName': 'Majidi', 'Affiliation': 'School of Medicine, University of Colorado Anschutz Medical Campus, United States of America.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'Booster Shot Media, United States of America.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Ashwal', 'Affiliation': 'Booster Shot Media, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Reid', 'Affiliation': ""The Vision Center, Children's Hospital Los Angeles, United States of America.""}, {'ForeName': 'D Steven', 'Initials': 'DS', 'LastName': 'Fox', 'Affiliation': 'School of Pharmacy, University of Southern California, United States of America.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'McClain', 'Affiliation': 'School of Social Work, University of Southern California, United States of America.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Raymond', 'Affiliation': ""Center for Endocrinology, Diabetes, & Metabolism, Children's Hospital Los Angeles, United States of America. Electronic address: jraymond@chla.usc.edu.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106079']
1518,32634551,Effects of resistance training on hepcidin levels and iron bioavailability in older individuals with end-stage renal disease: A randomized controlled trial.,"Anemia is an inherent complication of older individuals with end-stage renal disease (ESRD) that is associated with inflammation which in turn is an important factor in the activation of hepcidin that contributes to the decrease in serum iron. Athough resistance training (RT) seems to reduce inflammation in ESRD, its influence on hepcidin and iron availability in hemodialysis patients is unclear. Therefore, the aim of this study was to exemine the effects of RT in on inflammatory profile, hepcidin, and iron status in older individuals with ESRD. End-stage renal disease patients (N: 157, age: 66.8 ± 3.6; body mass: 73 ± 15 body mass index:27 ± 3), were assigned to control (CTL n: 76) and exercise groups (RT n: 81). RT consisted of 24 weeks/3 days per week of a moderate intensity. There was an increase in the bioavailability of iron (ΔRT: 22.2; ΔCTL: -1 μg/dL, p < 0.0001), a decrease in hepcidin levels (ΔRT: -7.9; ΔCTL: 0.2 ng/mL, p < 0.0001),and an improvement of the inflammatory profile. These novel findings show that RT is a potential coadjuvant to reduce iron deficiency by decreasing the levels of hepcidin and pro-inflammatory markers in older patients undergoing hemodialysis.",2020,"There was an increase in the bioavailability of iron (ΔRT: 22.2; ΔCTL: -1 μg/dL, p < 0.0001), a decrease in hepcidin levels (ΔRT: -7.9; ΔCTL: 0.2 ng/mL, p < 0.0001),and an improvement of the inflammatory profile.","['N: 157, age: 66.8\u202f±\u202f3.6; body mass: 73\u202f±\u202f15 body mass index:27\u202f±\u202f3', 'older individuals with ESRD', 'older individuals with end-stage renal disease', 'older individuals with end-stage renal disease (ESRD', 'older patients undergoing hemodialysis', 'hemodialysis patients', 'End-stage renal disease patients']","['Athough resistance training (RT', 'RT', 'resistance training']","['inflammatory profile, hepcidin, and iron status', 'hepcidin levels and iron bioavailability', 'hepcidin levels', 'bioavailability of iron']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",157.0,0.0490397,"There was an increase in the bioavailability of iron (ΔRT: 22.2; ΔCTL: -1 μg/dL, p < 0.0001), a decrease in hepcidin levels (ΔRT: -7.9; ΔCTL: 0.2 ng/mL, p < 0.0001),and an improvement of the inflammatory profile.","[{'ForeName': 'Sting Ray Gouveia', 'Initials': 'SRG', 'LastName': 'Moura', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Hugo Luca', 'Initials': 'HL', 'LastName': 'Corrêa', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil. Electronic address: hugo.efucb@gmail.com.'}, {'ForeName': 'Rodrigo Vanerson Passos', 'Initials': 'RVP', 'LastName': 'Neves', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Cláudio Avelino Rodrigues', 'Initials': 'CAR', 'LastName': 'Santos', 'Affiliation': 'Federal University of Tocantins, Medicine Department, Tocantins, Brazil.'}, {'ForeName': 'Luiz Sinésio Silva', 'Initials': 'LSS', 'LastName': 'Neto', 'Affiliation': 'Federal University of Tocantins, Medicine Department, Tocantins, Brazil.'}, {'ForeName': 'Victor Lopes', 'Initials': 'VL', 'LastName': 'Silva', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Michel Kendy', 'Initials': 'MK', 'LastName': 'Souza', 'Affiliation': 'Federal University of Tocantins, Medicine Department, Tocantins, Brazil.'}, {'ForeName': 'Lysleine Alves', 'Initials': 'LA', 'LastName': 'Deus', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Andrea Lucena', 'Initials': 'AL', 'LastName': 'Reis', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Herbert Gustavo', 'Initials': 'HG', 'LastName': 'Simões', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Fabiani Lage Rodrigues', 'Initials': 'FLR', 'LastName': 'Beal', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Milton Rocha', 'Initials': 'MR', 'LastName': 'Moraes', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Navalta', 'Affiliation': 'University of Nevada, Las Vegas, Department of Kinesiology and Nutrition Sciences, Las Vegas, NV, USA.'}, {'ForeName': 'Jonato', 'Initials': 'J', 'LastName': 'Prestes', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'André Bonadias', 'Initials': 'AB', 'LastName': 'Gadelha', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil; Federal Institute of Education, Science and Technology Goiano, Goiás, Brazil.'}, {'ForeName': 'Thiago Dos Santos', 'Initials': 'TDS', 'LastName': 'Rosa', 'Affiliation': 'Catholic University of Brasilia, Federal District, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2020.111017']
1519,32634571,Pharmacokinetic investigation of synthetic cannabidiol oral formulations in healthy volunteers.,"Recent advances in the research of medicinal cannabis has placed the non-intoxicating cannabinoid cannabidiol (CBD) at the front of scientific research. The reasons behind this popularity is the compound's therapeutic properties, alongside a safe profile of administration lacking addictive properties such as euphoric state of mind and a wide dosing range. Oral administration of CBD is challenging due to poor solubility in the gastro-intestinal system and susceptibility to extensive first pass metabolism. As a result, the practice in clinic and investigational trials is to administer cannabinoids in edible oils or oil-based solutions. Nonetheless, reported pharmacokinetics of cannabinoids and CBD in particular are not uniform among research groups and are affected by the vehicle of administration. The purpose of the work presented here is to investigate oral absorption processes of synthetic CBD when given in different oral formulations in healthy volunteers. The study design was a three way, blind, cross-over single administration study of 12 healthy male volunteers. CBD was administered in powder form, dissolved in sesame oil and in self-nano-emulsifying drug delivery system (SNEDDS). Administration of CBD in lipid-based vehicles resulted in a significant increase in C max  and AUC of CBD, as compared to powder form. Overall plasma exposure of CBD did not differ between sesame oil vehicle and the SNEDDS formulation. However, administration of CBD in pure oil resulted in two absorption behaviors of early and delayed absorption among subjects, as opposed to SNEDDS platform that resulted in a uniform early absorption profile. Results of this trial demonstrate the importance of solubilization process of lipophilic drugs such as CBD and demonstrated the ability of the nano formulation to achieve a reliable, predictable PK profile of the drug. These findings offer a standardized oral formulation for the delivery of cannabinoids and contribute data for the growing field of cannabinoid pharmacokinetics.",2020,"Administration of CBD in lipid-based vehicles resulted in a significant increase in Cmax and AUC of CBD, as compared to powder form.","['Healthy Volunteers', 'healthy volunteers', '12 healthy male volunteers']","['synthetic CBD', 'Synthetic Cannabidiol Oral Formulations', 'CBD']","['absorption behaviors of early and delayed absorption', 'Overall plasma exposure of CBD', 'Cmax and AUC of CBD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",12.0,0.0381526,"Administration of CBD in lipid-based vehicles resulted in a significant increase in Cmax and AUC of CBD, as compared to powder form.","[{'ForeName': 'Dvora', 'Initials': 'D', 'LastName': 'Izgelov', 'Affiliation': 'Institute for Drug Research, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, P.O. Box 12065, Jerusalem 91120, Israel.'}, {'ForeName': 'Elyad', 'Initials': 'E', 'LastName': 'Davidson', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.'}, {'ForeName': 'Dinorah', 'Initials': 'D', 'LastName': 'Barasch', 'Affiliation': 'Institute for Drug Research, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, P.O. Box 12065, Jerusalem 91120, Israel.'}, {'ForeName': 'Aviva', 'Initials': 'A', 'LastName': 'Regev', 'Affiliation': 'PureForm Biosciences, Los Angeles, CA, United States.'}, {'ForeName': 'Abraham J', 'Initials': 'AJ', 'LastName': 'Domb', 'Affiliation': 'Institute for Drug Research, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, P.O. Box 12065, Jerusalem 91120, Israel.'}, {'ForeName': 'Amnon', 'Initials': 'A', 'LastName': 'Hoffman', 'Affiliation': 'Institute for Drug Research, School of Pharmacy, Faculty of Medicine, The Hebrew University of Jerusalem, P.O. Box 12065, Jerusalem 91120, Israel. Electronic address: amnonh@ekmd.huji.ac.il.'}]",European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V,['10.1016/j.ejpb.2020.06.021']
1520,32634745,"Examining sex, adverse childhood experiences, and oxytocin on neuroendocrine reactivity in smokers.","Adverse childhood experiences (ACE) are associated with greater neuroendocrine responses to social stress in substance users. The neuropeptide oxytocin might attenuate this relationship. Given sex differences in ACE exposure and neuroendocrine stress reactivity, it is unknown whether this association is similar for males and females. Therefore, this secondary analysis evaluated the interactive effect of sex, ACE, and acute oxytocin administration on neuroendocrine stress responses in adult cigarette smokers (N = 144). Participants completed the Adverse Childhood Experiences Questionnaire at screening and were randomized to receive intranasal oxytocin or placebo before undergoing the Trier Social Stress Task (TSST). Cortisol levels were assessed at pre- and post-medication administration and at 20 and 40 min following the TSST. Generalized linear mixed models were developed to predict post-TSST cortisol levels. Predictors included treatment assignment (placebo vs. oxytocin), sex (male vs. female), ACE (0-10 total score), pre-medication cortisol levels, and minutes since medication administration. The hypothesized three-way interaction between sex, oxytocin, and ACE scores was significant. Linear associations between ACE scores and cortisol reactivity indicated higher ACE scores were associated with attenuated cortisol response in females, regardless of treatment condition. For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin. Results indicate that the association between ACE and neuroendocrine reactivity to social stress, as well as the attenuating effect of oxytocin, is differentially impacted by sex. Males with greater childhood adversity may be more likely to benefit from oxytocin's anxiolytic properties.",2020,"For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin.","['adult cigarette smokers (N\u2009=\u2009144', 'smokers', 'Participants completed the Adverse Childhood Experiences Questionnaire at screening']","['oxytocin', 'treatment assignment (placebo vs. oxytocin', 'neuropeptide oxytocin', 'intranasal oxytocin or placebo', 'oxytocin administration']","['sex (male vs. female), ACE (0-10 total score), pre-medication cortisol levels, and minutes since medication administration', 'cortisol response', 'ACE scores', 'Cortisol levels', 'ACE scores and cortisol reactivity indicated higher ACE scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4284014', 'cui_str': 'Adverse Childhood Experience questionnaire'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4296616', 'cui_str': 'Adverse Childhood Experiences'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0291417,"For males, higher ACE scores were associated with heightened cortisol response, an effect that was attenuated by oxytocin.","[{'ForeName': 'Caitlyn O', 'Initials': 'CO', 'LastName': 'Hood', 'Affiliation': 'Department of Psychology, College of Arts & Sciences, University of Kentucky, United States. Electronic address: caitlyn.hood@uky.edu.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Tomko', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Nathaniel L', 'Initials': 'NL', 'LastName': 'Baker', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Breanna M', 'Initials': 'BM', 'LastName': 'Tuck', 'Affiliation': 'Steve Hicks School of Social Work, University of Texas at Austin, United States.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Ralph H. Johnson VA Medical Center, United States.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Saladin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States; Hollings Cancer Center, Medical University of South Carolina, Charleston, SC, United States; Department of Health Sciences and Research, College of Health Professions, Medical University of South Carolina, Charleston, SC, United States.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'McClure', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, United States.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104752']
1521,32643327,Effects of an electric toothbrush combined with 3-color light-emitting diodes on antiplaque and bleeding control: a randomized controlled study.,"PURPOSE


This randomized controlled study aimed to evaluate the effects of an electric toothbrush with 3 colors of light-emitting diodes (LEDs) on antiplaque and bleeding control.
METHODS


This randomized, placebo-controlled, double-blinded, parallel-group clinical trial included 50 healthy adults with gingivitis, who were randomly assigned to 2 groups. The experimental group used electric toothbrushes with 3 colors of LEDs and the control group used the same electric toothbrush as the experimental group, but with LED sources with one-hundredth of the strength. The subjects used the electric toothbrush 3 times a day for 4 minutes each time. As clinical indices, bleeding on marginal probing (BOMP), the Löe-Silness gingival index (GI), and the Turesky-Quigley-Hein plaque index (QHI) were assessed at baseline, at 3 weeks, and at 6 weeks.
RESULTS


There were significant decreases in all clinical indices (BOMP, GI, QHI) in both the experimental and control groups compared to baseline at 3 weeks and at 6 weeks. In a comparison between the experimental and control groups, no statistically significant differences were observed for any clinical indices at 3 weeks ( P >0.05). However, at 6 weeks, statistically significant differences were observed between the experimental and control groups in BOMP and GI, which are indicators of gingival inflammation ( P <0.05).
CONCLUSIONS


This study demonstrated that an electric toothbrush combined with 3-color LEDs reduced gingival bleeding and inflammation after 6 weeks.",2020,"In a comparison between the experimental and control groups, no statistically significant differences were observed for any clinical indices at 3 weeks ( P >0.05).",['50 healthy adults with gingivitis'],"['electric toothbrush with 3 colors of light-emitting diodes (LEDs', 'electric toothbrushes with 3 colors of LEDs and the control group used the same electric toothbrush', 'electric toothbrush combined with 3-color LEDs', 'electric toothbrush combined with 3-color light-emitting diodes', 'placebo']","['gingival bleeding and inflammation', 'gingival inflammation', 'bleeding on marginal probing (BOMP), the Löe-Silness gingival index (GI), and the Turesky-Quigley-Hein plaque index (QHI', 'BOMP and GI', 'clinical indices (BOMP, GI, QHI', 'antiplaque and bleeding control']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}]",50.0,0.0547114,"In a comparison between the experimental and control groups, no statistically significant differences were observed for any clinical indices at 3 weeks ( P >0.05).","[{'ForeName': 'Chakyoung', 'Initials': 'C', 'LastName': 'Kwon', 'Affiliation': 'Department of Periodontology, Kyungpook National University School of Dentistry, Daegu, Korea.'}, {'ForeName': 'Jae Mok', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontology, Kyungpook National University School of Dentistry, Daegu, Korea.'}, {'ForeName': 'Jo Young', 'Initials': 'JY', 'LastName': 'Suh', 'Affiliation': 'Department of Periodontology, Kyungpook National University School of Dentistry, Daegu, Korea.'}, {'ForeName': 'Seung Jun', 'Initials': 'SJ', 'LastName': 'Seo', 'Affiliation': 'Department of Periodontology, Kyungpook National University School of Dentistry, Daegu, Korea.'}, {'ForeName': 'Youngkyun', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Department of Biochemistry, Kyungpook National University School of Dentistry, Daegu, Korea.'}, {'ForeName': 'Yong Gun', 'Initials': 'YG', 'LastName': 'Kim', 'Affiliation': 'Department of Periodontology, Kyungpook National University School of Dentistry, Daegu, Korea. periokyg@knu.ac.kr.'}]",Journal of periodontal & implant science,['10.5051/jpis.2001800090']
1522,32648393,[Effect of long-snake moxibustion on nonspecific low back pain with symptom of cold and dampness].,"OBJECTIVE


To compare the clinical therapeutic effect of long-snake moxibustion and ginger-partitioned moxibustion at  ashi  point on nonspecific low back pain (NLBP) with symptom of cold and dampness.
METHODS


A total of 120 patients were randomized into a long-snake moxibustion group, an ashi point group and a waiting for treatment group, 40 cases in each one. Ginger-partitioned moxibustion was applied from Dazhui (GV 14) to Yaoshu (GV 2) of governor vessel in the long-snake moxibustion group, and was applied at  ashi  point of affected area in the ashi point group, 40 min each time, once every other day and totally 8 times were required. No intervention was adopted in the waiting for treatment group, and after the trial, long-snake moxibustion was applied. Before and after treatment, the visual analogue scale (VAS) scores of rest and activity, the Oswestry disability index (ODI) score and the score of cold and dampness symptom were observed in the 3 groups.
RESULTS


Compared before treatment, the VAS scores of rest and activity, the ODI scores and the scores of cold and dampness symptom after treatment were decreased in the long-snake moxibustion group and the ashi point group ( P <0.05). After treatment, the variations of the above indexes in the long-snake moxibustion group and the ashi point group were larger than those in the waiting for treatment group ( P <0.05), and the variations of the above indexes in the long-snake moxibustion group were larger than those in the ashi point group ( P <0.05).
CONCLUSION


Long-snake moxibustion can effectively improve the pain, dysfunction and the symptom of cold and dampness in patients with nonspecific low back pain, and the improvement is superior to the ginger-partitioned moxibustion at  ashi  point.",2020,"Compared before treatment, the VAS scores of rest and activity, the ODI scores and the scores of cold and dampness symptom after treatment were decreased in the long-snake moxibustion group and the ashi point group ( P <0.05).","['nonspecific low back pain with symptom of cold and dampness', 'patients with nonspecific low back pain', '120 patients']","['long-snake moxibustion and ginger-partitioned moxibustion', 'long-snake moxibustion', 'Ginger-partitioned moxibustion', 'Long-snake moxibustion']","['nonspecific low back pain (NLBP', 'visual analogue scale (VAS) scores of rest and activity, the Oswestry disability index (ODI) score and the score of cold and dampness symptom', 'pain, dysfunction and the symptom of cold and dampness', 'VAS scores of rest and activity, the ODI scores and the scores of cold and dampness symptom']","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0037382', 'cui_str': 'Suborder Serpentes'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0162751', 'cui_str': 'Ginger'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",120.0,0.0264507,"Compared before treatment, the VAS scores of rest and activity, the ODI scores and the scores of cold and dampness symptom after treatment were decreased in the long-snake moxibustion group and the ashi point group ( P <0.05).","[{'ForeName': 'Xiu-Wu', 'Initials': 'XW', 'LastName': 'Hu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Li-Mei', 'Initials': 'LM', 'LastName': 'Tang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Chen-Ying', 'Initials': 'CY', 'LastName': 'Deng', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Huang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Xiao-Ming', 'Initials': 'XM', 'LastName': 'Jiang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Zhu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Fen-Fen', 'Initials': 'FF', 'LastName': 'Qiu', 'Affiliation': 'Second Department of Internal Medicine, Nanchang Hongdu Hospital of TCM, Nanchang 330006, Jiangxi Province, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190615-k0004']
1523,32648394,[Herb-separated moxibustion on dysmenorrhea in ovarian endometriosis: a randomized controlled trial].,"OBJECTIVE


To observe the clinical therapeutic effect of herb-separated moxibustion on dysmenorrhea in ovarian endometriosis.
METHODS


A total of 54 patients with ovarian endometriosis dysmenorrhea were randomized into a herb-separated moxibustion group and a waiting-list group, 27 cases in each one (3 cases dropped off in the herb-separated moxibustion group, 4 cases dropped off in the waiting-list group). Herb-separated moxibustion was applied at hypogastrium and lumbosacral area for 30 min in the herb-separated moxibustion group, once a week for 3 months, and oral ibuprofen sustained-release capsule was given to relieve pain when necessary. Excepting giving ibuprofen sustained-release capsule when necessary, no more intervention was adopted in the waiting-list group. Before and after treatment and in 3 months follow-up, visual analogue scale (VAS) score, days of dysmenorrhea, total dose of oral painkiller were observed.
RESULTS


Compared before treatment, the VAS scores after tratment and in follow-up were decreased in the herb-separated moxibustion group ( P <0.05), and were less than those in the waiting-list group ( P <0.05); the days of dysmenorrhea and the total doses of oral painkiller after tratment and in follow-up were decreased in the herb-separated moxibustion group ( P <0.05), and were less than those in the waiting-list group ( P <0.05).
CONCLUSION


Herb-separated moxibustion can effectively improve dysmenorrhea symptom and shorten dysmenorrhea days in patients with ovarian endometriosis.",2020,"Compared before treatment, the VAS scores after tratment and in follow-up were decreased in the herb-separated moxibustion group ( P <0.05), and were less than those in the waiting-list group ( P <0.05); the days of dysmenorrhea and the total doses of oral painkiller after tratment and in follow-up were decreased in the herb-separated moxibustion group ( P <0.05), and were less than those in the waiting-list group ( P <0.05).
","['54 patients with ovarian endometriosis dysmenorrhea', 'patients with ovarian endometriosis', 'ovarian endometriosis']","['Herb-separated moxibustion', 'herb-separated moxibustion group and a waiting-list', 'ibuprofen', 'herb-separated moxibustion']","['visual analogue scale (VAS) score, days of dysmenorrhea, total dose of oral painkiller', 'dysmenorrhea', 'days of dysmenorrhea and the total doses of oral painkiller', 'dysmenorrhea symptom', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0156344', 'cui_str': 'Endometriosis of ovary'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}]","[{'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",54.0,0.0324037,"Compared before treatment, the VAS scores after tratment and in follow-up were decreased in the herb-separated moxibustion group ( P <0.05), and were less than those in the waiting-list group ( P <0.05); the days of dysmenorrhea and the total doses of oral painkiller after tratment and in follow-up were decreased in the herb-separated moxibustion group ( P <0.05), and were less than those in the waiting-list group ( P <0.05).
","[{'ForeName': 'Li-Fang', 'Initials': 'LF', 'LastName': 'Chen', 'Affiliation': 'Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310005, China.'}, {'ForeName': 'Xiao-Fei', 'Initials': 'XF', 'LastName': 'Jin', 'Affiliation': 'Yuhang Maternity and Children Healthcare Hospital of Hangzhou City.'}, {'ForeName': 'Bang-Wei', 'Initials': 'BW', 'LastName': 'Li', 'Affiliation': 'Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310005, China.'}, {'ForeName': 'Ming-Jie', 'Initials': 'MJ', 'LastName': 'Zhan', 'Affiliation': 'Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310005, China.'}, {'ForeName': 'Han-Tong', 'Initials': 'HT', 'LastName': 'Hu', 'Affiliation': 'Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310005, China.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190716-k0003']
1524,32648395,[Clinical observation of herb-separated moxibustion combining western medication on allergic rhinitis of kidney- yang  deficiency type and correlation with infrared thermal imagining].,"OBJECTIVE


To observe the therapeutic effect of herb-separated moxibustion combined with budesonide nasal spray (rhinocort) on moderate to severe persistent allergic rhinitis (AR) of kidney- yang  deficiency type, and to explore the correlation between nasal temperature and condition of allergic rhinitis.
METHODS


A total of 70 patients with moderate to severe persistent AR were randomized into an observation group (35 cases) and a control group (35 cases, 3 cases dropped off). Both groups were treated with rhinocort, one spray on each side of the nostril (approximately 64 μg each spray), once in the morning and once in the evening, for 4 weeks. On the basis of the above treatment, the observation group was treated with herb-separated moxibustion at Shenshu (BL 23), Feishu (BL 13), Zhiyang (GV 9), Dazhui (GV 14), 3 moxibustions per acupoint, a single treatment lasting about 30 min. This treatment was given once every other day, 3 times every week, and totally continuous 4 weeks. The changes of AR symptom visual analogue scale (VAS) scores were observed before and after treatment and at 3 months follow-up after treatment. The heat variation (temperature, range) on projection areas of the nose, lungs, large intestine and kidneys of the two groups' patients before and after treatment were detected by the infrared thermal imaging diagnostic system, and the correlation between the VAS scores and nasal temperature before and after treatment was analyzed. The clinical effects of both groups were evaluated according to the VAS score.
RESULTS


The total effective rate in the observation group after treatment was 85.7% (30/35), which was higher than 71.9% in the control group (23/32,  P <0.05). After treatment and at follow-up, the VAS scores of both groups were lower than those before treatment ( P <0.05), and the VAS score of the observation group was lower than that of the control group at follow-up ( P <0.05). After treatment, the nasal temperature, pulmonary range, large intestinal range and renal range of the observation group were all lower than those before treatment ( P <0.05), the nasal temperature and nasal range of the control group were lower than before treatment ( P <0.05), and the reduction of nasal temperature, nasal range and renal range in the observation group was greater than that of the control group ( P <0.05). Before and after treatment, there was a correlation between VAS score and nasal temperature ( P <0.05).
CONCLUSION


The herb-separated moxibustion combining western medication has a better effect and long-term effect than western medication alone for moderate to severe persistent AR, which can improve heat variation on projected areas of the nose, lung, large intestine and kidney of patients. In addition, nasal temperature can reflect the severity of the symptoms of patients with moderate to severe persistent AR, or it can be used as a secondary indicator to evaluate condition of AR.",2020,"After treatment and at follow-up, the VAS scores of both groups were lower than those before treatment ( P <0.05), and the VAS score of the observation group was lower than that of the control group at follow-up ( P <0.05).","['70 patients with moderate to severe persistent AR', 'moderate to severe persistent allergic rhinitis (AR']","['herb-separated moxibustion combining western medication', 'herb-separated moxibustion at Shenshu (BL 23), Feishu (BL 13), Zhiyang (GV 9), Dazhui (GV 14), 3 moxibustions per acupoint', 'herb-separated moxibustion combined with budesonide nasal spray (rhinocort']","['nasal temperature, pulmonary range, large intestinal range and renal range', 'VAS score', 'total effective rate', 'changes of AR symptom visual analogue scale (VAS) scores', 'nasal temperature and nasal range', 'heat variation (temperature, range) on projection areas of the nose, lungs, large intestine and kidneys', 'VAS scores and nasal temperature', 'VAS score and nasal temperature', 'reduction of nasal temperature, nasal range and renal range', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1245189', 'cui_str': 'Budesonide Nasal Spray'}, {'cui': 'C0678163', 'cui_str': 'Rhinocort'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0021851', 'cui_str': 'Structure of large intestine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",70.0,0.0139167,"After treatment and at follow-up, the VAS scores of both groups were lower than those before treatment ( P <0.05), and the VAS score of the observation group was lower than that of the control group at follow-up ( P <0.05).","[{'ForeName': 'Yi-Fan', 'Initials': 'YF', 'LastName': 'Jia', 'Affiliation': 'Department of TCM, Peking Union Medical College Hospital, Beijing 100010, China.'}, {'ForeName': 'Ji-Ping', 'Initials': 'JP', 'LastName': 'Zhao', 'Affiliation': 'Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of CM, Beijing 100700.'}, {'ForeName': 'Zhi-Hong', 'Initials': 'ZH', 'LastName': 'Wen', 'Affiliation': 'Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of CM, Beijing 100700.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of CM, Beijing 100700.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Department of Acupuncture and Moxibustion, Dongzhimen Hospital, Beijing University of CM, Beijing 100700.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190613-0001']
1525,32648396,[Effect of electro-nape-acupuncture on hearing in patients with refractory flat descending idiopathic sudden sensorineural hearing loss].,"OBJECTIVE


To compare the therapeutic effect of electro-nape-acupuncture (ENA) combined with hyperbaric oxygen therapy (HBOT) and single HBOT on refractory flat descending idiopathic sudden sensorineural hearing loss (ISSNHL).
METHODS


A total of 78 patients were randomized into an ENA combined with HBOT (ENA+HBOT) group and a HBOT group, 39 cases in each one. Patients in both groups were treated with oral extract of ginkgo biloba leaves and mecobalamin tablets. On the basis of the conventional medication treatment, HBOT was adopt in the HBOT group. On the basis of the treatment in the HBOT group, electro-nape-acupuncture was applied at Fengchi (GB 20), Gongxue (Extra), Zhongzhu (TE 3), Waiguan (TE 5) and Yifeng (TE 17), Tinggong (SI 19), Tinghui (GB 2) and the vertigo-auditory area of affected side in the ENA+HBOT group. Pulse acupuncture instrument was connected at Fengchi (GB 20) and Gongxue (Extra) for 30 min (with continuous wave, 2 Hz in frequency), the needles were retained for another 30 min after electroaupuncture. The treatment was given once a day, 6 times a week for 4 weeks in both groups. Before the treatment and 2,4 weeks into the treatment, the average auditory threshold, the scores of tinnitus handicap inventory (THI) and dizziness handicap inventory (DHI) were observed, and the therapeutic effect was evaluated in both groups.
RESULTS


Compared before treatment, the average auditory threshold, the scores of THI and DHI of 2,4 weeks into the treatment were decreased in both groups ( P <0.000 1). Compared with the HBOT group, the average auditory threshold, the scores of THI and DHI of 4 weeks into the treatment were lower in the ENA+HBOT group ( P <0.000 1). The total effective rate was 69.2% (27/39) in the ENA+HBOT group and 51.3% (20/39) in the HBOT group, there was no statistical difference ( P >0.05).
CONCLUSION


Electro-nape- acupuncture can improve the mean auditory threshold and the symptoms of tinnitus and dizziness in patients with refractory flat descending idiopathic sudden sensorineural hearing loss.",2020,"Compared with the HBOT group, the average auditory threshold, the scores of THI and DHI of 4 weeks into the treatment were lower in the ENA+HBOT group ( P <0.000 1).","['patients with refractory flat descending idiopathic sudden sensorineural hearing loss', '78 patients']","['oral extract of ginkgo biloba leaves and mecobalamin tablets', 'Electro-nape- acupuncture', 'electro-nape-acupuncture', 'HBOT', 'electro-nape-acupuncture (ENA) combined with hyperbaric oxygen therapy (HBOT) and single HBOT', 'ENA combined with HBOT (ENA+HBOT']","['total effective rate', 'average auditory threshold, the scores of tinnitus handicap inventory (THI) and dizziness handicap inventory (DHI', 'mean auditory threshold and the symptoms of tinnitus and dizziness', 'therapeutic effect', 'average auditory threshold, the scores of THI and DHI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0872895', 'cui_str': 'Ginkgo Biloba Leaf Extract'}, {'cui': 'C0065844', 'cui_str': 'mecobalamin'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0581758', 'cui_str': 'Cervical region back structure'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004312', 'cui_str': 'Auditory Threshold'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",78.0,0.0201607,"Compared with the HBOT group, the average auditory threshold, the scores of THI and DHI of 4 weeks into the treatment were lower in the ENA+HBOT group ( P <0.000 1).","[{'ForeName': 'Guo-Bin', 'Initials': 'GB', 'LastName': 'Sheng', 'Affiliation': 'First Ward of Acupuncture and Moxibustion Department, Second Affiliated Hospital of Heilongjiang University of CM, Harbin 150006, China; College of Acupuncture-Moxibustion and Tuina, Heilongjiang University of CM, Harbin 150036.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'First Ward of Acupuncture and Moxibustion Department, Second Affiliated Hospital of Heilongjiang University of CM, Harbin 150006, China.'}, {'ForeName': 'Hui-Ling', 'Initials': 'HL', 'LastName': 'Li', 'Affiliation': 'First Ward of Acupuncture and Moxibustion Department, Second Affiliated Hospital of Heilongjiang University of CM, Harbin 150006, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Bao', 'Affiliation': 'First Ward of Acupuncture and Moxibustion Department, Second Affiliated Hospital of Heilongjiang University of CM, Harbin 150006, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'First Ward of Acupuncture and Moxibustion Department, Second Affiliated Hospital of Heilongjiang University of CM, Harbin 150006, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'First Ward of Acupuncture and Moxibustion Department, Second Affiliated Hospital of Heilongjiang University of CM, Harbin 150006, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Otolaryngology, First Affiliated Hospital of Heilongjiang University of CM, Harbin 150036; College of Clinical Medicine, Heilongjiang University of CM, Harbin 150036.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190614-k0002']
1526,32648985,"Comparison of cernitin pollen extract vs tadalafil therapy for refractory chronic prostatitis/chronic pelvic pain syndrome: A randomized, prospective study.","AIMS


To compare the efficacy of cernitin pollen extract (cernitin) or tadalafil for treating persistent chronic pelvic pain despite α1-blocker monotherapy in men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and lower urinary tract symptoms (LUTS).
METHODS


A total of 100 patients with refractory CP/CPPS despite ongoing α1-blocker monotherapy were randomized to receive add-on therapy with either cernitin (4 capsules/day) or tadalafil (5 mg/d) for 12 weeks. At week 12, changes from baseline in the patients' CP/CPPS, LUTS, and voiding function, as assessed using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), the International Prostate Symptom Score (IPSS), and uroflowmetry, respectively, were compared between the groups.
RESULTS


The final analysis included 42 and 45 patients in the cernitin and tadalafil groups, respectively. Although the NIH-CPSI total, NIH-CPSI pain sub-score, and NIH-CPSI quality of life sub-score significantly improved in both groups, the cernitin (vs tadalafil) group showed significantly greater improvements in the NIH-CPSI total score (-6.8 vs -4.6; P = .02) and NIH-CPSI pain sub-score (-4.1 vs -1.5; P < .001). Half (50%) of the patients in the cernitin group showed a reduction greater than 50% in their NIH-CPSI pain sub-score; in the tadalafil group, only four patients (8.9%) showed ≥50% improvement (P < .001). In contrast, the improvement in LUTS was significantly superior in the tadalafil group.
CONCLUSION


Both cernitin and tadalafil significantly ameliorated chronic pelvic pain in patients with refractory CP/CPPS. The add-on of cernitin was more effective than tadalafil for pelvic pain and discomfort.",2020,"At week 12, changes from baseline in the patients' CP/CPPS, LUTS, and voiding function, as assessed using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), the International Prostate Symptom Score (IPSS), and uroflowmetry, respectively, were compared between the groups.
","['patients with refractory CP/CPPS', '100 patients with refractory CP/CPPS despite ongoing α1-blocker monotherapy', 'refractory chronic prostatitis/chronic pelvic pain syndrome', 'men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) and lower urinary tract symptoms (LUTS']","['cernitin (4 capsules/day) or tadalafil', 'tadalafil', 'cernitin pollen extract (cernitin) or tadalafil', 'cernitin and tadalafil', 'cernitin pollen extract vs tadalafil therapy']","['CP/CPPS, LUTS, and voiding function, as assessed using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), the International Prostate Symptom Score (IPSS), and uroflowmetry', 'NIH-CPSI pain sub-score ', 'NIH-CPSI total score', 'NIH-CPSI total, NIH-CPSI pain sub-score, and NIH-CPSI quality of life sub-score', 'chronic pelvic pain', 'LUTS', 'pelvic pain and discomfort']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis'}, {'cui': 'C1536168', 'cui_str': 'Chronic pelvic pain syndrome'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C0032385', 'cui_str': 'Pollen'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0085696', 'cui_str': 'Chronic prostatitis'}, {'cui': 'C1536168', 'cui_str': 'Chronic pelvic pain syndrome'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",100.0,0.0402854,"At week 12, changes from baseline in the patients' CP/CPPS, LUTS, and voiding function, as assessed using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), the International Prostate Symptom Score (IPSS), and uroflowmetry, respectively, were compared between the groups.
","[{'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Matsukawa', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Yushi', 'Initials': 'Y', 'LastName': 'Naito', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Funahashi', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Ishida', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Tochigi', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Momokazu', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Urology, Graduate School of Medicine, Nagoya University, Nagoya, Japan.'}]",Neurourology and urodynamics,['10.1002/nau.24454']
1527,32645771,Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass.,"OBJECTIVE


Nitric oxide (NO) plays several protective roles in ischemia/reperfusion (I/R) injury. Neonates undergoing the Norwood procedure are subject to develop I/R injury due to the immaturity of their organs and the potential need to interrupt or decrease systemic flow during surgery. We hypothesized that NO administration during cardiopulmonary bypass (CPB) ameliorates the I/R and could help the postoperative recovery after the Norwood procedure.
METHODS


Twenty-four neonates who underwent a Norwood procedure were enrolled in a prospective randomized blinded controlled trial to receive NO (12 patients) or placebo (12 patients) into the oxygenator of the CPB circuit during the Norwood procedure. Markers of I/R injury were collected at baseline (T0), after weaning from CPB before modified ultrafiltration (T1), after modified ultrafiltration (T2), and at 12 hours (T3) and 24 hours (T4) after surgery, and they were compared between both groups, as well as other postoperative clinical variables.
RESULTS


There was no difference in age, weight, anatomical diagnosis, CPB, and aortic cross-clamp time between both groups. Troponin levels were lower in the study group at T1 (0.62 ± 58 ng/mL vs 0.87 ± 0.58 ng/mL,  P  = .31) and became significantly lower at T2 (0.36 ± 0.32 ng/mL vs 0.97 ± 0.48 ng/mL,  P  = .009).There were no significant differences between both groups for all other markers. Despite a lower troponin level, there was no difference in inotropic scores or ventricular function between both groups. Time to start diuresis, time to sternal closure and extubation, and intensive care unit and hospital stay were not different between both groups.
CONCLUSION


Systemic administration of NO during the Norwood procedure has myocardial protective effects (lower Troponin levels) but we observed no effect on postoperative recovery. Larger sample size may be needed to show clinical differences.",2020,"There was no difference in age, weight, anatomical diagnosis, CPB, and aortic cross-clamp time between both groups.",['Twenty-four neonates who underwent a Norwood procedure'],"['Nitric Oxide Administration', 'oxygenator of the CPB circuit', 'placebo']","['Troponin levels', 'Ischemia/Reperfusion Injury', 'inotropic scores or ventricular function', 'myocardial protective effects (lower Troponin levels', 'age, weight, anatomical diagnosis, CPB, and aortic cross-clamp time', 'Time to start diuresis, time to sternal closure and extubation, and intensive care unit and hospital stay']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C2242650', 'cui_str': 'Norwood procedure'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030067', 'cui_str': 'Oxygenator'}, {'cui': 'C0018830', 'cui_str': 'Cardiopulmonary bypass circuit'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0012797', 'cui_str': 'Diuresis'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",24.0,0.147463,"There was no difference in age, weight, anatomical diagnosis, CPB, and aortic cross-clamp time between both groups.","[{'ForeName': 'Chawki', 'Initials': 'C', 'LastName': 'Elzein', 'Affiliation': ""Division of Pediatric Cardiothoracic Surgery, Advocate Children's Hospital Heart Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Urbas', 'Affiliation': ""Advocate Children's Hospital Heart Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Hughes', 'Affiliation': ""Advocate Center for Pediatric Research, Advocate Children's Hospital Heart Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Patient-Centered Outcomes Research, Advocate Center for Pediatric Research, Research Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Lefaiver', 'Affiliation': ""Advocate Center for Pediatric Research, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Ilbawi', 'Affiliation': ""Division of Pediatric Cardiothoracic Surgery, Advocate Children's Hospital Heart Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Vricella', 'Affiliation': ""Division of Pediatric Cardiothoracic Surgery, Advocate Children's Hospital Heart Institute, Advocate Children's Hospital, Oak Lawn, IL, USA.""}]",World journal for pediatric & congenital heart surgery,['10.1177/2150135120911034']
1528,32651634,Intermittent versus continuous enteral nutrition attenuates increases in insulin and leptin during short-term bed rest.,"PURPOSE


To compare endocrine responses to intermittent vs continuous enteral nutrition provision during short-term bed rest.
METHODS


Twenty healthy men underwent 7 days of bed rest, during which they were randomized to receive enteral nutrition (47%E as carbohydrate, 34%E as fat, 16%E as protein and 3%E as fibre) in a continuous (CONTINUOUS; n = 10; 24 h day -1  at a constant rate) or intermittent (INTERMITTENT; n = 10; as 4 meals per day separated by 5 h) pattern. Daily plasma samples were taken every morning to assess metabolite/hormone concentrations.
RESULTS


During bed rest, plasma leptin concentrations were elevated to a lesser extent with INTERMITTENT vs CONTINUOUS (iAUC: 0.42 ± 0.38 vs 0.95 ± 0.48 nmol L -1 , respectively; P = 0.014) as were insulin concentrations (interaction effect, P < 0.001) which reached a peak of 369 ± 225 pmol L -1  in CONTINUOUS, compared to 94 ± 38 pmol L -1  in INTERMITTENT (P = 0.001). Changes in glucose infusion rate were positively correlated with changes in fasting plasma GLP-1 concentrations (r = 0.44, P = 0.049).
CONCLUSION


Intermittent enteral nutrition attenuates the progressive rise in plasma leptin and insulinemia seen with continuous feeding during bed rest, suggesting that continuous feeding increases insulin requirements to maintain euglycemia. This raises the possibility that hepatic insulin sensitivity is impaired to a greater extent with continuous versus intermittent feeding during bed rest. To attenuate endocrine and metabolic changes with enteral feeding, an intermittent feeding strategy may, therefore, be preferable to continuous provision of nutrition. This trial was registered on clinicaltrials.gov as NCT02521025.",2020,"During bed rest, plasma leptin concentrations were elevated to a lesser extent with INTERMITTENT vs CONTINUOUS (iAUC: 0.42 ± 0.38 vs 0.95 ± 0.48 nmol L -1 , respectively; P = 0.014) as were insulin concentrations (interaction effect, P < 0.001) which reached a peak of 369 ± 225 ","['Twenty healthy men underwent 7\xa0days of bed rest, during which they were randomized to receive']","['enteral nutrition (47%E as carbohydrate, 34%E as fat, 16%E as protein and 3%E as fibre', 'continuous enteral nutrition']","['Changes in glucose infusion rate', 'insulin concentrations (interaction effect', 'insulin and leptin', 'fasting plasma GLP-1 concentrations', 'plasma leptin concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}]","[{'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]",20.0,0.0678729,"During bed rest, plasma leptin concentrations were elevated to a lesser extent with INTERMITTENT vs CONTINUOUS (iAUC: 0.42 ± 0.38 vs 0.95 ± 0.48 nmol L -1 , respectively; P = 0.014) as were insulin concentrations (interaction effect, P < 0.001) which reached a peak of 369 ± 225 ","[{'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, UK. J.T.Gonzalez@bath.ac.uk.'}, {'ForeName': 'Marlou L', 'Initials': 'ML', 'LastName': 'Dirks', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Holwerda', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.'}, {'ForeName': 'Imre W K', 'Initials': 'IWK', 'LastName': 'Kouw', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.'}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'van Loon', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+ (MUMC+), Maastricht, The Netherlands.'}]",European journal of applied physiology,['10.1007/s00421-020-04431-4']
1529,32650033,Effect of clinical inertia and trial participation in younger and older adults with diabetes having comorbidities and progressive complications.,"AIM


Clinical inertia is a multifactorial phenomenon, with contributing factors from people with diabetes and their healthcare team. It is widely cited that clinical inertia is minimised by participation in clinical trials. We assessed whether trial participation per se improves metabolic parameters in people with diabetes, or a specific focus on glycaemia is required.
METHODS


We compared improvement in glycaemic control in a pooled set of people assigned to the ""placebo"" arm from 25 glycaemia-focused trials with a pooled group of people with diabetes allocated to sham or non-pharmacological intervention for the treatment of diabetic retinal disease. Mean change in HbA1c (ANCOVA) was evaluated.
RESULTS


The overall placebo effect in studies focused on glucose control (N = 3081) was comparable between strata groups with and without complications. Adjusted least square mean change in HbA1c at 24 weeks was between -0.23% (-2.50 mmol/mol) and -0.32% (-3.50 mmol/mol). In studies focused on retinal disease (N = 288), the change from baseline in HbA1c was +0.10% (1.10 mmol/mol) and fasting plasma glucose was +0.50 mmol/L showing no improvement in metabolic parameters at 12 months.
CONCLUSIONS


Clinical trial participation alone does not seem to improve metabolic parameters in people living with diabetes. The benefits observed in glycaemia-focused studies were independent of age and comorbidities.",2020,The overall placebo effect in studies focused on glucose control (N=3081) was comparable between strata groups with and without complications.,"['people with diabetes and their healthcare team', 'people with diabetes', 'younger and older adults with diabetes having comorbidities and progressive complications', 'people living with diabetes']","['sham or non-pharmacological intervention', 'placebo']","['metabolic parameters', 'fasting plasma glucose', 'Mean change in HbA1c (ANCOVA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086390', 'cui_str': 'Health Care Team'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.202893,The overall placebo effect in studies focused on glucose control (N=3081) was comparable between strata groups with and without complications.,"[{'ForeName': 'William David', 'Initials': 'WD', 'LastName': 'Strain', 'Affiliation': 'University of Exeter Medical School, Exeter, United Kingdom; Academic Department of Healthcare for the Elderly, Royal Devon & Exeter NHS Foundation Trust, Exeter, United Kingdom. Electronic address: d.strain@exeter.ac.uk.'}, {'ForeName': 'Päivi Maria', 'Initials': 'PM', 'LastName': 'Paldánius', 'Affiliation': ""Children's Hospital, Helsinki University Hospital, Helsinki, Finland; Program for Clinical and Molecular Metabolism, Helsinki University, Helsinki, Finland.""}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108310']
1530,32675595,HIPEC in advanced epithelial ovarian cancer: why is there controversy?,"PURPOSE OF REVIEW


The randomized OVHIPEC study provided further evidence that adding heated intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery significantly improved recurrence-free and overall survival in stage III epithelial ovarian cancer (EOC) patients, who were ineligible for primary cytoreductive surgery due to extensive intraperitoneal disease. Because opinions have been divided as to whether HIPEC is now a new standard of care for advanced EOC, the pros and cons of this approach are examined. A comparison with the ongoing discussion about the role of intraperitoneal chemotherapy is made.
RECENT FINDINGS


For both techniques, experience is crucial and a learning curve essential. Compared with intraperitoneal chemotherapy, intraoperative application of HIPEC provides superior distribution through the peritoneal cavity. HIPEC, as given in OVHIPEC, did not significantly increase adverse events, had no negative effect on quality of life and was cost-effective.
SUMMARY


Despite the ongoing debate about HIPEC, an important first step in attempting to demonstrate the efficacy of HIPEC in the first-line setting has been made with OVHIPEC. Critics have been of value to optimize future trials with HIPEC in patients with EOC.",2020,"HIPEC, as given in OVHIPEC, did not significantly increase adverse events, had no negative effect on quality of life and was cost-effective.
","['advanced epithelial ovarian cancer', 'patients with EOC', 'stage III epithelial ovarian cancer (EOC) patients, who were ineligible for primary cytoreductive surgery due to extensive intraperitoneal disease']","['intraperitoneal chemotherapy, intraoperative application of HIPEC', 'HIPEC', 'heated intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery', 'intraperitoneal chemotherapy']","['quality of life and was cost-effective', 'recurrence-free and overall survival', 'adverse events']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0461488,"HIPEC, as given in OVHIPEC, did not significantly increase adverse events, had no negative effect on quality of life and was cost-effective.
","[{'ForeName': 'Jan B', 'Initials': 'JB', 'LastName': 'Vermorken', 'Affiliation': 'Department of Medical Oncology.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'van Dam', 'Affiliation': 'Department of Gynecologic Oncology, Antwerp University Hospital, Edegem.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Brand', 'Affiliation': 'Department of Gynecological Oncology, Westmead Hospital.'}]",Current opinion in oncology,['10.1097/CCO.0000000000000659']
1531,32676897,Classifying the diagnosis of study participants in clinical trials: a structured and efficient approach.,"BACKGROUND


A challenge in imaging research is a diagnostic classification of study participants. We hypothesised that a structured approach would be efficient and that classification by medical students, residents, and an expert panel whenever necessary would be as valid as classification of all patients by experts.
METHODS


OPTIMACT is a randomised trial designed to evaluate the effectiveness of replacing chest x-ray for ultra-low-dose chest computed tomography (CT) at the emergency department. We developed a handbook with diagnostic guidelines and randomly selected 240 cases from 2,418 participants enrolled in OPTIMACT. Each case was independently classified by two medical students and, if they disagreed, by the students and a resident in a consensus meeting. Cases without consensus and cases classified as complex were assessed by a panel of medical specialists. To evaluate the validity, 60 randomly selected cases not referred to the panel by the students and the residents were reassessed by the specialists.
RESULTS


Overall, the students and, if necessary, residents were able to assign a diagnosis in 183 of the 240 cases (76% concordance; 95% confidence interval [CI] 71-82%). We observed agreement between students and residents versus medical specialists in 50/60 cases (83% concordance; 95% CI 74-93%).
CONCLUSIONS


A structured approach in which study participants are assigned diagnostic labels by assessors with increasing levels of medical experience was an efficient and valid classification method, limiting the workload for medical specialists. We presented a viable option for classifying study participants in large-scale imaging trials (Netherlands National Trial Register number NTR6163).",2020,"We observed agreement between students and residents versus medical specialists in 50/60 cases (83% concordance; 95% CI 74-93%).
","['2,418 participants enrolled in OPTIMACT', '60 randomly selected cases not referred to the panel by the students and the residents were reassessed by the specialists']",['replacing chest x-ray for ultra-low-dose chest computed tomography (CT'],[],"[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C4075962', 'cui_str': 'Low dose computed tomography of thorax'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",[],60.0,0.0447482,"We observed agreement between students and residents versus medical specialists in 50/60 cases (83% concordance; 95% CI 74-93%).
","[{'ForeName': 'Tjitske S R', 'Initials': 'TSR', 'LastName': 'van Engelen', 'Affiliation': 'Department of Internal Medicine, Center for Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Room: T1-0-240, Amsterdam, The Netherlands. t.s.vanengelen@amsterdamumc.nl.'}, {'ForeName': 'Maadrika M N P', 'Initials': 'MMNP', 'LastName': 'Kanglie', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Inge A H', 'Initials': 'IAH', 'LastName': 'van den Berk', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Merel L J', 'Initials': 'MLJ', 'LastName': 'Bouwman', 'Affiliation': 'Department of Internal Medicine, Center for Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Room: T1-0-240, Amsterdam, The Netherlands.'}, {'ForeName': 'Hind J M', 'Initials': 'HJM', 'LastName': 'Suhooli', 'Affiliation': 'Department of Internal Medicine, Center for Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Room: T1-0-240, Amsterdam, The Netherlands.'}, {'ForeName': 'Sascha L', 'Initials': 'SL', 'LastName': 'Heckert', 'Affiliation': 'Department of Internal Medicine, Center for Experimental and Molecular Medicine, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Room: T1-0-240, Amsterdam, The Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Stoker', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Patrick M M', 'Initials': 'PMM', 'LastName': 'Bossuyt', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': 'Jan M', 'Initials': 'JM', 'LastName': 'Prins', 'Affiliation': 'Department of Internal Medicine, Division of Infectious Diseases, Amsterdam UMC, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European radiology experimental,['10.1186/s41747-020-00169-y']
1532,32676959,"Novel Use of Extrapleural Autologous Blood Injection in CT-Guided Percutaneous Lung Biopsy and its Comparison to Intraparenchymal Autologous Blood Patch Injection: A Single-Center, Prospective, Randomized, and Controlled Clinical Trial.","PURPOSE


To evaluate the rate of iatrogenic pneumothorax and the need for intervention with extrapleural autologous blood injection (EPABI) along with intraparenchymal autologous blood patch injection (IABPI) or IABPI-only in CT-guided percutaneous lung biopsy.
MATERIALS AND METHODS


One hundred and thirty-nine participants were referred for CT-guided percutaneous lung biopsy, and 81 were randomized into study (EPABI + IABPI, n = 40) and control (IABPI-only, n = 41) groups. In the study group, ~5 ml of autologous blood was injected into the extrapleural space before passing through the parietal and visceral pleura. The primary outcome was the incidence of pneumothorax in two cohorts within 2 weeks after the procedure.
RESULTS


In the per-protocol population, pneumothorax rates were 5.9% and 25.7% in the study and control groups, respectively. The difference between the two groups was -19.8% (95% CI: -36.3%, 3.32%) (p = 0.025). On the other hand, in the population with no intraprocedural deviations, pneumothorax rates were 3.2% and 17.2% in the study and control groups, respectively. The difference between the two groups was -14.0% (95% CI: -29.1%, 1.07%) (p = 0.083). In the control group, 3.45% of the cases required aspiration, while no intervention was required in the study group.
CONCLUSION


The EPABI application along with IABPI is a promising method to decrease the incidence of pneumothorax following CT-guided percutaneous lung biopsy.",2020,"In the control group, 3.45% of the cases required aspiration, while no intervention was required in the study group.
","['One hundred and thirty-nine participants were referred for CT-guided percutaneous lung biopsy, and 81']","['Extrapleural Autologous Blood Injection', 'Intraparenchymal Autologous Blood Patch Injection', 'intraparenchymal autologous blood patch injection (IABPI) or IABPI', 'extrapleural autologous blood injection (EPABI']","['incidence of pneumothorax', 'pneumothorax rates', 'rate of iatrogenic pneumothorax']","[{'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0189485', 'cui_str': 'Biopsy of lung'}]","[{'cui': 'C0442091', 'cui_str': 'Extrapleural'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0375336', 'cui_str': 'Iatrogenic pneumothorax'}]",139.0,0.0386426,"In the control group, 3.45% of the cases required aspiration, while no intervention was required in the study group.
","[{'ForeName': 'Yaşar', 'Initials': 'Y', 'LastName': 'Türk', 'Affiliation': 'Radiology Department, Medical Faculty, Tekirdağ Namık Kemal University, Namik Kemal Mh., Kampus Cd., 59100, Suleymanpasa, Tekirdağ, Turkey. yturk@nku.edu.tr.'}, {'ForeName': 'Atakan', 'Initials': 'A', 'LastName': 'Küskün', 'Affiliation': 'Radiology Department, Kırklareli State Hospital, Yayla Mh, 39000, Kırklareli, Turkey.'}, {'ForeName': 'İsmail', 'Initials': 'İ', 'LastName': 'Devecioğlu', 'Affiliation': 'Biomedical Engineering Department, Çorlu Engineering Faculty, Tekirdağ Namık Kemal University, Silahtaraga Mh., Çorlu, Tekirdağ, Turkey.'}]",Cardiovascular and interventional radiology,['10.1007/s00270-020-02585-4']
1533,32673877,Patient Advocates for Low-Income Adults with Moderate to Severe Asthma: A Randomized Clinical Trial.,"BACKGROUND


Few interventions have targeted low-income adults with moderate to severe asthma despite their high mortality.
OBJECTIVE


To assess whether a patient advocate (PA) intervention improves asthma outcomes over usual care (UC).
METHODS


This 2-armed randomized clinical trial recruited adults with moderate to severe asthma from primary care and asthma-specialty practices serving low-income neighborhoods. Patients were randomized to 6 months of a PA intervention or UC. PAs were recent college graduates anticipating health care careers, who coached, modeled, and assisted participants with preparations for asthma-related medical visits, attended visits, and confirmed participants' understanding of provider recommendations. Participants were followed for at least a year for patient-centered asthma outcomes: asthma control (primary outcome), quality of life, prednisone requirements, emergency department visits, and hospitalizations.
RESULTS


There were 312 participants. Their mean age was 51 years (range, 19-93 years), 69% were women, 66% African American, 8% Hispanic/Latino, 62% reported hospitalization for asthma in the year before randomization, 21% had diabetes, and 61% had a body mass index of 30 or more. Asthma control improved over 12 months, more in the intervention group (-0.45 [95% CI, -0.67 to -0.21]) than in the UC group (-0.26 [95% CI, -0.53 to -0.01]), and was sustained at 24 months but with no statistical difference between groups. The 6-month rate of emergency department visits decreased in the intervention (-0.90 [95% CI, -1.56 to -0.42]) and UC (-0.42 [95% CI, -0.72 to -0.06]) groups over 12 months. The cost of the PA program was $1521 per patient. Only 64% of those assigned had a PA visit.
CONCLUSIONS


A PA may be a promising intervention to improve and sustain outcomes in this high-risk population if expanded to address factors that make keeping appointments difficult.",2020,"Asthma control improved over 12 months, more in the intervention group [-0.45(-0.67, -0.21)] than in usual care [-0.26(-0.53, -0.01)], was sustained at 24 months but with no statistical difference between groups.","['51(range:19-93), 69% female, 66% African American, 8% Hispanic/Latino', '312 participants', 'Patient Advocates for low-income adults with moderate-severe asthma', 'adults with moderate-severe asthma from primary care and asthma specialty practices serving low-income neighborhoods', ' mean age']","['Patient Advocate intervention', 'Patient Advocate Intervention or usual care']","['Asthma control', 'quality of life, prednisone requirements, emergency department visits, hospitalizations', '6-month rate of ED visits', 'hospitalization for asthma']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C1998038', 'cui_str': 'Patient advocate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1998038', 'cui_str': 'Patient advocate'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.142415,"Asthma control improved over 12 months, more in the intervention group [-0.45(-0.67, -0.21)] than in usual care [-0.26(-0.53, -0.01)], was sustained at 24 months but with no statistical difference between groups.","[{'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Apter', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa; Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa. Electronic address: andrea.apter@uphs.upenn.edu.'}, {'ForeName': 'Luzmercy', 'Initials': 'L', 'LastName': 'Perez', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Ndicu', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Localio', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Hami', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Division of Pulmonary, Allergy, & Critical Care Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Alyssa N', 'Initials': 'AN', 'LastName': 'Mullen', 'Affiliation': 'Temple Physicians, Inc, Temple University Health System, Philadelphia, Pa.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Klusaritz', 'Affiliation': 'Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Rogers', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Zuleyha', 'Initials': 'Z', 'LastName': 'Cidav', 'Affiliation': 'Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, Pa.'}, {'ForeName': 'Tyra', 'Initials': 'T', 'LastName': 'Bryant-Stephens', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pa.""}, {'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Bender', 'Affiliation': 'National Jewish Health, Denver, Colo.'}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Reisine', 'Affiliation': 'University of Connecticut Health Center, Farmington, Conn.'}, {'ForeName': 'Knashawn H', 'Initials': 'KH', 'LastName': 'Morales', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pa.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.06.058']
1534,32648019,"Correction to: Low-phytate wholegrain bread instead of high-phytate wholegrain bread in a total diet context did not improve iron status of healthy Swedish females: a 12 week, randomized, parallel-design intervention study.",ue to author error the paper was published wit.,2020,ue to author error the paper was published wit.,['healthy Swedish females'],['wholegrain bread'],[],"[{'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0006138', 'cui_str': 'Bread'}]",[],,0.0171175,ue to author error the paper was published wit.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoppe', 'Affiliation': 'Department of Gastroenterology and Hepatology, Clinical Nutrition Unit, Sahlgrenska University Hospital, Göteborg, Sweden. michael.hoppe@nutrition.gu.se.'}, {'ForeName': 'Alastair B', 'Initials': 'AB', 'LastName': 'Ross', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Göteborg, Sweden.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Svelander', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Göteborg, Sweden.'}, {'ForeName': 'Ann-Sofie', 'Initials': 'AS', 'LastName': 'Sandberg', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Göteborg, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hulthén', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy at the University of Gothenburg, Göteborg, Sweden.'}]",European journal of nutrition,['10.1007/s00394-020-02286-1']
1535,32648021,"Reply to the comments by Vorland et al. on our paper: ""low-phytate wholegrain bread instead of high-phytate wholegrain bread in a total diet context did not improve iron status of healthy Swedish females: a 12-week, randomized, parallel-design intervention study"".",,2020,,['healthy Swedish females'],[],[],"[{'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],[],,0.0128649,,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hoppe', 'Affiliation': 'Department of Gastroenterology and Hepatology, Clinical Nutrition Unit, Sahlgrenska University Hospital, Göteborg, Sweden. michael.hoppe@nutrition.gu.se.'}, {'ForeName': 'Alastair B', 'Initials': 'AB', 'LastName': 'Ross', 'Affiliation': 'Lincoln Research Centre, AgResearch, Springs Road, Lincoln, Christchurch, New Zealand.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Svelander', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Göteborg, Sweden.'}, {'ForeName': 'Ann-Sofie', 'Initials': 'AS', 'LastName': 'Sandberg', 'Affiliation': 'Department of Biology and Biological Engineering, Food and Nutrition Science, Chalmers University of Technology, Göteborg, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hulthén', 'Affiliation': 'Department of Internal Medicine and Clinical Nutrition, Sahlgrenska Academy at the University of Gothenburg, Göteborg, Sweden.'}]",European journal of nutrition,['10.1007/s00394-020-02288-z']
1536,32648397,[Effect of needle-knife as adjunctive therapy on dry eye syndrome].,"OBJECTIVE


To observe the clinical effect of needle-knife at cervical spine area as adjunctive therapy on dry eye syndrome.
METHODS


A total of 84 patients with dry eye syndrome were randomized into 3 groups, named group A, group B and group C, 28 cases in each one (1 case dropped off in the group A, 2 cases dropped off in both group B and C). In the group A, needle-knife was applied at the margo inferior of external occipital protuberance, the range of 4 cm bilateral to external occipital protuberance, the spinous process of C 2 , the range of 3 cm bilateral to 2 cm above C 2  spinous process, the range of 2 cm bilateral to C 2 , C 4 , C 6  spinous process for once a week; acupuncture was applied at Jingming (BL 1), Cuanzhu (BL 2), Zusanli (ST 36), Sanyinjiao (SP 6), Taixi (KI 3), Yanglao (SI 6), Ganshu (BL 18), Shenshu (BL 23), etc. for once a day, 6 times a week; sodium hyaluronate eye drop was given one drop once, 5-6 times a day. Treatment of acupuncture and sodium hyaluronate eye drop was given in the group B, sodium hyaluronate eye drop was given in the group C, the acupoints selection and the manipulation of acupuncture, the dosage of sodium hyaluronate eye drop were the same as the group A. One week was as one course and 3 courses were required in the 3 groups. SchirmerⅠtest (SⅠT), break-up time (BUT), scores of corneal fluorescein staining (CFS) and eye symptom before and after treatment were observed, the clinical effect was evaluated in the 3 groups.
RESULTS


SⅠT was increased, BUT was prolonged, scores of CFS and eye symptom were reduced after treatment in the group A and group B ( P <0.01); scores of CFS and eye symptom were reduced after treatment in the group C ( P <0.01). The variations of SⅠT, BUT and the scores of CFS and eye symptom in the group A were greater than those in the group B and the group C ( P <0.01); the variations of above indexes in the group B were greater than those in the group C ( P <0.05,  P <0.01). The total effective rate was 94.4% (51/54) in the group A, which was superior to 78.8% (41/52) in the group B and 48.1% (25/52) in the group C ( P <0.01), and the total effective rate in the group B was superior to the group C ( P <0.01).
CONCLUSION


Needle-knife at cervical spine area as adjunctive therapy can relieve the clinical symptoms and improve the function of lacrimal gland in patients with dry eye syndrome.",2020,"RESULTS


SⅠT was increased, BUT was prolonged, scores of CFS and eye symptom were reduced after treatment in the group A and group B ( P <0.01); scores of CFS and eye symptom were reduced after treatment in the group C ( P <0.01).","['patients with dry eye syndrome', 'dry eye syndrome', '84 patients with dry eye syndrome']","['acupuncture', 'needle-knife', 'acupuncture and sodium hyaluronate eye', 'Needle-knife']","['total effective rate', 'scores of CFS and eye symptom', 'BUT), scores of corneal fluorescein staining (CFS) and eye symptom', 'SchirmerⅠtest (SⅠT), break-up time ', 'variations of SⅠT, BUT and the scores of CFS and eye symptom', 'clinical effect']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0181464', 'cui_str': 'Needle knife'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0586406', 'cui_str': 'Eye symptom'}, {'cui': 'C0060520', 'cui_str': 'Fluorescein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",84.0,0.0191821,"RESULTS


SⅠT was increased, BUT was prolonged, scores of CFS and eye symptom were reduced after treatment in the group A and group B ( P <0.01); scores of CFS and eye symptom were reduced after treatment in the group C ( P <0.01).","[{'ForeName': 'Jian-Wei', 'Initials': 'JW', 'LastName': 'Zhang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Weifang Traditional Chinese Hospital, Weifang 261041, Shandong Province, China.'}, {'ForeName': 'Nai-Gang', 'Initials': 'NG', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, China-Japan Friendship Hospital.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190706-0001']
1537,32648398,[Effect of  Cangguitanxue  acupuncture combined with suspension exercise therapy on chronic low back pain].,"OBJECTIVE


To observe the effect of  Cangguitanxue  acupuncture combined with suspension exercise therapy on the clinical symptoms, lumbar proprioception and trunk isokinetic muscle strength in patients with chronic low back pain.
METHODS


A total of 100 patients with chronic low back pain were randomly divided into an observation group and a control group, 50 cases in each group. The patients in the control group were treated with suspension exercise therapy, and the training exercise was selected according to the patient's exercise ability, the suspension exercise therapy was given once a day, three times a week, for totally 4 weeks. Based on the treatment of the control group, the patients in the observation group were treated with  Cangguitanxue  acupuncture at Dachangshu (BL 25), Weizhong (BL 40), Qihaishu (BL 24), Shenshu (BL 23) and  ashi  points, the acupuncture was given once a day, six times as a course of treatment, and a total of two courses of treatment were given. Before and after treatment, the scores of symptoms and signs, the pain rating index (PRI), present pain intensity (PPI) and the visual analogue scale (VAS) in the short-form of McGill pain questionnaire (SF-MPQ) in the two groups were recorded. The isokinetic feedback biomechanical test system was used to measure the lumbar proprioception and isokinetic muscle strength of the trunk, and the clinical efficacy of the two groups was evaluated.
RESULTS


The scores of symptoms and signs, PRI, PPI and VAS after treatment were lower than those before treatment in the two groups ( P <0.05), and those in the observation group were lower than those in the control group ( P <0.05). The absolute error angle (AE) of lumbar proprioceptive index in the flexion and extension positions after treatment was lower than that before treatment in the two groups ( P <0.05), and that in the observation group was lower than that in the control group ( P <0.05). After treatment, the peak torque (PT) of musculus flexor and musculus extensor as well as peak torque/body weight (PT/BW) of musculus extensor were increased in the two groups, and the flexor/extensor (F/E) was reduced ( P <0.05). The PT of musculus flexor and musculus extensor as well as PT/BW of musculus extensor in the observation group were higher than those in the control group ( P <0.05), and F/E was lower than that in the control group ( P <0.05). The total effective rate was 90.0% (45/50) in the observation group, which was higher than 76.0% (38/50) in the control group ( P <0.05).
CONCLUSION


The  Cangguitanxue  acupuncture combined with suspension exercise therapy could effectively improve the symptoms and signs of patients with chronic low back pain, enhance the lumbar proprioception and trunk isokinetic muscle strength.",2020,"The absolute error angle (AE) of lumbar proprioceptive index in the flexion and extension positions after treatment was lower than that before treatment in the two groups ( P <0.05), and that in the observation group was lower than that in the control group ( P <0.05).","['100 patients with chronic low back pain', 'patients with chronic low back pain']","['Cangguitanxue  acupuncture at Dachangshu (BL 25), Weizhong (BL 40), Qihaishu (BL 24), Shenshu (BL 23) and  ashi  points, the acupuncture', 'suspension exercise therapy', ""suspension exercise therapy, and the training exercise was selected according to the patient's exercise ability, the suspension exercise therapy"", 'Cangguitanxue  acupuncture combined with suspension exercise therapy']","['lumbar proprioception and trunk isokinetic muscle strength', 'lumbar proprioception and isokinetic muscle strength', 'scores of symptoms and signs, the pain rating index (PRI), present pain intensity (PPI) and the visual analogue scale (VAS) in the short-form of McGill pain questionnaire (SF-MPQ', 'total effective rate', 'scores of symptoms and signs, PRI, PPI and VAS', 'chronic low back pain', 'absolute error angle (AE) of lumbar proprioceptive index in the flexion and extension positions', 'peak torque (PT) of musculus flexor and musculus extensor as well as peak torque/body weight (PT/BW) of musculus extensor', 'clinical symptoms, lumbar proprioception and trunk isokinetic muscle strength']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0450634', 'cui_str': 'BL40 - popliteal crease'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",100.0,0.0184507,"The absolute error angle (AE) of lumbar proprioceptive index in the flexion and extension positions after treatment was lower than that before treatment in the two groups ( P <0.05), and that in the observation group was lower than that in the control group ( P <0.05).","[{'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Ezhou Central Hospital, Ezhou 436000, Hubei Province, China.'}, {'ForeName': 'Jun-Song', 'Initials': 'JS', 'LastName': 'Zhu', 'Affiliation': 'Department of Pain, Wuhan Puren Hospital, Wuhan 430081, Hubei Province.'}]",Zhongguo zhen jiu = Chinese acupuncture & moxibustion,['10.13703/j.0255-2930.20190624-k0004']
1538,32644883,"Noradrenergic Regulation of Cognitive Flexibility: No Effects of Stress, Transcutaneous Vagus Nerve Stimulation, and Atomoxetine on Task-switching in Humans.","Cognitive flexibility allows us to adaptively switch between different responsibilities in important domains of our daily life. Previous work has elucidated the neurochemical basis underlying the ability to switch responses to a previously nonreinforced exemplar and to switch between attentional sets. However, the role of neuromodulators in task switching, the ability to rapidly switch between two or more cognitive tasks afforded by the same stimuli, is still poorly understood. We attempted to fill this gap by manipulating norepinephrine levels using stress manipulation (Study 1a,  n  = 48; between-group design), transcutaneous vagus nerve stimulation at two different intensities (Study 1b,  n  = 48; sham-controlled between-group design), and pharmacological manipulation (Study 2,  n  = 24; double-blind crossover design), all of which increased salivary cortisol measures. Participants repeatedly switched between two cognitive tasks (classifying a digit as high/low [Task 1] or as odd/even [Task 2]), depending on the preceding cue. On each trial, a cue indicated the task to be performed. The cue-stimulus interval was varied to manipulate the time to prepare for the switch. Participants showed typical switch costs, which decreased with the time available for preparation. None of the manipulations modulated the size of the switch costs or the preparation effect, as supported by frequentist and Bayesian model comparisons. Task-switching performance reflects a complex mix of cognitive control and bottom-up dynamics of task-set representations. Our findings suggest that norepinephrine does not affect either of these aspects of cognitive flexibility.",2020,"None of the manipulations modulated the size of the switch costs or the preparation effect, as supported by frequentist and Bayesian model comparisons.",['Humans'],"['Stress, Transcutaneous Vagus Nerve Stimulation, and Atomoxetine', 'norepinephrine', 'transcutaneous vagus nerve stimulation at two different intensities (Study 1b,  n  = 48; sham-controlled between-group design), and pharmacological manipulation']","['typical switch costs', 'Noradrenergic Regulation of Cognitive Flexibility', 'salivary cortisol measures']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0076823', 'cui_str': 'atomoxetine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",48.0,0.019378,"None of the manipulations modulated the size of the switch costs or the preparation effect, as supported by frequentist and Bayesian model comparisons.","[{'ForeName': 'Klodiana-Daphne', 'Initials': 'KD', 'LastName': 'Tona', 'Affiliation': 'Leiden University.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Revers', 'Affiliation': 'Tilburg University.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Verkuil', 'Affiliation': 'Leiden University.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Nieuwenhuis', 'Affiliation': 'Leiden University.'}]",Journal of cognitive neuroscience,['10.1162/jocn_a_01603']
1539,32645765,Efficacy of Nitric Oxide Administration During Neonatal Cardiopulmonary Bypass.,"This editorial accompanies an original research article by Dr Elzein and colleagues describing findings of a randomized, placebo-controlled trial of nitric oxide administration during cardiopulmonary bypass surgery in infants undergoing the Norwood procedure.",2020,"This editorial accompanies an original research article by Dr Elzein and colleagues describing findings of a randomized, placebo-controlled trial of nitric oxide administration during cardiopulmonary bypass surgery in infants undergoing the Norwood procedure.","['infants undergoing the Norwood procedure', 'Neonatal Cardiopulmonary Bypass']","['Nitric Oxide Administration', 'nitric oxide administration', 'placebo']",[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C2242650', 'cui_str': 'Norwood procedure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.107972,"This editorial accompanies an original research article by Dr Elzein and colleagues describing findings of a randomized, placebo-controlled trial of nitric oxide administration during cardiopulmonary bypass surgery in infants undergoing the Norwood procedure.","[{'ForeName': 'Christoph P', 'Initials': 'CP', 'LastName': 'Hornik', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, USA.'}]",World journal for pediatric & congenital heart surgery,['10.1177/2150135120920625']
1540,32645767,Randomized Pilot Trial of Acute Normovolemic Hemodilution in Pediatric Cardiac Surgery Patients.,"BACKGROUND


Due to the substantial improvement in survival among pediatric patients undergoing congenital heart surgery, reducing early and long-term morbidity is becoming the major focus of care. Blood transfusion is associated with worse postoperative outcomes after cardiac surgery. Acute normovolemic hemodilution (ANH) is a blood conservation strategy that aims to reduce allogenic blood transfusion during cardiac surgery. However, there are scant data regarding its efficacy for pediatric cardiac surgery patients.
METHODS


We designed a single-center, controlled, randomized, pilot trial in patients between 6 and 36 months old undergoing pediatric heart surgery. Patients were equally assigned to undergo ANH prior to initiation of cardiopulmonary bypass or to be managed per usual care. The primary end point was the amount of blood product transfused perioperatively. Secondary end points were markers of morbidity: postoperative bleeding, hematocrit, inotropic agents use, intensive care unit, and hospital stay. The analysis was by intention-to-treat. Estimates of differences between groups are presented with 95% CIs.
RESULTS


Twelve pediatric heart surgery patients were randomized to each group, ANH and usual care. Baseline characteristics were similar between groups. Acute normovolemic hemodilution implementation did not result in a reduction in the administration of blood product transfused (difference between ANH and usual care among patients transfused = -1.4 mL [-29.4 to 26.6],  P  = .92). Secondary end points were not different between groups.
CONCLUSIONS


In this small trial of pediatric cardiac surgery patients, ANH as a strategy to reduce blood component therapy was safe; however, the study failed to show a reduction in perioperative transfusion or other postoperative outcomes.",2020,"Secondary end points were not different between groups.
","['Pediatric Cardiac Surgery Patients', 'Twelve pediatric heart surgery patients', 'pediatric cardiac surgery patients', 'pediatric patients undergoing congenital heart surgery', 'patients between 6 and 36 months old undergoing pediatric heart surgery']","['ANH prior to initiation of cardiopulmonary bypass or to be managed per usual care', 'Acute Normovolemic Hemodilution', 'Acute normovolemic hemodilution (ANH']","['markers of morbidity: postoperative bleeding, hematocrit, inotropic agents use, intensive care unit, and hospital stay', 'blood product transfused', 'amount of blood product transfused perioperatively', 'allogenic blood transfusion']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C3163775', 'cui_str': 'Acute normovolemic hemodilution'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0304509', 'cui_str': 'Inotropic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0456388', 'cui_str': 'Blood product'}, {'cui': 'C3160876', 'cui_str': 'Allogenic blood transfusion'}]",12.0,0.15526,"Secondary end points were not different between groups.
","[{'ForeName': 'Weronika M', 'Initials': 'WM', 'LastName': 'Harris', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Miriam M', 'Initials': 'MM', 'LastName': 'Treggiari', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': 'LeBlanc', 'Affiliation': 'Department of Pediatric Perfusion and ECMO Services, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Giacomuzzi', 'Affiliation': 'Department of Pediatric Perfusion and ECMO Services, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Jayme J', 'Initials': 'JJ', 'LastName': 'You', 'Affiliation': 'Department of Pediatric Perfusion and ECMO Services, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Muralidaran', 'Affiliation': 'Department of Cardiothoracic Surgery, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Shen', 'Affiliation': 'Department of Cardiothoracic Surgery, Oregon Health & Science University, Portland, OR, USA.'}]",World journal for pediatric & congenital heart surgery,['10.1177/2150135120923627']
1541,32651146,Short-term efficacy of ORS formulation and propranolol regimen in children with POTS.,"BACKGROUND


To evaluate the short-term effectiveness of reduced-osmolarity oral rehydration salt formulation (ORS) and propranolol in children diagnosed with postural orthostatic tachycardia syndrome (POTS) in head-up tilt testing (HUTT).
METHODS


Children were admitted with symptoms of orthostatic intolerance (OI) occurring in a standing position and disappearing in the supine position. Patients with heart rate increments of ≥40bpm and symptoms of OI constituted the pediatric POTS group in HUTT. A total of 70 pediatric patients with POTS were included in the study. POTS patients were divided into two groups based on whether they were prescribed reduced-osmolarity ORS and propranolol or not. The study group comprised patients on a regimen of reduced-osmolarity ORS and propranolol (n=34), while the control group comprised patients who were not prescribed any medication (n=36). The frequency of symptoms and standardized symptom scores were analyzed before and after 3 months of treatment in both groups.
RESULTS


The post-treatment frequency of syncopal attacks was significantly reduced in both groups (P<0.01 for both groups), but the post-treatment standardized symptom scores were significantly reduced in the pediatric study group compared with the control group (P<0.01).
CONCLUSION


The frequency of syncopal attacks was significantly reduced and the symptom scores for OI were improved in the study group. The improvement in OI symptom scores was better in the treatment group than in the control group. The control group symptoms persisted and caused extreme difficulty in their daily activities. In view of its clinical efficacy, we strongly advocate the use of combined treatment of reduced-osmolarity ORS and low-dose propranolol in pediatric patients with POTS.",2020,"The post-treatment frequency of syncopal attacks was significantly reduced in both groups (P<0.01 for both groups), but the post-treatment standardized symptom scores were significantly reduced in the pediatric study group compared with the control group (P<0.01).
","['Children were admitted with symptoms of orthostatic intolerance (OI) occurring in a standing position and disappearing in the supine position', 'children with POTS', 'children diagnosed with postural orthostatic tachycardia syndrome (POTS) in head-up tilt testing (HUTT', 'n=34), while the control group comprised patients who were not prescribed any medication (n=36', 'Patients with heart rate increments of ≥40bpm and symptoms of OI constituted the pediatric POTS group in HUTT', 'pediatric patients with POTS', '70 pediatric patients with POTS were included in the study']","['reduced-osmolarity oral rehydration salt formulation (ORS) and propranolol', 'propranolol', 'reduced-osmolarity ORS and propranolol', 'ORS formulation and propranolol']","['frequency of symptoms and standardized symptom scores', 'frequency of syncopal attacks', 'syncopal attacks', 'standardized symptom scores', 'symptom scores for OI', 'OI symptom scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1535893', 'cui_str': 'Orthostatic intolerance'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}, {'cui': 'C1299624', 'cui_str': 'Postural orthostatic tachycardia syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1293898', 'cui_str': 'Head up'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C3653405', 'cui_str': 'Oral rehydration salt formulations'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0436350', 'cui_str': 'Symptom frequency'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C1535893', 'cui_str': 'Orthostatic intolerance'}]",70.0,0.0281252,"The post-treatment frequency of syncopal attacks was significantly reduced in both groups (P<0.01 for both groups), but the post-treatment standardized symptom scores were significantly reduced in the pediatric study group compared with the control group (P<0.01).
","[{'ForeName': 'Yilmaz', 'Initials': 'Y', 'LastName': 'Yozgat', 'Affiliation': 'Department of Pediatric Cardiology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Hafize Otcu', 'Initials': 'HO', 'LastName': 'Temur', 'Affiliation': 'Department of Radiology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Senay', 'Initials': 'S', 'LastName': 'Coban', 'Affiliation': 'Department of Pediatric Cardiology, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'Taliha', 'Initials': 'T', 'LastName': 'Oner', 'Affiliation': ""Department of Pediatric Cardiology, Izmir Dr. Behcet Uz Children's Hospital, Izmir, Turkey.""}, {'ForeName': 'Utku', 'Initials': 'U', 'LastName': 'Karaarslan', 'Affiliation': ""Department of Pediatrics, Izmir Dr. Behcet Uz Children's Hospital, Izmir, Turkey.""}, {'ForeName': 'Can Yilmaz', 'Initials': 'CY', 'LastName': 'Yozgat', 'Affiliation': 'Faculty of Medicine, Bezmialem Vakif University, Istanbul, Turkey. Electronic address: yozgatyilmaz@gmail.com.'}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Karadeniz', 'Affiliation': ""Department of Pediatric Cardiology, Izmir Dr. Behcet Uz Children's Hospital, Izmir, Turkey.""}, {'ForeName': 'Serap Nur', 'Initials': 'SN', 'LastName': 'Ergor', 'Affiliation': 'Department of Neonatology, Bezmialem Vakif University, Istanbul, Turkey.'}, {'ForeName': 'Ufuk', 'Initials': 'U', 'LastName': 'Erenberk', 'Affiliation': 'Department of Pediatrics, Bezmialem Vakif University, Istanbul, Turkey.'}]",Archives de pediatrie : organe officiel de la Societe francaise de pediatrie,['10.1016/j.arcped.2020.06.001']
1542,32650261,Efficacy and safety of systemic tranexamic acid administration in total knee arthroplasty: A case series.,"INTRODUCTION


Total knee arthroplasty (TKA) are associated with significant postoperative blood loss. Tranexamic acid (TXA) is a potent agent with antifibrinolytic activity, that can be administered via the intravenous (IV) and/or topical (intra-articular, IA) route, which can possibly interrupt the cascade of events due to hemostatic irregularities close to the source of bleeding. However, the literature contains scarce scientific evidence related to IV only TXA usage in TKA. The current study aims to compare the outcome between patients who were administered IV TXA and a control group in terms of blood loss, transfusion rate, and incidence of deep vein thrombosis (DVT) and thromboembolism (TE).
METHODS


110 patients, who underwent TKA were placed into two groups: 1) 34 patients who received IV TXA; and 2) 76 patients in the control group. In the TXA group, patients received an IV TXA dose of 1 g, 30 min before incision. Two drains were placed.
RESULTS


Usage of IV TXA showed better results when compared to the control group in terms of mean blood transfusion (0.5 less transfusion during hospital stay), hemoglobin drop (10%). No cases of DVT or TE were noted among the two study groups.
CONCLUSION


Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA. Moreover, TXA use is safe in terms of incidence of symptomatic DVT and TE.",2020,Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA.,"['total knee arthroplasty', '110 patients, who underwent TKA were placed into two groups: 1) 34 patients who received']","['IV TXA', 'TXA', 'systemic tranexamic acid', 'Tranexamic acid (TXA', 'Total knee arthroplasty (TKA']","['mean blood transfusion', 'DVT or TE', 'Efficacy and safety', 'blood loss, transfusion rate, and incidence of deep vein thrombosis (DVT) and thromboembolism (TE']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332286', 'cui_str': 'Into'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",110.0,0.0314014,Use of IV TXA provided significantly better results compared to no TXA use with respect to all variables related to postoperative blood loss in TKA.,"[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Maalouly', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Josephmaalouly2@gmail.com.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'El Assaad', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Donna.elassaad@lau.edu.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Ayoubi', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: rami.ayoubi1@gmail.com.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Tawk', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Antoniostawk@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Mohammaddarwish2@gmail.com.'}, {'ForeName': 'Dany', 'Initials': 'D', 'LastName': 'Aouad', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Dany_aouad@hotmail.com.'}, {'ForeName': 'Georgio', 'Initials': 'G', 'LastName': 'Lati', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Georgio.lati@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Darwish', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: Mohammaddarwish2@gmail.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'El Rassi', 'Affiliation': 'Department of Orthopedic Surgery and Traumatology Saint Georges University Medical Center, Balamand University, P.O. Box 166378, Achrafieh, Beirut, 1100 2807, Lebanon. Electronic address: gselrassi@gmail.com.'}]",International journal of surgery case reports,['10.1016/j.ijscr.2020.06.077']
1543,32652462,Improving medication adherence with adjuvant aromatase inhibitor in women with breast cancer: A randomised controlled trial to evaluate the effect of short message service (SMS) reminder.,"BACKGROUND


Medication adherence is crucial for improving clinical outcomes in the treatment of patients. We evaluate the effect of short message service (SMS) reminder on medication adherence and serum hormones in patients with breast cancer on aromatase inhibitors.
METHODS


An open-label, multi-centre, prospective randomised controlled trial of SMS versus Standard Care was conducted. Medication adherence was assessed via self-report using the Simplified Medication Adherence Questionnaire at baseline, 6 month, and 1 year. Androstenedione, estradiol, and estrone were measured at baseline and 1 year. The χ 2  test and mixed effects logistic regression was performed to compare medication adherence between groups. Difference in androstenedione and estrone levels were assessed using analysis of covariance, whereas χ 2  test and logistic regression was used for estradiol. Analysis was based on intention-to-treat.
RESULTS


A total of 244 patients were randomised to receive weekly SMS reminder (n = 123) or Standard Care (n = 121) between May 2015 and December 2018. The odds of adherence was higher at 6-month in SMS (OR = 1.78, 95% CI 1.04-3.05, p = 0.034), and not significantly different at 1-year (OR = 1.15, 95% CI: 0.67-1.96 p = 0.617). Mixed effects logistic regression analysis showed higher odds of adherence in SMS over the 1-year period (OR = 2.35, 95% CI: 1.01-5.49, p = 0.048). There was no difference in serum hormone levels between groups.
CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term. Future studies could investigate the use of tailored SMS intervention according to patient preference to improve its sustainability.",2020,"CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term.","['patients with breast cancer on aromatase inhibitors', 'patients', '244 patients', 'women with breast cancer']","['short message service (SMS) reminder', 'SMS', 'adjuvant aromatase inhibitor', 'SMS intervention', 'SMS reminder (n\xa0=\xa0123) or Standard Care']","['Medication adherence', 'Androstenedione, estradiol, and estrone', 'medication adherence and serum hormones', 'odds of adherence', 'serum hormones levels', 'androstenedione and estrone levels', 'serum hormone levels', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0002860', 'cui_str': 'Androstenedione'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0014942', 'cui_str': 'Estrone'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0236379', 'cui_str': 'Estrone measurement'}]",244.0,0.22356,"CONCLUSION


SMS reminder improved medication adherence in the short-term but had no effect on serum hormones levels in the longer term.","[{'ForeName': 'Eng Hooi', 'Initials': 'EH', 'LastName': 'Tan', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-03F, 117549, Singapore.'}, {'ForeName': 'Andrea Li Ann', 'Initials': 'ALA', 'LastName': 'Wong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Chuan Chien', 'Initials': 'CC', 'LastName': 'Tan', 'Affiliation': 'Department of General Surgery, Ng Teng Fong General Hospital, 1 Jurong East Street 21, 609606, Singapore.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wong', 'Affiliation': 'Division of Oncology Pharmacy, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Sing Huang', 'Initials': 'SH', 'LastName': 'Tan', 'Affiliation': 'OncoCare Cancer Centre, 6 Napier Road, #02-17/18/19, Gleneagles Medical Centr, 258499, Singapore.'}, {'ForeName': 'Li En Yvonne', 'Initials': 'LEY', 'LastName': 'Ang', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Siew Eng', 'Initials': 'SE', 'LastName': 'Lim', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Wan Qin', 'Initials': 'WQ', 'LastName': 'Chong', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Jingshan', 'Initials': 'J', 'LastName': 'Ho', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Soo Chin', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, NUHS Tower Block Level 7, 1E Kent Ridge Road, 119228, Singapore.'}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, 12 Science Drive 2, #10-03F, 117549, Singapore; Yong Loo Lin School of Medicine, National University of Singapore and National University Health System, 1E Kent Ridge Road, 119228, Singapore. Electronic address: ephtbc@nus.edu.sg.'}]","Breast (Edinburgh, Scotland)",['10.1016/j.breast.2020.06.012']
1544,32653604,"Impact of bupivacaine injection to trocar sites on postoperative pain following laparoscopic hysterectomy: Results from a prospective, multicentre, double-blind randomized controlled trial.","OBJECTIVES


Laparoscopic surgery has numerous advantages over open surgery in view of postoperative pain. In this context, to elevate its benefits and patient satisfaction, different pain management interventions have been used so far. This study aimed to evaluate the effect of bupivacaine injection to trocar sites following laparoscopic hysterectomy for the management of postoperative pain.
STUDY DESIGN


In this study, patients were randomized into two groups (56 cases; 52 controls). A single injection of bupivacaine (0.5 %, 5 mg/mL) was introduced to trocar sites under subcutaneous tissue at a dose of 4 ml for the umbilicus and 2 ml for each 5-mm ancillary trocar site in the study group. No bupivacaine was administered to the control group. The primary aim was to measure differences in 2 -h postoperative numerical rating scale (NRS) pain scores between the two groups. The secondary aims were to evaluate differences between 1-, 4-, 6-, 24- and 48 -h postoperative NRS pain scores, surgical complications, estimated blood loss, duration of operation and analgesic consumption.
RESULTS


The number of postoperative rescue doses of analgesics was found to be lower in the study group compared to the control group (median of 2 vs. 4; p < 0.01). The 1-, 4-, 6-, 24- and 48-hour postoperative NRS pain scores were also found to be lower in the study group compared to the control group (p < 0.01 at each follow-up). The mean duration of surgery and uterus removal, as well as the estimated blood loss, were not significantly different between the two groups.
CONCLUSIONS


The present study suggests that bupivacaine injection to trocar sites is an effective and safe method for reducing pain following laparoscopic hysterectomy.",2020,The number of postoperative rescue doses of analgesics was found to be lower in the study group compared to the control group (median of 2 vs. 4; p < 0.01).,['laparoscopic hysterectomy'],"['laparoscopic hysterectomy', 'Laparoscopic surgery', 'bupivacaine injection to trocar sites', 'bupivacaine']","['48-hour postoperative NRS pain scores', '2 -h postoperative numerical rating scale (NRS) pain scores', 'mean duration of surgery and uterus removal', 'postoperative pain', 'postoperative NRS pain scores, surgical complications, estimated blood loss, duration of operation and analgesic consumption', 'estimated blood loss', 'pain', 'number of postoperative rescue doses of analgesics']","[{'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}]","[{'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C4060211', 'cui_str': 'Bupivacaine Injection [Sensorcaine]'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.144145,The number of postoperative rescue doses of analgesics was found to be lower in the study group compared to the control group (median of 2 vs. 4; p < 0.01).,"[{'ForeName': 'Ismet', 'Initials': 'I', 'LastName': 'Hortu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Ege University School of Medicine, Izmir, Turkey; Department of Stem Cell, Ege University Institute of Health Sciences, Izmir, Turkey. Electronic address: ismethortu@yahoo.com.'}, {'ForeName': 'Unal', 'Initials': 'U', 'LastName': 'Turkay', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Health Sciences Derince Education and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Terzi', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Health Sciences Derince Education and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Kale', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Health Sciences Derince Education and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Anaesthesiology, University of Health Sciences Derince Education and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Canan', 'Initials': 'C', 'LastName': 'Balcı', 'Affiliation': 'Department of Anaesthesiology, University of Health Sciences Derince Education and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Umit', 'Initials': 'U', 'LastName': 'Aydın', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Health Sciences Derince Education and Research Hospital, Kocaeli, Turkey.'}, {'ForeName': 'Antonio Simone', 'Initials': 'AS', 'LastName': 'Laganà', 'Affiliation': 'Department of Obstetrics and Gynaecology, ""Filippo Del Ponte"" Hospital, University of Insubria, Varese, Italy.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.07.007']
1545,32653606,Effects of the levonorgestrel intrauterine system on the endometrium after long-term exposure to mifepristone: Secondary outcomes of a randomized controlled trial.,"OBJECTIVE


Long-term treatment with progesterone receptor modulators (PRM) is associated with a distinct histological entity termed progesterone receptor modulator associated endometrial changes (PAEC). While accumulating evidence implies that these changes are benign and reversible after cessation of treatment, there are currently no data underpinning their development. Consequently, as a precaution, endometrial shedding is recommended after long-term PRM intake. Avoiding endometrial shedding after treatment with a PRM and prior to the start of a progestin treatment would be beneficial for women in reproductive age to avoid pregnancy and bleeding. However, the endometrial morphology with such a treatment regimen is unknown. The aim of this study was to delineate the endometrial morphology following continuous long-term treatment with the PRM mifepristone and subsequent placement of a levonorgestrel intrauterine system (LNG-IUS) without prior shedding of the endometrium.
STUDY DESIGN


This study reports the secondary outcome from a double-blinded randomized controlled trial conducted at Karolinska University Hospital, Sweden, November 2009 to January 2015. Healthy women aged 18-43 years with regular menstrual cycles were included. Eligible women were randomized to receive either 50 mg of mifepristone (n = 29) or a comparator (n = 29), every other day for two months followed by insertion of an LNG-IUS 52 mg. Endometrial biopsies were obtained at baseline and three months after placement of the device. The samples were histologically assessed. The main outcome measure of this sub-study was the endometrial morphology including presence of PAEC three months after LNG-IUS insertion.
RESULTS


Nine and eight paired biopsies from the mifepristone and comparator group, respectively, were included in the histological analysis. There were no differences in baseline characteristics between the groups and all baseline endometrial biopsies were physiological. Three months after LNG-IUS placement the endometrial morphology was still benign without PAEC in all samples treated with either mifepristone or comparator. A progestin effect on the endometrium was seen in all samples.
CONCLUSIONS


Placement of an LNG-IUS immediately following two months' treatment with the PRM mifepristone, without any prior shedding of the endometrium, may represent a feasible approach in terms of endometrial safety. However, larger studies are needed to confirm our results.",2020,Three months after LNG-IUS placement the endometrial morphology was still benign without PAEC in all samples treated with either mifepristone or comparator.,"['Karolinska University Hospital, Sweden, November 2009 to January 2015', 'Eligible women', 'Healthy women aged 18-43 years with regular menstrual cycles']","['progesterone receptor modulators (PRM', 'mifepristone', 'PRM mifepristone', 'levonorgestrel intrauterine system', 'progestin treatment', 'PRM mifepristone and subsequent placement of a levonorgestrel intrauterine system (LNG-IUS']",['Endometrial biopsies'],"[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}]","[{'cui': 'C3653463', 'cui_str': 'Progesterone receptor modulators'}, {'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}]",,0.419988,Three months after LNG-IUS placement the endometrial morphology was still benign without PAEC in all samples treated with either mifepristone or comparator.,"[{'ForeName': 'Kiriaki', 'Initials': 'K', 'LastName': 'Papaikonomou', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden. Electronic address: kiriaki.papaikonomou@ki.se.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Frisendahl', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.""}, {'ForeName': 'Alistair R W', 'Initials': 'ARW', 'LastName': 'Williams', 'Affiliation': 'Division of Pathology, The Royal Infirmary of Edinburgh, The University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.06.056']
1546,32653726,High rate of antimicrobial resistance and multiple mutations in the dihydrofolate reductase gene among Streptococcus pneumoniae isolated from HIV-infected adults in a community setting in Tanzania.,"OBJECTIVES


The aim of this study was to characterize molecular mechanisms of resistance to trimethoprim and other antibiotics in Streptococcus pneumoniae isolates from HIV-infected adults in Dar es Salaam, Tanzania.
METHODS


A total of 1877 nasopharyngeal swabs were collected and screened for pneumococcal colonization from 537 newly diagnosed individuals with HIV at four clinic visits during a 1-year follow-up from 2017-2018 as part of the randomized clinical trial CoTrimResist (ClinicalTrials.gov ID: NCT03087890).
RESULTS


A total of 76 pneumococcal isolates were obtained. Of the 70 isolates that could be serotyped, 42 (60.0%) were vaccine serotypes included in pneumococcal conjugate vaccine 23 (PCV23). The majority of isolates (73.7%; 56/76) were non-susceptible to penicillin (MICs of 0.06-2μg/mL). Isolates were frequently resistant to co-trimoxazole (trimethoprim/sulfamethoxazole) (71.1%) but less so to azithromycin (22.4%), erythromycin (21.1%), chloramphenicol (18.4%), tetracycline (14.5%), clindamycin (10.5%) and levofloxacin (0%). Moreover, 26.3% were multidrug-resistant (resistant to ≥3 antibiotic classes). Vaccine-type pneumococci were resistant to more classes of antibiotics, were more frequently resistant to erythromycin, azithromycin, clindamycin and tetracycline, and had higher MICs to penicillin (median, 0.19μg/mL; range, 0.002-1.5μg/mL) compared with non-vaccine serotypes (median, 0.125μg/mL; range, 0.012-0.25μg/mL) (P=0.003). Co-trimoxazole-resistant isolates carried from 1 to 11 different mutations in the dihydrofolate reductase (DHFR) gene, most commonly Ile100Leu (100%), Glu20Asp (91.8%), Glu94Asp (61.2%), Leu135Phe (57.1%), His26Tyr (53.1%), Asp92Ala (53.1%) and His120Gln (53.1%).
CONCLUSION


Streptococcus pneumoniae isolated from HIV-diagnosed patients were frequently non-susceptible to penicillin and co-trimoxazole. Most isolates carried multiple mutations in DHFR.",2020,"Vaccine-type pneumococci were resistant to more classes of antibiotics; more frequently resistant to erythromycin, azithromycin, clindamycin and tetracycline, and had higher MIC-values towards penicillin (Median 0.19; range 0.002-1.5) versus non-vaccine types (Median 0.125; range 0.012-0.25), p = 0.003.","['1877 nasopharyngeal swabs were collected and screened for pneumococcal colonization from 537 newly diagnosed individuals with HIV at four clinic visits during a one-year follow-up from 2017 -2018', 'Twenty-six percent were multi-drug resistant (resistant to ≥3 antibiotic classes', 'Streptococcus pneumoniae isolates from HIV-infected adults in Dar es Salaam, Tanzania', 'Streptococcus pneumoniae isolated from HIV-infected adults in a community setting in Tanzania']","['clindamycin', 'tetracycline', 'erythromycin, azithromycin, clindamycin and tetracycline', 'levofloxacin', 'chloramphenicol', 'erythromycin', 'azithromycin']",['penicillin non-susceptible minimum inhibitory concentration (MIC'],"[{'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022595', 'cui_str': 'Darier disease'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0008947', 'cui_str': 'Clindamycin'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0008168', 'cui_str': 'Chloramphenicol'}]","[{'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0427978', 'cui_str': 'MIC'}]",1877.0,0.4074,"Vaccine-type pneumococci were resistant to more classes of antibiotics; more frequently resistant to erythromycin, azithromycin, clindamycin and tetracycline, and had higher MIC-values towards penicillin (Median 0.19; range 0.002-1.5) versus non-vaccine types (Median 0.125; range 0.012-0.25), p = 0.003.","[{'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Manyahi', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway; National Centre for Tropical Infectious Diseases, Department of Medicine, Haukeland University Hospital, Bergen, Norway; Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania. Electronic address: manyahijoel@yahoo.com.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Moyo', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway; Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': 'Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Langeland', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway; National Centre for Tropical Infectious Diseases, Department of Medicine, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Blomberg', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway; National Centre for Tropical Infectious Diseases, Department of Medicine, Haukeland University Hospital, Bergen, Norway.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2020.06.026']
1547,32658939,Minimal transmission in an influenza A (H3N2) human challenge-transmission model within a controlled exposure environment.,"Uncertainty about the importance of influenza transmission by airborne droplet nuclei generates controversy for infection control. Human challenge-transmission studies have been supported as the most promising approach to fill this knowledge gap. Healthy, seronegative volunteer 'Donors' (n = 52) were randomly selected for intranasal challenge with influenza A/Wisconsin/67/2005 (H3N2). 'Recipients' randomized to Intervention (IR, n = 40) or Control (CR, n = 35) groups were exposed to Donors for four days. IRs wore face shields and hand sanitized frequently to limit large droplet and contact transmission. One transmitted infection was confirmed by serology in a CR, yielding a secondary attack rate of 2.9% among CR, 0% in IR (p = 0.47 for group difference), and 1.3% overall, significantly less than 16% (p<0.001) expected based on a proof-of-concept study secondary attack rate and considering that there were twice as many Donors and days of exposure. The main difference between these studies was mechanical building ventilation in the follow-on study, suggesting a possible role for aerosols.",2020,"One transmitted infection was confirmed by serology in a CR, yielding a secondary attack rate of 2.9% among CR, 0% in IR (p = 0.47 for group difference), and 1.3% overall, significantly less than 16% (p<0.001) expected based on a proof-of-concept study secondary attack rate and considering that there were twice as many Donors and days of exposure.","[""Healthy, seronegative volunteer 'Donors' (n = 52""]",['intranasal challenge with influenza A/Wisconsin/67/2005 (H3N2). '],[],"[{'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0013018', 'cui_str': 'Donors'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}]",[],52.0,0.0134321,"One transmitted infection was confirmed by serology in a CR, yielding a secondary attack rate of 2.9% among CR, 0% in IR (p = 0.47 for group difference), and 1.3% overall, significantly less than 16% (p<0.001) expected based on a proof-of-concept study secondary attack rate and considering that there were twice as many Donors and days of exposure.","[{'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Nguyen-Van-Tam', 'Affiliation': 'Health Protection and Influenza Research Group, Division of Epidemiology and Public Heath, University of Nottingham School of Medicine, Nottingham, United Kingdom.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Killingley', 'Affiliation': 'Health Protection and Influenza Research Group, Division of Epidemiology and Public Heath, University of Nottingham School of Medicine, Nottingham, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Enstone', 'Affiliation': 'Health Protection and Influenza Research Group, Division of Epidemiology and Public Heath, University of Nottingham School of Medicine, Nottingham, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hewitt', 'Affiliation': 'Health Protection and Influenza Research Group, Division of Epidemiology and Public Heath, University of Nottingham School of Medicine, Nottingham, United Kingdom.'}, {'ForeName': 'Jovan', 'Initials': 'J', 'LastName': 'Pantelic', 'Affiliation': 'University of Maryland School of Public Health, Maryland Institute for Applied Environmental Health, College Park, Maryland, United States of America.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Grantham', 'Affiliation': 'University of Maryland School of Public Health, Maryland Institute for Applied Environmental Health, College Park, Maryland, United States of America.'}, {'ForeName': 'P Jacob', 'Initials': 'PJ', 'LastName': 'Bueno de Mesquita', 'Affiliation': 'University of Maryland School of Public Health, Maryland Institute for Applied Environmental Health, College Park, Maryland, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lambkin-Williams', 'Affiliation': 'hVIVO London, United Kingdom.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gilbert', 'Affiliation': 'hVIVO London, United Kingdom.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Mann', 'Affiliation': 'hVIVO London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Forni', 'Affiliation': 'hVIVO London, United Kingdom.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Noakes', 'Affiliation': 'University of Leeds School of Civil Engineering, Leeds, United Kingdom.'}, {'ForeName': 'Min Z', 'Initials': 'MZ', 'LastName': 'Levine', 'Affiliation': 'Centers for Disease Control and Prevention, Influenza Division, Atlanta, Georgia, United States of America.'}, {'ForeName': 'LaShondra', 'Initials': 'L', 'LastName': 'Berman', 'Affiliation': 'Centers for Disease Control and Prevention, Influenza Division, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lindstrom', 'Affiliation': 'Centers for Disease Control and Prevention, Influenza Division, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Cauchemez', 'Affiliation': 'Imperial College London, MRC Centre for Outbreak Analysis and Modelling, Department of Infectious Disease Epidemiology, London, United Kingdom.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Bischoff', 'Affiliation': 'Wake Forest School of Medicine, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Tellier', 'Affiliation': 'McGill University, Dept of Medicine, Montreal, Canada.'}, {'ForeName': 'Donald K', 'Initials': 'DK', 'LastName': 'Milton', 'Affiliation': 'University of Maryland School of Public Health, Maryland Institute for Applied Environmental Health, College Park, Maryland, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS pathogens,['10.1371/journal.ppat.1008704']
1548,32659699,A web-based daily care training to improve the quality of life of mothers of children with cerebral palsy: A randomized controlled trial.,"BACKGROUND


Mothers of moderately to severely affected children with cerebral palsy (CP) have to spend a long time to take care of their children. This time-consuming responsibility affects their physical and psychosocial health. Therefore, mothers as caregivers are required to receive special training to take care of their children.
AIMS


The aim of this study was to evaluate the effectiveness of a developed web-based intervention for daily care training of children with CP on their mothers' quality of life (QOL), anxiety, depression, stress, and their musculoskeletal pain.
METHODS AND PROCEDURES


This study was a single blind randomized controlled trial. 91 mothers of children with CP with Gross Motor Function Classification System (GMFCS) levels III, IѴ, and Ѵ, who aged from 4 to 12 years were assigned to the intervention and control groups using block randomization. Mothers in the control group received their routine face to face occupational therapy intervention and mothers in the intervention group received 12 weeks web-based intervention. QOL, depression, anxiety, stress, and pain were measured before and after the intervention in both groups.
OUTCOMES AND RESULTS


The results of analysis of covariance showed that after controlling the mean score of pretest of pain, the mean score of post-tests in the intervention and control groups was significantly different (P < 0.05). The mean scores of physical health and total QOL scores of post-tests in the intervention group were significantly higher than the control group with controlling pretest scores.
CONCLUSIONS AND IMPLICATIONS


Designed web-based intervention affects the caregivers' QOL and pain significantly. This intervention can be used to provide daily care training for mothers of children with CP.",2020,"The mean scores of physical health and total QOL scores of post-tests in the intervention group were significantly higher than the control group with controlling pretest scores.
","['91 mothers of children with CP with Gross Motor Function Classification System (GMFCS) levels III, IѴ, and Ѵ, who aged from 4 to 12 years', 'mothers of children with cerebral palsy', 'Mothers of moderately to severely affected children with cerebral palsy (CP', 'mothers of children with CP', 'children with CP on their mothers']","['special training', 'A web-based daily care training', 'routine face to face occupational therapy intervention and mothers in the intervention group received 12 weeks web-based intervention']","['quality of life', 'QOL, depression, anxiety, stress, and pain', 'mean score of pretest of pain', 'quality of life (QOL), anxiety, depression, stress, and their musculoskeletal pain', 'mean scores of physical health and total QOL scores of post-tests']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",91.0,0.0560542,"The mean scores of physical health and total QOL scores of post-tests in the intervention group were significantly higher than the control group with controlling pretest scores.
","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Nobakht', 'Affiliation': 'Pediatric Neurorehabilitation Research Center and Occupational Therapy Department, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rassafiani', 'Affiliation': 'Occupational Therapy Department, Faculty of Allied Health Sciences, Kuwait University, Kuwait. Pediatric Neurorehabilitation Research Center, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran. Electronic address: mrassafiani@yahoo.com.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Hosseini', 'Affiliation': 'Social Determinants of Health Research Center and Occupational Therapy Department, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hosseinzadeh', 'Affiliation': 'Biosatistics Department, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}]",Research in developmental disabilities,['10.1016/j.ridd.2020.103731']
1549,32660260,Efficacy of an Adjunctive Electrophysiological Test-Guided Left Atrial Posterior Wall Isolation in Persistent Atrial Fibrillation Without a Left Atrial Low-Voltage Area.,"BACKGROUND


Electrical remodeling precedes structural remodeling. In adjunctive left atrial (LA) low-voltage area (LVA) ablation to pulmonary vein isolation of atrial fibrillation (AF), LA areas without LVA have not been targeted for ablation. We studied the effect of adjunctive LA posterior wall isolation (PWI) on persistent AF without LA-LVA according to electrophysiological testing (EP test).
METHODS


We examined consecutive patients with persistent AF with (n=33) and without (n=111) LA-LVA. Patients without LA-LVA were randomly assigned to EP test-guided (n=57) and control (n=54) groups. In the EP test-guided group, an adjunctive PWI was performed in those with positive results (PWI subgroup; n=24), but not in those with negative results (n=33). The criteria for positive EP tests were an effective refractory period ≤180 ms, effective refractory period>20 ms shorter than the other sites, and/or induction of AF/atrial tachycardia (AT) during measurements. LVA ablation was performed in the patients with LA-LVA.
RESULTS


During the follow-up period (62±33 weeks), the EP test-guided group had significantly lower recurrence rates (19%,11/57 versus 41%, 22/54,  P =0.012) and higher Kaplan-Meier AF/AT-free survival curve rates than the control group ( P =0.01). No significant differences in the recurrence and AF/AT-free survival curve rates between the PWI (positive EP test) and non-PWI (negative EP test) subgroups were observed. Therefore, PWI for positive EP tests reduced the AF/AT recurrence in the EP test-guided group. A stepwise Cox proportional hazard analyses identified EP test-guided ablation as a factor reducing the recurrence rate. The recurrence rates in the LA-LVA ablation group and EP test-guided group were similar.
CONCLUSIONS


This pilot study proposed that an EP test-guided adjunctive PWI of persistent AF without LA-LVA potentially reduced AF/AT recurrences. The results suggest that there is an AF substrate in the LA with altered electrophysiological function even when there is no LA-LVA. Graphic Abstract: A graphic abstract is available for this article.",2020,No significant differences in the recurrence and AF/AT-free survival curve rates between the PWI (positive EP test) and non-PWI (negative EP test) subgroups were observed.,"['Patients without LA-LVA', 'consecutive persistent AF patients with (n=33) and without (n=111) LA-LVA']","['Adjunctive Electrophysiological Test-Guided Left Atrial Posterior Wall Isolation', 'adjunctive LA posterior wall isolation (PWI', 'LA-LVA ablation', 'EP test-guided', 'adjunctive left atrial (LA) low-voltage area (LVA) ablation', 'LVA ablation']","['recurrence and AF/AT-free survival curve rates', 'AF/AT recurrence', 'recurrence rates', 'recurrence rate', 'higher Kaplan-Meier AF/AT-free survival curve rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023128', 'cui_str': 'Latvia'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0023128', 'cui_str': 'Latvia'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0273246,No significant differences in the recurrence and AF/AT-free survival curve rates between the PWI (positive EP test) and non-PWI (negative EP test) subgroups were observed.,"[{'ForeName': 'Hirosuke', 'Initials': 'H', 'LastName': 'Yamaji', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Takeda 54-1, Naka-Ku, Japan (H.Y., S. Higashiya, T.M., K.H., H.K., M.M., S. Kamikawa, S. Kusachi).'}, {'ForeName': 'Shunichi', 'Initials': 'S', 'LastName': 'Higashiya', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Takeda 54-1, Naka-Ku, Japan (H.Y., S. Higashiya, T.M., K.H., H.K., M.M., S. Kamikawa, S. Kusachi).'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Takeda 54-1, Naka-Ku, Japan (H.Y., S. Higashiya, T.M., K.H., H.K., M.M., S. Kamikawa, S. Kusachi).'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Hina', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Takeda 54-1, Naka-Ku, Japan (H.Y., S. Higashiya, T.M., K.H., H.K., M.M., S. Kamikawa, S. Kusachi).'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kawamura', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Takeda 54-1, Naka-Ku, Japan (H.Y., S. Higashiya, T.M., K.H., H.K., M.M., S. Kamikawa, S. Kusachi).'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Murakami', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Takeda 54-1, Naka-Ku, Japan (H.Y., S. Higashiya, T.M., K.H., H.K., M.M., S. Kamikawa, S. Kusachi).'}, {'ForeName': 'Shigeshi', 'Initials': 'S', 'LastName': 'Kamikawa', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Takeda 54-1, Naka-Ku, Japan (H.Y., S. Higashiya, T.M., K.H., H.K., M.M., S. Kamikawa, S. Kusachi).'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Hirohata', 'Affiliation': 'Department of Medical Technology, Okayama University Graduate School of Health Sciences, Japan (S. Hirohata, S. Kusachi).'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Kusachi', 'Affiliation': 'Heart Rhythm Center, Okayama Heart Clinic, Takeda 54-1, Naka-Ku, Japan (H.Y., S. Higashiya, T.M., K.H., H.K., M.M., S. Kamikawa, S. Kusachi).'}]",Circulation. Arrhythmia and electrophysiology,['10.1161/CIRCEP.119.008191']
1550,32682049,"Employee perseverance in a ""no phone use while driving"" organizational road-safety intervention.","INTRODUCTION


This interdisciplinary study explores factors that contribute to the perseverance of participants in an organizational ""no phone use while driving"" road-safety intervention.
METHOD


The study sample comprised 200 employees (mean age 43 years; 104 females [52 %], 96 males [48 %]) from 8 organizations in Israel. Subjects completed a 4-month organizational intervention using a smartphone application that monitored smartphone use, operationalized as taps per minute, where each tap represents a single instance of contact with the screen (e.g., touching, tapping or swiping). The app also silenced notifications during the intervention stage. Changes over time in tapping-while-driving behavior were examined through self-report questionnaires and objectively through the application's monitoring function. Validated measures were used to examine factors associated with perseverance in the program.
RESULTS


Organizational safety climate and gender (male) were positively related to perseverance in the intervention. Contrary to our hypothesis, safety motivation was not found to influence perseverance.
CONCLUSIONS


The present intervention is most effective for employees with high safety climate perceptions and for male employees.
PRACTICAL APPLICATIONS


The organizational intervention presented in the current study was shown to be effective in reducing smartphone use (touching, tapping or swiping) while driving. Our findings show that people will download and use an app that actively reduces their incentive to use their phones at the wheel by silencing incoming notifications. The findings support calls to harness the positive potential of information and communications technologies for organizational interventions.",2020,"The organizational intervention presented in the current study was shown to be effective in reducing smartphone use (touching, tapping or swiping) while driving.","['employees with high safety climate perceptions and for male employees', '200 employees (mean age 43 years; 104 females [52 %], 96 males [48 %]) from 8 organizations in Israel']",[],['safety motivation'],"[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0022271', 'cui_str': 'Israel'}]",[],"[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",200.0,0.0146053,"The organizational intervention presented in the current study was shown to be effective in reducing smartphone use (touching, tapping or swiping) while driving.","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Rispler', 'Affiliation': 'Faculty of Welfare and Health Sciences, Department of Human Services, University of Haifa, Mount Carmel, Haifa, 31905, Israel. Electronic address: clararispler5510@gmail.com.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Luria', 'Affiliation': 'Faculty of Welfare and Health Sciences, Department of Human Services, University of Haifa, Mount Carmel, Haifa, 31905, Israel. Electronic address: gluria@univ.haifa.ac.il.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105689']
1551,32682494,"Glecaprevir-pibrentasvir to treat chronic hepatitis C virus infection in Asia: two multicentre, phase 3 studies- a randomised, double-blind study (VOYAGE-1) and an open-label, single-arm study (VOYAGE-2).","BACKGROUND


Glecaprevir-pibrentasvir results in high rates of sustained virological response in patients with chronic hepatitis C virus (HCV) genotype 1-6 infection. Data for glecaprevir-pibrentasvir in non-Japanese Asian patients have been minimal. The aim of these studies was to assess the efficacy and safety of glecaprevir-pibrentasvir in treatment-naive and treatment-experienced Asian patients with chronic HCV genotype 1-6 infection without cirrhosis (VOYAGE-1) and with compensated cirrhosis (VOYAGE-2).
METHODS


We did two phase 3 studies in treatment-naive and treatment-experienced patients with chronic HCV genotype 1-6 infection. VOYAGE-1 was a randomised, double-blind, placebo-controlled study that recruited patients without cirrhosis at 47 sites across China, South Korea, and Singapore. Randomisation was 2:1 with a fixed block size of three and stratified by geographical region and HCV genotype. Investigators, study site personnel, the study sponsor, and patients were masked to treatment allocation. VOYAGE-2 was a single-arm, open-label study that recruited patients with compensated cirrhosis at 34 sites across China and South Korea. Glecaprevir (300 mg) and pibrentasvir (120 mg) or placebo (VOYAGE-1, 2:1 ratio), administered as three tablets daily, was given for 8 weeks in patients without cirrhosis and for 12 weeks in those with cirrhosis (and for 16 weeks in treatment-experienced patients with genotype 3). The primary efficacy endpoint was the proportion of patients with a sustained virological response, defined as HCV RNA below the lower limit of quantification 12 weeks after the last dose of glecaprevir-pibrentasvir. We analysed efficacy and safety in all patients who received at least one dose of the study drug. These trials are registered with ClinicalTrials.gov, NCT03222583 (VOYAGE-1) and NCT03235349 (VOYAGE-2); both trials have been completed. This Article reports the results of the primary analysis for each study, undertaken when all patients who received glecaprevir-pibrentasvir (during the double-blind period in VOYAGE-1) had been followed up for 12 weeks following their last dose of study drug. Data from the double-blind period for placebo patients in VOYAGE-1 are also summarised.
FINDINGS


Between Oct 4, 2017, and April 20, 2018, 546 patients with chronic HCV without cirrhosis were randomly assigned to treatment (363 to glecaprevir-pibrentasvir, 183 to placebo) in VOYAGE-1. One patient withdrew consent and did not receive treatment with glecaprevir-pibrentasvir. 352 of 362 patients who received glecaprevir-pibrentasvir achieved SVR12 (97·2% [95% CI 95·5-98·9]). Of 160 patients with compensated cirrhosis who were enrolled in VOYAGE-2 between Sept 29, 2017, and June 14, 2018, 159 of 160 achieved SVR12 (99·4%, 95% CI 98·2-100·0). 20 patients with HCV genotype 3b across both trials received glecaprevir-pibrentasvir; six of these patients were among the 11 patients who did not achieve SVR12. Upper respiratory tract infection was the most common adverse event (35 [10%] of 362 receiving glecaprevir-pibrentasvir and 18 [10%] of 183 receiving placebo in VOYAGE-1; 19 [12%] of 160 in VOYAGE-2). For patients receiving glecaprevir-pibrentasvir, serious adverse events occurred in three (<1%) of 362 patients in VOYAGE-1 and five (3%) of 160 patients in VOYAGE-2. Grade 3-4 adverse events in patients receiving glecaprevir-pibrentasvir occurred in five (1%) of 362 patients in VOYAGE-1 and six (4%) of 160 patients in VOYAGE-2; each type of event was experienced by at most one patient within a study. One patient with cirrhosis discontinued study drug because of an adverse event.
INTERPRETATION


Glecaprevir-pibrentasvir showed high efficacy and an acceptable safety profile in these studies although responses were less common in the few patients with HCV genotype 3b. The results support the use of glecaprevir-pibrentasvir in these Asian populations.
FUNDING


AbbVie.",2020,Upper respiratory tract infection was the most common adverse event (35 [10%] of 362 receiving glecaprevir-pibrentasvir and 18 [10%] of 183 receiving placebo in VOYAGE-1; 19 [12%] of 160 in VOYAGE-2).,"['all patients who received at least one dose of the study drug', 'patients with chronic hepatitis C virus (HCV) genotype 1-6 infection', 'Asian patients with chronic HCV genotype 1-6 infection without cirrhosis (VOYAGE-1) and with compensated cirrhosis (VOYAGE-2', 'recruited patients without cirrhosis at 47 sites across China, South Korea, and Singapore', 'patients with compensated cirrhosis at 34 sites across China and South Korea', '546 patients with chronic HCV without cirrhosis', '352 of 362 patients who received', '160 patients with compensated cirrhosis who were enrolled in VOYAGE-2 between Sept 29, 2017, and June 14, 2018, 159 of 160 achieved SVR12 (99·4%, 95% CI 98·2-100·0', '20 patients with HCV genotype 3b across both trials received glecaprevir-pibrentasvir; six of these patients were among the 11 patients who did not achieve SVR12', 'non-Japanese Asian patients']","['glecaprevir-pibrentasvir', 'Glecaprevir', 'Glecaprevir-pibrentasvir', 'glecaprevir-pibrentasvir achieved SVR12', 'pibrentasvir (120 mg) or placebo', 'placebo']","['efficacy and safety', 'Upper respiratory tract infection', 'proportion of patients with a sustained virological response, defined as HCV RNA', 'serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C3805156', 'cui_str': 'Chronic hepatitis C virus genotype 1'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C1608426', 'cui_str': 'Compensated cirrhosis'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205432', 'cui_str': 'Compensated'}, {'cui': 'C1533728', 'cui_str': 'Hepatitis C virus genotype determination'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4519575', 'cui_str': 'glecaprevir and pibrentasvir'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C4519575', 'cui_str': 'glecaprevir and pibrentasvir'}, {'cui': 'C4519536', 'cui_str': 'glecaprevir'}, {'cui': 'C4519537', 'cui_str': 'pibrentasvir'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0369335', 'cui_str': 'Hepatitis C virus RNA'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",20.0,0.347295,Upper respiratory tract infection was the most common adverse event (35 [10%] of 362 receiving glecaprevir-pibrentasvir and 18 [10%] of 183 receiving placebo in VOYAGE-1; 19 [12%] of 160 in VOYAGE-2).,"[{'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ""Peking University Hepatology Institute, Peking University People's Hospital, Beijing, China; Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.""}, {'ForeName': 'Guiqiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Negar N', 'Initials': 'NN', 'LastName': 'Alami', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Center of Liver Diseases, Beijing Di Tan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jeong', 'Initials': 'J', 'LastName': 'Heo', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Pusan National University and Medical Research Institute, Busan, South Korea.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Department of Infectious Diseases, Rui Jin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Mingxiang', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Shenyang Sixth People's Hospital, Shenyang, China.""}, {'ForeName': 'Yoon Jun', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seng Gee', 'Initials': 'SG', 'LastName': 'Lim', 'Affiliation': 'National University Healthcare System, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Fredrick', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Hari V', 'Initials': 'HV', 'LastName': 'Kalluri', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Preethi', 'Initials': 'P', 'LastName': 'Krishnan', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Tripathi', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Niloufar', 'Initials': 'N', 'LastName': 'Mobashery', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Burroughs', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Armen', 'Initials': 'A', 'LastName': 'Asatryan', 'Affiliation': 'AbbVie, North Chicago, IL, USA.'}, {'ForeName': 'Jidong', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Liver Research Center, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jinlin', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Infectious Diseases and Hepatology Unit, State Key Laboratory of Organ Failure Research, Guangdong Provincial Key Laboratory of Viral Hepatitis Research, Nanfang Hospital, Southern Medical University, Guangzhou, China. Electronic address: jlhousmu@163.com.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30086-8']
1552,32650155,Comparative effects of water- and land-based combined exercise training in hypertensive older adults.,"OBJECTIVES


A randomized controlled trial was designed to compare water- and land-based combined (aerobic and resistance) exercise training programs on cardiometabolic parameters, functional fitness, and quality-of-life (QoL) in hypertensive older adults.
METHODS


Fifty-three participants were divided into three groups: 1) land-based exercise group (LET, n=17), 2) water-based exercise group (WET, n=16), and 3) control group (CON, n=20). All programs comprised of a 12-week supervised training program (three 1-hr sessions per week), followed by a 12-week self-supervised training program. Blood pressure (BP), glutathione peroxidase (GPx), total nitrite/nitrate (NOx-), malondialdehyde (MDA), high-sensitive C-reactive protein (hs-CRP), blood lipids, functional fitness, and QoL were assessed before and after each period.
RESULTS


Following the supervised period, systolic BP, rate-pressure product, GPx, NOx-, MDA, hs-CRP concentrations, physical and psychological domains, and overall QoL significantly improved in both training groups. Only the WET improved LDL-C and lipoprotein combine index. Meanwhile, the 30s chair-stand test and 2-min step test improved only in the LET. Succeeding the self-supervised period, systolic BP and NOx- concentration significantly improved in both training groups. Notwithstanding, the 30s chair-standing and arm curl tests improved only in the LET.
CONCLUSIONS


Both training programs rendered ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL with a higher progression in the LET. Nevertheless, metabolic variables were greater improved in the WET. Additionally, due to greater exercise participation, the WET program may be a useful tool in motivating hypertensive older adults to continuously exercise on their own.",2020,"Both training programs rendered ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL with a higher progression in the LET.","['hypertensive older adults', 'motivating hypertensive older adults', 'Fifty-three participants were divided into three groups: 1']","['water- and land-based combined (aerobic and resistance) exercise training programs', 'land-based exercise group (LET, n=17), 2) water-based exercise group (WET, n=16), and 3) control group (CON', 'supervised training program', 'water- and land-based combined exercise training']","['metabolic variables', 'ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL', 'cardiometabolic parameters, functional fitness, and quality-of-life (QoL', 'systolic BP and NOx- concentration', 'Blood pressure (BP), glutathione peroxidase (GPx), total nitrite/nitrate (NOx-), malondialdehyde (MDA), high-sensitive C-reactive protein (hs-CRP), blood lipids, functional fitness, and QoL', 'LDL-C and lipoprotein combine index', 'systolic BP, rate-pressure product, GPx, NOx-, MDA, hs-CRP concentrations, physical and psychological domains, and overall QoL']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0086562', 'cui_str': 'Energy Transfer, Linear'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",53.0,0.0142118,"Both training programs rendered ameliorated systolic BP, antioxidant capacity and inflammation, muscular strength, aerobic endurance and QoL with a higher progression in the LET.","[{'ForeName': 'Ratree', 'Initials': 'R', 'LastName': 'Ruangthai', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Jatuporn', 'Initials': 'J', 'LastName': 'Phoemsapthawee', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand. Electronic address: jatuporn.w@ku.th.'}, {'ForeName': 'Niromlee', 'Initials': 'N', 'LastName': 'Makaje', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Phornphon', 'Initials': 'P', 'LastName': 'Phimphaphorn', 'Affiliation': 'Department of Sports Science and Health, Faculty of Sports Science, Kasetsart University, Nakhon Pathom, Thailand.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104164']
1553,32652065,Single-unit vs multiple-unit transfusion in hemodynamically stable postpartum anemia: a pragmatic randomized controlled trial.,"BACKGROUND


The American Academy of Blood Banks recommends single-unit red cell transfusion protocols across medicine to reduce transfusion complications and the use of a scarce resource. There are minimal data regarding single-unit protocols in obstetrics.
OBJECTIVE


We aimed to compare single-unit vs multiple-unit transfusion protocols for treatment of hemodynamically stable postpartum anemia.
STUDY DESIGN


We performed a randomized trial comparing initial transfusion with 1 unit of packed red blood cells (single-unit protocol) to 2 units of packed red blood cells (multiple-unit protocol) from March 2018 to July 2019. Women who required transfusion >6 hours postpartum were approached for consent. Unstable vital signs, hemoglobin level <5 g/dL, hemoglobinopathy, and cardiomyopathy were exclusion criteria for enrollment. Hemoglobin assessment and standardized clinical evaluation were performed 4 to 6 hours posttransfusion; additional packed red blood cells were given if indicated. The primary outcome was total units transfused. Secondary outcomes included length of stay, endometritis, wound separation or infection, venous thromboembolism, and intensive care unit admission within 30 days postpartum. Breastfeeding, depression, maternal attachment, and fatigue scores were assessed at 4 to 9 weeks postpartum. A total of 66 women were required to detect a 20% reduction in units transfused with a single-unit protocol (power=80%; α=0.05).
RESULTS


A total of 66 women were randomized (33 per arm). There were no differences between groups in demographic or clinical characteristics, including delivery mode, blood loss, and randomization hemoglobin levels. The mean number of units transfused was lower in the single-unit protocol than in the multiple-unit protocol (1.2 U vs 2.1 U; P<.001). Only 18.2% of women in the single-unit arm required additional packed red blood cells. At posttransfusion assessment, women in the single-unit arm had lower hemoglobin levels (7.8 g/dL vs 8.7 g/dL; P<.001), but there were no differences in vital signs or symptoms between groups. There were also no differences in length of stay, 30-day complications, or 4 to 9 week postpartum outcomes.
CONCLUSION


In women with hemodynamically stable postpartum anemia, a single-unit protocol avoided a second unit of packed red blood cells in >80% of women without significant impact on morbidity. Our work supports the use of single-unit initial transfusion in this population.",2020,"There were also no differences in length of stay, 30-day complications, or 4-9 week postpartum outcomes.
","['hemodynamically stable postpartum anemia', 'women with hemodynamically stable postpartum anemia', '66 women were randomized (33/arm', '66 women']","['single- vs. multiple-unit transfusion protocol', 'initial transfusion with 1 unit of packed red blood cells [pRBCs', 'Single- versus multiple-unit transfusion']","['length of stay, 30-day complications', 'length of stay, endometritis, wound separation/infection, venous thromboembolism, and intensive care unit admission within 30 days postpartum', 'Breastfeeding, depression, maternal attachment, and fatigue scores', 'Hemoglobin assessment and standardized clinical evaluation', 'vital signs or symptoms', 'morbidity', 'additional pRBCs', 'demographic or clinical characteristics, including delivery mode, blood loss, and randomization Hb', 'total units transfused', 'Mean number of units transfused']","[{'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}, {'cui': 'C0156847', 'cui_str': 'Anaemia, postpartum'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C2316467', 'cui_str': 'Packed red blood cells'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C2316467', 'cui_str': 'Packed red blood cells'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449961', 'cui_str': 'Number of units'}]",66.0,0.180712,"There were also no differences in length of stay, 30-day complications, or 4-9 week postpartum outcomes.
","[{'ForeName': 'Rebecca F', 'Initials': 'RF', 'LastName': 'Hamm', 'Affiliation': 'Maternal and Child Health Research Center, Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. Electronic address: Rebecca.feldmanhamm@uphs.upenn.edu.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Perelman', 'Affiliation': 'Maternal and Child Health Research Center, Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Eileen Y', 'Initials': 'EY', 'LastName': 'Wang', 'Affiliation': 'Maternal and Child Health Research Center, Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Levine', 'Affiliation': 'Maternal and Child Health Research Center, Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Sindhu K', 'Initials': 'SK', 'LastName': 'Srinivas', 'Affiliation': 'Maternal and Child Health Research Center, Department of Obstetrics and Gynecology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.07.007']
1554,32652112,"Identifying oncogenic drivers associated with increased risk of late distant recurrence in postmenopausal, estrogen receptor-positive, HER2-negative early breast cancer: results from the BIG 1-98 study.","BACKGROUND


In postmenopausal, estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer, the risk for distant recurrence can extend beyond 5 years of adjuvant endocrine therapy. This study aims to identify genomic driver alterations associated with late distant recurrence.
PATIENTS AND METHODS


Next generation sequencing was used to characterize driver alterations in primary tumors from a subset of 764 postmenopausal estrogen receptor-positive/HER2-negative patients from the BIG 1-98 randomized trial. Late distant recurrence events were defined as ≥5 years from time of randomization). The association of driver alterations with distant recurrence-free interval in early and late time periods was assessed using Cox regression models. Multivariable analyses were carried out to adjust for clinicopathological factors. Weighted analysis methods were used in order to correct for over-sampling of distant recurrences.
RESULTS


A total of 538 of 764 (70%) samples were successfully sequenced including 88 (63%) early and 52 (37%) late distant recurrence events after a median follow up of 8.1 years. In univariable analysis for late distant recurrence, PIK3CA mutations (58.8%) were significantly associated with reduced risk [hazard ratio (HR) 0.40, 95% confidence interval (CI) 0.20-0.82, P = 0.012], whereas amplifications on chromosome 8p11 (10.9%) (HR 4.79, 95% CI 2.30-9.97, P < 0.001) and BRCA2 mutations (2.3%) (HR 5.39, 95% CI 1.51-19.29, P = 0.010) were significantly associated with an increased risk. In multivariable analysis, only amplifications on 8p11 (P = 0.002) and BRCA2 mutations (P = 0.013) remained significant predictors.
CONCLUSIONS


In estrogen receptor-positive/HER2-negative postmenopausal early breast cancer, PIK3CA mutations were associated with reduced risk of late distant recurrence, whereas amplifications on 8p11 and BRCA2 mutations were associated with increased risk of late distant recurrence. The characterization of oncogenic driver alterations may aid in refining treatment choices in the late disease setting, and help identify potential drug targets for testing in future trials.",2020,"In multivariable analysis, only amplifications on 8p11 (P=0.002) and BRCA2 mutations (P=0.013) remained significant predictors.
",['primary tumors from a subset of 764 postmenopausal ER+/HER2- patients from the BIG 1-98 randomized trial'],[],"['Late distant recurrence events', 'late distant recurrence events', 'risk of late distant recurrence', 'BRCA2 mutations']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1511024', 'cui_str': 'BRCA2 gene mutation'}]",,0.192938,"In multivariable analysis, only amplifications on 8p11 (P=0.002) and BRCA2 mutations (P=0.013) remained significant predictors.
","[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Luen', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Lee', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Savas', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kammler', 'Affiliation': 'International Breast Cancer Study Group, Coordinating Center, Central Pathology Office, Bern, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': ""Dell'Orto"", 'Affiliation': 'International Breast Cancer Study Group Central Pathology Office, Department of Pathology, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'O M', 'Initials': 'OM', 'LastName': 'Biasi', 'Affiliation': 'Division of Pathology and Laboratory Medicine, IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Demanse', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Hackl', 'Affiliation': 'OncogenomX Inc., Allschwil, Basel, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thuerlimann', 'Affiliation': 'Breast Center, Cantonal Hospital, St Gallen, Switzerland; Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'Department of Pathology, University of Milan, Milan, Italy; IEO European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Di Leo', 'Affiliation': 'Sandro Pitigliani Department of Medical Oncology, Hospital of Prato, Prato, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'Division of Medical Senology, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'International Breast Cancer Study Group Statistical Center, Division of Biostatistics, Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loi', 'Affiliation': 'Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia. Electronic address: sherene.loi@petermac.org.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.06.024']
1555,32653324,"Re: Michael S. Hofman, Nathan Lawrentschuk, Roslyn J. Francis, et al. Prostate-specific Membrane Antigen PET-CT in Patients with High-risk Prostate Cancer Before Curative-intent Surgery or Radiotherapy (proPSMA): A Prospective, Randomised, Multi-centre Study. Lancet 2020;395:1208-16: PSMA Positron Emission Tomography: One Tracer Fixes Them All!",,2020,,['Patients with High-risk Prostate Cancer'],"['Curative-intent Surgery or Radiotherapy (proPSMA', 'PSMA Positron Emission Tomography', 'Prostate-specific Membrane Antigen PET-CT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}]",[],,0.0263993,,"[{'ForeName': 'Egesta', 'Initials': 'E', 'LastName': 'Lopci', 'Affiliation': 'Nuclear Medicine Department, Humanitas Clinical and Research Hospital - IRCCS, Rozzano, Italy. Electronic address: egesta.lopci@humanitas.it.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Lazzeri', 'Affiliation': 'Urology Department, Humanitas Clinical and Research Hospital - IRCCS, Rozzano, Italy.'}]",European urology,['10.1016/j.eururo.2020.06.054']
1556,32653539,The management of diabetes in everyday life study: Design and methods for a pragmatic randomized controlled trial comparing the effectiveness of text messaging versus health coaching.,"Background African American patients with uncontrolled diabetes living in medically underserved areas need effective clinic-based interventions to improve self-care behaviors. Text messaging (TM) and health coaching (HC) are among the most promising low-cost population-based approaches, but little is known about their comparative effectiveness in real-world clinical settings. Objective Use a pragmatic randomized controlled trial design to determine the comparative effectiveness of TM and HC with enhanced usual care (EC) in African American adults with uncontrolled diabetes and multiple chronic health conditions. Methods/design The Management of Diabetes in Everyday Life (MODEL) study is randomizing 646 patients (n = 581with anticipated 90% retention) to 3 intervention arms: TM, HC, and EC. Participants are African American adults living in medically underserved areas of the Mid-South, age ≥ 18, with uncontrolled diabetes (A1c ≥ 8), one or more additional chronic conditions, and who have a phone with texting and voicemail capability. Primary outcome measures: the general diet, exercise, and medication adherence subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessed at one year. Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c). The study will also assess heterogeneity of treatment effects by six key baseline participant characteristics. Conclusions We describe the design and methods of the MODEL study along with design revisions required during implementation in a pragmatic setting. This trial, upon its conclusion, will allow us to compare the effectiveness of two promising low-cost primary care-based strategies for supporting self-care behaviors among African Americans individuals with uncontrolled diabetes. ClinicalTrials.gov registration number: NCT02957513.",2020,"Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c).","['African American adults with uncontrolled diabetes and multiple chronic health conditions', ' African American patients with uncontrolled diabetes living in medically underserved areas', 'Participants are African American adults living in medically underserved areas of the Mid-South, age ≥ 18, with uncontrolled diabetes (A1c ≥ 8), one or more additional chronic conditions, and who have a phone with texting and voicemail capability', '646 patients (n\u202f=\u202f581with anticipated 90% retention) to 3 intervention arms: TM, HC, and EC', 'African Americans individuals with uncontrolled diabetes']","['Text messaging (TM) and health coaching (HC', 'text messaging versus health coaching', 'TM and HC with enhanced usual care (EC']","['diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c', 'general diet, exercise, and medication adherence subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessed at one year']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C3266262', 'cui_str': 'Multiple chronic diseases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0025112', 'cui_str': 'Area, Medically Underserved'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0301563', 'cui_str': 'General diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",646.0,0.105121,"Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c).","[{'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Bailey', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of General Internal Medicine, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America. Electronic address: jeb@uthsc.edu.'}, {'ForeName': 'Satya', 'Initials': 'S', 'LastName': 'Surbhi', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of General Internal Medicine, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Gatwood', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; College of Pharmacy, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Butterworth', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Q-consult, LLC, St. Petersburg, FL, United States of America.'}, {'ForeName': 'Mace', 'Initials': 'M', 'LastName': 'Coday', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Sohul A', 'Initials': 'SA', 'LastName': 'Shuvo', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Institute for Health Outcomes and Policy, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Ankur A', 'Initials': 'AA', 'LastName': 'Dashputre', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Institute for Health Outcomes and Policy, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Brooks', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Surgery, Anne Arundel Medical Center, Annapolis, MD, United States of America.'}, {'ForeName': 'Bonnie L', 'Initials': 'BL', 'LastName': 'Binkley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Carrie Jo', 'Initials': 'CJ', 'LastName': 'Riordan', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Helmut O', 'Initials': 'HO', 'LastName': 'Steinberg', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Division of Endocrinology, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Gutierrez', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Haley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Cardella L', 'Initials': 'CL', 'LastName': 'Leak', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Tolley', 'Affiliation': 'Center for Health System Improvement, University of Tennessee Health Science Center, Memphis, TN, United States of America; Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis, TN, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106080']
1557,32653580,Investigation of the Effects of Dual-Task Balance Training on Gait and Balance in Transfemoral Amputees: A Randomized Controlled Trial.,"OBJECTIVES


To investigate the effects of dual-task balance training on static and dynamic balance, functional mobility, cognitive level, and sleep quality in individuals with transfemoral amputation.
DESIGN


Randomized controlled clinical trial.
PARTICIPANTS


Transfemoral amputees (N=20).
INTERVENTIONS


Participants were randomly assigned to the single-task gait and balance training group (n=10) or the dual-task gait and balance training group (n=10). Training was given in sessions of 60 min/d, 3 d/wk for 4 weeks. The single-task training group performed traditional gait and balance exercises, and the dual-task training group practiced cognitive and motor tasks while performing gait and balance exercises.
MAIN OUTCOME MEASURES


The 1-leg stance test and the Four Square Step Test were used for balance assessment. The timed Up and Go test and 10-m walk test were used for gait assessment. Three test conditions to evaluate the training effects were single walking, walking while performing a cognitive task (serial subtraction), and walking while performing a motor task (tray carrying). The Montreal Cognitive Assessment scale was used for cognitive assessment and the Pittsburgh Sleep Quality Index for sleep quality assessment.
RESULTS


Balance and mobility improved in both groups. Dual-task balance performance, functional mobility, and gait speed improved more in the dual-task training group after training (P<.05). Cognitive status and sleep quality improved significantly in the dual-task group (P<.05).
CONCLUSIONS


Dual-task training was more effective than single-task training in the improvement of dual-task performance and cognitive status. The inclusion of dual-task exercises in the rehabilitation program of transfemoral amputees will provide a different perspective because of increased task automation.",2020,"Dual task balance performance, functional mobility and gait speed improved more in the dual task training group after training (p <0.05).","['Transfemoral amputees (n=20', 'Transfemoral Amputees', 'individuals with transfemoral amputation']","['single task gait and balance training group (n=10) or the dual task task gait and balance training group', 'single task training group performed traditional gait and balance exercises, and the dual task training group practised cognitive and motor tasks while performing gait and balance exercises', 'single walking, walking while performing a cognitive task (serial subtraction), and walking while performing a motor task (tray-carrying', 'dual task balance training', 'Dual Task Balance Training', 'Dual-task training']","['Balance and mobility', 'cognitive assessment and the Pittsburgh Sleep Quality Index for sleep quality assessment', 'Gait and Balance', 'Montreal Cognitive Assessment scale', 'static and dynamic balance, functional mobility, cognitive level, and sleep quality', 'dual task performance and cognitive status', 'leg stance test and the four-square step test', 'Dual task balance performance, functional mobility and gait speed', 'Cognitive status and sleep quality']","[{'cui': 'C0002695', 'cui_str': 'Amputee'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002691', 'cui_str': 'Amputation above-knee'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0184054', 'cui_str': 'Tray'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",,0.014124,"Dual task balance performance, functional mobility and gait speed improved more in the dual task training group after training (p <0.05).","[{'ForeName': 'Senem', 'Initials': 'S', 'LastName': 'Demirdel', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey. Electronic address: fzt_sb@hotmail.com.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Erbahçeci', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.06.009']
1558,32658765,Assessment of stress markers in restrained individuals following physical stress with and without sham CED activation.,"INTRODUCTION


Law enforcement and pre-hospital care personnel often confront individuals who must be physically restrained. Many are under the influence of illicit substances, and law enforcement officers may need to use a controlled electrical device (CED) to gain control of the individual and they are often placed into the prone maximum restraint (PMR) position. These techniques have previously been evaluated for their physiologic effects. The purpose of this study was to investigate the psychological effects of anticipating and experiencing a sham CED activation in healthy human subjects who were exercised and restrained compared with no sham activation by assessing the differences in a panel of several known biomarkers of stress.
METHODS


We performed a randomized, crossover controlled human subject trial to study the stress associated with exercise, physical exhaustion, and restraint with and without an added psychological stress simulating the field use of a CED. Twenty five total subjects; each subject performed two different trials each consisting of a brief period of intense exercise on a treadmill to exhaustion followed by placement in the PMR with and without induced psychological stress. Blood samples were collected for analysis pre and post exercise, as well as 10 min after completion of the exercise. A panel of hormones and stress markers were measured.
RESULTS


We found no significant differences in any of the stress biomarkers measured between the two study groups. A trend towards higher levels of copeptin was measured in the sham CED activation arm.
CONCLUSION


During a brief period of intense exercise followed by the psychological stress of anticipated CED application, there did not appear to be statistically significant changes in the stress panel of biomarkers measured, only a trend towards significance for higher copeptin levels in the patients exposed to the psychological stress.",2020,We found no significant differences in any of the stress biomarkers measured between the two study groups.,"['healthy human subjects', 'Twenty five total subjects']",['intense exercise on a treadmill to exhaustion followed by placement in the PMR with and without induced psychological stress'],"['stress biomarkers', 'levels of copeptin']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0056279', 'cui_str': 'copeptins'}]",25.0,0.0515782,We found no significant differences in any of the stress biomarkers measured between the two study groups.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Sloane', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA. Electronic address: csloane@ucsd.edu.'}, {'ForeName': 'Deborah C', 'Initials': 'DC', 'LastName': 'Mash', 'Affiliation': 'Department of Neurology, Molecular and Cellular Pharmacology, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Theodore C', 'Initials': 'TC', 'LastName': 'Chan', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Kolkhorst', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University San Diego, CA, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Neuman', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Castillo', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lasoff', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Wardi', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA; Division of Pulmonary, Critical Care, and Sleep Medicine, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Neurology, Molecular and Cellular Pharmacology, University of Miami, Miami, FL, USA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Vilke', 'Affiliation': 'Department of Emergency Medicine, University of California, San Diego, CA, USA.'}]",Journal of forensic and legal medicine,['10.1016/j.jflm.2020.101982']
1559,32660347,Effects of Transcranial Direct Current Stimulation Over the Dorsolateral Prefrontal Cortex (PFC) on Cognitive-Motor Dual Control Skills.,"This randomized crossover study investigated whether anodal transcranial direct current stimulation (tDCS) over the dorsolateral prefontal cortex (dlPFC) modulates memory-guided finger isometric maintenance during single motor and dual cognitive-motor tasks, based on electroencephalogram (EEG) signals. Twenty-three healthy participants (14 female;  M  age = 29.130 years,  SD  = 10.918) underwent both sham and 2-mA stimulation sessions over the dlPFC for 20 minutes, with a minimum washout period of seven days. We analyzed finger-force isometric maintenance and event-related spectral perturbation (ERSP) of the EEG during early and later phases of both tasks. We observed a significant motor accuracy improvement ( p  = .014) and significant variation of force output ( p  = .027) with significant decrease in ERSP on the dorsomedial prefrontal cortex (dmPFC) (early phase,  p  = .027; later phase,  p  = .023) only after 2 mA stimulation. Thus, anodal tDCS over the dlPFC may improve memory-guided force control during cognitive-motor dual tasks.",2020,"We observed a significant motor accuracy improvement ( p  = .014) and significant variation of force output ( p  = .027) with significant decrease in ERSP on the dorsomedial prefrontal cortex (dmPFC) (early phase,  p  = .027; later phase,  p  = .023) only after 2 mA stimulation.","['Twenty-three healthy participants (14 female;  M  age\u2009=\u200929.130 years,  SD \u2009=\u200910.918) underwent both']","['sham and 2-mA stimulation sessions', 'Transcranial Direct Current Stimulation', 'anodal transcranial direct current stimulation (tDCS']","['motor accuracy improvement', 'ERSP on the dorsomedial prefrontal cortex (dmPFC', 'force output']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}]",23.0,0.0297066,"We observed a significant motor accuracy improvement ( p  = .014) and significant variation of force output ( p  = .027) with significant decrease in ERSP on the dorsomedial prefrontal cortex (dmPFC) (early phase,  p  = .027; later phase,  p  = .023) only after 2 mA stimulation.","[{'ForeName': 'JaeHyuk', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Major in Rehabilitation Science, Graduate School, Korea University.'}, {'ForeName': 'SungHee', 'Initials': 'S', 'LastName': 'Dong', 'Affiliation': 'Department of Brain and Cognitive Engineering, Korea University.'}, {'ForeName': 'JiChai', 'Initials': 'J', 'LastName': 'Jeong', 'Affiliation': 'Department of Brain and Cognitive Engineering, Korea University.'}, {'ForeName': 'BumChul', 'Initials': 'B', 'LastName': 'Yoon', 'Affiliation': 'Major in Rehabilitation Science, Graduate School, Korea University.'}]",Perceptual and motor skills,['10.1177/0031512520935695']
1560,32660475,Evidence of high bed net usage from a list randomization experiments in rural Gambia.,"BACKGROUND


Recording behaviours that have the potential to impact health can be doubly challenging if the behaviour takes place in private spaces that cannot be observed directly, and where respondents answer what they think the recorder may want to hear. Sleeping under a long-lasting insecticidal net (LLIN) is an important intervention for malaria prevention, yet it is difficult to gauge the extent to which coverage (how many nets are in the community) differs from usage (how many people actually sleep under a net). List randomization, a novel method which partially obscures respondents' answers to sensitive questions, was employed to estimate LLIN usage in The Gambia.
METHODS


802 heads-of-household from 15 villages were recruited into a randomized controlled trial assessing the effect of a housing intervention on malaria. These houses were randomly assigned to a housing intervention versus control, with stratification by village so as to ensure balance between arms. From these, 125 households (63 intervention, 52 control) were randomly selected for participation in the list randomization experiment, along with 68 households from the same villages but which were not part of the housing improvement study, resulting in a total of 196 households for the list randomization experiment. Approximately half (n = 97) of the 196 study participants were randomly assigned to the control group and received a four-question list about non-sensitive behaviours; the intervention group (n = 99) received the same list, with the addition of one question on a sensitive behaviour: whether or not they had used a bed net the previous night. Participants were read the list of questions and then said how many of the statements were true. Bed net usage was estimated by calculating the difference in means between the number of affirmative responses between the two groups.
RESULTS


The mean number of affirmative responses in the control group was 2.60 of four statements (95% confidence interval, 95% CI 2.50-2.70), compared with 3.68 (95% CI 3.59-3.78) in the intervention group. Such difference (1.08; 95% CI 94.9-100%) suggests near universal bed net usage.
CONCLUSIONS


Bed net usage by household heads in these rural villages was found to be high. Though not entirely unexpected given other studies' estimates of high bed net usage in the area, the list randomization method should be further validated in an area with lower coverage.",2020,"The mean number of affirmative responses in the control group was 2.60 of four statements (95% confidence interval, 95% CI 2.50-2.70), compared with 3.68 (95% CI 3.59-3.78) in the intervention group.","['125 households (63 intervention, 52 control) were randomly selected for participation in the list randomization experiment, along with 68 households from the same villages but which were not part of the housing improvement study, resulting in a total of 196 households for the list randomization experiment', 'rural Gambia', 'Approximately half (n\u2009=\u200997) of the 196 study participants', '802 heads-of-household from 15 villages']","['control group and received a four-question list about non-sensitive behaviours; the intervention group', 'Sleeping under a long-lasting insecticidal net (LLIN', 'housing intervention', 'housing intervention versus control']",['mean number of affirmative responses'],"[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0016993', 'cui_str': 'The Gambia'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0018677', 'cui_str': 'Head of Household'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0020056', 'cui_str': 'Housed'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",196.0,0.0788638,"The mean number of affirmative responses in the control group was 2.60 of four statements (95% confidence interval, 95% CI 2.50-2.70), compared with 3.68 (95% CI 3.59-3.78) in the intervention group.","[{'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Brew', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain. joebrew@gmail.com.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Pinder', 'Affiliation': 'Medical Research Council Unit, The Gambia at the London, School of Hygiene and Tropical Medicine, PO Box 273, Banjul, The Gambia.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': ""D'Alessandro"", 'Affiliation': 'Medical Research Council Unit, The Gambia at the London, School of Hygiene and Tropical Medicine, PO Box 273, Banjul, The Gambia.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lindsay', 'Affiliation': 'Department of Biosciences, Durham University, Stockton Road, Durham, DH1 3LE, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Medical Research Council Unit, The Gambia at the London, School of Hygiene and Tropical Medicine, PO Box 273, Banjul, The Gambia.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Sicuri', 'Affiliation': 'ISGlobal, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.'}]",Malaria journal,['10.1186/s12936-020-03322-5']
1561,32660496,"The impact of an audience response system on a summative assessment, a controlled field study.","BACKGROUND


Audience response systems allow to activate the audience and to receive a direct feedback of participants during lectures. Modern systems do not require any proprietary hardware anymore. Students can directly respond on their smartphone. Several studies reported about a high level of satisfaction of students when audience response systems are used, however their impact on learning success is still unclear.
METHODS


In order to evaluate the impact of an audience response system on the learning success we implemented the audience response system eduVote into a seminar series and performed a controlled crossover study on its impact on assessments. One hundred fifty-four students in nine groups were taught the same content. In four groups, eduVote was integrated for the first topic while five groups were taught this topic without the audience response systems. For a second topic, the groups were switched: Those groups who were taught before using eduVote were now taught without the audience response system and vice versa. We then analysed the impact of the audience response system on the students' performance in a summative assessment and specifically focused on questions dealing with the topic, for which the audience response system was used during teaching. We further assessed the students' perception on the use of eduVote using questionnaires.
RESULTS


In our controlled crossover study we could not confirm an impact of the audience response system eduVote on long-term persistence i.e. the students' performance in the summative assessment. Our evaluation revealed that students assessed the use of eduVote very positively, felt stronger engaged and better motivated to deal with the respective topics and would prefer their integration into additional courses as well. In particular we identified that students who feel uncomfortable with answering questions in front of others profit from the use of an audience response system during teaching.
CONCLUSIONS


Audience response systems motivate and activate students and increase their engagement during classes. However, their impact on long-term persistence and summative assessments may be limited. Audience response systems, however, specifically allow activating students which cannot be reached by the traditional way of asking questions without such an anonymous tool.",2020,In our controlled crossover study we could not confirm an impact of the audience response system eduVote on long-term persistence i.e. the students' performance in the summative assessment.,"['students who feel uncomfortable with answering questions in front of others profit from the use of an audience response system during teaching', 'One hundred fifty-four students in nine groups were taught the same content']",[],[],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}]",[],[],154.0,0.0185939,In our controlled crossover study we could not confirm an impact of the audience response system eduVote on long-term persistence i.e. the students' performance in the summative assessment.,"[{'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Schmidt', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany. Thorsten.Schmidt@med.uni-tuebingen.de.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Gazou', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Rieß', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Rieß', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Grundmann-Hauser', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Falb', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Malou', 'Initials': 'M', 'LastName': 'Schadeck', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Tilman', 'Initials': 'T', 'LastName': 'Heinrich', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Mahkameh', 'Initials': 'M', 'LastName': 'Abeditashi', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Ulrike A', 'Initials': 'UA', 'LastName': 'Mau-Holzmann', 'Affiliation': 'Institute of Medical Genetics and Applied Genomics, University of Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany.'}, {'ForeName': 'Kai P', 'Initials': 'KP', 'LastName': 'Schnabel', 'Affiliation': 'Institute for Medical Education, Department for Education and Media, University of Bern, Bern, Switzerland.'}]",BMC medical education,['10.1186/s12909-020-02130-4']
1562,32660770,Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older.,"PURPOSE


Chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) are common functional gastrointestinal disorders. The prevalence of constipation-related issues tends to increase with age. This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.
METHODS


Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled. Efficacy end points common to all trials included changes in stool consistency (Bristol Stool Form Scale), changes in weekly frequency of complete spontaneous bowel movements (CSBMs) and spontaneous bowel movements (SBMs), and time to first CSBM and SBM. Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).
FINDINGS


The pooled intention-to-treat population comprised 451 patients aged ≥65 years (mean age, 70 years) and 4364 patients aged <65 years (mean age, 41.9 years), of whom 287 and 2914, respectively, were randomized to receive plecanatide. Compared with placebo, plecanatide produced statistically significant improvements in stool consistency from baseline at week 12 (both age groups), CSBM and SBM frequency from baseline at week 12 (plecanatide 3 mg group aged ≥65 years and both plecanatide groups aged <65 years), and time from start of therapy to first CSBM (both age groups) and SBM (plecanatide 6 mg group aged ≥65 years and both plecanatide groups aged <65 years). No new safety issues were observed.
IMPLICATIONS


Plecanatide is a well-tolerated and effective treatment option for patients aged ≥65 years with CIC or IBS-C. CLINICALTRIALS.
GOV IDENTIFIERS


NCT01982240, NCT02122471, NCT02387359, and NCT02493452.",2020,"Plecanatide is a well-tolerated and effective treatment option for patients aged ≥65 years with CIC or IBS-C. CLINICALTRIALS.
","['group aged ≥65 years and both plecanatide groups aged <65 years', 'patients aged ≥65 years', 'per age group (≥65 and\xa0<65 years of age', 'Patients 65\xa0Years or Older', 'Chronic Idiopathic Constipation and Irritable Bowel Syndrome', 'patients aged ≥65 years with CIC or IBS-C. CLINICALTRIALS', '451 patients aged ≥65 years (mean age, 70 years) and 4364 patients aged <65 years (mean age, 41.9 years), of whom 287 and 2914, respectively', 'Chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C']","['Plecanatide', 'plecanatide', 'SBM (plecanatide 6\xa0mg', 'placebo, plecanatide', 'placebo']","['stool consistency', 'Efficacy and safety profile', 'safety and efficacy', 'CSBM and SBM frequency', 'stool consistency (Bristol Stool Form Scale), changes in weekly frequency of complete spontaneous bowel movements (CSBMs) and spontaneous bowel movements (SBMs), and time to first CSBM and SBM']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3711911', 'cui_str': 'plecanatide'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0267509', 'cui_str': 'Chronic idiopathic constipation'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517682', 'cui_str': '287'}]","[{'cui': 'C3711911', 'cui_str': 'plecanatide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1997606', 'cui_str': 'Bristol stool form scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",4364.0,0.130648,"Plecanatide is a well-tolerated and effective treatment option for patients aged ≥65 years with CIC or IBS-C. CLINICALTRIALS.
","[{'ForeName': 'Stacy B', 'Initials': 'SB', 'LastName': 'Menees', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA; Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI, USA. Electronic address: sbartnik@med.umich.edu.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Franklin', 'Affiliation': 'Salix Pharmaceuticals Inc., Bridgewater, NJ, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Chey', 'Affiliation': 'Michigan Bowel Control Program, University of Michigan, Ann Arbor, MI, USA.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.05.012']
1563,32661682,"Within-group comparisons led to unsubstantiated conclusions in ""Low-phytate wholegrain bread instead of high-phytate wholegrain bread in a total diet context did not improve iron status of healthy Swedish females: a 12-week, randomized, parallel-design intervention Study"".",,2020,,['healthy Swedish females'],[],[],"[{'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],[],,0.027488,,"[{'ForeName': 'Colby J', 'Initials': 'CJ', 'LastName': 'Vorland', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA. cvorland@iu.edu.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Mestre', 'Affiliation': 'Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA.'}, {'ForeName': 'Sachintha S', 'Initials': 'SS', 'LastName': 'Mendis', 'Affiliation': 'Department of Agricultural and Resource Economics, Colorado State University, Fort Collins, CO, USA.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Brown', 'Affiliation': 'Department of Applied Health Science, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA. awb1@iu.edu.'}]",European journal of nutrition,['10.1007/s00394-020-02287-0']
1564,32664995,Survival outcomes and clinical benefit in patients with acute myeloid leukemia treated with glasdegib and low-dose cytarabine according to response to therapy.,"BACKGROUND


The phase 2 BRIGHT AML 1003 trial evaluated efficacy and safety of glasdegib + low-dose cytarabine (LDAC) in patients with acute myeloid leukemia ineligible for intensive chemotherapy. The multicenter, open-label study randomized patients to receive glasdegib + LDAC (n = 78) or LDAC alone (n = 38). The rate of complete remission (CR) was 19.2% in the glasdegib + LDAC arm versus 2.6% in the LDAC arm (P = 0.015).
METHODS


This post hoc analysis determines whether the clinical benefits of glasdegib are restricted to patients who achieve CR, or if they extend to those who do not achieve CR.
RESULTS


In patients who did not achieve CR, the addition of glasdegib to LDAC improved overall survival (OS) versus LDAC alone (hazard ratio = 0.63 [95% confidence interval, 0.41-0.98]; P = 0.0182; median OS, 5.0 vs 4.1 months). Additionally, more patients receiving glasdegib + LDAC achieved durable recovery of absolute neutrophil count (≥ 1000/μl, 45.6% vs 35.5%), hemoglobin (≥ 9 g/dl, 54.4% vs 38.7%), and platelets (≥ 100,000/μl, 29.8% vs 9.7%). Transfusion independence was achieved by 15.0% and 2.9% of patients receiving glasdegib + LDAC and LDAC alone, respectively.
CONCLUSIONS


Collectively, these data suggest that there are clinical benefits with glasdegib in the absence of CR.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01546038 (March 7, 2012).",2020,"Transfusion independence was achieved by 15.0% and 2.9% of patients receiving glasdegib + LDAC and LDAC alone, respectively.
","['patients with acute myeloid leukemia ineligible for intensive chemotherapy', 'patients with acute myeloid leukemia treated with glasdegib and low-dose']","['LDAC alone', 'cytarabine', 'glasdegib + LDAC', 'glasdegib + low-dose cytarabine (LDAC']","['rate of complete remission (CR', 'durable recovery of absolute neutrophil count', 'hemoglobin', 'Survival outcomes and clinical benefit', 'Transfusion independence', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4519273', 'cui_str': 'glasdegib'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C4519273', 'cui_str': 'glasdegib'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.257089,"Transfusion independence was achieved by 15.0% and 2.9% of patients receiving glasdegib + LDAC and LDAC alone, respectively.
","[{'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Cortes', 'Affiliation': 'Georgia Cancer Center, Augusta, CA, USA. jorge.cortes@augusta.edu.'}, {'ForeName': 'Florian H', 'Initials': 'FH', 'LastName': 'Heidel', 'Affiliation': 'Otto-von-Guericke University Medical Center Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Fiedler', 'Affiliation': 'Department of Hematology and Oncology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'B Douglas', 'Initials': 'BD', 'LastName': 'Smith', 'Affiliation': 'Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.'}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Department of Hematology, Medical University of Łódź and Copernicus Memorial Hospital, Łódź, Poland.'}, {'ForeName': 'Pau', 'Initials': 'P', 'LastName': 'Montesinos', 'Affiliation': 'Hospital Universitari i Politècnic La Fe, Valencia, Spain; CIBERONC, Instituto Carlos III, Madrid, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Candoni', 'Affiliation': 'Azienda Sanitaria Universitaria Integrata di Udine, Udine, Italy.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Leber', 'Affiliation': 'Juravinski Hospital at Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Mikkael A', 'Initials': 'MA', 'LastName': 'Sekeres', 'Affiliation': 'Leukemia Program, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Pollyea', 'Affiliation': 'Division of Hematology, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Ferdinand', 'Affiliation': 'Pfizer Oncology, New York, NY, USA.'}, {'ForeName': 'Weidong Wendy', 'Initials': 'WW', 'LastName': 'Ma', 'Affiliation': 'Pfizer Oncology, New York, NY, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': ""O'Brien"", 'Affiliation': 'Pfizer Oncology, New York, NY, USA.'}, {'ForeName': 'Ashleigh', 'Initials': 'A', 'LastName': ""O'Connell"", 'Affiliation': 'Pfizer Oncology, New York, NY, USA.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Pfizer Oncology, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}]",Journal of hematology & oncology,['10.1186/s13045-020-00929-8']
1565,32663055,Exploring the Impact of Mindfulness on False-Memory Susceptibility.,"Wilson, Mickes, Stolarz-Fantino, Evrard, and Fantino (2015) presented data from three well-powered experiments suggesting that a brief mindfulness induction can increase false-memory susceptibility. However, we had concerns about some of the methodology, including whether mind wandering is the best control condition for brief mindfulness inductions. Here, we report the findings from a preregistered double-blind randomized controlled trial designed to replicate and extend Wilson et al.'s findings. Participants ( N  = 287) underwent 15-min mindfulness or mind-wandering inductions or completed a join-the-dots task before being presented with lists of words related to nonpresented critical lures. This was followed by free-recall and recognition tasks. There was no evidence for an effect of state of mind on correct or false recall or recognition. Furthermore, manipulation checks revealed that mindfulness and mind-wandering inductions activated overlapping states of mind. Exploratory analyses provided some support for mindfulness increasing false memory, but it appears that mind wandering may not be the right control for brief mindfulness research.",2020,There was no evidence for an effect of state of mind on correct or false recall or recognition.,['Participants ( N  = 287) underwent'],['15-min mindfulness or mind-wandering inductions or completed a join-the-dots task before being presented with lists of words related to nonpresented critical lures'],"['false-memory susceptibility', 'False-Memory Susceptibility']","[{'cui': 'C4517682', 'cui_str': '287'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0233569', 'cui_str': 'Wandering'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]","[{'cui': 'C0561845', 'cui_str': 'False memories'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}]",,0.0455014,There was no evidence for an effect of state of mind on correct or false recall or recognition.,"[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Sherman', 'Affiliation': 'School of Psychology, Keele University.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Grange', 'Affiliation': 'School of Psychology, Keele University.'}]",Psychological science,['10.1177/0956797620929302']
1566,32663699,A randomized control trial of activity scheduling for caring for older adults with dementia and its impact on their spouse care-givers.,"INTRODUCTION


Participating in meaningful activities is important for any individual's wellbeing. Activity scheduling enables older adults with dementia and their spouse caregivers to structure their activities in accordance with the things they value.
METHODS


In examining the effectiveness of activity scheduling, this report details the results of a 12-week single-blinded randomized control trial using a parallel group experimental design.
RESULTS


From August 2018 to August 2019, 100 community-dwelling older adults with mild to moderate dementia and their spouses completed this study. The experimental group (n = 50) practicing activity scheduling showed improvements than in control group (n = 50), with respect to alleviating the impact of the caregiving role, reducing the behavioural and psychological symptoms of dementia, decreasing the caring demand and generally improving the quality of life, with Cohen's d = .61, .45, .50 and 43 respectively. Moreover, there were significant differences between the groups indicated that over time, the experimental group showed an improvement with regard to alleviating the role of caring, with Cohen's d = .64, and alleviating disruptive and depressive behavior, with an effect size of .45 and .50 respectively. The number of caring hours needed dropped from 6.98 to 5.98 h in the experimental group.
DISCUSSION & CONCLUSION


There were more activities that older adults with dementia and their spouse caregivers would like to do, and could participate in, than we had expected. Activity scheduling can facilitate their participation. This is a very important topic as non-pharmacological interventions are needed for this even-growing segment of the population.",2020,"The experimental group (n = 50) practicing activity scheduling showed improvements than in control group (n = 50), with respect to alleviating the impact of the caregiving role, reducing the behavioural and psychological symptoms of dementia, decreasing the caring demand and generally improving the quality of life, with Cohen's d = .61, .45, .50 and 43 respectively.","['older adults with dementia and its impact on their spouse care-givers', 'older adults with dementia and their spouse caregivers', 'From August 2018 to August 2019, 100 community-dwelling older adults with mild to moderate dementia and their spouses completed this study']",[],"['number of caring hours needed', 'alleviating disruptive and depressive behavior']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0087015', 'cui_str': 'Spouse Caregivers'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0283988,"The experimental group (n = 50) practicing activity scheduling showed improvements than in control group (n = 50), with respect to alleviating the impact of the caregiving role, reducing the behavioural and psychological symptoms of dementia, decreasing the caring demand and generally improving the quality of life, with Cohen's d = .61, .45, .50 and 43 respectively.","[{'ForeName': 'Frank Ho-Yin', 'Initials': 'FH', 'LastName': 'Lai', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong. Electronic address: frank.hy.lai@polyu.edu.hk.'}, {'ForeName': 'Elaine Wai-Hung', 'Initials': 'EW', 'LastName': 'Yan', 'Affiliation': 'Occupational Therapy Department, Kowloon Hospital, Hong Kong.'}, {'ForeName': 'Wing-Sze', 'Initials': 'WS', 'LastName': 'Tsui', 'Affiliation': ""Chung Hok Elderly Centre, Women's Welfare Club Western District, Hong Kong.""}, {'ForeName': 'Kathy Ka-Ying', 'Initials': 'KK', 'LastName': 'Yu', 'Affiliation': 'Tai Po Integrated Service for Senior Citizens, The Salvation Army Hong Kong & Macau Command, Hong Kong.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104167']
1567,32671719,Cabozantinib for the Treatment of Advanced Hepatocellular Carcinoma: Current Data and Future Perspectives.,"Cabozantinib (Cabometyx ® ) is a potent multikinase inhibitor targeting the vascular endothelial growth factor (VEGF) receptor 2, the mesenchymal-epithelial transition factor (MET) receptor, and the ""anexelekto"" (AXL) receptor tyrosine kinase. It is approved for the treatment of advanced hepatocellular carcinoma (HCC) after failure of sorafenib in Europe (since November 2018) and in the USA (since January 2019). The approval of cabozantinib was based on results of the randomized, placebo-controlled, phase 3 CELESTIAL trial in patients with unresectable HCC, who received one or two prior lines of treatment including sorafenib. At the second planned interim analysis, the trial was stopped, because the primary end point overall survival was clearly in favor for cabozantinib. Additionally, median progression-free survival was superior to placebo. The most common ≥ grade 3 relevant adverse events in patients with HCC treated with cabozantinib were palmar-plantar erythrodysesthesia, hypertension, fatigue, and diarrhea. In this review, current data on cabozantinib for the treatment of patients with advanced HCC, with a focus on the management of common adverse events and ongoing clinical trials, are discussed.",2020,"Additionally, median progression-free survival was superior to placebo.","['patients with advanced HCC', 'Advanced Hepatocellular Carcinoma', 'patients with unresectable HCC, who received one or two prior lines of treatment including', 'advanced hepatocellular carcinoma (HCC) after failure of sorafenib in Europe (since\xa0November 2018) and in the USA (since January 2019']","['Cabozantinib (Cabometyx ® ', 'sorafenib', 'Cabozantinib', 'placebo']","['palmar-plantar erythrodysesthesia, hypertension, fatigue, and diarrhea', 'overall survival', 'median progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C4237933', 'cui_str': 'Cabometyx'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.065429,"Additionally, median progression-free survival was superior to placebo.","[{'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Trojan', 'Affiliation': 'Universitätsklinikum Frankfurt, Medizinische Klinik 1, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany. trojan@em.uni-frankfurt.de.'}]",Drugs,['10.1007/s40265-020-01361-5']
1568,32659247,Children overcoming picky eating (COPE) - A cluster randomised controlled trial.,"OBJECTIVES


Food neophobia limits dietary variety in children and adults. Interventions to alleviate the impact of neophobia on children's dietary variety have had varying success. The potential effectiveness of mindfulness, a process of bringing awareness to the present moment, has received little attention. This trial aimed to explore the effectiveness of two mindfulness exercises on novel food acceptance for children.
METHODS


A cluster-randomised controlled trial with three trial arms compared the impact of two mindfulness exercises (mindful breathing and mindful raisin-eating) and a non-mindful control task on anticipated liking and intake of a novel fruit. Seventy-one children aged 10-12 years engaged in one of the three tasks at school over five days and were offered a novel fruit at the end of the intervention. Children self-reported mindfulness, food neophobia and anxiety at baseline and follow-up.
RESULTS


Two mixed-effects models showed that, controlling for school effects and covariates (including mindfulness, food neophobia and anxiety), children in the mindful raisin-eating arm reported greater anticipated liking of a novel fruit and children in both mindfulness arms consumed greater amounts of a novel fruit than children in the control arm. Mixed-design ANOVAs indicated that mindfulness, food neophobia and anxiety did not change over time in each trial arm.
CONCLUSIONS


The results provide promising evidence for the potential effectiveness of mindfulness interventions in encouraging children to try new foods. The mechanisms underlying effectiveness remain unclear and further research, exploring long-term effects and the possibility to generalise these findings to other food groups such as vegetables, is needed.",2020,"Mixed-design ANOVAs indicated that mindfulness, food neophobia and anxiety did not change over time in each trial arm.
","['children and adults', 'Children overcoming picky eating (COPE) ', 'Seventy-one children aged 10-12 years engaged in one of the three tasks at school over five days and were offered a novel fruit at the end of the intervention', 'children']","['mindfulness exercises (mindful breathing and mindful raisin-eating) and a non-mindful control task', 'mindfulness exercises']","['school effects and covariates (including mindfulness, food neophobia and anxiety', 'mindfulness, food neophobia and anxiety', 'Children self-reported mindfulness, food neophobia and anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0453310', 'cui_str': 'Raisins'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C3840121', 'cui_str': 'Avoidant restrictive food intake disorder'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",71.0,0.0797824,"Mixed-design ANOVAs indicated that mindfulness, food neophobia and anxiety did not change over time in each trial arm.
","[{'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Bennett', 'Affiliation': 'Birmingham and Solihull Mental Health NHS Foundation Trust, UK. Electronic address: carmelbennett@nhs.net.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Copello', 'Affiliation': 'Birmingham and Solihull Mental Health NHS Foundation Trust, UK; School of Psychology, University of Birmingham, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'School of Psychology, University of Birmingham, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Blissett', 'Affiliation': 'Department of Psychology, School of Life and Health Sciences, Aston University, UK.'}]",Appetite,['10.1016/j.appet.2020.104791']
1569,32659482,Transcranial random noise stimulation is more effective than transcranial direct current stimulation for enhancing working memory in healthy individuals: Behavioural and electrophysiological evidence.,"BACKGROUND


Transcranial direct current stimulation (tDCS) has been shown to improve working memory (WM) performance in healthy individuals, however effects tend to be modest and variable. Transcranial random noise stimulation (tRNS) can be delivered with a direct-current offset (DC-offset) to induce equal or even greater effects on cortical excitability than tDCS. To-date, no research has directly compared the effects of these techniques on WM performance or underlying neurophysiological activity.
OBJECTIVE


To compare the effects of anodal tDCS, tRNS + DC-offset, or sham stimulation over the left dorsolateral prefrontal cortex (DLPFC) on WM performance and task-related EEG oscillatory activity in healthy adults.
METHODS


Using a between-subjects design, 49 participants were allocated to receive either anodal tDCS (N = 16), high-frequency tRNS + DC-offset (N = 16), or sham stimulation (N = 17) to the left DLPFC. Changes in WM performance were assessed using the Sternberg WM task completed before and 5- and 25-min post-stimulation. Event-related synchronisation/desynchronisation (ERS/ERD) of oscillatory activity was analysed from EEG recorded during WM encoding and maintenance.
RESULTS


tRNS induced more pronounced and consistent enhancements in WM accuracy when compared to both tDCS and sham stimulation. Improvements in WM performance following tRNS were accompanied by increased theta ERS and diminished gamma ERD during WM encoding, which were significantly greater than those observed following anodal tDCS or sham stimulation.
CONCLUSIONS


These findings demonstrate the potential of tRNS + DC-offset to modulate cognitive and electrophysiological measures of WM and raise the possibility that tRNS + DC-offset may be more effective and reliable than tDCS for enhancing WM performance in healthy individuals.",2020,"Improvements in WM performance following tRNS were accompanied by increased theta ERS and diminished gamma ERD during WM encoding, which were significantly greater than those observed following anodal tDCS or sham stimulation.
","['49 participants', 'healthy individuals', 'healthy adults', 'Healthy Individuals']","['Transcranial direct current stimulation (tDCS', 'high-frequency tRNS + DC-offset (N = 16), or sham stimulation (N = 17) to the left DLPFC', 'anodal tDCS', 'tDCS', 'Transcranial random noise stimulation (tRNS', 'Transcranial Direct Current Stimulation', 'Transcranial Random Noise Stimulation', 'anodal tDCS, tRNS + DC-offset, or sham stimulation']","['WM performance and task-related EEG oscillatory activity', 'Event-related synchronisation/desynchronisation (ERS/ERD) of oscillatory activity', 'Changes in WM performance', 'working memory (WM) performance', 'WM accuracy', 'theta ERS and diminished gamma ERD', 'WM performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C3852967', 'cui_str': 'Transcranial Random Noise Stimulation'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2931783', 'cui_str': 'Enamel-renal syndrome'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]",49.0,0.0357647,"Improvements in WM performance following tRNS were accompanied by increased theta ERS and diminished gamma ERD during WM encoding, which were significantly greater than those observed following anodal tDCS or sham stimulation.
","[{'ForeName': 'O W', 'Initials': 'OW', 'LastName': 'Murphy', 'Affiliation': 'Monash Alfred Psychiatry Research Centre, Central Clinical School, The Alfred and Monash University, Melbourne, Australia; Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Science and Monash Biomedical Imaging, Monash University, Melbourne, Australia; Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, VIC, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: oscar.murphy@monash.edu.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Hoy', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, VIC, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: kate.hoy@monash.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wong', 'Affiliation': 'Monash Institute of Cognitive and Clinical Neurosciences, School of Psychological Science and Monash Biomedical Imaging, Monash University, Melbourne, Australia; School of Psychology and Public Health, La Trobe University, Bundoora, VIC, Australia. Electronic address: d.wong@latrobe.edu.au.'}, {'ForeName': 'N W', 'Initials': 'NW', 'LastName': 'Bailey', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, VIC, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: neil.bailey@monash.edu.'}, {'ForeName': 'P B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare, Camberwell, VIC, Australia; Department of Psychiatry, Central Clinical School, Monash University, Melbourne, VIC, Australia. Electronic address: paul.fitzgerald@monash.edu.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Segrave', 'Affiliation': 'Brain and Mental Health Research Hub, School of Psychological Sciences and Monash Biomedical Imaging, Monash Institute of Cognitive and Clinical Neuroscience, Monash University, Clayton, Australia. Electronic address: rebecca.segrave@monash.edu.'}]",Brain stimulation,['10.1016/j.brs.2020.07.001']
1570,32659483,Non-invasive vagal nerve stimulation decreases brain activity during trauma scripts.,"BACKGROUND


Traumatic stress can have lasting effects on neurobiology and result in psychiatric conditions such as posttraumatic stress disorder (PTSD). We hypothesize that non-invasive cervical vagal nerve stimulation (nVNS) may alleviate trauma symptoms by reducing stress sympathetic reactivity. This study examined how nVNS alters neural responses to personalized traumatic scripts.
METHODS


Nineteen participants who had experienced trauma but did not have the diagnosis of PTSD completed this double-blind sham-controlled study. In three sequential time blocks, personalized traumatic scripts were presented to participants immediately followed by either sham stimulation (n = 8; 0-14 V, 0.2 Hz, pulse width = 5s) or active nVNS (n = 11; 0-30 V, 25 Hz, pulse width = 40 ms). Brain activity during traumatic scripts was assessed using High Resolution Positron Emission Tomography (HR-PET) with radiolabeled water to measure brain blood flow.
RESULTS


Traumatic scripts resulted in significant activations within the bilateral medial and orbital prefrontal cortex, premotor cortex, anterior cingulate, thalamus, insula, hippocampus, right amygdala, and right putamen. Greater activation was observed during sham stimulation compared to nVNS within the bilateral prefrontal and orbitofrontal cortex, premotor cortex, temporal lobe, parahippocampal gyrus, insula, and left anterior cingulate. During the first exposure to the trauma scripts, greater activations were found in the motor cortices and ventral visual stream whereas prefrontal cortex and anterior cingulate activations were more predominant with later script presentations for those subjects receiving sham stimulation.
CONCLUSION


nVNS decreases neural reactivity to an emotional stressor in limbic and other brain areas involved in stress, with changes over repeated exposures suggesting a shift from scene appraisal to cognitively processing the emotional event.",2020,"Greater activation was observed during sham stimulation compared to nVNS within the bilateral prefrontal and orbitofrontal cortex, premotor cortex, temporal lobe, parahippocampal gyrus, insula, and left anterior cingulate.",['Nineteen participants who had experienced trauma but did not have the diagnosis of PTSD completed this double-blind sham-controlled study'],"['invasive cervical vagal nerve stimulation (nVNS', 'active nVNS', 'nVNS']","['bilateral medial and orbital prefrontal cortex, premotor cortex, anterior cingulate, thalamus, insula, hippocampus, right amygdala, and right putamen', 'motor cortices and ventral visual stream whereas prefrontal cortex and anterior cingulate activations', 'Greater activation', 'Brain activity']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0228202', 'cui_str': 'Premotor cortex'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0442540', 'cui_str': 'Stream'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",19.0,0.0708328,"Greater activation was observed during sham stimulation compared to nVNS within the bilateral prefrontal and orbitofrontal cortex, premotor cortex, temporal lobe, parahippocampal gyrus, insula, and left anterior cingulate.","[{'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Wittbrodt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA. Electronic address: mattwittbrodt@emory.edu.'}, {'ForeName': 'Nil Z', 'Initials': 'NZ', 'LastName': 'Gurel', 'Affiliation': 'Department of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'Jonathon A', 'Initials': 'JA', 'LastName': 'Nye', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Ladd', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Md Mobashir H', 'Initials': 'MMH', 'LastName': 'Shandhi', 'Affiliation': 'Department of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'Minxuan', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Amit J', 'Initials': 'AJ', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine (Cardiology), Emory University School of Medicine, Atlanta, GA, USA; Atlanta VA Medical Center, Decatur, GA, USA.'}, {'ForeName': 'Bradley D', 'Initials': 'BD', 'LastName': 'Pearce', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Zuhayr S', 'Initials': 'ZS', 'LastName': 'Alam', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Rapaport', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Murrah', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Yi-An', 'Initials': 'YA', 'LastName': 'Ko', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Ammer A', 'Initials': 'AA', 'LastName': 'Haffer', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Lucy H', 'Initials': 'LH', 'LastName': 'Shallenberger', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Viola', 'Initials': 'V', 'LastName': 'Vaccarino', 'Affiliation': 'Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA; Department of Medicine (Cardiology), Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Omer T', 'Initials': 'OT', 'LastName': 'Inan', 'Affiliation': 'Department of Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA; Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology, Atlanta, GA, USA.'}, {'ForeName': 'J Douglas', 'Initials': 'JD', 'LastName': 'Bremner', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA; Department of Radiology, Emory University School of Medicine, Atlanta, GA, USA; Atlanta VA Medical Center, Decatur, GA, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.07.002']
1571,32659641,A comparative study of autologous rectus fascia pubovaginal sling surgery and synthetic transobturator vaginal tape procedure in treatment of women with urodynamic stress urinary incontinence.,"OBJECTIVE


To compare short term results of autologous rectus fascia pubovaginal sling surgery with synthetic transobturator vaginal tape procedure in treatment of female stress urinary incontinence (SUI) STUDY DESIGN: It was a comparative study on 30 women between 25-65 years of age with urodynamic proven SUI who were randomly allocated to autologous rectus fascia pubovaginal sling surgery (Group I)(15 women) and synthetic transobturator vaginal tape procedure (Group II) (15 women). Preoperative and postoperative ICIQ (International Consultation on Incontinence Questionnaire) score, urodynamic study and serum CRP and IL-6 were done in all cases.
RESULTS


The baseline characteristics in terms of age, body mass index (BMI), parity, mean ICIQ score and mean preoperative CRP and IL-6 levels were similar in two groups. Mean operative time was significantly longer (55.60 ± 5.77 vs 25.27 ± 4.32 minutes, p = 0.001) in group I than group II. Mean hospital stay of 7.1 ± 1.2 vs 1.2 ± 0.4 days, mean duration of catheterization 5.8 vs 1.2 day (<0.01) and postoperative urinary retention requiring recathterization were all significantly higher in group I than II. Wound infection was more in group I than in group II (p = 0.01) while groin pain was significantly more in group II (p = 0.01). One patient developed vesicovaginal fistula, while one patient required cutting of tape in group I. Pdet at Q max (Detrusor pressure at peak urine flow) increased significantly in both the groups after surgery. ICIQ score was zero in both the groups indicating 100 % success. Surgical trauma was more in group I as shown by significantly higher CRP levels.
CONCLUSION


The success rate of the two groups was similar but, autologous rectus fascia sling surgery took longer, had more complications and urinary retention as compared to transobturator vaginal tape procedure.",2020,"Mean operative time was significantly longer (55.60 ± 5.77 vs 25.27 ± 4.32 minutes, p = 0.001) in group I than group II.","['Group II) (15 women', 'women with urodynamic stress urinary incontinence', '30 women between 25-65 years of age with urodynamic proven SUI', 'female stress urinary incontinence']","['autologous rectus fascia pubovaginal sling surgery (Group I)(15 women) and synthetic transobturator vaginal tape procedure', 'autologous rectus fascia pubovaginal sling surgery and synthetic transobturator vaginal tape procedure', 'autologous rectus fascia pubovaginal sling surgery with synthetic transobturator vaginal tape procedure']","['Preoperative and postoperative ICIQ ', 'Mean operative time', 'Mean hospital stay', 'ICIQ score', 'Surgical trauma', 'CRP and IL-6', 'Wound infection', 'postoperative urinary retention requiring recathterization', 'CRP levels', 'complications and urinary retention', 'groin pain', 'vesicovaginal fistula', 'mean duration of catheterization', 'success rate', 'body mass index (BMI), parity, mean ICIQ score and mean preoperative CRP and IL-6 levels', 'Incontinence Questionnaire) score, urodynamic study and serum']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0456369', 'cui_str': 'Proven'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0225234', 'cui_str': 'Structure of fascia of rectus abdominis muscle'}, {'cui': 'C0183346', 'cui_str': 'Sling'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0239783', 'cui_str': 'Inguinal pain'}, {'cui': 'C0042582', 'cui_str': 'Vesicovaginal fistula'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",30.0,0.0224989,"Mean operative time was significantly longer (55.60 ± 5.77 vs 25.27 ± 4.32 minutes, p = 0.001) in group I than group II.","[{'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: jbsharma@aiims.ac.in.'}, {'ForeName': 'Manasi Kamalakar', 'Initials': 'MK', 'LastName': 'Deoghare', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Neerja', 'Initials': 'N', 'LastName': 'Bhatla', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Garima', 'Initials': 'G', 'LastName': 'Kachhawa', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Mahey', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumari', 'Affiliation': 'Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Amlesh', 'Initials': 'A', 'LastName': 'Seth', 'Affiliation': 'Department of Urology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Alpana', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Biochemistry, All India Institute of Medical Sciences, New Delhi, India.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.06.062']
1572,32660530,"Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage for the treatment of patients with moderate to severe intraventricular hemorrhage: a multicenter, randomized, controlled trial.","BACKGROUND


The application of neuroendoscopy in intraventricular hemorrhage (IVH) has attracted more and more attention in recent years. Studies have shown that the use of neuroendoscopy for IVH evacuation has advantages over external ventricular drainage (EVD) alone. However, the cases of most current research are small and all of them are retrospective studies. The aim of this study is to explore the prognosis of patients with moderate to severe IVH who undergo endoscopic IVH evacuation surgery versus those who undergo EVD alone.
METHODS


The study is a prospective, randomized, controlled, multi-center clinical trial. Nine hundred and fifty-six subjects with moderate to severe IVH across four tertiary hospitals in China will be randomly assigned (1:1) to receive either endoscopic IVH evacuation surgery or EVD. The primary objective is to compare patients' survival rate at 12 months after surgery.
DISCUSSION


The trial is designed to investigate the prognostic benefits of endoscopic IVH evacuation surgery for patients with moderate to severe IVH. Currently, it has never been investigated in a prospective randomized controlled clinical trial.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04037267 . Registered on 26 July 2019.",2020,The trial is designed to investigate the prognostic benefits of endoscopic IVH evacuation surgery for patients with moderate to severe IVH.,"['patients with moderate to severe intraventricular hemorrhage', 'patients with moderate to severe IVH who undergo endoscopic IVH evacuation surgery versus those who undergo EVD alone', 'Nine hundred and fifty-six subjects with moderate to severe IVH across four tertiary hospitals in China', 'patients with moderate to severe IVH']","['Endoscopic intraventricular hematoma evacuation surgery versus external ventricular drainage', 'endoscopic IVH evacuation surgery', 'endoscopic IVH evacuation surgery or EVD', 'neuroendoscopy']","[""patients' survival rate""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0948930', 'cui_str': 'Ventricular drainage'}, {'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1261965', 'cui_str': 'Evacuation of hematoma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0948930', 'cui_str': 'Ventricular drainage'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0844266', 'cui_str': 'Neuroendoscopy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",956.0,0.15382,The trial is designed to investigate the prognostic benefits of endoscopic IVH evacuation surgery for patients with moderate to severe IVH.,"[{'ForeName': 'Junhao', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Jinling Hospital, School of Medicine, Nanjing Medical University, 104 Hanzhong Road, Nanjing, 210002, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Neurosurgery, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, 210002, China.'}, {'ForeName': 'Zixiang', 'Initials': 'Z', 'LastName': 'Cong', 'Affiliation': 'Department of Neurosurgery, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, 210002, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Jinling Hospital, School of Medicine, Nanjing Medical University, 104 Hanzhong Road, Nanjing, 210002, China.'}, {'ForeName': 'Xiangming', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'School of Medicine, Southeast University, Nanjing, 210009, China.'}, {'ForeName': 'Yuxiu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Statistics, Jinling Hospital, Nanjing Medical University, Nanjing, 210002, China. liu_yuxiu@163.com.'}, {'ForeName': 'Chiyuan', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Jinling Hospital, School of Medicine, Nanjing Medical University, 104 Hanzhong Road, Nanjing, 210002, China. machiyuan_nju@126.com.'}]",Trials,['10.1186/s13063-020-04560-3']
1573,32661006,A Randomized Clinical Trial of the Efficacy and Safety of Interferon β-1a in Treatment of Severe COVID-19.,"To the best of our knowledge, there is no published study on the use of interferon β-1a (IFN β-1a) in the treatment of severe COVID-19. In this randomized clinical trial, the efficacy and safety of IFN β-1a were evaluated in patients with severe COVID-19. Forty-two patients in the interferon group received IFN β-1a in addition to the national protocol medications (hydroxychloroquine plus lopinavir-ritonavir or atazanavir-ritonavir). Each 44-μg/ml (12 million IU/ml) dose of interferon β-1a was subcutaneously injected three times weekly for two consecutive weeks. The control group consisted of 39 patients who received only the national protocol medications. The primary outcome of the study was time to reach clinical response. Secondary outcomes were duration of hospital stay, length of intensive care unit stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects, and complications during the hospitalization. Between 29 February and 3 April 2020, 92 patients were recruited, and a total of 42 patients in the IFN group and 39 patients in the control group completed the study. As the primary outcome, time to the clinical response was not significantly different between the IFN and the control groups (9.7 ± 5.8 versus 8.3 ± 4.9 days, respectively,  P  = 0.95). On day 14, 66.7% versus 43.6% of patients in the IFN group and the control group, respectively, were discharged (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.05 to 6.37). The 28-day overall mortality was significantly lower in the IFN than the control group (19% versus 43.6%, respectively,  P  = 0.015). Early administration significantly reduced mortality (OR, 13.5; 95% CI, 1.5 to 118). Although IFN did not change the time to reach the clinical response, adding it to the national protocol significantly increased discharge rate on day 14 and decreased 28-day mortality. (This study is in the Iranian Registry of Clinical Trials under identifier IRCT20100228003449N28.).",2020,"Early administration significantly reduced mortality (OR=13.5; 95% CI: 1.5-118).
","['Forty-two patients in the interferon group received IFN β-1a in addition to the national protocol medications ', 'severe COVID-19', 'Between 29 th  February to 3 rd  April 2020, 92 patients were recruited that finally 42 patients in the IFN group and 39 patients in the control group completed the study', 'patients with severe COVID-19']","['hydroxychloroquine plus lopinavir/ritonavir or atazanavir/ritonavir', 'IFN β-1a', 'IFN', 'interferon β-1a']","['reduced mortality', 'time to the clinical response', 'Efficacy and safety', 'duration of hospital stay, length of ICU stay, 28-day mortality, effect of early or late administration of IFN on mortality, adverse effects and complications during the hospitalization', 'time to reach clinical response', '28-day mortality', 'discharge rate', '28-day overall mortality']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C1145759', 'cui_str': 'Atazanavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",92.0,0.186626,"Early administration significantly reduced mortality (OR=13.5; 95% CI: 1.5-118).
","[{'ForeName': 'Effat', 'Initials': 'E', 'LastName': 'Davoudi-Monfared', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rahmani', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khalili', 'Affiliation': 'Department of Pharmacotherapy, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran Khalilih@sina.tums.ac.ir.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Hajiabdolbaghi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohamadreza', 'Initials': 'M', 'LastName': 'Salehi', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Abbasian', 'Affiliation': 'Department of Infectious Diseases, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Kazemzadeh', 'Affiliation': 'Advanced Thoracic Research Center, Occupational Sleep Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mir Saeed', 'Initials': 'MS', 'LastName': 'Yekaninejad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01061-20']
1574,32662092,Effect of dipeptidyl peptidase-4 inhibitors on complement activation.,"BACKGROUND


Adverse activation of the complement cascade in the innate immune system appears to be involved in development of vascular complications in diabetes. Dipeptidyl peptidase-4 (DPP-4) is a cell surface serine protease expressed in a variety of tissues. DPP-4 inhibitors are widely used in treatment of type 2 diabetes and appear to yield beneficial pleiotropic effects beyond their glucose-lowering action, for example, renoprotective and anti-inflammatory properties, but the exact mechanisms remain unknown. We hypothesised that DPP-4 inhibitors block adverse complement activation by inhibiting complement-activating serine proteases.
MATERIALS AND METHODS


We analysed the effects of 7 different DPP-4 inhibitors on the lectin and classical pathway of the complement system in vitro by quantifying complement factor C4b deposition onto mannan or IgG coated surfaces, respectively. Furthermore, plasma concentrations of mannan-binding lectin (MBL), soluble membrane attack complex (sMAC), and C4b deposition were quantified in 71 patients with a recent acute coronary syndrome and glucose disturbances, randomly assigned to sitagliptin 100 mg (n = 34) or placebo (n = 37) for 12 weeks.
RESULTS


All the 7 DPP-4 inhibitors tested in the study directly inhibited functional activity of the lectin pathway in a dose-dependent manner with varying potency in vitro. In vivo, MBL, sMAC, and C4b declined significantly during follow-up in both groups without significant effect of sitagliptin.
CONCLUSIONS


We demonstrated an inhibitory effect of DPP-4 inhibitors on the lectin pathway in vitro. The clinical relevance of this effect of DPP-4 inhibitors remains to be fully elucidated.",2020,"Furthermore, plasma concentrations of mannan-binding lectin (MBL), soluble membrane attack complex (sMAC), and C4b deposition were quantified in 71 patients with a recent acute coronary syndrome and glucose disturbances, randomly assigned to sitagliptin 100 mg (n=34) or placebo (n=37) for 12 weeks.
","['diabetes', '71 patients with a recent acute coronary syndrome and glucose disturbances']","['DPP-4 inhibitors', 'Dipeptidyl peptidase-4 (DPP-4', 'placebo', 'dipeptidyl peptidase-4 inhibitors']","['Furthermore, plasma concentrations of mannan-binding lectin (MBL), soluble membrane attack complex (sMAC), and C4b deposition', 'MBL, sMAC, and C4b']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]","[{'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0081937', 'cui_str': 'Dipeptidyl peptidase IV'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0065661', 'cui_str': 'Mannose-binding protein'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0333562', 'cui_str': 'Deposition'}]",71.0,0.0519561,"Furthermore, plasma concentrations of mannan-binding lectin (MBL), soluble membrane attack complex (sMAC), and C4b deposition were quantified in 71 patients with a recent acute coronary syndrome and glucose disturbances, randomly assigned to sitagliptin 100 mg (n=34) or placebo (n=37) for 12 weeks.
","[{'ForeName': 'Ingeborg T', 'Initials': 'IT', 'LastName': 'Hoffmann-Petersen', 'Affiliation': 'Department of Internal Medicine, Regional Hospital of Northern Jutland, Hjørring, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'B Holt', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Jensen', 'Affiliation': 'Department of Biomedicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Hage', 'Affiliation': 'Cardiology Unit, Department of Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'G Mellbin', 'Affiliation': 'Cardiology Unit, Department of Medicine, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Thiel', 'Affiliation': 'Department of Biomedicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Troels K', 'Initials': 'TK', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'A Østergaard', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3385']
1575,32663640,"A commentary on ""Effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery: A randomized controlled trial"" (Int J Surg 2020;80:13-18).",,2020,,['Elderly Patients undergoing Hip Joint Replacement Surgery'],['Edaravone'],['Postoperative Cognitive Function'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",,0.104829,,"[{'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Woo', 'Affiliation': 'School of Medicine, Cardiff University, University Hospital of Wales, Heath Park, Cardiff, CF14 4XN, United Kingdom. Electronic address: wootk@cardiff.ac.uk.'}, {'ForeName': 'Sashiananthan', 'Initials': 'S', 'LastName': 'Ganesananthan', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, United Kingdom.'}, {'ForeName': 'ChunHei', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, United Kingdom.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.07.001']
1576,32671930,Authors' reply re: Incidence and characteristics of pregnancy-related death across ten low- and middle-income geographical regions: secondary analysis of a cluster randomised controlled trial: The underestimated incidence of eclampsia in low-income countries: variation between regions.,,2020,,[],[],['Incidence and characteristics of pregnancy-related death'],[],[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.326366,,"[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Vousden', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16353']
1577,32687836,Failure of tDCS to modulate motor excitability and speech motor learning.,"Transcranial direct current stimulation (tDCS) modulates cortical excitability in a polarity-specific way and, when used in combination with a behavioural task, it can alter performance. TDCS has the potential, therefore, for use as an adjunct to therapies designed to treat disorders affecting speech, including, but not limited to acquired aphasias and developmental stuttering. For this reason, it is important to conduct studies evaluating its effectiveness and the parameters optimal for stimulation. Here, we aimed to evaluate the effects of bi-hemispheric tDCS over speech motor cortex on performance of a complex speech motor learning task, namely the repetition of tongue twisters. A previous study in older participants showed that tDCS could modulate performance on a similar task. To further understand the effects of tDCS, we also measured the excitability of the speech motor cortex before and after stimulation. Three groups of 20 healthy young controls received: (i) anodal tDCS to the left IFG/LipM1 and cathodal tDCS to the right hemisphere homologue; or (ii) cathodal tDCS over the left and anodal over the right; or (iii) sham stimulation. Participants heard and repeated novel tongue twisters and matched simple sentences before, during and 10 min after the stimulation. One mA tDCS was delivered concurrent with task performance for 13 min. Motor excitability was measured using transcranial magnetic stimulation to elicit motor-evoked potentials in the lip before and immediately after tDCS. The study was double-blind, randomized, and sham-controlled; the design and analysis were pre-registered. Performance on the task improved from baseline to after stimulation but was not significantly modulated by tDCS. Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and was unrelated to task performance. Bayesian analyses provide substantial evidence in support of the null hypotheses in both cases, namely that tongue twister performance and motor excitability were not affected by tDCS. We discuss our findings in the context of the previous positive results for a similar task. We conclude that tDCS may be most effective when brain function is sub-optimal due to age-related declines or pathology. Further study is required to determine why tDCS failed to modulate excitability in the speech motor cortex in the expected ways.",2020,"Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and were unrelated to task performance.","['older participants', '20 healthy young controls received: (i']","['bi-hemispheric tDCS', 'Transcranial direct current stimulation (tDCS', 'TDCS', 'tDCS', 'anodal tDCS to the left IFG/LipM1 and cathodal tDCS to the right hemisphere homologue; or (ii) cathodal tDCS over the left and anodal over the right; or (iii) sham stimulation']","['tongue twister performance and motor excitability', 'motor excitability', 'Motor excitability']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0546911', 'cui_str': 'To the right'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0335670', 'cui_str': 'Twister'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",20.0,0.046913,"Similarly, a small decrease in motor excitability was seen in all three stimulation groups but did not differ among them and were unrelated to task performance.","[{'ForeName': 'Charlotte E E', 'Initials': 'CEE', 'LastName': 'Wiltshire', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, Radcliffe Observatory Quarter, University of Oxford, OX2 6GG, UK. Electronic address: charlotte.wiltshire@psy.ox.ac.uk.'}, {'ForeName': 'Kate E', 'Initials': 'KE', 'LastName': 'Watkins', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, Department of Experimental Psychology, Radcliffe Observatory Quarter, University of Oxford, OX2 6GG, UK. Electronic address: kate.watkins@psy.ox.ac.uk.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2020.107568']
1578,32678082,Vagus nerve stimulation boosts the drive to work for rewards.,"Interoceptive feedback transmitted via the vagus nerve plays a vital role in motivation by tuning actions according to physiological needs. Whereas vagus nerve stimulation (VNS) reinforces actions in animals, motivational effects elicited by VNS in humans are still largely elusive. Here, we applied non-invasive transcutaneous auricular VNS (taVNS) on the left or right ear while participants exerted effort to earn rewards using a randomized cross-over design (vs. sham). In line with preclinical studies, acute taVNS enhances invigoration of effort, and stimulation on the left side primarily facilitates invigoration for food rewards. In contrast, we do not find conclusive evidence that acute taVNS affects effort maintenance or wanting ratings. Collectively, our results suggest that taVNS enhances reward-seeking by boosting invigoration, not effort maintenance and that the stimulation side affects generalization beyond food reward. Thus, taVNS may enhance the pursuit of prospective rewards which may pave avenues to treat motivational deficiencies.",2020,"In line with preclinical studies, acute taVNS enhances invigoration of effort, and stimulation on the left side primarily facilitates invigoration for food rewards.",[],"['vagus nerve stimulation (VNS', 'invasive transcutaneous auricular VNS (taVNS']",[],[],"[{'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}]",[],,0.0294214,"In line with preclinical studies, acute taVNS enhances invigoration of effort, and stimulation on the left side primarily facilitates invigoration for food rewards.","[{'ForeName': 'Monja P', 'Initials': 'MP', 'LastName': 'Neuser', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Teckentrup', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kühnel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Hallschmid', 'Affiliation': 'Department of Medical Psychology and Behavioral Neurobiology, University of Tübingen, Otfried-Müller-Straße 25, 72076, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany.'}, {'ForeName': 'Nils B', 'Initials': 'NB', 'LastName': 'Kroemer', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Calwerstraße 14, 72076, Tübingen, Germany. nils.kroemer@uni-tuebingen.de.'}]",Nature communications,['10.1038/s41467-020-17344-9']
1579,32674009,Extracorporeal shockwave therapy in the management of plantar fasciitis: A randomized controlled trial.,"BACKGROUND


This study aimed at estimating the extent to which a combination therapy of extracorporeal shockwave therapy (ESWT) with usual care (exercise and orthotic support) improve functional ability in the patient with plantar fasciitis when compared to usual care alone.
METHODS


Participants with plantar fasciitis were randomly allocated into two groups: ESWT (n=23), and control (n=21). All participants received home exercise program with orthotic support. In addition, ESWT group received 2000 shock waves with 0.02 mJ/mm 2  for three sessions. Functional outcomes were measured by function subscale of American orthopedic foot and ankle society (AOFAS-F) score and 12 minutes walking test including walking speed, cadence. The scores were recorded at baseline, third week and third month after the treatment. Analysis was performed using repeated measures ANOVA, and an intention to treat approach using multiple imputations.
RESULTS


Results showed that there was a significant improvement in AOFAS-F total score and walking speed over three months in both groups (p<0.001, p=0.04 respectively); improvements in AOFAS-F were particularly in activity limitation (p=0.001), walking distance (p=0.02) and walking surface (p=0.02). Groups were comparable with each other for both walking speed and AOFAS-F in any assessment time (p>0.05). However, groups performed differently in cadence where there was an increase in cadence in ESWT group whereas a decline in control at the third month (p=0.07).
CONCLUSION


The results revealed that ESWT did not have an additive benefit over usual care to improve foot function and walking performance in patient with plantar fasciitis over three months post-treatment.",2020,Groups were comparable with each other for both walking speed and AOFAS-F in any assessment time (p>0.05).,"['Participants with plantar fasciitis', 'plantar fasciitis', 'patient with plantar fasciitis']","['ESWT', 'extracorporeal shockwave therapy (ESWT) with usual care (exercise and orthotic support', 'Extracorporeal shockwave therapy', 'home exercise program with orthotic support']","['foot function and walking performance', 'walking surface', 'AOFAS-F total score and walking speed', 'AOFAS-F', 'function subscale of American orthopedic foot and ankle society (AOFAS-F) score and 12 minutes walking test including walking speed, cadence', 'cadence', 'walking distance', 'activity limitation', 'functional ability']","[{'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0029365', 'cui_str': 'Orthotic device'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0430516', 'cui_str': '12-minute walk test'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",,0.0431827,Groups were comparable with each other for both walking speed and AOFAS-F in any assessment time (p>0.05).,"[{'ForeName': 'Eda', 'Initials': 'E', 'LastName': 'Cinar', 'Affiliation': 'School of Physical and Occupational Therapy, McGill University, 8852 Saint Hubert, Montreal, QC, H2M 1Y5, Canada. Electronic address: edaccinar@gmail.com.'}, {'ForeName': 'Shikha', 'Initials': 'S', 'LastName': 'Saxena', 'Affiliation': 'School of Physical and Occupational Therapy, McGill University, 8852 Saint Hubert, Montreal, QC, H2M 1Y5, Canada. Electronic address: shikha.saxena@mail.mcgill.ca.'}, {'ForeName': 'Halil Ekrem', 'Initials': 'HE', 'LastName': 'Akkurt', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Konya Training and Research Hospital, Konya Eğitim ve Araştırma Hastanesi Fiziksel Tıp ve Rehabilitasyon Kliniği, Meram, Konya, 42090, Turkey. Electronic address: ekremakkurt@yahoo.com.'}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Uygur', 'Affiliation': 'Department of Physical Therapy and Rehabilitation, Faculty of Health Science Cyprus International University, via Mersin 10, 99258 Lefkoşa, Turkey. Electronic address: fztuygur@yahoo.com.'}]","Foot (Edinburgh, Scotland)",['10.1016/j.foot.2020.101679']
1580,32674048,"Cyclosporine or methotrexate, which one is more promising in the treatment of lichen planopilaris?; A comparative clinical trial.","BACKGROUND


Lichen Planopilaris (LPP) is a primary scarring alopecia with unknown etiology and its management is a challenge for dermatologists. We aimed to compare the safety and efficacy of methotrexate and cyclosporine in LPP patients.
METHODS


In a randomized clinical trials, 33 patients were randomly allocated to receive either 15-mg oral methotrexate per week or 3-5-mg/kg/day cyclosporine for six months. During the treatment course, side effects, signs/symptoms and laboratory test were assessed periodically. Lichen planopilaris activity index (LPPAI) was measured at baseline and 2, 4, and 6 months after the intervention. Score of both photography and patient's opinion were also obtained. The collected data were analyzed in SPSS software (Ver.25.0. Armonk, NY: IBM Corp).
RESULTS


Both medications had positive effects on the signs and symptoms of LPP with a significant difference between the variables (p < 0.05), and the results showed similar efficacy at the end of 6th months of the therapy with both cyclosporine and methotrexate (p > 0.05).
CONCLUSIONS


Regarding the results of the present study, both cyclosporine and methotrexate are effective in treating refractory lichen planopilaris and we propose methotrexate as a possible earlier choice over cyclosporine. This study was registered in Iranian Registry of Clinical Trials (IRCT20190717044256N1).",2020,"Both medications had positive effects on the signs and symptoms of LPP with a significant difference between the variables (p < 0.05), and the results showed similar efficacy at the end of 6th months of the therapy with both cyclosporine and methotrexate (p > 0.05).
","['LPP patients', '33 patients']","['Lichen Planopilaris (LPP', 'cyclosporine and methotrexate', '15-mg oral methotrexate per week or 3-5-mg/kg/day cyclosporine', 'Cyclosporine or methotrexate', 'methotrexate and cyclosporine', 'cyclosporine']","['side effects, signs/symptoms and laboratory test', 'safety and efficacy', 'Lichen planopilaris activity index (LPPAI', 'signs and symptoms of LPP']","[{'cui': 'C0023645', 'cui_str': 'Lichen planopilaris'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023645', 'cui_str': 'Lichen planopilaris'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0023645', 'cui_str': 'Lichen planopilaris'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",33.0,0.113439,"Both medications had positive effects on the signs and symptoms of LPP with a significant difference between the variables (p < 0.05), and the results showed similar efficacy at the end of 6th months of the therapy with both cyclosporine and methotrexate (p > 0.05).
","[{'ForeName': 'Farahnaz', 'Initials': 'F', 'LastName': 'Fatemi Naeini', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: fatemi@med.mui.ac.ir.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mohaghegh', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: f.mohaghegh@med.mui.ac.ir.'}, {'ForeName': 'Minoo', 'Initials': 'M', 'LastName': 'Jelvan', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: minoo.jelvan@gmail.com.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Asilian', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: asilian@med.mui.ac.ir.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Saber', 'Affiliation': 'Skin Diseases and Leishmaniasis Research Center, Department of Dermatology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: mi.saber@med.mui.ac.ir.'}]",International immunopharmacology,['10.1016/j.intimp.2020.106765']
1581,32673213,Barriers and Facilitators for Referrals of Primary Care Patients to Blended Internet-Based Psychotherapy for Depression: Mixed Methods Study of General Practitioners' Views.,"BACKGROUND


Major depressive disorder (MDD) is highly prevalent and often managed by general practitioners (GPs). GPs mostly prescribe medication and show low referral rates to psychotherapy. Many patients remain untreated. Blended psychotherapy (bPT) combines internet-based interventions with face-to-face psychotherapy and could increase treatment access and availability. Effectively implementing bPT in routine care requires an understanding of professional users' perspectives and behavior.
OBJECTIVE


This study aims to identify barriers and facilitators perceived by GPs in referring patients to bPT. Explanations for variations in referral rates were examined.
METHODS


Semistructured interviews were conducted with 12 of 110 GPs participating in a German randomized controlled trial (RCT) to investigate barriers to and facilitators for referrals to bPT for MDD (10 web-based modules, app-based assessments, and 6 face-to-face sessions). The interview guide was based on the theoretical domains framework. The interviews were audio recorded and transcribed verbatim, and the qualitative content was analyzed by 2 independent coders (intercoder agreement, k=0.71). A follow-up survey with 12 interviewed GPs enabled the validation of emergent themes. The differences in the barriers and facilitators identified between groups with different characteristics (eg, GPs with high or low referral rates) were described. Correlations between referrals and characteristics, self-rated competences, and experiences managing depression of the RCT-GPs (n=76) were conducted.
RESULTS


GPs referred few patients to bPT, although varied in their referral rates, and interviewees referred more than twice as many patients as RCT-GPs (interview-GPs: mean 6.34, SD 9.42; RCT-GPs: mean 2.65, SD 3.92). A negative correlation was found between GPs' referrals and their self-rated pharmacotherapeutic competence, r(73)=-0.31, P<.001. The qualitative findings revealed a total of 19 barriers (B) and 29 facilitators (F), at the levels of GP (B=4 and F=11), patient (B=11 and F=9), GP practice (B=1 and F=3), and sociopolitical circumstances (B=3 and F=6). Key barriers stated by all interviewed GPs included ""little knowledge about internet-based interventions"" and ""patients' lack of familiarity with technology/internet/media"" (number of statements, each k=22). Key facilitators were ""perceived patient suitability, e.g. well-educated, young"" (k=22) and ""no conflict with GP's role"" (k=16). The follow-up survey showed a very high agreement rate of at least 75% for 71% (34/48) of the identified themes. Descriptive findings indicated differences between GPs with low and high referral rates in terms of which and how many barriers (low: mean 9.75, SD 1.83; high: mean 10.50, SD 2.38) and facilitators (low: mean 18.25, SD 4.13; high: mean 21.00; SD 3.92) they mentioned.
CONCLUSIONS


This study provides insights into factors influencing GPs' referrals to bPT as gatekeepers to depression care. Barriers and facilitators should be considered when designing implementation strategies to enhance referral rates. The findings should be interpreted with care because of the small and self-selected sample and low response rates.",2020,"A negative correlation was found between GPs' referrals and their self-rated pharmacotherapeutic competence, r(73)=-.31, P<.01.",['Qualitative approach: Semi-structured interviews with 12 of 110 GPs participating in a German randomized-controlled trial (E-COMPARED'],"['blended internet-based psychotherapy', 'Blended Psychotherapy (bPT', 'Quantitative approach']",[],"[{'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",[],76.0,0.0501087,"A negative correlation was found between GPs' referrals and their self-rated pharmacotherapeutic competence, r(73)=-.31, P<.01.","[{'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Titzler', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Berking', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Schlicker', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Riper', 'Affiliation': 'Faculty of Behavioral and Movement Sciences, Section of Clinical Psychology, VU University Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Erlangen-Nürnberg, Erlangen, Germany.'}]",JMIR mental health,['10.2196/18642']
1582,32679434,"Diet-induced differences in estimated plasma glucose concentrations in healthy, non-diabetic adults are detected by continuous glucose monitoring-a randomized crossover trial.","Continuous glucose monitors (CGMs) have been developed for diabetic patients for estimating and controlling plasma glucose changes throughout the day. However, elevated postprandial glucose concentrations may also be detrimental for non-diabetic subjects by increasing the risk of developing vascular complications and type 2 diabetes. Therefore, CGMs may also be valuable in clinical research and we hypothesized that diet-induced differences in estimated plasma glucose concentrations in healthy, non-diabetic adults could be detected by the Abbott FreeStyle Libre Pro CGM. In this single-blind randomized cross-over trial, 23 healthy but overweight or obese men and women therefore consumed two diets differing in glycemic load in randomized order for three consecutive days. Based on the CGM measurements, two-hour total areas under the curve (tAUCs) after breakfast, lunch and dinner were calculated. Additionally, postprandial glucose was measured with the CGM and in plasma during a rice meal challenge. The average tAUC was significantly lower on the low GL diet compared to the high GL diet (P < .0001). The same conclusions were drawn when tAUCs for breakfast (P < .0001), lunch (P < .0001) and dinner (P < .0001) were analyzed separately. During the rice meal challenge, significantly higher glucose responses were observed after the low GL period, as monitored by both the CGM device (P < .0001) and the plasma glucose analysis (P < .0001). The difference between the means of both methods was 0.11 mmol/L (1.78%) with a higher glucose value in plasma. The absolute mean difference was 0.66 mmol/L (10.5%). We conclude that the CGM detected diet-induced differences in estimated plasma glucose concentrations, which supports its use not only in clinical practice, but also for research purposes during dietary interventions in non-diabetic participants.",2020,The average tAUC was significantly lower on the low GL diet compared to the high GL diet (P < .0001).,"['healthy, non-diabetic adults', '23 healthy but overweight or obese men and women', 'non-diabetic participants', 'diabetic patients']",['Continuous glucose monitors (CGMs'],"['elevated postprandial glucose concentrations', 'average tAUC', 'glucose responses', 'plasma glucose analysis', 'plasma glucose concentrations', 'postprandial glucose']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C2584434', 'cui_str': 'Plasma glucose concentration'}]",23.0,0.0315526,The average tAUC was significantly lower on the low GL diet compared to the high GL diet (P < .0001).,"[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Fechner', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, PO Box 616, 6200, MD, Maastricht, The Netherlands. Electronic address: eva.fechner@outlook.com.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': ""Op 't Eyndt"", 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, PO Box 616, 6200, MD, Maastricht, The Netherlands. Electronic address: cara.opteyndt@mumc.nl.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Mulder', 'Affiliation': 'Unilever Foods Innovation Center - Hive, Bronland 14, 6708, WH, Wageningen, The Netherlands. Electronic address: theo.mulder@unilever.com.'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Mensink', 'Affiliation': 'Department of Nutrition and Movement Sciences, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center+, PO Box 616, 6200, MD, Maastricht, The Netherlands. Electronic address: r.mensink@maastrichtuniversity.nl.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.06.001']
1583,32679537,Blood pressure postpartum (BP 2 ) RCT protocol: Follow-up and lifestyle behaviour change strategies in the first 12 months after hypertensive pregnancy.,"OBJECTIVES


Women who had hypertensive disorders of pregnancy (HDP) are twice as likely to experience maternal cardiovascular disease later in life. The primary aim of this study (BP 2 ) is to compare outcomes of 3 different management strategies, including lifestyle behaviour change (LBC), in the first 12 months postpartum in women who had HDP in their preceding pregnancy. Secondary aims include assessing the effects on other cardiometabolic parameters.
STUDY DESIGN


Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480. Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2) Brief intervention: information package as per group 1, plus assessment and brief LBC counselling at a specialised clinic with an obstetric physician and dietitian 6 months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6 month telephone-based LBC program from 6 to 12 months postpartum. All women have an outcome assessment at 12 months.
MAIN OUTCOME MEASURES


Primary outcomes: (a) BP change or (b) weight change and/or waist circumference change.
SECONDARY OUTCOMES


maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios. The study is powered to detect a 4 mmHg difference in systolic BP between groups, or a 4 kg weight loss difference/2cm waist circumference change.
CONCLUSIONS


BP 2  will provide evidence regarding the feasibility and effectiveness of postpartum LBC interventions and structured clinical follow-up in improving cardiovascular health markers after HDP.",2020,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"['women who had HDP in their preceding pregnancy', 'Three-arm multicentre randomised trial in metropolitan Australian hospitals, (registration: ACTRN12618002004246) target sample size 480', 'Women who had hypertensive disorders of pregnancy (HDP']","['LBC counselling at a specialised clinic with an obstetric physician and dietitian 6\xa0months postpartum 3) Extended intervention: as per group 2 plus enrolment into a 6\xa0month telephone-based LBC program', 'Optimised usual care: information package and family doctor follow-up 6\xa0months postpartum 2']","['Blood pressure postpartum (BP 2 ', 'BP change or (b) weight change and/or waist circumference change', 'maternal health-related quality of life, engagement and retention in LBC program, biochemical markers, vascular function testing, infant weight trajectory, incremental cost-effectiveness ratios', 'systolic BP', 'lifestyle behaviour change (LBC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0852260', 'cui_str': 'Hypertension associated disorders of pregnancy'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C4319609', 'cui_str': '480'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1704221', 'cui_str': 'Family medicine specialist'}, {'cui': 'C0589124', 'cui_str': 'Follow-up 6 months'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1268766', 'cui_str': 'Blood pressure alteration'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4704805', 'cui_str': 'Weight Trajectory'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",480.0,0.118249,Participants are randomised to one of three groups: 1) Optimised usual care: information package and family doctor follow-up 6 months postpartum 2),"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Henry', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; The George Institute for Global Health, Sydney, Australia. Electronic address: Amanda.Henry@unsw.edu.au.""}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, Sydney, Australia; Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Faculty of Medicine, University of New South Wales, Sydney, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Makris', 'Affiliation': 'Faculty of Medicine, University of New South Wales, Sydney, Australia; School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Hennessy', 'Affiliation': 'School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Beech', 'Affiliation': 'Royal Hospital for Women, Randwick, New South Wales, Australia.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Pettit', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Se Homer', 'Affiliation': 'Burnet Institute, Melbourne, Victoria, Australia; Faculty of Health, University of Technology, Sydney, New South Wales, Australia.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Craig', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.""}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hyett', 'Affiliation': 'Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia; Sydney Medical School, University of Sydney, Australia.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Chambers', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Oisin', 'Initials': 'O', 'LastName': 'Fitzgerald', 'Affiliation': ""National Perinatal Epidemiology and Statistics Unit, School of Women's and Children's Health and Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW, Australia.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Gow', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mann', 'Affiliation': 'General Practitioner, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Challis', 'Affiliation': ""School of Women's and Children's Health, UNSW Medicine, University of New South Wales, Sydney, Australia; Royal Hospital for Women, Randwick, New South Wales, Australia.""}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Gale', 'Affiliation': 'New South Wales Ministry of Health, North Sydney, New South Wales, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Ruhotas', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Emilee', 'Initials': 'E', 'LastName': 'Kirwin', 'Affiliation': ""Women's and Children's Health, St George Hospital, Kogarah, New South Wales, Australia.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Denney-Wilson', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brown', 'Affiliation': 'Department of Renal Medicine, St George Hospital, Kogarah, New South Wales, Australia; St George and Sutherland Clinical School, UNSW Medicine, University of New South Wales, Sydney, Australia.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.001']
1584,32692299,Two-year Review on Mortality and Morbidity after Femoropopliteal Drug-coated Balloon Angioplasty in the Randomized EffPac Trial.,,2020,,[],['Femoropopliteal Drug-coated Balloon Angioplasty'],['Mortality and Morbidity'],[],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.0892218,,"[{'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Teichgräber', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); REGIOMED Clinics, Sonneberg, Germany (M.T.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); and Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehmann', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); REGIOMED Clinics, Sonneberg, Germany (M.T.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); and Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.).'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Aschenbach', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); REGIOMED Clinics, Sonneberg, Germany (M.T.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); and Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.).'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Thieme', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); REGIOMED Clinics, Sonneberg, Germany (M.T.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); and Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); REGIOMED Clinics, Sonneberg, Germany (M.T.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); and Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.).'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Beschorner', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); REGIOMED Clinics, Sonneberg, Germany (M.T.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); and Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.).'}, {'ForeName': 'Dierk', 'Initials': 'D', 'LastName': 'Scheinert', 'Affiliation': 'From the Department of Radiology, Jena University Hospital, Am Klinikum 1, 07747 Jena, Germany (U.T., R.A.); Center for Clinical Studies, Jena University Hospital, Jena, Germany (T.L.); REGIOMED Clinics, Sonneberg, Germany (M.T.); Heart Center Bad Krozingen, Bad Krozingen, Germany (T.Z., U.B.); and Department of Angiology, University Hospital Leipzig, Leipzig, Germany (D.S.).'}]",Radiology,['10.1148/radiol.2020201370']
1585,32699919,ACL reconstruction using a quadruple semitendinosus graft with cortical fixations gives suitable isokinetic and clinical outcomes after 2 years.,"PURPOSE


The objective of this single-center randomized single-blinded trial was to assess the hypothesis that anterior cruciate ligament reconstruction (ACLR) using a four-strand semitendinosus (ST) graft with adjustable femoral and tibial cortical fixation produced good outcomes compared to an ST/gracilis (ST/G) graft with femoral pin transfixation and tibial bioscrew fixation. Follow-up was 2 years.
METHODS


Patients older than 16 years who underwent primary isolated ACLR included for 1 year until August 2017 were eligible. The primary outcome measures were the subjective International Knee Documentation Committee (IKDC) score, isokinetic muscle strength recovery, and return to work within 2 years. The study was approved by the ethics committee.
RESULTS


Of 66 eligible patients, 60 completed the study and were included, 33 in the 4ST group and 27 in the ST/G group. Mean age was 30.5 ± 8.9 years in the 4ST group and 30.3 ± 8.5 in the ST/G group (n.s.). No significant between-group differences were found for mean postoperative subjective IKDC (4ST group, 80.2 ± 12.5; ST/G group, 83.6 ± 13.6; n.s.), side-to-side percentage deficits in isokinetic hamstring strength (at 60°/s: ST group, 17% ± 16%; ST/G group, 14% ± 11%; n.s.) or quadriceps strength (at 60°/s: ST group, 14% ± 12%; ST/G group, 19% ± 17%; n.s.), return to work, pain during physical activities, side-to-side differential laxity, balance, loss of flexion/extension, or surgical complications.
CONCLUSION


This trial demonstrates that functional outcomes after 4ST for ACLR with cortical fixations could be as good, although not better, than those obtained using ST/G. The 4ST technique spares the gracilis tendon, which thus preserves the medial sided muscle and thereby could improve function and limit donor-side morbidity.
LEVEL OF EVIDENCE


Level I.",2020,"No significant between-group differences were found for mean postoperative subjective IKDC (4ST group, 80.2 ± 12.5; ST/G group, 83.6 ± 13.6; n.s.), side-to-side percentage deficits in isokinetic hamstring strength (at 60°/s","[' 60 completed the study and were included, 33 in the 4ST group and 27 in the ST/G group', 'Mean age was 30.5\u2009±\u20098.9\xa0years in the 4ST group and 30.3\u2009±\u20098.5 in the ST/G group (n.s', 'Patients older than 16\xa0years who underwent primary isolated ACLR included for 1\xa0year until August 2017 were eligible', '66 eligible patients']","['anterior cruciate ligament reconstruction (ACLR) using a four-strand semitendinosus (ST) graft with adjustable femoral and tibial cortical fixation', 'ST/gracilis (ST/G) graft with femoral pin transfixation and tibial bioscrew fixation', 'ACL reconstruction']","['subjective International Knee Documentation Committee (IKDC) score, isokinetic muscle strength recovery, and return to work within 2\xa0years', 'quadriceps strength', 'mean postoperative subjective IKDC', 'return to work, pain during physical activities, side-to-side differential laxity, balance, loss of flexion/extension, or surgical complications', 'isokinetic hamstring strength']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus muscle structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0224453', 'cui_str': 'Semitendinosus muscle structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}]",66.0,0.0333182,"No significant between-group differences were found for mean postoperative subjective IKDC (4ST group, 80.2 ± 12.5; ST/G group, 83.6 ± 13.6; n.s.), side-to-side percentage deficits in isokinetic hamstring strength (at 60°/s","[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Roger', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, Hôpital de La Croix Rousse, Hospices Civils de Lyon, 103 Grande Rue de la Croix Rousse, 69004, Lyon, France. julien.roger@chu-lyon.fr.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Bertani', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France. antoine.bertani@chu-lyon.fr.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Vigouroux', 'Affiliation': ""Division of Orthopaedic Surgery, Department of Surgery, Hôpital d'Instruction des Armées Bégin, Service de Santé des Armées, Saint-Mandé, France.""}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Mottier', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, Centre Hospitalier Pierre Oudot, Bourgoin-Jallieu, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Gaillard', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, Hôpital de La Croix Rousse, Hospices Civils de Lyon, 103 Grande Rue de la Croix Rousse, 69004, Lyon, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Have', 'Affiliation': 'Department of Physical and Medical Rehabilitation, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Rongièras', 'Affiliation': 'Division of Orthopaedic Surgery, Department of Surgery, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06121-2']
1586,32665039,"Protecting Frontline Health Care Workers from COVID-19 with Hydroxychloroquine Pre-exposure Prophylaxis: A structured summary of a study protocol for a randomised placebo-controlled multisite trial in Toronto, Canada.","OBJECTIVES


Primary Objective: To determine if pre-exposure prophylaxis (PrEP) with 400mg hydroxychloroquine (HCQ), taken orally once daily reduces microbiologically confirmed COVID-19 among front line health care workers at high risk for SARS-CoV-2 exposure. Secondary Objectives: To compare the following between study arms: adverse events; symptomatic COVID-19; duration of symptomatic COVID-19; days hospitalized attributed to COVID-19; respiratory failure attributable to COVID-19 requiring i) non-invasive ventilation or ii) intubation/mechanical ventilation; mortality attributed to COVID-19, number of days unable to work attributed to COVID-19, seroconversion (COVID-19 negative to COVID-19 positive over the study period); ability of participant plasma to neutralize SARS-CoV-2 virus in vitro; To describe short-term psychological distress associated with risk of COVID-19 exposure at 1, 60, 120 days of the study. To explore laboratory markers within participants with confirmed COVID-19: including circulating markers of host immune and endothelial activation in participant plasma and their correlation with disease severity and outcome TRIAL DESIGN: The HEROS study is a two-arm, parallel-group, individually randomized (1:1 allocation ratio), placebo controlled, participant and investigator-blinded, multi-site superiority trial of oral HCQ 400 mg taken once daily for 90 days as PrEP to prevent COVID-19 in health care workers at high risk of SARS-CoV-2 exposure. At 90 days, there is an open label extension wherein all participants are offered a one-month course of HCQ 400mg once daily for PrEP of COVID-19.
PARTICIPANTS


Frontline HCWs aged 18 years of age or older, at high risk of SARS-CoV-2 exposure (including staff of emergency departments, intensive care units, intubation teams, COVID-wards, and staff deployed to Long Term Care facilities) of five academic hospitals in downtown Toronto, Canada. Exclusion criteria include: currently pregnant, planning to become pregnant during the study period, and/or breast feeding; known hypersensitivity/allergy to hydroxychloroquine or to 4-aminoquinoline compounds; current use of hydroxychloroquine; known prolonged QT syndrome and/or baseline resting ECG with QTc>450 ms and/or concomitant medications which simultaneously may prolong the QTc that cannot be temporarily suspended/replaced; known pre-existing retinopathy, G6PD deficiency, porphyria, liver disease including cirrhosis, encephalopathy, hepatitis or alcoholism, diabetes on oral hypoglycemics or insulin, or renal insufficiency/failure; disclosure of self-administered use of hydroxychloroquine or chloroquine within 12 weeks prior to study; confirmed symptomatic COVID-19 at time of enrollment.
INTERVENTION AND COMPARATOR


Intervention: hydroxychloroquine, 400mg (2 tablets) orally per day. Comparator: placebo, two tablets visually identical to the intervention, orally per day MAIN OUTCOMES: The primary outcome is microbiologically confirmed COVID-19 (i.e. SARS-CoV-2 infection). This is a composite endpoint which includes positive results from any validated SARS-CoV-2 diagnostic assay including detection of viral RNA, and/or seroconversion. Participants will be assessed at baseline, and then undergo monthly follow-up at day 30, 60, and 90, 120. At each visit, participants will provide an oropharyngeal sample, blood sample, and will undergo electrocardiogram monitoring of the QTc interval. Secondary outcome measures include: adverse events; symptom duration of COVID-19; days of hospitalization attributed to COVID-19; respiratory failure requiring ventilator support attributed to COVID-19; mortality attributed to COVID-19; total days off work attributed to COVID-19; seropositivity (reactive serology by day 120); and short term psychological impact of exposure to SARS-CoV-2 at day 1, 60, 120 days using the K10, a validated measure of non-specific psychological distress.
RANDOMISATION


Within each site, participants will be individually randomized to either the intervention arm with HCQ or the placebo arm using a fixed 1:1 allocation ratio using an interactive web-based response system to ensure concealment of allocation. Randomization schedules will be computer-generated and blocked using variable block sizes.
BLINDING (MASKING)


All participants, research coordinators, technicians, clinicians and investigators will be blinded to the participant allocation group. Numbers to be randomised (sample size) N=988, randomised into two groups of 494 patients.
TRIAL STATUS


This summary describes protocol version No. 1.6, May 15, 2020. Recruitment is ongoing - started April 20, 2020 and anticipated end date is July 30, 2021 TRIAL REGISTRATION: ISRCTN.com Identifier: ISRCTN14326006, registered April 14, 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"Secondary outcome measures include: adverse events; symptom duration of COVID-19; days of hospitalization attributed to COVID-19; respiratory failure requiring ventilator support attributed to COVID-19; mortality attributed to COVID-19; total days off work attributed to COVID-19; seropositivity (reactive serology by day 120); and short term psychological impact of exposure to SARS-CoV-2 at day 1, 60, 120 days using the K10, a validated measure of non-specific psychological distress.
","['Frontline HCWs aged 18 years of age or older, at high risk of SARS-CoV-2 exposure (including staff of emergency departments, intensive care units, intubation teams, COVID-wards, and staff deployed to Long Term Care facilities) of five academic hospitals in downtown Toronto, Canada', 'health care workers at high risk of SARS-CoV-2 exposure', 'participants with confirmed COVID-19', 'front line health care workers at high risk for SARS-CoV-2 exposure', '494 patients']","['invasive ventilation or ii) intubation/mechanical ventilation', 'ISRCTN.com', 'hydroxychloroquine', 'hydroxychloroquine or chloroquine', 'HCQ 400mg once daily for PrEP of COVID-19', 'Comparator: placebo', 'HCQ or the placebo', 'HCQ', 'hydroxychloroquine (HCQ', 'Hydroxychloroquine Pre-exposure Prophylaxis', 'placebo']","[' adverse events; symptom duration of COVID-19; days of hospitalization attributed to COVID-19; respiratory failure requiring ventilator support attributed to COVID-19; mortality attributed to COVID-19; total days off work attributed to COVID-19; seropositivity (reactive serology by day 120); and short term psychological impact of exposure to SARS-CoV-2', 'microbiologically confirmed COVID-19 (i.e. SARS-CoV-2 infection', 'validated measure of non-specific psychological distress']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0559457', 'cui_str': 'Number of days off work'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0036743', 'cui_str': 'Serologic test'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",,0.440916,"Secondary outcome measures include: adverse events; symptom duration of COVID-19; days of hospitalization attributed to COVID-19; respiratory failure requiring ventilator support attributed to COVID-19; mortality attributed to COVID-19; total days off work attributed to COVID-19; seropositivity (reactive serology by day 120); and short term psychological impact of exposure to SARS-CoV-2 at day 1, 60, 120 days using the K10, a validated measure of non-specific psychological distress.
","[{'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Wright', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Darrell H S', 'Initials': 'DHS', 'LastName': 'Tan', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Walmsley', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hulme', 'Affiliation': 'Divisions of Emergency Medicine, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': ""O'Connor"", 'Affiliation': 'Emergency Department, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Snider', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Ivy', 'Initials': 'I', 'LastName': 'Cheng', 'Affiliation': 'Divisions of Emergency Medicine, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Adrienne K', 'Initials': 'AK', 'LastName': 'Chan', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Bjug', 'Initials': 'B', 'LastName': 'Borgundvaag', 'Affiliation': 'Divisions of Emergency Medicine, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'McLeod', 'Affiliation': 'Divisions of Emergency Medicine, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Gollob', 'Affiliation': 'Division of Cardiology, Department of Medicine, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Rosemarie J', 'Initials': 'RJ', 'LastName': 'Clarke', 'Affiliation': 'Immunodeficiency Clinic, Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Dresser', 'Affiliation': 'Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Haji', 'Affiliation': 'Investigational Pharmacy Services, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Mazzulli', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Mubareka', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': ""Applied Health Research Centre (AHRC), St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tomlinson', 'Affiliation': 'Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Kain', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Landes', 'Affiliation': 'Divisions of Emergency Medicine, Department of Family and Community Medicine, University of Toronto, Toronto, Ontario, Canada. megan.landes@uhn.ca.'}]",Trials,['10.1186/s13063-020-04577-8']
1587,32665041,Breath Regulation and yogic Exercise An online Therapy for calm and Happiness (BREATH) for frontline hospital and long-term care home staff managing the COVID-19 pandemic: A structured summary of a study protocol for a feasibility study for a randomised controlled trial.,"OBJECTIVES


Objective 1: To determine if it is feasible to conduct an RCT of online Sudarshan Kriya Yoga (SKY) for frontline hospital and long-term care home staff under the constraints imposed by the COVID-19 pandemic and need for remote trial monitoring. Objective 2: To assess whether online versions of SKY and/or Health Enhancement Program (HEP) result in improvement in self-rated measures of insomnia, anxiety, depression, and resilience.
TRIAL DESIGN


This is an open-label feasibility randomized controlled trial (RCT), comparing an online breath based yogic intervention SKY versus an online control mind-body intervention HEP in frontline hospital and long-term care home staff managing the COVID-19 pandemic.
PARTICIPANTS


Participants will include frontline hospital and long-term care home staff that are involved in the management of COVID-19 patients in London, Ontario, Canada. Participants will be willing and able to attend via online video conferencing software to participate in the study interventions. Participants must have an adequate understanding of English and be able to sit without physical discomfort for 60 minutes.
INTERVENTION AND COMPARATOR


Sudarshan Kriya Yoga (SKY): The online version of SKY will be delivered by at least one certified Canadian SKY teacher, with at least one back up teacher at all times, under the supervision of Ms. Ronnie Newman, Director of Research and Health Promotion, Art of Living Foundation, USA. The online version of SKY for healthcare workers has a total duration of 3 hours. Phase I will consist of 5 self-paced online modules of 4-10 minutes each to learn the breath control techniques. Participants will be sent an online survey in REDCap requesting that they self-confirm completion of the Phase I modules. In Phase II, 2 interactive online sessions of 1 hour each will be held on consecutive days with a certified SKY teacher, during which participants will learn the fast, medium and slow breaths. For ease of scheduling, multiple time windows will be offered for Phase II. There will be at least one back up teacher at all times. Both Phase I and II will be completed in the first week. Health Enhancement Program (HEP): The active control arm, HEP, will consist of time-matched online self-paced modules for Phase I. Phase II will consist of mindfulness-based meditation sessions delivered by mental health staff. HEP will be an active treatment program that incorporates mind-body interventions. HEP will consist of time-matched online self-paced modules with psychoeducation on healthy active living as well as interactive modules comprising of guided de-stressing exercises including music therapy, mindfulness and progressive muscle relaxation. Weekly follow up sessions will be offered to all recruited participants for 30 minutes each for the subsequent 4 weeks in both study arms.
MAIN OUTCOMES


The following feasibility outcomes will be measured at the end of the study: (1) rate of participant recruitment, (2) rate of retention, (3) completeness of data entry, (4) cost of interventions, and (5) unexpected costs. Such measures will be collected on a daily basis through-out the study and tabulated 5 weeks later at the end of the study.
RANDOMISATION


Participants will be randomized after they have electronically signed the consent form and the research staff have confirmed eligibility. We will use REDCap to perform randomization in a 1:1 ratio as well as allocation concealment. REDCap is widely used by health researchers worldwide to significantly reduce data entry and study management errors to improve data fidelity.
BLINDING (MASKING)


All study participants will be blinded to the study hypotheses so as to prevent any expectation bias. Group allocation will be masked during analysis.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


This study will randomize a total of 60 participants in a 1:1 ratio to either SKY or HEP interventions.
TRIAL STATUS


Protocol version number 2.0 (June 5, 2020). Recruitment is currently ongoing (starting June 25, 2020). We anticipate to complete recruitment by June 30, 2021 and complete the study by September 30, 2021.
TRIAL REGISTRATION


ClinicalTrials.gov protocol ID NCT04368676 (posted April 30, 2020).
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Weekly follow up sessions will be offered to all recruited participants for 30 minutes each for the subsequent 4 weeks in both study arms.
","['60 participants in a 1:1 ratio to either SKY or HEP interventions', 'Protocol version number 2.0 (June 5, 2020', 'Participants will include frontline hospital and long-term care home staff that are involved in the management of COVID-19 patients in London, Ontario, Canada']","['HEP', 'Health Enhancement Program (HEP', 'Sudarshan Kriya Yoga (SKY', 'online versions of SKY and/or Health Enhancement Program (HEP', 'REDCap']","['Breath Regulation and yogic Exercise', 'insomnia, anxiety, depression, and resilience', 'rate of participant recruitment, (2) rate of retention, (3) completeness of data entry, (4) cost of interventions, and (5) unexpected costs']","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",60.0,0.152288,"Weekly follow up sessions will be offered to all recruited participants for 30 minutes each for the subsequent 4 weeks in both study arms.
","[{'ForeName': 'Ka Sing Paris', 'Initials': 'KSP', 'LastName': 'Lai', 'Affiliation': 'Department of Psychiatry, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Watt', 'Affiliation': 'Department of Psychiatry, Parkwood Institute of Mental Health, 550 Wellington Rd, London, ON, N6C 5J1, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Ionson', 'Affiliation': 'Department of Psychiatry, Parkwood Institute of Mental Health, 550 Wellington Rd, London, ON, N6C 5J1, Canada.'}, {'ForeName': 'Imants', 'Initials': 'I', 'LastName': 'Baruss', 'Affiliation': ""Department of Psychology, King's University College at Western University, 266 Epworth Ave, London, ON, N6A 2M3, Canada.""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Forchuk', 'Affiliation': 'Department of Psychiatry, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada.'}, {'ForeName': 'Javeed', 'Initials': 'J', 'LastName': 'Sukhera', 'Affiliation': 'Department of Psychiatry, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada.'}, {'ForeName': 'Amer M', 'Initials': 'AM', 'LastName': 'Burhan', 'Affiliation': 'Department of Psychiatry, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada.'}, {'ForeName': 'Akshya', 'Initials': 'A', 'LastName': 'Vasudev', 'Affiliation': 'Department of Psychiatry, Western University, 1151 Richmond St, London, ON, N6A 3K7, Canada. akshya.vasudev@lhsc.on.ca.'}]",Trials,['10.1186/s13063-020-04583-w']
1588,32665040,The Australasian COVID-19 Trial (ASCOT) to assess clinical outcomes in hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


To determine if lopinavir/ritonavir +/- hydroxychloroquine will reduce the proportion of participants who survive without requiring ventilatory support, 15 days after enrolment, in adult participants with non-critically ill SARS-CoV-2 infection.
TRIAL DESIGN


ASCOT is an investigator-initiated, multi-centre, open-label, randomised controlled trial. Participants will have been hospitalised with confirmed COVID-19, and will be randomised 1:1:1:1 to receive lopinavir /ritonavir, hydroxychloroquine, both or neither drug in addition to standard of care management.
PARTICIPANTS


Participants will be recruited from >80 hospitals across Australia and New Zealand, representing metropolitan and regional centres in both public and private sectors. Admitted patients will be eligible if aged ≥ 18 years, have confirmed SARS-CoV-2 by nucleic acid testing in the past 12 days and are expected to remain an inpatient for at least 48 hours from the time of randomisation. Potentially eligible participants will be excluded if admitted to intensive care or requiring high level respiratory support, are currently receiving study drugs or their use is contraindicated due to allergy, drug interaction or comorbidities (including baseline QTc prolongation of 470ms for women or 480ms for men), or death is anticipated imminently.
INTERVENTION AND COMPARATOR


Participants will be randomised 1:1:1:1 to: Group 1: standard of care; Group 2: lopinavir (400mg) / ritonavir (100mg) twice daily for 10 days in tablet form; Group 3: hydroxychloroquine (800mg) 4x200mg administered 12 hours apart on Day 1, followed by 400mg twice a day for 6 days; Group 4: lopinavir /ritonavir plus hydroxychloroquine.
MAIN OUTCOMES


Proportion of participants alive and not having required intensive respiratory support (invasive or non-invasive ventilation) at 15 days after enrolment. A range of clinical and virological secondary outcomes will also be evaluated.
RANDOMISATION


The randomisation schedule will be generated by an independent statistician. Randomisation will be stratified by site and will be in permuted blocks of variable block size. The randomised sequence allocation will only be accessible to the data management group, and site investigators will have individual participant allocation provided through a web-based trial enrolment platform.
BLINDING (MASKING)


This is an open-label study, with researchers assessing the laboratory outcomes blinded to treatment allocation. No unblinding procedures relating to potential adverse effects are therefore required.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


We assumed that 5% of participants receiving standard of care would meet the primary outcome, aimed to evaluate whether interventions could lead to a relative risk of 0.5, assuming no interaction between intervention arms. This corresponds to a required sample size of 610 per arm, with a 5% two-sided significance level (alpha) and 80% power. The total sample size therefore is planned to be 2440.
TRIAL STATUS


ASCOT protocol version 3, May 5, 2020. Recruitment opened April 4, 2020 and is ongoing, with planned completion of enrolment July 31, 2021.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ( ACTRN12620000445976 ). Prospectively registered April 6, 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"hydroxychloroquine will reduce the proportion of participants who survive without requiring ventilatory support, 15 days after enrolment, in adult participants with non-critically ill SARS-CoV-2 infection.
","['Potentially eligible participants will be excluded if admitted to intensive care or requiring high level respiratory support, are currently receiving study drugs or their use is contraindicated due to allergy, drug interaction or comorbidities (including baseline QTc prolongation of 470ms for women or 480ms for men), or death is anticipated imminently', 'Admitted patients will be eligible if aged ≥ 18 years', 'Participants will be recruited from >80 hospitals across Australia and New Zealand, representing metropolitan and regional centres in both public and private sectors', 'participants who survive without requiring ventilatory support, 15 days after enrolment, in adult participants with non-critically ill SARS-CoV-2 infection', 'hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with', 'compared to standard of care']","['lopinavir /ritonavir plus hydroxychloroquine', 'lopinavir/ritonavir ', 'hydroxychloroquine', 'lopinavir /ritonavir, hydroxychloroquine', 'lopinavir/ritonavir and/or hydroxychloroquine', 'lopinavir (400mg) / ritonavir']",['Proportion of participants alive and not having required intensive respiratory support (invasive or non-invasive ventilation'],"[{'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0678798', 'cui_str': 'Adverse drug interaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0855333', 'cui_str': 'Electrocardiogram QT corrected interval prolonged'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0558281', 'cui_str': 'Regional center'}, {'cui': 'C0033176', 'cui_str': 'Private Sector'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}]","[{'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]",,0.374402,"hydroxychloroquine will reduce the proportion of participants who survive without requiring ventilatory support, 15 days after enrolment, in adult participants with non-critically ill SARS-CoV-2 infection.
","[{'ForeName': 'Justin T', 'Initials': 'JT', 'LastName': 'Denholm', 'Affiliation': 'Victorian Infectious Diseases Service, The Royal Melbourne Hospital, and Doherty Department University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, 792 Elizabeth Street, Melbourne, Victoria, Australia. justin.denholm@mh.org.au.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Darwin, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Paterson', 'Affiliation': 'University of Queensland Centre for Clinical Research, Faculty of Medicine & Centre for Translational Anti-infective Pharmacodynamics, School of Pharmacy, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'University of Queensland Centre for Clinical Research, Faculty of Medicine & Centre for Translational Anti-infective Pharmacodynamics, School of Pharmacy, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Morpeth', 'Affiliation': 'Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Snelling', 'Affiliation': 'School of Public Health, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Dominica', 'Initials': 'D', 'LastName': 'Zentner', 'Affiliation': 'Department of Cardiology, The Royal Melbourne Hospital and Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rees', 'Affiliation': 'Department of Respiratory Medicine, The Royal Melbourne Hospital and Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': ""O'Sullivan"", 'Affiliation': 'Centre for Infectious Diseases and Microbiology, Westmead Hospital, Westmead, New South Wales, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': 'Centre for Epidemiology & Biostatistics, Melbourne School of Population & Global Health, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Bowen', 'Affiliation': 'Telehealth Kids Institute, Perth, West Australia, Australia.'}, {'ForeName': 'Steven Y C', 'Initials': 'SYC', 'LastName': 'Tong', 'Affiliation': 'Victorian Infectious Diseases Service, The Royal Melbourne Hospital, and Doherty Department University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, 792 Elizabeth Street, Melbourne, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04576-9']
1589,32671129,Primed for Health: Future Thinking Priming Decreases Delay Discounting.,"Objective


Delay discounting, the propensity to devalue delayed rewards, has robust predictive validity for multiple health behaviors and is a new therapeutic target for health behavior change. Priming can influence behaviors in a predictable manner. We aimed to use the Future Thinking Priming task, administered remotely, to reliably decrease delay discounting rates.
Methods


In this pre-post randomized control group design, participants completed multiple delay discounting measures at baseline; then, 2 weeks later, they were randomized to Future Thinking Priming or Neutral Priming conditions. We hypothesized that Future Thinking Priming would significantly decrease delay discounting rates accounting for baseline delay discounting rates and time in repeated measures analyses.
Results


Participants randomized to Future Thinking Priming (N = 783) demonstrated significantly lower delay discounting rates post-intervention than those randomized to Neutral Priming (N = 747) on multiple delay discounting measures and magnitudes.
Conclusions


A single administration of Future Thinking Priming produces statistically reliable reductions in delay discounting rates. The task is brief, can be administered remotely, and is highly scalable. If found to support behavior change, the task might be disseminated broadly to enhance evidence-based behavior change interventions. Future research must determine optimal exposure patterns to support durable health behavior change.",2019,"Results


Participants randomized to Future Thinking Priming (N = 783) demonstrated significantly lower delay discounting rates post-intervention than those randomized to Neutral Priming (N = 747) on multiple delay discounting measures and magnitudes.
",[],['Future Thinking Priming or Neutral Priming conditions'],['delay discounting rates'],[],"[{'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C3850035', 'cui_str': 'Intertemporal Preferences'}]",,0.049171,"Results


Participants randomized to Future Thinking Priming (N = 783) demonstrated significantly lower delay discounting rates post-intervention than those randomized to Neutral Priming (N = 747) on multiple delay discounting measures and magnitudes.
","[{'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Shevorykin', 'Affiliation': 'Pace University, New York, NY.'}, {'ForeName': 'Jami C', 'Initials': 'JC', 'LastName': 'Pittman', 'Affiliation': 'Wayne State University, Detroit, MI.'}, {'ForeName': 'Warren K', 'Initials': 'WK', 'LastName': 'Bickel', 'Affiliation': 'Advanced Recovery Research Center, Virginia Tech Carilion Research Institute, Roanoke, VA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': ""O'Connor"", 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}, {'ForeName': 'Ria', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'City University of New York Medical School, New York, NY.'}, {'ForeName': 'Neelam', 'Initials': 'N', 'LastName': 'Prashad', 'Affiliation': 'Columbia University, New York, NY.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Sheffer', 'Affiliation': 'Roswell Park Comprehensive Cancer Center, Buffalo, NY.'}]",Health behavior and policy review,['10.14485/hbpr.6.4.5']
1590,32668823,Effects of α-tocopherol on hemolysis and oxidative stress markers on red blood cells in β-thalassemia major.,"BACKGROUND


The accumulation of unpaired α-globin chains in patients with β-thalassemia major may clinically create ineffective erythropoiesis, hemolysis, and chronic anemia. Multiple blood transfusions and iron overload cause cellular oxidative damage. However, α-tocopherol, an antioxidant, is a potent scavenger of lipid radicals in the membranes of red blood cells (RBCs) of patients with β-thalassemia major.
PURPOSE


To evaluate the effects of α-tocopherol on hemolysis and oxidative stress markers on the RBC membranes of patients with β-thalassemia major.
METHODS


Forty subjects included in this randomized controlled trial were allocated to the placebo and α-tocopherol groups. Doses of α-tocopherol were based on Institute of Medicine recommendations: 4-8 years old, 200 mg/day; 9-13 years old, 400 mg/day; 14-18 years old, 600 mg/day. Hemolysis, oxidative stress, and antioxidant variables were evaluated before and after 4-week α-tocopherol or placebo treatment, performed before blood transfusions.
RESULTS


Significant enhancements in plasma haptoglobin were noted in the α-tocopherol group (3.01 mg/dL; range, 0.60-42.42 mg/dL; P=0.021). However, there was no significant intergroup difference in osmotic fragility test results; hemopexin, malondialdehyde, reduced glutathione (GSH), or oxidized glutathione (GSSG) levels; or GSH/GSSG ratio.
CONCLUSION


Use of α-tocopherol could indirectly improve hemolysis and haptoglobin levels. However, it played no significant role in oxidative stress or as an endogen antioxidant marker in β-thalassemia major.",2020,"Results


Significant enhancements in plasma haptoglobin were noted in the α-tocopherol group (3.01 mg/dL; range, 0.60-42.42 mg/dL; P=0.021).","['Methods\n\n\nForty subjects', 'β-thalassemia major', 'patients with β-thalassemia major']","['α-tocopherol or placebo', 'placebo and α-tocopherol', 'α-tocopherol']","['hemolysis and haptoglobin levels', 'oxidative stress', 'Hemolysis, oxidative stress, and antioxidant variables', 'plasma haptoglobin', 'osmotic fragility test results; hemopexin, malondialdehyde, reduced glutathione (GSH), or oxidized glutathione (GSSG) levels; or GSH/GSSG ratio']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0002875', 'cui_str': 'Homozygous beta thalassemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0019054', 'cui_str': 'Haemolysis'}, {'cui': 'C0018595', 'cui_str': 'Haptoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0029392', 'cui_str': 'Osmotic fragility'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019067', 'cui_str': 'Hemopexin'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0202053', 'cui_str': 'Glutathione measurement'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",40.0,0.0385745,"Results


Significant enhancements in plasma haptoglobin were noted in the α-tocopherol group (3.01 mg/dL; range, 0.60-42.42 mg/dL; P=0.021).","[{'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Sovira', 'Affiliation': 'Division of Pediatric Emergency & Intensive Care, Department of Pediatrics, Faculty of Medicine, University of Syiah Kualal/Dr. Zainoel Abidin Hospital, Banda Aceh, Indonesia.'}, {'ForeName': 'Munar', 'Initials': 'M', 'LastName': 'Lubis', 'Affiliation': 'Division of Pediatric Emergency & Intensive Care, Department of Pediatrics, Faculty of Medicine, University of Sumatera Utara/University of Sumatera Utara Hospital, Medan, Indonesia.'}, {'ForeName': 'Pustika Amalia', 'Initials': 'PA', 'LastName': 'Wahidiyat', 'Affiliation': 'Division of Hematology Oncology, Department of Pediatrics, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Franciscus D', 'Initials': 'FD', 'LastName': 'Suyatna', 'Affiliation': 'Department of Pharmacology and Therapeutics, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Djajadiman', 'Initials': 'D', 'LastName': 'Gatot', 'Affiliation': 'Division of Hematology Oncology, Department of Pediatrics, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Saptawati', 'Initials': 'S', 'LastName': 'Bardosono', 'Affiliation': 'Department of Nutrition, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sadikin', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Faculty of Medicine, University of Indonesia/Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}]",Clinical and experimental pediatrics,['10.3345/cep.2019.00542']
1591,32673552,Exogenous testosterone increases the audience effect in healthy males: evidence for the social status hypothesis.,"Several studies have implicated testosterone in the modulation of altruistic behaviours instrumental to advancing social status. Independent studies have also shown that people tend to behave more altruistically when being watched (i.e. audience effect). To date, little is known about whether testosterone could modulate the audience effect. In the current study, we tested the effect of testosterone on altruistic behaviour using a donation task, wherein participants were asked to either accept or reject a monetary transfer to a charity organization accompanying a personal cost either in the presence or absence of an observer. We administered testosterone gel or placebo to healthy young men ( n  = 140) in a double-blind, placebo-controlled, mixed design. Our results showed that participants were more likely to accept the monetary transfer to the charity when being observed compared to when they completed the task alone. More importantly, this audience effect was amplified among people receiving testosterone versus placebo. Our findings suggest that testosterone administration increases the audience effect and further buttress the social status hypothesis, according to which testosterone promotes status-seeking behaviour in a context-dependent manner.",2020,"In the current study, we tested the effect of testosterone on altruistic behaviour using a donation task, wherein participants were asked to either accept or reject a monetary transfer to a charity organization accompanying a personal cost either in the presence or absence of an observer.","['healthy young men ( n  = 140', 'healthy males']","['testosterone gel or placebo', 'testosterone', 'Exogenous testosterone', 'placebo']",[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}]",[],,0.132428,"In the current study, we tested the effect of testosterone on altruistic behaviour using a donation task, wherein participants were asked to either accept or reject a monetary transfer to a charity organization accompanying a personal cost either in the presence or absence of an observer.","[{'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""School of Psychology, Shenzhen University, Shenzhen 518060, People's Republic of China.""}, {'ForeName': 'Yinhua', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""School of Psychology, Shenzhen University, Shenzhen 518060, People's Republic of China.""}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Ou', 'Affiliation': ""School of Psychology, Shenzhen University, Shenzhen 518060, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""School of Psychological and Cognitive Sciences, Peking University, Beijing 100871, People's Republic of China.""}, {'ForeName': 'Samuele', 'Initials': 'S', 'LastName': 'Zilioli', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, MI 48202, USA.'}]",Proceedings. Biological sciences,['10.1098/rspb.2020.0976']
1592,32687924,"Intake of Lactiplantibacillus plantarum HEAL9 reduces the inflammatory markers soluble fractalkine and CD163 during acute stress: A randomized, double blind, placebo-controlled study.","The intestine and the brain are connected via the brain-gut axis and the intestinal microbiota influences the immune activation and signaling molecules that are involved in the stress response. The aim of the study was to investigate if intake of the probiotic strain Lactiplantibacillus plantarum HEAL9 (LPHEAL9) for four weeks could counteract elevated cortisol and inflammation levels in subjects with chronic stress that are exposed to an acute stress test (Trier Social Stress Test, TSST). Seventy participants were included, and 63 participants completed the study (LPHEAL9, n = 32; placebo, n  =  31). Cardiovascular reactivity and cortisol levels were affected by the TSST, but no differences between the groups were observed. Intake of LPHEAL9 did, however, result in significantly decreased plasma levels of two inflammatory markers (soluble fractalkine and CD163) compared to placebo. In conclusion, intake of LPHEAL9 for four weeks may reduce inflammatory markers coupled to acute stress in chronically stressed individuals.",2020,"Intake of LPHEAL9 did, however, result in significantly decreased plasma levels of two inflammatory markers (soluble fractalkine and CD163) compared to placebo.","['acute stress', 'subjects with chronic stress', 'chronically stressed individuals', 'Seventy participants were included, and 63 participants completed the study (LPHEAL9, n=32; placebo, n=31']","['probiotic strain Lactobacillus plantarum HEAL9 (LPHEAL9', 'Lactobacillus plantarum HEAL9', 'placebo']","['elevated cortisol and inflammation levels', 'plasma levels', 'Cardiovascular reactivity and cortisol levels']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]",70.0,0.191303,"Intake of LPHEAL9 did, however, result in significantly decreased plasma levels of two inflammatory markers (soluble fractalkine and CD163) compared to placebo.","[{'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Önning', 'Affiliation': 'Biomedical Nutrition, Pure and Applied Biochemistry, Lund University, Lund, Sweden; Probi AB, Lund, Sweden. Electronic address: gunilla.onning@probi.com.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Hillman', 'Affiliation': 'Department of Clinical Sciences Lund, Diabetes Research Laboratory, Lund University, Lund, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hedin', 'Affiliation': 'Department of Food Technology, Engineering and Nutrition, Lund University, Lund, Sweden.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Montelius', 'Affiliation': 'Probi AB, Lund, Sweden.'}, {'ForeName': 'Joakim', 'Initials': 'J', 'LastName': 'Eriksson', 'Affiliation': 'Ergonomics and Aerosol Technology, Department of Design Studies, Lund University, Lund, Sweden.'}, {'ForeName': 'Siv', 'Initials': 'S', 'LastName': 'Ahrné', 'Affiliation': 'Department of Food Technology, Engineering and Nutrition, Lund University, Lund, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jönsson', 'Affiliation': 'Department of Psychology, Faculty of Education, Kristianstad University, Kristianstad, Sweden.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113083']
1593,32679757,Characterizing the Heart Rate Response to the 4 × 4 Interval Exercise Protocol.,"High intensity interval training is frequently implemented using the 4 × 4 protocol where four 4-min bouts are performed at heart rate (HR) between 85 and 95% HR max. This study identified the HR and power output response to the 4 × 4 protocol in 39 active men and women (age and VO 2  max = 26.0 ± 6.1 years and 37.0 ± 5.4 mL/kg/min). Initially, participants completed incremental cycling to assess VO 2  max, HR max, and peak power output (PPO). They subsequently completed the 4 × 4 protocol, during which HR and power output were monitored. Data showed that 12.9 ± 0.4 min of 16 min were spent between 85 and 95% HR max, with time spent significantly lower in interval 1 (2.7 ± 0.6 min) versus intervals 2-4 (3.4 ± 0.4 min, 3.4 ± 0.3 min, and 3.5 ± 0.3 min,  d  = 2.4-2.7). Power output was highest in interval 1 (75% PPO) and significantly declined in intervals 2-4 (63 to 54% PPO,  d  = 0.7-1.0). To enhance time spent between 85 and 95% HR max for persons with higher fitness, we recommend immediate allocation of supramaximal intensities in interval one.",2020,"Power output was highest in interval 1 (75% PPO) and significantly declined in intervals 2-4 (63 to 54% PPO,  d  = 0.7-1.0).",['39 active men and women (age and VO 2  max = 26.0 ± 6.1 years and 37.0 ± 5.4 mL/kg/min'],['High intensity interval training'],"['VO 2  max, HR max, and peak power output (PPO', 'Power output', 'Heart Rate Response']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0032956', 'cui_str': 'Preferred Provider Organization'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}]",,0.0733088,"Power output was highest in interval 1 (75% PPO) and significantly declined in intervals 2-4 (63 to 54% PPO,  d  = 0.7-1.0).","[{'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Acala', 'Affiliation': 'Department of Kinesiology, California State University, San Marcos, CA 92096-0001, USA.'}, {'ForeName': 'Devyn', 'Initials': 'D', 'LastName': 'Roche-Willis', 'Affiliation': 'Department of Kinesiology, California State University, San Marcos, CA 92096-0001, USA.'}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Astorino', 'Affiliation': 'Department of Kinesiology, California State University, San Marcos, CA 92096-0001, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17145103']
1594,32682457,"S-1 plus leucovorin and oxaliplatin versus S-1 plus cisplatin as first-line therapy in patients with advanced gastric cancer (SOLAR): a randomised, open-label, phase 3 trial.","BACKGROUND


S-1 plus leucovorin and oxaliplatin showed promising efficacy for treatment of advanced gastric cancer in a randomised phase 2 study. We aimed to evaluate the efficacy and safety of oral TAS-118 (S-1 plus leucovorin) and oxaliplatin versus S-1 plus cisplatin in patients with advanced gastric cancer.
METHODS


We did a randomised, open-label, phase 3 trial in 62 centres across Japan and South Korea. Patients aged 20 years or older, with a histologically confirmed advanced gastric cancer with negative or unknown HER2 status, with Eastern Cooperative Oncology Group performance status of 0 or 1, measurable or evaluable metastatic lesions, and no previous treatment were randomly assigned (1:1) via an interactive web response system using the minimisation method, stratified by performance status, presence of a measurable lesion, and country, to receive TAS-118 (S-1 40-60 mg and leucovorin 25 mg orally twice daily for 7 days) plus oxaliplatin (85 mg/m 2  intravenously on day 1) every 2 weeks, or S-1 (40-60 mg orally twice daily) for 21 days plus cisplatin (60 mg/m 2  intravenously on day 1 or 8) every 5 weeks. The primary endpoint was overall survival in patients who had advanced gastric cancer with measurable or evaluable metastatic lesions and who received the study drug. Safety was assessed in all patients who received the study drug. This study was registered at ClinicalTrials.gov, NCT02322593.
FINDINGS


Between Jan 28, 2015, and Dec 5, 2016, 711 patients were randomised to TAS-118 plus oxaliplatin (n=356) or S-1 plus cisplatin (n=355). 11 untreated patients and 19 ineligible patients were excluded from the primary analysis (TAS-118 plus oxaliplatin group n=347, S-1 plus cisplatin group n=334) following recommendation from the independent data monitoring committee. After median follow-up of 26·0 months (IQR 22·0-32·8), median overall survival was 16·0 months (95% CI 13·8-18·3) in the TAS-118 plus oxaliplatin group and 15·1 months (95% CI 13·6-16·4) in the S-1 plus cisplatin group (hazard ratio 0·83, 95% CI 0·69-0·99; p=0·039). The most common grade 3 or higher adverse events in the 352 patients in the TAS-118 plus oxaliplatin group and the 348 patients in the S-1 plus cisplatin group were anaemia (56 [16%] vs 64 [18%]), neutropenia (54 [15%] vs 88 [25%]), decreased appetite (53 [15%] vs 46 [13%]), diarrhoea (33 [9%] vs 15 [4%]), and peripheral sensory neuropathy (30 [9%] vs one [<1%]). Serious adverse events were observed in 155 (44%) of 352 patients in the TAS-118 plus oxaliplatin group and 159 (46%) of 348 patients in the S-1 plus cisplatin group. Two treatment-related deaths occurred in the TAS-118 plus oxaliplatin group (pulmonary tuberculosis and viral pneumonia).
INTERPRETATION


TAS-118 plus oxaliplatin showed a clinically meaningful improvement in efficacy compared with S-1 plus cisplatin, and could be considered a new first-line treatment option for advanced gastric cancer in Asian patients.
FUNDING


Taiho Pharmaceutical and Yakult Honsha.",2020,"Two treatment-related deaths occurred in the TAS-118 plus oxaliplatin group (pulmonary tuberculosis and viral pneumonia).
","['advanced gastric cancer in Asian patients', 'patients with advanced gastric cancer (SOLAR', 'Patients aged 20 years or older, with a histologically confirmed advanced gastric cancer with negative or unknown HER2 status, with Eastern Cooperative Oncology Group performance status of 0 or 1, measurable or evaluable metastatic lesions, and no previous treatment', 'patients with advanced gastric cancer', 'Between Jan 28, 2015, and Dec 5, 2016, 711 patients', '11 untreated patients and 19 ineligible patients were excluded from the primary analysis ', '62 centres across Japan and South Korea', 'group n=334) following recommendation from the independent data monitoring committee', 'advanced gastric cancer', 'patients who had advanced gastric cancer with measurable or evaluable metastatic lesions and who received the study drug']","['oxaliplatin', 'TAS-118 (S-1 40-60 mg and leucovorin 25 mg orally twice daily for 7 days) plus oxaliplatin', 'TAS-118 plus oxaliplatin', 'S-1', 'leucovorin and oxaliplatin', 'cisplatin', 'S-1 plus cisplatin', 'S-1 plus leucovorin and oxaliplatin versus S-1 plus cisplatin', 'oral TAS-118 (S-1 plus leucovorin) and oxaliplatin versus S-1 plus cisplatin']","['Safety', 'neutropenia', 'overall survival', 'diarrhoea', 'efficacy and safety', 'anaemia', 'peripheral sensory neuropathy', 'median overall survival', 'adverse events', 'deaths', 'decreased appetite', 'Serious adverse events']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0559483', 'cui_str': 'Pentalogy of Cantrell'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C1125365', 'cui_str': 'Leucovorin 25 MG'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}]",11.0,0.251793,"Two treatment-related deaths occurred in the TAS-118 plus oxaliplatin group (pulmonary tuberculosis and viral pneumonia).
","[{'ForeName': 'Yoon-Koo', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Department of Oncology, Asan Medical Centre, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Keisho', 'Initials': 'K', 'LastName': 'Chin', 'Affiliation': 'Department of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'Division of Medical Oncology, Institute for Cancer Research, Yonsei University College of Medicine, Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Centre Hospital, Aichi, Japan.'}, {'ForeName': 'Sang Cheul', 'Initials': 'SC', 'LastName': 'Oh', 'Affiliation': 'Department of Oncology, Korea University Guro Hospital, Korea University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Norisuke', 'Initials': 'N', 'LastName': 'Nakayama', 'Affiliation': 'Department of Gastroenterology, Kanagawa Cancer Centre, Kanagawa, Japan.'}, {'ForeName': 'Keun-Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Division of Haematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Centre, Saitama, Japan.'}, {'ForeName': 'Ik-Joo', 'Initials': 'IJ', 'LastName': 'Chung', 'Affiliation': 'Department of Haematology-Oncology, Chonnam National University Hwasun Hospital, Chonnam National University College of Medicine, Hwasun, South Korea.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Tsuda', 'Affiliation': 'Department of Gastroenterological Oncology, Hyogo Cancer Centre, Hyogo, Japan.'}, {'ForeName': 'Se Hoon', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Medicine, Division of Haematology-Oncology, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Hosaka', 'Affiliation': 'Department of Gastroenterology, Gunma Prefectural Cancer Centre, Gunma, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Clinical Trial Promotion Department, Chiba Cancer Centre, Chiba, Japan.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Miyata', 'Affiliation': 'Department of Medical Oncology, Saku Central Hospital Advanced Care Centre, Nagano, Japan.'}, {'ForeName': 'Min-Hee', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'Department of Oncology, Asan Medical Centre, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Baba', 'Affiliation': 'Department of Gastroenterological Surgery, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Department of Gastroenterology, Faculty of Medicine, University of Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Yung-Jue', 'Initials': 'YJ', 'LastName': 'Bang', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Centre Hospital, Tokyo, Japan. Electronic address: nboku@ncc.go.jp.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30315-6']
1595,32682483,Dexmedetomidine for reduction of atrial fibrillation and delirium after cardiac surgery (DECADE): a randomised placebo-controlled trial.,"BACKGROUND


Atrial fibrillation and delirium are common consequences of cardiac surgery. Dexmedetomidine has unique properties as sedative agent and might reduce the risk of each complication. This study coprimarily aimed to establish whether dexmedetomidine reduces the incidence of new-onset atrial fibrillation and the incidence of delirium.
METHODS


A randomised, placebo-controlled trial was done at six academic hospitals in the USA. Patients who had had cardiac surgery with cardiopulmonary bypass were enrolled. Patients were randomly assigned 1:1, stratified by site, to dexmedetomidine or normal saline placebo. Randomisation was computer generated with random permuted block size 2 and 4, and allocation was concealed by a web-based system. Patients, caregivers, and evaluators were all masked to treatment. The study drug was prepared by the pharmacy or an otherwise uninvolved research associate so that investigators and clinicians were fully masked to allocation. Participants were given either dexmedetomidine infusion or saline placebo started before the surgical incision at a rate of 0·1 μg/kg per h then increased to 0·2 μg/kg per h at the end of bypass, and postoperatively increased to 0·4 μg/kg per h, which was maintained until 24 h. The coprimary outcomes were atrial fibrillation and delirium occurring between intensive care unit admission and the earlier of postoperative day 5 or hospital discharge. All analyses were intention-to-treat. The trial is registered with ClinicalTrials.gov, NCT02004613 and is closed.
FINDINGS


798 patients of 3357 screened were enrolled from April 17, 2013, to Dec 6, 2018. The trial was stopped per protocol after the last designated interim analysis. Among 798 patients randomly assigned, 794 were analysed, with 400 assigned to dexmedetomidine and 398 assigned to placebo. The incidence of atrial fibrillation was 121 (30%) in 397 patients given dexmedetomidine and 134 (34%) in 395 patients given placebo, a difference that was not significant: relative risk 0·90 (97·8% CI 0·72, 1·15; p=0·34). The incidence of delirium was non-significantly increased from 12% in patients given placebo to 17% in those given dexmedetomidine: 1·48 (97·8% CI 0·99-2·23). Safety outcomes were clinically important bradycardia (requiring treatment) and hypotension, myocardial infarction, stroke, surgical site infection, pulmonary embolism, deep venous thrombosis, and death. 21 (5%) of 394 patients given dexmedetomidine and 8 (2%) of 396 patients given placebo, had a serious adverse event as determined by clinicians. 1 (<1%) of 391 patients given dexmedetomidine and 1 (<1%) of 387 patients given placebo died.
INTERPRETATION


Dexmedetomidine infusion, initiated at anaesthetic induction and continued for 24 h, did not decrease postoperative atrial arrhythmias or delirium in patients recovering from cardiac surgery. Dexmedetomidine should not be infused to reduce atrial fibrillation or delirium in patients having cardiac surgery.
FUNDING


Hospira Pharmaceuticals.",2020,The incidence of delirium was non-significantly increased from 12% in patients given placebo to 17% in those given dexmedetomidine: 1·48 (97·8% CI 0·99-2·23).,"['six academic hospitals in the USA', '798 patients of 3357 screened were enrolled from April 17, 2013, to Dec 6, 2018', '391 patients given', 'patients recovering from cardiac surgery', '394 patients given', 'patients having cardiac surgery', '798 patients randomly assigned, 794 were analysed, with 400 assigned to', 'atrial fibrillation and delirium after cardiac surgery (DECADE', 'Patients who had had cardiac surgery with cardiopulmonary bypass were enrolled']","['dexmedetomidine infusion or saline placebo', 'dexmedetomidine or normal saline placebo', 'Dexmedetomidine', 'dexmedetomidine', 'placebo']","['incidence of atrial fibrillation', 'relative risk 0·90', 'postoperative atrial arrhythmias or delirium', 'atrial fibrillation and delirium occurring between intensive care unit admission and the earlier of postoperative day 5 or hospital discharge', 'serious adverse event', 'incidence of delirium', 'atrial fibrillation or delirium', 'important bradycardia (requiring treatment) and hypotension, myocardial infarction, stroke, surgical site infection, pulmonary embolism, deep venous thrombosis, and death', 'incidence of new-onset atrial fibrillation']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0085611', 'cui_str': 'Atrial arrhythmia'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]",3357.0,0.797581,The incidence of delirium was non-significantly increased from 12% in patients given placebo to 17% in those given dexmedetomidine: 1·48 (97·8% CI 0·99-2·23).,"[{'ForeName': 'Alparslan', 'Initials': 'A', 'LastName': 'Turan', 'Affiliation': 'Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA; Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, USA. Electronic address: turana@ccf.org.'}, {'ForeName': 'Andra', 'Initials': 'A', 'LastName': 'Duncan', 'Affiliation': 'Department of Cardiovascular Anesthesiology, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Leung', 'Affiliation': 'Department of Radiology, Metrohealth Hospital, Cleveland, OH, USA.'}, {'ForeName': 'Nika', 'Initials': 'N', 'LastName': 'Karimi', 'Affiliation': 'Department of Anesthesiology, University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Guangmei', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': 'Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA; Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hargrave', 'Affiliation': 'Department of Cardiovascular Anesthesiology, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Gillinov', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Trombetta', 'Affiliation': 'Department of Cardiovascular Anesthesiology, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Sabry', 'Initials': 'S', 'LastName': 'Ayad', 'Affiliation': 'Department of Regional Practice, Cleveland Clinic, Cleveland, OH, USA; Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Manal', 'Initials': 'M', 'LastName': 'Hassan', 'Affiliation': 'Department of Regional Practice, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Feider', 'Affiliation': 'Department of Anesthesia, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Howard-Quijano', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh School of Medicine and University of Pittsburgh Medical Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Ruetzler', 'Affiliation': 'Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA; Department of General Anesthesiology, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Daniel I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30631-0']
1596,32682484,"Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma (CANDOR): results from a randomised, multicentre, open-label, phase 3 study.","BACKGROUND


Lenalidomide and bortezomib frontline exposure has raised a growing need for novel treatments for patients with relapsed or refractory multiple myeloma. Carfilzomib in combination with daratumumab has shown substantial efficacy with tolerable safety in relapsed or refractory multiple myeloma in a phase 1 study. In this study, we aimed to compare the efficacy and safety of carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma.
METHODS


In this randomised, multicentre, open-label, phase 3 study, 466 patients recruited from 102 sites across North America, Europe, Australia, and Asia with relapsed or refractory multiple myeloma were randomly assigned 2:1 to carfilzomib, dexamethasone, and daratumumab (KdD) or carfilzomib and dexamethasone (Kd). All patients received twice per week carfilzomib at 56 mg/m 2  (20 mg/m 2 ; days 1 and 2 during cycle 1). Daratumumab (8 mg/kg) was administered intravenously on days 1 and 2 of cycle 1 and at 16 mg/kg weekly for the remaining doses of the first two cycles, then every 2 weeks for four cycles (cycles 3-6), and every 4 weeks thereafter. Patients received 40 mg dexamethasone weekly (20 mg for patients ≥75 years old starting on the second week). The primary endpoint was progression-free survival assessed by intention to treat. Adverse events were assessed in the safety population. This trial (NCT03158688) is registered with ClinicalTrials.gov, and is active but not recruiting.
FINDINGS


Between June 13, 2017, and June 25, 2018, 466 patients of 569 assessed for eligibility were enrolled. After median follow-up of approximately 17 months, median progression-free survival was not reached in the KdD group versus 15·8 months in the Kd group (hazard ratio 0·63; 95% CI 0·46-0·85; p=0·0027). Median treatment duration was longer in the KdD versus the Kd group (70·1 vs 40·3 weeks). Grade 3 or higher adverse events were reported in 253 (82%) patients in the KdD group and 113 (74%) patients in the Kd group. The frequency of adverse events leading to treatment discontinuation was similar in both groups (KdD, 69 [22%]; Kd, 38 [25%]).
INTERPRETATION


KdD significantly prolonged progression-free survival versus Kd in patients with relapsed or refractory multiple myeloma and was associated with a favourable benefit-risk profile.
FUNDING


Amgen.",2020,Median treatment duration was longer in the KdD versus the Kd group (70·1 vs 40·3 weeks).,"['patients with relapsed or refractory multiple myeloma', '466 patients recruited from 102 sites across North America, Europe, Australia, and Asia with relapsed or refractory multiple myeloma', 'Between June 13, 2017, and June 25, 2018, 466 patients of 569 assessed for eligibility were enrolled', 'patients with relapsed or refractory multiple myeloma (CANDOR']","['dexamethasone', 'carfilzomib, dexamethasone, and daratumumab (KdD) or carfilzomib and dexamethasone (Kd', 'carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone', 'Carfilzomib, dexamethasone, and daratumumab versus carfilzomib and dexamethasone']","['frequency of adverse events leading to treatment discontinuation', 'median progression-free survival', 'Adverse events', 'progression-free survival', 'Median treatment duration', 'efficacy and safety', 'Grade 3 or higher adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C4551538', 'cui_str': 'Plasma cell myeloma refractory'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2001856', 'cui_str': 'carfilzomib'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}]",466.0,0.106024,Median treatment duration was longer in the KdD versus the Kd group (70·1 vs 40·3 weeks).,"[{'ForeName': 'Meletios', 'Initials': 'M', 'LastName': 'Dimopoulos', 'Affiliation': 'National and Kapodistrian University Athens School of Medicine, Athens, Greece.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""University of Melbourne, St Vincent's Hospital, Fitzroy, VIC, Australia.""}, {'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Cancer Research Center, University Hospital Salamanca-Instituto de Investigación Biomédica de Salamanca, Salamanca, Spain.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Landgren', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Leleu', 'Affiliation': 'Department of Hematology, CHU la Miletrie and Inserm CIC 1402, Poitiers, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Siegel', 'Affiliation': 'John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ, USA.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Zandra', 'Initials': 'Z', 'LastName': 'Klippel', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Zahlten-Kumeli', 'Affiliation': 'Amgen, Thousand Oaks, CA, USA.'}, {'ForeName': 'Saad Z', 'Initials': 'SZ', 'LastName': 'Usmani', 'Affiliation': 'Atrium Health, Charlotte, NC, USA. Electronic address: usmani@atriumhealth.org.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30734-0']
1597,32057125,Sleep Deprivation Affects Tau Phosphorylation in Human Cerebrospinal Fluid.,"Tau hyperphosphorylation is an early step in tau-mediated neurodegeneration and is associated with intracellular aggregation of tau as neurofibrillary tangles, neuronal and synaptic loss, and eventual cognitive dysfunction in Alzheimer disease. Sleep loss increases the cerebrospinal fluid concentration of amyloid-β and tau. Using mass spectrometry, we measured tau and phosphorylated tau concentrations in serial samples of cerebrospinal fluid collected from participants who were sleep-deprived, treated with sodium oxybate, or allowed to sleep normally. We found that sleep loss affected phosphorylated tau differently depending on the modified site. These findings suggest a mechanism for sleep loss to increase risk of Alzheimer disease. ANN NEUROL 2020;87:700-709.",2020,Sleep loss increases the cerebrospinal fluid concentration of amyloid-β and tau.,['Human Cerebrospinal Fluid'],"['sodium oxybate', 'Tau hyperphosphorylation']",[],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}]","[{'cui': 'C0037537', 'cui_str': 'Sodium Oxybate'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]",[],,0.0858229,Sleep loss increases the cerebrospinal fluid concentration of amyloid-β and tau.,"[{'ForeName': 'Nicolas R', 'Initials': 'NR', 'LastName': 'Barthélemy', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Kotzbauer', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Randall J', 'Initials': 'RJ', 'LastName': 'Bateman', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, MO.'}, {'ForeName': 'Brendan P', 'Initials': 'BP', 'LastName': 'Lucey', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, St Louis, MO.'}]",Annals of neurology,['10.1002/ana.25702']
1598,32701836,"Efficacy and safety of propranolol for treatment of temporomandibular disorder pain: a randomized, placebo-controlled clinical trial.","Propranolol is a nonselective beta-adrenergic receptor antagonist. A multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 2b trial enrolled participants aged 18 to 65 years with temporomandibular disorder myalgia to evaluate efficacy and safety of propranolol compared with placebo in reducing facial pain. Participants were randomized 1:1 to either extended-release propranolol hydrochloride (60 mg, BID) or placebo. The primary endpoint was change in facial pain index (FPI = facial pain intensity multiplied by facial pain duration, divided by 100). Efficacy was analyzed as a mean change in FPI from randomization to week 9 and as the proportion of participants with ≥30% or ≥50% reductions in FPI at week 9. Regression models tested for treatment-group differences adjusting for study site, sex, race, and FPI at randomization. Of 299 participants screened, 200 were randomized; 199 had at least one postrandomization FPI measurement and were included in intention-to-treat analysis. At week 9, model-adjusted reductions in mean FPI did not differ significantly between treatment groups (-1.8, 95% CL: -6.2, 2.6; P = 0.41). However, the proportion with a ≥30% reduction in FPI was significantly greater for propranolol (69.0%) than placebo (52.6%), and the associated number-needed-to-treat was 6.1 (P = 0.03). Propranolol was likewise efficacious for a ≥50% reduction in FPI (number-needed-to-treat = 6.1, P = 0.03). Adverse event rates were similar between treatment groups, except for more frequent fatigue, dizziness, and sleep disorder in the propranolol group. Propranolol was not different from placebo in reducing mean FPI but was efficacious in achieving ≥30% and ≥50% FPI reductions after 9 weeks of treatment among temporomandibular disorder participants.",2020,"Adverse event rates were similar between treatment groups, except for more frequent fatigue, dizziness, and sleep disorder in the propranolol group.","['temporomandibular disorder pain', '299 participants screened, 200 were randomized; 199 had at least one postrandomization FPI measurement and were included in intention-to-treat analysis', 'participants aged 18 to 65 years with temporomandibular disorder myalgia', 'temporomandibular disorder participants']","['Propranolol', 'extended-release propranolol hydrochloride', 'propranolol', 'placebo']","['frequent fatigue, dizziness, and sleep disorder', 'FPI', 'facial pain index (FPI = facial pain intensity multiplied by facial pain duration, divided by 100', 'Efficacy and safety', 'Adverse event rates', 'Efficacy', 'mean change in FPI', 'mean FPI', 'facial pain']","[{'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}]","[{'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0282321', 'cui_str': 'Propranolol hydrochloride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1719797', 'cui_str': 'Multiply'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",200.0,0.579533,"Adverse event rates were similar between treatment groups, except for more frequent fatigue, dizziness, and sleep disorder in the propranolol group.","[{'ForeName': 'Inna E', 'Initials': 'IE', 'LastName': 'Tchivileva', 'Affiliation': 'Center for Pain Research and Innovation, Adams School of Dentistry, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Hadgraft', 'Affiliation': 'Rho Inc, Durham, NC, United States.'}, {'ForeName': 'Pei Feng', 'Initials': 'PF', 'LastName': 'Lim', 'Affiliation': 'Center for Pain Research and Innovation, Adams School of Dentistry, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Di Giosia', 'Affiliation': 'Center for Pain Research and Innovation, Adams School of Dentistry, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Margarete', 'Initials': 'M', 'LastName': 'Ribeiro-Dasilva', 'Affiliation': 'Department of Community Dentistry & Behavioral Science, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Campbell', 'Affiliation': 'Departments of Oral and Maxillofacial Surgery and.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Willis', 'Affiliation': 'Rho Inc, Durham, NC, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'James', 'Affiliation': 'Rho Inc, Durham, NC, United States.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Herman-Giddens', 'Affiliation': 'Rho Inc, Durham, NC, United States.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Fillingim', 'Affiliation': 'Department of Community Dentistry & Behavioral Science, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ohrbach', 'Affiliation': 'Oral Diagnostic Sciences, University at Buffalo, State University of New York, Buffalo, NY, United States.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Arbes', 'Affiliation': 'Rho Inc, Durham, NC, United States.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Slade', 'Affiliation': 'Center for Pain Research and Innovation, Adams School of Dentistry, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}]",Pain,['10.1097/j.pain.0000000000001882']
1599,32701843,Enhanced mindfulness-based stress reduction in episodic migraine: a randomized clinical trial with magnetic resonance imaging outcomes.,"We aimed to evaluate the efficacy of an enhanced mindfulness-based stress reduction (MBSR+) vs stress management for headache (SMH). We performed a randomized, assessor-blind, clinical trial of 98 adults with episodic migraine recruited at a single academic center comparing MBSR+ (n = 50) with SMH (n = 48). MBSR+ and SMH were delivered weekly by group for 8 weeks, then biweekly for another 8 weeks. The primary clinical outcome was reduction in headache days from baseline to 20 weeks. Magnetic resonance imaging (MRI) outcomes included activity of left dorsolateral prefrontal cortex (DLPFC) and cognitive task network during cognitive challenge, resting state connectivity of right dorsal anterior insula to DLPFC and cognitive task network, and gray matter volume of DLPFC, dorsal anterior insula, and anterior midcingulate. Secondary outcomes were headache-related disability, pain severity, response to treatment, migraine days, and MRI whole-brain analyses. Reduction in headache days from baseline to 20 weeks was greater for MBSR+ (7.8 [95% CI, 6.9-8.8] to 4.6 [95% CI, 3.7-5.6]) than for SMH (7.7 [95% CI 6.7-8.7] to 6.0 [95% CI, 4.9-7.0]) (P = 0.04). Fifty-two percent of the MBSR+ group showed a response to treatment (50% reduction in headache days) compared with 23% in the SMH group (P = 0.004). Reduction in headache-related disability was greater for MBSR+ (59.6 [95% CI, 57.9-61.3] to 54.6 [95% CI, 52.9-56.4]) than SMH (59.6 [95% CI, 57.7-61.5] to 57.5 [95% CI, 55.5-59.4]) (P = 0.02). There were no differences in clinical outcomes at 52 weeks or MRI outcomes at 20 weeks, although changes related to cognitive networks with MBSR+ were observed. Enhanced mindfulness-based stress reduction is an effective treatment option for episodic migraine.",2020,"There were no differences in clinical outcomes at 52 weeks or MRI outcomes at 20 weeks, although changes related to cognitive networks with MBSR+ were observed.","['headache (SMH', '98 adults with episodic migraine recruited at a single academic center comparing MBSR+ (n = 50) with SMH (n = 48', 'episodic migraine']","['Magnetic resonance imaging (MRI', 'enhanced mindfulness-based stress reduction (MBSR', 'MBSR+ and SMH', 'SMH', 'MBSR']","['headache days', 'reduction in headache days', 'headache-related disability', 'headache-related disability, pain severity, response to treatment, migraine days, and MRI whole-brain analyses', 'MBSR', 'activity of left dorsolateral prefrontal cortex (DLPFC) and cognitive task network during cognitive challenge, resting state connectivity of right dorsal anterior insula to DLPFC and cognitive task network, and gray matter volume of DLPFC, dorsal anterior insula, and anterior midcingulate']","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0018681', 'cui_str': 'Headache'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0228259', 'cui_str': 'Anterior insula'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}]",98.0,0.12879,"There were no differences in clinical outcomes at 52 weeks or MRI outcomes at 20 weeks, although changes related to cognitive networks with MBSR+ were observed.","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Seminowicz', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Shana A B', 'Initials': 'SAB', 'LastName': 'Burrowes', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kearson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Krimmel', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Luma', 'Initials': 'L', 'LastName': 'Samawi', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Furman', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Keaser', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Neda F', 'Initials': 'NF', 'LastName': 'Gould', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Trish', 'Initials': 'T', 'LastName': 'Magyari', 'Affiliation': 'Private Mindfulness-based Psychotherapy Practice, Baltimore, MD, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'White', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Goloubeva', 'Affiliation': 'University of Maryland Greenebaum Comprehensive Cancer Center, University of Maryland Baltimore, Baltimore, MD, United States.'}, {'ForeName': 'Madhav', 'Initials': 'M', 'LastName': 'Goyal', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'B Lee', 'Initials': 'BL', 'LastName': 'Peterlin', 'Affiliation': 'Neuroscience Institute, Penn Medicine Lancaster General Health, Lancaster, PA, United States.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Haythornthwaite', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}]",Pain,['10.1097/j.pain.0000000000001860']
1600,32701846,Placebo hypoalgesia: racial differences.,"No large-cohort studies that examine potential racial effects on placebo hypoalgesic effects exist. To fill this void, we studied placebo effects in healthy and chronic pain participants self-identified as either African American/black (AA/black) or white. We enrolled 372 study participants, 186 with a diagnosis of temporomandibular disorder (TMD) and 186 race-, sex-, and age-matched healthy participants to participate in a placebo experiment. Using a well-established paradigm of classical conditioning with verbal suggestions, each individual pain sensitivity was measured to calibrate the temperatures for high- and low-pain stimuli in the conditioning protocol. These 2 temperatures were then paired with a red and green screen, respectively, and participants were told that the analgesic intervention would activate during the green screens to reduce pain. Participants then rated the painfulness of each stimulus on a visual analog scale ranging from 0 to 100. Racial influences were tested on conditioning strength, reinforced expectations, and placebo hypoalgesia. We found that white participants reported greater conditioning effects, reinforced relief expectations, and placebo effects when compared with their AA/black counterparts. Racial effects on placebo were observed in TMD, although negligible, short-lasting, and mediated by conditioning strength. Secondary analyses on the effect of experimenter-participant race and sex concordance indicated that same experimenter-participant race induced greater placebo hypoalgesia in TMDs while different sex induced greater placebo hypoalgesia in healthy participants. This is the first and largest study to analyze racial effects on placebo hypoalgesia and has implications for both clinical research and treatment outcomes.",2020,Secondary analyses on the effect of experimenter-participant race and sex concordance indicated that same experimenter-participant race induced greater placebo hypoalgesia in TMDs while different sex induced greater placebo hypoalgesia in healthy participants.,"['healthy and chronic pain participants self-identified as either African American/black (AA/black) or white', 'We enrolled 372 study participants, 186 with a diagnosis of temporomandibular disorder (TMD) and 186 race-, sex-, and age-matched healthy participants to participate in a placebo experiment', 'healthy participants']","['Placebo', 'placebo']",[],"[{'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],372.0,0.217704,Secondary analyses on the effect of experimenter-participant race and sex concordance indicated that same experimenter-participant race induced greater placebo hypoalgesia in TMDs while different sex induced greater placebo hypoalgesia in healthy participants.,"[{'ForeName': 'Chika', 'Initials': 'C', 'LastName': 'Okusogu', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Titilola', 'Initials': 'T', 'LastName': 'Akintola', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Nathaniel R', 'Initials': 'NR', 'LastName': 'Haycock', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Raghuraman', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Greenspan', 'Affiliation': 'Center to Advance Chronic Pain Research, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Department of Neural and Pain Sciences and Brotman Facial Pain Clinic, School of Dentistry, Baltimore, MD, United States.'}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Dorsey', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, United States.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain and Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, United States.'}]",Pain,['10.1097/j.pain.0000000000001876']
1601,32706652,Changes in Patient-Reported Outcome Measures With a Technology-Supported Behavioral Lifestyle Intervention Among Patients With Type 2 Diabetes: Pilot Randomized Controlled Clinical Trial.,"BACKGROUND


In the United States, more than one-third of the adult population is obese, and approximately 25.2% of those aged ≥65 years have type 2 diabetes (T2D), which is the seventh leading cause of death. It is important to measure patient-reported outcomes and monitor progress or challenges over time when managing T2D to understand patients' perception of health and quantify the impact of disease processes or intervention effects. The evaluation of patient-reported outcome measures (PROMs) is especially important among patients with multiple chronic conditions in which clinical measures do not provide a complete picture of health.
OBJECTIVE


This study examined the feasibility of collecting Patient-Reported Outcome Measurement Information System (PROMIS) measures, and preliminarily evaluated changes in PROMIS scores and compared the scores with standard scores of the general US population. The parent study is a pilot randomized controlled clinical trial testing three different modes (mobile health [mHealth], paper diary, and control) of self-monitoring in a behavioral lifestyle intervention among overweight or obese patients with T2D.
METHODS


Patients with comorbid overweight or obesity and a diagnosis of T2D for at least 6 months were recruited from a diabetes education program. Participants were randomized to the following three groups: mHealth, paper diary, and control (standard of care) groups. Paper diary and mHealth experimental groups received additional behavioral lifestyle intervention education sessions, as well as tools to self-monitor weight, physical activity, diet, and blood glucose. All participants completed PROMIS-57 and PROMIS-Global Health (GH) version 1.0 questionnaires during visits at baseline, 3 months, and 6 months. The PROMIS-57 includes the following seven domains: anxiety, depression, fatigue, pain interference, physical function, satisfaction with participation in social roles, and sleep disturbance. The PROMIS-GH is composed of the following two domains: global mental health and global physical health.
RESULTS


A total of 26 patients (mHealth, 11; paper diary, 9; control, 6) were included in our analysis. The study sample was predominantly African American (68%) and female (57%), with a mean age of 54.7 years and a mean BMI of 37.5 kg/m 2 . All patients completed the PROMIS-57 and PROMIS-GH questionnaires, and we compared the mean scores of the three groups to investigate potential differences. No relevant differences were noted across the groups. However, positive trends were noted in both intervention (mHealth and paper diary) groups in the middle (month 3) and end (month 6) of the study.
CONCLUSIONS


Our pilot study provides evidence for the feasibility of using PROMIS questionnaires to record important components of T2D-related symptoms among overweight or obese individuals. The results from our study support the use of PROMIS questionnaires to provide clinicians and researchers with a benchmark for assessing the overall need for symptom management and determining the success or challenges of an intervention.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02858648; https://clinicaltrials.gov/ct2/show/NCT02858648.",2020,No relevant differences were noted across the groups.,"['overweight or obese patients with T2D.\nMETHODS\n\n\nPatients with comorbid overweight or obesity and a diagnosis of T2D for at least 6 months were recruited from a diabetes education program', 'The study sample was predominantly African American (68%) and female (57%), with a mean age of 54.7 years and a mean BMI of 37.5 kg/m 2 ', 'overweight or obese individuals', '26 patients (mHealth, 11; paper diary, 9; control, 6) were included in our analysis', 'Patients With Type']","['additional behavioral lifestyle intervention education sessions', 'Technology-Supported Behavioral Lifestyle Intervention', 'modes (mobile health [mHealth], paper diary, and control) of self-monitoring in a behavioral lifestyle intervention']","['anxiety, depression, fatigue, pain interference, physical function, satisfaction with participation in social roles, and sleep disturbance']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517742', 'cui_str': '37.5'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}]",6.0,0.0698373,No relevant differences were noted across the groups.,"[{'ForeName': 'Rozmin', 'Initials': 'R', 'LastName': 'Jiwani', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Berndt', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Padmavathy', 'Initials': 'P', 'LastName': 'Ramaswamy', 'Affiliation': 'Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, United States.'}, {'ForeName': 'Nitha', 'Initials': 'N', 'LastName': 'Mathew Joseph', 'Affiliation': 'Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, United States.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Jisook', 'Initials': 'J', 'LastName': 'Ko', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Espinoza', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, TX, United States.'}]",JMIR diabetes,['10.2196/19268']
1602,32706738,User Engagement Among Diverse Adults in a 12-Month Text Message-Delivered Diabetes Support Intervention: Results from a Randomized Controlled Trial.,"BACKGROUND


Text message-delivered interventions are a feasible and scalable approach for improving chronic disease self-care and reducing health disparities; however, information on long-term user engagement with these interventions is limited.
OBJECTIVE


The aim of this study is to examine user engagement in a 12-month text message-delivered intervention supporting diabetes self-care, called REACH (Rapid Education/Encouragement And Communications for Health), among racially and socioeconomically diverse patients with type 2 diabetes (T2D). We explored time trends in engagement, associations between patient characteristics and engagement, and whether the addition of a human component or allowing patients to change their text frequency affected engagement. Qualitative data informed patients' subjective experience of their engagement.
METHODS


We recruited patients with T2D for a randomized trial evaluating mobile phone support relative to enhanced treatment as usual. This analysis was limited to participants assigned to the intervention. Participants completed a survey and hemoglobin A1c (HbA1c) test and received REACH text messages, including self-care promotion texts, interactive texts asking about medication adherence, and adherence feedback texts. For the first 6 months, texts were sent daily, and half of the participants also received monthly phone coaching. After 6 months, coaching stopped, and participants had the option to receive fewer texts for the subsequent 6 months. We defined engagement via responses to the interactive texts and responses to a follow-up interview. We used regression models to analyze associations with response rate and thematic and structural analysis to understand participants' reasons for responding to the texts and their preferred text frequency.
RESULTS


The participants were, on average, aged 55.8 (SD 9.8) years, 55.2% (137/248) female, and 52.0% (129/248) non-White; 40.7% (101/248) had ≤ a high school education, and 40.7% (101/248) had an annual household income <US $25,000. The median response rate to interactive texts was 91% (IQR 75%-97%) over 12 months. Engagement gradually declined throughout the intervention but remained high. Engagement did not differ by age, gender, education, income, diabetes duration, insulin status, health literacy, or numeracy. Black race and worse baseline medication adherence and HbA1c were each associated with lower engagement, although the effects were small. Nearly half of the participants chose to continue receiving daily texts for the last 6 months of the intervention. Participants who continued daily text messages said they wanted to continue experiencing benefits to their health, whereas those who chose fewer texts said that the daily texts had helped them create routines and they no longer needed them as often. Engagement was not impacted by receiving coaching or by participants' chosen text frequency.
CONCLUSIONS


Well-designed interactive text messages can engage diverse patients in a self-care intervention for at least 1 year. Variation in and reasons for frequency preference suggest that offering a frequency choice may be important to users' engagement.",2020,"Black race and worse baseline medication adherence and HbA1c were each associated with lower engagement, although the effects were small.","['participants were, on average, aged 55.8 (SD 9.8) years, 55.2% (137/248) female, and 52.0% (129/248) non-White; 40.7% (101/248) had ≤ a high school education, and 40.7% (101/248) had an annual household income', 'racially and socioeconomically diverse patients with type 2 diabetes (T2D']","['monthly phone coaching', 'Text Message-Delivered Diabetes Support Intervention', 'REACH text messages, including self-care promotion texts, interactive texts asking about medication adherence, and adherence feedback texts', 'text message-delivered intervention supporting diabetes self-care, called REACH (Rapid Education/Encouragement And Communications for Health']","['median response rate to interactive texts', 'age, gender, education, income, diabetes duration, insulin status, health literacy, or numeracy']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0557163', 'cui_str': 'Household income'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]",,0.0979734,"Black race and worse baseline medication adherence and HbA1c were each associated with lower engagement, although the effects were small.","[{'ForeName': 'Lyndsay A', 'Initials': 'LA', 'LastName': 'Nelson', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spieker', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Greevy', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'LeStourgeon', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Wallston', 'Affiliation': 'Institute for Medicine and Public Health, Vanderbilt University Medical Center, Nashville, TN, United States.'}, {'ForeName': 'Lindsay S', 'Initials': 'LS', 'LastName': 'Mayberry', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, United States.'}]",JMIR mHealth and uHealth,['10.2196/17534']
1603,32706741,Extended Support Within a Person-Centered Practice After Surgery for Patients With Pituitary Tumors: Protocol for a Quasiexperimental Study.,"BACKGROUND


Patients with pituitary tumors often live with lifelong consequences of their disease. Treatment options include surgery, radiotherapy, and medical therapy. Symptoms associated with the tumor or its treatment affect several areas of life. Patients need to adhere to long-term contact with both specialist and general health care providers due to the disease, complex treatments, and associated morbidity. The first year after pituitary surgery constitutes an important time period, with medical evaluations after surgery and decisions on hormonal substitution. The development and evaluation of extended patient support during this time are limited.
OBJECTIVE


The aim of this study is to evaluate whether support within a person-centered care practice increases wellbeing for patients with pituitary tumors. Our main hypothesis is that the extended support will result in increased psychological wellbeing compared with the support given within standard of care. Secondary objectives are to evaluate whether the extended support, compared with standard care, will result in (1) better health status, (2) less fatigue, (3) higher satisfaction with care, (4) higher self-efficacy, (5) increased person-centered content in care documentation, and (6) sustained patient safety.
METHODS


Within a quasiexperimental design, patients diagnosed with a pituitary tumor planned for neurosurgery are consecutively included in a pretest-posttest study performed at a specialist endocrine clinic. The control group receives standard of care after surgery, and the interventional group receives structured patient support for 1 year after surgery based on person-centeredness covering self-management support, accessibility, and continuity. A total of 90 patients are targeted for each group.
RESULTS


Recruitment into the control group was performed between Q3 2015 and Q4 2017. Recruitment into the intervention group started in Q4 2017 and is ongoing until Q4 2020. The study is conducted according to the Declaration of Helsinki, and the protocol has received approval from a regional ethical review board.
CONCLUSIONS


This study entails an extensive intervention constructed in collaboration between clinicians, patients, and researchers that acknowledges accessibility, continuity, and self-management support within person-centeredness. The study has the potential to compare standard care to person-centered practice adapted specifically for patients with pituitary tumors and evaluated with a combination of patient-reported outcomes and patient-reported experience measures. Following the results, the person-centered practice may also become a useful model to further develop and explore person-centered care for patients with other rare, lifelong conditions.
TRIAL REGISTRATION


Researchweb.org. https://www.researchweb.org/is/sverige/project/161671.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/17697.",2020,"Secondary objectives are to evaluate whether the extended support, compared with standard care, will result in (1) better health status, (2) less fatigue, (3) higher satisfaction with care, (4) higher self-efficacy, (5) increased person-centered content in care documentation, and (6) sustained patient safety.
","['patients diagnosed with a pituitary tumor planned for neurosurgery are consecutively included in a pretest-posttest study performed at a specialist endocrine clinic', '90 patients are targeted for each group', 'Patients with pituitary tumors often live with lifelong consequences of their disease', 'patients with pituitary tumors', 'Patients With Pituitary Tumors']","['standard of care after surgery, and the interventional group receives structured patient support for 1 year after surgery based on person-centeredness covering self-management support, accessibility, and continuity', 'support within a person-centered care practice', 'surgery, radiotherapy, and medical therapy']","['result in (1) better health status, (2) less fatigue, (3) higher satisfaction with care, (4) higher self-efficacy, (5) increased person-centered content in care documentation, and (6) sustained patient safety', 'psychological wellbeing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032019', 'cui_str': 'Neoplasm of pituitary gland'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0027926', 'cui_str': 'Neurosurgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",,0.0604903,"Secondary objectives are to evaluate whether the extended support, compared with standard care, will result in (1) better health status, (2) less fatigue, (3) higher satisfaction with care, (4) higher self-efficacy, (5) increased person-centered content in care documentation, and (6) sustained patient safety.
","[{'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Jakobsson', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Olsson', 'Affiliation': 'Department of Medicine, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Department of Medicine, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Hallén', 'Affiliation': 'Department of Neurosurgery, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krabbe', 'Affiliation': 'Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Ann-Charlotte', 'Initials': 'AC', 'LastName': 'Olofsson', 'Affiliation': 'Department of Medicine, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Ragnarsson', 'Affiliation': 'Department of Medicine, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Skoglund', 'Affiliation': 'Department of Neurosurgery, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Gudmundur', 'Initials': 'G', 'LastName': 'Johannsson', 'Affiliation': 'Department of Medicine, Sahlgrenska University Hospital, Region Västra Götaland, Gothenburg, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Jakobsson Ung', 'Affiliation': 'Institute of Health and Care Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",JMIR research protocols,['10.2196/17697']
1604,32678485,Endoscopic trans gluteal minimal-invasive approach for nerve liberation (ENTRAMI technique) in case of pudendal and/or cluneal neuralgia by entrapment: One-year follow-up.,"BACKGROUND


Chronic neuropathic perineal pain syndrome is a collective term that encompasses several diagnoses. In patients where the neuropathic pain syndrome is caused by pudendal or cluneal nerve entrapment, surgical release can be proposed if other measures have failed. The aim of this study is to evaluate the clinical outcome of patients suffering from pudendal and/or cluneal nerve entrapment at 1 year after this minimal invasive surgery, which is based on the open trans gluteal approach who has proven its efficacy compared to medical treatment in a randomized control trial.
METHODS


Patients eligible for inclusion had chronic perineal neuropathic pain for at least 3 months in the area served by the pudendal and/or cluneal nerve, refractory to conservative measurements. Patients met all five of the Nantes criteria.
RESULTS


Fifteen patients underwent the ENTRAMI technique. At 1 year after surgery, overall reduction of the average maximal Numeric Pain rating Scale (NPRS-score) was from 9 (range, 7-10) at baseline to 5 (range, 0-10; P-value <.05). At 1 year 73% of patients declared to have a ""good treatment response"" (patient global impression of change [PGIC] >30%) and optimal treatment response (PGIC ≥90%) was found in 40% (P-value <.05). No complications were recorded.
CONCLUSION


This study clearly shows that the technique is feasible with promising long-term results in a difficult to manage patient group.",2020,"At 1 year after surgery, overall reduction of the average maximal Numeric Pain rating Scale (NPRS-score) was from 9 (range, 7-10) at baseline to 5 (range, 0-10; P-value <.05).","['Patients met all five of the Nantes criteria', 'patients suffering from pudendal and/or cluneal nerve entrapment at 1 year after this minimal invasive surgery', 'Fifteen patients underwent the ENTRAMI technique', 'Chronic neuropathic perineal pain syndrome', 'case of pudendal and/or cluneal neuralgia by entrapment', 'Patients eligible for inclusion had chronic perineal neuropathic pain for at least 3 months in the area served by the pudendal and/or cluneal nerve, refractory to conservative measurements']",['Endoscopic trans gluteal minimal-invasive approach'],['average maximal Numeric Pain rating Scale (NPRS-score'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0917811', 'cui_str': 'Nerve Entrapment'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0235641', 'cui_str': 'Pain in female perineum'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C1285497', 'cui_str': 'Entrapment'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0031066', 'cui_str': 'Perineal'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",15.0,0.0427779,"At 1 year after surgery, overall reduction of the average maximal Numeric Pain rating Scale (NPRS-score) was from 9 (range, 7-10) at baseline to 5 (range, 0-10; P-value <.05).","[{'ForeName': 'Katleen', 'Initials': 'K', 'LastName': 'Jottard', 'Affiliation': 'Department of Surgery, Brugmann Hospital, Brussels, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Bruyninx', 'Affiliation': 'Department of Surgery, Brugmann Hospital, Brussels, Belgium.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bonnet', 'Affiliation': 'Department of Urology and Department of Anatomy, CHU Sart-Tilman, Liège, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'De Wachter', 'Affiliation': 'Department of Urology, Antwerp University Hospital, Edegem, Belgium.'}]",Neurourology and urodynamics,['10.1002/nau.24462']
1605,32674392,Benefits and Costs of a Community-Led Total Sanitation Intervention in Rural Ethiopia-A Trial-Based ex post Economic Evaluation.,"We estimated the costs and benefits of a community-led total sanitation (CLTS) intervention using the empirical results from a cluster-randomized controlled trial in rural Ethiopia. We modelled benefits and costs of the intervention over 10 years, as compared to an existing local government program. Health benefits were estimated as the value of averted mortality due to diarrheal disease and the cost of illness arising from averted diarrheal morbidity. We also estimated the value of time savings from avoided open defecation and use of neighbours' latrines. Intervention delivery costs were estimated top-down based on financial records, while recurrent costs were estimated bottom-up from trial data. We explored methodological and parameter uncertainty using one-way and probabilistic sensitivity analyses. Avoided mortality accounted for 58% of total benefits, followed by time savings from increased access to household latrines. The base case benefit-cost ratio was 3.7 (95% CI: 1.9-5.4) and the net present value was Int'l $1,193,786 (95% CI: 406,017-1,977,960). The sources of the largest uncertainty in one-way sensitivity analyses were the effect of the CLTS intervention and the assumed lifespan of an improved latrine. Our results suggest that CLTS interventions can yield favourable economic returns, particularly if follow-up after the triggering is implemented intensively and uptake of improved latrines is achieved (as opposed to unimproved).",2020,"The base case benefit-cost ratio was 3.7 (95% CI: 1.9-5.4) and the net present value was Int'l $1,193,786 (95% CI: 406,017-1,977,960).",['rural Ethiopia'],"['Community-Led Total Sanitation Intervention', 'community-led total sanitation (CLTS) intervention', 'CLTS interventions']",['Avoided mortality'],"[{'cui': 'C0015024', 'cui_str': 'Ethiopia'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.0617726,"The base case benefit-cost ratio was 3.7 (95% CI: 1.9-5.4) and the net present value was Int'l $1,193,786 (95% CI: 406,017-1,977,960).","[{'ForeName': 'Seungman', 'Initials': 'S', 'LastName': 'Cha', 'Affiliation': 'Faculty of Infectious and Tropical Disease, London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, UK.'}, {'ForeName': 'Sunghoon', 'Initials': 'S', 'LastName': 'Jung', 'Affiliation': 'Good Neighbors International, Mozambique, Maputo, Mozambique.'}, {'ForeName': 'Dawit Belew', 'Initials': 'DB', 'LastName': 'Bizuneh', 'Affiliation': 'Independent Consultant, Addis Ababa, Ethiopia.'}, {'ForeName': 'Tadesse', 'Initials': 'T', 'LastName': 'Abera', 'Affiliation': 'Public Health Institute, Addis Ababa, Ethiopia.'}, {'ForeName': 'Young-Ah', 'Initials': 'YA', 'LastName': 'Doh', 'Affiliation': 'Korea International Cooperation Agency, Seongnam 13449, Korea.'}, {'ForeName': 'Jieun', 'Initials': 'J', 'LastName': 'Seong', 'Affiliation': 'Korea International Cooperation Agency, Seongnam 13449, Korea.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ross', 'Affiliation': 'Faculty of Infectious and Tropical Disease, London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17145068']
1606,32679370,Early application of caffeine improves white matter development in very preterm infants.,"The aim of this study was to evaluate the effect of early prophylactic caffeine treatment on white matter development in very preterm infants using cerebral magnetic resonance imaging. A total of 194 preterm infants (≤32 weeks gestational age) were randomly assigned to the caffeine (n = 96) or placebo (n = 93) treatment group and administered with either caffeine or placebo within 72 h after birth. Cerebral magnetic resonance imaging, including diffuse tensor imaging examination, was performed at 34-36 weeks of corrected gestational age, and the fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values were measured. In total, 160 infants were included in the final analysis, including 80 cases in the placebo group and 80 cases in the caffeine group. There were fewer instances of apnea of prematurity and shorter assisted ventilation times for infants in the caffeine group compared to the placebo group (p < 0.05). Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group. ADC values in the above white matter areas were significantly reduced in the caffeine group. However, there were no significant differences regarding the FA and ADC in the gray matter between the two groups. These results demonstrate that early administration of caffeine improves white matter micro-structural development in preterm infants, but with no significant effect on short-term complications related to prematurity.",2020,"Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group.","['very preterm infants', 'very preterm infants using cerebral magnetic resonance imaging', 'preterm infants', '194 preterm infants (≤32 weeks gestational age', '160 infants were included in the final analysis, including 80 cases in the placebo group and 80 cases in the caffeine group']","['placebo', 'caffeine', 'caffeine or placebo', 'prophylactic caffeine']","['white matter micro-structural development', 'apnea of prematurity and shorter assisted ventilation times', 'FA values', 'fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values', 'FA and ADC', 'ADC values']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0009653', 'cui_str': 'Condom'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0475715', 'cui_str': 'Apnea of prematurity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}]",194.0,0.144528,"Infants in the caffeine group had significantly higher FA values in white matter, including the posterior limb of the internal capsule, the corpus callosum, the frontal, occipital, and parietal white matter, the cerebellum, and the cerebral peduncle, compared to infants in the placebo group.","[{'ForeName': 'Shasha', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Yanchao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Brain Imaging, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Ruili', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Brain Imaging, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Xiaoyang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China; Center for Perinatal Medicine and Health, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg 40530, Sweden.'}, {'ForeName': 'Falin', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': 'Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China.'}, {'ForeName': 'Changlian', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': ""Henan Key Laboratory of Child Brain Injury, Third Affiliated Hospital and Institute of Neuroscience, Zhengzhou University, Zhengzhou 450052, China; Center for Brain Repair and Rehabilitation, Institute of Neuroscience and Physiology, Sahlgrenska Academy, Gothenburg University, Gothenburg 40530, Sweden; Department of Women's and Children's Health, Karolinska Institutet, Stockholm 17177, Sweden. Electronic address: changlian.zhu@neuro.gu.se.""}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103495']
1607,32679403,"Commentary on Liu, K. et al. (2018). Handgrip exercise reduces peripherally-inserted central catheter-related venous thrombosis in patients with solid cancers: A randomized controlled trial.",,2020,,['patients with solid cancers'],['Handgrip exercise reduces peripherally-inserted central catheter-related venous thrombosis'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0179740', 'cui_str': 'Peripherally inserted central catheter'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}]",[],,0.162369,,"[{'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Wen', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China.'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Ying', 'Affiliation': 'Department of Nursing, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China. Electronic address: yanpingying0116@126.com.'}, {'ForeName': 'Jianpeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, The First Affiliated Hospital of Guangxi Medical University, No. 6, Shuangyong Road, 530021 Nanning, Guangxi, China.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103691']
1608,32681091,Exhausted T cell signature predicts immunotherapy response in ER-positive breast cancer.,"Responses to immunotherapy are uncommon in estrogen receptor (ER)-positive breast cancer and to date, lack predictive markers. This randomized phase II study defines safety and response rate of epigenetic priming in ER-positive breast cancer patients treated with checkpoint inhibitors as primary endpoints. Secondary and exploratory endpoints included PD-L1 modulation and T-cell immune-signatures. 34 patients received vorinostat, tamoxifen and pembrolizumab with no excessive toxicity after progression on a median of five prior metastatic regimens. Objective response was 4% and clinical benefit rate (CR + PR + SD > 6 m) was 19%. T-cell exhaustion (CD8 +  PD-1 + /CTLA-4 + ) and treatment-induced depletion of regulatory T-cells (CD4 +  Foxp3 + /CTLA-4 + ) was seen in tumor or blood in 5/5 patients with clinical benefit, but only in one non-responder. Tumor lymphocyte infiltration was 0.17%. Only two non-responders had PD-L1 expression >1%. This data defines a novel immune signature in PD-L1-negative ER-positive breast cancer patients who are more likely to benefit from immune-checkpoint and histone deacetylase inhibition (NCT02395627).",2020,"T-cell exhaustion (CD8 +  PD-1 + /CTLA-4 + ) and treatment-induced depletion of regulatory T-cells (CD4 +  Foxp3 + /CTLA-4 + ) was seen in tumor or blood in 5/5 patients with clinical benefit, but only in one non-responder.","['34 patients received', 'ER-positive breast cancer patients treated with', 'PD-L1-negative ER-positive breast cancer patients', 'ER-positive breast cancer']","['checkpoint inhibitors', 'vorinostat, tamoxifen and pembrolizumab']","['PD-L1 modulation and T-cell immune-signatures', 'clinical benefit rate', 'PD-L1 expression', 'Objective response', 'T-cell exhaustion (CD8 +\xa0 PD-1 + /CTLA-4 + ) and treatment-induced depletion of regulatory T-cells (CD4 +  Foxp3 + /CTLA-4 + ', 'Tumor lymphocyte infiltration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2938924', 'cui_str': 'Oestrogen receptor positive breast cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]","[{'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}]",34.0,0.0718826,"T-cell exhaustion (CD8 +  PD-1 + /CTLA-4 + ) and treatment-induced depletion of regulatory T-cells (CD4 +  Foxp3 + /CTLA-4 + ) was seen in tumor or blood in 5/5 patients with clinical benefit, but only in one non-responder.","[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Terranova-Barberio', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Nela', 'Initials': 'N', 'LastName': 'Pawlowska', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Mallika', 'Initials': 'M', 'LastName': 'Dhawan', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Moasser', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Chien', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Melisko', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Hope', 'Initials': 'H', 'LastName': 'Rugo', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Roshun', 'Initials': 'R', 'LastName': 'Rahimi', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Deal', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Daud', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Rosenblum', 'Affiliation': 'Department of Dermatology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Pamela N', 'Initials': 'PN', 'LastName': 'Munster', 'Affiliation': 'Division of Hematology and Oncology, University of California, San Francisco, CA, USA. pamela.munster@ucsf.edu.'}]",Nature communications,['10.1038/s41467-020-17414-y']
1609,32687974,Design and rationale for a randomized trial of a theory- and technology- enhanced physical activity intervention for Latinas: The Seamos Activas II study.,"INTRODUCTION


Latina women report disproportionately high rates of physical inactivity and related chronic health conditions. Physical activity (PA) efforts to date have shown modest success in this at-risk population; thus, more effective interventions are necessary to help Latinas reach national PA guidelines and reduce related health disparities. This paper describes the design, rationale, and baseline findings from the Seamos Activas II intervention.
METHODS/DESIGN


The ongoing RCT will test the efficacy of the Seamos Saludables PA print intervention vs. a theory-and technology-enhanced version (Seamos Activas II). The purpose of the study is to increase the percentage of Latinas meeting the national PA guidelines compared to the prior trial, improve biomarkers related to disease, and extend generalizability to a broader and more representative population of Latinas (i.e. Mexican/Mexican-Americans). Intervention refinements included further targeting key constructs of Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies. The primary outcome is change in minutes per week of MVPA measured by ActiGraph GT3X+ accelerometers at 6- and 12-months. Secondary PA outcomes assessed by the 7-Day PA Recall will be used to corroborate findings.
RESULTS


Participants (N = 199) are Latinas 18-65 years (mean = 43.8) of predominantly Mexican origin (89%). At baseline, objectively measured MVPA was 39.51 min/week (SD = 71.20, median = 10) and self-reported MVPA was 12.47 min/week (SD = 22.54, median = 0).Participants reported generally low self-efficacy and higher cognitive vs. behavioral processes of change.
CONCLUSION


Addressing interactivity and accountability through text messaging, and more rigorously targeting theoretical constructs may be key to helping Latinas achieve nationally recommended PA levels and thereby reducing health disparities.",2020,"Intervention refinements included further targeting key constructs of Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies.","['representative population of Latinas (i.e. Mexican/Mexican-Americans', 'Latina women report disproportionately high rates of physical inactivity and related chronic health conditions', 'Participants (N\u202f=\u202f199) are Latinas 18-65\u202fyears (mean\u202f=\u202f43.8) of predominantly Mexican origin (89', 'Latinas']","['Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies', 'theory- and technology- enhanced physical activity intervention']","['low self-efficacy and higher cognitive vs. behavioral processes of change', 'change in minutes per week of MVPA measured by ActiGraph GT3X+ accelerometers']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0025884', 'cui_str': 'Chicanos'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2712043', 'cui_str': 'Lacking belief in own ability'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0266557,"Intervention refinements included further targeting key constructs of Social Cognitive Theory, and incorporating interactive text message-based self-monitoring strategies.","[{'ForeName': 'Tanya J', 'Initials': 'TJ', 'LastName': 'Benitez', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America.'}, {'ForeName': 'Shira I', 'Initials': 'SI', 'LastName': 'Dunsiger', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America.'}, {'ForeName': 'Dori J', 'Initials': 'DJ', 'LastName': 'Pekmezi', 'Affiliation': 'Department of Health Behavior, School of Public Health at University of Alabama at Birmingham, Birmingham, AL, United States of America.'}, {'ForeName': 'Britta A', 'Initials': 'BA', 'LastName': 'Larsen', 'Affiliation': 'Department of Family Medicine & Public Health, University of California San Diego, La Jolla, CA, United States of America.'}, {'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Mendoza-Vasconez', 'Affiliation': 'School of Medicine, Stanford University, Stanford, CA, United States of America.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Linke', 'Affiliation': 'Department of Family Medicine & Public Health, University of California San Diego, La Jolla, CA, United States of America.'}, {'ForeName': 'Beth C', 'Initials': 'BC', 'LastName': 'Bock', 'Affiliation': 'Department of Psychiatry & Human Behavior, Alpert Medical School, Brown University, Providence, RI, United States of America.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Gans', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America; Department of Human Development and Family Studies, University of Connecticut, Storrs, CT, United States of America.'}, {'ForeName': 'Sheri J', 'Initials': 'SJ', 'LastName': 'Hartman', 'Affiliation': 'Department of Family Medicine & Public Health, University of California San Diego, La Jolla, CA, United States of America.'}, {'ForeName': 'Bess H', 'Initials': 'BH', 'LastName': 'Marcus', 'Affiliation': 'Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, United States of America. Electronic address: bess_marcus@brown.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106081']
1610,32693310,The influence of type of feedback during tablet-based delivery of intensive treatment for childhood apraxia of speech.,"PURPOSE


One of the key principles of motor learning supports using knowledge of results feedback (KR, i.e., whether a response was correct / incorrect only) during high intensity motor practice, rather than knowledge of performance (KP, i.e., whether and how a response was correct/incorrect). In the future, mobile technology equipped with automatic speech recognition (ASR) could provide KR feedback, enabling this practice to move outside the clinic, supplementing speech pathology sessions and reducing burden on already stretched speech-language pathology resources. Here, we employ a randomized controlled trial design to test the impact of KR vs KP feedback on children's response to the Nuffield Dyspraxia Programme 3, delivered through an android tablet. At the time of testing, ASR was not feasible and so correctness of responses was decided by the treating clinician.
METHOD


Fourteen children with CAS, aged 4-10 years, participated in a parallel group design, matched for age and severity of CAS. Both groups attended a university clinic for 1-hr therapy sessions 4 days a week for 3 weeks. One group received high frequency feedback comprised of both KR and KP, in the style of traditional, face-to-face intensive intervention on all days. The other group received high frequency KR + KP feedback on 1 day per week and high frequency KR feedback on the other 3 days per week, simulating the service delivery model of one clinic session per week supported by tablet-based home practice.
RESULTS


Both groups had significantly improved speech outcomes at 4-months post-treatment. Post-hoc comparisons suggested that only the KP group showed a significant change from pre- to immediately post-treatment but the group difference had dissipated by 1-month post-treatment. Heterogeneity in response to intervention within the groups suggests that other factors, not measured here, may be having a substantive influence on response to intervention and feedback type.
CONCLUSION


Mobile technology has the potential to increase motivation and engagement with therapy and to mitigate barriers associated with distance and access to speech pathology services. Further research is needed to explore the influence of type and frequency of feedback on motor learning, optimal timing for transitioning from KP to KR feedback, and how these parameters interact with task, child and context-related factors.",2020,Post-hoc comparisons suggested that only the KP group showed a significant change from pre- to immediately post-treatment but the group difference had dissipated by 1-month post-treatment.,"['childhood apraxia of speech', 'Fourteen children with CAS, aged 4-10 years, participated in a parallel group design, matched for age and severity of CAS']","['KR vs KP feedback', 'mobile technology equipped with automatic speech recognition (ASR', 'high frequency KR + KP feedback', 'high frequency feedback comprised of both KR and KP']",['speech outcomes'],"[{'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",14.0,0.0201653,Post-hoc comparisons suggested that only the KP group showed a significant change from pre- to immediately post-treatment but the group difference had dissipated by 1-month post-treatment.,"[{'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'McKechnie', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia; Faculty of Health, University of Canberra, Bruce, ACT, Australia. Electronic address: Jacqui.McKechnie@canberra.edu.au.'}, {'ForeName': 'Beena', 'Initials': 'B', 'LastName': 'Ahmed', 'Affiliation': 'Texas A&M University at Qatar, Doha, Qatar; Faculty of Engineering, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gutierrez-Osuna', 'Affiliation': 'Texas A & M University, College Station, TX, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Murray', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'McCabe', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}, {'ForeName': 'Kirrie J', 'Initials': 'KJ', 'LastName': 'Ballard', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Lidcombe, NSW, Australia.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2020.106026']
1611,32701199,"A Randomized, Double-Blind, Placebo-Controlled, Phase II Study of Regorafenib Versus Placebo in Advanced/Metastatic, Treatment-Refractory Liposarcoma: Results from the SARC024 Study.","TRIAL INFORMATION


ClinicalTrials.gov Identifier: NCT02048371 Sponsors: SARC, with support from Bayer HealthCare Pharmaceuticals (Berlin, Germany) Principal Investigator: Richard F. Riedel IRB Approved: Yes LESSONS LEARNED: The results from the liposarcoma cohort of SARC024 confirm previously published data and do not support the routine use of regorafenib in this patient population. Continued exploration of novel therapies, including combination approaches, is warranted for a patient population in whom limited treatment options exist.
BACKGROUND


Regorafenib is a multitargeted kinase inhibitor with a kinase profile overlapping, but distinct from, pazopanib, an agent approved for recurrent and metastatic non-gastrointestinal stromal tumor (GIST), non-adipocytic soft tissue sarcoma. We conducted a randomized, phase II study of regorafenib versus placebo in refractory liposarcoma patients.
METHODS


Patients with advanced or metastatic, treatment-refractory liposarcoma were randomized 1:1 to receive regorafenib 160 mg or placebo once daily (3 weeks on, 1 week off). Patients with well-differentiated liposarcoma only were excluded. Crossover for placebo was allowed upon progression. The primary endpoint was progression-free survival (PFS), according to RECIST version 1.1.
RESULTS


Forty-eight subjects with liposarcoma (34 dedifferentiated, 12 myxoid/round cell, 2 pleomorphic) were enrolled. Median PFS was 1.87 (95% confidence interval [CI], 0.92-3.67) months for regorafenib versus 2.07 (95% CI, 1.64-3.44) months for placebo; stratified hazard ratio [HR], 0.85 (95% CI, 0.46, 1.58), p = .62. No responses were seen on regorafenib. One PR was observed on placebo. Median overall survival was 6.46 (95% CI, 4.16-23.48) months for regorafenib and 4.89 (95% CI, 3.02-9.77) months for placebo, stratified HR, 0.66 (95% CI, 0.31-1.40), p = .28). Treatment-related adverse events were similar to the known safety profile of regorafenib.
CONCLUSION


Regorafenib did not appear to improve PFS in treatment-refractory liposarcoma. No new significant safety signals were observed.",2020,Median PFS was 1.87 (95% confidence interval [CI]: 0.92-3.67) months for regorafenib versus 2.07 (95% CI: 1.64-3.44) months for placebo; stratified hazard ratio [HR] 0.85,"['Advanced/Metastatic, Treatment-Refractory Liposarcoma', 'Patients with well-differentiated liposarcoma only were excluded', 'Patients with advanced/metastatic, treatment-refractory liposarcoma', 'Forty-eight subjects with liposarcoma (34 dedifferentiated, 12 myxoid/round cell, 2 pleomorphic) were enrolled', 'refractory liposarcoma patients']","['Regorafenib vs. Placebo', 'Placebo', 'regorafenib 160 mg or placebo', 'Regorafenib', 'regorafenib versus placebo', 'placebo']","['Median overall survival', 'Median PFS', 'PFS', 'progression-free survival (PFS), according to RECIST version 1.1']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0023827', 'cui_str': 'Liposarcoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0205295', 'cui_str': 'Myxoid'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}]",48.0,0.650568,Median PFS was 1.87 (95% confidence interval [CI]: 0.92-3.67) months for regorafenib versus 2.07 (95% CI: 1.64-3.44) months for placebo; stratified hazard ratio [HR] 0.85,"[{'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Riedel', 'Affiliation': 'Duke Cancer Institute, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Karla V', 'Initials': 'KV', 'LastName': 'Ballman', 'Affiliation': 'Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Weill Cornell Medicine, New York, New York, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Attia', 'Affiliation': 'Mayo Clinic, Jacksonville, Florida, USA.'}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Loggers', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.'}, {'ForeName': 'Kristen N', 'Initials': 'KN', 'LastName': 'Ganjoo', 'Affiliation': 'Stanford Cancer Institute, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Livingston', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, North Carolina, USA.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Chow', 'Affiliation': 'City of Hope Cancer Center, Duarte, California, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wright', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Ward', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rushing', 'Affiliation': 'Melvin and Bren Simon Cancer Center, Indiana University, Indianapolis, Indiana, USA.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Okuno', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Damon R', 'Initials': 'DR', 'LastName': 'Reed', 'Affiliation': 'H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Liebner', 'Affiliation': 'The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Vicki L', 'Initials': 'VL', 'LastName': 'Keedy', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Mascarenhas', 'Affiliation': ""Children's Hospital of Los Angeles, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.""}, {'ForeName': 'Lara E', 'Initials': 'LE', 'LastName': 'Davis', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ryan', 'Affiliation': 'Knight Cancer Institute, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Denise K', 'Initials': 'DK', 'LastName': 'Reinke', 'Affiliation': 'Sarcoma Alliance for Research through Collaboration (SARC), Ann Arbor, Michigan, USA.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Maki', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, USA.'}]",The oncologist,['10.1634/theoncologist.2020-0679']
1612,32702299,"Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial.","BACKGROUND


This is the first randomised controlled trial for assessment of the immunogenicity and safety of a candidate non-replicating adenovirus type-5 (Ad5)-vectored COVID-19 vaccine, aiming to determine an appropriate dose of the candidate vaccine for an efficacy study.
METHODS


This randomised, double-blind, placebo-controlled, phase 2 trial of the Ad5-vectored COVID-19 vaccine was done in a single centre in Wuhan, China. Healthy adults aged 18 years or older, who were HIV-negative and previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection-free, were eligible to participate and were randomly assigned to receive the vaccine at a dose of 1 × 10 11  viral particles per mL or 5 × 10 10  viral particles per mL, or placebo. Investigators allocated participants at a ratio of 2:1:1 to receive a single injection intramuscularly in the arm. The randomisation list (block size 4) was generated by an independent statistician. Participants, investigators, and staff undertaking laboratory analyses were masked to group allocation. The primary endpoints for immunogenicity were the geometric mean titres (GMTs) of specific ELISA antibody responses to the receptor binding domain (RBD) and neutralising antibody responses at day 28. The primary endpoint for safety evaluation was the incidence of adverse reactions within 14 days. All recruited participants who received at least one dose were included in the primary and safety analyses. This study is registered with ClinicalTrials.gov, NCT04341389.
FINDINGS


603 volunteers were recruited and screened for eligibility between April 11 and 16, 2020. 508 eligible participants (50% male; mean age 39·7 years, SD 12·5) consented to participate in the trial and were randomly assigned to receive the vaccine (1 × 10 11  viral particles n=253; 5 × 10 10  viral particles n=129) or placebo (n=126). In the 1 × 10 11  and 5 × 10 10  viral particles dose groups, the RBD-specific ELISA antibodies peaked at 656·5 (95% CI 575·2-749·2) and 571·0 (467·6-697·3), with seroconversion rates at 96% (95% CI 93-98) and 97% (92-99), respectively, at day 28. Both doses of the vaccine induced significant neutralising antibody responses to live SARS-CoV-2, with GMTs of 19·5 (95% CI 16·8-22·7) and 18·3 (14·4-23·3) in participants receiving 1 × 10 11  and 5 × 10 10  viral particles, respectively. Specific interferon γ enzyme-linked immunospot assay responses post vaccination were observed in 227 (90%, 95% CI 85-93) of 253 and 113 (88%, 81-92) of 129 participants in the 1 × 10 11  and 5 × 10 10  viral particles dose groups, respectively. Solicited adverse reactions were reported by 183 (72%) of 253 and 96 (74%) of 129 participants in the 1 × 10 11  and 5 × 10 10  viral particles dose groups, respectively. Severe adverse reactions were reported by 24 (9%) participants in the 1 × 10 11  viral particles dose group and one (1%) participant in the 5 × 10 10  viral particles dose group. No serious adverse reactions were documented.
INTERPRETATION


The Ad5-vectored COVID-19 vaccine at 5 × 10 10  viral particles is safe, and induced significant immune responses in the majority of recipients after a single immunisation.
FUNDING


National Key R&D Programme of China, National Science and Technology Major Project, and CanSino Biologics.",2020,"Both doses of the vaccine induced significant neutralising antibody responses to live SARS-CoV-2, with GMTs of 19·5 (95% CI 16·8-22·7) and 18·3 (14·4-23·3) in participants receiving 1 × 10 11  and 5 × 10 10  viral particles, respectively.","['single centre in Wuhan, China', 'healthy adults aged 18 years or older', '508 eligible participants (50% male; mean age 39·7 years, SD 12·5) consented to participate in the trial', 'Healthy adults aged 18 years or older, who were HIV-negative and previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection-free, were eligible to participate', '603 volunteers were recruited and screened for eligibility between April 11 and 16, 2020', 'All recruited participants who received at least one dose were included in the primary and safety analyses']","['recombinant adenovirus type-5-vectored', 'vaccine at a dose of 1\u2008×\u200810 11  viral particles per mL or 5\u2008×\u200810 10  viral particles per mL, or placebo', 'Ad5-vectored COVID-19 vaccine', 'vaccine', 'COVID-19 vaccine', 'placebo']","['serious adverse reactions', 'Specific interferon γ enzyme-linked immunospot assay responses post vaccination', 'Severe adverse reactions', 'seroconversion rates', 'incidence of adverse reactions', 'geometric mean titres (GMTs) of specific ELISA antibody responses to the receptor binding domain (RBD) and neutralising antibody responses', 'Solicited adverse reactions', 'Immunogenicity and safety', 'RBD-specific ELISA antibodies']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0457499', 'cui_str': 'Type 5'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0920508', 'cui_str': 'Enzyme linked immunospot assay'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",508.0,0.652323,"Both doses of the vaccine induced significant neutralising antibody responses to live SARS-CoV-2, with GMTs of 19·5 (95% CI 16·8-22·7) and 18·3 (14·4-23·3) in participants receiving 1 × 10 11  and 5 × 10 10  viral particles, respectively.","[{'ForeName': 'Feng-Cai', 'Initials': 'FC', 'LastName': 'Zhu', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China. Electronic address: jszfc@vip.sina.com.'}, {'ForeName': 'Xu-Hua', 'Initials': 'XH', 'LastName': 'Guan', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Yu-Hua', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'National Institute for Food and Drug Control, Dongcheng, Beijing, China.'}, {'ForeName': 'Jian-Ying', 'Initials': 'JY', 'LastName': 'Huang', 'Affiliation': 'Clinical Trial Center, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, China.'}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Hou', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Jing-Xin', 'Initials': 'JX', 'LastName': 'Li', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Bei-Fang', 'Initials': 'BF', 'LastName': 'Yang', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'National Institute for Food and Drug Control, Dongcheng, Beijing, China.'}, {'ForeName': 'Wen-Juan', 'Initials': 'WJ', 'LastName': 'Wang', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Shi-Po', 'Initials': 'SP', 'LastName': 'Wu', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Xiao-Hong', 'Initials': 'XH', 'LastName': 'Wu', 'Affiliation': 'National Institute for Food and Drug Control, Dongcheng, Beijing, China.'}, {'ForeName': 'Jun-Jie', 'Initials': 'JJ', 'LastName': 'Xu', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Si-Yue', 'Initials': 'SY', 'LastName': 'Jia', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Bu-Sen', 'Initials': 'BS', 'LastName': 'Wang', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Beijing Institute of Microbiology and Epidemiology, State Key Laboratory of Pathogen and Biosecurity, Beijing, China.'}, {'ForeName': 'Jing-Jing', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'National Institute for Food and Drug Control, Dongcheng, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China.'}, {'ForeName': 'Xiao-Ai', 'Initials': 'XA', 'LastName': 'Qian', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Hong-Xing', 'Initials': 'HX', 'LastName': 'Pan', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Hu-Dachuan', 'Initials': 'HD', 'LastName': 'Jiang', 'Affiliation': 'NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Deng', 'Affiliation': 'Hubei Provincial Center for Diseases Control and Prevention, Wuhan, China.'}, {'ForeName': 'Jin-Bo', 'Initials': 'JB', 'LastName': 'Gou', 'Affiliation': 'CanSino Biologics, Tianjin, China.'}, {'ForeName': 'Xue-Wen', 'Initials': 'XW', 'LastName': 'Wang', 'Affiliation': 'Shanghai Canming Medical Technology, Shanghai, China.'}, {'ForeName': 'Xing-Huan', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Clinical Trial Center, Zhongnan Hospital of Wuhan University, Wuhan, China. Electronic address: wangxinghuan@whu.edu.cn.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Beijing Institute of Biotechnology, Academy of Military Medical Sciences, Beijing, China. Electronic address: cw0226@foxmail.com.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31605-6']
1613,32702298,"Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial.","BACKGROUND


The pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) might be curtailed by vaccination. We assessed the safety, reactogenicity, and immunogenicity of a viral vectored coronavirus vaccine that expresses the spike protein of SARS-CoV-2.
METHODS


We did a phase 1/2, single-blind, randomised controlled trial in five trial sites in the UK of a chimpanzee adenovirus-vectored vaccine (ChAdOx1 nCoV-19) expressing the SARS-CoV-2 spike protein compared with a meningococcal conjugate vaccine (MenACWY) as control. Healthy adults aged 18-55 years with no history of laboratory confirmed SARS-CoV-2 infection or of COVID-19-like symptoms were randomly assigned (1:1) to receive ChAdOx1 nCoV-19 at a dose of 5 × 10 10  viral particles or MenACWY as a single intramuscular injection. A protocol amendment in two of the five sites allowed prophylactic paracetamol to be administered before vaccination. Ten participants assigned to a non-randomised, unblinded ChAdOx1 nCoV-19 prime-boost group received a two-dose schedule, with the booster vaccine administered 28 days after the first dose. Humoral responses at baseline and following vaccination were assessed using a standardised total IgG ELISA against trimeric SARS-CoV-2 spike protein, a muliplexed immunoassay, three live SARS-CoV-2 neutralisation assays (a 50% plaque reduction neutralisation assay [PRNT 50 ]; a microneutralisation assay [MNA 50 , MNA 80 , and MNA 90 ]; and Marburg VN), and a pseudovirus neutralisation assay. Cellular responses were assessed using an ex-vivo interferon-γ enzyme-linked immunospot assay. The co-primary outcomes are to assess efficacy, as measured by cases of symptomatic virologically confirmed COVID-19, and safety, as measured by the occurrence of serious adverse events. Analyses were done by group allocation in participants who received the vaccine. Safety was assessed over 28 days after vaccination. Here, we report the preliminary findings on safety, reactogenicity, and cellular and humoral immune responses. The study is ongoing, and was registered at ISRCTN, 15281137, and ClinicalTrials.gov, NCT04324606.
FINDINGS


Between April 23 and May 21, 2020, 1077 participants were enrolled and assigned to receive either ChAdOx1 nCoV-19 (n=543) or MenACWY (n=534), ten of whom were enrolled in the non-randomised ChAdOx1 nCoV-19 prime-boost group. Local and systemic reactions were more common in the ChAdOx1 nCoV-19 group and many were reduced by use of prophylactic paracetamol, including pain, feeling feverish, chills, muscle ache, headache, and malaise (all p<0·05). There were no serious adverse events related to ChAdOx1 nCoV-19. In the ChAdOx1 nCoV-19 group, spike-specific T-cell responses peaked on day 14 (median 856 spot-forming cells per million peripheral blood mononuclear cells, IQR 493-1802; n=43). Anti-spike IgG responses rose by day 28 (median 157 ELISA units [EU], 96-317; n=127), and were boosted following a second dose (639 EU, 360-792; n=10). Neutralising antibody responses against SARS-CoV-2 were detected in 32 (91%) of 35 participants after a single dose when measured in MNA 80  and in 35 (100%) participants when measured in PRNT 50 . After a booster dose, all participants had neutralising activity (nine of nine in MNA 80  at day 42 and ten of ten in Marburg VN on day 56). Neutralising antibody responses correlated strongly with antibody levels measured by ELISA (R 2 =0·67 by Marburg VN; p<0·001).
INTERPRETATION


ChAdOx1 nCoV-19 showed an acceptable safety profile, and homologous boosting increased antibody responses. These results, together with the induction of both humoral and cellular immune responses, support large-scale evaluation of this candidate vaccine in an ongoing phase 3 programme.
FUNDING


UK Research and Innovation, Coalition for Epidemic Preparedness Innovations, National Institute for Health Research (NIHR), NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and the German Center for Infection Research (DZIF), Partner site Gießen-Marburg-Langen.",2020,Neutralising antibody responses against SARS-CoV-2 were detected in 32 (91%) of 35 participants after a single dose when measured in MNA 80  and in 35 (100%) participants when measured in PRNT 50 .,"['n=543) or MenACWY (n=534), ten of whom were enrolled in the non-randomised', 'Between April 23 and May 21, 2020, 1077 participants were enrolled and assigned to receive either', 'Healthy adults aged 18-55 years with no history of laboratory confirmed SARS-CoV-2 infection or of COVID-19-like symptoms']","['ChAdOx1 nCoV-19 at a dose of 5', 'ChAdOx1 nCoV-19 vaccine against SARS-CoV-2', 'vaccine', 'ChAdOx1 nCoV-19 prime-boost group', 'chimpanzee adenovirus-vectored vaccine (ChAdOx1 nCoV-19) expressing the SARS-CoV-2 spike protein compared with a meningococcal conjugate vaccine (MenACWY', 'ChAdOx1 nCoV-19']","['pain, feeling feverish, chills, muscle ache, headache, and malaise (all p<0·05', 'Safety', 'Safety and immunogenicity', 'spike-specific T-cell responses', 'Neutralising antibody responses', 'antibody responses', 'safety, reactogenicity, and cellular and humoral immune responses', 'Humoral responses', 'safety, reactogenicity, and immunogenicity', 'Local and systemic reactions', 'Neutralising antibody responses against SARS-CoV-2', 'neutralising activity', 'symptomatic virologically confirmed COVID-19, and safety, as measured by the occurrence of serious adverse events']","[{'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0071973', 'cui_str': 'PRIME protocol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008111', 'cui_str': 'Pan troglodytes'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0687681', 'cui_str': 'Feeling feverish'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1077.0,0.295654,Neutralising antibody responses against SARS-CoV-2 were detected in 32 (91%) of 35 participants after a single dose when measured in MNA 80  and in 35 (100%) participants when measured in PRNT 50 .,"[{'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Folegatti', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Katie J', 'Initials': 'KJ', 'LastName': 'Ewer', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Parvinder K', 'Initials': 'PK', 'LastName': 'Aley', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Angus', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Belij-Rammerstorfer', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Bellamy', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Sagida', 'Initials': 'S', 'LastName': 'Bibi', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Bittaye', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Clutterbuck', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dold', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Saul N', 'Initials': 'SN', 'LastName': 'Faust', 'Affiliation': 'NIHR Southampton Clinical Research Facility, University Hospital Southampton NHS Foundation Trust and University of Southampton, Southampton, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Finn', 'Affiliation': 'School of Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Flaxman', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Bassam', 'Initials': 'B', 'LastName': 'Hallis', 'Affiliation': 'National Infection Service, Public Health England, Salisbury, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Heath', 'Affiliation': ""Vaccine Institute, St George's University, London, UK.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jenkin', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Rajeka', 'Initials': 'R', 'LastName': 'Lazarus', 'Affiliation': 'Department of Microbiology, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Makinson', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Minassian', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Katrina M', 'Initials': 'KM', 'LastName': 'Pollock', 'Affiliation': 'NIHR Imperial Clinical Research Facility, Imperial College London, London, UK.'}, {'ForeName': 'Maheshi', 'Initials': 'M', 'LastName': 'Ramasamy', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Snape', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Tarrant', 'Affiliation': 'Clinical Biomanufacturing Facility, University of Oxford, Oxford, UK.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Clinical Biomanufacturing Facility, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Douglas', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Adrian V S', 'Initials': 'AVS', 'LastName': 'Hill', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Gilbert', 'Affiliation': 'The Jenner Institute, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, Oxford, UK. Electronic address: andrew.pollard@paediatrics.ox.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)31604-4']
1614,32708894,"Effects of Ibuprofen Intake in Muscle Damage, Body Temperature and Muscle Power in Paralympic Powerlifting Athletes.","The aim of this study is to evaluate the effect of ingesting ibuprofen on post-workout recovery of muscle damage, body temperature and muscle power indicators in Paralympic powerlifting athletes. The study was carried out with eight Paralympic powerlifting athletes (aged 27.0 ± 5.3 years and 79.9 ± 25.5 kg of body mass) competing at the national level, with a minimum training experience of 12 months, who all submitted to two experimental conditions: Ibuprofen (2 × 00 mg) and control. The maximal isometric force of the upper limbs and rate of force development, thermography, and serum biochemical analyzes of creatine kinase, lactate dehydrogenase, aspartate aminotransferase and alanine aminotransferase were measured before, after, 24 h after and 48 h after the intervention. Maximal isometric force only decreased in the placebo condition, which increased back to baseline levels, while no substantial decline in baseline force was seen in the ibuprofen condition, although no effect for exercise condition was detected. After the exercise, the rate of force development decreased significantly for both conditions and did not exceed baseline levels again after 48 h. Muscle temperature decreased significantly at 48-h post-exercise in the placebo condition, when compared with the previous day of measurement; and deltoid muscle temperature at 48-h post-exercise was higher with the ibuprofen condition. Although the results indicate some positive effects of ibuprofen use, they do not enable a clear statement regarding its positive effects on muscle function and muscle damage. Ibuprofen seems to have caused a delay in the anti-inflammatory response following exercise.",2020,"Maximal isometric force only decreased in the placebo condition, which increased back to baseline levels, while no substantial decline in baseline force was seen in the ibuprofen condition, although no effect for exercise condition was detected.","['Paralympic powerlifting athletes', 'eight Paralympic powerlifting athletes (aged 27.0 ± 5.3 years and 79.9 ± 25.5 kg of body mass) competing at the national level, with a minimum training experience of 12 months, who all submitted to two experimental conditions', 'Paralympic Powerlifting Athletes']","['ingesting ibuprofen', 'Ibuprofen (2 × 00 mg) and control', 'ibuprofen', 'Ibuprofen']","['deltoid muscle temperature', 'Muscle temperature', 'Muscle Damage, Body Temperature and Muscle Power', 'Maximal isometric force', 'rate of force development', 'maximal isometric force of the upper limbs and rate of force development, thermography, and serum biochemical analyzes of creatine kinase, lactate dehydrogenase, aspartate aminotransferase and alanine aminotransferase']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517663', 'cui_str': '25.5'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0039810', 'cui_str': 'Thermography'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}]",,0.0728658,"Maximal isometric force only decreased in the placebo condition, which increased back to baseline levels, while no substantial decline in baseline force was seen in the ibuprofen condition, although no effect for exercise condition was detected.","[{'ForeName': 'Guacira S', 'Initials': 'GS', 'LastName': 'Fraga', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), São Cristovão, Sergipe 49100-000, Brazil.'}, {'ForeName': 'Felipe J', 'Initials': 'FJ', 'LastName': 'Aidar', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), São Cristovão, Sergipe 49100-000, Brazil.'}, {'ForeName': 'Dihogo G', 'Initials': 'DG', 'LastName': 'Matos', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GEPEPS), Federal University of Sergipe (UFS), São Cristovão, Sergipe 49100-000, Brazil.'}, {'ForeName': 'Anderson C', 'Initials': 'AC', 'LastName': 'Marçal', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), São Cristovão, Sergipe 49100-000, Brazil.'}, {'ForeName': 'Jymmys L', 'Initials': 'JL', 'LastName': 'Santos', 'Affiliation': 'Northeast Network in Biotechnology (RENORBIO), Federal University of Sergipe, Sergipe 49100-000, Brazil.'}, {'ForeName': 'Raphael F', 'Initials': 'RF', 'LastName': 'Souza', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), São Cristovão, Sergipe 49100-000, Brazil.'}, {'ForeName': 'André L', 'Initials': 'AL', 'LastName': 'Carneiro', 'Affiliation': 'Department of Physical Education, State University of Montes Claros, Minas Gerais 30000-000, Brazil.'}, {'ForeName': 'Alan B', 'Initials': 'AB', 'LastName': 'Vasconcelos', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), São Cristovão, Sergipe 49100-000, Brazil.'}, {'ForeName': 'Marzo E', 'Initials': 'ME', 'LastName': 'Da Silva-Grigoletto', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe (UFS), São Cristovão, Sergipe 49100-000, Brazil.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'van den Tillaar', 'Affiliation': 'Department of Sport Sciences and Physical Education, Nord University, 7600 Levanger, Norway.'}, {'ForeName': 'Breno T', 'Initials': 'BT', 'LastName': 'Cabral', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal 59072970, Brazil.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Reis', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), University of Trás-os-Montes and Alto Douro, 5000-412 Vila Real, Portugal.'}]",International journal of environmental research and public health,['10.3390/ijerph17145157']
1615,32706667,"An Internet-Based Psychological Intervention With a Serious Game to Improve Vitality, Psychological and Physical Condition, and Immune Function in Healthy Male Adults: Randomized Controlled Trial.","BACKGROUND


Recently, internet-based cognitive behavioral therapy (ICBT) and serious gaming interventions have been suggested to enhance accessibility to interventions and engagement in psychological interventions that aim to promote health outcomes. Few studies, however, have investigated their effectiveness in the context of simulated real-life challenges.
OBJECTIVE


We aimed to examine the effectivity of a guided ICBT combined with a serious gaming intervention in improving self-reported psychophysiological and immunological health endpoints in response to psychophysiological and immune-related challenges.
METHODS


Sixty-nine healthy men were randomly assigned to the intervention condition, receiving ICBT combined with serious gaming for 6 weeks, or the control condition, receiving no intervention. Self-reported vitality was the primary endpoint. Other self-reported psychophysiological and immunological endpoints were assessed following various challenges, including a bacillus Calmette-Guérin vaccination evoking pro-inflammatory responses, 1 and 4 weeks after the intervention period.
RESULTS


Although the intervention did not affect vitality-associated parameters, self-reported sleep problems (P=.027) and bodily sensations (P=.042) were lower directly after the intervention compared with controls. Furthermore, wellbeing (P=.024) was higher in the intervention group after the psychophysiological challenges. Although no significant group differences were found for the psychophysiological and immunological endpoints, the data provided preliminary support for increased immunoglobulin antibody responses at the follow-up time points (P<.05). Differential chemokine endpoints between conditions were observed at the end of the test day.
CONCLUSIONS


The present study provides some support for improving health endpoints with an innovative ICBT intervention. Future research should replicate and further extend the present findings by consistently including challenges and a wide range of immune parameters into the study design.
TRIAL REGISTRATION


Nederlands Trial Register NTR5610; https://www.trialregister.nl/trial/5466.",2020,"Although the intervention did not affect vitality-associated parameters, self-reported sleep problems (P=.027) and bodily sensations (P=.042) were lower directly after the intervention compared with controls.","['Sixty-nine healthy men', 'Healthy Male Adults']","['ICBT combined with serious gaming for 6 weeks, or the control condition, receiving no intervention', 'guided ICBT combined with a serious gaming intervention', 'internet-based cognitive behavioral therapy (ICBT', 'Internet-Based Psychological Intervention With a Serious Game']","['vitality-associated parameters, self-reported sleep problems', 'immunoglobulin antibody responses', 'bodily sensations']","[{'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0686751', 'cui_str': 'Well male adult'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]","[{'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0021027', 'cui_str': 'Immunoglobulin'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}]",69.0,0.0729687,"Although the intervention did not affect vitality-associated parameters, self-reported sleep problems (P=.027) and bodily sensations (P=.042) were lower directly after the intervention compared with controls.","[{'ForeName': 'Lemmy', 'Initials': 'L', 'LastName': 'Schakel', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Dieuwke S', 'Initials': 'DS', 'LastName': 'Veldhuijzen', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Henriët', 'Initials': 'H', 'LastName': 'van Middendorp', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Corine', 'Initials': 'C', 'LastName': 'Prins', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Anne M H F', 'Initials': 'AMHF', 'LastName': 'Drittij', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Vrieling', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Leo G', 'Initials': 'LG', 'LastName': 'Visser', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Tom H M', 'Initials': 'THM', 'LastName': 'Ottenhoff', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Simone A', 'Initials': 'SA', 'LastName': 'Joosten', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Andrea W M', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Institute of Psychology, Leiden University, Leiden, Netherlands.'}]",Journal of medical Internet research,['10.2196/14861']
1616,32706674,Novel Stepped Care Approach to Provide Education and Exercise Therapy for Patellofemoral Pain: Feasibility Study.,"BACKGROUND


Patellofemoral pain (PFP) impairs joint- and health-related quality of life and may be associated with knee osteoarthritis. We developed a novel, 2-phase, stepped-care approach for PFP, combining (1) self-directed web-based education and exercise therapy with (2) physiotherapist-supported education and exercise therapy. Physiotherapy sessions can be provided using 2 different modalities: face-to-face and telerehabilitation.
OBJECTIVE


This study aims to (1) determine the feasibility of our stepped-care approach, (2) explore patient-reported outcomes following self-directed web-based education and exercise therapy in people with PFP (phase 1), and (3) estimate the differences in treatment effects between face-to-face and telerehabilitation to support further education and exercise therapy (phase 2) in those who had not completely recovered following self-directed care.
METHODS


Phase 1 involved 6 weeks of self-directed web-based education and exercise therapy. Phase 2 involved random allocation to a further 12 weeks of physiotherapist-led (up to 8 sessions) education and exercise therapy delivered face-to-face or via telerehabilitation to participants who did not rate themselves as completely recovered following phase 1. Feasibility indicators of process, adherence, and participant retention were collected as primary outcomes alongside patient-reported outcomes on Global Rating of Change and knee pain, disability, knee-related quality of life, pain catastrophism, kinesiophobia, and knee self-efficacy. All participants were assessed at baseline, 6 weeks, and 18 weeks.
RESULTS


A total of 71 participants were screened to identify 35 participants with PFP to enter the study. Overall, 100% (35/35) and 88% (31/35) of the participants were followed up with at 6 and 18 weeks, respectively. In phase 1 of the study, participants accessed the My Knee Cap website for an average of 6 (7.5) days and performed the exercises for an average of 2.5 (3.6) times per week. A total of 20% (7/35) of the participants reported that they had completely recovered at 6 weeks. Furthermore, 93% (26/28) of the participants who were followed up and had not completely recovered at 6 weeks agreed to be enrolled in phase 2. No statistically significant differences were found between the face-to-face and telerehabilitation groups for any outcome. The novel stepped-care approach was associated with marked improvement or complete recovery in 40% (14/35) of the participants following phase 1 and 71% (25/35) of the participants following phase 2.
CONCLUSIONS


Self-directed web-based education and exercise therapy for people with PFP is feasible, as noted by the high rate of participant retention and home exercise adherence achieved in this study. Furthermore, 20% (7/35) of people reported complete recovery at 6 weeks. Both face-to-face and telerehabilitation physiotherapy should be considered for those continuing to seek care, as there is no difference in outcomes between these delivery modes. Determining the efficacy of the stepped-care model may help guide more efficient health care for PFP.",2020,No statistically significant differences were found between the face-to-face and telerehabilitation groups for any outcome.,"['people with PFP (phase 1', '71 participants were screened to identify 35 participants with PFP to enter the study']","['Physiotherapy sessions', 'physiotherapist-led (up to 8 sessions) education and exercise therapy delivered face-to-face or via telerehabilitation', 'Novel Stepped Care Approach to Provide Education and Exercise Therapy', 'self-directed web-based education and exercise therapy', 'Self-directed web-based education and exercise therapy', 'PFP, combining (1) self-directed web-based education and exercise therapy with (2) physiotherapist-supported education and exercise therapy']","['Global Rating of Change and knee pain, disability, knee-related quality of life, pain catastrophism, kinesiophobia, and knee self-efficacy', 'Feasibility indicators of process, adherence, and participant retention', 'My Knee Cap website']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}]",71.0,0.133706,No statistically significant differences were found between the face-to-face and telerehabilitation groups for any outcome.,"[{'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'De Oliveira Silva', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Marcella F', 'Initials': 'MF', 'LastName': 'Pazzinatto', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Crossley', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Fabio M', 'Initials': 'FM', 'LastName': 'Azevedo', 'Affiliation': 'Laboratory of Biomechanics and Motor Control, Sao Paulo State University, Presidente Prudente, Brazil.'}, {'ForeName': 'Christian J', 'Initials': 'CJ', 'LastName': 'Barton', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}]",Journal of medical Internet research,['10.2196/18584']
1617,32706681,Recruiting and Retaining Youth and Young Adults in the Policy and Communication Evaluation (PACE) Vermont Study: Randomized Controlled Trial of Participant Compensation.,"BACKGROUND


The standard approach for evaluating the effects of population-level substance use prevention efforts on youth and young adult perceptions and behaviors has been to compare outcomes across states using national surveillance data. Novel surveillance methods that follow individuals over shorter time intervals and capture awareness of substance use prevention policy and communication efforts may provide a stronger basis for their evaluation than annual cross-sectional studies.
OBJECTIVE


This study aimed to identify a combination of strategies to recruit a sample of youth and young adults sufficiently representative of the Vermont population and determine how best to retain a web-based panel of youth and young adults over a 6-month period.
METHODS


Eligible participants were Vermont residents aged 12 to 25 years who were willing to complete three 10 to 15-minute web-based surveys over a 6-month period. Recruitment was conducted via the following three main mechanisms: (1) web-based recruitment (paid and unpaid), (2) community-based recruitment through partners, and (3) participant referrals via a personalized link. Upon completion of the baseline survey, participants were randomly assigned to one of the following three retention incentive conditions: (1) guaranteed incentive (US $10), (2) lottery incentive (US $50 weekly lottery drawing), and (3) preferred method (guaranteed or lottery). Analyses examined cost per survey start by recruitment source, distribution of demographic characteristics across incentive conditions, and retention by study condition at 3-month and 6-month follow-ups.
RESULTS


Over a 10-week period in 2019, we recruited 480 eligible youth (aged 12-17 years) and 1037 eligible young adults (aged 18-25 years) to the Policy and Communication Evaluation (PACE) Vermont Study. Facebook and Instagram advertising produced the greatest number of survey starts (n=2013), followed by posts to a state-wide web-based neighborhood forum (n=822) and Google advertisements (n=749). Retention was 78.11% (1185/1517) at 3 months and 72.18% (1095/1517) at 6 months. Retention was equivalent across all incentive study conditions at both waves, despite a strong stated preference among study participants for the guaranteed payment at baseline. Youth had greater retention than young adults at both waves (wave 2: 395/480, 82.3% vs 790/1037, 76.18%; wave 3: 366/480, 76.3% vs 729/1037, 70.30%). Substance use prevalence in this cohort was similar to national and state-level surveillance estimates for young adults, but was lower than state-level surveillance estimates for youth. Most participants retained at wave 3 provided positive qualitative feedback on their experience.
CONCLUSIONS


Our study supports the feasibility of recruiting a web-based cohort of youth and young adults with representation across an entire state to evaluate substance use prevention efforts. Findings suggest that a guaranteed payment immediately upon survey completion coupled with a bonus for completing all survey waves and weekly survey reminders may facilitate retention in a cohort of youth and young adults.",2020,Retention was 78.11% (1185/1517) at 3 months and 72.18% (1095/1517) at 6 months.,"['Eligible participants were Vermont residents aged 12 to 25 years who were willing to complete three 10 to 15-minute web-based surveys over a 6-month period', '480 eligible youth (aged 12-17 years) and 1037 eligible young adults (aged 18-25 years) to the Policy and Communication Evaluation (PACE) Vermont Study']","['retention incentive conditions: (1) guaranteed incentive (US $10), (2) lottery incentive (US $50 weekly lottery drawing), and (3) preferred method (guaranteed or lottery']",['Retention'],"[{'cui': 'C0042537', 'cui_str': 'Vermont'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",,0.157918,Retention was 78.11% (1185/1517) at 3 months and 72.18% (1095/1517) at 6 months.,"[{'ForeName': 'Andrea C', 'Initials': 'AC', 'LastName': 'Villanti', 'Affiliation': 'Department of Psychiatry, Vermont Center on Behavior and Health, University of Vermont Larner College of Medicine, Burlington, VT, United States.'}, {'ForeName': 'Christie P', 'Initials': 'CP', 'LastName': 'Vallencourt', 'Affiliation': 'Health Promotion & Disease Prevention, Vermont Department of Health, Burlington, VT, United States.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'West', 'Affiliation': 'Department of Psychiatry, Vermont Center on Behavior and Health, University of Vermont Larner College of Medicine, Burlington, VT, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Peasley-Miklus', 'Affiliation': 'Department of Psychiatry, Vermont Center on Behavior and Health, University of Vermont Larner College of Medicine, Burlington, VT, United States.'}, {'ForeName': 'S Elisha', 'Initials': 'SE', 'LastName': 'LePine', 'Affiliation': 'Department of Psychiatry, Vermont Center on Behavior and Health, University of Vermont Larner College of Medicine, Burlington, VT, United States.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'McCluskey', 'Affiliation': 'Department of Psychiatry, Vermont Center on Behavior and Health, University of Vermont Larner College of Medicine, Burlington, VT, United States.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Klemperer', 'Affiliation': 'Department of Psychiatry, Vermont Center on Behavior and Health, University of Vermont Larner College of Medicine, Burlington, VT, United States.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Priest', 'Affiliation': 'Biomedical Statistics Research Core, University of Vermont, Burlington, VT, United States.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Logan', 'Affiliation': 'Hark Inc, Burlington, VT, United States.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Patton', 'Affiliation': 'Hark Inc, Burlington, VT, United States.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Erickson', 'Affiliation': 'Communication, Vermont Department of Health, Burlington, VT, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hicks', 'Affiliation': 'Health Surveillance, Vermont Department of Health, Burlington, VT, United States.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Horton', 'Affiliation': 'Communication, Vermont Department of Health, Burlington, VT, United States.'}, {'ForeName': 'Shayla', 'Initials': 'S', 'LastName': 'Livingston', 'Affiliation': 'Public Health Policy, Vermont Department of Health, Burlington, VT, United States.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Roemhildt', 'Affiliation': 'Health Surveillance, Vermont Department of Health, Burlington, VT, United States.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Singer', 'Affiliation': 'Health Promotion & Disease Prevention, Vermont Department of Health, Burlington, VT, United States.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Trutor', 'Affiliation': 'Alcohol & Drug Abuse Programs, Vermont Department of Health, Burlington, VT, United States.'}, {'ForeName': 'Rhonda', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Health Promotion & Disease Prevention, Vermont Department of Health, Burlington, VT, United States.'}]",Journal of medical Internet research,['10.2196/18446']
1618,32706692,Internet-Based Self-Management Support After High-Altitude Climate Treatment for Severe Asthma: Randomized Controlled Trial.,"BACKGROUND


In patients with severe asthma, high-altitude climate treatment has been shown to improve asthma control. However, asthma symptoms and limitations may increase after finishing inpatient rehabilitation programs and returning to sea level.
OBJECTIVE


We assessed the effectiveness of a patient-tailored, internet-based, self-management strategy in addition to usual care after finishing high-altitude climate treatment.
METHODS


We performed a randomized controlled trial with a 1-year follow-up in patients from a high-altitude asthma center in Davos, Switzerland. At the end of a 12-week multidisciplinary rehabilitation program, 62 adults with asthma were randomized to receive either internet-based self-management support in addition to usual care (n=33) or usual care only after discharge (n=29). The endpoints were changes in asthma-related quality of life according to the Asthma Quality of Life Questionnaire (AQLQ) (a higher score is better) and asthma control according to the Asthma Control Questionnaire (ACQ) (a lower score is better), with a minimally important difference of 0.5 points for both.
RESULTS


Asthma-related quality of life and asthma control declined over time in the usual care strategy group, whereas there was a slower decline in the internet-based strategy group. For both endpoints, mixed-model analysis showed a significant positive effect in favor of internet-based self-management during follow-up (mean AQLQ score difference 0.39, 95% CI 0.092-0.69; P=.01 and ACQ score difference -0.50, 95% CI -0.86 to -0.15; P=.006), which was prominent among patients with uncontrolled asthma at discharge (AQLQ score difference 0.59, 95% CI 0.19-0.99; P=.003 and ACQ score difference -0.73, 95% CI -1.18 to -0.28; P=.002).
CONCLUSIONS


Internet-based self-management support was associated with a smaller decline in quality of life and asthma control as compared with usual care, especially in patients with lower asthma control, after completion of high-altitude climate treatment. Internet-based self-management support in adults with severe asthma seems feasible and effective to maintain quality of life and asthma control.
TRIAL REGISTRATION


The trial is registered in the Netherlands Trial Register (NTR1995).",2020,"Internet-based self-management support in adults with severe asthma seems feasible and effective to maintain quality of life and asthma control.
","['patients from a high-altitude asthma center in Davos, Switzerland', 'Severe Asthma', 'adults with severe asthma', '62 adults with asthma', 'patients with severe asthma']","['internet-based self-management support in addition to usual care (n=33) or usual care only after discharge', 'Internet-Based Self-Management Support', 'Internet-based self-management support']","['quality of life and asthma control', 'Asthma-related quality of life and asthma control', 'changes in asthma-related quality of life according to the Asthma Quality of Life Questionnaire (AQLQ) (a higher score is better) and asthma control according to the Asthma Control Questionnaire (ACQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238617', 'cui_str': 'High altitude'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}]",62.0,0.119011,"Internet-based self-management support in adults with severe asthma seems feasible and effective to maintain quality of life and asthma control.
","[{'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'Beerthuizen', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Lucia H', 'Initials': 'LH', 'LastName': 'Rijssenbeek-Nouwens', 'Affiliation': 'Dutch Asthma Centre Davos, Davos, Switzerland.'}, {'ForeName': 'Sophia M', 'Initials': 'SM', 'LastName': 'van Koppen', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Rishi J', 'Initials': 'RJ', 'LastName': 'Khusial', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Jiska B', 'Initials': 'JB', 'LastName': 'Snoeck-Stroband', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Jacob K', 'Initials': 'JK', 'LastName': 'Sont', 'Affiliation': 'Department of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, Netherlands.'}]",Journal of medical Internet research,['10.2196/13145']
1619,32717350,A sequential multiple assignment randomized trial (SMART) protocol for empirically developing an adaptive preventive intervention for college student drinking reduction.,"College student alcohol use and associated negative consequences are clear public health problems with consequences including damage to self, others, and institutions. This paper describes the protocol of a research study designed to answer a number of important questions in the development of an adaptive preventive intervention (API) to reduce high-risk drinking among first-year college students. The API is designed to educate students and to motivate heavy-drinking college students to engage in existing resources to support reducing high-risk alcohol use, by leveraging technology-based intervention modalities. The primary outcome is a reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization. Adaptive preventive interventions have the potential to reduce the acute and long-term negative health consequences of young adult alcohol use.",2020,"The primary outcome is a reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization.","['college student drinking reduction', 'first-year college students']",['adaptive preventive intervention (API'],"['reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization']","[{'cui': 'C4042862', 'cui_str': 'Alcohol Drinking, College Students'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}]",,0.0187936,"The primary outcome is a reduction in binge drinking, with secondary outcomes of reducing negative alcohol-related consequences and increasing health services utilization.","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN 55415, USA. Electronic address: mpatrick@umn.edu.""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Boatman', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 420 Delaware Street Southeast, MMC 303 Mayo, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Morrell', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN 55415, USA.""}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Wagner', 'Affiliation': ""Institute for Translational Research in Children's Mental Health, University of Minnesota, 1100 Washington Avenue South, Suite 101, Minneapolis, MN 55415, USA.""}, {'ForeName': 'Grace R', 'Initials': 'GR', 'LastName': 'Lyden', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 420 Delaware Street Southeast, MMC 303 Mayo, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Nahum-Shani', 'Affiliation': 'Institute for Social Research, University of Michigan, P.O. Box 1248, 426 Thompson Street, Ann Arbor, MI 48106, USA.'}, {'ForeName': 'Cheryl A', 'Initials': 'CA', 'LastName': 'King', 'Affiliation': 'Department of Psychiatry, University of Michigan, 4250 Plymouth Road, Room 2129, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'Department of Psychiatry, University of Michigan, 4250 Plymouth Road, Room 2129, Ann Arbor, MI 48109, USA; Injury Prevention Center, University of Michigan, 2800 Plymouth Road, NCRC Building 10, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for the Study of Health and Risk Behaviors, University of Washington, 1100 Northeast 45(th) Street, Suite 300, Seattle, WA 98105, USA.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Larimer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Center for the Study of Health and Risk Behaviors, University of Washington, 1100 Northeast 45(th) Street, Suite 300, Seattle, WA 98105, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Vock', 'Affiliation': 'Division of Biostatistics, University of Minnesota, 420 Delaware Street Southeast, MMC 303 Mayo, Minneapolis, MN 55455, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Almirall', 'Affiliation': 'Institute for Social Research, University of Michigan, P.O. Box 1248, 426 Thompson Street, Ann Arbor, MI 48106, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106089']
1620,32717448,"Analgesic efficacy of ultrasound guided bilateral transversus thoracis muscle plane block in pediatric cardiac surgery: a randomized, double-blind, controlled study.","STUDY OBJECTIVE


Adequate perioperative pain control in children undergoing cardiac surgery is mandatory. Intravenous opioids and neuraxial anesthetic techniques have been used but didn't gained any popularity. The aim of the current study was to evaluate the analgesic efficacy of transversus thoracis plane (TTP) block in pediatric cardiac surgery.
DESIGN


Superiority, randomized, double-blind, controlled study.
SETTING


Intraoperative and postoperative in intensive care unit (ICU), Mansoura university children hospital, Egypt.
PATIENTS


Eighty pediatric patients aged 2-12 years, undergoing cardiac surgery via median sternotomy, were randomly allocated into 2 equal groups, the control group and TTP block group.
INTERVENTIONS


Controlled group received only fentanyl for perioperative analgesia, while TTP block was performed in the intervention group (TTP group).
MEASUREMENTS


The primary outcome measure was the total dose of fentanyl in the first postoperative 24 h after extubation, while the secondary outcome measures were postoperative pain score, intraoperative fentanyl consumption, time to extubation and ICU length of stay.
MAIN RESULTS


During the first postoperative 24 h, total fentanyl consumption was significantly lower (P < 0.05) in the TTP block group (9.892 ± 3.397 μg/kg) than the control group (18.500 ± 3.401 μg/kg) and modified objective pain score was significantly (P < 0.05) lower in TTP block group than the control group all over the time. Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
CONCLUSION


The use of TTP block decreased perioperative fentanyl consumption and reduced postoperative pain intensity.",2020,"Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
","['children undergoing cardiac surgery', 'Intraoperative and postoperative in intensive care unit (ICU), Mansoura university children hospital, Egypt', 'Eighty pediatric patients aged 2-12\xa0years, undergoing cardiac surgery via median sternotomy', 'pediatric cardiac surgery']","['TTP block', 'transversus thoracis plane (TTP) block', 'fentanyl for perioperative analgesia, while TTP block was performed in the intervention group (TTP group', 'control group and TTP block group', 'ultrasound guided bilateral transversus thoracis muscle plane block']","['postoperative pain intensity', 'modified objective pain score', 'perioperative fentanyl consumption', 'Analgesic efficacy', 'analgesic efficacy', 'total fentanyl consumption', 'Total intraoperative fentanyl requirement', 'postoperative pain score, intraoperative fentanyl consumption, time to extubation and ICU length of stay', 'total dose of fentanyl in the first postoperative 24\xa0h after extubation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}]","[{'cui': 'C1744608', 'cui_str': 'Structure of transverse thoracis muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C1096288', 'cui_str': 'Perioperative analgesia'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",80.0,0.408484,"Total intraoperative fentanyl requirement was significantly (P < 0.05) lower in TTP block group (8.27 ± 1.170 μg/kg) than the control group (13.72 ± 1.186 μg/kg).
","[{'ForeName': 'Ibrahim I', 'Initials': 'II', 'LastName': 'Abdelbaser', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, 2 El-Gomhouria St, Mansoura 35516, Egypt. Electronic address: ibraheem2005@mans.edu.eg.'}, {'ForeName': 'Nabil A', 'Initials': 'NA', 'LastName': 'Mageed', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Mansoura University, 2 El-Gomhouria St, Mansoura 35516, Egypt.'}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.110002']
1621,32717684,"Switching to fingolimod in PREFERMS: Effect of treatment history and naïvety on clinical, MRI and treatment satisfaction outcomes ✰ .","BACKGROUND


Injectable disease-modifying therapies (iDMTs) are often used as first-line treatments for relapsing multiple sclerosis. Fingolimod is frequently used following treatment with iDMTs. Whether prior iDMT treatment impacts the effectiveness of subsequent fingolimod therapy is unclear. Here, we assessed switching from iDMTs to fingolimod, and the impact of treatment history on fingolimod escalation using data from the 12-month 'Prospective, Randomized, active-controlled, open-label study to Evaluate patient retention on Fingolimod versus approved first-line disease-modifying thErapies in adults with Relapsing-remitting Multiple Sclerosis' (PREFERMS). The study design and results at the end of randomized treatment (EoRT) in PREFERMS have been published.
METHODS


Both treatment-naïve patients and those who had previously received an iDMT were eligible for enrolment in PREFERMS, and one treatment switch was permitted on study. Pre-specified exploratory analyses compared outcomes in those randomized to fingolimod or to an iDMT at end of study (EoS), which included time spent on randomized and on switch treatment. Post hoc exploratory analyses (unadjusted for multiplicity owing to the large number of comparisons) among patients randomized to an iDMT who switched to fingolimod, compared outcomes longitudinally before (EoRT) and after (EoS) switching, and compared outcomes at EoRT and EoS among subgroups stratified by iDMT-treatment history. Outcomes included brain volume, various measures of gadolinium-enhancing [Gd+] lesion counts, annualized relapse rate (ARR), Symbol Digit Modalities Test (SDMT) score, patient-reported treatment satisfaction using the Medication Satisfaction Questionnaire (MSQ) and adverse event (AE) rates.
RESULTS


At EoS, 255 of 439 patients randomized to an iDMT had switched to fingolimod and 27 of 436 patients randomized to fingolimod had switched to an iDMT. By EoS, 44.2% of total treatment exposure in the iDMT group was to fingolimod and the mean time spent on fingolimod in this group was 220 days (approximately 7 months). Outcomes in the fingolimod group at EoS (brain volume, changes in Gd+ lesion counts, ARR, oral SDMT score and MSQ score) were similar to those seen at EoRT, but in the iDMT group these outcomes were more favorable at EoS than at EoRT and were similar to rates seen in the fingolimod group. Among patients who switched from iDMT to fingolimod, there were longitudinal improvements in ARR (EoRT, 0.3 [95% confidence interval (CI), 0.2-0.4]; EoS, 0.2 [0.1-0.3]; odds ratio, 0.5 [0.3-0.9]) and in treatment satisfaction (proportion of patients with MSQ > 5; EoRT, 67.4%; EoS, 90.4%; odds ratio, 5.7 [95% CI, 3.4-9.4]) after fingolimod treatment, and changes in brain volume, Gd+ lesion count, and AEs or AEs causing discontinuation were also more favorable at EoS than at EoRT. In all patient groups stratified by iDMT-treatment history, differences in outcomes narrowed or disappeared after fingolimod treatment.
CONCLUSION


These analyses indicate that patients in PREFERMS had improved outcomes within months of switching to fingolimod from an iDMT and that improvements occurred irrespective of the number of iDMTs previously administered. These data provide a unique opportunity to explore clinical, radiological and safety outcomes associated with a range of clinically relevant treatment pathways.",2020,"In all patient groups stratified by iDMT-treatment history, differences in outcomes narrowed or disappeared after fingolimod treatment.
","['At EoS, 255 of 439 patients randomized to an iDMT had switched to fingolimod and 27 of 436 patients randomized to', 'Both treatment-naïve patients and those who had previously received an iDMT were eligible for enrolment in PREFERMS, and one treatment switch was permitted on study', ""adults with Relapsing-remitting Multiple Sclerosis' (PREFERMS""]","['fingolimod had switched to an iDMT', 'Fingolimod versus approved first-line disease-modifying thErapies']","['EoS (brain volume, changes in Gd+ lesion counts, ARR, oral SDMT score and MSQ score', 'mean time spent on fingolimod', 'brain volume, various measures of gadolinium-enhancing [Gd+] lesion counts, annualized relapse rate (ARR), Symbol Digit Modalities Test (SDMT) score, patient-reported treatment satisfaction using the Medication Satisfaction Questionnaire (MSQ) and adverse event (AE) rates', 'longitudinal improvements in ARR', 'brain volume, Gd+ lesion count, and AEs or AEs causing discontinuation']","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}]","[{'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1699926', 'cui_str': 'fingolimod'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0451522', 'cui_str': 'Symbol digit modalities test'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",439.0,0.0609136,"In all patient groups stratified by iDMT-treatment history, differences in outcomes narrowed or disappeared after fingolimod treatment.
","[{'ForeName': 'Samuel F', 'Initials': 'SF', 'LastName': 'Hunter', 'Affiliation': 'Advanced Neurosciences Institute, 101 Forrest Crossing Blvd. Suite 103, Franklin, TN 37064, United States. Electronic address: sfhunter@neurosci.us.'}, {'ForeName': 'Florian P', 'Initials': 'FP', 'LastName': 'Thomas', 'Affiliation': 'Hackensack Meridian School of Medicine at Seton Hall University, South Orange, and Hackensack University Medical Center, Hackensack, NJ, United States. Electronic address: florian.thomas@hackensackmeridian.org.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cascione', 'Affiliation': 'Tampa Neurology Associates, Tampa, FL, United States. Electronic address: me@markcascione.com.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Williams', 'Affiliation': 'Oxford PharmaGenesis, Oxford, United Kingdom. Electronic address: ian.williams@pharmagenesis.com.'}, {'ForeName': 'Xiangyi', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: xiangyi.meng@novartis.com.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Schofield', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: lesley.schofield@novartis.com.'}, {'ForeName': 'Jamie L', 'Initials': 'JL', 'LastName': 'Weiss', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: jamie.weiss@novartis.com.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Tenenbaum', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States. Electronic address: nadia.tenebaum@novartis.com.'}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'UCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, United States. Electronic address: bruce.cree@ucsf.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102346']
1622,32680894,Oncology to specialised palliative home care systematic transition: the Domus randomised trial.,"OBJECTIVES


To assess the effect of a systematic, fast-track transition from oncological treatment to specialised palliative care at home on symptom burden, to explore intervention mechanisms through patient and intervention provider characteristics and to assess long-term survival and place of death.
MEASURES


The effect of a systematic, fast-track transition from oncological treatment to specialised palliative care at home on patient symptom burden was studied in the Domus randomised clinical trial. Participants had incurable cancer and limited treatment options. The intervention was provided by specialised palliative home teams (SPT) based in hospice or hospital and was enriched with a psychological intervention for patient and caregiver dyad. Symptom burden was measured with Edmonton Symptom Assessment System (ESAS-r) at baseline, 8 weeks and 6 months follow-up and analysed with mixed models. Survival and place of death was analysed with Kaplan-Meier and Fisher's exact tests.
RESULTS


The study included 322 patients. Tiredness was significantly improved for the Domus intervention group at 6 months while the other nine symptom outcomes were not significantly different from the control group. Exploring the efficacy of intervention provider demonstrated significant differences in favour of the hospice SPT on four symptoms and total symptom score. Patients with children responded more favourably to the intervention. The long-term follow-up demonstrated no differences between the intervention and the control groups regarding survival or home deaths.
CONCLUSIONS


The Domus intervention may reduce tiredness. Moreover, the intervention provider and having children might play a role concerning intervention efficacy. The intervention did not affect survival or home deaths.
TRIAL REGISTRATION NUMBER


NCT01885637.",2020,Exploring the efficacy of intervention provider demonstrated significant differences in favour of the hospice SPT on four symptoms and total symptom score.,"['Participants had incurable cancer and limited treatment options', 'Patients with children', '322 patients']",['specialised palliative home teams (SPT) based in hospice or hospital and was enriched with a psychological intervention'],"['Tiredness', 'survival or home deaths', 'tiredness', 'Survival and place of death']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517712', 'cui_str': '322'}]","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019947', 'cui_str': 'Hospice'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0421611', 'cui_str': 'Place of death'}]",322.0,0.131257,Exploring the efficacy of intervention provider demonstrated significant differences in favour of the hospice SPT on four symptoms and total symptom score.,"[{'ForeName': 'Kirstine', 'Initials': 'K', 'LastName': 'Benthien', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark kirstine.skov.benthien@regionh.dk.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Diasso', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'von Heymann', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mie', 'Initials': 'M', 'LastName': 'Nordly', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Geana', 'Initials': 'G', 'LastName': 'Kurita', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Helle', 'Initials': 'H', 'LastName': 'Timm', 'Affiliation': 'REHPA, The Danish Knowledge Center for Rehabilitation and Palliative Care, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Christoffer', 'Initials': 'C', 'LastName': 'Johansen', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Kjellberg', 'Affiliation': 'VIVE Health, VIVE-The Danish Center for Social Science Research, Copenhagen, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'von der Maase', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Sjøgren', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}]",BMJ supportive & palliative care,['10.1136/bmjspcare-2020-002325']
1623,32682429,A multimodal intervention to improve hand hygiene compliance in peripheral wards of a tertiary care university centre: a cluster randomised controlled trial.,"BACKGROUND


Interventions to improve hand hygiene (HH) compliance are a key element in the practice infection prevention and control. It was our objective to assess the effect of a multimodal intervention on HH compliance at a tertiary care university hospital. As a secondary objective, we investigated the effect of the intervention on the occurrence of device-associated bloodstream infections.
METHODS


We performed a single centre cluster randomised controlled trial at a university hospital in Germany. Twenty peripheral wards were invited to participate and randomly assigned to either the intervention (n = 10) or control group (n = 10). Quarterly, specifically trained student employees conducted direct compliance observations in all twenty wards. The intervention entailed dissemination of teaching materials on aseptic procedures, equipment with flexibly mountable alcoholic hand rub dispensers, and quarterly feedback on HH compliance.
RESULTS


In total, 21,424 HH opportunities were observed. Overall, compliance did not change significantly in either group (intervention group: 59% vs. 61% (1482 HH actions for 2494 HH opportunities vs. 5033 HH actions for 8215 HH opportunities), odds ratio (OR) 1.08 (95% confidence interval (CI95) 0.88, 1.33)); control group: 59% vs. 60% (1457 HH actions for 2484 HH opportunities vs. 4948 HH actions for 8231 HH opportunities), OR 1.06 (CI95 0.84, 1.35)). Compliance prior to aseptic procedures improved significantly in the intervention group from 44% (168 HH actions for 380 HH opportunities) to 53% (764 HH actions for 1452 HH opportunities) (OR 1.40 (CI95 1.04, 1.89), p = 0.03), while no significant increase was noted in the control group. In the intervention group, significantly fewer device-associated bloodstream infections per 1000 patient-days occurred than in the control group (84 vs. 123, incidence rate ratio 0.61 (CI95 0.46, 0.81), p < 0.01).
CONCLUSIONS


The lack of a significant overall improvement of HH compliance demonstrated that comprehensive implementation of HH interventions in multiple wards simultaneously is difficult. However, through targeted intervention measures, we were able to significantly increase HH compliance before aseptic procedures.",2020,"In the intervention group, significantly fewer device-associated bloodstream infections per 1000 patient-days occurred than in the control group (84 vs. 123, incidence rate ratio 0.61 (CI95 0.46, 0.81), p < 0.01).
","['peripheral wards of a tertiary care university centre', 'Twenty peripheral wards', 'university hospital in Germany', 'HH compliance at a tertiary care university hospital']",['multimodal intervention'],"['Compliance prior to aseptic procedures', 'HH compliance', 'device-associated bloodstream infections']","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0232920', 'cui_str': 'Sterile'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C3494474', 'cui_str': 'Hand Hygiene'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}]",21424.0,0.0706666,"In the intervention group, significantly fewer device-associated bloodstream infections per 1000 patient-days occurred than in the control group (84 vs. 123, incidence rate ratio 0.61 (CI95 0.46, 0.81), p < 0.01).
","[{'ForeName': 'Seven Johannes Sam', 'Initials': 'SJS', 'LastName': 'Aghdassi', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Hygiene and Environmental Medicine, Berlin, Germany. seven-johannes-sam.aghdassi@charite.de.'}, {'ForeName': 'Christin', 'Initials': 'C', 'LastName': 'Schröder', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Hygiene and Environmental Medicine, Berlin, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Lemke', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Hygiene and Environmental Medicine, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Behnke', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Hygiene and Environmental Medicine, Berlin, Germany.'}, {'ForeName': 'Patricia Manuela', 'Initials': 'PM', 'LastName': 'Fliss', 'Affiliation': 'BODE SCIENCE CENTER, BODE Chemie GmbH, Hamburg, Germany.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Plotzki', 'Affiliation': 'BODE SCIENCE CENTER, BODE Chemie GmbH, Hamburg, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Wenk', 'Affiliation': 'BODE SCIENCE CENTER, BODE Chemie GmbH, Hamburg, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Gastmeier', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Hygiene and Environmental Medicine, Berlin, Germany.'}, {'ForeName': 'Tobias Siegfried', 'Initials': 'TS', 'LastName': 'Kramer', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Hygiene and Environmental Medicine, Berlin, Germany.'}]",Antimicrobial resistance and infection control,['10.1186/s13756-020-00776-9']
1624,32682793,New Ultrasonic Tip Decreases Uninstrumented Surface and Debris in Flattened Canals: A Micro-computed Tomographic Study.,"INTRODUCTION


The preparation of flattened root canals using reciprocating or rotary nickel-titanium instruments associated with the Flatsonic ultrasonic tip (Helse Ultrasonic, Santa Rosa de Viterbo, SP, Brazil) was evaluated by micro-computed tomographic imaging.
METHODS


Twenty-four flattened distal canals of mandibular molars with a buccolingual diameter 4 or more times larger than the mesiodistal diameter were selected. The root canals were randomly divided into 2 experimental groups for preparation: a Reciproc Blue (RB; VDW GmbH, Munich, Germany) 40/.06 file in reciprocating motion or ProDesign Logic (PDL; Easy Equipamentos Odontológicos, Belo Horizonte, MG, Brazil) 40/.01 and 40/.05 files in rotary motion (n = 12). A complementary preparation was performed with the Flatsonic ultrasonic tip for both preparations. Micro-computed tomographic scanning at a resolution of 8.74 μm was performed before and after preparation with the nickel-titanium instruments and after the use of the Flatsonic tip. The percentages of increase in volume, debris, and uninstrumented surface were analyzed. The data obtained were submitted to the paired and unpaired t test, analysis of variance, and the Tukey test (α = 5%).
RESULTS


The percentage increase in volume, debris, and uninstrumented surface was similar between RB and PDL in the entire root canal (P > .05). The PDL promoted a lower percentage of debris in the cervical third and a lower percentage of increase in volume in the apical third in comparison with RB (P < .05). The Flatsonic decreased debris and uninstrumented surface after PDL preparation in all thirds (P < .05). After preparation with RB, the Flatsonic decreases the debris in the cervical third and the uninstrumented surface in the cervical and middle thirds (P < .05).
CONCLUSIONS


The preparation of flattened root canals using RB or PDL produced a high percentage of debris and uninstrumented surface. The Flatsonic ultrasonic tip significantly improved the cleaning of flattened root canals.",2020,Flatsonic decreased debris and uninstrumented surface after PDL preparation in all thirds (P < .05).,['Twenty-four flattened distal canals of mandibular molars with a buccolingual diameter 4 or more times larger than the mesiodistal diameter were selected'],"['preparation: Reciproc Blue (RB', 'PDL', 'Micro-CT scanning', 'New ultrasonic tip', 'flattened root canals using reciprocating or rotary nickel-titanium (NiTi']","['Flatsonic decreased debris and uninstrumented surface', 'volume, debris and uninstrumented surface', 'Flatsonic ultrasonic tip']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0023963', 'cui_str': 'Logic'}, {'cui': 'C2350281', 'cui_str': 'MicroCT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0068790', 'cui_str': 'nitinol'}]","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}]",24.0,0.014489,Flatsonic decreased debris and uninstrumented surface after PDL preparation in all thirds (P < .05).,"[{'ForeName': 'Airton Oliveira', 'Initials': 'AO', 'LastName': 'Santos-Junior', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, São Paulo State University, Araraquara, São Paulo, Brazil.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Tanomaru-Filho', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, São Paulo State University, Araraquara, São Paulo, Brazil. Electronic address: tanomaru@uol.com.br.'}, {'ForeName': 'Jader Camilo', 'Initials': 'JC', 'LastName': 'Pinto', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, São Paulo State University, Araraquara, São Paulo, Brazil.'}, {'ForeName': 'Karina Ines Medina Carita', 'Initials': 'KIMC', 'LastName': 'Tavares', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, São Paulo State University, Araraquara, São Paulo, Brazil.'}, {'ForeName': 'Mariana Mena Barreto', 'Initials': 'MMB', 'LastName': 'Pivoto-João', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, São Paulo State University, Araraquara, São Paulo, Brazil.'}, {'ForeName': 'Juliane Maria', 'Initials': 'JM', 'LastName': 'Guerreiro-Tanomaru', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, São Paulo State University, Araraquara, São Paulo, Brazil.'}]",Journal of endodontics,['10.1016/j.joen.2020.07.012']
1625,32317371,Comparison of intra-aneurysmal flow modification using optical flow imaging to evaluate the performance of Evolve and Pipeline flow diverting stents.,"BACKGROUND


Flow diverting stent (FDS) devices have revolutionized the treatment of large and complex brain aneurysms, but there is still room for improvement, particularly on the flow diversion properties and technical challenges associated with stent deployment. In this study we compared flow diversion properties between the new generation Surpass Evolve (Stryker) and the Pipeline Flex (Medtronic) devices by quantitatively evaluating intra-aneurysmal flow modification.
METHODS


An in vitro experimental set-up was used, consisting of four patient-specific silicone models with internal carotid aneurysms and a circulating hemodynamic simulation system with pulsatile flow. The Evolve and Pipeline stents were deployed across the neck of each aneurysm model, in a randomized fashion, for a total of eight device deployments. A 60 frames/s digital subtraction angiography run was acquired before and after placement of each FDS. An optical flow-analysis method was used to measure intra-aneurysmal flow modification induced by the stent by calculating a mean aneurysm flow amplitude (MAFA) before and after stent placement and computing a ratio.
RESULTS


Average MAFA ratio values calculated from pre- and post-stent placement were significantly lower after deployment of the Evolve (n=4, mean=0.62±0.09) compared with the Pipeline device (n=4, mean=0.71±0.06) (p=0.03).
CONCLUSIONS


Our in vitro results show that the Evolve stent had a superior flow diversion effect compared with the Pipeline stent, which-based on clinical evidence-suggest it may promote faster aneurysm occlusion rates in patients.",2020,"RESULTS


Average MAFA ratio values calculated from pre- and post-stent placement were significantly lower after deployment of the Evolve (n=4, mean=0.62±0.09) compared with the Pipeline device (n=4, mean=0.71±0.06) (p=0.03).
",[],"['Flow diverting stent (FDS) devices', 'Evolve and Pipeline flow diverting stents']","['aneurysm occlusion rates', 'superior flow diversion effect', 'Average MAFA ratio values']",[],"[{'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332253', 'cui_str': 'Evolving'}]","[{'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0185033', 'cui_str': 'Diversion procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1532109', 'cui_str': 'Ratio value'}]",,0.0326068,"RESULTS


Average MAFA ratio values calculated from pre- and post-stent placement were significantly lower after deployment of the Evolve (n=4, mean=0.62±0.09) compared with the Pipeline device (n=4, mean=0.71±0.06) (p=0.03).
","[{'ForeName': 'Nicole Mariantonia', 'Initials': 'NM', 'LastName': 'Cancelliere', 'Affiliation': 'Division of Neuroradiology, Department of Medical Imaging, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Nicholson', 'Affiliation': 'Division of Neuroradiology, Department of Medical Imaging, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Radovanovic', 'Affiliation': 'Division of Neurosurgery, Department of Surgery, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Karla Mirella', 'Initials': 'KM', 'LastName': 'Mendes', 'Affiliation': 'Division of Neuroradiology, Department of Medical Imaging, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Orru', 'Affiliation': 'Division of Neuroradiology, Department of Medical Imaging, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Krings', 'Affiliation': 'Division of Neuroradiology, Department of Medical Imaging, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Vitor M', 'Initials': 'VM', 'LastName': 'Pereira', 'Affiliation': 'Division of Neuroradiology, Department of Medical Imaging, Toronto Western Hospital, University Health Network, Toronto, Ontario, Canada vitor.pereira@uhn.ca.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2019-015696']
1626,32697957,"Effects of long-term concurrent training to failure or not in muscle power output, muscle quality and cardiometabolic risk factors in older men: A secondary analysis of a randomized clinical trial.","This study investigated the effects of concurrent training performed either with repetitions to failure or not to failure in muscle power, muscle quality (MQ), peak oxygen uptake (VO 2peak ), and visceral fat in older men. This is an ancillary analysis of a randomized controlled trial. 36 older men (mean age ± SD; 67.1 ± 5.1 years) were randomized into three groups: one performing repetitions to failure (RFG, n = 13), another performing repetitions not to failure and 50% of the repetitions of the RFG (NFG, n = 12), and third performing repetitions not to failure with equal training volume of the RFG (ENFG, n = 11). The training was performed twice a week for 20 weeks at intensities ranging from 65 to 80% of maximal strength. In each session, the individuals started with strengthening exercises and then performed aerobic exercise (i.e., walking) on a treadmill. The primary endpoint was change from baseline to post-20 wk of absolute and relative muscle power output during squat and countermovement jump, ultrasound measurements for MQ using quadriceps echo intensity, and visceral fat thickness, as well as their VO 2peak  through a maximal incremental test on a treadmill. All training groups improved similarly and significantly jump height (ranging from 9 to 16%) and all their muscle power outcomes (mean change ranging from 2 to 7%) (P < .001). In addition, all groups significantly decreased visceral fat thickness (ranging from -11 to -21%) (P < .001), and significantly increased VO 2peak  (ranging from 4 to 8%) (P < .01), with no differences between groups. No changes were observed in the MQ outcomes. Concurrent training performed using repetitions to failure or not to failure promoted similar gains in the muscle power output, aerobic capacity, and visceral fat in healthy older men.",2020,All training groups improved similarly and significantly jump height (ranging from 9 to 16%) and all their muscle power outcomes (mean change ranging from 2 to 7%) (P < .001).,"['36 older men (mean age\u202f±\u202fSD; 67.1\u202f±\u202f5.1\u202fyears', 'healthy older men', 'older men']","['another performing repetitions not to failure and 50% of the repetitions of the RFG (NFG, n\u202f=\u202f12), and third performing repetitions not to failure with equal training volume of the RFG (ENFG, n', 'strengthening exercises and then performed aerobic exercise (i.e., walking) on a treadmill']","['VO 2peak', 'visceral fat thickness', 'MQ outcomes', 'muscle power output, muscle quality and cardiometabolic risk factors', 'change from baseline to post-20\u202fwk of absolute and relative muscle power output during squat and countermovement jump, ultrasound measurements for MQ using quadriceps echo intensity, and visceral fat thickness, as well as their VO 2peak  through a maximal incremental test on a treadmill', 'jump height', 'muscle power, muscle quality (MQ), peak oxygen uptake (VO 2peak ), and visceral fat']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",36.0,0.0273081,All training groups improved similarly and significantly jump height (ranging from 9 to 16%) and all their muscle power outcomes (mean change ranging from 2 to 7%) (P < .001).,"[{'ForeName': 'Juliana L', 'Initials': 'JL', 'LastName': 'Teodoro', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Larissa X N', 'Initials': 'LXN', 'LastName': 'da Silva', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Bruno M', 'Initials': 'BM', 'LastName': 'Baroni', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Grazioli', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Carolina G', 'Initials': 'CG', 'LastName': 'Fritsch', 'Affiliation': 'Graduate Program in Rehabilitation Sciences, Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Régis', 'Initials': 'R', 'LastName': 'Radaelli', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Saez de Asteasu', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil; Navarrabiomed, Complejo Hospitalario de Navarra (CHN)-Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Martim', 'Initials': 'M', 'LastName': 'Bottaro', 'Affiliation': 'College of Physical Education, University of Brasilia, Brasília, DF, Brazil.'}, {'ForeName': 'Juliano', 'Initials': 'J', 'LastName': 'Farinha', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Ronei S', 'Initials': 'RS', 'LastName': 'Pinto', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.'}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Cadore', 'Affiliation': 'School of Physical Education, Physiotherapy and Dance, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil. Electronic address: edu.cadore@ufrgs.br.'}]",Experimental gerontology,['10.1016/j.exger.2020.111023']
1627,32710219,Correction to: Osseous ingrowth in allogeneic bone blocks applied for vertical bone augmentation: a preclinical randomized controlled study.,"In the article by Möst et al., entitled ""Osseous ingrowth in allogeneic bone blocks applied for vertical bone augmentation: a preclinical randomized controlled study.",2020,"In the article by Möst et al., entitled ""Osseous ingrowth in allogeneic bone blocks applied for vertical bone augmentation: a preclinical randomized controlled study.",['vertical bone augmentation'],[],[],"[{'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]",[],[],,0.0260633,"In the article by Möst et al., entitled ""Osseous ingrowth in allogeneic bone blocks applied for vertical bone augmentation: a preclinical randomized controlled study.","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Moest', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany. tobias.moest@uk-erlangen.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Frabschka', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Marco Rainer', 'Initials': 'MR', 'LastName': 'Kesting', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Christian Martin', 'Initials': 'CM', 'LastName': 'Schmitt', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Gesche', 'Initials': 'G', 'LastName': 'Frohwitter', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Lutz', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}, {'ForeName': 'Karl Andreas', 'Initials': 'KA', 'LastName': 'Schlegel', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University of Erlangen-Nürnberg, Glueckstraße 11, 91054, Erlangen, Germany.'}]",Clinical oral investigations,['10.1007/s00784-020-03466-3']
1628,32706708,Evaluation of a Web-Based Self-Management Program for Patients With Cardiovascular Disease: Explorative Randomized Controlled Trial.,"BACKGROUND


Web-based self-management programs have the potential to support patients with cardiovascular disease (CVD) in their self-management (eg, by focusing on behavior change and improving physical activity). The intervention mapping framework was used to develop a web-based program called Vascular View. The Vascular View program contained 6 modules (coping with CVD, setting boundaries, lifestyle, healthy nutrition, being physically active, interaction with health professionals) aiming to increase self-management behavior by tailoring to the perceived problems and (support) needs of patients after CVD.
OBJECTIVE


The aim was to test the effectiveness of Vascular View before embarking on a full-scale randomized clinical trial (RCT) by evaluating the potential effectiveness and effect sizes of the Vascular View program and identifying outcome measures most likely to capture the potential benefits.
METHODS


An explorative RCT was performed. Both control and intervention groups received care as usual and, in addition, the intervention group received 12 months of access to a web-based self-management program. Assessment occurred at baseline, 6 months, and 12 months. Outcome measures included general patient-reported outcome measurements: Illness Perception Questionnaire (IPQ), Rand-36, Patient Activation Measure, and patient self-efficacy. Module-specific patient-reported outcome measurements were Beliefs about Medicines Questionnaire, International Physical Activity Questionnaire, Dutch Healthy Diet Index, Fagerström Test for Nicotine Dependence (FTND), Alcohol Use Disorders Identification Test, and Perceived Efficacy in Patient-Physician Interaction. Linear mixed models for repeated measures using intention-to-treat and per-protocol analysis were applied to study differences between the patients in the intervention and control groups. Floor and ceiling effects were explored to give insight into the outcome measures most likely to capture the potential benefits.
RESULTS


A total of 105 patients in the control group and 103 patients in the intervention group participated in the study. A positive direction of change between baseline and 12 months was shown for most outcome measurements in favor of the intervention group, of which 2 out of 10 outcomes showed a significant effect: attribution of cause of the disease to risk factors and immunity factors (IPQ) and dependency of nicotine (FTND). Floor and ceiling effects were seen in the IPQ, Rand-36, and the self-efficacy questionnaire.
CONCLUSIONS


No conclusion for the efficacy of the Vascular View program or selection of outcome measurements can be taken yet. A process evaluation will be conducted to gain thorough insight into the working elements of the program, patient needs in eHealth, and the use of the program by patients. This can determine for whom web-based self-management programs will work and help to adapt the program.
TRIAL REGISTRATION


Dutch Trial Register NTR5412; https://www.trialregister.nl/trial/5303.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/resprot.6352.",2020,"A positive direction of change between baseline and 12 months was shown for most outcome measurements in favor of the intervention group, of which 2 out of 10 outcomes showed a significant effect: attribution of cause of the disease to risk factors and immunity factors (IPQ) and dependency of nicotine (FTND).","['Patients With Cardiovascular Disease', '105 patients in the control group and 103 patients in the intervention group participated in the study', 'patients with cardiovascular disease (CVD']","['Web-Based Self-Management Program', 'care as usual and, in addition, the intervention group received 12 months of access to a web-based self-management program', 'NTR5412']","['self-efficacy questionnaire', 'Beliefs about Medicines Questionnaire, International Physical Activity Questionnaire, Dutch Healthy Diet Index, Fagerström Test for Nicotine Dependence (FTND), Alcohol Use Disorders Identification Test, and Perceived Efficacy in Patient-Physician Interaction', 'significant effect: attribution of cause of the disease to risk factors and immunity factors (IPQ) and dependency of nicotine (FTND', 'general patient-reported outcome measurements: Illness Perception Questionnaire (IPQ), Rand-36, Patient Activation Measure, and patient self-efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0028043', 'cui_str': 'Nicotine dependence'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031830', 'cui_str': 'Physician Patient Relations'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C4075707', 'cui_str': 'Patient Activation Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",105.0,0.0846981,"A positive direction of change between baseline and 12 months was shown for most outcome measurements in favor of the intervention group, of which 2 out of 10 outcomes showed a significant effect: attribution of cause of the disease to risk factors and immunity factors (IPQ) and dependency of nicotine (FTND).","[{'ForeName': 'Marscha M', 'Initials': 'MM', 'LastName': 'Engelen', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'van Dulmen', 'Affiliation': 'Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Puijk-Hekman', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Hester', 'Initials': 'H', 'LastName': 'Vermeulen', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Maria Wg', 'Initials': 'MW', 'LastName': 'Nijhuis-van der Sanden', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Sebastian Jh', 'Initials': 'SJ', 'LastName': 'Bredie', 'Affiliation': 'Department of Internal Medicine, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Betsie Gi', 'Initials': 'BG', 'LastName': 'van Gaal', 'Affiliation': 'IQ Healthcare, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}]",Journal of medical Internet research,['10.2196/17422']
1629,32706716,Efficacy of a Smartphone App Intervention for Reducing Caregiver Stress: Randomized Controlled Trial.,"BACKGROUND


Caregivers play a pivotal role in maintaining an economically viable health care system, yet they are characterized by low levels of psychological well-being and consistently report unmet needs for psychological support. Mobile app-based (mobile health [mHealth]) interventions present a novel approach to both reducing stress and improving well-being.
OBJECTIVE


This study aims to evaluate the effectiveness of a self-guided mobile app-based psychological intervention for people providing care to family or friends with a physical or mental disability.
METHODS


In a randomized, single-blind, controlled trial, 183 caregivers recruited through the web were randomly allocated to either an intervention (n=73) or active control (n=110) condition. The intervention app contained treatment modules combining daily self-monitoring with third-wave (mindfulness-based) cognitive-behavioral therapies, whereas the active control app contained only self-monitoring features. Both programs were completed over a 5-week period. It was hypothesized that intervention app exposure would be associated with decreases in depression, anxiety, and stress, and increases in well-being, self-esteem, optimism, primary and secondary control, and social support. Outcomes were assessed at baseline, postintervention, and 3-4 months postintervention. App quality was also assessed.
RESULTS


In total, 25% (18/73) of the intervention participants were lost to follow-up at 3 months, and 30.9% (34/110) of the participants from the wait-list control group dropped out before the postintervention survey. The intervention group experienced reductions in stress (b=-2.07; P=.04) and depressive symptoms (b=-1.36; P=.05) from baseline to postintervention. These changes were further enhanced from postintervention to follow-up, with the intervention group continuing to report lower levels of depression (b=-1.82; P=.03) and higher levels of emotional well-being (b=6.13; P<.001), optimism (b=0.78; P=.007), self-esteem (b=-0.84; P=.005), support from family (b=2.15; P=.001), support from significant others (b=2.66; P<.001), and subjective well-being (b=4.82; P<.001). On average, participants completed 2.5 (SD 1.05) out of 5 treatment modules. The overall quality of the app was also rated highly, with a mean score of 3.94 out of a maximum score of 5 (SD 0.58).
CONCLUSIONS


This study demonstrates that mHealth psychological interventions are an effective treatment option for caregivers experiencing high levels of stress. Recommendations for improving mHealth interventions for caregivers include offering flexibility and customization in the treatment design.
TRIAL REGISTRATION


Australian New Zealand Clinical Trial Registry ACTRN12616000996460; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371170.",2020,The intervention group experienced reductions in stress (b=-2.07; P=.04) and depressive symptoms (b=-1.36; P=.05) from baseline to postintervention.,"['183 caregivers recruited through the web were randomly allocated to either an intervention (n=73) or active control (n=110) condition', 'people providing care to family or friends with a physical or mental disability', 'caregivers experiencing high levels of stress']","['self-guided mobile app-based psychological intervention', 'mHealth psychological interventions', 'Smartphone App Intervention', 'Mobile app-based (mobile health [mHealth]) interventions', 'intervention app contained treatment modules combining daily self-monitoring with third-wave (mindfulness-based) cognitive-behavioral therapies, whereas the active control app contained only self-monitoring features']","['levels of depression', 'overall quality', 'depression, anxiety, and stress, and increases in well-being, self-esteem, optimism, primary and secondary control, and social support', 'self-esteem', 'reductions in stress', 'depressive symptoms']","[{'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1306341', 'cui_str': 'Mental handicap'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",183.0,0.198433,The intervention group experienced reductions in stress (b=-2.07; P=.04) and depressive symptoms (b=-1.36; P=.05) from baseline to postintervention.,"[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Fuller-Tyszkiewicz', 'Affiliation': 'Deakin University, Geelong, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': 'Nous Group, Melbourne, Australia.'}, {'ForeName': 'Keriann', 'Initials': 'K', 'LastName': 'Little', 'Affiliation': 'Deakin University, Geelong, Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Teague', 'Affiliation': 'Deakin University, Geelong, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Hartley-Clark', 'Affiliation': 'Deakin University, Geelong, Australia.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Capic', 'Affiliation': 'Deakin University, Geelong, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Khor', 'Affiliation': 'Deakin University, Geelong, Australia.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Cummins', 'Affiliation': 'Deakin University, Geelong, Australia.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Olsson', 'Affiliation': 'Deakin University, Geelong, Australia.'}, {'ForeName': 'Delyse', 'Initials': 'D', 'LastName': 'Hutchinson', 'Affiliation': 'Deakin University, Geelong, Australia.'}]",JMIR mental health,['10.2196/17541']
1630,32707403,"Changes to stance limb peak, cumulative, and regional plantar foot forces among normal walking and three mobility aids in healthy older adults.","BACKGROUND


Mobility aids are commonly prescribed to offload an injured lower extremity. Device selection may impact stance foot loading patterns and foot health in clinical populations at risk of foot ulceration.
RESEARCH QUESTIONS


Two questions motivated this study: How does device selection influence peak plantar and regional (rearfoot, mid foot and forefoot) foot forces on the stance foot? Does device selection influence peak, cumulative, and regional plantar forces within a 200 m walking trial?
METHODS


Twenty-one older adults walked 200 m at self-selected pace in four randomized conditions for this prospective crossover study. Participants used a walker, crutches, wheeled knee walker (WKW), and no assistive device (control condition). Plantar forces were measured using a wireless in-shoe system (Loadsol, Novel Inc., St. Paul, MN). Repeated measures analyses of variance were used to determine differences in peak and cumulative total and regional forces among walking conditions. Paired sample t-tests compared forces during first and last 30 s epochs of each condition to determine device influence over time.
RESULTS


The WKW reduced peak net forces by 0.29 and 0.35 bodyweight (BW) when compared to the walker or control condition with similar trends in all foot regions. Crutch use had similar peak forces as control. There were no differences in the number of steps taken within devices comparing first and last epochs. Crutches had a 0.04 and 0.07 BW increase in peak net and forefoot forces during the last epoch. Walker use had 66.44 BW lower cumulative forefoot forces in the last epoch.
SIGNIFICANCE


Crutches had similar stance foot loading as normal walking while a walker lowered forefoot forces at the expense of increased steps. A WKW may be the best choice to 'protect' tissues in the stance foot from exposure to peak and cumulative forces in the forefoot region.",2020,The WKW reduced peak net forces by 0.29 and 0.35 bodyweight (BW) when compared to the walker or control condition with similar trends in all foot regions.,"['healthy older adults', 'Twenty-one older adults walked 200 m at self-selected pace']",['normal walking and three mobility aids'],"['device selection influence peak, cumulative, and regional plantar forces', 'peak net forces', 'Plantar forces', 'peak net and forefoot forces', 'stance limb peak, cumulative, and regional plantar foot forces', 'peak and cumulative total and regional forces among walking conditions', 'cumulative forefoot forces']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C3495449', 'cui_str': 'Mobility aid'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C1510667', 'cui_str': 'Forefoot region of foot'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",21.0,0.0456241,The WKW reduced peak net forces by 0.29 and 0.35 bodyweight (BW) when compared to the walker or control condition with similar trends in all foot regions.,"[{'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Kingston', 'Affiliation': 'College of Medicine, University of Saskatchewan, 107 Wiggins Rd, Saskatoon, SK, S7N 5E5, Canada. Electronic address: david.kingston@usask.ca.'}, {'ForeName': 'A Gary', 'Initials': 'AG', 'LastName': 'Linassi', 'Affiliation': 'College of Medicine, University of Saskatchewan, 107 Wiggins Rd, Saskatoon, SK, S7N 5E5, Canada; School of Rehabilitation Science, University of Saskatchewan, Suite 3400, 3rd Floor, 104 Clinic Pl, Saskatoon, SK, S7N 2Z4, Canada. Electronic address: anl931@mail.usask.ca.'}, {'ForeName': 'Audrey R', 'Initials': 'AR', 'LastName': 'Zucker-Levin', 'Affiliation': 'School of Rehabilitation Science, University of Saskatchewan, Suite 3400, 3rd Floor, 104 Clinic Pl, Saskatoon, SK, S7N 2Z4, Canada. Electronic address: audrey.zuckerlevin@usask.ca.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.015']
1631,32710888,Effects of Ramadan intermittent fasting on inflammatory and biochemical biomarkers in males with obesity.,"BACKGROUND


To determine the effects of Ramadan intermittent fasting (RIF) on inflammatory (C-reactive protein (CRP), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α)) and biochemical markers of liver-renal function (aspartate aminotransferase (AST), alanine amino transferase (ALT), bilirubin, lactate dehydrogenase (LDH), urea and creatinine) in males with obesity.
MATERIALS AND METHODS


Twenty-eight males with obesity were randomly allocated to an experimental group (EG, n = 14) or a control group (CG, n = 14). The EG group completed their fasting rituals for the entire month of Ramadan (30 days) whereas the CG group continued with their normal daily habits. Blood samples were collected 24 h before the start of Ramadan (T0), on the 15th day of Ramadan (T1), the day after the end of Ramadan (T2), and 21 days after the end of Ramadan (T3). Resting plasma volume variation between pre and post-RIF (ΔPV) was calculated.
RESULTS


Decreases were noted for interleukin-6 (p = 0.02, d = 1.4) and tumor necrosis factor-alpha (p = 0.01, d = 0.7), with no changes for C-reactive protein (p = 0.3; d = 0.1) in the EG compared to CG group. There were no changes (P > 0.05) in ΔPV recorded after RIF for either EG (-0.035 ± 0.02%) and CG (0.055 ± 0.06%).
CONCLUSION


This study demonstrates that RIF improves systemic inflammation biomarkers in males with obesity. Moreover, RIF did not negatively affect biomarkers of liver and renal function.",2020,"RESULTS


Decreases were noted for interleukin-6 (p = 0.02, d = 1.4) and tumor necrosis factor-alpha (p = 0.01, d = 0.7), with no changes for C-reactive protein (p = 0.3; d=0.1) in the EG compared to CG group.","['males with obesity', 'Twenty-eight males with obesity']","['Ramadan intermittent fasting', 'Ramadan intermittent fasting (RIF', 'RIF']","['systemic inflammation biomarkers', 'inflammatory (C-reactive protein (CRP), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α)) and biochemical markers of liver-renal function (aspartate aminotransferase (AST), alanine amino transferase (ALT), bilirubin, lactate dehydrogenase (LDH), urea and creatinine', 'Blood samples', 'biomarkers of liver and renal function', 'inflammatory and biochemical biomarkers', 'tumor necrosis factor-alpha']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0057041', 'cui_str': 'D-amino-acid transaminase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}]",28.0,0.0245917,"RESULTS


Decreases were noted for interleukin-6 (p = 0.02, d = 1.4) and tumor necrosis factor-alpha (p = 0.01, d = 0.7), with no changes for C-reactive protein (p = 0.3; d=0.1) in the EG compared to CG group.","[{'ForeName': 'Hassane', 'Initials': 'H', 'LastName': 'Zouhal', 'Affiliation': 'Univ Rennes, M2S (Laboratoire Mouvement, Sport, Santé) - EA 1274, F-35000 Rennes, France. Electronic address: hassane.zouhal@univ-rennes2.fr.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Department of Exercise Physiology, University of Isfahan, Isfahan, Iran.'}, {'ForeName': 'Damoon', 'Initials': 'D', 'LastName': 'Ashtary-Larky', 'Affiliation': 'Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Alexei', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Department of Health and Human Performance, Marymount University, Arlington, USA.'}, {'ForeName': 'Raoua', 'Initials': 'R', 'LastName': 'Triki', 'Affiliation': 'ISSEP Ksar Said, University of Manouba, Tunis, Tunisia.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Hackney', 'Affiliation': 'Department of Exercise & Sport Science, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Laher', 'Affiliation': 'Department of Anesthesiology, Pharmacology and Therapeutics, The University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Abderraouf Ben', 'Initials': 'AB', 'LastName': 'Abderrahman', 'Affiliation': 'ISSEP Ksar Said, University of Manouba, Tunis, Tunisia.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113090']
1632,32716299,An mHealth Intervention (ReZone) to Help Young People Self-Manage Overwhelming Feelings: Cluster-Randomized Controlled Trial.,"BACKGROUND


Mental health difficulties in young people are increasing, and there is a need for evidence on the effectiveness of digital interventions to increase opportunities for supporting mental health in young people. Such studies are complicated due to issues of implementation and adoption, outcome measurement, and appropriate study designs.
OBJECTIVE


The objective of this study was to examine the effectiveness of an mHealth intervention (ReZone) in reducing mental health difficulties in young people.
METHODS


The cluster-randomized controlled trial enrolled 409 participants aged 10-15 years, and classes were allocated to ReZone or management as usual. Self-reported questionnaires were completed at baseline and 3-month follow-up.
RESULTS


There were no significant differences between the ReZone condition and management as usual in the self-reported outcome measures. However, there were 3467 usage sessions, which corresponds to 16.9 times per student (total of 205 students) in classes allocated to ReZone.
CONCLUSIONS


It is essential to publish studies that do not show significant differences, as these findings can still contribute to the literature, help in learning, and inform the direction of future work. The results reported in this paper could be due to a range of reasons, including whether ReZone has the scope to impact change or limitations related to the setting, context, and appropriateness of an RCT. The findings of this study suggest that ReZone was implemented and adopted.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


RR2-10.2196/resprot.7019.",2020,There were no significant differences between the ReZone condition and management as usual in the self-reported outcome measures.,"['Young People', 'young people', '409 participants aged 10-15 years, and classes']","['mHealth Intervention (ReZone', 'mHealth intervention (ReZone']",['mental health difficulties'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",409.0,0.0945038,There were no significant differences between the ReZone condition and management as usual in the self-reported outcome measures.,"[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Edridge', 'Affiliation': 'Clinical, Educational and Health Psychology, University College London, London, United Kingdom.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Wolpert', 'Affiliation': 'Clinical, Educational and Health Psychology, University College London, London, United Kingdom.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Deighton', 'Affiliation': 'Clinical, Educational and Health Psychology, University College London, London, United Kingdom.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Edbrooke-Childs', 'Affiliation': 'Clinical, Educational and Health Psychology, University College London, London, United Kingdom.'}]",Journal of medical Internet research,['10.2196/14223']
1633,32716303,Evaluating the Effects of a Mobile Health App on Reducing Patient Care Needs and Improving Quality of Life After Oral Cancer Surgery: Quasiexperimental Study.,"BACKGROUND


Intervention with a mobile Health (mHealth) app can improve the efficacy of early detection of oral cancer and the outcomes for patients taking oral anticancer medications. The quality of life of oral cancer patients is significantly reduced within three months after surgery; also, their needs for nursing care and health information increase, mainly due to side effects and associated psychological problems.
OBJECTIVE


This study aimed to evaluate changes in the care needs and quality of life of patients with oral cancer after receiving the intervention of a newly developed mHealth app.
METHODS


After surgery, oral cancer patients were divided into an experimental group (n=50) who received the mHealth app intervention and a control group (n=50) who received routine health care and instruction. After 3 months of intervention, survey questionnaires were used to assess the patients' quality of life, nursing care needs, and acceptance of the mHealth app.
RESULTS


The physiological care needs were significantly decreased in the experimental group compared with the control group (P<.05). Although the differences were not statistically significant, the psychological needs, communication needs, and care support needs all improved after the mHealth app intervention. The overall improvement in quality of life was higher in the experimental group than in the control group (-7.24 vs -4.36). In terms of intention to use, perceived usefulness, and perceived ease of use, the acceptability scores of the mHealth app were significantly increased after 3 months of intervention (P<.05).
CONCLUSIONS


Compared with routine health care and instruction, for patients after surgery, the education/information intervention using the mHealth app significantly reduced their nursing care needs, improved their quality of life, and increased their acceptance of using an mHealth app on a mobile device. These findings can provide a theoretical basis for future health care app design and improvement. This study suggests that an mHealth app should be incorporated into the routine care of oral cancer patients to provide medical information quickly and improve their self-management abilities, thereby reducing the patients' need for physiological care and improving their quality of life.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04049968; https://www.clinicaltrials.gov/ct2/show/NCT04049968.",2020,The overall improvement in quality of life was higher in the experimental group than in the control group (-7.24 vs -4.36).,"['After surgery, oral cancer patients', 'patients with oral cancer after receiving the intervention of a newly developed mHealth app', 'patients taking oral anticancer medications', 'oral cancer patients']","['Mobile Health App', 'mHealth app intervention and a control group (n=50) who received routine health care and instruction']","['quality of life', 'acceptability scores of the mHealth app', ""patients' quality of life, nursing care needs, and acceptance of the mHealth app"", 'psychological needs, communication needs, and care support needs', 'quality of life of oral cancer patients', 'Patient Care Needs and Improving Quality of Life']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028678', 'cui_str': 'nursing'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0153381', 'cui_str': 'Malignant tumor of oral cavity'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0657756,The overall improvement in quality of life was higher in the experimental group than in the control group (-7.24 vs -4.36).,"[{'ForeName': 'Tze-Fang', 'Initials': 'TF', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, National Yang-Ming University, Taipei City, Taiwan.'}, {'ForeName': 'Rou-Chen', 'Initials': 'RC', 'LastName': 'Huang', 'Affiliation': 'School of Nursing, National Yang-Ming University, Taipei City, Taiwan.'}, {'ForeName': 'Su-Chen', 'Initials': 'SC', 'LastName': 'Yang', 'Affiliation': 'Department of Nursing, Far Eastern Memorial Hospital, New Taipei City, Taiwan.'}, {'ForeName': 'Chyuan', 'Initials': 'C', 'LastName': 'Chou', 'Affiliation': 'Excellent Dental Center, Taipei City, Taiwan.'}, {'ForeName': 'Lee-Chen', 'Initials': 'LC', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Far Eastern Memorial Hospital, New Taipei City, Taiwan.'}]",JMIR mHealth and uHealth,['10.2196/18132']
1634,32711724,Personalised haemodynamic management targeting baseline cardiac index in high-risk patients undergoing major abdominal surgery: a randomised single-centre clinical trial.,"BACKGROUND


Despite several clinical trials on haemodynamic therapy, the optimal intraoperative haemodynamic management for high-risk patients undergoing major abdominal surgery remains unclear. We tested the hypothesis that personalised haemodynamic management targeting each individual's baseline cardiac index at rest reduces postoperative morbidity.
METHODS


In this single-centre trial, 188 high-risk patients undergoing major abdominal surgery were randomised to either routine management or personalised haemodynamic management requiring clinicians to maintain personal baseline cardiac index (determined at rest preoperatively) using an algorithm that guided intraoperative i.v. fluid and/or dobutamine administration. The primary outcome was a composite of major complications (European Perioperative Clinical Outcome definitions) or death within 30 days of surgery. Secondary outcomes included postoperative morbidity (assessed by a postoperative morbidity survey), hospital length of stay, mortality within 90 days of surgery, and neurocognitive function assessed after postoperative Day 3.
RESULTS


The primary outcome occurred in 29.8% (28/94) of patients in the personalised management group, compared with 55.3% (52/94) of patients in the routine management group (relative risk: 0.54, 95% confidence interval [CI]: 0.38 to 0.77; absolute risk reduction: -25.5%, 95% CI: -39.2% to -11.9%; P<0.001). One patient assigned to the personalised management group, compared with five assigned to the routine management group, died within 30 days after surgery (P=0.097). There were no clinically relevant differences between the two groups for secondary outcomes.
CONCLUSIONS


In high-risk patients undergoing major abdominal surgery, personalised haemodynamic management reduces a composite outcome of major postoperative complications or death within 30 days after surgery compared with routine care.
CLINICAL TRIAL REGISTRATION


NCT02834377.",2020,"In high-risk patients undergoing major abdominal surgery, personalised haemodynamic management reduces a composite outcome of major postoperative complications or death within 30 days after surgery compared with routine care.
","['188 high-risk patients undergoing major abdominal surgery', 'high-risk patients undergoing major abdominal surgery']","['Personalised haemodynamic management', 'routine management or personalised haemodynamic management requiring clinicians to maintain personal baseline cardiac index (determined at rest preoperatively) using an algorithm that guided intraoperative i.v']","['postoperative morbidity (assessed by a postoperative morbidity survey), hospital length of stay, mortality within 90 days of surgery, and neurocognitive function assessed after postoperative Day 3', 'composite of major complications (European Perioperative Clinical Outcome definitions) or death within 30 days of surgery', 'major postoperative complications or death']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3887296', 'cui_str': 'Within thirty days of surgery'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",188.0,0.326373,"In high-risk patients undergoing major abdominal surgery, personalised haemodynamic management reduces a composite outcome of major postoperative complications or death within 30 days after surgery compared with routine care.
","[{'ForeName': 'Julia Y', 'Initials': 'JY', 'LastName': 'Nicklas', 'Affiliation': 'Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine. Electronic address: j.nicklas@uke.de.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Diener', 'Affiliation': 'Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Leistenschneider', 'Affiliation': 'Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Sellhorn', 'Affiliation': 'Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schön', 'Affiliation': 'Department of Medical Biometry and Epidemiology.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Winkler', 'Affiliation': 'Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine.'}, {'ForeName': 'Guenter', 'Initials': 'G', 'LastName': 'Daum', 'Affiliation': 'Clinic and Polyclinic for Vascular Medicine, University Heart Center.'}, {'ForeName': 'Edzard', 'Initials': 'E', 'LastName': 'Schwedhelm', 'Affiliation': 'Institute of Clinical Pharmacology and Toxicology.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Schröder', 'Affiliation': 'Department of Neurology.'}, {'ForeName': 'Margit', 'Initials': 'M', 'LastName': 'Fisch', 'Affiliation': 'Department of Urology.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Schmalfeldt', 'Affiliation': 'Department of Gynecology and Gynecologic Oncology.'}, {'ForeName': 'Jakob R', 'Initials': 'JR', 'LastName': 'Izbicki', 'Affiliation': 'General-, Visceral and Thoracic Surgery Department and Clinic, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine.'}, {'ForeName': 'Sina M', 'Initials': 'SM', 'LastName': 'Coldewey', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine; Septomics Research Center, Center for Sepsis Control and Care, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Reuter', 'Affiliation': 'Department of Anesthesiology, Rostock University Medical Center, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Saugel', 'Affiliation': 'Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine; Outcomes Research Consortium, Cleveland, OH, USA.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.04.094']
1635,32713115,A multicenter prospective randomized controlled trial for preoperative biliary drainage with uncovered metal versus plastic stents for resectable periampullary cancer.,"BACKGROUND/PURPOSE


Although routine preoperative biliary drainage (PBD) in patients with distal malignant biliary obstruction is generally not recommended, there are still various situations where it may be necessary. The current study aims to compare the uncovered self-expandable metal stent (uSEMS) and plastic stent (PS), where PBD may be necessary.
PATIENTS AND METHODS


In this multicenter prospective randomized study, patients with resectable periampullary cancer with cholangitis, deep jaundice, or expected long waiting time for surgery were included. PBD was performed endoscopically, but percutaneous drainage was allowed if the initial endoscopic drainage was not feasible. The primary outcome was the reintervention rate; the secondary outcomes were the complication rates, rate of decrease of total bilirubin, waiting time for surgery, and postoperative hospital stay.
RESULTS


Of the 60 enrolled patients, 53 were included for analysis (26 PS and 27 uSEMS). Common bile duct cancer was the most common (27, 50.9%), followed by pancreatic head cancer (20, 37.7%). Regarding PBD indication, 36 (67.9%) had cholangitis and 21 (39.6%) had a total bilirubin level of more than 10 mg/dL at randomization; 10 (18.9%) were included due to delayed surgery by more than 7 days. Fifty (94.3%) patients received pancreaticoduodenectomy, and one (1.9%) patient received palliative hepaticojejunostomy. The median waiting time for surgery was 11.0 days. There was no difference in the reintervention rate (3.8% and 3.8% in PS and uSEMS, P > .999), PBD-related complication rate (23.1% and 22.2%, P > .999), PBD- or surgery-related complication rate (57.7% and 48.1%, P = .674), and the rate of decrease of total bilirubin (P = .541). The median hospital stay after surgery was 13.0 days without significant difference.
CONCLUSION


For patients who received surgery within the first 2 weeks from receiving PBD, there was no superiority of uSEMS to PS. According to the expected waiting time for surgery, selective approach for stent choice should be considered.",2020,"There was no difference in the reintervention rate (3.8% and 3.8% in PS and uSEMS, P > 0.999), PBD-related complication rate (23.1% and 22.2%, P > 0.999), PBD- or surgery-related complication rate (57.7% and 48.1%, P = 0.674), and the rate of decrease of total bilirubin (P=0.541).","['60 enrolled patients, 53 were included for analysis (26 PS and 27 uSEMS', 'patients with distal malignant biliary obstruction', 'patients with resectable periampullary cancer with cholangitis, deep jaundice, or expected long waiting time for surgery were included', 'Resectable Periampullary Cancer']","['Preoperative Biliary Drainage with Uncovered Metal versus Plastic Stents', 'pancreaticoduodenectomy', 'self-expandable metal stent (uSEMS) and plastic stent (PS', 'routine preoperative biliary drainage (PBD', 'palliative hepaticojejunostomy', 'PBD']","['rate of decrease of total bilirubin', 'complication rates, rate of decrease of total bilirubin, waiting time for surgery, and postoperative hospital stay', 'median waiting time', 'PBD-related complication rate', 'median hospital stay', 'reintervention rate', 'PBD- or surgery-related complication rate', 'total bilirubin level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0441289', 'cui_str': 'Plastic stent'}, {'cui': 'C0439845', 'cui_str': 'Uncovered'}, {'cui': 'C4042807', 'cui_str': 'Self Expandable Metallic Stent'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C3898473', 'cui_str': 'Malignant biliary obstruction'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008311', 'cui_str': 'Cholangitis'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0022346', 'cui_str': 'Jaundice'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0441289', 'cui_str': 'Plastic stent'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C4042807', 'cui_str': 'Self Expandable Metallic Stent'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0193425', 'cui_str': 'Hepatojejunostomy'}]","[{'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0400745', 'cui_str': 'Biliary drainage'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement'}]",60.0,0.309048,"There was no difference in the reintervention rate (3.8% and 3.8% in PS and uSEMS, P > 0.999), PBD-related complication rate (23.1% and 22.2%, P > 0.999), PBD- or surgery-related complication rate (57.7% and 48.1%, P = 0.674), and the rate of decrease of total bilirubin (P=0.541).","[{'ForeName': 'Jae Hee', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yoo-Seok', 'Initials': 'YS', 'LastName': 'Yoon', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hosptial, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Eui Joo', 'Initials': 'EJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Yeon Suk', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Jai Young', 'Initials': 'JY', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hosptial, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Ho-Seong', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hosptial, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Yeon Ho', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Dong Woo', 'Initials': 'DW', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu, Korea.'}, {'ForeName': 'Jong-Chan', 'Initials': 'JC', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hosptial, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Jin-Hyeok', 'Initials': 'JH', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hosptial, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Jaihwan', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hosptial, Seoul National University College of Medicine, Seongnam, Korea.'}]",Journal of hepato-biliary-pancreatic sciences,['10.1002/jhbp.811']
1636,32721578,The home air in agriculture pediatric intervention (HAPI) trial: Rationale and methods.,"BACKGROUND


Data addressing air quality effects on children with asthma in rural U.S. communities are rare. Our community engaged research partnership previously demonstrated associations between neighborhood NH 3  and ambient PM 2.5  and asthma in the agricultural lower Yakima Valley of Washington. As a next step, the partnership desired an intervention approach to address concerns about pediatric asthma in this largely Latino immigrant, farm worker community.
OBJECTIVE


The Home Air in Agriculture Pediatric Intervention (HAPI) sought to examine the effectiveness of enrichment of an existing asthma education program with portable high-efficiency particulate air (HEPA) cleaners designed to reduce PM 2.5  and NH 3.  We investigated the effect of this enriched approach on these exposures and asthma health measures.
DESIGN


We randomized children with poorly controlled asthma to a control arm (current asthma education program) or an intervention arm (current asthma education program + placement of two indoor air cleaners in the family's home). Outcomes included (1) 14-day integrated samples of indoor air contaminants (PM 2.5  and NH 3 ) at baseline and one-year follow-up and (2) child asthma health metrics at baseline, midpoint (4-6 months) and one-year follow-up. These included the Asthma Control Test, symptoms days, clinical utilization, oral corticosteroid use, pulmonary function, fractional exhaled nitric oxide, and urinary leukotriene E 4  concentration.
DISCUSSION


To our knowledge, this is the first randomized HEPA cleaner intervention designed to assess NH 3  as well as PM 2.5  and to evaluate health outcomes of children with asthma in an agricultural region.",2020,"OBJECTIVE


The Home Air in Agriculture Pediatric Intervention (HAPI) sought to examine the effectiveness of enrichment of an existing asthma education program with portable high-efficiency particulate air (HEPA) cleaners designed to reduce PM 2.5  and NH 3.  ","['children with asthma in rural U.S. communities', 'children with asthma in an agricultural region', 'children with poorly controlled asthma to a control arm (current asthma education program) or an']","[""intervention arm (current asthma education program + placement of two indoor air cleaners in the family's home""]","['14-day integrated samples of indoor air contaminants (PM 2.5  and NH 3 ) at baseline and one-year follow-up and (2) child asthma health metrics', 'Asthma Control Test, symptoms days, clinical utilization, oral corticosteroid use, pulmonary function, fractional exhaled nitric oxide, and urinary leukotriene E 4  concentration']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0789995', 'cui_str': 'Air cleaner'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0337099', 'cui_str': 'Air contaminant'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C4704932', 'cui_str': 'Health Metrics'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0125644', 'cui_str': 'LTE4'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0221442,"OBJECTIVE


The Home Air in Agriculture Pediatric Intervention (HAPI) sought to examine the effectiveness of enrichment of an existing asthma education program with portable high-efficiency particulate air (HEPA) cleaners designed to reduce PM 2.5  and NH 3.  ","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Masterson', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America. Electronic address: emaster@uw.edu.'}, {'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Younglove', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Perez', 'Affiliation': ""Yakima Valley Farm Worker's Clinic, Toppenish, WA, United States of America.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Torres', 'Affiliation': 'Northwest Communities Education Center, Radio KDNA, Granger, WA, United States of America.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Krenz', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Tchong French', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Riederer', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Sampson', 'Affiliation': 'Department of Statistics, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Nervana', 'Initials': 'N', 'LastName': 'Metwali', 'Affiliation': 'Department of Occupational and Environmental Health, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Min', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jansen', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Gino', 'Initials': 'G', 'LastName': 'Aisenberg', 'Affiliation': 'School of Social Work, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Ryan S', 'Initials': 'RS', 'LastName': 'Babadi', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Farquhar', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America; Department of Health Services, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Thorne', 'Affiliation': 'Department of Occupational and Environmental Health, University of Iowa, Iowa City, IA, United States of America.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Karr', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, United States of America; Department of Pediatrics, University of Washington, Seattle, WA, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106085']
1637,32721655,Do ethics classes influence student behavior? Case study: Teaching the ethics of eating meat.,"Do university ethics classes influence students' real-world moral choices? We aimed to conduct the first controlled study of the effects of ordinary philosophical ethics classes on real-world moral choices, using non-self-report, non-laboratory behavior as the dependent measure. We assigned 1332 students in four large philosophy classes to either an experimental group on the ethics of eating meat or a control group on the ethics of charitable giving. Students in each group read a philosophy article on their assigned topic and optionally viewed a related video, then met with teaching assistants for 50-minute group discussion sections. They expressed their opinions about meat ethics and charitable giving in a follow-up questionnaire (1032 respondents after exclusions). We obtained 13,642 food purchase receipts from campus restaurants for 495 of the students, before and after the intervention. Purchase of meat products declined in the experimental group (52% of purchases of at least $4.99 contained meat before the intervention, compared to 45% after) but remained the same in the control group (52% both before and after). Ethical opinion also differed, with 43% of students in the experimental group agreeing that eating the meat of factory farmed animals is unethical compared to 29% in the control group. We also attempted to measure food choice using vouchers, but voucher redemption rates were low and no effect was statistically detectable. It remains unclear what aspect of instruction influenced behavior.",2020,"Purchase of meat products declined in the experimental group (52% of purchases of at least $4.99 contained meat before the intervention, compared to 45% after) but remained the same in the control group (52% both before and after).",['1332 students in four large philosophy classes to either an experimental group on the ethics of eating meat or a control group on the ethics of charitable giving'],['ordinary philosophical ethics classes'],['Purchase of meat products'],"[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0031534', 'cui_str': 'Philosophy'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0025018', 'cui_str': 'Meat products'}]",1332.0,0.0290026,"Purchase of meat products declined in the experimental group (52% of purchases of at least $4.99 contained meat before the intervention, compared to 45% after) but remained the same in the control group (52% both before and after).","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Schwitzgebel', 'Affiliation': 'University of California at Riverside, USA. Electronic address: eschwitz@ucr.edu.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Cokelet', 'Affiliation': 'University of Kansas, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Singer', 'Affiliation': 'Princeton University, USA.'}]",Cognition,['10.1016/j.cognition.2020.104397']
1638,32721923,Correction: Effectiveness of a Web-Based Tailored Intervention With Virtual Assistants Promoting the Acceptability of HPV Vaccination Among Mothers of Invited Girls: Randomized Controlled Trial.,[This corrects the article DOI: .].,2020,[This corrects the article DOI: .].,['Mothers of Invited Girls'],[],"['Vaccination', 'Acceptability of HPV']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}]",,0.124551,[This corrects the article DOI: .].,"[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Pot', 'Affiliation': 'Netherlands Organization for Applied Scientific Research (TNO), Child Health, Leiden, Netherlands.'}, {'ForeName': 'Theo Gwm', 'Initials': 'TG', 'LastName': 'Paulussen', 'Affiliation': 'Netherlands Organization for Applied Scientific Research (TNO), Child Health, Leiden, Netherlands.'}, {'ForeName': 'Robert Ac', 'Initials': 'RA', 'LastName': 'Ruiter', 'Affiliation': 'Department of Work and Social Psychology, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Eekhout', 'Affiliation': 'Netherlands Organization for Applied Scientific Research (TNO), Child Health, Leiden, Netherlands.'}, {'ForeName': 'Hester E', 'Initials': 'HE', 'LastName': 'de Melker', 'Affiliation': 'National Institute for Public Health and the Environment (RIVM), Centre for Infectious Disease Control, Bilthoven, Netherlands.'}, {'ForeName': 'Maxine Ea', 'Initials': 'ME', 'LastName': 'Spoelstra', 'Affiliation': 'Department of Psychology, Leiden University, Leiden, Netherlands.'}, {'ForeName': 'Hilde M', 'Initials': 'HM', 'LastName': 'van Keulen', 'Affiliation': 'Netherlands Organization for Applied Scientific Research (TNO), Child Health, Leiden, Netherlands.'}]",Journal of medical Internet research,['10.2196/22565']
1639,32723393,Prevalence and abundance of selected genes conferring macrolide resistance genes in COPD patients during maintenance treatment with azithromycin.,"OBJECTIVES


Maintenance treatment with macrolide antibiotics has shown to be effective in reducing exacerbations in COPD patients. A major concern with prolonged treatment with antibiotics is the development of bacterial resistance. In this study we determined the effect of azithromycin on the development and acquisition of resistance to macrolides in the nasopharyngeal flora in COPD patients.
METHODS


This study was part of the COLUMBUS trial, a randomised, double-blind, placebo-controlled trial to measure the effect of maintenance treatment with azithromycin in 92 COPD patients on the exacerbation rates during a 12-month period. In order to determine resistance to macrolides, we used a targeted metagenomic approach to measure the presence and relative abundance of specific macrolide resistance genes ermB, ermF and mefA in throat samples collected at different time-points during this 12-month period.
RESULTS


There was no increased risk for acquisition of macrolide resistance genes in the azithromycin group compared to the placebo group in COPD patients. However, loss of the macrolide resistance gene ermB was increased overtime in the placebo treated group compared to the azithromycin group (n = 5 for the placebo group versus n = 0 for the azithromycin group at 12 months; p = 0.012). The change in relative abundance of the three macrolide-resistance genes showed that all but one (ermF) increased during treatment with azithromycin.
CONCLUSIONS


The acquisition rate of macrolide resistance genes in COPD patients treated with azithromycin maintenance therapy was limited, but the relative abundance of macrolide resistance genes increased significantly over time compared to placebo. This study was part of the COLUMBUS trial ( Clinicaltrials.gov , NCT00985244 ).",2020,There was no increased risk for acquisition of macrolide resistance genes in the azithromycin group compared to the placebo group in COPD patients.,"['COPD patients during maintenance treatment with', 'COPD patients treated with', 'COPD patients', '92 COPD patients on the exacerbation rates during a 12-month period']","['macrolide antibiotics', 'azithromycin', 'azithromycin maintenance therapy', 'placebo']","['risk for acquisition of macrolide resistance genes', 'loss of the macrolide resistance gene ermB', 'relative abundance of macrolide resistance genes', 'acquisition rate of macrolide resistance genes']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0003240', 'cui_str': 'Macrolide antibiotic product'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0003240', 'cui_str': 'Macrolide antibiotic product'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",92.0,0.237699,There was no increased risk for acquisition of macrolide resistance genes in the azithromycin group compared to the placebo group in COPD patients.,"[{'ForeName': 'Remco S', 'Initials': 'RS', 'LastName': 'Djamin', 'Affiliation': 'Department t of Respiratory Medicine, Amphia Hospital, Molengracht 21, 4818 CK, Breda, The Netherlands.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Talman', 'Affiliation': 'Department t of Respiratory Medicine, Amphia Hospital, Molengracht 21, 4818 CK, Breda, The Netherlands. STalman@amphia.nl.'}, {'ForeName': 'Eefje J A', 'Initials': 'EJA', 'LastName': 'Schrauwen', 'Affiliation': 'Laboratory for Microbiology and Infection Control, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Christian J H', 'Initials': 'CJH', 'LastName': 'von Wintersdorff', 'Affiliation': 'Department of Medical Microbiology, Maastricht University Medical Center+, Maastricht, The Netherlands.'}, {'ForeName': 'Petra F', 'Initials': 'PF', 'LastName': 'Wolffs', 'Affiliation': 'Department of Medical Microbiology, Maastricht University Medical Center+, Maastricht, The Netherlands.'}, {'ForeName': 'Paul H M', 'Initials': 'PHM', 'LastName': 'Savelkoul', 'Affiliation': 'Department of Medical Microbiology, Maastricht University Medical Center+, Maastricht, The Netherlands.'}, {'ForeName': 'Sevim', 'Initials': 'S', 'LastName': 'Uzun', 'Affiliation': 'Department t of Respiratory Medicine, Amphia Hospital, Molengracht 21, 4818 CK, Breda, The Netherlands.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Kerstens', 'Affiliation': 'Orion Statistical Consulting BV, Hilvarenbeek, The Netherlands.'}, {'ForeName': 'Menno M', 'Initials': 'MM', 'LastName': 'van der Eerden', 'Affiliation': 'Department of Respiratory Medicine, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Jan A J W', 'Initials': 'JAJW', 'LastName': 'Kluytmans', 'Affiliation': 'Laboratory for Microbiology and Infection Control, Amphia Hospital, Breda, The Netherlands.'}]",Antimicrobial resistance and infection control,['10.1186/s13756-020-00783-w']
1640,32723727,A Web-Based Program for Cannabis Use and Psychotic Experiences in Young People (Keep It Real): Protocol for a Randomized Controlled Trial.,"BACKGROUND


Young Australians (16-25 years) have the highest rates of past-month cannabis use in the world. Cannabis use increases the risk of alcohol and other drug disorders and depressive disorders, and has a robust dose-response association with psychotic experiences (PEs) and disorders. PEs are subthreshold positive psychotic symptoms, including delusions and hallucinations, which increase the risk of substance use, depressive or anxiety disorders, and psychotic disorders. Access to effective web-based early interventions targeting both cannabis use and PEs could reduce such risk in young people.
OBJECTIVE


The objective of this study is to determine the efficacy and cost-effectiveness of the Keep it Real web-based program compared to an information-only control website among young cannabis users (16-25 years) with PEs.
METHODS


Participants are recruited online, and consenting individuals meeting inclusion criteria (aged 16-25 years, who have used cannabis in the past month and experienced PEs in the past 3 months) are automatically randomized to either the Keep it Real web-based program (n=249) or an information-only control website (n=249). Both websites are self-guided (fully automated). The baseline and follow-up assessments at 3, 6, 9, and 12 months are self-completed online. Primary outcome measures are weekly cannabis use, PEs, and the relative cost-effectiveness for quality-adjusted life years. Secondary outcomes include other substance use and related problems, PE-related distress, cannabis intoxication experiences, severity of cannabis dependence, depression/anxiety symptoms, suicidality, and mental well-being and functioning.
RESULTS


Recruitment commenced in February 2019, and the results are expected to be submitted for publication in mid-2021.
CONCLUSIONS


This study protocol describes a large randomized controlled trial of a new web-based program for young cannabis users experiencing PEs. If effective, the accessibility and scalability of Keep it Real could help reduce growing public health concerns about the significant social, economic, and health impacts of cannabis use.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12618001107213; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=374800.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/15803.",2020,"Cannabis use increases the risk of alcohol and other drug disorders and depressive disorders, and has a robust dose-response association with psychotic experiences (PEs) and disorders.","['Young Australians (16-25 years', 'Participants are recruited online, and consenting individuals meeting inclusion criteria (aged 16-25 years, who have used cannabis in the past month and experienced PEs in the past 3 months', 'young cannabis users experiencing PEs', 'young people', 'young cannabis users (16-25 years) with PEs', 'Young People']",['Keep it Real web-based program (n=249) or an information-only control website'],"['weekly cannabis use, PEs, and the relative cost-effectiveness for quality-adjusted life years', 'efficacy and cost-effectiveness', 'substance use and related problems, PE-related distress, cannabis intoxication experiences, severity of cannabis dependence, depression/anxiety symptoms, suicidality, and mental well-being and functioning', 'risk of alcohol and other drug disorders and depressive disorders']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205171', 'cui_str': 'Singular'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0006872', 'cui_str': 'Cannabis sativa poisoning'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0006870', 'cui_str': 'Cannabis dependence'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}]",,0.128032,"Cannabis use increases the risk of alcohol and other drug disorders and depressive disorders, and has a robust dose-response association with psychotic experiences (PEs) and disorders.","[{'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': 'Lives Lived Well Group, National Centre for Youth Substance Use Research, School of Psychology, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Baker', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Norberg', 'Affiliation': 'Centre for Emotional Health, Department of Psychology, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Copeland', 'Affiliation': 'Sunshine Coast Mind and Neuroscience - Thompson Institute, University of the Sunshine Coast, Birtinya, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Quinn', 'Affiliation': 'Lives Lived Well Group, National Centre for Youth Substance Use Research, School of Psychology, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Walter', 'Affiliation': 'Lives Lived Well Group, National Centre for Youth Substance Use Research, School of Psychology, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Janni', 'Initials': 'J', 'LastName': 'Leung', 'Affiliation': 'Lives Lived Well Group, National Centre for Youth Substance Use Research, School of Psychology, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Stoyan R', 'Initials': 'SR', 'LastName': 'Stoyanov', 'Affiliation': 'Lives Lived Well Group, National Centre for Youth Substance Use Research, School of Psychology, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kavanagh', 'Affiliation': ""Centre for Youth Substance Abuse Research, Centre for Children's Health Research, Queensland University of Technology, Brisbane, Australia.""}]",JMIR research protocols,['10.2196/15803']
1641,32723728,Teens Taking Charge: A Randomized Controlled Trial of a Web-Based Self-Management Program With Telephone Support for Adolescents With Juvenile Idiopathic Arthritis.,"BACKGROUND


Juvenile idiopathic arthritis (JIA) is a serious and potentially debilitating pediatric illness. Improved disease self-management may help to improve health outcomes.
OBJECTIVE


This study aimed to evaluate the effectiveness of the Teens Taking Charge Web-based self-management intervention in reducing symptoms and improving health-related quality of life (HRQL) in adolescents with JIA compared with a Web-based education control condition.
METHODS


Adolescents with JIA aged 12 to 18 years were recruited from 11 Canadian pediatric rheumatology centers. Caregivers were invited to participate along with their child. In addition to standard medical care, participants were randomized to receive either (1) the Teens Taking Charge self-management intervention or (2) a Web-based education control condition for a period of 12 weeks. Adolescents in the intervention group completed website modules addressing cognitive behavioral coping skills, stress management, and other self-management topics, while also receiving monthly telephone calls from a trained health coach. Adolescents in the education control group were instructed to view a series of preselected public JIA educational websites and received monthly calls from a coach who asked about their own best efforts at managing JIA. Caregivers in the intervention group completed website modules related to promoting independence and disease self-management in their child. Caregivers in the education control group were instructed to view a series of preselected public JIA educational websites. Outcome assessment occurred at baseline, 12 weeks (posttreatment), and at 6 and 12 months postrandomization. The primary outcomes were pain intensity, pain interference, and HRQL. Secondary outcomes were emotional symptoms, adherence, coping, knowledge, and self-efficacy.
RESULTS


In total, 333 adolescents and 306 caregivers were enrolled. Significant overall reductions in pain intensity (P=.02) and pain interference (P=.007) were observed for intervention group participants compared with those in the education control group, after adjusting for baseline levels. There was a significant overall improvement in HRQL related to problems with pain (P=.02) and problems with daily activities (P=.01). There was also a significant difference in the intervention group over time (P=.008) for HRQL related to treatment problems, with the intervention group participants demonstrating improved HRQL by 12 months compared with education control group participants. Both groups showed nonsignificant improvements compared with baseline in other primary outcomes. There were no significant differences between the groups in any secondary outcomes or caregiver-reported outcomes.
CONCLUSIONS


The results of this randomized trial suggest that the Teens Taking Charge Web-based intervention is effective at reducing both pain intensity and pain interference, as well as improving HRQL in adolescents with JIA, compared with education control. These effects are sustained for up to 12 months following program completion. The Teens Taking Charge program is now publicly available at no cost.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01572896; https://clinicaltrials.gov/ct2/show/NCT01572896.",2020,"Significant overall reductions in pain intensity (P=.02) and pain interference (P=.007) were observed for intervention group participants compared with those in the education control group, after adjusting for baseline levels.","['adolescents with JIA compared with a Web-based education control condition', 'Adolescents with JIA aged 12 to 18 years were recruited from 11 Canadian pediatric rheumatology centers', '333 adolescents and 306 caregivers were enrolled', 'Adolescents With Juvenile Idiopathic Arthritis', 'Teens Taking Charge']","['Web-Based Self-Management Program With Telephone Support', 'website modules addressing cognitive behavioral coping skills, stress management, and other self-management topics, while also receiving monthly telephone calls from a trained health coach', 'Teens Taking Charge Web-based self-management intervention', 'preselected public JIA educational websites and received monthly calls from a coach who asked about their own best efforts at managing JIA', 'Teens Taking Charge self-management intervention or (2) a Web-based education control condition']","['symptoms and improving health-related quality of life (HRQL', 'pain intensity, pain interference, and HRQL', 'pain intensity', 'emotional symptoms, adherence, coping, knowledge, and self-efficacy', 'HRQL', 'pain interference', 'pain intensity and pain interference']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1621271', 'cui_str': 'Pediatric rheumatology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4517724', 'cui_str': '333'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0007961', 'cui_str': 'Charges'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C1172410', 'cui_str': 'ASK protein, human'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",333.0,0.115157,"Significant overall reductions in pain intensity (P=.02) and pain interference (P=.007) were observed for intervention group participants compared with those in the education control group, after adjusting for baseline levels.","[{'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Stinson', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Lalloo', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Amos S', 'Initials': 'AS', 'LastName': 'Hundert', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Campillo', 'Affiliation': ""Montreal Children's Hospital, Montreal, QC, Canada.""}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Cellucci', 'Affiliation': 'Department of Pediatrics, Division of Rheumatology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dancey', 'Affiliation': ""Department of Pediatrics, Division of Rheumatology, Memorial University of Newfoundland, St. John's, NL, Canada.""}, {'ForeName': 'Ciaran', 'Initials': 'C', 'LastName': 'Duffy', 'Affiliation': 'Department of Pediatrics, Division of Rheumatology, McGill Research Institute, Montreal, QC, Canada.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Ellsworth', 'Affiliation': 'Department of Pediatrics, Division of Rheumatology, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Feldman', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Huber', 'Affiliation': 'IWK Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Johnson', 'Affiliation': ""Alberta Children's Hospital, Calgary, AB, Canada.""}, {'ForeName': ""Geert't"", 'Initials': 'G', 'LastName': 'Jong', 'Affiliation': ""Children's Hospital Research Institute of Manitoba, Winnipeg, MB, Canada.""}, {'ForeName': 'Kiem', 'Initials': 'K', 'LastName': 'Oen', 'Affiliation': 'Pediatrics and Child Health, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Alan M', 'Initials': 'AM', 'LastName': 'Rosenberg', 'Affiliation': 'University of Saskatchewan, Saskatoon, SK, Canada.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Shiff', 'Affiliation': 'Biobehavioral Nursing Science, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Spiegel', 'Affiliation': 'Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Shirley M L', 'Initials': 'SML', 'LastName': 'Tse', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Tucker', 'Affiliation': 'Department of Pediatrics, Division of Rheumatology, University of British Columbia, Vancouver, ON, Canada.'}, {'ForeName': 'Joseph Charles', 'Initials': 'JC', 'LastName': 'Victor', 'Affiliation': 'Institute for Clinical Evaluative Sciences, Toronto, ON, Canada.'}]",Journal of medical Internet research,['10.2196/16234']
1642,32689975,"A phase IV randomised, open-label pilot study to evaluate switching from protease-inhibitor based regimen to Bictegravir/Emtricitabine/Tenofovir Alafenamide single tablet regimen in Integrase inhibitor-naïve, virologically suppressed HIV-1 infected adults harbouring drug resistance mutations (PIBIK study): study protocol for a randomised trial.","BACKGROUND


Currently recommended boosted protease-inhibitor (bPI) regimens may be associated with increased risk of cardiovascular or chronic kidney diseases; in addition, boosted regimens are particularly associated with drug-drug interactions. Since both cardiovascular and renal disease, and polypharmacy, are common in ageing people with HIV, there is a need for alternative efficacious regimens. bPI-based regimens are often the treatment of choice for individuals with pre-treatment or treatment-acquired resistance but it is plausible that carefully selected HIV-positive individuals with drug resistance, who are virologically suppressed on their current bPI regimen, could maintain virological efficacy when switched to bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF) fixed dose combination (FDC).
METHODS/DESIGN


A phase IV, investigator-initiated, multicentre, open label pilot, randomised two-arm study to assess the safety and efficacy of switching from bPI regimen to B/F/TAF single tablet regimen in integrase inhibitor-naïve, virologically suppressed adults with HIV-1 infection harbouring drug resistance mutations. Eligible individuals will either continue on their bPI regimen or switch to B/F/TAF FDC. After 24 weeks, all participants in the bPI arm will be switched to B/F/TAF and followed for a further 24 weeks and all participants will be followed for 48 weeks. The primary efficacy endpoint is the proportion of participants with HIV-1 RNA < 50 copies/mL at week 24 using pure virologic response whilst the secondary efficacy endpoint is the proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48. Other secondary outcome measures include between arm comparisons of drug resistance at virological failure, safety and tolerability and patient-reported outcome measures.
DISCUSSION


We aim to provide preliminary evidence of the efficacy of switching to B/F/TAF in patients with virological suppression on a bPI-based regimen who harbour select drug resistance mutations.
TRIAL REGISTRATION


ISRCTN 44453201 , registered 19 June 2019 and EudraCT 2018-004732-30.",2020,The primary efficacy endpoint is the proportion of participants with HIV-1 RNA < 50 copies/mL at week 24 using pure virologic response whilst the secondary efficacy endpoint is the proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48.,"['Integrase inhibitor-naïve, virologically suppressed HIV-1 infected adults harbouring drug resistance mutations (PIBIK study', 'patients with virological suppression on a bPI-based regimen who harbour select drug resistance mutations', 'integrase inhibitor-naïve, virologically suppressed adults with HIV-1 infection harbouring drug resistance mutations', '44453201 , registered 19 June 2019 and EudraCT 2018-004732-30', 'Eligible individuals will either continue on their bPI regimen or switch to B/F/TAF FDC']","['Bictegravir/Emtricitabine/Tenofovir Alafenamide single tablet regimen', 'switching to B/F/TAF']","['safety and efficacy', 'drug resistance at virological failure, safety and tolerability and patient-reported outcome measures', 'proportion of participants with HIV-1 RNA']","[{'cui': 'C0376601', 'cui_str': 'Integrase strand transfer inhibitor-containing product'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0013203', 'cui_str': 'Drug resistance'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1450557', 'cui_str': 'IGFBP7 protein, human'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C4542162', 'cui_str': 'emtricitabine, tenofovir alafenamide and bictegravir'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1450557', 'cui_str': 'IGFBP7 protein, human'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013203', 'cui_str': 'Drug resistance'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}]",,0.162955,The primary efficacy endpoint is the proportion of participants with HIV-1 RNA < 50 copies/mL at week 24 using pure virologic response whilst the secondary efficacy endpoint is the proportion of participants with HIV-1 RNA < 50 copies/mL at Week 48.,"[{'ForeName': 'Collins C', 'Initials': 'CC', 'LastName': 'Iwuji', 'Affiliation': 'Department of Global Health and Infection, Brighton and Sussex Medical School, University of Sussex, Falmer, Brighton, BN1 9PX, UK. c.iwuji@bsms.ac.uk.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Churchill', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Bremner', 'Affiliation': 'Department of Primary Care and Public Health, Brighton and Sussex Medical School, University of Sussex, Brighton, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Perry', 'Affiliation': 'Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'To', 'Affiliation': 'Brighton & Sussex Clinical Trials Unit, University of Sussex, Brighton, UK.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Lambert', 'Affiliation': 'Brighton & Sussex Clinical Trials Unit, University of Sussex, Brighton, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Bruce', 'Affiliation': 'Brighton & Sussex Clinical Trials Unit, University of Sussex, Brighton, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Waters', 'Affiliation': 'The Mortimer Market Centre, Central and North West London NHS Foundation Trust, London, UK.'}, {'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Orkin', 'Affiliation': 'Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Geretti', 'Affiliation': 'Institute of Infection, University of Liverpool, Liverpool, UK.'}]",BMC infectious diseases,['10.1186/s12879-020-05240-y']
1643,32691513,Benefit/risk profile of dapagliflozin 5 mg in the DEPICT-1 and -2 trials in individuals with type 1 diabetes and body mass index ≥27 kg/m 2 .,"AIM


The DEPICT-1 and -2 studies (NCT02268214, NCT02460978) evaluated the efficacy and safety of dapagliflozin in individuals with type 1 diabetes who were receiving intensive insulin therapy. The DEPICT-1 and -2 studies (NCT02268214, NCT02460978) evaluated the efficacy and safety of dapagliflozin in individuals with type 1 diabetes. This post-hoc study investigated the safety and efficacy of dapagliflozin in individuals with BMI ≥27 kg/m 2  to assess if the benefit:risk ratio associated with dapagliflozin treatment can be further improved than that observed in the overall DEPICT population.
METHODS


Changes in glycated haemoglobin (HbA1c) and body weight, percentage change in daily insulin dose and proportion of participants achieving HbA1c reduction ≥0.5% without severe hypoglycaemia were evaluated at weeks 24 and 52. Changes in mean interstitial glucose, mean amplitude of glycaemic excursions and time in target glycaemic range were evaluated at week 24. Safety was assessed until week 56.
RESULTS


Week-52 adjusted mean (SE) change from baseline for HbA1c was -0.26% (0.05) with dapagliflozin versus +0.08% (0.05) with placebo and for body weight was -2.74 kg (0.25) with dapagliflozin versus +0.81 kg (0.26) with placebo. Mean (SE) percentage change in daily insulin dose was -10.5% (1.23) with dapagliflozin versus -1.4% (1.36) with placebo. Time spent in target glycaemic range increased by 2.2 h/day versus placebo. Dapagliflozin was well tolerated, with fewer participants experiencing diabetic ketoacidosis (dapagliflozin, 1.7%; placebo, 1.0%) than dapagliflozin 5 mg receiving participants in the pooled DEPICT populations.
CONCLUSIONS


Compared with the pooled DEPICT population, the benefit/risk profile of adjunct dapagliflozin therapy was more favourable in individuals with type 1 diabetes with body mass index ≥27 kg/m 2  because of the reduced risk of diabetic ketoacidosis in this population.",2020,Week-52 adjusted mean (SE) change from baseline for HbA1c was -0.26% (0.05) with dapagliflozin versus +0.08% (0.05) with placebo and for body weight was -2.74,"['Individuals with Type 1 Diabetes and BMI ≥27 kg/m 2 ', 'individuals with BMI ≥27 kg/m 2  ', 'individuals with type 1 diabetes who were receiving intensive insulin therapy']","['dapagliflozin therapy', 'Dapagliflozin', 'dapagliflozin', 'placebo']","['Safety', 'tolerated', 'Time spent in target glycaemic range', 'Mean [SE] percent change in daily insulin dose', 'diabetic ketoacidosis', 'efficacy and safety', 'safety and efficacy', 'mean interstitial glucose, mean amplitude of glycaemic excursions, and time in target glycaemic range', 'HbA1c and body weight, percent change in daily insulin dose and proportion of participants achieving HbA1c reduction ≥0.5% without severe hypoglycaemia']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1522203', 'cui_str': 'Interstitial route'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}]",,0.178292,Week-52 adjusted mean (SE) change from baseline for HbA1c was -0.26% (0.05) with dapagliflozin versus +0.08% (0.05) with placebo and for body weight was -2.74,"[{'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Clinical and Experimental Endocrinology, UZ Gasthuisberg, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Paresh', 'Initials': 'P', 'LastName': 'Dandona', 'Affiliation': 'State University of New York at Buffalo, Williamsville, New York, USA.'}, {'ForeName': 'Andreas L', 'Initials': 'AL', 'LastName': 'Birkenfeld', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Centre Munich, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Troels Krarup', 'Initials': 'TK', 'LastName': 'Hansen', 'Affiliation': 'Steno Diabetes Center Aarhus, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'Late-stage Development Cardiovascular, Renal and Metabolism, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Late-stage Development Cardiovascular, Renal and Metabolism, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Repetto', 'Affiliation': 'Global Medical Affairs, AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Markus Florian', 'Initials': 'MF', 'LastName': 'Scheerer', 'Affiliation': 'Diabetes Medical Department, AstraZeneca, Wedel, Germany.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Thoren', 'Affiliation': 'Late-stage Development Cardiovascular, Renal and Metabolism, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Phillip', 'Affiliation': ""Schneider Children's Medical Center of Israel, Petah Tikva, Israel.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14144']
1644,32692701,Could Anise decrease the intensity of premenstrual syndrome symptoms in comparison to placebo? A double-blind randomized clinical trial.,"Background Premenstrual syndrome (PMS) has a high prevalence among women of reproductive ages but despite its high prevalence, it has no determined and absolute treatment, so far. So, the aim of the present study was to compare the effect Pimpinella Anisum (Anise) with placebo on the intensity of the symptoms of PMS. Methods The present study was a randomized double-blind controlled clinical trial. College students who were suffering from PMS and had the inclusion criteria were selected and randomly assigned into two groups of intervention (Anise) and control (placebo). Participants in the intervention group, received 110 mg capsules of Anise three times day (a total dose of 330 mg per day); the control group received similar capsules with the same dosing that contained starch. Consumption of the capsules was started 7 days before the start of the menstruation and continued until 3 days after, which was a total of 10 days during two consecutive menstruation cycles. The intensity of the symptoms of premenstrual syndrome was measured using Premenstrual Symptoms Screening Tool (PSST). To compare the intensity of the symptoms between the two study groups, generalized estimating equation statistical method was used. Results Eventually, sixty-seven 18-35 year old college students who were suffering from premenstrual syndrome were enrolled in the study. Comparing the mean score of the intensity of the syndrome between the two groups after the first and the second menstruation cycles showed a decrease in the intervention group to 13.9 (p-value<0.001; 95% CI: 16.5,-11.4) and 9.8 (p-value<0.001; 95% CI: 12.4,-7.3), respectively. Conclusion Results of the study showed that, in general, Anise was effective in decreasing the symptoms of premenstrual syndrome in comparison to placebo.",2020,"Comparing the mean score of the intensity of the syndrome between the two groups after the first and the second menstruation cycles showed a decrease in the intervention group to 13.9 (p-value<0.001; 95% CI: 16.5,-11.4) and 9.8 (p-value<0.001; 95% CI: 12.4,-7.3), respectively.","['Eventually, sixty-seven 18-35\u2006year old college students who were suffering from premenstrual syndrome were enrolled in the study', 'College students who were suffering from PMS and had the inclusion criteria']","['control group received similar capsules with the same dosing that contained starch', 'intervention (Anise) and control (placebo', 'placebo']","['mean score of the intensity of the syndrome', 'symptoms of premenstrual syndrome', 'intensity of premenstrual syndrome symptoms', 'intensity of the symptoms of premenstrual syndrome']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1857276', 'cui_str': 'Trichohepatoenteric syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033046', 'cui_str': 'Premenstrual syndrome'}]",,0.376752,"Comparing the mean score of the intensity of the syndrome between the two groups after the first and the second menstruation cycles showed a decrease in the intervention group to 13.9 (p-value<0.001; 95% CI: 16.5,-11.4) and 9.8 (p-value<0.001; 95% CI: 12.4,-7.3), respectively.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Farahmand', 'Affiliation': 'Research Institute for Endocrine Sciences, Reproductive Endocrinology Research Center, Shahid Beheshti University of Medical Sciences Tehran, Iran (Islamic Republic of).'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Khalili', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fahimeh', 'Initials': 'F', 'LastName': 'Ramezani Tehrani', 'Affiliation': 'Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Gholamreza', 'Initials': 'G', 'LastName': 'Amin', 'Affiliation': 'Department of Pharmacognosy, faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Negarandeh', 'Affiliation': 'Nursing & Midwifery Care Research Center, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0077']
1645,32700188,"Long-Term Cost-Effectiveness Analyses of Empagliflozin Versus Oral Semaglutide, in Addition to Metformin, for the Treatment of Type 2 Diabetes in the UK.","INTRODUCTION


International guidelines recommend treatment with a sodium-glucose cotransporter-2 (SGLT-2) inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonist for treatment intensification in type 2 diabetes mellitus (T2DM) patients with progression on metformin. In the randomised, controlled, Peptide Innovation for Early Diabetes Treatment (PIONEER) 2 trial, the SGLT-2 inhibitor empagliflozin was compared with the GLP-1 receptor agonist oral semaglutide, in addition to metformin. The aim of the current study was to assess the long-term cost-effectiveness of empagliflozin 25 mg versus oral semaglutide 14 mg, in addition to metformin, for T2DM patients in the UK.
METHODS


Analyses were conducted from the UK healthcare payer perspective, using the IQVIA Core Diabetes model, with a time horizon of 50 years. Patients received either empagliflozin or oral semaglutide, in addition to metformin, until Hba1c threshold of 7.5% (58 mmol/mol) was exceeded, following which treatment intensification with insulin glargine in addition to empagliflozin or oral semaglutide plus metformin was assumed. Baseline cohort characteristics and 52-week treatment effects were derived from the PIONEER 2 trial. Treatment effects of empagliflozin and GLP-1 receptor agonists on hospitalisation for heart failure (hHF) were based on the Empagliflozin Comparative Effectiveness and Safety (EMPRISE) real-world study. Utilities, treatment costs and costs of diabetes-related complications were obtained from published sources.
RESULTS


Direct costs for empagliflozin plus metformin were considerably lower than those for oral semaglutide plus metformin (by more than GBP 6000). Compared with oral semaglutide plus metformin, empagliflozin plus metformin was a cost-effective treatment for T2DM patients in all scenarios tested. Probabilistic sensitivity analysis showed cost-effectiveness in > 95% of the iterations using a threshold of 20,000 GBP/QALY.
CONCLUSION


Empagliflozin 25 mg is a cost-effective treatment option versus oral semaglutide 14 mg, when used in addition to metformin, for the treatment of T2DM patients in the UK.",2020,"Probabilistic sensitivity analysis showed cost-effectiveness in > 95% of the iterations using a threshold of 20,000 GBP/QALY.
","['type 2 diabetes mellitus (T2DM) patients with progression on', 'T2DM patients in the UK', 'Early Diabetes Treatment (PIONEER', 'Analyses were conducted from the UK healthcare payer perspective, using the IQVIA Core Diabetes model, with a time horizon of 50\xa0years', 'Type 2 Diabetes in the UK']","['oral semaglutide plus metformin, empagliflozin plus metformin', 'Metformin', 'empagliflozin', 'SGLT-2 inhibitor empagliflozin', 'Empagliflozin Versus Oral Semaglutide', 'metformin', 'insulin glargine in addition to empagliflozin or oral semaglutide plus metformin', 'empagliflozin and GLP-1 receptor agonists', 'Empagliflozin', 'oral semaglutide plus metformin', 'empagliflozin plus metformin', 'sodium-glucose cotransporter-2\xa0(SGLT-2) inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonist', 'empagliflozin or oral semaglutide, in addition to metformin']","['cost-effectiveness', 'hospitalisation for heart failure (hHF', 'Utilities, treatment costs and costs of diabetes-related complications']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2348942', 'cui_str': 'Healthcare payer'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C2987634', 'cui_str': 'Receptor agonist'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0342257', 'cui_str': 'Diabetic complication'}]",,0.0229317,"Probabilistic sensitivity analysis showed cost-effectiveness in > 95% of the iterations using a threshold of 20,000 GBP/QALY.
","[{'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Ramos', 'Affiliation': 'Global HEOR/Real World Solutions, IQVIA, 2740-266, Porto Salvo, Portugal.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Cummings', 'Affiliation': 'Academic Department of Diabetes and Endocrinology, Queen Alexandra Hospital, Portsmouth, PO6 3LY, Hampshire, UK.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Ustyugova', 'Affiliation': 'Boehringer Ingelheim International GmbH, 55216, Ingelheim Am Rhein, Germany.'}, {'ForeName': 'Syed I', 'Initials': 'SI', 'LastName': 'Raza', 'Affiliation': 'Boehringer Ingelheim Ltd., Bracknell, RG12 8YS, Berkshire, UK.'}, {'ForeName': 'Shamika U', 'Initials': 'SU', 'LastName': 'de Silva', 'Affiliation': 'Boehringer Ingelheim Ltd., Bracknell, RG12 8YS, Berkshire, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lamotte', 'Affiliation': 'Global HEOR/Real World Solutions, IQVIA, 1930, Zaventem, Belgium. Mark.lamotte@iqvia.com.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00883-1']
1646,32697879,"Bi-hemispheric transcranial direct current stimulation for upper-limb hemiparesis in acute stroke: a randomized, double-blind, sham-controlled trial.","BACKGROUND AND PURPOSE


Neuromodulation is a promising approach to increasing motor recovery in stroke; however, to date, there is a scarcity of evidence documenting the clinical potential of transcranial direct current stimulation (tDCS) administered in the acute phase of stroke. The present study aims to examine the clinical effects of a treatment involving the application of tDCS in the acute stage post-stroke.
METHODS


This was a randomized, double-blind, sham-controlled trial. A cohort of 32 stroke patients with severe motor impairment underwent 5 days of treatment with real or sham bi-hemispheric tDCS over the motor cortex. During the treatment, tDCS was applied twice per day (two daily applications each of 15 min), starting 48 to 72 h after stroke onset.
RESULTS


We found statistically significant improvements after both real and sham tDCS treatments in primary (hand grip strength, Motricity Index) and secondary (National Institutes of Health Stroke Scale score, Barthel Index) outcomes. Patients receiving real tDCS showed a larger improvement of upper-limb muscle strength at the end of treatment phase; this advantage was no longer present after 6 months.
CONCLUSIONS


Transcranial direct current stimulation may be used to accelerate the rate of upper-limb motor recovery during the spontaneous recovery period.",2020,"We found statistically significant improvements after both real and sham tDCS treatments in primary (Hand Grip Strength, Motricity Index) and secondary (NIHSS, Barthel Index) outcomes.","['acute stroke', '32 stroke patients with severe motor impairment underwent a']","['real tDCS', 'tDCS', 'Bihemispheric tDCS', '5-days treatment with real or sham bi-hemispheric tDCS']","['upper-limb muscle strength', 'rate of upper-limb motor recovery', 'primary (Hand Grip Strength, Motricity Index) and secondary (NIHSS, Barthel Index) outcomes']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0451322', 'cui_str': 'Motricity index'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1697238', 'cui_str': 'NIH stroke scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.629061,"We found statistically significant improvements after both real and sham tDCS treatments in primary (Hand Grip Strength, Motricity Index) and secondary (NIHSS, Barthel Index) outcomes.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bolognini', 'Affiliation': 'Department of Psychology and Milan Center for Neuroscience (NeuroMi), University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Russo', 'Affiliation': 'Department of Psychology and Milan Center for Neuroscience (NeuroMi), University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Cairnero Souza', 'Affiliation': 'Department of Psychology and Milan Center for Neuroscience (NeuroMi), University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nicotra', 'Affiliation': 'Department of Psychology and Milan Center for Neuroscience (NeuroMi), University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Olgiati', 'Affiliation': 'Department of Psychology and Milan Center for Neuroscience (NeuroMi), University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Spandri', 'Affiliation': 'Department of Psychology and Milan Center for Neuroscience (NeuroMi), University of Milano-Bicocca, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Agostoni', 'Affiliation': ""Neurology and Stroke Unit, Department of Neurosciences, Niguarda Ca' Granda Hospital, Milan, Italy.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Salmaggi', 'Affiliation': 'Neurology - Stroke Unit, A. Manzoni Hospital, ASST Lecco, Lecco, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Vallar', 'Affiliation': 'Department of Psychology and Milan Center for Neuroscience (NeuroMi), University of Milano-Bicocca, Milan, Italy.'}]",European journal of neurology,['10.1111/ene.14451']
1647,32702468,Predicting post one-year durability of glucose-lowering monotherapies in patients with newly-diagnosed type 2 diabetes mellitus - A MASTERMIND precision medicine approach (UKPDS 87).,"AIMS


Predicting likely durability of glucose-lowering therapies for people with type 2 diabetes (T2D) could help inform individualised therapeutic choices.
METHODS


We used data from UKPDS patients with newly-diagnosed T2D randomised to first-line glucose-lowering monotherapy with chlorpropamide-glibenclamide-basal insulin or metformin. In 2339 participants who achieved one-year HbA 1c  values <7.5% (<59 mmol/mol)-we assessed relationships between one-year characteristics and time to monotherapy-failure (HbA 1c  ≥ 7.5% or requiring second-line therapy). Model validation was performed using bootstrap sampling.
RESULTS


Follow-up was median (IQR) 11.0 (8.0-14.0) years. Monotherapy-failure occurred in 72%-82%-75% and 79% for those randomised to chlorpropamide-glibenclamide-basal insulin or metformin respectively-after median 4.5 (3.0-6.6)-3.7 (2.6-5.6)-4.2 (2.7-6.5) and 3.8 (2.6- 5.2) years. Time-to-monotherapy-failure was predicted primarily by HbA 1c  and BMI values-with other risk factors varying by type of monotherapy-with predictions to within ±2.5 years for 55%-60%-56% and 57% of the chlorpropamide-glibenclamide-basal insulin and metformin monotherapy cohorts respectively.
CONCLUSIONS


Post one-year glycaemic durability can be predicted robustly in individuals with newly-diagnosed T2D who achieve HbA 1c values  < 7.5% one year after commencing traditional monotherapies. Such information could be used to help guide glycaemic management for individual patients.",2020,Monotherapy-failure occurred in 72%-82%-75% and 79% for those randomised to chlorpropamide-glibenclamide-basal insulin or metformin respectively-after median 4.5 (3.0-6.6)-3.7 (2.6-5.6)-4.2 (2.7-6.5) and 3.8 (2.6- 5.2) years.,"['2,339 participants who achieved one-year HbA 1c  values <7.5% (<59 mmol/mol)-we assessed relationships between one-year characteristics and time to monotherapy-failure (HbA 1c  ≥7.5% or requiring second-line therapy', 'people with type 2 diabetes ', 'Patients with Newly-diagnosed Type 2 Diabetes Mellitus', 'UKPDS patients with newly-diagnosed T2D randomised to first']","['chlorpropamide-glibenclamide-basal insulin or metformin', 'line glucose-lowering monotherapy with chlorpropamide-glibenclamide-basal insulin or metformin', 'glucose-lowering therapies', 'Glucose-lowering Monotherapies']","['Monotherapy-failure', 'Time-to-monotherapy-failure']","[{'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1710038', 'cui_str': 'Second line treatment'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0008287', 'cui_str': 'Chlorpropamide'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",2339.0,0.0533422,Monotherapy-failure occurred in 72%-82%-75% and 79% for those randomised to chlorpropamide-glibenclamide-basal insulin or metformin respectively-after median 4.5 (3.0-6.6)-3.7 (2.6-5.6)-4.2 (2.7-6.5) and 3.8 (2.6- 5.2) years.,"[{'ForeName': 'Olorunsola F', 'Initials': 'OF', 'LastName': 'Agbaje', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK. Electronic address: olorunsola.agbaje@dtu.ox.ac.uk.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hattersley', 'Affiliation': 'Institute of Biomedical & Clinical Science-University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Angus G', 'Initials': 'AG', 'LastName': 'Jones', 'Affiliation': 'Institute of Biomedical & Clinical Science-University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Ewan R', 'Initials': 'ER', 'LastName': 'Pearson', 'Affiliation': 'Medical Research Institute, University of Dundee, Dundee, UK.'}, {'ForeName': 'Beverley M', 'Initials': 'BM', 'LastName': 'Shields', 'Affiliation': 'Institute of Biomedical & Clinical Science-University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes research and clinical practice,['10.1016/j.diabres.2020.108333']
1648,32702522,Impact of couple conflict and mediation on how romantic partners are seen: An fMRI study.,"Previous studies on romantic love have reported increased neural activity in the brain's reward circuitry such as the striatum. To date, the extent to which this activity is modulated by couple conflict in general and mediated couple conflict in particular, is unknown. The present study seeks to fill this gap by randomly assigning 36 romantic heterosexual couples to a mediated or non-mediated conflict discussion. Before and after the conflict discussion, self-reports and functional neuroimaging data in response to a picture of the romantic partner versus an unknown person were acquired. Self-reports indicate that mediation increases conflict resolution, satisfaction about the contents and process of the discussion and decreases levels of remaining disagreement. Pre-conflict neuroimaging results replicate previous studies on romantic love, showing activations in the striatum, insula, anterior and posterior cingulate gyrus, orbitofrontal cortex, hippocampus, temporal and occipital poles and amygdala when viewing the romantic partner versus an unknown person. The general effect of conflict on neural activations in response to the romantic partner across both conditions consisted of deactivations in the striatum, insula, thalamus, precuneus and ventral tegmental area. Small volume correction analyses revealed that participants in the mediated condition trended towards having greater activation in the nucleus accumbens than participants in the non-mediated condition when looking at the romantic partner versus the unknown after the conflict discussion. Parametric modulation analyses also revealed greater activity in the nucleus accumbens when viewing the romantic partner versus the unknown for participants who felt more satisfied after the conflict resolution. Our results illustrate that mediation improves conflict resolution and is associated with increased activity in the nucleus accumbens, a key region in the brain's reward circuitry.",2020,Parametric modulation analyses also revealed greater activity in the nucleus accumbens when viewing the romantic partner versus the unknown for participants who felt more satisfied after the conflict resolution.,['36 romantic heterosexual couples to a mediated or non-mediated conflict discussion'],[],"['neural activity', 'conflict resolution']","[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]",[],"[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0150526', 'cui_str': 'Conflict Resolution'}]",36.0,0.0299096,Parametric modulation analyses also revealed greater activity in the nucleus accumbens when viewing the romantic partner versus the unknown for participants who felt more satisfied after the conflict resolution.,"[{'ForeName': 'Halima', 'Initials': 'H', 'LastName': 'Rafi', 'Affiliation': 'Swiss Center for Affective Sciences, University of Geneva, Geneva, Switzerland; Department of Psychology, University of Geneva, Geneva, Switzerland. Electronic address: Halima.Rafi@unige.ch.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Bogacz', 'Affiliation': 'Swiss Center for Affective Sciences, University of Geneva, Geneva, Switzerland; Computer Vision and Multimedia Laboratory, University of Geneva, Battelle Campus, Carouge, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sander', 'Affiliation': 'Swiss Center for Affective Sciences, University of Geneva, Geneva, Switzerland; Laboratory for the Study of Emotion Elicitation and Expression, Department of Psychology, University of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Klimecki', 'Affiliation': 'Swiss Center for Affective Sciences, University of Geneva, Geneva, Switzerland; Laboratory for the Study of Emotion Elicitation and Expression, Department of Psychology, University of Geneva, Geneva, Switzerland; Laboratory for Behavioral Neurology and Imaging of Cognition, Department of Neuroscience, Medical School, University of Geneva, Geneva, Switzerland. Electronic address: Olga.Klimecki@unige.ch.'}]",Cortex; a journal devoted to the study of the nervous system and behavior,['10.1016/j.cortex.2020.04.036']
1649,32701508,Effects of tesamorelin on hepatic transcriptomic signatures in HIV-associated NAFLD.,"Nonalcoholic fatty liver disease (NAFLD) is a common comorbidity among people living with HIV that has a more aggressive course than NAFLD among the general population. In a recent randomized placebo-controlled trial, we demonstrated that the growth hormone-releasing hormone analog tesamorelin reduced liver fat and prevented fibrosis progression in HIV-associated NAFLD over 1 year. As such, tesamorelin is the first strategy that has shown to be effective against NAFLD among the population with HIV. The current study leveraged paired liver biopsy specimens from this trial to identify hepatic gene pathways that are differentially modulated by tesamorelin versus placebo. Using gene set enrichment analysis, we found that tesamorelin increased hepatic expression of hallmark gene sets involved in oxidative phosphorylation and decreased hepatic expression of gene sets contributing to inflammation, tissue repair, and cell division. Tesamorelin also reciprocally up- and downregulated curated gene sets associated with favorable and poor hepatocellular carcinoma prognosis, respectively. Notably, among tesamorelin-treated participants, these changes in hepatic expression correlated with improved fibrosis-related gene score. Our findings inform our knowledge of the biology of pulsatile growth hormone action and provide a mechanistic basis for the observed clinical effects of tesamorelin on the liver.",2020,"Using Gene Set Enrichment Analysis (GSEA), we found that tesamorelin increased hepatic expression of hallmark gene sets involved in oxidative phosphorylation and decreased hepatic expression of gene sets contributing to inflammation, tissue repair, and cell division.","['HIV-associated NAFLD', 'people living with HIV with a more aggressive course than in the general population']","['growth hormone-releasing hormone analogue tesamorelin', 'tesamorelin', 'Nonalcoholic fatty liver disease (NAFLD', 'placebo']","['hepatic transcriptomic signatures', 'hepatic expression', 'liver fat and prevented fibrosis progression']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0037668', 'cui_str': 'Somatotropin releasing factor'}, {'cui': 'C1876200', 'cui_str': 'tesamorelin'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",,0.0417018,"Using Gene Set Enrichment Analysis (GSEA), we found that tesamorelin increased hepatic expression of hallmark gene sets involved in oxidative phosphorylation and decreased hepatic expression of gene sets contributing to inflammation, tissue repair, and cell division.","[{'ForeName': 'Lindsay T', 'Initials': 'LT', 'LastName': 'Fourman', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Billingsley', 'Affiliation': 'Harvard Chan Bioinformatics Core, Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Agyapong', 'Affiliation': 'Liver Center, Digestive Healthcare Center, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Shannan J', 'Initials': 'SJ', 'LastName': 'Ho Sui', 'Affiliation': 'Harvard Chan Bioinformatics Core, Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Meghan N', 'Initials': 'MN', 'LastName': 'Feldpausch', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Purdy', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Zheng', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Chelsea S', 'Initials': 'CS', 'LastName': 'Pan', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Corey', 'Affiliation': 'Liver Center, Digestive Healthcare Center, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Torriani', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kleiner', 'Affiliation': 'Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Hadigan', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, Maryland, USA.'}, {'ForeName': 'Takara L', 'Initials': 'TL', 'LastName': 'Stanley', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Raymond T', 'Initials': 'RT', 'LastName': 'Chung', 'Affiliation': 'Liver Center, Digestive Healthcare Center, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Grinspoon', 'Affiliation': 'Metabolism Unit, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}]",JCI insight,['10.1172/jci.insight.140134']
1650,32708743,Effect of a Nutritional Intervention on the Intestinal Microbiota of Vertically HIV-Infected Children: The Pediabiota Study.,"AIMS


The gut microbiota exerts a critical influence in the immune system. The gut microbiota of human virus immunodeficiency (HIV)-infected children remains barely explored. We aimed to characterize the fecal microbiota in vertically HIV-infected children and to explore the effects of its modulation with a symbiotic nutritional intervention.
METHODS


a pilot, double blind, randomized placebo-controlled study including HIV-infected children who were randomized to receive a nutritional supplementation including prebiotics and probiotics or placebo for four weeks. HIV-uninfected siblings were recruited as controls. The V3-V4 region of the 16S rRNA gene was sequenced in fecal samples.
RESULTS


22 HIV-infected children on antiretroviral therapy (ART) and with viral load (VL) <50/mL completed the follow-up period. Mean age was 11.4 ± 3.4 years, eight (32%) were male. Their microbiota showed reduced alpha diversity compared to controls and distinct beta diversity at the genus level (Adonis  p  = 0.042). Patients showed decreased abundance of commensals  Faecalibacterium  and an increase in  Prevotella, Akkermansia  and  Escherichia.  The nutritional intervention shaped the microbiota towards the control group, without a clear directionality.
CONCLUSIONS


Vertical HIV infection is characterized by changes in gut microbiota structure, distinct at the compositional level from the findings reported in adults. A short nutritional intervention attenuated bacterial dysbiosis, without clear changes at the community level.
SUMMARY


In a group of 24 vertically HIV-infected children, in comparison to 11 uninfected controls, intestinal dysbiosis was observed despite effective ART. Although not fully effective to restore the microbiota, a short intervention with pre/probiotics attenuated bacterial dysbiosis.",2020,Their microbiota showed reduced alpha diversity compared to controls and distinct beta diversity at the genus level,"['HIV-infected children', 'Vertically HIV-Infected Children', '22 HIV-infected children on antiretroviral therapy (ART) and with viral load (VL) <50/mL completed the follow-up period', 'vertically HIV-infected children', 'HIV-uninfected siblings', 'Mean age was 11.4 ± 3.4 years, eight (32%) were male']","['nutritional supplementation including prebiotics and probiotics or placebo', 'Nutritional Intervention', 'symbiotic nutritional intervention', 'placebo']","['abundance of commensals  Faecalibacterium  and an increase in  Prevotella, Akkermansia  and  Escherichia', 'fecal microbiota', 'alpha diversity']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0542329', 'cui_str': 'Commensal parasite'}, {'cui': 'C1229075', 'cui_str': 'Faecalibacterium'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0242946', 'cui_str': 'Prevotella'}, {'cui': 'C1490589', 'cui_str': 'Akkermansia'}, {'cui': 'C0014833', 'cui_str': 'Escherichia'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}]",,0.0511436,Their microbiota showed reduced alpha diversity compared to controls and distinct beta diversity at the genus level,"[{'ForeName': 'Talía', 'Initials': 'T', 'LastName': 'Sainz', 'Affiliation': 'Servicio de Pediatría, Hospital Universitario La Paz and IdiPAZ, 28046 Madrid, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Gosalbes', 'Affiliation': 'Área Genómica y Salud, Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO), 46010 Valencia, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Talavera-Rodríguez', 'Affiliation': 'Bioinformatics Unit, Hospital Universitario Ramón y Cajal and IRYCIS, 28034 Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Jimenez-Hernandez', 'Affiliation': 'Área Genómica y Salud, Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO), 46010 Valencia, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Prieto', 'Affiliation': 'Red de Investigación CoRISpe integrada en la Red en Infectología Pediátrica (RITIP), 28046 Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Escosa', 'Affiliation': 'Servicio de Pediatría, Hospital Universitario La Paz and IdiPAZ, 28046 Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Guillén', 'Affiliation': 'Red de Investigación CoRISpe integrada en la Red en Infectología Pediátrica (RITIP), 28046 Madrid, Spain.'}, {'ForeName': 'José Tomás', 'Initials': 'JT', 'LastName': 'Ramos', 'Affiliation': 'Red de Investigación CoRISpe integrada en la Red en Infectología Pediátrica (RITIP), 28046 Madrid, Spain.'}, {'ForeName': 'María Ángeles', 'Initials': 'MÁ', 'LastName': 'Muñoz-Fernández', 'Affiliation': 'Laboratorio InmunoBiología Molecular, Sección Inmunología, Hospital General Universitario Gregorio Marañón and Spanish HIV HGM BioBank, Madrid Spain, Networking Research Center on Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), 28007 Madrid, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Moya', 'Affiliation': 'Área Genómica y Salud, Fundación para el Fomento de la Investigación Sanitaria y Biomédica (FISABIO), 46010 Valencia, Spain.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Navarro', 'Affiliation': 'Red de Investigación CoRISpe integrada en la Red en Infectología Pediátrica (RITIP), 28046 Madrid, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Mellado', 'Affiliation': 'Servicio de Pediatría, Hospital Universitario La Paz and IdiPAZ, 28046 Madrid, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Serrano-Villar', 'Affiliation': 'Servicio de Enfermedades Infecciosas, Hospital Universitario Ramón y Cajal and IRYCIS, 28034 Madrid, Spain.'}]",Nutrients,['10.3390/nu12072112']
1651,32706698,A Dietary Mobile App for Patients Undergoing Hemodialysis: Prospective Pilot Study to Improve Dietary Intakes.,"BACKGROUND


Mobile technology has an impact on the health care sector, also within dietetics. Mobile health (mHealth) apps may be used for dietary assessment and self-monitoring, allowing for real-time reporting of food intakes. Changing eating behaviors is quite challenging, and patients undergoing hemodialysis, particularly, struggle to meet the target intakes set by dietary guidelines. Usage of mobile apps that are developed in a person-centered approach and in line with recommendations may support both patients and health care practitioners.
OBJECTIVE


This study is a pilot that aims at estimating the potential efficacy of a dietary intervention using a theory-based, person-centered smartphone app. Results will be used to improve both the app and a planned large-scale trial intended to assess app efficacy thoroughly.
METHODS


A prospective pilot study was performed at the hemodialysis unit of Al Qassimi Hospital (The Emirate of Sharjah). All patients that fulfilled the study inclusion criteria were considered eligible to be enrolled in the pilot study. Upon successful installation of the app, users met with a dietitian once a week. Outcomes were measured at baseline (T0) and 2 weeks post app usage (T1). This pilot is reported as per guidelines for nonrandomized pilot and feasibility studies and in line with the CONSORT 2010 checklist for reporting pilot or feasibility trials.
RESULTS


A total of 23 patients completed the pilot intervention. Mean energy intakes increased from 24.4 kcal/kg/day (SD 8.0) to 29.1 kcal/kg/day (SD 7.8) with a medium effect size (d=0.6, 95% CI 0.0-1.2). Mean protein intakes increased from 0.9 g/kg/day (SD 0.3) to 1.3 g/kg/day (SD 0.5) with a large effect size (d=1.0, 95% CI 0.4-1.6); mean intake of high biological value (%HBV) proteins also increased from 58.6% (SD 10.1) to 70.1% (SD 10.7) with a large effect size (d=1.1, 95% CI 0.5-1.7). Dietary intakes of minerals did not change, apart from sodium which decreased from a mean intake of 2218.8 mg/day (SD 631.6) to 1895.3 mg/day (SD 581.0) with a medium effect size (d=0.5, 95% CI 0.1-1.1). Mean serum phosphorus, potassium, and albumin levels did not change relevantly. Mean serum iron increased from 7.9 mg/dL (SD 2.8) to 11.5 mg/dL (SD 7.9) postintervention with a medium effect size (d=0.6, 95% CI 0.0-1.2).
CONCLUSIONS


This pilot study showed that the KELA.AE app has the potential to improve dietary intakes. Processes related to procedure, resources, tools, and app improvement for a future trial were assessed. A more extended intervention using a randomized controlled trial is required to estimate parameters concerning app efficacy accurately.",2020,"Mean protein intakes increased from 0.9 g/kg/day (SD 0.3) to 1.3 g/kg/day (SD 0.5) with a large effect size (d=1.0, 95% CI 0.4-1.6); mean intake of high biological value (%HBV) proteins also increased from 58.6% (SD 10.1) to 70.1% (SD 10.7) with a large effect size (d=1.1, 95% CI 0.5-1.7).","['All patients that fulfilled the study inclusion criteria were considered eligible to be enrolled in the pilot study', 'Patients Undergoing Hemodialysis', 'hemodialysis unit of Al Qassimi Hospital', '23 patients completed the pilot intervention']","['KELA.AE', 'dietary intervention']","['Mean protein intakes', 'Mean serum iron', 'mean intake of high biological value', 'Mean serum phosphorus, potassium, and albumin levels', 'Mean energy intakes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0019005', 'cui_str': 'Hemodialysis machine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",23.0,0.105351,"Mean protein intakes increased from 0.9 g/kg/day (SD 0.3) to 1.3 g/kg/day (SD 0.5) with a large effect size (d=1.0, 95% CI 0.4-1.6); mean intake of high biological value (%HBV) proteins also increased from 58.6% (SD 10.1) to 70.1% (SD 10.7) with a large effect size (d=1.1, 95% CI 0.5-1.7).","[{'ForeName': 'Cosette', 'Initials': 'C', 'LastName': 'Fakih El Khoury', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Rik', 'Initials': 'R', 'LastName': 'Crutzen', 'Affiliation': 'Department of Health Promotion, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Jos M G A', 'Initials': 'JMGA', 'LastName': 'Schols', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Ruud J G', 'Initials': 'RJG', 'LastName': 'Halfens', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Mirey', 'Initials': 'M', 'LastName': 'Karavetian', 'Affiliation': 'Department of Health Sciences, Zayed University, Dubai, United Arab Emirates.'}]",Journal of medical Internet research,['10.2196/17817']
1652,32706704,Features of a Patient Portal for Blood Test Results and Patient Health Engagement: Web-Based Pre-Post Experiment.,"BACKGROUND


The use of patient portals for presenting health-related patient data, such as blood test results, is becoming increasingly important in health practices. Patient portals have the potential to enhance patient health engagement, but content might be misinterpreted.
OBJECTIVE


This study aimed to discover whether the way of presenting blood test outcomes in an electronic patient portal is associated with patient health engagement and whether this varies across different blood test outcomes.
METHODS


A 2x3 between-subjects experiment was conducted among members of the Nivel Dutch Health Care Consumer Panel. All participants read a scenario in which they were asked to imagine themselves receiving blood test results. These results differed in terms of the presented blood values (ie, normal vs partially abnormal vs all abnormal) as well as in terms of whether the results were accompanied with explanatory text and visualization. Patient health engagement was measured both before (T0) and after (T1) participants were exposed to their fictive blood test results.
RESULTS


A total 487 of 900 invited members responded (response rate 54%), of whom 50.3% (245/487) were female. The average age of the participants was 52.82 years (SD 15.41 years). Patient health engagement saw either a significant decrease or a nonsignificant difference in the experimental groups after viewing the blood test results. The mean difference was smaller in the groups that received blood test results with additional text and visualization (mean T0  5.33, SE 0.08; mean T1  5.14, SE 0.09; mean difference 0.19, SE 0.08, P=.02) compared with groups that received blood test results without explanatory text and visualization (mean T0  5.19, SE 0.08; mean T1  4.55, SE 0.09; mean difference 0.64, SE 0.08, P<.001). Adding text and visualization, in particular, reduced the decline in patient health engagement in participants who received normal results or mixed results (ie, combination of normal and abnormal results).
CONCLUSIONS


Adding text and visualization features can attenuate the decrease in patient health engagement in participants who receive outcomes of a blood test via a patient portal, particularly when blood test results are (partly) normal. This suggests that explanatory text and visualization can be reassuring. Future research is warranted to determine whether these results can be generalized to a patient population who receive their actual blood test results.",2020,"Adding text and visualization, in particular, reduced the decline in patient health engagement in participants who received normal results or mixed results (ie, combination of normal and abnormal results).
","['participants who received normal results or mixed results (ie, combination of normal and abnormal results', 'The average age of the participants was 52.82 years (SD 15.41 years', 'A total 487 of 900 invited members responded (response rate 54%), of whom 50.3% (245/487) were female', 'A 2x3 between-subjects experiment was conducted among members of the Nivel Dutch Health Care Consumer Panel']",[],"['blood values', 'Patient health engagement', 'patient health engagement']","[{'cui': 'C0459422', 'cui_str': 'Normal result'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0459424', 'cui_str': 'Abnormal result'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0665509', 'cui_str': 'OF 900'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]",[],"[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",900.0,0.0704985,"Adding text and visualization, in particular, reduced the decline in patient health engagement in participants who received normal results or mixed results (ie, combination of normal and abnormal results).
","[{'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Struikman', 'Affiliation': 'Nivel (Netherlands Institute for Health Services Research), Utrecht, Netherlands.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Bol', 'Affiliation': 'Department of Communication and Cognition, Tilburg School of Humanities and Digital Sciences, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Annelijn', 'Initials': 'A', 'LastName': 'Goedhart', 'Affiliation': 'Saltro, Diagnostics Center for Health Care, Utrecht, Netherlands.'}, {'ForeName': 'Julia C M', 'Initials': 'JCM', 'LastName': 'van Weert', 'Affiliation': 'Department of Communication Science, Amsterdam School of Communication Research, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Talboom-Kamp', 'Affiliation': 'Saltro, Diagnostics Center for Health Care, Utrecht, Netherlands.'}, {'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'van Delft', 'Affiliation': 'Saltro, Diagnostics Center for Health Care, Utrecht, Netherlands.'}, {'ForeName': 'Anne E M', 'Initials': 'AEM', 'LastName': 'Brabers', 'Affiliation': 'Nivel (Netherlands Institute for Health Services Research), Utrecht, Netherlands.'}, {'ForeName': 'Liset', 'Initials': 'L', 'LastName': 'van Dijk', 'Affiliation': 'Nivel (Netherlands Institute for Health Services Research), Utrecht, Netherlands.'}]",Journal of medical Internet research,['10.2196/15798']
1653,32707101,The Family Check-Up 4 Health: Study protocol of a randomized type II hybrid effectiveness-implementation trial in integrated primary care (the healthy communities 4 healthy students study).,"BACKGROUND


Parenting interventions like the Family Check-Up have demonstrated effects on child physical and behavioral health outcomes. However, access to these programs is limited, particularly for populations experiencing health disparities. Primary care settings have become recognized as a potential delivery system in which these programs may be implemented at scale. The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
METHODS


We will conduct a hybrid type 2 effectiveness-implementation trial in partnership with a primary care clinic in a low-income, majority Latino community. Families with 2- to 5-year-old children will be eligible to participate. Families will be randomized to receive the intervention (n = 130) or services as usual (n = 70) and will be assessed annually over three years. Outcomes are informed by the RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, and maintenance). Effectiveness outcomes include child health behaviors (e.g., Dietary Screener Questionnaire), behavioral health (e.g., Strengths and Difficulties Questionnaire), and parenting (e.g., Proactive Parenting). Early stage implementation outcomes are also included (e.g., cost, acceptability, appropriateness, and feasibility). Effectiveness outcomes will be assessed via intent-to-treat (ITT) analyses. Implementation outcomes will be primarily descriptive with comparisons to prior trials of FCU4Health and the original FCU.
PROJECTED OUTCOMES


This trial will provide evidence related to the potential of integrated primary care settings to deliver evidence-based preventive interventions with a dual focus on behavioral and physical health.",2020,"The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
","['partnership with a primary care clinic in a low-income, majority Latino community', 'Families with 2- to 5-year-old children', 'integrated primary care (the healthy communities 4 healthy students study']",['Family Check-Up 4 Health (FCU4Health) program'],"['RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, and maintenance', 'cost, acceptability, appropriateness, and feasibility', 'child health behaviors (e.g., Dietary Screener Questionnaire), behavioral health (e.g., Strengths and Difficulties Questionnaire), and parenting (e.g., Proactive Parenting']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0420160', 'cui_str': 'History and physical examination, school'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]",,0.0514529,"The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
","[{'ForeName': 'Cady', 'Initials': 'C', 'LastName': 'Berkel', 'Affiliation': ""REACH Institute, Arizona State University, Tempe, AZ, USA; Phoenix Children's Hospital, Phoenix, AZ, USA. Electronic address: Cady.Berkel@asu.edu.""}, {'ForeName': 'Justin D', 'Initials': 'JD', 'LastName': 'Smith', 'Affiliation': 'Center for Prevention Implementation Methodology (Ce-PIM), Department of Psychiatry and Behavioral Sciences, Department of Preventive Medicine, Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Meg M', 'Initials': 'MM', 'LastName': 'Bruening', 'Affiliation': 'Department of Nutrition, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Jordan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Fu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Mauricio', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Grimm', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Winslow', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Ray', 'Affiliation': 'Bayless Integrated Healthcare, Phoenix, AZ, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Bourne', 'Affiliation': 'Southwest Maricopa Regional Council, First Things First, Peoria, AZ, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Dishion', 'Affiliation': 'REACH Institute, Arizona State University, Tempe, AZ, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106088']
1654,32707159,Obesity blunts cephalic-phase microvascular responses to food.,"Neurally mediated anticipatory responses, also named cephalic-phase responses, and microcirculatory regulation are two important mechanisms to maintain metabolic homeostasis. Altered cephalic-phase responses in obesity and its metabolic consequences have been proposed. There is, however, a lack of studies focusing on in vivo assessment of the microcirculation during this phase in patients with obesity. In this randomized controlled trial, we selected patients with obesity and healthy subjects after clinical and laboratory assessments. Those with obesity were randomized into two groups: experimental (cephalic-phase microvascular response stimulation - CP group, n = 13) and controls (n = 14). Healthy subjects (n = 17) were also included to form a CP control group. Skin microvascular assessment was used as a model of systemic microcirculation. Resting functional capillary density (FCD) and peak FCD during post-occlusive reactive hyperemia (PORH) were measured by dorsal finger videocapillaroscopy and expressed mainly capillary recruitment capacity. Resting red blood cell velocity (RBCV), peak RBCV during PORH (RBCV max ), and time taken to reach RBCV max  (TRBCV max ) were assessed by dynamic nailfold videocapillaroscopy and expressed the microhemodynamics. Patients with obesity (with or without stimulus) failed to show an increase on FCD during PORH post-stimulus (p = 0.221 and p = 0.307, respectively) depicting lack of capillary recruitment. In contrast, healthy subjects presented an increase in this microvascular outcome (p = 0.004). Changes in all variables of microhemodynamics occurred in both CP groups (healthy and those with obesity). During CP, we originally demonstrated an absence of capillary recruitment in subjects with obesity. These findings might contribute to the literature of microvascular impairment and metabolic conditions.",2020,"Patients with obesity (with or without stimulus) failed to show an increase on FCD during PORH post-stimulus (p=0.221 and p=0.307, respectively) depicting lack of capillary recruitment.","['healthy subjects', 'Patients with obesity (with or without stimulus', 'group, n=13) and controls (n=14', 'patients with obesity', 'Healthy subjects (n=17) were also included to form a CP control group', 'subjects with obesity', 'patients with obesity and healthy subjects after clinical and laboratory assessments']",['experimental (cephalic-phase microvascular response stimulation - CP'],"['Resting red blood cell velocity (RBCV), peak RBCV during PORH (RBCV max ), and time taken to reach RBCV max  (TRBCV max ', 'microvascular outcome', 'Skin microvascular assessment', 'FCD during PORH post-stimulus', 'Resting functional capillary density (FCD) and peak FCD during post-occlusive reactive hyperemia (PORH']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0205096', 'cui_str': 'Cephalic'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1562113', 'cui_str': 'Fleck corneal dystrophy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0006901', 'cui_str': 'Structure of capillary blood vessel (organ)'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}]",17.0,0.0160267,"Patients with obesity (with or without stimulus) failed to show an increase on FCD during PORH post-stimulus (p=0.221 and p=0.307, respectively) depicting lack of capillary recruitment.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Buss', 'Affiliation': 'Department of Nutrition Federal University of Health Sciences of Porto Alegre (UFCSPA), RS, Brazil; Graduate Program in Health Sciences, UFCSPA, RS, Brazil. Electronic address: carolinebuss@ufcspa.edu.br.'}, {'ForeName': 'Priscila A', 'Initials': 'PA', 'LastName': 'Maranhão', 'Affiliation': 'Clinical and Experimental Research Laboratory on Vascular Biology (BioVasc) Biomedical Center, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil; Faculty of Medicine, Center for Research in Health Technologies and Information Systems (CINTESIS), University of Porto, Porto, Portugal.'}, {'ForeName': 'Maria das Graças C', 'Initials': 'MDGC', 'LastName': 'de Souza', 'Affiliation': 'Clinical and Experimental Research Laboratory on Vascular Biology (BioVasc) Biomedical Center, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Eliete', 'Initials': 'E', 'LastName': 'Bouskela', 'Affiliation': 'Clinical and Experimental Research Laboratory on Vascular Biology (BioVasc) Biomedical Center, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Luiz Guilherme', 'Initials': 'LG', 'LastName': 'Kraemer-Aguiar', 'Affiliation': 'Clinical and Experimental Research Laboratory on Vascular Biology (BioVasc) Biomedical Center, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil; Department of Internal Medicine Faculty of Medical Sciences, State University of Rio de Janeiro, Rio de Janeiro, RJ, Brazil.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113087']
1655,32729763,The effects of moderate alterations in adrenergic activity on acute appetite regulation in obese women: A randomised crossover trial.,"BACKGROUND


Previous evidence has demonstrated that serum leptin is correlated with appetite in combination with, but not without, modest exercise.
AIM


The present experiments investigated the effects of exogenous adrenaline and α/β adrenoceptor blockade in combination with moderate exercise on serum leptin concentrations, appetite/satiety sensations and subsequent food intake in obese women.
METHODS


A total of 10 obese women ((mean ± SEM), age: 50 (1.9) years, body mass index 36 (4.1) kg/m 2 , waist 104.8 (4.1) cm) participated in two separate, double-blind randomised experimental trials. Experiment 1: moderate exercise after α/β adrenergic blocker (labetalol, 100 mg orally) versus moderate exercise plus placebo; experiment 2: adrenaline infusion for 20 minutes versus saline infusion. Appetite/satiety and biochemistry were measured at baseline, pre- and immediately post-intervention, then 1 hour post-intervention (i.e., before dinner). Food intake was assessed via ad libitum buffet-style dinner.
RESULTS


No differences were found in appetite/satiety, subsequent food intake or serum leptin in any of the studies (experiment 1 or experiment 2). In experiment 1, blood glucose was higher ( p  < 0.01) and plasma free fatty acids lower ( p  = 0.04) versus placebo. In experiment 2, plasma free fatty acids ( p  < 0.05) increased after adrenaline versus saline infusion.
CONCLUSIONS


Neither inhibition of exercise-induced adrenergic activity by combined α/β adrenergic blockade nor moderate increases in adrenergic activity induced by intravenous adrenaline infusion affected acute appetite regulation.",2020,"No differences were found in appetite/satiety, subsequent food intake or serum leptin in any of the studies (experiment 1 or experiment 2).","['10 obese women ((mean ± SEM), age: 50 (1.9) years, body mass index 36 (4.1) kg/m 2 , waist 104.8 (4.1) cm', 'obese women']","['adrenaline infusion', 'moderate exercise after α/β adrenergic blocker (labetalol, 100 mg orally) versus moderate exercise plus placebo', 'exogenous adrenaline and α/β adrenoceptor blockade', 'adrenaline', 'placebo']","['Appetite/satiety and biochemistry', 'blood glucose', 'plasma free fatty acids lower', 'plasma free fatty acids', 'Food intake', 'appetite/satiety, subsequent food intake or serum leptin', 'serum leptin concentrations, appetite/satiety sensations and subsequent food intake', 'adrenergic activity']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0262878', 'cui_str': 'Scanning electron microscope'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242889', 'cui_str': 'Substance with adrenergic receptor antagonist mechanism of action'}, {'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",10.0,0.382086,"No differences were found in appetite/satiety, subsequent food intake or serum leptin in any of the studies (experiment 1 or experiment 2).","[{'ForeName': 'Fotini', 'Initials': 'F', 'LastName': 'Tsofliou', 'Affiliation': 'Human Nutrition, School of Medicine, University of Glasgow, United Kingdom.'}, {'ForeName': 'Yannis P', 'Initials': 'YP', 'LastName': 'Pitsiladis', 'Affiliation': 'College of Medical Veterinary and Life Science, Institute of Cardiovascular & Medical Sciences, University of Glasgow, United Kingdom.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lara', 'Affiliation': 'Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University, United Kingdom.'}, {'ForeName': 'Marios', 'Initials': 'M', 'LastName': 'Hadjicharalambous', 'Affiliation': 'College of Medical Veterinary and Life Science, Institute of Cardiovascular & Medical Sciences, University of Glasgow, United Kingdom.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'Macdonald', 'Affiliation': ""School of Life Sciences, University of Nottingham Medical School, Queen's Medical Centre, United Kingdom.""}, {'ForeName': 'Mike A', 'Initials': 'MA', 'LastName': 'Wallace', 'Affiliation': 'University Department of Pathological Biochemistry, Glasgow Royal Infirmary, United Kingdom.'}, {'ForeName': 'Mike E J', 'Initials': 'MEJ', 'LastName': 'Lean', 'Affiliation': 'Human Nutrition, School of Medicine, University of Glasgow, United Kingdom.'}]",Nutrition and health,['10.1177/0260106020942117']
1656,32726666,Intermittent theta burst stimulation over the dorsomedial prefrontal cortex modulates resting-state connectivity in depressive patients: A sham-controlled study.,"The mechanisms underlying repetitive transcranial magnetic stimulation (rTMS) treatment are largely unknown. Although there is a general lack of sham controlled studies, findings show altered functional connectivity to the stimulated region following treatment. When targeting the dorsolateral prefrontal cortex (dlPFC), connectivity with the subgenual anterior cingulate cortex (sgACC) is predictive of response, but less is known about the effects on functional connectivity of targeting the dorsomedial PFC (dmPFC). Here, 30 patients with an ongoing depressive episode were recruited and randomized to 20 sessions at target intensity of either active or sham intermittent theta burst stimulation (iTBS) over dmPFC. Those receiving sham were offered active treatment in a subsequent open phase. A seven minute resting-state scan and depressive symptom assessment was performed before and after treatment. After exclusions due to attrition and excessive head movements 23 patients remained for analysis. Seed-based resting-state connectivity was calculated using two seeds for the dmPFC target as well as the sgACC. A symptom related increase in dmPFC connectivity after active treatment, compared to sham treatment, was found. The effect was observed in a region overlapping the precuneus and the posterior cingulate cortex (PCC), suggesting an increase in the connectivity between the targeted salience network and the default mode network mediating improvement in depressive symptoms. Connectivity between the precuneus and both the sgACC and the treatment target was predictive of symptom improvement following active treatment. The findings have implications for understanding the mechanisms behind iTBS and may inform future efforts to individualize the treatment.",2020,Connectivity between the precuneus and both the sgACC and the treatment target was predictive of symptom improvement following active treatment.,"['30 patients with an ongoing depressive episode', 'depressive patients']","['repetitive transcranial magnetic stimulation (rTMS', 'Intermittent theta burst stimulation', 'active or sham intermittent theta burst stimulation (iTBS) over dmPFC']",['dmPFC connectivity'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}]","[{'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}]",30.0,0.0349908,Connectivity between the precuneus and both the sgACC and the treatment target was predictive of symptom improvement following active treatment.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden. Electronic address: jonas.persson@neuro.uu.se.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Struckmann', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gingnell', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden; Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Fällmar', 'Affiliation': 'Department of Surgical Sciences, Radiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bodén', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University, Uppsala, Sweden.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112834']
1657,32726727,Effects of a health education program targeted to Chinese women adhering to their cultural practice of doing the month: A randomized controlled trial.,"BACKGROUND


""Doing the month"" is a prevalent Chinese postpartum custom which is believed to restore health after delivery. However, some traditional practices are potentially harmful for women's health.
OBJECTIVES


To examine the effect of an evidence-based health education program on Chinese postpartum women's adherence to traditional practices of doing the month and the effect of adherence to doing the month on maternal physiological and psychological health.
METHODS


A randomized controlled trial was conducted. During December 2016-July 2017, we recruited postpartum women at a tertiary hospital. Women randomized to the intervention group received evidence-based health education within 1 week after returning home and received a second visit 1 month later. The control group received routine postpartum home visits. Adherence to doing the month was measured by the Adherence to Doing-the-Month Practices questionnaire (ADP). Maternal physical health was measured by the Chair Stand Test and Postpartum Symptom Checklist. Maternal psychological health was measured by the Edinburgh Postnatal Depression Scale (EPDS). Descriptive statistics, t-test, and chi-squared test were used to analyze the differences in scores and symptoms of the two groups.
RESULTS


We recruited 124 eligible postpartum women and 108 of them (54 intervention group, 54 control group) completed this study. The ADP score of the intervention group was significantly lower than that of the control group (p < 0.001). The number of participants in the experimental group with poor appetite and indigestion was significantly lower than that of control group. No significant differences were found in numbers of symptoms and average EPDS scores between the 2 study groups (p > 0.05).
CONCLUSIONS


Evidence-based health education can reduce postpartum women's adherence to some traditional practices of doing the month and improve women's physical health.",2020,"No significant differences were found in numbers of symptoms and average EPDS scores between the 2 study groups (p > 0.05).
","['During December 2016-July 2017, we recruited postpartum women at a tertiary hospital', '124 eligible postpartum women and 108 of them (54 intervention group, 54 control group) completed this study', ""Chinese postpartum women's"", 'Chinese women adhering to their cultural practice of doing the month']","['health education program', 'routine postpartum home visits', 'evidence-based health education program', 'evidence-based health education']","['Edinburgh Postnatal Depression Scale (EPDS', 'poor appetite and indigestion', 'Maternal physical health', 'ADP score', 'Maternal psychological health', 'numbers of symptoms and average EPDS scores', 'Chair Stand Test and Postpartum Symptom Checklist']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}]",124.0,0.0672713,"No significant differences were found in numbers of symptoms and average EPDS scores between the 2 study groups (p > 0.05).
","[{'ForeName': 'YanQun', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Wuhan University School of Health Sciences, China.'}, {'ForeName': 'JuYing', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Obstetrics Department of Hubei Maternal and Child Health Hospital, China.'}, {'ForeName': 'XiaoLi', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Wuhan University School of Health Sciences, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Emory University Nell Hodgson Woodruff School of Nursing, China. Electronic address: yuyun7169@163.com.'}, {'ForeName': 'JinBing', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Wuhan University School of Health Sciences, China.'}]",Midwifery,['10.1016/j.midw.2020.102796']
1658,32727624,"RECOVERY- Respiratory Support: Respiratory Strategies for patients with suspected or proven COVID-19 respiratory failure; Continuous Positive Airway Pressure, High-flow Nasal Oxygen, and standard care: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVE


The trial objective is to determine if Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) is clinically effective compared to standard oxygen therapy in patients with confirmed or suspected COVID-19.
TRIAL DESIGN


Adaptive (group-sequential), parallel group, pragmatic, superiority randomised controlled, open-label, multi-centre, effectiveness trial.
PARTICIPANTS


The trial is being conducted across approximately 60 hospitals across England, Wales, Scotland, and Northern Ireland. Inpatients at participating hospitals are eligible to participate if they have respiratory failure with suspected or proven COVID-19, and meet all of the inclusion criteria and none of the exclusion criteria.
INCLUSION CRITERIA


1) Adults ≥ 18 years; 2) Admitted to hospital with suspected or proven COVID-19; 3) Receiving oxygen with fraction of inspired oxygen (FiO 2 ) ≥0.4 and peripheral oxygen saturation (SpO 2 ) ≤94%; and 4) Plan for escalation to tracheal intubation if needed.
EXCLUSION CRITERIA


1) Planned tracheal intubation and mechanical ventilation imminent within 1 hour; 2) Known or clinically apparent pregnancy; 3) Any absolute contraindication to CPAP or HFNO; 4) Decision not to intubate due to ceiling of treatment or withdrawal of treatment anticipated; and 5) Equipment for both CPAP and HFNO not available.
INTERVENTION AND COMPARATOR


Intervention one: Continuous positive airway pressure delivered by any device. Set-up and therapy titration is not protocolised and is delivered in accordance with clinical discretion. Intervention two: High-flow nasal oxygen delivered by any device. Set-up and therapy titration is not protocolised and is delivered in accordance with clinical discretion. Comparator group: Standard care- oxygen delivered by face mask or nasal cannula (excluding the use of continuous positive airway pressure or high-flow nasal oxygen). Set-up and therapy titration is not protocolised and is delivered in accordance with clinical discretion. Intervention delivery continues up to the point of death, tracheal intubation, or clinical determination that there is no ongoing need (palliation or improvement).
MAIN OUTCOMES


The primary outcome is a composite outcome comprising tracheal intubation or mortality within 30 days following randomisation. Secondary outcomes include tracheal intubation rate, time to tracheal intubation, duration of invasive ventilation, mortality rate, time to mortality, length of hospital stay, and length of critical care stay.
RANDOMISATION


Participants are randomised in a 1:1:1 ratio to receive either continuous positive airway pressure, high-flow nasal oxygen or standard care. Due to the challenging environment of study delivery, a specific intervention may not always be available at the hospital site. The study uses two integrated randomisation systems to allow, where required, the site to randomise between all three interventions, between CPAP and standard care, and between HFNO and standard care. System integration ensures maintenance of balance between interventions. Randomisation is performed using a telephone-based interactive voice response system to maintain allocation concealment. The randomisation sequence was computer-generated using the minimisation method. Participant randomisation is stratified by site, gender (M/F), and age (<50, >=50 years).
BLINDING (MASKING)


The nature of the trial interventions precludes blinding of the researcher, patient and clinical team. Primary and secondary outcomes are all objective outcomes, thereby minimising the risk of detection bias.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


4002 participants (1334 to be randomized to each of the three study arms) TRIAL STATUS: Current protocol: Version 4.0, 29 th  May 2020. Recruitment began on April 6, 2020 and is anticipated to be complete by April 5, 2021. The trial has been awarded Urgent Public Health status by the National Institute of Health Research on 13 th  April 2020.
TRIAL REGISTRATION


ISRCTN, ISRCTN16912075. Registered 6 th  April 2020, http://www.isrctn.com/ISRCTN16912075 FULL PROTOCOL: The full protocol (version 4.0, 29 th  May 2020) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"Secondary outcomes include tracheal intubation rate, time to tracheal intubation, duration of invasive ventilation, mortality rate, time to mortality, length of hospital stay, and length of critical care stay.
","['approximately 60 hospitals across England, Wales, Scotland, and Northern Ireland', 'Adults ≥ 18 years', 'Inpatients at participating hospitals are eligible to participate if they have respiratory failure with suspected or proven COVID-19, and meet all of the inclusion criteria and none of the exclusion criteria', 'patients with suspected or proven COVID-19 respiratory failure; Continuous Positive Airway Pressure, High-flow Nasal Oxygen, and standard care', 'patients with confirmed or suspected COVID-19', ' 2) Admitted to hospital with suspected or proven COVID-19; 3) Receiving oxygen with fraction of inspired oxygen (FiO 2 ) ≥0.4 and peripheral oxygen saturation (SpO 2 ) ≤94%; and 4) Plan for escalation to tracheal intubation if needed', '4002 participants (1334 to be randomized to each of the three study arms']","['care- oxygen delivered by face mask or nasal cannula (excluding the use of continuous positive airway pressure or high-flow nasal oxygen', 'continuous positive airway pressure, high-flow nasal oxygen or standard care', 'Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO']","['tracheal intubation rate, time to tracheal intubation, duration of invasive ventilation, mortality rate, time to mortality, length of hospital stay, and length of critical care stay', 'composite outcome comprising tracheal intubation or mortality within 30 days following randomisation', 'objective outcomes, thereby minimising the risk of detection bias']","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0005346', 'cui_str': 'Biases'}]",4002.0,0.188009,"Secondary outcomes include tracheal intubation rate, time to tracheal intubation, duration of invasive ventilation, mortality rate, time to mortality, length of hospital stay, and length of critical care stay.
","[{'ForeName': 'Gavin D', 'Initials': 'GD', 'LastName': 'Perkins', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Couper', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Bronwen', 'Initials': 'B', 'LastName': 'Connolly', 'Affiliation': ""Wellcome Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'J Kenneth', 'Initials': 'JK', 'LastName': 'Baillie', 'Affiliation': 'The Roslin Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Judy M', 'Initials': 'JM', 'LastName': 'Bradley', 'Affiliation': ""Wellcome Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dark', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, NIHR Manchester Biomedical Research Centre, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'De Soyza', 'Affiliation': 'Institute of Cellular Medicine, NIHR Biomedical Research Centre for Ageing, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Gorman', 'Affiliation': ""Wellcome Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Alasdair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Emergency Medicine Research Group of Edinburgh, Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Hamilton', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hart', 'Affiliation': ""Centre for Human and Applied Physiological Sciences, King's College London, London, UK.""}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Lall', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'McGowan', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Regan', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Anita K', 'Initials': 'AK', 'LastName': 'Simonds', 'Affiliation': 'Sleep and Ventilation Unit, Royal Brompton and Harefield NHS Foundation Trust, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Skilton', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Stimpson', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Yeung', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'McAuley', 'Affiliation': ""Wellcome Wolfson Institute for Experimental Medicine, School of Medicine, Dentistry and Biomedical Science Queen's University Belfast, Belfast, UK. d.f.mcauley@qub.ac.uk.""}]",Trials,['10.1186/s13063-020-04617-3']
1659,32734423,Anticoagulant Use and Bleeding Risk in Central European Patients with Idiopathic Pulmonary Fibrosis (IPF) Treated with Antifibrotic Therapy: Real-World Data from EMPIRE.,"INTRODUCTION


Nintedanib, a tyrosine kinase receptor inhibitor, may be associated with increased bleeding risk. Thus, patients with an inherited predisposition to bleeding, or those receiving therapeutic doses of anticoagulants or high-dose antiplatelet therapy, have been excluded from clinical trials of nintedanib in idiopathic pulmonary fibrosis (IPF).
OBJECTIVE


Our objective was to examine real-world bleeding events in patients with IPF treated with antifibrotics, including those receiving anticoagulants and/or antiplatelet therapy.
METHODS


The European MultiPartner IPF Registry (EMPIRE) enrolled 2794 patients with IPF: group A (1828: no anticoagulant or antiplatelet treatment), group B (227: anticoagulant treatment), group C (659: antiplatelet treatment), and group D (80: anticoagulant and antiplatelet treatment). Overall, 673 (24.1%) received nintedanib and 933 (33.4%) received pirfenidone. Bleeding events and their relationship to antifibrotic and anticoagulation treatment were characterized.
RESULTS


Group A patients, versus those in groups B, C, and D, were typically younger and generally had the lowest comorbidity rates. A higher proportion of patients in groups A and C, versus group B, received nintedanib. Pirfenidone, most common in group D, was more evenly balanced across groups. In patients with reported bleeding events, seven of eight received nintedanib (groups A, C, and D). Bleeding incidence was 3.0, 0, 1.3, and 18.1 per 10,000 patient-years (groups A, B, C, and D, respectively).
CONCLUSION


Real-world data from EMPIRE showed that patients on anticoagulant medications received nintedanib less frequently, perhaps based on its mechanism of action. Overall, bleeding incidence was low (0.29%: nintedanib 0.25%; pirfenidone 0.04%) and irrespective of anticoagulant or antiplatelet therapy received (P = 0.072).",2020,"Overall, bleeding incidence was low (0.29%: nintedanib 0.25%; pirfenidone 0.04%) and irrespective of anticoagulant or antiplatelet therapy received (P = 0.072).","['2794 patients with IPF: group A', 'patients with an inherited predisposition to bleeding, or those receiving therapeutic doses of anticoagulants or high-dose antiplatelet therapy, have been excluded from clinical trials of nintedanib in idiopathic pulmonary fibrosis (IPF', 'Central European Patients with Idiopathic Pulmonary Fibrosis (IPF', 'patients with IPF treated with antifibrotics, including those receiving anticoagulants and/or antiplatelet therapy']","['Pirfenidone', 'pirfenidone']","['Bleeding incidence', 'Bleeding events', 'Anticoagulant Use and Bleeding Risk', 'Overall, bleeding incidence', 'bleeding events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0314657', 'cui_str': 'Genetic predisposition'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0298067', 'cui_str': 'pirfenidone'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",2794.0,0.0171192,"Overall, bleeding incidence was low (0.29%: nintedanib 0.25%; pirfenidone 0.04%) and irrespective of anticoagulant or antiplatelet therapy received (P = 0.072).","[{'ForeName': 'Abigél M', 'Initials': 'AM', 'LastName': 'Kolonics-Farkas', 'Affiliation': 'Department of Pulmonology, Semmelweis University, Tömő utca 25-29, Budapest, 1083, Hungary. kolonics-farkas.abigel@med.semmelweis-univ.hu.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Šterclová', 'Affiliation': 'Department of Respiratory Diseases of the First Faculty of Medicine, Charles University, Thomayer Hospital, Prague, Czech Republic.'}, {'ForeName': 'Nesrin', 'Initials': 'N', 'LastName': 'Mogulkoc', 'Affiliation': 'Department of Pulmonary Medicine, Ege University Medical School, Izmir, Turkey.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kus', 'Affiliation': 'Department of Pulmonary Diseases, Institute of Tuberculosis and Lung Diseases, Warsaw, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Hájková', 'Affiliation': 'Clinic of Pneumology and Phthisiology, University Hospital Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Department of Pulmonology, Semmelweis University, Tömő utca 25-29, Budapest, 1083, Hungary.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Jovanovic', 'Affiliation': 'University Hospital of Pulmonology, Clinical Center of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Jasna', 'Initials': 'J', 'LastName': 'Tekavec-Trkanjec', 'Affiliation': 'Pulmonary Department, University Hospital Dubrava, Zagreb, Croatia.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Littnerová', 'Affiliation': 'Institute of Biostatistics and Analyses, Masaryk University, Faculty of Medicine, Brno, Czech Republic.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Hejduk', 'Affiliation': 'Institute of Biostatistics and Analyses, Masaryk University, Faculty of Medicine, Brno, Czech Republic.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Vašáková', 'Affiliation': 'Department of Respiratory Diseases of the First Faculty of Medicine, Charles University, Thomayer Hospital, Prague, Czech Republic.'}]",Drug safety,['10.1007/s40264-020-00978-5']
1660,32734815,Salt intake impacts sympathetic neural control but not morning blood pressure surge in premenopausal women with a history of normal pregnancy.,"Salt intake may alter blood pressure (BP) regulation, but no study has investigated the impact of salt reduction versus salt loading on morning blood pressure surge (MBPS) and sympathetic neural control in premenopausal women with a history of normal pregnancy. Nine healthy women (42 ± 3 yr; mean ± SD) were given a low-salt diet (LS; 50 mEq sodium/day) and high-salt diet (HS; 250 mEq sodium/day) for 1 wk each (~2 mo apart with the order randomized), while water intake was ad libitum. Ambulatory BP at 24 h was measured, and the percent change in blood volume (BV) was calculated following LS and HS. MBPS was defined as the morning systolic BP (averaged for 2 h after wake-up) minus the lowest nocturnal systolic BP. Beat-by-beat BP, heart rate, and muscle sympathetic nerve activity (MSNA) were measured during supine rest. Signal averaging was used to characterize changes in beat-by-beat mean arterial pressure and total vascular conductance following spontaneous MSNA bursts to assess sympathetic vascular transduction. Ambulatory BP and MBPS (32 ± 7 vs. 26 ± 12 mmHg,  P  = 0.208) did not differ between LS and HS. From LS to HS, BV increased by 4.3 ± 3.7% ( P  = 0.008). MSNA (30 ± 20 vs. 18 ± 13 bursts/100 heartbeats,  P  = 0.005) was higher, whereas sympathetic vascular transduction was lower in LS than HS (both,  P  < 0.01). Changes in MSNA from LS to HS were correlated to percent changes in BV ( r  = -0.673;  P  = 0.047). Thus, salt intake affects sympathetic neural control but not MBPS in premenopausal women with a history of normal pregnancy. The underlying mechanisms remain unknown; however, alterations in sympathetic vascular transduction may, in part, contribute. NEW & NOTEWORTHY  This is the first study to demonstrate that MBPS and ambulatory BP were not affected by salt intake despite a significant change in sympathetic outflow in healthy premenopausal women with a history of normal pregnancy. This may be due to compensatory adaptations in MSNA and sympathetic vascular transduction during salt reduction versus salt loading.",2020,"From LS to HS, BV increased by 4.3±3.7% (p=0.008).","['Nine healthy women [42±3 (SD) yr', 'premenopausal women with a history of normal pregnancy', 'Premenopausal Women with A History of Normal Pregnancy']","['Salt Intake Impacts Sympathetic Neural Control', 'low-salt (LS; 50 mEq sodium/day) and high-salt diet (HS; 250 mEq sodium/day) for 1 week each', 'salt reduction versus salt loading']","['blood pressure (BP) regulation', 'MBPS', 'morning systolic BP', 'Beat-by-beat BP, heart rate, and muscle sympathetic nerve activity (MSNA', 'blood volume (BV', 'sympathetic vascular transduction', 'Ambulatory BP and MBPS', 'nocturnal systolic BP']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0232989', 'cui_str': 'Normal pregnancy'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439152', 'cui_str': 'mEq'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",9.0,0.0561719,"From LS to HS, BV increased by 4.3±3.7% (p=0.008).","[{'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Takeda', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas.'}, {'ForeName': 'Abigail S', 'Initials': 'AS', 'LastName': 'Stickford', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Best', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas.'}, {'ForeName': 'Jeung-Ki', 'Initials': 'JK', 'LastName': 'Yoo', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': 'Institute for Exercise and Environmental Medicine, Texas Health Presbyterian Hospital Dallas, Dallas, Texas.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00197.2020']
1661,32730283,"Comparison of Glidescope® Go™, King Vision™, Dahlhausen VL, I‑View™ and Macintosh laryngoscope use during difficult airway management simulation by experienced and inexperienced emergency medical staff: A randomized crossover manikin study.","BACKGROUND


In pre-hospital emergency care, video laryngoscopes (VLs) with disposable blades are preferably used due to hygienic reasons. However, there is limited existing data on the use of VLs with disposable blades by emergency medical staff. Therefore, the aim of this study was to compare the efficacy of four different VLs with disposable blades and the conventional standard Macintosh laryngoscope, when used by anesthetists with extensive previous experience and paramedics with little previous experience in endotracheal intubation (ETI) in a simulated difficult airway.
METHODS


Fifty-eight anesthetists and fifty-four paramedics participated in our randomized crossover manikin trial. Each performed ETI with the new Glidescope® Go™, the Dahlhausen VL, the King Vision™, the I-View™ and the Macintosh laryngoscope. ""Time to intubate"" was the primary endpoint. Secondary endpoints were ""time to vocal cords"", ""time to ventilate"", overall success rate, number of intubation attempts and optimization maneuvers, Cormack-Lehane score, severity of dental compression and subjective impressions.
RESULTS


The Glidescope® Go™, the Dahlhausen VL and the King Vision™ provided superior intubation conditions in both groups without affecting the number of intubation attempts or the time required for successful intubation. When used by anesthetists with extensive experience in ETI, the use of VLs did not affect the overall success rate. In the hands of paramedics with little previous experience in ETI, the failure rate with the Macintosh laryngoscope (14.8%) decreased to 3.7% using the Glidescope® Go™ and the Dahlhausen VL. Despite the advantages of hyperangulated video laryngoscopes, the I-View™ performed worst.
CONCLUSIONS


VLs with hyperangulated blades facilitated ETI in both groups and decreased the failure rate by an absolute 11.1% when used by paramedics with little previous experience in ETI. Our results therefore suggest that hyperangulated VLs could be beneficial and might be the method of choice in comparable settings, especially for emergency medical staff with less experience in ETI.",2020,"CONCLUSIONS


VLs with hyperangulated blades facilitated ETI in both groups and decreased the failure rate by an absolute 11.1% when used by paramedics with little previous experience in ETI.",['Fifty-eight anesthetists and fifty-four paramedics participated'],"['conventional standard Macintosh laryngoscope', 'endotracheal intubation (ETI']","['number of intubation attempts or the time required for successful intubation', 'overall success rate', 'failure rate', 'Dahlhausen VL and the King Vision™', 'time to vocal cords"", ""time to ventilate"", overall success rate, number of intubation attempts and optimization maneuvers, Cormack-Lehane score, severity of dental compression and subjective impressions']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",58.0,0.028898,"CONCLUSIONS


VLs with hyperangulated blades facilitated ETI in both groups and decreased the failure rate by an absolute 11.1% when used by paramedics with little previous experience in ETI.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Moritz', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Leonhardt', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Prottengeier', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Birkholz', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Irouschek', 'Affiliation': 'Department of Anesthesiology, University Hospital Erlangen, Faculty of Medicine, Friedrich-Alexander-Universität (FAU) Erlangen-Nürnberg, Erlangen, Germany.'}]",PloS one,['10.1371/journal.pone.0236474']
1662,32730797,Balance training monitoring and individual response during unstable vs. stable balance Exergaming in elderly adults: Findings from a randomized controlled trial.,"OBJECTIVE


Exercise-based fall prevention programs mainly refer to multimodal and challenging balance exercises. Individual load monitoring and interpretations are crucial to enable adequate adaptation responses on the individual level. Thus, assessing internal responses to external stimuli throughout an intervention period need to be adequately addressed. The aim of this secondary analysis of a 3-armed randomized controlled trial was to analyze internal and external loads of unstable vs. stable balance Exergame training in healthy seniors. We intended to elucidate whether differences of external and internal load criteria occur over the intervention period.
METHODS


A total of 51 healthy seniors (females: n = 34; males: n = 17; age: 69 ± 6 years; BMI: 27 ± 5) were allocated to either volitional stepping (VOL), volitional stepping under unstable conditions (VOL + US) or an inactive control group (CON). VOL and VOL + US completed 8 weeks of Exergame based step training (three weekly sessions, 45 min each) using the Dividat Senso device. Twelve different balance Exergames were used, consisting of virtual reality like video games. The original nonswinging, stable platform was employed for VOL, whereas VOL + US used an adapted Senso mounted on a swinging Posturomed Rack. The instability level was increased for VOL + US only every second week. External (game scores) and internal (perceived efforts, using the rated perceived exertion scale (RPE)) load measures were individually recorded for every session. Statistical analysis was carried out using linear mixed-effects modelling.
RESULTS


Although VOL + US completed similar games at identical training volumes under unstable conditions, the achieved game scores did not significantly differ between both training groups (p = 0.71). Both intervention groups notably improved their game scores over the 8 training weeks (p < 0.01). A significant time x group interaction effect was observed for perceived effort (p < 0.01), serving as an internal load measure. Subsequent post-hoc testing revealed significant greater perceived exertion values in each of the first 7 weeks (p < 0.05) in VOL + US compared to VOL. No between-group differences were found for RPE in week 8. Whereas RPE values in VOL + US decreased over time (week 1: 4.6 ± 1.9; week 8: 3.1 ± 1.6), VOL indicated similar RPE values for all weeks (week 1: 3.1 ± 1.3; week 8: 2.9 ± 1.4). A detailed analysis of all twelve games revealed that differences in perceived exertion depend on the game content: in 75% of the involved games the RPE level was significantly higher in VOL + US compared to VOL (p < 0.05).
CONCLUSION


Monitoring internal and external loads on individual level are paramount for gaining adequate training adaptations. Our results indicate that between-group differences in perceived efforts a) can funnel over time, b) depend on game content and c) do not necessarily affect overall scoring. Future studies should individually employ and monitor measures of perceived efforts to guarantee an adequate challenge to the balance system within exercise-based fall prevention programs.",2020,Both intervention groups notably improved their game scores over the 8 training weeks (p < 0.01).,"['51 healthy seniors (females: n\u202f=\u202f34; males: n\u202f=\u202f17; age: 69\u202f±\u202f6\u202fyears; BMI: 27\u202f±\u202f5', 'healthy seniors', 'elderly adults']","['unstable vs. stable balance Exergame training', 'volitional stepping (VOL), volitional stepping under unstable conditions (VOL\u202f+\u202fUS) or an inactive control group (CON', 'Balance training monitoring', 'Exercise-based fall prevention programs']","['instability level', 'game scores', 'perceived exertion', 'RPE values', 'exertion values', 'RPE level', 'External (game scores) and internal (perceived efforts, using the rated perceived exertion scale (RPE)) load measures']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",51.0,0.0158194,Both intervention groups notably improved their game scores over the 8 training weeks (p < 0.01).,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Institute of Exercise Training and Sport Informatics, German Sport University, Cologne, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Donath', 'Affiliation': 'Institute of Exercise Training and Sport Informatics, German Sport University, Cologne, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Rein', 'Affiliation': 'Institute of Exercise Training and Sport Informatics, German Sport University, Cologne, Germany. Electronic address: r.rein@dshs-koeln.de.'}]",Experimental gerontology,['10.1016/j.exger.2020.111037']
1663,32730798,"Efficacy and safety of osilodrostat in patients with Cushing's disease (LINC 3): a multicentre phase III study with a double-blind, randomised withdrawal phase.","BACKGROUND


Cushing's disease is a rare endocrine disorder characterised by cortisol overproduction with severe complications. Therapies for cortisol reduction are often necessary. Here we report the outcomes from the pivotal phase III study of osilodrostat (a potent oral inhibitor of cytochrome P450 11B1, mitochondrial [11β-hydroxylase]; Novartis Pharma AG, Basel, Switzerland) in patients with Cushing's disease.
METHODS


LINC 3 was a prospective, multicentre, open-label, phase III study with a double-blind randomised withdrawal period, that comprised four periods. Patients aged 18-75 years, with confirmed persistent or recurrent Cushing's disease (defined as mean 24-h urinary free cortisol [UFC] concentration >1·5 times the upper limit of normal [ULN] and morning plasma adrenocorticotropic hormone above the lower limit of normal) who had previously had pituitary surgery or irradiation, or were newly diagnosed and who refused surgery or were not surgical candidates, were recruited from 66 hospital sites and private clinical practices in 19 countries. In period 1, open-label osilodrostat was initiated in all participants and adjusted every 2 weeks (1-30 mg twice daily; film-coated tablets for oral administration) on the basis of mean 24-h UFC concentration and safety until week 12. In period 2, weeks 13-24, osilodrostat was continued at the therapeutic dose determined during period 1. In period 3, beginning at week 26, participants who had a mean 24-h UFC concentration of less than or equal to the ULN at week 24, without up-titration after week 12, were randomly assigned (1:1), via an interactive-response technology, stratified by osilodrostat dose at week 24 and history of pituitary irradiation, to continue osilodrostat or switch to placebo for 8 weeks. Participants and investigators were masked to treatment assignment. Ineligible participants continued open-label osilodrostat. In period 4, weeks 35-48, all participants were given open-label osilodrostat until core-study end. The primary objective was to compare the efficacy of osilodrostat versus placebo at the end of period 3. The primary endpoint was the proportion of participants who had been randomly assigned to treatment or placebo with a complete response (ie, mean 24-h UFC concentration of ≤ULN) at the end of the randomised withdrawal period (week 34), without up-titration during this period. The key secondary endpoint was the proportion of participants with a complete response at the end of the single-arm, open-label period (ie, period 2, week 24) without up-titration during weeks 13-24. Analysis was by intention-to-treat for all patients who received at least one dose of osilodrostat (full analysis set; key secondary endpoint) or randomised treatment (randomised analysis set; primary endpoint) and safety was assessed in all enrolled patients who received at least one dose of osilodrostat and had at least one post-baseline safety assessment. LINC 3 is registered with ClinicalTrials.gov, NCT02180217, and is now complete.
FINDINGS


Between Nov 12, 2014, and March 22, 2017, 202 patients were screened and 137 were enrolled. The median age was 40·0 years (31·0-49·0) and 106 (77%) participants were female. 72 (53%) participants were eligible for randomisation during the withdrawal phase, of whom 36 were assigned to continue osilodrostat and 35 were assigned to placebo; one patient was not randomly assigned due to investigator decision and continued open-label osilodrostat. More patients maintained a complete response with osilodrostat versus with placebo at week 34 (31 [86%] vs ten [29%]; odds ratio 13·7 [95% CI 3·7-53·4]; p<0·0001). At week 24, 72 (53%; 95% CI 43·9-61·1) of 137 patients maintained a complete response without up-titration after week 12. Most common adverse events (ie, occurred in >25% of participants) were nausea (57 [42%]), headache (46 [34%]), fatigue (39 [28%]), and adrenal insufficiency (38 [28%]). Hypocortisolism occurred in 70 (51%) patients and adverse events related to adrenal hormone precursors occurred in 58 (42%) patients. One patient died, unrelated to study drug, after the core study phase.
INTERPRETATION


Twice-daily osilodrostat rapidly reduced mean 24-h UFC and sustained this reduction alongside improvements in clinical signs of hypercortisolism; it was also generally well tolerated. Osilodrostat is an effective new treatment option that is approved in Europe for the treatment of endogenous Cushing's syndrome and in the USA for Cushing's disease.
FUNDING


Novartis Pharma AG.",2020,More patients maintained a complete response with osilodrostat versus with placebo at week 34 (31 [86%] vs ten [29%]; odds ratio 13·7 [95% CI 3·7-53·4]; p<0·0001).,"[""patients with Cushing's disease"", '72 (53%) participants were eligible for randomisation during the withdrawal phase, of whom 36 were assigned to continue osilodrostat and 35 were assigned to', 'participants who had a mean 24-h UFC concentration of less than or equal to the ULN at week 24, without up-titration after week 12', 'Between Nov 12, 2014, and March 22, 2017, 202 patients were screened and 137 were enrolled', '137 patients', 'The median age was 40·0 years (31·0-49·0) and 106 (77%) participants were female', ""Patients aged 18-75 years, with confirmed persistent or recurrent Cushing's disease (defined as mean 24-h urinary free cortisol [UFC] concentration >1·5 times the upper limit of normal [ULN] and morning plasma adrenocorticotropic hormone above the lower limit of normal) who had previously had pituitary surgery or irradiation, or were newly diagnosed and who refused surgery or were not surgical candidates, were recruited from 66 hospital sites and private clinical practices in 19 countries"", ""patients with Cushing's disease (LINC 3""]","['osilodrostat versus placebo', 'investigator decision and continued open-label osilodrostat', 'osilodrostat', 'placebo']","['headache', 'adrenal hormone precursors', 'proportion of participants with a complete response', 'fatigue', 'complete response (ie, mean 24-h UFC concentration of ≤ULN', 'Efficacy and safety', 'adrenal insufficiency', 'nausea', 'Hypocortisolism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0221406', 'cui_str': 'Pituitary dependent hypercortisolism'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0474662', 'cui_str': 'Cortisol measurement, free, urine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C1271647', 'cui_str': 'Plasma ACTH level'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C1445654', 'cui_str': 'Adrenal hormone'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001623', 'cui_str': 'Hypoadrenalism'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0001403', 'cui_str': ""Addison's disease""}]",202.0,0.359008,More patients maintained a complete response with osilodrostat versus with placebo at week 34 (31 [86%] vs ten [29%]; odds ratio 13·7 [95% CI 3·7-53·4]; p<0·0001).,"[{'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Pivonello', 'Affiliation': 'Dipartimento di Medicina Clinica e Chirurgia, Sezione di Endocrinologia, Università Federico II di Napoli, Naples, Italy. Electronic address: rosario.pivonello@unina.it.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Fleseriu', 'Affiliation': 'Northwest Pituitary Center, Departments of Medicine and Neurological Surgery, Oregon Health and Science University, Portland, OR, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Newell-Price', 'Affiliation': 'Department of Oncology and Metabolism, The Medical School, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Bertagna', 'Affiliation': 'Department of Endocrinology, Centre de Référence des Maladies Rares de la Surrénale, Hôpital Cochin, Faculté de Médecine Paris Descartes, Université Paris 5, Paris, France.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Findling', 'Affiliation': 'Division of Endocrinology and Molecular Medicine, Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shimatsu', 'Affiliation': 'Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Kyoto, Japan; Advanced Medical Care Center, Kusatsu General Hospital, Kusatsu, Japan.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Gu', 'Affiliation': 'Department of Endocrinology, Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Auchus', 'Affiliation': 'Division of Metabolism, Endocrinology and Diabetes, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Rattana', 'Initials': 'R', 'LastName': 'Leelawattana', 'Affiliation': 'Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Eun Jig', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': 'Pituitary Tumor Center, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jung Hee', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Lacroix', 'Affiliation': ""Centre hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Laplanche', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': ""O'Connell"", 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Libuse', 'Initials': 'L', 'LastName': 'Tauchmanova', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Pedroncelli', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Beverly M K', 'Initials': 'BMK', 'LastName': 'Biller', 'Affiliation': 'Neuroendocrine and Pituitary Tumor Clinical Center, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30240-0']
1664,32730842,The association between REM sleep and decision-making: Supporting evidences.,"Studies suggest that REM sleep is important for the maintenance of prefrontal cortex functioning. Therefore, reducing REM sleep may have an impact on cognitive functions such as impulse control and decision-making processes. This study examined the association between impulsiveness and sensation seeking personality traits, REM sleep and performance on a decision-making computer task following a habitual night of sleep and a partial sleep deprivation (PSD) condition with advanced wake-up time. Eighteen young adults participated in two experimental conditions: a control (habitual bedtime and wake time) and a 50% PSD with an advanced wake time. Impulsiveness and sensation seeking personality traits were measured with a personality inventory (NEO-PI-3), sleep was assessed using standard polysomnography and the Iowa Gambling Task (IGT) was completed at noon following each sleep condition. Results showed that when sleep deprived, participants choose more often to play riskier decks of cards during the last half of the IGT. Results also showed that REM sleep duration and REM sleep deprivation were associated with riskier decisions on the IGT. Moreover, impulsiveness was associated with riskier decisions after a normal night of sleep. These findings suggest that REM sleep duration and impulsiveness are important factors to consider while investigating decision-making processes under conditions of uncertainty and risk.",2020,"Results showed that when sleep deprived, participants choose more often to play riskier decks of cards during the last half of the IGT.",['Eighteen young adults'],['control (habitual bedtime and wake time) and a 50% PSD with an advanced wake time'],"['personality inventory (NEO-PI-3), sleep was assessed using standard polysomnography and the Iowa Gambling Task (IGT', 'REM sleep duration and REM sleep deprivation', 'Impulsiveness and sensation seeking personality traits']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0142580', 'cui_str': 'PI3 protein, human'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0751506', 'cui_str': 'REM Sleep Deprivation'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0871336', 'cui_str': 'Sensation seeking'}, {'cui': 'C0233849', 'cui_str': 'Character trait finding'}]",18.0,0.0117207,"Results showed that when sleep deprived, participants choose more often to play riskier decks of cards during the last half of the IGT.","[{'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Brunet', 'Affiliation': 'Laboratoire du Sommeil, Département de Psychoéducation et de Psychologie, Université du Québec en Outaouais, Gatineau, Canada, J8X 3X7.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'McNeil', 'Affiliation': 'Behavioral and Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, Canada, K1N 6N5.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Doucet', 'Affiliation': 'Behavioral and Metabolic Research Unit, School of Human Kinetics, University of Ottawa, Ottawa, Canada, K1N 6N5.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Forest', 'Affiliation': 'Laboratoire du Sommeil, Département de Psychoéducation et de Psychologie, Université du Québec en Outaouais, Gatineau, Canada, J8X 3X7. Electronic address: genevieve.forest@uqo.ca.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113109']
1665,32730985,"Randomized clinical trial: expanded autologous bone marrow mesenchymal cells combined with allogeneic bone tissue, compared with autologous iliac crest graft in lumbar fusion surgery.","BACKGROUND CONTEXT


Although autogenous iliac crest bone graft (AICBG) is considered the gold-standard graft material for spinal fusion, new bone substitutes are being developed to avoid associated complications and disadvantages. By combining autologous bone marrow mesenchymal stromal cells (MSCs) expanded ex vivo and allogenic cancellous bone graft, we obtain a tissue-engineered product that is osteoconductive and potentially more osteogenic and osteoinductive than AICBG, owing to the higher concentration of MSCs.
PURPOSE


This study aimed to evaluate the feasibility and safety of implanting a tissue-engineered product consisting of expanded bone marrow MSCs loaded onto allograft bone (MSC+allograft) for spinal fusion in degenerative spine disease, as well as to assess its clinical and radiological efficacy.
STUDY DESIGN/SETTING


A prospective, multicenter, open-label, blinded-reader, randomized, parallel, single-dose phase I-II clinical trial.
PATIENT SAMPLE


A total of 73 adult patients from 5 hospitals, with Meyerding grade I-II L4-L5 degenerative spondylolisthesis and/or with L4-L5 degenerative disc disease who underwent spinal fusion through transforaminal lumbar interbody fusion (TLIF).
OUTCOME MEASURES


Spinal fusion was assessed by plain X-ray at 3, 6, and 12 months and by computed tomography (CT) at 6 and 12 months post-treatment. An independent radiologist performed blinded assessments of all images. Clinical outcomes were measured as change from baseline value: visual analog scale for lumbar and sciatic pain at 12 days, 3, 6, and 12 months posttreatment, and Oswestry Disability Index and Short Form-36 at 3, 6, and 12 months posttreatment.
METHODS


Patients who underwent L4-L5 TLIF were randomized for posterior graft type only, and received either MSC+allograft (the tissue-engineered product, group A) or AICBG (standard graft material, group B). Standard graft material was used for anterior fusion in all patients. Feasibility was measured primarily as the percentage of randomized patients who underwent surgery in each treatment group. Safety was assessed by analyzing treatment-emergent adverse events (AEs) for the full experimental phase and appraising their relationship to the experimental treatment. Outcome measures, both radiological and clinical, were compared between the groups.
RESULTS


Seventy-three patients were randomized in this study, 36 from the MSC+allograft group and 37 from the AICBG group, and 65 were surgically treated (31 group A, 34 group B). Demographic and comorbidity data showed no difference between groups. Most patients were diagnosed with grade I or II degenerative spondylolisthesis. MSC+allograft was successfully implanted in 86.1% of randomized group A patients. Most patients suffered treatment-emergent AEs during the study (88.2% in group A and 97.1% in group B), none related to the experimental treatment. X-ray-based rates of posterior spinal fusion were significantly higher for the experimental group at 6 months (p=.012) and 12 months (p=.0003). CT-based posterior fusion rates were significantly higher for MSC+allograft at 6 months (92.3% vs 45.7%; p=.0001) and higher, but not significantly, at 12 months (76.5% vs 65.7%; p=.073). CT-based complete response (defined as the presence of both posterior intertransverse fusion and anterior interbody fusion) was significantly higher at 6 months for MSC+allograft than for AICBG (70.6% vs 40%; p=.0038), and remained so at 12 months (70.6% vs 51.4%; p=.023). Clinical results including patient-reported outcomes improved postsurgery, although there were no differences between groups.
CONCLUSIONS


Compared with the current gold standard, our experimental treatment achieved a higher rate of posterior spinal fusion and radiographic complete response to treatment at 6 and 12 months after surgery. The treatment clearly improved patient quality of life and decreased pain and disability at rates similar to those for the control arm. The safety profile of the tissue-engineered product was also similar to that for the standard material, and no AEs were linked to the product. Procedural AEs did not increase as a result of BM aspiration. The use of expanded bone marrow MSCs combined with cancellous allograft is a feasible and effective technique for spinal fusion, with no product-related AEs found in our study.",2020,"CT-based posterior fusion rates were significantly higher for MSC+allograft at 6 months (92.3% vs 45.7%; p=.0001) and higher, but not significantly, at 12 months (76.5% vs 65.7%; p=.073).","['73 adult patients from 5 hospitals, with Meyerding grade I-II L4-L5 degenerative spondylolisthesis and/or with L4-L5 degenerative disc disease who underwent spinal fusion through transforaminal lumbar interbody fusion (TLIF', 'Patients who underwent', 'Most patients were diagnosed with grade I or II degenerative spondylolisthesis', 'Seventy-three patients were randomized in this study, 36 from the MSC+allograft group and 37 from the AICBG group, and 65 were surgically treated (31 group A, 34 group B', 'lumbar fusion surgery']","['autologous bone marrow mesenchymal cells combined with allogeneic bone tissue', 'autogenous iliac crest bone graft (AICBG', 'autologous iliac crest graft', 'implanting a tissue-engineered product consisting of expanded bone marrow MSCs loaded onto allograft bone (MSC+allograft', 'autologous bone marrow mesenchymal stromal cells (MSCs', 'MSC+allograft', 'L4-L5', 'expanded bone marrow MSCs combined with cancellous allograft', 'MSC+allograft (the tissue-engineered product, group A) or AICBG']","['Safety', 'CT-based complete response', 'rate of posterior spinal fusion and radiographic complete response', 'patient quality of life and decreased pain and disability', 'Oswestry Disability Index (ODI) and Short Form-36 (SF-36', 'X-ray-based rates of posterior spinal fusion', 'CT-based posterior fusion rates', 'change from baseline value: visual analog scale (VAS) for lumbar and sciatic pain', 'feasibility and safety', 'BM aspiration', 'Feasibility']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0264184', 'cui_str': 'Degenerative spondylolisthesis'}, {'cui': 'C0158266', 'cui_str': 'Degeneration of intervertebral disc'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0223651', 'cui_str': 'Iliac crest structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0391978', 'cui_str': 'Bone (tissue) structure'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0223651', 'cui_str': 'Iliac crest structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0596171', 'cui_str': 'Tissue Engineering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C3178844', 'cui_str': 'Mesenchymal Stromal Cells'}, {'cui': 'C0407564', 'cui_str': 'Allogeneic bone graft'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}]",73.0,0.125911,"CT-based posterior fusion rates were significantly higher for MSC+allograft at 6 months (92.3% vs 45.7%; p=.0001) and higher, but not significantly, at 12 months (76.5% vs 65.7%; p=.073).","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'García de Frutos', 'Affiliation': 'Department of Orthopedic Surgery, Hospital Vall d´Hebron, Barcelona, Spain; Department of Orthopedic Surgery, ICATME, Hospital Universitari Quiron Dexeus, Barcelona, Spain; Univ Autonoma de Barcelona, Spain. Electronic address: agf.agfrutos@gmail.com.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'González-Tartière', 'Affiliation': ""Spine research unit, Vall d'Hebron Research Institute, Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Coll Bonet', 'Affiliation': 'Banc de Sang i Teixits de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Ubierna Garcés', 'Affiliation': 'Department of Orthopedic Surgery, ICATME, Hospital Universitari Quiron Dexeus, Barcelona, Spain; Department of Orthopedic Surgery, Hospital Germas Trias i Pujol, Badalona, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Del Arco Churruca', 'Affiliation': 'Department of Orthopedic Surgery, Hospital de Sant Pau, Barcelona, Spain; Unitat Funcional de Cirurgia de la Columna Vertebral, Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Rivas García', 'Affiliation': ""Department of Radiodiagnosis, Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Matamalas Adrover', 'Affiliation': 'Department of Orthopedic Surgery, Hospital Vall d´Hebron, Barcelona, Spain.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Saló Bru', 'Affiliation': 'Univ Autonoma de Barcelona, Spain; Unitat Funcional de Cirurgia de la Columna Vertebral, Parc de Salut Mar, Barcelona, Spain.'}, {'ForeName': 'Juan Jose', 'Initials': 'JJ', 'LastName': 'Velazquez', 'Affiliation': 'Department of Orthopedic Surgery, Hospital de Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Vila-Canet', 'Affiliation': 'Department of Orthopedic Surgery, ICATME, Hospital Universitari Quiron Dexeus, Barcelona, Spain; Department of Orthopedic Surgery, Hospital de Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'García-Lopez', 'Affiliation': 'Banc de Sang i Teixits de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Vives', 'Affiliation': ""Univ Autonoma de Barcelona, Spain; Banc de Sang i Teixits de Catalunya, Barcelona, Spain; Musculoskeletal Tissue Engineering Group, Vall d'Hebron Research Institute, Barcelona, Spain.""}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Codinach', 'Affiliation': 'Banc de Sang i Teixits de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Rodriguez', 'Affiliation': 'Banc de Sang i Teixits de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Bagó Granell', 'Affiliation': 'Department of Orthopedic Surgery, Hospital Vall d´Hebron, Barcelona, Spain.'}, {'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Càceres Palou', 'Affiliation': 'Department of Orthopedic Surgery, Hospital Vall d´Hebron, Barcelona, Spain; Department of Orthopedic Surgery, ICATME, Hospital Universitari Quiron Dexeus, Barcelona, Spain; Univ Autonoma de Barcelona, Spain.'}]",The spine journal : official journal of the North American Spine Society,['10.1016/j.spinee.2020.07.014']
1666,32731011,The effect of Hatha yoga intervention on students' creative ability.,"There is increasing demand for individual creativity as organizations seek innovative ways to remain relevant. Higher education institutions, particularly business schools, are sensitive to this demand and are constantly in search for innovative ways to enhance the creative ability of their students. Prior studies have shown encouraging results for physical activity-oriented interventions. Building on this research, this study uses Randomized Controlled Trial (RCT) to understand if an acute combinatory intervention, involving both physical and mental exercises embodied in Hatha yoga can improve individual creativity. This study uses 92 MBA student participants to investigate the impact of a 20-minute Hatha yoga session intervention against a short 20-minute case study session for the control group. Creative ability of the participants is operationalized through divergent and convergent thinking, which are then assessed through counter-balanced forms of Guilford Alternate Uses tasks and Remote Associate Test, respectively. The results show that while Hatha yoga significantly improves divergent thinking, the control group shows deterioration in divergent thinking. There is no effect on convergent thinking. These findings lend some support to the executive function hypothesis. The study also finds that prodding a person to be more creative on a routine academic task may not enhance their creative ability.",2020,There is no effect on convergent thinking.,"['92 MBA student participants', ""students' creative ability""]",['Hatha yoga intervention'],"['divergent thinking', 'individual creativity']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]",92.0,0.0286741,There is no effect on convergent thinking.,"[{'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Bollimbala', 'Affiliation': 'Manipal Academy of Higher Education, Manipal, Karnataka, 576104, India; T A Pai Management Institute, Manipal, Karnataka, 576104, India. Electronic address: ashish@tapmi.edu.in.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'James', 'Affiliation': 'IFIM Business School, Bangalore, Karnataka, India.'}, {'ForeName': 'Shirshendu', 'Initials': 'S', 'LastName': 'Ganguli', 'Affiliation': 'T A Pai Management Institute, Manipal, Karnataka, 576104, India. Electronic address: shirshenduganguli@tapmi.edu.in.'}]",Acta psychologica,['10.1016/j.actpsy.2020.103121']
1667,32690074,Efficacy of local budesonide therapy in the management of persistent hyposmia in COVID-19 patients without signs of severity: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


To assess the efficacy of local intranasal treatment with budesonide (nasal irrigation), in addition to olfactory rehabilitation, in the management of loss of smell in COVID-19 patients without signs of severity and with persistent hyposmia 30 days after the onset of symptoms. To search for an association between the presence of an obstruction on MRI and the severity of olfactory loss, at inclusion and after 30 days of treatment.
TRIAL DESIGN


Two center, open-label, 2-arm (1:1 ratio) parallel group randomized controlled superiority trial.
PARTICIPANTS


Inclusion criteria - Patient over 18 years of age; - Patient with a suspected SARS-CoV-2 infection, whether or not confirmed by PCR, or close contact with a PCR-confirmed case, typical chest CT scan (unsystematic frosted glass patches with predominantly sub-pleural appearance, and at a later stage, alveolar condensation without excavation or nodules or masses) or positive serology ; - Patient with isolated sudden onset hyposmia persisting 30 days after the onset of symptoms of CoV-2 SARS infection; - Affiliate or beneficiary of a social security scheme; - Written consent to participate in the study. Non-inclusion criteria - Known hypersensitivity to budesonide or any of the excipients; - Hemostasis disorder or epistaxis; - Oral-nasal and ophthalmic herpes virus infection; - Long-term corticosteroid treatment; - Treatment with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors); - Severe forms of SARS-CoV-2 with respiratory or other signs; - Hyposmia persisting for more than 90 days after the onset of symptoms - Other causes of hyposmia found on interrogation or MRI; - Patient benefiting from a legal protection measure; - Pregnant or breastfeeding women. The participants will be recruited from: Hôpital Fondation Adolphe de Rothschild and Hôpital Lariboisière in Paris, France INTERVENTION AND COMPARATOR: Intervention: Experimental group: Nasal irrigation with budesonide and physiological saline (Budesonide 1mg/2mL diluted in 250mL of physiological saline 9°/00): 3 syringes of 20mL in each nasal cavity, morning and evening, for 30 days, in addition to olfactory rehabilitation twice a day.
CONTROL GROUP


Nasal irrigation with physiological saline 9°/00 only: 3 syringes of 20cc in each nasal cavity, morning and evening, for 30 days, in addition to olfactory rehabilitation twice a day.
MAIN OUTCOMES


Percentage of patients with an improvement of more than 2 points on the ODORATEST score after 30 days of treatment.
RANDOMISATION


Patients will be randomized (1:1) between the experimental and control groups, using the e-CRF. The randomization list will be stratified by centre.
BLINDING (MASKING)


Participants and caregivers are aware of the group assignment. People assessing the outcomes are blinded to the group assignment Numbers to be randomised (sample size) 120 patients are planned to be randomized into two groups of 60 patients.
TRIAL STATUS


MDL_2020_10. Version number 2, May 22, 2020. Recruitment started on May 22, 2020. The trial will finish recruiting by August 2020.
TRIAL REGISTRATION


EUDRACT number: 2020-001667-85; date of trial registration: 15 May 2020 Protocol registered on ClinicalTrial.gov, registration number: NCT04361474 ; date of trial registration: 24 April 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"CONTROL GROUP


","['COVID-19 patients without signs of severity', ' Severe forms of SARS-CoV-2 with respiratory or other signs; - Hyposmia persisting for more than 90 days after the onset of symptoms - Other causes of hyposmia found on interrogation or MRI; - Patient benefiting from a legal protection measure; - Pregnant or breastfeeding women', 'COVID-19 patients without signs of severity and with persistent hyposmia 30 days after the onset of symptoms', 'Two center, open-label, 2-arm (1:1 ratio', 'participants will be recruited from: Hôpital Fondation Adolphe de Rothschild and Hôpital Lariboisière in Paris, France INTERVENTION AND COMPARATOR', 'Inclusion criteria - Patient over 18 years of age; - Patient with a suspected SARS-CoV-2 infection, whether or not confirmed by PCR, or close contact with a PCR-confirmed case, typical chest CT scan (unsystematic frosted glass patches with predominantly sub-pleural appearance, and at a later stage, alveolar condensation without excavation or nodules or masses) or positive serology ; - Patient with isolated sudden onset hyposmia persisting 30 days after the onset of symptoms of CoV-2 SARS infection; - Affiliate or beneficiary of a social security scheme; - Written consent to participate in the study. Non-inclusion criteria - Known hypersensitivity to budesonide or any of the excipients; - Hemostasis disorder or epistaxis; - Oral-nasal and ophthalmic herpes virus infection; - Long-term corticosteroid treatment; - Treatment with']","['Nasal irrigation with physiological saline', 'local budesonide therapy', 'potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone and HIV protease inhibitors', 'budesonide (nasal irrigation', 'Intervention', 'GROUP', 'budesonide and physiological saline (Budesonide']",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2364082', 'cui_str': 'Sense of smell impaired'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030561', 'cui_str': 'Paris'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0521094', 'cui_str': 'Not confirmed by'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0233656', 'cui_str': 'Mental condensation'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0242089', 'cui_str': 'Serology positive'}, {'cui': 'C1272517', 'cui_str': 'Sudden onset'}, {'cui': 'C0037435', 'cui_str': 'Social Insurance'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0015237', 'cui_str': 'Pharmaceutical excipient'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2350442', 'cui_str': 'Nasal irrigation'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3850053', 'cui_str': 'CYP3A4 Inhibitors'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0936148', 'cui_str': 'posaconazole'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0907410', 'cui_str': 'telithromycin'}, {'cui': 'C0068485', 'cui_str': 'nefazodone'}, {'cui': 'C0162714', 'cui_str': 'HIV Protease Inhibitors'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],,0.347084,"CONTROL GROUP


","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Daval', 'Affiliation': 'Hopital Fondation Adolphe de Rothschild, Paris, France. mdaval@for.paris.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Corré', 'Affiliation': 'Hopital Fondation Adolphe de Rothschild, Paris, France.'}, {'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Palpacuer', 'Affiliation': 'Hopital Fondation Adolphe de Rothschild, Paris, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Housset', 'Affiliation': 'Hopital Lariboisiere, Paris, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Poillon', 'Affiliation': 'Hopital Fondation Adolphe de Rothschild, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eliezer', 'Affiliation': 'Hopital Lariboisiere, Paris, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Verillaud', 'Affiliation': 'Hopital Lariboisiere, Paris, France.'}, {'ForeName': 'Dorsaf', 'Initials': 'D', 'LastName': 'Slama', 'Affiliation': 'Hotel Dieu Hospital, Paris, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Ayache', 'Affiliation': 'Hopital Fondation Adolphe de Rothschild, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Herman', 'Affiliation': 'Hopital Lariboisiere, Paris, France.'}, {'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Jourdaine', 'Affiliation': 'Hopital Lariboisiere, Paris, France.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Hervé', 'Affiliation': 'Hopital Fondation Adolphe de Rothschild, Paris, France.'}, {'ForeName': 'Wissame', 'Initials': 'W', 'LastName': 'El Bakkouri', 'Affiliation': 'Hopital Fondation Adolphe de Rothschild, Paris, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Salmon', 'Affiliation': 'Hopital Fondation Adolphe de Rothschild, Paris, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hautefort', 'Affiliation': 'Hopital Lariboisiere, Paris, France.'}]",Trials,['10.1186/s13063-020-04585-8']
1668,32693009,Physical exercise interventions have no effect on serum BDNF concentration in older adults living in long-term nursing homes.,"Physical exercise protects against age-related cognitive decline. Brain-derived neurotrophic factor (BDNF) may mediate some of the cognitive benefits of physical exercise, but the effect of physical exercise on serum BDNF is unclear. Indeed, differential findings have been reported depending on the characteristics of the participants and the intensity, duration, and type of exercise. The aim of this study was to determine whether three different physical exercise interventions alter serum BDNF levels in older adults living in long-term nursing homes (LTNHs) and whether changes in physical, cognitive, and dual-task performance are related to changes in serum BDNF. LTNH study participants (n = 126) were randomly assigned to multicomponent or dual-task training or a walking program and serum BDNF levels were analyzed by ELISA. We also assessed physical, cognitive, and dual-task parameters. Neither the multicomponent, dual-task, nor walking exercise programs caused changes in serum BDNF concentration in older adults living in LTNHs. Changes in BDNF during the interventions were not significantly associated with modifications in physical, cognitive or dual-task performance parameters. Our results provide new evidence clarifying the relationship between physical and cognitive exercise and BDNF.",2020,"Neither the multicomponent, dual-task, nor walking exercise programs caused changes in serum BDNF concentration in older adults living in LTNHs.","['older adults living in long-term nursing homes (LTNHs', 'older adults living in LTNHs', 'LTNH study participants (n\u202f=\u202f126', 'older adults living in long-term nursing homes']","['physical exercise interventions', 'multicomponent or dual-task training or a walking program and serum BDNF levels were analyzed by ELISA', 'Physical exercise', 'multicomponent, dual-task, nor walking exercise programs', 'Physical exercise interventions']","['physical, cognitive, and dual-task parameters', 'physical, cognitive or dual-task performance parameters', 'serum BDNF levels', 'serum BDNF concentration']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",126.0,0.0209679,"Neither the multicomponent, dual-task, nor walking exercise programs caused changes in serum BDNF concentration in older adults living in LTNHs.","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Rezola-Pardo', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: chloe.rezola@ehu.eus.'}, {'ForeName': 'Gotzone', 'Initials': 'G', 'LastName': 'Hervás', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: gotzone.hervas@ehu.eus.'}, {'ForeName': 'Haritz', 'Initials': 'H', 'LastName': 'Arrieta', 'Affiliation': 'Department of Nursing II, Faculty of Medicine and Nursery, University of the Basque Country (UPV/EHU), Paseo Dr. J. Beguiristain, 105, Donostia/San Sebastian 20014, Gipuzkoa, Spain; Onkologikoa Foundation, Paseo Doctor Beguiristain, 121, Donostia/San Sebastián 20014, Gipuzkoa, Spain. Electronic address: haritz.arrieta@ehu.eus.'}, {'ForeName': 'Alejandra', 'Initials': 'A', 'LastName': 'Hernández-de Diego', 'Affiliation': 'Zorroaga Foundation, Alto Zorroaga, 1, Donostia/San Sebastian 20014, Gipuzkoa, Spain. Electronic address: s.hernandez@zorroaga.eus.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Ruiz-Litago', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: fatima.ruiz@ehu.eus.'}, {'ForeName': 'Susana Maria', 'Initials': 'SM', 'LastName': 'Gil', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: susana.gil@ehu.eus.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Rodriguez-Larrad', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: ana.rodriguez@ehu.eus.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Irazusta', 'Affiliation': 'Department of Physiology, Faculty of Medicine and Nursery, University of the Basque Country, Bo Sarriena s/n, Leioa 48940, Bizkaia, Spain. Electronic address: jon.irazusta@ehu.eus.'}]",Experimental gerontology,['10.1016/j.exger.2020.111024']
1669,32693104,Early Antibiotic Therapy and Adverse Outcomes in Preterm Infants: Time for a Trial!,,2020,,['preterm infants'],[],[],"[{'cui': 'C0021294', 'cui_str': 'Premature infant'}]",[],[],,0.0647176,,"[{'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Cantey', 'Affiliation': 'Department of Pediatrics, Divisions of Neonatology and Pediatric Infectious Diseases, University of Texas Health San Antonio, San Antonio, Texas. Electronic address: cantey@uthscsa.edu.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.07.046']
1670,32698151,The role of IL-1 in the regulation of copeptin in patients with metabolic syndrome.,"Arginine vasopressin (AVP) was suggested to contribute to cardiovascular risk and type 2 diabetes in patients with metabolic syndrome. The proinflammatory cytokine interleukin (IL)-1 is able to induce AVP secretion and plays a causal role in cardiovascular mortality and type 2 diabetes. We investigated in two studies whether copeptin levels - the surrogate marker for AVP - are regulated by IL-1-mediated chronic inflammation in patients with metabolic syndrome. Study A was a prospective, interventional, single-arm study (2014-2016). Study B was a randomized, placebo-controlled, double-blind study (2016-2017). n = 73 (Study A) and n = 66 (Study B) adult patients with metabolic syndrome were treated with 100 mg anakinra or placebo (only in study B) twice daily for 1 day (study A) and 28 days (study B). Fasting blood samples were drawn at day 1, 7, and 28 of treatment for measurement of serum copeptin. Patients with chronic low-grade inflammation (C-reactive protein levels ≥2 mg/L) and BMI >35 kg/m2 had higher baseline copeptin levels (7.7 (IQR 4.9-11.9) vs 5.8 (IQR 3.9-9.3) pmol/L, Pinflamm = 0.009; 7.8 (IQR 5.4-11.7) vs 4.9 (IQR 3.7-9.8) pmol/L, PBMI = 0.008). Copeptin levels did not change either in the anakinra or in the placebo group and remained stable throughout the treatment (P = 0.44). Subgroup analyses did not reveal effect modifications. Therefore, we conclude that, although IL-1-mediated inflammation is associated with increased circulating copeptin levels, antagonizing IL-1 does not significantly alter copeptin levels in patients with metabolic syndrome.",2020,Copeptin levels did not change neither in the anakinra nor in the placebo group and remained stable throughout the treatment (p=0.44).,"['patients with metabolic syndrome', 'n=73 (Study A) and', 'Patients with chronic low-grade inflammation (C-reactive protein levels ≥2', 'n=66 (Study B) adult patients with metabolic syndrome']","['Arginine vasopressin (AVP', '100 mg anakinra or placebo', 'placebo']","['Copeptin levels', 'Fasting blood samples', 'baseline copeptin levels', 'copeptin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0056279', 'cui_str': 'copeptins'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.131798,Copeptin levels did not change neither in the anakinra nor in the placebo group and remained stable throughout the treatment (p=0.44).,"[{'ForeName': 'Milica', 'Initials': 'M', 'LastName': 'Popovic', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Fahim', 'Initials': 'F', 'LastName': 'Ebrahimi', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Sandrine Andrea', 'Initials': 'SA', 'LastName': 'Urwyler', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Marc Yves', 'Initials': 'MY', 'LastName': 'Donath', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Christ-Crain', 'Affiliation': 'Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.'}]",Endocrine connections,['10.1530/EC-20-0197']
1671,32698159,"Effect of conjugated estrogens and bazedoxifene on glucose, energy and lipid metabolism in obese postmenopausal women.","Objective


Combining conjugated estrogens (CE) with the selective estrogen receptor modulator bazedoxifene (BZA) is a novel, orally administered menopausal therapy. We investigated the effect of CE/BZA on insulin sensitivity, energy metabolism, and serum metabolome in postmenopausal women with obesity.
Design


Randomized, double-blind, crossover pilot trial with washout was conducted at Pennington Biomedical Research Center. Eight postmenopausal women (age 50-60 years, BMI 30-40 kg/m2) were randomized to 8 weeks CE/BZA or placebo. Primary outcome was insulin sensitivity (hyperinsulinemic-euglycemic clamp). Secondary outcomes included body composition (DXA); resting metabolic rate (RMR); substrate oxidation (indirect calorimetry); ectopic lipids (1H-MRS); fat cell size, adipose and skeletal muscle gene expression (biopsies); serum inflammatory markers; and serum metabolome (LC/MS).
Results


CE/BZA treatment produced no detectable effect on insulin sensitivity, body composition, ectopic fat, fat cell size, or substrate oxidation, but resulted in a non-significant increase in RMR (basal: P = 0.06; high-dose clamp: P = 0.08) compared to placebo. CE/BZA increased serum high-density lipoprotein (HDL)-cholesterol. CE/BZA also increased serum diacylglycerol (DAG) and triacylglycerol (TAG) species containing long-chain saturated, mono- and polyunsaturated fatty acids (FAs) and decreased long-chain acylcarnitines, possibly reflecting increased hepatic de novo FA synthesis and esterification into TAGs for export into very low-density lipoproteins, as well as decreased FA oxidation, respectively (P < 0.05). CE/BZA increased serum phosphatidylcholines, phosphatidylethanolamines, ceramides, and sphingomyelins, possibly reflecting the increase in serum lipoproteins (P < 0.05).
Conclusions


A short treatment of obese postmenopausal women with CE/BZA does not alter insulin action or ectopic fat but increases serum markers of hepatic de novo lipogenesis and TAG production.",2020,"RESULTS


CE/BZA treatment produced no detectable effect on insulin sensitivity, body composition, ectopic fat, fat cell size, or substrate oxidation, but resulted in a non-significant increase in RMR (basal: p=0.06; high-dose clamp: p=0.08) compared to placebo.","['obese postmenopausal women', 'postmenopausal women with obesity', 'Eight postmenopausal women (age 50-60 y, BMI 30-40 kg/m2', 'obese postmenopausal women with']","['CE/BZA or placebo', 'conjugated estrogens (CE) with the selective estrogen receptor modulator bazedoxifene (BZA', 'CE/BZA', 'conjugated estrogens and bazedoxifene', 'placebo']","['serum phosphatidylcholines, phosphatidylethanolamines, ceramides, and sphingomyelins, possibly reflecting the increase in serum lipoproteins (p<0.05', 'RMR', 'glucose, energy and lipid metabolism', 'body composition (DXA); resting metabolic rate (RMR); substrate oxidation (indirect calorimetry); ectopic lipids (1H-MRS); fat cell size, adipose and skeletal muscle gene expression (biopsies); serum inflammatory markers; and serum metabolome (LC/MS', 'insulin sensitivity (hyperinsulinemic-euglycemic clamp', 'insulin sensitivity, body composition, ectopic fat, fat cell size, or substrate oxidation', 'serum high-density lipoprotein (HDL)-cholesterol', 'insulin sensitivity, energy metabolism, and serum metabolome', 'serum diacylglycerol (DAG) and triacylglycerol']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0014938', 'cui_str': 'Estrogens, Conjugated (USP)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0732611', 'cui_str': 'Selective estrogen receptor modulator'}, {'cui': 'C2346970', 'cui_str': 'bazedoxifene'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1959616', 'cui_str': 'Lecithin'}, {'cui': 'C0031618', 'cui_str': 'Phosphatidylethanolamines'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0037906', 'cui_str': 'Sphingomyelin'}, {'cui': 'C2362652', 'cui_str': 'Possible diagnosis'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0006781', 'cui_str': 'Indirect calorimetry'}, {'cui': 'C0340464', 'cui_str': 'Ectopic beats'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0206131', 'cui_str': 'Adipocyte'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0012262', 'cui_str': 'Diacylglycerols'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.199062,"RESULTS


CE/BZA treatment produced no detectable effect on insulin sensitivity, body composition, ectopic fat, fat cell size, or substrate oxidation, but resulted in a non-significant increase in RMR (basal: p=0.06; high-dose clamp: p=0.08) compared to placebo.","[{'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Marlatt', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Dragana', 'Initials': 'D', 'LastName': 'Lovre', 'Affiliation': 'Tulane University Health Sciences Center, New Orleans, Louisiana, USA.'}, {'ForeName': 'Robbie A', 'Initials': 'RA', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Chandra R', 'Initials': 'CR', 'LastName': 'Tate', 'Affiliation': 'Tulane University Health Sciences Center, New Orleans, Louisiana, USA.'}, {'ForeName': 'Evelyn K', 'Initials': 'EK', 'LastName': 'Hayes', 'Affiliation': 'Baton Rouge General Hospital, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Burant', 'Affiliation': 'Departments of Internal Medicine, Molecular and Integrative Physiology, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ravussin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Mauvais-Jarvis', 'Affiliation': 'Tulane University Health Sciences Center, New Orleans, Louisiana, USA.'}]",European journal of endocrinology,['10.1530/EJE-20-0619']
1672,32700114,The effectiveness and cost-effectiveness of an integrated osteoporosis care programme for postmenopausal women in Flanders: study protocol of a quasi-experimental controlled design.,"Osteoporosis causes high individual and societal burden, due to limited attention to fracture prevention. Integrated care for chronic conditions has shown to facilitate management of these conditions, improving clinical outcomes alongside quality of life and cost-effectiveness. This manuscript describes an integrated osteoporosis care programme that will be implemented in primary care.
OBJECTIVE


To provide a comprehensive description of a quasi-experimental study design in which a newly developed integrated osteoporosis care (IOC) programme for the management of postmenopausal osteoporosis (PO) in primary care (PC) is implemented and will be compared with care as usual (CAU).
METHODS


A literature research was performed and expert meetings have been taking place, which has led to the development of a complex PC intervention based on framework for integrated people-centred health services (IPCHS).
RESULTS


This manuscript describes the developmental process of the preclinical phase of a quasi-experimental real-world design and the interventions as a result of this process that will be implemented during the clinical phase, along with the evaluation that will take place alongside the clinical phase: An integrative approach for the management of PO in primary care was developed and will be implemented in greater region of Ghent (GRG), Belgium. The approach consists of a complex intervention targeting patients and PC stakeholders in osteoporosis care (e.g. general practitioners (GPs), physiotherapists, nurses, pharmacists). A comparison will be made with CAU using medication possession ratios (MPR) of included patients as primary outcome. These data will be obtained from the national health database. Secondary outcomes are physician outcomes, patient-reported outcome measures (PROMs), and patient-reported experience measures (PREMs). A cost-effectiveness evaluation will be performed if the programme appears to be effective in terms of MPR.
TRIAL REGISTRATION


ClinicalTrials.gov : NCT03970902.",2020,"Integrated care for chronic conditions has shown to facilitate management of these conditions, improving clinical outcomes alongside quality of life and cost-effectiveness.","['patients and PC stakeholders in osteoporosis care (e.g. general practitioners (GPs), physiotherapists, nurses, pharmacists', 'postmenopausal osteoporosis (PO) in primary care (PC', 'postmenopausal women in Flanders']","['complex intervention targeting', 'integrated osteoporosis care programme', 'integrated osteoporosis care (IOC) programme']","['effectiveness and cost-effectiveness', 'physician outcomes, patient-reported outcome measures (PROMs), and patient-reported experience measures (PREMs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1875156', 'cui_str': 'Flanders'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0446341,"Integrated care for chronic conditions has shown to facilitate management of these conditions, improving clinical outcomes alongside quality of life and cost-effectiveness.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Verdonck', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University, Ghent, Belgium. caroline.verdonck@ugent.be.'}, {'ForeName': 'Lieven', 'Initials': 'L', 'LastName': 'Annemans', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Goemaere', 'Affiliation': 'Department of Endocrinology and Rheumatology, Unit Osteoporosis and Metabolic Bone Disease, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Lapauw', 'Affiliation': 'Department of Endocrinology and Rheumatology, Unit Osteoporosis and Metabolic Bone Disease, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Goderis', 'Affiliation': 'Academic Centre for General practice, Department of Public Health and Primary Care, KU Leuven - University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Balligand', 'Affiliation': ', Beringen, Belgium.'}, {'ForeName': 'Marie-Paule', 'Initials': 'MP', 'LastName': 'Doom', 'Affiliation': ', Beringen, Belgium.'}, {'ForeName': 'Stany', 'Initials': 'S', 'LastName': 'Perkisas', 'Affiliation': 'University Centre Geriatrics, University Hospital Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Borgermans', 'Affiliation': 'Department of Public Health and Primary Care, Ghent University, Ghent, Belgium.'}]",Archives of osteoporosis,['10.1007/s11657-020-00776-7']
1673,32703746,The effects of switching from 10 to 5-dose vials of MR vaccine on vaccination coverage and wastage: A mixed-method study in Zambia.,"INTRODUCTION


Vaccines procured for low-income countries are often packaged in multi-dose vials to reduce program costs. To avoid wastage, health workers may refrain from opening a vial if few children attend an immunization session, possibly leading to lower coverage. Lowering the number of doses in a vial may increase coverage and reduce wastage.
METHODS


We used a mixed methods approach to measure the effects of switching from conventional 10-dose measles containing vaccine (MCV) vials to 5-dose MCV vials on coverage and open vial wastage in 14 districts purposely selected from two provinces in Zambia. The districts were paired based on the number of health facilities and the average size of the health facility catchment population. One district from each pair was randomly allocated to receive 5-dose vials while the other continued with the conventional vials. We applied propensity score matched difference-in-difference analysis to estimate intervention effects on coverage using pre-intervention household survey and post-intervention household survey after 11 months of the intervention. The intervention effects on wastage rates were estimated from multivariate analysis of the administrative data. Key informant interviews were conducted to better understand health workers' behavior and preferences at baseline, midline and endline, and analyzed using thematic analysis techniques.
RESULTS


MCV coverage rates increased across both arms for both doses. A five percentage-point intervention effect was detected for MCV1 and 3.5 percentage-point effect for MCV2. The MCV wastage rate was 47% lower in facilities using 5-dose vials (16.2%) versus 10-dose vials (30.5%). Healthcare workers reported being more willing to open a 5-dose vial than a 10-dose vial for one child, as they were less concerned about wastage.
DISCUSSION


Switching 10-dose MCV vials to 5-dose vials improved coverage, decreased wastage, and improved willingness to open a vial. These findings can contribute to strategies for reducing missed opportunities for vaccination.",2020,The MCV wastage rate was 47% lower in facilities using 5-dose vials (16.2%) versus 10-dose vials (30.5%).,"['14 districts purposely selected from two provinces in Zambia', 'Zambia']",['MR vaccine'],"['wastage rates', 'vaccination coverage and wastage', 'MCV wastage rate', 'MCV coverage rates', 'coverage and reduce wastage']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C4505148', 'cui_str': 'Vaccination Coverage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",,0.0316677,The MCV wastage rate was 47% lower in facilities using 5-dose vials (16.2%) versus 10-dose vials (30.5%).,"[{'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Krudwig', 'Affiliation': 'John Snow, Inc, United States.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Knittel', 'Affiliation': 'John Snow, Inc, United States.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Karim', 'Affiliation': 'John Snow, Inc, United States.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Kanagat', 'Affiliation': 'John Snow, Inc, United States.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Prosser', 'Affiliation': 'John Snow, Inc, United States. Electronic address: wendy_prosser@jsi.com.'}, {'ForeName': 'Guissimon', 'Initials': 'G', 'LastName': 'Phiri', 'Affiliation': 'Ministry of Health, Zambia, Immunization Program, Zambia.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Mwansa', 'Affiliation': 'Ministry of Health, Zambia, Immunization Program, Zambia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Steinglass', 'Affiliation': 'John Snow, Inc, United States.'}]",Vaccine,['10.1016/j.vaccine.2020.07.012']
1674,32705205,Protective effect of bromfenac sodium on femtosecond laser‑assisted cataract surgery via modulating cyclooxygenase‑2 expression.,"Cataract is a blinding‑caused disease and affects millions of individuals worldwide. Although conventional phacoemulsification (CPCS) has been widely used for treatment of cataract, the incidence of cataract‑caused blindness still increased year by year. Recently, femtosecond laser technology has been expanded to variety of clinical applications, including cataract surgery. The present study evaluated the curative effect of bromfenac sodium (BS) after femtosecond laser‑assisted cataract surgery (FLACS) and analyzed the mechanism of action. A total of 90 patients were randomly divided into five groups: Group I, conventional phacoemulsification treatment (CPCS) + dexamethasone (DEX)/tobramycin (TOB); group II, CPCS + bromfenac sodium (BS); group III, Femtosecond laser‑assisted cataract surgery (FLACS) + DEX/TOB; group IV, FLACS + BS; and group V, FLACS + pranoprofen. Aqueous humor was collected from these patients post‑surgery. For in vitro studies, SRA01/04 cells were irradiated using UV, followed by the collection of culture media and cell lysate. Prostaglandin E2 (PGE2) levels, an indicator of inflammation, were measured using ELISA both in vivo and in vitro. In addition, cyclooxygenase (COX) and cleaved caspase‑1 p20 expression levels were analyzed using western blotting. The findings suggested that BS was more effective and safer compared with glucocorticoids (GCs) after cataract surgery. BS can protect against post‑operative inflammation by inhibiting PGE2 production. Under in vitro conditions BS prevented the SRA01/04 cells from undergoing apoptosis after UV treatment and also suppressed PGE2 release from UV‑irradiated SRA01/04 cells by modulating COX‑2 expression. Furthermore, BS may have an inhibitory effect on the inflammatory form of cell death. Overall, these results indicated that BS could replace existing GCs as a reliable drug for a perioperative period of cataract surgery. It was also identified that the inhibitory effect of BS on PGE2 production was mediated via the regulation of COX‑2.",2020,Under in vitro conditions BS prevented the SRA01/04 cells from undergoing apoptosis after UV treatment and also suppressed PGE2 release from UV‑irradiated SRA01/04 cells by modulating COX‑2 expression.,['A total of 90\xa0patients'],"['bromfenac sodium', 'conventional phacoemulsification treatment (CPCS) + dexamethasone (DEX)/tobramycin (TOB); group\xa0II, CPCS + bromfenac sodium (BS); group\xa0III, Femtosecond laser‑assisted cataract surgery (FLACS)\xa0+ DEX/TOB; group\xa0IV, FLACS + BS; and group\xa0V, FLACS\xa0+ pranoprofen', 'glucocorticoids (GCs', 'bromfenac sodium (BS', 'femtosecond laser technology', 'conventional phacoemulsification (CPCS', 'femtosecond laser‑assisted cataract surgery (FLACS', 'cyclooxygenase (COX']","['Prostaglandin\xa0E2 (PGE2) levels, an indicator of inflammation']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0107211', 'cui_str': 'Bromfenac sodium'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C1276848', 'cui_str': 'Dexamethasone- and tobramycin-containing product'}, {'cui': 'C0441855', 'cui_str': 'Group V'}, {'cui': 'C0072652', 'cui_str': 'pranoprofen'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}]","[{'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.0145938,Under in vitro conditions BS prevented the SRA01/04 cells from undergoing apoptosis after UV treatment and also suppressed PGE2 release from UV‑irradiated SRA01/04 cells by modulating COX‑2 expression.,"[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Department of Ophthalmology, The Fourth Affiliated Hospital of China Medical University, Shenyang, Liaoning 110059, P.R. China.'}, {'ForeName': 'Jiangyue', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Ophthalmology, The Fourth Affiliated Hospital of China Medical University, Shenyang, Liaoning 110059, P.R. China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, The Fourth Affiliated Hospital of China Medical University, Shenyang, Liaoning 110059, P.R. China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Department of Ophthalmology, The Fourth Affiliated Hospital of China Medical University, Shenyang, Liaoning 110059, P.R. China.'}, {'ForeName': 'Jingsong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, The Fourth Affiliated Hospital of China Medical University, Shenyang, Liaoning 110059, P.R. China.'}]",Molecular medicine reports,['10.3892/mmr.2020.11311']
1675,32701512,Pharmacogenomics of aromatase inhibitors in postmenopausal breast cancer and additional mechanisms of anastrozole action.,"Aromatase inhibitors (AIs) reduce breast cancer recurrence and prolong survival, but up to 30% of patients exhibit recurrence. Using a genome-wide association study of patients entered on MA.27, a phase III randomized trial of anastrozole versus exemestane, we identified a single nucleotide polymorphism (SNP) in CUB And Sushi multiple domains 1 (CSMD1) associated with breast cancer-free interval, with the variant allele associated with fewer distant recurrences. Mechanistically, CSMD1 regulates CYP19 expression in an SNP- and drug-dependent fashion, and this regulation is different among 3 AIs: anastrozole, exemestane, and letrozole. Overexpression of CSMD1 sensitized AI-resistant cells to anastrozole but not to the other 2 AIs. The SNP in CSMD1 that was associated with increased CSMD1 and CYP19 expression levels increased anastrozole sensitivity, but not letrozole or exemestane sensitivity. Anastrozole degrades estrogen receptor α (ERα), especially in the presence of estradiol (E2). ER+ breast cancer organoids and AI- or fulvestrant-resistant breast cancer cells were more sensitive to anastrozole plus E2 than to AI alone. Our findings suggest that the CSMD1 SNP might help to predict AI response, and anastrozole plus E2 serves as a potential new therapeutic strategy for patients with AI- or fulvestrant-resistant breast cancers.",2020,ER positive breast cancer organoids and AI- or fulvestrant-resistant breast cancer cells were more sensitive to anastrozole plus E2 than to AI alone.,"['postmenopausal breast cancer', 'patients with AI- or fulvestrant-resistant breast cancers']","['CSMD1 SNP', 'anastrozole', 'anastrozole, exemestane, and letrozole', 'anastrozole vs exemestane', 'Anastrozole', 'aromatase inhibitors']","['Aromatase inhibitors (AIs) reduce breast cancer recurrence and prolong survival', 'CSMD1 and CYP19 expression levels increased anastrozole sensitivity']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}]","[{'cui': 'C0010435', 'cui_str': 'Cuba'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}]","[{'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0010435', 'cui_str': 'Cuba'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0003805', 'cui_str': 'Androstenedione Aromatase'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0290883', 'cui_str': 'anastrozole'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0242212,ER positive breast cancer organoids and AI- or fulvestrant-resistant breast cancer cells were more sensitive to anastrozole plus E2 than to AI alone.,"[{'ForeName': 'Junmei', 'Initials': 'J', 'LastName': 'Cairns', 'Affiliation': 'Department of Molecular Pharmacology and Experimental Therapeutics.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Ingle', 'Affiliation': 'Division of Medical Oncology, and.'}, {'ForeName': 'Tanda M', 'Initials': 'TM', 'LastName': 'Dudenkov', 'Affiliation': 'Department of Molecular Pharmacology and Experimental Therapeutics.'}, {'ForeName': 'Krishna R', 'Initials': 'KR', 'LastName': 'Kalari', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Carlson', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Na', 'Affiliation': 'Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Aman U', 'Initials': 'AU', 'LastName': 'Buzdar', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Robson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Ellis', 'Affiliation': 'Baylor Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Goss', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Lois E', 'Initials': 'LE', 'LastName': 'Shepherd', 'Affiliation': 'NCIC Clinical Trials Group, Kingston, Ontario, Canada.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Goodnature', 'Affiliation': 'Patient advocate, Mayo Clinic Breast Cancer Specialized Program of Research Excellence, Rochester, Minnesota, USA.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Goetz', 'Affiliation': 'Division of Medical Oncology, and.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Weinshilboum', 'Affiliation': 'Department of Molecular Pharmacology and Experimental Therapeutics.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Molecular Pharmacology and Experimental Therapeutics.'}, {'ForeName': 'Mehrab Ghanat', 'Initials': 'MG', 'LastName': 'Bari', 'Affiliation': 'Department of Molecular Pharmacology and Experimental Therapeutics.'}, {'ForeName': 'Liewei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Molecular Pharmacology and Experimental Therapeutics.'}]",JCI insight,['10.1172/jci.insight.137571']
1676,32701597,Pharmacologic and psychological interventions for depression treatment in patients with kidney disease.,"PURPOSE OF REVIEW


It remains controversial whether existing therapies, including pharmacologic and psychological interventions, are effective for treatment of depression in patients with chronic kidney disease (CKD) and end-stage kidney disease.
RECENT FINDINGS


Most studies of depression treatment were underpowered or uncontrolled. The CKD Antidepressant Sertraline Trial showed no benefit of a serotonin-selective reuptake inhibitor (SSRI), sertraline, over double-blind matched placebo for the treatment of depressive symptoms in patients with nondialysis CKD. A Trial of Sertraline vs. Cognitive Behavioral Therapy (CBT) for End-stage Renal Disease Patients with Depression showed improvement in depressive symptoms from baseline in both groups and a marginal benefit of sertraline over CBT that was of unclear clinical significance, given the lack of an active control group. SSRIs are associated with poor tolerability in clinical trials and serious adverse outcomes in large retrospective studies.
SUMMARY


Although the data do not support unlimited use of SSRIs in patients with CKD or end-stage kidney disease, it is reasonable to initiate a cautious trial of sertraline while closely monitoring for depressive symptom improvement and adverse effects. CBT is a low-risk, possibly effective intervention to treat major depressive disorder in patients with kidney disease who have access to such treatments.",2020,"The CKD Antidepressant Sertraline Trial showed no benefit of a serotonin-selective reuptake inhibitor (SSRI), sertraline, over double-blind matched placebo for the treatment of depressive symptoms in patients with nondialysis CKD.","['patients with kidney disease', 'patients with nondialysis CKD', 'patients with CKD or end-stage kidney disease', 'patients with kidney disease who have access to such treatments', 'patients with chronic kidney disease (CKD) and end-stage kidney disease']","['serotonin-selective reuptake inhibitor (SSRI), sertraline', 'CBT', 'Pharmacologic and psychological interventions', 'Sertraline vs. Cognitive Behavioral Therapy (CBT', 'placebo']",['depressive symptoms'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0565791,"The CKD Antidepressant Sertraline Trial showed no benefit of a serotonin-selective reuptake inhibitor (SSRI), sertraline, over double-blind matched placebo for the treatment of depressive symptoms in patients with nondialysis CKD.","[{'ForeName': 'L Parker', 'Initials': 'LP', 'LastName': 'Gregg', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Texas Southwestern Medical Center.'}, {'ForeName': 'S Susan', 'Initials': 'SS', 'LastName': 'Hedayati', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Texas Southwestern Medical Center.'}]",Current opinion in nephrology and hypertension,['10.1097/MNH.0000000000000629']
1677,32710493,"Long-Term Safety and Tolerability of Apremilast Versus Placebo in Psoriatic Arthritis: A Pooled Safety Analysis of Three Phase III, Randomized, Controlled Trials.","OBJECTIVE


Psoriatic arthritis (PsA) requires long-term treatment, yet safety concerns and monitoring requirements make maintenance a challenge. This analysis of pooled Psoriatic Arthritis Long-term Assessment of Clinical Efficacy (PALACE) 1, 2, and 3 data describes 3-year apremilast safety and tolerability in PsA.
METHODS


Patients with active PsA were randomized (1:1:1) to placebo, apremilast 30 mg twice daily, or apremilast 20 mg twice daily. Placebo patients were re-randomized to apremilast 30 mg twice daily or 20 mg twice daily at week 16 (early escape) or 24. Double-blind treatment continued to week 52; patients could continue apremilast during an open-label, long-term treatment phase.
RESULTS


In total, 1493 patients received at least one dose of study medication and were included in the safety population (placebo: n = 495; apremilast 30 mg: n = 497; apremilast 20 mg: n = 501). Among patients receiving apremilast, 53.2% (767/1441) completed 3 years of treatment. Greater rates of adverse events (AEs) were reported with apremilast (61.1%; exposure-adjusted incidence rate [EAIR]/100 patient-years, 265.1) versus placebo (47.5%; EAIR/100 patient-years, 200.7) in the placebo-controlled period. During weeks 0 to ≤52, the most common AEs occurring in apremilast-exposed patients were diarrhea (13.9%; EAIR/100 patient-years, 18.6), nausea (12.3%; EAIR/100 patient-years, 16.0), headache (9.4%; EAIR/100 patient-years, 12.1), upper respiratory tract infection (9.1%; EAIR/100 patient-years, 11.5), and nasopharyngitis (6.2%; EAIR/100 patient-years, 7.7). Most AEs were mild/moderate with apremilast exposure ≤156 weeks. Rates of depression remained low (EAIR/100 patient-years, 1.8). Major adverse cardiac events (EAIR/100 patient-years, 0.5), malignancies (EAIR/100 patient-years, 0.9), and serious opportunistic infections (EAIR/100 patient-years, 0.0) were infrequent over the 3-year exposure period. Discontinuation rates due to AEs were low (<7.5%) across all apremilast-exposure periods. Incidences of clinically meaningful abnormalities in postbaseline laboratory values was low; most values returned to baseline levels with continued treatment and without intervention.
CONCLUSION


Apremilast demonstrated a favorable safety profile and was well tolerated up to 156 weeks.",2020,"Among patients receiving apremilast, 53.2% (767/1441) completed 3 years of treatment.","['Patients with active PsA', '1493 patients received at least one dose of study medication and were included in the safety population ', 'Psoriatic Arthritis', 'patients receiving apremilast, 53.2% (767/1441) completed 3 years of treatment']","['Apremilast Versus Placebo', 'Placebo', 'placebo, apremilast 30 mg twice daily, or apremilast 20 mg twice daily', 'placebo']","['headache', 'diarrhea', 'Rates of depression', 'serious opportunistic infections', 'upper respiratory tract infection', 'nasopharyngitis', 'Greater rates of adverse events (AEs', 'nausea', 'Major adverse cardiac events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1678805', 'cui_str': 'apremilast'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1678805', 'cui_str': 'apremilast'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3819585', 'cui_str': 'apremilast 30 MG [Otezla]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C3819586', 'cui_str': 'apremilast 20 MG [Otezla]'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic infectious disease'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",1493.0,0.225162,"Among patients receiving apremilast, 53.2% (767/1441) completed 3 years of treatment.","[{'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center/Providence St. Joseph Health, Seattle, Washington and University of Washington School of Medicine, Seattle.'}, {'ForeName': 'Dafna D', 'Initials': 'DD', 'LastName': 'Gladman', 'Affiliation': 'Krembil Research Institute, Toronto Western Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Gomez-Reino', 'Affiliation': 'Fundación Dominguez, Hospital Clínico Universitario, Santiago, Spain.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Monash University, Cabrini Health, Melbourne, Australia.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'University of California San Diego School of Medicine, La Jolla.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lespessailles', 'Affiliation': 'Regional Hospital, University of Orléans, Orléans, France.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Schett', 'Affiliation': 'Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany und Universitätsklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Paris', 'Affiliation': 'Amgen Inc, Thousand Oaks, California.'}, {'ForeName': 'Nikolay', 'Initials': 'N', 'LastName': 'Delev', 'Affiliation': 'Celgene Corporation, Summit, New Jersey.'}, {'ForeName': 'Lichen', 'Initials': 'L', 'LastName': 'Teng', 'Affiliation': 'Amgen Inc, Thousand Oaks, California.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Wollenhaupt', 'Affiliation': 'Jürgen Wollenhaupt: Schön Klinik Hamburg Eilbek, Hamburg, Germany.'}]",ACR open rheumatology,['10.1002/acr2.11156']
1678,32706719,A Novel Educational Control Group Mobile App for Meditation Interventions: Single-Group Feasibility Trial.,"BACKGROUND


Smartphone ownership is becoming ubiquitous among US adults, making the delivery of health interventions via a mobile app (ie, mobile health [mHealth]) attractive to many researchers and clinicians. Meditation interventions have become popular and have been delivered to study participants via mobile apps to improve a range of health outcomes in both healthy adults and those with chronic diseases. However, these meditation mHealth interventions have been limited by a lack of high-quality control groups. More specifically, these studies have lacked consistency in their use of active, time-matched, and attention-matched control groups.
OBJECTIVE


The purpose of this study is to beta test a novel health education podcast control condition delivered via a smartphone app that would be a strong comparator to be used in future studies of app-based meditation interventions.
METHODS


Patients with myeloproliferative neoplasm (MPN) cancer were recruited nationally. Upon enrollment, participants were informed to download the investigator-developed health education podcast app onto their mobile phone and listen to ~60 min/week of cancer-related educational podcasts for 12 weeks. The benchmarks for feasibility included ≥70% of participants completing ≥70% of the prescribed 60 min/week of podcasts, ≥70% of participants reporting that they were satisfied with the intervention, and ≥70% of participants reporting that they enjoyed the health education podcasts.
RESULTS


A total of 96 patients with MPN were enrolled in the study; however, 19 never began the intervention. Of the 77 patients who participated in the intervention, 39 completed the entire study (ie, sustained participation through the follow-up period). Participation averaged 103.2 (SD 29.5) min/week. For 83.3% (10/12) of the weeks, at least 70% of participants completed at least 70% of their total prescribed use. Almost half of participants reported that they enjoyed the health education podcasts (19/39, 48.7%) and were satisfied with the intervention (17/39, 43.6%). There were no significant changes in cancer-related outcomes from baseline to postintervention.
CONCLUSIONS


A 12-week, health education podcast mobile app was demanded but not accepted in a sample of patients with cancer. Using the mobile app was not associated with significant changes in cancer-related symptoms. Based on findings from this study, a health education podcast mobile app may be a feasible option as a time- and attention-matched control group for efficacy trials with more extensive formative research for the content of the podcasts and its acceptability by the specific population.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03907774; https://clinicaltrials.gov/ct2/show/NCT03907774.",2020,"There were no significant changes in cancer-related outcomes from baseline to postintervention.
","['77 patients who participated in the intervention, 39 completed the entire study (ie, sustained participation through the follow-up period', 'healthy adults and those with chronic diseases', 'patients with cancer', 'Patients with myeloproliferative neoplasm (MPN) cancer were recruited nationally', '96 patients with MPN were enrolled in the study; however, 19 never began the intervention']","['Educational Control Group Mobile App for Meditation Interventions', 'Meditation interventions']","['health education podcasts', 'cancer-related symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0027022', 'cui_str': 'Myeloproliferative disorder'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C2718063', 'cui_str': 'Podcasts'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",96.0,0.183313,"There were no significant changes in cancer-related outcomes from baseline to postintervention.
","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Huberty', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Eckert', 'Affiliation': 'Mays Cancer Center, University of Texas Health San Antonio MD Anderson, San Antonio, TX, United States.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Puzia', 'Affiliation': 'Behavioral Research and Analytics, LLC, Salt Lake City, UT, United States.'}, {'ForeName': 'Breanne', 'Initials': 'B', 'LastName': 'Laird', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Larkey', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, United States.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Mesa', 'Affiliation': 'Mays Cancer Center, University of Texas Health San Antonio MD Anderson, San Antonio, TX, United States.'}]",JMIR formative research,['10.2196/19364']
1679,32706720,An Internet-Based Cognitive Behavioral Program for Adolescents With Anxiety: Pilot Randomized Controlled Trial.,"BACKGROUND


Internet-based cognitive behavioral therapy (ICBT) is a treatment approach recently developed and studied to provide frontline treatment to adolescents with anxiety disorders.
OBJECTIVE


This study aimed to pilot procedures and obtain data on methodological processes and intervention satisfaction to determine the feasibility of a definitive randomized controlled trial (RCT) to test the effectiveness of a self-managed ICBT program, Breathe (Being Real, Easing Anxiety: Tools Helping Electronically), for adolescents with anxiety concerns.
METHODS


This study employed a two-arm, multisite, pilot RCT. Adolescents aged 13 to 17 years with a self-identified anxiety concern were recruited online from health care settings and school-based mental health care services across Canada between April 2014 and May 2016. We compared 8 weeks of ICBT with ad hoc telephone and email support (Breathe experimental group) to access to a static webpage listing anxiety resources (control group). The primary outcome was the change in self-reported anxiety from baseline to 8 weeks (posttreatment), which was used to determine the sample size for a definitive RCT. Secondary outcomes were recruitment and retention rates, a minimal clinically important difference (MCID) for the primary outcome, intervention acceptability and satisfaction, use of cointerventions, and health care resource use, including a cost-consequence analysis.
RESULTS


Of the 588 adolescents screened, 94 were eligible and enrolled in the study (49 adolescents were allocated to Breathe and 45 were allocated to the control group). Analysis was based on 74% (70/94) of adolescents who completed baseline measures and progressed through the study. Enrolled adolescents were, on average, 15.3 years old (SD 1.2) and female (63/70, 90%). Retention rates at 8 weeks were 28% (13/46; Breathe group) and 58% (24/43; control group). Overall, 39% (14/36) of adolescents provided feedback on completion of the Breathe program. Adolescents' scores on a satisfaction survey indicated a moderate level of satisfaction. All but one adolescent indicated that Breathe was easy to use and they understood all the material presented. The most frequent barrier identified for program completion was difficulty in completing exposure activities. The power analysis indicated that 177 adolescents per group would be needed to detect a medium effect size (d=0.3) between groups in a definitive trial. Data for calculating an MCID or conducting a cost-consequence analysis were insufficient due to a low response rate at 8 weeks.
CONCLUSIONS


Adolescents were moderately satisfied with Breathe. However, program adjustments will be needed to address attrition and reduce perceived barriers to completing key aspects of the program. A definitive RCT to evaluate the effectiveness of the program is feasible if protocol adjustments are made to improve recruitment and retention to ensure timely study completion and increase the completeness of the data at each outcome measurement time point.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226.",2020,Retention rates at 8 weeks were 28% (13/46; Breathe group) and 58% (24/43; control group).,"['adolescents with anxiety concerns', '94 were eligible and enrolled in the study (49 adolescents', 'Adolescents aged 13 to 17 years with a self-identified anxiety concern were recruited online from health care settings and school-based mental health care services across Canada between April 2014 and May 2016', 'Adolescents With Anxiety', 'Enrolled adolescents were, on average, 15.3 years old (SD 1.2) and female (63/70, 90', '588 adolescents screened', 'adolescents with anxiety disorders', ' Easing Anxiety', '177 adolescents per group']","['ICBT with ad hoc telephone and email support (Breathe experimental group) to access to a static webpage listing anxiety resources (control group', 'Internet-Based Cognitive Behavioral Program', 'self-managed ICBT program, Breathe (Being Real', 'Internet-based cognitive behavioral therapy (ICBT']","['moderate level of satisfaction', 'Retention rates', 'recruitment and retention rates, a minimal clinically important difference (MCID) for the primary outcome, intervention acceptability and satisfaction, use of cointerventions, and health care resource use, including a cost-consequence analysis', 'change in self-reported anxiety']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4517578', 'cui_str': '15.3'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",49.0,0.139181,Retention rates at 8 weeks were 28% (13/46; Breathe group) and 58% (24/43; control group).,"[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': ""O'Connor"", 'Affiliation': 'Glenrose Rehabilitation Hospital, Edmonton, AB, Canada.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Bagnell', 'Affiliation': 'IWK Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McGrath', 'Affiliation': 'IWK Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Wozney', 'Affiliation': 'IWK Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Radomski', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Rhonda J', 'Initials': 'RJ', 'LastName': 'Rosychuk', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Curtis', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Jabbour', 'Affiliation': 'Department of Neurosurgery, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Fitzpatrick', 'Affiliation': 'IWK Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Johnson', 'Affiliation': 'University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Arto', 'Initials': 'A', 'LastName': 'Ohinmaa', 'Affiliation': 'School of Public Health, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Joyce', 'Affiliation': 'University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Newton', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, AB, Canada.'}]",JMIR mental health,['10.2196/13356']
1680,32706734,Acceptability of an Embodied Conversational Agent for Type 2 Diabetes Self-Management Education and Support via a Smartphone App: Mixed Methods Study.,"BACKGROUND


Embodied conversational agents (ECAs) are increasingly used in health care apps; however, their acceptability in type 2 diabetes (T2D) self-management apps has not yet been investigated.
OBJECTIVE


This study aimed to evaluate the acceptability of the ECA (Laura) used to deliver diabetes self-management education and support in the My Diabetes Coach (MDC) app.
METHODS


A sequential mixed methods design was applied. Adults with T2D allocated to the intervention arm of the MDC trial used the MDC app over a period of 12 months. At 6 months, they completed questions assessing their interaction with, and attitudes toward, the ECA. In-depth qualitative interviews were conducted with a subsample of the participants from the intervention arm to explore their experiences of using the ECA. The interview questions included the participants' perceptions of Laura, including their initial impression of her (and how this changed over time), her personality, and human character. The quantitative and qualitative data were interpreted using integrated synthesis.
RESULTS


Of the 93 intervention participants, 44 (47%) were women; the mean (SD) age of the participants was 55 (SD 10) years and the baseline glycated hemoglobin A1c level was 7.3% (SD 1.5%). Overall, 66 of the 93 participants (71%) provided survey responses. Of these, most described Laura as being helpful (57/66, 86%), friendly (57/66, 86%), competent (56/66, 85%), trustworthy (48/66, 73%), and likable (40/66, 61%). Some described Laura as not real (18/66, 27%), boring (26/66, 39%), and annoying (20/66, 30%). Participants reported that interacting with Laura made them feel more motivated (29/66, 44%), comfortable (24/66, 36%), confident (14/66, 21%), happy (11/66, 17%), and hopeful (8/66, 12%). Furthermore, 20% (13/66) of the participants were frustrated by their interaction with Laura, and 17% (11/66) of the participants reported that interacting with Laura made them feel guilty. A total of 4 themes emerged from the qualitative data (N=19): (1) perceived role: a friendly coach rather than a health professional; (2) perceived support: emotional and motivational support; (3) embodiment preference acceptability of a human-like character; and (4) room for improvement: need for greater congruence between Laura's words and actions.
CONCLUSIONS


These findings suggest that an ECA is an acceptable means to deliver T2D self-management education and support. A human-like character providing ongoing, friendly, nonjudgmental, emotional, and motivational support is well received. Nevertheless, the ECA can be improved by increasing congruence between its verbal and nonverbal communication and accommodating user preferences.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry CTRN12614001229662; https://tinyurl.com/yxshn6pd.",2020,"This study aimed to evaluate the acceptability of the ECA (Laura) used to deliver diabetes self-management education and support in the My Diabetes Coach (MDC) app.
","['Adults with T2D', ""participants' perceptions of Laura, including their initial impression of her (and how this changed over time), her personality, and human character""]","['Embodied Conversational Agent', 'Embodied conversational agents (ECAs', 'ECA (Laura', ""friendly coach rather than a health professional; (2) perceived support: emotional and motivational support; (3) embodiment preference acceptability of a human-like character; and (4) room for improvement: need for greater congruence between Laura's words and actions"", 'ECA']","['survey responses', 'baseline glycated hemoglobin A1c level']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007952', 'cui_str': 'Character'}]","[{'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0441472', 'cui_str': 'Action'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}]",93.0,0.0433844,"This study aimed to evaluate the acceptability of the ECA (Laura) used to deliver diabetes self-management education and support in the My Diabetes Coach (MDC) app.
","[{'ForeName': 'Shaira', 'Initials': 'S', 'LastName': 'Baptista', 'Affiliation': 'The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Wadley', 'Affiliation': 'The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Bird', 'Affiliation': 'The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Oldenburg', 'Affiliation': 'The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Speight', 'Affiliation': 'The University of Melbourne, Melbourne, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""see Authors' Contributions, .""}]",JMIR mHealth and uHealth,['10.2196/17038']
1681,32707593,"Effects of Child-Pugh B Cirrhosis on Pharmacokinetics of Tofogliflozin, a New Sodium-Glucose Co-Transporter (SGLT2) Inhibitor.","BACKGROUND


Tofogliflozin is a highly selective sodium-glucose co-transporter 2 (SGLT2) inhibitor. A mass balance study with combinations of microdoses revealed that tofogliflozin has high oral bioavailability (97.5%) and that tofogliflozin in circulation is eliminated primarily by metabolic pathways, with the liver playing a prominent role in elimination.
OBJECTIVES


This study aimed to evaluate the effect of moderate hepatic impairment on the pharmacokinetics of tofogliflozin and on the pharmacodynamics (urinary glucose excretion [UGE]).
METHODS


In an open-label, parallel-group study, 17 subjects (9 with moderate hepatic impairment [Child-Pugh Class B, score 7-9] and 8 healthy) received a single oral dose of 40 mg tofogliflozin. Plasma and urine concentrations of tofogliflozin were determined. Accumulated UGE, adverse events, and physiological and laboratory test data were monitored.
RESULTS


Geometric mean ratio (GMR; geometric mean value for subjects with moderate hepatic impairment / geometric mean value for healthy subjects) of C max  was 1.47 and GMR of AUC inf  was 1.70. Moderate hepatic impairment had only a little effect on t max  and CL R  but it prolonged MRT. The levels of cumulative UGE were similar between the 2 groups. No clinically significant adverse events, laboratory test values, or physiological test values were observed in any subject.
CONCLUSIONS


Moderate hepatic impairment increased C max  and AUC inf  of tofogliflozin by 47% and 70%, respectively. This increase in tofogliflozin exposure did not increase UGE in hepatically impaired subjects. A single oral dose of 40 mg tofogliflozin was well tolerated, supporting dose adjustment is unnecessary even in moderately hepatically impaired subjects.",2020,"No clinically significant adverse events, laboratory test values, or physiological test values were observed in any subject.
","['17 subjects (9 with moderate hepatic impairment [Child-Pugh Class B, score 7-9] and 8 healthy']","['tofogliflozin', 'Tofogliflozin', 'single oral dose of 40 mg tofogliflozin', 'Tofogliflozin, a New Sodium-Glucose Co-Transporter (SGLT2) Inhibitor']","['adverse events, laboratory test values, or physiological test values', 'C max  and AUC inf  of tofogliflozin', 'Moderate hepatic impairment', 'oral bioavailability', 'levels of cumulative UGE', 'Geometric mean ratio (GMR; geometric mean value', 'tofogliflozin exposure', 'Plasma and urine concentrations of tofogliflozin', 'Accumulated UGE, adverse events, and physiological and laboratory test data']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",17.0,0.0295616,"No clinically significant adverse events, laboratory test values, or physiological test values were observed in any subject.
","[{'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Yamada', 'Affiliation': 'Social Insurance Chuo General Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiromasa', 'Initials': 'H', 'LastName': 'Ohira', 'Affiliation': 'Fukushima Medical University Hospital, Fukushima, Japan.'}, {'ForeName': 'Fumiaki', 'Initials': 'F', 'LastName': 'Ikegami', 'Affiliation': 'Clinical Research Hospital Tokyo, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Clinical Research Hospital Tokyo, Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takahashi', 'Affiliation': 'Fukushima Medical University Hospital, Fukushima, Japan.'}, {'ForeName': 'Kazumichi', 'Initials': 'K', 'LastName': 'Abe', 'Affiliation': 'Fukushima Medical University Hospital, Fukushima, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Inano', 'Affiliation': 'Fukushima Medical University Hospital, Fukushima, Japan.'}, {'ForeName': 'Sumire', 'Initials': 'S', 'LastName': 'Shimada', 'Affiliation': 'Clinical Pharmacology Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Miyata', 'Affiliation': 'Clinical Pharmacology Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Clinical Pharmacology Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Ohba', 'Affiliation': 'Clinical Pharmacology Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kimio', 'Initials': 'K', 'LastName': 'Terao', 'Affiliation': 'Clinical Pharmacology Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Ohnishi', 'Affiliation': 'The Jikei University School of Medicine, Tokyo, Japan.'}]",Drug research,['10.1055/a-1202-0818']
1682,32715972,The effectiveness of a non-tourniquet procedure on peripheral intravenous catheterization in older patients: A pilot study.,"Background:  In an older population, insertion of peripheral intravenous catheterizations (PIVCs) are more difficult because of specific problems.  Aim:  This study aimed to determine the initial efficacy of non-tourniquet procedure during insertion of PIVC in older patients.  Design/Methods:  This quasi-experimental study was conducted in 78 older patients. The initial efficacy of non-tourniquet procedure was tested during insertion of PIVC.  Results:  This study showed that similar pain intensity scores immediately after inserting the PIVC ( p >0.05). The first-attempt success and dwell time in non-tourniquet procedure older patients were be higher/longer and phlebitis scores were lower than the control group ( p <0.05).  Conclusions:  To increase the success of PIVC first-attempt, a longer dwell time, and lower phlebitis scores in older patients, nurses should insert PIVCs at an almost flat degree and stabilize the vein without a tourniquet.  Impact statement:  The non-tourniquet procedure will lead to the long dwell time and using safely of PIVC in older patients.",2020,"In addition, the first-attempt success and dwell time in non-tourniquet procedure older patients were be higher/longer and phlebitis scores were lower than the control group (p<0.05).  ","['For older patients', 'one internal medicine clinic in Yozagat, Turkey in which 78 older patients', 'older patients']","['tourniquet procedure', 'non-tourniquet procedure']","['local pain intensity, PIVC first-attempt success, PIVC dwell time, and phlebitis grade', 'peripheral intravenous catheterization', 'phlebitis scores', 'pain intensity scores']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3838887', 'cui_str': 'Internal medicine clinic'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0412797', 'cui_str': 'Tourniquet procedure'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0031542', 'cui_str': 'Phlebitis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",78.0,0.0210696,"In addition, the first-attempt success and dwell time in non-tourniquet procedure older patients were be higher/longer and phlebitis scores were lower than the control group (p<0.05).  ","[{'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Büyükyılmaz', 'Affiliation': 'Florence Nightingale Faculty of Nursing, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}, {'ForeName': 'Merdiye', 'Initials': 'M', 'LastName': 'Şendir', 'Affiliation': 'Hamidiye Faculty of Nursing, University of Health Sciences, Istanbul, Turkey.'}, {'ForeName': 'Betül', 'Initials': 'B', 'LastName': 'Kuş', 'Affiliation': 'Health Sciences Faculty, Yozgat Bozok University, Yozgat, Turkey.'}, {'ForeName': 'Hacer', 'Initials': 'H', 'LastName': 'Yaman Güçlü', 'Affiliation': 'Education and Research Hospital, Yozgat Bozok University, Yozgat, Turkey.'}]",Contemporary nurse,['10.1080/10376178.2020.1801351']
1683,32736216,Combined exercise training improves cognitive functions in multiple sclerosis patients with cognitive impairment: A single-blinded randomized controlled trial.,"BACKGROUND


Cognitive impairment is common in patients with multiple sclerosis (MS). The effects of different exercise trainings on cognitive functions in patients with MS are promising. However, the effects are not yet clear in MS patients with cognitive impairment. This study aimed to investigate the effect of combined exercise training on different cognitive functions in MS patients with cognitive impairment.
METHODS


Relapsing-remitting and mild disabled MS patients with cognitive impairment were randomly assigned to two groups: Exercise Group (EG, n:17) and the Control Group (CG, n:17). The EG received a combined exercise training consisting of aerobic and Pilates training in three sessions per week for 8 weeks while the CG performed the relaxation exercises at home. Cognitive functions, walking capacity, fatigue, mood, and quality of life were assessed at baseline and after eight weeks using the Brief Repeatable Battery of Neuropsychological Tests (BRB-N), Six-Minute Walk Test (6-MWT), Fatigue Impact Scale (FIS), Beck's Depression Inventory (BDI) and MS Quality of Life-54 (MSQoL-54), respectively.
RESULTS


This study showed significant group-by-time interactions on long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life in favor of the EG (p<0.003). Moreover, verbal memory, visuospatial memory, verbal fluency, information processing speed, walking capacity, fatigue, and quality of life improved in the EG (p<0.05) while only verbal memory increased in the CG (p<0.05). Furthermore, the change in visuospatial memory was associated with the change in mental quality of life (r:0.352, p: 0.041) while the change in verbal fluency (r: -0.362, p:0.035) and processing speed (r: -0.356, p:0.039) were associated with the change in mood.
CONCLUSION


Combined exercise training has beneficial effects on different cognitive functions in mild disabled RRMS patients with cognitive impairment. In addition, there is a mutual relationship in improvements in cognitive functions, mood, and quality of life after exercise.",2020,"This study showed significant group-by-time interactions on long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life in favor of the EG (p<0.003).","['mild disabled RRMS patients with cognitive impairment', 'multiple sclerosis patients with cognitive impairment', 'patients with MS', 'Relapsing-remitting and mild disabled MS patients with cognitive impairment', 'patients with multiple sclerosis (MS', 'MS patients with cognitive impairment']","['Combined exercise training', 'combined exercise training consisting of aerobic and Pilates training', 'exercise trainings', 'Exercise Group (EG, n:17) and the Control Group (CG, n:17', 'combined exercise training']","['change in visuospatial memory', 'verbal fluency', 'long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life', 'processing speed', 'Cognitive functions, walking capacity, fatigue, mood, and quality of life', 'cognitive functions', ""Brief Repeatable Battery of Neuropsychological Tests (BRB-N), Six-Minute Walk Test (6-MWT), Fatigue Impact Scale (FIS), Beck's Depression Inventory (BDI) and MS Quality of Life-54 (MSQoL-54), respectively"", 'verbal memory, visuospatial memory, verbal fluency, information processing speed, walking capacity, fatigue, and quality of life improved in the EG (p<0.05) while only verbal memory', 'mental quality of life', 'cognitive functions, mood, and quality of life']","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C2733557', 'cui_str': 'Fatigue impact scale'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0502248,"This study showed significant group-by-time interactions on long-term verbal memory, walking capacity, cognitive fatigue, and physical quality of life in favor of the EG (p<0.003).","[{'ForeName': 'Cagla', 'Initials': 'C', 'LastName': 'Ozkul', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey. Electronic address: caglaozkul@hotmail.com.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Guclu-Gunduz', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Kader', 'Initials': 'K', 'LastName': 'Eldemir', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Apaydin', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Gokhan', 'Initials': 'G', 'LastName': 'Yazici', 'Affiliation': 'Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Ankara, Turkey.'}, {'ForeName': 'Ceyla', 'Initials': 'C', 'LastName': 'Irkec', 'Affiliation': 'Gazi University, Faculty of Medicine, Department of Neurology, Ankara, Turkey.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102419']
1684,32736299,"A beverage containing ora-pro-nobis flour improves intestinal health, weight, and body composition: A double-blind randomized prospective study.","OBJECTIVE


The aim of this study was to verify the effect of a beverage containing ora-pro-nobis (OPN) flour on intestinal microbiota, gastrointestinal symptoms, and anthropometric parameters in women.
METHODS


This prospective, double-blinded, randomized clinical trial included 24 women volunteers. For 6 wk, the test group received a beverage supplemented with OPN, and the control group received the same beverage without OPN. Fecal microbiota were evaluated by the fluorescence in situ hybridization method. Each participant responded to a questionnaire based on the Gastrointestinal Symptom Rating Scale. The data were analyzed by Student's t test to compare the effects between treatments (P < 0.05).
RESULTS


Supplementation with the OPN beverage reduced weight (P = 0.008), waist circumference (P = 0.010), and body fat (P = 0.000). Additionally, the treatment increased satiety (P = 0.039), reduced eructation (P = 0.038) and constipation (P = 0.017), and improved feces consistency (P = 0.017).
CONCLUSION


The OPN flour beverage has an effect on weight reduction, body fat composition, and improvement in gastrointestinal symptoms. These results highlight the beneficial effects of ora-pro-nobis flour beverage against the development of obesity.",2020,"RESULTS


Supplementation with the OPN beverage reduced weight (P = 0.008), waist circumference (P = 0.010), and body fat (P = 0.000).","['24 women volunteers', 'women']","['beverage containing ora-pro-nobis (OPN) flour', 'beverage supplemented with OPN, and the control group received the same beverage without OPN']","['weight', 'waist circumference', 'feces consistency', 'satiety', 'Gastrointestinal Symptom Rating Scale', 'intestinal health, weight, and body composition', 'weight reduction, body fat composition, and improvement in gastrointestinal symptoms', 'reduced eructation', 'Fecal microbiota', 'intestinal microbiota, gastrointestinal symptoms, and anthropometric parameters', 'body fat', 'constipation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0014724', 'cui_str': 'Eructation'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",24.0,0.165472,"RESULTS


Supplementation with the OPN beverage reduced weight (P = 0.008), waist circumference (P = 0.010), and body fat (P = 0.000).","[{'ForeName': 'Camilla Ribeiro', 'Initials': 'CR', 'LastName': 'Vieira', 'Affiliation': 'Department of Nutrition, Universidade Federal de Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Grancieri', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Viçosa, Brazil.'}, {'ForeName': 'Hércia Stampini Duarte', 'Initials': 'HSD', 'LastName': 'Martino', 'Affiliation': 'Department of Nutrition and Health, Universidade Federal de Viçosa, Viçosa, Brazil.'}, {'ForeName': 'Dionéia Evangelista', 'Initials': 'DE', 'LastName': 'César', 'Affiliation': 'Department of Biology, Universidade Federal de Juiz de Fora, Juiz de Fora, Brazil.'}, {'ForeName': 'Roberta Ribeiro Silva', 'Initials': 'RRS', 'LastName': 'Barra', 'Affiliation': 'Department of Nutrition, Universidade Federal de Alfenas, Alfenas, Brazil. Electronic address: betaribeiro@hotmail.com.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110869']
1685,32737072,Effect of the sphingosine-1-phosphate receptor modulator ozanimod on leukocyte subtypes in relapsing MS.,"OBJECTIVE


To better understand ozanimod's mechanism of action (MOA), we conducted exploratory analyses from a phase 1 study to characterize ozanimod's effect on circulating leukocyte subsets in patients with relapsing multiple sclerosis.
METHODS


An open-label pharmacodynamic study randomized patients to oral ozanimod hydrochloride (HCl) 0.5 (n = 13) or 1 mg/d (n = 11) for ∼12 weeks (including 7-day dose escalation). Circulating leukocyte subsets were quantified using flow cytometry (days 28, 56, and 85) and epigenetic cell counting (days 2, 5, 28, 56, and 85) and compared with baseline (day 1) using descriptive statistics.
RESULTS


Ozanimod caused dose-dependent reductions in absolute lymphocyte counts. Observed by both methodologies, circulating CD19 +  B- and CD3 +  T-cell counts were reduced by >50% with ozanimod HCl 0.5 mg and >75% with 1 mg at day 85. Based on flow cytometry, ozanimod HCl 1 mg showed greater decreases in CD4 +  than CD8 +  T cells, greater decreases in both CD4 +  and CD8 +  central memory vs effector memory T cells, and reductions in mean CD4 +  and CD8 +  naive T cells by ≥90% at day 85. In the flow cytometry analysis, changes in monocytes, natural killer, and natural killer T cells were minimal. Using epigenetic cell counting, greater reductions for Th17 than T regulatory cells were determined.
CONCLUSION


Ozanimod induced dose-dependent reductions in circulating B- and T-cell counts and differential effects on naive and memory CD4 +  and CD8 +  T cells and CD19 +  B cells. Data characterized with both a novel epigenetic cell-counting method and flow cytometry support ozanimod's MOA.
CLINICAL TRIAL REGISTRATION


clinicaltrials.gov NCT02797015.",2020,"Based on flow cytometry, ozanimod HCl 1 mg showed greater decreases in CD4 +  than CD8 +  T cells, greater decreases in both CD4 +  and CD8 +  central memory vs effector memory T cells, and reductions in mean CD4 +  and CD8 +  naive T cells by ≥90% at day 85.","['patients with relapsing multiple sclerosis', 'relapsing MS']","['sphingosine-1-phosphate receptor modulator ozanimod', 'ozanimod HCl', 'oral ozanimod hydrochloride (HCl']","['circulating CD19 +  B- and CD3 +  T-cell counts', 'Circulating leukocyte subsets', 'absolute lymphocyte counts', 'circulating B- and T-cell counts and differential effects on naive and memory CD4 +  and CD8 +  T cells and CD19 +  B cells', 'CD4 +  and CD8 +  central memory vs effector memory T cells, and reductions in mean CD4 +  and CD8 +  naive T cells', 'changes in monocytes, natural killer, and natural killer T cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]","[{'cui': 'C4760638', 'cui_str': 'Sphingosine Receptor Modulators'}, {'cui': 'C4278675', 'cui_str': 'ozanimod'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0108748', 'cui_str': 'Lymphocyte antigen CD19'}, {'cui': 'C1277786', 'cui_str': 'CD3 T-cell count procedure'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0443199', 'cui_str': 'Differential'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4543203', 'cui_str': 'Effector'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C2350466', 'cui_str': 'Natural Killer T-Cell'}]",,0.0568721,"Based on flow cytometry, ozanimod HCl 1 mg showed greater decreases in CD4 +  than CD8 +  T cells, greater decreases in both CD4 +  and CD8 +  central memory vs effector memory T cells, and reductions in mean CD4 +  and CD8 +  naive T cells by ≥90% at day 85.","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'From Bristol-Myers Squibb Company (S.H., J.Q.T.), Princeton, NJ; Data Clarity Consulting Ltd. (H.S.), Stockport, England, United Kingdom; and Department of Neurology, Weill Institute for Neurosciences (C.M.S., B.A.C.C., S.S.Z.), and Program in Immunology (C.M.S., S.S.Z.), University of California San Francisco (UCSF). sarah.harris@bms.com.'}, {'ForeName': 'Jonathan Q', 'Initials': 'JQ', 'LastName': 'Tran', 'Affiliation': 'From Bristol-Myers Squibb Company (S.H., J.Q.T.), Princeton, NJ; Data Clarity Consulting Ltd. (H.S.), Stockport, England, United Kingdom; and Department of Neurology, Weill Institute for Neurosciences (C.M.S., B.A.C.C., S.S.Z.), and Program in Immunology (C.M.S., S.S.Z.), University of California San Francisco (UCSF).'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Southworth', 'Affiliation': 'From Bristol-Myers Squibb Company (S.H., J.Q.T.), Princeton, NJ; Data Clarity Consulting Ltd. (H.S.), Stockport, England, United Kingdom; and Department of Neurology, Weill Institute for Neurosciences (C.M.S., B.A.C.C., S.S.Z.), and Program in Immunology (C.M.S., S.S.Z.), University of California San Francisco (UCSF).'}, {'ForeName': 'Collin M', 'Initials': 'CM', 'LastName': 'Spencer', 'Affiliation': 'From Bristol-Myers Squibb Company (S.H., J.Q.T.), Princeton, NJ; Data Clarity Consulting Ltd. (H.S.), Stockport, England, United Kingdom; and Department of Neurology, Weill Institute for Neurosciences (C.M.S., B.A.C.C., S.S.Z.), and Program in Immunology (C.M.S., S.S.Z.), University of California San Francisco (UCSF).'}, {'ForeName': 'Bruce A C', 'Initials': 'BAC', 'LastName': 'Cree', 'Affiliation': 'From Bristol-Myers Squibb Company (S.H., J.Q.T.), Princeton, NJ; Data Clarity Consulting Ltd. (H.S.), Stockport, England, United Kingdom; and Department of Neurology, Weill Institute for Neurosciences (C.M.S., B.A.C.C., S.S.Z.), and Program in Immunology (C.M.S., S.S.Z.), University of California San Francisco (UCSF).'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Zamvil', 'Affiliation': 'From Bristol-Myers Squibb Company (S.H., J.Q.T.), Princeton, NJ; Data Clarity Consulting Ltd. (H.S.), Stockport, England, United Kingdom; and Department of Neurology, Weill Institute for Neurosciences (C.M.S., B.A.C.C., S.S.Z.), and Program in Immunology (C.M.S., S.S.Z.), University of California San Francisco (UCSF).'}]",Neurology(R) neuroimmunology & neuroinflammation,['10.1212/NXI.0000000000000839']
1686,32737087,"Open-label, multicentre, single-arm trial of monthly injections of depot buprenorphine in people with opioid dependence: protocol for the CoLAB study.","INTRODUCTION


Opioid agonist treatment is effective for opioid dependence and newer extended-release buprenorphine (BUP-XR) injections represent a significant development. The Community Long-Acting Buprenorphine (CoLAB) study aims to evaluate client outcomes among people with opioid dependence receiving 48 weeks of BUP-XR treatment, and examines the implementation of BUP-XR in diverse community healthcare settings in Australia.
METHODS AND ANALYSIS


The CoLAB study is a prospective single-arm, multicentre, open-label trial of monthly BUP-XR injections in people with opioid dependence. Participants are being recruited from a network of general practitioner and specialist drug treatment services located in the states of New South Wales, Victoria and South Australia in Australia. Following a minimum 7 days on 8-32 mg of sublingual buprenorphine (±naloxone), participants will receive monthly subcutaneous BUP-XR injections administered by a healthcare practitioner at intervals of 28 days (-2/+14 days). The primary endpoint is participant retention in treatment at 48 weeks after treatment initiation. Secondary endpoints will evaluate dosing schedule variations, craving, withdrawal, substance use, health and well-being, and client-reported treatment experience. Qualitative and costing substudies will examine implementation barriers and facilitators at the client and provider level.
ETHICS AND DISSEMINATION


The study has received ethics approval from the St Vincent's Hospital Sydney Human Research Ethics Committee (Ref. HREC/18/SVH/221). The findings will be disseminated via publication in peer-reviewed journals, presentations at national and international scientific conferences, and in relevant community organisation publications and forums.
TRIAL REGISTRATION NUMBER


NCT03809143 PROTOCOL IDENTIFIER: CoLAB1801, V.4.0 dated 01 August 2019.",2020,"The Community Long-Acting Buprenorphine (CoLAB) study aims to evaluate client outcomes among people with opioid dependence receiving 48 weeks of BUP-XR treatment, and examines the implementation of BUP-XR in diverse community healthcare settings in Australia.
","['people with opioid dependence receiving 48 weeks of BUP-XR treatment, and examines the implementation of BUP-XR in diverse community healthcare settings in Australia', 'Participants are being recruited from a network of general practitioner and specialist drug treatment services located in the states of New South Wales, Victoria and South Australia in Australia', 'people with opioid dependence']","['depot buprenorphine', 'Buprenorphine (CoLAB', 'subcutaneous BUP-XR injections', 'BUP-XR injections', 'sublingual buprenorphine (±naloxone']","['participant retention', 'dosing schedule variations, craving, withdrawal, substance use, health and well-being, and client-reported treatment experience']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524662', 'cui_str': 'Opioid dependence'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0086034', 'cui_str': 'Community Healthcare'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0037715', 'cui_str': 'South Australia'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",,0.105725,"The Community Long-Acting Buprenorphine (CoLAB) study aims to evaluate client outcomes among people with opioid dependence receiving 48 weeks of BUP-XR treatment, and examines the implementation of BUP-XR in diverse community healthcare settings in Australia.
","[{'ForeName': 'Briony', 'Initials': 'B', 'LastName': 'Larance', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Byrne', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Discipline of Addiction Medicine, University of Sydney, Surry Hills, New South Wales, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Nielsen', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Grebely', 'Affiliation': 'The Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Degenhardt', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jeyran', 'Initials': 'J', 'LastName': 'Shahbazi', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Shanahan', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Lancaster', 'Affiliation': 'Centre for Social Research in Health, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Dore', 'Affiliation': 'The Kirby Institute, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ali', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Farrell', 'Affiliation': 'National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia michael.farrell@unsw.edu.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034389']
1687,32737091,Choice of ANaesthesia for EndoVAScular treatment of acute ischaemic stroke at posterior circulation (CANVAS II): protocol for an exploratory randomised controlled study.,"INTRODUCTION


Observational and interventional studies indicate that the type of anaesthesia may be associated with the postprocedural neurological function in patients with anterior circulation acute ischaemic stroke undergoing endovascular treatment. Patients with acute posterior circulation ischaemic stroke may experience different physiological changes and result in severe neurological outcome. However, the effect of the type of anaesthesia on postprocedure neurological function remained unclear in this population.
METHODS AND ANALYSIS


This is an exploratory randomised controlled trial that will be carried out at Beijing Tiantan Hospital, Capital Medical University. Patients with acute posterior circulation ischaemic stroke and deemed suitable for emergency endovascular recanalisation will be recruited in this trial. Eighty-four patients will be randomised to receive either general anaesthesia or conscious sedation with 1:1 allocation ratio. The primary endpoint is the 90-day modified Rankin Scale.
ETHICS AND DISSEMINATION


The study has been reviewed by and approved by Ethics Committee of Beijing Tiantan Hospital of Capital Medical University (KY2017-074-02). If the results are positive, the study will indicate whether the type of anaesthesia affects neurological outcome after endovascular treatment of posterior stroke. The findings of the study will be published in peer-reviewed journals and presented at national or international conferences.
TRIAL REGISTRATION NUMBER


NCT03317535.",2020,"If the results are positive, the study will indicate whether the type of anaesthesia affects neurological outcome after endovascular treatment of posterior stroke.","['Patients with acute posterior circulation ischaemic stroke', 'Beijing Tiantan Hospital of Capital Medical University (KY2017-074-02', 'patients with anterior circulation acute ischaemic stroke undergoing endovascular treatment', 'acute ischaemic stroke at posterior circulation (CANVAS II', 'Beijing Tiantan Hospital, Capital Medical University']","['ANaesthesia', 'general anaesthesia or conscious sedation with 1:1 allocation ratio', 'emergency endovascular recanalisation']","['90-day modified Rankin Scale', 'postprocedure neurological function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006909', 'cui_str': 'Capital'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",84.0,0.174259,"If the results are positive, the study will indicate whether the type of anaesthesia affects neurological outcome after endovascular treatment of posterior stroke.","[{'ForeName': 'Fa', 'Initials': 'F', 'LastName': 'Liang', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Youxuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xiuheng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Minyu', 'Initials': 'M', 'LastName': 'Jian', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhongrong', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Department of Interventional Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ruquan', 'Initials': 'R', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yuming', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China florapym766@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-036358']
1688,32737183,Effects of Inactivation of the Periaqueductal Gray on Song Production in Testosterone-Treated Male Canaries ( Serinus canaria ).,"Male canaries ( Serinus canaria ) display seasonal changes in the motivation to sing which have been found to be dependent on the action of testosterone (T). During the breeding season when T is high, males sing at a higher rate compared with males with low T. The effect of T on song rate is known to be mediated by the medial preoptic nucleus (POM); however, it is unclear how T signaling in POM impacts song production. One potential mechanism is via modulation of dopaminergic input into song control nuclei by the periaqueductal gray (PAG). In order to test the role of PAG in T-mediated song production, we treated male canaries with peripheral T implants and implanted a guide cannula targeting the PAG. Through this guide cannula, we transiently inactivated PAG with injections of the GABA A  agonist, muscimol. Each bird received multiple infusions of both muscimol and saline with a 48-h washout period between treatments. The order of injection type was randomized and counterbalanced between individuals. Muscimol infusion into the PAG, but not nearby regions, increased the latency to sing post-injection. These results support the hypothesis that PAG is involved in the production of song, potentially mediating the motivation to sing or alternatively interfering with the pre-motor activity of nucleus RA. Other song features were however not affected.",2020,"Muscimol infusion into the PAG, but not nearby regions, increased the latency to sing post-injection.",['Testosterone-Treated Male Canaries ( Serinus canaria '],['muscimol and saline'],[],"[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0006824', 'cui_str': 'Genus Serinus'}, {'cui': 'C1095844', 'cui_str': 'Serinus canaria'}]","[{'cui': 'C0026818', 'cui_str': 'Muscimol'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]",[],,0.0304729,"Muscimol infusion into the PAG, but not nearby regions, increased the latency to sing post-injection.","[{'ForeName': 'Chelsea M', 'Initials': 'CM', 'LastName': 'Haakenson', 'Affiliation': 'Program in Neuroscience and Cognitive Science, Department of Psychology, University of Maryland, College Park, MD 20742, chaakens@umd.edu.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Balthazart', 'Affiliation': 'Laboratory of Behavioral Neuroendocrinology, GIGA Neurosciences, University of Liege, 15 Avenue Hippocrate, 4000, Liege, Belgium.'}, {'ForeName': 'Gregory F', 'Initials': 'GF', 'LastName': 'Ball', 'Affiliation': 'Program in Neuroscience and Cognitive Science, Department of Psychology, University of Maryland, College Park, MD 20742.'}]",eNeuro,['10.1523/ENEURO.0048-20.2020']
1689,32736046,"Evaluation of sedative effects of an intranasal dosage form containing saffron, lettuce seeds and sweet violet in primary chronic insomnia: A randomized, double-dummy, double-blind placebo controlled clinical trial.","ETHNOPHARMACOLOGICAL RELEVANCE


Traditional Persian Medicine (TPM) has been established as a valuable source of medicinal plants for the treatment of insomnia for thousands of years. Accordingly, oil extracts from plants' parts have been widely used to alleviate central nervous system (CNS) ailments including sleep disorders. A number of preparations have been recommended by TPM for the treatment of insomnia. Among them, an intranasal formulation containing oily macerates of Viola odorata L., Crocus sativus L. and Lactuca sativa L. stands out.
AIM OF THE STUDY


In the present double-dummy, double-blind placebo controlled clinical trial, we aim to evaluate the effectiveness of a combination of violet oil, saffron oil, and lettuce seeds oil nasal drop compared with the placebo (sesame oil).
MATERIALS AND METHODS


Fifty patients with primary chronic insomnia were randomly assigned in TPM-treatment or placebo groups, received either two drops of the herbal oil or placebo into each nostril every noon and evening for 8 weeks. Before the study commencement and after 1, 4 and 8 weeks of treatment, Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires were completed by all patients. The primary outcome measure was considered as any changes in ISI scores between the first visit and after 8 weeks. Changes in PSQI scores during the study and possible side effects were also assessed. The multicompound herbal oil was standardized using HPLC analysis and contained 0.02 mg/mL crocin and 4 μg/mL isoquercitrin.
RESULTS


Our study revealed a significant reduction in the ISI and PSQI scores from baseline by the study endpoint (P ≤ 0.01). The mean ISI scores in week 8 decreased significantly for the intervention group (P = 0.001) and also the placebo group (P < 0.01) when compared with baseline. Moreover, the use of hypnotic drugs in the intervention group was significantly reduced (P < 0.001), while in the control group was maintained at baseline level.
CONCLUSIONS


It seems that intranasal use of the multi-herbal preparation can be used to improve chronic insomnia and to reduce the dose of conventional hypnotic medications in insomniac patients.",2020,The mean ISI scores in week 8 decreased significantly for the intervention group (P=0.001) and also the placebo group (P<0.01) when compared with baseline.,"['primary chronic insomnia', 'Fifty patients with primary chronic insomnia']","['violet oil, saffron oil, and lettuce seeds oil nasal drop', 'placebo (sesame oil', 'TPM-treatment or placebo', 'TPM', 'intranasal dosage form containing saffron, lettuce seeds and sweet violet', 'herbal oil or placebo', 'placebo']","['ISI scores', 'mean ISI scores', 'chronic insomnia', 'PSQI scores', 'ISI and PSQI scores', 'Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) questionnaires']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0330463', 'cui_str': 'Viola'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0242765', 'cui_str': 'Lettuce'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036845', 'cui_str': 'Sesame Oil'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0013058', 'cui_str': 'Pharmaceutical dose form'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0330464', 'cui_str': 'Viola odorata'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}]","[{'cui': 'C4706228', 'cui_str': 'ISI (Insomnia Severity Index) score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",50.0,0.415055,The mean ISI scores in week 8 decreased significantly for the intervention group (P=0.001) and also the placebo group (P<0.01) when compared with baseline.,"[{'ForeName': 'Zhila', 'Initials': 'Z', 'LastName': 'Taherzadeh', 'Affiliation': 'Targeted Drug Delivery Research Center, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hosein', 'Initials': 'H', 'LastName': 'Khaluyan', 'Affiliation': 'Department of Traditional Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Iranshahy', 'Affiliation': 'Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Fariborz', 'Initials': 'F', 'LastName': 'Rezaeitalab', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Hosein', 'Initials': 'MH', 'LastName': 'Eshaghi Ghalibaf', 'Affiliation': 'Anesthesiology, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Behjat', 'Initials': 'B', 'LastName': 'Javadi', 'Affiliation': 'Department of Traditional Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: javadib@mums.ac.ir.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113116']
1690,32736164,The presence of a caregiver is associated with patient outcomes in patients with Parkinson's disease and atypical parkinsonisms.,"INTRODUCTION


Approximately 88% of men and 79% of women with Parkinson's disease (PD) identify an informal caregiver. Although caregivers can play a key role in supporting patients, little is known about how and whether PD patients with and without caregivers differ in terms of physical, cognitive, and mood outcomes. This study explored whether caregiver presence was associated with variations in patient presentation and outcomes in a palliative PD and atypical PD population.
METHODS


Secondary data on individuals with PD and their caregivers came from baseline data of a 3-site randomized controlled trial of outpatient palliative care for PD in the US and Canada. Measures included: MDS UPDRS III, Montreal Cognitive Assessment, quality of life (QOL) measures, depression, prolonged grief, spirituality (FACIT SP-12) and Palliative Performance Scale.
RESULTS


Of 210 participants, 175 (83%) had a caregiver. Patients with caregivers had greater motor difficulty, lower cognitive scores, and greater palliative needs as measured by the Palliative Performance Scale. Despite poorer cognitive and motor function, those with caregivers had higher QOL as measured by the Quality of Life in Alzheimer Disease and less spiritual distress. There were no group differences on anxiety, depression, or grief. Caregiver presence moderated the association between lower MoCA score and worse motor symptoms.
CONCLUSION


Findings of the present study highlight the influence of caregiver engagement on PD patient outcomes. These findings have implications for clinical practice and suggest that presence of a caregiver may be an important modifying variable on patient outcomes to examine in future research.",2020,"Patients with caregivers had greater motor difficulty, lower cognitive scores, and greater palliative needs as measured by the Palliative Performance Scale.","['Of 210 participants, 175 (83%) had a caregiver', ""patients with Parkinson's disease and atypical parkinsonisms"", 'Secondary data on individuals with PD and their caregivers came from baseline data of a 3-site randomized controlled trial of outpatient palliative care for PD in the US and Canada', ""Approximately 88% of men and 79% of women with Parkinson's disease (PD) identify an informal caregiver""]",[],"['Palliative Performance Scale', 'MDS UPDRS III, Montreal Cognitive Assessment, quality of life (QOL) measures, depression, prolonged grief, spirituality (FACIT SP-12) and Palliative Performance Scale', 'anxiety, depression, or grief', 'lower MoCA score and worse motor symptoms', 'motor difficulty, lower cognitive scores']","[{'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0585086', 'cui_str': 'Has a caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C4302185', 'cui_str': 'Atypical Parkinsonism'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}]",[],"[{'cui': 'C4720846', 'cui_str': 'Palliative performance scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",210.0,0.115968,"Patients with caregivers had greater motor difficulty, lower cognitive scores, and greater palliative needs as measured by the Palliative Performance Scale.","[{'ForeName': 'Lindsay Penny', 'Initials': 'LP', 'LastName': 'Prizer', 'Affiliation': 'Division of General Medicine and Geriatrics, Emory University School of Medicine, 6 Executive Park, 1st Floor, Atlanta, GA, 30329, USA. Electronic address: lprizer@emory.edu.'}, {'ForeName': 'Benzi M', 'Initials': 'BM', 'LastName': 'Kluger', 'Affiliation': 'Departments of Neurology and Medicine, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Sillau', 'Affiliation': 'Department of Neurology, University of Colorado School of Medicine, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Katz', 'Affiliation': 'Weill Institute for Neurosciences, School of Medicine, University of California San Francisco, USA.'}, {'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Galifianakis', 'Affiliation': 'Weill Institute for Neurosciences, School of Medicine, University of California San Francisco, USA.'}, {'ForeName': 'Janis M', 'Initials': 'JM', 'LastName': 'Miyasaki', 'Affiliation': 'Parkinson and Movement Disorders Program, Neuropalliative Care, Department of Medicine, University of Alberta, Canada.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2020.07.003']
1691,32738408,Positive Health Check evaluation: A type 1 hybrid design randomized trial to decrease HIV viral loads in patients seen in HIV primary care.,"For people with HIV, important transmission prevention strategies include early initiation and adherence to antiretroviral therapy and retention in clinical care with the goal of reducing viral loads as quickly as possible. Consequently, at this point in the HIV epidemic, innovative and effective strategies are urgently needed to engage and retain people in health care to support medication adherence. To address this gap, the Positive Health Check Evaluation Trial uses a type 1 hybrid randomized trial design to test whether the use of a highly tailored video doctor intervention will reduce HIV viral load and retain people with HIV in health care. Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only. The primary aim is to determine the effectiveness of the intervention. A second aim is to understand the implementation potential of the intervention in clinic workflows, and a third aim is to assess the costs of intervention implementation. The trial findings will have important real-world applicability for understanding how digital interventions that take the form of video doctors can be used to decrease viral load and to support retention in care among diverse patients attending HIV primary care clinics.",2020,Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only.,"['diverse patients attending HIV primary care clinics', 'Eligible and consenting patients from four HIV primary care clinical sites', 'people with HIV in health care', 'patients seen in HIV primary care']",['Positive Health Check intervention in addition to the standard of care or the standard of care only'],['HIV viral loads'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C1168369', 'cui_str': 'HIV viral load'}]",4.0,0.0882936,Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only.,"[{'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America. Electronic address: melewis@rti.org.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Harshbarger', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Bann', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Burrus', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Peinado', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Bryan R', 'Initials': 'BR', 'LastName': 'Garner', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Khavjou', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Ram K', 'Initials': 'RK', 'LastName': 'Shrestha', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Karns', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Craig B', 'Initials': 'CB', 'LastName': 'Borkowf', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Brittany A', 'Initials': 'BA', 'LastName': 'Zulkiewicz', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'RTI International, Research Triangle Park, NC, United States of America.'}, {'ForeName': 'Carla A', 'Initials': 'CA', 'LastName': 'Galindo', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, United States of America.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'DallaPiazza', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, NJ, United States of America.'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Holm', 'Affiliation': 'NO AIDS Task Force dba CrescentCare, New Orleans, LA, United States of America.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'Division of Infectious Diseases, Emory University School of Medicine, Emory Vaccine Center, and Rollins School of Public Health, Atlanta, GA, United States of America; Atlanta VA Medical Center, Decatur, GA, United States of America.'}, {'ForeName': 'Charurut', 'Initials': 'C', 'LastName': 'Somboonwit', 'Affiliation': 'University of South Florida, Morsani College of Medicine, Tampa, FL, United States of America.'}, {'ForeName': 'Shobha', 'Initials': 'S', 'LastName': 'Swaminathan', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, NJ, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106097']
1692,32738416,"Afatinib in patients with advanced non-small cell lung cancer harboring HER2 mutations, previously treated with chemotherapy: A phase II trial.","BACKGROUND


Despite 1-4 % of NSCLC tumors harboring mutations in the HER2 gene, there are no approved HER2-pathway-targeted treatments available. We report an open-label, single-arm, multicenter phase II study investigating the efficacy and safety of afatinib in Asian patients with HER2-mutation positive (HER2m+) NSCLC.
METHODS


Eligible patients for Part A had confirmed stage IIIb/IV HER2m + NSCLC, had failed one or two prior lines of chemotherapy, and were EGFR/HER2-inhibitor naïve. Patients received oral afatinib 40 mg/day in continuous 28-day cycles, until disease progression or intolerable adverse events (AEs). Patients qualified for Part B if they had > 12 weeks' clinical benefit and Eastern Cooperative Oncology Group performance status ≤ 2. In Part B, patients were to receive afatinib at the last received dose, plus paclitaxel 80 mg/m 2  weekly, until disease progression or intolerable AEs. The primary endpoint in Part A was objective response (OR); secondary endpoints included disease control (DC), progression-free survival (PFS), and overall survival (OS). Further exploratory endpoints were OR, DC, and PFS in Part B.
RESULTS


Eighteen patients received afatinib in Part A. No patient achieved an OR; 11 patients (61.1 %) achieved stable disease, and six patients (33.3 %) had progressive disease. DC rate was therefore 61.1 % (95 % confidence interval [CI]: 35.7, 82.7). A decrease in tumor size from baseline of > 0 to < 30 % was observed in eight patients. At the time of analysis, 16 patients (88.9 %) had progressed or died. Median PFS was 2.76 months (95 % CI: 1.87, 4.60) and median OS was 10.02 months (95 % CI: 8.47, 10.08). All patients experienced ≥ 1 AE, most commonly diarrhea (66.7 %) and rash (33.3 %). No patients met the inclusion criteria for Part B, and recruitment was slow; therefore, the study was terminated.
CONCLUSIONS


This study found no clinical benefit of afatinib for EGFR TKI-naïve patients with HER2m + NSCLC.",2020,"Median PFS was 2.76 months (95 % CI: 1.87, 4.60) and median OS was 10.02 months (95 % CI: 8.47, 10.08).","['Eighteen patients received afatinib in Part A', ""Patients qualified for Part B if they had > 12 weeks' clinical benefit and Eastern Cooperative Oncology Group performance status ≤ 2"", 'EGFR TKI-naïve patients with HER2m\u202f+\u202fNSCLC', 'Asian patients with HER2-mutation positive (HER2m+) NSCLC', 'Eligible patients for Part A had confirmed stage IIIb/IV HER2m', 'patients with advanced non-small cell lung cancer harboring HER2 mutations']","['Afatinib', 'oral afatinib', 'plus paclitaxel 80\u202fmg/m 2  weekly, until disease progression or intolerable AEs', 'chemotherapy', 'afatinib']","['OR, DC, and PFS in Part B', 'diarrhea', 'DC rate', 'progressive disease', 'Median PFS', 'median OS', 'objective response (OR); secondary endpoints included disease control (DC), progression-free survival (PFS), and overall survival (OS', 'progressed or died', 'efficacy and safety', 'tumor size', 'stable disease', 'rash']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}]","[{'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]",,0.160329,"Median PFS was 2.76 months (95 % CI: 1.87, 4.60) and median OS was 10.02 months (95 % CI: 8.47, 10.08).","[{'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Chengzhi', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, Guangdong, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yongqian', 'Initials': 'Y', 'LastName': 'Shu', 'Affiliation': 'The First Affiliated Hospital with Nanjing Medical University, Jiangsu, China.'}, {'ForeName': 'Jacky', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China.'}, {'ForeName': 'Hairui', 'Initials': 'H', 'LastName': 'Hua', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co., Ltd, Shanghai, China.'}, {'ForeName': 'Dennis Chin-Lun', 'Initials': 'DC', 'LastName': 'Huang', 'Affiliation': 'Boehringer Ingelheim Taiwan Limited, Taipei, Taiwan.'}, {'ForeName': 'Caicun', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Medical Oncology, Shanghai Pulmonary Hospital, Shanghai, China. Electronic address: caicunzhoudr@163.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.07.017']
1693,32702309,"Pathological response in children and adults with large unresected intermediate-grade or high-grade soft tissue sarcoma receiving preoperative chemoradiotherapy with or without pazopanib (ARST1321): a multicentre, randomised, open-label, phase 2 trial.","BACKGROUND


Outcomes for children and adults with advanced soft tissue sarcoma are poor with traditional therapy. We investigated whether the addition of pazopanib to preoperative chemoradiotherapy would improve pathological near complete response rate compared with chemoradiotherapy alone.
METHODS


In this joint Children's Oncology Group and NRG Oncology multicentre, randomised, open-label, phase 2 trial, we enrolled eligible adults (aged ≥18 years) and children (aged between 2 and <18 years) from 57 hospitals in the USA and Canada with unresected, newly diagnosed trunk or extremity chemotherapy-sensitive soft tissue sarcoma, which were larger than 5 cm in diameter and of intermediate or high grade. Eligible patients had Lansky (if aged ≤16 years) or Karnofsky (if aged >16 years) performance status score of at least 70. Patients received ifosfamide (2·5 g/m 2  per dose intravenously on days 1-3 with mesna) and doxorubicin (37·5 mg/m 2  per dose intravenously on days 1-2) with 45 Gy preoperative radiotherapy, followed by surgical resection at week 13. Patients were randomly assigned (1:1) using a web-based system, in an unmasked manner, to receive oral pazopanib (if patients <18 years 350 mg/m 2  once daily; if patients ≥18 years 600 mg once daily) or not (control group), with pazopanib not given immediately before or after surgery at week 13. The study projected 100 randomly assigned patients were needed to show an improvement in the number of participants with a 90% or higher pathological response at week 13 from 40% to 60%. Analysis was done per protocol. This study has completed accrual and is registered with ClinicalTrials.gov, NCT02180867.
FINDINGS


Between July 7, 2014, and Oct 1, 2018, 81 eligible patients were enrolled and randomly assigned to the pazopanib group (n=42) or the control group (n=39). At the planned second interim analysis with 42 evaluable patients and a median follow-up of 0·8 years (IQR 0·3-1·6) in the pazopanib group and 1 year (0·3-1·6) in the control group, the number of patients with a 90% pathological response or higher was 14 (58%) of 24 patients in the pazopanib group and four (22%) of 18 patients in the control group, with a between-group difference in the number of 90% or higher pathological response of 36·1% (83·8% CI 16·5-55·8). On the basis of an interim analysis significance level of 0·081 (overall one-sided significance level of 0·20, power of 0·80, and O'Brien-Fleming-type cumulative error spending function), the 83·8% CI for response difference was between 16·5% and 55·8% and thus excluded 0. The improvement in pathological response rate with the addition of pazopanib crossed the predetermined boundary and enrolment was stopped. The most common grade 3-4 adverse events were leukopenia (16 [43%] of 37 patients), neutropenia (15 [41%]), and febrile neutropenia (15 [41%]) in the pazopanib group, and neutropenia (three [9%] of 35 patients) and febrile neutropenia (three [9%]) in the control group. 22 (59%) of 37 patients in the pazopanib group had a pazopanib-related serious adverse event. Paediatric and adult patients had a similar number of grade 3 and 4 toxicity. There were seven deaths (three in the pazopanib group and four in the control group), none of which were treatment related.
INTERPRETATION


In this presumed first prospective trial of soft tissue sarcoma spanning nearly the entire age spectrum, adding pazopanib to neoadjuvant chemoradiotherapy improved the rate of pathological near complete response, suggesting that this is a highly active and feasible combination in children and adults with advanced soft tissue sarcoma. The comparison of survival outcomes requires longer follow-up.
FUNDING


National Institutes of Health, St Baldrick's Foundation, Seattle Children's Foundation.",2020,"The most common grade 3-4 adverse events were leukopenia (16 [43%] of 37 patients), neutropenia (15 [41%]), and febrile neutropenia (15 [41%]) in the pazopanib group, and neutropenia (three [9%] of 35 patients) and febrile neutropenia (three [9%]) in the control group.","['Between July 7, 2014, and Oct 1, 2018, 81 eligible patients', 'Eligible patients had Lansky (if aged ≤16 years) or Karnofsky (if aged >16 years) performance status score of at least 70', 'children and adults with advanced soft tissue sarcoma', 'enrolled eligible adults (aged ≥18 years) and children (aged between 2 and <18 years) from 57 hospitals in the USA and Canada with unresected, newly diagnosed trunk or extremity chemotherapy-sensitive soft tissue sarcoma, which were larger than 5 cm in diameter and of intermediate or high grade', 'group (n=42) or the control group (n=39', 'children and adults with large unresected intermediate-grade or high-grade soft tissue sarcoma receiving']","['pazopanib', 'pazopanib to neoadjuvant chemoradiotherapy', 'doxorubicin (37·5 mg/m 2  per dose intravenously on days 1-2) with 45 Gy preoperative radiotherapy', 'ifosfamide', 'pazopanib to preoperative chemoradiotherapy', 'oral pazopanib', 'preoperative chemoradiotherapy with or without pazopanib (ARST1321']","['pazopanib-related serious adverse event', 'febrile neutropenia', 'neutropenia', 'grade 3 and 4 toxicity', 'Pathological response', 'pathological response rate', 'pathological response', 'leukopenia']","[{'cui': 'C1442824', 'cui_str': 'POU2F1 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky performance status'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}]",100.0,0.19607,"The most common grade 3-4 adverse events were leukopenia (16 [43%] of 37 patients), neutropenia (15 [41%]), and febrile neutropenia (15 [41%]) in the pazopanib group, and neutropenia (three [9%] of 35 patients) and febrile neutropenia (three [9%]) in the control group.","[{'ForeName': 'Aaron R', 'Initials': 'AR', 'LastName': 'Weiss', 'Affiliation': 'Department of Pediatrics, Maine Medical Center, Portland, ME, USA. Electronic address: weissa2@mmc.org.'}, {'ForeName': 'Yen-Lin', 'Initials': 'YL', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Scharschmidt', 'Affiliation': ""Department of Orthopaedics, James Cancer Hospital and Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Yueh-Yun', 'Initials': 'YY', 'LastName': 'Chi', 'Affiliation': 'Department of Pediatrics and Preventative Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Jennifer O', 'Initials': 'JO', 'LastName': 'Black', 'Affiliation': ""Department of Pathology, Children's Hospital Colorado, Aurora, CO, USA.""}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Davis', 'Affiliation': 'Department of Pathology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Julie C', 'Initials': 'JC', 'LastName': 'Fanburg-Smith', 'Affiliation': ""Department of Pathology, Penn State Children's Hospital, Hershey, PA, USA.""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Zambrano', 'Affiliation': 'Department of Pathology, Rocky Mountain Hospital for Children, Presbyterian St Luke Medical Centre, Denver, CO, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Anderson', 'Affiliation': 'Department of Biostatistics and Research Decision Sciences, Merck and Co, North Wales, PA, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Arens', 'Affiliation': ""Department of Clinical Trials, Connecticut Children's Medical Center, Hartford, CT, USA.""}, {'ForeName': 'Odion', 'Initials': 'O', 'LastName': 'Binitie', 'Affiliation': 'Department of Sarcoma, Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Choy', 'Affiliation': 'Department of Medical Oncology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Justin W', 'Initials': 'JW', 'LastName': 'Davis', 'Affiliation': ""Children's Oncology Group, Monrovia, CA, USA.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hayes-Jordan', 'Affiliation': 'Department of Surgery, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.'}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Kao', 'Affiliation': 'Department of Radiology, University of Iowa Carver College of Medicine, Iowa City, IA, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Kayton', 'Affiliation': ""Department of Surgery, Palm Beach Children's Hospital, St Mary's Medical Center, Florida Atlantic University, West Palm Beach, FL, USA.""}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Kessel', 'Affiliation': 'Imaging and Radiation Oncology Core Rhode Island, Lincoln, RI, USA.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Meyer', 'Affiliation': 'Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Million', 'Affiliation': 'Department of Radiation Oncology, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Okuno', 'Affiliation': 'Department of Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ostrenga', 'Affiliation': 'Department of Pharmacy, University of Mississippi Medical Center, Jackson, MS, USA.'}, {'ForeName': 'Marguerite T', 'Initials': 'MT', 'LastName': 'Parisi', 'Affiliation': ""Department of Radiology and Pediatrics, University of Washington School of Medicine and Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Pryma', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'R Lor', 'Initials': 'RL', 'LastName': 'Randall', 'Affiliation': 'Department of Orthopaedic Surgery, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Rosen', 'Affiliation': 'Department of Radiology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Schlapkohl', 'Affiliation': 'Department of Pediatrics, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Shulkin', 'Affiliation': ""Department of Diagnostic Imaging, St Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Smith', 'Affiliation': ""Department of Radiology and Medical Imaging, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Joel I', 'Initials': 'JI', 'LastName': 'Sorger', 'Affiliation': ""Department of Orthopaedic Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Terezakis', 'Affiliation': 'Department of Radiation Oncology, University of Minnesota, Masonic Cancer Center, Minneapolis, MN, USA.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': ""Department of Pediatrics, University of Washington School of Medicine and Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Sheri L', 'Initials': 'SL', 'LastName': 'Spunt', 'Affiliation': 'Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Dian', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Rush University Medical Center, Chicago, IL, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30325-9']
1694,32701847,Attention to breath sensations does not engage endogenous opioids to reduce pain.,"The endogenous opioidergic system is critically involved in the cognitive modulation of pain. Slow-breathing-based techniques are widely used nonpharmacological approaches to reduce pain. Yet, the active mechanisms of actions supporting these practices are poorly characterized. Growing evidence suggest that mindfulness-meditation, a slow-breathing technique practiced by nonreactively attending to breathing sensations, engages multiple unique neural mechanisms that bypass opioidergically mediated descending pathways to reduce pain. However, it is unknown whether endogenous opioids contribute to pain reductions produced by slow breathing. The present double-blind, placebo-controlled crossover study examined behavioral pain responses during mindfulness-meditation (n = 19), sham-mindfulness meditation (n = 20), and slow-paced breathing (n = 20) in response to noxious heat (49°C) and intravenous administration (0.15 mg/kg bolus + 0.1 mg/kg/hour maintenance infusion) of the opioid antagonist, naloxone, and placebo saline. Mindfulness significantly reduced pain unpleasantness ratings across both infusion sessions when compared to rest, but not pain intensity. Slow-paced breathing significantly reduced pain intensity and unpleasantness ratings during naloxone but not saline infusion. Pain reductions produced by mindfulness-meditation and slow-paced breathing were insensitive to naloxone when compared to saline administration. By contrast, sham-mindfulness meditation produced pain unpleasantness reductions during saline infusion but this effect was reversed by opioidergic antagonism. Sham-mindfulness did not lower pain intensity ratings. Self-reported ""focusing on the breath"" was identified as the operational feature particularly unique to the mindfulness-meditation and slow paced-breathing, but not sham-mindfulness meditation. Across all individuals, attending to the breath was associated with naloxone insensitive pain-relief. These findings provide evidence that slow breathing combined with attention to breath reduces pain independent of endogenous opioids.",2020,Slow-paced breathing significantly reduced pain intensity and unpleasantness ratings during naloxone but not saline infusion.,[],"['Slow-paced breathing', 'mindfulness-meditation (n = 19), sham-mindfulness meditation (n = 20), and slow-paced breathing (n = 20) in response to noxious heat (49°C) and intravenous administration (0.15 mg/kg bolus + 0.1 mg/kg/hour maintenance infusion) of the opioid antagonist, naloxone, and placebo saline', 'naloxone', 'placebo']","['Pain reductions', 'pain intensity ratings', 'pain unpleasantness ratings', 'pain unpleasantness reductions', 'pain intensity and unpleasantness ratings', 'behavioral pain responses']",[],"[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C4068886', 'cui_str': '0.15'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0027410', 'cui_str': 'Opioid receptor antagonist'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}]",,0.112843,Slow-paced breathing significantly reduced pain intensity and unpleasantness ratings during naloxone but not saline infusion.,"[{'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Wells', 'Affiliation': 'Departments of Neurology and.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Collier', 'Affiliation': 'Neurobiology and Anatomy.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Posey', 'Affiliation': 'Neurobiology and Anatomy.'}, {'ForeName': 'Afrayem', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': 'Psychiatry, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Auman', 'Affiliation': 'Neurobiology and Anatomy.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Strittmatter', 'Affiliation': 'School of Pharmacy, Wake Forest School of Medicine, Winston-Salem, NC, United States.'}, {'ForeName': 'Rossana', 'Initials': 'R', 'LastName': 'Magalhaes', 'Affiliation': 'Neurobiology and Anatomy.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Adler-Neal', 'Affiliation': 'Neurobiology and Anatomy.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'McHaffie', 'Affiliation': 'Neurobiology and Anatomy.'}, {'ForeName': 'Fadel', 'Initials': 'F', 'LastName': 'Zeidan', 'Affiliation': 'Department of Anesthesiology, University of California San Diego, San Diego, CA, United States.'}]",Pain,['10.1097/j.pain.0000000000001865']
1695,32709172,Bilateral Ultrasound-Guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block on Postoperative Analgesia after Total Abdominal Hysterectomy.,"BACKGROUND


Transversus abdominis plane (TAP) blocks provide postoperative pain relief after various abdominal surgeries. Recently, erector spinae plane (ESP) block has obtained vast attention due to its simplicity and usage in truncal procedures.
OBJECTIVES


This study aims to compare the ultrasound-guided bilateral ESP block versus bilateral TAP block on postoperative analgesia after open total abdominal hysterectomy.
STUDY DESIGN


A prospective, double-blinded, randomized, controlled, clinical trial.
SETTING


Zagazig University Hospitals.
METHODS


After ending of surgical procedure and before reversing of the muscle relaxant, 48 women were randomly allocated into 2 equal groups: erector spinae (ES) group received bilateral ultrasound-guided ESP block with 20 mL of bupivacaine 0.375% plus 5 ug/mL adrenaline (1:200000) in each side at the level of T9, and transversus abdominis (TA) group received bilateral ultrasound-guided TAP block with the same volume of bupivacaine plus adrenaline.
RESULTS


Visual Analog Scale scores at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours were statistically significantly lower in the ES group compared with the TA group. The time for requirement of first morphine was highly statistically significantly prolonged in the ES group (14.81 ± 3.52 hours) compared with the TA group (10.58 ± 2.35 hours). The total amount of morphine consumption in 24 hours postoperatively was statistically significantly decreased in the ES group; P = 0.01. Incidence of postoperative nausea and vomiting was higher but statistically insignificant in the TA group than the ES group. There were statistically significant numbers of unsatisfied patients (4) in the TA group compared with the ES group (no patient).
LIMITATIONS


Sensorial evaluation of patients was not performed because both blocks had been done under general anesthesia but did not affect outcome. Therefore we recommend further studies comparing between both blocks.
CONCLUSIONS


Bilateral ultrasound-guided ESP block provides more potent and longer postoperative analgesia with less morphine consumption than TAP block after open total abdominal hysterectomy.
KEY WORDS


Abdominal hysterectomy, transversus abdominis plane block, erector spinae plane block, postoperative analgesia.",2020,The total amount of morphine consumption in 24 hours postoperatively was statistically significantly decreased in the ES group; P = 0.01.,"['Zagazig University Hospitals', 'Postoperative Analgesia after Total Abdominal Hysterectomy', '48 women']","['Bilateral Ultrasound-Guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block', 'Abdominal hysterectomy, transversus abdominis plane block, erector spinae plane block, postoperative analgesia', 'Transversus abdominis plane (TAP) blocks', 'bupivacaine plus adrenaline', 'ultrasound-guided bilateral ESP block versus bilateral TAP block', 'erector spinae (ES) group received bilateral ultrasound-guided ESP block with 20 mL of bupivacaine 0.375% plus 5 ug/mL adrenaline (1:200000) in each side at the level of T9, and transversus abdominis (TA) group received bilateral ultrasound-guided TAP block']","['Incidence of postoperative nausea and vomiting', 'total amount of morphine consumption', 'time for requirement of first morphine', 'postoperative analgesia', 'Visual Analog Scale scores']","[{'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0404079', 'cui_str': 'Total abdominal hysterectomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0404077', 'cui_str': 'Abdominal hysterectomy'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",48.0,0.14806,The total amount of morphine consumption in 24 hours postoperatively was statistically significantly decreased in the ES group; P = 0.01.,"[{'ForeName': 'Alshaimaa Abdel Fattah', 'Initials': 'AAF', 'LastName': 'Kamel', 'Affiliation': 'Anaesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University, Alsharkia, Egypt.'}, {'ForeName': 'Olfat Abdelmoniem Ibrahem', 'Initials': 'OAI', 'LastName': 'Amin', 'Affiliation': 'Anaesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University, Alsharkia, Egypt.'}, {'ForeName': 'Mohamed Abdel Moniem', 'Initials': 'MAM', 'LastName': 'Ibrahem', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Zagazig University, Alsharkia, Egypt.'}]",Pain physician,[]
1696,32709173,Contrast Medium Volume Needed to Reach Anterior Epidural Space via the Kambin Triangle or Subpedicular Approach for Transforaminal Epidural Injection.,"BACKGROUND


Transforaminal (TF) lumbar injection is a commonly used minimally invasive intervention for management of chronic low back pain. TF injection can be performed using various approaches to inject the drug to the anterior epidural space (AES).
OBJECTIVES


To identify the volumes of contrast medium needed to reach the AES and other landmarks in the Kambin triangle (KB) and subpedicular (SP) approach of TF injection in patients with lumbosacral radicular pain.
STUDY DESIGN


Randomized controlled trial.
SETTING


Pain clinic and operating room of a tertiary care hospital.
METHODS


Seventy-five eligible patients were randomized to receive TF epidural injection either by SP (SP group; n = 38) or the KB (KB group; n = 37) approach under fluoroscopic guidance. After confirming the appropriate needle position, contrast medium was injected at 0.5 mL increments up to 2 mL under intermittent fluoroscopy. Contrast medium volumes needed to reach specific landmarks, that is, AES, medial to superior pedicle, medial to inferior pedicle, medial aspect of both the superior, and neural spread, were recorded. Following this, 4 mL of the drug (0.5% lidocaine 1 mL + methylprednisolone 80 mg + 1 mL normal saline solution) was injected. Patients were evaluated for Visual Analog Scale (VAS) and modified Oswestry Disability Questionnaire (MODQ) scores after epidural injections at 2 weeks, 1 month, and 2 months.
RESULTS


Average volume of contrast medium needed to reach AES was 1.10 ± 0.46 mL in the KB approach and 1.10 ± 0.38 mL in the SP approach. Contrast medium volume needed to reach other landmarks showed comparable results in both groups. AES was seen in 27.02% (10/37) patients in the KB group and 23.6% (9/38) patients in the SP group with 0.5 mL of contrast medium. This increased to 56.76% (21/37) and 77.7% (28/38) with 1 mL of contrast medium (P = 0.03, chi-square test). No anterior spread was seen even after 2 mL of contrast medium in 4 patients in the KB group and 2 patients in the SP group. Neural spread was seen in 100% of patients in the KB group after 0.5 mL of contrast medium, but in 34 (89.4%) patients in the SP group (P = 0.03, chi-square test). We did not note any contralateral spread. Short-term effectiveness in pain relief in terms of VAS for back pain and functional improvement in terms of MODQ score over time showed similar results in both groups. Intravascular needle puncture and needle paresthesia was comparable in both groups.
LIMITATIONS


Small follow-up duration is one the limitations of this study. Future studies will be needed to assess any long-term differences in outcome between approach methods. Also, use of intermittent fluoroscopy might have limited detection of intravascular injections of the contrast medium in comparison to the continuous fluoroscopy.
CONCLUSIONS


To conclude, our study revealed that average volume of contrast medium needed to reach AES and other landmarks were comparable with both approaches of TF injection.
KEY WORDS


Transforaminal injection, subpedicular approach, Kambin triangle approach, contrast medium spread, anterior epidural spread.",2020,No anterior spread was seen even after 2 mL of contrast medium in 4 patients in the KB group and 2 patients in the SP group.,"['patients with lumbosacral radicular pain', 'Seventy-five eligible patients', 'Pain clinic and operating room of a tertiary care hospital']","['KB (KB group; n = 37) approach under fluoroscopic guidance', 'TF injection', 'Transforaminal (TF) lumbar injection', 'TF epidural injection either by SP', 'lidocaine 1 mL + methylprednisolone 80 mg + 1 mL normal saline solution']","['pain relief', 'Neural spread', 'Visual Analog Scale (VAS) and modified Oswestry Disability Questionnaire (MODQ) scores', 'MODQ score', 'Intravascular needle puncture and needle paresthesia', 'AES']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450206', 'cui_str': 'Lumbosacral'}, {'cui': 'C0278147', 'cui_str': 'Radicular pain'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0242936', 'cui_str': 'Pain clinic'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}]","[{'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0560563', 'cui_str': 'Fluoroscopic guidance'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0021486', 'cui_str': 'Injections, Peridural'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442123', 'cui_str': 'Intravascular'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0014537', 'cui_str': 'Structure of epidural space'}]",75.0,0.0565945,No anterior spread was seen even after 2 mL of contrast medium in 4 patients in the KB group and 2 patients in the SP group.,"[{'ForeName': 'Babita', 'Initials': 'B', 'LastName': 'Ghai', 'Affiliation': 'Department of Anaesthesia, Post Graduate Institute of Medical Education and Research, Chandigarh.'}, {'ForeName': 'Amit Kumar', 'Initials': 'AK', 'LastName': 'Gupta', 'Affiliation': 'Departments of Orthopaedic Surgery, Anesthesia, and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Jeetinder Kaur', 'Initials': 'JK', 'LastName': 'Makkar', 'Affiliation': 'Department of Anesthesia and Intensive care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sarvdeep Singh', 'Initials': 'SS', 'LastName': 'Dhatt', 'Affiliation': 'Department of Orthopedics, Post Graduate Institute of Medical Education and Research, Chandigarh, India.'}]",Pain physician,[]
1697,32709189,"Re: Comparisons of Monopolar Lesion Volumes with Hypertonic Saline Solution in Radiofrequency Ablation: A Randomized, Double-Blind, Ex Vivo Study.",,2020,,['Radiofrequency Ablation'],['Hypertonic Saline Solution'],[],"[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}]",[],,0.71595,,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Provenzano', 'Affiliation': 'Pain Diagnostics and Interventional Care, Sewickley, Pennsylvania.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cosman', 'Affiliation': 'Cambridge Interventional, Burlington, MA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Wilsey', 'Affiliation': 'Smith-Nephew, Memphis, TN.'}]",Pain physician,[]
1698,32706658,Scheduled Telephone Support for Internet Cognitive Behavioral Therapy for Depression in Patients at Risk for Dropout: Pragmatic Randomized Controlled Trial.,"BACKGROUND


Therapist-supported, internet-delivered cognitive behavioral therapy (iCBT) is efficient in the treatment of depression. However, the optimal mode and intensity of therapist support remain to be identified. Scheduled telephone support (STS) may improve adherence and outcomes but, as it is time- and resource-consuming, should be reserved for patients for whom the usual support may be insufficient.
OBJECTIVE


This paper aims to reveal whether add-on STS for patients at risk of dropping out improves treatment adherence and symptoms in iCBT for depression.
METHODS


Among patients participating in an ongoing large observational routine clinical practice study of iCBT for depression delivered nationwide by Helsinki University Hospital (HUS-iCBT), those demonstrating a ≥14-day delay in initiation of treatment received invitations to this subsidiary STS study. A total of 100 consenting patients were randomly allocated to either HUS-iCBT as usual (control group, n=50) or HUS-iCBT plus add-on STS (intervention group, n=50). Proportions of those reaching midtreatment and treatment end point served as the primary outcome; secondary outcomes were change in Beck Depression Inventory (BDI)-measured depressive symptoms and time spent in treatment.
RESULTS


Add-on STS raised the proportion of patients reaching midtreatment compared with HUS-iCBT as usual (29/50, 58% vs 18/50, 36%; P=.045) and treatment end point (12/50, 24% vs 3/50, 6%; P=.02). Change in BDI score also favored add-on STS (3.63 points vs 1.1 points; P=.049), whereas duration of treatment did not differ.
CONCLUSIONS


Add-on STS enhances adherence and symptom improvement of patients at risk of dropping out of iCBT for depression in routine clinical practice.
TRIAL REGISTRATION


International Standard Randomised Controlled Trial Number (ISRCTN) 55123131; http://www.isrctn.com/ISRCTN55123131.",2020,"Change in BDI score also favored add-on STS (3.63 points vs 1.1 points; P=.049), whereas duration of treatment did not differ.
","['patients participating in an ongoing large observational routine clinical practice study of iCBT for depression delivered nationwide by Helsinki University Hospital (HUS-iCBT', '100 consenting patients']","['Scheduled Telephone Support for Internet Cognitive Behavioral Therapy', 'HUS-iCBT as usual (control group, n=50) or HUS-iCBT plus add-on STS (intervention', 'Scheduled telephone support (STS', 'Therapist-supported, internet-delivered cognitive behavioral therapy (iCBT']","['Change in BDI score', 'change in Beck Depression Inventory (BDI)-measured depressive symptoms and time spent in treatment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0019061', 'cui_str': 'Hemolytic uremic syndrome'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0019061', 'cui_str': 'Hemolytic uremic syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",100.0,0.220979,"Change in BDI score also favored add-on STS (3.63 points vs 1.1 points; P=.049), whereas duration of treatment did not differ.
","[{'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Pihlaja', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Hospital District of Helsinki and Uusimaa, Helsinki, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Lahti', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Jari Olavi', 'Initials': 'JO', 'LastName': 'Lipsanen', 'Affiliation': 'Department of Psychology and Logopedics, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Ritola', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Hospital District of Helsinki and Uusimaa, Helsinki, Finland.'}, {'ForeName': 'Eero-Matti', 'Initials': 'EM', 'LastName': 'Gummerus', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Hospital District of Helsinki and Uusimaa, Helsinki, Finland.'}, {'ForeName': 'Jan-Henry', 'Initials': 'JH', 'LastName': 'Stenberg', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Hospital District of Helsinki and Uusimaa, Helsinki, Finland.'}, {'ForeName': 'Grigori', 'Initials': 'G', 'LastName': 'Joffe', 'Affiliation': 'Department of Psychiatry, University of Helsinki and Helsinki University Hospital, Hospital District of Helsinki and Uusimaa, Helsinki, Finland.'}]",Journal of medical Internet research,['10.2196/15732']
1699,32706659,Predictors of Self-Determined Module Choice in a Web-Based Computer-Tailored Diet and Physical Activity Intervention: Secondary Analysis of Data From a Randomized Controlled Trial.,"BACKGROUND


Tailoring an online intervention to participant preferences (eg, by giving participants a choice which modules to follow) may increase engagement in the intervention, motivation for behavioral change, and possibly intervention effects. So far, little is known about what characteristics predict these module choices. Filling this knowledge gap is useful for optimizing program engagement.
OBJECTIVE


We investigated participant choice for a dietary and/or physical activity (PA) promotion module in our web-based computer-tailored intervention based on self-determination theory (SDT) and motivational interviewing (MI). Furthermore, we investigated which demographic characteristics, current behavior, psychosocial constructs and constructs from SDT and MI, and program-related variables such as advice on which module to follow were associated with these choices.
METHODS


Observational data were used from the randomized controlled trial MyLifestyleCoach of participants who were randomized into the intervention condition, completed the baseline questionnaire, and made a module choice in the opening session of the intervention. Here, they received advice on their own dietary and PA behavior. At the session's end, they chose which lifestyle modules they would like to follow (both, diet, PA, or no module). Measurements included demographic information; self-reported diet and PA; and several psychosocial, SDT, and MI constructs. In total, data from 619 Dutch adults (59.6% women; mean age was 51.9 [SD 13.5] years) were analyzed. A stepwise multinomial logistic regression analysis was conducted to investigate which characteristics are related to module choice; the diet module served as reference category as almost everyone was advised to follow this module.
RESULTS


Of this sample, 54.8% (339/619) chose to do both the diet and PA module, 25.4% (157/619) chose to follow the diet module, 17.8% (110/619) preferred to follow no module, and 2.1% (13/619) chose to do the PA module only. Furthermore, it was found that older people, those who consumed more fruit, and those who scored lower on importance to change their current diet were more likely to choose no module compared to the diet module. People who had more motivation to change their current PA and those who received strong advice compared with slight advice to follow the diet module were more likely to choose both modules compared with the diet module only.
CONCLUSIONS


The results show that more than half of the sample was interested in following both the diet and PA module in this online lifestyle intervention. Several characteristics were found to be related to module choice. A future challenge is to examine how this knowledge can be used to improve future interventions, such as tailoring (messages or content) on specific groups or examining where and how MI could be used to motivate people to make a certain module choice.
TRIAL REGISTRATION


Netherlands Trial Register NL7333; https://www.trialregister.nl/trial/7333.",2020,"Furthermore, it was found that older people, those who consumed more fruit, and those who scored lower on importance to change their current diet were more likely to choose no module compared to the diet module.","['619 Dutch adults (59.6% women; mean age was 51.9 [SD 13.5] years) were analyzed', 'People who had more motivation to change their current PA and those who received']","['Self-Determined Module Choice in a Web-Based Computer-Tailored Diet and Physical Activity Intervention', 'dietary and/or physical activity (PA) promotion module', 'strong advice', 'self-determination theory (SDT) and motivational interviewing (MI']","['demographic information; self-reported diet and PA; and several psychosocial, SDT, and MI constructs']","[{'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517559', 'cui_str': '13.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036595', 'cui_str': 'Self Determination'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}]",619.0,0.0446689,"Furthermore, it was found that older people, those who consumed more fruit, and those who scored lower on importance to change their current diet were more likely to choose no module compared to the diet module.","[{'ForeName': 'Juul M J', 'Initials': 'JMJ', 'LastName': 'Coumans', 'Affiliation': 'Department of Health Psychology, Faculty of Psychology, Open University of the Netherlands, Heerlen, Netherlands.'}, {'ForeName': 'Catherine A W', 'Initials': 'CAW', 'LastName': 'Bolman', 'Affiliation': 'Department of Health Psychology, Faculty of Psychology, Open University of the Netherlands, Heerlen, Netherlands.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Oenema', 'Affiliation': 'Department of Health Promotion, Caphri, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Lechner', 'Affiliation': 'Department of Health Psychology, Faculty of Psychology, Open University of the Netherlands, Heerlen, Netherlands.'}]",Journal of medical Internet research,['10.2196/15024']
1700,32706852,Mixed-Methods Randomized Evaluation of FAMS: A Mobile Phone-Delivered Intervention to Improve Family/Friend Involvement in Adults' Type 2 Diabetes Self-Care.,"BACKGROUND


Family and friends have both helpful and harmful effects on adults' diabetes self-management. Family-focused Add-on to Motivate Self-care (FAMS) is a mobile phone-delivered intervention designed to improve family/friend involvement, self-efficacy, and self-care via monthly phone coaching, texts tailored to goals, and the option to invite a support person to receive texts.
PURPOSE


We sought to evaluate how FAMS was received by a diverse group of adults with Type 2 diabetes and if FAMS improved diabetes-specific family/friend involvement (increased helpful and reduced harmful), diabetes self-efficacy, and self-care (diet and physical activity). We also assessed if improvements in family/friend involvement mediated improvements in self-efficacy and self-care.
METHODS


Participants were prospectively assigned to enhanced treatment as usual (control), an individualized text messaging intervention alone, or the individualized text messaging intervention plus FAMS for 6 months. Participants completed surveys at baseline, 3 and 6 months, and postintervention interviews. Between-group and multiple mediator analyses followed intention-to-treat principles.
RESULTS


Retention, engagement, and fidelity were high. FAMS was well received and helped participants realize the value of involving family/friends in their care. Relative to control, FAMS participants had improved family/friend involvement, self-efficacy, and diet (but not physical activity) at 3 and 6 months (all ps < .05). Improvements in family/friend involvement mediated effects on self-efficacy and diet for FAMS participants but not for the individualized intervention group.
CONCLUSIONS


The promise of effectively engaging patients' family and friends lies in sustained long-term behavior change. This work represents a first step toward this goal by demonstrating how content targeting helpful and harmful family/friend involvement can drive short-term effects.
TRIAL REGISTRATION NUMBER


NCT02481596.",2020,"Improvements in family/friend involvement mediated effects on self-efficacy and diet for FAMS participants but not for the individualized intervention group.
","['Participants', ""Adults' Type 2 Diabetes Self-Care""]","['FAMS', 'enhanced treatment as usual (control), an individualized text messaging intervention alone, or the individualized text messaging intervention plus FAMS', 'Mobile Phone-Delivered Intervention']","['self-efficacy and self-care', 'family/friend involvement, self-efficacy, and diet', 'Retention, engagement, and fidelity', 'diabetes-specific family/friend involvement (increased helpful and reduced harmful), diabetes self-efficacy, and self-care (diet and physical activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}]","[{'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0079382', 'cui_str': 'Friend'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0296122,"Improvements in family/friend involvement mediated effects on self-efficacy and diet for FAMS participants but not for the individualized intervention group.
","[{'ForeName': 'Lindsay S', 'Initials': 'LS', 'LastName': 'Mayberry', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine and Public Health, Vanderbilt University Medical Center, Nashville, TN 37203, USA.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Berg', 'Affiliation': 'Department of Psychology, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Greevy', 'Affiliation': 'Vanderbilt Center for Diabetes Translation Research, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Lyndsay A', 'Initials': 'LA', 'LastName': 'Nelson', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine and Public Health, Vanderbilt University Medical Center, Nashville, TN 37203, USA.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Bergner', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine and Public Health, Vanderbilt University Medical Center, Nashville, TN 37203, USA.'}, {'ForeName': 'Kenneth A', 'Initials': 'KA', 'LastName': 'Wallston', 'Affiliation': 'Vanderbilt Center for Diabetes Translation Research, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Kryseana J', 'Initials': 'KJ', 'LastName': 'Harper', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine and Public Health, Vanderbilt University Medical Center, Nashville, TN 37203, USA.'}, {'ForeName': 'Tom A', 'Initials': 'TA', 'LastName': 'Elasy', 'Affiliation': 'Department of Medicine, Division of General Internal Medicine and Public Health, Vanderbilt University Medical Center, Nashville, TN 37203, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa041']
1701,32707289,Effect of an abdominal hypopressive technique programme on pelvic floor muscle tone and urinary incontinence in women: a randomised crossover trial.,"OBJECTIVES


To test the effect of a structured abdominal hypopressive technique (AHT) programme on pelvic floor muscle (PFM) tone and urinary incontinence (UI) in women.
DESIGN


Crossover trial with random assignment of women to one of two groups: Group 1 (AHT followed by rest) and Group 2 (rest followed by AHT).
SETTING


Two cultural centres in Madrid, Spain.
PARTICIPANTS


Women aged 20-65 years.
INTERVENTIONS


Two months of supervised AHT exercises compared with 2 months of rest.
MAIN OUTCOME MEASURES


Variation in PFM tone and score on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)].
RESULTS


Forty-two women were randomised to two groups (both n=21). No sequence or period effect was noted. The mean difference in PFM tone after the 2-month AHT programme was 59g/cm² [95% confidence interval (CI) 37 to 82]; the between-group difference was 83g/cm² (95% CI 50 to 116; P<0.001). After 2 months, the between-group difference in the ICIQ-SF score was 3.3 points (P<0.001). The majority of participants reported improved body image and sense of well-being.
CONCLUSIONS


A structured 2-month AHT programme for women showed short-term benefits in PFM tone and UI. In addition, study participants reported improved body image and sense of well-being, and programme satisfaction, as demonstrated by questionnaire at the end of the intervention period. Further research is needed to test the long-term effects and effectiveness of AHT compared with other PFM exercises. ClinicalTrials.gov Identifier NCT0221241.",2020,"After 2 months, the between-group difference in the ICIQ-SF score was 3.3 points (P<0.001).","['women', 'women to one of two groups', 'Forty-two women', 'Two cultural centres in Madrid, Spain', 'Women aged 20-65 years']","['Group 1 (AHT followed by rest) and Group 2 (rest followed by AHT', 'structured abdominal hypopressive technique (AHT) programme', 'supervised AHT exercises', 'AHT', 'abdominal hypopressive technique programme']","['pelvic floor muscle tone and urinary incontinence', 'ICIQ-SF score', 'PFM tone', 'pelvic floor muscle (PFM) tone and urinary incontinence (UI', 'body image and sense of well-being, and programme satisfaction', 'Variation in PFM tone and score on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF', 'body image and sense of well-being']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}]",42.0,0.187985,"After 2 months, the between-group difference in the ICIQ-SF score was 3.3 points (P<0.001).","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Soriano', 'Affiliation': 'Universidad Camilo José Cela, Madrid, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'González-Millán', 'Affiliation': 'Universidad Camilo José Cela, Madrid, Spain.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Álvarez Sáez', 'Affiliation': 'Maio Medical Centre, Vigo, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Curbelo', 'Affiliation': 'Universidad Camilo José Cela, Madrid, Spain; Instituto de Salud Musculoesquelética, Madrid, Spain.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Carmona', 'Affiliation': 'Universidad Camilo José Cela, Madrid, Spain; Instituto de Salud Musculoesquelética, Madrid, Spain. Electronic address: loreto.carmona@inmusc.eu.'}]",Physiotherapy,['10.1016/j.physio.2020.02.004']
1702,32707294,Effects of stress on 6- and 7-year-old children's emotional memory differs by gender.,"Understanding effects of emotional valence and stress on children's memory is important for educational and legal contexts. This study disentangled the effects of emotional content of to-be-remembered information (i.e., items differing in emotional valence and arousal), stress exposure, and associated cortisol secretion on children's memory. We also examined whether girls' memory is more affected by stress induction. A total of 143 6- and 7-year-old children were randomly allocated to the Trier Social Stress Test for Children (n = 103) or a control condition (n = 40). At 25 min after stressor onset, children incidentally encoded 75 objects varying in emotional valence (crossed with arousal) together with neutral scene backgrounds. We found that response bias corrected memory was worse for low-arousing negative items than for neutral and positive items, with the latter two categories not being different from each other. Whereas boys' memory was largely unaffected by stress, girls in the stress condition showed worse memory for negative items, especially the low-arousing ones, than girls in the control condition. Girls, compared with boys, reported higher subjective stress increases following stress exposure and had higher cortisol stress responses. Whereas a higher cortisol stress response was associated with better emotional memory in girls in the stress condition, boys' memory was not associated with their cortisol secretion. Taken together, our study suggests that 6- and 7-year-old children, more so girls, show memory suppression for negative information. Girls' memory for negative information, compared with that of boys, is also more strongly modulated by stress experience and the associated cortisol response.",2020,A total of 143 6- and 7-year-old children were randomly allocated to the Trier Social Stress Test for Children (n = 103) or a control condition (n = 40).,"[""6- and 7-year-old children's emotional memory differs by gender"", 'A total of 143 6- and 7-year-old children', ""children's memory""]",['Trier Social Stress Test for Children (n\xa0=\xa0103) or a control condition'],"['cortisol response', 'cortisol stress responses', 'cortisol stress response']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517573', 'cui_str': '143'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",143.0,0.0372713,A total of 143 6- and 7-year-old children were randomly allocated to the Trier Social Stress Test for Children (n = 103) or a control condition (n = 40).,"[{'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Raffington', 'Affiliation': 'Center for Lifespan Psychology, Max Planck Institute for Human Development, 14195 Berlin, Germany; Department of Psychology, University of Texas at Austin, Austin, TX 78712, USA.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Falck', 'Affiliation': 'Center for Lifespan Psychology, Max Planck Institute for Human Development, 14195 Berlin, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Heim', 'Affiliation': 'Institute of Medical Psychology, Charité - Universitäts medizin Berlin, 10117 Berlin, Germany; Department of Biobehavioral Health, Pennsylvania State University, University Park, PA 16802, USA.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Mather', 'Affiliation': 'Leonard Davis School of Gerontology, University of Southern California, Los Angeles, CA 90089, USA.'}, {'ForeName': 'Yee Lee', 'Initials': 'YL', 'LastName': 'Shing', 'Affiliation': 'Center for Lifespan Psychology, Max Planck Institute for Human Development, 14195 Berlin, Germany; Institute of Psychology, Goethe-Universität Frankfurt, 60323 Frankfurt am Main, Germany. Electronic address: shing@psych.uni-frankfurt.de.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2020.104924']
1703,32707332,An invited commentary: The efficacy of transversus abdominis plane block with or without dexmedetomidine for postoperative analgesia in renal transplantation. A randomized controlled trial.,,2020,,['renal transplantation'],['transversus abdominis plane block with or without dexmedetomidine'],[],"[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]",[],,0.168804,,"[{'ForeName': 'Yuhang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, Guizhou, 563000, China. Electronic address: yulang5301@sina.com.'}, {'ForeName': 'Taowu', 'Initials': 'T', 'LastName': 'Gong', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University, Guizhou, 563000, China. Electronic address: chenmingaini1232@sina.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.07.008']
1704,32712307,A 24-month randomized controlled trial on the success rates of restoring untreated and SDF-treated dentine caries lesions in primary teeth with the ART approach.,"OBJECTIVE


To compare the success rates of restoring untreated and SDF-treated dentine caries lesions in primary teeth with atraumatic restorative treatment (ART) approach.
METHOD


Cavitated dentine caries lesions in preschool children were randomly allocated to two groups to be applied with either 38% silver diamine fluoride (SDF) solution or tonic water (control) ten weeks before being restored with the ART approach. Status of the restorations were assessed every six months by a blinded independent examiner. Multilevel logistic regression and multilevel survival analyses were conducted to assess the restoration success rates.
RESULTS


A total of 194 children (SDF group, 101; control group, 93) were included, with 260 and 249 ART restorations placed in the SDF and the control groups, respectively. At 24-month follow-up, 88 (87 %) and 84 (90 %) children remained in the SDF and the control groups, respectively. There was no significant difference between the ART restoration success rates of the two study groups (p > 0.05). The success rate of ART restorations was associated with the class of restorations. Class I restorations had the highest success rate (∼50 %), followed by Class V (∼35 %), Class II (∼15 %) and Class III (<10 %). Besides, the mean time used to place an ART restoration in a SDF-treated caries lesion was shorter than that in untreated lesion (4.8 vs. 5.1 min, p = 0.006).
CONCLUSION


Prior SDF application does not significantly affect the success rate of ART restorations placed in primary teeth. Besides, it is faster to place ART restorations in caries lesions that have been previously treated with SDF.
CLINICAL SIGNIFICANCE


Prior application of silver diamine fluoride solution on cavitated dentine caries lesions in primary teeth can shorten the average time required to place an ART restoration while not jeopardizing the success rate of the restorations.",2020,There was no significant difference between the ART restoration success rates of the two study groups (p > 0.05).,"['Cavitated dentine caries lesions in preschool children', 'primary teeth with atraumatic restorative treatment (ART) approach', '194 children (SDF group, 101; control group, 93) were included, with 260 and 249 ART restorations placed in the SDF and the control groups, respectively', 'cavitated dentine caries lesions in primary teeth', 'primary teeth with the ART approach']","['38% silver diamine fluoride (SDF) solution or tonic water (control) ten weeks before being restored with the ART approach', 'restoring untreated and SDF-treated dentine caries lesions', 'silver diamine fluoride solution']","['ART restoration success rates', 'highest success rate', 'success rates', 'mean time used to place an ART restoration in a SDF-treated caries lesion', 'success rate of ART restorations', 'success rate']","[{'cui': 'C0266846', 'cui_str': 'Dental caries extending into dentin'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517669', 'cui_str': '260'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0452449', 'cui_str': 'Tonic water'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0266846', 'cui_str': 'Dental caries extending into dentin'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]",194.0,0.0638187,There was no significant difference between the ART restoration success rates of the two study groups (p > 0.05).,"[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'May Chun Mei', 'Initials': 'MCM', 'LastName': 'Wong', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chun Chu', 'Initials': 'CC', 'LastName': 'Hung', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Linlu', 'Initials': 'L', 'LastName': 'Dai', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Edward Chin Man', 'Initials': 'ECM', 'LastName': 'Lo', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong, China. Electronic address: edward-lo@hku.hk.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103435']
1705,32714001,Evaluation of a Novel Trocar-Site Closure Device in Laparoscopic Surgery.,"Background and Objectives


We evaluated the effectiveness and safety of EZ-Close TM  compared to those of hand suture for trocar-site closure according to obesity.
Methods


Fifty-four cases of laparoscopic colorectal surgery were enrolled. For the same patient, the right port site was closed using EZ-Close TM  and left port site was closed by hand suture among cases with port-site diameter ≥10 mm. Cases switched to use of a conventional fascial closure device or with closure time 120 s were considered failures. Closure time was analyzed according to body mass index (BMI) and abdominal wall thickness (AWT).
Results


The mean closure time was significantly shorter with EZ-Close TM  than with hand suture (87.9 ± 21.0 vs. 128.0 ± 59.0 s,  p  < 0.001). The number of failure cases was significantly lower with EZ-Close TM  than with hand suture (7 vs. 27,  p  < 0.001). The closure time of EZ-Close TM  was significantly shorter than that of hand suture in patients with BMI ≥ 25 and < 27 kg/m 2  (n = 15, 85.9 ± 19.8 vs. 135.6 ± 67.9 s,  p  < 0.014) and ≥ 27 kg/m 2  (n = 13, 85.1 ± 18.4 vs. 150.2 ± 70.6 s,  p  < 0.010). With respect to AWT, the closure time of EZ-Close TM  was significantly shorter than that of hand suture in patients with AWT ≥ 20 and < 26 mm (n = 12, 81.1 ± 11.5 vs. 142.3 ± 83.7 s,  p  = 0.023) and ≥ 26 mm (n = 17, 85.6 ± 22.6 vs. 160.2 ± 55.5,  p  < 0.001). No infection and herniation were detected in both trocar sites during the follow-up period (median 20.4 months).
Conclusion


EZ-Close TM  could provide time efficiency in trocar-site closure, especially in obese patients.",2020,"No infection and herniation were detected in both trocar sites during the follow-up period (median 20.4 months).
","['obese patients', 'Methods\n\n\nFifty-four cases of laparoscopic colorectal surgery were enrolled', 'Laparoscopic Surgery']","['Novel Trocar-Site Closure Device', 'conventional fascial closure device', 'EZ-Close TM']","['number of failure cases', 'mean closure time', 'closure time of EZ-Close TM', 'No infection and herniation', 'Closure time', 'body mass index (BMI) and abdominal wall thickness (AWT']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0587267', 'cui_str': 'Closed'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C2712105', 'cui_str': 'Absence of signs and symptoms of infection'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0836916', 'cui_str': 'Abdominal wall structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",,0.0446081,"No infection and herniation were detected in both trocar sites during the follow-up period (median 20.4 months).
","[{'ForeName': 'Youngbae', 'Initials': 'Y', 'LastName': 'Jeon', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Soohwa', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Department of Biomedical Engineering, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Kyoung-Won', 'Initials': 'KW', 'LastName': 'Han', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Dong-Hyuk', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Biomedical Engineering, Gachon University College of Medicine, Incheon, Republic of Korea.'}, {'ForeName': 'Jeong-Heum', 'Initials': 'JH', 'LastName': 'Baek', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea.'}]",JSLS : Journal of the Society of Laparoendoscopic Surgeons,['10.4293/JSLS.2020.00033']
1706,32717295,Effects of Nicotine on Task Switching and Distraction in Non-smokers. An fMRI Study.,"Nicotine improves sustained attention and reduces distractor interference, promoting cognitive stability. While stable performance may be beneficial in some situations, others require flexible updating of task demands. Frontoparietal networks, basal ganglia and thalamus contribute to an optimal balance of stable and flexible performance. We aimed to test how the cholinergic agonist nicotine modulates this balance and used an ongoing visual task including switch and distractor trials to gauge cognitive flexibility and stability respectively. Young healthy non-smokers (n = 39) received either a 7 mg transdermal nicotine or placebo patch in a double-blind, within-subject design one hour prior to performing the task in a 3 T MR scanner. Nicotine enhanced response times in all task conditions but did not significantly impact distractor or switch costs. Neurally, there was no significant nicotine induced modulation of distractor- or switch-related activity on group level. However, a brain-behaviour correlation analysis revealed that the nicotine-induced alterations of distractor costs correlated positively with distractor-related neural activity in the right intraparietal sulcus and the right pulvinar nucleus of the thalamus. We suggest that a nicotinic contribution to balancing stability and flexibility is weak in young healthy non-smokers. The brain-behaviour correlations imply that if nicotine reduces distractor interference, the modulation is found in thalamic-parietal networks.",2020,"The brain-behaviour correlations imply that if nicotine reduces distractor interference, the modulation is found in thalamic-parietal networks.","['young healthy non-smokers', 'non-smokers', 'Young healthy non-smokers (n=39']","['Nicotine', 'cholinergic agonist nicotine', 'transdermal nicotine or placebo patch', 'nicotine']","['task switching and distraction', 'distractor costs', 'distractor interference', 'sustained attention and reduces distractor interference, promoting cognitive stability', 'impact distractor or switch costs']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0242894', 'cui_str': 'Cholinergic Agonist'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",,0.0408686,"The brain-behaviour correlations imply that if nicotine reduces distractor interference, the modulation is found in thalamic-parietal networks.","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Ahrens', 'Affiliation': 'Biological Psychology, Department of Psychology, School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany.'}, {'ForeName': 'Christiane M', 'Initials': 'CM', 'LastName': 'Thiel', 'Affiliation': 'Biological Psychology, Department of Psychology, School of Medicine and Health Sciences, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany; Cluster of Excellence ""Hearing4all"", Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany; Research Center Neurosensory Science, Carl von Ossietzky Universität Oldenburg, Oldenburg, Germany. Electronic address: christiane.thiel@uni-oldenburg.de.'}]",Neuroscience,['10.1016/j.neuroscience.2020.07.029']
1707,32718193,Detecting asthma exacerbations using daily home monitoring and machine learning.,"OBJECTIVE


Acute exacerbations contribute significantly to the morbidity of asthma. Recent studies have shown that early detection and treatment of asthma exacerbations leads to improved outcomes. We aimed to develop a machine learning algorithm to detect severe asthma exacerbations using easily available daily monitoring data.
METHODS


We analyzed daily peak expiratory flow and symptom scores recorded by participants in the SAKURA study (NCT00839800), an international multicentre randomized controlled trial comparing budesonide/formoterol as maintenance and reliever therapy versus budesonide/formoterol maintenance plus terbutaline as reliever, in adults with persistent asthma. The dataset consisted of 728,535 records of daily monitoring data in 2010 patients, with 576 severe exacerbation events. Data post-processing techniques included normalization, standardization, calculation of differences or slopes over time and the use of smoothing filters. Principal components analysis was used to reduce the large number of derived variables to a smaller number of linearly independent components. Logistic regression, decision tree, naïve Bayes, and perceptron algorithms were evaluated. Model accuracy was assessed using stratified cross-validation. The primary outcome was the detection of exacerbations on the same day or up to three days in the future.
RESULTS


The best model used logistic regression with input variables derived from post-processed data using principal components analysis. This had an area under the receiver operating characteristic curve of 0.85, with a sensitivity of 90% and specificity of 83% for severe asthma exacerbations.
CONCLUSION


Asthma exacerbations may be detected using machine learning algorithms applied to daily self-monitoring of peak expiratory flow and asthma symptoms.",2020,"This had an area under the receiver operating characteristic curve of 0.85, with a sensitivity of 90% and specificity of 83% for severe asthma exacerbations.","['adults with persistent asthma', '2010 patients, with 576 severe exacerbation events']","['budesonide/formoterol maintenance plus terbutaline', 'daily home monitoring and machine learning', 'budesonide/formoterol', 'machine learning algorithm']","['daily peak expiratory flow and symptom scores', 'detection of exacerbations', 'morbidity of asthma', 'peak expiratory flow and asthma symptoms', 'Model accuracy']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039542', 'cui_str': 'Terbutaline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}]",,0.440755,"This had an area under the receiver operating characteristic curve of 0.85, with a sensitivity of 90% and specificity of 83% for severe asthma exacerbations.","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Zhang', 'Affiliation': 'Department of Computer Engineering (INFO), INSA Rennes, Rennes, France.'}, {'ForeName': 'Leandro L', 'Initials': 'LL', 'LastName': 'Minku', 'Affiliation': 'School of Computer Science, University of Birmingham, UK.'}, {'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Gonem', 'Affiliation': 'Department of Respiratory Medicine, Nottingham City Hospital, Nottingham, UK.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1802746']
1708,32719050,Online supplementation for teaching evidence-based medicine: feasibility of a randomised-controlled trial.,"BACKGROUND AND OBJECTIVES


As teaching technology advances, medical education is increasingly using digital mediums and exploring instructional models such as the flipped classroom and blended learning courses, where the in-class taught sessions are more groups on content delivered before class. Early evidence suggests lectures and foundational material can be equally provided online, but we have low-quality research to be convinced. We aim to test and develop an online evidence-based teaching resource that seeks to improve the availability and scalability of evidence-based medicine (EBM) learning tools. We evaluate the feasibility of a study design that could test for changes in academic performance in EBM skills using an online supplement.
METHODS


Mixed-methods feasibility study of a randomised controlled trial (RCT) in an undergraduate medical student cohort.
RESULTS


Of a small cohort (n=34), eight participants agreed to randomisation and completed the study. No study participant completed the EBM supplementary course in full. Students report time-management as a significant barrier in participation, and all aspects of the study and communications should be delivered with efficiency a key consideration.
CONCLUSION


Randomising students to an online EBM supplement within a medical school programme presents challenges of recruitment and student motivation, but the study design is potentially feasible.",2020,We aim to test anddevelop an online evidence-based teaching resource that seeks to improve theavailability and scalability of evidence-based medicine (EBM) learning tools.,"['undergraduate medical student cohort', 'Of a small cohort (n=34']",['Online supplementation'],[],"[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]",[],,0.153404,We aim to test anddevelop an online evidence-based teaching resource that seeks to improve theavailability and scalability of evidence-based medicine (EBM) learning tools.,"[{'ForeName': 'Marcy C', 'Initials': 'MC', 'LastName': 'McCall', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK marcy.mccall@phc.ox.ac.uk.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Fanshawe', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McCartney', 'Affiliation': 'Medical Sciences Division, Oxford University, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Damion', 'Initials': 'D', 'LastName': 'Young', 'Affiliation': 'Medical Sciences Division, Oxford University, Oxford, Oxfordshire, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nunan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Heneghan', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, UK.'}]",BMJ evidence-based medicine,['10.1136/bmjebm-2020-111372']
1709,32719355,Preferential inhibition of adaptive immune system dynamics by glucocorticoids in patients after acute surgical trauma.,"Glucocorticoids (GC) are a controversial yet commonly used intervention in the clinical management of acute inflammatory conditions, including sepsis or traumatic injury. In the context of major trauma such as surgery, concerns have been raised regarding adverse effects from GC, thereby necessitating a better understanding of how GCs modulate the immune response. Here we report the results of a randomized controlled trial (NCT02542592) in which we employ a high-dimensional mass cytometry approach to characterize innate and adaptive cell signaling dynamics after a major surgery (primary outcome) in patients treated with placebo or methylprednisolone (MP). A robust, unsupervised bootstrap clustering of immune cell subsets coupled with random forest analysis shows profound (AUC = 0.92, p-value = 3.16E-8) MP-induced alterations of immune cell signaling trajectories, particularly in the adaptive compartments. By contrast, key innate signaling responses previously associated with pain and functional recovery after surgery, including STAT3 and CREB phosphorylation, are not affected by MP. These results imply cell-specific and pathway-specific effects of GCs, and also prompt future studies to examine GCs' effects on clinical outcomes likely dependent on functional adaptive immune responses.",2020,"A robust, unsupervised bootstrap clustering of immune cell subsets coupled with random forest analysis shows profound (AUC = 0.92, p-value = 3.16E-8) MP-induced alterations of immune cell signaling trajectories, particularly in the adaptive compartments.","['patients treated with', 'patients after acute surgical trauma']","['Glucocorticoids (GC', 'placebo or methylprednisolone (MP', 'glucocorticoids']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]",[],,0.170748,"A robust, unsupervised bootstrap clustering of immune cell subsets coupled with random forest analysis shows profound (AUC = 0.92, p-value = 3.16E-8) MP-induced alterations of immune cell signaling trajectories, particularly in the adaptive compartments.","[{'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Ganio', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Stanley', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Viktoria', 'Initials': 'V', 'LastName': 'Lindberg-Larsen', 'Affiliation': 'The Lundbeck Foundation Center for Fast-track Hip and Knee replacement, Copenhagen, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Einhaus', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Tsai', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Verdonk', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Culos', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Gahemi', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Rumer', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ina A', 'Initials': 'IA', 'LastName': 'Stelzer', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Dyani', 'Initials': 'D', 'LastName': 'Gaudilliere', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Department of Surgery, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Tsai', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Fallahzadeh', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Choisy', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': 'Section of Surgical Pathophysiology 7621, Rigshospitalet, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Aghaeepour', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Angst', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Brice', 'Initials': 'B', 'LastName': 'Gaudilliere', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, School of Medicine, Stanford University, Stanford, CA, USA. gbrice@stanford.edu.'}]",Nature communications,['10.1038/s41467-020-17565-y']
1710,32739331,Which brand should be more nervous about nutritional information disclosure: McDonald's or Subway?,"This study examines the health halo and horn effects in the context of two fast food brands commonly associated with healthy and unhealthy food (i.e., Subway and McDonald's). Health halo is consumers' tendency to overestimate the healthiness of certain food categories or items based on a single claim, whereas health horn is the tendency to underestimate it. Specifically, we investigated the moderating effects of nutritional information disclosure and dietary restraint on consumers' behavioral intentions. Two items from the McDonald's and Subway menus each served as stimuli. They represented health halo confirmation (Roast Chicken sandwich) or disconfirmation (Italian Spicy sandwich) and health horn confirmation (Big Mac burger) or disconfirmation (McSpicy Cajun Burger). This study employed a 2 (nutritional information: present vs. absent) × 4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) and 2 (dietary restraint: restrained eaters vs. unrestrained eaters) × 4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) mixed factorial design. Participants were randomly assigned to one of two experimental conditions (nutritional information: present vs. absent) and presented with all four menu items. There was a decrease in behavioral intentions toward all menu items except the one representing health horn disconfirmation. In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich). The findings not only delineate the different practices companies adopt but also underscore the importance of nutritional information disclosure in helping consumers make healthier food choices.",2020,"In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich).","[""consumers' behavioral intentions""]","[""absent)\u202f×\u202f4 (menu item type: a health halo or horn associated with Subway or McDonald's menu items with favorable and unfavorable nutritional profiles) and 2 (dietary restraint: restrained eaters vs. unrestrained eaters"", 'nutritional information disclosure and dietary restraint', ""health halo or horn associated with Subway or McDonald's menu items""]",['behavioral intentions'],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0181278', 'cui_str': 'Halo brace'}, {'cui': 'C0019939', 'cui_str': 'Horns'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0524709', 'cui_str': 'Subways'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0035260', 'cui_str': 'Physical restraint'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",,0.0167676,"In particular, behavioral intentions were most substantially weakened for the item that entailed a health halo disconfirmation (Italian Spicy sandwich).","[{'ForeName': 'Meeyoung', 'Initials': 'M', 'LastName': 'Joe', 'Affiliation': 'Foodservice Management Lab, Symbiotic Life Tech Research Institute, Yonsei University, Samsung Hall 505, Yonseiro 50, Seoul, Seodaemun-gu, 03722, Republic of Korea. Electronic address: cookie22@yonsei.ac.kr.'}, {'ForeName': 'Seoki', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'School of Hospitality Management, The Pennsylvania State University, 217 Mateer Building University Park, PA, 16802, USA. Electronic address: leeseoki@psu.edu.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Ham', 'Affiliation': 'Dept. of Food & Nutrition, Foodservice Management Lab, Symbiotic Life Tech Research Institute, Yonsei University, Samsung Hall 510, Yonseiro 50, Seoul, Seodaemun-gu, 03722, Republic of Korea. Electronic address: sham2@yonsei.ac.kr.'}]",Appetite,['10.1016/j.appet.2020.104805']
1711,32715482,"Effect of novel short-arm human centrifugation-induced gravitational gradients upon cardiovascular responses, cerebral perfusion and g-tolerance.","KEY POINTS


The aim of this study was to determine the effect of rotational axis position (RAP and thus g-gradient) during short-arm human centrifugation (SAHC) upon cardiovascular responses, cerebral perfusion and g-tolerance. In 10 male and 10 female participants, 10 min passive SAHC runs were performed with the RAP above the head (P1), at the apex of the head (P2), or at heart level (P3), with foot-level Gz at 1.0 g, 1.7 g and 2.4 g. We hypothesized that movement of the RAP from above the head (the conventional position) towards the heart might reduce central hypovolaemia, limit cardiovascular responses, aid cerebral perfusion, and thus promote g-tolerance. Moving the RAP footward towards the heart decreased the cerebral tissue saturation index, calf circumference and heart rate responses to SAHC, thereby promoting g-tolerance. Our results also suggest that RAP, and thus g-gradient, warrants further investigation as it may support use as a holistic spaceflight countermeasure.
ABSTRACT


Artificial gravity (AG) through short-arm human centrifugation (SAHC) has been proposed as a holistic spaceflight countermeasure. Movement of the rotational axis position (RAP) from above the head towards the heart may reduce central hypovolaemia, aid cerebral perfusion, and thus promote g-tolerance. This study determined the effect of RAP upon cardiovascular responses, peripheral blood displacement (i.e. central hypovolaemia), cerebral perfusion and g-tolerance, and their inter-relationships. Twenty (10 male) healthy participants (26.2 ± 4.0 years) underwent nine (following a familiarization run) randomized 10 min passive SAHC runs with RAP set above the head (P1), at the apex of the head (P2), or at heart level (P3) with foot-level Gz at 1.0 g, 1.7 g and 2.4 g. Cerebral tissue saturation index (cTSI, cerebral perfusion surrogate), calf circumference (CC, central hypovolaemia), heart rate (HR) and digital heart-level mean arterial blood pressure (MAP) were continuously recorded, in addition to incidence of pre-syncopal symptoms (PSS). ΔCC and ΔHR increases were attenuated from P1 to P3 (ΔCC: 5.46 ± 0.54 mm to 2.23 ± 0.42 mm; ΔHR: 50 ± 4 bpm to 8 ± 2 bpm, P < 0.05). In addition, ΔcTSI decrements were also attenuated (ΔcTSI: -2.85 ± 0.48% to -0.95 ± 0.34%, P < 0.05) and PSS incidence lower in P3 than P1 (P < 0.05). A positive linear relationship was observed between ΔCC and ΔHR with increasing +Gz, and a negative relationship between ΔCC and ΔcTSI, both independent of RAP. Our data suggest that movement of RAP towards the heart (reduced g-gradient), independent of foot-level Gz, leads to improved g-tolerance. Further investigations are required to assess the effect of differential baroreceptor feedback (i.e. aortic-carotid g-gradient).",2020,"Moving the RAP footward towards the heart decreased the cerebral tissue saturation index, calf circumference and heart rate responses to SAHC, thereby promoting g-tolerance.","['10 male and 10 female participants, 10-min passive SAHC runs were performed with the RAP above (P1), or at the apex of the head (P2), or at heart-level (P3), with foot-level Gz at 1.0\xa0g, 1.7\xa0g and 2.4\xa0g', 'Twenty (10 male) healthy participants (26.2\xa0±\xa04.0\xa0yr) underwent nine (following a familiarisation run) randomised']","['novel short-arm human centrifugation induced gravitational gradients', 'rotational axis position (RAP', 'short-arm human centrifugation (SAHC', 'RAP', '10-minute passive SAHC runs with RAP set above the head (P1), at the apex of the head (P2), or at heart-level (P3) with foot-level Gz at 1.0\xa0g, 1.7\xa0g and 2.4\xa0g', 'rotational axis position (RAP and thus g-gradient) during short-arm human centrifugation (SAHC']","['incidence of pre-syncopal symptoms (PSS', 'ΔcTSI decrements', 'cerebral tissue saturation index, calf circumference and heart rate responses to SAHC, thereby promoting g-tolerance', 'ΔCC and ΔHR increases', 'cardiovascular responses, peripheral blood displacement (i.e. central hypovolemia), cerebral perfusion and g-tolerance, and their inter-relationships', 'cardiovascular responses, cerebral perfusion and g-tolerance', 'PSS incidence', 'Cerebral tissue saturation index (cTSI, cerebral perfusion surrogate), calf circumference (CC, central hypovolemia), heart rate (HR) and digital heart-level mean arterial blood pressure (MAP']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C4517631', 'cui_str': '2.4'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C0426857', 'cui_str': 'Short arm'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0546884', 'cui_str': 'Hypovolemia'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",10.0,0.0415868,"Moving the RAP footward towards the heart decreased the cerebral tissue saturation index, calf circumference and heart rate responses to SAHC, thereby promoting g-tolerance.","[{'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Laing', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Green', 'Affiliation': ""King's College London, Centre for Human and Applied Physiological Sciences (CHAPS), London, UK.""}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Mulder', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Hinghofer-Szalkay', 'Affiliation': 'Gravitational Physiology and Medicine Research Unit, Division of Physiology, Medical University of Graz, Austria.'}, {'ForeName': 'Andrew P', 'Initials': 'AP', 'LastName': 'Blaber', 'Affiliation': 'Biomedical Physiology and Kinesiology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Joern', 'Initials': 'J', 'LastName': 'Rittweger', 'Affiliation': 'Institute of Aerospace Medicine, German Aerospace Center (DLR), Cologne, Germany.'}, {'ForeName': 'Nandu', 'Initials': 'N', 'LastName': 'Goswami', 'Affiliation': 'Gravitational Physiology and Medicine Research Unit, Division of Physiology, Medical University of Graz, Austria.'}]",The Journal of physiology,['10.1113/JP273615']
1712,32716603,The effect of adjuvant oral irrigation on self-administered oral care in the management of peri-implant mucositis: A randomized controlled clinical trial.,"OBJECTIVES


This single-blinded randomized clinical trial evaluated the effect of adjuvant oral irrigation in addition to self-administered oral care on prevalence and severity of peri-implant mucositis.
MATERIAL & METHODS


After randomization, patients suffering from peri-implant mucositis were assigned to the following: Group 1 (control) received oral hygiene instruction following a standardized protocol, including a sub- and supramucosal mechanical debridement. Group 2 and 3 additionally were instructed to use an oral irrigator with either water or 0.06% CHX solution. One implant per patient was considered for examination. Clinical examinations included Probing Depth, Bleeding on Probing (BOP-positive sites), and Modified Plaque and Gingival Index. A surrogate variable (mucositis severity score) was applied measuring severity of disease. Statistical analysis included linear regression models and sensitivity analysis.
RESULTS


Sixty periodontally healthy patients were examined for presence and severity of peri-implant mucositis. 70% of all patients reached complete resolution of disease after 12 weeks. The prevalence of peri-implant mucositis after 12 weeks was 50% in group 1, 35% in group 2, and 5% in group 3. Average BOP-positive sites were reduced in all groups after 12 weeks (mean change from baseline: group 1: -1.5; group 2: -1.8; group 3: -2.3).
CONCLUSION


Within the limits of the study, adjuvant use of an oral irrigator with 0.06% CHX in addition to mechanical biofilm removal and oral hygiene instruction can reduce the presence and severity of peri-implant mucositis after 12 weeks.",2020,"The prevalence of peri-implant mucositis after 12 weeks was 50% in group 1, 35% in group 2, and 5% in group 3.","['peri-implant mucositis', 'patients suffering from peri-implant mucositis', '60', 'periodontally healthy patients']","['oral hygiene instruction following a standardized protocol, including a sub- and supramucosal mechanical debridement', 'adjuvant oral irrigation', 'oral irrigator with either water or 0.06% CHX solution']","['prevalence of peri-implant mucositis', 'presence and severity of peri-implant mucositis', 'probing depth (PD), bleeding on probing (BOP-positive sites), modified plaque and gingiva-index (mPI, mGI', 'Average BOP-positive sites', 'complete resolution of disease']","[{'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0399271', 'cui_str': 'Oral irrigation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0335463', 'cui_str': 'Irrigator'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0663932', 'cui_str': 'SLPI protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",60.0,0.0604381,"The prevalence of peri-implant mucositis after 12 weeks was 50% in group 1, 35% in group 2, and 5% in group 3.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Bunk', 'Affiliation': 'Clinic of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Eisenburger', 'Initials': 'E', 'LastName': 'Michael', 'Affiliation': 'Clinic of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Häckl', 'Initials': 'H', 'LastName': 'Sebastian', 'Affiliation': 'Institute for Biostatistics, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Jörg', 'Affiliation': 'School of Dentistry and the Charles Perkins Centre, Faculty of Health and Medicine, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Stiesch', 'Initials': 'S', 'LastName': 'Meike', 'Affiliation': 'Clinic of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hanover, Germany.'}, {'ForeName': 'Grischke', 'Initials': 'G', 'LastName': 'Jasmin', 'Affiliation': 'Clinic of Prosthetic Dentistry and Biomedical Materials Science, Hannover Medical School, Hanover, Germany.'}]",Clinical oral implants research,['10.1111/clr.13638']
1713,32713006,Glycemic Response to a Renal-Specific Oral Nutritional Supplement in Patients With Diabetes Undergoing Hemodialysis: A Randomized Crossover Trial.,"BACKGROUND


Diabetes and malnutrition are common in patients with kidney failure. We aimed to evaluate the postprandial glucose response to oral nutritional supplement drinks (ONSs) in patients with diabetes undergoing hemodialysis treatment.
METHODS


A randomized, single-blind crossover study was conducted in patients with diabetes, and requiring chronic hemodialysis. Patients consumed either a renal-specific ONS, macronutrient-matched ONS, or standard ONS on 3 separate study days, during dialysis, following an overnight fast. Blood was collected before and 15, 30, 45, 60, 90, 120, and 180 minutes post ingestion. Mean net incremental area under the curve (iAUC) and peak incremental blood glucose concentration were compared across conditions, using analyses of variance.
RESULTS


Consumption of the renal-specific ONS resulted in the lowest mean net iAUC (87.9 ± 169.0 mmol/L per 3 hours) compared with macronutrient-matched (188.0 ± 127.5 mmol/L per 3 hours) and standard ONS (199.5 ± 169.2 mmol/L per 3 hours) (F 2,30  = 5.115, P = 0.012, partial n 2  = 0.254). Pairwise comparisons demonstrated a mean difference of 100.1 mmol/L per 3 hours (95% CI, -2.8 to 202.9) in mean iAUC between the renal-specific ONS and macronutrient-matched ONS (P = 0.058). Peak blood glucose concentration, corrected for baseline, was significantly lower after the renal-specific ONS (1.40 ± 1.0 mmol/L) compared with both macronutrient-matched (2.02 ± 0.71 mmol/L, P = 0.036) and standard ONS (2.3 ± 1.06 mmol/L, P = 0.017).
CONCLUSION


A renal-specific ONS elicits a lower postprandial glucose response than either macronutrient-matched ONS or standard ONS in patients with diabetes during hemodialysis.",2020,A renal-specific ONS elicits a lower postprandial glucose response than either macronutrient matched ONS or a standard ONS in patients with diabetes and ESKD undergoing haemodialysis.,"['patients with diabetes and ESKD undergoing haemodialysis', 'Patients with Diabetes Undergoing Haemodialysis', 'patients with diabetes and ESKD requiring chronic haemodialysis', 'patients with end-stage kidney disease (ESKD', 'patients with diabetes undergoing haemodialysis treatment']","['oral nutritional supplement drinks (ONS', 'Renal-Specific Oral Nutritional Supplement', 'renal-specific ONS, a macronutrient matched ONS or a standard ONS', 'macronutrient matched ONS or a standard ONS']","['mean net iAUC', 'Mean net incremental area under the curve (iAUC) and peak incremental blood glucose concentration (iBGC', 'Glycaemic Response', 'Peak blood glucose concentration', 'postprandial glucose response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",,0.0467334,A renal-specific ONS elicits a lower postprandial glucose response than either macronutrient matched ONS or a standard ONS in patients with diabetes and ESKD undergoing haemodialysis.,"[{'ForeName': 'Vishal Nainesh', 'Initials': 'VN', 'LastName': 'Patel', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Dijk', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Malarkey', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Brooke', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Whelan', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}, {'ForeName': 'Helen L', 'Initials': 'HL', 'LastName': 'MacLaughlin', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, UK.""}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1970']
1714,32717273,Effect of high-velocity and traditional resistance exercise on serum antioxidants and inflammation biomarkers in older women: A randomized crossover trial.,"INTRODUCTION


Contrary to the production of oxidant and inflammation biomarkers, antioxidant enzymes decrease with age and the adaptive response to oxidative stress is reduced. The effects of the different resistance exercise protocols to attenuate these conditions are largely unexplored.
OBJECTIVE


We compared the acute effects of traditional resistance exercise (TRE) and high velocity RE (HVRE) on inflammatory biomarkers and antioxidant activity in elderly women.
METHODS


Fourteen elderly women (67 ± 7 years) were randomly assigned to TRE or HVRE. Blood samples were collected to measure inflammatory markers and antioxidant enzymes at three time-points (pre-exercise, post-exercise, 30 min post-exercise).
RESULTS


TRE and HVRE induced acute reductions over time on tumor necrosis factor-alpha, interleukin-6 (IL-6), soluble receptor of IL-6 (sIL-6R), as well in catalase, glutathione and superoxide dismutase antioxidant levels without differences between groups. In addition, TRE and HVRE groups displayed acute increments in interleukin-10 (IL-10) and IL-10/IL-6 ratio over time, while the HVRE protocol displayed higher IL-10 values post-exercise and 30 min post-exercise time points as compared with TRE. Based on magnitude based inference, subjects from the HVRE group demonstrated superior responsiveness for IL-6 and IL-10 as compared with the TRE group. All participants from the HVRE group displayed a minimal clinical important difference on IL-10 levels as compared to only two persons from the TRE group.
CONCLUSION


Both RE protocols were capable of positive changes in inflammatory and antioxidant status in elderly subjects, but HVRE demonstrated a superior response on IL-10. The HVRE may be incorporated to exercise recommendation in this population.",2020,"TRE and HVRE induced acute reductions over time on tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), soluble receptor of IL-6 (sIL-6R), as well in catalase, glutathione (GSH) and superoxide dismutase (SOD) antioxidant levels without differences between groups.","['older women', 'elderly subjects', 'Fourteen elderly women (67\u202f±\u202f7\u202fyears', 'elderly women']","['traditional resistance exercise (TRE) and high velocity RE (HVRE', 'HVRE', 'TRE or HVRE', 'TRE and HVRE', 'High-velocity and traditional resistance exercise']","['superior responsiveness for IL-6 and IL-10', 'inflammatory biomarkers and antioxidant activity', 'Minimal Clinical Important Difference (MCID) on IL-10 levels', 'tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), soluble receptor of IL-6 (sIL-6R), as well in catalase, glutathione (GSH) and superoxide dismutase (SOD) antioxidant levels', 'interleukin-10 (IL-10) and IL-10/IL-6 ratio', 'serum antioxidants and inflammation biomarkers']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0257766', 'cui_str': 'SILV protein, human'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",14.0,0.134689,"TRE and HVRE induced acute reductions over time on tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), soluble receptor of IL-6 (sIL-6R), as well in catalase, glutathione (GSH) and superoxide dismutase (SOD) antioxidant levels without differences between groups.","[{'ForeName': 'Danilo Leandro Santos', 'Initials': 'DLS', 'LastName': 'de Castro', 'Affiliation': 'Department of Physical Education, Catholic University of Brasilia (UCB), Brasilia, Brazil.'}, {'ForeName': 'Dahan', 'Initials': 'D', 'LastName': 'da Cunha Nascimento', 'Affiliation': 'Department of Physical Education, Catholic University of Brasilia (UCB), Brasilia, Brazil; Department of Physical Education, Center University of Distrito Federal (UDF), Brasilia, Brazil; Department of Gerontology, Catholic University of Brasilia, UCB, Brasilia, DF, Brazil.'}, {'ForeName': 'Vânia Silva Macedo', 'Initials': 'VSM', 'LastName': 'Orsano', 'Affiliation': 'Department of Physical Education, Catholic University of Brasilia (UCB), Brasilia, Brazil.'}, {'ForeName': 'Ivo Vieira', 'Initials': 'IV', 'LastName': 'de Sousa Neto', 'Affiliation': 'Laboratory of Molecular Analysis, Graduate Program of Sciences and Technology of Health, University of Brasilia, Federal District, Brazil.'}, {'ForeName': 'Fabiani Lage Rodrigues', 'Initials': 'FLR', 'LastName': 'Beal', 'Affiliation': 'Department of Nutrition, Health and Medicine School, Catholic University of Brasilia, UCB, Brasilia, DF, Brazil; Department of Gerontology, Catholic University of Brasilia, UCB, Brasilia, DF, Brazil.'}, {'ForeName': 'Whitley', 'Initials': 'W', 'LastName': 'Stone', 'Affiliation': 'School of Kinesiology Recreation and Sport, Western Kentucky University, Bowling Green, USA.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Dos Santos Rosa', 'Affiliation': 'Department of Physical Education, Catholic University of Brasilia (UCB), Brasilia, Brazil.'}, {'ForeName': 'Jonato', 'Initials': 'J', 'LastName': 'Prestes', 'Affiliation': 'Department of Physical Education, Catholic University of Brasilia (UCB), Brasilia, Brazil. Electronic address: jonatop@gmail.com.'}]",Experimental gerontology,['10.1016/j.exger.2020.111026']
1715,32717696,Using unfolding case studies to develop critical thinking skills in baccalaureate nursing students: A pilot study.,"BACKGROUND


Research has consistently demonstrated that new graduate nurses do not possess sufficient critical thinking skills when they transition to clinical practice. Unfolding case studies encourage students to participate in a number of critical thinking skills including information-seeking, logical reasoning, and analyzing of clinical data.
OBJECTIVE


The aim of this study was to determine how the use of unfolding case studies as a learning modality affected baccalaureate students' critical thinking skills in their Adult Health Theory course. The researcher compared course examination scores earned by nursing students who were taught using traditional case studies to scores obtained by nursing students who completed unfolding case studies.
SETTING


The pilot study took place at a moderate-sized comprehensive university in Wisconsin.
DESIGN


A non-experimental correlational design using course examination scores data was employed to examine how the use of unfolding case studies as a learning modality affected baccalaureate students' critical thinking skills in their Adult Health Theory course.
PARTICIPANTS


A total of 160 students comprised the intervention group while an additional 142 students represented the control group in the study.
METHODS


An independent-samples t-test was performed to explore differences in mean scores between the intervention and control groups.
RESULTS


Results of the t-test indicate that mean examination scores were significantly higher for the intervention group (M = 234.9, SD = 13.1) than for the control group (M = 228.2, SD = 13.3); t(299) =, p < .001.
CONCLUSIONS


Results of this study suggest that unfolding case studies more effectively develop students' critical thinking skills than do a more traditional, static case study.",2020,"RESULTS


Results of the t-test indicate that mean examination scores were significantly higher for the intervention group (M = 234.9, SD = 13.1) than for the control group (M = 228.2, SD = 13.3); t(299) =, p < .001.
","['A total of 160 students comprised the intervention group while an additional 142 students represented the control group in the study', 'baccalaureate nursing students', 'The pilot study took place at a moderate-sized comprehensive university in Wisconsin']",[],"['mean scores', 'mean examination scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",160.0,0.0283034,"RESULTS


Results of the t-test indicate that mean examination scores were significantly higher for the intervention group (M = 234.9, SD = 13.1) than for the control group (M = 228.2, SD = 13.3); t(299) =, p < .001.
","[{'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Englund', 'Affiliation': 'University of Wisconsin Oshkosh, College of Nursing, 800 Algoma Blvd, Oshkosh, WI, United States of America. Electronic address: englundh@uwosh.edu.'}]",Nurse education today,['10.1016/j.nedt.2020.104542']
1716,32717713,"Effect of lifetime antiepileptic drug treatment history on efficacy and tolerability of adjunctive brivaracetam in adults with focal seizures: Post-hoc analysis of a randomized, placebo-controlled trial.","OBJECTIVE


To evaluate the efficacy and tolerability of adjunctive brivaracetam (BRV) in adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs).
METHODS


Post-hoc analysis of data from N01358 (NCT01261325), a randomized, double-blind, placebo (PBO)-controlled Phase III trial evaluating BRV 100 and 200 mg/day in patients ≥16 years of age with uncontrolled focal seizures. Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
RESULTS


764 patients received at least one dose of trial medication (BRV: 503; PBO: 261; Safety Set), of whom 14.3% had 1-2, 20.8% had 3-4, 21.3% had 5-6, and 43.6% had ≥7 lifetime AEDs. In all lifetime AED subgroups, >85% of patients completed the trial. Patients with a higher number of lifetime AEDs had a younger age at epilepsy onset, longer epilepsy duration, and higher baseline seizure frequency. In patients on BRV, 50% responder rates were 49.3%, 44.4%, 47.2% and 27.4% in patients with 1-2 (n = 75), 3-4 (n = 99), 5-6 (n = 108) and ≥7 (n = 219) lifetime AEDs; 75% responder rates were 36.0%, 21.2%, 22.2% and 12.3%. In patients on PBO, 50% responder rates were 35.3%, 25.9%, 20.4% and 15.9% in patients with 1-2 (n = 34), 3-4 (n = 58), 5-6 (n = 54) and ≥7 (n = 113) lifetime AEDs; 75% responder rates were 26.5%, 6.9%, 3.7% and 4.4%. The Kaplan-Meier estimated probability of patients achieving a sustained 50% or 75% response from the first day of treatment was generally higher in patients with a lower number of lifetime AEDs (both in patients on BRV and PBO). In patients on adjunctive BRV, the incidence of drug related treatment-emergent adverse events (TEAEs) was 34.7%, 26.0%, 44.4% and 47.7% in patients with 1-2 (n = 75), 3-4 (n = 100), 5-6 (n = 108) and ≥7 (n = 220) lifetime AEDs; the incidence of discontinuations due to TEAEs was 1.3%, 3.0%, 8.3% and 10.5%.
CONCLUSIONS


This post-hoc analysis suggests a numerically higher response to adjunctive BRV in patients with fewer lifetime AEDs. The lowest response was observed in patients with ≥7 lifetime AEDs, although these patients could also benefit from adjunctive BRV treatment. Patients with fewer lifetime AEDs had lower discontinuation of BRV due to TEAEs.",2020,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","['adults with focal seizures by the number of lifetime (previous and concomitant) antiepileptic drugs (AEDs', 'adults with focal seizures', 'subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs', 'patients ≥16 years of age with uncontrolled focal seizures']","['adjunctive brivaracetam (BRV', 'adjunctive brivaracetam', 'placebo']","['Efficacy and tolerability outcomes', 'responder rates', 'incidence of drug related treatment-emergent adverse events (TEAEs', 'efficacy and tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0442749', 'cui_str': '6/5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",764.0,0.103758,"Efficacy and tolerability outcomes were assessed for the 12-week Treatment Period in subgroups of patients with 1-2, 3-4, 5-6, or ≥7 lifetime AEDs.
","[{'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, 6410 Rockledge Drive, Suite 610, Bethesda, MD 20817, USA. Electronic address: kleinp@epilepsydc.com.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McLachlan', 'Affiliation': 'Western University, 339 Windermere Road, London, ON N6A 5A5, Canada. Electronic address: rsmcl@uwo.ca.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Foris', 'Affiliation': 'UCB Pharma, 2060 Winston Park Drive, Suite 401, Oakville, ON L6H 5R7, Canada. Electronic address: kforis@sympatico.ca.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Nondonfaz', 'Affiliation': ""UCB Pharma, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium. Electronic address: xavier.nondonfaz@ucb.com.""}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Dimova', 'Affiliation': 'UCB Pharma, Allée de la Recherche 60, 1070 Brussels, Belgium. Electronic address: svetlana.dimova@ucb.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Center, Mara Hospital, Maraweg 21, 33617 Bielefeld, Germany. Electronic address: christian.brandt@mara.de.'}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106369']
1717,32718237,"Intensity of statin treatment after acute coronary syndrome, residual risk, and its modification by alirocumab: insights from the ODYSSEY OUTCOMES trial.","AIMS


Statins are pivotal to the secondary prevention of major adverse cardiovascular events, but some patients are statin-intolerant. We examined the effects of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab on the risk of major adverse cardiovascular events according to the intensity of background statin treatment.
METHODS AND RESULTS


The ODYSSEY OUTCOMES trial compared alirocumab with placebo in 18,924 patients with acute coronary syndrome and dyslipidaemia despite intensive or maximum-tolerated statin treatment (including no statin if intolerance was documented). The primary outcome (major adverse cardiovascular events) comprised coronary heart disease death, non-fatal myocardial infarction, ischaemic stroke, or unstable angina. Median follow-up was 2.8 years. Baseline statin treatment was high-intensity (88.8%), low/moderate-intensity (8.7%) or none (2.4%). Median baseline low-density lipoprotein cholesterol was 86, 89 and 139 mg/dL ( P  < 0.001) in these statin treatment categories, respectively. Alirocumab produced similar relative reductions in low-density lipoprotein cholesterol from baseline across statin treatment subgroups, but the mean absolute reductions differed (52.9, 56.7 and 86.1 mg/dL, respectively;  P  < 0.001). With placebo, the incidence of major adverse cardiovascular events was highest in the no statin subgroup (10.8%, 10.7% and 26.0% respectively). Alirocumab reduced major adverse cardiovascular events in each statin subgroup (hazard ratio 0.88, 95% confidence interval (CI) 0.80-0.96; 0.68, 0.49-0.94; and 0.65, 0.44-0.97, respectively;  P interaction  = 0.14) with a gradient of absolute risk reduction: 1.25%, 95% CI 0.34-2.16; 3.16%, 0.38-5.94; 7.97%, 0.42-15.51;  P interaction  = 0.106).
CONCLUSIONS


PCSK9 inhibition with alirocumab reduces the relative risk of major adverse cardiovascular events after acute coronary syndrome irrespective of background statin treatment. However, patients on no statin are at high absolute risk for recurrent major adverse cardiovascular events; alirocumab substantially reduces that risk. PCSK9 inhibition may be an important therapeutic strategy for statin-intolerant patients with acute coronary syndrome.",2020,"Alirocumab reduced major adverse cardiovascular events in each statin subgroup (hazard ratio 0.88, 95% confidence interval (CI) 0.80-0.96; 0.68, 0.49-0.94; and 0.65, 0.44-0.97, respectively;  P interaction  = 0.14) with a gradient of absolute risk reduction: 1.25%, 95% CI 0.34-2.16; 3.16%, 0.38-5.94; 7.97%, 0.42-15.51;  P interaction  = 0.106).
","['statin-intolerant patients with acute coronary syndrome', '18,924 patients with acute coronary syndrome and dyslipidaemia despite intensive or maximum-tolerated statin treatment (including no statin if intolerance was documented']","['alirocumab', 'Alirocumab', 'proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab', 'alirocumab with placebo', 'placebo']","['low-density lipoprotein cholesterol', 'relative risk of major adverse cardiovascular events', 'primary outcome (major adverse cardiovascular events) comprised coronary heart disease death, non-fatal myocardial infarction, ischaemic stroke, or unstable angina', 'incidence of major adverse cardiovascular events', 'Median baseline low-density lipoprotein cholesterol', 'major adverse cardiovascular events']","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C1174937', 'cui_str': 'PCSK9 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",18924.0,0.262183,"Alirocumab reduced major adverse cardiovascular events in each statin subgroup (hazard ratio 0.88, 95% confidence interval (CI) 0.80-0.96; 0.68, 0.49-0.94; and 0.65, 0.44-0.97, respectively;  P interaction  = 0.14) with a gradient of absolute risk reduction: 1.25%, 95% CI 0.34-2.16; 3.16%, 0.38-5.94; 7.97%, 0.42-15.51;  P interaction  = 0.106).
","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latino América, Instituto Cardiovascular de Rosario, Argentina.'}, {'ForeName': 'Qian H', 'Initials': 'QH', 'LastName': 'Li', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, USA.""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, USA.'}, {'ForeName': 'Marie T', 'Initials': 'MT', 'LastName': 'Baccara-Dinet', 'Affiliation': 'Sanofi R&D, Montpellier, France.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Canada.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, The Netherlands.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Kyoto University, Graduate School of Medicine, Japan.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Parkhomenko', 'Affiliation': 'MD Strazhesko Institute of Cardiology, AMS of Ukraine, Ukraine.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals Inc., Tarrytown, USA.'}, {'ForeName': 'Željko', 'Initials': 'Ž', 'LastName': 'Reiner', 'Affiliation': 'University Hospital Center Zagreb, University of Zagreb, Croatia.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, USA.'}, {'ForeName': 'Hung-Fat', 'Initials': 'HF', 'LastName': 'Tse', 'Affiliation': ""Queen Mary Hospital, Hong Kong, Special Administrative Region of the People's Republic of China.""}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services, Auckland City Hospital, New Zealand.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Zahger', 'Affiliation': 'Soroka University Medical Center, Ben Gurion University of the Negev, Israel.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Germany.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, USA.'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, FACT (French Alliance for Cardiovascular Trials), and INSERM, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of preventive cardiology,['10.1177/2047487320941987']
1718,32718816,"First-in-human administration of a live-attenuated RSV vaccine lacking the G-protein assessing safety, tolerability, shedding and immunogenicity: a randomized controlled trial.","BACKGROUND


Human respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infections in early infancy and in elderly. A pediatric vaccine against RSV would not only prevent morbidity and mortality amongst infants and young children but could also reduce transmission to elderly. The RSVΔG vaccine consists of a live-attenuated RSV that lacks the G attachment protein. RSVΔG is severely impaired in binding to host cells and exhibits reduced infectivity in preclinical studies. Intranasal immunization of cotton rats with RSVΔG vaccine protected against replication of wildtype RSV, without inducing enhanced disease.
METHODS


We performed a first-in-human trial with primary objective to evaluate safety and shedding of RSVΔG (6.5 log 10  CCID 50 ) after intranasal administration. Healthy adults aged between 18 and 50, with RSV neutralizing serum titers below 9.6 log 2 , received a single dose of either vaccine or placebo (n = 48, ratio 3:1). In addition to safety and tolerability, nasal viral load, and systemic and humoral immune responses were assessed at selected time points until 4 weeks after immunization.
RESULTS


Intranasal administration of RSVΔG was well tolerated with no findings of clinical concern. No infectious virus was detected in nasal wash samples. Similar to other live-attenuated RSV vaccines, neutralizing antibody response following inoculation was limited in seropositive adults.
CONCLUSIONS


A single dose of 6.5 log 10  CCID 50  of RSVΔG was safe and well-tolerated in seropositive healthy adults. RSVΔG was sufficiently attenuated but there were no signs of induction of antibodies. Safety and immunogenicity can now be explored in children and eventually in seronegative infants. Clinical trial register: NTR7173/EudraCT number 2016-002437-30.",2020,"In addition to safety and tolerability, nasal viral load, and systemic and humoral immune responses were assessed at selected time points until 4 weeks after immunization.
","['seropositive healthy adults', 'early infancy and in elderly', 'infants and young children', 'children and eventually in seronegative infants', 'number 2016-002437-30', 'Healthy adults aged between 18 and 50, with RSV neutralizing serum titers below 9.6 log 2 , received a single dose of either', 'cotton rats with']","['RSVΔG', 'RSVΔG vaccine', 'vaccine or placebo', 'NTR7173/EudraCT']","['morbidity and mortality', 'safety, tolerability, shedding and immunogenicity', 'Safety and immunogenicity', 'safety and tolerability, nasal viral load, and systemic and humoral immune responses']","[{'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0034695', 'cui_str': 'Rats, Cotton'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}]",,0.293366,"In addition to safety and tolerability, nasal viral load, and systemic and humoral immune responses were assessed at selected time points until 4 weeks after immunization.
","[{'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Verdijk', 'Affiliation': 'Institute for Translational Vaccinology (Intravacc), Bilthoven, The Netherlands.'}, {'ForeName': 'Johan L', 'Initials': 'JL', 'LastName': 'van der Plas', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands; Department of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Emilie M J', 'Initials': 'EMJ', 'LastName': 'van Brummelen', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands.'}, {'ForeName': 'Rienk E', 'Initials': 'RE', 'LastName': 'Jeeninga', 'Affiliation': 'Viroclinics Biosciences B.V., Rotterdam, The Netherlands.'}, {'ForeName': 'Cornelis A M', 'Initials': 'CAM', 'LastName': 'de Haan', 'Affiliation': 'Virology Division, Department Biomolecular Health Sciences, Faculty of Veterinary Medicine, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Meta', 'Initials': 'M', 'LastName': 'Roestenberg', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands; Department of Parasitology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Jacobus', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands; Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Ingrid M C', 'Initials': 'IMC', 'LastName': 'Kamerling', 'Affiliation': 'Centre for Human Drug Research, Leiden, The Netherlands; Department of Infectious Diseases, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: IdVisser@chdr.nl.'}]",Vaccine,['10.1016/j.vaccine.2020.07.029']
1719,32719307,Effect of Concentration/Dose Ratio in De Novo Kidney Transplant Recipients Receiving LCP-Tacrolimus or Immediate-Release Tacrolimus: Post Hoc Analysis of a Phase 3 Clinical Trial.,"BACKGROUND A previous phase 3 clinical trial in de novo adult kidney transplant recipients (NCT01187953) compared the efficacy and safety of once-daily LCP-tacrolimus (LCPT) and twice-daily immediate-release tacrolimus (IR-Tac). However, whether the rate of tacrolimus metabolism affects outcomes between LCPT and IR-Tac was not examined. MATERIAL AND METHODS Patients were initiated on 0.17 mg/kg/day LCPT or 0.1 mg/kg/day IR-Tac, with doses adjusted over time to maintain target therapeutic trough concentrations. This post hoc analysis examined dosing trends, relative efficacy, and safety of LCPT (n=247) and IR-Tac (n=249) in slow, intermediate, and rapid metabolizers as defined by concentration/dose ratios at day 30. RESULTS For all metabolizer subgroups, minimum target tacrolimus trough concentrations were obtained more rapidly with LCPT than with IR-Tac. Slow metabolizers were more likely to exceed target trough concentrations with LCPT, while rapid metabolizers were more likely to fall below target trough concentrations with IR-Tac. Regardless of metabolizer status, significant differences were not detected between LCPT and IR-Tac for treatment failure, death, graft failure, biopsy-proven acute rejection, estimated glomerular filtration rate, or other clinical outcomes. CONCLUSIONS Although within metabolizer subgroups, attainment of target trough concentrations in the first week differed between LCPT and IR-Tac, these results suggest that, regardless of metabolizer phenotype, clinical outcomes do not differ between these formulations when dose adjustments are made.",2020,"Regardless of metabolizer status, significant differences were not detected between LCPT and IR-Tac for treatment failure, death, graft failure, biopsy-proven acute rejection, estimated glomerular filtration rate, or other clinical outcomes.","['De Novo Kidney Transplant Recipients Receiving LCP-Tacrolimus or Immediate-Release', 'Patients were initiated on 0.17 mg/kg/day']","['LCPT', 'Tacrolimus', 'LCP-tacrolimus (LCPT) and twice-daily immediate-release tacrolimus (IR-Tac']","['attainment of target trough concentrations', 'LCPT and IR-Tac for treatment failure, death, graft failure, biopsy-proven acute rejection, estimated glomerular filtration rate', 'minimum target tacrolimus trough concentrations']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517432', 'cui_str': '0.17'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023234', 'cui_str': 'Coxa plana'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035015', 'cui_str': 'Rejection (Psychology)'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",,0.0370611,"Regardless of metabolizer status, significant differences were not detected between LCPT and IR-Tac for treatment failure, death, graft failure, biopsy-proven acute rejection, estimated glomerular filtration rate, or other clinical outcomes.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Suwelack', 'Affiliation': 'Department of Internal Medicine, Transplant Nephrology, University Hospital Münster, Westfalian Wilhelms University, Münster, Germany.'}, {'ForeName': 'Suphamai', 'Initials': 'S', 'LastName': 'Bunnapradist', 'Affiliation': 'Division of Nephrology, University of California Los Angeles (UCLA) Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Meier-Kriesche', 'Affiliation': 'Veloxis Pharmaceuticals Inc., Cary, NC, USA.'}, {'ForeName': 'Daniel R', 'Initials': 'DR', 'LastName': 'Stevens', 'Affiliation': 'Veloxis Pharmaceuticals Inc., Cary, NC, USA.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Procaccianti', 'Affiliation': 'Chiesi Farmaceutici S.p.A., Parma, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Morganti', 'Affiliation': 'Chiesi Farmaceutici S.p.A., Parma, Italy.'}, {'ForeName': 'Klemens', 'Initials': 'K', 'LastName': 'Budde', 'Affiliation': 'Department of Nephrology and Medical Intensive Care, Charité - University Medicine Berlin, Berlin, Germany.'}]",Annals of transplantation,['10.12659/AOT.923278']
1720,32720628,Cost-effectiveness of WHO Problem Management Plus for adults with mood and anxiety disorders in a post-conflict area of Pakistan: randomised controlled trial.,"BACKGROUND


With the development of evidence-based interventions for treatment of priority mental health conditions in humanitarian settings, it is important to establish the cost-effectiveness of such interventions to enable their scale-up.
AIMS


To evaluate the cost-effectiveness of the Problem Management Plus (PM+) intervention compared with enhanced usual care (EUC) for common mental disorders in primary healthcare in Peshawar, Pakistan. Trial registration ACTRN12614001235695 (anzctr.org.au).
METHOD


We randomly allocated 346 participants to either PM+ (n = 172) or EUC (n = 174). Effectiveness was measured using the Hospital Anxiety and Depression Scale (HADS) at 3 months post-intervention. Cost-effectiveness analysis was performed as incremental costs (measured in Pakistani rupees, PKR) per unit change in anxiety, depression and functioning scores.
RESULTS


The total cost of delivering PM+ per participant was estimated at PKR 16 967 (US$163.14) using an international trainer and supervisor, and PKR 3645 (US$35.04) employing a local trainer. The mean cost per unit score improvement in anxiety and depression symptoms on the HADS was PKR 2957 (95% CI 2262-4029) (US$28) with an international trainer/supervisor and PKR 588 (95% CI 434-820) (US$6) with a local trainer/supervisor. The mean incremental cost-effectiveness ratio (ICER) to successfully treat a case of depression (PHQ-9 ≥ 10) using an international supervisor was PKR 53 770 (95% CI 39 394-77 399) (US$517), compared with PKR 10 705 (95% CI 7731-15 627) (US$102.93) using a local supervisor.
CONCLUSIONS


The PM+ intervention was more effective but also more costly than EUC in reducing symptoms of anxiety, depression and improving functioning in adults impaired by psychological distress in a post-conflict setting of Pakistan.",2020,"The PM+ intervention was more effective but also more costly than EUC in reducing symptoms of anxiety, depression and improving functioning in adults impaired by psychological distress in a post-conflict setting of Pakistan.","['53', 'common mental disorders in primary healthcare in Peshawar, Pakistan', 'adults with mood and anxiety disorders in a post-conflict area of Pakistan', '346 participants to either']","['WHO Problem Management', 'PM+ intervention', 'enhanced usual care (EUC', 'Problem Management Plus (PM+) intervention', 'PM', 'EUC', 'international supervisor was PKR']","['mean cost per unit score improvement in anxiety and depression symptoms', 'mean incremental cost-effectiveness ratio (ICER', 'incremental costs (measured in Pakistani rupees, PKR) per unit change in anxiety, depression and functioning scores', 'symptoms of anxiety, depression and improving functioning', 'Hospital Anxiety and Depression Scale (HADS', 'cost-effectiveness', 'total cost of delivering PM']","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0403172', 'cui_str': 'Supervisor'}, {'cui': 'C0058980', 'cui_str': 'Hemin-Controlled Translational Repressor'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0240620', 'cui_str': 'Pakistani'}, {'cui': 'C0058980', 'cui_str': 'Hemin-Controlled Translational Repressor'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",346.0,0.173334,"The PM+ intervention was more effective but also more costly than EUC in reducing symptoms of anxiety, depression and improving functioning in adults impaired by psychological distress in a post-conflict setting of Pakistan.","[{'ForeName': 'Syed Usman', 'Initials': 'SU', 'LastName': 'Hamdani', 'Affiliation': 'Institute of Life and Human Sciences, University of Liverpool, UK; and Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Zill-E-', 'Initials': 'ZE', 'LastName': 'Huma', 'Affiliation': 'Human Development Research Foundation, Islamabad, Pakistan.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Institute of Life and Human Sciences, University of Liverpool, UK.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Liverpool School of Tropical Medicine, UK.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Liverpool School of Tropical Medicine, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van Ommeren', 'Affiliation': 'Department of Mental Health and Substance Abuse, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chisholm', 'Affiliation': 'WHO Regional Office for Europe, Copenhagen, Denmark.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Farooq', 'Affiliation': 'Lady Reading Hospital, Peshawar, Pakistan; and School of Primary, Community and Social Care, Keele University, UK.'}]",The British journal of psychiatry : the journal of mental science,['10.1192/bjp.2020.138']
1721,32720906,"Maternal Parenting Electronic Diary in the Context of a Home Visit Intervention for Adolescent Mothers in an Urban Deprived Area of São Paulo, Brazil: Randomized Controlled Trial.","BACKGROUND


Pregnancy during adolescence is prevalent in low- and middle-income countries (LMICs), which is associated with various adverse outcomes that can be prevented with home visiting programs. However, testing these interventions in LMICs can be challenging due to limited resources. The use of electronic data collection via smartphones can be an alternative and ideal low-cost method to measure outcomes in an environment with adverse conditions.
OBJECTIVE


Our study had two objectives: to test the efficacy of a nurse home visiting intervention on maternal parenting and well-being measured by an electronic daily diary (eDiary), and to investigate the compliance rate of the eDiary measurement method.
METHODS


We conducted a randomized controlled trial to test the efficacy of Primeiros Laços, a nurse home visiting program, for adolescent mothers living in an urban deprived area of São Paulo, Brazil. A total of 169 pregnant adolescents were assessed for eligibility criteria, 80 of whom were included and randomized to the intervention (n=40) and control group (care as usual, n=40). Primeiros Laços is a home visiting intervention delivered by trained nurses tailored to first-time pregnant adolescents and their children, starting during the first 16 weeks of pregnancy until the child reaches 24 months of age. Participants were assessed by blind interviewers at 8-16 weeks of pregnancy (baseline), 30 weeks of pregnancy, and when the child was 3, 6, and 12 months of age. At 18 months, participants were assessed regarding maternal parenting and parental well-being using a 7-consecutive-day eDiary. The smartphone app was programmed to notify participants every day at 9:00 PM over a period of seven days.
RESULTS


We were able to contact 57/80 (71%) participants (29 from the intervention group and 28 from the control group) when the child was 18 months of age. Forty-eight of the 57 participants (84%) completed at least one day of the eDiary protocol. The daily compliance rate ranged from 49% to 70%. Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, 95% CI [0.06, 0.58], P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds ratio=2.33, 95% CI [1.20, 4.50], P=.01).Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds ratio=2.33, P=.01).
CONCLUSIONS


The Primeiros Laços intervention improved maternal parenting and parental well-being, demonstrating its promise for low-income adolescent mothers. The compliance rate of the eDiary assessment showed that it was generally accepted by adolescent mothers with limited resources. Future studies can implement ambulatory assessment in LMICs via smartphones to measure mother and child behaviors.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02807818; https://clinicaltrials.gov/ct2/show/NCT02807818.",2020,"Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, 95% CI [0.06, 0.58], P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds ratio=2.33, 95% CI [1.20, 4.50], P=.01).Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds","['adolescent mothers living in an urban deprived area of São Paulo, Brazil', '169 pregnant adolescents were assessed for eligibility criteria, 80 of whom were included and randomized to the intervention (n=40) and control group (care as usual, n=40', 'Forty-eight of the 57 participants (84%) completed at least one day of the eDiary protocol', 'adolescent mothers with limited resources', 'Adolescent Mothers in an Urban Deprived Area of São Paulo, Brazil']","['Primeiros Laços, a nurse home visiting program', 'nurse home visiting intervention']","['compliance rate of the eDiary assessment', 'maternal parenting behavior of the mother telling a story or singing to the child (odds', 'maternal parenting behavior of the mother telling a story or singing to the child', 'Maternal Parenting Electronic Diary', 'maternal parenting and parental well-being', 'daily compliance rate']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",169.0,0.0833277,"Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, 95% CI [0.06, 0.58], P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds ratio=2.33, 95% CI [1.20, 4.50], P=.01).Our analyses showed a significant effect of the intervention on parental well-being (B=0.32, P=.02) and the maternal parenting behavior of the mother telling a story or singing to the child (odds","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fatori', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Argeu', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Brentani', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Chiesa', 'Affiliation': 'Collective Health Nursing Department, School of Nursing, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Lislaine', 'Initials': 'L', 'LastName': 'Fracolli', 'Affiliation': 'Collective Health Nursing Department, School of Nursing, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Matijasevich', 'Affiliation': 'Department of Preventive Medicine, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Euripedes C', 'Initials': 'EC', 'LastName': 'Miguel', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Polanczyk', 'Affiliation': 'Department of Psychiatry, University of Sao Paulo Medical School, Sao Paulo, Brazil.'}]",JMIR mHealth and uHealth,['10.2196/13686']
1722,32720907,Impact of an Electronic Health Service on Child Participation in Pediatric Oncology Care: Quasiexperimental Study.,"BACKGROUND


For children 6-12 years old, there is a shortage of electronic Health (eHealth) services that promote their participation in health care. Therefore, a digital communication tool, called Sisom, was developed to give children a voice in their health care. Children with long-term diseases want to be more involved in their health care and have the right to receive information, be listened to, express their opinions, and participate in decision making in health care. However, the outcomes of using Sisom in practice at pediatric oncology clinics have not been investigated.
OBJECTIVE


The aim of this study was to investigate children's participation during appointments with pediatricians at pediatric oncology clinics, with or without the use of the eHealth service Sisom.
METHODS


A quasiexperimental design with mixed methods was used. We analyzed 27 filmed appointments with pediatricians for 14 children (8 girls and 6 boys) aged 6-12 years (mean 8.3 years) with a cancer diagnosis. The intervention group consisted of children who used Sisom prior to their appointments with pediatricians at a pediatric oncology clinic, and the control group consisted of children who had appointments with pediatricians at 4 pediatric oncology clinics. Data from observations from the videos were quantitatively and qualitatively analyzed. The quantitative analysis included manual calculations of how many times the pediatricians spoke directly to the children, the proportion of the appointment time that the children were talking, and levels of participation by the children. For the qualitative analysis, we used directed content analysis to analyze the children's levels of participation guided by a framework based on Shier's model of participation.
RESULTS


Pediatricians directed a greater proportion of their discussion toward the child in the intervention group (731 occasions) than in the control group (624 occasions), but the proportion of the appointment time the children talked was almost the same for both the intervention and control groups (mean 17.0 minutes vs 17.6 minutes). The levels of participation corresponded to the first three levels of Shier's participation model: children were listened to, children were supported to express their views, and children's views were taken into account. The results showed an increased level of participation by the children in the intervention group. Several codes that were found did not fit into any of the existing categories, and a new category was thus formed: children received information.
CONCLUSIONS


This study shows that the eHealth service Sisom can increase children's participation during appointments with health care professionals. Further studies employing a randomized control design focusing on the effects of eHealth services on children's health outcomes, perceived participation, and cost-effectiveness could make a significant contribution to guiding the implementation of eHealth services in pediatric care.",2020,This study shows that the eHealth service Sisom can increase children's participation during appointments with health care professionals.,"['Children with long-term diseases', ""children's participation during appointments with pediatricians at pediatric oncology clinics, with or without the use of the eHealth service Sisom"", 'Child Participation in Pediatric Oncology Care', 'children 6-12 years old', '27 filmed appointments with pediatricians for 14 children (8 girls and 6 boys) aged 6-12 years (mean 8.3 years) with a cancer diagnosis']","['children who used Sisom prior to their appointments with pediatricians at a pediatric oncology clinic, and the control group consisted of children who had appointments with pediatricians at 4 pediatric oncology clinics', 'Electronic Health Service']","['level of participation', 'proportion of the appointment time the children talked']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0237433', 'cui_str': 'Pediatrician'}, {'cui': 'C3816504', 'cui_str': 'Pediatric oncology clinic'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C1518931', 'cui_str': 'Pediatric oncology'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3816504', 'cui_str': 'Pediatric oncology clinic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]",,0.0229075,This study shows that the eHealth service Sisom can increase children's participation during appointments with health care professionals.,"[{'ForeName': 'Britt-Mari', 'Initials': 'BM', 'LastName': 'Gilljam', 'Affiliation': 'School of Health and Welfare, Halmstad University, Halmstad, Sweden.'}, {'ForeName': 'Jens M', 'Initials': 'JM', 'LastName': 'Nygren', 'Affiliation': 'School of Health and Welfare, Halmstad University, Halmstad, Sweden.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Svedberg', 'Affiliation': 'School of Health and Welfare, Halmstad University, Halmstad, Sweden.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Arvidsson', 'Affiliation': 'School of Health and Welfare, Halmstad University, Halmstad, Sweden.'}]",Journal of medical Internet research,['10.2196/17673']
1723,32720908,Changing the Health Behavior of Patients With Cardiovascular Disease Through an Electronic Health Intervention in Three Different Countries: Cost-Effectiveness Study in the Do Cardiac Health: Advanced New Generation Ecosystem (Do CHANGE) 2 Randomized Controlled Trial.,"BACKGROUND


During the last few decades, preventing the development of cardiovascular disease has become a mainstay for reducing cardiovascular morbidity and mortality. It has been suggested that interventions should focus more on committed approaches of self-care, such as electronic health techniques.
OBJECTIVE


This study aimed to provide evidence to understand the financial consequences of implementing the ""Do Cardiac Health: Advanced New Generation Ecosystem"" (Do CHANGE 2) intervention, which was evaluated in a multisite randomized controlled trial to change the health behavior of patients with cardiovascular disease.
METHODS


The cost-effectiveness analysis of the Do CHANGE 2 intervention was performed with the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing tool, based on a Markov model of five health states. The following two types of costs were considered for both study groups: (1) health care costs (ie, costs associated with the time spent by health care professionals on service provision, including consultations, and associated unplanned hospitalizations, etc) and (2) societal costs (ie, costs attributed to the time spent by patients and informal caregivers on care activities).
RESULTS


The Do CHANGE 2 intervention was less costly in Spain (incremental cost was -€2514.90) and more costly in the Netherlands and Taiwan (incremental costs were €1373.59 and €1062.54, respectively). Compared with treatment as usual, the effectiveness of the Do CHANGE 2 program in terms of an increase in quality-adjusted life-year gains was slightly higher in the Netherlands and lower in Spain and Taiwan.
CONCLUSIONS


In general, we found that the incremental cost-effectiveness ratio strongly varied depending on the country where the intervention was applied. The Do CHANGE 2 intervention showed a positive cost-effectiveness ratio only when implemented in Spain, indicating that it saved financial costs in relation to the effect of the intervention.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03178305; https://clinicaltrials.gov/ct2/show/NCT03178305.",2020,"The Do CHANGE 2 intervention was less costly in Spain (incremental cost was -€2514.90) and more costly in the Netherlands and Taiwan (incremental costs were €1373.59 and €1062.54, respectively).",['patients with cardiovascular disease'],['Electronic Health Intervention'],"['cardiovascular morbidity and mortality', 'incremental cost-effectiveness ratio', 'health care costs (ie, costs associated with the time spent by health care professionals on service provision, including consultations, and associated unplanned hospitalizations, etc) and (2) societal costs (ie, costs attributed to the time spent by patients and informal caregivers on care activities', 'quality-adjusted life-year gains', 'positive cost-effectiveness ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0449234', 'cui_str': 'Attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.0814669,"The Do CHANGE 2 intervention was less costly in Spain (incremental cost was -€2514.90) and more costly in the Netherlands and Taiwan (incremental costs were €1373.59 and €1062.54, respectively).","[{'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Piera-Jiménez', 'Affiliation': 'Open Evidence Research Group, Universitat Oberta de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Winters', 'Affiliation': 'Smart Homes, Eindhoven, Netherlands.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Broers', 'Affiliation': 'Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Damià', 'Initials': 'D', 'LastName': 'Valero-Bover', 'Affiliation': 'Department of R&D, Badalona Serveis Assistencials, Badalona, Spain.'}, {'ForeName': 'Mirela', 'Initials': 'M', 'LastName': 'Habibovic', 'Affiliation': 'Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Jos W M G', 'Initials': 'JWMG', 'LastName': 'Widdershoven', 'Affiliation': 'Department of Medical and Clinical Psychology, Tilburg University, Tilburg, Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Folkvord', 'Affiliation': 'Open Evidence Research Group, Universitat Oberta de Catalunya, Barcelona, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Lupiáñez-Villanueva', 'Affiliation': 'Open Evidence Research Group, Universitat Oberta de Catalunya, Barcelona, Spain.'}]",Journal of medical Internet research,['10.2196/17351']
1724,32723109,User experiences with second-generation 32-gauge × 4 mm vs. thinner comparator pen needles: prospective randomized trial.,"OBJECTIVE


Two similarly designed studies compared user experiences with a second-generation extra-thin-wall, 5-bevel 32 G × 4 mm pen needle (PN) with redesigned hub versus four thinner commercially available PNs.
METHODS


Adults (18-75 years old) with type 1 or type 2 diabetes and ≥3 months of experience with pen injectors qualified for single-visit, single-blinded randomized studies. The investigational 32 G PN was compared with three 33-34 G × 3.5-4 mm PNs in Study 1 and one 34 G × 4 mm PN in Study 2. Participants completed 12 abdominal injections of 0.3 mL sterile saline using insulin pens in 6 pairs, each comprising one investigational 32 G PN and one comparator PN in random order. After each injection pair, participants compared injection pain via relative 150 mm visual analog scale (VAS) and perceived dose delivery force via relative 5 point Likert scale. Adjusted models tested injection pain scores (primary endpoint) for noninferiority and, if met, then for superiority. ClinicalTrials.gov identifiers: NCT03878758 and NCT03878745.
RESULTS


The investigational 32 G PN met noninferiority as well as superiority criteria for less injection pain vs. each comparator ( p  < .01), with adjusted mean relative VAS scores 9.1-17.6 in Study 1 ( n  = 154) and 7.3 in Study 2 ( n  = 55). The investigational 32 G PN was also superior vs. each comparator PN in requiring less relative perceived force to deliver the dose ( p  < .01).
CONCLUSIONS


The investigational 32 G PN was associated with less participant-reported injection pain and less perceived dose delivery force compared with four thinner PNs, suggesting no additional pain reduction or force reduction benefit conferred by the thinner PNs.",2020,"The investigational 32G PN was associated with less participant-reported injection pain and less perceived dose delivery force compared with four thinner PNs, suggesting no additional pain reduction or force reduction benefit conferred by the thinner PNs.","['Methods:  Adults (18-75 years old) with type 1 or type 2 diabetes and ≥3 months of experience with pen injectors qualified for single-visit, single-blinded randomized studies']","['second-generation extra-thin-wall, 5-bevel 32Gx4mm pen needle (PN) with redesigned hub versus four thinner commercially available PNs']","['injection pain via relative 150-mm visual analog scale (VAS) and perceived dose delivery force via relative 5-point Likert scale', 'injection pain', 'injection pain scores', 'VAS scores']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4025916', 'cui_str': 'Pen Injector'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0070220', 'cui_str': 'penclomedine'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0206417', 'cui_str': 'Peripheral nervous system structure'}]","[{'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2.0,0.394199,"The investigational 32G PN was associated with less participant-reported injection pain and less perceived dose delivery force compared with four thinner PNs, suggesting no additional pain reduction or force reduction benefit conferred by the thinner PNs.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Gibney', 'Affiliation': 'Diabetes Care, Becton, Dickinson and Company (BD), Franklin Lakes, NJ, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitz-Patrick', 'Affiliation': 'Department of Diabetes and Endocrinology, East-West Medical Research Institute, Honolulu, HI, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Klonoff', 'Affiliation': 'Diabetes Research Institute, Mills-Peninsula Medical Center, San Mateo, CA, USA.'}, {'ForeName': 'Shahista', 'Initials': 'S', 'LastName': 'Whooley', 'Affiliation': 'Diabetes Care, Becton, Dickinson and Company (BD), Franklin Lakes, NJ, USA.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Diabetes Care, Becton, Dickinson and Company (BD), Franklin Lakes, NJ, USA.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Yue', 'Affiliation': 'Global Clinical Development, BD, Franklin Lakes, NJ, USA.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Glezer', 'Affiliation': 'Diabetes Care, Becton, Dickinson and Company (BD), Franklin Lakes, NJ, USA.'}]",Current medical research and opinion,['10.1080/03007995.2020.1803248']
1725,32739704,Aerobic exercise or stretching as add-on to inpatient treatment of depression: Similar antidepressant effects on depressive symptoms and larger effects on working memory for aerobic exercise alone.,"BACKGROUND


Aerobic exercise (AE) has positive effects on symptom severity and cognitive symptoms of depression. Since data on AE as add-on to inpatient treatment in depression is still scarce, we conducted this double-blind randomized controlled study.
METHODS


Patients aged between 18 and 60 years were recruited into the study if Hamilton Depression Rating Scale 17 (HDRS-17) score was >16. Participants were randomly assigned to either AE or basic stretching activities (control), which took place 3x/week for 6 weeks. Primary outcome was depression severity as assessed with the HDRS-17 and the Beck Depression Inventory (BDI). Further physiological and psychological variables and cognitive performance were assessed as secondary outcomes.
RESULTS


Forty-two patients were included in the analysis (exercise: n = 22; control: n = 20). Regardless of group allocation, we found a significant short-term time effect for symptom-severity (HDRS17: p<0.001, η²=0.70; BDI: p<0.001, η²=0.51), mental toughness (p<0.001, η²=0.32), physical self-description endurance score (p = 0.013, η²=0.16), cognitive flexibility (p = 0.013, η²=0.14), and body mass index (BMI) (p = 0.006, η²=0.19). Working memory showed a significant time by group interaction in favor of AE (p = 0.043, η²=0.10). Short-term effects on symptom severity, mental toughness and BMI remained stable across the 6-month follow-up period. Finally, self-reported physical activity increased significantly from baseline to follow-up (p = 0.014, η²=0.15).
LIMITATIONS


The sample-size is rather small. The control intervention might have been too active as to find a time by group interaction for symptom severity.
CONCLUSIONS


AE was associated with comparably large depression alleviation vs. stretching and with add-on benefits on working memory.",2020,"Short-term effects on symptom severity, mental toughness and BMI remained stable across the 6-month follow-up period.","['Forty-two patients were included in the analysis (exercise: n\xa0=\xa022; control: n\xa0=\xa020', 'Patients aged between 18 and 60 years']","['Aerobic exercise or stretching', 'Aerobic exercise (AE', 'AE or basic stretching activities (control', 'aerobic exercise alone']","['mental toughness', 'depression severity as assessed with the HDRS-17 and the Beck Depression Inventory (BDI', 'physical activity', 'symptom severity, mental toughness and BMI', 'physical self-description endurance score', 'Hamilton Depression Rating Scale 17 (HDRS-17) score', 'cognitive flexibility', 'body mass index (BMI']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",42.0,0.225194,"Short-term effects on symptom severity, mental toughness and BMI remained stable across the 6-month follow-up period.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Imboden', 'Affiliation': 'Psychiatric Services Solothurn, Solothurn, Switzerland, and University of Basel, Basel, Switzerland; Private Clinic Wyss, Muenchenbuchsee, Switzerland. Electronic address: christian.imboden@pkwyss.ch.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gerber', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Beck', 'Affiliation': 'Psychiatric University Hospital, University of Basel, Basel, Switzerland; Private Clinic Sonnenhalde, Riehen, Switzerland.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Holsboer-Trachsler', 'Affiliation': 'Psychiatric University Hospital, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Pühse', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hatzinger', 'Affiliation': 'Psychiatric Services Solothurn, Solothurn, Switzerland, and University of Basel, Basel, Switzerland.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.052']
1726,32739716,The comparison of access to an eHealth resource to current practice on mother and co-parent teamwork and breastfeeding rates: A randomized controlled trial.,"BACKGROUND


Breastfeeding rates are suboptimal, putting mothers and their infants' health at risk. One modifiable risk factor amenable to intervention is partner support. Having women work as a team with their co-parents to meet their breastfeeding goals has been found to improve breastfeeding outcomes. eHealth resources have been found to be accessible and feasible ways to provide breastfeeding education yet, the best way to design breastfeeding interventions for mothers and their co-parents is not known.
OBJECTIVES


To compare two study conditions to determine: (1) which way is more effective to provide breastfeeding education to women and their co-parents on increasing breastfeeding rates and associated secondary outcomes, such as breastfeeding knowledge, attitude, self-efficacy and overcoming challenges; (2) the difference in co-parenting and partner support between the study groups; (3) how parents in both groups preferred to access breastfeeding information; and (4) the groups' satisfaction with the eHealth resource that was provided.
DESIGN


This study used a randomized controlled trial design (Clinicaltrials.org #NCT03492411). Participants were randomly allocated to study groups with concealed opaque envelopes by a blinded research assistant. Participants in Study Condition #1 (SC1) accessed a previously created, online e-Health resource, in addition to other generally available resources they could access in the community; participants in Study Condition #2 (SC2) accessed only the generally available resources.
SETTING


Participants were recruited in health care providers' offices and services for expectant parents in Ontario and via social media throughout Canada.
PARTICIPANTS


Expectant women (n = 113) and their co-parents (n = 104) were enrolled.
METHODS


After eligibility was determined, consents obtained and baseline surveys completed, group allocation was conducted. SC1 had a virtual meeting with a research assistant to review the eHealth resource. Weekly emails were sent to all participants for 6 weeks as reminders. Follow-up data were electronically collected from mothers and co-parents at 2 weeks post enrollment and 4, 12, 26 and 52-weeks postpartum.
RESULTS


Breastfeeding rates were high in both groups (SC1 63% and SC2 57% 'exclusive' 6 months) and (SC1 71% and SC2 78% 'any' 12 months) and not statistically significantly different. High scores were found in both groups in secondary outcome measures. Generally available breastfeeding resources were used in both groups with websites being used often and rated as most helpful. SC1 rated the eHealth resource provided to them highly.
CONCLUSION


The findings suggest both mothers and their co-parents should be targeted in breastfeeding education and web-based resources designed to meet their needs.",2020,"RESULTS


Breastfeeding rates were high in both groups (SC1 63% and SC2 57% 'exclusive' 6 months) and (SC1 71% and SC2 78% 'any' 12 months) and not statistically significantly different.","['Expectant women (n\xa0=\xa0113) and their co-parents (n\xa0=\xa0104) were enrolled', 'Participants in Study Condition', ""Participants were recruited in health care providers' offices and services for expectant parents in Ontario and via social media throughout Canada""]",[],['Breastfeeding rates'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]",[],"[{'cui': 'C0006147', 'cui_str': 'Breast fed'}]",104.0,0.0703829,"RESULTS


Breastfeeding rates were high in both groups (SC1 63% and SC2 57% 'exclusive' 6 months) and (SC1 71% and SC2 78% 'any' 12 months) and not statistically significantly different.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Abbass-Dick', 'Affiliation': 'Faculty of Health Sciences, Ontario Tech University, 2000 Simcoe Street North, Oshawa ON, L1G 0C5, Canada. Electronic address: jennifer.abbassdick@ontariotechu.ca.'}, {'ForeName': 'Winnie', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Faculty of Health Sciences, Ontario Tech University, 2000 Simcoe Street North, Oshawa ON, L1G 0C5, Canada.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Newport', 'Affiliation': 'Durham Region Health Department, Canada.'}, {'ForeName': 'Fangli', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Durham Region Health Department, Canada.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Godfrey', 'Affiliation': 'Durham Region Health Department, Canada.'}, {'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Goodman', 'Affiliation': 'Faculty of Business and Information Technology, Ontario Tech University.'}]",Midwifery,['10.1016/j.midw.2020.102812']
1727,32739862,Benefits of social cognitive skills training within routine community mental health services: Evidence from a non-randomized parallel controlled study.,"Although social cognitive impairments are evident in patients with schizophrenia across many cultures, psychosocial interventions are less used in Eastern countries. Despite a growing emphasis on community care in mental health services in Eastern countries, the synergistic effects of social cognitive intervention strategies on routine community mental health services are not well documented. This study aimed to adapt a group-based social cognitive skills training (SCST) program for use in a Korean context and evaluate its feasibility and preliminary effects among community-dwelling individuals with schizophrenia. Forty-seven patients were assigned to either the SCST + treatment as usual (TAU) group (n = 21) or the TAU only group (n = 24). Participants completed tasks to assess social cognition, social functioning, neurocognition, and psychiatric symptoms before and after treatment. Over a period of approximately 12 weeks, drop-out rates were comparably low in both groups, and the attendance rates for the SCST program were high (85.7 %, mean sessions attended = 20.56/24 sessions). The SCST + TAU group demonstrated significant improvements in facial affect recognition, social functioning, and psychiatric symptoms compared to the TAU only group. A non-significant trend in theory of mind was observed, along with no improvements in social perception and neurocognition. The adapted version of the SCST program is feasible for implementation and demonstrates promise for enhancing social cognition and functioning in Korean outpatients with schizophrenia.",2020,The adapted version of the SCST program is feasible for implementation and demonstrates promise for enhancing social cognition and functioning in Korean outpatients with schizophrenia.,"['mental health services in Eastern countries', 'community-dwelling individuals with schizophrenia', 'Korean outpatients with schizophrenia', 'Forty-seven patients', 'routine community mental health services', 'patients with schizophrenia']","['TAU', 'social cognitive skills training', 'social cognitive skills training (SCST) program', 'SCST + TAU', 'SCST program', 'SCST + treatment as usual (TAU']","['social cognition, social functioning, neurocognition, and psychiatric symptoms', 'facial affect recognition, social functioning, and psychiatric symptoms', 'attendance rates', 'social perception and neurocognition']","[{'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009475', 'cui_str': 'Mental Health Services, Community'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0579088', 'cui_str': 'Cognitive skills training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0037427', 'cui_str': 'Perception, Social'}]",47.0,0.0204504,The adapted version of the SCST program is feasible for implementation and demonstrates promise for enhancing social cognition and functioning in Korean outpatients with schizophrenia.,"[{'ForeName': 'Jae Eun', 'Initials': 'JE', 'LastName': 'Lim', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Ye-Jin', 'Initials': 'YJ', 'LastName': 'Kwon', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Soo-Yun', 'Initials': 'SY', 'LastName': 'Jung', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea.'}, {'ForeName': 'Kiho', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea; Korea University Mind Health Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Wonhye', 'Initials': 'W', 'LastName': 'Lee', 'Affiliation': 'Department of Clinical Psychology, National Center for Mental Health, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Hwan', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Inje University Ilsan-Paik Hospital, Goyang, Republic of Korea.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'P Horan', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Kee-Hong', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': 'Department of Psychology, Korea University, Seoul, Republic of Korea; Korea University Mind Health Institute, Seoul, Republic of Korea; Department of Psychology, Wesleyan University, Middletown, USA. Electronic address: kchoi1@korea.ac.kr.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102314']
1728,32740972,Dexamethasone therapy in COVID-19 patients: implications and guidance for the management of blood glucose in people with and without diabetes.,"The RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial found that dexamethasone 6 mg once per day for 10 days reduced deaths by one-third in ventilated patients and by one-fifth in other patients, receiving oxygen therapy. This equates to the prevention of one death in around eight ventilated patients, or one in around 25 patients requiring oxygen.",2020,"The RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial found that dexamethasone 6 mg once per day for 10 days reduced deaths by one-third in ventilated patients and by one-fifth in other patients, receiving oxygen therapy.","['eight ventilated patients, or one in around 25 patients requiring oxygen', 'COVID-19 patients', 'people with and without diabetes']","['dexamethasone', 'Dexamethasone therapy']",['deaths'],"[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}]",25.0,0.0717853,"The RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial found that dexamethasone 6 mg once per day for 10 days reduced deaths by one-third in ventilated patients and by one-fifth in other patients, receiving oxygen therapy.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rayman', 'Affiliation': 'The Ipswich Diabetes Centre, East Suffolk and North Essex NHS Foundation Trust, Colchester, United Kingdom.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Lumb', 'Affiliation': 'Churchill Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kennon', 'Affiliation': 'Department of Diabetes, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cottrell', 'Affiliation': 'Swansea Bay University Health Board, Port Talbot, United Kingdom.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Nagi', 'Affiliation': 'Mid Yorkshire Hospital NHS Trust, Wakefield, United Kingdom.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Page', 'Affiliation': 'Diabetes Centre, Ipswich Hospital NHS Trust, Ipswich, United Kingdom.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Voigt', 'Affiliation': 'Ninewells Hospital, NHS Tayside, Dundee, United Kingdom.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Courtney', 'Affiliation': 'Belfast Health and Social Care Trust, Belfast, United Kingdom.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Atkins', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Platts', 'Affiliation': 'Cardiff and Vale University Health Board, Cardiff, United Kingdom.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Higgins', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, United Kingdom.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dhatariya', 'Affiliation': 'Diabetes Centre, Norfolk & Norwich University Hospital NHS Trust, Norwich, United Kingdom.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Narendran', 'Affiliation': 'Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Kar', 'Affiliation': 'NHS Diabetes Programme, NHS England, London, United Kingdom.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Newland-Jones', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Stewart', 'Affiliation': 'Gladstone Centre, Wrexham Maelor Hospital, Wrexham, United Kingdom.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Burr', 'Affiliation': 'Diabetes UK, London, United Kingdom.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': ""Diabetes Centre King's College Hospital, London, United Kingdom.""}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14378']
1729,32741328,Secondary Injury Prevention Program May Decrease Contralateral Anterior Cruciate Ligament Injuries in Female Athletes: 2-year Injury Rates in the ACL-SPORTS Randomized Control Trial.,"OBJECTIVE


To determine if the addition of perturbation training to a secondary injury prevention program reduced the rate of second anterior cruciate ligament (ACL) injuries compared to the prevention program alone.
DESIGN


Single-blinded randomized control trial.
METHODS


Thirty-nine female athletes who intended to return to cutting/pivoting sports were enrolled 3-9 months after primary ACLR. Athletes were randomized into either progressive strengthening, agility, plyometric, and prevention (SAPP) or SAPP plus perturbation training (SAPP+PERT) groups; each had ten sessions over 5 weeks. Occurrence and side of second ACL injury were recorded for two years after primary ACLR.
RESULTS


There were nine second ACL injuries in the two years after ACLR. There was no statistically significant difference in rate or side of second ACL injury between the SAPP+PERT and SAPP groups.
CONCLUSION


Adding perturbation training to a secondary ACL injury prevention program did not affect the rate of second ACL injuries in female athletes.  J Orthop Sports Phys Ther, Epub 1 Aug 2020. doi:10.2519/jospt.2020.9407 .",2020,"There was no statistically significant difference in rate or side of second ACL injury between the SAPP+PERT and SAPP groups.
","['Thirty-nine female athletes who intended to return to cutting/pivoting sports were enrolled 3-9 months after primary ACLR', 'female athletes', 'Female Athletes']","['perturbation training to a secondary injury prevention program', 'progressive strengthening, agility, plyometric, and prevention (SAPP) or SAPP plus perturbation training (SAPP+PERT']","['Occurrence and side of second ACL injury', 'Contralateral Anterior Cruciate Ligament Injuries', 'rate or side of second ACL injury', 'rate of second ACL injuries', 'rate of second anterior cruciate ligament (ACL) injuries']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1456574', 'cui_str': 'Injury of anterior cruciate ligament'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",39.0,0.0258922,"There was no statistically significant difference in rate or side of second ACL injury between the SAPP+PERT and SAPP groups.
","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Johnson', 'Affiliation': 'Biomechanics and Movement Science, University of Delaware, Newark DE.'}, {'ForeName': 'Jacob J', 'Initials': 'JJ', 'LastName': 'Capin', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark DE.'}, {'ForeName': 'Amelia J H', 'Initials': 'AJH', 'LastName': 'Arundale', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark DE.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarzycki', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark DE.'}, {'ForeName': 'Angela H', 'Initials': 'AH', 'LastName': 'Smith', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark DE.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Snyder-Mackler', 'Affiliation': 'Biomechanics and Movement Science, University of Delaware, Newark DE.'}]",The Journal of orthopaedic and sports physical therapy,['10.2519/jospt.2020.9407']
1730,32741789,"Te.M.P.O., an app for using temporal musical mismatch in post stroke neurorehabilitation: A preliminary randomized controlled study.","BACKGROUND


Recently, the potential rehabilitation value of music has been examined and music-based interventions and techniques such as the Negative Mismatch (MMN) have been increasingly investigated in the neurological rehabilitation context.
OBJECTIVE


The aim of this study was to investigate the effectiveness of a negative mismatch-based therapy on the disability and quality of life in patients with stroke in sub-acute phase.
METHODS


Thirty patients with a stroke diagnosis in sub-acute phase were randomly assigned to one of two groups: Mismatch (Mg) or Control (CTRLg) group. Both groups used an innovative Android application: Temporal Musical Patterns Organisation (Te.M.P.O). The Disability Rating Scale (DRS), the Modified Barthel Index (MBI) and the Stroke Specific Quality of Life scale (SSQoL) were used at the baseline (T0) and after four weeks of training (T1), in order to assess changes over time.
RESULTS


Statistical analysis was performed using the data of 24 (Mg = 12, CTRLg = 12) subjects. The results show a major improvement of the Mg with respect to the CTRLg in all clinical scales score.
CONCLUSION


The temporal negative mismatch-based therapy performed with the Te.M.P.O. application could be useful in improving the disability and the quality of life in stroke survivors in a sub-acute phase.",2020,"The Disability Rating Scale (DRS), the Modified Barthel Index (MBI) and the Stroke Specific Quality of Life scale (SSQoL) were used at the baseline (T0) and after four weeks of training (T1), in order to assess changes over time.
","['patients with stroke in sub-acute phase', 'Thirty patients with a stroke diagnosis in sub-acute phase']","['Mismatch (Mg) or Control (CTRLg', 'negative mismatch-based therapy']","['disability and quality of life', 'Disability Rating Scale (DRS), the Modified Barthel Index (MBI) and the Stroke Specific Quality of Life scale (SSQoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0439557', 'cui_str': 'Acute phase'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0451125', 'cui_str': 'Disability rating scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}]",30.0,0.0341592,"The Disability Rating Scale (DRS), the Modified Barthel Index (MBI) and the Stroke Specific Quality of Life scale (SSQoL) were used at the baseline (T0) and after four weeks of training (T1), in order to assess changes over time.
","[{'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Verna', 'Affiliation': 'Fondazione Santa Lucia IRCCS, Rome, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'De Bartolo', 'Affiliation': 'PhD Program in Behavioral Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Iosa', 'Affiliation': 'Fondazione Santa Lucia IRCCS, Rome, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Fadda', 'Affiliation': 'Fondazione Santa Lucia IRCCS, Rome, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pinto', 'Affiliation': 'Fondazione Santa Lucia IRCCS, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Caltagirone', 'Affiliation': 'Fondazione Santa Lucia IRCCS, Rome, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'De Angelis', 'Affiliation': 'Fondazione Santa Lucia IRCCS, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Tramontano', 'Affiliation': 'Fondazione Santa Lucia IRCCS, Rome, Italy.'}]",NeuroRehabilitation,['10.3233/NRE-203126']
1731,32720695,Effects of Pregnancy and Isoniazid Preventive Therapy on M. tuberculosis Interferon Gamma Response Assays in Women with HIV.,"BACKGROUND


Pregnancy is accompanied by immune suppression. We hypothesized that M. tuberculosis-specific inflammatory responses used to identify latent tuberculosis infection (LTBI) lose positivity during pregnancy. We also hypothesized that isoniazid preventive therapy (IPT) may revert LTBI diagnoses because of its sterilizing activity.
METHODS


944 women with HIV participating in a randomized, double-blind, placebo-controlled study comparing 28 weeks of IPT antepartum versus postpartum, were tested by QuantiFERON-gold-in-tube (QGIT) antepartum and by QGIT and tuberculin skin test (TST) at delivery and postpartum. Serial QGIT positivity was assessed by logistic regression using generalized estimating equations.
RESULTS


From entry to delivery, 68 (24%) of 284 QGIT-positive women (24%) reverted to QGIT-negative or indeterminate. Of these, 42 (62%) recovered QGIT positivity postpartum. The loss of QGIT positivity during pregnancy was explained by decreased IFNγ production in response to TB antigen and/or mitogen. At delivery, QGIT identified 205 and TST 113 women with LTBI. Corresponding numbers postpartum were 229 and 122 women. QGIT and TST kappa agreement coefficients were 0.4 and 0.5, respectively. Among QGIT-positive women antepartum or at delivery, 34 (12%) reverted to QGIT-negative after IPT. There were no differences between women who initiated IPT antepartum or postpartum.
CONCLUSIONS


Decreased IFNγ responses in pregnancy reduced QGIT positivity, suggesting that this test cannot reliably rule out LTBI during pregnancy. TST was less affected by pregnancy, but had lower positivity compared to QGIT at all time points. IPT was associated with loss of QGIT positivity, the potential clinical consequences of which need to be investigated.",2020,"TST was less affected by pregnancy, but had lower positivity compared to QGIT at all time points.","['Women with HIV', 'Corresponding numbers postpartum were 229 and 122 women', '944 women with HIV participating']","['IPT', 'Pregnancy and Isoniazid Preventive Therapy', 'IPT antepartum versus postpartum, were tested by QuantiFERON-gold-in-tube (QGIT) antepartum and by QGIT and tuberculin skin test (TST', 'isoniazid preventive therapy (IPT', 'placebo']","['Serial QGIT positivity', 'QGIT and TST kappa agreement coefficients', 'IPT antepartum or postpartum', 'QGIT positivity postpartum', 'TST', 'loss of QGIT positivity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0456336', 'cui_str': 'Antepartum'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439099', 'cui_str': 'Kappa'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0456336', 'cui_str': 'Antepartum'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}]",944.0,0.21607,"TST was less affected by pregnancy, but had lower positivity compared to QGIT at all time points.","[{'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Weinberg', 'Affiliation': 'Department of Pediatrics, Medicine and Pathology, University of Colorado Anschutz Medical Campus, Aurora, CO.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Aaron', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Montepiedra', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, USA.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Sterling', 'Affiliation': 'Vanderbilt Tuberculosis Center, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Browning', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Blandina', 'Initials': 'B', 'LastName': 'Mmbaga', 'Affiliation': 'Kilimanjaro Christian Medical Centre (KCMC) Moshi,\xa0Tanzania.'}, {'ForeName': 'Tichaona', 'Initials': 'T', 'LastName': 'Vhembo', 'Affiliation': 'University of Zimbabwe College of Health Sciences Clinical Trials Research Centre (UZCHS-CTRC), Harare, Zimbabwe.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Naik', 'Affiliation': 'Department of Obstetrics and Gynaecology, BJGMC, Pune, India.'}, {'ForeName': 'Enid', 'Initials': 'E', 'LastName': 'Kabugho', 'Affiliation': 'Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Gaerolwe', 'Initials': 'G', 'LastName': 'Masheto', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership and Harvard T.H. Chan School of Public Health.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Pahwa', 'Affiliation': 'Department of Microbiology and Immunology, University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Jyoti S', 'Initials': 'JS', 'LastName': 'Mathad', 'Affiliation': 'Department of Medicine, Center for Global Health, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Sylvia M', 'Initials': 'SM', 'LastName': 'LaCourse', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'McCarthy', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bradford', 'Affiliation': 'FHI 360, Durham, NC, USA.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Theron', 'Affiliation': 'FAM-CRU CRS, Department of Obstetrics and Gynaecology, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Costello', 'Affiliation': 'University of California Los Angeles, Los Angeles CA, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Zimmer', 'Affiliation': 'Frontier Science Foundation, Amherst NY, USA.'}, {'ForeName': 'Marie F', 'Initials': 'MF', 'LastName': 'Pierre', 'Affiliation': 'Les Centres GHESKIO, Port-au-Prince, Haïti.'}, {'ForeName': 'Kamunkhwala', 'Initials': 'K', 'LastName': 'Gausi', 'Affiliation': 'Division of Clinical Pharmacology, University of Cape Town, South Africa.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Denti', 'Affiliation': 'Division of Clinical Pharmacology, University of Cape Town, South Africa.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Haas', 'Affiliation': 'Vanderbilt Tuberculosis Center, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Departments of Medicine and International Health, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1083']
1732,32720911,The Assessment of Supportive Accountability in Adults Seeking Obesity Treatment: Psychometric Validation Study.,"BACKGROUND


Technology-mediated obesity treatments are commonly affected by poor long-term adherence. Supportive Accountability Theory suggests that the provision of social support and oversight toward goals may help to maintain adherence in technology-mediated treatments. However, no tool exists to measure the construct of supportive accountability.
OBJECTIVE


This study aimed to develop and psychometrically validate a supportive accountability measure (SAM) by examining its performance in technology-mediated obesity treatment.
METHODS


Secondary data analyses were conducted in 2 obesity treatment studies to validate the SAM (20 items). Study 1 examined reliability, criterion validity, and construct validity using an exploratory factor analysis in individuals seeking obesity treatment. Study 2 examined the construct validity of SAM in technology-mediated interventions involving different self-monitoring tools and varying amounts of phone-based interventionist support. Participants received traditional self-monitoring tools (standard, in-home self-monitoring scale [SC group]), newer, technology-based self-monitoring tools (TECH group), or these newer technology tools plus additional phone-based support (TECH+PHONE group). Given that the TECH+PHONE group involves more interventionist support, we hypothesized that this group would have greater supportive accountability than the other 2 arms.
RESULTS


In Study 1 (n=353), the SAM showed strong reliability (Cronbach α=.92). A factor analysis revealed a 3-factor solution (representing Support for Healthy Eating Habits, Support for Exercise Habits, and Perceptions of Accountability) that explained 69% of the variance. Convergent validity was established using items from the motivation for weight loss scale, specifically the social regulation subscale (r=0.33; P<.001) and social pressure for weight loss subscale (r=0.23; P<.001). In Study 2 (n=80), the TECH+PHONE group reported significantly higher SAM scores at 6 months compared with the SC and TECH groups (r 2 =0.45; P<.001). Higher SAM scores were associated with higher adherence to weight management behaviors, including higher scores on subscales representing healthy dietary choices, the use of self-monitoring strategies, and positive psychological coping with weight management challenges. The association between total SAM scores and percent weight change was in the expected direction but not statistically significant (r=-0.26; P=.06).
CONCLUSIONS


The SAM has strong reliability and validity across the 2 studies. Future studies may consider using the SAM in technology-mediated weight loss treatment to better understand whether support and accountability are adequately represented and how supportive accountability impacts treatment adherence and outcomes.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01999244; https://clinicaltrials.gov/ct2/show/NCT01999244.",2020,"Higher SAM scores were associated with higher adherence to weight management behaviors, including higher scores on subscales representing healthy dietary choices, the use of self-monitoring strategies, and positive psychological coping with weight management challenges.","['Adults Seeking Obesity Treatment', 'individuals seeking obesity treatment']","['TECH+PHONE', 'traditional self-monitoring tools (standard, in-home self-monitoring scale [SC group]), newer, technology-based self-monitoring tools (TECH group), or these newer technology tools plus additional phone-based support (TECH+PHONE group']","['total SAM scores and percent weight change', 'Higher SAM scores', 'supportive accountability', 'social regulation subscale', 'SAM scores', 'social pressure for weight loss subscale']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0078889', 'cui_str': 'Accountability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0390713,"Higher SAM scores were associated with higher adherence to weight management behaviors, including higher scores on subscales representing healthy dietary choices, the use of self-monitoring strategies, and positive psychological coping with weight management challenges.","[{'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Chhabria', 'Affiliation': 'The Center for Health Care Data, Department of Management, Policy and Community Health, University of Texas Health Science Center at Houston, Houston, TX, United States.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Ross', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Shane J', 'Initials': 'SJ', 'LastName': 'Sacco', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, Storrs, CT, United States.'}, {'ForeName': 'Tricia M', 'Initials': 'TM', 'LastName': 'Leahey', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, Storrs, CT, United States.'}]",Journal of medical Internet research,['10.2196/17967']
1733,32723265,Electrophysiological and Clinical Improvement in Non-Invasive Treatment of Carpal Tunnel Syndrome.,"BACKGROUND AND OBJECTIVE


Carpal tunnel syndrome (CTS) is the most common form of nerve entrapment. Clinically, various signs and symptoms compare due to overexposure to mechanical vibrations transmitted to the wrist bones and cartilage, resulting in compression of the sensory and motor nerve fibers of median nerve. Early symptoms include nocturnal paresthesia and electromyography reveals reduced sensory nerve conduction velocity. Aim of this study was to evaluate the efficacy of a dietary integrator composed of acetyl-L-carnitine, α-lipoic acid,quercetin, bromelain, pantothenic acid, C and B1 and B2 and B6 and B12 vitamins in patients with early (minimal) carpal tunnel syndrome.
METHODS


36 patients (28 female and 8 male) with early CTS characterized by sensory nerve demyelination and inflammation of the transverse carpal ligament. Patients were divided into two groups, group A (18 patients received physical therapy) and group B (18 patients, received physical therapy and an oral integrator). Clinical (sleep quality questionnaire to measure severity of paresthesia) and neurophysiological assessment (Sensory Nerve Conduction Velocity) performed at baseline, and then at 30 and 60 days after treatment.
RESULTS


Sleep quality and Sensory Nerve Conduction Velocity data analysis show improvement in both groups at 30 and 60 days, with statistically difference between them in both time of analysis.
CONCLUSIONS


In the early CTS, with sensory fibers damage, use of dietary integrator, such as Micronil Dol®, composed composed of acetyl-L-carnitine, α-lipoic acid,quercetin, bromelain, pantothenic acid, C and B1 and B2 and B6 and B12 vitamins can be effective in quick recovery of median nerve sensory.",2020,"RESULTS


Sleep quality and Sensory Nerve Conduction Velocity data analysis show improvement in both groups at 30 and 60 days, with statistically difference between them in both time of analysis.
","['patients with early (minimal) carpal tunnel syndrome', '36 patients (28 female and 8 male) with early CTS characterized by sensory nerve demyelination and inflammation of the transverse carpal ligament', 'Non-Invasive Treatment of Carpal Tunnel Syndrome', 'Carpal tunnel syndrome (CTS']","['physical therapy and an oral integrator', 'dietary integrator composed of acetyl-L-carnitine, α-lipoic acid,quercetin, bromelain, pantothenic acid, C and B1 and B2 and B6 and B12 vitamins', 'physical therapy']","['Sleep quality and Sensory Nerve Conduction Velocity data analysis', 'Clinical (sleep quality questionnaire to measure severity of paresthesia) and neurophysiological assessment (Sensory Nerve Conduction Velocity', 'sensory nerve conduction velocity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0011304', 'cui_str': 'Demyelination'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C0007285', 'cui_str': 'Bone structure of carpus'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0001040', 'cui_str': 'Acetylcarnitine'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0034392', 'cui_str': 'Quercetin'}, {'cui': 'C0006217', 'cui_str': 'Bromelains'}, {'cui': 'C0030342', 'cui_str': 'Pantothenic Acid'}, {'cui': 'C1261069', 'cui_str': 'Structure of left apicoposterior segmental bronchus'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}]","[{'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0457378', 'cui_str': 'Sensory nerve conduction velocity'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0296892,"RESULTS


Sleep quality and Sensory Nerve Conduction Velocity data analysis show improvement in both groups at 30 and 60 days, with statistically difference between them in both time of analysis.
","[{'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Marvulli', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sensory Organs, University of Bari ""Aldo Moro"", Policlinico of Bari, Piazza G. Cesare 11, 70124 Bari. Italy.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Ianieri', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sensory Organs, University of Bari ""Aldo Moro"", Policlinico of Bari, Piazza G. Cesare 11, 70124 Bari. Italy.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'De Venuto', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sensory Organs, University of Bari ""Aldo Moro"", Policlinico of Bari, Piazza G. Cesare 11, 70124 Bari. Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Falcicchio', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sensory Organs, University of Bari ""Aldo Moro"", Policlinico of Bari, Piazza G. Cesare 11, 70124 Bari. Italy.'}, {'ForeName': 'Giulia A', 'Initials': 'GA', 'LastName': 'Gallo', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sensory Organs, University of Bari ""Aldo Moro"", Policlinico of Bari, Piazza G. Cesare 11, 70124 Bari. Italy.'}, {'ForeName': 'Catia', 'Initials': 'C', 'LastName': 'Mennuni', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sensory Organs, University of Bari ""Aldo Moro"", Policlinico of Bari, Piazza G. Cesare 11, 70124 Bari. Italy.'}, {'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Gallone', 'Affiliation': 'Local Healthcare Company, Bari-Health District, Bari,. Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Fiore', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sensory Organs, University of Bari ""Aldo Moro"", Policlinico of Bari, Piazza G. Cesare 11, 70124 Bari. Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Ranieri', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sensory Organs, University of Bari ""Aldo Moro"", Policlinico of Bari, Piazza G. Cesare 11, 70124 Bari. Italy.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Megna', 'Affiliation': 'Department of Basic Medical Sciences, Neuroscience and Sensory Organs, University of Bari ""Aldo Moro"", Policlinico of Bari, Piazza G. Cesare 11, 70124 Bari. Italy.'}]","Endocrine, metabolic & immune disorders drug targets",['10.2174/1871530320666200728152953']
1734,32723718,Haptic Nudges Increase Affected Upper Limb Movement During Inpatient Stroke Rehabilitation: Multiple-Period Randomized Crossover Study.,"BACKGROUND


As many as 80% of stroke survivors experience upper limb (UL) disability. The strong relationships between disability, lost productivity, and ongoing health care costs mean reducing disability after stroke is critical at both individual and society levels. Unfortunately, the amount of UL-focused rehabilitation received by people with stroke is extremely low. Activity monitoring and promotion using wearable devices offer a potential technology-based solution to address this gap. Commonly, wearable devices are used to deliver a haptic nudge to the wearer with the aim of promoting a particular behavior. However, little is known about the effectiveness of haptic nudging in promoting behaviors in patient populations.
OBJECTIVE


This study aimed to estimate the effect of haptic nudging delivered via a wrist-worn wearable device on UL movement in people with UL disability following stroke undertaking inpatient rehabilitation.
METHODS


A multiple-period randomized crossover design was used to measure the association of UL movement with the occurrence of haptic nudge reminders to move the affected UL in 20 people with stroke undertaking inpatient rehabilitation. UL movement was observed and classified using movement taxonomy across 72 one-minute observation periods from 7:00 AM to 7:00 PM on a single weekday. On 36 occasions, a haptic nudge to move the affected UL was provided just before the observation period. On the other 36 occasions, no haptic nudge was given. The timing of the haptic nudge was randomized across the observation period for each participant. Statistical analysis was performed using mixed logistic regression. The effect of a haptic nudge was evaluated from the intention-to-treat dataset as the ratio of the odds of affected UL movement during the observation period following a ""Planned Nudge"" to the odds of affected limb movement during the observation period following ""No Nudge.""
RESULTS


The primary intention-to-treat analysis showed the odds ratio (OR) of affected UL movement following a haptic nudge was 1.44 (95% CI 1.28-1.63, P<.001). The secondary analysis revealed an increased odds of affected UL movement following a Planned Nudge was predominantly due to increased odds of spontaneous affected UL movement (OR 2.03, 95% CI 1.65-2.51, P<.001) rather than affected UL movement in conjunction with unaffected UL movement (OR 1.13, 95% CI 0.99-1.29, P=.07).
CONCLUSIONS


Haptic nudging delivered via a wrist-worn wearable device increases affected UL movement in people with UL disability following stroke undertaking inpatient rehabilitation. The promoted movement appears to be specific to the instructions given.
TRIAL REGISTRATION


Australia New Zealand Clinical Trials Registry 12616000654459; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=370687&isReview=true.",2020,"The secondary analysis revealed an increased odds of affected UL movement following a Planned Nudge was predominantly due to increased odds of spontaneous affected UL movement (OR 2.03, 95% CI 1.65-2.51, P<.001) rather than affected UL movement in conjunction with unaffected UL movement (OR 1.13, 95% CI 0.99-1.29, P=.07).
","['20 people with stroke undertaking inpatient rehabilitation', 'people with UL disability following stroke undertaking inpatient rehabilitation']","['haptic nudging delivered via a wrist-worn wearable device', 'Haptic nudging delivered via a wrist-worn wearable device', 'haptic nudge']","['Upper Limb Movement', 'odds ratio (OR) of affected UL movement']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C4505348', 'cui_str': 'Wearable Technology'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}]",20.0,0.185218,"The secondary analysis revealed an increased odds of affected UL movement following a Planned Nudge was predominantly due to increased odds of spontaneous affected UL movement (OR 2.03, 95% CI 1.65-2.51, P<.001) rather than affected UL movement in conjunction with unaffected UL movement (OR 1.13, 95% CI 0.99-1.29, P=.07).
","[{'ForeName': 'Nada Elizabeth June', 'Initials': 'NEJ', 'LastName': 'Signal', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'McLaren', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Rashid', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Vandal', 'Affiliation': 'Department of Statistics, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Callaghan Innovation, Christchurch, New Zealand.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Almesfer', 'Affiliation': 'Exsurgo Rehabilitation, Auckland, New Zealand.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'Assessment, Treatment and Rehabilitation Department, Waitakere Hospital, Waitemata District Health Board, Auckland, New Zealand.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Taylor', 'Affiliation': 'Health and Rehabilitation Research Institute, Auckland University of Technology, Auckland, New Zealand.'}]",JMIR mHealth and uHealth,['10.2196/17036']
1735,32723722,Virtual Reality Smartphone-Based Intervention for Smoking Cessation: Pilot Randomized Controlled Trial on Initial Clinical Efficacy and Adherence.,"BACKGROUND


Obstacles to current tobacco cessation programs include limited access and adherence to effective interventions. Digital interventions offer a great opportunity to overcome these difficulties, yet virtual reality has not been used as a remote and self-administered tool to help increase adherence and effectiveness of digital interventions for tobacco cessation.
OBJECTIVE


This study aimed to evaluate participant adherence and smoking cessation outcomes in a pilot randomized controlled trial of the digital intervention Mindcotine (MindCotine Inc) using a self-administered treatment of virtual reality combined with mindfulness.
METHODS


A sample of 120 participants was recruited in the city of Buenos Aires, Argentina (mean age 43.20 years, SD 9.50; 57/120, 47.5% female). Participants were randomly assigned to a treatment group (TG), which received a self-assisted 21-day program based on virtual reality mindful exposure therapy (VR-MET) sessions, daily surveys, and online peer-to-peer support moderated by psychologists, or a control group (CG), which received the online version of the smoking cessation manual from the Argentine Ministry of Health. Follow-up assessments were conducted by online surveys at postintervention and 90-day follow-up. The primary outcome was self-reported abstinence at postintervention, with missing data assumed as still smoking. Secondary outcomes included sustained abstinence at 90-day follow-up, adherence to the program, and readiness to quit.
RESULTS


Follow-up rates at day 1 were 93% (56/60) for the TG and 100% (60/60) for the CG. At postintervention, the TG reported 23% (14/60) abstinence on that day compared with 5% (3/60) in the CG. This difference was statistically significant (χ 2 1 =8.3; P=.004). The TG reported sustained abstinence of 33% (20/60) at 90 days. Since only 20% (12/60) of participants in the CG completed the 90-day follow-up, we did not conduct a statistical comparison between groups at this follow-up time point. Among participants still smoking at postintervention, the TG was significantly more ready to quit compared to the CG (TG: mean 7.71, SD 0.13; CG: mean 7.16, SD 0.13; P=.005). A total of 41% (23/56) of participants completed the treatment in the time frame recommended by the program.
CONCLUSIONS


Results provide initial support for participant adherence to and efficacy of Mindcotine and warrant testing the intervention in a fully powered randomized trial. However, feasibility of trial follow-up assessment procedures for control group participants needs to be improved. Further research is needed on the impact of VR-MET on long-term outcomes.
TRIAL REGISTRATION


ISRCTN Registry ISRCTN50586181; http://www.isrctn.com/ISRCTN50586181.",2020,"Among participants still smoking at postintervention, the TG was significantly more ready to quit compared to the CG (TG: mean 7.71, SD 0.13; CG: mean 7.16, SD 0.13; P=.005).","['A sample of 120 participants was recruited in the city of Buenos Aires, Argentina (mean age 43.20 years, SD 9.50; 57/120, 47.5% female', 'Smoking Cessation']","['digital intervention Mindcotine (MindCotine Inc', 'Virtual Reality Smartphone-Based Intervention', 'virtual reality combined with mindfulness', 'self-assisted 21-day program based on virtual reality mindful exposure therapy (VR-MET) sessions, daily surveys, and online peer-to-peer support moderated by psychologists, or a control group (CG), which received the online version of the smoking cessation manual from the Argentine Ministry of Health', 'Mindcotine']","['self-reported abstinence at postintervention, with missing data assumed as still smoking', 'ready to quit', 'sustained abstinence at 90-day follow-up, adherence to the program, and readiness to quit']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1741275', 'cui_str': 'AIRE protein, human'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0033908', 'cui_str': 'Psychologist'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}]",120.0,0.0805419,"Among participants still smoking at postintervention, the TG was significantly more ready to quit compared to the CG (TG: mean 7.71, SD 0.13; CG: mean 7.16, SD 0.13; P=.005).","[{'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Goldenhersch', 'Affiliation': 'Laboratorio de Investigación en Neurociencia y Ciencias Sociales, Universidad de Flores, Ciudad Autónoma de Buenos Aires, Argentina.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Thrul', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Ungaretti', 'Affiliation': 'Facultad de Psicología, Universidad de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rosencovich', 'Affiliation': 'Escuela de Ingeniería Biomédica, Universidad Nacional de Córdoba, Córdoba, Argentina.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Waitman', 'Affiliation': 'Universidad Siglo XXI, Córdoba, Argentina.'}, {'ForeName': 'Marcelo Rodriguez', 'Initials': 'MR', 'LastName': 'Ceberio', 'Affiliation': 'Laboratorio de Investigación en Neurociencia y Ciencias Sociales, Universidad de Flores, Ciudad Autónoma de Buenos Aires, Argentina.'}]",Journal of medical Internet research,['10.2196/17571']
1736,32726531,Phase 1 Trial of a Therapeutic Anti-Yellow Fever Virus Human Antibody.,"BACKGROUND


Insufficient vaccine doses and the lack of therapeutic agents for yellow fever put global health at risk, should this virus emerge from sub-Saharan Africa and South America.
METHODS


In phase 1a of this clinical trial, we assessed the safety, side-effect profile, and pharmacokinetics of TY014, a fully human IgG1 anti-yellow fever virus monoclonal antibody. In a double-blind, phase 1b clinical trial, we assessed the efficacy of TY014, as compared with placebo, in abrogating viremia related to the administration of live yellow fever vaccine (YF17D-204; Stamaril). The primary safety outcomes were adverse events reported 1 hour after the infusion and throughout the trial. The primary efficacy outcome was the dose of TY014 at which 100% of the participants tested negative for viremia within 48 hours after infusion.
RESULTS


A total of 27 healthy participants were enrolled in phase 1a, and 10 participants in phase 1b. During phase 1a, TY014 dose escalation to a maximum of 20 mg per kilogram of body weight occurred in 22 participants. During phases 1a and 1b, adverse events within 1 hour after infusion occurred in 1 of 27 participants who received TY014 and in none of the 10 participants who received placebo. At least one adverse event occurred during the trial in 22 participants who received TY014 and in 8 who received placebo. The mean half-life of TY014 was approximately 12.8 days. At 48 hours after the infusion, none of the 5 participants who received the starting dose of TY014 of 2 mg per kilogram had detectable YF17D-204 viremia; these participants remained aviremic throughout the trial. Viremia was observed at 48 hours after the infusion in 2 of 5 participants who received placebo and at 72 hours in 2 more placebo recipients. Symptoms associated with yellow fever vaccine were less frequent in the TY014 group than in the placebo group.
CONCLUSIONS


This phase 1 trial of TY014 did not identify worrisome safety signals and suggested potential clinical benefit, which requires further assessment in a phase 2 trial. (Funded by Tysana; ClinicalTrials.gov number, NCT03776786.).",2020,At least one adverse event occurred during the trial in 22 participants who received TY014 and in 8 who received placebo.,"['27 healthy participants were enrolled in phase 1a, and 10 participants in phase 1b']","['Therapeutic Anti-Yellow Fever Virus Human Antibody', 'placebo']","['Viremia', 'negative for viremia', 'adverse event', 'adverse events', 'detectable YF17D-204 viremia']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0043396', 'cui_str': 'Yellow fever virus'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",22.0,0.484793,At least one adverse event occurred during the trial in 22 participants who received TY014 and in 8 who received placebo.,"[{'ForeName': 'Jenny G', 'Initials': 'JG', 'LastName': 'Low', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Justin H J', 'Initials': 'JHJ', 'LastName': 'Ng', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Eugenia Z', 'Initials': 'EZ', 'LastName': 'Ong', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Kalimuddin', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Wijaya', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Yvonne F Z', 'Initials': 'YFZ', 'LastName': 'Chan', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Dorothy H L', 'Initials': 'DHL', 'LastName': 'Ng', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Hwee-Cheng', 'Initials': 'HC', 'LastName': 'Tan', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Baglody', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Yok-Hian', 'Initials': 'YH', 'LastName': 'Chionh', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Debbie C P', 'Initials': 'DCP', 'LastName': 'Lee', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Yadunanda', 'Initials': 'Y', 'LastName': 'Budigi', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Ram', 'Initials': 'R', 'LastName': 'Sasisekharan', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}, {'ForeName': 'Eng-Eong', 'Initials': 'EE', 'LastName': 'Ooi', 'Affiliation': 'From the Duke-National University of Singapore Medical School (J.G.L., E.Z.O., H.-C.T., E.-E.O.), Singapore General Hospital (J.G.L., S.K., L.W., Y.F.Z.C., D.H.L.N.), Tysana (J.H.J.N., A.B., Y.-H.C., D.C.P.L., Y.B.), and the Singapore-MIT (Massachusetts Institute of Technology) Alliance for Research and Technology (R.S., E.-E.O.) - all in Singapore; and the Massachusetts Institute of Technology, Cambridge (R.S.).'}]",The New England journal of medicine,['10.1056/NEJMoa2000226']
1737,32728832,Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog ®  in Japanese Patients with Type 1 Diabetes: PRONTO-T1D Subpopulation Analysis.,"INTRODUCTION


We evaluated the efficacy and safety of ultra-rapid lispro (URLi) in comparison to lispro in a subgroup analysis of Japanese adults with type 1 diabetes mellitus from the phase 3 PRONTO-T1D trial.
METHODS


After an 8-week lead-in to optimize basal insulin treatment, patients were randomized to 52-week double-blind mealtime URLi or lispro, or 26-week open-label postmeal URLi. The primary endpoint was change in hemoglobin A1c (HbA1c) from baseline (week 0) to week 26 between mealtime URLi and lispro. The multiplicity adjusted objectives were 1- and 2-h postprandial glucose (PPG) excursions after a meal test between mealtime URLi and lispro, and change in HbA1c from baseline to week 26 between postmeal URLi and mealtime lispro.
RESULTS


This manuscript presents pre-specified exploratory analyses of 26-week data from Japanese patients randomized to double-blind URLi (n = 62) or lispro (n = 59), or open-label URLi (n = 46). Mean baseline HbA1c levels were 7.52% for mealtime URLi, 7.44% for lispro, and 7.51% for postmeal URLi at randomization. At week 26, the least squares mean (LSM) difference compared to lispro was 0.04% (95% confidence interval [CI] - 0.14 to 0.22) for mealtime URLi, and 0.16% (95% CI - 0.04 to 0.35) for postmeal URLi. In comparison to lispro, mealtime URLi resulted in statistically significantly lower 1- and 2-h PPG excursions during the mixed-meal tolerance test. LSM differences were - 40.5 mg/dL, 95% CI - 59.5 to 21.4 (- 2.25 mmol/L, 95% CI - 3.3 to - 1.2) for 1-h PPG excursions and - 51.7 mg/dL, 95% CI - 81.7 to - 21.8 (- 2.87 mmol/L, 95% CI - 4.5 to - 1.2) for 2-h PPG excursions at week 26. There were no significant treatment differences in rates of severe/overall hypoglycemia, or incidence of treatment-emergent adverse events.
CONCLUSIONS


Mealtime and postmeal URLi provide effective and comparable glycemic control in Japanese patients. Mealtime URLi demonstrated more effective PPG control compared to lispro.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03214367.",2020,"In comparison to lispro, mealtime URLi resulted in statistically significantly lower 1- and 2-h PPG excursions during the mixed-meal tolerance test.","['Japanese patients', 'Japanese adults with type\xa01 diabetes mellitus from the phase\xa03 PRONTO-T1D trial', 'Japanese patients randomized to', 'Japanese Patients with Type\xa01 Diabetes']","['double-blind mealtime URLi or lispro, or 26-week open-label postmeal URLi', 'ultra-rapid lispro (URLi', 'lispro (n\u2009=\u200959), or open-label URLi', 'double-blind URLi']","['change in hemoglobin A1c (HbA1c', '2-h postprandial glucose (PPG) excursions', 'rates of severe/overall hypoglycemia, or incidence of treatment-emergent adverse events', 'Mean baseline HbA1c levels', 'LSM differences', 'Ultra-Rapid Lispro Efficacy and Safety', '1- and 2-h PPG excursions']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C1260720', 'cui_str': 'Pronto'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}]",,0.14673,"In comparison to lispro, mealtime URLi resulted in statistically significantly lower 1- and 2-h PPG excursions during the mixed-meal tolerance test.","[{'ForeName': 'Junnosuke', 'Initials': 'J', 'LastName': 'Miura', 'Affiliation': ""Tokyo Women's Medical University School of Medicine, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Imori', 'Affiliation': 'Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K., 5-1-28, Isogami-dori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan. imori_makoto@lilly.com.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nishiyama', 'Affiliation': 'Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K., 5-1-28, Isogami-dori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Imaoka', 'Affiliation': 'Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K., 5-1-28, Isogami-dori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00892-0']
1738,32728833,Ultra-Rapid Lispro Efficacy and Safety Compared to Humalog® in Japanese Patients With Type 2 Diabetes: PRONTO-T2D Subpopulation Analysis.,"INTRODUCTION


The aim of this study was to evaluate the efficacy and safety of ultra-rapid lispro (URLi) versus lispro in a subgroup analysis of Japanese adults with type 2 diabetes mellitus (T2DM) from the phase 3 PRONTO-T2D trial.
METHODS


After an 8-week lead-in period during which patients transitioned to insulin lispro 3 times a day before main meals in association with basal insulin (glargine or degludec), the patients were randomized to 26 weeks of double-blind URLi or lispro injected immediately prior to meals. The primary endpoint was change in hemoglobin A1c (HbA1c) from baseline to week 26 between URLi and lispro. The multiplicity-adjusted objectives were 1- and 2-h postprandial glucose (PPG) excursions after a test meal and change in HbA1c from baseline to week 26 in the URLi and lispro groups.
RESULTS


Results were obtained from prespecified exploratory analyses of 26-week data in Japanese patients randomized to receive URLi (n = 47) or lispro (n = 46). Mean baseline HbA1c levels significantly improved during the lead-in period to a baseline value of 7.50% and 7.60% in patients subsequently randomized to the URLi and lispro treatment groups, respectively. At week 26, the least squares mean (LSM) difference in HbAc1 between the URLi and lispro groups was 0.13% (95% confidence interval [CI] - 0.12 to 0.39) (1.4 mmol/mol, 95% CI - 1.3 to 4.2). Although there were no significant differences in PPG excursions at any time-point, numerically smaller PPG excursions were consistently observed from 30 min to 3 h during the mixed-meal tolerance test in patients on URLi compared to those on lispro. LSM differences in PPG excursions at week 26 were - 10.5 mg/dL (95% CI - 32.7 to 11.7) (- 0.58 mmol/L, 95% CI - 1.82 to 0.65) at 1 h and - 14.9 mg/dL (95% CI - 40.3 to 10.5) (- 0.83 mmol/L, 95% CI - 2.24 to 0.58) at 2 h. There were no significant differences between treatments in rates of severe/overall hypoglycemia or incidence of treatment-emergent adverse events.
CONCLUSIONS


URLi administered as prandial insulin in combination with basal insulin provides effective glycemic control when administered immediately before a meal in Japanese patients with T2DM. URLi was well tolerated in this population.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT03214380.",2020,"Although there were no significant differences in PPG excursions at any time-point, numerically smaller PPG excursions were consistently observed from 30 min to 3 h during the mixed-meal tolerance test in patients on URLi compared to those on lispro.","['Japanese adults with type 2 diabetes mellitus (T2DM', 'Japanese Patients With Type 2 Diabetes', 'Japanese patients with T2DM']","['double-blind URLi or lispro injected immediately prior to meals', 'Humalog®', 'ultra-rapid lispro (URLi) versus lispro', 'lispro', 'URLi', 'insulin lispro 3 times a day before main meals in association with basal insulin (glargine or degludec']","['change in hemoglobin A1c (HbA1c', 'rates of severe/overall hypoglycemia or incidence of treatment-emergent adverse events', 'LSM differences in PPG excursions', 'PPG excursions', 'Mean baseline HbA1c levels', 'efficacy and safety', 'postprandial glucose (PPG) excursions', 'Ultra-Rapid Lispro Efficacy and Safety']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0528249', 'cui_str': 'Humalog'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0474680', 'cui_str': 'Hemoglobin A1c measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}]",,0.143219,"Although there were no significant differences in PPG excursions at any time-point, numerically smaller PPG excursions were consistently observed from 30 min to 3 h during the mixed-meal tolerance test in patients on URLi compared to those on lispro.","[{'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Jinnouchi Hospital, 6 Chome-2-3 Kuhonji, Chuo Ward, Kumamoto, 862-0976, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Imori', 'Affiliation': 'Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K, 5-1-28, Isogami-dori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan. imori_makoto@lilly.com.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nishiyama', 'Affiliation': 'Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K, 5-1-28, Isogami-dori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Imaoka', 'Affiliation': 'Medicines Development Unit Japan and Medical Affairs, Eli Lilly Japan K.K, 5-1-28, Isogami-dori, Chuo-ku, Kobe, Hyogo, 651-0086, Japan.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00890-2']
1739,32729586,Effects of intragastric tryptophan on acute changes in the plasma tryptophan/large neutral amino acids ratio and relationship with subsequent energy intake in lean and obese men.,"Circulating tryptophan/large neutral amino acids (tryptophan/LNAA) ratio, an indicator of brain serotonin levels, may be important in appetite regulation, together with gastrointestinal (gastric emptying, plasma cholecystokinin) mechanisms. We have compared effects of intragastric tryptophan ('Trp') on the plasma tryptophan/LNAA ratio in lean and obese men, and the associations of the tryptophan/LNAA ratio, gastric emptying and CCK concentrations with energy intake. Lean and obese male participants (n = 16 each) received 3 g Trp or volume-matched control intragastrically, 15 min before a mixed-nutrient drink (300 mL, 400 kcal) (t = 0 min) in randomised, double-blind fashion. Plasma amino acid (for calculation of the plasma tryptophan/LNAA ratio) and CCK concentrations were measured from t = -20-60 min. Gastric emptying was assessed from t = 0-60 min, and ad-libitum energy intake from a standardised buffet-style meal from t = 60-90 min. The increase in the plasma tryptophan/LNAA ratio was less in obese, than lean, participants (P < 0.05), and greater in lean participants who reduced their energy intake (by >0 kcal) after Trp compared with those who did not (by ≤0 kcal) (P < 0.05). Moreover, in participants who reduced their energy intake, the ratio was lower in obese, than in lean (P < 0.05). There was a trend for an inverse correlation between energy intake with the plasma tryptophan/LNAA ratio in lean (r = -0.4, P = 0.08), but not in obese, participants. There was no significant difference in gastric emptying or CCK between participants who reduced their energy intake and those who did not. In conclusion, the plasma tryptophan/LNAA ratio appears to be a determinant of the suppression of energy intake in response to tryptophan in normal-weight people, but not in those with obesity. The role of the plasma tryptophan/LNAA ratio to regulate energy intake, and potential changes in obesity, warrant evaluation in prospective studies.",2020,There was no significant difference in gastric emptying or CCK between participants who reduced their energy intake and those who did not.,"['Lean and obese male participants (n = 16 each) received', 'lean and obese men']","['intragastric tryptophan', ""intragastric tryptophan ('Trp"", '3 g Trp or volume-matched control intragastrically, 15 min before a mixed-nutrient drink']","['plasma tryptophan/LNAA ratio in lean', 'plasma tryptophan/LNAA ratio', 'Gastric emptying', 'tryptophan/LNAA ratio, gastric emptying and CCK concentrations with energy intake', 'gastric emptying or CCK', 'Plasma amino acid (for calculation of the plasma tryptophan/LNAA ratio) and CCK concentrations', 'energy intake']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0442113', 'cui_str': 'Intragastric'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}]",,0.103926,There was no significant difference in gastric emptying or CCK between participants who reduced their energy intake and those who did not.,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Hajishafiee', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, Australia. christine.feinle@adelaide.edu.au.'}, {'ForeName': 'Sina S', 'Initials': 'SS', 'LastName': 'Ullrich', 'Affiliation': ''}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Steinert', 'Affiliation': ''}, {'ForeName': 'Sally D', 'Initials': 'SD', 'LastName': 'Poppitt', 'Affiliation': ''}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Luscombe-Marsh', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Feinle-Bisset', 'Affiliation': ''}]",Food & function,['10.1039/d0fo00773k']
1740,32726528,Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants.,"BACKGROUND


Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection in infants, and a need exists for prevention of RSV in healthy infants. Nirsevimab is a monoclonal antibody with an extended half-life that is being developed to protect infants for an entire RSV season with a single intramuscular dose.
METHODS


In this trial conducted in both northern and southern hemispheres, we evaluated nirsevimab for the prevention of RSV-associated lower respiratory tract infection in healthy infants who had been born preterm (29 weeks 0 days to 34 weeks 6 days of gestation). We randomly assigned the infants in a 2:1 ratio to receive nirsevimab, at a dose of 50 mg in a single intramuscular injection, or placebo at the start of an RSV season. The primary end point was medically attended RSV-associated lower respiratory tract infection through 150 days after administration of the dose. The secondary efficacy end point was hospitalization for RSV-associated lower respiratory tract infection through 150 days after administration of the dose.
RESULTS


From November 2016 through November 2017, a total of 1453 infants were randomly assigned to receive nirsevimab (969 infants) or placebo (484 infants) at the start of the RSV season. The incidence of medically attended RSV-associated lower respiratory tract infection was 70.1% lower (95% confidence interval [CI], 52.3 to 81.2) with nirsevimab prophylaxis than with placebo (2.6% [25 infants] vs. 9.5% [46 infants]; P<0.001) and the incidence of hospitalization for RSV-associated lower respiratory tract infection was 78.4% lower (95% CI, 51.9 to 90.3) with nirsevimab than with placebo (0.8% [8 infants] vs. 4.1% [20 infants]; P<0.001). These differences were consistent throughout the 150-day period after the dose was administered and across geographic locations and RSV subtypes. Adverse events were similar in the two trial groups, with no notable hypersensitivity reactions.
CONCLUSIONS


A single injection of nirsevimab resulted in fewer medically attended RSV-associated lower respiratory tract infections and hospitalizations than placebo throughout the RSV season in healthy preterm infants. (Funded by AstraZeneca and Sanofi Pasteur; ClinicalTrials.gov number, NCT02878330.).",2020,A single injection of nirsevimab resulted in fewer medically attended RSV-associated lower respiratory tract infections and hospitalizations than placebo throughout the RSV season in healthy preterm infants.,"['healthy infants who had been born preterm (29 weeks 0 days to 34 weeks 6 days of gestation', 'Preterm Infants', 'northern and southern hemispheres', '969 infants) or', 'healthy preterm infants', 'From November 2016 through November 2017, a total of 1453 infants', 'healthy infants']","['placebo', 'nirsevimab']","['Adverse events', 'incidence of medically attended RSV-associated lower respiratory tract infection', 'medically attended RSV-associated lower respiratory tract infection', 'incidence of hospitalization for RSV-associated lower respiratory tract infection', 'hospitalization for RSV-associated lower respiratory tract infection']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",1453.0,0.503207,A single injection of nirsevimab resulted in fewer medically attended RSV-associated lower respiratory tract infections and hospitalizations than placebo throughout the RSV season in healthy preterm infants.,"[{'ForeName': 'M Pamela', 'Initials': 'MP', 'LastName': 'Griffin', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Takas', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Domachowske', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manzoni', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Eric A F', 'Initials': 'EAF', 'LastName': 'Simões', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Esser', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Anis A', 'Initials': 'AA', 'LastName': 'Khan', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Dubovsky', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Villafana', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'DeVincenzo', 'Affiliation': ""From AstraZeneca, Gaithersburg, MD (M.P.G., Y.Y., T.T., M.T.E., A.A.K., F.D., T.V.); SUNY Upstate Medical University, Syracuse, NY (J.B.D.); Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, and Department of Science and Technology/National Research Foundation South African Research Chair, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (S.A.M.); the Division of Pediatrics and Neonatology, Department of Maternal, Neonatal, and Infant Medicine, Nuovo Ospedale Degli Infermi, Biella, and Neonatology and NICU, Sant'Anna Hospital, AOU Città della Salute e della Scienza, Turin - both in Italy (P.M.); the University of Colorado School of Medicine, Aurora (E.A.F.S.); and the Children's Foundation Research Institute at Le Bonheur Children's Hospital, Memphis, TN (J.P.D.V.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1913556']
1741,32727613,"Pre-exposure prophylaxis with hydroxychloroquine for high-risk healthcare workers during the COVID-19 pandemic: A structured summary of a study protocol for a multicentre, double-blind randomized controlled trial.","OBJECTIVES


The aim of this study is to assess the efficacy of the use of pre-exposure prophylaxis (PrEP) with hydroxychloroquine against placebo in healthcare workers with high risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in reducing their risk of coronavirus disease 2019 (COVID-19) disease during an epidemic period. As secondary objectives, we would like to: i) assess the efficacy of the use of PrEP with hydroxychloroquine against placebo in healthcare workers with high risk of SARS-CoV-2 infection in reducing their risk of exposure to SARS-CoV-2 (defined by seroconversion) during an epidemic period, ii) evaluate the safety of PrEP with hydroxychloroquine in adults, iii) describe the incidence of SARS-CoV-2 infection among healthcare workers at high risk of SARS-CoV-2 infection, iv) identify clinical, analytical and microbiological predictors of COVID-19 among healthcare workers at high risk of SARS-CoV-2 infection, v) set up a repository of serum samples obtained from healthcare workers at high risk of SARS-CoV-2 infection for future research on blood markers to predict SARS-CoV-2 infection.
TRIAL DESIGN


Multicentre double-blind parallel design (ratio 1:1) randomized controlled clinical trial.
PARTICIPANTS


Approximately 440 healthcare workers of four Spanish hospitals (Hospital Clínic of Barcelona, Hospital de la Santa Creu i Sant Pau of Barcelona, Hospital Plató of Barcelona, Hospital General de Granollers, Barcelona) will be recruited. Participants are considered to be at high-risk of SARS-CoV-2 infection due to their frequent contact with suspected and confirmed cases of COVID-19. For eligibility, healthcare workers with 18 years old or older working at least 3 days a week in a hospital with both negative SARS-CoV-2 polymerase chain reaction (PCR) assays and serological COVID-19 rapid diagnostic tests (RDT) are invited to participate. Participants with any of the following conditions are excluded: pregnancy, breastfeeding, ongoing antiviral, antiretroviral or corticosteroids treatment, chloroquine or hydroxychloroquine uptake the last month or any contraindication to hydroxychloroquine treatment.
INTERVENTION AND COMPARATOR


Eligible participants will be allocated to one of the two study groups: Intervention group (PrEP): participants will receive the standard of care and will take 400mg of hydroxychloroquine (2 tablets of 200 mg per Dolquine® tablet) daily the first four consecutive days, followed by 400 mg weekly for a period of 6 months.
CONTROL GROUP


participants will receive placebo tablets with identical physical appearance to hydroxychloroquine 200 mg (Dolquine®) tablets following the same treatment schedule of the intervention group. Both groups will be encouraged to use the personal protection equipment (PPE) for COVID-19 prevention according to current hospital guidelines.
MAIN OUTCOMES


The primary endpoint will be the number of confirmed cases of a COVID-19 (defined by a positive PCR for SARS-CoV-2 or symptoms compatible with COVID-19 with seroconversion) in the PrEP group compared to the placebo group at any time during the 6 months of the follow-up in healthcare workers with negative SARS-CoV-2 PCR and serology at day 0. As secondary endpoints, we will obtain: i) the SARS-CoV-2 seroconversion in the PrEP group compared to placebo during the 6 months of follow-up in healthcare workers with negative serology at day 0; ii) the occurrence of any adverse event related with hydroxychloroquine treatment; iii) the incidence of SARS-CoV-2 infection and COVID-19 among healthcare workers in the non-PrEP group, among the total of healthcare workers included in the non-PrEP group during the study period; iv) the risk ratio for the different clinical, analytical and microbiological conditions to develop COVID-19; v) a repository of serum samples obtained from healthcare workers confirmed COVID-19 cases for future research on blood markers to predict SARS-CoV-2 infection.
RANDOMISATION


Participants meeting all eligibility requirements will be allocated to one of the two study arms (PrEP with hydroxychloroquine or non-PrEP control group) in a 1:1 ratio using simple randomisation with computer generated random numbers.
BLINDING (MASKING)


Participants, doctors and nurses caring for participants, and investigators assessing the outcomes will be blinded to group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


Each intervention group will have 220 participants, giving a total of 440 participants.
TRIAL STATUS


The current protocol version is 1.5, 2 nd  of June 2020. Two hundred and seventy-fiveparticipants were recruited and completed first month follow-up until date. The estimated sample size could not be reached yet due to the declining national epidemic curve. Thus, 275 is the total number of participants included until date. The study has been suspended (26 th  of June) until new epidemic curve occurs.
TRIAL REGISTRATION


This trial was registered on April 2 nd  2020 at clinicaltrials.gov with the number NCT04331834.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Both groups will be encouraged to use the personal protection equipment (PPE) for COVID-19 prevention according to current hospital guidelines.
","['healthcare workers with high risk of SARS-CoV-2 infection', '220 participants, giving a total of 440 participants', 'For eligibility, healthcare workers with 18 years old or older working at least 3 days a week in a hospital with both negative SARS-CoV-2 polymerase chain reaction (PCR) assays and serological COVID-19 rapid diagnostic tests (RDT) are invited to participate', 'Participants with any of the following conditions are excluded: pregnancy, breastfeeding, ongoing antiviral, antiretroviral or corticosteroids treatment, chloroquine or hydroxychloroquine uptake the last month or any contraindication to hydroxychloroquine treatment', 'Two hundred and seventy-fiveparticipants', 'high-risk healthcare workers during the COVID-19 pandemic', 'Approximately 440 healthcare workers of four Spanish hospitals (Hospital Clínic of Barcelona, Hospital de la', 'healthcare workers with high risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2']","['pre-exposure prophylaxis (PrEP', 'Intervention group (PrEP): participants will receive the standard of care and will take 400mg of hydroxychloroquine', 'hydroxychloroquine against placebo', 'hydroxychloroquine 200 mg (Dolquine®) tablets', 'Santa Creu', 'hydroxychloroquine', 'personal protection equipment (PPE', 'hydroxychloroquine or non-PrEP control group', 'placebo']","['number of confirmed cases of a COVID-19 (defined by a positive PCR for SARS-CoV-2 or symptoms compatible with COVID-19 with seroconversion', 'SARS-CoV-2 seroconversion']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0205473', 'cui_str': 'Serologic'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",440.0,0.362036,"Both groups will be encouraged to use the personal protection equipment (PPE) for COVID-19 prevention according to current hospital guidelines.
","[{'ForeName': 'Berta', 'Initials': 'B', 'LastName': 'Grau-Pujol', 'Affiliation': 'Barcelona Institute for Global Health (ISGlobal), Hospital Clínic - Universitat de Barcelona, Barcelona, Spain. berta.grau@isglobal.org.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Camprubí', 'Affiliation': 'Barcelona Institute for Global Health (ISGlobal), Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Marti-Soler', 'Affiliation': 'Barcelona Institute for Global Health (ISGlobal), Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fernández-Pardos', 'Affiliation': 'Barcelona Institute for Global Health (ISGlobal), Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Guinovart', 'Affiliation': 'Barcelona Institute for Global Health (ISGlobal), Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Muñoz', 'Affiliation': 'Barcelona Institute for Global Health (ISGlobal), Hospital Clínic - Universitat de Barcelona, Barcelona, Spain.'}]",Trials,['10.1186/s13063-020-04621-7']
1742,32727748,Is Low Inferior Mesenteric Artery Ligation Worthwhile to Prevent Urinary and Sexual Dysfunction After Total Mesorectal Excision for Rectal Cancer?,"BACKGROUND/AIM


We studied the role of high or low inferior mesenteric artery (IMA) tie on defecatory, sexual and urinary dysfunctions in patients who underwent laparoscopic TME for early rectal cancer.
PATIENTS AND METHODS


Forty-six consecutive patients undergoing curative laparoscopic resection for pT2N0M0, rectal adenocarcinoma from February 2013 to March 2019 were enrolled into this prospective randomized open label parallel trial to have a laparoscopic TME with a high (Group 1) or low IMA ligation (Group 2). Demographic data and information on symptoms and comorbidity, intra- and post-operative outcomes and defecatory, sexual and urinary functions before and after surgery according to the validated International quality of life questionnaires.
RESULTS


A significant difference in postoperative total score of FIQL scale, Jorge-Wexner incontinence score and Agachan-Wexner constipation score were observed between the high and low tie groups at 1, 6, and 12 months after surgery. ICIQ-UI short form, FSFI, and IIEF demonstrated at 1, 6 and 12 months, the scores were significantly higher for patients of Group 1 as compared to those of Group 2.
CONCLUSION


A low IMA ligation permits a better fecal continence, less abdominal pain, and less genito-urinary and sexual dysfunctions in patients submitted to TME for rectal cancer.",2020,"A significant difference in postoperative total score of FIQL scale, Jorge-Wexner incontinence score and Agachan-Wexner constipation score were observed between the high and low tie groups at 1, 6, and 12 months after surgery.","['for pT2N0M0, rectal adenocarcinoma from February 2013 to March 2019', 'patients who underwent', 'Forty-six consecutive patients undergoing', 'for early rectal cancer', 'patients submitted to TME for rectal cancer']","['laparoscopic TME with a high (Group 1) or low IMA ligation', 'laparoscopic TME', 'Total Mesorectal Excision', 'high or low inferior mesenteric artery (IMA) tie', 'curative laparoscopic resection']","['fecal continence, less abdominal pain', 'Urinary and Sexual Dysfunction', 'genito-urinary and sexual dysfunctions', 'postoperative total score of FIQL scale, Jorge-Wexner incontinence score and Agachan-Wexner constipation score', 'ICIQ-UI short form, FSFI, and IIEF', 'Demographic data and information on symptoms and comorbidity, intra- and post-operative outcomes and defecatory, sexual and urinary functions']","[{'cui': 'C0149978', 'cui_str': 'Adenocarcinoma of rectum'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1273428', 'cui_str': 'Total mesorectal excision'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162860', 'cui_str': 'Structure of inferior mesenteric artery'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0453920', 'cui_str': 'Tie'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0429956', 'cui_str': 'Bowels: fully continent'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}]",46.0,0.0291762,"A significant difference in postoperative total score of FIQL scale, Jorge-Wexner incontinence score and Agachan-Wexner constipation score were observed between the high and low tie groups at 1, 6, and 12 months after surgery.","[{'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Fiori', 'Affiliation': 'Department of Surgery ""Pietro Valdoni"", ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Crocetti', 'Affiliation': 'Department of Surgery ""Pietro Valdoni"", ""Sapienza"" University of Rome, Rome, Italy danielecrocetti@hotmail.it.'}, {'ForeName': 'Antonietta', 'Initials': 'A', 'LastName': 'Lamazza', 'Affiliation': 'Department of Surgery ""Pietro Valdoni"", ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'DE Felice', 'Affiliation': 'Department of Radiology, Radiotherapy, Oncology and Pathology, ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Antonio V', 'Initials': 'AV', 'LastName': 'Sterpetti', 'Affiliation': 'Department of Surgery ""Pietro Valdoni"", ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Irace', 'Affiliation': 'Department of Surgery ""Paride Stefanini"", ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mingoli', 'Affiliation': 'Department of Surgery ""Pietro Valdoni"", ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Sapienza', 'Affiliation': 'Department of Surgery ""Pietro Valdoni"", ""Sapienza"" University of Rome, Rome, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'DE Toma', 'Affiliation': 'Department of Surgery ""Pietro Valdoni"", ""Sapienza"" University of Rome, Rome, Italy.'}]",Anticancer research,['10.21873/anticanres.14423']
1743,32732787,Impact of a Follow-up Telephone Call Program on 30-Day Readmissions (FUTR-30): A Pragmatic Randomized Controlled Real-world Effectiveness Trial.,"BACKGROUND


Telephone call programs are a common intervention used to improve patients' transition to outpatient care after hospital discharge.
OBJECTIVE


To examine the impact of a follow-up telephone call program as a readmission reduction initiative.
RESEARCH DESIGN


Pragmatic randomized controlled real-world effectiveness trial.
SUBJECTS


We enrolled and randomized all patients discharged home from a hospital general medicine service to a follow-up telephone call program or usual care discharge. Patients discharged against medical advice were excluded. The intervention was a hospital program, delivering a semistructured follow-up telephone call from a nurse within 3-7 days of discharge, designed to assess understanding and provide education, and assistance to support discharge plan implementation.
MEASURES


Our primary endpoint was hospital inpatient readmission within 30 days identified by the electronic health record. Secondary endpoints included observation readmission, emergency department revisit, and mortality within 30 days, and patient experience ratings.
RESULTS


All 3054 patients discharged home were enrolled and randomized to the telephone call program (n=1534) or usual care discharge (n=1520). Using a prespecified intention-to-treat analysis, we found no evidence supporting differences in 30-day inpatient readmissions [14.9% vs. 15.3%; difference -0.4 (95% confidence interval, 95% CI), -2.9 to 2.1; P=0.76], observation readmissions [3.8% vs. 3.6%; difference 0.2 (95% CI, -1.1 to 1.6); P=0.74], emergency department revisits [6.1% vs. 5.4%; difference 0.7 (95% CI, -1.0 to 2.3); P=0.43], or mortality [4.4% vs. 4.9%; difference -0.5 (95% CI, -2.0 to 1.0); P=0.51] between telephone call and usual care groups.
CONCLUSIONS


We found no evidence of an impact on 30-day readmissions or mortality due to the postdischarge telephone call program.",2020,We found no evidence of an impact on 30-day readmissions or mortality due to the postdischarge telephone call program.,"['Patients discharged against medical advice were excluded', ""patients' transition to outpatient care after hospital discharge"", 'All 3054 patients discharged home were enrolled and randomized to the', 'We enrolled and randomized all patients discharged home from a hospital general medicine service to a follow-up telephone call program or usual care discharge']","['telephone call program (n=1534) or usual care discharge', 'Follow-up Telephone Call Program']","['30-day readmissions or mortality', 'observation readmission, emergency department revisit, and mortality within 30 days, and patient experience ratings', 'emergency department revisits', 'hospital inpatient readmission', 'mortality', '30-day inpatient readmissions', 'observation readmissions', '30-Day Readmissions (FUTR-30']","[{'cui': 'C1304701', 'cui_str': 'Patient self-discharge against medical advice'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0086343', 'cui_str': 'General medicine'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0239966', 'cui_str': 'Hospital patient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]",3054.0,0.401488,We found no evidence of an impact on 30-day readmissions or mortality due to the postdischarge telephone call program.,"[{'ForeName': 'Maame Yaa A B', 'Initials': 'MYAB', 'LastName': 'Yiadom', 'Affiliation': 'Departments of Emergency Medicine.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Domenico', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Hasselblad', 'Affiliation': 'Medicine, Vanderbilt University.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kripalani', 'Affiliation': 'Medicine, Vanderbilt University.'}, {'ForeName': 'Neesha', 'Initials': 'N', 'LastName': 'Choma', 'Affiliation': 'Medicine, Vanderbilt University.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tucker-Marlow', 'Affiliation': 'Medicine, Vanderbilt University.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Gatto', 'Affiliation': 'Vanderbilt Institute for Clinical and Translational Research.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Monisha C', 'Initials': 'MC', 'LastName': 'Bhatia', 'Affiliation': 'School of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Johnston', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'Medicine, Vanderbilt University.'}, {'ForeName': 'Frank E', 'Initials': 'FE', 'LastName': 'Harrell', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Tina V', 'Initials': 'TV', 'LastName': 'Hartert', 'Affiliation': 'Vanderbilt Institute for Clinical and Translational Research.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lindsell', 'Affiliation': 'Departments of Emergency Medicine.'}, {'ForeName': 'Gordon R', 'Initials': 'GR', 'LastName': 'Bernard', 'Affiliation': 'Medicine, Vanderbilt University.'}]",Medical care,['10.1097/MLR.0000000000001353']
1744,32734691,"Genetic variation in lean body mass, changes of appetite and weight loss in response to diet interventions: The POUNDS Lost trial.","AIM


To investigate whether the genetic risk score (GRS) for lean body mass (LBM) modified the effects of weight-loss diets on changes in appetite and adiposity among overweight and obese individuals.
PARTICIPANTS AND METHODS


In the 2-year Preventing Overweight Using Novel Dietary Strategies (POUNDS Lost) trial, we included 692 adults who were randomly assigned to one of four diets varying in macronutrient intake. A GRS was calculated using five single nucleotide polymorphisms associated with LBM.
RESULTS


The LBM-GRS was not associated with the baseline LBM measured by dual-energy x-ray absorptiometry in a subgroup (50%) of the study population. We found that the LBM-GRS had significantly different associations with changes in appetite from baseline to 6 months according to low- or high-fat diet group (P-interaction < 0.001, 0.021, 0.005 and 0.024 for total appetite score, hunger, fullness and prospective consumption, respectively). Lower LBM-GRS (indicating a greater genetic predisposition to LBM) was associated with greater decreases in the total appetite score (P < 0.001), hunger (P = 0.01), fullness (P = 0.001) and prospective consumption (P = 0.019) in participants in the low-fat diet group, whereas no significant associations with these appetite measures were observed in the high-fat diet group. In addition, lower LBM-GRS was associated with greater reduction in body weight (P = 0.003) and waist circumference (P = 0.011) among participants in the low-fat diet group, while no associations were observed in the high-fat diet group. The interactions attenuated, along with weight regain, from 6 months to 2 years.
CONCLUSIONS


Our findings suggest that genetic variation in LBM may be differentially associated with appetite changes, and may subsequently be related to changes in body weight and waist circumference, according to dietary fat intake.",2020,The LBM-GRS was not associated with the baseline LBM measured by dual-energy x-ray absorptiometry in a subgroup (50%) of the study population.,"['overweight and obese individuals', '692 adults who were randomly assigned to 1 of 4']","['weight-loss diets', 'LBM-GRS', 'diets varying in macronutrient intake']","['appetite and adiposity', 'hunger', 'appetite measures', 'waist circumference', 'fullness', 'body weight', 'total appetite score', 'appetite', 'total appetite score, hunger, fullness, and prospective consumption, respectively', 'genetic risk score (GRS']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",692.0,0.0282244,The LBM-GRS was not associated with the baseline LBM measured by dual-energy x-ray absorptiometry in a subgroup (50%) of the study population.,"[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Yoriko', 'Initials': 'Y', 'LastName': 'Heianza', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Champagne', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Donald A', 'Initials': 'DA', 'LastName': 'Williamson', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Qi', 'Affiliation': 'Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14155']
1745,32735029,"Metoclopramide, Dexamethasone, or Palonosetron for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting After Moderately Emetogenic Chemotherapy (MEDEA): A Randomized, Phase III, Noninferiority Trial.","BACKGROUND


For the prevention of chemotherapy-induced nausea and vomiting (CINV) during the delayed phase (24-120 hours) after moderately emetogenic chemotherapy (MEC), the use of 3-day dexamethasone (DEX) is often recommended. This study compared the efficacy and safety of two DEX-sparing regimens with 3-day DEX, focusing on delayed nausea.
PATIENTS AND METHODS


This open-label, randomized, phase III study was designed to demonstrate noninferiority of two DEX-sparing regimens: ondansetron + DEX on day 1 + metoclopramide on days 2-3 (MCP arm), and palonosetron + DEX on day 1 (PAL arm) versus ondansetron on day 1 + DEX on days 1-3 (DEX arm) in chemotherapy-naïve patients receiving MEC. Primary efficacy endpoint was total control (TC; no emetic episodes, no use of rescue medication, no nausea) in the delayed phase. Noninferiority was defined as a lower 95% CI greater than the noninferiority margin set at -20%. Secondary endpoints included no vomiting, no rescue medication, no (significant) nausea, impact of CINV on quality of life, and antiemetics-associated side effects.
RESULTS


Treatment arms were comparable for 189 patients analyzed: predominantly male (55.7%), median age 65.0 years, colorectal cancer (85.7%), and oxaliplatin-based chemotherapy (81.5%). MCP demonstrated noninferiority to DEX for delayed TC (MCP 56.1% vs. DEX 50.0%; 95% CI, -11.3%, 23.5%). PAL also demonstrated noninferiority to DEX (PAL 55.6% vs. DEX 50.0%; 95% CI, -12.0%, 23.2%). There were no statistically significant differences for all secondary endpoints between treatment arms.
CONCLUSION


This study showed that DEX-sparing regimens are noninferior to multiple-day DEX in terms of delayed TC rate in patients undergoing MEC. ClinicalTrials.gov identifier. NCT02135510.
IMPLICATIONS FOR PRACTICE


Chemotherapy-induced nausea and vomiting (CINV) in the delayed phase (24-120 hours after chemotherapy) remains one of the most troublesome adverse effects associated with cancer treatment. In particular, delayed nausea is often poorly controlled. The role of dexamethasone (DEX) in the prevention of delayed nausea after moderately emetogenic chemotherapy (MEC) is controversial. This study is the first to include nausea assessment as a part of the primary study outcome to better gauge the effectiveness of CINV control and patients' experience. Results show that a DEX-sparing strategy does not result in any significant loss of overall antiemetic control: DEX-sparing strategies incorporating palonosetron or multiple-day metoclopramide are safe and at least as effective as standard treatment with a 3-day DEX regimen with ondansetron in controlling delayed CINV-and nausea in particular-following MEC.",2020,"MCP demonstrated noninferiority to DEX for delayed TC [MCP 56.1% versus DEX 50.0%, 95% CI (-11.3%, 23.5%)].","['189 patients analyzed: predominantly male (55.7%); median age 65.0\u2009years; colorectal cancer (85.7', 'patients undergoing MEC']","['DEX-sparing regimens: ondansetron + DEX', 'Emetogenic Chemotherapy (MEDEA', 'DEX', 'DEX-sparing regimens with 3-day DEX', 'chemotherapy-naïve patients receiving MEC', 'metoclopramide', 'palonosetron + DEX', 'emetogenic chemotherapy (MEC', 'oxaliplatin-based chemotherapy', 'dexamethasone (DEX', 'Metoclopramide, Dexamethasone or Palonosetron', 'ondansetron']","['delayed CINV - and nausea', 'delayed nausea', 'nausea and vomiting (CINV', 'Nausea and Vomiting', 'efficacy and safety', 'delayed TC rate', 'total control (TC; no emetic episodes, no use of rescue medication, no nausea', 'no vomiting, no rescue medication, no (significant) nausea, impact of CINV on quality of life, antiemetics-associated side-effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0220578', 'cui_str': 'palonosetron'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0401160', 'cui_str': 'Chemotherapy-induced nausea and vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0423584', 'cui_str': 'No nausea'}, {'cui': 'C0375548', 'cui_str': 'No vomiting'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0745552,"MCP demonstrated noninferiority to DEX for delayed TC [MCP 56.1% versus DEX 50.0%, 95% CI (-11.3%, 23.5%)].","[{'ForeName': 'Maurice J D L', 'Initials': 'MJDL', 'LastName': 'van der Vorst', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Elisa C', 'Initials': 'EC', 'LastName': 'Toffoli', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marlien', 'Initials': 'M', 'LastName': 'Beusink', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Myra E', 'Initials': 'ME', 'LastName': 'van Linde', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'van Voorthuizen', 'Affiliation': 'Department of Internal Medicine, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Brouwer', 'Affiliation': 'Department of Internal Medicine, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'Annette A', 'Initials': 'AA', 'LastName': 'van Zweeden', 'Affiliation': 'Amstelland Hospital, Amstelveen, The Netherlands.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Vrijaldenhoven', 'Affiliation': 'Department of Internal Medicine, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands.'}, {'ForeName': 'Johan C', 'Initials': 'JC', 'LastName': 'Berends', 'Affiliation': 'Department of Internal Medicine, Noordwest Ziekenhuisgroep, Den Helder, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Berkhof', 'Affiliation': 'Department of Epidemiology and Biostatistics, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk M W', 'Initials': 'HMW', 'LastName': 'Verheul', 'Affiliation': 'Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",The oncologist,['10.1634/theoncologist.2020-0305']
1746,32730719,Robotic approach to the reduction of dental anxiety in children.,"OBJECTIVE


We introduced a humanoid robot for the use of techno-psychological distraction techniques in children aged 4-10 to reduce their anxiety and improve their behaviour during dental treatment.
MATERIALS AND METHODS


Two hundred children (98 boys, 102 girls; mean age: 6.5 ± 1.66 years) appointed for first time for dental caries were included and randomly divided into two groups [ N  = 100 for each group; RG: Robot Group (accompanied by the robot), CG: Control Group (without robot accompaniment)]. Half of the children were treated under local anaesthesia (infiltration anaesthesia) ( n  = 50 within each group) and half of the children were treated without any local anaesthesia ( n  = 50 within each group) within each group. The success rate of the new robotic distraction technique was evaluated by using Parental Corah Dental Anxiety Scale, Facial Image Scale (FIS), physiological pulse rate and Frankl Behaviour Rating Scale (FBRS).
RESULT


Pulse rates, which measured during treatment and after treatment, were statistically higher in CG than in RG ( p  < .05). After dental treatment, the FIS score was significantly higher in CG than RG ( p  < .05). 88.3% of the children in RG stated that they wanted the robot to be with them at the next treatment session.
CONCLUSIONS


Robotic technology can successfully help in coping with dental anxiety and stress, and helps children to behave better in dental office.",2020,"After dental treatment, the FIS score was significantly higher in CG than RG ( p  < .05).","['Two hundred children (98 boys, 102 girls; mean age: 6.5\u2009±\u20091.66\u2009years) appointed for first time for dental caries', 'children aged 4-10', 'children']","['Robotic approach', 'local anaesthesia', 'humanoid robot', 'Robotic technology', 'RG: Robot Group (accompanied by the robot), CG: Control Group (without robot accompaniment', 'local anaesthesia (infiltration anaesthesia']","['success rate of the new robotic distraction technique', 'Parental Corah Dental Anxiety Scale, Facial Image Scale (FIS), physiological pulse rate and Frankl Behaviour Rating Scale (FBRS', 'dental anxiety', 'FIS score']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C4517510', 'cui_str': '1.66'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234945', 'cui_str': 'Infiltration anaesthesia'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0475483', 'cui_str': 'Behavior rating scale'}, {'cui': 'C3489630', 'cui_str': 'Isolated Familial Somatotropinoma'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",200.0,0.0252787,"After dental treatment, the FIS score was significantly higher in CG than RG ( p  < .05).","[{'ForeName': 'Yelda', 'Initials': 'Y', 'LastName': 'Kasimoglu', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Kocaaydin', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Karsli', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Esen', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Irmak', 'Initials': 'I', 'LastName': 'Bektas', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Gökhan', 'Initials': 'G', 'LastName': 'Ince', 'Affiliation': 'Department of Computer Engineering, Istanbul Technical University, Istanbul, Turkey.'}, {'ForeName': 'Elif Bahar', 'Initials': 'EB', 'LastName': 'Tuna', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Istanbul University, Istanbul, Turkey.'}]",Acta odontologica Scandinavica,['10.1080/00016357.2020.1800084']
1747,32730920,The role of endogenous GIP and GLP-1 in postprandial bone homeostasis.,"The incretin hormones glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) are well known for their insulinotropic effects and they are thought to affect bone homeostasis as mediators in the so-called entero-osseous axis. We examined the contributions of endogenous GIP and GLP-1, respectively, to postprandial bone homeostasis, in healthy subjects in two randomized and double-blind crossover studies. We included healthy men who received either four oral glucose tolerance tests (OGTTs) (n = 18, median age 27 (range 20-70), BMI 27.2 (22.4-37.0) kg/m 2 ) or liquid mixed meal tests (MMTs) (n = 12, age 23 (19-65), BMI 23.7 (20.3-25.5) kg/m 2 ) with infusions of 1) the GIP receptor antagonist GIP(3-30)NH 2 , 2) the GLP-1 receptor antagonist exendin(9-39)NH 2 , 3) both GIP(3-30)NH 2  and exendin(9-39)NH 2 , or 4) placebo infusions (saline) on four separate visits. Bone resorption was evaluated from levels of circulating carboxy-terminal collagen crosslinks (CTX) and bone formation from levels of procollagen type 1 amino-terminal propeptide (P1NP). During placebo infusions, baseline-subtracted area under the curve values for CTX were -39 ± 5.0 (OGTT) and -57 ± 4.3 ng/ml × min (MMT). When GIP(3-30)NH 2  was administered, CTX suppression was significantly diminished compared to placebo (-30 ± 4.8 (OGTT) and -45 ± 4.6 ng/ml × min (MMT), P = 0.0104 and P = 0.0288, respectively, compared to placebo. During exendin(9-39)NH 2  infusion, CTX suppression after OGTT/MMT was similar to placebo (P = 0.28 (OGTT) and P = 0.93 (MMT)). The relative contribution of endogenous GIP to postprandial suppression of bone resorption during both OGTT and MMT was similar and reached 22-25%. There were no differences in P1NP concentrations between interventions. In conclusion, endogenous GIP contributes by up to 25% to postprandial suppression of bone resorption in humans whereas an effect of endogenous GLP-1 could not be demonstrated.",2020,There were no differences in P1NP concentrations between interventions.,"['healthy subjects', 'healthy men who received either four oral glucose tolerance tests (OGTTs) (n = 18, median age 27 (range 20-70), BMI 27.2 (22.4-37.0) kg/m 2 ) or']","['liquid mixed meal tests (MMTs', 'placebo infusions (saline', 'placebo']","['bone resorption', 'CTX suppression', 'P1NP concentrations', 'Bone resorption']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C5191357', 'cui_str': '27.2'}]","[{'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0046370', 'cui_str': '2-methylcyclopentadienyl manganese tricarbonyl'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.20213,There were no differences in P1NP concentrations between interventions.,"[{'ForeName': 'Mads M', 'Initials': 'MM', 'LastName': 'Helsted', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Lærke S', 'Initials': 'LS', 'LastName': 'Gasbjerg', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Amalie R', 'Initials': 'AR', 'LastName': 'Lanng', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Natasha C', 'Initials': 'NC', 'LastName': 'Bergmann', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Signe', 'Initials': 'S', 'LastName': 'Stensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel B', 'Initials': 'MB', 'LastName': 'Christensen', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Pharmacology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Mette M', 'Initials': 'MM', 'LastName': 'Rosenkilde', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Filip K', 'Initials': 'FK', 'LastName': 'Knop', 'Affiliation': 'Center for Clinical Metabolic Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark. Electronic address: filipknop@dadlnet.dk.'}]",Bone,['10.1016/j.bone.2020.115553']
1748,32730930,A novel autologous bone graft substitute comprised of rhBMP6 blood coagulum as carrier tested in a randomized and controlled Phase I trial in patients with distal radial fractures.,"Bone morphogenetic proteins (BMPs) are known to induce new bone formation in vivo but treating trabecular bone defects with a BMP based therapeutic remains controversial. Here, we evaluated the safety and efficacy of a novel Autologous Bone Graft Substitute (ABGS) comprised of recombinant human BMP6 (rhBMP6) dispersed within an autologous blood coagulum (ABC) as a physiological natural carrier in patients with a closed distal radial fracture (DRF). We enrolled 32 patients in a randomized, standard of care (SoC) and placebo (PBO) controlled, double-blinded Phase I First in Human (FiH) clinical trial. ABGS was prepared from peripheral blood as 250 μg rhBMP6/mL ABC or PBO (1 mL ABC containing excipients only) and was administered dorsally via a syringe injection into the fracture site following closed fracture fixation with 3 Kirschner wires. Patients carried an immobilization for 5 weeks and were followed-up for 0 to 26 weeks by clinical examination, safety, serial radiographic analyses and CT. During the 13 weeks follow-up and at 26 weeks post study there were no serious adverse reactions recorded. The results showed that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 32 patients at 13- and 26-weeks following treatment. Pharmacokinetic analyses of plasma from patients treated with ABGS showed no detectable rhBMP6 at any time point within the first 24 h following administration. The CT image and radiographic analyses score from patients treated with AGBS showed significantly accelerated bone healing as compared to PBO and SoC at 5 and 9 weeks (with high effect sizes and P = 0.027), while at week 13 all patients had similar healing outcomes. In conclusion, we show that intraosseous administration of ABGS (250 μg rhBMP6/mL ABC) into the distal radial fracture site demonstrated a good tolerability with no serious adverse reactions as well as early accelerated trabecular bone healing as compared to control PBO and SoC patients.",2020,"The CT image and radiographic analyses score from patients treated with AGBS showed significantly accelerated bone healing as compared to PBO and SoC at 5 and 9 weeks (with high effect sizes and P=0.027), while at week 13 all patients had similar healing outcomes.","['patients with distal radial fractures', 'patients with a closed distal radial fracture (DRF']","['ABGS', 'novel Autologous Bone Graft Substitute (ABGS', 'standard of care (SoC) and placebo (PBO) controlled, double-blinded Phase', 'novel autologous bone graft substitute', 'Bone morphogenetic proteins (BMPs', 'recombinant human BMP6 (rhBMP6']","['accelerated bone healing', 'safety and efficacy', 'CT image and radiographic analyses score', 'detectable anti-rhBMP6 antibodies']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C0587267', 'cui_str': 'Closed'}]","[{'cui': 'C1699650', 'cui_str': 'Autologous bone graft'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0053932', 'cui_str': 'Bone morphogenetic proteins'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1612225', 'cui_str': 'BMP6 protein, human'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1612225', 'cui_str': 'BMP6 protein, human'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",32.0,0.0547507,"The CT image and radiographic analyses score from patients treated with AGBS showed significantly accelerated bone healing as compared to PBO and SoC at 5 and 9 weeks (with high effect sizes and P=0.027), while at week 13 all patients had similar healing outcomes.","[{'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Durdevic', 'Affiliation': 'Clinical Hospital Center ""Sisters of Mercy"", Clinic of Traumatology, Draskoviceva 19, 10000 Zagreb, Croatia.'}, {'ForeName': 'Tomislav', 'Initials': 'T', 'LastName': 'Vlahovic', 'Affiliation': 'Clinical Hospital Center ""Sisters of Mercy"", Clinic of Traumatology, Draskoviceva 19, 10000 Zagreb, Croatia.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Pehar', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000 Zagreb, Croatia.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Miklic', 'Affiliation': 'Clinical Hospital Center ""Sisters of Mercy"", Clinic of Traumatology, Draskoviceva 19, 10000 Zagreb, Croatia.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Oppermann', 'Affiliation': 'Genera Research, Svetonedeljska 2, Kalinovica, 10436, Rakov Potok, Croatia.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Bordukalo-Niksic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000 Zagreb, Croatia.'}, {'ForeName': 'Ismet', 'Initials': 'I', 'LastName': 'Gavrankapetanovic', 'Affiliation': 'University Clinical Center Sarajevo, Clinic of Orthopedics and Traumatology, Bolnicka 25, 71000 Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Mehmed', 'Initials': 'M', 'LastName': 'Jamakosmanovic', 'Affiliation': 'University Clinical Center Sarajevo, Clinic of Orthopedics and Traumatology, Bolnicka 25, 71000 Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Milosevic', 'Affiliation': 'School of Public Health ""Andrija Stampar"", University of Zagreb School of Medicine, Rockefellerova 4, 10000 Zagreb, Croatia.'}, {'ForeName': 'Snjezana', 'Initials': 'S', 'LastName': 'Martinovic', 'Affiliation': 'SmartMedico, Zupanova 5, 10000 Zagreb, Croatia.'}, {'ForeName': 'T Kuber', 'Initials': 'TK', 'LastName': 'Sampath', 'Affiliation': 'perFormBiologics Inc., Holliston, MA 01746, USA.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Peric', 'Affiliation': 'Department for Intracellular Communication, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 2, 10000 Zagreb, Croatia.'}, {'ForeName': 'Lovorka', 'Initials': 'L', 'LastName': 'Grgurevic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000 Zagreb, Croatia.'}, {'ForeName': 'Slobodan', 'Initials': 'S', 'LastName': 'Vukicevic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Salata 11, 10000 Zagreb, Croatia. Electronic address: slobodan.vukicevic@mef.hr.'}]",Bone,['10.1016/j.bone.2020.115551']
1749,32730946,"Domain-specific Involvement of the Right Posterior Parietal Cortex in Attention Network and Attentional Control of ADHD: A Randomized, Cross-over, Sham-controlled tDCS Study.","Transcranial direct current stimulation (tDCS) has been increasingly used in attention-deficit hyperactivity disorder (ADHD) with mixed results. Previous tDCS studies merely targeted the dorsolateral prefrontal cortex and right inferior frontal gyrus with partial or no improving effects on cognitive deficits respectively. Posterior parietal cortex is another region involved in attentional functioning of ADHD, however, its contribution to ADHD attention functions has not been explored in tDCS studies. Moreover, attention networks are not investigated in the previous tDCS studies in ADHD neither. Here, we explored the effects of anodal tDCS over the right posterior parietal cortex (r-PPC) on attentional functioning (i.e., attention networks, selective attention, shifting attention) and response inhibition in ADHD children. 19 children with ADHD were recruited and underwent anodal/sham r-PPC tDCS (1 mA, 20 min) during task performance in a randomized cross-over design. Our results show an improving effect of anodal r-PPC tDCS specifically on the orienting but alerting or executive networks, in line with findings of healthy populations. Furthermore, activation of the r-PPC had a deteriorating effect on the top-down attentional control required for selective attention measured by the Stroop test. Modeling of the current flow showed a stronger electrical field induced in the inferior PPC (BA 39,40) which mediates bottom-up attentional control. No significant effect on shifting attention and response inhibition was found. Our findings indicate a domain-specific involvement of the r-PPC in attention orienting network of ADHD children. Activation of the r-PPC improves bottom-up but hinders top-down attentional control suggesting a critical role of the r-PPC in ADHD bottom-up attentional control.",2020,"Our results show an improving effect of anodal r-PPC tDCS specifically on the orienting but alerting or executive networks, in line with findings of healthy populations.","['ADHD', 'ADHD children', '19 children with ADHD']","['Transcranial direct current stimulation (tDCS', 'anodal tDCS', 'anodal r-PPC tDCS', 'anodal/sham tDCS']","['attentional functioning (attention networks, selective attention, shifting attention', 'shifting attention and response inhibition']","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0456855', 'cui_str': 'Right posterior'}, {'cui': 'C0030560', 'cui_str': 'Parietal lobe structure'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",19.0,0.0442588,"Our results show an improving effect of anodal r-PPC tDCS specifically on the orienting but alerting or executive networks, in line with findings of healthy populations.","[{'ForeName': 'Mohammad Ali', 'Initials': 'MA', 'LastName': 'Salehinejad', 'Affiliation': 'Leibniz Research Centre for Working Environment and Human Factors, Department of Psychology and Neurosciences, Dortmund, Germany; Ruhr-University Bochum, International Graduate School of Neuroscience, Bochum, Germany; Department of Psychology, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Ghayerin', 'Affiliation': 'Department of Psychology, Shahid Beheshti University, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Nejati', 'Affiliation': 'Department of Psychology, Shahid Beheshti University, Tehran, Iran. Electronic address: nejati@sbu.ac.ir.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Yavari', 'Affiliation': 'Leibniz Research Centre for Working Environment and Human Factors, Department of Psychology and Neurosciences, Dortmund, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Leibniz Research Centre for Working Environment and Human Factors, Department of Psychology and Neurosciences, Dortmund, Germany; University Medical Hospital Bergmannsheil, Department of Neurology, Bochum, Germany.'}]",Neuroscience,['10.1016/j.neuroscience.2020.07.037']
1750,32746647,Is Lanreotide Really Useful in High Output Stoma? Comparison between Lanreotide to Conventional Antidiarrheal Treatment Alone.,"BACKGROUND


The incidence of high-output stoma (HOS) was reported to be approximately 3 to 16% in the literature, and HOS can cause dehydration. This complication is often severe enough to warrant hospital readmission and may result in renal failure. The aim of this study was to show a decrease of 50% in ileostomy output in the experimental arm using lanreotide treatment.
METHODS


Patients with an ileostomy output ≥ 1.5 l/24 hours were included in this prospective, open, multicentre randomized trial. Patients were randomly allocated between treatment arms with either lanreotide (LAN) and antidiarrhoeal treatments (TAD) (LAN-TAD group) or antidiarrhoeal treatments only (TADS group). The primary outcome was ileostomy output after 72 days. The secondary endpoints were ileostomy output during the first 6 days, blood urea and creatinine values, hospital length of stay and serious adverse events.
RESULTS


In the per-protocol analysis, there were nine patients in the control group (TADS) and six patients in the experimental group (TAD-LAN group). The stoma outputs at Day 3 (D3) in the experimental and control groups were 1,900 ± 855.7 mL and 1,728.6 ± 845.5 mL, respectively ( p  = 0.2). No differences were found concerning stoma output at D6, renal function, or hospital length of stay between the two groups.
CONCLUSION


The trial was prematurely stopped due to the low number of patients included. The question of the usefulness of somatostatin analogues in HOS persists, especially as the cost of this treatment is high, and there is a lack of evidence of its effectiveness.",2020,"No differences were found concerning stoma output at D6, renal function, or hospital length of stay between the two groups.
","['Patients with an ileostomy output ≥', '1.5\u2009l/24\u2009hours']","['Lanreotide', 'lanreotide treatment', 'lanreotide (LAN) and antidiarrhoeal treatments (TAD) (LAN-TAD group) or antidiarrhoeal treatments only (TADS group']","['stoma output at D6, renal function, or hospital length of stay', 'ileostomy output', 'ileostomy output during the first 6\u2009days, blood urea and creatinine values, hospital length of stay and serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}]","[{'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0057150', 'cui_str': 'DAT protocol 1'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0020883', 'cui_str': 'Creation of ileostomy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.099775,"No differences were found concerning stoma output at D6, renal function, or hospital length of stay between the two groups.
","[{'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Mesli', 'Affiliation': 'Department of Digestive Surgery, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Holterbach', 'Affiliation': 'Pôle de Santé Publique - Santé au Travail - Groupe Methode en Recherche Clinique CHRU Strasbourg, Strasbourg, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Delhorme', 'Affiliation': 'Department of Digestive Surgery, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Zaher', 'Initials': 'Z', 'LastName': 'Lakkis', 'Affiliation': 'Department of Digestive Surgery, Besançon University Hospital (Jean Minjoz), Besançon, France.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Ortega-Deballon', 'Affiliation': 'Department of Digestive Surgery, Dijon University Hospital, Dijon, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Deguelte', 'Affiliation': 'Department of Digestive Surgery, Reims University Hospital, Reims, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Rohr', 'Affiliation': 'Department of Digestive Surgery, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Brigand', 'Affiliation': 'Department of Digestive Surgery, Strasbourg University Hospital, Strasbourg, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meyer', 'Affiliation': 'Pôle de Santé Publique - Santé au Travail - Groupe Methode en Recherche Clinique CHRU Strasbourg, Strasbourg, France.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Romain', 'Affiliation': 'Department of Digestive Surgery, Strasbourg University Hospital, Strasbourg, France.'}]",Journal of investigative surgery : the official journal of the Academy of Surgical Research,['10.1080/08941939.2020.1800871']
1751,32750572,Clinical outcomes from the texting for relapse prevention (T4RP) in schizophrenia and schizoaffective disorder study.,"This 6 month randomized control trial investigated whether a novel text-messaging program impacted targeted clinical outcomes in patients with schizophrenia and schizoaffective disorder (SAD). Forty patients were enrolled and completed baseline, 3-month and 6-month assessments. The intervention group received daily symptom check-in text messages, plus, a medication reminder or, inspirational quote text. The control group had treatment as usual. At 6 months the Positive and Negative Syndrome Scale mean positive score was significantly lower and injectable medication compliance was significantly higher in the intervention group. Recovery scores were significantly higher at 3 months. Results suggest that this program may benefit individuals with schizophrenia/SAD who use text messaging. Further investigation in a larger sample appears warranted.",2020,At 6 months the Positive and Negative Syndrome Scale mean positive score was significantly lower and injectable medication compliance was significantly higher in the intervention group.,"['patients with schizophrenia and schizoaffective disorder (SAD', 'Forty patients were enrolled and completed baseline, 3-month and 6-month assessments']","['texting for relapse prevention (T4RP', 'daily symptom check-in text messages, plus, a medication reminder or, inspirational quote text', 'novel text-messaging program']","['Recovery scores', 'injectable medication compliance', 'Positive and Negative Syndrome Scale mean positive score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1283174', 'cui_str': 'Checking - action'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",40.0,0.0323144,At 6 months the Positive and Negative Syndrome Scale mean positive score was significantly lower and injectable medication compliance was significantly higher in the intervention group.,"[{'ForeName': 'Bernadette A', 'Initials': 'BA', 'LastName': 'Cullen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA; Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA. Electronic address: bcullen@jhmi.edu.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Eaton', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Mojtabai', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The Johns Hopkins Medical Institutions, Baltimore, Maryland, USA; Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Von Mach', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, USA.""}, {'ForeName': 'Michele L', 'Initials': 'ML', 'LastName': 'Ybarra', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA; Center for Innovative Public Health Research, San Clemente, California, USA.'}]",Psychiatry research,['10.1016/j.psychres.2020.113346']
1752,32750626,Association of patient preferences on medication discussion in hypertension: Results from a randomized clinical trial.,"Patient-centered care has received significant attention and is an integral component of high-quality healthcare. While it is often assumed that most prefer a patient-centered role orientation, such preferences exist along a continuum with some patients preferring a more provider-centered role. The present study examines patient preference data from a randomized clinical trial designed to test the efficacy of a patient activation intervention to promote thiazide prescribing for veteran patients with uncontrolled hypertension. Patient preferences for involvement in healthcare were assessed using the 9-item Sharing subscale of the Patient-Practitioner Orientation Scale (PPOS). The primary aim was to examine differences in discussion of thiazide use in the clinical encounter by those scoring high versus low on the PPOS. Five hundred ninety-five veteran patients were randomized to either one of three intervention groups or a usual care control group. The adjusted odds ratios (OR) for the three intervention groups relative to the control group indicated that thiazide discussion increased as a function of intervention intensity across both high and low PPOS groups. ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients. Results suggest that this patient activation intervention is effective for veteran patients representing a range of preferred involvement. Consideration of such preferences may be useful in tailoring future interventions in the healthcare context.",2020,"ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients.","['Five hundred ninety-five veteran patients', 'veteran patients with uncontrolled hypertension', 'hypertension']","['patient activation intervention', 'thiazide prescribing', 'thiazide', 'activation intervention', 'usual care control group']","['9-item Sharing subscale of the Patient-Practitioner Orientation Scale (PPOS', 'adjusted odds ratios (OR', 'function of intervention intensity']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012802', 'cui_str': 'Thiazide diuretic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",595.0,0.0335965,"ORs for the most intensive intervention group were 3.72 (95% CI = 1.61-8.65, p < .01) for high PPOS patients and 6.71 (95% CI = 2.59-10.67, p < .001) for low PPOS patients.","[{'ForeName': 'M Bryant', 'Initials': 'MB', 'LastName': 'Howren', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Department of Behavioral Sciences & Social Medicine, College of Medicine, Florida State University, Tallahassee, FL, USA. Electronic address: matthew.howren@med.fsu.edu.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Vander Weg', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Division of General Internal Medicine, The University of Iowa Carver College of Medicine, Iowa City, IA, USA; Department of Psychological & Brain Sciences, The University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Christensen', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kaboli', 'Affiliation': 'Center for Access Delivery Research & Evaluation (CADRE), VA Iowa City Healthcare System, Iowa City, IA, USA; Division of General Internal Medicine, The University of Iowa Carver College of Medicine, Iowa City, IA, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113244']
1753,32732573,Platelet-rich Plasma or Autologous Blood Do Not Reduce Pain or Improve Function in Patients with Lateral Epicondylitis: A Randomized Controlled Trial.,"BACKGROUND


Platelet-rich plasma (PRP) and autologous blood are commonly used therapies for lateral epicondylitis, but the evidence from randomized, placebo-controlled trials is conflicting. Thus, it is still unclear if patients benefit from these treatments.
QUESTIONS/PURPOSES


In the setting of a randomized, placebo-controlled trial, we compared PRP, autologous blood, and saline injections in the treatment of lateral epicondylitis with respect to: (1) VAS pain scores, and (2) functional outcomes (DASH score and grip strength) 1 year after treatment.
METHODS


We performed a parallel-group, randomized, controlled participant- and assessor-blinded study including adults with clinically diagnosed lateral epicondylitis. We defined lateral epicondylitis as pain in the lateral humeral epicondyle area exacerbated during resisted wrist extension and epicondyle compression. The participants were recruited from a secondary referral center, after not responding to initial nonoperative treatment. Patients with other concomitant upper-limb symptoms and surgical treatment of the elbow were excluded. Randomization sequence was generated with computer software and concealed from the investigators. We randomized 119 participants to receive an injection of PRP, autologous blood, or saline (1:1:1) in the proximal insertion of the extensor carpi radialis brevis muscle; 40 participants received PRP, 40 received autologous blood, and 39 received a saline injection. To prepare the PRP, we collected venous blood with a syringe kit followed by centrifugation, whereas autologous blood group received unprepared blood injection. Two unblinded investigators gave injections while the participant was unable to see the injection. There was no formal postinjection rehabilitation protocol and the use of NSAIDs was similar between different treatment arms. Follow-up visits were at 4, 8, 12, 26, and 52 weeks after the injection. The primary outcome measure was improvement in pain, measured with VAS scale (without specification as to whether the pain was activity related or at rest; range 0-10; a higher score indicates worse pain; the minimum clinically important difference [MCID] on the 10-cm scale was 1.5 cm), from baseline to 52 weeks. The secondary outcomes were the DASH score (range 0-100; a higher indicates a poorer outcome, and the MCID was 10.2 points) and grip strength. All patients were included in the analyses, and analyses were performed using the intention-to-treat principle. There was no crossover between treatment groups. At 52 weeks, nearly all (95% [38 of 40]) participants in autologous blood group were available for analysis whereas 78% (31 of 40) and 82% (32 of 39) were available in PRP and saline groups. This study was registered at ClinicalTrials.gov and funded by the local hospital district. With 40 patients in each group, we had 80% power to detect a clinically important improvement in pain (1.5 cm on the 10-cm VAS pain scale).
RESULTS


There were no clinically important differences in the mean VAS pain or DASH scores among the groups at any timepoint. At 52 weeks, the mean difference in the VAS score for pain was -0.2 (95% CI -1.5 to 1.1; p = 0.75) for PRP versus saline and 0.5 (95% CI -0.7 to 1.7; p = 0.40) for autologous blood versus saline. The corresponding mean differences in the DASH score were 0.0 (95% CI -9.2 to 9.2; p > 0.99) and 7.7 (95% CI -1.3 to 16.7; p = 0.09) and those for grip strength were 1.4 kg (95% CI -3.3 to 6.1; p = 0.56) and -0.2 kg (95% CI -5.0 to 4.5; p = 0.92). No complications occurred because of the injections.
CONCLUSIONS


PRP or autologous blood injections did not improve pain or function at 1 year of follow-up in people with lateral epicondylitis compared with those who were given a saline injection. However, because the 95% CIs did not exclude the MCID in VAS scores for autologous blood versus saline at 52 weeks, it is possible that a larger study could identify a between-group difference that we missed, but the effect size of that difference (based on our findings), even if present, is likely still to be small. Until or unless future randomized trials convincingly show a benefit either to PRP or autologous blood injections, we recommend against their use in patients with lateral epicondylitis.
LEVEL OF EVIDENCE


Level II, therapeutic study.",2020,"CONCLUSIONS


PRP or autologous blood injections did not improve pain or function at 1 year of follow-up in people with lateral epicondylitis compared with those who were given a saline injection.","['Patients with other concomitant upper-limb symptoms and surgical treatment of the elbow were excluded', 'participants were recruited from a secondary referral center, after not responding to initial nonoperative treatment', '119 participants to receive an', 'Patients with Lateral Epicondylitis', 'patients with lateral epicondylitis', 'adults with clinically diagnosed lateral epicondylitis']","['PRP or autologous blood injections', 'injection of PRP, autologous blood, or saline (1:1:1) in the proximal insertion of the extensor carpi radialis brevis muscle; 40 participants received PRP, 40 received autologous blood, and 39 received a saline injection', 'PRP versus saline', 'PRP, autologous blood, and saline injections', 'Platelet-rich Plasma or Autologous Blood', 'placebo']","['improvement in pain, measured with VAS scale', 'VAS score for pain', 'pain or function', '10-cm VAS pain scale', 'lateral epicondylitis with respect to: (1) VAS pain scores, and (2) functional outcomes (DASH score and grip strength', 'grip strength', 'pain', 'DASH score', 'mean VAS pain or DASH scores', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C3658282', 'cui_str': 'Secondary Referral Center'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C2957363', 'cui_str': 'Injection of platelet-rich plasma'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",119.0,0.492009,"CONCLUSIONS


PRP or autologous blood injections did not improve pain or function at 1 year of follow-up in people with lateral epicondylitis compared with those who were given a saline injection.","[{'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Linnanmäki', 'Affiliation': 'L. Linnanmäki, K. Kanto, J. Lehtinen, Tays Hatanpää Hospital, Tampere University Hospital, Tampere, Finland T. Karjalainen, Central Finland Central Hospital, Jyväskylä, Finland O. V. Leppänen, Department of Hand and Microsurgery, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Kanto', 'Affiliation': ''}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Karjalainen', 'Affiliation': ''}, {'ForeName': 'Olli V', 'Initials': 'OV', 'LastName': 'Leppänen', 'Affiliation': ''}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Lehtinen', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001185']
1754,32732574,CORR Insights®: Platelet-rich Plasma or Autologous Blood Do Not Reduce Pain or Improve Function in Patients with Lateral Epicondylitis: A Randomized Controlled Trial.,,2020,,['Patients with Lateral Epicondylitis'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039516', 'cui_str': 'Lateral epicondylitis'}]",[],[],,0.233205,,"[{'ForeName': 'Nash H', 'Initials': 'NH', 'LastName': 'Naam', 'Affiliation': 'N. H. Naam, Professor of Clinical Hand Surgery, Southern Illinois University, Southern Illinois Hand Center, Effingham, IL, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001249']
1755,32732583,Letter to the Editor: Does an Antimicrobial Incision Drape Prevent Intraoperative Contamination? A Randomized Controlled Trial of 1187 Patients.,,2020,,['1187 Patients'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],,0.137678,,"[{'ForeName': 'Zhen Chang', 'Initials': 'ZC', 'LastName': 'Liang', 'Affiliation': 'Z. C. Liang, M. S. Y. Chong, S. S. Tan, B. Z. Chin, D. Murphy, J. H. P. Hui, National University of Singapore, Department of Orthopaedic Surgery, National University Health System, Singapore.'}, {'ForeName': 'Mark Seng Ye', 'Initials': 'MSY', 'LastName': 'Chong', 'Affiliation': ''}, {'ForeName': 'Sara Shuhui', 'Initials': 'SS', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Brian Zhaojie', 'Initials': 'BZ', 'LastName': 'Chin', 'Affiliation': ''}, {'ForeName': 'Diarmuid', 'Initials': 'D', 'LastName': 'Murphy', 'Affiliation': ''}, {'ForeName': 'James Hoi Po', 'Initials': 'JHP', 'LastName': 'Hui', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001331']
1756,32736583,Online patient simulation training to improve clinical reasoning: a feasibility randomised controlled trial.,"BACKGROUND


Online patient simulations (OPS) are a novel method for teaching clinical reasoning skills to students and could contribute to reducing diagnostic errors. However, little is known about how best to implement and evaluate OPS in medical curricula. The aim of this study was to assess the feasibility, acceptability and potential effects of eCREST - the electronic Clinical Reasoning Educational Simulation Tool.
METHODS


A feasibility randomised controlled trial was conducted with final year undergraduate students from three UK medical schools in academic year 2016/2017 (cohort one) and 2017/2018 (cohort two). Student volunteers were recruited in cohort one via email and on teaching days, and in cohort two eCREST was also integrated into a relevant module in the curriculum. The intervention group received three patient cases and the control group received teaching as usual; allocation ratio was 1:1. Researchers were blind to allocation. Clinical reasoning skills were measured using a survey after 1 week and a patient case after 1 month.
RESULTS


Across schools, 264 students participated (18.2% of all eligible). Cohort two had greater uptake (183/833, 22%) than cohort one (81/621, 13%). After 1 week, 99/137 (72%) of the intervention and 86/127 (68%) of the control group remained in the study. eCREST improved students' ability to gather essential information from patients over controls (OR = 1.4; 95% CI 1.1-1.7, n = 148). Of the intervention group, most (80/98, 82%) agreed eCREST helped them to learn clinical reasoning skills.
CONCLUSIONS


eCREST was highly acceptable and improved data gathering skills that could reduce diagnostic errors. Uptake was low but improved when integrated into course delivery. A summative trial is needed to estimate effectiveness.",2020,"eCREST improved students' ability to gather essential information from patients over controls (OR = 1.4; 95% CI 1.1-1.7, n = 148).","['final year undergraduate students from three UK medical schools in academic year 2016/2017 (cohort one) and 2017/2018 (cohort two', '264 students participated (18.2% of all eligible', 'Student volunteers were recruited in cohort one via email and on teaching days, and in cohort two eCREST was also integrated into a relevant module in the curriculum']","['control group received teaching as usual; allocation ratio', 'Online patient simulation training']","['Clinical reasoning skills', 'clinical reasoning', 'Uptake']","[{'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517610', 'cui_str': '18.2'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0085137', 'cui_str': 'Patient Simulation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}]",264.0,0.147911,"eCREST improved students' ability to gather essential information from patients over controls (OR = 1.4; 95% CI 1.1-1.7, n = 148).","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Plackett', 'Affiliation': 'Department of Applied Health Research, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK. ruth.plackett.15@ucl.ac.uk.'}, {'ForeName': 'Angelos P', 'Initials': 'AP', 'LastName': 'Kassianos', 'Affiliation': 'Department of Applied Health Research, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kambouri', 'Affiliation': 'Institute of Education, UCL, London, UK.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Kay', 'Affiliation': 'Department of Applied Health Research, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Mylan', 'Affiliation': 'Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hopwood', 'Affiliation': 'UCL Medical School, UCL, London, UK.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Schartau', 'Affiliation': 'Primary Care and Population Health Department, UCL, London, UK.'}, {'ForeName': 'Shani', 'Initials': 'S', 'LastName': 'Gray', 'Affiliation': 'Department of Applied Health Research, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Timmis', 'Affiliation': 'Department of Applied Health Research, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bennett', 'Affiliation': 'UCL Medical School, UCL, London, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Valerio', 'Affiliation': 'UCL Medical School, UCL, London, UK.'}, {'ForeName': 'Veena', 'Initials': 'V', 'LastName': 'Rodrigues', 'Affiliation': 'Norwich Medical School, UEA, Norwich, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Player', 'Affiliation': 'Norwich Medical School, UEA, Norwich, UK.'}, {'ForeName': 'Willie', 'Initials': 'W', 'LastName': 'Hamilton', 'Affiliation': 'Institute of Health Service Research, University of Exeter, Exeter, UK.'}, {'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Raine', 'Affiliation': 'Department of Applied Health Research, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Duffy', 'Affiliation': 'Wolfson Institute of Preventive Medicine, QMUL, London, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Sheringham', 'Affiliation': 'Department of Applied Health Research, University College London, 1-19 Torrington Place, London, WC1E 7HB, UK.'}]",BMC medical education,['10.1186/s12909-020-02168-4']
1757,32736592,muLTi-Arm Therapeutic study in pre-ICu patients admitted with Covid-19-Experimental drugs and mechanisms (TACTIC-E): A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


To determine if a specific intervention reduces the composite of progression of patients with COVID-19-related disease to organ failure or death as measured by time to incidence of any one of the following: death, invasive mechanical ventilation, ECMO, cardiovascular organ support (inotropes or balloon pump), or renal failure (estimated Cockcroft Gault creatinine clearance <15ml/min).
TRIAL DESIGN


Randomised, parallel arm, open-label, adaptive platform Phase 2/3 trial of potential disease modifying therapies in patients with late stage 1/stage 2 COVID-19-related disease, with a diagnosis based either on a positive assay or high suspicion of COVID-19 infection by clinical, laboratory and radiological assessment.
PARTICIPANTS


Patients aged 18 and over, with a clinical picture strongly suggestive of COVID-19-related disease (with/without a positive COVID-19 test) AND a risk count (as defined below) >3 OR ≥3 if risk count includes ""Radiographic severity score >3"". A risk count is calculated by the following features on admission (1 point for each): radiographic severity score >3, male gender, non-white ethnicity, diabetes, hypertension, neutrophils >8.0 x10 9 /L, age >40 years and CRP >40 mg/L. Patients should be considered an appropriate subject for intervention with immunomodulatory or other disease modifying agents in the opinion of the investigator and are able to swallow capsules or tablets. The complete inclusion and exclusion criteria as detailed in the Additional file 1 should be fulfilled. Drug specific inclusion and exclusion criteria will also be applied to the active arms. Patients will be enrolled prior to the need for invasive mechanical ventilation, cardiac or renal support. Participants will be recruited across multiple centres in the UK including initially at Cambridge University Hospitals NHS Foundation Trust and St George's University NHS Foundation Trust. Other centres will be approached internationally in view of the evolving pandemic.
INTERVENTION AND COMPARATOR


There is increasing evidence of the role of immunomodulation in altering the course of COVID-19. Additionally, various groups have demonstrated the presence of pulmonary shunting in patients with COVID-19 as well as other cardiovascular complications. TACTIC-E will assess the efficacy of the novel immunomodulatory agent EDP1815 versus the approved cardio-pulmonary drugs, Dapagliflozin in combination with Ambrisentan versus the prevailing standard of care. EDP1815 will be given as 2 capsules twice daily (1.6 x 10 11  cells) for up to 7 days with the option to extend up to 14 days at the discretion of the principal investigator or their delegate, if the patient is felt to be clinically responding to treatment, is tolerating treatment, and is judged to be likely to benefit from a longer treatment course. Ambrisentan 5mg and Dapagliflozin 10mg will be given in combination once daily orally for up to maximum of 14 days. Patients will be randomised in a 1:1:1 ratio across treatments. Each active arm will be compared with standard of care alone. Additional arms may be added as the trial progresses. No comparisons will be made between active arms in this platform trial.
MAIN OUTCOMES


The primary outcome is the incidence (from baseline up to Day 14) to the occurrence of the any one of the following events: death, invasive mechanical ventilation, extra corporeal membrane oxygenation, cardiovascular organ support (inotropes or balloon pump), or renal failure (estimated Cockcroft Gault creatinine clearance <15ml/min).
RANDOMISATION


Eligible patients will be randomised using a central web-based randomisation service (Sealed Envelope) in a 1:1:1 ratio, stratified by site to one of the treatment arms or standard of care.
BLINDING (MASKING)


This is an open-label trial. Data analysis will not be blinded.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


There is no fixed sample size for this study. There will be an early biomarker-based futility analysis performed at a point during the study. If this biomarker futility analysis is not conclusive, then a second futility analysis based on clinical endpoints will be performed after approximately 125 patients have been recruited per arm. Provisionally, further analyses of clinical endpoints will be performed after 229 patients per active arm and later 469 patients per arm have been recruited. Further additional analyses may be triggered by the independent data monitoring committee.
TRIAL STATUS


TACTIC-E Protocol version number 1.0 date May 27 th , 2020. Recruitment starts on the 3 rd  of July 2020. The end trial date will be 18 months after the last patient's last visit and cannot be accurately predicted at this time.
TRIAL REGISTRATION


Registered on EU Clinical Trials Register EudraCT Number: 2020-002229-27 registered: 9 June 2020. The trial was also registered on ClinicalTrials.gov (NCT04393246) on 19 May 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"To determine if a specific intervention reduces the composite of progression of patients with COVID-19-related disease to organ failure or death as measured by time to incidence of any one of the following: death, invasive mechanical ventilation, ECMO, cardiovascular organ support (inotropes or balloon pump), or renal failure (estimated Cockcroft Gault creatinine clearance <15ml/min).
","['125 patients have been recruited per arm', 'patients with late stage', ""Participants will be recruited across multiple centres in the UK including initially at Cambridge University Hospitals NHS Foundation Trust and St George's University NHS Foundation Trust"", 'pre-ICu patients admitted with Covid-19-Experimental drugs and mechanisms (TACTIC-E', 'Patients aged 18 and over, with a clinical picture strongly suggestive of COVID-19-related disease (with/without a positive COVID-19 test) AND a risk count (as defined below) ', '229 patients per active arm and later 469 patients per arm have been recruited', 'Patients will be enrolled prior to the need for invasive mechanical ventilation, cardiac or renal support', 'patients with COVID-19-related disease to organ failure or death']","['specific intervention', 'EDP1815', 'Ambrisentan 5mg and Dapagliflozin']","['Radiographic severity score', 'presence of pulmonary shunting', 'death, invasive mechanical ventilation, ECMO, cardiovascular organ support (inotropes or balloon pump), or renal failure', 'incidence (from baseline up to Day 14) to the occurrence of the any one of the following events: death, invasive mechanical ventilation, extra corporeal membrane oxygenation, cardiovascular organ support (inotropes or balloon pump), or renal failure (estimated Cockcroft Gault creatinine clearance <15ml/min']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0013230', 'cui_str': 'Investigational New Drugs'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0011065', 'cui_str': 'Death'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1949327', 'cui_str': 'ambrisentan 5 MG'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0009346', 'cui_str': 'Balloon pump'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439232', 'cui_str': 'min'}]",,0.40292,"To determine if a specific intervention reduces the composite of progression of patients with COVID-19-related disease to organ failure or death as measured by time to incidence of any one of the following: death, invasive mechanical ventilation, ECMO, cardiovascular organ support (inotropes or balloon pump), or renal failure (estimated Cockcroft Gault creatinine clearance <15ml/min).
","[{'ForeName': 'Ing Ni', 'Initials': 'IN', 'LastName': 'Lu', 'Affiliation': 'Clinical Pharmacology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK. ing.lu@addenbrookes.nhs.uk.'}, {'ForeName': 'Spoorthy', 'Initials': 'S', 'LastName': 'Kulkarni', 'Affiliation': 'Clinical Pharmacology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Fisk', 'Affiliation': 'Clinical Pharmacology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Michalis', 'Initials': 'M', 'LastName': 'Kostapanos', 'Affiliation': 'Clinical Pharmacology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Banham-Hall', 'Affiliation': 'Clinical Pharmacology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Sonakshi', 'Initials': 'S', 'LastName': 'Kadyan', 'Affiliation': 'Clinical Pharmacology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bond', 'Affiliation': 'Clinical Pharmacology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Norton', 'Affiliation': 'Clinical Pharmacology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Cope', 'Affiliation': 'Clinical Pharmacology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Galloway', 'Affiliation': 'Clinical Pharmacology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Hall', 'Affiliation': 'Clinical Pharmacology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': 'Clinical Pharmacology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Wilkinson', 'Affiliation': 'Clinical Pharmacology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cheriyan', 'Affiliation': 'Clinical Pharmacology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}]",Trials,['10.1186/s13063-020-04618-2']
1758,32736596,"ACCORD: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES


Stage 1: To evaluate the safety and efficacy of candidate agents as add-on therapies to standard of care (SoC) in patients hospitalised with COVID-19 in a screening stage. Stage 2: To confirm the efficacy of candidate agents selected on the basis of evidence from Stage 1 in patients hospitalised with COVID-19 in an expansion stage.
TRIAL DESIGN


ACCORD is a seamless, Phase 2, adaptive, randomised controlled platform study, designed to rapidly test candidate agents in the treatment of COVID-19. Designed as a master protocol with each candidate agent being included via its own sub-protocol, initially randomising equally between each candidate and a single contemporaneous SoC arm (which can adapt into 2:1). Candidate agents currently include bemcentinib, MEDI3506, acalabrutinib, zilucoplan and nebulised heparin. For each candidate a total of 60 patients will be recruited in Stage 1. If Stage 1 provides evidence of efficacy and acceptable safety the candidate will enter Stage 2 where a total of approximately 126 patients will be recruited into each study arm sub-protocol. Enrollees and outcomes will not be shared across the Stages; the endpoint, analysis and sample size for Stage 2 may be adjusted based on evidence from Stage 1. Additional arms may be added as new potential candidate agents are identified via candidate agent specific sub-protocols.
PARTICIPANTS


The study will include hospitalised adult patients (≥18 years) with confirmed SARS-CoV-2 infection, the virus that causes COVID-19, that clinically meet Grades 3 (hospitalised - mild disease, no oxygen therapy), Grades 4 (hospitalised, oxygen by mask or nasal prongs) and 5 (hospitalised, non-invasive ventilation or high flow oxygen) of the WHO Working Group on the Clinical Characteristics of COVID-19 9-point category ordinal scale. Participants will be recruited from England, Northern Ireland, Wales and Scotland.
INTERVENTION AND COMPARATOR


Comparator is current standard of care (SoC) for the treatment of COVID-19. Current candidate experimental arms include bemcentinib, MEDI3506, acalabrutinib, zilucoplan and nebulised heparin with others to be added over time. Bemcentinib could potentially reduce viral infection and blocks SARS-CoV-2 spike protein; MEDI3506 is a clinic-ready anti-IL-33 monoclonal antibody with the potential to treat respiratory failure caused by COVID; acalabrutinib is a BTK inhibitor which is anti-viral and anti-inflammatory; zilucoplan is a complement C5 inhibitor which may block the severe inflammatory response in COVID-19 and; nebulised heparin has been shown to bind with the spike protein. ACCORD is linked with the UK national COVID therapeutics task force to help prioritise candidate agents.
MAIN OUTCOMES


Time to sustained clinical improvement of at least 2 points (from randomisation) on the WHO 9-point category ordinal scale, live discharge from the hospital, or considered fit for discharge (a score of 0, 1, or 2 on the ordinal scale), whichever comes first, by Day 29 (this will also define the ""responder"" for the response rate analyses).
RANDOMISATION


An electronic randomization will be performed by Cenduit using Interactive Response Technology (IRT). Randomisation will be stratified by baseline severity grade. Randomisation will proceed with an equal allocation to each arm and a contemporaneous SoC arm (e.g. 1:1 if control and 1 experimental arm; 1:1:1 if two experimental candidate arms etc) but will be reviewed as the trial progresses and may be changed to 2:1 in favour of the candidate agents.
BLINDING (MASKING)


The trial is open label and no blinding is currently planned in the study.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


This will be in the order of 60 patients per candidate agent for Stage 1, and 126 patients for Stage 2. However, sample size re-estimation may be considered after Stage 1. It is estimated that up to 1800 patients will participate in the overall study.
TRIAL STATUS


Master protocol version ACCORD-2-001 - Master Protocol (Amendment 1) 22 nd  April 2020, the trial has full regulatory approval and recruitment is ongoing in the bemcentinib (first patient recruited 6/5/2020), MEDI3506 (first patient recruited 19/5/2020), acalabrutinib (first patient recruited 20/5/2020) and zilucoplan (first patient recruited 19/5/2020) candidates (and SoC). The recruitment dates of each arm will vary between candidate agents as they are added or dropped from the trial, but will have recruited and reported within a year.
TRIAL REGISTRATION


EudraCT 2020-001736-95 , registered 28 th  April 2020.
FULL PROTOCOL


The full protocol (Master Protocol with each of the candidate sub-protocols) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,Bemcentinib could potentially reduce viral infection and blocks SARS-CoV-2 spike protein; MEDI3506 is a clinic-ready anti-IL-33 monoclonal antibody with the potential to treat respiratory failure caused by COVID; acalabrutinib is a BTK inhibitor which is anti-viral and anti-inflammatory; zilucoplan is a complement C5 inhibitor which may block the severe inflammatory response in COVID-19 and; nebulised heparin has been shown to bind with the spike protein.,"['patients hospitalised with COVID-19 in a screening stage', 'patients hospitalised with COVID-19 in an expansion stage', 'Participants will be recruited from England, Northern Ireland, Wales and Scotland', 'hospitalised adult patients (≥18 years) with confirmed SARS-CoV-2 infection, the virus that causes COVID-19, that clinically meet Grades 3 (hospitalised - mild disease, no oxygen therapy), Grades 4 (hospitalised, oxygen by mask or nasal prongs) and 5 (hospitalised, non-invasive ventilation or high flow oxygen) of the WHO Working Group on the Clinical Characteristics of COVID-19 9-point category ordinal scale', 'bemcentinib (first patient recruited 6/5/2020), MEDI3506 (first patient recruited 19/5/2020), acalabrutinib (first patient recruited 20/5/2020) and zilucoplan (first patient recruited 19/5/2020) candidates (and SoC', '22 nd  April 2020', '2020-001736-95', 'Hospitalised Patients', '1800 patients will participate in the overall study', '60 patients will be recruited in Stage 1', '60 patients per candidate agent for Stage 1, and 126 patients for Stage 2', 'Master protocol version ACCORD-2-001 - Master Protocol (Amendment 1', '126 patients will be recruited into each study arm sub-protocol']","['ACCORD', 'heparin', 'EudraCT']","['Time to sustained clinical improvement of at least 2 points (from randomisation) on the WHO 9-point category ordinal scale, live discharge from the hospital, or considered fit for discharge (a score of 0, 1, or 2 on the ordinal scale', 'Efficacy and Safety', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0028415', 'cui_str': 'Northern Ireland'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0036453', 'cui_str': 'Scotland'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0445087', 'cui_str': 'Nasal prongs'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4078312', 'cui_str': 'acalabrutinib'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0444649', 'cui_str': 'Master'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}]","[{'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.215769,Bemcentinib could potentially reduce viral infection and blocks SARS-CoV-2 spike protein; MEDI3506 is a clinic-ready anti-IL-33 monoclonal antibody with the potential to treat respiratory failure caused by COVID; acalabrutinib is a BTK inhibitor which is anti-viral and anti-inflammatory; zilucoplan is a complement C5 inhibitor which may block the severe inflammatory response in COVID-19 and; nebulised heparin has been shown to bind with the spike protein.,"[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Wilkinson', 'Affiliation': 'University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Dixon', 'Affiliation': 'IQVIA, Reading, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Page', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Miles', 'Initials': 'M', 'LastName': 'Carroll', 'Affiliation': 'Public Health England, London, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'University of Southampton, Southampton, Hampshire, UK. G.O.Griffiths@soton.ac.uk.'}, {'ForeName': 'Ling-Pei', 'Initials': 'LP', 'LastName': 'Ho', 'Affiliation': 'NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'De Soyza', 'Affiliation': 'Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Felton', 'Affiliation': 'Manchester NIHR Biomedical Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Keir E', 'Initials': 'KE', 'LastName': 'Lewis', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Phekoo', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Chalmers', 'Affiliation': 'University of Dundee, Dundee, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gordon', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': 'Lorcan', 'Initials': 'L', 'LastName': 'McGarvey', 'Affiliation': ""Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Doherty', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton, UK.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Read', 'Affiliation': 'University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Shankar-Hari', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Martinez-Alier', 'Affiliation': 'IQVIA, Reading, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Kelly"", 'Affiliation': 'IQVIA, Dublin, Ireland.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Duncan', 'Affiliation': 'IQVIA, Edinburgh, UK.'}, {'ForeName': 'Roelize', 'Initials': 'R', 'LastName': 'Walles', 'Affiliation': 'IQVIA, Reading, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sykes', 'Affiliation': 'IQVIA, Reading, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Summers', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'University of Manchester, Manchester, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04584-9']
1759,32736597,PROTECT Trial: A cluster-randomized study with hydroxychloroquine versus observational support for prevention or early-phase treatment of Coronavirus disease (COVID-19): A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES


Hydroxychloroquine has shown to have antiviral activity in vitro against coronaviruses, specifically SARS-CoV-2. It is believed to block virus infection by increasing endosomal pH required for virus cell fusion and glycosylation of viral surface proteins. In addition to its antiviral activity, hydroxychloroquine has an immune-modulating activity that may synergistically enhance its antiviral effect in vivo, making it a potentially promising drug for the prevention and the cure of SARS-CoV-19. However, randomized controlled trials are needed to assess whether it can be used safely to treat COVID-19 patients or to prevent infection. The main objective of the present study is to evaluate the efficacy of hydroxychloroquine for (I) the prevention of COVID-19 or related symptoms in SARS-CoV-2-exposed subjects, such as as household members/contacts of COVID-19 patients and (II) the treatment of early-phase asymptomatic or paucisymptomatic COVID-19 patients.
TRIAL DESIGN


This is a controlled, open label, cluster-randomized, superiority trial with parallel group design. Subjects will be randomized either to receive hydroxychloroquine or to observation (2:1).
PARTICIPANTS


SARS-CoV-2-exposed subjects, including household members and/or contacts of COVID-19 patients and healthcare professionals (Group 1) or patients with COVID-19 (positive PCR test on a rhinopharyngeal or oropharyngeal swab for SARS-CoV-2), asymptomatic or paucisymptomatic in home situations who are not undergoing treatment with any anti COVID-19 medication (Group 2), will be enrolled. Paucisymptomatic patients are defined as patients with a low number of mild symptoms. All subjects must be aged ≥18 years, male or female, must be willing and able to give informed consent and must not have any contraindications to take hydroxychloroquine (intolerance or previous toxicity for hydroxychloroquine/chloroquine, bradycardia or reduction in heart rhythm with arrhythmia, ischemic heart disease, retinopathy, congestive heart failure with use of diuretics, favism or glucose-6-phosphate dehydrogenase (G6PD) deficiency, diabetes type 1, major comorbidities such as advanced chronic kidney disease or dialysis therapy, known history of ventricular arrhythmia, any oncologic/hematologic malignancy, severe neurological and mental illness, current use of medications with known significant drug-drug interactions, and known prolonged QT syndrome or current use of drugs with known QT prolongation). The study is monocentric and will be conducted at Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS. Subjects will be enrolled from a large epidemic region (North-Central Italy). The Public Health Departments of several Italian regions will collaborate by identifying potentially eligible subjects.
INTERVENTION AND COMPARATOR


The participants will be randomized (2:1 randomization) to receive either hydroxychloroquine (Arm A) or to Observation (Arm B). Hydroxychloroquine will be administered with the following schedule: Group1: A loading dose hydroxychloroquine 400 mg twice daily on day 1, followed by a weekly dose of hydroxychloroquine 200 mg twice daily on days 8, 15 and 22, for a total of one month of treatment. Group 2: A loading dose hydroxychloroquine 400 mg twice daily on day 1 followed by 200 mg twice daily for a total of 5-7 days. The comparator in this trial is observation given that currently neither treatment is administered to asymptomatic or paucisymptomatic subjects, nor prophylaxis is available for contacts. Hydroxychloroquine will be shipped to subjects within 24 hours of randomization. Given the extraordinary nature of the COVID-19 pandemic, only telephonic interviews will be carried out and electronic Patient Reported Outcomes (ePRO) completed. During treatment, each subject will be contacted every other day for the first week and weekly thereafter (Group 2) or weekly (Group 1) by a study physician to assess early onset of any COVID-19 symptom or any adverse reaction to hydroxychloroquine and to check subject compliance. Furthermore, all subjects will receive periodic ePROs which may be completed through smartphone or tablets to record drug self-administration and onset of any symptom or adverse event. All subjects will be followed up for a total of 6 months by periodic telephonic interviews and ePROs.
MAIN OUTCOMES


The primary endpoint/outcome measure for this trial is: for Group 1, the proportion of subjects who become symptomatic and/or swab-positive in each arm within one month of randomization; for Group 2, the proportion of subjects who become swab-negative in each arm within 14 days of randomization.
RANDOMIZATION


All household members and/or contacts of each COVID-19 index case, and the COVID-19 patient himself/herself, fulfilling all inclusion criteria will be grouped into a single cluster and this cluster will be randomized (2:1) to either arm A or arm B. Information on each subject will be recorded in specific data records. Randomization lists will be stratified according to the following factors regarding COVID-19 index cases: 1. COVID-19 risk level on the basis of province of residence (high vs. low/intermediate); 2. Index case is a healthcare professional (yes vs.no) 3. Index case with COVID-19 treatment (yes vs. no) An independent statistician not otherwise involved in the trial will generate the allocation sequence, and COVID-19 response teams will be unaware of the allocation of clusters. Randomization will be performed through an interactive web-based electronic data-capturing database. An Independent Data Monitoring Committee has been established.
BLINDING (MASKING)


This study is open label.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


For Group 1, a sample size of about 2000 SARS-CoV-2-exposed subjects such as household members and/or contacts of COVID-19 patients will take part in the study. Assuming around 1.5-2.0 asymptomatic household members and/or contacts for each COVID-19 patient, we expect to identify approximately 1000-1300 COVID-19 index cases to be randomized. An interim analysis on efficacy is planned using standard alpha-spending function. For Group 2, sufficient power for primary objective (negative swab within 14 days of randomization) will be reached given a sample size of 300 asymptomatic or paucisymptomatic COVID-19 subjects in home situations not treated for COVID-19 (25%-30% of about 1000-1300 expected index cases). Since up to date reduced evidence about COVID-19 infection epidemiology, the continuous update of diagnostic and therapeutic approaches, the sample size estimation could be updated after a one third of population will be recruited and eventually modified according to a substantial protocol amendment. An interim analysis at 100 enrolled COVID-19 patients is planned. We have planned a Generalized Estimating Equation analysis, which is more efficient than a cluster level analysis, to take advantage of subject-specific covariates. The above reported sample size analysis is therefore to be considered conservative.
TRIAL STATUS


The current version of the PROTECT trial protocol is 'Final version, 15 April 2020'. The study started on 9 th  May 2020. The first patient was enrolled on 14 th  May 2020. Recruitment is expected to last through September 2020.
TRIAL REGISTRATION


The PROTECT trial is registered in the EudraCT database (no. 2020-001501-24) and in ClinicalTrials.gov ( NCT04363827 ), date of registration 24 April 2020.
FULL PROTOCOL


The full PROTECT protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interests of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol (Protocol final version, 15 th  April 2020). The study protocol has been reported in accordance with Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"We have planned a Generalized Estimating Equation analysis, which is more efficient than a cluster level analysis, to take advantage of subject-specific covariates.","['SARS-CoV-2-exposed subjects, such as as household members/contacts of COVID-19 patients and (II) the treatment of early-phase asymptomatic or paucisymptomatic COVID-19 patients', 'Subjects will be enrolled from a large epidemic region (North-Central Italy', 'in heart rhythm with arrhythmia, ischemic heart disease, retinopathy, congestive heart failure with use of diuretics, favism or glucose-6-phosphate dehydrogenase (G6PD) deficiency, diabetes type 1, major comorbidities such as advanced chronic kidney disease or dialysis therapy, known history of ventricular arrhythmia, any oncologic/hematologic malignancy, severe neurological and mental illness', 'SARS-CoV-2-exposed subjects, including household members and/or contacts of COVID-19 patients and healthcare professionals (Group 1) or patients with COVID-19 (positive PCR test on a rhinopharyngeal or oropharyngeal swab for SARS-CoV-2), asymptomatic or paucisymptomatic in home situations who are not undergoing treatment with any anti COVID-19 medication (Group 2), will be enrolled', '2000 SARS-CoV-2-exposed subjects such as household members', 'All subjects must be aged ≥18 years, male or female', 'Coronavirus disease (COVID-19']","['hydroxychloroquine (intolerance', 'hydroxychloroquine', 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS', 'Hydroxychloroquine', 'hydroxychloroquine/chloroquine, bradycardia or reduction']",['proportion of subjects who become symptomatic and/or swab-positive'],"[{'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0151744', 'cui_str': 'Myocardial ischemia'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0015702', 'cui_str': 'Favism'}, {'cui': 'C2939465', 'cui_str': 'Deficiency of glucose-6-phosphate dehydrogenase'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011946', 'cui_str': 'Dialysis procedure'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0085612', 'cui_str': 'Ventricular arrhythmia'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0376545', 'cui_str': 'Hematologic neoplasm'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",,0.210316,"We have planned a Generalized Estimating Equation analysis, which is more efficient than a cluster level analysis, to take advantage of subject-specific covariates.","[{'ForeName': 'Oriana', 'Initials': 'O', 'LastName': 'Nanni', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy. oriana.nanni@irst.emr.it.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Viale', 'Affiliation': 'Dipartimento di Scienze Mediche e Chirurgiche, Università di Bologna, Bologna, Italy.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Vertogen', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lilli', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Zingaretti', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Donati', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Masini', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Monti', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Serra', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Vespignani', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Veruska', 'Initials': 'V', 'LastName': 'Grossi', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Annibale', 'Initials': 'A', 'LastName': 'Biggeri', 'Affiliation': 'Dipartimento di Statistica, Informatica, Applicazioni ""G. Parenti"" (DISIA), Università degli studi Firenze, Florence, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Scarpi', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Galardi', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Bertoni', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Americo', 'Initials': 'A', 'LastName': 'Colamartini', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Falcini', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Altini', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Massa', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Gaggeri', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Martinelli', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}]",Trials,['10.1186/s13063-020-04527-4']
1760,32737993,Clinical trial readiness study of distal myopathy and dysphagia in nephropathic cystinosis.,"BACKGROUND


Nephropathic cystinosis is a lysosomal storage disorder with late-onset systemic complications, such as myopathy and dysphagia. Currently employed outcome measures lack sensitivity and responsiveness for dysphagia and myopathy, a limitation to clinical trial readiness.
METHODS


We evaluated 20 patients with nephropathic cystinosis in two visits over the course of a year to identify outcomes sensitive to detect changes over time. Patients also underwent an expiratory muscle strength training program to assess any effects on aspiration and dysphagia.
RESULTS


There were significant differences in the Timed Up and Go Test (TUG) and Timed 25-Foot Walk (25-FW) between baseline and 1-y follow-up (P < .05). Maximum expiratory pressure (MEP) and peak cough flow (PCF) significantly improved following respiratory training (P < .05).
CONCLUSIONS


Improved respiratory outcomes may enhance patients ability to expel aspirated material from the airway, stave off pulmonary sequelae associated with chronic aspiration, and yield an overall improvement in physical health and well-being.",2020,"Maximum Expiratory Pressure (MEP) and Peak Cough Flow (PCF) significantly improved following respiratory training (p < 0.05).
","['Distal Myopathy and Dysphagia in Nephropathic Cystinosis', '20 patients with nephropathic cystinosis in two visits over the course of a year']",['expiratory muscle strength training program'],"['Timed Up and Go Test (TUG) and Timed 25-Foot Walk (25-FW', 'Maximum Expiratory Pressure (MEP) and Peak Cough Flow (PCF']","[{'cui': 'C0751336', 'cui_str': 'Distal muscular dystrophy'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0015624', 'cui_str': 'Fanconi syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}]",20.0,0.0494736,"Maximum Expiratory Pressure (MEP) and Peak Cough Flow (PCF) significantly improved following respiratory training (p < 0.05).
","[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Sadjadi', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Sullivan', 'Affiliation': 'Department of Speech, Language and Swallowing Disorders, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Grant', 'Affiliation': 'Center for Rare Neurological Diseases, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Thomas', 'Affiliation': 'Division of Pediatric Nephrology, Department of Pediatrics and Communicable Diseases, University of Michigan School of Medicine, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Doyle', 'Affiliation': 'Department of Social Work, School of Health Sciences, Quinnipiac University, Hamden, Connecticut, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Hammond', 'Affiliation': 'Cystinosis Adult Care Excellence Initiative, Reading, Massachusetts, USA.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Corre', 'Affiliation': 'Center for Rare Neurological Diseases, Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Mello', 'Affiliation': 'Center for Rare Neurological Diseases, Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'David', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Eichler', 'Affiliation': 'Center for Rare Neurological Diseases, Department of Neurology, Massachusetts General Hospital, Boston, Massachusetts, USA.'}]",Muscle & nerve,['10.1002/mus.27039']
1761,32738019,"Lipoatrophy in children, adolescents and adults with insulin pump treatment: Is there a beneficial effect of insulin glulisine?","AIM


To investigate whether zinc-free insulin is an effective treatment option for lipoatrophy.
METHODS


Controlled, randomized, open-label parallel study in young people with type 1 diabetes, pump treatment and lipoatrophy at injection sites. Participants underwent dermatological examination and evaluation of affected areas using ultrasound and magnetic resonance imaging (MRI). After randomization, half of themswitched to insulin glulisine (intervention group) for 6 months. The control group continued their treatment with zinc-containing insulin and switched to insulin glulisine 6 months later. Both groups were followed-up until month 12. Primary endpoint was the increase of the relative thickness of the subcutaneous fat layer of the most atrophic site at 6 months as documented by MRI.
RESULTS


Fourteen participants were included into the study. While relative thickness of subcutaneous fat tissue was comparable between intervention (-60% [-98.8 - -17.6], n = 7) and control group (-50% [-72.7 - -1.0], P = .511; median (range), n = 7)at baseline, it improved in the intervention (-14.3% [-85.7-83.3] vs -31.3% (-66.7-0), P = .031), but not in the control group (P = .125) after 6 months. At 12 months, relative fat thickness (P = .003), number (P = .015) and size of most atrophic sites (P = .001) were improved in the intervention group. Number (P = .018) and size of most atrophic sites (P = .008) were also reduced in the control group between 6 and 12 months.
CONCLUSIONS


Although the present pilot study is based on a small sample, the data give first hint that the use of the zinc-free insulin glulisine may be beneficial in people with diabetes, pump and lipoatrophy.",2020,"At 12 months, relative fat thickness (p=.003), number (p=.015) and size of most atrophic sites (p=.001) were improved in the intervention group.","['children, adolescents and adults with insulin pump treatment', 'young people with type 1 diabetes, pump treatment and lipoatrophy at injection sites', 'Fourteen participants were included into the study']","['zinc-containing insulin and switched to insulin glulisine 6 months later', 'Lipoatrophy', 'zinc-free insulin']","['number (p=.015) and size of most atrophic sites', 'relative thickness of the subcutaneous fat layer of the most atrophic site at 6 months as documented by MRI', 'relative fat thickness', 'relative thickness of subcutaneous fat tissue', 'size of most atrophic sites']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0023787', 'cui_str': 'Lipodystrophy'}, {'cui': 'C0221208', 'cui_str': 'Injection site'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1313386', 'cui_str': 'Insulin, Glulisine, Human'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0023787', 'cui_str': 'Lipodystrophy'}, {'cui': 'C0487017', 'cui_str': 'Free insulin'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}]",14.0,0.0696432,"At 12 months, relative fat thickness (p=.003), number (p=.015) and size of most atrophic sites (p=.001) were improved in the intervention group.","[{'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kordonouri', 'Affiliation': ""Diabetes Center for Children and Adolescents at the Children's Hospital AUF DER BULT, Hannover, Germany.""}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Biester', 'Affiliation': ""Diabetes Center for Children and Adolescents at the Children's Hospital AUF DER BULT, Hannover, Germany.""}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Weidemann', 'Affiliation': ""Pediatric Radiology at the Children's Hospital AUF DER BULT, Hannover, Germany.""}, {'ForeName': 'Hagen', 'Initials': 'H', 'LastName': 'Ott', 'Affiliation': ""Pediatric Dermatology at the Children's Hospital AUF DER BULT, Hannover, Germany.""}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Remus', 'Affiliation': ""Diabetes Center for Children and Adolescents at the Children's Hospital AUF DER BULT, Hannover, Germany.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Grothaus', 'Affiliation': ""Pediatric Dermatology at the Children's Hospital AUF DER BULT, Hannover, Germany.""}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Pisarek', 'Affiliation': ""Diabetes Center for Children and Adolescents at the Children's Hospital AUF DER BULT, Hannover, Germany.""}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Hartmann', 'Affiliation': ""Diabetes Center for Children and Adolescents at the Children's Hospital AUF DER BULT, Hannover, Germany.""}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Adolph', 'Affiliation': ""Diabetes Center for Children and Adolescents at the Children's Hospital AUF DER BULT, Hannover, Germany.""}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Medical Psychology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Diabetes Center for Children and Adolescents at the Children's Hospital AUF DER BULT, Hannover, Germany.""}]",Pediatric diabetes,['10.1111/pedi.13094']
1762,32738042,Phase 3 Trial of a Small-volume Subcutaneous 6-Month Duration Leuprolide Acetate Treatment for Central Precocious Puberty.,"CONTEXT


Gonadotropin-releasing hormone agonists (GnRHas) are standard of care for central precocious puberty (CPP). A 6-month subcutaneous injection has recently been approved by the Food and Drug Administration.
OBJECTIVE


Determine efficacy, pharmacokinetics, and safety of 6-month 45-mg subcutaneous leuprolide acetate for CPP.
DESIGN


Phase 3 multicenter, open-label, single-arm study.
SETTING


25 sites in 6 countries.
SUBJECTS


64 GnRHa-naïve children with CPP (age: 7.5 ± 0.1 years) received study drug: 59 completed the study.
INTERVENTION(S)


2 doses of 45-mg subcutaneous leuprolide acetate (0.375 mL) at 0 and 24 weeks; children were followed for 48 weeks.
MAIN OUTCOME MEASURE(S)


Percentage of children with serum luteinizing hormone (LH) <4 IU/L 30 minutes following GnRHa stimulation at week 24.
RESULTS


54/62 (87%) children achieved poststimulation LH <4 IU/L at week 24; 49/56 (88%) girls and 1/2 boys maintained peak LH <4 IU/L at week 48. Mean growth velocity decreased from 8.9 cm/year at week 4 to 6.0 cm/year at week 48. Mean bone age was advanced 3.0 years beyond chronological age at screening and 2.7 years at week 48. Breast pubertal stage regressed or was stable in 97% of girls and external genitalia development regressed in both boys. Adverse events were mild and did not cause treatment discontinuation.
CONCLUSIONS


A small volume of 45-mg subcutaneous leuprolide acetate administered at a 6-month interval effectively suppressed pubertal hormones and stopped or caused regression of pubertal progression. This long-acting GnRHa preparation of leuprolide acetate is a new, effective, and well-tolerated therapy for children with CPP.",2020,Breast pubertal stage regressed or was stable in 97% of girls and external genitalia development regressed in both boys.,"['Mean bone age was advanced 3.0 years beyond chronological age at screening and 2.7 years at week 48', '64 GnRHa naive children with CPP (age: 7.5±0.1 years) received study drug: 59 completed the study', 'children with CPP', '25 sites in 6 countries', 'central precocious puberty']","['Gonadotropin releasing hormone agonists (GnRHa', 'leuprolide acetate treatment', 'leuprolide acetate', 'subcutaneous leuprolide acetate', 'luteinizing hormone (LH', '6-month 45 mg subcutaneous leuprolide acetate']","['pubertal hormones and stopped or caused regression of pubertal progression', 'Mean growth velocity', 'Adverse events']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429620', 'cui_str': 'Bone age'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0342543', 'cui_str': 'Central precocious puberty'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0700596', 'cui_str': 'Leuprolide acetate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0790454,Breast pubertal stage regressed or was stable in 97% of girls and external genitalia development regressed in both boys.,"[{'ForeName': 'Karen O', 'Initials': 'KO', 'LastName': 'Klein', 'Affiliation': ""Rady Children's Hospital and University of California, San Diego, California.""}, {'ForeName': 'Analía', 'Initials': 'A', 'LastName': 'Freire', 'Affiliation': 'Centro de Investigaciones Endocrinológicas ""Dr. César Bergadá"" (CEDIE) CONICET - FEI - División de Endocrinología, Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina.'}, {'ForeName': 'Mirta Graciela', 'Initials': 'MG', 'LastName': 'Gryngarten', 'Affiliation': 'Centro de Investigaciones Endocrinológicas ""Dr. César Bergadá"" (CEDIE) CONICET - FEI - División de Endocrinología, Hospital de Niños Ricardo Gutierrez, Buenos Aires, Argentina.'}, {'ForeName': 'Gad B', 'Initials': 'GB', 'LastName': 'Kletter', 'Affiliation': 'MultiCare Institute for Research and Innovation, Tacoma, Washington.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Benson', 'Affiliation': ""Nemours Children's Hospital, Orlando, Florida.""}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Miller', 'Affiliation': ""University of Minnesota Masonic Children's Hospital, Minneapolis, Minnesota.""}, {'ForeName': 'Tala S', 'Initials': 'TS', 'LastName': 'Dajani', 'Affiliation': 'School of Osteopathic Medicine in Arizona, A.T. Still University, Mesa, Arizona.'}, {'ForeName': 'Erica A', 'Initials': 'EA', 'LastName': 'Eugster', 'Affiliation': 'Riley Hospital for Children at Indiana University Health, Indianapolis, Indiana.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Mauras', 'Affiliation': ""Nemours Children's Health System, Jacksonville, Florida.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa479']
1763,32735987,"A two-site, open-label, non-randomized trial comparing Focal Electrically-Administered Seizure Therapy (FEAST) and right unilateral ultrabrief pulse electroconvulsive therapy (RUL-UBP ECT).","BACKGROUND


Focal Electrically-Administered Seizure Therapy (FEAST) is a form of electroconvulsive therapy (ECT) that spatially focuses the electrical stimulus to initiate seizure activity in right prefrontal cortex. Two open-label non-comparative studies suggested that FEAST has reduced cognitive side effects when compared to historical data from other forms of ECT. In two different ECT clinics, we compared the efficacy and cognitive side effects of FEAST and Right Unilateral Ultrabrief Pulse (RUL-UBP) ECT.
METHODS


Using a non-randomized, open-label design, 39 depressed adults were recruited after referral for ECT. Twenty patients received FEAST (14 women; age 45.2 ± 12.7), and 19 received RUL-UBP ECT (16 women; age 43.2 ± 16.4). Key cognitive outcome measures were the postictal time to reorientation and the Columbia University Autobiographical Memory Interview: Short-Form (CUAMI-SF). Antidepressant effects were assessed using the Hamilton Rating Scale for Depression (HRSD 24 ).
RESULTS


In the Intent-to-treat sample, a repeated measures mixed model suggested no between group difference in HRSD 24  score over time (F 1,35  = 0.82, p = 0.37), while the response rate favored FEAST (FEAST: 65%; RUL-UBP ECT: 57.9%), and the remission rate favored RUL-UBP ECT (FEAST: 35%; RUL-UBP ECT: 47.4%). The FEAST group had numeric superiority in average time to reorientation (FEAST: 6.6 ± 5.0 min; RUL-UBP ECT: 8.8 ± 5.8 min; Cohens d = 0.41), and CUAMI-SF consistency score (FEAST: 69.2 ± 14.2%; RUL-UBP ECT: 63.9 ± 9.9%; Cohens d = 0.43); findings that failed to meet statistical significance.
CONCLUSIONS


FEAST exerts similar efficacy relative to an optimal form of conventional ECT and may have milder cognitive side effects. A blinded, randomized, non-inferiority trial is needed.",2020,"The FEAST group had numeric superiority in average time to reorientation (FEAST: 6.6±5.0 minutes; RUL-UBP ECT: 8.8±5.8 minutes; Cohens d = 0.41), and CUAMI-SF consistency score (FEAST: 69.2±14.2%; RUL-UBP ECT: 63.9±9.9%; Cohens d = 0.43); findings that failed to meet statistical significance.
","['Twenty patients received FEAST (14 women; age 45.2±12.7), and 19 received', '39 depressed adults were recruited after referral for ECT']","['electroconvulsive therapy (ECT', 'FEAST and Right Unilateral Ultrabrief Pulse (RUL-UBP) ECT', 'Focal Electrically-Administered Seizure Therapy (FEAST) and Right Unilateral Ultrabrief Pulse Electroconvulsive Therapy (RUL-UBP ECT', 'RUL-UBP ECT', 'FEAST', 'Focal Electrically-Administered Seizure Therapy (FEAST']","['cognitive side effects', 'CUAMI-SF consistency score', 'efficacy and cognitive side effects', 'postictal time to reorientation and the Columbia University Autobiographical Memory Interview: Short-Form (CUAMI-SF', 'Hamilton Rating Scale for Depression (HRSD 24 ', 'numeric superiority', 'Antidepressant effects', 'HRSD 24  score over time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0451013', 'cui_str': 'Autobiographical memory interview'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",39.0,0.0739028,"The FEAST group had numeric superiority in average time to reorientation (FEAST: 6.6±5.0 minutes; RUL-UBP ECT: 8.8±5.8 minutes; Cohens d = 0.41), and CUAMI-SF consistency score (FEAST: 69.2±14.2%; RUL-UBP ECT: 63.9±9.9%; Cohens d = 0.43); findings that failed to meet statistical significance.
","[{'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Sahlem', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA. Electronic address: sahlem@musc.edu.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'E Baron', 'Initials': 'EB', 'LastName': 'Short', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Fox', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Nagy A', 'Initials': 'NA', 'LastName': 'Youssef', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Manett', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Kerns', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Morgan M', 'Initials': 'MM', 'LastName': 'Dancy', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA.'}, {'ForeName': 'Laryssa', 'Initials': 'L', 'LastName': 'McCloud', 'Affiliation': 'Department of Psychiatry and Health Behavior, GA, USA; Medical College of Georgia, GA, USA; Augusta University, GA, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, SC, USA; Ralph H. Johnson VA Medical Center, SC, USA.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Departments of Psychiatry and Radiology, Columbia University, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.07.015']
1764,32738206,Determinants of Cardiorespiratory Fitness After Bariatric Surgery: Insights From a Randomised Controlled Trial of a Supervised Training Program.,"BACKGROUND


Severely obese patients have decreased cardiorespiratory fitness (CRF) and poor functional capacity. Bariatric surgery-induced weight loss improves CRF, but the determinants of this improvement are not well known. We aimed to assess the determinants of CRF before and after bariatric surgery and the impact of an exercise training program on CRF after bariatric surgery.
METHODS


Fifty-eight severely obese patients (46.1 ± 6.1 kg/m 2 , 78% women) were randomly assigned to either an exercise group (n = 39) or usual care (n = 19). Exercise training was conducted from the 3rd to the 6th months after surgery. Anthropometric measurements, abdominal and mid-thigh computed tomographic scans, resting echocardiography, and maximal cardiopulmonary exercise testing was performed before bariatric surgery and 3 and 6 months after surgery.
RESULTS


Weight, fat mass, and fat-free mass were reduced significantly at 3 and 6 months, without any additive impact of exercise training in the exercise group. From 3 to 6 months, peak aerobic power (V̇O 2peak ) increased significantly (P < 0.0001) in both groups but more importantly in the exercise group (exercise group: from 18.6 ± 4.2 to 23.2 ± 5.7 mL/kg/min; control group: from 17.4 ± 2.3 to 19.7 ± 2.4 mL/kg/min; P value, group × time = 0.01). In the exercise group, determinants of absolute V̇O 2peak  (L/min) were peak exercise ventilation, oxygen pulse, and heart rate reserve (r 2  = 0.92; P < 0.0001), whereas determinants of V̇O 2peak  indexed to body mass (mL/kg/min) were peak exercise ventilation and early-to-late filling velocity ratio (r 2  = 0.70; P < 0.0001).
CONCLUSIONS


A 12-week supervised training program has an additive benefit on cardiorespiratory fitness for patients who undergo bariatric surgery.",2020,"From 3 to 6 months, peak aerobic power (V̇O 2peak ) increased significantly (P < 0.0001) in both groups but more importantly in the exercise group (exercise group: from 18.6 ± 4.2 to 23.2 ± 5.7 mL/kg/min; control group: from 17.4 ± 2.3 to 19.7 ± 2.4 mL/kg/min; P value, group ","['Fifty-eight severely obese patients (46.1 ± 6.1 kg/m 2 , 78% women', 'Severely obese patients', 'patients who undergo bariatric surgery']","['exercise group (n\xa0= 39) or usual care', 'exercise training program', 'Exercise training', 'exercise training']","['peak aerobic power (V̇O 2peak ', 'Weight, fat mass, and fat-free mass', 'absolute V̇O 2peak  (L/min) were peak exercise ventilation, oxygen pulse, and heart rate reserve ', 'V̇O 2peak  indexed to body mass', 'cardiorespiratory fitness (CRF', 'peak exercise ventilation and early-to-late filling velocity ratio', 'Cardiorespiratory Fitness', 'cardiorespiratory fitness']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",58.0,0.0370399,"From 3 to 6 months, peak aerobic power (V̇O 2peak ) increased significantly (P < 0.0001) in both groups but more importantly in the exercise group (exercise group: from 18.6 ± 4.2 to 23.2 ± 5.7 mL/kg/min; control group: from 17.4 ± 2.3 to 19.7 ± 2.4 mL/kg/min; P value, group ","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Auclair', 'Affiliation': 'Québec Heart and Lung Institute, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Jany', 'Initials': 'J', 'LastName': 'Harvey', 'Affiliation': 'Québec Heart and Lung Institute, Laval University, Québec, Québec, Canada; Faculty of Pharmacy, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Jacinthe', 'Initials': 'J', 'LastName': 'Leclerc', 'Affiliation': 'Québec Heart and Lung Institute, Laval University, Québec, Québec, Canada; Faculty of Pharmacy, Laval University, Québec, Québec, Canada; Nursing Department, Université du Québec à Trois-Rivières, Trois-Rivières, Québec, Canada.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Piché', 'Affiliation': 'Québec Heart and Lung Institute, Laval University, Québec, Québec, Canada; Faculty of Medicine, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': ""O'Connor"", 'Affiliation': 'Québec Heart and Lung Institute, Laval University, Québec, Québec, Canada; Faculty of Medicine, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Nadreau', 'Affiliation': 'Québec Heart and Lung Institute, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Pettigrew', 'Affiliation': 'Québec Heart and Lung Institute, Laval University, Québec, Québec, Canada; Faculty of Pharmacy, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Haykowsky', 'Affiliation': 'Faculty of Nursing, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Marceau', 'Affiliation': 'Québec Heart and Lung Institute, Laval University, Québec, Québec, Canada; Faculty of Medicine, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Biertho', 'Affiliation': 'Québec Heart and Lung Institute, Laval University, Québec, Québec, Canada; Faculty of Medicine, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Frédéric-Simon', 'Initials': 'FS', 'LastName': 'Hould', 'Affiliation': 'Québec Heart and Lung Institute, Laval University, Québec, Québec, Canada; Faculty of Medicine, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Stéfane', 'Initials': 'S', 'LastName': 'Lebel', 'Affiliation': 'Québec Heart and Lung Institute, Laval University, Québec, Québec, Canada; Faculty of Medicine, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Biron', 'Affiliation': 'Québec Heart and Lung Institute, Laval University, Québec, Québec, Canada; Faculty of Medicine, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Julien', 'Affiliation': 'Québec Heart and Lung Institute, Laval University, Québec, Québec, Canada; Faculty of Medicine, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Léonie', 'Initials': 'L', 'LastName': 'Bouvet', 'Affiliation': 'Québec Heart and Lung Institute, Laval University, Québec, Québec, Canada; Faculty of Medicine, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Lescelleur', 'Affiliation': 'Québec Heart and Lung Institute, Laval University, Québec, Québec, Canada; Faculty of Medicine, Laval University, Québec, Québec, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Poirier', 'Affiliation': 'Québec Heart and Lung Institute, Laval University, Québec, Québec, Canada; Faculty of Pharmacy, Laval University, Québec, Québec, Canada. Electronic address: paul.poirier@criucpq.ulaval.ca.'}]",The Canadian journal of cardiology,['10.1016/j.cjca.2020.03.032']
1765,32738573,"Effect of multispecies probiotic on gut microbiota composition in individuals with intestinal constipation: A double-blind, placebo-controlled randomized trial.","OBJECTIVE


The aim of this study was to evaluate the effect of a multispecies probiotic on gut microbiota composition and constipation symptoms.
METHODS


A randomized, double-blind, placebo-controlled clinical trial was conducted with 35 individuals with constipation for 30 days. The individuals were randomized into two groups: the control capsule (CC) and the probiotic capsule (PC) groups. Constipation symptoms were evaluated by the ROME IV criteria and by evacuation diaries. Fecal microbiota was analyzed by 16 S rRNA gene sequencing.
RESULTS


The majority of participants were women (85.7%). There was a significant reduction in the percent of participants who had incomplete defecation (P = 0.034), blockage sensation (P = 0.025), and rarely present liquid stools without the aid of laxatives (P = 0.046) only within the PC group (but no significant difference between groups). There was a significant increase in the relative abundance percentage of Blautia faecis and Ruminococcus torques in the CC group (P = 0.003 and P = 0.011, respectively), although there was no significant change in the PC group (P = 0.794 and P = 0.958, respectively), with a significant difference between groups (P = 0.029 and P 0.013, respectively), suggesting that probiotic treatment prevented the increase of percent relative abundance of these two species.
CONCLUSION


These results suggest that multispecies probiotics in capsule form may modulate gut microbiota by reducing the bacteria that are commonly increased in patients with constipation, contributing to the balance of microbiota and, consequently, to the well-being of the individual. Future studies with larger numbers of patients are required.",2020,"There was a significant reduction in the percent of participants who had incomplete defecation (P = 0.034), blockage sensation (P = 0.025), and rarely present liquid stools without the aid of laxatives (P = 0.046) only within the PC group (but no significant difference between groups).","['individuals with intestinal constipation', '35 individuals with constipation for 30 days', 'patients with constipation']","['control capsule (CC) and the probiotic capsule (PC', 'multispecies probiotic', 'placebo']","['incomplete defecation', 'gut microbiota composition and constipation symptoms', 'Constipation symptoms', 'blockage sensation', 'Fecal microbiota', 'gut microbiota composition', 'relative abundance percentage of Blautia faecis and Ruminococcus torques']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C2658870', 'cui_str': 'Blautia'}, {'cui': 'C0318074', 'cui_str': 'Ruminococcus'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",35.0,0.289849,"There was a significant reduction in the percent of participants who had incomplete defecation (P = 0.034), blockage sensation (P = 0.025), and rarely present liquid stools without the aid of laxatives (P = 0.046) only within the PC group (but no significant difference between groups).","[{'ForeName': 'Patrícia Borges', 'Initials': 'PB', 'LastName': 'Botelho', 'Affiliation': 'Department of Nutrition, Faculty of Health Sciences, University of Brasília, Brasília, Brazil. Electronic address: patriciabotelho@unb.br.'}, {'ForeName': 'Marcus Vinícius Rodrigues', 'Initials': 'MVR', 'LastName': 'Ferreira', 'Affiliation': 'Department of Nutrition, Faculty of Health Sciences, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Ananda de Mesquita', 'Initials': 'AM', 'LastName': 'Araújo', 'Affiliation': 'Department of Nutrition, Faculty of Health Sciences, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Marcela Moraes', 'Initials': 'MM', 'LastName': 'Mendes', 'Affiliation': 'Department of Nutrition, Faculty of Health Sciences, University of Brasília, Brasília, Brazil.'}, {'ForeName': 'Eduardo Yoshio', 'Initials': 'EY', 'LastName': 'Nakano', 'Affiliation': 'Statistics Department, University of Brasilia, Brasília, Brazil.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110890']
1766,32738599,Tumor infiltrating lymphocytes after neoadjuvant IRX-2 immunotherapy in oral squamous cell carcinoma: Interim findings from the INSPIRE trial.,"OBJECTIVES


IRX-2 is a primary-cell-derived immune-restorative consisting of multiple human cytokines that act to overcome tumor-mediated immunosuppression and provide an in vivo tumor vaccination to increase tumor infiltrating lymphocytes (TILs). A randomized phase II trial was conducted of the IRX regimen 3 weeks prior to surgery consisting of an initial dose of cyclophosphamide followed by 10 days of regional perilymphatic IRX-2 cytokine injections and daily oral indomethacin, zinc and omeprazole (Regimen 1) compared to the identical regimen without IRX-2 cytokines (Regimen 2).
METHODS


A total of 96 patients with previously untreated, stage II-IV oral cavity SCC were randomized 2:1 to experimental (1) or control (2) regimens (64:32). Paired biopsy and resection specimens from 62 patients were available for creation of tissue microarray (n = 39), and multiplex immunohistology (n = 54). Increases in CD8+ TIL infiltrate scores of at least 10 cells/mm 2  were used to characterize immune responders (IR).
RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2. In p16 negative cancers (n = 26), significant increases in CD8+ and overall TILs were evident in Regimen 1 (p = 0.004, and 0.04 respectively). IRs were more frequent in Regimen 1 (74% vs 31%, p = 0.01). Multiplex immunohistology for PD-L1 expression confirmed an increase in PD-L1 H score for Regimen 1 compared to Regimen 2 (p = 0.11).
CONCLUSIONS


The findings demonstrate significant increases in TILs after perilymphatic IRX-2 injections. Three quarters of patients showed significant immune responses to IRX-2. (NCT02609386).",2020,"RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","['96 patients with previously untreated, stage II-IV oral cavity SCC', 'oral squamous cell carcinoma']","['indomethacin, zinc and omeprazole', 'cyclophosphamide', 'neoadjuvant IRX-2 immunotherapy']","['PD-L1 H score', 'CD8+ TIL infiltrate scores', 'CD8+ infiltrates', 'CD8+ and overall TILs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}]","[{'cui': 'C0021246', 'cui_str': 'Indomethacin'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0758290', 'cui_str': 'IRX 2'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}]","[{'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",96.0,0.0184539,"RESULTS


Regimen 1 was associated with significant increases in CD8+ infiltrates (p = 0.01) compared to Regimen 2.","[{'ForeName': 'Gregory T', 'Initials': 'GT', 'LastName': 'Wolf', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States. Electronic address: gregwolf@umich.edu.'}, {'ForeName': 'Siyu', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bellile', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Sartor', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rozek', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Dafydd', 'Initials': 'D', 'LastName': 'Thomas', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Nguyen', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Zarins', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Jonathan B', 'Initials': 'JB', 'LastName': 'McHugh', 'Affiliation': 'Michigan Medicine, University of Michigan, Ann Arbor, MI 48109, United States.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Oral oncology,['10.1016/j.oraloncology.2020.104928']
1767,32738662,"Reaching reliable change using short, daily, cognitive training exercises delivered on a mobile application: The case of Relationship Obsessive Compulsive Disorder (ROCD) symptoms and cognitions in a subclinical cohort.","BACKGROUND


Relationship Obsessive Compulsive Disorder (ROCD) is a presentation of OCD centering on interpersonal relationships. The aim of this Randomized Control Trial (RCT) was to assess the efficacy of short, game like, daily cognitive interventions delivered via mobile application in reducing subclinical ROCD symptoms and associated phenomena.
METHODS


Fifty university students identified as having subclinical levels of ROCD symptoms (using the Structured Clinical Interview for DSM-5 Clinical Version) were randomized into: immediate-use group (iApp group; n = 25) and delayed-use group (dApp group; n = 25). The iApp group started using the evaluated cognitive-behavioral training application at baseline for 15 days (T0 to T1). The dApp group commenced using the application at T1 for 15 days (T1 to T2). All participants completed questionnaires at baseline (T0), 15 days from baseline (T1), and 30 days from baseline (T2).
RESULTS


Repeated measure MANOVAs showed significant Group (iApp vs. dApp) × Time (T0 vs. T1) interactions. These interactions indicated greater decrease in ROCD symptoms, OCD beliefs and social anxiety symptoms, as well as a greater increase in self-esteem in the iApp group compared to dApp group at T1. Moreover, the Reliable Change Index (RCI) indicated reliable change on ROCD symptoms for a significant portion of participants (42-52%).
LIMITATIONS


Sample size and the use of self-report measures limits the generalizability of the results.
CONCLUSIONS


Short, daily cognitive training interventions delivered via mobile applications may be useful in reducing subclinical ROCD symptoms and associated features. Further testing is needed for clinical populations.",2020,"Moreover, the Reliable Change Index (RCI) indicated reliable change on ROCD symptoms for a significant portion of participants (42-52%).
",['Fifty university students identified as having subclinical levels of ROCD symptoms (using the Structured Clinical Interview for DSM-5 Clinical Version'],"['immediate-use group (iApp group; n\xa0=\xa025) and delayed-use group (dApp group; n\xa0=\xa025', 'cognitive training exercises delivered on a mobile application']","['subclinical ROCD symptoms', 'Relationship Obsessive Compulsive Disorder (ROCD) symptoms and cognitions', 'ROCD symptoms, OCD beliefs and social anxiety symptoms', 'subclinical ROCD symptoms and associated phenomena', 'self-esteem', 'ROCD symptoms']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0199182', 'cui_str': 'History taking'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C2607870', 'cui_str': 'Version'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0063684', 'cui_str': 'Amylin'}, {'cui': 'C0088932', 'cui_str': '1-(diethylaminopropyl)-4-phenylpiperazine'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}]",,0.0611703,"Moreover, the Reliable Change Index (RCI) indicated reliable change on ROCD symptoms for a significant portion of participants (42-52%).
","[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cerea', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy. Electronic address: silvia.cerea@unipd.it.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Ghisi', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy.'}, {'ForeName': 'Gioia', 'Initials': 'G', 'LastName': 'Bottesi', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Carraro', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Broggio', 'Affiliation': 'Department of General Psychology, University of Padova, Via Venezia, 8, 35131 Padua, Italy.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Doron', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center Herzliya, PO Box 167, Herzliya 46150, Israel. Electronic address: gdoron@idc.ac.il.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.043']
1768,32756094,"Pureed diets containing a gelling agent to reduce the risk of aspiration in elderly patients with moderate to severe dysphagia: A randomized, crossover trial.","GOALS


The aim of this study was to evaluate the effectiveness of adding a gelling agent to pureed diets to prevent aspiration pneumonia in elderly patients with moderate to severe dysphagia.
BACKGROUND


Pureed diets are often used to reduce aspiration in patients with dysphagia. However, the ideal texture of a pureed diet to prevent aspiration pneumonia remains unclear.
MATERIALS AND METHODS


We prospectively conducted a randomized, crossover trial of pureed rice with or without a gelling agent in patients with moderate to severe dysphagia (ClincialTrials.gov number, NCT03163355). The primary outcome measure was pharyngeal residuals using an endoscopic scoring system. The secondary outcome was the sense of material remaining in the throat following swallowing.
RESULTS


Sixty two patients (58% men), mean age 83 ± 9 years with moderate to severe dysphagia were included. Residuals in the throat were significantly less likely with pureed rice with than without the gelling agent (median cyclic ingestion score (range); 1 (0-4) vs 2 (0-4); P = .001). Irrespective of the presence or absence of the gelling agent, the sense of material remaining in the throat was significantly less frequent in older patients (87 ± 7.6 vs 75 ± 9.1 years, P < .01; 86 ± 7.3 vs 75 ± 8.6 years, P < .01).
CONCLUSIONS


Pureed diets containing a gelling agent may reduce the risk of aspiration pneumonia possibly by decreasing pharyngeal residues in elderly patients with moderate to severe dysphagia.",2020,Residuals in the throat were significantly less likely with pureed rice with than without the gelling agent (median cyclic ingestion score (range); 1 (0-4) vs 2 (0-4); P = .001).,"['patients with dysphagia', 'Sixty two patients (58% men), mean age 83\u200a±\u200a9 years with moderate to severe dysphagia were included', 'elderly patients with moderate to severe dysphagia', 'patients with moderate to severe dysphagia (ClincialTrials.gov number, NCT03163355']","['gelling agent to pureed diets', 'Pureed diets containing a gelling agent']","['pharyngeal residuals using an endoscopic scoring system', 'sense of material remaining in the throat following swallowing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0452392', 'cui_str': 'Pureed diet'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}]",,0.0556869,Residuals in the throat were significantly less likely with pureed rice with than without the gelling agent (median cyclic ingestion score (range); 1 (0-4) vs 2 (0-4); P = .001).,"[{'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Kyodo', 'Affiliation': 'Department of Pediatrics, Juntendo University Faculty of Medicine, Tokyo.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Kudo', 'Affiliation': 'Department of Pediatrics, Juntendo University Faculty of Medicine, Tokyo.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Horiuchi', 'Affiliation': 'Digestive Disease Center.'}, {'ForeName': 'Torao', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Rehabilitation, Showa Inan General Hospital, Komagane, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': 'Department of Pediatrics, Juntendo University Faculty of Medicine, Tokyo.'}]",Medicine,['10.1097/MD.0000000000021165']
1769,32756101,Protocol paper for the Movimente school-based program: A cluster-randomized controlled trial targeting physical activity and sedentary behavior among Brazilian adolescents.,"BACKGROUND


A better understanding of how multicomponent school-based interventions work and their effects on health and education outcomes are needed. This paper described the methods of the Movimente Program, a school-based intervention that aims to increase physical activity (PA) and decrease sedentary behavior (SB) among Brazilian students.
METHODS


This is a cluster randomized controlled trial with adolescents from 7th to 9th grade in public schools from Florianopolis, Southern Brazil. After agreement, 6 schools were randomly selected to intervention or control groups (3 schools each), and all eligible students were invited to the study. The Movimente intervention program was performed during a school year and included 3 main components: Teacher training (including face-to-face meeting, social media platform, and handbook with lesson plans); improvements in the PA environment in school; and educational strategies. Control schools continued with their traditional schedule. Baseline (March/April 2017), postintervention (November/December 2017), and maintenance (June/July 2018) evaluations included PA and SB as primary outcomes (assessed by self-report and accelerometry). Secondary outcomes included psychosocial factors related to PA and SB (e.g., social support and self-efficacy), as well as health (e.g., quality of life and nutritional status) and education (e.g., academic achievement) outcomes. A program evaluation was performed based on the RE-AIM framework. Participants, intervention staffs, and evaluators were not blinded to group assignment, but a standardized evaluation protocol was applied independently of the trial allocation.
RESULTS


Statistical analyses will include a multilevel approach for repeated measurements and mediation analysis. Any side effects of the intervention will be recorded. The sample size close to that expected (n = 1090) was reached (n = 999). The results of this trial will involve valuable information about the effect and the evaluation of a multicomponent intervention carried out in a middle-income country.
CONCLUSION


By creating opportunities for adolescents to be active at school using multicomponent strategies, the Movimente program has the potential to enhance students health and academic performance which may encourage the school community (e.g., teachers, principals) to adopt the program. Also, this trial will provide evidence for practitioners, policy makers, and researchers on how multicomponent program may be implemented in a school setting.
TRIAL REGISTRATION


The trial is registered at the Clinical Trial Registry (Trial ID: NCT02944318; date of registration: 18 October 2016).",2020,"Participants, intervention staffs, and evaluators were not blinded to group assignment, but a standardized evaluation protocol was applied independently of the trial allocation.
","['Brazilian adolescents', 'adolescents from 7th to 9th grade in public schools from Florianopolis, Southern Brazil', '6 schools were randomly selected to intervention or control groups (3 schools each), and all eligible students were invited to the study', 'Movimente school-based program', 'Brazilian students']","['Movimente intervention program was performed during a school year and included 3 main components: Teacher training (including face-to-face meeting, social media platform, and handbook with lesson plans']","['physical activity (PA) and decrease sedentary behavior (SB', 'psychosocial factors related to PA and SB (e.g., social support and self-efficacy), as well as health (e.g., quality of life and nutritional status) and education (e.g., academic achievement) outcomes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C4082803', 'cui_str': 'Teacher Training'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0596654', 'cui_str': 'Handbooks'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",6.0,0.0468859,"Participants, intervention staffs, and evaluators were not blinded to group assignment, but a standardized evaluation protocol was applied independently of the trial allocation.
","[{'ForeName': 'Kelly Samara', 'Initials': 'KS', 'LastName': 'Silva', 'Affiliation': 'Department of Physical Education, Research Centre in Physical Activity and Health, Sport Centre, Federal University of Santa Catarina, Florianopolis.'}, {'ForeName': 'Jaqueline Aragoni da', 'Initials': 'JAD', 'LastName': 'Silva', 'Affiliation': 'Department of Physical Education, Research Centre in Physical Activity and Health, Sport Centre, Federal University of Santa Catarina, Florianopolis.'}, {'ForeName': 'Valter Cordeiro', 'Initials': 'VC', 'LastName': 'Barbosa Filho', 'Affiliation': 'Federal Institute of Education, Science and Technology of Ceara, Aracati, Brazil.'}, {'ForeName': 'Priscila Cristina Dos', 'Initials': 'PCD', 'LastName': 'Santos', 'Affiliation': 'Department of Physical Education, Research Centre in Physical Activity and Health, Sport Centre, Federal University of Santa Catarina, Florianopolis.'}, {'ForeName': 'Pablo Magno da', 'Initials': 'PMD', 'LastName': 'Silveira', 'Affiliation': 'Department of Physical Education, Research Centre in Physical Activity and Health, Sport Centre, Federal University of Santa Catarina, Florianopolis.'}, {'ForeName': 'Marcus V V', 'Initials': 'MVV', 'LastName': 'Lopes', 'Affiliation': 'Department of Physical Education, Research Centre in Physical Activity and Health, Sport Centre, Federal University of Santa Catarina, Florianopolis.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Salmon', 'Affiliation': 'Institute for Physical Activity and Nutrition, Faculty of Health, Deakin University, Victoria, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021233']
1770,32756135,Analgesic effect of extracorporeal shock-wave therapy for frozen shoulder: A randomized controlled trial protocol.,"BACKGROUND


Till date only a few studies have reported the efficacy and clinical improvements obtained by extracorporeal shock-wave therapy (ESWT) on frozen shoulder. Limited by small number of studies and insufficient outcomes, it is important and necessary to conduct a new randomized controlled trial. The purpose of the present study is to determine whether ESWT could be more effective than oral steroid in treatment of frozen shoulder.
METHODS


This randomized, single-blind, superiority clinical trial was approved by the institutional review board in The Third People's Hospital of Linyi. The inclusion criteria were patients aged >18 years with shoulder pain and restriction in range of motion. A symptom duration >3 months was required, with no radiographic findings on anteroposterior shoulder plain radiographs except for osteoporosis. Group 1 patients were given 30 mg of oral prednisolone daily for 2 weeks as a single morning dose and then 15 mg daily for another 2 weeks. Group 2 patients received 3 sessions of ESWT on the first, 14th, and 28th days. The primary outcome measure was shoulder pain score. The secondary outcomes included Disabilities of the Arm, Shoulder, and Hand score, range of motion, satisfaction rate, and complications.
RESULTS


It was hypothesized that there would be a significant difference between ESWT and control groups in improving shoulder pain and functions in frozen shoulder.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5736).",2020,"The secondary outcomes included Disabilities of the Arm, Shoulder, and Hand score, range of motion, satisfaction rate, and complications.
","[""Third People's Hospital of Linyi"", 'frozen shoulder', 'patients aged >18 years with shoulder pain and restriction in range of motion']","['oral prednisolone', 'extracorporeal shock-wave therapy', 'ESWT', 'extracorporeal shock-wave therapy (ESWT']","['Analgesic effect', 'shoulder pain score', 'shoulder pain and functions', 'Disabilities of the Arm, Shoulder, and Hand score, range of motion, satisfaction rate, and complications']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0311223', 'cui_str': 'Adhesive capsulitis of shoulder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0460094', 'cui_str': 'Within reference range'}, {'cui': 'C0026597', 'cui_str': 'Motion'}]","[{'cui': 'C0358513', 'cui_str': 'Prednisolone-containing product in oral dose form'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.190963,"The secondary outcomes included Disabilities of the Arm, Shoulder, and Hand score, range of motion, satisfaction rate, and complications.
","[{'ForeName': 'Han-Yong', 'Initials': 'HY', 'LastName': 'Qiao', 'Affiliation': 'Department of Special Inspection.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Xin', 'Affiliation': ""Department of Pathology, The Third People's Hospital of Linyi, Shandong, 276023, China.""}, {'ForeName': 'Shao-Lan', 'Initials': 'SL', 'LastName': 'Wu', 'Affiliation': 'Department of Special Inspection.'}]",Medicine,['10.1097/MD.0000000000021399']
1771,32756643,"Effects of probiotic therapy on cardio-metabolic parameters and autonomic modulation in hypertensive women: a randomized, triple-blind, placebo-controlled trial.","BACKGROUND AND AIMS


We assessed the effects of probiotic therapy for 8 weeks on cardiometabolic variables and autonomic function in women medically diagnosed with arterial hypertension.
METHODS AND RESULTS


Forty women with arterial hypertension, 20-50 years, were assigned to two groups in this randomized, triple-blind, placebo-controlled clinical trial. Patients in the probiotic group received a daily sachet containing Lactobacillus para casei LPC-37, Lactobacillus rhamnosus HN001, Lactobacillus acidophilus NCFM, and Bifidobacterium lactis HN019 (109 CFU of each strain) for 8 weeks. Patients in the placebo group received identical sachets with polydextrose (1 g day-1, for 8 weeks). Anthropometric, BP, electrocardiogram, biochemical measurements, fecal microbiota composition, and glucose hydrogen breath test were assessed at baseline and after 8 weeks intervention. Anthropometric variables (weight, BMI, and waist circumference) were similar between the two groups (p > 0.05). Probiotic supplementation significantly reduced fasting glucose (change -10.3 mg dL-1, p < 0.05) and cholesterol levels (change -23.6 mg dL-1, p < 0.05), and increased the HDL-cholesterol (change 6.5 mg dL-1, p < 0.05) compared with the baseline condition. Probiotic supplementation lowered, although without statistical significance, systolic BP by about 5 mmHg and diastolic BP by about 2 mmHg in hypertensive women. Lastly, probiotic administration reduced the low frequency (LF) oscillation and LF/high frequency (HF) ratio (p < 0.05) in the frequency domain of heart rate variability, suggesting an improvement in autonomic modulation.
CONCLUSION


Probiotic therapy for 8 weeks reduced fasting glucose levels, and improved the lipid profile and autonomic modulation in hypertensive women.",2020,"Probiotic supplementation significantly reduced fasting glucose (change -10.3 mg dL-1, p < 0.05) and cholesterol levels (change -23.6 mg dL-1, p < 0.05), and increased the HDL-cholesterol (change 6.5 mg dL-1, p < 0.05) compared with the baseline condition.","['women medically diagnosed with arterial hypertension', 'Forty women with arterial hypertension, 20-50 years', 'hypertensive women']","['probiotic therapy', 'identical sachets with polydextrose', 'Probiotic supplementation', 'Probiotic therapy', 'daily sachet containing Lactobacillus para casei LPC-37, Lactobacillus rhamnosus', 'placebo']","['cardiometabolic variables and autonomic function', 'cholesterol levels', 'fasting glucose levels', 'lipid profile and autonomic modulation', 'fasting glucose', 'diastolic BP', 'Anthropometric, BP, electrocardiogram, biochemical measurements, fecal microbiota composition, and glucose hydrogen breath test', 'autonomic modulation', 'HDL-cholesterol', 'HN001, Lactobacillus acidophilus NCFM, and Bifidobacterium lactis HN019 ', 'systolic BP', 'Anthropometric variables (weight, BMI, and waist circumference', 'low frequency (LF) oscillation and LF/high frequency (HF) ratio', 'cardio-metabolic parameters and autonomic modulation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C2242626', 'cui_str': 'Probiotic therapy'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}, {'cui': 'C0071545', 'cui_str': 'polydextrose'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0344439', 'cui_str': 'Hydrogen breath test'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",40.0,0.218213,"Probiotic supplementation significantly reduced fasting glucose (change -10.3 mg dL-1, p < 0.05) and cholesterol levels (change -23.6 mg dL-1, p < 0.05), and increased the HDL-cholesterol (change 6.5 mg dL-1, p < 0.05) compared with the baseline condition.","[{'ForeName': 'Larissa de Fátima', 'Initials': 'LF', 'LastName': 'Romão da Silva', 'Affiliation': 'Department of Nutrition, Health Sciences Center, Federal University of Paraiba, João Pessoa, Brazil. jose_luiz_61@hotmail.com jose.luiz@academico.ufpb.br.'}, {'ForeName': 'Yohanna', 'Initials': 'Y', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Nutrition, Health Sciences Center, Federal University of Paraiba, João Pessoa, Brazil. jose_luiz_61@hotmail.com jose.luiz@academico.ufpb.br.'}, {'ForeName': 'Evandro Leite', 'Initials': 'EL', 'LastName': 'de Souza', 'Affiliation': 'Department of Nutrition, Health Sciences Center, Federal University of Paraiba, João Pessoa, Brazil. jose_luiz_61@hotmail.com jose.luiz@academico.ufpb.br.'}, {'ForeName': 'Micaelle Oliveira', 'Initials': 'MO', 'LastName': 'de Luna Freire', 'Affiliation': 'Biotechnology Center, Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Valdir de Andrade', 'Initials': 'VA', 'LastName': 'Braga', 'Affiliation': 'Biotechnology Center, Federal University of Paraíba, João Pessoa, Brazil.'}, {'ForeName': 'Marciane', 'Initials': 'M', 'LastName': 'Magnani', 'Affiliation': 'Department of Food Engineering, Technology Center, Federal University of Paraíba, Joao Pessoa, Brazil.'}, {'ForeName': 'José Luiz', 'Initials': 'JL', 'LastName': 'de Brito Alves', 'Affiliation': 'Department of Nutrition, Health Sciences Center, Federal University of Paraiba, João Pessoa, Brazil. jose_luiz_61@hotmail.com jose.luiz@academico.ufpb.br.'}]",Food & function,['10.1039/d0fo01661f']
1772,32756661,"Effects of plant oils with different fatty acid composition on cardiovascular risk factors in moderately hypercholesteremic Chinese adults: a randomized, double-blinded, parallel-designed trial.","OBJECTIVES


Plant oil for cooking typically provides 40% to 50% of dietary fat, 65% of linoleic acid, 44% of α-linolenic acid and 41% of oleic acid in the Chinese diet. However, the comparative effects of fatty acids derived from plant oil on cardiovascular risk factors in Chinese are still inconclusive. Hence, the aim of this study is to investigate whether cardiovascular risk factors are altered depending on various types of plant oils such as peanut oil rich in oleic acid, corn oil rich in linoleic acid, and blend oil fortified by α-linolenic acid.
DESIGN


A randomized, double-blinded, parallel-designed trial.
SETTING


The First and the Second Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
PARTICIPANTS


A total of 251 volunteers with fasting blood total cholesterol between 5.13 and 8.00 mmol L -1  were enrolled.
INTERVENTION


Volunteers received peanut oil, corn oil or blend oil to use for cooking for one year.
MAIN OUTCOME MEASURES


The erythrocyte membrane fatty acid composition, fasting plasma lipids, glucose and insulin concentrations and high sensitivity C-reactive protein (hsCRP) levels were measured before, during and after the intervention. The level of α-linolenic acid in erythrocyte membranes was significantly increased in the blend oil group after the intervention (P < 0.001). The level of other fatty acids did not show any statistically significant differences between the three groups. No significant differences were observed in the concentrations of fasting plasma lipids, hsCRP, glucose, and insulin among the three groups using different types of plant oils.
CONCLUSIONS


The results suggest that although ingesting cooking oil with different fatty acid composition for one year could change erythrocyte membrane fatty acid compositions, it did not significantly modify cardiovascular risk factors in moderately hypercholesteremic people.",2020,The level of α-linolenic acid in erythrocyte membranes was significantly increased in the blend oil group after the intervention (P < 0.001).,"['moderately hypercholesteremic Chinese adults', 'A total of 251 volunteers with fasting blood total cholesterol between 5.13 and 8.00 mmol L-1 were enrolled', 'moderately hypercholesteremic people']","['linoleic acid', 'oleic acid', 'plant oils with different fatty acid composition', 'fatty acids derived from plant oil', 'peanut oil, corn oil or blend oil to use for cooking for one year']","['concentrations of fasting plasma lipids, hsCRP, glucose, and insulin', 'level of other fatty acids', 'level of α-linolenic acid in erythrocyte membranes', 'cardiovascular risk factors', 'erythrocyte membrane fatty acid composition, fasting plasma lipids, glucose and insulin concentrations and high sensitivity C-reactive protein (hsCRP) levels']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0600472', 'cui_str': 'L1 Elements'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0023749', 'cui_str': 'Linoleic acid'}, {'cui': 'C0028928', 'cui_str': '9 cis-octadecenoic acid'}, {'cui': 'C0032085', 'cui_str': 'Plant oil'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0052300', 'cui_str': 'Peanut Oil'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0051405', 'cui_str': 'alpha-Linolenic Acid'}, {'cui': 'C0014780', 'cui_str': 'Erythrocyte Cytoskeleton'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",251.0,0.149744,The level of α-linolenic acid in erythrocyte membranes was significantly increased in the blend oil group after the intervention (P < 0.001).,"[{'ForeName': 'Chao-Gang', 'Initials': 'CG', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Nutrition, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, 510012, P. R. China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Zhe-Qing', 'Initials': 'ZQ', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yan-Bin', 'Initials': 'YB', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'Shu-Yu', 'Initials': 'SY', 'LastName': 'Zhuo', 'Affiliation': ''}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Yu-Ming', 'Initials': 'YM', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yi-Xiang', 'Initials': 'YX', 'LastName': 'Su', 'Affiliation': ''}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': ''}]",Food & function,['10.1039/d0fo00875c']
1773,32756825,Effectiveness of a handmade shell-based substrate for the breeding of Biomphalaria glabrata under laboratory conditions.,"Efficient snail production is essential for the proper maintenance of the Schistosoma mansoni life cycle in the laboratory. In order to improve the breeding of Biomphalaria glabrata under laboratory conditions, this study aimed to demonstrate the effectiveness of a handmade shell-based substrate on the physiological performance of B. glabrata. The shells used to make the substrate were cleaned, sterilized and macerated until a powder was obtained (yield of 92.3%). B. glabrata specimens were randomly assigned to three treatment groups: negative control group (NCG) exposed to a clay-only substrate; a positive control group (PCG) containing clay, oyster flour and calcium carbonate; and the test group (TG) with the shell-based substrate and clay. B. glabrata bred in the test group showed improved growth, sexual maturity, fertility, mortality rate, and shell morphology when compared to the NCG, and similar to the PCG. Therefore, the shell-based substrate proved to be efficient and has a low cost for the breeding of B. glabrata.",2020,"B. glabrata bred in the test group showed improved growth, sexual maturity, fertility, mortality rate, and shell morphology when compared to the NCG, and similar to the PCG.",['B. glabrata specimens'],"['handmade shell-based substrate', 'negative control group (NCG) exposed to a clay-only substrate; a positive control group (PCG) containing clay, oyster flour and calcium carbonate; and the test group (TG) with the shell-based substrate and clay']","['improved growth, sexual maturity, fertility, mortality rate, and shell morphology']","[{'cui': 'C0319899', 'cui_str': 'Candida glabrata'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0030104', 'cui_str': 'Oyster'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0233891', 'cui_str': 'Finding related to maturity of sexuality'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}]",,0.016931,"B. glabrata bred in the test group showed improved growth, sexual maturity, fertility, mortality rate, and shell morphology when compared to the NCG, and similar to the PCG.","[{'ForeName': 'João Gustavo Mendes', 'Initials': 'JGM', 'LastName': 'Rodrigues', 'Affiliation': 'Departamento de Parasitologia, Instituto de Ciências Biológicas, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Maria Gabriela Sampaio', 'Initials': 'MGS', 'LastName': 'Lira', 'Affiliation': 'Departamento de Patologia, Centro de Ciências Biológicas e da Saúde, Universidade Federal do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Ranielly Araújo', 'Initials': 'RA', 'LastName': 'Nogueira', 'Affiliation': 'Departamento de Patologia, Centro de Ciências Biológicas e da Saúde, Universidade Federal do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Gleycka Cristine Carvalho', 'Initials': 'GCC', 'LastName': 'Gomes', 'Affiliation': 'Departamento de Patologia, Centro de Ciências Biológicas e da Saúde, Universidade Federal do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Irlla Correia Lima', 'Initials': 'ICL', 'LastName': 'Licá', 'Affiliation': 'Departamento de Patologia, Centro de Ciências Biológicas e da Saúde, Universidade Federal do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Davi', 'Initials': 'D', 'LastName': 'Viegas-Melo', 'Affiliation': 'Laboratório de Parasitologia Humana, Departamento de Química e Biologia, Universidade Estadual do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Teles-Reis', 'Affiliation': 'Laboratório de Parasitologia Humana, Departamento de Química e Biologia, Universidade Estadual do Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Guilherme Silva', 'Initials': 'GS', 'LastName': 'Miranda', 'Affiliation': 'Departamento de Parasitologia, Instituto de Ciências Biológicas, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Nêuton', 'Initials': 'N', 'LastName': 'Silva-Souza', 'Affiliation': 'Laboratório de Parasitologia Humana, Departamento de Química e Biologia, Universidade Estadual do Maranhão, São Luís, Maranhão, Brazil.'}]",Revista do Instituto de Medicina Tropical de Sao Paulo,['10.1590/s1678-9946202062055']
1774,32755254,Degree of Blood Pressure Control and Incident Diabetes Mellitus in Chinese Adults With Hypertension.,"Background The association between blood pressure (BP) control and incident diabetes mellitus remains unknown. We aim to investigate the association between degree of time-averaged on-treatment systolic blood pressure (SBP) control and incident diabetes mellitus in hypertensive adults. Methods and Results A total of 14 978 adults with hypertension without diabetes mellitus at baseline were included from the CSPPT (China Stroke Primary Prevention Trial). Participants were randomized double-masked to daily enalapril 10 mg and folic acid 0.8 mg or enalapril 10 mg alone. BP measurements were taken every 3 months after randomization. The primary outcome was incident diabetes mellitus, defined as physician-diagnosed diabetes mellitus, or use of glucose-lowering drugs during follow-up, or fasting glucose ≥126 mg/dL at the exit visit. Over a median of 4.5 years, a significantly higher risk of incident diabetes mellitus was found in participants with time-averaged on-treatment SBP 130 to <140 mm Hg (10.3% versus 7.4%; odds ratio [OR], 1.37; 95% CI, 1.15‒1.64), compared with those with SBP 120 to <130 mm Hg. Moreover, the risk of incident diabetes mellitus increased by 24% (OR, 1.24; 95% CI, 1.00‒1.53) and the incidence of regression to normal fasting glucose (<100 mg/dL) decreased by 29% (OR, 0.71; 95% CI, 0.57‒0.89) in participants with intermediate BP control (SBP/diastolic blood pressure, 130 to <140 and/or 80 to <90 mm Hg), compared with those with a tight BP control of <130/<80 mm Hg. Similar results were found when the time-averaged BP were calculated using the BP measurements during the first 6- or 24-month treatment period, or in the analysis using propensity scores. Conclusions In this non-diabetic, hypertensive population, SBP control in the range of 120 to <130 mm Hg, compared with the 130 to <140 mm Hg, was associated with a lower risk of incident diabetes mellitus.",2020,"Hg (10.3% versus 7.4%; odds ratio [OR], 1.37; 95% CI, 1.15‒1.64), compared with those with SBP 120 to <130 mm Hg.","['hypertensive adults', 'Chinese Adults With Hypertension', 'A total of 14\xa0978 adults with hypertension without diabetes mellitus at baseline were included from the CSPPT (China Stroke Primary Prevention Trial']","['time-averaged on-treatment systolic blood pressure (SBP) control', 'enalapril 10\xa0mg and folic acid 0.8\xa0mg or enalapril 10\xa0mg alone']","['BP measurements', 'incidence of regression to normal fasting glucose', 'incident diabetes mellitus, defined as physician-diagnosed diabetes mellitus, or use of glucose-lowering drugs during follow-up, or fasting glucose ≥126', 'Degree of Blood Pressure Control and Incident Diabetes Mellitus', 'blood pressure (BP) control and incident diabetes mellitus', 'risk of incident diabetes mellitus', 'time-averaged BP']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0986173', 'cui_str': 'Folic Acid 0.8 MG'}]","[{'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4301973', 'cui_str': 'Average blood pressure'}]",14978.0,0.11366,"Hg (10.3% versus 7.4%; odds ratio [OR], 1.37; 95% CI, 1.15‒1.64), compared with those with SBP 120 to <130 mm Hg.","[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Center for Kidney Disease State Key Laboratory for Organ Failure Research Division of Nephrology Nanfang HospitalSouthern Medical University Guangzhou China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'National Clinical Research Center for Kidney Disease State Key Laboratory for Organ Failure Research Division of Nephrology Nanfang HospitalSouthern Medical University Guangzhou China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology Peking University First Hospital Beijing China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology Peking University First Hospital Beijing China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Liang', 'Affiliation': 'National Clinical Research Center for Kidney Disease State Key Laboratory for Organ Failure Research Division of Nephrology Nanfang HospitalSouthern Medical University Guangzhou China.'}, {'ForeName': 'Guobao', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Center for Kidney Disease State Key Laboratory for Organ Failure Research Division of Nephrology Nanfang HospitalSouthern Medical University Guangzhou China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'National Clinical Research Center for Kidney Disease State Key Laboratory for Organ Failure Research Division of Nephrology Nanfang HospitalSouthern Medical University Guangzhou China.'}, {'ForeName': 'Chengzhang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Shenzhen Evergreen Medical Institute Shenzhen China.'}, {'ForeName': 'Binyan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Institute of Biomedicine Anhui Medical University Hefei China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Pharmacy Peking University First Hospital Beijing China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Population, Family and Reproductive Health Johns Hopkins University Bloomberg School of Public Health Baltimore MD.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huo', 'Affiliation': 'Department of Cardiology Peking University First Hospital Beijing China.'}, {'ForeName': 'Xiping', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'National Clinical Research Center for Kidney Disease State Key Laboratory for Organ Failure Research Division of Nephrology Nanfang HospitalSouthern Medical University Guangzhou China.'}, {'ForeName': 'Fan Fan', 'Initials': 'FF', 'LastName': 'Hou', 'Affiliation': 'National Clinical Research Center for Kidney Disease State Key Laboratory for Organ Failure Research Division of Nephrology Nanfang HospitalSouthern Medical University Guangzhou China.'}, {'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'National Clinical Research Center for Kidney Disease State Key Laboratory for Organ Failure Research Division of Nephrology Nanfang HospitalSouthern Medical University Guangzhou China.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.017015']
1775,32755695,Pharmacokinetics of fluoride in human adults: The effect of exercise.,"The literature is sparse in terms of the effect of exercise on the pharmacokinetics of fluoride (F) in humans. In a 4-treatment repeated measures cross-over study, we investigated F pharmacokinetics following no exercise (control) and three exercise intensity conditions (light, moderate and vigorous) in healthy adults. At a pre-experimental session, 8 participants (18-30y) residing in a non-fluoridated-area, underwent a VO 2 max  test to guide the three exercise intensities for the experimental sessions. Participants were on a F-free regime one week before and throughout the four experimental weeks. We measured urinary F excretion (UFE), maximum plasma concentration (Cmax), lag time of Cmax (Tmax), and Area Under the Curve (AUC) for plasma F concentration against time, following F ingestion then no, light, moderate and vigorous exercise. Results showed no statistically significant difference in Tmax among all sessions; whereas Cmax for moderate exercise (226.2 ng/ml) was significantly higher than for no (27.0 ng/ml; p < 0.001), light (105.6 ng/ml; p = 0.016) and vigorous (94.2 ng/ml; p = 0.008) exercise. Mean AUC over 0-90 min following F ingestion was also significantly higher in moderate exercise than for no (p < 0.001), light (p = 0.004) and vigorous (p = 0.001) exercise. Mean UFE over 0-14h was 638.8, 718.7, 574.6 and 450.5  μg for no, light, moderate and vigorous exercise, with no statistically significant differences among different sessions. In conclusion, this human experimental study suggests that moderate exercise may increase the fraction of F absorbed systemically which is therefore available to produce a biological effect. Future studies should be conducted with larger samples, different age groups and using different F doses.",2020,"Mean AUC over 0-90 min following F ingestion was also significantly higher in moderate exercise than for no (p < 0.001), light (p = 0.004) and vigorous (p = 0.001) exercise.","['healthy adults', 'human adults', 'humans']","['no exercise (control) and three exercise intensity conditions (light, moderate and vigorous', 'fluoride']","['Cmax for moderate exercise', 'urinary F excretion (UFE), maximum plasma concentration (Cmax), lag time of Cmax (Tmax), and Area Under the Curve (AUC) for plasma F concentration against time, following F ingestion then no, light, moderate and vigorous exercise', 'Mean AUC', 'Tmax', 'Mean UFE']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0384832,"Mean AUC over 0-90 min following F ingestion was also significantly higher in moderate exercise than for no (p < 0.001), light (p = 0.004) and vigorous (p = 0.001) exercise.","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Mahmood', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Liane B', 'Initials': 'LB', 'LastName': 'Azevedo', 'Affiliation': 'School of Human and Health Sciences, University of Huddersfield, Huddersfield, UK.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Maguire', 'Affiliation': 'School of Dental Sciences, Faculty of Medical Sciences, Newcastle University, Newcastle-upon-Tyne, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Buzalaf', 'Affiliation': 'Bauru Dental School, University of Sao Paulo, Brazil.'}, {'ForeName': 'Fatemeh Vida', 'Initials': 'FV', 'LastName': 'Zohoori', 'Affiliation': 'School of Health and Life Sciences, Teesside University, Middlesbrough, UK. Electronic address: v.zohoori@tees.ac.uk.'}]",Chemosphere,['10.1016/j.chemosphere.2020.127796']
1776,32744369,Clinical outcomes of topical bimatoprost for nonsegmental facial vitiligo: A preliminary study.,"BACKGROUND


Vitiligo is a common acquired pigmentary disorder. Bimatoprost ophthalmic solution was indicated in the treatment of open-angle glaucoma and eyebrow hypotrichosis. However, lid hyperpigmentation was reported as a complication.
OBJECTIVE


To study the efficacy and safety of 0.01% bimatoprost solution compared with 0.1% tacrolimus ointment in patients with nonsegmental facial vitiligo.
METHODS


Patients with more than 2 vitiliginous patches on the face were enrolled. Vitiliginous patches were randomized to receive topical 0.1% tacrolimus ointment or 0.01% bimatoprost ophthalmic solution, applied twice daily for 12 weeks. The vitiligo surface area (VSA, cm 2  ) was calculated, and the percentage of repigmentation was assessed.
RESULTS


Ten patients completed the study. At the baseline, the mean VSA was comparable between the two groups. By week 12, the VSA decreased at a statistically significant level among both groups compared to the baseline (P < .05). However, there was not a statistically significant difference between both groups. In terms of repigmentation at week 12, 20% of the patients in the bimatoprost group and 10% in the tacrolimus group achieved >50% repigmentation; the overall grading score between two groups were not different at a statistically significant level. The side effects of bimatoprost were reported as itching and burning. There were no changes in intraocular pressure in 2 patients who had lid involvement.
CONCLUSION


Topical bimatoprost solutions were safe and effective for the treatment of nonsegmental facial vitiligo with comparable results to tacrolimus ointment. It can be considered as an alternative treatment for facial vitiligo.",2020,Topical bimatoprost solutions were safe and effective for the treatment of non-segmental facial vitiligo with comparable results to tacrolimus ointment.,"['Vitiliginous patches', 'Patients with more than 2 vitiliginous patches on the face were enrolled', 'non-segmental facial vitiligo', 'patients with non-segmental facial vitiligo']","['tacrolimus ointment', 'topical bimatoprost', 'Topical bimatoprost solutions', 'bimatoprost solution', 'topical 0.1% tacrolimus ointment or 0.01% bimatoprost ophthalmic solution', 'tacrolimus', 'Bimatoprost ophthalmic solution']","['safe and effective', 'lid hyperpigmentation', 'mean VSA', 'overall grading score', 'itching and burning', 'VSA', 'efficacy and safety', 'intraocular pressure']","[{'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205122', 'cui_str': 'Segmental'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}]","[{'cui': 'C1253468', 'cui_str': 'Tacrolimus Topical Ointment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0937917', 'cui_str': 'bimatoprost'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C1237705', 'cui_str': 'bimatoprost Ophthalmic Solution [Lumigan]'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",,0.0483403,Topical bimatoprost solutions were safe and effective for the treatment of non-segmental facial vitiligo with comparable results to tacrolimus ointment.,"[{'ForeName': 'Silada', 'Initials': 'S', 'LastName': 'Kanokrungsee', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Duangrat', 'Initials': 'D', 'LastName': 'Pruettivorawongse', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Natta', 'Initials': 'N', 'LastName': 'Rajatanavin', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13648']
1777,32739320,Reduced dose posterior to prostate correlates with increased PSA progression in voxel-based analysis of 3 randomised phase 3 trials.,"PURPOSE


Reducing margins during treatment planning to decrease dose to healthy organs surrounding the prostate can risk inadequate treatment of subclinical disease. This study aimed to investigate whether lack of dose to subclinical disease is associated with increased disease progression by utilizing high-quality prostate radiotherapy clinical trial data to identify anatomically-localised regions where dose variation is associated with PSA progression (PSAP).
METHODS AND MATERIALS


Planned dose distributions for 683 patients of the 'Trial-A's name' were deformably registered onto a single exemplar computed tomography (CT) dataset. These were divided into high-risk and intermediate-risk sub-groups for analysis. Three independent voxel-based statistical tests, utilizing permutation testing, Cox regression modelling and LASSO feature selection, were applied to identify regions where dose variation was associated with PSAP. Results from the intermediate-risk 'Trial-A' sub-group were externally validated by registering dose distributions from 'Trial-B' (n=388) and 'Trial-C' (n=253) trials onto the same exemplar and repeating the tests on each of these data sets.
RESULTS


Voxel-based Cox regression revealed regions where reduced dose was correlated with increased PSA progression. Reduced dose in regions associated with coverage at the posterior prostate, in the immediate periphery of the posterior prostate and in regions corresponding to the posterior oblique beams or posterior lateral beam boundary, was associated with increased PSAP for 'Trial-A' and 'Trial-B' patients, but not for 'Trial-C' patients. Reduced dose to the seminal vesicles (SV) region was also associated with increased PSAP for 'Trial-A' intermediate-risk patients.
CONCLUSIONS


Ensuring adequate dose coverage at the posterior prostate and immediately surrounding posterior region (including the SV), where aggressive cancer spread may be occurring, may improve tumour control. It is recommended that particular care is taken when defining margins at the prostate posterior, acknowledging the trade-off between quality of life due to rectal dose and the preferences of clinicians and patients.",2020,"Reduced dose to the seminal vesicles (SV) region was also associated with increased PSAP for 'Trial-A' intermediate-risk patients.
","[""683 patients of the 'Trial-A's name' were deformably registered onto a single exemplar computed tomography (CT) dataset""]",[],['PSA progression'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]",[],"[{'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}]",,0.0428037,"Reduced dose to the seminal vesicles (SV) region was also associated with increased PSAP for 'Trial-A' intermediate-risk patients.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Marcello', 'Affiliation': 'Department of Physics, University of Western Australia, Western Australia, Australia; Department of Radiation Oncology, Sir Charles Gairdner Hospital, Western Australia, Australia. Electronic address: 20739859@student.uwa.edu.au.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Denham', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, New South Wales, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kennedy', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Western Australia, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Haworth', 'Affiliation': 'School of Physics, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Steigler', 'Affiliation': 'Prostate Cancer Trials Group, School of Medicine and Public Health, University of Newcastle, New South Wales, Australia.'}, {'ForeName': 'P B', 'Initials': 'PB', 'LastName': 'Greer', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, New South Wales, Australia; Department of Radiation Oncology, Calvary Mater Newcastle, New South Wales, Australia.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Holloway', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, New South Wales, Australia; South Western Sydney Clinical School, University of New South Wales, New South Wales, Australia; Centre for Medical Radiation Physics, University of Wollongong, New South Wales, Australia.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Dowling', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, New South Wales, Australia; CSIRO, Queensland, Australia.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Jameson', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, New South Wales, Australia; South Western Sydney Clinical School, University of New South Wales, New South Wales, Australia; Centre for Medical Radiation Physics, University of Wollongong, New South Wales, Australia; Cancer Research Team, Ingham Institute for Applied Medical Research, New South Wales, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Roach', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, New South Wales, Australia; South Western Sydney Clinical School, University of New South Wales, New South Wales, Australia; Cancer Research Team, Ingham Institute for Applied Medical Research, New South Wales, Australia.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': 'School of Surgery, University of Western Australia, Western Australia, Australia; 5D Clinics, Claremont, Western Australia, Australia; GenesisCare WA, Western Australia, Australia.'}, {'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Gulliford', 'Affiliation': 'Radiotherapy Department, University College London Hospitals NHS Foundation Trust, London, United Kingdom; Department of Medical Physics and Biomedical Engineering, University College London, London, UK.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'Academic UroOncology Unit, The Institute of Cancer Research and the Royal Marsden NHS Trust, London, United Kingdom.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, United Kingdom.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Ebert', 'Affiliation': 'Department of Physics, University of Western Australia, Western Australia, Australia; Department of Radiation Oncology, Sir Charles Gairdner Hospital, Western Australia, Australia; 5D Clinics, Claremont, Western Australia, Australia.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.07.030']
1778,32739460,The effect of moderate-intensity aerobic training on pulmonary function and estrogen receptor-alpha gene in postmenopausal women with vitamin D deficiency: A randomized control trial.,"BACKGROUND


The impact of aerobic training on pulmonary function by modulating gene expression of estrogen receptor-alpha (ERα), sex hormones and 25-hydroxy vitamin D (Vit D) in postmenopausal women (PMW) with Vit D deficiency is uncertain.
OBJECTIVE


The purpose of this study was to examine the effect of 12 weeks of moderate-intensity aerobic training on pulmonary function, ERα gene expression, serum levels of sex hormones and Vit D in PMW with Vit D deficiency.
METHODS


Twenty-nine sedentary PMW with Vit D deficiency (aged 45-65 yrs) were randomized to exercise (EX, n = 15) and control (C, n = 14) groups. The EX group performed moderate-intensity aerobic training for 12 weeks (50-60 min/day, 3 days/week at 65-70% of maximal heart rate reserve), but the C group participated in no intervention and maintain their normal lifestyle during 12 weeks. The pulmonary function parameters, ERα gene expression, serum levels of sex hormones and Vit D were measured at baseline and week-12.
RESULTS


After 12 weeks of aerobic exercise intervention, the increase in lymphocyte ERα gene expression (p = 0.005, estimate of effect size/Eta = 32.8%) and serum Vit D (p = 0.001, Eta = 54.7%) were significantly higher in the EX group compared to the C group, whereas pulmonary function parameters and sex hormones (17β-estradiol and progesterone) were not significantly different (P > 0.05).
CONCLUSIONS


The results suggested that 12 weeks of moderate-intensity aerobic training increased lymphocyte ERα gene expression as well as serum Vit D in sedentary PMW with Vit D deficiency although pulmonary function was not improved.",2020,"After 12 weeks of aerobic exercise intervention, the increase in lymphocyte ERα gene expression (p = 0.005, estimate of effect size/Eta = 32.8%) and serum Vit D (p = 0.001, Eta = 54.7%) were significantly higher in the EX group compared to the C group, whereas pulmonary function parameters and sex hormones (17β-estradiol and progesterone) were not significantly different (P > 0.05).
","['postmenopausal women with vitamin D deficiency', 'postmenopausal women (PMW) with Vit D deficiency', 'Twenty-nine sedentary PMW with Vit D deficiency (aged 45-65 yrs']","['aerobic exercise intervention', 'aerobic training', 'C group participated in no intervention and maintain their normal lifestyle', 'exercise (EX', 'moderate-intensity aerobic training']","['pulmonary function, ERα gene expression, serum levels of sex hormones and Vit D', 'estrogen receptor-alpha (ERα), sex hormones and 25-hydroxy vitamin D (Vit D', 'pulmonary function parameters and sex hormones (17β-estradiol and progesterone', 'lymphocyte ERα gene expression', 'serum Vit D', 'pulmonary function and estrogen receptor-alpha gene', 'pulmonary function parameters, ERα gene expression, serum levels of sex hormones and Vit D']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0665341', 'cui_str': 'Estrogen Receptors alpha'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]",29.0,0.0296952,"After 12 weeks of aerobic exercise intervention, the increase in lymphocyte ERα gene expression (p = 0.005, estimate of effect size/Eta = 32.8%) and serum Vit D (p = 0.001, Eta = 54.7%) were significantly higher in the EX group compared to the C group, whereas pulmonary function parameters and sex hormones (17β-estradiol and progesterone) were not significantly different (P > 0.05).
","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Malandish', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran. Electronic address: malandish@gmail.com.'}, {'ForeName': 'Bakhtyar', 'Initials': 'B', 'LastName': 'Tartibian', 'Affiliation': ""Department of Sport Injuries & Corrective Exercises, Faculty of Physical Education & Sport Sciences, Allameh Tabataba'i University, Tehran, Iran. Electronic address: ba.tartibian@gmail.com.""}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Rahmati', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: rahmati_bio@yahoo.com.'}, {'ForeName': 'Roghaiyeh', 'Initials': 'R', 'LastName': 'Afsargharehbagh', 'Affiliation': 'Department of Interventional Cardiology, Shohada Hospital, Urmia University of Medical Sciences, Urmia, Iran. Electronic address: r.afsargarebag@gmail.com.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Sheikhlou', 'Affiliation': 'Department of Exercise Physiology, Faculty of Sport Sciences, Urmia University, Urmia, Iran. Electronic address: Z.sheikhlou@gmail.com.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103510']
1779,32739493,Patient-centered and efficacious advance care planning in cancer: Protocol and key design considerations for the PEACe-compare trial.,"BACKGROUND


Failure to deliver care near the end of life that reflects the needs, values and preferences of patients with advanced cancer remains a major shortcoming of our cancer care delivery system.
METHODS


A mixed-methods comparative effectiveness trial of in-person advance care planning (ACP) discussions versus web-based ACP is currently underway at oncology practices in Western Pennsylvania. Patients with advanced cancer and their caregivers are invited to enroll. Participants are randomized to either (1) in-person ACP discussions via face-to-face visits with a nurse facilitator following the Respecting Choices® Conversation Guide or (2) web-based ACP using the PREPARE for your care™ web-based ACP tool. The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs. Factors influencing ACP effectiveness are assessed via in-depth interviews with patients, caregivers and clinicians.
DISCUSSION


This trial will provide new and much-needed empirical evidence about two patient-facing ACP approaches that successfully overcome limitations of traditional written advance directives but entail very different investments of time and resources. It is innovative in using mixed methods to evaluate not only the comparative effectiveness of these approaches, but also the contexts and mechanisms influencing effectiveness. Data from this study will inform clinicians, payers and health systems seeking to adopt and scale the most effective and efficient ACP strategy in real-world oncology settings.",2020,"The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs.","['Patients with advanced cancer and their caregivers are invited to enroll', 'patients with advanced cancer']","['person advance care planning (ACP) discussions versus web-based ACP', 'person ACP discussions via face-to-face visits with a nurse facilitator following the Respecting Choices® Conversation Guide or (2) web-based ACP using the PREPARE for your care™ web-based ACP tool']","['patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs', 'ACP effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0600371', 'cui_str': 'Advance care planning'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.133077,"The trial compares the effect of these two interventions on patient and family caregiver outcomes (engagement in ACP, primary outcome; ACP discussions; advance directive (AD) completion; quality of end-of-life (EOL) care; EOL goal attainment; caregiver psychological symptoms; healthcare utilization at EOL) and assesses implementation costs.","[{'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Resick', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: jmr58@pitt.edu.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Arnold', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: rabob@pitt.edu.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Sudore', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California, San Francisco, USA; San Francisco Veterans Affairs Health Care System, SFVAMC 4150 Clement Street, #151R, San Francisco, CA 94121, USA. Electronic address: Rebecca.Sudore@ucsf.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farrell', 'Affiliation': 'People Designs, Inc., 1304 Broad Street, Durham, NC 27705, USA. Electronic address: dfarrell@peopledesigns.com.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Belin', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: belin@pitt.edu.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Althouse', 'Affiliation': 'Center for Research on Health Care Data Center, University of Pittsburgh School of Medicine, 200 Meyran Avenue, Suite 300, Pittsburgh, PA 15213, USA. Electronic address: ada62@pitt.edu.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Ferrell', 'Affiliation': 'Division of Nursing Research and Education, Department of Population Sciences, City of Hope Medical Center, 1500 Duarte Road, Duarte, CA 91010, USA. Electronic address: BFerrell@coh.org.'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Hammes', 'Affiliation': 'Respecting Choices, A Division of C-TAC Innovations, PO Box 258, Oregon, WI 53575-0258, USA. Electronic address: bhammes@respectingchoices.org.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Chu', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology and Cancer Therapeutics Program, UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: chue2@upmc.edu.'}, {'ForeName': 'Douglas B', 'Initials': 'DB', 'LastName': 'White', 'Affiliation': 'University of Pittsburgh, School of Medicine, Department of Critical Care Medicine, Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Program on Ethics and Decision Making, 600 Scaife Hall, 3550 Terrace Street, Pittsburgh, PA 15213, USA. Electronic address: douglas.white@pitt.edu.'}, {'ForeName': 'Kimberly J', 'Initials': 'KJ', 'LastName': 'Rak', 'Affiliation': 'University of Pittsburgh, School of Medicine, Department of Critical Care Medicine, Clinical Research, Investigation, and Systems Modeling of Acute Illness Center, Program on Ethics and Decision Making, 3520 Fifth Ave, Suite100, Pittsburgh, PA 15213, USA. Electronic address: kjr8@pitt.edu.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Schenker', 'Affiliation': 'Palliative Research Center (PaRC), Section of Palliative Care and Medical Ethics, Division of General Internal Medicine, University of Pittsburgh, 230 McKee Place, Pittsburgh, PA, 15213, USA. Electronic address: yas28@pitt.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106071']
1780,32739494,Cancer history and risk factors in healthy older people enrolling in the ASPREE clinical trial.,"BACKGROUND


Cancer is a leading cause of death globally. Given the elevated risk of cancer with age and an ageing population, it is important to understand the changing burden of cancer in older populations. The ASPirin in Reducing Events in the Elderly (ASPREE) study randomised healthy older individuals to 100 mg aspirin or placebo, with clinical outcomes and disability-free survival endpoints. Detailed baseline data provides a rare opportunity to explore cancer burden in a uniquely healthy older population.
METHODS


At study enrolment (2010-2014), self-reported personal cancer history, cancer type and cancer risk factor data were sought from 19,114 participants (Australia, n = 16,703; U.S., n = 2411). Eligible participants were healthy, free of major diseases and expected to survive 5 years.
RESULTS


Nearly 20% of enrolling ASPREE participants reported a prior cancer diagnosis; 18% of women and 22% of men, with women diagnosed younger (16% vs 6% of diagnoses <50 years). Cancer prevalence increased with age. Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants. Cancer history prevalence was not associated with contemporary common risk factors nor previous aspirin use, but was associated with poor health ratings in men. Blood and breast cancer history were more common with past aspirin use.
CONCLUSIONS


Personal cancer history in healthy older ASPREE participants was as expected for the most common cancer types in the respective populations, but was not necessarily aligned with known risk factors. We attribute this to survivor bias, likely driven by entry criteria.
TRIAL REGISTRATION


International Standard Randomised Controlled Trial Number Register (ISRCTN83772183) and clinicaltrials.gov (NCT01038583).",2020,Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants.,"['healthy older individuals to 100\u202fmg', 'Eligible participants were healthy, free of major diseases and expected to survive 5\u202fyears', 'healthy older ASPREE participants', 'healthy older people enrolling', 'At study enrolment (2010-2014), self-reported personal cancer history, cancer type and cancer risk factor data were sought from 19,114 participants (Australia, n\u202f=\u202f16,703; U.S., n\u202f=\u202f2411', 'uniquely healthy older population']","['ASPirin', 'aspirin or placebo']","['Cancer history and risk factors', 'Prevalence of prostate and breast cancer history', 'Cancer prevalence']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]",19114.0,0.463069,Prevalence of prostate and breast cancer history were higher in U.S. participants; melanoma and colorectal cancer were higher in Australian participants.,"[{'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Orchard', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Suzanne.orchard@monash.edu.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Jessica.lockery@monash.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gibbs', 'Affiliation': 'The Walter & Eliza Hall Institute of Medical Research, University of Melbourne,1G Royal Parade, Parkville, Victoria 3052, Australia. Electronic address: Peter.gibbs@petermac.org.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Polekhina', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Galhina.polekhina@monash.edu.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Rory.wolfe@monash.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zalcberg', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: John.zalcberg@monash.edu.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Haydon', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Andrew.haydon@monash.edu.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: John.mcneil@monash.edu.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, 17 Liverpool St (Private Bag 23), Hobart 7000, Tasmania, Australia. Electronic address: Mark.nelson@utas.edu.au.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'School of Public Health, Curtin University, Kent Street, Bentley, Perth 6102, Western Australia, Australia. Electronic address: Christpher.reid@curtin.edu.au.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Kirpach', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute (HHRI), 701 Park Avenue, Suite PP7.700, Minneapolis 55415, Minnesota, USA. Electronic address: bkirpach@bermancenter.org.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute (HHRI), 701 Park Avenue, Suite PP7.700, Minneapolis 55415, Minnesota, USA; Division of Geriatrics, Department of Medicine, Hennepin Healthcare and University of Minnesota, East River Parkway, Minneapolis 55455, Minnesota, USA. Electronic address: AMurray@bermancenter.org.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology & Preventive Medicine, Monash University, 99 Commercial Road, Melbourne, Victoria 3004, Australia. Electronic address: Robyn.woods@monash.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Contemporary clinical trials,['10.1016/j.cct.2020.106095']
1781,32740293,Hemodynamic responses of resistance exercise performed with repetitions to failure and not to failure in adults with hypertension.,"OBJECTIVE


To evaluate and compare the hemodynamic responses of resistance exercise (RE) performed with repetitions to failure vs. not to failure in individuals with hypertension.
METHODS


Twenty participants were randomly allocated to perform three experimental sessions: a RE session performed with repetitions to failure (RF); a RE session performed with repetitions not to failure (NRF); and a non-exercise control session (Con). RE sessions were composed of four sets of 10 repetitions in four exercises involving large muscle groups. To ensure that the sets could be performed with RF or NRF, intensities corresponding to 75% and 50% of one-repetition maximum test were adopted in RF and NRF sessions, respectively. The Con was performed in seated rest. Blood pressure and rate-pressure product were measured before, during and after the experimental sessions for 1 h.
RESULTS


SBP and DBP decreased after NRF compared with Con (systolic post 1 h: -7.7 ± 1.1 mmHg, P < 0.001; diastolic post 1 h: -4.2 ± 0.7 mmHg, P = 0.001), and after RF compared with Con (systolic post 1 h: -8.2 ± 1.3 mmHg, P < 0.001; diastolic post 1 h: -7.4 ± 1.4 mmHg, P < 0.001). No significant difference was found in blood pressure between RF and NRF sessions after 1 h. Rate-pressure product was lower during NRF compared with RF (P = 0.001), suggesting a higher cardiovascular demand during the RF session.
CONCLUSION


The RF and NRF sessions are equally effective to promote post-exercise hypotension. In addition, NRF session can reduce cardiac demand during the exercise and should be recommended in adults with hypertension.",2020,"No significant difference was found in blood pressure between RF and NRF sessions after 1 h. Rate-pressure product was lower during NRF compared with RF (P = 0.001), suggesting a higher cardiovascular demand during the RF session.
","['Twenty participants', 'individuals with hypertension', 'adults with hypertension']","['resistance exercise (RE', 'NRF session', 'RE session performed with repetitions to failure (RF); a RE session performed with repetitions not to failure (NRF); and a non-exercise control session (Con', 'resistance exercise']","['Rate-pressure product', 'blood pressure', 'SBP and DBP', 'Blood pressure and rate-pressure product']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",20.0,0.0252005,"No significant difference was found in blood pressure between RF and NRF sessions after 1 h. Rate-pressure product was lower during NRF compared with RF (P = 0.001), suggesting a higher cardiovascular demand during the RF session.
","[{'ForeName': 'Lucas B', 'Initials': 'LB', 'LastName': 'Domingues', 'Affiliation': 'Postgraduate Program in Cardiology, Universidade Federal do Rio Grande do Sul.'}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Cadore', 'Affiliation': 'Sports and Exercise Training Study Group, Hospital de Clínicas de Porto Alegre.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ferrari', 'Affiliation': 'Postgraduate Program in Cardiology, Universidade Federal do Rio Grande do Sul.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000478']
1782,32741099,"Retzius-sparing robot-assisted radical prostatectomy improves early recovery of urinary continence: a randomized, controlled, single-blind trial with a 1-year follow-up.","OBJECTIVE


To evaluate the impact of Retzius-sparing robot-assisted radical prostatectomy (posterior approach) on early recovery of urinary continence (UC) compared to the conventional approach (anterior approach) for the treatment of clinically localized prostate cancer (PCa).
METHODS


A total of 110 consecutive patients with clinically localized PCa were prospectively randomized in a 1:1 ratio to an anterior group (n = 55) or a posterior group (n = 55). The primary outcome was immediate UC, defined as freedom from any pad use within 1 week after removal of the urinary catheter. The UC rate following surgery was also calculated with Kaplan-Meier curves, and the log-rank test was used for statistical comparison. Intra-operative outcomes, pathological data and oncological outcomes, including positive surgical margin (PSM) status and biochemical recurrence-free survival (BCRFS), were also compared between the two groups. The comparison of the two approaches was also analysed in subgroups after risk stratification.
RESULTS


Of the patients who underwent the posterior approach, 69.1% achieved immediate UC compared with 30.9% in the anterior group (relative risk 2.24, 95% confidence interval [CI] 1.48-3.51; P = 0.000). The relative Kaplan-Meier curves for UC during the 12-month follow-up revealed statistically better recovery in the posterior group when compared with the anterior group (hazard ratio [HR] 1.51, 95% CI 1.01-2.24; log-rank P = 0.007). No statistically significant differences were observed between the groups regarding complications (P = 0.399), PSM status (P = 0.225) or BCRFS (HR 4.80, 95% CI 0.97-23.78; log-rank P = 0.111). In sub-analyses, no significant difference between the two approaches with regard to UC recovery in patients with high-risk PCa was observed (HR 1.26, 95% CI 0.63-2.51; log-rank P = 0.415).
CONCLUSIONS


The Retzius-sparing approach significantly improved early recovery of UC compared to the conventional approach. Further prospective studies are needed to confirm the benefits of the Retzius-sparing approach for clinically localized PCa, especially for high-risk cases.",2020,"The relative Kaplan-Meier curves regarding UC during 12-month follow-up revealed statistically better recovery of posterior approach when compared with anterior approach (HR = 1.51, 95% CI: 1.01 - 2.24, log-rank p = 0.007).","['clinically localized prostate cancer (PCa', '110 consecutive patients with clinically localized PCa']","['Retzius-sparing robot-assisted radical prostatectomy', 'Retzius-sparing robot-assisted radical prostatectomy (posterior approach', 'conventional approach (anterior approach']","['Intraoperative outcomes, pathologic data and oncologic outcome including positive surgical margin (PSM) and biochemical recurrence-free survival (BCRFS', 'PSM', 'urinary continence', 'immediate UC defined as freedom from any pad use within 1 week after removal of urinary catheter', 'immediate UC', 'UC rate', 'early recovery of UC', 'BCRFS', 'continence recovery', 'early recovery of urinary continence (UC']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392752', 'cui_str': 'Localized'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0542565', 'cui_str': 'Bladder control'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0194049', 'cui_str': 'Removal of urinary drainage device'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",110.0,0.109697,"The relative Kaplan-Meier curves regarding UC during 12-month follow-up revealed statistically better recovery of posterior approach when compared with anterior approach (HR = 1.51, 95% CI: 1.01 - 2.24, log-rank p = 0.007).","[{'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Qiu', 'Affiliation': 'Department of Urology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Youjian', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Mengxia', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Linfeng', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Urology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Suhan', 'Initials': 'S', 'LastName': 'Guo', 'Affiliation': 'School of Artificial Intelligence, Nanjing University, Nanjing, China.'}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Marra', 'Affiliation': 'Department of Urology, San Giovanni Battista Hospital, Città della Salute e della Scienza, University of Turin, Turin, Italy.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Elliot Rosenberg', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Haoxin', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Department of Urology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Xiaogong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Urology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Hongqian', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Department of Urology, Affiliated Drum Tower Hospital, Medical School of Nanjing University, Nanjing, China.'}]",BJU international,['10.1111/bju.15195']
1783,32738955,"Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial.","BACKGROUND


Treatment of dysplastic Barrett's oesophagus prevents progression to adenocarcinoma; however, the optimal diagnostic strategy for Barrett's oesophagus is unclear. The Cytosponge-trefoil factor 3 (TFF3) is a non-endoscopic test for Barrett's oesophagus. The aim of this study was to investigate whether offering this test to patients on medication for gastro-oesophageal reflux would increase the detection of Barrett's oesophagus compared with standard management.
METHODS


This multicentre, pragmatic, randomised controlled trial was done in 109 socio-demographically diverse general practice clinics in England. Randomisation was done both at the general practice clinic level (cluster randomisation) and at the individual patient level, and the results for each type of randomisation were analysed separately before being combined. Patients were eligible if they were aged 50 years or older, had been taking acid-suppressants for symptoms of gastro-oesophageal reflux for more than 6 months, and had not undergone an endoscopy procedure within the past 5 years. General practice clinics were selected by the local clinical research network and invited to participate in the trial. For cluster randomisation, clinics were randomly assigned (1:1) by the trial statistician using a computer-generated randomisation sequence; for individual patient-level randomisation, patients were randomly assigned (1:1) by the general practice clinics using a centrally prepared computer-generated randomisation sequence. After randomisation, participants received either standard management of gastro-oesophageal reflux (usual care group), in which participants only received an endoscopy if required by their general practitioner, or usual care plus an offer of the Cytosponge-TFF3 procedure, with a subsequent endoscopy if the procedure identified TFF3-positive cells (intervention group). The primary outcome was the diagnosis of Barrett's oesophagus at 12 months after enrolment, expressed as a rate per 1000 person-years, in all participants in the intervention group (regardless of whether they had accepted the offer of the Cytosponge-TFF3 procedure) compared with all participants in the usual care group. Analyses were intention-to-treat. The trial is registered with the ISRCTN registry, ISRCTN68382401, and is completed.
FINDINGS


Between March 20, 2017, and March 21, 2019, 113 general practice clinics were enrolled, but four clinics dropped out shortly after randomisation. Using an automated search of the electronic prescribing records of the remaining 109 clinics, we identified 13 657 eligible patients who were sent an introductory letter with 14 days to opt out. 13 514 of these patients were randomly assigned (per practice or at the individual patient level) to the usual care group (n=6531) or the intervention group (n=6983). Following randomisation, 149 (2%) of 6983 participants in the intervention group and 143 (2%) of 6531 participants in the usual care group, on further scrutiny, did not meet all eligibility criteria or withdrew from the study. Of the remaining 6834 participants in the intervention group, 2679 (39%) expressed an interest in undergoing the Cytosponge-TFF3 procedure. Of these, 1750 (65%) met all of the eligibility criteria on telephone screening and underwent the procedure. Most of these participants (1654 [95%]; median age 69 years) swallowed the Cytosponge successfully and produced a sample. 231 (3%) of 6834 participants had a positive Cytosponge-TFF3 result and were referred for an endoscopy. Patients who declined the offer of the Cytosponge-TFF3 procedure and all participants in the usual care group only had an endoscopy if deemed necessary by their general practitioner. During an average of 12 months of follow-up, 140 (2%) of 6834 participants in the intervention group and 13 (<1%) of 6388 participants in the usual care group were diagnosed with Barrett's oesophagus (absolute difference 18·3 per 1000 person-years [95% CI 14·8-21·8]; rate ratio adjusted for cluster randomisation 10·6 [95% CI 6·0-18·8], p<0·0001). Nine (<1%) of 6834 participants were diagnosed with dysplastic Barrett's oesophagus (n=4) or stage I oesophago-gastric cancer (n=5) in the intervention group, whereas no participants were diagnosed with dysplastic Barrett's oesophagus or stage I gastro-oesophageal junction cancer in the usual care group. Among 1654 participants in the intervention group who swallowed the Cytosponge device successfully, 221 (13%) underwent endoscopy after testing positive for TFF3 and 131 (8%, corresponding to 59% of those having an endoscopy) were diagnosed with Barrett's oesophagus or cancer. One patient had a detachment of the Cytosponge from the thread requiring endoscopic removal, and the most common side-effect was a sore throat in 63 (4%) of 1654 participants.
INTERPRETATION


In patients with gastro-oesophageal reflux, the offer of Cytosponge-TFF3 testing results in improved detection of Barrett's oesophagus. Cytosponge-TFF3 testing could also lead to the diagnosis of treatable dysplasia and early cancer. This strategy will lead to additional endoscopies with some false positive results.
FUNDING


Cancer Research UK, National Institute for Health Research, the UK National Health Service, Medtronic, and the Medical Research Council.",2020,The Cytosponge-trefoil factor 3 (TFF3) is a non-endoscopic test for Barrett's oesophagus.,"['Patients were eligible if they were aged 50 years or older, had been taking acid-suppressants for symptoms of gastro-oesophageal reflux for more than 6 months, and had not undergone an endoscopy procedure within the past 5 years', 'Patients who declined the offer of the Cytosponge-TFF3 procedure and all participants in the usual care group only had an endoscopy if deemed necessary by their general practitioner', 'remaining 109 clinics, we identified 13\u2008657 eligible patients who were sent an introductory letter with 14 days to opt out', '6983 participants in the intervention group and 143 (2%) of 6531 participants in the usual care group, on further scrutiny, did not meet all eligibility criteria or withdrew from the study', 'Between March 20, 2017, and March 21, 2019, 113 general practice clinics were enrolled, but four clinics dropped out shortly after randomisation', ""1654 participants in the intervention group who swallowed the Cytosponge device successfully, 221 (13%) underwent endoscopy after testing positive for TFF3 and 131 (8%, corresponding to 59% of those having an endoscopy) were diagnosed with Barrett's oesophagus or cancer"", ""6834 participants were diagnosed with dysplastic Barrett's oesophagus (n=4) or stage"", '231 (3%) of 6834 participants had a positive Cytosponge-TFF3 result and were referred for an endoscopy', '109 socio-demographically diverse general practice clinics in England', 'patients with gastro-oesophageal reflux']","[""Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus"", 'standard management of gastro-oesophageal reflux (usual care group), in which participants only received an endoscopy if required by their general practitioner, or usual care plus an offer of the Cytosponge-TFF3 procedure, with a subsequent endoscopy if the procedure identified TFF3-positive cells (intervention group']","[""diagnosis of Barrett's oesophagus"", ""diagnosed with dysplastic Barrett's oesophagus or stage I gastro-oesophageal junction cancer"", ""diagnosed with Barrett's oesophagus""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0660409', 'cui_str': 'TFF3 protein, human'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0660409', 'cui_str': 'TFF3 protein, human'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004763', 'cui_str': ""Barrett's esophagus""}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",6834.0,0.132661,The Cytosponge-trefoil factor 3 (TFF3) is a non-endoscopic test for Barrett's oesophagus.,"[{'ForeName': 'Rebecca C', 'Initials': 'RC', 'LastName': 'Fitzgerald', 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, UK. Electronic address: rcf29@mrc-cu.cam.ac.uk.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'di Pietro', 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""O'Donovan"", 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Maroni', 'Affiliation': ""Cancer Research UK and King's College London Cancer Prevention Trials Unit, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Muldrew', 'Affiliation': ""Cancer Research UK and King's College London Cancer Prevention Trials Unit, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Debiram-Beecham', 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Gehrung', 'Affiliation': 'Cancer Research UK Cambridge Institute, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Offman', 'Affiliation': ""Cancer Prevention Group, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Tripathi', 'Affiliation': 'MRC Cancer Unit, Hutchison-MRC Research Centre, University of Cambridge, Cambridge, UK; Cambridge University Hospitals National Health Service Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Samuel G', 'Initials': 'SG', 'LastName': 'Smith', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Aigret', 'Affiliation': ""Cancer Research UK and King's College London Cancer Prevention Trials Unit, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Walter', 'Affiliation': 'The Primary Unit, Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Rubin', 'Affiliation': 'Institute of Population Health Sciences, Newcastle University, Sir James Spence Institute, Royal Victoria Infirmary, Newcastle upon Tyne, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sasieni', 'Affiliation': ""Cancer Research UK and King's College London Cancer Prevention Trials Unit, School of Cancer and Pharmaceutical Sciences, King's College London, London, UK.""}]","Lancet (London, England)",['10.1016/S0140-6736(20)31099-0']
1784,32747522,Effect of fremanezumab on quality of life and productivity in patients with chronic migraine.,"OBJECTIVE


To evaluate fremanezumab quarterly or monthly vs placebo on health-related quality of life, health status, patients' global impression of change, and productivity in patients with chronic migraine (CM).
METHODS


HALO CM was a double-blind, placebo-controlled trial in patients with CM. Patients were randomized 1:1:1 to treatment with fremanezumab quarterly (675 mg at baseline, placebo at weeks 4 and 8), fremanezumab monthly (225 mg at baseline, weeks 4 and 8), or placebo. This article assessed the effect of treatment with fremanezumab on health-related quality of life and productivity using the following prespecified assessments: the Migraine-Specific Quality of Life (MSQoL) questionnaire at baseline and weeks 4, 8, and 12; Patient Global Impression of Change (PGIC) questionnaire at weeks 4, 8, and 12; and EuroQoL 5-dimension, 5-response level (EQ-5D-5L) questionnaire and Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire at baseline and week 12.
RESULTS


The full analysis set included 1,121 patients: 375 patients with quarterly dosing, 375 with monthly dosing, and 371 with placebo. Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all,  p  < 0.05) to week 12. At week 12, fremanezumab also showed significant improvements in EQ-5D-5L visual analog scale ( p  < 0.05) and PGIC scores ( p  < 0.0001) as well as significant reductions from baseline in WPAI:GH scores ( p  < 0.01) and presenteeism (impairment while working;  p  < 0.05) vs placebo.
CONCLUSIONS


Fremanezumab quarterly or monthly was associated with improvement over placebo in migraine-specific quality of life, overall health status, patients' global impression of change with treatment, and productivity in patients with CM.
CLINICALTRIALSGOV IDENTIFIER


NCT02621931.
CLASSIFICATION OF EVIDENCE


This study provides Class II evidence that in patients with CM, treatment with fremanezumab quarterly or monthly is associated with improvements in health-related quality of life and productivity.",2020,"Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all,  p  < 0.05) to week 12.","['patients with chronic migraine (CM', 'Patients With Chronic Migraine', '1121 patients: 375 patients with quarterly dosing, 375 with monthly dosing, and 371 with', 'patients with CM']","['fremanezumab', 'fremanezumab quarterly (675 mg at baseline, placebo', 'Fremanezumab', 'fremanezumab quarterly or monthly vs placebo', 'placebo']","[""health-related quality of life, health status, patients' global impression of change, and productivity"", 'Quality of Life and Productivity', 'health-related quality of life and productivity', 'migraine-specific quality of life, overall health status', 'EuroQoL 5-dimension, 5-response level (EQ-5D-5L) questionnaire and Work Productivity and Activity Impairment: General Health (WPAI:GH) questionnaire', 'Migraine-Specific Quality of Life (MSQoL) questionnaire', 'PGIC scores', 'WPAI:GH scores', 'Patient Global Impression of Change (PGIC) questionnaire', 'EQ-5D-5L visual analog scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960870', 'cui_str': 'Transformed migraine'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C4549503', 'cui_str': 'fremanezumab'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C4517854', 'cui_str': '675'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",1121.0,0.33054,"Fremanezumab quarterly and monthly was associated with significant improvements over placebo in change from baseline mean scores in MSQoL domains (all,  p  < 0.05) to week 12.","[{'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA. Richard.Lipton@einstein.yu.edu.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Cohen', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Sanjay K', 'Initials': 'SK', 'LastName': 'Gandhi', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Ronghua', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Paul P', 'Initials': 'PP', 'LastName': 'Yeung', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}, {'ForeName': 'Dawn C', 'Initials': 'DC', 'LastName': 'Buse', 'Affiliation': 'From the Montefiore Headache Center (R.B.L.), Albert Einstein College of Medicine (R.B.L., D.C.B.), Bronx, NY; and Teva Pharmaceutical Industries Ltd. (J.M.C., S.K.G., R.Y., P.P.Y.), West Chester, PA.'}]",Neurology,['10.1212/WNL.0000000000010000']
1785,32747544,An objective evaluation of the beholder's response to abstract and figurative art based on construal level theory.,"Does abstract art evoke a different cognitive state than figurative art? To address this question empirically, we bridged art theory and cognitive research and designed an experiment leveraging construal level theory (CLT). CLT is based on experimental data showing that psychologically distant events (i.e., occurring farther away in space or time) are represented more abstractly than closer events. We measured construal level elicited by abstract vs. representational art and asked subjects to assign abstract/representational paintings by the same artist to a situation that was temporally/spatially near or distant. Across three experiments, we found that abstract paintings were assigned to the distant situation significantly more often than representational paintings, indicating that abstract art was evocative of greater psychological distance. Our data demonstrate that different levels of artistic abstraction evoke different levels of mental abstraction and suggest that CLT provides an empirical approach to the analysis of cognitive states evoked by different levels of artistic abstraction.",2020,"Across three experiments, we found that abstract paintings were assigned to the distant situation significantly more often than representational paintings, indicating that abstract art was evocative of greater psychological distance.",[],['CLT'],[],[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}]",[],,0.0375673,"Across three experiments, we found that abstract paintings were assigned to the distant situation significantly more often than representational paintings, indicating that abstract art was evocative of greater psychological distance.","[{'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Durkin', 'Affiliation': 'Department of Psychology, Columbia University, New York, NY 10027.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Hartnett', 'Affiliation': 'Department of Psychology, Columbia University, New York, NY 10027.'}, {'ForeName': 'Daphna', 'Initials': 'D', 'LastName': 'Shohamy', 'Affiliation': 'Department of Psychology, Columbia University, New York, NY 10027; ds2619@columbia.edu erk5@columbia.edu.'}, {'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Kandel', 'Affiliation': 'Mortimer B. Zuckerman Mind Brain Behavior Institute, Columbia University, New York, NY 10027; ds2619@columbia.edu erk5@columbia.edu.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.2001772117']
1786,32745085,"Anopheles bionomics, insecticide resistance and malaria transmission in southwest Burkina Faso: A pre-intervention study.","BACKGROUND


Twenty-seven villages were selected in southwest Burkina Faso to implement new vector control strategies in addition to long lasting insecticidal nets (LLINs) through a Randomized Controlled Trial (RCT). We conducted entomological surveys in the villages during the dry cold season (January 2017), dry hot season (March 2017) and rainy season (June 2017) to describe malaria vectors bionomics, insecticide resistance and transmission prior to this trial.
METHODS


We carried out hourly catches (from 17:00 to 09:00) inside and outside 4 houses in each village using the Human Landing Catch technique. Mosquitoes were identified using morphological taxonomic keys. Specimens belonging to the Anopheles gambiae complex and Anopheles funestus group were identified using molecular techniques as well as detection of Plasmodium falciparum infection and insecticide resistance target-site mutations.
RESULTS


Eight Anopheles species were detected in the area. Anopheles funestus s.s was the main vector during the dry cold season. It was replaced by Anopheles coluzzii during the dry hot season whereas An. coluzzii and An. gambiae s.s. were the dominant species during the rainy season. Species composition of the Anopheles population varied significantly among seasons. All insecticide resistance mechanisms (kdr-w, kdr-e and ace-1 target site mutations) investigated were found in each members of the An. gambiae complex but at different frequencies. We observed early and late biting phenotypes in the main malaria vector species. Entomological inoculation rates were 2.61, 2.67 and 11.25 infected bites per human per month during dry cold season, dry hot season and rainy season, respectively.
CONCLUSION


The entomological indicators of malaria transmission were high despite the universal coverage with LLINs. We detected early and late biting phenotypes in the main malaria vector species as well as physiological insecticide resistance mechanisms. These data will be used to evaluate the impact of complementary tools to LLINs in an upcoming RCT.",2020,"Entomological inoculation rates were 2.61, 2.67 and 11.25 infected bites per human per month during dry cold season, dry hot season and rainy season, respectively.
","['Twenty-seven villages', 'villages during the dry cold season (January 2017), dry hot season (March 2017) and rainy season (June 2017) to describe malaria vectors bionomics, insecticide resistance and transmission prior to this trial', 'southwest Burkina Faso']",[],['Entomological inoculation rates'],"[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0005550', 'cui_str': 'Bionomics'}, {'cui': 'C0021575', 'cui_str': 'Insecticide Resistance'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}]",[],"[{'cui': 'C0042196', 'cui_str': 'Vaccination'}]",27.0,0.022626,"Entomological inoculation rates were 2.61, 2.67 and 11.25 infected bites per human per month during dry cold season, dry hot season and rainy season, respectively.
","[{'ForeName': 'Dieudonné Diloma', 'Initials': 'DD', 'LastName': 'Soma', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Barnabas Mahugnon', 'Initials': 'BM', 'LastName': 'Zogo', 'Affiliation': 'MIVEGEC, Université de Montpellier, CNRS, IRD, Montpellier, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Somé', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': ""Bertin N'Cho"", 'Initials': 'BN', 'LastName': 'Tchiekoi', 'Affiliation': 'MIVEGEC, Université de Montpellier, CNRS, IRD, Montpellier, France.'}, {'ForeName': 'Domonbabele François de Sales', 'Initials': 'DFS', 'LastName': 'Hien', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Hermann Sié', 'Initials': 'HS', 'LastName': 'Pooda', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Sanata', 'Initials': 'S', 'LastName': 'Coulibaly', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Jacques Edounou', 'Initials': 'JE', 'LastName': 'Gnambani', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ouari', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Mouline', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Amal', 'Initials': 'A', 'LastName': 'Dahounto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Georges Anicet', 'Initials': 'GA', 'LastName': 'Ouédraogo', 'Affiliation': 'Université Nazi Boni, Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Fournet', 'Affiliation': 'MIVEGEC, Université de Montpellier, CNRS, IRD, Montpellier, France.'}, {'ForeName': 'Alphonsine Amanan', 'Initials': 'AA', 'LastName': 'Koffi', 'Affiliation': ""Institut Pierre Richet (IPR), Bouaké, Côte d'Ivoire.""}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Pennetier', 'Affiliation': 'MIVEGEC, Université de Montpellier, CNRS, IRD, Montpellier, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Moiroux', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}, {'ForeName': 'Roch Kounbobr', 'Initials': 'RK', 'LastName': 'Dabiré', 'Affiliation': 'Institut de Recherche en Sciences de la Santé (IRSS), Bobo-Dioulasso, Burkina Faso.'}]",PloS one,['10.1371/journal.pone.0236920']
1787,32745092,Aspirin versus low-molecular-weight heparin for venous thromboembolism prophylaxis in orthopaedic trauma patients: A patient-centered randomized controlled trial.,"BACKGROUND


Emerging evidence suggests aspirin may be an effective venous thromboembolism (VTE) prophylaxis for orthopaedic trauma patients, with fewer bleeding complications. We used a patient-centered weighted composite outcome to globally evaluate aspirin versus low-molecular-weight heparin (LMWH) for VTE prevention in fracture patients.
METHODS


We conducted an open-label randomized clinical trial of adult patients admitted to an academic trauma center with an operative extremity fracture, or a pelvis or acetabular fracture. Patients were randomized to receive LMWH (enoxaparin 30-mg) twice daily (n = 164) or aspirin 81-mg twice daily (n = 165). The primary outcome was a composite endpoint of bleeding complications, deep surgical site infection, deep vein thrombosis, pulmonary embolism, and death within 90 days of injury. A Global Rank test and weighted time to event analysis were used to determine the probability of treatment superiority for LMWH, given a 9% patient preference margin for oral administration over skin injections.
RESULTS


Overall, 18 different combinations of outcomes were experienced by patients in the study. Ninety-nine patients in the aspirin group (59.9%) and 98 patients in the LMWH group (59.4%) were event-free within 90 days of injury. Using a Global Rank test, the LMWH had a 50.4% (95% CI, 47.7-53.2%, p = 0.73) probability of treatment superiority over aspirin. In the time to event analysis, LMWH had a 60.5% probability of treatment superiority over aspirin with considerable uncertainty (95% CI, 24.3-88.0%, p = 0.59).
CONCLUSION


The findings of the Global Rank test suggest no evidence of superiority between LMWH or aspirin for VTE prevention in fracture patients. LMWH demonstrated a 60.5% VTE prevention benefit in the weighted time to event analysis. However, this difference did not reach statistical significance and was similar to the elicited patient preferences for aspirin.",2020,The findings of the Global Rank test suggest no evidence of superiority between LMWH or aspirin for VTE prevention in fracture patients.,"['orthopaedic trauma patients', 'adult patients admitted to an academic trauma center with an operative extremity fracture, or a pelvis or acetabular fracture', 'fracture patients']","['LMWH', 'aspirin versus low-molecular-weight heparin (LMWH', 'LMWH or aspirin', 'Aspirin versus low-molecular-weight heparin', 'aspirin', 'LMWH (enoxaparin']","['composite endpoint of bleeding complications, deep surgical site infection, deep vein thrombosis, pulmonary embolism, and death within 90 days of injury']","[{'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0347804', 'cui_str': 'Fracture of acetabulum'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",99.0,0.246285,The findings of the Global Rank test suggest no evidence of superiority between LMWH or aspirin for VTE prevention in fracture patients.,"[{'ForeName': 'Bryce E', 'Initials': 'BE', 'LastName': 'Haac', 'Affiliation': 'Department of Surgery, R A Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Nathan N', 'Initials': 'NN', 'LastName': ""O'Hara"", 'Affiliation': 'Department of Orthopaedics, R A Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Theodore T', 'Initials': 'TT', 'LastName': 'Manson', 'Affiliation': 'Department of Orthopaedics, R A Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Slobogean', 'Affiliation': 'Department of Orthopaedics, R A Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Renan C', 'Initials': 'RC', 'LastName': 'Castillo', 'Affiliation': 'Department of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Robert V', 'Initials': 'RV', 'LastName': ""O'Toole"", 'Affiliation': 'Department of Orthopaedics, R A Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Stein', 'Affiliation': 'Department of Surgery, R A Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0235628']
1788,32745732,Smartphone-based application to improve medication adherence in patients after surgical coronary revascularization.,"BACKGROUND


Secondary preventive therapies play a key role in the prevention of adverse events after coronary artery bypass grafting (CABG). However, adherence to secondary preventive drugs after CABG is often poor. With the increasing penetration of smartphones, health-related smartphone applications might provide an opportunity to improve medication adherence. We aimed to evaluate the effectiveness and feasibility of using a smartphone-based application to improve medication adherence in patients after CABG.
METHODS


The Measurement and Improvement Studies of Surgical coronary revascularizatION: medication adherence (MISSION-2) study is a multicenter randomized controlled trial that planned to enroll over 1000 patients who underwent isolated CABG at one of four large teaching hospitals in China; all enrolled participants had access to a smartphone and were able to operate at least three smartphone applications. The investigators randomly assigned the participants to one of two groups: (1) the intervention group with an advanced smartphone application for 6 months which was designed specifically for this trial and did not exist before. Participants could receive medication reminders and cardiac health education by the smartphone application or (2) the control group with usual care. The primary outcome was CABG secondary preventive medication adherence as measured by the translated Chinese version of the 8-item Morisky Medication Adherence Scale (MMAS-8) at 6 months after randomization. The secondary outcomes were mortality, major adverse cardiovascular and cerebrovascular events (MACCE), cardiovascular rehospitalization, self-reported secondary preventive medication use after 6 months of follow-up, blood pressure (BP), body mass index (BMI), and self-reported smoking status. All analyses were conducted using the intention-to-treat principle.
RESULTS


A total of 1000 patients (mean age, 57.28 [SD, 9.09] years; 85.5% male) with coronary heart disease after CABG were enrolled between September 2015 and September 2016 and were randomly assigned to the intervention (n = 501) or control group (n = 499). At 6 months, the proportion of low-adherence participants, categorized by MMAS-8 scores, was 11.8% in the intervention group and 11.7% in the control group (RR = 1.005, 95% CI 0.682 to 1.480, P = 1.000). Similar results were found in sensitivity analyses that considered participants who withdrew from the study, or were lost to follow-up as nonadherent. There were no significant differences in the secondary clinical outcome measures, and there were no significant differences in the primary outcome across the subgroups tested. In the intervention group, the proportion of participants who used and operated the application during the first month after CABG was 88.1%; however, the use rate decreased sharply from 42.5% in the second month to 9.2% by the end of the study (6 months).
CONCLUSIONS


A smartphone-based application supporting secondary prevention among patients after CABG did not lead to a greater adherence to secondary preventive medications. The limited room for improvement in medication adherence and the low participants' engagement with the smartphone applications might account for these non-significant outcomes.",2020,A smartphone-based application supporting secondary prevention among patients after CABG did not lead to a greater adherence to secondary preventive medications.,"['patients after CABG', 'coronary artery bypass grafting (CABG', 'patients after surgical coronary revascularization', '1000 patients who underwent isolated CABG at one of four large teaching hospitals in China; all enrolled participants had access to a smartphone and were able to operate at least three smartphone applications', '1000 patients (mean age, 57.28 [SD, 9.09] years; 85.5% male) with coronary heart disease after CABG were enrolled between September 2015 and September 2016']","['Surgical coronary revascularizatION', 'smartphone-based application', 'Smartphone-based application', 'medication reminders and cardiac health education by the smartphone application or (2) the control group with usual care', 'intervention group with an advanced smartphone application']","['proportion of low-adherence participants, categorized by MMAS-8 scores', 'mortality, major adverse cardiovascular and cerebrovascular events (MACCE), cardiovascular rehospitalization, self-reported secondary preventive medication use after 6 months of follow-up, blood pressure (BP), body mass index (BMI), and self-reported smoking status', 'CABG secondary preventive medication adherence as measured by the translated Chinese version of the 8-item Morisky Medication Adherence Scale (MMAS-8', 'medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040710', 'cui_str': 'Translating'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1000.0,0.0677726,A smartphone-based application supporting secondary prevention among patients after CABG did not lead to a greater adherence to secondary preventive medications.,"[{'ForeName': 'Chunyu', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Chongyang', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Junzhe', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Hanning', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Limeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Huishan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiovascular Surgery, General Hospital of Shenyang Military Region, Shenyang, Liaoning, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiovascular Surgery, TEDA International Cardiovascular Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Tianjin, China.'}, {'ForeName': 'Chenfei', 'Initials': 'C', 'LastName': 'Rao', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: raochenfeifuwai@126.com.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Department of Cardiovascular Surgery, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. Electronic address: zhengzhe@fuwai.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.06.019']
1789,32745733,"Rationale and design of a prospective, randomized, controlled, multicenter study to evaluate the safety and efficacy of transcatheter heart valve replacement in female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA] trial).","BACKGROUND


Limited data suggest that transcatheter (TAVR) as compared with surgical aortic valve replacement (SAVR) may be more effective in female than male patients. To date, most evidence is derived from subgroup analyses of large trials, and a dedicated randomized trial evaluating whether there is a difference in outcomes between these interventions in women is warranted. The RHEIA trial will compare the safety and efficacy of TAVR with SAVR in women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk.
METHODS/DESIGN


The RHEIA trial is a prospective, randomized, controlled study that will enroll up to 440 patients across 35 sites in Europe. Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status, will be randomized 1:1 to undergo aortic valve intervention with either transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra device or SAVR and followed up for 1 year. The objective is to determine whether TAVR is non-inferior to SAVR in this patient population and, if this is fulfilled whether TAVR is actually superior to SAVR. The primary safety/efficacy endpoint is a composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure) at 1 year post-procedure. Other outcomes (assessed at 30 days and/or 1 year) include all-cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life.
DISCUSSION


The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk. The results will be the first to provide specific randomized evidence to guide treatment selection in female patients with severe symptomatic aortic stenosis.
TRIAL REGISTRATION


clinicaltrials.gov: NCT04160130.",2020,"The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk.","['440 patients across 35 sites in Europe', 'female than male patients', 'Women with severe symptomatic aortic stenosis, with any but prohibitive surgical risk status', 'female patients with severe symptomatic aortic stenosis', 'women with severe symptomatic aortic stenosis requiring aortic valve intervention, irrespective of surgical risk', 'female patients with severe symptomatic aortic stenosis requiring aortic valve intervention (Randomized researcH in womEn all comers wIth Aortic stenosis [RHEIA', 'women with severe symptomatic aortic stenosis']","['surgical aortic valve replacement (SAVR', 'transcatheter (TAVR', 'transcatheter heart valve replacement', 'TAVR with SAVR', 'TAVR']","['composite of all-cause mortality, all stroke, and re-hospitalization (for valve or procedure-related symptoms or worsening congestive heart failure', 'safety and efficacy', 'cause mortality; bleeding, vascular, cardiac, cerebrovascular and renal complications; aortic valve prosthesis and left ventricular function; cognitive function, health status, and quality of life']","[{'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0190173', 'cui_str': 'Heart valve replacement'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0182431', 'cui_str': 'Aortic valve prosthesis'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.159675,"The RHEIA study has been designed to evaluate the safety and efficacy of TAVR compared with SAVR specifically in women with severe symptomatic aortic stenosis, irrespective of the level of surgical risk.","[{'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Eltchaninoff', 'Affiliation': 'Department of Cardiology, Rouen University Hospital, FHU REMOD-VHF, Rouen, France. Electronic address: helene.eltchaninoff@chu-rouen.fr.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Bonaros', 'Affiliation': 'Department of Cardiac Surgery, Medical University of Innsbruck, Innsbruck, Austria. Electronic address: nikolaos.bonaros@tirol-kliniken.at.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Prendergast', 'Affiliation': ""St. Thomas' Hospital, London, United Kingdom. Electronic address: bernard.prendergast@gstt.nhs.uk.""}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Nietlispach', 'Affiliation': 'CardioVascularCenter, Hirslanden Klinik Im Park, Zurich, Switzerland. Electronic address: fabian.nietlispach@hirslanden.ch.'}, {'ForeName': 'Mariuca', 'Initials': 'M', 'LastName': 'Vasa-Nicotera', 'Affiliation': 'University Heart Center Frankfurt, Frankfurt, Germany. Electronic address: mariuca.vasa-nicotera@kgu.de.'}, {'ForeName': 'Alaide', 'Initials': 'A', 'LastName': 'Chieffo', 'Affiliation': 'Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy. Electronic address: chieffo.alaide@hsr.it.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Pibarot', 'Affiliation': 'Department of Cardiology, Quebec Heart & Lung Institute, Laval University, Quebec City, QC, Canada. Electronic address: philippe.pibarot@med.ulaval.ca.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bramlage', 'Affiliation': 'Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany. Electronic address: peter.bramlage@ippmed.de.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Sykorova', 'Affiliation': 'Edwards Lifesciences, Prague, Czech Republic. Electronic address: lenka_sykorova@edwards.com.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Kurucova', 'Affiliation': 'Edwards Lifesciences, Prague, Czech Republic. Electronic address: jana_kurucova@edwards.com.'}, {'ForeName': 'Jeroen J', 'Initials': 'JJ', 'LastName': 'Bax', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: j.j.bax@lumc.nl.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland. Electronic address: Stephan.Windecker@insel.ch.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Dumonteil', 'Affiliation': 'Groupe Cardiovasculaire Interventionnel, Clinique Pasteur Toulouse, France. Electronic address: ndumonteil@clinique-pasteur.com.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Tchetche', 'Affiliation': 'Groupe Cardiovasculaire Interventionnel, Clinique Pasteur Toulouse, France. Electronic address: dtchetche@clinique-pasteur.com.'}]",American heart journal,['10.1016/j.ahj.2020.06.016']
1790,32745734,Optimal antiplatelet therapy for prevention of gastrointestinal injury evaluated by ANKON magnetically controlled capsule endoscopy: Rationale and design of the OPT-PEACE trial.,"BACKGROUND


Gastrointestinal injury is a common complication in patients treated with antiplatelet agents after percutaneous coronary intervention (PCI). However, the effects of different antiplatelet regimens on the incidence and severity of gastrointestinal injury have not been well studied, principally due to the lack of a low-risk sensitive and accurate detection system.
TRIAL DESIGN


OPT-PEACE is a multicenter, randomized, double-blind, placebo-controlled trial. Gastrointestinal injury will be evaluated with the ANKON magnetically controlled capsule endoscopy system (AMCE), a minimally invasive approach for detecting mucosal lesions in the stomach, duodenum and small intestine. Patients without AMCE-detected gastrointestinal erosions, ulceration or bleeding after drug-eluting stent implantation are enrolled and treated with open-label aspirin (100 mg/d) plus clopidogrel (75 mg/d) for 6 months. Thereafter, 480 event-free patients will undergo repeat AMCE and are randomly assigned in a 1:1:1 ratio to receive aspirin plus clopidogrel, aspirin plus placebo or clopidogrel plus placebo for an additional 6 months. A final AMCE is performed at 12 months. The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
CONCLUSIONS


OPT-PEACE is the first study to investigate the incidence and severity of gastrointestinal injury in patients receiving different antiplatelet therapy regimens after stent implantation. This trial will inform clinical decision-making for personalized antiplatelet therapy post-PCI.",2020,"The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
","['480 event-free patients will undergo repeat AMCE', 'patients receiving different antiplatelet therapy regimens after stent implantation', 'patients treated with antiplatelet agents after percutaneous coronary intervention (PCI']","['aspirin plus clopidogrel, aspirin plus placebo or clopidogrel plus placebo', 'open-label aspirin', 'clopidogrel', 'placebo']","['incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding', 'gastrointestinal erosions, ulceration or bleeding']","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet agent'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1261962', 'cui_str': 'Gastrointestinal erosion'}]",,0.524049,"The primary endpoint is the incidence of gastric or intestinal mucosal lesions (erosions, ulceration, or bleeding) within 12 months after enrollment.
","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiaozeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bao', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Endoscopy, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Heyang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Zhaoshen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Digestive Endoscopy Center, Department of Gastroenterology, Shanghai Changhai Hospital, Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Mount Sinai Heart and the Cardiovascular Research Foundation, New York.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, General hospital of Northern Theater Command, Shenyang, China. Electronic address: hanyaling@263.net.'}]",American heart journal,['10.1016/j.ahj.2020.06.004']
1791,32761731,A lifestyle intervention randomized controlled trial in obese women with infertility improved body composition among those who experienced childhood adversity.,"Previous research indicates that tailoring lifestyle interventions to participant characteristics optimizes intervention effectiveness. Our objective was to assess whether the effects of a preconception lifestyle intervention in obese infertile women depended on women's exposure to adversity in childhood. A follow-up of a preconception lifestyle intervention randomized controlled trial (the LIFEstyle study) was conducted in the Netherlands among 577 infertile women (age 18-39 years) with a body mass index (BMI) ≥29 kg/m 2  at time of randomization; N = 110 (19%) consented to the follow-up assessment, 6 years later. A 6-month preconception lifestyle intervention aimed weight loss through improving diet and increasing physical activity. The control group received care as usual. Outcome measures included weight, BMI, waist and hip circumference, body fat percentage, blood pressure and metabolic syndrome. The potential moderator, childhood adversity, was assessed with the Life Events Checklist-5 questionnaire. Among the 110 women in our follow-up study, n = 65 (59%) reported no childhood adverse events, n = 28 (25.5%) reported 1 type of childhood adverse events and n = 17 (15.5%) reported ≥2 types of childhood adverse events. Regression models showed significant interactions between childhood adversity and effects of lifestyle intervention at the 6-year follow-up. Among women who experienced childhood adversity, the intervention significantly reduced weight (-10.0 [95% CI -18.5 to -1.5] kg, p = 0.02), BMI (-3.2 [-6.1 to -0.2] kg/m 2  , p = 0.04) and body fat percentage (-4.5 [95% CI -7.2 to -1.9] p < 0.01). Among women without childhood adversity, the intervention did not affect these outcomes (2.7 [-3.9 to 9.4] kg, p = 0.42), (0.9 [-1.4 to 3.3] kg/m 2  , p = 0.42) and (1.7 [95% CI -0.3 to 3.7] p = 0.10), respectively. Having a history of childhood adversity modified the effect of a preconception lifestyle intervention on women's body composition. If replicated, it may be important to consider childhood adversity as a determinant of lifestyle intervention effectiveness.",2020,"Among women who experienced childhood adversity, the intervention significantly reduced weight (-10.0","[""women's body composition"", '577 infertile women (age 18-39 years) with a body mass index (BMI) ≥ 29 kg/m 2  at time of randomization', ""obese infertile women depended on women's exposure to adversity in childhood"", 'obese women with infertility']",['preconception lifestyle intervention'],"['weight, body mass index (BMI), waist and hip circumference, body fat percentage, blood pressure and metabolic syndrome', 'weight', 'body fat percentage', 'improved body composition', 'BMI', 'weight loss', '1 type of childhood adverse events', 'childhood adverse events']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",577.0,0.0543525,"Among women who experienced childhood adversity, the intervention significantly reduced weight (-10.0","[{'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'van Dammen', 'Affiliation': 'Department of Human Development & Family Studies, Iowa State University, Ames, Iowa, USA.'}, {'ForeName': 'Nicole R', 'Initials': 'NR', 'LastName': 'Bush', 'Affiliation': 'Departments of Psychiatry and Pediatrics, Center for Health and Community, Division of Developmental Medicine, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'de Rooij', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands.'}, {'ForeName': 'Ben Willem', 'Initials': 'BW', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Mutsaerts', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'van Oers', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Groen', 'Affiliation': 'Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'Hoek', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Roseboom', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands.'}]",Stress and health : journal of the International Society for the Investigation of Stress,['10.1002/smi.2976']
1792,32758205,Correction to: Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial).,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,[],['syndesmotic screw'],[],[],"[{'cui': 'C0005975', 'cui_str': 'Bone screw'}]",[],,0.118978,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Dingemans', 'Affiliation': 'Department of Surgery, Trauma Unit, Academic Medical Centre, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.'}, {'ForeName': 'M F N', 'Initials': 'MFN', 'LastName': 'Birnie', 'Affiliation': 'Department of Surgery, Trauma Unit, Academic Medical Centre, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.'}, {'ForeName': 'F R K', 'Initials': 'FRK', 'LastName': 'Sanders', 'Affiliation': 'Department of Surgery, Trauma Unit, Academic Medical Centre, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.'}, {'ForeName': 'M P J', 'Initials': 'MPJ', 'LastName': 'van den Bekerom', 'Affiliation': 'Department of Orthopedic Surgery, OLVG, P.O. Box 95500, 1090 HM, Amsterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Backes', 'Affiliation': 'Department of Surgery, Trauma Unit, Academic Medical Centre, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'van Beeck', 'Affiliation': 'Department of Public Health, Erasmus MC, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.'}, {'ForeName': 'F W', 'Initials': 'FW', 'LastName': 'Bloemers', 'Affiliation': 'Department of Surgery, Trauma Unit, VU University Medical Centre, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'van Dijkman', 'Affiliation': 'Department of Surgery, Flevo Hospital, P.O. Box 3005, 1300 EG, Almere, The Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Flikweert', 'Affiliation': 'Department of Surgery, Deventer Hospital, P.O. Box 5001, 7400 GC, Deventer, The Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Haverkamp', 'Affiliation': 'Department of Surgery, Slotervaart Hospital, P.O. Box 90440, 1006 BK, Amsterdam, The Netherlands.'}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Holtslag', 'Affiliation': 'Department of Surgery, Trauma Unit, Academic Medical Centre, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Hoogendoorn', 'Affiliation': 'Department of Surgery, Haaglanden MC, P.O. Box 432, 2501 CK, The Hague, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Joosse', 'Affiliation': 'Department of Surgery, Noordwest Hospital Group, P.O. Box 501, 1815 JD, Alkmaar, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Parkkinen', 'Affiliation': 'Department of Orthopaedics and Traumatology, Helsinki University Hospital, Topeliuksenkatu 5, 00260, Helsinki, Finland.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Roukema', 'Affiliation': 'Department of Surgery, Maasstad Hospital, P.O. Box 9100, 3007 AC, Rotterdam, The Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sosef', 'Affiliation': 'Department of Surgery, Spaarne Hospital, P.O. Box 770, 2130 AT, Hoofddorp, The Netherlands.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Twigt', 'Affiliation': 'Department of Surgery, BovenIJ Hospital, P.O. Box 37610, 1030 BD, Amsterdam, The Netherlands.'}, {'ForeName': 'R N', 'Initials': 'RN', 'LastName': 'van Veen', 'Affiliation': 'Department of Surgery, OLVG, P.O. Box 95500, 1090 HM, Amsterdam, The Netherlands.'}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'van der Veen', 'Affiliation': 'Department of Surgery, Catharina Hospital, P.O. Box 1350, 5602 ZA, Eindhoven, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Surgery, Spaarne Hospital, P.O. Box 770, 2130 AT, Hoofddorp, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Winkelhagen', 'Affiliation': 'Department of Surgery, Westfries Hospital, P.O. Box 600, 1620 AR, Hoorn, The Netherlands.'}, {'ForeName': 'B C', 'Initials': 'BC', 'LastName': 'van der Zwaard', 'Affiliation': ""Department of Orthopaedics, Jeroen Bosch Hospital, P.O. Box 90153, 5200 ME, 's-Hertogenbosch, The Netherlands.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'van Dieren', 'Affiliation': 'Department of Surgery, Trauma Unit, Academic Medical Centre, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Goslings', 'Affiliation': 'Department of Orthopedic Surgery, OLVG, P.O. Box 95500, 1090 HM, Amsterdam, The Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Schepers', 'Affiliation': 'Department of Surgery, Trauma Unit, Academic Medical Centre, University of Amsterdam, P.O. Box 22660, 1100 DD, Amsterdam, The Netherlands. t.schepers@amc.nl.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03516-7']
1793,32758684,Is it worth using low-cost glass ionomer cements for occlusal ART restorations in primary molars? 2-year survival and cost analysis of a Randomized clinical trial.,"OBJECTIVE


To evaluate the 2-year survival rate and the cost-effectiveness of Atraumatic Restorative Treatment (ART) using three different glass ionomer cements (GICs) for restoring occlusal dentin caries lesions in primary molars.
METHODS


One hundred and fifty (150) 4-8-year-old children were selected, randomly allocated and treated in school tables according to the restorative material: Fuji IX Gold Label (GC Corp), Vitro Molar (nova DFL) and Maxxion R (FGM), the latter two being low-cost brands. Materials and professionals' costs were considered to analyse baseline total cost, and from this the cumulative cost of each treatment was calculated. Restoration assessments were performed after 2, 6, 12 and 24 months by an independent calibrated examiner. Restoration survival was estimated using Kaplan-Meier survival analysis and Cox regression was used to test association with clinical factors. Bootstrap regression (1,000 replications) compared material´s cost over time and Monte-Carlo simulation was used to build cost-effectiveness scatter plots.
RESULTS


The overall survival rate of occlusal ART restorations after 2 years was 53% (Fuji IX = 72.7%; Vitro Molar = 46.5%; Maxxion R = 39.6%). Restorations performed with Vitro Molar and Maxxion R were more likely to fail when compared to Fuji IX. At baseline, Fuji IX was the more expensive option (p < 0.001), however, considering the simulation of accumulated cost caused by failures until 2-year evaluation, no difference was found between the groups.
CONCLUSIONS


After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).",2020,"After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).","['150 4-8-year-old children', 'primary molars']","['glass ionomer cements (GICs', 'restorative material: Fuji IX Gold Label (GC Corp), Vitro Molar (nova DFL) and Maxxion R (FGM', 'Atraumatic Restorative Treatment (ART', 'Fuji IX']","['overall survival rate of occlusal ART restorations', 'Restoration survival', '2-year survival rate']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}, {'cui': 'C0182981', 'cui_str': 'Dental restorative material'}, {'cui': 'C0671561', 'cui_str': 'fuji IX'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C3529286', 'cui_str': 'Maxxion'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.0977731,"After 2 years' follow up, restorations performed with Fuji IX proved to be superior in terms of survival, with a similar overall cost, when compared to low-cost glass ionomers cements (Vitro Molar and Maxxion R).","[{'ForeName': 'Isabel Cristina', 'Initials': 'IC', 'LastName': 'Olegário', 'Affiliation': 'Department of Public and Child Dental Health, Dublin Dental University Hospital, University of Dublin, Trinity College, Dublin, Ireland; Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Nathalia de Miranda', 'Initials': 'NM', 'LastName': 'Ladewig', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Hesse', 'Affiliation': 'Department of Cariology, Endodontics and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, the Netherlands.'}, {'ForeName': 'Clarissa Calil', 'Initials': 'CC', 'LastName': 'Bonifácio', 'Affiliation': 'Department of Cariology, Endodontics and Pedodontology, Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, the Netherlands.'}, {'ForeName': 'Mariana Minatel', 'Initials': 'MM', 'LastName': 'Braga', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'José Carlos Pettorossi', 'Initials': 'JCP', 'LastName': 'Imparato', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fausto Medeiros', 'Initials': 'FM', 'LastName': 'Mendes', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Daniela Prócida', 'Initials': 'DP', 'LastName': 'Raggio', 'Affiliation': 'Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: danielar@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103446']
1794,32758689,"SARS-CoV-2 clearance in COVID-19 patients with Novaferon treatment: A randomized, open-label, parallel-group trial.","BACKGROUND


The antiviral effects of Novaferon, a potent antiviral protein drug, on COVID-19 was evaluated in the laboratory, and in a randomized, open-label, parallel-group trial.
METHODS


In the laboratory, Novaferon's inhibition of viral replication in cells infected with SARS-CoV-2, and prevention of SARS-CoV-2 entry into healthy cells was determined. Antiviral effects of Novaferon in COVID-19 patients with treatment of Novaferon, Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir were evaluated. The primary endpoint was the SARS-CoV-2 clearance rates on day six of treatment, and the secondary endpoint was the time to SARS-CoV-2 clearance.
RESULTS


Novaferon inhibited viral replication (EC 50 =1.02ng/ml), and prevented viral infection (EC 50 =0.10ng/ml). Results from the 89 enrolled COVID-19 patients showed that both Novaferon and Novaferon plus Lopinavir/Ritonavir groups had significantly higher viral clearance rates on day six than Lopinavir/Ritonavir group (50.0% vs. 24.1%, p=0.0400, and 60.0% vs. 24.1%, p=0.0053). The median time to viral clearance was six days, six days, and nine days for three groups, respectively, a 3-day reduction in both the Novaferon and Novaferon plus Lopinavir/Ritonavir groups compared with the Lopinavir/Ritonavir group.
CONCLUSIONS


Novaferon exhibited anti-SARS-CoV-2 effects in vitro and in COVID-19 patients. These data justify further evaluation of Novaferon.
TRIAL REGISTRATION NUMBER


Number ChiCTR2000029496 at the Chinese Clinical Trial Registry (http://www.chictr.org.cn/).",2020,"RESULTS


Novaferon inhibited the viral replication (EC 50  = 1.02 ng/ml), and prevented viral infection (EC 50  = 0.10 ng/ml).","['COVID-19 patients with treatment of Novaferon', 'COVID-19 Patients with Novaferon Treatment']","['Lopinavir/Ritonavir', 'Novaferon plus Lopinavir/Ritonavir, or Lopinavir/Ritonavir', 'Novaferon', '6than Lopinavir/Ritonavir']","['viral infection', 'SARS-CoV-2 Clearance', 'Median time to viral clearance', 'viral replication', 'SARS-CoV-2 clearance rates', 'time to SARS-CoV-2 clearance', 'viral clearance rates']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3273451', 'cui_str': 'Novaferon'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C3273451', 'cui_str': 'Novaferon'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0042774', 'cui_str': 'Virus Replication'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}]",89.0,0.111733,"RESULTS


Novaferon inhibited the viral replication (EC 50  = 1.02 ng/ml), and prevented viral infection (EC 50  = 0.10 ng/ml).","[{'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Yanwen', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Medicine, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Baoying', 'Initials': 'B', 'LastName': 'Huang', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Yaxiong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zuo', 'Affiliation': 'Department of Intensive Care Unit, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': 'Department of Pediatrics, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Internal Medicine, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Peihua', 'Initials': 'P', 'LastName': 'Niu', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Wenlong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Cai', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China.'}, {'ForeName': 'Xinqiang', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, National Clinical Research Center for Metabolic Diseases, The Second Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yongfang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: jiangyongfang@csu.edu.cn.'}, {'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Infectious Diseases, The First Hospital of Changsha, Changsha, China. Electronic address: 1286779459@qq.com.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China. Electronic address: tanwj@ivdc.chinacdc.cn.'}, {'ForeName': 'Guozhong', 'Initials': 'G', 'LastName': 'Gong', 'Affiliation': 'Department of Infectious Diseases, The Second Xiangya Hospital, Central South University, Changsha, China. Electronic address: gongguozhong@csu.edu.cn.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.07.053']
1795,32739495,Design and rationale of a multicenter defeat alcoholic steatohepatitis trial: (DASH) randomized clinical trial to treat alcohol-associated hepatitis.,"BACKGROUND/AIMS


Despite high mortality of alcohol-associated hepatitis, there has been limited advancement in treatment strategies. Defeat Alcoholic Steatohepatitis (DASH) is a multicenter, randomized, double-blind controlled trial whose primary objective was to evaluate the safety and efficacy of a novel combination of 3 drugs targeting different perturbations in AH.
METHODS


Severe AH was diagnosed by liver biopsy or clinical and biochemical criteria and model for end stage liver disease (MELD) score ≥ 20 stratified by MELD scores (20-25 and ≥ 26) and randomized to a combination of an interleukin receptor 1 antagonist, Anakinra(100 mg daily for 14 days) to suppress acute inflammation, pentoxifylline (400 mg three times a day for 28 days) to prevent hepatorenal syndrome, and zinc sulfate (220 mg orally once daily for 6 months) or the standard of care therapy including methylprednisolone 32 mg orally once daily for 28 days. The primary efficacy outcome was the unadjusted log-rank test of the Kaplan-Meier survival estimates for the two treatment groups at 180 days.
RESULTS


Between July 2012 to March 2018, 500 subjects with severe AH were screened of which 104 subjects were enrolled with MELD score of 25.6 ± 3.2 (20.0-35.0) in the investigational arm and 25.8 ± 4.5 (20.0-40.0) in the standard of care arm. Causes of screen failures included not meeting eligibility criteria (n = 347), declining to participate (n = 39), and other reasons (n = 10).
CONCLUSIONS


Data from the DASH consortium studies will determine if a combination of drugs targeting multiple mechanisms of injury in the severe AH will improve clinical outcomes.",2020,"The primary efficacy outcome was the unadjusted log-rank test of the Kaplan-Meier survival estimates for the two treatment groups at 180 days.
","['Between July 2012 to March 2018, 500 subjects with severe AH were screened of which 104 subjects were enrolled with MELD score of 25.6\u202f±\u202f3.2 (20.0-35.0) in the investigational arm and 25.8\u202f±\u202f4.5 (20.0-40.0) in the standard of care arm', 'Severe AH was diagnosed by liver biopsy or clinical and biochemical criteria and model for end stage liver disease (MELD) score\u202f≥']","['interleukin receptor 1 antagonist, Anakinra(100\u202fmg daily for 14\u202fdays) to suppress acute inflammation, pentoxifylline', 'zinc sulfate (220\u202fmg orally once daily for 6\u202fmonths) or the standard of care therapy including methylprednisolone']","['safety and efficacy', 'unadjusted log-rank test of the Kaplan-Meier survival estimates']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C4048785', 'cui_str': 'Model for end stage liver disease score'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0193388', 'cui_str': 'Biopsy of liver'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3826979', 'cui_str': 'Model for end-stage liver disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0206553', 'cui_str': 'Interleukin Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0333361', 'cui_str': 'Acute inflammation'}, {'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0078794', 'cui_str': 'Zinc Sulfate'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",104.0,0.725088,"The primary efficacy outcome was the unadjusted log-rank test of the Kaplan-Meier survival estimates for the two treatment groups at 180 days.
","[{'ForeName': 'Srinivasan', 'Initials': 'S', 'LastName': 'Dasarathy', 'Affiliation': 'Cleveland Clinic, USA. Electronic address: dasaras@ccf.org.'}, {'ForeName': 'Mack C', 'Initials': 'MC', 'LastName': 'Mitchell', 'Affiliation': 'University of Texas at Southwestern University, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Barton', 'Affiliation': 'University of Massachusetts, USA.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'McClain', 'Affiliation': 'University of Louisville, USA.'}, {'ForeName': 'Gyongyi', 'Initials': 'G', 'LastName': 'Szabo', 'Affiliation': 'Harvard Medical School & Beth Israel Deaconess Medical Center, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Nagy', 'Affiliation': 'Cleveland Clinic, USA.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Radaeva', 'Affiliation': 'National Institute of Alcohol Abuse and Alcoholism, USA.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'McCullough', 'Affiliation': 'Cleveland Clinic, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106094']
1796,32739652,"Extended antiplatelet therapy with clopidogrel alone versus clopidogrel plus aspirin after completion of 9- to 12-month dual antiplatelet therapy for acute coronary syndrome patients with both high bleeding and ischemic risk. Rationale and design of the OPT-BIRISK double-blinded, placebo-controlled randomized trial.","BACKGROUND


Dual antiplatelet therapy with aspirin and a P2Y12 inhibitor is the cornerstone for prevention ischemic events in patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention. However, the optimal antiplatelet strategy for ACS patients with both high bleeding and high ischemic risks is unclear.
STUDY DESIGN


The OPT-BIRISK trial is a multicenter, double-blinded, placebo-controlled randomized study designed to test the superiority of extended antiplatelet therapy with clopidogrel monotherapy compared with aspirin and clopidogrel for reduction of bleeding events in ACS patients with both high bleeding and high ischemic risks (""bi-risk""). A total of 7,700 patients who completed 9- to 12-month dual antiplatelet therapy after new-generation drug-eluting stent implantation for the treatment of ACS will be randomized to receive clopidogrel monotherapy or aspirin plus clopidogrel for 9 months followed by aspirin monotherapy for 3 months. The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization. The key secondary end point is major adverse cardiac and cerebral events at 9 months after randomization, defined as a composite of all-cause death, myocardial infarction, stroke, or coronary artery revascularization.
CONCLUSIONS


OPT-BIRISK is the first large-scale randomized trial aimed to explore the optimal antiplatelet strategy for bi-risk ACS patients after percutaneous coronary intervention in current clinical practice. The results will add evidence regarding de-escalation antiplatelet therapy for patients at special risk.",2020,"The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization.","['7,700 patients who completed 9- to 12-month dual antiplatelet therapy after new-generation drug-eluting stent implantation for the treatment of ACS', 'patients with acute coronary syndromes (ACS) and undergoing percutaneous coronary intervention', 'acute coronary syndrome patients with both high bleeding and ischemic risk', 'patients at special risk', 'ACS patients with both high bleeding and high ischemic risks (""bi-risk']","['clopidogrel alone versus clopidogrel plus aspirin', 'aspirin and a P2Y12 inhibitor', 'aspirin monotherapy', 'aspirin and clopidogrel', 'clopidogrel monotherapy or aspirin plus clopidogrel', 'placebo']","['major adverse cardiac and cerebral events', 'composite of all-cause death, myocardial infarction, stroke, or coronary artery revascularization', 'bleeding events', 'Bleeding Academic Research Consortium type 2, 3, or 5 bleedings']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205555', 'cui_str': 'Special'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]",7700.0,0.0625651,"The primary end point is Bleeding Academic Research Consortium type 2, 3, or 5 bleedings at 9 months after randomization.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Quanmin', 'Initials': 'Q', 'LastName': 'Jing', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Xiaozeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Shubing', 'Initials': 'S', 'LastName': 'Qiao', 'Affiliation': 'Fu Wai Hospital of Chinese Academy of Medical Science, Beijing, China.'}, {'ForeName': 'Shaoliang', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Nanjing First Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, FL, USA.'}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Cardiology, General Hospital of Northern Theater Command, Shenyang, China. Electronic address: hanyaling@263.net.'}]",American heart journal,['10.1016/j.ahj.2020.07.005']
1797,32739670,"The effects of a transitional care program on discharge readiness, transitional care quality, health services utilization and satisfaction among Chinese kidney transplant recipients: A randomized controlled trial.","BACKGROUND


Kidney transplantation is the major treatment for end-stage renal disease (ESRD). However, kidney transplant recipients (KTRs) face severe challenges during the transition period from hospital discharge to home, increasing the risk of early hospital readmission (EHR) and affecting patient safety. Nevertheless, knowledge of effective transitional care for KTRs is limited in China.
OBJECTIVE


To evaluate the effectiveness of an innovative transitional care program in improving discharge readiness, transitional care quality, health services utilization and patient satisfaction among KTRs in China.
DESIGN


A prospective randomized controlled trial.
SETTINGS AND PARTICIPANTS


Patients admitted to undergo kidney transplantation were recruited in a general tertiary hospital in Chengdu, China.
METHODS


A total of 220 eligible patients were recruited and randomly assigned to the intervention and control groups. Participants in the intervention group received a transitional care intervention developed by the research team, including a risk assessment for early readmission, health education from admission to predischarge, individualized discharge planning, and a telephone follow-up once per week for one month and WeChat follow-up postdischarge. The control group received routine care of comparable length and follow-up contact. A trained research assistant collected all patients' baseline data on admission (T0), evaluated the discharge readiness (by the Readiness for Hospital Discharge Scale) on the day of discharge (T1), collected data on transitional care quality (by the Care Transition Measure-15) and patients' satisfaction with transitional care services (by a self-developed patient satisfaction scale) on the 30th day postdischarge (T2), and collected data on hospital readmission, unscheduled outpatient department visits, and emergency room visits on the 30th and 90th days (by a self-developed health services utilization record table) (T3) postdischarge. Intervention effects were analyzed using independent samples t-tests, Wilcoxon-Mann-Whitney U tests, Chi-square tests or Fisher's exact test.
RESULTS


Compared with the control group, the intervention group showed significantly better discharge readiness (personal status, P<0.001; knowledge, P = 0.010; coping ability, P<0.001; expected support, P = 0.007; total score, P<0.001), better transitional care quality (importance of preferences, P<0.001; management preparation, P<0.001; critical understanding, P = 0.003; written and understandable care plan, P = 0.012; total score, P<0.001), lower readmission rate at T2 (P = 0.033) and at T3 (P = 0.013), lower emergency room visit rate at T3 (P = 0.014), and better satisfaction with transitional care services (P<0.001).
CONCLUSIONS


This study provides evidence that an innovative transitional care program is effective in promoting KTRs' discharge readiness, transitional care quality, reducing hospital readmission and emergency room visits, and improving their satisfaction with transitional care services.
TRIAL REGISTRATION


Clinical Trials ChiCTR1800014971.",2020,"Compared with the control group, the intervention group showed significantly better discharge readiness (personal status, P<0.001; knowledge, P = 0.010; coping ability, P<0.001; expected support, P = 0.007; total score, P<0.001), better transitional care quality (importance of preferences, P<0.001; management preparation, P<0.001; critical understanding, P = 0.003; written and understandable care plan, P = 0.012; total score, P<0.001), lower readmission rate at T2 (P = 0.033) and at T3 (P = 0.013), lower emergency room visit rate at T3 (P = 0.014), and better satisfaction with transitional care services (P<0.001).
","['A total of 220 eligible patients', 'KTRs in China', 'Chinese kidney transplant recipients', 'Patients admitted to undergo kidney transplantation were recruited in a general tertiary hospital in Chengdu, China']","['transitional care program', 'transitional care intervention developed by the research team, including a risk assessment for early readmission, health education from admission to predischarge, individualized discharge planning, and a telephone follow-up once per week for one month and WeChat follow-up postdischarge', 'routine care of comparable length and follow-up contact', 'innovative transitional care program']","['discharge readiness', ""discharge readiness (by the Readiness for Hospital Discharge Scale) on the day of discharge (T1), collected data on transitional care quality (by the Care Transition Measure-15) and patients' satisfaction with transitional care services (by a self-developed patient satisfaction scale) on the 30th day postdischarge (T2), and collected data on hospital readmission, unscheduled outpatient department visits, and emergency room visits on the 30th and 90th days (by a self-developed health services utilization record table) (T3) postdischarge"", 'lower emergency room visit rate', 'lower readmission rate', 'discharge readiness, transitional care quality, health services utilization and satisfaction', 'discharge readiness, transitional care quality, health services utilization and patient satisfaction', 'risk of early hospital readmission (EHR) and affecting patient safety', 'transitional care quality', ""samples t-tests, Wilcoxon-Mann-Whitney U tests, Chi-square tests or Fisher's exact test""]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0012622', 'cui_str': 'Discharge planning'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4019071', 'cui_str': 'Transition Care'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}, {'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}, {'cui': 'C0325045', 'cui_str': 'Martes pennanti'}]",220.0,0.0555818,"Compared with the control group, the intervention group showed significantly better discharge readiness (personal status, P<0.001; knowledge, P = 0.010; coping ability, P<0.001; expected support, P = 0.007; total score, P<0.001), better transitional care quality (importance of preferences, P<0.001; management preparation, P<0.001; critical understanding, P = 0.003; written and understandable care plan, P = 0.012; total score, P<0.001), lower readmission rate at T2 (P = 0.033) and at T3 (P = 0.013), lower emergency room visit rate at T3 (P = 0.014), and better satisfaction with transitional care services (P<0.001).
","[{'ForeName': 'Rujun', 'Initials': 'R', 'LastName': 'Hu', 'Affiliation': 'West China School of Nursing/West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China; Emergency Department, Affiliated Hospital of Zunyi Medical University, Zunyi Medical University, Zunyi 563000, Guizhou, China; School of Nursing, Zunyi Medical University, Zunyi 563000, Guizhou, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Gu', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Qiling', 'Initials': 'Q', 'LastName': 'Tan', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'KaiZhi', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Xiaoyi', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': 'Department of Nephrology, Hemodialysis Center, West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Turun', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'Department of Urology/Institute of Urology/Organ Transplantation Center,West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China.'}, {'ForeName': 'Xiaolian', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'West China School of Nursing/West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China. Electronic address: jiangxiaolianhl@163.com.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103700']
1798,32739671,Effects and mediating mechanisms of a structured limbs-exercise program on general cognitive function in older adults with mild cognitive impairment: A randomized controlled trial.,"BACKGROUND


Exercise is known to prevent cognitive decline. Sleep quality and depression symptoms, which are associated with processing speed, are considered as common mediators in the exercise-cognition putative model. However, these mediating mechanisms have not been empirically tested in an intervention study.
OBJECTIVE


The aim of this study was to evaluate the effects of a structured limbs-exercise program on general cognitive function, and to test the mediating effects and mediating pathways of depressive symptoms, sleep quality and processing speed in the relationship of exercise-induced cognitive benefits.
DESIGN


A two-arm and assessor-blinded randomized controlled trial.
SETTINGS AND PARTICIPANTS


Community-dwelling older adults with mild cognitive impairment living in an urban area in Chifeng, China.
METHODS


Participants (N=116) were randomly allocated to one of the two arms: (1) a 24-week structured limbs-exercise program (3 supervised limb exercise sessions /week, 60 min /session for the first 12 weeks and 3 unsupervised practice sessions /week, 60 min /session for the following 12 weeks) or (2) health promotion classes alone. Measures of depressive symptoms, sleep quality, processing speed, and general cognitive function were collected at baseline, 12-week, and 24-week. Multivariate analysis of variance and structural equation modeling was used to test the effectiveness and mechanisms of structured limbs-exercise-induced cognitive improvement respectively.
RESULTS


The structured limbs-exercise program was beneficial for maintaining general cognitive function at 12 weeks (mean difference = 1.20, 95% CI [0.354, 2.054], p = 0.006) and at 24 weeks (mean difference = 1.59, 95% CI [0.722, 2.458], p = 0.001) in the intervention group. The results from the goodness-of-fit indices of structural equation modeling show as following: (1) The effect of structured limbs-exercise program on cognitive function was partially mediated by depressive symptoms, sleep quality, and processing speed, with 69.22% of joint mediation proportion; (2) Relative to the combined Z values of depressive symptoms and processing speed, sleep quality was more strongly related to cognitive function in the structured limbs-exercise program (Z= 9.294, p<0.01); (3) Processing speed was affected by depressive symptoms, sleep quality, and in turn, yielding a significant effect on cognitive function; and (4) Five potential mediating pathways for improvement in general cognitive function in the structured limbs-exercise intervention were identified.
CONCLUSION


This study shows that this exercise program can maintain general cognitive function for older adults with mild cognitive impairment. Mediating variables include depressive symptoms, sleep quality and processing speed. Future research should continue to incorporate path-oriented intervention strategies in the exercise intervention to maximize improvements in cognitive function. Registration number: ChiCTR1800016299.",2020,"The structured limbs-exercise program was beneficial for maintaining general cognitive function at 12 weeks (mean difference = 1.20, 95% CI [0.354, 2.054], p = 0.006) and at 24 weeks (mean difference = 1.59, 95% CI [0.722, 2.458], p = 0.001) in the intervention group.","['Community-dwelling older adults with mild cognitive impairment living in an urban area in Chifeng, China', 'Participants (N=116', 'older adults with mild cognitive impairment']","['exercise program', '24-week structured limbs-exercise program (3 supervised limb exercise sessions /week, 60\xa0min /session for the first 12 weeks and 3 unsupervised practice sessions /week, 60\xa0min /session for the following 12 weeks) or (2) health promotion classes alone', 'structured limbs-exercise program']","['general cognitive function', 'depressive symptoms, sleep quality, and processing speed', 'depressive symptoms, sleep quality', 'depressive symptoms and processing speed, sleep quality', 'cognitive function', 'depressive symptoms, sleep quality, processing speed, and general cognitive function', 'depressive symptoms, sleep quality and processing speed', 'Sleep quality and depression symptoms']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",116.0,0.141098,"The structured limbs-exercise program was beneficial for maintaining general cognitive function at 12 weeks (mean difference = 1.20, 95% CI [0.354, 2.054], p = 0.006) and at 24 weeks (mean difference = 1.59, 95% CI [0.722, 2.458], p = 0.001) in the intervention group.","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, Zhejiang 313000, China. Electronic address: aring2000@163.com.'}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Rory Meyers College of Nursing, New York University, New York, NY 10010, USA. Electronic address: bei.wu@nyu.edu.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Tao', 'Affiliation': 'AdventHealth Whole-Person Research, Orlando, FL 32804, USA. Electronic address: Hong.Tao@AdventHealth.com.'}, {'ForeName': 'Nannan', 'Initials': 'N', 'LastName': 'Chai', 'Affiliation': 'School of Nursing, Chifeng University, Chifeng, Inner Mongolia 024000, China. Electronic address: 151606873@qq.com.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, Zhejiang 313000, China. Electronic address: 17858368692@163.com.'}, {'ForeName': 'Xueting', 'Initials': 'X', 'LastName': 'Zhen', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, Zhejiang 313000, China. Electronic address: zhenxueting1029@163.com.'}, {'ForeName': 'Xianglian', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'School of Medicine, Huzhou University, Huzhou Central Hospital, Huzhou, Zhejiang 313000, China. Electronic address: 18777119676@163.com.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103706']
1799,32741240,A social dancing pilot intervention for older adults at high risk for Alzheimer's disease and related dementias.,"Close to 6 million older US adults have Alzheimer's disease or related dementias, yet there is currently no cure or effective treatment. This single-blind randomized controlled trial (clinicaltrials.gov: NCT03475316) aims to establish feasibility, and explore the relative efficacy, of a 6-month social ballroom dancing intervention versus a 6-month active control intervention (treadmill walking) for improving executive function in 32 older adults at increased risk for Alzheimer's disease or related dementias. Dementia-at-risk status is determined with cut-scores on the memory impairment screen (≥3 to ≤6) and/or the AD8 Dementia Screening Interview (≥1). The primary outcome is a composite executive function score from digit-symbol substitution, flanker interference and walking-while-talking tasks. The secondary outcome is functional neuroplasticity during fMRI-adapted versions of digit-symbol substitution, flanker interference and walking-while-talking.",2020,"Close to 6 million older US adults have Alzheimer's disease or related dementias, yet there is currently no cure or effective treatment.","[""older adults at high risk for Alzheimer's disease and related dementias"", ""32 older adults at increased risk for Alzheimer's disease or related dementias""]","['active control intervention (treadmill\xa0walking', 'social ballroom dancing intervention']","['composite executive function score from digit-symbol substitution, flanker interference and walking-while-talking tasks', 'functional neuroplasticity during fMRI-adapted versions of digit-symbol substitution, flanker interference and walking-while-talking']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0027880', 'cui_str': 'Plasticity, Neuronal'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",32.0,0.104066,"Close to 6 million older US adults have Alzheimer's disease or related dementias, yet there is currently no cure or effective treatment.","[{'ForeName': 'Helena M', 'Initials': 'HM', 'LastName': 'Blumen', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine, Bronx, NY\xa010461, USA.'}, {'ForeName': 'Emmeline', 'Initials': 'E', 'LastName': 'Ayers', 'Affiliation': 'Department of Neurology, Albert Einstein College of Medicine, Bronx, NY\xa010461, USA.'}, {'ForeName': 'Cuiling', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Albert Einstein College of Medicine, Bronx, NY\xa010461, USA.'}, {'ForeName': 'Anne F', 'Initials': 'AF', 'LastName': 'Ambrose', 'Affiliation': 'Department of Rehabilitation Medicine, Albert Einstein College of Medicine, Bronx, NY\xa010461, USA.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Verghese', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine, Bronx, NY\xa010461, USA.'}]",Neurodegenerative disease management,['10.2217/nmt-2020-0002']
1800,32746877,Chest physiotherapy improves lung aeration in hypersecretive critically ill patients: a pilot randomized physiological study.,"BACKGROUND


Besides airway suctioning, patients undergoing invasive mechanical ventilation (iMV) benefit of different combinations of chest physiotherapy techniques, to improve mucus removal. To date, little is known about the clearance effects of oscillating devices on patients with acute respiratory failure undergoing iMV. This study aimed to assess (1) the effects of high-frequency chest wall oscillation (HFCWO) on lung aeration and ventilation distribution, as assessed by electrical impedance tomography (EIT), and (2) the effect of the association of HFCWO with recruitment manoeuvres (RM).
METHODS


Sixty critically ill patients, 30 classified as normosecretive and 30 as hypersecretive, who received ≥ 48 h of iMV, underwent HFCWO; patients from both subgroups were randomized to receive RM or not, according to two separated randomization sequences. We therefore obtained four arms of 15 patients each. After baseline record (T0), HFCWO was applied for 10 min. At the end of the treatment (T1) or after 1 (T2) and 3 h (T3), EIT data were recorded. At the beginning of each step, closed tracheobronchial suctioning was performed. In the RM subgroup, tracheobronchial suctioning was followed by application of 30 cmH 2 O to the patient's airway for 30 s. At each step, we assessed the change in end-expiratory lung impedance (ΔEELI) and in tidal impedance variation (ΔTIV), and the center of gravity (COG) through EIT. We also analysed arterial blood gases (ABGs).
RESULTS


ΔTIV and COG did not differ between normosecretive and hypersecretive patients. Compared to T0, ΔEELI significantly increased in hypersecretive patients at T2 and T3, irrespective of the RM; on the contrary, no differences were observed in normosecretive patients. No differences of ABGs were recorded.
CONCLUSIONS


In hypersecretive patients, HFCWO significantly improved aeration of the dorsal lung region, without affecting ABGs. The application of RM did not provide any further improvements.
TRIAL REGISTRATION


Prospectively registered at the Australian New Zealand Clinical Trial Registry ( www.anzctr.org.au ; number of registration: ACTRN12615001257550; date of registration: 17th November 2015).",2020,"Compared to T0, ΔEELI significantly increased in hypersecretive patients at T2 and T3, irrespective of the RM; on the contrary, no differences were observed in normosecretive patients.","['hypersecretive critically ill patients', 'Sixty critically ill patients, 30 classified as normosecretive and 30 as hypersecretive, who received ≥\u200948\u2009h of iMV, underwent HFCWO; patients from both subgroups', '15 patients each', 'patients undergoing invasive mechanical ventilation (iMV', 'patients with acute respiratory failure undergoing iMV']","['Chest physiotherapy', 'tracheobronchial suctioning', 'RM', 'high-frequency chest wall oscillation (HFCWO']","['lung aeration', 'arterial blood gases (ABGs', 'aeration of the dorsal lung region', 'change in end-expiratory lung impedance (ΔEELI) and in tidal impedance variation (ΔTIV), and the center of gravity (COG) through EIT', 'ABGs', 'lung aeration and ventilation distribution']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C1136075', 'cui_str': 'High-Frequency Chest Compression'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}]","[{'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C0278385', 'cui_str': 'Tracheobronchial suctioning'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1136075', 'cui_str': 'High-Frequency Chest Compression'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282189', 'cui_str': 'Gravity'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}]",60.0,0.196393,"Compared to T0, ΔEELI significantly increased in hypersecretive patients at T2 and T3, irrespective of the RM; on the contrary, no differences were observed in normosecretive patients.","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Longhini', 'Affiliation': 'Anesthesia and Intensive Care Unit, Department of Medical and Surgical Sciences, University Hospital Mater Domini, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bruni', 'Affiliation': 'Anesthesia and Intensive Care Unit, Department of Medical and Surgical Sciences, University Hospital Mater Domini, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Garofalo', 'Affiliation': 'Anesthesia and Intensive Care Unit, Department of Medical and Surgical Sciences, University Hospital Mater Domini, Magna Graecia University, Catanzaro, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Ronco', 'Affiliation': ""Anesthesia and Intensive Care, Sant'Andrea Hospital, ASL VC, Vercelli, Italy.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Gusmano', 'Affiliation': ""Anesthesia and Intensive Care, Sant'Andrea Hospital, ASL VC, Vercelli, Italy.""}, {'ForeName': 'Gianmaria', 'Initials': 'G', 'LastName': 'Cammarota', 'Affiliation': 'Department of Anesthesia and Intensive Care, ""Maggiore della carità"" University Hospital, Novara, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pasin', 'Affiliation': 'Department of Anesthesia and Intensive Care, Azienda Ospedaliera-Università di Padova, Padua, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Frigerio', 'Affiliation': 'ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Chiumello', 'Affiliation': 'SC Anestesia e Rianimazione, Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Navalesi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Azienda Ospedaliera-Università di Padova, Padua, Italy. paolo.navalesi@unipd.it.'}]","Critical care (London, England)",['10.1186/s13054-020-03198-6']
1801,32747213,"Efficacy and safety of a live attenuated influenza vaccine in Chinese healthy children aged 3-17 years in one study center of a randomized, double-blind, placebo-controlled phase 3 clinical trial, 2016/17 season.","BACKGROUND


No data on the safety and efficacy of a live attenuated influenza vaccine in China have ever been reported.
METHODS


At a site of a phase 3 randomized, double-blind, placebo-controlled clinical trial in eastern China, eligible healthy children aged 3-17 years underwent randomization to receive live attenuated vaccine or placebo at a ratio of 1:1. The primary objective of the study was the prevention of laboratory-confirmed influenza illness during the surveillance period, starting on day 15 after vaccination.
RESULTS


A total of 2000 participants were enrolled, with 998 receiving the vaccine and 1001 receiving placebo. Sixty-four cases of influenza-like illness were observed, of which, 44 were laboratory-confirmed (12 in vaccine group versus 32 in placebo group). Vaccine efficacy was 62.5% (95%CI: 27.6-80.6) against all types of influenza and 63.3% (95%CI: 27.5-81.5) against influenza H3N2 illness. 11 severe adverse events reported (7 in LAIV group versus 4 in placebo group) were all deemed to be non-vaccine-related. Adverse events occurred in 412 (41.3%) participants in the vaccine group versus 389 (38.9%; p = 0.274) participants in the placebo group. Significant increase incidence of fever was observed in participants in the vaccine group, especially in those aged 3-9 years.
CONCLUSIONS


The live attenuated influenza vaccine showed good efficacy and safety among 3- to 17-year-olds children during the 2016-2017 season at a site in eastern China. Clinical Trial Registry Number: NCT02964065.",2020,Vaccine efficacy was 62.5% (95%CI: 27.6-80.6) against all types of influenza and 63.3% (95%CI: 27.5-81.5) against influenza H3N2 illness.,"['17-year-olds children during the 2016-2017 season at a site in eastern China', 'eastern China, eligible healthy children aged 3-17\xa0years underwent randomization to receive', 'Chinese healthy children aged 3-17\xa0years', '2000 participants were enrolled, with 998 receiving the vaccine and 1001 receiving']","['placebo', 'live attenuated vaccine or placebo', 'live attenuated influenza vaccine']","['11 severe adverse events', 'Adverse events', 'Vaccine efficacy', 'Efficacy and safety', 'efficacy and safety', 'incidence of fever']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3652556', 'cui_str': 'influenza, live attenuated'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",2000.0,0.738288,Vaccine efficacy was 62.5% (95%CI: 27.6-80.6) against all types of influenza and 63.3% (95%CI: 27.5-81.5) against influenza H3N2 illness.,"[{'ForeName': 'Shenyu', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, Zhejiang Province, China. Electronic address: sywang@cdc.zj.cn.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Chun'an County Center for Disease Control and Prevention, Hangzhou 311700, Zhejiang Province, China. Electronic address: 411035637@qq.com.""}, {'ForeName': 'Xiongyuan', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Changchun BCHT Biotechnology Co., Changchun 130012, Jilin Province, China. Electronic address: jinxiongyuan@bchtpharm.com.'}, {'ForeName': 'Zhengkai', 'Initials': 'Z', 'LastName': 'Gan', 'Affiliation': 'Xiuzhou District Center for Disease Control and Prevention, Jiaxing 314031, Zhejiang Province, China; Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, Zhejiang Province, China. Electronic address: ganzhengkai@163.com.'}, {'ForeName': 'Yanzhi', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': ""Chun'an County Center for Disease Control and Prevention, Hangzhou 311700, Zhejiang Province, China. Electronic address: 39630267@qq.com.""}, {'ForeName': 'Changlin', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Changchun BCHT Biotechnology Co., Changchun 130012, Jilin Province, China. Electronic address: zhuchanglin@bchtpharm.com.'}, {'ForeName': 'Xiaosong', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, Zhejiang Province, China. Electronic address: xshu@cdc.zj.cn.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, Zhejiang Province, China. Electronic address: zzliang@cdc.zj.cn.'}, {'ForeName': 'Yingping', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, Zhejiang Province, China. Electronic address: yingpchen@cdc.zj.cn.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xing', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, Zhejiang Province, China. Electronic address: bxing@cdc.zj.cn.'}, {'ForeName': 'Huakun', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': 'Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou 310051, Zhejiang Province, China. Electronic address: hklv@cdc.zj.cn.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Changchun BCHT Biotechnology Co., Changchun 130012, Jilin Province, China. Electronic address: xuna@bchtpharm.com.'}]",Vaccine,['10.1016/j.vaccine.2020.07.019']
1802,32749491,Effect of Long-term Vitamin D3 Supplementation vs Placebo on Risk of Depression or Clinically Relevant Depressive Symptoms and on Change in Mood Scores: A Randomized Clinical Trial.,"Importance


Low levels of 25-hydroxyvitamin D have been associated with higher risk for depression later in life, but there have been few long-term, high-dose large-scale trials.
Objective


To test the effects of vitamin D3 supplementation on late-life depression risk and mood scores.
Design, Setting, and Participants


There were 18 353 men and women aged 50 years or older in the VITAL-DEP (Vitamin D and Omega-3 Trial-Depression Endpoint Prevention) ancillary study to VITAL, a randomized clinical trial of cardiovascular disease and cancer prevention among 25 871 adults in the US. There were 16 657 at risk for incident depression (ie, no depression history) and 1696 at risk for recurrent depression (ie, depression history but no treatment for depression within the past 2 years). Randomization occurred from November 2011 through March 2014; randomized treatment ended on December 31, 2017, and this was the final date of follow-up.
Intervention


Randomized assignment in a 2 × 2 factorial design to vitamin D3 (2000 IU/d of cholecalciferol) and fish oil or placebo; 9181 were randomized to vitamin D3 and 9172 were randomized to matching placebo.
Main Outcomes and Measures


The primary outcomes were the risk of depression or clinically relevant depressive symptoms (total of incident and recurrent cases) and the mean difference in mood scores (8-item Patient Health Questionnaire depression scale [PHQ-8]; score range, 0 points [least symptoms] to 24 points [most symptoms]; the minimal clinically important difference for change in scores was 0.5 points).
Results


Among the 18 353 randomized participants (mean age, 67.5 [SD, 7.1] years; 49.2% women), the median treatment duration was 5.3 years and 90.5% completed the trial (93.5% among those alive at the end of the trial). Risk of depression or clinically relevant depressive symptoms was not significantly different between the vitamin D3 group (609 depression or clinically relevant depressive symptom events; 12.9/1000 person-years) and the placebo group (625 depression or clinically relevant depressive symptom events; 13.3/1000 person-years) (hazard ratio, 0.97 [95% CI, 0.87 to 1.09]; P = .62); there were no significant differences between groups in depression incidence or recurrence. No significant differences were observed between treatment groups for change in mood scores over time; mean change in PHQ-8 score was not significantly different from zero (mean difference for change in mood scores, 0.01 points [95% CI, -0.04 to 0.05 points]).
Conclusions and Relevance


Among adults aged 50 years or older without clinically relevant depressive symptoms at baseline, treatment with vitamin D3 compared with placebo did not result in a statistically significant difference in the incidence and recurrence of depression or clinically relevant depressive symptoms or for change in mood scores over a median follow-up of 5.3 years. These findings do not support the use of vitamin D3 in adults to prevent depression.
Trial Registration


ClinicalTrials.gov Identifiers: NCT01169259 and NCT01696435.",2020,"No significant differences were observed between treatment groups for change in mood scores over time; mean change in PHQ-8 score was not significantly different from zero (mean difference for change in mood scores, 0.01 points [95% CI, -0.04 to 0.05 points]).
","['Among the 18\u202f353 randomized participants (mean age, 67.5 [SD, 7.1] years; 49.2% women', 'Participants\n\n\nThere were 18\u202f353 men and women aged 50 years or older in the VITAL-DEP (Vitamin D and Omega-3 Trial-Depression Endpoint Prevention) ancillary study to VITAL, a randomized clinical trial of cardiovascular disease and cancer prevention among 25\u202f871 adults in the US', 'adults aged 50 years or older without clinically', 'There were 16\u202f657 at risk for incident depression (ie, no depression history) and 1696 at risk for recurrent depression (ie, depression history but no treatment for depression within the past 2 years']","['Long-term Vitamin D3 Supplementation vs Placebo', '25-hydroxyvitamin D', 'vitamin D3 supplementation', 'vitamin D3 (2000 IU/d of cholecalciferol) and fish oil or placebo', 'vitamin D3', 'placebo']","['relevant depressive symptoms', 'late-life depression risk and mood scores', 'Risk of depression or clinically relevant depressive symptoms', 'depression incidence or recurrence', 'Risk of Depression or Clinically Relevant Depressive Symptoms', 'mood scores', 'risk of depression or clinically relevant depressive symptoms (total of incident and recurrent cases) and the mean difference in mood scores (8-item Patient Health Questionnaire depression scale [PHQ-8]; score range, 0 points [least symptoms', 'median treatment duration', 'Mood Scores', 'incidence and recurrence of depression or clinically relevant depressive symptoms', 'PHQ-8 score']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0057472', 'cui_str': '1-(2-(dodecyloxy)ethyl)pyrrolidine hydrochloride'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0221480', 'cui_str': 'Recurrent depression'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444637', 'cui_str': 'Past'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}]",25871.0,0.741621,"No significant differences were observed between treatment groups for change in mood scores over time; mean change in PHQ-8 score was not significantly different from zero (mean difference for change in mood scores, 0.01 points [95% CI, -0.04 to 0.05 points]).
","[{'ForeName': 'Olivia I', 'Initials': 'OI', 'LastName': 'Okereke', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'Department of Psychiatry, UPMC and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mischoulon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, VA Boston Healthcare System, Brockton, Massachusetts.'}, {'ForeName': 'Chirag M', 'Initials': 'CM', 'LastName': 'Vyas', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston.'}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': 'Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Weinberg', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Vadim', 'Initials': 'V', 'LastName': 'Bubes', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Copeland', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Friedenberg', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': 'Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': 'Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}]",JAMA,['10.1001/jama.2020.10224']
1803,32745667,Relationships between rectal and perirectal doses and rectal bleeding or tenesmus in pooled voxel-based analysis of 3 randomised phase III trials.,"BACKGROUND AND PURPOSE


This study aimed to identify anatomically-localised regions where planned radiotherapy dose is associated with gastrointestinal toxicities in healthy tissues throughout the pelvic anatomy.
MATERIALS AND METHODS


Planned dose distributions for up to 657 patients of the Trans Tasman Radiation Oncology Group 03.04 RADAR trial were deformably registered onto a single exemplar computed tomography dataset. Voxel-based multiple comparison permutation dose difference testing, Cox regression modelling and LASSO feature selection were used to identify regions where dose-increase was associated with grade ≥2 rectal bleeding (RB) or tenesmus, according to the LENT/SOMA scale. This was externally validated by registering dose distributions from the RT01 (n = 388) and CHHiP (n = 241) trials onto the same exemplar and repeating the tests on each of these data sets, and on all three datasets combined.
RESULTS


Voxel-based Cox regression and permutation dose difference testing revealed regions where increased dose was correlated with gastrointestinal toxicity. Grade ≥2 RB was associated with posteriorly extended lateral beams that manifested high doses (>55 Gy) in a small rectal volume adjacent to the clinical target volume. A correlation was found between grade ≥2 tenesmus and increased low-intermediate dose (∼25 Gy) at the posterior beam region, including the posterior rectum and perirectal fat space (PRFS).
CONCLUSIONS


The serial response of the rectum with respect to RB has been demonstrated in patients with posteriorly extended lateral beams. Similarly, the parallel response of the PRFS with respect to tenesmus has been demonstrated in patients treated with the posterior beam.",2020,"A correlation was found between grade≥2 tenesmus and increased low-intermediate dose (∼25 Gy) at the posterior beam region, including the posterior rectum and perirectal fat space (PRFS).
","['patients with posteriorly extended lateral beams', '657 patients of the Trans Tasman Radiation Oncology Group 03.04 RADAR trial were deformably registered onto a single exemplar computed tomography dataset']",[],"['grade≥2 rectal bleeding (RB) or tenesmus', 'gastrointestinal toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0243005', 'cui_str': 'Radiation oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034513', 'cui_str': 'Radar'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]",[],"[{'cui': 'C0018932', 'cui_str': 'Hematochezia'}, {'cui': 'C0232726', 'cui_str': 'Rectal tenesmus'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}]",,0.0350618,"A correlation was found between grade≥2 tenesmus and increased low-intermediate dose (∼25 Gy) at the posterior beam region, including the posterior rectum and perirectal fat space (PRFS).
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Marcello', 'Affiliation': 'Department of Physics, University of Western Australia, Crawley, Australia; Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia. Electronic address: 20739859@student.uwa.edu.au.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Denham', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Kennedy', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haworth', 'Affiliation': 'School of Physics, University of Sydney, Camperdown, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Steigler', 'Affiliation': 'Prostate Cancer Trials Group, School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Greer', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Callaghan, Australia; Department of Radiation Oncology, Calvary Mater Newcastle, Waratah, Australia.'}, {'ForeName': 'Lois C', 'Initials': 'LC', 'LastName': 'Holloway', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Australia; South Western Sydney Clinical School, University of New South Wales, Liverpool, Australia; Centre for Medical Radiation Physics, University of Wollongong, Australia.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Dowling', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Callaghan, Australia; CSIRO, Herston, Australia.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Jameson', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Australia; South Western Sydney Clinical School, University of New South Wales, Liverpool, Australia; Centre for Medical Radiation Physics, University of Wollongong, Australia; Cancer Research Team, Ingham Institute for Applied Medical Research, Liverpool, Australia.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Roach', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Australia; South Western Sydney Clinical School, University of New South Wales, Liverpool, Australia; Cancer Research Team, Ingham Institute for Applied Medical Research, Liverpool, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': 'School of Surgery, University of Western Australia, Crawley, Australia; 5D Clinics, Claremont, Australia; GenesisCare WA, Wembley, Australia.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Gulliford', 'Affiliation': 'Radiotherapy Department, University College London Hospitals NHS Foundation Trust, United Kingdom; Department of Medical Physics and Biomedical Engineering, University College London, United Kingdom.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'Academic UroOncology Unit, The Institute of Cancer Research and the Royal Marsden NHS Trust, London, Australia.'}, {'ForeName': 'Mathew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, United Kingdom.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Ebert', 'Affiliation': 'Department of Physics, University of Western Australia, Crawley, Australia; Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia; 5D Clinics, Claremont, Australia.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.07.048']
1804,32746730,Improving parent-child interactions in maltreating families with the Attachment Video-feedback Intervention: Parental childhood trauma as a moderator of treatment effects.,"Research is demonstrating the effectiveness of attachment-based interventions for maltreating families. However, parents' own traumatic childhood experiences may interfere with treatment effects. The current study investigated in a sample of maltreating families whether effects of the Attachment Video-feedback Intervention (AVI) on parent-child interactive quality were moderated by parental childhood trauma. Families were randomized to receive AVI ( n  = 29) or a Psychoeducative intervention (PI;  n  = 19), or they were in anon-randomized comparison group (RS;  n  = 40). Parents filled out the Childhood Trauma Questionnaire and videotapes of parent-child interactions were coded for interactive quality. Parents who received AVI showed improved parent-child interactive quality compared to parents in PI and RS groups. However, parents with more severe levels of childhood trauma showed less improvements. Future research should explore whether clinical attention with a specific focus on trauma would increase treatement effects.",2020,Parents who received AVI showed improved parent-child interactive quality compared to parents in PI and RS groups.,[],"['Attachment Video-feedback Intervention (AVI', 'AVI', 'Psychoeducative intervention']","['parent-child interactive quality', 'Childhood Trauma Questionnaire and videotapes of parent-child interactions']",[],"[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",,0.0424963,Parents who received AVI showed improved parent-child interactive quality compared to parents in PI and RS groups.,"[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'van der Asdonk', 'Affiliation': 'Institute of Education and Child Studies, Leiden University , Leiden, the Netherlands.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Cyr', 'Affiliation': 'Université du Québec à Montréal , Montréal, Canada.'}, {'ForeName': 'Lenneke', 'Initials': 'L', 'LastName': 'Alink', 'Affiliation': 'Institute of Education and Child Studies, Leiden University , Leiden, the Netherlands.'}]",Attachment & human development,['10.1080/14616734.2020.1799047']
1805,32750332,The effect of oxytocin on pupil response to naturalistic dynamic facial expressions.,"The neuropeptide oxytocin (OT) has been found to play an important role in a variety of social behaviours and social cognition in particular. The social salience hypothesis of OT suggests that OT shifts attention towards socially relevant stimuli, which offers an explanation for improvements on social cognition measures following OT administration. Pupil dilation occurs with increasing attentional resource allocation and previous research has found that OT administration led to an increase in pupil diameter in response to social stimuli relative to placebo (PL), thereby suggesting increased social attention. The current study aimed to investigate the effects of OT on pupillary responses to more naturalistic social stimuli in a larger sample. Ninety-four male participants took part in the double-blind, placebo controlled, mixed-design study, in which they self-administered either an OT or PL nasal spray before viewing naturalistic dynamic facial expressions of emotion (happy, sad, fear and anger). Contrary to prediction, there was no effect of OT administration on pupil diameter. The results are discussed in light of the social salience hypothesis and with reference to the methodological differences between studies.",2020,"Pupil dilation occurs with increasing attentional resource allocation and previous research has found that OT administration led to an increase in pupil diameter in response to social stimuli relative to placebo (PL), thereby suggesting increased social attention.",['Ninety-four male participants took part in the double-blind'],"['OT', 'oxytocin', 'OT or PL nasal spray', 'neuropeptide oxytocin (OT', 'placebo']","['social cognition measures', 'pupil response to naturalistic dynamic facial expressions', 'emotion (happy, sad, fear and anger']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0461725', 'cui_str': 'Nasal spray'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0085159', 'cui_str': 'Seasonal affective disorder'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]",94.0,0.0408089,"Pupil dilation occurs with increasing attentional resource allocation and previous research has found that OT administration led to an increase in pupil diameter in response to social stimuli relative to placebo (PL), thereby suggesting increased social attention.","[{'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Burley', 'Affiliation': 'Cardiff University Centre for Human Developmental Science, School of Psychology, Cardiff University, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Daughters', 'Affiliation': 'Neuroscience and Mental Health Research Institute, Cardiff University, United Kingdom of Great Britain and Northern Ireland. Electronic address: k.daughters@essex.ac.uk.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104837']
1806,32750760,"Efficacy of Buspirone Augmentation of Escitalopram in Patients with Major Depressive Disorder with and without Atypical Features: A Randomized, 8 Week, Multicenter, Open-Label Clinical Trial.","OBJECTIVE


This study investigated the treatment response and cognitive enhancement effects of buspirone augmentation of escitalopram in patients with major depressive disorder (MDD), according to atypical feature subtypes of MDD.
METHODS


An 8 week, randomized, parallel-controlled, open-label study was conducted. The Columbia Atypical Depression Diagnostic Scale was administered to evaluate atypical features. Patients were assigned randomly to the buspirone augmentation or non-buspirone groups. Symptom severity and cognitive function were evaluated using the 17-item Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Beck Depression Inventory, Beck Anxiety Inventory, digit span test, word fluency test, and Trail Making Tests A and B.
RESULTS


A total of 89 patients were recruited. There were no significant differences in the measures between the groups; however, among the MDD patients without atypical features, the digit span and word fluency tests were improved by treatment. In the MDD patients without atypical features, the buspirone augmentation group showed a significant improvement on the digit span test compared to the non-buspirone group.
CONCLUSION


Buspirone augmentation did not demonstrate significant benefits in MDD patients; however, buspirone augmentation showed greater efficacy for the improvement of cognitive function in MDD patients without atypical features. Our study suggests that atypical features are an important factor for cognitive enhancement in buspirone augmentation treatment in patients with MDD.",2020,"In the MDD patients without atypical features, the buspirone augmentation group showed a significant improvement on the digit span test compared to the non-buspirone group.
","['MDD patients', 'patients with MDD', 'patients with major depressive disorder (MDD', 'A total of 89 patients were recruited', 'Patients with Major Depressive Disorder with and without Atypical Features']","['buspirone augmentation of escitalopram', 'Buspirone Augmentation of Escitalopram', 'buspirone augmentation or non-buspirone']","['digit span and word fluency tests', 'cognitive function', 'Symptom severity and cognitive function', 'digit span test', '17-item Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Beck Depression Inventory, Beck Anxiety Inventory, digit span test, word fluency test, and Trail Making Tests A and B', 'Columbia Atypical Depression Diagnostic Scale']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}]","[{'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0154437', 'cui_str': 'Atypical depressive disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",89.0,0.0151867,"In the MDD patients without atypical features, the buspirone augmentation group showed a significant improvement on the digit span test compared to the non-buspirone group.
","[{'ForeName': 'Cheolmin', 'Initials': 'C', 'LastName': 'Shin', 'Affiliation': 'Department of Psychiatry, Korea University College of Medicine, Korea University Ansan Hospital, Ansan, Republic of Korea.'}, {'ForeName': 'Young-Hoon', 'Initials': 'YH', 'LastName': 'Ko', 'Affiliation': 'Department of Psychiatry, Korea University College of Medicine, Korea University Ansan Hospital, Ansan, Republic of Korea.'}, {'ForeName': 'Se-Hoon', 'Initials': 'SH', 'LastName': 'Shim', 'Affiliation': 'Department of Psychiatry, Soonchunhyang University College of Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Republic of Korea.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Soonchunhyang University College of Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Republic of Korea.'}, {'ForeName': 'Kyoung-Sae', 'Initials': 'KS', 'LastName': 'Na', 'Affiliation': 'Department of Psychiatry, Gachon University College of Medicine, Gil Medical Center, Incheon, Republic of Korea.'}, {'ForeName': 'Sang-Woo', 'Initials': 'SW', 'LastName': 'Hahn', 'Affiliation': 'Department of Psychiatry, Soonchunhyang University College of Medicine, Soonchunhyang University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Seung-Hwan', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Inje University Ilsan Paik Hospital, Goyang, Republic of Korea.'}]",Psychiatry investigation,['10.30773/pi.2020.0017']
1807,32753452,FIRST-line support for assistance in breathing in children (FIRST-ABC): a master protocol of two randomised trials to evaluate the non-inferiority of high-flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in paediatric critical care.,"INTRODUCTION


Even though respiratory support is a common intervention in paediatric critical care, there is no randomised controlled trial (RCT) evidence regarding the effectiveness of two commonly used modes of non-invasive respiratory support (NRS), continuous positive airway pressure (CPAP) and high-flow nasal cannula therapy (HFNC). FIRST-line support for assistance in breathing in children is a master protocol of two pragmatic non-inferiority RCTs to evaluate the clinical and cost-effectiveness of HFNC (compared with CPAP) as the first-line mode of support in critically ill children.
METHODS AND ANALYSIS


We will recruit participants over a 30-month period at 25 UK paediatric critical care units (paediatric intensive care units/high-dependency units). Patients are eligible if admitted/accepted for admission, aged >36 weeks corrected gestational age and <16 years, and assessed by the treating clinician to require NRS for an acute illness (step-up RCT) or within 72 hours of extubation following a period of invasive ventilation (step-down RCT). Due to the emergency nature of the treatment, written informed consent will be deferred to after randomisation. Randomisation will occur 1:1 to CPAP or HFNC, stratified by site and age (<12 vs ≥12 months). The primary outcome is time to liberation from respiratory support for a continuous period of 48 hours. A total sample size of 600 patients in each RCT will provide 90% power with a type I error rate of 2.5% (one sided) to exclude the prespecified non-inferiority margin of HR of 0.75. Primary analyses will be undertaken separately in each RCT in both the intention-to-treat and per-protocol populations.
ETHICS AND DISSEMINATION


This master protocol received favourable ethical opinion from National Health Service East of England-Cambridge South Research Ethics Committee (reference: 19/EE/0185) and approval from the Health Research Authority (reference: 260536). Results will be disseminated via publications in peer-reviewed medical journals and presentations at national and international conferences.
TRIAL REGISTRATION NUMBER


ISRCTN60048867.",2020,"Randomisation will occur 1:1 to CPAP or HFNC, stratified by site and age (<12 vs ≥12 months).","['600 patients in each', 'participants over a 30-month period at 25 UK paediatric critical care units (paediatric intensive care units/high-dependency units', 'Patients are eligible if admitted/accepted for admission, aged >36 weeks corrected gestational age and <16 years, and assessed by the treating clinician to require NRS for an acute illness (step-up RCT) or within 72\u2009hours of extubation following a period of invasive ventilation (step-down RCT', 'critically ill children']","['RCT', 'FIRST-line support', 'high-flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP', 'HFNC']",['time to liberation from respiratory support for a continuous period of 48\u2009hours'],"[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C1627345', 'cui_str': 'Stepdown unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439586', 'cui_str': '48 hours'}]",,0.253144,"Randomisation will occur 1:1 to CPAP or HFNC, stratified by site and age (<12 vs ≥12 months).","[{'ForeName': 'Alvin', 'Initials': 'A', 'LastName': 'Richards-Belle', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Davis', 'Affiliation': 'Paediatric Intensive Care, Bristol Royal Hospital for Children, Bristol, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Drikite', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Feltbower', 'Affiliation': 'Leeds Institute for Data Analytics, University of Leeds, Leeds, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Grieve', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Harrison', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lester', 'Affiliation': 'Parent representative, Sussex, UK.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Morris', 'Affiliation': ""Paediatric Intensive Care Unit, Birmingham Women's and Children's Hospitals NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Paul R', 'Initials': 'PR', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Peters', 'Affiliation': 'Paediatric Intensive Care Unit, Great Ormond Street Hospital For Children NHS Trust, London, UK.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Rowan', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.'}, {'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Sadique', 'Affiliation': 'Department of Health Services Research and Policy, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Lyvonne N', 'Initials': 'LN', 'LastName': 'Tume', 'Affiliation': 'School of Health and Society, University of Salford, Salford, Greater Manchester, UK.'}, {'ForeName': 'Padmanabhan', 'Initials': 'P', 'LastName': 'Ramnarayan', 'Affiliation': ""Children's Acute Transport Service, Great Ormond Street Hospital For Children NHS Trust, London, UK p.ramnarayan@gosh.nhs.uk.""}]",BMJ open,['10.1136/bmjopen-2020-038002']
1808,32753545,Tumor infiltrating lymphocytes (TIL) therapy in metastatic melanoma: boosting of neoantigen-specific T cell reactivity and long-term follow-up.,"Treatment of metastatic melanoma with autologous tumor infiltrating lymphocytes (TILs) is currently applied in several centers. Robust and remarkably consistent overall response rates, of around 50% of treated patients, have been observed across hospitals, including a substantial fraction of durable, complete responses.
PURPOSE


Execute a phase I/II feasibility study with TIL therapy in metastatic melanoma at the Netherlands Cancer Institute, with the goal to assess feasibility and potential value of a randomized phase III trial.
EXPERIMENTAL


Ten patients were treated with TIL therapy. Infusion products and peripheral blood samples were phenotypically characterized and neoantigen reactivity was assessed. Here, we present long-term clinical outcome and translational data on neoantigen reactivity of the T cell products.
RESULTS


Five out of 10 patients, who were all anti-PD-1 naïve at time of treatment, showed an objective clinical response, including two patients with a complete response that are both ongoing for more than 7 years. Immune monitoring demonstrated that neoantigen-specific T cells were detectable in TIL infusion products from three out of three patients analyzed. For six out of the nine neoantigen-specific T cell responses detected in these TIL products, T cell response magnitude increased significantly in the peripheral blood compartment after therapy, and neoantigen-specific T cells were detectable for up to 3 years after TIL infusion.
CONCLUSION


The clinical results from this study confirm the robustness of TIL therapy in metastatic melanoma and the potential role of neoantigen-specific T cell reactivity. In addition, the data from this study supported the rationale to initiate an ongoing multicenter phase III TIL trial.",2020,Immune monitoring demonstrated that neoantigen-specific T cells were detectable in TIL infusion products from three out of three patients analyzed.,"['metastatic melanoma', 'metastatic melanoma at the Netherlands Cancer Institute', 'metastatic melanoma with autologous tumor infiltrating lymphocytes (TILs']",['TIL therapy'],"['neoantigen-specific T cells', 'overall response rates']","[{'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}]","[{'cui': 'C0280661', 'cui_str': 'TIL therapy'}]","[{'cui': 'C0312555', 'cui_str': 'Neoantigen'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",2.0,0.0473248,Immune monitoring demonstrated that neoantigen-specific T cells were detectable in TIL infusion products from three out of three patients analyzed.,"[{'ForeName': 'Joost H', 'Initials': 'JH', 'LastName': 'van den Berg', 'Affiliation': 'BioTherapeutics Unit, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Heemskerk', 'Affiliation': 'Division of Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'van Rooij', 'Affiliation': 'Division of Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Gomez-Eerland', 'Affiliation': 'Division of Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Michels', 'Affiliation': 'Division of Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'van Zon', 'Affiliation': 'BioTherapeutics Unit, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'de Boer', 'Affiliation': 'BioTherapeutics Unit, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Noor A M', 'Initials': 'NAM', 'LastName': 'Bakker', 'Affiliation': 'BioTherapeutics Unit, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Jorritsma-Smit', 'Affiliation': 'Division of Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Marit M', 'Initials': 'MM', 'LastName': 'van Buuren', 'Affiliation': 'Division of Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Kvistborg', 'Affiliation': 'Division of Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Hergen', 'Initials': 'H', 'LastName': 'Spits', 'Affiliation': 'AIMM Therapeutics, Amsterdam, The Netherlands.'}, {'ForeName': 'Remko', 'Initials': 'R', 'LastName': 'Schotte', 'Affiliation': 'AIMM Therapeutics, Amsterdam, The Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Mallo', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Karger', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Joris A', 'Initials': 'JA', 'LastName': 'van der Hage', 'Affiliation': 'Department of Surgery, Leiden Universitair Medisch Centrum, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Michel W J M', 'Initials': 'MWJM', 'LastName': 'Wouters', 'Affiliation': 'Surgical Oncology, Antoni van Leeuwenhoek Nederlands Kanker Instituut, Amsterdam, The Netherlands.'}, {'ForeName': 'Loes M', 'Initials': 'LM', 'LastName': 'Pronk', 'Affiliation': 'Department of Biometrics, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Marnix H', 'Initials': 'MH', 'LastName': 'Geukes Foppen', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Jos H', 'Initials': 'JH', 'LastName': 'Beijnen', 'Affiliation': 'Department of Pharmacy & Pharmacology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Bastiaan', 'Initials': 'B', 'LastName': 'Nuijen', 'Affiliation': 'Department of Pharmacy & Pharmacology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Ton N', 'Initials': 'TN', 'LastName': 'Schumacher', 'Affiliation': 'Division of Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'John B A G', 'Initials': 'JBAG', 'LastName': 'Haanen', 'Affiliation': 'Division of Molecular Oncology and Immunology, Netherlands Cancer Institute, Amsterdam, The Netherlands j.haanen@nki.nl.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000848']
1809,32763217,"Simplified dolutegravir dosing for children with HIV weighing 20 kg or more: pharmacokinetic and safety substudies of the multicentre, randomised ODYSSEY trial.","BACKGROUND


Paediatric dolutegravir doses approved by stringent regulatory authorities (SRAs) for children weighing 20 kg to less than 40 kg until recently required 25 mg and 10 mg film-coated tablets. These tablets are not readily available in low-resource settings where the burden of HIV is highest. We did nested pharmacokinetic substudies in patients enrolled in the ODYSSEY-trial to evaluate simplified dosing in children with HIV.
METHODS


We did pharmacokinetic and safety substudies within the open-label, multicentre, randomised ODYSSEY trial (NCT02259127) of children with HIV starting treatment in four research centres in Uganda and Zimbabwe. Eligible children were randomised to dolutegravir in ODYSSEY and weighed 20 kg to less than 40 kg. In children weighing 20 kg to less than 25 kg, we assessed dolutegravir's pharmacokinetics in children given once daily 25 mg film-coated tablets (approved by the SRAs at the time of the study) in part one of the study, and 50 mg film-coated tablets (adult dose) or 30 mg dispersible tablets in part two of the study. In children weighing 25 kg to less than 40 kg, we also assessed dolutegravir pharmacokinetics within-subject on film-coated tablet doses of 25 mg or 35 mg once daily, which were approved by the SRAs for the children's weight band; then switched to 50 mg film-coated tablets once daily. Steady-state 24 h dolutegravir plasma concentration-time pharmacokinetic profiling was done in all enrolled children at baseline and 1, 2, 3, 4, 6, and 24 h after observed dolutegravir intake. Target dolutegravir trough concentrations (C trough ) were based on reference adult pharmacokinetic data and safety was evaluated in all children in the corresponding weight bands who consented to pharmacokinetic studies and received the studied doses.
FINDINGS


Between Sept 22, 2016, and May 31, 2018, we enrolled 62 black-African children aged from 6 years to younger than 18 years (84 pharmacokinetic-profiles). In children weighing 20 kg to less than 25 kg taking 25 mg film-coated tablets, the geometric mean (GM) C trough  (coefficient of variation) was 0·32 mg/L (94%), which was 61% lower than the GM C trough  of 0·83 mg/L (26%) in fasted adults on dolutegravir 50 mg once-daily; in children weighing 25 kg to less than 30 kg taking 25 mg film-coated tablets, the GM C trough  was 0·39 mg/L (48%), which was 54% lower than the GM C trough  in fasted adults; and in those 30 kg to less than 40 kg taking 35 mg film-coated tablets the GM C trough  was 0·46 mg/L (63%), which was 45% lower than the GM C trough  in fasted adults. On 50 mg film-coated tablets or 30 mg dispersible tablets, C trough  was close to the adult reference (with similar estimates on the two formulations in children in the 20 to <25 kg weight band), with total exposure (area under the concentration-time curve from 0 h to 24 h) in between reference values in adults dosed once and twice daily, where safety data are reassuring, although maximum concentrations were higher in children weighing 20 kg to less than 25 kg than in the twice-daily adult reference. Over a 24-week follow-up period in 47 children on 30 mg dispersible tablets or 50 mg film-coated tablets, none of the three reported adverse events (cryptococcal meningitis, asymptomatic anaemia, and asymptomatic neutropenia) were considered related to dolutegravir.
INTERPRETATION


Adult dolutegravir 50 mg film-coated tablets given once daily provide appropriate pharmacokinetic profiles in children weighing 20 kg or more, with no safety signal, allowing simplified practical dosing and rapid access to dolutegravir. These results informed the WHO 2019 dolutegravir paediatric dosing guidelines and have led to US Food and Drug Administration approval of adult dosing down to 20 kg.
FUNDING


Paediatric European Network for Treatment of AIDS Foundation, ViiV Healthcare, UK Medical Research Council.",2020,"In children weighing 20 kg to less than 25 kg taking 25 mg film-coated tablets, the geometric mean (GM) C trough  (coefficient of variation) was 0·32","['62 black-African children aged from 6 years to younger than 18 years (84 pharmacokinetic-profiles', 'children with HIV weighing 20 kg or more', '47 children', 'Between Sept 22, 2016, and May 31, 2018', 'patients enrolled in the ODYSSEY-trial to evaluate simplified dosing in children with HIV', 'Eligible children', 'children with HIV starting treatment in four research centres in Uganda and Zimbabwe']",[],"[""dolutegravir's pharmacokinetics"", 'dolutegravir pharmacokinetics', 'adverse events (cryptococcal meningitis, asymptomatic anaemia, and asymptomatic neutropenia']","[{'cui': 'C0337824', 'cui_str': 'Black African'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}]",[],"[{'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085436', 'cui_str': 'Cryptococcal meningitis'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",62.0,0.226703,"In children weighing 20 kg to less than 25 kg taking 25 mg film-coated tablets, the geometric mean (GM) C trough  (coefficient of variation) was 0·32","[{'ForeName': 'Pauline D J', 'Initials': 'PDJ', 'LastName': 'Bollen', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': 'Cecilia L', 'Initials': 'CL', 'LastName': 'Moore', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Hilda A', 'Initials': 'HA', 'LastName': 'Mujuru', 'Affiliation': 'University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Shafic', 'Initials': 'S', 'LastName': 'Makumbi', 'Affiliation': 'Joint Clinical Research Centre, Mbarara, Uganda.'}, {'ForeName': 'Adeodata R', 'Initials': 'AR', 'LastName': 'Kekitiinwa', 'Affiliation': ""Baylor College of Medicine Children's Foundation, Kampala, Uganda.""}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kaudha', 'Affiliation': 'Joint Clinical Research Centre, Kampala, Uganda.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Parker', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Musoro', 'Affiliation': 'University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Annet', 'Initials': 'A', 'LastName': 'Nanduudu', 'Affiliation': 'Joint Clinical Research Centre, Kampala, Uganda.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Lugemwa', 'Affiliation': 'Joint Clinical Research Centre, Mbarara, Uganda.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Amuge', 'Affiliation': ""Baylor College of Medicine Children's Foundation, Kampala, Uganda.""}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Hakim', 'Affiliation': 'University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Rojo', 'Affiliation': 'Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Giaquinto', 'Affiliation': 'University of Padova, Padova, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Colbers', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands. Electronic address: angela.colbers@radboudumc.nl.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Gibb', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Ford', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Turkova', 'Affiliation': 'Medical Research Council Clinical Trials Unit, University College London, London, UK.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Burger', 'Affiliation': 'Department of Pharmacy, Radboud Institute for Health Sciences, Radboud university medical center, Nijmegen, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30189-2']
1810,32763218,Rapid antiretroviral therapy initiation in the Botswana Combination Prevention Project: a quasi-experimental before and after study.,"BACKGROUND


Ensuring that individuals who are living with HIV rapidly initiate antiretroviral therapy (ART) is an essential step in meeting the 90-90-90 targets. We evaluated the feasibility and outcomes of rapid ART initiation in the Botswana Combination Prevention Project (BCPP). We aimed to establish whether simplified ART initiation with the offer of same-day treatment could increase uptake and reduce time from clinic linkage to treatment initiation, while maintaining rates of retention in care and viral suppression.
METHODS


We did a quasi-experimental before and after study with use of data from the BCPP. The BCPP was a community-randomised HIV-prevention trial done in 30 communities across Botswana from Oct 1, 2013, to June 30, 2018. Participants in the 15 intervention clusters, who were HIV-positive and not already taking ART were offered universal HIV-treatment and same-day ART with a dolutegravir-based regimen at first clinic visit. This rapid ART intervention was implemented mid-way through the trial on June 1, 2016, enabling us to determine the effect of rapid ART guidelines on time to ART initiation and rates of retention in care and viral suppression at 1 year in the BCPP intervention group.
FINDINGS


We assessed 1717 adults linked to study clinics before rapid ART introduction and 800 after rapid ART introduction. During the rapid ART period, 457 (57·1%, 95% CI 53·7-60·6) individuals initiated ART within 1 day of linkage, 589 (73·7%, 70·6-76·7) of 799 within 1 week, 678 (84·9%, 82·4-87·3) of 799 within 1 month, and 744 (93·5%, 91·6-95·1) of 796 within 1 year. Before the introduction of rapid ART, 163 (9·5%, 95% CI 8·2-11·0) individuals initiated ART within 1 day of linkage, 276 (16·1%, 14·4-17·9) within 1 week, 839 (48·9%, 46·5-51·3) within 1 month, and 1532 (89·2%, 87·7-90·6) within 1 year. 1 year after ART initiation, 1472 (90·5%, 87·4-92·8) of 1627 individuals who linked in the standard ART period were in care and had a viral load of less than 400 copies per mL, compared with 578 (91·6%, 88·1-94·1) of 631 in the rapid ART period (risk ratio 1·01, 95% CI 0·92-1·11).
INTERPRETATION


Our findings provide support for the WHO recommendations for rapid ART initiation, and add to the accumulating evidence showing the feasibility, acceptability, and safety of rapid ART initiation in low-income and middle-income country settings.
FUNDING


US President's Emergency Plan for AIDS Relief.",2020,"1 year after ART initiation, 1472 (90·5%, 87·4-92·8) of 1627 individuals who linked in the standard ART period were in care and had a viral load of less than 400 copies per mL, compared with 578 (91·6%, 88·1-94·1) of 631 in the rapid ART period (risk ratio 1·01, 95% CI 0·92-1·11).
","['30 communities across Botswana from Oct 1, 2013, to June 30, 2018', 'individuals who are living with HIV rapidly initiate antiretroviral therapy (ART', '1717 adults linked to study clinics before rapid ART introduction and 800 after rapid ART introduction', 'Participants in the 15 intervention clusters, who were HIV-positive and not already taking ART were offered universal HIV-treatment and same-day ART with a dolutegravir-based regimen at first clinic visit']",[],['time to ART initiation and rates of retention in care and viral suppression'],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C1442824', 'cui_str': 'POU2F1 protein, human'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C4704685', 'cui_str': 'Care Retention'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",1717.0,0.242917,"1 year after ART initiation, 1472 (90·5%, 87·4-92·8) of 1627 individuals who linked in the standard ART period were in care and had a viral load of less than 400 copies per mL, compared with 578 (91·6%, 88·1-94·1) of 631 in the rapid ART period (risk ratio 1·01, 95% CI 0·92-1·11).
","[{'ForeName': 'Refeletswe', 'Initials': 'R', 'LastName': 'Lebelonyane', 'Affiliation': 'Botswana Ministry of Health and Wellness, Gaborone, Botswana.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Bachanas', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Global HIV/AIDS and TB, Atlanta, GA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Block', 'Affiliation': 'Northrop Grumman, Atlanta, GA, USA.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Ussery', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Global HIV/AIDS and TB, Atlanta, GA, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Abrams', 'Affiliation': 'Centers for Disease Control and Prevention, Gaborone, Botswana.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Roland', 'Affiliation': 'Centers for Disease Control and Prevention, Gaborone, Botswana.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Theu', 'Affiliation': 'Botswana Ministry of Health and Wellness, Gaborone, Botswana.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Kapanda', 'Affiliation': 'Botswana Ministry of Health and Wellness, Gaborone, Botswana.'}, {'ForeName': 'Stembile', 'Initials': 'S', 'LastName': 'Matambo', 'Affiliation': 'Botswana Ministry of Health and Wellness, Gaborone, Botswana.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Lockman', 'Affiliation': ""Harvard T H Chan School of Public Health, Boston, MA, USA; Brigham and Women's Hospital, Boston, MA, USA; Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.""}, {'ForeName': 'Tendani', 'Initials': 'T', 'LastName': 'Gaolathe', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; University of Botswana School of Medicine, Gaborone, Botswana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Makhema', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Global HIV/AIDS and TB, Atlanta, GA, USA.'}, {'ForeName': 'Joseph N', 'Initials': 'JN', 'LastName': 'Jarvis', 'Affiliation': 'Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana; Botswana-University of Pennsylvania Partnership, Gaborone, Botswana; Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK. Electronic address: joseph.jarvis@lshtm.ac.uk.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30187-9']
1811,32747329,Effect of an E-Learning Module on Personal Protective Equipment Proficiency Among Prehospital Personnel: Web-Based Randomized Controlled Trial.,"BACKGROUND


To avoid misuse of personal protective equipment (PPE), ensure health care workers' safety, and avoid shortages, effective communication of up-to-date infection control guidelines is essential. As prehospital teams are particularly at risk of contamination given their challenging work environment, a specific gamified electronic learning (e-learning) module targeting this audience might provide significant advantages as it requires neither the presence of learners nor the repetitive use of equipment for demonstration.
OBJECTIVE


The aim of this study was to evaluate whether a gamified e-learning module could improve the rate of adequate PPE choice by prehospital personnel in the context of the coronavirus disease (COVID-19) pandemic.
METHODS


This was an individual-level randomized, controlled, quadruple-blind (investigators, participants, outcome assessors, and data analysts) closed web-based trial. All emergency prehospital personnel working in Geneva, Switzerland, were eligible for inclusion, and were invited to participate by email in April 2020. Participants were informed that the study aim was to assess their knowledge regarding PPE, and that they would be presented with both the guidelines and the e-learning module, though they were unaware that there were two different study paths. All participants first answered a preintervention quiz designed to establish their profile and baseline knowledge. The control group then accessed the guidelines before answering a second set of questions, and were then granted access to the e-learning module. The e-learning group was shown the e-learning module right after the guidelines and before answering the second set of questions.
RESULTS


Of the 291 randomized participants, 176 (60.5%) completed the trial. There was no significant difference in baseline knowledge between groups. Though the baseline proportion of adequate PPE choice was high (75%, IQR 50%-75%), participants' description of the donning sequence was in most cases incorrect. After either intervention, adequate choice of PPE increased significantly in both groups (P<.001). Though the median of the difference in the proportion of correct answers was slightly higher in the e-learning group (17%, IQR 8%-33% versus 8%, IQR 8%-33%), the difference was not statistically significant (P=.27). Confidence in the ability to use PPE was maintained in the e-learning group (P=.27) but significantly decreased in the control group (P=.04).
CONCLUSIONS


Among prehospital personnel with an already relatively high knowledge of and experience with PPE use, both web-based study paths increased the rate of adequate choice of PPE. There was no major added value of the gamified e-learning module apart from preserving participants' confidence in their ability to correctly use PPE.",2020,"There was no major added value of the gamified e-learning module apart from preserving participants' confidence in their ability of correctly using PPE.
","['Out of the 291 randomized participants, 176 (60.5%) completed the trial', 'Personal Protective Equipment Proficiency by Prehospital Personnel', 'All emergency prehospital personnel working in Geneva, Switzerland, were eligible for inclusion, and were invited to participate by e-mail, in April 2020']","['gamified e-learning module', 'E-Learning Module', 'personal protective equipment (PPE']","['baseline knowledge', 'adequate PPE choice', 'proportion of correct answers', 'adequate choice of PPE']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",291.0,0.0691654,"There was no major added value of the gamified e-learning module apart from preserving participants' confidence in their ability of correctly using PPE.
","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Suppan', 'Affiliation': 'Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abbas', 'Affiliation': 'Infection Control Program and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Loric', 'Initials': 'L', 'LastName': 'Stuby', 'Affiliation': 'Genève TEAM Ambulances, Geneva, Switzerland.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cottet', 'Affiliation': 'Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Larribau', 'Affiliation': 'Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Golay', 'Affiliation': 'Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Iten', 'Affiliation': 'Infection Control Program and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Harbarth', 'Affiliation': 'Infection Control Program and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Gartner', 'Affiliation': 'Division of Emergency Medicine, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Suppan', 'Affiliation': 'Division of Anesthesiology, Department of Anesthesiology, Clinical Pharmacology, Intensive Care and Emergency Medicine, University of Geneva Hospitals and Faculty of Medicine, Geneva, Switzerland.'}]",Journal of medical Internet research,['10.2196/21265']
1812,32747351,"Protocol for economic evaluation alongside the SHINE (Supporting Healthy Image, Nutrition and Exercise) cluster randomised controlled trial.","INTRODUCTION


Limited evidence exists on the cost-effectiveness of interventions to prevent obesity and promote healthy body image in adolescents. The SHINE (Supporting Healthy Image, Nutrition and Exercise) study is a cluster randomised control trial (cRCT) aiming to deliver universal education about healthy nutrition and physical activity to adolescents, as well as targeted advice to young people with body image concerns who are at risk of developing disordered eating behaviours. This paper describes the methods for the economic evaluation of the SHINE cRCT, to determine whether the intervention is cost-effective as an obesity prevention measure.
METHODS AND ANALYSIS


A public payer perspective will be adopted, with intervention costs collected prospectively. Within-trial cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) will quantify the incremental costs and health gains of the intervention as compared with usual practice (ie, teacher-delivered curriculum). CEA will present results as cost per body mass index unit saved. CUA will present results as cost per quality-adjusted life year gained. A modelled CUA will extend the target population, time horizon and decision context to provide valuable information to policymakers on the potential for incremental cost offsets attributable to disease prevention arising from intervention. Intervention costs and effects will be extrapolated to the population of Australian adolescents in Grade 7 of secondary school (approximate age 13 years) and modelled over the cohort's lifetime. Modelled CUA results will be presented as health-adjusted life years saved and healthcare cost-savings of diseases averted. Incremental cost-effectiveness ratios will be calculated as the difference in costs between the intervention and comparator divided by the difference in benefit. Semi-structured interviews with key intervention stakeholders will explore the potential impact of scalability on cost-effectiveness. These data will be thematically analysed to inform sensitivity analysis of the base case economic evaluation, such that cost-effectiveness evidence is reflective of the potential for scalability.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Deakin University Human Research Ethics Committee (#2017-269) and the Victorian Department of Education and Training (#2018_003630). Study findings will be disseminated through peer-reviewed academic papers and participating schools will receive annual reports over the 3 years of data collection.
TRIAL REGISTRATION NUMBER


ACTRN 12618000330246; Pre-results.",2020,"This paper describes the methods for the economic evaluation of the SHINE cRCT, to determine whether the intervention is cost-effective as an obesity prevention measure.
","['young people with body image concerns who are at risk of developing disordered eating behaviours', ""population of Australian adolescents in Grade 7 of secondary school (approximate age 13 years) and modelled over the cohort's lifetime"", 'adolescents']","['CUA', 'CEA', 'cost-utility analysis (CUA']",['Incremental cost-effectiveness ratios'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C3853052', 'cui_str': 'Cost-Utility Analysis'}, {'cui': 'C1511536', 'cui_str': 'Cost-Effectiveness Analysis'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0974056,"This paper describes the methods for the economic evaluation of the SHINE cRCT, to determine whether the intervention is cost-effective as an obesity prevention measure.
","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Brown', 'Affiliation': 'Deakin University, Geelong, Deakin Health Economics, Institute for Health Transformation, Geelong, Victoria, Australia victoria.brown@deakin.edu.au.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Deakin University, Geelong, Institute for Health Transformation, School of Health and Social Development, Geelong, Victoria, Australia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McGivern', 'Affiliation': 'Deakin University, Geelong, Institute for Health Transformation, School of Health and Social Development, Geelong, Victoria, Australia.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Sawyer', 'Affiliation': ""Department of Paediatrics, The University of Melbourne; Centre for Adolescent Health Royal Children's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Liliana', 'Initials': 'L', 'LastName': 'Orellana', 'Affiliation': 'Deakin University, Geelong, Faculty of Health, Geelong, Victoria, Australia.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Deakin University, Geelong, School of Information Technology, Geelong, Victoria, Australia.'}, {'ForeName': 'Kylie D', 'Initials': 'KD', 'LastName': 'Hesketh', 'Affiliation': 'Deakin University, Geelong, Institute for Physical Activity and Nutrition, Faculty of Health, Geelong, Victoria, Australia.'}, {'ForeName': 'Denise E', 'Initials': 'DE', 'LastName': 'Wilfley', 'Affiliation': 'School of Medicine, Washington University in St. Louis, Missouri, Missouri, USA.'}, {'ForeName': 'Marj', 'Initials': 'M', 'LastName': 'Moodie', 'Affiliation': 'Deakin University, Geelong, Deakin Health Economics, Institute for Health Transformation, Geelong, Victoria, Australia.'}]",BMJ open,['10.1136/bmjopen-2020-038050']
1813,32748463,EBUS-TBNA versus EUS-B-FNA for the evaluation of undiagnosed mediastinal lymphadenopathy: The TEAM randomized controlled trial.,"BACKGROUND


Endobronchial Ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a standard of care modality for the evaluation of mediastinal lymphadenopathy. Transesophageal Bronchoscopic Ultrasound-Guided Fine Needle Aspiration (EUS-B-FNA), wherein one introduces the EBUS bronchoscope through the esophageal route, is also a safe and efficacious diagnostic modality for sampling the mediastinal lymph nodes. The objective of this study was to compare the diagnostic yield and patient comfort with these two available approaches.
METHODS


We randomized subjects with predominant subcarinal or lower left paratracheal mediastinal lymph node enlargement to either EBUS-TBNA or EUS-B-FNA (50 to each group). Co-Primary objectives were the comparison of adequate and diagnostic aspirates between groups. Key secondary objectives were a comparison of Operator rated cough and Operator rated procedural comfort on Visual Analog scale (VAS), procedure duration and complications between the groups.
RESULTS


Baseline characteristics were comparable between the groups. The proportion of adequate (EBUS-TBNA 46/50; 92% and EUS-B-FNA 48/50;96%, P = 0.4) and diagnostic aspirates (EBUS-TBNA 38/50; 76% and EUS-B-FNA 36/50;74%, P = 0.4) were similar between the two groups. Operator rated cough was significantly less, and Operator rated patient comfort significantly higher with the EUS-B-FNA approach. Procedure duration was significantly shorter with EUS-B-FNA [18.1(14.4) minutes versus 16.4 (49.6) minutes, P < 0.001]. Minor complications occurred in one patient in the EBUS-TBNA group and none in the EUS-B-FNA group.
CONCLUSION


During the endosonographic evaluation for undiagnosed mediastinal lymphadenopathy located at predominantly the subcarinal or lower left paratracheal stations, EUS-B-FNA as compared with EBUS-TBNA provides greater patient comfort with a similar diagnostic yield.",2020,"Operator rated cough was significantly less, and Operator rated patient comfort significantly higher with the EUS-B-FNA approach.","['We randomized subjects with predominant subcarinal or lower left paratracheal mediastinal lymph node enlargement to eitherEBUS-TBNA or EUS-B-FNA (50 toeach group', 'undiagnosed mediastinal lymphadenopathy']","['Endobronchial Ultrasound-guided transbronchial needle aspiration (EBUS-TBNA', 'EBUS-TBNA vs EUS-B-FNA', 'Transesophageal Bronchoscopic Ultrasound-Guided Fine Needle Aspiration (EUS-B-FNA']","['Operator rated cough', 'Procedure duration', 'Minorcomplications', 'comparison of Operator rated cough and Operator rated procedural comfort on Visual Analogue scale (VAS), procedure duration, and complications between the groups']","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0442143', 'cui_str': 'Paratracheal'}, {'cui': 'C0588055', 'cui_str': 'Mediastinal lymph node group'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0520743', 'cui_str': 'Mediastinal lymphadenopathy'}, {'cui': 'C0522518', 'cui_str': 'Transesophageal approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442342', 'cui_str': 'Transbronchial approach'}, {'cui': 'C0181959', 'cui_str': 'Aspiration needle'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0520743', 'cui_str': 'Mediastinal lymphadenopathy'}, {'cui': 'C0522518', 'cui_str': 'Transesophageal approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}]","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",,0.111372,"Operator rated cough was significantly less, and Operator rated patient comfort significantly higher with the EUS-B-FNA approach.","[{'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Madan', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Neha Kawatra', 'Initials': 'NK', 'LastName': 'Madan', 'Affiliation': 'Department of Pathology, VMMC and Safdarjung Hospital, New Delhi, India.'}, {'ForeName': 'Pavan', 'Initials': 'P', 'LastName': 'Tiwari', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Deepali', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Pathology, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Sudheer', 'Initials': 'S', 'LastName': 'Arava', 'Affiliation': 'Department of Pathology, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Hadda', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Anant', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Pramod', 'Initials': 'P', 'LastName': 'Garg', 'Affiliation': 'Department of Gastroenterology, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}, {'ForeName': 'Randeep', 'Initials': 'R', 'LastName': 'Guleria', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India.'}]",The clinical respiratory journal,['10.1111/crj.13244']
1814,32745830,A randomised trial comparing a brief online delivery of mindfulness-plus-values versus values only for symptoms of depression: Does baseline severity matter?,"BACKGROUND


Acceptance/mindfulness-based interventions often focus on (a) developing dispositional mindfulness and (b) pursuing personally meaningful and valued activities. Acceptance/mindfulness-based interventions can reduce depression, but little is known about the combined effects of components or the influence of baseline variables on outcomes. This study tested whether practicing a brief (10-min) mindfulness meditation over a 2-week period followed by a single values session (mindfulness+values) was more effective than values alone (values only) in reducing symptoms of depression. The study was delivered online and modules were fully self-help (i.e., no therapist contact).
METHODS


206 participants (M age =23.4 years, SD=6.53) with elevated depression scores (DASS-depression ≥ 10) were randomised to: mindfulness+values condition or a 2-week wait period followed by the values session (i.e., values only condition). Symptoms of depression were assessed at baseline, after the 2-week mindfulness practice/wait period, and 1-week following the values session.
RESULTS


Reductions in depression and recovery rates were significantly greater following mindfulness+values than values only. Baseline severity affected outcomes: mindfulness+values was significantly more beneficial than values only for individuals with high baseline levels of depression. Outcomes did not differ for those with low levels of depression. Rates of deterioration were higher than expected for values only participants.
LIMITATIONS


Conclusions are preliminary and tentative due to no follow-up period and a small sample. Drop-out was high (50%) and findings cannot be assumed to generalise to treatment seeking or more diverse samples.
CONCLUSIONS


Tentatively, results suggest mindfulness+values can significantly reduce depression, especially for individuals with higher baseline depression.",2020,Baseline severity affected outcomes: mindfulness+values was significantly more beneficial than values only for individuals with high baseline levels of depression.,"['206 participants (M age =23.4 years, SD=6.53) with elevated depression scores (DASS-depression ≥ 10']","['mindfulness-plus-values', 'practicing a brief (10-min) mindfulness meditation']","['Symptoms of depression', 'Rates of deterioration', 'depression and recovery rates']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",206.0,0.0678318,Baseline severity affected outcomes: mindfulness+values was significantly more beneficial than values only for individuals with high baseline levels of depression.,"[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kingston', 'Affiliation': 'Royal Holloway University of London Egham Hill Egham, Bowyer Building, Surrey TW20 0EX, United Kingdom. Electronic address: Jessica.kingston@rhul.ac.uk.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Becker', 'Affiliation': 'Royal Holloway University of London Egham Hill Egham, Bowyer Building, Surrey TW20 0EX, United Kingdom.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Woeginger', 'Affiliation': 'Royal Holloway University of London Egham Hill Egham, Bowyer Building, Surrey TW20 0EX, United Kingdom.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ellett', 'Affiliation': 'Royal Holloway University of London Egham Hill Egham, Bowyer Building, Surrey TW20 0EX, United Kingdom.'}]",Journal of affective disorders,['10.1016/j.jad.2020.07.087']
1815,32745945,"Chasing the desire: An investigation on the role of craving, time perspective, and alcohol use in adolescent gambling.","Chasing, or continuing to gamble to recoup losses, is a behavioral marker and a diagnostic criterion for gambling disorder. Research on chasing has focused mainly on adults, whereas the analysis of chasing behavior among adolescents has not received empirical attention in the gambling literature. The aim of the present study was to first investigate the interplay between chasing behavior, craving, temporal perspective, alcohol use, and gambling severity among Italian adolescents. Three hundred and sixty-four adolescents took part in the study. Participants completed the South Oaks Gambling Screen Revised for Adolescents (SOGS-RA), the Gambling Craving Scale (GACS), the 14-item Consideration of Future Consequences scale (CFC-14), the Alcohol Use Disorders Identification Test (AUDIT), and performed a computerized task assessing chasing behavior. Participants were randomly assigned to the control and the loss condition of the computerized task. Results indicated that the choice to continue playing, as well as chasing frequency did not vary as a function of experimental condition. Hierarchical logistic and linear regression analyses revealed that the decision to chase depended mostly on craving, whereas chasing propensity was affected by craving and alcohol misuse. Notably, gambling severity did not predict either the decision to chase, or the chasing persistence. The present study contributes important findings to the gambling literature, highlighting the role of craving alcohol use in facilitating the inability to stop within-sessions gambling among adolescents. These findings may provide evidence that nonchasers and chasers represent two different types of gamblers, and that the difference may be useful for targeting more effective therapies.",2020,"Participants completed the South Oaks Gambling Screen Revised for Adolescents (SOGS-RA), the Gambling Craving Scale (GACS), the 14-item Consideration of Future Consequences scale (CFC-14), the Alcohol Use Disorders Identification Test (AUDIT), and performed a computerized task assessing chasing behavior.","['Chasing the desire', 'Three hundred and sixty-four adolescents took part in the study', 'Italian adolescents', 'adolescent gambling']",[],"['South Oaks Gambling Screen Revised for Adolescents (SOGS-RA), the Gambling Craving Scale (GACS']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}]",[],"[{'cui': 'C0330302', 'cui_str': 'Genus Quercus'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",364.0,0.0202985,"Participants completed the South Oaks Gambling Screen Revised for Adolescents (SOGS-RA), the Gambling Craving Scale (GACS), the 14-item Consideration of Future Consequences scale (CFC-14), the Alcohol Use Disorders Identification Test (AUDIT), and performed a computerized task assessing chasing behavior.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Cosenza', 'Affiliation': 'Department of Psychology, Università degli studi della Campania ""Luigi Vanvitelli"", Viale Ellittico, 31, 81100 Caserta, Italy. Electronic address: marina.cosenza@unicampania.it.'}, {'ForeName': 'Olimpia', 'Initials': 'O', 'LastName': 'Matarazzo', 'Affiliation': 'Department of Psychology, Università degli studi della Campania ""Luigi Vanvitelli"", Viale Ellittico, 31, 81100 Caserta, Italy. Electronic address: olimpia.matarazzo@unicampania.it.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ciccarelli', 'Affiliation': 'Department of Psychology, Università degli studi della Campania ""Luigi Vanvitelli"", Viale Ellittico, 31, 81100 Caserta, Italy. Electronic address: maria.ciccarelli@unicampania.it.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Nigro', 'Affiliation': 'Department of Psychology, Università degli studi della Campania ""Luigi Vanvitelli"", Viale Ellittico, 31, 81100 Caserta, Italy. Electronic address: giovanna.nigro@unicampania.it.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106566']
1816,32745964,"Impact of sex and age on chemotherapy efficacy, toxicity and survival in localised oesophagogastric cancer: A pooled analysis of 3265 individual patient data from four large randomised trials (OE02, OE05, MAGIC and ST03).","BACKGROUND


There is a lack of large-scale randomised data evaluating the impact of sex and age in patients undergoing chemotherapy followed by potentially curative surgery for oesophagogastric cancer.
PATIENTS AND METHODS


Individual patient data from four prospective randomised controlled trials were pooled using a two-stage meta-analysis. For survival analysis, hazard ratios (HRs) were calculated for patients aged <70 and ≥ 70 years, as well as between males and females. Mandard tumour regression grade (TRG) and, ≥grade III toxicities were compared using logistic regression models to calculate odds ratios. All analyses were adjusted for the type of chemotherapy received.
RESULTS


3265 patients were included for survival analysis (2668 [82%] male, 597 [18%] female; 2627 (80%) <70 years, 638 (20%) ≥70 years). A significant improvement in overall survival (OS) (HR: 0.78; p < 0.001) and disease-specific survival (DSS) (HR: 0.78; p < 0.001) was observed in females compared with males. No significant differences in OS (HR: 1.11; p = 0.045) or DSS (HR: 1.01; p = 0.821) were observed in older patients compared with younger patients. For patients who underwent resection, older patients (15% vs 10%; p = 0.03) and female patients (14% vs 10%, p = 0.10) were more likely to achieve favourable Mandard TRG scores. Females experienced significantly more ≥grade III nausea (10% vs 5%; p≤0.001), vomiting (10% vs 4%; p≤0.001) and diarrhoea (9% vs 4%; p≤0.001) than males.
CONCLUSIONS


In this large pooled analysis using prospective randomised trial data, females had significantly improved survival while experiencing more gastrointestinal toxicities. Older patients achieved comparable survival to younger patients and thus, dependent on fitness, should be offered the same treatment paradigm.",2020,A significant improvement in overall survival (OS) (HR: 0.78; p < 0.001) and disease-specific survival (DSS) (HR: 0.78; p < 0.001) was observed in females compared with males.,"['Older patients', '3265 individual patient data from four large randomised trials (OE02, OE05, MAGIC and ST03', 'localised oesophagogastric cancer', 'patients undergoing chemotherapy followed by potentially curative surgery for oesophagogastric cancer', '3265 patients were included for survival analysis (2668 [82%] male, 597 [18%] female; 2627 (80%) <70 years, 638 (20%) ≥70 years']",[],"['chemotherapy efficacy, toxicity and survival', '≥grade III nausea', 'Mandard tumour regression grade (TRG) and, ≥grade III toxicities', 'favourable Mandard TRG scores', 'diarrhoea', 'survival', 'gastrointestinal toxicities', 'vomiting', 'disease-specific survival (DSS', 'overall survival (OS', 'For survival analysis, hazard ratios (HRs']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0024460', 'cui_str': 'Magic'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",3265.0,0.254262,A significant improvement in overall survival (OS) (HR: 0.78; p < 0.001) and disease-specific survival (DSS) (HR: 0.78; p < 0.001) was observed in females compared with males.,"[{'ForeName': 'Avani', 'Initials': 'A', 'LastName': 'Athauda', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Nankivell', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, Second Floor, London, WC1V 6LJ, United Kingdom.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Langley', 'Affiliation': 'Medical Research Council Clinical Trials Unit at University College London, 90 High Holborn, Second Floor, London, WC1V 6LJ, United Kingdom.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Alderson', 'Affiliation': 'Department of Surgery, Queen Elizabeth Hospital, Mindelsohn Way, Edgbaston, Birmingham, B15 2WB, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Allum', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, United Kingdom.'}, {'ForeName': 'Heike I', 'Initials': 'HI', 'LastName': 'Grabsch', 'Affiliation': ""Department of Pathology, GROW School for Oncology and Developmental Biology, Maastricht University Medical Center+, P. Debyelaan 25, 6229 HX Maastricht, The Netherlands; Pathology and Data Analytics, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, LS9 7TF, United Kingdom.""}, {'ForeName': 'Naureen', 'Initials': 'N', 'LastName': 'Starling', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Gastrointestinal and Lymphoma Unit, The Royal Marsden NHS Foundation Trust, Downs Road, Sutton, Surrey, SM2 5PT, United Kingdom. Electronic address: david.cunningham@rmh.nhs.uk.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.06.005']
1817,32750431,Protocol for Partner2Lose: A randomized controlled trial to evaluate partner involvement on long-term weight loss.,"BACKGROUND


Behavioral interventions produce clinically significant weight reduction, with many participants regaining weight subsequently. Most interventions focus on an individual, but dietary and physical activity behaviors occur with, or are influenced by, domestic partners. According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change. We utilized interdependence theory to develop a partner-assisted intervention to increase long-term weight loss.
METHODS


Community-dwelling individuals (index participants) cohabitating with a partner with 1) overweight and at least one obesity-related comorbidity or 2) obesity are randomized to participate in a standard weight management program alone or with their partner. The weight management program involves biweekly, in-person, group sessions focusing on weight loss for six months, followed by three group sessions and nine telephone calls focusing on weight loss maintenance for twelve months. In the partner-assisted arm, partners participate in half of the group sessions and telephone calls. Couples receive training in principles of cognitive behavioral therapy for couples, including sharing thoughts and feelings and joint problem solving, to increase communal coping. The primary outcome is participant weight loss at 24 months, with caloric intake and moderate-intensity physical activity as secondary outcomes. Partner weight and caloric intake will also be analyzed. Mediation analyses will examine the role of interdependence variables and social support.
DISCUSSION


This trial will provide knowledge about effective ways to promote long-term weight loss and the role of interdependence constructs in weight loss. Clinical trials identifier: NCT03801174.",2020,"According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change.",['Community-dwelling individuals (index participants) cohabitating with a partner with 1) overweight and at least one obesity-related comorbidity or 2) obesity'],"['training in principles of cognitive behavioral therapy', 'standard weight management program alone or with their partner']","['Partner weight and caloric intake', 'participant weight loss at 24\u202fmonths, with caloric intake and moderate-intensity physical activity']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0164121,"According to interdependence theory, couples who approach behavior change as a problem to be tackled together versus independently are more likely to utilize communal coping processes to promote behavior change.","[{'ForeName': 'Corrine I', 'Initials': 'CI', 'LastName': 'Voils', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA; William S Middleton Memorial Veterans Hospital, 2500 Overlook Terrace (151), Madison, WI 53705, USA. Electronic address: voils@surgery.wisc.edu.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Shaw', 'Affiliation': 'Duke University School of Nursing, 307 Trent Dr., 1055 Clipp, Durham, NC 27710, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Adler', 'Affiliation': ""Center for Surgery and Public Health, Brigham and Women's Hospital, One Brigham Circle, 1620 Tremont Street Suite 2-016, Boston, MA 02120, USA.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jeanes', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': 'RTI International, 119 S. Main St., Union Trust Bldg., Suite 220, Seattle, WA 98104, USA.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Sharp', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'Kate A', 'Initials': 'KA', 'LastName': 'Cronin', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hetzel', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Biostatistics and Bioinformatics, 610 Walnut St, WARF 201, Madison, WI 53726, USA.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Biostatistics and Bioinformatics, 610 Walnut St, WARF 201, Madison, WI 53726, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Johnson', 'Affiliation': ""Boca Raton Regional Hospital, Christine E. Lynn Women's Health & Wellness Institute, 690 Meadows Road, Boca Raton, FL 33486, USA.""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Elwert', 'Affiliation': 'University of Wisconsin-Madison Department of Sociology, 11800 Observatory Dr, Madison, WI 53706, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Pabich', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Medicine, 1685 Highland Ave Madison, WI 53705-2281, USA.'}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Gavin', 'Affiliation': 'University of Wisconsin-Madison School of Medicine & Public Health, Department of Surgery, 600 Highland Ave, K6/100 CSC, Madison, WI 53792-1690, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Yancy', 'Affiliation': 'Duke University School of Medicine, Department of Medicine, 501 Douglas St., Durham, NC 27705, USA.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, Box 90399, Durham, NC 27708, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106092']
1818,32750502,"Impact of age on efficacy and early mortality of initial sequential treatment versus upfront combination chemotherapy in patients with metastatic colorectal cancer: a subgroup analysis of a phase III trial (AIO KRK0110, XELAVIRI study).","INTRODUCTION


The XELAVIRI study compared application of fluoropyrimidine (FP) and bevacizumab (Bev) followed by sequential escalation to irinotecan (Iri), FP and Bev (arm A) to upfront combination therapy with FP, Iri and Bev (arm B) in patients with metastatic colorectal cancer (mCRC). To elucidate the impact of age on survival, we evaluated efficacy and early mortality in the underlying trial.
METHODS


Patients were stratified for age in three cohorts (<65 years, 65-74 years and ≥75 years). Survival end-points were expressed by the Kaplan-Meier method and compared by log-rank testing and Cox regression. Objective response and 60-day mortality were evaluated by chi-square testing.
RESULTS


The efficacy analyses suggest more substantial benefit from upfront combination chemotherapy in younger patients with mCRC. Elderly patients (≥75 years) derived limited benefit from upfront combination chemotherapy, particularly in terms of overall survival. Of 421 randomised patients, 13 patients (3.1%) died within 60 days after treatment initiation with the highest prevalence in elderly patients (1.6% < 65 years, 2.8% 65-74 years and 5.2% ≥ 75 years, p = 0.26). The frequency of 60-day mortality was significantly associated with age (with a maximum of 8.7% in patients aged ≥75 years) in patients undergoing upfront combination therapy (p = 0.027) but not in patients receiving sequential treatment (p = 0.63).
CONCLUSION


Combination therapy with FP, Iri and Bev does not substantially improve the outcome of patients aged ≥75 years as compared with sequential treatment algorithm. These patients appear to be at a relevant risk for 60-day mortality under Iri-based combination chemotherapy plus Bev.",2020,"CONCLUSION


Combination therapy with FP, Iri and Bev does not substantially improve the outcome of patients aged ≥75 years as compared with sequential treatment algorithm.","['patients with metastatic colorectal cancer', 'Elderly patients (≥75 years', 'younger patients with mCRC', 'patients aged ≥75 years', 'Patients were stratified for age in three cohorts (<65 years, 65-74 years and ≥75 years', 'patients with metastatic colorectal cancer (mCRC']","['upfront combination chemotherapy', 'fluoropyrimidine (FP) and bevacizumab (Bev) followed by sequential escalation to irinotecan (Iri), FP and Bev (arm A) to upfront combination therapy with FP, Iri and Bev (arm B']","['Objective response and 60-day mortality', 'frequency of 60-day mortality', 'efficacy and early mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0022077', 'cui_str': 'Iris structure'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",421.0,0.107606,"CONCLUSION


Combination therapy with FP, Iri and Bev does not substantially improve the outcome of patients aged ≥75 years as compared with sequential treatment algorithm.","[{'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Kurreck', 'Affiliation': 'Charité University Medicine, Department of Hematology, Oncology, and Tumor Immunology (CVK), Berlin, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Heinemann', 'Affiliation': 'University Hospital Grosshadern, Ludwig Maximilians Universität (LMU), Department of Medical Oncology & Comprehensive Cancer Center, Munich, Germany; German Cancer Consortium (DKTK), DKFZ, Heidelberg, Germany.'}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Fischer von Weikersthal', 'Affiliation': 'Gesundheitszentrum St. Marien, Amberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Decker', 'Affiliation': 'Oncological Practice, Ravensburg, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'Oncological Practice, Landshut, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Uhlig', 'Affiliation': 'Oncological Practice, Naunhof, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schenk', 'Affiliation': ""Clinic 'Barmherzige Brüder Regensburg', Regensburg, Germany.""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Freiberg-Richter', 'Affiliation': 'Oncological Practice, Dresden, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Peuser', 'Affiliation': 'Oncological Practice am Diakonissenhaus, Leipzig, Germany.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Denzlinger', 'Affiliation': 'Marienhospital, Stuttgart, Germany.'}, {'ForeName': 'Ullrich', 'Initials': 'U', 'LastName': 'Graeven', 'Affiliation': 'Kliniken Maria Hilf GmbH, Mönchengladbach, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Schwaner', 'Affiliation': 'Oncological Practice Kurfürstendamm, Berlin, Germany.'}, {'ForeName': 'Arndt', 'Initials': 'A', 'LastName': 'Stahler', 'Affiliation': 'University Hospital Grosshadern, Ludwig Maximilians Universität (LMU), Department of Medical Oncology & Comprehensive Cancer Center, Munich, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Heinrich', 'Affiliation': 'University Hospital Grosshadern, Ludwig Maximilians Universität (LMU), Department of Medical Oncology & Comprehensive Cancer Center, Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jung', 'Affiliation': 'German Cancer Consortium (DKTK), DKFZ, Heidelberg, Germany; Ludwig Maximilians-University, Department of Pathology, Munich, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Held', 'Affiliation': 'ClinAssess GmbH, Leverkusen, Germany.'}, {'ForeName': 'Jobst C', 'Initials': 'JC', 'LastName': 'von Einem', 'Affiliation': 'Charité University Medicine Berlin, Department of Hematology, Oncology, and Tumor Immunology (CCM), Berlin, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Stintzing', 'Affiliation': 'Charité University Medicine Berlin, Department of Hematology, Oncology, and Tumor Immunology (CCM), Berlin, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Giessen-Jung', 'Affiliation': 'University Hospital Grosshadern, Ludwig Maximilians Universität (LMU), Department of Medical Oncology & Comprehensive Cancer Center, Munich, Germany.'}, {'ForeName': 'Dominik P', 'Initials': 'DP', 'LastName': 'Modest', 'Affiliation': 'Charité University Medicine, Department of Hematology, Oncology, and Tumor Immunology (CVK), Berlin, Germany. Electronic address: dominik.modest@charite.de.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.06.010']
1819,32750571,Recurrent venous thromboembolism during anticoagulation with edoxaban or warfarin: A post hoc analysis of the Hokusai-VTE trial.,"INTRODUCTION


Venous thromboembolism (VTE) may recur during anticoagulation, but the actual rate is not well established. In a post hoc analysis of the Hokusai-VTE trial we evaluated the risk and determinants of recurrent VTE of patients during anticoagulation with heparin, edoxaban or warfarin.
MATERIALS AND METHODS


The Hokusai-VTE study showed that in VTE patients edoxaban was non-inferior to warfarin with significantly less bleeding. Treatment duration ranged from 3 to 12 months. The recurrent VTE during anticoagulation period was defined as the VTE which occurred from the date of the first to the last dose (+3 days) of study drug.
RESULTS


147 of 8240 patients (1.8%) had a recurrent VTE during anticoagulant treatment. Median duration of anticoagulation was 267 days. 80 (54%) patients recurred within the first 30 days, 39 of those during heparin lead-in. 23 of 147 patients died of pulmonary embolism (PE) during anticoagulation (case fatality rate 15.6%). 13 of those fatalities (57%) occurred during the first 30 days; 4 of those during heparin lead-in. The recurrence risk was numerically lower in patients assigned to edoxaban compared to those assigned to warfarin, particularly beyond 30 days. We observed a trend towards a higher proportion of men, high NT-proBNP levels and obesity at the time of diagnosis among patients with early recurrence and mortality in particular.
CONCLUSION


The risk of recurrent VTE and PE-related mortality during the time of anticoagulation is low but noteworthy. Further studies are warranted to sharpen the risk profile of VTE patients in order to improve treatment and reduce mortality.",2020,23 of 147 patients died of pulmonary embolism (PE) during anticoagulation (case fatality rate 15.6%).,"['23 of 147 patients died of pulmonary embolism (PE) during anticoagulation (case fatality rate 15.6', '147 of 8240 patients (1.8%) had a recurrent VTE during anticoagulant treatment']","['edoxaban', 'warfarin', 'heparin, edoxaban or warfarin', 'VTE patients edoxaban', 'edoxaban or warfarin']","['Median duration of anticoagulation', 'recurrence risk', 'Recurrent venous thromboembolism', 'bleeding']","[{'cui': 'C1306577', 'cui_str': 'O/E - dead'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0282250', 'cui_str': 'Case fatality rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",8240.0,0.0356656,23 of 147 patients died of pulmonary embolism (PE) during anticoagulation (case fatality rate 15.6%).,"[{'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Eichinger', 'Affiliation': 'Dept. of Medicine I, Medical University of Vienna, Austria. Electronic address: sabine.eichinger@meduniwien.ac.at.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Basking Ridge, NJ, United States of America.'}, {'ForeName': 'Minggao', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Basking Ridge, NJ, United States of America.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Grosso', 'Affiliation': 'Daiichi-Sankyo Pharma Development, Basking Ridge, NJ, United States of America.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Kyrle', 'Affiliation': 'Dept. of Medicine I, Medical University of Vienna, Austria.'}]",Thrombosis research,['10.1016/j.thromres.2020.07.028']
1820,32756091,A randomized controlled clinical trial study protocol of Liuwei Dihuang pills in the adjuvant treatment of diabetic kidney disease.,"INTRODUCTION


A large number of patients with diabetic kidney disease (DKD) approach traditional Chinese medicine (TCM) owing to discontent with standard treatments. Based on TCM theory and clinical experience, the syndrome of kidney yin deficiency is a common type of DKD. Liuwei Dihuang pills (LDPs) is a common prescription of a Chinese herbal formula for patients presenting this syndrome of DKD. However, well-established data supporting the efficacy and safety of LDP in DKD treatment are lacking.
METHODS


We have designed a double-blind, placebo-controlled, randomized trial. After a 2-week run-in period, 124 eligible participants with DKD will be assigned to either the experimental or the control group in a 1:1 ratio. Patients in the experimental group will receive LDP, while patients in the control group will receive a matched placebo. As the basic treatment in the 2 groups, metformin hydrochloride sustained-release tablets, for blood glucose control, and irbesartan tablets, for blood pressure regulation, will be provided. All participants will undergo 4 weeks of treatment and 12 weeks of follow-up. The primary outcome is the change in 24 hours urinary protein levels, measured from the baseline to the end of the treatment phase (week 24). The secondary outcomes to be assessed include the change in serum creatinine and estimated glomerular filtration rate, urinary albumin excretion rate, improvement of TCM syndromes and symptoms, fasting blood glucose and postprandial 2-hour blood glucose, blood lipids (total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol, from baseline to weeks 12 and 24.
DISCUSSION


The results of this study will provide high-quality evidence of the effects of LDP in DKD treatment, which will provide an alternative treatment strategy in patients with DKD.",2020,"The primary outcome is the change in 24 hours urinary protein levels, measured from the baseline to the end of the treatment phase (week 24).","['patients presenting this syndrome of DKD', 'patients with diabetic kidney disease (DKD) approach traditional Chinese medicine (TCM', '124 eligible participants with DKD', 'diabetic kidney disease', 'patients with DKD']","['Liuwei Dihuang pills', 'Liuwei Dihuang pills (LDPs', 'metformin hydrochloride', 'LDP', 'placebo']","['change in 24\u200ahours urinary protein levels', 'blood glucose control, and irbesartan tablets, for blood pressure regulation', 'change in serum creatinine and estimated glomerular filtration rate, urinary albumin excretion rate, improvement of TCM syndromes and symptoms, fasting blood glucose and postprandial 2-hour blood glucose, blood lipids (total cholesterol, triglyceride, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C4517553', 'cui_str': '124'}]","[{'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0770893', 'cui_str': 'Metformin hydrochloride'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0428479', 'cui_str': 'Protein level - finding'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1244726', 'cui_str': 'irbesartan Oral Tablet'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0585937', 'cui_str': 'Albumin excretion rate measurement'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}]",124.0,0.149074,"The primary outcome is the change in 24 hours urinary protein levels, measured from the baseline to the end of the treatment phase (week 24).","[{'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Liao', 'Affiliation': 'Department of Endocrinology.'}, {'ForeName': 'Keni', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Ophthalmology, Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, China.'}, {'ForeName': 'Shiyun', 'Initials': 'S', 'LastName': 'Tang', 'Affiliation': 'Department of Endocrinology.'}, {'ForeName': 'Keling', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Chunguang', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Department of Endocrinology.'}, {'ForeName': 'Chuantao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory Medicine.'}, {'ForeName': 'Wenfan', 'Initials': 'W', 'LastName': 'Gan', 'Affiliation': 'Department of Respiratory Medicine.'}]",Medicine,['10.1097/MD.0000000000021137']
1821,32756180,Th17/Treg imbalance in patients with severe acute pancreatitis: Attenuated by high-volume hemofiltration treatment.,"BACKGROUND


To investigate the effect of high-volume hemofiltration (HVHF) on Th17/Treg imbalance in patients with severe acute pancreatitis (SAP).
METHODS


Forty-two patients with SAP were randomly received 24 hours of continuous HVHF (n = 21) or without HVHF (n = 21). At day 28, all 42 patients were divided into survival group (n = 32) and non-survival group (n = 10). Venous blood samples collected at 0, 6, 12, and 24 hours during HVHF treatment (or equivalent time in non-HVHF group) were assessed by flow cytometry to detect Th17 and Treg cells. Concentrations of IL-6, IL-17, IL-10, and TGF-β1 were detected by enzyme-linked immunosorbent assay.
RESULTS


Th17%, Treg%, Th17/Treg, and levels of related cytokines were significantly higher in SAP patients than healthy controls (P < .05), and these changes were more pronounced in SAP patients with multiple organ failure than those with single organ failure (P < .05). After HVHF treatment, Th17%, Treg%, Th17/Treg, IL-6, IL-17, and IL-10 significantly reduced (P < .05), while there were no significant changes in non-HVHF group (P > .05). In addition, acute physiology and chronic health evaluation II and sequential organ failure assessment scores decreased markedly after HVHF treatment. Baselines of Th17%, Treg%, Th17/Treg, and related cytokines were significantly higher in non-survival group than survival group. Both acute physiology and chronic health evaluation I score and IL-6 level were positively correlated with Th17% before and after HVHF treatment (P < .01).
CONCLUSIONS


Th17/Treg imbalance is present in SAP and may be correlated with its severity and prognosis. HVHF effectively attenuates the Th17/Treg imbalance in SAP patients. The beneficial effect of HVHF on Th17/Treg imbalance is possibly associated with removing excess inflammatory mediators.",2020,"After HVHF treatment, Th17%, Treg%, Th17/Treg, IL-6, IL-17, and IL-10 significantly reduced (P < .05), while there were no significant changes in non-HVHF group (P > .05).","['Forty-two patients with SAP', 'patients with severe acute pancreatitis', 'SAP patients', 'patients with severe acute pancreatitis (SAP']","['high-volume hemofiltration (HVHF', 'HVHF', 'continuous HVHF (n\u200a=\u200a21) or without HVHF']","['Treg%, Th17/Treg, and levels of related cytokines', 'acute physiology and chronic health evaluation I score and IL-6 level', 'Treg%, Th17/Treg, IL-6, IL-17, and IL-10', 'Th17/Treg imbalance', 'Concentrations of IL-6, IL-17, IL-10, and TGF-β1', 'acute physiology and chronic health evaluation II and sequential organ failure assessment scores', 'Treg%, Th17/Treg, and related cytokines']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001339', 'cui_str': 'Acute pancreatitis'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0019014', 'cui_str': 'Hemofiltration'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0243030', 'cui_str': 'Acute physiology and chronic health evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0243028', 'cui_str': 'Acute physiology and chronic health evaluation II'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}]",42.0,0.0236775,"After HVHF treatment, Th17%, Treg%, Th17/Treg, IL-6, IL-17, and IL-10 significantly reduced (P < .05), while there were no significant changes in non-HVHF group (P > .05).","[{'ForeName': 'Jiguang', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Department of Nephrology,People's Hospital of Rongchang District.""}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Yongchuan Hospital of Chongqing Medical University.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Tang', 'Affiliation': 'Department of Nephrology, Yongchuan Hospital of traditional Chinese Medicine, Chongqing, China.'}, {'ForeName': 'Jianbin', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Yongchuan Hospital of Chongqing Medical University.'}]",Medicine,['10.1097/MD.0000000000021491']
1822,32756204,A study on respiratory management in acute postoperative period by nasal high flow for patients undergoing surgery under general anesthesia.,"In head and neck surgery where the oropharyngeal area is the operative field, postoperative respiratory depression and upper airway obstruction are common. Therefore, supplemental oxygen is administered to prevent severe postoperative early hypoxemia. However, a high concentration of oxygen increases the likelihood of secondary complications, such as carbon dioxide (CO2) narcosis. Nasal high-flow (NHF) therapy generates high flows (≤60 L/min) of heated and humidified gas delivered via nasal cannula and provides respiratory support by generating positive airway pressure, clearance of dead space and reduction of work of breathing. This study aims to determine whether the postoperative hypoxemia and hypercapnia can be prevented by NHF without the requirement of supplemental oxygen. The study will recruit adult patients undergoing planned oral surgery under general anesthesia at Nagasaki University Hospital. It is a randomized parallel group comparative study with 3 groups: NHF with room air only and no supplemental oxygen, no respiratory support, and face mask oxygen administration. The study protocol will begin at the time that the patient is returned to the general ward and will finish 3 hours later. The primary endpoint is the time-weighted average of transcutaneous O2 over the 180 minutes and secondary endpoints are the time-weighted average of transcutaneous CO2 (tcpCO2), SpO2, and respiratory rate, incidence rate of marked hypercapnia (tcpCO2 ≥60 mm Hg for 5 minutes or longer), incidence rate of moderate hypercapnia (tcpCO2 ≥50 mm Hg for 5 minutes or longer) and the percentage of time that SpO2 is <90%. Included also is a group in which the postoperative management is performed only by spontaneous breathing without performing respiratory support such as oxygen administration, to investigate the efficacy and necessity of conventional oxygen administration. This exploratory study will investigate the use of NHF without supplemental oxygen as an effective respiratory support during the acute postoperative period. TRIAL REGISTRATION:: The study was registered the jRCTs072200018. URL https://jrct.niph.go.jp/latest-detail/jRCTs072200018.",2020,"Nasal high-flow (NHF) therapy generates high flows (≤60 L/min) of heated and humidified gas delivered via nasal cannula and provides respiratory support by generating positive airway pressure, clearance of dead space and reduction of work of breathing.","['patients undergoing surgery under general anesthesia', 'adult patients undergoing planned oral surgery under general anesthesia at Nagasaki University Hospital']","['Nasal high-flow (NHF) therapy', 'NHF without supplemental oxygen', 'NHF with room air only and no supplemental oxygen, no respiratory support, and face mask oxygen administration']","['carbon dioxide (CO2) narcosis', 'positive airway pressure, clearance of dead space and reduction of work of breathing', 'time-weighted average of transcutaneous O2', 'time-weighted average of transcutaneous CO2 (tcpCO2), SpO2, and respiratory rate, incidence rate of marked hypercapnia (tcpCO2 ≥60 mm Hg for 5 minutes or longer), incidence rate of moderate hypercapnia (tcpCO2 ≥50 mm Hg for 5 minutes or longer) and the percentage of time that SpO2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]","[{'cui': 'C0221340', 'cui_str': 'Carbon dioxide narcosis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0043229', 'cui_str': 'Work of Breathing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C1318131', 'cui_str': 'TcPCO2'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",,0.0988491,"Nasal high-flow (NHF) therapy generates high flows (≤60 L/min) of heated and humidified gas delivered via nasal cannula and provides respiratory support by generating positive airway pressure, clearance of dead space and reduction of work of breathing.","[{'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Kurata', 'Affiliation': 'Department of Dental Anesthesiology.'}, {'ForeName': 'Gaku', 'Initials': 'G', 'LastName': 'Mishima', 'Affiliation': 'Department of Dental Anesthesiology.'}, {'ForeName': 'Motohiro', 'Initials': 'M', 'LastName': 'Sekino', 'Affiliation': 'Division of Intensive Care.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Sato', 'Affiliation': 'Clinical Research Center, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Pinkham', 'Affiliation': 'Fisher and Paykel Healthcare Ltd, Auckland, New Zealand.'}, {'ForeName': 'Stanislav', 'Initials': 'S', 'LastName': 'Tatkov', 'Affiliation': 'Fisher and Paykel Healthcare Ltd, Auckland, New Zealand.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Ayuse', 'Affiliation': 'Department of Dental Anesthesiology.'}]",Medicine,['10.1097/MD.0000000000021537']
1823,32757479,Capsaicin combined with ice stimulation improves swallowing function in patients with dysphagia after stroke: A randomised controlled trial.,"BACKGROUND


Dysphagia is a common condition after stroke, and it is associated with many complications. Early and effective treatments are essential to the prognosis of patients with dysphagia. We aimed to evaluate the effects and safety of capsaicin combined with ice stimulation in patients with dysphagia after stroke.
METHODS


Patients with dysphagia admitted to our hospital from December 2017 to December 2019 were included. The control group received the ice stimulation, and the experimental group received the combined capsaicin and ice stimulation. The grade of water swallowing test (WST), standard swallowing assessment (SSA) scores and the serum substance P level was compared between control (ice only) and experimental group (capsaicin plus ice).
RESULTS


No differences before treatment and significance following treatment in each group (before and after) and between groups (capsaicin plus ice vs ice only) were found (all P > .05); the SSA scores were significantly reduced after intervention for both groups (all P < .001), and after intervention, SSA score in experimental group was significantly less than that of control group (P < .001). After intervention, the number of patients graded as WST level I-II in experimental group was significantly more than that of control group (P < .001); the serum substance P level was significantly increased after intervention for both groups (all P < .05), and after intervention, the serum substance P level in experimental group was significantly higher than that of control group (P = .007).
CONCLUSIONS


The combined use of capsaicin with ice stimulation is beneficial to the recovery of swallowing function of patients with dysphagia, which should be included into the clinical practice.",2020,"The grade of water swallowing test (WST), Standard Swallowing Assessment (SSA) scores and the serum substance P level were compared between control (ice only) and experimental group(capsaicin plus ice).
","['patients with dysphagia', 'patients with dysphagia after stroke', 'Patients with dysphagia admitted to our hospital from December 2017 to December 2019 were included']","['combined capsaicin and ice stimulation', 'capsaicin combined with ice stimulation', 'capsaicin with ice stimulation', 'Capsaicin combined with ice stimulation']","['serum substance P level', 'swallowing function', 'SSA score', 'grade of water swallowing test (WST), Standard Swallowing Assessment (SSA) scores and the serum substance P level', 'SSA scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0006931', 'cui_str': 'Capsaicin'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011167', 'cui_str': 'Deglutition'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.027652,"The grade of water swallowing test (WST), Standard Swallowing Assessment (SSA) scores and the serum substance P level were compared between control (ice only) and experimental group(capsaicin plus ice).
","[{'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Cui', 'Affiliation': 'ICU, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Qingmei', 'Initials': 'Q', 'LastName': 'Yin', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Meifen', 'Initials': 'M', 'LastName': 'Shen', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Yijie', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Haiying', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': 'Department of Neurosurgery, The First Affiliated Hospital of Soochow University, Suzhou, China.'}]",Journal of oral rehabilitation,['10.1111/joor.13068']
1824,32756138,A study on the effectiveness of pharmacopuncture for chronic neck pain: A protocol for a pragmatic randomized controlled trial.,"BACKGROUND


Neck pain is a common musculoskeletal disorder that impacts individuals' daily life, and might sometimes lead to disability and increased medical costs. Pharmacopuncture combines acupuncture with herbal medicine, in which herbal extracts are administered on the acupoints. We designed a pragmatic randomized controlled trial (RCT) to compare the effectiveness of pharmacopuncture and physical therapy as a treatment for chronic neck pain.
METHODS


This study is a 2-armed, parallel, multi-center RCT. The participants will be randomly assigned to pharmacopuncture or physical therapy group to receive their respective 8-session treatments for 4 weeks. The primary outcome is the visual analogue scale of neck pain. Secondary outcomes is the Northwick Park questionnaire, visual analogue scale of radiating arm pain, numeric rating scale of the neck and arm bothersomeness, neck disability index, patient global impression of change, short form-12 health survey version 2, and 5-level EuroQol-5 dimension.
DISCUSSION


This is a protocol for a pragmatic RCT that would attempt to present evidence conducive to clinical decision or policy-making by investigating the effectiveness of pharmacopuncture therapy, a widely used approach in Korean medicine clinical practice, in comparison to the standard therapy.",2020,"Secondary outcomes is the Northwick Park questionnaire, visual analogue scale of radiating arm pain, numeric rating scale of the neck and arm bothersomeness, neck disability index, patient global impression of change, short form-12 health survey version 2, and 5-level EuroQol-5 dimension.
",['chronic neck pain'],"['pharmacopuncture and physical therapy', 'Pharmacopuncture combines acupuncture with herbal medicine', 'pharmacopuncture', 'pharmacopuncture or physical therapy group to receive their respective 8-session treatments']","['Northwick Park questionnaire, visual analogue scale of radiating arm pain, numeric rating scale of the neck and arm bothersomeness, neck disability index, patient global impression of change, short form-12 health survey version 2, and 5-level EuroQol-5 dimension', 'visual analogue scale of neck pain']","[{'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}]","[{'cui': 'C4279921', 'cui_str': 'Pharmacopuncture'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0237771', 'cui_str': 'Parks, Recreational'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0332301', 'cui_str': 'Radiating to'}, {'cui': 'C0239377', 'cui_str': 'Pain in upper limb'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0456951', 'cui_str': 'Level 5'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]",,0.194569,"Secondary outcomes is the Northwick Park questionnaire, visual analogue scale of radiating arm pain, numeric rating scale of the neck and arm bothersomeness, neck disability index, patient global impression of change, short form-12 health survey version 2, and 5-level EuroQol-5 dimension.
","[{'ForeName': 'Kyoung Sun', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Jaseng Hospital of Korean Medicine.'}, {'ForeName': 'Yoon Jae', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Gangnam-gu, Seoul, Republic of Korea.'}, {'ForeName': 'Jinho', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Jaseng Hospital of Korean Medicine.'}, {'ForeName': 'In-Hyuk', 'Initials': 'IH', 'LastName': 'Ha', 'Affiliation': 'Jaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Gangnam-gu, Seoul, Republic of Korea.'}]",Medicine,['10.1097/MD.0000000000021406']
1825,32756146,Evaluation of protective equipment for the reduction of radiation exposure to physicians performing fluoroscopically guided lumbar transforaminal epidural steroid injections: A randomized controlled trial.,"BACKGROUND


Spine interventionists frequently employ fluoroscopy to guide injection procedures. The increase in fluoroscopically guided procedures in recent years has led to a growing concern about radiation exposure. A new method of covering the C-arm tube with a lead apron has been suggested to reduce radiation exposure. This study aimed to compare the radiation exposure when performing lumbar transforaminal epidural steroid injections (TFESIs) using this new method to a control group.
METHODS


A total of 200 patients who underwent lumbar TFESIs by a single physician were recruited. Patients were divided into 2 groups, the new method group (group A) and the control group (group C), and the amount of radiation exposure was compared. The dosimetry badge locations were marked as outside of apron, inside of apron, outside of thyroid collar, inside of thyroid collar, ring, and glasses.
RESULTS


The cumulative dose equivalents of all the measurement sites were reduced in group A compared with group C, and the most reduced site was inside the thyroid collar.
CONCLUSIONS


Covering the C-arm tube with a lead apron can be effective in reducing the cumulative radiation exposure when performing fluoroscopically guided TFESIs.",2020,"The cumulative dose equivalents of all the measurement sites were reduced in group A compared with group C, and the most reduced site was inside the thyroid collar.
","['200 patients who underwent lumbar TFESIs by a single physician were recruited', 'physicians performing fluoroscopically guided lumbar transforaminal epidural steroid injections']","['lumbar transforaminal epidural steroid injections (TFESIs', 'protective equipment']",['cumulative dose equivalents'],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205163', 'cui_str': 'Equal'}]",200.0,0.026103,"The cumulative dose equivalents of all the measurement sites were reduced in group A compared with group C, and the most reduced site was inside the thyroid collar.
","[{'ForeName': 'Won-Joong', 'Initials': 'WJ', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, School of Medicine, Ewha Womans University, Ewha Womans University Mokdong Hospital, Yangcheon-gu.'}, {'ForeName': 'Seung Hee', 'Initials': 'SH', 'LastName': 'Yoo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, School of Medicine, Ewha Womans University, Ewha Womans University Mokdong Hospital, Yangcheon-gu.'}, {'ForeName': 'Hahck Soo', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, School of Medicine, Ewha Womans University, Ewha Womans University Seoul Hospital, Gangseo-gu, Seoul, Republic of Korea.'}]",Medicine,['10.1097/MD.0000000000021424']
1826,32756160,The role of acupotomy in treatment of patients with lumbar spinal stenosis: A protocol for a randomized study.,"BACKGROUND


Currently, there is some clinical evidence supporting the use of acupuncture in alleviating pain and dysfunction in patients with lumbar spinal stenosis (LSS). However, the question of whether acupuncture could be efficacious for ageing patients remains unanswered. We designed a randomized controlled study to evaluate the safety and feasibility of acupuncture for participants with symptomatic LSS.
METHODS


This study is a randomized, single-blind, noninferiority trial. This clinical trial was approved by the Linyi Cancer Hospital. We received informed consent from all patients before surgery. In preparing this report, we adhered to the Consolidated Standards of Reporting Trials guidelines. We randomized consented study participants on a 1:1 ratio to one of two study groups (acupuncture and control groups) using a computer-generated list of random numbers in varying block sizes. Three outcome measures were selected to evaluate the effectiveness and safety of the treatment: visual analogue score and Oswestry disability index, and complicatins. A P < .05 was regarded as statistically significant.
RESULTS


The hypothesis was that the acupuncture group would achieve acceptable clinical outcomes as compared to the control group in LSS.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5744).",2020,"Three outcome measures were selected to evaluate the effectiveness and safety of the treatment: visual analogue score and Oswestry disability index, and complicatins.","['participants with symptomatic LSS', 'patients with lumbar spinal stenosis', 'patients with lumbar spinal stenosis (LSS']","['acupotomy', 'acupuncture']","['safety and feasibility', 'effectiveness and safety of the treatment: visual analogue score and Oswestry disability index, and complicatins']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4505457', 'cui_str': 'Acupotomy'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",,0.193331,"Three outcome measures were selected to evaluate the effectiveness and safety of the treatment: visual analogue score and Oswestry disability index, and complicatins.","[{'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation, Linyi Central Hospital.'}, {'ForeName': 'Huaihua', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': ""Department of Obstetrics and Gynecology, The third People's Hospital of Linyi.""}, {'ForeName': 'Mingyu', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Linyi Central Hospital.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Bone Oncology, Linyi Cancer Hospital, Shandong, China.'}]",Medicine,['10.1097/MD.0000000000021444']
1827,32756176,"Effects of Yangxinshi tablet on exercise tolerance in patients with coronary heart disease: A protocol of randomized, double-blind, placebo-controlled, and multi-center trial.","BACKGROUND


Exercise intolerance is very common in patients with coronary heart disease (CHD). Although some researches confirming the validation of traditional Chinese medicine (TCM) on CHD treatment, the effect of TCM on improving the exercise tolerance of patients with CHD remains unclear so far. Our trial is to investigate whether the Yangxinshi (YXS) tablet can improve exercise tolerance as well as the quality of life among CHD patients.
METHODS


It is a randomized, double-blind, placebo-controlled, multi-center trial. A total of 90 patients with CHD from 3 hospitals in China will be enrolled and randomly assigned to one of 2 groups: YXS group, N = 45; placebo group, N = 45. The 2 groups will simultaneously receive standardized western medicine and exercise-based cardiac rehabilitation program for 12 weeks. The primary outcome measure is the exercise capacity, which will be evaluated by the cardiopulmonary exercise test and 6-minute walking test. The 2nd outcomes include symptom improvement, psychologic issues, laboratory tests, side effects, and adverse events.
DISCUSSION


To our knowledge, it is the 1st randomized controlled trial to evaluate the effect of TCM YXS tablet on exercise tolerance in patients with CHD. The results will provide more evidence for future studies in this area.
TRIAL REGISTRATION


This study protocol was registered in Research Registry (researchregistry5752).",2020,"Our trial is to investigate whether the Yangxinshi (YXS) tablet can improve exercise tolerance as well as the quality of life among CHD patients.
","['90 patients with CHD from 3 hospitals in China', 'patients with coronary heart disease (CHD', 'patients with coronary heart disease', 'CHD patients', 'patients with CHD']","['Yangxinshi (YXS) tablet', 'Yangxinshi tablet', 'TCM', 'TCM YXS tablet', 'YXS group, N\u200a=\u200a45; placebo', 'standardized western medicine and exercise-based cardiac rehabilitation program', 'traditional Chinese medicine (TCM', 'placebo']","['symptom improvement, psychologic issues, laboratory tests, side effects, and adverse events', 'exercise tolerance', 'exercise capacity, which will be evaluated by the cardiopulmonary exercise test and 6-minute walking test']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C4742319', 'cui_str': 'Yangxinshi tablet'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C4742318', 'cui_str': 'Yangxinshi'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",90.0,0.531614,"Our trial is to investigate whether the Yangxinshi (YXS) tablet can improve exercise tolerance as well as the quality of life among CHD patients.
","[{'ForeName': 'Sisi', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Cardiovascular and Cardiac Rehabilitation Department, First Affiliated Hospital of Changchun Chinese Medicine University, Changchun City, Jilin Province.'}, {'ForeName': 'Congying', 'Initials': 'C', 'LastName': 'Liang', 'Affiliation': 'Cardiovascular and Cardiac Rehabilitation Department, First Affiliated Hospital of Changchun Chinese Medicine University, Changchun City, Jilin Province.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Cardiovascular and Cardiac Rehabilitation Department, First Affiliated Hospital of Changchun Chinese Medicine University, Changchun City, Jilin Province.'}, {'ForeName': 'Zhijia', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Cardiovascular and Cardiac Rehabilitation Department, First Affiliated Hospital of Changchun Chinese Medicine University, Changchun City, Jilin Province.'}, {'ForeName': 'Jiaojiao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Operating Room Department, Feicheng Mining Bureau Central Hospital, Tai'an City, Shandong Province, China.""}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Cardiovascular and Cardiac Rehabilitation Department, First Affiliated Hospital of Changchun Chinese Medicine University, Changchun City, Jilin Province.'}]",Medicine,['10.1097/MD.0000000000021485']
1828,32755419,Blast exposure results in tau and neurofilament light chain changes in peripheral blood.,"OBJECTIVES


To evaluate how blast exposure impacts peripheral biomarkers.
in military personnel enrolled in 10-day blast training.
METHODS


On day 7, 21 military personnel experienced peak overpressure <2 pounds per square inch (psi); while 29 military personnel experienced peak overpressure ≥5 psi. Blood samples were collected each day to measure changes in amyloid beta (Aβ), neurofilament light chain (NFL), and tau concentrations.
RESULTS


Within 24 hours following exposure ≥5 psi, the ≥5 psi group had lower Aβ42 ( p  = .004) and NFL ( p  < .001) compared to the <2 psi group and lower Aβ42 (9.35%) and NFL (22.01%) compared to baseline. Twenty-four hours after ≥5 psi exposure, the ≥5 psi group had lower tau ( p  < .001) and NFL ( p  < .001) compared to the <2 psi group and baseline. Seventy-two hours after exposure ≥5 psi, tau increased in the ≥5 psi group compared to the <2 psi group ( p  = .02) and baseline. The tau:Aβ42 ratio 24 hours after blast ( p  = .012), and the Aβ40:Aβ42 ratio 48 hours after blast ( p  = .04) differed in the ≥5 psi group compared to the <2 psi group.
CONCLUSIONS


These findings provide an initial report of acute alterations in biomarker concentrations following blast exposure.",2020,"The tau:Aβ42 ratio 24 hours after blast ( p  = .012), and the Aβ40:Aβ42 ratio 48 hours after blast ( p  = .04) differed in the ≥5 psi group compared to the <2 psi group.
",['military personnel enrolled in 10-day blast training'],[],"['peripheral blood', 'neurofilament light chain (NFL), and tau concentrations', 'NFL', 'amyloid beta ']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],"[{'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002716', 'cui_str': 'Amyloid Substance'}, {'cui': 'C0330390', 'cui_str': 'Beta'}]",,0.0370886,"The tau:Aβ42 ratio 24 hours after blast ( p  = .012), and the Aβ40:Aβ42 ratio 48 hours after blast ( p  = .04) differed in the ≥5 psi group compared to the <2 psi group.
","[{'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'Edwards', 'Affiliation': 'National Institute of Nursing Research, National Institutes of Health , Bethesda, MD, USA.'}, {'ForeName': 'Jacqueline J', 'Initials': 'JJ', 'LastName': 'Leete', 'Affiliation': 'National Institute of Nursing Research, National Institutes of Health , Bethesda, MD, USA.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Tschiffely', 'Affiliation': 'Department of Neurotrauma, Naval Medical Research Center , Silver Spring, MD, USA.'}, {'ForeName': 'Candace Y', 'Initials': 'CY', 'LastName': 'Moore', 'Affiliation': 'National Institute of Nursing Research, National Institutes of Health , Bethesda, MD, USA.'}, {'ForeName': 'Kristine C', 'Initials': 'KC', 'LastName': 'Dell', 'Affiliation': 'Department of Psychology, Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Jonathan K', 'Initials': 'JK', 'LastName': 'Statz', 'Affiliation': 'Henry M. Jackson Foundation, Bethesda, MD, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Carr', 'Affiliation': 'Oak Ridge Institute for Science and Education, Oak Ridge, TN, USA.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Walker', 'Affiliation': 'Joint Artificial Intelligence Center, Arlington, VA, USA.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'LoPresti', 'Affiliation': 'Center for Military Psychiatry & Neuroscience, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Ahlers', 'Affiliation': 'Operational & Undersea Medicine Directorate, Naval Medical Research Center, Silver Spring, MD, USA.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Yarnell', 'Affiliation': 'Operational & Undersea Medicine Directorate, Naval Medical Research Center, Silver Spring, MD, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gill', 'Affiliation': 'National Institute of Nursing Research, National Institutes of Health , Bethesda, MD, USA.'}]",Brain injury,['10.1080/02699052.2020.1797171']
1829,32755802,Distance to white matter trajectories is associated with treatment response to internal capsule deep brain stimulation in treatment-refractory depression.,"BACKGROUND


Deep brain stimulation (DBS) is an innovative treatment for treatment-refractory depression. DBS is usually targeted at specific anatomical landmarks, with patients responding to DBS in approximately 50% of cases. Attention has recently shifted to white matter tracts to explain DBS response, with initial open-label trials targeting white matter tracts yielding much higher response rates (>70%).
OBJECTIVE/HYPOTHESIS


Our aim was to associate distance to individual white matter tracts around the stimulation target in the ventral anterior limb of the internal capsule to treatment response.
METHODS


We performed diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation in fourteen patients that participated in our randomized clinical trial. We combined the tract reconstructions with the postoperative images to identify the DBS leads and estimated the distance between tracts and leads, which we subsequently associated with treatment response.
RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial. Biophysical modelling indicated that 37.5% of tracts were even outside the volume of activated tissue. There was no difference in lead placement with respect to anatomical landmarks, which could mean that differences in treatment response were driven by individual differences in white matter anatomy.
CONCLUSIONS


Our results suggest that deep brain stimulation of the ventral anterior limb of the internal capsule could benefit from targeting white matter bundles. We recommend acquiring diffusion magnetic resonance data for each individual patient.",2020,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.",['fourteen patients that participated in our randomized clinical trial'],"['DBS', 'Deep brain stimulation (DBS', 'diffusion magnetic resonance tractography of the superolateral branch of the medial forebrain bundle and the anterior thalamic radiation']",['lead placement'],"[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0025055', 'cui_str': 'Structure of median forebrain bundle'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0039729', 'cui_str': 'Thalamic structure'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",,0.085274,"RESULTS


Stimulation closer to both tracts was significantly correlated to a larger symptom decrease (r = 0.61, p = 0.02), suggesting that stimulation more proximal to the tracts was beneficial.","[{'ForeName': 'Luka C', 'Initials': 'LC', 'LastName': 'Liebrand', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands. Electronic address: L.C.Liebrand@amsterdamumc.nl.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Natarajan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Matthan W A', 'Initials': 'MWA', 'LastName': 'Caan', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Biomedical Engineering and Physics, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'P Richard', 'Initials': 'PR', 'LastName': 'Schuurman', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Pepijn', 'Initials': 'P', 'LastName': 'van den Munckhof', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Neurosurgery, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'de Kwaasteniet', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Luigjes', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Isidoor O', 'Initials': 'IO', 'LastName': 'Bergfeld', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}, {'ForeName': 'Damiaan', 'Initials': 'D', 'LastName': 'Denys', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands; Netherlands Institute for Neuroscience, Royal Academy of Arts and Sciences, Meibergdreef 47, Amsterdam, Netherlands.'}, {'ForeName': 'Guido A', 'Initials': 'GA', 'LastName': 'van Wingen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Psychiatry, Amsterdam Neuroscience, Meibergdreef 9, Amsterdam, Netherlands; Amsterdam Brain and Cognition, Nieuwe Achtergracht 129 B, Amsterdam, Netherlands.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102363']
1830,32761068,Guidelines for the Management of Severe Traumatic Brain Injury: 2020 Update of the Decompressive Craniectomy Recommendations.,"When the fourth edition of the Brain Trauma Foundation's Guidelines for the Management of Severe Traumatic Brain Injury were finalized in late 2016, it was known that the results of the RESCUEicp (Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension) randomized controlled trial of decompressive craniectomy would be public after the guidelines were released. The guideline authors decided to proceed with publication but to update the decompressive craniectomy recommendations later in the spirit of ""living guidelines,"" whereby topics are updated more frequently, and between new editions, when important new evidence is published. The update to the decompressive craniectomy chapter presented here integrates the findings of the RESCUEicp study as well as the recently published 12-mo outcome data from the DECRA (Decompressive Craniectomy in Patients With Severe Traumatic Brain Injury) trial. Incorporation of these publications into the body of evidence led to the generation of 3 new level-IIA recommendations; a fourth previously presented level-IIA recommendation remains valid and has been restated. To increase the utility of the recommendations, we added a new section entitled Incorporating the Evidence into Practice. This summary of expert opinion provides important context and addresses key issues for practitioners, which are intended to help the clinician utilize the available evidence and these recommendations. The full guideline can be found at: https://braintrauma.org/guidelines/guidelines-for-the-management-of-severe-tbi-4th-ed#/.",2020,"When the fourth edition of the Brain Trauma Foundation's Guidelines for the Management of Severe Traumatic Brain Injury were finalized in late 2016, it was known that the results of the RESCUEicp (Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension) randomized controlled trial of decompressive craniectomy would be public after the guidelines were released.",['Patients With Severe Traumatic Brain Injury) trial'],"['DECRA (Decompressive Craniectomy', 'decompressive craniectomy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C2717817', 'cui_str': 'Decompressive craniectomy'}]",[],,0.0441026,"When the fourth edition of the Brain Trauma Foundation's Guidelines for the Management of Severe Traumatic Brain Injury were finalized in late 2016, it was known that the results of the RESCUEicp (Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension) randomized controlled trial of decompressive craniectomy would be public after the guidelines were released.","[{'ForeName': 'Gregory W J', 'Initials': 'GWJ', 'LastName': 'Hawryluk', 'Affiliation': 'Section of Neurosurgery, GB1-Health Sciences Centre, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Rubiano', 'Affiliation': 'INUB-MEDITECH Research Group, Universidad El Bosque, Bogota, Colombia.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Totten', 'Affiliation': 'Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': ""O'Reilly"", 'Affiliation': 'Oregon Health & Science University, Portland, Oregon.'}, {'ForeName': 'Jamie S', 'Initials': 'JS', 'LastName': 'Ullman', 'Affiliation': 'Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Bratton', 'Affiliation': 'University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Chesnut', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Odette A', 'Initials': 'OA', 'LastName': 'Harris', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Kissoon', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Shutter', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Tasker', 'Affiliation': ""Harvard Medical School & Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Monica S', 'Initials': 'MS', 'LastName': 'Vavilala', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Wilberger', 'Affiliation': 'Drexel University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Wright', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lumba-Brown', 'Affiliation': 'Stanford University, Stanford, California.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Ghajar', 'Affiliation': 'Stanford University, Stanford, California.'}]",Neurosurgery,['10.1093/neuros/nyaa278']
1831,32757825,"Strong Men, Strong Communities: Design of a Randomized Controlled Trial of a Diabetes Prevention Intervention for American Indian and Alaska Native Men.","Type 2 diabetes is a serious global epidemic that disproportionately affects disadvantaged populations. American Indians and Alaska Natives (AIs/ANs) have the highest rates of diabetes in the nation with a prevalence of 14.7% in 2018, more than twice that of non-Hispanic Whites. AI/AN men have the highest prevalence of diagnosed type 2 diabetes (14.5%) compared to non-Hispanic Black (11.4%), non-Hispanic Asian (10.0%), and non-Hispanic White (8.6%) men. Several landmark clinical trials have shown that lifestyle interventions can effectively prevent or delay the onset of diabetes among those at risk, including in AIs/ANs. Despite positive outcomes for AIs/ANs in these studies, very few were men. To date, there have been no concerted efforts to recruit and retain AI/AN men in interventions that promote weight loss and healthy lifestyles to prevent diabetes, and they remain underrepresented in these types of studies. This article describes the design and methods of the first randomized controlled trial of a diabetes prevention program with a study sample comprised entirely of AI/AN men. Research to date has demonstrated suboptimal patterns of recruitment and retention of AI/AN men, resulting in their virtual absence in health and intervention research. Effective methods to recruit and retain AI/AN men, and potential benefit gained from participation in diabetes prevention research, are unknown for this population who experience a high prevalence of type 2 diabetes. The study design presented in this article offers promising insights to help remedy these important shortcomings in the science of recruitment and retention of AI/AN men in research.",2020,"AN men have the highest prevalence of diagnosed type 2 diabetes (14.5%) compared to non-Hispanic Black (11.4%), non-Hispanic Asian (10.0%), and non-Hispanic White (8.6%) men.","['AN men have the highest prevalence of diagnosed type 2 diabetes (14.5%) compared to non-Hispanic Black (11.4%), non-Hispanic Asian (10.0%), and non-Hispanic White (8.6%) men', 'diabetes prevention program with a study sample comprised entirely of AI/AN men', 'American Indian and Alaska Native Men']",['Diabetes Prevention Intervention'],[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0537682,"AN men have the highest prevalence of diagnosed type 2 diabetes (14.5%) compared to non-Hispanic Black (11.4%), non-Hispanic Asian (10.0%), and non-Hispanic White (8.6%) men.","[{'ForeName': ""Ka'imi"", 'Initials': 'K', 'LastName': 'Sinclair', 'Affiliation': 'College of Nursing, Initiative for Research and Education to Advance Community Health (IREACH), Washington State University, Seattle, WA, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Carty', 'Affiliation': 'Initiative for Research and Education to Advance Community Health (IREACH), Washington State University, Seattle, WA, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Gonzales', 'Affiliation': 'Portland State University-Oregon Health Sciences University Joint School of Public Health, Portland, OR, USA.'}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Nikolaus', 'Affiliation': 'Initiative for Research and Education to Advance Community Health (IREACH), Washington State University, Seattle, WA, USA.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Gillespie', 'Affiliation': 'Initiative for Research and Education to Advance Community Health (IREACH), Washington State University, Seattle, WA, USA.'}, {'ForeName': 'Dedra', 'Initials': 'D', 'LastName': 'Buchwald', 'Affiliation': 'Initiative for Research and Education to Advance Community Health (IREACH), Washington State University, Seattle, WA, USA.'}]",American journal of men's health,['10.1177/1557988320945457']
1832,32758298,"A phase II, single-center, double-blind, randomized placebo-controlled trial to explore the efficacy and safety of intravenous melatonin in patients with COVID-19 admitted to the intensive care unit (MelCOVID study): a structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES


• Primary objective: to evaluate the effect of intravenous melatonin (IVM) on mortality in adult patients admitted to the intensive care unit (ICU) with COVID-19. • Secondary objectives: ◦ To evaluate the effect of IVM on ICU length of stay. ◦ To evaluate the effect of IVM on the length of mechanical ventilation (MV). ◦ To evaluate if the use of IVM is associated with an increase in the number of ventilator-free days. ◦ To evaluate if the use of IVM is associated with a reduced number of failing organs as determined by the sequential organ failure assessment (SOFA) scale. ◦ To evaluate if the use of IVM is associated with a reduction of the frequency and severity of COVID-19-associated thromboembolic phenomena. ◦ To evaluate if the use of IVM is associated with a decreased systemic inflammatory response assessed by plasma levels of ferritin, D-dimer, C-reactive protein, procalcitonin and interleukin-6. ◦ To evaluate if the use of IVM is associated with an improvement in hematologic parameters. ◦ To evaluate if the use of IVM is associated with an improvement in biochemical parameters. ◦ To evaluate if the use of IVM is associated with an improvement in blood gas analysis parameters. ◦ To evaluate adverse events during the 28 day study period.
TRIAL DESIGN


Phase II, single center, double-blind, placebo-controlled randomized trial with a two-arm parallel group design and 2:1 allocation ratio.
PARTICIPANTS


Only critically ill adult patients that fulfill all of the inclusion criteria and none of the exclusion criteria will be included. The study will be conducted in a mixed ICU of a publicly funded tertiary referral center in Madrid, Spain with a 30-bed capacity and 1100 admissions per year. • Inclusion criteria: ◦ Patient, family member or legal guardian has provided written Informed Consent. ◦ Age ε 18 years. ◦ Confirmed SARS-CoV-2 infection with compatible symptoms AND a positive RT-PCR. ◦ Admission to the ICU with acute hypoxemic respiratory failure attributed to SARS-CoV-2 infection. ◦ ICU length of stay of less than 7 days prior to randomization with or without MV and without signs of improvement in respiratory failure (MURRAY score at randomization greater or equal to the MURRAY score at ICU admission). • Exclusion criteria: ◦ Participant in a different COVID-19 study in which the study drug is under clinical development and hasn't been previously authorized for commercialization. ◦ Liver enzymes > 5 times the upper normal range. ◦ Chronic kidney disease with GFR < 30 mL/min/1.73 m 2  (stage 4 or greater) or need for hemodialysis. ◦ Pregnancy. A pregnancy test will be performed on every woman younger than 55 years of age prior to inclusion. ◦ Terminal surgical or medical illness. ◦ Autoimmune disease. ◦ Any patient condition that can prevent the study procedures to be carried out at the treating physician's judgement.
INTERVENTION AND COMPARATOR


All patients will receive standard-of-care treatment according to the current institutional protocols. In addition, patients will be randomized in a 2:1 ratio to receive: • Experimental group (12 patients): 7 days of 5 mg per Kg of actual body weight per day of intravenous melatonin every 6 hours. Maximum daily dose 500 mg per day. • Control group (6 patients): 7 days of 5 mg per Kg of actual body weight per day of intravenous identically-looking placebo every 6 hours. After 3 days of treatment, 3 intensive care physicians will evaluate the participant and decide whether or not to complete the treatment based on their clinical assessment: • If objective or subjective signs of improvement or no worsening of the general clinical condition, respiratory failure, inflammatory state or multi-organ failure are observed, the participant will continue the treatment until completion. • If an adverse effect or clinical impairment is observed that is objectively or subjectively attributable to the study drug the treatment will be stopped.
MAIN OUTCOME


Mortality in each study group represented in frequency and time-to-event at day 28 after randomization RANDOMIZATION: The randomization sequence was created using SAS version 9.4 statistical software (programmed and validated macros) with a 2:1 allocation. No randomization seed was pre-specified. The randomization seed was generated using the time on the computer where the program was executed.
BLINDING (MASKING)


Participants, caregivers and study groups will be blinded to arm allocation.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


A total of 18 patients will be randomized in this trial: 12 to the experimental arm and 6 to the control arm.
TRIAL STATUS


Protocol version 2.0, June 5 th  2020. Trial status: recruitment not started. The first patient is expected to be recruited in October 2020. The last patient is anticipated to be recruited in August 2021.
TRIAL REGISTRATION


EU Clinical Trials Register. Date of trial registration: 10 July 2020. URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001808-42/ES FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"◦ To evaluate if the use of IVM is associated with a decreased systemic inflammatory response assessed by plasma levels of ferritin, D-dimer, C-reactive protein, procalcitonin and interleukin-6.","['Protocol version 2.0, June 5 th  2020', 'mixed ICU of a publicly funded tertiary referral center in Madrid, Spain with a 30-bed capacity and 1100 admissions per year', '18 patients', 'adult patients admitted to the intensive care unit (ICU) with COVID-19', 'patients with COVID-19 admitted to the intensive care unit (MelCOVID study', '◦ Chronic kidney disease with GFR', 'every woman younger than 55 years of age prior to inclusion', 'Only critically ill adult patients that fulfill all of the inclusion criteria and none of the exclusion criteria will be included']","['intravenous melatonin (IVM', 'intravenous melatonin', 'IVM', 'intravenous identically-looking placebo', 'placebo']","['frequency and time-to-event', 'length of mechanical ventilation (MV', 'ICU length of stay', 'general clinical condition, respiratory failure, inflammatory state or multi-organ failure', 'respiratory failure (MURRAY score', 'efficacy and safety', 'plasma levels of ferritin, D-dimer, C-reactive protein, procalcitonin and interleukin-6', 'adverse events']","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C4517537', 'cui_str': '1100'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C1318304', 'cui_str': 'With GFR'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",18.0,0.248881,"◦ To evaluate if the use of IVM is associated with a decreased systemic inflammatory response assessed by plasma levels of ferritin, D-dimer, C-reactive protein, procalcitonin and interleukin-6.","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Rodríguez-Rubio', 'Affiliation': 'Pediatric Intensive Care Department, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Juan Carlos', 'Initials': 'JC', 'LastName': 'Figueira', 'Affiliation': 'Intensive Care Medicine Department, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Darío', 'Initials': 'D', 'LastName': 'Acuña-Castroviejo', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Biomedical Research Center, Health Science Technology Park, University of Granada, Granada, Spain.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Borobia', 'Affiliation': 'Clinical Pharmacology Department, Clinical Trial Unit, Hospital Universitario La Paz - IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Germaine', 'Initials': 'G', 'LastName': 'Escames', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Biomedical Research Center, Health Science Technology Park, University of Granada, Granada, Spain. gescames@ugr.es.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'de la Oliva', 'Affiliation': 'Pediatric Intensive Care Department, Hospital Universitario La Paz, Madrid, Spain. pedro.oliva@salud.madrid.org.'}]",Trials,['10.1186/s13063-020-04632-4']
1833,32759251,"Ursodeoxycholic acid as a novel disease-modifying treatment for Parkinson's disease: protocol for a two-centre, randomised, double-blind, placebo-controlled trial, The 'UP' study.","INTRODUCTION


There are no disease-modifying treatments for Parkinson's disease (PD). We undertook the first drug screen in PD patient tissue and idntified ursodeoxycholic acid (UDCA) as a promising mitochondrial rescue agent. The aims of this trial are to determine safety and tolerability of UDCA in PD at 30 mg/kg, confirm the target engagement of UDCA, apply a novel motion sensor-based approach to quantify disease progression objectively, and estimate the mean effect size and its variance on the change in motor severity.
METHODS AND ANALYSIS


This is a phase II, two-centre, double-blind, randomised, placebo-controlled trial of UDCA at a dose of 30 mg/kg in 30 participants with early PD. Treatment duration is 48 weeks, followed by an 8-week washout phase. Randomisation is 2:1, drug to placebo. Assessments are performed at baseline, week 12, 24, 36, 48 and 56. The primary outcome is safety and tolerability. Secondary outcomes will compare the change between baseline and week 48 using the following three approaches: the Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 in the practically defined 'OFF' medication state; confirmation of target engagement, applying  31 Phosphorus MR Spectroscopy to assess the levels of ATP and relevant metabolites in the brain; and objective quantification of motor impairment, using a validated, motion sensor-based approach. The primary outcome will be reported using descriptive statistics and comparisons between treatment groups. For each secondary outcome, the change from baseline will be summarised within treatment groups using summary statistics and appropriate statistical tests assessing for significant differences. All outcomes will use an intention-to-treat analysis population.
ETHICS AND DISSEMINATION


This trial has been approved by the East of England - Cambridgeshire and Hertfordshire Research Ethics committee. Results will be disseminated in peer-reviewed journals, presentations at scientific meetings and to patients in a lay-summary format.
TRIAL REGISTRATION NUMBER


NCT03840005.",2020,"This is a phase II, two-centre, double-blind, randomised, placebo-controlled trial of UDCA at a dose of 30 mg/kg in 30 participants with early PD.","[""Parkinson's disease"", '30 participants with early PD']","['Ursodeoxycholic acid', 'UDCA', 'ursodeoxycholic acid (UDCA', 'placebo']","[""Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 in the practically defined 'OFF' medication state; confirmation of target engagement, applying  31 Phosphorus MR Spectroscopy to assess the levels of ATP and relevant metabolites in the brain; and objective quantification of motor impairment, using a validated, motion sensor-based approach"", 'safety and tolerability']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0042105', 'cui_str': 'ursodeoxycholic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0521091', 'cui_str': 'Confirmation of'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",30.0,0.546511,"This is a phase II, two-centre, double-blind, randomised, placebo-controlled trial of UDCA at a dose of 30 mg/kg in 30 participants with early PD.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Payne', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Sassani', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Buckley', 'Affiliation': 'NIHR Sheffield Biomedical Research Centre, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Moll', 'Affiliation': 'NIHR Sheffield Biomedical Research Centre, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Anton', 'Affiliation': 'NIHR Sheffield Biomedical Research Centre, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Appleby', 'Affiliation': 'Department of Clinical and Movement Neurosciences, University College London Institute of Neurology, London, UK.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Maru', 'Affiliation': 'Department of Clinical and Movement Neurosciences, University College London Institute of Neurology, London, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Statistical Services Unit, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Alisdair', 'Initials': 'A', 'LastName': 'McNeill', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hoggard', 'Affiliation': 'Academic Unit of Radiology, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Mazza', 'Affiliation': 'Institute for In Silico Medicine, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Iain D', 'Initials': 'ID', 'LastName': 'Wilkinson', 'Affiliation': 'Academic Unit of Radiology, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jenkins', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, The University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Foltynie', 'Affiliation': 'Department of Clinical and Movement Neurosciences, University College London Institute of Neurology, London, UK.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Bandmann', 'Affiliation': 'Sheffield Institute for Translational Neuroscience, The University of Sheffield, Sheffield, UK o.bandmann@sheffield.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2020-038911']
1834,32759285,Freeze-all versus fresh blastocyst transfer strategy during in vitro fertilisation in women with regular menstrual cycles: multicentre randomised controlled trial.,"OBJECTIVE


To compare the ongoing pregnancy rate between a freeze-all strategy and a fresh transfer strategy in assisted reproductive technology treatment.
DESIGN


Multicentre, randomised controlled superiority trial.
SETTING


Outpatient fertility clinics at eight public hospitals in Denmark, Sweden, and Spain.
PARTICIPANTS


460 women aged 18-39 years with regular menstrual cycles starting their first, second, or third treatment cycle of in vitro fertilisation or intracytoplasmic sperm injection.
INTERVENTIONS


Women were randomised at baseline on cycle day 2 or 3 to one of two treatment groups: the freeze-all group (elective freezing of all embryos) who received gonadotropin releasing hormone agonist triggering and single frozen-thawed blastocyst transfer in a subsequent modified natural cycle; or the fresh transfer group who received human chorionic gonadotropin triggering and single blastocyst transfer in the fresh cycle. Women in the fresh transfer group with more than 18 follicles larger than 11 mm on the day of triggering had elective freezing of all embryos and postponement of transfer as a safety measure.
MAIN OUTCOME MEASURES


The primary outcome was the ongoing pregnancy rate defined as a detectable fetal heart beat after eight weeks of gestation. Secondary outcomes were live birth rate, positive human chorionic gonadotropin rate, time to pregnancy, and pregnancy related, obstetric, and neonatal complications. The primary analysis was performed according to the intention-to-treat principle.
RESULTS


Ongoing pregnancy rate did not differ significantly between the freeze-all and fresh transfer groups (27.8% (62/223)  v  29.6% (68/230); risk ratio 0.98, 95% confidence interval 0.87 to 1.10, P=0.76). Additionally, no significant difference was found in the live birth rate (27.4% (61/223) for the freeze-all group and 28.7% (66/230) for the fresh transfer group; risk ratio 0.98, 95% confidence interval 0.87 to 1.10, P=0.83). No significant differences between groups were observed for positive human chorionic gonadotropin rate or pregnancy loss, and none of the women had severe ovarian hyperstimulation syndrome; only one hospital admission related to this condition occurred in the fresh transfer group. The risks of pregnancy related, obstetric, and neonatal complications did not differ between the two groups except for a higher mean birth weight after frozen blastocyst transfer and an increased risk of prematurity after fresh blastocyst transfer. Time to pregnancy was longer in the freeze-all group.
CONCLUSIONS


In women with regular menstrual cycles, a freeze-all strategy with gonadotropin releasing hormone agonist triggering for final oocyte maturation did not result in higher ongoing pregnancy and live birth rates than a fresh transfer strategy. The findings warrant caution in the indiscriminate application of a freeze-all strategy when no apparent risk of ovarian hyperstimulation syndrome is present.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02746562.",2020,"Ongoing pregnancy rate did not differ significantly between the freeze-all and fresh transfer groups (27.8% (62/223)  v  29.6% (68/230); risk ratio 0.98, 95% confidence interval 0.87 to 1.10, P=0.76).","['460 women aged 18-39 years with regular menstrual cycles starting their first, second, or third treatment cycle of in vitro fertilisation or intracytoplasmic sperm injection', 'women with regular menstrual cycles', 'Outpatient fertility clinics at eight public hospitals in Denmark, Sweden, and Spain']","['gonadotropin releasing hormone agonist triggering', 'freeze-all group (elective freezing of all embryos) who received gonadotropin releasing hormone agonist triggering and single frozen-thawed blastocyst transfer in a subsequent modified natural cycle; or the fresh transfer group who received human chorionic gonadotropin triggering and single blastocyst transfer in the fresh cycle', 'Freeze-all versus fresh blastocyst transfer strategy']","['ongoing pregnancy and live birth rates', 'mean birth weight', 'Ongoing pregnancy rate', 'ongoing pregnancy rate defined as a detectable fetal heart beat', 'Time to pregnancy', 'live birth rate, positive human chorionic gonadotropin rate, time to pregnancy, and pregnancy related, obstetric, and neonatal complications', 'live birth rate', 'risk of prematurity', 'risks of pregnancy related, obstetric, and neonatal complications', 'severe ovarian hyperstimulation syndrome', 'positive human chorionic gonadotropin rate or pregnancy loss']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C4760630', 'cui_str': 'Infertility Clinics'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0936221', 'cui_str': 'Blastocyst Transfer'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0015935', 'cui_str': 'Fetal Heart'}, {'cui': 'C3494204', 'cui_str': 'Time-to-Pregnancy'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0404588', 'cui_str': 'Finding related to risk factor in pregnancy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0085083', 'cui_str': 'Ovarian hyperstimulation syndrome'}, {'cui': 'C0156543', 'cui_str': 'Pregnancy with abortive outcome'}]",460.0,0.169415,"Ongoing pregnancy rate did not differ significantly between the freeze-all and fresh transfer groups (27.8% (62/223)  v  29.6% (68/230); risk ratio 0.98, 95% confidence interval 0.87 to 1.10, P=0.76).","[{'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Stormlund', 'Affiliation': 'Fertility Clinic, Department of Obstetrics and Gynaecology, Hvidovre University Hospital, Hvidovre, Kettegaard Allé 30, Copenhagen DK-2650, Denmark sacha.stormlund.01@regionh.dk.'}, {'ForeName': 'Negjyp', 'Initials': 'N', 'LastName': 'Sopa', 'Affiliation': 'Fertility Clinic, Department of Obstetrics and Gynaecology, Hvidovre University Hospital, Hvidovre, Kettegaard Allé 30, Copenhagen DK-2650, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zedeler', 'Affiliation': 'Fertility Clinic, Department of Obstetrics and Gynaecology, Hvidovre University Hospital, Hvidovre, Kettegaard Allé 30, Copenhagen DK-2650, Denmark.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Bogstad', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Prætorius', 'Affiliation': 'Fertility Clinic, Department of Obstetrics and Gynaecology, Hvidovre University Hospital, Hvidovre, Kettegaard Allé 30, Copenhagen DK-2650, Denmark.'}, {'ForeName': 'Henriette Svarre', 'Initials': 'HS', 'LastName': 'Nielsen', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Margaretha Laczna', 'Initials': 'ML', 'LastName': 'Kitlinski', 'Affiliation': 'Department of Reproductive Medicine, Skane University Hospital, Malmö, Sweden.'}, {'ForeName': 'Sven O', 'Initials': 'SO', 'LastName': 'Skouby', 'Affiliation': 'Fertility Clinic, Department of Obstetrics and Gynaecology, Herlev University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anne Lis', 'Initials': 'AL', 'LastName': 'Mikkelsen', 'Affiliation': 'Fertility Clinic, Department of Obstetrics and Gynaecology, Holbæk University Hospital, Holbæk, Denmark.'}, {'ForeName': 'Anne Lærke', 'Initials': 'AL', 'LastName': 'Spangmose', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Janni Vikkelsø', 'Initials': 'JV', 'LastName': 'Jeppesen', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Khatibi', 'Affiliation': 'Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Reproductive Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'la Cour Freiesleben', 'Affiliation': 'Fertility Clinic, Department of Obstetrics and Gynaecology, Hvidovre University Hospital, Hvidovre, Kettegaard Allé 30, Copenhagen DK-2650, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Ziebe', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Nikolaos P', 'Initials': 'NP', 'LastName': 'Polyzos', 'Affiliation': 'Department of Reproductive Medicine, Dexeus University Hospital, Barcelona, Spain.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bergh', 'Affiliation': 'Department of Obstetrics and Gynaecology, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, Reproductive Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Humaidan', 'Affiliation': 'Fertility Clinic, Skive Regional Hospital and Faculty of Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Anders Nyboe', 'Initials': 'AN', 'LastName': 'Andersen', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Løssl', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'Fertility Clinic, Department of Obstetrics and Gynaecology, Hvidovre University Hospital, Hvidovre, Kettegaard Allé 30, Copenhagen DK-2650, Denmark.'}]",BMJ (Clinical research ed.),['10.1136/bmj.m2519']
1835,32763021,Ketamine improves short-term plasticity in depression by enhancing sensitivity to prediction errors.,"Major depressive disorder negatively impacts the sensitivity and adaptability of the brain's predictive coding framework. The current electroencephalography study into the antidepressant properties of ketamine investigated the downstream effects of ketamine on predictive coding and short-term plasticity in thirty patients with depression using the auditory roving mismatch negativity (rMMN). The rMMN paradigm was run 3-4 h after a single 0.44 mg/kg intravenous dose of ketamine or active placebo (remifentanil infused to a target plasma concentration of 1.7 ng/mL) in order to measure the neural effects of ketamine in the period when an improvement in depressive symptoms emerges. Depression symptomatology was measured using the Montgomery-Asberg Depression Rating Scale (MADRS); 70% of patients demonstrated at least a 50% reduction their MADRS global score. Ketamine significantly increased the MMN and P3a event related potentials, directly contrasting literature demonstrating ketamine's acute attenuation of the MMN. This effect was only reliable when all repetitions of the post-deviant tone were used. Dynamic causal modelling showed greater modulation of forward connectivity in response to a deviant tone between right primary auditory cortex and right inferior temporal cortex, which significantly correlated with antidepressant response to ketamine at 24 h. This is consistent with the hypothesis that ketamine increases sensitivity to unexpected sensory input and restores deficits in sensitivity to prediction error that are hypothesised to underlie depression. However, the lack of repetition suppression evident in the MMN evoked data compared to studies of healthy adults suggests that, at least within the short term, ketamine does not improve deficits in adaptive internal model calibration.",2020,"Ketamine significantly increased the MMN and P3a event related potentials, directly contrasting literature demonstrating ketamine's acute attenuation of the MMN.",['thirty patients with depression using the auditory roving mismatch negativity (rMMN'],"['ketamine', 'Ketamine', 'ketamine or active placebo (remifentanil']","['Montgomery-Asberg Depression Rating Scale (MADRS', 'Depression symptomatology', 'MMN and P3a', 'MADRS global score']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0393847', 'cui_str': 'Motor neuropathy with multiple conduction block'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",30.0,0.0416165,"Ketamine significantly increased the MMN and P3a event related potentials, directly contrasting literature demonstrating ketamine's acute attenuation of the MMN.","[{'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Sumner', 'Affiliation': 'School of Pharmacy, University of Auckland, New Zealand. Electronic address: rsum009@aucklanduni.ac.nz.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'McMillan', 'Affiliation': 'School of Pharmacy, University of Auckland, New Zealand.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Spriggs', 'Affiliation': 'Centre for Psychedelic Research, Department of Medicine, Imperial College London, UK; Brain Research New Zealand; School of Psychology, University of Auckland, New Zealand.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Auckland District Health Board, New Zealand.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Malpas', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Auckland District Health Board, New Zealand.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Maxwell', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Auckland District Health Board, New Zealand.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Auckland District Health Board, New Zealand.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hay', 'Affiliation': 'Department of Anaesthesia and Perioperative Medicine, Auckland District Health Board, New Zealand.'}, {'ForeName': 'Rhys', 'Initials': 'R', 'LastName': 'Ponton', 'Affiliation': 'School of Pharmacy, University of Auckland, New Zealand.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Sundram', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, New Zealand.'}, {'ForeName': 'Suresh D', 'Initials': 'SD', 'LastName': 'Muthukumaraswamy', 'Affiliation': 'School of Pharmacy, University of Auckland, New Zealand.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2020.07.009']
1836,32763649,"Parenting, mental health and economic pathways to prevention of violence against children in South Africa.","BACKGROUND


Parenting programs based on social learning theory have increasing empirical evidence for reducing violence against children. Trials are primarily from high-income countries and with young children. Globally, we know little about how parenting programs work to reduce violence, with no known studies in low or middle-income countries (LMICs). This study examines mechanisms of change of a non-commercialized parenting program, Parenting for Lifelong Health for Teens, designed with the World Health Organization and UNICEF. A cluster randomized trial showed main effects on parenting and other secondary outcomes. We conducted secondary analysis of trial data to investigate five potential mediators of reduced violence against children: improved parenting, adolescent behaviour, caregiver mental health, alcohol/drug avoidance, and family economic strengthening.
METHODS


The trial was implemented in rural South Africa with 40 sites, n = 552 family dyads (including adolescents aged 10-18 and primary caregivers). Intervention sites (n = 20) received the 14-session parenting program delivered by local community members, including modules on family budgeting and savings. Control sites (n = 20) received a brief informational workshop. Emotional and physical violence against children/adolescents and each potential mediator were reported by adolescents and caregivers at baseline and 9-13 months post-randomisation. Structural equation modelling was used to test simultaneous hypothesized pathways to violence reduction.
RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare. Improved child behaviour was not a mediator, although it was associated with less violence.
CONCLUSIONS


Simultaneously bolstering a set of family processes can reduce violence. Supporting self-care and positive coping for caregivers may be essential in challenging contexts. In countries with minimal or no economic safety nets, linking social learning parenting programs with economic strengthening skills may bring us closer to ending violence against children.",2020,"RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare.","['rural South Africa with 40 sites, n\xa0=\xa0552 family dyads (including adolescents aged 10-18 and primary caregivers', 'reduced violence against children', 'Emotional and physical violence against children/adolescents', 'violence against children in South Africa', 'violence against children']","['brief informational workshop', '14-session parenting program delivered by local community members, including modules on family budgeting and savings']","['violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare', 'parenting, adolescent behaviour, caregiver mental health, alcohol/drug avoidance, and family economic strengthening', 'child behaviour']","[{'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1319883', 'cui_str': 'Primary caregiver'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0476480', 'cui_str': 'Physical violence'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0036245', 'cui_str': 'Savings'}]","[{'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",552.0,0.117351,"RESULTS


Improvements in four pathways mediated reduced violence against children: 1) improved parenting practices, 2) improved caregiver mental health (reduced depression), 3) increased caregiver alcohol/drug avoidance and 4) improved family economic welfare.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cluver', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Psychiatry and Mental Health, University of Cape Town, South Africa. Electronic address: lucie.cluver@spi.ox.ac.uk.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Shenderovich', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Institute of Criminology, University of Cambridge, United Kingdom. Electronic address: yulia.shenderovich@spi.ox.ac.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Meinck', 'Affiliation': 'School of Social and Political Science, University of Edinburgh, United Kingdom; Optentia, Faculty of Health Sciences, North-West University, South Africa. Electronic address: Franziska.Meinck@ed.ac.uk.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Berezin', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Applied Psychology, New York University, New York, USA. Electronic address: mnb387@nyu.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Doubt', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: jennydoubt@gmail.com.'}, {'ForeName': 'C L', 'Initials': 'CL', 'LastName': 'Ward', 'Affiliation': 'Department of Psychology, University of Cape Town, South Africa. Electronic address: Catherine.Ward@uct.ac.za.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Parra-Cardona', 'Affiliation': 'Steve Hicks School of Social Work, The University of Texas at Austin, Texas, USA. Electronic address: rparra@austin.utexas.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lombard', 'Affiliation': 'Biostatistics Unit, South African Medical Research Council, South Africa. Electronic address: carl.lombard@mrc.ac.za.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Lachman', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; MRC/CSO Social and Public Health Sciences Unit, University of Glasglow, United Kingdom. Electronic address: jamie.lachman@spi.ox.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wittesaele', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: camille.wittesaele@spi.ox.ac.uk.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Wessels', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; Department of Psychology, University of Cape Town, South Africa. Electronic address: inge.wessels@spi.ox.ac.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gardner', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom. Electronic address: frances.gardner@wolfson.ox.ac.uk.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Steinert', 'Affiliation': 'Centre for Evidence-Based Intervention, Department of Social Policy & Intervention, University of Oxford, United Kingdom; TUM School of Governance, Technical University of Munich, Germany. Electronic address: janina.steinert@tum.de.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.113194']
1837,32763776,Effect of brief encouragement to use twitter on knowledge of the critical-care literature by ICU residents: The randomized controlled IMKREASE trial.,,2020,,['ICU residents'],[],[],"[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]",[],[],,0.0232695,,"[{'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': 'Lascarrou', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Nantes, France. Electronic address: jeanbaptiste.lascarrou@chu-nantes.fr.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Tours, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Potier', 'Affiliation': 'Department of internal medicine, University Hospital Center, Nantes, France. Electronic address: pierre.potier@chu-nantes.fr.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Reignier', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Nantes, France. Electronic address: jean.reignier@chu-nantes.fr.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Canet', 'Affiliation': 'Medecine Intensive Reanimation, University Hospital Center, Nantes, France. Electronic address: emmanuel.canet@chu-nantes.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of critical care,['10.1016/j.jcrc.2020.07.022']
1838,32768993,The relationship between insomnia and the intensity of drinking in treatment-seeking individuals with alcohol dependence.,"BACKGROUND


Although insomnia is highly prevalent in alcohol use disorders(AUD), its associations with the severity of alcohol use, pre-existing psychiatric comorbidities and psychosocial problems are understudied. The present study evaluates the interplay between these factors using a structural equation model (SEM).
METHODS


We assessed baseline cross-sectional data on patients with AUD (N = 123) recruited to a placebo-controlled medication trial. Severity of alcohol use was measured by the Brief Michigan Alcoholism Screening Test (B-MAST). Insomnia Severity Index was used to assess insomnia symptoms. The Hamilton scales for Depression and Anxiety, Short Index of Problems and Timeline Follow Back evaluated psychiatric symptoms, psychosocial consequences of drinking and level of alcohol consumption respectively. We used logistic regression to evaluate the association between insomnia and severity of alcohol use while controlling for covariates. We constructed a SEM with observed variables to delineate the effect of psychiatric symptoms, psychosocial factors and current alcohol use on the pathway between alcohol use severity and insomnia.
RESULTS


The sample was predominately male(83.9 %), Black(54.6 %) and employed(60.0 %). About 45 % of the participants reported moderate-severe insomnia.The association between insomnia and B-MAST attenuated after adjustment for demographics, psychiatric symptoms and psychosocial problems(OR[95 % CI] = 1.17(0.99-1.47). SEM findings demonstrated that B-MAST and insomnia were linked to psychiatric symptoms (95 % Asymptotic-Confidence Interval (ACI): 0.015-0.159, p < 0.05) but not to psychosocial problems or current alcohol use.
CONCLUSION


Among treatment-seeking patients with AUD, psychiatric burden mediated the relationship between severity of alcohol use and insomnia. Clinicians should screen for underlying psychiatric disorders among treatment-seeking patients with AUD complaining of insomnia.",2020,"The association between insomnia and B-MAST attenuated after adjustment for demographics, psychiatric symptoms and psychosocial problems(OR[95 % CI] =","['patients with AUD (N = 123) recruited to a placebo-controlled medication trial', 'treatment-seeking patients with AUD', 'treatment-seeking patients with AUD complaining of insomnia', 'treatment-seeking individuals with alcohol dependence']",[],"['Hamilton scales for Depression and Anxiety, Short Index of Problems and Timeline Follow Back evaluated psychiatric symptoms, psychosocial consequences of drinking and level of alcohol consumption respectively', 'Insomnia Severity Index', 'insomnia symptoms', 'psychiatric symptoms', 'moderate-severe insomnia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439022', 'cui_str': 'Complaining of insomnia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",123.0,0.022062,"The association between insomnia and B-MAST attenuated after adjustment for demographics, psychiatric symptoms and psychosocial problems(OR[95 % CI] =","[{'ForeName': 'Ninad S', 'Initials': 'NS', 'LastName': 'Chaudhary', 'Affiliation': 'University of Alabama at Birmingham School of Public Health, 1665 University Blvd, Birmingham, AL, 35211, USA. Electronic address: ninadsc@uab.edu.'}, {'ForeName': 'Maria M', 'Initials': 'MM', 'LastName': 'Wong', 'Affiliation': 'Idaho State University, 921 S 8th Ave, Stop 8112, Pocatello, ID, 83209, USA.'}, {'ForeName': 'Bhanu Prakash', 'Initials': 'BP', 'LastName': 'Kolla', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, 2nd ST SW, Rochester, MN, 55905, USA.'}, {'ForeName': 'Kyle M', 'Initials': 'KM', 'LastName': 'Kampman', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, 3400 Civic Center Blvd, Philadelphia, PA, 19104, USA; Cpl. Michael J. Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, PA, 19104, USA.'}, {'ForeName': 'Subhajit', 'Initials': 'S', 'LastName': 'Chakravorty', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, 3400 Civic Center Blvd, Philadelphia, PA, 19104, USA; Cpl. Michael J. Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, PA, 19104, USA. Electronic address: Subhajit.Chakravorty@uphs.upenn.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108189']
1839,32769027,Does CPAP treat depressive symptoms in individuals with OSA? An analysis of two 12-week randomized sham CPAP-controlled trials.,"BACKGROUND


Depression is common in patients with obstructive sleep apnea (OSA). Whether treating OSA with continuous positive airway pressure (CPAP) improves depressive symptoms remains inconclusive. We examined the impact of CPAP on depressive symptoms in OSA patients compared to sham CPAP.
METHODS


A sub-analysis of two previous randomized sham-controlled trials was conducted. 126 male OSA patients (age = 51 ± 11 years; BMI = 32.0 ± 5.1 kg/m 2 ; apnea hypopnea index = 42.4 ± 22.6 events/hour) were randomised either to therapeutic CPAP (n = 65) or sham CPAP (n = 61). Depressive symptoms were measured using the Depression, Anxiety and Stress Scale (DASS). The main outcome was the change in the DASS depression score (DASSD) after three months between the therapeutic and sham CPAP arms.
RESULTS


The change in DASSD at three months did not differ between therapeutic and sham CPAP (mean difference: 0.5, 95% CI -3.6 to 4.6, p = 0.80). There was no significant between-group differences within the sub-groups of adherent users (device usage≥4hrs/day), or those with baseline depression (DASSD>9). In a secondary analysis of patients with baseline depression, adherent therapeutic CPAP use was associated with a greater reduction in DASSD scores compared to non-adherers (-10.0, 95% CI -18.3 to -1.8, p = 0.019).
CONCLUSIONS


Overall, three months of CPAP did not significantly improve depression scores in OSA patients. Adherent use of therapeutic CPAP in patients with baseline depressive symptoms was associated with a reduction in symptom score. Future trials involving OSA patients with higher depressive symptoms will enable us to understand the complex interaction between OSA and depression.",2020,"There was no significant between-group differences within the sub-groups of adherent users (device usage≥4hrs/day), or those with baseline depression (DASSD>9).","['OSA patients with higher depressive symptoms', '126 male OSA patients (age\xa0=\xa051\xa0±\xa011 years; BMI\xa0=\xa032.0\xa0±\xa05.1\xa0kg/m 2 ; apnea hypopnea index\xa0=\xa042.4\xa0±\xa022.6 events/hour', 'patients with baseline depressive symptoms', 'individuals with OSA', 'OSA patients', 'patients with obstructive sleep apnea (OSA']","['OSA with continuous positive airway pressure (CPAP', 'sham CPAP', 'CPAP', 'therapeutic CPAP']","['depression scores', 'Depression, Anxiety and Stress Scale (DASS', 'change in DASSD', 'Depressive symptoms', 'DASSD scores', 'DASS depression score (DASSD', 'depressive symptoms']","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",126.0,0.313538,"There was no significant between-group differences within the sub-groups of adherent users (device usage≥4hrs/day), or those with baseline depression (DASSD>9).","[{'ForeName': 'Yingjuan', 'Initials': 'Y', 'LastName': 'Mok', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia; Department of Sleep Medicine, Surgery and Science, Department of Respiratory and Critical Care Medicine, Changi General Hospital, Singapore.'}, {'ForeName': 'Kerri L', 'Initials': 'KL', 'LastName': 'Melehan', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Craig L', 'Initials': 'CL', 'LastName': 'Phillips', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Brendon J', 'Initials': 'BJ', 'LastName': 'Yee', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Miller', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ronald R', 'Initials': 'RR', 'LastName': 'Grunstein', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Bartlett', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'The Lundquist Institute of Biomedical Innovation at Harbor-UCLA Medical Center Torrance, California, USA.'}, {'ForeName': 'Keith K', 'Initials': 'KK', 'LastName': 'Wong', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Camilla M', 'Initials': 'CM', 'LastName': 'Hoyos', 'Affiliation': 'Centre for Sleep and Chronobiology,(CIRUS), Woolcock Institute of Medical Research, University of Sydney, Glebe, Australia; School of Psychology, Brain and Mind Centre and Charles Perkins Centre, University of Sydney, Sydney, NSW, Australia. Electronic address: camilla.hoyos@sydney.edu.au.'}]",Sleep medicine,['10.1016/j.sleep.2020.04.021']
1840,32769065,The effects of foot reflexology on agitation and extubation time in male patients following coronary artery bypass surgery: A randomized controlled clinical trial.,"BACKGROUND AND PURPOSE


This study examined the effects of foot reflexology on agitation and extubation time of male patients following coronary artery bypass graft surgery.
MATERIALS AND METHODS


In this randomized three-arm controlled clinical trial, participants (n = 120) were randomly assigned to the intervention, placebo, or control groups. The intervention group received foot reflexology massage for 15 min. Agitation was assessed using the Richmond Agitation- Sedation Scale before the intervention (Time 1) and immediately (Time 2) and 10 min after the intervention (Time 3). Extubation time was measured as the time from gaining full consciousness to endotracheal extubation.
RESULTS


Agitation reduced in all groups from Time 1 to Time 3 (p < 0.05); however, the intervention group showed a significantly higher reduction at Time 2 (p < 0.001) and Time 3 (p < 0.001). Also, extubation time was significantly shorter in the intervention group (p < 0.01).
CONCLUSION


Foot reflexology may be introduced as a nursing intervention to facilitate the weaning process in the cardiac ICUs.",2020,"RESULTS


Agitation reduced in all groups from Time 1 to Time 3 (p < 0.05); however, the intervention group showed a significantly higher reduction at Time 2 (p < 0.001) and Time 3 (p < 0.001).","['male patients following coronary artery bypass surgery', 'male patients following coronary artery bypass graft surgery', 'participants (n\xa0=\xa0120']","['foot reflexology', 'foot reflexology massage', 'placebo']","['agitation and extubation time', 'Extubation time', 'extubation time', 'Richmond Agitation- Sedation Scale', 'Agitation']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034945', 'cui_str': 'Reflexology'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}]",120.0,0.0559303,"RESULTS


Agitation reduced in all groups from Time 1 to Time 3 (p < 0.05); however, the intervention group showed a significantly higher reduction at Time 2 (p < 0.001) and Time 3 (p < 0.001).","[{'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Allahbakhhsian', 'Affiliation': 'Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Gholizadeh', 'Affiliation': 'IMPACCT, Faculty of Health, University of Technology Sydney, Sydney, Australia. Electronic address: Leila.gholizadeh@uts.edu.au.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Allahbakhshian', 'Affiliation': 'Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences. Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Sarbakhsh', 'Affiliation': 'Faculty of Public Health, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Abbaszadeh', 'Affiliation': 'Faculty of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: abbaszadeh_yaser@yahoo.com.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101201']
1841,32771032,"Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment (PROTECT) of Hydroxychloroquine, Oseltamivir and Azithromycin to treat newly diagnosed patients with COVID-19 infection who have no comorbidities like diabetes mellitus: A structured summary of a study protocol for a randomized controlled trial.","OBJECTIVES


To evaluate the effectiveness of Hydroxychloroquine Phosphate/Sulfate (200 mg orally 8 hourly thrice a day for 5 days), versus oseltamivir (75 mg orally twice a day for 5 days), and versus Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5) alone and in combination (in all seven groups), in clearing the coronavirus (COVID-19) nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes).
TRIAL DESIGN


An adaptive design, set within a comprehensive cohort study, to permit flexibility in this fast-changing clinical and public health scenario. The randomized study will be a multicenter, multiarm, multistage, randomized controlled trial with a parallel design. An observation only cohort will emerge from those not consenting to randomization.
PARTICIPANTS


Eligible will be newly diagnosed patients, either hospitalized or in self-isolation, without any comorbidities or with controlled chronic medical conditions like diabetes mellitus and hypertension. Participants of any gender or age group having tested positive for COVID-19 on Real-Time qRT-PCR (Quantitative Reverse Transcription PCR) will be invited to take part in study at twelve centers across eight cities in Pakistan. Those pregnant or lactating, severely dyspneic or with respiratory distress, already undergoing treatment, and with serious comorbidities like liver or kidney failure will be excluded.
INTERVENTION AND COMPARATOR


There will be a total of seven comparator groups: Each drug (Hydroxychloroquine Phosphate/Sulfate, Oseltamivir and Azithromycin) given as monotherapy (three groups); combinations of each of two drugs (three groups); and a final group on triple drug regimen.
MAIN OUTCOMES


The laboratory-based primary outcome will be turning the test negative for COVID-19 on qRT-PCR on day 7 of follow-up. The clinical primary outcome will be improvement from baseline of two points on a seven-category ordinal scale of clinical status on day 7 of follow-up.
RANDOMIZATION


Participants will be randomized, maintaining concealment of allocation sequence, using a computer-generated random number list of variable block size into multiple intervention groups in the allocation ratio of 1:1 for all groups.
BLINDING (MASKING)


This is an open label study, neither physician nor participants will be blinded.
NUMBERS TO BE RANDOMIZED (SAMPLE SIZE)


This is an adaptive design and parameters for formal sample size calculation in a new disease of a previously unknown virus are not available. Thus, the final sample size will be subjected to periodic reviews at each stage of adaptive design and subsequent advice of National Data Safety & Management Board (NDSMB) notified by Drug Regulatory Authority of Pakistan.
TRIAL STATUS


Protocol Version 1.7 dated July 5, 2020. By July 03, 2020, the trial had recruited a total of about 470 participants across 12 centers after approval from the National Bioethics Committee and Drug Regulatory Authority of Pakistan. Recruitment started on April 20, 2020. The recruitment is expected to continue for at least three months subject to review by the National Data Safety and Management Board (NDSMB) notified by Drug Regulatory Authority of Pakistan.
TRIAL REGISTRATION


Prospectively registered on 8 April 2020 at clinicaltrials.gov ID: NCT04338698 The full protocol is attached as an additional file, accessible from the Trials website (Additional file1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file2).",2020,Participants of any gender or age group having tested positive for COVID-19 on Real-Time qRT-PCR (Quantitative Reverse Transcription PCR) will be invited to take part in study at twelve centers across eight cities in Pakistan.,"['Those pregnant or lactating, severely dyspneic or with respiratory distress, already undergoing treatment, and with serious comorbidities like liver or kidney failure will be excluded', 'newly diagnosed patients with COVID-19 infection who have no comorbidities like diabetes mellitus', '8 April 2020 at clinicaltrials.gov ID', 'By July 03, 2020, the trial had recruited a total of about 470 participants across 12 centers after approval from the National Bioethics Committee and Drug Regulatory Authority of Pakistan', 'Eligible will be newly diagnosed patients, either hospitalized or in self-isolation, without any comorbidities or with controlled chronic medical conditions like diabetes mellitus and hypertension', 'Participants of any gender or age group having tested positive for COVID-19 on Real-Time qRT-PCR (Quantitative Reverse Transcription PCR) will be invited to take part in study at twelve centers across eight cities in Pakistan', 'Protocol Version 1.7 dated July 5, 2020']","['Hydroxychloroquine Phosphate/Sulfate', 'oseltamivir', 'Azithromycin', 'Hydroxychloroquine, Oseltamivir and Azithromycin', 'drug (Hydroxychloroquine Phosphate/Sulfate, Oseltamivir and Azithromycin']",['seven-category ordinal scale of clinical status on day 7 of follow-up'],"[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0005489', 'cui_str': 'Bioethics'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0035380', 'cui_str': 'Transcription, Reverse'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0011008', 'cui_str': 'Date'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0031603', 'cui_str': 'Phosphate'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.220653,Participants of any gender or age group having tested positive for COVID-19 on Real-Time qRT-PCR (Quantitative Reverse Transcription PCR) will be invited to take part in study at twelve centers across eight cities in Pakistan.,"[{'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Akram', 'Affiliation': 'Vice Chancellor/Professor of Internal Medicine, University of Health Sciences, Lahore, Pakistan.'}, {'ForeName': 'Shehnoor', 'Initials': 'S', 'LastName': 'Azhar', 'Affiliation': 'Assistant Professor Public Health, University of Health Sciences, Lahore, Pakistan. shehnoor.azhar@gmail.com.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Shahzad', 'Affiliation': 'Professor of Pharmacology, University of Health Sciences, Lahore, Pakistan.'}, {'ForeName': 'Waqas', 'Initials': 'W', 'LastName': 'Latif', 'Affiliation': 'Data Analyst at University of Health Sciences, Lahore, Pakistan.'}, {'ForeName': 'Khalid Saeed', 'Initials': 'KS', 'LastName': 'Khan', 'Affiliation': 'Distinguished Investigator at Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain.'}]",Trials,['10.1186/s13063-020-04616-4']
1842,32771034,"Nigella sativa supplementation to treat symptomatic mild COVID-19: A structured summary of a protocol for a randomised, controlled, clinical trial.","OBJECTIVES


To investigate the potential efficacy of Nigella sativa (NS) oil supplementation on the outcomes of patients with mild Coronavirus Disease 2019 (COVID-19).
TRIAL DESIGN


Prospective, two-arm, parallel-group, randomised (1:1 allocation ratio), open-label, controlled, exploratory phase II clinical trial of oral NS oil in patients with mild COVID-19.
PARTICIPANTS


Inclusion Criteria: - Patients with mild COVID19 (defined as upper respiratory tract infection symptoms in the absence of clinical or radiological signs of pneumonia). - Adult (18 - 65 years old). - Written informed consent by the patient (or legally authorized representative) prior to initiation of any study procedures. - All patients should understand and agree to comply with planned study procedures. - Polymerase chain reaction (PCR)-confirmed infection with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) from throat swab.
EXCLUSION CRITERIA


- Patients with pneumonia or severe illness requiring admission to intensive care unit. - Severe chronic kidney disease (i.e. estimated glomerular filtration rate [eGFR] < 30 mL / min ) or end stage renal disease requiring dialysis - Severe chronic liver disease (Alanine transaminase [AlT] or Aspartate transaminase [AST] > 5 times the upper limit of normal). - Pregnancy or breast feeding. - Anticipated transfer within 72 hours to another hospital that is not a study site. - Allergy to the study medication The trial is currently conducted on patients recruited from King Abdulaziz University Hospital, Jeddah, Saudi Arabia.
INTERVENTION AND COMPARATOR


Intervention group: Nigella sativa oil (MARNYS® Cuminmar) 500 mg softgel capsules, one capsule orally twice daily for 10 days plus standard of care treatment (antipyretic, antitussive). Comparator group: standard of care treatment.
MAIN OUTCOMES


Proportion of patients who clinically recovered (defined as 3 days of no symptoms) within 14 days after randomisation.
RANDOMISATION


Patients will be randomly assigned to treatment or control groups in a 1:1 ratio using a computer-generated randomization scheme (Random permuted blocks of 10) developed using the web-based program: http://www.randomization.com .
BLINDING (MASKING)


No blinding.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


Up to 200 eligible patients will be randomly assigned to either treatment or control groups.
TRIAL STATUS


Protocol version 1, as of July 14, 2020. Recruitment was started on May 21, 2020. The intended completion date is December 31, 2020.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04401202 . Date of trial registration: May 26, 2020.
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.",2020,"No blinding.
","['Inclusion Criteria: - Patients with mild COVID19 (defined as upper respiratory tract infection symptoms in the absence of clinical or radiological signs of pneumonia', 'patients recruited from King Abdulaziz University Hospital, Jeddah, Saudi Arabia', 'stage renal disease requiring dialysis - Severe chronic liver disease', ' Patients with pneumonia or severe illness requiring admission to intensive care unit', 'Protocol version 1, as of July 14, 2020', 'patients with mild COVID-19', '200 eligible patients', ' Adult (18 - 65 years old', 'patients with mild Coronavirus Disease 2019 (COVID-19']","['Nigella sativa supplementation', 'Nigella sativa oil (MARNYS® Cuminmar) 500 mg softgel capsules, one capsule orally twice daily for 10 days plus standard of care treatment (antipyretic, antitussive', 'computer-generated randomization scheme (Random permuted blocks of 10) developed using the web-based program: http://www.randomization.com ', 'Nigella sativa (NS) oil supplementation', 'care treatment', 'oral NS oil']","[' Severe chronic kidney disease', 'Alanine transaminase [AlT] or Aspartate transaminase [AST']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0036243', 'cui_str': 'Saudi Arabia'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3651714', 'cui_str': 'NIGELLA SATIVA SEED OIL'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003419', 'cui_str': 'Antipyretic Agents'}, {'cui': 'C0003449', 'cui_str': 'Antitussive agent'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028908', 'cui_str': 'Oil'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}]",,0.227921,"No blinding.
","[{'ForeName': 'Abdulrahman E', 'Initials': 'AE', 'LastName': 'Koshak', 'Affiliation': 'Department of Natural Products and Alternative Medicine, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia. aekoshak@kau.edu.sa.'}, {'ForeName': 'Emad A', 'Initials': 'EA', 'LastName': 'Koshak', 'Affiliation': 'Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Abdullah F', 'Initials': 'AF', 'LastName': 'Mobeireek', 'Affiliation': 'Department of Medicine, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mazen A', 'Initials': 'MA', 'LastName': 'Badawi', 'Affiliation': 'Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Siraj O', 'Initials': 'SO', 'LastName': 'Wali', 'Affiliation': 'Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Husam M', 'Initials': 'HM', 'LastName': 'Malibary', 'Affiliation': 'Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Ali F', 'Initials': 'AF', 'LastName': 'Atwah', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, King Abdulaziz University, Rabigh, Saudi Arabia.'}, {'ForeName': 'Meshari M', 'Initials': 'MM', 'LastName': 'Alhamdan', 'Affiliation': 'University Medical Services Centre, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Reem A', 'Initials': 'RA', 'LastName': 'Almalki', 'Affiliation': 'Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Tariq A', 'Initials': 'TA', 'LastName': 'Madani', 'Affiliation': 'Department of Medicine, Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.'}]",Trials,['10.1186/s13063-020-04647-x']
1843,32771068,Testing an early online intervention for the treatment of disturbed sleep during the COVID-19 pandemic (Sleep COVID-19): structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES


The primary aim of the present study is to examine the efficacy of an online intervention for poor sleep in the context of an ongoing stressful major life event, by assessing if this intervention can reduce insomnia severity at short-term (one week post-intervention) and long-term (one and three months post-intervention) follow-up time points. It is hypothesised that the intervention will: 1) reduce insomnia severity in poor sleepers, compared to wait-list control poor sleepers, and good sleepers; 2) reduce subjective symptoms of anxiety and depression in all groups, and 3) prevent the transition to acute insomnia in good sleepers.
TRIAL DESIGN


This study is a cluster randomised controlled trial.
PARTICIPANTS


Both healthy good sleepers, who do not report having any current sleep problems, and individuals who report having sleep problems, will be recruited for the present study. This is a single-site study (Northumbria University). This study will be delivered using the internet and there are no geographic restrictions. Individuals who self-report as poor sleepers will meet DSM-5 criteria for acute insomnia, which is where individuals: 1) have difficulties in falling asleep, staying asleep, or awakening too early for at least three nights per week, for a time period of between two weeks and three months; and 2) report experiencing distress or impairment caused by sleep loss. Both 1) and 2) must have occurred despite the individual having had an adequate opportunity for sleep during this time period. Good sleepers will be individuals who do not have current sleep problems. All participants must have a sufficient level of English comprehension to understand and complete study measures. Individuals cannot participate if they report having chronic sleep problems (where they have existed for more than three months immediately prior to providing consent), nor will individuals who are actively seeking treatment for their sleep problems irrespective of how long they have had the sleep problem. Individuals also cannot participate if they have a self-reported history of head injuries, or if they have a self-reported diagnosis of schizophrenia, epilepsy or personality disorder, as the distraction techniques involved in the insomnia intervention may increase rumination in individuals with these conditions, and influence the effectiveness of the intervention.
INTERVENTION AND COMPARATOR


Participants who receive the intervention will be provided with an online version of a self-help leaflet. A printed version of this leaflet has been successfully used in previous treatment studies, which have been conducted by our research group. Participants will be encouraged to download, save or print out this leaflet, which will be provided in PDF format. There will be no restrictions on use and participants will be encouraged to refer to this leaflet as often as they wish to. Briefly, this self-help leaflet aims to improve sleep by identifying and addressing sleep-related dysfunctional thinking by providing education about sleep, providing techniques to distract from intrusive worrisome thoughts at night, and providing guidelines for sleep-related stimulus control. The comparator is a wait-list control (i.e. where they will receive the intervention after a one month delay) group.
MAIN OUTCOMES


The primary outcome measure will be insomnia severity, as measured using the Insomnia Severity Index (Bastien, Vallières, & Morin, 2001), assessed immediately prior to the intervention and at one week, one month and three months post-intervention, compared to baseline. Secondary outcome measures will include subjective mood, measured using the 7-item Generalised Anxiety Disorder Questionnaire (GAD-7; Spitzer, Kroenke, Williams, & Lowe, 2006)) and 9-item Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001), assessed immediately prior to the intervention, and one week, one month and three months post-intervention, compared to baseline. Additionally, subjective sleep continuity, derived from sleep diaries (Carney et al., 2012), will be compared pre and post-intervention.
RANDOMISATION


This study will operate as a cluster randomised controlled trial. Good sleepers will be randomised into an intervention or a no-intervention group, with a 1:1 allocation. Poor sleepers will be randomised into an intervention or wait-list control group, with a 1:1 allocation. Randomisation will be conducted automatically using Qualtrics study software, where block sizes will be equal and randomisation will be computer-generated.
BLINDING (MASKING)


Participants will not be blinded to group assignment. The outcomes will be assessed by a blinded investigator.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The minimum sample size is 60. A total of 30 poor sleepers will be randomised to the intervention or wait-list control group. A total of 30 good sleepers will be randomised to the intervention or no intervention group.
TRIAL STATUS


Recruitment for this study has yet to start. It is anticipated that recruitment will begin in August 2020 and end in April 2022. The current study protocol is version 1.0 (20 July 2020) TRIAL REGISTRATION: This study was prospectively registered in the ISRCTN registry (registration number ISRCTN43900695 , date of registration: 8 April 2020).
FULL PROTOCOL


The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"It is hypothesised that the intervention will: 1) reduce insomnia severity in poor sleepers, compared to wait-list control poor sleepers, and good sleepers; 2) reduce subjective symptoms of anxiety and depression in all groups, and 3) prevent the transition to acute insomnia in good sleepers.
","['disturbed sleep during the COVID-19 pandemic (Sleep COVID-19', 'Both healthy good sleepers, who do not report having any current sleep problems, and individuals who report having sleep problems, will be recruited for the present study', 'A total of 30 poor sleepers']",['online intervention'],"['insomnia severity, as measured using the Insomnia Severity Index (Bastien, Vallières, & Morin, 2001), assessed immediately prior to the intervention', 'insomnia severity', 'subjective sleep continuity', 'subjective mood, measured using the 7-item Generalised Anxiety Disorder Questionnaire (GAD-7; Spitzer, Kroenke, Williams, & Lowe, 2006)) and 9-item Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001), assessed immediately prior to the intervention']","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0066801', 'cui_str': 'morin'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0456391', 'cui_str': 'Continuities'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]",,0.108244,"It is hypothesised that the intervention will: 1) reduce insomnia severity in poor sleepers, compared to wait-list control poor sleepers, and good sleepers; 2) reduce subjective symptoms of anxiety and depression in all groups, and 3) prevent the transition to acute insomnia in good sleepers.
","[{'ForeName': 'Greg J', 'Initials': 'GJ', 'LastName': 'Elder', 'Affiliation': 'Northumbria Sleep Research, Northumbria University, Newcastle upon Tyne, UK. g.elder@northumbria.ac.uk.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Alfonso-Miller', 'Affiliation': 'Northumbria Sleep Research, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'William C M', 'Initials': 'WCM', 'LastName': 'Atkinson', 'Affiliation': 'Northumbria Sleep Research, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nayantara', 'Initials': 'N', 'LastName': 'Santhi', 'Affiliation': 'Northumbria Sleep Research, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Ellis', 'Affiliation': 'Northumbria Sleep Research, Northumbria University, Newcastle upon Tyne, UK.'}]",Trials,['10.1186/s13063-020-04644-0']
1844,32761160,Effects of Candesartan vs Lisinopril on Neurocognitive Function in Older Adults With Executive Mild Cognitive Impairment: A Randomized Clinical Trial.,"Importance


Observational studies have suggested that angiotensin receptor blockers are associated with a unique cognitive protection. It is unclear if this is due to reduced blood pressure (BP) or angiotensin receptors type 1 blockade.
Objective


To determine neurocognitive effects of candesartan vs lisinopril in older adults with mild cognitive impairment (MCI).
Design, Setting, and Participants


This randomized clinical trial included participants aged 55 years or older with MCI and hypertension. Individuals were withdrawn from prior antihypertensive therapy and randomized in a 1 to 1 ratio to candesartan or lisinopril from June 2014 to December 2018. Participants underwent cognitive assessments at baseline and at 6 and 12 months. Brain magnetic resonance images were obtained at baseline and 12 months. This intent-to-treat study was double-blind and powered for a sample size accounting for 20% dropout. Data were analyzed from May to October 2019.
Interventions


Escalating doses of oral candesartan (up to 32 mg) or lisinopril (up to 40 mg) once daily. Open-label antihypertensive drug treatments were added as needed to achieve BP less than 140/90 mm Hg.
Main Outcomes and Measures


The primary outcome was executive function (measured using the Trail Making Test, Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research tool) and secondary outcomes were episodic memory (measured using the Hopkins Verbal Learning Test-Revised) and microvascular brain injury reflected by magnetic resonance images of white matter lesions.
Results


Among 176 randomized participants (mean [SD] age, 66.0 [7.8] years; 101 [57.4%] women; 113 [64.2%] African American), 87 were assigned to candesartan and 89 were assigned to lisinopril. Among these, 141 participants completed the trial, including 77 in the candesartan group and 64 in the lisinopril group. Although the lisinopril vs candesartan groups achieved similar BP (12-month mean [SD] systolic BP: 130 [17] mm Hg vs 134 [20] mm Hg; P = .20; 12-month mean [SD] diastolic BP: 77 [10] mm Hg vs 78 [11] mm Hg; P = .52), candesartan was superior to lisinopril on the primary outcome of executive function measured by Trail Making Test Part B (effect size [ES] = -12.8 [95% CI, -22.5 to -3.1]) but not Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research score (ES = -0.03 [95% CI, -0.08 to 0.03]). Candesartan was also superior to lisinopril on the secondary outcome of Hopkins Verbal Learning Test-Revised delayed recall (ES = 0.4 [95% CI, 0.02 to 0.8]) and retention (ES = 5.1 [95% CI, 0.7 to 9.5]).
Conclusions and Relevance


These findings suggest that in older adults with MCI, 1-year treatment with candesartan had superior neurocognitive outcomes compared with lisinopril. These effects are likely independent of the BP-lowering effect of candesartan.
Trial Registration


ClinicalTrials.gov Identifier: NCT01984164.",2020,", candesartan was superior to lisinopril on the primary outcome of executive function measured by Trail Making Test Part B (effect size [ES] = -12.8","['older adults with MCI', 'participants aged 55 years or older with MCI and hypertension', '176 randomized participants (mean [SD] age', '141 participants completed the trial, including 77 in the candesartan group and 64 in the lisinopril group', 'Hg vs 134 [20', 'Older Adults With Executive Mild Cognitive Impairment', 'older adults with mild cognitive impairment (MCI', '66.0 [7.8] years; 101 [57.4%] women; 113 [64.2%] African American']","['lisinopril vs candesartan', 'oral candesartan', 'Candesartan', 'candesartan or lisinopril', 'angiotensin receptor blockers', 'Candesartan vs Lisinopril', 'candesartan', 'candesartan vs lisinopril', 'lisinopril']","['SD] diastolic BP', 'Neurocognitive Function', 'executive function (measured using the Trail Making Test, Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research tool) and secondary outcomes were episodic memory (measured using the Hopkins Verbal Learning Test-Revised) and microvascular brain injury reflected by magnetic resonance images of white matter lesions', 'executive function measured by Trail Making Test Part B (effect size [ES', 'Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research score', 'Hopkins Verbal Learning Test-Revised delayed recall', 'blood pressure (BP', 'superior neurocognitive outcomes']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0717550', 'cui_str': 'candesartan'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C0065374', 'cui_str': 'Lisinopril'}, {'cui': 'C0717550', 'cui_str': 'candesartan'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C2752009', 'cui_str': 'White matter lesion'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1282910', 'cui_str': 'Upper'}]",176.0,0.234526,", candesartan was superior to lisinopril on the primary outcome of executive function measured by Trail Making Test Part B (effect size [ES] = -12.8","[{'ForeName': 'Ihab', 'Initials': 'I', 'LastName': 'Hajjar', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Okafor', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'McDaniel', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Malik', 'Initials': 'M', 'LastName': 'Obideen', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Dee', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Shokouhi', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Arshed A', 'Initials': 'AA', 'LastName': 'Quyyumi', 'Affiliation': 'Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Levey', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Goldstein', 'Affiliation': 'Department of Neurology, Emory University School of Medicine, Atlanta, Georgia.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.12252']
1845,32762109,Automated pulse wave velocity assessment using a professional oscillometric office blood pressure monitor.,"Carotid-femoral pulse wave velocity (cfPWV) is the gold standard method for assessing arterial stiffness. This study evaluated automated brachial-ankle PWV (baPWV) taken by a professional oscillometric blood pressure monitor (Microlife WatchBP Office Vascular) versus reference cfPWV (Complior device). Subjects recruited from a hypertension outpatient clinic had duplicate baPWV and cfPWV measurements (randomized crossover design) and carotid ultrasonography. Of 102 subjects recruited, 101 had valid baPWV measurements. Four subjects were excluded and 97 were analyzed (age 58.3 ± 11.4 years, men 70%, hypertensives 76%, diabetics 17%, cardiovascular disease 10%, smokers 23%). The mean difference between baPWV (13.1 ± 1.8 m/s) and cfPWV (9.1 ± 1.8 m/s) was 4.0 ± 1.4 m/s (P < .01) with close association between them (r = 0.70, P < .01). baPWV and cfPWV were correlated with age (r 0.54/0.49 respectively), systolic blood pressure (0.45/0.50), carotid intima-media thickness (0.31/0.44), and carotid distensibility coefficient (-0.47/-0.34) (all P < .05; no difference between the two methods, z test). There was reasonable agreement (77%) between the two methods in identifying subjects at the top quartile of their distributions (kappa 0.39, P < .01). The areas under the receiver operating characteristic curves for the identification of carotid plaques were comparable for cfPWV and baPWV (0.79 and 0.74 respectively, P = NS). Automated baPWV measurement by a professional oscillometric blood pressure monitor is feasible and observer-independent. baPWV values differ from those by cfPWV, yet they are closely correlated, have reasonable agreement in detecting increased arterial stiffness and give similar associations with carotid stiffness and atherosclerosis.",2020,"The areas under the receiver operating characteristic curves for the identification of carotid plaques were comparable for cfPWV and baPWV (0.79 and 0.74 respectively, P = NS).","['102 subjects recruited, 101 had valid baPWV measurements', 'Four subjects were excluded and 97 were analyzed (age 58.3\xa0±\xa011.4\xa0years, men 70%, hypertensives 76%, diabetics 17%, cardiovascular disease 10%, smokers 23', 'Subjects recruited from a hypertension outpatient clinic had duplicate baPWV and cfPWV measurements (randomized crossover design) and']","['carotid ultrasonography', 'Carotid-femoral pulse wave velocity (cfPWV', 'automated brachial-ankle PWV (baPWV) taken by a professional oscillometric blood pressure monitor (Microlife WatchBP Office Vascular) versus reference cfPWV (Complior device']","['cfPWV and baPWV', 'systolic blood pressure (0.45/0.50), carotid intima-media thickness', 'baPWV values', 'carotid distensibility coefficient', 'baPWV and cfPWV']","[{'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0005825', 'cui_str': 'Sphygmomanometers, Continuous'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",4.0,0.0770067,"The areas under the receiver operating characteristic curves for the identification of carotid plaques were comparable for cfPWV and baPWV (0.79 and 0.74 respectively, P = NS).","[{'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Kollias', 'Affiliation': 'Hypertension Center STRIDE-7, National and Kapodistrian University of Athens , School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece.'}, {'ForeName': 'Konstantinos G', 'Initials': 'KG', 'LastName': 'Kyriakoulis', 'Affiliation': 'Hypertension Center STRIDE-7, National and Kapodistrian University of Athens , School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece.'}, {'ForeName': 'Areti', 'Initials': 'A', 'LastName': 'Gravvani', 'Affiliation': 'Hypertension Center STRIDE-7, National and Kapodistrian University of Athens , School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Anagnostopoulos', 'Affiliation': 'Hypertension Center STRIDE-7, National and Kapodistrian University of Athens , School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece.'}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Stergiou', 'Affiliation': 'Hypertension Center STRIDE-7, National and Kapodistrian University of Athens , School of Medicine, Third Department of Medicine, Sotiria Hospital, Athens, Greece.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13966']
1846,32759239,"Efficacy of biofeedback, repetitive transcranial magnetic stimulation and pelvic floor muscle training for female neurogenic bladder dysfunction after spinal cord injury: a study protocol for a randomised controlled trial.","INTRODUCTION


Neurogenic bladder dysfunction is prevalent in female patients with spinal cord injury (SCI), and previous guidelines have recommended pelvic floor muscle training (PFMT) for first-line conservative treatment. However, the actual regimen of PFMT varies widely and the single treatment does not satisfy the need of some patients. Therefore, this study aims to provide a detailed rationale and methodology for comparing the effectiveness of PFMT, biofeedback and repetitive transcranial magnetic stimulation (rTMS) as adjunct treatments for neurogenic bladder dysfunction.
METHODS AND ANALYSIS


This trial is a single-centre randomised controlled trial for female patients with urinary incontinence (UI) in phase of chronic SCI. Eligible participants will be randomised to one of four arms: (1) PFMT, (2) PFMT with biofeedback, (3) PFMT and rTMS and (4) PFMT with biofeedback and rTMS. There will be 44 participants in each arm and all the subjects will undergo 20 treatment sessions, five times a week for 4 weeks. The outcomes will be evaluated at 4 weeks, 3 months and 6 months after randomisation. The primary outcome is the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, and the secondary outcomes include bladder diary, pelvic floor muscle function and the International Spinal Cord Injury Quality of Life Basic Data Set.
ETHICS AND DISSEMINATION


The Clinical Research and Biomedical Ethics Committee of the West China Hospital, Sichuan University has approved this trial and the approval number is 2019-885. All participants will be provided written informed consent after verification of the eligibility criteria. The results of this study will be accessible in peer-reviewed publications and be presented at academic conferences.
TRIAL REGISTRATION NUMBER


Chinese Clinical Trial Registry (ChiCTR1900026126).",2020,"The primary outcome is the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, and the secondary outcomes include bladder diary, pelvic floor muscle function and the International Spinal Cord Injury Quality of Life Basic Data Set.
","['female patients with spinal cord injury (SCI', 'female neurogenic bladder dysfunction after spinal cord injury', 'female patients with urinary incontinence (UI) in phase of chronic SCI']","['biofeedback, repetitive transcranial magnetic stimulation and pelvic floor muscle training', 'PFMT, biofeedback and repetitive transcranial magnetic stimulation (rTMS', 'PFMT, (2) PFMT with biofeedback, (3) PFMT and rTMS and (4) PFMT with biofeedback and rTMS', 'PFMT']","['International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, and the secondary outcomes include bladder diary, pelvic floor muscle function and the International Spinal Cord Injury Quality of Life Basic Data Set']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0005697', 'cui_str': 'Neurogenic bladder'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]","[{'cui': 'C4544471', 'cui_str': 'International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}]",,0.208539,"The primary outcome is the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form, and the secondary outcomes include bladder diary, pelvic floor muscle function and the International Spinal Cord Injury Quality of Life Basic Data Set.
","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Chenying', 'Initials': 'C', 'LastName': 'Fu', 'Affiliation': 'State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xiong', 'Affiliation': 'Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Zejun', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': 'Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Chengqi', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wei', 'Affiliation': 'Department of Rehabilitation Medicine Center, West China Hospital, Sichuan University, Chengdu, Sichuan, PR China weiquan@scu.edu.cn.'}]",BMJ open,['10.1136/bmjopen-2019-034582']
1847,32762701,"High-flow nasal cannula oxygen therapy versus non-invasive ventilation for chronic obstructive pulmonary disease patients after extubation: a multicenter, randomized controlled trial.","BACKGROUND


High-flow nasal cannula (HFNC) oxygen therapy is being increasingly used to prevent post-extubation hypoxemic respiratory failure and reintubation. However, evidence to support the use of HFNC in chronic obstructive pulmonary disease (COPD) patients with hypercapnic respiratory failure after extubation is limited. This study was conducted to test if HFNC is non-inferior to non-invasive ventilation (NIV) in preventing post-extubation treatment failure in COPD patients previously intubated for hypercapnic respiratory failure.
METHODS


COPD patients with hypercapnic respiratory failure who were already receiving invasive ventilation were randomized to HFNC or NIV at extubation at two large tertiary academic teaching hospitals. The primary endpoint was treatment failure, defined as either resumption of invasive ventilation or switching to the other study treatment modality (NIV for patients in the NFNC group or vice versa).
RESULTS


Ninety-six patients were randomly assigned to the HFNC group or NIV group. After secondary exclusion, 44 patients in the HFNC group and 42 patients in the NIV group were included in the analysis. The treatment failure rate in the HFNC group was 22.7% and 28.6% in the NIV group-risk difference of - 5.8% (95% CI, - 23.8-12.4%, p = 0.535), which was significantly lower than the non-inferior margin of 9%. Analysis of the causes of treatment failure showed that treatment intolerance in the HFNC group was significantly lower than that in the NIV group, with a risk difference of - 50.0% (95% CI, - 74.6 to - 12.9%, p = 0.015). One hour after extubation, the mean respiratory rates of both groups were faster than their baseline levels before extubation (p < 0.050). Twenty-four hours after extubation, the respiratory rate of the HFNC group had returned to baseline, but the NIV group was still higher than the baseline. Forty-eight hours after extubation, the respiratory rates of both groups were not significantly different from the baseline. The average number of daily airway care interventions in the NIV group was 7 (5-9.3), which was significantly higher than 6 (4-7) times in the HFNC group (p = 0.006). The comfort score and incidence of nasal and facial skin breakdown of the HFNC group was also significantly better than that of the NIV group [7 (6-8) vs 5 (4-7), P < 0.001] and [0 vs 9.6%, p = 0.027], respectively.
CONCLUSION


Among COPD patients with severe hypercapnic respiratory failure who received invasive ventilation, the use of HFNC after extubation did not result in increased rates of treatment failure compared with NIV. HFNC also had better tolerance and comfort than NIV.
TRIAL REGISTRATION


chictr.org ( ChiCTR1800018530 ). Registered on 22 September 2018, http://www.chictr.org.cn/usercenter.aspx.",2020,"The treatment failure rate in the HFNC group was 22.7% and 28.6% in the NIV group-risk difference of - 5.8% (95% CI, - 23.8-12.4%, p = 0.535), which was significantly lower than the non-inferior margin of 9%.","['COPD patients previously intubated for hypercapnic respiratory failure', 'COPD patients with severe hypercapnic respiratory failure who received', 'Ninety-six patients', '44 patients in the HFNC group and 42 patients in the NIV group were included in the analysis', 'chronic obstructive pulmonary disease (COPD) patients with hypercapnic respiratory failure after extubation', 'COPD patients with hypercapnic respiratory failure who were already receiving invasive ventilation were randomized to HFNC or NIV at extubation at two large tertiary academic teaching hospitals', 'chronic obstructive pulmonary disease patients after extubation']","['High-flow nasal cannula ', 'invasive ventilation', 'HFNC) oxygen therapy', 'HFNC', 'High-flow nasal cannula oxygen therapy versus non-invasive ventilation']","['rates of treatment failure', 'treatment failure rate', 'respiratory rates', 'treatment failure, defined as either resumption of invasive ventilation or switching to the other study treatment modality (NIV', 'mean respiratory rates', 'comfort score and incidence of nasal and facial skin breakdown', 'respiratory rate', 'average number of daily airway care interventions']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0398353', 'cui_str': 'Hypercapnic respiratory failure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C4761117', 'cui_str': 'High-flow nasal cannula oxygen therapy'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]","[{'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C0699900', 'cui_str': 'Catabolism'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",96.0,0.196719,"The treatment failure rate in the HFNC group was 22.7% and 28.6% in the NIV group-risk difference of - 5.8% (95% CI, - 23.8-12.4%, p = 0.535), which was significantly lower than the non-inferior margin of 9%.","[{'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Tan', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Joseph Harold', 'Initials': 'JH', 'LastName': 'Walline', 'Affiliation': 'Accident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong, Prince of Wales Hospital, Hong Kong SAR, China.'}, {'ForeName': 'Bingyu', 'Initials': 'B', 'LastName': 'Ling', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Jiayan', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Pharmacy Department, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China. 32494845@qq.com.""}, {'ForeName': 'Bingxia', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Xueqin', 'Initials': 'X', 'LastName': 'Shan', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Yunyun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Cao', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Qingcheng', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Geng', 'Affiliation': ""Department of Emergency Medicine, Clinical Medical College of Yangzhou University, Northern Jiangsu People's Hospital, Yangzhou, 225001, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Emergency Department, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 100730, China. xujunfree@126.com.'}]","Critical care (London, England)",['10.1186/s13054-020-03214-9']
1848,32763585,Plasma MCP-1 levels in bipolar depression during cyclooxygenase-2 inhibitor combination treatment.,"BACKGROUND


Neuroinflammation plays a role in the pathophysiology of Bipolar Disorder Depression (BDD) and altered levels of inflammatory mediators, such as monocyte chemoattractant protein-1 (MCP-1, aka CCL2) have been reported. This study reports specifically on MCP-1 levels, as a potential marker of BDD and/or treatment response in patients receiving combination treatment with the cyclooxygenase-2 inhibitor, celecoxib (CBX).
METHODS


In this randomized, 10-week, double-blind, two-arm, placebo-controlled study, 47 patients with treatment resistant BDD received either escitalopram (ESC) + CBX, or ESC + placebo (PBO). Plasma MCP-1 levels were measured at 3 time points in the BDD subjects, and in a healthy control (HC) group. Depression severity was quantified using the Hamilton Depression Scale (HAMD-17).
RESULTS


The CBX group had significantly lower HAMD-17 scores vs. PBO at week 4 (P = 0.026) and week 8 (P = 0.002). MCP-1 levels were not significantly different in BDD vs. HC subjects at baseline (P = 0.588), nor in CBX vs. PBO groups at week 8 (P = 0.929). Week 8 HAMD-17 scores and MCP-1 levels were significantly negatively correlated in treatment non-responders to CBX or PBO (P = 0.050). Non-responders had significantly lower MCP-1 levels vs. responders at weeks 4 (P = 0.049) and 8 (P = 0.014). MCP-1 was positively correlated with pro-inflammatory analytes in the PBO group and with anti-inflammatory analytes in the CBX group.
CONCLUSIONS


Combination treatment reduced treatment resistance and augmented antidepressant response. Baseline plasma MCP-1 levels were not altered in BDD patients. Since non-responders had lower levels of MCP-1, elevated MCP-1 may indicate a better response to CBX + SSRI treatment.",2020,Non-responders had significantly lower MCP-1 levels vs. responders at weeks 4 (P = 0.049) and 8 (P = 0.014).,"['47 patients with treatment resistant BDD received either', 'patients receiving combination treatment with the']","['cyclooxygenase-2 inhibitor combination treatment', 'cyclooxygenase-2 inhibitor, celecoxib (CBX', 'CBX', 'escitalopram (ESC)\xa0+\xa0CBX, or ESC\xa0+\xa0placebo (PBO', 'placebo']","['Depression severity', 'Hamilton Depression Scale (HAMD-17', 'treatment resistance and augmented antidepressant response', 'MCP-1 levels', 'HAMD-17 scores and MCP-1 levels', 'MCP-1', 'Baseline plasma MCP-1 levels', 'Plasma MCP-1 levels', 'HAMD-17 scores vs. PBO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}]","[{'cui': 'C1257954', 'cui_str': 'Cyclooxygenase-2 inhibitor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",47.0,0.0285352,Non-responders had significantly lower MCP-1 levels vs. responders at weeks 4 (P = 0.049) and 8 (P = 0.014).,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Edberg', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Hoppensteadt', 'Affiliation': 'Department of Pathology, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Walborn', 'Affiliation': 'Department of Pathology, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Jawed', 'Initials': 'J', 'LastName': 'Fareed', 'Affiliation': 'Department of Pathology, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sinacore', 'Affiliation': 'Department of Public Health Sciences, Loyola University Stritch School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Angelos', 'Initials': 'A', 'LastName': 'Halaris', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, Loyola University Stritch School of Medicine, Chicago, IL, USA. Electronic address: ahalaris@lumc.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.06.010']
1849,32763623,Effect of exogenous progesterone administration on smoking topography.,"INTRODUCTION


Progesterone has been implicated as protective against drug taking behaviors, including combustible cigarettes. While prior research indicates higher endogenous progesterone levels are associated with a reduction in smoking intensity (as measured by smoking topography), it is unknown if exogenous delivery of progesterone may have the same effect.
METHODS


This double-blind, counterbalanced, cross-over randomized trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives. After overnight abstinence participants attended two topography lab sessions. One lab session was conducted during progesterone (200 mg twice per day) treatment and the other was during placebo treatment. Analyses included linear mixed effect models to examine the effect of exogenous progesterone administration and endogenous progesterone values on topography outcomes.
RESULTS


Participants (n = 43) were 23.8 (standard deviation [SD] ± 4.5) years old, smoked 10.5 (SD ± 3.7) cigarettes per day. Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL (95% confidence interval [CI]: -536, -65; p-value = 0.01) with additional trends indicating possible reductions in the number of puffs, average puff volume, and average flow. There were no significant effects of endogenous progesterone on smoking topography outcomes.
CONCLUSIONS


Progesterone administration has the potential to reduce smoking intensity after overnight abstinence in women of reproductive age. Additional research is needed to explore how this may relate to smoking cessation outcomes in women of reproductive age.",2020,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","['Participants (n\xa0=\xa043) were 23.8 (standard deviation [SD]\xa0±\xa04.5) years old, smoked 10.5 (SD\xa0±\xa03.7) cigarettes per day', 'trial enrolled women between the ages of 18 and 40 who smoked at least five cigarettes per day and were currently using oral contraceptives', 'women of reproductive age']","['progesterone', 'exogenous progesterone', 'Progesterone', 'placebo']","['cumulative puff volume', 'number of puffs, average puff volume, and average flow', 'smoking intensity', 'smoking topography']","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1527415', 'cui_str': 'Oral route'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}]","[{'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",43.0,0.178407,"Compared to placebo administration, progesterone administration reduced cumulative puff volume by 300 mL","[{'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Allen', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States. Electronic address: aliciaallen@arizona.edu.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Petersen', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Harrison', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Nair', 'Affiliation': 'Department of Family and Community Medicine, College of Medicine - Tucson, University of Arizona, United States.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Allen', 'Affiliation': 'Department of Family Medicine and Community Health, Medical School, University of Minnesota, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106570']
1850,32763625,Evaluation of impact-shock on gait after the implementation of two different training programs in older adults.,"BACKGROUND


Gait is negatively affected with increasing age. It is widely accepted that training produces physical-functional improvements in older adults, which can be assessed with numerous physical-functional tests. However, very few studies have been carried out using accelerometry to analyse the training effect on kinetic and kinematic variables in older adults, and there is no one that investigate the effects of two different training programs. Therefore, the aim of this study is to analyse the effects of an interval-walking program and a multicomponent program on the acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed in older adults.
METHODS


23 participants were divided into multicomponent training group [n = 12, 7 female, 71.58 (4.56) years] and interval-walking group [n = 11, 6 female, 69.64 (3.56) years]. We evaluated the participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead.
FINDINGS


After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group. The maximum acceleration values for the head and the stride frequency also increased in the interval-walking group. Lower limb strength improved in both groups.
INTERPRETATION


Given the benefits we found for each of these programs, we encourage their consideration when planning older adults training programs and suggest that multicomponent programs should be introduced prior to the start of walking-based programs.",2020,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","['participants using three triaxial accelerometers, placing one on the distal end of each tibia and one on the forehead', 'group [n\xa0=\xa012, 7 female, 71.58 (4.56) years] and interval-walking group [n\xa0=\xa011, 6 female, 69.64 (3.56) years', 'older adults', '23 participants']","['multicomponent training', 'interval-walking program and a multicomponent program']","['Lower limb strength', 'maximum acceleration values', 'stride frequency', 'acceleration impacts, shock attenuation, step-length, stride frequency, and gait speed']","[{'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0016540', 'cui_str': 'Forehead structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517763', 'cui_str': '4.56'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",23.0,0.0172172,"After 14 weeks' of training, the maximum acceleration values both for the head accelerometer and for the non-dominant tibia, as well as the attenuation in the same leg, increased in the multicomponent training group.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Sanchis-Sanchis', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Camacho-García', 'Affiliation': 'Departamento de Comunicaciones, Universitat Politècnica de València, Alcoy, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Encarnación-Martínez', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pérez-Soriano', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Department of Physical Education and Sports, University of Valencia, Valencia, Spain. Electronic address: pedro.perez-soriano@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105131']
1851,32768403,"Effects of Dexamethasone and Photobiomodulation on Pain, Swelling, and Quality of Life After Buccal Fat Pad Removal: A Clinical Trial.","PURPOSE


In this study we aimed to compare the effects of photobiomodulation (PBM) and dexamethasone (DXM) on pain, swelling, and the quality-of-life (QOL) of patients submitted to buccal fat pad removal.
PATIENTS AND METHODS


A total of 20 patients with pseudoherniation of buccal fat pad were included in the present study. The patients were divided randomly into 2 groups: the PBM group (660 nm, 100 mW, 6 seconds, 2 J/cm 2 ) and the DXM group (4 mg every 8 hours for 3 days after the procedure). Pain levels were evaluated using a visual analog scale at days 2 and 4 after surgery, whereas the edema was evaluated by measuring the distance between 6 reference points: tragus, pogonion of the soft tissue, lateral eye commissure, the gonial angle, nose wing, and mouth commissure at days 2, 4, 7, 15, 30, 60, and 90. The QOL was evaluated using the Oral Health Impact Profile 14 questionnaire at days 2 and 4 after surgery.
RESULTS


There were no differences between the PBM and DXM groups in pain or edema. In terms of the QOL, the PBM group was significantly more comfortable when chewing than the DXM group (P < .05) CONCLUSION: The use of PBM at a power of 100 mW and 2 J/cm 2  per point had similar effects to oral DXM for the control of pain and edema, as well as in the QOL, except for masticatory function, which was significantly better in the PBM group.",2020,There were no differences between the LLLT and DXM groups in pain or edema.,"['patients submitted to buccal fat pad removal', '20 patients with pseudoherniation of buccal fat pad were included in the present study']","['Dexamethasone and Low-Level Laser Therapy', 'LLLT', 'DXM group', 'DXM', 'LLLT and DXM', 'low-level laser therapy (LLLT) and dexamethasone (DXM', 'oral DXM', 'Buccal Fat Pad Removal']","['Pain, Swelling, and Quality of Life', 'pain, swelling, and the quality of life (QOL', 'Pain levels', 'pain and edema', 'pain or edema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226900', 'cui_str': 'Buccal fat pad'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0360528', 'cui_str': 'Dexamethasone-containing product in oral dose form'}, {'cui': 'C0226900', 'cui_str': 'Buccal fat pad'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",20.0,0.0567639,There were no differences between the LLLT and DXM groups in pain or edema.,"[{'ForeName': 'Diego Assunção', 'Initials': 'DA', 'LastName': 'Calixto Da Silva', 'Affiliation': 'Resident, Dental School, University Center of Pará, Belém, Pará, Brazil.'}, {'ForeName': 'Fabio De Lucas Da', 'Initials': 'FLD', 'LastName': 'Silva Almeida', 'Affiliation': 'Resident, Dental School, University Center of Pará, Belém, Pará, Brazil.'}, {'ForeName': 'Tamara Melo Nunes', 'Initials': 'TMN', 'LastName': 'Ota', 'Affiliation': 'Resident, Dental School, University Center of Pará, Belém, Pará, Brazil.'}, {'ForeName': 'Douglas Magno', 'Initials': 'DM', 'LastName': 'Guimaraes', 'Affiliation': 'Professor, Dental School, University Center of Pará, Belém, Pará, Brazil; Staff, EBSERH, Belém, Pará, Brazil; and Posgradute Student, Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University - UNINOVE, São Paulo, São Paulo, Brazil. Electronic address: Douglas_guima@hotmail.com.'}, {'ForeName': 'Kristianne Porta Santos', 'Initials': 'KPS', 'LastName': 'Fernandes', 'Affiliation': 'Department Head, Postgraduate Program in Biophotonics Applied to Health Sciences, Nove de Julho University - UNINOVE, São Paulo, São Paulo, Brazil.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.07.006']
1852,32768512,Abuse liability of cigarettes with very low nicotine content in pregnant cigarette smokers.,"The U.S. Food and Drug Administration has proposed reducing the nicotine content of cigarettes to a minimally-addictive level. To our knowledge, this study is the first to examine how pregnant smokers respond to very low nicotine content (VLNC) cigarettes. In Phase 1, participants blindly sampled two VLNC cigarettes (0.4 and 2.4 mg/g of tobacco) and their usual brand (UB) cigarette in separate sessions, then completed a behavioral economic simulation task and measures of subjective effects, craving/withdrawal, and smoking topography. Phase 2 directly compared the relative reinforcing effects of the cigarettes using concurrent choice testing. All possible dose-pair combinations were tested in separate sessions where puffs were earned ad libitum by clicking the code associated with their preferred cigarette 10 times. Phase 3 tested the 0.4 mg/g-UB dose-pair where UB puffs could be earned with a progressively incremented number of clicks (maximum 8400). Ten pregnant smokers in Burlington, VT and Baltimore, MD participated in 2017-2018. Regarding abuse liability, participants chose the 0.4-mg/g dose less than UB (22% vs. 78%) during concurrent choice testing and the 0.4-mg/g dose sustained less demand than the 2.4-mg/g and UB doses on the simulation task. Positive subjective effects were also lower for both VLNC cigarettes vs. UB. Each cigarette reduced nicotine craving/withdrawal and no significant changes indicative of compensatory smoking were noted. Reducing the nicotine content of cigarettes may decrease their abuse liability in pregnant smokers without causing untoward craving/withdrawal or compensatory smoking. Studies of extended exposure to VLNCs in pregnant women are warranted.",2020,Reducing the nicotine content of cigarettes may decrease their abuse liability in pregnant smokers without causing untoward craving/withdrawal or compensatory smoking.,"['Pregnant Cigarette Smokers', 'Ten pregnant smokers in Burlington, VT and Baltimore, MD participated in 2017-2018', 'pregnant smokers respond to very low nicotine content (VLNC) cigarettes', 'pregnant smokers', 'pregnant women']",[],"['compensatory smoking', 'abuse liability', 'Positive subjective effects']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]",[],"[{'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",10.0,0.0143412,Reducing the nicotine content of cigarettes may decrease their abuse liability in pregnant smokers without causing untoward craving/withdrawal or compensatory smoking.,"[{'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Heil', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, UHC MS #482, 1 South Prospect St., Burlington, VT 05401, United States of America. Electronic address: sarah.heil@uvm.edu.'}, {'ForeName': 'Cecilia L', 'Initials': 'CL', 'LastName': 'Bergeria', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, UHC MS #482, 1 South Prospect St., Burlington, VT 05401, United States of America. Electronic address: cecilia.bergeria@uvm.edu.'}, {'ForeName': 'Dustin C', 'Initials': 'DC', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, 5510 Nathan Shock Drive, Baltimore, MD 21224-6823, United States of America. Electronic address: dlee214@jhmi.edu.'}, {'ForeName': 'Janice Y', 'Initials': 'JY', 'LastName': 'Bunn', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, UHC MS #482, 1 South Prospect St., Burlington, VT 05401, United States of America. Electronic address: janice.bunn@uvm.edu.'}, {'ForeName': 'Roxanne F', 'Initials': 'RF', 'LastName': 'Harfmann', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, UHC MS #482, 1 South Prospect St., Burlington, VT 05401, United States of America. Electronic address: roxanne.harfmann@uvm.edu.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hughes', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, UHC MS #482, 1 South Prospect St., Burlington, VT 05401, United States of America. Electronic address: john.hughes@med.uvm.edu.'}, {'ForeName': 'Haley J', 'Initials': 'HJ', 'LastName': 'Tetreault', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, UHC MS #482, 1 South Prospect St., Burlington, VT 05401, United States of America. Electronic address: haley.tetreault@uvm.edu.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'Vermont Center on Behavior and Health, University of Vermont, UHC MS #482, 1 South Prospect St., Burlington, VT 05401, United States of America. Electronic address: stephen.higgins@uvm.edu.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106227']
1853,32769633,Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix.,"OBJECTIVE


To evaluate the effects of elagolix on clinically meaningful improvements in health-related quality of life (HRQOL) measured by the EHP-30 (Endometriosis Health Profile-30).
METHODS


Data from two phase III trials of elagolix for moderate to severe pain associated with endometriosis were pooled and analyzed as three groups: placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily. Patients were administered the EHP-30 questionnaire at baseline, and at months 1, 3, and 6 of treatment. Previously established responder definitions were applied to determine percentages of patients with clinically meaningful EHP-30 improvements. The probability of meeting EHP-30 responder definitions with elagolix compared with placebo at months 3 and 6 was determined by Poisson regression analysis, controlling for baseline scores.
RESULTS


At month 6, the probabilities of meeting EHP-30 subscale responder definitions for pain, control and powerlessness, self-image, social support, emotional well-being, and sexual intercourse were 169% (adjusted relative risk [aRR]: 2.69, 95% CI 2.26-3.21), 129% (aRR 2.29, 95% CI 1.96-2.67), 80% (aRR 1.80, 95% CI 1.54-2.11), 70% (aRR 1.70, 95% CI 1.47-1.97), 67% (aRR 1.67, 95% CI 1.45-1.92), and 62% (aRR 1.62, 95% CI 1.36-1.92) greater, respectively (all P<.001), in the 200-mg group than in the placebo group. Although lower in magnitude than the 200-mg group, the 150-mg group also had greater probabilities of meeting responder definitions than the placebo group for all subscales except sexual intercourse. The probabilities of meeting responder definitions for pain, control and powerlessness, self-image, social support, and emotional well-being were 75% (aRR 1.75, 95% CI 1.44-2.14), 50% (aRR 1.50, 95% CI 1.25-1.80), 22% (aRR 1.22, 95% CI 1.01-1.47), 30% (aRR 1.30, 95% CI 1.09-1.53), and 35% (aRR 1.35, 95% CI 1.16-1.57) greater, respectively (all P<.05), in the 150-mg group than in the placebo group.
CONCLUSION


Patients with moderate to severe pain associated with endometriosis and were treated with elagolix experienced clinically meaningful HRQOL improvements.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT01620528 and NCT01931670.
FUNDING SOURCE


AbbVie Inc.",2020,"At month 6, the probabilities of meeting EHP-30 subscale responder definitions for pain, control and powerlessness, self-image, social support, emotional well-being, and sexual intercourse were 169% (adjusted relative risk [aRR]: 2.69, 95% CI 2.26-3.21), 129% (aRR 2.29, 95% CI 1.96-2.67), 80% (aRR 1.80, 95% CI 1.54-2.11), 70% (aRR 1.70, 95% CI 1.47-1.97), 67% (aRR 1.67, 95% CI 1.45-1.92), and 62% (aRR 1.62, 95% CI 1.36-1.92) greater, respectively (all P<.001), in the 200-mg group than in the placebo group.","['Patients', 'Data from two phase III trials of elagolix for moderate to severe pain associated with endometriosis']","['elagolix', 'Elagolix', 'placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily', 'placebo']","['health-related quality of life (HRQOL', 'Health-Related Quality of Life Improvements', 'probabilities of meeting responder definitions for pain, control and powerlessness, self-image, social support, and emotional well-being', 'probabilities of meeting EHP-30 subscale responder definitions for pain, control and powerlessness, self-image, social support, emotional well-being, and sexual intercourse', 'probabilities of meeting responder definitions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C2714632', 'cui_str': 'elagolix'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]","[{'cui': 'C2714632', 'cui_str': 'elagolix'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4704593', 'cui_str': 'elagolix 150 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4704604', 'cui_str': 'elagolix 200 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150063', 'cui_str': 'Feeling powerless'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",,0.419231,"At month 6, the probabilities of meeting EHP-30 subscale responder definitions for pain, control and powerlessness, self-image, social support, emotional well-being, and sexual intercourse were 169% (adjusted relative risk [aRR]: 2.69, 95% CI 2.26-3.21), 129% (aRR 2.29, 95% CI 1.96-2.67), 80% (aRR 1.80, 95% CI 1.54-2.11), 70% (aRR 1.70, 95% CI 1.47-1.97), 67% (aRR 1.67, 95% CI 1.45-1.92), and 62% (aRR 1.62, 95% CI 1.36-1.92) greater, respectively (all P<.001), in the 200-mg group than in the placebo group.","[{'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Taylor', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut; AbbVie Inc., North Chicago, Illinois; and Evidera, Bethesda, Maryland.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Soliman', 'Affiliation': ''}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Johns', 'Affiliation': ''}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Pokrzywinski', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Snabes', 'Affiliation': ''}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Coyne', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003917']
1854,32769639,Reducing the Risk for Postpartum Depression in Adolescent Mothers: A Randomized Controlled Trial.,"OBJECTIVE


To estimate the effect of an interpersonal therapy-based intervention on reducing the risk of postpartum depression in adolescents.
METHODS


A randomized controlled trial enrolled 250 pregnant adolescents who were aged 18 years or younger at conception. The initial sample size calculation estimated 276 participants (324 with attrition) were needed to detect a 50% reduction in risk of the primary outcome, postpartum major depressive episode, with an alpha of 0.05% and 80% power. An interim analysis by the Data Safety and Monitoring Committee informed a revision in the sample size target to 250. Participants were randomized to the intervention (n=129) or a time-matched control group (n=121) who attended sessions about pregnancy topics. Each group received five prenatal sessions and a postpartum booster session. A structured diagnostic interview was administered at baseline and specific time points through 12-months postpartum to assess for major depressive episode onset.
RESULTS


Participants were recruited from December 2011 to May 2016 through urban prenatal care sites in the state of Rhode Island. Of the 250 participants, 58% identified as Hispanic and 20% as black or African American. The rate of major depressive episode by 12 months postpartum was 7.0% (95% CI 2.3-11.7%) in the control group and 7.6% (95% CI 2.5-12.7%) in the intervention group, with no significant difference between groups at any time point (P=.88 by log-rank test).
CONCLUSION


No benefit was shown between the intervention and control groups in the rates of major depressive episode, which is likely related to a lower than predicted rate of this outcome in the control group (7.6% actual vs 25% predicted). Enhanced local community resources available to pregnant and parenting adolescents during the study period may be an explanation for this result.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT01482832.",2020,"No benefit was shown between the intervention and control groups in the rates of major depressive episode, which is likely related to a lower than predicted rate of this outcome in the control group (7.6% actual vs 25% predicted).","['250 pregnant adolescents who were aged 18 years or younger at conception', 'Participants were recruited from December 2011 to May 2016 through urban prenatal care sites in the state of Rhode Island', '276 participants (324 with attrition', 'pregnant and parenting adolescents', 'Adolescent Mothers', 'adolescents', '250 participants, 58% identified as Hispanic and 20% as black or African American']","['time-matched control group (n=121) who attended sessions about pregnancy topics', 'interpersonal therapy-based intervention', 'five prenatal sessions and a postpartum booster session']","['rate of major depressive episode', 'rates of major depressive episode']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0035487', 'cui_str': 'Rhode Island'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}]","[{'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}]",250.0,0.208404,"No benefit was shown between the intervention and control groups in the rates of major depressive episode, which is likely related to a lower than predicted rate of this outcome in the control group (7.6% actual vs 25% predicted).","[{'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Phipps', 'Affiliation': 'Departments of Obstetrics and Gynecology and Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, the Department of Epidemiology, Brown University School of Public Health, the Department of Obstetrics and Gynecology, Women & Infants Hospital of Rhode Island, and the Women & Infants Hospital of Rhode Island, Providence, Rhode Island; the University of Cape Town, Cape Town, South Africa, and the Pacific Institute for Research and Evaluation, Beltsville, Maryland.'}, {'ForeName': 'Crystal F', 'Initials': 'CF', 'LastName': 'Ware', 'Affiliation': ''}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Stout', 'Affiliation': ''}, {'ForeName': 'Christina A', 'Initials': 'CA', 'LastName': 'Raker', 'Affiliation': ''}, {'ForeName': 'Caron', 'Initials': 'C', 'LastName': 'Zlotnick', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004003']
1855,32769877,Protective effect of probiotics in patients with non-alcoholic fatty liver disease.,"To investigate the effects of probiotics on liver function, glucose and lipids metabolism, and hepatic fatty deposition in patients with non-alcoholic fatty liver disease (NAFLD).Totally 140 NAFLD cases diagnosed in our hospital from March 2017 to March 2019 were randomly divided into the observation group and control group, 70 cases in each. The control group received the diet and exercise therapy, while the observation group received oral probiotics based on the control group, and the intervention in 2 groups lasted for 3 months. The indexes of liver function, glucose and lipids metabolism, NAFLD activity score (NAS), and conditions of fecal flora in 2 groups were compared before and after the treatment.Before the treatment, there were no significant differences on alanine aminotransferase (ALT), aspartate aminotransferase (AST), glutamine transferase (GGT), total bilirubin (TBIL), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), insulin resistance index (HOMA-IR), NAFLD activity score (NAS), and conditions of fecal flora in 2 groups (P > .05). After the treatment, ALT, AST, GGT, TC, TG, HOMA-IR, NAS, and conditions of fecal flora in the observation group were better than those in the control group, and the observation group was better after treatment than before. All these above differences were statistically significant (P < .05).Probiotics can improve some liver functions, glucose and lipids metabolism, hepatic fatty deposition in patients with NAFLD, which will enhance the therapeutic effects of NAFLD.",2020,"All these above differences were statistically significant (P < .05).Probiotics can improve some liver functions, glucose and lipids metabolism, hepatic fatty deposition in patients with NAFLD, which will enhance the therapeutic effects of NAFLD.","['patients with NAFLD', 'patients with non-alcoholic fatty liver disease (NAFLD).Totally 140 NAFLD cases diagnosed in our hospital from March 2017 to March 2019', 'patients with non-alcoholic fatty liver disease']","['diet and exercise therapy, while the observation group received oral probiotics', 'probiotics']","['ALT, AST, GGT, TC, TG, HOMA-IR, NAS, and conditions of fecal flora', 'liver functions, glucose and lipids metabolism, hepatic fatty deposition', 'liver function, glucose and lipids metabolism, and hepatic fatty deposition', 'indexes of liver function, glucose and lipids metabolism, NAFLD activity score (NAS), and conditions of fecal flora', 'alanine aminotransferase (ALT), aspartate aminotransferase (AST), glutamine transferase (GGT), total bilirubin (TBIL), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), insulin resistance index (HOMA-IR), NAFLD activity score (NAS), and conditions of fecal flora']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0333574', 'cui_str': 'Fatty deposition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0061485', 'cui_str': 'Glutamine phenylacetyltransferase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}]",,0.0164329,"All these above differences were statistically significant (P < .05).Probiotics can improve some liver functions, glucose and lipids metabolism, hepatic fatty deposition in patients with NAFLD, which will enhance the therapeutic effects of NAFLD.","[{'ForeName': 'Gen-Shen', 'Initials': 'GS', 'LastName': 'Cai', 'Affiliation': 'Department of General Medicine.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Department of Gastroenterology, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of General Medicine.'}]",Medicine,['10.1097/MD.0000000000021464']
1856,32769878,A phase 3 double-blind randomized (CONSORT-compliant) study of azilsartan medoxomil compared to valsartan in Chinese patients with essential hypertension.,"BACKGROUND


Azilsartan medoxomil (AZL-M), an angiotensin II receptor blocker, has a well-characterized efficacy and safety profile in patients with hypertension. AZL-M is approved for use in over 40 countries globally; however, it is not yet approved in China. Therefore, a phase 3 registration study to assess the efficacy (antihypertensive effect), safety, and tolerability of AZL-M compared with valsartan in Chinese patients with essential hypertension was undertaken.
METHODS


This multicenter, double-blind, randomized, 8-week phase 3 study compared AZL-M with valsartan in Chinese patients aged ≥18 years with essential hypertension. Endpoints included change from baseline to week 8 in trough sitting clinic systolic blood pressure (scSBP) and ambulatory blood pressure monitoring parameters.
RESULTS


Overall, 612 patients (mean age, 57.1 years; 57.5% male) were randomized to AZL-M 80 mg (n = 209), AZL-M 40 mg (n = 199), or valsartan 160 mg (n = 204). Baseline mean scSBP was similar in all groups (157.9-158.5 mm Hg). The mean reduction in trough scSBP from baseline to week 8 was significantly greater with AZL-M 80 mg than with valsartan (-24.2 vs -20.6 mm Hg; P = .010), and noninferior with AZL-M 40 mg versus valsartan (-22.5 vs -20.6 mm Hg; P = .184). Mean reduction in 24-hour mean systolic blood pressure (n = 257) was significantly greater with both AZL-M 80 mg (-17.0 mm Hg; P < .001) and AZL-M 40 mg (-14.7 mm Hg; P = .014) than with valsartan (-9.4 mm Hg). Treatment-emergent adverse events had similar incidence (52.8%-56.5%) across the treatment groups and were generally mild or moderate. Dizziness was the most frequent treatment-related treatment-emergent adverse events (AZL-M 80 mg, 1.9%; AZL-M 40 mg, 1.5%; valsartan, 1.0%). The safety and tolerability of AZL-M were comparable with valsartan.
CONCLUSIONS


AZL-M was noninferior to valsartan at the 40-mg dose and superior to valsartan at the 80-mg dose in reducing trough scSBP, and showed acceptable safety-consistent with the AZL-M safety profile in other populations-in Chinese adults with hypertension.
TRIAL REGISTRATION NUMBER


NCT02480764.",2020,Treatment-emergent adverse events had similar incidence (52.8%-56.5%) across the treatment groups and were generally mild or moderate.,"['612 patients (mean age, 57.1 years; 57.5% male', 'Chinese patients with essential hypertension was undertaken', 'Chinese patients with essential hypertension', 'patients with hypertension', 'Chinese patients aged ≥18 years with essential hypertension', 'Chinese adults with hypertension']","['AZL-M', 'valsartan', 'AZL-M with valsartan', 'AZL-M 40\u200amg (n\u200a=\u200a199), or valsartan', 'azilsartan medoxomil', 'Azilsartan medoxomil (AZL-M']","['Baseline mean scSBP', 'mean reduction in trough scSBP', 'efficacy (antihypertensive effect), safety, and tolerability', 'safety and tolerability of AZL-M', 'Mean reduction in 24-hour mean systolic blood pressure', 'Dizziness', 'trough sitting clinic systolic blood pressure (scSBP) and ambulatory blood pressure monitoring parameters']","[{'cui': 'C4517834', 'cui_str': '612'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C2698291', 'cui_str': 'azilsartan medoxomil'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C2979834', 'cui_str': 'azilsartan medoxomil 40 MG'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2698291', 'cui_str': 'azilsartan medoxomil'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",612.0,0.157334,Treatment-emergent adverse events had similar incidence (52.8%-56.5%) across the treatment groups and were generally mild or moderate.,"[{'ForeName': 'Jiahui', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Beijing.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Beijing.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Lv', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Beijing.'}, {'ForeName': 'Zhanquan', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, People's Hospital of Liaoning Province, Liaoning.""}, {'ForeName': 'Zeqi', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Department of Cardiology, the First Affiliated Hospital of NanChang University, Jiangxi.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of Cardiology, the Affiliated Hospital of Xuzhou Medical College.'}, {'ForeName': 'Chengchun', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Cardiology, Southeast University, Zhongda Hospital, Jiangsu.'}, {'ForeName': 'Zhuhua', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': ""Department of Cardiology, Tianjin People's Hospital, Tianjin.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Hebei Cangzhou Central Hospital, Hebei.'}, {'ForeName': 'Mingzhi', 'Initials': 'M', 'LastName': 'Long', 'Affiliation': 'Department of Cardiology, Nanjing Medical University Affiliated 2nd Hospital, Jiangsu, China.'}, {'ForeName': 'Michie', 'Initials': 'M', 'LastName': 'Hisada', 'Affiliation': 'Global Patient Safety Evaluation, Takeda Development Center Americas, Inc., Deerfield, IL.'}, {'ForeName': 'Jingtao', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Statistics and Quantitative Sciences, Takeda Development Center Americas, Inc., Cambridge, MA, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'Clinical Science, Takeda Development Center Asia, Pte. Ltd., Shanghai, China.'}, {'ForeName': 'Changsheng', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiology, Beijing Anzhen Hospital, Beijing.'}]",Medicine,['10.1097/MD.0000000000021465']
1857,32768682,Weight management for adults with mobility related disabilities: Rationale and design for an 18-month randomized trial.,"Adults with mobility related disabilities (MRDs) represent an underserved group with a high prevalence of overweight/obesity and limited options for weight management. We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity. However, the costs/logistics associated with intervention delivery by individual home visits limits the potential for scaling and implementation of this approach. Thus, we will conduct a two-arm randomized trial in 128 overweight/obese adults with MRDs to compare weight loss (6 mos.) and maintenance (12 mos.) between interventions utilizing the eSLD, behavioral counseling, and increased physical activity delivered to individual participants in their homes or delivered to groups of participants in their homes remotely via video conferencing. The primary aim will compare weight loss between interventions arms across 6 months. Secondarily, we will compare weight loss (0-18 mos.), the proportion of participants who achieve clinically meaningful weight loss (≥5%) from 0 to 6 and 0 to18 months, and changes in quality of life from 0 to 6 and 0 to 18 months between interventions arms. We will also conduct cost, cost-effectiveness and contingent valuation comparisons and explore the influence of behavioral session attendance, compliance with the recommendations for diet and physical activity, self-monitoring of diet and physical activity, barriers to physical activity, sleep quality, and medications on weight change across 6 and 18 months. NCT REGISTRATION: NCT04046471.",2020,"We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity.","['adults with mobility related disabilities', 'adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an', '128 overweight/obese adults with MRDs to compare weight loss (6 mos.) and maintenance (12 mos.) between', 'Adults with mobility related disabilities (MRDs']","['Weight management', 'enhanced Stop Light Diet (eSLD', 'interventions utilizing the eSLD, behavioral counseling, and increased physical activity delivered to individual participants in their homes or delivered to groups of participants in their homes remotely via video conferencing']","['quality of life', 'weight loss', 'physical activity, sleep quality, and medications on weight change', 'meaningful weight loss']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C1303013', 'cui_str': 'Baseline weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0920298', 'cui_str': 'Weight maintenance regimen'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0419181', 'cui_str': 'Light diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}, {'cui': 'C4039165', 'cui_str': 'Increased physical activity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",128.0,0.0374796,"We previously demonstrated clinically meaningful 12-month weight loss in adults with MRDs (-6.2%, 36% ≥5% of baseline weight) using an enhanced Stop Light Diet (eSLD) delivered using at home face-to-face behavioral sessions and optional physical activity.","[{'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Washburn', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: rwashburn@ku.edu.'}, {'ForeName': 'Lauren T', 'Initials': 'LT', 'LastName': 'Ptomey', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: lptomey@kumc.edu.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Gorczyca', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: agorczyca@kumc.edu.'}, {'ForeName': 'Patricia R', 'Initials': 'PR', 'LastName': 'Smith', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: psmith18@kumc.edu.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Mayo', 'Affiliation': 'Department of Biostatistics and Data Science, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: mmayo@kumc.edu.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lee', 'Affiliation': 'Department of Population Health, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: rlee2@kumc.edu.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Internal Medicine, The University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS 66160, USA. Electronic address: jdonnelly@ku.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106098']
1858,32768792,The emotion regulatory function of online social networking: Preliminary experimental evidence.,"Correlational research suggests that emotion regulation deficits, which are known risk factors for substance addictions, may also play a role in the development of problem behaviors such as excessive or maladaptive use of social networking sites (SNS). This study sought to experimentally assess the hypothesized emotion regulatory function of SNS use. 139 undergraduates (53.2% female) were randomized to view brief movie clips known to reliably induce positive (37.4%), negative (29.5%), or neutral mood (33.1%) and then to browse a SNS (46.8%) or control website (53.2%). Mood and subjective urge to access SNS and the Internet were assessed before and after viewing the movie clips and browsing the websites. Participants meeting criteria for ""moderate"" levels of disordered SNS use self-reported significantly greater deficits in emotion regulation (p = .02, η p 2  = 0.14). Increases in positive and negative affect following the mood induction were associated with a decrease in subjective urge to access SNS (r = -0.22, p = .02, r = -0.28, p = .002, respectively). Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09). We replicate previous findings of greater emotion regulation deficits in individuals endorsing problematic SNS use. Increased positive and negative affect resulted in decreased urge to access SNS, suggesting that social networking may primarily serve to counter low-arousal emotions like boredom. Data provide initial experimental evidence to support the hypothesized emotion regulatory function of SNS, with SNS exposure resulting in increased positive affect. Findings suggest that interventions targeting problematic SNS use should incorporate strategies for improved emotion regulation.",2020,"Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09).","['individuals endorsing problematic SNS use', '139 undergraduates (53.2% female']",[],"['subjective urge to access SNS', 'deficits in emotion regulation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0379552,"Time spent browsing SNS resulted in significantly greater increases in self-reported positive affect, compared to the control website (p = .001, η p 2  = 0.09).","[{'ForeName': 'Rae D', 'Initials': 'RD', 'LastName': 'Drach', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, United States.'}, {'ForeName': 'Natalia C', 'Initials': 'NC', 'LastName': 'Orloff', 'Affiliation': ""Department of Psychology, University at Albany, State University of New York, United States; Department of Child and Adolescent Psychiatry and Behavioral Sciences, Children's Hospital of Philadelphia, United States.""}, {'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Hormes', 'Affiliation': 'Department of Psychology, University at Albany, State University of New York, United States. Electronic address: jhormes@albany.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106559']
1859,32779919,[Is osteoarthritis an inflammatory disease after all?; prednisolone effective in osteoarthritis of the hand].,"There are very few treatment options that modify the course of osteoarthritis (OA) of the hand; the only current treatment options are physiotherapy and analgesics. At the moment, OA is regarded as a disease of the entire joint, with involvement of cartilage, bone, synovium, ligaments and muscles and new treatment options can focus on these structures. In a double-blind, placebo-controlled trial, treatment of patients with inflammatory OA of the hand (with pain, soft-tissue swelling and an ultrasound picture characteristic of inflammation) with 10 mg prednisolone per day for 6 weeks resulted in a larger decrease in pain than placebo did. This short-term study does certainly not provide the definitive answer for treating this chronic disease, and long-term use of prednisolone is associated with several side-effects. Nevertheless, this breakthrough study clearly demonstrates that the use of anti-inflammatory, anti-rheumatic medication may have a favourable effect on inflammatory OA of the hand. Studies of anti-inflammatory drugs with a better long-term safety profile will be welcome.",2020,There are very few treatment options that modify the course of osteoarthritis (OA) of the hand; the only current treatment options are physiotherapy and analgesics.,"['patients with inflammatory OA of the hand (with pain, soft-tissue swelling and an ultrasound picture characteristic of inflammation']","['prednisolone', 'placebo']",['pain'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037580', 'cui_str': 'Soft tissue swelling'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.0822556,There are very few treatment options that modify the course of osteoarthritis (OA) of the hand; the only current treatment options are physiotherapy and analgesics.,"[{'ForeName': 'Willem F', 'Initials': 'WF', 'LastName': 'Lems', 'Affiliation': 'Amsterdam UMC, locatie VUmc, afd. Reumatologie, Amsterdam.'}]",Nederlands tijdschrift voor geneeskunde,[]
1860,32779931,[A requiem for prehydration in CT imaging?],"A recently published randomised controlled trial (the Kompas trial) compared prehydration with sodium bicarbonate solution with no prehydration in patients with chronic kidney disease (eGFR 30-60 ml/min per 1.73 m2) undergoing elective CT scanning with intravenous contrast agent. Although patients were considered to be at risk for postcontrast acute kidney injury (PC-AKI), average serum creatinine concentration increased by 2% after 5-7 days with no serious persistent decline in renal function. No significant differences were found between treatment and no treatment arms of the study. Results are in agreement with previous trials and confirm that risk of clinically relevant PC-AKI is very low and that prehydration is not warranted in this group of patients. Patients with an eGFR of less than 30 ml/min per 1.73 m2 and multiple AKI risk factors have a higher risk of PCI-AKI and may benefit from prehydration, although the risk-benefit balance remains unclear.",2020,No significant differences were found between treatment and no treatment arms of the study.,['patients with chronic kidney disease (eGFR 30-60 ml/min per 1.73 m2) undergoing'],"['prehydration with sodium bicarbonate solution with no prehydration', 'elective CT scanning with intravenous contrast agent']","['renal function', 'serum creatinine concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}]","[{'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0756507,No significant differences were found between treatment and no treatment arms of the study.,"[{'ForeName': 'M G H', 'Initials': 'MGH', 'LastName': 'Betjes', 'Affiliation': 'Erasmus MC, afd. Interne Geneeskunde, Rotterdam.'}]",Nederlands tijdschrift voor geneeskunde,[]
1861,32762882,A randomized controlled trial of pegylated interferon-alpha with tenofovir disoproxil fumarate for hepatitis B e antigen-negative chronic hepatitis B: A 48-week follow-up study.,"BACKGROUND


Recent studies report incongruent finds regarding the addition of pegylated interferon -alpha (Peg- IFNα) to nucleos(t)ide analogues. This study was designed to compare the efficacy of Peg- IFNα and tenofovir disoproxil fumarate (TDF) combination therapy with each of the treatments separately.
METHODS


In this open-label, randomized clinical trial, treatment-naive hepatitis B e antigen (HBeAg)-negative patients were randomly assigned to three treatment groups: Group A: Peg- IFNα (180 mcg/week) with TDF (300 mg/day); Group B: TDF (300 mg/day); and Group C: Peg- IFNα (180 mcg/week). The intervention spanned 48 weeks and patients were followed up every 12 weeks. The primary end-point was HBV DNA load <20 IU/mL.
RESULTS


Groups A, B and C each comprised of 22, 23 and 22 patients, respectively. The number of patients with HBV DNA suppression in group A was significantly higher compared to groups B and C (P = 0.034). No significant difference was observed in the normalization trends of serum ALT levels between the three groups (P = 0.082). At week 48, combination therapy was significantly more effective in suppressing HBV DNA concentration to below the level of detection than TDF monotherapy (OR = 2.1, 95%CI: 1.18-4.15; P = 0.034). Furthermore, a comparison between monotherapy arms revealed that both interventions had similar effects on the overall outcome (OR = 1.24, 95%CI: 1.02-5.8; P = 0.062).
CONCLUSION


A Peg- IFNα and TDF combination therapy resulted in improved virologic response and was safe in HBeAg negative patients. Monotherapy with Peg-IFNα or TDF procured limited benefits in comparison.
TRIAL REGISTRATION


This study was registered in the Iranian Registry of Clinical Trials (IRCT20181113041635N1).",2020,No significant difference was observed in the normalization trends of serum ALT levels between the three groups (P = 0.082).,"['hepatitis B e antigen-negative chronic hepatitis B', 'treatment-naive hepatitis B e antigen (HBeAg)-negative patients']","['pegylated interferon-alpha with tenofovir disoproxil fumarate', 'TDF', 'Monotherapy with Peg-IFNα or TDF', 'pegylated interferon -alpha', 'TDF combination therapy', 'Peg- IFNα and tenofovir disoproxil fumarate (TDF) combination therapy', 'Peg- IFNα']","['serum ALT levels', 'number of patients with HBV DNA suppression', 'virologic response', 'HBV DNA load <20 IU/mL', 'suppressing HBV DNA concentration']","[{'cui': 'C0948827', 'cui_str': 'Hepatitis B e antigen negative'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002199', 'cui_str': 'interferon alfa natural'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0036828', 'cui_str': 'SGPT'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0439458', 'cui_str': 'IU/mL'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.094267,No significant difference was observed in the normalization trends of serum ALT levels between the three groups (P = 0.082).,"[{'ForeName': 'Mansour', 'Initials': 'M', 'LastName': 'Bahardoust', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran; Department of Epidemiology, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mokhtare', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Barati', 'Affiliation': 'Pediatric Infectious Diseases Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Bagheri-Hosseinabadi', 'Affiliation': 'Department of Clinical Biochemistry, Faculty of Medicine, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.'}, {'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Karimi Behnagh', 'Affiliation': 'Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Keyvani', 'Affiliation': 'Department of Virology, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Agah', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran. Electronic address: agah.sh@iums.ac.ir.'}]",Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy,['10.1016/j.jiac.2020.07.005']
1862,32762995,"Mapping From Visual Acuity to EQ-5D, EQ-5D With Vision Bolt-On, and VFQ-UI in Patients With Macular Edema in the LEAVO Trial.","OBJECTIVES


Mappings to convert clinical measures to preference-based measures of health such as the EQ-5D-3L are sometimes required in cost-utility analyses. We developed mappings to convert best-corrected visual acuity (BCVA) to the EQ-5D-3L, the EQ-5D-3L with a vision bolt-on (EQ-5D V), and the Visual Functioning Questionnaire-Utility Index (VFQ-UI) in patients with macular edema caused by central retinal vein occlusion.
METHODS


We used data from Lucentis, Eylea, Avastin in vein occlusion (LEAVO), which is a phase-3 randomized controlled trial comparing ranibizumab, aflibercept, and bevacizumab in 463 patients with observations at 6 time points. We estimated adjusted limited dependent variable mixture models consisting of 1 to 4 distributions (components) using BCVA in each eye, age, and sex to predict utility within the components and BCVA as a determinant of component membership. We compared model fit using mean error, mean absolute error, root mean square error, Akaike information criteria, Bayesian information criteria, and visual inspection of mean predicted and observed utilities and cumulative distribution functions.
RESULTS


Mean utility scores were 0.82 for the EQ-5D-3L, 0.79 for the EQ-5D V, and 0.88 for the VFQ-UI. The best-fitting models for the EQ-5D and EQ-5D V had 2 components (with means of approximately 0.44 and 0.85), and the best-fitting model for VFQ-UI had 3 components (with means of approximately 0.95, 0.74, and 0.90).
CONCLUSIONS


Models with multiple components better predict utility than those with single components. This article provides a valuable addition to the literature, in which previous mappings in visual acuity have been limited to linear regressions, resulting in unfounded assumptions about the distribution of the dependent variable.",2020,"Mean utility scores were 0.82 for the EQ-5D-3L, 0.79 for the EQ-5D V, and 0.88 for the VFQ-UI.","['patients with macular edema caused by central retinal vein occlusion', '463 patients with observations at 6 time points', 'Patients With Macular Edema in the LEAVO Trial']","['ranibizumab, aflibercept, and bevacizumab', 'Lucentis, Eylea, Avastin in vein occlusion (LEAVO']","['mean error, mean absolute error, root mean square error, Akaike information criteria, Bayesian information criteria, and visual inspection of mean predicted and observed utilities and cumulative distribution functions', 'Mean utility scores', 'Visual Functioning Questionnaire-Utility Index (VFQ-UI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0154841', 'cui_str': 'Central retinal vein occlusion'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1721374', 'cui_str': 'Lucentis'}, {'cui': 'C3248025', 'cui_str': 'Eylea'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C0948441', 'cui_str': 'Venous occlusion'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C3248025', 'cui_str': 'Eylea'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C0948441', 'cui_str': 'Venous occlusion'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",463.0,0.141225,"Mean utility scores were 0.82 for the EQ-5D-3L, 0.79 for the EQ-5D V, and 0.88 for the VFQ-UI.","[{'ForeName': 'Becky M', 'Initials': 'BM', 'LastName': 'Pennington', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK. Electronic address: b.pennington@sheffield.ac.uk.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Hernández-Alava', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Hykin', 'Affiliation': 'National Institute for Health Research Moorfields Biomedical Research Centre, London, England, UK.'}, {'ForeName': 'Sobha', 'Initials': 'S', 'LastName': 'Sivaprasad', 'Affiliation': 'National Institute for Health Research Moorfields Biomedical Research Centre, London, England, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Flight', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK.'}, {'ForeName': 'Abualbishr', 'Initials': 'A', 'LastName': 'Alshreef', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Brazier', 'Affiliation': 'School of Health and Related Research, University of Sheffield, Sheffield, England, UK.'}]",Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research,['10.1016/j.jval.2020.03.008']
1863,32763967,Value of FEops HEARTguide patient-specific computational simulations in the planning of left atrial appendage closure with the Amplatzer Amulet closure device: rationale and design of the PREDICT-LAA study.,"BACKGROUND


Optimal preprocedural planning is essential to ensure successful device closure of the left atrial appendage (LAA).
DESIGN


The PREDICT-LAA study is a prospective, international, multicentre, randomised controlled trial (ClinicalTrials.gov NCT04180605). Two hundred patients eligible for LAA closure with an Amplatzer Amulet device (Abbott, USA) will be enrolled in the study. Patients will be allocated to a computational simulation arm (experimental) or standard treatment arm (control) using a 1:1 randomisation. For patients randomised to the computational simulation arm, preprocedural planning will be based on the analysis of cardiac computed tomography (CCT)-based patient-specific computational simulations (FEops HEARTguide, Ghent, Belgium) in order to predict optimal device size and position. For patients in the control arm, preprocedural planning will be based on local practice including CCT analysis. The LAA closure procedure and postprocedural antithrombotic therapy will follow local practice in both arms. The primary endpoint of the study is incomplete LAA closure and device-related thrombus as assessed at 3 months postprocedural CCT. Secondary endpoints encompass procedural efficiency (number of devices used, number of repositioning, procedural time, radiation exposure, contrast dye), procedure-related complications within 7 days postprocedure and a composite of all-cause death and thromboembolic events at 12 months.
CONCLUSION


The objective of the PREDICT-LAA study is to test the hypothesis that a preprocedural planning for LAA closure with the Amplatzer Amulet device based on patient-specific computational simulations can result in a more efficient procedure, optimised procedural outcomes and better clinical outcomes as compared with a standard preprocedural planning.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT04180605).",2020,"Secondary endpoints encompass procedural efficiency (number of devices used, number of repositioning, procedural time, radiation exposure, contrast dye), procedure-related complications within 7 days postprocedure and a composite of all-cause death and thromboembolic events at 12 months.
","['Two hundred patients eligible for LAA closure with an Amplatzer Amulet device (Abbott, USA']",['computational simulation arm (experimental) or standard treatment arm (control'],"['incomplete LAA closure and device-related thrombus as assessed at 3 months postprocedural CCT', 'procedural efficiency (number of devices used, number of repositioning, procedural time, radiation exposure, contrast dye), procedure-related complications within 7 days postprocedure and a composite of all-cause death and thromboembolic events']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1298904', 'cui_str': 'Device used'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}]",200.0,0.183072,"Secondary endpoints encompass procedural efficiency (number of devices used, number of repositioning, procedural time, radiation exposure, contrast dye), procedure-related complications within 7 days postprocedure and a composite of all-cause death and thromboembolic events at 12 months.
","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Garot', 'Affiliation': 'Department of Cardiology, Institut Cardiovasculaire Paris Sud, Massy, Île-de-France, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Iriart', 'Affiliation': 'Pediatric and Congenital Cardiology, University Hospital of Bordeaux, Pessac, MS, France.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Aminian', 'Affiliation': 'Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Hainaut, Belgium.'}, {'ForeName': 'Joelle', 'Initials': 'J', 'LastName': 'Kefer', 'Affiliation': 'Division of Cardiology, Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Freixa', 'Affiliation': 'Cardiovascular Institute, Hospital Clinic de Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Cruz-Gonzalez', 'Affiliation': 'Department of Cardiology, Hospital Clínico Universitario de Salamanca, Salamanca, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Berti', 'Affiliation': 'Cardiology Unit, Fondazione CNR Regione Toscana, Massa, Italy.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Rosseel', 'Affiliation': 'Department of Cardiology, University Hospital Galway, Galway, Ireland.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Cardiology, Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Korsholm', 'Affiliation': 'Department of Cardiology, Aarhus Universitetshospital Skejby, Aarhus, Denmark.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Odenstedt', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Goteborg, Sweden.'}, {'ForeName': 'Jens-Erik', 'Initials': 'JE', 'LastName': 'Nielsen-Kudsk', 'Affiliation': 'Department of Cardiology, Aarhus Universitetshospital Skejby, Aarhus, Denmark.'}, {'ForeName': 'Jaqueline', 'Initials': 'J', 'LastName': 'Saw', 'Affiliation': 'Department of Cardiology, Vancouver General Hospital, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Sondergaard', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'De Backer', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark ole.debacker@gmail.com.'}]",Open heart,['10.1136/openhrt-2020-001326']
1864,32764081,"Acupuncture for acute non-specific low back pain: a randomised, controlled, multicentre intervention study in general practice-the Acuback study.","OBJECTIVES


The aim of this study was to evaluate whether a single treatment session of acupuncture, when applied in addition to standard treatment for acute low back pain (ALBP), reduces the time to recovery compared with standard treatment alone.
DESIGN


A multicentre, randomised, controlled trial.
SETTING


Conducted at 11 Norwegian general practitioners' (GPs') offices.
PARTICIPANTS


171 adults aged 20-55 years seeking their GP for ALBP (≤14 days) between March 2014 and March 2017. Patients with secondary back pain and previous sick leave and acupuncture treatment was excluded.
INTERVENTIONS


The participants were randomised to either the control group (CG) or the acupuncture group (AG) by online software. The CG received standard treatment according to the Norwegian guidelines, while the AG received one session of Western medical acupuncture treatment in addition to standard treatment. The statistician was blinded to group status.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcome was median days to recovery. Secondary outcomes were pain intensity, global improvement, back-specific functional status, sick leave, medication and adverse effects.
RESULTS


185 participants were randomised, 95 in the CG and 90 in the AG. 14 participants did not receive the allocated intervention and 4 were excluded from the analysis. Thus, 167 participants were included in the analysis, 86 in the CG and 81 in the AG. The groups were similar according to baseline characteristics. The median time to recovery was 14 days for the CG and 9 days for the AG, HR 1.37 (95% CI 0.95 to 1.96), (p=0.089). No serious adverse effects were reported.
CONCLUSIONS


We did not find any statistically significant reduction in time-to-recovery after a single session of acupuncture for ALBP compared with standard care.
TRIAL REGISTRATION NUMBER


NCT01439412.",2020,"We did not find any statistically significant reduction in time-to-recovery after a single session of acupuncture for ALBP compared with standard care.
","['Patients with secondary back pain and previous sick leave and acupuncture treatment was excluded', '171 adults aged 20-55 years seeking their GP for ALBP (≤14 days) between March 2014 and March 2017', ""Conducted at 11 Norwegian general practitioners' (GPs') offices"", '14 participants did not receive the allocated intervention and 4 were excluded from the analysis', 'acute low back pain (ALBP', '167 participants were included in the analysis, 86 in the CG and 81 in the AG', 'acute non-specific low back pain', '185 participants were randomised, 95 in the CG and 90 in the AG']","['acupuncture', 'Acupuncture', 'control group (CG) or the acupuncture group (AG) by online software']","['median days to recovery', 'time-to-recovery', 'pain intensity, global improvement, back-specific functional status, sick leave, medication and adverse effects', 'median time to recovery', 'serious adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0457950', 'cui_str': 'Acute low back pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0017319', 'cui_str': 'General physician'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",167.0,0.197259,"We did not find any statistically significant reduction in time-to-recovery after a single session of acupuncture for ALBP compared with standard care.
","[{'ForeName': 'Trygve', 'Initials': 'T', 'LastName': 'Skonnord', 'Affiliation': 'Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway trygve.skonnord@medisin.uio.no.'}, {'ForeName': 'Holgeir', 'Initials': 'H', 'LastName': 'Skjeie', 'Affiliation': 'Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Brekke', 'Affiliation': 'General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Atle', 'Initials': 'A', 'LastName': 'Klovning', 'Affiliation': 'Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Margreth', 'Initials': 'M', 'LastName': 'Grotle', 'Affiliation': 'Department of Physiotherapy, Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Aas', 'Affiliation': 'Department of Health Management and Health Economics, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Ibrahimu', 'Initials': 'I', 'LastName': 'Mdala', 'Affiliation': 'General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Fetveit', 'Affiliation': 'General Practice Research Unit (AFE), Department of General Practice, Institute of Health and Society, University of Oslo, Oslo, Norway.'}]",BMJ open,['10.1136/bmjopen-2019-034157']
1865,32764089,Study protocol for a cluster randomised controlled trial testing the effectiveness of the 'High schools High on life' intervention on reducing excessive drinking in Danish high schools.,"INTRODUCTION


This paper describes the evaluation design of the 'High schools High on life' intervention; a school-based intervention to reduce excessive drinking among high school students in Denmark. The intervention includes a school environmental component to limit access to alcohol at school, a school-educational component to change social norms around alcohol among first year students and a parental component addressing parents' knowledge and attitudes towards alcohol.
METHODS AND DESIGN


The study will employ a cluster randomised controlled study design and will include a random sample of 16 high schools randomly allocated 1:1 to either intervention or control group. Target group: first year high school students. Timeline: baseline survey: January to March 2019, collected as part of the Danish National Youth Study 2019. Delivery of intervention: April 2019 to March 2020. Follow-up survey: April to May 2020.
PRIMARY OUTCOME MEASURE


30% reduction in mean number of binge-drinking episodes (five or more alcoholic drinks on one occasion) within the last 30 days.
SECONDARY OUTCOME MEASURES


proportion of students who drink alcohol, mean weekly alcohol consumption, alcohol intake at last school party, alcohol intake at the school during last school party, proportion of students who agree to be able to have fun at a party without drinking and the proportion of students who think alcohol plays a too dominant part at the school. Implementation will be monitored through process evaluation.
ETHICS AND DISSEMINATION


The Scientific Ethics Committees for the Capital Region of Denmark has declared that the trial is not subject to notification (jnr. 19021957). The study is registered at the Research an Innovation Office at University of Southern Denmark (ref: 10.314) allowing collection of personal data. Results will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER


NCT03906500.",2020,The Scientific Ethics Committees for the Capital Region of Denmark has declared that the trial is not subject to notification (jnr.,"['Danish high schools', 'Target group: first year high school students', 'Timeline: baseline survey: January to March 2019, collected as part of the Danish National Youth Study 2019', 'random sample of 16 high schools', 'high school students in Denmark']","[""school environmental component to limit access to alcohol at school, a school-educational component to change social norms around alcohol among first year students and a parental component addressing parents' knowledge and attitudes towards alcohol"", ""High schools High on life' intervention"", 'school-based intervention']","['proportion of students who drink alcohol, mean weekly alcohol consumption, alcohol intake at last school party, alcohol intake', 'mean number of binge-drinking episodes ']","[{'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0282121', 'cui_str': 'Baseline Survey'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",16.0,0.0307791,The Scientific Ethics Committees for the Capital Region of Denmark has declared that the trial is not subject to notification (jnr.,"[{'ForeName': 'Veronica Sofie Clara', 'Initials': 'VSC', 'LastName': 'Pisinger', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark vepi@sdu.dk.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Hoffmann', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}, {'ForeName': 'Johanne Aviaja', 'Initials': 'JA', 'LastName': 'Rosing', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Grønbæk', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}, {'ForeName': 'Janne Schurmann', 'Initials': 'JS', 'LastName': 'Tolstrup', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}, {'ForeName': 'Lau', 'Initials': 'L', 'LastName': 'Thygesen', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Krølner', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Syddanmark, Denmark.'}]",BMJ open,['10.1136/bmjopen-2020-038857']
1866,32766757,Long-Term Glycemic Variability and Vascular Complications in Type 2 Diabetes: Post Hoc Analysis of the FIELD Study.,"AIMS


To investigate whether long-term glycemic variability (GV) is associated with vascular complication development in type 2 diabetes.
METHODS


In a post hoc FIELD trial analysis, GV was calculated as the standard deviation and coefficient of variation (CV) of glycated hemoglobin A1c (HbA1c) and fasting plasma glucose. Baseline variables were compared across quartiles of on-study variability by chi square and ANOVA. Prospective associations between baseline to 2-year GV and subsequent vascular and mortality outcomes were analyzed using landmark logistic and Cox proportional hazards regression.
RESULTS


Baseline factors associated with higher on-study GV included younger age, male gender, longer diabetes duration, and higher pharmacological therapies usage. Both HbA1c and fasting glucose CV were associated with increased risk of microvascular complications (HR 1.02 [95% CI, 1.01-1.03] P < 0.01; and HR 1.01 [95% CI, 1.00-1.01] P < 0.001, respectively). HbA1c and fasting glucose CV were associated with increased cardiovascular disease (HR 1.02 [95% CI, 1.00-1.04]; and HR 1.01 [95% CI, 1.00-1.02], both P < 0.05). HbA1c CV associated with increased stroke (HR 1.03 [95% CI, 1.01-1.06) P < 0.01). Glucose CV associated with increased coronary events (HR 1.01 [95% CI, 1.00-1.02] P < 0.05). Both HbA1c and glucose CV associated with increased total mortality (HR 1.04 [95% CI, 1.02-1.06]; and HR 1.01 [95% CI, 1.01-1.02], both P < 0.001) and noncardiovascular mortality (HR 1.05 [95% CI, (1.03-1.07]; and HR 1.02 [95% CI, 1.01-1.03], both P < 0.001). HbA1c CV associated with coronary mortality (HR 1.04 [95% CI, 1.01-1.07] P < 0.05).
CONCLUSIONS


Long-term GV was associated with increased risk of vascular outcomes in type 2 diabetes.",2020,"HbA1c and fasting glucose CV were associated with increased cardiovascular disease (HR 1.02 (95% CI 1.00-1.04); HR 1.01 (95% CI 1.00-1.02), both p<0.05).",['Type 2 diabetes'],['long-term glycaemic variability (GV'],"['Glucose CV associated with increased coronary events', 'cardiovascular disease', 'risk of vascular outcomes', 'stroke', 'total mortality', 'HbA1c and fasting glucose CV', 'non-cardiovascular mortality', 'standard deviation and coefficient of variation (CV) of HbA1c and fasting plasma glucose', 'coronary mortality', 'risk of microvascular complications']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.264684,"HbA1c and fasting glucose CV were associated with increased cardiovascular disease (HR 1.02 (95% CI 1.00-1.04); HR 1.01 (95% CI 1.00-1.02), both p<0.05).","[{'ForeName': 'Emma S', 'Initials': 'ES', 'LastName': 'Scott', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trial Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Andrzej S', 'Initials': 'AS', 'LastName': 'Januszewski', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trial Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': ""O'Connell"", 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trial Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Fulcher', 'Affiliation': 'Department of Endocrinology and Diabetes, Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Scott', 'Affiliation': 'Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Antero', 'Initials': 'A', 'LastName': 'Kesaniemi', 'Affiliation': 'Oulu Medical Research Centre, University of Oulu and Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trial Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Colagiuri', 'Affiliation': 'The Boden Institute, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Keech', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trial Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Alicia J', 'Initials': 'AJ', 'LastName': 'Jenkins', 'Affiliation': 'National Health and Medical Research Council (NHMRC) Clinical Trial Centre, University of Sydney, Sydney, Australia.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa361']
1867,32768154,Ca2+ channel dynamics explain the nonlinear neuroplasticity induction by cathodal transcranial direct current stimulation over the primary motor cortex.,"Transcranial direct current stimulation (tDCS) induces polarity-dependent neuroplasticity: with conventional protocols, anodal tDCS results in excitability enhancement while cathodal stimulation reduces excitability. However, partially non-linear responses are observed with increased stimulation intensity and/or duration. Cathodal tDCS with 2 mA for 20 min reverses the excitability-diminishing plasticity induced by stimulation with 1 mA into excitation, while cathodal tDCS with 3 mA again results in excitability diminution. Since tDCS generates NMDA receptor-dependent neuroplasticity, such non-linearity could be explained by different levels of calcium concentration changes, which have been demonstrated in animal models to control for the directionality of plasticity. In this study, we tested the calcium dependency of non-linear cortical plasticity induced by cathodal tDCS in human subjects in a placebo controlled, double-blind and randomized design. The calcium channel blocker flunarizine was applied in low (2.5 mg), medium (5 mg) or high (10 mg) dosages before 20 min cathodal motor cortex tDCS with 3 mA in 12 young healthy subjects. After-effects of stimulation were monitored with TMS-induced motor evoked potentials (MEPs) until 2 h after stimulation. The results show that motor cortical excitability-diminishing after-effects of stimulation were unchanged, diminished, or converted to excitability enhancement with low, medium and high dosages of flunarizine. These results suggest a calcium-dependency of the directionality of tDCS-induced neuroplasticity, which may have relevant implications for future basic and clinical research.",2020,"Cathodal tDCS with 2 mA for 20 min reverses the excitability-diminishing plasticity induced by stimulation with 1 mA into excitation, while cathodal tDCS with 3 mA again results in excitability diminution.","['human subjects in a', '12 young healthy subjects']","['Transcranial direct current stimulation (tDCS', 'calcium channel blocker flunarizine', 'medium (5\xa0mg) or high (10\xa0mg) dosages before 20\xa0min cathodal motor cortex tDCS', 'cathodal tDCS', 'flunarizine', 'placebo']","['TMS-induced motor evoked potentials (MEPs', 'motor cortical excitability-diminishing after-effects of stimulation', 'excitability diminution', 'excitability-diminishing plasticity']","[{'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0016295', 'cui_str': 'Flunarizine'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0332511', 'cui_str': 'Decreased size'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}]",12.0,0.0831006,"Cathodal tDCS with 2 mA for 20 min reverses the excitability-diminishing plasticity induced by stimulation with 1 mA into excitation, while cathodal tDCS with 3 mA again results in excitability diminution.","[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Mosayebi-Samani', 'Affiliation': 'Department Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Ardeystr. 67, 44139 Dortmund, Germany; Institute of Biomedical Engineering and Informatics, Ilmenau University of Technology, Ilmenau, Germany.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Melo', 'Affiliation': 'Department Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Ardeystr. 67, 44139 Dortmund, Germany; International Graduate School of Neuroscience, IGSN, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Desmond', 'Initials': 'D', 'LastName': 'Agboada', 'Affiliation': 'Department Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Ardeystr. 67, 44139 Dortmund, Germany; International Graduate School of Neuroscience, IGSN, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Ardeystr. 67, 44139 Dortmund, Germany; Department of Neurology, University Hospital Bergmannsheil, Bochum, Germany.'}, {'ForeName': 'Min-Fang', 'Initials': 'MF', 'LastName': 'Kuo', 'Affiliation': 'Department Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Ardeystr. 67, 44139 Dortmund, Germany. Electronic address: kuo@ifado.de.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2020.07.011']
1868,32768597,Reply to letter to the editor: 'effect of the dr. Bart application on healthcare use and clinical outcomes in people with osteoarthritis of the knee and/or hip in the Netherlands - a randomized controlled trial'.,,2020,,['people with osteoarthritis of the knee and/or hip in the Netherlands'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]",[],[],,0.0830795,,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pelle', 'Affiliation': ''}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bevers', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': ''}, {'ForeName': 'F H J', 'Initials': 'FHJ', 'LastName': 'van den Hoogen', 'Affiliation': ''}, {'ForeName': 'C H M', 'Initials': 'CHM', 'LastName': 'van den Ende', 'Affiliation': ''}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.07.007']
1869,32768599,Commentary on: effect of the dr. Bart application on healthcare use and clinical outcomes in people with osteoarthritis of the knee and/or hip in the Netherlands - a randomized controlled trial.,,2020,,['people with osteoarthritis of the knee and/or hip in the Netherlands'],[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]",[],[],,0.10498,,"[{'ForeName': 'S F J', 'Initials': 'SFJ', 'LastName': 'Chudy', 'Affiliation': 'Erasmus MC, Netherlands. Electronic address: stanchudy@gmail.com.'}, {'ForeName': 'M M M', 'Initials': 'MMM', 'LastName': 'Volwater', 'Affiliation': 'Leiden University, Netherlands. Electronic address: mike_volwater@hotmail.com.'}, {'ForeName': 'Ö F', 'Initials': 'ÖF', 'LastName': 'Ozbulut', 'Affiliation': 'Department of General Practice, Erasmus MC, Netherlands. Electronic address: o.ozbulut@erasmusmc.nl.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Koes', 'Affiliation': 'Department of General Practice, Erasmus MC, Netherlands. Electronic address: b.koes@erasmusmc.nl.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.06.011']
1870,32768635,Bidirectional effects between expressive regulatory abilities and peer acceptance among Chinese adolescents.,"The current study examined potential bidirectional effects between adolescents' expressive regulation (the ability to enhance and suppress overt emotional behavior in line with situational demands) and peer interactions via two experiments. Experiment 1 tested the hypothesis that adolescents' expressive regulation affects their social acceptance from peers. Participants (N = 147) were randomly divided into three conditions and watched video clips in which a same-sex partner differed in his or her levels of expressive enhancement and suppression abilities. Results showed that participants reported greater liking of the partner when he or she was able to flexibly enhance and suppress emotional expressions in line with situational demands compared with when either one of these abilities was impaired. Experiment 2 then examined whether peer rejection reduced participants' enhancement and suppression abilities. We manipulated participants' feelings of rejection through a virtual Cyberball game. Following this manipulation (N = 100; Inclusion vs. Exclusion), we tested participants' expressive enhancement and suppression abilities, as well as their natural expressivity, via an observational task. Peer exclusion resulted in lower levels of enhancement ability and natural expressive behaviors but did not impair suppression ability. The results of these experiments suggest that both expressive enhancement and expressive suppression are important for adolescents to obtain higher peer acceptance. In addition, peer exclusion also caused impairments in expressive regulation, specifically reduced enhancement abilities. In summary, these results evidenced the bidirectional effects between expressive regulation and peer acceptance.",2020,Peer exclusion resulted in lower levels of enhancement ability and natural expressive behaviors but did not impair suppression ability.,"['Chinese adolescents', 'Participants (N\xa0=\xa0147']",['watched video clips'],"['enhancement ability and natural expressive behaviors', 'enhancement abilities', 'emotional expressions']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0175722', 'cui_str': 'Clip'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",147.0,0.0275084,Peer exclusion resulted in lower levels of enhancement ability and natural expressive behaviors but did not impair suppression ability.,"[{'ForeName': 'Yingqian', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Psychology, School of Sociology and Psychology, Central University of Finance and Economics, Beijing 100081, China; Department of Educational Psychology, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, China. Electronic address: wangyingqian@link.cuhk.edu.hk.'}, {'ForeName': 'Skyler T', 'Initials': 'ST', 'LastName': 'Hawk', 'Affiliation': 'Department of Educational Psychology, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, China.'}, {'ForeName': 'Wenqing', 'Initials': 'W', 'LastName': 'Zong', 'Affiliation': 'Department of Educational Psychology, The Chinese University of Hong Kong, Shatin, NT, Hong Kong, China.'}]",Journal of experimental child psychology,['10.1016/j.jecp.2020.104891']
1871,32769643,Botulinum Toxin A as a Treatment for Provoked Vestibulodynia: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate pain reduction after two injections of 50 units botulinum toxin A compared with placebo for provoked vestibulodynia.
METHODS


We conducted a double-blinded, placebo-controlled randomized trial of 50 units botulinum toxin A or placebo injected in the bulbocavernosus muscles twice, 3 months apart, in women with provoked vestibulodynia. Primary outcome was self-reported dyspareunia or pain at tampon use on a visual analog scale (VAS, 0-100). Secondary outcomes were pain at weekly tampon insertion (VAS score), reduction of pelvic floor hypertonicity (measured with a vaginal manometer), adverse events, and sexual function and distress. A sample size of 38 participants for each group was calculated to achieve a statistical power of 80% based on an effect size of 20 VAS units (0-100) (mean score range 56-76±31 SD).
RESULTS


Between May 2016 and June 2018, 124 women with provoked vestibulodynia were assessed, and 88 were randomized to botulinum toxin A (BTA group, n=44) or placebo (placebo group, n=44). Primary outcome showed a lower but statistically nonsignificant pain rating by 7 VAS units (95% CI -15.0 to 0.4) in the BTA group compared with the placebo group. Secondary results showed a significant decrease in pain at weekly tampon insertion by 11 VAS units (95% CI -16.6 to 6.0) with botulinum toxin A injection. The vaginal manometer measured lower maximum contraction strength by 7 mm Hg (95% CI -12.7 to -2.4) and lower 10-second endurance strength by 4 mm Hg (95% CI -7.72 to -1.16) in the BTA group compared with the placebo group. No changes were observed for sexual function and distress, but there was a significant increase in women attempting vaginal intercourse in the BTA group (0.27, 95% CI 0.06-0.48). No severe adverse events were reported.
CONCLUSION


Twice-repeated injections of 50 units of botulinum toxin A in women with provoked vestibulodynia did not reduce dyspareunia or pain at tampon use, but secondary outcomes suggested positive effects of the treatment.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02773641.",2020,The vaginal manometer measured lower maximum contraction strength by 7 mm Hg (95% CI -12.7 to -2.4) and lower 10-second endurance strength by 4 mm,"['38 participants for each group was calculated to achieve a statistical power of 80% based on an effect size of 20 VAS units (0-100) (mean score range 56-76±31 SD', 'group, n=44', 'women with provoked vestibulodynia', 'Provoked Vestibulodynia', 'Between May 2016 and June 2018, 124 women with provoked vestibulodynia']","['Botulinum Toxin A', 'botulinum toxin A (BTA', '50 units botulinum toxin A or placebo', 'placebo (placebo', 'placebo']","['women attempting vaginal intercourse', 'sexual function and distress', 'severe adverse events', 'pain reduction', 'pain at weekly tampon insertion by 11 VAS units', 'self-reported dyspareunia or pain at tampon use on a visual analog scale (VAS, 0-100', 'pain at weekly tampon insertion (VAS score), reduction of pelvic floor hypertonicity (measured with a vaginal manometer), adverse events, and sexual function and distress', '10-second endurance strength', 'pain rating', 'maximum contraction strength', 'dyspareunia or pain']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0269084', 'cui_str': 'Vulvar vestibulitis'}, {'cui': 'C4517553', 'cui_str': '124'}]","[{'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039288', 'cui_str': 'Tampon'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026826', 'cui_str': 'Increased muscle tone'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C2720530', 'cui_str': 'Manometer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}]",124.0,0.796461,The vaginal manometer measured lower maximum contraction strength by 7 mm Hg (95% CI -12.7 to -2.4) and lower 10-second endurance strength by 4 mm,"[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Haraldson', 'Affiliation': 'Department of Clinical Sciences, Division of Obstetrics and Gynecology, Karolinska Institutet Danderyd Hospital, Stockholm, and the Center for Clinical Research, Uppsala University, County Council of Västmanland Central Hospital, and the School of Health, Care and Social Welfare, Mälardalen University, Västerås, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Mühlrad', 'Affiliation': ''}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Heddini', 'Affiliation': ''}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Nilsson', 'Affiliation': ''}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Bohm-Starke', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004008']
1872,32769647,Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence.,"OBJECTIVE


To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence.
METHODS


Four hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) against midurethral sling alone for mixed incontinence with 1 year of follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective failure, objective failure, or both. Subjective failure was defined as not meeting the minimal clinically important difference for improvement on the UDI (Urogenital Distress Inventory)-total score (26.1 points). Objective failure was not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated.
RESULTS


Previous overactive bladder medication use (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.89, 95% CI 1.10-3.25), detrusor overactivity on cystometrogram (OR 2.25, aOR 2.72, 95% CI 1.53-4.84), body mass index (OR 1.29, aOR 1.27, 95% CI 1.03-1.57), and Valsalva leak point pressure less than 60 cm H2O (OR 1.96, aOR 3.13, 95% CI 1.65-5.94) were associated with overall failure. Worse UDI urgency scores were associated with failure in the midurethral sling-alone group. Sling type (retropubic vs transobturator) was not associated with failure.
CONCLUSION


Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. This information is helpful for counseling women with mixed incontinence who are considering surgery.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT01959347.",2020,Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence.,"['Four hundred three women who participated in a randomized trial that compared', 'counseling women with mixed incontinence who are considering surgery', 'women with mixed urinary incontinence', 'Women With Mixed Urinary Incontinence']","['Midurethral Sling', 'Sling type (retropubic vs transobturator', 'perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling', 'midurethral sling', 'midurethral sling and behavioral and pelvic floor muscle therapy (combined group) against midurethral sling alone']","['Worse UDI urgency scores', 'UDI (Urogenital Distress Inventory)-total score', 'Subjective failure', 'body mass index', 'Valsalva leak point pressure', 'mean incontinence episodes', 'Overall treatment failure', 'detrusor overactivity on cystometrogram (OR 2.25, aOR', 'overall failure', 'Objective failure']","[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0869256', 'cui_str': 'Mixed urinary incontinence'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205499', 'cui_str': 'Retropubic approach'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0268849', 'cui_str': 'Detrusor overactivity'}, {'cui': 'C0200000', 'cui_str': 'Cystometrogram'}, {'cui': 'C4068875', 'cui_str': '2.25'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",403.0,0.319142,Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence.,"[{'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': ""Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, Rhode Island; the Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; the Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; the Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina; the Division of Female Pelvic Medicine & Reconstructive Surgery, Department of Obstetrics & Gynecology, Kaiser Permanente, Downey, California; the Division of Urology, Department of Surgery, Perelman School of Medicine, University of Pennsylvania Health System, Philadelphia, Pennsylvania; the Division of Urogynecology, Department of Obstetrics and Gynecology, University of New Mexico, Albuquerque, New Mexico; the Center for Urogynecology and Reconstructive Pelvic Surgery, Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, Ohio; the Department of Physical Therapy, Rangos School of Health Sciences, Duquesne University, Pittsburgh, Pennsylvania; the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland; and Social, Statistical, & Environmental Sciences, RTI International, Research Triangle Park, North Carolina.""}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': ''}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Moalli', 'Affiliation': ''}, {'ForeName': 'Alison C', 'Initials': 'AC', 'LastName': 'Weidner', 'Affiliation': ''}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Nguyen', 'Affiliation': ''}, {'ForeName': 'Ariana L', 'Initials': 'AL', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Gena', 'Initials': 'G', 'LastName': 'Dunivan', 'Affiliation': ''}, {'ForeName': 'Beri', 'Initials': 'B', 'LastName': 'Ridgeway', 'Affiliation': ''}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Borello-France', 'Affiliation': ''}, {'ForeName': 'Diane K', 'Initials': 'DK', 'LastName': 'Newman', 'Affiliation': ''}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': ''}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Carper', 'Affiliation': ''}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003989']
1873,32769657,Two Intraoperative Techniques for Midurethral Sling Tensioning: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate whether the use of a Mayo Scissor as a suburethral spacer compared with a Babcock clamp holding a loop of tape under the urethra results in different rates of abnormal bladder outcomes 12 months after retropubic midurethral sling surgery.
METHODS


The MUST (Mid-Urethral Sling Tensioning) trial was a block-randomized, double-blind, multicenter clinical trial that allocated women to have their retropubic midurethral slings tensioned by Scissor or Babcock technique. The primary outcome (abnormal bladder) was a composite of persistent stress urinary incontinence (SUI), overactive bladder, and urinary retention. Secondary outcomes included outcomes of the composite, postoperative catheterization, incontinence-related questionnaires, repeat incontinence treatment, and uroflowmetry. Sample size of 159 in each arm (N=318) was planned for a superiority trial, hypothesizing a 10% difference in primary outcome.
RESULTS


From September 2015 to December 2017, 506 women were screened and 318 were randomized. Baseline characteristics were similar in each arm. At 12 months, 253 (79.6%) women provided information on primary outcome: 40 of 128 (31.3%) patients with midurethral slings tensioned by Scissor experienced abnormal bladder, compared with 23 of 125 (18.4%) of those with midurethral slings tensioned by Babcock (P=.018, relative difference 12.9%). Secondary analyses favored Babcock for median duration of catheterization and the proportions of women experiencing urinary retention requiring sling lysis. Uroflowmetry parameters suggest the Scissor technique is more restrictive. Rates of mesh erosion were lower for the Scissor arm. No differences occurred in proportions of women experiencing patient reported persistent SUI after surgery.
CONCLUSION


Abnormal bladder outcomes were 12.9% less frequent for women with midurethral slings tensioned by Babcock. Both techniques provided a comparable patient reported cure for SUI at 12 months. Women with midurethral slings tensioned by Scissors experienced more intervention for obstruction, whereas those with midurethral slings tensioned by Babcock experienced higher rates of mesh erosion. This information about how the postoperative courses differ allows surgeons to better counsel patients preoperatively or tailor their choice of technique.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02480231.
FUNDING SOURCE


Boston Scientific.",2020,Abnormal bladder outcomes were 12.9% less frequent for women with midurethral slings tensioned by Babcock.,"['From September 2015 to December 2017, 506 women were screened and 318 were randomized', 'allocated women to have their retropubic midurethral slings tensioned by Scissor or Babcock technique']","['retropubic midurethral sling surgery', 'Babcock clamp holding a loop of tape', 'Midurethral Sling Tensioning', 'Mayo Scissor']","['Rates of mesh erosion', 'primary outcome (abnormal bladder) was a composite of persistent stress urinary incontinence (SUI), overactive bladder, and urinary retention', 'median duration of catheterization and the proportions of women experiencing urinary retention requiring sling lysis', 'Abnormal bladder outcomes', 'abnormal bladder', 'rates of mesh erosion', 'outcomes of the composite, postoperative catheterization, incontinence-related questionnaires, repeat incontinence treatment, and uroflowmetry']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205499', 'cui_str': 'Retropubic approach'}, {'cui': 'C3179501', 'cui_str': 'Mid-Urethral Slings'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C4505203', 'cui_str': 'A-Loop'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C1272733', 'cui_str': 'Mayo scissors'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0080274', 'cui_str': 'Bladder retention of urine'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0183346', 'cui_str': 'Sling'}, {'cui': 'C0024348', 'cui_str': 'Lysis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}]",506.0,0.669678,Abnormal bladder outcomes were 12.9% less frequent for women with midurethral slings tensioned by Babcock.,"[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Brennand', 'Affiliation': 'Department of Obstetrics & Gynecology, the Department of Community Health Sciences, the Division of Urology, Department of Surgery, Cumming School of Medicine, University of Calgary, Calgary, Alberta, the Department of Obstetrics & Gynecology, University of British Columbia, Vancouver, British Columbia, the Department of Obstetrics & Gynecology, University of Manitoba, Winnipeg, Manitoba, the Department of Obstetrics & Gynecology, University of Toronto, Toronto, Ontario, the Department of Obstetrics & Gynecology, University of Alberta, Edmonton, Alberta, Canada; and the Department of Obstetrics & Gynecology, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'Guosong', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Houlihan', 'Affiliation': ''}, {'ForeName': 'Dobrochna', 'Initials': 'D', 'LastName': 'Globerman', 'Affiliation': ''}, {'ForeName': 'Louise-Helene', 'Initials': 'LH', 'LastName': 'Gagnon', 'Affiliation': ''}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Birch', 'Affiliation': ''}, {'ForeName': 'Momoe', 'Initials': 'M', 'LastName': 'Hyakutake', 'Affiliation': ''}, {'ForeName': 'Kevin V', 'Initials': 'KV', 'LastName': 'Carlson', 'Affiliation': ''}, {'ForeName': 'Hanan', 'Initials': 'H', 'LastName': 'Al-Shankiti', 'Affiliation': ''}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Robert', 'Affiliation': ''}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Lazare', 'Affiliation': ''}, {'ForeName': 'Shunaha', 'Initials': 'S', 'LastName': 'Kim-Fine', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004027']
1874,32769658,Outpatient Foley Catheter for Induction of Labor in Nulliparous Women: A Randomized Controlled Trial.,"OBJECTIVE


To assess whether outpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing elective labor induction shortens the time from admission to delivery.
METHODS


We performed a randomized controlled trial of patients with singleton pregnancies undergoing elective labor induction at 39 weeks of gestation or more with a modified Bishop score less than 5. Women were randomized 1:1 to outpatient or inpatient transcervical Foley. In the outpatient group, the Foley was inserted the day before admission for scheduled induction; insertion was performed at scheduled admission in the inpatient group. The primary outcome was duration of time from admission to the labor and delivery unit to delivery. With 80% power and a two-sided α of 0.05, a sample size of 126 was estimated to detect at least a 5-hour mean difference in time from admission to delivery between groups from a baseline duration of 19±10 hours.
RESULTS


From May 2018 to October 2019, 126 women were randomized, 63 in each group. Baseline characteristics were balanced between groups, except that body mass index (31±5.4 vs 34±7.5, P=.01) and group B streptococcus colonization (31% vs 54%, P=.01) were lower in the outpatient group. The time from admission to delivery was shorter in the outpatient group (17.4±7.4 vs 21.7±9.1 hours, P<.01, mean difference 4.3 hours, 95% CI 1.3-7.2). Admissions before scheduled induction were higher in the outpatient group (22% vs 5%, relative risk [RR] 4.7, 95% CI 1.4-15.4, P<.01), as was median modified Bishop score on admission (3 vs 1, P<.01). Cesarean delivery (24% vs 32%, RR 0.8, 95% CI 0.4-1.3, P=.32) and chorioamnionitis (22% vs 13%, RR 1.8, 95% CI 0.8-3.9, P=.16) were not significantly different between groups.
CONCLUSION


In nulliparous patients undergoing elective labor induction at term, outpatient cervical ripening with a transcervical Foley catheter reduced the time from admission to delivery.
CLINCAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT03472937.",2020,"Admissions before scheduled induction were higher in the outpatient group (22% vs 5%, relative risk [RR]","['nulliparous patients undergoing elective labor induction at term, outpatient cervical ripening with a', 'patients with singleton pregnancies undergoing elective labor induction at 39 weeks of gestation or more with a modified Bishop score less than 5', 'Nulliparous Women', 'nulliparous women undergoing elective labor induction shortens the time from admission to delivery', 'From May 2018 to October 2019, 126 women were randomized, 63 in each group']","['outpatient cervical ripening with a transcervical Foley catheter', 'transcervical Foley catheter', 'Outpatient Foley Catheter', 'inpatient transcervical Foley']","['duration of time from admission to the labor and delivery unit to delivery', 'Cesarean delivery', 'relative risk [RR', 'time from admission to delivery', 'streptococcus colonization', 'chorioamnionitis']","[{'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2225498', 'cui_str': 'Bishop score'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1321138', 'cui_str': 'Labor and delivery unit'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0008495', 'cui_str': 'Chorioamnionitis'}]",126.0,0.316198,"Admissions before scheduled induction were higher in the outpatient group (22% vs 5%, relative risk [RR]","[{'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Ausbeck', 'Affiliation': ""Center for Women's Reproductive Health, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; and Tri-State Perinatology, Deaconess-The Women's Hospital, Newburgh, Indiana.""}, {'ForeName': 'Victoria C', 'Initials': 'VC', 'LastName': 'Jauk', 'Affiliation': ''}, {'ForeName': 'Yumo', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': ''}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Files', 'Affiliation': ''}, {'ForeName': 'Spencer G', 'Initials': 'SG', 'LastName': 'Kuper', 'Affiliation': ''}, {'ForeName': 'Akila', 'Initials': 'A', 'LastName': 'Subramaniam', 'Affiliation': ''}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Casey', 'Affiliation': ''}, {'ForeName': 'Jeff M', 'Initials': 'JM', 'LastName': 'Szychowski', 'Affiliation': ''}, {'ForeName': 'Lorie M', 'Initials': 'LM', 'LastName': 'Harper', 'Affiliation': ''}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Tita', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000004041']
1875,32769965,Inotuzumab ozogamicin for relapsed/refractory acute lymphoblastic leukemia: outcomes by disease burden.,"Adults with relapsed/refractory acute lymphoblastic leukemia (R/R ALL) have a poor prognosis, especially if disease burden is high. This post hoc analysis of the phase 3 INO-VATE trial examined the efficacy and safety of inotuzumab ozogamicin (InO) vs. standard of care chemotherapy (SC) among R/R ALL patients with low, moderate, or high disease burden, respectively, defined as bone marrow blasts (BMB) < 50% (n = 53 vs. 48), 50-90% (n = 79 vs. 83), and >90% (n = 30 vs. 30). Patients in the InO vs. SC arm with low, moderate, and high BMB%, respectively, had improved rates of complete remission/complete remission with incomplete hematologic recovery (74% vs. 46% [p = 0.0022], 75 vs. 27% [p < 0.0001], and 70 vs. 17% [p < 0.0001]), and improved overall survival (hazard ratio: 0.64 [p = 0.0260], 0.81 [p = 0.1109], and 0.60 [p = 0.0335]). Irrespective of BMB%, cytopenias were the most common treatment-emergent adverse events, and post-transplant veno-occlusive disease was more common with InO vs. SC. Patients with extramedullary disease or lymphoblastic lymphoma showed similar efficacy and safety outcomes. This favorable benefit-to-risk ratio of InO treatment irrespective of disease burden supports its use in challenging and high disease burden subpopulations. INO-VATE is registered at www.clinicaltrials.gov : #NCT01564784.",2020,"Irrespective of BMB%, cytopenias were the most common treatment-emergent adverse events, and post-transplant veno-occlusive disease was more common with InO vs. SC.","['relapsed/refractory acute lymphoblastic leukemia', 'Patients with extramedullary disease or lymphoblastic lymphoma', 'R/R ALL patients with low, moderate, or high disease burden, respectively, defined as bone marrow blasts (BMB)\u2009<\u200950% (n\u2009=\u200953 vs. 48), 50-90% (n\u2009=\u200979 vs. 83), and >90% (n\u2009=\u200930 vs. 30', 'Adults with relapsed/refractory acute lymphoblastic leukemia (R/R ALL']","['Inotuzumab ozogamicin', 'inotuzumab ozogamicin (InO) vs. standard of care chemotherapy (SC']","['rates of complete remission/complete remission with incomplete hematologic recovery', 'overall survival']","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0079748', 'cui_str': 'Precursor cell lymphoblastic lymphoma'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0337026', 'cui_str': 'Blast'}, {'cui': 'C0439083', 'cui_str': '>90'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1567130', 'cui_str': 'inotuzumab ozogamicin'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0996714,"Irrespective of BMB%, cytopenias were the most common treatment-emergent adverse events, and post-transplant veno-occlusive disease was more common with InO vs. SC.","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'DeAngelo', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, 02215, USA. Daniel_Deangelo@dfci.harvard.edu.'}, {'ForeName': 'Anjali S', 'Initials': 'AS', 'LastName': 'Advani', 'Affiliation': 'Cleveland Clinic Taussig Cancer Institute, Cleveland, OH, 44106, USA.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Marks', 'Affiliation': 'University Hospitals Bristol, Bristol, BS1 3NU, UK.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Stelljes', 'Affiliation': 'Universitätsklinikum Münster, 48149, Münster, Germany.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Liedtke', 'Affiliation': 'Stanford Cancer Institute, Stanford, CA, 94304, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Stock', 'Affiliation': 'University of Chicago, Chicago, IL, 60637, USA.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Gökbuget', 'Affiliation': 'Goethe University Hospital, 60596, Frankfurt, Germany.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Jabbour', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.'}, {'ForeName': 'Akil', 'Initials': 'A', 'LastName': 'Merchant', 'Affiliation': 'Cedars Sinai Medical Center, Los Angeles, CA, 90048, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Vandendries', 'Affiliation': 'Pfizer Inc, Cambridge, MA, 02139, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Neuhof', 'Affiliation': 'Pfizer Pharma GmbH, 10785, Berlin, Germany.'}, {'ForeName': 'Hagop', 'Initials': 'H', 'LastName': 'Kantarjian', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, CA, 92697, USA.'}]",Blood cancer journal,['10.1038/s41408-020-00345-8']
1876,32776722,Performance of a Community-based Noncommunicable Disease Control Program in Korea: Patients 65 Years of Age or Older.,"BACKGROUND


In Korea, the Korean Community-based Noncommunicable Disease Prevention and Control Program (KCNPC) was implemented in 2012 for the management of patients with chronic diseases. Nineteen primary care clinics, public health centers, and education and consulting centers (ECCs) participated in the implementation of this program. This study assessed the effectiveness of this chronic disease control model by comparing mortality rate and the incidence of complications between patients participating in the KCNPC program and a control group.
METHODS


Using data from the National Health Insurance Service and data from hypertension and diabetes patients registered with 19 ECCs between January 1, 2010 and December 31, 2012, hypertension and diabetes patients who had been treated at a clinic were selected. The final analysis included 252,900 patients, with the intervention group and control group having 126,450 patients each. Survival for the two groups was analyzed using the Kaplan-Meier method. Complications were analyzed using the Cox proportional hazards model.
RESULTS


The 5-year survival rate in the intervention group (0.88) was higher than that in the control group (0.86). Cox proportional hazards analysis showed that the intervention group had lower risk for mortality (0.84; 95% confidence interval [CI], 0.82-0.86) compared to the control group. Hospitalization due to complications and the proportional risk of hospitalization were also lower in the intervention group.
CONCLUSION


The KCNPC model for prevention and control of chronic disease in Korea was found to be effective for hypertension and diabetes patients. Therefore, the KCNPC will be necessary to strengthen the capabilities of local communities, primary medical institutions, and individuals for prevention and control of chronic disease. Expanding the efficient prevention and control policies of the KCNPC to a nationwide scale may be effective as has been demonstrated through limited implementation in some regions.",2020,The KCNPC model for prevention and control of chronic disease in Korea was found to be effective for hypertension and diabetes patients.,"['Korea: Patients 65 Years of Age or Older', 'patients registered with 19 ECCs between January 1, 2010 and December 31, 2012, hypertension and diabetes patients who had been treated at a clinic were selected', 'Nineteen primary care clinics, public health centers, and education and consulting centers (ECCs) participated in the implementation of this program', '252,900 patients, with the intervention group and control group having 126,450 patients each', 'patients with chronic diseases', 'Using data from the National Health Insurance Service and data from hypertension and diabetes', 'patients participating in the KCNPC program and a control group']","['Community-based Noncommunicable Disease Control Program', 'Control Program (KCNPC', 'KCNPC']","['5-year survival rate', 'Survival', 'lower risk for mortality', 'mortality rate and the incidence of complications', 'proportional risk of hospitalization']","[{'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0585825', 'cui_str': 'Patient registered'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205351', 'cui_str': 'Proportional'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",252900.0,0.0179266,The KCNPC model for prevention and control of chronic disease in Korea was found to be effective for hypertension and diabetes patients.,"[{'ForeName': 'Sun Mi', 'Initials': 'SM', 'LastName': 'Lim', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Sung Hyo', 'Initials': 'SH', 'LastName': 'Seo', 'Affiliation': 'Department of Information Statistics, Gyeongsang National University, Jinju, Korea.'}, {'ForeName': 'Ki Soo', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Preventive Medicine, College of Medicine and Institute of Health Science, Gyeongsang National University, Jinju, Korea.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Hwangbo', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Yeonok', 'Initials': 'Y', 'LastName': 'Suh', 'Affiliation': 'Department of Nursing, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Sungin', 'Initials': 'S', 'LastName': 'Ji', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Jeongmook', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Hyeonji', 'Initials': 'H', 'LastName': 'Hwang', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Jose Rene Bagani', 'Initials': 'JRB', 'LastName': 'Cruz', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea.'}, {'ForeName': 'Yoon Hyung', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Department of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan, Korea. parky@sch.ac.kr.'}]",Journal of Korean medical science,['10.3346/jkms.2020.35.e268']
1877,32777605,"The psychological impact of a nurse-led proactive self-care program on independent, non-frail community-dwelling older adults: A randomized controlled trial.","BACKGROUND


Poor mental health is common later in life and is a crucial factor in determining older adults' ability to live independently in the community. Existing nurse-led proactive self-care programs for older adults focus on physical health, since many are living with chronic diseases. Little is known about their effectiveness on the psychological outcomes of independent, non-frail community-dwelling older adults.
AIM


The aim of this study was to examine the impact of a nurse-led proactive self-care program with a health-social partnership model for community-dwelling older adults on depressive symptoms, life satisfaction, and the mental component of health-related quality of life.
DESIGN AND METHODS


This was a single-blinded, randomized controlled trial. Adults aged 60 or over who lived within the service areas and scored ≥ 18 in the Mini-Mental Status Examination were included. Data were collected using questionnaires pre- (T1), post- (T2), and three month after the intervention (T3). The program provided a comprehensive assessment, health and self-management information, and empowerment, and promoted the accessibility of community services by building a health-social partnership network in the community. Generalized Estimating Equation was used to calculate the group, time, and interaction effects. Intention-to-treat was employed as the primary analysis in this study.
RESULTS


Of the 843 potential community-dwelling older adults who were assessed for eligibility, 457 eligible participants were randomized into the intervention (n = 230) or control group (n = 227). Among them, 175 (76.0%) participants in the intervention group and 190 (83.7%) participants in the control group completed data collection at T3, 6 months after T2 at the completion of the program. The results showed a significant time effect between T1 and T2 (Wald χ2 = 25.7, p < .001) and T1 and T3 (Wald χ2 = 7.40, p = .007) in terms of the presence of depressive symptoms.
CONCLUSIONS


Interprofessional care addressing health and social needs improves the depressive symptoms among older adults dwelling in the community.",2020,"The results showed a significant time effect between T1 and T2 (Wald χ2 = 25.7, p < .001) and T1 and T3 (","['older adults', 'non-frail community-dwelling older adults', 'older adults dwelling in the community', 'community-dwelling older adults', 'frail community-dwelling older adults', '457 eligible participants', 'Adults aged 60 or over who lived within the service areas and scored ≥ 18 in the Mini-Mental Status Examination were included', '843 potential community-dwelling older adults who were assessed for eligibility']","['Existing nurse-led proactive self-care programs', 'nurse-led proactive self-care program', 'nurse-led proactive self-care program with a health-social partnership model']","['depressive symptoms, life satisfaction, and the mental component of health-related quality of life', 'depressive symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",457.0,0.0758161,"The results showed a significant time effect between T1 and T2 (Wald χ2 = 25.7, p < .001) and T1 and T3 (","[{'ForeName': 'Arkers Kwan Ching', 'Initials': 'AKC', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. Electronic address: Arkers.wong@polyu.edu.hk.'}, {'ForeName': 'Frances Kam Yuet', 'Initials': 'FKY', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. Electronic address: Frances.wong@polyu.edu.hk.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103724']
1878,32777606,Cognitive performance of patients with opioid use disorder transitioned to extended-release injectable naltrexone from buprenorphine: Post hoc analysis of exploratory results of a phase 3 randomized controlled trial.,"BACKGROUND


Opioid use disorder (OUD) is associated with cognitive dysfunction. Understanding how pharmacotherapy may affect cognition is an important treatment consideration.
METHODS


This was a hybrid residential-outpatient, randomized trial assessing transition regimens (naltrexone/buprenorphine [NTX/BUP] vs placebo-NTX/buprenorphine [PBO-N]/BUP) to extended-release naltrexone (XR-NTX) in patients with OUD seeking BUP discontinuation. Cognition was assessed at baseline, Day 22 (XR-NTX Day 14), and Day 36 (XR-NTX Day 28) using a range of measures (Brief Assessment of Cognition Symbol Coding test, Controlled Oral Word Association Task, Wechsler Memory Scale-III Spatial Span test, Continuous Performance Test, and Test of Attentional Performance). Pre-specified exploratory analyses compared treatment groups. Post hoc analyses were treatment-arm-independent analyses overall and by baseline BUP dose (<8 mg/day [low-dose] or 8 mg/day [higher-dose]).
RESULTS


Baseline cognitive measures were similar between NTX/BUP and PBO-N/BUP groups and between BUP low-dose and higher-dose groups. There were improvements in several cognitive outcomes at Day 22 and Day 36 relative to baseline for the overall population, but no differences between NTX/BUP and PBO-N/BUP treatment groups were observed. Participants entering the study on low-dose BUP showed improvements at Day 36 relative to baseline in 5 of 7 cognitive outcomes; participants entering the study on higher-dose BUP generally did not show improvements in cognitive outcomes.
CONCLUSIONS


Improvements in most cognitive domains were associated with the transition from BUP to XR-NTX, particularly in participants entering the study on low-dose (<8 mg/day) BUP. These improvements may be due to the discontinuation of BUP, the treatment with XR-NTX, or both.",2020,"There were improvements in several cognitive outcomes at Day 22 and Day 36 relative to baseline for the overall population, but no differences between NTX/BUP and PBO-N/BUP treatment groups were observed.","['patients with OUD seeking BUP discontinuation', 'patients with opioid use disorder transitioned to extended-release injectable']","['naltrexone (XR-NTX', 'naltrexone', 'naltrexone/buprenorphine [NTX/BUP', 'buprenorphine', 'placebo-NTX/buprenorphine [PBO-N]/BUP']","['cognitive outcomes', 'range of measures (Brief Assessment of Cognition Symbol Coding test, Controlled Oral Word Association Task, Wechsler Memory Scale-III Spatial Span test, Continuous Performance Test, and Test of Attentional Performance', 'Cognition', 'several cognitive outcomes', 'Cognitive performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031962', 'cui_str': 'Piperonyl Butoxide'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3827022', 'cui_str': 'Controlled Oral Word Association Test'}, {'cui': 'C0451575', 'cui_str': 'Wechsler memory scale'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]",,0.0245195,"There were improvements in several cognitive outcomes at Day 22 and Day 36 relative to baseline for the overall population, but no differences between NTX/BUP and PBO-N/BUP treatment groups were observed.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kosten', 'Affiliation': 'Baylor College of Medicine and MEDVAMC, Houston, TX, United States. Electronic address: kosten@bcm.edu.'}, {'ForeName': 'Efrat', 'Initials': 'E', 'LastName': 'Aharonovich', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center, and The New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Nangia', 'Affiliation': 'Alkermes, Inc., Waltham, MA, United States.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Zavod', 'Affiliation': 'Alkermes, Inc., Waltham, MA, United States.'}, {'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Akerman', 'Affiliation': 'Alkermes, Inc., Waltham, MA, United States.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lopez-Bresnahan', 'Affiliation': 'Alkermes, Inc., Waltham, MA, United States.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Sullivan', 'Affiliation': 'Department of Psychiatry, Columbia University Medical Center, and The New York State Psychiatric Institute, New York, NY, United States; Alkermes, Inc., Waltham, MA, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106538']
1879,32777617,Longitudinal suicide ideation trajectories in a clinical trial of brief CBT for U.S. military personnel recently discharged from psychiatric hospitalization.,"Research among adolescent samples has suggested patterns of change in suicidal ideation (SI) following psychiatric hospitalization discharge are heterogenous and predictive of subsequent suicide attempts. However, no studies have examined SI trajectories following discharge among adult samples or the effect of treatment on trajectories. We used growth mixture modeling to examine trajectories of SI among 152 active duty military personnel in a randomized controlled trial comparing brief cognitive-behavioral therapy (CBT) for suicide prevention to treatment as usual following discharge from inpatient psychiatric hospitalization for a suicide risk. Analyses of SI at baseline, 3-, 6-, and 12-months post-discharge among the full sample randomized to both conditions revealed two trajectories: rapid improvers (59.21%) and gradual improvers (40.79%). Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge. Exploratory analyses suggested that, relative to those in the treatment as usual condition, those randomized to brief CBT in both trajectories may be less likely to make a suicide attempt during the follow-up period. Results replicate and extend prior research in identifying distinct ideation trajectories following psychiatric inpatient hospitalization for suicide risk to active-duty personnel in a treatment trial and linking these trajectories to suicide attempts during follow-up.",2020,Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge.,['152 active duty military personnel'],['cognitive-behavioral therapy (CBT'],['Longitudinal suicide ideation trajectories'],"[{'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}]",152.0,0.135962,Gradual improvers were more than twice as likely to attempt suicide in the two years following discharge.,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Lee', 'Affiliation': 'National Center for PTSD, Boston, MA, United States; VA Boston Healthcare System, Boston, MA, United States; Boston University School of Medicine, Boston, MA, United States. Electronic address: daniel.lee14@va.gov.'}, {'ForeName': 'Craig J', 'Initials': 'CJ', 'LastName': 'Bryan', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, UT, United States; University of Utah, Salt Lake City, UT, United States.'}, {'ForeName': 'M David', 'Initials': 'MD', 'LastName': 'Rudd', 'Affiliation': 'National Center for Veterans Studies, Salt Lake City, UT, United States; University of Memphis, Memphis, TN, United States.'}]",Psychiatry research,['10.1016/j.psychres.2020.113335']
1880,32777664,Digital application developed to evaluate functional results following robot-assisted radical prostatectomy: App for prostate cancer.,"INTRODUCTION


Mobile applications (""apps"") developed for smartphones and tablets are increasingly used in healthcare, allowing remote patient support or promoting self-health care. Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy. The main complications following surgery are urinary incontinence and erectile dysfunction. However, the exact numbers related to these morbidities are often missing due to brief interviews during consultations in the medical office. Therefore, the aim of this study was to create an app to determine whether response rates to pre- and post-surgical PC questionnaires will increase.
METHODS


The app was built using the IONIC framework system and provided to patients through a prospective randomized study. We included 100 patients divided into two groups: 1. first group used the app (n = 50); and 2. second group responded via validated printed questionnaires (control group) (n = 50). All patients received discharge counseling to respond to the questionnaires 1, 3, 6 and 12 months after the procedure. The app group received verbal guidance on how monitoring would occur, received an SMS containing a username and password providing access to the system and received reminder alerts to respond to the questionnaires.
RESULTS


The new app is called UroHealth and is available for download in the Apple App Store or at www.urohealth.com.br. When we evaluated the response rates, we found that 42.9% of the patients answered the preoperative questionnaire in the app group, while 16% responded in the control group (p = 0.003). By the end of the follow-up, we found that 24.5% of the patients answered the questionnaire in the app group, while 4% responded in the control group (p = 0.003).
CONCLUSION


This app enabled almost 6 times more patients to answer long-term follow-up questions after surgical procedures, providing high-quality information regarding morbidity related to treatment. Although our initial results indicate that this app may become a useful tool in obtaining more frequent and realistic answers, thus helping to improve surgical techniques, other ways of reaching the patient should be tested to achieve higher response rates.",2020,"Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy.",['100 patients divided into two groups: 1. first group used the app (n\xa0=\xa050); and'],"['robot-assisted radical prostatectomy', 'SMS containing a username and password providing access to the system and received reminder alerts to respond to the questionnaires', 'verbal guidance', '2. second group responded via validated printed questionnaires (control group', 'discharge counseling']","['response rates', 'preoperative questionnaire', 'urinary incontinence and erectile dysfunction']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}]",100.0,0.0209113,"Prostate cancer (PC) screening allows for early-stage PC diagnosis, resulting in high rates of curative procedures such as radical prostatectomy.","[{'ForeName': 'Leandro F', 'Initials': 'LF', 'LastName': 'Faria', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: lfaria83@gmail.com.'}, {'ForeName': 'Sabrina T', 'Initials': 'ST', 'LastName': 'Reis', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil; Faculdade Atenas - Campus Passos, Minas Gerais, 37900-380, Brazil. Electronic address: sasareis@gmail.com.'}, {'ForeName': 'Katia R', 'Initials': 'KR', 'LastName': 'Leite', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: katiaramos@usp.br.'}, {'ForeName': 'José Arnaldo Shiomi', 'Initials': 'JAS', 'LastName': 'da Cruz', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: arnadolshiomi@yahoo.com.br.'}, {'ForeName': 'Ruan', 'Initials': 'R', 'LastName': 'Pimenta', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: ruanpimenta22@gmail.com.'}, {'ForeName': 'Nayara I', 'Initials': 'NI', 'LastName': 'Viana', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: nayara_viana_2@hotmail.com.'}, {'ForeName': 'Gabriela Q', 'Initials': 'GQ', 'LastName': 'Amaral', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: gabriela.queiroz.amaral@gmail.com.'}, {'ForeName': 'Gabriel A G D', 'Initials': 'GAGD', 'LastName': 'Santos', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: arantes_gabriel@hotmail.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ilias', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: daniel.ilias22@gmail.com.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fakhouri', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: ffakhouri@gmail.com.'}, {'ForeName': 'Geraldo', 'Initials': 'G', 'LastName': 'Xavier', 'Affiliation': 'Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: geraldoxaviermed@gmail.com.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Srougi', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil. Electronic address: srougi@uol.com.br.'}, {'ForeName': 'Carlo Camargo', 'Initials': 'CC', 'LastName': 'Passerotti', 'Affiliation': 'Laboratory of Medical Investigation (LIM55), Urology Department, Faculdade de Medicina da Universidade de São Paulo (FMUSP), São Paulo 01246-903, Brazil; Center for Robotic Surgery, Hospital Alemão Oswaldo Cruz, São Paulo 01327-001, Brazil. Electronic address: carlopasserotti@hotmail.com.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105683']
1881,32777692,Health-related quality of life and opioid use disorder pharmacotherapy: A secondary analysis of a clinical trial.,"OBJECTIVE


To examine the health-related quality-of-life (HRQoL) of persons with opioid use disorder (OUD) seeking treatment in an inpatient detoxification or short-term residential setting; continuing treatment as outpatients.
METHODS


We conducted a secondary analysis of data from a clinical trial (N = 508) where participants were randomized to extended-release naltrexone or buprenorphine-naloxone for the prevention of opioid relapse. We used a generalized structural equation regression mixture model to identify associations of HRQoL (EQ-5D) trajectories, including latent characteristics, over the 24-week trial and 36-week follow-up period, among participants who reported HRQoL beyond baseline. This novel framework accounted for baseline and time-varying characteristics, while simultaneously identifying latent classes.
RESULTS


We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %). The pharmacotherapy responsive subpopulation was characterized by a shortterm HRQoL improvement and then stable HRQoL over time, and by a positive association between HRQoL and receiving pharmacotherapy in the past 30 days. The characteristic sensitive subpopulation was characterized by an initial improvement in HRQoL with a gradual decline over time, and no significant HRQoL response to pharmacotherapy. HRQoL changes over time in this subpopulation were more influenced by baseline demographic, socioeconomic, and psychosocial characteristics.
CONCLUSION


Our findings suggest that while HRQoL may be improved and sustained through targeted efforts to promote use of pharmacotherapy for many persons with OUD, an identifiable subpopulation may require additional services that address socioeconomic and psychosocial issues to achieve HRQoL benefits. Our analysis provides insight for improving individualized care for persons with opioid use disorder seeking treatment.",2020,"We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %).","['persons with opioid use disorder seeking treatment', 'persons with opioid use disorder (OUD', 'participants who reported HRQoL beyond baseline']","['naltrexone or buprenorphine-naloxone', 'opioid use disorder pharmacotherapy']",['health-related quality-of-life (HRQoL'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",508.0,0.0789426,"We identified two subpopulations: HRQoL ""pharmacotherapy responsive"" (82.3 %) and HRQoL ""characteristic sensitive"" (17.7 %).","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Jalali', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA. Electronic address: alj4004@med.cornell.edu.'}, {'ForeName': 'Danielle A', 'Initials': 'DA', 'LastName': 'Ryan', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Jeng', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'McCollister', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Jared A', 'Initials': 'JA', 'LastName': 'Leff', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Lee', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'New York State Psychiatric Institute, Columbia University Medical Center, New York, NY USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Novo', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University Grossman School of Medicine, New York, NY, USA.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medical College, New York, NY, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108221']
1882,32772733,"Serum Perfluoroalkyl Substances, Vaccine Responses, and Morbidity in a Cohort of Guinea-Bissau Children.","BACKGROUND


Perfluoroalkyl substances (PFAS) are a group of widely used persistent chemicals with suspected immunotoxic effects.
OBJECTIVES


The present study aimed to examine the association between infant PFAS exposure and antibody responses to measles vaccination as well as morbidity in a low-income country.
METHODS


In a randomized controlled trial, children from Guinea-Bissau, West Africa, were followed from inclusion (4-7 months of age) through 2 years of age. Half the children received two measles vaccinations (at inclusion and at 9 months of age), and the other half received only one (at 9 months of age). In a subset of 237 children, six PFAS were quantified in serum at inclusion, and measles antibody concentrations were assessed at inclusion and at approximately 9 months and 2 years of age. At inclusion and at the 9-month visit, mothers were interviewed about infant morbidity.
RESULTS


All but one child had detectable serum concentrations of all six PFAS, although levels were lower than seen elsewhere. A doubling in perfluorooctane sulfonic acid (PFOS) and perfluorodecanoic acid (PFDA) were associated with 21% (95% CI: 2, 37%) and 25% (95% CI: 1, 43%), respectively, lower measles antibody concentrations at the 9-month visit among the children who had received a measles vaccine at inclusion. Elevated serum PFAS concentrations were also associated with reduced prevaccination measles antibody concentrations and increased morbidity.
DISCUSSION


The present study documents that PFAS exposure has reached West Africa and that infants show PFAS-associated increases in morbidity and decreases in measles-specific antibody concentrations before and after vaccination. These findings support the evidence on PFAS immunotoxicity at comparatively low serum concentrations. https://doi.org/10.1289/EHP6517.",2020,"Elevated serum PFAS concentrations were also associated with reduced prevaccination measles antibody concentrations and increased morbidity.
","['children from Guinea-Bissau, West Africa, were followed from inclusion (4-7 months of age) through 2 years of age']","['Perfluoroalkyl substances (PFAS', 'https://doi.org/10.1289/EHP6517']","['Elevated serum PFAS concentrations', 'PFAS immunotoxicity', 'morbidity', 'Serum Perfluoroalkyl Substances, Vaccine Responses, and Morbidity', 'perfluorooctane sulfonic acid (PFOS) and perfluorodecanoic acid (PFDA']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018387', 'cui_str': 'Guinea-Bissau'}, {'cui': 'C0001747', 'cui_str': 'Western Africa'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0439861', 'cui_str': 'Substance'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0457929', 'cui_str': 'Substance concentration'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0172926', 'cui_str': 'perfluorooctane sulfonic acid'}, {'cui': 'C0070396', 'cui_str': 'perfluorodecanoic acid'}]",237.0,0.111341,"Elevated serum PFAS concentrations were also associated with reduced prevaccination measles antibody concentrations and increased morbidity.
","[{'ForeName': 'Clara Amalie Gade', 'Initials': 'CAG', 'LastName': 'Timmermann', 'Affiliation': 'Research Unit of Environmental Medicine, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Kristoffer Jarlov', 'Initials': 'KJ', 'LastName': 'Jensen', 'Affiliation': 'Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Flemming', 'Initials': 'F', 'LastName': 'Nielsen', 'Affiliation': 'Research Unit of Environmental Medicine, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Esben', 'Initials': 'E', 'LastName': 'Budtz-Jørgensen', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'van der Klis', 'Affiliation': 'Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Christine Stabell', 'Initials': 'CS', 'LastName': 'Benn', 'Affiliation': 'Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Grandjean', 'Affiliation': 'Research Unit of Environmental Medicine, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Ane Bærent', 'Initials': 'AB', 'LastName': 'Fisker', 'Affiliation': 'Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark.'}]",Environmental health perspectives,['10.1289/EHP6517']
1883,32768569,The effect of conservative oxygen therapy on systemic biomarkers of oxidative stress in critically ill patients.,"BACKGROUND


Supplemental oxygen is delivered to critically ill patients who require mechanical ventilation. Oxidative stress is a potential complication of oxygen therapy, resulting in damage to essential biomolecules such as proteins, lipids, and nucleic acids. Whether plasma levels of oxidative stress biomarkers vary based on how liberally oxygen therapy is applied during mechanical ventilation is unknown.
METHODS


We carried out an oxidative stress substudy nested within a large multi-centre randomized controlled trial in which critically ill adults were randomized to receive either conservative oxygen therapy or standard oxygen therapy. Blood samples were collected at enrolment, and daily thereafter for up to three days. The antioxidant ascorbate (vitamin C) was assessed using HPLC with electrochemical detection and protein oxidation using a sensitive protein carbonyl ELISA. We also assessed whether critically ill patients with different disease states exhibited varying levels of oxidative stress biomarkers.
RESULTS


A total of 125 patients were included. Mean ascorbate concentrations decreased over time (from 25 ± 9 μmol/L to 14 ± 2 μmol/L, p < 0.001), however, there was no significant difference between the conservative oxygen group and standard care (p = 0.2), despite a significantly lower partial pressure of oxygen (PaO 2 ) in the conservative oxygen group (p = 0.03). Protein carbonyl concentrations increased over time (from 208 ± 30 μmol/L to 249 ± 29 μmol/L; p = 0.016), however, there was no significant difference between the conservative and standard oxygen groups (p = 0.3). Patients with sepsis had significantly higher protein carbonyl concentrations than the other critically ill patients (293 ± 92 μmol/L vs 184 ± 24 μmol/L, p = 0.03). Within the septic subgroup, there were no significant differences in protein carbonyl concentrations between the two interventions (p = 0.4).
CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy. Patients with sepsis exhibited elevated protein carbonyls compared with the other critically ill patients implying increased oxidative stress in this patient subgroup.",2020,"CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy.","['critically ill adults', 'critically ill patients', 'critically ill ventilated patients', 'critically ill patients with different disease states exhibited varying levels of oxidative stress biomarkers', 'A total of 125 patients were included', 'critically ill patients who require mechanical ventilation']","['conservative oxygen therapy', 'antioxidant ascorbate (vitamin C', 'Conservative oxygen therapy', 'standard oxygen therapy', 'conservative oxygen therapy or standard oxygen therapy']","['Mean ascorbate concentrations', 'systemic biomarkers of oxidative stress', 'oxidative stress', 'Blood samples', 'protein carbonyl concentrations', 'Protein carbonyl concentrations', 'systemic markers of oxidative stress', 'partial pressure of oxygen (PaO 2 ']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178487', 'cui_str': 'Ascorbate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}]",125.0,0.329893,"CONCLUSIONS


Conservative oxygen therapy does not alter systemic markers of oxidative stress in critically ill ventilated patients compared with standard oxygen therapy.","[{'ForeName': 'Anitra C', 'Initials': 'AC', 'LastName': 'Carr', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand. Electronic address: anitra.carr@otago.ac.nz.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Spencer', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hunt', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Judd', 'Affiliation': 'Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mehrtens', 'Affiliation': 'Christchurch Hospital Intensive Care Unit, Christchurch, New Zealand.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Parker', 'Affiliation': 'Christchurch Hospital Intensive Care Unit, Christchurch, New Zealand.'}, {'ForeName': 'Zoe', 'Initials': 'Z', 'LastName': 'Stockwell', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Gale', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Beaumont', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Simran', 'Initials': 'S', 'LastName': 'Kaur', 'Affiliation': 'Centre for Postgraduate Nursing Studies, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': 'Intensive and Critical Care Unit, Flinders Medical Centre, Adelaide, Australia; College of Medicine and Public Health, Flinders University, Adelaide, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand; Wellington Hospital Intensive Care Unit, Wellington, New Zealand.'}]",Free radical biology & medicine,['10.1016/j.freeradbiomed.2020.06.018']
1884,32769842,Lipid Analysis on Block Copolymer-containing Packaging Solution and Lens Care Regimens: A Randomized Clinical Trial.,"SIGNIFICANCE


Lotrafilcon B lenses packaged in and cared for with block copolymer-containing (polyoxyethylene-polyoxybutylene; EOBO) lens care solutions resulted in lower cholesterol extraction than each of the habitual silicone hydrogel lens/multipurpose solution (MPS) regimens tested.
PURPOSE


This study aimed to compare the extracted cholesterol of lotrafilcon B lenses packaged in and cared for with EOBO-containing lens care solutions with the extracted cholesterol of habitual silicone hydrogel lenses cared for with MPS not containing EOBO.
METHODS


In this prospective, randomized, observer-masked parallel study, habitual wearers of senofilcon C, senofilcon A, comfilcon A, and samfilcon A contact lenses using a non-EOBO MPS were randomized 1:1 to lotrafilcon B lenses packaged in and cared for with EOBO-containing solutions or to their habitual lenses and MPS. Subjects randomized to lotrafilcon B were further randomized to one of two EOBO-containing lens care solutions, OPTI-FREE PUREMOIST or CLEAR CARE PLUS with HydraGlyde (Alcon Laboratories, Inc., Fort Worth, TX). A subset of right eye lenses was collected after wear, and total cholesterol was extracted and measured using a fluorometric enzymatic assay.
RESULTS


Of 143 lenses analyzed, 95 were from subjects randomized to their habitual lenses/MPS and 48 to lotrafilcon B + EOBO lenses plus CLEAR CARE PLUS with HydraGlyde or OPTI-FREE PUREMOIST. The mean amounts of cholesterol extracted from lotrafilcon B + EOBO lenses cared for with CLEAR CARE PLUS with HydraGlyde (0.28 ± 0.18 μg/lens) and OPTI-FREE PUREMOIST (0.28 ± 0.48 μg/lens) were significantly lower than those extracted from senofilcon C (4.18 ± 3.25 μg/lens), senofilcon A (2.19 ± 2.69 μg/lens), comfilcon A (2.17 ± 1.47 μg/lens), and samfilcon A (2.07 ± 1.48 μg/lens) lenses used with MPS (P < .0001 each).
CONCLUSIONS


Cholesterol sorption was significantly lower in wearers of lotrafilcon B lenses cared for with polyoxyethylene-polyoxybutylene-containing lens care solutions than in users of habitual silicone hydrogel lenses cared for with non-polyoxyethylene-polyoxybutylene MPS.",2020,"CONCLUSIONS


Cholesterol sorption was significantly lower in wearers of lotrafilcon B lenses cared for with polyoxyethylene-polyoxybutylene-containing lens care solutions than in users of habitual silicone hydrogel lenses cared for with non-polyoxyethylene-polyoxybutylene MPS.","['habitual silicone hydrogel lenses cared for with MPS not containing EOBO', 'Of 143 lenses analyzed', 'habitual wearers of senofilcon C, senofilcon A, comfilcon A, and samfilcon A contact lenses using a non-EOBO MPS']","['polyoxyethylene-polyoxybutylene-containing lens care solutions', 'lotrafilcon B lenses packaged in and cared for with EOBO-containing solutions or to their habitual lenses and MPS', 'EOBO-containing lens care solutions, OPTI-FREE PUREMOIST or CLEAR CARE PLUS with HydraGlyde', 'habitual lenses/MPS and 48 to lotrafilcon B + EOBO lenses plus CLEAR CARE PLUS with HydraGlyde or OPTI-FREE']",[],"[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0037114', 'cui_str': 'Silicones'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C2002497', 'cui_str': 'senofilcon A'}, {'cui': 'C2715682', 'cui_str': 'comfilcon A'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C2001571', 'cui_str': 'lotrafilcon B'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}]",[],,0.0694105,"CONCLUSIONS


Cholesterol sorption was significantly lower in wearers of lotrafilcon B lenses cared for with polyoxyethylene-polyoxybutylene-containing lens care solutions than in users of habitual silicone hydrogel lenses cared for with non-polyoxyethylene-polyoxybutylene MPS.","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Shows', 'Affiliation': 'Alcon Research, LLC, Fort Worth, Texas.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Redfern', 'Affiliation': 'College of Optometry, University of Houston, Houston, Texas.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Sickenberger', 'Affiliation': 'Jenvis Research, Ernst-Abbe University of Applied Sciences, Jena, Germany.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Fogt', 'Affiliation': 'The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Schulze', 'Affiliation': 'University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lievens', 'Affiliation': 'Southern College of Optometry, Memphis, Tennessee.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Szczotka-Flynn', 'Affiliation': 'University Hospitals of Cleveland Eye Institute, Cleveland, Ohio.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schwarz', 'Affiliation': 'Private Practice, Hildesheim, Germany.'}, {'ForeName': 'Anna A', 'Initials': 'AA', 'LastName': 'Tichenor', 'Affiliation': 'Indiana University, Bloomington, Indiana.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Marx', 'Affiliation': 'Jenvis Research, Ernst-Abbe University of Applied Sciences, Jena, Germany.'}, {'ForeName': 'Jessie M', 'Initials': 'JM', 'LastName': 'Lemp-Hull', 'Affiliation': 'Alcon Research, LLC, Fort Worth, Texas.'}]",Optometry and vision science : official publication of the American Academy of Optometry,['10.1097/OPX.0000000000001553']
1885,32769863,Long-term beneficial effects of an online mind-body training program on stress and psychological outcomes in female healthcare providers: A non-randomized controlled study.,"Mind-body training (MBT) programs are effective interventions for relieving stress and improving psychological capabilities. To expand our previous study which demonstrated the short-term effects of an 8-week online MBT program, the present study investigated whether those short-term effects persist up to a month after the end of the intervention.Among previous participants, 56 (64%) participated in this follow-up study, 25 in the MBT group and 31 in the control group. Outcome measures included the stress response, emotional intelligence, resilience, coping strategies, positive and negative affect, and anger expression of both groups at baseline, at 8 weeks (right after the training or waiting period), and at 12 weeks (a month after the training or waiting period).The MBT group showed a greater decrease in stress response at 8 weeks, and this reduction remained a month after the end of the intervention. The effect of MBT on resilience and effective coping strategies was also significant at 8 weeks and remained constant a month later. However, the improvement to emotional intelligence and negative affect did not persist a month after training.These findings suggest that the beneficial short-term effects of MBT may last beyond the training period even without continuous practice, but the retention of these benefits seems to depend on the outcome variables. Through a convenient, affordable, and easily accessible online format, MBT may provide cost-effective solutions for employees at worksites.",2020,The effect of MBT on resilience and effective coping strategies was also significant at 8 weeks and remained constant a month later.,['female healthcare providers'],"['MBT', 'online mind-body training program', 'Mind-body training']","['emotional intelligence', 'stress and psychological outcomes', 'stress response, emotional intelligence, resilience, coping strategies, positive and negative affect, and anger expression', 'resilience and effective coping strategies', 'stress response']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C1510539', 'cui_str': 'Emotional Intelligence'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C2364069', 'cui_str': 'Able to cope'}]",,0.0207628,The effect of MBT on resilience and effective coping strategies was also significant at 8 weeks and remained constant a month later.,"[{'ForeName': 'Dasom', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Emotional Information and Communication Technology Association.'}, {'ForeName': 'Won Joon', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Psychiatry, Kangdong Sacred Heart Hospital.'}, {'ForeName': 'Soo-Hee', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Psychiatry, Seoul National University Hospital.'}, {'ForeName': 'Joon-Hwan', 'Initials': 'JH', 'LastName': 'Jang', 'Affiliation': 'Department of Psychiatry, Seoul National University Hospital.'}, {'ForeName': 'Do-Hyung', 'Initials': 'DH', 'LastName': 'Kang', 'Affiliation': 'Emotional Information and Communication Technology Association.'}]",Medicine,['10.1097/MD.0000000000021027']
1886,32768874,Intermittent Motivational Interviewing and Transdiagnostic CBT for Anxiety: A Randomized Controlled Trial.,"Recent meta-analytic findings suggest that Motivational Interviewing (MI) used as an adjunct to Cognitive Behavior Therapy (CBT) for anxiety disorders improves overall treatment outcomes (Marker & Norton, 2018). However, when used as a prelude to CBT, MI significantly increases the length of treatment and numerous studies note that the effectiveness of pre-treatment MI subsides over time. The current study adapted an already established 12-session transdiagnostic CBT protocol (tCBT, Norton, 2012) to include one hour of MI spread across four sessions of tCBT (sessions 1, 3, 8, and 10) at 15 minutes each, with the option of including additional MI if resistance arose in therapy. Thirty-six treatment seeking adults with principal anxiety disorder diagnosis were randomly assigned to receive intermittent MI and tCBT (iMI + tCBT) or tCBT and psychoeducation. Results indicated that the iMI + tCBT condition significantly outperformed the tCBT condition on several primary outcome variables. While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning. These effects were not moderated by baseline motivation or baseline ambivalence. The study also found that the iMI + tCBT condition showed significantly greater improvement to comorbid conditions and greater reduction in self-report depressive symptoms. The inclusion of MI did not impact participant drop out. This study provides further support for integrating MI and tCBT and highlights that even small doses of MI can improve treatment outcomes, without increasing length of usual therapy. Limitations and future research options are also discussed.",2020,"While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning.","['for Anxiety', 'Thirty-six treatment seeking adults with principal anxiety disorder diagnosis']","['Intermittent Motivational Interviewing and Transdiagnostic CBT', 'Cognitive Behavior Therapy (CBT', 'Motivational Interviewing (MI', 'intermittent MI and tCBT (iMI\u202f+\u202ftCBT) or tCBT and psychoeducation']","['self-report depressive symptoms', ""composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning""]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0340305', 'cui_str': 'Myocardial Infarction, Inferior Wall'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]",36.0,0.0207886,"While no significant difference was found between the two groups on clinician rated scores of participant principal anxiety disorder, differences were found on a composite index of participants' self-report measures of symptom improvement, and on clinician rated scores of global psychiatric functioning.","[{'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Marker', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Bronte E', 'Initials': 'BE', 'LastName': 'Corbett', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Sean P A', 'Initials': 'SPA', 'LastName': 'Drummond', 'Affiliation': 'Monash University, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Norton', 'Affiliation': 'Monash University, Australia. Electronic address: Peter.Norton@monash.edu.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102276']
1887,32768992,Cannabis use in patients 3 months after ceasing nabiximols for the treatment of cannabis dependence: Results from a placebo-controlled randomised trial.,"INTRODUCTION AND AIMS


Previous studies suggest cannabinoid agonist treatment is effective in reducing cannabis use in dependent treatment seekers, however few studies have reported on post-treatment outcomes. We examine cannabis use outcomes 12 weeks after cessation of treatment from a randomised placebo-controlled trial of nabiximols for the treatment of cannabis dependence.
METHOD


128 participants received either nabiximols (n = 61) or placebo (n = 67) for 12 weeks, in combination with psychosocial interventions. Self-reported number of days of cannabis use in the previous 28 days was measured at baseline, 4, 8, and 12 weeks (end of treatment) and again at 24 weeks (3 months after treatment ceased). Urinalysis was used to confirm self-report data at Week 24 interview.
RESULTS


A factorial mixed-effects model for repeated measures regression revealed that the nabiximols group used cannabis on 6.8 fewer days in the previous 28 days at week 12 (end of treatment) than the placebo group (p = 0.002, CI: 2.1,11.4), and 6.7 fewer days in the previous 28 days at the week-24 follow-up than the placebo group (p = 0.006, CI: 1.4,12.1). A significantly higher proportion of the nabiximols group (14/61; 23 %) than the placebo group (6/67; 9%) reported abstinence from cannabis in the previous 28 days at the week-24 research interview OR=3.0, CI: 1.1, 9.1; p=0.035, NNT=8, CI: 4, 71).
DISCUSSIONS AND CONCLUSIONS


The benefits of treatment incorporating nabiximols with psychosocial interventions in reducing cannabis use appears to persist for up to 3 months after the cessation of treatment. A stepped care model of treatment is proposed.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12616000103460) https://www.anzctr.org.au.",2020,"A significantly higher proportion of the nabiximols group (14/61; 23 %) than the placebo group (6/67; 9%) reported abstinence from cannabis in the previous 28 days at the week-24 research interview OR=3.0, CI: 1.1, 9.1; p=0.035, NNT=8, CI: 4, 71).
","['patients 3 months after ceasing nabiximols for the treatment of cannabis dependence', '128 participants received either nabiximols (n = 61) or']","['nabiximols with psychosocial interventions', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2347556', 'cui_str': 'nabiximols'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006870', 'cui_str': 'Cannabis dependence'}]","[{'cui': 'C2347556', 'cui_str': 'nabiximols'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],128.0,0.260502,"A significantly higher proportion of the nabiximols group (14/61; 23 %) than the placebo group (6/67; 9%) reported abstinence from cannabis in the previous 28 days at the week-24 research interview OR=3.0, CI: 1.1, 9.1; p=0.035, NNT=8, CI: 4, 71).
","[{'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, NSW, Australia; Division Addiction Medicine, Faculty Medicine and Health, University of Sydney, NSW, Australia; NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia. Electronic address: Nicholas.lintzeris@health.nsw.gov.au.'}, {'ForeName': 'Llewellyn', 'Initials': 'L', 'LastName': 'Mills', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, NSW, Australia; Division Addiction Medicine, Faculty Medicine and Health, University of Sydney, NSW, Australia; NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Dunlop', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia; Drug and Alcohol Services, Hunter New England Local Health District, NSW, Australia; Priority Research Centre for Brain and Mental Health, School of Medicine and Public Health, University of Newcastle, NSW, Australia.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Copeland', 'Affiliation': 'University of New South Wales, NSW, Australia.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Mcgregor', 'Affiliation': 'Lambert Initiative Cannabinoid Therapeutics, University of Sydney, NSW, Australia.'}, {'ForeName': 'Raimondo', 'Initials': 'R', 'LastName': 'Bruno', 'Affiliation': 'University of Tasmania, TAS, Australia.'}, {'ForeName': 'Adrienne', 'Initials': 'A', 'LastName': 'Kirby', 'Affiliation': 'National Health and Medical Research Council, Clinical Trials Centre, Faculty Medicine and Public Health, University of Sydney, NSW, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Montebello', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, NSW, Australia; Division Addiction Medicine, Faculty Medicine and Health, University of Sydney, NSW, Australia; NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia; University of New South Wales, NSW, Australia.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia; Drug and Alcohol Services, Hunter New England Local Health District, NSW, Australia.'}, {'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Jefferies', 'Affiliation': 'NSW Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Australia; Drug Health, Western Sydney Local Health District, NSW, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kevin', 'Affiliation': 'Lambert Initiative Cannabinoid Therapeutics, University of Sydney, NSW, Australia.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Drug and Alcohol Services, South East Sydney Local Health District, NSW, Australia; Division Addiction Medicine, Faculty Medicine and Health, University of Sydney, NSW, Australia; National Health and Medical Research Council, Clinical Trials Centre, Faculty Medicine and Public Health, University of Sydney, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108220']
1888,32772395,A parallel 3-group randomised clinical trial comparing different implant treatment options for the edentulous mandible: 1-year effects on dental patient-reported outcomes and chewing function.,"OBJECTIVE


This parallel three-group randomised clinical trial compared the 1-year changes in dental patient-reported outcomes and chewing function associated with three treatment strategies for the edentulous mandible: single-implant (G-I; n = 11) or two-implant overdentures (G-II; n = 13), and fixed 4-implant complete denture (G-III; n = 13).
METHODS


Complete denture (CD) treatment was provided to all participants and after an adaptation period, they were randomly assigned to one of the three study groups. Implants (Neodent TI Cortical, Brazil) were inserted using single-stage surgery and conventional loading. The mandibular dentures were incorporated into implants using specific retention systems and procedures according to the treatment group: O'ring/ball attachments for G-I and GII, and mini-conical abutments for G-III. Patients were assessed at baseline (CD stage) and up to 1-year after implant-retained prosthodontic treatment. Treatment outcomes included oral health-related quality of life (OHIP-Edent), satisfaction with the dentures and chewing function using a mixing ability test. Data analyses included pairwise comparison tests, estimates of effect sizes and regression analysis using Generalized Estimating Equations.
RESULTS


Results showed improvement in patient-reported outcomes (lower OHIP-Edent scores and higher satisfaction) and chewing function, compared to baseline. No significant between-group differences were found, although effect sizes were lower for G-III.
CONCLUSIONS


All treatments improved the assessed outcomes after transition from the baseline condition. Findings suggest that simplified implant treatments for edentulous patients result in favourable outcomes and may be considered as suitable alternatives to more complex interventions.",2020,"Treatment outcomes included oral health-related quality of life (OHIP-Edent), satisfaction with the dentures, and chewing function using a mixing ability test.","['Complete denture (CD) treatment was provided to all participants and after an adaptation period', 'edentulous patients']",['implant (G-I; n=11) or two-implant overdentures'],"['oral health-related quality of life (OHIP-Edent), satisfaction with the dentures, and chewing function using a mixing ability test', 'patient-reported outcomes (lower OHIP-Edent scores and higher satisfaction) and chewing function']","[{'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}]",,0.0799054,"Treatment outcomes included oral health-related quality of life (OHIP-Edent), satisfaction with the dentures, and chewing function using a mixing ability test.","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hartmann', 'Affiliation': 'Federal University of Goias, Goiania, Brazil.'}, {'ForeName': 'Ana Clara Freitas de Menezes', 'Initials': 'ACFM', 'LastName': 'Bandeira', 'Affiliation': 'Federal University of Goias, Goiania, Brazil.'}, {'ForeName': 'Sara Cristina de', 'Initials': 'SC', 'LastName': 'Araújo', 'Affiliation': 'Federal University of Goias, Goiania, Brazil.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Brägger', 'Affiliation': 'Department of Reconstructive Dentistry, School of Dental Medicine of the University of Bern, Bern, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schimmel', 'Affiliation': 'Department of Reconstructive Dentistry, School of Dental Medicine of the University of Bern, Bern, Switzerland.'}, {'ForeName': 'Cláudio Rodrigues', 'Initials': 'CR', 'LastName': 'Leles', 'Affiliation': 'Federal University of Goias, Goiania, Brazil.'}]",Journal of oral rehabilitation,['10.1111/joor.13070']
1889,32771106,"Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial.","BACKGROUND


Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. The use of immediate surgical fixation to manage this type of fracture has increased, despite insufficient evidence of improved outcomes over non-surgical management. The SWIFFT trial compared the clinical effectiveness of surgical fixation with cast immobilisation and early fixation of fractures that fail to unite in adults with scaphoid waist fractures displaced by 2 mm or less.
METHODS


This pragmatic, parallel-group, multicentre, open-label, two-arm, randomised superiority trial included adults (aged 16 years or older) who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear bicortical fracture of the scaphoid waist on radiographs. An independent remote randomisation service used a computer-generated allocation sequence with randomly varying block sizes to randomly assign participants (1:1) to receive either early surgical fixation (surgery group) or below-elbow cast immobilisation followed by immediate fixation if non-union of the fracture was confirmed (cast immobilisation group). Randomisation was stratified by whether or not there was displacement of either a step or a gap of 1-2 mm inclusive on any radiographic view. The primary outcome was the total patient-rated wrist evaluation (PRWE) score at 52 weeks after randomisation, and it was analysed on an available case intention-to-treat basis. This trial is registered with the ISRCTN registry, ISRCTN67901257, and is no longer recruiting, but long-term follow-up is ongoing.
FINDINGS


Between July 23, 2013, and July 26, 2016, 439 (42%) of 1047 assessed patients (mean age 33 years; 363 [83%] men) were randomly assigned to the surgery group (n=219) or to the cast immobilisation group (n=220). Of these, 408 (93%) participants were included in the primary analysis (203 participants in the surgery group and 205 participants in the cast immobilisation group). 16 participants in the surgery group and 15 participants in the cast immobilisation group were excluded because of either withdrawal, no response, or no follow-up data at 6, 12, 26, or 52 weeks. There was no significant difference in mean PRWE scores at 52 weeks between the surgery group (adjusted mean 11·9 [95% CI 9·2-14·5]) and the cast immobilisation group (14·0 [11·3 to 16·6]; adjusted mean difference -2·1 [95% CI -5·8 to 1·6], p=0·27). More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]). The number of participants who had a medical complication was similar between the two groups (four [2%] in the surgery group and five [2%] in the cast immobilisation group).
INTERPRETATION


Adult patients with scaphoid waist fractures displaced by 2 mm or less should have initial cast immobilisation, and any suspected non-unions should be confirmed and immediately fixed with surgery. This treatment strategy will help to avoid the risks of surgery and mostly limit the use of surgery to fixing fractures that fail to unite.
FUNDING


National Institute for Health Research Health Technology Assessment Programme.",2020,"More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]).","['adults with scaphoid waist fractures displaced by 2 mm or less', '408 (93%) participants were included in the primary analysis (203 participants in the surgery group and 205 participants in the cast immobilisation group', 'Between July 23, 2013, and July 26, 2016, 439 (42%) of 1047 assessed patients (mean age 33 years; 363 [83%] men', 'young men', 'Adult patients with scaphoid waist fractures displaced by 2 mm or less should have initial cast immobilisation, and any suspected non-unions should be confirmed and immediately fixed with surgery', 'adults (aged 16 years or older) who presented to orthopaedic departments of 31 hospitals in England and Wales with a clear bicortical fracture of the scaphoid waist on radiographs', 'adults with a bicortical fracture of the scaphoid waist (SWIFFT', '16 participants in the surgery group and 15 participants in the cast immobilisation group were excluded because of either withdrawal, no response, or no follow-up data at 6, 12, 26, or 52 weeks']","['Surgery versus cast immobilisation', 'cast immobilisation', 'surgical fixation with cast immobilisation', 'early surgical fixation (surgery group) or below-elbow cast immobilisation followed by immediate fixation if non-union of the fracture was confirmed (cast immobilisation group']","['total patient-rated wrist evaluation (PRWE) score', 'medical complication', 'potentially serious complication', 'mean PRWE scores', 'cast-related complications']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0448063', 'cui_str': 'Entire waist of scaphoid bone'}, {'cui': 'C0585059', 'cui_str': 'Fracture with displacement'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0587525', 'cui_str': 'Orthopedic department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0438837', 'cui_str': 'Below elbow cast'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.175409,"More participants in the surgery group (31 [14%] of 219 participants) had a potentially serious complication from surgery than in the cast immobilisation group (three [1%] of 220 participants), but fewer participants in the surgery group (five [2%]) had cast-related complications than in the cast immobilisation group (40 [18%]).","[{'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Dias', 'Affiliation': 'Leicester General Hospital, University Hospitals of Leicester National Health Service (NHS) Trust, Leicester, UK. Electronic address: jd96@le.ac.uk.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Brealey', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Fairhurst', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Rouin', 'Initials': 'R', 'LastName': 'Amirfeyz', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Bristol, UK.'}, {'ForeName': 'Bhaskar', 'Initials': 'B', 'LastName': 'Bhowal', 'Affiliation': 'Leicester General Hospital, University Hospitals of Leicester National Health Service (NHS) Trust, Leicester, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Blewitt', 'Affiliation': 'North Bristol NHS Trust, Southmead Hospital, Bristol, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brewster', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'The Royal Liverpool and Broadgreen University Hospitals NHS Trust, Royal Liverpool University Hospital, Liverpool, UK.'}, {'ForeName': 'Surabhi', 'Initials': 'S', 'LastName': 'Choudhary', 'Affiliation': 'University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Coapes', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Cook', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Costa', 'Affiliation': 'The Kadoorie Centre, John Radcliffe Hospital, Oxford, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Nuffield Orthopaedic Centre, Oxford, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Davis', 'Affiliation': ""Nottingham University Hospitals NHS Trust, Queen's Medical Centre Campus, Nottingham, UK.""}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Di Mascio', 'Affiliation': 'Barts Health NHS Trust, The Royal London Hospital, London, UK.'}, {'ForeName': 'Grey', 'Initials': 'G', 'LastName': 'Giddins', 'Affiliation': 'Royal United Hospital Bath NHS Trust, Royal United Hospital, Bath, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hedley', 'Affiliation': 'University Hospitals Coventry and Warwickshire NHS Trust, University Hospital, Coventry, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hewitt', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Hinde', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hobby', 'Affiliation': 'Hampshire Hospitals NHS Foundation Trust, Basingstoke and North Hampshire Hospital, Basingstoke, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Hodgson', 'Affiliation': 'Bolton NHS Foundation Trust, Royal Bolton Hospital, Bolton, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jefferson', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Kanagaratnam', 'Initials': 'K', 'LastName': 'Jeyapalan', 'Affiliation': 'Leicester General Hospital, University Hospitals of Leicester National Health Service (NHS) Trust, Leicester, UK.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Johnston', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Peterborough and Stamford Hospitals NHS Foundation Trust, Peterborough City Hospital, Peterborough, UK.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Keding', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Leighton', 'Affiliation': ""School of Medicine, University of Nottingham, Queen's Medical Centre, Nottingham, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Logan', 'Affiliation': 'Cardiff and Vale University of Health Board, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Mason', 'Affiliation': 'Gloucestershire Hospitals NHS Foundation Trust, Gloucestershire Royal Hospital, Gloucester, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McAndrew', 'Affiliation': 'Royal Berkshire NHS Foundation Trust, Royal Berkshire Hospital, Reading, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'McNab', 'Affiliation': 'Oxford University Hospitals NHS Trust, Nuffield Orthopaedic Centre, Oxford, UK.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Muir', 'Affiliation': 'Salford Royal Hospital NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Nicholl', 'Affiliation': 'Maidstone and Tunbridge Wells NHS Trust, Tunbridge Wells, Kent, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Northgraves', 'Affiliation': 'Hull Health Trials Unit, University of Hull, Hull, UK.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Palmer', 'Affiliation': 'Leicester General Hospital, University Hospitals of Leicester National Health Service (NHS) Trust, Leicester, UK.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Poulter', 'Affiliation': 'Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital, Truro, Cornwall, UK.'}, {'ForeName': 'Zulfi', 'Initials': 'Z', 'LastName': 'Rahimtoola', 'Affiliation': 'Royal Berkshire NHS Foundation Trust, Royal Berkshire Hospital, Reading, UK.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Rangan', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK; Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Nuffield Orthopaedic Centre, Oxford, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Richards', 'Affiliation': 'Poole Hospital NHS Foundation Trust, Poole, Dorset, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stuart', 'Affiliation': 'Newcastle upon Tyne Hospitals NHS Foundation Trust, Royal Victoria Infirmary, Newcastle upon Tyne, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Taub', 'Affiliation': 'Department of Health Sciences, University of Leicester, George Davies Centre, Leicester, UK.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Tavakkolizadeh', 'Affiliation': ""King's College Hospital NHS Foundation Trust, King's College Hospital, Brixton, London, UK.""}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Tew', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Department of Health Sciences, University of Leicester, George Davies Centre, Leicester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'York Trials Unit, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Warwick', 'Affiliation': 'University Hospital Southampton NHS Foundation Trust, Southampton General Hospital, Southampton, UK.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30931-4']
1890,32771678,Gamma transcranial alternating current stimulation improves mood and cognition in patients with major depression.,"Major depression is one of the most common psychiatric disorders with a high rate of treatment resistance where new treatment options are urgently warranted. One of these new options are non-invasive brain stimulation techniques like transcranial magnetic or electric stimulation. One of the latter is transcranial Alternating Current Stimulation (tACS) in various frequencies. Here, we report a case series of six patients suffering from major depression treated with tACS in gamma (40 Hz) frequency. Patients were randomized to two groups, receiving either two 10-min stimulations (group 1) or a 20-min stimulation or per day (group 2) over ten days. Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2). Results also showed an improvement in cognitive functions assessed by word fluency and n-back test. It is hypothesized that gamma tACS could help to synchronize disturbed frequency bands in frontal and prefrontal cortex areas and thus restore dysbalanced neural connectivity in psychiatric disorders.",2020,"Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2).","['six patients suffering from major depression treated with tACS in gamma (40\xa0Hz) frequency', 'patients with major depression']","['Gamma transcranial alternating current stimulation', 'transcranial Alternating Current Stimulation (tACS', 'gamma tACS']","['Hamilton Depression Rating Scale and Beck Depression Inventory', 'cognitive functions assessed by word fluency and n-back test', 'mood and cognition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]","[{'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.0221377,"Hamilton Depression Rating Scale and Beck Depression Inventory decreased during treatment in both study groups by 85% and 78% (group 1), or 62% and 24% respectively (group 2).","[{'ForeName': 'Nikolas', 'Initials': 'N', 'LastName': 'Haller', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Senner', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Institute of Psychiatric Phenomics and Genomics (IPPG), Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Andre R', 'Initials': 'AR', 'LastName': 'Brunoni', 'Affiliation': 'Department and Institute of Psychiatry, Laboratory of Neurosciences (LIM-27), University of Sao Paulo, Brazil.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Palm', 'Affiliation': 'Dept. of Psychiatry and Psychotherapy, Klinikum der Universität München, Munich, Germany; Medical Park Chiemseeblick, Bernau, Felden, Germany. Electronic address: u.palm@medicalpark.de.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.009']
1891,32771909,Implementation science outcomes of a gender-focused HIV and alcohol risk-reduction intervention in usual-care settings in South Africa.,"BACKGROUND


South Africa has the highest HIV prevalence globally, which disproportionately affects women. Hazardous alcohol use reduces antiretroviral adherence which can lead to adverse health. Few evidence-based interventions addressing hazardous alcohol use and HIV have been implemented in real-world settings. This study aimed to evaluate implementation outcomes from the Women's Health CoOp (WHC)-an evidence-based gender-focused HIV intervention-which was implemented in Cape Town.
METHODS


We conducted this implementation science trial using a modified stepped-wedge design. Four health clinics were paired with four substance use rehabilitation programs and randomized into four cycles. Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle). We assessed adoption, acceptability, appropriateness, cost, and fidelity using a mixed methods approach.
RESULTS


Adoption: 100 % of staff trained in the WHC and designated as interventionists delivered one or more workshops. Acceptability: Interventionists found the WHC content beneficial to their patients and the WHC improved connections between clinical units in facilities. Appropriateness: The WHC aligned with facility goals to improve antiretroviral adherence and reduce alcohol use; however, there were implementation challenges, including staff shortages, stigma, and few places to refer women for supportive services. Cost: The cost of implementing the WHC was 20.59 ZAR (1.40 USD) per attendee. Fidelity: Interventionists implemented the WHC with high fidelity and quality.
CONCLUSIONS


The findings suggest it is feasible to integrate the WHC into usual-care settings. Future efforts to scale up the intervention will need to address social and structural implementation challenges.
TRIAL REGISTRATION


NCT02733003 approved 1/21/2016.",2020,Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle).,"[""Women's Health CoOp (WHC)-an evidence-based gender-focused HIV intervention-which was implemented in Cape Town"", 'usual-care settings in South Africa', 'Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle', 'Four health clinics']",['gender-focused HIV and alcohol risk-reduction intervention'],"['Acceptability', 'Fidelity', 'adoption, acceptability, appropriateness, cost, and fidelity', 'antiretroviral adherence', 'Cost', 'cost of implementing the WHC']","[{'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}]",,0.0625822,Women living with HIV and who use alcohol or other drugs were recruited into each cycle (n = 120 each cycle).,"[{'ForeName': 'Margaret W', 'Initials': 'MW', 'LastName': 'Gichane', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Wendee M', 'Initials': 'WM', 'LastName': 'Wechsberg', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA; Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB #7445, Chapel Hill, NC, 27599, USA; Department of Psychology, North Carolina State University, 2310 Katharine Stinson Drive Raleigh, Raleigh, NC, 27607, USA; Psychiatry and Behavioral Sciences, Duke University School of Medicine, 40 Duke Medicine Circle, Durham, NC, 27710, USA. Electronic address: wmw@rti.org.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Ndirangu', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Felicia A', 'Initials': 'FA', 'LastName': 'Browne', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA; Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB #7445, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Courtney Peasant', 'Initials': 'CP', 'LastName': 'Bonner', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Grimwood', 'Affiliation': ""Kheth'Impilo AIDS Free Living, 11th Floor, Metlife Centre, 7 Walter Sisulu Avenue, Cape Town, 8000, South Africa.""}, {'ForeName': 'Najma', 'Initials': 'N', 'LastName': 'Shaikh', 'Affiliation': ""Kheth'Impilo AIDS Free Living, 11th Floor, Metlife Centre, 7 Walter Sisulu Avenue, Cape Town, 8000, South Africa.""}, {'ForeName': 'Brittni', 'Initials': 'B', 'LastName': 'Howard', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Zule', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, 27709, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108206']
1892,32771983,Randomised clinical trial of a gastrointestinal care bundle to reduce symptoms in patients with pelvic cancer undergoing chemoradiotherapy.,"OBJECTIVE


Pelvic radiotherapy is used to treat 17 000 people in the UK each year. Eight in 10 develop difficult bowel problems during pelvic treatment, especially diarrhoea, urgency and incontinence. Some cannot complete treatment, reducing the chance of cancer cure. Undertaking gastroenterologist-led investigation and management during pelvic radiotherapy has never been evaluated. In this study, we aimed to assess whether patients could successfully receive a novel gastrointestinal (GI) care bundle during chemoradiotherapy (feasibility aim) and would experience reduced symptom severity (clinical impact aim).
DESIGN


This randomised controlled trial recruited patients with cervical and bladder cancers undergoing radical chemoradiotherapy. Participants were randomised to intervention or control groups. Questionnaire and anthropometric data were collected. All intervention group patients received individualised dietary counselling weekly throughout treatment, and if bowel symptoms developed they were offered rapid-access investigation and treatment for any identified pathology: lactose intolerance, bacterial overgrowth or bile acid malabsorption.
RESULTS


Feasibility: 50 participants were recruited, 24 were randomised to the intervention group and 26 to the control group. All completed 20 fractions of external beam pelvic radiotherapy. It was possible to perform 57/72 (79%) of proposed intervention tests with no disruption of oncological management.
CLINICAL IMPACT


All participants developed GI symptoms during radiotherapy. The median symptom score for each group increased from baseline at 6 weeks. This was from 0.156 (0.000-0.333) to 0.600 (0.250-1.286) in the control group, and from 0.00 (0.000-0.300) to 0.402 (0.000-0.667) in the intervention group.
CONCLUSION


It was feasible to recruit to and deliver a randomised controlled trial of interventions in patients undergoing pelvic chemoradiotherapy. Lower median bowel scores were reported in the intervention group at 6 weeks, with fewer patients experiencing symptoms overall.
TRIAL REGISTRATION NUMBER


ISRCTN783488.",2020,"It was possible to perform 57/72 (79%) of proposed intervention tests with no disruption of oncological management.
","['17\u2009000 people in the UK each year', 'patients with pelvic cancer undergoing chemoradiotherapy', 'patients with cervical and bladder cancers undergoing', 'patients undergoing pelvic chemoradiotherapy']","['external beam pelvic radiotherapy', 'individualised dietary counselling weekly throughout treatment, and if bowel symptoms developed they were offered rapid-access investigation and treatment for any identified pathology: lactose intolerance, bacterial overgrowth or bile acid malabsorption', 'Pelvic radiotherapy', 'radical chemoradiotherapy', 'novel gastrointestinal (GI) care bundle during chemoradiotherapy']","['diarrhoea, urgency and incontinence', 'chance of cancer cure', 'GI symptoms', 'median symptom score', 'Lower median bowel scores']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751416', 'cui_str': 'Pelvic Cancer'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0022951', 'cui_str': 'Intolerance to lactose'}, {'cui': 'C0151521', 'cui_str': 'Bacterial resistance'}, {'cui': 'C2747802', 'cui_str': 'Bile acid malabsorption'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3658308', 'cui_str': 'Care Bundles'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}]",50.0,0.185933,"It was possible to perform 57/72 (79%) of proposed intervention tests with no disruption of oncological management.
","[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'White', 'Affiliation': 'Gastroenterology, Manchester Foundation Trust, Wythenshawe Hospital, Manchester, UK.'}, {'ForeName': 'Caroline C', 'Initials': 'CC', 'LastName': 'Henson', 'Affiliation': 'Gastroenterology, Manchester Foundation Trust, Wythenshawe Hospital, Manchester, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hann', 'Affiliation': 'Manchester Academic Health Sciences Centre, Health Innovation Manchester, Manchester, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eden', 'Affiliation': 'Manchester Academic Health Sciences Centre, Health Innovation Manchester, Manchester, UK.'}, {'ForeName': 'Sorrel T', 'Initials': 'ST', 'LastName': 'Burden', 'Affiliation': 'Manchester Academic Health Sciences Centre, Health Innovation Manchester, Manchester, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lal', 'Affiliation': 'Manchester Academic Health Sciences Centre, Health Innovation Manchester, Manchester, UK.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Davidson', 'Affiliation': 'Manchester Academic Health Sciences Centre, Health Innovation Manchester, Manchester, UK.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'McLaughlin', 'Affiliation': 'Manchester Academic Health Sciences Centre, Health Innovation Manchester, Manchester, UK John.Mclaughlin@manchester.ac.uk.'}]",BMJ open gastroenterology,['10.1136/bmjgast-2020-000432']
1893,32779497,"Pooled Analysis of Bleeding, Major Adverse Cardiovascular Events, and All-Cause Mortality in Clinical Trials of Time-Constrained Dual-Antiplatelet Therapy After Percutaneous Coronary Intervention.","Background The net clinical benefit of dual antiplatelet therapy (DAPT) reflects the paradoxical effects of an increased risk of bleeding and a reduced risk of major adverse cardiovascular events. A time-constrained approach to DAPT has been recently investigated in 5 multicenter trials including GLOBAL LEADERS, STOPDAPT2 (Short and Optimal Duration of Dual Antiplatelet Therapy After Everolimus-Eluting Cobalt-Chromium Stent-2), SMART-CHOICE, TWILIGHT (Ticagrelor With Aspirin or Alone in High-Risk Patients After Coronary Intervention), and TICO (Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome). Methods and Results We undertook a pooled analysis of these trials to assess the overall associations between time-constrained P2Y12 inhibitor monotherapy (aspirin-free regimen) for bleeding events, major adverse cardiovascular events, and all-cause mortality as compared to standard care with DAPT for at least 12 months post-percutaneous coronary intervention. We implemented a DerSimonian and Laird random effects meta-analysis using the metafor package in R. 32 361 randomized trial participants, including 16 898 (52.2%) who had a history of acute coronary syndrome, underwent percutaneous coronary intervention, and had outcome data available. P2Y12 inhibitor monotherapy from 1 to 3 months was associated with a reduced risk for bleeding (hazard ratio [HR] 0.60; 95% CI, 0.45-0.81), including in the acute coronary syndrome group in which the magnitude of risk reduction was greatest (HR 0.50; 95% CI, 0.41-0.61). The estimates of the effect of P2Y12 inhibitor monotherapy on the HR were also favorable for major adverse cardiovascular events (0.88; 95% CI, 0.77-1.02) and all-cause mortality (0.85; 95% CI, 0.71-1.03). Conclusions Compared with DAPT for 12 months post-percutaneous coronary intervention, P2Y12 inhibitor monotherapy from 1 to 3 months substantially reduces the risk of major and fatal bleeding and, in addition, confers potentially protective effects, for major adverse cardiovascular events and all-cause mortality. Considering patient safety, the results support a strategy of DAPT for 1 to 3 months followed by aspirin-free P2Y12 inhibitor monotherapy.",2020,"P2Y12 inhibitor monotherapy from 1 to 3 months was associated with a reduced risk for bleeding (hazard ratio [HR] 0.60; 95% CI, 0.45-0.81), including in the acute coronary syndrome group in which the magnitude of risk reduction was greatest (HR 0.50; 95% CI, 0.41-0.61).","['High-Risk Patients', 'R. 32\u2009361 randomized trial participants, including 16\xa0898 (52.2%) who had a history of acute coronary syndrome, underwent percutaneous coronary intervention, and had outcome data available', 'for Acute Coronary Syndrome']","['aspirin-free P2Y12 inhibitor monotherapy', 'STOPDAPT2', 'DAPT', 'Dual Antiplatelet Therapy', 'New Generation Sirolimus Stent', 'P2Y12 inhibitor monotherapy', 'Everolimus-Eluting Cobalt-Chromium Stent-2), SMART-CHOICE, TWILIGHT', 'Ticagrelor With Aspirin', 'dual antiplatelet therapy (DAPT', 'TICO (Ticagrelor Monotherapy', 'P2Y12 inhibitor monotherapy (aspirin-free regimen']","['Bleeding, Major Adverse Cardiovascular Events, and All-Cause Mortality', 'risk reduction', 'reduced risk for bleeding', 'major adverse cardiovascular events', 'bleeding events, major adverse cardiovascular events', 'risk of major and fatal bleeding']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517801', 'cui_str': '52.2'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}]",,0.0468397,"P2Y12 inhibitor monotherapy from 1 to 3 months was associated with a reduced risk for bleeding (hazard ratio [HR] 0.60; 95% CI, 0.45-0.81), including in the acute coronary syndrome group in which the magnitude of risk reduction was greatest (HR 0.50; 95% CI, 0.41-0.61).","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'McClure', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow United Kingdom.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Ramsay', 'Affiliation': 'West of Scotland Heart and Lung Centre Golden Jubilee National Hospital Clydebank United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'British Heart Foundation Glasgow Cardiovascular Research Centre Institute of Cardiovascular and Medical Sciences University of Glasgow United Kingdom.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.017109']
1894,32779505,"Effects of Epeleuton, a Novel Synthetic Second-Generation n-3 Fatty Acid, on Non-Alcoholic Fatty Liver Disease, Triglycerides, Glycemic Control, and Cardiometabolic and Inflammatory Markers.","Background Epeleuton is 15-hydroxy eicosapentaenoic acid ethyl ester, a second-generation synthetic n-3 fatty acid derivative of eicosapentaenoic acid. The primary objective was to assess the effect of epeleuton on markers of nonalcoholic fatty liver disease (NAFLD) with post hoc analyses of cardiometabolic markers. Methods and Results In a multicenter, randomized, double-blind, placebo-controlled trial, 96 adults with nonalcoholic fatty liver disease and body mass index 25 to 40 were randomized in a 1:1:1 ratio to receive epeleuton 2 g/day, epeleuton 1 g/day, or placebo for 16 weeks. A total of 27% of patients had diabetes mellitus. Primary end points of changes in alanine aminotransferase and liver stiffness did not improve at week 16. Secondary and post hoc analyses investigated changes in cardiometabolic markers. Epeleuton 2 g/day significantly decreased triglycerides, very-low-density lipoprotein cholesterol, and total cholesterol without increasing low-density lipoprotein cholesterol. Despite a low mean baseline hemoglobin A1C (HbA 1C ; 6.3±1.3%), epeleuton 2 g/day significantly decreased HbA 1c  (-0.4%;  P =0.026). Among patients with baseline HbA 1c  >6.5%, epeleuton 2 g/day decreased HbA 1c  by 1.1% ( P =0.047; n=26). Consistent dose-dependent reductions were observed for fasting plasma glucose, insulin, and insulin resistance indices. Epeleuton 2 g/day decreased circulating markers of cardiovascular risk and endothelial dysfunction. Epeleuton was well tolerated, with a safety profile not different from placebo. Conclusions While epeleuton did not meet its primary end points on alanine aminotransferase or liver stiffness, it significantly decreased triglycerides, HbA 1C , plasma glucose, and inflammatory markers. These data suggest epeleuton may have potential for cardiovascular risk reduction and nonalcoholic fatty liver disease by simultaneously targeting hypertriglyceridemia, hyperglycemia, and systemic inflammation. Further trials are planned. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT02941549.",2020,"Epeleuton 2 g/day significantly decreased triglycerides, very-low-density lipoprotein cholesterol, and total cholesterol without increasing low-density lipoprotein cholesterol.",['96 adults with nonalcoholic fatty liver disease and body mass index 25 to 40'],"['Registration URL', 'Epeleuton, a Novel Synthetic Second-Generation n-3 Fatty Acid', 'epeleuton 2\xa0g/day, epeleuton 1\xa0g/day, or placebo', 'placebo']","['cardiometabolic markers', 'circulating markers of cardiovascular risk and endothelial dysfunction', 'triglycerides, very-low-density lipoprotein cholesterol, and total cholesterol without increasing low-density lipoprotein cholesterol', 'nonalcoholic fatty liver disease (NAFLD', 'Non-Alcoholic Fatty Liver Disease, Triglycerides, Glycemic Control, and Cardiometabolic and Inflammatory Markers', 'fasting plasma glucose, insulin, and insulin resistance indices', 'diabetes mellitus', 'triglycerides, HbA 1C , plasma glucose, and inflammatory markers', 'alanine aminotransferase and liver stiffness', 'alanine aminotransferase or liver stiffness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023826', 'cui_str': 'VLDL cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]",96.0,0.456088,"Epeleuton 2 g/day significantly decreased triglycerides, very-low-density lipoprotein cholesterol, and total cholesterol without increasing low-density lipoprotein cholesterol.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Climax', 'Affiliation': 'Afimmune Dublin Ireland.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Newsome', 'Affiliation': 'National Institute for Health Research Biomedical Research Centre at University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham United Kingdom.'}, {'ForeName': 'Moayed', 'Initials': 'M', 'LastName': 'Hamza', 'Affiliation': 'Afimmune Dublin Ireland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Weissbach', 'Affiliation': 'Afimmune Dublin Ireland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Coughlan', 'Affiliation': 'Afimmune Dublin Ireland.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences University of Glasgow United Kingdom.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center Dallas TX.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center Harvard Medical School Boston MA.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.016334']
1895,32779534,Acute effects of body-weight resistance exercises on blood pressure and glycemia in middle-aged adults with hypertension.,"OBJECTIVE


The purpose of the present study was to evaluate the acute effects of single session of body-weight resistance exercises on blood pressure (BP) and glycemia in middle-aged adults with hypertension.
METHODS


Twenty-three participants took part in this trial with crossover design and performed two experimental sessions in a random order: Body-weight resistance exercise session (BWR) and a control session without exercise. BWR was composed of four exercises: inverted row, squat, , and sit-ups. The participants performed 3 sets of 30 s, in which they were instructed to perform as much repetitions as possible and as fast as possible. After each session, BP and glycemia were measured continuously for 60 min.
RESULTS


Systolic BP decreased after BWR when compared with control at post 45': -7 (95%CI:-11 to -2) mmHg,  p  = .003 and post60': -7 (95%CI:-12 to -3) mmHg,  p  = .003. Diastolic BP decreased after BWR when compared with control at post 15': -6 (95%CI:-9 to -3) mmHg,  p  < .001; post 30': -6 (95%CI:-9 to -2) mmHg,  p  = .001; post45': -5 (95%CI:-9 to -2) mmHg,  p  = .005; and post60': -6 (95%CI: -8 to -3) mmHg,  p  < .001. No significant difference was found in glycemia between BWR and control sessions.
CONCLUSION


BWR acutely reduces BP in middle-aged adults with hypertension without effects on usual glycemia responses. This alternative form of resistance training could facilitate access, adherence, and reduce health costs related to exercise programs.",2020,Diastolic BP decreased after BWR when compared with control at post 15': -6,"['middle-aged adults with hypertension', 'Twenty-three participants took part in this trial with crossover design and performed two experimental sessions in a random order']","['Body-weight resistance exercise session (BWR) and a control session without exercise', 'body-weight resistance exercises']","['glycemia', 'Systolic BP', 'blood pressure (BP) and glycemia', 'Diastolic BP', 'BP and glycemia', 'blood pressure and glycemia', 'BP']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",23.0,0.0731685,Diastolic BP decreased after BWR when compared with control at post 15': -6,"[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ferrari', 'Affiliation': 'Universidade Federal Do Rio Grande Do Sul , Porto Alegre, Brazil.'}, {'ForeName': 'Eduardo Lusa', 'Initials': 'EL', 'LastName': 'Cadore', 'Affiliation': 'Universidade Federal Do Rio Grande Do Sul , Porto Alegre, Brazil.'}, {'ForeName': 'Bibiana', 'Initials': 'B', 'LastName': 'Périco', 'Affiliation': 'Faculdade Sogipa de Educação Física , Porto Alegre, Brazil.'}, {'ForeName': 'Gabriela Bartholomay', 'Initials': 'GB', 'LastName': 'Kothe', 'Affiliation': 'Faculdade Sogipa de Educação Física , Porto Alegre, Brazil.'}]","Clinical and experimental hypertension (New York, N.Y. : 1993)",['10.1080/10641963.2020.1806293']
1896,32782008,Predictors of low back disability in chiropractic and physical therapy settings.,"BACKGROUND


Predicting ongoing disability for chronic non-specific low back pain (LBP) is important to avoid prolonged disability.
OBJECTIVE


Determine predictors of disability at 6 month follow-up in patients with LBP at medium risk of ongoing disability.
METHODS


Baseline data was collected from 108 patients with medium-risk chronic non-specific LBP (mean age 50.4 years, SD 13.6) from six private chiropractic and physiotherapy clinics in Australia who took part in a randomised control trial. All patients received a pragmatic course of multimodal physical treatments [e.g., manual therapy (spinal manipulation or mobilization and/or soft tissue massage)] combined with advice, education and exercise. Baseline prognostic variables included sociodemographic, physical and psychological characteristics. Primary outcome was disability (Roland Morris Disability) at 6 month follow-up. Multivariable linear regression analysis was conducted.
RESULTS


Variables remaining in the final multivariable model: lower work ability (β = - 1.05, 95% CI - 1.40 to - 0.70; p < 0.0001) and consultation with a medical specialist for back pain in the preceding 3 months (β = 3.35, 95% CI 1.14 to 5.55; p < 0.003), which significantly predicted higher disability at 6 months (unadjusted R  2  = 0.31). Those with a lower work ability (scale 1 to 10) and who had seen a medical specialist for their back pain were more likely to report greater LBP-related disability at 6 months.
CONCLUSION


Patients with chronic LBP presenting to primary care with lower work ability and recent consultation with a medical specialist for LBP are more likely to have a worse prognosis; these are indicators to clinicians that standard conservative care may not adequately manage the patients' needs.",2020,"RESULTS


Variables remaining in the final multivariable model: lower work ability (β = - 1.05, 95% CI - 1.40 to - 0.70;","['patients with LBP at medium risk of ongoing disability', 'Patients with chronic LBP presenting to primary care with lower work ability and recent consultation with a medical specialist for LBP', '108 patients with medium-risk chronic non-specific LBP (mean age 50.4\u2009years, SD 13.6) from six private chiropractic and physiotherapy clinics in Australia who took part in a randomised control trial']","['multimodal physical treatments [e.g., manual therapy (spinal manipulation or mobilization and/or soft tissue massage)] combined with advice, education and exercise']","['sociodemographic, physical and psychological characteristics', 'consultation with a medical specialist for back pain', 'disability (Roland Morris Disability', 'disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0008138', 'cui_str': 'Chiropractic'}, {'cui': 'C3839152', 'cui_str': 'Physiotherapy clinic'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0086586', 'cui_str': 'Manipulation of spine'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0556852', 'cui_str': 'Soft tissue massage'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",108.0,0.0812215,"RESULTS


Variables remaining in the final multivariable model: lower work ability (β = - 1.05, 95% CI - 1.40 to - 0.70;","[{'ForeName': 'M John', 'Initials': 'MJ', 'LastName': 'Petrozzi', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Rm S223, S Block, Sydney School of Health Sciences, Cumberland Campus NSW, Sydney, 2141, Australia. mpet9893@uni.sydney.edu.au.'}, {'ForeName': 'Sidney M', 'Initials': 'SM', 'LastName': 'Rubinstein', 'Affiliation': 'Department of Health Sciences, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Paulo H', 'Initials': 'PH', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Rm S223, S Block, Sydney School of Health Sciences, Cumberland Campus NSW, Sydney, 2141, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Leaver', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Rm S223, S Block, Sydney School of Health Sciences, Cumberland Campus NSW, Sydney, 2141, Australia.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Mackey', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Rm S223, S Block, Sydney School of Health Sciences, Cumberland Campus NSW, Sydney, 2141, Australia.'}]",Chiropractic & manual therapies,['10.1186/s12998-020-00328-3']
1897,32782010,"The effects of spinach-derived thylakoid supplementation in combination with calorie restriction on anthropometric parameters and metabolic profiles in obese women with polycystic ovary syndrome: a randomized, double-blind, placebo-controlled clinical trial.","BACKGROUND


There is a promising outlook regarding the potential effect of spinach-derived thylakoids in the management of obesity and its associated metabolic disturbances. This research aimed to evaluate the effects of spinach-derived thylakoids supplementation combined with a calorie-restricted diet on anthropometric and metabolic profiles in obese women with the polycystic ovary syndrome (PCOS).
METHODS


In a 12-week double-blind placebo-controlled randomized clinical trial, 48 females with obesity and PCOS were randomly allocated into either intervention (5 g/day thylakoid) or placebo (5 g/day cornstarch) groups along with calorie-restricted diets. Anthropometric measures, physical activity levels, dietary intakes, insulin resistance markers, as well as serum levels of insulin, fasting blood glucose (FBG), non-esterified fatty acids (NEFA), and sex hormones including dehydroepiandrosterone sulfate (DHEAS), follicle-stimulating hormone (FSH), luteinizing hormone (LH), sex hormone-binding globulin (SHBG), and free androgen index (FAI) were evaluated pre-and post-intervention.
RESULTS


After the 12-week intervention, there were significant decreases in weight (- 6.97 ± 0.52 vs. -3.19 ± 0.72 kg; P < 0.001), waist circumference (- 7.78 ± 2.50 vs. -3.73 ± 1.40 cm; P < 0.001), fat mass (- 5.19 ± 0.53 vs. -1.36 ± 0.39 kg; P < 0.001), and insulin levels (- 5.40 ± 1.86 vs. -1.19 ± 0.85 μU/mL; P < 0.001) in the spinach-derived thylakoid group compared to the placebo group. Furthermore, insulin resistance markers and serum levels of testosterone decreased significantly in the thylakoid group compared to the placebo group (P < 0.05). The changes in other parameters did not show significant differences between the two groups.
CONCLUSIONS


Spinach-derived thylakoid supplementation resulted in more favorable improvements in anthropometric indices and insulin sensitivity compared to the calorie restriction alone.
TRIAL REGISTRATION


The study was approved by the Ethics Committee of Research Vice-chancellor of Tabriz University of Medical Sciences, Tabriz, Iran, and was registered in the Iranian Registry of Clinical Trials (registration ID: IRCT20140907019082N9 ).",2020,"Furthermore, insulin resistance markers and serum levels of testosterone decreased significantly in the thylakoid group compared to the placebo group (P < 0.05).","['obese women with polycystic ovary syndrome', 'obese women with the polycystic ovary syndrome (PCOS', '48 females with obesity and PCOS']","['calorie restriction', 'spinach-derived thylakoid supplementation', 'Spinach-derived thylakoid supplementation', 'spinach-derived thylakoids supplementation combined with a calorie-restricted diet', 'calorie-restricted diets', 'placebo']","['weight', 'waist circumference', 'anthropometric indices and insulin sensitivity', 'Furthermore, insulin resistance markers and serum levels of testosterone', 'anthropometric parameters and metabolic profiles', 'fat mass', 'Anthropometric measures, physical activity levels, dietary intakes, insulin resistance markers, as well as serum levels of insulin, fasting blood glucose (FBG), non-esterified fatty acids (NEFA), and sex hormones including dehydroepiandrosterone sulfate (DHEAS), follicle-stimulating hormone (FSH), luteinizing hormone (LH), sex hormone-binding globulin (SHBG), and free androgen index (FAI', 'insulin levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0242949', 'cui_str': 'Spinach'}, {'cui': 'C1879336', 'cui_str': 'Thylakoids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0036884', 'cui_str': 'Sex hormone'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0057277', 'cui_str': 'Dehydroepiandrosterone sulfate'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}, {'cui': 'C0428629', 'cui_str': 'Free androgen index measurement'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}]",48.0,0.696044,"Furthermore, insulin resistance markers and serum levels of testosterone decreased significantly in the thylakoid group compared to the placebo group (P < 0.05).","[{'ForeName': 'Fatemeh Pourteymour Fard', 'Initials': 'FPF', 'LastName': 'Tabrizi', 'Affiliation': 'Nutrition Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mahdieh Abbasalizad', 'Initials': 'MA', 'LastName': 'Farhangi', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Attar-neishabouri Ave, Golgasht St, Tabriz, 5165665931, Iran. abbasalizad_m@yahoo.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Vaezi', 'Affiliation': ""Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.""}, {'ForeName': 'Salar', 'Initials': 'S', 'LastName': 'Hemmati', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}]",Nutrition journal,['10.1186/s12937-020-00601-4']
1898,32783421,Prospective Clinical Trial of Intravitreal Aflibercept Treat-and-extend Regimen for Diabetic Macular Edema: 1-Year Outcomes.,"PURPOSE


To investigate the efficacy of aflibercept for the treatment of diabetic macular edema via a treat-and-extend regimen.
METHODS


This prospective, single-center, open-label, interventional study involved 30 patients with a best-corrected visual acuity (BCVA) ≤0.6 and a central retinal thickness (CRT) ≥300 μm. The enrolled eyes each received a monthly intravitreal aflibercept injection until the CRT decreased below 300 μm, upon which the administration interval was extended for 1 month until the CRT once again increased to ≥300 μm. Main outcome measures were median BCVA and CRT at 6 and 12 months after initiation of treatment via last observation carried forward analysis, the median number of injections over the 12 months, and the effects on the diabetic retinopathy severity scale (DRSS) score of the patients who completed the 12-month follow-up period.
RESULTS


Of the 30 enrolled patients, 29 and 25 respectively completed the 6- and 12-month follow-up examinations. From baseline to 6 and 12 months after treatment initiation, the median BCVA (logarithm of the minimum angle of resolution) significantly improved from 0.52 to 0.30 and 0.35, respectively, and the median CRT significantly decreased from 439.5 to 268.5 and 249.0 μm, respectively. The median number of injections over the 12-month follow-up period was 6.0. Compared to baseline, the DRSS score at 12 months was improved by 2 steps in 16% of patients; in no cases did the DRSS score worsen or improve by three steps or more.
CONCLUSIONS


When administered in a treat-and-extend regimen, aflibercept is an effective treatment option for diabetic macular edema.",2020,"Compared to baseline, the DRSS score at 12 months was improved by 2 steps in 16% of patients; in no cases did the DRSS score worsen or improve by three steps or more.
","['Of the 30 enrolled patients, 29 and 25 respectively completed the 6- and 12-month follow-up examinations', 'Diabetic Macular Edema', '30 patients with a best-corrected visual acuity (BCVA) ≤0.6 and a central retinal thickness (CRT) ≥300 μm', 'diabetic macular edema']","['Intravitreal Aflibercept Treat-and-extend Regimen', 'aflibercept', 'intravitreal aflibercept injection']","['DRSS score', 'median BCVA', 'median CRT', 'diabetic retinopathy severity scale (DRSS) score', 'median BCVA and CRT', 'median number of injections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}]","[{'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",30.0,0.0388755,"Compared to baseline, the DRSS score at 12 months was improved by 2 steps in 16% of patients; in no cases did the DRSS score worsen or improve by three steps or more.
","[{'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Mieno', 'Affiliation': 'Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Kazuhito', 'Initials': 'K', 'LastName': 'Yoneda', 'Affiliation': 'Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan. kazuyone@koto.kpu-m.ac.jp.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Terao', 'Affiliation': 'Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Yoshii', 'Affiliation': 'Department of Mathematics and Statistics in Medical Sciences, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Kojima', 'Affiliation': 'Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Nagata', 'Affiliation': 'Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Chie', 'Initials': 'C', 'LastName': 'Sotozono', 'Affiliation': 'Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}]",Korean journal of ophthalmology : KJO,['10.3341/kjo.2020.0003']
1899,32757521,Subcutaneous or Transvenous Defibrillator Therapy.,"BACKGROUND


The subcutaneous implantable cardioverter-defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing these systems has been based primarily on observational studies.
METHODS


We conducted a noninferiority trial in which patients with an indication for an ICD but no indication for pacing were assigned to receive a subcutaneous ICD or transvenous ICD. The primary end point was the composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD) was 1.45. A superiority analysis was prespecified if noninferiority was established. Secondary end points included death and appropriate shocks.
RESULTS


A total of 849 patients (426 in the subcutaneous ICD group and 423 in the transvenous ICD group) were included in the analyses. At a median follow-up of 49.1 months, a primary end-point event occurred in 68 patients in the subcutaneous ICD group and in 68 patients in the transvenous ICD group (48-month Kaplan-Meier estimated cumulative incidence, 15.1% and 15.7%, respectively; hazard ratio, 0.99; 95% confidence interval [CI], 0.71 to 1.39; P = 0.01 for noninferiority; P = 0.95 for superiority). Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30). Death occurred in 83 patients in the subcutaneous ICD group and in 68 in the transvenous ICD group (hazard ratio, 1.23; 95% CI, 0.89 to 1.70); appropriate shocks occurred in 83 and 57 patients, respectively (hazard ratio, 1.52; 95% CI, 1.08 to 2.12).
CONCLUSIONS


In patients with an indication for an ICD but no indication for pacing, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks. (Funded by Boston Scientific; PRAETORIAN ClinicalTrials.gov number, NCT01296022.).",2020,"Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30).","['patients with an indication for an ICD but no indication for pacing', '849 patients (426 in the subcutaneous ICD group and 423 in the transvenous ICD group) were included in the analyses']","['Subcutaneous or Transvenous Defibrillator Therapy', 'subcutaneous implantable cardioverter-defibrillator (ICD', 'subcutaneous ICD or transvenous ICD', 'subcutaneous ICD', 'transvenous ICD']","['death and appropriate shocks', 'inappropriate shocks', 'composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD', 'Device-related complications', 'appropriate shocks', 'Death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0521090', 'cui_str': 'No indication of'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0180307', 'cui_str': 'Defibrillator'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}]",849.0,0.240788,"Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30).","[{'ForeName': 'Reinoud E', 'Initials': 'RE', 'LastName': 'Knops', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Louise R A', 'Initials': 'LRA', 'LastName': 'Olde Nordkamp', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Peter-Paul H M', 'Initials': 'PHM', 'LastName': 'Delnoy', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Lucas V A', 'Initials': 'LVA', 'LastName': 'Boersma', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Kuschyk', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Mikhael F', 'Initials': 'MF', 'LastName': 'El-Chami', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Bonnemeier', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Elijah R', 'Initials': 'ER', 'LastName': 'Behr', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Tom F', 'Initials': 'TF', 'LastName': 'Brouwer', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kääb', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Anne-Floor B E', 'Initials': 'ABE', 'LastName': 'Quast', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Lonneke', 'Initials': 'L', 'LastName': 'Smeding', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Willeke', 'Initials': 'W', 'LastName': 'van der Stuijt', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'de Weger', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Koen C', 'Initials': 'KC', 'LastName': 'de Wilde', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Nick R', 'Initials': 'NR', 'LastName': 'Bijsterveld', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Richter', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Brouwer', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Joris R', 'Initials': 'JR', 'LastName': 'de Groot', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Kirsten M', 'Initials': 'KM', 'LastName': 'Kooiman', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Pier D', 'Initials': 'PD', 'LastName': 'Lambiase', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Neuzil', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Vernooy', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Alings', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Tim R', 'Initials': 'TR', 'LastName': 'Betts', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Frank A L E', 'Initials': 'FALE', 'LastName': 'Bracke', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Burke', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Jonas S S G', 'Initials': 'JSSG', 'LastName': 'de Jong', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Wright', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': 'Arthur A M', 'Initials': 'AAM', 'LastName': 'Wilde', 'Affiliation': ""From the Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam University Medical Centers, University of Amsterdam (R.E.K., L.R.A.O.N., L.V.A.B., T.F.B., A.-F.B.E.Q., L.S., W.S., A.W., K.C.W., J.R.G., K.M.K., M.C.B., J.G.P.T., A.A.M.W.), ERN GUARD-Heart (E.R.B., P.D.L., A.A.M.W.), and the Department of Cardiology, OLVG (J.S.S.G.J.), Amsterdam, the Department of Cardiology, Isala Heart Centre, Zwolle (P.-P.H.M.D.), the Department of Cardiology, St. Antonius Hospital, Nieuwegein (L.V.A.B.), the Department of Cardiology, Flevoziekenhuis, Almere (N.R.B.), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.A.B.), the Department of Cardiology, Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, Maastricht (K.V.), the Department of Cardiology, Amphia Hospital, Breda (M.A.), Werkgroep Cardiologische Centra Nederland, Utrecht (M.A.), and the Department of Electrophysiology, Catharina Hospital, Eindhoven (F.A.L.E.B.) - all in the Netherlands; the First Department of Medicine-Cardiology, University Medical Center Mannheim, and the German Center for Cardiovascular Research Partner Site Heidelberg-Mannheim, Mannheim (J.K.), Klinik für Innere Medizin III, Schwerpunkt Kardiologie und Angiologie, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel (H.B.), the Department of Medicine I, Ludwig-Maximilians University Hospital, and the German Center for Cardiovascular Research, Munich Heart Alliance, Munich (S.K.), and the Department of Electrophysiology, Heart Center at University of Leipzig, Leipzig (S.R.) - all in Germany; the Division of Cardiology Section of Electrophysiology, Emory University, Atlanta (M.F.E.-C.); the Cardiology Clinical Academic Group, St. George's, University of London and St. George's University Hospitals NHS Foundation Trust London (E.R.B.), and Office of the Director of Clinical Electrophysiology Research and Lead for Inherited Arrhythmia Specialist Services, University College London and Barts Heart Centre (P.D.L.), London, the Oxford Biomedical Research Centre, Oxford University Hospitals NHS Trust, Oxford (T.R.B.), and Liverpool Heart and Chest Hospital, Liverpool (D.J.W.) - all in the United Kingdom; Valley Health System, Ridgewood, NJ (S.M.); the Department of Cardiology, Homolka Hospital, Prague, Czech Republic (P.N.); and CorVita Science Foundation, Chicago (M.C.B.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1915932']
1900,32757523,Ofatumumab versus Teriflunomide in Multiple Sclerosis.,"BACKGROUND


Ofatumumab, a subcutaneous anti-CD20 monoclonal antibody, selectively depletes B cells. Teriflunomide, an oral inhibitor of pyrimidine synthesis, reduces T-cell and B-cell activation. The relative effects of these two drugs in patients with multiple sclerosis are not known.
METHODS


In two double-blind, double-dummy, phase 3 trials, we randomly assigned patients with relapsing multiple sclerosis to receive subcutaneous ofatumumab (20 mg every 4 weeks after 20-mg loading doses at days 1, 7, and 14) or oral teriflunomide (14 mg daily) for up to 30 months. The primary end point was the annualized relapse rate. Secondary end points included disability worsening confirmed at 3 months or 6 months, disability improvement confirmed at 6 months, the number of gadolinium-enhancing lesions per T1-weighted magnetic resonance imaging (MRI) scan, the annualized rate of new or enlarging lesions on T2-weighted MRI, serum neurofilament light chain levels at month 3, and change in brain volume.
RESULTS


Overall, 946 patients were assigned to receive ofatumumab and 936 to receive teriflunomide; the median follow-up was 1.6 years. The annualized relapse rates in the ofatumumab and teriflunomide groups were 0.11 and 0.22, respectively, in trial 1 (difference, -0.11; 95% confidence interval [CI], -0.16 to -0.06; P<0.001) and 0.10 and 0.25 in trial 2 (difference, -0.15; 95% CI, -0.20 to -0.09; P<0.001). In the pooled trials, the percentage of patients with disability worsening confirmed at 3 months was 10.9% with ofatumumab and 15.0% with teriflunomide (hazard ratio, 0.66; P = 0.002); the percentage with disability worsening confirmed at 6 months was 8.1% and 12.0%, respectively (hazard ratio, 0.68; P = 0.01); and the percentage with disability improvement confirmed at 6 months was 11.0% and 8.1% (hazard ratio, 1.35; P = 0.09). The number of gadolinium-enhancing lesions per T1-weighted MRI scan, the annualized rate of lesions on T2-weighted MRI, and serum neurofilament light chain levels, but not the change in brain volume, were in the same direction as the primary end point. Injection-related reactions occurred in 20.2% in the ofatumumab group and in 15.0% in the teriflunomide group (placebo injections). Serious infections occurred in 2.5% and 1.8% of the patients in the respective groups.
CONCLUSIONS


Among patients with multiple sclerosis, ofatumumab was associated with lower annualized relapse rates than teriflunomide. (Funded by Novartis; ASCLEPIOS I and II ClinicalTrials.gov numbers, NCT02792218 and NCT02792231.).",2020,"Among patients with multiple sclerosis, ofatumumab was associated with lower annualized relapse rates than teriflunomide.","['patients with multiple sclerosis', '946 patients were assigned to receive ofatumumab and 936 to receive']","['Ofatumumab versus Teriflunomide', 'teriflunomide', 'Teriflunomide', 'subcutaneous ofatumumab', 'oral teriflunomide']","['disability worsening confirmed at 3 months or 6 months, disability improvement', 'annualized relapse rate', 'number of gadolinium-enhancing lesions per T1-weighted MRI scan, the annualized rate of lesions on T2-weighted MRI, and serum neurofilament light chain levels', 'Serious infections', 'percentage with disability worsening', 'percentage with disability improvement', 'disability worsening', 'Injection-related reactions', 'T-cell and B-cell activation', 'annualized relapse rates', 'number of gadolinium-enhancing lesions per T1-weighted magnetic resonance imaging (MRI) scan, the annualized rate of new or enlarging lesions on T2-weighted MRI, serum neurofilament light chain levels at month 3, and change in brain volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1832027', 'cui_str': 'ofatumumab'}]","[{'cui': 'C1832027', 'cui_str': 'ofatumumab'}, {'cui': 'C1718383', 'cui_str': 'teriflunomide'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C1562562', 'cui_str': 'Light chain level'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C3160907', 'cui_str': 'Injection related reaction'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",946.0,0.212435,"Among patients with multiple sclerosis, ofatumumab was associated with lower annualized relapse rates than teriflunomide.","[{'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Hauser', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Bar-Or', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Cohen', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Giancarlo', 'Initials': 'G', 'LastName': 'Comi', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Correale', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Coyle', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Cross', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'de Seze', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leppert', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Montalban', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Selmaj', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Wiendl', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Kerloeguen', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Willi', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Bingbing', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Algirdas', 'Initials': 'A', 'LastName': 'Kakarieka', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Davorka', 'Initials': 'D', 'LastName': 'Tomic', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Goodyear', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Ratnakar', 'Initials': 'R', 'LastName': 'Pingili', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Dieter A', 'Initials': 'DA', 'LastName': 'Häring', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Ramanathan', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Merschhemke', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': 'Ludwig', 'Initials': 'L', 'LastName': 'Kappos', 'Affiliation': ""From the UCSF Weill Institute for Neurosciences, Department of Neurology, University of California, San Francisco, San Francisco (S.L.H.); the Center for Neuroinflammation and Experimental Therapeutics and Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia (A.B.-O.); the Department of Neurology, Mellen Center for Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland (J.A.C.); the Institute of Experimental Neurology and Multiple Sclerosis Center IRCCS, San Raffaele Hospital, Milan (G.C.); the Department of Neurology, Fleni, Buenos Aires (J.C.); the Department of Neurology, Stony Brook University, Stony Brook, NY (P.K.C.); Washington University School of Medicine, St. Louis (A.H.C.); the University Hospital of Strasburg and Clinical Investigation Center INSERM 1434, Strasburg, France (J.S.); University Hospital Basel (D.L.), Novartis Pharma (C.K., R.W., A.K., D.T., D.A.H., K.R., M.M.), and the Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital and University of Basel (L.K.) - all in Basel, Switzerland; the Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitari Vall d'Hebron, Barcelona (X.M.); the University of Warmia and Mazury, Olsztyn, and the Center of Neurology, Lodz - both in Poland (K.S.); the Department of Neurology with Institute of Translational Neurology, University of Münster, Münster, Germany (H.W.); and Novartis Pharmaceuticals, East Hanover, NJ (B.L., A.G., R.P.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1917246']
1901,32787943,"Effectiveness of a family-, school- and community-based intervention on physical activity and its correlates in Belgian families with an increased risk for type 2 diabetes mellitus: the Feel4Diabetes-study.","BACKGROUND


The study aimed to investigate the effectiveness of the European Feel4Diabetes intervention, promoting a healthy lifestyle, on physical activity and its correlates among families at risk for type 2 diabetes mellitus (based on the Finnish Diabetes Risk Score) in Belgium.
METHODS


The Feel4Diabetes intervention involved three components: family, school and community component, with the family component consisting of 6 counseling sessions for families at risk. Main outcomes were objectively measured physical activity levels and its subjectively measured correlates. The final sample consisted of 454 parents (mean age 39.4 years; 72.0% women) and 444 children (mean age 8.0 years; 50.1% girls). Multilevel repeated measures analyses were performed to assess intervention effectiveness after 1 year.
RESULTS


In parents, there was no significant intervention effect. In children, there were only significant negative effects for moderate to vigorous physical activity (p = 0.05; η p 2  = 0.008) and steps (p = 0.03; η p 2  = 0.006%) on weekdays, with physical activity decreasing (more) in the intervention group.
CONCLUSIONS


The F4D-intervention lacks effectiveness on high-risk families' physical activity and its correlates in Belgium. This could partially be explained by low attendance rates and a large drop-out. To reach vulnerable populations, future interventions should invest in more appropriate recruitment (e.g. more face-to-face contact) and more bottom-up development of the intervention (i.e. co-creation of the intervention with the target group).
TRIAL REGISTRATION


The Feel4Diabetes-study was prospectively registered at clinicaltrials.gov as NCT02393872 on 20 March 2015.",2020,"In children, there were only significant negative effects for moderate to vigorous physical activity (p = 0.05; η p 2  = 0.008) and steps (p = 0.03; η p 2  = 0.006%) on weekdays, with physical activity decreasing (more) in the intervention group.
","['families at risk for type 2 diabetes mellitus (based on the Finnish Diabetes Risk Score) in Belgium', '454 parents (mean age 39.4\u2009years; 72.0% women) and 444 children (mean age 8.0\u2009years; 50.1% girls', 'Belgian families with an increased risk for type 2 diabetes mellitus']","['European Feel4Diabetes intervention', 'school and community component, with the family component consisting of 6 counseling sessions', 'family-, school- and community-based intervention']","['physical activity levels and its subjectively measured correlates', 'vigorous physical activity']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2732678', 'cui_str': 'Finnish diabetes risk score'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0261711,"In children, there were only significant negative effects for moderate to vigorous physical activity (p = 0.05; η p 2  = 0.008) and steps (p = 0.03; η p 2  = 0.006%) on weekdays, with physical activity decreasing (more) in the intervention group.
","[{'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Huys', 'Affiliation': 'Department of Movement and Sport Sciences, Ghent University, Watersportlaan 2, 9000, Ghent, Belgium. huysnele@gmail.com.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Van Stappen', 'Affiliation': 'Department of Movement and Sport Sciences, Ghent University, Watersportlaan 2, 9000, Ghent, Belgium.'}, {'ForeName': 'Samyah', 'Initials': 'S', 'LastName': 'Shadid', 'Affiliation': 'Department of Endocrinology and Metabolic Diseases, Ghent University Hospital, Corneel Heymanslaan, 10, Ghent, Belgium.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'De Craemer', 'Affiliation': 'Department of Rehabilitation Sciences, Ghent University, Corneel Heysmanslaan, 10, Ghent, Belgium.'}, {'ForeName': 'Odysseas', 'Initials': 'O', 'LastName': 'Androutsos', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Sciences & Education, Harokopio University, El. Venizelou 70, Kallithea, Athens, Greece.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wikström', 'Affiliation': 'Department of Public Health Solutions, National Institute for Health and Welfare, Mannerheimintie, 166, Helsinki, Finland.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Makrilakis', 'Affiliation': 'First Department of Propaedeutic Internal Medicine, National and Kapodistrian University of Athens, 75 Mikras Asias str, Athens, Greece.'}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Moreno', 'Affiliation': 'Growth, Exercise, Nutrition and Development (GENUD) Research Group, Instituto Agroalimentario de Aragón (IA2), Instituto de Investigación Sanitaria Aragón (IIS Aragón), University of Zaragoza, Calle Pedro Cerbuna, 12, Zaragoza, Spain.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Iotova', 'Affiliation': 'Department of Paediatrics, Medical University of Varna, 55 Marin Drinov str, Varna, Bulgaria.'}, {'ForeName': 'Tsvetalina', 'Initials': 'T', 'LastName': 'Tankova', 'Affiliation': 'Clinical Center of Endocrinology, Medical University of Sofia, Boulevard ""Akademik Ivan Evstratiev Geshov, 15, Sofia, Bulgaria.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nánási', 'Affiliation': 'Department of Family and Occupational Medicine, University of Debrecen, Egyeterm tér 1, Debrecen, Hungary.'}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Manios', 'Affiliation': 'Department of Nutrition and Dietetics, School of Health Sciences & Education, Harokopio University, El. Venizelou 70, Kallithea, Athens, Greece.'}, {'ForeName': 'Greet', 'Initials': 'G', 'LastName': 'Cardon', 'Affiliation': 'Department of Movement and Sport Sciences, Ghent University, Watersportlaan 2, 9000, Ghent, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC public health,['10.1186/s12889-020-09336-7']
1902,32788001,Radiotherapy Activates Matrix Metalloproteinases in the Dentinoenamel Junction of Primary Teeth.,"Purpose:  Radiation-related caries is characterized by enamel delamination near the dentinoenamel junction (DEJ). We investigated the activity and expression of the matrix metalloproteinases (MMPs) -2 and -9 in order to understand disease pathogenesis in teeth submitted or not to radiotherapy (RT).<br/>  Methods:  In situ zymography and immunofluorescence assays were performed to evaluate the activity and expression of MMPs -2 and -9, respectively. Twelve primary second molars were randomly assigned into two experimental subgroups: irradiated and nonirradiated. Dental fragments were exposed to radiation at a dose fraction of two Gy for five consecutive days until reaching the total dose of 60 Gy. The percentage of fluorescence in the DEJ was evaluated in three distinct regions of the tooth (cervical, cusp, and pit). The regions were photographed under fluorescence microscopy at 1.25× and 5× magnification.<br/>  Results:  The intensity of fluorescence per mm 2 in the DEJ was higher in the cervical region of irradiated primary teeth ( P  <0.05) versus nonirradiated ones. In these areas, immunofluorescence revealed expression of MMPs -2 and -9.<br/>  Conclusion:  Radiotherapy can increase the activity of MMPs -2 and -9 in the cervical region of the DEJ of primary teeth.",2020,The intensity of fluorescence per mm 2 in the DEJ was higher in the cervical region of irradiated primary teeth ( P  <0.05) versus nonirradiated ones.,['Twelve primary second molars'],['Radiotherapy'],"['percentage of fluorescence in the DEJ', 'intensity of fluorescence']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.0314919,The intensity of fluorescence per mm 2 in the DEJ was higher in the cervical region of irradiated primary teeth ( P  <0.05) versus nonirradiated ones.,"[{'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Queiroz', 'Affiliation': 'Dr. Queiroz, Department of Pediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil;, Email: amqueiroz@forp.usp.br.'}, {'ForeName': 'Claudia M', 'Initials': 'CM', 'LastName': 'Carpio-Bonilla', 'Affiliation': 'Dr. Carpio-Bonilla, Professor, Department of Pediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Maya F M', 'Initials': 'MFM', 'LastName': 'Arnez', 'Affiliation': 'Dr. Arnez, Research fellow, Department of Pediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Thais T', 'Initials': 'TT', 'LastName': 'Dos Santos', 'Affiliation': 'Santos, Graduate student, Department of Pediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Regina G', 'Initials': 'RG', 'LastName': 'Palma-Dibb', 'Affiliation': 'Dr. Palma-Dibb is a professor, Department of Restorative Dentistry, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Harley F', 'Initials': 'HF', 'LastName': 'Oliveira', 'Affiliation': 'Dr. Oliveira is a radiotherapist, Radio-Oncology Treatment Center, Ribeirão Preto, and at Marcio Cunha Hospital, Ipatinga, Minas Gerais, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Nelson-Filho', 'Affiliation': 'Dr. Nelson-Filho, Professor and Dean, Department of Pediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Lea A B', 'Initials': 'LAB', 'LastName': 'Silva', 'Affiliation': 'Silva, Professor, Department of Pediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}, {'ForeName': 'Francisco W G', 'Initials': 'FWG', 'LastName': 'Paula-Silva', 'Affiliation': 'Dr. Paula-Silva is an associate professor, Department of Pediatric Clinics, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, São Paulo, Brazil.'}]","Journal of dentistry for children (Chicago, Ill.)",[]
1903,32788149,Technology-Based Stepped Care to Stem Transgender Adolescent Risk Transmission: Protocol for a Randomized Controlled Trial (TechStep).,"BACKGROUND


Transgender youth demonstrate significantly higher rates of engagement in sexual risk behaviors relative to their cisgender or gender-conforming counterparts, including high rates of condomless anal intercourse and engagement in sex work. In addition, transgender youth experience increased physical or sexual abuse, victimization, substance use, mental health disorders, incarceration, and homelessness. Owing to these syndemic health disparities, transgender youth are at substantially increased risk of HIV infection.
OBJECTIVE


This protocol aims to describe a randomized controlled trial (RCT), Adolescent Medicine Trials Network 160 TechStep (N=250), which assesses the differential immediate and sustained effects of each of 3 conditions (text messaging, WebApp, or information-only control) for reducing sexual risk behaviors and increasing pre-exposure prophylaxis (PrEP) uptake among high-risk, HIV-negative transgender youth and young adults (aged 15-24 years).
METHODS


Participants will be recruited through web-based (targeted social media sites and apps) and offline (print ads and flyers) advertisements, peer and clinic referrals, and street- and venue-based outreach, and by contacting potential participants who have requested contact for future studies. Participants will be randomized into 1 of the 3 conditions: (1) text messaging, (2) WebApp, or (3) information-only control for 6 months. Assessments will occur at baseline and at 3, 6, and 9 months. Participants who do not show improvements in sexual risk or PrEP uptake at the 3-month assessment will be rerandomized to receive weekly electronic coaching (eCoaching) sessions in addition to their assigned text messaging or WebApp intervention, or remain in the original text messaging or WebApp intervention using a 2:1 ratio. Participants originally assigned to the information-only condition are not eligible for rerandomization.
RESULTS


Funding for TechStep was awarded in June 2017. Phase 1 was approved by the Institutional Review Board (IRB) in April 2018. Recruitment began in November 2018 for phase 1, the formative phase. Initial phase 2 IRB approval came in June 2019. The data collection for phase 2, the RCT, is expected to be completed in April 2021. As of March 2020, 54 participants have been enrolled in TechStep. The final results are anticipated in May 2021.
CONCLUSIONS


By providing culturally responsive, technology-based interventions, TechStep aims to improve sexual health outcomes among HIV-negative transgender youth and young adults at high risk of HIV. TechStep will evaluate the efficacy of technology-based interventions for reducing HIV sexual risk behaviors and increasing PrEP initiation, adherence, and persistence. The suite of technology-based interventions developed in TechStep, and assessed for efficacy in a 3-condition RCT, represents an important advancement in intervention science toward developing tailored and scalable interventions for transgender youth and young adults.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04000724; http://clinicaltrials.gov/ct2/show/NCT04000724.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18326.",2020,"TechStep will evaluate the efficacy of technology-based interventions for reducing HIV sexual risk behaviors and increasing PrEP initiation, adherence, and persistence.","['to Stem Transgender Adolescent Risk Transmission', 'transgender youth and young adults', 'Participants will be recruited through web-based (targeted social media sites and apps) and offline (print ads and flyers) advertisements, peer and clinic referrals, and street- and venue-based outreach, and by contacting potential participants who have requested contact for future studies', 'high-risk, HIV-negative transgender youth and young adults (aged 15-24 years', '54 participants have been enrolled in TechStep', 'HIV-negative transgender youth and young adults at high risk of HIV']","['Technology-Based Stepped Care', 'By providing culturally responsive, technology-based interventions', '3 conditions (text messaging, WebApp, or information-only control) for reducing sexual risk behaviors and increasing pre-exposure prophylaxis (PrEP) uptake', 'electronic coaching (eCoaching) sessions in addition to their assigned text messaging or WebApp intervention, or remain in the original text messaging or WebApp intervention', 'text messaging, (2) WebApp, or (3) information-only control for 6 months']","['physical or sexual abuse, victimization, substance use, mental health disorders, incarceration, and homelessness', 'HIV sexual risk behaviors', 'sexual risk or PrEP uptake', 'sexual health outcomes']","[{'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0442658', 'cui_str': 'Street'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0282350', 'cui_str': 'Sexual abuse'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0205255', 'cui_str': 'Imprisonment'}, {'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.123827,"TechStep will evaluate the efficacy of technology-based interventions for reducing HIV sexual risk behaviors and increasing PrEP initiation, adherence, and persistence.","[{'ForeName': 'Cathy J', 'Initials': 'CJ', 'LastName': 'Reback', 'Affiliation': 'Friends Research Institute, Inc, Los Angeles, CA, United States.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Rusow', 'Affiliation': 'Friends Research Institute, Inc, Los Angeles, CA, United States.'}, {'ForeName': 'Demetria', 'Initials': 'D', 'LastName': 'Cain', 'Affiliation': 'PRIDE Health Research Consortium, Hunter College, City University of New York, New York, NY, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Benkeser', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Arayasirikul', 'Affiliation': 'Department of Pediatrics, Division of Developmental Medicine, University of California, San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hightow-Weidman', 'Affiliation': 'Institute for Global Health and Infectious Diseases, The University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Horvath', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, CA, United States.'}]",JMIR research protocols,['10.2196/18326']
1904,32788190,Transmission reduction and prevention with HPV vaccination (TRAP-HPV) study protocol: a randomised controlled trial of the efficacy of HPV vaccination in preventing transmission of HPV infection in heterosexual couples.,"INTRODUCTION


Human papillomavirus (HPV) is a causal agent of malignancies including cervical, vulvar, vaginal, penile, anal and oropharyngeal cancer, as well as benign conditions such as anogenital warts. HPV vaccination protects individuals against infections with the target HPV types and their clinical outcomes. However, little is known about the protection an immunised individual confers to their sexual partner or its impact on HPV transmission dynamics. In this context, the Transmission Reduction and Prevention with HPV vaccination (TRAP-HPV) study was designed to determine the efficacy of an HPV vaccine in reducing transmission of genital and oral HPV infection in sexual partners of vaccinated individuals.
METHODS AND ANALYSIS


The TRAP-HPV study is an ongoing randomised controlled trial among heterosexual couples living in Montreal, Canada. Sexually active couples, aged between 18 and 45 years, who have been in a relationship no longer than 6 months are considered eligible. Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention-intervention, intervention-placebo, placebo-intervention and the placebo-placebo. Participants provide genital (vaginal/penile) and oral samples at baseline and five follow-up visits over a 1-year duration. Linear Array HPV genotyping is used to detect 36 HPV types. Cox proportional hazard regression models will be used to estimate the effect of vaccination on HPV transmission.
ETHICS AND DISSEMINATION


The TRAP-HPV study received ethical approval by institutional review boards McGill University, Concordia University and Centre Hospitalier de l'Université de Montréal. Before enrolment, all participants provide informed written consent. Results will be published in peer-reviewed journals and presented at national and international conferences. The generated empirical evidence could be used in mathematical models of vaccination to inform policymakers in Canada and elsewhere.
TRIAL REGISTRATION NUMBER


NCT01824537.",2020,"Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention-intervention, intervention-placebo, placebo-intervention and the placebo-placebo.","['heterosexual couples living in Montreal, Canada', 'sexual partners of vaccinated individuals', 'heterosexual couples', 'Sexually active couples, aged between 18 and 45 years, who have been in a relationship no longer than 6 months are considered eligible']","['HPV vaccination (TRAP-HPV', 'intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention-intervention, intervention-placebo, placebo-intervention and the placebo-placebo', 'HPV vaccination', 'HPV vaccine']",['transmission of genital and oral HPV infection'],"[{'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0241028', 'cui_str': 'Sexually active'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C1275126', 'cui_str': 'TNF receptor-associated periodic fever syndrome (TRAPS)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1512511', 'cui_str': 'Human papillomavirus vaccine'}, {'cui': 'C3864947', 'cui_str': 'Gardasil 9'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0170300', 'cui_str': 'Hepatitis A Vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0343641', 'cui_str': 'Human papilloma virus infection'}]",,0.257928,"Participants are independently randomised to receive either the intervention HPV vaccine, Gardasil 9, or a placebo hepatitis A vaccine, Avaxim, creating four vaccination groups among couples: intervention-intervention, intervention-placebo, placebo-intervention and the placebo-placebo.","[{'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'MacCosham', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'El-Zein', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Ann N', 'Initials': 'AN', 'LastName': 'Burchell', 'Affiliation': ""Department of Family and Community Medicine and Centre for Research on Inner City Health, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Pierre-Paul', 'Initials': 'PP', 'LastName': 'Tellier', 'Affiliation': 'Family Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Coutlée', 'Affiliation': ""Service de Microbiologie Médicale et Service d'Infectiologie, Départements de Médecine et de Médecine de Laboratoire, Centre Hospitalier de L'Universite de Montreal, Montreal, Quebec, Canada.""}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Franco', 'Affiliation': 'Division of Cancer Epidemiology, McGill University, Montreal, Quebec, Canada eduardo.franco@mcgill.ca.'}]",BMJ open,['10.1136/bmjopen-2020-039383']
1905,32789215,Training with an Electric Exercise Bike versus a Conventional Exercise Bike during Hemodialysis for Patients with End-stage Renal Disease: A Randomized Clinical Trial.,"Objective


Hemodialysis (HD) patients have lower fitness levels than healthy subjects because of various structural, metabolic, and functional abnormalities secondary to uremic changes in skeletal muscles. Aerobic and resistance exercises are beneficial in improving not only physical function, including maximal oxygen uptake and muscle strength, but also anthropometrics, nutritional status, and hematologic indices. The use of electric ergometers that place light loads on patients has been implemented at many dialysis facilities in Japan. However, reports comparing the effects on body function of electric and variable-load ergometers are few. This study aimed to compare electric ergometers and variable-load ergometers in terms of exercise outcomes in HD patients.
Methods


A total of 15 ambulatory HD patients were randomly divided into two groups: the variable-load ergometer group (n=8) and the electric ergometer group (n=7). HD patients exercised at a level based on their physical function three times a week for 12 weeks.
Results


After the 12-week intervention period, only the variable-load ergometer group experienced significant increases in lower extremity muscle strength and exercise tolerance.
Conclusion


This study confirmed that conventional aerobic training and electric bike exercise during HD were efficacious and safe without causing sudden hypotension or any other side effects. However, exercise using a variable-load ergometer may be more effective than exercise using an electric bike in improving the physical function of HD patients. Exercise using a variable-load ergometer elicited specific whole-body and local effects.",2017,"After the 12-week intervention period, only the variable-load ergometer group experienced significant increases in lower extremity muscle strength and exercise tolerance.
","['HD patients', '15 ambulatory HD patients', 'Patients with End-stage Renal Disease']","['electric ergometer group', 'conventional aerobic training and electric bike exercise', 'variable-load ergometer group', 'Aerobic and resistance exercises', 'Training with an Electric Exercise Bike versus a Conventional Exercise Bike during Hemodialysis']","['lower extremity muscle strength and exercise tolerance', 'maximal oxygen uptake and muscle strength']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0392218', 'cui_str': 'Bicycle exerciser'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",15.0,0.0131777,"After the 12-week intervention period, only the variable-load ergometer group experienced significant increases in lower extremity muscle strength and exercise tolerance.
","[{'ForeName': 'Misa', 'Initials': 'M', 'LastName': 'Miura', 'Affiliation': 'Tsukuba University of Technology, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Yoshizawa', 'Affiliation': 'Asao Clinic, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Oowada', 'Affiliation': 'Asao Clinic, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Aki', 'Initials': 'A', 'LastName': 'Hirayama', 'Affiliation': 'Tsukuba University of Technology, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ito', 'Affiliation': 'Northeast Medical Pharmaceutical University, Sendai, Miyagi, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kohzuki', 'Affiliation': 'Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Maeba', 'Affiliation': 'Asao Clinic, Kawasaki, Kanagawa, Japan.'}]",Progress in rehabilitation medicine,['10.2490/prm.20170008']
1906,32789241,Safety and Feasibility of Dual-task Rehabilitation Program for Body Trunk Balance Using Virtual Reality and Three-dimensional Tracking Technologies.,"Objective


The ability to walk is one of the most important basic functional activities of daily living, and the number of patients with walking disability who need rehabilitation is increasing worldwide. The purpose of this first-in-man study was to evaluate the safety and feasibility of an off-label, tailor-made, dual-task rehabilitation program for body trunk balance using the mediVR01 system (mediVR, Inc. Osaka, Japan), which incorporates virtual reality (VR) and three-dimensional tracking technologies.
Methods


We prospectively enrolled 31 healthy volunteers to take part in the trial (Trial Registration UMIN000029659). After an assessment of body trunk balance, a tailor-made, dual-task, rehabilitation training program lasting 10-15 min was provided. The primary endpoint was the postprocedural number of simulator sickness questionnaire (SSQ) symptoms. The secondary endpoints were adverse events and satisfaction with the program.
Results


The median age of participants was 68 years, with 67.7% being elderly (>65 years) and 54.8% being male. The number of SSQ symptoms immediately after the rehabilitation programs significantly increased from 0 (interquartile range 0-0) to 0 (0-1.5) (P=0.009), with a significant difference between the young and elderly participants (P-interaction<0.001). The most frequent symptom was sweating (22.6%), followed by fatigue (19.4%). All participants successfully completed the rehabilitation programs without significant adverse events such as fall or injuries. Moreover, all participants considered the VR rehabilitation programs to be enjoyable, and 93.5% of participants reported a sense of achievement. Group attendance was associated with higher levels of satisfaction (P=0.049).
Conclusion


The tailor-made, dual-task rehabilitation training programs for body trunk balance using VR and three-dimensional tracking technologies were safe and feasible even for elderly participants.",2018,"Group attendance was associated with higher levels of satisfaction (P=0.049).
","['31 healthy volunteers', 'elderly participants', 'The median age of participants was 68 years, with 67.7% being elderly (>65 years) and 54.8% being male']","['Dual-task Rehabilitation Program', 'label, tailor-made, dual-task rehabilitation program']","['postprocedural number of simulator sickness questionnaire (SSQ) symptoms', 'number of SSQ symptoms', 'adverse events such as fall or injuries', 'levels of satisfaction', 'adverse events and satisfaction with the program']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",31.0,0.0232883,"Group attendance was associated with higher levels of satisfaction (P=0.049).
","[{'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Hara', 'Affiliation': 'Center for Community-based Healthcare Research and Education, Shimane University, Izumo, Japan.'}, {'ForeName': 'Tetsuhisa', 'Initials': 'T', 'LastName': 'Kitamura', 'Affiliation': 'Division of Environmental Medicine and Population Sciences, Department of Social and Environmental Medicine, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Murakawa', 'Affiliation': 'Division of Stroke Rehabilitation, National Cerebral and Cardiovascular Center Hospital, Suita, Japan.'}, {'ForeName': 'Kyosuke', 'Initials': 'K', 'LastName': 'Shimba', 'Affiliation': 'Department of Medical Device Development, mediVR, Inc., Osaka, Japan.'}, {'ForeName': 'Shimpei', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Medical Device Development, mediVR, Inc., Osaka, Japan.'}, {'ForeName': 'Masatake', 'Initials': 'M', 'LastName': 'Tamaki', 'Affiliation': 'Department of Medical Device Development, mediVR, Inc., Osaka, Japan.'}]",Progress in rehabilitation medicine,['10.2490/prm.20180016']
1907,32789251,Effect of the Management Tool for Daily Life Performance on Patients with Cardiovascular Disease: A Randomized Controlled Trial.,"Objective


Cardiovascular diseases cause psychological symptoms, such as depression and anxiety. Symptoms of depression have a major effect on patients and worsen prognosis as a result of reduced quality of life and decreased levels of physical activity. Because cardiac rehabilitation (CR) has physical, mental, and secondary preventative effects, it is necessary to evaluate the psychological factors of patients and to provide patients with psychological support based on the results. The management tool for daily life performance (MTDLP) was developed in 2006 by the Japanese Association of Occupational Therapists. Since then, its effectiveness for patients with cerebrovascular diseases and bone fractures has been verified. However, no randomized controlled trial has been conducted on the effectiveness of interventions using MTDLP on patients with cardiovascular diseases.
Methods


We examined the effectiveness of intervention using MTDLP on patients undergoing outpatient CR. Thirty-six patients who scored at least 48 on the self-rating depression scale (SDS) were included in the study. Eighteen patients were allocated to both the CR and MTDLP groups. The SDS, Barthel index, Frenchay Activities Index (FAI), and Life-Space Assessment were evaluated as outcome measures.
Results


The CR group (n=14) showed significantly improved post-intervention scores on the SDS (P=0.007). Furthermore, the MTDLP group (n=11) showed significantly improved post-intervention scores on the SDS (P=0.010) and FAI (P=0.003).
Conclusions


CR improves depression, whereas additional intervention using MTDLP improves not only depression but also various daily activities. Consequently, intervention using MTDLP in CR appears to be effective.",2019,The CR group (n=14) showed significantly improved post-intervention scores on the SDS (P=0.007).,"['patients with cerebrovascular diseases and bone fractures', 'patients undergoing outpatient CR', 'Eighteen patients', '2006 by the Japanese Association of Occupational Therapists', 'Patients with Cardiovascular Disease', 'patients with cardiovascular diseases', 'Thirty-six patients who scored at least 48 on the self-rating depression scale (SDS) were included in the study']",['MTDLP'],"['SDS, Barthel index, Frenchay Activities Index (FAI), and Life-Space Assessment', 'post-intervention scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0028807', 'cui_str': 'Occupational therapist'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",18.0,0.0387807,The CR group (n=14) showed significantly improved post-intervention scores on the SDS (P=0.007).,"[{'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Fukui', 'Affiliation': 'Department of Rehabilitation, Nara Prefectural Seiwa Medical Center, Nara, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Yoshida', 'Affiliation': 'Department of Rehabilitation, Nara Prefectural Seiwa Medical Center, Nara, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Higaki', 'Affiliation': 'Department of Community Health, Osaka Prefectural University, Osaka, Japan.'}]",Progress in rehabilitation medicine,['10.2490/prm.20190004']
1908,32789276,Preventive Effects of Repetitive Peripheral Magnetic Stimulation on Muscle Atrophy in the Paretic Lower Limb of Acute Stroke Patients: A Pilot Study.,"Objective


The aim of this study was to investigate the effect of repetitive peripheral magnetic stimulation (rPMS) on muscle atrophy prevention in the rectus femoris muscle (RF) of the paretic limb in acute stroke patients.
Methods


Twelve acute stroke patients with a National Institute of Health Stroke Scale score >5 and a motor score of the paretic lower limb >2 at admission were divided into an intervention group (rPMS: mean age, 75±6.4 years) and a conventional care group (non-rPMS: mean age, 62±11.8 years). Baseline measurements were performed within 4 days of stroke onset. In the rPMS group, treatment was applied to the paretic thigh only for 2 weeks, 5 days a week, in addition to conventional care. The cross-sectional area (CSA) of the RF was assessed in both limbs using ultrasound at baseline and 2 weeks later. Data on patient characteristics were collected from the clinical records to assess correlations with the CSA rate of change.
Results


Patients in the rPMS group were significantly older. Although the CSA of the RF did not change significantly on either side in the rPMS group, there was a significant decrease in the CSA on the paretic side in the non-rPMS group. However, no significant difference was observed in the CSA rate of change in the rPMS and non-rPMS groups. The CSA rate of change on the paretic side correlated negatively with age in the rPMS group.
Conclusions


Our results suggest that rPMS prevents muscle atrophy more effectively in patients in their 60s than in patients more than 70 years old.",2020,"However, no significant difference was observed in the CSA rate of change in the rPMS and non-rPMS groups.","['Acute Stroke Patients', 'acute stroke patients', 'Twelve acute stroke patients with a National Institute of Health Stroke Scale score >5 and a motor score of the paretic lower limb >2 at admission were divided into an intervention group (rPMS: mean age, 75±6.4 years) and a conventional care group (non-rPMS: mean age, 62±11.8 years']","['repetitive peripheral magnetic stimulation (rPMS', 'Repetitive Peripheral Magnetic Stimulation', 'rPMS']","['CSA rate', 'CSA rate of change', 'CSA rate of change on the paretic side']","[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439084', 'cui_str': '>5'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0249341,"However, no significant difference was observed in the CSA rate of change in the rPMS and non-rPMS groups.","[{'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Department of Public Health, Graduate School of Advanced Preventive Medical Sciences, Kanazawa University, Kanazawa, Ishikawa, Japan.'}, {'ForeName': 'Tomotaka', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Science and Technology, Kawasaki University of Medical Welfare, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Okada', 'Affiliation': 'Rehabilitation Center, Kawasaki Medical School Hospital, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Hiraoka', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Science and Technology, Kawasaki University of Medical Welfare, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Kozo', 'Initials': 'K', 'LastName': 'Hanayama', 'Affiliation': 'Department of Rehabilitation Medicine, Kawasaki Medical School, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Tsubahara', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Science and Technology, Kawasaki University of Medical Welfare, Kurashiki, Okayama, Japan.'}]",Progress in rehabilitation medicine,['10.2490/prm.20200008']
1909,32784117,Idebenone does not inhibit disability progression in primary progressive MS.,"BACKGROUND


Multiple sclerosis (MS) is a chronic, immune-mediated neurodegenerative disorder of the central nervous system (CNS). While current MS therapies target the inflammatory processes, no treatment explicitly targets mitochondrial dysfunction and resulting axonal loss. Therefore, the aim of this study was to determine whether idebenone inhibits mitochondrial dysfunction and accumulation of disability in primary progressive MS (PPMS) and to enhance understanding of pathogenic mechanisms of PPMS progression using cerebrospinal fluid (CSF) biomarkers.
METHODS


The double-blind, placebo-controlled Phase I/II clinical trial of Idebenone in patients with Primary Progressive MS (IPPoMS; NCT00950248) was an adaptively designed, baseline-versus-treatment, placebo-controlled, CSF-biomarker-supported trial. Based on interim analysis of the 1-year pre-treatment data, change in the area under the curve of Combinatorial Weight-Adjusted Disability Score (CombiWISE) became the primary outcome, with >80% power to detect ≥40% efficacy with 28 patients/arm treated for 2 years in baseline versus treatment paradigm. Changes in traditional disability scales and in brain ventricular volume were secondary outcomes. Exploratory outcomes included CSF biomarkers of mitochondrial dysfunction (Growth/differentiation factor 15 [GDF15] and lactate), axonal damage (neurofilament light chain [NFL]), innate immunity (sCD14), blood brain barrier leakage (albumin quotient) and retinal nerve fiber layer thinning.
RESULTS


Idebenone was well tolerated but did not inhibit disability progression or CNS tissue destruction. Concentrations of GDF15, secreted predominantly by astrocytes and choroid plexus epithelium in vitro, increased after exposure to mitochondrial toxin rotenone, validating the ability of this biomarker to measure intrathecal mitochondrial damage. CSF GDF15 levels correlated strongly with age and MS patients had CSF levels of GDF15 significantly above age-adjusted healthy volunteers, with highest levels measured in PPMS. Idebenone did not change CSF GDF15 levels.
CONCLUSION


Mitochondrial dysfunction exceeding normal aging reflected by age-adjusted CSF GDF15 is present in the majority of PPMS patients, but it is not inhibited by idebenone.",2020,"CSF GDF15 levels correlated strongly with age and MS patients had CSF levels of GDF15 significantly above age-adjusted healthy volunteers, with highest levels measured in PPMS.","['patients with Primary Progressive MS (IPPoMS', 'primary progressive MS (PPMS']","['Idebenone', 'idebenone', 'placebo']","['Mitochondrial dysfunction', 'traditional disability scales', 'CSF levels of GDF15', 'CSF biomarkers of mitochondrial dysfunction (Growth/differentiation factor 15 [GDF15] and lactate), axonal damage (neurofilament light chain [NFL]), innate immunity (sCD14), blood brain barrier leakage (albumin quotient) and retinal nerve fiber layer thinning', 'CSF GDF15 levels', 'Combinatorial Weight-Adjusted Disability Score (CombiWISE', 'disability progression or CNS tissue destruction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751964', 'cui_str': 'Primary progressive multiple sclerosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0123163', 'cui_str': 'idebenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1431343', 'cui_str': 'GDF15 protein, human'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0027834', 'cui_str': 'Neurofilaments'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0020969', 'cui_str': 'Innate Immunity'}, {'cui': 'C0005854', 'cui_str': 'Brain-Blood Barrier'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1261381', 'cui_str': 'Destructive procedure'}]",,0.0721347,"CSF GDF15 levels correlated strongly with age and MS patients had CSF levels of GDF15 significantly above age-adjusted healthy volunteers, with highest levels measured in PPMS.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kosa', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Tianxia', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Clinical trials Unit, National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Phillips', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Leinonen', 'Affiliation': 'Santhera Pharmaceuticals (Switzerland) AG, Pratteln Switzerland.'}, {'ForeName': 'Ruturaj', 'Initials': 'R', 'LastName': 'Masvekar', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Komori', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Wichman', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sandford', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bibiana', 'Initials': 'B', 'LastName': 'Bielekova', 'Affiliation': 'Neuroimmunological Diseases Section, Laboratory of Clinical Immunology and Microbiology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. Electronic address: Bibi.Bielekova@nih.gov.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102434']
1910,32784153,Optimizing Testing for BPPV - The Loaded Dix-Hallpike.,"OBJECTIVES


Although the Dix-Hallpike testing is generally considered as the gold standard for the identification of the posterior canal benign paroxysmal positional vertigo (BPPV), we investigated a modification of the maneuver termed the ""loaded Dix-Hallpike.""
STUDY DESIGN


Prospective randomized controlled trial.
MATERIALS AND METHODS


Twenty-eight patients participated in this prospective study comparing the standard Dix-Hallpike (S-DH) to the loaded Dix-Hallpike (L-DH) test. Each patient underwent repeated testing with the S-DH and the L-DH. The patients were placed into two groups. Fourteen patients underwent 3 rounds of S-DH testing followed by 3 rounds of L-DH testing. The other fourteen patients underwent 3 rounds of L-DH testing followed by 3 rounds of S-DH testing. The duration of nystagmus and the latency prior to the onset of nystagmus were measured for each test. Additionally, the patients were asked to rate the severity of their symptoms following each test.
RESULTS


The duration of nystagmus of the L-DH was significantly longer than that of the S-DH (p<0.0001). The patients reported a higher severity score with L-DH as compared to with S-DH (p<0.001). The L-DH was found to be more sensitive than the S-DH (p=0.0131).
CONCLUSION


The L-DH produces significantly longer duration of nystagmus, stronger symptoms, and improved sensitivity when compared to the S-DH.",2020,"The L-DH was found to be more sensitive than the S-DH (p=0.0131).
","['posterior canal benign paroxysmal positional vertigo (BPPV', 'Twenty-eight patients participated']",['standard Dix-Hallpike (S-DH) to the loaded Dix-Hallpike (L-DH) test'],"['duration of nystagmus of the L-DH', 'duration of nystagmus, stronger symptoms, and improved sensitivity', 'duration of nystagmus and the latency prior to the onset of nystagmus']","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0155502', 'cui_str': 'Benign paroxysmal positional vertigo'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0028738', 'cui_str': 'Nystagmus'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}]",28.0,0.0195251,"The L-DH was found to be more sensitive than the S-DH (p=0.0131).
","[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Andera', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Geisinger Medical Center, Pennsylvania, USA.'}, {'ForeName': 'William James', 'Initials': 'WJ', 'LastName': 'Azeredo', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Geisinger Medical Center, Pennsylvania, USA.'}, {'ForeName': 'Joseph Scott', 'Initials': 'JS', 'LastName': 'Greene', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Geisinger Medical Center, Pennsylvania, USA.'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Biomedical and Translational Informatics, Geisinger Medical Center, Pennsylvania, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Geisinger Medical Center, Pennsylvania, USA.'}]",The journal of international advanced otology,['10.5152/iao.2020.7444']
1911,32784157,The Efficacy of Intratympanic Steroid Injection in Tinnitus Cases Unresponsive to Medical Treatment.,"OBJECTIVES


To examine the efficacy of an intratympanic steroid injection in tinnitus cases unresponsive to medical treatment.
MATERIALS AND METHODS


The study was carried out at the Ear, Nose, and Throat Department with 107 patients (46 male, 61 female) between the ages of 20 and 77 with a mean of 42.8 years who had idiopathic tinnitus. Patients were randomized by simple randomization to receive intratympanic dexamethasone or isotonic solution. The patients received six intratympanic injections, two per week for three weeks. Tinnitus handicap index (THI) was performed before treatment and at first week, first month, and six months after the completion of the study protocol. The audiometric tests were performed six months after the treatment.
RESULT


In the study group, pretreatment THI and post-treatment first month THI scores and pretreatment THI and post-treatment sixth month THI scores were significantly different whereas the same scores were not significantly different in the control group. The comparison of THI scores between the groups revealed significantly lower scores in the first and sixth months for the study group.
CONCLUSION


The effect of the intratympanic injection of dexamethasone on the efficacy of treatment of tinnitus severity was statistically significant.",2020,"The comparison of THI scores between the groups revealed significantly lower scores in the first and sixth months for the study group.
","['Tinnitus Cases Unresponsive to Medical Treatment', 'Ear, Nose, and Throat Department with 107 patients (46 male, 61 female) between the ages of 20 and 77 with a mean of 42.8 years who had idiopathic tinnitus', 'tinnitus cases unresponsive to medical treatment']","['dexamethasone', 'intratympanic steroid injection', 'Intratympanic Steroid Injection', 'intratympanic dexamethasone or isotonic solution']","['THI scores and pretreatment THI and post-treatment sixth month THI scores', 'Tinnitus handicap index (THI', 'THI scores', 'tinnitus severity']","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1517566', 'cui_str': 'Intratympanic route'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0022260', 'cui_str': 'Isotonic Solutions'}]","[{'cui': 'C0040264', 'cui_str': 'Tinnitus'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",107.0,0.0149494,"The comparison of THI scores between the groups revealed significantly lower scores in the first and sixth months for the study group.
","[{'ForeName': 'Haydar Murat', 'Initials': 'HM', 'LastName': 'Yener', 'Affiliation': 'Department of Otorhinolaryngology, İstanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Sarı', 'Affiliation': 'Department of Otorhinolaryngology, İstanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Aslan', 'Affiliation': 'Department of Otorhinolaryngology, İstanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Umur', 'Initials': 'U', 'LastName': 'Yollu', 'Affiliation': 'Department of Otorhinolaryngology, İstanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Emine Deniz', 'Initials': 'ED', 'LastName': 'Gözen', 'Affiliation': 'Department of Otorhinolaryngology, İstanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Ender', 'Initials': 'E', 'LastName': 'İnci', 'Affiliation': 'Department of Otorhinolaryngology, İstanbul University-Cerrahpaşa, Cerrahpaşa School of Medicine, İstanbul, Turkey.'}]",The journal of international advanced otology,['10.5152/iao.2020.7588']
1912,32784162,"Comparison between Fluoroplastic and Platinum/Titanium Piston in Stapedotomy: A Prospective, Randomized Clinical Study.","OBJECTIVES


The objective of this study was to compare hearing results of fluoroplastic (Teflon) Causse Loop Piston with platinum/titanium (Big Easy) Piston in patients who underwent stapedotomy due to otosclerosis.
MATERIALS AND METHODS


In this prospective randomized clinical trial study, Causse Loop Piston prosthesis was used in 76 ears and the Big Easy Piston prosthesis in 72 ears. The main outcomes were preoperative and postoperative pure tone audiometry and air-bone gap (ABG).
RESULTS


Postoperative ABG closure was not significantly different between both groups. However, the Causse Loop Piston resulted in a significant improvement of the air conduction (AC) in frequencies of 250, 500, and 1,000 Hz. In addition, the improvement of speech reception threshold (SRT) was significantly higher in Causse Loop Piston group.
CONCLUSION


We achieved similar postoperative ABG closure in short-term with both prostheses. However, at low frequencies, AC gain was higher in Causse Loop Piston group. In addition, patients in this group yielded better SRT.",2020,"In addition, the improvement of speech reception threshold (SRT) was significantly higher in Causse Loop Piston group.
","['76 ears and the Big Easy Piston prosthesis in 72 ears', 'Stapedotomy', 'patients who underwent stapedotomy due to otosclerosis']","['Causse Loop Piston with platinum/titanium (Big Easy) Piston', 'Fluoroplastic and Platinum/Titanium Piston', 'Causse Loop Piston prosthesis']","['air conduction (AC', 'AC gain', 'preoperative and postoperative pure tone audiometry and air-bone gap (ABG', 'SRT', 'Postoperative ABG closure', 'postoperative ABG closure', 'speech reception threshold (SRT', 'hearing results of fluoroplastic (Teflon']","[{'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0441230', 'cui_str': 'Ossicular piston prosthesis'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0395740', 'cui_str': 'Small fenestra stapedectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0029899', 'cui_str': 'Otosclerosis'}]","[{'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0441230', 'cui_str': 'Ossicular piston prosthesis'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}]","[{'cui': 'C0234744', 'cui_str': 'Air conduction'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004292', 'cui_str': 'Pure tone audiometry'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}]",,0.083494,"In addition, the improvement of speech reception threshold (SRT) was significantly higher in Causse Loop Piston group.
","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Otolaryngology, Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sareh', 'Initials': 'S', 'LastName': 'Roosta', 'Affiliation': 'Department of Biostatistics, Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Daneshian', 'Affiliation': 'Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",The journal of international advanced otology,['10.5152/iao.2020.5129']
1913,32779626,Corrigendum*: Effects of Computer-based Stress Management Training on Psychological Well-being and Work Performance in Japanese Employees: A Cluster Randomized Controlled Trial.,"In Table 2, Mean and SD were opposite between the intervention group and the wait-list control group. In Table 3, there was a mistake in the annotation: the number of the intervention group was 142. The corrected Table 2 and Table 3 are presented below. We apologize for any inconvenience that this may have caused. *Important errors made by the author(s).",2020,"In Table 2, Mean and SD were opposite between the intervention group and the wait-list control group.",['Japanese Employees'],['Computer-based Stress Management Training'],['Psychological Well-being and Work Performance'],"[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C1286385', 'cui_str': 'Performance at work'}]",,0.0325394,"In Table 2, Mean and SD were opposite between the intervention group and the wait-list control group.","[{'ForeName': 'Rino', 'Initials': 'R', 'LastName': 'Umanodan', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Shimazu', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Japan.'}, {'ForeName': 'Masahide', 'Initials': 'M', 'LastName': 'Minami', 'Affiliation': 'Department of Public Health / Health Policy, The University of Tokyo, Japan.'}, {'ForeName': 'Norito', 'Initials': 'N', 'LastName': 'Kawakam', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Japan.'}]",Industrial health,['10.2486/indhealth.2013-0209c1']
1914,32780138,Effects of Liberal vs Restrictive Transfusion Thresholds on Survival and Neurocognitive Outcomes in Extremely Low-Birth-Weight Infants: The ETTNO Randomized Clinical Trial.,"Importance


Red blood cell transfusions are commonly administered to infants weighing less than 1000 g at birth. Evidence-based transfusion thresholds have not been established. Previous studies have suggested higher rates of cognitive impairment with restrictive transfusion thresholds.
Objective


To compare the effect of liberal vs restrictive red blood cell transfusion strategies on death or disability.
Design, Setting, and Participants


Randomized clinical trial conducted in 36 level III/IV neonatal intensive care units in Europe among 1013 infants with birth weights of 400 g to 999 g at less than 72 hours after birth; enrollment took place between July 14, 2011, and November 14, 2014, and follow-up was completed by January 15, 2018.
Interventions


Infants were randomly assigned to liberal (n = 492) or restrictive (n = 521) red blood cell transfusion thresholds based on infants' postnatal age and current health state.
Main Outcome and Measures


The primary outcome, measured at 24 months of corrected age, was death or disability, defined as any of cognitive deficit, cerebral palsy, or severe visual or hearing impairment. Secondary outcome measures included individual components of the primary outcome, complications of prematurity, and growth.
Results


Among 1013 patients randomized (median gestational age at birth, 26.3 [interquartile range {IQR}, 24.9-27.6] weeks; 509 [50.2%] females), 928 (91.6%) completed the trial. Among infants in the liberal vs restrictive transfusion thresholds groups, respectively, incidence of any transfusion was 400/492 (81.3%) vs 315/521 (60.5%); median volume transfused was 40 mL (IQR, 16-73 mL) vs 19 mL (IQR, 0-46 mL); and weekly mean hematocrit was 3 percentage points higher with liberal thresholds. Among infants in the liberal vs restrictive thresholds groups, the primary outcome occurred in 200/450 (44.4%) vs 205/478 (42.9%), respectively, for a difference of 1.6% (95% CI, -4.8% to 7.9%; P = .72). Death by 24 months occurred in 38/460 (8.3%) vs 44/491 (9.0%), for a difference of -0.7% (95% CI, -4.3% to 2.9%; P = .70), cognitive deficit was observed in 154/410 (37.6%) vs 148/430 (34.4%), for a difference of 3.2% (95% CI, -3.3% to 9.6%; P = .47), and cerebral palsy occurred in 18/419 (4.3%) vs 25/443 (5.6%), for a difference of -1.3% (95% CI, -4.2% to 1.5%; P = .37), in the liberal vs the restrictive thresholds groups, respectively. In the liberal vs restrictive thresholds groups, necrotizing enterocolitis requiring surgical intervention occurred in 20/492 (4.1%) vs 28/518 (5.4%); bronchopulmonary dysplasia occurred in 130/458 (28.4%) vs 126/485 (26.0%); and treatment for retinopathy of prematurity was required in 41/472 (8.7%) vs 38/492 (7.7%). Growth at follow-up was also not significantly different between groups.
Conclusions and Relevance


Among infants with birth weights of less than 1000 g, a strategy of liberal blood transfusions compared with restrictive transfusions did not reduce the likelihood of death or disability at 24 months of corrected age.
Trial Registration


ClinicalTrials.gov Identifier: NCT01393496.",2020,", a strategy of liberal blood transfusions compared with restrictive transfusions did not reduce the likelihood of death or disability at 24 months of corrected age.
","['infants weighing less than 1000 g at birth', 'infants with birth weights of less than 1000 g', '1013 patients randomized (median gestational age at birth, 26.3 [interquartile range {IQR}, 24.9-27.6] weeks; 509 [50.2%] females), 928 (91.6%) completed the trial', '36 level III/IV neonatal intensive care units in Europe among 1013 infants with birth weights of 400 g to 999 g at less than 72 hours after birth; enrollment took place between July 14, 2011, and November 14, 2014, and follow-up was completed by January 15, 2018', 'Extremely Low-Birth-Weight Infants']","[""liberal (n\u2009=\u2009492) or restrictive (n\u2009=\u2009521) red blood cell transfusion thresholds based on infants' postnatal age and current health state"", 'liberal vs restrictive red blood cell transfusion strategies', 'Liberal vs Restrictive Transfusion']","['likelihood of death or disability', 'Survival and Neurocognitive Outcomes', 'retinopathy of prematurity', 'death or disability', 'cognitive deficit', 'bronchopulmonary dysplasia', 'cerebral palsy', 'individual components of the primary outcome, complications of prematurity, and growth', 'mean hematocrit', 'necrotizing enterocolitis requiring surgical intervention', 'death or disability, defined as any of cognitive deficit, cerebral palsy, or severe visual or hearing impairment', 'incidence of any transfusion', 'Death']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C4517668', 'cui_str': '26.3'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C5191069', 'cui_str': '999'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0456065', 'cui_str': 'Extremely low birth weight infant'}]","[{'cui': 'C0086252', 'cui_str': 'Transfusion of red blood cells'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035344', 'cui_str': 'Retinopathy of prematurity'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1960452', 'cui_str': 'Complication of prematurity'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",1013.0,0.388986,", a strategy of liberal blood transfusions compared with restrictive transfusions did not reduce the likelihood of death or disability at 24 months of corrected age.
","[{'ForeName': 'Axel R', 'Initials': 'AR', 'LastName': 'Franz', 'Affiliation': ""Center for Pediatric Clinical Studies, University Children's Hospital Tübingen, Tübingen, Germany.""}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Engel', 'Affiliation': ""Center for Pediatric Clinical Studies, University Children's Hospital Tübingen, Tübingen, Germany.""}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Bassler', 'Affiliation': 'University Hospital Zurich, Department of Neonatology, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Rüdiger', 'Affiliation': 'Clinic for Pediatrics, Department for Neonatology and Pediatric Intensive Care Medicine, Medical Faculty, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Ulrich H', 'Initials': 'UH', 'LastName': 'Thome', 'Affiliation': ""Children's Hospital, Division of Neonatology, Department of Women and Children's Health, University of Leipzig, Leipzig, Germany.""}, {'ForeName': 'Rolf F', 'Initials': 'RF', 'LastName': 'Maier', 'Affiliation': ""Children's Hospital, University Hospital, Philipps University Marburg, Marburg, Germany.""}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Krägeloh-Mann', 'Affiliation': ""Department of Paediatric Neurology and Developmental Medicine, University Children's Hospital Tübingen, Tübingen, Germany.""}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Kron', 'Affiliation': 'Institute for Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Essers', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bührer', 'Affiliation': 'Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Rellensmann', 'Affiliation': 'Pediatrics, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Rossi', 'Affiliation': 'Vivantes Klinikum Neukölln, Berlin, Germany.'}, {'ForeName': 'Hans-Jörg', 'Initials': 'HJ', 'LastName': 'Bittrich', 'Affiliation': 'Helios Klinikum Erfurt, Erfurt, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Roll', 'Affiliation': 'Vestische Kinder-und Jugendklinik Datteln, Universität Witten/Herdecke, Datteln, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Höhn', 'Affiliation': 'Neonatology and Pediatric Intensive Care, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Ehrhardt', 'Affiliation': 'Department of General Pediatrics and Neonatology, Justus-Liebig-University Giessen, Giessen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Avenarius', 'Affiliation': 'Pediatrics, University Hospital Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'Hans Thorsten', 'Initials': 'HT', 'LastName': 'Körner', 'Affiliation': 'Neonatology, Klinikum Links der Weser, Bremen, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'Department of Paediatrics I, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Horst', 'Initials': 'H', 'LastName': 'Buxmann', 'Affiliation': 'University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Vochem', 'Affiliation': 'Olgahospital, Klinikum Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Christian F', 'Initials': 'CF', 'LastName': 'Poets', 'Affiliation': ""Neonatology, University Children's Hospital Tübingen, Tübingen, Germany.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.10690']
1915,32780139,"Effect of High Add Power, Medium Add Power, or Single-Vision Contact Lenses on Myopia Progression in Children: The BLINK Randomized Clinical Trial.","Importance


Slowing myopia progression could decrease the risk of sight-threatening complications.
Objective


To determine whether soft multifocal contact lenses slow myopia progression in children, and whether high add power (+2.50 D) slows myopia progression more than medium (+1.50 D) add power lenses.
Design, Setting, and Participants


A double-masked randomized clinical trial that took place at 2 optometry schools located in Columbus, Ohio, and Houston, Texas. A total of 294 consecutive eligible children aged 7 to 11 years with -0.75 D to -5.00 D of spherical component myopia and less than 1.00 D astigmatism were enrolled between September 22, 2014, and June 20, 2016. Follow-up was completed June 24, 2019.
Interventions


Participants were randomly assigned to wear high add power (n = 98), medium add power (n = 98), or single-vision (n = 98) contact lenses.
Main Outcomes and Measures


The primary outcome was the 3-year change in cycloplegic spherical equivalent autorefraction, as measured by the mean of 10 autorefraction readings. There were 11 secondary end points, 4 of which were analyzed for this study, including 3-year eye growth.
Results


Among 294 randomized participants, 292 (99%) were included in the analyses (mean [SD] age, 10.3 [1.2] years; 177 [60.2%] were female; mean [SD] spherical equivalent refractive error, -2.39 [1.00] D). Adjusted 3-year myopia progression was -0.60 D for high add power, -0.89 D for medium add power, and -1.05 D for single-vision contact lenses. The difference in progression was 0.46 D (95% CI, 0.29-0.63) for high add power vs single vision, 0.30 D (95% CI, 0.13-0.47) for high add vs medium add power, and 0.16 D (95% CI, -0.01 to 0.33) for medium add power vs single vision. Of the 4 secondary end points, there were no statistically significant differences between the groups for 3 of the end points. Adjusted mean eye growth was 0.42 mm for high add power, 0.58 mm for medium add power, and 0.66 mm for single vision. The difference in eye growth was -0.23 mm (95% CI, -0.30 to -0.17) for high add power vs single vision, -0.16 mm (95% CI, -0.23 to -0.09) for high add vs medium add power, and -0.07 mm (95% CI, -0.14 to -0.01) for medium add power vs single vision.
Conclusions and Relevance


Among children with myopia, treatment with high add power multifocal contact lenses significantly reduced the rate of myopia progression over 3 years compared with medium add power multifocal and single-vision contact lenses. However, further research is needed to understand the clinical importance of the observed differences.
Trial Registration


ClinicalTrials.gov Identifier: NCT02255474.",2020,"Adjusted 3-year myopia progression was -0.60 D for high add power, -0.89 D for medium add power, and -1.05 D for single-vision contact lenses.","['294 consecutive eligible children aged 7 to 11 years with -0.75 D to -5.00 D of spherical component myopia and less than 1.00 D astigmatism were enrolled between September 22, 2014, and June 20, 2016', 'Children', 'children with myopia', '294 randomized participants, 292 (99%) were included in the analyses (mean\u2009[SD] age, 10.3\u2009[1.2] years; 177 [60.2%] were female; mean [SD] spherical equivalent refractive error, -2.39']","['single-vision (n\u2009=\u200998) contact lenses', 'High Add Power, Medium Add Power, or Single-Vision Contact Lenses']","['rate of myopia progression', 'progression', '3-year eye growth', 'Adjusted 3-year myopia progression', '3-year change in cycloplegic spherical equivalent autorefraction, as measured by the mean of 10 autorefraction readings', 'eye growth']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1275644', 'cui_str': 'Reading addition power'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0010586', 'cui_str': 'Cycloplegic preparation'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",294.0,0.396685,"Adjusted 3-year myopia progression was -0.60 D for high add power, -0.89 D for medium add power, and -1.05 D for single-vision contact lenses.","[{'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Walline', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Maria K', 'Initials': 'MK', 'LastName': 'Walker', 'Affiliation': 'University of Houston College of Optometry; Houston, Texas.'}, {'ForeName': 'Donald O', 'Initials': 'DO', 'LastName': 'Mutti', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Jones-Jordan', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Loraine T', 'Initials': 'LT', 'LastName': 'Sinnott', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Amber Gaume', 'Initials': 'AG', 'LastName': 'Giannoni', 'Affiliation': 'University of Houston College of Optometry; Houston, Texas.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Bickle', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Krystal L', 'Initials': 'KL', 'LastName': 'Schulle', 'Affiliation': 'University of Houston College of Optometry; Houston, Texas.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Nixon', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'Gilbert E', 'Initials': 'GE', 'LastName': 'Pierce', 'Affiliation': 'The Ohio State University College of Optometry; Columbus.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Berntsen', 'Affiliation': 'University of Houston College of Optometry; Houston, Texas.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.10834']
1916,32776489,Outcomes in children with hemophilia A with inhibitors: Results from a noninterventional study.,"BACKGROUND


Data regarding management of pediatric persons with hemophilia A (PwHA) with factor VIII (FVIII) inhibitors are limited. This prospective noninterventional study (NCT02476942) evaluated annualized bleeding rates (ABRs), safety, and health-related quality of life (HRQoL) in pediatric PwHA with FVIII inhibitors.
PROCEDURE


PwHA aged <12 years with current FVIII inhibitors and high-titer inhibitor history were enrolled. Participants remained on usual treatment; no interventions were applied. Outcomes included ABR, safety, and HRQoL.
RESULTS


Twenty-four PwHA aged 2-11 years (median 7.5) were enrolled and monitored for 8.7-44.1 weeks (median 23.4). In the episodic (n = 10) and prophylactic (n = 14) groups, respectively, 121 of 185 (65.4%) and 101 of 186 (54.3%) bleeds were treated using activated prothrombin complex concentrate (aPCC) and/or recombinant activated FVII (rFVIIa). ABRs (95% confidence interval) were 19.4 (13.2-28.4) and 18.5 (14.2-24.0) for treated bleeds, and 32.7 (20.5-52.2) and 33.1 (22.4-48.9) for all bleeds, respectively. Most prophylactic group participants (92.9%) were prescribed aPCC; 50% adhered to their prescribed treatment regimen. Adherence to prophylactic rFVIIa was not assessed. Serious adverse events included hemarthrosis (12.5%) and mouth hemorrhage (12.5%); the most common nonserious adverse event was viral upper respiratory tract infection (12.5%). HRQoL showed functional impairment at baseline; scores remained stable throughout, with little intergroup variation.
CONCLUSIONS


ABRs remained high in pediatric PwHA with inhibitors receiving standard treatment. This study demonstrates the need for more effective treatments, with reduced treatment burden, to prevent bleeds, increase prophylaxis adherence, and improve patient outcomes.",2020,Serious adverse events included hemarthrosis (12.5%) and mouth hemorrhage (12.5%); the most common nonserious adverse event was viral upper respiratory tract infection (12.5%).,"['PwHA aged <12\xa0years with current FVIII inhibitors and high-titer inhibitor history were enrolled', 'children with hemophilia A with inhibitors', 'pediatric persons with hemophilia A (PwHA) with factor VIII']",['activated prothrombin complex concentrate (aPCC) and/or recombinant activated FVII (rFVIIa'],"['annualized bleeding rates (ABRs), safety, and health-related quality of life (HRQoL', 'ABRs', 'mouth hemorrhage', 'ABR, safety, and HRQoL']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0368953', 'cui_str': 'Factor VIII antibody'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0472802', 'cui_str': 'Hereditary factor VIII deficiency disease with inhibitor'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0015506', 'cui_str': 'Factor VIII'}]","[{'cui': 'C0358606', 'cui_str': 'Coagulation factor II- and coagulation factor IX- and coagulation factor VIIa- and coagulation factor VIII- and coagulation factor X-containing product'}, {'cui': 'C0534191', 'cui_str': 'Eptacog alfa'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0029163', 'cui_str': 'Bleeding from mouth'}]",,0.101006,Serious adverse events included hemarthrosis (12.5%) and mouth hemorrhage (12.5%); the most common nonserious adverse event was viral upper respiratory tract infection (12.5%).,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Oldenburg', 'Affiliation': 'Institute of Experimental Hematology and Transfusion Medicine, Universitätsklinikum Bonn, Bonn, Germany.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Shima', 'Affiliation': 'Department of Pediatrics, Nara Medical University, Nara, Japan.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Kruse-Jarres', 'Affiliation': 'Washington Center for Bleeding Disorders at Bloodworks Northwest, University of Washington, Seattle, Washington.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Santagostino', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Milan, Italy.""}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Mahlangu', 'Affiliation': 'Haemophilia Comprehensive Care Centre, Faculty of Health Sciences, University of the Witwatersrand and NHLS, Johannesburg, South Africa.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Lehle', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Nives', 'Initials': 'N', 'LastName': 'Selak Bienz', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Sammy', 'Initials': 'S', 'LastName': 'Chebon', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Asikanius', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Trask', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Maria Elisa', 'Initials': 'ME', 'LastName': 'Mancuso', 'Affiliation': ""Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Milan, Italy.""}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Jiménez-Yuste', 'Affiliation': 'Hospital Universitario La Paz, Autonoma University, Madrid, Spain.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'von Mackensen', 'Affiliation': 'University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Gallia G', 'Initials': 'GG', 'LastName': 'Levy', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}]",Pediatric blood & cancer,['10.1002/pbc.28474']
1917,32777193,Intravenous methylprednisolone versus intravenous methylprednisolone combined with inhaled budesonide in acute severe pediatric asthma.,"INTRODUCTION


Corticosteroids are important part of acute severe asthma (ASA) management in pediatric intensive care units. Few studies look at the efficacy of inhaled corticosteroids (ICS) in critical care settings. We aimed to investigate the potential beneficial effects of ICS when added to intravenous corticosteroids in pediatric patients with ASA admitted to the pediatric intensive care unit (PICU).
METHODS


This was a randomized controlled trial involving pediatric patients aged 1-21 years admitted to PICU with ASA. Patients were randomized into 2 groups using block randomization. Patients in Group A received intravenous methylprednisolone (2 mg/kg/day) alone and patients in Group B received intravenous methylprednisolone (2 mg/kg/day) plus budesonide nebulization (0.5 mg every 12 h). Main outcomes were duration of continuous albuterol treatment, PICU and hospital length of stay (LOS), and need and duration of respiratory support. Kruskal-Wallis and Chi-square tests were used for statistical analysis, in which a p-value < 0.05 was considered statistically significant.
RESULTS


Duration of continuous albuterol treatment was not different between the 2 groups median/(QR), 30/(18-51) vs. 25/(14-49). ( p  = 0.38) PICU and hospital LOS between the 2 groups was similar, median/(QR), 44/(30-64) vs. 46/(30-62), ( p  = 0.75) and 78/(65-95) vs.72/(58-92), ( p  = 0.19). Number of patients requiring respiratory support was 22(58%) in Group A and 25(64%) in Group B ( p  = 0.19).
CONCLUSIONS


In critically ill children with ASA, intravenous methylprednisolone combined with inhaled budesonide did not shorten the duration of continuous albuterol inhalation treatment, the PICU and hospital LOS, and the need for respiratory support.",2020,"was not different between the 2 groups median/(QR), 30/(18-51) vs. 25/(14-49).","['critically ill children with ASA, intravenous', 'pediatric patients with ASA admitted to the pediatric intensive care unit (PICU) Methods', 'pediatric patients aged 1-21 years admitted to PICU with ASA', 'Acute Severe Pediatric Asthma']","['Intravenous Methylprednisolone', 'methylprednisolone combined with inhaled budesonide', 'ICS', 'budesonide nebulization', 'Corticosteroids', 'intravenous methylprednisolone', 'inhaled corticosteroids (ICS', 'Methylprednisolone Combined with Inhaled Budesonide', 'intravenous corticosteroids']","['duration of continuous albuterol treatment, PICU and hospital length of stay (LOS), and need and duration of respiratory support', 'hospital LOS', 'duration of continuous albuterol inhalation treatment, the PICU and hospital LOS', 'Kruskal-Wallis and Chi-square tests']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021710', 'cui_str': 'Pediatric intensive care unit'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1046445', 'cui_str': 'Picus'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0008041', 'cui_str': 'Chi-Square Test'}]",,0.151915,"was not different between the 2 groups median/(QR), 30/(18-51) vs. 25/(14-49).","[{'ForeName': 'Prabhavathi', 'Initials': 'P', 'LastName': 'Gummalla', 'Affiliation': 'Department of Pediatrics, SUNY Downstate Health Sciences University, Brooklyn, NY, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Weaver', 'Affiliation': 'Department of Pediatrics, SUNY Downstate Health Sciences University, Brooklyn, NY, USA.'}, {'ForeName': 'Youssef', 'Initials': 'Y', 'LastName': 'Ahmed', 'Affiliation': 'Department of Pediatrics, SUNY Downstate Health Sciences University, Brooklyn, NY, USA.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Shah', 'Affiliation': 'Department of Pediatrics, Kings County Hospital Center, Brooklyn, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Keenaghan', 'Affiliation': 'Department of Pediatrics, Kings County Hospital Center, Brooklyn, NY, USA.'}, {'ForeName': 'Sule', 'Initials': 'S', 'LastName': 'Doymaz', 'Affiliation': 'Department of Pediatrics, SUNY Downstate Health Sciences University, Brooklyn, NY, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1808988']
1918,32777247,Does Repositioning of Temporomandibular Joint Disc With Bone Anchors Provide Better Clinical Outcomes Than Conventional Disc Plication Procedures for Anterior Disc Displacements Without Reduction in Patients Refractory to Nonsurgical Treatments?,"PURPOSE


Although open temporomandibular joint arthroplasty with discopexy is a common treatment for patients with anterior disc displacements without reduction (ADDWo) unresponsive to medical management, there are no studies comparing disc repositioning with bone anchors and conventional discopexy procedure. The purpose of the study was to compare the efficacy between disc repositioning with bone anchors and the conventional discopexy procedure for ADDWo of temporomandibular joint refractory to medical management.
PATIENTS AND METHODS


A randomized controlled trial was conducted in patients with ADDWo. The primary objective was to compare the improvement in mouth opening (primary outcome variable) between the 2 treatment (primary predictor variable) groups-disc repositioning with bone anchors versus conventional disc plication. Secondary outcome variables were pain measured by visual analog scale, lateral excursions, and position of the disc evaluated by magnetic resonance imaging (MRI). Other variables of interest were age, gender, and duration of symptoms. The parameters were evaluated at preoperative, postoperative day 1, and 1-, 6-, and 12-month postoperative period. Categorical variables were compared with χ 2  test and continuous variables with analysis of variance and adjusted for multiple comparisons with Bonferroni test.
RESULTS


The study sample comprised 14 patients (7 in each group) with MRI-proven ADDWo. Statistically significant differences were found in the improvement of mouth opening between the 2 groups, showing better improvement with bone anchors (14.42 ± 5.96 vs 7.57 ± 7.25 mm; P < .05). The reduction in visual analog scale also showed statistically significant difference with better pain reduction achieved with bone anchor (4.57 ± 1.61 vs 3.28 ± 0.75; P < .05). There was no statistically significant difference in lateral excursions and postoperative position of the disc evaluated by MRI between the groups at the 12-month follow-up period.
CONCLUSIONS


Disc repositioning with bone anchors provides better clinical outcomes in terms of maximal mouth opening and pain scores compared with conventional disc plication.",2020,"Statistically significant differences were found in the improvement of mouth opening between the 2 groups, showing better improvement with bone anchors (14.42 ± 5.96 vs 7.57 ± 7.25 mm; P < .05).","['14 patients (7 in each group) with MRI-proven ADDWo', 'patients with anterior disc displacements without reduction (ADDWo) unresponsive to medical management', 'patients with ADDWo']","['discopexy', 'Conventional Disc Plication Procedures', 'disc repositioning with bone anchors and the conventional discopexy procedure', 'Disc repositioning with bone anchors']","['pain scores', 'Anterior Disc Displacements', 'improvement of mouth opening', 'pain reduction', 'Temporomandibular Joint Disc', 'pain measured by visual analog scale, lateral excursions, and position of the disc evaluated by magnetic resonance imaging (MRI', 'improvement in mouth opening', 'lateral excursions and postoperative position of the disc evaluated by MRI', 'visual analog scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C1720978', 'cui_str': 'Bone Anchors'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376491', 'cui_str': 'Structure of articular disc of temporomandibular joint'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",14.0,0.0853924,"Statistically significant differences were found in the improvement of mouth opening between the 2 groups, showing better improvement with bone anchors (14.42 ± 5.96 vs 7.57 ± 7.25 mm; P < .05).","[{'ForeName': 'Jithin Sasikumar', 'Initials': 'JS', 'LastName': 'Puthukkudiyil', 'Affiliation': 'Senior Resident, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.'}, {'ForeName': 'Ongkila', 'Initials': 'O', 'LastName': 'Bhutia', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India. Electronic address: dr_ongkila@rediffmail.com.'}, {'ForeName': 'Ajoy', 'Initials': 'A', 'LastName': 'Roychoudhury', 'Affiliation': 'Professor and Head, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.'}, {'ForeName': 'Krushna', 'Initials': 'K', 'LastName': 'Bhatt', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Yadav', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.'}, {'ForeName': 'Ashu Seith', 'Initials': 'AS', 'LastName': 'Bhalla', 'Affiliation': 'Professor, Department of Radio Diagnosis, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.07.013']
1919,32777381,Trial study design to test a bilingual digital health tool for alcohol use disorders among Latino emergency department patients.,"We describe an emergency department (ED)-based, Latino patient focused, unblinded, randomized controlled trial to empirically test if automated bilingual computerized alcohol screening and brief intervention (AB-CASI), a digital health tool, is superior to standard care (SC) on measures of alcohol consumption, alcohol-related negative behaviors and consequences, and 30-day treatment engagement. The trial design addresses the full spectrum of unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD). In an effort to surmount known ED-based alcohol screening, brief intervention, and referral to treatment process barriers, while addressing racial/ethnic alcohol-related health disparities among Latino groups, this trial will purposively use a digital health tool and seek enrollment of English and/or Spanish speaking self-identified adult Latino ED patients. Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish). The primary outcome will be the number of binge drinking days assessed using the 28-day timeline followback method at 12 months post-randomization. Secondary outcomes will include mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school. A sample size of 820 is necessary to provide 80% power to detect a 1.14 difference between AB-CASI and SC in the primary outcome. Showing efficacy of this promising bilingual ED-based brief intervention tool in Latino patients has the potential to widely and efficiently expand prevention efforts and facilitate meaningful contact with specialized treatment services.",2020,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","['Latino patients', 'English and/or Spanish speaking self-identified adult Latino ED patients', 'Latino emergency department patients', 'unhealthy drinking from high-risk drinking to severe alcohol use disorder (AUD']","['automated bilingual computerized alcohol screening and brief intervention (AB-CASI', 'bilingual digital health tool']","['mean number of drinks/week and number of episodes of driving impaired, riding with an impaired driver, injuries, arrests, and tardiness and days absent from work/school', 'number of binge drinking days assessed using the 28-day timeline followback method']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",,0.0627793,"Participants will be randomized (1:1) to AB-CASI or SC, stratified by AUD severity and preferred language (English vs. Spanish).","[{'ForeName': 'Federico E', 'Initials': 'FE', 'LastName': 'Vaca', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: federico.vaca@yale.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: james.dziura@yale.edu.'}, {'ForeName': 'Fuad', 'Initials': 'F', 'LastName': 'Abujarad', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: fuad.abujarad@yale.edu.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Pantalon', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: michael.pantalon@yale.edu.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Hsiao', 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America; Yale School of Medicine, Department of Pediatrics, Section of Emergency Medicine, 100 York St, Suite 1F, New Haven, CT 06511, United States of America. Electronic address: allen.hsiao@yale.edu.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'University of Texas at El Paso, Latino Alcohol and Health Disparities Research Center (LAHDR), Psychology Building, Rooms 102 and 104, El Paso, TX 79968, United States of America. Electronic address: cfield@utep.edu.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': ""D'Onofrio"", 'Affiliation': 'Yale School of Medicine, Department of Emergency Medicine, 464 Congress Avenue, Suite 260, New Haven, CT 06519, United States of America. Electronic address: gail.donofrio@yale.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106104']
1920,32777923,Effects of Process-Based Cognitive Training on Memory in the Healthy Elderly and Patients with Mild Cognitive Impairment: A Randomized Controlled Trial.,"OBJECTIVE


This study investigated the effects of process-based cognitive training that targets working memory and cognitive control on memory improvement in healthy elderly individuals and patients with mild cognitive impairment (MCI).
METHODS


Forty healthy subjects and 40 patients with MCI were randomly assigned to either the intervention or control group. The intervention group received 12 sessions of designated cognitive training. The control group did not receive cognitive training. A memory test was administered pre-intervention, post-intervention, and 4 weeks after the intervention. Additional comprehensive neuropsychological tests were also administered including a depression scale questionnaire.
RESULTS


Performance in attention and working memory, which are directly related to the training domains, and global cognitive function were improved in the intervention group after training. In memory tests, interference by irrelevant stimuli was reduced and recognition memory was improved after the intervention. Furthermore, cognitive training ameliorated depressive symptoms. These training effects were not dependent on MCI status.
CONCLUSION


Process-based cognitive training that targets working memory and cognitive control effectively improves memory processes including retrograde interference and recognition, as well as depressive symptoms associated with aging in healthy elderly individuals and patients with MCI.",2020,"RESULTS


Performance in attention and working memory, which are directly related to the training domains, and global cognitive function were improved in the intervention group after training.","['Forty healthy subjects and 40 patients with MCI', 'Healthy Elderly and Patients with Mild Cognitive Impairment', 'healthy elderly individuals and patients with MCI', 'healthy elderly individuals and patients with mild cognitive impairment (MCI']","['cognitive training', 'Process-based cognitive training', '12 sessions of designated cognitive training', 'process-based cognitive training that targets working memory and cognitive control', 'Process-Based Cognitive Training']","['global cognitive function', 'depression scale questionnaire', 'recognition memory', 'depressive symptoms']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",40.0,0.0209777,"RESULTS


Performance in attention and working memory, which are directly related to the training domains, and global cognitive function were improved in the intervention group after training.","[{'ForeName': 'Minyoung', 'Initials': 'M', 'LastName': 'Shin', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ahee', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'A Young', 'Initials': 'AY', 'LastName': 'Cho', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Minam', 'Initials': 'M', 'LastName': 'Son', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yun-Hee', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Center for Prevention and Rehabilitation, Heart Vascular and Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",Psychiatry investigation,['10.30773/pi.2019.0225']
1921,32778146,Effect of dexmedetomidine on inflammation in patients with sepsis requiring mechanical ventilation: a sub-analysis of a multicenter randomized clinical trial.,"BACKGROUND


Administration of dexmedetomidine has been reported to improve inflammatory response in animals. We explored the effects of administering dexmedetomidine on the levels of C-reactive protein (CRP) and procalcitonin, and thus on inflammation, in patients with sepsis enrolled in a randomized clinical trial.
METHODS


The DESIRE trial was a multicenter randomized clinical trial in which adult patients with sepsis were sedated with (DEX group) or without (non-DEX group) dexmedetomidine while on mechanical ventilators. As a prespecified sub-analysis, we compared CRP and procalcitonin levels during the first 14 days of treatment between the two groups. The 14-day mortality rate, albumin level, and the number of patients with disseminated intravascular coagulation (DIC) were also assessed. We used generalized linear models to estimate the differences in these outcomes between groups. We also used the Kaplan-Meier method to estimate the 14-day mortality rate and the log-rank test to assess between-group differences.
RESULTS


Our study comprised 201 patients: 100 in the DEX group and 101 in the non-DEX group. CRP and procalcitonin levels were lower in the DEX vs. non-DEX group during the 14-day treatment period [CRP-range, 5.6-20.3 vs. 8.3-21.1 mg/dL (P = 0.03); procalcitonin-range, 1.2-37.4 vs. 1.7-52.9 ng/mL (P = 0.04)]. Albumin levels were higher in the DEX group (range, 2.3-2.6 g/dL) than in the non-DEX group (range, 2.1-2.7 g/dL; P = 0.01). The percentage of patients with DIC did not significantly differ between the groups (range, 21-59% and 17-56% for the DEX and non-DEX groups, respectively; P = 0.49). The 14-day mortality rates in the DEX and non-DEX groups were 13 and 21%, respectively (P = 0.16).
CONCLUSION


Sedation using dexmedetomidine reduced inflammation in patients with sepsis requiring mechanical ventilation.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01760967 . Registered on 4 January 2013.",2020,"CRP and procalcitonin levels were lower in the DEX vs. non-DEX group during the 14-day treatment period [CRP-range, 5.6-20.3 vs. 8.3-21.1 mg/dL (P = 0.03); procalcitonin-range, 1.2-37.4 vs. 1.7-52.9 ","['patients with sepsis enrolled in a randomized clinical trial', '201 patients: 100 in the DEX group and 101 in the non-DEX group', 'adult patients with sepsis were', 'patients with sepsis requiring mechanical ventilation']","['DEX vs. non-DEX', 'DEX', 'DEX and non-DEX', 'dexmedetomidine', 'sedated with (DEX group) or without (non-DEX group) dexmedetomidine']","['Albumin levels', 'percentage of patients with DIC', '14-day mortality rate, albumin level, and the number of patients with disseminated intravascular coagulation (DIC', 'CRP and procalcitonin levels', '14-day mortality rate', '14-day mortality rates', 'inflammatory response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0201838', 'cui_str': 'Albumin measurement'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012739', 'cui_str': 'Disseminated intravascular coagulation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}]",,0.136848,"CRP and procalcitonin levels were lower in the DEX vs. non-DEX group during the 14-day treatment period [CRP-range, 5.6-20.3 vs. 8.3-21.1 mg/dL (P = 0.03); procalcitonin-range, 1.2-37.4 vs. 1.7-52.9 ","[{'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Ohta', 'Affiliation': 'Education and Training Center for Students and Professionals in Healthcare, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Kyohei', 'Initials': 'K', 'LastName': 'Miyamoto', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Kawazoe', 'Affiliation': 'Division of Emergency and Critical Care Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Yamamura', 'Affiliation': 'Osaka Prefectural Nakakawachi Emergency and Critical Care Center, Higashiosaka, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Morimoto', 'Affiliation': 'Department of Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan. morimoto@kuhp.kyoto-u.ac.jp.'}]","Critical care (London, England)",['10.1186/s13054-020-03207-8']
1922,32778150,Postprandial effects of a meal low in sulfur amino acids and high in polyunsaturated fatty acids compared to a meal high in sulfur amino acids and saturated fatty acids on stearoyl CoA-desaturase indices and plasma sulfur amino acids: a pilot study.,"OBJECTIVE


The sulfur amino acid (SAA) cysteine is positively related, whereas polyunsaturated fatty acids (PUFAs) are inversely related to activity of the lipogenic enzyme stearoyl-CoA desaturase (SCD). High SCD activity promotes obesity in animals, and plasma activity indices positively associates with fat mass in humans. SCD may thus be a target for dietary intervention with SAA restriction and PUFA enrichment with unknown potential benefits for body composition. We randomized ten healthy individuals to a meal restricted in SAAs and enriched with PUFAs (Cys/Met low  + PUFA) (n = 5) or a meal enriched in SAA and saturated fatty acids (Cys/Met high  + SFA) (n = 5). We measured plasma SCD activity indices (SCD16 and SCD18) and SAAs response hourly from baseline and up to 4 h postprandial.
RESULTS


SCD16 was unchanged whereas SCD18 tended to increase in the Cys/Met low  + PUFA compared to the Cys/Met high  + SFA group (p time*group interaction  = 0.08). Plasma concentrations of total cysteine fractions including free and reduced cysteine decreased in the Cys/Met low  + PUFA compared to the Cys/Met high  + SFA group (both p time*group interaction  < 0.001). In conclusion, a meal low in SAA but high in PUFAs reduced plasma cysteine fractions but not SCD activity indices. This pilot study can be useful for the design and diet composition of future dietary interventions that targets SCD and SAA. Trial registration ClinicalTrials.gov: NCT02647970, registration date: 6 January 2016.",2020,Plasma concentrations of total cysteine fractions including free and reduced cysteine decreased in the Cys/Met low  + PUFA compared to the Cys/Met high  + SFA group (both p time*group interaction  < 0.001).,['healthy individuals to a meal restricted in SAAs and enriched with PUFAs (Cys/Met low \u2009+\u2009PUFA) (n\u2009=\u20095) or a'],"['SCD', 'sulfur amino acid (SAA) cysteine', 'meal enriched in SAA and saturated fatty acids (Cys/Met high \u2009+\u2009SFA']","['Postprandial effects', 'Plasma concentrations of total cysteine fractions including free and reduced cysteine', 'SCD18', 'plasma SCD activity indices (SCD16 and SCD18) and SAAs response hourly']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}]","[{'cui': 'C0038233', 'cui_str': 'Acyl-CoA desaturase'}, {'cui': 'C0002527', 'cui_str': 'Sulfur-bearing amino acid'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0038233', 'cui_str': 'Acyl-CoA desaturase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}]",10.0,0.0315221,Plasma concentrations of total cysteine fractions including free and reduced cysteine decreased in the Cys/Met low  + PUFA compared to the Cys/Met high  + SFA group (both p time*group interaction  < 0.001).,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Olsen', 'Affiliation': 'Department of Nutrition, Institute of Medical Biosciences, University of Oslo, 0372, Oslo, Norway. thomas.olsen@medisin.uio.no.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Turner', 'Affiliation': 'Department of Pharmacology, University of Oxford, Oxford, OX1 3QT, UK.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Øvrebø', 'Affiliation': 'Department of Nutrition, Institute of Medical Biosciences, University of Oslo, 0372, Oslo, Norway.'}, {'ForeName': 'Nasser E', 'Initials': 'NE', 'LastName': 'Bastani', 'Affiliation': 'Department of Nutrition, Institute of Medical Biosciences, University of Oslo, 0372, Oslo, Norway.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Refsum', 'Affiliation': 'Department of Nutrition, Institute of Medical Biosciences, University of Oslo, 0372, Oslo, Norway.'}, {'ForeName': 'Kathrine J', 'Initials': 'KJ', 'LastName': 'Vinknes', 'Affiliation': 'Department of Nutrition, Institute of Medical Biosciences, University of Oslo, 0372, Oslo, Norway.'}]",BMC research notes,['10.1186/s13104-020-05222-y']
1923,32773484,The effect of universal testing and treatment on HIV stigma in 21 communities in Zambia and South Africa: results from a cluster randomised trial.,"OBJECTIVES


To assess the impact of a combination HIV prevention intervention including universal testing and treatment (UTT) on HIV stigma among people living with HIV, and among community members and health workers not living with HIV.
DESIGN


This HIV stigma study was nested in the HPTN 071 (PopART) trial, a three-arm cluster randomised trial conducted between 2013-2018 in 21 urban/peri-urban communities (12 in Zambia and 9 in South Africa).
METHODS


Using an adjusted two-stage cluster-level analysis, controlling for baseline imbalances, we compared multiple domains of stigma between the trial arms at 36 months. Different domains of stigma were measured among three cohorts recruited across all study communities: 4,178 randomly sampled adults aged 18-44 who were living with HIV, and 3,487 randomly sampled adults and 1,224 health workers who did not self-report living with HIV.
RESULTS


Prevalence of any stigma reported by people living with HIV at 36 months was 20.2% in arm A, 26.1% in arm B, and 19.1% in arm C (adjusted prevalence ratio, A vs C 1.01 95% CI 0.49-2.08, B vs C 1.34 95% CI 0.65-2.75). There were no significant differences between arms in any other measures of stigma across all three cohorts. All measures of stigma reduced over time (0.2% to 4.1% reduction between rounds) with most reductions statistically significant.
CONCLUSIONS


We found little evidence that UTT either increased or decreased HIV stigma measured among people living with HIV, or among community members or health workers not living with HIV. Stigma reduced over time, but slowly.ClinicalTrials.gov number, NCT01900977.",2020,"We found little evidence that UTT either increased or decreased HIV stigma measured among people living with HIV, or among community members or health workers not living with HIV.","['three cohorts recruited across all study communities: 4,178 randomly sampled adults aged 18-44 who were living with HIV, and 3,487 randomly sampled adults and 1,224 health workers who did not self-report living with HIV', '21 communities in Zambia and South Africa', 'This HIV stigma study was nested in the HPTN 071 (PopART) trial, a three-arm cluster randomised trial conducted between 2013-2018 in 21\u200aurban/peri-urban communities (12 in Zambia and 9 in South Africa', 'people living with HIV, and among community members and health workers not living with HIV']","['universal testing and treatment', 'combination HIV prevention intervention including universal testing and treatment (UTT']","['stigma', 'HIV stigma']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0680022', 'cui_str': 'Member of'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]",4178.0,0.520195,"We found little evidence that UTT either increased or decreased HIV stigma measured among people living with HIV, or among community members or health workers not living with HIV.","[{'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Stangl', 'Affiliation': 'International Center for Research on Women, Washington, D.C., USA.'}, {'ForeName': 'Triantafyllos', 'Initials': 'T', 'LastName': 'Pliakas', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, U.K.'}, {'ForeName': 'Tila', 'Initials': 'T', 'LastName': 'Mainga', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Steinhaus', 'Affiliation': 'International Center for Research on Women, Washington, D.C., USA.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Mubekapi-Musadaidzwa', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Lario', 'Initials': 'L', 'LastName': 'Viljoen', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Dunbar', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Ab', 'Initials': 'A', 'LastName': 'Schaap', 'Affiliation': 'Zambart, School of Public Health, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Floyd', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, U.K.'}, {'ForeName': 'Nomtha', 'Initials': 'N', 'LastName': 'Mandla', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Bond', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, U.K.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'Hoddinott', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'Department of Infectious Disease, Imperial College, London, U.K.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, U.K.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, U.K.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bock', 'Affiliation': 'Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'SCHARP, Seattle, Washington, US.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hargreaves', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, U.K.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002658']
1924,32773524,Comparison of Clinical Options: High-Fidelity Manikin-Based and Virtual Simulation.,"BACKGROUND


Minimal evidence compares nursing student outcomes when replacing clinical hours with manikin-based high-fidelity patient simulation (HFPS) or virtual simulation.
PURPOSE


The study aims were to compare differences in outcomes: (1) between 2 intervention groups (HFPS or virtual simulation) when replacing 25% of pediatric/obstetrics clinical hours and (2) pass/fail for clinical practice between the intervention groups and a face-to-face clinical group (control).
METHODS


A quasi-experimental study was conducted to determine differences in knowledge between intervention groups participating in 6 pediatric/obstetrics simulation scenarios.
RESULTS


No differences in composite knowledge were found between simulation groups (P = .319). There also was no difference in clinical practice pass/fail among the groups.
CONCLUSIONS


HFPS and virtual simulation were equally effective in achieving learning goals.",2020,No differences in composite knowledge were found between simulation groups (P = .319).,['intervention groups participating in 6 pediatric/obstetrics simulation scenarios'],"['2 intervention groups (HFPS or virtual simulation) when replacing 25% of pediatric/obstetrics clinical hours and (2) pass/fail for clinical practice between the intervention groups and a face-to-face clinical group (control', 'Fidelity Manikin-Based and Virtual Simulation']",['composite knowledge'],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0085137', 'cui_str': 'Patient Simulation'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0226758,No differences in composite knowledge were found between simulation groups (P = .319).,"[{'ForeName': 'Desiree A', 'Initials': 'DA', 'LastName': 'Díaz', 'Affiliation': 'Author Affiliations: Assistant Professor (Dr Díaz), Associate Professor (Drs Anderson and Quelly), Instructor (Ms Hill), and Research Assistant (Ms Lynn), Department of Nursing Practice, University of Central Florida, Orlando; and PhD Candidate (Ms Clark), School of Nursing, Community Health Systems, University of California, San Francisco.'}, {'ForeName': 'Mindi', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Peggy P', 'Initials': 'PP', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Quelly', 'Affiliation': ''}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Clark', 'Affiliation': ''}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Lynn', 'Affiliation': ''}]",Nurse educator,['10.1097/NNE.0000000000000906']
1925,32781112,Maintenance of muscle strength following a one-year resistance training program in older adults.,"BACKGROUND


Muscle mass, strength and function declines with advancing age. Strength training (ST) improves these parameters in older adults, but the gains often disappear after completion of a short-term intervention. The purpose of the present study was to investigate muscle mass, -strength and -function one year after the completion of a successful long-term (12 months) supervised ST program in older adults.
METHOD


Men and women (n = 419, age: 62-70 years) completed one year of supervised heavy resistance training (HRT, n = 143) or moderate intensity resistance training (MIT, n = 144) and were compared to a non-exercising control group (CON, n = 132). At 1-year follow-up, 398 participants returned for measurements of muscle power, -strength and -mass, physical function, body composition, hippocampus volume and physical/mental well-being. The results were compared to pre-training (baseline) and post-training (1-year) values. Further, the participants from the two previous training groups (HRT + MIT, n = 265) were divided into 1) those who on their own continued the ST program (>9 months) the year after completion of the supervised ST program (CONTIN, n = 65) and 2) those who stopped during the follow-up year (<9 months) (STOP, n = 200).
RESULTS


Out of all the improvements obtained after the 1-year training intervention, only knee extensor muscle strength in HRT was preserved at 1-year follow-up (p < 0.0001), where muscle strength was 7% higher than baseline. Additionally, the decrease in muscle strength over the second year was lower in CONTIN than in STOP with decreases of 1% and 6%, respectively (p < 0.05). Only in CONTIN was the muscle strength still higher at 1-year follow-up compared with baseline with a 14% increase (p < 0.0001). The heavy strength training induced increase in whole-body lean mass was erased at 1-year follow-up. However, there was a tendency for maintenance of the cross-sectional area of m. vastus lateralis from baseline to 1-year follow-up in HRT compared with CON (p = 0.06). Waist circumference decreased further over the second year in CONTIN, whereas it increased in STOP (p < 0.05).
CONCLUSION


Even though long-term strength training effectively improved muscle function and other health parameters in older adults, only knee extensor muscle strength was preserved one year after completion of heavy (but not moderate intensity) resistance training. Continuation of strength training resulted in better maintenance of muscle strength and health, which indicates that it is required to continue with physical activity to benefit from the long-term effects of strength training upon muscle function and health in older men and women.",2020,"Waist circumference decreased further over the second year in CONTIN, whereas it increased in STOP (p < 0.05).
","['older adults', 'Men and women (n\u202f=\u202f419, age: 62-70\u202fyears) completed one year of', 'older men and women']","['Strength training (ST', 'training intervention', 'supervised heavy resistance training (HRT, n\u202f=\u202f143) or moderate intensity resistance training (MIT, n\u202f=\u202f144) and were compared to a non-exercising control', 'heavy strength training', 'strength training', 'successful long-term (12\u202fmonths) supervised ST program']","['knee extensor muscle strength', 'knee extensor muscle strength in HRT', 'Waist circumference', 'muscle function and other health parameters', 'muscle strength still higher', 'muscle power, -strength and -mass, physical function, body composition, hippocampus volume and physical/mental well-being', 'muscle strength', 'whole-body lean mass']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0282402', 'cui_str': 'Hormone replacement therapy'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}]",265.0,0.0132112,"Waist circumference decreased further over the second year in CONTIN, whereas it increased in STOP (p < 0.05).
","[{'ForeName': 'Anne Theil', 'Initials': 'AT', 'LastName': 'Gylling', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Center for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark. Electronic address: anne.theil.gylling@regionh.dk.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Bloch-Ibenfeldt', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Center for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Christian Skou', 'Initials': 'CS', 'LastName': 'Eriksen', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Center for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Andreas Kraag', 'Initials': 'AK', 'LastName': 'Ziegler', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Center for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Cathrine Lawaetz', 'Initials': 'CL', 'LastName': 'Wimmelmann', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Baekgaard', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Center for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}, {'ForeName': 'Carl-Johan', 'Initials': 'CJ', 'LastName': 'Boraxbekk', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Center for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen NV, Denmark; Danish Research Center for Magnetic Resonance, Center for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, 2650 Hvidovre, Denmark; Department of Radiation Sciences, Umeå University, S-901 87 Umeå, Sweden.'}, {'ForeName': 'Hartwig Roman', 'Initials': 'HR', 'LastName': 'Siebner', 'Affiliation': 'Danish Research Center for Magnetic Resonance, Center for Functional and Diagnostic Imaging and Research, Copenhagen University Hvidovre Hospital, Kettegaard Allé 30, 2650 Hvidovre, Denmark; Department of Neurology, Bispebjerg and Frederiksberg Hospital, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark.'}, {'ForeName': 'Erik Lykke', 'Initials': 'EL', 'LastName': 'Mortensen', 'Affiliation': 'Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark; Department of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Øster Farimagsgade 5A, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kjaer', 'Affiliation': 'Institute of Sports Medicine Copenhagen, Department of Orthopaedic Surgery M81 and Center for Translational Research, Bispebjerg and Frederiksberg Hospital, Nielsine Nielsensvej 11, 2400 Copenhagen NV, Denmark; Center for Healthy Aging, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200 Copenhagen N, Denmark.'}]",Experimental gerontology,['10.1016/j.exger.2020.111049']
1926,32786068,Exercise-induced elevations in cerebral blood velocity are greater in running compared to cycling at higher intensities.,"The optimal exercise intensity and modality for maximizing cerebral blood flow (CBF) and hence potential exposure to positive, hemodynamically derived cerebral adaptations is yet to be fully determined. This study compared CBF velocity responses between running and cycling across a range of exercise intensities. Twenty-six participants (12 females; age: 26 ± 8 years) completed four exercise sessions; two mode-specific maximal oxygen consumption (VO 2max  ) tests, followed by (order randomized) two incremental exercise protocols (3-min stages at 35%, 50%, 65%, 80%, 95% VO 2max  ). Continuous measures of middle cerebral artery velocity (MCAv), oxygen consumption, end-tidal CO 2  (P ET  CO 2  ), and heart rate were obtained. Modality-specific MCAv changes were observed for the whole group (interaction effect: p = .01). Exercise-induced increases in MCAv mean  during cycling followed an inverted-U pattern, peaking at 65% VO 2max  (Δ12 ± 7 cm/s from rest), whereas MCAv mean  during running increased linearly up to 95% VO 2max  (change from rest: Δ12 ± 13 vs. Δ7 ± 8 cm/s for running vs. cycling at 95% VO 2max  ; p = .01). In contrast, both modalities had an inverted-U pattern for P ET  CO 2  changes, although peaked at different intensities (running: 50% VO 2max  , Δ6 ± 2 mmHg; cycling: 65% VO 2max  , Δ7 ± 2 mmHg; interaction effect: p = .01). Further subgroup analysis revealed that the running-specific linear MCAv mean  response was fitness dependent (Fitness*modality*intensity interaction effect: p = .04). Above 65% VO 2max  , fitter participants (n = 16; male > 45 mL/min/kg and female > 40 mL/min/kg) increased MCAv mean  up to 95% VO 2max  , whereas in unfit participants (n = 7, male < mL/min/kg and female < 35 mL/min/kg) MCAv mean  returned toward resting values. Findings demonstrate that modality- and fitness-specific profiles for MCAv mean  are seen at exercise intensities exceeding 65% VO 2max  .",2020,Modality-specific MCAv changes were observed for the whole group (interaction effect: p = .01).,"['\xa035', 'Twenty-six participants (12 females; age: 26\xa0±\xa08\xa0years) completed four']","['exercise sessions; two mode-specific maximal oxygen consumption (VO 2max  ) tests, followed by (order randomized) two incremental exercise protocols']","['MCAv mean  during running', 'cerebral blood velocity', 'middle cerebral artery velocity (MCAv), oxygen consumption, end-tidal CO 2  (P ET  CO 2  ), and heart rate', 'CBF velocity responses', 'MCAv mean', 'Modality-specific MCAv changes']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0149566', 'cui_str': 'Structure of middle cerebral artery'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",26.0,0.153495,Modality-specific MCAv changes were observed for the whole group (interaction effect: p = .01).,"[{'ForeName': 'Rhodri J', 'Initials': 'RJ', 'LastName': 'Furlong', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Weaver', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Sutherland', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Claire V', 'Initials': 'CV', 'LastName': 'Burley', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Gabriella M', 'Initials': 'GM', 'LastName': 'Imi', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Rebekah A I', 'Initials': 'RAI', 'LastName': 'Lucas', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Samuel J E', 'Initials': 'SJE', 'LastName': 'Lucas', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, College of Life and Environmental Sciences, University of Birmingham, Birmingham, UK.'}]",Physiological reports,['10.14814/phy2.14539']
1927,32787783,A randomised dose-response study of prophylactic Methoxamine infusion for preventing spinal-induced hypotension during Cesarean delivery.,"BACKGROUND


α-receptor agonists have been reported to be safe and effective for treating or preventing spinal-induced hypotension during cesarean delivery. As a pure α 1  adrenergic agonist, methoxamine has potential advantages of reducing myocardial oxygen consumption and protecting the heart in obstetric patients compared to phenylephrine. The aim of this study was to determine the optimal prophylactic methoxamine infusion dose that would be effective for preventing spinal-induced hypotension in 50% (ED 50 ) and 95% (ED 95 ) of parturients.
METHODS


Eighty parturients with a singleton pregnancy scheduled for elective cesarean delivery were randomly allocated to receive prophylactic methoxamine infusion at one of four different fixed-rates: 1 μg/kg/min (group M1), 2 μg/kg/min (group M2), 3 μg/kg/min (group M3), or 4 μg/kg/min (group M4). An adequate response was defined as absence of hypotension (maternal SBP < 80% of baseline or SBP < 90 mmHg). The values for ED 50  and ED 95  of prophylactic methoxamine infusion were determined by probit regression model. The outcomes of maternal hemodynamics and fetal status were compared among the groups.
RESULTS


The calculated ED 50  and ED 95  (95% confidence interval) of prophylactic methoxamine infusion dose were 2.178 (95% CI 1.564 to 2.680) μg/kg/min and 4.821 (95% CI 3.951 to 7.017) μg/kg/min, respectively. The incidence of hypotension decreased with increasing methoxamine infusion dose (15/20, 11/20, 7/20 and 2/20 in group M1, M2, M3 and M4 respectively, P <  0.001). 1-min Apgar scores and umbilical arterial PaO2 were lower but umbilical arterial PaCO2 was higher in Group M1. No difference was found in the other incidence of adverse effects and neonatal outcomes among groups.
CONCLUSIONS


Under the conditions of this study, when prophylactic methoxamine infusion was given at a fixed-rate based on body weight for preventing spinal-induced hypotension in obstetric patients, the values for ED 50  and ED 95  were 2.178 μg/kg/min and 4.821 μg/kg/min respectively.
CLINICAL TRIAL REGISTRATION


Chinese Clinical Trial Registry (ChiCTR), registry number of clinical trial: ChiCTR-1,800,018,988 , date of registration: October 20, 2018.",2020,1-min Apgar scores and umbilical arterial PaO2 were lower but umbilical arterial PaCO2 was higher in Group M1.,"['spinal-induced hypotension during Cesarean delivery', 'Eighty parturients with a singleton pregnancy scheduled for elective cesarean delivery']","['prophylactic methoxamine infusion', 'prophylactic methoxamine', 'prophylactic Methoxamine infusion', 'phenylephrine']","['adverse effects and neonatal outcomes', 'myocardial oxygen consumption', '1-min Apgar scores and umbilical arterial PaO2', 'incidence of hypotension', 'maternal hemodynamics and fetal status', 'spinal-induced hypotension', 'umbilical arterial PaCO2']","[{'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0025681', 'cui_str': 'Methoxamine'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0428863', 'cui_str': 'Myocardial oxygen consumption'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",,0.308116,1-min Apgar scores and umbilical arterial PaO2 were lower but umbilical arterial PaCO2 was higher in Group M1.,"[{'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Fu', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Rd 1#, Hangzhou, China.""}, {'ForeName': 'Yu-Wen', 'Initials': 'YW', 'LastName': 'Tang', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Rd 1#, Hangzhou, China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Rd 1#, Hangzhou, China.""}, {'ForeName': 'Cui-Cui', 'Initials': 'CC', 'LastName': 'Jiao', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Rd 1#, Hangzhou, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Ma', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Rd 1#, Hangzhou, China.""}, {'ForeName': 'Xin-Zhong', 'Initials': 'XZ', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesia, Women's Hospital, Zhejiang University School of Medicine, Xueshi Rd 1#, Hangzhou, China. chenxinz@zju.edu.cn.""}]",BMC anesthesiology,['10.1186/s12871-020-01119-2']
1928,32787809,An examination of the socio-demographic correlates of patient adherence to self-management behaviors and the mediating roles of health attitudes and self-efficacy among patients with coexisting type 2 diabetes and hypertension.,"BACKGROUND


Patients with coexisting type 2 diabetes and hypertension generally exhibit poor adherence to self-management, which adversely affects their disease control. Therefore, identification of the factors related to patient adherence is warranted. In this study, we aimed to examine (i) the socio-demographic correlates of patient adherence to a set of self-management behaviors relevant to type 2 diabetes and hypertension, namely, medication therapy, diet therapy, exercise, tobacco and alcohol avoidance, stress reduction, and self-monitoring/self-care, and (ii) whether health attitudes and self-efficacy in performing self-management mediated the associations between socio-demographic characteristics and adherence.
METHODS


We performed a secondary analysis of data collected in a randomized controlled trial. The sample comprised 148 patients with coexisting type 2 diabetes mellitus and hypertension. Data were collected by a questionnaire and analyzed using logistic regression.
RESULTS


Female patients were found to be less likely to exercise regularly (odds ratio [OR] = 0.49, P = 0.03) and more likely to avoid tobacco and alcohol (OR = 9.87, P < 0.001) than male patients. Older patients were found to be more likely to adhere to diet therapy (OR = 2.21, P = 0.01) and self-monitoring/self-care (OR = 2.17, P = 0.02). Patients living with family or others (e.g., caregivers) were found to be more likely to exercise regularly (OR = 3.44, P = 0.02) and less likely to avoid tobacco and alcohol (OR = 0.10, P = 0.04) than those living alone. Patients with better perceived health status were found to be more likely to adhere to medication therapy (OR = 2.02, P = 0.03). Patients with longer diabetes duration (OR = 2.33, P = 0.01) were found to be more likely to adhere to self-monitoring/self-care. Self-efficacy was found to mediate the association between older age and better adherence to diet therapy, while no significant mediating effects were found for health attitudes.
CONCLUSIONS


Adherence to self-management was found to be associated with socio-demographic characteristics (sex, age, living status, perceived health status, and diabetes duration). Self-efficacy was an important mediator in some of these associations, suggesting that patient adherence may be improved by increasing patients' self-management efficacy, such as by patient empowerment, collaborative care, or enhanced patient-physician interactions.",2020,"Older patients were found to be more likely to adhere to diet therapy (OR = 2.21, P = 0.01) and self-monitoring/self-care (OR = 2.17, P = 0.02).","['Patients with coexisting type 2 diabetes and hypertension', 'Older patients', 'patients with coexisting type 2 diabetes and hypertension', 'Female patients', '148 patients with coexisting type 2 diabetes mellitus and hypertension', 'Patients living with family or others (e.g., caregivers']",[],"['socio-demographic characteristics (sex, age, living status, perceived health status, and diabetes duration', 'Self-efficacy', 'avoid tobacco and alcohol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0557130', 'cui_str': 'Lives with family'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}]",[],"[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}]",148.0,0.0208778,"Older patients were found to be more likely to adhere to diet therapy (OR = 2.21, P = 0.01) and self-monitoring/self-care (OR = 2.17, P = 0.02).","[{'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Department of Industrial and Manufacturing Systems Engineering, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Industrial and Manufacturing Systems Engineering, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Or', 'Affiliation': 'Department of Industrial and Manufacturing Systems Engineering, The University of Hong Kong, Hong Kong, China. klor@hku.hk.'}, {'ForeName': 'Jiayin', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Industrial and Manufacturing Systems Engineering, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Mian', 'Initials': 'M', 'LastName': 'Yan', 'Affiliation': 'School of Intelligent Systems Science and Engineering, Jinan University, Zhuhai, China.'}, {'ForeName': 'Hailiang', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Systems Engineering and Engineering Management, City University of Hong Kong, Hong Kong, China.'}]",BMC public health,['10.1186/s12889-020-09274-4']
1929,32787819,Correction to: Persistent physical symptoms reduction intervention: a system change and evaluation in secondary care (PRINCE secondary) - a CBT-based transdiagnostic approach: study protocol for a randomised controlled trial.,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,[],[],[],[],[],[],,0.0793028,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Trudie', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK. trudie.chalder@kcl.ac.uk.""}, {'ForeName': 'Meenal', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'James', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hotopf', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Frank', 'Affiliation': 'Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Watts', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, 16 De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': ""Health Economics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'David', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ashworth', 'Affiliation': ""Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Mujtaba', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'South London and Maudsley NHS Foundation Trust, London, UK.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Garrood', 'Affiliation': ""Department of Rheumatology, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""School of Health Psychology Section, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",BMC psychiatry,['10.1186/s12888-020-02811-w']
1930,32792762,The Effect of Human Chorionic Gonadotropin on the  In vitro  Development of Immature to Mature Human Oocytes: A Randomized Controlled Study.,"Context


In controlled ovarian hyperstimulation cycles, 15% of oocytes have been proven to be immature. Key factors include failure in signal transmission from the cumulus cell to the oocyte, insufficient level of luteinizing hormone, and internal conditions of the oocyte itself.
Aims


The aim of the present study was to investigate the effect of human chorionic gonadotropin (hCG) on the  in vitro  maturity of partially cumulus-denuded immature oocytes collected after controlled ovarian stimulation for  in vitro  fertilization (IVF).
Settings and Design


This was a prospective, randomized controlled design at the department of obstetrics and gynaecology, university hospital.
Subjects and Methods


Infertile women underwent gonadotropin-releasing hormone antagonist stimulated protocol for IVF with final maturation triggered by hCG, partially cumulus-denuded immature human oocytes were allocated to two groups: the first was treated with fertilization medium and the second was treated with fertilization medium and hCG. They were cultured for 24 h. Outcomes measured were the oocyte maturation rates to metaphase II (MII) and glucose-6-phosphate dehydrogenase (G6PD) activity of  in vitro  maturation (IVM) mature oocytes which represent the oocyte quality.
Statistical Analysis Used


The Mann-Whitney U-test and One-way ANOVA were used to compare continuous variables, and Chi-square was used for categorical data.
Results


In all, 250 immature stimulated oocytes were allocated (125 per group). The maturation rate was higher in the hCG supplement group (48% vs. 39.2%) without significance. The positive brilliant cresyl blue results among the MII oocytes developed from the metaphase I (MI) were significantly higher in the hCG group ( P  = 0.001).
Conclusions


Rescue IVM in fertilization culture medium plus hCG was slightly better than that in the only fertilization culture. MII oocytes developed from MI in hCG supplemented medium had a higher quality based on the measured G6PD activity.",2020,The maturation rate was higher in the hCG supplement group (48% vs. 39.2%) without significance.,"['Immature to Mature Human Oocytes', '250 immature stimulated oocytes', 'for IVF with final maturation triggered by hCG, partially cumulus-denuded immature human oocytes', 'Subjects and Methods\n\n\nInfertile women underwent', 'department of obstetrics and gynaecology, university hospital', 'vitro  maturity of partially cumulus-denuded immature oocytes collected after controlled ovarian stimulation for  in vitro  fertilization (IVF']","['Human Chorionic Gonadotropin', 'fertilization medium and the second was treated with fertilization medium and hCG', 'human chorionic gonadotropin (hCG', 'gonadotropin-releasing hormone antagonist stimulated protocol', 'hCG']","['oocyte maturation rates to metaphase II (MII) and glucose-6-phosphate dehydrogenase (G6PD) activity of  in vitro  maturation (IVM) mature oocytes which represent the oocyte quality', 'maturation rate', 'G6PD activity', 'metaphase I (MI']","[{'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0029974', 'cui_str': 'Ovum'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1274104', 'cui_str': 'Obstetrics and gynecology'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}]","[{'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C0017757', 'cui_str': 'Glucose-6-phosphate dehydrogenase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0427508', 'cui_str': 'Glucose-6-phosphate dehydrogenase measurement, quantitative'}]",250.0,0.0948052,The maturation rate was higher in the hCG supplement group (48% vs. 39.2%) without significance.,"[{'ForeName': 'Chananya', 'Initials': 'C', 'LastName': 'Tantitham', 'Affiliation': 'Department of Obstetrics and Gynaecology, Reproductive Endocrinology and Infertility Unit, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sitanan', 'Initials': 'S', 'LastName': 'Panunumpa', 'Affiliation': 'Department of Obstetrics and Gynaecology, Reproductive Endocrinology and Infertility Unit, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chonthicha', 'Initials': 'C', 'LastName': 'Satirapod', 'Affiliation': 'Department of Obstetrics and Gynaecology, Reproductive Endocrinology and Infertility Unit, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of human reproductive sciences,['10.4103/jhrs.JHRS_1_20']
1931,32792765,Follicular Flushing Versus Direct Aspiration at Oocyte Retrieval in Poor Responders Undergoing  in vitro  Fertilization: A Randomized Controlled Trial.,"Aim


This study aims to study the effect of follicular flushing at oocyte retrieval on Assisted Reproductive Technique (ART) outcomes in poor responders undergoing  in vitro  fertilization.
Settings and Design


A prospective randomized controlled trial was conducted in the ART center of our hospital.
Materials and Methods


A total of 71 patients who responded poorly during controlled ovarian stimulation were recruited. Patients were randomized to follicular flushing or to direct aspiration group. The primary outcomes of the study were the total number of oocytes retrieved and the number of metaphase (M II) oocytes retrieved. Secondary outcomes were anesthesia time, procedure time, fertilization rate, cleavage rate, total number of embryos, number of embryos transferred, number of Grade 1 embryos, failed oocyte recovery, failed fertilization, implantation rate, clinical pregnancy rate, miscarriage rate, and live birth rate.
Statistical Analysis Used


Chi-square test and Student's  t -test.
Results


The total number of oocytes retrieved, number of M II oocytes, fertilization rate, cleavage rate, total number of embryos, number of Grade 1 embryos, failed oocyte recovery, failed fertilization, implantation rate, miscarriage rate, and live birth rate were comparable between the two groups. The anesthesia and procedure time was significantly higher in the flushing group.
Conclusions


Follicular flushing does not result in a significant improvement in the ART outcomes despite increasing procedure and anesthesia times.Trial registration number CTRI/2017/07/009062.",2020,"The anesthesia and procedure time was significantly higher in the flushing group.
","['71 patients who responded poorly during controlled ovarian stimulation were recruited', 'poor responders undergoing  in vitro  fertilization', 'Poor Responders Undergoing  in vitro  Fertilization']","['follicular flushing at oocyte retrieval', 'follicular flushing or to direct aspiration group', 'Follicular Flushing Versus Direct Aspiration at Oocyte Retrieval']","['total number of oocytes retrieved and the number of metaphase (M II) oocytes retrieved', 'total number of oocytes retrieved, number of M II oocytes, fertilization rate, cleavage rate, total number of embryos, number of Grade 1 embryos, failed oocyte recovery, failed fertilization, implantation rate, miscarriage rate, and live birth rate', 'anesthesia time, procedure time, fertilization rate, cleavage rate, total number of embryos, number of embryos transferred, number of Grade 1 embryos, failed oocyte recovery, failed fertilization, implantation rate, clinical pregnancy rate, miscarriage rate, and live birth rate', 'anesthesia and procedure time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C3160898', 'cui_str': 'Controlled ovarian stimulation'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}]","[{'cui': 'C0439682', 'cui_str': 'Follicular'}, {'cui': 'C0016382', 'cui_str': 'Flushing'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449803', 'cui_str': 'Number of oocytes'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1621812', 'cui_str': 'Metaphase'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0449951', 'cui_str': 'Number of embryos transferred'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",71.0,0.269925,"The anesthesia and procedure time was significantly higher in the flushing group.
","[{'ForeName': 'Neena', 'Initials': 'N', 'LastName': 'Malhotra', 'Affiliation': 'Department of Obstetrics and Gynaecology, ART Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Chithira Pulimoottil', 'Initials': 'CP', 'LastName': 'Vignarajan', 'Affiliation': 'Department of Obstetrics and Gynaecology, ART Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Disket', 'Initials': 'D', 'LastName': 'Dolkar', 'Affiliation': 'Department of Obstetrics and Gynaecology, ART Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Reeta', 'Initials': 'R', 'LastName': 'Mahey', 'Affiliation': 'Department of Obstetrics and Gynaecology, ART Center, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Perumal', 'Initials': 'P', 'LastName': 'Vanamail', 'Affiliation': 'Department of Obstetrics and Gynaecology, ART Center, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of human reproductive sciences,['10.4103/jhrs.JHRS_59_19']
1932,32792771,Comparative Evaluation of Therapeutic Efficacy of Intralesional Injection of Triamcinolone Acetonide versus Intralesional Autologous Platelet-rich Plasma Injection in Alopecia Areata.,"Context


Alopecia areata is a chronic non-scarring alopecia that involves scalp and/or body. Corticosteroids are the most popular drugs for its treatment.
Aim


The aim of the study was to evaluate the therapeutic efficacy of intralesional injection of triamcinolone acetonide and platelet-rich plasma (PRP) in alopecia areata and to compare the efficacy of these modalities in alopecia areata.
Settings and Design


This was a randomized controlled comparative study.
Subjects and Methods


Forty patients were enrolled from the outpatient department and divided into two groups of 20 patients each. Group A and B randomly received intradermal triamcinolone acetonide suspension (10 mg/mL) and PRP, respectively, into the lesion using an insulin syringe in multiple 0.1 mL injections 1cm apart. The injections were repeated every 3 weeks till 12 weeks. The patients were evaluated by Severity of Alopecia Tool (SALT) score and photographically every 3 weeks till the end of 12 weeks and then at the end of 6 months. Statistical analysis used descriptive analysis along with Pearson chi-square test or Fisher exact test, paired samples, and independent samples  t  test or their nonparametric analogs for continuous variables.
Results


The reduction in SALT score at each visit with respect to baseline was greater in the triamcinolone group as compared to PRP group. This signifies greater effect of triamcinolone in alopecia areata. Around 50% patients in triamcinolone group and 5% patients in PRP group showed grade V improvement. Pain during intralesional injection was higher in the PRP group.
Conclusion


Both intralesional triamcinolone and PRP were found to be efficacious in alopecia areata but the latter produced lesser improvement.",2020,The reduction in SALT score at each visit with respect to baseline was greater in the triamcinolone group as compared to PRP group.,"['Subjects and Methods\n\n\nForty patients were enrolled from the outpatient department and divided into two groups of 20 patients each', 'Alopecia Areata', 'alopecia areata']","['PRP', 'triamcinolone', 'intralesional triamcinolone', 'Triamcinolone Acetonide', 'Corticosteroids', 'intradermal triamcinolone acetonide suspension', 'Intralesional Autologous Platelet-rich Plasma Injection', 'triamcinolone acetonide and platelet-rich plasma (PRP']","['Severity of Alopecia Tool (SALT) score', 'grade V improvement', 'Pain', 'SALT score', 'alopecia areata']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",40.0,0.0244309,The reduction in SALT score at each visit with respect to baseline was greater in the triamcinolone group as compared to PRP group.,"[{'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Kapoor', 'Affiliation': 'Department of Dermatology, Guru Gobind Singh Medical College and Hospital, Faridkot, India.'}, {'ForeName': 'Sumir', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Department of Dermatology, Guru Gobind Singh Medical College and Hospital, Faridkot, India.'}, {'ForeName': 'Balvinder K', 'Initials': 'BK', 'LastName': 'Brar', 'Affiliation': 'Department of Dermatology, Guru Gobind Singh Medical College and Hospital, Faridkot, India.'}, {'ForeName': 'Neetu', 'Initials': 'N', 'LastName': 'Kukar', 'Affiliation': 'Department of Immunohaematology and Blood Transfusion, Guru Gobind Singh Medical College and Hospital, Faridkot, India.'}, {'ForeName': 'Hobinder', 'Initials': 'H', 'LastName': 'Arora', 'Affiliation': 'Department of Community Medicine, Guru Gobind Singh Medical College and Hospital, Faridkot, India.'}, {'ForeName': 'Sukhmani K', 'Initials': 'SK', 'LastName': 'Brar', 'Affiliation': 'Department of Dermatology, Adesh Institute of Medical Sciences and Research, Bathinda, Punjab, India.'}]",Journal of cutaneous and aesthetic surgery,['10.4103/JCAS.JCAS_16_19']
1933,32792818,Comparative Evaluation of the Remineralizing Potential of Commercially Available Agents on Artificially Demineralized Human Enamel: An  In vitro  Study.,"Background


Caries is highly prevalent multifactorial disease, but its progression can be prevented in the initial stage of demineralization through remineralization (RML). Various materials have been proposed for the same, successful outcome can prove to be a boon in the prevention of caries.
Aim


The aim of the study is to assess the RML potential of four commercially available agents so as to restore the enamel closest to its previous microhardness levels.
Materials and Methods


Sixty permanent intact premolars were randomly divided into six groups: Four test groups - (1) bioactive glass (BAG) Novamin (SHY-NM), (2) nano-hydroxyapatite (nHAp) (Acclaim), (3) functionalized tricalcium phosphate (f-TCP) (Clinpro Tooth Crème), and (4) grape seed extract (GSE); one positive control - (5) fluoride (1000 ppm) containing dentifrice (Colgate Calci-Lock); and one negative control - (6) distilled water. The samples were initially evaluated for baseline surface microhardness (SMH); later on, these samples were placed in the demineralizing solution for 48 h in an incubator at 37°C, and postdemineralization again SMH was measured. Thereafter, the samples were subjected to the pH cycling for consecutive 21 days, and SMH was recorded. The SMH was evaluated using a Vickers microhardness tester. Statistical analysis was done using a  post hoc  Tukey test for each group based on the stage of treatment and one-way ANOVA for comparison among different groups.
Results


BAG Novamin showed SMH recovery at 96.75% followed by f-TCP at 95.83%, nHAp at 90.88%, and GSE at 48.71%. Statistically significant differences were observed between the first three groups and the rest of the groups after RML stage.
Conclusion


BAG Novamin, f-TCP, and nHAp showed considerable RML followed to a lesser extent by GSE.",2019,"Various materials have been proposed for the same, successful outcome can prove to be a boon in the prevention of caries.
","['Artificially Demineralized Human Enamel', 'Materials and Methods\n\n\nSixty permanent intact premolars']","['bioactive glass (BAG) Novamin (SHY-NM), (2) nano-hydroxyapatite (nHAp) (Acclaim), (3) functionalized tricalcium phosphate (f-TCP) (Clinpro Tooth Crème), and (4) grape seed extract (GSE); one positive control - (5) fluoride (1000 ppm) containing dentifrice (Colgate Calci-Lock); and one negative control - (6) distilled water']",['SMH recovery'],"[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C1722474', 'cui_str': 'NovaMin'}, {'cui': 'C0557869', 'cui_str': 'Introvert'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C0108136', 'cui_str': 'tricalcium phosphate'}, {'cui': 'C0044091', 'cui_str': '1-(1-(2-thienyl) cyclohexyl) piperidine'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0772454', 'cui_str': 'Grape Seed Extract'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C2345900', 'cui_str': 'Colgate'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]",[],,0.0337348,"Various materials have been proposed for the same, successful outcome can prove to be a boon in the prevention of caries.
","[{'ForeName': 'Chintan', 'Initials': 'C', 'LastName': 'Joshi', 'Affiliation': 'Department of Conservative and Endodontics, Karnavati School of Dentistry, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Gohil', 'Affiliation': 'Department of Conservative and Endodontics, Karnavati School of Dentistry, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Parekh', 'Affiliation': 'Department of Conservative and Endodontics, Karnavati School of Dentistry, Ahmedabad, Gujarat, India.'}, {'ForeName': 'Surabhi', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Department of Periodontics, Karnavati School of Dentistry, Ahmedabad, Gujarat, India.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_679_18']
1934,32792820,Volumetric Analysis of Root Canal Filling in Deciduous Teeth after Using Different Canal-Drying Methods: An  In-vitro  Study.,"Background


Drying the root canals in pulp therapy is often ignored, but is essential for a successful clinical outcome. The conventional method used for drying root canals is by the use of paper points, but recently, various other methods have also been employed for this purpose.
Aim


The purpose of this study was to volumetrically analyze root canal fillings in deciduous teeth, after using different canal-drying methods namely 95% ethanol, CANAL CLEAN (Cerkamed Medical Company), and Endo-Aspirator (Cerkamed Medical Company), and compare with the conventional paper point drying method.
Methodology


Access cavities were prepared on eighty extracted primary canines, and irrigation was done with 1% sodium hypochlorite and normal saline while enlarging the canals. The specimens were then scanned using a cone-beam computed tomography (CBCT), and preobturation volume (X) of each tooth was measured. The teeth were then randomly divided into two groups - Group 1 - Zinc oxide eugenol (ZOE) group and Group 2 - Metapex group. Each group was further divided randomly into four subgroups based on the drying agent used - Subgroup A - Control group, Subgroup B - 95% ethanol group, Subgroup C - CANAL CLEAN group, and Subgroup D - Endo-Aspirator group. After obturation, a second CBCT was taken to measure the postobturation volume (Y). The percentage of obturated volume was calculated by the following formula: (postobturation volume/preobturation volume) ×100 ([ Y / X ] ×100).
Statistical Analysis


The obtained data were tabulated and subjected to statistical analysis using one-way ANOVA test and unpaired  t -test.
Results


A significantly high postobturation volume was seen after using 95% ethanol followed by CANAL CLEAN, Endo-Aspirator, and paper points. On comparing the obturation volumes within Metapex and ZOE groups, Metapex group had significantly high obturation volumes irrespective of the drying method used.
Conclusion


95% ethanol is the best intracanal drying agent as it provides optimum pupal obturation.",2019,"A significantly high postobturation volume was seen after using 95% ethanol followed by CANAL CLEAN, Endo-Aspirator, and paper points.",[],"['Zinc oxide eugenol (ZOE) group and Group 2 - Metapex group', 'sodium hypochlorite and normal saline while enlarging the canals', 'canal-drying methods namely 95% ethanol, CANAL CLEAN (Cerkamed Medical Company), and Endo-Aspirator (Cerkamed Medical Company', 'drying agent used - Subgroup A - Control group, Subgroup B - 95% ethanol group, Subgroup C - CANAL CLEAN group, and Subgroup D - Endo-Aspirator group']",['percentage of obturated volume'],[],"[{'cui': 'C0043492', 'cui_str': 'Zinc oxide eugenol dental cement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C1567041', 'cui_str': 'Metapex'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0042226', 'cui_str': 'Aspirator'}, {'cui': 'C2936384', 'cui_str': 'Drying Agents'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",80.0,0.0205323,"A significantly high postobturation volume was seen after using 95% ethanol followed by CANAL CLEAN, Endo-Aspirator, and paper points.","[{'ForeName': 'C S Sri', 'Initials': 'CSS', 'LastName': 'Darshini', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, A.E.C.S Maaruti College of Dental Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Preetha', 'Initials': 'P', 'LastName': 'Peethambar', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, A.E.C.S Maaruti College of Dental Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Konde', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, A.E.C.S Maaruti College of Dental Sciences, Bengaluru, Karnataka, India.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Agarwal', 'Affiliation': 'Department of Pediatric and Preventive Dentistry, A.E.C.S Maaruti College of Dental Sciences, Bengaluru, Karnataka, India.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_896_18']
1935,32792824,Efficacy of Platelet-rich Fibrin in Interdental Papilla Reconstruction as Compared to Connective Tissue Using Microsurgical Approach.,"Aim


This study aims to evaluate autologous platelet-rich fibrin (PRF) and autogenous connective tissue graft (CTG) in interdental papilla (IDP) reconstruction with buccal and palatal split-thickness flap (STF) using microsurgical technique.
Materials and Methods


Forty Class I or Class II open gingival or cervical embrasure in maxillary anterior region in 14 patients were surgical treated for the reconstruction of IDP. For experimental Group I (STF with PRF,  n  = 20), surgical site was flushed with PRF fluid. PRF was then placed under the buccal flap and in the IDP region and squeezed. For experimental Group II (STF with CTG,  n  = 20) after the preparation of recipient site, CTG procured from palate was trimmed to the desired size and shape and placed at the site. Clinical parameters and patient satisfaction response recorded were plaque index, gingival index, probing pocket depth, clinical attachment level, height of IPD, and papilla index score (PIS).
Results


STF surgery in combination with PRF or CTG, are an effective procedure to increase IDP-height with mean values of 3.10 mm (87.3%) and 3.45 mm (95.8%) for Group I (STF + PRF) and Group II (STF + CTG), respectively. In terms of complete fill (CF) achieved at 3 months, in the present study, the result showed that 90% CF was obtained in Group I (STF + PRF) and 95% in Group II (STF + CTG). The patient response and acceptance for surgical treatment modality in terms of patient postsurgical discomfort score and patient esthetic score was higher for Group II (STF + CTG) than Group I (STF + PRF).
Conclusion


Based on single-centered 3 months' follow-up, it may be concluded that STF surgery in combination with PRF or CTG is an effective procedure to increase IDP-height; however, a long-term multicentric randomized clinical trial may be necessary to evaluate the clinical outcome for autologous PRF in comparison to CTG with STF.",2019,"Results


STF surgery in combination with PRF or CTG, are an effective procedure to increase IDP-height with mean values of 3.10 mm (87.3%) and 3.45 mm (95.8%) for Group I (STF + PRF) and Group II (STF + CTG), respectively.",['14 patients were surgical treated for the reconstruction of IDP'],"['buccal and palatal split-thickness flap (STF', 'Platelet-rich Fibrin', 'autologous platelet-rich fibrin (PRF) and autogenous connective tissue graft (CTG', 'Materials and Methods\n\n\nForty Class I or Class II open gingival or cervical embrasure', 'PRF or CTG']","['IDP-height', 'patient postsurgical discomfort score and patient esthetic score', 'plaque index, gingival index, probing pocket depth, clinical attachment level, height of IPD, and papilla index score (PIS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C1185949', 'cui_str': 'Structure of interdental papilla of gingiva'}]","[{'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1291062', 'cui_str': 'Embrasure'}]","[{'cui': 'C1185949', 'cui_str': 'Structure of interdental papilla of gingiva'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0226964', 'cui_str': 'Structure of lingual papillae'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",14.0,0.0499324,"Results


STF surgery in combination with PRF or CTG, are an effective procedure to increase IDP-height with mean values of 3.10 mm (87.3%) and 3.45 mm (95.8%) for Group I (STF + PRF) and Group II (STF + CTG), respectively.","[{'ForeName': 'Dhanavendra', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Department of Periodontology, Saraswati Dental College, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Jhingran', 'Affiliation': 'Department of Periodontology, Saraswati Dental College, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Vivek Kumar', 'Initials': 'VK', 'LastName': 'Bains', 'Affiliation': 'Department of Periodontology, Saraswati Dental College, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Madan', 'Affiliation': 'Department of Periodontology, Saraswati Dental College, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Ruchi', 'Initials': 'R', 'LastName': 'Srivastava', 'Affiliation': 'Department of Periodontology, Saraswati Dental College, Lucknow, Uttar Pradesh, India.'}]",Contemporary clinical dentistry,['10.4103/ccd.ccd_936_18']
1936,32792897,Implementing Mobile HRV Biofeedback as Adjunctive Therapy During Inpatient Psychiatric Rehabilitation Facilitates Recovery of Depressive Symptoms and Enhances Autonomic Functioning Short-Term: A 1-Year Pre-Post-intervention Follow-Up Pilot Study.,"Objective


New treatment options for depression are warranted, due to high recurrence rates. Recent research indicates benefits of heart rate variability biofeedback (HRVBF) on symptom recovery and autonomic functioning in depressed individuals. Slow-paced breathing-induced amplification of vagus nerve activity is the main element of HRVBF. Thus, the latter represents a safe and non-invasive complementary depression treatment. However, its efficacy in patients undergoing inpatient psychiatric rehabilitation receiving highly comprehensive treatments has not been evaluated.
Methods


Ninety-two inpatients were randomly assigned to an intervention group (IG) or control group (CG). While the latter received the standard treatment only, adjunctive HRVBF was provided to the IG over 5 weeks. Depression severity and heart rate variability (HRV) were assessed before (pre) and after 5 weeks (post). Moreover, 1-year follow-up depression scores were available for 30 participants.
Results


Although depression improved in both groups, the IG exhibited significantly larger improvements at post-assessment (  η   p   2    = 0.065) and significant increases in resting LF-HRV ( d  = 0.45) and cardiorespiratory coherence ( d  = 0.61). No significant effects for RMSSD, SDNN, HF-HRV, or HR were found ( p s > 0.05). Additionally, the IG showed a medium- to large-sized reduction in resting respiratory rate from 13.2 to 9.8 breaths per minute ( p  < 0.001,  d  = 0.86), with the CG exhibiting only a small decrease from 13.5 to 12.4 ( p  = 0.49;  d  = 0.35). While the IG exhibited significantly lower depression scores at post-assessment ( p  = 0.042,  d  = 0.79), this effect decreased during follow-up ( p  = 0.195,  d  = 0.48).
Conclusion


HRVBF as adjuvant therapy during inpatient psychiatric rehabilitation facilitated depression recovery. Additionally, amplified LF-HRV as well as cardiorespiratory coherence at rest and a decrease in resting breathing frequency was observed in the HRVBF group. These findings emphasize HRVBF's value as complementary therapy regardless of concurrent treatments. Moreover, these incremental benefits could serve as resource even after the actual training period. However, the additional antidepressant gains vanish during the long-term follow-up, indicating the need for more intense training or regular practice afterward, respectively. Thus, future studies are warranted to examine how the initial benefits of HRVBF during inpatient psychiatric rehabilitation can be preserved post discharge.",2020,"No significant effects for RMSSD, SDNN, HF-HRV, or HR were found ( p s > 0.05).","['patients undergoing inpatient psychiatric rehabilitation receiving highly comprehensive treatments', 'depressed individuals', 'Methods\n\n\nNinety-two inpatients']","['heart rate variability biofeedback (HRVBF', 'HRVBF', 'intervention group (IG) or control group (CG', 'Implementing Mobile HRV Biofeedback as Adjunctive Therapy', 'adjunctive HRVBF']","['resting LF-HRV', 'resting breathing frequency', 'depression scores', 'Depression severity and heart rate variability (HRV', '1-year follow-up depression scores', 'symptom recovery and autonomic functioning', 'resting respiratory rate', 'cardiorespiratory coherence', 'RMSSD, SDNN, HF-HRV, or HR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0344315', 'cui_str': 'Depressed mood'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",92.0,0.0379909,"No significant effects for RMSSD, SDNN, HF-HRV, or HR were found ( p s > 0.05).","[{'ForeName': 'Josef M', 'Initials': 'JM', 'LastName': 'Tatschl', 'Affiliation': 'Health Psychology Unit, Institute of Psychology, University of Graz, Graz, Austria.'}, {'ForeName': 'Sigurd M', 'Initials': 'SM', 'LastName': 'Hochfellner', 'Affiliation': 'Privatklinik St. Radegund Betriebs GmbH, St. Radegund, Austria.'}, {'ForeName': 'Andreas R', 'Initials': 'AR', 'LastName': 'Schwerdtfeger', 'Affiliation': 'Health Psychology Unit, Institute of Psychology, University of Graz, Graz, Austria.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00738']
1937,32793080,The Effect of Response Inhibition Training on Risky Decision-Making Task Performance.,"Response inhibition is an important component of executive function and plays an indispensable role in decision-making and other advanced cognitive processes. At the same time, we need an effective way to improve decision-making in the face of complex and limited information. This study mainly explored the influence of response inhibition training on college students' risky decision-making. The recruited students were randomly divided into the training group ( n  = 28) and the control group ( n  = 28). The training group engaged in Go/NoGo and stop-signal tasks for 2 weeks, while the control group was given the task of reading and summarizing popular science articles related to self-control. The Stroop task and Balloon Analog Risk Task were used to evaluate the pretest and posttest performance in inhibitory control and risky decision-making tasks, respectively, for all subjects. The results showed that response inhibition training can be effectively transferred to interference control task performance. The results showed that both the reward acquired and adjusted Balloon Analog Risk Task score (adj BART) significantly improved compared to the pretest in the training group, while the control group showed no significant differences in the reward acquired and the adj BART between the pretest and the posttest. Although response inhibition training increased risky behaviors in the Balloon Analog Risk Task, it substantially reduced overly conservative behaviors and participants gained more money.",2020,"Although response inhibition training increased risky behaviors in the Balloon Analog Risk Task, it substantially reduced overly conservative behaviors and participants gained more money.","[""college students' risky decision-making""]","['training group engaged in Go/NoGo and stop-signal tasks for 2 weeks, while the control group was given the task of reading and summarizing popular science articles related to self-control', 'Response Inhibition Training', 'response inhibition training']","['reward acquired and adjusted Balloon Analog Risk Task score (adj BART', 'risky behaviors', 'reward acquired and the adj BART', 'Risky Decision-Making Task Performance', 'Stroop task and Balloon Analog Risk Task']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}]",,0.0127499,"Although response inhibition training increased risky behaviors in the Balloon Analog Risk Task, it substantially reduced overly conservative behaviors and participants gained more money.","[{'ForeName': 'Pengbo', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Ziwei', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiao', 'Affiliation': ""Department of Medical Psychology, Air Force Medical University, Xi'an, China.""}]",Frontiers in psychology,['10.3389/fpsyg.2020.01806']
1938,32793096,"Effect of a High-Intensity Tandem Bicycle Exercise Program on Clinical Severity, Functional Magnetic Resonance Imaging, and Plasma Biomarkers in Parkinson's Disease.","Rationale:  The optimal modality, intensity, duration, frequency, and dose-response of exercise as a therapy for Parkinson's Disease (PD) are insufficiently understood.  Objective:  To assess the impact of a high-intensity tandem bicycle program on clinical severity, biomarkers, and functional MRI (fMRI) in PD.  Methods:  A single-center, parallel-group clinical trial was conducted. Thirteen PD patients aged 65 or younger were divided in two groups: a control group and an intervention group that incorporated a cycling program at 80% of each individual's maximum heart rate (HR) (≥80 rpm), three times a week, for 16 weeks. Both groups continued their conventional medications for PD. At baseline and at the end of follow-up, we determined in all participants the Unified Parkinson's Disease Rating Scale, anthropometry, VO 2 max, PD biomarkers, and fMRI.  Results:  VO 2 max improved in the intervention group (IG) (+5.7 ml/kg/min), while it slightly deteriorated in the control group (CG) (-1.6 ml/kg/min) ( p  = 0.041). Mean Unified Parkinson's Disease Rating Scale (UPDRS) went down by 5.7 points in the IG and showed a small 0.9-point increase in the CG ( p  = 0.11). fMRI showed activation of the right fusiform gyrus during the motor task and functional connectivity between the cingulum and areas of the frontal cortex, and between the cerebellar vermis and the thalamus and posterior temporal gyrus. Plasma brain-derived neurotrophic factor (BDNF) levels increased more than 10-fold in the IG and decreased in the CG ( p  = 0.028). Larger increases in plasma BDNF correlated with greater decreases in UPDRS ( r  = -0.58,  p  = 0.04).  Conclusions:  Our findings suggest that high-intensity tandem bicycle improves motor function and biochemical and functional neuroimaging variables in PD patients.  Trial registration number:  ISRCTN 13047118, Registered on February 8, 2018.",2020,Mean Unified Parkinson's Disease Rating Scale (UPDRS) went down by 5.7 points in the IG and showed a small 0.9-point increase in the CG ( p  = 0.11).,"[""Parkinson's Disease (PD"", 'PD patients', ""Parkinson's Disease"", 'Thirteen PD patients aged 65 or younger']","['control group and an intervention group that incorporated a cycling program', 'high-intensity tandem bicycle program', 'High-Intensity Tandem Bicycle Exercise Program']","['VO 2 max', 'clinical severity, biomarkers, and functional MRI (fMRI', ""Unified Parkinson's Disease Rating Scale, anthropometry, VO 2 max, PD biomarkers, and fMRI"", 'plasma BDNF', 'motor function and biochemical and functional neuroimaging variables', ""Mean Unified Parkinson's Disease Rating Scale (UPDRS"", 'Plasma brain-derived neurotrophic factor (BDNF) levels', 'UPDRS', 'Clinical Severity, Functional Magnetic Resonance Imaging, and Plasma Biomarkers']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0075804', 'cui_str': 'TANDEM'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C3178877', 'cui_str': 'Functional Neuroimaging'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.062522,Mean Unified Parkinson's Disease Rating Scale (UPDRS) went down by 5.7 points in the IG and showed a small 0.9-point increase in the CG ( p  = 0.11).,"[{'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Segura', 'Affiliation': 'Vida Activa, Department of Internal Medicine, Fundación Santa Fe de Bogotá, Bogota, Colombia.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Eraso', 'Affiliation': 'Vida Activa, Department of Internal Medicine, Fundación Santa Fe de Bogotá, Bogota, Colombia.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bonilla', 'Affiliation': 'School of Medicine and Health Sciences, Universidad del Rosario, Bogota, Colombia.'}, {'ForeName': 'Carlos O', 'Initials': 'CO', 'LastName': 'Mendivil', 'Affiliation': 'School of Medicine, Universidad de los Andes, Bogota, Colombia.'}, {'ForeName': 'Giselle', 'Initials': 'G', 'LastName': 'Santiago', 'Affiliation': 'Radiology and Diagnostic Imaging Department, Fundación Santa Fe de Bogotá, Bogota, Colombia.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Useche', 'Affiliation': 'Radiology and Diagnostic Imaging Department, Fundación Santa Fe de Bogotá, Bogota, Colombia.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Bernal-Pacheco', 'Affiliation': 'Neurology Department, Fundación Santa Fe de Bogotá, Bogota, Colombia.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Monsalve', 'Affiliation': 'Neurosurgery Section, Department of Surgery, Fundación Santa Fe de Bogotá, Bogota, Colombia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Sanchez', 'Affiliation': 'School of Medicine and Health Sciences, Universidad del Rosario, Bogota, Colombia.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Hernández', 'Affiliation': 'School of Medicine and Health Sciences, Universidad del Rosario, Bogota, Colombia.'}, {'ForeName': 'Maria José', 'Initials': 'MJ', 'LastName': 'Peláez-Jaramillo', 'Affiliation': 'School of Medicine, Universidad de los Andes, Bogota, Colombia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Cárdenas-Mojica', 'Affiliation': 'School of Medicine, Universidad de los Andes, Bogota, Colombia.'}]",Frontiers in neurology,['10.3389/fneur.2020.00656']
1939,32793109,"An Exploratory Clinical Study on an Automated, Speed-Sensing Treadmill Prototype With Partial Body Weight Support for Hemiparetic Gait Rehabilitation in Subacute and Chronic Stroke Patients.","Impairments in walking speed, capacity, and endurance are commonly seen after stroke. Treadmill training improves endurance and gait speed. However, the lack of variable training speed and automated speed progression increases the risk of backward displacement and falling. An automated, speed-sensing treadmill prototype with partial body weight support, the Variable Automated Speed and Sensing Treadmill II (VASST II), was tested in an outpatient rehabilitation setting. Eleven subacute or chronic hemiplegics who could ambulate at > 0.2 m/s for >50 m participated in the study. All subjects underwent physiotherapist-supervised training on VASST II for 60 min daily, 3 times per week, for 5 weeks (total 15 h). Outcome measures at Week 3 (mid-VASST II training), Week 6 (post-VASST II training), Week 12 (first follow-up), and Week 24 (second follow-up) included the 6 minute walk test (6 MWT), 10 meter walk test (10 MWT), Berg Balance Scale (BBS) score, and Functional Ambulation category (FAC) score. User acceptability of VASST II for both study subjects and physiotherapists were also assessed. All subjects [median (IQR) age: 53.0 (22) years; median (IQR) duration post-stroke: 524 (811) days] completed VASST II training. At baseline, mean ± SD 6 MWT was 114 ± 50.9 m; mean ± SD 10 MWT was 0.37 ± 0.18 m/s; mean ± SD BBS score was 40 ± 10; and, mean ± SD FAC score was 4 ± 1. At Week 6, there were significant improvements in the 6 MWT [158.91 ± 88.69 m;  P  = 0.003], 10 MWT [0.49 ± 0.30 m/s;  P  = 0.016], and BBS score [42 ± 10;  P  = 0.003]. Improvements in 6 MWT and BBS scores were sustained at Week 24, but not in the 10 MWT. No VASST II-training related falls were reported. All subjects rated their VASST II training positively and indicated that it improved their current walking ability. VASST II training was effective, feasible, and safe in patients with subacute or chronic post-stroke hemiparetic gait, with sustained gains in distance walked (6 MWT) and functional balance (BBS score) up to 19 weeks post-intervention.",2020,"VASST II training was effective, feasible, and safe in patients with subacute or chronic post-stroke hemiparetic gait, with sustained gains in distance walked (6 MWT) and functional balance (BBS score) up to 19 weeks post-intervention.","['Subacute and Chronic Stroke Patients', 'All subjects [median (IQR) age: 53.0 (22) years; median (IQR) duration post-stroke: 524 (811) days] completed VASST II training', 'Eleven subacute or chronic hemiplegics who could ambulate at > 0.2 m', 'patients with subacute or chronic post-stroke hemiparetic gait']","['Treadmill training', 'VASST II training', 'Automated, Speed-Sensing Treadmill Prototype', 'Partial Body Weight Support for Hemiparetic Gait Rehabilitation', 'VASST', 'speed-sensing treadmill prototype with partial body weight support, the Variable Automated Speed and Sensing Treadmill II (VASST II', 'physiotherapist-supervised training on VASST']","['endurance and gait speed', 'walking speed, capacity, and endurance', 'BBS score', 'current walking ability', 'mean ± SD FAC score', '6 minute walk test (6 MWT), 10 meter walk test (10 MWT), Berg Balance Scale (BBS) score, and Functional Ambulation category (FAC) score', 'BBS scores', 'distance walked (6 MWT) and functional balance (BBS score']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.0277495,"VASST II training was effective, feasible, and safe in patients with subacute or chronic post-stroke hemiparetic gait, with sustained gains in distance walked (6 MWT) and functional balance (BBS score) up to 19 weeks post-intervention.","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Chua', 'Affiliation': 'Department of Rehabilitation Medicine, Centre of Advanced Rehabilitation Therapeutics, Tan Tock Seng Hospital Rehabilitation Centre, Singapore, Singapore.'}, {'ForeName': 'Wei Sheong', 'Initials': 'WS', 'LastName': 'Lim', 'Affiliation': 'Department of Rehabilitation Medicine, Centre of Advanced Rehabilitation Therapeutics, Tan Tock Seng Hospital Rehabilitation Centre, Singapore, Singapore.'}, {'ForeName': 'Pang Hung', 'Initials': 'PH', 'LastName': 'Lim', 'Affiliation': 'Department of Rehabilitation Medicine, Centre of Advanced Rehabilitation Therapeutics, Tan Tock Seng Hospital Rehabilitation Centre, Singapore, Singapore.'}, {'ForeName': 'Chien Joo', 'Initials': 'CJ', 'LastName': 'Lim', 'Affiliation': 'Clinical Research & Innovation Office, Tan Tock Seng Hospital, Singapore, Singapore.'}, {'ForeName': 'Chuan Mien', 'Initials': 'CM', 'LastName': 'Hoo', 'Affiliation': 'School of Engineering, Ngee Ann Polytechnic, Singapore, Singapore.'}, {'ForeName': 'Kuang Chua', 'Initials': 'KC', 'LastName': 'Chua', 'Affiliation': 'School of Engineering, Ngee Ann Polytechnic, Singapore, Singapore.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Chee', 'Affiliation': 'School of Engineering, Ngee Ann Polytechnic, Singapore, Singapore.'}, {'ForeName': 'Wai Sing', 'Initials': 'WS', 'LastName': 'Ong', 'Affiliation': 'School of Engineering, Ngee Ann Polytechnic, Singapore, Singapore.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'School of Engineering, Ngee Ann Polytechnic, Singapore, Singapore.'}, {'ForeName': 'Chin Jung', 'Initials': 'CJ', 'LastName': 'Wong', 'Affiliation': 'Department of Rehabilitation Medicine, Centre of Advanced Rehabilitation Therapeutics, Tan Tock Seng Hospital Rehabilitation Centre, Singapore, Singapore.'}]",Frontiers in neurology,['10.3389/fneur.2020.00747']
1940,32793301,Using the GHQ-12 to screen for mental health problems among primary care patients: psychometrics and practical considerations.,"Background


This study explores the factor structure of the Indonesian version of the GHQ-12 based on several theoretical perspectives and determines the threshold for optimum sensitivity and specificity. Through a focus group discussion, we evaluate the practicality of the GHQ-12 as a screening tool for mental health problems among adult primary care patients in Indonesia.
Methods


This is a prospective study exploring the construct validity, criterion validity and reliability of the GHQ-12, conducted with 676 primary care patients attending 28 primary care clinics randomised for participation in the study. Participants' GHQ-12 scores were compared with their psychiatric diagnosis based on face-to-face clinical interviews with GPs using the CIS-R. Exploratory and Confirmatory Factor Analyses determined the construct validity of the GHQ-12 in this population. The appropriate threshold score of the GHQ-12 as a screening tool in primary care was determined using the receiver operating curve. Prior to data collection, a focus group discussion was held with research assistants who piloted the screening procedure, GPs, and a psychiatrist, to evaluate the practicality of embedding screening within the routine clinic procedures.
Results


Of all primary care patients attending the clinics during the recruitment period, 26.7% agreed to participate (676/2532 consecutive patients approached). Their median age was 46 (range 18-82 years); 67% were women. The median GHQ-12 score for our primary care sample was 2, with an interquartile range of 4. The internal consistency of the GHQ-12 was good (Cronbach's α = 0.76). Four factor structures were fitted on the data. The GHQ-12 was found to best fit a one-dimensional model, when response bias is taken into consideration. Results from the ROC curve indicated that the GHQ-12 is 'fairly accurate' when discriminating primary care patients with indication of mental disorders from those without, with average AUC of 0.78. The optimal threshold of the GHQ-12 was either 1/2 or 2/3 point depending on the intended utility, with a Positive Predictive Value of 0.68 to 0.73 respectively. The screening procedure was successfully embedded into routine patient flow in the 28 clinics.
Conclusions


The Indonesian version of the GHQ-12 could be used to screen primary care patients at high risk of mental disorders although with significant false positives if reasonable sensitivity is to be achieved. While it involves additional administrative burden, screening may help identify future users of mental health services in primary care that the country is currently expanding.",2020,"The GHQ-12 was found to best fit a one-dimensional model, when response bias is taken into consideration.","['adult primary care patients in Indonesia', '676 primary care patients attending 28 primary care clinics randomised for participation in the study', 'Their median age was 46', 'primary care patients', 'primary care patients attending the clinics during the recruitment period, 26.7% agreed to participate (676/2532 consecutive patients approached']",['GHQ-12'],"['median GHQ-12 score', 'GHQ-12 scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",676.0,0.017174,"The GHQ-12 was found to best fit a one-dimensional model, when response bias is taken into consideration.","[{'ForeName': 'S G', 'Initials': 'SG', 'LastName': 'Anjara', 'Affiliation': 'Cambridge Institute of Public Health, University of Cambridge, School of Clinical Medicine, Cambridge Biomedical Campus, Forvie Site, Robinson Way, Box 113, Cambridge, CB2 0SR UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bonetto', 'Affiliation': 'Department of Neurosciences, Biomedicine and Movement Sciences, University of Verona, Piazzale L.A. Scuro 10, 37134 Verona, Italy.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Van Bortel', 'Affiliation': 'Cambridge Institute of Public Health, University of Cambridge, School of Clinical Medicine, Cambridge Biomedical Campus, Forvie Site, Robinson Way, Box 113, Cambridge, CB2 0SR UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Brayne', 'Affiliation': 'Cambridge Institute of Public Health, University of Cambridge, School of Clinical Medicine, Cambridge Biomedical Campus, Forvie Site, Robinson Way, Box 113, Cambridge, CB2 0SR UK.'}]",International journal of mental health systems,['10.1186/s13033-020-00397-0']
1941,32793754,Comparison of the effect of electronic education and workshop on the satisfaction of nurses about Emergency Severity Index triage.,"INTRODUCTION


Nurse educators need to develop the level of scientific and practical of the students with the goal of becoming expert nurses. However, the use of modern educational methods to raise the motivation and satisfaction of learners can help individuals achieve this goal. Therefore, the aim of this study was to investigate the effect of health education in emergency nurses about triage.
METHODS


A two-group pool-blind experimental study was performed on seventy emergency nurses. Samples were randomly assigned into two groups: e-learning group (35 individuals = electronic education) and traditional group (35 = workshop education). The demographic questionnaire and the satisfaction questionnaire before and 2 weeks after the intervention in both groups were completed.
RESULTS


Independent  t -test showed that the satisfaction scores before intervention in both e-learning and traditional groups were not statistically significant, whereas there was a significant difference between two groups after 2 weeks after the intervention ( P  = 0/015).
CONCLUSION


Using nursing professors' electronic education programs can increase the level of satisfaction and motivation in the nursing mothers. Therefore, the use of this new educational method is recommended by managers and educational planners as an effective teaching.",2020,"Independent  t -test showed that the satisfaction scores before intervention in both e-learning and traditional groups were not statistically significant, whereas there was a significant difference between two groups after 2 weeks after the intervention ( P  = 0/015).
","['seventy emergency nurses', 'nursing mothers']","['electronic education and workshop', 'health education', 'e-learning group (35 individuals = electronic education) and traditional group (35 = workshop education']","['satisfaction scores', 'demographic questionnaire and the satisfaction questionnaire', 'level of satisfaction and motivation']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",70.0,0.0316878,"Independent  t -test showed that the satisfaction scores before intervention in both e-learning and traditional groups were not statistically significant, whereas there was a significant difference between two groups after 2 weeks after the intervention ( P  = 0/015).
","[{'ForeName': 'Ahmadreza', 'Initials': 'A', 'LastName': 'Yazdannik', 'Affiliation': 'Nursing and Midwifery Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Mohamadirizi', 'Affiliation': 'Nursing and Midwifery Care Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Nasr-Esfahani', 'Affiliation': 'Department of Emergency Medicine, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_182_19']
1942,32793757,The effect of educational intervention based on dramatic literature on parents of elementary schoolchildren skills in sex education.,"BACKGROUND


Today, one of the biggest concerns of parents is protecting their children and properly educating them about sex. The aim of this study was to determine the effect of educational intervention on parental skills in sex education on their children in elementary schools in the northwest of Tehran-Iran in 2019 based on literature.
MATERIALS AND METHODS


This quasi-experimental study was conducted on 125 parents of elementary schoolchildren in the northwestern of Tehran. The data were collected by valid and reliable questionnaire. Before the intervention, two intervention and control groups filled up the pretest questionnaire; the data were collected by valid and reliable questionnaire. Before the intervention, two intervention and control groups filled the pretest questionnaire, and then the parents participated in the educational program based on dramatic literature. Two months later, the same questionnaire was completed by the control and intervention groups. Finally, the data were analyzed by regression and one-way ANOVA test.
RESULTS


The results showed that there was a statistically significant difference between the mean scores of knowledge in the experimental and control groups in the posttest ( P  < 0.01). There was also a statistically significant difference between the mean scores of attitude in the experimental and control groups at the posttest stage ( P  < 0.01). There was also a statistically significant difference between the mean scores of performance based on group membership (experimental group and control group) in the posttest phase ( P  < 0.01).
CONCLUSIONS


The findings of the study showed that educational intervention on parental skills in sex education based on the dramatic literature to their children has significant effect on parental knowledge, attitude, and performance.",2020,There was also a statistically significant difference between the mean scores of attitude in the experimental and control groups at the posttest stage ( P  < 0.01).,"['125 parents of elementary schoolchildren in the northwestern of Tehran', 'sex education on their children in elementary schools in the northwest of Tehran-Iran in 2019 based on literature', 'parents of elementary schoolchildren skills in sex education']",['educational intervention'],"['mean scores of knowledge', 'parental knowledge, attitude, and performance', 'mean scores of performance', 'mean scores of attitude']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0036879', 'cui_str': 'Sexuality education'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023866', 'cui_str': 'Literature'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",,0.0131706,There was also a statistically significant difference between the mean scores of attitude in the experimental and control groups at the posttest stage ( P  < 0.01).,"[{'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Ghaffari', 'Affiliation': 'Health Promotion Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farbod Ebadi Fard', 'Initials': 'FEF', 'LastName': 'Azar', 'Affiliation': 'Health Promotion Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nammam Ali', 'Initials': 'NA', 'LastName': 'Azadi', 'Affiliation': 'Department of Biostatistics, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Mansourian', 'Affiliation': 'Health Management and Economics Research Center, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of education and health promotion,['10.4103/jehp.jehp_537_19']
1943,32793773,Data on advanced glycation end-products concentrations and haemodynamic parameters following caffeine and nicotine consumption in nursing students.,"This work presents data from a non-invasive interventional trial investigating the early effects of caffeine and nicotine on both the concentrations of advanced glycation end-products (AGEs) and haemodynamic parameters in 178 healthy nursing students aged between 18 and 40. These students were allocated into four groups (A, B, C and D) and the concentrations of AGEs as well as haemodynamic parameters were measured non-invasively using the AgeReader and the Finometer devices, respectively. The haemodynamic parameters that were measured included systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, inter-beat interval, stroke volume, cardiac output, ventricular ejection time, total peripheral resistance, ascending aorta impedance and total arterial compliance. According to our protocol, each beverage contained 100 mg of caffeine each cigarette contained 1.5 mg of nicotine. The present data reveal the combined effect of smoke and caffeine consumption to several hemodynamic parameters that may be related to the onset of elevated blood pressure during smoking and following caffeine consumption.",2020,"These students were allocated into four groups (A, B, C and D) and the concentrations of AGEs as well as haemodynamic parameters were measured non-invasively using the AgeReader and the Finometer devices, respectively.","['nursing students', '178 healthy nursing students aged between 18 and 40']","['caffeine and nicotine', 'caffeine and nicotine consumption', 'caffeine each cigarette contained 1.5\u202fmg of nicotine']","['systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate, inter-beat interval, stroke volume, cardiac output, ventricular ejection time, total peripheral resistance, ascending aorta impedance and total arterial compliance']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C2733340', 'cui_str': 'Ventricular ejection'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0003956', 'cui_str': 'Ascending aorta structure'}, {'cui': 'C0162537', 'cui_str': 'Impedance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",178.0,0.0409427,"These students were allocated into four groups (A, B, C and D) and the concentrations of AGEs as well as haemodynamic parameters were measured non-invasively using the AgeReader and the Finometer devices, respectively.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Deltsidou', 'Affiliation': 'Midwifery Department, University of West Attica, Athens, Greece.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Zarikas', 'Affiliation': 'General Department, University of Thessaly, Greece.'}, {'ForeName': 'Dimos', 'Initials': 'D', 'LastName': 'Mastrogiannis', 'Affiliation': 'General Department, University of Thessaly, Lamia, Greece.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Kapreli', 'Affiliation': 'Physiotherapy Department, University of Thessaly, Lamia, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Bourdas', 'Affiliation': 'Second Chance School, Chania, Greece.'}, {'ForeName': 'Vasilios', 'Initials': 'V', 'LastName': 'Raftopoulos', 'Affiliation': 'Hellenic National Public Health Organization, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Noula', 'Affiliation': 'Nursing Department, University of Nicosia, Nicosia, Cyprus.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Lykeridou', 'Affiliation': 'Midwifery Department, University of West Attica, Athens, Greece.'}]",Data in brief,['10.1016/j.dib.2020.106063']
1944,32793789,"Review of SWOG S1314: Lessons from a Randomized Phase II Study of Co-Expression Extrapolation (COXEN) with Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder Cancer.","SWOG1314 is a randomized phase II study of co-expression extrapolation (COXEN) with neoadjuvant chemotherapy for localized, muscle-invasive bladder cancer. COXEN is a biomarker approach in which predictive biomarkers are developed using  in vitro  data, which may then be applied directly into a clinical testing application. Two separate Gene Expression Models (GEMs), one for the Methotrexate, Vinblastine, Doxorubicin, Cisplatin (MVAC) regimen and another for gemcitabine plus cisplatin (GC) were tested in S1314. The lessons learned from the development and operationalization of the S1314 clinical trial are described in detail, which may help to inform the future trials of predictive biomarkers for urothelial carcinoma in the neoadjuvant setting. Specific areas addressed include: The need for broad support from the bladder cancer community, planning for non-evaluable subjects, defining adequate neoadjuvant treatment, defining adequate tissue collection, setting expectations in phase II clinical studies of predictive biomarkers, and maximizing the impact of the samples collected in these studies for broader biomarker development. With a large number of newly available treatments in advanced urothelial carcinoma in the last few years, more investigations of these agents in the neoadjuvant setting is anticipated. There will be a great need for the development of predictive biomarkers in conjunction with the use of these agents in the preoperative setting. Insights from S1314 may provide useful information and lessons learned in this development.",2020,"SWOG1314 is a randomized phase II study of co-expression extrapolation (COXEN) with neoadjuvant chemotherapy for localized, muscle-invasive bladder cancer.","['localized, muscle-invasive bladder cancer']","['Neoadjuvant Chemotherapy', 'Methotrexate, Vinblastine, Doxorubicin, Cisplatin (MVAC) regimen and another for gemcitabine plus cisplatin (GC', 'COXEN', 'neoadjuvant chemotherapy']",[],"[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",[],,0.0288472,"SWOG1314 is a randomized phase II study of co-expression extrapolation (COXEN) with neoadjuvant chemotherapy for localized, muscle-invasive bladder cancer.","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Boxley', 'Affiliation': 'University of Colorado, School of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Plets', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Flaig', 'Affiliation': 'University of Colorado, School of Medicine, University of Colorado, Aurora, CO, USA.'}]","Bladder cancer (Amsterdam, Netherlands)",['10.3233/BLC-190266']
1945,32793846,Interleukin-6 May Not Affect Bone Resorption Marker CTX or Bone Formation Marker P1NP in Humans.,"Context


Interleukin 6 (IL-6) contributes to bone remodeling in preclinical studies. Clinical trials investigating the role of IL-6 in bone remodeling are limited.
Objective


To investigate if IL-6 regulates bone remodeling in humans.
Design


Plasma concentrations of the bone resorption marker carboxy-terminal type I collagen crosslinks (CTX) and of the bone formation marker procollagen type 1 N-terminal propeptide (P1NP) were measured during a mixed-meal tolerance test (MMTT) in 3 placebo-controlled human studies.
Participants


Five healthy individuals participated in study 1; 52 obese individuals, in study 2; and 10 healthy individuals, in study 3.
Interventions


Study 1 was a single-blinded crossover study consisting of a 1-h infusion of saline (placebo) or the IL-6 receptor antibody tocilizumab followed by an exercise bout. Study 2 was a randomized, double-blinded 12-week exercise training intervention study. Participants received infusions of saline or tocilizumab. Study 3 was a randomized, double-blinded, crossover study consisting of 30 min infusion of saline or IL-6.
Main outcomes measures


Effect of IL-6 on CTX levels.
Results


CTX was significantly ( P  < 0.01) decreased during MMTTs in all 3 studies. Treatment with tocilizumab did not affect exercise or meal induced changes in plasma CTX or P1NP concentrations acutely (study 1) or after a 12-week treatment period (study 2). Exogenous IL-6 had no effect on CTX or P1NP plasma concentrations (study 3).
Conclusions


IL-6 may not regulate bone remodeling in humans.",2020,Treatment with tocilizumab did not affect exercise or meal induced changes in plasma CTX or P1NP concentrations acutely (study 1) or after a 12-week treatment period (study 2).,"['Participants\n\n\nFive healthy individuals participated in study 1; 52 obese individuals, in study 2; and 10 healthy individuals, in study 3', 'humans']","['saline or tocilizumab', 'I collagen crosslinks (CTX) and of the bone formation marker procollagen type 1 N-terminal propeptide (P1NP', 'saline (placebo', 'tocilizumab', 'IL-6', 'IL-6 receptor antibody tocilizumab']","['CTX or P1NP plasma concentrations', 'CTX levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0063717', 'cui_str': 'Lymphocyte antigen CD126'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]","[{'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",5.0,0.47895,Treatment with tocilizumab did not affect exercise or meal induced changes in plasma CTX or P1NP concentrations acutely (study 1) or after a 12-week treatment period (study 2).,"[{'ForeName': 'Louise L', 'Initials': 'LL', 'LastName': 'Lehrskov', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Kjeldsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Lyngbæk', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Regitse Højgaard', 'Initials': 'RH', 'LastName': 'Chirstensen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Wedell-Neergaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Søderlund', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Krogh-Madsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",Journal of the Endocrine Society,['10.1210/jendso/bvaa093']
1946,32776202,Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO ® /DYNAGITO ®  Trials.,"INTRODUCTION


Previous studies demonstrated that tiotropium/olodaterol reduced rates of exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this should be examined in a wider population.
METHODS


This post hoc analysis pooled data from TONADO ®  1 + 2 and DYNAGITO ® , three 52-week, parallel-group, randomised, double-blind, phase III trials investigating patients with moderate-to-very severe COPD, with and without previous exacerbations, who received tiotropium/olodaterol 5/5 µg or tiotropium 5 µg. Subgroup analyses were conducted on patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2-4 disease severity and baseline inhaled corticosteroid (ICS) use.
RESULTS


In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus tiotropium. Lower rates of moderate/severe exacerbations with tiotropium/olodaterol versus tiotropium were evident in patients with 0-1 moderate exacerbation in the previous year (0.54 vs. 0.60 per patient-year; RR 0.90, 95% CI 0.82, 0.98; P = 0.0187) and at least two moderate or at least one severe exacerbation(s) in the previous year (0.97 vs. 1.09 per patient-year; RR 0.89, 95% CI 0.82, 0.97; P = 0.0096). In patients with GOLD 2 and GOLD 3 COPD, moderate/severe exacerbation rates were lower with tiotropium/olodaterol versus tiotropium; GOLD 4 patients showed negligible difference between treatments. When evaluating patients by baseline ICS use, there was a significantly lower rate of moderate/severe exacerbations with tiotropium/olodaterol versus tiotropium in patients receiving ICS.
CONCLUSIONS


Tiotropium/olodaterol decreased the rate of moderate/severe exacerbations and exacerbations leading to hospitalisation versus tiotropium. Results from this large, pooled, post hoc analysis support the use of dual bronchodilation with tiotropium/olodaterol in a broad range of patients, reflective of patients with COPD in clinical practice.
TRIAL REGISTRATION


TONADO ®  1 (ClinicalTrials.gov: NCT01431274); TONADO ®  2 (ClinicalTrials.gov: NCT01431287); DYNAGITO ®  (ClinicalTrials.gov: NCT02296138). People with chronic obstructive pulmonary disease (COPD) may have times when their symptoms worsen, known as exacerbations. This may mean that they need to take additional medications, such as antibiotics or oral steroids. Studies have shown that a combination of two types of inhaled medicine-tiotropium and olodaterol-can help to reduce exacerbations in some people. To see if this is also the case across a larger and more diverse range of people, we combined the results from three studies (TONADO ®  1 + 2 and DYNAGITO ® ) that looked at people who were taking tiotropium and olodaterol together and people who were taking tiotropium alone. We showed that, across a wide range of people, treatment with tiotropium/olodaterol was generally better at reducing exacerbations than tiotropium. Tiotropium/olodaterol also decreased the number of exacerbations that led to hospitalisation compared with tiotropium. Overall, our results support the use of combined tiotropium/olodaterol in people at different stages of COPD.",2020,"In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus tiotropium.","['patients with moderate-to-very severe COPD, with and without previous exacerbations, who received', 'patients stratified by exacerbation history, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 2-4 disease severity and baseline inhaled corticosteroid (ICS) use', 'patients with chronic obstructive pulmonary disease (COPD', 'Patients with COPD', 'People with chronic obstructive pulmonary disease (COPD']","['tiotropium/olodaterol versus tiotropium; GOLD', 'tiotropium/olodaterol 5/5\xa0µg or tiotropium 5\xa0µg', 'Tiotropium/Olodaterol', 'tiotropium/olodaterol', 'Tiotropium/olodaterol', 'inhaled medicine-tiotropium', 'tiotropium/olodaterol versus tiotropium', 'Tiotropium', 'tiotropium']","['number of exacerbations', 'severe exacerbation rates', 'rate of moderate/severe exacerbations', 'Lower rates of moderate/severe exacerbations', 'Exacerbation Rates', 'exacerbations requiring hospitalisation', 'rates of moderate/severe exacerbations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0213771', 'cui_str': 'tiotropium'}, {'cui': 'C2934193', 'cui_str': 'olodaterol'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",9942.0,0.709479,"In 9942 patients, tiotropium/olodaterol was associated with lower rates of moderate/severe exacerbations (0.68 vs. 0.77 per patient-year; rate ratio (RR) vs. tiotropium 0.89, 95% confidence interval (CI) 0.84, 0.95; P = 0.0003) and exacerbations requiring hospitalisation (0.11 vs. 0.13 per patient-year; RR 0.86, 95% CI 0.75, 0.99; P = 0.0380) versus tiotropium.","[{'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'Respiratory Division, National Heart and Lung Institute, Imperial College London, London, UK. j.wedzicha@imperial.ac.uk.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Buhl', 'Affiliation': 'Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps University of Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'de la Hoz', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Wenqiong', 'Initials': 'W', 'LastName': 'Xue', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Anzueto', 'Affiliation': 'Department of Pulmonary Medicine and Critical Care, University of Texas Health Sciences Center and South Texas Veterans Health Care System, San Antonio, TX, USA.'}, {'ForeName': 'Peter M A', 'Initials': 'PMA', 'LastName': 'Calverley', 'Affiliation': 'Clinical Science Centre, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}]",Advances in therapy,['10.1007/s12325-020-01438-3']
1947,32776933,"High endemicity of Clonorchis sinensis infection in Binyang County, southern China.","High-intensity clonorchiasis infection is associated with serious outcomes, including cancer. Understanding the infection intensity of Clonorchis sinensis and its risk factors in local endemic regions could facilitate effective control measures. In a county located in a highly endemic area in Guangxi Province, P. R. China, local residents were randomly enrolled in the study; helminth egg examinations were performed with the Kato-Katz method, and the intensity of infection was identified as mild, moderate or heavy. Knowledge, attitudes, and high-risk behaviours were investigated among those infected with Clonorchis sinensis. A total of 2521 local residents participated in this study, and the Clonorchis sinensis-positive proportion was 28.9% (728 persons). Among the infected persons, the percentages of mild, moderate and heavy infections were 66.2%, 28.4% and 5.4%, respectively. Males experienced a higher proportion of moderate and heavy infections (37.5%) than females (18.1%) (p<0.05). The highest infection proportion among the different levels of infection intensity was identified among persons aged 30-59 years (15.7% for moderate and heavy infections). Among the 509 persons who reported eating raw fish, 302 persons (59.3%) had eaten raw fresh fish for more than 10 years, and 131 (25.7%) persons ate raw fish ≥12 times a year. Multivariate logistic regression revealed that eating raw fish 12-50 times in the last year (adjusted odds ratio [aOR] = 1.74, 95%CI: 1.09-2.80) and eating raw fish >50 times in the last year (aOR = 2.89, 95%CI: 1.20-7.50) were risk factors for high-intensity infections (moderate and heavy). The overall infection proportion was high in the study area, with a large group of residents experiencing high-intensity infections. High frequency of raw fish consumption was associated with high-intensity infections. Intervention strategies targeting people with a high frequency of raw fish consumption should be implemented to reduce the probability of severe consequences.",2020,"Among the 509 persons who reported eating raw fish, 302 persons (59.3%) had eaten raw fresh fish for more than 10 years, and 131 (25.7%) persons ate raw fish ≥12 times a year.","['High endemicity of Clonorchis sinensis infection in Binyang County, southern China', '2521 local residents participated in this study, and the Clonorchis sinensis-positive proportion was 28.9% (728 persons', 'In a county located in a highly endemic area in Guangxi Province, P. R. China, local residents were randomly enrolled in the study; helminth egg examinations', '509 persons who reported eating raw fish, 302 persons (59.3%) had eaten raw fresh fish for more than 10 years, and 131 (25.7%) persons ate raw fish ≥12 times a year']",[],"['infection intensity', 'Knowledge, attitudes, and high-risk behaviours', 'percentages of mild, moderate and heavy infections', 'High frequency of raw fish consumption', 'overall infection proportion', 'moderate and heavy infections']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009021', 'cui_str': 'Clonorchiasis'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009022', 'cui_str': 'Clonorchis sinensis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018893', 'cui_str': 'Helminth'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",[],"[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",2521.0,0.0339929,"Among the 509 persons who reported eating raw fish, 302 persons (59.3%) had eaten raw fresh fish for more than 10 years, and 131 (25.7%) persons ate raw fish ≥12 times a year.","[{'ForeName': 'Junling', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Division of Infectious Disease, Key Laboratory of Surveillance and Early Warning on Infectious Disease, Chinese Centre for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Hualei', 'Initials': 'H', 'LastName': 'Xin', 'Affiliation': 'Division of Infectious Disease, Key Laboratory of Surveillance and Early Warning on Infectious Disease, Chinese Centre for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': 'Guangxi Centre for Disease Control and Prevention, Nanning, China.'}, {'ForeName': 'Menbao', 'Initials': 'M', 'LastName': 'Qian', 'Affiliation': 'National Institute of Parasitic Diseases, Chinese Centre for Disease Control and Prevention; WHO Collaborative Centre for Malaria, Schistosomiasis and Filariasis; Key Laboratory of Parasite and Vector Biology, Ministry of Health, Shanghai, China.'}, {'ForeName': 'Kaixia', 'Initials': 'K', 'LastName': 'Duan', 'Affiliation': 'Malaria Control Department, Yunnan Institute of Parasitic Diseases, Yunnan, China.'}, {'ForeName': 'Yingdan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'National Institute of Parasitic Diseases, Chinese Centre for Disease Control and Prevention; WHO Collaborative Centre for Malaria, Schistosomiasis and Filariasis; Key Laboratory of Parasite and Vector Biology, Ministry of Health, Shanghai, China.'}, {'ForeName': 'Shizhu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'National Institute of Parasitic Diseases, Chinese Centre for Disease Control and Prevention; WHO Collaborative Centre for Malaria, Schistosomiasis and Filariasis; Key Laboratory of Parasite and Vector Biology, Ministry of Health, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Parasite Disease Control Department, Binyang Centre for Disease Control and Prevention, Nanning, China.'}, {'ForeName': 'Shiyong', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Director, Binyang Centre for Disease Control and Prevention, Nanning, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Gan', 'Affiliation': 'Deputy Director, Binyang Centre for Disease Control and Prevention, Nanning, China.'}, {'ForeName': 'Yichao', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Guangxi Centre for Disease Control and Prevention, Nanning, China.'}, {'ForeName': 'Zhongjie', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Division of Infectious Disease, Key Laboratory of Surveillance and Early Warning on Infectious Disease, Chinese Centre for Disease Control and Prevention, Beijing, China.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008540']
1948,32777456,The effect of disclosing life expectancy information on patients' prognostic understanding: secondary outcomes from a multicenter randomized trial of a palliative chemotherapy educational intervention.,"CONTEXT


Many advanced cancer patients have unrealistic prognostic expectations.
OBJECTIVES


We tested whether offering life expectancy (LE) statistics within palliative chemotherapy (PC) education promotes realistic expectations.
METHODS


In this multicenter trial, patients with advanced colorectal and pancreatic cancers initiating first or second line PC were randomized to usual care versus a PC educational tool with optional LE information. Surveys at 2 weeks and 3 months assessed patients' review of the LE module and their reactions; at 3 months, patients estimated their LE and reported occurrence of prognosis and end-of-life (EOL) discussions. Wilcoxon tests and proportional odds models evaluated between-arm differences in LE self-estimates, and how realistic those estimates were (based on cancer type and line of treatment).
RESULTS


From 2015-2017, 92 patients were randomized to the intervention and 94 to usual care. At baseline most patients (80.9%) wanted ""a lot"" or ""as much information as possible"" about the impact of chemotherapy on LE. Among patients randomized to the intervention, 52.0% reviewed the LE module by 2 weeks and 66.7% by 3 months - of whom 88.2% reported the information was important, 31.4% reported it was upsetting, and 3.9% regretted reviewing it. Overall, patients' LE self-estimates were very optimistic; 71.4% of colorectal cancer patients estimated >5yrs; 50% pancreatic patients estimated >2yrs. The intervention had no effect on the length or realism of patients' LE self-estimates, or on the occurrence of prognostic or EOL discussions.
CONCLUSIONS


Offering LE information within a PC educational intervention had no effect on patients' prognostic expectations.",2020,"The intervention had no effect on the length or realism of patients' LE self-estimates, or on the occurrence of prognostic or EOL discussions.
","['patients with advanced colorectal and pancreatic cancers initiating first or second line PC', ""patients' prognostic understanding"", 'From 2015-2017', 'advanced cancer patients', '92 patients']","['palliative chemotherapy educational intervention', 'palliative chemotherapy (PC) education', 'usual care versus a PC educational tool with optional LE information']","[""length or realism of patients' LE self-estimates, or on the occurrence of prognostic or EOL discussions"", 'occurrence of prognosis and end-of-life (EOL) discussions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}]",92.0,0.088382,"The intervention had no effect on the length or realism of patients' LE self-estimates, or on the occurrence of prognostic or EOL discussions.
","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Enzinger', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, MA; Division of Gastrointestinal Oncology, Dana-Farber/Partners CancerCare, Boston, MA. Electronic address: andrea_enzinger@dfci.harvard.edu.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Uno', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'McCleary', 'Affiliation': 'Division of Gastrointestinal Oncology, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Frank', 'Affiliation': ""Susan F. Smith Center for Women's Cancers, Dana-Farber/Partners CancerCare, Boston, MA.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Sanoff', 'Affiliation': 'Division of Medical Oncology, University of North Carolina Lineberger Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Van Loon', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Khalid', 'Initials': 'K', 'LastName': 'Matin', 'Affiliation': 'Division of Medical Oncology, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bullock', 'Affiliation': 'Division of Medical Oncology, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Cronin', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Bagley', 'Affiliation': 'Department of Nursing, Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Schrag', 'Affiliation': 'Division of Population Sciences, Dana-Farber/Partners CancerCare, Boston, MA; Division of Gastrointestinal Oncology, Dana-Farber/Partners CancerCare, Boston, MA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.07.025']
1949,32777710,Community-level interventions for pre-eclampsia (CLIP) in Pakistan: A cluster randomised controlled trial.,"OBJECTIVES


To reduce all-cause maternal and perinatal mortality and major morbidity through Lady Health Worker (LHW)-facilitated community engagement and early diagnosis, stabilization and referral of women with preeclampsia, an important contributor to adverse maternal and perinatal outcomes given delays in early detection and initial management.
STUDY DESIGN


In the Pakistan Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomized controlled trial (NCT01911494), LHWs engaged the community, recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization.
MAIN OUTCOME MEASURES


The primary outcome was a composite of maternal, fetal and newborn mortality and major morbidity.
FINDINGS


We recruited 39,446 women in intervention (N = 20,264) and control clusters (N = 19,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively). The primary outcome did not differ between intervention (26·6%) and control (21·9%) clusters (adjusted odds ratio, aOR, 1∙20 [95% confidence interval 0∙84-1∙72]; p = 0∙31). There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77); early (0·95 [0·82-1·09]; p = 0·46) or late neonatal deaths (1·23 [0·97-1·55]; p = 0·09); or neonatal morbidity (1·22 [0·77, 1·96]; p = 0·40). Improvements in outcome rates were observed with 4-7 (p = 0·015) and ≥8 (p < 0·001) (vs. 0) CLIP contacts.
INTERPRETATION


The CLIP intervention was well accepted by the community and implemented by LHWs. Lack of effects on adverse outcomes could relate to quality care for mothers with pre-eclampsia in health facilities. Future strategies for community outreach must also be accompanied by health facility strengthening.
FUNDING


The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","['39,446 women in intervention (N\xa0=\xa020,264) and control clusters (N\xa0=\xa019,182) with minimal loss to follow-up (3∙7% vs. 4∙5%, respectively', 'mothers with pre-eclampsia in health facilities', 'recruited pregnant women from 20 union councils (clusters), undertook mobile health-guided clinical assessment for preeclampsia, and referral to facilities after stabilization', 'pre-eclampsia (CLIP) in Pakistan', 'women with preeclampsia']","['Community-level interventions', 'CLIP intervention']","['late neonatal deaths', 'neonatal morbidity', 'outcome rates', 'maternal death', 'reduction in stillbirths', 'composite of maternal, fetal and newborn mortality and major morbidity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}]","[{'cui': 'C0455987', 'cui_str': 'Late neonatal death'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",39446.0,0.261501,"There was reduction in stillbirths (0·89 [0·81-0·99]; p = 0·03), but no impact on maternal death (1·08 [0·69, 1·71]; p = 0·74) or morbidity (1·12 [0·57, 2·16]; p = 0·77);","[{'ForeName': 'Rahat N', 'Initials': 'RN', 'LastName': 'Qureshi', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Hoodbhoy', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305-4088 Cambie Street, Vancouver, BC V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver, BC V6Z 1Y6, Canada.""}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Palace Road, London SE1 7EH, UK.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre of Excellence, Division of Woman and Child Health, Aga Khan University, Stadium Road, P. O. Box 3500, Karachi 74800, Pakistan; Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto, ON M5G 2L3, Canada. Electronic address: zulfiqar.bhutta@aku.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'the CLIP Pakistan Trial Working Group (Table S1).'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.07.011']
1950,32777737,Evaluation of efficacy and safety of rituximab in combination with mycophenolate mofetil in patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD): A double-blind placebo-controlled randomized trial.,"INTRODUCTION


Nonspecific interstitial pneumonia (NSIP) are rare but severe diseases, with high mortality and morbidity, with no effective pharmacological treatment allowing for long-term remission, and therefore no clear therapeutic recommendations. Classic immunosuppressants are used as first-line treatment, with only one third of patients being responders and no clear recommendations exist for the choice of the second-line therapy. The EvER-ILD study is the first one to prospectively evaluate the efficacy and safety of rituximab and mycophenolate mofetil (MMF) versus placebo and MMF in a broad range of NSIP patients that did not respond to a first-line therapy. A pharmacokinetic-pharmacodynamic analysis based on rituximab serum concentrations will allow identification of potential factors associated with therapeutic response and/or adverse effects.
METHODS


EvER-ILD study is a French multicenter, prospective, randomized, double blind, placebo-controlled, superiority trial. Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment will be randomized in 2 groups of treatment: one course of rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group). The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months. Several clinical, biological, and quality of life secondary outcomes will be measured at 3, 6 and 12 months. A sample size of 122 patients (61 patients per group) would allow to show a point difference between groups in the change of FVC at 6 months, based on a common standard deviation for FVC change of 8% with a power of 90%, alpha 5% two-sided, and anticipating an extreme 10% drop-out rate.
ETHICS AND DISSEMINATION


The protocol was approved by the French Research Ethics Committee (CPP Tours Ouest 1 2016-R28) on November 10, 2016, and by the French competent authority (ANSM, reference 160771A-22) on December 1st, 2016. This article refers to protocol V2, dated November 18, 2016. An independent data safety monitoring board will review safety and tolerability data for the duration of the trial. Results will be disseminated via peer reviewed publication and presentation at international conferences.
TRIAL REGISTRATION NUMBER


NCT02990286 (clinicaltrials.gov), EudraCT 2016-003026-16 (European Medicines agency).",2020,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","['2016-003026-16 (European Medicines agency', '122 patients (61 patients per group', 'patients with nonspecific interstitial pneumonia non-responding to a first-line immunosuppressive treatment (EVER-ILD', 'Patients with severe and progressive NSIP non-responding to a first line immunosuppressive treatment']","['EudraCT', 'mycophenolate mofetil', 'rituximab and mycophenolate mofetil (MMF) versus placebo and MMF', 'rituximab plus 6 months MMF (RTX-MMF group) and one course of placebo plus 6 months MMF (Placebo-MMF group', 'rituximab', 'placebo']","['change in Forced Vital Capacity (FVC, % of predicted']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1290344', 'cui_str': 'Nonspecific interstitial pneumonia'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0073081', 'cui_str': 'resiniferatoxin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}]",,0.378227,"The primary outcome is the change in Forced Vital Capacity (FVC, % of predicted) from baseline to 6 months.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bejan-Angoulvant', 'Affiliation': 'Service de Pharmacologie médicale, CHRU de Tours, Hôpital Bretonneau, Université de Tours, Tours, France.'}, {'ForeName': 'J-Marc', 'Initials': 'JM', 'LastName': 'Naccache', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Caille', 'Affiliation': 'Inserm CIC1415, CHRU Tours, Université de Tours, Université de Nantes, SPHERE, U1246, Tours, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Borie', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Nunes', 'Affiliation': 'Service de pneumologie, centre constitutif pour les maladies pulmonaires rares, hôpital Avicenne, CHU Paris Seine-Saint-Denis, Bobigny, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ferreira', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cadranel', 'Affiliation': 'AP-HP, Hôpital Tenon, service de pneumologie, Site constitutif du centre de référence pour les maladies pulmonaires rares OrphaLung, and Sorbonne Université, Paris, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Crestani', 'Affiliation': 'AP-HP, service de pneumologie, centre de compétences pour les maladies pulmonaires rares, Hôpital Bichat, Paris, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'Service de Pneumologie, Centre national coordonnateur de référence des maladies pulmonaires rares, Hôpital Louis Pradel, Hospices civils de Lyon, UMR 754, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Marchand-Adam', 'Affiliation': 'Service de Pneumologie, CHRU de Tours, Centre de compétences des maladies pulmonaires rares de la région Centre, Hôpital Bretonneau, Tours, France; Université de Tours, CEPR Inserm U1100, Tours, France. Electronic address: s.marchandadam@univ-tours.fr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Respiratory medicine and research,['10.1016/j.resmer.2020.100770']
1951,32778434,Multi-cultural perspectives on group singing among diverse older adults.,"Group choir singing has been shown to have health benefits for older adults. However, because most studies have included predominantly white participants, it is unknown whether findings generalize to older adults from more diverse backgrounds. This multi-site qualitative study assessed perceived benefits of group singing for socioeconomically and racially/ethnically diverse older adults. We interviewed 31 choir participants, 6 music professionals and 6 administrators involved in a large, cluster-randomized trial. We used content analysis to identify themes. Psychosocial engagement was most commonly reported, with six components: emotional well-being, self-esteem, self-confidence, social connection and support, decreased loneliness, and cultural identity and multi-cultural appreciation. A few reported cognitive and physical benefits. They also suggest that group singing among ethnically diverse older adults can have multiple psychosocial benefits and enhance a sense of cultural identity and appreciation of other cultures. These findings can help in selecting structured outcome measures for choir interventions.",2020,"Psychosocial engagement was most commonly reported, with six components: emotional well-being, self-esteem, self-confidence, social connection and support, decreased loneliness, and cultural identity and multi-cultural appreciation.","['older adults', 'diverse older adults', '31 choir participants, 6 music professionals and 6 administrators involved in a large, cluster-randomized trial', 'ethnically diverse older adults', 'socioeconomically and racially/ethnically diverse older adults']",[],"['emotional well-being, self-esteem, self-confidence, social connection and support, decreased loneliness, and cultural identity and multi-cultural appreciation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0085751', 'cui_str': 'Administrators'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]",31.0,0.0463533,"Psychosocial engagement was most commonly reported, with six components: emotional well-being, self-esteem, self-confidence, social connection and support, decreased loneliness, and cultural identity and multi-cultural appreciation.","[{'ForeName': 'Theresa A', 'Initials': 'TA', 'LastName': 'Allison', 'Affiliation': 'Division of Geriatrics, Department of Medicine and Department of Family & Community Medicine, University of California, 4150 Clement Street, Box 181-G, San Francisco, CA 94121, United States. Electronic address: theresa.allison@ucsf.edu.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Nápoles', 'Affiliation': 'Division of Intramural Research, National Institute on Minority Health and Health Disparities, National Institutes of Health, 9000 Rockville Pike, Building 3, Floor 5, Room E08, Bethesda, MD 20892, United States.'}, {'ForeName': 'Julene K', 'Initials': 'JK', 'LastName': 'Johnson', 'Affiliation': 'Institute for Health & Aging, School of Nursing, University of California San Francisco, 3333 California Street, Suite 340, San Francisco, CA 94118, United States.'}, {'ForeName': 'Anita L', 'Initials': 'AL', 'LastName': 'Stewart', 'Affiliation': 'Institute for Health & Aging, School of Nursing, University of California San Francisco, 3333 California Street, Suite 340, San Francisco, CA 94118, United States.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Rodriguez-Salazar', 'Affiliation': 'San Francisco Community Music Center, 544 Capp Street, San Francisco, CA 94110, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Peringer', 'Affiliation': 'San Francisco Community Music Center, 544 Capp Street, San Francisco, CA 94110, United States.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Sherman', 'Affiliation': 'San Francisco Community Music Center, 544 Capp Street, San Francisco, CA 94110, United States.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ortez-Alfaro', 'Affiliation': 'Institute for Health & Aging, School of Nursing, University of California San Francisco, 3333 California Street, Suite 340, San Francisco, CA 94118, United States.'}, {'ForeName': 'Ofelia', 'Initials': 'O', 'LastName': 'Villero', 'Affiliation': 'Institute for Health & Aging, School of Nursing, University of California San Francisco, 3333 California Street, Suite 340, San Francisco, CA 94118, United States.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Portacolone', 'Affiliation': 'Institute for Health & Aging, School of Nursing, University of California San Francisco, 3333 California Street, Suite 340, San Francisco, CA 94118, United States.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.07.011']
1952,32773150,When will I feel normal again? Trajectories and predictors of persistent symptoms and poor wellbeing after primary chemotherapy for ovarian cancer.,"OBJECTIVES


After treatment for ovarian cancer, women want to know when they will feel 'normal' again. Our objective was to document the proportions of women with high levels of physical and emotional symptoms at the end of treatment, determine if/when they return to normal and identify groups at risk of persistent symptoms/delayed recovery.
METHODS


Women in the OPAL (Ovarian cancer Prognosis And Lifestyle) study who received ≥3 cycles of first-line chemotherapy and completed patient-reported outcome (PRO) questionnaires on or < 6 weeks after completing chemotherapy (baseline) were included in this analysis (n = 527). PRO measures included anxiety, depression, insomnia, fatigue and wellbeing (quality-of-life) at baseline, 3, 6, 9 and 18 months post-baseline. Group-based trajectory models identified clusters of individuals who followed similar patterns. Logistic and Cox regression identified factors associated with persistent symptoms and delayed recovery, respectively.
RESULTS


At baseline, 57% of women reported moderate-to-severe fatigue, 22% anxiety, 20% depression, 14% clinical insomnia and 45% had quality-of-life scores significantly lower than the general population. Between 50 and 75% of individual PRO scores normalised within six months, with the exception of emotional wellbeing (42%), but approximately two-in-five women still had at least one persistently poor PRO at 18 months. Women with more severe symptoms at baseline, who were younger, or had a history of anxiety/depression were more likely to have persistent symptoms or delayed recovery.
CONCLUSIONS


Two-in-five women might never fully return to 'normal' after completing primary treatment for ovarian cancer. Those with risk factors should be triaged for early supportive interventions.",2020,"PRO measures included anxiety, depression, insomnia, fatigue and wellbeing (quality-of-life) at baseline, 3, 6, 9 and 18 months post-baseline.","['ovarian cancer', 'Women in the OPAL (Ovarian cancer Prognosis And Lifestyle) study who received ≥3\u202fcycles of first-line chemotherapy and completed patient-reported outcome (PRO) questionnaires on or\u202f<\u202f6\u202fweeks after completing chemotherapy (baseline) were included in this analysis (n\u202f=\u202f527']",[],"['emotional wellbeing', 'moderate-to-severe fatigue', 'anxiety, depression, insomnia, fatigue and wellbeing (quality-of-life', 'quality-of-life scores', 'individual PRO scores']","[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0084990', 'cui_str': 'VPDA protocol'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4517805', 'cui_str': '527'}]",[],"[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",,0.157661,"PRO measures included anxiety, depression, insomnia, fatigue and wellbeing (quality-of-life) at baseline, 3, 6, 9 and 18 months post-baseline.","[{'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Beesley', 'Affiliation': 'Gynaecological Cancers Group, QIMR Berghofer Medical Research Institute, Brisbane, Australia. Electronic address: Vanessa.Beesley@qimrberghofer.edu.au.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Webber', 'Affiliation': 'Department of Medical Oncology, Prince of Wales Hospital, Sydney, Australia; Prince of Wales Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Nagle', 'Affiliation': 'Gynaecological Cancers Group, QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'DeFazio', 'Affiliation': 'The Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia; Department of Gynaecological Oncology, Westmead Hospital, Sydney, Australia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Obermair', 'Affiliation': ""Queensland Centre for Gynaecological Cancer, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Merran', 'Initials': 'M', 'LastName': 'Williams', 'Affiliation': 'No affiliation. Consumer representative.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Department of Medical Oncology, Prince of Wales Hospital, Sydney, Australia.'}, {'ForeName': 'Penelope M', 'Initials': 'PM', 'LastName': 'Webb', 'Affiliation': 'Gynaecological Cancers Group, QIMR Berghofer Medical Research Institute, Brisbane, Australia; School of Public Health, The University of Queensland, Brisbane, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gynecologic oncology,['10.1016/j.ygyno.2020.07.029']
1953,32781283,Efficacy of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in treatment of COVID-19: A randomized controlled trial.,"BACKGROUND


With the global epidemic of coronavirus disease (COVID-19), China has made progress in the prevention and control of the epidemic, and traditional Chinese medicine (TCM) has played a key role in dealing with the disease's effects on the respiratory system. This randomized controlled clinical trial evaluated the clinical efficacy and prognosis of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules in patients with COVID-19.
METHODS


A total of 283 patients participated in this clinical trial, and participants were randomly assigned to receive either 1) Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules or 2) Linahua granules, both combined with western medicine, or 3) western medicine alone for 14 days. At the end of the trial, the improvement and resolution rates of clinical symptoms and the rate of patients who progressed to severe disease status were evaluated.
RESULTS


After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05). Huoxiang Zhengqi dropping pills combined with Lianhua Qingwen granules has advantages in the treatment of nausea, vomiting and limb soreness. During treatment, all participants were treated with western medicine, and there was a significant difference in the use of macrolides among the three groups (P < 0.05). Specifically, the utilization rate of antibiotics in the western medicine group was significantly greater than that of the other two groups. Among the 182 diagnosed patients who completed this clinical trial, 13 patients progressed to severe disease, including one case in the Huoxiang + Lianhua group (1.6%), five cases in the Lianhua group (8.6%), and seven cases in the western medicine group (11.1%). There was no statistical differences in this rate among the three groups (P >  0.05). However, the proportion of patients who progressed to severe disease in the Huoxiang + Lianhua group was the lowest, suggesting that the combination of TCM with western medicine has a potential advantage in improving the prognosis of patients with COVID-19.
CONCLUSION


The use of Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine may have clinical advantages for COVID-19 patients in improving clinical symptoms, reducing utilization rate of anti-infective drugs, and improving patient prognosis, which could pave the way for the use of complementary medicine in treating this infection.",2020,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","['patients with COVID-19', 'COVID-19', '283 patients participated in this clinical trial, and participants', '182 diagnosed patients']","['Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules', 'Huoxiang Zhengqi dropping pills and Lianhua Qingwen granules combined with western medicine']","['utilization rate of antibiotics', 'improvement rate of clinical symptoms', 'nausea, vomiting and limb soreness', 'severe disease']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C1871293', 'cui_str': 'Huoxiang-zhengqi'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",283.0,0.0509695,"After 14 days of treatment, there was no significant difference in the improvement rate of clinical symptoms among the three groups (P > 0.05).","[{'ForeName': 'Mingzhong', 'Initials': 'M', 'LastName': 'Xiao', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: xmz0001@sohu.com.'}, {'ForeName': 'Jiaxing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China. Electronic address: tina_yai@126.com.'}, {'ForeName': 'Yana', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: nana680@sina.com.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 510247444@qq.com.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Min', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Mxj922@sohu.com.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lv', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 562163610@qq.com.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 719834165@qq.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, 10029, China. Electronic address: novelzhang@sina.com.'}, {'ForeName': 'Dengying', 'Initials': 'D', 'LastName': 'Yan', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: yandengying@outlook.com.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Lang', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: suping.lang@gcp-clinplus.com.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: r.e.x@163.com.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Fan', 'Affiliation': 'GCP ClinPlus Co., Ltd., Beijing, 100160, China. Electronic address: an.fan@gcp-clinplus.com.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Ke', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 24929135@qq.com.'}, {'ForeName': 'Xiuyang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: leexiuyang@126.com.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 291560898@qq.com.'}, {'ForeName': 'Manhong', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 43166472@qq.com.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 48302079@qq.com.'}, {'ForeName': 'Jinyue', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 627525649@qq.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 491193488@qq.com.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 87068066@qq.com.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zeng', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 309452513@qq.com.'}, {'ForeName': 'Chengyin', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: 40691534@qq.com.'}, {'ForeName': 'Yujiao', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: luoyuorz@163.com.""}, {'ForeName': 'Haoran', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: dr-whr@foxmail.com.""}, {'ForeName': 'Jiaran', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: 502230253@qq.com.""}, {'ForeName': 'Fengmei', 'Initials': 'F', 'LastName': 'Lian', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: lfm565@sohu.com.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Hubei University of Chinese Medicine, Wuhan, 430061, China; Hubei Provincial Hispital of Traditional Chinese Medicine, Wuhan, 430061, China; Hubei Province Academy of Traditional Chinese Medicine, Wuhan, 430074, China. Electronic address: Lixiaodong555@126.com.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Tong', 'Affiliation': ""Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. Electronic address: tongxiaolin@vip.163.com.""}]",Pharmacological research,['10.1016/j.phrs.2020.105126']
1954,32781360,"Intrauterine administration of autologous hCG- activated peripheral blood mononuclear cells improves pregnancy outcomes in patients with recurrent implantation failure; A double-blind, randomized control trial study.","We aimed to investigate the effect of intrauterine administration of autologous hCG-activated PBMCs in RIF women with low Th-17/Treg cell ratio. 248 women with a history of implantation failure volunteered to receive PBMC-therapy. After immunologic consultation and doing flow cytometry analysis, 100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control were enrolled in this study. These 100 patients were randomly divided into two groups as PBMC receiving (n = 50) and controls (n = 50). Then PBMCs were obtained from patients and treated with hCG for 48 h. Afterward, PBMCs were administered into the uterine cavity of the patient in the study group, two days before ET. The concentration of inflammatory cytokines was examined in the supernatant of cultured PBMCs after 2, 24, and 48 h of incubation using the ELISA method. The frequency of Th-17, Treg, and the Th-17/Treg ratio was significantly lower in RIF women than the healthy controls (P < 0.0001). The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001). The pregnancy and live birth rate were significantly increased in women undergoing the PBMC-therapy compared to control (PBS-injecting) group (P = 0.032 and P = 0.047, respectively). The miscarriage rate was considerably lower in PBMC-therapy group (P = 0.029). Our findings suggest that intrauterine administration of autologous in vitro hCG-activated PBMCs improves pregnancy outcomes in patients with at least three IVF/ET failures.",2020,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"['100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control', 'patients with recurrent implantation failure', '100 patients', 'RIF women with low Th-17/Treg cell ratio', '248 women with a history of implantation failure volunteered to receive']","['hCG', 'autologous hCG-activated PBMCs', 'autologous hCG- activated peripheral blood mononuclear cells', 'PBMC-therapy']","['concentration of inflammatory cytokines', 'pregnancy and live birth rate', 'pregnancy outcomes', 'miscarriage rate', 'secretion of inflammatory cytokines', 'frequency of Th-17, Treg, and the Th-17/Treg ratio']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",248.0,0.138794,The secretion of inflammatory cytokines was significantly higher after 48 h compared to 2 and 24 h (P < 0.0001).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Pourmoghadam', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Soltani-Zangbar', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golshan', 'Initials': 'G', 'LastName': 'Sheikhansari', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Ramyar', 'Initials': 'R', 'LastName': 'Azizi', 'Affiliation': 'Drug Applied Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Eghbal-Fard', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Non-Communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Homayoon', 'Initials': 'H', 'LastName': 'Siahmansouri', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Leili', 'Initials': 'L', 'LastName': 'Aghebati-Maleki', 'Affiliation': 'Immunology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Danaii', 'Affiliation': 'Gynecology Department, Eastern Azerbaijan ACECR ART center, Eastern Azerbaijan branch of ACECR, Tabriz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mehdizadeh', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Hojjat-Farsangi', 'Affiliation': 'Department of Oncology-Pathology, Immune and Gene Therapy Lab, Cancer Center Karolinska (CCK), Karolinska University Hospital Solna and Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Motavalli', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Kidney Disease Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: Yousefime@tbzmed.ac.ir.'}]",Journal of reproductive immunology,['10.1016/j.jri.2020.103182']
1955,32781371,A pragmatic randomised controlled trial of the fostering changes programme.,"BACKGROUND


Many looked after young people in Wales are cared for by foster or kinship carers, usually as a consequence of maltreatment or developmentally traumatising experiences within a family context. Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care.
OBJECTIVE


To determine whether group-based training improves foster carer self-efficacy.
PARTICIPANTS AND SETTING


Participants are foster carers, currently looking after children aged 2+ years for at least 12 weeks. Carers from households where one or more carer had previously attended the training were not eligible. Sixteen local authorities and three independent fostering providers in Wales took part.
METHODS


The primary outcome measure was the Carer Efficacy Questionnaire assessed at 12 months. Secondary outcomes included the Strengths and Difficulties Questionnaire, Quality of Attachment Questionnaire, Carer Defined Problems Scale, Carer Coping Strategies, placement moves.
RESULTS


312 consented foster carers were allocated to FC (n = 204) or usual care (n = 108) group. 65.3 % of FC group participants attended sufficient training sessions (8/12, including sessions three and four). There were no differences in carer-reported self-efficacy at 12 months (adjusted difference in means (95 % CI): -0.19 (-1.38 to 1.00)). Small differences in carer-reported child behaviour difficulties and carer coping strategies over time favoured the intervention but these effects diminished from three to 12 months. No other intervention effects were observed.
CONCLUSIONS


Although well-received by participants, training was associated with small and mostly short-term benefit for trial secondary outcomes.",2020,"Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care.
","['Participants are foster carers, currently looking after children aged 2+ years for at least 12 weeks', 'Sixteen local authorities and three independent fostering providers in Wales took part', '312 consented foster carers']","['usual care', 'FC']","['foster carer self-efficacy', 'carer-reported self-efficacy', 'Strengths and Difficulties Questionnaire, Quality of Attachment Questionnaire, Carer Defined Problems Scale, Carer Coping Strategies, placement moves', 'Carer Efficacy Questionnaire']","[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]",[],"[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",312.0,0.166724,"Confidence in Care is a pragmatic unblinded individually randomised controlled parallel group trial evaluating a training programme to improve foster carer self-efficacy, when compared to usual care.
","[{'ForeName': 'Gwenllian', 'Initials': 'G', 'LastName': 'Moody', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: MoodyG@cardiff.ac.uk.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Coulman', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: JohnE1@cardiff.ac.uk.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Brookes-Howell', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: Brookes-HowellLC@cardiff.ac.uk.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cannings-John', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: CanningsRL@cardiff.ac.uk.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Channon', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: ChannonS2@cardiff.ac.uk.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales. Electronic address: LauTM@cardiff.ac.uk.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Rees', 'Affiliation': ""Children's Social Care Research and Development Centre (CASCADE), School of Social Sciences, Cardiff University, United Kingdom, Wales. Electronic address: ReesA1@cardiff.ac.uk.""}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Segrott', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom, Wales. Electronic address: SegrottJ@cardiff.ac.uk.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Scourfield', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom, Wales. Electronic address: Scourfield@cardiff.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research, Cardiff University, Neuadd Meirionydd, Heath Park, Cardiff, United Kingdom, Wales; Centre for the Development and Evaluation of Complex Public Health Interventions for Public Health Improvement (DECIPHer), Cardiff University, United Kingdom, Wales. Electronic address: RoblingMR@cardiff.ac.uk.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104646']
1956,32780744,Comparison of alternative full and brief versions of functional status scales among older adults in China.,"BACKGROUND


Brief assessments of functional status for community-dwelling older adults are needed given expanded interest in the measurement of functional decline.
METHODS


As part of a 2015 prospective cohort study of older adults aged 60-89 years in Jiangsu Province, China, 1506 participants were randomly assigned to two groups; each group was administered one of two alternative 20-item versions of a scale to assess activities of daily living (ADL) and instrumental activities of daily living (IADL) drawn from multiple commonly-used scales. One version asked if they required help to perform activities (ADL-IADL-HELP-20), while the other version provided additional response options if activities could be done alone but with difficulty (ADL-IADL-DIFFICULTY-20). Item responses to both versions were compared using the binomial test for differences in proportion (with Wald 95% confidence interval [CI]). A brief 9-item scale (ADL-IADL-DIFFICULTY-9) was developed favoring items identified as difficult or requiring help by ≥4%, with low redundancy and/or residual correlations, and with significant correlations with age and other health indicators. We repeated assessment of the measurement properties of the brief scale in two subsequent samples of older adults in Hong Kong in 2016 (aged 70-79 years; n = 404) and 2017 (aged 65-82 years; n = 1854).
RESULTS


Asking if an activity can be done alone but with difficulty increased the proportion of participants reporting restriction on 9 of 20 items, for which 95% CI for difference scores did not overlap with zero; the proportion with at least one limitation increased from 28.6% to 34.2% or an absolute increase of 5.6% (95% CI = 0.9-10.3%), which was a relative increase of 19.6%. The brief ADL-IADL-DIFFICULTY-9 maintained excellent internal consistency (α = 0.93) and had similar ceiling effect (68.1%), invariant item ordering (H trans = .41; medium), and correlations with age and other health measures compared with the 20-item version. The brief scale performed similarly when subsequently administered to older adults in Hong Kong.
CONCLUSIONS


Asking if tasks can be done alone but with difficulty can modestly reduce ceiling effects. It's possible that the length of commonly-used scales can be reduced by over half if researchers are primarily interested in a summed indicator rather than an inventory of specific types of deficits.",2020,"Asking if an activity can be done alone but with difficulty increased the proportion of participants reporting restriction on 9 of 20 items, for which 95% CI for difference scores did not overlap with zero; the proportion with at least one limitation increased from 28.6% to 34.2% or an absolute increase of 5.6% (95% CI = 0.9-10.3%), which was a relative increase of 19.6%.","['older adults in Hong Kong', 'older adults in Hong Kong in 2016 (aged 70-79 years; n = 404) and 2017 (aged 65-82 years; n = 1854', 'community-dwelling older adults', 'older adults in China', 'older adults aged 60-89 years in Jiangsu Province, China, 1506 participants']",[],['activities of daily living (ADL) and instrumental activities of daily living (IADL'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0008115', 'cui_str': 'China'}]",[],"[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}]",1506.0,0.113087,"Asking if an activity can be done alone but with difficulty increased the proportion of participants reporting restriction on 9 of 20 items, for which 95% CI for difference scores did not overlap with zero; the proportion with at least one limitation increased from 28.6% to 34.2% or an absolute increase of 5.6% (95% CI = 0.9-10.3%), which was a relative increase of 19.6%.","[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Reich', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Thompson', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Cowling', 'Affiliation': 'WHO Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'A Danielle', 'Initials': 'AD', 'LastName': 'Iuliano', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Greene', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Yuyun', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'WHO Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Phadnis', 'Affiliation': 'Abt Associates, Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Nancy H L', 'Initials': 'NHL', 'LastName': 'Leung', 'Affiliation': 'WHO Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Vicky J', 'Initials': 'VJ', 'LastName': 'Fang', 'Affiliation': 'WHO Collaborating Centre for Infectious Disease Epidemiology and Control, School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong Special Administrative Region, China.'}, {'ForeName': 'Cuiling', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Chinese National Influenza Center, National Institute for Viral Disease Control and Prevention, Collaboration Innovation Center for Diagnosis and Treatment of Infectious Diseases, Chinese Center for Disease Control and Prevention, Beijing, China.'}, {'ForeName': 'Qigang', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Department of Acute Infectious Disease Control and Prevention, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Suzhou Center for Disease Prevention and Control, Suzhou, China.'}, {'ForeName': 'Hongjun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Yancheng Center for Disease Prevention and Control, Yancheng, China.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Havers', 'Affiliation': 'Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0234698']
1957,32780751,Implementation of an automated scheduling tool improves schedule quality and resident satisfaction.,"Rotation schedules for residents must balance individual preferences, compliance with Accreditation Council for Graduate Medical Education guidelines, and institutional staffing requirements. Automation has the potential to improve the consistency and quality of schedules. We designed a novel rotation scheduling tool, the Automated Internal Medicine Scheduler (AIMS), and evaluated schedule quality and resident satisfaction and perceptions of fairness after implementation. We compared schedule uniformity, fulfillment of resident preferences, and conflicting shift assignments for the hand-made 2017-2018 schedule, and the AIMS-generated 2018-2019 schedule. Residents were surveyed in September 2018 to assess perception of schedule quality and fairness. With AIMS, 71/74 (96.0%) interns and 66/82 (80.5%) residents were assigned to their first-choice rotation, a significant increase from the 50/72 (69.4%) interns and 25/82 (30.5%) residents assigned their first-choice in the 2017-2018 academic year. AIMS also yielded significant improvements in the number of night shift/day shift conflicts at the time of rotation switches for interns, with a significant decrease to 0.3 conflicts per intern compared to 0.7 with the prior manual schedule. Twenty-two of 82 residents (27%) completed the survey, and average satisfaction and perception of fairness were 0.7 and 0.9 points higher on a 5-point Likert scale for the AIMS-generated schedule when compared to the non-AIMS schedule. There was no significant difference in the preference for assigned vacation blocks, or in variance for night or ICU rotations. Automated scheduling improved several metrics of schedule quality, as well as resident satisfaction. Future directions include evaluation of the tool in other residency programs and comparison with alternative scheduling algorithms.",2020,"AIMS also yielded significant improvements in the number of night shift/day shift conflicts at the time of rotation switches for interns, with a significant decrease to 0.3 conflicts per intern compared to 0.7 with the prior manual schedule.",['residents assigned their first-choice in the 2017-2018 academic year'],[],"['number of night shift/day shift conflicts', 'schedule quality and resident satisfaction', 'average satisfaction and perception of fairness']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0266697,"AIMS also yielded significant improvements in the number of night shift/day shift conflicts at the time of rotation switches for interns, with a significant decrease to 0.3 conflicts per intern compared to 0.7 with the prior manual schedule.","[{'ForeName': 'Frederick M', 'Initials': 'FM', 'LastName': 'Howard', 'Affiliation': 'Section of Hematology/Oncology, Department of Medicine, University of Chicago, Chicago, Illinois, United States of America.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Gao', 'Affiliation': 'Division of Pulmonary/Critical Care, Department of Medicine, Northwestern University, Chicago, Illinois, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Sankey', 'Affiliation': 'Department of Internal Medicine, Yale New Haven Hospital, New Haven, Connecticut, United States of America.'}]",PloS one,['10.1371/journal.pone.0236952']
1958,32780752,Response to photodynamic therapy combined with intravitreal aflibercept for polypoidal choroidal vasculopathy depending on fellow-eye condition:2-year results.,"We investigated whether response to photodynamic therapy (PDT) with intravitreal aflibercept injection (IAI) for polypoidal choroidal vasculopathy (PCV) differs depending on fellow eye condition. A retrospective review was conducted for consecutive 60 eyes with PCV treated with PDT combined with IAI as well as 2-years of follow-up data. Fellow eyes were divided into 4 groups; Group 0: no drusen, Group 1; pachydrusen, Group 2; soft drusen, Group 3: PCV/fibrovascular scarring. Best-corrected visual acuity improved at 24-months irrespective of groups and there were no significant differences in visual improvement among treated eyes among the 4 groups. Within 2-years, 35 (58.3%) required the retreatment. The need for retreatment including additional injection and the combination therapy was significantly less in Group 1(12.5%) compared to the others (P = 0.0038) and mean number of additional IAI was also less in Group 1 compared to the others (P = 0.017). The retreatment-free period from the initial combination therapy was longest in Group 1 (23.6±1.1 months) (P = 0.0055, Group 0: 19.1±6.9, Group 2: 12.8±7.9, Group 3: 11.5±9.9). The need for retreatment was significantly different according to fellow-eye condition. Among PCV patients, pachydrusen in fellow eyes appear to be a predictive characteristic for a decreased treatment burden at 2 years.",2020,Best-corrected visual acuity improved at 24-months irrespective of groups and there were no significant differences in visual improvement among treated eyes among the 4 groups.,"['consecutive 60 eyes with PCV treated with PDT combined with IAI as well as 2-years of follow-up data', 'polypoidal choroidal vasculopathy depending on fellow-eye condition:2-year results']","['PCV/fibrovascular scarring', 'photodynamic therapy (PDT) with intravitreal aflibercept injection (IAI', 'photodynamic therapy combined with intravitreal aflibercept']","['Best-corrected visual acuity', 'visual improvement', 'mean number of additional IAI']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C1504336', 'cui_str': 'Polypoidal choroidal vasculopathy'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0104281', 'cui_str': 'AS 2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C1504336', 'cui_str': 'Polypoidal choroidal vasculopathy'}, {'cui': 'C0392759', 'cui_str': 'Fibrovascular'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}]",60.0,0.0237003,Best-corrected visual acuity improved at 24-months irrespective of groups and there were no significant differences in visual improvement among treated eyes among the 4 groups.,"[{'ForeName': 'Mio', 'Initials': 'M', 'LastName': 'Matsubara', 'Affiliation': 'Departments of Ophthalmology, Faculty of Medicine, University of Yamanashi, Kofu, Yamanashi, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Sakurada', 'Affiliation': 'Departments of Ophthalmology, Faculty of Medicine, University of Yamanashi, Kofu, Yamanashi, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Sugiyama', 'Affiliation': 'Departments of Ophthalmology, Faculty of Medicine, University of Yamanashi, Kofu, Yamanashi, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Fukuda', 'Affiliation': 'Departments of Ophthalmology, Faculty of Medicine, University of Yamanashi, Kofu, Yamanashi, Japan.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Parikh', 'Affiliation': 'New York University School of Medicine, New York, NY, United States of America.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Kashiwagi', 'Affiliation': 'Departments of Ophthalmology, Faculty of Medicine, University of Yamanashi, Kofu, Yamanashi, Japan.'}]",PloS one,['10.1371/journal.pone.0237330']
1959,32794483,"Serum vitamin D, vitamin D binding protein levels and leukocyte vitamin D receptor gene expression in patients with ischaemic stroke.","Objective


To investigate the possible contributions of serum 25 hydroxyvitamin D and vitamin D binding protein levels along with leukocyte vitamin D receptor gene expression in patients with ischaemic stroke.
METHODS


The randomised controlled single-blind study was conducted at the Mayo Hospital, Lahore, Pakistan, from September 2015 to September 2017, and comprised patients aged 40-75 years with Arbeitsgemeinschaft für Osteosynthesefragen type A2 and A3 per trochanteric fracture. The patients randomised into two equal groups. In Group A, patients were treated by closed reduction and internal fixation with dynamic hip screw, while those in Group B were treated by closed reduction and internal fixation by proximal femoral nail. Follow-up was done at 2nd, 6th and 12th weeks, and at 6th, 9th and 12th month post-operatively. Variables evaluated were frequency of union, surgical time, approximate amount of blood loss and complications. The functional assessment was done by using Harris hip score. SPSS 20 was used for data analysis.
RESULTS


Of the 90 subjects, 51 (56.6%) were cases with a mean age of 65.2±14.3 years, and 39 (43.3%) were controls with a mean age of 61.1±16.7 years. There was no difference between the groups with respect to vitamin D deficiency, serum vitamin D binding protein levels and leukocyte vitamin D receptor gene expressions (p>0.05). A negative correlation was found between 25-hydroxyvitamin D levels and the severity of ischaemic stroke (p=0.0342).
Conclusion


There was a correlation between serum 25-hydroxyvitamin D levels and severity of ischaemic stroke as assessed by the National Institutes of Health Stroke Scale.",2020,"There was no difference between the groups with respect to vitamin D deficiency, serum vitamin D binding protein levels and leukocyte vitamin D receptor gene expressions (p>0.05).","['Mayo Hospital, Lahore, Pakistan, from September 2015 to September 2017, and comprised patients aged 40-75 years with Arbeitsgemeinschaft für Osteosynthesefragen type A2 and A3 per trochanteric fracture', 'patients with ischaemic stroke', 'Of the 90 subjects, 51 (56.6%) were cases with a mean age of 65.2±14.3 years, and 39 (43.3%) were controls with a mean age of 61.1±16.7 years']","['closed reduction and internal fixation by proximal femoral nail', 'closed reduction and internal fixation with dynamic hip screw']","['serum 25-hydroxyvitamin D levels and severity of ischaemic stroke', '25-hydroxyvitamin D levels and the severity of ischaemic stroke', 'vitamin D deficiency, serum vitamin D binding protein levels and leukocyte vitamin D receptor gene expressions', 'Serum vitamin D, vitamin D binding protein levels and leukocyte vitamin D receptor gene expression', 'frequency of union, surgical time, approximate amount of blood loss and complications']","[{'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0162387', 'cui_str': 'Trochanteric Fractures'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0428586', 'cui_str': 'Serum vitamin D measurement'}, {'cui': 'C0242210', 'cui_str': 'Binding protein'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0108082', 'cui_str': 'Vitamin D3 Receptor'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0042872', 'cui_str': 'GC globulin'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.024754,"There was no difference between the groups with respect to vitamin D deficiency, serum vitamin D binding protein levels and leukocyte vitamin D receptor gene expressions (p>0.05).","[{'ForeName': 'Senol', 'Initials': 'S', 'LastName': 'Arslan', 'Affiliation': 'Department of Emergency Medicine, Erzurum Training and Research Hospital, Erzurum, Turkey.'}, {'ForeName': 'Elif Funda', 'Initials': 'EF', 'LastName': 'Sener', 'Affiliation': 'Department of Medical Biology, Erciyes University, Genom and Stem Cell Center, Kayseri, Turkey.'}, {'ForeName': 'Nahide Ekici', 'Initials': 'NE', 'LastName': 'Gunay', 'Affiliation': 'Department of Clinical Biochemistry, Kayseri Training and Research Hospital, Kayseri, Turkey.'}, {'ForeName': 'Seniz', 'Initials': 'S', 'LastName': 'Demiryurek', 'Affiliation': 'Department of Physiology, Gaziantep University, Gaziantep, Turkey.'}, {'ForeName': 'Uhut Rafi', 'Initials': 'UR', 'LastName': 'Gulderen', 'Affiliation': 'Department of Emergency Medicine, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Topaloglu', 'Affiliation': 'Department of Medical Biology, Erciyes University, Genom and Stem Cell Center, Kayseri, Turkey.'}, {'ForeName': 'Nurullah', 'Initials': 'N', 'LastName': 'Gunay', 'Affiliation': 'Department of Emergency Medicine, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Nurullah', 'Initials': 'N', 'LastName': 'Gunay', 'Affiliation': 'Department of Emergency Medicine, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Abdullah Tuncay', 'Initials': 'AT', 'LastName': 'Demiryurek', 'Affiliation': 'Department of Medical Pharmacology, Gaziantep University, Gaziantep, Turkey.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.987']
1960,32794567,Tofacitinib in Patients with Ulcerative Colitis: Inflammatory Bowel Disease Questionnaire Items in Phase 3 Randomized Controlled Induction Studies.,"BACKGROUND


Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). We examined the effect of tofacitinib induction treatment on Inflammatory Bowel Disease Questionnaire (IBDQ) items in adults with moderate to severe UC.
METHODS


Data were pooled from the randomized, 8‑week, double-blind, phase 3 OCTAVE Induction 1 and 2 studies. The IBDQ was self-administered by patients at baseline, week 4, and week 8, with higher scores indicating better health-related quality of life (HRQoL). Change from baseline in IBDQ items was analyzed for 10 mg of tofacitinib twice daily (BID) vs placebo using a linear mixed-effects model, with no multiplicity adjustment performed. Effect sizes were calculated. Subgroup analyses by tumor necrosis factor inhibitor (TNFi) experience were performed.
RESULTS


Significant improvements (nominal P < 0.05) were observed in all IBDQ items with 10 mg of tofacitinib BID vs placebo at weeks 4 and 8. For the overall population, the largest treatment differences across all items were reported for ""bowel movements been loose"" at weeks 4 and 8, and ""problem with rectal bleeding"" at week 8 (mean treatment differences all 1.1; both in bowel symptoms domain). These items also showed the largest effect sizes. Treatment benefits were generally slightly numerically higher in TNFi-experienced vs TNFi-naïve patients.
CONCLUSIONS


Tofacitinib induction therapy improved all IBDQ items vs placebo in patients with UC, reflecting improvements in HRQoL, with greatest benefits reported in bowel symptoms domain items (Funded by Pfizer Inc; OCTAVE Induction 1 and OCTAVE Induction 2; ClinicalTrials.gov, NCT01465763 and NCT01458951, respectively).",2020,"RESULTS


Significant improvements (nominal P < 0.05) were observed in all IBDQ items with 10 mg of tofacitinib BID vs placebo at weeks 4 and 8.","['Patients with Ulcerative Colitis', 'adults with moderate to severe UC', 'patients with UC']","['tofacitinib induction treatment', 'Tofacitinib', 'placebo']","['health-related quality of life (HRQoL', 'Inflammatory Bowel Disease Questionnaire (IBDQ) items', 'IBDQ items']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory bowel disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.238663,"RESULTS


Significant improvements (nominal P < 0.05) were observed in all IBDQ items with 10 mg of tofacitinib BID vs placebo at weeks 4 and 8.","[{'ForeName': 'Marla C', 'Initials': 'MC', 'LastName': 'Dubinsky', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'DiBonaventura', 'Affiliation': 'Pfizer Inc., New York, New York, USA.'}, {'ForeName': 'Haiyun', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Bushmakin', 'Affiliation': 'Pfizer Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Cappelleri', 'Affiliation': 'Pfizer Inc., Groton, Connecticut, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Maller', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Thorpe', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Salese', 'Affiliation': 'Pfizer Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Panés', 'Affiliation': 'Inflammatory Bowel Diseases Unit, Hospital Clínic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.'}]",Inflammatory bowel diseases,['10.1093/ibd/izaa193']
1961,32794582,"Oral 3-hydroxybutyrate ingestion decreases endogenous glucose production, lipolysis, and hormone-sensitive lipase phosphorylation in adipose tissue in men: a human randomized, controlled, crossover trial.","AIMS


To test whether oral administration of D/L-3-hydroxybutyrate as a sodium salt inhibits lipolysis and intracellular lipid signalling, in particular, hormone-sensitive lipase, and whether D/L-3-hydroxybutyrate alters endogenous glucose production.
METHODS


We studied six young men in a randomized, controlled, crossover study after ingestion of Na-D/L-3-hydroxybutyrate (hyperketotic condition) or saline (placebo control). We quantified lipolysis and endogenous glucose production using [9,10- 3  H]-palmitate and [3-3H]glucose tracers, and adipose tissue biopsies were collected to investigate key lipolytic enzymes.
RESULTS


After ingestion, D/L-3-hydroxybutyrate increased >2.5 mmol/l, free fatty acid concentrations decreased by >70%, and palmitate rate of appearance was halved. Protein kinase A phosphorylation of perilipin was reduced and hormone-sensitive lipase 660 phosphorylation in adipose tissue biopsies was 70-80% decreased in the hyperketotic condition and unchanged in the control. Compared to the control, endogenous glucose production was reduced by close to 20% (P<0.05) after 3-hydroxybutyrate ingestion.
CONCLUSION


We conclude that oral D/L-Na-3-hydroxybutyrate increases D/L-3-hydroxybutyrate concentrations within half an hour, decreases free fatty acid concentrations, lowers lipolysis and endogenous glucose production, and dephosphorylates hormone-sensitive lipase. Collectively these phenomena may be viewed as an orchestrated feedback loop, controlling endogenous glucose production, lipolysis and ketogenesis. Such effects would be beneficial in insulin-resistant states.",2020,"Compared to the control, endogenous glucose production was reduced by close to 20% (P<0.05) after 3-hydroxybutyrate ingestion.
","['adipose tissue in men', 'six young men']","['ingestion of Na-D/L-3-hydroxybutyrate (hyperketotic condition) or saline (placebo control', 'Oral 3-hydroxybutyrate ingestion', 'oral D/L-Na-3-hydroxybutyrate', 'D/L-3-hydroxybutyrate']","['palmitate rate of appearance', 'endogenous glucose production', 'D/L-3-hydroxybutyrate concentrations', 'free fatty acid concentrations, lowers lipolysis and endogenous glucose production, and dephosphorylates hormone-sensitive lipase', 'free fatty acid concentrations', 'adipose tissue biopsies']","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0604267', 'cui_str': 'L-3'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0106006', 'cui_str': '3-hydroxybutyrate'}]","[{'cui': 'C0030233', 'cui_str': 'Hexadecanoates'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0604267', 'cui_str': 'L-3'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0008385', 'cui_str': 'Cholesterol esterase'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",6.0,0.0523582,"Compared to the control, endogenous glucose production was reduced by close to 20% (P<0.05) after 3-hydroxybutyrate ingestion.
","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Svart', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Rittig', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Pedersen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Jessen', 'Affiliation': 'Clinical Pharmacology, Aarhus University Hospital, Denmark.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Møller', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Denmark.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14385']
1962,32794658,Application of three dimensional (3D) curved multi-planar reconstruction images in 3D printing mold assisted eyebrow arch keyhole microsurgery.,"OBJECTIVE


The application of multi-planar reconstruction of three dimensional (3D) curved surface in microsurgery of 3D printing mold assisted eyebrow arch keyhole approach was studied.
METHODS


Eighty patients with intracranial aneurysms who underwent treatment at our hospital were enrolled. The patients were divided into two groups: the traditional eyebrow keyhole approach microsurgery group (38 cases in the conventional treatment group) and the three-dimensional curved surface multi-plane reconstruction image combined with 3D printing technology assisted eyebrow keyhole approach microsurgery group (42 cases in the 3D printing assisted treatment group). The Hunt-Hess classification was used to make a preliminary estimation of the patient's condition. The 3D curved multi-planar reconstruction method was used to assist the surgical plan; CT scan was used to establish a 3D printing mold, and the patient's condition and surgical plan were accurately analyzed before surgery. The operative time and the size of the incision area were recorded; postoperative GOS score and postoperative complications were statistically investigated.
RESULTS


The 3D printing assisted treatment group (70.13 ± 15.56), (411.26 ± 10.38) mm 2  , the operative time and incision area were significantly shorter than the conventional treatment group (120.35 ± 20.46), (663.55 ± 13.54) mm 2  , p < .05); the GOS score showed that the 3D printing-assisted treatment group was significantly higher than the conventional treatment group (p < .05). The postoperative complication rate was significantly lower in the 3D print-assisted treatment group (9.52%) than in the conventional treatment group (47.36%, p < .05); the cure of intracranial aneurysms in the 3D printing assisted treatment group was more thorough than that in the conventional treatment group, and the difference was significant (p < .05).
CONCLUSION


Compared with the conventional eyebrow arch-hole approach microsurgery, the 3D surface multi-planar reconstruction image combined 3D printing assisted technology was safer and more effective, and the postoperative recovery was better and the incidence of complications was lower.",2020,"The postoperative complication rate was significantly lower in the 3D print-assisted treatment group (9.52%) than in the conventional treatment group (47.36%, p < .05); the cure of intracranial aneurysms in the 3D printing assisted treatment group was more thorough than that in the conventional treatment group, and the difference was significant (p < .05).
",['Eighty patients with intracranial aneurysms who underwent treatment at our hospital were enrolled'],"['three dimensional (3D) curved multi-planar reconstruction images', 'traditional eyebrow keyhole approach microsurgery group (38 cases in the conventional treatment group) and the three-dimensional curved surface multi-plane reconstruction image combined with 3D printing technology assisted eyebrow keyhole approach microsurgery group']","['operative time and incision area', 'postoperative complication rate', 'GOS score', 'operative time and the size of the incision area', 'postoperative GOS score and postoperative complications', 'cure of intracranial aneurysms']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0205133', 'cui_str': 'Bent'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0015420', 'cui_str': 'Eyebrow structure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0026035', 'cui_str': 'Microsurgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0007766', 'cui_str': 'Intracranial aneurysm'}]",80.0,0.0190235,"The postoperative complication rate was significantly lower in the 3D print-assisted treatment group (9.52%) than in the conventional treatment group (47.36%, p < .05); the cure of intracranial aneurysms in the 3D printing assisted treatment group was more thorough than that in the conventional treatment group, and the difference was significant (p < .05).
","[{'ForeName': 'Sheng-Jun', 'Initials': 'SJ', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, Linyi Central Hospital, Linyi, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Neurosurgery, Linyi Central Hospital, Linyi, China.'}]",Brain and behavior,['10.1002/brb3.1785']
1963,32794673,[Optimized preparation method of leukocytes-rich platelet-rich plasma by varying conditions during centrifugation].,"Objective


To identify a more popularized preparation protocol of leukocytes-rich platelet-rich plasma (L-PRP) for higher tolerance rate.
Methods


The peripheral blood samples of 76 volunteers (45.0 mL/case) were mixed with 5 mL sodium citrate injection for blood transfusion, and L-PRP was prepared by twice centrifugations. All blood samples were divided into three groups according to the parameters of twice centrifugation: experimental group A (12 cases, 400×  g , 10 minutes for the first time and 1 100×  g , 10 minutes for the second time), experimental group B (27 cases, 800×  g , 10 minutes for the first time and 1 100×  g , 10 minutes for the second time), and control group (37 cases, 1 360×  g , 10 minutes for the first time and 1 360×  g , 10 minutes for the second time). The platelet recovery rate and platelet and leukocyte enrichment coefficient of L-PRP in each group were calculated and compared.
Results


After removal of abnormal blood samples (platelet recovery rate was more than 100% or white thrombus), the remaining 55 cases were included in the statistical analysis, including 10 cases in experimental group A, 21 cases in experimental group B, and 24 cases in control group. The platelet enrichment coefficient and platelet recovery rate of experimental group B were significantly higher than those of experimental group A and control group (  P <0.05); there was no significant difference between experimental group A and control group (  P >0.05). There was no significant difference in leukocyte enrichment coefficient between experimental groups A, B, and control group (  P >0.05).
Conclusion


The preparation quality of PRP is affected by various factors, including centrifugal force, centrifugal time, temperature, and operation process,  etc . Twice centrifugation (800×  g , 10 minutes for the first time and 1 100×  g , 10 minutes for the second time) is an ideal and feasible centrifugation scheme, which can obtain satisfactory platelet recovery rate and enrichment coefficient with thicker buffy coat, which can reduce the fine operation requirements for operators, improve the fault tolerance rate and generalization.",2020,The platelet enrichment coefficient and platelet recovery rate of experimental group B were significantly higher than those of experimental group A and control group (  P <0.05); there was no significant difference between experimental group A and control group (  P >0.05).,['76 volunteers (45.0 mL/case'],"['leukocytes-rich platelet-rich plasma (L-PRP', 'Twice centrifugation']","['abnormal blood samples (platelet recovery rate', 'leukocyte enrichment coefficient', 'platelet enrichment coefficient and platelet recovery rate', 'platelet recovery rate and platelet and leukocyte enrichment coefficient of L-PRP']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0007703', 'cui_str': 'Centrifugation'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}]",,0.0113833,The platelet enrichment coefficient and platelet recovery rate of experimental group B were significantly higher than those of experimental group A and control group (  P <0.05); there was no significant difference between experimental group A and control group (  P >0.05).,"[{'ForeName': 'Zhaoyuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}, {'ForeName': 'Yuxuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': '.'}, {'ForeName': 'Changqing', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yuan', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 200233, P.R.China.""}]",Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery,['10.7507/1002-1892.201911054']
1964,32790718,Stepped-care versus treatment as usual in panic disorder: A randomized controlled trial.,"Stepped-care (SC) models for anxiety disorders are implemented on a large scale and are assumed to be as effective for the greater majority of patients as more intensive treatment schemes. To compare the outcomes of SC and international guideline-based treatment (Treatment as Usual: TAU) for panic disorder, a total of 128 patients were randomized to either SC or TAU (ratio 2: 1, respectively) using a computer generated algorithm. They were treated in four mental health care centres in the Netherlands after therapists had been trained in SC by a senior expert therapist. SC comprised 10-week guided self-help (pen-and-paper version) followed, if indicated, by 13-week manualized face-to-face cognitive behavioural therapy (CBT), with medication- if prescribed- kept constant. TAU consisted of 23-week regular face-to-face CBT (RCBT) with medication -when prescribed- also kept constant. The means of the attended sessions in the SC condition was 5.9 (SD = 4.8) for ITT and 9.6 (SD = 9.6) for the RCBT condition. The difference in the number of attended sessions between the conditions was significant (t(126) = -3.87, p < .001). Remission rates between treatment conditions did not differ significantly (SC: 44.5%; RCBT: 53.3%) and symptom reduction was similar. Stepping up SC treatment to face-to-face CBT showed a minimal additional effect. Importantly, drop-out rates differed significantly for the two conditions (SC: 48.2%; RCBT: 26.7%). SC was effective in the treatment of panic disorder in terms of symptom reduction and remission rate, but dropout rates were twice as high as those seen in RCBT, with the second phase of SC not substantially improving treatment response. However, SC required significantly less therapist contact time compared to RCBT, and more research is needed to explore predictors of success for guided self-help interventions to allow treatment intensity to be tailored to patients' needs and preferences.",2020,"SC was effective in the treatment of panic disorder in terms of symptom reduction and remission rate, but dropout rates were twice as high as those seen in RCBT, with the second phase of SC not substantially improving treatment response.","['They were treated in four mental health care centres in the Netherlands after therapists had been trained in SC by a senior expert therapist', 'panic disorder, a total of 128 patients']","['manualized face-to-face cognitive behavioural therapy (CBT), with medication- if prescribed- kept constant', 'SC and international guideline-based treatment (Treatment as Usual: TAU', 'SC', 'SC or TAU']","['therapist contact time', 'remission rate', 'symptom reduction', 'Remission rates', 'number of attended sessions']","[{'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}]","[{'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",128.0,0.0572331,"SC was effective in the treatment of panic disorder in terms of symptom reduction and remission rate, but dropout rates were twice as high as those seen in RCBT, with the second phase of SC not substantially improving treatment response.","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Kampman', 'Affiliation': 'Overwaal, Centre of Expertise for Anxiety Disorders, OCD, and PTSD part of Institute for Integrated Mental Health Care ""Pro Persona"", Nijmegen, The Netherlands.'}, {'ForeName': 'Anton J L M', 'Initials': 'AJLM', 'LastName': 'van Balkom', 'Affiliation': 'Amsterdam UMC, Psychiatry, Amsterdam Public Health Research Institute and GGZ inGeest, Specialized Mental Health Care, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Broekman', 'Affiliation': 'Bureau Bêta, Nijmegen, The Netherlands.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Verbraak', 'Affiliation': 'Behavioural Science Institute, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Hendriks', 'Affiliation': 'Overwaal, Centre of Expertise for Anxiety Disorders, OCD, and PTSD part of Institute for Integrated Mental Health Care ""Pro Persona"", Nijmegen, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0237061']
1965,32790725,"Effect of lipid-based nutrient supplement-Medium quantity on reduction of stunting in children 6-23 months of age in Sindh, Pakistan: A cluster randomized controlled trial.","BACKGROUND


Chronic childhood malnutrition, or stunting, remains a persistent barrier to achieve optimal cognitive development, child growth and ability to reach full potential. Almost half of children under-five years of age are stunted in the province of Sindh, Pakistan.
OBJECTIVE


The primary objective of this study was to test the hypothesis that the provision of lipid-based nutrient supplement-medium-quantity (LNS-MQ) known as Wawamum will result in a 10% reduction in risk of being stunted at the age of 24 months in the intervention group compared with the control group.
DESIGN


A cluster randomized controlled trial was conducted in Thatta and Sujawal districts of Sindh province, Pakistan. A total of 870 (419 in intervention; 451 in control) children between 6-18 months old were enrolled in the study. The unit of randomization was union council and considered as a cluster. A total of 12 clusters, 6 in each study group were randomly assigned to intervention and control group. All children received standard government health services, while children in the intervention group also received 50 grams/day of Wawamum.
RESULTS


Children who received Wawamum were found to have a significantly reduced risk of stunting (RR = 0.91, 95% CI; 0.88-0.94, p<0.001) and wasting (RR = 0.78, 95% CI; 0.67-0.92, p = 0.004) as compared to children who received the standard government health services. There was no evidence of a reduction in the risk of underweight (RR = 0.94, 95% CI; 0.85-1.04, p = 0.235) in the intervention group compared to the control group. Statistically significant reduction in anaemia in the intervention group was also found as compared to the control group (RR = 0.97, 95% CI; 0.94-0.99, p = 0.042). The subgroup analysis by age, showed intervention effect is significant in reduction of risk of stunting in younger children of aged 6-12 month (RR = 0.83, 95% CI; 0.81-0.86, p = <0.001) and their older peers aged 13-18 month- (RR = 0.90, 95% CI; 0.83-0.97, p = 0.008). The mean compliance of Wawamum was 60% among children.
CONCLUSIONS


The study confirmed that the provision of Wawamum to children 6-23 months of age is effective in reducing the risk of stunting, wasting and anaemia. This approach should be scaled up among the most food insecure areas/households with a high prevalence of stunting to achieve positive outcomes for nutrition and health. This study was registered at clinicaltrials.gov as NCT02422953. Clinical Trial Registration Number: NCT02422953.",2020,"The subgroup analysis by age, showed intervention effect is significant in reduction of risk of stunting in younger children of aged 6-12 month (RR = 0.83, 95% CI; 0.81-0.86, p = <0.001) and their older peers aged 13-18 month- (RR = 0.90, 95% CI; 0.83-0.97, p = 0.008).","['A total of 870 (419 in intervention; 451 in control) children between 6-18 months old were enrolled in the study', 'children 6-23 months of age in Sindh, Pakistan', 'Thatta and Sujawal districts of Sindh province, Pakistan']","['standard government health services', 'lipid-based nutrient supplement-medium-quantity (LNS-MQ', 'lipid-based nutrient supplement-Medium quantity']","['reduction of stunting', 'risk of underweight', 'mean compliance of Wawamum', 'risk of stunting', 'reduction of risk of stunting', 'anaemia', 'risk of stunting, wasting and anaemia']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C5191282', 'cui_str': '451'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}]",870.0,0.144529,"The subgroup analysis by age, showed intervention effect is significant in reduction of risk of stunting in younger children of aged 6-12 month (RR = 0.83, 95% CI; 0.81-0.86, p = <0.001) and their older peers aged 13-18 month- (RR = 0.90, 95% CI; 0.83-0.97, p = 0.008).","[{'ForeName': 'Gul Nawaz', 'Initials': 'GN', 'LastName': 'Khan', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Sumra', 'Initials': 'S', 'LastName': 'Kureishy', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Shabina', 'Initials': 'S', 'LastName': 'Ariff', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Arjumand', 'Initials': 'A', 'LastName': 'Rizvi', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Sajid', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Garzon', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Ali Ahmad', 'Initials': 'AA', 'LastName': 'Khan', 'Affiliation': 'World Food Programme, Islamabad, Pakistan.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'de Pee', 'Affiliation': 'World Food Programme, Rome, Italy.'}, {'ForeName': 'Sajid Bashir', 'Initials': 'SB', 'LastName': 'Soofi', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Department of Paediatrics and Child Health, Aga Khan University, Karachi, Pakistan.'}]",PloS one,['10.1371/journal.pone.0237210']
1966,32790734,"Comparison of the MultiViewScope Stylet Scope and the direct laryngoscope with the Miller blade for the intubation in normal and difficult pediatric airways: A randomized, crossover, manikin study.","BACKGROUND


Managing difficult pediatric airway is challenging. The MultiViewScope (MVS) Stylet Scope is reported to be useful in difficult pediatric airway. In this randomized crossover study, we compared the effectiveness of the MVS Stylet Scope to a standard direct laryngoscope with Miller #1 blade in simulated normal and difficult airways.
METHODS


Fifteen expert anesthesiologists and Fifteen anesthesiology residents participated in the study. Participants were asked to perform intubation with the Airsim Baby manikin first, and then with the Airsim Pierre Robin manikin. Participants in each group used the intubation devices in a randomized order. The primary outcome was the time of successful intubation. The secondary outcomes were the force exerted on the incisors during intubation, Cormack-Lehane scale, the difficulty of intubation.
RESULTS


There were no differences between MVS Stylet Scope and Direct laryngoscope in the time of successful intubation by the expert anesthesiologists or the anesthesiology residents in a normal or difficult pediatric airway. MVS Stylet Scope significantly improved the force exerted on the incisors during intubation in the expert anesthesiologists or the anesthesiology residents in a normal or difficult pediatric airway. MVS Stylet Scope significantly improved Cormack-Lehane scale, and the difficulty of intubation with difficult pediatric airway situation in both expert anesthesiologists and anesthesiology residents.
CONCLUSIONS


Although less forces on the incisors and improved view of glottis were observed with the MVS Stylet Scope, MVS Stylet Scope did not shorten the time of intubation. The results of this study mean that the MVS Stylet Scope may be a less invasive airway devise than the direct laryngoscope with the Miller blade in the pediatric airway management. For the next step, we need to evaluate the MVS Stylet Scope in the real patients as an observational study.",2020,There were no differences between MVS Stylet Scope and Direct laryngoscope in the time of successful intubation by the expert anesthesiologists or the anesthesiology residents in a normal or difficult pediatric airway.,"['Fifteen expert anesthesiologists and Fifteen anesthesiology residents participated in the study', 'normal and difficult pediatric airways']","['MultiViewScope', 'direct laryngoscope with the Miller blade', 'MVS Stylet Scope']","['time of intubation', 'time of successful intubation', 'MultiViewScope (MVS', 'Cormack-Lehane scale', 'force exerted on the incisors during intubation, Cormack-Lehane scale, the difficulty of intubation']","[{'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0183663', 'cui_str': 'Stylet'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",,0.0337827,There were no differences between MVS Stylet Scope and Direct laryngoscope in the time of successful intubation by the expert anesthesiologists or the anesthesiology residents in a normal or difficult pediatric airway.,"[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Godai', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Moriyama', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Kanmura', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan.'}]",PloS one,['10.1371/journal.pone.0237593']
1967,32781940,Effects of Inhibition of Nitric Oxide Synthase on Muscular Arteries During Exercise: Nitric Oxide Does Not Contribute to Vasodilation During Exercise or in Recovery.,"Background Basal release of nitric oxide (NO) from the vascular endothelium regulates the tone of muscular arteries and resistance vasculature. Effects of NO on muscular arteries could be particularly important during exercise when shear stress may stimulate increased NO synthesis. Methods and Results We investigated acute effects of NO synthase inhibition on exercise hemodynamics using N G -monomethyl-l-arginine (l-NMMA), a nonselective NO synthase -inhibitor. Healthy volunteers (n=10, 5 female, 19-33 years) participated in a 2-phase randomized crossover study, receiving l-NMMA (6 mg/kg, iv over 5 minutes) or placebo before bicycle exercise (25-150 W for 12 minutes). Blood pressure, cardiac output (measured by dilution of soluble and inert tracers) and femoral artery diameter were measured before, during, and after exercise. At rest, l-NMMA reduced heart rate (by 16.2±4.3 bpm relative to placebo,  P <0.01), increased peripheral vascular resistance (by 7.0±1.4 mmHg per L/min,  P <0.001), mean arterial blood pressure (by 8.9±3.5 mmHg,  P <0.05), and blunted an increase in femoral artery diameter that occurred immediately before exercise (change in diameter: 0.14±0.04 versus 0.32±0.06 mm after l-NMMA and placebo,  P <0.01). During/after exercise l-NMMA had no significant effect on peripheral resistance, cardiac output, or on femoral artery diameter. Conclusions These results suggest that NO plays little role in modulating muscular artery function during exercise but that it may mediate changes in muscular artery tone immediately before exercise.",2020,"At rest, l-NMMA reduced heart rate (by 16.2±4.3 bpm relative to placebo,  P <0.01), increased peripheral vascular resistance (by 7.0±1.4 mmHg per L/min,  P <0.001), mean arterial blood pressure (by 8.9±3.5 mmHg,  P <0.05), and blunted an increase in femoral artery diameter that occurred immediately before exercise (change in diameter: 0.14±0.04 versus 0.32±0.06 mm after l-NMMA and placebo,  P <0.01).","['Muscular Arteries', 'Healthy volunteers (n=10, 5 female, 19-33\xa0years']","['receiving l-NMMA', 'N G -monomethyl-l-arginine (l-NMMA', 'NO synthase inhibition', 'nitric oxide (NO', 'Nitric Oxide Synthase', 'placebo before bicycle exercise']","['peripheral resistance, cardiac output, or on femoral artery diameter', 'femoral artery diameter', 'Blood pressure, cardiac output (measured by dilution of soluble and inert tracers) and femoral artery diameter', 'heart rate', 'peripheral vascular resistance', 'mean arterial blood pressure']","[{'cui': 'C0226002', 'cui_str': 'Structure of medium artery'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0069477', 'cui_str': 'NG-Monomethyl-L-Arginine'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0132555', 'cui_str': 'Nitric-oxide synthase'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}]",,0.205493,"At rest, l-NMMA reduced heart rate (by 16.2±4.3 bpm relative to placebo,  P <0.01), increased peripheral vascular resistance (by 7.0±1.4 mmHg per L/min,  P <0.001), mean arterial blood pressure (by 8.9±3.5 mmHg,  P <0.05), and blunted an increase in femoral artery diameter that occurred immediately before exercise (change in diameter: 0.14±0.04 versus 0.32±0.06 mm after l-NMMA and placebo,  P <0.01).","[{'ForeName': 'Kevin', 'Initials': 'K', 'LastName': ""O'Gallagher"", 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Husain', 'Initials': 'H', 'LastName': 'Shabeeh', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Shahzad', 'Initials': 'S', 'LastName': 'Munir', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Roomi', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Benyu', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Guilcher', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Brett', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Chowienczyk', 'Affiliation': ""Cardiovascular Division Department of Clinical Pharmacology King's College London School of Medicine St Thomas' Hospital London United Kingdom.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.013849']
1968,32781991,Correction to: Effectiveness of a theory-based back care intervention on spine-related behavior among pupils: a school-based randomised controlled trial (T-Bak study).,An amendment to this paper has been published and can be accessed via the original article.,2020,An amendment to this paper has been published and can be accessed via the original article.,['spine-related behavior among pupils'],['theory-based back care intervention'],[],"[{'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0204750', 'cui_str': 'Special back care'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.029166,An amendment to this paper has been published and can be accessed via the original article.,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Akbari-Chehrehbargh', 'Affiliation': 'Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Sedigheh Sadat', 'Initials': 'SS', 'LastName': 'Tavafian', 'Affiliation': 'Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. Tavafian@modares.ac.ir.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Montazeri', 'Affiliation': 'Health Metrics Research Center, Iranian Institutes for Health Sciences Research, ACECR, Tehran, Iran. montazeri@acecr.ac.ir.'}]",BMC public health,['10.1186/s12889-020-09200-8']
1969,32781992,A short course of oral ranitidine as a novel treatment for toddler's diarrhea: a parallel-group randomized controlled trial.,"BACKGROUND


The current paradigm for treating toddler's diarrhea comprises dietary modification and fluid restriction. Previous studies show that probiotics and proton-pump inhibitors (PPIs) or H 2  blockers could control diarrhea associated with functional gastrointestinal disorders (FGIDs). This study aims to determine and compare the efficacy of a short course of oral ranitidine and a probiotic in the treatment of toddler's diarrhea.
METHODS


This study was a parallel-group randomized controlled trial (RCT). We sequentially enrolled 40 patients who met the eligibility criteria. We randomly assigned 20 patients to the oral ranitidine group, ten patients to the probiotic group, and ten patients to the placebo group. In the oral ranitidine group, patients received oral ranitidine (3 mg/kg/day) once daily for 10 days; in the probiotic and placebo groups, they were administered 5 to 10 billion colony-forming units (CFUs) per day of lyophilized Lactobacillus rhamnosus and 50 mg of once-daily oral vitamin C tablet respectively for 10 days. Stool frequency and consistency on the 10th day of the interventions were recorded as the primary outcomes. We used the Student's t-test to determine if there were significant differences in the mean daily stool frequencies in the three intervention groups. A p-value < 0.05 was adopted as the level of statistical significance.
RESULTS


In the ranitidine group, stool frequency decreased significantly from an average of five per day on the first day to an average of approximately one per day on the 10th day of intervention (t = 10.462, p <  0.001). Additionally, stool consistency normalized on the 10th day of intervention. In the probiotic group, there was a significant reduction in stool frequency from an average of five per day on the first day to four per day on the 10th day (t = 2.586, p = 0.041), although stool consistency remained loose. However, stool consistency and frequency were not significantly affected in the placebo group (t = 1.964, p = 0.072).
CONCLUSION


Oral ranitidine is more effective than probiotics in reducing stool frequency and normalizing stool consistency in toddler's diarrhea. We recommend multi-center trials with appropriate study designs to confirm and validate this finding.
TRIAL REGISTRATION


ISRCTN, ISRCTN10783996 . Registered 8 April 2016-Registered retrospectively.",2020,"However, stool consistency and frequency were not significantly affected in the placebo group (t = 1.964, p = 0.072).
","[""toddler's diarrhea"", '40 patients who met the eligibility criteria']","['oral ranitidine', 'lyophilized Lactobacillus rhamnosus and 50\u2009mg of once-daily oral vitamin C tablet', 'probiotics and proton-pump inhibitors (PPIs', 'probiotic and placebo', 'ranitidine', 'placebo']","['stool frequency', 'stool consistency and frequency', 'mean daily stool frequencies', 'Stool frequency and consistency', 'stool frequency and normalizing stool consistency']","[{'cui': 'C0473132', 'cui_str': 'Toddler diarrhea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0034665', 'cui_str': 'Ranitidine'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]",40.0,0.0825863,"However, stool consistency and frequency were not significantly affected in the placebo group (t = 1.964, p = 0.072).
","[{'ForeName': 'Samuel N', 'Initials': 'SN', 'LastName': 'Uwaezuoke', 'Affiliation': 'Department of Pediatrics, University of Nigeria of Nigeria Teaching Hospital Ituku-Ozalla Enugu/College of Medicine, University of Nigeria Enugu Campus, Enugu, Nigeria. snuwaezuoke@yahoo.com.'}, {'ForeName': 'Ikenna K', 'Initials': 'IK', 'LastName': 'Ndu', 'Affiliation': 'Department of Pediatrics, Enugu State University Teaching Hospital, Parklane, Enugu, Nigeria.'}, {'ForeName': 'Chizoma I', 'Initials': 'CI', 'LastName': 'Eneh', 'Affiliation': 'Department of Pediatrics, Enugu State University Teaching Hospital, Parklane, Enugu, Nigeria.'}, {'ForeName': 'Chikere A', 'Initials': 'CA', 'LastName': 'Anusiem', 'Affiliation': 'Department of Pharmacology and Therapeutics, College of Medicine, University of Nigeria Enugu Campus, Enugu, Nigeria.'}, {'ForeName': 'Adaeze C', 'Initials': 'AC', 'LastName': 'Ayuk', 'Affiliation': 'Department of Pediatrics, University of Nigeria of Nigeria Teaching Hospital Ituku-Ozalla Enugu/College of Medicine, University of Nigeria Enugu Campus, Enugu, Nigeria.'}]",BMC pediatrics,['10.1186/s12887-020-02267-7']
1970,32780739,"The effect of an airflow restriction mask (ARM) on metabolic, ventilatory, and electromyographic responses to continuous cycling exercise.","This study analyzed the physiological adjustments caused by the use of the Elevation training mask® (2.0), an airflow restriction mask (ARM) during continuous exercise. Eighteen physically active participants (12 men and 6 women) were randomized to two protocols: continuous exercise with mask (CE-ARM) and continuous exercise without mask (CE). Exercise consisted of cycling for 20 minutes at 60% of maximum power. Metabolic variables, lactate, and gas concentration were obtained from arterialized blood samples at pre and post exercise. Continuous expired gases and myoelectric activity of the quadriceps were performed at rest and during the test. We observed no reduction in oxygen saturation in CE-ARM, leading to lower pH, higher carbon dioxide, and greater hematocrit (all p <0.05). The expired gas analysis shows that the CE-ARM condition presented higher oxygen uptake and expired carbon dioxide concentrations (p <0.05). The CE-ARM condition also presented lower ventilatory volume, ventilatory frequency, and expired oxygen pressure (p <0.05). No changes in electromyography activity and lactate concentrations were identified. We conclude that using ARM does not induce hypoxia and represents an additional challenge for the control of acid-base balance, and we suggest the use of ARM as being suitable for respiratory muscle training.",2020,No changes in electromyography activity and lactate concentrations were identified.,['Eighteen physically active participants (12 men and 6 women'],"['airflow restriction mask (ARM', 'Elevation training mask® (2.0), an airflow restriction mask (ARM', 'continuous exercise with mask (CE-ARM) and continuous exercise without mask (CE', 'continuous cycling exercise']","['metabolic, ventilatory, and electromyographic responses', 'Metabolic variables, lactate, and gas concentration', 'electromyography activity and lactate concentrations', 'oxygen saturation in CE-ARM, leading to lower pH, higher carbon dioxide, and greater hematocrit', 'oxygen uptake and expired carbon dioxide concentrations', 'ventilatory volume, ventilatory frequency, and expired oxygen pressure']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0728725', 'cui_str': 'Low pH'}, {'cui': 'C0860713', 'cui_str': 'Carbon dioxide increased'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0428653', 'cui_str': 'Carbon dioxide concentration'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",18.0,0.0240789,No changes in electromyography activity and lactate concentrations were identified.,"[{'ForeName': 'João Francisco', 'Initials': 'JF', 'LastName': 'Barbieri', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Arthur Fernandes', 'Initials': 'AF', 'LastName': 'Gáspari', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Cassia Lopes', 'Initials': 'CL', 'LastName': 'Teodoro', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Motta', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Luz Albany Arcila', 'Initials': 'LAA', 'LastName': 'Castaño', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Romulo', 'Initials': 'R', 'LastName': 'Bertuzzi', 'Affiliation': 'Endurance Performance Research (GEDAE-USP), School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Celene Fernandes', 'Initials': 'CF', 'LastName': 'Bernades', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Mara Patrícia Traina', 'Initials': 'MPT', 'LastName': 'Chacon-Mikahil', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Antonio Carlos', 'Initials': 'AC', 'LastName': 'de Moraes', 'Affiliation': 'Department of Sport Science, School of Physical Education, University of Campinas, Campinas, Brazil.'}]",PloS one,['10.1371/journal.pone.0237010']
1971,32787879,"Omega-3 polyunsaturated fatty acid supplementation versus placebo on vascular health, glycaemic control, and metabolic parameters in people with type 1 diabetes: a randomised controlled preliminary trial.","BACKGROUND


The role of omega-3 polyunsaturated fatty acids (n-3PUFA), and the potential impact of n-3PUFA supplementation, in the treatment and management of type 1 diabetes (T1D) remains unclear and controversial. Therefore, this study aimed to examine the efficacy of daily high-dose-bolus n-3PUFA supplementation on vascular health, glycaemic control, and metabolic parameters in subjects with T1D.
METHODS


Twenty-seven adults with T1D were recruited to a 6-month randomised, double-blind, placebo-controlled trial. Subjects received either 3.3 g/day of encapsulated n-3PUFA or encapsulated 3.0 g/day corn oil placebo (PLA) for 6-months, with follow-up at 9-months after 3-month washout. Erythrocyte fatty acid composition was determined via gas chromatography. Endpoints included inflammation-associated endothelial biomarkers (vascular cell adhesion molecule-1 [VCAM-1], intercellular adhesion molecule-1 [ICAM-1], E-selectin, P-selectin, pentraxin-3, vascular endothelial growth factor [VEGF]), and their mediator tumor necrosis factor alpha [TNFα] analysed via immunoassay, vascular structure (carotid intima-media thickness [CIMT]) and function (brachial artery flow mediated dilation [FMD]) determined via ultrasound technique, blood pressure, glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), and postprandial metabolism.
RESULTS


Twenty subjects completed the trial in full. In the n-3PUFA group, the mean ± SD baseline n-3PUFA index of 4.93 ± 0.94% increased to 7.67 ± 1.86% (P < 0.001) after 3-months, and 8.29 ± 1.45% (P < 0.001) after 6-months. Total exposure to n-3PUFA over the 6-months (area under the curve) was 14.27 ± 3.05% per month under n-3PUFA, and 9.11 ± 2.74% per month under PLA (P < 0.001). VCAM-1, ICAM-1, E-selectin, P-selectin, pentraxin-3, VEGF, TNFα, CIMT, FMD, blood pressure, HbA1c, FPG, and postprandial metabolism did not differ between or within groups after treatment (P > 0.05).
CONCLUSIONS


This study indicates that daily high-dose-bolus of n-3PUFA supplementation for 6-months does not improve vascular health, glucose homeostasis, or metabolic parameters in subjects with T1D. The findings from this preliminary RCT do not support the use of therapeutic n-3PUFA supplementation in the treatment and management of T1D and its associated complications. Trial Registration ISRCTN, ISRCTN40811115. Registered 27 June 2017, http://www.isrctn.com/ISRCTN40811115 .",2020,"Total exposure to n-3PUFA over the 6-months (area under the curve) was 14.27 ± 3.05% per month under n-3PUFA, and 9.11 ± 2.74% per month under PLA (P < 0.001).","['subjects with T1D.\nMETHODS\n\n\nTwenty-seven adults with T1D', 'subjects with T1D', 'people with type 1 diabetes', 'Twenty subjects completed the trial in full']","['daily high-dose-bolus n-3PUFA supplementation', 'Omega-3 polyunsaturated fatty acid supplementation versus placebo', 'encapsulated n-3PUFA or encapsulated 3.0\xa0g/day corn oil placebo (PLA', 'omega-3 polyunsaturated fatty acids (n-3PUFA', 'n-3PUFA', 'n-3PUFA supplementation', 'placebo']","['mean\u2009±\u2009SD baseline n-3PUFA index', 'Erythrocyte fatty acid composition', 'VCAM-1, ICAM-1, E-selectin, P-selectin, pentraxin-3, VEGF, TNFα, CIMT, FMD, blood pressure, HbA1c, FPG, and postprandial metabolism', 'inflammation-associated endothelial biomarkers (vascular cell adhesion molecule-1 [VCAM-1], intercellular adhesion molecule-1 [ICAM-1], E-selectin, P-selectin, pentraxin-3, vascular endothelial growth factor [VEGF]), and their mediator tumor necrosis factor alpha [TNFα] analysed via immunoassay, vascular structure (carotid intima-media thickness [CIMT]) and function (brachial artery flow mediated dilation [FMD]) determined via ultrasound technique, blood pressure, glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), and postprandial metabolism', 'vascular health, glycaemic control, and metabolic parameters', 'vascular health, glucose homeostasis, or metabolic parameters', 'Total exposure to n-3PUFA']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0010029', 'cui_str': 'Corn Oil'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}, {'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0134835', 'cui_str': 'Lymphocyte antigen CD62'}, {'cui': 'C0174234', 'cui_str': 'PTX3 protein'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",27.0,0.559798,"Total exposure to n-3PUFA over the 6-months (area under the curve) was 14.27 ± 3.05% per month under n-3PUFA, and 9.11 ± 2.74% per month under PLA (P < 0.001).","[{'ForeName': 'Lauren L', 'Initials': 'LL', 'LastName': ""O'Mahoney"", 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Dunseath', 'Affiliation': 'Diabetes Research Group, Swansea University Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Churm', 'Affiliation': 'Applied Sports, Technology, Exercise and Medicine (A-STEM) Research Centre, Swansea University, Swansea, UK.'}, {'ForeName': 'Mel', 'Initials': 'M', 'LastName': 'Holmes', 'Affiliation': 'School of Food Science and Nutrition, Faculty of Environment, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Boesch', 'Affiliation': 'School of Food Science and Nutrition, Faculty of Environment, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Stavropoulos-Kalinoglou', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, UK.'}, {'ForeName': 'Ramzi A', 'Initials': 'RA', 'LastName': 'Ajjan', 'Affiliation': 'Leeds Institute of Cardiovascular and Metabolic Medicine, Faculty of Medicine and Health, University of Leeds, Leeds, UK.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Birch', 'Affiliation': 'School of Biomedical Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Orsi', 'Affiliation': ""Leeds Institute of Medical Research at St James's, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Mappa', 'Affiliation': ""Leeds Institute of Medical Research at St James's, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Oliver J', 'Initials': 'OJ', 'LastName': 'Price', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, UK.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Campbell', 'Affiliation': 'School of Food Science and Nutrition, Faculty of Environment, University of Leeds, Leeds, LS2 9JT, UK. m.d.campbell@leeds.ac.uk.'}]",Cardiovascular diabetology,['10.1186/s12933-020-01094-5']
1972,32787892,"Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials.","BACKGROUND


In cluster randomized crossover (CRXO) trials, groups of participants (i.e., clusters) are randomly allocated to receive a sequence of interventions over time (i.e., cluster periods). CRXO trials are becoming more comment when they are feasible, as they require fewer clusters than parallel group cluster randomized trials. However, CRXO trials have not been frequently used in orthopedic fracture trials and represent a novel methodological application within the field. To disseminate the early knowledge gained from our experience initiating two cluster randomized crossover trials, we describe our process for the identification and selection of the orthopedic practices (i.e., clusters) participating in the PREP-IT program and present data to describe their key characteristics.
METHODS


The PREP-IT program comprises two ongoing pragmatic cluster randomized crossover trials (Aqueous-PREP and PREPARE) which compare the effect of iodophor versus chlorhexidine solutions on surgical site infection and unplanned fracture-related reoperations in patients undergoing operative fracture management. We describe the process we used to identify and select orthopedic practices (clusters) for the PREP-IT trials, along with their characteristics.
RESULTS


We identified 58 potential orthopedic practices for inclusion in the PREP-IT trials. After screening each practice for eligibility, we selected 30 practices for participation and randomized each to a sequence of interventions (15 for Aqueous-PREP and 20 for PREPARE). The majority of orthopedic practices included in the Aqueous-PREP and PREPARE trials were situated in level I trauma centers (100% and 87%, respectively). Orthopedic practices in the Aqueous-PREP trial operatively treated a median of 149 open fracture patients per year, included a median of 11 orthopedic surgeons, and had access to a median of 5 infection preventionists. Orthopedic practices in the PREPARE trial treated a median of 142 open fracture and 1090 closed fracture patients per year, included a median of 7.5 orthopedic surgeons, and had access to a median of 6 infection preventionists.
CONCLUSIONS


The PREP-IT trials provide an example of how to follow the reporting standards for cluster randomized crossover trials by providing a clear definition of the cluster unit, a thorough description of the cluster identification and selection process, and sufficient description of key cluster characteristics.
TRIAL REGISTRATION


Both trials are registered at ClinicalTrials.gov (A-PREP: NCT03385304 December 28, 2017, and PREPARE: NCT03523962 May 14, 2018).",2020,"Orthopedic practices in the PREPARE trial treated a median of 142 open fracture and 1090 closed fracture patients per year, included a median of 7.5 orthopedic surgeons, and had access to a median of 6 infection preventionists.
","['149 open fracture patients per year, included a median of 11 orthopedic surgeons, and had access to a median of 5 infection preventionists', '58 potential orthopedic practices for inclusion in the PREP-IT trials', 'patients undergoing operative fracture management', 'groups of participants (i.e., clusters', '142 open fracture and 1090 closed fracture patients per year, included a median of 7.5 orthopedic surgeons, and had access to a median of 6 infection preventionists']",['iodophor versus chlorhexidine solutions'],[],"[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0016662', 'cui_str': 'Fracture, open'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1160964', 'cui_str': 'Fracture care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0016659', 'cui_str': 'Fracture, closed'}, {'cui': 'C4517859', 'cui_str': '7.5'}]","[{'cui': 'C0021988', 'cui_str': 'Iodophors'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]",[],2.0,0.363304,"Orthopedic practices in the PREPARE trial treated a median of 142 open fracture and 1090 closed fracture patients per year, included a median of 7.5 orthopedic surgeons, and had access to a median of 6 infection preventionists.
","[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Department of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada. sprags@mcmaster.ca.'}, {'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Scott', 'Affiliation': 'Department of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Dodds', 'Affiliation': 'Department of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pogorzelski', 'Affiliation': 'Department of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'McKay', 'Affiliation': 'Department of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada.'}, {'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Harris', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Wood', 'Affiliation': 'Association of periOperative Registered Nurses, Denver, CO, USA.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, 293 Wellington St. N., Suite 110, Hamilton, ON, L8L 8E7, Canada.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Department of Surgery, Division of Orthopaedic Surgery, McMaster University, 293 Wellington Street North, Suite 110, Hamilton, ON, L8L 8E7, Canada.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Department of Orthopaedic Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Gaski', 'Affiliation': 'Department of Orthopaedic Surgery, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Boulton', 'Affiliation': 'Department of Orthopaedics, Banner Health and the University of Arizona-Tucson, Tucson, AZ, USA.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Marcano-Fernández', 'Affiliation': ""Orthopedic Department, Parc Taulí Hospital Universitari, Institut d'Investigació i Innovació Parc Taulí I3PT, Universitat Autònoma de Barcelona, Sabadell, Spain.""}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Guerra-Farfán', 'Affiliation': ""Department of Orthopaedic Surgery and Traumatology, University Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Hebden', 'Affiliation': 'Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lyndsay M', 'Initials': 'LM', 'LastName': ""O'Hara"", 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Slobogean', 'Affiliation': 'Department of Orthopaedics, University of Maryland, R Adams Cowley Shock Trauma Center, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04611-9']
1973,32787893,"Effects of ""Thursdays at the Museum"" at the Montreal Museum of Fine Arts on the mental and physical health of older community dwellers: the art-health randomized clinical trial protocol.","BACKGROUND


Recently, we demonstrated that the Montreal Museum of Fine Arts' (MMFA) participatory art-based activity, known as ""Thursdays at the Museum,"" improved the well-being, quality of life, and physical health (i.e., frailty) of older community dwellers by using a pre-post intervention, single arm, prospective and longitudinal experimental design. The present randomized clinical trial (RCT), known as the Art-Health RCT (A-Health RCT), aims to compare changes in well-being, quality of life, frailty, and physiological measures in older community dwellers who participate in ""Thursdays at the Museum"" (intervention group) and in their counterparts who do not participate in this art-based activity (control group).
METHODS/DESIGN


The current unicenter, randomized, clinical, controlled, comparative trial recruits 150 older community dwellers to two parallel arms (75 participants in the intervention group and 75 participants in the control group). The intervention is a 3-month cycle of weekly ""Thursdays at the Museum,"" which are structured 2-h-long art-based workshops performed in a group setting at the MMFA. The control group is composed of participants who do not take part in art-based activities, receive their usual health and/or social services, and commit to report any other activity practiced during the same time. Assessments of the primary outcome (well-being) and the secondary outcomes (quality of life, frailty, and physiological measures including heart rate, daily step count, sleep duration, and its phases) are performed on six occasions: at baseline, at the beginning of the second and third months, at the end of the third month, as well as 6 and 12 months after the last workshop. Statistical analyses are performed with the intention to treat and per protocol. Comparisons of changes in outcome measures between intervention and control groups use repeated measures tests.
DISCUSSION


Art-based activities carried out at museums have been receiving increased interest from researchers and policy-makers because of their benefits to mental and physical health. There are few robust studies, such as RCTs, that focus on older community dwellers or assess the efficacy of these participatory museum activities. The A-Health RCT study provides an opportunity to confirm the benefits of a participatory art-based museum activity on the elderly population and to show the key role played by museums in public health promotion.
TRIAL REGISTRATION


NCT03679715 ; Title: A-Health RCT: Effects of Participatory Art-Based Activity on Health of Older Community Dwellers; First posted date: September 20, 2018; prospectively registered.",2020,"Assessments of the primary outcome (well-being) and the secondary outcomes (quality of life, frailty, and physiological measures including heart rate, daily step count, sleep duration, and its phases) are performed on six occasions: at baseline, at the beginning of the second and third months, at the end of the third month, as well as 6 and 12 months after the last workshop.","['Older Community Dwellers', 'older community dwellers', 'older community dwellers who participate in ""Thursdays at the Museum"" (intervention group) and in their counterparts who do not participate in this art-based activity (control group', '150 older community dwellers to two parallel arms (75 participants in the intervention group and 75 participants in the control group']",['Participatory Art-Based Activity'],"['secondary outcomes (quality of life, frailty, and physiological measures including heart rate, daily step count, sleep duration, and its phases']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0585028', 'cui_str': 'Thursday'}, {'cui': 'C0026863', 'cui_str': 'Museum'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",150.0,0.047586,"Assessments of the primary outcome (well-being) and the secondary outcomes (quality of life, frailty, and physiological measures including heart rate, daily step count, sleep duration, and its phases) are performed on six occasions: at baseline, at the beginning of the second and third months, at the end of the third month, as well as 6 and 12 months after the last workshop.","[{'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Beauchet', 'Affiliation': 'Department of Medicine, Division of Geriatric Medicine, Sir Mortimer B. Davis Jewish General Hospital and Lady Davis Institute for Medical Research, McGill University, 3755 chemin de la Côte-Sainte-Catherine, Montréal, Quebec, H3T 1E2, Canada. olivier.beauchet@mcgill.ca.'}, {'ForeName': 'Liam', 'Initials': 'L', 'LastName': 'Cooper-Brown', 'Affiliation': 'Centre of Excellence on Longevity of the McGill Integrated University Health Network, Montreal, Quebec, Canada.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Hayashi', 'Affiliation': 'Faculty of Informatics for Arts Department of Information Expression, Shobi University, Kawagoe, Japan.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Galery', 'Affiliation': 'Centre of Excellence on Longevity of the McGill Integrated University Health Network, Montreal, Quebec, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Vilcocq', 'Affiliation': 'Centre of Excellence on Longevity of the McGill Integrated University Health Network, Montreal, Quebec, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bastien', 'Affiliation': 'Education and Wellness Department of the Montreal Museum of Fine Arts, Montreal, Quebec, Canada.'}]",Trials,['10.1186/s13063-020-04625-3']
1974,32787896,The effect of a telerehabilitation virtual reality intervention on functional upper limb activities in people with multiple sclerosis: a study protocol for the TEAMS pilot randomized controlled trial.,"BACKGROUND


Approximately 60% of people with multiple sclerosis (PwMS) suffer from upper limb dysfunction. Our primary goal is to implement a single-blind, randomized control trial (RCT) designed to compare the effectiveness of an 8-week home-based telerehab virtual reality (VR) program with conventional therapy in PwMS with manual dexterity difficulties. Secondary aims include (a) evaluating the impact of the programs on quality of life after the intervention and a follow-up 1 month later and (b) evaluating the impact of the programs on adherence and satisfaction.
METHODS


Twenty-four PwMS will be recruited to the study which will be conducted at two established MS centers: (1) The Regional Center for Diagnosis and Treatment of Multiple Sclerosis, Binaghi Hospital, Cagliari, Italy, and (2) The Multiple Sclerosis Center, Sheba Medical Center, Tel-Hashomer, Israel. Participants will complete a total of three assessments focusing on upper limb functions. Both groups will receive 16 training sessions focusing on functional upper limb activities. The home-based telerehab VR intervention will comprise a custom-made software program running on a private computer or laptop. PwMS will perform several activities of daily living (ADL) functions associated with self-care, dressing, and meal preparation. Conventional therapy will focus on task-related upper-limb treatments while in a sitting position, indicative of the standard care in MS. Following 8 weeks of training, participants will complete a further outcome assessment. The same tests will be conducted 1 month (as a follow-up) after completion of the intervention.
DISCUSSION


The outcomes of this study have tremendous potential to improve the quality of evidence and informed decisions of functional upper limb activities in PwMS. If comparable results are found between the treatments in improving upper limb outcomes, this would suggest that PwMS can choose the program that best meets their personal needs, e.g., financial concerns, transportation, or accessibility issues. Secondly, this information can be used by healthcare providers and medical professionals in developing upper limb exercise programs that will most likely succeed in PwMS.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04032431 . Registered on 19 July 2019.",2020,The home-based telerehab VR intervention will comprise a custom-made software program running on a private computer or laptop.,"['people with multiple sclerosis', 'people with multiple sclerosis (PwMS) suffer from upper limb dysfunction', 'Twenty-four PwMS will be recruited to the study which will be conducted at two established MS centers: (1) The Regional Center for Diagnosis and Treatment of Multiple Sclerosis, Binaghi Hospital, Cagliari, Italy, and (2', 'PwMS with manual dexterity difficulties']","['telerehabilitation virtual reality intervention', '8-week home-based telerehab virtual reality (VR) program with conventional therapy', 'Conventional therapy']","['quality of life', 'functional upper limb activities', 'adherence and satisfaction']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0558281', 'cui_str': 'Regional center'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]","[{'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0579116', 'cui_str': 'Upper limb activities'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0392797,The home-based telerehab VR intervention will comprise a custom-made software program running on a private computer or laptop.,"[{'ForeName': 'Alon', 'Initials': 'A', 'LastName': 'Kalron', 'Affiliation': 'Department of Physical Therapy, School of Health Professions, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. alonkalr@post.tau.ac.il.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Achiron', 'Affiliation': 'Multiple Sclerosis Center, Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Pau', 'Affiliation': 'Department of Mechanical, Chemical and Materials Engineering, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Cocco', 'Affiliation': 'Multiple Sclerosis Center, Binaghi Hospital, Department of Medical Science and Public Health, University of Cagliari, Cagliari, Italy.'}]",Trials,['10.1186/s13063-020-04650-2']
1975,32788120,Impact of implementation of an individualised thromboprophylaxis protocol in critically ill ICU patients with COVID-19: A longitudinal controlled before-after study.,"INTRODUCTION


An individualised thromboprophylaxis was implemented in critically ill patients suffering from coronavirus disease 2019 (COVID-19) pneumonia to reduce mortality and improve clinical outcome. The aim of this study was to evaluate the effect of this intervention on clinical outcome.
METHODS


In this mono-centric, controlled, before-after study, all consecutive adult patients with confirmed COVID-19 pneumonia admitted to ICU from March 13th to April 20th 2020 were included. A thromboprophylaxis protocol, including augmented LMWH dosing, individually tailored with anti-Xa measurements and twice-weekly ultrasonography screening for DVT, was implemented on March 31th 2020. Primary endpoint is one-month mortality. Secondary outcomes include two-week and three-week mortality, the incidence of VTE, acute kidney injury and continuous renal replacement therapy (CRRT). Multiple regression modelling was used to correct for differences between the two groups.
RESULTS


46 patients were included in the before group, 26 patients in the after group. One month mortality decreased from 39.13% to 3.85% (p < 0.001). After correction for confounding variables, one-month mortality was significantly higher in the before group (p = 0.02, OR 8.86 (1.46, 53.75)). The cumulative incidence of VTE and CRRT was respectively 41% and 30.4% in the before group and dropped to 15% (p = 0.03) and 3.8% (p = 0.01), respectively. After correction for confounding variables, risk of VTE (p = 0.03, 6.01 (1.13, 32.12)) and CRRT (p = 0.02, OR 19.21 (1.44, 255.86)) remained significantly higher in the before group.
CONCLUSION


Mortality, cumulative risk of VTE and need for CRRT may be significantly reduced in COVID-19 patients by implementation of a more aggressive thromboprophylaxis protocol. Future research should focus on confirmation of these results in a randomized design and on uncovering the mechanisms underlying these observations.
REGISTRATION NUMBER


NCT04394000.",2020,"After correction for confounding variables, one-month mortality was significantly higher in the before group (p = 0.02, OR 8.86 (1.46, 53.75)).","['critically ill ICU patients with COVID-19', 'critically ill patients suffering from coronavirus disease 2019 (COVID-19) pneumonia', '46 patients were included in the before group, 26 patients in the after group', 'consecutive adult patients with confirmed COVID-19 pneumonia admitted to ICU from March 13th to April 20th 2020 were included']","['LMWH dosing, individually tailored with anti-Xa measurements and twice-weekly ultrasonography screening for DVT', 'individualised thromboprophylaxis protocol']","['week mortality, the incidence of VTE, acute kidney injury and continuous renal replacement therapy (CRRT', 'mortality', 'month mortality', 'cumulative incidence of VTE and CRRT', 'Mortality, cumulative risk of VTE and need for CRRT', 'CRRT']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}]",46.0,0.053393,"After correction for confounding variables, one-month mortality was significantly higher in the before group (p = 0.02, OR 8.86 (1.46, 53.75)).","[{'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Stessel', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium; UHasselt, Faculty of Medicine and Life Sciences, LCRC, Agoralaan, 3590 Diepenbeek, Belgium. Electronic address: bjorn.stessel@jessazh.be.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Vanvuchelen', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Bruckers', 'Affiliation': 'I-BioStat, Data Science Institute, Hasselt University, Martelarenlaan 42, 3500 Hasselt, Belgium.'}, {'ForeName': 'Laurien', 'Initials': 'L', 'LastName': 'Geebelen', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Ina', 'Initials': 'I', 'LastName': 'Callebaut', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium; UHasselt, Faculty of Medicine and Life Sciences, LCRC, Agoralaan, 3590 Diepenbeek, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Vandenbrande', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Pellens', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Van Tornout', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Ory', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Karlijn', 'Initials': 'K', 'LastName': 'van Halem', 'Affiliation': 'Department of Infectious Diseases and Immunity, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Messiaen', 'Affiliation': 'UHasselt, Faculty of Medicine and Life Sciences, LCRC, Agoralaan, 3590 Diepenbeek, Belgium; Department of Infectious Diseases and Immunity, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Lieven', 'Initials': 'L', 'LastName': 'Herbots', 'Affiliation': 'Department of Cardiology and Coronary Care Unit, Jessa Hospital, Hasselt, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Ramaekers', 'Affiliation': 'Chief Medical Officer, Jessa Hospital, Hasselt, Belgium; Leuven Institute for Healthcare Policy (LIHP), University of Leuven, Belgium.'}, {'ForeName': 'Jasperina', 'Initials': 'J', 'LastName': 'Dubois', 'Affiliation': 'Department of Intensive Care and Anesthesiology, Jessa Hospital, Hasselt, Belgium.'}]",Thrombosis research,['10.1016/j.thromres.2020.07.038']
1976,32789031,Comparison of General Anesthesia (Sevoflurane) and Spinal Anesthesia (Levobupivacaine) Methods on QT Dispersion in Inguinal Hernia Operations.,"Introduction Arrhythmias are one of the most frequently seen issues during surgical operations. In this study, we investigated and compared the effects on the QT dispersion of patients when using a method of volatile inhalation mask anesthesia with sevoflurane (VIMA: Group I) and when spinal anesthesia was performed with levobupivacaine (Group II). Methods The study included 40 patients who had American Society of Anesthesiology scores of I-II (ASA I-II), were aged from 18 to 65 years, and were scheduled for inguinal hernia operations. Approval of the university ethics committee was obtained before the study began. All patients had measurements taken for non-invasive blood pressure, including systolic arterial pressure (SAP), diastolic arterial pressure (DAP), and mean arterial pressure (MAP), heart rate (HR), and oxygen saturation (SO 2 ) values. The QT intervals were measured using the 12-derivation electrocardiogram (ECG) device (Cardiofax V). Our study was performed with randomization using the closed envelope method. Results When the percentage differences of the HR values from the initial period in both groups were compared, we observed significant differences between the groups, with increases in the VIMA group at the second period as well as increases in the VIMA group at the fourth, fifth, sixth, seventh, and ninth periods but decreases in the spinal anesthesia group for these periods. There were statistically significant differences between the two groups at the third and fifth periods when the percentage differences of the QTc values from the initial period were compared. We observed increases in the spinal anesthesia group. Conclusion In our study, we suggest that the tendency toward arrhythmia may be reduced by choosing general anesthesia with sevoflurane rather than levobupivacaine in patients with cardiac complaints who are undergoing regional anesthesia and/or taking medication that affects QT intervals.",2020,There were statistically significant differences between the two groups at the third and fifth periods when the percentage differences of the QTc values from the initial period were compared.,"['40 patients who had American Society of Anesthesiology scores of I-II (ASA I-II), were aged from 18 to 65 years, and were scheduled for inguinal hernia operations', 'patients with cardiac complaints who are undergoing regional anesthesia and/or taking medication that affects QT intervals', 'Inguinal Hernia Operations']","['sevoflurane', 'levobupivacaine', 'General Anesthesia (Sevoflurane) and Spinal Anesthesia (Levobupivacaine', 'spinal anesthesia', 'volatile inhalation mask anesthesia with sevoflurane (VIMA']","['12-derivation electrocardiogram (ECG) device (Cardiofax V', 'QTc values', 'non-invasive blood pressure, including systolic arterial pressure (SAP), diastolic arterial pressure (DAP), and mean arterial pressure (MAP), heart rate (HR), and oxygen saturation (SO 2 ) values', 'HR values']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]","[{'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0443769', 'cui_str': 'Volatile agent'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0181751', 'cui_str': 'Anesthesia mask'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4301970', 'cui_str': 'Non-invasive blood pressure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",40.0,0.0365324,There were statistically significant differences between the two groups at the third and fifth periods when the percentage differences of the QTc values from the initial period were compared.,"[{'ForeName': 'Basak', 'Initials': 'B', 'LastName': 'Pehlivan', 'Affiliation': 'Anesthesiology, Harran University, Sanliurfa, TUR.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Akçay', 'Affiliation': 'Anesthesiology and Reanimation, Ankara Numune Training and Research Hospital, Anesthesiology and Reanimation Clinic, Ankara, TUR.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Atlas', 'Affiliation': 'Anesthesiology, Harran University, Sanliurfa, TUR.'}, {'ForeName': 'Mehmet K', 'Initials': 'MK', 'LastName': 'Erol', 'Affiliation': 'Anesthesiology, Harran University, Sanliurfa, TUR.'}, {'ForeName': 'Erdogan', 'Initials': 'E', 'LastName': 'Duran', 'Affiliation': 'Anesthesiology and Reanimation, Harran University, Sanliurfa, TUR.'}, {'ForeName': 'Mahmut A', 'Initials': 'MA', 'LastName': 'Karahan', 'Affiliation': 'Anesthesiology and Critical Care, Harran University, Sanliurfa, TUR.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Binici', 'Affiliation': 'Anesthesiology and Critical Care, Harran University, Sanliurfa, TUR.'}, {'ForeName': 'Evren', 'Initials': 'E', 'LastName': 'Büyükfırat', 'Affiliation': 'Anesthesiology and Critical Care, Harran University, Sanliurfa, TUR.'}, {'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Altay', 'Affiliation': 'Anesthesiology and Critical Care, Harran University, Sanliurfa, TUR.'}]",Cureus,['10.7759/cureus.9079']
1977,32789117,Utility of an educational video on epinephrine prefilled syringe usage for anaphylaxis: a randomized control trial.,"Background


Anaphylaxis is a serious allergic reaction that needs early administration of intramuscular epinephrine for treatment. Currently, structured education on epinephrine prefilled syringe usage for anaphylaxis does not exist.
Objective


This study aimed to examine the effectiveness of the epinephrine prefilled syringe usage video, compared with routine teaching method.
Methods


This was a randomized controlled trial. A total of 129 medical students were assigned either to the routine teaching group or the video teaching group. The main outcome is the total number of medical students who passed (>70%) the test. The pre-, posttest, and objective structured clinical examination (OSCE) were used to evaluate the students.
Results


At the 2-week follow-up, the individual scores increased significantly after both interventions ( p  < 0.001). The percentages of medical students who passed the exam in the pre-, posttests, and OSCE were not significantly different between the groups. In the routine teaching group and video teaching group, the percentages of students who passed increased from 32.2% to 96.6% and 28.1% to 95.3%, respectively ( p  = 0.99). Using univariate logistic regression analysis, previous knowledge of anaphylaxis was a factor to pass the test (odds ratio, 5.07; 95% confidence interval, 1.93-13.31;  p  < 0.01).
Conclusion


The study demonstrated that the scores after the video education intervention were not inferior to the routine teaching group. This technique might be applied for patients in clinical practice. However, the further researches in general population are needed to confirm the efficacy of this method.",2020,"At the 2-week follow-up, the individual scores increased significantly after both interventions ( p  < 0.001).","['anaphylaxis', '129 medical students']","['educational video', 'epinephrine prefilled syringe usage video', 'routine teaching group or the video teaching group', 'epinephrine']","['individual scores', 'total number of medical students', 'objective structured clinical examination (OSCE']","[{'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",129.0,0.0745177,"At the 2-week follow-up, the individual scores increased significantly after both interventions ( p  < 0.001).","[{'ForeName': 'Araya', 'Initials': 'A', 'LastName': 'Yuenyongviwat', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Thatchai', 'Initials': 'T', 'LastName': 'Wirodwanich', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Wipa', 'Initials': 'W', 'LastName': 'Jessadapakorn', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Pasuree', 'Initials': 'P', 'LastName': 'Sangsupawanich', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}]",Asia Pacific allergy,['10.5415/apallergy.2020.10.e32']
1978,32789211,Effects of a Cooking Program Based on Brain-activating Rehabilitation for Elderly Residents with Dementia in a  Roken  Facility: A Randomized Controlled Trial.,"Objective


Rehabilitation for dementia is important in  Roken  Geriatric Health Service Facilities in Japan. This study evaluated the effects of a cooking program as rehabilitation for elderly residents with dementia.
Methods


We carried out a 12-week cooking program based on the five principles of brain-activating rehabilitation (BAR): fostering a pleasant atmosphere, interactive communication, establishing social roles, giving and receiving praise, and errorless learning. The program was carried out in small groups and consisted of 90-min classes once a week. Participants were 36 elderly residents with dementia (mean 85.4 ± 6.5 years) who were randomly divided into intervention (n = 18) and control (n = 18) groups. The control group participated in recreation and both groups received individual conventional rehabilitation twice a week for 30 min. The effects of intervention were evaluated using nine outcome measures.
Results


A total of 29 participants were included in the analysis (two-way analysis of variance). The attendance rate was 86.6% in the intervention group (n = 13). The Yamaguchi  Kanji  Symbol Substitution Test (executive function) showed significant interaction (F(1, 27) = 4.305, P = 0.048) between the two groups: the control group (n = 16) showed significant deterioration (pre 4.9 ± 5.6 to post 3.0 ± 4.9; P = 0.032). The dementia behavior disturbance scale also showed significant interaction (F(1, 29) = 13.298, P = 0.001): the intervention group (n = 16) showed significant improvement (pre 21.6 ± 12.2 to post 11.4 ± 11.5; P < 0.001). No significant differences were observed in the other outcome measures.
Conclusions


Our findings suggest that a cooking program based on BAR can reduce the behavioral and psychological symptoms of dementia and maintain executive function.",2017,the intervention group (n = 16) showed significant improvement (pre 21.6 ± 12.2 to post 11.4 ± 11.5; P < 0.001).,"['Roken  Geriatric Health Service Facilities in Japan', 'Participants were 36 elderly residents with dementia (mean 85.4 ± 6.5 years', 'Elderly Residents with Dementia in a  Roken  Facility', 'elderly residents with dementia', 'A total of 29 participants']","['individual conventional rehabilitation', 'Cooking Program Based on Brain-activating Rehabilitation', 'brain-activating rehabilitation (BAR): fostering a pleasant atmosphere, interactive communication, establishing social roles, giving and receiving praise, and errorless learning', 'cooking program']","['attendance rate', 'behavioral and psychological symptoms of dementia and maintain executive function', 'dementia behavior disturbance scale']","[{'cui': 'C0018753', 'cui_str': 'Health Services for Aged'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0910435', 'cui_str': 'AM 36'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0004178', 'cui_str': 'Atmosphere'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0557963', 'cui_str': 'Praising'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C4285807', 'cui_str': 'Behavioral and psychological symptoms of dementia'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",29.0,0.0189147,the intervention group (n = 16) showed significant improvement (pre 21.6 ± 12.2 to post 11.4 ± 11.5; P < 0.001).,"[{'ForeName': 'Tatsuhiko', 'Initials': 'T', 'LastName': 'Murai', 'Affiliation': 'Gunma University Graduate School of Health Sciences, Maebashi, Gunma, Japan.'}, {'ForeName': 'Haruyasu', 'Initials': 'H', 'LastName': 'Yamaguchi', 'Affiliation': 'Gunma University Graduate School of Health Sciences, Maebashi, Gunma, Japan.'}]",Progress in rehabilitation medicine,['10.2490/prm.20170004']
1979,32789480,Effect of Adjuvant Paclitaxel and Carboplatin on Survival in Women With Triple-Negative Breast Cancer: A Phase 3 Randomized Clinical Trial.,"Importance


The value of platinum-based adjuvant chemotherapy in patients with triple-negative breast cancer (TNBC) remains controversial, as does whether BRCA1 and BRCA2 (BRCA1/2) germline variants are associated with platinum treatment sensitivity.
Objective


To compare 6 cycles of paclitaxel plus carboplatin (PCb) with a standard-dose regimen of 3 cycles of cyclophosphamide, epirubicin, and fluorouracil followed by 3 cycles of docetaxel (CEF-T).
Design, Setting, and Participants


This phase 3 randomized clinical trial was conducted at 9 cancer centers and hospitals in China. Between July 1, 2011, and April 30, 2016, women aged 18 to 70 years with operable TNBC after definitive surgery (having pathologically confirmed regional node-positive disease or node-negative disease with tumor diameter >10 mm) were screened and enrolled. Exclusion criteria included having metastatic or locally advanced disease, having non-TNBC, or receiving preoperative anticancer therapy. Data were analyzed from December 1, 2019, to January 31, 2020, from the intent-to-treat population as prespecified in the protocol.
Interventions


Participants were randomized to receive PCb (paclitaxel 80 mg/m2 and carboplatin [area under the curve = 2] on days 1, 8, and 15 every 28 days for 6 cycles) or CEF-T (cyclophosphamide 500 mg/m2, epirubicin 100 mg/m2, and fluorouracil 500 mg/m2 every 3 weeks for 3 cycles followed by docetaxel 100 mg/m2 every 3 weeks for 3 cycles).
Main Outcomes and Measures


The primary end point was disease-free survival (DFS). Secondary end points included overall survival, distant DFS, relapse-free survival, DFS in patients with germline variants in BRCA1/2 or homologous recombination repair (HRR)-related genes, and toxicity.
Results


A total of 647 patients (mean [SD] age, 51 [44-57] years) with operable TNBC were randomized to receive CEF-T (n = 322) or PCb (n = 325). At a median follow-up of 62 months, DFS time was longer in those assigned to PCb compared with CEF-T (5-year DFS, 86.5% vs 80.3%, hazard ratio [HR] = 0.65; 95% CI, 0.44-0.96; P = .03). Similar outcomes were observed for distant DFS and relapse-free survival. There was no statistically significant difference in overall survival between the groups (HR = 0.71; 95% CI, 0.42-1.22, P = .22). In the exploratory and hypothesis-generating subgroup analyses of PCb vs CEF-T, the HR for DFS was 0.44 (95% CI, 0.15-1.31; P = .14) in patients with the BRCA1/2 variant and 0.39 (95% CI, 0.15-0.99; P = .04) in those with the HRR variant. Safety data were consistent with the known safety profiles of relevant drugs.
Conclusions and Relevance


These findings suggest that a paclitaxel-plus-carboplatin regimen is an effective alternative adjuvant chemotherapy choice for patients with operable TNBC. In the era of molecular classification, subsets of TNBC sensitive to PCb should be further investigated.
Trial Registration


ClinicalTrials.gov Identifier: NCT01216111.",2020,"At a median follow-up of 62 months, DFS time was longer in those assigned to PCb compared with CEF-T (5-year DFS, 86.5% vs 80.3%, hazard ratio [HR] = 0.65; 95% CI, 0.44-0.96; P = .03).","['patients with triple-negative breast cancer (TNBC', '647 patients (mean [SD] age, 51 [44-57] years) with operable TNBC', '9 cancer centers and hospitals in China', 'Between July 1, 2011, and April 30, 2016, women aged 18 to 70 years with operable TNBC after definitive surgery (having pathologically confirmed regional node-positive disease or node-negative disease with tumor diameter >10 mm) were screened and enrolled', 'patients with operable TNBC', 'Exclusion criteria included having metastatic or locally advanced disease, having non-TNBC, or receiving preoperative anticancer therapy', 'Women With Triple-Negative Breast Cancer']","['docetaxel', 'CEF-T', 'paclitaxel-plus-carboplatin regimen', 'PCb', 'platinum-based adjuvant chemotherapy', 'CEF-T (cyclophosphamide 500 mg/m2, epirubicin 100 mg/m2, and fluorouracil', 'PCb (paclitaxel 80 mg/m2 and carboplatin', 'Adjuvant Paclitaxel and Carboplatin', 'paclitaxel plus carboplatin (PCb', 'cyclophosphamide, epirubicin, and fluorouracil followed by 3 cycles of docetaxel (CEF-T']","['overall survival, distant DFS, relapse-free survival, DFS in patients with germline variants in BRCA1/2 or homologous recombination repair (HRR)-related genes, and toxicity', 'DFS time', 'overall survival', 'Survival', 'distant DFS and relapse-free survival', 'disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205188', 'cui_str': 'Operable'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C4080545', 'cui_str': 'Cyclophosphamide 500 MG'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C1158513', 'cui_str': 'Recombinational Repair of DNA'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",647.0,0.405234,"At a median follow-up of 62 months, DFS time was longer in those assigned to PCb compared with CEF-T (5-year DFS, 86.5% vs 80.3%, hazard ratio [HR] = 0.65; 95% CI, 0.44-0.96; P = .03).","[{'ForeName': 'Ke-Da', 'Initials': 'KD', 'LastName': 'Yu', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Fu-Gui', 'Initials': 'FG', 'LastName': 'Ye', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'He', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Mo', 'Affiliation': 'Department of Cancer Prevention & Clinical Statistics Center, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Guang-Yu', 'Initials': 'GY', 'LastName': 'Liu', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Gen-Hong', 'Initials': 'GH', 'LastName': 'Di', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xiao-Hua', 'Initials': 'XH', 'LastName': 'Zeng', 'Affiliation': 'Breast Center, Chongqing Cancer Hospital, Chongqing University, Chongqing, China.'}, {'ForeName': 'Ping-Qing', 'Initials': 'PQ', 'LastName': 'He', 'Affiliation': ""Department of Breast Surgery, Shanghai Sixth People's Hospital, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Ke-Jin', 'Initials': 'KJ', 'LastName': 'Wu', 'Affiliation': 'Department of Breast Surgery, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Yi-Feng', 'Initials': 'YF', 'LastName': 'Hou', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Breast Surgery, The International Peace Maternity & Child Health Hospital of China Welfare Institute, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Breast Surgery, Shanghai Ninth People's Hospital Huangpu Branch, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Zhi-Gang', 'Initials': 'ZG', 'LastName': 'Zhuang', 'Affiliation': 'Department of Breast Surgery, Shanghai First Maternity and Infant Hospital, Shanghai Tongji University, Shanghai, China.'}, {'ForeName': 'Chuan-Gui', 'Initials': 'CG', 'LastName': 'Song', 'Affiliation': 'Department of Breast Surgery, Fujian Medical University Union Hospital, Fuzhou, China.'}, {'ForeName': 'Xiao-Yan', 'Initials': 'XY', 'LastName': 'Lin', 'Affiliation': 'Department of Breast Surgery, Tongji University School of Medicine Yangpu Hospital, Shanghai, China.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Toss', 'Affiliation': 'Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Ricci', 'Affiliation': 'Department of Drug Development and Innovation, Institute Curie, Paris & Saint-Cloud, France.'}, {'ForeName': 'Zhen-Zhou', 'Initials': 'ZZ', 'LastName': 'Shen', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhi-Ming', 'Initials': 'ZM', 'LastName': 'Shao', 'Affiliation': 'Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",JAMA oncology,['10.1001/jamaoncol.2020.2965']
1980,32789505,Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes: Interim Analysis of 2 Randomized Clinical Trials.,"Importance


A vaccine against coronavirus disease 2019 (COVID-19) is urgently needed.
Objective


To evaluate the safety and immunogenicity of an investigational inactivated whole-virus COVID-19 vaccine in China.
Interventions


In the phase 1 trial, 96 participants were assigned to 1 of the 3 dose groups (2.5, 5, and 10 μg/dose) and an aluminum hydroxide (alum) adjuvant-only group (n = 24 in each group), and received 3 intramuscular injections at days 0, 28, and 56. In the phase 2 trial, 224 adults were randomized to 5 μg/dose in 2 schedule groups (injections on days 0 and 14 [n = 84] vs alum only [n = 28], and days 0 and 21 [n = 84] vs alum only [n = 28]).
Design, Setting, and Participants


Interim analysis of ongoing randomized, double-blind, placebo-controlled, phase 1 and 2 clinical trials to assess an inactivated COVID-19 vaccine. The trials were conducted in Henan Province, China, among 96 (phase 1) and 224 (phase 2) healthy adults aged between 18 and 59 years. Study enrollment began on April 12, 2020. The interim analysis was conducted on June 16, 2020, and updated on July 27, 2020.
Main Outcomes and Measures


The primary safety outcome was the combined adverse reactions 7 days after each injection, and the primary immunogenicity outcome was neutralizing antibody response 14 days after the whole-course vaccination, which was measured by a 50% plaque reduction neutralization test against live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Results


Among 320 patients who were randomized (mean age, 42.8 years; 200 women [62.5%]), all completed the trial up to 28 days after the whole-course vaccination. The 7-day adverse reactions occurred in 3 (12.5%), 5 (20.8%), 4 (16.7%), and 6 (25.0%) patients in the alum only, low-dose, medium-dose, and high-dose groups, respectively, in the phase 1 trial; and in 5 (6.0%) and 4 (14.3%) patients who received injections on days 0 and 14 for vaccine and alum only, and 16 (19.0%) and 5 (17.9%) patients who received injections on days 0 and 21 for vaccine and alum only, respectively, in the phase 2 trial. The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted. The geometric mean titers of neutralizing antibodies in the low-, medium-, and high-dose groups at day 14 after 3 injections were 316 (95% CI, 218-457), 206 (95% CI, 123-343), and 297 (95% CI, 208-424), respectively, in the phase 1 trial, and were 121 (95% CI, 95-154) and 247 (95% CI, 176-345) at day 14 after 2 injections in participants receiving vaccine on days 0 and 14 and on days 0 and 21, respectively, in the phase 2 trial. There were no detectable antibody responses in all alum-only groups.
Conclusions and Relevance


In this interim report of the phase 1 and phase 2 trials of an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity; the study is ongoing. Efficacy and longer-term adverse event assessment will require phase 3 trials.
Trial Registration


Chinese Clinical Trial Registry Identifier: ChiCTR2000031809.",2020,"The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted.","['China', '96 participants', '224 adults', 'Henan Province, China, among 96 (phase 1) and 224 (phase 2) healthy adults aged between 18 and 59 years', '320 patients who were randomized (mean age, 42.8 years; 200 women [62.5']","['aluminum hydroxide (alum) adjuvant-only group', 'investigational inactivated whole-virus COVID-19 vaccine', 'Inactivated Vaccine Against SARS-CoV-2', 'placebo']","['serious adverse reactions', 'antibody responses', 'geometric mean titers of neutralizing antibodies', 'Safety and Immunogenicity Outcomes', 'safety and immunogenicity', 'plaque reduction neutralization test against live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', '7-day adverse reactions', 'neutralizing antibody response']","[{'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517836', 'cui_str': '62.5'}]","[{'cui': 'C0002371', 'cui_str': 'Aluminum Hydroxide'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0027944', 'cui_str': 'Neutralization Tests'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",224.0,0.329137,"The most common adverse reaction was injection site pain, followed by fever, which were mild and self-limiting; no serious adverse reactions were noted.","[{'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Xia', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Duan', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Yuntao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Dongyang', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Huajun', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xinguo', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Peng', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Yanbo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Ministry of Education Key Laboratory of Environment and Health and State Key Laboratory of Environmental Health (Incubation), School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Yunkai', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Xiaoxiao', 'Initials': 'X', 'LastName': 'Gao', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Wangyang', 'Initials': 'W', 'LastName': 'You', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xuewei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Zejun', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Zhengli', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xuqin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Lianghao', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'China National Biotec Group Company Limited, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Public Health, Zhengzhou University, Zhengzhou, Henan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhou', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Shihe', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Jianhui', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Ziyan', 'Initials': 'Z', 'LastName': 'Meng', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Pan', 'Affiliation': 'Department of Epidemiology and Biostatistics, Ministry of Education Key Laboratory of Environment and Health and State Key Laboratory of Environmental Health (Incubation), School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': 'Chinese Academy of Sciences Key Laboratory of Special Pathogens, Wuhan Institute of Virology, Center for Biosafety Mega-Science, Chinese Academy of Sciences, Wuhan, Hubei, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Shen', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}, {'ForeName': 'Wanshen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': 'Henan Center for Disease Control and Prevention, Zhengzhou, Henan, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'National Engineering Technology Research Center for Combined Vaccines, Wuhan Institute of Biological Products Co Ltd, Wuhan, Hubei, China.'}]",JAMA,['10.1001/jama.2020.15543']
1981,32791681,"Effect of ""Tonifying Kidney and Invigorating Brain"" acupuncture in children with spastic cerebral palsy analyzed by multi-modality MRI combined with dynamic electroencephalogram.","INTRODUCTION


Cerebral palsy is the most common motor disability of childhood. Spastic cerebral palsy accounts for 60% to 70% of cases. Research has shown that acupuncture can improve the quality of life of children with cerebral palsy, but the mechanism of action remains unclear. This study aims to determine the effectiveness of acupuncture for treatment of children with spastic cerebral palsy and to assess the value of multimodal magnetic resonance imaging (MRI) and ambulatory electroencephalogram (EEG) for evaluation of treatment effect.
METHODS AND ANALYSIS


This randomized controlled trial will enroll a total of 72 children with CP from 2 hospitals-Jiangsu Province Hospital of Chinese Medicine and Nanjing State Hospital of Pediatric-with 36 participants from each hospital. Patients will be randomly assigned (1:1 ratio) to receive ""Tonifying Kidney and Invigorating Brain"" acupuncture treatment plus standardized physical rehabilitation treatment (treatment group) or only standardized physical rehabilitation (control group). All participants will receive 3 treatment sessions per week for 3 consecutive months; they will then be followed up for another 3 months. The primary outcome measures will include multimodal magnetic resonance imaging (MRI), ambulatory electroencephalogram (EEG), and Gesell Developmental Diagnostic Schedules. The secondary outcome measures will include Gross Motor Function Classification System (GMFCS), Gross Motor Function Measure (GMFM), Functional Independence Measure (WeeFIM), and Modified Ashworth Scale score. Outcome measures (including primary and secondary outcome measures) were collected at the baseline, 3 months and 6 months prior to the intervention.Ethics and dissemination PATIENTS CONSENT:: Obtained.
ETHICS APPROVAL


The central independent ethics committee of Jiangsu Province Hospital of Traditional Chinese Medicine approved the protocol (2017NL-115-02).
SAFETY CONSIDERATIONS


Routine blood tests and liver and kidney function tests will be conducted to exclude patients with severe heart, liver, or kidney diseases. The same examinations will be performed again at the end of the study to detect any possible side effects. Possible acupuncture-related adverse events (e.g., fainting, needle stick injury, local infection, subcutaneous hematoma, and low-grade fever) will be documented. Serious adverse events will be reported to the principal investigator immediately. All unexpected and unintended responses, even those not necessarily related to the acupuncture intervention, will be documented as adverse events.
CASE DROPOUT MANAGEMENT


Participants have a right to withdraw from the study at any time if they feel uncomfortable upon receiving the treatments or being diagnosed with serious complications or diseases. They will then be referred to the preferred department for further treatment and management. If cases of dropout, the researcher need to contact the participant to reason the problem out, collect and record all the necessary assessments on the last visit as well as the date of last visit. All data available until the date of withdrawal will be stored for further statistical analysis.
DISCUSSION


This research is being conducted to assess the value of acupuncture as an intervention for rehabilitation of children with spastic cerebral palsy and also to evaluate the usefulness of multimodal MRI and ambulatory EEG for identifying changes in brain function.
TRIAL REGISTRATION


This trial is registered with Chinese Clinical Trials Register, ChiCTR 1900024546 (registered 15 July 2019; retrospective registration, http://www.chictr.org.cn/showproj.aspx?proj=35763).",2020,"Possible acupuncture-related adverse events (e.g., fainting, needle stick injury, local infection, subcutaneous hematoma, and low-grade fever) will be documented.","['children with cerebral palsy', 'patients with severe heart, liver, or kidney diseases', 'children with spastic cerebral palsy analyzed by multi-modality MRI combined with dynamic electroencephalogram', '72 children with CP from 2 hospitals-Jiangsu Province Hospital of Chinese Medicine and Nanjing State Hospital of Pediatric-with 36 participants from each hospital', 'children with spastic cerebral palsy']","['Tonifying Kidney and Invigorating Brain"" acupuncture treatment plus standardized physical rehabilitation treatment (treatment group) or only standardized physical rehabilitation (control group', 'acupuncture', 'multimodal magnetic resonance imaging (MRI) and ambulatory electroencephalogram (EEG', 'Tonifying Kidney and Invigorating Brain"" acupuncture']","['quality of life', 'Spastic cerebral palsy', 'Gross Motor Function Classification System (GMFCS), Gross Motor Function Measure (GMFM), Functional Independence Measure (WeeFIM), and Modified Ashworth Scale score', 'multimodal magnetic resonance imaging (MRI), ambulatory electroencephalogram (EEG), and Gesell Developmental Diagnostic Schedules', 'adverse events (e.g., fainting, needle stick injury, local infection, subcutaneous hematoma, and low-grade fever']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0020026', 'cui_str': 'State Hospitals'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0394664', 'cui_str': 'Acupuncture'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0430799', 'cui_str': 'Ambulatory EEG'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0430799', 'cui_str': 'Ambulatory EEG'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085178', 'cui_str': 'Injuries, Needlestick'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0520532', 'cui_str': 'Subcutaneous hematoma'}, {'cui': 'C0239574', 'cui_str': 'Low grade pyrexia'}]",72.0,0.0858516,"Possible acupuncture-related adverse events (e.g., fainting, needle stick injury, local infection, subcutaneous hematoma, and low-grade fever) will be documented.","[{'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""aDepartment of Acupuncture, Jiangsu Province Hospital of Traditional Chinese Medicine, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine bNanjing University of Traditional Chinese Medicine cChildren's Hospital of Nanjing Medical University, Nanjing, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Bao', 'Affiliation': ''}, {'ForeName': 'Yan-Xia', 'Initials': 'YX', 'LastName': 'Geng', 'Affiliation': ''}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Elsie Sin May', 'Initials': 'ESM', 'LastName': 'Teo', 'Affiliation': ''}, {'ForeName': 'Jan-Bing', 'Initials': 'JB', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Yan-Cai', 'Initials': 'YC', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Meng-Qian', 'Initials': 'MQ', 'LastName': 'Yuan', 'Affiliation': ''}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zou', 'Affiliation': ''}, {'ForeName': 'Ping-Ping', 'Initials': 'PP', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Zhu', 'Affiliation': ''}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021082']
1982,32791690,Effect of digital storytelling intervention on burnout thoughts of adolescent: Athletes with disabilities.,"BACKGROUND/OBJECTIVE


Both athletes with and without disabilities can develop burnout symptoms. However, athletes with disabilities may face different or more challenges compared to their counterparts without disabilities. The present study aimed at ascertaining the effect of digital storytelling intervention on burnout thoughts of adolescent-athletes with disabilities.
METHOD


This study is a randomized controlled trial involving a total of 171 adolescent-athletes with disabilities who showed a high degree of burnout symptoms. These adolescent-athletes were randomly assigned to either an intervention group (n = 85) or a waitlisted control group (n = 86). The treatment intervention for the adolescent-athletes was digital stories which were created based on the framework of rational emotive behaviour therapy (REBT). The Athlete Burnout Questionnaire was used for gathering of data at three different times (baseline, post-test and follow up). Data were analyzed using repeated measure analysis of variance at a significant level of 0.05.
RESULTS


Results showed that the digital storytelling intervention based on REBT significantly reduced burnout thoughts among disabled adolescent-athletes in the intervention group compared to athletes in the waitlisted control group as measured by the Athlete Burnout Questionnaire. Additionally, at follow-up evaluation, it was observed that the decrease in burnout scores was maintained by those athletes in the digital storytelling intervention.
CONCLUSION


Digital storytelling intervention based on rational emotive behaviour therapy shows great potentials in addressing burnout among adolescent-athletes with disabilities.",2020,"RESULTS


Results showed that the digital storytelling intervention based on REBT significantly reduced burnout thoughts among disabled adolescent-athletes in the intervention group compared to athletes in the waitlisted control group as measured by the Athlete Burnout Questionnaire.","['adolescent: Athletes with disabilities', 'adolescent-athletes with disabilities', '171 adolescent-athletes with disabilities who showed a high degree of burnout symptoms', 'adolescent-athletes']","['Digital storytelling intervention', 'intervention group (n\u200a=\u200a85) or a waitlisted control group', 'digital storytelling intervention', 'REBT']",['burnout scores'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",171.0,0.0186893,"RESULTS


Results showed that the digital storytelling intervention based on REBT significantly reduced burnout thoughts among disabled adolescent-athletes in the intervention group compared to athletes in the waitlisted control group as measured by the Athlete Burnout Questionnaire.","[{'ForeName': 'Theresa Onyema', 'Initials': 'TO', 'LastName': 'Ofoegbu', 'Affiliation': 'aDepartment of Arts Education, University of Nigeria, Nsukka, P.M.B. 410001, Enugu State, Nigeria bHealth Economics, Management and Policy Research Unit, Department of Health Sciences, Alex-Ekwueme Federal University Ndufu-Alike Ikwo, Ebonyi State, Nigeria cDepartment of Educational Foundations, University of Nigeria, Nsukka, P.M.B. 410001, Enugu State, Nigeria dDepartment Human Kinetics and Health Education, University of Nigeria, Nsukka, P.M.B. 410001, Enugu State, Nigeria eDepartment of Sociology/Criminology & Security Studies, Alex-Ekwueme Federal University Ndufu Alike Ikwo, Ebonyi State, Nigeria fDepartment of Accountancy/Business Administration/Banking and Finance, Alex-Ekwueme Federal University Ndufu-Alike Ikwo, Ebonyi State, Nigeria gDepartment of Haematology and Blood Transfusion, Alex-Ekwueme Federal University Teaching Hospital Abakaliki, Ebonyi State, Nigeria.'}, {'ForeName': 'Uche D', 'Initials': 'UD', 'LastName': 'Asogwa', 'Affiliation': ''}, {'ForeName': 'Chimaobi Samuel', 'Initials': 'CS', 'LastName': 'Ogbonna', 'Affiliation': ''}, {'ForeName': 'Henry E', 'Initials': 'HE', 'LastName': 'Aloh', 'Affiliation': ''}, {'ForeName': 'Chiedu', 'Initials': 'C', 'LastName': 'Eseadi', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eskay', 'Affiliation': ''}, {'ForeName': 'Godfrey C', 'Initials': 'GC', 'LastName': 'Nji', 'Affiliation': ''}, {'ForeName': 'Oliver Rotachukwu', 'Initials': 'OR', 'LastName': 'Ngwoke', 'Affiliation': ''}, {'ForeName': 'Christian Iheanacho', 'Initials': 'CI', 'LastName': 'Agboti', 'Affiliation': ''}, {'ForeName': 'Robert Azu', 'Initials': 'RA', 'LastName': 'Nnachi', 'Affiliation': ''}, {'ForeName': 'Oluomachi Charity', 'Initials': 'OC', 'LastName': 'Nnachi', 'Affiliation': ''}, {'ForeName': 'Mkpoikanke S', 'Initials': 'MS', 'LastName': 'Otu', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021164']
1983,32791692,"Effects and safety of intranasal phototherapy for allergic rhinitis: Study protocol for a single-center, randomized, parallel (acupuncture-controlled), open-label, investigator-initiated, pilot study.","INTRODUCTION


Allergic rhinitis (AR) is an immunoglobulin E (Ig E)-mediated inflammatory disease. Intranasal phototherapy is a promising treatment modality because it has a profound immunosuppressive effect, but the evidence of its use for AR is insufficient. Therefore, rigorously designed randomized controlled trials (RCTs) are needed. Our objective is to describe the protocol for an RCT to assess the effects and safety of intranasal phototherapy for the treatment of AR.
METHODS AND ANALYSIS


This is a study protocol for a single-center, randomized, parallel (acupuncture-controlled), open-label, investigator-initiated, pilot study. A total of 80 patients with AR will be randomly assigned to the intranasal phototherapy or acupuncture group at a 1:1 ratio. The participants will receive intranasal phototherapy with medical or acupuncture treatment for 20 minutes, 3 times a week for 4 weeks. The primary outcome will be the mean change in the total nasal symptom score (TNSS) from baseline to 4 weeks. The secondary outcomes will include the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, Nasal Endoscopy Index, total serum immunoglobulin E (Ig E) level and eosinophil count.
DISCUSSION


The findings of this study will provide the basis for the design and implementation of RCTs investigating the effects and safety of intranasal phototherapy for AR. Additionally, it will provide preliminary evidence of intranasal phototherapy for use in AR.
TRIAL REGISTRATION


This study was registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0004079).",2020,The primary outcome will be the mean change in the total nasal symptom score (TNSS) from baseline to 4 weeks.,"['allergic rhinitis', '80 patients with AR']","['intranasal phototherapy', 'Intranasal phototherapy', 'intranasal phototherapy with medical or acupuncture', 'intranasal phototherapy or acupuncture']","['Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, Nasal Endoscopy Index, total serum immunoglobulin E (Ig E) level and eosinophil count', 'mean change in the total nasal symptom score (TNSS']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C5190490', 'cui_str': 'Intranasal phototherapy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0856520', 'cui_str': 'Serum immunoglobulin E'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}]",80.0,0.125628,The primary outcome will be the mean change in the total nasal symptom score (TNSS) from baseline to 4 weeks.,"[{'ForeName': 'Jeongin', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'aDepartment of Ophthalmology, Otolaryngology, and Dermatology, College of Korean Medicine, Woo-Suk University, Jeonju bDepartment of Oriental Rehabilitation, National Rehabilitation Center, Seoul cClinical Medicine Division, Korea Institute of Oriental Medicine dFuture Medicine Division, Korea Institute of Oriental Medicine, Daejeon eClinical Trial Center, Soonchunhyang University Hospital, Cheonan, Korea.'}, {'ForeName': 'Goeun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Miju', 'Initials': 'M', 'LastName': 'Son', 'Affiliation': ''}, {'ForeName': 'Youngeun', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Namhun', 'Initials': 'N', 'LastName': 'Heo', 'Affiliation': ''}, {'ForeName': 'Donghyo', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021183']
1984,32791693,"Effectiveness and safety of polydioxanone thread-embedding acupuncture (TEA) and electroacupuncture (EA) treatment for knee osteoarthritis (KOA) patients with postoperative pain: An assessor-blinded, randomized, controlled pilot trial.","BACKGROUND


Degenerative knee osteoarthritis (KOA) shows an increase in morbidity with improvement in the living conditions and extended lifespans. Treatment for degenerative KOA has been gaining attention since it significantly affects the life of the elderly population and is also associated with increased expenses for medical services and high socioeconomic costs. Treatments for degenerative KOA include nondrug therapy, drug therapy, and surgical treatment. For cases that show little response to conservative treatment but have not involved severe deformation of the knee, procedures such as arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation can be performed. However, effective treatment is required for patients experiencing sustained knee pain after surgery. Although studies confirming the therapeutic effects of acupuncture or thread-embedding acupuncture (TEA) treatment for degenerative KOA have been reported, clinical studies on a combination of TEA and electroacupuncture (EA) in patients complaining of knee pain after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation have not yet been reported. Therefore, this study aimed to evaluate the effectiveness and safety of this combination treatment in patients with persistent knee pain after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation.
METHODS/DESIGN


This study has been designed as a 2-group, parallel, single-center, randomized, controlled, assessor-blinded trial. Thirty-six patients with degenerative KOA who complained of pain even after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation will be randomized to either the (TEA + EA + Usual care) group or the (Usual care only) group in a 1:1 ratio. The patients in the (TEA + EA + Usual care) group will receive TEA treatment once a week for 4 weeks for a total of 4 sessions and EA twice a week for a total of 8 sessions while continuing usual care. The (Usual care only) group will only receive usual care for 4 weeks. To assess the efficacy of the TEA and EA combination treatment, the visual analogue scale, the Korean version of the Western Ontario and McMaster Universities Osteoarthritis Index, the EuroQol 5-Dimension 5-Level, and the doses of the rescue drug taken will be evaluated at baseline (1W) and weeks 2 (2W), 4 (4W), 6 (6W), and 8 (8W). The primary efficacy endpoint is the mean change in visual analogue scale at week 4 (4W) compared to baseline. Adverse events will be assessed at every visit.
DISCUSSION


This study will provide useful data for evaluating the clinical efficacy and safety of TEA and electroacupuncture combination treatment for improving pain and quality of life after surgery for degenerative KOA.
TRIAL REGISTRATION


Clinical Research Information Service of Republic of Korea (CRIS- KCT0004804), March 6, 2020.",2020,"To assess the efficacy of the TEA and EA combination treatment, the visual analogue scale, the Korean version of the Western Ontario and McMaster Universities Osteoarthritis Index, the EuroQol 5-Dimension 5-Level, and the doses of the rescue drug taken will be evaluated at baseline (1W) and weeks 2 (2W), 4 (4W), 6 (6W), and 8 (8W).","['Degenerative knee osteoarthritis (KOA', 'knee osteoarthritis (KOA) patients with postoperative pain', 'patients complaining of knee pain after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation', 'patients with persistent knee pain after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation', 'Thirty-six patients with degenerative KOA who complained of pain even after arthroscopic surgery, autologous chondrocyte implantation, or autologous osteochondral transplantation']","['polydioxanone thread-embedding acupuncture (TEA) and electroacupuncture (EA', 'TEA', 'TEA and electroacupuncture (EA', 'acupuncture or thread-embedding acupuncture (TEA', 'TEA and electroacupuncture combination treatment', 'TEA\u200a+\u200aEA\u200a+\u200aUsual care']","['Adverse events', 'pain and quality of life', 'mean change in visual analogue scale', 'Effectiveness and safety', 'effectiveness and safety', 'visual analogue scale, the Korean version of the Western Ontario and McMaster Universities Osteoarthritis Index']","[{'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0750934', 'cui_str': 'Arthroscopy with surgical procedure'}, {'cui': 'C1446230', 'cui_str': 'Autologous chondrocyte implantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0476169', 'cui_str': 'Osteochondral fracture'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0085242', 'cui_str': 'Polydioxanone'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}]",36.0,0.0890456,"To assess the efficacy of the TEA and EA combination treatment, the visual analogue scale, the Korean version of the Western Ontario and McMaster Universities Osteoarthritis Index, the EuroQol 5-Dimension 5-Level, and the doses of the rescue drug taken will be evaluated at baseline (1W) and weeks 2 (2W), 4 (4W), 6 (6W), and 8 (8W).","[{'ForeName': 'Ye Ji', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'aDepartment of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Daejeon University bClinical Medicine Division, Korea Institute of Oriental Medicine cKorean Medicine Life Science, University of Science and Technology (UST), Campus of Korea Institute of Oriental Medicine, Daejeon dDepartment of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul eDepartment of Korean Medicine Rehabilitation, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.'}, {'ForeName': 'Chang-Hyun', 'Initials': 'CH', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Ju Hyun', 'Initials': 'JH', 'LastName': 'Jeon', 'Affiliation': ''}, {'ForeName': 'Eunseok', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Jin Youp', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Ki Hyun', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Ae Ran', 'Initials': 'AR', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Young Il', 'Initials': 'YI', 'LastName': 'Kim', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021184']
1985,32791721,Maternal bacteria to correct abnormal gut microbiota in babies born by C-section.,"INTRODUCTION


There is evidence that caesarean section (CS) is associated with increased risk of childhood obesity, asthma, and coeliac disease. The gut microbiota of CS-born babies differs to those born vaginally, possibly due to reduced exposure to maternal vaginal bacteria during birth. Vaginal seeding is a currently unproven practice intended to reduce such differences, so that the gut microbiota of CS-born babies is similar to that of babies born vaginally. Our pilot study, which uses oral administration as a novel form of vaginal seeding, will assess the degree of maternal strain transfer and overall efficacy of the procedure for establishing normal gut microbiota development.
METHODS AND ANALYSIS


Protocol for a single-blinded, randomized, placebo-controlled pilot study of a previously untested method of vaginal seeding (oral administration) in 30 CS-born babies. A sample of maternal vaginal bacteria is obtained prior to CS, and mixed with 5 ml sterile water to obtain a supernatant. Healthy babies are randomized at 1:1 to receive active treatment (3 ml supernatant) or placebo (3 ml sterile water). A reference group of 15 non-randomized vaginal-born babies are also being recruited. Babies' stool samples will undergo whole metagenomic shotgun sequencing to identify potential differences in community structure between CS babies receiving active treatment compared to those receiving placebo at age 1 month (primary outcome). Secondary outcomes include differences in overall gut community between CS groups (24 hours, 3 months); similarity of CS-seeded and placebo gut profiles to vaginally-born babies (24 hours, 1 and 3 months); degree of maternal vaginal strain transfer in CS-born babies (24 hours, 1 and 3 months); anthropometry (1 and 3 months) and body composition (3 months).
ETHICS AND DISSEMINATION


Ethics approval by the Northern A Health and Disability Ethics Committee (18/NTA/49). Results will be published in peer-reviewed journals and presented at international conferences.
REGISTRATION


Australian New Zealand Clinical Trials Registry (ACTRN12618000339257).",2020,"The gut microbiota of CS-born babies differs to those born vaginally, possibly due to reduced exposure to maternal vaginal bacteria during birth.","['15 non-randomized vaginal-born babies', '30 CS-born babies', 'Healthy babies', 'babies born by C-section']","['vaginal seeding (oral administration', 'placebo']","['overall gut community between CS groups (24\u200ahours, 3 months); similarity of CS-seeded and placebo gut profiles to vaginally-born babies (24\u200ahours, 1 and 3 months); degree of maternal vaginal strain transfer']","[{'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]",,0.193941,"The gut microbiota of CS-born babies differs to those born vaginally, possibly due to reduced exposure to maternal vaginal bacteria during birth.","[{'ForeName': 'Éadaoin M', 'Initials': 'ÉM', 'LastName': 'Butler', 'Affiliation': ""aA Better Start - National Science Challenge bLiggins Institute, University of Auckland, Auckland, New Zealand cNeonatal Intensive Care Unit, Pescara Public Hospital, Pescara, Italy dDepartment of Women's and Children's Health, Uppsala University, Uppsala, Sweden eEndocrinology Department, Children's Hospital of Zhejiang University School of Medicine, Hangzhou, China fDepartment of Obstetrics and Gynaecology, Auckland City Hospital, Auckland District Health Board, New Zealand.""}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Chiavaroli', 'Affiliation': ''}, {'ForeName': 'José G B', 'Initials': 'JGB', 'LastName': 'Derraik', 'Affiliation': ''}, {'ForeName': 'Celia P', 'Initials': 'CP', 'LastName': 'Grigg', 'Affiliation': ''}, {'ForeName': 'Brooke C', 'Initials': 'BC', 'LastName': 'Wilson', 'Affiliation': ''}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'OʼSullivan', 'Affiliation': ''}, {'ForeName': 'Wayne S', 'Initials': 'WS', 'LastName': 'Cutfield', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021315']
1986,32792614,Alterations in acid-base balance and high-intensity exercise performance after short-term and long-term exposure to acute normobaric hypoxic conditions.,"This investigation assessed the course of renal compensation of hypoxia-induced respiratory alkalosis by elimination of bicarbonate ions and impairments in anaerobic exercise after different durations of hypoxic exposure. Study A: 16 participants underwent a resting 12-h exposure to normobaric hypoxia (3,000 m). Blood gas analysis was assessed hourly. While blood pH was significantly increased, PO 2 , PCO 2 , and SaO 2  were decreased within the first hour of hypoxia, and changes remained consistent. A substantial reduction in [HCO 3 - ] levels was observed after 12 h of hypoxic exposure (- 1.35 ± 0.29 mmol/L, p ≤ 0.05). Study B: 24 participants performed in a randomized, cross-over trial portable tethered sprint running (PTSR) tests under normoxia and after either 1 h (n = 12) or 12 h (n = 12) of normobaric hypoxia (3,000 m). No differences occurred for PTSR-related performance parameters, but the reduction in blood lactate levels was greater after 12 h compared with 1 h (- 1.9 ± 2.2 vs 0.0 ± 2.3 mmol/L, p ≤ 0.05). These results indicate uncompensated respiratory alkalosis after 12 h of hypoxia and similar impairment of high-intensity exercise after 1 and 12 h of hypoxic exposure, despite a greater reduction in blood lactate responses after 12 h compared with 1 h of hypoxic exposure.",2020,"No differences occurred for PTSR-related performance parameters, but the reduction in blood lactate levels was greater after 12 h compared with 1 h (- 1.9 ± 2.2 vs 0.0 ± 2.3 mmol/L, p ≤ 0.05).",[' 16 participants underwent a'],"['resting 12-h exposure to normobaric hypoxia', 'portable tethered sprint running (PTSR) tests under normoxia and after either 1\xa0h (n\u2009=\u200912) or 12\xa0h (n\u2009=\u200912) of normobaric hypoxia']","['PTSR-related performance parameters', 'blood pH', 'PO 2 , PCO 2 , and SaO 2', 'blood lactate levels', 'Blood gas analysis', 'blood lactate responses', 'respiratory alkalosis']",[],"[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0577538', 'cui_str': 'Tethered'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0700308', 'cui_str': 'Protium'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0002064', 'cui_str': 'Respiratory alkalosis'}]",,0.0252108,"No differences occurred for PTSR-related performance parameters, but the reduction in blood lactate levels was greater after 12 h compared with 1 h (- 1.9 ± 2.2 vs 0.0 ± 2.3 mmol/L, p ≤ 0.05).","[{'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Limmer', 'Affiliation': 'Institute of Sports Medicine and Sports Nutrition, Ruhr-University Bochum, Bochum, Germany. mirjam.limmer@rub.de.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'de Marées', 'Affiliation': 'Institute of Sports Medicine and Sports Nutrition, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Platen', 'Affiliation': 'Institute of Sports Medicine and Sports Nutrition, Ruhr-University Bochum, Bochum, Germany.'}]",Scientific reports,['10.1038/s41598-020-70762-z']
1987,32792709,Comparative analgesic efficacy of intravenous vs intrathecal dexmedetomidine as an adjuvant to hyperbaric bupivacaine in subarachnoid block for below knee orthopaedic surgery.,"Background and Aim


Intrathecal and intravenous dexmedetomidine has been used as adjuvant in subarachnoid block [SAB]. The aim of this study was to compare the analgesic efficacy of intravenous vs intrathecal dexmedetomidine as adjuvant to intrathecal bupivacaine.
Methods


Ninety patients, aged 20-60 years belonging to American Society of Anaesthesiologists (ASA) physical status I and II, scheduled for below knee orthopaedic surgeries under SAB were enrolled. In group I ( n  = 45) patients received intravenous dexmedetomidine 0.5 μg/kg in 100 mL 0.9% normal saline [NS] intravenous over a period of 15 minutes given 20 minutes before SAB. Subarachnoid block was given with intrathecal (IT) 0.5% bupivacaine (H) 12.5 mg (2.5 mL) with 0.3 mL of NS. Patients in group II ( n  = 45) received 100 mL of 0.9% NS over a period of 15 minutes given 20 minutes before subarachnoid block. SAB was given with intrathecal 0.5% heavy bupivacaine 12.5 mg with 3 μg of dexmedetomidine (0.3 mL). The primary outcome was duration of analgesia and rescue analgesic requirement, whereas secondary outcome included pain scores.
Results


The duration of analgesia was prolonged in group II (median [IQR]: 5 (6-7.5) h than in group I (median[IQR]: 4[2-4.5] h,  P  = 0.000). Median dose of rescue analgesics over period of 24 hours was less in group II as compared to group I (median [IQR]:150 (75-150) mg vs 195 (150-225) mg,  P  = 0.000). VAS score was lower in group II till 12 h in the postoperative period ( P  = 0.00).
Conclusion


Intrathecal dexmedetomidine is more efficacious as compared to intravenous dexmedetomidine, due to favourable outcomes in terms of increased duration of postoperative analgesia and reduced rescue analgesic requirement.",2020,"The duration of analgesia was prolonged in group II (median [IQR]: 5 (6-7.5) h than in group I (median[IQR]: 4[2-4.5] h,  P  = 0.000).","['subarachnoid block for below knee orthopaedic surgery', 'Methods\n\n\nNinety patients, aged 20-60 years belonging to American Society of Anaesthesiologists (ASA', 'physical status I and II, scheduled for below knee orthopaedic surgeries under SAB were enrolled']","['bupivacaine', 'intrathecal (IT) 0.5% bupivacaine', 'SAB', 'hyperbaric bupivacaine', 'intravenous vs intrathecal dexmedetomidine', 'intravenous dexmedetomidine 0.5 μg/kg in 100 mL 0.9% normal saline [NS] intravenous', 'intrathecal 0.5% heavy bupivacaine', 'dexmedetomidine']","['pain scores', 'duration of analgesia', 'VAS score', 'analgesic efficacy', 'duration of analgesia and rescue analgesic requirement']","[{'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4068881', 'cui_str': '0.9'}, {'cui': 'C0439166', 'cui_str': '% normal'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.269584,"The duration of analgesia was prolonged in group II (median [IQR]: 5 (6-7.5) h than in group I (median[IQR]: 4[2-4.5] h,  P  = 0.000).","[{'ForeName': 'Isha', 'Initials': 'I', 'LastName': 'Sharma', 'Affiliation': 'Department of Anesthesia, Dr Rajendra Medical Govt. College Kangra at Tanda, Himachal Pradesh, India.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Rana', 'Affiliation': 'Department of Anesthesia, Dr Rajendra Medical Govt. College Kangra at Tanda, Himachal Pradesh, India.'}, {'ForeName': 'Bharti', 'Initials': 'B', 'LastName': 'Choudhary', 'Affiliation': 'Department of Anesthesia, Dr Rajendra Medical Govt. College Kangra at Tanda, Himachal Pradesh, India.'}, {'ForeName': 'Tanvi', 'Initials': 'T', 'LastName': 'Dhiman', 'Affiliation': 'Department of Anesthesia, Dr Rajendra Medical Govt. College Kangra at Tanda, Himachal Pradesh, India.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Anesthesia, Dr Rajendra Medical Govt. College Kangra at Tanda, Himachal Pradesh, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Kumar', 'Affiliation': 'Department of Anesthesia, Dr Rajendra Medical Govt. College Kangra at Tanda, Himachal Pradesh, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_219_20']
1988,32792467,"Efficacy and Safety of DWJ1252 Compared With Gasmotin in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Doubleblind, Active-controlled Study.","Background/Aims


Prokinetics such as mosapride citrate (Gasmotin) are commonly used in functional dyspepsia (FD). This study aims to evaluate the efficacy and safety of once-a-day DWJ1252, a sustained-release formulation of Gasmotin, compared with Gasmotin 3 times a day, in patients with FD.
Methods


In this multicenter, randomized, double-blind, active-controlled, non-inferiority study, 119 patients with FD (by the Rome III criteria, 60 for DWJ1252 and 59 for Gasmotin) were randomly allocated to DWJ1252 once daily or Gasmotin thrice daily for 4 weeks in 16 medical institutions. Primary end point was the change in gastrointestinal symptom (GIS) score from baseline, assessed by GIS questionnaires on 5-point Likert scale after 4-week treatment. Secondary end points and safety profiles were also analyzed.
Results


The study included 51 and 49 subjects in the test and control groups, respectively. GIS scores at week 4 were significantly reduced in both groups (mean ± SD: -10.04 ± 4.45 and -10.86 ± 5.53 in the test and control groups, respectively;  P  < 0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, -1.17, 2.81;  P  = 0.643). Changes in GIS at weeks 2 and 4 and quality of life at week 4, and the improvement rates of global assessments at weeks 2 and 4, did not differ between the groups. Adverse events were similar in the 2 groups, and there were no serious adverse events.
Conclusion


In patients with FD, DWJ1252 once daily is as effective as Gasmotin thrice daily, with a similar safety profile.",2020,"GIS scores at week 4 were significantly reduced in both groups (-10.04 ± 4.45 and -10.86 ± 5.53 in the test and control groups, respectively; p<0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, -1.17, 2.81; p=0.643).","['51 and 49 subjects in the test and control groups, respectively', '119 patients with FD (by the Rome III criteria, 60 for DWJ1252 and 59 for Gasmotin ® ', 'functional dyspepsia', 'patients with FD']","['Gasmotin®', 'DWJ1252', 'Gasmotin ®', 'DWJ1252 once daily or Gasmotin ®', 'mosapride citrate (Gasmotin ® ']","['GIS scores', 'Adverse events', 'Efficacy and safety', 'GIS changes', 'efficacy and safety', 'Changes in GIS', 'change in gastrointestinal symptom (GIS) score from baseline, assessed by GIS questionnaires on 5-point Likert scale']","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0245956', 'cui_str': 'mosapride citrate'}]","[{'cui': 'C0815319', 'cui_str': 'Geographical Information Systems'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}]",119.0,0.385485,"GIS scores at week 4 were significantly reduced in both groups (-10.04 ± 4.45 and -10.86 ± 5.53 in the test and control groups, respectively; p<0.001), and the GIS changes from baseline did not differ between the 2 groups (difference, 0.82 point; 95% CI, -1.17, 2.81; p=0.643).","[{'ForeName': 'Jin Hwa', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kang Nyeong', 'Initials': 'KN', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Oh Young', 'Initials': 'OY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Myung-Gyu', 'Initials': 'MG', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Catholic University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyunsoo', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Department of Internal Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Suck-Chei', 'Initials': 'SC', 'LastName': 'Choi', 'Affiliation': 'Department of Internal Medicine, Wonkwang University College of Medicine, Iksan, Jeollabuk-do, Korea.'}, {'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea.'}, {'ForeName': 'Hyo Jin', 'Initials': 'HJ', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University Gangnam Hospital, Seoul, Korea.'}, {'ForeName': 'In-Kyung', 'Initials': 'IK', 'LastName': 'Seong', 'Affiliation': 'Department of Internal Medicine, Konkuk University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chong Il', 'Initials': 'CI', 'LastName': 'Sohn', 'Affiliation': 'Department of Internal Medicine, Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Sam Ryong', 'Initials': 'SR', 'LastName': 'Jee', 'Affiliation': 'Department of Internal Medicine, Inje University College of Medicine, Busan, Korea.'}, {'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Kyunghee University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Poong Lyul', 'Initials': 'PL', 'LastName': 'Rhee', 'Affiliation': 'Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Moo In', 'Initials': 'MI', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Kosin University College of Medicine, Busan, Korea.'}, {'ForeName': 'Joong Goo', 'Initials': 'JG', 'LastName': 'Kwon', 'Affiliation': 'Department of Internal Medicine, Catholic University of Daegu, School of Medicine, Daegu, Korea.'}, {'ForeName': 'Kyung Sik', 'Initials': 'KS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Keimyung University College of Medicine, Daegu, Korea.'}, {'ForeName': 'Kwang Jae', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Ajou University College of Medicine, Suwon, Gyeonggi-do, Korea.'}, {'ForeName': 'Joon Seong', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University College of Medicine, Seoul, Korea.'}]",Journal of neurogastroenterology and motility,['10.5056/jnm20061']
1989,32797070,Learning new sport actions: Pilot study to investigate the imitative and the verbal instructive teaching methods in motor education.,"The aim of the project was to investigate the effects of two strategies of teaching new sport actions on performance of eight-year-old children: observational-imitative method (OIM) and descriptive-directive method (DDM). The OIM group was provided with a pre-practice instruction in the form of expert modeling observation by an expert athlete. The DDM group received only verbal explanations of few selected static images. Thirty-six children (18 males and 18 females, mean age = 8,8) participated in the experiment. Subjects were randomly assigned to the OIM or DDM groups. Participants were instructed to perform four sport motor sequences never performed before (shoulder stand, soccer action, vortex howler throw, step action). Actions were videotaped and 2D kinematic analysis performed. A 10-point Likert questionnaire was administered to blind sport experts to assess the correctness and accuracy of each action. Results suggest that the OIM is the most effective instruction method when participants have no experience with the sport action to be performed. On the contrary, if the athlete needs to learn specific aspects of an exercise (such as grasping a tool) the best method is the DDM. In fact, detailed information on how to grab the vortex helped children in throwing it. We also found gender differences which might reflect cultural influences in specific sports (e.g. soccer). Finally, repetition of the exercise also improved the DDM group's performance. This has potential applications in sport teaching, suggesting that in the absence of a model performing the action to be imitated, the DDM can be as effective as the OIM if the observer repeats the sport action many times.",2020,Results suggest that the OIM is the most effective instruction method when participants have no experience with the sport action to be performed.,"['eight-year-old children', 'Thirty-six children (18 males and 18 females, mean age = 8,8) participated in the experiment']","['teaching new sport actions', 'OIM or DDM']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",[],36.0,0.0155288,Results suggest that the OIM is the most effective instruction method when participants have no experience with the sport action to be performed.,"[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'De Stefani', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Rodà', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Elio', 'Initials': 'E', 'LastName': 'Volta', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Pincolini', 'Affiliation': 'Giocampus Steering Committee, Parma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Farnese', 'Affiliation': 'Giocampus Steering Committee, Parma, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Rossetti', 'Affiliation': 'Giocampus Steering Committee, Parma, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Pedretti', 'Affiliation': 'Giocampus Steering Committee, Parma, Italy.'}, {'ForeName': 'Pier Francesco', 'Initials': 'PF', 'LastName': 'Ferrari', 'Affiliation': 'Department of Medicine and Surgery, University of Parma, Parma, Italy.'}]",PloS one,['10.1371/journal.pone.0237697']
1990,32797125,Ubiquinol supplementation modulates energy metabolism and bone turnover during high intensity exercise.,"Bone and energy metabolism are profoundly influenced by exercise. The objective of this study was to determine for the first time whether a short-term supplementation with ubiquinol could have a modulating effect on bone turnover and energy metabolism associated with strenuous exercise. The participants (n = 100 healthy and well-trained firemen) were randomly divided into two groups: ubiquinol group (ubiquinol (200 mg day-1)) and control group (placebo) for two weeks. The protocol consisted of conducting two identical strenuous exercise tests with a rest period between tests of 24 h. Blood samples were collected before supplementation (basal value) (T1), after supplementation (T2), after the first physical exercise test (T3), after 24 h of rest (T4), and after the second physical exercise test (T5). Parathyroid hormone (PTH), osteocalcin (OC), osteoprotegerin (OPG), osteopontin (OPN), sclerotin (SOST), alkaline phosphatase (AP), adrenocorticotropin (ACTH), insulin, leptin, adrenaline, noradrenaline and peroxisome proliferator activated receptor-γ coactivator-1α (PGC-1α) were determined. Our protocol increased ACTH, SOST, PTH and OC levels, while it decreased OPN. This protocol also increased adrenaline, noradrenaline and PCG-1α, and decreased insulin. After ubiquinol supplementation, PTH, OC, OPG, alkaline phosphatase, leptin, insulin, noradrenaline and PGC-1α levels increased in the supplemented group compared to the control group after the exercise protocol. Strenuous exercise has a clear effect on energy metabolism and bone turnover. These effects are modulated by ubiquinol supplementation, which especially increases the biomarkers of bone formation during strenuous exercise. In addition, ubiquinol has a beneficial effect on the mobilization of energy sources, fact that it could represent an ergogenic and physiological advantage for skeletal muscles.",2020,"After ubiquinol supplementation, PTH, OC, OPG, alkaline phosphatase, leptin, insulin, noradrenaline and PGC-1α levels increased in the supplemented group compared to the control group after the exercise protocol.",['participants (n = 100 healthy and well-trained firemen'],"['ubiquinol group (ubiquinol (200 mg day-1)) and control group (placebo', 'Ubiquinol supplementation', 'Strenuous exercise']","['Parathyroid hormone (PTH), osteocalcin (OC), osteoprotegerin (OPG), osteopontin (OPN), sclerotin (SOST), alkaline phosphatase (AP), adrenocorticotropin (ACTH), insulin, leptin, adrenaline, noradrenaline and peroxisome proliferator activated receptor-γ coactivator-1α (PGC-1α', 'Bone and energy metabolism', 'ACTH, SOST, PTH and OC levels', 'PTH, OC, OPG, alkaline phosphatase, leptin, insulin, noradrenaline and PGC-1α levels', 'adrenaline, noradrenaline and PCG-1α, and decreased insulin', 'bone turnover and energy metabolism', 'energy metabolism and bone turnover']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}]","[{'cui': 'C0077656', 'cui_str': 'ubiquinol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0538161', 'cui_str': 'Tumor Necrosis Factor Receptor 11b'}, {'cui': 'C0069676', 'cui_str': 'Osteopontin'}, {'cui': 'C0074186', 'cui_str': 'sclerotin'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0166418', 'cui_str': 'PPAR'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0265301', 'cui_str': 'Sclerosteosis'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030827', 'cui_str': 'Penicillin G'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",100.0,0.0563639,"After ubiquinol supplementation, PTH, OC, OPG, alkaline phosphatase, leptin, insulin, noradrenaline and PGC-1α levels increased in the supplemented group compared to the control group after the exercise protocol.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Diaz-Castro', 'Affiliation': 'Department of Physiology, University of Granada, Granada, 18071, Spain and Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, Granada, 18071, Spain. jjoh@ugr.es.'}, {'ForeName': 'Pablo Javier', 'Initials': 'PJ', 'LastName': 'Mira-Rufino', 'Affiliation': 'Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, Granada, 18071, Spain. jjoh@ugr.es and Human Nutrition Ph.D. Program, University of Granada, Granada, 18071, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moreno-Fernandez', 'Affiliation': 'Department of Physiology, University of Granada, Granada, 18071, Spain and Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, Granada, 18071, Spain. jjoh@ugr.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Chirosa', 'Affiliation': 'Department of Physical Education, University of Granada, Granada, 18071, Spain.'}, {'ForeName': 'Javier Luis', 'Initials': 'JL', 'LastName': 'Chirosa', 'Affiliation': 'Department of Physical Education, University of Granada, Granada, 18071, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Guisado', 'Affiliation': 'Faculty of Health Sciences, University of Granada, Granada, 18071, Spain.'}, {'ForeName': 'Julio J', 'Initials': 'JJ', 'LastName': 'Ochoa', 'Affiliation': 'Department of Physiology, University of Granada, Granada, 18071, Spain and Institute of Nutrition and Food Technology ""José Mataix"", University of Granada, Granada, 18071, Spain. jjoh@ugr.es.'}]",Food & function,['10.1039/d0fo01147a']
1991,32787905,"Chinese herbal medicine combined with entecavir to reduce the off-therapy recurrence risk in HBeAg-positive chronic hepatitis B patients: a multicener, double-blind, randomized controlled trial in China.","BACKGROUND


Nucleos(t)ide analogues (NAs) are the first-line option against chronic hepatitis B (CHB). NAs produce potent suppression of viral replication with a small chance of HBsAg seroclearance and a high risk of virological relapse after discontinuation. The combined therapy of NAs plus traditional Chinese medicine (TCM) is widely accepted and has been recognized as a prospective alternative approach in China. Based on preliminary works, this study was designed to observe the therapeutic effect of TCM plus entecavir (ETV) against HBeAg-positive chronic hepatitis B with respect to reducing the recurrence risk after NA withdrawal.
METHODS/DESIGN


The study is a nationwide, multicenter, double-blind, randomized, placebo-controlled trial with a duration of 120 weeks. A total of 18 hospitals and 490 eligible Chinese HBeAg-positive CHB patients will be enrolled and randomly allocated into the experimental group and control group in a 1:1 ratio. Patients in the experimental group will be prescribed TCM formulae (Tiaogan-BuXu-Jiedu granules) plus ETV 0.5 mg per day for consolidation therapy for 96 weeks. Patients in the control group will be prescribed TCM granule placebo plus ETV 0.5 mg per day for the same course. After consolidation therapy, all patients will discontinue their trial drugs and be closely monitored over the next 24 weeks. Once clinical recurrence (CR) occurs, ETV treatment will be restarted. The primary outcome is the cumulative rate of CR at the end of this trial.
CONCLUSION


This study is the first of its kind to observe therapeutic effects with respect to reducing recurrence after NA withdrawals after unified integrative consolidation therapy in the CHB population.
TRIAL REGISTRATION


Chinese Clinical Trial Registry No. ChiCTR1900021232 . Registered on February 2, 2019.",2020,NAs produce potent suppression of viral replication with a small chance of HBsAg seroclearance and a high risk of virological relapse after discontinuation.,"['HBeAg-positive chronic hepatitis B patients', 'A total of 18 hospitals and 490 eligible Chinese HBeAg-positive CHB patients']","['Chinese herbal medicine combined with entecavir', 'TCM plus entecavir (ETV', 'NAs plus traditional Chinese medicine (TCM', 'TCM granule placebo plus ETV', 'TCM formulae (Tiaogan-BuXu-Jiedu granules) plus ETV 0.5\u2009mg per day for consolidation therapy', 'placebo']","['cumulative rate of CR', 'virological relapse']","[{'cui': 'C0019167', 'cui_str': 'Hepatitis B e antigen'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1579410', 'cui_str': 'Nucleoside analog'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1577184', 'cui_str': 'entecavir 0.5 MG'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.505256,NAs produce potent suppression of viral replication with a small chance of HBsAg seroclearance and a high risk of virological relapse after discontinuation.,"[{'ForeName': 'Xiaoke', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Ludan', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Qiu', 'Affiliation': 'Department of Hepatology, Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, 518033, Guangdong Province, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Hepatology, Chongqing Traditional Chinese Medicine Hospital, Chongqing, 400021, China.'}, {'ForeName': 'Huanming', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Hepatology, Guangdong Hospital of Traditional Chinese Medicine, Guangzhou, 510006, China.'}, {'ForeName': 'Bingjiu', 'Initials': 'B', 'LastName': 'Lu', 'Affiliation': 'Department of Hepatology, Liaoning Hospital of Traditional Chinese Medicine, Shenyang, 110032, China.'}, {'ForeName': 'Yuyong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Hepatology, Beijing Ditan Hospital, Beijing, 100015, China.'}, {'ForeName': 'Fuli', 'Initials': 'F', 'LastName': 'Long', 'Affiliation': 'Department of Hepatology, The First Affiliated Hospital of Guangxi University of Chinese Medicine, Nanning, 530023, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Hepatology, Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, 350025, China.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Department of Hepatology, Shaanxi Hospital of Traditional Chinese Medicine, Xi'an, 710003, China.""}, {'ForeName': 'Qikai', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""Department of Hepatology, The Third People's Hospital of Shenzhen, Shenzhen, 518112, Guangdong Province, China.""}, {'ForeName': 'Mingxiang', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Hepatology, The Sixth People's Hospital of Shenyang, Shenyang, 110006, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatology, Public Health Clinical Center of Chengdu, Chengdu, 610066, China.'}, {'ForeName': 'Xiaoning', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': 'Department of Hepatology, Affiliated traditional Chinese Medicine Hospital of Southwest Medical University, Luzhou, 646699, China.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Gong', 'Affiliation': 'Department of Hepatology, 302 Military Hospital of China, Beijing, 100039, China.'}, {'ForeName': 'Xuehua', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Hepatology, Shanghai Shuguang Hospital, Shanghai, 200021, China.'}, {'ForeName': 'Jianguang', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Hepatology, Shandong Hospital of Traditional Chinese Medicine, Jinan, 250011, China.'}, {'ForeName': 'Fengxia', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Department of Hepatology, Beijing Chinese Medicine Hospital, Beijing, 100010, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ""Department of Hepatology, The Second People's Hospital of Tianjin, Tianjin, 300000, China.""}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterology, The Second Hospital of Shandong University, Jinan, 250100, China.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Danan', 'Initials': 'D', 'LastName': 'Gan', 'Affiliation': 'Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Xianzhao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Du', 'Affiliation': 'Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China. duhongbo@bucm.edu.cn.'}, {'ForeName': ""Yong'an"", 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Institute of Liver Diseases, Beijing University of Chinese Medicine, Dongzhimen Hospital affiliated to Beijing University of Chinese Medicine, Beijing, 100700, China. yeyongan@vip.163.com.'}]",Trials,['10.1186/s13063-020-04417-9']
1992,32787921,A comparison between the effectiveness of a gamified approach with the conventional approach in point-of-care ultrasonographic training.,"BACKGROUND


Although gamification increases user engagement, its effectiveness in point-of-care ultrasonographic training has yet to be fully established. This study was conducted with the primary outcome of evaluating its effectiveness in point-of-care ultrasonographic training as compared to conventional approach.
METHODS


Participants consisting of junior doctors were randomized into either the (1) gamified or the (2) conventional educational approach for ultrasonographic training.
RESULTS


A total of 31 junior doctors participated in this study (16 participants in gamified arm, 15 in the conventional arm after one participant from the conventional arm dropped out due to work commitment). Two-way mixed ANOVA test showed that there was no statistically significant interaction between the types of educational approach and time of testing (pre-test, post-test, 2 months post-training) for both theoretical knowledge score and practical skills score, with F(2, 58) = 39.6, p < 0.001, partial η 2  = 0.4 and F(2, 58) = 3.06, p = 0.06, partial η 2  = 0.095, respectively. For theoretical knowledge score, pairwise comparisons showed that the mean 2 months post-training scores (20.28 +/- 0.70, 95% CI 18.87-21.69) and mean post-test scores (20.27 +/- 0.65, 95% CI 18.94-21.60) were better than the pre-test scores (12.99 +/- 0.50, 95% CI 11.97-14.00) with p-values < 0.001 for both comparisons respectively. Similarly, for practical skill score, pairwise comparisons showed that the mean 2 months post-training scores (20.28 +/- 0.70, 95% CI 18.87-21.69) and mean post-test scores (20.27 +/- 0.65, 95% CI 18.94-21.60) were also better than the pre-test scores (12.99 +/- 0.50, 95% CI 11.97-14.00) with p-values < 0.001 for both comparisons respectively. Participants in the gamification arm generally perceived the various game elements and game mechanics as useful in contributing and motivating them to learn ultrasonography.
CONCLUSIONS


Gamification approach could be an effective alternative to conventional approach in point-of-care ultrasonographic training.",2020,"Participants in the gamification arm generally perceived the various game elements and game mechanics as useful in contributing and motivating them to learn ultrasonography.
","['Participants consisting of junior doctors', '31 junior doctors participated in this study (16 participants in gamified arm, 15 in the conventional arm after one participant from the conventional arm dropped out due to work commitment']","['care ultrasonographic training', 'conventional educational approach for ultrasonographic training']","['mean post-test scores', 'theoretical knowledge score and practical skills score']","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",31.0,0.204273,"Participants in the gamification arm generally perceived the various game elements and game mechanics as useful in contributing and motivating them to learn ultrasonography.
","[{'ForeName': 'Aaron Kuo Huo', 'Initials': 'AKH', 'LastName': 'Lai', 'Affiliation': 'Emergency and Trauma Department, Sarawak General Hospital, 93586, Kuching, Sarawak, Malaysia.'}, {'ForeName': 'Abdul Muhaimin Bin', 'Initials': 'AMB', 'LastName': 'Noor Azhar', 'Affiliation': 'Faculty of Medicine, University of Malaya, Jalan Universiti, Wilayah Persekutuan Kuala Lumpur, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Aidawati Binti', 'Initials': 'AB', 'LastName': 'Bustam', 'Affiliation': 'Faculty of Medicine, University of Malaya, Jalan Universiti, Wilayah Persekutuan Kuala Lumpur, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Xun Ting', 'Initials': 'XT', 'LastName': 'Tiong', 'Affiliation': 'Clinical Research Centre, Sarawak General Hospital, 93586, Kuching, Sarawak, Malaysia.'}, {'ForeName': 'Hiang Chuan', 'Initials': 'HC', 'LastName': 'Chan', 'Affiliation': 'Emergency and Trauma Department, Sarawak General Hospital, 93586, Kuching, Sarawak, Malaysia.'}, {'ForeName': 'Rashidi Bin', 'Initials': 'RB', 'LastName': 'Ahmad', 'Affiliation': 'Faculty of Medicine, University of Malaya, Jalan Universiti, Wilayah Persekutuan Kuala Lumpur, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Keng Sheng', 'Initials': 'KS', 'LastName': 'Chew', 'Affiliation': 'Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Kota Samarahan, 94300, Kuching, Sarawak, Malaysia. kschew@unimas.my.'}]",BMC medical education,['10.1186/s12909-020-02173-7']
1993,32787925,Protocol for the 3HP Options Trial: a hybrid type 3 implementation-effectiveness randomized trial of delivery strategies for short-course tuberculosis preventive therapy among people living with HIV in Uganda.,"BACKGROUND


Recently, a 3-month (12-dose) regimen of weekly isoniazid and rifapentine (3HP) was recommended by the World Health Organization for the prevention of tuberculosis (TB) among people living with HIV (PLHIV) on common antiretroviral therapy regimens. The best approach to delivering 3HP to PLHIV remains uncertain.
METHODS


We developed a three-armed randomized trial assessing optimized strategies for delivering 3HP to PLHIV. The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda. We plan to recruit 1656 PLHIV, randomized 1:1 to each of the three arms (552 per arm). Using a hybrid type 3 effectiveness-implementation design, this pragmatic trial aims to (1) compare the acceptance and completion of 3HP among PLHIV under three delivery strategies: directly observed therapy (DOT), self-administered therapy (SAT), and informed patient choice of either DOT or SAT (with the assistance of a decision aid); (2) to identify processes and contextual factors that influence the acceptance and completion of 3HP under each delivery strategy; and (3) to estimate the costs and compare the cost-effectiveness of three strategies for delivering 3HP. The three delivery strategies were each optimized to address key barriers to 3HP completion using a theory-informed approach. We hypothesize that high levels of treatment acceptance and completion can be achieved among PLHIV in sub-Saharan Africa and that offering PLHIV an informed choice between the optimized DOT and SAT delivery strategies will result in greater acceptance and completion of 3HP. The design and planned evaluation of the delivery strategies were guided by the use of implementation science conceptual frameworks.
DISCUSSION


3HP-one of the most promising interventions for TB prevention-will not be scaled up unless it can be delivered in a patient-centered fashion. We highlight shared decision-making as a key element of our trial design and theorize that offering PLHIV an informed choice between optimized delivery strategies will facilitate the highest levels of treatment acceptance and completion.
TRIAL REGISTRATION


ClinicalTrials.gov: NCT03934931 ; Registered 2 May 2019.",2020,"The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda.","['people living with HIV (PLHIV', 'people living with HIV in Uganda']","['delivery strategies for short-course tuberculosis preventive therapy', 'isoniazid and rifapentine (3HP']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0740413', 'cui_str': 'Tuberculosis prophylaxis'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0073372', 'cui_str': 'rifapentine'}]",[],,0.196427,"The trial will be conducted at the Mulago Immune Suppression Syndrome (i.e., HIV/AIDS) clinic in Kampala, Uganda.","[{'ForeName': 'Jillian L', 'Initials': 'JL', 'LastName': 'Kadota', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Musinguzi', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Nabunje', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Welishe', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Jackie L', 'Initials': 'JL', 'LastName': 'Ssemata', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Opira', 'Initials': 'O', 'LastName': 'Bishop', 'Affiliation': 'Makerere University Joint AIDS Program, Kampala, Uganda.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Berger', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Devika', 'Initials': 'D', 'LastName': 'Patel', 'Affiliation': 'Department of Surgery, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Sammann', 'Affiliation': 'Department of Surgery, Zuckerberg San Francisco General Hospital, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Katahoire', 'Affiliation': 'Child Health and Development Centre, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Payam', 'Initials': 'P', 'LastName': 'Nahid', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Belknap', 'Affiliation': 'Denver Health and Hospital Authority, Denver, CO, USA.'}, {'ForeName': 'Patrick P J', 'Initials': 'PPJ', 'LastName': 'Phillips', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Namusobya', 'Affiliation': 'University Research Company, Center for Human Services, Department of Defense HIV/AIDS Prevention Program (URC-DHAPP), Kampala, Uganda.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Kamya', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Handley', 'Affiliation': 'Center for Vulnerable Populations at Zuckerberg San Francisco General Hospital and Trauma Center, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Kiwanuka', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Achilles', 'Initials': 'A', 'LastName': 'Katamba', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dowdy', 'Affiliation': 'Uganda Tuberculosis Implementation Research Consortium, Kampala, Uganda.'}, {'ForeName': 'Fred C', 'Initials': 'FC', 'LastName': 'Semitala', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda. semitala@gmail.com.'}, {'ForeName': 'Adithya', 'Initials': 'A', 'LastName': 'Cattamanchi', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine and Center for Tuberculosis, University of California San Francisco, San Francisco, CA, USA.'}]",Implementation science : IS,['10.1186/s13012-020-01025-8']
1994,32787932,Culturally and developmentally adapting group interpersonal therapy for adolescents with depression in rural Nepal.,"BACKGROUND


Evidence-based interventions are needed to reduce depression among adolescents in low- and middle-income countries (LMICs). One approach could be cultural adaptation of psychological therapies developed in high-income countries. We aimed to adapt the World Health Organization's Group Interpersonal Therapy (IPT) Manual for adolescents with depression in rural Nepal.
METHODS


We used a participatory, multi-stage adaptation process involving: translation and clinical review of the WHO Manual; desk reviews of adaptations of IPT in LMICs, and literature on child and adolescent mental health interventions and interpersonal problems in Nepal; a qualitative study to understand experiences of adolescent depression and preferences for a community-based psychological intervention including 25 interviews with adolescent boys and girls aged 13-18 with depression, four focus group discussions with adolescents, four with parents/caregivers and two with teachers, six interviews with community health workers and one with a representative from a local non-governmental organisation (total of 126 participants); training of IPT trainers and facilitators and practice IPT groups; and consultation with a youth mental health advisory board. We used the Ecological Validity Framework to guide the adaptation process.
RESULTS


We made adaptations to optimise treatment delivery and emphasise developmental and cultural aspects of depression. Key adaptations were: integrating therapy into secondary schools for delivery by school nurses and lay community members; adding components to promote parental engagement including a pre-group session with the adolescent and parent to mobilise parental support; using locally acceptable terms for mental illness such as udas-chinta (sadness and worry) and man ko samasya (heart-mind problem); framing the intervention as a training programme to de-stigmatise treatment; and including activities to strengthen relationships between group members. We did not adapt the therapeutic goals of IPT and conserved IPT-specific strategies and techniques, making edits only to the way these were described in the Manual.
CONCLUSIONS


Group IPT can be adapted for adolescents in Nepal and delivered through the education system. A randomised controlled trial is needed to assess the impact and costs of the intervention in this setting. Future research in LMICs to adapt IPT for adolescents could use this adapted intervention as a starting point.",2020,"We aimed to adapt the World Health Organization's Group Interpersonal Therapy (IPT) Manual for adolescents with depression in rural Nepal.
","['adolescents in low- and middle-income countries (LMICs', '25 interviews with adolescent boys and girls aged 13-18 with depression, four focus group discussions with adolescents, four with parents/caregivers and two with teachers, six interviews with community health workers and one with a representative from a local non-governmental organisation (total of 126 participants', 'adolescents with depression in rural Nepal']","['training of IPT trainers and facilitators and practice IPT groups; and consultation with a youth mental health advisory board', 'integrating therapy into secondary schools for delivery by school nurses and lay community members; adding components to promote parental engagement including a pre-group session with the adolescent and parent to mobilise parental support; using locally acceptable terms for mental illness such as udas-chinta (sadness and worry) and man ko samasya (heart-mind problem); framing the intervention as a training programme to de-stigmatise treatment', ""World Health Organization's Group Interpersonal Therapy (IPT) Manual"", 'Culturally and developmentally adapting group interpersonal therapy', 'community-based psychological intervention']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0302833', 'cui_str': 'School nurse'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0418946', 'cui_str': 'Parental support'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C3536794', 'cui_str': 'Unhappiness'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",[],126.0,0.0626019,"We aimed to adapt the World Health Organization's Group Interpersonal Therapy (IPT) Manual for adolescents with depression in rural Nepal.
","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Rose-Clarke', 'Affiliation': ""Department of Global Health and Social Medicine, King's College London, London, WC2B 4BG, UK. kelly.rose-clarke@kcl.ac.uk.""}, {'ForeName': 'Indira', 'Initials': 'I', 'LastName': 'Pradhan', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Kathmandu, Nepal.'}, {'ForeName': 'Pragya', 'Initials': 'P', 'LastName': 'Shrestha', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Kathmandu, Nepal.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'B K', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Kathmandu, Nepal.'}, {'ForeName': 'Jananee', 'Initials': 'J', 'LastName': 'Magar', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Kathmandu, Nepal.'}, {'ForeName': 'Nagendra P', 'Initials': 'NP', 'LastName': 'Luitel', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Kathmandu, Nepal.'}, {'ForeName': 'Delan', 'Initials': 'D', 'LastName': 'Devakumar', 'Affiliation': 'Institute for Global Health, University College London, London, UK.'}, {'ForeName': 'Alexandra Klein', 'Initials': 'AK', 'LastName': 'Rafaeli', 'Affiliation': 'Psychological Services, Ruth and Allen Ziegler Student Services Division, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Clougherty', 'Affiliation': 'Global Mental Health Lab, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Kohrt', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, and Department of Global Health, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Mark J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': 'Transcultural Psychosocial Organization Nepal, Kathmandu, Nepal.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Verdeli', 'Affiliation': 'Global Mental Health Lab, Teachers College, Columbia University, New York, NY, USA.'}]",BMC psychology,['10.1186/s40359-020-00452-y']
1995,32787944,Resident-to-resident elder mistreatment (R-REM) intervention for direct care staff in assisted living residences: study protocol for a cluster randomized controlled trial.,"BACKGROUND


Resident-to-resident elder mistreatment (R-REM) is defined as negative and aggressive physical, sexual, or verbal interactions between (long-term care) residents that in a community setting would likely be construed as unwelcome and have high potential to cause physical and/or psychological harm and distress. R-REM has been established as a serious problem that has a negative impact on the safety, physical well-being, and quality-of-life of residents living in nursing homes. Although there are no in-depth studies, there is evidence that it is prevalent in assisted living residences and associated with a variety of person, environmental, and facility characteristics. The authors conducted the first systematic, prospective study of resident-to-resident elder mistreatment in nursing homes and developed an intervention for direct care staff to enhance knowledge of R-REM and increase reporting and resident safety by reducing falls and associated injuries. The study aim was to examine the effects of this intervention in assisted living residences. The primary distal outcome is falls and injuries, and the key process outcomes are staff knowledge and reporting.
METHODS


Twelve larger licensed assisted living residences with special care dementia units in two New York State regions will be enrolled on a rolling basis and randomized to intervention or usual care. Data derived from five sources, (1) resident interviews, (2) staff informants, (3) observational data, (4) chart, and (5) incident/accident report data, will be collected at baseline and 6 and 12 months with respect to 1050 residents (750 ""downstate"" and 300 ""upstate""). The intervention is three training modules delivered on-site after baseline data collection for front line staff on all shifts in facilities randomized to the intervention. Modules relate to recognition, management, and reporting of resident-to-resident elder mistreatment.
DISCUSSION


Given the movement toward alternative congregate living arrangements for older individuals with significant comorbidities, including cognitive impairment; it is critical to enhance resident safety measured by falls, accidents, and injuries and staff knowledge related to recognition, reporting, and treatment of resident-to-resident aggressive and related negative interactions in such settings. This project is important in developing approaches for ameliorating and preventing R-REM in assisted living residences and enhancing resident safety and quality of life.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03383289 . Registered on 26 December 2017.",2020,The intervention is three training modules delivered on-site after baseline data collection for front line staff on all shifts in facilities randomized to the intervention.,"['assisted living residences', 'Twelve larger licensed assisted living residences with special care dementia units in two New York State regions will be enrolled on a rolling basis and randomized to intervention or usual care', 'older individuals with significant comorbidities, including cognitive impairment']",['Resident-to-resident elder mistreatment (R-REM) intervention'],"['falls and injuries, and the key process outcomes are staff knowledge and reporting']","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0623181,The intervention is three training modules delivered on-site after baseline data collection for front line staff on all shifts in facilities randomized to the intervention.,"[{'ForeName': 'Jeanne A', 'Initials': 'JA', 'LastName': 'Teresi', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Silver', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA. sasilver98@aol.com.'}, {'ForeName': 'Mildred', 'Initials': 'M', 'LastName': 'Ramirez', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Eimicke', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA.'}, {'ForeName': 'Gabriel D', 'Initials': 'GD', 'LastName': 'Boratgis', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, NY, USA.'}, {'ForeName': 'Rhoda', 'Initials': 'R', 'LastName': 'Meador', 'Affiliation': 'Bronfenbrenner Center for Translational Research, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Schultz', 'Affiliation': 'College of Human Ecology, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Lachs', 'Affiliation': 'Division of Geriatrics and Palliative Medicine, The Weill Medical College of Cornell University, New York, NY, USA.'}, {'ForeName': 'Karl A', 'Initials': 'KA', 'LastName': 'Pillemer', 'Affiliation': 'Division of Geriatrics and Palliative Medicine, The Weill Medical College of Cornell University, New York, NY, USA.'}]",Trials,['10.1186/s13063-020-04580-z']
1996,32788743,Efficacy and safety of continuous antiviral therapy from preconception to prevent perinatal transmission of hepatitis B virus.,"Few studies were conducted to assess safety and efficacy of continuous antiviral therapy administrated from preconception. In the present study, 136 eligible women with chronic HBV infection were recruited, and assigned to active chronic hepatitis B (CHB) (Group A, B or C) or chronic HBV carrier (Group D). Antiviral therapy was administrated in preconception (Group A), in early (Group B) or late pregnancy (Group C and Group D). Immunoprophylaxis was administrated to all infants. Mothers' HBV status and ALT were assessed at delivery and 7 months postpartum. Offspring's HBV status was examined at 7 months old. Group A women showed low HBV DNA level and normal ALT throughout pregnancy. All women at delivery had an HBV DNA level of less than 10 6  IU/ml, but the proportion of patients with lower HBV DNA level in Group A was higher than any of other three groups (P < 0.05). No differences in obstetrical complications were found among the four groups. None of infants who completed follow-up showed positive HBsAg at age of 7 months. Congenital malformation and infant growth indicators were similar among study cohorts. Continuous antiviral therapy from preconception to entire pregnancy is effective and safe for active CHB mothers and their infants.",2020,Continuous antiviral therapy from preconception to entire pregnancy is effective and safe for active CHB mothers and their infants.,"['136 eligible women with chronic HBV infection were recruited, and assigned to active chronic hepatitis B (CHB', 'active CHB mothers and their infants']","['Antiviral therapy', 'Immunoprophylaxis', 'continuous antiviral therapy']","['low HBV DNA level and normal ALT', 'positive HBsAg', 'Congenital malformation and infant growth indicators', 'HBV DNA level', 'Efficacy and safety', 'obstetrical complications', 'safety and efficacy', ""Mothers' HBV status and ALT""]","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0520463', 'cui_str': 'Chronic active hepatitis'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0178292', 'cui_str': 'Complication of pregnancy, childbirth and/or the puerperium'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",136.0,0.0306027,Continuous antiviral therapy from preconception to entire pregnancy is effective and safe for active CHB mothers and their infants.,"[{'ForeName': 'Xingfei', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jingsi', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Fetal Medicine and Prenatal Diagnosis, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Liyang', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Xueting', 'Initials': 'X', 'LastName': 'Ou', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'He', 'Affiliation': 'The Medical Centre for Critical Pregnant Women in Guangzhou, Guangzhou, China.'}, {'ForeName': 'Yifen', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'The Medical Centre for Critical Pregnant Women in Guangzhou, Guangzhou, China.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Infectious Diseases, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Haibin', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Fujian Provincial Laboratory for Reproductive Health Research, School of Medicine, Xiamen University, Xiamen, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'Fujian Provincial Laboratory for Reproductive Health Research, School of Medicine, Xiamen University, Xiamen, China.'}, {'ForeName': 'Zhijian', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Obstetrics and Gynecology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Huishu', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics and Gynecology, Guangzhou Women and Children's Medical Center, Guangzhou, China.""}, {'ForeName': 'Guocheng', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics and Gynecology, Guangdong Provincial Maternal and Children's Hospital, Guangzhou, China.""}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Obstetrics and Gynecology, Beijing TsingHua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Beijing, China.'}, {'ForeName': 'Guanxin', 'Initials': 'G', 'LastName': 'Shen', 'Affiliation': 'Department of Immunology, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shiliang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada.'}, {'ForeName': 'Dunjin', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory for Major Obstetric Diseases of Guangdong Province, Guangzhou, China. gzdrchen@gzhmu.edu.cn.'}]",Scientific reports,['10.1038/s41598-020-70644-4']
1997,32788855,RANDOMIZED CONTROLLED TRIAL OF LIMITED FASCIOTOMY WITH INJECTION OF ADIPOSE GRAFT FOR DUPUYTREN'S DISEASE.,"Objective


Dupuytren's disease is a genetic disorder related to the proliferation of myofibroblasts. The pluripotent property of stem cells present in adipose tissue inhibits myofibroblast proliferation. Our study sought to evaluate the effect of stem cell-rich fat grafts in patients that underwent limited fasciotomy.
Methods


We studied 45 patients, in a single-blind, prospective, randomized clinical trial. All patients underwent limited fasciotomy. In one group, fat graft was injected.
Results


The total passive extension deficit results did not exhibit a significant difference. Fat group exhibited worse functional score at 6 months and 1 year postoperatively, such as higher complication rates (43%), when compared with control group (8%), and more pain at 6 weeks follow-up.
Conclusion


Fat grafting associated with limited fasciotomy promotes worse functional results compared to conventional limited fasciotomy in the short term. However, long-term results and recurrence rates should be further assessed. Level of Evidence II, Prospective comparative study.",2020,"Fat group exhibited worse functional score at 6 months and 1 year postoperatively, such as higher complication rates (43%), when compared with control group (8%), and more pain at 6 weeks follow-up.
","['45 patients', 'patients that underwent limited fasciotomy']",['stem cell-rich fat grafts'],"['complication rates', 'total passive extension deficit', 'recurrence rates', 'pain', 'functional score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0185188', 'cui_str': 'Division of fascia'}]","[{'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0844767', 'cui_str': 'Grafting of fat'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",45.0,0.0951548,"Fat group exhibited worse functional score at 6 months and 1 year postoperatively, such as higher complication rates (43%), when compared with control group (8%), and more pain at 6 weeks follow-up.
","[{'ForeName': 'Marina Tommasini C', 'Initials': 'MTC', 'LastName': 'Sambuy', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}, {'ForeName': 'Hugo A', 'Initials': 'HA', 'LastName': 'Nakamoto', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Bolliger', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}, {'ForeName': 'Rames', 'Initials': 'R', 'LastName': 'Mattar', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}, {'ForeName': 'Marcelo R', 'Initials': 'MR', 'LastName': 'Rezende', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}, {'ForeName': 'Teng Hsiang', 'Initials': 'TH', 'LastName': 'Wei', 'Affiliation': 'Universidade de São Paulo, Medical School, Hospital das Clínicas, Institute of Orthopedics and Traumatology, São Paulo, SP, Brazil.'}]",Acta ortopedica brasileira,['10.1590/1413-785220202804233522']
1998,32788865,Resveratrol reduces inflammation-related Prostate Fibrosis.,"Inflammation-related prostate fibrosis (PF) is strongly associated with impaired urethral function and lower urinary tract symptoms (LUTS) severity. The aim of this study was to investigate the effects of RSV in patients with small prostate volume and LUTS. Sixty-four patients with PF were randomized either to RSV therapy (group A= 32 patients) or placebo (group B= 32 patients). At baseline (T0) and after 2-months (T2), patients of both groups underwent administration of NIH-Chronic Prostatic Symptom Index (NIH-CPSI) and International Prostate Symptom Score (IPSS) questionnaires for prostatitis and LUTS, respectively, and Expressed Prostatic Secretion (EPS) assays. After two months, only, group A patients treated with RSV showed significant symptomatic improvement of all NIH-CPSI and IPSS subscale scores, as well as a better EPS assay after prostate massage, in terms of high amount of prostatic volume and reduced white blood cells counts. Our data suggested pharmacological advantage after 2-month treatment with RSV in selected patients with PF for the treatment of voiding and storage complaints.",2020,"After two months, only, group A patients treated with RSV showed significant symptomatic improvement of all NIH-CPSI and IPSS subscale scores, as well as a better EPS assay after prostate massage, in terms of high amount of prostatic volume and reduced white blood cells counts.","['Sixty-four patients with PF', 'patients with small prostate volume and LUTS']","['RSV therapy', 'RSV', 'placebo']","['prostatic volume and reduced white blood cells counts', 'symptomatic improvement of all NIH-CPSI and IPSS subscale scores', 'NIH-Chronic Prostatic Symptom Index (NIH-CPSI) and International Prostate Symptom Score (IPSS) questionnaires']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0426733', 'cui_str': 'Small prostate'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}]","[{'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",64.0,0.0317072,"After two months, only, group A patients treated with RSV showed significant symptomatic improvement of all NIH-CPSI and IPSS subscale scores, as well as a better EPS assay after prostate massage, in terms of high amount of prostatic volume and reduced white blood cells counts.","[{'ForeName': 'Enzo', 'Initials': 'E', 'LastName': 'Vicari', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Catania, 95123 Catania, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Arancio', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Catania, 95123 Catania, Italy.'}, {'ForeName': 'Vito Emanuele', 'Initials': 'VE', 'LastName': 'Catania', 'Affiliation': 'Department of Medical, Surgical Sciences and Advanced Technologies ""G.F. Ingrassia"", University of Catania, 95123 Catania, Italy.'}, {'ForeName': 'Beatrice Ornella', 'Initials': 'BO', 'LastName': 'Vicari', 'Affiliation': 'Research Centre ""The Great Senescence"", University of Catania, 95126 Catania, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Sidoti', 'Affiliation': 'UOSD Medicina Interna Ambulatorio Andrologia & Endocrinologia ARNAS-Garibaldi, 95123 Catania, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Castiglione', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Catania, 95123 Catania, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Malaguarnera', 'Affiliation': 'Research Centre ""The Great Senescence"", University of Catania, 95126 Catania, Italy.'}]",International journal of medical sciences,['10.7150/ijms.44443']
1999,32789011,Optimised patient information materials and recruitment to a study of behavioural activation in older adults: an embedded study within a trial.,"Background:  Printed participant information about randomised controlled trials is often long, technical and difficult to navigate. Improving information materials is possible through optimisation and user-testing, and may impact on participant understanding and rates of recruitment.  Methods:  A study within a trial (SWAT) was undertaken within the CASPER trial. Potential CASPER participants were randomised to receive either the standard trial information or revised information that had been optimised through information design and user testing.  Results:  A total of 11,531 patients were randomised in the SWAT. Rates of recruitment to the CASPER trial were 2.0% in the optimised information group and 1.9% in the standard information group (odds ratio 1.027; 95% CI 0.79 to 1.33; p=0.202).  Conclusions:  Participant information that had been optimised through information design and user testing did not result in any change to rate of recruitment to the host trial.  Registration:  ISRCTN ID ISRCTN02202951; registered on 3 June 2009.",2020,Rates of recruitment to the CASPER trial were 2.0% in the optimised information group and 1.9% in the standard information group (odds ratio 1.027; 95% CI 0.79 to 1.33; p=0.202).  ,"['11,531 patients', 'older adults', 'Potential CASPER participants']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],[],11531.0,0.400413,Rates of recruitment to the CASPER trial were 2.0% in the optimised information group and 1.9% in the standard information group (odds ratio 1.027; 95% CI 0.79 to 1.33; p=0.202).  ,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Knapp', 'Affiliation': 'Department of Health Sciences and the Hull York Medical School, University of York,, York, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gilbody', 'Affiliation': 'Department of Health Sciences and the Hull York Medical School, University of York,, York, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Holt', 'Affiliation': 'School of Healthcare, University of Leeds, Leeds, UK.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Keding', 'Affiliation': 'Department of Health Sciences and the Hull York Medical School, University of York,, York, UK.'}, {'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Mitchell', 'Affiliation': 'Department of Health Sciences and the Hull York Medical School, University of York,, York, UK.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Raynor', 'Affiliation': 'School of Healthcare, University of Leeds, Leeds, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Silcock', 'Affiliation': 'School of Pharmacy and Medical Sciences, University of Bradford, Bradford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'Department of Health Sciences and the Hull York Medical School, University of York,, York, UK.'}]",F1000Research,['10.12688/f1000research.24051.1']
2000,32789516,Effect of D-Cycloserine on the Effect of Concentrated Exposure and Response Prevention in Difficult-to-Treat Obsessive-Compulsive Disorder: A Randomized Clinical Trial.,"Importance


Evidence is lacking for viable treatment options for patients with difficult-to-treat obsessive-compulsive disorder (OCD). It has been suggested that D-cycloserine (DCS) could potentiate the effect of exposure and response prevention (ERP) treatment, but the hypothesis has not been tested among patients with difficult-to-treat OCD.
Objective


To evaluate whether DCS potentiates the effect of concentrated ERP among patients with difficult-to-treat OCD.
Design, Setting, and Participants


The study was a randomized placebo-controlled triple-masked study with a 12-month follow-up. Participants were adult outpatients with difficult-to-treat OCD. A total of 220 potential participants were referred, of whom 36 did not meet inclusion criteria and 21 declined to participate. Patients had either relapsed after (n = 100) or not responded to (n = 63) previous ERP treatment. A total of 9 specialized OCD teams within the public health care system in Norway participated, giving national coverage. An expert team of therapists from the coordinating site delivered treatment. Inclusion of patients started in January 2016 and ended in August 2017. Data analysis was conducted February to September 2019.
Interventions


All patients received individual, concentrated ERP treatment delivered during 4 consecutive days in a group setting (the Bergen 4-day treatment format) combined with 100 mg DCS, 250 mg DCS, or placebo.
Main outcomes and Measures


Change in symptoms of OCD and change in diagnostic status. Secondary outcomes measures included self-reported symptoms of OCD, anxiety, depression, and quality of life.
Results


The total sample of 163 patients had a mean (SD) age of 34.5 (10.9) years, and most were women (117 [71.8%]). They had experienced OCD for a mean (SD) of 16.2 (10.2) years. A total of 65 patients (39.9%) were randomized to receive 100 mg DCS, 67 (41.1%) to 250 mg of DCS, and 31 (19.0%) to placebo. Overall, 91 (56.5%) achieved remission at posttreatment, while 70 (47.9%) did so at the 12-month follow-up. There was no significant difference in remission rates among groups. There was a significant reduction in symptoms at 12 months, and within-group effect sizes ranged from 3.01 (95% CI, 2.38-3.63) for the group receiving 250 mg DCS to 3.49 (95% CI, 2.78-4.18) for the group receiving 100 mg DCS (all P < .001). However, there was no significant effect of treatment group compared with placebo in obsessive-compulsive symptoms (250 mg group at posttreatment: d = 0.33; 95% CI, -0.10 to 0.76; 100 mg group at posttreatment: d = 0.36; 95% CI, -0.08 to 0.79), symptoms of depression and anxiety (eg, Patient Health Questionnaire-9 score among 250 mg group at 12-month follow-up: d = 0.30; 95% CI, -0.17 to 0.76; Generalized Anxiety Disorder-7 score among 100 mg group at 12-month follow-up: d = 0.27; 95% CI, -0.19 to 0.73), and well-being (250 mg group: d = 0.10; 95% CI, -0.42 to 0.63; 100 mg group: d = 0.34; 95% CI, -0.19 to 0.86). No serious adverse effects were reported.
Conclusions and Relevance


In this study, DCS did not potentiate ERP treatment effect, but concentrated ERP treatment was associated with improvement.
Trial Registration


ClinicalTrials.gov identifier: NCT02656342.",2020,"There was a significant reduction in symptoms at 12 months, and within-group effect sizes ranged from 3.01 (95% CI, 2.38-3.63) for the group receiving 250 mg DCS to 3.49 (95% CI, 2.78-4.18) for the group receiving 100 mg DCS (all P < .001).","['patients with difficult-to-treat obsessive-compulsive disorder (OCD', 'A total of 9 specialized OCD teams within the public health care system in Norway participated, giving national coverage', '163 patients had a mean (SD) age of 34.5 (10.9) years, and most were women (117 [71.8', 'A total of 65 patients (39.9', 'Patients had either relapsed after (n\u2009=\u2009100) or not responded to (n\u2009=\u200963) previous ERP treatment', 'patients with difficult-to-treat OCD', 'Difficult-to-Treat Obsessive-Compulsive Disorder', 'A total of 220 potential participants were referred, of whom 36 did not meet inclusion criteria and 21 declined to participate', 'Participants were adult outpatients with difficult-to-treat OCD']","['D-cycloserine (DCS', 'D-Cycloserine', 'Concentrated Exposure and Response Prevention', 'DCS', 'DCS, 250 mg DCS, or placebo', 'placebo']","['symptoms of depression and anxiety (eg, Patient Health Questionnaire-9 score', 'self-reported symptoms of OCD, anxiety, depression, and quality of life', 'obsessive-compulsive symptoms', 'remission rates', 'symptoms', 'symptoms of OCD and change in diagnostic status', 'Generalized Anxiety Disorder-7 score', 'remission', 'serious adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}]","[{'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",220.0,0.476199,"There was a significant reduction in symptoms at 12 months, and within-group effect sizes ranged from 3.01 (95% CI, 2.38-3.63) for the group receiving 250 mg DCS to 3.49 (95% CI, 2.78-4.18) for the group receiving 100 mg DCS (all P < .001).","[{'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Kvale', 'Affiliation': 'Bergen Center for Brain Plasticity, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Bjarne', 'Initials': 'B', 'LastName': 'Hansen', 'Affiliation': 'Bergen Center for Brain Plasticity, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Hagen', 'Affiliation': 'Bergen Center for Brain Plasticity, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Abramowitz', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina, Chapel Hill.'}, {'ForeName': 'Tore', 'Initials': 'T', 'LastName': 'Børtveit', 'Affiliation': 'Bergen Center for Brain Plasticity, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Department of Psychology, University of California, Los Angeles.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'Franklin', 'Affiliation': 'Rogers Memorial Hospital, Oconomowoc, Wisconsin.'}, {'ForeName': 'Svein', 'Initials': 'S', 'LastName': 'Haseth', 'Affiliation': 'Nidaros Outpatient Psychiatric Unit, St. Olavs Hospital, Trondheim, Norway.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Himle', 'Affiliation': 'School of Social Work, Department of Psychiatry, University of Michigan, Ann Arbor.'}, {'ForeName': 'Sigurd', 'Initials': 'S', 'LastName': 'Hystad', 'Affiliation': 'Department for Psychosocial Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Unn Beate', 'Initials': 'UB', 'LastName': 'Kristensen', 'Affiliation': 'Gaustad Hospital, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Gunvor', 'Initials': 'G', 'LastName': 'Launes', 'Affiliation': 'Solvang Outpatient Psychiatric Unit, Sørlandet Hospital, Kristiansand, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Lund', 'Affiliation': 'Division of Psychiatry, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Stian', 'Initials': 'S', 'LastName': 'Solem', 'Affiliation': 'Bergen Center for Brain Plasticity, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Lars-Göran', 'Initials': 'LG', 'LastName': 'Öst', 'Affiliation': 'Bergen Center for Brain Plasticity, Haukeland University Hospital, Bergen, Norway.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.13249']
2001,32784252,Factors promoting physical activity in women with fibromyalgia: a qualitative interview study.,"OBJECTIVES


To gain deeper knowledge of factors promoting physical activity in women with fibromyalgia.
DESIGN


A qualitative study based on semistructured in-depth individual interviews. Analysed using qualitative content analysis.
PARTICIPANTS


Fourteen women with fibromyalgia, age 38-65, recruited from a previous randomised controlled trial investigating the effects of person-centred progressive resistance exercise compared with relaxation therapy.
SETTING


Interviews were conducted in a hospital setting.
RESULTS


The analysis resulted in four categories:  a desire to be physically active, finding the proper level and creating proper conditions, managing pain  and  getting it done .
CONCLUSION


This study reveals several factors both personal and environmental, which promote the ability to be physically active when living with pain and other symptoms of fibromyalgia. The participants expressed that, although they had a desire to be physically active, they needed support and guidance from a professional with adequate knowledge to help them find the proper level of exercise. They also expressed a need for the professional to understand their preferences, and to use these preferences as a basis for creating the proper conditions, helping them learn to manage pain and supporting them in getting the exercise done.",2020,"They also expressed a need for the professional to understand their preferences, and to use these preferences as a basis for creating the proper conditions, helping them learn to manage pain and supporting them in getting the exercise done.","['women with fibromyalgia', 'Fourteen women with fibromyalgia, age 38-65', 'Interviews were conducted in a hospital setting']",['person-centred progressive resistance exercise compared with relaxation therapy'],[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282333', 'cui_str': 'Relaxation training therapy'}]",[],14.0,0.135076,"They also expressed a need for the professional to understand their preferences, and to use these preferences as a basis for creating the proper conditions, helping them learn to manage pain and supporting them in getting the exercise done.","[{'ForeName': 'Anette', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden anette.e.larsson@vgregion.se.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Feldthusen', 'Affiliation': 'Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Kaisa', 'Initials': 'K', 'LastName': 'Mannerkorpi', 'Affiliation': 'Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",BMJ open,['10.1136/bmjopen-2019-031693']
2002,32784257,"Study protocol for the use of photobiomodulation with red or infrared LED on waist circumference reduction: a randomised, double-blind clinical trial.","INTRODUCTION


The search for non-invasive procedures to reduce localised adiposity in aesthetics clinics has recently been increasing. In this context, procedures, such as cryolipolysis, ultracavitation, photobiomodulation (PBM) and other techniques have been proposed. Some studies have shown that PBM can be used in body contouring. However, there is no standardisation of the protocol. More than that, as in other techniques for reducing adipose tissue, the availability of triacylglycerol may affect the lipid profile in the blood, bringing consequences to the general health of an individual. This work will aim to compare the light wavelengths when using PBM as a technique for reducing the abdominal waist circumference, while also evaluating the efficacy of the method. Changes in the lipid profile in the blood, with a long-term follow-up, will also be appraised.
METHODS AND ANALYSIS


This will be a controlled, randomised, double-blind, single-centred clinical trial. 174 patients will be recruited at the Nove de Julho University, Brazil, and then divided into three groups: Group A-RED PBM; Group B-INFRARED PBM; Group C-PLACEBO ( Sham ) treatment. The treatments will consist of eight sessions, two times a week, for 4 weeks. At each session, the participants will receive 30 minutes PBM (using a radiant exposure of 127 J/cm 2 ), with an abdominal strap containing 4 LED clusters, with 72 devices each, following the indication of randomisation. All of the groups will receive 30 min of Aussie Current, at 4 kHz, modulated at 10 Hz, 40-60 mA. The main outcome of this study will be waist circumference reduction. The secondary variables will be anthropometric data, lipid profile, liver function and adipose tissue thickness, changes in the local microcirculation, and the quality of life and self-esteem. The analyses will be performed at four stages of the research, D0, end of the eighth session (D30), 15 days after the last session (FU15), 90 days after the last session (FU90) and 180 days after the last session (FU180).
ETHICS AND DISSEMINATION


The Ethics Committee of the Nove de Julho University, Brazil, approved the modified version of this project under No. 3414146 on 26 June 2019. This study is not yet recruiting. The results obtained will be published in a peer-reviewed journal in the related field.
TRIAL REGISTRATION NUMBER


Brazilian Registry of Clinical Trials-ReBec (RBR-9bwxcx).",2020,The search for non-invasive procedures to reduce localised adiposity in aesthetics clinics has recently been increasing.,"['174 patients will be recruited at the Nove de Julho University, Brazil, and then divided into three groups']","['photobiomodulation with red or infrared LED', 'Group A-RED PBM', 'PBM']","['abdominal waist circumference', 'anthropometric data, lipid profile, liver function and adipose tissue thickness, changes in the local microcirculation, and the quality of life and self-esteem', 'waist circumference reduction']","[{'cui': 'C4517604', 'cui_str': '174'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C1532326', 'cui_str': 'Infra-red'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",174.0,0.176906,The search for non-invasive procedures to reduce localised adiposity in aesthetics clinics has recently been increasing.,"[{'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Marreira', 'Affiliation': 'Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Sao Paulo, Brazil.'}, {'ForeName': 'Lidiane', 'Initials': 'L', 'LastName': 'Rocha Mota', 'Affiliation': 'Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Sao Paulo, Brazil.'}, {'ForeName': 'Daniela Fátima Teixeira', 'Initials': 'DFT', 'LastName': 'Silva', 'Affiliation': 'Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Sao Paulo, Brazil.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Pavani', 'Affiliation': 'Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Sao Paulo, Brazil chrispavani@gmail.com.'}]",BMJ open,['10.1136/bmjopen-2019-036684']
2003,32784263,'Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing' (PIVOT with MI) trial: a protocol for a cluster randomised controlled trial of a clinician vaccine communication intervention.,"INTRODUCTION


A key contributor to underimmunisation is parental refusal or delay of vaccines due to vaccine concerns. Many clinicians lack confidence in communicating with vaccine-hesitant parents (VHP) and perceive that their discussions will do little to change parents' minds. Improving clinician communication with VHPs is critical to increasing childhood vaccine uptake.
METHODS AND ANALYSIS


We describe the protocol for a cluster randomised controlled trial to test the impact of a novel, multifaceted clinician vaccine communication strategy on child immunisation status. The trial will be conducted in 24 primary care practices in two US states (Washington and Colorado). The strategy is called Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT with MI), and involves clinicians initiating the vaccine conversation with all parents of young children using the presumptive format, and among those parents who resist vaccines, pivoting to using MI. Our primary outcome is the immunisation status of children of VHPs at 19 months, 0 day of age expressed as the percentage of days underimmunised from birth to 19 months for 22 doses of eight vaccines recommended during this interval. Secondary outcomes include clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy.
ETHICS AND DISSEMINATION


This study is approved by the following institutional review boards: Colorado Multiple Institutional Review Board, Washington State Institutional Review Board and Swedish Health Services Institutional Review Board. Results will be disseminated through peer-reviewed manuscripts and conference presentations.
TRIAL REGISTRATION NUMBER


NCT03885232.",2020,"Secondary outcomes include clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy.
","['24 primary care practices in two US states (Washington and Colorado', 'child immunisation status']","['clinician vaccine communication intervention', 'multifaceted clinician vaccine communication strategy', 'Motivational Interviewing (PIVOT with MI']","['clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy', 'immunisation status of children of VHPs']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0552506', 'cui_str': 'Immunization status'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1274143', 'cui_str': 'Communication interventions'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0552506', 'cui_str': 'Immunization status'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",24.0,0.0932297,"Secondary outcomes include clinician experience communicating with VHPs, parent visit experience and clinician adherence to the PIVOT with MI communication strategy.
","[{'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Opel', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA douglas.opel@seattlechildrens.org.""}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Robinson', 'Affiliation': 'Department of Communication, Portland State University, Portland, Oregon, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Spielvogle', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Spina', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Garrett', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Dempsey', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Cathryn', 'Initials': 'C', 'LastName': 'Perreira', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Dickinson', 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pahud', 'Affiliation': 'Department of Pediatrics, University of Missouri-Kansas City, Kansas City, Missouri, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Department of Pediatrics, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': ""Children's Hospital Colorado, Aurora, Colorado, USA.""}]",BMJ open,['10.1136/bmjopen-2020-039299']
2004,32785245,Impact of an acceptance facilitating intervention on psychotherapists' acceptance of blended therapy.,"Blended therapy is a new approach combining advantages of face-to-face psychotherapy and Internet- and mobile-based interventions. Acceptance is a fundamental precondition for its implementation. The aim of this study was to assess 1) the acceptance of psychotherapists towards blended therapy, 2) the effectiveness of an acceptance facilitating intervention (AFI) on psychotherapists' acceptance towards blended therapy and 3) to identify potential effect moderators. Psychotherapists (N = 284) were randomly assigned to a control (CG) or an intervention group (IG). The IG received a short video showing an example of blended therapy, the CG an attention placebo video. Both groups received a reliable online questionnaire assessing acceptance, effort expectancy, performance expectancy, facilitating conditions, social influence and internet anxiety. Between group differences were examined using t-tests and Mann-Whitney tests. Exploratory analysis was conducted to identify moderators. Psychotherapists in CG showed mixed baseline acceptance towards blended therapy (low = 40%, moderate = 33%, high = 27%). IG showed significantly higher acceptance compared to CG (d = .27, pone-sided = .029; low = 24%, moderate = 47%, high = 30%). Bootstrapped confidence intervals were overlapping. Performance expectancy (d = .35), effort expectancy (d = .44) and facilitating conditions (d = .28) were significantly increased (p < .05). No effects on social influence and internet anxiety were found (p>.05). Exploratory analysis indicated psychodynamic oriented psychotherapists profiting particularly from the AFI. Blended therapy is a promising approach to improve healthcare. Psychotherapists show mixed acceptance, which might be improvable by AFIs, particularly in subpopulations of initially rather skeptical psychotherapists. Forthcoming studies should extend the present study by shifting focus from attitudes to the impact of different forms of AFIs on uptake.",2020,"IG showed significantly higher acceptance compared to CG (d = .27, pone-sided = .029; low = 24%, moderate = 47%, high = 30%).",['Psychotherapists (N = 284'],"['control (CG', 'acceptance facilitating intervention (AFI', 'acceptance facilitating intervention']","['social influence and internet anxiety', 'effort expectancy', 'Performance expectancy', 'reliable online questionnaire assessing acceptance, effort expectancy, performance expectancy, facilitating conditions, social influence and internet anxiety']","[{'cui': 'C0557555', 'cui_str': 'Psychotherapist'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",284.0,0.0280326,"IG showed significantly higher acceptance compared to CG (d = .27, pone-sided = .029; low = 24%, moderate = 47%, high = 30%).","[{'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Baumeister', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Yannik', 'Initials': 'Y', 'LastName': 'Terhorst', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Grässle', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Freudenstein', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Nübling', 'Affiliation': 'Chamber of Psychotherapists Baden-Württemberg, Stuttgart, Germany.'}, {'ForeName': 'David Daniel', 'Initials': 'DD', 'LastName': 'Ebert', 'Affiliation': 'Faculty of Behavioural and Movement Sciences, Clinical, Neuro- & Developmental Psychology, VU Amsterdam, Amsterdam, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0236995']
2005,32785281,The impact of structured sleep schedules prior to an in-laboratory study: Individual differences in sleep and circadian timing.,"INTRODUCTION


Many sleep and circadian studies require participants to adhere to structured sleep-wake schedules designed to stabilize sleep outcomes and circadian phase prior to in-laboratory testing. The effectiveness of this approach has not been rigorously evaluated, however. We therefore investigated the differences between participants' unstructured and structured sleep over a three-week interval.
METHODS


Twenty-three healthy young adults completed three weeks of sleep monitoring, including one week of unstructured sleep and two weeks of structured sleep with consistent bed and wake times. Circadian phase was assessed via salivary dim light melatonin onset (DLMO) during both the unstructured and structured sleep episodes.
RESULTS


Compared to their unstructured sleep schedule, participants' bed- and wake times were significantly earlier in their structured sleep, by 34 ± 44 mins (M ± SD) and 44 ± 41 mins, respectively. During structured sleep, circadian phase was earlier in 65% of participants (40 ± 32 mins) and was later in 35% (41 ± 25 mins) compared to unstructured sleep but did not change at the group level. While structured sleep reduced night-to-night variability in sleep timing and sleep duration, and improved the alignment (phase angle) between sleep onset and circadian phase in the most poorly aligned individuals (DLMO < 1h or > 3h before sleep onset time; 25% of our sample), sleep duration and quality were unchanged.
CONCLUSION


Our results show adherence to a structured sleep schedule results in more regular sleep timing, and improved alignment between sleep and circadian timing for those individuals who previously had poorer alignment. Our findings support the use of structured sleep schedules prior to in-laboratory sleep and circadian studies to stabilize sleep and circadian timing in healthy volunteers.",2020,"During structured sleep, circadian phase was earlier in 65% of participants (40 ± 32 mins) and was later in 35% (41 ± 25 mins) compared to unstructured sleep but did not change at the group level.","['healthy volunteers', 'Twenty-three healthy young adults']",[],['sleep duration and quality'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]",[],"[{'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",23.0,0.0294388,"During structured sleep, circadian phase was earlier in 65% of participants (40 ± 32 mins) and was later in 35% (41 ± 25 mins) compared to unstructured sleep but did not change at the group level.","[{'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'McMahon', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Ftouni', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew J K', 'Initials': 'AJK', 'LastName': 'Phillips', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Beatty', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Lockley', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Shanthakumar M W', 'Initials': 'SMW', 'LastName': 'Rajaratnam', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Maruff', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sean P A', 'Initials': 'SPA', 'LastName': 'Drummond', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Anderson', 'Affiliation': 'School of Psychological Sciences and Turner Institute for Brain and Mental Health, Monash University, Melbourne, Victoria, Australia.'}]",PloS one,['10.1371/journal.pone.0236566']
2006,32797382,Implementation of Universal HIV Testing and Treatment to Reduce HIV Incidence in Botswana: the Ya Tsie Study.,"PURPOSE OF REVIEW


Antiretroviral treatment (ART) can dramatically reduce the risk of HIV transmission, but the feasibility of scaling up HIV testing, linkage and treatment to very high population levels, and its impact on population HIV incidence, were unknown. We review key findings from a community-randomized trial in which we evaluated the impact of ""universal test and treat"" (UTT) on population HIV incidence in Botswana, a resource-constrained country with both high HIV prevalence and high ART coverage before study inception.
RECENT FINDINGS


We conducted a community-randomized trial (the ""Ya Tsie"" trial or Botswana Combination Prevention Project (BCPP)) in 30 villages in Botswana from 2013 to 2018, with the goal of determining whether a combination of prevention interventions-with a focus on universal HIV testing and treatment-would reduce population-level HIV incidence. The intervention included universal HIV testing (home-based and mobile), active linkage to HIV care and treatment with patient tracing for persons not linking, universal ART coverage, rapid ART start (at the first clinic visit), and enhanced male circumcision services. Botswana had very high HIV diagnosis, treatment, and viral suppression levels (approaching the UNAIDS ""90-90-90"" targets) prior to intervention roll-out. By study end, we were able to exceed the overall 95-95-95 coverage target of 86%: an estimated 88% of all persons living with HIV were on ART and had viral suppression in the Ya Tsie intervention arm. In addition, annual HIV incidence was 30% lower in the intervention arm as compared with the control arm over a 29-month follow-up period. With universal HIV testing and relatively simple linkage activities, it was possible to achieve one of the highest reported population levels of HIV diagnosis, linkage to care, and viral suppression globally and to reduce population HIV incidence by about one-third over a short period of time (< 3 years). We were able to significantly increase population viral suppression and to decrease HIV incidence even in a resource-constrained setting with pre-existing very high testing and treatment coverage. Universal community-based HIV testing and tracing of individuals through the HIV care cascade were key intervention components.",2020,We were able to significantly increase population viral suppression and to decrease HIV incidence even in a resource-constrained setting with pre-existing very high testing and treatment coverage.,"['30 villages in Botswana from 2013 to 2018, with the goal of determining whether a combination of prevention interventions-with a focus on universal HIV testing and treatment-would reduce population-level HIV incidence', 'overall 95-95-95 coverage target of 86%: an estimated 88% of all persons living with HIV were on ART and had viral suppression in the Ya Tsie intervention arm', 'population HIV incidence in Botswana, a resource-constrained country with both high HIV prevalence and high ART coverage before study inception']","['Botswana Combination Prevention Project (BCPP', 'universal test and treat"" (UTT', 'universal HIV testing (home-based and mobile), active linkage to HIV care and treatment with patient tracing for persons not linking, universal ART coverage, rapid ART start']","['viral suppression levels', 'annual HIV incidence', 'population viral suppression']","[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006041', 'cui_str': 'Botswana'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442822', 'cui_str': 'Trace'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",,0.0761354,We were able to significantly increase population viral suppression and to decrease HIV incidence even in a resource-constrained setting with pre-existing very high testing and treatment coverage.,"[{'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Lockman', 'Affiliation': ""Brigham and Women's Hospital, PBB-A4, 15 Francis Street, Boston, MA, 02115, USA. slockman@hsph.harvard.edu.""}, {'ForeName': 'Molly Pretorius', 'Initials': 'MP', 'LastName': 'Holme', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Makhema', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Bachanas', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Kathleen E', 'Initials': 'KE', 'LastName': 'Wirth', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Refeletswe', 'Initials': 'R', 'LastName': 'Lebelonyane', 'Affiliation': 'Ministry of Health and Wellness, Gaborone, Botswana.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Essex', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",Current HIV/AIDS reports,['10.1007/s11904-020-00523-0']
2007,32797390,Comparative Efficacy of Doxycycline vs. Azithromycin in Pediatric Scrub Typhus.,,2020,,['Pediatric Scrub Typhus'],['Doxycycline vs. Azithromycin'],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C2946035', 'cui_str': 'Scrubs'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]",[],,0.0236428,,"[{'ForeName': 'Thirunavukkarasu', 'Initials': 'T', 'LastName': 'Arun Babu', 'Affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences (AIIMS), Mangalagiri, Andhra Pradesh, 522 503, India. babuarun@yahoo.com.'}, {'ForeName': 'Dinesh Kumar', 'Initials': 'DK', 'LastName': 'Narayanasamy', 'Affiliation': 'Department of Pediatrics, JIPMER, Karaikal, Pondicherry, India.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Mathiyalagen', 'Affiliation': 'Department of Community Medicine, Indira Gandhi Medical College and Research Institute, Pondicherry, India.'}]",Indian journal of pediatrics,['10.1007/s12098-020-03469-8']
2008,32797473,"The effects of testosterone replacement therapy in men with age-dependent hypogonadism on body composition, and serum levels of leptin, adiponectin and C-reactive protein.","INTRODUCTION


Age-related hypogonadism in men leads to abnormal body composition development and inflammatory cytokines overproduction, thus has atherogenic and potentially cancer promoting effects. Design of the study was to assess the effect of age-dependent testosterone deficiency replacement in men on body composition, serum leptin, adiponectin and C-reactive protein levels.
MATERIAL/METHODS


Men aged 50-65 years (56.0±5.7, average±SD), with total testosterone levels <4 ng/mL and clinical symptoms of hypogonadism were divided into two groups of 20 men and treated with testosterone (200 mg/2 weeks intramuscularly) or placebo during 12 months.
RESULTS


12 months treatment with testosterone led to body mass index (BMI) and fat mass (FM) decrease from 26.6±2.1 to 26.1±1.8 kg/m2, P<0.05, and from 17.0±4.4 to 15.6±4.0 kg, P<0.05, respectively. BMI and FM did not change in placebo receiving subjects. Serum leptin and high-selective C-reactive protein (hsCRP) levels in testosterone group decreased from 6.2±1.4 to 4.0±1.2 μg/L, P< 0.05, and from 1.4±1.2 to 1.0±1.0 mg/L, P< 0.05 after 12 months, respectively. Adiponectin increased from 7.6±2.5μg/mL to 9.4±2.8 μg/mL, P< 0.05 in the same time. In placebo group serum leptin, adiponectin and hsCRP levels did not change significantly.
CONCLUSIONS


Testosterone replacement in men with age-related hypogonadism causes a decrease in body mass index, fat mass, serum leptin and C-reactive protein levels, and increases serum adiponectin levels.",2020,"Serum leptin and high-selective C-reactive protein (hsCRP) levels in testosterone group decreased from 6.2±1.4 to 4.0±1.2 μg/L, P< 0.05, and from 1.4±1.2 to 1.0±1.0 mg/L, P< 0.05 after 12 months, respectively.","['Men aged 50-65 years (56.0±5.7, average±SD), with total testosterone levels <4 ng/mL and clinical symptoms of hypogonadism were divided into two groups of 20 men and treated with', 'men with age-dependent hypogonadism on body composition, and serum levels of leptin, adiponectin and C-reactive protein']","['testosterone', 'testosterone deficiency replacement', 'Testosterone replacement', 'testosterone replacement therapy', 'placebo']","['body composition, serum leptin, adiponectin and C-reactive protein levels', 'body mass index, fat mass, serum leptin and C-reactive protein levels', 'serum leptin, adiponectin and hsCRP levels', 'serum adiponectin levels', 'body mass index (BMI) and fat mass (FM) decrease', 'Adiponectin', 'BMI and FM', 'Serum leptin and high-selective C-reactive protein (hsCRP) levels']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0020619', 'cui_str': 'Hypogonadism'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C1963961', 'cui_str': 'Testosterone deficiency'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C4510497', 'cui_str': 'Testosterone replacement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",,0.0958921,"Serum leptin and high-selective C-reactive protein (hsCRP) levels in testosterone group decreased from 6.2±1.4 to 4.0±1.2 μg/L, P< 0.05, and from 1.4±1.2 to 1.0±1.0 mg/L, P< 0.05 after 12 months, respectively.","[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Dudek', 'Affiliation': ''}, {'ForeName': 'Jarosław', 'Initials': 'J', 'LastName': 'Kozakowski', 'Affiliation': 'jkozakowski@cmkp.edu.pl.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zgliczyński', 'Affiliation': ''}]",Endokrynologia Polska,['10.5603/EP.a2020.0048']
2009,32797480,A Home and School Support Project for Children Excluded from Primary and First Year Secondary School.,"BACKGROUND


In the last 10 years the problem of exclusion has reached a crisis point. Research suggests that exclusion is a complex phenomenon that needs involvement from all the involved services such as Health, Education and Social Services.
METHOD


One hundred and twenty-four pupils, aged 4-12 years who, through school and social exclusion, were at risk of developing more serious mental health difficulties, were randomly allocated to standard care (n = 62) or standard care plus the new intervention (n = 62).
RESULTS


There were no significant differences in the primary outcomes between the two groups at either of the outcome assessments. However, the intervention group with non-compliance cases removed from the analysis did significantly better ( p < . 014, 95%CI -12.8 to -1.4).
CONCLUSIONS


The Home and School Support project managed to reduce the number of excluded days and the appearance of mental health symptoms for pupils who engaged fully with the intervention. The project also highlights the importance of multi-agency involvement at a very early stage.",2004,The Home and School Support project managed to reduce the number of excluded days and the appearance of mental health symptoms for pupils who engaged fully with the intervention.,"['One hundred and twenty-four pupils, aged 4-12\u2003years who, through school and social exclusion, were at risk of developing more serious mental health difficulties', 'pupils who engaged fully with the intervention', 'Children Excluded from Primary and First Year Secondary School']",['standard care (n\u2003=\u200362) or standard care plus the new intervention'],[],"[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0034121', 'cui_str': 'Pupil structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0237827', 'cui_str': 'Social exclusion'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0226731,The Home and School Support project managed to reduce the number of excluded days and the appearance of mental health symptoms for pupils who engaged fully with the intervention.,"[{'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Panayiotopoulos', 'Affiliation': 'The Manchester University, School of Psychiatry, Maths Tower, Oxford Road, Manchester M13 9PL, UK. E-mail: mdpjsmk@fs1.pc.man.ac.uk.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kerfoot', 'Affiliation': 'The Manchester University, School of Psychiatry, Maths Tower, Oxford Road, Manchester M13 9PL, UK. E-mail: mdpjsmk@fs1.pc.man.ac.uk.'}]",Child and adolescent mental health,['10.1111/j.1475-3588.2004.00091.x']
2010,32797502,Multisystemic Treatment of Antisocial Adolescents in Norway: Replication of Clinical Outcomes Outside of the US.,"BACKGROUND


MST is an intensive home- and community-based intervention for youths with serious antisocial behaviour and other serious clinical problems, which has been effective at reducing out-of-home placements and producing favourable long-term clinical outcomes in the US. The aims of the study were to determine the degree to which these outcomes would be replicated in Norway for youths with serious behaviour problems and to conduct a randomised trial of MST by an independent team of investigators.
METHOD


Participants were 100 seriously antisocial youths in Norway who were randomly assigned to Multisystemic Therapy (MST) or usual Child Welfare Services (CS) treatment conditions. Data were gathered from youths, parents, and teachers pre- and post-treatment.
RESULTS


MST was more effective than CS at reducing youth internalising and externalising behaviours and out-of-home placements, as well as increasing youth social competence and family satisfaction with treatment.
DISCUSSION


This is the first study of MST outside of the US and one of the first not conducted by the developers of MST. The findings replicate those obtained by MST's developers and demonstrate the generalisability of short-term MST effects beyond the US.",2004,"MST was more effective than CS at reducing youth internalising and externalising behaviours and out-of-home placements, as well as increasing youth social competence and family satisfaction with treatment.
","['Participants were 100 seriously antisocial youths in Norway who were randomly assigned to', 'youths with serious behaviour problems', 'Antisocial Adolescents in Norway']","['Multisystemic Therapy (MST) or usual Child Welfare Services (CS) treatment conditions', 'MST']",['youth social competence and family satisfaction'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0233523', 'cui_str': 'Antisocial behavior'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C3840203', 'cui_str': 'Multisystemic therapy'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",100.0,0.0255462,"MST was more effective than CS at reducing youth internalising and externalising behaviours and out-of-home placements, as well as increasing youth social competence and family satisfaction with treatment.
","[{'ForeName': 'Terje', 'Initials': 'T', 'LastName': 'Ogden', 'Affiliation': 'The Norwegian Center for Studies on Conduct Problems and Innovative Practice, Oslo, Norway, E-mail: terjeo@psykologi.uio.no.'}, {'ForeName': 'Colleen A', 'Initials': 'CA', 'LastName': 'Halliday-Boykins', 'Affiliation': 'Family Services Research Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, USA, E-mail: hallidca@musc.edu.'}]",Child and adolescent mental health,['10.1111/j.1475-3588.2004.00085.x']
2011,32796401,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Saccharomyces boulardii in Infants and Children With Acute Diarrhea.","AIM


This study was designed to assess the efficacy and safety of Saccharomyces cerevisiae variant boulardii CNCM I-3799 (S. boulardii CNCM I-3799) in the management of acute diarrhea in children.
METHODS


A total of 100 infants and children aged 3-36 months with acute diarrhea received medical care according to the World Health Organization guidelines on the management of acute diarrhea in children and were randomly allocated to the probiotic group (S. boulardii CNCM I-3799 at a daily dose of 5 billion CFU twice daily) or to the placebo group. Infants and children were treated for 5 days and an extended follow-up was planned 1 and 2 months after the end of the treatment period. Primary endpoint was the time of recovery from diarrhea defined as the duration of diarrhea. Other parameters, such as frequency and consistency of stools, associated with the severity of diarrhea episodes were defined as secondary endpoints.
RESULTS


The administration of S. boulardii CNCM I-3799 was associated with beneficial effects on duration and severity of diarrhea. The time of recovery from diarrhea was significantly shorter in the probiotic group compared with the placebo group (65.8 ± 12 hours vs. 95.3 ± 17.6 hours, P = 0.0001). Faster remission in the probiotic group was also demonstrated by a shorter time before the first episode of semisolid stool [-23.5 hours, diff (95% CI): -7.99 (-31.49 to -15.51), P = 0.0001] and the faster normalization of stool consistency. S. boulardii CNCM I-3799 was well tolerated.
CONCLUSION


S. boulardii CNCM I-3799 supplementation in children with acute diarrhea was shown effective in reducing the duration and severity of diarrhea in infants and children.",2020,The administration of S. boulardii CNCM I-3799 was associated with beneficial effects on duration and severity of diarrhea.,"['Infants and Children With Acute Diarrhea', '100 infants and children aged 3-36 months with acute diarrhea received medical care according to the World Health Organization guidelines on the management of acute diarrhea in children', 'acute diarrhea in children', 'children with acute diarrhea']","['Saccharomyces boulardii', 'Placebo', 'S. boulardii CNCM I-3799 supplementation', 'Saccharomyces cerevisiae variant boulardii CNCM I-3799 (S. boulardii CNCM I-3799', 'probiotic group (S. boulardii CNCM I-3799', 'placebo']","['faster normalization of stool consistency', 'time of recovery from diarrhea defined as the duration of diarrhea', 'severity of diarrhea episodes', 'tolerated', 'frequency and consistency of stools', 'time of recovery from diarrhea', 'Faster remission', 'duration and severity of diarrhea']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0772093', 'cui_str': 'Saccharomyces boulardii'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",100.0,0.251802,The administration of S. boulardii CNCM I-3799 was associated with beneficial effects on duration and severity of diarrhea.,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Mourey', 'Affiliation': 'From the Research & Applications, Gnosis by Lesaffre, Lesaffre International, Marcq-en-Barœul, France.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Sureja', 'Affiliation': 'Sundyota Numandis Probioceuticals Pvt. Ltd.'}, {'ForeName': 'Dharmeshkumar', 'Initials': 'D', 'LastName': 'Kheni', 'Affiliation': 'Sundyota Numandis Probioceuticals Pvt. Ltd.'}, {'ForeName': 'Parthiv', 'Initials': 'P', 'LastName': 'Shah', 'Affiliation': 'Hitarth Children Hospital.'}, {'ForeName': 'Devang', 'Initials': 'D', 'LastName': 'Parikh', 'Affiliation': 'Bakeri Medical Research Centre.'}, {'ForeName': 'Unmesh', 'Initials': 'U', 'LastName': 'Upadhyay', 'Affiliation': 'Iqra Hospital.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Satia', 'Affiliation': 'Ethicare Clinical Trial Services, Ahmedabad, India.'}, {'ForeName': 'Dhara', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': 'Ethicare Clinical Trial Services, Ahmedabad, India.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Troise', 'Affiliation': 'From the Research & Applications, Gnosis by Lesaffre, Lesaffre International, Marcq-en-Barœul, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Decherf', 'Affiliation': 'From the Research & Applications, Gnosis by Lesaffre, Lesaffre International, Marcq-en-Barœul, France.'}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002849']
2012,32796410,Long-Term Efficacy of Treatment Effects After a Kyphosis Exercise and Posture Training Intervention in Older Community-Dwelling Adults: A Cohort Study.,"BACKGROUND AND PURPOSE


Treatments that prevent worsening kyphosis are important due to the progressive nature of kyphosis with aging. We assessed long-term efficacy of treatment effects after a short-term kyphosis exercise and posture training intervention in a cohort study among older adults with hyperkyphosis, and investigated whether long-term treatment effects differ among males and females.
METHODS


In the original kyphosis intervention, 112 older adults enrolled in a waitlist design randomized controlled trial. One hundred three participants, mean age 70.0 (5.7) years and kyphosis 52.0° (7.4°), completed a twice weekly, 3-month, group exercise and posture training intervention, and were eligible to enroll in the follow-up study. We compared (1) change in outcomes pre-/postintervention to change postintervention over the follow-up period, (2) change in outcomes pre-/postintervention and postintervention to follow-up, stratified by sex, and (3) long-term change postintervention to follow-up in males and females. Primary outcome was change in kyphometer-measured thoracic kyphosis. Secondary outcomes were change in lumbar lordosis, objective measures of physical function, self-reported measures of physical activity, and health-related quality of life (HRQoL).
RESULTS AND DISCUSSION


Forty-three participants, 42% of the eligible cohort, returned for follow-up, a mean 3.0 (0.7) years after completing the original intervention. Participants (27 females and 16 males) were 73.8 (6.1) years old, with mean kyphosis 48.9° (11.9°) at follow-up. Kyphosis declined -1.5° (95% confidence interval [CI]: -3.9° to 1.0°) postintervention to follow-up and this was no different than change pre-/postintervention, P = .173. Lordosis improved 8.9° (95% CI: 6.2° to 11.6°), more than change pre-/postintervention, P < .001. Gait speed measure of physical function increased 0.08 (95% CI: 0.02 to 0.14) m/s, Physical Activity Scale for the Elderly (PASE) measure of physical activity increased 4 (95% CI: -16 to 24) points, and Patient-Reported Outcomes Measurement Information System (PROMIS) mental health T-score measure of HRQoL increased 1.1 (95% CI: -1.0 to 3.1) points, but these improvements were not significantly more than change pre-/postintervention, P > .050. Other measures of physical function (modified Physical Performance Test [PPT], Timed Up and Go, and 6-minute walk) and HRQoL (Scoliosis Research Society [SRS-30] self-image and PROMIS physical function and physical health) declined at follow-up, significantly more than change pre/postintervention, P ≤ .050. Comparing change in outcomes pre-/postintervention and postintervention to follow-up, stratified by sex, both males and females increased lordosis, and decreased modified PPT and 6-minute walk measures of physical function, P < .050. Males and females differed in long-term change postintervention to follow-up. Time loaded standing and PASE improved in females compared with males, P = .008 and P = .092, respectively, and PROMIS mental health, physical health, and physical function declined in females compared with males, P = .073, P = .025, and P = .005, respectively.
CONCLUSIONS


In our follow-up study, a mean of 3.0 (0.07) years after a 3-month kyphosis exercise and posture training intervention, kyphosis maintained and did not progress as expected with age. There was long-term improvement in lordosis. Compared with treatment effects from the short-term intervention, gait speed maintained equally well in males and females, while trunk endurance improved in females. Further investigation of long-term benefits of a short-term kyphosis exercise and posture training intervention is warranted.",2020,"Time loaded standing and PASE improved in females compared with males, P = .008 and P = .092, respectively, and PROMIS mental health, physical health, and physical function declined in females compared with males, P = .073, P = .025, and P = .005, respectively.
","['Participants (27 females and 16 males) were 73.8 (6.1) years old, with mean kyphosis 48.9° (11.9°) at follow-up', 'One hundred three participants, mean age 70.0 (5.7) years and kyphosis 52.0° (7.4°', 'Forty-three participants, 42% of the eligible cohort, returned for follow-up, a mean 3.0 (0.7) years after completing the original intervention', 'Older Community-Dwelling Adults', 'older adults with hyperkyphosis', 'males and females', '112 older adults enrolled']","['Kyphosis Exercise and Posture Training Intervention', 'exercise and posture training intervention', 'short-term kyphosis exercise and posture training intervention']","['gait speed maintained equally well in males and females, while trunk endurance', 'PROMIS mental health, physical health, and physical function', 'Time loaded standing and PASE', 'Physical Activity Scale for the Elderly (PASE) measure of physical activity', 'Lordosis', 'modified PPT and 6-minute walk measures of physical function', 'mental health T-score measure of HRQoL', 'physical function (modified Physical Performance Test [PPT], Timed Up and Go, and 6-minute walk) and HRQoL (Scoliosis Research Society [SRS-30] self-image and PROMIS physical function and physical health', 'lordosis', 'change in kyphometer-measured thoracic kyphosis', 'change in lumbar lordosis, objective measures of physical function, self-reported measures of physical activity, and health-related quality of life (HRQoL', 'Gait speed measure of physical function', 'Outcomes Measurement Information System (PROMIS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0454282', 'cui_str': 'Posture training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024003', 'cui_str': 'Lordosis accentuated'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036439', 'cui_str': 'Scoliosis deformity of spine'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0175693', 'cui_str': 'Russell-Silver syndrome'}, {'cui': 'C0242498', 'cui_str': 'Self-image'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0022821', 'cui_str': 'Kyphosis deformity of spine'}, {'cui': 'C1184923', 'cui_str': 'Lumbar hyperlordosis'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}]",103.0,0.0680831,"Time loaded standing and PASE improved in females compared with males, P = .008 and P = .092, respectively, and PROMIS mental health, physical health, and physical function declined in females compared with males, P = .073, P = .025, and P = .005, respectively.
","[{'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'Katzman', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of California, San Francisco.'}, {'ForeName': 'Neeta', 'Initials': 'N', 'LastName': 'Parimi', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of California, San Francisco.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Gladin', 'Affiliation': 'Rehabilitation Services, Kaiser Permanente San Francisco Medical Center, California.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of California, San Francisco.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Lane', 'Affiliation': 'Department of Medicine, University of California, Davis.'}]",Journal of geriatric physical therapy (2001),['10.1519/JPT.0000000000000262']
2013,32796413,"Ergogenic Effects of Photobiomodulation on Performance in the 30-Second Wingate Test: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study.","Molina Correa, JC, Padoin, S, Varoni, PR, Demarchi, MC, Flores, LJ, Nampo, FK, and de Paula Ramos, S. Ergogenic effects of photobiomodulation on performance in the 30-second Wingate test: A randomized, double-blind, placebo-controlled, crossover study. J Strength Cond Res XX(X): 000-000, 2020-The purpose of this study was to evaluate the ergogenic effects of red light (630 nm) photobiomodulation on anaerobic capacity in the Wingate test. Sixteen healthy and physically active male volunteers (21.71 ± 2.49 years of age, body mass index between 18.5 and 24.9 kg/m) participated in this randomized, double-blind, placebo-controlled, crossover study. The subjects performed 3 Wingate test sessions, with a 48-hour interval between tests. In the first session (baseline session, BS), a Wingate test was performed to evaluate the initial performance. Subjects were paired by performance in the BS and allocated through a draw to receive either the phototherapy (630 nm, 4.6 J/cm, 6 J per point, 16 points, light-emitting diode [LED] session) or placebo intervention (PLA session) in the second test session. In the third test session, a crossover intervention was performed. The repeated-measures analysis of variance test, followed by Bonferroni post hoc test or Friedman test with Dunn's post hoc test (p < 0.05) and Cohen's d statistic were used for comparisons. The LED session with phototherapy promoted an increase in performance in peak power (p < 0.05), relative power (p < 0.05), RPMpeak (p < 0.05), and peak velocity (p < 0.05), as well as total displacement (p < 0.01) compared with PLA. The mean power (p < 0.05), relative power (p < 0.05), RPMmean (p < 0.01), and mean velocity (p < 0.01) were higher in the LED session than those of BS. We concluded that phototherapy improves performance in Wingate anaerobic exercise, possibly due to large effects on the anaerobic alactic metabolism.",2020,"The LED session with phototherapy promoted an increase in performance in peak power (p < 0.05), relative power (p < 0.05), RPMpeak (p < 0.05), and peak velocity (p < 0.05), as well as total displacement (p < 0.01) compared with PLA.","['Sixteen healthy and physically active male volunteers (21.71 ± 2.49 years of age, body mass index between 18.5 and 24.9 kg/m']","['J Strength Cond Res XX(X', 'Placebo', 'phototherapy', 'red light (630 nm) photobiomodulation', 'placebo intervention (PLA session', 'Photobiomodulation', 'placebo']","['peak velocity', 'mean power', 'total displacement', 'performance in peak power', 'Molina Correa, JC, Padoin, S, Varoni, PR, Demarchi, MC, Flores, LJ, Nampo, FK, and de Paula Ramos, S. Ergogenic effects', 'anaerobic capacity', 'mean velocity', 'relative power']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C4708661', 'cui_str': '2.49'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517611', 'cui_str': '18.5'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0563227', 'cui_str': 'Red light'}, {'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0454740', 'cui_str': 'Flores'}, {'cui': 'C3178747', 'cui_str': 'Performance-Enhancing Effects'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",16.0,0.439235,"The LED session with phototherapy promoted an increase in performance in peak power (p < 0.05), relative power (p < 0.05), RPMpeak (p < 0.05), and peak velocity (p < 0.05), as well as total displacement (p < 0.01) compared with PLA.","[{'ForeName': 'Julio C', 'Initials': 'JC', 'LastName': 'Molina Correa', 'Affiliation': 'State University of Londrina, Londrina, Paraná, Brazil.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Padoin', 'Affiliation': 'State University of Londrina, Londrina, Paraná, Brazil.'}, {'ForeName': 'Pedro R', 'Initials': 'PR', 'LastName': 'Varoni', 'Affiliation': 'Department of Physical Education, State University of Western Paraná, Campus de Marechal Cândido Rondon, Marechal Cândido Rondon, Paraná, Brazil.'}, {'ForeName': 'Michelli C', 'Initials': 'MC', 'LastName': 'Demarchi', 'Affiliation': 'Department of Physical Education, State University of Western Paraná, Campus de Marechal Cândido Rondon, Marechal Cândido Rondon, Paraná, Brazil.'}, {'ForeName': 'Lucinar J F', 'Initials': 'LJF', 'LastName': 'Flores', 'Affiliation': 'Research Group in Tissue Regeneration, Adaptation, and Repair, State University of Londrina, Londrina, Paraná, Brazil.'}, {'ForeName': 'Fernando K', 'Initials': 'FK', 'LastName': 'Nampo', 'Affiliation': 'Latin American Institute of Science of Life and Nature, Federal University of Latin American Integration, Foz do Iguaçu, Paraná, Brazil.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'de Paula Ramos', 'Affiliation': 'Research Group in Tissue Regeneration, Adaptation, and Repair, State University of Londrina, Londrina, Paraná, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003734']
2014,32796417,Effects of Integrative Neuromuscular Training on Motor Performance in Prepubertal Soccer Players.,"Menezes, GB, Alexandre, DR, Pinto, JC, Assis, TV, Faigenbaum, AD, and Mortatti, AL. Effects of integrative neuromuscular training on motor performance in prepubertal soccer players. J Strength Cond Res XX(X): 000-000, 2020-The present study examined the effects of integrative neuromuscular training (INT) on motor performance in prepubertal soccer players. Subjects were randomly assigned to the experimental group (INT; n = 20, age: 8.2 ± 1.2 years; body mass: 28.4 ± 6.4 kg; height: 1.3 ± 0.1 m) or the control group (CON; n = 18, age: 8.5 ± 1.3 years; body mass: 32.8 ± 8.9 kg; height: 1.3 ± 0.1 m). Integrative neuromuscular training program was performed twice per week during the 12-week training intervention. Balance, flexibility, countermovement vertical jump height (CVJH), sprint speed, and change of direction speed (CODS) were assessed in both groups at baseline, sixth week and 12th week. A mixed model repeated measures analysis of variance was used to examine the group changes in performance for each variable. There was a time effect for balance in the INT from pre to 12th weeks (p < 0.001, g = 0.72), and from 6th to 12th weeks (p = 0.005, g = 0.34). An interaction effect for balance was also observed between INT and CON after the 12th week. A time effect in flexibility was observed in INT from baseline to 6th and 12th weeks (p = 0.02; g = 0.45 and p < 0.001; g = 0.71) and from 6 to 12th weeks (p = 0.003; g = 0.24). There was a time effect in CVJH, from baseline to 12th week and from 6th to 12th weeks (p < 0.05; g = 0.34 and g = 0.53, respectively). There was no significant between-group speed performance change. A time effect was found in CODS in INT, but only from baseline to 12th week (p = 0.02; g = 0.31). There were significant improvements in the percent change (Δ%) from baseline to 12 weeks (p < 0.05) for balance, flexibility, and CVJH in INT. These findings indicate that the addition of an INT program to soccer practice can improve selected motor performance skills in prepubertal soccer players.",2020,"There were significant improvements in the percent change (Δ%) from baseline to 12 weeks (p < 0.05) for balance, flexibility, and CVJH in INT.","[' 000-000', 'prepubertal soccer players', 'Prepubertal Soccer Players']","['integrative neuromuscular training', 'J Strength Cond Res XX(X', 'Integrative Neuromuscular Training', 'Integrative neuromuscular training program', 'integrative neuromuscular training (INT']","['Motor Performance', 'selected motor performance skills', 'flexibility', 'Menezes, GB, Alexandre, DR, Pinto, JC, Assis, TV, Faigenbaum, AD, and Mortatti, AL', 'Balance, flexibility, countermovement vertical jump height (CVJH), sprint speed, and change of direction speed (CODS', 'balance, flexibility, and CVJH in INT', 'motor performance']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0324179', 'cui_str': 'Pinto'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",20.0,0.0234106,"There were significant improvements in the percent change (Δ%) from baseline to 12 weeks (p < 0.05) for balance, flexibility, and CVJH in INT.","[{'ForeName': 'Glauber B', 'Initials': 'GB', 'LastName': 'Menezes', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Brazil.'}, {'ForeName': 'Diego R O', 'Initials': 'DRO', 'LastName': 'Alexandre', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Brazil.'}, {'ForeName': 'Júlio C B L', 'Initials': 'JCBL', 'LastName': 'Pinto', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Brazil.'}, {'ForeName': 'Tereza V L', 'Initials': 'TVL', 'LastName': 'Assis', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Brazil.'}, {'ForeName': 'Avery D', 'Initials': 'AD', 'LastName': 'Faigenbaum', 'Affiliation': 'Department of Health and Exercise Science, College of New Jersey, Ewing, New Jersey.'}, {'ForeName': 'Arnaldo L', 'Initials': 'AL', 'LastName': 'Mortatti', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003666']
2015,32796630,Effects of 12-Week Methylphenidate Treatment on Neurometabolism in Adult Patients with ADHD: The First Double-Blind Placebo-Controlled MR Spectroscopy Study.,"Attention deficit hyperactivity disorder (ADHD) is a frequent neurodevelopmental disorder that often persists into adulthood. Methylphenidate (MPH) is the first-line treatment for ADHD; however, despite its wide usage, little is known about its neurometabolic effects. Until now, no randomized and blinded clinical trials have been conducted addressing the neurometabolic signals of MPH administration in adults with ADHD. In the current study, the authors investigated how MPH intake and group psychotherapy (GPT) influence brain neurometabolism over the course of three months. The authors hypothesized a decrease in the anterior cingulate cortex (ACC) glutamate concentration following MPH administration. This study was part of a double-blind multicenter trial (Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS)) investigating the effects of MPH and GPT in patients with adult ADHD. Using single-voxel magnetic resonance spectroscopy (MRS) of the pregenual ACC and the left cerebellar hemisphere (CHL), we investigated the concentration of glutamate plus glutamine (Glx), N-acetyl-aspartate, creatine, total choline containing compounds, and myo-inositol in patients before and after 12 weeks of treatment. Neither MPH nor GPT significantly influenced the Glx concentration or any of the other metabolite concentrations in the ACC and CHL after 12 weeks. Therefore, contrary to the hypothesis, no change in the prefrontal Glx signal was detected after MPH treatment. Given that MRS does not differentiate between glutamate in the synaptic cleft and in neuronal tissue, MPH-induced down-regulation of glutamatergic neurotransmission in the ACC might only affect the concentration of glutamate in the synaptic cleft, while the general availability of glutamate in the respective neuronal tissue might be unaffected by MPH intake. The observed lack of any MPH-induced normalization in metabolite concentrations is less surprising, considering that the baseline sample did not significantly differ from a healthy control group. Future studies of other regions, such as the basal ganglia, and the use of novel methods, such as whole brain MRS and multimodal imaging approaches, are necessary.",2020,Neither MPH nor GPT significantly influenced the Glx concentration or any of the other metabolite concentrations in the ACC and CHL after 12 weeks.,"['Adult Patients with ADHD', 'adults with ADHD', 'patients with adult ADHD']","['Methylphenidate and Psychotherapy', 'MRS', 'Placebo', 'MPH and GPT', 'Methylphenidate', 'MPH intake and group psychotherapy (GPT', 'Methylphenidate (MPH', 'single-voxel magnetic resonance spectroscopy (MRS']","['concentration of glutamate plus glutamine (Glx), N-acetyl-aspartate, creatine, total choline containing compounds, and myo-inositol', 'metabolite concentrations', 'prefrontal Glx signal', 'anterior cingulate cortex (ACC) glutamate concentration', 'Glx concentration']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0865424', 'cui_str': 'Adult attention deficit hyperactivity disorder'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0037179', 'cui_str': 'Single person'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0067684', 'cui_str': 'N-acetyl-L-aspartate'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0021547', 'cui_str': 'Inositol'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}]",,0.105742,Neither MPH nor GPT significantly influenced the Glx concentration or any of the other metabolite concentrations in the ACC and CHL after 12 weeks.,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Maier', 'Affiliation': 'Section for Experimental Neuropsychiatry, Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79104 Freiburg, Germany.'}, {'ForeName': 'Ludger', 'Initials': 'L', 'LastName': 'Tebartz van Elst', 'Affiliation': 'Section for Experimental Neuropsychiatry, Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79104 Freiburg, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Philipsen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Bonn, 53105 Bonn, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lange', 'Affiliation': 'Department of Radiology, Medical Physics, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Feige', 'Affiliation': 'Section for Experimental Neuropsychiatry, Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79104 Freiburg, Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Glauche', 'Affiliation': 'Department of Neurology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79106 Freiburg, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Nickel', 'Affiliation': 'Section for Experimental Neuropsychiatry, Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79104 Freiburg, Germany.'}, {'ForeName': 'Swantje', 'Initials': 'S', 'LastName': 'Matthies', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79104 Freiburg, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Alm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty of Mannheim, University of Heidelberg, 68159 Mannheim, Germany.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Sobanski', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty of Mannheim, University of Heidelberg, 68159 Mannheim, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Domschke', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79104 Freiburg, Germany.'}, {'ForeName': 'Evgeniy', 'Initials': 'E', 'LastName': 'Perlov', 'Affiliation': 'Section for Experimental Neuropsychiatry, Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79104 Freiburg, Germany.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Endres', 'Affiliation': 'Section for Experimental Neuropsychiatry, Department of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, 79104 Freiburg, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9082601']
2016,32796734,Design and Validation of a Diet Rich in Slowly Digestible Starch for Type 2 Diabetic Patients for Significant Improvement in Glycemic Profile.,"This study aimed at designing a-diet high in slowly digestible starch (SDS) by carefully selecting high-SDS starchy products and to validate its implementation, acceptance, and impact on the postprandial glycemic response in patients with type 2 diabetes (T2D). Starchy products were screened and classified as being either high (high-SDS) or low (low-SDS) in SDS (in vitro SDS method). A randomized controlled cross-over pilot study was performed: Eight patients with T2D consumed randomly a high-SDS or a low-SDS diet for one week each, while their glycemic profile was monitored for 6 days. Based on 250 food product SDS analyses and dietary recommendations for patients with T2D, the high-SDS and low-SDS diets were designed. The high-SDS diet significantly increased SDS intake and the SDS/carbohydrates proportion compared to the low-SDS diet (61.6 vs. 11.6 g/day and 30% vs. 6%;  p  < 0.0001, respectively). Increasing the SDS/carbohydrate proportion to 50% of the meal was significantly correlated with a 12% decrease in tAUC0-120 min and a 14% decrease in the glycemic peak value ( p  < 0.001 for both). A high-SDS diet can be easily designed by carefully selecting commercial starchy products and providing relevant recommendations for T2D to improve their glycemic profile.",2020,The high-SDS diet significantly increased SDS intake and the SDS/carbohydrates proportion compared to the low-SDS diet (61.6 vs. 11.6 g/day and 30% vs. 6%;  ,"['patients with T2D, the high-SDS and low-SDS diets', 'Eight patients with T2D consumed randomly a high-SDS or a', 'patients with type 2 diabetes (T2D']","['low-SDS diet', 'diet high in slowly digestible starch (SDS']","['SDS/carbohydrate proportion', 'glycemic peak value', 'Glycemic Profile', 'postprandial glycemic response', 'SDS intake and the SDS/carbohydrates proportion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]",8.0,0.0165172,The high-SDS diet significantly increased SDS intake and the SDS/carbohydrates proportion compared to the low-SDS diet (61.6 vs. 11.6 g/day and 30% vs. 6%;  ,"[{'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Goux', 'Affiliation': 'Nutrition Research, Mondelēz International, 91400 Saclay, France.'}, {'ForeName': 'Anne-Esther', 'Initials': 'AE', 'LastName': 'Breyton', 'Affiliation': 'Nutrition Research, Mondelēz International, 91400 Saclay, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Meynier', 'Affiliation': 'Nutrition Research, Mondelēz International, 91400 Saclay, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Lambert-Porcheron', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, F-CRIN/FORCE Network, 69100 Pierre Bénite, France.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Sothier', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, F-CRIN/FORCE Network, 69100 Pierre Bénite, France.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Van Den Berghe', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, F-CRIN/FORCE Network, 69100 Pierre Bénite, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Brack', 'Affiliation': 'Statistique Industrielle KHI2 Consulting (KSIC), 60110 Esches, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Normand', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, F-CRIN/FORCE Network, 69100 Pierre Bénite, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Disse', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, F-CRIN/FORCE Network, 69100 Pierre Bénite, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Laville', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, F-CRIN/FORCE Network, 69100 Pierre Bénite, France.'}, {'ForeName': 'Julie-Anne', 'Initials': 'JA', 'LastName': 'Nazare', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes, Univ-Lyon, CarMeN Laboratory, Université Claude Bernard Lyon1, Hospices Civils de Lyon, F-CRIN/FORCE Network, 69100 Pierre Bénite, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Vinoy', 'Affiliation': 'Nutrition Research, Mondelēz International, 91400 Saclay, France.'}]",Nutrients,['10.3390/nu12082404']
2017,32785636,Assessment of Relationship of Ketamine Dose With Magnetic Resonance Spectroscopy of Glx and GABA Responses in Adults With Major Depression: A Randomized Clinical Trial.,"Importance


A single subanesthetic dose of ketamine produces an antidepressant response in patients with major depressive disorder (MDD) within hours, but the mechanism of antidepressant effect is uncertain.
Objective


To evaluate whether ketamine dose and brain glutamate and glutamine (Glx) and γ-aminobutyric acid (GABA) level responses to ketamine are related to antidepressant benefit and adverse effects.
Design, Setting, and Participants


This randomized, parallel-group, triple-masked clinical trial included 38 physically healthy, psychotropic medication-free adult outpatients who were in a major depressive episode of MDD but not actively suicidal. The trial was conducted at Columbia University Medical Center. Data were collected from February 2012 to May 2015. Data analysis was conducted from January to March 2020.
Intervention


Participants received 1 dose of placebo or ketamine (0.1, 0.2, 0.3, 0.4, or 0.5 mg/kg) intravenously during 40 minutes of a proton magnetic resonance spectroscopy scan that measured ventro-medial prefrontal cortex Glx and GABA levels in 13-minute data frames.
Main Outcomes and Measures


Clinical improvement was measured using a 22-item version of the Hamilton Depression Rating Scale (HDRS-22) 24 hours after ketamine was administered. Ketamine and metabolite blood levels were measured after the scan.
Results


A total of 38 individuals participated in the study, with a mean (SD) age of 38.6 (11.2) years, 23 (60.5%) women, and 25 (65.8%) White patients. Improvement in HDRS-22 score at 24 hours correlated positively with ketamine dose (t36 = 2.81; P = .008; slope estimate, 19.80 [95% CI, 5.49 to 34.11]) and blood level (t36 = 2.25; P = .03; slope estimate, 0.070 [95% CI, 0.007 to 0.133]). The lower the Glx response, the better the antidepressant response (t33 = -2.400; P = .02; slope estimate, -9.85 [95% CI, -18.2 to -1.50]). Although GABA levels correlated with Glx (t33 = 8.117; P < .001; slope estimate, 0.510 [95% CI, 0.382 to 0.638]), GABA response did not correlate with antidepressant effect. When both ketamine dose and Glx response were included in a mediation analysis model, ketamine dose was no longer associated with antidepressant effect, indicating that Glx response mediated the relationship. Adverse effects were related to blood levels in men only (t5 = 2.606; P = .048; estimated slope, 0.093 [95% CI, 0.001 to 0.186]), but Glx and GABA response were not related to adverse effects.
Conclusions and Relevance


In this study, intravenous ketamine dose and blood levels correlated positively with antidepressant response. The Glx response correlated inversely with ketamine dose and with antidepressant effect. Future studies are needed to determine whether the relationship between Glx level and antidepressant effect is due to glutamate or glutamine.
Trial Registration


ClinicalTrials.gov Identifier: NCT01558063.",2020,"Adverse effects were related to blood levels in men only (t5 = 2.606; P = .048; estimated slope, 0.093 [95% CI, 0.001 to 0.186]), but Glx and GABA response were not related to adverse effects.
","['38 individuals participated in the study, with a mean (SD) age of 38.6 (11.2) years, 23 (60.5%) women, and 25 (65.8', '38 physically healthy, psychotropic medication-free adult outpatients who were in a major depressive episode of MDD but not actively suicidal', 'White patients', 'patients with major depressive disorder (MDD', 'Adults With Major Depression']","['placebo or ketamine', 'Ketamine Dose With Magnetic Resonance Spectroscopy of Glx and GABA Responses', 'ketamine']","['Glx and GABA response', 'Ketamine and metabolite blood levels', 'antidepressant response', 'blood levels', 'brain glutamate and glutamine (Glx) and γ-aminobutyric acid (GABA) level responses', 'Adverse effects', 'HDRS-22 score', 'GABA response', '22-item version of the Hamilton Depression Rating Scale (HDRS-22', 'blood level', 'Glx response']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033978', 'cui_str': 'Psychotherapeutic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0024517', 'cui_str': 'Major depression, single episode'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0024487', 'cui_str': 'Magnetic resonance spectroscopy'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}]","[{'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",38.0,0.370157,"Adverse effects were related to blood levels in men only (t5 = 2.606; P = .048; estimated slope, 0.093 [95% CI, 0.001 to 0.186]), but Glx and GABA response were not related to adverse effects.
","[{'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Milak', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Rain', 'Initials': 'R', 'LastName': 'Rashid', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Zhengchao', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Grunebaum', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'R Todd', 'Initials': 'RT', 'LastName': 'Ogden', 'Affiliation': 'Molecular Imaging and Neuropathology Division, The New York State Psychiatric Institute, New York.'}, {'ForeName': 'Xuejing', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Molecular Imaging and Neuropathology Division, The New York State Psychiatric Institute, New York.'}, {'ForeName': 'Stephanie T', 'Initials': 'ST', 'LastName': 'Mulhern', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Suckow', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Keilp', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Xiangling', 'Initials': 'X', 'LastName': 'Mao', 'Affiliation': 'Department of Radiology, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Dikoma C', 'Initials': 'DC', 'LastName': 'Shungu', 'Affiliation': 'Department of Radiology, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'J John', 'Initials': 'JJ', 'LastName': 'Mann', 'Affiliation': 'Department of Psychiatry, College of Physicians and Surgeons, Columbia University, New York, New York.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.13211']
2018,32787848,"Effects of vaginal administration of conjugated estrogens tablet on sexual function in postmenopausal women with sexual dysfunction: a double-blind, randomized, placebo-controlled trial.","BACKGROUND


Female sexual dysfunction (FSD) is prevalent in women with genitourinary syndrome of menopause (GSM). Vaginal estrogen is effective GSM treatment. This study was primarily aimed to evaluate the effects of vaginal administration of conjugated estrogens tablet on postmenopausal FSD using the Female Sexual Function Index (FSFI). Secondary aims were to evaluate vaginal pH, Vaginal Maturation Value (VMV), Normal Flora Index (NFI) and Most Bothersome Symptoms (MBS) changes.
METHODS


A double-blind trial was conducted in postmenopausal women with FSD (FSFI ≤26.55). Sixty-seven participants were randomized into two arms; vaginally administered conjugated estrogens tablet (0.625 mg, daily for 3 weeks then twice weekly for 9 weeks, n = 33), or placebo (n = 34).
RESULTS


There was no significant improvement of FSFI observed in estrogens arm compared to placebo in each domain and overall index (p = 0.182). The estrogens significantly improved vaginal pH and VMV, toward more acidity (p = < 0.001), higher VMV (p = < 0.001) and more superficial cells (p = < 0.001). We observed no significant difference in NFI and MBS between arms (p = 0.282, 0.182).
CONCLUSION


We found no significant changes in FSFI, NFI, and MBS, but significant improvement in vaginal pH and VMV in postmenopausal women with FSD treated with vaginally administered conjugated estrogens tablet. Few side-effects were reported.
TRIAL REGISTRATION


Thai Clinical Trial Registry identification number TCTR20180219001 , prospectively registered since 2018-02-19 11:33:21.",2020,"The estrogens significantly improved vaginal pH and VMV, toward more acidity (p = < 0.001), higher VMV (p = < 0.001) and more superficial cells (p = < 0.001).","['women with genitourinary syndrome of menopause (GSM', 'Sixty-seven participants', 'postmenopausal women with FSD (FSFI ≤26.55', 'postmenopausal women with FSD treated with vaginally administered', 'postmenopausal women with sexual dysfunction', 'postmenopausal FSD using the Female Sexual Function Index (FSFI']","['vaginal administration of conjugated estrogens tablet', 'vaginally administered conjugated estrogens tablet', 'conjugated estrogens tablet', 'placebo']","['FSFI, NFI, and MBS', 'superficial cells', 'FSFI', 'vaginal pH and VMV', 'sexual function', 'vaginal pH, Vaginal Maturation Value (VMV), Normal Flora Index (NFI) and Most Bothersome Symptoms (MBS) changes', 'vaginal pH and VMV, toward more acidity', 'NFI and MBS', 'higher VMV']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C5192371', 'cui_str': 'Genitourinary syndrome of menopause'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C1112442', 'cui_str': 'Female sexual dysfunction'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder'}]","[{'cui': 'C0001561', 'cui_str': 'Medication administration: vaginal'}, {'cui': 'C0014938', 'cui_str': 'Estrogens, Conjugated (USP)'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0314761', 'cui_str': 'Normal flora'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0205250', 'cui_str': 'High'}]",67.0,0.625373,"The estrogens significantly improved vaginal pH and VMV, toward more acidity (p = < 0.001), higher VMV (p = < 0.001) and more superficial cells (p = < 0.001).","[{'ForeName': 'Thanapob', 'Initials': 'T', 'LastName': 'Bumphenkiatikul', 'Affiliation': 'Division of Reproductive Medicine, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Road, Bangkok, 10330, Thailand. thanapob@chula.md.'}, {'ForeName': 'Krasean', 'Initials': 'K', 'LastName': 'Panyakhamlerd', 'Affiliation': 'Division of Reproductive Medicine, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Road, Bangkok, 10330, Thailand.'}, {'ForeName': 'Thanittha', 'Initials': 'T', 'LastName': 'Chatsuwan', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Chai', 'Initials': 'C', 'LastName': 'Ariyasriwatana', 'Affiliation': 'Division of Gynecologic Cyto-Pathology, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, 10330, Thailand.'}, {'ForeName': 'Ammarin', 'Initials': 'A', 'LastName': 'Suwan', 'Affiliation': 'Division of Reproductive Medicine, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Road, Bangkok, 10330, Thailand.'}, {'ForeName': 'Charoen', 'Initials': 'C', 'LastName': 'Taweepolcharoen', 'Affiliation': 'Division of Reproductive Medicine, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, 1873 Rama IV Road, Bangkok, 10330, Thailand.'}, {'ForeName': 'Nimit', 'Initials': 'N', 'LastName': 'Taechakraichana', 'Affiliation': 'Department of Medical Education and Clinical Research Center, Bumrungrad International Hospital, Bangkok, 10110, Thailand.'}]",BMC women's health,['10.1186/s12905-020-01031-4']
2019,31820334,Effect of Smartphone-Based Telemonitored Exercise Rehabilitation among Patients with Coronary Heart Disease.,"The aim of this study was to investigate the effects of telemonitored exercise rehabilitation on patients with coronary heart disease (CHD) in China. Ninety-six patients with stable CHD were included and analyzed (48 in telemonitored group and 48 in control group). All patients received routine follow-up, and patients in telemonitored group participated in smartphone-based telemonitored cardiac rehabilitation. Patients' demographic information, medical history, diagnosis and treatment of CHD, and laboratory results were collected. The difference of cardiopulmonary exercise testing (CPET), blood test, and echocardiographic parameters; exercise habits; control rate of blood lipid and blood glucose; and incidence of adverse events between the two groups during 6 months of follow-up was analyzed. After intervention, the subjects in the telemonitored group performed significantly better in VO 2peak , exercise compliance, and some other parameters than those in the control group. Telemonitored exercise rehabilitation is an effective rehabilitation mode for CHD patients in China.",2020,"After intervention, the subjects in the telemonitored group performed significantly better in VO 2peak , exercise compliance, and some other parameters than those in the control group.","['CHD patients in China', 'patients with coronary heart disease (CHD) in China', 'Ninety-six patients with stable CHD', 'Patients with Coronary Heart Disease']","['Smartphone-Based Telemonitored Exercise Rehabilitation', 'smartphone-based telemonitored cardiac rehabilitation', 'Telemonitored exercise rehabilitation', 'telemonitored exercise rehabilitation']","['cardiopulmonary exercise testing (CPET), blood test, and echocardiographic parameters; exercise habits; control rate of blood lipid and blood glucose; and incidence of adverse events', 'VO 2peak , exercise compliance']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",96.0,0.0186907,"After intervention, the subjects in the telemonitored group performed significantly better in VO 2peak , exercise compliance, and some other parameters than those in the control group.","[{'ForeName': 'Yanxin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing, 100191, China.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': 'Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing, 100191, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing, 100191, China.'}, {'ForeName': 'Liyuan', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing, 100191, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing, 100191, China. beate_vv@bjmu.edu.cn.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology and Institute of Vascular Medicine, Peking University Third Hospital, NHC Key Laboratory of Cardiovascular Molecular Biology and Regulatory Peptides, Key Laboratory of Molecular Cardiovascular Science, Ministry of Education, Beijing Key Laboratory of Cardiovascular Receptors Research, Beijing, 100191, China.'}]",Journal of cardiovascular translational research,['10.1007/s12265-019-09938-6']
2020,32792737,Efficacy of ultrasound guided quadratus lumborum block as postoperative analgesia in renal transplantation recipients: A randomised double blind clinical study.,"Background and Aims


Postoperative pain following renal transplantation is moderate to severe. Quadratus lumborum block (QLB) is a new block that can provide effective analgesia following abdominal and retroperitoneal surgeries. This study aimed to evaluate the analgesic efficacy of QLB for postoperative analgesia in patients undergoing renal transplantation.
Methods


Patients were randomised into two groups of 30 each. In group A (block group), 20 mL of 0.25% bupivacaine and group B (placebo group), 20 mLof normal saline were injected. In the postoperative room, an intravenous patient controlled analgesia (IVPCA) pump with fentanyl was started in both the group. The postoperatively recorded parameters were numerical rating scale (NRS) pain score at rest and on movement and coughing, total fentanyl consumption, sedation score, postoperative nausea vomiting, limb weakness, paralytic ileus, and any other block-related complication. Data were analysed using SPSS software version 22.0. Categorical data were analysed using the Chi-square method. Student t test or Mann-Whitney U test was applied for the continuous data. Numerical data with normal distribution were displayed as mean (standard deviation), abnormal distribution was displayed in the median (interquartile range) values, and as a percentage for categorical variables.
Results


Fentanyl consumption, numerical rating score, and sedation score were significantly less in group A when compared to group B at 1, 4, 8, 12, and 24 h ( P  < 0.001).
Conclusion


Type-1 QLB significantly reduces fentanyl consumption and NRS pain score at 1,4,8,12, and 24 h in the postoperative period in renal transplant recipients.",2020,"Results


Fentanyl consumption, numerical rating score, and sedation score were significantly less in group A when compared to group B at 1, 4, 8, 12, and 24 h ( P  < 0.001).
","['renal transplantation recipients', 'renal transplant recipients', 'patients undergoing renal transplantation']","['QLB', 'Quadratus lumborum block (QLB', 'bupivacaine and group B (placebo', 'intravenous patient controlled analgesia (IVPCA) pump with fentanyl', 'ultrasound guided quadratus lumborum block']","['analgesic efficacy', 'fentanyl consumption and NRS pain score', 'Fentanyl consumption, numerical rating score, and sedation score', 'numerical rating scale (NRS) pain score at rest and on movement and coughing, total fentanyl consumption, sedation score, postoperative nausea vomiting, limb weakness, paralytic ileus, and any other block-related complication']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0520904', 'cui_str': 'Postoperative nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0587246', 'cui_str': 'Muscle weakness of limb'}, {'cui': 'C0030446', 'cui_str': 'Paralytic ileus'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.173631,"Results


Fentanyl consumption, numerical rating score, and sedation score were significantly less in group A when compared to group B at 1, 4, 8, 12, and 24 h ( P  < 0.001).
","[{'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sindwani', 'Affiliation': 'Department of Anaesthesiology, ILBS, New Delhi, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Sahu', 'Affiliation': 'Department of Anaesthesiology, SGPGIMS, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Aditi', 'Initials': 'A', 'LastName': 'Suri', 'Affiliation': 'Department of Oncoanesthesia, AIIMS, New Delhi, India.'}, {'ForeName': 'Sanjoy', 'Initials': 'S', 'LastName': 'Sureka', 'Affiliation': 'Department of Urology and Renal Transplantation, SGPGIMS, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Thomas', 'Affiliation': 'Department of Anaesthesiology, ILBS, New Delhi, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_21_20']
2021,32792739,"A prospective randomised trial to compare three insertion techniques for i-gel™ placement: Standard, reverse, and rotation.","Background and Aims


This prospective randomised study was done to compare standard, reverse, and rotation techniques of i-gel™ placement in terms of insertion characteristics and success rate.
Material and Methods


After institutional ethics committee approval, 135 patients aged 18-50 years, ASA I and II undergoing elective surgery under general anesthesia were included. After induction of anesthesia, i-gel™ was inserted by standard, reverse, and rotation technique in Groups I, II, and III, respectively. The primary objective was mean time of insertion. Secondary variables included ease of insertion, first attempt success rate, manoeuvres required, fiberoptic view of placement, oropharyngeal leak pressure, ease of placement of nasogastric tube, and complications if any.
Results


Mean time of insertion was 18.04 ± 5.65 s, 15.00 ± 5.72 s and 16.12 ± 5.84 s for groups I, II, and III, respectively. Time taken for insertion was shortest and significantly lower ( P  = 0.048) for group II compared to group I. Insertion time was comparable between rest of groups. The overall success rate in groups I, II, and III were 91.1%, 95.6%, and 93.3% respectively ( P  = 0.7). The first attempt success rate was 82.2%, 89%, and 84.4% in groups I, II and III, respectively ( P  = 0.07). Manoeuvres were required in five (12.19%) patients in group I, four (9.30%) patients in group II, and three (7.14%) patients in group III ( P  = 0.602). Complications occurred in eight, three, and three patients in groups I, II, and III, respectively.
Conclusion


All techniques of i-gel insertion are equally good and choice of technique depends upon the experience and comfort of the investigator with the particular technique.",2020,Time taken for insertion was shortest and significantly lower ( P  = 0.048) for group II compared to group I. Insertion time was comparable between rest of groups.,"['135 patients aged 18-50 years, ASA I and II undergoing elective surgery under general anesthesia were included']",[],"['Time taken for insertion', 'overall success rate', 'ease of insertion, first attempt success rate, manoeuvres required, fiberoptic view of placement, oropharyngeal leak pressure, ease of placement of nasogastric tube, and complications if any', 'Complications', 'Mean time of insertion', 'success rate', 'mean time of insertion']","[{'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",135.0,0.0240024,Time taken for insertion was shortest and significantly lower ( P  = 0.048) for group II compared to group I. Insertion time was comparable between rest of groups.,"[{'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Bhardwaj', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. BD Sharma University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Suresh K', 'Initials': 'SK', 'LastName': 'Singhal', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. BD Sharma University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Rashmi', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. BD Sharma University of Health Sciences, Rohtak, Haryana, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Dahiya', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Pt. BD Sharma University of Health Sciences, Rohtak, Haryana, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_937_19']
2022,32792757,Effectiveness of Misoprostol in Office Hysteroscopy in Premenopausal Nulliparous Women: A Prospective Randomized Double-Blind Placebo-Controlled Trial.,"Study Objective


The objective of this was to evaluate the effectiveness of misoprostol in premenopausal nulliparous women with 200-mcg single vaginal dose 4 h before the procedure.
Design


This was a prospective randomized double-blind placebo-controlled trial.
Setting


This study was conducted in a tertiary care and academic research center.
Patients


One hundred patients were included in the study: 50 in misoprostol group and 50 in placebo.
Interventions


Patients underwent office hysteroscopy 4 h after vaginal application of misoprostol or placebo.
Measurements and Main Results


Ease of doing hysteroscopy was significantly better in the misoprostol group (difficulty score: 2.74 ± 1.20) as compared to placebo (difficulty score: 4.20 ± 1.10),  P  = 0.001. The time taken for negotiating the internal os (cervical passage time) was found to be significantly shorter in the misoprostol group (6.20 ± 5.21 s) as compared to placebo (14.78 ± 11.84 s),  P  = 0.001. The overall Visual Analog Scale (VAS) score was significantly lower in the intervention group (2.64 ± 1.62) as compared to placebo (4.90 ± 1.90),  P  = 0.001. Moreover, the VAS score at the point of passing internal os was significantly lower in the misoprostol group (2.82 ± 1.39) as compared to placebo (4.94 ± 1.96),  P  = 0.001. Misoprostol had a significant positive effect on satisfaction level of patients; 76% ( n  = 38) of women in the misoprostol group expressed their willingness to undergo the procedure again if required versus 18% ( n  = 9) in placebo,  P  = 0.001. Furthermore, 78% ( n  = 39) of women in the misoprostol group would recommend the procedure to their friends and relatives versus 36% ( n  = 18) in placebo,  P  = 0.001.
Conclusion


Preoperative cervical preparation with 200 mcg of misoprostol vaginal application 4 h before office hysteroscopy in premenopausal nulliparous women significantly reduces the difficulty encountered in negotiating the cervical canal. Further, it significantly reduces the pain experienced by the patient at the point of passage through internal os as well as throughout the entire procedure.",2020,"Misoprostol had a significant positive effect on satisfaction level of patients; 76% ( n  = 38) of women in the misoprostol group expressed their willingness to undergo the procedure again if required versus 18% ( n  = 9) in placebo,  P  = 0.001.","['premenopausal nulliparous women with 200-mcg single vaginal dose 4 h before the procedure', 'Patients', 'One hundred patients were included in the study: 50 in misoprostol group and 50 in', 'premenopausal nulliparous women', 'Premenopausal Nulliparous Women']","['Placebo', 'Misoprostol', 'misoprostol vaginal application', 'misoprostol or placebo', 'misoprostol', 'placebo']","['VAS score', 'overall Visual Analog Scale (VAS) score', 'satisfaction level', 'time taken for negotiating the internal os (cervical passage time', 'pain', 'Measurements and Main Results\n\n\nEase of doing hysteroscopy']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0227842', 'cui_str': 'Structure of internal os'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}]",100.0,0.57831,"Misoprostol had a significant positive effect on satisfaction level of patients; 76% ( n  = 38) of women in the misoprostol group expressed their willingness to undergo the procedure again if required versus 18% ( n  = 9) in placebo,  P  = 0.001.","[{'ForeName': 'Vinod G', 'Initials': 'VG', 'LastName': 'Nair', 'Affiliation': 'Department of Obstetrics and Gynaecology, Division of Minimally Invasive Gynaecological Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Kallol Kumar', 'Initials': 'KK', 'LastName': 'Roy', 'Affiliation': 'Department of Obstetrics and Gynaecology, Division of Minimally Invasive Gynaecological Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rakhi', 'Initials': 'R', 'LastName': 'Rai', 'Affiliation': 'Department of Obstetrics and Gynaecology, Division of Minimally Invasive Gynaecological Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Anamika', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Obstetrics and Gynaecology, Division of Minimally Invasive Gynaecological Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Juhi', 'Initials': 'J', 'LastName': 'Bharti', 'Affiliation': 'Department of Obstetrics and Gynaecology, Division of Minimally Invasive Gynaecological Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Rinchen', 'Initials': 'R', 'LastName': 'Zangmo', 'Affiliation': 'Department of Obstetrics and Gynaecology, Division of Minimally Invasive Gynaecological Surgery, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of human reproductive sciences,['10.4103/jhrs.JHRS_149_19']
2023,32792761,A Comparative Study of the Efficacy of Levosulpiride versus Paroxetine in Premature Ejaculation.,"Background


Premature ejaculation (PME) can be defined as a lack in the normal voluntary control over ejaculation. It is the most common sexual dysfunction encountered by the male populace. In general, these patients presents with distress. Hence, a novel treatment to eliminate their problem is required. Although the role of SSRI has already been established, the high discontinuation rate and other types of sexual dysfunctions associated with SSRIs reduce their efficacy in controlling this menace. Levosulpiride is a new drug indicated in treatment of PE.
Aims and Objectives


The objective is to study the efficacy of levosulpiride; paroxetine and their comparison in patients of PE.
Methodology


Index of premature ejaculation (IPE) and intravaginal ejaculation latency time (IELT) were used. A total of 36 patients (18 in each group) were included. The patients were assessed at baseline; at 4 weeks' and at 8 weeks' interval.
Results


On comparison the score of IPE in domains of ejaculation control, sexual satisfaction, and the total score of IPE were statistically significant on all the three visits. However, the distress score of IPE and the IELT score were statistically not significant between the two groups.
Conclusion


No doubt both agents are efficacious in patients of PME but paroxetine is more efficacious than levosulpiride. At the same time, levosulpiride is a lesser studied and used drug hence more research should be done for it.",2020,No doubt both agents are efficacious in patients of PME but paroxetine is more efficacious than levosulpiride.,"['36 patients (18 in each group) were included', 'Premature Ejaculation', 'patients of PE.\nMethodology\n\n\nIndex of premature ejaculation (IPE) and']","['Paroxetine', 'levosulpiride; paroxetine', 'paroxetine', 'Levosulpiride', 'levosulpiride', '\n\n\nPremature ejaculation (PME']","['intravaginal ejaculation latency time (IELT', 'score of IPE in domains of ejaculation control, sexual satisfaction, and the total score of IPE', 'distress score of IPE and the IELT score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C0210380', 'cui_str': 'levosulpiride'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}]","[{'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",36.0,0.0341408,No doubt both agents are efficacious in patients of PME but paroxetine is more efficacious than levosulpiride.,"[{'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Bathla', 'Affiliation': 'Department of Psychiatry, Maharishi Markandeshwar Institute of Medical Sciences and Research, MMDU, Mullana, Haryana, India.'}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Anjum', 'Affiliation': 'Department of Psychiatry, Maharishi Markandeshwar Institute of Medical Sciences and Research, MMDU, Mullana, Haryana, India.'}, {'ForeName': 'Angad Harshbir', 'Initials': 'AH', 'LastName': 'Singh', 'Affiliation': 'Department of Psychiatry, Maharishi Markandeshwar Institute of Medical Sciences and Research, MMDU, Mullana, Haryana, India.'}, {'ForeName': 'Vinutha', 'Initials': 'V', 'LastName': 'Ramesh', 'Affiliation': 'Department of Psychiatry, Maharishi Markandeshwar Institute of Medical Sciences and Research, MMDU, Mullana, Haryana, India.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Department of Psychiatry, Maharishi Markandeshwar Institute of Medical Sciences and Research, MMDU, Mullana, Haryana, India.'}, {'ForeName': 'Leezu', 'Initials': 'L', 'LastName': 'Bhusri', 'Affiliation': 'Department of Psychiatry, Maharishi Markandeshwar Institute of Medical Sciences and Research, MMDU, Mullana, Haryana, India.'}]",Journal of human reproductive sciences,['10.4103/jhrs.JHRS_155_19']
2024,32792900,The Effect of Music Intervention on Attention in Children: Experimental Evidence.,"Although music has been utilized as a therapeutic tool for children with cognitive impairments, how it improves children's cognitive function remains poorly understood. As a first step toward understanding music's effectiveness and as a means of assessing cognitive function improvement, we focused on attention, which plays an important role in cognitive development, and examined the effect of a music intervention on children's attention. Thirty-five children, aged 6 to 9 years, participated in this study, with data from 29 of the children being included in the analysis. A single 30-minute interactive music intervention was compared with a single 30-minute interactive video game intervention accompanied by computer-generated background music using a within-subjects repeated-measures design. Each intervention was implemented individually. Participants completed a standardized attention assessment, the Test of Everyday Attention for Children, before and after both interventions to assess changes in their attentional skills. The results indicated significant improvement in attention control/switching following the music intervention after controlling for the children's intellectual abilities, while no such changes were observed following the video game intervention. This study provides the first evidence that music interventions may be more effective than video game interventions to improve attention control in children, and furthers our understanding of the importance of music interventions for children with attention control problems.",2020,"The results indicated significant improvement in attention control/switching following the music intervention after controlling for the children's intellectual abilities, while no such changes were observed following the video game intervention.","['children with cognitive impairments', 'Thirty-five children, aged 6 to 9 years, participated in this study, with data from 29 of the children being included in the analysis', 'children with attention control problems', 'Children', ""children's attention""]","['Music Intervention', 'music intervention']",['attention control/switching'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",35.0,0.0642069,"The results indicated significant improvement in attention control/switching following the music intervention after controlling for the children's intellectual abilities, while no such changes were observed following the video game intervention.","[{'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Kasuya-Ueba', 'Affiliation': 'Department of Human Health Science, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Institute of Psychology, Shenzhen Key Laboratory of Affective and Social Neuroscience, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Motomi', 'Initials': 'M', 'LastName': 'Toichi', 'Affiliation': 'Department of Human Health Science, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00757']
2025,32792957,Phosphodiesterase 4 Inhibitors in Allergic Rhinitis/Rhinosinusitis.,"Allergic rhinitis/rhinosinusitis (AR) is the most common allergic disease. It affects patients' quality of life and may influence the severity of lower airway disease such as asthma. Therefore, its treatment is of great importance. AR is treated by a combination of effective approaches; however, in some patients, the disease is uncontrolled. In the last several years, the concept of AR has shifted from increased T helper 2 (Th2) cell signaling and downstream inflammation to disease phenotypes with non-Th2-mediated inflammation. AR is a largely heterogenous group of airway diseases, and as such, research should not only focus on immunosuppressive agents (e.g., corticosteroids) but should also include targeted immunomodulatory pathways. Here, we provide an overview of novel therapies, focusing on the role of phosphodiesterase-4 (PDE4) inhibitors in AR. PDE4 inhibitors are potent anti-inflammatory agents that are used for the treatment of inflammatory airway diseases including AR. The PDE4 inhibitor roflumilast was shown to effectively control symptoms of AR in a randomized, placebo-controlled, double-blinded, crossover study in patients with a history of AR. However, only a few PDE4 inhibitors have proceeded to phase II and III clinical trials, due to insufficient clinical efficacy and adverse effects. Research is ongoing to develop more effective compounds with fewer side effects that target specific inflammatory pathways in disease pathogenesis and can provide more consistent benefit to patients with upper airway allergic diseases. Novel specific PDE4 inhibitors seem to fulfill these criteria.",2020,"In the last several years, the concept of AR has shifted from increased T helper 2 (Th2) cell signaling and downstream inflammation to disease phenotypes with non-Th2-mediated inflammation.","['patients with upper airway allergic diseases', 'Allergic Rhinitis/Rhinosinusitis', 'Allergic rhinitis/rhinosinusitis (AR', 'patients with a history of AR']","['Phosphodiesterase 4 Inhibitors', 'phosphodiesterase-4 (PDE4) inhibitors', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C2936609', 'cui_str': 'Phosphodiesterase 4 inhibitor'}, {'cui': 'C0070829', 'cui_str': 'Type 4 Cyclic Nucleotide Phosphodiesterase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0151292,"In the last several years, the concept of AR has shifted from increased T helper 2 (Th2) cell signaling and downstream inflammation to disease phenotypes with non-Th2-mediated inflammation.","[{'ForeName': 'Viera', 'Initials': 'V', 'LastName': 'Janosova', 'Affiliation': 'Clinic of Otorhinolaryngology and Head and Neck Surgery, Jessenius Faculty of Medicine, Comenius University in Bratislava, and Martin University Hospital, Martin, Slovakia.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Calkovsky', 'Affiliation': 'Clinic of Otorhinolaryngology and Head and Neck Surgery, Jessenius Faculty of Medicine, Comenius University in Bratislava, and Martin University Hospital, Martin, Slovakia.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Pedan', 'Affiliation': 'Clinic of Otorhinolaryngology and Head and Neck Surgery, Jessenius Faculty of Medicine, Comenius University in Bratislava, and Martin University Hospital, Martin, Slovakia.'}, {'ForeName': 'Estera', 'Initials': 'E', 'LastName': 'Behanova', 'Affiliation': 'Clinic of Otorhinolaryngology and Head and Neck Surgery, Jessenius Faculty of Medicine, Comenius University in Bratislava, and Martin University Hospital, Martin, Slovakia.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Hajtman', 'Affiliation': 'Clinic of Otorhinolaryngology and Head and Neck Surgery, Jessenius Faculty of Medicine, Comenius University in Bratislava, and Martin University Hospital, Martin, Slovakia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Calkovska', 'Affiliation': 'Department of Physiology, Jessenius Faculty of Medicine, Comenius University in Bratislava, Martin, Slovakia.'}]",Frontiers in pharmacology,['10.3389/fphar.2020.01135']
2026,32793007,A Group-Based Community Reinforcement Approach of Cognitive Behavioral Therapy Program to Improve Self-Care Behavior of Patients With Type 2 Diabetes.,"Introduction


This study evaluated a cognitive behavioral-based self-care intervention program on diabetes management in individuals with type 2 diabetes in Jiangsu Province, China. People with type 2 diabetes were recruited to a 6-month, prospective, intervention study.
Methods


The intervention group (n = 296) received an intensive cognitive behavioral-based self-care intervention, including group activities, frequent blood glucose monitoring, nutritional counseling, diabetes-specific meal and a weekly progress report. The control group (n = 110) received diabetes education, including diet and physical activity instruction only. Assessment data was obtained at baseline, and after 12 and/or 24 weeks of intervention. The intention to treat method was used to assess the effectiveness of the intervention program.
Results


The intervention group showed improved fasting blood glucose, HbA1c, systolic and diastolic blood pressures compared to the control group. The intervention group also had significantly improved knowledge and self-care behavior, and general health.
Conclusion


This study demonstrates that significant improvement in glycemic control and markers of cardiovascular health can occur in Chinese people with type 2 diabetes following a CBT-based intervention program that includes diabetes education, frequent blood glucose monitoring and daily use of a diabetes-specific meal plan, suggesting CBT is beneficial to improve health outcome in patients with type 2 diabetes.",2020,"The intervention group showed improved fasting blood glucose, HbA1c, systolic and diastolic blood pressures compared to the control group.","['People with type 2 diabetes', 'Chinese people with type 2 diabetes', 'Patients', 'patients with type 2 diabetes', 'individuals with type 2 diabetes in Jiangsu Province, China']","['Cognitive Behavioral Therapy Program', 'cognitive behavioral-based self-care intervention program', 'diabetes education, including diet and physical activity instruction only', 'intensive cognitive behavioral-based self-care intervention, including group activities, frequent blood glucose monitoring, nutritional counseling, diabetes-specific meal and a weekly progress report']","['knowledge and self-care behavior, and general health', 'Self-Care Behavior', 'glycemic control and markers of cardiovascular health', 'fasting blood glucose, HbA1c, systolic and diastolic blood pressures']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0242586', 'cui_str': 'Progress report'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.012964,"The intervention group showed improved fasting blood glucose, HbA1c, systolic and diastolic blood pressures compared to the control group.","[{'ForeName': 'Xiaoqun', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Jiangsu Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Zhen Jiang Center for Disease Control and Prevention, Zhenjiang, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'Nanjing Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Chunzao', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Yan Cheng Center for Disease Control and Prevention, Yancheng, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Jiangsu Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Buys', 'Affiliation': 'School of Medicine, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Yongqing', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Jiangsu Center for Disease Control and Prevention, Nanjing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'School of Medicine, Griffith University, Gold Coast, QLD, Australia.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00719']
2027,32793044,"Novel Mat Exergaming to Improve the Physical Performance, Cognitive Function, and Dual-Task Walking and Decrease the Fall Risk of Community-Dwelling Older Adults.","Physical exercise and cognitive training were previously demonstrated to improve the physical functioning and decrease the incidence of falls for older adults. This study aimed to utilize an interactive exergame mat system to develop a novel cognitive-physical training program and explore the training effects on physical performance, cognitive function, dual-task walking (DTW), and fall risk compared to the control condition. In this quasi-experimental non-randomized controlled intervention study, 110 community-dwelling older adults participated. The exercise group ( n  = 56; mean age, 70.7 ± 4.6 years) performed ladder-type, three-by-three grid-type, and circle-type mat exergames with simultaneous cognitive-physical training (EMAT), while the control group ( n  = 54; mean age, 72.0 ± 5.7 years) underwent a multicomponent exercise intervention focused on physical and cognitive training. A 2 h training session was completed weekly for 3 months. Functional fitness (including upper- and lower-extremity strength and flexibility, grasp strength, aerobic endurance, static balance, dynamic balance and agility), a foot tapping test (FTT), the Montreal Cognitive Assessment (MoCA), DTW, and a fall risk questionnaire (FRQ) were assessed before and after the interventions. The EMAT program enhanced upper-extremity strength, lower-extremity strength and flexibility, aerobic endurance, and dynamic balance and agility; improved DTW and FTT performances; and decreased FRQ score. EMAT also showed a significant advantage over control in terms of lower-extremity strength and flexibility, aerobic endurance, dynamic balance and agility, and FRQ score (all  P  < 0.05). The current study provides evidence of the effects of a novel mat exergaming program on physical and cognitive performance. EMAT effectively reduced the fall risk and increased the dual-task ability of walking, factors that are important in fall prevention for community-dwelling older adults.",2020,"EMAT also showed a significant advantage over control in terms of lower-extremity strength and flexibility, aerobic endurance, dynamic balance and agility, and FRQ score (all  P  < 0.05).","['older adults', ' n  = 54; mean age, 72.0 ± 5.7 years) underwent a', 'community-dwelling older adults', 'Community-Dwelling Older Adults', '110 community-dwelling older adults participated']","['ladder-type, three-by-three grid-type, and circle-type mat exergames with simultaneous cognitive-physical training (EMAT), while the control group', 'Physical exercise and cognitive training', 'multicomponent exercise intervention focused on physical and cognitive training', 'novel mat exergaming program']","['physical and cognitive performance', 'Physical Performance, Cognitive Function, and Dual-Task Walking', 'upper-extremity strength, lower-extremity strength and flexibility, aerobic endurance, and dynamic balance and agility; improved DTW and FTT performances; and decreased FRQ score', 'physical performance, cognitive function, dual-task walking (DTW), and fall risk', 'fall risk and increased the dual-task ability of walking, factors', 'physical functioning', 'Functional fitness (including upper- and lower-extremity strength and flexibility, grasp strength, aerobic endurance, static balance, dynamic balance and agility), a foot tapping test (FTT), the Montreal Cognitive Assessment (MoCA), DTW, and a fall risk questionnaire (FRQ', 'lower-extremity strength and flexibility, aerobic endurance, dynamic balance and agility, and FRQ score']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4517536', 'cui_str': '110'}]","[{'cui': 'C0336762', 'cui_str': 'Ladder'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0231706', 'cui_str': 'Circling gait'}, {'cui': 'C0066317', 'cui_str': 'methylallyl trisulfide'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",110.0,0.00959424,"EMAT also showed a significant advantage over control in terms of lower-extremity strength and flexibility, aerobic endurance, dynamic balance and agility, and FRQ score (all  P  < 0.05).","[{'ForeName': 'Hsien-Te', 'Initials': 'HT', 'LastName': 'Peng', 'Affiliation': 'Department of Physical Education, Chinese Culture University, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Wen', 'Initials': 'CW', 'LastName': 'Tien', 'Affiliation': 'Department of Physical Education, Chinese Culture University, Taipei, Taiwan.'}, {'ForeName': 'Pay-Shin', 'Initials': 'PS', 'LastName': 'Lin', 'Affiliation': 'Department of Physical Therapy and Graduate Institute of Rehabilitation Science, College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Hsuen-Ying', 'Initials': 'HY', 'LastName': 'Peng', 'Affiliation': 'Department of Exercise and Health Science, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}, {'ForeName': 'Chen-Yi', 'Initials': 'CY', 'LastName': 'Song', 'Affiliation': 'Department of Long-Term Care, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01620']
2028,32793403,Two-year long safety and efficacy of deferasirox film-coated tablets in patients with thalassemia or lower/intermediate risk MDS: phase 3 results from a subset of patients previously treated with deferasirox in the ECLIPSE study.,"Background


Despite the proven benefits of iron chelation therapy (ICT) in the management of chronic iron overload and related complications, compliance to long-term ICT is challenging. Results from the ECLIPSE study, an open-label, randomized, multicenter, 2-arm, phase 2 study evaluated the safety of deferasirox dispersible tablet and film-coated tablet (FCT) formulations in patients with transfusion-dependent thalassemia (TDT) or very low, low, or intermediate risk myelodysplastic syndrome (MDS) treated over 24 weeks.
Methods


The aim of the current study (a 2-year, open-label, multicenter, single-arm, phase 3 study) is to evaluate the long-term safety and efficacy of deferasirox FCT in a subset of patients with TDT or lower/intermediate-risk MDS treated for 2 years after the completion of 24 weeks of treatment with deferasirox in the ECLIPSE phase 2 study.
Results


Of 53 patients enrolled, 34 (64.2%) completed treatment and study. Adverse events (AEs) reported in most patients (~ 70%) were of mild to moderate severity. Headache and diarrhea were the most frequently (> 25%) reported AEs. None of the serious AEs (including 1 death) were considered treatment related. No new safety signal was identified, and long-term safety of deferasirox FCT was consistent with the known safety profile of deferasirox. No major concerns associated with gastrointestinal tolerability, renal safety, or hematological abnormalities (thrombocytopenia/neutropenia) were reported during the 2 years. Patients receiving deferasirox FCT had a treatment compliance (by pill count) of ~ 90% and persistence (continuous use for ≥ 30 days) of > 95%. Reduction in serum ferritin level was almost consistent starting from week 2 across all post-baseline time points (relative reduction: month 6, 19%; month 12, 29%).
Conclusions


The results from this 2-year interventional study suggest that the recommended dosing of deferasirox FCT, with better tolerability, palatability, and compliance, offers a favorable option of ICT for long-term management of iron overload and associated complications in TDT. Trial registration  ClinicalTrials.gov, NCT02720536. Registered 28 March 2016, https://www.clinicaltrials.gov/ct2/show/NCT02720536.",2020,"No major concerns associated with gastrointestinal tolerability, renal safety, or hematological abnormalities (thrombocytopenia/neutropenia) were reported during the 2 years.","['53 patients enrolled, 34 (64.2%) completed treatment and study', 'patients with thalassemia or lower/intermediate risk MDS', 'patients previously treated with deferasirox in the ECLIPSE study', 'patients with transfusion-dependent thalassemia (TDT) or very low, low, or intermediate risk myelodysplastic syndrome (MDS) treated over 24\xa0weeks', 'patients with TDT or lower/intermediate-risk MDS treated for 2\xa0years after the completion of 24\xa0weeks of treatment with deferasirox in the ECLIPSE phase 2 study']","['deferasirox dispersible tablet and film-coated tablet (FCT) formulations', 'iron chelation therapy (ICT', 'deferasirox film-coated tablets', 'deferasirox FCT']","['gastrointestinal tolerability, renal safety, or hematological abnormalities (thrombocytopenia/neutropenia', 'tolerability, palatability, and compliance', 'Adverse events (AEs', 'serum ferritin level', 'Headache and diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1619629', 'cui_str': 'deferasirox'}, {'cui': 'C4760934', 'cui_str': 'Transfusion dependent thalassaemia'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}]","[{'cui': 'C1619629', 'cui_str': 'deferasirox'}, {'cui': 'C0991504', 'cui_str': 'Disintegrating Oral Tablet'}, {'cui': 'C1273643', 'cui_str': 'Film-coated tablet'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0007975', 'cui_str': 'Chelation therapy'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",53.0,0.0729343,"No major concerns associated with gastrointestinal tolerability, renal safety, or hematological abnormalities (thrombocytopenia/neutropenia) were reported during the 2 years.","[{'ForeName': 'Immacolata', 'Initials': 'I', 'LastName': 'Tartaglione', 'Affiliation': 'Department of Woman, Child and of General and Specialist Surgery, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Origa', 'Affiliation': 'Ospedale Pediatrico Microcitemico ""A.Cao,"" A.O. ""G.Brotzu"", Cagliari, Italy.'}, {'ForeName': 'Antonis', 'Initials': 'A', 'LastName': 'Kattamis', 'Affiliation': 'Division of Pediatric Hematology-Oncology, First Department of Pediatrics, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pfeilstöcker', 'Affiliation': 'Third Medical Department, Hanusch Hospital, Vienna, Austria.'}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Gunes', 'Affiliation': 'Novartis Farma SPA, Origgio, Lombardy Italy.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Crowe', 'Affiliation': 'Novartis Ireland Limited, Dublin, Ireland.'}, {'ForeName': 'Niamh', 'Initials': 'N', 'LastName': 'Fagan', 'Affiliation': 'Novartis Ireland Limited, Dublin, Ireland.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Vincenzi', 'Affiliation': 'Novartis Farma SPA, Origgio, Lombardy Italy.'}, {'ForeName': 'Giovan Battista', 'Initials': 'GB', 'LastName': 'Ruffo', 'Affiliation': 'U.O.C. Ematologia e Talassemia, A.O. Civico-Di Cristina-Benfratelli, Piazza Nicola Leotta 4, 90127 Palermo, Italy.'}]",Experimental hematology & oncology,['10.1186/s40164-020-00174-2']
2029,32793485,Increased Dose to Organs in Urinary Tract Associates With Measures of Genitourinary Toxicity in Pooled Voxel-Based Analysis of 3 Randomized Phase III Trials.,"Purpose:  Dose information from organ sub-regions has been shown to be more predictive of genitourinary toxicity than whole organ dose volume histogram information. This study aimed to identify anatomically-localized regions where 3D dose is associated with genitourinary toxicities in healthy tissues throughout the pelvic anatomy.  Methods and Materials:  Dose distributions for up to 656 patients of the Trans-Tasman Radiation Oncology Group 03.04 RADAR trial were deformably registered onto a single exemplar CT dataset. Voxel- based multiple comparison permutation dose difference testing, Cox regression modeling and LASSO feature selection were used to identify regions where 3D dose-increase was associated with late grade ≥ 2 genitourinary dysuria, incontinence and frequency, and late grade ≥ 1 haematuria. This was externally validated by registering dose distributions from the RT01 (up to  n  = 388) and CHHiP (up to  n  = 247) trials onto the same exemplar and repeating the voxel-based tests on each of these data sets. All three datasets were then combined, and the tests repeated.  Results:  Voxel-based Cox regression and multiple comparison permutation dose difference testing revealed regions where increased dose was correlated with genitourinary toxicity. Increased dose in the vicinity of the membranous and spongy urethra was associated with dysuria for all datasets. Haematuria was similarly correlated with increased dose at the membranous and spongy urethra, for the RADAR, CHHiP, and combined datasets. Some evidence was found for the association between incontinence and increased dose at the internal and external urethral sphincter for RADAR and the internal sphincter alone for the combined dataset. Incontinence was also strongly correlated with dose from posterior oblique beams. Patients with fields extending inferiorly and posteriorly to the CTV, adjacent to the membranous and spongy urethra, were found to experience increased frequency.  Conclusions:  Anatomically-localized dose-toxicity relationships were determined for late genitourinary symptoms in the urethra and urinary sphincters. Low-intermediate doses to the extraprostatic urethra were associated with risk of late dysuria and haematuria, while dose to the urinary sphincters was associated with incontinence.",2020,"Low-intermediate doses to the extraprostatic urethra were associated with risk of late dysuria and haematuria, while dose to the urinary sphincters was associated with incontinence.",[],['CHHiP'],"['Haematuria', 'genitourinary toxicity', 'Incontinence']",[],[],"[{'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0042066', 'cui_str': 'Structure of genitourinary system'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}]",,0.0218456,"Low-intermediate doses to the extraprostatic urethra were associated with risk of late dysuria and haematuria, while dose to the urinary sphincters was associated with incontinence.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Marcello', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Denham', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Kennedy', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Haworth', 'Affiliation': 'School of Physics, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Steigler', 'Affiliation': 'Prostate Cancer Trials Group, School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Greer', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Lois C', 'Initials': 'LC', 'LastName': 'Holloway', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Liverpool, NSW, Australia.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Dowling', 'Affiliation': 'School of Mathematical and Physical Sciences, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Jameson', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Liverpool, NSW, Australia.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Roach', 'Affiliation': 'Department of Medical Physics, Liverpool Cancer Centre, Liverpool, NSW, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': 'School of Surgery, University of Western Australia, Perth, WA, Australia.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Gulliford', 'Affiliation': 'Radiotherapy Department, University College London Hospitals NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'Academic UroOncology Unit, The Institute of Cancer Research and the Royal Marsden NHS Trust, London, United Kingdom.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit, Medical Research Council, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Martin A', 'Initials': 'MA', 'LastName': 'Ebert', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.'}]",Frontiers in oncology,['10.3389/fonc.2020.01174']
2030,32793536,Effects of Whole Body Electromyostimulation on Physical Fitness and Health in Postmenopausal Women: A Study Protocol for a Randomized Controlled Trial.,"Background:  Age-related problems such as chronic diseases, functional limitation and dependence, reduce the quality of life in the elderly, and increase public spending in health. It has been established that physical activity plays a fundamental role in the health of the elderly. The whole body electromyostimulation (WB-EMS) could be a successful methodology as high-intensity training to improve the physical fitness of older people.  Methods:  A minimum of 13 women between 55 and 70 years old will be randomized in two groups. The exercise with WB-EMS group (EX + WB-EMS) will conduct a resistance strength training program with superimposed WB-EMS while the exercise group (EX) will perform only resistance strength and aerobic training. Balance, strength, flexibility, agility, speed, and aerobic performance (EXERNET battery and progressive resistance test), as well as body composition, blood parameters and physical activity reporting (IPAQ-E) will be assessed to analyze the effects of whole body electromyostimulation in the physical fitness and the health in postmenopausal women.  Discussion:  Innovative and scientifically well-designed protocols are needed to enhance the knowledge of the body's responses within this training methodology which is being used by a big quantity of population. This trial will provide evidence on the effectiveness of whole-body electromyostimulation in physical fitness and health in elderly women.  Trial Registration:  ISRCTN15558857 registration data: 27/11/2019 (retrospectively registered).",2020,"Balance, strength, flexibility, agility, speed, and aerobic performance (EXERNET battery and progressive resistance test), as well as body composition, blood parameters and physical activity reporting (IPAQ-E) will be assessed to analyze the effects of whole body electromyostimulation in the physical fitness and the health in postmenopausal women.  ","['Postmenopausal Women', 'postmenopausal women', '13 women between 55 and 70 years old', 'elderly women']","['whole-body electromyostimulation', 'Whole Body Electromyostimulation', 'exercise with WB-EMS group (EX + WB-EMS']","['Balance, strength, flexibility, agility, speed, and aerobic performance (EXERNET battery and progressive resistance test), as well as body composition, blood parameters and physical activity reporting (IPAQ-E', 'Physical Fitness and Health']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0305683,"Balance, strength, flexibility, agility, speed, and aerobic performance (EXERNET battery and progressive resistance test), as well as body composition, blood parameters and physical activity reporting (IPAQ-E) will be assessed to analyze the effects of whole body electromyostimulation in the physical fitness and the health in postmenopausal women.  ","[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Pano-Rodriguez', 'Affiliation': 'Research Group Human Movement, University of Lleida, Lleida, Spain.'}, {'ForeName': 'Jose Vicente', 'Initials': 'JV', 'LastName': 'Beltran-Garrido', 'Affiliation': 'EUSES Health and Sport Sciences School, Rovira i Virgili University, Tarragona, Spain.'}, {'ForeName': 'Vicenç', 'Initials': 'V', 'LastName': 'Hernandez-Gonzalez', 'Affiliation': 'Research Group Human Movement, University of Lleida, Lleida, Spain.'}, {'ForeName': 'Joaquim', 'Initials': 'J', 'LastName': 'Reverter-Masia', 'Affiliation': 'Research Group Human Movement, University of Lleida, Lleida, Spain.'}]",Frontiers in public health,['10.3389/fpubh.2020.00313']
2031,32793670,Effects of intravenous and inhalation anesthesia on blood glucose and complications in patients with type 2 diabetes mellitus: study protocol for a randomized controlled trial.,"Background


Diabetes mellitus (DM) is a metabolic disorder syndrome caused by relative or absolute lack of insulin and varying degrees of insulin resistance. The type and regimen of anesthesia may affect perioperative hyperglycemia following major surgical stress. The effect of perioperative anesthetics on the blood glucose level of diabetic patients will play an essential role in the postoperative recovery of patients. However, there is no rigorously-designed randomized controlled trial to compare the effects of total intravenous anesthesia (TIVA) and total inhalation anesthesia (TIHA) on blood glucose and complications in type 2 diabetes. Hence, we design this clinical trial to compare the effects of TIVA and TIHA of hyperglycemia and clinical outcomes in type 2 diabetes undergoing surgery.
Methods


This is a randomized, double-blind, parallel controlled trial. One hundred twelve patients with type 2 DM who meet the qualification criteria will be randomly divided into two groups: TIVA group and TIHA group. The levels of serum insulin and cortisol will be measured before and after the operation, and the levels of blood glucose at different setting time will be monitored. All patients will be followed up by blinded evaluators at baseline and 1, 3, 7, and 30 days after the intervention. The follow-up included postoperative complications [such as myocardial infarction (MI), stroke, renal failure, anastomotic fistula, stress ulcer, incision infection, lung infection] and adverse events.
Discussion


The routinely used clinical anesthesia schemes are TIVA, TIHA and intravenous-inhalation combined anesthesia. We expect that the results of this trial will provide high-quality clinical evidence for the choice of anesthesia options for patients with type 2 DM.
Trial registration


Chinese Clinical Trial Registry: ChiCTR2000029247, registration date: 20 January 2020.",2020,One hundred twelve patients with type 2 DM who meet the qualification criteria will be randomly divided into two groups: TIVA group and TIHA group.,"['patients with type 2 DM', 'type 2 diabetes undergoing surgery', 'patients with type 2 diabetes mellitus', '20 January 2020', 'major surgical stress', 'diabetic patients', 'type 2 diabetes', 'One hundred twelve patients with type 2 DM who meet the qualification criteria']","['intravenous and inhalation anesthesia', 'total intravenous anesthesia (TIVA) and total inhalation anesthesia (TIHA', 'TIVA group and TIHA', 'TIVA and TIHA', 'perioperative anesthetics']","['blood glucose and complications', 'blood glucose level', 'perioperative hyperglycemia', 'levels of serum insulin and cortisol', 'levels of blood glucose', 'postoperative complications [such as myocardial infarction (MI), stroke, renal failure, anastomotic fistula, stress ulcer, incision infection, lung infection] and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002917', 'cui_str': 'Anesthesia, Inhalation'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C2609055', 'cui_str': 'Anastomotic fistula'}, {'cui': 'C0400807', 'cui_str': 'Stress ulcer of stomach'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",112.0,0.21583,One hundred twelve patients with type 2 DM who meet the qualification criteria will be randomly divided into two groups: TIVA group and TIHA group.,"[{'ForeName': 'Xing-Hui', 'Initials': 'XH', 'LastName': 'Xiong', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Qian-Yao', 'Initials': 'QY', 'LastName': 'Deng', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Xing-Wei', 'Initials': 'XW', 'LastName': 'Cai', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liang', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, China.'}]",Annals of translational medicine,['10.21037/atm-20-2045a']
2032,32793705,Minimum local anesthetic dose of ropivacaine in real-time ultrasound-guided intraspinal anesthesia for lower extremity surgery: a randomized controlled trial.,"Background


Despite the many advantages real-time ultrasound-guided lumbar anesthesia has over traditional lumbar anesthesia, it seemingly involves a much higher dose of ropivacaine. This study aimed to determine the minimum local anesthetic dose (MLAD) and the 95% confidence interval of ropivacaine at different concentrations in real-time ultrasound-guided lumbar anesthesia for lower extremity surgery.
Methods


A total of 60 patients who were consecutively scheduled for selective lower extremity surgery were enrolled. The patients were randomly divided into two groups, which each received different concentrations of ropivacaine at different initial dosages when Dixon's up-and-down sequential method was applied. The high ropivacaine group and the low ropivacaine group received 0.75% and 0.5% ropivacaine, respectively. The patients' baseline characteristics, the MLAD, and the 95% confidence interval were assessed. The highest level of sensory block, time to reach the T10 sensory block, duration for sensory blocks higher than T10, highest plane for sensory block, and onset time and duration for motor block were recorded. Comparisons were also made between the patients' vital signs and adverse reactions.
Results


The minimum local anaesthetic dose (MLAD) and 95% confidence interval in the high ropivacaine group and the low ropivacaine group were 17.176 (16.276 to 18.124) and 20.192 (19.256 to 21.174) mg, respectively. Moreover, motor block maintenance was greatly reduced in the 0.5% ropivacaine compared to the 0.75% ropivacaine group (P=0.0309).
Conclusions


In real-time ultrasound-guided intraspinal anesthesia for lower extremity surgery, both 0.75% and 0.5% ropivacaine provide satisfactory anesthesia. Our results suggest that shortened motor block duration can hold benefits for patients including earlier mobilization and a quicker rehabilitation process.",2020,"Moreover, motor block maintenance was greatly reduced in the 0.5% ropivacaine compared to the 0.75% ropivacaine group (P=0.0309).
","['lower extremity surgery', '60 patients who were consecutively scheduled for selective lower extremity surgery were enrolled']",['ropivacaine'],"['minimum local anaesthetic dose (MLAD', 'vital signs and adverse reactions', 'highest level of sensory block, time to reach the T10 sensory block, duration for sensory blocks higher than T10, highest plane for sensory block, and onset time and duration for motor block', 'motor block maintenance']","[{'cui': 'C0187763', 'cui_str': 'Surgical procedure on lower extremity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",60.0,0.075719,"Moreover, motor block maintenance was greatly reduced in the 0.5% ropivacaine compared to the 0.75% ropivacaine group (P=0.0309).
","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': 'Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Ye', 'Affiliation': 'Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Weilan', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of Anaesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Lifei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Xiaochun', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, China.'}, {'ForeName': 'Mingxue', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Anaesthesiology, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, China.'}]",Annals of translational medicine,['10.21037/atm-20-3805']
2033,32795098,"Cangrelor, Tirofiban, and Chewed or Standard Prasugrel Regimens in Patients With ST-Segment-Elevation Myocardial Infarction: Primary Results of the FABOLUS-FASTER Trial.","BACKGROUND


Standard administration of newer oral P2Y 12  inhibitors, including prasugrel or ticagrelor, provides suboptimal early inhibition of platelet aggregation (IPA) in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention. We aimed to investigate the effects of cangrelor, tirofiban, and prasugrel, administered as chewed or integral loading dose, on IPA in patients undergoing primary percutaneous coronary intervention.
METHODS


The FABOLUS-FASTER trial (Facilitation Through Aggrastat or Cangrelor Bolus and Infusion Over Prasugrel: A Multicenter Randomized Open-Label Trial in Patients with ST-Elevation Myocardial Infarction Referred for Primary Percutaneous Intervention) is an investigator-initiated, multicenter, open-label, randomized study. A total of 122 P2Y 12 -naive patients with ST-segment-elevation myocardial infarction were randomly allocated (1:1:1) to cangrelor (n=40), tirofiban (n=40) (both administered as bolus and 2-hour infusion followed by 60 mg of prasugrel), or 60-mg loading dose of prasugrel (n=42). The latter group underwent an immediate 1:1 subrandomization to chewed (n=21) or integral (n=21) tablets administration. The trial was powered to test 3 hypotheses (noninferiority of cangrelor compared with tirofiban using a noninferiority margin of 9%, superiority of both tirofiban and cangrelor compared with chewed prasugrel, and superiority of chewed prasugrel as compared with integral prasugrel, each with α=0.016 for the primary end point, which was 30-minute IPA at light transmittance aggregometry in response to 20 μmol/L adenosine diphosphate.
RESULTS


At 30 minutes, cangrelor did not satisfy noninferiority compared with tirofiban, which yielded superior IPA over cangrelor (95.0±8.9 versus 34.1±22.5;  P <0.001). Cangrelor or tirofiban were both superior to chewed prasugrel (IPA, 10.5±11.0;  P <0.001 for both comparisons), which did not provide higher IPA over integral prasugrel (6.3±11.4;  P =0.47), despite yielding higher prasugrel active metabolite concentration (ng/mL; 62.3±82.6 versus 17.1±43.5;  P =0.016).
CONCLUSIONS


Cangrelor provided inferior IPA compared with tirofiban; both treatments yielded greater IPA compared with chewed prasugrel, which led to higher active metabolite concentration but not greater IPA compared with integral prasugrel. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02978040; URL: https://www.clinicaltrialsregister.eu; EudraCT 2017-001065-24.",2020,"CONCLUSIONS


Cangrelor provided inferior IPA compared with tirofiban; both treatments yielded greater IPA compared with chewed prasugrel, which led to higher active metabolite concentration but not greater IPA compared with integral prasugrel.","['122 P2Y 12 -naive patients with ST-segment-elevation myocardial infarction', 'Patients With ST-Segment-Elevation Myocardial Infarction', 'Patients with ST-Elevation Myocardial Infarction Referred for Primary Percutaneous Intervention', 'patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention', 'patients undergoing primary percutaneous coronary intervention']","['tirofiban (n=40) (both administered as bolus and 2-hour infusion followed by 60 mg of prasugrel), or 60-mg loading dose of prasugrel', 'tirofiban', 'Cangrelor or tirofiban', 'prasugrel or ticagrelor', 'cangrelor, tirofiban, and prasugrel', 'Prasugrel', 'Cangrelor, Tirofiban, and Chewed or Standard Prasugrel Regimens', 'cangrelor', 'tirofiban and cangrelor']","['active metabolite concentration', 'prasugrel active metabolite concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0247025', 'cui_str': 'tirofiban'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1292425', 'cui_str': '2 hours'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1121991', 'cui_str': 'cangrelor'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}]",,0.176081,"CONCLUSIONS


Cangrelor provided inferior IPA compared with tirofiban; both treatments yielded greater IPA compared with chewed prasugrel, which led to higher active metabolite concentration but not greater IPA compared with integral prasugrel.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Gargiulo', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Esposito', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.).'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Avvedimento', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nagler', 'Affiliation': 'University Institute of Clinical Chemistry, Inselspital (M.N.), University of Bern, Switzerland.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Minuz', 'Affiliation': 'Department of Medicine, Unit of General Medicine for the Study and Treatment of Hypertensive Disease, University of Verona, Policlinico GB Rossi, Italy (P.M.).'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': 'Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Italy (G.C., M.T.).'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Gragnano', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}, {'ForeName': 'Negar', 'Initials': 'N', 'LastName': 'Manavifar', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Piccolo', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.).'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Tebaldi', 'Affiliation': 'Cardiology Unit, Azienda Ospedaliera Universitaria di Ferrara, Italy (G.C., M.T.).'}, {'ForeName': 'Plinio', 'Initials': 'P', 'LastName': 'Cirillo', 'Affiliation': 'Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (G.G., G.E., M.A., R.P., P.C.).'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Hunziker', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Intensive Care Medicine, Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Belgium (P.V.).'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Leonardi', 'Affiliation': 'University of Pavia and Fondazione IRCCS Policlinico S Matteo, Italy (S.L.).'}, {'ForeName': 'Dik', 'Initials': 'D', 'LastName': 'Heg', 'Affiliation': 'Bern University Hospital, and Clinical Trials Unit, CTU Bern (D.H.), University of Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology (G.G., F.G., N.M., L.H., S.W., M.V.), University of Bern, Switzerland.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.046928']
2034,32795144,Content Analysis: First-Time Patient User Challenges with Top-Rated Commercial Diabetes Apps.,"Background/Introduction:  Using a mobile application (app) may improve diabetes self-management. However, the use of diabetes apps is low, possibly due to design and usability issues. The purpose of this study was to identify barriers to app use among adult patients with diabetes who were testing diabetes apps for the first time.  Materials and Methods:  We conducted a content analysis of observation notes and patient comments collected during the testing of two top commercially available diabetes apps as part of a crossover randomized trial. Participants were adult patients with type 1 or type 2 diabetes on insulin therapy. We analyzed field notes and transcriptions of audio recordings. Open coding derived categories of usability issues, which then were grouped into themes and subthemes on usability problem types.  Results:  A total of 92 adult Android smartphone users were recruited online (e.g., Facebook) and in-person postings. Three major themes described problems with data input, app report display and presentation, and self-learning options. Data entry modes were problematic because of overcrowded app screens, complicated ""save data"" steps, and a lack of data entry confirmation. The app icons, wording, entry headings, and analysis reports were not intuitive to understand. Participants wanted self-learning options (e.g., pop-up messages) during app use.  Conclusions:  Patient testing of top commercially available diabetes apps revealed key usability design issues in data entry, app report, and self-help learning options. Good app training for patients is necessary for both initial use and long-term use of diabetes apps to support self-management.",2020,Good app training for patients is necessary for both initial use and long-term use of diabetes apps to support self-management.,"['92 adult Android smartphone users were recruited online (e.g., Facebook) and in-person postings', 'adult patients with diabetes who were testing diabetes apps for the first time', 'Participants were adult patients with type 1 or type 2 diabetes on insulin therapy']",[],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0336541', 'cui_str': 'Android'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],[],92.0,0.036659,Good app training for patients is necessary for both initial use and long-term use of diabetes apps to support self-management.,"[{'ForeName': 'Helen N C', 'Initials': 'HNC', 'LastName': 'Fu', 'Affiliation': 'Center for Aging Science and Care Innovation, School of Nursing, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Jin', 'Affiliation': 'Institute for Health Informatics, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Terrence J', 'Initials': 'TJ', 'LastName': 'Adam', 'Affiliation': 'Institute for Health Informatics, University of Minnesota, Minneapolis, Minnesota, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2020.0128']
2035,32795167,Vitamin D3 supplementation improves glycemic control in type 2 diabetic patients: Results from an Italian clinical trial.,"Background : to evaluate the effects of Vitamin D3 on glyco-metabolic control in type 2 diabetic patients with Vitamin D deficiency.  Methods : one hundred and seventeen patients were randomized to placebo and 122 patients to Vitamin D3. We evaluated anthropometric parameters, glyco-metabolic control, and parathormone (PTH) value at baseline, after 3, and 6 months.  Results : a significant reduction of fasting, and post-prandial glucose was recorded in Vitamin D3 group after 6 months. A significant HbA 1c  decrease was observed in Vitamin D3 (from 7.6% or 60 mmol/mol to 7.1% or 54 mmol) at 6 months compared to baseline, and to placebo (p < 0.05 for both). At the end of the study period, we noticed a change in the amount in doses of oral or subcutaneous hypoglycemic agents and insulin, respectively. The use of metformin, acarbose, and pioglitazone was significantly lower (p = 0.037, p = 0.048, and p = 0.042, respectively) than at the beginning of the study in the Vitamin D3 therapy group. The units of Lispro, Aspart, and Glargine insulin were lower in the Vitamin D3 group at the end of the study (p = 0.031, p = 0.037, and p = 0.035, respectively) than in the placebo group.  Conclusions : in type 2 diabetic patients with Vitamin D deficiency, the restoration of value in the Vitamin D standard has led not only to an improvement in the glyco-metabolic compensation, but also to a reduced posology of some oral hypoglycemic agents and some types of insulin used.",2020,"The use of metformin, acarbose, and pioglitazone was significantly lower (p = 0.037, p = 0.048, and p = 0.042, respectively) than at the beginning of the study in the Vitamin D3 therapy group.","['Methods : one hundred and seventeen patients', 'type 2 diabetic patients with Vitamin D deficiency', 'type 2 diabetic patients']","['metformin, acarbose, and pioglitazone', 'Vitamin D3 therapy', 'Vitamin D3 supplementation', 'Vitamin D3', 'placebo']","['units of Lispro, Aspart, and Glargine insulin', 'Vitamin D3', 'glycemic control', 'anthropometric parameters, glyco-metabolic control, and parathormone (PTH) value', 'reduction of fasting, and post-prandial glucose']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",117.0,0.0501147,"The use of metformin, acarbose, and pioglitazone was significantly lower (p = 0.037, p = 0.048, and p = 0.042, respectively) than at the beginning of the study in the Vitamin D3 therapy group.","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Derosa', 'Affiliation': 'Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': ""D'Angelo"", 'Affiliation': 'Laboratory of Molecular Medicine, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Martinotti', 'Affiliation': 'S.A.V.E. Studi Analisi Valutazioni Economiche Research Centre, Milan, Italy.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Valentino', 'Affiliation': 'S.A.V.E. Studi Analisi Valutazioni Economiche Research Centre, Milan, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Di Matteo', 'Affiliation': 'S.A.V.E. Studi Analisi Valutazioni Economiche Research Centre, Milan, Italy.'}, {'ForeName': 'Giacomo M', 'Initials': 'GM', 'LastName': 'Bruno', 'Affiliation': 'Department of Management information and production Engineering, University of Bergamo, Bergamo, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Maffioli', 'Affiliation': 'Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.'}]",International journal for vitamin and nutrition research. Internationale Zeitschrift fur Vitamin- und Ernahrungsforschung. Journal international de vitaminologie et de nutrition,['10.1024/0300-9831/a000673']
2036,32795267,The effect of problem-based learning after coronary heart disease - a randomised study in primary health care (COR-PRIM).,"BACKGROUND


Cardiac rehabilitation is effective after coronary heart disease (CHD). However, risk factors remain, and patients report fear for recurrence during recovery. Problem-based learning is a pedagogical method, where patients work self-directed in small groups with problem solving of real-life situations to manage CHD risk factors and self-care. We aimed to demonstrate the better effectiveness of problem-based learning over home-sent patient information for evaluating long-term effects of patient empowerment and self-care in patients with CHD. Hypothesis tested: One year of problem-based learning improves patients' empowerment- and self-efficacy, to change self-care compared to 1 year of standardised home-sent patient information after CHD.
METHODS


Patients (N = 157) from rural and urban areas in Sweden between 2011 and 2015 (78% male; age. 68 ± 8.5 years) with CHD verified by percutaneous coronary intervention (PCI) (70.1%) or coronary artery by-pass surgery (CABG) and CABG+PCI or myocardial infarction (29.9%) were randomly assigned to problem-based learning (experimental group; n = 79) or home-sent patient information (controls; n = 78). The problem-based learning intervention consisted of patient education in primary care by nurses tutoring groups of 6-9 patients on 13 occasions over 1 year. Controls received home-sent patient information on 11 occasions during the study year.
RESULTS


At one-year follow-up, the primary outcome, patient empowerment, did not significantly differ between the experimental group and controls. We found no significant differences between the groups regarding the secondary outcomes e.g. self-efficacy, although we found significant differences for body mass index (BMI) [- 0.17 (SD 1.5) vs. 0.50 (SD 1.6), P = 0.033], body weight [- 0.83 (SD) 4.45 vs. 1.14 kg (SD 4.85), P = 0.026] and HDL cholesterol [0.1 (SD 0.7) vs. 0.0 mmol/L (SD 0.3), P = 0.038] favouring the experimental group compared to controls.
CONCLUSIONS


The problem-based learning- and the home-sent patient information interventions had similar results regarding patient empowerment, self-efficacy, and well-being. However, problem-based learning exhibited significant effects on weight loss, BMI, and HDL cholesterol levels, indicating that this intervention positively affected risk factors compared to the home-sent patient information.
TRIAL REGISTRATION


NCT01462799 (February 2020).",2020,"At one-year follow-up, the primary outcome, patient empowerment, did not significantly differ between the experimental group and controls.","['primary health care (COR-PRIM', 'Patients (N\xa0=\u2009157) from rural and urban areas in Sweden between 2011 and 2015 (78% male; age', 'patients with CHD', '68\u2009±\u20098.5\u2009years) with CHD verified by percutaneous coronary intervention (PCI) (70.1%) or coronary artery by-pass surgery (CABG) and CABG+PCI or myocardial infarction (29.9']","['problem-based learning', 'problem-based learning (experimental group; n\u2009=\u200979) or home-sent patient information']","['body weight', 'weight loss, BMI, and HDL cholesterol levels', 'HDL cholesterol', 'body mass index (BMI']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]","[{'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}]",,0.0734807,"At one-year follow-up, the primary outcome, patient empowerment, did not significantly differ between the experimental group and controls.","[{'ForeName': 'Anita Kärner', 'Initials': 'AK', 'LastName': 'Köhler', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, SE-581 83, Linköping, Sweden. anita.karner@liu.se.'}, {'ForeName': 'Tiny', 'Initials': 'T', 'LastName': 'Jaarsma', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, SE-581 83, Linköping, Sweden.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Tingström', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, SE-581 83, Linköping, Sweden.'}, {'ForeName': 'Staffan', 'Initials': 'S', 'LastName': 'Nilsson', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, SE-581 83, Linköping, Sweden.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01647-2']
2037,32795310,"Effects of canola or olive oil on plasma lipids, lipoprotein-associated phospholipase A 2  and inflammatory cytokines in patients referred for coronary angiography.","BACKGROUND


The potential cardioprotective benefits of olive oil (OO) and canola oil (CO) consumption have been shown in some studies. The present study compared the effects of CO and OO on plasma lipids, some inflammatory cytokines, and lipoprotein-associated phospholipase A 2  (Lp-PLA 2 ) mass and activity in patients undergoing coronary angiography.
METHODS


The current randomized, controlled, parallel-arm, clinical trial involved 48 patients (44 men and 4 women, aged 57.63 ± 6.34 years) with at least one classic cardiovascular risk factor (hypertension, dyslipidemia, or diabetes) who referred for coronary angiography. Patients were randomly divided into two groups and received 25 mL/day refined olive oil (n = 24) or canola oil (n = 24) for 6 weeks. Plasma lipids, some selected inflammatory markers, and Lp-PLA 2  levels were measured at baseline and after the intervention.
RESULTS


CO consumption produced a significant reduction in plasma Lp-PLA 2  mass (- 0.97 ± 1.84 vs. 0.34 ± 1.57 ng/mL, p = 0.008 for CO and OO, respectively), whereas the mean changes in interleukine-6 concentration were significantly lower after OO consumption compared with CO (- 9.46 ± 9.46 vs. -0.90 ± 6.80 pg/mL, p = 0.008 for OO and CO, respectively). After 6 weeks of intervention, no significant changes were observed in plasma Lp-PLA 2  activity, complement C3, C4, or lipid profiles in the two intervention groups.
CONCLUSIONS


Comparing the two vegetable oils in subjects with cardiovascular risk factors showed that the consumption of olive oil is more effective in reducing the level of inflammatory cytokine interleukine-6, whereas canola oil was more effective in lowering Lp-PLA 2  levels; however, this finding should be interpreted with caution, because Lp-PLA 2  activity did not change significantly.
TRIAL REGISTRATION


IRCT20160702028742N5 at www.irct.ir (04/19/2019).",2020,"After 6 weeks of intervention, no significant changes were observed in plasma Lp-PLA 2  activity, complement C3, C4, or lipid profiles in the two intervention groups.
","['patients referred for coronary angiography', 'patients undergoing coronary angiography', 'subjects with cardiovascular risk factors', '48 patients (44 men and 4 women, aged 57.63\u2009±\u20096.34\u2009years) with at least one classic cardiovascular risk factor (hypertension, dyslipidemia, or diabetes) who referred for coronary angiography']","['25\u2009mL/day refined olive oil (n\u2009=\u200924) or canola oil', 'olive oil (OO) and canola oil (CO) consumption', 'canola or olive oil']","['Plasma lipids, some selected inflammatory markers, and Lp-PLA 2  levels', 'interleukine-6 concentration', 'plasma Lp-PLA 2  activity, complement C3, C4, or lipid profiles', 'plasma lipids, lipoprotein-associated phospholipase', 'plasma lipids, some inflammatory cytokines, and lipoprotein-associated phospholipase', 'plasma Lp-PLA 2  mass']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0439446', 'cui_str': 'mL/24h'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0054599', 'cui_str': 'canola oil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0330502', 'cui_str': 'Brassica napus'}]","[{'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0914069', 'cui_str': '1-alkyl-2-acetylglycerophosphocholine esterase'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009506', 'cui_str': 'Complement component C3'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0031671', 'cui_str': 'Phospholipase'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",48.0,0.138053,"After 6 weeks of intervention, no significant changes were observed in plasma Lp-PLA 2  activity, complement C3, C4, or lipid profiles in the two intervention groups.
","[{'ForeName': 'Nafiseh', 'Initials': 'N', 'LastName': 'Khandouzi', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, National Nutrition, and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, No. 7, Hafezi St., Farahzadi Blvd., Qods Town, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Zahedmehr', 'Affiliation': 'Cardiovascular Intervention Research Center, Rajaie Cardiovascular, Medical & Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Nasrollahzadeh', 'Affiliation': 'Department of Clinical Nutrition & Dietetics, National Nutrition, and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, Shahid Beheshti University of Medical Sciences, No. 7, Hafezi St., Farahzadi Blvd., Qods Town, Tehran, Iran. jnasrollahzadeh@gmail.com.'}]",Lipids in health and disease,['10.1186/s12944-020-01362-z']
2038,32795322,Preservation of swallowing in resected oral cavity squamous cell carcinoma: examining radiation volume effects (PRESERVE): study protocol for a randomized phase II trial.,"BACKGROUND


Patients with resected oral cavity squamous cell carcinoma (OCSCC) are often treated with adjuvant radiation (RT) ± concomitant chemotherapy based on pathological findings. Standard RT volumes include all surgically dissected areas, including the tumour bed and dissected neck. RT has significant acute and long-term toxicities including odynophagia, dysphagia, dermatitis and fibrosis. The goal of this study is to assess the rate of regional failure with omission of radiation to the surgically dissected pathologically node negative (pN0) hemi-neck(s) compared to historical control, and to compare oncologic outcomes, toxicity, and quality of life (QoL) profiles between standard RT volumes and omission of RT to the pN0 neck.
METHODS


This is a multicentre phase II study randomizing 90 patients with T1-4 N0-2 OCSCC with at least one pN0 hemi-neck in a 1:2 ratio between standard RT volumes and omission of RT to the pN0 hemi-neck(s). Patients will be stratified based on overall nodal status (nodal involvement vs. no nodal involvement) and use of concurrent chemotherapy. The primary endpoint is regional failure in the pN0 hemi-neck(s); we hypothesize that a 2-year regional recurrence of 20% or less will be achieved. Secondary endpoints include overall and progression-free survival, local recurrence, rate of salvage therapy, toxicity and QoL.
DISCUSSION


This study will provide an assessment of omission of RT to the dissected pN0 hemi-neck(s) on oncologic outcomes, QoL and toxicity. Results will inform the design of future definitive phase III trials.
TRIAL REGISTRATION


Clinicaltrials.gov identifier: NCT03997643 . Date of registration: June 25, 2019, Current version: 2.0 on July 11 2020.",2020,"Secondary endpoints include overall and progression-free survival, local recurrence, rate of salvage therapy, toxicity and QoL.
DISCUSSION


","['resected oral cavity squamous cell carcinoma', '90 patients with T1-4\u2009N0-2 OCSCC with at least one pN0 hemi-neck in a 1:2 ratio between standard RT volumes and omission of RT to the pN0 hemi-neck(s', 'Patients with resected oral cavity squamous cell carcinoma (OCSCC']",['adjuvant radiation (RT)\u2009±\u2009concomitant chemotherapy'],"['overall and progression-free survival, local recurrence, rate of salvage therapy, toxicity and QoL.\nDISCUSSION', 'oncologic outcomes, QoL and toxicity', 'oncologic outcomes, toxicity, and quality of life (QoL) profiles', 'regional failure in the pN0 hemi-neck(s); we hypothesize that a 2-year regional recurrence']","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0585362', 'cui_str': 'Squamous cell carcinoma of mouth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332396', 'cui_str': 'pN0 category'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332396', 'cui_str': 'pN0 category'}, {'cui': 'C1285521', 'cui_str': 'Hemi'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0439234', 'cui_str': 'year'}]",90.0,0.0722618,"Secondary endpoints include overall and progression-free survival, local recurrence, rate of salvage therapy, toxicity and QoL.
DISCUSSION


","[{'ForeName': 'Pencilla', 'Initials': 'P', 'LastName': 'Lang', 'Affiliation': 'Division of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada. pencilla.lang@lhsc.on.ca.'}, {'ForeName': 'Jessika', 'Initials': 'J', 'LastName': 'Contreras', 'Affiliation': 'Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, Florida, USA.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Kalman', 'Affiliation': 'Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, Florida, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Paterson', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'Houda', 'Initials': 'H', 'LastName': 'Bahig', 'Affiliation': ""Department of Radiation Oncology, Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Billfalk-Kelly', 'Affiliation': ""Department of Radiation Oncology, Eastern Health, St. John's, Newfoundland, Canada.""}, {'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Brennan', 'Affiliation': ""Saint Luke's Radiation Oncology Network, Dublin, Ireland.""}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Rock', 'Affiliation': 'Department of Radiation Oncology, Cork University Hospital, Cork, Ireland.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Read', 'Affiliation': 'Division of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'Varagur', 'Initials': 'V', 'LastName': 'Venkatesan', 'Affiliation': 'Division of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'Jinka', 'Initials': 'J', 'LastName': 'Sathya', 'Affiliation': 'Division of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Mendez', 'Affiliation': 'Division of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'S Danielle', 'Initials': 'SD', 'LastName': 'MacNeil', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Nichols', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Fung', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Mendez', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Western University, London, Ontario, Canada.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Winquist', 'Affiliation': 'Department of Medical Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Kuruvilla', 'Affiliation': 'Department of Medical Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Stewart', 'Affiliation': 'Department of Medical Oncology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warner', 'Affiliation': 'Division of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Mitchell', 'Affiliation': 'Division of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Theurer', 'Affiliation': 'School of Communication Sciences and Disorders, Western University, London, Ontario, Canada.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Palma', 'Affiliation': 'Division of Radiation Oncology, London Health Sciences Centre, 800 Commissioners Rd. E, London, ON, N6A 5W9, Canada.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01636-x']
2039,32795330,Auxora versus standard of care for the treatment of severe or critical COVID-19 pneumonia: results from a randomized controlled trial.,"BACKGROUND


Calcium release-activated calcium (CRAC) channel inhibitors stabilize the pulmonary endothelium and block proinflammatory cytokine release, potentially mitigating respiratory complications observed in patients with COVID-19. This study aimed to investigate the safety and efficacy of Auxora, a novel, intravenously administered CRAC channel inhibitor, in adults with severe or critical COVID-19 pneumonia.
METHODS


A randomized, controlled, open-label study of Auxora was conducted in adults with severe or critical COVID-19 pneumonia. Patients were randomized 2:1 to receive three doses of once-daily Auxora versus standard of care (SOC) alone. The primary objective was to assess the safety and tolerability of Auxora. Following FDA guidance, study enrollment was halted early to allow for transition to a randomized, blinded, placebo-controlled study.
RESULTS


In total, 17 patients with severe and three with critical COVID-19 pneumonia were randomized to Auxora and nine with severe and one with critical COVID-19 pneumonia to SOC. Similar proportions of patients receiving Auxora and SOC experienced ≥ 1 adverse event (75% versus 80%, respectively). Fewer patients receiving Auxora experienced serious adverse events versus SOC (30% versus 50%, respectively). Two patients (10%) receiving Auxora and two (20%) receiving SOC died during the 30 days after randomization. Among patients with severe COVID-19 pneumonia, the median time to recovery with Auxora was 5 days versus 12 days with SOC; the recovery rate ratio was 1.87 (95% CI, 0.72, 4.89). Invasive mechanical ventilation was needed in 18% of patients with severe COVID-19 pneumonia receiving Auxora versus 50% receiving SOC (absolute risk reduction = 32%; 95% CI, - 0.07, 0.71). Outcomes measured by an 8-point ordinal scale were significantly improved for patients receiving Auxora, especially for patients with a baseline PaO 2 /FiO 2  = 101-200.
CONCLUSIONS


Auxora demonstrated a favorable safety profile in patients with severe or critical COVID-19 pneumonia and improved outcomes in patients with severe COVID-19 pneumonia. These results, however, are limited by the open-label study design and small patient population resulting from the early cessation of enrollment in response to regulatory guidance. The impact of Auxora on respiratory complications in patients with severe COVID-19 pneumonia will be further assessed in a planned randomized, blinded, placebo-controlled study.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT04345614 . Submitted on 7 April 2020.",2020,"Similar proportions of patients receiving Auxora and SOC experienced ≥ 1 adverse event (75% versus 80%, respectively).","['patients with COVID-19', 'patients with severe COVID-19 pneumonia', 'adults with severe or critical COVID-19 pneumonia', 'severe or critical COVID-19 pneumonia', '17 patients with severe and three with critical COVID-19 pneumonia']","['once-daily Auxora versus standard of care (SOC) alone', 'Auxora versus standard of care', 'CRAC channel inhibitor', 'placebo']","['Invasive mechanical ventilation', 'respiratory complications', 'median time to recovery with Auxora', 'recovery rate ratio', 'safety and tolerability of Auxora', 'serious adverse events', '8-point ordinal scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C4277604', 'cui_str': 'Calcium Release-Activated Calcium Channels'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",17.0,0.297157,"Similar proportions of patients receiving Auxora and SOC experienced ≥ 1 adverse event (75% versus 80%, respectively).","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Henry Ford Hospital System, Detroit, MI, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Bruen', 'Affiliation': 'Regions Hospital, Health Partners, St. Paul, MN, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schnaus', 'Affiliation': 'Regions Hospital, Health Partners, St. Paul, MN, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Princeton Pharmatech, Princeton, NJ, USA.'}, {'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Lind', 'Affiliation': 'Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Stoecker', 'Affiliation': 'Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Stauderman', 'Affiliation': 'CalciMedica, Inc., 505 Coast Blvd. South Suite 202, La Jolla, CA, 92037, USA.'}, {'ForeName': 'Sudarshan', 'Initials': 'S', 'LastName': 'Hebbar', 'Affiliation': 'CalciMedica, Inc., 505 Coast Blvd. South Suite 202, La Jolla, CA, 92037, USA. sudarshan@calcimedica.com.'}]","Critical care (London, England)",['10.1186/s13054-020-03220-x']
2040,32795364,Evaluation of Mental Health First Aid from the Perspective Of Workplace End UseRs-EMPOWER: protocol of cluster randomised trial phase.,"BACKGROUND


Mental Health First Aid (MHFA) is a mental health intervention that teaches people how to identify, understand and help someone who may be experiencing a mental health issue. Reviews of the implementation of MHFA found between 68 and 88% of trained Mental Health First Aiders had used their skills when in contact with someone experiencing mental health difficulties. Reviews evaluating the impact of MHFA suggest positive outcomes. However, to date, there has been no systematic, rigorous evaluation of the impact of MHFA on recipients of the intervention, the organisations providing it and the cost-effectiveness of MHFA overall. This trial will evaluate the effectiveness and cost-effectiveness of MHFA.
METHODS


The study is a multi-centred, two-arm clustered randomised controlled trial. Organisations will be randomly allocated to the control or intervention (estimated sample size 800 recipients). The intervention is the standard MHFA intervention provided by Mental Health First Aid England (MHFAE). The control condition will be organisations having a brief consultation from MHFAE on promoting mental health and well-being in the workplace. The primary outcome is health seeking behaviour, measured using the Actual Help Seeking Questionnaire, at 6 months' follow-up. Data collection will be undertaken at baseline (T0), post-intervention-up to 3 months (T1), at 6 months (T2), 12 months (T3) and 24 months (T4). The primary analysis will be conducted on those participants who receive MHFA, a per protocol analysis.
DISCUSSION


The study is the first to evaluate the effect of MHFA in the workplace on employees with direct and indirect experience of the intervention, when compared with usual practice. Being also the first to assess, systematically, the social impact of MHFA and investigate its cost-effectiveness adds to the originality of the study. The study promises to yield important data, as yet unknown, regarding the effectiveness, cost-effectiveness, implementation issues, and the sustainability of MHFA in the workplace.
TRIAL REGISTRATION


Clinicaltrials.gov NCT04311203 . Registered on 17 March 2020.",2020,"The primary outcome is health seeking behaviour, measured using the Actual Help Seeking Questionnaire, at 6 months' follow-up.",[],"['standard MHFA intervention provided by Mental Health First Aid England (MHFAE', 'MHFA']","['health seeking behaviour, measured using the Actual Help Seeking Questionnaire']",[],"[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0016143', 'cui_str': 'First aid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C1321107', 'cui_str': 'Health seeking behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.134721,"The primary outcome is health seeking behaviour, measured using the Actual Help Seeking Questionnaire, at 6 months' follow-up.","[{'ForeName': 'Opeyemi', 'Initials': 'O', 'LastName': 'Atanda', 'Affiliation': 'London South Bank University, London, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Callaghan', 'Affiliation': 'London South Bank University, London, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Carter', 'Affiliation': 'University of Nottingham, Institute of Mental Health and School of Health Sciences, Nottingham, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Durcan', 'Affiliation': 'Centre for Mental Health, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': ""O'Shea"", 'Affiliation': 'London South Bank University, London, UK.'}, {'ForeName': 'Steve D', 'Initials': 'SD', 'LastName': 'Brown', 'Affiliation': 'Nottingham Business School, Nottingham Trent University, Nottingham, UK.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Reavey', 'Affiliation': 'London South Bank University, London, UK.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Vangeli', 'Affiliation': 'London South Bank University, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'White', 'Affiliation': ""Population Health Research Institute, St George's University of London, London, UK.""}, {'ForeName': 'Kerry V', 'Initials': 'KV', 'LastName': 'Wood', 'Affiliation': 'London South Bank University, London, UK. woodk6@lsbu.ac.uk.'}]",Trials,['10.1186/s13063-020-04636-0']
2041,32793868,Pediatric Ice Pop Administration to Improve Patient Experience Scores.,"Objective


To assess the impact on patient experience scores of giving an ice pop (Popsicle, Good Humor-Breyers, Oakland, CA) to patients in a pediatric emergency department (ED).
Patients and Methods


A prospective two-center trial was conducted at a tertiary academic pediatric ED and a community ED from January 1, 2018, through March 31, 2018. The intervention arm gave an ice pop to all eligible patients 0 to 14 years of age on even-numbered days versus conventional practice on odd-numbered days. Press Ganey top box scores were then compared.
Results


Of 4574 pediatric (0 to 14 years of age) patient visits, patient experience surveys were delivered to 1346 families (29.4%) and 152 were returned (11.3%). Eighty-four surveys were returned for even-numbered day visits and 68 for odd-numbered day visits. There was a significant increase in patient experience scores associated with ice pop administration days for questions that asked about doctor's concern for comfort 70.2% versus 57.4%  (P=. 05), doctor's courtesy 76.2% versus 61.8% ( P =.04), and doctor taking time to listen 72.6% versus 57.4% ( P =.03).
Conclusion


A low-cost intervention resulted in significantly increased patient experience scores in select domains. Popsicle administration was a simple intervention which was easily instituted in both academic and community ED settings. Further study should explore the durability of the effect.",2020,"There was a significant increase in patient experience scores associated with ice pop administration days for questions that asked about doctor's concern for comfort 70.2% versus 57.4%  (P=. 05), doctor's courtesy 76.2% versus 61.8% ( P =.04), and doctor taking time to listen 72.6% versus 57.4% ( P =.03).
","['patients in a pediatric emergency department (ED', 'Patients and Methods\n\n\nA prospective two-center trial was conducted at a tertiary academic pediatric ED and a community ED from January 1, 2018, through March 31, 2018']","['ice pop (Popsicle, Good Humor-Breyers, Oakland, CA']","['patient experience scores', 'doctor taking time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C3853215', 'cui_str': 'Popsicle'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0020168', 'cui_str': 'Humor'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",84.0,0.0333194,"There was a significant increase in patient experience scores associated with ice pop administration days for questions that asked about doctor's concern for comfort 70.2% versus 57.4%  (P=. 05), doctor's courtesy 76.2% versus 61.8% ( P =.04), and doctor taking time to listen 72.6% versus 57.4% ( P =.03).
","[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Finn', 'Affiliation': 'Department of Emergency Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Voelkel', 'Affiliation': 'Department of Emergency Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'M Fernanda', 'Initials': 'MF', 'LastName': 'Bellolio', 'Affiliation': 'Department of Emergency Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Molly M', 'Initials': 'MM', 'LastName': 'Jeffery', 'Affiliation': 'Department of Emergency Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Wiswell', 'Affiliation': 'Department of Emergency Medicine, Mayo Clinic Health System, La Crosse, WI.'}]","Mayo Clinic proceedings. Innovations, quality & outcomes",['10.1016/j.mayocpiqo.2020.04.011']
2042,32793869,Using Shared Decision-Making Tools and Patient-Clinician Conversations About Costs.,"Objective


To determine how shared decision-making (SDM) tools used during clinical encounters that raise cost as an issue impact the incidence of cost conversations between patients and clinicians.
Patients and Methods


A randomly selected set of 220 video recordings of clinical encounters were analyzed. Videos were obtained from eight practice-based randomized clinical trials and one quasi-randomized clinical trial (pre- and post-) comparing care with and without SDM tools. The secondary analysis took place in 2018 from trials ran between 2007 and 2015.
Results


Most patient participants were white (85%), educated (38% completed college), middle-aged (mean age 56 years), and female (61%). There were 105 encounters with and 115 without the SDM tool. Encounters with SDM tools were more likely to include both general cost conversations (62% vs 36%, odds ratio [OR]: 9.6; 95% CI: 4 to 26) as well as conversations on medication costs specifically (89% vs 51%,  P =.01). However, clinicians using SDM tools were less likely to address cost issues during the encounter (37% vs 51%,  P =.04). Encounters with patients with less than a college degree were also associated with a higher incidence of cost conversations.
Conclusion


Using SDM tools that raise cost as an issue increased the occurrence of cost conversations but was less likely to address cost issues or offer potential solutions to patients' cost concerns. This result suggests that SDM tools used during the consultation can trigger cost conversations but are insufficient to support them.",2020,"Encounters with SDM tools were more likely to include both general cost conversations (62% vs 36%, odds ratio [OR]: 9.6; 95% CI: 4 to 26) as well as conversations on medication costs specifically (89% vs 51%,  P =.01).","['105 encounters with and 115 without the SDM tool', 'Most patient participants were white (85%), educated (38% completed college), middle-aged (mean age 56 years), and female (61', '2018 from trials ran between 2007 and\xa02015']",[],"['medication costs', 'general cost conversations', 'cost conversations']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",[],"[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.044829,"Encounters with SDM tools were more likely to include both general cost conversations (62% vs 36%, odds ratio [OR]: 9.6; 95% CI: 4 to 26) as well as conversations on medication costs specifically (89% vs 51%,  P =.01).","[{'ForeName': 'Nataly R', 'Initials': 'NR', 'LastName': 'Espinoza Suarez', 'Affiliation': 'Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'LaVecchia', 'Affiliation': 'Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Oscar J', 'Initials': 'OJ', 'LastName': 'Ponce', 'Affiliation': 'Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Fischer', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Wilson', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Celia C', 'Initials': 'CC', 'LastName': 'Kamath', 'Affiliation': 'Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'LeBlanc', 'Affiliation': 'Department of Family Medicine and Emergency Medicine, Laval University, Quebec, Canada.'}, {'ForeName': 'Victor M', 'Initials': 'VM', 'LastName': 'Montori', 'Affiliation': 'Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Brito', 'Affiliation': 'Knowledge and Evaluation Research (KER) Unit, Mayo Clinic, Rochester, MN.'}]","Mayo Clinic proceedings. Innovations, quality & outcomes",['10.1016/j.mayocpiqo.2020.04.013']
2043,32794392,Effect of a continuous mechanical polishing protocol and toothbrushing on the surface roughness of acrylic resin teeth.,"PURPOSE


To evaluate in vitro the effect of a continuous mechanical polishing protocol, performed in different periods, on the surface roughness of acrylic resin teeth subjected to toothbrushing (Br).
METHODS


Artificial acrylic teeth (n=30) were randomly divided into three groups according to the polishing protocol and toothbrushing (Br): Br; Br+Pol15 (Br associated with a biweekly polishing); Br+Pol30 (monthly polishing). Br group was subjected to a total of 89,000 brushing cycles. Polishing was performed by applying aluminum oxide paste to the specimens with a felt wheel coupled to an electric motor (5 seconds, 3,000 rpm) after each 741 and 1482 brushing cycles for Br+Pol15 and Br+Pol30 groups, respectively. A contact profilometer and an analytical balance were used to measure surface roughness and mass changes before (T0) and after 1, 2, 3, and 5 years (T4) of simulated toothbrushing. Scanning electron microscopy (SEM) images were obtained. Differences among groups were tested by means of two-way ANOVA/Bonferroni tests (P= 0.05).
RESULTS


Toothbrushing gradually increased surface roughness [T0 - 0.16 (0.01); T4 - 0.30 (0.10); P< 0.001]. The tested polishing promoted a significant roughness reduction (P< 0.001) for both biweekly [T4 - 0.09 (0.01) ] and monthly [T4 - 0.13 (0.02) ] regimes, and it did not influence the mass alterations caused by toothbrushing. SEM showed a smoother aspect of the material surface subjected to biweekly polishing with less defects caused by brushing abrasiveness.
CLINICAL SIGNIFICANCE


In order to reduce the effects of various deleterious factors on the properties of acrylic resin for removable prostheses during their period of use, a frequent mechanical polishing protocol could increase clinical performance and extend the lifespan of these appliances. Furthermore, a polishing protocol by means of a simple technique could be employed by patients in a home environment.",2020,"SEM showed a smoother aspect of the material surface subjected to biweekly polishing with less defects caused by brushing abrasiveness.
","['Artificial acrylic teeth', 'n=30', 'acrylic resin teeth']","['aluminum oxide paste', 'continuous mechanical polishing protocol', 'polishing protocol and toothbrushing (Br', 'continuous mechanical polishing protocol and toothbrushing']","['surface roughness', 'roughness reduction']","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0001222', 'cui_str': 'Acrylic Resins'}]","[{'cui': 'C1253849', 'cui_str': 'Aluminum Oxide Paste'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",30.0,0.0157851,"SEM showed a smoother aspect of the material surface subjected to biweekly polishing with less defects caused by brushing abrasiveness.
","[{'ForeName': 'Giovanna G', 'Initials': 'GG', 'LastName': 'Guimarães', 'Affiliation': 'Private practice.'}, {'ForeName': 'Marina F', 'Initials': 'MF', 'LastName': 'Sarte', 'Affiliation': 'Private practice.'}, {'ForeName': 'Joel O', 'Initials': 'JO', 'LastName': 'Barreto', 'Affiliation': 'Graduate student, Department of Restorative Dentistry, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Karina M', 'Initials': 'KM', 'LastName': 'de Freitas-Pontes', 'Affiliation': 'Department of Restorative Dentistry, Federal University of Ceará, Fortaleza, Brazil.'}, {'ForeName': 'Romulo R', 'Initials': 'RR', 'LastName': 'Regis', 'Affiliation': 'Department of Restorative Dentistry, Federal University of Ceará, Fortaleza, CE, Brazil, romuloregis@hotmail.com.'}]",American journal of dentistry,[]
2044,32794396,Dentin moisture does not influence postoperative sensitivity in posterior restorations: A double-blind randomized clinical trial.,"PURPOSE


This double-blind, randomized clinical trial evaluated the influence of dentin moisture on postoperative sensitivity (POS) in posterior restorations using a simplified etch-and-rinse adhesive, until 12 months of clinical service.
METHODS


90 restorations were inserted in 45 patients to treat carious lesions or to replace existing posterior restorations with a depth ≥ 3 mm. After cavity preparation, the simplified etch-and-rinse adhesive (Adper Single Bond 2) was applied on dry or wet dentin followed by a bulk-fill resin composite (Filtek Bulk Fill) under rubber dam isolation. The patient's spontaneous and stimulated POS was evaluated at baseline and after 7 days, 6 months, and 12 months of clinical evaluation. The secondary parameters (marginal discoloration, marginal adaptation, fracture and recurrence of caries) were evaluated by World Dental Federation (FDI) criteria after 7 days, 6 and 12 months of clinical evaluation.
RESULTS


No significant spontaneous and stimulated POS was observed when dry and wet dentin were compared (P> 0.05). A significant and higher risk of spontaneous POS (18.6%; 95% CI 9.7 to 32.6) occurred up to 48 hours after restoration placement for both groups when compared to all evaluation times (P< 0.03). However, the intensity of POS was mild at up to 48 hours with a difference between the dry and wet dentin groups (P> 0.79). When secondary parameters were evaluated, no significant difference between the groups were observed (P> 0.05).
CLINICAL SIGNIFICANCE


The moisture level of the dentin substrate in posterior restorations does not influence POS in bulk-fill resin composite posterior restorations when associated with an etch-and-rinse ethanol-based adhesive system.",2020,"However, the intensity of POS was mild at up to 48 hours with a difference between the dry and wet dentin groups (P> 0.79).","['90 restorations were inserted in 45 patients to treat carious lesions or to replace existing posterior restorations with a depth ≥ 3 mm', 'posterior restorations']","['dentin moisture', 'Dentin moisture']","['intensity of POS', 'spontaneous and stimulated POS', ""patient's spontaneous and stimulated POS"", 'postoperative sensitivity (POS', 'higher risk of spontaneous POS', 'secondary parameters (marginal discoloration, marginal adaptation, fracture and recurrence of caries']","[{'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]",90.0,0.306561,"However, the intensity of POS was mild at up to 48 hours with a difference between the dry and wet dentin groups (P> 0.79).","[{'ForeName': 'Andrea S', 'Initials': 'AS', 'LastName': 'Castro', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Bianca M', 'Initials': 'BM', 'LastName': 'Maran', 'Affiliation': 'Postgraduate Program in Dentistry, School of Dentistry, University of North Paraná, Londrina, Paraná, Brazil.'}, {'ForeName': 'Mario F', 'Initials': 'MF', 'LastName': 'Gutiérrez', 'Affiliation': 'Faculty of Dentistry, University of the Andes, Santiago, Chile.'}, {'ForeName': 'Eveline C', 'Initials': 'EC', 'LastName': 'Martini', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Fabiana Ds', 'Initials': 'FD', 'LastName': 'Dreweck', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Luján', 'Initials': 'L', 'LastName': 'Mendez-Bauer', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa, Ponta Grossa, PR, Brazil, aloguercio@hotmail.com.'}]",American journal of dentistry,[]
2045,32794398,The relative clinical efficacy of three 0.454% stannous fluoride dentifrices for the treatment of gingivitis over 3 months.,"PURPOSE


To assess the safety and efficacy of three stannous fluoride (SnF2) dentifrices in the reduction of gingivitis versus a negative control dentifrice.
METHODS


This was a randomized, controlled, double-blind, four-treatment parallel group study. 120 healthy adult volunteers with established gingivitis were enrolled and randomly assigned to one of four dentifrice treatment groups (30/group): 0.454% SnF2 + citrate dentifrice A; 0.454% SnF2 + sodium hexametaphosphate dentifrice B; 0.454% SnF2 + pyrophosphate dentifrice C; or 0.76% sodium monofluorophosphate negative control group. Subjects brushed with their assigned dentifrice and an assigned regular manual toothbrush (Oral-B Indicator) for 1 minute twice daily for 12 weeks. Number of gingival bleeding sites and Löe-Silness Gingival Index (LSGI) scores were assessed at baseline and at Weeks 2, 4 and 12.
RESULTS


120 subjects were enrolled and 112 completed the trial. Subjects had an average age (SD) of 39.31 (14.5) years; 67% of subjects were female. Overall baseline means (SD) were 81.2 (25.6) for number of bleeding sites and 1.51 (0.197) for mean LSGI score. Baseline disease levels were balanced across all treatment groups. At Week 2, SnF2 dentifrices A and B demonstrated a significant reduction in gingival bleeding sites versus the negative control; however, SnF2 dentifrice C was not significantly different from the negative control (P= 0.15). At Weeks 4 and 12, all SnF2 dentifrices demonstrated a significant gingival bleeding site reduction versus the negative control (P< 0.001). At Weeks 2, 4 and 12, the SnF2 dentifrices were rank ordered dentifrice A > dentifrice B > dentifrice C for reduction in gingival bleeding sites (P< 0.001). The same trends were seen for LSGI scores.
CLINICAL SIGNIFICANCE


In this 12-week clinical study, all 0.454% SnF2 dentifrices delivered statistically significant reductions in the number of gingival bleeding sites relative to the negative control. Importantly, statistically significant efficacy differences were observed among the three 0.454% SnF2 dentifrices, demonstrating the important role that differences in formulation have on clinical efficacy.",2020,A > dentifrice B > dentifrice C for reduction in gingival bleeding sites (P< 0.001).,"['Subjects had an average age (SD) of 39.31 (14.5) years; 67% of subjects were female', '120 subjects were enrolled and 112 completed the trial', '120 healthy adult volunteers with established gingivitis']","['stannous fluoride (SnF2) dentifrices', 'stannous fluoride dentifrices', 'SnF2 + pyrophosphate dentifrice C', 'SnF2 dentifrices were rank ordered dentifrice', 'sodium monofluorophosphate negative control', 'dentifrice B > dentifrice C', 'SnF2 + citrate dentifrice A; 0.454% SnF2 + sodium hexametaphosphate dentifrice B']","['Baseline disease levels', 'LSGI scores', 'number of gingival bleeding sites', 'gingival bleeding sites', 'safety and efficacy', 'gingival bleeding site reduction', 'Number of gingival bleeding sites and Löe-Silness Gingival Index (LSGI) scores', 'Overall baseline means (SD']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0443211', 'cui_str': 'Established'}]","[{'cui': 'C0038143', 'cui_str': 'Stannous Fluoride'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0034320', 'cui_str': 'Pyrophosphate'}, {'cui': 'C0667477', 'cui_str': 'TNFRSF11A protein, human'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0142890', 'cui_str': 'sodium monofluorophosphate'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008857', 'cui_str': 'Citrates'}, {'cui': 'C0074759', 'cui_str': 'sodium polymetaphosphate'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0017565', 'cui_str': 'Bleeding gums'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",120.0,0.0258565,A > dentifrice B > dentifrice C for reduction in gingival bleeding sites (P< 0.001).,"[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'He', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA, he.t@pg.com.'}, {'ForeName': 'Sushma', 'Initials': 'S', 'LastName': 'Nachnani', 'Affiliation': 'University Health Resources Group, Whittier, CA, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'University Health Resources Group, Whittier, CA, USA.'}, {'ForeName': 'Yuanshu', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Grender', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Farrell', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sagel', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA.'}, {'ForeName': 'Aaron R', 'Initials': 'AR', 'LastName': 'Biesbrock', 'Affiliation': 'The Procter & Gamble Company, Mason, OH, USA.'}]",American journal of dentistry,[]
2046,32794478,Methylprednisolone acetate injection with casting versus casting alone for the treatment of De-Quervain's Tenosynovitis: a randomized controlled trial.,"OBJECTIVE


To compare the success of treatment between thumb spica cast with ""methylprednisolone acetate injection"" versus thumb spica cast alone for the treatment of de Quervain's disease as functional outcomes, complications and patient compliance.
METHODS


A single blinded randomized controlled trial using a probability sampling technique was conducted from January 2014 to h February 2017at the Orthopaedic Unit II, King Edward Medical University / Mayo Hospital, Lahore. A total of 134 patients of both genders, between 30-60 years of age presented with wrist pain and diagnosed de Quervain's disease, were included in the study. Patients were randomly divided into two group by the computer allocation method. Patients in Group-A received thumb spica cast with methylprednisolone acetate and xylocaine injection while patients in Group-B were treated with thumb spica cast alone. The outcome variable was frequency of successful treatment which was noted and compared among the groups.
RESULTS


Amongst the total 134 patients, the age of the patients ranged from 30 to 60 years with a mean of 37.16±5.15 years. Most of the patients were aged between 30 40 years (78.8%) followed by 41-50 years (21.2%). There were 38 (28.4%) male and 96 (71.6%) female patients in the study group with a male to female ratio of 1:2.5. In group-A mean VAS and Quick DASH score before treatment and after the treatment was statistically significant (p-value <0.001). In group-B mean VAS and Quick DASH score before and after the treatment was also significant (p-value <0.001) ( Table-2).
CONCLUSIONS


The effectiveness of treatment was significantly higher in patients treated with thumb spica cast with methylprednisolone acetate injection as compared to thumb spica cast alone.",2020,In group-A mean VAS and Quick DASH score before treatment and after the treatment was statistically significant (p-value <0.001).,"['total 134 patients, the age of the patients ranged from 30 to 60 years with a mean of 37.16±5.15 years', ""De-Quervain's Tenosynovitis"", 'There were 38 (28.4%) male and 96 (71.6%) female patients in the study group with a male to female ratio of 1:2.5', 'January 2014 to h February 2017at the Orthopaedic Unit II, King Edward Medical University / Mayo Hospital, Lahore', 'patients were aged between 30 40 years (78.8%) followed by 41-50 years (21.2', ""134 patients of both genders, between 30-60 years of age presented with wrist pain and diagnosed de Quervain's disease, were included in the study""]","['methylprednisolone acetate injection"" versus thumb spica cast alone', 'probability sampling technique', 'Methylprednisolone acetate injection with casting versus casting alone', 'thumb spica cast alone', 'methylprednisolone acetate injection', 'thumb spica cast with methylprednisolone acetate and xylocaine injection']","['frequency of successful treatment', 'mean VAS and Quick DASH score']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0149870', 'cui_str': 'Radial styloid tenosynovitis'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0221785', 'cui_str': 'Pain in wrist'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0600901', 'cui_str': 'Methylprednisolone acetate'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0040067', 'cui_str': 'Thumb structure'}, {'cui': 'C1289821', 'cui_str': 'Spica cast'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0699094', 'cui_str': 'Xylocaine'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.046391,In group-A mean VAS and Quick DASH score before treatment and after the treatment was statistically significant (p-value <0.001).,"[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Akhtar', 'Affiliation': 'Department of Orthopaedic Surgery, King Edward Medical University, Lahore, Pakistan.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Faraz Ul Hassan Shah Gillani', 'Affiliation': 'Department of Orthopedic Surgery, King Edward Medical University, Mayo Hospital, Lahore.'}, {'ForeName': 'Rana Dilawaiz', 'Initials': 'RD', 'LastName': 'Nadeem', 'Affiliation': 'Department of Orthopaedic Surgery, King Edward Medical University, Lahore, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Tasneem', 'Affiliation': 'Department of Orthopedic Surgery, King Edward Medical University / Mayo Hospital, Lahore, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.293180']
2047,32794480,"Effect of nursing led discharge instructions on improvement of post discharge care management in heart failure patients at tertiary care hospital of Karachi, Pakistan.","Objectives


To assess the impact of nursing discharge instructions on post-discharge care management in heart failure patients.
METHODS


The quasi- experimental non-randomized study was conducted at the National Institute of Cardiovascular Diseases, Karachi, from January to December 2017, and comprised in-patients suffering from heart failure. They were divided into two equal groups. In the intervention group, discharge instructions and written material was thoroughly given by the nurses other than routine existing instructions for effective post-discharge care management. The control group received discharged instructions under existing routine. Data was analysed using SPSS 21.
RESULTS


Of the 80 patients, there were 40(50%) in each group with no significant difference in terms of age, gender and education (p>0.05 each). Regarding awareness and control of the disease, adherence with medication and proper management of their illness, the intervention group had higher level of competency than the control group (p=0.001).
CONCLUSIONS


Provision of nursing interventions to educate the patient of heart failure during hospitalisation, on discharge, follow-up day and continuous guidance on telephone significantly improved the post-discharge care management of the patients.",2020,"Regarding awareness and control of the disease, adherence with medication and proper management of their illness, the intervention group had higher level of competency than the control group (p=0.001).
","['heart failure patients', '80 patients', 'heart failure patients at tertiary care hospital of Karachi, Pakistan', 'National Institute of Cardiovascular Diseases, Karachi, from January to December 2017, and comprised in-patients suffering from heart failure']","['nursing led discharge instructions', 'discharged instructions under existing routine', 'nursing discharge instructions']",[],"[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]",[],,0.0321335,"Regarding awareness and control of the disease, adherence with medication and proper management of their illness, the intervention group had higher level of competency than the control group (p=0.001).
","[{'ForeName': 'Zafar', 'Initials': 'Z', 'LastName': 'Iqbal', 'Affiliation': 'Jinnah Medical and Dental College Hospital, Karachi, Pakistan.'}, {'ForeName': 'Munnaza', 'Initials': 'M', 'LastName': 'Parveen', 'Affiliation': 'Jinnah College of Nursing, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Azhar', 'Affiliation': 'Lahore School of Nursing, The University of Lahore, Lahore, Pakistan.'}, {'ForeName': 'Mussarat', 'Initials': 'M', 'LastName': 'Parveen', 'Affiliation': 'Federal Government Public School Cantt. Garrision, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Afzal', 'Affiliation': 'Lahore School of Nursing, The University of Lahore, Lahore, Pakistan.'}, {'ForeName': 'Muhammad Fayyaz', 'Initials': 'MF', 'LastName': 'Awan', 'Affiliation': 'Jinnah College of Nursing, Karachi, Pakistan.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Dow University of Health Sciences, Karachi, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.10911']
2048,32794481,Comparison of Cyriax manipulation with traditional physical therapy for the management of cervical discogenic problems. A randomized control trial.,"OBJECTIVE


To determine and compare the clinical outcome of Cyriax manipulation and traditional physical therapy for the treatment of cervical discogenic problems in terms of pain, range of motion and disability.
METHODS


The randomised controlled trial was conducted at Benazir Bhutto Hospital, Rawalpindi, Pakistan, from January to June, 2018, and comprised patients having prolapsed intervertebral disc with neck or arm pain who were then randomly allocated into control and experimental groups using the sealed envelope method. The control group received cervical isometrics 10 repetitions ×1 set, 4 days/week and targeted muscle strechings 10 repetition × 1 set/day for 4 days/week. The experimental group received 10 min pre-manipulative massage and Cyriax manipulation protocol. Data was analysed using SPSS 20.
RESULTS


Of the 40 subjects, there were 20(50%) in each of the two groups. The experimental group showed significance difference in terms of numeric pain rating scale, range of motion and the neck disability index (p<0.05 each).
CONCLUSIONS


Cyriax manipulation was found to be significantly better than the traditional treatment of physiotherapy for cervical discogenic pain.",2020,"The experimental group showed significance difference in terms of numeric pain rating scale, range of motion and the neck disability index (p<0.05 each).
","['Benazir Bhutto Hospital, Rawalpindi, Pakistan, from January to June, 2018, and comprised patients having prolapsed intervertebral disc with neck or arm pain who', 'cervical discogenic problems', '40 subjects']","['Cyriax manipulation with traditional physical therapy', '10 min pre-manipulative massage and Cyriax manipulation protocol', 'Cyriax manipulation and traditional physical therapy']","['numeric pain rating scale, range of motion and the neck disability index (p<0.05 each', 'pain, range of motion and disability']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0242362', 'cui_str': 'Intervertebral disc prolapse'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0239377', 'cui_str': 'Pain in upper limb'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0550383,"The experimental group showed significance difference in terms of numeric pain rating scale, range of motion and the neck disability index (p<0.05 each).
","[{'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Razzaq', 'Affiliation': 'Riphah College of Rehabilitation Sciences, Riphah International university Islamabad, Pakistan.'}, {'ForeName': 'Abdul Ghafoor', 'Initials': 'AG', 'LastName': 'Sajjad', 'Affiliation': 'Faculty of Health and Medical Sciences, Riphah College of Rehabilitation Sciences, Riphah International University, Islamabad, Pakistan.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Yasin', 'Affiliation': 'THQ, Pindi, Bhattian, Punjab, Pakistan.'}, {'ForeName': 'Ramsha', 'Initials': 'R', 'LastName': 'Tariq', 'Affiliation': 'Railway General Hospital, Rawalpindi, Pakistan.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Ashraf', 'Affiliation': 'Sharif Medical and Surgical Complex, Sahiwal, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.13250']
2049,32794482,Addition of bismuth to standard triple therapy for Helicobacter pylori eradication: a randomised controlled trial.,"OBJECTIVE


To compare the effect of addition of bismuth to the standard triple therapy for eradication of Helicobacter pylori (H. pylori) in a randomised controlled trial.
METHODS


The study was performed from June 2018-May 2019, in the two outpatient departments located at two different campuses of Ziauddin university hospitals (ZUH) Karachi. Ethical approval was obtained from the Ethics Review Committee of ZUH. It was designed as a randomized control trial in a parallel fashion. Arm A received triple therapy including amoxicillin, clarithromycin, and omeprazole for two weeks and Arm B received quadruple therapy adding colloidal bismuth subcitrate to the triple therapy. A stool antigen test was done six weeks post treatment to confirm H. pylori eradication.
RESULTS


A total of 196 participants were included, out of which 102(52%) were males and 94 (48%) were females. Among the patients receiving quadruple therapy, 92/98(93.8%) had negative posttreatment stool antigen results, while among triple therapy recipients 83/98 (84.6%) had negative stool antigen results, according to intention-to-treat analysis (p value=0.038; odds ratio 2.77, 95% CI 1.03-7.47). However, p-value changed to 0.082 (odds ratio 2.40, 95% CI 0.87-6.60) in per-protocol analysis as stool antigen results were not available in two patients in the triple therapy arm. No difference in the side-effect profiles of either arm was noted.
CONCLUSIONS


Eradication rates of H. pylori may be modestly improved by addition of bismuth to the standard triple therapy.
Clinical Trial Number


03968302 (clinicaltrials.gov).",2020,"Among the patients receiving quadruple therapy, 92/98(93.8%) had negative posttreatment stool antigen results, while among triple therapy recipients 83/98 (84.6%) had negative stool antigen results, according to intention-to-treat analysis (p value=0.038; odds ratio 2.77, 95% CI 1.03-7.47).","['June 2018-May 2019, in the two outpatient departments located at two different campuses of Ziauddin university hospitals (ZUH) Karachi', 'A total of 196 participants were included, out of which 102(52%) were males and 94 (48%) were females']","['bismuth to standard triple therapy', 'bismuth', 'amoxicillin, clarithromycin, and omeprazole']","['negative posttreatment stool antigen results', 'Helicobacter pylori eradication', 'negative stool antigen results']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",196.0,0.357975,"Among the patients receiving quadruple therapy, 92/98(93.8%) had negative posttreatment stool antigen results, while among triple therapy recipients 83/98 (84.6%) had negative stool antigen results, according to intention-to-treat analysis (p value=0.038; odds ratio 2.77, 95% CI 1.03-7.47).","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Asim', 'Affiliation': 'Department of Gastroenterology, Ziauddin University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Khurram', 'Initials': 'K', 'LastName': 'Baqai', 'Affiliation': 'Department of Gastroenterology, Ziauddin University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Zaigham', 'Initials': 'Z', 'LastName': 'Abbas', 'Affiliation': 'Department of Gastroenterology, Ziauddin University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Nasir', 'Initials': 'N', 'LastName': 'Laique', 'Affiliation': 'Department of Gastroenterology, Ziauddin University Hospital, Karachi, Pakistan.'}, {'ForeName': 'Shoukat Ali', 'Initials': 'SA', 'LastName': 'Samejo', 'Affiliation': 'Department of Gastroenterology, Ziauddin University Hospital, Karachi, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.55396']
2050,32790671,Increasing adverse drug reaction reporting-How can we do better?,"Adverse drug reactions (ADRs) are associated with morbidity and mortality worldwide. Although national systems for reporting ADRs exist there is a low reporting rate. The aim of the current study was to evaluate an intervention plan for improving ADRs reporting among medical professionals (physicians and nurses). A multicentre intervention study was conducted, in which one medical centre was randomly assigned to the intervention group and two medical centres to the control group. The study consisted of 3 phases: baseline data collection, intervention and follow-up of the reporting rate. The questionnaire that was filled in at base line and at the end of study, contained questions about personal/professional demographic variables, and statements regarding knowledge of and behaviour toward ADRs reporting. The intervention program consisted of posters, lectures, distant electronic learning and reminders. An increase in the number of ADRs reports was noted in the intervention group (74 times higher than in the control group) during the intervention period, which was gradually decreased with as the study progressed (adjusted O.R = 74.1, 95% CI = 21.11-260.1, p<0.001). The changes in the ""knowledge related to behaviour"" (p = 0.01) and in the ""behaviour related to reporting"" (p<0.001) score was significantly higher in the intervention group. Specialist physicians and nurses (p<0.001), fulfilling additional positions (p<0.001) and those working in other places (p = 0.05) demonstrated a high rate of report. Lectures were preferable as a method to encourage ADRs reporting. The most convenient reporting tools were telephone and online reporting. Thus, implementation and maintenance of a continuous intervention program, by a pharmacovigilance specialist staff member, will improve ADRs reporting rates.",2020,"The changes in the ""knowledge related to behaviour"" (p = 0.01) and in the ""behaviour related to reporting"" (p<0.001) score was significantly higher in the intervention group.",['medical professionals (physicians and nurses'],"['posters, lectures, distant electronic learning and reminders']","['Adverse drug reactions (ADRs', 'number of ADRs reports']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.0325042,"The changes in the ""knowledge related to behaviour"" (p = 0.01) and in the ""behaviour related to reporting"" (p<0.001) score was significantly higher in the intervention group.","[{'ForeName': 'Miri', 'Initials': 'M', 'LastName': 'Potlog Shchory', 'Affiliation': 'Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Lee H', 'Initials': 'LH', 'LastName': 'Goldstein', 'Affiliation': 'Clinical Pharmacology Unit, Haemek Medical Center, Afula affiliated to The Bruce Rapapport School of Medicine, Technion, Haifa, Israel.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Arcavi', 'Affiliation': 'Clinical Pharmacology Unit, Kaplan Medical Center, Hebrew University and Hadassah Medical School, Rehovot, Jerusalem, Israel.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Shihmanter', 'Affiliation': 'Clinical Pharmacology Unit, Kaplan Medical Center, Hebrew University and Hadassah Medical School, Rehovot, Jerusalem, Israel.'}, {'ForeName': 'Matitiahu', 'Initials': 'M', 'LastName': 'Berkovitch', 'Affiliation': 'Clinical Pharmacology Unit, Shamir Medical Center (Assaf Harofeh), Zerifin, Affiliated to Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.'}, {'ForeName': 'Amalia', 'Initials': 'A', 'LastName': 'Levy', 'Affiliation': 'Department of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel.'}]",PloS one,['10.1371/journal.pone.0235591']
2051,32790699,Replicating and extending the effects of auditory religious cues on dishonest behavior.,"Although scientists agree that replications are critical to the debate on the validity of religious priming research, religious priming replications are scarce. This paper attempts to replicate and extend previously observed effects of religious priming on ethical behavior. We test the effect of religious instrumental music on individuals' ethical behavior with university participants (N = 408) in the Czech Republic, Japan, and the US. Participants were randomly assigned to listen to one of three musical tracks (religious, secular, or white noise) or to no music (control) for the duration of a decision-making game. Participants were asked to indicate which side of a vertically-bisected computer screen contained more dots and, in every trial, indicating that the right side of the screen had more dots earned participants the most money (irrespective of the number of dots). Therefore, participants were able to report dishonestly to earn more money. In agreement with previous research, we did not observe any main effects of condition. However, we were unable to replicate a moderating effect of self-reported religiosity on the effects of religious music on ethical behavior. Nevertheless, further analyses revealed moderating effects for ritual participation and declared religious affiliation congruent with the musical prime. That is, participants affiliated with a religious organization and taking part in rituals cheated significantly less than their peers when listening to religious music. We also observed significant differences in cheating behavior across samples. On average, US participants cheated the most and Czech participants cheated the least. We conclude that normative conduct is, in part, learned through active membership in religious communities and our findings provide further support for religious music as a subtle, moral cue.",2020,"On average, US participants cheated the most and Czech participants cheated the least.","[""individuals' ethical behavior with university participants (N = 408) in the Czech Republic, Japan, and the US""]","['religious instrumental music', 'musical tracks (religious, secular, or white noise) or to no music (control) for the duration of a decision-making game', 'auditory religious cues']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",[],408.0,0.0394338,"On average, US participants cheated the most and Czech participants cheated the least.","[{'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Nichols', 'Affiliation': 'Questrom School of Business, Boston University, Boston, MA, United States of America.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lang', 'Affiliation': 'LEVYNA Laboratory for the Experimental Research of Religion, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Kavanagh', 'Affiliation': 'Institute of Cognitive & Evolutionary Anthropology, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Radek', 'Initials': 'R', 'LastName': 'Kundt', 'Affiliation': 'LEVYNA Laboratory for the Experimental Research of Religion, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Yamada', 'Affiliation': 'Department of Behavioral Science, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Ariely', 'Affiliation': 'Social Sciences Research Institute, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Mitkidis', 'Affiliation': 'Social Sciences Research Institute, Duke University, Durham, NC, United States of America.'}]",PloS one,['10.1371/journal.pone.0237007']
2052,32790783,Observed feeding behaviours and effects on child weight and length at 12 months of age: Findings from the SPRING cluster-randomized controlled trial in rural India.,"BACKGROUND


Child undernutrition results in poor growth in early childhood, undermines optimal development and increases the risk of mortality. Responsive feeding has been promoted as a key intervention for improving nutritional status, however measurement of this remains difficult and has rarely considered child behaviour. We therefore developed a new observed feeding tool to assess both child and caregiver behaviours, as well as their interaction during feeding, and investigate the effect of these on children anthropometric measures at 12-months of age in rural India.
METHODS


Our study was nested within the SPRING cluster-randomized controlled trial in Rewari, North India. Outcomes were children length-for-age (LAZ), weight-for-length (WLZ) and weight-for-age (WAZ) Z scores at 12 months of age, based on the WHO Child Growth standards. Trained non-specialists live-coded feeding episodes using the newly designed tool. Scores were then created using principal components analysis representing child behaviour, caregiver behaviour and caregiver-child interaction. Mixed effects linear regression was used to assess associations between feeding behaviours and anthropometric outcomes.
RESULTS


857 children had a meal observation and were included. Anthropometric status was poor (mean length-for-age -1.59 (SD = 1.11); mean weight-for-length -0.58 (0.95); mean weight-for-age -1.22 (1.04)). There were positive linear differences in weight-for-length per unit increase in caregiver responsive behaviours score (adjusted β-coeff = 0.006, 95%CI = (0.001, 0.011), p = 0.01), in length-for-age and weight-for-age per unit increase in child responsive behaviours score (respectively adjusted β-coeff = 0.004, 95%CI = (0.001, 0.007), p = 0.02, and adjusted β-coeff = 0.003, 95%CI = (0.00001, 0.006), p = 0.049), and in both weight-for-length and weight-for-age per unit increase in caregiver-child interaction score (respectively adjusted β-coeff = 0.007, 95%CI = (0.003, 0.012), p = 0.001, and adjusted β-coeff = 0.005, 95%CI = (0.001, 0.011), p = 0.01). No association was seen between child behaviours and weight-for-length, caregiver behaviours and length and caregiver-child interaction and length.
CONCLUSIONS


We found that trained non-specialists could assess feeding episodes using a newly designed checklist. Further, child and caregiver behaviours were associated with weight and length at only 12 months of age, a reminder of the importance of interventions to improve responsive feeding quality as we strive towards achievement of the sustainable development goals.",2020,"No association was seen between child behaviours and weight-for-length, caregiver behaviours and length and caregiver-child interaction and length.
",['857 children had a meal observation and were included'],[],"['children length-for-age (LAZ), weight-for-length (WLZ) and weight-for-age (WAZ) Z scores', 'mean weight', 'Anthropometric status', 'child behaviours and weight-for-length, caregiver behaviours and length and caregiver-child interaction and length', 'child responsive behaviours score', 'weight-for-length per unit increase in caregiver responsive behaviours score', 'child weight and length', 'weight-for-length and weight-for-age per unit increase in caregiver-child interaction score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1321223', 'cui_str': 'Caregiver behavior'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",857.0,0.11637,"No association was seen between child behaviours and weight-for-length, caregiver behaviours and length and caregiver-child interaction and length.
","[{'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Boucheron', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Bhopal', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Deepali', 'Initials': 'D', 'LastName': 'Verma', 'Affiliation': 'Child Development Group, Sangath, New Delhi, India.'}, {'ForeName': 'Reetabrata', 'Initials': 'R', 'LastName': 'Roy', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Kumar', 'Affiliation': 'Child Development Group, Sangath, New Delhi, India.'}, {'ForeName': 'Gauri', 'Initials': 'G', 'LastName': 'Divan', 'Affiliation': 'Child Development Group, Sangath, New Delhi, India.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Kirkwood', 'Affiliation': 'Maternal & Child Health Intervention Research Group, Department of Population Health, Faculty of Epidemiology & Population Health, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0237226']
2053,32790788,"RE-PERG in early-onset Alzheimer's disease: A double-blind, electrophysiological pilot study.","PURPOSE


To evaluate the ability of re-test pattern electroretinogram (RE-PERG), a non-invasive and fast steady-state PERG, to detect inner retinal bioelectric function anomalies in patients with early-onset Alzheimer's disease (AD).
METHODS


The study population consisted of 17 patients with AD-related mild cognitive impairment (MCI), 16 patients with vascular dementia (VD)-related MCI, both assessed using the neuropsychological Mini-Mental State Examination (MMSE) and by structural magnetic resonance imaging, and 19 healthy, age-matched normal controls (NC). All participants were visually asymptomatic, had normal or near-normal general cognitive functioning and no or minimal impairments in daily life activities. Visual field (VF) test, optical coherence tomography (OCT) and RE-PERG, sampled in five consecutive blocks of 130 events, were performed.
RESULTS


There was no statistically significant difference among the three groups with respect to age, VF parameters (mean and pattern standard deviations) and OCT parameters (ganglion cell complex thickness and retinal nerve fiber layer thickness). The mean amplitude in the RE-PERG was significantly lower, but only weakly in the AD group than in NC (p = 0.1) whereas the intrinsic variability of the 2nd harmonic phase was significantly higher in the AD group than in either the VD or NC group (p<0.001).
CONCLUSIONS


RE-PERG is altered in early-stage AD, showing a reduced amplitude with high intrinsic phase variability. It also allows the discrimination of AD from VD. A high intrinsic variability in the PERG signal, determined using RE-PERG, may thus be a new promising test for neurodegenerative diseases.",2020,"The mean amplitude in the RE-PERG was significantly lower, but only weakly in the AD group than in NC (p = 0.1) whereas the intrinsic variability of the 2nd harmonic phase was significantly higher in the AD group than in either the VD or NC group (p<0.001).
","['All participants were visually asymptomatic, had normal or near-normal general cognitive functioning and no or minimal impairments in daily life activities', '17 patients with AD-related mild cognitive impairment (MCI), 16 patients with vascular dementia (VD)-related MCI, both assessed using the neuropsychological Mini-Mental State Examination (MMSE) and by structural magnetic resonance imaging, and 19 healthy, age-matched normal controls (NC', 'five consecutive blocks of 130 events, were performed', ""patients with early-onset Alzheimer's disease (AD"", ""early-onset Alzheimer's disease""]","['RE-PERG', 're-test pattern electroretinogram (RE-PERG']","['Visual field (VF) test, optical coherence tomography (OCT) and RE-PERG', 'OCT parameters (ganglion cell complex thickness and retinal nerve fiber layer thickness', 'mean amplitude in the RE-PERG', 'intrinsic variability of the 2nd harmonic phase']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0011269', 'cui_str': 'Vascular dementia'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0750901', 'cui_str': 'Primary degenerative dementia of the Alzheimer type, presenile onset'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}]","[{'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0035316', 'cui_str': 'Retinal Ganglion Cells'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",17.0,0.0540823,"The mean amplitude in the RE-PERG was significantly lower, but only weakly in the AD group than in NC (p = 0.1) whereas the intrinsic variability of the 2nd harmonic phase was significantly higher in the AD group than in either the VD or NC group (p<0.001).
","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Mavilio', 'Affiliation': 'Social Health District, Glaucoma Center, Azienda Sanitaria Locale-Brindisi, Brindisi, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Sisto', 'Affiliation': 'Department of Neurosciences, Institute of Ophthalmology, University of Bari, Bari, Italy.'}, {'ForeName': 'Florenza', 'Initials': 'F', 'LastName': 'Prete', 'Affiliation': 'Social Health District, Alzheimer Evaluation Units, Azienda Sanitaria Locale-Brindisi, Brindisi, Italy.'}, {'ForeName': 'Viviana', 'Initials': 'V', 'LastName': 'Guadalupi', 'Affiliation': 'Social Health District, Alzheimer Evaluation Units, Azienda Sanitaria Locale-Brindisi, Brindisi, Italy.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': 'Dammacco', 'Affiliation': 'Department of Neurosciences, Institute of Ophthalmology, University of Bari, Bari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Alessio', 'Affiliation': 'Department of Neurosciences, Institute of Ophthalmology, University of Bari, Bari, Italy.'}]",PloS one,['10.1371/journal.pone.0236568']
2054,32790789,Identification and treatment of obstructive sleep apnea by a primary care team with a subset focus on chronic pain management.,"BACKGROUND


Patients diagnosed with obstructive sleep apnea (OSA), who also consume prescription opioids, have a greater likelihood of morbidity and mortality. This study evaluated whether a primary care team, focused on chronic pain care management, could use a validated questionnaire (STOP-Bang) and motivational follow-up, to increase identification and treatment of OSA.
METHODS


This study was a retrospective, dual arm, pre/post controlled study. Participants of this study included the complete chronic pain management sub group treated by this primary care team. Participants were ≥ 18 years old and prescribed daily opioids for treatment of chronic pain. All participants had a multifaceted, individualized, educational meeting that included completing a STOP-Bang questionnaire. Participants who received a score ≥ three were advised to follow up with their primary care physician. Participants were seen quarterly throughout the study.
RESULTS


The primary outcome of this study was that 65% of participants with likely OSA were using CPAP for a minimum of 12 months (range of 12-25 months, 18-month average) post-intervention vs. 37% CPAP-use in the control group (12 months of observation), both groups were chronic opioid users with OSA. This was a 28% relative improvement (p = 0.0034). A secondary outcome was that 8.9% of non-prior CPAP users obtained CPAP post- intervention; a 56.7% pre-post improvement (p = 0.0064, x2 = 10.08 with 1 degree of freedom). Also, participants who were likely to have OSA (STOP-Bang score ≥ 3 or had a positive polysomnography (AHI >5 with comorbidities)) compared to those unlikely to have OSA (STOP-Bang score <3 or had a negative polysomnography (AHI <5)) in this study were more likely to be male, have a higher BMI, have hypertension, have cardiovascular disease and/or have diabetes (all types).
CONCLUSION


Team based care management for participants taking prescription opioids, where STOP-Bang questionnaires were completed, were associated with an increase in the identification and treatment of OSA.",2020,This was a 28% relative improvement (p = 0.0034).,"['All participants had a multifaceted, individualized, educational meeting that included completing a STOP-Bang questionnaire', 'Patients diagnosed with obstructive sleep apnea (OSA', 'Participants were ≥ 18 years old and prescribed daily opioids for treatment of chronic pain', 'participants who were likely to have OSA (STOP-Bang score ≥ 3 or had a positive polysomnography', 'Participants who received a score ≥ three were advised to follow up with their primary care physician']","['CPAP', 'negative polysomnography']","['obstructive sleep apnea', 'likely OSA']","[{'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0302363', 'cui_str': 'Infection due to Brucella abortus'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C1828381', 'cui_str': 'Recommendation - action'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]",,0.0590701,This was a 28% relative improvement (p = 0.0034).,"[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Whittington', 'Affiliation': 'Internal Medicine, Intermountain Healthcare, Sandy, Utah, United States of America.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'Simpson', 'Affiliation': 'Intermountain Healthcare, Sandy, Utah, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Clay', 'Affiliation': 'Pulmonary and Sleep Medicine, Intermountain Healthcare, Sandy, Utah, United States of America.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Tierney', 'Affiliation': 'Intermountain Healthcare, Sandy, Utah, United States of America.'}, {'ForeName': 'Dixie', 'Initials': 'D', 'LastName': 'Harris', 'Affiliation': 'Pulmonary and Sleep Medicine, Intermountain Healthcare, Sandy, Utah, United States of America.'}]",PloS one,['10.1371/journal.pone.0237359']
2055,32790792,Caffeine increases motor output entropy and performance in 4 km cycling time trial.,"Caffeine improves cycling time trial performance through enhanced motor output and muscle recruitment. However, it is unknown if caffeine further increases power output entropy. To investigate the effects of caffeine effects on cycling time trial performance and motor output entropy (MOEn), nine cyclists (VO2MAX of 55 ± 6.1 mL.kg.-1min-1) performed a 4 km cycling time trial (TT4km) after caffeine and placebo ingestion in a counterbalanced order. Power output data were sampled at a 2 Hz frequency, thereafter entropy was estimated on a sliding-window fashion to generate a power output time series. A number of mixed models compared performance and motor output entropy between caffeine and placebo every 25% of the total TT4km distance. Caffeine ingestion improved power output by 8% (p = 0.003) and increased MOEn by 7% (p = 0.018). Cyclists adopted a U-shaped pacing strategy after caffeine ingestion. MOEn mirrored power output responses as an inverted U-shape MOEn during the time trial. Accordingly, a strong inverse correlation was observed between MOEn and power output responses over the last 25% of the TT4km (p < 0.001), regardless of the ingestion, likely reflecting the end spurt during this period (p = 0.016). Caffeine ingestion improved TT4km performance and motor output responses likely due to a greater power output entropy.",2020,Caffeine ingestion improved power output by 8% (p = 0.003) and increased MOEn by 7% (p = 0.018).,['nine cyclists (VO2MAX of 55 ± 6.1 mL.kg.-1min-1'],"['caffeine and placebo', 'caffeine', 'Caffeine', 'caffeine and placebo ingestion', 'Caffeine ingestion']","['TT4km performance and motor output responses', 'cycling time trial performance and motor output entropy (MOEn', 'MOEn', 'MOEn and power output responses', 'power output']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0445194', 'cui_str': 'Power output'}]",,0.256056,Caffeine ingestion improved power output by 8% (p = 0.003) and increased MOEn by 7% (p = 0.018).,"[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Ferreira Viana', 'Affiliation': 'Physical Education course, Augusto Motta University Center (UNISUAM), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Gabriel S', 'Initials': 'GS', 'LastName': 'Trajano', 'Affiliation': 'School of Exercise and Nutrition Sciences, Queensland University of Technology, Kelvin Grove, QLD, Australia.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ugrinowitsch', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, SP, Brazil.'}, {'ForeName': 'Flávio', 'Initials': 'F', 'LastName': 'Oliveira Pires', 'Affiliation': 'Exercise Psychophysiology Research Group, School of Arts, Sciences and Humanities, University of São Paulo, SP, Brazil.'}]",PloS one,['10.1371/journal.pone.0236592']
2056,32791665,"Randomized, double-blind, placebo-controlled, parallel-group trial of sirolimus for tocilizumab-resistant idiopathic multicentric Castleman disease: Study protocol for clinical trial.","BACKGROUND


Idiopathic multicentric Castleman disease (iMCD) is a rare lymphoproliferative disorder of unknown etiology with systemic symptoms that include fever, night sweats, weight loss, and fatigue. Although tocilizumab (TCZ), which is a recombinant, humanized, anti-human interleukin 6 receptor monoclonal antibody, has been recommended to treat patients with iMCD, 40% of patients with iMCD do not achieve complete remission with TCZ treatment.
METHODS/DESIGN


In this phase II, investigator-initiated, multicenter, double-blind, randomized, parallel-group trial, the efficacy and safety of sirolimus will be compared with placebo in patients with TCZ-resistant iMCD. The study will be conducted in 8 centers in Japan. Participants (n = 20) will be randomly assigned to receive 2 mg of oral sirolimus (n = 10) or placebo (n = 10) once daily for 16 weeks. The primary endpoint is a decrease in CHAP score by ≥1 from baseline at 16 weeks. Secondary endpoints include levels of hemoglobin, albumin, and C-reactive protein; change in CHAP score; SF-36 Health Survey Questionnaire; physician global assessment (100 mm visual analog scale); patient global assessment (100 mm visual analog scale) at 2, 4, 8, 12, and 16 weeks; change in lymphadenopathy at 16 weeks; and pharmacodynamic assessment, including the measurement of whole blood sirolimus level.
DISCUSSION


This clinical trial will provide evidence of efficacy and safety of sirolimus as a potential new therapeutic agent for patients with TCZ-resistant iMCD.
TRIAL REGISTRATION


This study was registered with the Japan Registry of Clinical Trials as jRCT2071190029 on October 8, 2019.",2020,"Secondary endpoints include levels of hemoglobin, albumin, and C-reactive protein; change in CHAP score; SF-36 Health Survey Questionnaire; physician global assessment (100 mm visual analog scale); patient global assessment (100 mm visual analog scale) at 2, 4, 8, 12, and 16 weeks; change in lymphadenopathy at 16 weeks; and pharmacodynamic assessment, including the measurement of whole blood sirolimus level.
","['Participants (n\u200a=\u200a20', 'patients with TCZ-resistant iMCD', '8 centers in Japan', 'resistant idiopathic multicentric Castleman disease']","['sirolimus', 'tocilizumab', 'oral sirolimus', 'tocilizumab (TCZ', 'placebo']","['lymphadenopathy at 16 weeks; and pharmacodynamic assessment, including the measurement of whole blood sirolimus level', 'efficacy and safety', 'levels of hemoglobin, albumin, and C-reactive protein; change in CHAP score; SF-36 Health Survey Questionnaire; physician global assessment (100\u200amm visual analog scale); patient global assessment (100\u200amm visual analog scale', 'CHAP score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C5197665', 'cui_str': 'HHV-8-negative idiopathic multicentric Castleman disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0497156', 'cui_str': 'Lymphadenopathy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C1618097', 'cui_str': 'Measurement of sirolimus'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0950540', 'cui_str': 'CHAP protocol'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",,0.742216,"Secondary endpoints include levels of hemoglobin, albumin, and C-reactive protein; change in CHAP score; SF-36 Health Survey Questionnaire; physician global assessment (100 mm visual analog scale); patient global assessment (100 mm visual analog scale) at 2, 4, 8, 12, and 16 weeks; change in lymphadenopathy at 16 weeks; and pharmacodynamic assessment, including the measurement of whole blood sirolimus level.
","[{'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Koga', 'Affiliation': 'aDepartment of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences bCenter for Bioinformatics and Molecular Medicine, Nagasaki University Graduate School of Biomedical Sciences cNagasaki University Hospital, Clinical Research Center, Nagasaki, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Hagimori', 'Affiliation': ''}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Takemori', 'Affiliation': ''}, {'ForeName': 'Shimpei', 'Initials': 'S', 'LastName': 'Morimoto', 'Affiliation': ''}, {'ForeName': 'Remi', 'Initials': 'R', 'LastName': 'Sumiyoshi', 'Affiliation': ''}, {'ForeName': 'Toshimasa', 'Initials': 'T', 'LastName': 'Shimizu', 'Affiliation': ''}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Hosogaya', 'Affiliation': ''}, {'ForeName': 'Chizu', 'Initials': 'C', 'LastName': 'Fukushima', 'Affiliation': ''}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yamamoto', 'Affiliation': ''}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kawakami', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020710']
2057,32791671,"Effects and safety of intranasal phototherapy for allergic rhinitis: Study protocol for a single-center, randomized, double-blind, parallel, placebo-controlled, investigator-initiated, pilot study.","INTRODUCTION


Allergic rhinitis (AR) is an immunoglobulin E (Ig E)-mediated inflammatory disease. Intranasal phototherapy is a promising treatment modality because it has a profound immunosuppressive effect, but the available evidence of its use for AR is insufficient. Therefore, rigorously designed randomized controlled trials (RCTs) are needed. Our objective is to describe the protocol for a feasibility trial to assess the effects and safety of intranasal phototherapy for the treatment of AR.
METHODS AND ANALYSIS


This is a study protocol for a single-center, randomized, double-blind, parallel, placebo-controlled, investigator-initiated pilot study. A total of 40 patients with AR will be randomly assigned to the medical device or sham device group in a 1:1 ratio. The participants will receive intranasal phototherapy with a medical or sham device for 20 min 5 times a week for 2 weeks. The primary outcome will be the mean change in the Total Nasal Symptom Score (TNSS) from baseline to 2 weeks. The secondary outcomes will include the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, Nasal Endoscopy Index, total serum Ig E level, and eosinophil count.
DISCUSSION


The findings of this study will provide the basis for subsequent large-scale definitive RCTs to confirm the effects and safety of intranasal phototherapy for the treatment of nasal symptoms in patients with AR who do not respond well to conventional therapy. This study may assist in the development of noninvasive treatment for patients with AR.
TRIAL REGISTRATION


This study was registered at the Korean National Clinical Trial Registry, Clinical Research Information Service (KCT0003253).",2020,The primary outcome will be the mean change in the Total Nasal Symptom Score (TNSS) from baseline to 2 weeks.,"['allergic rhinitis', 'patients with AR', '40 patients with AR', 'patients with AR who do not respond well to conventional therapy']","['intranasal phototherapy', 'Intranasal phototherapy', 'placebo']","['mean change in the Total Nasal Symptom Score (TNSS', 'Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, Nasal Endoscopy Index, total serum Ig E level, and eosinophil count']","[{'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C5190490', 'cui_str': 'Intranasal phototherapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0231918', 'cui_str': 'Nose symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0189024', 'cui_str': 'Endoscopy of nose'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0856520', 'cui_str': 'Serum immunoglobulin E'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}]",40.0,0.5121,The primary outcome will be the mean change in the Total Nasal Symptom Score (TNSS) from baseline to 2 weeks.,"[{'ForeName': 'Jeongin', 'Initials': 'J', 'LastName': 'Kang', 'Affiliation': 'aDepartment of Ophthalmology, Otolaryngology, and Dermatology, College of Korean Medicine, Woo-Suk University, Jeonju bDepartment of Oriental Rehabilitation, National Rehabilitation Center, Seoul cEvidence-Based Healthcare Research Collaborating Center, Woo-Suk University, Jeonju dFuture Medicine Division, Korea Institute of Oriental Medicine eDepartment of Preventive Medicine, College of Korean Medicine, Daejeon University, Daejeon, Korea.'}, {'ForeName': 'Goeun', 'Initials': 'G', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Jeonghun', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Youngeun', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Sunju', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Donghyo', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020835']
2058,32791677,The effect of a video-guided educational technology intervention on the academic self-concept of adolescent students with hearing impairment: Implications for physical education.,"BACKGROUND/OBJECTIVE


Academic self-concept is an important construct within the disciplines of medicine, psychology, and education. Enhancing the academic self-concept of students with special educational needs is very crucial because it is associated with their quality of life. This study aimed to examine the effect of a video-guided educational technology intervention on the academic self-concept of adolescents with hearing impairment who were attending inclusive nonresidential public schools in Southeast Nigeria.
METHODS


This study adopted a randomized controlled trial design. The participants were 60 junior secondary students with hearing impairment. We implemented a video-guided educational technology intervention. It relied on the use of 13-minute video clips with captions/subtitles, which covered academic self-concept-related themes. The Academic Self-Concept Questionnaire, which has been developed by Liu and Wang, was used to collect baseline, posttreatment, and follow-up data. We conducted independent-samples and paired t test and computed Cohen d and Glass Δ to analyze the data.
RESULTS


The video-guided educational technology intervention significantly improved the academic self-concept of the treatment group participants, when compared with the care-as-usual control group participants, t(58) = 9.07, P < .001. These improvements in academic self-concept were sustained at follow up among the treatment group participants, when compared with the care-as-usual control group participants, t(48.56) = 10.898, P < .001. Within-subjects comparisons showed that the academic self-concept of the treatment group participants had significantly improved across the different time points at which they were assessed.
CONCLUSION


The video-guided educational technology intervention was effective in improving the academic self-concept of adolescents with hearing impairment who were attending inclusive nonresidential public schools. Large-scale studies are needed to maximize the impact of video-guided educational technology interventions on students with hearing impairments who attend inclusive non residential public schools in Nigeria.",2020,"These improvements in academic self-concept were sustained at follow up among the treatment group participants, when compared with the care-as-usual control group participants, t(48.56) = 10.898, P < .001.","['participants were 60 junior secondary students with hearing impairment', 'adolescents with hearing impairment who were attending inclusive nonresidential public schools', 'students with hearing impairments who attend inclusive non residential public schools in Nigeria', 'adolescent students with hearing impairment', 'adolescents with hearing impairment who were attending inclusive nonresidential public schools in Southeast Nigeria']","['video-guided educational technology interventions', 'video-guided educational technology intervention']",['academic self-concept'],"[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0282570', 'cui_str': 'Technology, Educational'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036594', 'cui_str': 'Self Concept'}]",60.0,0.0292084,"These improvements in academic self-concept were sustained at follow up among the treatment group participants, when compared with the care-as-usual control group participants, t(48.56) = 10.898, P < .001.","[{'ForeName': 'Uche D', 'Initials': 'UD', 'LastName': 'Asogwa', 'Affiliation': 'aDepartment of Arts Education bDepartment of Educational Foundations cDepartment of Human Kinetics and Health Education dDepartment of Political Science, Alex Ekwueme Federal University Ndufu-Alike Ikwo, Ebonyi State eDepartment of Computer and Robotics Education, University of Nigeria, Nsukka, Enugu State, Nigeria.'}, {'ForeName': 'Theresa O', 'Initials': 'TO', 'LastName': 'Ofoegbu', 'Affiliation': ''}, {'ForeName': 'Chiedu', 'Initials': 'C', 'LastName': 'Eseadi', 'Affiliation': ''}, {'ForeName': 'Chimaobi Samuel', 'Initials': 'CS', 'LastName': 'Ogbonna', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eskay', 'Affiliation': ''}, {'ForeName': 'Godfrey C', 'Initials': 'GC', 'LastName': 'Nji', 'Affiliation': ''}, {'ForeName': 'Oliver Rotachukwu', 'Initials': 'OR', 'LastName': 'Ngwoke', 'Affiliation': ''}, {'ForeName': 'Victor Chijioke', 'Initials': 'VC', 'LastName': 'Nwosumba', 'Affiliation': ''}, {'ForeName': 'Benardine Ifeoma', 'Initials': 'BI', 'LastName': 'Onah', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021054']
2059,32795739,"Effects of the Lysulin™ supplementation on pre-diabetes: A randomized double-blind, placebo-controlled clinical trial.","BACKGROUND AND AIMS


Diabetes is a leading cause of morbidity and mortality worldwide. Recent studies have demonstrated that nutraceutical products have beneficial effects in diabetes. Present study aims to investigate whether a product (Lysulin™) containing amino acid lysine, micronutrient zinc and vitamin C will have beneficial effects in pre-diabetes.
METHODS


A randomized, double-blind, placebo-controlled trial was conducted for a period of 6 months. The two parallel groups (1:1) were Lysulin™ (Interventional group-IG) and placebo (control group-CG). Evaluations were done at baseline, 1, 3 and 6 months. Primary outcome was defined as change in glycaemic control measured by HbA1c from baseline. Other outcomes included change in; fasting plasma glucose (FPG), 2-h OGTT plasma glucose and lipid profile from baseline. Three multiple regression analyses were performed, where change in FPG, 2-h OGTT, and HbA1c post intervention from baseline respectively were the continuous dependent variable with other independent variables.
RESULTS


One hundred and ten participants were recruited, 50% (n = 55) were males and mean age (±SD) was 46.7 ± 9.9 years. A significantly higher percentage of participants in CG (25.4%, n = 14) developed diabetes in comparison to IG (7.3%, n = 4) (p = 0.018). FPG, 2-h OGTT and HbA1c significantly reduced in the IG only. Both total cholesterol and LDL cholesterol decreased significantly from baseline only in the IG. In all three regression models the best predictor of respective dependent variable was Lysulin™ treatment.
CONCLUSIONS


Lysulin™ improved glycaemic control, with reduced progression to diabetes, in those with pre-diabetes. Treatment also showed a beneficial reduction in total and LDL cholesterol levels.
TRIAL REGISTRATION


Sri Lanka Clinical Trials Registry, identifier: SLCTR/2018/022 (http://slctr.lk/trials/1290). Registered on 13th July 2018; Study protocol version 2.0 (23rd March 2018).",2020,"A significantly higher percentage of participants in CG (25.4%, n = 14) developed diabetes in comparison to IG (7.3%, n = 4) (p = 0.018).","['One hundred and ten participants were recruited, 50% (n\xa0=\xa055) were males and mean age (±SD) was 46.7\xa0±\xa09.9 years']","['Lysulin™', 'Lysulin™ supplementation', 'product (Lysulin™) containing amino acid lysine, micronutrient zinc and vitamin C', 'placebo']","['change in; fasting plasma glucose (FPG), 2-h OGTT plasma glucose and lipid profile', 'FPG, 2-h OGTT and HbA1c', 'change in glycaemic control', 'pre-diabetes', 'total cholesterol and LDL cholesterol', 'total and LDL cholesterol levels', 'glycaemic control']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0024337', 'cui_str': 'Lysine'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",110.0,0.642793,"A significantly higher percentage of participants in CG (25.4%, n = 14) developed diabetes in comparison to IG (7.3%, n = 4) (p = 0.018).","[{'ForeName': 'Priyanga', 'Initials': 'P', 'LastName': 'Ranasinghe', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka. Electronic address: priyanga@pharm.cmb.ac.lk.'}, {'ForeName': 'Ranil', 'Initials': 'R', 'LastName': 'Jayawardena', 'Affiliation': 'Department of Physiology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka; Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia. Electronic address: ranil7@gmail.com.'}, {'ForeName': 'Lal', 'Initials': 'L', 'LastName': 'Chandrasena', 'Affiliation': 'Nawaloka Hospital Research and Education Foundation (NHREF), Nawaloka Hospitals PLC, Colombo, Sri Lanka. Electronic address: dgm@nawaloka.com.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.07.023']
2060,32795835,Is there a role for insulin-like growth factor inhibition in the treatment of COVID-19-related adult respiratory distress syndrome?,"Adult respiratory distress syndrome (ARDS) is the leading cause of death associated with SARS-CoV-2 infection and COVID-19. IGF-1 has been implicated in ARDS, yet its role in relation to COVID-19-related lung injury has not been investigated. We hypothesize that blockage of the IGF-1 receptor (IGF-1R) mitigates lung injury and decreases the risk of death in patients COVID-19-related ARDS. Patients with fibroproliferative ARDS have been shown to have increased IGF-1 and IGF-1R staining in lung tissue specimens. Rising levels of IGF-1 in bronchioalveolar fluid (BAL) and increased IGF-1 mRNA expression in lung tissues (but declining serum IGF-1 levels) have been found in late stage ARDS compared with early lung injury. Blockage of IGF-1R decreases lung tissue damage and increases survival in bleomycin-induced as well as H1N1 influenza-related lung injury in animal models. Teprotumumab is a monoclonal antibody directed against the IGF-1R that was FDA-approved in 2020 for the treatment of Graves' orbitopathy. In order to determine if teprotumumab may reduce lung injury and death related to ARDS in the setting of COVID-19, preliminary clinical data is needed. IGF-1 levels in serum and BAL fluid must be measured in patients with COVID-19-related ARDS. Histopathology from lung samples from patients with COVID-19-related ARDS must be examined for increased expression of the IGF-1R. Once these are ascertained, and if the data support IGF-1 involvement, a randomized, placebo-controlled phase 2A trial of teprotumumab therapy in the setting of COVID-19-related ARDS and non-COVID-19-related ARDS designed to generate initial data on short-term efficacy, safety, dosing and administration should be performed.",2020,Patients with fibroproliferative ARDS have been shown to have increased IGF-1 and IGF-1R staining in lung tissue specimens.,"['COVID-19-related adult respiratory distress syndrome', 'Patients with fibroproliferative ARDS', 'Adult respiratory distress syndrome (ARDS', 'patients with COVID-19-related ARDS']","['placebo', 'IGF-1']","['IGF-1 levels', 'IGF-1 and IGF-1R staining', 'risk of death', 'expression of the IGF-1R']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}]","[{'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0140080', 'cui_str': 'Insulin-Like-Growth Factor I Receptor'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",,0.132459,Patients with fibroproliferative ARDS have been shown to have increased IGF-1 and IGF-1R staining in lung tissue specimens.,"[{'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Winn', 'Affiliation': 'Department of Ophthalmology, University of California San Francisco, San Francisco, CA, United States; Ophthalmology Section, Surgical Service, San Francisco Veterans Affairs Medical Center, San Francisco, CA, United States. Electronic address: bryan.winn@ucsf.edu.'}]",Medical hypotheses,['10.1016/j.mehy.2020.110167']
2061,32795875,Cost-effectiveness analysis of the 70-gene signature compared with clinical assessment in breast cancer based on a randomised controlled trial.,"BACKGROUND


The clinical utility of the 70-gene signature (MammaPrint®) to guide chemotherapy use in T1-3N0-1M0 breast cancer was demonstrated in the Microarray in Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy (MINDACT) study. One thousand four ninety seven of 3356 (46.2%) enrolled patients with high clinical risk (in accordance with the modified Adjuvant! Online clinical-pathological assessment) had a low-risk 70-gene signature. Using patient-level data from the MINDACT trial, the cost-effectiveness of using the 70-gene signature to guide adjuvant chemotherapy selection for clinical high risk, estrogen receptor positive (ER+), human epidermal growth factor 2 negative (HER2-) patients was analysed.
PATIENTS AND METHODS


A hybrid decision tree-Markov model simulated treatment strategies in accordance with the 70-gene signature with clinical assessment versus clinical assessment alone, over a 10-year time horizon. Primary outcomes were quality-adjusted life years (QALYs), country-specific costs and incremental cost-effectiveness ratios (ICERs) for six countries: Belgium, France, Germany, Netherlands, UK and the US.
RESULTS


Treatment strategies guided by the 70-gene signature result in more QALYs compared with clinical assessment alone. Costs of the 70-gene signature strategy were lower in five of six countries. This led to dominance of the 70-gene signature in Belgium, France, Germany, Netherlands and the US and to a cost-effective situation in the UK (ICER £22,910/QALY). Annual national cost savings were €4.2M (Belgium), €24.7M (France), €45.1M (Germany), €12.7M (Netherlands) and $244M (US). UK budget increase was £8.4M.
CONCLUSION


Using the 70-gene signature to safely guide chemotherapy de-escalation in clinical high risk patients with ER+/HER2- tumours is cost-effective compared with using clinical assessment alone. Long-term follow-up and outcomes from the MINDACT trial are necessary to address uncertainties in model inputs.",2020,"Annual national cost savings were €4.2M (Belgium), €24.7M (France), €45.1M (Germany), €12.7M (Netherlands) and $244M (US).",['One thousand four ninety seven of 3356 (46.2%) enrolled patients with high clinical risk (in accordance with the modified Adjuvant'],[],"['quality-adjusted life years (QALYs), country-specific costs and incremental cost-effectiveness ratios (ICERs) for six countries: Belgium, France, Germany, Netherlands, UK and the US', 'Annual national cost savings']","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]",[],"[{'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}]",,0.0661509,"Annual national cost savings were €4.2M (Belgium), €24.7M (France), €45.1M (Germany), €12.7M (Netherlands) and $244M (US).","[{'ForeName': 'Valesca P', 'Initials': 'VP', 'LastName': 'Retèl', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Health Technology and Services Research Department, Technical Medical Centre, University of Twente, P.O. Box 217, 7500 AE, Enschede, the Netherlands. Electronic address: v.retel@nki.nl.'}, {'ForeName': 'Danalyn', 'Initials': 'D', 'LastName': 'Byng', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Health Technology and Services Research Department, Technical Medical Centre, University of Twente, P.O. Box 217, 7500 AE, Enschede, the Netherlands.'}, {'ForeName': 'Sabine C', 'Initials': 'SC', 'LastName': 'Linn', 'Affiliation': 'Division of Molecular Pathology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Department of Medical Oncology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Department of Pathology, University Medical Centre, Utrecht University, Huispost STR 6.131, P.O. Box 85500, 3508 GA, Utrecht, the Netherlands.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Jóźwiak', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Institute of Biostatistics and Registry Research, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany.'}, {'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Koffijberg', 'Affiliation': 'Health Technology and Services Research Department, Technical Medical Centre, University of Twente, P.O. Box 217, 7500 AE, Enschede, the Netherlands.'}, {'ForeName': 'Emiel J', 'Initials': 'EJ', 'LastName': 'Rutgers', 'Affiliation': 'Department of Surgery, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Cardoso', 'Affiliation': 'Breast Unit, Champalimaud Clinical Center/Champalimaud Foundation, Lisbon, Portugal, Av. De Brasilia, s/n, 1400-048, Lisbon, Portugal.'}, {'ForeName': 'Martine J', 'Initials': 'MJ', 'LastName': 'Piccart', 'Affiliation': 'Breast Cancer Translational Research Laboratory J.-C. Heuson, Institut Jules Bordet, Université Libre de Bruxelles, 121-125, Boulevard de Waterloo, 1000, Brussels, Belgium.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Poncet', 'Affiliation': 'European Organisation for Research and Treatment of Cancer, Avenue Emmanuel Mounier, 83/11, 1200, Brussels, Belgium.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': ""Van't Veer"", 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, 2340 Sutter Street, San Francisco, CA, 94115, USA.'}, {'ForeName': 'Wim H', 'Initials': 'WH', 'LastName': 'van Harten', 'Affiliation': 'Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, the Netherlands; Health Technology and Services Research Department, Technical Medical Centre, University of Twente, P.O. Box 217, 7500 AE, Enschede, the Netherlands.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.07.002']
2062,32795903,Ventilatory support during whole-body row training improves oxygen uptake efficiency in patients with high-level spinal cord injury: A pilot study.,"High-level spinal cord injury (SCI) is characterized by profound respiratory compromise. One consequence is a limitation of whole-body exercise-based rehabilitation, reducing its cardioprotective effect. We investigated the use of ventilatory support during training on cardiorespiratory response to exercise. Nine subjects with high-level SCI (T3-C4) were included in this double-blind sham-controlled study. All had training adaptations plateauing for more than 6 months before enrolling in the study. After performing baseline assessment, participants were randomly assigned to continue training with non-invasive ventilation (NIV: n = 6: IPAP = 20 ± 2, EPAP: 3 cmH 2 O) or sham (n = 3: IPAP = 5, EPAP: 3 cmH 2 O) for 3 months and performed again maximal exercise tests. We compared the oxygen uptake efficiency slope (OUES, the rate of increases in VO 2  in relation to increasing VE) before and after training. Training with NIV increased OUES both compared to baseline (4.1 ± 1.1 vs. 3.4 ± 1.0, i.e. +20 ± 12%, p < 0.05) and Sham (p = 0.01), representing an increase in ability to uptake oxygen for a given ventilation. This result was sustained without NIV during the test, suggesting improved cardiopulmonary reserve. Best responders were the youngest whose characteristics were very similar to sham participants. In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham). Our results are very suggestive of a positive effect of ventilatory support during whole-body exercise in high-level SCI. Training adaptations found are of great importance since this sub-population of patients have the greatest need for exercise-based cardio-protection.",2020,"In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham).","['Nine subjects with high-level SCI (T3-C4', 'patients with high-level spinal cord injury']","['continue training with non-invasive ventilation (NIV: n\xa0=\xa06: IPAP\xa0=\xa020\xa0±\xa02, EPAP: 3 cmH 2 O) or sham (n\xa0=\xa03: IPAP\xa0=\xa05, EPAP: 3 cmH 2 O) for 3 months and performed again maximal exercise tests', 'Ventilatory support during whole-body row training']","['oxygen uptake efficiency', 'weekly rowing distance', 'ability to uptake oxygen', 'oxygen uptake efficiency slope (OUES']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",9.0,0.0857854,"In addition, NIV tended to increase weekly rowing distance by 24% (p = 0.09, versus 10% in sham).","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Vivodtzev', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA; Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, 75013, Paris, France. Electronic address: isabelle.vivodtzev@sorbonne.universite.fr.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Napolitano', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Picard', 'Affiliation': 'Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Harvard Medical School, Department of Physical Medicine and Rehabilitation, Boston, MA, USA; Spaulding Rehabilitation Hospital, Cardiovascular Research Laboratory, Cambridge, MA, USA.'}]",Respiratory medicine,['10.1016/j.rmed.2020.106104']
2063,32796084,Changes in medication administration error rates associated with the introduction of electronic medication systems in hospitals: a multisite controlled before and after study.,"BACKGROUND


Electronic medication systems (EMS) have been highly effective in reducing prescribing errors, but little research has investigated their effects on medication administration errors (MAEs).
OBJECTIVE


To assess changes in MAE rates and types associated with EMS implementation.
METHODS


This was a controlled before and after study (three intervention and three control wards) at two adult teaching hospitals. Intervention wards used an EMS with no bar-coding. Independent, trained observers shadowed nurses and recorded medications administered and compliance with 10 safety procedures. Observational data were compared against medication charts to identify errors (eg, wrong dose). Potential error severity was classified on a 5-point scale, with those scoring ≥3 identified as serious. Changes in MAE rates preintervention and postintervention by study group, accounting for differences at baseline, were calculated.
RESULTS


7451 administrations were observed (4176 pre-EMS and 3275 post-EMS). At baseline, 30.2% of administrations contained ≥1 MAE, with wrong intravenous rate, timing, volume and dose the most frequent. Post-EMS, MAEs decreased on intervention wards relative to control wards by 4.2 errors per 100 administrations (95% CI 0.2 to 8.3; p=0.04). Wrong timing errors alone decreased by 3.4 per 100 administrations (95% CI 0.01 to 6.7; p<0.05). EMS use was associated with an absolute decline in potentially serious MAEs by 2.4% (95% CI 0.8 to 3.9; p=0.003), a 56% reduction in the proportion of potentially serious MAEs. At baseline, 74.1% of administrations were non-compliant with ≥1 of 10 procedures and this rate did not significantly improve post-EMS.
CONCLUSIONS


Implementation of EMS was associated with a modest, but significant, reduction in overall MAE rate, but halved the proportion of MAEs rated as potentially serious.",2020,"Post-EMS, MAEs decreased on intervention wards relative to control wards by 4.2 errors per 100 administrations (95% CI 0.2 to 8.3; p=0.04).",['hospitals'],[],"['proportion of potentially serious MAEs', 'overall MAE rate']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}]",[],"[{'cui': 'C3469597', 'cui_str': 'Administration of medication'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0286540', 'cui_str': 'MAV protocol'}]",7451.0,0.0392163,"Post-EMS, MAEs decreased on intervention wards relative to control wards by 4.2 errors per 100 administrations (95% CI 0.2 to 8.3; p=0.04).","[{'ForeName': 'Johanna I', 'Initials': 'JI', 'LastName': 'Westbrook', 'Affiliation': 'Centre for Health Systems and Safety Research, Macquarie University Australian Institute of Health Innovation, Sydney, New South Wales, Australia johanna.westbrook@mq.edu.au.'}, {'ForeName': 'Neroli S', 'Initials': 'NS', 'LastName': 'Sunderland', 'Affiliation': 'Centre for Health Systems and Safety Research, Macquarie University Australian Institute of Health Innovation, Sydney, New South Wales, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Woods', 'Affiliation': 'Centre for Health Systems and Safety Research, Macquarie University Australian Institute of Health Innovation, Sydney, New South Wales, Australia.'}, {'ForeName': 'Magda Z', 'Initials': 'MZ', 'LastName': 'Raban', 'Affiliation': 'Centre for Health Systems and Safety Research, Macquarie University Australian Institute of Health Innovation, Sydney, New South Wales, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gates', 'Affiliation': 'Centre for Health Systems and Safety Research, Macquarie University Australian Institute of Health Innovation, Sydney, New South Wales, Australia.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Centre for Health Systems and Safety Research, Macquarie University Australian Institute of Health Innovation, Sydney, New South Wales, Australia.'}]",BMJ health & care informatics,['10.1136/bmjhci-2020-100170']
2064,32796255,Effects of Eight Weeks of 16: 8 Time-restricted Eating in Male Middle- and Long-Distance Runners.,"PURPOSE


Eight weeks of time-restricted eating (TRE) in concert with habitual exercise training was investigated for effects on body composition, energy and macronutrient intakes, indices of endurance running performance, and markers of metabolic health in endurance athletes.
METHODS


Male middle and long distance runners (n=23) were randomly assigned to TRE (n=12), or habitual dietary intake (CON; n=11). TRE required participants to consume all of their dietary intake within an 8 h eating window (so-called ""16:8"" TRE), but dietary patterns, food choices, and energy intake were ad libitum during this window. Participants continued their habitual training during the intervention period. Participants completed an incremental exercise test before (PRE) and after (POST) the 8 week intervention for assessment of blood lactate concentrations, running economy and maximal oxygen uptake. Fasted blood samples were analysed for glucose, insulin and triglyceride concentrations. Dietary intake was assessed at PRE, MID (week 4), and POST using a four-day semi-weighed food diary.
RESULTS


Seventeen participants (TRE, n=10; CON, n=7) completed the intervention. Training load did not differ between groups for the duration of the intervention period. TRE resulted in a reduction in body mass (mean difference of -1.92 (95% CI, -3.52 to -0.32) kg, P=0.022). Self-reported daily energy intake was lower in TRE at MID and POST (group*time interaction, P=0.049). No effect of TRE was observed for oxygen consumption, respiratory exchange ratio, running economy, blood lactate concentrations or heart rate during exercise, nor were any effects on glucose, insulin or triglyceride concentrations observed.
CONCLUSION


Eight weeks of 16:8 TRE in middle and long distance runners resulted in a decrease in body mass commensurate with a reduction in daily energy intake, but did not alter indices of endurance running performance or metabolic health.",2020,"No effect of TRE was observed for oxygen consumption, respiratory exchange ratio, running economy, blood lactate concentrations or heart rate during exercise, nor were any effects on glucose, insulin or triglyceride concentrations observed.
","['endurance athletes', 'Seventeen participants (TRE, n=10; CON, n=7) completed the intervention', '16: 8 Time-restricted Eating in Male Middle- and Long-Distance Runners', 'Male middle and long distance runners (n=23']","['time-restricted eating (TRE', 'habitual exercise training', 'TRE', 'incremental exercise test before (PRE', 'habitual dietary intake', 'habitual training']","['body mass', 'glucose, insulin or triglyceride concentrations observed', 'glucose, insulin and triglyceride concentrations', 'endurance running performance or metabolic health', 'oxygen consumption, respiratory exchange ratio, running economy, blood lactate concentrations or heart rate', 'Dietary intake', 'body composition, energy and macronutrient intakes, indices of endurance running performance, and markers of metabolic health', 'blood lactate concentrations, running economy and maximal oxygen uptake', 'Self-reported daily energy intake']","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}]",,0.100897,"No effect of TRE was observed for oxygen consumption, respiratory exchange ratio, running economy, blood lactate concentrations or heart rate during exercise, nor were any effects on glucose, insulin or triglyceride concentrations observed.
","[{'ForeName': 'Aidan J', 'Initials': 'AJ', 'LastName': 'Brady', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Henry M', 'Initials': 'HM', 'LastName': 'Langton', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Mollie', 'Initials': 'M', 'LastName': 'Mulligan', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Egan', 'Affiliation': 'School of Health and Human Performance, Dublin City University, Dublin, Ireland.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002488']
2065,32796259,Comparison of Supervised and Telehealth Delivery of Worksite Exercise for Prevention of Low Back Pain in Firefighters: A Cluster Randomized Trial.,"OBJECTIVE


This study assessed worksite exercise delivered by on-site supervision (supervised) or telehealth to reduce lost work time (LWT) related to low back pain (LBP) in firefighters.
METHODS


A cluster randomized controlled trial assigned 264 career firefighters to supervised (n = 86) or telehealth (n = 95) back and core exercises 2X/week for 12 months, or control (n = 83).
RESULTS


58.0% (153/264) of participants reported LBP and 7.6% (20/264) reported LWT related to LBP (control n = 10, supervised n = 5, telehealth n = 5). Participants in the control group experienced 1.15 times as many hours of LWT as the supervised group, and 5.51 times as many hours of LWT as the telehealth group.
CONCLUSIONS


Worksite exercise, delivered by on-site supervision or telehealth, can reduce LWT related to LBP in career firefighters.",2020,"RESULTS


58.0% (153/264) of participants reported LBP and 7.6% (20/264) reported LWT related to LBP (control n = 10, supervised n = ",['Low Back Pain in Firefighters'],"['Supervised and Telehealth Delivery of Worksite Exercise', '264 career firefighters to supervised (n\u200a=\u200a86) or telehealth (n\u200a=\u200a95) back and core exercises 2X/week for 12 months, or control', 'worksite exercise delivered by on-site supervision (supervised) or telehealth to reduce lost work time (LWT', 'Worksite exercise']",[],"[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0221459', 'cui_str': 'Fire fighter'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",[],264.0,0.0476192,"RESULTS


58.0% (153/264) of participants reported LBP and 7.6% (20/264) reported LWT related to LBP (control n = 10, supervised n = ","[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Mayer', 'Affiliation': 'US Spine & Sport Foundation, San Diego, CA (Mayer, Lane, Johnson), Tampa, FL (Brady), University of South Florida, Tampa, FL (Chen, Lu), Spine Research LLC, Winchester, MA (Dagenais).'}, {'ForeName': 'Charity L', 'Initials': 'CL', 'LastName': 'Lane', 'Affiliation': ''}, {'ForeName': ""O'Dane"", 'Initials': 'O', 'LastName': 'Brady', 'Affiliation': ''}, {'ForeName': 'Henian', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Brittany V B', 'Initials': 'BVB', 'LastName': 'Johnson', 'Affiliation': ''}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Dagenais', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001993']
2066,32796287,"The effect of Fennel seed powder on estradiol levels, menopausal symptoms, and sexual desire in postmenopausal women.","OBJECTIVES


The present study was designed to determine the effect of Fennel seed powder on menopausal symptoms, sexual desire, and serum estradiol levels in postmenopausal women.
METHODS


The present study was conducted on 80 eligible women (45-60 y) who were referred to the Mofatteh Gynecology Clinic in Yasuj, Iran. Participants were randomized into equal intervention and control (control) groups. The intervention and control groups received four capsules of Fennel seed powder (2 gr) and starch-containing capsules (2 gr) daily over 8 weeks, respectively. Menopausal symptoms and sexual desire of the participants were evaluated using both the menopausal Kupperman index and Hurlbert index of sexual desire. The questionnaires were completed at baseline, week 4 and week 8 of the study by the participants. The serum estradiol levels were measured at baseline and also at the end of the study. The Chi-square test, independent t test, and repeated-measures analysis of variance were used to analyze the data.
RESULTS


Menopausal symptoms score significantly decreased from 30.8 ± 6 to 19 ± 5.5 in the intervention group and also from 31.2 ± 6.5 to 26.4 ± 6.2 in the control group (P < 0.05). Treatment with Fennel seed did not significantly enhance the participants sexual desire (P > 0.05). The estradiol levels declined in the intervention (from 60.4 ± 43.4 to 52.6 ± 25.7) and control groups (from 55.1 ± 22.4 to 39.9 ± 26.9). However, this decrease was lower in the intervention group than in the control group. The intergroup differences were not statistically significant (P > 0.05).
CONCLUSIONS


The results of the present study indicated that daily use of Fennel seed significantly improved menopausal symptoms in postmenopausal women over 8 weeks, though its effect on estradiol levels and sexual desire was not significant. Further studies with a larger sample size and longer duration are needed to verify these findings.",2020,"RESULTS


Menopausal symptoms score significantly decreased from 30.8 ± 6 to 19 ± 5.5 in the intervention group and also from 31.2 ± 6.5 to 26.4 ± 6.2 in the control group (P < 0.05).","['postmenopausal women', '80 eligible women (45-60 y) who were referred to the Mofatteh Gynecology Clinic in Yasuj, Iran']","['four capsules of Fennel seed powder (2 gr) and starch-containing capsules', 'Fennel seed powder']","['Menopausal symptoms score', 'estradiol levels', 'estradiol levels, menopausal symptoms, and sexual desire', 'Menopausal symptoms and sexual desire', 'menopausal Kupperman index and Hurlbert index of sexual desire', 'serum estradiol levels', 'participants sexual desire', 'menopausal symptoms, sexual desire, and serum estradiol levels', 'menopausal symptoms', 'estradiol levels and sexual desire']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C3839674', 'cui_str': 'Gynecology clinic'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0453256', 'cui_str': 'Fennel seed preparation'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C0236075', 'cui_str': 'Menopausal symptom'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0337434', 'cui_str': 'Estradiol measurement'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}]",80.0,0.0505872,"RESULTS


Menopausal symptoms score significantly decreased from 30.8 ± 6 to 19 ± 5.5 in the intervention group and also from 31.2 ± 6.5 to 26.4 ± 6.2 in the control group (P < 0.05).","[{'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Ghaffari', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Social Determinants of Health Research Center, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Hosseininik', 'Affiliation': 'School of Nursing, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Ardashir', 'Initials': 'A', 'LastName': 'Afrasiabifar', 'Affiliation': 'Professor of Nursing, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Sadeghi', 'Affiliation': 'Medicinal Plants Research Center, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Amar', 'Initials': 'A', 'LastName': 'Hosseininik', 'Affiliation': 'Petroleum Industry Health Organization, Hospital Gachsaran Oil Industry (Besat), Ministry of Petroleum, Tehran, Iran.'}, {'ForeName': 'Seyedeh Marzieh', 'Initials': 'SM', 'LastName': 'Tabatabaei', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Yasuj University of Medical Sciences, Yasuj, Iran.'}, {'ForeName': 'Nazafarin', 'Initials': 'N', 'LastName': 'Hosseini', 'Affiliation': 'Medicinal Plants Research Center, Yasuj University of Medical Sciences, Yasuj, Iran.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001604']
2067,32796301,Conical Biosilicate Implant for Volume Augmentation in Anophthalmic Sockets.,"The ideal implant for anophthalmic socket reconstruction has yet to be developed. Biosilicate, a highly bioactive glass-ceramic, has been used in the composition of conical implants, which were initially tested in rabbit orbits with excellent results. However, the use of this material and the conical shape of the implants require further study in the human anophthalmic socket. Thus, we propose the use of a new conical implant composed of Biosilicate for orbital volume augmentation in anophthalmic sockets. This prospective, randomized study included 45 patients receiving conical implants composed of either Biosilicate or polymethylmethacrylate (control). Patients were evaluated clinically before and 7, 30, 60, 120, and 180 days after implantation. Systemic evaluations, laboratory tests, and computed tomography of the orbits were performed preoperatively and 180 days postoperatively. Both groups had good outcomes with no significant infectious or inflammatory processes. Only 1 patient, in the Biosilicate group, had early implant extrusion. Laboratory tests were normal in both groups. Computed tomography scans showed that the implants in both groups were well positioned. The new conical implant composed of Biosilicate was successfully used for anophthalmic socket reconstruction. This implant may provide a good alternative to the only conical implant currently available on the market, which is composed of porous polyethylene.",2020,Both groups had good outcomes with no significant infectious or inflammatory processes.,"['Anophthalmic Sockets', '45 patients receiving conical implants composed of either Biosilicate or polymethylmethacrylate (control']",['Conical Biosilicate Implant'],"['Systemic evaluations, laboratory tests, and computed tomography of the orbits']","[{'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C3179298', 'cui_str': 'Biosilicate'}, {'cui': 'C0005533', 'cui_str': 'Polymethyl methacrylate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3179298', 'cui_str': 'Biosilicate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}]",45.0,0.0209182,Both groups had good outcomes with no significant infectious or inflammatory processes.,"[{'ForeName': 'Simone Milani', 'Initials': 'SM', 'LastName': 'Brandão', 'Affiliation': 'Division of Medicine, Federal University of Sao Carlos (UFCar), Sao Carlos, São Paulo, Brazil.'}, {'ForeName': 'Rodolfo Artioli', 'Initials': 'RA', 'LastName': 'Schellini', 'Affiliation': 'Radiology Department of Medical School, State University of Sao Paulo (UNESP), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Peitl', 'Affiliation': 'Materials Engineering Department, Center for Research, Technology and Education in Vitreous Materials (CeRTEV), Federal University of São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Edgar Dutra', 'Initials': 'ED', 'LastName': 'Zanotto', 'Affiliation': 'Materials Engineering Department, Center for Research, Technology and Education in Vitreous Materials (CeRTEV), Federal University of São Carlos, São Paulo, Brazil.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Matayoshi', 'Affiliation': 'Ophthalmology Department of Medical School, University of São Paulo (USP), São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Roberta Lilian Fernandes de Sousa', 'Initials': 'RLFS', 'LastName': 'Meneghim', 'Affiliation': 'Ophthalmology Department of Medical School, State University of Sao Paulo (UNESP), Botucatu, São Paulo, Brazil.'}, {'ForeName': 'Silvana Artioli', 'Initials': 'SA', 'LastName': 'Schellini', 'Affiliation': 'Ophthalmology Department of Medical School, State University of Sao Paulo (UNESP), Botucatu, São Paulo, Brazil.'}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006692']
2068,32798286,Effects of Intravesical Lactobacillus Rhamnosus GGon Urinary Symptom Burden in People with Neurogenic Lower Urinary Tract Dysfunction.,"OBJECTIVE


Test the effectiveness of intravesical Lactobacillus rhamnosus GG (LGG) to reduce the burden of urinary symptoms for individuals with spinal cord injury and disease (SCI/D) with neurogenic lower urinary tract dysfunction (NLUTD) who manage their bladders with intermittent catheterization (IC).
DESIGN


A 3-phase study (6 months each in baseline; intervention; and washout).Participants self-managed following the Self-Management Protocol using Probiotics (SMP-Pro), completing the online Urinary Symptom Questionnaire for Neurogenic Bladder-IC version (USQNB-IC) weekly.
SETTING


Nationwide (US).
PARTICIPANTS


96 adults and 7 children with SCI/D.
INTERVENTIONS


In response to one or both of the SMP-Pro trigger urinary symptoms, ""cloudier"" or ""foul smelling"" urine, subjects self-administered using a clean urinary catheter an LGG+Normal Saline instillate once or twice in a 30-hour period.
MAIN OUTCOME MEASURES


Change in USQNB-IC burden was adjusted individually according to the prior phase for four symptom types. Adjusted changes in burden between the intervention and washout phases were analyzed using one-sample t-tests. Holm correction was applied for the four types of symptoms: A, clinically actionable; B1, bladder function; B2, urine quality; and C, other.
RESULTS


During the intervention phase, participants met SMP-Pro instillation criteria3.83 times on average (range 1 - 20). An average of 5.6 doses of LGG were instilled.For those who instilled at least once, burdens of type A and B2 symptoms were significantly improved at washout (both adjusted p<0.05).
CONCLUSIONS


Self-instilled LGGseemed to improve ""clinically actionable"" (A) and ""urine quality"" (B2) symptom burden. No changes were observed for those who did not instill. This first-in-human clinical trial supports ongoing research of intravesicalLGG, and the SMP-Pro for urinary symptoms. This article is protected by copyright. All rights reserved.",2020,"For those who instilled at least once, burdens of type A and B2 symptoms were significantly improved at washout (both adjusted p<0.05).
","['individuals with spinal cord injury and disease (SCI/D) with neurogenic lower urinary tract dysfunction (NLUTD) who manage their bladders with intermittent catheterization (IC', 'People with Neurogenic Lower Urinary Tract Dysfunction', '96 adults and 7 children with SCI/D', 'Nationwide (US']","['SMP-Pro instillation', 'Intravesical Lactobacillus Rhamnosus GGon Urinary Symptom Burden', 'LGG', 'washout).Participants self-managed following the Self-Management Protocol using Probiotics (SMP-Pro), completing the online Urinary Symptom Questionnaire for Neurogenic Bladder-IC version (USQNB-IC) weekly', 'intravesical Lactobacillus rhamnosus GG (LGG']","['USQNB-IC burden', 'clinically actionable"" (A) and ""urine quality"" (B2) symptom burden', 'burdens of type A and B2 symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0005697', 'cui_str': 'Neurogenic bladder'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",96.0,0.0458341,"For those who instilled at least once, burdens of type A and B2 symptoms were significantly improved at washout (both adjusted p<0.05).
","[{'ForeName': 'Rochelle E', 'Initials': 'RE', 'LastName': 'Tractenberg', 'Affiliation': 'Collaborative for Research on Outcomes and -Metrics.'}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Groah', 'Affiliation': 'Department of Rehabilitation Medicine, Georgetown University Medical Center, Washington, D.C.'}, {'ForeName': 'Jamie K', 'Initials': 'JK', 'LastName': 'Frost', 'Affiliation': 'Collaborative for Research on Outcomes and -Metrics.'}, {'ForeName': 'Amanda K', 'Initials': 'AK', 'LastName': 'Rounds', 'Affiliation': 'MedStar National Rehabilitation Hospital, Washington, DC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Davis', 'Affiliation': 'MedStar National Rehabilitation Hospital, Washington, DC.'}, {'ForeName': 'Inger H', 'Initials': 'IH', 'LastName': 'Ljungberg', 'Affiliation': 'MedStar National Rehabilitation Hospital, Washington, DC.'}, {'ForeName': 'Manon M', 'Initials': 'MM', 'LastName': 'Schladen', 'Affiliation': 'Department of Rehabilitation Medicine, Georgetown University Medical Center, Washington, D.C.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12470']
2069,32798329,Evaluation of a psychoeducational intervention compared with education in people with Parkinson's disease and their informal caregivers: a quasi-experimental study.,"AIM


To evaluate the effects of a psychoeducational intervention compared with an education programme to strengthen quality of life, psychosocial adjustment, and coping in people with Parkinson's disease and their informal caregivers.
DESIGN


A quasi-experimental study was performed with repeated measures at baseline, after the intervention and 6 months post-intervention.
METHODS


The study was carried out at seven primary care centres from 2015-2017. A total of 140 people with Parkinson's and 127 informal caregivers were allocated to the experimental and the control groups. The experimental group received a 9-week psychoeducational intervention, whereas the control group received a 5-week education programme. Repeated measures ANOVA were used to test differences in quality of life, psychosocial adjustment, and coping between the experimental and control groups and over time.
RESULTS


Patients and informal caregivers in both the experimental and control groups showed significantly better psychosocial adjustment at the post-intervention measurement compared with baseline data. We also found significantly greater quality of life in patients and coping skills in caregivers after the end of the interventions in the experimental and control groups. Nevertheless, no significant differences were identified on the outcomes at the 6-month post-intervention measurement.
CONCLUSION


The effect of the psychoeducational intervention was not different from the effect of the education programme. The strategies applied in both interventions followed a group approach led by a multidisciplinary team covering information about PD, healthy lifestyles, and social resources. They might be easily sustained in Primary Care to improve care for people with Parkinson's and informal caregivers.",2020,"RESULTS


Patients and informal caregivers in both the experimental and control groups showed significantly better psychosocial adjustment at the post-intervention measurement compared with baseline data.","[""people with Parkinson's disease and their informal caregivers"", ""people with Parkinson's and informal caregivers"", ""140 people with Parkinson's and 127 informal caregivers"", 'seven primary care centres from 2015-2017']","['control group received a 5-week education programme', '9-week psychoeducational intervention', 'psychoeducational intervention', 'education programme']","['quality of life', 'psychosocial adjustment', 'quality of life, psychosocial adjustment, and coping']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",140.0,0.0206952,"RESULTS


Patients and informal caregivers in both the experimental and control groups showed significantly better psychosocial adjustment at the post-intervention measurement compared with baseline data.","[{'ForeName': 'María Victoria', 'Initials': 'MV', 'LastName': 'Navarta-Sánchez', 'Affiliation': 'Department of Nursing, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.'}, {'ForeName': 'Leire', 'Initials': 'L', 'LastName': 'Ambrosio', 'Affiliation': 'Faculty of Nursing, University of Navarre, Pamplona, Navarre, Spain.'}, {'ForeName': 'Mari Carmen', 'Initials': 'MC', 'LastName': 'Portillo', 'Affiliation': 'Faculty of Health Sciences, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Maria Eugenia', 'Initials': 'ME', 'LastName': 'Ursúa', 'Affiliation': 'Primary Health Care Center of San Juan, Navarre Health Service, Pamplona, Navarre, Spain.'}, {'ForeName': 'Juana M', 'Initials': 'JM', 'LastName': 'Senosiain', 'Affiliation': 'Faculty of Nursing, University of Navarre, Pamplona, Navarre, Spain.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Riverol', 'Affiliation': 'Department of Neurology, University of Navarra Clinic, Pamplona, Navarre, Spain.'}]",Journal of advanced nursing,['10.1111/jan.14476']
2070,32797776,Comparative Efficacy of Histrelin Acetate and hCG for Inducing Ovulation in Brazilian Northeastern Jennies (Equus africanus asinus).,"The goal of this study was to compare the efficiency of histrelin acetate (GnRH analog) and human chorionic gonadotropin (hCG) to hasten ovulation in Brazilian Northeastern jennies (Equus africanus asinus). Thirty cycles of ten jennies were randomly assigned in one of the three groups: G0 (control group), saline; G1, 250 μg of histrelin acetate; G2, 2500 IU of hCG. Jennies were evaluated by transrectal palpation and ultrasonography, and had the administration of an ovulation-inducing agent when a follicle measuring between 29 and 32 mm of diameter was diagnosed. Jennies were monitored every 6 hours by transrectal ultrasonography until ovulation. The interval between prostaglandin administration and ovulation was lower (P < .05) in jennies from the G1 (145.2 ± 34.6 hours) and G2 (147.4 ± 27.3 hours) groups compared with the control cycle (220.0 ± 41.8 hours). Both treatments (G1, 41.15 ± 3.5 hours; G2, 37.8 ± 2.5 hours) also reduced (P < .05) the interval that jennies took to ovulate after the administration of the ovulation-inducing agent compared with the control (81.8 ± 28.8 hours). All jennies from G1 and G2 ovulated up to 48 hours after ovulation induction, whereas 100% of jennies in the control cycle ovulated later (>48 hours from the administration of saline). In conclusion, both histrelin acetate and hCG at the used dose are efficient ovulation-inducing agents in jennies promoting ovulation up to 48 hours after administration.",2020,The interval between prostaglandin administration and ovulation was lower (P < .05) in jennies from the G1 (145.2 ± 34.6 hours) and G2 (147.4 ± 27.3 hours) groups compared with the control cycle (220.0 ± 41.8 hours).,"['Brazilian Northeastern Jennies (Equus africanus asinus', 'Thirty cycles of ten jennies']","['histrelin acetate (GnRH analog) and human chorionic gonadotropin (hCG', 'histrelin acetate and hCG', 'G0 (control group), saline; G1, 250\xa0μg of histrelin acetate; G2, 2500 IU of hCG', 'Histrelin Acetate and hCG']",['interval between prostaglandin administration and ovulation'],"[{'cui': 'C1265527', 'cui_str': 'Genus Equus'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0724597', 'cui_str': 'Histrelin acetate'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0428402', 'cui_str': 'Human chorionic gonadotropin measurement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C4319601', 'cui_str': '2500'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}]",,0.0674374,The interval between prostaglandin administration and ovulation was lower (P < .05) in jennies from the G1 (145.2 ± 34.6 hours) and G2 (147.4 ± 27.3 hours) groups compared with the control cycle (220.0 ± 41.8 hours).,"[{'ForeName': 'Sidnei N', 'Initials': 'SN', 'LastName': 'Oliveira', 'Affiliation': 'Sao Paulo State University (Unesp), School of Veterinary Medicine and Animal Science, Botucatu, Brazil. Electronic address: sidneino@gmail.com.'}, {'ForeName': 'Lorenzo G T M', 'Initials': 'LGTM', 'LastName': 'Segabinazzi', 'Affiliation': 'Sao Paulo State University (Unesp), School of Veterinary Medicine and Animal Science, Botucatu, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Canuto', 'Affiliation': 'Sao Paulo State University (Unesp), School of Veterinary Medicine and Animal Science, Botucatu, Brazil.'}, {'ForeName': 'Fernando P', 'Initials': 'FP', 'LastName': 'Lisboa', 'Affiliation': 'Caxias do Sul University, Caxias do Sul, RS, Brazil.'}, {'ForeName': 'Felipe E', 'Initials': 'FE', 'LastName': 'Medrado', 'Affiliation': 'Sao Paulo State University (Unesp), School of Veterinary Medicine and Animal Science, Botucatu, Brazil.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': ""Dell'Aqua"", 'Affiliation': 'Sao Paulo State University (Unesp), School of Veterinary Medicine and Animal Science, Botucatu, Brazil.'}, {'ForeName': 'Antonio J A', 'Initials': 'AJA', 'LastName': 'Aguiar', 'Affiliation': 'Sao Paulo State University (Unesp), School of Veterinary Medicine and Animal Science, Botucatu, Brazil.'}, {'ForeName': 'Frederico O', 'Initials': 'FO', 'LastName': 'Papa', 'Affiliation': 'Sao Paulo State University (Unesp), School of Veterinary Medicine and Animal Science, Botucatu, Brazil.'}]",Journal of equine veterinary science,['10.1016/j.jevs.2020.103146']
2071,32798022,Resection following concurrent chemotherapy and high-dose radiation for stage IIIA non-small cell lung cancer.,"OBJECTIVE


Concern exists regarding surgery after thoracic radiation. We aimed to assess early results of anatomic resection following induction therapy with platinum-based chemotherapy and full-dose thoracic radiation for resectable N2+ stage IIIA non-small cell lung cancer.
METHODS


Two prospective trials were recently conducted by NRG Oncology in patients with resectable N2+ stage IIIA non-small cell lung cancer with the primary end point of mediastinal node sterilization following concurrent full-dose chemoradiotherapy (Radiation Therapy Oncology Group trials 0229 and 0839). All surgeons demonstrated postinduction resection expertise. Induction consisted of weekly carboplatin (area under the curve, 2.0) and paclitaxel (50 mg/m 2 ) and concurrent thoracic radiation 60 Gy (0839)/61.2 Gy (0229) in 30 fractions. Patients in study 0839 were randomized 2:1 to weekly panitumumab + chemoradiotherapy or chemoradiotherapy alone during induction. Primary results were similar in all treatment arms and reported previously. Short-term surgical outcomes are reported here.
RESULTS


One hundred twenty-six patients enrolled; 93 (74%) had anatomic resection, 77 underwent lobectomy, and 16 underwent extended resection. Microscopically margin-negative resections occurred in 85 (91%). Fourteen (15%) resections were attempted minimally invasively, including 2 converted without event. Grade 3 or 4 surgical adverse events were reported in 26 (28%), 30-day mortality in 4 (4%) and 90-day mortality in 5 (5%). Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
CONCLUSIONS


Lobectomy was performed safely following full-dose concurrent chemoradiotherapy in these multi-institutional prospective trials; however, increased mortality was noted with extended resections.",2020,"Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
","['patients with resectable N2+ stage IIIA non-small cell lung cancer with the primary end point of mediastinal node sterilization following concurrent full-dose chemoradiotherapy (Radiation Therapy Oncology Group trials 0229 and 0839', 'One hundred twenty-six patients enrolled; 93 (74%) had anatomic resection, 77 underwent lobectomy, and 16 underwent extended resection', 'stage IIIA non-small cell lung cancer']","['anatomic resection following induction therapy with platinum-based chemotherapy and full-dose thoracic radiation', 'paclitaxel', 'carboplatin', 'concurrent chemotherapy and high-dose radiation', 'panitumumab\xa0+\xa0chemoradiotherapy or chemoradiotherapy']","['90-day mortality', 'Microscopically margin-negative resections', 'rates of grade 3 or 4 adverse events', 'mortality', '30-day mortality', 'Grade 3 or 4 surgical adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278983', 'cui_str': 'Non-small cell lung cancer stage IIIA'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0588055', 'cui_str': 'Mediastinal lymph node group'}, {'cui': 'C0038280', 'cui_str': 'Sterilization'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",839.0,0.482473,"Patients undergoing extended resection experienced similar rates of grade 3 or 4 adverse events (odds ratio, 0.95; 95% confidence interval, 0.42-3.8) but higher 30-day (1.3% vs 18.8%) (odds ratio, 17.54; 95% confidence interval, 1.75-181.8) and 90-day mortality (2.6% vs 18.8%) (odds ratio, 8.65; 95% confidence interval, 1.3-56.9).
","[{'ForeName': 'Jessica S', 'Initials': 'JS', 'LastName': 'Donington', 'Affiliation': 'Department of Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Ill. Electronic address: jdonington@uchicago.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Paulus', 'Affiliation': 'Department of Department of Surgery, University of Chicago Medicine and Biologic Sciences, Chicago, Ill.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Edelman', 'Affiliation': 'Division of Medical Oncology, Department of Medicine, University of Maryland Medical Center, Baltimore, Md.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Krasna', 'Affiliation': 'Department of Surgery, Jersey Shore University Medical Center, Neptune City, NJ.'}, {'ForeName': 'Quynh-Thu', 'Initials': 'QT', 'LastName': 'Le', 'Affiliation': 'Department of Radiation Oncology, Stanford Cancer Institute, Stanford, Calif.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Suntharalingam', 'Affiliation': 'Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, Md.'}, {'ForeName': 'Billy W', 'Initials': 'BW', 'LastName': 'Loo', 'Affiliation': 'Department of Radiation Oncology, Stanford Cancer Institute, Stanford, Calif.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Philadelphia, Pa; Division of Biostatistics and Bioinformatics, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Md.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Bradley', 'Affiliation': 'Department of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Ga.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2020.03.171']
2072,32798112,"Percutaneous reduction, cannulated screw fixation and calcium sulfate cement grafting assisted by 3D printing technology in the treatment of calcaneal fractures.","BACKGROUND


Percutaneous reduction, cannulated screw fixation and calcium sulfate cement grafting (PR + CSC) for treatment of displaced and intra-articular calcaneal fractures (DIACFs) is a difficult technique, because the minimally invasive treatment has limited exposure and cannot be used to reduce articular surface under direct vision. The goal of this study was to apply 3D printing technology to preoperative planning and surgery of DIACFs, and to evaluate its effectiveness, feasibility and safety in fracture repair.
METHODS


We enrolled 81 patients with DIACFs in the study from August 2015 to August 2017. Patients with DIACFs in our hospital were randomly divided into the 3D printing group (40 cases) and the conventional group (41 cases). The operation duration, blood loss volume and the number of fluoroscopy were compared. Radiological results were evaluated using radiographs and functional results were evaluated using the American Orthopedic Foot and Ankle Society (AOFAS) score. The complications were also assessed. In addition, we made a questionnaire to verify the usefulness of the 3D printed model for both doctors and patients.
RESULTS


The operation duration, blood loss volume and the number of fluoroscopy in 3D printing group were significantly less than that in the conventional group. Besides, 3D printing group achieved significantly better radiological results than conventional group both postoperatively and at the final follow-up except the calcaneal width at the final follow-up. The AOFAS score in the 3D printing group was significantly higher than that in the conventional group. In addition, the questionnaire from doctors and patients exhibited high scores of overall satisfaction of the 3D printed models. As for complications, there was no significant difference among the two groups.
CONCLUSION


This study suggested the clinical feasibility of PR + CSC assisted by 3D printing technology in the treatment of DIACFs.
LEVEL OF EVIDENCE


II.",2020,"Besides, 3D printing group achieved significantly better radiological results than conventional group both postoperatively and at the final follow-up except the calcaneal width at the final follow-up.","['calcaneal fractures', 'Patients with DIACFs in our hospital', '81 patients with DIACFs in the study from August 2015 to August 2017']","['cannulated screw fixation and calcium sulfate cement grafting (PR\xa0+\xa0CSC', 'Percutaneous reduction, cannulated screw fixation and calcium sulfate cement grafting']","['American Orthopedic Foot and Ankle Society (AOFAS) score', 'radiological results', 'operation duration, blood loss volume and the number of fluoroscopy', 'AOFAS score']","[{'cui': 'C0006655', 'cui_str': 'Bone structure of calcaneum'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0006720', 'cui_str': 'Calcium Sulfate'}, {'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0730328', 'cui_str': 'Central serous chorioretinopathy'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}]","[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}]",81.0,0.0180902,"Besides, 3D printing group achieved significantly better radiological results than conventional group both postoperatively and at the final follow-up except the calcaneal width at the final follow-up.","[{'ForeName': 'Gaole', 'Initials': 'G', 'LastName': 'Dai', 'Affiliation': ""Department of Orthopaedics, Key Laboratory of Orthopaedics of Zhejiang Province, The Second School of Medicine of Wenzhou Medical University, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Zhenxuan', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': ""Department of Orthopaedics, Key Laboratory of Orthopaedics of Zhejiang Province, The Second School of Medicine of Wenzhou Medical University, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Qihao', 'Initials': 'Q', 'LastName': 'Weng', 'Affiliation': ""Department of Orthopaedics, Key Laboratory of Orthopaedics of Zhejiang Province, The Second School of Medicine of Wenzhou Medical University, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Yijing', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Department of Orthopaedics, Key Laboratory of Orthopaedics of Zhejiang Province, The Second School of Medicine of Wenzhou Medical University, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.""}, {'ForeName': 'Jianjun', 'Initials': 'J', 'LastName': 'Hong', 'Affiliation': ""Department of Orthopaedics, Key Laboratory of Orthopaedics of Zhejiang Province, The Second School of Medicine of Wenzhou Medical University, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China. Electronic address: JianjunHong123@126.com.""}, {'ForeName': 'Xiaolang', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': ""Department of Orthopaedics, Key Laboratory of Orthopaedics of Zhejiang Province, The Second School of Medicine of Wenzhou Medical University, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China. Electronic address: XiaolangLu@126.com.""}]",Journal of orthopaedic science : official journal of the Japanese Orthopaedic Association,['10.1016/j.jos.2020.06.008']
2073,32791322,The Aging PLUS  trial: Design of a randomized controlled trial to increase physical activity in middle-aged and older adults.,"BACKGROUND


Negative views of aging (NVOA), low self-efficacy beliefs, and poor goal planning skills represent risk factors that undermine adults' motivation to engage in physical activity (PA). Targeting these three risk factors may motivate adults to become physically active.
OBJECTIVE


To assess the efficacy of Aging PLUS , a 4-week educational program that explicitly targets NVOA, low self-efficacy beliefs, and poor goal planning skills compared to a 4-week health education program. The study also examines the role of NVOA, self-efficacy beliefs, and goal planning as the mechanisms underlying change in PA.
DESIGN


This randomized controlled trial (RCT) utilizes the experimental medicine approach to assess change in PA as a function of modifying three risk factors. The RCT recruitment target includes 288 mostly sedentary adults ranging in age from 45 to 75 years.
METHODS


Eligible middle-aged and older adults are recruited through community sources. Participants are randomized to either the Aging PLUS  or the control group. Participants in both groups are enrolled in the trial for 8 months total, with four assessment points: Baseline (pre-test), Week 4 (immediate post-test), Week 8 (delayed post-test), and Month 6 (long-term follow-up). The intervention takes place over 4 consecutive weeks with 2-h sessions each week. PA engagement is the primary outcome variable. Positive changes in NVOA, self-efficacy beliefs, and goal planning are the intervention targets and hypothesized mediators of increases in PA.
SUMMARY


By utilizing a multi-component approach and targeting a cluster of psychological mechanisms, the Aging PLUS  program implements the experimental medicine approach to health behavior change.",2020,"Positive changes in NVOA, self-efficacy beliefs, and goal planning are the intervention targets and hypothesized mediators of increases in PA.
","['middle-aged and older adults', '288 mostly sedentary adults ranging in age from 45 to 75\u202fyears', 'Eligible middle-aged and older adults']",[],"['physical activity', 'Positive changes in NVOA, self-efficacy beliefs']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",288.0,0.0622321,"Positive changes in NVOA, self-efficacy beliefs, and goal planning are the intervention targets and hypothesized mediators of increases in PA.
","[{'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Diehl', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States. Electronic address: manfred.diehl@colostate.edu.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Nehrkorn-Bailey', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Thompson', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Kaigang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'George W', 'Initials': 'GW', 'LastName': 'Rebok', 'Affiliation': 'Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Roth', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, School of Medicine, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Shang-En', 'Initials': 'SE', 'LastName': 'Chung', 'Affiliation': 'Division of Geriatric Medicine and Gerontology, School of Medicine, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Bland', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Skylar', 'Initials': 'S', 'LastName': 'Feltner', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Garrett', 'Initials': 'G', 'LastName': 'Forsyth', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Hulett', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Berkeley', 'Initials': 'B', 'LastName': 'Klein', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Mars', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Martinez', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mast', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Monasterio', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Moore', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Hayden', 'Initials': 'H', 'LastName': 'Schoenberg', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Thomson', 'Affiliation': 'Department of Health and Exercise Science, Colorado State University, Fort Collins, CO, United States.'}, {'ForeName': 'Han-Yun', 'Initials': 'HY', 'LastName': 'Tseng', 'Affiliation': 'Department of Human Development and Family Studies, Colorado State University, 1570 Campus Delivery, Fort Collins, CO 80523-1570, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106105']
2074,32791393,A Prospective Randomized Control Study Comparing the Effects of Dermal Staples and Intradermal Sutures on Postoperative Scarring After Thyroidectomy.,"BACKGROUND


We compared cosmetic outcomes, pain intensity, and costs between dermal stapling and intradermal suturing in patients who underwent thyroidectomy through cervical incision.
PATIENTS AND METHODS


In total, 40 patients were randomly assigned to undergo thyroidectomy through a low cervical incision and dermal closure using either absorbable staples (n = 20, staple group) or interrupted intradermal sutures (n = 20, suture group). Wound complications, cosmetic outcomes (modified Stony Brook Scar Evaluation Scale [SBSES] and Manchester Scar Scale [MSS]), and pain intensity (visual analog scale) were assessed at 1, 4, 12, and 24 weeks postoperatively. The difference in total ""wound-closure cost"" between the two groups was also analyzed.
RESULTS


There were no wound-related complications and no significant differences in SBSES or MSS scores between the two groups (P = 0.609 and P = 0.141, respectively). However, the staple group had significantly higher SBSES scores, compared to the suture group, at 24 wk postoperatively (4.06 ± 0.94 versus 3.26 ± 1.24; P = 0.030, respectively); MSS scores were significantly lower in the staple group than in the suture group at 24 wk postoperatively (6.72 ± 1.27 versus 8.16 ± 2.17, respectively; P = 0.028). Visual analog scale scores were significantly lower in the suture group than in the staple group (P = 0.038). The total wound-closure cost was significantly higher in the staple group than in the suture group (137.10 ± 8.39 versus 81.79 ± 19.95 USD; P < 0.001).
CONCLUSIONS


When dermal staples were used, wound complications were absent and long-term cosmetic outcomes were superior; however, pain intensity was higher and the cost was greater, although healing was significantly more rapid, compared to intradermal sutures. Closure using absorbable dermal staples may be safe and effective for cervical incisions during thyroid surgery. Further studies with larger number of participants are needed to confirm our findings.",2020,"There were no wound-related complications and no significant differences in SBSES or MSS scores between the two groups (P = 0.609 and P = 0.141, respectively).","['patients who underwent thyroidectomy through cervical incision', '40 patients']","['thyroidectomy through a low cervical incision and dermal closure using either absorbable staples (n\xa0=\xa020, staple group) or interrupted intradermal sutures', 'Dermal Staples and Intradermal Sutures', 'dermal stapling and intradermal suturing']","['Postoperative Scarring', 'total wound-closure cost', 'total ""wound-closure cost', 'healing', 'pain intensity', 'MSS scores', 'wound complications', 'Wound complications, cosmetic outcomes (modified Stony Brook Scar Evaluation Scale [SBSES] and Manchester Scar Scale [MSS]), and pain intensity (visual analog scale', 'pain intensity, and costs', 'SBSES or MSS scores', 'Visual analog scale scores', 'SBSES scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0442944', 'cui_str': 'Incision of neck'}]","[{'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0442944', 'cui_str': 'Incision of neck'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0524724', 'cui_str': 'Surgical staple'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0185012', 'cui_str': 'Closure by staple'}]","[{'cui': 'C0334150', 'cui_str': 'Surgical scar'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0024814', 'cui_str': 'Marinesco-Sjögren syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003380', 'cui_str': 'Antimony'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",40.0,0.0378732,"There were no wound-related complications and no significant differences in SBSES or MSS scores between the two groups (P = 0.609 and P = 0.141, respectively).","[{'ForeName': 'Dohoe', 'Initials': 'D', 'LastName': 'Ku', 'Affiliation': 'Department of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.'}, {'ForeName': 'Do Hoon', 'Initials': 'DH', 'LastName': 'Koo', 'Affiliation': 'Department of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.'}, {'ForeName': 'Dong Sik', 'Initials': 'DS', 'LastName': 'Bae', 'Affiliation': 'Department of Surgery, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea. Electronic address: md.ds.bae@gmail.com.'}]",The Journal of surgical research,['10.1016/j.jss.2020.06.052']
2075,32791434,Factors associated with readiness to quit smoking among young adults enrolled in a Facebook-based tobacco and alcohol intervention study.,"INTRODUCTION


Young adults who smoke cigarettes often report heavy episodic drinking (HED) and co-use of other psychoactive substances which may complicate efforts to quit cigarette smoking. The current study examined factors associated with readiness to quit cigarette smoking among young adults who smoke and engage in HED.
METHODS


One hundred seventy-nine young adults aged 18 to 25 who reported regular cigarette smoking and past month HED enrolled in the 90-day Facebook-based Smoking Tobacco and Drinking (STAND) intervention study. Analyses compared baseline differences in patterns of cigarette smoking and alcohol and cannabis use, thoughts about abstinence, use of nicotine replacement therapy (NRT), sociodemographic characteristics, and other health behaviors between participants who were ready to quit cigarette smoking in the next 30 days and those who were not.
RESULTS


Participants were 40.2% female, 49.7% male, 10.1% non-binary, and 80.4% Non-Hispanic White. They reported on average moderate nicotine dependence (FTCD), moderate risk for alcohol use disorder (AUDIT), and occasional or regular cannabis use. Readiness to quit cigarette smoking in the next 30 days (33.5%) was positively associated with age (p = .021), NRT use in the past 30 days (p = .037) and perceived importance to also reduce alcohol use (p = .033).
CONCLUSIONS


Findings indicate that readiness to quit cigarette smoking among young adults who drink is positively associated with importance to reduce alcohol use, but not with use patterns or levels of dependence. Interventions addressing polysubstance use may be better suited to help young adults reduce or quit cigarette smoking once they signal readiness for behavior change.",2020,"Readiness to quit cigarette smoking in the next 30 days (33.5%) was positively associated with age (p = .021), NRT use in the past 30 days (p = .037) and perceived importance to also reduce alcohol use (p = .033).
","['One hundred seventy-nine young adults aged 18 to 25 who reported regular cigarette smoking and past month HED enrolled in the 90-day Facebook-based Smoking Tobacco and Drinking (STAND) intervention study', 'young adults who smoke and engage in HED', 'young adults enrolled in a Facebook-based tobacco and alcohol intervention study', 'Young adults who smoke cigarettes often report heavy episodic drinking (HED', 'Participants were 40.2% female, 49.7% male, 10.1% non-binary, and 80.4% Non-Hispanic White']",[],"['Readiness to quit cigarette smoking', 'cigarette smoking and alcohol and cannabis use, thoughts about abstinence, use of nicotine replacement therapy (NRT), sociodemographic characteristics, and other health behaviors']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439994', 'cui_str': 'Tobacco smoke'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]",[],"[{'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0239059', 'cui_str': 'Cigarette smoke'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",179.0,0.016447,"Readiness to quit cigarette smoking in the next 30 days (33.5%) was positively associated with age (p = .021), NRT use in the past 30 days (p = .037) and perceived importance to also reduce alcohol use (p = .033).
","[{'ForeName': 'Larissa J', 'Initials': 'LJ', 'LastName': 'Maier', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, CA, United States; Early Postdoc. Mobility Grantee (P2ZHP1_174812), Swiss National Science Foundation, Bern, Switzerland. Electronic address: larissa.maier@ucsf.edu.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Ramo', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, CA, United States. Electronic address: Danielle.Ramo@ucsf.edu.'}, {'ForeName': 'Manpreet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, CA, United States. Electronic address: manpreetkaurkh@gmail.com.'}, {'ForeName': 'Meredith C', 'Initials': 'MC', 'LastName': 'Meacham', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, CA, United States. Electronic address: meredith.meacham@ucsf.edu.'}, {'ForeName': 'Derek D', 'Initials': 'DD', 'LastName': 'Satre', 'Affiliation': 'Department of Psychiatry and Weill Institute for Neurosciences, University of California, San Francisco, CA, United States; Kaiser Permanente Northern California, Division of Research, Oakland, CA, United States. Electronic address: derek.satre@ucsf.edu.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106524']
2076,32791704,"Evaluation of efficacy and safety of single and multiple therapy of herbal medicine/Chuna therapy on non-specific chronic low back pain: A study protocol for multicenter, 3-arm, randomized, single blinded, parallel group, incomplete factorial design, pilot study.","INTRODUCTION


Chronic non-specific low back pain is one of the common health issues which reduce the quality of life and in working population. While combined therapeutic treatment method is widely used for musculoskeletal related disorders in Korea, well-developed trials on the efficacy of single or combine therapy on herbal medicine and Chuna manual therapy (CMT) are scarce.
OBJECTIVE


This study aims to evaluate the clinical efficacy and safety of herbal medicine, Sogyeonghwalhyeol-tang (SGHH) on work related chronic low back pain patients. The primary aim is to determine the efficacy of a combined multidisciplinary approach using SGHH with CMT compared to SGHH alone. The secondary aim is to examine the naïve direct comparison between SGHH and placebo.
METHOD


This trial is designed as a multicenter, randomized, controlled, clinical trial. A total of 150 participants who have with chief complaint of low back pain in Korean medicine rehabilitation center will be randomly assigned to 1 of 3 treatments with a ratio of 1:1:1. Eligible participant will be randomized to treatment arm A receive single treatment of Sogyeonghwalhyeol-tang, in treatment Arm B Sogyeonghwalhyeol-tang and Chuna manual therapy are administered concurrently, in treatment arm C, where individuals receive placebo with Chuna manual therapy. They will receive assigned treatment in 4 weeks and follow-up for 4 weeks. The primary endpoint is to assess the change in severity of low back pain from baseline. The secondary endpoints are the following: the changes in disability and health related quality of life. Adverse events will also be reported.
DISCUSSION


The study result will provide the valuable information for efficacy and safety of monotherapy and multiple therapy of herbal medicinal extract and Chuna manual therapy on chronic non-specific low back pain.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03132974.",2020,The primary aim is to determine the efficacy of a combined multidisciplinary approach using SGHH with CMT compared to SGHH alone.,"['non-specific chronic low back pain', 'chronic low back pain patients', '150 participants who have with chief complaint of low back pain in Korean medicine rehabilitation center']","['herbal medicine, Sogyeonghwalhyeol-tang (SGHH', 'placebo with Chuna manual therapy', 'herbal medicine/Chuna therapy', 'SGHH and placebo', 'Sogyeonghwalhyeol-tang, in treatment Arm B Sogyeonghwalhyeol-tang and Chuna manual therapy', 'herbal medicinal extract and Chuna manual therapy']","['change in severity of low back pain', 'disability and health related quality of life']","[{'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",150.0,0.222222,The primary aim is to determine the efficacy of a combined multidisciplinary approach using SGHH with CMT compared to SGHH alone.,"[{'ForeName': 'Youme', 'Initials': 'Y', 'LastName': 'Ko', 'Affiliation': 'aDepartment of Science in Korean Medicine, Graduate School, Kyung Hee University, Seoul bDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Dae-Jeon University, Daejeon cDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Semyung University, Jecheon dDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Woosuk University, Jecheon eJaseng Spine and Joint Research Institute, Jaseng Medical Foundation, Seoul fJaseng Hospital of Korean Medicine, Seoul gDepartment of Korean Rehabilitation Medicine, College of Korean Medicine, Gachon University, Seongnam-si, Republic of Korea.'}, {'ForeName': 'Bo-Hyoung', 'Initials': 'BH', 'LastName': 'Jang', 'Affiliation': ''}, {'ForeName': 'Min-Seok', 'Initials': 'MS', 'LastName': 'Oh', 'Affiliation': ''}, {'ForeName': 'Sun Joong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Yeon-Seok', 'Initials': 'YS', 'LastName': 'Ko', 'Affiliation': ''}, {'ForeName': 'In-Hyuk', 'Initials': 'IH', 'LastName': 'Ha', 'Affiliation': ''}, {'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Me-Riong', 'Initials': 'MR', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Yun-Kyung', 'Initials': 'YK', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Seong-Gyu', 'Initials': 'SG', 'LastName': 'Ko', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021260']
2077,32791711,Effect of low frequency repetitive magnetic stimulation at Shenmen (HT7) on sleep quality in patients with chronic insomnia.,"BACKGROUND


Insomnia is a common, recurrent, and tenacious sleep problem, especially the chronic insomnia. Repetitive transcranial magnetic stimulation (rTMS) at right dorsolateral prefrontal cortex (r-DLPFC) is used in chronic insomnia, and repetitive magnetic stimulation (rMS) at Shenmen (HT7) acupoint may be an alternative approach. However, the efficacy and mechanism of rMS at HT7 acupoint for chronic insomnia has not been confirmed.
METHODS/DESIGN


This is a 3-armed randomized positive-controlled noninferiority clinical trial. We will allocate 45 subjects aged between 18 and 65 years old, diagnosed with initial chronic insomnia over 3 months to 3 groups randomly in a ratio of 1:1:1. Patients in the experimental group will be treated with rMS at HT7 acupoint while the others in the control group will be treated with rTMS at r-DLPFC or waiting treatment. All will be given rMS at HT7 or rTMS at r-DLPFC or no treatment for 10 days, and then received 20-day follow-up. Patients will be evaluated with the insomnia severity index and Pittsburgh sleep quality index for sleep state, Beck Depression Inventory-2nd edition scores for the depression state, Beck anxiety inventory scores for the anxiety state, and Montreal Cognitive Assessment scores for the cognition state before and the 10th day of treatment, 30th day of follow-up; study on mechanisms of rMS will be revealed through the resting motor threshold diversity of the motor cortex before and the 10th day of treatment, 30th day of follow-up. Baseline characteristics of patients will be summarized by groups and compared with Chi-squared for categorical variables, and analysis of variance or Kruskal-Wallis test for the continuous variables. Primary and secondary outcomes according to the measurement times are applicable to univariate repetitive measurement deviation analysis or analysis of variance, or Kruskal-Wallis test.
CONCLUSION


The present study is designed to preliminarily investigate short-term efficacy and mechanism of rMS at HT7 acupoint therapy on chronic insomnia, also to explore the correlation between motor cortex excitability and chronic insomnia. With this research, we are looking forward to find out an appropriate alternative and easy therapy for chronic insomnia individuals compared with rTMS at r-DLPFC.
TRIAL REGISTRATION


The trial was registered on Chinese Clinical Trial Registry (http://www.chictr.org.cn/index.aspx) with the ID ChiCTR1900026844 on October 24, 2019.",2020,"The present study is designed to preliminarily investigate short-term efficacy and mechanism of rMS at HT7 acupoint therapy on chronic insomnia, also to explore the correlation between motor cortex excitability and chronic insomnia.","['45 subjects aged between 18 and 65 years old, diagnosed with initial chronic insomnia over 3 months to 3 groups randomly in a ratio of 1:1:1', 'patients with chronic insomnia']","['rMS at HT7 acupoint', 'Repetitive transcranial magnetic stimulation (rTMS', 'repetitive magnetic stimulation (rMS) at Shenmen (HT7) acupoint', 'rMS at HT7 acupoint therapy', 'rTMS at r-DLPFC or waiting treatment', 'HT7 acupoint', 'low frequency repetitive magnetic stimulation at Shenmen (HT7']","['univariate repetitive measurement deviation analysis or analysis of variance, or Kruskal-Wallis test', 'chronic insomnia', 'insomnia severity index and Pittsburgh sleep quality index for sleep state, Beck Depression Inventory-2nd edition scores for the depression state, Beck anxiety inventory scores for the anxiety state, and Montreal Cognitive Assessment scores', 'sleep quality']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0450571', 'cui_str': 'HT7'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}]","[{'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0002780', 'cui_str': 'Analysis, Variance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0751249', 'cui_str': 'Chronic insomnia'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4274492', 'cui_str': 'Beck Anxiety Inventory score'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]",45.0,0.0701115,"The present study is designed to preliminarily investigate short-term efficacy and mechanism of rMS at HT7 acupoint therapy on chronic insomnia, also to explore the correlation between motor cortex excitability and chronic insomnia.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': ""aSchool of Basic Medical Sciences, Chengdu University of Traditional Chinese Medicine, Chengdu bDepartment of Encephalopathy, Shaanxi Provincial Hospital of Traditional Chinese Medicine cSyndrome and Treatment Research Office For Insomnia With Yin Yang Sequential Treatment, Shaanxi Administration of Traditional Chinese Medicine dDepartment of Geriatrics, Xi'an Hospital of Traditional Chinese Medicine, Xi'an, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Yaling', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ''}, {'ForeName': 'Zhaoxin', 'Initials': 'Z', 'LastName': 'Wan', 'Affiliation': ''}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Zucheng', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Dongling', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Luo', 'Affiliation': ''}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021292']
2078,32791715,Difference in the metabolic characteristics of chronic obstructive pulmonary disease patients and healthy adults.,"INTRODUCTION


By detecting the metabolic difference of the Heart and Lung meridians, the present study aims to investigate the specificity of different meridians and verify whether functional near infrared spectroscopy is validated as an add-on technique to assist diagnosis of chronic obstructive pulmonary disease (COPD).
METHODS AND ANALYSIS


The Lung and Heart meridians are chosen as the target for comparison; accordingly, 120 eligible participants will be included and divided into the COPD group, healthy control group, and healthy intervention group. Functional near infrared spectroscopy will be adopted to measure the metabolic characteristics of the Heart and Lung meridians. On one hand, the specificity of the meridian-visceral association will be investigated by comparing the metabolic difference in the Heart and Lung meridians between the healthy control group and COPD group. On the other hand, the specificity of site-to-site association will be determined by comparing the metabolic change between the 2 meridians that induced by moxibustion in the Heart meridian and Lung meridian, respectively, in the healthy control group. The primary outcome will be regional oxygen saturation of corresponding regions along the Heart and Lung meridians.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04046666.",2020,"On one hand, the specificity of the meridian-visceral association will be investigated by comparing the metabolic difference in the Heart and Lung meridians between the healthy control group and COPD group.","['120 eligible participants will be included and divided into the COPD group, healthy control group, and healthy intervention group', 'chronic obstructive pulmonary disease (COPD', 'chronic obstructive pulmonary disease patients and healthy adults']",[],['regional oxygen saturation of corresponding regions along the Heart and Lung meridians'],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0085282', 'cui_str': 'Jingluo'}]",120.0,0.0505464,"On one hand, the specificity of the meridian-visceral association will be investigated by comparing the metabolic difference in the Heart and Lung meridians between the healthy control group and COPD group.","[{'ForeName': 'Yongliang', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'aDepartment of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Hangzhou bThe Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou City, Zhejiang Province, China.'}, {'ForeName': 'Hantong', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xiaofen', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ''}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Shao', 'Affiliation': ''}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Lou', 'Affiliation': ''}, {'ForeName': 'Yajun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Jianqiao', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021302']
2079,32791720,Ear mold for congenital ear malformation: A randomized controlled trial.,"BACKGROUND


Congenital auricular deformities (CAD) are prevalent worldwide. The objective of this study is to investigate the effectiveness and safety of ear molding for children with CAD at their early days.
METHODS


One hundred and nighty children (under 3 days) with CAD will be included in the study. Participants will be randomly allocated to treatment or waiting list group (n = 95). The treatment group will receive ear molding within 3 days after birth for 2 weeks. The control group will receive usual care and receive the same ear molding at 6th week if spontaneously recover is not occur. Physician and parent assessment of improvement, parent's anxiety, depression, and quality of life and adverse events will be measured at baseline, 3rd and 6th week of initial treatment. The primary outcome recovery rate will be compared between groups using Chi square test. Secondary continuous outcomes will be compared using analysis of variance.
DISCUSSION


This study is the first randomized controlled trial to examine the effectiveness, safety and cost-effectiveness of ear molding for CAD comparing with waiting list, to inform clinical decision of CAD treatments and relevant guideline development.",2020,"This study is the first randomized controlled trial to examine the effectiveness, safety and cost-effectiveness of ear molding for CAD comparing with waiting list, to inform clinical decision of CAD treatments and relevant guideline development.","['One hundred and nighty children (under 3 days) with CAD will be included in the study', 'children with CAD at their early days', 'Congenital auricular deformities (CAD', 'ear malformation']",['waiting list group'],"['effectiveness, safety and cost-effectiveness', 'recovery rate', ""Physician and parent assessment of improvement, parent's anxiety, depression, and quality of life and adverse events""]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009678', 'cui_str': 'congenital'}, {'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0266589', 'cui_str': 'Congenital malformation of ear'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.171539,"This study is the first randomized controlled trial to examine the effectiveness, safety and cost-effectiveness of ear molding for CAD comparing with waiting list, to inform clinical decision of CAD treatments and relevant guideline development.","[{'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zou', 'Affiliation': ""aDepartment of Health Policy and Management bWest China Research Centre for Rural Health Development, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, Sichuan cNational Center for Women and Children's Health, China Center for Disease Control and Prevention, Beijing dDepartment of Health-Related Social and Behavioral Sciences eDepartment of Epidemiology and Biostatistics, West China School of Public Health and West China Fourth Hospital, Sichuan University fDepartment of Pharmacy, West China Second Hospital, Sichuan University gEvidence-Based Pharmacy Center, West China Second Hospital, Sichuan University, Chengdu, Sichuan, China hFaculty of Health, Art and Design, Swinbune Technology University, Melbourne, Australia.""}, {'ForeName': 'Yanjun', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ''}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': ''}, {'ForeName': 'Jincheng', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Yunqi', 'Initials': 'Y', 'LastName': 'Miao', 'Affiliation': ''}, {'ForeName': 'Chunsong', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000021313']
2080,32791950,Plaque Regression and Endothelial Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen (PREMIER).,"BACKGROUND


Low-density lipoproteins (LDLs) are removed by extracorporeal filtration during LDL apheresis. It is mainly used in familial hyperlipidemia. The PREMIER trial (Plaque Regression and Progenitor Cell Mobilization With Intensive Lipid Elimination Regimen) evaluated LDL apheresis in nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention.
METHODS


We randomized 160 acute coronary syndrome patients at 4 Veterans Affairs centers within 72 hours of percutaneous coronary intervention to intensive lipid-lowering therapy (ILLT) comprising single LDL apheresis and statins versus standard medical therapy (SMT) with no LDL apheresis and statin therapy alone. Trial objectives constituted primary safety and primary efficacy end points and endothelial progenitor cell colony-forming unit mobilization in peripheral blood.
RESULTS


Mean LDL reduction at discharge was 53% in ILLT and 17% in SMT groups ( P <0.0001) from baseline levels of 116.3±34.3 and 110.7±32 mg/dL ( P =0.2979), respectively. The incidence of the primary safety end point of major peri-percutaneous coronary intervention adverse events was similar in both groups (ILLT, 3; SMT, 0). The primary efficacy end point, percentage change in total plaque volume at 90 days by intravascular ultrasound, on average decreased by 4.81% in the ILLT group and increased by 2.31% in the SMT group (difference of means, -7.13 [95% CI, -14.59 to 0.34];  P =0.0611). The raw change in total plaque volume on average decreased more in the ILLT group than in the SMT group (-6.01 versus -0.95 mm 3 ; difference of means, -5.06 [95% CI, -11.61 to 1.48];  P =0.1286). Similar results were obtained after adjusting for participating sites, age, preexisting coronary artery disease, diabetes mellitus, baseline LDL levels, and baseline plaque burden. There was robust endothelial progenitor cell colony-forming unit mobilization from baseline to 90 days in the ILLT group ( P =0.0015) but not in SMT ( P =0.0844).
CONCLUSIONS


PREMIER is the first randomized clinical trial to demonstrate safety and a trend for early coronary plaque regression with LDL apheresis in nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01004406 and NCT02347098.",2020,"RESULTS


Mean LDL reduction at discharge was 53% in ILLT and 17% in SMT groups ( P <0.0001) from baseline levels of 116.3±34.3 and 110.7±32 mg/dL ( P =0.2979), respectively.","['nonfamilial hyperlipidemia acute coronary syndrome patients treated with percutaneous coronary intervention', '160 acute coronary syndrome patients at 4 Veterans Affairs centers within 72 hours of']","['percutaneous coronary intervention to intensive lipid-lowering therapy (ILLT) comprising single LDL apheresis and statins versus standard medical therapy (SMT) with no LDL apheresis and statin therapy alone', 'ILLT', 'SMT', 'Intensive Lipid Elimination Regimen (PREMIER', 'LDL apheresis', 'endothelial progenitor cell colony-forming unit mobilization']","['Mean LDL reduction at discharge', 'total plaque volume', 'major peri-percutaneous coronary intervention adverse events', 'Plaque Regression and Endothelial Progenitor Cell Mobilization', 'endothelial progenitor cell colony-forming unit mobilization']","[{'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1292423', 'cui_str': '72 hours'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0949035', 'cui_str': 'Low density lipoprotein apheresis'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",160.0,0.0519883,"RESULTS


Mean LDL reduction at discharge was 53% in ILLT and 17% in SMT groups ( P <0.0001) from baseline levels of 116.3±34.3 and 110.7±32 mg/dL ( P =0.2979), respectively.","[{'ForeName': 'Subhash', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Veterans Affairs North Texas Health Care System, Dallas (S.B., J.L.H.).'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Luo', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Edward Hines, Jr Veterans Affairs Hospital, Hines, IL (P.L., D.J.R., D.L., Y.W.).'}, {'ForeName': 'Domenic J', 'Initials': 'DJ', 'LastName': 'Reda', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Edward Hines, Jr Veterans Affairs Hospital, Hines, IL (P.L., D.J.R., D.L., Y.W.).'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Latif', 'Affiliation': 'Oklahoma City Veterans Affairs Medical Center (F.L.).'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Hastings', 'Affiliation': 'Veterans Affairs North Texas Health Care System, Dallas (S.B., J.L.H.).'}, {'ForeName': 'Ehrin J', 'Initials': 'EJ', 'LastName': 'Armstrong', 'Affiliation': 'Rocky Mountain Regional Veterans Affairs Medical Center, Aurora, CO (E.J.A.).'}, {'ForeName': 'Jayant', 'Initials': 'J', 'LastName': 'Bagai', 'Affiliation': 'Veterans Affairs Tennessee Valley Health Care System, Nashville (J.B.).'}, {'ForeName': 'Mazen', 'Initials': 'M', 'LastName': 'Abu-Fadel', 'Affiliation': 'University of Oklahoma Health Sciences Center (F.L., M.A.-F.).'}, {'ForeName': 'Amutharani', 'Initials': 'A', 'LastName': 'Baskar', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas (S.B., J.L.H., A.B., P.K.).'}, {'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Kamath', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas (S.B., J.L.H., A.B., P.K.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lippe', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Edward Hines, Jr Veterans Affairs Hospital, Hines, IL (P.L., D.J.R., D.L., Y.W.).'}, {'ForeName': 'Yongliang', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Edward Hines, Jr Veterans Affairs Hospital, Hines, IL (P.L., D.J.R., D.L., Y.W.).'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Scrymgeour', 'Affiliation': 'Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM (A.S.).'}, {'ForeName': 'Theresa C', 'Initials': 'TC', 'LastName': 'Gleason', 'Affiliation': 'Department of Veterans Affairs, Office of Research and Development, Washington, DC (T.C.G.).'}, {'ForeName': 'Emmanouil S', 'Initials': 'ES', 'LastName': 'Brilakis', 'Affiliation': 'Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (E.S.B.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008933']
2081,32791973,"Nicotinamide riboside with pterostilbene (NRPT) increases NAD +  in patients with acute kidney injury (AKI): a randomized, double-blind, placebo-controlled, stepwise safety study of escalating doses of NRPT in patients with AKI.","BACKGROUND


Preclinical studies have identified both NAD +  and sirtuin augmentation as potential strategies for the prevention and treatment of AKI. Nicotinamide riboside (NR) is a NAD +  precursor vitamin and pterostilbene (PT) is potent sirtuin activator found in blueberries. Here, we tested the effect of combined NR and PT (NRPT) on whole blood NAD +  levels and safety parameters in patients with AKI.
METHODS


We conducted a randomized, double-blind, placebo-controlled study of escalating doses of NRPT in 24 hospitalized patients with AKI. The study was comprised of four Steps during which NRPT (5 subjects) or placebo (1 subject) was given twice a day for 2 days. NRPT dosing was increased in each Step: Step 1250/50 mg, Step 2500/100 mg, Step 3750/150 mg and Step 41,000/200 mg. Blood NAD +  levels were measured by liquid chromatography-mass spectrometry and safety was assessed by history, physical exam, and clinical laboratory testing.
RESULTS


AKI resulted in a 50% reduction in whole blood NAD +  levels at 48 h compared to 0 h in patients receiving placebo (p = 0.05). There was a trend for increase in NAD +  levels in all NRPT Steps individually at 48 h compared to 0 h, but only the change in Step 2 reached statistical significance (47%, p = 0.04), and there was considerable interindividual variability in the NAD +  response to treatment. Considering all Steps together, NRPT treatment increased NAD +  levels by 37% at 48 h compared to 0 h (p = 0.002). All safety laboratory tests were unchanged by NRPT treatment, including creatinine, estimated glomerular filtration rate (eGFR), electrolytes, liver function tests, and blood counts. Three of 20 patients receiving NRPT reported minor gastrointestinal side effects.
CONCLUSION


NRPT increases whole blood NAD +  levels in hospitalized patients with AKI. In addition, NRPT up to a dose of 1000 mg/200 mg twice a day for 2 days is safe and well tolerated in these patients. Further studies to assess the potential therapeutic benefit of NRPT in AKI are warranted.
TRIAL REGISTRATION


NCT03176628 , date of registration June 5th, 2017.",2020,"There was a trend for increase in NAD +  levels in all NRPT Steps individually at 48 h compared to 0 h, but only the change in Step 2 reached statistical significance (47%, p = 0.04), and there was considerable interindividual variability in the NAD +  response to treatment.","['patients with AKI', '20 patients receiving', '24 hospitalized patients with AKI', 'hospitalized patients with AKI', 'patients with acute kidney injury (AKI']","['Nicotinamide riboside (NR', 'NAD +  precursor vitamin and pterostilbene (PT', 'Nicotinamide riboside with pterostilbene (NRPT', 'combined NR and PT (NRPT', 'NRPT', 'placebo']","['Blood NAD +  levels', 'whole blood NAD +  levels', 'blood NAD +  levels', 'whole blood NAD +  levels and safety parameters', 'gastrointestinal side effects', 'safe and well tolerated', 'NAD +  levels', 'creatinine, estimated glomerular filtration rate (eGFR), electrolytes, liver function tests, and blood counts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}]","[{'cui': 'C0068711', 'cui_str': 'nicotinamide-beta-riboside'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0664965', 'cui_str': 'pterostilbene'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0027270', 'cui_str': 'Nicotinamide adenine dinucleotide (NAD)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0023901', 'cui_str': 'Hepatic function panel'}, {'cui': 'C0005771', 'cui_str': 'Blood cell count'}]",24.0,0.374567,"There was a trend for increase in NAD +  levels in all NRPT Steps individually at 48 h compared to 0 h, but only the change in Step 2 reached statistical significance (47%, p = 0.04), and there was considerable interindividual variability in the NAD +  response to treatment.","[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Simic', 'Affiliation': 'Division of Nephrology and Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. psimic@partners.org.'}, {'ForeName': 'Xavier Fernando', 'Initials': 'XF', 'LastName': 'Vela Parada', 'Affiliation': 'Division of Nephrology and Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Samir M', 'Initials': 'SM', 'LastName': 'Parikh', 'Affiliation': 'Division of Nephrology and Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Dellinger', 'Affiliation': 'Elysium Health Inc., New York, NY, USA.'}, {'ForeName': 'Leonard P', 'Initials': 'LP', 'LastName': 'Guarente', 'Affiliation': 'Elysium Health Inc., New York, NY, USA.'}, {'ForeName': 'Eugene P', 'Initials': 'EP', 'LastName': 'Rhee', 'Affiliation': 'Department of Biology, Massachusetts Institute of Technology, Cambridge, MA, USA.'}]",BMC nephrology,['10.1186/s12882-020-02006-1']
2082,32791985,"A monocentric, open-label randomized standard-of-care controlled study of XONRID®, a medical device for the prevention and treatment of radiation-induced dermatitis in breast and head and neck cancer patients.","BACKGROUND


This study was an open-label, 2-arms, monocentric, randomized clinical trial comparing Xonrid®, a topical medical device, versus standard of care (SOC) in preventing and treating acute radiation dermatitis (ARD) in Head and Neck Cancer (HNC) and Breast Cancer (BC) patients undergoing radiotherapy (RT).
METHODS


Eligible HNC and BC patients were randomized 1:1 to receive Xonrid® + SOC or SOC during RT. Patients were instructed to apply Xonrid® on the irradiated area three times daily, starting on the first day of RT and until 2 weeks after RT completion or until the development of grade ≥ 3 skin toxicity. The primary endpoint was to evaluate the proportion of patients who developed an ARD grade < 2 at the 5th week in both groups. Secondary endpoints were median time to grade 2 (G2) skin toxicity onset; changes in skin erythema and pigmentation and trans-epidermal water loss (TEWL); patient-reported skin symptoms. All patients were evaluated at baseline, weekly during RT and 2 weeks after treatment completion. The evaluation included: clinical toxicity assessment; reflectance spectrometry (RS) and TEWL examination; measurement of patients' quality of life (QoL) through Skindex-16 questionnaire.
RESULTS


Eighty patients (40 for each cancer site) were enrolled between June 2017 and July 2018. Groups were well balanced for population characteristics. All BC patients underwent 3-Dimensional Conformal RT (3D-CRT) whereas HNC patients underwent Volumetric-Modulated Arc Therapy (VMAT). At week 5 the proportion of BC patients who did not exhibit G2 ARD was higher in Xonrid® + SOC group (p = 0.091). In the same group the onset time of G2 ARD was significantly longer than in SOC-alone group (p < 0.0491). For HNC groups there was a similar trend, but it did not reach statistical significance. For both cancer sites, patients' QoL, measured by the Skindex-16 score, was always lower in the Xonrid® + SOC group.
CONCLUSION


Despite the failure to achieve the primary endpoint, this study suggests that Xonrid® may represent a valid medical device in the prevention and treatment of ARD at least in BC patients, delaying time to develop skin toxicity and reducing the proportion of patients who experienced G2 ARD during RT treatment and 2 weeks later.
TRIAL REGISTRATION


The study was approved by the Ethical Committee of Fondazione IRCCS Istituto Nazionale dei Tumori di Milano (INT 52/14 - NCT02261181 ). Registered on ClinicalTrial.gov on 21st August 2017.",2020,"For both cancer sites, patients' QoL, measured by the Skindex-16 score, was always lower in the Xonrid® + SOC group.
","['Eighty patients (40 for each cancer site) were enrolled between June 2017 and July 2018', 'breast and head and neck cancer patients', 'acute radiation dermatitis (ARD) in Head and Neck Cancer (HNC) and Breast Cancer (BC) patients undergoing radiotherapy (RT', 'Eligible HNC and BC patients']","['standard of care (SOC', 'HNC patients underwent Volumetric-Modulated Arc Therapy (VMAT', 'Xonrid®\u2009+\u2009SOC or SOC during RT', 'XONRID®', '3-Dimensional Conformal RT (3D-CRT']","['onset time of G2 ARD', 'G2 ARD', 'proportion of patients who developed an ARD grade\u2009<\u20092', ""clinical toxicity assessment; reflectance spectrometry (RS) and TEWL examination; measurement of patients' quality of life (QoL) through Skindex-16 questionnaire"", 'median time to grade 2 (G2) skin toxicity onset; changes in skin erythema and pigmentation and trans-epidermal water loss (TEWL); patient-reported skin symptoms', 'skin toxicity']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0263606', 'cui_str': 'Early radiation dermatitis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0600521', 'cui_str': 'Conformal radiotherapy'}, {'cui': 'C0026377', 'cui_str': 'Molecular conformation'}]","[{'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0263606', 'cui_str': 'Early radiation dermatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0436196', 'cui_str': 'Spectrometry'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1167791', 'cui_str': 'Skin toxicity'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0586407', 'cui_str': 'Skin symptom'}]",,0.0445439,"For both cancer sites, patients' QoL, measured by the Skindex-16 score, was always lower in the Xonrid® + SOC group.
","[{'ForeName': 'Rossana', 'Initials': 'R', 'LastName': 'Ingargiola', 'Affiliation': 'Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Maria Carmen', 'Initials': 'MC', 'LastName': 'De Santis', 'Affiliation': 'Radiation Oncology Unit 1, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Nicola Alessandro', 'Initials': 'NA', 'LastName': 'Iacovelli', 'Affiliation': 'Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy. nicolaalessandro.iacovelli@istitutotumori.mi.it.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Facchinetti', 'Affiliation': 'Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Cavallo', 'Affiliation': 'Medical Physics Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Ivaldi', 'Affiliation': 'Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Dispinzieri', 'Affiliation': 'Radiation Oncology Unit 1, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Marzia', 'Initials': 'M', 'LastName': 'Franceschini', 'Affiliation': 'Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Giandini', 'Affiliation': 'Radiation Oncology Unit 1, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Domenico Attilio', 'Initials': 'DA', 'LastName': 'Romanello', 'Affiliation': 'Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Di Biaso', 'Affiliation': 'Medical Physics Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Sabetti', 'Affiliation': 'Medical Physics Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Locati', 'Affiliation': 'Head and Neck Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Alfieri', 'Affiliation': 'Head and Neck Medical Oncology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bossi', 'Affiliation': 'Medical Oncology, University of Brescia, ASST-Spedali Civili, Brescia, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Guglielmo', 'Affiliation': 'Oncology-Supportive Care Unit, Fondazione IRCCS, Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Macchi', 'Affiliation': 'Helsinn Healthcare SA, Lugano, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lozza', 'Affiliation': 'Radiation Oncology Unit 1, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Valdagni', 'Affiliation': 'Radiation Oncology Unit 1, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Fallai', 'Affiliation': 'Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Pignoli', 'Affiliation': 'Medical Physics Unit, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Orlandi', 'Affiliation': 'Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133, Milan, Italy.'}]","Radiation oncology (London, England)",['10.1186/s13014-020-01633-0']
2083,32792403,Building social cohesion between Christians and Muslims through soccer in post-ISIS Iraq.,"Can intergroup contact build social cohesion after war? I randomly assigned Iraqi Christians displaced by the Islamic State of Iraq and Syria (ISIS) to an all-Christian soccer team or to a team mixed with Muslims. The intervention improved behaviors toward Muslim peers: Christians with Muslim teammates were more likely to vote for a Muslim (not on their team) to receive a sportsmanship award, register for a mixed team next season, and train with Muslims 6 months after the intervention. The intervention did not substantially affect behaviors in other social contexts, such as patronizing a restaurant in Muslim-dominated Mosul or attending a mixed social event, nor did it yield consistent effects on intergroup attitudes. Although contact can build tolerant behaviors toward peers within an intervention, building broader social cohesion outside of it is more challenging.",2020,"The intervention improved behaviors toward Muslim peers: Christians with Muslim teammates were more likely to vote for a Muslim (not on their team) to receive a sportsmanship award, register for a mixed team next season, and train with Muslims 6 months after the intervention.",[],['Iraqi Christians displaced by the Islamic State of Iraq and Syria (ISIS) to an all-Christian soccer team or to a team mixed with Muslims'],[],[],"[{'cui': 'C1556087', 'cui_str': 'Iraqi'}, {'cui': 'C0008532', 'cui_str': 'Christian religion'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0022066', 'cui_str': 'Iraq'}, {'cui': 'C0039138', 'cui_str': 'Syria'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}]",[],,0.027518,"The intervention improved behaviors toward Muslim peers: Christians with Muslim teammates were more likely to vote for a Muslim (not on their team) to receive a sportsmanship award, register for a mixed team next season, and train with Muslims 6 months after the intervention.","[{'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Mousa', 'Affiliation': 'Stanford University, Palo Alto, CA 94305, USA.'}]","Science (New York, N.Y.)",['10.1126/science.abb3153']
2084,32792711,A randomised study comparing the extent of block produced by spinal column height and body weight-based formulae for paediatric caudal analgesia.,"Background and Aims


Height and weight-based formulae are used for calculation of dose of medications for caudal analgesia but these have not been compared. We compared spinal column height-based Spiegel and weight-based Takasaki and Armitage formulae for achieving maximum height of sensory neuraxial block after caudal epidural analgesia in paediatric patients.
Methods


In this double-blind randomised study, children aged between 1 and 6 years and planned for infra-umbilical surgery were randomly allocated to receive caudal epidural block (targeting T 10 level block) with 0.25% bupivacaine, using a volume calculated by modified Spiegel formula (group I), Takasaki formula (group II), and Armitage formula (group III). The Institute ethics committee reviewed and approved the study protocol. The primary endpoint of the study was the difference in the number of spinal segments blocked as assessed by pinprick method. The secondary endpoint was the difference in volume of 0.25% bupivacaine used among the groups. The groups were compared using one-way ANOVA.
Results


Seventy-five patients (25 in each group) completed the study as per protocol. The mean number of spinal segments blocked was significantly different among groups ( P  < 0.001) with patients in group I (13.8 ± 0.83) showing significantly lower number of spinal segments blocked as compared to that in group II (15.8 ± 1.06;  P  < 0.001), and group III (16.8 ± 1.28;  P  < 0.001). The mean volume of 0.25% bupivacaine used in group I was significantly lower ( P  < 0.001) than that in group II and group III.
Conclusion


Dose calculation in caudal epidural analgesia as per spinal column height-based modified Spiegel formula was more precise than bodyweight-based Takasaki and Armitage formulae.",2020,"The mean volume of 0.25% bupivacaine used in group I was significantly lower ( P  < 0.001) than that in group II and group III.
","['paediatric patients', 'children aged between 1 and 6 years and planned for infra-umbilical surgery']","['caudal epidural block (targeting T 10 level block) with 0.25% bupivacaine, using a volume calculated by modified Spiegel formula (group I), Takasaki formula', 'spinal column height-based Spiegel and weight-based Takasaki and Armitage formulae', 'bupivacaine']","['mean volume', 'mean number of spinal segments blocked', 'number of spinal segments', 'number of spinal segments blocked as assessed by pinprick method']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0041638', 'cui_str': 'Umbilical structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0394837', 'cui_str': 'Local anesthetic sacral epidural block'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",75.0,0.0502598,"The mean volume of 0.25% bupivacaine used in group I was significantly lower ( P  < 0.001) than that in group II and group III.
","[{'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Kaushal', 'Affiliation': 'Department of Anaesthesiology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India.'}, {'ForeName': 'Surinder', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Anaesthesiology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Department of Anaesthesiology, Indira Gandhi Medical College, Shimla, Himachal Pradesh, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_824_19']
2085,32792712,Multipoint transcutaneous electrical stimulation reduces median effective plasma concentration of propofol: A randomised clinical trial.,"Background and Aims


Previous work shows that transcutaneous electrical stimulation (TES) has analgesic and sedative effects. However, it is unclear whether TES can affect the sedative effect of propofol or not. This study was designed to assess the effect of TES on median effective plasma concentration (Cp50) of propofol and haemodynamic changes before and after tracheal intubation.
Methods


48 patients belonging to ASA I or II posted for thyroidectomy were randomly allocated into control and TES groups. Up-and-down method was used to determine Cp50 of propofol. The average concentration of propofol in each crossover was calculated and the average concentration of those six values was defined as Cp50 of propofol.
Results


Cp50 of propofol was 3.70 ± 0.28 μg/mL and 3.08 ± 0.31 μg/mL in control and TES groups, respectively ( P  < 0.05). There were no significant differences in MAP (90.3 ± 12.4 mmHg vs. 97.0 ± 10.8 mmHg, 94.2 ± 18.7 mmHg vs. 98.3 ± 16.6 mmHg and 84.9 ± 14.1 mmHg vs. 91.6 ± 16.2 mmHg) and HR (78.2 ± 11.3 b/min vs. 75.6 ± 9.5 b/min, 90.9 ± 15.4 b/min vs. 90.4 ± 14.9 b/min and 86.7 ± 13.7 b/min vs. 84.0 ± 15.9 b/min) at T0, T1 and T2 between two groups. In TES group, HR changes at T1 and T2 were significantly higher than those at T0.
Conclusion


TES can make an assistant effect on sedation and decrease Cp50 of propofol. But the haemodynamic fluctuations in TES group, especially the HR changes, seem to be more obvious than those in control group.",2020,"There were no significant differences in MAP (90.3 ± 12.4 mmHg vs. 97.0 ± 10.8 mmHg, 94.2 ± 18.7 mmHg vs. 98.3 ± 16.6 mmHg and 84.9 ± 14.1 mmHg vs. 91.6 ± 16.2 mmHg) and HR (78.2 ± 11.3 b/min vs. 75.6 ± 9.5 b/min, 90.9 ± 15.4 b/min vs. 90.4 ± 14.9 b/min and 86.7 ± 13.7 b/min vs. 84.0 ± 15.9 b/min) at T0, T1 and T2 between two groups.",['48 patients belonging to ASA I or II posted for thyroidectomy'],"['TES', 'propofol', 'transcutaneous electrical stimulation (TES', 'Multipoint transcutaneous electrical stimulation']","['sedative effect', 'HR changes', 'median effective plasma concentration (Cp50', 'average concentration of propofol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C3179159', 'cui_str': 'Sedative Effects'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]",48.0,0.022465,"There were no significant differences in MAP (90.3 ± 12.4 mmHg vs. 97.0 ± 10.8 mmHg, 94.2 ± 18.7 mmHg vs. 98.3 ± 16.6 mmHg and 84.9 ± 14.1 mmHg vs. 91.6 ± 16.2 mmHg) and HR (78.2 ± 11.3 b/min vs. 75.6 ± 9.5 b/min, 90.9 ± 15.4 b/min vs. 90.4 ± 14.9 b/min and 86.7 ± 13.7 b/min vs. 84.0 ± 15.9 b/min) at T0, T1 and T2 between two groups.","[{'ForeName': 'Zhang', 'Initials': 'Z', 'LastName': 'Jing', 'Affiliation': ""Department of Anaesthesiology, Peking University People's Hospital (Beijing Cancer Hospital), Beijing, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Ling', 'Affiliation': ""Department of Anaesthesiology, Peking University People's Hospital (Beijing Cancer Hospital), Beijing, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Yi', 'Affiliation': ""Department of Anaesthesiology, Peking University People's Hospital (Beijing Cancer Hospital), Beijing, China.""}]",Indian journal of anaesthesia,['10.4103/ija.IJA_775_19']
2086,32792716,Comparison of transversus abdominis plane block and intrathecal morphine for laparoscopic donor nephrectomy: Randomised controlled trial.,"Background and Aims


Postoperative pain following laparoscopic donor nephrectomy (LDN) is significant and no suitable analgesic technique is described. Opioid analgesia in standard doses is often suboptimal and associated with numerous adverse effects. Transversus abdominis plane (TAP) block has been evaluated in various laparoscopic procedures. Intrathecal morphine (ITM) has been seen to provide long-lasting analgesia of superior quality in laparoscopic colorectal procedures.
Methods


The present study was undertaken to evaluate the analgesic efficacy of single-dose ITM 5 μg/kg for LDN. After ethics approval, 60 adult patients scheduled for LDN were randomised to receive intravenous fentanyl, ultrasound-guided TAP block or ITM for postoperative analgesia. Postoperative 24-h patient-controlled analgesia (PCA) fentanyl consumption, visual analogue scale (VAS) score and intraoperative fentanyl and muscle relaxant requirements were compared. Statistical analysis was performed using appropriate statistical tests by using Stata 11.1 software.
Results


Haemodynamic stability at pneumoperitoneum and in the post anaesthesia care unit was significantly better in patients receiving ITM. Intraoperative rescue fentanyl requirement ( P  = 0.01) and postoperative fentanyl requirement until 24 h ( P  = 0.000) were significantly lower in the morphine group. Postoperative VAS at rest and on movement was significantly lower in the morphine group at all points of assessment ( P  = 0.000).
Conclusion


ITM 5 μg/kg provides better intraoperative and postoperative analgesia and reduces postoperative PCA fentanyl requirement in laparoscopic donor nephrectomy compared to TAP block or intravenous fentanyl.",2020,"Postoperative VAS at rest and on movement was significantly lower in the morphine group at all points of assessment ( P  = 0.000).
","['laparoscopic donor nephrectomy', '60 adult patients scheduled for LDN']","['Opioid analgesia', 'laparoscopic donor nephrectomy', 'Intrathecal morphine (ITM', 'Transversus abdominis plane (TAP) block', 'TAP block or intravenous fentanyl', 'laparoscopic donor nephrectomy (LDN', 'transversus abdominis plane block and intrathecal morphine', 'intravenous fentanyl, ultrasound-guided TAP block or ITM', 'morphine']","['Postoperative 24-h patient-controlled analgesia (PCA) fentanyl consumption, visual analogue scale (VAS) score and intraoperative fentanyl and muscle relaxant requirements', 'Haemodynamic stability', 'analgesic efficacy', 'Postoperative VAS at rest and on movement', 'postoperative PCA fentanyl requirement', 'Intraoperative rescue fentanyl requirement', 'postoperative fentanyl requirement']","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0411257', 'cui_str': 'Donor nephrectomy'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0026827', 'cui_str': 'Decreased muscle tone'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",60.0,0.21334,"Postoperative VAS at rest and on movement was significantly lower in the morphine group at all points of assessment ( P  = 0.000).
","[{'ForeName': 'Sathianarayanan', 'Initials': 'S', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, New Delhi, India.'}, {'ForeName': 'Rajeshwari', 'Initials': 'R', 'LastName': 'Subramaniam', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, New Delhi, India.'}, {'ForeName': 'Anjolie', 'Initials': 'A', 'LastName': 'Chhabra', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, New Delhi, India.'}, {'ForeName': 'Dalim K', 'Initials': 'DK', 'LastName': 'Baidya', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, New Delhi, India.'}, {'ForeName': 'Mahesh K', 'Initials': 'MK', 'LastName': 'Arora', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, New Delhi, India.'}, {'ForeName': 'Souvik', 'Initials': 'S', 'LastName': 'Maitra', 'Affiliation': 'Department of Anesthesiology, Pain Medicine and Critical Care, New Delhi, India.'}, {'ForeName': 'Virender K', 'Initials': 'VK', 'LastName': 'Bansal', 'Affiliation': 'Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Hemanga K', 'Initials': 'HK', 'LastName': 'Bhattacharjee', 'Affiliation': 'Surgical Disciplines, All India Institute of Medical Sciences, New Delhi, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_868_19']
2087,32792736,Effect of liberal versus restrictive fluid therapy on intraoperative lactate levels in robot- assisted colorectal surgery.,"Background and Aims


Minimally invasive and robotic surgeries need lesser fluid replacement but the role of restricted fluids in robotic surgeries other than prostatic surgeries has not been clearly defined. Our primary aim was to evaluate the effects of a restrictive fluid regimen versus a liberal policy on intra-operative lactate in robotic colorectal surgery. Secondary outcomes were need for vasopressors, extubation on table, post-operative renal functions and length of ICU (LOICU) stay.
Methods


American society of anaesthesiologists (ASA) physical status I-II patients scheduled for robot-assisted colorectal surgery were randomised into one of two groups, receiving either 2 mL/kg/h (Group R) or 4mL/kg/h, (group L). Fluid boluses of 250 ml were administered if mean arterial pressure (MAP) <65 mmHg or urine output <0.5 ml/kg/h. Norepinephrine was added for the blood pressure after 2 fluid boluses. Surgical field was assessed by modified Boezaart's scale and surgeon satisfaction by Likert scale.
Results


Demographics and baseline renal functions were comparable. Adjusted intra-operative lactate at 2 h, 4 h, and 6 h and need for noradrenaline and post-operative creatinine were similar. One patient in the group L was ventilated due to hypothermia. The field was better at the 4 h in group R and comparable at other time points. The LOICU stay was longer in Group L.
Conclusion


The use of restrictive fluid strategy of 2 mL/kg/h (group R) does not increase lactate levels or creatinine, improves surgical field at 4 h and shortens ICU stay in comparison to a liberal 4 mL/kg/h (group L) in robotic colorectal surgery.",2020,"The use of restrictive fluid strategy of 2 mL/kg/h (group R) does not increase lactate levels or creatinine, improves surgical field at 4 h and shortens ICU stay in comparison to a liberal 4 mL/kg/h (group L) in robotic colorectal surgery.","['Methods\n\n\nAmerican society of anaesthesiologists (ASA) physical status', 'robot- assisted colorectal surgery', 'robotic colorectal surgery']","['I-II patients scheduled for robot-assisted colorectal surgery', 'Norepinephrine', 'restrictive fluid regimen', 'liberal versus restrictive fluid therapy']","['blood pressure', 'LOICU stay', 'Adjusted intra-operative lactate at 2 h, 4 h, and 6 h and need for noradrenaline and post-operative creatinine', 'lactate levels or creatinine, improves surgical field at 4 h and shortens ICU stay', 'intraoperative lactate levels', 'need for vasopressors, extubation on table, post-operative renal functions and length of ICU (LOICU) stay']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}]","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0016286', 'cui_str': 'Therapy, Fluid'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0039224', 'cui_str': 'Table'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",250.0,0.184313,"The use of restrictive fluid strategy of 2 mL/kg/h (group R) does not increase lactate levels or creatinine, improves surgical field at 4 h and shortens ICU stay in comparison to a liberal 4 mL/kg/h (group L) in robotic colorectal surgery.","[{'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiology, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Kalyan', 'Initials': 'K', 'LastName': 'Kumar', 'Affiliation': 'Department of Anaesthesiology, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Sai', 'Initials': 'S', 'LastName': 'Sandhya', 'Affiliation': 'Department of Anaesthesiology, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Deepa M', 'Initials': 'DM', 'LastName': 'Koshy', 'Affiliation': 'Department of Anaesthesiology, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Kruthika P', 'Initials': 'KP', 'LastName': 'Ramamurthi', 'Affiliation': 'Department of Anaesthesiology, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Rajan', 'Affiliation': 'Department of Anaesthesiology, Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India.'}]",Indian journal of anaesthesia,['10.4103/ija.IJA_401_20']
2088,32803641,"Central Sleep Apnea in Patients with Heart Failure-How to Screen, How to Treat.","PURPOSE OF REVIEW


Central sleep apnea occurs in up to 50% of heart failure patients and worsens outcomes. Established therapies are limited by minimal supporting evidence, poor patient adherence, and potentially adverse cardiovascular effects. However, transvenous phrenic nerve stimulation, by contracting the diaphragm, restores normal breathing throughout sleep and has been shown to be safe and effective. This review discusses the mechanisms, screening, diagnosis, and therapeutic approaches to CSA in patients with HF.
RECENT FINDINGS


In a prospective, multicenter randomized Pivotal Trial (NCT01816776) of transvenous phrenic nerve stimulation with the remedē System, significantly more treated patients had a ≥ 50% reduction in apnea-hypopnea index compared with controls, with a 41 percentage point difference between group difference at 6 months (p < 0.0001). All hierarchically tested sleep, quality of life, and daytime sleepiness endpoints were significantly improved in treated patients. Freedom from serious related adverse events at 12 months was 91%. Benefits are sustained to 36 months. Transvenous phrenic nerve stimulation improves quality of life in patients with heart failure and central sleep apnea. Controlled trials evaluating the impact of this therapy on mortality/heart failure hospitalizations and ""real world"" experience are needed to confirm safety and effectiveness.",2020,"All hierarchically tested sleep, quality of life, and daytime sleepiness endpoints were significantly improved in treated patients.","['patients with HF', 'Patients with Heart Failure', 'patients with heart failure and central sleep apnea']","['Transvenous phrenic nerve stimulation', 'transvenous phrenic nerve stimulation']","['quality of life', 'Central Sleep Apnea', 'sleep, quality of life, and daytime sleepiness endpoints', 'apnea-hypopnea index']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}]","[{'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0520680', 'cui_str': 'Apnea, Central Sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}]",,0.0357139,"All hierarchically tested sleep, quality of life, and daytime sleepiness endpoints were significantly improved in treated patients.","[{'ForeName': 'Maria Rosa', 'Initials': 'MR', 'LastName': 'Costanzo', 'Affiliation': 'Heart Failure Research, Advocate Heart Institute, Naperville, IL, USA. mariarosa.costanzo@advocatehealth.com.'}]",Current heart failure reports,['10.1007/s11897-020-00472-0']
2089,32803669,Lenalidomide: A Review in Previously Treated Follicular Lymphoma.,"Lenalidomide (Revlimid ® ) is a targeted immunomodulatory drug with multiple mechanisms of action. In the USA and the EU, oral lenalidomide is indicated in combination with rituximab or a rituximab product for the treatment of patients with previously treated follicular lymphoma. In the pivotal, phase III AUGMENT trial, lenalidomide + rituximab significantly prolonged progression-free survival (PFS; primary endpoint) relative to placebo + rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma, with the PFS benefit appearing to be specific to patients with follicular lymphoma and extending to elderly patients with this subtype. Lenalidomide + rituximab also demonstrated activity in an interim analysis of the phase III MAGNIFY trial in patients with relapsed or refractory indolent non-Hodgkin lymphoma, including those with rituximab-refractory disease. Lenalidomide had an acceptable tolerability profile. Although grade 3 or 4 neutropenia occurred more frequently with lenalidomide + rituximab than with placebo + rituximab, this was generally well managed with dosage adjustments and growth factor support. In conclusion, lenalidomide in combination with rituximab represents an important new treatment option for previously treated follicular lymphoma, including patients whose disease has become refractory to rituximab.",2020,"Although grade 3 or 4 neutropenia occurred more frequently with lenalidomide + rituximab than with placebo + rituximab, this was generally well managed with dosage adjustments and growth factor support.","['patients with relapsed or refractory indolent non-Hodgkin lymphoma, including those with rituximab-refractory disease', 'patients with previously treated follicular lymphoma', 'patients with relapsed or refractory indolent non-Hodgkin lymphoma']","['placebo + rituximab', 'Lenalidomide', 'lenalidomide + rituximab', 'Lenalidomide (Revlimid ® ', 'rituximab', 'Lenalidomide + rituximab']","['acceptable tolerability profile', 'neutropenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0024305', 'cui_str': 'Malignant lymphoma, non-Hodgkin'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C1135145', 'cui_str': 'Revimid'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",,0.0292288,"Although grade 3 or 4 neutropenia occurred more frequently with lenalidomide + rituximab than with placebo + rituximab, this was generally well managed with dosage adjustments and growth factor support.","[{'ForeName': 'Hannah A', 'Initials': 'HA', 'LastName': 'Blair', 'Affiliation': 'Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.'}]",Drugs,['10.1007/s40265-020-01381-1']
2090,32803700,Phase I/II study of erlotinib plus S-1 for patients with previously treated non-small cell lung cancer: Thoracic Oncology Research Group (TORG) 0808/0913.,"Introduction In preclinical data, the combination therapy with S-1 and epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) had a synergistic antitumor effect on non-small cell lung cancer (NSCLC), regardless of the EGFR mutation status. Patients and Methods Patients with previously treated NSCLC and adequate organ function regardless of EGFR mutation status were eligible for the phase I study, with wild-type EGFR were eligible for the phase II study. Treatment consisted of erlotinib 150 mg/body orally once every day and S-1 60 mg/m 2 , 70 mg/m 2 , or 80 mg/m 2  (level 0, level 1, or level 2) orally on days 1-14 every three weeks. The primary endpoint for the phase I study was the determination of the recommended dose (RD), the phase II study was the overall response rate (ORR). Results A total of 7 patients with performance-status (PS) 0 or 1 were enrolled as subjects in phase I. Five of these subjects were EGFR-mutation positive. Four subjects were enrolled at S-1 dose level 1 and 3 were enrolled at S-1 dose level 2. No dose-limiting toxicities were observed in these subjects. The RD was decided as erlotinib 150 mg/body and S-1 80 mg/m 2 . In phase I, 5 subjects achieved partial response, and the ORR was 71.4%. A total of 10 patients with PS 0, 1, or 2 EGFR-wild type NSCLC were enrolled in phase II. In phase II, the ORR was 10.0%, and the disease control rate (DCR) was 40.0%. After the enrollment of 10 subjects, enrollment was stopped based on two treatment-related deaths. Conclusion The combination therapy of erlotinib plus S-1 was not feasible in the EGFR wild-type NSCLC at least and early stopped. Trial registration: UMIN-CTR Identifier: 000003421 (2010/03/31, phase I), 000003422 (2010/03/31, Phase II).",2020,No dose-limiting toxicities were observed in these subjects.,"['10 patients with PS 0, 1, or 2 EGFR-wild type NSCLC were enrolled in phase II', '7 patients with performance-status (PS) 0 or 1 were enrolled as subjects in phase I. Five of these subjects were EGFR-mutation positive', 'patients with previously treated non-small cell lung cancer: Thoracic Oncology Research Group (TORG', 'Patients and Methods Patients with previously treated NSCLC and adequate organ function regardless of EGFR mutation status were eligible for the phase I study, with wild-type EGFR were eligible for the phase II study', 'Four subjects were enrolled at S-1 dose level 1 and 3 were enrolled at S-1 dose level 2']","['S-1 and epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor ', 'erlotinib 150\xa0mg/body and S-1 80\xa0mg', 'erlotinib plus S-1', 'erlotinib 150\xa0mg/body orally once every day and S-1 60']","['overall response rate (ORR', 'synergistic antitumor effect', 'ORR', 'partial response', 'determination of the recommended dose (RD', 'No dose-limiting toxicities', 'disease control rate (DCR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0920321', 'cui_str': 'Phase I Clinical Trials'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C1628394', 'cui_str': 'erlotinib 150 MG'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}]",7.0,0.0262697,No dose-limiting toxicities were observed in these subjects.,"[{'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Nakahara', 'Affiliation': 'Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, 3-18-22, Honkomagome, Bunkyo-ku, Tokyo, 113-8677, Japan. md100062@kcch.jp.'}, {'ForeName': 'Tsuneo', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': ""Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa, 240-8555, Japan.""}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Misumi', 'Affiliation': ""Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa, 240-8555, Japan.""}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Nogami', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, 160 Kou Minami-Umemoto, Matsuyama, Ehime, 791-0280, Japan.'}, {'ForeName': 'Tetsu', 'Initials': 'T', 'LastName': 'Shinkai', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Shikoku Cancer Center, 160 Kou Minami-Umemoto, Matsuyama, Ehime, 791-0280, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Seki', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, 2-11-1, Kaga, Itabashi-ku, Tokyo, 173-0014, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Hosomi', 'Affiliation': 'Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital, 3-18-22, Honkomagome, Bunkyo-ku, Tokyo, 113-8677, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Hida', 'Affiliation': ""Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa, 240-8555, Japan.""}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': ""Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, 56 Okazawa-cho, Hodogaya-ku, Yokohama, Kanagawa, 240-8555, Japan.""}]",Investigational new drugs,['10.1007/s10637-020-00985-4']
2091,32803709,"The Metabolic Effects of Pre-probiotic Supplementation After Roux-en-Y Gastric Bypass (RYGB) Surgery: a Prospective, Randomized Controlled Study.","PURPOSE


Following Roux-en-Y gastric bypass (RYGB), positive alterations are observed in gut microbiota and intestinal peptides. Previous studies demonstrated similar alterations observed in cases when pre-probiotics are used without surgery. The aim of this trial was to evaluate the effectiveness of early use of pre-probiotics after RYGB.
MATERIAL AND METHODS


The operation and follow-up of the patients were performed at Istanbul University Medical Faculty. Thirty-two patients who had undergone RYGB were randomized to pre-probiotic group (PreProBG, n = 16; 200 g/day yogurt plus 10 g/day inulin+oligofructose) and probiotic group (ProBG, n = 16; 200 g/day yogurt only) for 6 months. Blood samples (glucose, insulin, A1c, GLP-1, PYY), anthropometric measurements, and appetite ratings have been evaluated at baseline and 3 (m3) and 6 (m6) months after RYGB.
RESULTS


Initial anthropometric measurements and appetite ratings decreased significantly after surgery and there were no significant differences between the groups. The decrease of area under the curve(insulin) was less and has a positive correlation with the changes in anthropometric measurements in PreProBG. GLP-1 and PYY which increased dramatically after surgery in all patients were higher in PreProBG. But this increase had a negative correlation with the changes in anthropometric measurements during the study.
CONCLUSION


Increased insulin, GLP-1, and PYY secretion was more enhanced by pre-probiotic use in early postoperative period. But this increase not only in anthropometric measurements but also in appetite ratings affects negatively, contrary to expectations. In summary, it should be investigated with new studies that use of pre-probiotics in the late postoperative period may be more effective in patients with weak insulin and incretin response and therefore insufficient weight loss. Trial Registration clinicaltrials.gov Identifier: NCT03517345.",2020,The decrease of area under the curve(insulin) was less and has a positive correlation with the changes in anthropometric measurements in PreProBG.,"['The operation and follow-up of the patients were performed at Istanbul University Medical Faculty', 'Thirty-two patients who had undergone RYGB']","['Pre-probiotic Supplementation After Roux-en-Y Gastric Bypass (RYGB', 'pre-probiotic group (PreProBG, n\u2009=\u200916; 200\xa0g/day yogurt plus 10\xa0g/day inulin+oligofructose) and probiotic group (ProBG', 'Roux-en-Y gastric bypass (RYGB']","['insulin, GLP-1, and PYY secretion', 'Initial anthropometric measurements and appetite ratings', 'Blood samples (glucose, insulin, A1c, GLP-1, PYY), anthropometric measurements, and appetite ratings', 'decrease of area under the curve(insulin']","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0015537', 'cui_str': 'Faculties, Medical'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",,0.0438943,The decrease of area under the curve(insulin) was less and has a positive correlation with the changes in anthropometric measurements in PreProBG.,"[{'ForeName': 'Fulya', 'Initials': 'F', 'LastName': 'Calikoglu', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Metabolism, Istanbul Faculty of Medicine, University of Istanbul, Istanbul, Turkey. bfulyacalikoglu@gmail.com.'}, {'ForeName': 'Umut', 'Initials': 'U', 'LastName': 'Barbaros', 'Affiliation': 'Department of General Surgery, Istanbul Faculty of Medicine, University of Istanbul, Istanbul, Turkey.'}, {'ForeName': 'Ayse Kubat', 'Initials': 'AK', 'LastName': 'Uzum', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Metabolism, Istanbul Faculty of Medicine, University of Istanbul, Istanbul, Turkey.'}, {'ForeName': 'Yildiz', 'Initials': 'Y', 'LastName': 'Tutuncu', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Metabolism, Istanbul Faculty of Medicine, University of Istanbul, Istanbul, Turkey.'}, {'ForeName': 'Ilhan', 'Initials': 'I', 'LastName': 'Satman', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology and Metabolism, Istanbul Faculty of Medicine, University of Istanbul, Istanbul, Turkey.'}]",Obesity surgery,['10.1007/s11695-020-04894-6']
2092,32803900,Effect of once-weekly exenatide on eGFR slope depends on baseline renal risk: a post-hoc analysis of the EXSCEL trial.,"The effects of glucagon-like peptide-1 receptor agonists (GLP-1 RA) on renal outcomes in patients with type 2 diabetes at high cardiovascular (CV) risk are modest or neutral. However, GLP-1 RA may confer clinical benefits in those at high risk of progressive renal function loss. We examined effects of once-weekly exenatide (EQW) on eGFR slope and urinary albumin:creatinine ratio (UACR) as a function of baseline UACR in 3503 (23.7%) EXSCEL participants with eGFR data available and 2828 (19.2%) participants with UACR change data available. EQW improved eGFR slope assessed via mixed model repeated measures (MMRM), compared with placebo, in participants with baseline UACR>100 mg/g (0.79 mL/min/1.73 m2/year [95% CI 0.24-1.34]) and UACR>200 mg/g (1.32 mL/min/1.73 m2/year 95% CI [0.57-2.06]), but not at lower UACR thresholds. EQW reduced UACR, compared with placebo, assessed via ANCOVA consistently across subgroups with baseline UACR>30 mg/g (28.2% reduction), baseline UACR>100 mg (22.5% reduction) and baseline UACR>200 mg (34.5% reduction). This post-hoc EXSCEL analysis suggests that EQW reduces UACR, with improvement in eGFR slope specifically in participants with elevated baseline UACR. This article is protected by copyright. All rights reserved.",2020,"EQW reduced UACR, compared with placebo, assessed via ANCOVA consistently across subgroups with baseline UACR>30 mg/g (28.2% reduction), baseline UACR>100 ","['patients with type 2 diabetes at high cardiovascular (CV) risk', '3503 (23.7%) EXSCEL participants with eGFR data available and 2828 (19.2%) participants with UACR change data available', 'participants with baseline UACR>100', 'participants with elevated baseline UACR']","['exenatide', 'GLP-1 RA', 'exenatide (EQW', 'glucagon-like peptide-1 receptor agonists (GLP-1 RA', 'placebo']","['baseline UACR>200', 'baseline renal risk', 'eGFR slope and urinary albumin:creatinine ratio (UACR', 'baseline UACR>100', 'EQW reduced UACR', 'EQW improved eGFR slope', 'eGFR slope']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.427864,"EQW reduced UACR, compared with placebo, assessed via ANCOVA consistently across subgroups with baseline UACR>30 mg/g (28.2% reduction), baseline UACR>100 ","[{'ForeName': 'Annemarie B van der', 'Initials': 'ABV', 'LastName': 'Aart-van der Beek', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Lindsay E', 'Initials': 'LE', 'LastName': 'Clegg', 'Affiliation': 'Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Penland', 'Affiliation': 'Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Boston, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boulton', 'Affiliation': 'Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'Late-stage Development CVRM, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mentz', 'Affiliation': 'Duke University and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Clinical Pharmacy and Pharmacology, University of Groningen, Groningen, Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14175']
2093,32804002,Feasibility of Clinical Hypnosis for Test Anxiety in First-Year Medical Students.,"The purpose of this pilot study was to characterize test anxiety among first-year medical students at the University of Erlangen-Nürnberg and to test clinical hypnosis as a possible intervention. The ""Prüfungsangstfragebogen,"" a shortened and revised German version of the Test Anxiety Inventory, was used to estimate test anxiety. It was administered 3 times: at the commencement of winter term 2017/18 and 2 days prior to each of 2 mandatory oral anatomy exams. The test-anxiety categories emotionality, worry, interference, and lack of confidence were evaluated. The effect of clinical hypnosis on test anxiety was estimated. The global test anxiety and lack of confidence scores were reduced significantly over time in the group that underwent clinical hypnosis but not in the control group. Direct comparisons of hypnosis vs. control group yielded no statistically significant differences in the test anxiety scores.",2020,The global test anxiety and lack of confidence scores were reduced significantly over time in the group that underwent clinical hypnosis but not in the control group.,"['First-Year Medical Students', 'first-year medical students at the University of Erlangen-Nürnberg and to test clinical hypnosis as a possible intervention']","['clinical hypnosis', 'Clinical Hypnosis']","['global test anxiety and lack of confidence scores', 'test anxiety', 'test anxiety scores', 'test-anxiety categories emotionality, worry, interference, and lack of confidence']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0558092', 'cui_str': 'Lacks confidence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0542317', 'cui_str': 'Character trait finding of affective stability'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}]",,0.0225398,The global test anxiety and lack of confidence scores were reduced significantly over time in the group that underwent clinical hypnosis but not in the control group.,"[{'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Hammer', 'Affiliation': 'Department of Functional and Clinical Anatomy, Friedrich-Alexander University of Erlangen-Nürnberg , Bavaria, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Scholz', 'Affiliation': 'Department of Functional and Clinical Anatomy, Friedrich-Alexander University of Erlangen-Nürnberg , Bavaria, Germany.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Bischofsberger', 'Affiliation': 'Department of Functional and Clinical Anatomy, Friedrich-Alexander University of Erlangen-Nürnberg , Bavaria, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Paulsen', 'Affiliation': 'Department of Functional and Clinical Anatomy, Friedrich-Alexander University of Erlangen-Nürnberg , Bavaria, Germany.'}, {'ForeName': 'Pascal H M', 'Initials': 'PHM', 'LastName': 'Burger', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry Zurich , Switzerland.'}]",The International journal of clinical and experimental hypnosis,['10.1080/00207144.2020.1799379']
2094,32804069,Developing a cognitive behavioral therapy for hypersomnia using telehealth: a feasibility study.,"STUDY OBJECTIVES


The purpose of this study was to evaluate the feasibility and acceptability of a novel cognitive behavioral therapy for hypersomnia (CBT-H) in people with central disorders of hypersomnolence (CDH) and co-occurring depressive symptoms using a telehealth model for delivery and assessment.
METHODS


35 adults with narcolepsy or idiopathic hypersomnia received a 6-session CBT-H delivered individually or in small groups using videoconferencing. The clinical impact of CBT-H was evaluated using the Patient Health Questionnaire (PHQ-8), Patient-Reported Outcomes Measurement Information System (PROMIS) measures, Epworth Sleepiness Scale (ESS), and other patient-reported outcomes collected online at baseline and post-treatment. Feasibility and acceptability of the intervention and telehealth model was also evaluated using qualitative data collected from exit interviews conducted through videoconferencing.
RESULTS


40% of the sample achieved a clinically significant baseline to post-treatment change in depressive symptoms (decrease in PHQ-8 ≥ 5), which is below the pre-specified efficacy benchmark (50% of the sample). The pre-specified benchmark for a minimal clinically important difference (Cohen's d >0.5) on other psychosocial measures was met only on the PROMIS global self-efficacy (d=0.62) in the total sample. Qualitative data revealed enthusiasm for the accessibility of telehealth delivery and the usefulness of several cognitive and behavioral modules but also revealed opportunities to refine the CBT-H program.
CONCLUSIONS


These findings indicate that this new CBT-H program can potentially reduce depressive symptoms and improve self-efficacy in people with CDH. Furthermore, telehealth is a promising model for remote delivery and data collection to enhance participant accessibility and engagement.
CLINICAL TRIAL REGISTRATION


Registry: ClinicalTrials.gov; Name: Psychosocial Adjunctive Treatment for Hypersomnia (PATH); URL: https://clinicaltrials.gov/ct2/show/NCT03904238; Identifier: NCT03904238.",2020,"Qualitative data revealed enthusiasm for the accessibility of telehealth delivery and the usefulness of several cognitive and behavioral modules but also revealed opportunities to refine the CBT-H program.
","['35 adults with narcolepsy or idiopathic hypersomnia received a', 'people with central disorders of hypersomnolence (CDH) and co-occurring depressive symptoms', 'people with CDH']","['novel cognitive behavioral therapy for hypersomnia (CBT-H', '6-session CBT-H delivered individually or in small groups using videoconferencing', 'cognitive behavioral therapy']","['feasibility and acceptability', 'Patient Health Questionnaire (PHQ-8), Patient-Reported Outcomes Measurement Information System (PROMIS) measures, Epworth Sleepiness Scale (ESS', 'self-efficacy', 'depressive symptoms', 'Feasibility and acceptability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027404', 'cui_str': 'Narcolepsy'}, {'cui': 'C0033138', 'cui_str': 'Primary hypersomnia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0751229', 'cui_str': 'Hypersomnolence'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917799', 'cui_str': 'Hypersomnia'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0021428', 'cui_str': 'Information system'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",35.0,0.0492159,"Qualitative data revealed enthusiasm for the accessibility of telehealth delivery and the usefulness of several cognitive and behavioral modules but also revealed opportunities to refine the CBT-H program.
","[{'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Ong', 'Affiliation': 'Department of Neurology, Center for Circadian and Sleep Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Spencer C', 'Initials': 'SC', 'LastName': 'Dawson', 'Affiliation': 'Department of Neurology, Center for Circadian and Sleep Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Mundt', 'Affiliation': 'Department of Neurology, Center for Circadian and Sleep Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Moore', 'Affiliation': 'Department of Neurology, Center for Circadian and Sleep Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8750']
2095,32804087,Comparing the Keyto App and Device with Weight Watchers' WW App for Weight Loss: Protocol for a Randomized Trial.,"BACKGROUND


Obesity and being overweight are major contributing factors for many diseases. Calorie restricted diets often fail to result in sustained long-term weight loss. Very low-carbohydrate, high-fat ketogenic diets have been suggested to have superior metabolic and weight loss effects. Keyto is a low-cost, highly scalable mobile health (mHealth) app paired with a noninvasive biofeedback tool aimed at facilitating weight loss through a personalized healthy and predominantly plant- and fish-based ketogenic diet.
OBJECTIVE


This protocol describes a randomized trial comparing the efficacy of the Keyto mHealth app and device intervention to that of Weight Watchers' WW app in individuals who are overweight or obese. The primary outcome is weight loss after 12 weeks. Secondary and exploratory outcomes, including metabolic and cardiovascular risk factors, will be assessed at 12, 24, and 48 weeks.
METHODS


A total of 144 participants will be recruited and randomized to either the Keyto program or Weight Watchers program. Study participants will be guided through the study via video conference or phone calls and will undergo a fasting blood analysis performed by a third-party diagnostic lab at weeks 0 and 12 to assess metabolic and cardiovascular risk markers. All participants will be asked to weigh themselves daily on a study-provided Bluetooth-enabled scale. Participants randomized to the Keyto arm will also be asked to measure their breath acetone levels, a measure of ketosis, with the Keyto device 3 times per day.
RESULTS


Recruitment started in December 2019. Rolling recruitment is expected to be completed by July 2020. Data collection and analysis of the primary intervention phase is expected to be completed in October 2020. The 24- and 48-week follow-ups are expected to be completed in January 2021 and July 2021, respectively.
CONCLUSIONS


This trial will provide high-quality evidence regarding the efficacy of the Keyto weight loss program in individuals who are overweight and obese in a free-living condition. This study also fills a gap by examining the impact of a ketogenic diet emphasizing plant- and fish-based fats on blood lipid profile and cardiovascular disease risk.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04165707; https://clinicaltrials.gov/ct2/show/NCT04165707.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19053.",2020,"Secondary and exploratory outcomes, including metabolic and cardiovascular risk factors, will be assessed at 12, 24, and 48 weeks.
","['144 participants', 'individuals who are overweight or obese', 'individuals who are overweight and obese in a free-living condition']","['ketogenic diet emphasizing plant- and fish-based fats', 'Keyto weight loss program', 'Keyto program or Weight Watchers program', 'Keyto mHealth app and device intervention']","['weight loss', 'metabolic and cardiovascular risk factors']","[{'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",144.0,0.125617,"Secondary and exploratory outcomes, including metabolic and cardiovascular risk factors, will be assessed at 12, 24, and 48 weeks.
","[{'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Locke', 'Affiliation': 'University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Kaja', 'Initials': 'K', 'LastName': 'Falkenhain', 'Affiliation': 'University of British Columbia, Kelowna, BC, Canada.'}, {'ForeName': 'Dylan A', 'Initials': 'DA', 'LastName': 'Lowe', 'Affiliation': 'University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Ethan J', 'Initials': 'EJ', 'LastName': 'Weiss', 'Affiliation': 'University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Little', 'Affiliation': 'University of British Columbia, Kelowna, BC, Canada.'}]",JMIR research protocols,['10.2196/19053']
2096,32797232,A Randomized Comparative Trial of Targeted Steroid Injection via Epidural Catheter vs Standard Transforaminal Epidural Injection for the Treatment of Unilateral Cervical Radicular Pain: Six-Month Results.,"OBJECTIVES


Compare the effectiveness of catheter-directed cervical interlaminar epidural steroid injection (C-CIESI) with triamcinolone to cervical transforaminal steroid injection (CTFESI) with dexamethasone for the treatment of refractory unilateral radicular pain.
DESIGN


Prospective, randomized, comparative trial.
METHODS


Primary outcome: proportion of participants with ≥50% numeric rating scale pain score reduction from baseline ""dominant pain"" (the greater of arm vs neck) at one month postinjection. Secondary outcomes: ≥30% Neck Disability Index (NDI-5) reduction and Patient Global Impression of Change (PGIC) response indicating ""much improved"" or ""very much improved.""
RESULTS


One hundred twenty participants (55.6% females, 52.3 ± 12.5 years of age, BMI 28.2 ± 6.5 kg/m2), were enrolled. The proportions of participants who experienced ≥50% pain reduction at one, three, and six months were 68.5% (95% CI = 54.9-79.5%), 59.3% (95% CI = 45.7-71.6%), and 60.8% (95% CI = 46.7-73.2%), respectively, in the C-CIESI group compared with 49.1% (95% CI = 36.4-62.0%), 46.4% (95% CI = 33.8-59.6%), and 51.9% (95% CI = 38.4-65.2%), respectively, in the CTFESI group. The between-group difference at one month was significant (P = 0.038). The proportions of participants who experienced a ≥30% NDI-5 score improvement were 64.0% (95% CI = 49.8-76.1%) and 54.9% (95% CI = 41.1-68.0%) in the C-CIESI and CTFESI groups (P = 0.352). Participants reported similar PGIC improvement in both groups: At six months, 53.2% (95% CI 38.9-67.1%) and 54.5% (95% CI = 39.7-68.7%) of the C-CIESI and CTFESI groups reported being ""much improved"" or ""very much improved,"" respectively (P = 0.897).
CONCLUSIONS


Both C-CIESI with triamcinolone and CTFESI with dexamethasone are effective in reducing pain and disability associated with refractory unilateral cervical radiculopathy in a substantial proportion of participants for at least six months.",2020,"Participants reported similar PGIC improvement in both groups: At six months, 53.2% (95% CI 38.9-67.1%) and 54.5% (95% CI = 39.7-68.7%) of the C-CIESI and CTFESI groups reported being ""much improved"" or ""very much improved,"" respectively (P = 0.897).
","['One hundred twenty participants (55.6% females, 52.3\u2009±\u200912.5\u2009years of age, BMI 28.2\u2009±\u20096.5\u2009kg/m2), were enrolled', 'Unilateral Cervical Radicular Pain']","['triamcinolone', 'catheter-directed cervical interlaminar epidural steroid injection (C-CIESI', 'dexamethasone', 'triamcinolone and CTFESI with dexamethasone', 'Steroid Injection via Epidural Catheter vs Standard Transforaminal Epidural Injection']","['NDI-5 score improvement', 'pain reduction', 'pain and disability', 'PGIC improvement', 'Neck Disability Index (NDI-5) reduction and Patient Global Impression of Change (PGIC) response indicating ""much improved"" or ""very much improved', 'proportion of participants with ≥50% numeric rating scale pain score reduction from baseline ""dominant pain']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C4552559', 'cui_str': 'Cervical radicular pain'}]","[{'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1261311', 'cui_str': 'Injection of steroid'}, {'cui': 'C0179751', 'cui_str': 'Epidural catheter'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021486', 'cui_str': 'Injections, Peridural'}]","[{'cui': 'C1563705', 'cui_str': 'Diabetes Insipidus, Nephrogenic, Type I'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0442824', 'cui_str': 'Very'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",120.0,0.176804,"Participants reported similar PGIC improvement in both groups: At six months, 53.2% (95% CI 38.9-67.1%) and 54.5% (95% CI = 39.7-68.7%) of the C-CIESI and CTFESI groups reported being ""much improved"" or ""very much improved,"" respectively (P = 0.897).
","[{'ForeName': 'Zachary L', 'Initials': 'ZL', 'LastName': 'McCormick', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Conger', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Beau P', 'Initials': 'BP', 'LastName': 'Sperry', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Teramoto', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Petersen', 'Affiliation': 'Alabama College of Osteopathic Medicine, Dothan, Alabama.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Salazar', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Shellie', 'Initials': 'S', 'LastName': 'Cunningham', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Michael Henrie', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Bisson', 'Affiliation': 'Department of Neurosurgery, University of Utah School of Medicine, Salt Lake City, Utah, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kendall', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, Utah.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa242']
2097,32797236,Intravenous Paracetamol vs Intranasal Desmopressin for Renal Colic in the Emergency Department: A Randomized Clinical Trial.,"OBJECTIVE


To evaluate the analgesic efficacy of intranasal desmopressin alone vs intravenous paracetamol in patients referred to the emergency department with renal colic.
DESIGN


Randomized clinical trial.
SETTING


This study was conducted in the emergency unit of a university hospital.
SUBJECTS


Patients referred to the emergency room with renal colic.
PRIMARY OUTCOME


Effect of intranasal desmopressin in pain relief in comparison with intravenous paracetamol.
METHODS


In this trial, 240 patients diagnosed with renal colic were randomly divided into two groups to compare the analgesic effect of intravenous paracetamol (15 mg/kg) and intranasal desmopressin spray (40 μg). Pain scores were measured by a numeric rating scale at baseline and after 15, 30, and 60 minutes. Adverse effects and need for rescue analgesic (0.05 mg/kg max 3 mg morphine sulphate) were also recorded at the end of the study.
RESULTS


Three hundred patients were eligible for the study; however, 240 were included in the final analysis. The patients in the two groups were similar in their baseline characteristics and baseline pain scores. The mean pain score after 15 minutes was more reduced and was clinically significant (>3) in the desmopressin group (P < 0.0001). There was no significant difference between mean pain scores in the two groups after 30 minutes (P = 0.350) or 60 minutes (P = 0.269), but the efficacy of the two drugs was significant in terms of pain reduction (>6).
CONCLUSIONS


Our study showed that intranasal desmopressin is as effective as intravenous paracetamol for renal colic pain management; however, significant clinical reduction in pain score occurred faster with intranasal desmopressin.",2020,"There was no significant difference between mean pain scores in the two groups after 30 minutes (P = 0.350) or 60 minutes (P = 0.269), but the efficacy of the two drugs was significant in terms of pain reduction (>6).
","['patients referred to the emergency department with renal colic', 'Patients referred to the emergency room with renal colic', '240 patients diagnosed with renal colic', 'Renal Colic in the Emergency Department', 'emergency unit of a university hospital', 'Three hundred patients were eligible for the study; however, 240 were included in the final analysis']","['intravenous paracetamol', 'Intravenous Paracetamol', 'morphine sulphate', 'intranasal desmopressin', 'intranasal desmopressin alone vs intravenous paracetamol', 'intranasal desmopressin spray', 'Intranasal Desmopressin', 'paracetamol', 'desmopressin']","['baseline pain scores', 'pain relief', 'pain reduction', 'analgesic efficacy', 'numeric rating scale', 'mean pain scores', 'mean pain score', 'pain score', 'Pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0066814', 'cui_str': 'Morphine sulfate'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",240.0,0.179194,"There was no significant difference between mean pain scores in the two groups after 30 minutes (P = 0.350) or 60 minutes (P = 0.269), but the efficacy of the two drugs was significant in terms of pain reduction (>6).
","[{'ForeName': 'Hamed Basir', 'Initials': 'HB', 'LastName': 'Ghafouri', 'Affiliation': 'Emergency Medicine, Trauma and Injury Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Abazarian', 'Affiliation': 'Emergency Medicine, Alborz University of Medical Sciences, Karaj, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Yasinzadeh', 'Affiliation': 'Emergency Medicine, Trauma and Injury Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Modirian', 'Affiliation': 'Emergency Medicine, Qazvin University of Medical Sciences, Qazvin, Iran.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa240']
2098,32797292,"A study protocol for a randomized controlled trial of a cross-systems service delivery model to improve identification and care for HIV, STIs and substance use among justice-involved young adults.","BACKGROUND


Justice-involved young adults (JIYA) aged 18-24 are at significant risk for HIV and problematic substance use (SU) but are unlikely to know their HIV status or be linked to HIV or SU treatment and care. Intensive efforts to increase screening and improve linkage to HIV and SU services for JIYA are needed that address youth as well as justice and health/behavioral health system-level barriers.
METHODS


MoveUp is a four-session intervention that integrates evidence-based protocols to promote HIV and STI testing, HIV and SU behavioral risk reduction and engagement in treatment for JIYA. MoveUp is delivered onsite at an alternative sentencing program (ASP) by HIV testing outreach workers from a youth-focused medical and HIV treatment program. N = 450 youth are randomized following baseline assessment into two groups: MoveUp or standard of care. Youth are followed for 12 months following the intervention; unprotected sexual behavior, substance use, HIV and STI testing as well as treatment linkage will be assessed at 3, 6, 9 and 12-months.
DISCUSSION


This study is one of the first to systematically test an integrated screen/testing, prevention intervention and linkage-to-care services program (MoveUp), using evidence-based approaches to address the overlapping HIV/STI and substance use epidemics in JIYA by providing on-site services to identify HIV/STI and SU risk and treatment need within justice-settings as well as linkage to services in the community. This approach, capitalizing on health and justice partnerships, represents an innovation that can capitalize on missed opportunities for engaging JIYA in health care.",2020,"Youth are followed for 12 months following the intervention; unprotected sexual behavior, substance use, HIV and STI testing as well as treatment linkage will be assessed at 3, 6, 9 and","['Justice-involved young adults (JIYA) aged 18-24 are at significant risk for HIV and problematic substance use (SU', 'N\u2009=\u2009450 youth', 'justice-involved young adults']","['MoveUp or standard of care', 'integrated screen/testing, prevention intervention and linkage-to-care services program (MoveUp']",[],"[{'cui': 'C0022437', 'cui_str': 'Justice'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0366743,"Youth are followed for 12 months following the intervention; unprotected sexual behavior, substance use, HIV and STI testing as well as treatment linkage will be assessed at 3, 6, 9 and","[{'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'Elkington', 'Affiliation': 'Department of Psychiatry, Columbia University and the New York State Psychiatric Institute, New York, NY, USA. ke2143@cumc.columbia.edu.'}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': ""O'Grady"", 'Affiliation': 'University of Connecticut, School of Medicine Department of Public Health Sciences, 263 Farmington Avenue, Farmington, CT, 06030-6325, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Tross', 'Affiliation': 'Department of Psychiatry, Columbia University and the New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Wilson', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Watkins', 'Affiliation': 'Department of Psychiatry, Columbia University and the New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Lenore', 'Initials': 'L', 'LastName': 'Lebron', 'Affiliation': 'Center for Court Innovation, New York, NY, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Cohall', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Alwyn', 'Initials': 'A', 'LastName': 'Cohall', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, NY, USA.'}]",Health & justice,['10.1186/s40352-020-00121-7']
2099,32797324,Influence of postoperative complications on long-term outcome after oncologic lung resection surgery. Substudy of a randomized control trial.,"Lung resection surgery (LRS) causes an intense local and systemic inflammatory response. There is a relationship between inflammation and postoperative complications (POCs). Also, it has been proposed that the inflammation and complications related with the surgery may promote the recurrence of cancer and therefore deterioration of survival. We investigated the association between inflammatory biomarkers, severity of POCs and long-term outcome in patients who were discharged after LRS. This is a prospective substudy of a randomized control trial. We established three groups based in the presence of POCs evaluated by Clavien-Dindo (C-D) classification: Patients with no postoperative complications (No-POCs group) (C-D = 0), patients who developed light POCs (L-POCs group) (C-D = I-II), and major POCs (M-POCs group) (C-D = III, IV, or V). Kaplan-Meier curves and Cox regression model were created to compare survival and oncologic recurrence in those groups. Patients who developed POCs (light or major) had an increase in some inflammatory biomarkers (TNF-α, IL-6, IL-7, IL-8) compared with No-POCs group. This pro-inflammatory status plays a fundamental role in the appearance of POCs and therefore in a shorter life expectancy. Individuals in the M-POCs group had a higher risk of death (HR = 3.59, 95% CI 1.69 to 7.63) compared to individuals in the No-POCs group (p = 0.001). Patients of L-POCs group showed better survival than M-POCs group (HR = 2.16, 95% CI 1.00 to 4.65, p = 0.049). Besides, M-POCs patients had higher risk of recurrence in the first 2 years, when compared with L-POCs (p = 0,008) or with No-POCs (p = 0.002). In patients who are discharged after undergoing oncologic LRS, there is an association between POCs occurrence and long term outcome. Oncologist should pay special attention in patients who develop POCs after LRS.",2020,"Patients who developed POCs (light or major) had an increase in some inflammatory biomarkers (TNF-α, IL-6, IL-7, IL-8) compared with No-POCs group.","['patients who develop POCs after LRS', 'patients who were discharged after LRS', ' Patients with no postoperative complications (No-POCs group) (C-D\u2009=\u20090), patients who developed light POCs (L-POCs group) (C-D\u2009=\u2009I-II), and major POCs (M-POCs group']","['Lung resection surgery (LRS', 'oncologic lung resection surgery']","['risk of death', 'inflammation and postoperative complications (POCs', 'survival and oncologic recurrence', 'survival', 'risk of recurrence', 'inflammatory biomarkers (TNF-α, IL-6, IL-7, IL-8']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021761', 'cui_str': 'Interleukin-7'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}]",,0.0669892,"Patients who developed POCs (light or major) had an increase in some inflammatory biomarkers (TNF-α, IL-6, IL-7, IL-8) compared with No-POCs group.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Casanova Barea', 'Affiliation': 'Gregorio Maranon Hospital, Madrid, Spain. javiercasanovabarea@yaho.es.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'De la Gala', 'Affiliation': 'Gregorio Maranon Hospital, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Piñeiro', 'Affiliation': 'Gregorio Maranon Hospital, Madrid, Spain.'}, {'ForeName': 'Almudena', 'Initials': 'A', 'LastName': 'Reyes', 'Affiliation': 'Gregorio Maranon Hospital, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Simón', 'Affiliation': 'Gregorio Maranon Hospital, Madrid, Spain.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Rancan', 'Affiliation': 'Medicine Faculty in Complutense University, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Vara', 'Affiliation': 'Medicine Faculty in Complutense University, Madrid, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Paredes', 'Affiliation': 'Medicine Faculty in Complutense University, Madrid, Spain.'}, {'ForeName': 'Jose María', 'Initials': 'JM', 'LastName': 'Bellón', 'Affiliation': 'Gregorio Maranon Hospital, Madrid, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Garutti Martinez', 'Affiliation': 'Gregorio Maranon Hospital, Madrid, Spain.'}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00580-1']
2100,32797375,"Does probiotic supplementation aid weight loss? A randomized, single-blind, placebo-controlled study with Bifidobacterium lactis BS01 and Lactobacillus acidophilus LA02 supplementation.","PURPOSE


Probiotic supplements are gaining popularity worldwide. This trend is especially present in females, and a common motivation for consumption is weight loss, no matter the BMI. The aim of this study was to investigate the effects of probiotic supplementation on weight loss in healthy, young adult females and to put claims made by manufacturers of such products to the test.
METHODS


The study utilizes a randomized, single-blind, placebo-control design. 53 females aged 19-33 were enrolled, and 38 completed the trial. A 6 week supplementation with Bifidobacterium lactis BS01 and Lactobacillus acidophilus LA02 or placebo was conducted. Anthropometric measures (body mass, BMI, body fat percentage, arm skinfold fat, waist circumference, and WHR) were applied pre and post-treatment.
RESULTS


No significant changes in anthropometric measures were observed in both supplementation and placebo groups.
CONCLUSION


The results of this investigation do not support claims made by probiotic products manufacturers, that they aid weight loss. Our results seem to support an argument that weight loss is mostly associated with food habits and dietary behaviors, not probiotic intake. It is possible that probiotic supplementation may play a facilitating weight loss but has no effect without dietary intervention. Another possible explanation is that due to strain specificity-bacteria strains used in this study are not effective for weight loss.
LEVEL OF EVIDENCE


I: randomized controlled trial.",2020,"No significant changes in anthropometric measures were observed in both supplementation and placebo groups.
","['healthy, young adult females', '53 females aged 19-33 were enrolled, and 38 completed the trial']","['probiotic supplementation', 'Bifidobacterium lactis BS01 and Lactobacillus acidophilus LA02 supplementation', 'Bifidobacterium lactis BS01 and Lactobacillus acidophilus LA02 or placebo', 'placebo']","['weight loss', 'anthropometric measures', 'Anthropometric measures (body mass, BMI, body fat percentage, arm skinfold fat, waist circumference, and WHR']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}]",53.0,0.108238,"No significant changes in anthropometric measures were observed in both supplementation and placebo groups.
","[{'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Czajeczny', 'Affiliation': 'Chair and Department of Clinical Psychology, Poznan University of Medical Sciences, Poznan, Poland. d.czajeczny@gmail.com.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Kabzińska', 'Affiliation': 'Chair and Department of Clinical Psychology, Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Rafał Wojciech', 'Initials': 'RW', 'LastName': 'Wójciak', 'Affiliation': 'Chair and Department of Clinical Psychology, Poznan University of Medical Sciences, Poznan, Poland.'}]",Eating and weight disorders : EWD,['10.1007/s40519-020-00983-8']
2101,32797376,Long-term outcomes of induction chemotherapy followed by chemoradiotherapy vs chemoradiotherapy alone as treatment of unresectable head and neck cancer: follow-up of the Spanish Head and Neck Cancer Group (TTCC) 2503 Trial.,"BACKGROUND


Our previous phase-3 study (TTCC 2503) failed to show overall survival advantage of 2 induction chemotherapy (IC) regimens followed by standard concurrent chemoradiotherapy (CRT) over CRT alone in patients with unresectable locally advanced head and neck squamous-cell carcinoma (LAHNSCC). This study described the long-term survival of those patients.
MATERIALS AND METHODS


Long-term follow-up study of patients with untreated LAHNSCC assigned to IC (three cycles), with either docetaxel, cisplatin and 5-fluorouracil (TPF arm) or cisplatin and 5-fluorouracil (PF arm), followed by CRT, or CRT alone, included in the previous TTCC 2503 trial.
RESULTS


In the intention-to-treat population (n = 439), the median OS times were 25.4 (95% CI, 16.8-34.4), 26.2 (95% CI, 18.2-36.6) and 25.4 months (95% CI, 17.4-36.0) in the TPF-CRT, PF-CRT and CRT arms, respectively (log-rank p = 0.51). In the per-protocol population (n = 355), patients with larynx-hypopharynx primary tumors treated with IC (TPF or PF) followed by CRT had a longer median PFS than those who received CRT alone. Moreover, patients with ECOG 0 treated with IC (TPF or PF) followed by CRT had a better TTF than those with CRT alone. There were no statistically significant differences in terms of OS, PFS or TTF, according to the tumor load or affected nodes.
CONCLUSION


After a long follow-up, the TTCC 2503 trial failed to show the benefit of IC-CRT in unresectable LAHNSCC regarding the primary end point. However, fit patients with ECOG 0 and primary larynx-hypopharyngeal tumors may benefit from the use of IC if administered by an experienced team. ClinicalTrials.gov identifier NCT00261703.",2020,"There were no statistically significant differences in terms of OS, PFS or TTF, according to the tumor load or affected nodes.
","['Long-term follow-up study of patients with untreated LAHNSCC assigned to IC (three cycles), with either', 'patients with unresectable locally advanced head and neck squamous-cell carcinoma (LAHNSCC', 'unresectable head and neck cancer', 'patients with larynx-hypopharynx primary tumors treated with']","['CRT', 'IC (TPF or PF', 'induction chemotherapy', 'Neck Cancer Group (TTCC', 'docetaxel, cisplatin and 5-fluorouracil (TPF arm) or cisplatin and 5-fluorouracil (PF arm), followed by CRT, or CRT alone', 'chemoradiotherapy vs chemoradiotherapy alone', 'induction chemotherapy (IC) regimens followed by standard concurrent chemoradiotherapy (CRT) over CRT alone']","['median OS times', 'overall survival advantage', 'OS, PFS or TTF, according to the tumor load or affected nodes', 'median PFS']","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0023051', 'cui_str': 'Disorder of the larynx'}, {'cui': 'C0020629', 'cui_str': 'Hypopharyngeal structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0746787', 'cui_str': 'Malignant tumor of neck'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C4087167', 'cui_str': 'Tumour treating fields therapy'}, {'cui': 'C1449699', 'cui_str': 'Tumor Load'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",,0.198812,"There were no statistically significant differences in terms of OS, PFS or TTF, according to the tumor load or affected nodes.
","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hitt', 'Affiliation': 'Medical Oncology Department, Hospital Universitario Severo Ochoa, Avda. de Orellana, s/n, 28911, Leganés (Madrid), Spain. rhitt@telefonica.net.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Iglesias', 'Affiliation': 'Medical Oncology Department, Hospital Universitario, 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'López-Pousa', 'Affiliation': 'Medical Oncology Department, Hospital de la Santa Creu i Sant Pau, Calalunya, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Berrocal-Jaime', 'Affiliation': 'Medical Oncology Department, Consorci Hospital General Universitari de Valencia, Valencia, Spain.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Grau', 'Affiliation': 'Medical Oncology Department, Hospital Clinic de Barcelona, Catalunya, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'García-Girón', 'Affiliation': 'Medical Oncology Department, Hospital Universitario de Burgos, Castilla y León, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Martínez-Trufero', 'Affiliation': 'Medical Oncology Department, Hospital Universitario Miguel Servet, Aragón, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Guix', 'Affiliation': 'Medical Oncology Department, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lambea-Sorrosal', 'Affiliation': 'Medical Oncology Department, Hospital Clínico Lozano Blesa, Zaragoza, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Del Barco-Morillo', 'Affiliation': 'Medical Oncology Department, Hospital Universitario de Salamanca, Castilla y León, Spain.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'León-Vintró', 'Affiliation': 'ENT Department, Hospital de la Santa Creu i Sant Pau, Catalunya, Spain.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Cunquero-Tomas', 'Affiliation': 'Medical Oncology Department, Consorci Hospital General Universitari de Valencia, Valencia, Spain.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Baste', 'Affiliation': 'Medical Oncology Department, Hospital Clinic de Barcelona, Catalunya, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ocaña', 'Affiliation': 'Medical Oncology Department, Hospital Universitario de Salamanca, Castilla y León, Spain.'}, {'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Cruz-Hernández', 'Affiliation': 'Medical Oncology Department, Hospital Universitario de Salamanca, Castilla y León, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico,['10.1007/s12094-020-02467-8']
2102,32797585,Balancing Work and Family: A Controlled Evaluation of the Triple P- Positive Parenting Program as a Work-Site Intervention.,"BACKGROUND


Despite a wealth of evidence showing that behavioural family intervention is an effective intervention for parents of children with behavioural and emotional problems, little attention has been given to the relationship between parents functioning at work and their capacity to manage parenting and other home responsibilities. This study evaluated the effects of a group version of the Triple-P Positive Parenting Program (WPTP) designed specifically for delivery in the workplace.
METHOD


Participants were 42 general and academic staff from a major metropolitan university who were reporting difficulties managing home and work responsibilities and behavioural difficulties with their children. Participants were randomly assigned to WPTP, or to a waitlist control (WL) condition.
RESULTS


Following intervention, parents in WPTP reported significantly lower levels of disruptive child behaviour, dysfunctional parenting practices, and higher levels of parental self-efficacy in managing both home and work responsibilities, than parents in the WL condition. These short-term improvements were maintained at 4-months follow-up. There were also additional improvements in reported levels of work stress and parental distress at follow-up in the WPTP group compared to post-intervention.
CONCLUSIONS


Implications for the development of 'family-friendly' work environments and the prevention of child behaviour problems are discussed.",2003,"There were also additional improvements in reported levels of work stress and parental distress at follow-up in the WPTP group compared to post-intervention.
","['parents of children with behavioural and emotional problems', 'Balancing Work and Family', 'Participants were 42 general and academic staff from a major metropolitan university who were reporting difficulties managing home and work responsibilities and behavioural difficulties with their children']","['WPTP', 'Triple P', 'Triple-P Positive Parenting Program (WPTP', 'WPTP, or to a waitlist control (WL) condition']","['disruptive child behaviour, dysfunctional parenting practices, and higher levels of parental self-efficacy', 'levels of work stress and parental distress']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C4040683', 'cui_str': 'Triple P - Positive Parenting Program'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",42.0,0.037755,"There were also additional improvements in reported levels of work stress and parental distress at follow-up in the WPTP group compared to post-intervention.
","[{'ForeName': 'Alicia J', 'Initials': 'AJ', 'LastName': 'Martin', 'Affiliation': 'Parenting and Family Support Centre, The University of Queensland, Brisbane 4072, Australia. E-mail: m.sanders@psy.uq.edu.au.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sanders', 'Affiliation': 'Parenting and Family Support Centre, The University of Queensland, Brisbane 4072, Australia. E-mail: m.sanders@psy.uq.edu.au.'}]",Child and adolescent mental health,['10.1111/1475-3588.00066']
2103,32797700,The effect of an ultrasound-activated needle tip tracker needle on the performance of sciatic nerve block on a soft embalmed Thiel cadaver.,"In this study, we measured the performance of medical students and anaesthetists using a new tracker needle during simulated sciatic nerve block on soft embalmed cadavers. The tracker needle incorporates a piezo element near its tip that generates an electrical signal in response to insonation. A circle, superimposed on the ultrasound image surrounding the needle tip, changes size and colour according to the position of the piezo element within the ultrasound beam. Our primary objective was to compare sciatic block performance with the tracker switched on and off. Our secondary objectives were to record psychometrics, procedure efficiency, participant self-regulation and focused attention using eye-tracking technology. Our primary outcome measures were the number of steps successfully performed and the number of errors committed during each block. Videos were scored by trained experts using validated checklists. Sequential tracker activation and deactivation was randomised equally within subjects. With needle activation, steps improved in 10 (25%) subjects and errors reduced in six (15%) subjects. The most important steps were: needle tip identification before injection, OR (95%CI) 2.12 (1.61-2.80; p < 0.001); and needle tip identification before advance of the needle, 1.80 (1.36-2.39; p < 0.001). The most important errors were: failure to identify the needle tip before injection, 2.40 (1.78-3.24; p < 0.001); and failure to quickly regain needle tip position when tip visibility was lost, 2.03 (1.5-2.75; p < 0.001). In conclusion, needle-tracking technology improved performance in a quarter of subjects.",2020,"With needle activation, steps improved in 10 (25%) subjects and errors reduced in six (15%) subjects.",['medical students and anaesthetists using a new tracker needle during simulated sciatic nerve block on soft embalmed cadavers'],['ultrasound-activated needle tip tracker needle'],"['record psychometrics, procedure efficiency, participant self-regulation and focused attention using eye-tracking technology', 'number of steps successfully performed and the number of errors committed during each block', 'sciatic block performance']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0394735', 'cui_str': 'Injection of anesthetic agent into sciatic nerve'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0006629', 'cui_str': 'Cadaver'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0339897', 'cui_str': 'Transjugular intrahepatic portosystemic shunt'}]","[{'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0589098', 'cui_str': 'Focused attention'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",,0.0268927,"With needle activation, steps improved in 10 (25%) subjects and errors reduced in six (15%) subjects.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'McKendrick', 'Affiliation': 'Department of Psychology, Heriot-Watt University, Edinburgh, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sadler', 'Affiliation': 'Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': 'Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Seeley', 'Affiliation': 'Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Filipescu', 'Affiliation': 'Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mustafa', 'Affiliation': 'Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'McKendrick', 'Affiliation': 'Optomize Ltd, Glasgow, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Halcrow', 'Affiliation': 'Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Raju', 'Affiliation': 'Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'McLeod', 'Affiliation': 'Ninewells Hospital, Dundee, UK.'}]",Anaesthesia,['10.1111/anae.15211']
2104,32796392,Adjunctive Raloxifene and Isradipine Improve Cognitive Functioning in Patients With Schizophrenia: A Pilot Study.,"BACKGROUND


Cognitive impairment is the most important feature of schizophrenia leading to severe functional disability. To identify pathways that improve pathophysiological neurocognition in schizophrenia is a current challenge for the development of goal-directed clinical interventions. In the present study, we investigated the effects of raloxifene (a selective estrogen modulator) and isradipine (a voltage-gated L-type calcium channel blocker) on cognitive deficits in patients with schizophrenia.
METHOD


We designed a double-blind, randomized, parallel, placebo-controlled trial. We randomized 60 patients with schizophrenia into 3 groups including isradipine 5 mg, raloxifine 60 mg, and placebo for 6 consequent weeks, all in the same shape capsules, 2 times a day, along with treatment as usual. The initial and final results of blood tests, electrocardiograms, and cognitive tests in specific domains, such as attention, processing speed, executive function, and verbal memory were evaluated.
RESULTS


Our findings revealed a remarkable association between adjunctive raloxifene treatment and the alleviation of verbal memory deficits. Isradipine treatment significantly improved the verbal memory and attention dysfunction in some variables of the Stroop test, compared with the placebo. However, no effect was observed in processing speed and executive function deficits.
CONCLUSIONS


To the best of our knowledge, this study provides the first evidence that isradipine is a novel therapy option improving verbal memory and attention, both related to its activity in the hippocampus and the cerebellum. Further investigations are necessary to elucidate the mechanisms of action for both drugs in schizophrenia.",2020,"Isradipine treatment significantly improved the verbal memory and attention dysfunction in some variables of the Stroop test, compared with the placebo.","['Patients With Schizophrenia', '60 patients with schizophrenia into 3 groups including', 'patients with schizophrenia']","['Isradipine', 'Adjunctive Raloxifene and Isradipine', 'isradipine', 'isradipine (a voltage-gated L-type calcium channel blocker', 'isradipine 5 mg, raloxifine 60 mg, and placebo', 'raloxifene', 'placebo']","['blood tests, electrocardiograms, and cognitive tests in specific domains, such as attention, processing speed, executive function, and verbal memory', 'Cognitive Functioning', 'verbal memory and attention dysfunction', 'alleviation of verbal memory deficits', 'processing speed and executive function deficits', 'cognitive deficits']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0071304', 'cui_str': 'Isradipine'}, {'cui': 'C0244404', 'cui_str': 'Raloxifene'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0288263', 'cui_str': 'L-Type Calcium Channels'}, {'cui': 'C0987008', 'cui_str': 'Isradipine 5 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018941', 'cui_str': 'Blood test'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]",60.0,0.0752954,"Isradipine treatment significantly improved the verbal memory and attention dysfunction in some variables of the Stroop test, compared with the placebo.","[{'ForeName': 'Bita', 'Initials': 'B', 'LastName': 'Vahdani', 'Affiliation': 'From the Department of Psychiatry, Bahamn Hospital, Qazvin University of Medical Sciences, Qazvin.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Armani Kian', 'Affiliation': 'Department of Psychiatry, Beheshti Hospital.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Esmaeilzadeh', 'Affiliation': 'Department of Immunology.'}, {'ForeName': 'Saeedeh', 'Initials': 'S', 'LastName': 'Zenoozian', 'Affiliation': 'Department of Clinical Psychology, Beheshti Hospital.'}, {'ForeName': 'Vida', 'Initials': 'V', 'LastName': 'Yousefi', 'Affiliation': 'Department of Clinical Psychology, Beheshti Hospital.'}, {'ForeName': 'Saeideh', 'Initials': 'S', 'LastName': 'Mazloomzadeh', 'Affiliation': 'Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran.'}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001274']
2105,32796391,Anti-inflammatory Combination Therapy for the Treatment of Schizophrenia.,"BACKGROUND


Despite adequate antipsychotic treatment, most people with schizophrenia continue to exhibit persistent positive and negative symptoms and cognitive impairments. The current study was designed to examine the efficacy and safety of adjunctive anti-inflammatory combination therapy for these illness manifestations.
METHODS


Thirty-nine people with either Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, schizophrenia or schizoaffective disorder were entered into a 12-week double-blind, 2-arm, triple-dummy, placebo-controlled, randomized clinical trial: 19 were randomized to anti-inflammatory combination therapy and 20 were randomized to placebo. The Brief Psychiatric Rating Scale positive symptom item total score was used to assess positive symptom change, the Scale for the Assessment of Negative Symptoms total score was used to assess negative symptom change, the Calgary Depression Scale total score was used to assess depressive symptom change, and the MATRICS Consensus Cognitive Battery was used to assess neuropsychological test performance.
RESULTS


There was a significant time effect for Brief Psychiatric Rating Scale positive symptom item score (t226 = -2.66, P = 0.008), but the treatment (t54=1.52, P = 0.13) and treatment × time (t223 = 0.47, P = 0.64) effects were not significant. There were no significant time (t144 = 0.53, P = 0.72), treatment (t58=0.48, P = 0.63), or treatment × time (t143 = -0.20, P = 0.84) effects for the Scale for the Assessment of Negative Symptoms total score; or for any of the other symptom measures. There were no significant group differences in the change in the MATRICS Consensus Cognitive Battery composite score over the course of the study (F1,26=2.20, P = 0.15).
CONCLUSIONS


The study results suggest that there is no significant benefit of combined anti-inflammatory treatment for persistent positive symptoms or negative symptoms or cognitive impairments (clinicaltrials.gov trial number: NCT01514682).",2020,"There was a significant time effect for Brief Psychiatric Rating Scale positive symptom item score (t226 = -2.66, P = 0.008), but the treatment (t54=1.52, P = 0.13) and treatment × time (t223 = 0.47, P = 0.64) effects were not significant.","['Thirty-nine people with either Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, schizophrenia or schizoaffective disorder']","['adjunctive anti-inflammatory combination therapy', 'anti-inflammatory combination therapy', 'placebo']","['Brief Psychiatric Rating Scale positive symptom item score', 'Consensus Cognitive Battery composite score', 'negative symptom change, the Calgary Depression Scale total score', 'Brief Psychiatric Rating Scale positive symptom item total score', 'efficacy and safety', 'neuropsychological test performance']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}]","[{'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}]",19.0,0.122251,"There was a significant time effect for Brief Psychiatric Rating Scale positive symptom item score (t226 = -2.66, P = 0.008), but the treatment (t54=1.52, P = 0.13) and treatment × time (t223 = 0.47, P = 0.64) effects were not significant.","[{'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Buchanan', 'Affiliation': 'From the Maryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Weiner', 'Affiliation': ''}, {'ForeName': 'Deanna L', 'Initials': 'DL', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Gold', 'Affiliation': ''}, {'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Zaranski', 'Affiliation': ''}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Blatt', 'Affiliation': ''}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Wehring', 'Affiliation': ''}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Carpenter', 'Affiliation': ''}]",Journal of clinical psychopharmacology,['10.1097/JCP.0000000000001253']
2106,32796442,Microstructural Changes in Cystoid Macular Edema in Retinitis Pigmentosa after Intravitreal Dexamethasone Implant Injection.,"PURPOSE


To evaluate microstructural changes in cystoid macular edema (CME) in retinitis pigmentosa (RP) after intravitreal dexamethasone implant injection.
METHODS


In an extended cohort of a randomized trial of intravitreal dexamethasone implant for the management of RP-CME, microstructural changes during six months after treatment were evaluated using spectral domain optical coherence tomography.
RESULTS


Forty-two eyes were included, and all had cystoid space in the inner nuclear layer (INL) at baseline. No eyes showed subretinal fluid, and 28.6% showed hyperreflective foci. Among 38 eyes with cystoid space both in the INL and outer nuclear layer/Henle's layer (ONL/HL), 13 (34.2%) showed complete resolution and 12 (31.6%) showed cystoid space only in the INL at 2 months after injection, while others showed persistent cystoid space in both layers. After complete resolution, cystoid space recurrence was earlier in the INL than in the ONL/HL. Multivariable analysis showed that greater cystoid space area in the INL and ONL/HL, presence of macular leakage, and longer intact external limiting membrane at baseline were associated with greater cystoid space area decrease after treatment.
CONCLUSION


Resolution and recurrence pattern of RP-CME after dexamethasone treatment showed that the INL is the primary layer of cystic change, and this suggests its pathogenesis is most likely due to Müller cell dysfunction.",2020,"After complete resolution, cystoid space recurrence was earlier in the INL than in the ONL/HL.","['cystoid macular edema (CME) in retinitis pigmentosa (RP', 'Forty-two eyes were included, and all had cystoid space in the inner nuclear layer (INL) at baseline', 'Cystoid Macular Edema in Retinitis Pigmentosa after Intravitreal Dexamethasone Implant Injection']","['dexamethasone', 'intravitreal dexamethasone']","['hyperreflective foci', 'subretinal fluid', 'cystoid space recurrence', 'complete resolution', 'cystoid space']","[{'cui': 'C0024440', 'cui_str': 'Cystoid macular edema'}, {'cui': 'C0035334', 'cui_str': 'Retinitis pigmentosa'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C1720732', 'cui_str': 'Subretinal fluid'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",42.0,0.0344495,"After complete resolution, cystoid space recurrence was earlier in the INL than in the ONL/HL.","[{'ForeName': 'Un Chul', 'Initials': 'UC', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Jung Hyun', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Chang Ki', 'Initials': 'CK', 'LastName': 'Yoon', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Hyeong Gon', 'Initials': 'HG', 'LastName': 'Yu', 'Affiliation': 'Department of Ophthalmology, College of Medicine, Seoul National University, Seoul, Korea.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002944']
2107,32796456,INYBI: A New Tool for Self-Myofascial Release of the Suboccipital Muscles in Patients with Chronic Non-Specific Neck Pain: A Randomized Controlled Trial.,"STUDY DESIGN


A randomized, single-blinded (the outcome assessor was unaware of participants' allocation group) controlled clinical trial.
OBJECTIVE


To investigate the effects of myofascial release therapy (MRT) over the suboccipital muscles, compared with self-MRT using a novel device, the INYBI tool, on pain-related outcomes, active cervical mobility, and vertical mouth opening, in adults with chronic non-specific neck pain (NSNP).
SUMMARY OF BACKGROUND DATA


MRT is used to manage chronic musculoskeletal pain conditions, with purported positive effects. The efficacy of self-MRT, compared to MRT, has been scarcely evaluated.
METHODS


Fifty-eight participants (mean age of 34.6 ± 4.7 years; range 21-40 years; 77.6% females, 22.4% males) with persistent NSNP agreed to participate, and were equally distributed into an INYBI (n = 29) or a control group (n = 29). Both groups underwent a single 5-minutes intervention session. For participants in the control group, MRT of the suboccipital muscles was performed using the suboccipital muscle inhibition technique, while those in the INYBI group underwent a self-MRT intervention using the INYBI device. Primary measurements were taken of pain intensity (Visual Analogue Scale), local pressure pain sensitivity, as assessed with an algometer, and active cervical range-of-movement. Secondary outcomes included pain-free vertical mouth opening. Outcomes were collected at baseline, immediately after intervention and 45 minutes later.
RESULTS


The ANOVAs demonstrated no significant between-groups effect for any variable (all, p > 0.05). In the within-groups comparison, all participants significantly improved pain-related outcomes, and showed similar positive changes for mouth opening. Cervical range-of-movement- mainly increased after intervention for participants in the control group.
CONCLUSION


Both, MRT and self-MRT using the INYBI, are equally effective to enhance self-reported pain intensity, and local pressure pain sensitivity in chronic NSNP patients. For cervical mobility, MRT appears to be slighlty superior, compared to the INYBI, to achieve improvements in this population.
LEVEL OF EVIDENCE


2.",2020,"Cervical range-of-movement- mainly increased after intervention for participants in the control group.
","['adults with chronic non-specific neck pain (NSNP', 'Patients with Chronic Non-Specific Neck Pain', 'participants in the control group', 'chronic NSNP patients', 'Fifty-eight participants (mean age of 34.6\u200a±\u200a4.7 years; range 21-40 years; 77.6% females, 22.4% males) with persistent NSNP agreed to participate, and were equally distributed into an INYBI (n\u200a=\u200a29) or a control group (n\u200a=\u200a29']","['INYBI', 'self-MRT', 'myofascial release therapy (MRT', 'self-MRT intervention']","['Cervical range-of-movement- mainly', 'pain-free vertical mouth opening', 'pain-related outcomes', 'pain intensity, and local pressure pain sensitivity', 'pain intensity (Visual Analogue Scale), local pressure pain sensitivity, as assessed with an algometer, and active cervical range-of-movement', 'positive changes for mouth opening']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",58.0,0.086756,"Cervical range-of-movement- mainly increased after intervention for participants in the control group.
","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Pérez-Martínez-Casero', 'Affiliation': 'Escuela de Osteopatía de Madrid, Madrid, Spain.'}, {'ForeName': 'Kristobal', 'Initials': 'K', 'LastName': 'Gogorza-Arroitaonandia', 'Affiliation': 'Escuela de Osteopatía de Madrid, Madrid, Spain.'}, {'ForeName': 'Alberto Marcos', 'Initials': 'AM', 'LastName': 'Heredia-Rizo', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Sevilla, Sevilla, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Salas-González', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Sevilla, Sevilla, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Oliva-Pascual-Vaca', 'Affiliation': 'Department of Physiotherapy, Faculty of Nursing, Physiotherapy and Podiatry, University of Sevilla, Sevilla, Spain.'}]",Spine,['10.1097/BRS.0000000000003605']
2108,32796502,Effects of a Physical Activity Program Potentiated with ICTs on the Formation and Dissolution of Friendship Networks of Children in a Middle-Income Country.,"This paper assesses the potential cohesion effect of a physical activity (PA) school-based intervention potentiated using text messages (SMS) through analyzing longitudinally the friendship network structure and the mechanisms of the formation and dissolution of friendships. Three schools ( n  = 125 participants) in Bogotá, Colombia, were randomly assigned into three groups: Modulo Activo Recreo Activo (MARA) + SMS (networks 1 and 2), MARA (networks 3 and 4), and control (no intervention: networks 5-7). We collected socio-economic, health-related, network structure, and intervention satisfaction variables in the baseline and after 10 weeks on July-November 2013. For each classroom network, we conducted four models using a temporal and static network approach to assess (1) temporal social network changes, (2) friendship homophily, (3) friendship formation and dissolution mechanisms, and (4) effect of SMS on the networks' cohesion. We found that (1) social cohesion emerged in the four intervened networks that were measured over time with transitivity and homophily driven by clustering, (2) the intervention affected the mechanisms of friendship formation and dissolution, and (3) MARA + SMS on average created more social cohesion and 3.8 more friendships than the program alone. Potentially, school-based interventions with information and communication technologies (ICT) such as MARA + SMS could encourage social cohesion among children. The particular characteristics of each school network need to be considered when developing school-based interventions.",2020,"We found that (1) social cohesion emerged in the four intervened networks that were measured over time with transitivity and homophily driven by clustering, (2) the intervention affected the mechanisms of friendship formation and dissolution, and (3) MARA + SMS on average created more social cohesion and 3.8 more friendships than the program alone.","['Children in a Middle-Income Country', 'Three schools ( n  = 125 participants) in Bogotá, Colombia', 'children']","['Modulo Activo Recreo Activo (MARA) + SMS (networks 1 and 2), MARA (networks 3 and 4), and control (no intervention: networks 5-7', 'physical activity (PA) school-based intervention potentiated using text messages (SMS', 'information and communication technologies (ICT) such as MARA + SMS', 'Physical Activity Program Potentiated with ICTs']",['Formation and Dissolution of Friendship Networks'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}]","[{'cui': 'C0445579', 'cui_str': 'Recreo'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0324975', 'cui_str': 'Dolichotis patagonum'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0683867', 'cui_str': 'Information Technology'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]",,0.0241644,"We found that (1) social cohesion emerged in the four intervened networks that were measured over time with transitivity and homophily driven by clustering, (2) the intervention affected the mechanisms of friendship formation and dissolution, and (3) MARA + SMS on average created more social cohesion and 3.8 more friendships than the program alone.","[{'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Guerra', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Montes', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Andrés F', 'Initials': 'AF', 'LastName': 'Useche', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Ana María', 'Initials': 'AM', 'LastName': 'Jaramillo', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Silvia A', 'Initials': 'SA', 'LastName': 'González', 'Affiliation': ""Healthy Active Living and Obesity Research Group, Children's Hospital of Eastern Ontario Research Institute, Ottawa, ON K1H 8L1, Canada.""}, {'ForeName': 'Jose D', 'Initials': 'JD', 'LastName': 'Meisel', 'Affiliation': 'Social and Health Complexity Center, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Obando', 'Affiliation': 'INRIA, Institut du Cerveau et de la Moelle épinière, ICM, Inserm U 1127, CNRS UMR 7225, Sorbonne Université, 75013 Paris, France.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Cardozo', 'Affiliation': 'Department of Industrial Engineering, Universidad de Los Andes, Bogotá 111711, Colombia.'}, {'ForeName': 'Ruth F', 'Initials': 'RF', 'LastName': 'Hunter', 'Affiliation': ""Centre for Public Health, School of Medicine, Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast BT7 1NN, UK.""}, {'ForeName': 'Olga L', 'Initials': 'OL', 'LastName': 'Sarmiento', 'Affiliation': 'School of Medicine, Universidad de los Andes, Bogotá 111711, Colombia.'}]",International journal of environmental research and public health,['10.3390/ijerph17165796']
2109,32796597,High Throughput Molecular Characterization of Normal Karyotype Acute Myeloid Leukemia in the Context of the Prospective Trial 02/06 of the Northern Italy Leukemia Group (NILG).,"By way of a Next-Generation Sequencing NGS high throughput approach, we defined the mutational profile in a cohort of 221 normal karyotype acute myeloid leukemia (NK-AML) enrolled into a prospective randomized clinical trial, designed to evaluate an intensified chemotherapy program for remission induction.  NPM1 ,  DNMT3A,  and  FLT3 -ITD were the most frequently mutated genes while  DNMT3A ,  FLT3 ,  IDH1 ,  PTPN11 , and  RAD21  mutations were more common in the  NPM1  mutated patients ( p  < 0.05).  IDH1  R132H mutation was strictly associated with  NPM1  mutation and mutually exclusive with  RUNX1  and  ASXL1 . In the whole cohort of NK-AML, no matter the induction chemotherapy used, by multivariate analysis, the achievement of complete remission was negatively affected by the  SRSF2  mutation. Alterations of  FLT3  ( FLT3- ITD) and  U2AF1  were associated with a worse overall and disease-free survival ( p  < 0.05).  FLT3- ITD positive patients who proceeded to alloHSCT had a survival probability similar to  FLT3- ITD negative patients and the transplant outcome was no different when comparing high and low-AR- FLT3 -ITD subgroups in terms of both OS and DFS. In conclusion, a comprehensive molecular profile for NK-AML allows for the identification of genetic lesions associated to different clinical outcomes and the selection of the most appropriate and effective treatment strategies, including stem cell transplantation and targeted therapies.",2020,Alterations of  FLT3  ( FLT3- ITD) and  U2AF1  were associated with a worse overall and disease-free survival ( p  < 0.05).  ,"['221 normal karyotype acute myeloid leukemia (NK-AML', 'Northern Italy Leukemia Group (NILG']",['FLT3'],"['complete remission', 'NPM1 ,  DNMT3A,  and  FLT3 -ITD', 'IDH1', 'Alterations of  FLT3  ( FLT3- ITD', 'survival probability', 'overall and disease-free survival']","[{'cui': 'C3839868', 'cui_str': 'Cytogenetically normal acute myeloid leukemia'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0023418', 'cui_str': 'Leukemia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0251006', 'cui_str': 'FLT3 protein, human'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0069141', 'cui_str': 'nucleophosmin'}, {'cui': 'C0251006', 'cui_str': 'FLT3 protein, human'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}]",221.0,0.0620904,Alterations of  FLT3  ( FLT3- ITD) and  U2AF1  were associated with a worse overall and disease-free survival ( p  < 0.05).  ,"[{'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Salmoiraghi', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Cavagna', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Zanghì', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Pavoni', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Michelato', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Ksenija', 'Initials': 'K', 'LastName': 'Buklijas', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Elidi', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Intermesoli', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Lussana', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Oldani', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Caprioli', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Stefanoni', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Gianfaldoni', 'Affiliation': 'Hematology Unit, Azienda Ospedaliera Universitaria Careggi, 50134 Firenze, Italy.'}, {'ForeName': 'Ernesta', 'Initials': 'E', 'LastName': 'Audisio', 'Affiliation': 'Hematology Unit A.O.U. Città della Salute e della Scienza di Torino, 10126 Torino, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Terruzzi', 'Affiliation': 'Hematology Unit, Azienda Ospedaliera San Gerardo, 20900 Monza, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'De Paoli', 'Affiliation': 'Hematology Unit, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo, 15121 Alessandria, Italy.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Borlenghi', 'Affiliation': 'Hematology Unit, ASST-Spedali Civili, 25123, Brescia, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cavattoni', 'Affiliation': 'Hematology Unit, Ospedale S. Maurizio, 39100 Bolzano, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Mattei', 'Affiliation': 'Hematology Unit, Azienda Ospedaliera S.Croce e Carle di Cuneo, 12100 Cuneo, Italy.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Scattolin', 'Affiliation': ""Hematology Unit, Ospedale dell'Angelo and SS. Giovanni e Paolo, 30174 Venezia Mestre, Italy.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Tajana', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST) Ospedale di Cremona, 26100 Cremona, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Ciceri', 'Affiliation': 'Hematology Unit, IRCSS Ospedale San Raffaele, 20132 Milano, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Todisco', 'Affiliation': 'Hematology Unit, IRCCS Istituto Clinico Humanitas di Rozzano, 20089 Rozzano (MI), Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Campiotti', 'Affiliation': 'Medicine and Surgery Department, University of Insubria, 21100 Varese, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corradini', 'Affiliation': 'Hematology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, 20133 Milano, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Fracchiolla', 'Affiliation': ""Hematology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milano, Italy.""}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Bassan', 'Affiliation': ""Hematology Unit, Ospedale dell'Angelo and SS. Giovanni e Paolo, 30174 Venezia Mestre, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Rambaldi', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}, {'ForeName': 'Orietta', 'Initials': 'O', 'LastName': 'Spinelli', 'Affiliation': 'Hematology Unit, Azienda Socio Sanitaria Territoriale (ASST), Ospedale Papa Giovanni XXIII, 24127 Bergamo, Italy.'}]",Cancers,['10.3390/cancers12082242']
2110,32804282,Shoulder amplitude movement does not influence postoperative wound complications after breast cancer surgery: a randomized clinical trial.,"PURPOSE


The goal of this study is to evaluate the influence of shoulder exercises with restricted amplitude movement (RAM) or free amplitude movement (FAM) performed from the first postoperative day (1st POD) on the incidence of surgical wound complications (SWC) in breast cancer.
METHODS


This study comprises a randomized clinical trial with an intention-to-treat analysis including 465 women aged 18 to 79, who underwent curative surgery for breast cancer. Participants were submitted to perform free amplitude movement (FAM) or restricted amplitude movement (RAM) shoulder exercises, until the 30th postoperative day. The outcome measures were the SWC: seroma, dehiscence, necrosis, infection, hematoma and bruise.
RESULTS


461 participants completed the follow-up. Thirty days after surgery, 63.8% of the women presented some surgical wound complication, with necrosis (39.3%) and seroma (30.8%) as the most frequent. No statistically significant differences in SWC according to postoperative amplitude shoulder exercise (FAM vs RAM), even after a stratified analysis by type of surgery (segmentectomy vs mastectomy) or axillary approach (axillary lymphadenectomy versus sentinel lymph node biopsy) were observed.
CONCLUSION


FAM exercises do not increase the incidence of postoperative wound complications compared to RAM exercises.
TRIAL REGISTRATION


NCT03796845.",2020,"No statistically significant differences in SWC according to postoperative amplitude shoulder exercise (FAM vs RAM), even after a stratified analysis by type of surgery (segmentectomy vs mastectomy) or axillary approach (axillary lymphadenectomy versus sentinel lymph node biopsy) were observed.
","['breast cancer', '465 women aged 18 to 79, who underwent curative surgery for breast cancer', 'breast cancer surgery', '461 participants completed the follow-up']","['free amplitude movement (FAM) or restricted amplitude movement (RAM) shoulder exercises', 'FAM exercises', 'Shoulder amplitude movement', 'shoulder exercises with restricted amplitude movement (RAM) or free amplitude movement (FAM']","['postoperative wound complications', 'seroma', 'surgical wound complications (SWC', 'surgical wound complication, with necrosis', 'SWC: seroma, dehiscence, necrosis, infection, hematoma and bruise']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0454323', 'cui_str': 'Shoulder exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]","[{'cui': 'C0877305', 'cui_str': 'Postoperative wound complication'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0332803', 'cui_str': 'Surgical wound'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}]",465.0,0.162905,"No statistically significant differences in SWC according to postoperative amplitude shoulder exercise (FAM vs RAM), even after a stratified analysis by type of surgery (segmentectomy vs mastectomy) or axillary approach (axillary lymphadenectomy versus sentinel lymph node biopsy) were observed.
","[{'ForeName': 'Clarice Gomes Chagas', 'Initials': 'CGC', 'LastName': 'Teodózio', 'Affiliation': 'Clinical Research Division, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Liz de Oliveira', 'Initials': 'LO', 'LastName': 'Marchito', 'Affiliation': 'Clinical Research Division, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Erica Alves Nogueira', 'Initials': 'EAN', 'LastName': 'Fabro', 'Affiliation': 'Physiotherapy Department, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Flávia Oliveira', 'Initials': 'FO', 'LastName': 'Macedo', 'Affiliation': 'Physiotherapy Department, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Suzana Sales', 'Initials': 'SS', 'LastName': 'de Aguiar', 'Affiliation': 'Clinical Research Division, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Luiz Claudio Santos', 'Initials': 'LCS', 'LastName': 'Thuler', 'Affiliation': 'Clinical Research Division, Brazilian National Cancer Institute, Rio de Janeiro, Brazil.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Bergmann', 'Affiliation': 'Clinical Research Division, Brazilian National Cancer Institute, Rio de Janeiro, Brazil. abergmann@inca.gov.br.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05826-9']
2111,32804308,Improving cognitive mapping by training for people with a poor sense of direction.,"The skill of spatial learning and orientation is fundamental in humans and differs widely among individuals. Despite its importance, however, the malleability of this skill through practice has scarcely been studied empirically, in contrast to psychometric spatial ability. Thus, this article examines the possibility of improving the accuracy of configurational understanding of the environment by training. A total of 40 adults with a poor sense of direction participated in the experiment; and were randomly assigned to either a condition in which they received feedback only or a condition in which they additionally practiced allocentric spatial updating. Participants walked one route in each session, once a week for 6 weeks, and conducted spatial tasks designed to assess their knowledge of the route. A total of 20 people with an average sense of direction also participated as a comparison group. Results showed that training in allocentric spatial updating improved the accuracy of direction estimates, although the size of the effect was limited: the improvement was not large enough to equate the performance in the groups with a poor versus average sense of direction. The two groups, however, did not differ in spatial skill in mental rotation or path integration. Feedback was effective for improving accuracy in straight-line distance estimates and sketch maps: repeated trials with feedback led to improved accuracy by the sixth session to a level comparable to the group with an average sense of direction. The results show that flexible translation between viewer-centered and environment-centered representations is difficult and not readily trainable, and provide insights into the nature of individual differences in large-scale environmental cognition.",2020,Feedback was effective for improving accuracy in straight-line distance estimates and sketch maps: repeated trials with feedback led to improved accuracy by the sixth session to a level comparable to the group with an average sense of direction.,"['20 people with an\xa0average sense of direction also participated as a comparison group', '40 adults with a poor sense of direction participated in the experiment', 'people with a poor sense of direction']",['feedback only or a condition in which they additionally practiced allocentric spatial updating'],"['accuracy of direction estimates', 'spatial skill in mental rotation or path integration']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0522247', 'cui_str': 'Sense of direction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",40.0,0.0181052,Feedback was effective for improving accuracy in straight-line distance estimates and sketch maps: repeated trials with feedback led to improved accuracy by the sixth session to a level comparable to the group with an average sense of direction.,"[{'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'University of Tokyo, Tokyo, Japan. toru.ishikawa@iniad.org.'}, {'ForeName': 'Yiren', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'University of Tokyo, Tokyo, Japan.'}]",Cognitive research: principles and implications,['10.1186/s41235-020-00238-1']
2112,32804345,Effect of 1-year oral cholecalciferol on a metabolic profile and blood pressure in poor-controlled type 2 diabetes mellitus: an open-label randomized controlled pilot study.,"PURPOSE


Hypovitaminosis D has been associated with many cardio-metabolic disorders, although their pathogenetic link still remains unclear. Our aim was to evaluate whether 1-year vitamin D (D) supplementation could improve glycemic control, lipid profile, systolic (SBP) and diastolic (DBP) blood pressure levels and body composition.
METHODS


In an open-label randomized-controlled pilot study, thirty poor-controlled (HbA1c > 59 mmol/mol) type 2 diabetic patients (age 71.5 ± 3.2 years, M/F 21/9, BMI 29.8 ± 3.6 kg/m 2 ) with hypovitaminosis D (25OHD 22.0 ± 11.3 nmol/l) were randomized to cholecalciferol supplementation (500 UI/kg p.o. weekly, + D) or observation (- D) for one year. Changes in parameters of glucose, lipid and blood pressure control at 3, 6, 9 and 12 months vs. baseline were assessed.
RESULTS


One-year D supplementation restored D status and had a beneficial effect on fasting glucose (FG, mean percentage changes ± SD, - 1.8% ± 23.1 vs. + 18.8% ± 30.0), glycosylated haemoglobin (HbA1c, - 13.7% ± 14.5 vs. - 4.2% ± 14.1), SBP (- 13.4% ± 8.5 vs. - 2.4% ± 12.6) and HDL-cholesterol levels (- 2.1% ± 14.0 vs. - 10.9% ± 12.9; p < 0.05 for all comparisons) in + D vs. - D patients, respectively. In the former, a reduction in HBA1c, SBP and DBP levels, BMI, fat mass index (FMI) and ratio (FMR) was observed after 1 year (p < 0.05 for all comparisons vs. baseline). We noticed a relationship between 1-year mean percentage changes of serum 25OHD and SBP levels (R = - 0.36, p < 0.05).
CONCLUSION


One-year cholecalciferol supplementation, able to restore D status, significantly improves FG, HbA1c, SBP and HDL-cholesterol levels in patients with poor-controlled type 2 diabetes mellitus and D deficiency.",2020,"RESULTS


One-year D supplementation restored D status and had a beneficial effect on fasting glucose (FG, mean percentage changes ± SD, - 1.8% ± 23.1 vs. + 18.8% ± 30.0), glycosylated haemoglobin (HbA1c, - 13.7% ± 14.5 vs. - 4.2% ± 14.1), SBP (- 13.4% ± 8.5 vs. - 2.4% ± 12.6) and HDL-cholesterol levels (- 2.1% ± 14.0 vs. - 10.9% ± 12.9; p < 0.05 for all comparisons) in + D vs. - D patients, respectively.","['poor-controlled type 2 diabetes mellitus', 'thirty poor-controlled (HbA1c\u2009>\u200959\xa0mmol/mol) type 2 diabetic patients (age 71.5\u2009±\u20093.2\xa0years, M/F 21/9, BMI 29.8\u2009±\u20093.6\xa0kg/m 2 ) with hypovitaminosis D (25OHD 22.0\u2009±\u200911.3\xa0nmol/l', 'patients with poor-controlled type 2 diabetes mellitus and D deficiency']","['cholecalciferol supplementation', 'cholecalciferol', '1-year vitamin D (D) supplementation']","['HBA1c, SBP and DBP levels, BMI, fat mass index (FMI) and ratio (FMR', 'serum 25OHD and SBP levels', 'fasting glucose', 'glycosylated haemoglobin', 'glycemic control, lipid profile, systolic (SBP) and diastolic (DBP) blood pressure levels and body composition', 'metabolic profile and blood pressure', 'glucose, lipid and blood pressure control', 'HDL-cholesterol levels', 'FG, HbA1c, SBP and HDL-cholesterol levels', 'SBP']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517694', 'cui_str': '3.6'}, {'cui': 'C0035579', 'cui_str': 'Rickets'}, {'cui': 'C0439282', 'cui_str': 'nmol/L'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}]",30.0,0.0284998,"RESULTS


One-year D supplementation restored D status and had a beneficial effect on fasting glucose (FG, mean percentage changes ± SD, - 1.8% ± 23.1 vs. + 18.8% ± 30.0), glycosylated haemoglobin (HbA1c, - 13.7% ± 14.5 vs. - 4.2% ± 14.1), SBP (- 13.4% ± 8.5 vs. - 2.4% ± 12.6) and HDL-cholesterol levels (- 2.1% ± 14.0 vs. - 10.9% ± 12.9; p < 0.05 for all comparisons) in + D vs. - D patients, respectively.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Barale', 'Affiliation': 'Department of General and Specialty Medicine, Division of Endocrinology, Diabetology and Metabolic Diseases, Molinette Hospital, University of Turin - Cso Dogliotti, 14-10126, Turin, Italy. marco.barale@unito.it.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rossetto Giaccherino', 'Affiliation': 'Department of General and Specialty Medicine, Division of Endocrinology, Diabetology and Metabolic Diseases, Molinette Hospital, University of Turin - Cso Dogliotti, 14-10126, Turin, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ghigo', 'Affiliation': 'Department of General and Specialty Medicine, Division of Endocrinology, Diabetology and Metabolic Diseases, Molinette Hospital, University of Turin - Cso Dogliotti, 14-10126, Turin, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Procopio', 'Affiliation': 'Department of General and Specialty Medicine, Division of Endocrinology, Diabetology and Metabolic Diseases, Molinette Hospital, University of Turin - Cso Dogliotti, 14-10126, Turin, Italy.'}]",Journal of endocrinological investigation,['10.1007/s40618-020-01373-8']
2113,32804388,Intubation using the gum-elastic bougie while wearing personal protective equipment.,"OBJECTIVE


To determine whether application of a gum-elastic bougie (GEB), a visual stylet used to improve success rates of difficult intubations, reduces the time, and number of attempts to achieve successful intubation while wearing personal protective equipment (PPE).
DESIGN


A randomized cross-over study comparing orotracheal intubations performed on an AirMan® Mannequin, using either a semirigid stylet or a GEB, while wearing an active hood with a charcoal impregnated suit and butyl rubber gloves.
SETTING


Simulation training field of the Israel Defense Force Medical Corps.
PARTICIPANTS


27 military physicians and 23 paramedics (PMs).
INTERVENTIONS


Comparing intubation with and without using the GEB while wearing PPE.
MAIN OUTCOME MEASURE(S)


Airway (AW) control was considered successful if the ""lungs"" of the mannequin ex-panded during bag ventilation. Three unsuccessful attempts or a procedure exceeding 60 seconds were regarded as a failure. Correlations between parameters of self-assessment of skills and successful intubation were also determined.
RESULTS


With the GEB, success rate was lower (82 percent versus 100 percent, p = 0.002), more attempts were needed (1.4 ± 0.7 versus 1.0 ± 0.2, p = 0.005) and time-to-achieve AW control was longer (43.6 ± 14.6 sec-onds versus 23.1 ± 10.5 seconds, P < 0.001) than without it. Participants with high self-assessment of GEB-assisted AW management skills needed less attempts to perform successful intubation with GEB than participants with low self-assessment (1.0 ± 0.0 versus 1.4 ± 0.8, p = 0.001), but not less time to achieve it.
CONCLUSIONS


While donning PPE, the use of GEB (versus semirigid stylets) did not reduce the time or the number of attempts necessary to achieve successful intubation.",2020,"Participants with high self-assessment of GEB-assisted AW management skills needed less attempts to perform successful intubation with GEB than participants with low self-assessment (1.0 ± 0.0 versus 1.4 ± 0.8, p = 0.001), but not less time to achieve it.
",['27 military physicians and 23 paramedics (PMs'],"['semirigid stylet or a GEB, while wearing an active hood with a charcoal impregnated suit and butyl rubber gloves', 'gum-elastic bougie while wearing personal protective equipment', 'GEB', 'orotracheal intubations', 'gum-elastic bougie (GEB']","['time-to-achieve AW control', 'success rate']","[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}]","[{'cui': 'C0183663', 'cui_str': 'Stylet'}, {'cui': 'C1742512', 'cui_str': 'Gum elastic bougie'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0007955', 'cui_str': 'Charcoal'}, {'cui': 'C0054283', 'cui_str': 'butyl rubber'}, {'cui': 'C0206069', 'cui_str': 'Glove'}, {'cui': 'C1443871', 'cui_str': 'Personal protective equipment'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}]",,0.0333568,"Participants with high self-assessment of GEB-assisted AW management skills needed less attempts to perform successful intubation with GEB than participants with low self-assessment (1.0 ± 0.0 versus 1.4 ± 0.8, p = 0.001), but not less time to achieve it.
","[{'ForeName': 'Nadav', 'Initials': 'N', 'LastName': 'Milk', 'Affiliation': 'Israel Defense Forces Medical Corps, Ramat Gan, Israel.'}, {'ForeName': 'Yossi', 'Initials': 'Y', 'LastName': 'Rosman', 'Affiliation': 'Unit of Allergy and Clinical Immunology, Meir Medical Center, Kfar Saba, Israel; Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Nirit', 'Initials': 'N', 'LastName': 'Yavnai', 'Affiliation': 'Israel Defense Forces Medical Corps, Ramat Gan, Israel.'}, {'ForeName': 'Barak', 'Initials': 'B', 'LastName': 'Cohen', 'Affiliation': 'Division of Anesthesia, Intensive Care, and Pain Management, Tel-Aviv Medical Center, Tel-Aviv University, Tel-Aviv, Israel; Outcomes Research Consortium, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Nimrod', 'Initials': 'N', 'LastName': 'Ophir', 'Affiliation': 'Israel Defense Forces Medical Corps, Ramat Gan, Israel.'}, {'ForeName': 'Arik', 'Initials': 'A', 'LastName': 'Eisenkraft', 'Affiliation': 'Professor, Faculty of Medicine, Institute for Research in Military Medicine, The Hebrew University of Jeru-salem, Jerusalem, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kassirer', 'Affiliation': 'Israel Defense Forces Medical Corps, Ramat Gan, Israel.'}]",American journal of disaster medicine,['10.5055/ajdm.2020.0358']
2114,32798567,High Early Parenteral Lipid in Very Preterm Infants: A Randomized-Controlled Trial (HELP trial).,"OBJECTIVE


To determine whether high early parenteral soybean oil lipid intake in very low birth weight (VLBW) infants in the first week after birth decreases the proportion of weight loss and subsequently the incidence of extra-uterine growth restriction (EUGR).
STUDY DESIGN


This was a randomized controlled trial of appropriate-for-gestational-age VLBW infants. Lipid intake in the control group started at 0.5-1 g/kg per day and increased daily by 0.5-1 g/kg per day till reaching 3 g/kg per day. The intervention group was started on 2 g/kg per day which increased to 3 g/kg per day the following day.
RESULTS


Of the 176 infants assessed for eligibility, 83 were included in the trial. Infants in the intervention group were started on lipid sooner (13.8±7.8 vs 17.5±7.8 h; P= 0.03) and had higher cumulative lipid intake in the first 7 days of age (13.5±4.2 vs. 10.9±3.5 g/kg per day; P = .03). Infants in the intervention group had a lower percentage of weight loss (10.4 vs. 12.7%; P= 0.02). The mean triglyceride level was higher in the intervention group (1.91±0.79 vs. 1.49±0.54 mmol/L; P= 0.01), however, hypertriglyceridemia was similar between the two groups. The incidence of EUGR was lower in the intervention group (38.6% vs. 67.6%; P= 0.01). Head circumference Z-score was higher in the intervention group (-1.09±0.96 vs. -1.59±0.98; P= 0.04).
CONCLUSION


In VLBW infants, provision of a high early dose of parenteral lipid in the first week of age results in less weight loss and lower incidence of EUGR.",2020,"The mean triglyceride level was higher in the intervention group (1.91±0.79 vs. 1.49±0.54 mmol/L; P= 0.01), however, hypertriglyceridemia was similar between the two groups.","['Very Preterm Infants', '176 infants assessed for eligibility', 'gestational-age VLBW infants']",['high early parenteral soybean oil lipid intake'],"['weight loss and lower incidence of EUGR', 'cumulative lipid intake', 'lipid sooner', 'incidence of EUGR', 'hypertriglyceridemia', 'mean triglyceride level', 'Lipid intake', 'weight loss', 'Head circumference Z-score']","[{'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042149', 'cui_str': 'Uterine structure'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0262499', 'cui_str': 'Head circumference'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",176.0,0.102319,"The mean triglyceride level was higher in the intervention group (1.91±0.79 vs. 1.49±0.54 mmol/L; P= 0.01), however, hypertriglyceridemia was similar between the two groups.","[{'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Alburaki', 'Affiliation': 'Neonatal Nutritional and Gastroenterology Program, University of Calgary; University of Calgary.'}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Yusuf', 'Affiliation': 'University of Calgary.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Dobry', 'Affiliation': 'University of Calgary.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sheinfeld', 'Affiliation': 'University of Calgary.'}, {'ForeName': 'Belal', 'Initials': 'B', 'LastName': 'Alshaikh', 'Affiliation': 'Neonatal Nutritional and Gastroenterology Program, University of Calgary; University of Calgary. Electronic address: balshaik@ucalgary.ca.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.08.024']
2115,32798568,Effect of exercise and grape juice on epigenetic modulation and functional outcomes in PD: A randomized clinical trial.,"OBJECTIVE


This study aimed to investigate the impact of an aquatic physical training program associated with grape juice (Vitis labrusca) consumption on functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels in peripheral blood from individuals with Parkinson's disease.
METHODS


Nineteen participants were randomized to Aquatic Exercise (AQ, n = 9) and Aquatic Exercise + Grape Juice (AQ+GJ, n = 10) groups and performed to 4 weeks of an aquatic intervention (twice a week, approximately 60 min/session). The AQ+GJ groups also consumed 400 mL of grape juice per day during this period. Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS) were evaluated before and after intervention. In addition, blood collections were carried out for biomarker analysis (e.g. BDNF and global histone H4).
RESULTS


The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity. In addition, enhanced levels of BDNF and histone H4 acetylation were found after the intervention. Grape juice consumption did not potentiate these effects, since any significant differences between the AQ and AQ+GJ groups were not found in all analysed variables.
CONCLUSIONS


The present study provides important insights about aquatic exercise-modulated BDNF levels in individuals with Parkinson's disease in combination with functional improvements, suggesting that histone acetylation status may interact to dictate the molecular mechanisms involved in this response. Parkinson disease, aquatic exercise, BDNF, epigenetic, grape juice.",2020,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","['PD', ""individuals with Parkinson's disease"", ""peripheral blood from individuals with Parkinson's disease"", 'Nineteen participants']","['exercise and grape juice', 'AQ+GJ', 'aquatic exercise program', 'aquatic exercise-modulated BDNF levels', 'Aquatic Exercise (AQ, n=9) and Aquatic Exercise\u202f+\u202fGrape Juice (AQ+GJ, n=10) groups and performed to 4 weeks of an aquatic intervention', 'aquatic physical training program associated with grape juice (Vitis labrusca) consumption']","['functional outcomes, Brain-Derived Neurotrophic Factor (BDNF) and global histone H4 acetylation levels', 'enhanced levels of BDNF and histone H4 acetylation', 'Functional capacity (six-min walk test, 6MWT), mobility (The Timed Up and Go, TUG) and the risk of falls (Berg Balance Scale, BBS', 'epigenetic modulation and functional outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0452455', 'cui_str': 'Grape juice'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0949819', 'cui_str': 'Vitis'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0019648', 'cui_str': 'Histone H4'}, {'cui': 'C0001038', 'cui_str': 'Acetylation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1655731', 'cui_str': 'Epigenetic'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}]",19.0,0.0396303,"The aquatic exercise program induced functional improvement in individuals with Parkinson's disease, specifically ameliorating their mobility and functional capacity.","[{'ForeName': 'Grazielle Silva De', 'Initials': 'GS', 'LastName': 'Oliveira', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Iraci', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Gislaine Siqueira', 'Initials': 'GS', 'LastName': 'Pinheiro', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Marcela Zimmermann', 'Initials': 'MZ', 'LastName': 'Casal', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Aline Nogueira', 'Initials': 'AN', 'LastName': 'Haas', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pochmann', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil.'}, {'ForeName': 'Flavia Gomes', 'Initials': 'FG', 'LastName': 'Martinez', 'Affiliation': 'Laboratório de Pesquisa do Exercício, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Viviane', 'Initials': 'V', 'LastName': 'Elsner', 'Affiliation': 'Curso de Fisioterapia do Centro Universitário Metodista-IPA, Porto Alegre, RS-Brasil; Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil; Programa de Pós-Graduação em Ciências Biológicas: Fisiologia, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS-Brasil.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dani', 'Affiliation': 'Programa de Pós-Graduação em Biociências e Reabilitação do Centro Universitário Metodista -IPA. Rua Coronel Joaquim Pedro Salgado, 80 - Rio Branco, Porto Alegre - RS, CEP 90420-060, Brasil. Electronic address: carolinedani@yahoo.com.br.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113135']
2116,32798570,PERCEPTUAL RESPONSES: CLINICAL VERSUS PRACTICAL BLOOD FLOW RESTRICTION RESISTANCE EXERCISE.,"The purpose of the current investigation was to compare the acute perceptual responses during low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE), to determine if these responses differed between young males and females. Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2  and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design: 1) cBFR-RE, 2) pBFR-RE, 3) HL-RE, and 4) LL-RE. Low-load conditions consisted of 30-15-15-15 repetitions of two-leg press (LP) and knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE consisted of 3 sets of 10 repetitions at 80% 1-RM, all with 60s rest intervals. Ratings of perceived exertion (RPE) and discomfort were assessed before exercise and immediately following each set. RPE was significantly higher in HL-RE compared to all low-load conditions for both exercises after each set (all p<0.05). cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05). Levels of discomfort were similar between cBFR-RE and HL-RE, which tended to be significantly higher than pBFR-RE and LL-RE (p<0.05). Men reported significantly greater RPE than women following sets 2-4 during KE with cBFR-RE and sets 2 and 3 during KE for HL-RE (all p<0.05). Males also reported significantly greater discomfort than women following sets 2-4 for KE LL-RE (p<0.05). Altogether, these data suggest that pBFR-RE may provide a more favorable BFR condition based on perceptual responses and that perceptual responses may differ between sexes across varying resistance exercise conditions.",2020,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"['Twenty-nine participants (14 males: 23.6±2.7years, 25.3±3.1kg/m 2  and 15 females: 20.3±1.6years, 23.4±1.9kg/m 2 ) completed the following exercise conditions in a randomized design', 'young males and females']","['low-load resistance exercise (RE) with clinical blood flow restriction (cBFR-RE) and practical blood flow restriction (pBFR-RE), and during conventional low- (LL-RE) and high-load resistance exercise (HL-RE', 'knee extension (KE) exercises with 30% one-repetition maximum (1-RM), and HL-RE']","['Levels of discomfort', 'Ratings of perceived exertion (RPE) and discomfort', 'acute perceptual responses', 'discomfort', 'RPE']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0042950', 'cui_str': 'Volition'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}]",,0.0352726,cBFR-RE resulted in significantly greater RPE than pBFR-RE and LL-RE for both exercises for sets 1-4 for LP and sets 2-3 for KE (all p<0.05).,"[{'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Miller', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma. Electronic address: ryanmiller1@ou.edu.'}, {'ForeName': 'Bianca A R', 'Initials': 'BAR', 'LastName': 'Galletti', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma.'}, {'ForeName': 'Karolina J', 'Initials': 'KJ', 'LastName': 'Koziol', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma.'}, {'ForeName': 'Eduardo D S', 'Initials': 'EDS', 'LastName': 'Freitas', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma.'}, {'ForeName': 'Aaron D', 'Initials': 'AD', 'LastName': 'Heishman', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma; Department of Athletics, Basketball Strength and Performance, University of Oklahoma, Norman, Oklahoma.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Black', 'Affiliation': 'Department of Health and Exercise Science, Sensory and Muscle Function Research Laboratory, University of Oklahoma.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Larson', 'Affiliation': 'Departmeny of Health and Exercise Science, Sport, Health, and Exercise Data Analytics Laboratory, University of Oklahoma, Norman, Oklahoma.'}, {'ForeName': 'Debra A', 'Initials': 'DA', 'LastName': 'Bemben', 'Affiliation': 'Departmeny of Health and Exercise Science, Bone Density Research Laboratory, University of Oklahoma, Norman, Oklahoma.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Bemben', 'Affiliation': 'Department of Health and Exercise Science, Neuromuscular Research Laboratory, University of Oklahoma, Norman, Oklahoma.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113137']
2117,32798588,Anti-erosive Effect of Rinsing Before or After Toothbrushing with a Fluoride/stannous Ions Solution: an in situ investigation: Application order of Fluoride/Tin products for erosive tooth wear.,"OBJECTIVE


To evaluate the impact of the application of a F-/Sn2+-containing mouthrinse before or after toothbrushing with a F-/Sn2+/chitosan toothpaste on the progression of erosion/abrasion on enamel and dentin.
METHODS


This crossover in situ study had five arms: Control (toothbrushing without toothpaste), Brushing (toothbrushing with toothpaste), Brushing + Rinsing, Rinsing + Brushing, and Rinsing (without toothbrushing). Fifteen subjects used removable mandibular appliances containing 3 enamel and 3 dentin specimens, which were subjected to erosion-abrasion cycling of 60 min salivary pellicle formation followed by 5 min extra-oral erosion with 1% citric acid (4x/day for 5 days). Treatments were performed in situ after first and last erosive challenges with rinse (10 ml; 30 s) and/or toothbrushing with/without toothpaste (with electric toothbrush; 5 s per specimen; total 2 min contact with slurry). Surface loss (SL) was evaluated with an optical profilometer. Data were analyzed by two-way repeated measures ANOVA and Tukey tests (α = 0.05).
RESULTS


The Control showed the highest SL (mean ± SD for enamel: 24.58 ± 11.32; dentin: 32.32 ± 10.10; all µm). Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing. None of the arms that underwent toothbrushing with the toothpaste differed from each other (p > 0.05). Dentin specimens showed significantly higher SL values than enamel (p < 0.001).
CONCLUSION


The order of treatment applications had no influence on their anti-erosive effect; however, toothbrushing with F-/Sn2+/chitosan toothpaste reduced enamel surface loss. Additional rinsing with F-/Sn2+ mouthrinse did not offer improved protection.
CLINICAL SIGNIFICANCE


The use of fluoride- and stannous- containing toothpastes and mouthrinses is an important approach in the prevention of erosive tooth wear. Further evidence is needed to support the benefit of combining these products against this condition.",2020,"Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing.","['Fifteen subjects used removable mandibular appliances containing 3 enamel and 3 dentin specimens, which were subjected to']","['Rinsing', 'erosion-abrasion cycling of 60\u2009min salivary pellicle formation followed by 5\u2009min extra-oral erosion with 1% citric acid', 'fluoride- and stannous- containing toothpastes and mouthrinses', 'Fluoride/stannous Ions Solution', 'F-/Sn2+/chitosan toothpaste', 'F-/Sn2+ mouthrinse', 'Fluoride/Tin products', 'Control (toothbrushing without toothpaste), Brushing (toothbrushing with toothpaste), Brushing\u2009+\u2009Rinsing, Rinsing\u2009+\u2009Brushing, and Rinsing (without toothbrushing', 'toothbrushing with/without toothpaste (with electric toothbrush; 5\u2009s per specimen; total 2\u2009min contact with slurry', 'F-/Sn2+-containing mouthrinse']","['Surface loss (SL', 'progression of erosion/abrasion on enamel and dentin', 'protection', 'enamel surface loss', 'SL values', 'SL value']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C1292488', 'cui_str': 'Dentin specimen'}]","[{'cui': 'C1701810', 'cui_str': 'Rinse'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1257926', 'cui_str': 'Salivary Acquired Pellicle'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0040238', 'cui_str': 'Tin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer'}, {'cui': 'C0518443', 'cui_str': 'Abrasion and/or friction burn of skin'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0225144,"Rinsing alone resulted in significantly lower SL value (enamel: 8.30 ± 4.96; dentin: 16.15 ± 8.29) compared with arms that applied toothpaste, except Brushing + Rinsing.","[{'ForeName': 'Alana', 'Initials': 'A', 'LastName': 'Cristina Machado', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: alanam@usp.br.'}, {'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Oba Sakae', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: leticia.sakae@usp.br.'}, {'ForeName': 'Samira Helena', 'Initials': 'SH', 'LastName': 'JoÃo-Souza', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland. Electronic address: samira.joaosouza@gmail.com.'}, {'ForeName': 'Thiago Saads', 'Initials': 'TS', 'LastName': 'Carvalho', 'Affiliation': 'Department of Restorative, Preventive and Pediatric Dentistry, University of Bern, Freiburgstrasse 7 CH-3010, Bern, Switzerland. Electronic address: thiago.saads@zmk.univbe.ch.'}, {'ForeName': 'Bennett', 'Initials': 'B', 'LastName': 'Tochukwu Amaechi', 'Affiliation': 'Department of Comprehensive Dentistry, University of Texas Health Science Center of San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229, United States. Electronic address: amaechi@uthscsa.edu.'}, {'ForeName': 'Taís', 'Initials': 'T', 'LastName': 'Scaramucci', 'Affiliation': 'Department of Restorative Dentistry, University of São Paulo School of Dentistry. Av. Prof Lineu Prestes 2227, São Paulo 05508-000, SP, Brazil. Electronic address: tais.sca@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103450']
2118,32798834,The role of parental psychological flexibility in childhood asthma management: An analysis of cross-lagged panel models.,"OBJECTIVE


This is a secondary analysis of a previously reported randomized controlled trial, aimed at examining the mediating role of parental psychological flexibility (PF) in an Acceptance and Commitment Therapy (ACT)-based childhood asthma management program for parents.
METHODS


The participants were 168 parents (mean age (SD) = 38.40 (5.90) years; 88.1% mothers) and their children who had been diagnosed with asthma (mean age (SD) = 6.81 (2.50) years; 62% boys). They were randomly allocated to either the program composed of a four-session, group-based ACT plus asthma education (ACT Group) or to a group-based asthma education talk plus three telephone follow-ups (Control Group). The parents underwent assessments at baseline, and immediately, 3-months, and 6-months after the intervention for the following outcomes: PF (Acceptance and Action Questionnaire-II), psychological distress of the parents (Depression Anxiety Stress Scale-21); and the asthma symptoms and use of inhaled bronchodilators of their children.
RESULTS


Cross-lagged panel models showed that the improvement in parental PF at post-intervention mediated the effect of ACT on reducing parental psychological distress (all beta coefficients (βs) ranged from -2.20 to - 2.30, all Ps < 0.01) and childhood asthma symptoms in terms of daytime symptoms (β = -0.22, 95% CI [-0.52, -0.02], P = 0.04), nighttime symptoms (β = -0.17, 95% CI [-0.33, -0.02], P = 0.04), and the use of bronchodilators (β = -0.22, 95% CI [-0.48, -0.02], P = 0.03) at 6-months post-intervention.
CONCLUSION


ACT makes a unique contribution to improving the health outcomes of parents and their children diagnosed with asthma through fostering parental PF.",2020,"RESULTS


Cross-lagged panel models showed that the improvement in parental PF at post-intervention mediated the effect of ACT on reducing parental psychological distress (all beta coefficients (βs) ranged from -2.20 to - 2.30, all Ps < 0.01) and childhood asthma symptoms in terms of daytime symptoms (β = -0.22, 95% CI [-0.52, -0.02], P = 0.04), nighttime symptoms (β = -0.17, 95% CI [-0.33, -0.02], P = 0.04), and the use of bronchodilators (β = -0.22, 95% CI [-0.48, -0.02], P = 0.03) at 6-months post-intervention.
","['childhood asthma management', 'participants were 168 parents (mean age (SD)\u202f=\u202f38.40 (5.90) years; 88.1% mothers) and their children who had been diagnosed with asthma (mean age (SD)\u202f=\u202f6.81 (2.50) years; 62% boys', 'parents', 'parents and their children diagnosed with asthma through fostering parental PF']","['ACT plus asthma education (ACT Group) or to a group-based asthma education talk plus three telephone follow-ups (Control Group', 'ACT', 'parental psychological flexibility (PF', 'inhaled bronchodilators of their children']","['nighttime symptoms', 'childhood asthma symptoms', 'parental psychological distress', 'PF (Acceptance and Action Questionnaire-II), psychological distress of the parents (Depression Anxiety Stress Scale-21']","[{'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",168.0,0.118973,"RESULTS


Cross-lagged panel models showed that the improvement in parental PF at post-intervention mediated the effect of ACT on reducing parental psychological distress (all beta coefficients (βs) ranged from -2.20 to - 2.30, all Ps < 0.01) and childhood asthma symptoms in terms of daytime symptoms (β = -0.22, 95% CI [-0.52, -0.02], P = 0.04), nighttime symptoms (β = -0.17, 95% CI [-0.33, -0.02], P = 0.04), and the use of bronchodilators (β = -0.22, 95% CI [-0.48, -0.02], P = 0.03) at 6-months post-intervention.
","[{'ForeName': 'Yuen Yu', 'Initials': 'YY', 'LastName': 'Chong', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong. Electronic address: conniechong@cuhk.edu.hk.'}, {'ForeName': 'Yim Wah', 'Initials': 'YW', 'LastName': 'Mak', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}, {'ForeName': 'Alice Yuen', 'Initials': 'AY', 'LastName': 'Loke', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110208']
2119,32798835,"Effects of food-related behavioral activation therapy on eating styles, diet quality and body weight change: Results from the MooDFOOD Randomized Clinical Trial.","OBJECTIVE


Depression and obesity are bi-directionally related, eating styles and diet quality are two important factors associated with both. It remains uncertain if and how these two factors can be modified. Therefore the current study aims to investigate whether food-related behavioral activation therapy (F-BA), targeting mood, dietary habits and food related behavior, can improve eating styles, and diet quality and reduce body weight in adults with overweight or obesity and subsyndromal depressive symptoms.
METHODS


Data were derived from the MooDFOOD prevention trial, a 2x2 factorial RCT investigating the effect of nutritional strategies on prevention of depression. Changes in emotional, uncontrolled, and cognitive restrained eating (Three Factor Eating Questionnaire Revised), Mediterranean Diet Score (MDS), and body weight were analyzed among 1025 adults who either received F-BA or no intervention for 12 months. Intervention effect was tested by longitudinal analysis of covariance using mixed model analysis.
RESULTS


The F-BA group showed a small decrease in emotional (β=-5.68, p<.001) and uncontrolled eating (β=-4.05, p=.03), and increase in cognitive restrained eating (β=5.53, p<.01), compared to no F-BA. The effect of the F-BA therapy on emotional and uncontrolled eating was stronger in those with higher baseline depressive symptoms (IDS-SR). The F-BA did also lead to small improvements in MDS (β=1.95, p<.001), but not to change in body weight.
CONCLUSION


Our trial showed no reduction in bodyweight, but provides support for the possibility to improve both unhealthy eating styles and diet quality using an intervention targeting these specifically, although effects were small [Trial registration: clinicaltrials.gov NCT02529423].",2020,"The F-BA group showed a small decrease in emotional (β=-5.68, p<.001) and uncontrolled eating (β=-4.05, p=.03), and increase in cognitive restrained eating (β=5.53, p<.01), compared to no F-BA.","['adults with overweight or obesity and subsyndromal depressive symptoms', '1025 adults who either received']","['food-related behavioral activation therapy', 'F-BA therapy', 'F-BA or no intervention', 'food-related behavioral activation therapy (F-BA']","['Changes in emotional, uncontrolled, and cognitive restrained eating (Three Factor Eating Questionnaire Revised), Mediterranean Diet Score (MDS), and body weight', 'uncontrolled eating', 'emotional and uncontrolled eating', 'eating styles, and diet quality and reduce body weight', 'cognitive restrained eating', 'emotional', 'eating styles, diet quality and body weight change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0333779', 'cui_str': 'Reducing bodies'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",1025.0,0.112594,"The F-BA group showed a small decrease in emotional (β=-5.68, p<.001) and uncontrolled eating (β=-4.05, p=.03), and increase in cognitive restrained eating (β=5.53, p<.01), compared to no F-BA.","[{'ForeName': 'Nadine P G', 'Initials': 'NPG', 'LastName': 'Paans', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands. Electronic address: n.paans@ggzingeest.nl.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Bot', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Ingeborg A', 'Initials': 'IA', 'LastName': 'Brouwer', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health research institute, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Visser', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health research institute, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': ""Institut Universitari d' Investigació en Ciències de la Salut (IUNICS/IDISBA), Rediapp, University of Balearic Islands, Carretera de Valldemosssa km 7,5, 07071 Palma de Mallorca, Spain.""}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': ""Institut Universitari d' Investigació en Ciències de la Salut (IUNICS/IDISBA), Rediapp, University of Balearic Islands, Carretera de Valldemosssa km 7,5, 07071 Palma de Mallorca, Spain.""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hegerl', 'Affiliation': 'Department of Psychiatry, Psychosomatic and Psychotherapy, Senckenberg Distinguished Professorship, Goethe-University Frankfurt, Frankfurt A.M., Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kohls', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Leipzig, Medical Faculty, Leipzig, Germany.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Owens', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Watkins', 'Affiliation': 'Department of Psychology, University of Exeter, Exeter, UK.'}, {'ForeName': 'Brenda W J H', 'Initials': 'BWJH', 'LastName': 'Penninx', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110206']
2120,32798840,Mouse nerve growth factor promotes neurological recovery in patients with acute intracerebral hemorrhage: A proof-of-concept study.,"BACKGROUND


ew drugs were confirmed to be effective in the treatments of neurological dysfunction caused by acute intracerebral hemorrhage (ICH). The present prospective clinical trial aims to evaluate the effect of mouse nerve growth factor (mNGF) on neurological function in patients with acute ICH.
METHODS


60 patients with acute spontaneous ICH were randomized to receive mNGF (mNGF group) and citicoline (control group) for 4 weeks within 24-72 h after onset, respectively. The primary outcome was difference in the neurological functional outcome at 3 months by the modified Rankin Scale score (mRS). The secondary outcomes were the changes in hematoma volume at 4 weeks and 3 months.
RESULTS


There were 55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group). Among the patients, 46 patients finished the trial at 3 months; the odds of a shift towards death or dependence (mRS > 3) at 3 months in the mNGF group were lower than that in the control group with adjustment for age, sex, NIHSS at admission, and hematoma volume at admission (adjusted OR, 0.185; 95%CI, 0.059-0.582; P = 0.0039). The hematoma was gradually reduced in all 46 patients and absorbed after non-surgical treatment at 3 months. There was no significant difference in hematoma volume between the two groups. No serious adverse event was found.
CONCLUSIONS


The administration of mNGF and citicoline was well-tolerated in patients with acute ICH. mNGF was associated with improved neurological function and less disability in patients with ICH. Therefore, the quality of life of patients with ICH may be improved by mNGF.
TRIAL REGISTRATION


The trial is registered with the Chinese Clinical Trial Registry, number ChiCTR1800020258.",2020,There was no significant difference in hematoma volume between the two groups.,"['patients with acute ICH', 'patients with acute intracerebral hemorrhage', '55 patients receiving treatment (29 patients in the mNGF group, 26 patients in the control group', '60 patients with acute spontaneous ICH', 'patients with ICH']","['mNGF and citicoline', 'mNGF', 'mNGF (mNGF group) and citicoline (control group', 'mouse nerve growth factor (mNGF', 'Mouse nerve growth factor']","['quality of life', 'neurological functional outcome', 'hematoma', 'modified Rankin Scale score (mRS', 'changes in hematoma volume', 'neurological function', 'hematoma volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]","[{'cui': 'C0025914', 'cui_str': 'Mouse'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0027767', 'cui_str': 'Nervous system function'}]",60.0,0.0533032,There was no significant difference in hematoma volume between the two groups.,"[{'ForeName': 'Shuo', 'Initials': 'S', 'LastName': 'An', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Rehabilitation Medicine, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Yingsheng', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Shuyuan', 'Initials': 'S', 'LastName': 'Yue', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Yongyue', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Department of Biostatistics, Center for Global Health, School of Public Health, Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Lei', 'Affiliation': 'Laboratory of Neuro-Trauma and Neurodegenerative Disorders, Tianjin Geriatrics Institute, Tianjin Medical University General Hospital, Tianjin, China; Department of Geriatrics, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jianning', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jianningzhang@hotmail.com.'}, {'ForeName': 'Rongcai', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Key Laboratory of Post-Neurotrauma Neurorepair and Regeneration in Central Nervous System, Ministry of Education in China and Tianjin, Tianjin Neurological Institute, Tianjin, China; Department of Neurosurgery, Tianjin Medical University General Hospital, Tianjin, China. Electronic address: jiang116216@163.com.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.117069']
2121,32798927,A randomized controlled trial of 25 sessions comparing music therapy and music listening for children with autism spectrum disorder.,"BACKGROUND


Music therapy is based on the use of musical elements by a trained and qualified therapist. Clinical researches have suggested that children with Autism Spectrum Disorders (ASD) may benefit from MT. In this regard, this study examines if MT is more effective than simply listening to music for children with ASD.
METHOD


A 8-month RCT has been carried out comparing music therapy (MT) to music listening (ML) for children with ASD aged from 4 to 7 years old. Thirty-seven participants were randomly assigned to one of the two groups (MT vs. ML). The outcome measures were the Clinical Global Impression (CGI), the Childhood Autism Rating Scale (CARS) and the Aberrant Behavior Checklist (ABC) in each condition (MT and ML).
RESULTS


CGI scores decreased more for participants in the MT than in the ML condition. This clinical improvement was associated with an improvement of autistic symptoms on lethargy and stereotypy ABC subscales.
CONCLUSION


Our findings suggest that music therapy is more efficient than music listening for children with ASD. The present study thus supports the consideration of MT as a rightful add-on to ASD healthcare programs.",2020,"RESULTS


CGI scores decreased more for participants in the MT than in the ML condition.","['children with ASD', 'children with ASD aged from 4 to 7 years old', 'children with autism spectrum disorder', 'Thirty-seven participants', 'children with Autism Spectrum Disorders (ASD']","['MT', 'music therapy', 'music therapy and music listening', 'music therapy (MT) to music listening (ML']","['autistic symptoms on lethargy and stereotypy ABC subscales', 'Clinical Global Impression (CGI), the Childhood Autism Rating Scale (CARS) and the Aberrant Behavior Checklist (ABC) in each condition (MT and ML', 'CGI scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319569', 'cui_str': '37'}]","[{'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0038271', 'cui_str': 'Stereotyped routines'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",37.0,0.0933362,"RESULTS


CGI scores decreased more for participants in the MT than in the ML condition.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rabeyron', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France. Electronic address: thomas.rabeyron@univ-lorraine.fr.'}, {'ForeName': 'Juan-Pablo', 'Initials': 'JP', 'LastName': 'Robledo Del Canto', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France; Centre for Music and Science, University of Cambridge, United Kingdom.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Carasco', 'Affiliation': 'Institut de Musicothérapie, Université de Nantes, France.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Bisson', 'Affiliation': 'Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bodeau', 'Affiliation': 'Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}, {'ForeName': 'François-Xavier', 'Initials': 'FX', 'LastName': 'Vrait', 'Affiliation': 'Institut de Musicothérapie, Université de Nantes, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Berna', 'Affiliation': 'Université de Strasbourg, Hôpitaux Universitaires de Strasbourg, Inserm U1114, France; Collègue Universitaire des Médecines Intégratives et Complémentaires (CUMIC), Nantes, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bonnot', 'Affiliation': 'Laboratoire Interpsy, Psyclip, Université de Lorraine, France; Centre Hospitalo-Universitaire de Nantes, LPPL, France.'}]",Psychiatry research,['10.1016/j.psychres.2020.113377']
2122,32325004,Early Inspiratory Effort Assessment by Esophageal Manometry Predicts Noninvasive Ventilation Outcome in  De Novo  Respiratory Failure. A Pilot Study.,"Rationale:  The role of inspiratory effort still has to be determined as a potential predictor of noninvasive mechanical ventilation (NIV) failure in acute hypoxic  de novo  respiratory failure. Objectives:  To explore the hypothesis that inspiratory effort might be a major determinant of NIV failure in these patients. Methods:  Thirty consecutive patients with acute hypoxic  de novo  respiratory failure admitted to a single center and candidates for a 24-hour NIV trial were enrolled. Clinical features, tidal change in esophageal pressure (ΔPes), tidal change in dynamic transpulmonary pressure (ΔPl), expiratory Vt, and respiratory rate were recorded on admission and 2-4 to 12-24 hours after NIV start and were tested for correlation with outcomes. Measurements and Main Results:  ΔPes and ΔPes/ΔPl ratio were significantly lower 2 hours after NIV start in patients who successfully completed the NIV trial ( n  = 18) compared with those who needed endotracheal intubation ( n  = 12) (median [interquartile range], 11 [8-15] cm H 2 O vs. 31.5 [30-36] cm H 2 O;  P  < 0.0001), whereas other variables differed later. ΔPes was not related to other predictors of NIV failure at baseline. NIV-induced reduction in ΔPes of 10 cm H 2 O or more after 2 hours of treatment was strongly associated with avoidance of intubation and represented the most accurate predictor of treatment success (odds ratio, 15; 95% confidence interval, 2.8-110;  P  = 0.001 and area under the curve, 0.97; 95% confidence interval, 0.91-1;  P  < 0.0001). Conclusions:  The magnitude of inspiratory effort relief as assessed by ΔPes variation within the first 2 hours of NIV was an early and accurate predictor of NIV outcome at 24 hours.Clinical trial registered with www.clinicaltrials.gov (NCT03826797).",2020,"Measurements and Main Results:  ΔPes and ΔPes/ΔPl ratio were significantly lower 2 hours after NIV start in patients who successfully completed the NIV trial ( n  = 18) compared with those who needed endotracheal intubation ( n  = 12) (median [interquartile range], 11 [8-15] cm H 2 O vs. 31.5",['Thirty consecutive patients with acute hypoxic  de novo  respiratory failure admitted to a single center and candidates for a 24-hour NIV trial were enrolled'],[],"['Noninvasive Ventilation Outcome', 'ΔPes and ΔPes/ΔPl ratio', 'Clinical features, tidal change in esophageal pressure (ΔPes), tidal change in dynamic transpulmonary pressure (ΔPl), expiratory Vt, and respiratory rate']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0751673', 'cui_str': 'Nipah virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0232531', 'cui_str': 'Esophageal pressure'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0442377', 'cui_str': 'Transpulmonary artery approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",30.0,0.374853,"Measurements and Main Results:  ΔPes and ΔPes/ΔPl ratio were significantly lower 2 hours after NIV start in patients who successfully completed the NIV trial ( n  = 18) compared with those who needed endotracheal intubation ( n  = 12) (median [interquartile range], 11 [8-15] cm H 2 O vs. 31.5","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Tonelli', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Fantini', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Tabbì', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Castaniere', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Pisani', 'Affiliation': 'Department of Specialistic, Diagnostic and Experimental Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Pellegrino', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Della Casa', 'Affiliation': 'Radiology Unit and.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Statistics Unit, Department of Diagnostics, Clinical and Public Health Medicine, and.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Girardis', 'Affiliation': 'Intensive Care Unit, Department of Surgical, Medical, Dental and Morphological Sciences related to Transplants Oncology and Regenerative Medicine, University Hospital of Modena, University of Modena and Reggio Emilia, Modena, Italy; and.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Nava', 'Affiliation': 'Department of Specialistic, Diagnostic and Experimental Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Enrico M', 'Initials': 'EM', 'LastName': 'Clini', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Marchioni', 'Affiliation': 'Respiratory Diseases Unit, Department of Medical and Surgical Sciences.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201912-2512OC']
2123,32384051,Feasibility of the Internet Attachment-Based Compassion Therapy in the General Population: Protocol for an Open-Label Uncontrolled Pilot Trial.,"BACKGROUND


Compassion-based interventions delivered over the internet are showing promising results for the promotion of psychological health and well-being. Several studies have highlighted their feasibility, acceptance, and preliminary efficacy. However, this is an incipient field of research, and to the best of our knowledge, there are no data available from Spanish-speaking countries.
OBJECTIVE


The aim of this study is to investigate the feasibility, acceptance, and preliminary efficacy of the Internet Attachment-Based Compassion Therapy (iABCT), a web-based version of the Attachment-Based Compassion Therapy, in Spanish speakers from the general population.
METHODS


This feasibility study features a single-arm, uncontrolled, within-group design with an embedded qualitative and quantitative process evaluation at baseline, immediately after the intervention and at the 3-month follow-up. A minimum of 35 participants from the general population will be allocated to iABCT. Feasibility measures will include attrition rate, patterns of use of the web-based system, and participants' acceptability, usability, and opinion. The primary outcome was measured using the Pemberton Happiness Index. Secondary outcomes were measured using the Compassion Scale, Self-Compassion Scale, Forms of Self-Criticizing/Attacking and Self-Reassuring Scale-Short form, Five Facets of Mindfulness Questionnaire, Relationships Questionnaire, General Health Questionnaire, Non-Attachment Scale, International Positive and Negative Affect Schedule Short Form, Purpose-In-Life Test, and difficulties regarding the practice of compassion (Compassion Practice Quality Questionnaire). Mixed models will be used to evaluate primary and secondary outcome measures. A qualitative content analysis of the participants' qualitative responses will also be performed.
RESULTS


Enrollment started in February 2020 and will be finished in April 2020. Data analysis will start in October 2020.
CONCLUSIONS


To our knowledge, this study will, for the first time, show data on the feasibility, acceptability, and preliminary efficacy of web-based compassion (and self-compassion) training-that is, the adapted iABCT-in Spanish speakers from the general population. Further aspects of their implementation (ie, facilitators, barriers, and unwanted effects) and mechanisms of change will be investigated. This study will allow the revision and fine-tuning of the developed intervention, study design, and planning procedures, as well as the initiation of a future randomized controlled trial.
TRIAL REGISTRATION


Clinicaltrials.gov: NCT03918746. Registered on April 17, 2019. Protocol version 1, 6 March 2019.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/16717.",2020,"Secondary outcomes were measured using the Compassion Scale, Self-Compassion Scale, Forms of Self-Criticizing/Attacking and Self-Reassuring Scale-Short form, Five Facets of Mindfulness Questionnaire, Relationships Questionnaire, General Health Questionnaire, Non-Attachment Scale, International Positive and Negative Affect Schedule Short Form, Purpose-In-Life Test, and difficulties regarding the practice of compassion (Compassion Practice Quality Questionnaire).","['35 participants from the general population', 'Spanish speakers from the general population']","['Internet Attachment-Based Compassion Therapy', 'Internet Attachment-Based Compassion Therapy (iABCT']","['Compassion Scale, Self-Compassion Scale, Forms of Self-Criticizing/Attacking and Self-Reassuring Scale-Short form, Five Facets of Mindfulness Questionnaire, Relationships Questionnaire, General Health Questionnaire, Non-Attachment Scale, International Positive and Negative Affect Schedule Short Form, Purpose-In-Life Test, and difficulties regarding the practice of compassion (Compassion Practice Quality Questionnaire', ""attrition rate, patterns of use of the web-based system, and participants' acceptability, usability, and opinion"", 'Pemberton Happiness Index']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0557055', 'cui_str': 'Reassuring'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0451182', 'cui_str': 'General health questionnaire'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0582655', 'cui_str': 'Positive and negative affect schedule'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0034030', 'cui_str': 'Public Opinion'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.123296,"Secondary outcomes were measured using the Compassion Scale, Self-Compassion Scale, Forms of Self-Criticizing/Attacking and Self-Reassuring Scale-Short form, Five Facets of Mindfulness Questionnaire, Relationships Questionnaire, General Health Questionnaire, Non-Attachment Scale, International Positive and Negative Affect Schedule Short Form, Purpose-In-Life Test, and difficulties regarding the practice of compassion (Compassion Practice Quality Questionnaire).","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Campos', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón de la plana, Spain.'}, {'ForeName': 'Mayte', 'Initials': 'M', 'LastName': 'Navarro-Gil', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón (IISAragon), Zaragoza, Spain.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Herrera-Mercadal', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón (IISAragon), Zaragoza, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Martínez-García', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Ausiàs', 'Initials': 'A', 'LastName': 'Cebolla', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, Universitat de València, Valencia, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Borao', 'Affiliation': 'Department of Psychology and Sociology, University of Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'López-Del-Hoyo', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón (IISAragon), Zaragoza, Spain.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Castilla', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, Universitat de València, Valencia, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Del Río', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón de la plana, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'García-Campayo', 'Affiliation': 'Instituto de Investigación Sanitaria Aragón (IISAragon), Zaragoza, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Quero', 'Affiliation': 'Department of Basic and Clinical Psychology and Psychobiology, Universitat Jaume I, Castellón de la plana, Spain.'}]",JMIR research protocols,['10.2196/16717']
2124,32795086,"Dapagliflozin and Cardiac, Kidney and Limb Outcomes in Patients With and Without Peripheral Artery Disease in DECLARE-TIMI 58.","Background:  Patients with peripheral artery disease (PAD) are at heightened risk of cardiovascular complications. The SGLT2 inhibitor (SGLT2i) dapagliflozin reduces the risk for hospitalization for heart failure (HHF) and kidney events in patients with type 2 diabetes mellitus (T2DM). An increased risk of amputation has been observed with canagliflozin in one prior trial. We examined cardiovascular and kidney efficacy and the risk of limb related events in patients with and without peripheral artery disease (PAD) in an exploratory analysis.  Methods:  17,160 patients with T2DM, including 1,025 (6%) with PAD, were randomized. Key efficacy outcomes were MACE (CV Death, MI, stroke), CV Death/HHF, and progression of kidney disease. Amputations, peripheral revascularization and limb ischemic adverse events were site reported and categorized by a blinded reviewer.  Results:  Patients in the placebo arm with PAD versus those without tended to have higher adjusted risk of MACE (Adj HR 1.23, 95% CI 0.97 - 1.56, p=0.094) and significantly higher adjusted risk of CV Death/HHF (Adj HR 1.60, 95% CI 1.21 - 2.12, p=0.0010) and progression of kidney disease (Adj HR 1.51, 95% CI 1.13 - 2.03, p=0.0058). The relative risk reductions with dapagliflozin for CV Death/HHF (HR 0.86 PAD, HR 0.82 no-PAD, p-interaction 0.79) and progression of kidney disease (HR 0.78 PAD, HR 0.76 no-PAD, p-interaction 0.84) were consistent regardless of PAD. There were 560 patients who had at least one limb ischemic event, 454 patients with at least one peripheral revascularization, and 236 patients with at least one amputation with a total of 407 amputations reported. Overall, there were no significant differences in any limb outcome with dapagliflozin vs. placebo including limb ischemic adverse events (HR 1.07, 95% CI 0.90 - 1.26) and amputation (HR 1.09, 95% CI 0.84 - 1.40), with no significant interactions by a history of PAD vs. not (P interactions 0.30 and 0.093 respectively).  Conclusions:  Patients with versus without PAD are at higher risk of MACE, CV Death/HHF and kidney outcomes, and have consistent benefits for CV Death/HHF and progression of kidney disease with dapagliflozin. Patients with PAD had higher risk of limb events, with no consistent pattern of incremental risk observed with dapagliflozin.  Clinical Trial Registration:  AstraZeneca URL: http://www.clinicaltrials.gov Unique Identifier: NCT01730534.",2020,"Overall, there were no significant differences in any limb outcome with dapagliflozin vs. placebo including limb ischemic adverse events (HR 1.07, 95% CI 0.90 - 1.26) and amputation (HR 1.09, 95% CI 0.84 - 1.40), with no significant interactions by a history of PAD vs. not (P interactions 0.30 and 0.093 respectively).  ","['17,160 patients with T2DM, including 1,025 (6%) with PAD', 'Patients', '560 patients who had at least one limb ischemic event, 454 patients with at least one peripheral revascularization, and 236 patients with at least one amputation with a total of 407 amputations reported', 'patients with and without peripheral artery disease (PAD) in an exploratory analysis', 'patients with type 2 diabetes mellitus (T2DM', 'Patients with peripheral artery disease (PAD']","['SGLT2 inhibitor (SGLT2i) dapagliflozin', 'dapagliflozin vs. placebo', 'canagliflozin', 'placebo']","['Dapagliflozin and Cardiac, Kidney and Limb Outcomes', 'adjusted risk of CV Death/HHF', 'progression of kidney disease', 'MACE (CV Death, MI, stroke), CV Death/HHF, and progression of kidney disease', 'risk of MACE, CV Death/HHF and kidney outcomes', 'risk of limb events', 'Amputations, peripheral revascularization and limb ischemic adverse events', 'limb ischemic adverse events', 'adjusted risk of MACE', 'risk of amputation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4517782', 'cui_str': '454'}, {'cui': 'C1096418', 'cui_str': 'Peripheral revascularisation'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2974540', 'cui_str': 'canagliflozin'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C1096418', 'cui_str': 'Peripheral revascularisation'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",17160.0,0.184605,"Overall, there were no significant differences in any limb outcome with dapagliflozin vs. placebo including limb ischemic adverse events (HR 1.07, 95% CI 0.90 - 1.26) and amputation (HR 1.09, 95% CI 0.84 - 1.40), with no significant interactions by a history of PAD vs. not (P interactions 0.30 and 0.093 respectively).  ","[{'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA; University of Colorado School of Medicine, Aurora, CO.""}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Wiviott', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Zelniker', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA; Division of Cardiology, Vienna General Hospital, Medical University of Vienna, Vienna Austria.""}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Goodrich', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Remo Holanda De Mendonca', 'Initials': 'RHM', 'LastName': 'Furtado', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA; Hospital Albert Einstein and Instituto do Coracao da Faculdade de Medicina da USP, Sao Paulo, Brazil.""}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Avivit', 'Initials': 'A', 'LastName': 'Cahn', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Ingrid A M', 'Initials': 'IAM', 'LastName': 'Gause-Nilsson', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Johanson', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Fredriksson', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Johansson', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Hadassah Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital Heart and Harvard Medical School, Boston, MA.""}]",Circulation,['10.1161/CIRCULATIONAHA.119.044775']
2125,32795282,Acceptability of telephone-based pain coping skills training among African Americans with osteoarthritis enrolled in a randomized controlled trial: a mixed methods analysis.,"BACKGROUND


Osteoarthritis (OA) disproportionately impacts African Americans compared to Caucasians, including greater pain severity. The Pain Coping Skills Training for African Americans with Osteoarthritis (STAART) study examined a culturally enhanced Pain Coping Skills Training (CST) program among African Americans with OA. This mixed methods study evaluated the acceptability of the Pain CST program among STAART participants.
METHODS


STAART was a randomized controlled trial evaluating the effectiveness of an 11-session, telephone-based pain CST program, compared to a usual care control group. Participants were from the University of North Carolina and Durham Veterans Affairs Healthcare Systems. The present analyses included 93 participants in the CST group who completed a questionnaire about experiences with the program. Descriptive statistics of the questionnaire responses were calculated using SAS software. Thematic analysis was applied to open-response data using Dedoose software.
RESULTS


Participants' mean rating of overall helpfulness of the pain CST program for managing arthritis symptoms was 8.0 (SD = 2.2) on a scale of 0-10. A majority of participants reported the program made a positive difference in their experience with arthritis (83.1%). Mean ratings of helpfulness of the specific skills ranged from 7.7 to 8.8 (all scales 0-10). Qualitative analysis of the open-response data identified four prominent themes: Improved Pain Coping, Mood and Emotional Benefits, Improved Physical Functioning, and experiences related to Intervention Delivery.
CONCLUSIONS


The high ratings of helpfulness demonstrate acceptability of this culturally enhanced pain CST program by African Americans with OA. Increasing access to cognitive-behavioral therapy-based programs may be a promising strategy to address racial disparities in OA-related pain and associated outcomes.
TRIAL REGISTRATION


NCT02560922 , registered September 25, 2015.",2020,The Pain Coping Skills Training for African Americans with Osteoarthritis (STAART) study examined a culturally enhanced Pain Coping Skills Training (CST) program among African Americans with OA.,"['African Americans with osteoarthritis enrolled', 'African Americans with OA', 'African Americans with Osteoarthritis (STAART', 'Participants were from the University of North Carolina and Durham Veterans Affairs Healthcare Systems', '93 participants in the CST group who completed a questionnaire about experiences with the program', 'STAART participants']","['11-session, telephone-based pain CST program', 'telephone-based pain coping skills training', 'culturally enhanced Pain Coping Skills Training (CST) program', 'Pain Coping Skills Training']","['Pain Coping, Mood and Emotional Benefits, Improved Physical Functioning, and experiences related to Intervention Delivery', 'mean rating of overall helpfulness of the pain CST program for managing arthritis symptoms', 'Mean ratings of helpfulness of the specific skills']","[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0454851', 'cui_str': 'Durham'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0729375', 'cui_str': 'Coping skills training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.0433981,The Pain Coping Skills Training for African Americans with Osteoarthritis (STAART) study examined a culturally enhanced Pain Coping Skills Training (CST) program among African Americans with OA.,"[{'ForeName': 'Chamara J', 'Initials': 'CJ', 'LastName': 'Dharmasri', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Griesemer', 'Affiliation': 'Department of Health Behavior, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Liubov', 'Initials': 'L', 'LastName': 'Arbeeva', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Lisa C', 'Initials': 'LC', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychology, East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Crystal W', 'Initials': 'CW', 'LastName': 'Cené', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University, Durham, NC, USA.'}, {'ForeName': 'Eugene Z', 'Initials': 'EZ', 'LastName': 'Oddone', 'Affiliation': 'Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health System, Durham, NC, USA.'}, {'ForeName': 'Tamara J', 'Initials': 'TJ', 'LastName': 'Somers', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Duke University, Durham, NC, USA.'}, {'ForeName': 'Kelli D', 'Initials': 'KD', 'LastName': 'Allen', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, USA. kdallen@email.unc.edu.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03578-7']
2126,32795283,Rationale and design of the PaTIO study: PhysiotherApeutic Treat-to-target Intervention after Orthopaedic surgery.,"BACKGROUND


Physiotherapy is a proven effective treatment strategy after total knee and hip arthroplasty (TKA/THA), however there is considerable practice variation regarding its timing, content and duration. This study aims to compare the (cost-) effectiveness of a standardized, treat-to-target postoperative physiotherapy strategy with usual postoperative care.
METHODS


Using a cluster randomized study design, consecutive patients scheduled for a primary TKA/THA in 18 hospitals in the Netherlands will be assigned to the treat-to-target physio therapy strategy or usual postoperative care. With the treat-to-target strategy a standardized, individually tailored, exercise program is aimed at the attainment of specific functional milestones. Assessments are done at baseline, 6 weeks and 3, 6, 9 and 12 months follow up. The primary outcome will be the Knee injury / Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS / HOOS-PS) at 3 months follow up. Secondary outcomes are the numeric rating scale for pain, the Oxford Knee and Hip Scores, performance-based test and the EuroQol 5D-5L for quality of life. Healthcare use, productivity and satisfaction with postoperative care are measured by means of questionnaires. In total, 624 patients will be needed of which 312 TKA and 312 THA patients.
DISCUSSION


The study will provide evidence concerning the (cost-) effectiveness of the treat-to-target postoperative physiotherapy treatment compared to usual postoperative care. The results of this study will address an important evidence gap and will have a significant impact in daily practice of the physio therapist.
TRIAL REGISTRATION


Registered in the Dutch Trial Registry on April 15, 2018. Registration number: NTR7129 .",2020,"BACKGROUND


Physiotherapy is a proven effective treatment strategy after total knee and hip arthroplasty","['total knee and hip arthroplasty', '624 patients will be needed of which 312 TKA and 312 THA patients', 'consecutive patients scheduled for a primary TKA/THA in 18 hospitals in the Netherlands will be assigned to the treat-to-target physio therapy strategy or usual postoperative care']",[],"['Knee injury / Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form (KOOS-PS / HOOS-PS', 'Healthcare use, productivity and satisfaction with postoperative care', 'numeric rating scale for pain, the Oxford Knee and Hip Scores, performance-based test and the EuroQol 5D-5L for quality of life']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0039245', 'cui_str': 'Tacrine'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032786', 'cui_str': 'Postoperative care'}]",[],"[{'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C2960303', 'cui_str': 'Hip disability and osteoarthritis outcome score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0032786', 'cui_str': 'Postoperative care'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",624.0,0.158489,"BACKGROUND


Physiotherapy is a proven effective treatment strategy after total knee and hip arthroplasty","[{'ForeName': 'Lichelle', 'Initials': 'L', 'LastName': 'Groot', 'Affiliation': 'Department of Orthopedic Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, Netherlands. L.Groot@erasmusmc.nl.'}, {'ForeName': 'Maaike G J', 'Initials': 'MGJ', 'LastName': 'Gademan', 'Affiliation': 'Department of Orthopedic Surgery, LUMC, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Wilfred F', 'Initials': 'WF', 'LastName': 'Peter', 'Affiliation': 'Department of Orthopedic Surgery, LUMC, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Wilbert B', 'Initials': 'WB', 'LastName': 'van den Hout', 'Affiliation': 'Department of Medical Decision Making & Quality of Care, LUMC, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Hennie', 'Initials': 'H', 'LastName': 'Verburg', 'Affiliation': 'Department of Orthopedic Surgery, Reinier de Graaf Hospital, Reinier de Graafweg 5, 2625 AD, Delft, The Netherlands.'}, {'ForeName': 'Thea P M', 'Initials': 'TPM', 'LastName': 'Vliet Vlieland', 'Affiliation': 'Department of Orthopedic Surgery, LUMC, Leiden University Medical Center, P.O. Box 9600, 2300 RC, Leiden, The Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Reijman', 'Affiliation': 'Department of Orthopedic Surgery, Erasmus MC, University Medical Center Rotterdam, P.O. Box 2040, 3000 CA, Rotterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03511-y']
2127,32795284,Ipilimumab plus nivolumab and chemoradiotherapy followed by surgery in patients with resectable and borderline resectable T3-4N0-1 non-small cell lung cancer: the INCREASE trial.,"BACKGROUND


The likelihood of a tumor recurrence in patients with T3-4N0-1 non-small cell lung cancer following multimodality treatment remains substantial, mainly due distant metastases. As pathological complete responses (pCR) in resected specimens are seen in only a minority (28-38%) of patients following chemoradiotherapy, we designed the INCREASE trial (EudraCT-Number: 2019-003454-83; Netherlands Trial Register number: NL8435) to assess if pCR rates could be further improved by adding short course immunotherapy to induction chemoradiotherapy. Translational studies will correlate changes in loco-regional and systemic immune status with patterns of recurrence.
METHODS/DESIGN


This single-arm, prospective phase II trial will enroll 29 patients with either resectable, or borderline resectable, T3-4N0-1 NSCLC. The protocol was approved by the institutional ethics committee. Study enrollment commenced in February 2020. On day 1 of guideline-recommended concurrent chemoradiotherapy (CRT), ipilimumab (IPI, 1 mg/kg IV) and nivolumab (NIVO, 360 mg flat dose IV) will be administered, followed by nivolumab (360 mg flat dose IV) after 3 weeks. Radiotherapy consists of once-daily doses of 2 Gy to a total of 50 Gy, and chemotherapy will consist of a platinum-doublet. An anatomical pulmonary resection is planned 6 weeks after the last day of radiotherapy. The primary study objective is to establish the safety of adding IPI/NIVO to pre-operative CRT, and its impact on pathological tumor response. Secondary objectives are to assess the impact of adding IPI/NIVO to CRT on disease free and overall survival. Exploratory objectives are to characterize tumor inflammation and the immune contexture in the tumor and tumor-draining lymph nodes (TDLN), and to explore the effects of IPI/NIVO and CRT and surgery on distribution and phenotype of peripheral blood immune subsets.
DISCUSSION


The INCREASE trial will evaluate the safety and local efficacy of a combination of 4 modalities in patients with resectable, T3-4N0-1 NSCLC. Translational research will investigate the mechanisms of action and drug related adverse events.
TRIAL REGISTRATION


Netherlands Trial Registration (NTR): NL8435 , Registered 03 March 2020.",2020,"The INCREASE trial will evaluate the safety and local efficacy of a combination of 4 modalities in patients with resectable, T3-4N0-1 NSCLC.","['patients with T3-4N0-1 non-small cell lung cancer', 'patients with resectable, T3-4N0-1 NSCLC', 'patients with resectable and borderline resectable T3-4N0-1 non-small cell lung cancer', '29 patients with either resectable, or borderline resectable, T3-4N0-1 NSCLC']","['guideline-recommended concurrent chemoradiotherapy (CRT), ipilimumab (IPI, 1\u2009mg/kg IV) and nivolumab (NIVO', 'Ipilimumab plus nivolumab and chemoradiotherapy', 'Radiotherapy']","['impact of adding IPI/NIVO to CRT on disease free and overall survival', 'safety and local efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0668760', 'cui_str': 'diinosine pentaphosphate'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0668760', 'cui_str': 'diinosine pentaphosphate'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",29.0,0.329677,"The INCREASE trial will evaluate the safety and local efficacy of a combination of 4 modalities in patients with resectable, T3-4N0-1 NSCLC.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Dickhoff', 'Affiliation': 'Department of Surgery and Cardiothoracic Surgery, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands. c.dickhoff@amsterdamumc.nl.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Senan', 'Affiliation': 'Department of Radiation Oncology, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Famke L', 'Initials': 'FL', 'LastName': 'Schneiders', 'Affiliation': 'Department of Radiation Oncology, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Veltman', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam University Medical Center, location VUmcCancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Sayed', 'Initials': 'S', 'LastName': 'Hashemi', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam University Medical Center, location VUmcCancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes M A', 'Initials': 'JMA', 'LastName': 'Daniels', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam University Medical Center, location VUmcCancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Fransen', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam University Medical Center, location VUmcCancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Heineman', 'Affiliation': 'Department of Surgery and Cardiothoracic Surgery, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Radonic', 'Affiliation': 'Department of Pathology, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Imke H', 'Initials': 'IH', 'LastName': 'Bartelink', 'Affiliation': 'Department of Clinical Pharmacology and Pharmacy, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Lilian J', 'Initials': 'LJ', 'LastName': 'Meijboom', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Garcia-Vallejo', 'Affiliation': 'Department of Molecular Cell Biology & Immunology, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Daniela E', 'Initials': 'DE', 'LastName': 'Oprea-Lager', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Tanja D', 'Initials': 'TD', 'LastName': 'de Gruijl', 'Affiliation': 'Department of Medical Oncology, Amsterdam University Medical Center, location VUmc, Cancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}, {'ForeName': 'Idris', 'Initials': 'I', 'LastName': 'Bahce', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam University Medical Center, location VUmcCancer Center Amsterdam, de Boelelaan 1117, 1081HV, Amsterdam, the Netherlands.'}]",BMC cancer,['10.1186/s12885-020-07263-9']
2128,32795294,Dietary habits and metabolic response improve in obese children whose mothers received an intervention to promote healthy eating: randomized clinical trial.,"BACKGROUND


Lifestyles habits such as eating unhealthy foodscommence at home and are associated with the development of obesity and comorbidities such as insulin resistance, metabolic syndrome, and chronic degenerative diseases, which are the main causes of death in adults. The present study compared changes in dietary habits, behaviors and metabolic profiles of obese children whose mothers attended at the hospital to group sessions, with those who received the usual nutritional consultation.
METHODS


Randomized clinical trial, 177 mother/obese child pairs participated, 90 in the intervention group and 87 in the control group. The intervention group attended six group education sessions to promote healthy eating, being this an alternative of change of habits in children with obesity. The control group received the usual nutritional consultation; both groups were followed up for 3 months. Frequency of food consumption, behaviors during feeding in the house and metabolic profile was evaluated. Mixed effect linear regression models were used to evaluate the effect of the intervention on the variables of interest, especially in HOMA-IR.
RESULTS


The intervention group reduced the filling of their dishes (p = 0.009), forcing the children to finish meals (p = 0.003) and food substitution (p <  0.001), moreover increased the consumption of roasted foods (p = 0.046), fruits (p = 0.002) and vegetables (p <  0.001). The children in the control group slightly increased HOMA-IR levels (0.51; 95% CI - 0.48 to 1.50), while the children in the intervention group significantly decreased (- 1.22; 95% CI - 2.28 to - 1.16). The difference in HOMA-IR between the control and intervention group at the end of the follow-up was - 1.67; 95% CI: - 3.11 to - 0.24.
CONCLUSIONS


The educational intervention improved some eating habits at home, as well as HOMA-IR levels; why we consider that it can be an extra resource in the management of childhood obesity.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT04374292 (Date assigned: May 5, 2020). Retrospectively registered.",2020,"The children in the control group slightly increased HOMA-IR levels (0.51; 95% CI - 0.48 to 1.50), while the children in the intervention group significantly decreased (- 1.22; 95% CI - 2.28 to - 1.16).","['children with obesity', 'obese children', 'obese children whose mothers attended at the hospital to group sessions, with those who received the usual nutritional consultation', '177 mother/obese child pairs participated, 90 in the intervention group and 87 in the control group']","['intervention group attended six group education sessions to promote healthy eating', 'educational intervention', 'usual nutritional consultation']","['eating habits', 'HOMA-IR', 'Dietary habits and metabolic response', 'HOMA-IR levels', 'consumption of roasted foods', 'filling of their dishes', 'dietary habits, behaviors and metabolic profiles']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0020498', 'cui_str': 'Disseminated idiopathic skeletal hyperostosis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}]",177.0,0.0567629,"The children in the control group slightly increased HOMA-IR levels (0.51; 95% CI - 0.48 to 1.50), while the children in the intervention group significantly decreased (- 1.22; 95% CI - 2.28 to - 1.16).","[{'ForeName': 'Iris Nallely', 'Initials': 'IN', 'LastName': 'López-Contreras', 'Affiliation': 'Gastroenterology and Nutrition Department, Hospital Infantil de México Federico Gómez, Ministry of Health (SSA), Mexico City, Mexico.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Vilchis-Gil', 'Affiliation': 'Epidemiological Research Unit in Endocrinology and Nutrition, Hospital Infantil de México Federico Gomez, Ministry of Health (SSA), Dr. Márquez No 162, 06720, Mexico City, Mexico.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Klünder-Klünder', 'Affiliation': 'Deputy Director of Research, Hospital Infantil de México Federico Gómez, Ministry of Health (SSA), Mexico City, Mexico.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Villalpando-Carrión', 'Affiliation': 'Gastroenterology and Nutrition Department, Hospital Infantil de México Federico Gómez, Ministry of Health (SSA), Mexico City, Mexico.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Flores-Huerta', 'Affiliation': 'Epidemiological Research Unit in Endocrinology and Nutrition, Hospital Infantil de México Federico Gomez, Ministry of Health (SSA), Dr. Márquez No 162, 06720, Mexico City, Mexico. floreshuertamd@gmail.com.'}]",BMC public health,['10.1186/s12889-020-09339-4']
2129,32795381,Health TAPESTRY Ontario: protocol for a randomized controlled trial to test reproducibility and implementation.,"BACKGROUND


Health TAPESTRY (Health Teams Advancing Patient Experience: STRengthening qualitY) aims to help people stay healthier for longer where they live by providing person-focused care through the integration of four key program components: (1) trained volunteers who visit clients in their homes, (2) an interprofessional primary health care team, (3) use of technology to collect and share information, and (4) improved connections to community health and social services. The initial randomized controlled trial of Health TAPESTRY found promising results in terms of health care use and patient outcomes, indicating a shift from reactive to preventive care. The trial was based on one clinical academic center, thus limiting generalizability. The study objectives are (1) to test reproducibility of the established effectiveness of Health TAPESTRY on physical activity and hospitalizations, (2) to test the feasibility of, and understand the contributing factors to, the implementation of Health TAPESTRY in six diverse communities across Ontario, Canada, and (3) to determine the value for money of implementing Health TAPESTRY.
METHODS


This planned study is a pragmatic parallel randomized controlled trial with a delayed intervention for control participants at 6 months. This trial will simultaneously assess effectiveness and implementation in a real-world setting (type II hybrid) in six diverse communities across Ontario. Participants 70 years of age and older will be randomized into the Health TAPESTRY intervention or the control group (usual care). Intervention clients will receive an individualized plan of care from an interprofessional care team. The plan will be based on a client's goals and current health risks identified through volunteer visits. The study's outcomes are mapped onto the RE-AIM framework, with levels of physical activity and number of hospitalizations as the co-primary outcomes. The main analysis will be a comparison at 6 months.
DISCUSSION


It is important to evaluate the effectiveness and implementation of Health TAPESTRY in multiple communities prior to scaling or widespread adoption.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03397836 . Registered on 12 January 2018.",2020,Participants 70 years of age and older will be randomized into the Health TAPESTRY intervention or the control group (usual care).,"['Participants 70\u2009years of age and older', 'control participants at 6\xa0months', 'Health Teams Advancing Patient Experience', 'six diverse communities across Ontario']","['interprofessional primary health care team, (3) use of technology to collect and share information, and (4) improved connections to community health and social services', 'Health TAPESTRY', 'Health TAPESTRY intervention or the control group (usual care']",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}]","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.108994,Participants 70 years of age and older will be randomized into the Health TAPESTRY intervention or the control group (usual care).,"[{'ForeName': 'Dee', 'Initials': 'D', 'LastName': 'Mangin', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 5th floor, Hamilton, ON, L8P 1H6, Canada. mangind@mcmaster.ca.'}, {'ForeName': 'Larkin', 'Initials': 'L', 'LastName': 'Lamarche', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 5th floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Oliver', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 3rd floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Sivan', 'Initials': 'S', 'LastName': 'Bomze', 'Affiliation': 'Canadian Red Cross, 5700 Cancross Court, Mississauga, ON, L5R 3E9, Canada.'}, {'ForeName': 'Sayem', 'Initials': 'S', 'LastName': 'Borhan', 'Affiliation': 'Department of Family Medicine, and Department of Health Research Methods, Evidence and Impact McMaster University, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Browne', 'Affiliation': 'Canadian Red Cross, 1460 Fairburn Street, Sudbury, ON, P3A 1N7, Canada.'}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Carr', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 6th floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Datta', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 6th floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dolovich', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 5th floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Howard', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 5th floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Marentette-Brown', 'Affiliation': 'Canadian Red Cross, 5700 Cancross Court, Mississauga, ON, L5R 3E9, Canada.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Risdon', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 6th floor, Hamilton, ON, L8P 1H6, Canada.'}, {'ForeName': 'Samina', 'Initials': 'S', 'LastName': 'Talat', 'Affiliation': 'Canadian Red Cross, 5700 Cancross Court, Mississauga, ON, L5R 3E9, Canada.'}, {'ForeName': 'Jean-Eric', 'Initials': 'JE', 'LastName': 'Tarride', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Programs for Assessment of Technologies in Health and Center for Health Economics and Policy Analysis, CRL 227, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Programs for Assessment of Technologist in Health, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Valaitis', 'Affiliation': 'School of Nursing, McMaster University, Health Sciences Centre, 1280 Main Street West, Hamilton, ON, L8S 4L8, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Price', 'Affiliation': 'Department of Family Medicine, McMaster University, David Braley Health Sciences Centre, 100 Main Street West, 6th floor, Hamilton, ON, L8P 1H6, Canada.'}]",Trials,['10.1186/s13063-020-04600-y']
2130,32795428,Levonorgestrel releasing intrauterine system versus endometrial ablation for heavy menstrual bleeding.,"BACKGROUND


Heavy menstrual bleeding affects the physical functioning and social well-being of many women. The levonorgestrel intrauterine system and endometrial ablation are two frequently applied treatments in women with heavy menstrual bleeding.
OBJECTIVE


The objective of this study is to compare the effectiveness of the levonorgestrel intrauterine system to endometrial ablation in women with heavy menstrual bleeding.
STUDY DESIGN


This multicenter randomized controlled non-inferiority trial was performed in 26 hospitals and in a network of general practices in the Netherlands. Women with heavy menstrual bleeding, aged 34 and older, without a pregnancy wish or intracavitary pathology were randomly allocated to treatment with either the levonorgestrel intrauterine system (Mirena) or to endometrial ablation, performed with the bipolar radiofrequency device (NovaSure). The primary outcome was blood loss at 24 months, measured with a Pictorial Blood Assessment Chart (PBAC)-score. Secondary outcomes included re-intervention rates, patient satisfaction, quality of life, and sexual function.
RESULTS


We registered 645 women as eligible of whom 270 women provided informed consent. Of these, 132 women were allocated to the levonorgestrel intrauterine system (baseline PBAC-score 616) and 138 women to endometrial ablation (baseline PBAC-score 630). At 24 months, mean PBAC-scores were 64.8 in the levonorgestrel intrauterine system group and 14.2 in the endometrial ablation group (difference 50.5 points, 95% CI 4.3 to 96.7, non-inferiority P=0.87 (25 PBAC-points margin)). In the levonorgestrel intrauterine system group 49 women (39%) removed the intrauterine system and 34 women (27%) underwent a surgical re-intervention, compared to 14 women (10%) in the endometrial ablation group (RR 2.64, 95% CI 1.49 to 4.68). There was no significant difference in patient satisfaction and quality of life between the groups.
CONCLUSIONS


Both the levonorgestrel intrauterine system and endometrial ablation strategy lead to a large decrease in menstrual blood loss in women with heavy menstrual bleeding, with comparable quality of life scores after treatment. Nevertheless, there was a significant difference in menstrual blood loss in favor of endometrial ablation, and we could not demonstrate non-inferiority of starting with the levonorgestrel intrauterine system. Women who start with the levonorgestrel intrauterine system, a reversible and less invasive treatment, are at increased risk of needing additional treatment, compared to women who start with endometrial ablation. The results of this study will enable physicians to provide women with heavy menstrual bleeding with the evidence to make a well-informed decision between the two treatments.",2020,"At 24 months, mean PBAC-scores were 64.8 in the levonorgestrel intrauterine system group and 14.2 in the endometrial ablation group (difference 50.5 points, 95% CI 4.3 to 96.7, non-inferiority P=0.87 (25 PBAC-points margin)).","['women with heavy menstrual bleeding', 'heavy menstrual bleeding', 'Women with heavy menstrual bleeding, aged 34 and older, without a pregnancy wish or intracavitary pathology', '132 women were allocated to the levonorgestrel intrauterine system (baseline PBAC-score 616) and 138 women to endometrial ablation (baseline PBAC-score 630', '645 women as eligible of whom 270 women provided informed consent', '26 hospitals and in a network of general practices in the Netherlands', 'Women who start with the levonorgestrel intrauterine system, a reversible and less invasive treatment']","['levonorgestrel intrauterine system', 'levonorgestrel intrauterine system (Mirena) or to endometrial ablation, performed with the bipolar radiofrequency device (NovaSure', 'levonorgestrel intrauterine system and endometrial ablation', 'Levonorgestrel releasing intrauterine system versus endometrial ablation']","['risk of needing additional treatment', 'mean PBAC-scores', 'menstrual blood loss', 'blood loss at 24 months, measured with a Pictorial Blood Assessment Chart (PBAC)-score', 're-intervention rates, patient satisfaction, quality of life, and sexual function', 'patient satisfaction and quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1298613', 'cui_str': 'Intracavitary'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C4708165', 'cui_str': '630'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4293465', 'cui_str': 'Levonorgestrel Intrauterine System [Kyleena]'}, {'cui': 'C0341803', 'cui_str': 'Endometrial ablation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0023566', 'cui_str': 'Levonorgestrel'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4293370', 'cui_str': 'Intrauterine System'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]",645.0,0.184613,"At 24 months, mean PBAC-scores were 64.8 in the levonorgestrel intrauterine system group and 14.2 in the endometrial ablation group (difference 50.5 points, 95% CI 4.3 to 96.7, non-inferiority P=0.87 (25 PBAC-points margin)).","[{'ForeName': 'Pleun', 'Initials': 'P', 'LastName': 'Beelen', 'Affiliation': 'Department of Obstetrics and Gynecology, Máxima MC, Veldhoven, the Netherlands; Department of General Practice, University of Maastricht, Maastricht, the Netherlands. Electronic address: pleun.beelen@gmail.com.'}, {'ForeName': 'Marian J', 'Initials': 'MJ', 'LastName': 'VAN DEN Brink', 'Affiliation': 'Department of General Practice & Elderly care medicine, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Malou C', 'Initials': 'MC', 'LastName': 'Herman', 'Affiliation': ""Department of Obstetrics and Gynecology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Peggy M', 'Initials': 'PM', 'LastName': 'Geomini', 'Affiliation': 'Department of Obstetrics and Gynecology, Máxima MC, Veldhoven, the Netherlands.'}, {'ForeName': 'Janny H', 'Initials': 'JH', 'LastName': 'Dekker', 'Affiliation': 'Department of General Practice & Elderly care medicine, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Ruben G', 'Initials': 'RG', 'LastName': 'Duijnhoven', 'Affiliation': 'Department of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'M A K', 'Initials': 'MAK', 'LastName': 'Nienke', 'Affiliation': 'Department of General Practice, University of Maastricht, Maastricht, the Netherlands.'}, {'ForeName': 'Hannah S', 'Initials': 'HS', 'LastName': 'VAN Meurs', 'Affiliation': 'Department of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Sjors F', 'Initials': 'SF', 'LastName': 'Coppus', 'Affiliation': 'Department of Obstetrics and Gynecology, Máxima MC, Veldhoven, the Netherlands.'}, {'ForeName': 'Jan Willem', 'Initials': 'JW', 'LastName': 'VAN DER Steeg', 'Affiliation': ""Department of Obstetrics and Gynecology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Heleen P', 'Initials': 'HP', 'LastName': 'Eising', 'Affiliation': 'Department of Obstetrics and Gynecology, Gelre Hospital, Apeldoorn, the Netherlands.'}, {'ForeName': 'Diana S', 'Initials': 'DS', 'LastName': 'Massop-Helmink', 'Affiliation': 'Department of Obstetrics and Gynecology, Medisch Spectrum Twente, Twente, the Netherlands.'}, {'ForeName': 'Ellen R', 'Initials': 'ER', 'LastName': 'Klinkert', 'Affiliation': 'Department of Obstetrics and Gynecology, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Theodoor E', 'Initials': 'TE', 'LastName': 'Nieboer', 'Affiliation': 'Department of Obstetrics and Gynecology, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Timmermans', 'Affiliation': 'Department of Obstetrics and Gynecology, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Lucet F', 'Initials': 'LF', 'LastName': 'VAN DER Voet', 'Affiliation': 'Department of Obstetrics and Gynecology, Deventer Hospital, Deventer, the Netherlands.'}, {'ForeName': 'Sebastiaan', 'Initials': 'S', 'LastName': 'Veersema', 'Affiliation': 'Department of Reproductive Medicine and Gynecology, UMC Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Nicol A C', 'Initials': 'NAC', 'LastName': 'Smeets', 'Affiliation': 'Department of Obstetrics and Gynecology, Zuyderland Medical Centre, Heerlen, the Netherlands.'}, {'ForeName': 'Joke M', 'Initials': 'JM', 'LastName': 'Schutte', 'Affiliation': 'Department of Obstetrics and Gynecology, Isala Hospital, Zwolle, the Netherlands.'}, {'ForeName': 'Marchien', 'Initials': 'M', 'LastName': 'VAN Baal', 'Affiliation': 'Department of Obstetrics and Gynecology, Flevo Hospital, Almere, the Netherlands.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Bossuyt', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, Amsterdam, the Netherlands.'}, {'ForeName': 'Ben Willem J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynecology, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Marjolein Y', 'Initials': 'MY', 'LastName': 'Berger', 'Affiliation': 'Department of General Practice & Elderly care medicine, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Marlies Y', 'Initials': 'MY', 'LastName': 'Bongers', 'Affiliation': 'Department of Obstetrics and Gynecology, Máxima MC, Veldhoven, the Netherlands; Research School Grow, University of Maastricht, Maastricht, the Netherlands.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.08.016']
2131,32795561,Comparative effect of Liuzijue Qigong and conventional respiratory training on trunk control ability and respiratory muscle function in patients at an early recovery stage from stroke: a randomized controlled trial.,"OBJECTIVE


To compare the effects of Liuzijue Qigong and conventional respiratory training on trunk control ability and respiratory muscle functions in patients at an early recovery stage from stroke.
DESIGN


A single-blind, randomized controlled trial.
SETTING


A hospital PARTICIPANTS: 60 patients within 2 months post-stroke.
INTERVENTIONS


The experimental group (N=30) received conventional rehabilitation training combined with Liuzijue exercise, the control group (N=30) received conventional rehabilitation training combined with conventional respiration training. The training in the 2 groups was conducted 5 times per week for 3 weeks.
MAIN MEASURES


Trunk Impairment Scale (TIS), Maximum Inspiratory Pressure (MIP), Maximum Expiratory Pressure (MEP), Forced Expiratory Volume in the first second (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF), Maximum Expiratory Mid-flow (MMEF), diaphragmatic movement, the change of intra-abdominal pressure (IAP), Berg Balance Scale (BBS) and Modified Barthel Index (MBI). All outcome measures were assessed twice (at baseline and 3 weeks).
RESULTS


Both groups significantly improved in TIS, MIP, FVC, PEF, the change of IAP, BBS and MBI when pre- and post-assessments (P<0.05) were compared. In contrast to the control group, there was a significant difference in the experimental group in the static sitting balance subscale (P=0.014), dynamic balance subscale (P=0.001), coordination subscale (P<0.001), TIS total scores (P<0.001, ES=0.9), MIP (P=0.012, 95% CI 2.23 to 17.69, ES=0.67), MEP (P=0.015, 95% CI 1.85 to 16.57, ES=0.65), the change of IAP (P=0.001), and MBI (P=0.016, 95% CI 1.51 to 14.16, ES=0.64). No significant differences were found between the 2 groups in FEV1 (P=0.24), FVC (P =0.43), PEF (P=0.202), MMEF (P=0.277), the diaphragmatic movement of quiet breathing (P=0.146) and deep breathing (P=0.102), and BBS (P=0.124).
CONCLUSION


The Liuzijue showed more changes than conventional respiratory training in improving trunk control ability, respiratory muscle functions and ADL ability in patients at an early recovery stage from stroke.",2020,"Both groups significantly improved in TIS, MIP, FVC, PEF, the change of IAP, BBS and MBI when pre- and post-assessments (P<0.05) were compared.","[' 60 patients within 2 months post-stroke', 'patients at an early recovery stage from stroke']","['Liuzijue Qigong and conventional respiratory training', 'conventional rehabilitation training combined with Liuzijue exercise, the control group', 'conventional rehabilitation training combined with conventional respiration training', 'conventional respiratory training']","['Trunk Impairment Scale (TIS), Maximum Inspiratory Pressure (MIP), Maximum Expiratory Pressure (MEP), Forced Expiratory Volume in the first second (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF), Maximum Expiratory Mid-flow (MMEF), diaphragmatic movement, the change of intra-abdominal pressure (IAP), Berg Balance Scale (BBS) and Modified Barthel Index (MBI', 'TIS, MIP, FVC, PEF, the change of IAP, BBS and MBI', 'static sitting balance subscale', 'change of IAP', 'dynamic balance subscale', 'PEF', 'diaphragmatic movement of quiet breathing', 'deep breathing', 'trunk control ability and respiratory muscle function', 'MIP', 'BBS', 'MEP', 'trunk control ability, respiratory muscle functions and ADL ability', 'trunk control ability and respiratory muscle functions', 'TIS total scores', 'FEV1', 'coordination subscale', 'MBI', 'FVC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0282077', 'cui_str': 'Qigong'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0232021', 'cui_str': 'Peak inspiratory pressure'}, {'cui': 'C0232022', 'cui_str': 'Peak expiratory pressure'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0232079', 'cui_str': 'Diaphragmatic movement'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C1321587', 'cui_str': 'Excessively deep breathing'}, {'cui': 'C0426971', 'cui_str': 'Trunk control'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}]",,0.0701272,"Both groups significantly improved in TIS, MIP, FVC, PEF, the change of IAP, BBS and MBI when pre- and post-assessments (P<0.05) were compared.","[{'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China; School of Kinesiology, Shanghai University of Sport, Shanghai, China. Electronic address: ZhangYing032317@163.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China. Electronic address: ZhangYing032317@163.com.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Shanghai Shenyuan Rehabilitation Hospital, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Qiao', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Fu', 'Affiliation': 'School of Kinesiology, Shanghai University of Sport, Shanghai, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Gaiyan', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Ni', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Yong', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Yanmin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Fan', 'Affiliation': 'Department of Rehabilitation, Shanghai Xuhui Central Hospital, Shanghai, China.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.07.007']
2132,32795562,"Effects of dual-task group training on gait, cognitive executive function and quality of life in people with Parkinson's disease: results of randomized controlled DUALGAIT trial.","OBJECTIVES


This study aims (1) to analyze the effects of a dual-task group program, (2) to compare it with the effects of a single-task group program and, (3) to analyze the effects of functional secondary tasks.
DESIGN


Single-blind randomized controlled trial.
SETTING


University laboratory, rehabilitation gym at health center.
PARTICIPANTS


People (N = 40) with a diagnosis of Parkinson's disease (aged 66.72 [44-79] years, Hoehn and Yahr stage I-II-III and on-medication) were randomized to (1) a group with dual-task training or (2) a group with single-task training (only gait).
INTERVENTION


Both interventions involved 20 one-hour sessions conducted twice a week. Dual-task training included walking exercises and cognitive or motor tasks carried out separately, later performed together as a dual-task according to a progressive protocol in the same training session.
MAIN OUTCOME MEASURES


Velocity and spatiotemporal parameters of gait were measured without a secondary task and during dual-task gait combined with a visual, verbal, auditory and motor task. In addition, Executive cognitive function and Quality of life were measured. Assessment were conducted at baseline, post-rehabilitation, and at 8-weeks follow-up.
RESULTS


Dual-task group improved Velocity, and Stride length time in all assessment conditions after training (p < .05), like their perceived Quality of life (p < .05). Single-task group experienced improvements in the same outcomes only for the motor condition (p < .05) after training, but failed to improve perceived Quality of life (p > .05). Likewise, the dual-task group showed higher Velocity and Stride length after treatment than the single-task group across conditions. No significant changes in cognitive performance were observed (p > .05), although DT group tended to improve performance during the executive function test.
CONCLUSIONS


Dual tasks training in functional contexts is associated with greater improvements in velocity and stride length in patients with PD as compared to regular physiotherapy without secondary tasks, and improves perceived Quality of life.",2020,"Single-task group experienced improvements in the same outcomes only for the motor condition (p < .05) after training, but failed to improve perceived Quality of life (p > .05).","[""People (N = 40) with a diagnosis of Parkinson's disease (aged 66.72"", 'University laboratory, rehabilitation gym at health center', 'patients with PD', '44-79] years, Hoehn and Yahr stage I-II-III and on-medication', ""people with Parkinson's disease""]","['Dual-task training included walking exercises and cognitive or motor tasks carried out separately, later performed together as a dual-task according to a progressive protocol', 'dual-task group training', 'Dual tasks training', 'dual-task training or (2) a group with single-task training (only gait']","['cognitive performance', 'gait, cognitive executive function and quality of life', 'like their perceived Quality of life', 'Velocity, and Stride length time', 'Executive cognitive function and Quality of life', 'motor condition', 'velocity and stride length', 'Velocity and Stride length', 'Velocity and spatiotemporal parameters of gait were measured without a secondary task and during dual-task gait combined with a visual, verbal, auditory and motor task', 'perceived Quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589089', 'cui_str': 'Executive cognitive functions'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}]",40.0,0.0321115,"Single-task group experienced improvements in the same outcomes only for the motor condition (p < .05) after training, but failed to improve perceived Quality of life (p > .05).","[{'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'San Martín Valenzuela', 'Affiliation': 'Unit of Personal Autonomy, Dependency and Mental Disorder Assessment, Faculty of Medicine, University of Valencia, Blasco Ibáñez, 15, 46010 Valencia, Spain; Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, 46010 Valencia, Spain; UBIC Reseach Group, Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, 46010 Valencia, Spain; Centro Investigación Biomédica en Red de Salud Mental, CIBERSAM, Av. Monforte de Lemos, 3-5, 28029 Madrid Madrid, Spain.'}, {'ForeName': 'Lirios Dueñas', 'Initials': 'LD', 'LastName': 'Moscardó', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, 46010 Valencia, Spain.'}, {'ForeName': 'Juan López', 'Initials': 'JL', 'LastName': 'Pascual', 'Affiliation': 'Biomechanics Institute of Valencia, Polytechnic University of Valencia, Camino de Vera, s/n, 46022 Valencia, Spain.'}, {'ForeName': 'Pilar Serra', 'Initials': 'PS', 'LastName': 'Añó', 'Affiliation': 'Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, 46010 Valencia, Spain; UBIC Reseach Group, Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia, Gascó Oliag Street, 5, 46010 Valencia, Spain. Electronic address: pilar.serra@uv.es.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Tomás', 'Affiliation': 'Department of Behavioral Sciences Methodology, Faculty of Psychology, University of Valencia, Blasco Ibánez Avenue, 13, 46010 Valencia, Spain.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.07.008']
2133,32799216,Performance of Double-Arm Digital Subtraction Angiography (DSA)-Guided and C-Arm-Guided Percutaneous Kyphoplasty (PKP) to Treat Senile Osteoporotic Vertebral Compression Fractures.,"BACKGROUND Osteoporotic vertebral compression fracture (OVCF) is a common fracture in the elderly. Conservative treatment requires prolonged bedding, which may lead to serious complications. To explore optimized use of percutaneous kyphoplasty (PKP) in the treatment of senile osteoporotic thoracolumbar vertebral compression fractures, in this study, we used C-arm-guided and double-arm digital subtraction angiography (DSA)-guided PKP to treat OVCF in elderly patients and analyzed the effective recovery. MATERIAL AND METHODS In all, 60 patients who presented with osteoporotic vertebral compression fractures at our hospital between July 2017 and February 2019 were analyzed. They were randomly divided into C-arm-guided group and the double-arm DSA-guided groups. Both groups were treated with percutaneous kyphoplasty. RESULTS A pain VAS score analysis revealed that there was no significant difference between the two groups before surgery (P>0.05). After surgery, the VAS scores showed a significant difference between the C-arm-guided group and the double-arm DSA-guided PKP treatment group (P<0.01). Moreover, with respect to the bone cement dosage, vertebral correction height, operation time, cumulative radiation dose, percolation rate, and volume of bone cement, the double-arm DSA-guided PKP treatment showed significantly better results than the C-arm-guided PKP treatment (P<0.01). CONCLUSIONS Our data revealed that double-arm DSA-guided PKP was more accurate in treatment of senile osteoporotic thoracolumbar vertebral compression fractures, producing excellent performance with more accurate intraoperative evaluation, shorter operative time, lower incidence of bone cement leakage, less intraoperative radiation dose, and higher safety, and thus, could be extensively applied to clinical surgery.",2020,"After surgery, the VAS scores showed a significant difference between the C-arm-guided group and the double-arm DSA-guided PKP treatment group (P<0.01).","['Senile Osteoporotic Vertebral Compression Fractures', '60 patients who presented with osteoporotic vertebral compression fractures at our hospital between July 2017 and February 2019 were analyzed', 'senile osteoporotic thoracolumbar vertebral compression fractures', 'elderly patients']","['Osteoporotic vertebral compression fracture (OVCF', 'percutaneous kyphoplasty (PKP', 'C-arm-guided and double-arm digital subtraction angiography (DSA)-guided PKP', 'percutaneous kyphoplasty', 'Double-Arm Digital Subtraction Angiography (DSA)-Guided and C-Arm-Guided Percutaneous Kyphoplasty (PKP']","['operative time, lower incidence of bone cement leakage', 'VAS scores', 'bone cement dosage, vertebral correction height, operation time, cumulative radiation dose, percolation rate, and volume of bone cement', 'pain VAS score analysis']","[{'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0002979', 'cui_str': 'Digital subtraction angiography'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005934', 'cui_str': 'Bone cements'}, {'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",60.0,0.0238899,"After surgery, the VAS scores showed a significant difference between the C-arm-guided group and the double-arm DSA-guided PKP treatment group (P<0.01).","[{'ForeName': 'Jihe', 'Initials': 'J', 'LastName': 'Ban', 'Affiliation': 'Department of Orthopedics, Zhejiang Rongjun Hospital, Jiaxing, Zhejiang, China (mainland).'}, {'ForeName': 'Lilu', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Department of Orthopedics, Zhejiang Rongjun Hospital, Jiaxing, Zhejiang, China (mainland).'}, {'ForeName': 'Pengpeng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Zhejiang Rongjun Hospital, Jiaxing, Zhejiang, China (mainland).'}, {'ForeName': 'Yunhai', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedics, Zhejiang Rongjun Hospital, Jiaxing, Zhejiang, China (mainland).'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Department of Invasive Technology, Zhejiang Rongjun Hospital, Jiaxing, Zhejiang, China (mainland).'}, {'ForeName': 'Guangtao', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Forensic and Pathology Laboratory, Judicial Expertise Center, Jiaxing University Medical College, Jiaxing, Zhejiang, China (mainland).'}, {'ForeName': 'Xingen', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedics, Zhejiang Rongjun Hospital, Jiaxing, Zhejiang, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.923619']
2134,32799244,Eye-glasses wear compliance following school-based visual acuity screening in Nepal: a comparative study.,"INTRODUCTION


Eye-glasses wear compliance is found to be low among children in school-based eye screening programs who are provided spectacles free of charge.
METHODS


Thirty-six schools from school visual acuity screening program in Nepal were randomly selected to receive no follow-up (standard) or follow-up by an optometry team at 3 months. In the intervention group (that received the follow-up), ophthalmic personal made unannounced visits to the schools at 3 months to determine spectacle compliance .Direct examination to determine compliance with spectacle wear 6 months was done. The primary reason for noncompliance from a list of possibilities was identified using a questionnaire.
RESULTS


Among 297 (145 control and 152 intervention) students that received glasses in the 36 schools, 128/152 (84%) were available for examination at 3 months in the intervention group. A total of 216/297 (73%) students were available for examination at 6 months (73 % and 72% of the control and intervention groups, respectively). Within the intervention group, 51% of children at 3 months and 57% at 6 months were wearing glasses during the unannounced visits. The main source of refractive error was myopia. Out of 66 children with astigmatism, 24 (36%) were wearing glasses. There was no statistically significant difference in compliance (p=0.85) between private and public schools, but compliance correlated better with the educational status of careers.
CONCLUSION


A follow-up visit to the school by eye care personnel did not improve spectacle wear compliance among children .Other factors may also be responsible for poor compliance.",2020,"There was no statistically significant difference in compliance (p=0.85) between private and public schools, but compliance correlated better with the educational status of careers.
","['in Nepal', 'Thirty-six schools from school visual acuity screening program in Nepal', '297 (145 control and 152 intervention) students that received glasses in the 36 schools, 128/152 (84', 'children .Other', '66 children with astigmatism, 24 (36%) were wearing glasses']","['ophthalmic personal made unannounced visits to the schools at 3 months to determine spectacle compliance .Direct', 'Eye-glasses wear compliance following school-based visual acuity screening']",['educational status of careers'],"[{'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004106', 'cui_str': 'Astigmatism'}, {'cui': 'C0558172', 'cui_str': 'Wears glasses'}]","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0013658', 'cui_str': 'Educational achievement'}]",66.0,0.0553247,"There was no statistically significant difference in compliance (p=0.85) between private and public schools, but compliance correlated better with the educational status of careers.
","[{'ForeName': 'Hari Bahadur', 'Initials': 'HB', 'LastName': 'Thapa', 'Affiliation': 'Lumbini Eye Institute, Siddharthanagar, Bhairahawa, Nepal.'}, {'ForeName': 'Salma Kc', 'Initials': 'SK', 'LastName': 'Rai', 'Affiliation': ''}, {'ForeName': 'Saraswati Khadka', 'Initials': 'SK', 'LastName': 'Thapa', 'Affiliation': ''}, {'ForeName': 'Anadi', 'Initials': 'A', 'LastName': 'Khatri', 'Affiliation': ''}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Bassett', 'Affiliation': ''}]",Nepalese journal of ophthalmology : a biannual peer-reviewed academic journal of the Nepal Ophthalmic Society : NEPJOPH,['10.3126/nepjoph.v12i1.25736']
2135,32799275,Effect of deep breathing exercises in healthy smokers: A pilot study.,"OBJECTIVE


To determine the effect of deep breathing exercises on lung functions in apparently healthy smokers.
METHODS


The pilot study was conducted at Isra University, Islamabad, Pakistan, from May to December, 2017, and comprised apparently healthy smokers aged 20-30 years with a minimum smoking history of 5 years. The participants were divided into control and experimental groups. The control group was not given any treatment, while the experimental group was trained on deep breathing exercise techniques. Baseline data was compared after two weeks of intervention. SPSS 21 was used for data analysis.
RESULTS


Of the 30 subjects, there were 15(50%) in each of the two groups. In the experimental group, significant changes were found in vital capacity, inspiratory capacity, tidal volume, expiratory reserve volume, force expiratory volume, and forced vital capacity (p<0.05). Post-intervention, all parameters improved significantly in the experimental group (p<0.05).
CONCLUSIONS


Deep breathing exercise techniques were found to be useful in healthy smokers for improving lung functions and delaying the development of chronic obstructive lung complications.",2020,"In the experimental group, significant changes were found in vital capacity, inspiratory capacity, tidal volume, expiratory reserve volume, force expiratory volume, and forced vital capacity (p<0.05).","['Isra University, Islamabad, Pakistan, from May to December, 2017, and comprised apparently healthy smokers aged 20-30 years with a minimum smoking history of 5 years', '30 subjects', 'healthy smokers', 'apparently healthy smokers']","['deep breathing exercises', 'deep breathing exercise techniques', 'Deep breathing exercise techniques']","['vital capacity, inspiratory capacity, tidal volume, expiratory reserve volume, force expiratory volume, and forced vital capacity (p<0.05', 'lung functions']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0454496', 'cui_str': 'Deep breathing exercises'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0015326', 'cui_str': 'Expiratory reserve volume'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.0139538,"In the experimental group, significant changes were found in vital capacity, inspiratory capacity, tidal volume, expiratory reserve volume, force expiratory volume, and forced vital capacity (p<0.05).","[{'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Abid', 'Affiliation': 'Department of Physical Therapy, Isra Institute of Rehabilitation Science, Isra University, Islamabad, Pakistan.'}, {'ForeName': 'Anees Rafiq', 'Initials': 'AR', 'LastName': 'Rao', 'Affiliation': 'Department of Physical Therapy, National Institute of Rehabilitation Medicine (NIMR), Islamabad, Pakistan.'}, {'ForeName': 'Muhammad Naveed', 'Initials': 'MN', 'LastName': 'Babar', 'Affiliation': 'Isra Institute of Rehabilitation Sciences, Isra University, Islamabad.'}, {'ForeName': 'Misha', 'Initials': 'M', 'LastName': 'Ansari', 'Affiliation': 'Department of Physical Therapy, Isra Institute of Rehabilitation Science, Isra University, Islamabad, Pakistan.'}, {'ForeName': 'Waqar Ahmed', 'Initials': 'WA', 'LastName': 'Awan', 'Affiliation': 'Isra Institute of Rehabilitation Sciences, Isra University, Islamabad,Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.16551']
2136,32799362,"A Randomized, Triple-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy of a Freshwater Marine Collagen on Skin Wrinkles and Elasticity.","BACKGROUND


Collagen is the primary component in human skin. With age, there is loss of skin elasticity and collagen, resulting in wrinkle formation and reduction in skin appearance. The objective of this randomized, triple-blind, placebo-controlled study was to evaluate the safety and efficacy of a hydrolyzed marine collagen (Vinh Wellness Collagen, VWC) on aspects of skin health and quality in women between 45-60 years of age.
METHODS


Assessments of skin wrinkles, elasticity and self-reported appearance were conducted using the VISIA skin analysis system, Cutometer ®  and Skin Quality Visual Analogue Scale. Outcomes were assessed at weeks 0 (baseline), 6 and 12.
RESULTS


After 12 weeks, participants supplemented with VWC had a significant 35% reduction in wrinkle score (p = 0.035) from baseline. Participants in the VWC group showed a 24% greater reduction in wrinkles on the right side of the face than those on placebo. A planned subgroup analysis based on age showed women 45-54 y had a significant 20% and 10% improvement in cheek skin elasticity from baseline to week 6 (p = 0.016) and 12 (p = 0.022), respectively. At week 12, participants in the VWC group reported greater percentage improvements in overall skin score (9%) and wrinkle (15%), elasticity (23%), hydration (14%), radiance (22%) and firmness (25%) scores vs. placebo.
CONCLUSION


Supplementation with VWC was found to be safe and well-tolerated. The results of this study support the use of fish-derived hydrolyzed collagen for the improvement of skin health in an aging population.",2020,Participants in the VWC group showed a 24% greater reduction in wrinkles on the right side of the face than those on placebo.,"['human skin', 'women between 45-60 years of age']","['Freshwater Marine Collagen', 'Placebo', 'fish-derived hydrolyzed collagen', 'hydrolyzed marine collagen (Vinh Wellness Collagen, VWC', 'VWC', 'placebo']","['wrinkle score', 'skin health', 'overall skin score', 'Skin Wrinkles and Elasticity', 'VISIA skin analysis system, Cutometer ®  and Skin Quality Visual Analogue Scale', 'safety and efficacy', 'safe and well-tolerated', 'skin health and quality', 'elasticity', 'cheek skin elasticity']","[{'cui': 'C3859811', 'cui_str': 'human skin preparation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0016710', 'cui_str': 'Fresh water'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039152', 'cui_str': 'Analysis, Systems'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0222085', 'cui_str': 'Skin structure of cheek'}]",,0.117762,Participants in the VWC group showed a 24% greater reduction in wrinkles on the right side of the face than those on placebo.,"[{'ForeName': 'Malkanthi', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'KGK Science Inc, 255 Queens Ave, London, Ontario, N6A 5R8, Canada.'}, {'ForeName': 'Erin D', 'Initials': 'ED', 'LastName': 'Lewis', 'Affiliation': 'KGK Science Inc, 255 Queens Ave, London, Ontario, N6A 5R8, Canada.'}, {'ForeName': 'Nisrine', 'Initials': 'N', 'LastName': 'Zakaria', 'Affiliation': 'KGK Science Inc, 255 Queens Ave, London, Ontario, N6A 5R8, Canada.'}, {'ForeName': 'Tetyana', 'Initials': 'T', 'LastName': 'Pelipyagina', 'Affiliation': 'KGK Science Inc, 255 Queens Ave, London, Ontario, N6A 5R8, Canada.'}, {'ForeName': 'Najla', 'Initials': 'N', 'LastName': 'Guthrie', 'Affiliation': 'KGK Science Inc, 255 Queens Ave, London, Ontario, N6A 5R8, Canada.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13676']
2137,32799667,Comparing prospective headache diary and retrospective four-week headache questionnaire over 20 weeks: Secondary data analysis from a randomized controlled trial.,"BACKGROUND


Headache diaries and recall questionnaires are frequently used to assess headache frequency and severity in clinical and research settings.
METHODS


Using 20 weeks of data from an intervention trial with 182 participants, we evaluated concordance between an electronic headache diary administered on a daily basis and designed to capture the presence and severity of headaches on an hourly basis (the headache diary) and a recall questionnaire, with retrospective estimation of the number of headache days assessed on a monthly basis. We further examined whether the duration or severity of headaches assessed by the electronic diary impacted concordance between these two measures.
RESULTS


Over the course of four 28-day periods, people with migraine participating in a dietary intervention reported an average of 13.7 and 11.1 headache days in the headache diary and recall questionnaire, respectively.
CONCLUSION


Over time, the concordance between headache days reported in these two measures tended to increase; however, the recall questionnaire headache estimates were lower than the diary measures in all four periods. When analysis was restricted to headaches lasting 8 hours or more, the number of headache days was more closely aligned with days reported in the recall questionnaire, indicating that the accuracy of recall estimates is likely to be influenced by headache duration. Restriction of analyses to moderate-to-severe headaches did not change results as much as headache duration. The findings indicate that recall questionnaires administered on a monthly basis may underestimate headache frequency and therefore should not be used interchangeably with headache diaries. Clinical Trials.gov Identifier : NCT02012790.",2020,"Over time, the concordance between headache days reported in these two measures tended to increase; however, the recall questionnaire headache estimates were lower than the diary measures in all four periods.","['people with migraine participating in a', '182 participants']",['dietary intervention'],"['headache frequency', 'duration or severity of headaches', 'recall questionnaire headache estimates', 'headache duration', 'headache diary and recall questionnaire, respectively']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}]","[{'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}]",182.0,0.0376969,"Over time, the concordance between headache days reported in these two measures tended to increase; however, the recall questionnaire headache estimates were lower than the diary measures in all four periods.","[{'ForeName': 'Vanessa E', 'Initials': 'VE', 'LastName': 'Miller', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Keturah R', 'Initials': 'KR', 'LastName': 'Faurot', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Olafur S', 'Initials': 'OS', 'LastName': 'Palssson', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'MacIntosh', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Chirayath', 'Initials': 'C', 'LastName': 'Suchindran', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Gilson', 'Initials': 'G', 'LastName': 'Honvoh', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Gaylord', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Ramsden', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'J Douglas', 'Initials': 'JD', 'LastName': 'Mann', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Program on Integrative Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420949180']
2138,32799709,"Anti-Inflammatory HDL Function, Incident Cardiovascular Events, and Mortality: A Secondary Analysis of the JUPITER Randomized Clinical Trial.","Background High-density lipoprotein (HDL) cholesterol has inverse association with cardiovascular disease. HDL possesses anti-inflammatory properties in vitro, but it is unknown whether this may be protective in individuals with inflammation. Methods and Results The functional capacity of HDL to inhibit oxidation of oxidized low-density lipoprotein (ie, the HDL inflammatory index; HII) was measured at baseline and 12 months after random allocation to rosuvastatin or placebo in a nested case-control study of the JUPITER (Justification for the Use of Statins in Prevention: An Intervention Evaluating Rosuvastatin) trial. There were 517 incident cases of cardiovascular disease and all-cause mortality compared to 517 age- and sex-matched controls. Multivariable conditional logistic regression was used to examine associations of HII with events. Median baseline HII was 0.54 (interquartile range, 0.50-0.59). Twelve months of rosuvastatin decreased HII by a mean of 5.3% (95% CI, -8.9% to -1.7%;  P =0.005) versus 1.3% (95% CI, -6.5% to 4.0%;  P =0.63) with placebo ( P =0.22 for between-group difference). HII had a nonlinear relationship with incident events. Compared with the reference group (HII 0.5-1.0) with the lowest event rates, participants with baseline HII ≤0.5 had significantly increased risk of cardiovascular disease/mortality (adjusted hazard ratio, 1.53; 95% CI, 1.06-2.21;  P =0.02). Furthermore, there was significant ( P =0.002) interaction for HDL particle number with HII, such that having more HDL particles was associated with decreased risk only when HDL was anti-inflammatory. Conclusions In JUPITER participants recruited on the basis of chronic inflammation, HII was associated with incident cardiovascular disease/mortality, with an optimal anti-inflammatory HII range between 0.5 and 1.0. This nonlinear relationship of anti-inflammatory HDL function with risk may account in part for the HDL paradox. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT00239681.",2020,"Twelve months of rosuvastatin decreased HII by a mean of 5.3% (95% CI, -8.9% to -1.7%;  P =0.005) versus 1.3% (95% CI, -6.5% to 4.0%;  P =0.63) with placebo ( P =0.22 for between-group difference).","['individuals with inflammation', 'In JUPITER participants recruited on the basis of chronic inflammation, HII was associated with incident cardiovascular disease/mortality, with an optimal anti-inflammatory HII range between 0.5 and 1.0']","['rosuvastatin', 'rosuvastatin or placebo', 'Registration URL', ' High-density lipoprotein (HDL) cholesterol', 'placebo']","['risk of cardiovascular disease/mortality', 'Median baseline HII', 'Anti-Inflammatory HDL Function, Incident Cardiovascular Events, and Mortality', 'cardiovascular disease and all-cause mortality']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242754', 'cui_str': 'Jupiter'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammation'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3541384', 'cui_str': 'URL'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",517.0,0.234502,"Twelve months of rosuvastatin decreased HII by a mean of 5.3% (95% CI, -8.9% to -1.7%;  P =0.005) versus 1.3% (95% CI, -6.5% to 4.0%;  P =0.63) with placebo ( P =0.22 for between-group difference).","[{'ForeName': 'Oluremi N', 'Initials': 'ON', 'LastName': 'Ajala', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Olga V', 'Initials': 'OV', 'LastName': 'Demler', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Zareen', 'Initials': 'Z', 'LastName': 'Farukhi', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Adelman', 'Affiliation': 'VascularStrategies Plymouth PA.'}, {'ForeName': 'Heidi L', 'Initials': 'HL', 'LastName': 'Collins', 'Affiliation': 'VascularStrategies Plymouth PA.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Rader', 'Affiliation': 'Department of Genetics University of Pennsylvania Philadelphia PA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}, {'ForeName': 'Samia', 'Initials': 'S', 'LastName': 'Mora', 'Affiliation': ""Center for Lipid Metabolomics and Division of Preventive Medicine Brigham and Women's Hospital Boston MA.""}]",Journal of the American Heart Association,['10.1161/JAHA.119.016507']
2139,32799723,"Effects of acupressure, gum chewing and coffee consumption on the gastrointestinal system after caesarean section under spinal anaesthesia.","This study evaluated the efficacy and safety of postoperative acupressure in the recovery of the gastrointestinal system (GIS) after caesarean section. A total of 160 primipara pregnant women delivered by caesarean section under spinal anaesthesia were randomised into four groups: group 1 (those who received acupressure), group 2 (coffee was provided three times a day), group 3 (chewed sugar-free gum for 15 min with an interval of 4 h from the second postoperative hour), and group 4 (control group). The first gas outflow and defaecation times of the women were compared among the groups. The first flatus and defaecation exit times of the women in the acupressure group were statistically earlier than those of the other groups. No difference was found among the gum-chewing, coffee, and control groups. Acupressure is effective in reducing the flatus and defaecation exit times due to GIS inactivity after abdominal surgery including caesarean section. Impact statement  What is already known about the topic.  The slowing of gastrointestinal system (GIS) motility also occurs after caesarean section aside from other surgical operations. If normal GIS movements do not occur, then several problems, such as the negative increase in the duration of breastfeeding and the mother-baby attachment during the postpartum period, may arise. Therefore, the early onset of bowel functions is important in women who give birth by caesarean section.  What do the results of this study add.  In the postoperative period, spontaneous GIS motility can be achieved by applying acupressure. The effective use of acupressure in the postoperative period prevents the need for pharmacological methods to eliminate the discomfort caused by the decreased motility of the GIS in women in the postpartum period.  What are the implications of these findings for clinical practice and further research.  Acupressure, a non-invasive, easy-to-use, and cost-effective method, plays a role in preventing GIS immotility. Midwives or obstetricians should receive training on acupuncture or acupressure and should ensure that acupuncture or acupressure practices are converted into a protocol to be implemented in the postoperative period. With this transformation, the treatment methods to increase GIS motility and the reduced medication use can decrease the mother's and the newborn's duration of hospital stay and the cost of hospitalisation.",2020,The first flatus and defaecation exit times of the women in the acupressure group were statistically earlier than those of the other groups.,"['160 primipara pregnant women delivered by caesarean section under spinal anaesthesia', 'women who give birth by caesarean section', 'gastrointestinal system after caesarean section under spinal anaesthesia', 'caesarean section']","['postoperative acupressure', 'acupressure, gum chewing and coffee consumption', 'acupuncture or acupressure', 'acupressure', 'Acupressure', 'acupuncture or acupressure practices']","['slowing of gastrointestinal system (GIS) motility', ""newborn's duration of hospital stay and the cost of hospitalisation"", 'first flatus and defaecation exit times', 'efficacy and safety', 'GIS motility', 'spontaneous GIS motility']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0012240', 'cui_str': 'Structure of digestive system'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0012240', 'cui_str': 'Structure of digestive system'}, {'cui': 'C0007608', 'cui_str': 'Motility, Cell'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0337094', 'cui_str': 'Exit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]",160.0,0.0130441,The first flatus and defaecation exit times of the women in the acupressure group were statistically earlier than those of the other groups.,"[{'ForeName': 'Derya', 'Initials': 'D', 'LastName': 'Kanza Gül', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of Istanbul Medipol, Istanbul, Turkey.'}, {'ForeName': 'Ayça', 'Initials': 'A', 'LastName': 'Şolt Kırca', 'Affiliation': 'Department of Midwifery, Kırklareli University School of Health, Kırklareli, Turkey.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2020.1787363']
2140,32799729,Optimised force-velocity training during pre-season enhances physical performance in professional rugby league players.,"The effectiveness of 8-week force-velocity optimised training was assessed in highly trained professional rugby league athletes. Players (age 24 ± 3 years; body mass 94.9 ± 21.6 kg; height 181.3 ± 6.0 cm) were strength-matched and assigned to a force-velocity optimised group (OP;  n  = 15) or a general strength-power group (GP;  n  = 14). Tests included 10-m, 20-m sprints, 3 repetition-maximum squat and squat jumps over five load conditions to ascertain vertical force-velocity relationship. ANCOVA revealed there was a group effect for force-velocity deficit ( P  < 0.001), with the OP two-fold greater than the GP group (OP pre: 51.13 ± 31.42%, post: 62.26 ± 31.45%, GP pre: 33.00 ± 19.60%, post: 31.14 ± 31.45%,  P  < 0.001). There were further group effects for 3RM squat (OP pre: 151.17 ± 22.95 kg, post: 162.17 ± 24.16 kg, GP pre: 156.43 ± 25.07 kg, post: 163.39 ± 25.39 kg,  P  < 0.001), peak power (OP pre: 3195 ± 949 W, post: 3552 ± 1033 W, GP pre: 3468 ± 911 W, post: 3591 ± 936 W,  P  < 0.001), and SJ (OP pre: 39.79 ± 7.80 cm, post: 42.69 ± 7.83 cm, GP pre: 40.44 ± 6.23 cm, post: 41.14 ± 5.66 cm,  P  < 0.001). Prescribing F-V deficit training is superior for improving physical performance within highly trained RL players.",2020,The effectiveness of 8-week force-velocity optimised training was assessed in highly trained professional rugby league athletes.,"['highly trained professional rugby league athletes', 'Players (age 24\xa0±\xa03\xa0years; body mass 94.9\xa0±\xa021.6 kg; height 181.3\xa0±\xa06.0 cm) were strength-matched and assigned to a', 'professional rugby league players']","['Prescribing F-V deficit training', 'force-velocity optimised group (OP;  n  =\xa015) or a general strength-power group (GP;  n  =\xa014', '8-week force-velocity optimised training']","['10-m, 20-m sprints, 3 repetition-maximum squat and squat jumps over five load conditions to ascertain vertical force-velocity relationship', 'force-velocity deficit', '3RM squat', 'physical performance']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0749672,The effectiveness of 8-week force-velocity optimised training was assessed in highly trained professional rugby league athletes.,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Simpson', 'Affiliation': 'School of Sport, Health and Applied Science, St Marys University , Twickenham, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Waldron', 'Affiliation': 'Research Centre in Applied Sports, Technology, Exercise and Medicine, College of Engineering, Swansea University , Swansea, Wales.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Cushion', 'Affiliation': 'School of Sport, Health and Applied Science, St Marys University , Twickenham, UK.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Tallent', 'Affiliation': 'School of Sport, Health and Applied Science, St Marys University , Twickenham, UK.'}]",Journal of sports sciences,['10.1080/02640414.2020.1805850']
2141,32799814,"Pain management after ambulatory surgery: a prospective, multicenter, randomized, double-blinded parallel controlled trial comparing nalbuphine and tramadol.","BACKGROUND


Postoperative pain in ambulatory surgery is a multifactorial issue affecting patient satisfaction, time of discharge, and rehospitalization. This study evaluated the efficacy and safety of nalbuphine for the treatment of postoperative pain after ambulatory surgery, relative to tramadol.
METHODS


This multi-center, randomized, double blind, and controlled study was conducted at 10 centers. In accordance with the inclusion criteria, 492 ambulatory surgery patients were recruited. These patients had moderate to severe pain after ambulatory surgery, with a visual analogue scale (VAS) score > 3 cm. They were randomly divided into an experimental (n = 248) or control (n = 244) group and treated for analgesia with 0.2 mg/kg of nalbuphine or 2 mg/kg of tramadol, respectively. VAS scores, adverse events, and vital signs of the patients were recorded before administration (baseline; T 1 ); and 30 min (T 2 ), 2 h (T 3 ), 4 h (T 4 ), and 6 h (T 5 ) after administration of analgesia. A decrease in pain intensity of more than 25% compared with the baseline was used as an indicator of analgesic efficacy. The experimental and control groups were compared with regard to this indicator of efficacy at each timepoint.
RESULTS


The VAS scores of the experimental and control groups were statistically comparable at timepoints T 1 -T 4 . At T 5 , the VAS scores of the experimental group were significantly lower than that of the control. The pain intensity was significantly higher in the experimental group compared with the control at T 2  and T 3 . Adverse events and vital signs were similar for the two groups at each timepoint.
CONCLUSIONS


Nalbuphine can provide effective and safe pain relief in patients after ambulatory surgery.
TRIAL REGISTRATION


The registration number is ChiCTR-IOR-16010032 , the date of registration was 2016-11-28.",2020,The pain intensity was significantly higher in the experimental group compared with the control at T 2  and T 3 .,"['after ambulatory surgery', '492 ambulatory surgery patients were recruited', 'patients had moderate to severe pain after ambulatory surgery, with a visual analogue scale (VAS) score\u2009>\u20093\u2009cm', 'patients after ambulatory surgery']","['control (n\u2009=\u2009244) group and treated for analgesia with 0.2\u2009mg/kg of nalbuphine or 2\u2009mg/kg of tramadol', 'Nalbuphine', 'nalbuphine', 'nalbuphine and tramadol']","['pain intensity', 'VAS scores, adverse events, and vital signs', 'analgesic efficacy', 'efficacy and safety', 'effective and safe pain relief', 'Adverse events and vital signs', 'Pain management', 'VAS scores']","[{'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",,0.341458,The pain intensity was significantly higher in the experimental group compared with the control at T 2  and T 3 .,"[{'ForeName': 'Yu-Jiao', 'Initials': 'YJ', 'LastName': 'Guan', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital of Central South University, No. 87 Xiangya Road, Changsha, Hunan, China.'}, {'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': ""Department of Anesthesiology, Hunan Provincial People's Hospital, Changsha, Hunan, China.""}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Liao', 'Affiliation': 'Department of Anesthesiology, Third Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Qi-Wu', 'Initials': 'QW', 'LastName': 'Fang', 'Affiliation': 'Department of Anesthesiology, Pain Medicine & Critical Care Medicine, Aviation General Hospital of China Medical University & Beijing Institute of Translational Medicine, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, Peking University Shougang Hospital, Beijing, China.'}, {'ForeName': 'Chong-Fang', 'Initials': 'CF', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, Shanxi Academy of Medical Sciences, Shanxi Dayi Hospital, Shanxi, China.'}, {'ForeName': 'Chang-Hong', 'Initials': 'CH', 'LastName': 'Miao', 'Affiliation': 'Department of Anesthesiology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Gang-Jian', 'Initials': 'GJ', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Han-Bing', 'Initials': 'HB', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, First People's Hospital of Foshan, Foshan, Guangdong, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, Beijing Ditan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Qu-Lian', 'Initials': 'QL', 'LastName': 'Guo', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital of Central South University, No. 87 Xiangya Road, Changsha, Hunan, China. qulianguo@hotmail.com.'}, {'ForeName': 'Zhi-Gang', 'Initials': 'ZG', 'LastName': 'Cheng', 'Affiliation': 'Department of Anesthesiology, Xiangya Hospital of Central South University, No. 87 Xiangya Road, Changsha, Hunan, China. chengzg2004@hotmail.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01125-4']
2142,32799841,The efficacy and safety of peripheral intravenous parenteral nutrition vs 10% glucose in preterm infants born 30 to 33 weeks' gestation: a randomised controlled trial.,"BACKGROUND


Preterm infants born 30 to 33 weeks' gestation often require early support with intravenous fluids because of respiratory distress, hypoglycemia or feed intolerance. When full feeds are anticipated to be reached within the first week, risks associated with intravenous delivery mode and type must be carefully considered. Recommendations are for parenteral nutrition to be infused via central venous lines (because of the high osmolarity), however, given the risks associated with central lines, clinicians may opt for 10% glucose via peripheral venous catheter when the need is short-term. We therefore compare a low osmolarity peripheral intravenous parenteral nutrition (P-PN) solution with peripheral intravenous 10% glucose on growth rate in preterm infants born 30 to 33 weeks' gestation.
METHODS


In this parallel group, single centre, superiority, non-blinded, randomised controlled trial, 92 (P-PN 42, control 50) infants born 30 + 0  to 33 + 6  weeks' gestation, were randomised within 24 h of age, to receive either P-PN (8% glucose, 30 g/L amino acids, 500 IU/L heparin and SMOFlipid®) or a control of peripheral intravenous 10% glucose. Both groups received enteral feeds according to hospital protocol. The primary outcome was rate of weight gain from birth to 21 days of age.
RESULTS


The rate of weight gain was significantly increased in P-PN infants compared with control (P-PN, n = 42, 18.7, SD 6.6 g/d vs control, n = 50, 14.8, SD 6.0 g/d; adjusted mean difference 3.9 g/d, 95% CI 1.3 to 6.6; P = 0.004), with the effect maintained to discharge home. Days to regain birthweight were significantly reduced and length gain significantly increased in P-PN infants. One infant in the P-PN group had a stage 3 extravasation which rapidly resolved. Blood urea nitrogen and triglyceride levels were significantly higher in the P-PN group in the first week of life, but there were no instances of abnormally high levels. There were no significant differences in any other clinical or biochemical outcomes.
CONCLUSION


P-PN improves the rate of weight gain to discharge home in preterm infants born 30 to 33 weeks gestation compared with peripheral intravenous 10% glucose.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry ACTRN12616000925448 . Registered 12 July 2016.",2020,"Blood urea nitrogen and triglyceride levels were significantly higher in the P-PN group in the first week of life, but there were no instances of abnormally high levels.","[""preterm infants born 30 to 33\u2009weeks' gestation"", ""Preterm infants born 30 to 33\u2009weeks' gestation often require early support with intravenous fluids because of respiratory distress, hypoglycemia or feed intolerance""]","['P-PN', 'low osmolarity peripheral intravenous parenteral nutrition (P-PN) solution with peripheral intravenous 10% glucose', 'P-PN (8% glucose, 30\u2009g/L amino acids, 500\u2009IU/L heparin and SMOFlipid®) or a control of peripheral intravenous 10% glucose', 'enteral feeds', 'peripheral intravenous parenteral nutrition']","['rate of weight gain from birth to 21\u2009days of age', 'length gain', 'rate of weight gain', 'Blood urea nitrogen and triglyceride levels', 'efficacy and safety', 'growth rate']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439457', 'cui_str': 'mIU/mL'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}]",,0.426109,"Blood urea nitrogen and triglyceride levels were significantly higher in the P-PN group in the first week of life, but there were no instances of abnormally high levels.","[{'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Suganuma', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Bonney', 'Affiliation': ""Neonatal Medicine, Women's and Children's Hospital, Adelaide, SA, Australia.""}, {'ForeName': 'Chad C', 'Initials': 'CC', 'LastName': 'Andersen', 'Affiliation': ""Neonatal Medicine, Women's and Children's Hospital, Adelaide, SA, Australia.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'McPhee', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Sullivan', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Gibson', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia.'}, {'ForeName': 'Carmel T', 'Initials': 'CT', 'LastName': 'Collins', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute Adelaide, South Australia, Australia. carmel.collins@sahmri.com.'}]",BMC pediatrics,['10.1186/s12887-020-02280-w']
2143,32799849,"Protocol for Minute Calisthenics: a randomized controlled study of a daily, habit-based, bodyweight resistance training program.","BACKGROUND


Resistance-training (RT) provides significant health benefits. However, roughly 3/4 of adults in the United States do not meet current Physical Activity Guidelines in this regard. There has been a call for research examining the effectiveness of interventions to increase participation in physical activity and to better understand the dose response relationship upon health outcomes. Studies are needed that assess the effectiveness of RT programs that are time-efficient and simple to perform. This fully-powered, randomized controlled study will assess a habit-based RT program consisting of one set of push-ups, angled-rows, and bodyweight-squats performed every weekday for 12-24 weeks in untrained individuals.
METHODS


Forty-60 untrained osteopathic medical students and college/university employees who work in an office setting will be recruited and randomized (1:1) to an intervention or waitlist control group. After 12-week follow-up assessment, the intervention group will continue the program and the control group will initiate the program for 12 weeks. In addition to the equipment and training needed to safely perform the exercises, all participants will receive training in the Tiny Habits® Method (THM) and digital coaching for the duration of the study. Participants will complete weekly assessments regarding the program during their initial 12-week intervention phase. The primary outcome is the change from baseline to 12 weeks in the intervention group versus the control group, in the combined number of repetitions performed in one set of each of the three exercises (composite repetitions) under a standardized protocol. Secondary outcomes include adherence to and satisfaction with the program, and change from baseline to 12- and 24-week follow-up in blood pressure, fasting lipid panel, hemoglobin A1c, body mass index, anthropometry, body composition, mid-thigh muscle thickness, and habit strength.
DISCUSSION


This study will evaluate a simple, habit-based RT intervention in untrained individuals. The approach is unique in that it utilizes brief but frequent bodyweight exercises and, via the THM, focuses on consistency and habit formation first, with effort being increased as participants are motivated and able. If effective, the program can be easily scaled for wider adoption.
TRIAL REGISTRATION


This study was prospectively registered at ClinicalTrials.gov, identifier NCT04207567 , on December 23rd, 2019.",2020,"The primary outcome is the change from baseline to 12 weeks in the intervention group versus the control group, in the combined number of repetitions performed in one set of each of the three exercises (composite repetitions) under a standardized protocol.","['Forty-60 untrained osteopathic medical students and college/university employees who work in an office setting will be recruited and randomized (1:1) to an', 'untrained individuals']","['intervention or waitlist control group', 'habit-based, bodyweight resistance training program', 'habit-based RT intervention', 'training in the Tiny Habits® Method (THM) and digital coaching', 'Resistance-training (RT']","['adherence to and satisfaction with the program, and change from baseline to 12- and 24-week follow-up in blood pressure, fasting lipid panel, hemoglobin A1c, body mass index, anthropometry, body composition, mid-thigh muscle thickness, and habit strength']","[{'cui': 'C0419203', 'cui_str': 'Osteopathy'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0430044', 'cui_str': 'Fasting lipid profile'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0224416', 'cui_str': 'Skeletal muscle structure of thigh'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",,0.037425,"The primary outcome is the change from baseline to 12 weeks in the intervention group versus the control group, in the combined number of repetitions performed in one set of each of the three exercises (composite repetitions) under a standardized protocol.","[{'ForeName': 'Joshua C', 'Initials': 'JC', 'LastName': 'Hollingsworth', 'Affiliation': 'Edward Via College of Osteopathic Medicine - Auburn Campus, 910 South Donahue Drive, Auburn, AL, 36832, USA. jhollingsworth@auburn.vcom.edu.'}, {'ForeName': 'Kaelin C', 'Initials': 'KC', 'LastName': 'Young', 'Affiliation': 'Edward Via College of Osteopathic Medicine - Auburn Campus, 910 South Donahue Drive, Auburn, AL, 36832, USA.'}, {'ForeName': 'Siraj F', 'Initials': 'SF', 'LastName': 'Abdullah', 'Affiliation': 'Edward Via College of Osteopathic Medicine - Auburn Campus, 910 South Donahue Drive, Auburn, AL, 36832, USA.'}, {'ForeName': 'Danielle D', 'Initials': 'DD', 'LastName': 'Wadsworth', 'Affiliation': 'Auburn University, School of Kinesiology, 301 Wire Road, Auburn, AL, 36849, USA.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Abukhader', 'Affiliation': 'Edward Via College of Osteopathic Medicine - Auburn Campus, 910 South Donahue Drive, Auburn, AL, 36832, USA.'}, {'ForeName': 'Bari', 'Initials': 'B', 'LastName': 'Elfenbein', 'Affiliation': 'Edward Via College of Osteopathic Medicine - Auburn Campus, 910 South Donahue Drive, Auburn, AL, 36832, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Holley', 'Affiliation': 'Edward Via College of Osteopathic Medicine - Auburn Campus, 910 South Donahue Drive, Auburn, AL, 36832, USA.'}]",BMC public health,['10.1186/s12889-020-09355-4']
2144,32799851,Efficacy of single high-molecular-weight versus triple low-molecular-weight hyaluronic acid intra-articular injection among knee osteoarthritis patients.,"BACKGROUND


To compare intra-articular (IA) knee injections of a cross-linked high-molecular-weight hyaluronic acid (HMW-HA) with a linear low-molecular weight HA (LMW-HA) in terms of pain and functional improvement among knee osteoarthritis (OA) patients.
METHODS


In this single-blinded RCT, the patients were randomly divided into two groups for HA injections. The first group received an HMW-HA (Arthromac) injection, while the other received three weekly LMW-HA (Hyalgan) injections. Pain and function were assessed using the outcome measures including WOMAC, Lequesne and VAS indices, once prior to injection, as well as 2 and 6 months after injections.
RESULTS


A total of 90 patients were included. There was no significant difference in baseline characteristics including age and sex between the two groups. Our analysis showed that total WOMAC, Lequesne and VAS mean scores remarkably improved at both follow-up time-points compared to the baseline measurements (p < 0.001). There was no significant superiority between the two therapeutic protocols according to our outcome measures at any time-point of follow-up. The only except was about the improvement in WOMAC stiffness subscale that was significantly higher in LMW-HA group compared to HMW-HA (p = 0.021). Moreover, no significant difference was observed in minor complications and injection-induced pain scores between the two groups.
CONCLUSION


This study proved that a single HMW-HA injection is as effective as multiple injections of LMW-HA counterparts in periods of 2 and 6 months follow-up. This study protocol was registered in Iranian database of RCTs (IRCT; www.irct.ir ) with the trial registration number IRCT20130523013442N24 and registration date 2018-07-13.",2020,"Our analysis showed that total WOMAC, Lequesne and VAS mean scores remarkably improved at both follow-up time-points compared to the baseline measurements (p < 0.001).","['knee osteoarthritis (OA) patients', 'knee osteoarthritis patients', 'A total of 90 patients were included', 'Iranian database of RCTs (IRCT; www.irct.ir ) with the trial registration number IRCT20130523013442N24 and registration date 2018-07-13']","['HMW-HA (Arthromac) injection, while the other received three weekly LMW-HA (Hyalgan) injections', 'HMW-HA injection', 'single high-molecular-weight versus triple low-molecular-weight hyaluronic acid intra-articular injection']","['total WOMAC, Lequesne and VAS mean scores', 'minor complications and injection-induced pain scores', 'WOMAC stiffness subscale', 'Pain and function', 'WOMAC, Lequesne and VAS indices, once prior to injection']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011008', 'cui_str': 'Date'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026385', 'cui_str': 'Molecular Weight'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451868', 'cui_str': 'Localized osteoporosis - Lequesne'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332152', 'cui_str': 'Before'}]",90.0,0.0733106,"Our analysis showed that total WOMAC, Lequesne and VAS mean scores remarkably improved at both follow-up time-points compared to the baseline measurements (p < 0.001).","[{'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Bahrami', 'Affiliation': 'Physical Medicine and Rehabilitation Department and Research Center, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, School of Medicine, Tehran, Iran.'}, {'ForeName': 'Seyed Ahmad', 'Initials': 'SA', 'LastName': 'Raeissadat', 'Affiliation': 'Clinical Development Research Center of Shahid Modarres Hospital, Physical Medicine and Rehabilitation Department and Research Center, Shahid Beheshti University of Medical Sciences, School of Medicine, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Cheraghi', 'Affiliation': 'Physical Medicine and Rehabilitation Department and Research Center, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, School of Medicine, Tehran, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Rahimi-Dehgolan', 'Affiliation': 'Physical Medicine and Rehabilitation Department, Tehran University of Medical Sciences (TUMS), School of Medicine, Tehran, Iran.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Ebrahimpour', 'Affiliation': 'Orthopedic surgery Department, Taleghani Hospital, Shahid Beheshti University of Medical Sciences, School of Medicine, No. 1998734383, Velenjak, Tehran, Iran. a.ebrahimpour@sbmu.ac.ir.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03577-8']
2145,32795597,Racial disparities in out-of-hospital cardiac arrest interventions and survival in the Pragmatic Airway Resuscitation Trial.,"BACKGROUND


Prior studies have reported racial disparities in survival from out-of-hospital cardiac arrest (OHCA). However, these studies did not evaluate the association of race with OHCA course of care and outcomes. The purpose of this study was to evaluate racial disparities in OHCA airway placement success and patient outcomes in the multicenter Pragmatic Airway Resuscitation Trial (PART).
METHOD


We conducted a secondary analysis of adult OHCA patients enrolled in PART. The parent trial randomized subjects to initial advanced airway management with laryngeal tube or endotracheal intubation. For this analysis, the primary independent variable was patient race categorized by emergency medical services (EMS) as white, black, Hispanic, other, and unknown. We used general estimating equations to examine the association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster.
RESULTS


Of 3002 patients, EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown. Initial shockable rhythms (13.8% vs. 21.5%, p < 0.001), bystander CPR (35.6% vs. 51.4%, p < 0.001), and survival to hospital discharge (7.6% vs. 10.8%, p = 0.011) were lower for black compared to white patients. After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
CONCLUSIONS


In one of the largest studies evaluating differences in prehospital airway interventions and outcomes by EMS-assessed race for OHCA patients, we found no significant adjusted differences between airway success or survival outcomes.",2020,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[' EMS-assessed race as 1537 white, 860 black, 163 Hispanic, 90 other, and 352 unknown', '3002 patients', 'adult OHCA patients enrolled in PART']",['initial advanced airway management with laryngeal tube or endotracheal intubation'],"['association of race with airway attempt success, 72-h survival, and survival to hospital discharge, adjusting for sex, age, witness status, bystander cardiopulmonary resuscitation (CPR), initial rhythm, arrest location, and PART randomization cluster', 'airway success, 72-h survival, and survival to hospital discharge by race', 'Initial shockable rhythms', 'survival to hospital discharge', 'bystander CPR', 'airway success or survival outcomes']","[{'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",3002.0,0.089249,"After adjustment for confounders, no difference was seen in airway success, 72-h survival, and survival to hospital discharge by race.
","[{'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lupton', 'Affiliation': 'Oregon Health & Science University, United States. Electronic address: lupton@ohsu.edu.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Schmicker', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Tom P', 'Initials': 'TP', 'LastName': 'Aufderheide', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Blewer', 'Affiliation': 'Duke University School of Medicine, United States.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Callaway', 'Affiliation': 'University of Pittsburgh School of Medicine, United States.'}, {'ForeName': 'Jestin N', 'Initials': 'JN', 'LastName': 'Carlson', 'Affiliation': 'Allegheny Health Network, United States.'}, {'ForeName': 'M Riccardo', 'Initials': 'MR', 'LastName': 'Colella', 'Affiliation': 'Medical College of Wisconsin, United States.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Hansen', 'Affiliation': 'Oregon Health & Science University, United States.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Herren', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Nichol', 'Affiliation': 'University of Washington School of Medicine, United States.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'University of Texas Health Science Center at Houston, United States.'}, {'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Oregon Health & Science University, United States.'}]",Resuscitation,['10.1016/j.resuscitation.2020.08.004']
2146,32795619,Three-year results of a randomized controlled trial comparing mechanochemical and thermal ablation in the treatment of insufficient great saphenous veins.,"OBJECTIVES


Mechanochemical ablation (MOCA) is a non-thermal non-tumescent method of treating saphenous vein insufficiency. The feasibility and short-term results of MOCA are good, but its long-term results are unknown. A randomized study was performed to compare MOCA with endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) in the setting of unilateral GSV insufficiency.
METHODS


Venous outpatient clinic patients with varicose veins (CEAP class C2-4) caused by GSV insufficiency were invited to participate in the study; in total, 132 patients filled the inclusion criteria and were willing to participate. Patients were randomized to treatment (2:1:1 for MOCA, EVLA, and RFA, respectively). The state of the GSV with duplex Doppler ultrasound examination and the disease-specific quality of life were assessed at one month, one year, and three years after the treatment.
RESULTS


Some patients declined to continue in the study after randomization; in total, 117 patients underwent treatment. At three years, the occlusion rate was significantly lower with MOCA than with either EVLA or RFA (82% vs. 100%, P = 0.005). Quality of life was similar between the groups. In the MOCA group, GSV's that were preoperatively over 7 mm in diameter were more likely to recanalize during the follow-up period. The partial recanalizations of proximal GSV observed at one year progressed during the follow-up.
CONCLUSIONS


MOCA is a feasible treatment option for outpatient setting, but its technical success rates are inferior compared to endovenous thermal ablation. Its use in large calibre veins should be carefully considered.",2020,Quality of life was similar between the groups.,"['117 patients underwent treatment', 'Venous outpatient clinic patients with varicose veins (CEAP class C2-4) caused by GSV insufficiency were invited to participate in the study; in total, 132 patients filled the inclusion criteria and were willing to participate', 'insufficient great saphenous veins']","['MOCA', 'Mechanochemical ablation (MOCA', 'EVLA', 'MOCA with endovenous laser ablation (EVLA) and radiofrequency ablation (RFA', 'mechanochemical and thermal ablation']","['disease-specific quality of life', 'Quality of life', 'partial recanalizations of proximal GSV', 'occlusion rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0392907', 'cui_str': 'Great saphenous vein structure'}]","[{'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0677798', 'cui_str': 'Thermal ablation'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]",132.0,0.0265649,Quality of life was similar between the groups.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vähäaho', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland. Electronic address: sari.vahaaho@fimnet.fi.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Halmesmäki', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Mahmoud', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Albäck', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Noronen', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Venermo', 'Affiliation': 'Department of Vascular Surgery, Helsinki University Hospital, Helsinki University, Helsinki, Finland.'}]",Journal of vascular surgery. Venous and lymphatic disorders,['10.1016/j.jvsv.2020.08.007']
2147,32795623,Effects of flexibility and strength training on peak hamstring musculotendinous strains during sprinting.,"PURPOSE


Hamstring injury is one of the most common injuries in sports involving sprinting. Hamstring flexibility and strength are often considered as modifiable risk factors for hamstring injury. Understanding the effects of hamstring flexibility or strength training on the biomechanics of the hamstring muscles during sprinting could assist in improving prevention strategies and rehabilitation of these injuries. The purpose of this study was to determine the effects of altering hamstring flexibility or strength on peak hamstring musculotendinous strain during sprinting.
METHODS


A total of 20 male college students (aged 18-24 years) participated and were randomly assigned to either a flexibility intervention group or a strength intervention group. Each participant executed exercise training 3 times a week for 8 weeks. Flexibility, sprinting and isokinetic strength testing were performed before and after the 2 interventions. Paired t-tests were performed to determine hamstring flexibility or strength intervention effects on hamstring optimal musculotendinous lengths and peak hamstring musculotendinous strains during sprinting.
RESULTS


Participants in the flexibility intervention group significantly increased optimal musculotendinous lengths of the semimembranosus and biceps long head (p ≤ 0.026) and decreased peak musculotendinous strains of all 3 bi-articulate hamstring muscles (p ≤ 0.004). Participants in the strength intervention group significantly increased optimal musculotendinous lengths of all 3 hamstring muscles (p ≤ 0.041) and significantly decreased their peak musculotendinous strain during sprinting (p ≤ 0.017).
CONCLUSION


Increasing hamstring flexibility or strength through exercise training may assist in reducing the risk of hamstring injury during sprinting for recreational male athletes.",2020,"Participants in the strength intervention group significantly increased optimal musculotendinous lengths of all 3 hamstring muscles (p ≤ 0.041) and significantly decreased their peak musculotendinous strain during sprinting (p ≤ 0.017).
","['peak hamstring musculotendinous strains during sprinting', '20 male college students (aged 18-24 years', 'recreational male athletes']","['exercise training', 'flexibility intervention group or a strength intervention group', 'flexibility and strength training', 'hamstring flexibility or strength', 'hamstring flexibility or strength training']","['peak musculotendinous strains', 'peak musculotendinous strain', 'Hamstring flexibility and strength', 'optimal musculotendinous lengths of the semimembranosus and biceps long head', 'optimal musculotendinous lengths of all 3 hamstring muscles', 'Flexibility, sprinting and isokinetic strength testing']","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0224452', 'cui_str': 'Semimembranosus muscle structure'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]",20.0,0.0138512,"Participants in the strength intervention group significantly increased optimal musculotendinous lengths of all 3 hamstring muscles (p ≤ 0.041) and significantly decreased their peak musculotendinous strain during sprinting (p ≤ 0.017).
","[{'ForeName': 'Xianglin', 'Initials': 'X', 'LastName': 'Wan', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Shangxiao', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Best', 'Affiliation': 'UHealth Sports Medicine Institute, University of Miami, Miami, FL 33136, USA.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China.'}, {'ForeName': 'Hanjun', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Biomechanics Laboratory, Beijing Sport University, Beijing 100084, China. Electronic address: lihanjun@bsu.edu.cn.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Center for Human Movement Science, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599-7135, USA. Electronic address: byu@med.unc.edu.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.08.001']
2148,32795738,Predictors of receptivity to an alcohol intervention among mandated students.,"OBJECTIVE


Students in violation of campus alcohol policy often must participate in an alcohol risk reduction intervention, and some mandated students express overt resistance to change. This study tested a priori hypotheses about psychological variables that might predict receptivity to an online brief alcohol intervention.
METHOD


Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations. Before their mandated online alcohol intervention, they completed a baseline assessment consisting of demographics and questionnaires about their alcohol use, attitudes toward moderate and heavy drinking, beliefs about the centrality of alcohol in college life, perceived descriptive and injunctive drinking norms, trait defensiveness, social desirability and response to the event leading to their sanction. They also responded to a set of questions about how interested in, open-minded, and likely to benefit they were from the computer-delivered alcohol intervention they were about to take.
RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
CONCLUSIONS


Among students mandated to participate in an alcohol intervention, openness to benefitting from the intervention varies in predictable ways. Because intervention receptiveness is associated with post-intervention change, we offer suggestions to tailor mandated interventions in ways that might improve outcomes.",2020,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","['Participants were 193 students (56% male, 88% underclassmen, 70% white) who were referred to the campus Office of Alcohol and Other Drugs after being cited for alcohol policy violations', 'mandated students']",['alcohol intervention'],"['heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1515187', 'cui_str': 'Take'}]",193.0,0.0120224,"RESULTS


Controlling for covariates and all other predictors, greater receptivity to intervention was predicted by heavier alcohol consumption, positive attitude towards moderate drinking, perceptions that peers were less approving of heavy drinking, and taking personal responsibility for the incident.
","[{'ForeName': 'Kate B', 'Initials': 'KB', 'LastName': 'Carey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Behavioral and Social Sciences, Brown University School of Public Health, United States. Electronic address: Kate_Carey@Brown.edu.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'DiBello', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States; Department of Psychology, City University of New York, Brooklyn College, United States.'}, {'ForeName': 'Elora E', 'Initials': 'EE', 'LastName': 'Orazio', 'Affiliation': 'College of Community and Public Affairs, Binghamton University, United States.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Hatch', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, United States.'}, {'ForeName': 'Nadine R', 'Initials': 'NR', 'LastName': 'Mastroleo', 'Affiliation': 'Department of Psychology, Binghamton University, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106605']
2149,32795925,Relationship between antofloxacin concentration and QT prolongation and estimation of the possible false-positive rate.,"PURPOSE


To elucidate the relationship between antofloxacin (AT) plasma concentration and QT interval prolongation, compare the effects of different correction and analytical methods on conclusions, and estimate the possible false-positive rate in thorough QT (TQT) studies.
METHODS


Twenty-four healthy Chinese volunteers from a four-period crossover TQT study orally received 200 mg/d AT, 400 mg/d AT, 400 mg/d moxifloxacin, and a placebo in a random order for 5 d for each. QT interval samples were collected on d 1 and d 5. Population models were established describing the relationship between QT and AT concentration. The yardstick from ICH E14 guidelines was used to measure the effect of drugs on QT prolongation both in biostatistical and modeling analyses. A possible false-positive rate was estimated by constructing a 1000-time bootstrap to obtain the rate-of-difference values between d 1 and d 5 over 5 ms in the placebo period.
RESULTS


In the modeling analysis, the QT prolongation estimate at the mean maximal concentration of AT (4.51 μg/mL) was 3.84 ms, and its upper bound of the one-sided 95 % CI was 7.04 ms, which showed a negative effect on QT interval prolongation. The estimation for the false-positive rate was 31 % in this study.
CONCLUSION


The effect of AT on QT interval prolongation may not have been significant at the dosage of 400 mg. Baseline and placebo adjustments were necessary in TQT studies. Population modeling has demonstrated clear superiority in making full use of data to accurately analyze the relationship between drugs and QT intervals.",2020,"In the modeling analysis, the QT prolongation estimate at the mean maximal concentration of AT (4.51 μg/mL) was 3.84 ms, and its upper bound of the one-sided 95 % CI was 7.04 ms, which showed a negative effect on QT interval prolongation.",['Twenty-four healthy Chinese volunteers from a four-period crossover'],"['TQT study orally received 200\u2009mg/d AT, 400\u2009mg/d AT, 400\u2009mg/d moxifloxacin, and a placebo', 'placebo']","['false-positive rate', 'antofloxacin concentration and QT prolongation and estimation of the possible false-positive rate', 'antofloxacin (AT) plasma concentration and QT interval prolongation', 'QT interval samples', 'QT interval prolongation']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C2002223', 'cui_str': 'antofloxacin'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C2002223', 'cui_str': 'antofloxacin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0151878', 'cui_str': 'Prolonged QT interval'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",24.0,0.0861305,"In the modeling analysis, the QT prolongation estimate at the mean maximal concentration of AT (4.51 μg/mL) was 3.84 ms, and its upper bound of the one-sided 95 % CI was 7.04 ms, which showed a negative effect on QT interval prolongation.","[{'ForeName': 'Li-Yu', 'Initials': 'LY', 'LastName': 'Liang', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Ying-Chun', 'Initials': 'YC', 'LastName': 'He', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Yun-Fei', 'Initials': 'YF', 'LastName': 'Li', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Feng-Yan', 'Initials': 'FY', 'LastName': 'Xu', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Lu-Jin', 'Initials': 'LJ', 'LastName': 'Li', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.'}, {'ForeName': 'Ji-Han', 'Initials': 'JH', 'LastName': 'Huang', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: huangjihan@shutcm.edu.cn.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: kunwang@139.com.'}, {'ForeName': 'Qing-Shan', 'Initials': 'QS', 'LastName': 'Zheng', 'Affiliation': 'Center for Drug Clinical Research, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. Electronic address: qingshan.zheng@drugchina.net.'}]",Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie,['10.1016/j.biopha.2020.110619']
2150,32795983,Text Messaging Adherence Intervention for Adolescents and Young Adults with Chronic Kidney Disease: Pilot Randomized Controlled Trial and Stakeholder Interviews.,"BACKGROUND


Up to one-third of adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications. Mobile health interventions may promote higher adherence to these medicines in these individuals, but empirical research is needed to inform best practices for applying these modalities.
OBJECTIVE


In this multiphase investigation, we developed and tested a theoretically informed text messaging intervention based on the COM-B model, a well-established health intervention framework stating that capability, opportunity, and motivation interactively modify health behaviors, to improve participants' antihypertensive medication adherence in a pilot randomized controlled trial. Qualitative data on user experiences were obtained.
METHODS


In phase 1, intervention messages (Reminder+COM-B Message) were developed via stakeholder engagement of participants and pediatric nephrologists. In phase 2, the Reminder+COM-B Message intervention was tested against a Reminder-only Message active control condition in an 8-week pilot randomized controlled trial. The primary outcome was daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine. In phase 3, qualitative interviews related to user experiences were conducted with participants in the Reminder+COM-B Message intervention group.
RESULTS


Following phase 1, 34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis) completed the phase 2 pilot randomized controlled trial (n=18 in the Reminder+COM-B Message intervention group, n=16 in the Reminder-only Message active control group). All participants in the Reminder+COM-B Message intervention group completed a phase 3 qualitative interview. Overall, study procedures were feasible and the Reminder+COM-B Message intervention was acceptable to the participants (eg, 15/18 participants reported reading the majority of messages sent to them, 0/18 reported that the messages reduced their desire to take medicine). Prerandomization, there were no significant group differences in the rate of change in daily adherence over time. However, postrandomization, there was a significant group by time interaction (B=.01, P=.04) in which daily adherence decreased significantly over time in the Reminder-only Message active control group but remained stable in the Reminder+COM-B Message intervention group. There were no significant differences between groups in pre-post changes in survey responses. Qualitative interviews revealed participants' perceptions of how the Reminder+COM-B Message intervention changed adherence behavior and highlighted several areas for improving the intervention (eg, adapt messaging timing, intensity, and content to match daily adherence, send praise when medicine is taken).
CONCLUSIONS


The Reminder+COM-B Message intervention was feasible and acceptable to adolescents/young adults and demonstrated potential to promote participants' daily medication adherence beyond simple reminders. Further research is needed to determine the Reminder+COM-B Message intervention's mechanisms of adherence behavior change and to incorporate qualitative participant feedback into a modified version of this intervention to enhance its acceptability.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03651596; https://clinicaltrials.gov/ct2/show/NCT03651596.",2020,There were no significant differences between groups in pre-post changes in survey responses.,"['adolescents and young adults (11-21 years old) with chronic kidney disease exhibit suboptimal rates of adherence to renal-protective antihypertensive medications', '34 participants (mean age 16.59 years, 41% female, 38% African American/Black, 35% hypertension diagnosis', 'Adolescents and Young Adults with Chronic Kidney Disease']","['Text Messaging Adherence Intervention', 'Reminder+COM-B Message intervention group', 'Mobile health interventions', 'Reminder+COM-B Message intervention']","['daily adherence', 'time interaction', 'rate of change in daily adherence', 'desire to take medicine', 'daily electronically monitored antihypertensive medication adherence and secondary outcomes included pre-post participant surveys of adherence self-efficacy, adherence barriers, outcome expectancies for taking medicine, and motivation for and importance of taking medicine']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.177456,There were no significant differences between groups in pre-post changes in survey responses.,"[{'ForeName': 'Cyd', 'Initials': 'C', 'LastName': 'Eaton', 'Affiliation': 'Pulmonary & Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Comer', 'Affiliation': 'Pulmonary & Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Cozumel', 'Initials': 'C', 'LastName': 'Pruette', 'Affiliation': 'Division of Pediatric Nephrology, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Psoter', 'Affiliation': 'Division of General Pediatrics, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Riekert', 'Affiliation': 'Pulmonary & Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.'}]",Journal of medical Internet research,['10.2196/19861']
2151,32795986,Comparing Methods of Recruiting Spanish-Preferring Smokers in the United States: Findings from a Randomized Controlled Trial.,"BACKGROUND


There is a pressing need to address the unacceptable disparities and underrepresentation of racial and ethnic minority groups, including Hispanics or Latinxs, in smoking cessation trials.
OBJECTIVE


Given the lack of research on recruitment strategies for this population, this study aims to assess effective recruitment methods based on enrollment and cost.
METHODS


Recruitment and enrollment data were collected from a nationwide randomized controlled trial (RCT) of a Spanish-language smoking cessation intervention (N=1417). The effectiveness of each recruitment strategy was evaluated by computing the cost per participant (CPP), which is the ratio of direct cost over the number enrolled. More effective strategies yielded lower CPPs. Demographic and smoking-related characteristics of participants recruited via the two most effective strategies were also compared (n=1307).
RESULTS


Facebook was the most effective method (CPP=US $74.12), followed by TV advertisements (CPP=US $191.31), whereas public bus interior card advertising was the least effective method (CPP=US $642.50). Participants recruited via Facebook had lower average age (P=.008) and had spent fewer years in the United States (P<.001). Among the participants recruited via Facebook, a greater percentage of individuals had at least a high school education (P<.001) and an annual income above US $10,000 (P<.001). In addition, a greater percentage of individuals were employed (P<.001) and foreign born (P=.003). In terms of subethnicity, among the subjects recruited via Facebook, a lower percentage of individuals were of Mexican origin (P<.001) and a greater percentage of individuals were of Central American (P=.02), South American (P=.01), and Cuban (P<.001) origin.
CONCLUSIONS


Facebook was the most effective method for recruiting Hispanic or Latinx smokers in the United States for this RCT. However, using multiple methods was necessary to recruit a more diverse sample of Spanish-preferring Hispanic or Latinx smokers.",2020,Participants recruited via Facebook had lower average age (P=.008) and had spent fewer years in the United States (P<.001).,"['Participants recruited via Facebook had lower average age (P=.008) and had spent fewer years in the United States (P<.001', 'participants recruited via Facebook, a greater percentage of individuals had at least a high school education (P<.001) and an annual income above US $10,000 (P<.001', 'Recruitment and enrollment data were collected from a nationwide randomized controlled trial (RCT) of a Spanish-language smoking cessation intervention (N=1417']",[],[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0455002', 'cui_str': 'Education and schooling detail'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],[],,0.183879,Participants recruited via Facebook had lower average age (P=.008) and had spent fewer years in the United States (P<.001).,"[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Medina-Ramirez', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Calixte-Civil', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Meltzer', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Karen O', 'Initials': 'KO', 'LastName': 'Brandon', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Martinez', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Sutton', 'Affiliation': 'Department of Psychology, University of South Florida, Tampa, FL, United States.'}, {'ForeName': 'Cathy D', 'Initials': 'CD', 'LastName': 'Meade', 'Affiliation': 'Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Byrne', 'Affiliation': 'Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Brandon', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}, {'ForeName': 'Vani N', 'Initials': 'VN', 'LastName': 'Simmons', 'Affiliation': 'Tobacco Research & Intervention Program, Department of Health Outcomes & Behavior, Moffitt Cancer Center & Research Institute, Tampa, FL, United States.'}]",Journal of medical Internet research,['10.2196/19389']
2152,32795987,The Effect of Improved Access to Family Planning on Postpartum Women: Protocol for a Randomized Controlled Trial.,"BACKGROUND


The World Health Organization recommends that a woman waits at least 24 months after a live birth before getting pregnant again; however, an estimated 25% of birth intervals in low-income countries do not meet this recommendation for adequate birth spacing, and the unmet need for postpartum family planning (PPFP) services is high. Few randomized controlled trials have assessed the causal impact of access to PPFP services, and even fewer evaluations have investigated how such interventions may affect postpartum contraceptive use, birth spacing, and measures of health and well-being.
OBJECTIVE


This protocol paper aims to describe a randomized controlled trial that is being conducted to identify the causal impact of an intervention to improve access to PPFP services on contraceptive use, pregnancy, and birth spacing in urban Malawi. The causal effect of the intervention will be determined by comparing outcomes for respondents who are randomly assigned to an intervention arm against outcomes for respondents who are randomly assigned to a control arm.
METHODS


Married women aged 18-35 years who were either pregnant or had recently given birth were randomly assigned to either the intervention arm or control arm. Women assigned to the intervention arm received a package of services over a 2-year intervention period. Services included a brochure and up to 6 home visits from trained family planning counselors; free transportation to a high-quality family planning clinic; and financial reimbursement for family planning services, consultations, and referrals for services. Two follow-up surveys were conducted 1 and 2 years after the baseline survey.
RESULTS


A total of 2143 women were randomly assigned to either the intervention arm (n=1026) or the control arm (n=1117). Data collection for the first follow-up survey began in August 2017 and was completed in February 2018. A total of 1773 women, or 82.73% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the first follow-up. Data collection for the second follow-up survey began in August 2018 and was completed in February 2019. A total of 1669 women, or 77.88% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the second follow-up. The analysis of the primary outcomes is ongoing and is expected to be completed in 2021.
CONCLUSIONS


The results of this trial seek to fill the current knowledge gaps in the effectiveness of family planning interventions on improving fertility and health outcomes. The findings also show that the benefits of improving access to family planning are likely to extend beyond the fertility and health domain by improving other measures of women's well-being.
TRIAL REGISTRATION


American Economics Association Registry Trial Number AEARCTR-0000697; https://www.socialscienceregistry.org/trials/697 Registry for International Development Impact Evaluations (RIDIE) Trial Number RIDIE-STUDY-ID-556784ed86956; https://ridie.3ieimpact.org/index.php?r=search/detailView&id=320.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/16697.",2020,"METHODS


Married women aged 18-35 years who were either pregnant or had recently given birth were randomly assigned to either the intervention arm or control arm.","['urban Malawi', 'A total of 2143 women', 'A total of 1773 women, or 82.73% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the first follow-up', 'A total of 1669 women, or 77.88% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the second follow-up', 'first follow-up survey began in August 2017 and was completed in February 2018', 'Postpartum Women', 'Married women aged 18-35 years who were either pregnant or had recently given birth']","['brochure and up to 6 home visits from trained family planning counselors; free transportation to a high-quality family planning clinic; and financial reimbursement for family planning services, consultations, and referrals for services', 'package of services over a 2-year intervention period']",['fertility and health outcomes'],"[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040756', 'cui_str': 'Transportation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3840184', 'cui_str': 'Family planning clinic'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0584065', 'cui_str': 'Referral to service'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",2143.0,0.179633,"METHODS


Married women aged 18-35 years who were either pregnant or had recently given birth were randomly assigned to either the intervention arm or control arm.","[{'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Karra', 'Affiliation': 'Frederick S Pardee School of Global Studies, Boston University, Boston, MA, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Canning', 'Affiliation': 'Department of Global Health and Population, Harvard T H Chan School of Public Health, Harvard University, Boston, MA, United States.'}]",JMIR research protocols,['10.2196/16697']
2153,32796329,Modified Buried Vertical Mattress Suture Versus Buried Intradermal Suture: A Prospective Split-Scar Study.,"BACKGROUND


The modified buried vertical mattress suture (MBVMS) is believed to provide excellent outcomes by relieving the tension on wound edges. However, clinical data on the topic remain sparse and inadequate.
OBJECTIVE


To compare the cosmetic results of the MBVMS and the buried intradermal suture (BIS) in chest wounds using a split-scar model.
MATERIALS AND METHODS


Twenty patients participated in the study. One randomly selected half of each chest wound was closed with the MBVMS; the other half was closed with the BIS. Immediately, postoperatively, the maximum degree of wound eversion was obtained. After 3 months, the wound complication rates were recorded, and the aesthetic appearance of each scar was evaluated by the Patient and Observer Scar Assessment Scale (POSAS), the Vancouver Scar Scale (VSS), the visual analog scale (VAS), and scar width.
RESULTS


The MBVMS yielded a greater mean postoperative eversion height and width (p < .05); lower POSAS, VSS, and VAS scores (p < .05); and a narrower scar width (p < .05) than did the BIS.
CONCLUSION


Compared with the BIS, the MBVMS provided significantly increased wound eversion immediately, postoperatively, and improved aesthetic outcomes at the end of the 3-month follow-up period.",2020,"Compared with the BIS, the MBVMS provided significantly increased wound eversion immediately, postoperatively, and improved aesthetic outcomes at the end of the 3-month follow-up period.",['Twenty patients participated in the study'],"['modified buried vertical mattress suture (MBVMS', 'Modified Buried Vertical Mattress Suture Versus Buried Intradermal Suture', 'MBVMS and the buried intradermal suture (BIS']","['POSAS, VSS, and VAS scores', 'aesthetic appearance of each scar', 'wound complication rates', 'wound eversion', 'Patient and Observer Scar Assessment Scale (POSAS), the Vancouver Scar Scale (VSS), the visual analog scale (VAS), and scar width', 'aesthetic outcomes', 'narrower scar width', 'mean postoperative eversion height and width', 'maximum degree of wound eversion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0263398', 'cui_str': 'Erythema elevatum diutinum'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0024940', 'cui_str': 'Mattress'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0015211', 'cui_str': 'Eversion'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",1.0,0.0127069,"Compared with the BIS, the MBVMS provided significantly increased wound eversion immediately, postoperatively, and improved aesthetic outcomes at the end of the 3-month follow-up period.","[{'ForeName': 'Zonghui', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Zhishui', 'Initials': 'Z', 'LastName': 'Tang', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Hao', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Xueyuan', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Youcheng', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}, {'ForeName': 'Maoguo', 'Initials': 'M', 'LastName': 'Shu', 'Affiliation': ""Department of Aesthetic, Plastic and Maxillofacial Surgery, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.""}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002642']
2154,32798197,"Effects of the pestle needle therapy, a type of acupoint stimulation, on post-hemorrhoidectomy pain: A randomized controlled trial.","BACKGROUND


Hemorrhoids are one of the most common conditions that lead to surgery, and until now surgical hemorrhoidectomy has been the major effective treatment. Post-operative pain from hemorrhoidectomy has been experienced by thousands of patients and remains a major inconvenience of the operation.
OBJECTIVE


This study evaluates the clinical efficacy of the pestle needle therapy, an acupoint stimulation method, for relief of post-hemorrhoidectomy pain.
DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS


This was a single-center, patient-assessor-blinded and randomized controlled trial with 154 patients receiving Milligan hemorrhoidectomy surgery. Eligible patients were randomly assigned to either a treatment group or a control group at a ratio of 1:1. The treatment group received the pestle needle therapy, with manual stimulation at Yaoshu (DU2), Mingmen (DU4), Changqiang (DU1), Chengshan (BL57), Erbai (EX-UE2) and the perianal points (1, 3, 5, 7, 9, and 11o'clock around the lesion); while the control group received a sham treatment with very light pressure. Three sessions of treatment were performed at 30 min, 4 h and 12 h after the surgery, and each lasted for 15 min.
MAIN OUTCOME MEASURES


The primary outcome was post-operative pain measured with the visual analogue scale (VAS) at 12 h after surgery. The secondary outcomes included the VAS scores measured at 0.5, 2, 4, 6, 8, 24 and 48 h after surgery, the analgesic dose, the time and the VAS score of the patients' first defecation after surgery, as well as the Hamilton Rating Scale for Anxiety (HAMA) evaluated before discharge.
RESULTS


The mean pain score of the treatment group was significantly lower than that of the control group (3.10 ± 1.27 vs 4.82 ± 1.29; P < 0.001) at 12 h after surgery. Compared with the control group, patients in the treatment group needed a smaller dose of analgesic within the first 24 hours after surgery (P = 0.002); and their HAMA scores before discharge were lower (4.07 ± 2.40 vs 5.10 ± 2.45, P = 0.009). Compared to the treatment group, patients in the control group had a greater time to the first defecation after surgery ([52.34 ± 15.72] h vs [27.08 ± 13.68] h; P < 0.001), but there was no difference in their VAS scores at the first defecation (P = 0.092).
CONCLUSION


The pestle needle therapy was effective for relieving pain, reducing anxiety and improving bowel function after hemorrhoidectomy, and it is worthy of clinical application.",2020,"The pestle needle therapy was effective for relieving pain, reducing anxiety and improving bowel function after hemorrhoidectomy, and it is worthy of clinical application.","['post-hemorrhoidectomy pain', '154 patients receiving', 'Eligible patients']","['pestle needle therapy', 'pestle needle therapy, with manual stimulation at Yaoshu (DU2), Mingmen (DU4), Changqiang (DU1), Chengshan (BL57), Erbai (EX-UE2', 'sham treatment with very light pressure', 'Milligan hemorrhoidectomy surgery']","['HAMA scores before discharge', 'greater time to the first defecation', ""analgesic dose, the time and the VAS score of the patients' first defecation"", 'post-operative pain measured with the visual analogue scale (VAS', 'mean pain score', 'Hamilton Rating Scale for Anxiety (HAMA', 'relieving pain, reducing anxiety and improving bowel function', 'VAS scores']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439538', 'cui_str': 'Very light'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0019108', 'cui_str': 'Hemorrhoidectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",154.0,0.0722755,"The pestle needle therapy was effective for relieving pain, reducing anxiety and improving bowel function after hemorrhoidectomy, and it is worthy of clinical application.","[{'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China.'}, {'ForeName': 'Xiu-Tian', 'Initials': 'XT', 'LastName': 'Guo', 'Affiliation': 'Department of Proctology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China.'}, {'ForeName': 'Wen-Qi', 'Initials': 'WQ', 'LastName': 'Jin', 'Affiliation': 'Department of Proctology, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China.'}, {'ForeName': 'Ai-Jun', 'Initials': 'AJ', 'LastName': 'Mao', 'Affiliation': 'Department of Nursing, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China.'}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Lao', 'Affiliation': 'School of Chinese Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China; Virginia University of Integrative Medicine, Fairfax, VA 22031, USA.'}, {'ForeName': 'Zhang-Jin', 'Initials': 'ZJ', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Nursing, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China. Electronic address: chengyong2002@126.com.'}, {'ForeName': 'Shi-Fen', 'Initials': 'SF', 'LastName': 'Xu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai 200071, China. Electronic address: xu_teacher2006@126.com.'}]",Journal of integrative medicine,['10.1016/j.joim.2020.08.001']
2155,32798224,One-year decline of poliovirus antibodies following fractional-dose inactivated poliovirus vaccine.,"BACKGROUND


Fractional dose (1/5th of full intramuscular dose) of inactivated poliovirus-vaccine administered intradermally (fIPV) is used as IPV dose-sparing strategy. We compared the rate of decline of poliovirus antibodies (PVA) in recipients of either two doses of fIPV or IPV.
METHODS


Community-based randomized controlled trial was conducted in Karachi, Pakistan. Children aged 14 weeks were randomized into fIPV or full IPV study arms (A, B) and received one vaccine doses at 14 weeks and one at 9 months of age. PVA were measured at 14, 18 weeks and 10, 21 months of age.
RESULTS


Seroprevalence of poliovirus-type 2 antibodies of 170/250 (68%) enrolled children after two IPV or fIPV doses at 10 months of age in arms-A and B reached 100% vs 99% (p=0.339); and at 21 months it was 86% vs 67% (p=0.004). Between 10 and 21 months of age, the antibody-titers in log2 scale dropped from >=10.5 to 6.8 in arm-A; and from 9.2 to 3.7 in arm B.
INTERPRETATION


A significant decline in antibody titers12 months following second IPV dose. The slope of decline is similar for both full IPV and fIPV recipients. The results provide further evidence that fIPV is a viable option for IPV dose-sparing.",2020,"Between 10 and 21 months of age, the antibody-titers in log2 scale dropped from >=10.5 to 6.8 in arm-A; and from 9.2 to 3.7 in arm B.
INTERPRETATION


A significant decline in antibody titers12 months following second IPV dose.","['Community-based randomized controlled trial was conducted in Karachi, Pakistan', 'recipients of either two doses of fIPV or IPV', 'Children aged 14 weeks']","['inactivated poliovirus-vaccine administered intradermally (fIPV', 'fractional-dose inactivated poliovirus vaccine']","['antibody-titers in log2 scale', 'poliovirus antibodies', 'PVA', 'rate of decline of poliovirus antibodies (PVA']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0085305', 'cui_str': 'Feline infectious peritonitis virus'}, {'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0036106', 'cui_str': 'Salk Vaccine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0085305', 'cui_str': 'Feline infectious peritonitis virus'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0206435', 'cui_str': 'Human poliovirus'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]",,0.169346,"Between 10 and 21 months of age, the antibody-titers in log2 scale dropped from >=10.5 to 6.8 in arm-A; and from 9.2 to 3.7 in arm B.
INTERPRETATION


A significant decline in antibody titers12 months following second IPV dose.","[{'ForeName': 'Ali Faisal', 'Initials': 'AF', 'LastName': 'Saleem', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Mach', 'Affiliation': 'Polio Eradication Department, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Mohammad Tahir', 'Initials': 'MT', 'LastName': 'Yousafzai', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Zaubina', 'Initials': 'Z', 'LastName': 'Kazi', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Attaullah', 'Initials': 'A', 'LastName': 'Baig', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Sajid', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}, {'ForeName': 'Vishali', 'Initials': 'V', 'LastName': 'Jeyaseelan', 'Affiliation': 'Polio Eradication Department, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Roland W', 'Initials': 'RW', 'LastName': 'Sutter', 'Affiliation': 'Polio Eradication Department, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Anita K M', 'Initials': 'AKM', 'LastName': 'Zaidi', 'Affiliation': 'Aga Khan University, Karachi, Pakistan.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa504']
2156,32798261,"The effect of saffron supplementation on some inflammatory and oxidative markers, leptin, adiponectin, and body composition in patients with nonalcoholic fatty liver disease: A double-blind randomized clinical trial.","BACKGROUND


Nonalcoholic fatty liver disease (NAFLD) is characterized by oxidative stress and inflammation in the hepatocytes. Saffron and its constituents are reported to have several properties such as anti-inflammatory and anti-diabetic effects.
MATERIALS AND METHODS


In a randomized double-blind placebo-controlled trial with two parallel groups including 76 eligible men and female patients with NAFLD aged 18-65, recruited from Hazrat Rasul Akram Hospital in Tehran, Iran. NAFLD was defined by a Gastroenterologist based on the American Gastrointestinal and Liver Association standards. Participants were randomly assigned to two groups receiving daily supplementation of either one tablet of 100 mg saffron (n = 38) or one placebo (n = 38) for 12 weeks. The primary outcome was high sensitive C-reactive protein (hs-CRP) and secondary outcomes were alanine aminotransferase (ALT), aspartate aminotransferase (AST), tumor necrosis factor alpha (TNF-α), malondialdehyde (MDA), total anti-oxidant capacity (TAC), leptin, adiponectin, anthropometric, and body composition Both groups were assigned similar diet and physical activity.
RESULTS


In the treatment group, significant decreases in hs-CRP (-1.80 ng/ml, 95% CI = -2.97, -0.63, p = .032), leptin (-0.27 ng/ml, 95% CI = -0.65, -0.10, p = .040), MDA (-1.01 ng/ml, 95% CI = -1.89, -0.14, p = .023) and significant increase in TAC (0.34 μmol/L, 95% CI = 0.08, 0.61, p = .011) were observed compared to the placebo group. However, there were no significant changes in serum alanine aminotransferase, AST, TNF-α, body composition, and anthropometric indexes (p > .05).
CONCLUSION


In the present study, 12 weeks of 100 mg of saffron supplementation indicated beneficial effects on serum levels of some inflammatory, oxidative stress, and adipokines biomarkers but it had no significant effect on serum concentrations of liver enzymes, anthropometric, and body composition measurements.",2020,"In the treatment group, significant decreases in hs-CRP (-1.80 ng/ml, 95% CI = -2.97, -0.63, p = .032), leptin (-0.27 ng/ml, 95% CI = -0.65,","['patients with nonalcoholic fatty liver disease', '76 eligible men and female patients with NAFLD aged 18-65, recruited from Hazrat Rasul Akram Hospital in Tehran, Iran']","['saffron supplementation', 'daily supplementation of either one tablet of 100\u2009mg saffron', 'placebo']","['serum alanine aminotransferase, AST, TNF-α, body composition, and anthropometric indexes', 'serum concentrations of liver enzymes, anthropometric, and body composition measurements', 'inflammatory and oxidative markers, leptin, adiponectin, and body composition', 'leptin', 'high sensitive C-reactive protein (hs-CRP) and secondary outcomes were alanine aminotransferase (ALT), aspartate aminotransferase (AST), tumor necrosis factor alpha (TNF-α), malondialdehyde (MDA), total anti-oxidant capacity (TAC), leptin, adiponectin, anthropometric, and body composition', 'MDA', 'TAC', 'serum levels of some inflammatory, oxidative stress, and adipokines biomarkers', 'hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0162753', 'cui_str': 'Saffron Stain'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}]",,0.674433,"In the treatment group, significant decreases in hs-CRP (-1.80 ng/ml, 95% CI = -2.97, -0.63, p = .032), leptin (-0.27 ng/ml, 95% CI = -0.65,","[{'ForeName': 'Farnaz Kaviani', 'Initials': 'FK', 'LastName': 'Pour', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Naheed', 'Initials': 'N', 'LastName': 'Aryaeian', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mokhtare', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reyhane Sadat', 'Initials': 'RS', 'LastName': 'Mirnasrollahi Parsa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Jannani', 'Affiliation': 'Department of Biostatistics, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Agah', 'Affiliation': 'Colorectal Research Center, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sodabeh', 'Initials': 'S', 'LastName': 'Fallah', 'Affiliation': 'Department of Clinical Biochemistry, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nariman', 'Initials': 'N', 'LastName': 'Moradi', 'Affiliation': 'Department of Clinical Biochemistry, Faculty of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6791']
2157,32798283,Nuclease Therapy Improves Severe Fatigue in Primary Sjögren's Syndrome: A Randomized Clinical Trial.,"OBJECTIVE


To assess the safety and efficacy of RSLV-132, an RNase Fc fusion protein in a phase II randomized, double-blind, placebo-controlled clinical trial in patients with primary Sjögren's syndrome (pSS).
METHODS


Thirty patients were randomized to receive intravenous RSLV-132 or placebo, weekly for two weeks then every two weeks for twelve weeks. Eight subjects received placebo and twenty received RSLV-132, 10 mg/kg. Clinical efficacy measures included the European League Against Rheumatism (EULAR) Sjögren's syndrome disease activity index (ESSDAI), EULAR Sjögren's syndrome patient reported index (ESSPRI), FACIT fatigue (FACIT-F), and profile of fatigue (ProF), and the digit symbol substitution test (DSST).
RESULTS


Patients randomized to RSLV-132, but not placebo, experienced clinically meaningful improvements in ESSPRI, FACIT-F, ProF, and DSST. This improvement was correlated with increased expression of selected interferon-inducible genes.
CONCLUSION


Administration of RSLV-132 improved severe fatigue in pSS patients as determined by four independent measures of fatigue.",2020,"RESULTS


Patients randomized to RSLV-132, but not placebo, experienced clinically meaningful improvements in ESSPRI, FACIT-F, ProF, and DSST.","[""Primary Sjögren's Syndrome"", ""patients with primary Sjögren's syndrome (pSS"", 'Thirty patients']","['Nuclease Therapy', 'RSLV-132', 'intravenous RSLV-132 or placebo', 'placebo']","['ESSPRI, FACIT-F, ProF, and DSST', 'expression of selected interferon-inducible genes', 'severe fatigue', ""Sjögren's syndrome disease activity index (ESSDAI), EULAR Sjögren's syndrome patient reported index (ESSPRI), FACIT fatigue (FACIT-F), and profile of fatigue (ProF), and the digit symbol substitution test (DSST"", 'Severe Fatigue', 'European League Against Rheumatism (EULAR']","[{'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0597094', 'cui_str': 'Nuclease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4705323', 'cui_str': 'RSLV-132'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1527336', 'cui_str': ""Sjögren's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}]",30.0,0.53509,"RESULTS


Patients randomized to RSLV-132, but not placebo, experienced clinically meaningful improvements in ESSPRI, FACIT-F, ProF, and DSST.","[{'ForeName': 'James', 'Initials': 'J', 'LastName': 'Posada', 'Affiliation': 'Resolve Therapeutics, St. Petersburg, FL.'}, {'ForeName': 'Saba', 'Initials': 'S', 'LastName': 'Valadkhan', 'Affiliation': 'Case Western Reserve University, Cleveland, OH, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Burge', 'Affiliation': 'Resolve Therapeutics, St. Petersburg, FL.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Davies', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Tarn', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Casement', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Jobling', 'Affiliation': 'Newcastle Biomedical Research Centre and Newcastle upon Tyne Hospital NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gallagher', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'Q2 Solutions, Morrisville, NC.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Barone', 'Affiliation': 'Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Benjamin A', 'Initials': 'BA', 'LastName': 'Fisher', 'Affiliation': 'Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Wan-Fai', 'Initials': 'WF', 'LastName': 'Ng', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, UK.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41489']
2158,32803438,"Fissure caries inhibition with a CO 2  9.3-μm short-pulsed laser-a randomized, single-blind, split-mouth controlled, 1-year clinical trial.","OBJECTIVES


The objective of this randomized, single-blind, split-mouth controlled, clinical trial was to evaluate whether the use of a short-pulsed 9.3-μm CO 2  laser increases the caries resistance of occlusal pit and fissures in addition to fluoride therapy over 12 months.
MATERIALS AND METHODS


A total of 60 participants, average age 13.1 years, were enrolled. At baseline, second molars were randomized into test and control, and assessed by ICDAS, SOPROLIFE, and DIAGNOdent. An independent investigator irradiated test molars with a CO 2  laser (wavelength 9.3 μm, pulse duration 4 μs, pulse repetition rate 43 Hz, beam diameter 250 μm, average fluence 3.9 J/cm 2 , 20 laser pulses per spot). Test molars received laser and fluoride treatment, control teeth fluoride alone. Fluoride varnish was applied at baseline and at 6 months. After 6 and 12 months, teeth were again assessed.
RESULTS


A total of 57 participants completed the 6-month and 51 the 12-month recall. Laser-treated surfaces showed very slight ICDAS improvements over time with ICDAS change - 1 in 11% and 8%, no changes (ICDAS change 0) in 68% and 67%, and slightly worsened (ICDAS change 1) in 19% and 24% at 6- and 12-month recalls, respectively, and worsened by two scores in 2% at both recall time points. Control teeth showed significantly higher ICDAS increases, with 47% and 25% showing ICDAS change 0, ICDAS change 1 in 49% and 55%, and ICDAS change 2 in 4% and 20% at 6- and 12-month recalls, respectively. Differences in ICDAS changes between the groups were statistically significant (P = 0.0002 and P < 0.0001; Wilcoxon's signed-rank test, exact). A total of 22% of the participants developed ICDAS 3 scores on the control teeth.
CONCLUSIONS


Microsecond short-pulsed 9.3-μm CO 2  laser irradiation markedly inhibits caries progression in pits and fissures in comparison with fluoride varnish alone.
CLINICAL RELEVANCE


The 9.3-μm CO 2  laser irradiation of pits and fissures enhances caries resistance.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02357979.",2020,"CONCLUSIONS


Microsecond short-pulsed 9.3-μm CO 2  laser irradiation markedly inhibits caries progression in pits and fissures in comparison with fluoride varnish alone.
","['57 participants completed the 6-month and 51 the 12-month recall', 'The 9.3-μm CO 2  laser irradiation of pits and', 'A total of 60 participants, average age 13.1\xa0years, were enrolled']","['laser and fluoride treatment, control teeth fluoride alone', 'Fluoride varnish']","['caries resistance of occlusal pit and fissures', 'ICDAS', 'ICDAS changes', 'ICDAS 3 scores', 'ICDAS change 0, ICDAS change', 'ICDAS change']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0175697', 'cui_str': 'Van der Woude syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0016326', 'cui_str': 'Fluoride Varnishes'}]","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0447303', 'cui_str': 'Structure of occlusal surface of tooth'}, {'cui': 'C0175697', 'cui_str': 'Van der Woude syndrome'}, {'cui': 'C0332469', 'cui_str': 'Fissure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",57.0,0.144401,"CONCLUSIONS


Microsecond short-pulsed 9.3-μm CO 2  laser irradiation markedly inhibits caries progression in pits and fissures in comparison with fluoride varnish alone.
","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rechmann', 'Affiliation': 'Department of Preventive and Restorative Dental Sciences, School of Dentistry, University of California at San Francisco, 707 Parnassus, San Francisco, CA, 94143, USA. Peter.Rechmann@ucsf.edu.'}, {'ForeName': 'Maxwell', 'Initials': 'M', 'LastName': 'Kubitz', 'Affiliation': 'Division of Pediatric Dentistry, Department of Orofacial Sciences, School of Dentistry, University of California at San Francisco, 707 Parnassus, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Benjamin W', 'Initials': 'BW', 'LastName': 'Chaffee', 'Affiliation': 'Department of Preventive and Restorative Dental Sciences, School of Dentistry, University of California at San Francisco, 707 Parnassus, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Beate M T', 'Initials': 'BMT', 'LastName': 'Rechmann', 'Affiliation': 'Department of Preventive and Restorative Dental Sciences, School of Dentistry, University of California at San Francisco, 707 Parnassus, San Francisco, CA, 94143, USA.'}]",Clinical oral investigations,['10.1007/s00784-020-03515-x']
2159,32803439,"Comparison of the effect of therapeutic elastic bandage, submucosal dexamethasone, or dexketoprofen trometamol on inflammatory symptoms and quality of life following third molar surgery: a randomized clinical trial.","OBJECTIVES


We aimed to compare the effects of preoperative single-dose submucosal corticosteroid injection and postoperative elastic therapeutic bandage application with postoperative non-steroid anti-inflammatory drug therapy on postoperative inflammatory symptoms and quality of life following mandibular third molar surgeries.
MATERIALS AND METHODS


A single-center, randomized, clinical trial was conducted with 52 patients (36 female, 16 male) who expected severe postoperative sequelae as a result of the extraction of impacted mandibular third molars. The patients were randomized into three groups. In the preoperative submucosal corticosteroid injection group (n = 16), 8 mg/2 ml dexamethasone 21-phosphate was administered near operated sites. In the postoperative therapeutic elastic bandage application group (n = 19), Kinesio tapes were applied to operated sites. Paracetamol 500 mg was prescribed for the patients in the corticosteroid and elastic bandage application groups. In the postoperative non-steroid anti-inflammatory drug group (n = 17), 25 mg dexketoprofen trometamol was prescribed. Maximal mouth opening, swelling, pain, and Oral Health Impaction Profile scores were quantified preoperatively and postoperatively on the second and seventh days. Additionally, all patients were asked to evaluate the postoperative period by the Postoperative Symptom Severity Scale.
RESULTS


Analysis of the obtained data revealed that on the second postoperative day, postoperative edema and trismus were significantly lower in the submucosal corticosteroid (p = 0.025, p = 0.03) and therapeutic elastic bandage (p = 0.032, p = 0.014) groups, and the patients in these groups had a more comfortable postoperative period than the group prescribed a postoperative non-steroid anti-inflammatory drug (p = 0.016).
CLINICAL RELEVANCE


In oral surgery, postoperative elastic bandage application can provide results similar to those of preoperative submucosal corticosteroid injection with respect to inflammatory symptoms and quality of life.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT04200885. Date of Registration: December 2019 (retrospectively registered).",2020,"In oral surgery, postoperative elastic bandage application can provide results similar to those of preoperative submucosal corticosteroid injection with respect to inflammatory symptoms and quality of life.
","['following third molar surgery', 'mandibular third molar surgeries', '52 patients (36 female, 16 male) who expected severe postoperative sequelae as a result of the extraction of impacted mandibular third molars']","['preoperative single-dose submucosal corticosteroid injection and postoperative elastic therapeutic bandage application with postoperative non-steroid anti-inflammatory drug therapy', 'dexamethasone 21-phosphate', 'dexketoprofen trometamol', 'Paracetamol', 'therapeutic elastic bandage, submucosal dexamethasone, or dexketoprofen trometamol', 'Kinesio tapes']","['postoperative inflammatory symptoms and quality of life', 'inflammatory symptoms and quality of life', 'Maximal mouth opening, swelling, pain, and Oral Health Impaction Profile scores', 'therapeutic elastic bandage', 'Postoperative Symptom Severity Scale', 'postoperative edema and trismus']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0243088', 'cui_str': 'sequels'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1515025', 'cui_str': 'Submucosal route'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0004726', 'cui_str': 'Bandage'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0770565', 'cui_str': 'Dexamethasone phosphate'}, {'cui': 'C0765538', 'cui_str': 'Dexketoprofen tromethamine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0336591', 'cui_str': 'Elastic bandage'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0336591', 'cui_str': 'Elastic bandage'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}]",,0.0658578,"In oral surgery, postoperative elastic bandage application can provide results similar to those of preoperative submucosal corticosteroid injection with respect to inflammatory symptoms and quality of life.
","[{'ForeName': 'Aras', 'Initials': 'A', 'LastName': 'Erdil', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tokat Gaziosmanpasa University, Kaleardi Mahallesi, Muhittin Fisunoglu Caddesi, Omcalik Sokak, Ali Sevki Erek Yerleskesi, Dis Hekimligi Fakultesi, Tokat, Turkey. erdil.aras@gmail.com.'}, {'ForeName': 'Nihat', 'Initials': 'N', 'LastName': 'Akbulut', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tokat Gaziosmanpasa University, Kaleardi Mahallesi, Muhittin Fisunoglu Caddesi, Omcalik Sokak, Ali Sevki Erek Yerleskesi, Dis Hekimligi Fakultesi, Tokat, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Altan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tokat Gaziosmanpasa University, Kaleardi Mahallesi, Muhittin Fisunoglu Caddesi, Omcalik Sokak, Ali Sevki Erek Yerleskesi, Dis Hekimligi Fakultesi, Tokat, Turkey.'}, {'ForeName': 'Mustafa Sami', 'Initials': 'MS', 'LastName': 'Demirsoy', 'Affiliation': 'Private Practice, Arabacialani Mahallesi, Mert Sokak, No: 25, Sakarya, Turkey.'}]",Clinical oral investigations,['10.1007/s00784-020-03487-y']
2160,32803473,"Reliability, Validity and Responsiveness of the EQ-5D-5L in Assessing and Valuing Health Status in Adolescents and Young Adults with Posttraumatic Stress Disorder: a Randomized Controlled Trail.","To validate the EQ-5D-5L health-related quality of life (HrQoL) questionnaire in adolescents and young adults with posttraumatic stress disorder (PTSD) after sexual and/or physical abuse. We used data from a randomized controlled trial of 87 participants with PTSD aged 14-21 years. The discriminative ability was evaluated by comparing participants scores on the descriptive system of the EQ-5D-5L with general population scores. Furthermore, the discriminative ability between subgroups of participants with different disease severity levels was estimated. Correlations between the EQ-5D index and clinical parameters were used to measure construct validity. Test-retest reliability was measured by intraclass correlation coefficients (ICC) between baseline, posttreatment and 3-month follow-up scores of participants with stable symptoms. Finally, the responsiveness of the EQ-5D was calculated by mean differences, effect sizes and receiver operating characteristic (ROC) analyses for participants with improved symptoms. Participants reported significantly more problems on the dimensions ""mobility"", ""usual activities"", ""pain/discomfort"" and ""anxiety/depression"" than the general population. The EQ-5D-5L was able to discriminate between different disease severity levels. The EQ-5D index and clinical scales were significantly correlated with absolute values of correlation coefficients varying between 0.21 and 0.59. Furthermore, ICCs between 0.65 and 0.91 indicated good test-retest reliability for the EQ-5D index. The ICCs for the EQ-VAS between baseline and 3-month follow-up, and posttreatment and 3-month follow-up were statistically significant with 0.71 and 0.87, respectively, whereas the ICC between baseline and posttreatment was 0.08 and not statistically significant. Effect sizes to measure the responsiveness ranged between -0.008 and 0.40 for the EQ-5D index and - 0.32 and 0.40 for the EQ-VAS. Furthermore, the area under the curve in ROC analyses was between 0.40 and 0.64 for the EQ-5D index and 0.60 and 0.70 for the EQ-VAS. Discriminative ability, test-retest reliability and construct validity of the EQ-5D-5L were good, whereas the responsiveness was rather weak. Nevertheless, the EQ-5D-5L can be used to measure HrQoL in adolescents and young adults with PTSD. German Clinical Trials Register identifier: DRKS00004787; date of registration: 18th March 2013; https://www.drks.de.",2020,Effect sizes to measure the responsiveness ranged between -0.008 and 0.40 for the EQ-5D index and - 0.32 and 0.40 for the EQ-VAS.,"['adolescents and young adults with PTSD', 'adolescents and young adults with posttraumatic stress disorder (PTSD) after sexual and/or physical abuse', '87 participants with PTSD aged 14-21\xa0years', 'Adolescents and Young Adults with Posttraumatic Stress Disorder']",['EQ-5D-5L'],"['effect sizes and receiver operating characteristic (ROC) analyses', 'Test-retest reliability', 'EQ-5D index and clinical scales', 'EQ-5D-5L health-related quality of life (HrQoL) questionnaire', 'Reliability, Validity and Responsiveness of the EQ-5D-5L in Assessing and Valuing Health Status', 'dimensions ""mobility"", ""usual activities"", ""pain/discomfort"" and ""anxiety/depression', 'Discriminative ability, test-retest reliability and construct validity', 'discriminative ability']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C1621955', 'cui_str': 'Physical abuse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0012931', 'cui_str': 'Recombinant DNA'}]",87.0,0.0473357,Effect sizes to measure the responsiveness ranged between -0.008 and 0.40 for the EQ-5D index and - 0.32 and 0.40 for the EQ-VAS.,"[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Dams', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics (HCHE), University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany. j.dams@uke.de.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Rimane', 'Affiliation': 'Department of Psychology, Catholic University Eichstätt-Ingolstadt, Eichstätt, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Steil', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Institute of Psychology, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Babette', 'Initials': 'B', 'LastName': 'Renneberg', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Freie Universitaet Berlin, Berlin, Germany.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Rosner', 'Affiliation': 'Department of Psychology, Catholic University Eichstätt-Ingolstadt, Eichstätt, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, Hamburg Center for Health Economics (HCHE), University Medical Center Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.'}]",The Psychiatric quarterly,['10.1007/s11126-020-09814-6']
2161,32803636,Influence of green tea consumption on endoxifen steady-state concentration in breast cancer patients treated with tamoxifen.,"BACKGROUND


Many cancer patients use additional herbs or supplements in combination with their anti-cancer therapy. Green tea-active ingredient epigallocatechin-3-gallate (EGCG)-is one of the most commonly used dietary supplements among breast cancer patients. EGCG may alter the metabolism of tamoxifen. Therefore, the aim of this study was to investigate the influence of green tea supplements on the pharmacokinetics of endoxifen; the most relevant active metabolite of tamoxifen.
METHODS


In this single-center, randomized cross-over trial, effects of green tea capsules on endoxifen levels were evaluated. Patients treated with tamoxifen for at least 3 months were eligible for this study. After inclusion, patients were consecutively treated with tamoxifen monotherapy for 28 days and in combination with green tea supplements (1 g twice daily; containing 300 mg EGCG) for 14 days (or vice versa). Blood samples were collected on the last day of monotherapy or combination therapy. Area under the curve (AUC 0-24h ), maximum concentration (C max ) and minimum concentration (C trough ) were obtained from individual plasma concentration-time curves.
RESULTS


No difference was found in geometric mean endoxifen AUC 0-24h  in the period with green tea versus tamoxifen monotherapy (- 0.4%; 95% CI - 8.6 to 8.5%; p = 0.92). Furthermore, no differences in C max  (- 2.8%; - 10.6 to 5.6%; p = 0.47) nor C trough  (1.2%; - 7.3 to 10.5%; p = 0.77) were found. Moreover, no severe toxicity was reported during the whole study period.
CONCLUSIONS


This study demonstrated the absence of a pharmacokinetic interaction between green tea supplements and tamoxifen. Therefore, the use of green tea by patients with tamoxifen does not have to be discouraged.",2020,No difference was found in geometric mean endoxifen AUC 0-24h  in the period with green tea versus tamoxifen monotherapy (- 0.4%; 95% CI - 8.6 to 8.5%; p = 0.92).,"['breast cancer patients treated with', 'breast cancer patients']","['tamoxifen monotherapy', 'EGCG', 'green tea consumption', 'additional herbs or supplements in combination with their anti-cancer therapy', 'green tea capsules', 'green tea supplements (1\xa0g twice daily; containing 300\xa0mg EGCG', 'green tea supplements', 'Green tea-active ingredient epigallocatechin-3-gallate (EGCG)-is', 'tamoxifen']","['metabolism of tamoxifen', 'Area under the curve (AUC 0-24h ), maximum concentration (C max ) and minimum concentration (C trough ', 'severe toxicity', 'endoxifen steady-state concentration', 'C max', 'geometric mean endoxifen AUC', 'endoxifen levels']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1292749', 'cui_str': 'Has active ingredient'}]","[{'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0048311', 'cui_str': '4-hydroxy-N-desmethyltamoxifen'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.137654,No difference was found in geometric mean endoxifen AUC 0-24h  in the period with green tea versus tamoxifen monotherapy (- 0.4%; 95% CI - 8.6 to 8.5%; p = 0.92).,"[{'ForeName': 'C Louwrens', 'Initials': 'CL', 'LastName': 'Braal', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands. c.braal@erasmusmc.nl.'}, {'ForeName': 'Koen G A M', 'Initials': 'KGAM', 'LastName': 'Hussaarts', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Lieke', 'Initials': 'L', 'LastName': 'Seuren', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Oomen-de Hoop', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'de Bruijn', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Stefan A J', 'Initials': 'SAJ', 'LastName': 'Buck', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Monique E M M', 'Initials': 'MEMM', 'LastName': 'Bos', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Martine F', 'Initials': 'MF', 'LastName': 'Thijs-Visser', 'Affiliation': 'Department of Medical Oncology, Ikazia Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Hanneke J M', 'Initials': 'HJM', 'LastName': 'Zuetenhorst', 'Affiliation': 'Department of Internal Medicine, Franciscus Gasthuis & Vlietland, Schiedam, The Netherlands.'}, {'ForeName': 'Daniëlle', 'Initials': 'D', 'LastName': 'Mathijssen-van Stein', 'Affiliation': 'Department of Internal Medicine, Franciscus Gasthuis & Vlietland, Schiedam, The Netherlands.'}, {'ForeName': 'Mijntje B', 'Initials': 'MB', 'LastName': 'Vastbinder', 'Affiliation': 'Department of Internal Medicine, IJsselland Hospital, Capelle aan den IJssel, The Netherlands.'}, {'ForeName': 'Roelof W F', 'Initials': 'RWF', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Teun', 'Initials': 'T', 'LastName': 'van Gelder', 'Affiliation': 'Department of Clinical Pharmacy and Toxicology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Stijn L W', 'Initials': 'SLW', 'LastName': 'Koolen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Jager', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}, {'ForeName': 'Ron H J', 'Initials': 'RHJ', 'LastName': 'Mathijssen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Dr. Molewaterplein 40, CN, PO Box 2040, 3015, Rotterdam, The Netherlands.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05829-6']
2162,32800303,Sudden Gains in Internet-Based Cognitive Behavior Therapy for Body Dysmorphic Disorder.,"Sudden gains have been associated with better short- and long-term treatment outcomes in a number of psychiatric disorders. However, no studies to date have evaluated sudden gains in body dysmorphic disorder (BDD). We used data from a previous randomized controlled trial evaluating the efficacy of an Internet-based cognitive-behavior treatment (CBT) for BDD. The sample consisted of 47 adults diagnosed with BDD. We compared the treatment outcomes of sudden gainers vs. gradual gainers (i.e., treatment responders with no sudden gains) and non-sudden gainers (i.e., gradual gainers plus nonresponders) at posttreatment and 3, 12, and 24 months after the end of the treatment. Twelve (25.5%) participants experienced a sudden gain. Compared to non-sudden gainers and to gradual gainers, sudden gainers showed significantly larger improvements on the Yale-Brown Obsessive-Compulsive Scale modified for BDD at posttreatment (g = 1.23 and g = .91, respectively), and at 3-month (g = 1.23 and g = 1.00, respectively), 12-month (g = 1.12 and g = .91, respectively), and 24-month follow-up (g = 1.11 and g = .97, respectively). This translated into higher rates of treatment responders and remitters in the sudden gainers across all time points. The occurrence of sudden gains in Internet-based CBT for BDD is associated with favorable short- and long-term treatment outcomes. This suggests that a sudden improvement during the treatment could be a marker of good prognosis, while non-sudden-including gradual-gainers are more likely to need continued support or booster sessions. Early identification of patients who are not progressing as expected and subsequent tailoring of the delivered intervention has the potential to improve treatment outcomes in this group.",2020,"Compared to non-sudden gainers and to gradual gainers, sudden gainers showed significantly larger improvements on the Yale-Brown Obsessive-Compulsive Scale modified for BDD at posttreatment (g = 1.23 and g = .91, respectively), and at 3-month (g = 1.23 and g = 1.00, respectively), 12-month (g = 1.12 and g = .91, respectively), and 24-month follow-up (g = 1.11 and g = .97, respectively).","['Body Dysmorphic Disorder', '47 adults diagnosed with BDD']","['Internet-Based Cognitive Behavior Therapy', 'Internet-based cognitive-behavior treatment (CBT']","['Yale-Brown Obsessive-Compulsive Scale modified for BDD', 'Sudden Gains', 'sudden gains', 'sudden gainers vs. gradual gainers', 'sudden gain']","[{'cui': 'C0005887', 'cui_str': 'Body dysmorphic disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0049759', 'cui_str': ""7,7'-dimethoxy-(4,4'-bi-1,3-benzodioxole)-5,5'-dicarboxylic acid dimethyl ester""}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0049759', 'cui_str': ""7,7'-dimethoxy-(4,4'-bi-1,3-benzodioxole)-5,5'-dicarboxylic acid dimethyl ester""}, {'cui': 'C1276802', 'cui_str': 'Sudden'}, {'cui': 'C0439833', 'cui_str': 'Gradual'}]",47.0,0.0276453,"Compared to non-sudden gainers and to gradual gainers, sudden gainers showed significantly larger improvements on the Yale-Brown Obsessive-Compulsive Scale modified for BDD at posttreatment (g = 1.23 and g = .91, respectively), and at 3-month (g = 1.23 and g = 1.00, respectively), 12-month (g = 1.12 and g = .91, respectively), and 24-month follow-up (g = 1.11 and g = .97, respectively).","[{'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Bjureberg', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet; Stockholm Health Care Services, Stockholm County Council, Stockholm.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Enander', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet.'}, {'ForeName': 'Volen Z', 'Initials': 'VZ', 'LastName': 'Ivanov', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet; Stockholm Health Care Services, Stockholm County Council, Stockholm.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rück', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet; Stockholm Health Care Services, Stockholm County Council, Stockholm.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Fernández de la Cruz', 'Affiliation': 'Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet; Stockholm Health Care Services, Stockholm County Council, Stockholm. Electronic address: lorena.fernandez.de.la.cruz@ki.se.'}]",Behavior therapy,['10.1016/j.beth.2019.11.002']
2163,32800305,Predictors of Dropout in Cognitive Processing Therapy for PTSD: An Examination of Trauma Narrative Content.,"Dropout rates in trauma-focused treatments for adult posttraumatic stress disorder (PTSD) are high. Most research has focused on demographic and pretreatment predictors of dropout, but findings have been inconsistent. We examined predictors of dropout in cognitive processing therapy (CPT) by coding the content of trauma narratives written in early sessions of CPT. Data are from a randomized controlled noninferiority trial of CPT and written exposure therapy (WET) in which CPT showed significantly higher dropout rates than WET (39.7% CPT vs. 6.4% WET). Participants were 51 adults with a primary diagnosis of PTSD who were receiving CPT and completed at least one of three narratives in the early sessions of CPT. Sixteen (31%) in this subsample were classified as dropouts and 35 as completers. An additional 9 participants dropped out but could not be included because they did not complete any narratives. Of the 11 participants who provided a reason for dropout, 82% reported that CPT was too distressing. The CHANGE coding system was used to code narratives for pathological trauma responses (cognitions, emotions, physiological responses) and maladaptive modes of processing (avoidance, ruminative processing, overgeneralization), each on a scale from 0 (absent) to 3 (high). Binary logistic regressions showed that, averaging across all available narratives, more negative emotions described during or around the time of the trauma predicted less dropout. More ruminative processing in the present time frame predicted lower rates of dropout, whereas more overgeneralized beliefs predicted higher rates. In the first impact statement alone, more negative emotions in the present time frame predicted lower dropout rates, but when emotional reactions had a physiological impact, dropout was higher. These findings suggest clinicians might attend to clients' written trauma narratives in CPT in order to identify indicators of dropout risk and to help increase engagement.",2020,"More ruminative processing in the present time frame predicted lower rates of dropout, whereas more overgeneralized beliefs predicted higher rates.","['11 participants who provided a reason for dropout, 82% reported that', 'PTSD', 'Participants were 51 adults with a primary diagnosis of PTSD who were receiving CPT and completed at least one of three narratives in the early sessions of CPT', 'adult posttraumatic stress disorder (PTSD']","['cognitive processing therapy (CPT', 'CPT and written exposure therapy (WET', 'CPT']","['pathological trauma responses (cognitions, emotions, physiological responses) and maladaptive modes of processing (avoidance, ruminative processing, overgeneralization', 'negative emotions']","[{'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0025361', 'cui_str': 'Form of thinking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0563151', 'cui_str': 'Overgeneralization'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",51.0,0.0575966,"More ruminative processing in the present time frame predicted lower rates of dropout, whereas more overgeneralized beliefs predicted higher rates.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Alpert', 'Affiliation': 'University of Delaware. Electronic address: ealpert@udel.edu.'}, {'ForeName': 'Adele M', 'Initials': 'AM', 'LastName': 'Hayes', 'Affiliation': 'University of Delaware.'}, {'ForeName': 'J Ben', 'Initials': 'JB', 'LastName': 'Barnes', 'Affiliation': 'University of Delaware.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Sloan', 'Affiliation': 'VA Boston Healthcare System, National Center for PTSD; Boston University School of Medicine.'}]",Behavior therapy,['10.1016/j.beth.2019.11.003']
2164,32800383,"Effects of Food on the Pharmacokinetic Properties of Surufatinib: A Phase I, Single-dose, Randomized, Open-label Crossover Study in Healthy Subjects.","PURPOSE


Surufatinib is a potent and orally active small-molecule tyrosine kinase inhibitor targeting VEGFRs 1 to 3, FGFR-1, and CSF-1R, and thus may exert antitumor and antiangiogenic effects. The objective of this study was to determine the tolerability and effects of food intake on the pharmacokinetic properties of surufatinib in healthy Chinese subjects.
METHODS


A total of 24 healthy Chinese male subjects aged between 18 and 55 years were enrolled. Subjects were administered a single dose of surufatinib 250-mg capsules in the fasted and fed states in succession. Pharmacokinetic analysis was performed through the collection of blood samples at predose and at several time points after surufatinib administration. Tolerability assessments comprised physical examination including vital sign measurements, laboratory testing, and ECG to determine adverse events (AEs).
FINDINGS


The 90% CIs of the geometric mean ratios of AUC 0-t  and AUC 0-∞  in the fasted and fed states was within 0.80 to 1.25; and for C max , within 0.70 to 1.43, indicating that food had no effect on the bioavailability of surufatinib in these healthy Chinese male subjects. Food intake delayed the time to peak absorption of surufatinib, as the median T max  in the fed state was longer than that in the fasted state (4.0 vs 2.0 h). Surufatinib was marginally excreted from urine (mean [SD] cumulative excretion fraction, 1.2% [0.4%]). AEs occurred in 7 of the 24 subjects (29.2%) and included upper respiratory tract infection, dizziness, merycism, intervertebral disc protrusion, influenza-like disease, hematuria, prostatitis, and elevated blood urea nitrogen. All AEs were grade 1 or 2.
IMPLICATIONS


The bioavailability of surufatinib was not affected by food intake prior to dosing. However, food intake led to delated T max  of surufatinib. The tolerability of a single oral dose of surufatinib 250 mg in the fasted and fed states was favorable in these healthy Chinese male subjects. These results indicate that surufatinib capsules could be administered before or after meals. ClinicalTrials.gov identifier: NCT02320409.",2020,"AEs occurred in 7 of the 24 subjects (29.2%) and included upper respiratory tract infection, dizziness, merycism, intervertebral disc protrusion, influenza-like disease, hematuria, prostatitis, and elevated blood urea nitrogen.","['24 healthy Chinese male subjects aged between 18 and 55 years were enrolled', 'healthy Chinese male subjects', 'healthy Chinese subjects', 'Surufatinib', 'Healthy Subjects']",['food intake'],"['Food intake delayed the time to peak absorption of surufatinib, as the median T max', 'bioavailability of surufatinib', 'Tolerability assessments comprised physical examination including vital sign measurements, laboratory testing, and ECG to determine adverse events (AEs', 'geometric mean ratios of AUC 0-t  and AUC 0-∞', 'included upper respiratory tract infection, dizziness, merycism, intervertebral disc protrusion, influenza-like disease, hematuria, prostatitis, and elevated blood urea nitrogen']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0013470', 'cui_str': 'Eating'}]","[{'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0242362', 'cui_str': 'Intervertebral disc prolapse'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0033581', 'cui_str': 'Prostatitis'}, {'cui': 'C0151539', 'cui_str': 'Blood urea increased'}]",24.0,0.0918436,"AEs occurred in 7 of the 24 subjects (29.2%) and included upper respiratory tract infection, dizziness, merycism, intervertebral disc protrusion, influenza-like disease, hematuria, prostatitis, and elevated blood urea nitrogen.","[{'ForeName': 'Hongjie', 'Initials': 'H', 'LastName': 'Qian', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Emergency, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jingying', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Hutchison MediPharma Ltd, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Sai', 'Affiliation': 'Hutchison MediPharma Ltd, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Hutchison MediPharma Ltd, Shanghai, China.'}, {'ForeName': 'Yanmei', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Central Laboratory, Shanghai Xuhui Central Hospital/Zhongshan-Xuhui Hospital, Fudan University, Shanghai, China; Shanghai Engineering Research Center of Phase I Clinical Research and Quality Consistency Evaluation for Drugs, Shanghai, China. Electronic address: ymliu@shxh-centerlab.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.07.010']
2165,32800385,High protein versus medium protein delivery under equal total energy delivery in critical care: A randomized controlled trial.,"BACKGROUND


Appropriate protein delivery amounts during the acute phase of critical care are unknown. Along with nutrition, early mobilization and the combination are important. We conducted a randomized controlled trial during critical care to assess high-protein and medium-protein delivery under equal total energy delivery with and without active early rehabilitation.
METHODS


ICU patients of August 2018-September 2019 were allocated to a high-protein group (target energy 20 kcal/kg/day, protein 1.8 g/kg/day) or a medium-protein group (target energy 20 kcal/kg/day, protein 0.9 g/kg/day) with the same nutrition protocol by day 10. By dividing the study period, standard rehabilitation was administered during the initial period. Rehabilitation with belt-type electrical muscle stimulation was given from day 2 in the latter as a historical comparison. Femoral muscle volume was evaluated on day 1 and day 10 using computed tomography.
RESULTS


This study analyzed 117 eligible patients with similar characteristics assigned to a high-protein or medium-protein group. Total energy delivery was around 20 kcal/kg/day in both groups, but protein delivery was 1.5 g/kg/day and 0.8 g/kg/day. As a primary outcome, femoral muscle volume loss was 12.9 ± 8.5% in the high-protein group and 16.9 ± 7.0% in the medium-protein group, with significant difference (p = 0.0059). Persistent inflammation, immunosuppression, and catabolism syndrome were significantly less frequent in the high-protein group. Muscle volume loss was significantly less in the high-protein group only during the electrical muscle stimulation period.
CONCLUSIONS


For critical care, high protein delivery provided better muscle volume maintenance, but only with active early rehabilitation.
REGISTRATION


University Hospital Medical Information Network, UMIN000033783 Registered on 16 Aug 2018. https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038538.",2020,"Persistent inflammation, immunosuppression, and catabolism syndrome were significantly less frequent in the high-protein group.","['critical care', 'ICU patients of August 2018-September 2019', '117 eligible patients with similar characteristics assigned to a high-protein or medium-protein group']","['High protein versus medium protein delivery', 'Rehabilitation with belt-type electrical muscle stimulation', 'high-protein and medium-protein delivery under equal total energy delivery with and without active early rehabilitation', 'high-protein group (target energy 20\xa0kcal/kg/day, protein 1.8\xa0g/kg/day) or a medium-protein']","['Persistent inflammation, immunosuppression, and catabolism syndrome', 'Muscle volume loss', 'femoral muscle volume loss', 'Femoral muscle volume', 'Total energy delivery']","[{'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0452227', 'cui_str': 'Belt'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1690969', 'cui_str': 'Kcal/kg/day'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C1532536', 'cui_str': 'g/kg/day'}]","[{'cui': 'C1265824', 'cui_str': 'Persistent inflammation'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C0543484', 'cui_str': 'catabolism'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",117.0,0.0284124,"Persistent inflammation, immunosuppression, and catabolism syndrome were significantly less frequent in the high-protein group.","[{'ForeName': 'Kensuke', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, 2-1-1, Jonan-cho, Hitachi, Ibaraki, 317-0077, Japan. Electronic address: knakamura-tky@umin.ac.jp.'}, {'ForeName': 'Hidehiko', 'Initials': 'H', 'LastName': 'Nakano', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, 2-1-1, Jonan-cho, Hitachi, Ibaraki, 317-0077, Japan. Electronic address: be.rann1988jp@gmail.com.'}, {'ForeName': 'Hiromu', 'Initials': 'H', 'LastName': 'Naraba', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, 2-1-1, Jonan-cho, Hitachi, Ibaraki, 317-0077, Japan; TXP Medical Co. Ltd., 3-13 Nihonbashiyokoyamacho, Chuo-ku, Tokyo, 103-0003, Japan. Electronic address: nrbhrm@gmail.com.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Mochizuki', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, 2-1-1, Jonan-cho, Hitachi, Ibaraki, 317-0077, Japan. Electronic address: kurakan72@gmail.com.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, 2-1-1, Jonan-cho, Hitachi, Ibaraki, 317-0077, Japan. Electronic address: yuji.mail@icloud.com.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Sonoo', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, 2-1-1, Jonan-cho, Hitachi, Ibaraki, 317-0077, Japan; TXP Medical Co. Ltd., 3-13 Nihonbashiyokoyamacho, Chuo-ku, Tokyo, 103-0003, Japan. Electronic address: sonopy77@gmail.com.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Emergency and Critical Care Medicine, Hitachi General Hospital, 2-1-1, Jonan-cho, Hitachi, Ibaraki, 317-0077, Japan. Electronic address: hidehashimoto-tky@umin.ac.jp.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Morimura', 'Affiliation': 'Department of Emergency and Critical Care Medicine, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo, Tokyo, 113-8655, Japan. Electronic address: molimula@r6.dion.ne.jp.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.07.036']
2166,32800438,Comparison of Postoperative Outcomes Between Traditional Longitudinal Incision and Bikini Incision in Total Hip Arthroplasty via Direct Anterior Approach: A Randomized Controlled Trial.,"BACKGROUND


The purpose of this study is to compare a traditional longitudinal incision to an oblique ""bikini"" incision during total hip arthroplasty (THA) via direct anterior approach (DAA), in terms of the aesthetic appearance of the scar, postoperative functional recovery, and complications.
METHODS


This study is a single-surgeon experience in the Chinese population. Patients who came to our institute needing a THA via DAA were enrolled in our randomized controlled trial and randomly allocated to undergo traditional longitudinal incision (control) or bikini incision. Primary outcomes were measured using the scar cosmesis assessment and rating scale, the visual analog scale for pain, Oxford hip score, and University of California Los Angeles activity-level rating. Secondary outcomes were postoperative serum markers of muscle damage, inflammation, hemoglobin drop, and implant stability. The occurrence of postoperative complications, such as nerve and wound healing, was also recorded.
RESULTS


There were no differences in demographic or clinical characteristics before surgery. A greater proportion of patients in the bikini group were satisfied with the appearance of their scar, giving significantly better scar cosmesis assessment and rating scores. There was no difference in postoperative functional recovery, levels of serum markers, or positioning of the implant components. Incision type had no effect on duration of hospitalization. The incidence of complications did not differ significantly between groups.
CONCLUSION


The bikini incision can improve patients' subjective satisfaction with scar aesthetics after THA via DAA and does not detract from a quick functional recovery. Studies with larger sample sizes should be conducted to further investigate associated complications.
THE CLINICAL TRIAL REGISTRATION NUMBER


ChiCTR1900022870.",2020,The bikini incision can improve patients' subjective satisfaction with scar aesthetics after THA via DAA and does not detract from a quick functional recovery.,"['Chinese population', 'Total Hip Arthroplasty via Direct Anterior Approach', 'Patients who came to our institute needing a THA via DAA']","['Traditional Longitudinal Incision and Bikini Incision', 'oblique ""bikini"" incision during total hip arthroplasty (THA) via direct anterior approach (DAA', 'traditional longitudinal incision (control) or bikini incision']","['scar cosmesis assessment and rating scale, the visual analog scale for pain, Oxford hip score, and University of California Los Angeles activity-level rating', 'postoperative serum markers of muscle damage, inflammation, hemoglobin drop, and implant stability', 'scar cosmesis assessment and rating scores', 'incidence of complications', 'occurrence of postoperative complications, such as nerve and wound healing', 'postoperative functional recovery, levels of serum markers, or positioning of the implant components', 'duration of hospitalization']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205115', 'cui_str': 'Afferent'}, {'cui': 'C0027552', 'cui_str': 'Needed'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1998079', 'cui_str': 'Oxford hip score'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0599766', 'cui_str': 'Recovery of Function'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.0704751,The bikini incision can improve patients' subjective satisfaction with scar aesthetics after THA via DAA and does not detract from a quick functional recovery.,"[{'ForeName': 'Qiuru', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Orthopaedics surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Yue', 'Affiliation': ""Department of Orthopaedics surgery, Karamay Municipal People's Hospital, Karamay, People's Republic of China.""}, {'ForeName': 'Zhouyuan', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopaedics surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Liyile', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopaedics surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Qianhao', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Orthopaedics surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Pengde', 'Initials': 'P', 'LastName': 'Kang', 'Affiliation': ""Department of Orthopaedics surgery, West China Hospital, Sichuan University, Chengdu, People's Republic of China.""}]",The Journal of arthroplasty,['10.1016/j.arth.2020.07.047']
2167,32800469,Women's experiences of outpatient induction of labour with double balloon catheter or prostaglandin pessary: A qualitative study.,"BACKGROUND


One quarter to one third of women experience induction of labour. Outpatient induction of labour may be safe and effective but women's views of this setting and of different methods of induction are sparse.
AIM


To explore women's experiences of outpatient induction of labour with either prostaglandin pessary or double balloon catheter.
METHODS


Qualitative study using semi-structured, audio-recorded interviews with twenty-one women recruited to a feasibility trial of outpatient induction of labour. Transcripts were coded and analysed using a thematic framework approach.
FINDINGS


Two key themes were identified. 'Ownership of induction of labour' concerned how women understood and experienced the induction of labour process and tried to maintain control of a procedure managed by medical professionals. Women felt unprepared for the steps in the process and for the time it would take. The balloon method was preferred as it was considered a gentler start to the process, although some women reported it was painful on insertion. 'Importance of place' reflected women's associations of the home with comfort, ease of support and distraction, and the hospital with safety yet also with discomfort and delays.
DISCUSSION


This sample of women were keen to start induction without hormones. The randomised controlled trial design may have biased the sample towards women who wanted to experience the balloon method and outpatient setting where these were not usually offered, thus further cohort studies would be beneficial.
CONCLUSIONS


Women were positive about experiencing the early stages of induction of labour at home with the balloon catheter.",2020,Ownership of induction of labour' concerned how women understood and experienced the induction of labour process and tried to maintain control of a procedure managed by medical professionals.,"['Qualitative study using semi-structured, audio-recorded interviews with twenty-one women recruited to a feasibility trial of outpatient induction of labour', ""Women's experiences of outpatient induction of labour with"", ""women's experiences of outpatient induction of labour with either"", 'sample towards women who wanted to experience the balloon method and outpatient setting']","['prostaglandin pessary or double balloon catheter', 'double balloon catheter or prostaglandin pessary']",[],"[{'cui': 'C0949415', 'cui_str': 'Qualitative Research'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0031246', 'cui_str': 'Pessary'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}]",[],21.0,0.0394144,Ownership of induction of labour' concerned how women understood and experienced the induction of labour process and tried to maintain control of a procedure managed by medical professionals.,"[{'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Coates', 'Affiliation': 'Centre for Maternal and Child Health Research, School of Health Sciences, City University of London, Northampton Square, London EC1V 0HB, UK. Electronic address: Rose.Coates@city.ac.uk.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Cupples', 'Affiliation': 'St. Georges University Hospital, Maternal-Fetal Research Department, Blackshaw Road, London SW17 0QT, UK. Electronic address: Georgina.Cupples@stgeorges.nhs.uk.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Scamell', 'Affiliation': 'Centre for Maternal and Child Health Research, School of Health Sciences, City University of London, Northampton Square, London EC1V 0HB, UK. Electronic address: Mandie.Scamell.1@city.ac.uk.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'McCourt', 'Affiliation': 'Centre for Maternal and Child Health Research, School of Health Sciences, City University of London, Northampton Square, London EC1V 0HB, UK. Electronic address: Christine.Mccourt.1@city.ac.uk.'}, {'ForeName': 'Amarnath', 'Initials': 'A', 'LastName': 'Bhide', 'Affiliation': 'St. Georges University Hospital, Maternal-Fetal Research Department, Blackshaw Road, London SW17 0QT, UK. Electronic address: abhide@sgul.ac.uk.'}]",Women and birth : journal of the Australian College of Midwives,['10.1016/j.wombi.2020.07.006']
2168,32800473,Contemporary Cytoreductive Nephrectomy Provides Survival Benefit in Clear-cell Metastatic Renal Cell Carcinoma.,"INTRODUCTION


A recent randomized trial questioned the role of cytoreductive nephrectomy in clear-cell metastatic renal cell carcinoma (ccmRCC). We reassessed the effect of cytoreductive nephrectomy on survival in a contemporary population-based ccmRCC cohort.
PATIENTS AND METHODS


Within the Surveillance, Epidemiology, and End Results database (2010-2015), we focused on patients with ccmRCC. The primary endpoint consisted of overall mortality. Univariable and multivariable Cox regression models were applied in the overall cohort and in patients who underwent targeted therapy. Sensitivity analyses included 1:1 propensity score matching, 3- and 6-month landmark analyses, incremental survival benefit analyses, and metastases number and location-based stratifications.
RESULTS


Of 4062 patients with ccmRCC, 2241 (55.1%) received targeted therapy; cytoreductive nephrectomy was performed in 2226 (54.8%) patients and 1168 (52.1%) patients in the overall and targeted therapy cohorts, respectively. Cytoreductive nephrectomy was associated with lower overall mortality in the overall cohort (median survival, 30 vs. 9 months; hazard ratio [HR], 0.43; P < .001), as well as in the targeted therapy cohort (median survival, 28 vs. 12 months; HR, 0.49; P < .001). In sensitivity analyses, cytoreductive nephrectomy was associated with lower overall mortality after 1:1 propensity score-matching (HR, 0.49; P < .001), in 3- and 6-month landmark analyses (HR, 0.49; P < .001 and HR, 0.51; P < .001, respectively), in metastases number and location-based stratifications, except for exclusive liver metastases, as well as in all incremental benefit analyses.
CONCLUSION


Cytoreductive nephrectomy is associated with better survival in patients with ccmRCC, including those exposed to targeted therapy, after adjustment for multiple potential confounders.",2020,"Cytoreductive nephrectomy was associated with lower overall mortality in the overall cohort (median survival, 30 vs. 9 months; hazard ratio [HR], 0.43; P < .001), as well as in the targeted therapy cohort (median survival, 28 vs. 12 months; HR, 0.49; P < .001).","['clear-cell metastatic renal cell carcinoma (ccmRCC', 'patients with ccmRCC', 'Clear-cell Metastatic Renal Cell Carcinoma', '4062 patients with ccmRCC, 2241 (55.1%) received targeted therapy; cytoreductive nephrectomy was performed in 2226 (54.8']","['Cytoreductive nephrectomy', 'cytoreductive nephrectomy']","['incremental survival benefit analyses, and metastases number and location-based stratifications', 'overall mortality', 'survival']","[{'cui': 'C2931852', 'cui_str': 'Clear-cell metastatic renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0027695', 'cui_str': 'Kidney excision'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",4062.0,0.120684,"Cytoreductive nephrectomy was associated with lower overall mortality in the overall cohort (median survival, 30 vs. 9 months; hazard ratio [HR], 0.43; P < .001), as well as in the targeted therapy cohort (median survival, 28 vs. 12 months; HR, 0.49; P < .001).","[{'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Palumbo', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Urology Unit, ASST Spedali Civili of Brescia, Department of Medical and Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy. Electronic address: palumbo.carlotta@gmail.com.'}, {'ForeName': 'Francesco A', 'Initials': 'FA', 'LastName': 'Mistretta', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Department of Urology, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Knipper', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Martini Klinik, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Pecoraro', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Department of Urology, San Luigi Gonzaga Hospital, University of Turin, Orbassano, Turin, Italy.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Tian', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Dzyuba-Negrean', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada.'}, {'ForeName': 'Shahrokh F', 'Initials': 'SF', 'LastName': 'Shariat', 'Affiliation': 'Department of Urology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Saad', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Division of Urology, University of Montreal Hospital Center (CHUM), Montreal, QC, Canada.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Simeone', 'Affiliation': 'Urology Unit, ASST Spedali Civili of Brescia, Department of Medical and Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Berruti', 'Affiliation': 'Medical Oncology Unit, ASST Spedali Civili of Brescia, Department of Medical and Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Briganti', 'Affiliation': 'Division of Experimental Oncology/Unit of Urology, Urological Research Institute (URI), IRCCS San Raffaele Scientific Institute; Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'Division of Urology, Department of Surgery, Juravinski Cancer Centre, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Antonelli', 'Affiliation': 'Urology Unit, ASST Spedali Civili of Brescia, Department of Medical and Surgical Specialties, Radiological Science and Public Health, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Pierre I', 'Initials': 'PI', 'LastName': 'Karakiewicz', 'Affiliation': 'Cancer Prognostics and Health Outcomes Unit, University of Montreal Health Center, Montreal, QC, Canada; Division of Urology, University of Montreal Hospital Center (CHUM), Montreal, QC, Canada.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2020.05.009']
2169,32726529,Respiratory Syncytial Virus Vaccination during Pregnancy and Effects in Infants.,"BACKGROUND


Respiratory syncytial virus (RSV) is the dominant cause of severe lower respiratory tract infection in infants, with the most severe cases concentrated among younger infants.
METHODS


Healthy pregnant women, at 28 weeks 0 days through 36 weeks 0 days of gestation, with an expected delivery date near the start of the RSV season, were randomly assigned in an overall ratio of approximately 2:1 to receive a single intramuscular dose of RSV fusion (F) protein nanoparticle vaccine or placebo. Infants were followed for 180 days to assess outcomes related to lower respiratory tract infection and for 364 days to assess safety. The primary end point was RSV-associated, medically significant lower respiratory tract infection up to 90 days of life, and the primary analysis of vaccine efficacy against the primary end point was performed in the per-protocol population of infants (prespecified criterion for success, lower bound of the 97.52% confidence interval [CI] of ≥30%).
RESULTS


A total of 4636 women underwent randomization, and there were 4579 live births. During the first 90 days of life, the percentage of infants with RSV-associated, medically significant lower respiratory tract infection was 1.5% in the vaccine group and 2.4% in the placebo group (vaccine efficacy, 39.4%; 97.52% CI, -1.0 to 63.7; 95% CI, 5.3 to 61.2). The corresponding percentages for RSV-associated lower respiratory tract infection with severe hypoxemia were 0.5% and 1.0% (vaccine efficacy, 48.3%; 95% CI, -8.2 to 75.3), and the percentages for hospitalization for RSV-associated lower respiratory tract infection were 2.1% and 3.7% (vaccine efficacy, 44.4%; 95% CI, 19.6 to 61.5). Local injection-site reactions among the women were more common with vaccine than with placebo (40.7% vs. 9.9%), but the percentages of participants who had other adverse events were similar in the two groups.
CONCLUSIONS


RSV F protein nanoparticle vaccination in pregnant women did not meet the prespecified success criterion for efficacy against RSV-associated, medically significant lower respiratory tract infection in infants up to 90 days of life. The suggestion of a possible benefit with respect to other end-point events involving RSV-associated respiratory disease in infants warrants further study. (Funded by Novavax and the Bill and Melinda Gates Foundation; ClinicalTrials.gov NCT02624947.).",2020,"Local injection-site reactions among the women were more common with vaccine than with placebo (40.7% vs. 9.9%), but the percentages of participants who had other adverse events were similar in the two groups.
","['Healthy pregnant women, at 28 weeks 0 days through 36 weeks 0 days of gestation, with an expected delivery date near the start of the RSV season', 'A total of 4636 women underwent randomization, and there were 4579 live births', 'Infants', 'pregnant women']","['RSV F protein nanoparticle vaccination', 'RSV fusion (F) protein nanoparticle vaccine or placebo', 'placebo']","['vaccine efficacy', 'RSV-associated, medically significant lower respiratory tract infection', 'percentages for hospitalization for RSV-associated lower respiratory tract infection', 'respiratory tract infection with severe hypoxemia', 'respiratory tract infection', 'adverse events', 'Local injection-site reactions']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C2825543', 'cui_str': 'Estimated date of delivery'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0162768', 'cui_str': 'Fusion protein'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035236', 'cui_str': 'Syncytial Virus, Respiratory'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0149725', 'cui_str': 'Lower respiratory tract infection'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}]",4636.0,0.368944,"Local injection-site reactions among the women were more common with vaccine than with placebo (40.7% vs. 9.9%), but the percentages of participants who had other adverse events were similar in the two groups.
","[{'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Fernando P', 'Initials': 'FP', 'LastName': 'Polack', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Piedra', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Flor M', 'Initials': 'FM', 'LastName': 'Munoz', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Adrian A', 'Initials': 'AA', 'LastName': 'Trenholme', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Eric A F', 'Initials': 'EAF', 'LastName': 'Simões', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Sapeckshita', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Khatija', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'August', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Abdullah H', 'Initials': 'AH', 'LastName': 'Baqui', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Calvert', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Iksung', 'Initials': 'I', 'LastName': 'Cho', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Cotton', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Englund', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Fix', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Gonik', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hammitt', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Heath', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Joanne N', 'Initials': 'JN', 'LastName': 'de Jesus', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Khalil', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Kimberlin', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Romina', 'Initials': 'R', 'LastName': 'Libster', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Conrado J', 'Initials': 'CJ', 'LastName': 'Llapur', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Marilla', 'Initials': 'M', 'LastName': 'Lucero', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Pérez Marc', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Helen S', 'Initials': 'HS', 'LastName': 'Marshall', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Masebole S', 'Initials': 'MS', 'LastName': 'Masenya', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Martinón-Torres', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Meece', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Terry M', 'Initials': 'TM', 'LastName': 'Nolan', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Osman', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Kirsten P', 'Initials': 'KP', 'LastName': 'Perrett', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Joyce S', 'Initials': 'JS', 'LastName': 'Plested', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Richmond', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Julie H', 'Initials': 'JH', 'LastName': 'Shakib', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Shinde', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Stoney', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'D Nigel', 'Initials': 'DN', 'LastName': 'Thomas', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Alan T', 'Initials': 'AT', 'LastName': 'Tita', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Varner', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Manu', 'Initials': 'M', 'LastName': 'Vatish', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Vrbicky', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Wen', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Khalequ', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Zar', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Glenn', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': 'Louis F', 'Initials': 'LF', 'LastName': 'Fries', 'Affiliation': ""From the Medical Research Council, Respiratory and Meningeal Pathogens Research Unit, and the Department of Science and Technology-National Research Foundation, Vaccine Preventable Diseases, University of the Witwatersrand (S.A.M., C.L.C.), and Shandukani Research Centre, Wits Reproductive Health and HIV Institute (M.S.M.), Johannesburg, Setshaba Research Centre, Soshanguve (K.A., A.O.), and the Family Centre for Research with Ubuntu, Department of Paediatrics and Child Health, Stellenbosch University, Tygerberg Hospital (M.F.C.), and the Department of Paediatrics and Child Health, Red Cross War Memorial Children's Hospital, South African Medical Research Council Unit on Child and Adolescent Health, University of Cape Town (H.J.Z.), Cape Town - all in South Africa; Fundación INFANT (F.P.P., R.L.), Hospital Militar Central Dr. Cosme Argerich (G.P.M.), and the National Scientific and Technical Research Council (R.L.), Buenos Aires, and the Department of Pediatric Pulmonology, Hospital del Niño Jesús, Tucumán (C.J.L.) - both in Argentina; the Departments of Pediatrics and Molecular Virology and Microbiology, Baylor College of Medicine, Houston (P.A.P., F.M.M.); the University of Auckland, Middlemore Hospital, Auckland, New Zealand (A.A.T.); the Department of Pediatrics, University of Colorado School of Medicine, and the Children's Hospital Colorado, Center for Global Health, Colorado School of Public Health, Aurora (E.A.F.S.); the Department of Obstetrics and Gynecology, Duke University, Durham, NC (G.K.S.); Novavax (S.A., A.A., J.C., I.C., A.F., J.S.P., V.S., D.N.T., J.W., G.M.G., L.F.F.), Gaithersburg, and the Department of International Health, International Center for Maternal and Newborn Health (A.H.B.), and the Center for American Indian Health, Department of International Health (L.H.), Johns Hopkins Bloomberg School of Public Health, Baltimore - all in Maryland; the Vaccine Institute (A.C., P.T.H.) and the Vascular Biology Research Centre, Molecular and Clinical Sciences Research Institute (A.K.), St. George's, University of London, London, Paediatric Infectious Diseases, Clinical and Experimental Sciences, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton (C.E.J.), and the Oxford Vaccine Group, Department of Paediatrics, University of Oxford and National Institute for Health Research Oxford Biomedical Research Centre (M.D.S.), and the Nuffield Department of Women's and Reproductive Health, University of Oxford (M.V.), Oxford - all in the United Kingdom; the Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle (J.A.E.);the Department of Obstetrics and Gynecology, Wayne State University, Detroit (B.G.); the Research Institute for Tropical Medicine, Muntinlupa, Philippines (J.N.J., M.L.); the Department of Pediatrics (D.W.K.) and the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology and Center for Women's Reproductive Health (A.T.T.), University of Alabama, Birmingham; the Women's and Children's Hospital and Robinson Research Institute, University of Adelaide, Adelaide, SA (H.S.M.), the Melbourne School of Population and Global Health, University of Melbourne, and Murdoch Children's Research Institute, Parkville, VIC (T.M.N., K.P.P.), and Wesfarmers Center of Vaccines and Infectious Diseases, Telethon Kids Institute, Division of Paediatrics, School of Medicine, University of Western Australia, Perth Children's Hospital, Perth (P.C.R., T.S.) - all in Australia; Marshfield Clinic Research Institute, Marshfield, WI (J.K.M.); Pediatría Clínica, Infectología y Traslacional Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain (F.M.-T.); the Division of General Pediatrics, Department of Pediatrics, School of Medicine (J.H.S.), and the Department of Obstetrics and Gynecology (M.W.V.), University of Utah Health Sciences Center, Salt Lake City; Meridian Clinical Research, Norfolk, NE (K.V.); and the International Center for Diarrhoeal Disease Research Bangladesh, Dhaka (K.Z.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1908380']
2170,32726530,Uterine-Artery Embolization or Myomectomy for Uterine Fibroids.,"BACKGROUND


Uterine fibroids, the most common type of tumor among women of reproductive age, are associated with heavy menstrual bleeding, abdominal discomfort, subfertility, and a reduced quality of life. For women who wish to preserve their uterus and who have not had a response to medical treatment, myomectomy and uterine-artery embolization are therapeutic options.
METHODS


We conducted a multicenter, randomized, open-label trial to evaluate myomectomy, as compared with uterine-artery embolization, in women who had symptomatic uterine fibroids and did not want to undergo hysterectomy. Procedural options included open abdominal, laparoscopic, or hysteroscopic myomectomy. The primary outcome was fibroid-related quality of life, as assessed by the score on the health-related quality-of-life domain of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire (scores range from 0 to 100, with higher scores indicating a better quality of life) at 2 years; adjustment was made for the baseline score.
RESULTS


A total of 254 women, recruited at 29 hospitals in the United Kingdom, were randomly assigned: 127 to the myomectomy group (of whom 105 underwent myomectomy) and 127 to the uterine-artery embolization group (of whom 98 underwent embolization). Data on the primary outcome were available for 206 women (81%). In the intention-to-treat analysis, the mean (±SD) score on the health-related quality-of-life domain of the UFS-QOL questionnaire at 2 years was 84.6±21.5 in the myomectomy group and 80.0±22.0 in the uterine-artery embolization group (mean adjusted difference with complete case analysis, 8.0 points; 95% confidence interval [CI], 1.8 to 14.1; P = 0.01; mean adjusted difference with missing responses imputed, 6.5 points; 95% CI, 1.1 to 11.9). Perioperative and postoperative complications from all initial procedures, irrespective of adherence to the assigned procedure, occurred in 29% of the women in the myomectomy group and in 24% of the women in the uterine-artery embolization group.
CONCLUSIONS


Among women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization. (Funded by the National Institute for Health Research Health Technology Assessment program; FEMME Current Controlled Trials number, ISRCTN70772394.).",2020,"Among women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization.","['women who had symptomatic uterine fibroids and did not want to undergo hysterectomy', 'women who wish to preserve their uterus and who have not had a response to medical treatment, myomectomy and uterine-artery embolization', 'Uterine Fibroids', 'women with symptomatic uterine fibroids', '254 women, recruited at 29 hospitals in the United Kingdom']","['myomectomy', 'Uterine-Artery Embolization or Myomectomy', 'uterine-artery embolization', 'open abdominal, laparoscopic, or hysteroscopic myomectomy', 'myomectomy group (of whom 105 underwent myomectomy', 'uterine-artery embolization group (of whom 98 underwent embolization']","['mean (±SD) score on the health-related quality-of-life domain of the UFS-QOL questionnaire', 'Perioperative and postoperative complications', 'fibroid-related quality of life, as assessed by the score on the health-related quality-of-life domain of the Uterine Fibroid Symptom and Quality of Life (UFS-QOL) questionnaire (scores range', 'fibroid-related quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0729536', 'cui_str': 'Embolization of uterine artery'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]","[{'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0729536', 'cui_str': 'Embolization of uterine artery'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0013931', 'cui_str': 'Embolization - action'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",254.0,0.316936,"Among women with symptomatic uterine fibroids, those who underwent myomectomy had a better fibroid-related quality of life at 2 years than those who underwent uterine-artery embolization.","[{'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Manyonda', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Anna-Maria', 'Initials': 'AM', 'LastName': 'Belli', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Mary-Ann', 'Initials': 'MA', 'LastName': 'Lumsden', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Moss', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'McKinnon', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Lee J', 'Initials': 'LJ', 'LastName': 'Middleton', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Versha', 'Initials': 'V', 'LastName': 'Cheed', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Wu', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Fusun', 'Initials': 'F', 'LastName': 'Sirkeci', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Jane P', 'Initials': 'JP', 'LastName': 'Daniels', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': 'Klim', 'Initials': 'K', 'LastName': 'McPherson', 'Affiliation': ""From St. George's Hospital and Medical School (I.M., A.-M.B.) and Whipps Cross Hospital (F.S.), London, the University of Glasgow, Glasgow (M.-A.L., J.M., O.W.), the University of Birmingham, Birmingham (W.M., L.J.M., V.C.), the University of Nottingham, Nottingham (J.P.D.), and the University of Oxford, Oxford (K.M.) - all in the United Kingdom.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1914735']
2171,32795989,"Personalized Approach Bias Modification Smartphone App (""SWIPE"") to Reduce Alcohol Use Among People Drinking at Hazardous or Harmful Levels: Protocol for an Open-Label Feasibility Study.","BACKGROUND


Alcohol accounts for 5.1% of the global burden of disease and injury, and approximately 1 in 10 people worldwide develop an alcohol use disorder. Approach bias modification (ABM) is a computerized cognitive training intervention in which patients are trained to ""avoid"" alcohol-related images and ""approach"" neutral or positive images. ABM has been shown to reduce alcohol relapse rates when delivered in residential settings (eg, withdrawal management or rehabilitation). However, many people who drink at hazardous or harmful levels do not require residential treatment or choose not to access it (eg, owing to its cost, duration, inconvenience, or concerns about privacy). Smartphone app-delivered ABM could offer a free, convenient intervention to reduce cravings and consumption that is accessible regardless of time and place, and during periods when support is most needed. Importantly, an ABM app could also easily be personalized (eg, allowing participants to select personally relevant images as training stimuli) and gamified (eg, by rewarding participants for the speed and accuracy of responses) to encourage engagement and training completion.
OBJECTIVE


We aim to test the feasibility and acceptability of ""SWIPE,"" a gamified, personalized alcohol ABM smartphone app, assess its preliminary effectiveness, and explore in which populations the app shows the strongest indicators of effectiveness.
METHODS


We aim to recruit 500 people who drink alcohol at hazardous or harmful levels (Alcohol Use Disorders Identification Test score≥8) and who wish to reduce their drinking. Recruitment will be conducted through social media and websites. The participants' intended alcohol use goal (reduction or abstinence), motivation to change their consumption, and confidence to change their consumption will be measured prior to training. Participants will be instructed to download the SWIPE app and complete at least 2 ABM sessions per week for 4 weeks. Recruitment and completion rates will be used to assess feasibility. Four weeks after downloading SWIPE, participants will be asked to rate SWIPE's functionality, esthetics, and quality to assess acceptability. Alcohol consumption, craving, and dependence will be measured prior to commencing the first session of ABM and 4 weeks later to assess whether these variables change significantly over the course of ABM.
RESULTS


We expect to commence recruitment in August 2020 and complete data collection in March 2021.
CONCLUSIONS


This will be the first study to test the feasibility, acceptability, and preliminary effectiveness of a personalized, gamified ABM intervention smartphone app for hazardous or harmful drinkers. Results will inform further improvements to the app, as well as the design of a statistically powered randomized controlled trial to test its efficacy relative to a control condition. Ultimately, we hope that SWIPE will extend the benefits of ABM to the millions of individuals who consume alcohol at hazardous levels and wish to reduce their use but cannot or choose not to access treatment.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000638932p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000638932p.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/21278.",2020,"ABM has been shown to reduce alcohol relapse rates when delivered in residential settings (eg, withdrawal management or rehabilitation).","['hazardous or harmful drinkers', '500 people who drink alcohol at hazardous or harmful levels (Alcohol Use Disorders Identification Test score≥8) and who wish to reduce their drinking', 'People Drinking at Hazardous or Harmful Levels', 'August 2020 and complete data collection in March 2021']","['ABM', 'ANZCTR', 'computerized cognitive training intervention', 'Smartphone app-delivered ABM']","[""rate SWIPE's functionality, esthetics, and quality to assess acceptability"", 'Alcohol consumption, craving, and dependence', 'alcohol relapse rates']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",,0.0972027,"ABM has been shown to reduce alcohol relapse rates when delivered in residential settings (eg, withdrawal management or rehabilitation).","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Manning', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Richmond, Victoria, Australia.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Piercy', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Richmond, Victoria, Australia.'}, {'ForeName': 'Joshua Benjamin Bernard', 'Initials': 'JBB', 'LastName': 'Garfield', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Richmond, Victoria, Australia.'}, {'ForeName': 'Dan Ian', 'Initials': 'DI', 'LastName': 'Lubman', 'Affiliation': 'Monash Addiction Research Centre, Eastern Health Clinical School, Monash University, Richmond, Victoria, Australia.'}]",JMIR research protocols,['10.2196/21278']
2172,32795990,App Technology to Support Physical Activity and Intake of Vitamins and Minerals After Bariatric Surgery (the PromMera Study): Protocol of a Randomized Controlled Clinical Trial.,"BACKGROUND


To optimize postoperative outcomes after bariatric surgery, lifestyle changes including increased physical activity are needed. Micronutrient deficiency after surgery is also common and daily supplementation is recommended.
OBJECTIVE


The aim of the PromMera study is to evaluate the effects of a 12-week smartphone app intervention on promotion of physical activity (primary outcome) and adherence to postsurgery vitamin and mineral supplementation, as well as on other lifestyle factors and overall health in patients undergoing bariatric surgery.
METHODS


The PromMera study is a two-arm, randomized controlled trial comprising patients undergoing bariatric surgery. Participants are randomized postsurgery 1:1 to either the intervention group (ie, use of the PromMera app for 12 weeks) or the control group receiving only standard care. Clinical and lifestyle variables are assessed pre- and postsurgery after 18 weeks (postintervention assessment), 6 months, 1 year, and 2 years. Assessments include body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors. Physical activity is objectively measured using the ActiGraph wGT3X-BT triaxial accelerometer.
RESULTS


A total of 154 participants have been enrolled in the study. The last study participant was recruited in May 2019. Data collection will be complete in May 2021.
CONCLUSIONS


Implementing lifestyle changes are crucial after bariatric surgery and new ways to reach patients and support such changes are needed. An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03480464; https://clinicaltrials.gov/ct2/show/NCT03480464.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/19624.",2020,"An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients.
","['patients undergoing bariatric surgery', '154 participants have been enrolled in the study']","['control group receiving only standard care', 'postsurgery vitamin and mineral supplementation', 'Vitamins and Minerals', 'smartphone app intervention']","['Physical activity', 'body composition using Tanita or BOD POD analyzers, muscle function using handgrip, biomarkers in blood, and an extensive questionnaire on lifestyle factors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0556112', 'cui_str': 'Mineral supplement'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]",154.0,0.129942,"An app-based intervention is easily delivered at any time and can be a key factor in the adoption of healthier behavioral patterns in this rapidly growing group of patients.
","[{'ForeName': 'Stephanie Erika', 'Initials': 'SE', 'LastName': 'Bonn', 'Affiliation': 'Clinical Epidemiology Division, Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hult', 'Affiliation': 'Clinical Epidemiology Division, Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Spetz', 'Affiliation': 'Department of Surgery, Linköping University, Norrköping, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Löf', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Andersson', 'Affiliation': 'Department of Surgery, Linköping University, Norrköping, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Wiren', 'Affiliation': 'Department of Surgery, Ersta Hospital, Stockholm, Sweden.'}, {'ForeName': 'Ylva', 'Initials': 'Y', 'LastName': 'Trolle Lagerros', 'Affiliation': 'Clinical Epidemiology Division, Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden.'}]",JMIR research protocols,['10.2196/19624']
2173,32796016,Does the Spraino low-friction shoe patch prevent lateral ankle sprain injury in indoor sports? A pilot randomised controlled trial with 510 participants with previous ankle injuries.,"BACKGROUND


Lateral ankle sprains are common in indoor sports. High shoe-surface friction is considered a risk factor for non-contact lateral ankle sprains. Spraino is a novel low-friction patch that can be attached to the outside of sports shoes to minimise friction at the lateral edge, which could mitigate the risk of such injury. We aimed to determine preliminary effectiveness (incidence rate and severity) and safety (harms) of Spraino to prevent lateral ankle sprains among indoor sport athletes.
METHODS


In this exploratory, parallel-group, two-arm pilot randomised controlled trial, 510 subelite indoor sport athletes with a previous lateral ankle sprain were randomly allocated (1:1) to Spraino or 'do-as-usual'. Allocation was concealed and the trial was outcome assessor blinded. Match and training exposure, number of injuries and associated time loss were captured weekly via text messages. Information on harms, fear-of-injury and ankle pain was also documented.
RESULTS


480 participants completed the trial. They reported a total of 151 lateral ankle sprains, of which 96 were categorised as non-contact, and 50 as severe. All outcomes favoured Spraino with incidence rate ratios of 0.87 (95% CI 0.62 to 1.23) for all lateral ankle sprains; 0.64 (95% CI 0.42 to 0.98) for non-contact lateral ankle sprains; and 0.47 (95% CI 0.25 to 0.88) for severe lateral ankle sprains. Time loss per injury was also lower in the Spraino group (1.8 vs 2.8 weeks, p=0.014). Six participants reported minor harms because of Spraino.
CONCLUSION


Compared with usual care, athletes allocated to Spraino had a lower risk of lateral ankle sprains and less time loss, with only few reported minor harms.
TRIAL REGISTRATION NUMBER


NCT03311490.",2020,"Compared with usual care, athletes allocated to Spraino had a lower risk of lateral ankle sprains and less time loss, with only few reported minor harms.
","['480 participants completed the trial', '510 participants with previous ankle injuries', 'lateral ankle sprains among indoor sport athletes', '510 subelite indoor sport athletes with a previous lateral ankle sprain']","[""Spraino or 'do-as-usual"", 'Spraino']","['incidence rate ratios', 'Time loss per injury', 'risk of lateral ankle sprains and less time loss', 'harms, fear-of-injury and ankle pain', 'Match and training exposure, number of injuries and associated time loss', 'severe lateral ankle sprains']","[{'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517800', 'cui_str': '510'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0085111', 'cui_str': 'Injury of ankle'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]",[],"[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0160087', 'cui_str': 'Sprain of ankle'}, {'cui': 'C2874943', 'cui_str': 'Fear of injury'}, {'cui': 'C0238656', 'cui_str': 'Ankle pain'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",510.0,0.302455,"Compared with usual care, athletes allocated to Spraino had a lower risk of lateral ankle sprains and less time loss, with only few reported minor harms.
","[{'ForeName': 'Filip Gertz', 'Initials': 'FG', 'LastName': 'Lysdal', 'Affiliation': 'Department of Health Science and Technology, Sport Sciences, Aalborg University, Aalborg, Denmark fgly@hst.aau.dk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bandholm', 'Affiliation': 'Department of Physical and Occupational Therapy, Physical Medicine and Rehabilitation Research-Copenhagen, Amager-Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Janne Schurmann', 'Initials': 'JS', 'LastName': 'Tolstrup', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark.'}, {'ForeName': 'Mikkel Bek', 'Initials': 'MB', 'LastName': 'Clausen', 'Affiliation': 'Department of Orthopedic Surgery, Sports Orthopedic Research Center-Copenhagen, Amager-Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mann', 'Affiliation': 'Clinical Research Centre, Amager-Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Pelle Baggesgaard', 'Initials': 'PB', 'LastName': 'Petersen', 'Affiliation': 'Section for Surgical Pathophysiology 7621, Rigshospitalet, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Thor Buch', 'Initials': 'TB', 'LastName': 'Grønlykke', 'Affiliation': 'Spraino ApS, Copenhagen, Denmark.'}, {'ForeName': 'Uwe G', 'Initials': 'UG', 'LastName': 'Kersting', 'Affiliation': 'Department of Health Science and Technology, Sport Sciences, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Eamonn', 'Initials': 'E', 'LastName': 'Delahunt', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Thorborg', 'Affiliation': 'Department of Physical and Occupational Therapy, Physical Medicine and Rehabilitation Research-Copenhagen, Amager-Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101767']
2174,32796054,Economic evaluation of computerised interpretation of fetal heart rate during labour: a cost-consequence analysis alongside the INFANT study.,"OBJECTIVE


Economic evaluation of computerised decision-support software intended to assist in the interpretation of a cardiotocography (CTG) during birth.
DESIGN


Individual patient level data from the INFANT study (an unmasked randomised controlled trial).
SETTING


Maternity units in the UK and Ireland.
POPULATION


Singleton or twin pregnancy women of 35 weeks' gestation or more and receiving continuous electronic fetal monitoring during labour.
INTERVENTION


Computerised decision-support software.
METHODS


Cost-consequence analysis presenting costs and outcomes with a time horizon of 2 years from a government healthcare perspective. Unit cost data collected from a combination of primary and secondary sources.
MAIN OUTCOME MEASURES


Primary clinical outcomes were (i) composite 'poor neonatal outcome' and (ii) developmental assessment at age 2 years in a subset of surviving children. Mean cost per mother and infant dyad from birth to hospital discharge, and from hospital discharge to 24 months follow-up. Maternal health-related quality of life was assessed at 12 and 24 months follow-up using the EuroQol three-level health-related quality of life instrument (EQ-5D-3L).
RESULTS


Data were analysed for 46 042 women and 46 614 infants. No statistically significant differences were detected between trial arms in any of the primary clinical outcomes or maternal quality of life. No statistically significant differences in costs were detected in maternal or infant costs from trial entry to hospital discharge or overall from hospital discharge to 2-year follow-up.
CONCLUSIONS


Decision-support software during labour is not associated with additional maternal or infant benefits and over a 2-year period the software did not lead to additional costs or savings to the National Health Service.
TRIAL REGISTRATION NUMBER


ISRCTN98680152.",2020,"No statistically significant differences in costs were detected in maternal or infant costs from trial entry to hospital discharge or overall from hospital discharge to 2-year follow-up.
","['Maternity units in the UK and Ireland', '2\u2009years from a government healthcare perspective', 'Data were analysed for 46\u2009042 women and 46\u2009614 infants', 'fetal heart rate during labour', ""Singleton or twin pregnancy women of 35 weeks' gestation or more and receiving continuous electronic fetal monitoring during labour""]",[],"['Mean cost per mother and infant dyad from birth to hospital discharge, and from hospital discharge', 'costs', 'maternal quality of life', 'Maternal health-related quality of life', ""i) composite 'poor neonatal outcome' and (ii) developmental assessment at age 2\u2009years in a subset of surviving children""]","[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0007208', 'cui_str': 'CTG, Antepartum'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",,0.222213,"No statistically significant differences in costs were detected in maternal or infant costs from trial entry to hospital discharge or overall from hospital discharge to 2-year follow-up.
","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Schroeder', 'Affiliation': 'Centre for the Health Economy, Macquarie University, Sydney, New South Wales, Australia.'}, {'ForeName': 'Miaoqing', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': 'National Perinatal Epidemiology Unit (NPEU), Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brocklehurst', 'Affiliation': 'Birmingham Clinical Trials Unit, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': 'National Perinatal Epidemiology Unit (NPEU), Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Rivero-Arias', 'Affiliation': 'National Perinatal Epidemiology Unit (NPEU), Nuffield Department of Population Health, University of Oxford, Oxford, UK oliver.rivero@npeu.ox.ac.uk.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2020-318806']
2175,32798144,Study protocol for a multi-institutional randomized phase III study comparing combined everolimus plus lanreotide therapy and everolimus monotherapy in patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors; Japan Clinical Oncology Group Study JCOG1901 (STARTER-NET study).,"Everolimus is recognized as one of the standard drugs for the treatment of unresectable or recurrent gastroenteropancreatic neuroendocrine tumors (NET). However, recent evidence has suggested that addition of somatostatin analogs to everolimus may yield better survival outcomes as compared to everolimus alone. In April 2020, we have initiated a randomized phase III trial in Japan, to confirm the superiority of combined everolimus plus lanreotide therapy over everolimus monotherapy in patients with unresectable or recurrent gastroenteropancreatic NETs with poor prognostic factors (Ki-67 labeling index: LI 5%-20% or Ki-67 LI < 5% with diffuse liver metastases). We plan to enroll a total of 250 patients from 76 institutions over an accrual period of 5 years. The primary endpoint is progression-free survival. The key secondary endpoint is overall survival, with response rate, disease control rate, and proportion of patients with adverse events as the other secondary endpoints. This trial is registered with the Japan Registry of Clinical Trials as jRCT1031200023 [https://jrct.niph.go.jp/en-latest-detail/jRCT1031200023].",2020,"The key secondary endpoint is overall survival, with response rate, disease control rate, and proportion of patients with adverse events as the other secondary endpoints.","['250 patients from 76 institutions over an accrual period of 5 years', 'patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors', 'patients with unresectable or recurrent gastroenteropancreatic NETs with poor prognostic factors (Ki-67 labeling index: LI 5%-20% or Ki-67 LI']","['Everolimus', 'combined everolimus plus lanreotide therapy and everolimus monotherapy', 'combined everolimus plus lanreotide therapy over everolimus monotherapy']","['progression-free survival', 'overall survival, with response rate, disease control rate, and proportion of patients with adverse events']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C2930967', 'cui_str': 'Gastro-enteropancreatic neuroendocrine tumor'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0209211', 'cui_str': 'lanreotide'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",250.0,0.0489079,"The key secondary endpoint is overall survival, with response rate, disease control rate, and proportion of patients with adverse events as the other secondary endpoints.","[{'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Shimoyama', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Hijioka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan. Electronic address: shijioka@ncc.go.jp.'}, {'ForeName': 'Nobumasa', 'Initials': 'N', 'LastName': 'Mizuno', 'Affiliation': 'Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Gakuto', 'Initials': 'G', 'LastName': 'Ogawa', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Kataoka', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Katayama', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Nozomu', 'Initials': 'N', 'LastName': 'Machida', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Honma', 'Affiliation': 'Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Hamaguchi', 'Affiliation': 'Department of Gastroenterological Oncology, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Fukuda', 'Affiliation': 'JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Division of Gastric Surgery, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Kanemitsu', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Furuse', 'Affiliation': 'Department of Medical Oncology, Kyorin University, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.],['10.1016/j.pan.2020.07.010']
2176,32798161,Pain after mandibular ramus block harvesting and lateral ridge augmentation with and without involvement of platelet-rich fibrin: a randomized controlled trial.,"The purpose of this study was to evaluate pain after mandibular ramus block harvesting and lateral ridge augmentation. Autogenous bone block grafts were covered with platelet-rich fibrin (PRF) membranes (test group) or deproteinized bovine bone and a resorbable collagen membrane (control group). This study included 27 partially edentulous patients (test = 14, control = 13) with an indication for bone block augmentation before staged implant placement. Postoperative methylprednisolone (32 mg, day 1) and analgesics comprising ibuprofen (400 mg, four times daily) and paracetamol (1 g, four times daily) were prescribed for 1 week. Pain was recorded by the patient on a 100-mm visual analogue scale (VAS), hourly on the day of surgery and daily for the following 7 days. The average (mean ± standard deviation) maximum pain score over the whole observation period was similar in the test (13.6 ± 13.5) and control (21.0 ± 19.9) groups (P = 0.17). In conclusion, harvesting of a mandibular ramus block and lateral ridge augmentation, in conjunction with the pharmacological protocol described, is characterized by low postoperative pain. Adding PRF membranes to the surgical site generally resulted in slightly lower pain perception, although a statistically significant difference between the test and control groups was only identified on day 1 postoperative.",2020,"Adding PRF membranes to the surgical site generally resulted in slightly lower pain perception, although a statistically significant difference between the test and control groups was only identified on day 1 postoperative.","['27 partially edentulous patients (test\u2009=\u200914, control\u2009=\u200913) with an indication for bone block augmentation before staged implant placement']","['Autogenous bone block grafts', 'paracetamol', 'mandibular ramus block harvesting and lateral ridge augmentation with and without involvement of platelet-rich fibrin', 'Postoperative methylprednisolone', 'platelet-rich fibrin (PRF) membranes (test group) or deproteinized bovine bone and a resorbable collagen membrane (control group', 'analgesics comprising ibuprofen']","['100-mm visual analogue scale (VAS', 'Pain', 'average (mean\u2009±\u2009standard deviation) maximum pain score', 'pain', 'pain perception']","[{'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C1293164', 'cui_str': 'Bone block procedure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0222748', 'cui_str': 'Structure of ramus of mandible'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",27.0,0.0648931,"Adding PRF membranes to the surgical site generally resulted in slightly lower pain perception, although a statistically significant difference between the test and control groups was only identified on day 1 postoperative.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Hartlev', 'Affiliation': 'Section for Oral Surgery and Oral Pathology, Department of Dentistry and Oral Health, Health, Aarhus University, Aarhus C, Denmark. Electronic address: jens.hartlev@clin.au.dk.'}, {'ForeName': 'S E', 'Initials': 'SE', 'LastName': 'Nørholt', 'Affiliation': 'Section for Oral Surgery and Oral Pathology, Department of Dentistry and Oral Health, Health, Aarhus University, Aarhus C, Denmark; Department of Oral and Maxillofacial Surgery, Aarhus University Hospital, Aarhus N, Denmark.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Schou', 'Affiliation': 'Department of Periodontology, School of Dentistry, Faculty of Health Sciences, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Isidor', 'Affiliation': 'Section for Prosthetic Dentistry, Department of Dentistry and Oral Health Health, Aarhus University, Aarhus C, Denmark.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2020.07.009']
2177,32798172,"Ultrasound-Guided Pecto-Intercostal Fascial Block for Postoperative Pain Management in Cardiac Surgery: A Prospective, Randomized, Placebo-Controlled Trial.","OBJECTIVE


To explore the effect of pecto-intercostal fascial plane block (PIFB) on postoperative opioid requirements, pain scores, lengths of intensive care unit and hospital stays and incidence of postoperative delirium in cardiac surgical patients.
DESIGN


Single- center, prospective, randomized (1:1), quadruple- blinded, placebo-controlled trial.
SETTING


Single center, tertiary- care center.
PARTICIPANTS


The study comprised 80 adult cardiac surgical patients (age >18 y) requiring median sternotomy.
INTERVENTION


Patients were randomly assigned to receive ultrasound-guided PIFB, with either 0.25% bupivacaine or placebo, on postoperative days 0 and 1.
MEASUREMENTS AND MAIN RESULTS


Of the 80 patients randomized, the mean age was 65.78 ± 8.73 in the bupivacaine group and 65.70 ± 9.86 in the placebo group (p = 0.573). Patients receiving PIFB with 0.25% bupivacaine showed a statistically significant reduction in visual analog scale scores (4.8 ± 2.7 v 5.1 ± 2.6; p < 0.001), but the 48-hour cumulative opioid requirement computed as morphine milligram equivalents was similar (40.8 ± 22.4 mg v 49.1 ± 26.9 mg; p = 0.14). There was no difference in the incidence of postoperative delirium between the groups evaluated using the 3-minute diagnostic Confusion Assessment Method (3/40 [7.5%] v 5/40 [12.5%] placebo; p = 0.45).
CONCLUSION


Patients who received PIFB with bupivacaine showed a decline in cumulative opioid consumption postoperatively, but this difference between the groups was not statistically significant. Low incidence of complications and improvement in visual analog scale pain scores suggested that the PIFB can be performed safely in this population and warrants additional studies with a larger sample size.",2020,"There was no difference in the incidence of postoperative delirium between the groups evaluated using the 3-minute diagnostic Confusion Assessment Method (3/40 [7.5%] v 5/40 [12.5%] placebo; p = 0.45).
","['80 adult cardiac surgical patients (age >18 y) requiring median sternotomy', 'cardiac surgical patients', 'Single center, tertiary- care center', 'Cardiac Surgery']","['Placebo', 'pecto-intercostal fascial plane block (PIFB', 'bupivacaine', 'Ultrasound-Guided Pecto-Intercostal Fascial Block', 'ultrasound-guided PIFB, with either 0.25% bupivacaine or placebo', 'placebo']","['48-hour cumulative opioid requirement computed as morphine milligram equivalents', 'visual analog scale scores', 'incidence of postoperative delirium', 'visual analog scale pain scores', 'postoperative opioid requirements, pain scores, lengths of intensive care unit and hospital stays and incidence of postoperative delirium', 'cumulative opioid consumption']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C4517443', 'cui_str': '0.25'}]","[{'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",80.0,0.679881,"There was no difference in the incidence of postoperative delirium between the groups evaluated using the 3-minute diagnostic Confusion Assessment Method (3/40 [7.5%] v 5/40 [12.5%] placebo; p = 0.45).
","[{'ForeName': 'Tanvi', 'Initials': 'T', 'LastName': 'Khera', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Kadhiresan R', 'Initials': 'KR', 'LastName': 'Murugappan', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Akiva', 'Initials': 'A', 'LastName': 'Leibowitz', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Noa', 'Initials': 'N', 'LastName': 'Bareli', 'Affiliation': 'Clinical Research Center, Soroka University Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Puja', 'Initials': 'P', 'LastName': 'Shankar', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Gilleland', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Achikam', 'Initials': 'A', 'LastName': 'Oren-Grinberg', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Novack', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Senthilnathan', 'Initials': 'S', 'LastName': 'Venkatachalam', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Valluvan', 'Initials': 'V', 'LastName': 'Rangasamy', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Balachundhar', 'Initials': 'B', 'LastName': 'Subramaniam', 'Affiliation': 'Center for Anesthesia and Research Excellence, Department of Anesthesia Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Boston, MA; Harvard Medical School, Boston, MA. Electronic address: bsubrama@bidmc.harvard.edu.'}]",Journal of cardiothoracic and vascular anesthesia,['10.1053/j.jvca.2020.07.058']
2178,32798174,"Effects of lavender oil intervention before endoscopic retrograde cholangiopancreatography on patients' vital signs, pain and anxiety: A randomized controlled study.","BACKGROUND


This study was carried out to determine the effects of lavender oil intervention before endoscopic retrograde cholangiopancreatography (ERCP) on patients' vital signs, pain and anxiety.
MATERIALS AND METHODS


This study was designed as a randomized controlled study. The population of the study consisted of adult patients who were going to receive ERCP at the gastroenterology clinic of a university hospital. Ninety patients participated in the study. The data were collected using a Patient Information Form, a Pre-Post Test Record Form, VAS and the State Anxiety Scale.
RESULTS


After lavender oil intervention, the pulse rate, systolic-diastolic blood pressure, pain and anxiety levels of the patients in the experiment group were reduced, their oxygen saturation levels were increased, and the difference between the groups was statistically significant (p < 0.05).
CONCLUSION


Lavender oil applied on the patients before the ERCP procedure reduced their pulse rate, systolic-diastolic blood pressure, pain and anxiety levels, while it increased their oxygen saturation levels.",2020,"After lavender oil intervention, the pulse rate, systolic-diastolic blood pressure, pain and anxiety levels of the patients in the experiment group were reduced, their oxygen saturation levels were increased, and the difference between the groups was statistically significant (p < 0.05).
","['Ninety patients participated in the study', 'adult patients who were going to receive ERCP at the gastroenterology clinic of a university hospital', ""patients' vital signs, pain and anxiety""]","['lavender oil intervention before endoscopic retrograde cholangiopancreatography (ERCP', 'lavender oil intervention', 'endoscopic retrograde cholangiopancreatography', 'Lavender oil']","['oxygen saturation levels', 'pulse rate, systolic-diastolic blood pressure, pain and anxiety levels']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C3834491', 'cui_str': 'Gastroenterology clinic'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0064694', 'cui_str': 'lavender oil'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}]","[{'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",90.0,0.0348491,"After lavender oil intervention, the pulse rate, systolic-diastolic blood pressure, pain and anxiety levels of the patients in the experiment group were reduced, their oxygen saturation levels were increased, and the difference between the groups was statistically significant (p < 0.05).
","[{'ForeName': 'Seyhan', 'Initials': 'S', 'LastName': 'Citlik Saritas', 'Affiliation': 'Medical Nursing Department, Faculty of Nursing, Inonu University, 44280 Malatya, Turkey. Electronic address: seyhancitlik@hotmail.com.'}, {'ForeName': 'Zeliha', 'Initials': 'Z', 'LastName': 'Buyukbayram', 'Affiliation': 'Medical Nursing Department, Siirt Health School, Siirt University, Siirt, Turkey.'}, {'ForeName': 'Emine', 'Initials': 'E', 'LastName': 'Kaplan Serin', 'Affiliation': 'Medical Nursing Department, Health School, Munzur University, Tunceli, Turkey.'}, {'ForeName': 'Yilmaz', 'Initials': 'Y', 'LastName': 'Bilgic', 'Affiliation': 'Gastroenterology Department, Medical School, Inonu University, Malatya, Turkey.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.07.011']
2179,32798048,Reply to Letter to the Editor: 'Comparison of virtual reality rehabilitation and conventional rehabilitation in Parkinson's disease: a randomised controlled trial'.,,2020,,"[""Parkinson's disease""]",['virtual reality rehabilitation and conventional rehabilitation'],[],"[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]",[],,0.0697807,,"[{'ForeName': 'Costanza', 'Initials': 'C', 'LastName': 'Pazzaglia', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Imbimbo', 'Affiliation': 'Department of Neurorehabilitation, IRCCS Don Carlo Gnocchi, Milan, Italy.'}, {'ForeName': 'Eliana', 'Initials': 'E', 'LastName': 'Tranchita', 'Affiliation': 'Department of Movement, Human and Health Sciences, Division of Health Sciences, University of Rome Foro Italico, Rome, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Minganti', 'Affiliation': 'Department of Movement, Human and Health Sciences, Division of Health Sciences, University of Rome Foro Italico, Rome, Italy.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Ricciardi', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Rita Lo', 'Initials': 'RL', 'LastName': 'Monaco', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Attilio', 'Initials': 'A', 'LastName': 'Parisi', 'Affiliation': 'Department of Movement, Human and Health Sciences, Division of Health Sciences, University of Rome Foro Italico, Rome, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Padua', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; Department of Geriatrics, Neurosciences and Orthopaedics, Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: luca.padua@unicatt.it.'}]",Physiotherapy,['10.1016/j.physio.2020.07.001']
2180,32798050,Impact of different front-of-pack nutrition labels on online food choices.,"Front-of-pack nutrition labels (FOP-NL) are efficient tools for increasing consumers' awareness of the nutritional quality of food products, prompting healthier food choices. The main goal of this study was to evaluate the impact of four FOP-NL schemes - Traffic Light label (TL), Guideline Daily Amounts (%GDA), Nutri-Score (NS) and Health Star Rating (HSR) - on consumers' selection of food products according to perceived nutritional quality. A cross-sectional open-label crossover randomized controlled study was carried out among Portuguese consumers. A web-based questionnaire was used to assess participants' a) preferences regarding FOP-NLs and b) capacity to select healthy products in a food selection task using the information from FOP-NL schemes. When performing the selection task, participants had the option to indicate that they could not decide simply based on the presented FOP-NL (requiring more information). Overall, 357 adults participated in the study. Regarding consumers' preferences, TL received the most favorable responses, while NS received the fewest. All FOP-NLs performed better than the no-nutritional label control condition in the food selection task. The highest proportion of correct choices was obtained for TL (72.3%), followed by HSR (70.9%), %GDA (70.0%) and NS (62.2%), though no significant differences were found among FOP-NLs. Percentages of respondents indicating not being able to answer due to lack of information affected the proportion of correct choices, with 10.3% for TL, 12.9% for %GDA, 14.6% for HSR, and 25.8% for NS, indicating they were unable to choose without additional information. Although no particular FOP-NL system stood out as the most significantly effective, TL was the most preferred by Portuguese adults. Long-term real-world evidence is necessary to assess the impact of FOP-NL systems on individuals' food choices.",2020,"The highest proportion of correct choices was obtained for TL (72.3%), followed by HSR (70.9%), %GDA (70.0%) and NS (62.2%), though no significant differences were found among FOP-NLs.","['357 adults participated in the study', 'Portuguese consumers']","['Front-of-pack nutrition labels (FOP-NL', 'FOP-NL schemes - Traffic Light label (TL), Guideline Daily Amounts (%GDA', 'different front-of-pack nutrition labels']","['highest proportion of correct choices', 'Nutri-Score (NS) and Health Star Rating (HSR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032730', 'cui_str': 'Portuguese'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0028711', 'cui_str': 'Nutrition Labeling'}, {'cui': 'C0016037', 'cui_str': 'Progressive myositis ossificans'}, {'cui': 'C0442664', 'cui_str': 'Traffic light'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0523683', 'cui_str': 'Guanine deaminase measurement'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0018757', 'cui_str': 'Research, Health Services'}]",357.0,0.0356447,"The highest proportion of correct choices was obtained for TL (72.3%), followed by HSR (70.9%), %GDA (70.0%) and NS (62.2%), though no significant differences were found among FOP-NLs.","[{'ForeName': 'Osvaldo', 'Initials': 'O', 'LastName': 'Santos', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal; Unbreakable Idea Research, Lda, Painho, Portugal. Electronic address: osantos@medicina.ulisboa.pt.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Alarcão', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal; Centro de Investigação e Estudos de Sociologia (CIES-IUL), Instituto Universitário de Lisboa (ISCTE-IUL), Lisboa, Portugal. Electronic address: valarcao@medicina.ulisboa.pt.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Feteira-Santos', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal. Electronic address: rodrigosantos@medicina.ulisboa.pt.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Fernandes', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal. Electronic address: joao@campus.ul.pt.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Virgolino', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal. Electronic address: avirgolino@medicina.ulisboa.pt.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Sena', 'Affiliation': 'Direção-Geral da Saúde, Lisboa, Portugal. Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal.'}, {'ForeName': 'Carlota Pacheco', 'Initials': 'CP', 'LastName': 'Vieira', 'Affiliation': 'Direção-Geral da Saúde, Lisboa, Portugal. Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal.'}, {'ForeName': 'Maria João', 'Initials': 'MJ', 'LastName': 'Gregório', 'Affiliation': 'Programa Nacional para a Promoção da Alimentação Saudável, Direção-Geral da Saúde, Lisboa, Portugal, Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal; Faculdade de Ciências da Nutrição e Alimentação da Universidade do Porto. Rua do Campo Alegre, 823, 4150-180, Porto, Portugal. Electronic address: mariajoaobg@dgs.min-saude.pt.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Nogueira', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal; Direção-Geral da Saúde, Lisboa, Portugal. Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal; Laboratório de Biomatemática, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal. Electronic address: pnogueira@medicina.ulisboa.pt.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Graça', 'Affiliation': 'Programa Nacional para a Promoção da Alimentação Saudável, Direção-Geral da Saúde, Lisboa, Portugal, Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal; Faculdade de Ciências da Nutrição e Alimentação da Universidade do Porto. Rua do Campo Alegre, 823, 4150-180, Porto, Portugal. Electronic address: pedrograca@fcna.up.pt.'}, {'ForeName': 'Andreia', 'Initials': 'A', 'LastName': 'Costa', 'Affiliation': 'Instituto de Saúde Ambiental, Faculdade de Medicina, Universidade de Lisboa. Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal; Direção-Geral da Saúde, Lisboa, Portugal. Alameda D, Afonso Henriques, 45, 1049-005, Lisboa, Portugal; Escola Superior de Enfermagem de Lisboa, Lisboa, Portugal, Avenida Professor Egas Moniz, 1649-028, Lisboa, Portugal. Electronic address: andreiajsilvadacosta@gmail.com.'}]",Appetite,['10.1016/j.appet.2020.104795']
2181,32798059,"Impact of SLCO4C1 Genotypes, Creatinine, and Spironolactone on Digoxin Population Pharmacokinetic Variables in Patients With Cardiac Insufficiency.","PURPOSE


This study aimed to utilize a population pharmacokinetic method to obtain information about the influence of covariates on the in vivo behavior of digoxin in patients with cardiac insufficiency.
METHODS


A total of 228 therapeutic drug monitoring concentrations were retrospectively collected from 176 inpatients. The patients were randomly divided into a modeling group (n = 126) and a validation group (n = 50). The first-order absorption one-compartment model was used to develop a population pharmacokinetic model from a nonlinear mixed effects modeling approach. Sixteen single nucleotide polymorphisms involved in the pharmacokinetic variables of digoxin were identified by using the MassARRAY system. Various demographic parameters, biochemical test values, concomitant medications, and genetic variants were investigated.
FINDINGS


The typical population value of digoxin CL/F was 5.06 L/h, and the volume of distribution was 211.82 L. The drug CL/F was significantly related to serum creatinine, in a combination of spironolactone and SLCO4C1 genotypes of 2 variants (rs3114660 and rs3114661). Results of model evaluation and internal/external validation indicated a stable and precise performance of the final model.
IMPLICATIONS


For the first time, 2 single nucleotide polymorphisms (rs3114660 and rs3114661) in SLCO4C1 were found to significantly affect the elimination of digoxin in vivo. The final population model may be useful for the individualized dosing of digoxin for patients with cardiac insufficiency.",2020,"The drug CL/F was significantly related to serum creatinine, in a combination of spironolactone and SLCO4C1 genotypes of 2 variants (rs3114660 and rs3114661).","['A total of 228 therapeutic drug monitoring concentrations were retrospectively collected from 176 inpatients', 'patients with cardiac insufficiency', 'Patients With Cardiac Insufficiency']","['digoxin', 'SLCO4C1 Genotypes, Creatinine, and Spironolactone']",['pharmacokinetic variables of digoxin'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1720825', 'cui_str': 'Therapeutic Drug Monitoring'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}]",,0.0185196,"The drug CL/F was significantly related to serum creatinine, in a combination of spironolactone and SLCO4C1 genotypes of 2 variants (rs3114660 and rs3114661).","[{'ForeName': 'Pengqiang', 'Initials': 'P', 'LastName': 'Du', 'Affiliation': ""Department of Pharmacy, Fuwai Central China Cardiovascular Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Aifeng', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, Fuwai Central China Cardiovascular Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Yongcheng', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Department of Pharmacy, Fuwai Central China Cardiovascular Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Ao', 'Initials': 'A', 'LastName': 'Jia', 'Affiliation': ""Department of Pharmacy, Fuwai Central China Cardiovascular Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Yafei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy, Fuwai Central China Cardiovascular Hospital, Central China Fuwai Hospital of Zhengzhou University, Henan Provincial People's Hospital, Zhengzhou, Henan, China.""}, {'ForeName': 'Xingang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing, China. Electronic address: lxg198320022003@163.com.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.07.011']
2182,32798079,Impact of mindfulness-based cognitive therapy on counseling self-efficacy: A randomized controlled crossover trial.,"OBJECTIVE


To investigate the impact of a structured eight-week mindfulness-based cognitive therapy (MBCT) program on counseling self-efficacy among counseling trainees.
METHODS


Undergraduate counseling trainees were randomized to an MBCT group (n = 25) or a waitlist control group (n = 25) with a crossover trial design. Psychological measurements regarding mindfulness, empathy, self-compassion, psychological distress, counseling self-efficacy as well as neuro-physiological measures including frontal midline theta activity, respiration rate, and skin conductance were taken at baseline (T1), after intervention (T2), and six-month follow-up (T3).
RESULTS


Mindfulness training could make significant positive changes in empathy, self-compassion, stress reduction, and counseling self-efficacy with this being backed up by both psychological and neuro-physiological evidence at T2. However, such differences between the two groups had greatly subsided after crossover in which carry-over effect and marked improvement were noted in the study and control group, respectively, at T3. In addition, mindfulness was the most significant determinant that contributed to counseling self-efficacy, followed by psychological distress reduction and self-compassion according to the regression models.
CONCLUSION


Integrating mindfulness into counseling training is beneficial for helping profession trainees.
PRACTICE IMPLICATION


Incorporating mindfulness into counseling training can enhance the necessary ""being mode"" qualities in counseling and address self-care issues during training.",2020,"RESULTS


Mindfulness training could make significant positive changes in empathy, self-compassion, stress reduction, and counseling self-efficacy with this being backed up by both psychological and neuro-physiological evidence at T2.","['counseling trainees', 'Undergraduate counseling trainees']","['MBCT', 'mindfulness-based cognitive therapy', 'structured eight-week mindfulness-based cognitive therapy (MBCT) program', 'counseling training', 'waitlist control group']","['psychological distress reduction and self-compassion', 'Psychological measurements regarding mindfulness, empathy, self-compassion, psychological distress, counseling self-efficacy as well as neuro-physiological measures including frontal midline theta activity, respiration rate, and skin conductance', 'empathy, self-compassion, stress reduction, and counseling self-efficacy', 'counseling self-efficacy']","[{'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}]",25.0,0.0113575,"RESULTS


Mindfulness training could make significant positive changes in empathy, self-compassion, stress reduction, and counseling self-efficacy with this being backed up by both psychological and neuro-physiological evidence at T2.","[{'ForeName': 'Sunny H W', 'Initials': 'SHW', 'LastName': 'Chan', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong. Electronic address: sunny.hw.chan@polyu.edu.hk.'}, {'ForeName': 'Calvin Kai-Ching', 'Initials': 'CK', 'LastName': 'Yu', 'Affiliation': 'Department of Counselling and Psychology, Hong Kong Shue Yan University, Hong Kong.'}, {'ForeName': 'Alex W O', 'Initials': 'AWO', 'LastName': 'Li', 'Affiliation': 'Department of Counselling and Psychology, Hong Kong Shue Yan University, Hong Kong.'}]",Patient education and counseling,['10.1016/j.pec.2020.07.022']
2183,32798096,Coping With Stress Through Texting: An Experimental Study.,"PURPOSE


Texting is used by many adolescents and has the potential to improve well-being, as youth can reach out for support immediately after experiencing a stressful situation. Many studies have examined whether texting is associated with well-being, but few have used experimental designs, preventing causal claims.
METHODS


In this experimental study, 130 adolescents (M age  = 12.41) participated with a same-gender friend whom they texted regularly. Both adolescents completed a task that elicited stress and then engaged in one of the following randomly assigned activities: texting their friend, watching a video on a cellphone (passive-phone condition), or sitting quietly (no activity condition). Participants reported their mood and stress levels after the stress task and again after the activity. Heart rate variability was measured throughout.
RESULTS


Participants who texted their friend reported higher moods (b = -.80, standard error [SE] = .24, p < .001, η p 2  = .09) and lower stress at the end of the study than those in the no activity condition (b = .51, SE = .25, p = .046, η p 2  = .04) and higher moods than adolescents in the passive-phone condition (b = -.74, SE = .25, p = .004, η p 2  = .08). No differences were noted between the passive-phone and no activity conditions. There were no differences in heart rate variability between the three conditions. The effects of texting on mood, self-reported stress, and heart rate variability did not differ by gender.
CONCLUSIONS


Both boys and girls may benefit from texting a friend after experiencing a stressful event.",2020,"RESULTS


Participants who texted their friend reported higher moods (b = -.80, standard error [SE] = .24,",['130 adolescents (M age \xa0= 12.41) participated with a same-gender friend whom they texted regularly'],"['activities: texting their friend, watching a video on a cellphone (passive-phone condition), or sitting quietly (no activity condition']","['mood and stress levels', 'mood, self-reported stress, and heart rate variability', 'heart rate variability', 'passive-phone and no activity conditions', 'Heart rate variability']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0079382', 'cui_str': 'Friend'}]","[{'cui': 'C2004436', 'cui_str': 'Activity therapy'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",130.0,0.0257641,"RESULTS


Participants who texted their friend reported higher moods (b = -.80, standard error [SE] = .24,","[{'ForeName': 'Joanna C', 'Initials': 'JC', 'LastName': 'Yau', 'Affiliation': 'School of Education, University of California, Irvine, California. Electronic address: joannay@usc.edu.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Reich', 'Affiliation': 'School of Education, University of California, Irvine, California.'}, {'ForeName': 'Tao-Yi', 'Initials': 'TY', 'LastName': 'Lee', 'Affiliation': 'Donald Bren School of Information and Computer Sciences, University of California, Irvine, California.'}]",The Journal of adolescent health : official publication of the Society for Adolescent Medicine,['10.1016/j.jadohealth.2020.07.004']
2184,32801008,Diagnostic Accuracy of Fecal Calprotectin Concentration in Evaluating Therapeutic Outcomes of Patients With Ulcerative Colitis.,"BACKGROUND & AIMS


Histologic features of inflammation (histologic inflammation) are associated with clinical relapse in patients with ulcerative colitis (UC). Concentration of fecal calprotectin (FC) can be used to identify patients with mucosal inflammation. We aimed to assess the accuracy of FC measurements in identifying patients with histologic inflammation and to develop a model to predict outcomes of therapy.
METHODS


We performed a post-hoc analysis of data from a phase 4 trial of the efficacy of multi-matrix mesalamine in patients with mild to moderate UC (the MOMENTUM trial). We obtained clinical, endoscopic, and histology data from week 8 (n=639) and week 52 (n=373) of the trial. We used area under the receiver operating characteristic (AUROC) curves to determine the accuracy and optimal cutoff levels of FC in identifying patients with different therapeutic outcomes (clinical remission, endoscopic healing, deep remission, or histologic remission) at week 8 and week 52. We performed multivariable logistic regression analyses to identify factors associated with these outcomes.
RESULTS


Median FC concentrations were lower in patients who achieved outcomes of clinical remission, endoscopic healing, deep remission, or histologic remission vs patients who did not. FC concentration identified patients with endoscopic healing and histologic remission with AURUC curve values of 0.77 and 0.76 at week 8, and 0.79 and 0.80 at week 52, respectively. The optimal FC cutoff concentrations for identification of patients with histologic remission were 75 μg/g at week 8 and 99 μg/g at week 52. In the subpopulation with an endoscopy score of 0, median FC concentrations were lower in patients with histologic remission than in patients with microscopic inflammation at week 8 (30 μg/g vs 140 μg/g AUROC, 0.72) and week 52 (21.5 μg/g vs 134.5 μg/g AUROC, 0.71). At both time points, the optimal FC cutoff concentration was approximately 75 μg/g. Our final prediction model for week 52 histologic remission comprised endoscopic score at week 8, FC concentration at week 8, and histologic activity at baseline and week 8.
CONCLUSIONS


A post-hoc analysis of data from a phase 4 trial found that, even in patients with complete endoscopic healing of UC, FC concentration can be used to discriminate patients with ongoing microscopic inflammation from patients with histologic remission. The optimal cutoff concentration of FC is between 75 and 100 μg/g. ClinicalTrials.gov no: NCT01124149.",2020,"RESULTS


Median FC concentrations were lower in patients who achieved outcomes of clinical remission, endoscopic healing, deep remission, or histologic remission vs patients who did not.","['patients with mucosal inflammation', 'patients with mild to moderate UC', 'Patients With Ulcerative Colitis', 'patients with histologic inflammation', 'patients with ulcerative colitis (UC']",['multi-matrix mesalamine'],"['median FC concentrations', 'histologic activity', 'FC concentration', 'therapeutic outcomes (clinical remission, endoscopic healing, deep remission, or histologic remission', 'clinical remission, endoscopic healing, deep remission, or histologic remission', 'Median FC concentrations', 'Concentration of fecal calprotectin (FC', 'optimal FC cutoff concentration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0127615', 'cui_str': 'mesalamine'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",,0.0659612,"RESULTS


Median FC concentrations were lower in patients who achieved outcomes of clinical remission, endoscopic healing, deep remission, or histologic remission vs patients who did not.","[{'ForeName': 'Toer W', 'Initials': 'TW', 'LastName': 'Stevens', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Gastroenterology and Hepatology, meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'Krisztina', 'Initials': 'K', 'LastName': 'Gecse', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Gastroenterology and Hepatology, meibergdreef 9, Amsterdam, the Netherlands.'}, {'ForeName': 'Jerrold R', 'Initials': 'JR', 'LastName': 'Turner', 'Affiliation': ""Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'de Hertogh', 'Affiliation': 'Department of Pathology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Rubin', 'Affiliation': 'University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL, USA.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Department of Gastroenterology and Hepatology, meibergdreef 9, Amsterdam, the Netherlands. Electronic address: g.dhaens@amc.uva.nl.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.08.019']
2185,32801017,"Oral THC:CBD cannabis extract for refractory chemotherapy-induced nausea and vomiting (CINV): a randomised, placebo-controlled, phase 2 crossover trial.","BACKGROUND


This multi-centre, randomised, double-blinded, placebo-controlled, phase 2/3 trial is aimed to evaluate an oral THC:CBD cannabis extract for prevention of refractory CINV. Here we report the phase 2 component results.
PATIENTS AND METHODS


Eligible patients experienced CINV during moderate-highly emetogenic intravenous chemotherapy despite guideline-consistent anti-emetic prophylaxis. Study treatment consisted of 1 cycle of 1-4 self-titrated capsules oral THC 2.5mg/CBD 2.5mg (TN-TC11M) three times daily, days -1 to 5 and 1 cycle of matching placebo in a crossover design, then blinded patient preference for a 3 rd  cycle. The primary endpoint was the proportion of participants with complete response during 0-120 hours from chemotherapy. 80 participants provided 80% power to detect a 20% absolute improvement with a 2-sided p-value of 0.1.
RESULTS


81 participants were randomised; 72 completing 2 cycles are included in the efficacy analyses and 78 not withdrawing consent are included in safety analyses. Median age was 55 years (range 29-80). 78% were female. Complete response was improved with THC:CBD from 14% to 25% (RR 1.77, 90% CI 1.12, 2.79, P=0.041), with similar effects on absence of emesis, use of rescue medications, absence of significant nausea, and summary scores for the Functional Living Index-Emesis (FLIE). 31% experienced moderate or severe cannabinoid-related adverse events such as sedation, dizziness, disorientation; but 83% of participants preferred cannabis to placebo. No serious adverse events were attributed to THC:CBD.
CONCLUSION


The addition of oral THC:CBD to standard anti-emetics was associated with less nausea and vomiting but additional side effects. Most participants preferred THC:CBD to placebo. Based on these promising results, we plan to recruit an additional 170 participants to complete accrual for the definitive, phase 3, parallel group analysis.",2020,"Complete response was improved with THC:CBD from 14% to 25% (RR 1.77, 90% CI 1.12, 2.79, P=0.041), with similar effects on absence of emesis, use of rescue medications, absence of significant nausea, and summary scores for the Functional Living Index-Emesis (FLIE).","['Eligible patients experienced CINV during moderate-highly emetogenic intravenous chemotherapy despite guideline-consistent anti-emetic prophylaxis', '81 participants were randomised; 72 completing 2 cycles are included in the efficacy analyses and 78 not withdrawing consent are included in safety analyses', 'Median age was 55 years (range 29-80']","['THC:CBD', 'Oral THC:CBD cannabis extract', 'THC 2.5mg/CBD 2.5mg (TN-TC11M', 'placebo']","['nausea and vomiting (CINV', 'Complete response', 'proportion of participants with complete response', 'nausea and vomiting', 'serious adverse events', 'absence of emesis, use of rescue medications, absence of significant nausea, and summary scores for the Functional Living Index-Emesis (FLIE', 'moderate or severe cannabinoid-related adverse events such as sedation, dizziness, disorientation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013973', 'cui_str': 'Emetic'}, {'cui': 'C0413365', 'cui_str': 'Intravenous chemotherapy'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0006864', 'cui_str': 'cannabinoids'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}]",81.0,0.659694,"Complete response was improved with THC:CBD from 14% to 25% (RR 1.77, 90% CI 1.12, 2.79, P=0.041), with similar effects on absence of emesis, use of rescue medications, absence of significant nausea, and summary scores for the Functional Living Index-Emesis (FLIE).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Grimison', 'Affiliation': ""Dept of Medical Oncology, Chris O'Brien Lifehouse. Electronic address: peter.grimison@lh.org.au.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mersiades', 'Affiliation': 'NHMRC Clinical Trials Centre, Sydney.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kirby', 'Affiliation': 'NHMRC Clinical Trials Centre, Sydney.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Lintzeris', 'Affiliation': 'Drug and Alcohol Services, South Eastern Sydney Local Health District, Randwick.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Morton', 'Affiliation': 'NHMRC Clinical Trials Centre, Sydney.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Haber', 'Affiliation': 'Sydney Medical School, University of Sydney, Sydney.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Olver', 'Affiliation': 'Faculty of Medicine, University of Adelaide, Adelaide.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Walsh', 'Affiliation': 'NHMRC Clinical Trials Centre, Sydney.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'McGregor', 'Affiliation': 'Lambert Institute, University of Sydney, Sydney.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Cheung', 'Affiliation': 'NHMRC Clinical Trials Centre, Sydney.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tognela', 'Affiliation': 'Macarthur Cancer Therapy Centre, Campbelltown Hospital, Campbelltown.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hahn', 'Affiliation': ""Consumer Partnership Council, Chris O'Brien Lifehouse, Sydney.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Briscoe', 'Affiliation': 'Mid North Coast Cancer Institute, Coffs Harbour.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aghmesheh', 'Affiliation': 'Dept of Medical Oncology, Wollongong hospital, Sydney.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fox', 'Affiliation': 'Central West Cancer Care Centre, Orange Base Hospital, Orange.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Abdi', 'Affiliation': 'Cancer Care and Haematology Unit, The Tweed Hospital, Tweed Heads.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Clarke', 'Affiliation': 'Norther Cancer Institute, Sydney.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Della-Fiorentina', 'Affiliation': 'Southern Highlands Cancer Centre, Bowral.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shannon', 'Affiliation': 'Nepean Cancer Care Centre, Nepean Hospital, Sydney.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gedye', 'Affiliation': 'Nepean Cancer Care Centre, Nepean Hospital, Sydney.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Begbie', 'Affiliation': 'Department of Medical Oncology, Calvary Mater Newcastle, New South Wales; Mid North Coast Cancer Institute, Port Macquarie, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Simes', 'Affiliation': 'NHMRC Clinical Trials Centre, Sydney.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Stockler', 'Affiliation': 'NHMRC Clinical Trials Centre, Sydney.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.07.020']
2186,32801102,"Associations between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life in patients with focal seizures treated with adjunctive eslicarbazepine acetate: Post hoc analyses of clinical trial results.","The relationships between seizure severity change and patient characteristics, changes in seizure frequency, and health-related quality of life (HRQoL) may be important for determining the overall impact of medication therapy on patients with epilepsy. The objectives of these post hoc analyses of the global Phase III 093-0304 trial (NCT00988429, Study 304) of adjunctive eslicarbazepine acetate (ESL) in patients with refractory focal (partial-onset) seizures (FS) were to evaluate associations between seizure severity change, measured by the Seizure Severity Questionnaire (SSQ), and 1) patient characteristics, 2) seizure frequency change, standardized as the seizure frequency (SSF) per 28-day period, and 3) change in HRQoL, evaluated by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) and the Montgomery-Åsberg Depression Rating Scale (MADRS). The analyses were conducted on the per-protocol population (PPP) of patients who were randomized to a placebo arm (n = 188) or an ESL-active group that included treatment with adjunctive ESL 800 mg once daily (QD; n = 184) or adjunctive ESL 1200 mg QD (n = 175). General linear models (GLM) were used to measure the association between SSQ change and patient baseline characteristics or percentage change in the SSF from baseline. Associations between changes in the SSQ and changes in the QOLIE-31 and MADRS were examined using GLM with patient baseline characteristics as covariates. Subgroup analyses were performed for patients in the ESL-active group and those treated with ESL 800 mg or ESL 1200 mg. Minimal clinically important difference (MCIDs) thresholds were used to assess improvements in SSQ scores. The analyses included 547 per-protocol patients. Patients using 1 antiepileptic drug (AED) at baseline had greater improvements in the SSQ compared with those receiving 2 AEDs (P = 0.0606). Treatment with ESL 1200 mg was significantly associated with clinically meaningful improvements in the SSQ (P = 0.0005). The SSQ improvements were significantly associated with an SSF reduction of ≥75%, compared with no reduction (P < 0.0001). In the PPP and the ESL-active group, SSQ improvements were significantly associated with improvements in QOLIE-31 Total Score (TS; P < 0.0001) and the Seizure Worry (SW; P < 0.0001) and Social Functioning (SF; P = 0.0030) subscales. In the ESL 1200 mg subgroup, SSQ improvements were significantly associated with improvements in QOLIE-31 TS (P < 0.0001) and the SW (P < 0.0001) and Energy/Fatigue (EF; P = 0.0007) subscales. In the ESL 800 mg subgroup, improvements in the SSQ were significantly associated with improvements in QOLIE-31 TS (P = 0.0362) and the SW (P = 0.0241) subscale. There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL. These findings demonstrated that in this clinical trial population, adding ESL to baseline AED therapy had utility for decreasing seizure severity and improving HRQoL. There were no significant associations between changes in seizure severity and changes in depressive symptoms in patients with FS.",2020,There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL.,"['patients with refractory focal (partial-onset) seizures (FS', 'patients with epilepsy', 'patients with focal seizures treated with']","['adjunctive eslicarbazepine acetate', 'adjunctive eslicarbazepine acetate (ESL', 'adjunctive ESL 1200\u202fmg QD', 'ESL-active group that included treatment with adjunctive ESL 800', 'ESL 800\u202fmg or ESL', 'ESL', 'placebo']","['SSF reduction', 'SSQ scores', 'seizure frequency, and health-related quality of life (HRQoL', 'seizure frequency, and health-related quality of life', 'SSQ', 'QOLIE-31 Total Score', 'Seizure Worry', 'QOLIE-31 and MADRS', 'QOLIE-31 TS', 'seizure severity and improving HRQoL', 'Seizure Severity Questionnaire (SSQ), and 1) patient characteristics, 2) seizure frequency change, standardized as the seizure frequency (SSF) per 28-day period, and 3) change in HRQoL, evaluated by the Quality of Life in Epilepsy Inventory-31 (QOLIE-31) and the Montgomery-Åsberg Depression Rating Scale (MADRS', 'Social Functioning', 'seizure severity and changes in depressive symptoms', 'Energy/Fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2725262', 'cui_str': 'Eslicarbazepine acetate'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.147528,There was no significant association between changes in the SSQ and changes in the MADRS in patients treated with ESL.,"[{'ForeName': 'Joyce A', 'Initials': 'JA', 'LastName': 'Cramer', 'Affiliation': 'Yale University School of Medicine and Consultant, Houston, TX 77027, United States of America. Electronic address: joyce.cramer@gmail.com.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Colman', 'Affiliation': 'Covance Inc., Suite 3.02, Level 3, Building A, 97 Waterloo Road, Macquarie Corporate Centre, Macquarie Park, New South Wales 2113, Australia. Electronic address: Sam.Colman@covance.com.'}, {'ForeName': 'Kathryn P', 'Initials': 'KP', 'LastName': 'Anastassopoulos', 'Affiliation': 'Covance Inc., 9801 Washingtonian Blvd., 9th. Floor, Gaithersburg, MD 20878, United States of America. Electronic address: kathryn.anastassopoulos@covance.com.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Grinnell', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Todd.Grinnell@sunovion.com.'}, {'ForeName': 'Darshan', 'Initials': 'D', 'LastName': 'Mehta', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Darshan.Mehta@sunovion.com.'}, {'ForeName': 'G Rhys', 'Initials': 'GR', 'LastName': 'Williams', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America. Electronic address: Gwilym.Williams@sunovion.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107312']
2187,32801130,Risk of Anemia With Metformin Use in Type 2 Diabetes: A MASTERMIND Study.,"OBJECTIVE


To evaluate the association between metformin use and anemia risk in type 2 diabetes, and the time-course for this, in a randomized controlled trial (RCT) and real-world population data.
RESEARCH DESIGN AND METHODS


Anemia was defined as a hemoglobin measure of <11 g/dL. In the A Diabetes Outcome Progression Trial (ADOPT;  n  = 3,967) and UK Prospective Diabetes Study (UKPDS;  n  = 1,473) RCTs, logistic regression was used to model anemia risk and nonlinear mixed models for change in hematological parameters. In the observational Genetics of Diabetes Audit and Research in Tayside Scotland (GoDARTS) population ( n  = 3,485), discrete-time failure analysis was used to model the effect of cumulative metformin exposure on anemia risk.
RESULTS


In ADOPT, compared with sulfonylureas, the odds ratio (OR) (95% CI) for anemia was 1.93 (1.10, 3.38) for metformin and 4.18 (2.50, 7.00) for thiazolidinediones. In UKPDS, compared with diet, the OR (95% CI) was 3.40 (1.98, 5.83) for metformin, 0.96 (0.57, 1.62) for sulfonylureas, and 1.08 (0.62, 1.87) for insulin. In ADOPT, hemoglobin and hematocrit dropped after metformin initiation by 6 months, with no further decrease after 3 years. In UKPDS, hemoglobin fell by 3 years in the metformin group compared with other treatments. At years 6 and 9, hemoglobin was reduced in all treatment groups, with no greater difference seen in the metformin group. In GoDARTS, each 1 g/day of metformin use was associated with a 2% higher annual risk of anemia.
CONCLUSIONS


Metformin use is associated with early risk of anemia in individuals with type 2 diabetes, a finding consistent across two RCTs and replicated in one real-world study. The mechanism for this early fall in hemoglobin is uncertain, but given the time course, is unlikely to be due to vitamin B 12  deficiency alone.",2020,"At years 6 and 9, hemoglobin was reduced in all treatment groups, with no greater difference seen in the metformin group.","['Anemia was defined as a hemoglobin measure of <11 g/dL. In the A Diabetes Outcome Progression Trial (ADOPT;  n  = 3,967) and UK Prospective Diabetes Study (UKPDS;  n  = 1,473) RCTs', 'Type 2 Diabetes', 'individuals with type 2 diabetes']","['Metformin', 'metformin']","['annual risk of anemia', 'Risk of Anemia', 'hemoglobin', 'anemia', 'hemoglobin and hematocrit', 'odds ratio (OR', 'early risk of anemia']","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",,0.042343,"At years 6 and 9, hemoglobin was reduced in all treatment groups, with no greater difference seen in the metformin group.","[{'ForeName': 'Louise A', 'Initials': 'LA', 'LastName': 'Donnelly', 'Affiliation': 'Population Health & Genomics, School of Medicine, University of Dundee, Dundee, U.K.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Dennis', 'Affiliation': 'Institute of Biomedical & Clinical Science, University of Exeter Medical School, Royal Devon & Exeter Hospital, Exeter, U.K.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Institute of Cardiovascular and Medicine Sciences, University of Glasgow, Glasgow, U.K.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Sattar', 'Affiliation': 'Diabetes Trials Unit, Radcliffe Department of Medicine, University of Oxford, Oxford, U.K.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hattersley', 'Affiliation': 'Institute of Biomedical & Clinical Science, University of Exeter Medical School, Royal Devon & Exeter Hospital, Exeter, U.K.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Institute of Cardiovascular and Medicine Sciences, University of Glasgow, Glasgow, U.K.'}, {'ForeName': 'Ewan R', 'Initials': 'ER', 'LastName': 'Pearson', 'Affiliation': 'Population Health & Genomics, School of Medicine, University of Dundee, Dundee, U.K. e.z.pearson@dundee.ac.uk.'}]",Diabetes care,['10.2337/dc20-1104']
2188,32801193,REFRESH protocol: a non-inferiority randomised clinical trial comparing internet and teleconference to in-person 'Managing Fatigue' interventions on the impact of fatigue among persons with multiple sclerosis.,"INTRODUCTION


Multiple sclerosis (MS) is an immune-mediated disease of the central nervous system. It is considered a major cause of non-traumatic disability in young adults. One of the most common and disabling symptoms of MS is fatigue. MS fatigue can impact all aspects of quality of life, including physical, mental and social function. Fortunately, fatigue self-management interventions, such as ' Managing Fatigue: A 6 week energy conservation course' , can decrease the impact of fatigue and improve health-related quality of life. The purpose of this study is to compare three modes of delivering the  Managing Fatigue  intervention-two remote delivery formats (teleconference and internet) and one in-person format-on perceptions of fatigue and its impact on physical, mental and social function.
METHODS AND ANALYSIS


A non-inferiority randomised clinical trial is being conducted to compare the three delivery formats (1:1:1 allocation ratio) among 582 participants with MS living in the Midwestern and Northeastern United States. The hypothesis is that teleconference and internet versions of the intervention are non-inferior to the traditional mode of clinical service delivery (ie, one to one, in person) in terms of the primary outcome of self-reported fatigue impact (ie, Fatigue Impact Scale) and the secondary outcome of health-related quality of life (ie, Multiple Sclerosis Impact Scale). Outcomes are being measured at baseline, 2 months, 3 months and 6 months. The primary analysis tool will be linear mixed effects model. The prespecified inferiority margin for the primary outcome is 10 points. We will also examine whether baseline characteristics (eg, sociodemographic) moderate outcomes of the  Managing Fatigue  intervention and whether changes in self-efficacy and fatigue self-management behaviours mediate changes in outcomes.
ETHICS AND DISSEMINATION


The protocol is approved centrally by the institutional review board at Case Western Reserve University. Eligible participants give consent before being enrolled and randomised into the study. The study results will be disseminated through relevant advocacy organisations, newsletters to participants, publication in peer-reviewed journals and presentations at scientific conferences.
TRIAL REGISTRATION NUMBER


NCT03550170; Pre-results.",2020,"The hypothesis is that teleconference and internet versions of the intervention are non-inferior to the traditional mode of clinical service delivery (ie, one to one, in person) in terms of the primary outcome of self-reported fatigue impact (ie, Fatigue Impact Scale) and the secondary outcome of health-related quality of life (ie, Multiple Sclerosis Impact Scale).","['persons with multiple sclerosis', 'young adults', 'Eligible participants give consent before being enrolled and randomised into the study', '582 participants with MS living in the Midwestern and Northeastern United States']",['Managing Fatigue  intervention-two remote delivery formats (teleconference and internet'],"['MS fatigue', 'quality of life, including physical, mental and social function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0039450', 'cui_str': 'Teleconference'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}]","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",582.0,0.146994,"The hypothesis is that teleconference and internet versions of the intervention are non-inferior to the traditional mode of clinical service delivery (ie, one to one, in person) in terms of the primary outcome of self-reported fatigue impact (ie, Fatigue Impact Scale) and the secondary outcome of health-related quality of life (ie, Multiple Sclerosis Impact Scale).","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Plow', 'Affiliation': 'Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio, USA map208@case.edu.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Packer', 'Affiliation': 'School of Occupational Therapy and School of Health Administration, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Virgil G', 'Initials': 'VG', 'LastName': 'Mathiowetz', 'Affiliation': 'Program in Occupational Therapy, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Preissner', 'Affiliation': 'Department of Occupational Therapy, University of Illinois at Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'Setareh', 'Initials': 'S', 'LastName': 'Ghahari', 'Affiliation': ""School of Rehabilitation Therapy, Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Abdus', 'Initials': 'A', 'LastName': 'Sattar', 'Affiliation': 'School of Medicine, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Bethoux', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Cleveland Clinic, Cleveland, Ohio, USA.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Finlayson', 'Affiliation': ""School of Rehabilitation Therapy, Queen's University, Kingston, Ontario, Canada.""}]",BMJ open,['10.1136/bmjopen-2019-035470']
2189,32801202,"Is untargeted iron supplementation harmful when iron deficiency is not the major cause of anaemia? Study protocol for a double-blind, randomised controlled trial among non-pregnant Cambodian women.","INTRODUCTION


The WHO recommends daily oral iron supplementation for 12 weeks in women and adolescents where anaemia prevalence is greater than 40%. However, if iron deficiency is not a major cause of anaemia, then, at best, untargeted iron supplementation is a waste of resources; at worst, it could cause harm. Further, different forms of iron with varying bioavailability may present greater risks of harm.
METHODS AND ANALYSIS


A 12-week three-arm, double-blind, randomised controlled supplementation trial was conducted in Cambodia to determine if there is potential harm associated with untargeted iron supplementation. We will recruit and randomise 480 non-pregnant women (ages 18-45 years) to receive one of three interventions: 60 mg elemental iron as ferrous sulfate (the standard, commonly used form), 18 mg ferrous bisglycinate (a highly bioavailable iron amino acid chelate) or placebo. We will measure ferritin concentrations (to evaluate non-inferiority between the two forms of iron), as well as markers of potential harm in blood and stool (faecal calprotectin, gut pathogen abundance and DNA damage) at baseline and 12 weeks. Mixed-effects generalised linear models will be used to assess the effect of iron on ferritin concentration and markers of potential harm at 12 weeks.
ETHICS AND DISSEMINATION


Ethical approval was obtained from the University of British Columbia Clinical Research Ethics Board (H18-02610), the Children's and Women's Health Centre of British Columbia Research Ethics Board (H18-02610) and the National Ethics Committee for Health Research in Cambodia (273-NECHR). Findings will be published in peer-reviewed journals, presented to stakeholders and policymakers globally and shared within participants' communities.
TRIAL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT04017598).",2020,"We will recruit and randomise 480 non-pregnant women (ages 18-45 years) to receive one of three interventions: 60 mg elemental iron as ferrous sulfate (the standard, commonly used form), 18 mg ferrous bisglycinate (a highly bioavailable iron amino acid chelate) or placebo.","['non-pregnant Cambodian women', '480 non-pregnant women (ages 18-45 years']","['oral iron supplementation', 'elemental iron as ferrous sulfate (the standard, commonly used form), 18\u2009mg ferrous bisglycinate (a highly bioavailable iron amino acid chelate) or placebo']","['anaemia prevalence', 'potential harm in blood and stool (faecal calprotectin, gut pathogen abundance and DNA damage', 'ferritin concentrations']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C1553323', 'cui_str': 'Cambodians'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0302583', 'cui_str': 'Iron'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C1721498', 'cui_str': 'ferrous bisglycinate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0007974', 'cui_str': 'Chelating agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0012860', 'cui_str': 'DNA damage'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.77336,"We will recruit and randomise 480 non-pregnant women (ages 18-45 years) to receive one of three interventions: 60 mg elemental iron as ferrous sulfate (the standard, commonly used form), 18 mg ferrous bisglycinate (a highly bioavailable iron amino acid chelate) or placebo.","[{'ForeName': 'Jordie Aj', 'Initials': 'JA', 'LastName': 'Fischer', 'Affiliation': 'Department of Food, Nutrition and Health, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Lulu X', 'Initials': 'LX', 'LastName': 'Pei', 'Affiliation': 'Department of Food, Nutrition and Health, The University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Goldfarb', 'Affiliation': ""Healthy Starts, British Columbia Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Arianne', 'Initials': 'A', 'LastName': 'Albert', 'Affiliation': ""Department of Biostatistics, Women's Health Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Rajavel', 'Initials': 'R', 'LastName': 'Elango', 'Affiliation': ""Healthy Starts, British Columbia Children's Hospital Research Institute, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Hou', 'Initials': 'H', 'LastName': 'Kroeun', 'Affiliation': 'Helen Keller International Cambodia, Phnom Penh, British Columbia, Cambodia.'}, {'ForeName': 'Crystal D', 'Initials': 'CD', 'LastName': 'Karakochuk', 'Affiliation': 'Department of Food, Nutrition and Health, The University of British Columbia, Vancouver, British Columbia, Canada Crystal.Karakochuk@ubc.ca.'}]",BMJ open,['10.1136/bmjopen-2020-037232']
2190,32801255,Restrictive versus liberal transfusion strategy in upper gastrointestinal bleeding: A randomized controlled trial.,"Background


The study aimed at comparing restrictive and liberal transfusion strategy in reducing mortality in patients with upper gastrointestinal bleeding (UGIB).
Methods


This was a single-center, prospective, open-label, non-inferiority, randomized controlled trial conducted over two years. Patients presenting with UGIB were randomized into restrictive (hemoglobin (Hb) <7 g/dl) or liberal (Hb <8 g/dl) transfusion strategy groups. Transfusion was given till patients achieved target Hb of 9 g/dl in restrictive and 10 g/dl in the liberal arms. Patients with exsanguinating bleeding, transfusion within 90 days, recent history of trauma or surgery were excluded. Primary outcome was mortality rate and the secondary outcomes were morbidity, re-bleeding episodes and the need for intervention.
Results


A total of 224 patients were randomized to 112 patients in each group. Demographic characteristics were comparable. 45-day mortality was similar between the two groups (restrictive vs. liberal; 10/112 vs. 12/112; P = 0.65). The number of in-hospital bleeding episodes (12 vs. 9; P = 0.25), incidence of re-bleeding during the 45-day follow-up (13 vs. 14; P = 0.84), need for endoscopic banding for varices (37/112 vs. 39/112, P = 0.99), mean hospital stay (days) (3.21 ± 2.78 vs. 2.73 ± 1.29; P = 0.10) were similar between the two groups.
Conclusion


Restrictive transfusion strategy is non-inferior to liberal transfusion strategy in patients with UGIB.",2020,"The number of in-hospital bleeding episodes (12 vs. 9; P = 0.25), incidence of re-bleeding during the 45-day follow-up (13 vs. 14; P = 0.84), need for endoscopic banding for varices (37/112 vs. 39/112, P = 0.99), mean hospital stay (days) (3.21 ± 2.78 vs. 2.73 ± 1.29; P = 0.10) were similar between the two groups.
","['upper gastrointestinal bleeding', '224 patients were randomized to 112 patients in each group', 'Patients presenting with UGIB', 'patients with UGIB', 'patients with upper gastrointestinal bleeding (UGIB', 'Patients with exsanguinating bleeding, transfusion within 90 days, recent history of trauma or surgery were excluded']","['Restrictive versus liberal transfusion strategy', 'restrictive (hemoglobin (Hb) <7 g/dl) or liberal (Hb <8 g/dl) transfusion strategy groups']","['morbidity, re-bleeding episodes and the need for intervention', 'need for endoscopic banding for varices', '45-day mortality', 'number of in-hospital bleeding episodes', 'mortality rate', 'mean hospital stay', 'incidence of re-bleeding']","[{'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal bleeding'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C1318217', 'cui_str': '8G'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",224.0,0.164073,"The number of in-hospital bleeding episodes (12 vs. 9; P = 0.25), incidence of re-bleeding during the 45-day follow-up (13 vs. 14; P = 0.84), need for endoscopic banding for varices (37/112 vs. 39/112, P = 0.99), mean hospital stay (days) (3.21 ± 2.78 vs. 2.73 ± 1.29; P = 0.10) were similar between the two groups.
","[{'ForeName': 'Gautham', 'Initials': 'G', 'LastName': 'Kola', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'Sathasivam', 'Initials': 'S', 'LastName': 'Sureshkumar', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'Subair', 'Initials': 'S', 'LastName': 'Mohsina', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Sreenath', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Kate', 'Affiliation': 'Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.'}]",Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association,['10.4103/sjg.SJG_152_20']
2191,32801257,Efficacy of single- versus split-dose polyethylene glycol electrolyte solution for morning colonoscopy: A randomized controlled study.,"Background


Split-dose (SPD) regimen has been proved more effective than a single-dose (SID) regimen for various drug preparations; however, limited data have focused on morning colonoscopy. We implemented this study to compare the bowel cleanliness and tolerability of a same-day SID versus SPD 2 L polyethylene glycol electrolyte solution (PEG) for morning colonoscopy.
Methods


Patients undergoing morning colonoscopy were randomized into two groups, SID or SPD. In the SID group, patients had to complete 2 L PEG between 4 and 6 am on the day of colonoscopy. In the SPD group, patients had to complete 1 L PEG between 8 and 9 pm on the day before followed by another 1 L PEG between 5 and 6 am on the day of colonoscopy. Colonoscopy was performed between 8 and 12 am under anesthesia. Investigators and endoscopists were blinded to the allocation. The primary end point was the effectiveness of bowel cleansing according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes were polyp detection rate, compliance, tolerability, and patient satisfaction.
Results


Overall, there were 147 and 148 patients in the SID and SPD group, respectively. The SPD group had a better quality of bowel preparation than the SID group with a total BBPS score of 7.25 ± 1.53 versus 6.71 ± 1.65 (P = 0.005). No difference in the polyp detection rate was noted, although more polyps were detected in the SPD group. More patients felt acceptable with the bowel preparation regimen in the SPD group compared to the SID group (76% vs. 65%, P = 0.03). The adverse events were more commonly observed in the SID group, presented as nausea and vomiting.
Conclusion


For morning colonoscopy, split-dose 2 L PEG is superior to single-dose 2 L PEG by improved bowel preparation, better tolerability, and patient satisfaction.",2020,The SPD group had a better quality of bowel preparation than the SID group with a total BBPS score of 7.25 ± 1.53 versus 6.71 ± 1.65 (P = 0.005).,['Methods\n\n\nPatients undergoing morning colonoscopy'],"['SID or SPD', 'SPD 2 L polyethylene glycol electrolyte solution (PEG', 'Conclusion\n\n\nFor morning colonoscopy', 'single- versus split-dose polyethylene glycol electrolyte solution', '\n\n\nSplit-dose (SPD) regimen']","['polyp detection rate', 'quality of bowel preparation', 'effectiveness of bowel cleansing according to the Boston Bowel Preparation Scale (BBPS', 'nausea and vomiting', 'bowel preparation, better tolerability, and patient satisfaction', 'adverse events', 'polyp detection rate, compliance, tolerability, and patient satisfaction']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C3541941', 'cui_str': 'Electrolyte solutions'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C4302285', 'cui_str': 'BBPS - Boston bowel preparation scale'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",,0.0623581,The SPD group had a better quality of bowel preparation than the SID group with a total BBPS score of 7.25 ± 1.53 versus 6.71 ± 1.65 (P = 0.005).,"[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shan', 'Affiliation': ""Department of Gastroenterology, The Third People's Hospital of Chengdu, The Second Chengdu Hospital Affiliated to Chongqing Medical University, The Affiliated Hospital of Southwest Jiaotong University, Chengdu, Sichuan, China.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Yang', 'Affiliation': ""Department of Gastroenterology, The Third People's Hospital of Chengdu, The Second Chengdu Hospital Affiliated to Chongqing Medical University, The Affiliated Hospital of Southwest Jiaotong University, Chengdu, Sichuan, China.""}, {'ForeName': 'Wenbin', 'Initials': 'W', 'LastName': 'Ran', 'Affiliation': ""Department of Gastroenterology, The Third People's Hospital of Chengdu, The Second Chengdu Hospital Affiliated to Chongqing Medical University, The Affiliated Hospital of Southwest Jiaotong University, Chengdu, Sichuan, China.""}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Xi', 'Affiliation': ""Department of Gastroenterology, The Third People's Hospital of Chengdu, The Second Chengdu Hospital Affiliated to Chongqing Medical University, The Affiliated Hospital of Southwest Jiaotong University, Chengdu, Sichuan, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': ""Department of Gastroenterology, The Third People's Hospital of Chengdu, The Second Chengdu Hospital Affiliated to Chongqing Medical University, The Affiliated Hospital of Southwest Jiaotong University, Chengdu, Sichuan, China.""}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Gastroenterology, The Third People's Hospital of Chengdu, The Second Chengdu Hospital Affiliated to Chongqing Medical University, The Affiliated Hospital of Southwest Jiaotong University, Chengdu, Sichuan, China.""}]",Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association,['10.4103/sjg.SJG_58_20']
2192,32801342,L-DOPA and consolidation of fear extinction learning among women with posttraumatic stress disorder.,"This study tested whether L-DOPA delivered during the consolidation window following fear extinction learning reduces subsequent fear responding among women with PTSD. Adult women diagnosed with PTSD completed a contextual fear acquisition and extinction task during fMRI and then immediately received either placebo (n = 34), 100/25 mg L-DOPA/carbidopa (n = 28), or 200/50 mg L-DOPA/carbidopa (n = 29). Participants completed a resting-state scan before the task and again 45 min following drug ingestion to characterize effects of L-DOPA on extinction memory neural reactivation patterns during consolidation. Twenty-four hours later, participants returned for tests of context renewal, extinction recall, and reinstatement during fMRI with concurrent skin conductance responding (SCR) assessment. Both active drug groups demonstrated increased reactivation of extinction encoding in the amygdala during the post-task resting-state scan. For SCR data, both drug groups exhibited decreased Day 2 reinstatement across all stimuli compared to placebo, and there was some evidence for decreased context renewal to the fear stimulus in the 100 mg group compared to placebo. For imaging data, both drug groups demonstrated decreased Day 2 reinstatement across stimuli in a bilateral insula network compared to placebo. There was no evidence in SCR or neural activity that L-DOPA improved extinction recall. Reactivation of extinction encodings in the amygdala during consolidation on Day 1 predicted Day 2 activation of the insula network. These results support a role for dopamine during the consolidation window in boosting reactivation of amygdala extinction encodings and reducing reinstatement, but not improving extinction recall, in women with PTSD.",2020,"For imaging data, both drug groups demonstrated decreased Day 2 reinstatement across stimuli in a bilateral insula network compared to placebo.","['women with PTSD', 'Adult women diagnosed with PTSD completed a contextual fear acquisition and extinction task during fMRI and then immediately received either', 'women with posttraumatic stress disorder']","['200/50\u2009mg L-DOPA/carbidopa', 'L-DOPA', '100/25\u2009mg L-DOPA/carbidopa', 'L-DOPA and consolidation of fear extinction learning', 'placebo']","['reactivation of extinction encoding', 'SCR or neural activity that L-DOPA improved extinction recall']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0205548', 'cui_str': 'Stat'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",,0.0800658,"For imaging data, both drug groups demonstrated decreased Day 2 reinstatement across stimuli in a bilateral insula network compared to placebo.","[{'ForeName': 'Josh M', 'Initials': 'JM', 'LastName': 'Cisler', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA. jcisler2@wisc.edu.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Privratsky', 'Affiliation': 'University of Arkansas for Medical Sciences, Brain Imaging Research Center, Little Rock, AR, USA.'}, {'ForeName': 'Anneliis', 'Initials': 'A', 'LastName': 'Sartin-Tarm', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA.'}, {'ForeName': 'Kyrie', 'Initials': 'K', 'LastName': 'Sellnow', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Ross', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA.'}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Weaver', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hahn', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Herringa', 'Affiliation': 'Department of Psychiatry, University of Wisconsin Madison, Madison, WI, USA.'}, {'ForeName': 'George Andrew', 'Initials': 'GA', 'LastName': 'James', 'Affiliation': 'University of Arkansas for Medical Sciences, Brain Imaging Research Center, Little Rock, AR, USA.'}, {'ForeName': 'Clinton D', 'Initials': 'CD', 'LastName': 'Kilts', 'Affiliation': 'University of Arkansas for Medical Sciences, Brain Imaging Research Center, Little Rock, AR, USA.'}]",Translational psychiatry,['10.1038/s41398-020-00975-3']
2193,32801436,Trimetazidine Improves the Outcome of EECP Therapy in Patients with Refractory Angina Pectoris.,"Introduction


Cardiovascular disease (CAD) associated with death and disability remains a serious medical problem. In some patients the initial clinical coronary artery disease presentation is stable angina pectoris.
Aim


The aim of the study was to evaluate the effect of EECP therapy with or without trimetazidine (TMZ) in patients with refractory angina via modulating peripheral monocyte expression of Toll like receptor2 (TLR2) and its downstream signaling.
Methods


This is a double-blind randomized prospective study in which 88 stable refractory angina patients allocated into two groups, Enhanced External Counter Pulsation (EECP) group: included 44 patients with stable refractory angina, and were treated with EECP-Therapy. TMZ-EECP group: included 44 patients with stable refractory angina, we gave TMZ 35 mg twice daily in addition to EECP-Therapy.
Results


TLR2 expression in peripheral monocyte investigated by flow cytometry and 8-iso-prostaglandin F2β (8-iso-PGF2 β), interleukin1β (IL-1β), heat shock protein 60 (HSP60) and monocytes chemoattractant protein-1(MCP-1) were also measured before the EECP-therapy and before giving TMZ to patients, and after 35 hours of EECP treatment (7 consecutive weeks). Inhibition in TLR2 expression in peripheral monocyte was observed among the EECP group (P<0.05). Inflammatory cytokine MCP-1 was remarkably decreased in both study groups but (heat shock protein 60 (HSP60), MCP-1 and interleukin-1β (IL-1β)) significantly decreased levels were observed among the TMZ-EECP group (P<0.05). Also, the oxidative stress biomarker 8-iso-prostaglandin F2β (8-iso-PGF2β) was decreased in both study groups but significantly decreased levels were observed among the TMZ-EECP group (P<0.05). TMZ and EECP therapy in patients with stable refractory angina remarkably decreased the inflammatory markers HSP60, MCP-1 and IL-1β in serum levels also the decreased levels were found in serum levels of oxidative stress marker 8-iso-PGF2β serum level.
Conclusion


EECP-therapy decreased the expression of TLR2 on peripheral monocytes in patients with chronic stable refractory angina which yield improvement in the quality of patients' life by decreasing the frequency of angina episodes, decreasing the Short-acting nitrate use and change the exercise tolerance and distance.",2020,"TMZ and EECP therapy in patients with stable refractory angina remarkably decreased the inflammatory markers HSP60, MCP-1 and IL-1β in serum levels also the decreased levels were found in serum levels of oxidative stress marker 8-iso-PGF2β serum level.
","['group: included 44 patients with stable refractory angina, and were treated with', 'patients with chronic stable refractory angina', 'patients with stable refractory angina', 'Patients with Refractory Angina Pectoris', '44 patients with stable refractory angina', 'patients with refractory angina via modulating peripheral monocyte expression of Toll like receptor2 ', '88 stable refractory angina patients']","['Trimetazidine', 'Enhanced External Counter Pulsation (EECP', 'EECP therapy with or without trimetazidine (TMZ', 'EECP', 'TMZ-EECP', 'EECP-therapy', 'EECP-Therapy', 'TMZ 35 mg twice daily in addition to EECP-Therapy', 'EECP Therapy', 'TMZ and EECP therapy', 'TLR2']","['TLR2 expression in peripheral monocyte investigated by flow cytometry and 8-iso-prostaglandin F2β (8-iso-PGF2 β), interleukin1β (IL-1β), heat shock protein 60 (HSP60) and monocytes chemoattractant protein-1(MCP-1', 'Inhibition in TLR2 expression in peripheral monocyte', 'MCP-1 and interleukin-1β (IL-1β', 'oxidative stress biomarker 8-iso-prostaglandin F2β (8-iso-PGF2β', 'Inflammatory cytokine MCP-1', 'inflammatory markers HSP60, MCP-1 and IL-1β in serum levels']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0741032', 'cui_str': 'Refractory angina'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1536180', 'cui_str': 'Refractory angina pectoris'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}]","[{'cui': 'C0041037', 'cui_str': 'Trimetazidine'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0677601', 'cui_str': 'Counter'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1383981', 'cui_str': 'Trimetazidine 35 MG'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}]","[{'cui': 'C1321919', 'cui_str': 'TLR4 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0016263', 'cui_str': 'Flow cytometry'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0012471', 'cui_str': 'Dinoprost'}, {'cui': 'C0109272', 'cui_str': 'hsp60 Protein'}, {'cui': 'C0008013', 'cui_str': 'Chemoattractants'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",44.0,0.0213237,"TMZ and EECP therapy in patients with stable refractory angina remarkably decreased the inflammatory markers HSP60, MCP-1 and IL-1β in serum levels also the decreased levels were found in serum levels of oxidative stress marker 8-iso-PGF2β serum level.
","[{'ForeName': 'Saad Rasool', 'Initials': 'SR', 'LastName': 'Shaker', 'Affiliation': 'Department of Pharmacology and Therapeutics, Faculty of Medicine, University of Kufa, Iraq.'}, {'ForeName': 'Fadhil', 'Initials': 'F', 'LastName': 'Al-Amran', 'Affiliation': 'Department of Cardiothoracic Surgery, Faculty of Medicine, University of Kufa.'}, {'ForeName': 'Ghizal', 'Initials': 'G', 'LastName': 'Fatima', 'Affiliation': 'Department of Biotechnology, Era University, Lucknow, India.'}, {'ForeName': 'Hayder', 'Initials': 'H', 'LastName': 'Al-Aubaid', 'Affiliation': 'La Trobe University, Australia.'}, {'ForeName': 'Najah R', 'Initials': 'NR', 'LastName': 'Hadi', 'Affiliation': 'Department of Pharmacology and Therapeutics, Faculty of Medicine, University of Kufa, Iraq.'}]","Medical archives (Sarajevo, Bosnia and Herzegovina)",['10.5455/medarh.2020.74.199-204']
2194,32801464,Insufficiency of B vitamins with its possible clinical implications.,"Vitamin deficiency causes classical deficiency diseases such as beriberi and rickets. Vitamin insufficiency, which is milder than deficiency, is a risk for various chronic diseases, but its significance has not been recognized in Japan. Vitamin D insufficiency is quite common in Japan, and a serious risk for osteoporotic fracture through its unbeneficial effect on bone and muscle. Insufficiency of B vitamins has been little studied. However, hyperhomocysteinemia caused by the insufficiency of vitamin B 12  or folate is a risk for cardiovascular disease, osteoporotic fracture, and cognitive impairment. Additionally, we have recently reported that vitamin B 1  insufficiency is a risk for heart failure in the elderly. The effect of improvement of nutritional status including vitamins is less marked compared to drug treatment, but it costs far less, and is suited for the primary prevention of diseases. Randomized controlled trial is considered the study with the most robust evidence in the evaluation of drug treatment, but more emphasis should be put on the well-designed cohort studies in evaluating the role of nutrients. Vitamin insufficiency is quite prevalent, and vitamin requirement is much higher for its prevention than for the prevention of deficiency.",2020,"The effect of improvement of nutritional status including vitamins is less marked compared to drug treatment, but it costs far less, and is suited for the primary prevention of diseases.",[],['Vitamin deficiency'],[],[],"[{'cui': 'C0376286', 'cui_str': 'Avitaminosis'}]",[],,0.0787477,"The effect of improvement of nutritional status including vitamins is less marked compared to drug treatment, but it costs far less, and is suited for the primary prevention of diseases.","[{'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Faculty of Nutrition, Kobe Gakuin University, 518 Ikawadanicho-Arise, Nishi, Kobe 651-2180, Japan.'}, {'ForeName': 'Misora', 'Initials': 'M', 'LastName': 'Ao', 'Affiliation': ""Faculty of Health and Nutrition, Osaka Shoin Women's University, 4-2-26 Hishiyanishi, Higashiosaka, Osaka 577-8550, Japan.""}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Clinical Nutrition, Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, 3-7-30 Habikino, Habikino, Osaka 583-8555, Japan.'}]",Journal of clinical biochemistry and nutrition,['10.3164/jcbn.20-56']
2195,32801526,Use of Physics Forceps in Atraumatic Orthodontic Extractions of Bilateral Premolars: A Randomized Control Clinical Study.,"Introduction


Various atraumatic tooth extraction techniques have gained popularity over the last few decades, and numerous instruments have been devised for the same. A pair of physics forceps is one such instrument that maintains the integrity of the gingival and surrounding periodontium while delivering the tooth out of the socket atraumatically. Extractions using these forceps are less invasive over conventional forceps using less intraoperative time but are technique sensitive and have a definitive learning curve.
Aim


To compare the efficacy of physics forceps with conventional forceps in the orthodontic extraction of bilateral premolars and to compare the clinical outcome and complications of each.
Material and Methods


In this prospective randomized split-mouth study, all the patients ( n  = 50) and total premolars ( n  = 200) were divided into two groups, in which first premolars in maxillary and mandibular quadrant on one side were extracted with physics forceps ( n  = 100), whereas those in the other 2 quadrants was done with conventional forceps ( n  = 100). Clinical outcomes in the form of time taken for extraction, postoperative pain, total number of analgesics taken, buccal cortical plate fracture, soft tissue healing after extraction and other complications were recorded and compared.
Results


The mean time for extraction of premolars with physics forceps was significantly less as compared to the conventional forceps ( P  0.001). There was no statistically significant difference in the postoperative pain on any of the postoperative days, between both the groups. No major complication except root fracture was seen in 3 teeth in physics forceps group. Soft tissue healing was similar in both the groups.
Conclusion


Physics forceps are an effective method of atraumatic extraction of premolars as it reduce the intraoperative time significantly and have comparable clinical outcomes as the conventional forceps and are associated with few complications.",2020,The mean time for extraction of premolars with physics forceps was significantly less as compared to the conventional forceps ( P  0.001).,"['Atraumatic Orthodontic Extractions of Bilateral Premolars', 'patients ( n \u2009=\u200950) and total premolars ( n \u2009=\u2009200']","['physics forceps with conventional forceps', 'Physics Forceps', 'conventional forceps']","['Soft tissue healing', 'mean time for extraction of premolars with physics forceps', 'major complication except root fracture', 'postoperative pain', 'time taken for extraction, postoperative pain, total number of analgesics taken, buccal cortical plate fracture, soft tissue healing after extraction and other complications']","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0031837', 'cui_str': 'Physics'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0031837', 'cui_str': 'Physics'}, {'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0007776', 'cui_str': 'Structure of cerebral cortex'}]",200.0,0.0364021,The mean time for extraction of premolars with physics forceps was significantly less as compared to the conventional forceps ( P  0.001).,"[{'ForeName': 'Sarika', 'Initials': 'S', 'LastName': 'Kapila', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Amritsar, Punjab India.'}, {'ForeName': 'Tejinder', 'Initials': 'T', 'LastName': 'Kaur', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Amritsar, Punjab India.'}, {'ForeName': 'Ramandeep Singh', 'Initials': 'RS', 'LastName': 'Bhullar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Amritsar, Punjab India.'}, {'ForeName': 'Amneet', 'Initials': 'A', 'LastName': 'Sandhu', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Amritsar, Punjab India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Dhawan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Amritsar, Punjab India.'}, {'ForeName': 'Amoldeep', 'Initials': 'A', 'LastName': 'Kaur', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Sri Guru Ram Das Institute of Dental Sciences and Research, Amritsar, Punjab India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-020-01347-6']
2196,32803265,Remediating Thirdhand Smoke Pollution in Multiunit Housing: Temporary Reductions and the Challenges of Persistent Reservoirs.,"INTRODUCTION


Toxic tobacco smoke residue, also known as thirdhand smoke (THS), can persist in indoor environments long after tobacco has been smoked. This study examined the effects of different cleaning methods on nicotine in dust and on surfaces.
METHODS


Participants had strict indoor home smoking bans and were randomly assigned to: dry/damp cleaning followed by wet cleaning one month later (N=10), wet cleaning followed by dry/damp cleaning (N=10) one month later, and dry/damp and wet cleaning applied the same day (N=28). Nicotine on surfaces and in dust served as markers of THS and were measured before, immediately after, and 3 months after the cleaning, using liquid chromatography with triple quadrupole mass spectrometry (LC-MS/MS).
RESULTS


Over a 4-month period prior to cleaning, surface nicotine levels remained unchanged (GeoMean change: -11% to +8%; repeated measures r=0.94; p<0.001). Used separately, dry/damp and wet cleaning methods showed limited benefits. When applied in combination, however, we observed significantly reduced nicotine on surfaces and in dust. Compared to baseline, GeoMean surface nicotine was 43% lower immediately after (z=-3.73, p<0.001) and 53% lower 3 months later (z=-3.96, p<0.001). GeoMean dust nicotine loading declined by 60% immediately after (z=-3.55, p<0.001) and then increased 3 months later to precleaning levels (z=-1.18, p=0.237).
CONCLUSIONS


Cleaning interventions reduced but did not permanently remove nicotine in dust and on surfaces. Cleaning efforts for THS need to address persistent pollutant reservoirs and replenishment of reservoirs from new tobacco smoke intrusion. THS contamination in low-income homes may contribute to health disparities, particularly in children.
IMPLICATIONS


Administered sequentially or simultaneously, the tested cleaning protocols reduced nicotine on surfaces by approximately 50% immediately after and 3 months after the cleaning. Nicotine dust loading was reduced by approximately 60% immediately after cleaning, but it then rebounded to precleaning levels 3 months later. Cleaning protocols were unable to completely remove THS, and pollutants in dust were replenished from remaining pollutant reservoirs or new secondhand smoke intrusion. To achieve better outcomes, cleaning protocols should be systematically repeated to remove newly accumulated pollutants. New secondhand smoke intrusions need to be prevented, and remaining THS reservoirs should be identified, cleaned, or removed to prevent pollutants from these reservoirs to accumulate in dust and on surfaces.",2020,"Administered sequentially or simultaneously, the tested cleaning protocols reduced nicotine on surfaces by approximately 50% immediately after and 3 months after the cleaning.","['Multiunit Housing', 'Participants had strict indoor home smoking bans and were randomly assigned to']","['dry/damp cleaning followed by wet cleaning one month later (N=10), wet cleaning followed by dry/damp cleaning', 'Nicotine']","['surface nicotine levels', 'GeoMean dust nicotine loading', 'Nicotine dust loading', 'GeoMean surface nicotine']","[{'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C4505495', 'cui_str': 'Smoking Prohibition'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0205381', 'cui_str': 'Wet'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0202431', 'cui_str': 'Nicotine measurement'}, {'cui': 'C0013330', 'cui_str': 'Dust'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}]",,0.0116765,"Administered sequentially or simultaneously, the tested cleaning protocols reduced nicotine on surfaces by approximately 50% immediately after and 3 months after the cleaning.","[{'ForeName': 'Georg E', 'Initials': 'GE', 'LastName': 'Matt', 'Affiliation': 'San Diego State University Department of Psychology, San Diego, CA, U.S.A.'}, {'ForeName': 'Penelope J E', 'Initials': 'PJE', 'LastName': 'Quintana', 'Affiliation': 'San Diego State University School of Public Health, San Diego, CA, U.S.A.'}, {'ForeName': 'Eunha', 'Initials': 'E', 'LastName': 'Hoh', 'Affiliation': 'San Diego State University School of Public Health, San Diego, CA, U.S.A.'}, {'ForeName': 'Joy M', 'Initials': 'JM', 'LastName': 'Zakarian', 'Affiliation': 'San Diego State University Research Foundation, San Diego, CA, U.S.A.'}, {'ForeName': 'Nathan G', 'Initials': 'NG', 'LastName': 'Dodder', 'Affiliation': 'San Diego State University Research Foundation, San Diego, CA, U.S.A.'}, {'ForeName': 'Rachael A', 'Initials': 'RA', 'LastName': 'Record', 'Affiliation': 'San Diego State University School of Communication, San Diego, CA, U.S.A.'}, {'ForeName': 'Melbourne F', 'Initials': 'MF', 'LastName': 'Hovell', 'Affiliation': 'San Diego State University School of Public Health, San Diego, CA, U.S.A.'}, {'ForeName': 'E Melinda', 'Initials': 'EM', 'LastName': 'Mahabee-Gittens', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, U.S.A.""}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Padilla', 'Affiliation': 'San Diego State University Research Foundation, San Diego, CA, U.S.A.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Markman', 'Affiliation': 'San Diego State University School of Public Health, San Diego, CA, U.S.A.'}, {'ForeName': 'Kayo', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'San Diego State University School of Public Health, San Diego, CA, U.S.A.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Novotny', 'Affiliation': 'San Diego State University School of Public Health, San Diego, CA, U.S.A.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa151']
2197,32803280,Anchor type at upper instrumented vertebra and postoperative shoulder imbalance in patients with Lenke type 1 adolescent idiopathic scoliosis.,"PURPOSE


To clarify the impact of anchor type at upper instrumented vertebra (UIV) on postoperative shoulder imbalance in patients with Lenke type 1 adolescent idiopathic scoliosis (AIS) who underwent posterior spinal fusion.
METHODS


Subjects were 81 patients with Lenke type 1 AIS who underwent posterior spinal fusion between 2004 and 2013. Twenty-five patients agreed to participate in the study. We divided the patients into two groups: Hook group (15 patients with hooks at UIV who underwent surgery between 2004 and 2011) and PS group (ten patients with pedicle screws at UIV who underwent surgery between 2012 and 2013). To evaluate shoulder balance, first thoracic vertebra tilt angle (T1 tilt), clavicle angle (CA), and radiographic shoulder height (RSH) were measured.
RESULTS


There were no significant differences in preoperative T1 tilt, CA, or RSH between the both groups. The postoperative 1-week, 2-year, and most recently observed T1 tilts were significantly smaller in the Hook group than in the PS group. There were no significant differences in postoperative 1-week, 2-year, and most recently observed CAs between the two groups. Although there were no significant differences in 1-week postoperative RSH between the groups, the 2-year postoperative RSH was significantly smaller in the Hook group than in the PS group. The most recently observed RSH tended to be smaller in the Hook group than in the PS group, but the difference was not significant.
CONCLUSIONS


In the PS group, poor shoulder balance remained over the long term. The hooks at UIV adjusted postoperative shoulder balance.",2020,"There were no significant differences in postoperative 1-week, 2-year, and most recently observed CAs between the two groups.","['Subjects were 81 patients with Lenke type 1 AIS who underwent posterior spinal fusion between 2004 and 2013', 'patients with Lenke type 1 adolescent idiopathic scoliosis (AIS) who underwent posterior spinal fusion', '15 patients with hooks at UIV who underwent surgery between 2004 and 2011) and PS group (ten patients with pedicle screws at UIV who underwent surgery between 2012 and 2013', 'patients with Lenke type 1 adolescent idiopathic scoliosis', 'Twenty-five patients agreed to participate in the study']","['Hook group', 'anchor type at upper instrumented vertebra (UIV']","['postoperative shoulder imbalance', 'preoperative T1 tilt, CA, or RSH', '1-week postoperative RSH', 'shoulder balance, first thoracic vertebra tilt angle (T1 tilt), clavicle angle (CA), and radiographic shoulder height (RSH', 'T1 tilts', '2-year postoperative RSH', 'poor shoulder balance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0410702', 'cui_str': 'Adolescent idiopathic scoliosis'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0181209', 'cui_str': 'Hook'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0181209', 'cui_str': 'Hook'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0039987', 'cui_str': 'Bone structure of thoracic vertebra'}, {'cui': 'C0454235', 'cui_str': 'Tilt angle'}, {'cui': 'C0008913', 'cui_str': 'Bone structure of clavicle'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0459933', 'cui_str': 'Bone structure of T1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",81.0,0.01757,"There were no significant differences in postoperative 1-week, 2-year, and most recently observed CAs between the two groups.","[{'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Akazawa', 'Affiliation': 'Department of Orthopaedic Surgery, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, 216-8511, Kawasaki, Kanagawa, Japan. cds00350@par.odn.ne.jp.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Kuroya', 'Affiliation': 'Department of Orthopaedic Surgery, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, 216-8511, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Kotani', 'Affiliation': 'Department of Orthopedic Surgery, Seirei Sakura Citizen Hospital, Sakura, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Sakuma', 'Affiliation': 'Department of Orthopedic Surgery, Seirei Sakura Citizen Hospital, Sakura, Japan.'}, {'ForeName': 'Keita', 'Initials': 'K', 'LastName': 'Nakayama', 'Affiliation': 'Department of Orthopedic Surgery, Seirei Sakura Citizen Hospital, Sakura, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Iijima', 'Affiliation': 'Department of Orthopedic Surgery, Seirei Sakura Citizen Hospital, Sakura, Japan.'}, {'ForeName': 'Yoshiaki', 'Initials': 'Y', 'LastName': 'Torii', 'Affiliation': 'Department of Orthopaedic Surgery, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, 216-8511, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Iinuma', 'Affiliation': 'Department of Orthopaedic Surgery, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, 216-8511, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Kota', 'Initials': 'K', 'LastName': 'Asano', 'Affiliation': 'Department of Orthopaedic Surgery, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, 216-8511, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ueno', 'Affiliation': 'Department of Orthopaedic Surgery, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, 216-8511, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Atsuhiro', 'Initials': 'A', 'LastName': 'Yoshida', 'Affiliation': 'Department of Orthopaedic Surgery, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, 216-8511, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Murakami', 'Affiliation': 'Department of Orthopaedic Surgery, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, 216-8511, Kawasaki, Kanagawa, Japan.'}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Minami', 'Affiliation': 'Department of Orthopedic Surgery, Seirei Sakura Citizen Hospital, Sakura, Japan.'}, {'ForeName': 'Sumihisa', 'Initials': 'S', 'LastName': 'Orita', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Inage', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Shiga', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Nakamura', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'Inoue', 'Affiliation': 'Department of Orthopaedic Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Miyagi', 'Affiliation': 'Department of Orthopaedic Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Saito', 'Affiliation': 'Department of Orthopaedic Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Yawara', 'Initials': 'Y', 'LastName': 'Eguchi', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Orthopaedic Surgery, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Ohtori', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Hisateru', 'Initials': 'H', 'LastName': 'Niki', 'Affiliation': 'Department of Orthopaedic Surgery, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, 216-8511, Kawasaki, Kanagawa, Japan.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-020-02766-4']
2198,32803294,Effects of N-acetylcysteine inhalation therapy on the quality of life of patients with head and neck cancer who are receiving radiation therapy: a prospective non-randomized controlled multi-center study.,"BACKGROUNDS AND PURPOSE


Radiation therapy is an important mode of treatment for patients with head and neck cancers, but some associated complications can reduce the quality of life. We investigated whether N-acetylcysteine inhalation therapy improved the quality of life of such patients.
MATERIALS AND METHODS


We designed a prospective, non-randomized controlled multi-center study involving 10 institutions. We enrolled 120 patients (80 in the experimental group and 40 in the control group). Patients in the experimental group inhaled nebulized liquid N-acetylcysteine (2400 mg daily) for 8 weeks from the start of radiation therapy. Quality of life was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire H&N 35.
RESULTS


N-acetylcysteine inhalation was not associated with any side effect or discomfort. The reduction in painkiller use from the end of N-acetylcysteine inhalation therapy to the 1-month follow-up was greater in the experimental group than in the control group (P = 0.014). Dry mouth symptoms also improved significantly in the experimental group (P = 0.019).
CONCLUSION


N-acetylcysteine inhalation improves the quality of life of patients with head and neck cancers who are receiving radiation therapy, without any specific side effect.",2020,"Dry mouth symptoms also improved significantly in the experimental group (P = 0.019).
","['patients with head and neck cancer who are receiving', '10 institutions', 'We enrolled 120 patients (80 in the experimental group and 40 in the control group', 'patients with head and neck cancers']","['nebulized liquid N-acetylcysteine', 'N-acetylcysteine inhalation', 'N-acetylcysteine inhalation therapy', 'radiation therapy']","['quality of life', 'side effect or discomfort', 'Dry mouth symptoms', 'Quality of life', 'quality of life of such patients']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0021459', 'cui_str': 'Inhalation therapy procedure'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",120.0,0.0246669,"Dry mouth symptoms also improved significantly in the experimental group (P = 0.019).
","[{'ForeName': 'Ho-Ryun', 'Initials': 'HR', 'LastName': 'Won', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Chungnam National University College of Medicine, 640 Daesa-Dong, Chung-Gu, Daejeon, 301-721, Republic of Korea.'}, {'ForeName': 'Geon Ho', 'Initials': 'GH', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Chungnam National University College of Medicine, 640 Daesa-Dong, Chung-Gu, Daejeon, 301-721, Republic of Korea.'}, {'ForeName': 'Jin Hwan', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Kangnam Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Hyuk', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Soon Young', 'Initials': 'SY', 'LastName': 'Kwon', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Korea University Ansan Hospital, College of Medicine, Ansan, Republic of Korea.'}, {'ForeName': 'Seung-Kuk', 'Initials': 'SK', 'LastName': 'Baek', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chang Hwan', 'Initials': 'CH', 'LastName': 'Ryu', 'Affiliation': 'Department of Otorhinolaryngology, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Sang Joon', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Dankook University College of Medicine, 201 Manghyang-ro Dongnam-gu, Cheonan, 31116, Republic of Korea.'}, {'ForeName': 'Il-Seok', 'Initials': 'IS', 'LastName': 'Park', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Sung-Chan', 'Initials': 'SC', 'LastName': 'Shin', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Dong Wook', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Chungbuk National University College of Medicine, Chungbuk National University Hospital, Cheongju, Republic of Korea.'}, {'ForeName': 'Phil-Sang', 'Initials': 'PS', 'LastName': 'Chung', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Dankook University College of Medicine, 201 Manghyang-ro Dongnam-gu, Cheonan, 31116, Republic of Korea. pschung@dankook.ac.kr.'}, {'ForeName': 'Bon Seok', 'Initials': 'BS', 'LastName': 'Koo', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, Chungnam National University College of Medicine, 640 Daesa-Dong, Chung-Gu, Daejeon, 301-721, Republic of Korea. bskoo515@cnuh.co.kr.'}]",Journal of cancer research and clinical oncology,['10.1007/s00432-020-03347-y']
2199,32803412,Effect of 2 years of calorie restriction on liver biomarkers: results from the CALERIE phase 2 randomized controlled trial.,"PURPOSE


Calorie restriction (CR) is an effective treatment for obesity-related liver and metabolic disease. However, CR studies in individuals without obesity are needed to see if CR could delay disease onset. Liver biomarkers indicate hepatic health and are linked to cardiometabolic disease. Our aim was to examine the effects of a 2-year CR intervention on liver biomarkers in healthy individuals without obesity.
METHODS


The Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy (CALERIE) study was a 2-year randomized controlled trial. Overall, 218 participants (body mass index: 25.1 ± 1.7 kg/m 2 ) were enrolled into a control group (n = 75) that ate ad libitum (AL), or a CR group (n = 143) that aimed to decrease energy intake by 25%. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), and bilirubin were measured during the trial.
RESULTS


At month 24, relative to the AL group, ALP (- 7 ± 1 IU/L; P < 0.01) and GGT (- 0.11 ± 0.04 log IU/L; P = 0.02) decreased and bilirubin increased (0.21 ± 0.06 log mg/dL; P < 0.01) in the CR group; no between-group differences in ALT (- 1 ± 1 IU/L; P > 0.99) or AST (2 ± 2 IU/L; P = 0.68) were revealed. However, sex-by-treatment-by-time interactions (P < 0.01) were observed, with CR (vs. control) inducing reduced ALT and GGT and increased AST in men only (P ≤ 0.02).
CONCLUSIONS


In metabolically healthy individuals without obesity, 2 years of CR improves several liver biomarkers, with potentially greater improvements in men. These data suggest that sustained CR may improve long-term liver and metabolic disease risk in healthy adults.
TRIAL REGISTRATION


Clinicaltrials.gov (NCT00427193). Registered January 2007.",2020,"At month 24, relative to the AL group, ALP (- 7 ± 1 IU/L; P < 0.01) and GGT (- 0.11 ± 0.04 log IU/L; P = 0.02) decreased and bilirubin increased (0.21 ± 0.06 log mg/dL; P < 0.01) in the CR group; no between-group differences in ALT (- 1 ± 1 IU/L; P > 0.99) or AST (2 ± 2 IU/L; P = 0.68) were revealed.","['218 participants (body mass index: 25.1\u2009±\u20091.7\xa0kg/m 2 ', 'healthy adults', 'healthy individuals without obesity', 'individuals without obesity']","['Calorie restriction (CR', 'CR intervention', 'calorie restriction']","['Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), and bilirubin', 'bilirubin', 'reduced ALT and GGT and increased AST', 'liver biomarkers']","[{'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517512', 'cui_str': '1.7'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.110205,"At month 24, relative to the AL group, ALP (- 7 ± 1 IU/L; P < 0.01) and GGT (- 0.11 ± 0.04 log IU/L; P = 0.02) decreased and bilirubin increased (0.21 ± 0.06 log mg/dL; P < 0.01) in the CR group; no between-group differences in ALT (- 1 ± 1 IU/L; P > 0.99) or AST (2 ± 2 IU/L; P = 0.68) were revealed.","[{'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Dorling', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd., Baton Rouge, LA, 70808, USA. jdorling326@gmail.com.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ravussin', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd., Baton Rouge, LA, 70808, USA.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Redman', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd., Baton Rouge, LA, 70808, USA.'}, {'ForeName': 'Manju', 'Initials': 'M', 'LastName': 'Bhapkar', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Huffman', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Racette', 'Affiliation': 'Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Sai K', 'Initials': 'SK', 'LastName': 'Das', 'Affiliation': 'JM, USDA, Human Nutrition Research Center on Aging at Tufts University, Boston, MA, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Apolzan', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd., Baton Rouge, LA, 70808, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Höchsmann', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd., Baton Rouge, LA, 70808, USA.'}, {'ForeName': 'Corby K', 'Initials': 'CK', 'LastName': 'Martin', 'Affiliation': 'Pennington Biomedical Research Center, 6400 Perkins Rd., Baton Rouge, LA, 70808, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of nutrition,['10.1007/s00394-020-02361-7']
2200,32803728,Effects of Good Pain Management (GPM) ward program on patterns of care and pain control in patients with cancer pain in Taiwan.,"BACKGROUND


The undertreatment of cancer pain is a global issue although many international guidelines and various studies bloom to explore the approaches in pain management. However, there is no standard care for cancer pain in routine practices. To set up a standardized procedure for improving cancer pain management in Taiwan, the Good Pain Management (GPM) program is explored to provide treatments following the US National Cancer Care Network (NCCN) Adult Cancer Pain Guideline.
METHOD


Patients diagnosed with moderate-to-severe cancer pain were eligible and randomized into the GPM or control arm and observed the first 48 h to evaluate the effects of pain management between 2 arms. Pain control, adequacy of treatments, patient satisfaction, and quality of life (QoL) of eligible patients were analyzed. Ad hoc analyses based on the pain medication category were also conducted.
RESULT


Fifty-one patients were enrolled, with 26 and 25 assigned to the GPM and control arms, respectively. Significant differences among the GPM and control arms were found including a greater decrease in the mean numerical rating scale (NRS) score in the GPM arm (- 4.6 vs. - 2.8), a lower proportion of moderate-to-severe pain in the GPM arm (23.2% vs. 39.8%), and a higher pain management index (PMI) score in the GPM arm (0.64 points vs. 0.33 points) (all p < 0.05). Ad hoc analyses revealed that the patient subgroups using strong opioids showed better patient satisfaction in GPM arm when compared with the same subgroup in the control arm.
CONCLUSION


In summary, our study demonstrated that the implementation of a standardized pain assessment and management approach (GPM ward program) showed significant improvements on pain relief, decreased the portion of moderate-to-severe cancer pain, and increased patient satisfaction in the 1st 48 h after admission. The implementation of the GPM approach in the cancer ward may provide sooner and better improvement of cancer pain management for patients who suffered moderate-to-severe cancer pain.
TRIAL REGISTRATION


ClinicalTrials.gov (Identifier: NCT03155516).",2020,"Significant differences among the GPM and control arms were found including a greater decrease in the mean numerical rating scale (NRS) score in the GPM arm (- 4.6 vs. - 2.8), a lower proportion of moderate-to-severe pain in the GPM arm (23.2% vs. 39.8%), and a higher pain management index (PMI) score in the GPM arm (0.64 points vs. 0.33 points) (all p < 0.05).","['Fifty-one patients were enrolled, with 26 and 25 assigned to the GPM and control arms, respectively', 'Patients diagnosed with moderate-to-severe cancer pain', 'patients who suffered moderate-to-severe cancer pain', 'Adult Cancer Pain Guideline', 'cancer pain management in Taiwan, the Good Pain Management (GPM) program', 'patients with cancer pain in Taiwan']","['Good Pain Management (GPM) ward program', 'GPM']","['higher pain management index (PMI) score', 'pain relief', 'portion of moderate-to-severe cancer pain', 'pain management', 'patient satisfaction', 'Pain control, adequacy of treatments, patient satisfaction, and quality of life (QoL', 'cancer pain management', 'mean numerical rating scale (NRS) score', 'moderate-to-severe pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",51.0,0.0271338,"Significant differences among the GPM and control arms were found including a greater decrease in the mean numerical rating scale (NRS) score in the GPM arm (- 4.6 vs. - 2.8), a lower proportion of moderate-to-severe pain in the GPM arm (23.2% vs. 39.8%), and a higher pain management index (PMI) score in the GPM arm (0.64 points vs. 0.33 points) (all p < 0.05).","[{'ForeName': 'Wei-Chih', 'Initials': 'WC', 'LastName': 'Su', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100 Tzyou 1st Road, Kaohsiung, 807, Taiwan.'}, {'ForeName': 'Chieh-Han', 'Initials': 'CH', 'LastName': 'Chuang', 'Affiliation': 'Department of Surgery and ICU, Kaohsiung Municipal Siaogang Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Fang-Ming', 'Initials': 'FM', 'LastName': 'Chen', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Hsiang-Lin', 'Initials': 'HL', 'LastName': 'Tsai', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100 Tzyou 1st Road, Kaohsiung, 807, Taiwan.'}, {'ForeName': 'Ching-Wen', 'Initials': 'CW', 'LastName': 'Huang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100 Tzyou 1st Road, Kaohsiung, 807, Taiwan.'}, {'ForeName': 'Tsung-Kun', 'Initials': 'TK', 'LastName': 'Chang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100 Tzyou 1st Road, Kaohsiung, 807, Taiwan.'}, {'ForeName': 'Ming-Feng', 'Initials': 'MF', 'LastName': 'Hou', 'Affiliation': 'Division of Breast Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.'}, {'ForeName': 'Jaw-Yuan', 'Initials': 'JY', 'LastName': 'Wang', 'Affiliation': 'Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, No. 100 Tzyou 1st Road, Kaohsiung, 807, Taiwan. cy614112@ms14.hinet.net.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05656-x']
2201,32803791,Intra-operative methadone effect on quality of recovery compared with morphine following laparoscopic gastroplasty: a randomised controlled trial.,"The effect of intra-operative intravenous methadone on quality of postoperative recovery was compared with morphine after laparoscopic gastroplasty. We included 137 adult patients with a body mass index > 35 kg.m -2  who underwent bariatric surgery. Patients were allocated at random to receive either intra-operative methadone (n = 69) or morphine (n = 68). All patients received the same postoperative care and analgesia. The primary outcome of postoperative quality of recovery was assessed using the Quality of Recovery-40 questionnaire total score 24 h after surgery. Secondary outcomes were assessed in the post-anaesthesia care unit the night of the day of surgery (T1), in the morning after surgery (T2); and at night on the day following surgery (T3). The median (IQR [range]) total Quality of Recovery-40 questionnaire score of 194 (190-197 [165-200]) was higher (p < 0.0001) in the methadone group compared with the score of 181 (174-185.5 [121-200]) in the morphine group. In the post-anaesthesia care unit, the pain burden; incidence of nausea and vomiting; rescue morphine dose; and time to discharge, were significantly lower in the methadone group. On the ward, the methadone group had a lower: incidence of rescue morphine requests at T1 (5.8 vs. 54.4%, p < 0.0001) and T2 (0 vs. 20.1%, p < 0.0001); and incidence of nausea (21.7 vs. 41.2%, p = 0.014), compared with the morphine group. We conclude that intra-operative intravenous methadone improved quality of recovery in patients who underwent laparoscopic gastroplasty, compared with intra-operative morphine. Methadone also reduced postoperative pain, postoperative opioid consumption and the incidence of opioid-related adverse events.",2020,p < 0.0001) in the methadone group compared with the score of 181 (174-185.5 [121-200]) in the morphine group.,"['137 adult patients with a body mass index ', '35', 'laparoscopic gastroplasty']","['bariatric surgery', 'methadone', 'intra-operative methadone', 'Methadone', 'morphine ', 'morphine']","['lower: incidence of rescue morphine requests', 'postoperative pain, postoperative opioid consumption and the incidence of opioid-related adverse events', 'nausea and vomiting', 'Quality of Recovery-40 questionnaire total score 24\xa0h after surgery', 'incidence of nausea', 'median (IQR [range]) total Quality of Recovery-40 questionnaire score', 'postoperative quality of recovery', 'post-anaesthesia care unit the night of the day of surgery (T1), in the morning after surgery (T2); and at night on the day following surgery (T3', 'quality of postoperative recovery', 'quality of recovery']","[{'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0017193', 'cui_str': 'Gastroplasty'}]","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]",137.0,0.3376,p < 0.0001) in the methadone group compared with the score of 181 (174-185.5 [121-200]) in the morphine group.,"[{'ForeName': 'J P J', 'Initials': 'JPJ', 'LastName': 'Pontes', 'Affiliation': 'Department of Anaesthesiology, Santa Genoveva Hospital Complex, Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'F R', 'Initials': 'FR', 'LastName': 'Braz', 'Affiliation': 'Department of Anaesthesiology, Santa Genoveva Hospital Complex, Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'N S P', 'Initials': 'NSP', 'LastName': 'Módolo', 'Affiliation': 'Botucatu School of Medicine, UNESP, São Paulo, Brazil.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Mattar', 'Affiliation': 'Department of Surgery, Santa Genoveva Hospital Complex, Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'J A G', 'Initials': 'JAG', 'LastName': 'Sousa', 'Affiliation': 'Department of Surgery, Santa Genoveva Hospital Complex, Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Navarro E Lima', 'Affiliation': 'Department of Anaesthesia, Queens University, Kingston, ON, Canada.'}]",Anaesthesia,['10.1111/anae.15173']
2202,32803798,Surgical treatment of peri-implantitis defects with two different xenograft granules- A randomized clinical pilot study.,"OBJECTIVES


To investigate whether xenograft EB (EndoBon) is non-inferior to xenograft BO (BioOss) when used in reconstructive surgery of peri-implant osseous defects.
MATERIALS AND METHODS


Dental patients with one implant each, demonstrating peri-implantitis were randomized to receive surgical debridement and defect with either BO or EB. Changes in bone level (BL) and intrabony defect depth (IDD) evaluated radiographically were the primary outcomes. The secondary outcomes included changes in probing pocket depth (PPD), bleeding on probing (BoP) and suppuration on probing (SoP). All outcomes were recorded before treatment and at 6 and 12 months post-treatment.
RESULTS


Twenty-four patients (n=11 BO, n=13 EB) completed the study. Both groups demonstrated significant within-group improvements in all clinical and radiographic parameters at 6 and 12 months (p≤0.001). At 12 months, both groups presented with IDD reductions of 2.5-3.0 mm on average. The inter-group differences were not statistically significant at all time points and for all the examined parameters (p>0.05). While the radiographic defect fill in both groups exceeded >1 mm and can be considered treatment success, successful treatment outcomes as defined by Consensus Reporting (no further bone loss, PPD ≤5 mm, no BOP, and no SoP) was identified in 2/11 (18%) BO, and 0/13 (0%) EB individuals (Fisher's exact test, p=0.199).
CONCLUSIONS


Within the limitations of this pilot study, the application of xenograft EB showed to be non-inferior to xenograft BO when used in reconstructive surgery of peri-implant osseous defects.",2020,Both groups demonstrated significant within-group improvements in all clinical and radiographic parameters at 6 and 12 months (p≤0.001).,"['Dental patients with one implant each, demonstrating peri-implantitis', 'Twenty-four patients (n=11 BO, n=13 EB) completed the study']","['xenograft EB (EndoBon', 'surgical debridement and defect with either BO or EB', 'xenograft EB']","['bone level (BL) and intrabony defect depth (IDD) evaluated radiographically', 'bone loss, PPD ≤5 mm, no BOP, and no SoP', 'changes in probing pocket depth (PPD), bleeding on probing (BoP) and suppuration on probing (SoP', 'clinical and radiographic parameters', 'IDD reductions', 'radiographic defect fill']","[{'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C2936258', 'cui_str': 'Dental peri-implantitis'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0535594', 'cui_str': 'endobon'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0038862', 'cui_str': 'Suppurative inflammation'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",24.0,0.0409807,Both groups demonstrated significant within-group improvements in all clinical and radiographic parameters at 6 and 12 months (p≤0.001).,"[{'ForeName': 'Angeliki', 'Initials': 'A', 'LastName': 'Polymeri', 'Affiliation': 'Department of Periodontology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Anssari-Moin', 'Affiliation': 'Department of Periodontology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'van der Horst', 'Affiliation': 'Department Oral Implantology and Prosthodontics, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wismeijer', 'Affiliation': 'Department Oral Implantology and Prosthodontics, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Marja L', 'Initials': 'ML', 'LastName': 'Laine', 'Affiliation': 'Department of Periodontology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Bruno G', 'Initials': 'BG', 'LastName': 'Loos', 'Affiliation': 'Department of Periodontology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit, Amsterdam, Netherlands.'}]",Clinical oral implants research,['10.1111/clr.13651']
2203,32803815,Efficacy of the Managing Cancer and Living Meaningfully (CALM) individual psychotherapy for patients with advanced cancer: A single-blind randomized controlled trial.,"OBJECTIVE


We aimed to determine whether the Managing Cancer and Living Meaningfully (CALM) therapy is superior to a non-manualized supportive psycho-oncological counselling intervention (SPI).
METHODS


Adult patients with advanced cancer and ≥ 9 points on the PHQ-9 and/or ≥ 5 points on the DT were randomized to CALM or SPI. We hypothesized that CALM patients would report significantly less depression (primary outcome) on the BDI-II and the PHQ-9 six months after baseline compared to SPI patients.
RESULTS


From 329 eligible patients, 206 participated (61.2% female; age: M = 57.9 [SD = 11.7]; 84.5% UICC IV stage). Of them, 99 were assigned to CALM and 107 to SPI. Intention-to-treat analyses revealed significantly less depressive symptoms at six months than at baseline (P < .001 for BDI-II and PHQ-9), but participants in the CALM and SPI group did not differ in depression severity (BDI-II: P = .62, PHQ-9: P = .998). Group differences on secondary outcomes were statistically not significant either.
CONCLUSIONS


CALM therapy was associated with reduction in depressive symptoms over time but this improvement was not statistically significant different than that obtained within SPI group. This article is protected by copyright. All rights reserved.",2020,"CONCLUSIONS


CALM therapy was associated with reduction in depressive symptoms over time but this improvement was not statistically significant different than that obtained within SPI group.","['age', '329 eligible patients, 206 participated (61.2% female', 'Adult patients with advanced cancer and\u2009≥\u20099 points on the', 'patients with advanced cancer']","['CALM', 'Managing Cancer and Living Meaningfully (CALM) therapy', 'Managing Cancer and Living Meaningfully (CALM) individual psychotherapy', 'PHQ-9']","['depression severity', 'depressive symptoms', 'BDI-II and the PHQ-9 six months']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517833', 'cui_str': '61.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0204525', 'cui_str': 'Individual psychotherapy'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C4082120', 'cui_str': 'Six months'}]",329.0,0.224475,"CONCLUSIONS


CALM therapy was associated with reduction in depressive symptoms over time but this improvement was not statistically significant different than that obtained within SPI group.","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Mehnert', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig, Philipp-Rosenthal-Strasse 55, Leipzig, Germany.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Koranyi', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig, Philipp-Rosenthal-Strasse 55, Leipzig, Germany.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Philipp', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Scheffold', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, Germany.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Lehmann-Laue', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig, Philipp-Rosenthal-Strasse 55, Leipzig, Germany.'}, {'ForeName': 'Dorit', 'Initials': 'D', 'LastName': 'Engelmann', 'Affiliation': 'Department of Medical Psychology and Medical Sociology, University Medical Center Leipzig, Philipp-Rosenthal-Strasse 55, Leipzig, Germany.'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Vehling', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Eisenecker', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Oechsle', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with section of Pneumology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schulz-Kindermann', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, Germany.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Rodin', 'Affiliation': 'Department of Supportive Care, 16-724, Princess Margaret Cancer Centre, Toronto, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg, Germany.'}]",Psycho-oncology,['10.1002/pon.5521']
2204,32803820,Short Message Service (SMS) reminders reduce outpatient colonoscopy nonattendance rate - a randomized controlled study.,"BACKGROUND AND AIM


Nonattendance of outpatient colonoscopy leads to inefficient use of healthcare resources. We aimed to study the effectiveness of using Short Message Service (SMS) reminder prior in patients scheduled for outpatient colonoscopy on their nonattendance rate.
METHODS


Patients who scheduled for an outpatient colonoscopy and had access of SMS were recruited from three clinics in Hong Kong. Patients were randomized to SMS group and standard care group (SC). All patients were given a written appointment slip on the booking date. In addition, patients in SMS group received a SMS reminder 7 - 10 days prior to their colonoscopy appointment. Patients' demographics, attendance, colonoscopy completion and bowel preparation quality were recorded. Logistic regression was performed to identify predictors of nonattendance.
RESULTS


From November 2013 to October 2019, a total of 2225 eligible patients were recruited. 1079 patients were allocated to SMS group and 1146 to SC group. The nonattendance rate of patients in SMS group was significantly lower than that in SC group (8.9% vs 11.9%, p=0.022). There were no significant differences in their baseline characteristics and colonoscopy completion rate and bowel preparation quality. A trend toward a higher rate of adequate bowel preparation was observed in the SMS group when compared with SC group (69.9% vs. 65.8%, p=0.053). Independent predictors for nonattendance included younger age, underprivilege and existing diabetes.
CONCLUSIONS


A SMS reminder for outpatient colonoscopy is effective in reducing the nonattendance rate and may potentially improve the bowel preparation quality.",2020,There were no significant differences in their baseline characteristics and colonoscopy completion rate and bowel preparation quality.,"['patients scheduled for outpatient colonoscopy on their nonattendance rate', '1079 patients', 'From November 2013 to October 2019, a total of 2225 eligible patients were recruited', 'Patients who scheduled for an outpatient colonoscopy and had access of SMS were recruited from three clinics in Hong Kong']","['SMS', 'Short Message Service (SMS) reminder prior', 'Short Message Service (SMS) reminders', 'SMS group and standard care group (SC']","['nonattendance rate', 'colonoscopy completion rate and bowel preparation quality', 'rate of adequate bowel preparation', ""Patients' demographics, attendance, colonoscopy completion and bowel preparation quality""]","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",2225.0,0.111367,There were no significant differences in their baseline characteristics and colonoscopy completion rate and bowel preparation quality.,"[{'ForeName': 'Thomas Yt', 'Initials': 'TY', 'LastName': 'Lam', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Aric J', 'Initials': 'AJ', 'LastName': 'Hui', 'Affiliation': 'Department of Medicine, Alice Ho Miu Ling Nethersole Hospital, Hong Kong.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Sia', 'Affiliation': 'Department of Medicine, Alice Ho Miu Ling Nethersole Hospital, Hong Kong.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Wong', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, Hong Kong.'}, {'ForeName': 'Casper Cp', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Wong Siu Ching Family Medicine Centre, Hong Kong.'}, {'ForeName': 'K W', 'Initials': 'KW', 'LastName': 'Chung', 'Affiliation': 'Wong Siu Ching Family Medicine Centre, Hong Kong.'}, {'ForeName': 'James Yw', 'Initials': 'JY', 'LastName': 'Lau', 'Affiliation': 'Department of Surgery, Prince of Wales Hospital, Hong Kong.'}, {'ForeName': 'Peter I', 'Initials': 'PI', 'LastName': 'Wu', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Joseph Jy', 'Initials': 'JJ', 'LastName': 'Sung', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong.'}]",Journal of gastroenterology and hepatology,['10.1111/jgh.15218']
2205,32803824,Interoceptive signaling in alcohol cognitive biases: Role of family history and alliesthetic components.,"The role of interoceptive signals in the development of cognitive biases for drug-related cues has been hypothesized in the past; however, experimental evidence is lacking. This report examined the relationship between physiological responses and memories for alcohol cues. Participants (n = 158) were categorized as having either a positive or negative family history of alcohol use disorder (AUD). They were assigned to an alcohol, placebo, or control beverage condition to which they were blinded. All participants were presented with alcohol, neutral, and emotional cues. Heart rate variability (HRV) at 0.1 Hz, as an index of viscero-afferent reactivity, and in the high-frequency range was measured during picture-cue exposure. Participants then completed free recall and repetition priming tasks to assess memories for previously presented stimuli. Participants with a positive family history (FHP) for AUD who received an alcohol beverage displayed a positive relationship between 0.1 Hz HRV and free recall. This effect was specific to alcohol cues, highlighting the relevance of physiological signals in the development of alcohol cognitive biases. These results support the hypothesis of a coordinated brain-body interaction in the development of drug-related behaviors. FHP as an AUD risk factor may increase the mapping of physiological responses onto cognitive biases for alcohol cues. Increased ratings of subjective intoxication dampened this relationship, suggesting that perceived bodily states may modulate incentive salience processes. This report provides novel evidence for the involvement of interoceptive signals in addictive processes, setting a precedent for the exploration of brain-body interactions in the study of alcohol cognitive biases.",2020,Participants with a positive family history (FHP) for AUD who received an alcohol beverage displayed a positive relationship between 0.1 Hz HRV and free recall.,"['Participants with a positive family history (FHP) for AUD who received an', 'Participants (n = 158) were categorized as having either a positive or negative family history of alcohol use disorder (AUD', 'All participants were presented with alcohol, neutral, and emotional cues']","['alcohol, placebo', 'alcohol beverage']",['Heart rate variability (HRV'],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0241889', 'cui_str': 'Family history of clinical finding'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0476560', 'cui_str': 'Family history of alcohol abuse'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}]",158.0,0.0457924,Participants with a positive family history (FHP) for AUD who received an alcohol beverage displayed a positive relationship between 0.1 Hz HRV and free recall.,"[{'ForeName': 'Mateo', 'Initials': 'M', 'LastName': 'Leganes-Fonteneau', 'Affiliation': 'Department of Kinesiology and Health, Rutgers University-New Brunswick, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Buckman', 'Affiliation': 'Department of Kinesiology and Health, Rutgers University-New Brunswick, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Pawlak', 'Affiliation': 'Department of Kinesiology and Health, Rutgers University-New Brunswick, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Bronya', 'Initials': 'B', 'LastName': 'Vaschillo', 'Affiliation': 'Department of Kinesiology and Health, Rutgers University-New Brunswick, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Vaschillo', 'Affiliation': 'Department of Kinesiology and Health, Rutgers University-New Brunswick, New Brunswick, New Jersey, USA.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Bates', 'Affiliation': 'Department of Kinesiology and Health, Rutgers University-New Brunswick, New Brunswick, New Jersey, USA.'}]",Addiction biology,['10.1111/adb.12952']
2206,32803882,Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients.,"BACKGROUND


Kidney transplantation is the preferred management for patients with end-stage kidney disease (ESKD). However, it is often complicated by worsening or new-onset diabetes. The safety and efficacy of glucose-lowering agents after kidney transplantation is largely unknown. This is an update of a review first published in 2017.
OBJECTIVES


To evaluate the efficacy and safety of glucose-lowering agents for treating pre-existing and new onset diabetes in people who have undergone kidney transplantation.
SEARCH METHODS


We searched the Cochrane Kidney and Transplant Register of Studies up to 16 January 2020 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.
SELECTION CRITERIA


All randomised controlled trials (RCTs), quasi-RCTs and cross-over studies examining head-to-head comparisons of active regimens of glucose-lowering therapy or active regimen compared with placebo/standard care in patients who have received a kidney transplant and have diabetes were eligible for inclusion.
DATA COLLECTION AND ANALYSIS


Four authors independently assessed study eligibility and quality and performed data extraction. Continuous outcomes were expressed as post-treatment mean differences (MD) or standardised mean difference (SMD). Adverse events were expressed as post-treatment absolute risk differences (RD). Dichotomous clinical outcomes were presented as risk ratios (RR) with 95% confidence intervals (CI).
MAIN RESULTS


Ten studies (21 records, 603 randomised participants) were included - three additional studies (five records) since our last review. Four studies compared more intensive versus less intensive insulin therapy; two studies compared dipeptidyl peptidase-4 (DPP-4) inhibitors to placebo; one study compared DPP-4 inhibitors to insulin glargine; one study compared sodium glucose co-transporter 2 (SGLT2) inhibitors to placebo; and two studies compared glitazones and insulin to insulin therapy alone. The majority of studies had an unclear to a high risk of bias. There were no studies examining the effects of biguanides, glinides, GLP-1 agonists, or sulphonylureas. Compared to less intensive insulin therapy, it is unclear if more intensive insulin therapy has an effect on transplant or graft survival (4 studies, 301 participants: RR 1.12, 95% CI 0.32 to 3.94; I 2  = 49%; very low certainty evidence), delayed graft function (2 studies, 153 participants: RR 0.63, 0.42 to 0.93; I 2  = 0%; very low certainty evidence), HbA1c (1 study, 16 participants; very low certainty evidence), fasting blood glucose (1 study, 24 participants; very low certainty evidence), kidney function markers (1 study, 26 participants; very low certainty evidence), death (any cause) (3 studies, 208 participants"" RR 0.68, 0.29 to 1.58; I 2  = 0%; very low certainty evidence), hypoglycaemia (4 studies, 301 participants; very low certainty evidence) and medication discontinuation due to adverse effects (1 study, 60 participants; very low certainty evidence). Compared to placebo, it is unclear whether DPP-4 inhibitors have an effect on hypoglycaemia and medication discontinuation (2 studies, 51 participants; very low certainty evidence). However, DPP-4 inhibitors may reduce HbA1c and fasting blood glucose but not kidney function markers (1 study, 32 participants; low certainty evidence). Compared to insulin glargine, it is unclear if DPP-4 inhibitors have an effect on HbA1c, fasting blood glucose, hypoglycaemia or discontinuation due to adverse events (1 study, 45 participants; very low certainty evidence). Compared to placebo, SGLT2 inhibitors probably do not affect kidney graft survival (1 study, 44 participants; moderate certainty evidence), but may reduce HbA1c without affecting fasting blood glucose and eGFR long-term (1 study, 44 participants, low certainty evidence). SGLT2 inhibitors probably do not increase hypoglycaemia, and probably have little or no effect on medication discontinuation due to adverse events. However, all participants discontinuing SGLT2 inhibitors had urinary tract infections (1 study, 44 participants, moderate certainty evidence). Compared to insulin therapy alone, it is unclear if glitazones added to insulin have an effect on HbA1c or kidney function markers (1 study, 62 participants; very low certainty evidence). However, glitazones may make little or no difference to fasting blood glucose (2 studies, 120 participants; low certainty evidence), and medication discontinuation due to adverse events (1 study, 62 participants; low certainty evidence). No studies of DPP-4 inhibitors, or glitazones reported effects on transplant or graft survival, delayed graft function or death (any cause).
AUTHORS' CONCLUSIONS


The efficacy and safety of glucose-lowering agents in the treatment of pre-existing and new-onset diabetes in kidney transplant recipients is questionable. Evidence from existing studies examining the effect of intensive insulin therapy, DPP-4 inhibitors, SGLT inhibitors and glitazones is mostly of low to very low certainty. Appropriately blinded, larger, and higher quality RCTs are needed to evaluate and compare the safety and efficacy of contemporary glucose-lowering agents in the kidney transplant population.",2020,"Compared to less intensive insulin therapy, it is unclear if more intensive insulin therapy has an effect on transplant or graft survival (4 studies, 301 participants: RR 1.12, 95% CI 0.32 to 3.94; I 2  = 49%; very low certainty evidence), delayed graft function (2 studies, 153 participants: RR 0.63, 0.42 to 0.93; I 2  = 0%; very low certainty evidence), HbA1c (1 study, 16 participants; very low certainty evidence), fasting blood glucose (1 study, 24 participants; very low certainty evidence), kidney function markers (1 study, 26 participants; very low certainty evidence), death (any cause) (3 studies, 208 participants"" RR 0.68, 0.29 to 1.58; I 2  = 0%; very low certainty evidence), hypoglycaemia (4 studies, 301 participants; very low certainty evidence) and medication discontinuation due to adverse effects (1 study, 60 participants; very low certainty evidence).","['kidney transplant recipients', 'patients who have received a kidney transplant and have diabetes were eligible for inclusion', 'people who have undergone kidney transplantation', 'Ten studies (21 records, 603 randomised participants) were included - three additional studies (five records) since our last review', 'patients with end-stage kidney disease (ESKD', 'kidney transplant population']","['glucose-lowering therapy or active regimen', 'Glucose-lowering agents', 'DPP-4 inhibitors', 'placebo, SGLT2 inhibitors', 'placebo/standard care', 'SGLT2', 'glucose-lowering agents', 'insulin glargine', 'placebo']","['hypoglycaemia', 'fasting blood glucose', 'urinary tract infections', 'kidney function markers', 'Adverse events', 'delayed graft function', 'HbA1c and fasting blood glucose', 'transplant or graft survival, delayed graft function or death (any cause', 'kidney graft survival', 'transplant or graft survival', 'hypoglycaemia and medication discontinuation']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1505133', 'cui_str': 'SLC5A2 protein, human'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1566590', 'cui_str': 'Delayed graft function'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",16.0,0.293157,"Compared to less intensive insulin therapy, it is unclear if more intensive insulin therapy has an effect on transplant or graft survival (4 studies, 301 participants: RR 1.12, 95% CI 0.32 to 3.94; I 2  = 49%; very low certainty evidence), delayed graft function (2 studies, 153 participants: RR 0.63, 0.42 to 0.93; I 2  = 0%; very low certainty evidence), HbA1c (1 study, 16 participants; very low certainty evidence), fasting blood glucose (1 study, 24 participants; very low certainty evidence), kidney function markers (1 study, 26 participants; very low certainty evidence), death (any cause) (3 studies, 208 participants"" RR 0.68, 0.29 to 1.58; I 2  = 0%; very low certainty evidence), hypoglycaemia (4 studies, 301 participants; very low certainty evidence) and medication discontinuation due to adverse effects (1 study, 60 participants; very low certainty evidence).","[{'ForeName': 'Clement', 'Initials': 'C', 'LastName': 'Lo', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Toyama', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, Australia.'}, {'ForeName': 'Megumi', 'Initials': 'M', 'LastName': 'Oshima', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, Australia.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Jun', 'Affiliation': 'The George Institute for Global Health, UNSW, Sydney, Australia.'}, {'ForeName': 'Ken L', 'Initials': 'KL', 'LastName': 'Chin', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': 'Department of Nephrology, Princess Alexandra Hospital, Woolloongabba, Australia.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Zoungas', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD009966.pub3']
2207,32803895,After the Randomized Trial: Implementation of Community-Based Continence Promotion in the Real World.,"BACKGROUND/OBJECTIVES


Most women aged 65 and older have incontinence, associated with high healthcare costs, institutionalization, and negative quality of life, but few seek care. Mind over Matter: Healthy Bowels, Healthy Bladder (MOM) is a small-group self-management workshop, led by a trained facilitator in a community setting, proven to improve incontinence in older women.
DESIGN


We used mixed methods to gather information on the real-world adoption, maintenance, and implementation of MOM by community agencies following a randomized controlled trial (RCT) that tested intervention effects on incontinence.
SETTING


Community agencies serving older adults in six Wisconsin communities.
PARTICIPANTS


Community agency administrators and facilitators trained to offer MOM for the RCT.
MEASUREMENTS


Investigators tracked rates of adoption (offering MOM in the 12 months following the RCT) and maintenance (offering MOM more than once in the next 18 months) in six communities. Individual interviews and focus groups (N = 17) generated qualitative data about barriers and facilitators related to adoption and maintenance. Trained observers assessed implementation fidelity (alignment with program protocol) at 42 MOM sessions.
RESULTS


A total of 67% of communities (four of six) adopted MOM, and 50% (three of six) maintained MOM. No implementation fidelity lapses occurred. Facilitators of adoption and maintenance included MOM's well-organized protocol and lean time commitment, sharing of implementation efforts between partner organizations, staff specifically assigned to health promotion activities, and high community interest in continence promotion. Other than stigma associated with incontinence, barriers were similar to those seen with other community-based programs for older adults: limited funding/staffing, competing organizational priorities, challenges identifying/training facilitators, and difficulty engaging community partners/participants.
CONCLUSION


Using design for dissemination and community engagement, assessment of implementation outcomes is feasible in conjunction with a clinical RCT. Partner-centered implementation packages can address barriers to adoption and maintenance.",2020,Individual interviews and focus groups (N = 17) generated qualitative data about barriers and facilitators related to adoption and maintenance.,"['older women', 'Community agencies serving older adults in six Wisconsin communities', 'Community agency administrators and facilitators trained to offer MOM for the RCT', 'Healthy Bowels, Healthy Bladder (MOM', 'Most women aged 65 and older have incontinence']","['Mind over Matter', 'Community-Based Continence Promotion']",[],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0085751', 'cui_str': 'Administrators'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C1442163', 'cui_str': 'MoM'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]",[],,0.0766421,Individual interviews and focus groups (N = 17) generated qualitative data about barriers and facilitators related to adoption and maintenance.,"[{'ForeName': 'Nicholas B', 'Initials': 'NB', 'LastName': 'Schmuhl', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Katie A', 'Initials': 'KA', 'LastName': 'Brow', 'Affiliation': 'Virginia Tech Carilion School of Medicine, Roanoke, Virginia, USA.'}, {'ForeName': 'Meg E', 'Initials': 'ME', 'LastName': 'Wise', 'Affiliation': 'Sonderegger Research Center, University of Wisconsin-Madison School of Pharmacy, Madison, Wisconsin, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Myers', 'Affiliation': 'Wisconsin Institute for Healthy Aging, Madison, Wisconsin, USA.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Mahoney', 'Affiliation': 'Department of Medicine, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.'}, {'ForeName': 'Heidi W', 'Initials': 'HW', 'LastName': 'Brown', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Wisconsin-Madison School of Medicine and Public Health, Madison, Wisconsin, USA.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.16771']
2208,32804088,Increasing Awareness and Use of Mobile Health Technology Among Individuals With Hypertension in a Rural Community of Bangladesh: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Hypertension remains one of the foremost noncommunicable diseases that most often lead to cardiovascular diseases and its different complications. The prevalence of hypertension in Bangladesh has been increasing. However, there are very limited studies that have evaluated the impact of health education and awareness development in mitigating the burden of hypertension and its complications in Bangladesh.
OBJECTIVE


This study aims to increase awareness, enhance knowledge, and change lifestyle behaviors through health education and the use of mobile health (mHealth) technology among individuals with hypertension living in a rural community of Bangladesh.
METHODS


A randomized controlled trial is underway in a Mirzapur subdistrict of Bangladesh. This trial compares two groups of individuals with hypertension: The comparison arm receives health education and the intervention arm receives health education and a periodic mobile phone-based text message intervention. The trial duration is 5 months. The primary end point is participants' actual behavior changes brought about by increased awareness and knowledge.
RESULTS


Enrollment of participants started in August 2018, and collection of follow-up data was completed at the end of July 2019. A total of 420 participants volunteered to participate, and among them, 209 and 211 were randomly allocated to the intervention group and the control group, respectively. Among them, the ratio of males/females was 12.0/88.0 in the intervention group and 16.1/83.9 in the control group. Data cleaning and analyses have been completed and the results have been submitted for publication.
CONCLUSIONS


Periodic short education using mHealth technology in addition to face-to-face health education may be an effective method for increasing awareness and knowledge about behavioral changes and maintaining healthy lifestyle behaviors.
TRIAL REGISTRATION


Bangladesh Medical Research Council (BMRC) 06025072017; ClinicalTrials.gov NCT03614104, https://clinicaltrials.gov/ct2/show/NCT03614104; University hospital Medical Information Network (UMIN) R000033736, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_his_list.cgi?recptno=R000033736.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/15523.",2020,This trial compares two groups of individuals with hypertension: The comparison arm receives health education and the intervention arm receives health education and a periodic mobile phone-based text message intervention.,"['Individuals With Hypertension in a Rural Community of Bangladesh', 'individuals with hypertension', '420 participants volunteered to participate, and among them, 209 and 211', 'individuals with hypertension living in a rural community of Bangladesh', 'Mirzapur subdistrict of Bangladesh']","['mobile health (mHealth) technology', 'health education and the intervention arm receives health education and a periodic mobile phone-based text message intervention', 'Mobile Health Technology']",['actual behavior changes brought about by increased awareness and knowledge'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C4517774', 'cui_str': '420'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332182', 'cui_str': 'Periodic'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0332302', 'cui_str': 'Brought on by'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",420.0,0.111329,This trial compares two groups of individuals with hypertension: The comparison arm receives health education and the intervention arm receives health education and a periodic mobile phone-based text message intervention.,"[{'ForeName': 'Yasmin', 'Initials': 'Y', 'LastName': 'Jahan', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Moriyama', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Md Moshiur', 'Initials': 'MM', 'LastName': 'Rahman', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Kazawa', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Atiqur', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Department of Culture and Society, Linköping University, Norrköping, Sweden.'}, {'ForeName': 'Abu Sadat Mohammad', 'Initials': 'ASM', 'LastName': 'Sayeem Bin Shahid', 'Affiliation': 'International Centre for Diarrheal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Sumon Kumar', 'Initials': 'SK', 'LastName': 'Das', 'Affiliation': 'Menzies School of Health Research, Darwin, Northern Teritorry, Australia.'}, {'ForeName': 'Asg', 'Initials': 'A', 'LastName': 'Faruque', 'Affiliation': 'International Centre for Diarrheal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammod Jobayer', 'Initials': 'MJ', 'LastName': 'Chisti', 'Affiliation': 'International Centre for Diarrheal Disease Research, Dhaka, Bangladesh.'}]",JMIR research protocols,['10.2196/15523']
2209,32804132,Effects of Resistance Exercise with Instability on Cognitive Function (REI Study): A Proof-Of-Concept Randomized Controlled Trial in Older Adults with Cognitive Complaints.,"BACKGROUND


Activities which simultaneously challenge both physical and cognitive function are promising strategies for promoting cognitive function.
OBJECTIVE


To examine the effects of resistance exercise with instability and traditional resistance exercise compared with a health education control on cognitive function in older adults with cognitive complaints.
METHODS


Sixty-seven participants were randomized to either 12 weeks of thrice-weekly resistance exercise (RE = 23), RE with instability (REI = 22), or a weekly health education control (CON = 22). At each training session, RE and REI participants performed seven exercises for three sets and 10-15 repetitions. REI participants performed each exercise using instability devices. The primary outcome was a composite score of global cognitive function. Secondary outcomes included composite scores for cognitive sub-domains and physical function.
RESULTS


Most participants were women (REI: 77%; RE = 78%; CON = 77%; mean age of 71 years), and did not need transport to the intervention site. At completion, compared with CON, REI and RE did not significantly improve on global cognition or each cognitive sub-domain. Both exercise groups improved on the timed up and go (REI - CON: -1.6 s, 95% CI: [-2.6, -0.5]; RE - CON: -1.4 s, 95% CI: [-2.4, -0.5) and 1-RM (REI - CON: 24 kg, 95% CI: [11, 36]; RE - CON: 25 kg, 95% CI: [12, 37]). An exploratory contrast showed that compared with RE, REI promote greater gains on global cognition (2.20, 95% CI: [0.10, 4.31]) and memory (1.34; 95% CI: [0.15, 2.54]).
CONCLUSION


REI did not substantially improve cognitive function but did promote physical function among older adults with cognitive complaints. However, compared with RE, REI improved global cognition and memory.",2020,"At completion, compared with CON, REI and RE did not significantly improve on global cognition or each cognitive sub-domain.","['Older Adults with Cognitive Complaints', 'Most participants were women (REI: 77%; RE\u200a=\u200a78%; CON\u200a=\u200a77%; mean age of 71 years', 'Sixty-seven participants', 'older adults with cognitive complaints']","['REI', 'thrice-weekly resistance exercise (RE\u200a=\u200a23), RE with instability ', 'RE, REI', 'Resistance Exercise', 'RE - CON', 'CON, REI and RE', 'timed up and go (REI - CON', 'resistance exercise with instability and traditional resistance exercise', 'REI - CON', 'health education control']","['1-RM', 'global cognition', 'cognitive function', 'composite scores for cognitive sub-domains and physical function', 'global cognition and memory', 'composite score of global cognitive function']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517852', 'cui_str': '67'}]","[{'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",67.0,0.122258,"At completion, compared with CON, REI and RE did not significantly improve on global cognition or each cognitive sub-domain.","[{'ForeName': 'Bruno Remígio', 'Initials': 'BR', 'LastName': 'Cavalcante', 'Affiliation': 'Associated Graduate Program in Physical Education UPE/UFPB, University of Pernambuco, Recife-PE, Brazil.'}, {'ForeName': 'Mariana Ferreira', 'Initials': 'MF', 'LastName': 'de Souza', 'Affiliation': 'Post-graduate Program in Physical Education, Federal University of Vale do São Francisco, Petrolina-PE, Brazil.'}, {'ForeName': 'Ryan Stanley', 'Initials': 'RS', 'LastName': 'Falck', 'Affiliation': 'Department of Physical Therapy, University of British Columbia (UBC), Vancouver, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': 'Department of Physical Therapy, University of British Columbia (UBC), Vancouver, Canada.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Behm', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland St. John's, NL, Canada.""}, {'ForeName': 'Ana Carolina Rodarti', 'Initials': 'ACR', 'LastName': 'Pitangui', 'Affiliation': 'Laboratório de Pesquisa em Saúde e Desempenho Funcional (LABSED), University of Pernambuco, Petrolina-PE, Brazil.'}, {'ForeName': 'Rodrigo Cappato', 'Initials': 'RC', 'LastName': 'de Araújo', 'Affiliation': 'Laboratório de Pesquisa em Saúde e Desempenho Funcional (LABSED), University of Pernambuco, Petrolina-PE, Brazil.'}]",Journal of Alzheimer's disease : JAD,['10.3233/JAD-200349']
2210,32804188,Effect of Sustained-Release Morphine for Refractory Breathlessness in Chronic Obstructive Pulmonary Disease on Health Status: A Randomized Clinical Trial.,"Importance


Morphine is used as palliative treatment of chronic breathlessness in patients with advanced chronic obstructive pulmonary disease (COPD). Evidence on respiratory adverse effects and health status is scarce and conflicting.
Objective


To assess the effects of regular, low-dose, oral sustained-release morphine on disease-specific health status (COPD Assessment Test; CAT), respiratory outcomes, and breathlessness in patients with COPD.
Interventions


Participants were randomly assigned to 10 mg of regular, oral sustained-release morphine or placebo twice daily for 4 weeks, with the possibility to increase to 3 times daily after 1 or 2 weeks.
Design, Setting, and Participants


The Morphine for Treatment of Dyspnea in Patients With COPD (MORDYC) study was a randomized, double-blind, and placebo-controlled study of a 4-week intervention. Patients were enrolled between November 1, 2016, and January 24, 2019. Participants were recruited in a pulmonary rehabilitation center and 2 general hospitals after completion of a pulmonary rehabilitation program. Outpatients with COPD and moderate to very severe chronic breathlessness (modified Medical Research Council [mMRC] breathlessness grades 2-4) despite optimal pharmacological and nonpharmacological treatment were included. A total of 1380 patients were screened, 916 were ineligible, and 340 declined to participate.
Main Outcomes and Measures


Primary outcomes were CAT score (higher scores represent worse health status) and arterial partial pressure of carbon dioxide (Paco2). Secondary outcome was breathlessness in the previous 24 hours (numeric rating scale). Data were analyzed by intention to treat. Subgroup analyses in participants with mMRC grades 3 to 4 were performed.
Results


A total of 111 of 124 included participants were analyzed (mean [SD] age, 65.4 [8.0] years; 60 men [54%]). Difference in CAT score was 2.18 points lower in the morphine group (95% CI, -4.14 to -0.22 points; P = .03). Difference in Paco2 was 1.19 mm Hg higher in the morphine group (95% CI, -2.70 to 5.07 mm Hg; P = .55). Breathlessness remained unchanged. Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03). Five participants of 54 in the morphine group (9%) and 1 participant of 57 in the placebo group (2%) withdrew because of adverse effects. No morphine-related hospital admissions or deaths occurred.
Conclusions and Relevance


In this randomized clinical trial, regular, low-dose, oral sustained-release morphine for 4 weeks improved disease-specific health status in patients with COPD without affecting Paco2 or causing serious adverse effects. The worst breathlessness improved in participants with mMRC grades 3 to 4. A larger randomized clinical trial with longer follow-up in patients with mMRC grades 3 to 4 is warranted.
Trial Registration


ClinicalTrials.gov Identifier: NCT02429050.",2020,"Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03).","['Patients With COPD (MORDYC', 'A total of 111 of 124 included participants were analyzed (mean [SD] age, 65.4 [8.0] years; 60 men [54', 'patients with COPD without affecting Paco2 or causing serious adverse effects', 'Patients were enrolled between November 1, 2016, and January 24, 2019', 'participants with mMRC grades 3 to 4 were performed', 'Outpatients with COPD and moderate to very severe chronic breathlessness (modified Medical Research Council [mMRC] breathlessness grades 2-4', 'patients with COPD', 'A total of 1380 patients were screened, 916 were ineligible, and 340 declined to participate', 'patients with advanced chronic obstructive pulmonary disease (COPD', 'Chronic Obstructive Pulmonary Disease on Health Status', 'patients with mMRC grades 3 to 4 is warranted', 'Participants were recruited in a pulmonary rehabilitation center and 2 general hospitals after completion of a pulmonary rehabilitation program']","['regular, oral sustained-release morphine or placebo', 'morphine', 'oral sustained-release morphine', 'regular, low-dose, oral sustained-release morphine', 'Morphine', 'Sustained-Release Morphine', 'placebo']","['Worst breathlessness', 'adverse effects', 'CAT score', 'Breathlessness', 'Difference in Paco2', 'CAT score (higher scores represent worse health status) and arterial partial pressure of carbon dioxide (Paco2', 'worst breathlessness', 'hospital admissions or deaths occurred', 'disease-specific health status (COPD Assessment Test; CAT), respiratory outcomes, and breathlessness', 'disease-specific health status', 'breathlessness in the previous 24 hours (numeric rating scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517538', 'cui_str': '111'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",1380.0,0.443493,"Worst breathlessness improved in participants with mMRC grades 3 to 4 (1.33 points lower in the morphine group; 95% CI, -2.50 to -0.16 points; P = .03).","[{'ForeName': 'Cornelia A', 'Initials': 'CA', 'LastName': 'Verberkt', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Marieke H J', 'Initials': 'MHJ', 'LastName': 'van den Beuken-van Everdingen', 'Affiliation': 'Centre of Expertise for Palliative Care, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jos M G A', 'Initials': 'JMGA', 'LastName': 'Schols', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Hameleers', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Emiel F M', 'Initials': 'EFM', 'LastName': 'Wouters', 'Affiliation': 'Department of Research & Development, CIRO, Horn, the Netherlands.'}, {'ForeName': 'Daisy J A', 'Initials': 'DJA', 'LastName': 'Janssen', 'Affiliation': 'Department of Health Services Research, Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, the Netherlands.'}]",JAMA internal medicine,['10.1001/jamainternmed.2020.3134']
2211,32804205,Effect of High-Dose Erythropoietin on Blood Transfusions in Extremely Low Gestational Age Neonates: Post Hoc Analysis of a Randomized Clinical Trial.,"Importance


Extremely preterm infants are among the populations receiving the highest levels of transfusions. Erythropoietin has not been recommended for premature infants because most studies have not demonstrated a decrease in donor exposure.
Objectives


To determine whether high-dose erythropoietin given within 24 hours of birth through postmenstrual age of 32 completed weeks will decrease the need for blood transfusions.
Design, Setting, and Participants


The Preterm Erythropoietin Neuroprotection Trial (PENUT) is a randomized, double-masked clinical trial with participants enrolled at 19 sites consisting of 30 neonatal intensive care units across the United States. Participants were born at a gestational age of 24 weeks (0-6 days) to 27 weeks (6-7 days). Exclusion criteria included conditions known to affect neurodevelopmental outcomes. Of 3266 patients screened, 2325 were excluded, and 941 were enrolled and randomized to erythropoietin (n = 477) or placebo (n = 464). Data were collected from December 12, 2013, to February 25, 2019, and analyzed from March 1 to June 15, 2019.
Interventions


In this post hoc analysis, erythropoietin, 1000 U/kg, or placebo was given every 48 hours for 6 doses, followed by 400 U/kg or sham injections 3 times a week through postmenstrual age of 32 weeks.
Main Outcomes and Measures


Need for transfusion, transfusion numbers and volume, number of donor exposures, and lowest daily hematocrit level are presented herein.
Results


A total of 936 patients (488 male [52.1%]) were included in the analysis, with a mean (SD) gestational age of 25.6 (1.2) weeks and mean (SD) birth weight of 799 (189) g. Erythropoietin treatment (vs placebo) decreased the number of transfusions (unadjusted mean [SD], 3.5 [4.0] vs 5.2 [4.4]), with a relative rate (RR) of 0.66 (95% CI, 0.59-0.75); the cumulative transfused volume (mean [SD], 47.6 [60.4] vs 76.3 [68.2] mL), with a mean difference of -25.7 (95% CI, 18.1-33.3) mL; and donor exposure (mean [SD], 1.6 [1.7] vs 2.4 [2.0]), with an RR of 0.67 (95% CI, 0.58-0.77). Despite fewer transfusions, erythropoietin-treated infants tended to have higher hematocrit levels than placebo-treated infants, most noticeable at gestational week 33 in infants with a gestational age of 27 weeks (mean [SD] hematocrit level in erythropoietin-treated vs placebo-treated cohorts, 36.9% [5.5%] vs 30.4% [4.6%] (P < .001). Of 936 infants, 160 (17.1%) remained transfusion free at the end of 12 postnatal weeks, including 43 in the placebo group and 117 in the erythropoietin group (P < .001).
Conclusions and Relevance


These findings suggest that high-dose erythropoietin as used in the PENUT protocol was effective in reducing transfusion needs in this population of extremely preterm infants.
Trial Registration


ClinicalTrials.gov Identifier: NCT01378273.",2020,"Despite fewer transfusions, erythropoietin-treated infants tended to have higher hematocrit levels than placebo-treated infants, most noticeable at gestational week 33 in infants with a gestational age of 27 weeks (mean [SD] hematocrit level in erythropoietin-treated vs placebo-treated cohorts, 36.9% [5.5%] vs 30.4% [4.6%] (P < .001).","['Participants were born at a gestational age of 24 weeks (0-6 days) to 27 weeks (6-7 days', '936 patients (488 male [52.1%]) were included in the analysis, with a mean (SD) gestational age of 25.6 (1.2) weeks and mean (SD) birth weight of 799 (189) g', '3266 patients screened, 2325 were excluded, and 941 were enrolled and randomized to', 'Extremely Low Gestational Age Neonates', 'participants enrolled at 19 sites consisting of 30 neonatal intensive care units across the United States', 'Data were collected from December 12, 2013, to February 25, 2019, and analyzed from March 1 to June 15, 2019']","['Erythropoietin treatment (vs placebo', 'High-Dose Erythropoietin', 'erythropoietin', 'Erythropoietin', 'placebo']","['Measures\n\n\nNeed for transfusion, transfusion numbers and volume, number of donor exposures, and lowest daily hematocrit level', 'number of transfusions', 'Blood Transfusions', 'transfusion free', 'hematocrit levels', 'cumulative transfused volume']","[{'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1963096', 'cui_str': 'AE-941'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",936.0,0.764264,"Despite fewer transfusions, erythropoietin-treated infants tended to have higher hematocrit levels than placebo-treated infants, most noticeable at gestational week 33 in infants with a gestational age of 27 weeks (mean [SD] hematocrit level in erythropoietin-treated vs placebo-treated cohorts, 36.9% [5.5%] vs 30.4% [4.6%] (P < .001).","[{'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Washington, Seattle.'}, {'ForeName': 'Phuong T', 'Initials': 'PT', 'LastName': 'Vu', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Bryan A', 'Initials': 'BA', 'LastName': 'Comstock', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': 'Rajan', 'Initials': 'R', 'LastName': 'Wadhawan', 'Affiliation': 'Department of Neonatal-Perinatal Medicine, AdventHealth, Orlando, Florida.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Mayock', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Washington, Seattle.'}, {'ForeName': 'Sherry E', 'Initials': 'SE', 'LastName': 'Courtney', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Arkansas, Little Rock.'}, {'ForeName': 'Tonya', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Kaashif A', 'Initials': 'KA', 'LastName': 'Ahmad', 'Affiliation': ""Department of Neonatal Medicine, Methodist Children's Hospital, San Antonio, Texas.""}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Bendel-Stenzel', 'Affiliation': ""Department of Neonatology, Children's Minnesota, Minneapolis.""}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Baserga', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Utah, Salt Lake City.'}, {'ForeName': 'Edmund F', 'Initials': 'EF', 'LastName': 'LaGamma', 'Affiliation': ""Department of Neonatal Medicine, Maria Fareri Children's Hospital at Westchester, Valhalla, New York.""}, {'ForeName': 'L Corbin', 'Initials': 'LC', 'LastName': 'Downey', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Shea"", 'Affiliation': ""Division of Neonatology, Department of Pediatrics, University of Minnesota Masonic Children's Hospital, Minneapolis.""}, {'ForeName': 'Raghavendra', 'Initials': 'R', 'LastName': 'Rao', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, University of Minnesota Masonic Children's Hospital, Minneapolis.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Fahim', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, University of Minnesota Masonic Children's Hospital, Minneapolis.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lampland', 'Affiliation': ""Department of Neonatology, Children's Minnesota, St Paul.""}, {'ForeName': 'Ivan D', 'Initials': 'ID', 'LastName': 'Frantz', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Khan', 'Affiliation': ""Division of Neonatology, Department of Pediatrics, Prentice Women's Hospital, Chicago, Illinois.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weiss', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Gilmore', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Ohls', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of New Mexico, Albuquerque.'}, {'ForeName': 'Nishant', 'Initials': 'N', 'LastName': 'Srinivasan', 'Affiliation': ""Department of Pediatrics, Children's Hospital of the University of Illinois, Chicago.""}, {'ForeName': 'Jorge E', 'Initials': 'JE', 'LastName': 'Perez', 'Affiliation': 'Department of Neonatology, South Miami Hospital, South Miami, Florida.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'McKay', 'Affiliation': ""Department of Neonatology, Johns Hopkins All Children's Hospital, St. Petersburg, Florida.""}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA pediatrics,['10.1001/jamapediatrics.2020.2271']
2212,32801821,"308-nm Excimer Laser Plus Platelet-Rich Plasma for Treatment of Stable Vitiligo: A Prospective, Randomized Case-Control Study.","Purpose


308-nm excimer laser has a confirmed treatment effect on vitiligo. Platelet-rich plasma (PRP) is an autologous preparation which contains a variety of growth factors. The effect of 308-nm excimer laser combined with PRP on vitiligo has been rarely reported. This study investigated the effect of PRP combined with 308-nm excimer laser on stable vitiligo.
Patients and Methods


A total of 60 patients with localized stable vitiligo who received treatment at Beijing Friendship Hospital and Xi'an Vitiligo Specialist Hospital between May 2019 and January 2020 were consecutively enrolled. They were equally randomized into three groups according to different treatment methods: intradermal PRP injection (group I), 308-nm excimer laser alone (group II), and 308-nm excimer laser plus PRP injection (group III). All treatments lasted for 3 months. At 3 months after treatment, clinical assessments were performed in terms of the visual analogue scale (VAS) score, repigmentation response and side effects.
Results


The VAS scores showed significant differences among the three groups (P<0.001), with the highest score in group III, followed by group II and then group I. Repigmentation responses also showed significant differences among the groups (P<0.001), and the best effect was observed in group III. No side effects were reported in any of the groups.
Conclusion


The effect of PRP combined with 308-nm excimer laser on stable vitiligo is significantly better than that of PRP and 308-nm excimer laser alone. It is safe and satisfactorily tolerant.",2020,"The VAS scores showed significant differences among the three groups (P<0.001), with the highest score in group III, followed by group II and then group I. Repigmentation responses also showed significant differences among the groups (P<0.001), and the best effect was observed in group III.","[""60 patients with localized stable vitiligo who received treatment at Beijing Friendship Hospital and Xi'an Vitiligo Specialist Hospital between May 2019 and January 2020 were consecutively enrolled"", 'Stable Vitiligo']","['Platelet-rich plasma (PRP', 'PRP combined with 308-nm excimer laser', 'intradermal PRP injection', '308-nm excimer laser combined with PRP', '308-nm excimer laser plus PRP injection', '308-nm Excimer Laser Plus Platelet-Rich Plasma', '308-nm excimer laser alone', '308-nm excimer laser']","['stable vitiligo', 'side effects', 'visual analogue scale (VAS) score, repigmentation response and side effects', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0392265', 'cui_str': 'Excimer laser device'}, {'cui': 'C1522475', 'cui_str': 'Intradermal route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",60.0,0.0245312,"The VAS scores showed significant differences among the three groups (P<0.001), with the highest score in group III, followed by group II and then group I. Repigmentation responses also showed significant differences among the groups (P<0.001), and the best effect was observed in group III.","[{'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': ""Department of Dermatology, Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing 100050, People's Republic of China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Dermatology, Taiyuan Central Hospital of Shanxi Medical University, Taiyuan 030009, People's Republic of China.""}, {'ForeName': 'Gaoyun', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': ""Department of Dermatology, Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing 100050, People's Republic of China.""}]","Clinical, cosmetic and investigational dermatology",['10.2147/CCID.S260434']
2213,32801822,Examining Quality of Life After Treatment with Azelaic and Pyruvic Acid Peels in Women with Acne Vulgaris.,"Purpose


This randomized parallel study aims to investigate the azelaic acid (AA), and pyruvic acid (PA) peels treatment effect on health-related quality of life (QOL) in young adult women with acne vulgaris.
Patients and Methods


The participants were 120 female undergraduate students, with mild to moderate facial acne and an average age of 22 years old (M = 22.2, SD = 16.1). Eligibility criteria were as follows: female gender, 18-25 years of age, no dermatological treatment within the last 12 months and mild to moderate papulopustular acne. Patients were randomly divided into two groups, the first group was treated with AA, and the second group was treated with PA. Both groups received treatment every 2 weeks, for a total of 12 weeks. The Hellgren-Vincent scale was used to assess acne severity, and the Dermatology Life Quality Index (DLQI) and Skindex-29 were used to evaluate the quality of life of each patient. These scores were calculated before treatment, and after finishing the final treatment.
Results


All scoring systems used (Hellgren-Vincent scale, DLQI, and Skindex-29) demonstrated improvement in both groups. QOL scores were slightly better in the group using pyruvic acid compared with azelaic acid.
Conclusion


Both AA and PA have a significant impact on the objective assessment of acne symptoms, as well as the subjectively measured quality of life of young adult women with acne. There is a slightly greater improvement in QOL scores with PA compared with AA peeling treatment.",2020,"All scoring systems used (Hellgren-Vincent scale, DLQI, and Skindex-29) demonstrated improvement in both groups.","['participants were 120 female undergraduate students, with mild to moderate facial acne and an average age of 22 years old (M = 22.2, SD = 16.1', 'young adult women with acne vulgaris', 'Eligibility criteria were as follows: female gender, 18-25 years of age, no dermatological treatment within the last 12 months and mild to moderate papulopustular acne', 'Women with Acne Vulgaris', 'young adult women with acne']","['Azelaic and Pyruvic Acid Peels', 'azelaic acid (AA), and pyruvic acid (PA) peels', 'PA']","['Dermatology Life Quality Index (DLQI', 'health-related quality of life (QOL', 'Examining Quality of Life', 'QOL scores']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C0011625', 'cui_str': 'DERMATOLOGICALS'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0072802', 'cui_str': 'Pyruvic acid'}, {'cui': 'C0237849', 'cui_str': 'Peeling of skin'}, {'cui': 'C0052761', 'cui_str': 'azelaic acid'}]","[{'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.0409581,"All scoring systems used (Hellgren-Vincent scale, DLQI, and Skindex-29) demonstrated improvement in both groups.","[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Chilicka', 'Affiliation': 'Faculty of Health Sciences, University of Opole, Opole, Poland.'}, {'ForeName': 'Aleksandra M', 'Initials': 'AM', 'LastName': 'Rogowska', 'Affiliation': 'Institute of Psychology, University of Opole, Opole, Poland.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Szyguła', 'Affiliation': 'Faculty of Health Sciences, University of Opole, Opole, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Taradaj', 'Affiliation': 'Institute of Physiotherapy and Health Sciences, Academy of Physical Education, Katowice, Poland.'}]","Clinical, cosmetic and investigational dermatology",['10.2147/CCID.S262691']
2214,32801843,The Safety and Efficacy of Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Combined with Dexmedetomidine for Patients Undergoing Video-Assisted Thoracic Surgery (VATS): A Randomized Controlled Trial.,"Background


Although video-assisted thoracic surgery (VATS) can significantly reduce postoperative pain, the incidence is as high as 30-50%. The purpose of this study was to explore the safety and efficacy of ultrasound-guided serratus anterior plane block (SAPB) combined with dexmedetomidine (Dex) for patients undergoing VATS.
Methods


Eighty patients were randomized into two groups (20 mL 0.5% ropivacaine plus 0.5 µg/kg or 1 µg/kg Dex). Primary outcome was the visual analog scale of pain while coughing (VASc) score at 24 h after surgery. Secondary outcomes included hemodynamics, sufentanil consumption, number of patients needing rescue analgesia, time to first rescue analgesic, total dose of rescue analgesic, satisfaction scores of patients and surgeons, time of chest tube removal, length of hospital stay, adverse effects, the prevalence of chronic pain and quality of life.
Results


Compared with D1 group, visual analog scale of pain at rest (VASr) was significantly lower during the first 24 h after surgery, while VASc was significantly lower during the first 48 h after surgery ( P <0.05). Mean arterial pressure was significantly decreased from T2 to T8, and heart rate was significantly decreased from T2 to T7 in the D2 group ( P <0.05). Consumption of sevoflurane, remifentanil, DEX and the recovery time were significantly reduced in the D2 group ( P  <0.05). Consumption of sufentanil 8-72 h after surgery was significantly lower in the D2 group ( P <0.05). Additionally, the number of patients who required rescue analgesia, the time to the first dose of rescue analgesia, and the total dose of rescue analgesia was significantly lower in the D2 group ( P <0.05).
Conclusion


The results of this study show that 1 µg/kg DEX is a beneficial adjuvant to ropivacaine for single-injection SAPB in VATS patients while stable hemodynamics were maintained.",2020,"Consumption of sevoflurane, remifentanil, DEX and the recovery time were significantly reduced in the D2 group ( P  <0.05).","['Methods\n\n\nEighty patients', 'Patients Undergoing Video-Assisted Thoracic Surgery (VATS', 'patients undergoing VATS']","['ultrasound-guided serratus anterior plane block (SAPB) combined with dexmedetomidine (Dex', 'video-assisted thoracic surgery (VATS', 'ropivacaine plus 0.5 µg/kg or 1 µg/kg Dex', 'DEX', 'sufentanil', 'ropivacaine', 'Ultrasound-Guided Serratus Anterior Plane Block (SAPB) Combined with Dexmedetomidine', 'sevoflurane, remifentanil, DEX']","['hemodynamics, sufentanil consumption, number of patients needing rescue analgesia, time to first rescue analgesic, total dose of rescue analgesic, satisfaction scores of patients and surgeons, time of chest tube removal, length of hospital stay, adverse effects, the prevalence of chronic pain and quality of life', 'postoperative pain', 'Mean arterial pressure', 'heart rate', 'visual analog scale of pain at rest (VASr', 'recovery time', 'safety and efficacy', 'total dose of rescue analgesia', 'visual analog scale of pain while coughing (VASc) score']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C2224175', 'cui_str': 'Chest tube removal'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}]",80.0,0.251207,"Consumption of sevoflurane, remifentanil, DEX and the recovery time were significantly reduced in the D2 group ( P  <0.05).","[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, The First People's Hospital of Tianmen, Tianmen, Hubei, People's Republic of China.""}, {'ForeName': 'Yanchao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, Liaocheng People's Hospital, Liaocheng, Shandong, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Anesthesiology, Liaocheng People's Hospital, Liaocheng, Shandong, People's Republic of China.""}, {'ForeName': 'Zhixiong', 'Initials': 'Z', 'LastName': 'Xiang', 'Affiliation': ""Department of Anesthesiology, The First People's Hospital of Tianmen, Tianmen, Hubei, People's Republic of China.""}, {'ForeName': 'Chunguang', 'Initials': 'C', 'LastName': 'Ren', 'Affiliation': ""Department of Anesthesiology, Liaocheng People's Hospital, Liaocheng, Shandong, People's Republic of China.""}, {'ForeName': 'Kekun', 'Initials': 'K', 'LastName': 'Qiao', 'Affiliation': ""Department of Anesthesiology, The First People's Hospital of Tianmen, Tianmen, Hubei, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S258443']
2215,32801847,"Erratum: Low-Intensity Continuous Ultrasound for the Symptomatic Treatment of Upper Shoulder and Neck Pain: A Randomized, Double-Blind Placebo-Controlled Clinical Trial [Corrigendum].",[This corrects the article DOI: 10.2147/JPR.S247463.].,2020,[This corrects the article DOI: 10.2147/JPR.S247463.].,['Upper Shoulder and Neck Pain'],['Placebo'],[],"[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.604013,[This corrects the article DOI: 10.2147/JPR.S247463.].,[],Journal of pain research,['10.2147/JPR.S272270']
2216,32801849,Preemptive Nalbuphine Attenuates Remifentanil-Induced Postoperative Hyperalgesia After Laparoscopic Cholecystectomy: A Prospective Randomized Double-Blind Clinical Trial.,"Background


Remifentanil-induced hyperalgesia (RIH) is a paradoxical phenomenon that may increase sensitivity to painful stimuli. Nalbuphine, which is both a  μ- receptor antagonist and  κ- receptor agonist, may affect RIH. The aim of this study was to evaluate the effects of nalbuphine on RIH during laparoscopic cholecystectomy.
Methods


A total of 96 patients were divided into the following four groups: 0.4 μg/kg/min of remifentanil with 0.2 mg/kg of nalbuphine (HRNA), 0.4 μg/kg/min of remifentanil with saline (HRSA), 0.1 μg/kg/min of remifentanil with 0.2 mg/kg of nalbuphine (LRNA), and 0.1 μg/kg/min of remifentanil with saline (LRSA). The pain thresholds of postoperative mechanical hyperalgesia were measured with von Frey filaments. Pain intensity and analgesic consumption were recorded up to 48 h after surgery.
Results


Pain thresholds on the inner forearm decreased in the HRSA group compared with the HRNA ( P  = 0.0167), LRNA ( P  = 0.0027), and LRSA ( P  = 0.0318) groups at 24 h after surgery. Pain thresholds on the peri-incisional area decreased in the HRSA group compared with HRNA, LRNA, and LRSA (all  P  < 0.0001) groups at 24 h after surgery. Patients in the HRNA group showed lower numeric rating scale scores at 1 h ( P  = 0.0159), 3 h ( P  = 0.0118), 6 h ( P  = 0.0213), and 12 h ( P  = 0.0118) than those in the HRSA group. Postoperative requirement for sufentanil was greater in the HRSA group than the HRNA group during the first 3 h ( P  = 0.0321) and second 3 h ( P  = 0.0040). Postoperative sufentanil consumption was also greater in the LRSA group than in the LRNA group during the first 3 h ( P  = 0.0321) and second 3 h ( P  = 0.0416).
Conclusion


Preemptive nalbuphine can ameliorate postoperative hyperalgesia induced by high-dose remifentanil in patients undergoing laparoscopic cholecystectomy.",2020,"Patients in the HRNA group showed lower numeric rating scale scores at 1 h ( P  = 0.0159), 3 h ( P  = 0.0118), 6 h ( P  = 0.0213), and 12 h ( P  = 0.0118) than those in the HRSA group.","['96 patients', 'patients undergoing laparoscopic cholecystectomy']","['Remifentanil-induced hyperalgesia (RIH', 'Preemptive nalbuphine', 'nalbuphine', 'remifentanil with saline (LRSA', 'LRNA', 'remifentanil with saline (HRSA), 0.1 μg/kg/min of remifentanil with 0.2 mg/kg of nalbuphine (LRNA', 'Laparoscopic Cholecystectomy', 'HRNA', 'sufentanil', 'LRSA', 'remifentanil with 0.2 mg/kg of nalbuphine (HRNA', 'HRSA', 'remifentanil', 'receptor antagonist and  κ', 'Nalbuphine']","['numeric rating scale scores', 'Postoperative sufentanil consumption', 'LRNA', 'postoperative hyperalgesia', 'pain thresholds of postoperative mechanical hyperalgesia', 'Pain thresholds on the inner forearm', 'Pain intensity and analgesic consumption', 'Pain thresholds on the peri-incisional area', 'Postoperative Hyperalgesia', 'Postoperative requirement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0041720', 'cui_str': 'Health Resources and Services Administration'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C2936719', 'cui_str': 'Allodynia, Mechanical'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",96.0,0.304284,"Patients in the HRNA group showed lower numeric rating scale scores at 1 h ( P  = 0.0159), 3 h ( P  = 0.0118), 6 h ( P  = 0.0213), and 12 h ( P  = 0.0118) than those in the HRSA group.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': ""Department of Anesthesiology, The Second Hospital of Anhui Medical University, Hefei, People's Republic of China.""}, {'ForeName': 'Shuangshuang', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, Tongling People's Hospital of Anhui Medical University, Tongling, Anhui, People's Republic of China.""}, {'ForeName': 'Mudan', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ""Department of Anesthesiology, Tongling People's Hospital of Anhui Medical University, Tongling, Anhui, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Anesthesiology, The Second Hospital of Anhui Medical University, Hefei, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Tongling People's Hospital of Anhui Medical University, Tongling, Anhui, People's Republic of China.""}, {'ForeName': 'Jinbao', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, Tongling People's Hospital of Anhui Medical University, Tongling, Anhui, People's Republic of China.""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, The Second Hospital of Anhui Medical University, Hefei, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S257018']
2217,32802039,Effect and Safety of Transcutaneous Auricular Vagus Nerve Stimulation on Recovery of Upper Limb Motor Function in Subacute Ischemic Stroke Patients: A Randomized Pilot Study.,"Background


Transcutaneous auricular vagus nerve stimulation (taVNS) is regarded as a potential method for recovery in stroke. The effectiveness of taVNS in acute and subacute stroke should be further discussed as previously, only a few small-scale trials have focused on chronic stroke patients. The objective of this study is to investigate the effect and safety of taVNS on upper limb motor function in subacute ischemic stroke patients.
Methods


Twenty-one subacute ischemia stroke patients with single upper limb motor function impairment were enrolled and randomly assigned to conventional rehabilitation training with real or sham taVNS, delivered for 15 consecutive days. Electrodes were fixed to the cymba conchae of the left ear with or without electrical stimulation. Conventional rehabilitation training was performed immediately after the end of real or sham taVNS by the same therapists. Baseline assessments were performed on day 0 of enrollment, and posttreatment evaluations were performed at 15 days, 4 weeks, and 12 weeks after the first intervention. The assessment included the upper limb Fugl-Meyer assessment (FMA-U), the Wolf motor function test (WMFT), the Functional Independence Measurement (FIM), and Brunnstrom stage. Heart rate (HR) and blood pressure (BP) were measured before and after each taVNS intervention. At the same time, any adverse effects were observed during the procedure. Outcomes were assessed by a blind evaluator.
Results


There were no significant differences in FMA-U, WMFT, FIM, and Brunnstrom scores between the two groups at baseline ( P  > 0.05). At the endpoint, the FMA-U, WMFT, and FIM scores were significantly higher than before treatment ( P  < 0.05), and there was a significantly greater improvement of those measurements in taVNS group compared with sham-taVNS group ( P  < 0.05). Significant improvements in FMA-U score were found between groups at follow-up. Only one case of skin redness occurred during the study.
Conclusions


This study revealed that taVNS appeared to be beneficial to the recovery of upper limb motor function in subacute ischemia stroke patients without obvious adverse effects.  Trial registration . This trial is registered with ChiCTR1800019635 on 20 November 2018 (http://www.chictr.org.cn/showproj.aspx?proj=32961).",2020,"There were no significant differences in FMA-U, WMFT, FIM, and Brunnstrom scores between the two groups at baseline ( P  > 0.05).","['20 November 2018 (http://www.chictr.org.cn/showproj.aspx?proj=32961', 'subacute ischemia stroke patients', 'Methods\n\n\nTwenty-one subacute ischemia stroke patients with single upper limb motor function impairment', 'Subacute Ischemic Stroke Patients', 'subacute ischemic stroke patients', 'chronic stroke patients']","['Transcutaneous Auricular Vagus Nerve Stimulation', 'taVNS', 'conventional rehabilitation training with real or sham taVNS', '\n\n\nTranscutaneous auricular vagus nerve stimulation (taVNS', 'Conventional rehabilitation training']","['FMA-U score', 'skin redness', 'FMA-U, WMFT, FIM, and Brunnstrom scores', 'Heart rate (HR) and blood pressure (BP', 'FMA-U, WMFT, and FIM scores', 'adverse effects', 'upper limb Fugl-Meyer assessment (FMA-U), the Wolf motor function test (WMFT), the Functional Independence Measurement (FIM), and Brunnstrom stage']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",21.0,0.0807745,"There were no significant differences in FMA-U, WMFT, FIM, and Brunnstrom scores between the two groups at baseline ( P  > 0.05).","[{'ForeName': 'Dandong', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, 76 Linjiang Road, Yuzhong District, Chongqing 400010, China.'}, {'ForeName': 'Jingxi', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Neurology, Chongqing General Hospital, University of Chinese Academy of Sciences, Yuzhong District, Chongqing 400013, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Chongqing Medical University, 1 Yixueyuan Road, Yuzhong District, Chongqing 400010, China.'}, {'ForeName': 'Sanrong', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, 76 Linjiang Road, Yuzhong District, Chongqing 400010, China.'}, {'ForeName': 'Botao', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, 76 Linjiang Road, Yuzhong District, Chongqing 400010, China.'}, {'ForeName': 'Gongwei', 'Initials': 'G', 'LastName': 'Jia', 'Affiliation': 'Department of Rehabilitation Medicine, The Second Affiliated Hospital of Chongqing Medical University, 76 Linjiang Road, Yuzhong District, Chongqing 400010, China.'}]",Neural plasticity,['10.1155/2020/8841752']
2218,32802048,Telephone-Based Reeducation of Drug Administration for  Helicobacterpylori  Eradication: A Multicenter Randomized Controlled Study.,"Poor adherence to treatment instructions may play an important role in the failure of  Helicobacter pylori  eradication. The aim of this study was to evaluate the effects of telephone-based reeducation on 14-day quadruple  H .  pylori  eradication therapy. In total, 162 patients were randomly assigned (1 : 1) to either the intervention group (patients received telephone-based reeducation on the 4 th , 7 th , and 10 th  days of the course) or the control group (patients received instructions only at the time of getting the prescriptions). All patients received a 14-day quadruple  H .  pylori  eradication therapy. The primary outcome was the  H .  pylori  eradication rate. The secondary outcomes included the symptom relief rates and the incidence rates of adverse events. Seventy-five patients in the reeducation group and 74 patients in the control group completed the follow-up. The  H .  pylori  eradication rate in the reeducation group was statistically higher than that in the control group (intention-to-treat: 72.8% vs. 50.6%,  P  = 0.006; per-protocol: 78.7% vs. 55.4%,  P  = 0.003). However, the symptom relief rates and the adverse event rates in these two groups were not significantly different. Overall, the results from this study suggest that telephone-based reeducation can be potentially applied to improve the  H .  pylori  eradication rate in clinical practice, without significantly increasing the adverse effects.",2020,"pylori  eradication rate in the reeducation group was statistically higher than that in the control group (intention-to-treat: 72.8% vs. 50.6%,  P  = 0.006; per-protocol: 78.7% vs. 55.4%,  P  = 0.003).","['Seventy-five patients in the reeducation group and 74 patients in the control group completed the follow-up', '162 patients']","['telephone-based reeducation', 'Helicobacterpylori  Eradication', 'Telephone-Based Reeducation of Drug Administration for']","['H ', 'adverse event rates', 'symptom relief rates', 'symptom relief rates and the incidence rates of adverse events', 'adverse effects', 'pylori  eradication rate']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C5191360', 'cui_str': '162'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",162.0,0.0373025,"pylori  eradication rate in the reeducation group was statistically higher than that in the control group (intention-to-treat: 72.8% vs. 50.6%,  P  = 0.006; per-protocol: 78.7% vs. 55.4%,  P  = 0.003).","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Gastroenterology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Mudan', 'Initials': 'M', 'LastName': 'Ren', 'Affiliation': ""Department of Gastroenterology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Guifang', 'Initials': 'G', 'LastName': 'Lu', 'Affiliation': ""Department of Gastroenterology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Xinlan', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': ""Department of Gastroenterology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastroenterology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.""}, {'ForeName': 'Shuixiang', 'Initials': 'S', 'LastName': 'He', 'Affiliation': ""Department of Gastroenterology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.""}]",Gastroenterology research and practice,['10.1155/2020/8972473']
2219,32802051,Dose Comparison of Dexmedetomidine Sedation following Spinal Anesthesia: Parturient versus Nonpregnant Women-A Randomized Trial.,"Background


This study was designed to investigate and compare the effective doses of dexmedetomidine for sedation in parturient patients who underwent Cesarean section (CS) and nonpregnant women who underwent elective gynecologic surgery.
Methods


The study comprised 60 females aged between 25 and 35. They were divided into two groups. The parturient group received a bolus dose of dexmedetomidine over 15 min after the delivery of the fetus and placenta. In the nonpregnant women group, a bolus of dexmedetomidine was administered intravenously upon the completion of spinal anesthesia. The subsequent dose required by patients in each group was then determined through a modified two-stage Dixon up-and-down sequential method. Probit analysis was used to calculate the ED50 and the ED95 of dexmedetomidine for adequate sedation.
Results


The ED50 of dexmedetomidine for adequate sedation in parturient patients was 1.58  μ g/kg (1.51-1.66  μ g/kg); in nonpregnant women, it was 0.96  μ g/kg (0.91-1.01  μ g/kg) (95% CI). The ED95 of dexmedetomidine in parturients was 1.80  μ g/kg (1.70-2.16)  μ g/kg and that of nonpregnant women was 1.10  μ g/kg (1.04-1.30  μ g/kg) (95% CI). The ED50 in parturients was significantly higher than that in nonpregnant women ( P  < 0.05).
Conclusion


The ED50 of dexmedetomidine for target sedation in parturients who received spinal anesthesia for CS is greater than 1.5 times that in nonpregnant women who received spinal anesthesia for lower abdominal gynecologic surgery. This study postulates that the dose of dexmedetomidine required to achieve optimal sedation following spinal anesthesia is much higher in parturients than in nonpregnant women undergoing gynecologic surgeries. This trial is registered with NCT02111421.",2020,"The ED50 in parturients was significantly higher than that in nonpregnant women ( P  < 0.05).
","['parturients than in nonpregnant women undergoing gynecologic surgeries', 'Spinal Anesthesia', 'parturient patients who underwent Cesarean section (CS) and nonpregnant women who underwent elective gynecologic surgery', '60 females aged between 25 and 35', 'parturients who received']","['Dexmedetomidine Sedation', 'spinal anesthesia for CS', 'dexmedetomidine', 'spinal anesthesia']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]",[],60.0,0.166048,"The ED50 in parturients was significantly higher than that in nonpregnant women ( P  < 0.05).
","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Xiong', 'Affiliation': 'Department of Anesthesiology, General Hospital of Southern Theatre Command of PLA, Guangzhou, China.'}, {'ForeName': 'Biyun', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, General Hospital of Southern Theatre Command of PLA, Guangzhou, China.'}, {'ForeName': 'Zurong', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, General Hospital of Southern Theatre Command of PLA, Guangzhou, China.'}, {'ForeName': 'Somdatta', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Anesthesiology and Preoperative Medicine, Rutgers-NJMS, Newark, NJ 07101, USA.'}, {'ForeName': 'Zhitao', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, General Hospital of Southern Theatre Command of PLA, Guangzhou, China.'}, {'ForeName': 'Jiping', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, General Hospital of Southern Theatre Command of PLA, Guangzhou, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Anesthesiology, General Hospital of Southern Theatre Command of PLA, Guangzhou, China.'}, {'ForeName': 'Shivani', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Department of Anesthesiology and Preoperative Medicine, Rutgers-NJMS, Newark, NJ 07101, USA.'}, {'ForeName': 'Jean Daniel', 'Initials': 'JD', 'LastName': 'Eloy', 'Affiliation': 'Department of Anesthesiology and Preoperative Medicine, Rutgers-NJMS, Newark, NJ 07101, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, General Hospital of Southern Theatre Command of PLA, Guangzhou, China.'}]",Anesthesiology research and practice,['10.1155/2020/1059807']
2220,32802114,Effect of Electroacupuncture versus Sham Electroacupuncture in Patients with Knee Osteoarthritis: A Pilot Randomized Controlled Trial.,"Objective


To explore the feasibility of evaluating the effectiveness and safety of electroacupuncture versus sham electroacupuncture for patients with knee osteoarthritis (KOA).
Method


A pilot randomized controlled trial was conducted at a teaching hospital in Beijing. A total of 30 patients with KOA (Kellgren grade II or III) were randomly allocated to an eight-week treatment of either electroacupuncture or sham electroacupuncture. Patients and outcome assessors were blinded to group allocation. The primary outcome was the proportion of responders achieving at least 1.14 seconds decrease in the Timed Up and Go Test (TUG) at week eight compared with baseline. The secondary outcomes included the knee range of motion, the knee extensor and flexor muscle strength, Lequesne index, 9-step stair-climb test (9-SCT), and TUG.
Results


Of 30 patients allocated to two groups, 27 (90%) completed the study. The proportion of responders was 53.3% (8 of 15) for electroacupuncture group and 26.7% (4 of 15) for sham electroacupuncture group by the intention-to-treat analysis ( P  = 0.264). There was no statistically significant difference in TUG between the two groups at eight weeks ( P  = 0.856). The compliance rate measured according to patients who conformed to the protocol and had received treatments ≥20 times was 93.3% (28 of 30). The dropout rate was 20% (3 of 15). Adverse effects were not reported in the study.
Conclusion


Our research demonstrated that further evaluation of the effectiveness of electroacupuncture versus sham electroacupuncture was feasible and safe for patients with KOA. Whether or not the electroacupuncture can improve the physical functions of knee joint, expand the knee range of motion, and increase the extensor and flexor muscle strength more significantly than sham electroacupuncture, future studies can be designed with larger sample size, randomization design and less biases. This trial is registered with NCT03366363.",2020,There was no statistically significant difference in TUG between the two groups at eight weeks ( P  = 0.856).,"['patients with knee osteoarthritis (KOA', 'Patients with Knee Osteoarthritis', '30 patients with KOA (Kellgren grade II or III', '30 patients allocated to two groups, 27 (90%) completed the study', 'teaching hospital in Beijing', 'patients with KOA']","['Sham Electroacupuncture', 'electroacupuncture', 'Electroacupuncture', 'electroacupuncture or sham electroacupuncture', 'electroacupuncture versus sham electroacupuncture']","['dropout rate', 'TUG', 'proportion of responders achieving at least 1.14 seconds decrease in the Timed Up and Go Test (TUG', 'knee range of motion, the knee extensor and flexor muscle strength, Lequesne index, 9-step stair-climb test (9-SCT), and TUG', 'Adverse effects', 'extensor and flexor muscle strength', 'compliance rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C4042832', 'cui_str': 'Peking'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C4517492', 'cui_str': '1.14'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0576094', 'cui_str': 'Knee joint - range of movement'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0451257', 'cui_str': 'Lequesne index'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",30.0,0.144806,There was no statistically significant difference in TUG between the two groups at eight weeks ( P  = 0.856).,"[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Lv', 'Affiliation': 'Department of Acupuncture and Moxibustion, HuGuoSi Hospital of Traditional Chinese Medicine Affiliated with Beijing University of Chinese Medicine and Pharmacology, Beijing, China.'}, {'ForeName': 'Zhao-Tian', 'Initials': 'ZT', 'LastName': 'Sun', 'Affiliation': 'Department of Acupuncture and Moxibustion, HuGuoSi Hospital of Traditional Chinese Medicine Affiliated with Beijing University of Chinese Medicine and Pharmacology, Beijing, China.'}, {'ForeName': 'Jian-Feng', 'Initials': 'JF', 'LastName': 'Tu', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Chaoyang District, Beijing, China.'}, {'ForeName': 'Yong-Wei', 'Initials': 'YW', 'LastName': 'Feng', 'Affiliation': 'Department of Acupuncture and Moxibustion, HuGuoSi Hospital of Traditional Chinese Medicine Affiliated with Beijing University of Chinese Medicine and Pharmacology, Beijing, China.'}, {'ForeName': 'Tian-Qi', 'Initials': 'TQ', 'LastName': 'Wang', 'Affiliation': 'School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Chaoyang District, Beijing, China.'}, {'ForeName': 'Cun-Zhi', 'Initials': 'CZ', 'LastName': 'Liu', 'Affiliation': 'Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/1686952']
2221,32802127,A Placebo-Controlled Study on the Treatment of Metabolic Syndrome of Qi Stagnation and Dampness Obstruction Related to Atypical Antipsychotics with Traditional Chinese Medicine (TCM).,"Methods


154 schizophrenics who met both the diagnostic criteria of metabolic syndrome and qi stagnation and dampness obstruction syndrome were randomly divided into 2 : 1 groups. The PANSS and Tess were assessed before treatment and at the end of first month, second month, and third month after treatment; blood pressure, weight, waist circumference, hip circumference, blood glucose, glycosylated hemoglobin, high-density lipoprotein, low-density lipoprotein, triglyceride, and cholesterol were also measured at the same four time points. On the basis of continuous antipsychotic treatment, the study group took Liuyu decoction, and the control group took placebo.
Results


Of the 154 cases, 102 were in the study group and 52 in the control group. Before and after treatment, there was a slight increase but no significant difference in blood pressure, blood sugar, glycosylated hemoglobin, cholesterol, TG, DHL, and LHL in two groups ( P  > 0.05) and also between the two groups ( P  > 0.05). The body weight, waist circumference, hip circumference, and BMI in the study group decreased, while that in the control group increased from the dividing group to the end of study. At the end of the third month, there was a significant difference in the body weight, waist circumference, hip circumference, and BMI between the two groups ( P  < 0.05). Before and after treatment, there was a significant difference in positive symptoms, negative symptoms, general symptoms, and PANSS in two groups, respectively ( P  < 0.05). The negative symptoms, general symptoms, PANSS, and TESS in the study group were lighter than that in the control group after treatment.
Conclusion


Liuyu decoction is not only beneficial to the treatment in body constitution of metabolic syndrome in qi stagnation and dampness obstruction but also beneficial to the improvement of such patients' mental symptoms and side effects.",2020,"Before and after treatment, there was a significant difference in positive symptoms, negative symptoms, general symptoms, and PANSS in two groups, respectively ( P  < 0.05).",['154 schizophrenics who met both the diagnostic criteria of metabolic syndrome and qi stagnation and dampness obstruction syndrome'],"['Traditional Chinese Medicine (TCM', 'Placebo', 'Liuyu decoction', 'placebo']","['negative symptoms, general symptoms, PANSS, and TESS', 'positive symptoms, negative symptoms, general symptoms, and PANSS', 'blood pressure, weight, waist circumference, hip circumference, blood glucose, glycosylated hemoglobin, high-density lipoprotein, low-density lipoprotein, triglyceride, and cholesterol', 'body weight, waist circumference, hip circumference, and BMI', 'blood pressure, blood sugar, glycosylated hemoglobin, cholesterol, TG, DHL, and LHL']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0159028', 'cui_str': 'General symptom'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}]",154.0,0.0174828,"Before and after treatment, there was a significant difference in positive symptoms, negative symptoms, general symptoms, and PANSS in two groups, respectively ( P  < 0.05).","[{'ForeName': 'Fengli', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Zhejiang Province Mental Health Center, Department of Psychiatry, Tongde Hospital of Zhejiang Province, Hangzhou, Zhejiang 310012, China.'}, {'ForeName': 'Zhibin', 'Initials': 'Z', 'LastName': 'Ren', 'Affiliation': 'Zhejiang Province Mental Health Center, Department of Psychiatry, Tongde Hospital of Zhejiang Province, Hangzhou, Zhejiang 310012, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'The Third Hospital of Huzhou City, Huzhou, Zhejiang 313000, China.'}, {'ForeName': 'Xiangming', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'Yiwu Mental Health Center, Yiwu, Zhejiang 322000, China.'}, {'ForeName': 'Naixin', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, Cancer Hospital Affiliated to Chinese Academy of Medical Sciences, Zhejiang Cancer Hospital, Hangzhou, Zhejiang 310000, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Jin', 'Affiliation': 'Zhejiang Province Mental Health Center, Department of Psychiatry, Tongde Hospital of Zhejiang Province, Hangzhou, Zhejiang 310012, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/5103046']
2222,32802249,"Efficacy of Fixed-combination Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Foam for Scalp Plaque Psoriasis: Additional Analysis of a Phase II, Randomized Clinical Study.","BACKGROUND:  There are a variety of treatment options currently available for plaque psoriasis affecting the scalp, yet scalp psoriasis remains one of the most frustrating and difficult-to-manage forms of the disease.  OBJECTIVE:  We investigated the efficacy of fixed-combination calcipotriene 0.005% plus betamethasone dipropionate 0.064% (Cal/BD) foam for the treatment of scalp psoriasis.  METHODS:  Additional (including  post-hoc ) analysis was conducted on data from a Phase II, randomized, double-blind, multicenter study of Cal/BD foam for the treatment of psoriasis vulgaris (NCT01536938). A total of 302 patients, ages 18 years or older, with psoriasis vulgaris of at least mild severity (scalp involvement of at least 10%) were included; 100, 101, and 101 patients were randomized to once-daily Cal/BD foam, Cal foam, or BD foam, respectively. Assessments included a severity score for lesion redness, scaliness, and plaque thickness, modified Psoriasis Area and Severity Index (mPASI) score, proportion of patients with reduction of 50 percent or greater in total sign score (TSS-50), and proportion of patients with at least a 75-percent reduction in mPASI score (mPASI-75).  RESULTS:  Patients achieved greater improvements in their scalp psoriasis with Cal/BD foam versus BD or Cal foam alone at Week 4 considering mPASI, mPASI-75, and TSS-50 outcomes. After four weeks of treatment, more patients receiving Cal/BD foam had a severity score for redness, scaliness, and thickness indicating ""none"" or ""mild"" versus BD foam or Cal foam alone. Improvements on the scalp appear to be consistent with those on the trunk and limbs.  CONCLUSION:  Scalp lesion severity improved considerably and rapidly with a four-week regimen of Cal/BD foam, suggesting that Cal/BD foam is an effective topical treatment option for scalp psoriasis.",2020,"After four weeks of treatment, more patients receiving Cal/BD foam had a severity score for redness, scaliness, and thickness indicating ""none"" or ""mild"" versus BD foam or Cal foam alone.","['302 patients, ages 18 years or older, with psoriasis vulgaris of at least mild severity (scalp involvement of at least 10%) were included; 100, 101, and 101 patients', 'scalp psoriasis']","['Fixed-combination Calcipotriene', 'fixed-combination calcipotriene 0.005% plus betamethasone dipropionate', 'Betamethasone Dipropionate']","['severity score for lesion redness, scaliness, and plaque thickness, modified Psoriasis Area and Severity Index (mPASI) score, proportion of patients with reduction of 50 percent or greater in total sign score (TSS-50), and proportion of patients with at least a 75-percent reduction in mPASI score (mPASI-75', 'Scalp lesion severity', 'severity score for redness, scaliness, and thickness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0406326', 'cui_str': 'Scalp psoriasis'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}, {'cui': 'C4517389', 'cui_str': '0.005'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}]","[{'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0600327', 'cui_str': 'Toxic shock syndrome'}, {'cui': 'C2168629', 'cui_str': 'Lesion of scalp'}]",302.0,0.0989973,"After four weeks of treatment, more patients receiving Cal/BD foam had a severity score for redness, scaliness, and thickness indicating ""none"" or ""mild"" versus BD foam or Cal foam alone.","[{'ForeName': 'Dharm S', 'Initials': 'DS', 'LastName': 'Patel', 'Affiliation': 'Drs. Patel and Veverka are with LEO Pharma in Madison, New Jersey.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Veverka', 'Affiliation': 'Drs. Patel and Veverka are with LEO Pharma in Madison, New Jersey.'}, {'ForeName': 'Jes B', 'Initials': 'JB', 'LastName': 'Hansen', 'Affiliation': 'Drs. Patel and Veverka are with LEO Pharma in Madison, New Jersey.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Yamauchi', 'Affiliation': 'Drs. Patel and Veverka are with LEO Pharma in Madison, New Jersey.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Alonso-Llamazares', 'Affiliation': 'Drs. Patel and Veverka are with LEO Pharma in Madison, New Jersey.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': 'Drs. Patel and Veverka are with LEO Pharma in Madison, New Jersey.'}]",The Journal of clinical and aesthetic dermatology,[]
2223,32802264,Clinical and Microbiological Effects of Weekly Supragingival Irrigation with Aerosolized 0.5% Hydrogen Peroxide and Formation of Cavitation Bubbles in Gingival Tissues after This Irrigation: A Six-Month Randomized Clinical Trial.,"Introduction


The study investigated the effect of weekly supragingival irrigation with aerosolized 0.5% hydrogen peroxide (H 2 O 2 ) solution as a maintenance periodontal therapy on clinical and microbiological parameters in patients with chronic periodontitis. The other purpose was to investigate whether cavitation bubbles can penetrate not only into periodontitis-damaged tissues but also into  ex vivo  porcine healthy periodontal tissues.
Materials and Methods


The study included 35 systemically healthy patients with chronic periodontitis (CP). After nonsurgical periodontal debridement (NSPD), all patients were randomized into two groups: the Control group (NSDP alone,  n  = 18) and the Test group (NSDP plus supragingival irrigation,  n  = 17). Clinical (Approximal Plaque Index (API), Bleeding Index (BI), and Modified Gingival Index (MGI)) and microbiological (Polymerase Chain Reaction technology (using a micro-IDent® kit)) measurements were performed at the initial time point, 3 months, and 6 months after NSPD. The impact of supragingival irrigation on diseased gingival tissues of CP patients ( n  = 5) and on  ex vivo  porcine healthy gingival tissue samples ( n  = 3) was evaluated to estimate morphological changes in healthy and diseased gingival tissues.
Results


Morphological data revealed that supragingival irrigation caused the formation of cavitation bubbles in diseased gingival tissue of CP patients and in healthy porcine gingival tissues. The decrease in API, BI, and MGI scores after 6 months in the Test group significantly ( p  ≤ 0.01,  p  ≤ 0.05, and  p  ≤ 0.01, respectively) exceeded that in the Control group. Test group patients demonstrated a decrease in periodontal sites showing Pocket Probing Depth > 4 mm and, after 6 months, a statistically significant decrease in the proportion of periopathogenic bacteria.
Conclusion


The effectiveness of mechanical periodontal treatment combined with weekly supragingival irrigation with aerosolized 0.5% H 2 O 2  solution on clinical and microbiological parameters of periodontal tissues of periodontitis patients is reliably higher than that of mechanical periodontal debridement alone. It has been found that cavitation bubbles as a result of irrigation with the aerosolized 0.5% hydrogen peroxide solution can form not only in periodontal tissues of periodontitis patients but also in  ex vivo  porcine healthy gingival tissues.",2020,"Test group patients demonstrated a decrease in periodontal sites showing Pocket Probing Depth > 4 mm and, after 6 months, a statistically significant decrease in the proportion of periopathogenic bacteria.
","['diseased gingival tissues of CP patients ( n  = 5) and on  ex vivo  porcine healthy gingival tissue samples ( n  = 3', 'patients with chronic periodontitis', '35 systemically healthy patients with chronic periodontitis (CP', 'periodontitis patients']","['Control group (NSDP alone,  n  = 18) and the Test group (NSDP plus supragingival irrigation', 'mechanical periodontal debridement alone', 'nonsurgical periodontal debridement (NSPD', 'Aerosolized 0.5% Hydrogen Peroxide and Formation of Cavitation Bubbles', 'supragingival irrigation with aerosolized 0.5% hydrogen peroxide (H 2 O 2 ) solution', 'supragingival irrigation', 'aerosolized 0.5% hydrogen peroxide solution']","['Clinical (Approximal Plaque Index (API), Bleeding Index (BI), and Modified Gingival Index (MGI)) and microbiological (Polymerase Chain Reaction technology (using a micro-IDent® kit)) measurements', 'periodontal sites', 'API, BI, and MGI scores', 'formation of cavitation bubbles', 'proportion of periopathogenic bacteria']","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C1292533', 'cui_str': 'Tissue specimen'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C2936227', 'cui_str': 'Nonsurgical Periodontal Debridement'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C1510420', 'cui_str': 'Cavity'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002191', 'cui_str': 'alpha 1-Antitrypsin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C1510420', 'cui_str': 'Cavity'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",35.0,0.0181976,"Test group patients demonstrated a decrease in periodontal sites showing Pocket Probing Depth > 4 mm and, after 6 months, a statistically significant decrease in the proportion of periopathogenic bacteria.
","[{'ForeName': 'Gediminas', 'Initials': 'G', 'LastName': 'Žekonis', 'Affiliation': 'Department of Dental and Maxillofacial Orthopedics, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Šadzevičienė', 'Affiliation': 'Department of Dental and Oral Pathology, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Ingrida', 'Initials': 'I', 'LastName': 'Balnytė', 'Affiliation': 'Department of Histology and Embryology, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Viktorija', 'Initials': 'V', 'LastName': 'Noreikienė', 'Affiliation': 'Department of Dental and Maxillofacial Orthopedics, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Gaida Marija', 'Initials': 'GM', 'LastName': 'Šidlauskaitė', 'Affiliation': 'Joint Stock Company ""MediCA Klinika"", Lithuania.'}, {'ForeName': 'Eglė', 'Initials': 'E', 'LastName': 'Šadzevičiūtė', 'Affiliation': 'Department of Dental and Maxillofacial Orthopedics, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Žekonis', 'Affiliation': 'Department of Dental and Maxillofacial Orthopedics, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}]",Oxidative medicine and cellular longevity,['10.1155/2020/3852431']
2224,32802282,Comparison of Antibacterial Effects of Photodynamic Therapy and an Irrigation Activation System on Root Canals Infected With  Enterococcus faecalis : An In Vitro Study.,"Introduction:   Enterococcus faecalis  is a resistant bacterium which is the most abundant species in infected root canals. Photodynamic therapy (PDT) is a method for killing the bacteria with active Oxygen radicals generated in a photosensitizer when exposed to centralized light. Furthermore, as a new method of canal disinfection, a variety of irrigation activation systems have been introduced, one of which is GentleFile (GF) with rotary movements and spiral effects for antibacterial action. This study aimed to compare the effectiveness of the two mentioned methods when used with and without Sodium Hypochlorite in eliminating  E. faecalis  from infected root canals.  Methods:  Fifty-eight uniradicular teeth were randomly divided into 4 experimental groups of 14. Two specimens were selected for later scanning electron microscopy in order to screen the procedure steps. In each experimental group, 10 samples were selected to be treated with GF or PDT; 3 of them were selected as positive controls and the other one sample was chosen as a negative control. Experimental groups were as follows: (1) Irrigation activation system, (2) Irrigation activation system + sodium hypochlorite, (3) PDT, and (4) PDT+ sodium hypochlorite. The specimens were then cultured for a bacterial colony count.  Results:  The decrease in the bacterial count after the treatment with the irrigation activation system was 99.8% ( P  =0.011) and when the system was used with sodium hypochlorite, it was 100% ( P  =0.001). The antibacterial effect of PDT was 90.08% ( P  =0.011) and it was 99.7% when PDT was combined with sodium hypochlorite ( P  =0.011).  Conclusion:  All four methods can be administered as complementary methods in root canal disinfection. According to the results of disinfection in the experimental groups of current study it is concluded that integration of new technologies such as activation irrigation system or PDT in Combination with NaOCl ameliorates disinfection of root canal and can provide several advantages in the endodontic outcome.",2020,"The decrease in the bacterial count after the treatment with the irrigation activation system was 99.8% ( P  =0.011) and when the system was used with sodium hypochlorite, it was 100% ( P  =0.001).","['Methods:  Fifty-eight uniradicular teeth', 'Root Canals Infected With  Enterococcus faecalis ']","['1) Irrigation activation system, (2) Irrigation activation system + sodium hypochlorite, (3) PDT, and (4) PDT+ sodium hypochlorite', 'Photodynamic therapy (PDT', 'Photodynamic Therapy']","['bacterial count', 'antibacterial effect of PDT']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0085494', 'cui_str': 'Genus Enterococcus'}]","[{'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]","[{'cui': 'C0004618', 'cui_str': 'Bacterial count'}, {'cui': 'C0279516', 'cui_str': 'Antibacterial'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]",,0.0178107,"The decrease in the bacterial count after the treatment with the irrigation activation system was 99.8% ( P  =0.011) and when the system was used with sodium hypochlorite, it was 100% ( P  =0.001).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Asnaashari', 'Affiliation': 'Laser Application in Medical Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Niloufar', 'Initials': 'N', 'LastName': 'Kooshki', 'Affiliation': 'DDS, Laser Application in Medical Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Mahdi', 'Initials': 'MM', 'LastName': 'Salehi', 'Affiliation': ""Dental students' research committee, faculty of dentistry, Isfahan University of Medical Sciences, Isfahan, Iran.""}, {'ForeName': 'Saranaz', 'Initials': 'S', 'LastName': 'Azari-Marhabi', 'Affiliation': 'Laser Application in Medical Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hedieh', 'Initials': 'H', 'LastName': 'Amin Moghadassi', 'Affiliation': 'Research Assistant, Chronic Respiratory Diseases Research Center (CRDRC), National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences,Tehran, Iran.'}]",Journal of lasers in medical sciences,['10.34172/jlms.2020.41']
2225,32804212,Effect of Clinician Training in the Modular Approach to Therapy for Children vs Usual Care on Clinical Outcomes and Use of Empirically Supported Treatments: A Randomized Clinical Trial.,"Importance


The Modular Approach to Therapy for Children (MATCH) was developed to address the comorbidities common among clinically referred youth, with beneficial outcomes shown in 2 US randomized clinical trials, where it outperformed both usual clinical care and single disorder-specific treatments.
Objective


To determine whether MATCH training of clinicians would result in more use of empirically supported treatment (EST) and better clinical outcomes than usual care (UC) in the publicly funded, multidisciplinary context of New Zealand.
Design, Setting, and Participants


This multisite, single-blind, computer-randomized clinical effectiveness trial compared MATCH with UC in child and adolescent mental health services in 5 regions of New Zealand. Recruitment occurred from March 2014 to July 2015, and a 3-month follow-up assessment was completed by May 2016. Clinicians at participating child and adolescent mental health services were randomized (1:1) to undertake training in MATCH or to deliver UC, and young people with anxiety, depression, trauma-related symptoms, or disruptive behavior seeking treatment at child and adolescent mental health services were randomized (1:1) to receive MATCH or UC. Participants and research assistants were blind to allocation. Data analysis was performed from April 2016 to July 2017.
Interventions


MATCH comprises EST components for flexible management of common mental health problems. UC includes case management and psychological therapies. Both can include pharmacotherapy.
Main Outcomes and Measures


There were 3 primary outcomes: trajectory of change of clinical severity, as measured by weekly ratings on the Brief Problem Monitor (BPM); fidelity to EST content, as measured by audio recordings of therapy sessions coded using the Therapy Integrity in Evidence Based Interventions: Observational Coding System; and efficiency of service delivery, as measured by duration of therapy (days) and clinician time (minutes).
Results


The study included 65 clinicians (mean age, 38.7 years; range, 23.0-64.0 years; 54 female [83%]; MATCH, 32 clinicians; UC, 33 clinicians) and 206 young people (mean age, 11.2 years; range 7.0-14.0 years; 122 female [61%]; MATCH, 102 patients; UC, 104 patients). For the BPM total ratings for parents, there was a mean (SE) slope of -1.04 (0.14) (1-year change, -6.12) in the MATCH group vs -1.04 (0.10) (1-year change, -6.17) in the UC group (effect size, 0.00; 95% CI, -0.27 to 0.28; P = .96). For the BPM total for youths, the mean (SE) slope was -0.74 (0.15) (1-year change, -4.35) in the MATCH group vs -0.73 (0.10) (1-year change, -4.32) in the UC group (effect size, -0.02; 95% CI, -0.30 to 0.26; P = .97). Primary analyses (intention-to-treat) showed no difference in clinical outcomes or efficiency despite significantly higher fidelity to EST content in the MATCH group (58 coded sessions; mean [SD], 80.0% [20.0%]) than the UC group (51 coded sessions; mean [SD], 57.0% [32.0%]; F(1,108) = 23.0; P < .001). With regard to efficiency of service delivery, there were no differences in total face-to-face clinician time between the MATCH group (mean [SD], 806 [527] minutes) and the UC group (mean [SD], 677 [539] minutes) or the overall duration of therapy between the MATCH group (mean [SD], 167 [107 days]) and the UC group (mean [SD], 159 [107] days).
Conclusions and Relevance


MATCH significantly increased adherence to EST practices but did not improve outcomes or efficiency. The nonsuperiority of MATCH may be attributable to high levels of EST use in UC in New Zealand.
Trial Registration


Australian New Zealand Clinical Trials Registry Identifier: ACTRN12614000297628.",2020,"Primary analyses (intention-to-treat) showed no difference in clinical outcomes or efficiency despite significantly higher fidelity to EST content in the MATCH group (58 coded sessions; mean [SD], 80.0% [20.0%]) than the UC group (51 coded sessions; mean [SD], 57.0% [32.0%]; F(1,108) = 23.0; P < .001).","['young people with anxiety, depression, trauma-related symptoms, or disruptive behavior seeking treatment at child and adolescent mental health services', '65 clinicians (mean age, 38.7 years; range, 23.0-64.0 years; 54 female [83%]; MATCH, 32 clinicians; UC, 33 clinicians) and 206 young people (mean age, 11.2 years; range 7.0-14.0 years; 122 female [61%]; MATCH, 102 patients; UC, 104 patients', 'Children (MATCH', 'child and adolescent mental health services in 5 regions of New Zealand', 'Clinicians at participating child and adolescent mental health services']","['undertake training in MATCH or to deliver UC', 'MATCH with UC', 'MATCH or UC', 'Clinician Training']","['overall duration of therapy', 'total face-to-face clinician time', 'mean (SE) slope', 'BPM total ratings', 'change of clinical severity, as measured by weekly ratings on the Brief Problem Monitor (BPM); fidelity to EST content, as measured by audio recordings of therapy sessions coded using the Therapy Integrity in Evidence Based Interventions: Observational Coding System; and efficiency of service delivery, as measured by duration of therapy (days) and clinician time (minutes', 'fidelity to EST content']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0474416', 'cui_str': 'Disruptive behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517531', 'cui_str': '11.2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0454766', 'cui_str': 'Regions of New Zealand'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}]",65.0,0.108387,"Primary analyses (intention-to-treat) showed no difference in clinical outcomes or efficiency despite significantly higher fidelity to EST content in the MATCH group (58 coded sessions; mean [SD], 80.0% [20.0%]) than the UC group (51 coded sessions; mean [SD], 57.0% [32.0%]; F(1,108) = 23.0; P < .001).","[{'ForeName': 'Sally N', 'Initials': 'SN', 'LastName': 'Merry', 'Affiliation': 'Department of Psychological Medicine, School of Medicine, FMHS University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Hopkins', 'Affiliation': 'Department of Psychological Medicine, School of Medicine, FMHS University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Mathijs F G', 'Initials': 'MFG', 'LastName': 'Lucassen', 'Affiliation': 'Department of Psychological Medicine, School of Medicine, FMHS University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Stasiak', 'Affiliation': 'Department of Psychological Medicine, School of Medicine, FMHS University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Weisz', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, Massachusetts.'}, {'ForeName': 'Christopher M A', 'Initials': 'CMA', 'LastName': 'Frampton', 'Affiliation': 'Department of Psychological Medicine, Christchurch School of Medicine, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'Sarah Kate', 'Initials': 'SK', 'LastName': 'Bearman', 'Affiliation': 'Department of Educational Psychology, The University of Texas at Austin, Austin.'}, {'ForeName': 'Ana M', 'Initials': 'AM', 'LastName': 'Ugueto', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, McGovern Medical School, The University of Texas Health Science Center at Houston, Houston.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Herren', 'Affiliation': 'Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, Rhode Island.'}, {'ForeName': 'Ainsleigh', 'Initials': 'A', 'LastName': ""Cribb-Su'a"", 'Affiliation': 'Department of Psychological Medicine, School of Medicine, FMHS University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Kingi-Uluave', 'Affiliation': 'Le Va, Harakeke House, Manukau, Auckland, New Zealand.'}, {'ForeName': 'Jik', 'Initials': 'J', 'LastName': 'Loy', 'Affiliation': 'Infant, Child and Adolescent Mental Health Services, Waikato District Health Board, Hamilton, New Zealand.'}, {'ForeName': 'Morgyn', 'Initials': 'M', 'LastName': 'Hartdegen', 'Affiliation': 'Department of Psychological Medicine, School of Medicine, FMHS University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Crengle', 'Affiliation': 'Department of Preventive and Social Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.11799']
2226,32804248,Locking versus non-locking plates in fixation of extra-articular distal humerus fracture: a randomized controlled study.,"INTRODUCTION


Studies have shown that the use of nonlocking (reconstruction) plates in fixing distal humerus fractures may not yield stable fixation which therefore requires long immobilization and suboptimal functional results. There are reports showing that locking plates are biomechanically superior to nonlocking plates. The aim of this study was to compare elbow functional outcomes between locking and nonlocking plates in fixation of distal humerus fractures.
METHODS


A single-centre, randomized control study was conducted at an academic level 1 trauma centre. A total of 60 patients with type 13-A fracture (AO/OTA classification) were randomized into two equal groups, locking plates group, and nonlocking plates group. The primary outcome measure was the Mayo elbow performance score (MEPS) at one year. Secondary outcomes measures were elbow flexion/extension arc, union, operative time, and complications (e.g., infection, heterotrophic ossification).
RESULTS


The Mayo Elbow Performance Score (MEPS) at one year was 88 ± 10.1 in locking plates group and 75.8 ± 12.8 in nonlocking plates group. The difference was found to be statically significant (P value = 0.01). Elbow flexion/extension arc of motion at one year was 116° ± 15° in locking plates group and 113° ± 28° in nonlocking plates. The difference was not found to be statistically significant (P value = 0.17).
CONCLUSION


Both implants yield similar results, with locking plates showing slightly better clinical scores.",2020,The Mayo Elbow Performance Score (MEPS) at one year was 88 ± 10.1 in locking plates group and 75.8 ± 12.8 in nonlocking plates group.,"['A single-centre, randomized control study was conducted at an academic level 1 trauma centre', 'extra-articular distal humerus fracture', '60 patients with type 13-A fracture (AO/OTA classification']","['locking plates group, and nonlocking plates group', 'Elbow flexion/extension arc of motion at one year was\xa0116° ± 15', 'nonlocking (reconstruction) plates', 'locking and nonlocking plates', 'Locking versus non-locking plates']","['elbow flexion/extension arc, union, operative time, and complications (e.g., infection, heterotrophic ossification', 'elbow functional outcomes', 'Mayo Elbow Performance Score (MEPS', 'Mayo elbow performance score (MEPS']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0456947', 'cui_str': 'Level 1'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0588211', 'cui_str': 'Bone structure of distal humerus'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0069299', 'cui_str': 'ochratoxin A'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C4517541', 'cui_str': '116'}]","[{'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}, {'cui': 'C0001857', 'cui_str': 'AIDS related complex'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0449834,The Mayo Elbow Performance Score (MEPS) at one year was 88 ± 10.1 in locking plates group and 75.8 ± 12.8 in nonlocking plates group.,"[{'ForeName': 'Sherif', 'Initials': 'S', 'LastName': 'Galal', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Cairo University, Cairo, P. O 11559, Egypt. Sherif.Galal@kasralainy.edu.eg.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Mattar', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Cairo University, Cairo, P. O 11559, Egypt.'}, {'ForeName': 'Alaa Mohy Eldin', 'Initials': 'AME', 'LastName': 'Solyman', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Cairo University, Cairo, P. O 11559, Egypt.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Ezzat', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Cairo University, Cairo, P. O 11559, Egypt.'}]",International orthopaedics,['10.1007/s00264-020-04770-z']
2227,32804266,"The effect of verbal feedback, video feedback, and self-assessment on laparoscopic intracorporeal suturing skills in novices: a randomized trial.","BACKGROUND


Laparoscopic skill acquisition involves a steep learning curve and laparoscopic suturing is an exceptionally challenging task. By improving the way feedback is given, trainees can learn these skills more effectively. This study aims to establish the most effective form of structured feedback on laparoscopic suturing skill acquisition in novices, by comparing the effects of expert verbal feedback, video review with expert feedback (video feedback), and video review with self-assessment.
METHODS


A prospective randomized blinded trial comparing verbal feedback, video feedback, and self-assessment. Novices in laparoscopic surgery were tasked with performing laparoscopic suturing with intracorporeal knot tying. Time was given for practice, and pre- and post-feedback assessments were undertaken. Suturing performance was measured using a task-specific checklist and global ratings. A post-study questionnaire was used to measure participant-perceived confidence, knowledge, and experience levels.
RESULTS


Fifty-one participants were randomized and allocated equally into the three groups. Performance in all three groups improved significantly from baseline. Video feedback had the largest improvement margin with checklist and global score improvements of 17.1% (± 9.9%) and 14.7% (± 9.3%), respectively. Performance improvements between groups were statistically significant in the global components (p = 0.004) but not the checklist components (p = 0.186). Global score improvement was significantly better in the video feedback group but was statistically insignificant between the self-assessment and verbal feedback groups. Questionnaire responses demonstrated positive results in confidence, knowledge, and experience levels, across all three study groups, with no differences between the groups (p > 0.05).
CONCLUSION


Structured video feedback facilitates reflection and self-directed learning, which improves the ability to develop proficiency in surgical skills. Combining both self-assessment and video feedback may be beneficial over verbal feedback alone due to the advantages of video review. These techniques should therefore be considered for implementation into surgical education curricula.",2020,Global score improvement was significantly better in the video feedback group but was statistically insignificant between the self-assessment and verbal feedback groups.,"['novices', 'Fifty-one participants']","['verbal feedback, video feedback, and self-assessment', 'laparoscopic intracorporeal suturing skills', 'expert verbal feedback, video review with expert feedback (video feedback), and video review with self-assessment', 'laparoscopic suturing with intracorporeal knot tying', 'laparoscopic surgery']","['Global score improvement', 'global components', 'confidence, knowledge, and experience levels', 'Suturing performance', 'Performance', 'Performance improvements']",[],"[{'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0560032', 'cui_str': 'knot'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]",51.0,0.0475913,Global score improvement was significantly better in the video feedback group but was statistically insignificant between the self-assessment and verbal feedback groups.,"[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Halim', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, Charterhouse Square, London, UK. jonat17455@outlook.com.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Jelley', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, Charterhouse Square, London, UK.'}, {'ForeName': 'Ningning', 'Initials': 'N', 'LastName': 'Zhang', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, Charterhouse Square, London, UK.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Ornstein', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, Charterhouse Square, London, UK.'}, {'ForeName': 'Bijendra', 'Initials': 'B', 'LastName': 'Patel', 'Affiliation': 'Barts Cancer Institute, Queen Mary University of London, Charterhouse Square, London, UK.'}]",Surgical endoscopy,['10.1007/s00464-020-07871-3']
2228,32804268,Pulmonary recruitment can reduce residual pneumoperitoneum and shoulder pain in conventional laparoscopic procedures: results of a randomized controlled trial.,"BACKGROUND


This study is aimed to evaluate the pulmonary recruitment maneuver as a means to effectively reduce residual pneumoperitoneum and postoperative shoulder pain in patients undergoing conventional laparoscopic procedures and compare it to the instillation of intraperitoneal anesthetics.
METHODS


Patients undergoing laparoscopic cholecystectomy, appendectomy or hernioplasty were randomized into two groups: pulmonary recruitment maneuver (PRM) and intraperitoneal anesthetic instillation (IAI). Six hours after surgery patients were asked to fill out a visual analog scale to identify shoulder pain and a chest X-ray was taken. Groups were analyzed for incidence of residual pneumoperitoneum and shoulder pain as well as for volume of residual subdiaphragmatic gas and intensity of pain.
RESULTS


A total of 84 patients (42 per group) were included in the study. Patients in the PRM group had a lower incidence of subdiaphragmatic gas present in the chest X-ray (29% vs 55%) p = 0.01 and less volume of residual pneumoperitoneum (mean difference -.31(95%CI -7.36, 0.72), p = 0.02). They also were half as likely to present shoulder pain (24% vs 50%) p = 0.01 and showed less pain intensity than those in the IAI group (mean difference -2.04(95%CI - 3.25, - 0.84), p = 0.000). The risk of presenting shoulder pain when residual pneumoperitoneum was present showed an RR = 11.1, p = 0.0001 in the PRM group and an RR = 8.3, p = 0.000 in the IAI group. The volume of subdiaphragmatic gas was positively correlated with the intensity of shoulder pain (r = 0.54, p = 0.000).
CONCLUSIONS


The pulmonary recruitment maneuver is effective in reducing the incidence and volume of residual pneumoperitoneum, as well as the incidence and intensity of shoulder pain in patients undergoing conventional laparoscopic procedures.",2020,"They also were half as likely to present shoulder pain (24% vs 50%) p = 0.01 and showed less pain intensity than those in the IAI group (mean difference -2.04(95%CI - 3.25, - 0.84), p = 0.000).","['Patients undergoing', 'conventional laparoscopic procedures', 'patients undergoing conventional laparoscopic procedures', '84 patients (42 per group) were included in the study', 'patients undergoing']","['pulmonary recruitment maneuver (PRM) and intraperitoneal anesthetic instillation (IAI', 'laparoscopic cholecystectomy, appendectomy or hernioplasty', 'PRM', 'conventional laparoscopic procedures']","['residual pneumoperitoneum and shoulder pain', 'volume of subdiaphragmatic gas', 'intensity of shoulder pain', 'pain intensity', 'risk of presenting shoulder pain', 'volume of residual pneumoperitoneum', 'residual pneumoperitoneum and shoulder pain as well as for volume of residual subdiaphragmatic gas and intensity of pain', 'shoulder pain', 'subdiaphragmatic gas']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0442120', 'cui_str': 'Intraperitoneal'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",84.0,0.0750097,"They also were half as likely to present shoulder pain (24% vs 50%) p = 0.01 and showed less pain intensity than those in the IAI group (mean difference -2.04(95%CI - 3.25, - 0.84), p = 0.000).","[{'ForeName': 'Denzil', 'Initials': 'D', 'LastName': 'Garteiz-Martínez', 'Affiliation': 'Faculty of Health Sciences, Universidad Anáhuac / Hospital Angeles Lomas, Vialidad de la Barranca s/n, C 410, Valle de Las Palmas, Huixquilucan, Estado de México, 52774, México. denzilgarteiz@yahoo.com.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Rodríguez-Ayala', 'Affiliation': 'Faculty of Health Sciences, Universidad Anáhuac / Hospital Angeles Lomas, Vialidad de la Barranca s/n, C 410, Valle de Las Palmas, Huixquilucan, Estado de México, 52774, México.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Weber-Sánchez', 'Affiliation': 'Faculty of Health Sciences, Universidad Anáhuac / Hospital Angeles Lomas, Vialidad de la Barranca s/n, C 410, Valle de Las Palmas, Huixquilucan, Estado de México, 52774, México.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bravo-Torreblanca', 'Affiliation': 'Faculty of Health Sciences, Universidad Anáhuac / Hospital Angeles Lomas, Vialidad de la Barranca s/n, C 410, Valle de Las Palmas, Huixquilucan, Estado de México, 52774, México.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Carbó-Romano', 'Affiliation': 'Faculty of Health Sciences, Universidad Anáhuac / Hospital Angeles Lomas, Vialidad de la Barranca s/n, C 410, Valle de Las Palmas, Huixquilucan, Estado de México, 52774, México.'}]",Surgical endoscopy,['10.1007/s00464-020-07881-1']
2229,32798357,Clinical evaluation of the use of laryngeal tube verses laryngeal mask airway for out-of-hospital cardiac arrest by paramedics in Singapore.,"INTRODUCTION


It is unclear which advanced airway device has better placement success and fewer adverse events in out-of-hospital cardiac arrests (OHCAs). This study aimed to evaluate the efficacy of the VBM laryngeal tube (LT) against the laryngeal mask airway (LMA) in OHCAs managed by emergency ambulances in Singapore.
METHODS


This was a real-world, prospective, cluster-randomised crossover study. All OHCA patients above 13 years old who were suitable for resuscitation were randomised to receive either LT or LMA. The primary outcome was placement success. Per-protocol analysis was performed and association between outcomes and airway device group was compared using multivariate binomial logistic regression analysis.
RESULTS


Of 965 patients with OHCAs from March 2016 to January 2018, 905 met the inclusion criteria, of which 502 (55.5%) were randomised to receive LT while 403 (44.5%) were randomised to receive LMA. Only 174 patients in the LT group actually received the device due to noncompliance. Placement success for LT was lower than for LMA (adjusted odds ratio [OR] 0.52, 95% confidence interval [CI] 0.31-0.90). Complications were more likely when using LT (OR 2.82,0 95% CI 1.64-4.86). Adjusted OR for prehospital return of spontaneous circulation (ROSC) was similar in both groups. A modified intention-to-treat analysis showed similar outcomes to the per-protocol analysis between the groups.
CONCLUSION


LT was associated with poorer placement success and higher complication rates than LMA. The likelihood of prehospital ROSC was similar between the two groups. Familiarity bias and a low compliance rate to the LT were the main limitations of this study.",2020,"Complications were more likely when using LT (OR 2.82,0 95% CI 1.64-4.86).","['All OHCA patients above 13 years old who were suitable for resuscitation', 'OHCAs managed by emergency ambulances in Singapore', '965 patients with OHCAs from March 2016 to January 2018, 905 met the inclusion criteria, of which 502 (55.5%) were randomised to receive LT while 403 (44.5', 'out-of-hospital cardiac arrest by paramedics in Singapore']","['VBM laryngeal tube (LT) against the laryngeal mask airway (LMA', 'laryngeal tube verses laryngeal mask airway', 'LMA', 'LT or LMA']","['likelihood of prehospital ROSC', 'complication rates', 'placement success', 'Complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0002422', 'cui_str': 'Ambulance'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0013963', 'cui_str': 'Paramedic'}]","[{'cui': 'C0078140', 'cui_str': 'VBM protocol'}, {'cui': 'C0023078', 'cui_str': 'Laryngeal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal mask'}, {'cui': 'C0042553', 'cui_str': 'Versed'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",965.0,0.183024,"Complications were more likely when using LT (OR 2.82,0 95% CI 1.64-4.86).","[{'ForeName': 'Jing Jing', 'Initials': 'JJ', 'LastName': 'Chan', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore.'}, {'ForeName': 'Zi Xin', 'Initials': 'ZX', 'LastName': 'Goh', 'Affiliation': 'Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Zhi Xiong', 'Initials': 'ZX', 'LastName': 'Koh', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore.'}, {'ForeName': 'Janice Jie Er', 'Initials': 'JJE', 'LastName': 'Soo', 'Affiliation': 'Ministry of Health Holdings, Singapore.'}, {'ForeName': 'Jes', 'Initials': 'J', 'LastName': 'Fergus', 'Affiliation': 'Medical Department, Singapore Civil Defence Force, Singapore.'}, {'ForeName': 'Yih Yng', 'Initials': 'YY', 'LastName': 'Ng', 'Affiliation': 'Home Team, Ministry of Home Affairs, Singapore.'}, {'ForeName': 'John Carson', 'Initials': 'JC', 'LastName': 'Allen', 'Affiliation': 'Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Marcus Eng Hock', 'Initials': 'MEH', 'LastName': 'Ong', 'Affiliation': 'Department of Emergency Medicine, Singapore General Hospital, Singapore.'}]",Singapore medical journal,['10.11622/smedj.2020119']
2230,32798360,Beyond diabetes mellitus: role of metformin in non-muscle invasive bladder cancer.,"INTRODUCTION


Usage of metformin is associated with improved survival in lung, breast and prostate cancer, and metformin has been shown to inhibit cancer cell growth and proliferation in in vitro studies. Given the lack of clinical data on metformin use in patients with bladder cancer, we aimed to evaluate the role of metformin in their oncological outcomes.
METHODS


Medication use from a prospectively maintained database of 122 patients with non-muscle invasive bladder cancer treated with intravesical Bacille Calmette-Guerin (BCG), who were recruited under a randomised, double-blinded, controlled clinical trial, was collected and analysed. Kaplan-Meier curves were used to assess overall survival (OS) and disease-specific survival (DSS).
RESULTS


At a median follow-up duration of 102 (range 3-357) months, 53 (43.4%) patients experienced disease recurrence and 21 (17.2%) experienced disease progression. There was no significant difference in mortality between patients with diabetes mellitus and those without. There was significant difference in OS among patients without diabetes mellitus, patients with diabetes mellitus on metformin and patients with diabetes mellitus not on metformin (p = 0.033); patients with diabetes mellitus on metformin had the best prognosis. Metformin use was associated with significantly lower DSS (p = 0.042). Other oral hypoglycaemic agents, insulin or statins were not associated with disease recurrences or progression.
CONCLUSION


Metformin use was associated with improved oncological outcomes in patients with non-muscle invasive bladder cancer treated with intravesical BCG. Prospective studies with larger patient populations are needed to validate the role of metformin as potential therapy for bladder cancer.",2020,Metformin use was associated with improved oncological outcomes in patients with non-muscle invasive bladder cancer treated with intravesical BCG.,"['patients with bladder cancer', 'patients with non-muscle invasive bladder cancer treated with', 'patients with diabetes mellitus', '122 patients with non-muscle invasive bladder cancer treated with', 'non-muscle invasive bladder cancer', 'Beyond diabetes mellitus']","['Metformin', 'intravesical Bacille Calmette-Guerin (BCG', 'metformin', 'intravesical BCG']","['OS', 'disease recurrence', 'disease progression', 'lower DSS', 'oncological outcomes', 'overall survival (OS) and disease-specific survival (DSS', 'mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0679254', 'cui_str': 'Disease recurrence'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",122.0,0.037749,Metformin use was associated with improved oncological outcomes in patients with non-muscle invasive bladder cancer treated with intravesical BCG.,"[{'ForeName': 'Ziting', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, National University Hospital, Singapore.'}, {'ForeName': 'Wilson Ying Fa', 'Initials': 'WYF', 'LastName': 'Ong', 'Affiliation': 'Department of Urology, National University Hospital, Singapore.'}, {'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Tong', 'Affiliation': 'Department of Urology, National University Hospital, Singapore.'}, {'ForeName': 'Jen-Hwei', 'Initials': 'JH', 'LastName': 'Sng', 'Affiliation': 'Department of Urology, National University of Singapore, Singapore.'}, {'ForeName': 'Raman Mani', 'Initials': 'RM', 'LastName': 'Lata', 'Affiliation': 'Department of Urology, National University Hospital, Singapore.'}, {'ForeName': 'Ratha', 'Initials': 'R', 'LastName': 'Mahendran', 'Affiliation': 'Department of Urology, National University of Singapore, Singapore.'}, {'ForeName': 'Esuvaranathan', 'Initials': 'E', 'LastName': 'Kesavan', 'Affiliation': 'Department of Urology, National University Hospital, Singapore.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Chiong', 'Affiliation': 'Department of Urology, National University Hospital, Singapore.'}]",Singapore medical journal,['10.11622/smedj.2020121']
2231,32798463,Immediate vs Delayed Stenting in ST-Elevation Myocardial Infarction: Rationale and Design of the International PRIMACY Bayesian Randomized Controlled Trial.,"BACKGROUND


Primary percutaneous coronary intervention is used to restore blood flow in the infarct-related coronary artery, followed by immediate stenting to prevent reocclusion. Stents implanted in thrombus-laden arteries cause distal embolization, which paradoxically impairs myocardial reperfusion and ventricular function. Whether a strategy of delayed stenting improves outcomes in patients with acute ST-elevation myocardial infarction (STEMI) is uncertain.
METHODS


The Primary Reperfusion Secondary Stenting (PRIMACY) is a Bayesian prospective, randomized, open-label, blinded end point trial in which delayed vs immediate stenting in patients with STEMI were compared for prevention of cardiovascular death, nonfatal myocardial infarction, heart failure, or unplanned target vessel revascularization at 9 months. All participants were immediately reperfused, but those assigned to the delayed arm underwent stenting after an interval of 24 to 48 hours. This interval was bridged with antithrombin therapy to reduce thrombus burden. In the principal Bayesian hierarchical random effects analysis, data from exchangeable trials will be combined into a study prior and updated with PRIMACY into a posterior probability of efficacy.
RESULTS


A total of 305 participants were randomized across 15 centres in France and Canada between April 2014 and September 2017. At baseline, the median age of participants was 59 years, 81% were male, and 3% had a history of percutaneous coronary intervention. Results from PRIMACY will be updated from the patient-level data of 1568 participants enrolled in the Deferred Stent Trial in STEMI (DEFER; United Kingdom), Minimalist Immediate Mechanical Intervention (MIMI; France), Danish Trial in Acute Myocardial Infarction-3 (DANAMI-3; Denmark), and Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST Segment-Elevation Myocardial Infarction (INNOVATION, South Korea) trials.
CONCLUSIONS


We expect to clarify whether delayed stenting can safely reduce the occurrence of adverse cardiovascular end points compared with immediate stenting in patients with STEMI.",2020,We expect to clarify whether delayed stenting can safely reduce the occurrence of adverse cardiovascular end points compared with immediate stenting in patients with STEMI.,"['patients with acute ST-elevation myocardial infarction (STEMI', 'median age of participants was 59 years, 81% were male, and 3% had a history of percutaneous coronary intervention', 'Patients With ST Segment-Elevation Myocardial Infarction (INNOVATION, South Korea) trials', 'patients with STEMI', '1568 participants enrolled in the Deferred Stent Trial in STEMI (DEFER; United Kingdom', 'ST-Elevation Myocardial Infarction', '305 participants were randomized across 15 centres in France and Canada between April 2014 and September 2017']","['Immediate Stent Implantation Versus Deferred Stent Implantation', 'antithrombin therapy', 'delayed stenting', 'Immediate vs Delayed Stenting']","['cardiovascular death, nonfatal myocardial infarction, heart failure, or unplanned target vessel revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1320647', 'cui_str': 'History of percutaneous coronary intervention'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C4517703', 'cui_str': '305'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0003438', 'cui_str': 'Antithrombin III'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",305.0,0.36388,We expect to clarify whether delayed stenting can safely reduce the occurrence of adverse cardiovascular end points compared with immediate stenting in patients with STEMI.,"[{'ForeName': 'E Marc', 'Initials': 'EM', 'LastName': 'Jolicoeur', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montréal, Québec, Canada. Electronic address: marc.jolicoeur@icm-mhi.org.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Dendukuri', 'Affiliation': 'Centre for Outcomes Research, McGill University Health Centre-Research Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Belisle', 'Affiliation': 'Montreal Health Innovation Coordination Center, Montreal, Quebec, Canada.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Range', 'Affiliation': 'Department of Cardiology, Les Hôpitaux de Chartres, Euret-Loir, France.'}, {'ForeName': 'Geraud', 'Initials': 'G', 'LastName': 'Souteyrand', 'Affiliation': 'CHU-Clermont Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Bouisset', 'Affiliation': 'Toulouse Rangueil University Hospital (CHU), Toulouse, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Zemour', 'Affiliation': 'Centre Hospitalier Pierre Nouveau Cannes, Cannes, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Delarche', 'Affiliation': 'Centre Hospitalier de Pau, Pau, France.'}, {'ForeName': 'Brahim', 'Initials': 'B', 'LastName': 'Harbaoui', 'Affiliation': 'Hôpital Croix-Rousse and Hôpital Lyon Sud, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Schampaert', 'Affiliation': 'Hopital Sacre-Coeur, Interventional Cardiology, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kouz', 'Affiliation': 'Centre Hospitalier Régional de Lanaudiere, Joliette, Quebec, Canada.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cayla', 'Affiliation': 'Centre Hospitalier Universitaire Nimes, Université de Montpellier, Nimes, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roubille', 'Affiliation': 'PhyMedExp, Université de Montpellier, INSERM, CNRS, Cardiology Department, CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Boueri', 'Affiliation': 'Centre Hospitalier de Bastia, Bastia, France.'}, {'ForeName': 'Samer', 'Initials': 'S', 'LastName': 'Mansour', 'Affiliation': ""Centre Hospitalier Universitaire de l'Université de Montréal, Université de Montréal, Montreal, Quebec, Canada.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Marcaggi', 'Affiliation': 'Department of Cardiology, Centre Hospitalier de Vichy, Vichy, France.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Tardif', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McGillion', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Tanguay', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Brophy', 'Affiliation': 'McGill University Health Centre, Division of Cardiology, Montreal, Quebec, Canada.'}, {'ForeName': 'Cheol Woong', 'Initials': 'CW', 'LastName': 'Yu', 'Affiliation': 'Korea University Anam Hospital, Cardiovascular Center (Interventional Cardiology), Seoul, Republic of Korea.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'BHF Glasgow Cardiovascular Research Center, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow; and West of Scotland Heart and Lung Center, Golden Jubilee National Hospital, Dunbartonshire, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carrick', 'Affiliation': 'University Hospital Hairmyres, East Kilbride, Glasgow, United Kingdom.'}, {'ForeName': 'Dan Eik', 'Initials': 'DE', 'LastName': 'Høfsten', 'Affiliation': 'Rigshospitalet-Copenhagen University Hospital, Department of Cardiology, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Rigshospitalet-Copenhagen University Hospital, Department of Cardiology, Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kober', 'Affiliation': 'Rigshospitalet-Copenhagen University Hospital, Department of Cardiology, Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Kelbæk', 'Affiliation': 'Dept of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Loic', 'Initials': 'L', 'LastName': 'Belle', 'Affiliation': 'Hospital of Annecy, Centre Hospitalier Annecy Genevois, Annecy, France.'}]",The Canadian journal of cardiology,['10.1016/j.cjca.2020.01.019']
2232,32798481,COVID-19 trial co-enrolment and subsequent enrolment.,,2020,,[],[],[],[],[],[],,0.0447908,,"[{'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Gertner', 'Affiliation': 'Section of Rheumatology, Regions Hospital, St Paul, MN 55101, USA; Health Partners Institute, Bloomington, MN, USA; Division of Rheumatology, University of Minnesota Medical School, Minneapolis, MN, USA. Electronic address: elie.x.gertner@healthpartners.com.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31537-3']
2233,32798558,Dexmedetomidine alleviates non-ventilation associated lung injury via modulating immunology phenotypes of macrophages.,"AIMS


We aimed to evaluate the effect of Dexmedetomidine (Dex) on immunology function of macrophages and inflammatory reactions in non-ventilated lung tissues from both humans and rats.
MAIN METHODS


Patients scheduled for lung lobectomy were randomly assigned to traditional anesthesia group or Dex anesthesia group, 15 subjects in each group. CD68, CD86 and CD206 were used to mark activate and polarized macrophages using immunofluorescence staining in human lung tissues. Sprague-Dawley rats were used to set lung injury model and randomly divided into Control group, one-lung ventilation group (CLI group) and CLI + Dex group. Lung tissues and bronchoalveolar lavage fluid (BALF) from non-ventilated lungs were collected. The acquired lung tissues were subjected to hematoxylin-eosin (H&E) staining and the inflammatory cells in BALF were calculated. Levels of cytokines and chemokines were detected by enzyme-linked immunosorbent assays (ELISA).
KEY FINDINGS


Results from humans showed that anesthesia with Dex decreased the number of both CD68 positive cells and CD86 positive cells and down-regulated level of pro-inflammatory cytokines tumor necrosis factor-α (TNF-α) and monocyte chemotactic protein 1 (MCP-1) in human lung. Results from rats demonstrated that treatment with Dex reversed the increased inflammatory cells in lung and the increased levels of TNF-α, interleukin-1β (IL-β), MCP-1 and chemokine (C-X-C motif) ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
SIGNIFICANCE


This study showed that Dex modulated the activation and immunological function of macrophages in non-ventilated lung and revealed a protective role in collapsed lung injury.",2020,"ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
","['Patients scheduled for lung lobectomy', 'non-ventilated lung tissues from both humans and rats']","['traditional anesthesia group or Dex anesthesia', 'Dexmedetomidine (Dex', 'Control group, one-lung ventilation group (CLI group) and CLI\u202f+\u202fDex group', 'Dexmedetomidine', 'Dex']","['inflammatory cells in lung and the increased levels of TNF-α, interleukin-1β (IL-β), MCP-1 and chemokine (C-X-C motif', 'Levels of cytokines and chemokines', 'immunology function of macrophages and inflammatory reactions', 'Lung tissues and bronchoalveolar lavage fluid (BALF', 'number of both CD68 positive cells and CD86 positive cells and down-regulated level of pro-inflammatory cytokines tumor necrosis factor-α (TNF-α) and monocyte chemotactic protein 1 (MCP-1', 'anti-inflammatory cytokine interleukin-10 (IL-10']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C1453673', 'cui_str': 'CLU protein, human'}]","[{'cui': 'C0440752', 'cui_str': 'Inflammatory cell'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0024432', 'cui_str': 'Macrophage'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0819757', 'cui_str': 'Structure of parenchyma of lung'}, {'cui': 'C0006279', 'cui_str': 'Bronchoalveolar lavage fluid sample'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}, {'cui': 'C0527903', 'cui_str': 'Lymphocyte antigen CD86'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",15.0,0.0272658,"ligand 1 (CXCL1) resulted from non-ventilation; Dex increased the anti-inflammatory cytokine interleukin-10 (IL-10) in BALF from non-ventilated lung.
","[{'ForeName': 'Qiying', 'Initials': 'Q', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China. Electronic address: shenqiying-yy@163.com.'}, {'ForeName': 'Guanghong', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China; Department of Anesthesiology, the Fourth Affiliated Hospital of Anhui Medical University, Hefei 230000, China.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Yongqi', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Lv', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China.'}, {'ForeName': 'Xuesheng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, the First Affiliated Hospital of Anhui Medical University, Hefei 230032, China. Electronic address: liuxuesheng@ahmu.edu.cn.'}]",Life sciences,['10.1016/j.lfs.2020.118249']
2234,32798689,TBCRC 030: A phase II study of preoperative cisplatin vs. paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker.,"BACKGROUND


Cisplatin and paclitaxel are active in triple-negative breast cancer (TNBC). Despite different mechanisms of action, effective predictive biomarkers to preferentially inform drug selection have not been identified. The homologous recombination deficiency (HRD) assay (Myriad Genetics, Inc.) detects impaired double-strand DNA break repair and may identify patients with BRCA1/2-proficient tumors that are sensitive to DNA-targeting therapy. The primary objective of TBCRC 030 was to detect an association of HRD with pathologic response (RCB-0/1) to single-agent cisplatin or paclitaxel.
PATIENTS AND METHODS


This prospective phase II study randomized patients with germline BRCA1/2 wild-type/unknown stage I-III TNBC to 12 weeks of preoperative cisplatin or paclitaxel. The HRD assay was performed on baseline tissue; positive HRD was defined as a score >33. Crossover to an alternative chemotherapy was offered if there was inadequate response.
RESULTS


139 patients were evaluable for response, including 88 (63.3%) who had surgery at 12 weeks and 51 (36.7%) who crossed over due to inadequate clinical response. HRD results were available for 104 tumors (74.8%); 74 (71.1%) were HRD positive. RCB-0/1 rate was 26.4% with cisplatin and 22.3% with paclitaxel. No significant association was observed between HRD score and RCB response to either cisplatin (odds ratio [OR] for RCB 0/1 if HRD positive 2.22 [95% CI: 0.39-23.68]), or paclitaxel (OR for RCB 0/1 if HRD positive 0.90 [95% CI: 0.19-4.95]). There was no evidence of an interaction between HRD and pathologic response to chemotherapy.
CONCLUSIONS


In this prospective preoperative trial in TNBC, HRD was not predictive of pathologic response. Tumors were similarly responsive to preoperative paclitaxel or cisplatin chemotherapy.",2020,"RESULTS


139 patients were evaluable for response, including 88 (63.3%) who had surgery at 12 weeks and 51 (36.7%) who crossed over due to inadequate clinical response.","['patients with germline BRCA1/2 wild-type/unknown stage I-III TNBC to 12 weeks of', 'triple-negative breast cancer', 'patients with BRCA1/2-proficient tumors', '139 patients were evaluable for response, including 88 (63.3%) who had surgery at 12 weeks and 51 (36.7%) who crossed over due to inadequate clinical response', 'TBCRC 030']","['paclitaxel', 'alternative chemotherapy', 'cisplatin', 'preoperative cisplatin vs. paclitaxel', 'cisplatin or paclitaxel', 'preoperative cisplatin or paclitaxel', 'Cisplatin and paclitaxel', 'paclitaxel or cisplatin chemotherapy']","['HRD score and RCB response', 'HRD results', 'HRD positive', 'RCB-0/1 rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]","[{'cui': 'C0599773', 'cui_str': 'Homologous Recombination'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",139.0,0.03069,"RESULTS


139 patients were evaluable for response, including 88 (63.3%) who had surgery at 12 weeks and 51 (36.7%) who crossed over due to inadequate clinical response.","[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Mayer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: Erica_Mayer@dfci.harvard.edu.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Abramson', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jankowitz', 'Affiliation': 'University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, PA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Falkson', 'Affiliation': 'University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Marcom', 'Affiliation': 'Duke University Cancer Institute, Durham, NC, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Traina', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Carey', 'Affiliation': 'University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rimawi', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Specht', 'Affiliation': 'Seattle Cancer Care Alliance, Seattle, WA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': 'Indiana University Simon Cancer Center, Indianapolis, IN, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Stearns', 'Affiliation': 'Johns Hopkins University Sidney Kimmel Cancer Center, Baltimore, MD, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Tung', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Perou', 'Affiliation': 'University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Richardson', 'Affiliation': 'Johns Hopkins University Sidney Kimmel Cancer Center, Baltimore, MD, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Componeschi', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Trippa', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Tan-Wasielewski', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Timms', 'Affiliation': 'Myriad Genetics Inc., Salt Lake City, UT, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Krop', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Wolff', 'Affiliation': 'Johns Hopkins University Sidney Kimmel Cancer Center, Baltimore, MD, USA.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.08.2064']
2235,32798723,"Addition of Lidocaine to the Distension Medium in Hysteroscopy Decreases Pain During the Procedure - a randomized double blind, placebo controlled trial.","STUDY OBJECTIVE


To evaluate the effect of adding a local anesthetic into the distension medium in office diagnostic hysteroscopy using the vaginoscopic approach on pain during the procedure. Secondary aims included documenting side effects, patient satisfaction and the time needed to complete the procedure.
DESIGN


A randomized double blind placebo controlled study SETTING: A university affiliated hospital; Office hysteroscopy clinic.
PATIENTS


100 patients that underwent office hysteroscopy divided to 50 in the intervention group and 50 in the control group.
INTERVENTIONS


10 ml of lidocaine 2% added into 1000 ml of saline solution that was used as the distension medium for hysteroscopy in the study group vs. 1000 ml of saline alone in the control group.
MEASUREMENTS AND MAIN RESULTS


A significant difference was found in the increment of pain as measured by Visual Analogue Scale (VAS) following the hysteroscopy between the two groups. Patients receiving lidocaine had an average rise of 1.9 in VAS score following the procedure compared with 2.9 in the control group (P=0.033). There was also a non-significant trend for shorter duration of hysteroscopy in the intervention group compared to the control group (180.1 vs. 222.1 seconds, P= 0.08). Patients satisfaction was high in both groups (98% for the study group and 92% for the control group) success rates were also similar between the two groups at around 95%. No side effects were recorded in both groups.
CONCLUSIONS


The addition of local anesthetic into the distension medium in office hysteroscopy produces significant reduction in pain during the procedure without adding time to the procedure and without side effects.",2020,"There was also a non-significant trend for shorter duration of hysteroscopy in the intervention group compared to the control group (180.1 vs. 222.1 seconds, P= 0.08).",['100 patients that underwent office hysteroscopy divided to 50 in the intervention group and 50 in the control group'],"['Lidocaine', 'lidocaine', 'lidocaine 2% added into 1000 ml of saline solution', 'saline alone in the control group', 'placebo']","['increment of pain', 'side effects, patient satisfaction and the time needed to complete the procedure', 'VAS score', 'Pain', 'success rates', 'shorter duration of hysteroscopy', 'pain', 'Visual Analogue Scale (VAS', 'Patients satisfaction', 'side effects']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.213792,"There was also a non-significant trend for shorter duration of hysteroscopy in the intervention group compared to the control group (180.1 vs. 222.1 seconds, P= 0.08).","[{'ForeName': 'Oshri', 'Initials': 'O', 'LastName': 'Barel', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod, Israel; Faculty of health sciences Ben Gurion University of the Negev, Be'er Sheva, Israel. Electronic address: barelod@gmail.com.""}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Preuss', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod, Israel; Faculty of health sciences Ben Gurion University of the Negev, Be'er Sheva, Israel.""}, {'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Stolovitch', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod, Israel; Faculty of health sciences Ben Gurion University of the Negev, Be'er Sheva, Israel.""}, {'ForeName': 'Shiri', 'Initials': 'S', 'LastName': 'Weinberg', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod, Israel; Faculty of health sciences Ben Gurion University of the Negev, Be'er Sheva, Israel.""}, {'ForeName': 'Eran', 'Initials': 'E', 'LastName': 'Barzilay', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod, Israel; Faculty of health sciences Ben Gurion University of the Negev, Be'er Sheva, Israel.""}, {'ForeName': 'Moty', 'Initials': 'M', 'LastName': 'Pansky', 'Affiliation': ""Department of Obstetrics and Gynecology, Samson Assuta Ashdod University Hospital, Ashdod, Israel; Faculty of health sciences Ben Gurion University of the Negev, Be'er Sheva, Israel.""}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.08.003']
2236,32798761,A Randomized Controlled Trial on Irrigation of Open Appendectomy Wound with Gentamicin- Saline Solution versus Saline Solution for Prevention of Surgical Site Infection.,"BACKGROUND


Surgical site infection (SSI) is one of the most common complications after abdominal surgery. The present trial examined the efficacy of saline irrigation of open appendectomy wound with or without topical antibiotics in prevention of SSI.
METHODS


This was a double-blind randomized trial on patients with acute appendicitis who underwent open appendectomy. Patients were randomly allocated to one of three equal groups; group I had layer-by-layer wound irrigation with gentamicin-saline solution, group II had wound irrigation with saline solution, and group III received no irrigation (Control group). The main outcome measures were the incidence of incisional SSI, surgical site occurrence (SSO), other complications, operation time, postoperative pain, and patients' satisfaction.
RESULTS


205 patients (113 female) of a mean age of 27.9 years were included. The average hospital stay and pain scores were similar in the three groups. Groups I and II had significantly lower rates of incisional SSI (4.3% Vs 2.9%; Vs 17.4%, p= 0.005) and SSO (24.6 % Vs 13.4% Vs 43.5%; p= 0.0003) as compared to group III. Groups I and II had comparable rates of SSI and SSO. The three groups had similar rates of wound seroma, hematoma, and dehiscence. Groups I and II had significantly higher satisfaction with the procedure than group III.
CONCLUSIONS


Layer-by-layer irrigation of open appendectomy wound decreased the rates of incisional SSI and SSO significantly compared to the no-irrigation group. Adding gentamicin to saline solution was useless to improve the outcome and did not decrease rates of SSI or other complications.",2020,"Groups I and II had significantly lower rates of incisional SSI (4.3% Vs 2.9%; Vs 17.4%, p= 0.005) and SSO (24.6 %","['patients with acute appendicitis who underwent open appendectomy', '205 patients (113 female) of a mean age of 27.9 years were included']","['gentamicin-saline solution, group II had wound irrigation with saline solution, and group III received no irrigation (Control group', 'Gentamicin- Saline Solution versus Saline Solution', 'saline irrigation of open appendectomy wound with or without topical antibiotics', 'gentamicin to saline solution']","['SSO', 'rates of SSI and SSO', 'rates of incisional SSI', 'rates of wound seroma, hematoma, and dehiscence', 'average hospital stay and pain scores', ""incidence of incisional SSI, surgical site occurrence (SSO), other complications, operation time, postoperative pain, and patients' satisfaction"", 'rates of incisional SSI and SSO']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0017436', 'cui_str': 'Gentamycins'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0332850', 'cui_str': 'Operative site'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0406831', 'cui_str': 'Wound seroma'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",205.0,0.0751698,"Groups I and II had significantly lower rates of incisional SSI (4.3% Vs 2.9%; Vs 17.4%, p= 0.005) and SSO (24.6 %","[{'ForeName': 'Sameh Hany', 'Initials': 'SH', 'LastName': 'Emile', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt. Electronic address: Sameh200@hotmail.com.'}, {'ForeName': 'Ahmed Hossam', 'Initials': 'AH', 'LastName': 'Elfallal', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt. Electronic address: ahmedhos2011@gmail.com.'}, {'ForeName': 'Mohamed Anwar', 'Initials': 'MA', 'LastName': 'Abdel-Razik', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt. Electronic address: drmohamedanwar1981@yahoo.com.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El-Said', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt. Electronic address: mmelsaidshehab@hotmail.com.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Elshobaky', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt. Electronic address: elshobakyayman@yahoo.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.07.057']
2237,32798787,"Twelve weeks of treatment with empagliflozin in patients with heart failure and reduced ejection fraction: A double-blinded, randomized, and placebo-controlled trial.","AIMS


To investigate the effect of the sodium-glucose co-transporter-2 inhibitor empagliflozin on N-terminal pro-b-type natriuretic peptide (NT-proBNP) in patients with heart failure (HF) and reduced ejection fraction (HFrEF).
METHODS AND RESULTS


Empire HF was an investigator-initiated, multi-center, double-blinded, placebo-controlled, randomized trial. Patients with mildly symptomatic HFrEF, mean (standard deviation (SD)) age 64 (11) years, 85% male, and mean left ventricular ejection fraction 29% (8), on recommended HF therapy were assigned to receive either empagliflozin 10 mg once daily or placebo for 12 weeks. The primary endpoint was the between-group difference in the change of NT-proBNP from baseline to 12 weeks. In total, 95 patients were assigned to empagliflozin and 95 to placebo. No significant difference in the change of NT-proBNP with empagliflozin versus placebo was observed [Empagliflozin: baseline, median (interquartile range (IQR)) 582 (304-1020) pg/mL, 12 weeks, 478 (281-961) pg/mL; Placebo: baseline, 605 (322-1070) pg/mL, 12 weeks, 520 (267-1075) pg/mL, adjusted ratio of change empagliflozin/placebo 0.98; 95% confidence interval (CI) 0.82-1.11, P = 0.7]. Further, no significant difference was observed in accelerometer-measured daily activity level [adjusted mean difference of change, empagliflozin versus placebo, -26.0 accelerometer counts; 95% CI -88.0 to 36.0, P = 0.4] or Kansas City Cardiomyopathy Questionnaire Overall Summary Score [adjusted mean difference of change, empagliflozin versus placebo 0.8; 95% CI -2.3 to 3.9, P = 0.6].
CONCLUSION


In low-risk patients with HFrEF with mild symptoms and on recommended HF therapy, empagliflozin did not change NT-proBNP after 12 weeks. Further, no change in daily activity level or health status was observed.",2020,"adjusted ratio of change empagliflozin/placebo 0.98; 95% confidence interval (CI) 0.82-1.11, P = 0.7].","['age 64 (11) years, 85% male, and mean left ventricular ejection fraction 29% (8), on recommended HF therapy', 'patients with heart failure (HF) and reduced ejection fraction (HFrEF', '582', 'Patients with mildly symptomatic HFrEF, mean (standard deviation (SD', 'patients with heart failure and reduced ejection fraction']","['Placebo', 'empagliflozin', 'sodium-glucose co-transporter-2 inhibitor empagliflozin', 'empagliflozin/placebo', 'HF therapy, empagliflozin', 'Empagliflozin', 'empagliflozin 10 mg once daily or placebo', 'placebo']","['daily activity level or health status', 'change of NT-proBNP', 'accelerometer-measured daily activity level', 'median (interquartile range (IQR', 'Kansas City Cardiomyopathy Questionnaire Overall Summary Score']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0022497', 'cui_str': 'Kansas'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",95.0,0.793933,"adjusted ratio of change empagliflozin/placebo 0.98; 95% confidence interval (CI) 0.82-1.11, P = 0.7].","[{'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark. Electronic address: jesper.jensen.06@regionh.dk.'}, {'ForeName': 'Massar', 'Initials': 'M', 'LastName': 'Omar', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark; Faculty of Health Sciences, University of Southern Denmark, J.B. Winsløws Vej 19, 3, 5000 Odense C, Denmark.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Kistorp', 'Affiliation': 'Department of Endocrinology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Mikael Kjær', 'Initials': 'MK', 'LastName': 'Poulsen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Tuxen', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg University Hospital, Bispebjerg Bakke 23, 2400 København NV, Denmark.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Bispebjerg and Frederiksberg University Hospital, Bispebjerg Bakke 23, 2400 København NV, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Gustafsson', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Faber', 'Affiliation': 'Department of Internal Medicine, Center of Endocrinology and Metabolism, Herlev and Gentofte University Hospital, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Emil L', 'Initials': 'EL', 'LastName': 'Fosbøl', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark.'}, {'ForeName': 'Niels Eske', 'Initials': 'NE', 'LastName': 'Bruun', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Sygehusvej 10, 4000 Roskilde, Denmark; Clinical Institute, Aalborg University, Søndre Skovvej 15, 9000 Aalborg, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}, {'ForeName': 'Jan Christian', 'Initials': 'JC', 'LastName': 'Brønd', 'Affiliation': 'RICH/EXE, Department of Sport Science and Clinical Biomechanics, University of Southern Denmark, Campusvej 55, 5230 Odense M, Denmark.'}, {'ForeName': 'Julie Lyng', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'Section of Biostatistics, University of Copenhagen, Øster Farimagsgade 5, 1353 Copenhagen K, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbæk', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark.'}, {'ForeName': 'Jacob Eifer', 'Initials': 'JE', 'LastName': 'Møller', 'Affiliation': 'Department of Cardiology, Odense University Hospital, J. B. Winsløws Vej 4, 5000 Odense C, Denmark; Department of Cardiology, Rigshospitalet, Blegdamsvej 9, 2100 København Ø, Denmark; Faculty of Health Sciences, University of Southern Denmark, J.B. Winsløws Vej 19, 3, 5000 Odense C, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte University Hospital, Borgmester Ib Juuls Vej 1, 2730 Herlev, Denmark; Department of Clinical Medicine, University of Copenhagen, Blegdamsvej 3B, 2200 København N, Denmark.'}]",American heart journal,['10.1016/j.ahj.2020.07.011']
2238,32802290,The Effect of the CO 2  Fractional Laser or Premarin Vaginal Cream on Improving Sexual Function in Menopausal Women: A Randomized Controlled Trial.,"Introduction:  Sexual dysfunction is a complex problem in postmenopausal women with a prevalence rate of 68%-86%. This study aimed to evaluate the effect of a fractional CO 2  laser or vaginal cream on the improvement of sexual function in menopausal women.  Methods:  This is a two-group clinical trial study. Postmenopausal women with the inclusion criterion were enrolled and randomly divided into 2 groups of intervention (n=25) and control group (n=25). In the intervention group, CO 2  laser therapy was performed every month for three months, and in the control group, Premarin vaginal cream was applied (0.625 mg, 3 nights a week for 3 months. Vaginal health index (VHI) scoring and Female Sexual Function Index (FSFI) questionnaires were completed before and three months after the treatment.  Results:  The effects of the laser treatment were greater than the Premarin group with respect to improvement in sexual desire, orgasms, sexual satisfaction, less pain during sexual relations, and overall sexual function ( P  <0.05).  Conclusion:  It seems that the fractional CO 2  laser may be more effective than hormonal therapy in improving sexual function in postmenopausal women.",2020,"The effects of the laser treatment were greater than the Premarin group with respect to improvement in sexual desire, orgasms, sexual satisfaction, less pain during sexual relations, and overall sexual function ( P  <0.05).  ","['postmenopausal women', 'menopausal women', 'postmenopausal women with a prevalence rate of 68%-86', 'Menopausal Women', 'Postmenopausal women with the inclusion criterion']","['CO 2  Fractional Laser or Premarin Vaginal Cream', 'Premarin vaginal cream', 'fractional CO 2  laser or vaginal cream', 'hormonal therapy']","['sexual desire, orgasms, sexual satisfaction, less pain during sexual relations, and overall sexual function', 'FSFI) questionnaires', 'sexual function', 'Vaginal health index (VHI) scoring and Female Sexual Function Index', 'Sexual Function']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0699710', 'cui_str': 'Climarest'}, {'cui': 'C0042238', 'cui_str': 'Vaginal cream'}, {'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C0871356', 'cui_str': 'Sexual Gratification'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}]",,0.0344051,"The effects of the laser treatment were greater than the Premarin group with respect to improvement in sexual desire, orgasms, sexual satisfaction, less pain during sexual relations, and overall sexual function ( P  <0.05).  ","[{'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Eftekhar', 'Affiliation': 'Associate Professor, Vali-Asr Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Forooghifar', 'Affiliation': 'Urogynecology Fellowship, Baharloo Hospital, Department of Pelvic Floor (Urogynecology), Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Khalili', 'Affiliation': 'M.D, Vali-Asr Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mamak', 'Initials': 'M', 'LastName': 'Shariat', 'Affiliation': 'Professor, Maternal, Fetal & Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fedyeh', 'Initials': 'F', 'LastName': 'Haghollahi', 'Affiliation': 'MSC, Vali-Asr Reproductive Health Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of lasers in medical sciences,['10.34172/jlms.2020.49']
2239,32802292,The Effect of Propofol on the Success Rate of Transurethral Lithotripsy by Holmium Laser: A Randomized Clinical Trial.,"Introduction:  Urinary stone disease is the third most common affliction of the urinary tract that has been associated with an increasing incidence. Over decades, great advances have been made in the minimally invasive treatment of urinary stones. Recently, transurethral lithotripsy (TUL) by holmium laser was introduced as a possible therapeutic option. This study evaluated the effect of propofol on the success rate of TUL by holmium laser.  Methods:  A double-blind randomized controlled trial was conducted on 180 patients to investigate the effect of propofol on the success and complication rate of TUL by holmium laser. The enrolled patients were divided into two groups: the first group received sodium thiopental (n=89) while the second group received propofol (n=91). The two groups were compared in terms of the fluctuations of systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), operation time, future stone-free rate (SFR), stone migration, post-operative fever, and ureteral complications such as perforation and mucosal damage. Other developed complications were also recorded. After data gathering, statistical analysis was performed with SPSS version 21.  Results:  the patients' data such as age, sex, stone diameter, stone laterality, duration of stone impaction, primary SBP, DBP and HR were not significantly different between the two groups (P>0.05). TUL and anesthesia duration, first-minute and fifth-minute SBP and DBP, and also changes of HR were significantly lower in the propofol group compared with the sodium thiopental group ( P  <0.001). Moreover, SFR of TUL was more evident in the propofol group. Ureteral mucosal damage was significantly less in the propofol group.  Conclusion:  Propofol was associated with a higher reduction in SBP and DBP, decreased duration of TUL, fewer fluctuations in HR, and an increased success rate of stone removal by TUL with holmium laser.",2020,Ureteral mucosal damage was significantly less in the propofol group.  ,['180 patients'],"['holmium laser', 'transurethral lithotripsy (TUL) by holmium laser', 'Transurethral Lithotripsy by Holmium Laser', 'sodium thiopental', 'Propofol', 'propofol']","['TUL and anesthesia duration, first-minute and fifth-minute SBP and DBP, and also changes of HR', 'Ureteral mucosal damage', 'success rate of stone removal', 'SFR of TUL', 'success and complication rate of TUL', 'success rate of TUL', 'stone diameter, stone laterality, duration of stone impaction, primary SBP, DBP and HR', 'systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), operation time, future stone-free rate (SFR), stone migration, post-operative fever, and ureteral complications such as perforation and mucosal damage', 'SBP and DBP, decreased duration of TUL']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0936073', 'cui_str': 'Thiopental sodium'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1522613', 'cui_str': 'Ureteral route'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1264665', 'cui_str': 'Substance fraction'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0023114', 'cui_str': 'Handedness'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",180.0,0.0223146,Ureteral mucosal damage was significantly less in the propofol group.  ,"[{'ForeName': 'Houman', 'Initials': 'H', 'LastName': 'Teymourian', 'Affiliation': 'Department of Anesthesiology and Critical Care, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Ghiasy', 'Affiliation': 'Department of Urology, Shohada-e-Tajrish Hospital, Shahid Beheshti University Of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tayebi-Azar', 'Affiliation': 'Nephrology and Kidney transplant Research Center, Urmia University of Medical Sciences, Urmia, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Razzaghi', 'Affiliation': 'Department of Urology, Shohada-e-Tajrish Hospital, Shahid Beheshti University Of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ghazal', 'Initials': 'G', 'LastName': 'Sadri', 'Affiliation': 'Resident of Radiology, Department of Radiology, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Ansari Djafari', 'Affiliation': 'Department of Urology, Shohada-e-Tajrish Hospital, Shahid Beheshti University Of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyyed Ali', 'Initials': 'SA', 'LastName': 'Hojjati', 'Affiliation': 'Department of Urology, Shohada-e-Tajrish Hospital, Shahid Beheshti University Of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Poury', 'Affiliation': 'Clinical Research Development Center, Shohadaye Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Shahabi', 'Affiliation': 'Department of Urology, Shohada-e-Tajrish Hospital, Shahid Beheshti University Of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Javanmard', 'Affiliation': 'Department of Urology, Shohada-e-Tajrish Hospital, Shahid Beheshti University Of Medical Sciences, Tehran, Iran.'}]",Journal of lasers in medical sciences,['10.34172/jlms.2020.51']
2240,32802319,Effect of rehabilitation training on an elderly population with mild to moderate hearing loss: study protocol for a randomised clinical trial.,"Background:  Age-related hearing loss (presbycusis) is a form of hearing loss in over 60-year-olds and has a negative impact on quality of life. The pathophysiology of presbycusis is multifactorial and is predominately characterised with a loss of speech perception in noise. In the cochlea, auditory filters decompose broadband sound into a series of narrowband output signals, which contains two kinds of temporal information: slow changes in overall amplitude envelope (ENV) and faster variations in temporal fine structure (TFS). TFS is important for recognition of target speech in noise. The main aim of the study is to evaluate the effect of TFS rehabilitation training in participants over the age of 60 years with mild to moderate hearing loss.  Methods:  A randomised clinical trial will be conducted on 30 participants with mild (loss of 20-39dB) to moderate (40-69dB) hearing loss, aged between 60 and 75 years old. Participants with conductive hearing loss, abnormal middle ear pathology and central nerve system disease will be excluded. Participants will be randomly selected to an intervention and control group with a 1:1 ratio. Rehabilitation for the intervention group will be 30-minute sessions three times a week for a total five weeks of vowel consonant vowel words that are used to eliminate ENV and keep only TFS. Word in noise test, binaural TFS test, and Speech, Spatial and Qualities of Hearing Scale scores will be performed at the beginning and end of study to evaluate the effect of rehabilitation training.  Conclusion:   Life expectancy in the elderly has improved, leading to an increased prevalence of age-related diseases including presbycusis. A literature review highlighted that TFS damage is permanent; however, in this study we will attempt to prove that TFS training may lead to speech in noise perception restored.  Trial registration:  Registry of Clinical Trials, IRCT2019625044006N1 (7  th  August 2019).",2020,"Life expectancy in the elderly has improved, leading to an increased prevalence of age-related diseases including presbycusis.","['participants over the age of 60 years with mild to moderate hearing loss', '30 participants with mild (loss of 20-39dB) to moderate (40-69dB) hearing loss, aged between 60 and 75 years old', 'elderly population with mild to moderate hearing loss', 'Participants with conductive hearing loss, abnormal middle ear pathology and central nerve system disease']","['rehabilitation training', 'TFS training', 'TFS rehabilitation training', 'TFS']","['Word in noise test, binaural TFS test, and Speech, Spatial and Qualities of Hearing Scale scores', 'Life expectancy']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1852284', 'cui_str': 'Mild to moderate hearing loss'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0018777', 'cui_str': 'Conductive hearing loss'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",30.0,0.067655,"Life expectancy in the elderly has improved, leading to an increased prevalence of age-related diseases including presbycusis.","[{'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Rasouli Fard', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 15459-13487, Iran.'}, {'ForeName': 'Farnoush', 'Initials': 'F', 'LastName': 'Jarollahi', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 15459-13487, Iran.'}, {'ForeName': 'Seyyed Jalal', 'Initials': 'SJ', 'LastName': 'Sameni', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 15459-13487, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamali', 'Affiliation': 'Department of Audiology, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, 15459-13487, Iran.'}]",F1000Research,['10.12688/f1000research.23332.1']
2241,32802363,Exploring the effect of problem-based facilitatory teaching approach on metacognition in nursing education: A quasi-experimental study of nurse students in Tanzania.,"Aim


Currently, there has been a progressive shortage of not only the number of frontline healthcare providers but also a decline in the quality of nursing care. There is a growing concern to rethink the approaches on how nurses are prepared, explore and test novel approaches for delivering the nursing curricula. This study tested the effect of the problem-based facilitatory teaching approach on metacognition among nursing students in Tanzania, higher learning institutions.
Design


A controlled pre-/post-test quasi-experimental study design with a quantitative research approach was employed in this study.
Methods


The study was conducted between February-June 2019 including two purposively selected higher learning institutions in the Dodoma region, the central zone of Tanzania. The 401 randomly selected undergraduate nursing students (interventional = 134 and control = 267) were involved. The auditing inventory developed by the researcher measured the intervention, and the questionnaire titled Metacognition Strategies in Nursing was adopted to measure the metacognition, respectively. Statistical analysis was performed using the Statistical Package for the Social Solution (SPSS) software program version 23.
Results


Findings indicated that 65.8% of the study participants were males. The post-test findings revealed a significant gain in metacognition scores among participants in an intervention group between (M = 23.27; SD = 1.716) at baseline and (M = 66.31; SD = 6.204) post-intervention. 63.4% of the total sample in an intervention group demonstrated a high level of knowledge about the regulation of cognition compared to their counterpart control group. However, 69.1% ( N  = 85) participants in the control group performed better for the knowledge about cognition. With the control of other factors, the intervention was found to be more times likely to influence metacognition among nurse students (AOR = 1.603,  p  < 0.05, 95% CI: 1.023, 2.513) . In conclusion, the intervention had the potential to positively effect the levels of metacognition among nurse students. Hence, it was closely linked to professional competency and it would change the spectrum of nursing competency and quality of care among nurse students.",2020,63.4% of the total sample in an intervention group demonstrated a high level of knowledge about the regulation of cognition compared to their counterpart control group.,"['401 randomly selected undergraduate nursing students (interventional\xa0=\xa0134 and control\xa0=\xa0267) were involved', 'nursing students in Tanzania, higher learning institutions', 'February-June 2019 including two purposively selected higher learning institutions in the Dodoma region, the central zone of Tanzania', 'nurse students in Tanzania']",['problem-based facilitatory teaching approach'],"['high level of knowledge about the regulation of cognition', 'knowledge about cognition', 'metacognition scores']","[{'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0458698', 'cui_str': 'Central zone of prostate'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",85.0,0.0221547,63.4% of the total sample in an intervention group demonstrated a high level of knowledge about the regulation of cognition compared to their counterpart control group.,"[{'ForeName': 'Walter C', 'Initials': 'WC', 'LastName': 'Millanzi', 'Affiliation': 'Department of Nursing and Midwifery College of Health Sciences The University of Dodoma Dodoma Tanzania.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Kibusi', 'Affiliation': 'Department of Public Health College of Health Sciences The University of Dodoma Dodoma Tanzania.'}]",Nursing open,['10.1002/nop2.514']
2242,32802823,Effect of hypertonic saline on mucociliary clearance and clinical outcomes in chronic bronchitis.,"Background


Mucus dehydration and impaired mucus clearance are common features of cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD). In CF, inhaled hypertonic saline (HS) improves lung function and produces sustained increases in mucociliary clearance (MCC). We hypothesised that administration of HS (7% NaCl) twice daily for 2 weeks would improve clinical outcomes and produce sustained increases in MCC in COPD subjects with a chronic bronchitis (CB) phenotype.
Methods


Twenty-two CB subjects completed a double-blinded, crossover study comparing inhaled HS to a hypotonic control solution (0.12% saline) administered  via  nebuliser twice daily for 2 weeks. Treatment order was randomised. During each treatment period, symptoms and spirometry were measured. MCC was measured at baseline, shortly after initial study agent administration, and approximately 12 h after the final dose.
Results


HS was safe and well tolerated but overall produced no significant improvements in spirometry or patient-reported outcomes. CB subjects had slower baseline MCC than healthy subjects. The MCC rates over 60 min (Ave60Clr) in CB subjects following 2 weeks of HS were not different from 0.12% saline but were slower than baseline (Ave60Clr was 9.1±6.3% at baseline  versus  5.3±6.9% after HS; p<0.05). Subgroup analyses determined that subjects with residual baseline central lung clearance (14 subjects) had improved spirometry and symptoms following treatment with HS, but not 0.12% saline, treatment.
Conclusions


Inhaled HS appeared to be safe in a general CB population. A specific phenotypic subgroup may benefit from HS but requires additional study.",2020,The MCC rates over 60 min (Ave60Clr) in CB subjects following 2 weeks of HS were not different from 0.12% saline but were slower than baseline (Ave60Clr was 9.1±6.3% at baseline  versus  5.3±6.9% after HS; p<0.05).,"['chronic bronchitis', 'COPD subjects with a chronic bronchitis (CB) phenotype', 'cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD', 'Methods\n\n\nTwenty-two CB subjects']","['HS', 'hypotonic control solution', 'hypertonic saline (HS', 'inhaled HS', 'hypertonic saline']","['mucociliary clearance and clinical outcomes', 'MCC rates', 'clinical outcomes', 'spirometry and symptoms', 'mucociliary clearance (MCC', 'lung function', 'residual baseline central lung clearance', 'MCC', 'safe and well tolerated']","[{'cui': 'C0008677', 'cui_str': 'Chronic bronchitis'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4284772', 'cui_str': '22'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0026687', 'cui_str': 'Mucociliary clearance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",22.0,0.419048,The MCC rates over 60 min (Ave60Clr) in CB subjects following 2 weeks of HS were not different from 0.12% saline but were slower than baseline (Ave60Clr was 9.1±6.3% at baseline  versus  5.3±6.9% after HS; p<0.05).,"[{'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Bennett', 'Affiliation': 'Pulmonary and Critical Care Medicine, Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Ashley G', 'Initials': 'AG', 'LastName': 'Henderson', 'Affiliation': 'Pulmonary and Critical Care Medicine, Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Agathe', 'Initials': 'A', 'LastName': 'Ceppe', 'Affiliation': 'Pulmonary and Critical Care Medicine, Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Kirby L', 'Initials': 'KL', 'LastName': 'Zeman', 'Affiliation': 'Center for Environmental Medicine, Asthma and Lung Biology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Center for Environmental Medicine, Asthma and Lung Biology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Gladman', 'Affiliation': 'Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Fuller', 'Affiliation': 'Pulmonary and Critical Care Medicine, Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Gazda', 'Affiliation': 'Pulmonary and Critical Care Medicine, Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Button', 'Affiliation': 'Pulmonary and Critical Care Medicine, Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Boucher', 'Affiliation': 'Pulmonary and Critical Care Medicine, Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Donaldson', 'Affiliation': 'Pulmonary and Critical Care Medicine, Dept of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",ERJ open research,['10.1183/23120541.00269-2020']
2243,32802868,Influence of Implant Thread Morphology on Primary Stability: A Prospective Clinical Study.,"Objectives


The purpose of this study was to evaluate the primary stability of two implants with the same macro- and micromorphology but different thread design and analyze their clinical outcomes over a one-year period.
Materials and Methods


14 patients needing a partial rehabilitation with a delayed loading approach (DEL group: 9 patients) or a full-arch rehabilitation treated with immediately loaded fixed prostheses supported by 4 implants following the Columbus Bridge Protocol (CBP) (IL group: 5 patients) were included. In each patient, at least one SY (implant with standard threads) and one SL implant (implant with an augmented depth of the threads) were randomly inserted. Primary outcome measures were the number of threads exposed at a torque of 30 Ncm and 50 Ncm and final insertion torque. Secondary outcome measures were implant and prosthetic failure, peri-implant bone resorption, and periodontal parameters: bleeding on probing (BoP), plaque index (PI), and probing depth (PD) evaluated at 3, 6, and 12 months of healing.
Results


Nineteen SY and 19 SL implants were inserted in 14 patients. Twenty implants (10 SL and 10 SY) were inserted in the IL group, while 18 (9 SL and 9 SY) were inserted in the DEL group and followed-up for 12 months. No patients dropped out. No implants and prostheses failed. No biological complications were identified. No significant differences were found between SY and SL implants comparing the number of exposed threads when inserting the implant with a torque insertion of 30 N ( T  student test  p  = .142 and  U  test  p  = .164). At 50 N, no threads were visible in either groups. Final torque insertion values were higher for SL (mean: 48.42 Ncm) compared to SY implants (mean: 43.42 Ncm) without a statistically significant difference. All the implants showed good clinical outcomes at the 1-year-in-function visit.
Conclusions


After 12 months of function, both implant types provided good clinical outcomes without statistically significant differences between the two groups. A difference in insertion torque (even if not statistically significant) was found with higher insertion torque values for SL implants with a larger thread depth.",2020,No significant differences were found between SY and SL implants comparing the number of exposed threads when inserting the implant with a torque insertion of 30 N ( T  student test  p  = .142 and  U  test  ,['14 patients needing a partial rehabilitation with a delayed loading approach (DEL group: 9 patients) or a'],['full-arch rehabilitation treated with immediately loaded fixed prostheses supported by 4 implants following the Columbus Bridge Protocol (CBP'],"['implant and prosthetic failure, peri-implant bone resorption, and periodontal parameters: bleeding on probing (BoP), plaque index (PI), and probing depth (PD) evaluated at 3, 6, and 12 months of healing', 'insertion torque', 'insertion torque values', 'number of threads exposed at a torque of 30\u2009Ncm and 50\u2009Ncm and final insertion torque', 'Final torque insertion values']","[{'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0008628', 'cui_str': 'Chromosomal deletion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0230467', 'cui_str': 'Structure of arch of foot'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0221821', 'cui_str': 'Dental bridge'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4319672', 'cui_str': 'Thread'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}]",14.0,0.0657312,No significant differences were found between SY and SL implants comparing the number of exposed threads when inserting the implant with a torque insertion of 30 N ( T  student test  p  = .142 and  U  test  ,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Menini', 'Affiliation': 'Department of Surgical Sciences (DISC), Implant and Prosthetic Dentistry Unit, University of Genoa, Ospedale S. Martino (pad. 4), L. Rosanna Benzi 10, 16132 Genoa, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bagnasco', 'Affiliation': 'Department of Surgical Sciences (DISC), Implant and Prosthetic Dentistry Unit, University of Genoa, Ospedale S. Martino (pad. 4), L. Rosanna Benzi 10, 16132 Genoa, Italy.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Calimodio', 'Affiliation': 'Department of Surgical Sciences (DISC), Implant and Prosthetic Dentistry Unit, University of Genoa, Ospedale S. Martino (pad. 4), L. Rosanna Benzi 10, 16132 Genoa, Italy.'}, {'ForeName': 'Nicolò', 'Initials': 'N', 'LastName': 'Di Tullio', 'Affiliation': 'Department of Surgical Sciences (DISC), Implant and Prosthetic Dentistry Unit, University of Genoa, Ospedale S. Martino (pad. 4), L. Rosanna Benzi 10, 16132 Genoa, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Delucchi', 'Affiliation': 'Department of Surgical Sciences (DISC), Implant and Prosthetic Dentistry Unit, University of Genoa, Ospedale S. Martino (pad. 4), L. Rosanna Benzi 10, 16132 Genoa, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Baldi', 'Affiliation': 'Department of Surgical Sciences (DISC), Implant and Prosthetic Dentistry Unit, University of Genoa, Ospedale S. Martino (pad. 4), L. Rosanna Benzi 10, 16132 Genoa, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Pera', 'Affiliation': 'Interdepartmental Research Center, Dental-School, University of Turin, Turin, Italy.'}]",BioMed research international,['10.1155/2020/6974050']
2244,32802905,Comparison of student performance by assessment through Objective Structured Practical Examination versus the Conventional Method for second year MBBS students in Microbiology.,"Introduction


Objective Structured Practical Examination (OSPE) is a comprehensive tool for assessment. We wanted to improve our assessment methods and make it a more competence-based evaluation. Thus this study was designed to compare the effectiveness of Objective Structured Practical Examination with that of Conventional Practical Examination.
Methods


This interventional study was carried out in Department of Microbiology atCIMSH, Lucknow over six months from October 2019 till March 2020. One hundredsecond year MBBS students were enrolled. The students were divided into two groups offifty for the conventional examination group (controls) and the OSPE group.On the first day, the cases appeared for OSPE while the controls for conventional examination.On the second day, the groups were crossed over. The students appearing for OSPEwere assessed by their scores at different stations. Feedback forms with a prestructured questionnaire were given to the students and the examiners after OSPE on both days to record their perceptions. Finally, the students' scores were tabulated and comparedstatistically. Microsoft Excel and SPSS were used for data analysis. The data was presented as percentages, mean and standard deviation. Student t test was used and the significance was checked, using p value <0.05.
Results


Overall in OSPE, the students scored higher and the result was statisticallysignificant. The proportion of students in higher marks range was more for OSPE thanthat for the conventional method. The difference was statistically significant (p<0.001).Feedback taken from examiners as well as from the students in the form of astructured questionnaire to analyze their perceptions was very encouraging.
Conclusions


OSPE is a comprehensive assessment modality for practical evaluationof MBBS students. OSPE proved to be an effective tool that improved the students'scores in microbiology.",2020,"The difference was statistically significant (p<0.001).Feedback taken from examiners as well as from the students in the form of astructured questionnaire to analyze their perceptions was very encouraging.
","['second year MBBS students in Microbiology', 'Department of Microbiology atCIMSH, Lucknow over six months from October 2019 till March 2020', 'One hundredsecond year MBBS students were enrolled']","['Introduction\n\n\nObjective Structured Practical Examination (OSPE', 'OSPE', 'conventional examination group (controls) and the OSPE']",[],"[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0025952', 'cui_str': 'Microbiology'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],,0.0202491,"The difference was statistically significant (p<0.001).Feedback taken from examiners as well as from the students in the form of astructured questionnaire to analyze their perceptions was very encouraging.
","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Rajani', 'Affiliation': 'Department of Microbiology, Career Institute of Medical Sciences and Hospital, IIM road, Lucknow, Uttar Pradesh, India.'}, {'ForeName': 'Babaji', 'Initials': 'B', 'LastName': 'Ghewade', 'Affiliation': 'Department of Respiratory Medicine, J N Medical College, Wardha Sciences and Hospital, Wardha, Maharashtra, India.'}]",Journal of advances in medical education & professionalism,['10.30476/jamp.2020.86029.1210']
2245,32802985,Randomized comparison of W.A.R.A. (Wiring Affect with ReAttach) versus distraction: A pilot study assessing the efficacy of an ultrafast transdiagnostic intervention.,"Background


Generally, neuropsychiatric patients share different symptoms across nosological categories, such as, amongst other, psychological distress, mood alterations, anxiety, and self-regulation disturbances.ReAttach is a novel psychological intervention with its key elements being external affect and arousal regulation, stimulation of multiple sensory processing, conceptualization, affective mentalization, and associative memory processing. ReAttach has been hypothesized to be effective in reducing symptom severity in different psychiatric conditions. Given the limited information currently available, the present study aimed to investigate the effect of main ReAttach elements called ""Wiring Affect with ReAttach"" (W.A.R.A.) on negative affect (N.A.), and to compare it with ""Distraction,"" another well-established affect-regulating strategy.
Methods


We used a single-blind, randomized controlled crossover equivalence design to compare the efficacy on N.A. regulation of W.A.R.A. versus Distraction in 101 patients with different neuropsychiatric disorders.
Results


The results showed a significant difference (p < 0.001) in response to W.A.R.A. vs. Distraction, with W.A.R.A. being significantly more effective in regulating N.A., with a large effect size (dRMpooled = 2.38) and a high probability (95%) of success.
Limitations


The heterogeneity of the study population makes generalization and clear recommendations for specific patient groups difficult. The Numeric Rating Scale might have prevented detection of increased N.A. when the baseline scores were high. More in-depth research is needed to explore the W.A.R.A. technique and the extent of confounding variables such as the placebo effect.
Conclusions


The findings suggest that W.A.R.A. may be an effective, accessible, and brief intervention reducing negative affect. Although premature, these first results are encouraging.",2020,"The results showed a significant difference (p < 0.001) in response to W.A.R.A. vs. Distraction, with W.A.R.A. being significantly more effective in regulating N.A., with a large effect size (dRMpooled = 2.38) and a high probability (95%) of success.
",['101 patients with different neuropsychiatric disorders'],"['distraction', 'ultrafast transdiagnostic intervention']",['Numeric Rating Scale'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",101.0,0.0610851,"The results showed a significant difference (p < 0.001) in response to W.A.R.A. vs. Distraction, with W.A.R.A. being significantly more effective in regulating N.A., with a large effect size (dRMpooled = 2.38) and a high probability (95%) of success.
","[{'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Weerkamp-Bartholomeus', 'Affiliation': 'Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Donatella', 'Initials': 'D', 'LastName': 'Marazziti', 'Affiliation': 'Dipartimento di Medicina Clinica e Sperimentale, Section of Psychiatry, University of Pisa, Italy.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Chan', 'Affiliation': 'International Psychology Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Srivastava', 'Affiliation': 'Bharatiya Counselling Psychology Association, New Delhi, India.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'van Amelsvoort', 'Affiliation': 'Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, the Netherlands.'}]",Heliyon,['10.1016/j.heliyon.2020.e04660']
2246,32803113,Does the repeat dose of gonadotropin-releasing hormone agonist trigger in polycystic ovarian syndrome improve in vitro fertilization cycles outcome? A clinical trial study.,"Background


A repeat dose of Gonadotropin-releasing Hormone (GnRH) agonist could provide long duration of luteinizing hormone (LH) surge and amplitude appropriately.
Objective


Improvement in oocyte maturity could be obtained by a repeat dose of GnRH agonist.
Materials and Methods


In this randomized double-blinded study, 120 women with polycystic ovarian syndrome and serum estradiol level (E2)  >  3000 who were candidate for in vitro fertilization with Antagonist protocol were enrolled between July 2018 and July 2019. Participants were randomized in two groups - and final oocyte maturation was triggered with two doses: In group A, a repeat dose of 0.1 mg, 12 hr. after the first dose and in group B, 0.2 mg SC triptorelin (decapeptyl) 35 hr. prior to oocyte retrieval. Serum Estradiol, LH, and progesterone concentration were measured on the trigger day. Serum LH measurement was done three times in both groups. The outcomes were oocyte yield, meiosis (M) I, MII, Maturity rate, germinal vesicle (GV) rate, 2 pronuclear, embryo yield, ovarian hyper stimulation syndrome rates.
Results


Maturity rate (p = 0.89), MI (p = 0.38), MII (p = 0.89), and GV oocytes (p = 0.38) were not statistically different between the two study groups. LH levels measured at 12 hr post-trigger did not relate statistically significant with maturity rate in our participants (p = 0.96). No empty follicular syndrome was reported.
Conclusion


Although, the second dose of GnRH agonist after 12 hr since the first dose could provide duration of LH surge and amplitude and as a result no empty follicular syndrome was seen, the maturity rate, MI, MII, and GV oocytes were not different between the two study groups.",2020,"Results


Maturity rate (p = 0.89), MI (p = 0.38), MII (p = 0.89), and GV oocytes (p = 0.38) were not statistically different between the two study groups.",['120 women with polycystic ovarian syndrome and serum estradiol level (E2)  >  3000 who were candidate for in vitro fertilization with Antagonist protocol were enrolled between July 2018 and July 2019'],"['SC triptorelin', 'gonadotropin-releasing hormone agonist trigger', 'Gonadotropin-releasing Hormone (GnRH) agonist']","['oocyte yield, meiosis (M) I, MII, Maturity rate, germinal vesicle (GV) rate, 2 pronuclear, embryo yield, ovarian hyper stimulation syndrome rates', 'MI', 'luteinizing hormone (LH) surge', 'MII', 'maturity rate', 'Serum Estradiol, LH, and progesterone concentration', 'Maturity rate', 'GV oocytes', 'maturity rate, MI, MII, and GV oocytes', 'LH levels', 'Serum LH measurement']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0077275', 'cui_str': 'Triptorelin'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0025186', 'cui_str': 'Meiosis'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C0333262', 'cui_str': 'Vesicle'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1287355', 'cui_str': 'Hormone level - finding'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441683', 'cui_str': 'Hormone measurement'}]",120.0,0.307118,"Results


Maturity rate (p = 0.89), MI (p = 0.38), MII (p = 0.89), and GV oocytes (p = 0.38) were not statistically different between the two study groups.","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Aflatoonian', 'Affiliation': 'Department of Obstetrics and Gynecology, Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Science, Yazd, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Haghighi', 'Affiliation': 'Department of Obstetrics and Gynecology, Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Science, Yazd, Iran.'}, {'ForeName': 'Masrooreh', 'Initials': 'M', 'LastName': 'Hoseini', 'Affiliation': 'Department of Obstetrics and Gynecology, Research and Clinical Center for Infertility, Yazd Reproductive Sciences Institute, Shahid Sadoughi University of Medical Science, Yazd, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Haghdani', 'Affiliation': 'Department of Urology, Hasheminejad Kidney Research Center (HKRC), Iran University of Medical Science, Tehran, Iran.'}]","International journal of reproductive biomedicine (Yazd, Iran)",['10.18502/ijrm.v13i7.7363']
2247,32803127,"Application of behavioral economics principles to reduce injectable contraceptive discontinuation in rural Ethiopia: A stratified-pair, cluster-randomized field trial.","Background:  Contraceptive prevalence in Ethiopia jumped from 6% in 2000 to 36% in 2016, mainly due to increased injectable method use. However, discontinuation rates among injectable users were high (38%). Given that the public sector is the major source for injectable contraceptives, John Snow Inc. (JSI) in collaboration with ideas42 worked with Ethiopia's flagship Health Extension Program to apply behavioral design to mitigate discontinuation of injectable contraceptives.  Methods:  We applied behavioral economics insights to mitigate the discontinuation of injectable contraceptives. This process created an intervention package, consisting of a health worker planning calendar, a client counseling job aid, and client appointment cards. A stratified-pair cluster-randomized field trial tested the effectiveness of the intervention. The study area included two districts from the four regions where JSI was implementing a family planning program. One district from each region was randomly allocated to the intervention arm. Women visiting health posts to use injectable contraceptives were enrolled in the study. Regression methods, adjusted for study design, participants' backgrounds, and contextual factors, estimated the intervention's effect on discontinuation rates.  Results:  A behavioral design methodology was feasibly implemented in a rural, low-resource setting in Ethiopia. The resultant intervention package was successfully delivered in 19 satellite health posts in four districts. Intervention adherence was high for the appointment cards and counseling job aid, but not for the planning calendar. The injectable discontinuation rate was 10.8 % (95% confidence interval: 2.2, 19.3) points lower in the intervention area compared to the control area during the post-intervention follow-up survey.  Conclusion:  The use of two tools informed by behavioral economics -the appointment card and counseling job aid-effectively decreased injectable discontinuation even with the presence of other health system bottlenecks. Behavioral economics insights and the behavioral design methodology have the potential to enhance family planning programs in Ethiopia and elsewhere.",2019,The injectable discontinuation rate was 10.8 % points lower in the intervention area compared to the control area during the post intervention follow-up survey.  ,"['Women visiting health posts to use injectable contraceptives were enrolled in the study', 'rural Ethiopia', 'primary drivers of discontinuation of injectable contraceptives']",[],"['Contraceptive prevalence', 'discontinuation rates', 'Intervention adherence', 'injectable discontinuation rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",[],"[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}]",,0.033453,The injectable discontinuation rate was 10.8 % points lower in the intervention area compared to the control area during the post intervention follow-up survey.  ,"[{'ForeName': 'Ali Mehryar', 'Initials': 'AM', 'LastName': 'Karim', 'Affiliation': 'Global Development, Bill & Melinda Gates Foundation, Addis Ababa, Ethiopia.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Guichon', 'Affiliation': 'ideas42, New York, New York, 10004, USA.'}, {'ForeName': 'Bantalem Yeshanew', 'Initials': 'BY', 'LastName': 'Yihun', 'Affiliation': 'The Last Ten Kilometers Project 2020, JSI Research & Training Institute, Inc., Addis Ababa, Ethiopia.'}, {'ForeName': 'Nebreed Fesseha', 'Initials': 'NF', 'LastName': 'Zemichael', 'Affiliation': 'The Last Ten Kilometers Project 2020, JSI Research & Training Institute, Inc., Addis Ababa, Ethiopia.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Lorenzana', 'Affiliation': 'ideas42, Washington, DC, 20005, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Barofsky', 'Affiliation': 'ideas42, New York, New York, 10004, USA.'}, {'ForeName': 'Wuleta', 'Initials': 'W', 'LastName': 'Betemariam', 'Affiliation': 'The Last Ten Kilometers Project 2020, JSI Research & Training Institute, Inc., Addis Ababa, Ethiopia.'}]",Gates open research,['10.12688/gatesopenres.12987.2']
2248,32799029,Objective sleep disturbance is associated with poor response to cognitive and behavioral treatments for insomnia in postmenopausal women.,"STUDY OBJECTIVES


To determine whether insomnia patients with objective sleep disturbance are less responsive to cognitive and behavioral treatments than those without objective sleep disturbance, characterize effects of insomnia therapy on objective sleep, and determine whether reductions in nocturnal cognitive arousal correspond to changes in objective sleep.
METHODS


Secondary analysis of a single-site, randomized controlled trial. 113 postmenopausal women (56.40 ± 5.34 years) with menopause-related insomnia disorder were randomized to three treatment conditions: cognitive-behavioral therapy for insomnia (CBTI), sleep restriction therapy (SRT), or sleep education control. Primary outcomes were the Insomnia Severity Index (ISI) and polysomnography (PSG) sleep parameters and were collected at pretreatment, posttreatment, and six-month follow-up.
RESULTS


Patients with lower pretreatment PSG sleep efficiency had lower rates of insomnia remission after active treatment relative to those with higher sleep efficiency (37.8% vs 61.8%). Neither CBTI and SRT produced clinically meaningful effects on PSG sleep. Exploratory analyses revealed that reductions in nocturnal cognitive arousal were associated with decreases in PSG sleep latency, but not wake after sleep onset.
CONCLUSIONS


Our findings support an emerging literature suggesting that insomnia patients with objective sleep disturbance may have blunted response to insomnia therapy. Research is needed to enhance treatments to better improve insomnia in patients with objective sleep disturbance. A lack of observed CBTI and SRT effects on PSG sleep suggests that these therapies may be presently ill-designed to improve objective sleep. Nocturnal cognitive arousal may represent an entry point to improve objective sleep latency in insomnia. NAME: Behavioral Treatment of Menopausal Insomnia: Sleep and Daytime Outcomes. URL: clinicaltrials.gov. Registration: NCT01933295.",2020,"Exploratory analyses revealed that reductions in nocturnal cognitive arousal were associated with decreases in PSG sleep latency, but not wake after sleep onset.
","['insomnia patients with objective sleep disturbance', 'postmenopausal women', 'patients with objective sleep disturbance', '113 postmenopausal women (56.40\xa0±\xa05.34 years) with menopause-related insomnia disorder']","['NAME', 'CBTI and SRT', 'cognitive-behavioral therapy for insomnia (CBTI), sleep restriction therapy (SRT), or sleep education control']","['Insomnia Severity Index (ISI) and polysomnography (PSG) sleep parameters', 'PSG sleep', 'nocturnal cognitive arousal', 'Nocturnal cognitive arousal', 'PSG sleep latency', 'sleep efficiency', 'insomnia remission']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C2584987', 'cui_str': 'Sleep restriction therapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",113.0,0.0431924,"Exploratory analyses revealed that reductions in nocturnal cognitive arousal were associated with decreases in PSG sleep latency, but not wake after sleep onset.
","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Chaewon', 'Initials': 'C', 'LastName': 'Sagong', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, 48202, USA. Electronic address: cdrake1@hfhs.org.'}]",Sleep medicine,['10.1016/j.sleep.2020.04.024']
2249,32799042,Continuous positive airway pressure effectively ameliorates arrhythmias in patients with obstructive sleep apnea-hypopnea via counteracting the inflammation.,"INTRODUCTION


This work is aimed at evaluating the therapeutic effect of continuous positive airway pressure (CPAP) in treatment of patients with obstructive sleep apnea-hypopnea syndrome (OSAHS) combined with arrhythmias as well as clarifying the possible mechanism underpinning such an intervention.
METHODS


Through exclusions, a total of 108 OSAHS patients combined with arrhythmias were enrolled from June 2017 to June 2019 with full clinical information in this work. A computerized permuted block design with varying block stratification and size according to age, sex, AHI and type of arrhythmia was used to randomize 108 patients to CPAP versus sham CPAP for a period of 12-week. All were subjected to unchanged pharmacological anti-arrhythmia therapy combined with CPAP. Before and after CPAP treatment, the improvement of various arrhythmias was compared between the CPAP group and the sham-CPAP group. The levels of CRP, IL-6 and TNF-ɑ were measured simultaneously.
RESULTS


During follow-up, the mean (±SD) CPAP pressure used in the CPAP group was 12.3 (±3.1) cm H2O. The use of CPAP and sham CPAP was on average of 5.2 ± 0.56 and 5.1 ± 0.63 h/night, respectively. After 12 weeks of CPAP therapy, the AHI was significantly decreased and the lowest blood oxygen saturation was notably elevated in the CPAP group compared to the sham-CPAP group, P < 0.05. The CPAP therapy, compared with the sham-CPAP group, significantly reduced the incidence of all types of arrhythmia in patients with OSAHS. The level of the c-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α) was significantly lower in the CPAP group than in the sham-CPAP group (P < 0.05). Pearson correlation analysis showed that the reduction in the incidence of total arrhythmias was positively correlated with the decrease of CRP, IL-6 and TNF-ɑ levels, respectively.
CONCLUSION


Findings from this work suggest that proper use of CPAP significantly benefits to OSAHS patients combined with arrhythmias, possibly via counteracting the inflammation.",2020,"The CPAP therapy, compared with the sham-CPAP group, significantly reduced the incidence of all types of arrhythmia in patients with OSAHS.","['patients with obstructive sleep apnea-hypopnea via counteracting the inflammation', '108 OSAHS patients combined with arrhythmias were enrolled from June 2017 to June 2019 with full clinical information in this work', 'patients with obstructive sleep apnea-hypopnea syndrome (OSAHS', 'patients with OSAHS']","['CPAP versus sham CPAP', 'CPAP', 'continuous positive airway pressure (CPAP', 'pharmacological anti-arrhythmia therapy combined with CPAP', 'Continuous positive airway pressure', 'CPAP and sham CPAP']","['mean (±SD) CPAP pressure', 'incidence of total arrhythmias', 'lowest blood oxygen saturation', 'improvement of various arrhythmias', 'CRP, IL-6 and TNF-ɑ levels', 'level of the c-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-α (TNF-α', 'incidence of all types of arrhythmia', 'levels of CRP, IL-6 and TNF-ɑ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C4285910', 'cui_str': 'Obstructive sleep apnea hypopnea syndrome'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",108.0,0.024615,"The CPAP therapy, compared with the sham-CPAP group, significantly reduced the incidence of all types of arrhythmia in patients with OSAHS.","[{'ForeName': 'Xiaoting', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Yue', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Zhenhua', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Yongjun', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Sleep Medicine Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Fumin', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Sleep Medicine Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Minglu', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Sleep Medicine Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, PR China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, 250021, PR China. Electronic address: zg000507@163.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102655']
2250,32799056,Comparing the impact of educational messages based on an extended parallel process model on solid waste separation behaviors in female students: A four-group randomized trial.,"BACKGROUND


The increase in non-separated solid waste is a threat to environmental health. People may be motivated to reduce the destructive effects of waste accumulation in the environment by receiving educational messages and learning the proper methods of waste separation. This study aimed to determine the effect of educational messages on waste separation in dormitory students based on Extended Parallel Process Model (EPPM).
METHODS


This randomized controlled trial was performed on 320 students categorized into four groups from October to December 2019. After installing waste separation tags on separate containers, three types of messages were presented to encourage and educate waste separation in the following four groups: threat messages; efficacy messages; threat/efficacy messages; and control group. Data were collected prior to and one week after training by a self-reported valid and reliable questionnaire. They were analyzed in SPSS21.
RESULTS


In the efficacy group and threat/efficacy group, not only the mean scores of ""perceived threat associated with non-segregation and waste accumulation"", ""attitude"" and ""intention"" but also the mean score of ""efficacy"" and ""waste separation behavior"" were improved (P < 0.05). In both groups, the mean score of ""perceived barriers"" for waste separation was lower than the other two groups (P < 0.001).
DISCUSSION


Use of efficacy-based massages alone or in combination with the threat component was proposed to promote waste separation. No specific study has documented the effectiveness of messages based on EPPM on solid waste separation behaviors. The current study highlighted the effectiveness of using EPPM to promote waste-separation behavior in practice, not in theory.",2020,"In both groups, the mean score of ""perceived barriers"" for waste separation was lower than the other two groups (P < 0.001).
","['female students', '320 students categorized into four groups from October to December 2019', 'dormitory students based on Extended Parallel Process Model (EPPM']","['educational messages', 'EPPM']","['mean score of ""perceived barriers"" for waste separation', 'mean score of ""efficacy"" and ""waste separation behavior', 'mean scores of ""perceived threat associated with non-segregation and waste accumulation"", ""attitude"" and ""intention']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0080141', 'cui_str': 'Racial Segregation'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",320.0,0.0326594,"In both groups, the mean score of ""perceived barriers"" for waste separation was lower than the other two groups (P < 0.001).
","[{'ForeName': 'Aazam', 'Initials': 'A', 'LastName': 'Abbasi', 'Affiliation': 'Student Research Committee, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Araban', 'Affiliation': 'Health Education and Promotion Department, Public Health School, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Heidari', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Alidosti', 'Affiliation': 'Department of Public Health, Behbahan Faculty of Medical Sciences, Behbahan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Zamani-Alavijeh', 'Affiliation': 'Department of Health Education and Promotion, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: fe.zamani@hlth.mui.ac.ir.'}]","Waste management (New York, N.Y.)",['10.1016/j.wasman.2020.07.041']
2251,32799180,The effect of small versus large clog size on emergency response time: A randomized controlled trial.,"OBJECTIVES


To assess the effect on healthcare professional emergency response time and safety of small compared to large clog size.
DESIGN


Randomized controlled trial.
SETTING


The intensive care unit of a single university medical centre in The Netherlands.
PARTICIPANTS


Intensive care medicine professionals.
INTERVENTIONS


Participants were randomized to wear European size 38 clogs (US male size 6½, US female size 7½) or European size 47 clogs (US male size 13½, US female size 14½) clogs and were required to run a 125 m course from the coffee break room to the elevator providing access to the emergency department.
MAIN OUTCOME MEASURES


The primary outcome was the time to complete the running course. Height, shoe size, self-described fitness, age and staff category were investigated as possible effect modifiers. Secondary endpoints were reported clog comfort and suspected unexpected clog-related adverse events (SUCRAEs).
RESULTS


50 participants were randomized (25 to European size 38 clogs and 25 to size 47 clogs). Mean age was 37 years (SD 12) and 29 participants (58%) were female. The primary outcome was 4.4 s (95% CI -7.1; -1.6) faster in the size 5 clogs group compared to the size 12 clogs group. This effect was not modified by any of the predefined participant characteristics. No differences were found in reported clog comfort or SUCRAEs.
CONCLUSIONS


European size 38 clogs lead to faster emergency response times than size 47 clogs.
TRIAL REGISTRATION


NCT04406220.",2020,"No differences were found in reported clog comfort or SUCRAEs.
","['Intensive care medicine professionals', 'The intensive care unit of a single university medical centre in The Netherlands', 'Participants were randomized to wear European size 38 clogs (US male size 6½, US female size 7½) or European size 47 clogs (US male size 13½, US female size 14½) clogs and were required to run a 125\xa0m course from the coffee break room to the elevator providing access to the emergency department', 'Mean age was 37\xa0years (SD 12) and 29 participants (58%) were female', '50 participants']",[],"['clog comfort and suspected unexpected clog-related adverse events (SUCRAEs', 'time to complete the running course', 'emergency response time', 'Height, shoe size, self-described fitness, age and staff category']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0013890', 'cui_str': 'Elevator'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0426931', 'cui_str': 'Shoe size'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}]",50.0,0.195819,"No differences were found in reported clog comfort or SUCRAEs.
","[{'ForeName': 'Paul W G', 'Initials': 'PWG', 'LastName': 'Elbers', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Amsterdam Cardiovascular Sciences (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands. Electronic address: p.elbers@amsterdamumc.nl.'}, {'ForeName': 'Harm-Jan', 'Initials': 'HJ', 'LastName': 'de Grooth', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Amsterdam Cardiovascular Sciences (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Armand R J', 'Initials': 'ARJ', 'LastName': 'Girbes', 'Affiliation': 'Department of Intensive Care Medicine, Amsterdam Medical Data Science (AMDS), Amsterdam Cardiovascular Sciences (ACS), Amsterdam Infection and Immunity Institute (AI&II), Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands.'}]",Journal of critical care,['10.1016/j.jcrc.2020.07.028']
2252,32799365,Randomized clinical trial comparing peg-based synthetic to porcine-derived collagen membrane in the preservation of alveolar bone following tooth extraction in anterior maxilla.,"OBJECTIVES


The objective of this randomized controlled trial was to compare alveolar ridge preservation using a bone substitute material and covered with a synthetic or porcine collagen membrane.
MATERIALS AND METHODS


Thirty-two sockets in the esthetic maxillary region of 30 patients were randomised into two groups. Randomisation was stratified according to bone wall defect. Flapless technique was used and sockets were grafted with bi-phasic calcium phosphate particulate bone substitute and covered by synthetic poly-ethylene glycol (PEG; test group) or porcine derived collagen membrane (CM; control group). No primary closure was attempted. A cone beam computed tomography (CBCT) scan was performed immediately after the surgical procedure and repeated 22 weeks later. OnDemand3D was used to superimpose scan images and assess changes. The mean vertical and horizontal percentage bone loss were calculated and implants placed after 6 months with or without additional augmentation.
RESULTS


There were no baseline differences between groups or dropouts. The mean percentage loss at the labial plate and at the coronal part of the sockets was statistically significantly lower in the test group compared to controls [-2.86% (SD=13.48) vs 7.42% (SD=11.95); 13.45% (SD = 11.97) vs 28.59% (SD = 16.97)]. Implants were placed after 6 months and there was no difference in need for further augmentation between PEG(n=5) or CM(n=4).
CONCLUSION


Sites treated with PEG membrane showed less percentage loss in horizontal and vertical measurements in this trial.",2020,"Implants were placed after 6 months and there was no difference in need for further augmentation between PEG(n=5) or CM(n=4).
","['anterior maxilla', 'Thirty-two sockets in the esthetic maxillary region of 30 patients']","['cone beam computed tomography (CBCT) scan', 'peg-based synthetic to porcine-derived collagen membrane', 'bone substitute material and covered with a synthetic or porcine collagen membrane', 'Flapless technique was used and sockets were grafted with bi-phasic calcium phosphate particulate bone substitute and covered by synthetic poly-ethylene glycol (PEG; test group) or porcine derived collagen membrane (CM; control group', 'PEG membrane']","['mean percentage loss', 'mean vertical and horizontal percentage bone loss']","[{'cui': 'C0459697', 'cui_str': 'Anterior segment of maxilla'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0243003', 'cui_str': 'Bone Substitute'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C3486131', 'cui_str': 'Pork collagen preparation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0006711', 'cui_str': 'calcium phosphate'}, {'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C0015083', 'cui_str': 'ethylene glycol'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",30.0,0.0841553,"Implants were placed after 6 months and there was no difference in need for further augmentation between PEG(n=5) or CM(n=4).
","[{'ForeName': 'Shakeel', 'Initials': 'S', 'LastName': 'Shahdad', 'Affiliation': 'Barts Health NHS Trust, The Royal London Dental Hospital. Honorary Clinical Professor in Oral Rehabilitation and Implantology, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Gamble', 'Affiliation': 'Barts Health NHS Trust, The Royal London Dental Hospital, UK.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Matani', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Gambôa', 'Affiliation': 'University of Bristol, School of Oral and Dental Sciences, Periodontology, Bristol, UK.'}]",Clinical oral implants research,['10.1111/clr.13648']
2253,32799397,Enhancing Patient Understanding of Medication Risks and Benefits.,"OBJECTIVE


To evaluate the effectiveness of: the DrugFactsBox ®  format for presenting written medication information and the SMART (Strategic Memory Advanced Reasoning Training) Program designed to enhance gist reasoning ability.
METHODS


We used a 2 x 2 factorial research design. 286 patients with rheumatoid arthritis were randomly assigned to one of four groups: DrugFactsBox ®  Only, DrugFactsBox ®  Plus SMART, Other Consumer Medication Information (CMI) Only, and Other CMI Plus SMART. Data were collected via telephone interviews and online questionnaires at four time points: Baseline and 6-weeks, 3-months, and 6-months following baseline. The primary outcome variable was Informed Decision-Making, defined as making a value-consistent decision concerning use of disease modifying antirheumatic drugs based on adequate knowledge.
RESULTS


We found no main effects for the two interventions, either alone or in combination. However, there was a significant interaction between assignment to SMART/No SMART Program and Informed Decision-Making at baseline. Among participants in the SMART groups who did not meet the criteria for Informed Decision-Making at baseline, 42.5% met the criteria at the 6-month follow-up, compared to 23.6% of participants in the No SMART groups (Mean Difference=18.9, 95% CI=5.6, 32.2, p=0.007). This difference was driven by increased knowledge in the SMART groups. Among participants who met the criteria for Informed Decision-Making at baseline, the difference between the SMART and No SMART groups was not statistically significant.
CONCLUSIONS


Participation in a theory-driven program to enhance gist reasoning may have a beneficial effect on Informed Decision-Making among patients with inadequate knowledge concerning therapeutic options.",2020,"Among participants who met the criteria for Informed Decision-Making at baseline, the difference between the SMART and No SMART groups was not statistically significant.
",['286 patients with rheumatoid arthritis'],"['DrugFactsBox ®  Only, DrugFactsBox ®  Plus SMART, Other Consumer Medication Information (CMI) Only, and Other CMI Plus SMART']","['Informed Decision-Making, defined as making a value-consistent decision concerning use of disease modifying antirheumatic drugs based on adequate knowledge']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1998726', 'cui_str': 'Is informed'}]",286.0,0.035954,"Among participants who met the criteria for Informed Decision-Making at baseline, the difference between the SMART and No SMART groups was not statistically significant.
","[{'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Blalock', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Solow', 'Affiliation': 'Division of Rheumatic Diseases, University of Texas Southwestern, Dallas, Texas, USA.'}, {'ForeName': 'Valerie F', 'Initials': 'VF', 'LastName': 'Reyna', 'Affiliation': 'Center for Behavioral Economics and Decision Research, Human Neuroscience Institute, Cornell University, Ithaca, New York, USA.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Keebler', 'Affiliation': 'Center for BrainHealth, University of Texas at Dallas, Dallas, Texas, USA.'}, {'ForeName': 'Delesha', 'Initials': 'D', 'LastName': 'Carpenter', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Caprice', 'Initials': 'C', 'LastName': 'Hunt', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Hickey', 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Kimberlee', 'Initials': 'K', 'LastName': ""O'Neill"", 'Affiliation': 'Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Curtis', 'Affiliation': 'Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Sandra Bond', 'Initials': 'SB', 'LastName': 'Chapman', 'Affiliation': 'Center for BrainHealth, University of Texas at Dallas, Dallas, Texas, USA.'}]",Arthritis care & research,['10.1002/acr.24421']
2254,32799565,Pharmacokinetics and bioequivalence of a generic empagliflozin tablet  versus  a brand-named product and the food effects in healthy Chinese subjects.,"Objective : The aim of the present study was to assess the bioequivalence of a generic empagliflozin tablet  versus  a brand-named empagliflozin tablet (Jardiance®) and evaluate the food effects on the pharmacokinetics of empagliflozin in healthy Chinese subjects. Methods:  Forty-eight healthy volunteers were included in this randomized, open-label, crossover, two-period study (fasting: n = 24, fed: n = 24). A single dose of 25-mg generic (or test) or brand-named (or reference) empagliflozin was administered to each subject in a randomized sequence. Blood samples were collected at the baseline and during the 72 hours post-dose, and plasma empagliflozin concentrations were determined by high performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS). Pharmacokinetic parameters were analyzed with non-compartmental methods. Safety were monitored. Results:  The major pharmacokinetic parameters including C max , AUC 0-t  and AUC 0-∞  were similar between the generic and brand-named tablets under fasting and fed conditions (all  p  > 0.05). The 90% confidence intervals of the test/reference ratios of log-transformed C max , AUC 0-t  and AUC 0-∞  were 94.90%-106.70%, 100.62%-106.99% and 100.64%-106.85%, respectively, under fasting condition, and 94.21-104.91%, 97.31-101.79% and 97.32-101.83%, respectively, under fed condition. High-fat food did not affect C max , AUC 0-t , AUC 0-∞  or t max  of empagliflozin (all  p  > 0.05). There was no serious adverse event during the study period. Conclusion:  The generic formulation of empagliflozin tablet is bioequivalent to the brand-named product in healthy Chinese volunteers, and well tolerated. High-fat food had no effects on the pharmacokinetics of empagliflozin in healthy Chinese volunteers.",2020,"High-fat food did not affect C max , AUC 0-t ,","['Methods:  Forty-eight healthy volunteers', 'healthy Chinese subjects', 'healthy Chinese volunteers']","['empagliflozin', 'generic empagliflozin', 'generic empagliflozin tablet  versus  a brand-named empagliflozin tablet (Jardiance®', '25-mg generic (or test) or brand-named (or reference) empagliflozin', 'empagliflozin ']","['tolerated', 'Blood samples', 'C max , AUC 0-t ', 'plasma empagliflozin concentrations', 'reference ratios of log-transformed C max , AUC 0-t  and AUC 0-∞', 'C max , AUC 0-t  and AUC 0-∞']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C3848959', 'cui_str': 'empagliflozin Oral Tablet'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C3848669', 'cui_str': 'Jardiance'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",48.0,0.0296417,"High-fat food did not affect C max , AUC 0-t ,","[{'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, Hunan 410015, The People's Republic of China.""}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, Hunan 410015, The People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, Hunan 410015, The People's Republic of China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, Hunan 410015, The People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, Hunan 410015, The People's Republic of China.""}, {'ForeName': 'Yangyang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, Hunan 410015, The People's Republic of China.""}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Department of Pharmacy, The Third Hospital of Changsha, Changsha, Hunan 410015, The People's Republic of China.""}]",Drug development and industrial pharmacy,['10.1080/03639045.2020.1810263']
2255,32799649,A Collaborative and Cognitive-based Intervention for Young People with Cerebral Palsy.,"BACKGROUND.


Evidence-based approaches to improve function in individuals with cerebral palsy are needed.
PURPOSE.


To investigate the effectiveness of the Cognitive Orientation to daily Occupational Performance approach™ (CO-OP) to improve performance on self-chosen, functional goals as compared to traditional occupational therapy for cerebral palsy.
METHOD.


Crossover design with 12 participants, aged 6-15 years, randomly assigned to CO-OP and traditional intervention groups, followed by crossover and a 3-month follow-up. The participants identified three occupation-based goals for CO-OP and each group received ten 45-minutes intervention twice weekly in clinical context. Occupational performance, manual dexterity and Gross Motor Function Measures were analysed using generalized estimating equations.
FINDINGS.


There were clinical and statistically significant improvements in functional goals following CO-OP and not traditional therapy. There were gains in dexterity but not in gross motor skills.
IMPLICATIONS.


CO-OP was effective to improve functional performance in young people with cerebral palsy and should be more utilized.",2020,"To investigate the effectiveness of the Cognitive Orientation to daily Occupational Performance approach™ (CO-OP) to improve performance on self-chosen, functional goals as compared to traditional occupational therapy for cerebral palsy.
","['12 participants, aged 6-15 years', 'Young People with Cerebral Palsy', 'individuals with cerebral palsy', 'young people with cerebral palsy']","['CO-OP and traditional intervention', 'Collaborative and Cognitive-based Intervention', 'CO-OP', 'Cognitive Orientation to daily Occupational Performance approach™ (CO-OP']","['functional performance', 'Occupational performance, manual dexterity and Gross Motor Function Measures', 'functional goals', 'gains in dexterity']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.0186376,"To investigate the effectiveness of the Cognitive Orientation to daily Occupational Performance approach™ (CO-OP) to improve performance on self-chosen, functional goals as compared to traditional occupational therapy for cerebral palsy.
","[{'ForeName': 'Larissa K', 'Initials': 'LK', 'LastName': 'Sousa', 'Affiliation': ''}, {'ForeName': 'Marina Brito', 'Initials': 'MB', 'LastName': 'Brandão', 'Affiliation': ''}, {'ForeName': 'Clare M', 'Initials': 'CM', 'LastName': 'Curtin', 'Affiliation': ''}, {'ForeName': 'Livia C', 'Initials': 'LC', 'LastName': 'Magalhães', 'Affiliation': ''}]",Canadian journal of occupational therapy. Revue canadienne d'ergotherapie,['10.1177/0008417420946608']
2256,32799753,The immediate effect of the abdominal drawing-in maneuver technique on stature change in seated sedentary workers with chronic low back pain.,"Many studies have measured stature change arising from loads imposed on the spine during sitting. To improve stature recovery, it is important to stabilize the lumbar spine and compensate forces from the upper body. The abdominal drawing-in maneuver (ADIM) technique has been found to mainly activate deep trunk muscles. The purpose of this study was to determine whether activation of deep trunk muscles by the ADIM technique could immediately improve stature recovery during prolonged sitting. Twenty-four patients with chronic low back pain (CLBP) were randomly allocated into different orders of experimental conditions: control (sitting without ADIM technique) and intervention conditions (sitting with ADIM technique). The latter condition required participants to complete ADIM technique for 1-minute and repeat it three times throughout 41-minute prolonged sitting time. Stature recovery was improved by 3.292 mm in the intervention condition compared with control condition (p-value =0.001). Our finding demonstrated that ADIM technique improved stature recovery. Practitioner Summary:  Prolonged sitting seemingly harms sedentary workers' health, particularly affecting the lower back. Activation of deep trunk muscles using abdominal drawing-in maneuver technique can promote spinal recovery. Clinicians can teach abdominal drawing-in maneuver technique to activate deep trunk muscles in chronic low back pain, thereby promoting self-management of seated stature recovery.",2020,Stature recovery was improved by 3.292 mm in the intervention condition compared with control condition (p-value =0.001).,"['Twenty-four patients with chronic low back pain (CLBP', 'seated sedentary workers with chronic low back pain']","['abdominal drawing-in maneuver technique', 'experimental conditions: control (sitting without ADIM technique) and intervention conditions (sitting with ADIM technique']","['stature recovery', 'Stature recovery']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]","[{'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}]",24.0,0.0123001,Stature recovery was improved by 3.292 mm in the intervention condition compared with control condition (p-value =0.001).,"[{'ForeName': 'Pongsatorn', 'Initials': 'P', 'LastName': 'Saiklang', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand.'}, {'ForeName': 'Rungthip', 'Initials': 'R', 'LastName': 'Puntumetakul', 'Affiliation': 'School of Physical Therapy, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand.'}, {'ForeName': 'Manida', 'Initials': 'M', 'LastName': 'Swangnetr Neubert', 'Affiliation': 'Research Center in Back, Neck, Other Joint Pain and Human Performance (BNOJPH), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Boucaut', 'Affiliation': 'International Centre for Allied Health Evidence, University of South Australia, Adelaide, Australia.'}]",Ergonomics,['10.1080/00140139.2020.1810326']
2257,32799770,Progress monitoring with couple clients.,"Objective:  The purpose of this paper was to assess differences in treatment progress in couple who were in a treatment as usual condition or a progress monitoring condition. Previous research has suggested that progress monitoring is useful for couples, but that research did not include change in relationship satisfaction over time.  Method : Using a sample of 130 couples who sought services at an on-campus training clinic, treatment satisfaction, progress, alliance and relationship satisfaction data over the first four sessions of treatment were analyzed with couples in two conditions. In the treatment as usual condition, neither the couple nor their therapist were provided with that information. In the feedback condition, the therapist shared the after-session feedback data in the form of graphs with the couple.  Results:  The results were mixed. There was little evidence that the feedback condition resulted in clients staying in treatment longer or ending treatment with agreement more often than clients in the TAU condition. Increases in relationship satisfaction, especially for female partners, were decreased in the feedback condition when male partners had higher trauma scores..  Conclusion:  It may be important for clinicians to consider what information they share with couple clients when using progress monitoring.",2020,"Increases in relationship satisfaction, especially for female partners, were decreased in the feedback condition when male partners had higher trauma scores..  ","['130 couples who sought services at an on-campus training clinic, treatment satisfaction, progress, alliance and relationship satisfaction data over the first four sessions of treatment were analyzed with couples in two conditions']",[],"['clients staying', 'relationship satisfaction']","[{'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],"[{'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",130.0,0.0320196,"Increases in relationship satisfaction, especially for female partners, were decreased in the feedback condition when male partners had higher trauma scores..  ","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Bartle-Haring', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Ohio, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Vanbergen', 'Affiliation': 'Department of Human Sciences, The Ohio State University, Ohio, USA.'}]",Psychotherapy research : journal of the Society for Psychotherapy Research,['10.1080/10503307.2020.1804640']
2258,32799781,Older Adults' Responses to a Meaningful Activity Using Indoor-Based Nature Experiences: Bird Tales.,"OBJECTIVES


Bird Tales is a meaningful activity that creates indoor-based nature experiences for older adults in residential care. This study examined the impact of Bird Tales by understanding what attributes of birds take on meaning to older adults and piloting the program to assess the psychosocial impact on older adults in an assisted living facility.
METHODS


We conducted a mixed-methods study. First, we conducted focus groups with older adults. Then we used a cross-over study design with random assignment to examine the impact of the program. Potential benefits of the program were examined using individual interviews and repeated measures on psychosocial questionnaires with a paired samples t-test to compare means from pretest and posttest within the intervention group.
RESULTS


Findings from the focus group indicate multisensory, spiritual, and therapeutic aspects of birds that hold meaning for older adults. The participants in Bird Tales shared positive experiences with the program by discussing cognitively stimulating activity, interactions with others, connections to the past, and positive perceptions of birds and nature.
CONCLUSIONS


Findings from our study suggest the potential of Bird Tales as a meaningful activity for older adults in residential care settings. We discuss implications for research as well as practice and present our recommendations.
CLINICAL IMPLICATIONS


Activities in long-term care should be meaningful to meet the psychological and social needs of older adults. Older adults enjoy and may benefit from indoor-based nature activities.",2020,"The participants in Bird Tales shared positive experiences with the program by discussing cognitively stimulating activity, interactions with others, connections to the past, and positive perceptions of birds and nature.
","['groups with older adults', 'older adults in residential care settings', 'older adults in residential care', 'Older adults', 'older adults in an assisted living facility']",[],"['multisensory, spiritual, and therapeutic aspects of birds that hold meaning']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]",[],"[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005595', 'cui_str': 'Class Aves'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}]",,0.0159739,"The participants in Bird Tales shared positive experiences with the program by discussing cognitively stimulating activity, interactions with others, connections to the past, and positive perceptions of birds and nature.
","[{'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Lee', 'Affiliation': 'School of Social Work, University of Texas at Arlington.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cassidy', 'Affiliation': 'School of Social Work, University of Texas at Arlington.'}, {'ForeName': 'Weizhou', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Leonard Davis School of Gerontology, University of Southern California.'}, {'ForeName': 'Venieca', 'Initials': 'V', 'LastName': 'Kusek', 'Affiliation': 'School of Social Work, University of Texas at Arlington.'}]",Clinical gerontologist,['10.1080/07317115.2020.1808869']
2259,32799791,Randomized crossover trial comparing cervical spine motion during tracheal intubation with a Macintosh laryngoscope versus a C-MAC D-blade videolaryngoscope in a simulated immobilized cervical spine.,"BACKGROUND


Maintaining cervical immobilization is essential during tracheal intubation in patients with unstable cervical spines. When using the Macintosh laryngoscope for intubation in patients with cervical immobilization, substantial neck extension is required for visualization of the glottis. However, the C-MAC D-Blade videolaryngoscope may require less neck extension due to its acute angulation. We hypothesized that C-MAC D-Blade videolaryngoscopic intubation would result in less cervical spine movement than Macintosh laryngoscopic intubation. We compared the effects of C-MAC D-Blade videolaryngoscopic intubation and Macintosh laryngoscopic intubation in terms of cervical spine motion during intubation in patients with simulated cervical immobilization.
METHODS


In this randomized crossover study, the cervical spine angle was measured at the occiput-C1, C1-C2, and C2-C5 segments before and during tracheal intubation with either a C-MAC D-Blade videolaryngoscope or Macintosh laryngoscope in 20 patients, with application of a neck collar for simulated cervical immobilization. Cervical spine motion was defined as the change in angle measured before and during tracheal intubation.
RESULTS


The cervical spine motion at the occiput-C1 segment was measured at 12.1 ± 4.2° and 6.8 ± 5.0° during Macintosh laryngoscopic and C-MAC D-blade videolaryngoscopic intubation, respectively, corresponding to a 44% reduction in cervical spine motion when using the latter device (mean difference, - 5.3; 98.33% CI: - 8.8 to - 1.8; p = 0.001). However, there was no significant difference between the two intubation devices at the C1-C2 segment (- 0.6; 98.33% CI: - 3.4 to 2.2; p = 0.639) or C2-C5 segment (0.2; 98.33% CI: - 6.0 to 6.4; p = 0.929).
CONCLUSIONS


The C-MAC D-Blade videolaryngoscope causes less upper cervical spine motion than the Macintosh laryngoscope during tracheal intubation of patients with simulated cervical immobilization.
TRIAL REGISTRATION


This study was registered at ClinicalTrials.gov on June 26, 2018 ( NCT03567902 ).",2020,"The C-MAC D-Blade videolaryngoscope causes less upper cervical spine motion than the Macintosh laryngoscope during tracheal intubation of patients with simulated cervical immobilization.
","['20 patients, with application of a neck collar for simulated cervical immobilization', 'patients with unstable cervical spines', 'patients with cervical immobilization', 'patients with simulated cervical immobilization']","['C-MAC D-Blade videolaryngoscope or Macintosh laryngoscope', 'cervical spine motion during tracheal intubation with a Macintosh laryngoscope versus a C-MAC D-blade videolaryngoscope', 'C-MAC D-Blade videolaryngoscopic intubation', 'Macintosh laryngoscope', 'C-MAC D-Blade videolaryngoscopic intubation and Macintosh laryngoscopic intubation']","['cervical spine motion', 'cervical spine movement', 'Cervical spine motion']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0175751', 'cui_str': 'Cervical collar'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0443343', 'cui_str': 'Unstable status'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}]","[{'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}]","[{'cui': 'C0728985', 'cui_str': 'Structure of cervical vertebral column'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",,0.0783557,"The C-MAC D-Blade videolaryngoscope causes less upper cervical spine motion than the Macintosh laryngoscope during tracheal intubation of patients with simulated cervical immobilization.
","[{'ForeName': 'Hyesun', 'Initials': 'H', 'LastName': 'Paik', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Armed Forces Capital Hospital, 81, Saemaul-ro 177 gil, Bundang-gu, Seongnam, 13590, South Korea.'}, {'ForeName': 'Hee-Pyoung', 'Initials': 'HP', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Seoul National University Hospital, Seoul National University College of Medicine, 101, Daehak-ro, Jongno-gu, Seoul, 03080, South Korea. hppark@snu.ac.kr.'}]",BMC anesthesiology,['10.1186/s12871-020-01118-3']
2260,32799792,Ketorolac tromethamine pretreatment suppresses sufentanil-induced cough during general anesthesia induction: a prospective randomized controlled trial.,"BACKGROUND


To observe the effect of pretreatment with ketorolac tromethamine on sufentanil-induced cough in general anesthesia patients.
METHODS


A total of 102 patients were screened, and 90 patients were scheduled for elective surgery under general anesthesia. The 90 patients were randomly divided into two groups: the control group (C group) and the observation group (KT group). Five minutes before anesthesia induction, the observation group was given ketorolac tromethamine 0.5 mg/kg intravenously within 3 s, while the control group was given the same amount of normal saline intravenously. All patients were given a sufentanil bolus of 0.5 μg/kg (within 3 s) intravenously. One minute later, propofol 2.5 mg/kg and vecuronium 0.15 mg/kg were injected intravenously, and endotracheal intubation was guided by laryngoscopy. The number of coughs that occurred within 1 min after sufentanil injection was recorded. The mean arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO 2 ) were recorded at T0 (immediately before pretreatment), T1 (5 min after pretreatment), T2 (before intubation), T3 (1 min after intubation) and T4 (5 min after intubation). The incidence of adverse reactions, including nausea and vomiting, dizziness, drowsiness, delay of recovery, restlessness in the recovery period, respiratory depression and postoperative incision pain, was analyzed.
RESULTS


Within 1 min after sufentanil injection, the incidence and severity of cough in the KT group was significantly lower than that in the C group (P <  0.05). At T0, T1, T2, T3 and T4, there were no significant differences in MAP, HR and SpO2 between the two groups (P >  0.05). There was no significant difference in the dosage of sufentanil, propofol, remifentanil and vecuronium, the incidence of nausea and vomiting, the delay of recovery, dizziness, drowsiness or respiratory depression between the two groups (P >  0.05). However, the incidence of restlessness and the number of patients with VAS scores > 3 in the KT group were significantly lower than those in the C group (P <  0.05).
CONCLUSION


Pretreatment with intravenous ketorolac tromethamine can significantly reduce the incidence of sufentanil-induced cough during induction of general anesthesia, which can also significantly reduce postoperative incision pain and restlessness during the recovery period.
TRIAL REGISTRATION


Chinese Clinical Trial Registry (registration number# ChiCTR2000030287 ; date of registration: 27/02/2020).",2020,"At T0, T1, T2, T3 and T4, there were no significant differences in MAP, HR and SpO2 between the two groups (P >  0.05).","['102 patients were screened, and 90 patients were scheduled for elective surgery under general anesthesia', 'induced cough during general anesthesia induction', '90 patients', 'general anesthesia patients']","['ketorolac tromethamine', 'sufentanil', 'propofol 2.5\u2009mg/kg and vecuronium', 'Ketorolac tromethamine']","['dosage of sufentanil, propofol, remifentanil and vecuronium, the incidence of nausea and vomiting, the delay of recovery, dizziness, drowsiness or respiratory depression', 'incidence of restlessness and the number of patients with VAS scores', 'postoperative incision pain and restlessness', 'incidence and severity of cough', 'MAP, HR and SpO2', 'incidence of adverse reactions, including nausea and vomiting, dizziness, drowsiness, delay of recovery, restlessness in the recovery period, respiratory depression and postoperative incision pain', 'mean arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO 2 ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0064326', 'cui_str': 'Ketorolac tromethamine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0242531', 'cui_str': 'Vecuronium'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0242531', 'cui_str': 'Vecuronium'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}]",102.0,0.140587,"At T0, T1, T2, T3 and T4, there were no significant differences in MAP, HR and SpO2 between the two groups (P >  0.05).","[{'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Tian', 'Affiliation': ""Department of Anesthesiology, Suqian People's Hospital of Nanjing Drum-tower Hospital Group, Suqian, 223800, China.""}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': ""Department of Anesthesiology, Suqian People's Hospital of Nanjing Drum-tower Hospital Group, Suqian, 223800, China. sqrmyyhb@163.com.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Miao', 'Affiliation': ""Department of Anesthesiology, Suqian People's Hospital of Nanjing Drum-tower Hospital Group, Suqian, 223800, China.""}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, Suqian People's Hospital of Nanjing Drum-tower Hospital Group, Suqian, 223800, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""Department of Anesthesiology, Suqian People's Hospital of Nanjing Drum-tower Hospital Group, Suqian, 223800, China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, Suqian People's Hospital of Nanjing Drum-tower Hospital Group, Suqian, 223800, China.""}]",BMC anesthesiology,['10.1186/s12871-020-01124-5']
2261,32799871,A randomised controlled pilot trial of the influence of non-native English accents on examiners' scores in OSCEs.,"BACKGROUND


Objective structured clinical examinations (OSCEs) are important aspects of assessment in medical education. There is anecdotal evidence suggesting that students with non-native English accents (NNEA) may be subjected to unconscious bias. It is imperative to minimise the examiners' bias so that the difference in the scores reflects students' clinical competence. Research shows NNEAs can cause stereotyping, often leading to the speaker being negatively judged. However, no medical education study has looked at the influence of NNEAs in assessment.
METHODS


This is a randomized, single-blinded controlled trial. Four videos of one mock OSCE station were produced. A professional actor played a medical student. Two near identical scripts were prepared. Two videos showed the actor speaking with an Indian accent and two videos showed the actor speaking without the accent in either script. Forty-two OSCE examiners in the United Kingdom (UK) were recruited and randomly assigned to two groups. They watched two videos online, each with either script, each with a different script. One video with a NNEA and one video was without. Checklist item scores were analysed with descriptive statistics and non-parametric independent samples median test. Global scores were analysed with descriptive statistics and Mann-Whitney test.
RESULTS


Thirty-two examiners completed the study. The average scores for the checklist items (41.6 points) did not change when the accent variable was changed. Independent samples median test showed no statistically significant relationship between the accent and the scores (p = 0.787). For the global scores received by the videos with the NNEA, there were one less 'Good' grade and one more 'Fail' grade compared to those without the NNEA. Mann-Whitney test on global score showed lower scores for videos with NNEA (p = 0.661).
CONCLUSIONS


Examiners were not biased either positively or negatively towards NNEAs when providing checklist or global scores. Further study is required to validate the findings of this study. More discussion is warranted to consider how the accent should be considered in current medical education assessment.
REGISTRATION


Trial registration completed trial, ID: ISRCTN17360102, Retrospectively registered on 15/04/2020.",2020,"Mann-Whitney test on global score showed lower scores for videos with NNEA (p = 0.661).
","['Thirty-two examiners completed the study', 'Forty-two OSCE examiners in the United Kingdom (UK']",[],"['actor speaking', 'Global scores', 'Checklist item scores']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}]",[],"[{'cui': 'C0335083', 'cui_str': 'Actor'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0559741', 'cui_str': 'Item score'}]",1.0,0.0565578,"Mann-Whitney test on global score showed lower scores for videos with NNEA (p = 0.661).
","[{'ForeName': 'An', 'Initials': 'A', 'LastName': 'Kozato', 'Affiliation': 'Queen Mary University of London, Centre for Medical Education, Institute of Health Sciences Education, Barts and The London School of Medicine & Dentistry, Garrod Building, Turner Street, London, UK.'}, {'ForeName': 'Nimesh', 'Initials': 'N', 'LastName': 'Patel', 'Affiliation': 'Queen Mary University of London, Centre for Medical Education, Institute of Health Sciences Education, Barts and The London School of Medicine & Dentistry, Garrod Building, Turner Street, London, UK.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Shikino', 'Affiliation': 'Department of General Medicine, Chiba University Hospital, 1-8-1, Inohana, Chuo-ku, Chiba-city, Chiba, Japan. kshikino@gmail.com.'}]",BMC medical education,['10.1186/s12909-020-02198-y']
2262,32799920,Yields and costs of recruitment methods with participant phenotypic characteristics for a diabetes prevention research study in an underrepresented pediatric population.,"BACKGROUND/AIMS


Prediabetes and diabetes disproportionately impact Latino youth, yet few diabetes prevention programs have prioritized inclusion of this underrepresented population. This report describes the recruitment process, yields, associated costs, and phenotypic characteristics of Latino youth with obesity and prediabetes enrolled in a randomized controlled diabetes prevention study in the USA.
METHODS


Recruitment efforts included referrals from clinics, community outlets, local media, and word of mouth with the goal of enrolling 120 Latino adolescents aged 12-16 with obesity (BMI > 95th percentile) and prediabetes. Prediabetes eligibility was determined by any of the following: HbA1c between 5.7 and 6.5%, fasting glucose between 100 and 125 mg/dL, or a 2-h glucose between 120 and 199 mg/dL following a 75-g oral glucose tolerance test (OGTT), but not meeting any of the diagnostic criteria for diabetes. Eligible participants were randomized 2:1 to either a 6-month community-based lifestyle intervention that included group nutrition and health education classes (1 day/week) and group exercise classes (2 days/week) or usual care control arm. Recruitment yields were determined by review of referral source in the study screening database. Recruitment costs were determined by an after-the-fact financial review of actual and in-kind costs. Participant phenotypic characteristics (i.e., demographics, anthropometrics, and biochemical data) were compared by recruitment strategy using a one-way ANOVA.
RESULTS


Recruitment efforts covered 160 mile 2  (414 km 2 ) across 26 ZIP codes (postcode) in the Phoenix Metropolitan Area and yielded 655 referrals from clinics (n = 344), community (n = 143), media (n = 137), and word-of-mouth (n = 31). From this pool, 26% (n = 167) did not meet general, pre-screening eligibility criteria; 29% (n = 187) declined participation; and 10% (n = 64) were unable to be contacted. A total of 237 youth were invited to the clinical research unit to determine final eligibility. Following the OGTT, 52% (n = 122) met prediabetes criteria and 117 were subsequently randomized. Clinical recruitment yielded the highest number of referrals (53%; n = 344) while word-of-mouth yielded the highest proportion (35%; n = 11) of randomized participants per referred youth. There were no significant differences in anthropometric or biochemical measures among youth by recruitment strategy. Based upon final enrollment numbers, community recruitment was the costliest approach ($486/randomized participant) followed by clinical ($248/randomized participant) and media ($236/randomized participant).
CONCLUSIONS


The ability to meet enrollment goals for a clinical trial of an underrepresented population required multiple recruitment strategies. Although strategies vary in yields and costs, it appears they produce similar phenotypical risk profiles of eligible youth.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02615353 . Registered on 26 November 2015.",2020,while word-of-mouth yielded the highest proportion (35%; n = 11) of randomized participants per referred youth.,"['52% (n\xa0=\u2009122) met prediabetes criteria and 117 were subsequently randomized', 'Eligible participants', '344', 'A total of 237 youth were invited to the clinical research unit to determine final eligibility', 'Latino youth with obesity and prediabetes enrolled', 'underrepresented pediatric population', 'Recruitment efforts included referrals from clinics, community outlets, local media, and word of mouth with the goal of enrolling 120 Latino adolescents aged 12-16 with obesity (BMI >\u200995th percentile) and prediabetes']",['6-month community-based lifestyle intervention that included group nutrition and health education classes (1\u2009day/week) and group exercise classes (2\u2009days/week) or usual care control arm'],"['anthropometric or biochemical measures', 'Recruitment costs', 'fasting glucose', 'Participant phenotypic characteristics (i.e., demographics, anthropometrics, and biochemical data']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",120.0,0.167884,while word-of-mouth yielded the highest proportion (35%; n = 11) of randomized participants per referred youth.,"[{'ForeName': 'Kiley B', 'Initials': 'KB', 'LastName': 'Vander Wyst', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Micah L', 'Initials': 'ML', 'LastName': 'Olson', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Elva', 'Initials': 'E', 'LastName': 'Hooker', 'Affiliation': 'Ivy Center for Family Wellness, The Society of St. Vincent de Paul of Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Erica G', 'Initials': 'EG', 'LastName': 'Soltero', 'Affiliation': ""USDA/ARS Children's Research Center, Baylor College of Medicine, Houston, TX, USA.""}, {'ForeName': 'Yolando P', 'Initials': 'YP', 'LastName': 'Konopken', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Colleen S', 'Initials': 'CS', 'LastName': 'Keller', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Felipe G', 'Initials': 'FG', 'LastName': 'Castro', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Allison N', 'Initials': 'AN', 'LastName': 'Williams', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Arlene D R', 'Initials': 'ADR', 'LastName': 'Fernández', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Patrick', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Ayers', 'Affiliation': 'Southwest Interdisciplinary Research Center, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Houchun H', 'Initials': 'HH', 'LastName': 'Hu', 'Affiliation': 'Hyperfine Research, Inc., Guilford, CT, USA.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Peña', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Janiel', 'Initials': 'J', 'LastName': 'Pimentel', 'Affiliation': ""Division of Pediatric Endocrinology and Diabetes, Phoenix Children's Hospital, Phoenix, AZ, USA.""}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Diabetes Epidemiology and Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ, USA.'}, {'ForeName': 'Gabriel Q', 'Initials': 'GQ', 'LastName': 'Shaibi', 'Affiliation': 'Center for Health Promotion and Disease Prevention, Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, AZ, USA. Gabriel.shaibi@asu.edu.'}]",Trials,['10.1186/s13063-020-04658-8']
2263,32799922,"Cortical priming strategies for gait training after stroke: a controlled, stratified trial.","BACKGROUND


Stroke survivors experience chronic gait impairments, so rehabilitation has focused on restoring ambulatory capacity. High-intensity speed-based treadmill training (HISTT) is one form of walking rehabilitation that can improve walking, but its effectiveness has not been thoroughly investigated. Additionally, cortical priming with transcranial direct current stimulation (tDCS) and movement may enhance HISTT-induced improvements in walking, but there have been no systematic investigations. The objective of this study was to determine if motor priming can augment the effects of HISTT on walking in chronic stroke survivors.
METHODS


Eighty-one chronic stroke survivors participated in a controlled trial with stratification into four groups: 1) control-15 min of rest (n = 20), 2) tDCS-15 min of stimulation-based priming with transcranial direct current stimulation (n = 21), 3) ankle motor tracking (AMT)-15 min of movement-based priming with targeted movements of the ankle and sham tDCS (n = 20), and 4) tDCS+AMT-15 min of concurrent tDCS and AMT (n = 20). Participants performed 12 sessions of HISTT (40 min/day, 3 days/week, 4 weeks). Primary outcome measure was walking speed. Secondary outcome measures included corticomotor excitability (CME). Outcomes were measured at pre, post, and 3-month follow-up assessments.
RESULTS


HISTT improved walking speed for all groups, which was partially maintained 3 months after training. No significant difference in walking speed was seen between groups. The tDCS+AMT group demonstrated greater changes in CME than other groups. Individuals who demonstrated up-regulation of CME after tDCS increased walking speed more than down-regulators.
CONCLUSIONS


Our results support the effectiveness of HISTT to improve walking; however, motor priming did not lead to additional improvements. Upregulation of CME in the tDCS+AMT group supports a potential role for priming in enhancing neural plasticity. Greater changes in walking were seen in tDCS up-regulators, suggesting that responsiveness to tDCS might play an important role in determining the capacity to respond to priming and HISTT.
TRIAL REGISTRATION


ClinicalTrials.gov , NCT03492229. Registered 10 April 2018 - retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03492229 .",2020,No significant difference in walking speed was seen between groups.,"['chronic stroke survivors', 'gait training after stroke', 'Eighty-one chronic stroke survivors participated in a controlled trial with stratification into four groups: 1', 'Registered 10 April 2018 - retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03492229 ']","['transcranial direct current stimulation (tDCS', 'tDCS+AMT', 'High-intensity speed-based treadmill training (HISTT', 'control-15\u2009min of rest (n\u2009=\u200920), 2) tDCS-15\u2009min of stimulation-based priming with transcranial direct current stimulation (n\u2009=\u200921), 3) ankle motor tracking (AMT)-15\u2009min of movement-based priming with targeted movements of the ankle and sham tDCS (n\u2009=\u200920), and 4) tDCS+AMT-15\u2009min of concurrent tDCS and AMT', 'HISTT']","['walking speed', 'corticomotor excitability (CME', 'CME']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4517884', 'cui_str': '81'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0331021', 'cui_str': 'Ligustrum vulgare'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0063517', 'cui_str': 'indopan'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}]",,0.106953,No significant difference in walking speed was seen between groups.,"[{'ForeName': 'Sangeetha', 'Initials': 'S', 'LastName': 'Madhavan', 'Affiliation': 'Department of Physical Therapy, Brain Plasticity Lab, University of Illinois at Chicago, 1919 W. Taylor St, Chicago, IL, 60612, USA. smadhava@uic.edu.'}, {'ForeName': 'Brice T', 'Initials': 'BT', 'LastName': 'Cleland', 'Affiliation': 'Department of Physical Therapy, Brain Plasticity Lab, University of Illinois at Chicago, 1919 W. Taylor St, Chicago, IL, 60612, USA.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Sivaramakrishnan', 'Affiliation': 'Department of Physical Therapy, Brain Plasticity Lab, University of Illinois at Chicago, 1919 W. Taylor St, Chicago, IL, 60612, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Freels', 'Affiliation': 'University of Illinois at Chicago, Epidemiology and Biostatistics, Chicago, IL, USA.'}, {'ForeName': 'Hyosok', 'Initials': 'H', 'LastName': 'Lim', 'Affiliation': 'Department of Physical Therapy, Brain Plasticity Lab, University of Illinois at Chicago, 1919 W. Taylor St, Chicago, IL, 60612, USA.'}, {'ForeName': 'Fernando D', 'Initials': 'FD', 'LastName': 'Testai', 'Affiliation': 'University of Illinois at Chicago, Department of Neurology and Rehabilitation, Chicago, IL, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Corcos', 'Affiliation': 'Northwestern University, Physical Therapy & Human Movement Sciences, Chicago, IL, USA.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00744-9']
2264,32799933,Efficacy of dexamethasone treatment for patients with the acute respiratory distress syndrome caused by COVID-19: study protocol for a randomized controlled superiority trial.,"BACKGROUND


There are no specific generally accepted therapies for the coronavirus disease 2019 (COVID-19). The full spectrum of COVID-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multisystem organ failure, and death. The efficacy of corticosteroids in viral ARDS remains unknown. We postulated that adjunctive treatment of established ARDS caused by COVID-19 with intravenous dexamethasone might change the pulmonary and systemic inflammatory response and thereby reduce morbidity, leading to a decrease in duration of mechanical ventilation and in mortality.
METHODS/DESIGN


This is a multicenter, randomized, controlled, parallel, open-label, superiority trial testing dexamethasone in 200 mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed SARS-CoV-2 infection. Established ARDS is defined as maintaining a PaO 2 /FiO 2  ≤ 200 mmHg on PEEP ≥ 10 cmH 2 O and FiO 2  ≥ 0.5 after 12 ± 3 h of routine intensive care. Eligible patients will be randomly assigned to receive either dexamethasone plus standard intensive care or standard intensive care alone. Patients in the dexamethasone group will receive an intravenous dose of 20 mg once daily from day 1 to day 5, followed by 10 mg once daily from day 6 to day 10. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days, defined as days alive and free from mechanical ventilation at day 28 after randomization. All analyses will be done according to the intention-to-treat principle.
DISCUSSION


This study will assess the role of dexamethasone in patients with established moderate-to-severe ARDS caused by SARS-CoV-2.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04325061 . Registered on 25 March 2020 as DEXA-COVID19.",2020,"The secondary outcome is the number of ventilator-free days, defined as days alive and free from mechanical ventilation at day 28 after randomization.","['200 mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed SARS-CoV-2 infection', 'patients with established moderate-to-severe ARDS caused by SARS-CoV-2', 'patients with the acute respiratory distress syndrome caused by COVID-19', 'Eligible patients']","['dexamethasone', 'corticosteroids', 'dexamethasone plus standard intensive care or standard intensive care alone']","['duration of mechanical ventilation and in mortality', 'pulmonary and systemic inflammatory response', 'number of ventilator-free days, defined as days alive and free from mechanical ventilation', '60-day mortality']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0035222', 'cui_str': 'Acute respiratory distress syndrome'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2584946', 'cui_str': 'Alive'}]",,0.322383,"The secondary outcome is the number of ventilator-free days, defined as days alive and free from mechanical ventilation at day 28 after randomization.","[{'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Villar', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain. jesus.villar54@gmail.com.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Añón', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Ferrando', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Gerardo', 'Initials': 'G', 'LastName': 'Aguilar', 'Affiliation': 'Department of Anesthesia, Hospital Clínico Universitario, Valencia, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Muñoz', 'Affiliation': 'Intensive Care Unit, Hospital Universitario de Cruces, Barakaldo, Vizcaya, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Ferreres', 'Affiliation': 'Intensive Care Unit, Hospital Clínico Universitario, Valencia, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Ambrós', 'Affiliation': 'Intensive Care Unit, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Aldecoa', 'Affiliation': 'Department of Anesthesia, Hospital Universitario Río Hortega, Valladolid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Suárez-Sipmann', 'Affiliation': 'CIBER de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': 'Applied Health Research Center, Li Ka Shing Knowledge Institute, Toronto, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': 'Applied Health Research Center, Li Ka Shing Knowledge Institute, Toronto, Canada.'}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Slutsky', 'Affiliation': ""Keenan Research Center for Biomedical Science at the Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04643-1']
2265,32799960,Comparison of gustatory function between mucosal and squamous disease: a randomised controlled study.,"OBJECTIVE


The aim of this study was to evaluate and compare the gustatory function between patients with chronic mucosal and squamous diseases before and after the surgery.
METHOD


A total of 33 patients with mucosal diseases and 34 patients with squamous diseases were evaluated for gustatory function both in the pre-operative and post-operative periods. The taste scores were compared between the two groups.
RESULTS


The gustatory scores in the mucosal disease group were significantly better than the scores in the squamous disease group (p < 0.05). There was no significant correlation detected between the age of the patients or duration of the disease with the taste scores in any of the study groups.
CONCLUSION


The improvement in gustatory score was better in the chronic mucosal disease group than the squamous disease group. There was no significant correlation found between the age of the patients or duration of disease and the taste score in any of the study groups.",2020,The gustatory scores in the mucosal disease group were significantly better than the scores in the squamous disease group (p < 0.05).,"['patients with chronic mucosal and squamous diseases before and after the surgery', '33 patients with mucosal diseases and 34 patients with squamous diseases', 'mucosal and squamous disease']",[],"['duration of disease and the taste score', 'gustatory scores', 'gustatory score', 'gustatory function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0151785', 'cui_str': 'Disorder of mucous membrane'}]",[],"[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439678', 'cui_str': 'Gustatory'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",33.0,0.0251698,The gustatory scores in the mucosal disease group were significantly better than the scores in the squamous disease group (p < 0.05).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Anant', 'Affiliation': 'Department of ENT and Head Neck Surgery, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lal', 'Affiliation': 'Department of ENT and Head Neck Surgery, Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pradhan', 'Affiliation': 'Department of ENT and Head Neck Surgery, All India Institute of Medical Sciences, Bhubaneswar, India.'}]",The Journal of laryngology and otology,['10.1017/S0022215120001619']
2266,32804602,"The effects of ""Workplace Health Promotion Program"" in nurses: A randomized controlled trial and one-year follow-up.","In this study, the authors examined the effects of the ""Workplace Health Promotion Program"" (WHPP) on pain, fatigue, stress, professional quality of life (Pro-QoL), and coping skills for nurses. The authors conducted a randomized control trial in 30 nurses who agreed to participate in this study. Progressive relaxation training, posture and breath exercises, and ergonomic suggestions as a WHPP were applied to the intervention group ( n  = 15) during the five weeks. The intervention group showed decrease in pain ( p  = .001), fatigue ( p  = .001), and stress levels ( p  = .003) and increase in coping skills and Pro-QoL ( p  < .05). In contrast, the authors observed no improvement in the control group. The authors concluded at the end of the study that WHPP remains effective in nurses.",2020,"The intervention group showed decrease in pain ( p  = .001), fatigue ( p  = .001), and stress levels ( p  = .003) and increase in coping skills and Pro-QoL ( p  < .05).","['nurses', '30 nurses who agreed to participate in this study']","['WHPP', 'Workplace Health Promotion Program"" (WHPP', 'Progressive relaxation training, posture and breath exercises, and ergonomic suggestions', 'Workplace Health Promotion Program']","['fatigue', 'coping skills and Pro-QoL', 'stress levels', 'pain, fatigue, stress, professional quality of life (Pro-QoL), and coping skills for nurses', 'pain']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0086246', 'cui_str': 'Human Engineering'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]",30.0,0.0280078,"The intervention group showed decrease in pain ( p  = .001), fatigue ( p  = .001), and stress levels ( p  = .003) and increase in coping skills and Pro-QoL ( p  < .05).","[{'ForeName': 'Gokcen', 'Initials': 'G', 'LastName': 'Akyurek', 'Affiliation': 'Faculty of Health Sciences, Department of Occupational Therapy, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Nergis', 'Initials': 'N', 'LastName': 'Avci', 'Affiliation': 'Faculty of Health Sciences, Department of Occupational Therapy, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Ekici', 'Affiliation': 'Faculty of Health Sciences, Department of Occupational Therapy, Hacettepe University, Ankara, Turkey.'}]",Health care for women international,['10.1080/07399332.2020.1800013']
2267,32804616,Surgical Comanagement for Hip Fracture: Time for a Randomized Trial.,,2020,,['Hip Fracture'],['Surgical Comanagement'],[],"[{'cui': 'C0019557', 'cui_str': 'Hip fracture'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}]",[],,0.0303778,,"[{'ForeName': 'Corita', 'Initials': 'C', 'LastName': 'Vincent', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cram', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Canada.'}]",Journal of hospital medicine,['10.12788/jhm.3415']
2268,32804621,Feasibility and Preliminary Efficacy of an Occupational Therapy Intervention for Older Adults With Chronic Conditions in a Primary Care Clinic.,"IMPORTANCE


Occupational therapy can play a role in primary care management of chronic diseases among older adults.
OBJECTIVE


To assess the feasibility of delivering a primary care occupation-focused intervention (Integrated PRimary care and Occupational therapy for Aging and Chronic disease Treatment to preserve Independence and Functioning, or i-PROACTIF) for older adults with chronic disease.
DESIGN


Feasibility study comparing i-PROACTIF with complex care management using a two-group randomized controlled trial design with data gathered at baseline and during and after the 8-wk intervention.
SETTING


Family medicine clinic serving an urban, low-income, working-class community.
OUTCOMES AND MEASURES


Feasibility indicators were recruitment, retention, utility of clinical assessments, and acceptability of interventions assessed through feedback surveys completed by patients and primary care providers (PCPs). Patient outcomes, including perspectives on chronic illness care, occupational performance, and overall well-being, were collected using standardized, validated measures and analyzed descriptively.
PARTICIPANTS


Eighteen adult volunteers, ages ≥50 yr, with heart disease, arthritis, and uncontrolled diabetes completed the study. Ten PCPs completed feedback surveys.
INTERVENTION


i-PROACTIF focuses on preserving functional independence, is based on the Person-Environment-Occupation framework, and consists of two assessment sessions and six weekly treatment sessions.
RESULTS


Recruitment goals were achieved, with an 86% retention rate. Clinical measures unearthed deficits in areas that were unreported or underreported by patients. Participants reported being extremely satisfied with the intervention. Physicians and nurses also supported the intervention. Both groups showed improved scores on most outcomes.
CONCLUSION AND RELEVANCE


Delivering and evaluating i-PROACTIF was feasible and acceptable. Future efficacy trials are needed before it can be used in clinical settings.
WHAT THIS ARTICLE ADDS


The results of this study can inform future occupational therapy interventions and clinical trials in primary care for older adults with chronic conditions.",2020,"Both groups showed improved scores on most outcomes.
","['older adults', 'older adults with chronic disease', 'Eighteen adult volunteers, ages ≥50 yr, with heart disease, arthritis, and uncontrolled diabetes completed the study', 'Older Adults With Chronic Conditions in a Primary Care Clinic', 'Family medicine clinic serving an urban, low-income, working-class community', 'older adults with chronic conditions']","['Occupational Therapy Intervention', 'primary care occupation-focused intervention (Integrated PRimary care and Occupational therapy']","['chronic illness care, occupational performance, and overall well-being', 'recruitment, retention, utility of clinical assessments, and acceptability of interventions assessed through feedback surveys completed by patients and primary care providers (PCPs']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018799', 'cui_str': 'Heart disease'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C3833703', 'cui_str': 'Family medicine clinic'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}]","[{'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}]",18.0,0.0285227,"Both groups showed improved scores on most outcomes.
","[{'ForeName': 'Mansha', 'Initials': 'M', 'LastName': 'Mirza', 'Affiliation': 'Mansha Mirza, PhD, OTR/L, MSHSOR, is Associate Professor, Department of Occupational Therapy, University of Illinois at Chicago; mmirza2@uic.edu.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Gecht-Silver', 'Affiliation': 'Maureen Gecht-Silver, OTD, MPH, OTR/L, is Assistant Professor, Clinical Family Medicine and Clinical Occupational Therapy, and Associate Director, Medical Student Education, Department of Family Medicine, University of Illinois at Chicago.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Keating', 'Affiliation': 'Emily Keating, OTD, OTR/L, is Occupational Therapist, Chicago Public Schools, Chicago.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Krischer', 'Affiliation': 'Amy Krischer, OTD, OTR/L, is Occupational Therapist and Independent Early Intervention Contractor, Chicago.'}, {'ForeName': 'Hajwa', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Hajwa Kim, MS, is Associate Director, Biostatistics Core, Center for Clinical and Translational Science, University of Illinois at Chicago.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kottorp', 'Affiliation': 'Anders Kottorp, PhD, OT Reg, is Professor and Dean, Health and Society, University of Malmö, Malmö, Sweden.'}]",The American journal of occupational therapy : official publication of the American Occupational Therapy Association,['10.5014/ajot.2020.039842']
2269,32804742,Effect of pimavanserin on anxious depression in patients with major depression and an inadequate response to previous therapy: secondary analysis of the clarity study.,"In a post hoc analysis, the effect of pimavanserin on anxious depression was determined from CLARITY, a randomized, double-blind, placebo-controlled study in patients with major depression and an inadequate response to previous therapy. Patients were randomized in a 3:1 ratio to placebo or pimavanserin 34 mg daily added to ongoing antidepressant therapy. At 5 weeks, placebo nonresponders were rerandomized to placebo or pimavanserin for an additional 5 weeks. Mean change from baseline to week 5 for the Hamilton depression rating scale (HAMD) anxiety/somatization (AS) factor was examined for all patients and those with a score ≥7 at baseline. Least squares (LS) mean [standard error (SE)] difference between placebo and pimavanserin for the AS factor score was -1.5 (0.41) [95% confidence interval (CI) -2.4 to -0.7; P = 0.0003; effect size: 0.634]. Among patients with an AS factor score ≥7 at baseline, LS mean (SE) difference was -2.2 (0.66) (95% CI -3.5 to -0.9; P = 0.0013; effect size: 0.781). Response rates (≥50% reduction in HAMD-17 from baseline) were 22.4 and 55.2% (P = 0.0012) and remission rates (HAMD-17 total score <7) were 5.3 and 24.1% (P = 0.0047), respectively, with placebo and pimavanserin among patients with a baseline AS factor score ≥7. Among patients with anxious major depressive disorder at baseline, adjunctive pimavanserin was associated with a significant improvement.",2020,Mean change from baseline to week 5 for the Hamilton depression rating scale (HAMD) anxiety/somatization (AS) factor was examined for all patients and those with a score ≥7 at baseline.,"['patients with major depression and an inadequate response to previous therapy', 'patients with anxious major depressive disorder']","['placebo or pimavanserin', 'placebo and pimavanserin', 'pimavanserin', 'placebo']","['Least squares (LS) mean [standard error (SE)] difference', 'remission rates', 'Hamilton depression rating scale (HAMD) anxiety/somatization (AS) factor', 'anxious depression', 'Response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1722267', 'cui_str': 'pimavanserin'}]","[{'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}]",,0.419589,Mean change from baseline to week 5 for the Hamilton depression rating scale (HAMD) anxiety/somatization (AS) factor was examined for all patients and those with a score ≥7 at baseline.,"[{'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Shelton', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, The University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, the University of Pennsylvania and the Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'The University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Dirks', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}, {'ForeName': 'Srdjan', 'Initials': 'S', 'LastName': 'Stankovic', 'Affiliation': 'ACADIA Pharmaceuticals Inc., San Diego, California, USA.'}]",International clinical psychopharmacology,['10.1097/YIC.0000000000000328']
2270,32804875,Effect of the Helping Babies Breathe Training Program: An Experimental Study on Jordanian Midwives' Knowledge and Skills.,"The Helping Babies Breathe (HBB) training program trains providers in effective resuscitation of infants in developing countries. This study evaluated the effectiveness of the HBB training program on midwives' knowledge and skills in Northern Jordan. Using a nonequivalent control group design, 50 midwives (control, n = 25; experimental, n = 25) from 3 public hospitals in Northern Jordan were recruited and their knowledge and skills were evaluated before and after the training. The program has 3 aspects: 2 hours of teaching, 1 hour of testing, and 25 minutes of skills assessment per participant. The skills were tested individually for each participant, and they were reevaluated at 8 months after. The control and experimental groups significantly differed in posttest scores on knowledge, Objective Structured Clinical Examination A and B skills, and bag-mask application after adjusting for covariates. The HBB training program significantly enhanced knowledge of midwives in the experimental group (P < .05) and demonstrated skills. The HBB training program was helpful in improving midwives' knowledge and practices on immediate care of a newborn baby. Therefore, training midwives using the HBB training program can improve their knowledge and skills and thereby improve infant outcomes in Jordan.",2020,"The control and experimental groups significantly differed in posttest scores on knowledge, Objective Structured Clinical Examination A and B skills, and bag-mask application after adjusting for covariates.","[""midwives' knowledge and skills in Northern Jordan"", '50 midwives (control, n = 25; experimental, n = 25) from 3 public hospitals in Northern Jordan']","['HBB training program', 'Helping Babies Breathe Training Program']","['posttest scores on knowledge, Objective Structured Clinical Examination A and B skills, and bag-mask application', 'knowledge of midwives']","[{'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}]","[{'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}]",,0.013634,"The control and experimental groups significantly differed in posttest scores on knowledge, Objective Structured Clinical Examination A and B skills, and bag-mask application after adjusting for covariates.","[{'ForeName': 'Reem', 'Initials': 'R', 'LastName': 'Hatamleh', 'Affiliation': 'Faculty of Nursing (Dr Hatamleh) and Maternal and Child Health Department (Dr Abuhammad), Jordan University of Science and Technology, Irbid, Jordan; Faculty of Nursing, Hashemite University, Zarqa, Jordan (Dr Abujilban); Jordan University of Science and Technology, Irbid, Jordan (Mr Ariag); and Liberty University, Lynchburg, Virginia (Dr Joseph).'}, {'ForeName': 'Sanaa', 'Initials': 'S', 'LastName': 'Abujilban', 'Affiliation': ''}, {'ForeName': 'Sawsan', 'Initials': 'S', 'LastName': 'Abuhammad', 'Affiliation': ''}, {'ForeName': 'Dalal Mohammad Ahmad', 'Initials': 'DMA', 'LastName': 'Ariag', 'Affiliation': ''}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Joseph', 'Affiliation': ''}]",The Journal of perinatal & neonatal nursing,['10.1097/JPN.0000000000000485']
2271,32804876,Comparing the Analgesic Effects of 4 Nonpharmacologic Interventions on Term Newborns Undergoing Heel Lance: A Randomized Controlled Trial.,"This randomized trial compared the analgesic effect of 4 nonpharmacologic interventions (breastfeeding, oral sucrose, nonnutritive sucking, and skin-to-skin contact) on term newborns between 24 and 48 hours of age who underwent a heel lance. The Neonatal Pain, Agitation, and Sedation Scale was used to evaluate pain. The newborns (N = 226) were assigned to one of 4 intervention groups (n = 176) or a control group without pain intervention (n = 50). The results indicate that all intervention groups showed decreased pain levels when compared with the control group (P < .01). The oral sucrose group experienced a superior analgesic effect when compared with the skin-to-skin contact group (P < .01), but no difference was observed when compared with the breastfeeding group (P > .05) or the nonnutritive sucking group (P > .05). All intervention groups showed a shortened crying time (P < .01) and reduced procedural duration (P < .01) compared with the control group. All of these interventions are clinically applicable and acceptable when caring for a newborn during a minor painful procedure.",2020,The results indicate that all intervention groups showed decreased pain levels when compared with the control group (P < .01).,"['Term Newborns Undergoing Heel Lance', 'newborns (N = 226', 'term newborns between 24 and 48 hours of age who underwent a heel lance']","['Nonpharmacologic Interventions', '4 nonpharmacologic interventions (breastfeeding, oral sucrose, nonnutritive sucking, and skin-to-skin contact', 'control group without pain intervention']","['Neonatal Pain, Agitation, and Sedation Scale', 'procedural duration', 'superior analgesic effect', 'shortened crying time', 'pain levels']","[{'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}, {'cui': 'C0522666', 'cui_str': 'Lance'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C1271035', 'cui_str': 'Provision of non-nutritive sucking'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0441636', 'cui_str': 'Surgical shortening - action'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",226.0,0.0326912,The results indicate that all intervention groups showed decreased pain levels when compared with the control group (P < .01).,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': ""Maternity Department (Mss Chang and Filoteo) and Nursing Research and Evidence-Based Practice (Dr Nasr), Stanford Children's Health, Palo Alto, California; and Department of Pediatrics, Stanford School of Medicine, Stanford, California (Dr Nasr).""}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Filoteo', 'Affiliation': ''}, {'ForeName': 'Annette S', 'Initials': 'AS', 'LastName': 'Nasr', 'Affiliation': ''}]",The Journal of perinatal & neonatal nursing,['10.1097/JPN.0000000000000495']
2272,32804892,"A Prospective, Split-Face, Comparative Study of Combined Treatment With Fractional Microneedle Radiofrequency and Nonablative 1927-nm Fractional Thulium Fiber Laser for Wrinkle Treatment.","BACKGROUND


Fractional microneedle radiofrequency (FMR) and nonablative 1927-nm fractional thulium fiber laser (TFL) are widely used for skin rejuvenation treatment.
OBJECTIVES


To investigate the efficacy and safety of combined treatment with both devices for wrinkles.
PATIENTS AND METHODS


Twenty-five patients with wrinkles were enrolled. One side of the face was treated with FMR alone, while the other side was treated with a combination of FMR and TFL. Each treatment consisted of 3 sessions at four-week intervals and patients were followed up 12 weeks after the last treatment. Overall improvement was assessed by patient global assessment (PGA) and investigator global assessment (IGA). Depression scores for the evaluation of wrinkles were objectively assessed by Antera 3D system.
RESULTS


Both sides of the face led to clinical improvement in both mean PGA and IGA. Combination treatment demonstrated a greater improvement in both mean PGA and IGA compared with FMR alone. In addition, wrinkle grading scales and depression scores showed greater improvement in the combination group than in FMR alone.
CONCLUSION


This study demonstrated that FMR and TFL comprise a good combination treatment for the treatment of wrinkles because both treatments have a synergistic effect on wrinkle improvement.",2020,"In addition, wrinkle grading scales and depression scores showed greater improvement in the combination group than in FMR alone.
",['Twenty-five patients with wrinkles were enrolled'],"['FMR and TFL', 'Fractional microneedle radiofrequency (FMR) and nonablative 1927-nm fractional thulium fiber laser (TFL', 'FMR', 'Fractional Microneedle Radiofrequency and Nonablative 1927-nm Fractional Thulium Fiber Laser']","['Depression scores', 'mean PGA and IGA', 'efficacy and safety', 'wrinkle grading scales and depression scores', 'patient global assessment (PGA) and investigator global assessment (IGA']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}]","[{'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",25.0,0.0231949,"In addition, wrinkle grading scales and depression scores showed greater improvement in the combination group than in FMR alone.
","[{'ForeName': 'Min-Young', 'Initials': 'MY', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Shinwon', 'Initials': 'S', 'LastName': 'Hwang', 'Affiliation': 'Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Soo Il', 'Initials': 'SI', 'LastName': 'Chun', 'Affiliation': 'Chunsooil Skin Clinic, Seoul, Korea.'}, {'ForeName': 'Su Min', 'Initials': 'SM', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Abdurrahman', 'Initials': 'A', 'LastName': 'Almurayshid', 'Affiliation': 'Department of Dermatology, College of Medicine, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia.'}, {'ForeName': 'Sang Ho', 'Initials': 'SH', 'LastName': 'Oh', 'Affiliation': 'Department of Dermatology, Severance Hospital, Cutaneous Biology Research Institute, Yonsei University College of Medicine, Seoul, Korea.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002672']
2273,32804911,Factors Associated with Non-Adherence in an Emergency Department Based Multicenter Randomized Clinical Trial of a Probiotic in Children with Acute Gastroenteritis.,"Non-adherence in clinical trials affects safety and efficacy determinations. Predictors of non-adherence in pediatric acute illness trials are unknown. We sought to examine predictors of non-adherence in a multicenter randomized trial of 971 children with acute gastroenteritis receiving a 5-day oral course of Lactobacillus rhamnosus GG or placebo. Adherence, defined as consuming all doses of the product, was reported by the parents and recorded during daily follow-up contacts. Of 943 patients with follow-up data, 766 (81.2%) where adherent. On multivariate analysis older age (OR 1.19; 95%CI: 1.00-1.43), increased vomiting duration (OR 1.23; 95% CI: 1.05-1.45), higher dehydration score (OR 1.23, 95% CI: 1.07-1.42) and hospitalization following ED discharge (OR 4.16, 95% CI: 1.21, 14.30) were factors associated with non-adherence; however those with highest severity scores were more likely to adhere (OR 0.87, 95% CI: 0.80-0.95). These data may inform strategies and specific targets to maximize adherence in future pediatric trials.",2020,"On multivariate analysis older age (OR 1.19; 95%CI: 1.00-1.43), increased vomiting duration (OR 1.23; 95% CI: 1.05-1.45), higher dehydration score (OR 1.23, 95% CI: 1.07-1.42) and hospitalization following ED discharge (OR 4.16, 95% CI: 1.21, 14.30) were factors associated with non-adherence; however those with highest severity scores were more likely to adhere (OR 0.87, 95% CI: 0.80-0.95).","['Children with Acute Gastroenteritis', '971 children with acute gastroenteritis receiving a 5-day oral course of', '943 patients with follow-up data, 766 (81.2%) where adherent']","['Probiotic', 'Lactobacillus rhamnosus GG or placebo']","['vomiting duration', 'hospitalization following ED discharge', 'higher dehydration score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0267446', 'cui_str': 'Acute gastroenteritis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",971.0,0.225454,"On multivariate analysis older age (OR 1.19; 95%CI: 1.00-1.43), increased vomiting duration (OR 1.23; 95% CI: 1.05-1.45), higher dehydration score (OR 1.23, 95% CI: 1.07-1.42) and hospitalization following ED discharge (OR 4.16, 95% CI: 1.21, 14.30) were factors associated with non-adherence; however those with highest severity scores were more likely to adhere (OR 0.87, 95% CI: 0.80-0.95).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schnadower', 'Affiliation': 'Department of Emergency Medicine, Columbia University College of Physicians & Surgeons, New York, NY, USA.'}, {'ForeName': 'Cindy G', 'Initials': 'CG', 'LastName': 'Roskind', 'Affiliation': 'Department of Emergency Medicine, Columbia University College of Physicians & Surgeons, New York, NY, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'VanBuren', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Powell', 'Affiliation': ""Division of Emergency Medicine, Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.""}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Norris', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Phillip I', 'Initials': 'PI', 'LastName': 'Tarr', 'Affiliation': 'Division of Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, Washington University in St. Louis School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Sapien', 'Affiliation': 'Department of Emergency Medicine, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': ""O'Connell"", 'Affiliation': ""Division of Emergency Medicine, Children's National Health System, Department of Pediatrics, The George Washington School of Medicine and Health Sciences, Washington, DC, USA.""}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Chun', 'Affiliation': ""Department of Emergency Medicine, Rhode Island Hospital/Hasbro Children's Hospital and Brown University, Providence, RI, USA.""}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Rogers', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Seema R', 'Initials': 'SR', 'LastName': 'Bhatt', 'Affiliation': ""Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.""}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Mahajan', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Marc H', 'Initials': 'MH', 'LastName': 'Gorelick', 'Affiliation': ""Central Administration, Children's Minnesota, Minneapolis MN, USA.""}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Vance', 'Affiliation': 'Departments of Emergency Medicine and Pediatrics, University of California, Davis, School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Dean', 'Affiliation': 'Department of Pediatrics, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Freedman', 'Affiliation': ""Sections of Pediatric Emergency Medicine and Gastroenterology, Department of Pediatrics, Alberta Children's Hospital, Alberta Children's Hospital Research Institute, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.""}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002904']
2274,32805050,Processing Apples to Puree or Juice Speeds Gastric Emptying and Reduces Postprandial Intestinal Volumes and Satiety in Healthy Adults.,"BACKGROUND


Whole apples produce greater satiety than processed apples, but the underlying mechanisms remain unclear.
OBJECTIVE


Our aim was to assess the intragastric processing of apple preparations and the associated small and large bowel contents using MRI.
METHODS


An open label, 3-way crossover, randomized, controlled trial. Eighteen healthy adults (mean ± SD age, 25 ± 4 y; BMI, 22.7 ± 3.5 kg/m2) underwent serial MRI scans on 3 occasions separated by 7 d, after consumption of isocaloric (178 kcal) portions of either whole apples, apple puree, or apple juice. Gastric emptying, small bowel water content (SBWC; primary endpoint), were measured at baseline and at 45 min intervals (0-270 min) postmeal ingestion. Fullness and satiety were also assessed at each time point. Treatment effects between groups were analyzed using ANOVA.
RESULTS


Gastric emptying half-time (GE t50) was greater (P < 0.0001) after participants consumed whole apple (mean ± SEM), 65 (3.3) min compared with when they consumed apple puree (41 [2.8] min) or apple juice (38 [2.9] min), times that did not differ. Postprandial area under the curve (AUC) (135-270 min) SBWC was also greater for whole apples than puree (P = 0.025) and juice (P = 0.0004) but juice and puree did not differ. AUC for fullness and satiety (0-270 min) postingestion was also greater (P = 0.002 and 0.004, respectively) for whole apple compared with juice but juice and puree did not differ.
CONCLUSIONS


Gastric emptying is slower after whole apple consumption causing a greater sensation of fullness and satiety than puree or juice in healthy adults. Whole apples increased small bowel and colonic contents during the later phase of the study which may be relevant for subsequent food consumption.This study was registered at clinicaltrials.gov as NCT03714464.",2020,SBWC was also greater for whole apples than puree (P = 0.025) and juice (P = 0.0004) but juice and puree did not differ.,"['Eighteen healthy adults (mean\xa0±\xa0SD age, 25\xa0±\xa04\xa0y; BMI, 22.7\xa0±\xa03.5 kg/m2) underwent', 'Healthy Adults', 'healthy adults']","['MRI', 'serial MRI scans on 3 occasions separated by 7 d, after consumption of isocaloric (178 kcal) portions of either whole apples, apple puree, or apple juice']","['Postprandial Intestinal Volumes and Satiety', 'Gastric emptying half-time (GE t50', 'Postprandial area under the curve (AUC', 'SBWC', 'Gastric emptying, small bowel water content (SBWC', 'sensation of fullness and satiety', 'fullness and satiety', 'small bowel and colonic contents', 'Fullness and satiety']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0003625', 'cui_str': 'Malus'}, {'cui': 'C0452454', 'cui_str': 'Apple juice'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0017127', 'cui_str': 'Gastric emptying'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}, {'cui': 'C0227363', 'cui_str': 'Colonic contents'}]",18.0,0.164656,SBWC was also greater for whole apples than puree (P = 0.025) and juice (P = 0.0004) but juice and puree did not differ.,"[{'ForeName': 'Shanthi', 'Initials': 'S', 'LastName': 'Krishnasamy', 'Affiliation': 'Faculty of Health Sciences, Universiti Kebangsaan Malaysia (UKM), Kuala Lumpur, Malaysia.'}, {'ForeName': 'Miranda Clare Elizabeth', 'Initials': 'MCE', 'LastName': 'Lomer', 'Affiliation': ""Department of Nutritional Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Marciani', 'Affiliation': 'National Institute of Health Research, Nottingham Biomedical Research Centre (BRC) at Nottingham University Hospitals National Health Service Trust and University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Caroline Louise', 'Initials': 'CL', 'LastName': 'Hoad', 'Affiliation': 'National Institute of Health Research, Nottingham Biomedical Research Centre (BRC) at Nottingham University Hospitals National Health Service Trust and University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Susan Elizabeth', 'Initials': 'SE', 'LastName': 'Pritchard', 'Affiliation': 'Sir Peter Mansfield Imaging Centre, School of Physics and Astronomy, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Paul', 'Affiliation': 'Sir Peter Mansfield Imaging Centre, School of Physics and Astronomy, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Penny Ann', 'Initials': 'PA', 'LastName': 'Gowland', 'Affiliation': 'Sir Peter Mansfield Imaging Centre, School of Physics and Astronomy, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Robin Charles', 'Initials': 'RC', 'LastName': 'Spiller', 'Affiliation': 'National Institute of Health Research, Nottingham Biomedical Research Centre (BRC) at Nottingham University Hospitals National Health Service Trust and University of Nottingham, Nottingham, United Kingdom.'}]",The Journal of nutrition,['10.1093/jn/nxaa191']
2275,32805081,Prognostic value of POD24 validation in follicular lymphoma patients initially treated with chemotherapy-free regimens in a pooled analysis of three randomized trials of the Swiss Group for Clinical Cancer Research (SAKK).,"The relapse of follicular lymphoma (FL) within 24 months (POD24) of chemoimmunotherapy has been associated with poor survival. We analyzed a pooled dataset of three randomized trials including FL patients with advanced disease, conducted by the Swiss Group for Clinical Cancer Research (SAKK). Overall, POD24 was observed in 27% of 318 patients, but rate variance among studies suggested that the rituximab schedule might affect POD24 rate. POD24 was associated with lower 10-year overall survival rates than in the reference group (69% vs. 77%; hazard ratio, 3·12; 95% confidence interval, 1·73-5·65). POD24 retains its prognostic validity in patients treated without chemotherapy and may represent a useful end-point for future studies.",2020,"POD24 was associated with lower 10-year overall survival rates than in the reference group (69% vs. 77%; hazard ratio, 3·12; 95% confidence interval, 1·73-5·65).","['follicular lymphoma patients initially treated with chemotherapy-free regimens in a pooled analysis of three randomized trials of the Swiss Group for Clinical Cancer Research (SAKK', 'FL patients with advanced disease, conducted by the Swiss Group for Clinical Cancer Research (SAKK']",['chemoimmunotherapy'],"['POD24', 'POD24 rate', 'relapse of follicular lymphoma (FL', '10-year overall survival rates']","[{'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0241315', 'cui_str': 'Swiss'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",[],"[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",318.0,0.229582,"POD24 was associated with lower 10-year overall survival rates than in the reference group (69% vs. 77%; hazard ratio, 3·12; 95% confidence interval, 1·73-5·65).","[{'ForeName': 'Alden Alberto', 'Initials': 'AA', 'LastName': 'Moccia', 'Affiliation': 'Clinic of Medical Oncology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}, {'ForeName': 'Sämi', 'Initials': 'S', 'LastName': 'Schär', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hayoz', 'Affiliation': 'SAKK Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Pirosa', 'Affiliation': 'Clinic of Medical Oncology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Taverna', 'Affiliation': 'Division of Medical Oncology, Kantonsspital Münsterlingen, Münsterlingen, Switzerland.'}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Novak', 'Affiliation': 'Department of Medical Oncology, Inselspita/Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kimby', 'Affiliation': 'Unit of Hematology, Department of Medicine at Huddinge, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Ghielmini', 'Affiliation': 'Clinic of Medical Oncology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Zucca', 'Affiliation': 'Clinic of Medical Oncology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}]",British journal of haematology,['10.1111/bjh.17045']
2276,32805133,Three-Year Outcomes of Bariatric Surgery in Patients With Obesity and Hypertension : A Randomized Clinical Trial.,"BACKGROUND


Midterm effects of bariatric surgery on patients with obesity and hypertension remain uncertain.
OBJECTIVE


To determine the 3-year effects of Roux-en-Y gastric bypass (RYGB) on blood pressure (BP) compared with medical therapy (MT) alone.
DESIGN


Randomized clinical trial. (ClinicalTrials.gov: NCT01784848).
SETTING


Investigator-initiated study at Heart Hospital (HCor), São Paulo, Brazil.
PARTICIPANTS


Patients with hypertension receiving at least 2 medications at maximum doses or more than 2 medications at moderate doses and with a body mass index (BMI) between 30.0 and 39.9 kg/m 2  were randomly assigned (1:1 ratio).
INTERVENTION


RYGB plus MT or MT alone.
MEASUREMENTS


The primary outcome was at least a 30% reduction in total number of antihypertensive medications while maintaining BP less than 140/90 mm Hg. Key secondary outcomes were number of antihypertensive medications, hypertension remission, and BP control according to current guidelines (<130/80 mm Hg).
RESULTS


Among 100 patients (76% female; mean BMI, 36.9 kg/m 2  [SD, 2.7]), 88% from the RYGB group and 80% from the MT group completed follow-up. At 3 years, the primary outcome occurred in 73% of patients from the RYGB group compared with 11% of patients from the MT group (relative risk, 6.52 [95% CI, 2.50 to 17.03];  P <  0.001). Of the randomly assigned participants, 35% and 31% from the RYGB group and 2% and 0% from the MT group achieved BP less than 140/90 mm Hg and less than 130/80 mm Hg without medications, respectively. Median (interquartile range) number of medications in the RYGB and MT groups at 3 years was 1 (0 to 2) and 3 (2.8 to 4), respectively ( P <  0.001). Total weight loss was 27.8% and -0.1% in the RYGB and MT groups, respectively. In the RYGB group, 13 patients developed hypovitaminosis B 12  and 2 patients required reoperation.
LIMITATION


Single-center, nonblinded trial.
CONCLUSION


RYGB is an effective strategy for midterm BP control and hypertension remission, with fewer medications required in patients with hypertension and obesity.
PRIMARY FUNDING SOURCE


Ethicon, represented in Brazil by Johnson & Johnson do Brasil.",2020,"Total weight loss was 27.8% and -0.1% in the RYGB and MT groups, respectively.","['100 patients (76% female; mean BMI, 36.9 kg/m 2  [SD, 2.7]), 88% from the RYGB group and 80% from the MT group completed follow-up', 'patients with obesity and hypertension remain uncertain', 'Investigator-initiated study at Heart Hospital (HCor), São Paulo, Brazil', 'Patients With Obesity and Hypertension', 'patients with hypertension and obesity', 'Patients with hypertension receiving at least 2 medications at maximum doses or more than 2 medications at moderate doses and with a body mass index (BMI) between 30.0 and 39.9 kg/m 2']","['Bariatric Surgery', 'Roux-en-Y gastric bypass (RYGB', 'bariatric surgery', 'RYGB', 'RYGB plus MT or MT alone', 'medical therapy (MT) alone']","['Total weight loss', 'Median (interquartile range) number of medications', 'number of antihypertensive medications, hypertension remission, and BP control according to current guidelines', 'blood pressure (BP', 'total number of antihypertensive medications while maintaining BP less', 'BP less', 'reoperation']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}]",100.0,0.207437,"Total weight loss was 27.8% and -0.1% in the RYGB and MT groups, respectively.","[{'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Schiavon', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil (C.A.S., E.V.S., R.N.S., L.P.D., J.D.O., R.H.M., A.B.C.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, Massachusetts (D.L.B.).""}, {'ForeName': 'Dimas', 'Initials': 'D', 'LastName': 'Ikeoka', 'Affiliation': 'HCor Intensive Unit, São Paulo, Brazil (D.I.).'}, {'ForeName': 'Eliana V', 'Initials': 'EV', 'LastName': 'Santucci', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil (C.A.S., E.V.S., R.N.S., L.P.D., J.D.O., R.H.M., A.B.C.).'}, {'ForeName': 'Renato Nakagawa', 'Initials': 'RN', 'LastName': 'Santos', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil (C.A.S., E.V.S., R.N.S., L.P.D., J.D.O., R.H.M., A.B.C.).'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Damiani', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil (C.A.S., E.V.S., R.N.S., L.P.D., J.D.O., R.H.M., A.B.C.).'}, {'ForeName': 'Juliana D', 'Initials': 'JD', 'LastName': 'Oliveira', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil (C.A.S., E.V.S., R.N.S., L.P.D., J.D.O., R.H.M., A.B.C.).'}, {'ForeName': 'Rachel Helena V', 'Initials': 'RHV', 'LastName': 'Machado', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil (C.A.S., E.V.S., R.N.S., L.P.D., J.D.O., R.H.M., A.B.C.).'}, {'ForeName': 'Helio', 'Initials': 'H', 'LastName': 'Halpern', 'Affiliation': 'HCor Surgical Center, São Paulo, Brazil (H.H., F.L.M., P.M.N.).'}, {'ForeName': 'Frederico L J', 'Initials': 'FLJ', 'LastName': 'Monteiro', 'Affiliation': 'HCor Surgical Center, São Paulo, Brazil (H.H., F.L.M., P.M.N.).'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Noujaim', 'Affiliation': 'HCor Surgical Center, São Paulo, Brazil (H.H., F.L.M., P.M.N.).'}, {'ForeName': 'Ricardo V', 'Initials': 'RV', 'LastName': 'Cohen', 'Affiliation': 'Oswaldo Cruz German Hospital, São Paulo, Brazil (R.V.C.).'}, {'ForeName': 'Marcio G', 'Initials': 'MG', 'LastName': 'de Souza', 'Affiliation': 'Dante Pazzanese Institute of Cardiology, São Paulo, Brazil (M.G.D.).'}, {'ForeName': 'Celso', 'Initials': 'C', 'LastName': 'Amodeo', 'Affiliation': 'Federal University of São Paulo, São Paulo, Brazil (C.A.).'}, {'ForeName': 'Luiz A', 'Initials': 'LA', 'LastName': 'Bortolotto', 'Affiliation': 'Hypertension Unit, Heart Institute (In-Cor), University of São Paulo Medical School, São Paulo, Brazil (L.A.B.).'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Berwanger', 'Affiliation': 'Albert Einstein Hospital, São Paulo, Brazil (O.B.).'}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'HCor Research Institute, São Paulo, Brazil (C.A.S., E.V.S., R.N.S., L.P.D., J.D.O., R.H.M., A.B.C.).'}, {'ForeName': 'Luciano F', 'Initials': 'LF', 'LastName': 'Drager', 'Affiliation': 'University of São Paulo Medical School, São Paulo, Brazil (L.F.D.).'}]",Annals of internal medicine,['10.7326/M19-3781']
2277,32805150,Action Observation Treatment in a tele-rehabilitation setting: a pilot study in children with cerebral palsy.,"OBJECTIVE


Action Observation Treatment is a novel rehabilitation approach exploiting a neurophysiological mechanism that allows one to recruit the neural structures sub-serving action execution during the mere observation of those same actions. Action Observation Treatment is effective in the rehabilitation of several neurological diseases. In this pilot study, we used Action Observation Treatment in a telerehabilitation setting in children with Cerebral Palsy.
MATERIALS AND METHODS


Ten children with Cerebral Palsy, aged 5-12 years, entered the study. They followed the Action Observation Treatment rehabilitation program at home with remote supervision by a child neurologist located at the hospital. Outcome measures were the scores at the Melbourne Assessment of Unilateral Upper Limb Function Scale and the Assisting Hand Assessment.
RESULTS


Scores obtained after treatment and at a two months' follow-up significantly differed from baseline and overlapped those obtained in randomized controlled studies carried out in a conventional setting.
CONCLUSIONS


Action Observation Treatment is therefore a promising approach that can be used on a large scale in a telerehabilitation setting. IMPLICATIONS FOR REHABILITATION Tele-rehabilitation has the potential to enhance early intervention service provision for children with Cerebral Palsy. Action Observation Treatment has the potential to become a routine approach in a telerehabilitation setting.",2020,"RESULTS


Scores obtained after treatment and at a two months' follow-up significantly differed from baseline and overlapped those obtained in randomized controlled studies carried out in a conventional setting.
","['Ten children with Cerebral Palsy, aged 5-12\xa0years, entered the study', 'children with cerebral palsy', 'children with Cerebral Palsy']",[],['scores at the Melbourne Assessment of Unilateral Upper Limb Function Scale and the Assisting Hand Assessment'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2732438', 'cui_str': 'Melbourne assessment of unilateral upper limb function'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",10.0,0.0154812,"RESULTS


Scores obtained after treatment and at a two months' follow-up significantly differed from baseline and overlapped those obtained in randomized controlled studies carried out in a conventional setting.
","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Molinaro', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Micheletti', 'Affiliation': 'Unit of Child Neurology and Psychiatry, ASST Civil Hospital, Brescia, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Pagani', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Gioacchino', 'Initials': 'G', 'LastName': 'Garofalo', 'Affiliation': 'Department of Humanities, Social Sciences and Cultural Industries, University of Parma, Parma, Italy.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Galli', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Rossi', 'Affiliation': 'Unit of Child Neurology and Psychiatry, ASST Civil Hospital, Brescia, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Fazzi', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Buccino', 'Affiliation': 'Division of Neuroscience, IRCCS San Raffaele and University San Raffaele, Milan, Italy.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1793009']
2278,32805184,Effects of Fatty Acid Therapy in Addition to Strong Statin on Coronary Plaques in Acute Coronary Syndrome: An Optical Coherence Tomography Study.,"BACKGROUND Vascular healing response associated with adjunctive n-3 polyunsaturated fatty acid therapy therapy in patients receiving strong statin therapy remains unclear. The aim of this study was to evaluate the effect of polyunsaturated fatty acid therapy with eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA) in addition to strong statin therapy on coronary atherosclerotic plaques using optical coherence tomography. METHODS AND RESULTS This prospective multicenter randomized controlled trial included 130 patients with acute coronary syndrome treated with strong statins. They were assigned to either statin only (control group, n=42), statin+high-dose EPA (1800 mg/day) (EPA group, n=40), statin+EPA (930 mg/day)+DHA (750 mg/day) (EPA+DHA group, n=48). Optical coherence tomography was performed at baseline and at the 8-month follow-up. The target for optical coherence tomography analysis was a nonculprit lesion with a lipid plaque. Between baseline and the 8-month follow-up, fibrous cap thickness (FCT) significantly increased in all 3 groups. There were no significant differences in the percent change for minimum FCT between the EPA or EPA+DHA group and the control group. In patients with FCT <120 µm (median value), the percent change for minimum FCT was significantly higher in the EPA or EPA+DHA group compared with the control group. CONCLUSIONS EPA or EPA+DHA therapy in addition to strong statin therapy did not significantly increase FCT in nonculprit plaques compared with strong statin therapy alone, but significantly increased FCT in patients with thinner FCT. Registration URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN 000012825.",2020,"Between baseline and the 8-month follow-up, fibrous cap thickness (FCT) significantly increased in all 3 groups.","['patients with thinner FCT', 'Acute Coronary Syndrome', '130 patients with acute coronary syndrome treated with strong statins', 'patients receiving strong statin therapy remains unclear']","['Fatty Acid Therapy', 'polyunsaturated fatty acid therapy with eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA', 'statin+EPA (930\xa0mg/day)+DHA', 'adjunctive n-3 polyunsaturated fatty acid therapy therapy', 'statin+high-dose EPA', 'statin']","['coronary atherosclerotic plaques', 'fibrous cap thickness (FCT', 'FCT', 'minimum FCT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C2936350', 'cui_str': 'Atherosclerotic Plaques'}, {'cui': 'C0439709', 'cui_str': 'Fibrous'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",130.0,0.076865,"Between baseline and the 8-month follow-up, fibrous cap thickness (FCT) significantly increased in all 3 groups.","[{'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Kita', 'Affiliation': 'Department of Cardiovascular Medicine Nara Medical University Kashihara Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Cardiovascular Medicine Nara Medical University Kashihara Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Kamon', 'Affiliation': 'Department of Cardiovascular Medicine Nara Medical University Kashihara Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'Department of Cardiovascular Medicine Nara Medical University Kashihara Japan.'}, {'ForeName': 'Tsunenari', 'Initials': 'T', 'LastName': 'Soeda', 'Affiliation': 'Department of Cardiovascular Medicine Nara Medical University Kashihara Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Okayama', 'Affiliation': 'Department of Cardiovascular Medicine Nara Medical University Kashihara Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Ishigami', 'Affiliation': 'Department of Cardiology Saiseikai Suita Hospital Suita Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kawata', 'Affiliation': 'Department of Cardiovascular Medicine Nara Prefecture General Medical Center Nara Japan.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Horii', 'Affiliation': 'Department of Cardiovascular Medicine Nara City Hospital Nara Japan.'}, {'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Inoue', 'Affiliation': 'Yamato Kashihara Hospital Kashihara Japan.'}, {'ForeName': 'Naofumi', 'Initials': 'N', 'LastName': 'Doi', 'Affiliation': 'Department of Cardiology Nara Prefecture Seiwa Medical Center Nara Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okura', 'Affiliation': 'Department of Cardiology Gifu University Gradual School of Medicine Gifu Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Uemura', 'Affiliation': 'Division of CardiologyKawasaki Medical School Kurashiki Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Department of Cardiovascular Medicine Nara Medical University Kashihara Japan.'}]",Journal of the American Heart Association,['10.1161/JAHA.119.015593']
2279,32805185,Effect of Luseogliflozin on Heart Failure With Preserved Ejection Fraction in Patients With Diabetes Mellitus.,"Background Effects of sodium-glucose cotransporter 2 inhibitors on reducing hospitalization for heart failure have been reported in randomized controlled trials, but their effects on patients with heart failure with preserved ejection fraction (HFpEF) are unknown. This study aimed to evaluate the drug efficacy of luseogliflozin, a sodium-glucose cotransporter 2 inhibitor, in patients with type 2 diabetes mellitus and HFpEF. Methods and Results We performed a multicenter, open-label, randomized, controlled trial for comparing luseogliflozin 2.5 mg once daily with voglibose 0.2 mg 3 times daily in patients with type 2 diabetes mellitus suffering from HFpEF (left ventricular ejection fraction >45% and BNP [B-type natriuretic peptide] concentrations ≥35 pg/mL) in a 1:1 randomization fashion. The primary outcome was the difference from baseline in BNP levels after 12 weeks of treatment between the 2 drugs. A total of 173 patients with diabetes mellitus and HFpEF were included. Of these, 83 patients were assigned to receive luseogliflozin and 82 to receive voglibose. There was no significant difference in the reduction in BNP concentrations after 12 weeks from baseline between the 2 groups. The ratio of the mean BNP value at week 12 to the baseline value was 0.79 in the luseogliflozin group and 0.87 in the voglibose group (percent change, -9.0% versus -1.9%; ratio of change with luseogliflozin versus voglibose, 0.93; 95% CI, 0.78-1.10;  P =0.26). Conclusion In patients with type 2 diabetes mellitus and HFpEF, there is no significant difference in the degree of reduction in BNP concentrations after 12 weeks between luseogliflozin and voglibose. Registration URL: https://www.umin.ac.jp/ctr/index.htm; Unique identifier: UMIN000018395.",2020,"The ratio of the mean BNP value at week 12 to the baseline value was 0.79 in the luseogliflozin group and 0.87 in the voglibose group (percent change, -9.0% versus -1.9%; ratio of change with luseogliflozin versus voglibose, 0.93; 95% CI, 0.78-1.10;  P =0.26).","['patients with heart failure with preserved ejection fraction (HFpEF', 'patients with type 2 diabetes mellitus suffering from HFpEF', '83 patients', 'Patients With Diabetes Mellitus', 'patients with type 2 diabetes mellitus and HFpEF', '173 patients with diabetes mellitus and HFpEF were included']","['Luseogliflozin', 'sodium-glucose cotransporter 2 inhibitors', 'luseogliflozin', 'luseogliflozin and 82 to receive voglibose', 'luseogliflozin, a sodium-glucose cotransporter 2 inhibitor', 'BNP [B-type natriuretic peptide', 'luseogliflozin 2.5\xa0mg once daily with voglibose 0.2\xa0mg 3 times daily']","['Heart Failure With Preserved Ejection Fraction', 'ratio of the mean BNP value', 'BNP concentrations', 'BNP levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2933904', 'cui_str': '1,5-anhydro-1-(5-(4-ethoxybenzyl)-2-methoxy-4-methylphenyl)-1-thioglucitol'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0532578', 'cui_str': 'voglibose'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}]","[{'cui': 'C2960127', 'cui_str': 'Heart failure with normal ejection fraction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",173.0,0.100141,"The ratio of the mean BNP value at week 12 to the baseline value was 0.79 in the luseogliflozin group and 0.87 in the voglibose group (percent change, -9.0% versus -1.9%; ratio of change with luseogliflozin versus voglibose, 0.93; 95% CI, 0.78-1.10;  P =0.26).","[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ejiri', 'Affiliation': 'Department of Cardiovascular Medicine Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences Okayama Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Internal Medicine Tamano City Hospital Okayama Japan.'}, {'ForeName': 'Hajime', 'Initials': 'H', 'LastName': 'Kihara', 'Affiliation': 'Department of Internal Medicine Kihara Cardiovascular Clinic Asahikawa Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Hata', 'Affiliation': 'Department of Cardiology Minamino Cardiovascular Hospital Hachioji Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Nagano', 'Affiliation': 'Department of Internal Medicine Iwasa Hospital Gifu Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Takaishi', 'Affiliation': 'Department of Cardiology Mitoyo General Hospital Kanonji Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Toda', 'Affiliation': 'Department of Cardiovascular Medicine Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences Okayama Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Nanba', 'Affiliation': 'Department of Cardiology Okayama Rosai Hospital Okayama Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Department of Cardiovascular Medicine Specified Clinic of Soyokaze Cardiovascular Medicine and Diabetes Care Matsuyama Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Akagi', 'Affiliation': 'Department of Cardiovascular Medicine Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences Okayama Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Sakuragi', 'Affiliation': 'Department of Cardiovascular Medicine Iwakuni Clinical Center Iwakuni Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Minagawa', 'Affiliation': 'Department of Internal Medicine Minagawa Cardiovascular Clinic Gifu Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kawai', 'Affiliation': 'Department of Cardiovascular Medicine Okayama City Hospital Okayama Japan.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Nishii', 'Affiliation': 'Department of Cardiovascular Medicine Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences Okayama Japan.'}, {'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Fuke', 'Affiliation': 'Department of Cardiovascular Medicine Japanese Red Cross Okayama Hospital Okayama Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Yoshikawa', 'Affiliation': 'Department of Cardiology Fukuyama City Hospital Fukuyama Japan.'}, {'ForeName': 'Kazufumi', 'Initials': 'K', 'LastName': 'Nakamura', 'Affiliation': 'Department of Cardiovascular Medicine Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences Okayama Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Cardiovascular Medicine Okayama University Graduate School of Medicine, Density and Pharmaceutical Sciences Okayama Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Heart Association,['10.1161/JAHA.119.015103']
2280,32799967,"Validation and calibration of the Eating Assessment in Toddlers FFQ (EAT FFQ) for children, used in the Growing Up Milk - Lite (GUMLi) randomised controlled trial.","The Eating Assessment in Toddlers FFQ (EAT FFQ) has been shown to have good reliability and comparative validity for ranking nutrient intakes in young children. With the addition of food items (n 4), we aimed to re-assess the validity of the EAT FFQ and estimate calibration factors in a sub-sample of children (n 97) participating in the Growing Up Milk - Lite (GUMLi) randomised control trial (2015-2017). Participants completed the ninety-nine-item GUMLi EAT FFQ and record-assisted 24-h recalls (24HR) on two occasions. Energy and nutrient intakes were assessed at months 9 and 12 post-randomisation and calibration factors calculated to determine predicted estimates from the GUMLi EAT FFQ. Validity was assessed using Pearson correlation coefficients, weighted kappa (κ) and exact quartile categorisation. Calibration was calculated using linear regression models on 24HR, adjusted for sex and treatment group. Nutrient intakes were significantly correlated between the GUMLi EAT FFQ and 24HR at both time points. Energy-adjusted, de-attenuated Pearson correlations ranged from 0·3 (fibre) to 0·8 (Fe) at 9 months and from 0·3 (Ca) to 0·7 (Fe) at 12 months. Weighted κ for the quartiles ranged from 0·2 (Zn) to 0·6 (Fe) at 9 months and from 0·1 (total fat) to 0·5 (Fe) at 12 months. Exact agreement ranged from 30 to 74 %. Calibration factors predicted up to 56 % of the variation in the 24HR at 9 months and 44 % at 12 months. The GUMLi EAT FFQ remained a useful tool for ranking nutrient intakes with similar estimated validity compared with other FFQ used in children under 2 years.",2020,The GUMLi EAT FFQ remained a useful tool for ranking nutrient intakes with similar estimated validity compared with other FFQ used in children under 2 years.,"['Toddlers FFQ (EAT FFQ) for children', 'young children', 'sub-sample of children (n 97) participating in the Growing Up Milk - Lite (GUMLi) randomised control trial (2015-2017', 'Toddlers FFQ (EAT FFQ']",[],"['Energy and nutrient intakes', 'Nutrient intakes']","[{'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0006777', 'cui_str': 'Energy intake'}]",,0.0654151,The GUMLi EAT FFQ remained a useful tool for ranking nutrient intakes with similar estimated validity compared with other FFQ used in children under 2 years.,"[{'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Lovell', 'Affiliation': 'Discipline of Nutrition and Dietetics, Faculty of Medical and Health Sciences, University of Auckland, Auckland, 1023, New Zealand.'}, {'ForeName': 'Peter S W', 'Initials': 'PSW', 'LastName': 'Davies', 'Affiliation': ""Children's Nutrition Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, 4101, Australia.""}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Hill', 'Affiliation': ""Children's Nutrition Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, 4101, Australia.""}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Milne', 'Affiliation': 'Discipline of Nutrition and Dietetics, Faculty of Medical and Health Sciences, University of Auckland, Auckland, 1023, New Zealand.'}, {'ForeName': 'Misa', 'Initials': 'M', 'LastName': 'Matsuyama', 'Affiliation': ""Children's Nutrition Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, 4101, Australia.""}, {'ForeName': 'Yannan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Statistics, Faculty of Science, University of Auckland, Auckland, 1010, New Zealand.'}, {'ForeName': 'Rachel X', 'Initials': 'RX', 'LastName': 'Chen', 'Affiliation': 'Department of Statistics, Faculty of Science, University of Auckland, Auckland, 1010, New Zealand.'}, {'ForeName': 'Anne-Louise M', 'Initials': 'AM', 'LastName': 'Heath', 'Affiliation': 'Department of Human Nutrition, University of Otago, Dunedin, 9016, New Zealand.'}, {'ForeName': 'Cameron C', 'Initials': 'CC', 'LastName': 'Grant', 'Affiliation': 'Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, 1023, New Zealand.'}, {'ForeName': 'Clare R', 'Initials': 'CR', 'LastName': 'Wall', 'Affiliation': 'Discipline of Nutrition and Dietetics, Faculty of Medical and Health Sciences, University of Auckland, Auckland, 1023, New Zealand.'}]",The British journal of nutrition,['10.1017/S0007114520002664']
2281,32799970,Mindfulness-based Wellness and Resilience intervention among interdisciplinary primary care teams: a mixed-methods feasibility and acceptability trial.,"AIMS


The primary objective of this study was to evaluate feasibility and acceptability of Mindfulness-based Wellness and Resilience (MBWR): a brief mindfulness-based intervention designed to enhance resilience and is delivered to interdisciplinary primary care teams.
BACKGROUND


Burnout is a pervasive, international problem affecting the healthcare workforce, characterized by emotional exhaustion, depersonalization, and decreased professional effectiveness. Delivery models of mindfulness-based resilience interventions that enhance feasibility for onsite delivery, consider cultural considerations specific to primary care, and utilize team processes that are integral to primary care are now needed.
METHODS


We conducted a mixed-methods feasibility and acceptability trial of MBWR. Primary feasibility and acceptability outcomes were assessed by number of participants recruited, percent of MBWR treatment completer, and attrition rate during the 8-week intervention, and four items on a Likert-type scale. Secondary outcomes of perceived effects were measured by focus groups, an online survey, and self-reported questionnaires, including the Brief Resilience Scale, the Five Facet Mindfulness Questionnaire-Short Form, and the Self-Compassion Scale-Short Form. Participants included 31 healthcare providers on interdisciplinary primary care teams employed a safety-net medical center. In the MBWR group, 68% identified as Latinx, compared to 64% in the control group.
FINDINGS


All criteria for feasibility were met and participants endorsed high levels of satisfaction and acceptability. The results of this study suggest that MBWR provides multiple perceived benefits to the individual healthcare provider, cohesion of the healthcare team, and enhanced patient care. MBWR may be a feasible and acceptable method to integrate mindfulness, resilience, and teamwork training into the primary care setting.",2019,"In the MBWR group, 68% identified as Latinx, compared to 64% in the control group.
",['Participants included 31 healthcare providers on interdisciplinary primary care teams employed a safety-net medical center'],"['MBWR', 'Mindfulness-based Wellness and Resilience intervention', 'Mindfulness-based Wellness and Resilience (MBWR']","['online survey, and self-reported questionnaires, including the Brief Resilience Scale, the Five Facet Mindfulness Questionnaire-Short Form, and the Self-Compassion Scale-Short Form', 'attrition rate']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}]",31.0,0.041211,"In the MBWR group, 68% identified as Latinx, compared to 64% in the control group.
","[{'ForeName': 'Dana Dharmakaya', 'Initials': 'DD', 'LastName': 'Colgan', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Christopher', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bowen', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Brems', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Hunsinger', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Tucker', 'Affiliation': 'Virginia Garcia Memorial Health Center, Primary Care, Hillsboro, OR, USA.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Dapolonia', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, USA.'}]",Primary health care research & development,['10.1017/S1463423619000173']
2282,32800005,'We got more than we expected.'  Older people's experiences of falls-prevention exercise interventions and implications for practice; a qualitative study.,"AIM


To explore the experiences of older adults participating in strength and balance exercise programmes and understand participants' rationale for programme uptake and completion.
BACKGROUND


Regular physical activity, specifically strength and balance exercises, has been shown to improve health and well-being and reduce the risk of falling in older adults. With the number of people living into older age increasing, understanding older people's experiences of strength and balance programmes and what encourages their take-up and completion is extremely important. This paper reports on the qualitative experiences of older adults that previously participated in ProAct65+, a randomised controlled trial of Falls Management Exercise (FaME) programme and Otago Exercise Programme (OEP) versus usual care.
METHODS


Ten general practices in Nottinghamshire and Derbyshire, England, who participated in the ProAct65+ trial were approached to take part. Using maximum variation sampling (age, gender, falls history, fear of falling and trial arm) we recruited, via the practices, 30 people that had participated in the FaME (n = 15) or OEP (n = 15) trial arms. Participants were interviewed in their own homes. Interviews were audio-recorded, transcribed verbatim and thematically analysed.
FINDINGS


We identified five themes: choice of exercise programme; commitment, discipline and motivation; benchmarking, feedback and monitoring; benefits of the exercise programmes and reactions to the end of the programmes. There were four sub-themes within the benefits theme: pleasure and boredom, social interaction and isolation, physical benefits, and knowledge and understanding.This study has outlined the experiences and identified specific barriers and facilitators to uptake and completion of falls-prevention exercises by older adults. The perspective and experiences of these participants is important if programmes are to be designed to meet the needs of the target population. Insights from this study will enable commissioners to develop and provide appropriate falls-prevention exercise programmes that encourage high uptake and programme completion.",2019,"With the number of people living into older age increasing, understanding older people's experiences of strength and balance programmes and what encourages their take-up and completion is extremely important.","[""Older people's experiences of falls"", 'older adults', '30 people that had participated in the FaME (n = 15) or OEP (n = 15) trial arms', 'Ten general practices in Nottinghamshire and Derbyshire, England, who participated in the ProAct65+ trial were approached to take part', 'older adults that previously participated in ProAct65', 'older adults participating in', 'Participants were interviewed in their own homes']","['Falls Management Exercise (FaME) programme and Otago Exercise Programme (OEP) versus usual care', 'prevention exercise interventions', 'strength and balance exercise programmes']","['pleasure and boredom, social interaction and isolation, physical benefits, and knowledge and understanding']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0454870', 'cui_str': 'Nottinghamshire'}, {'cui': 'C0454848', 'cui_str': 'Derbyshire'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0006019', 'cui_str': 'Boredom'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",10.0,0.0486069,"With the number of people living into older age increasing, understanding older people's experiences of strength and balance programmes and what encourages their take-up and completion is extremely important.","[{'ForeName': 'Natasher', 'Initials': 'N', 'LastName': 'Lafond', 'Affiliation': 'Research Fellow, University of Nottingham, School of Medicine, United Kingdom.'}, {'ForeName': 'Asiya', 'Initials': 'A', 'LastName': 'Maula', 'Affiliation': 'ACF GPR, University of Nottingham, School of Medicine, United Kingdom.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Iliffe', 'Affiliation': 'Professor of Primary Care for Older People (Now Emeritus Professor), University College London, Research Department of Primary Care & Population Health, United Kingdom.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Vedhara', 'Affiliation': 'Professor of Health Psychology, University of Nottingham, School of Medicine, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Audsley', 'Affiliation': 'Posdoctoral fellow, University of Nottingham, School of Medicine, United Kingdom.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Kendrick', 'Affiliation': 'Professor of Primary Care Research, University of Nottingham, School of Medicine, United Kingdom.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Orton', 'Affiliation': 'Associate Professor and Consultant in Public Health, University of Nottingham, School of Medicine, United Kingdom.'}]",Primary health care research & development,['10.1017/S1463423619000379']
2283,32800022,Community-based self-management of chronic low back pain in a rural African primary care setting: a feasibility study.,"A small pragmatic non-randomised controlled study investigated the feasibility and acceptability of a novel theory-informed community-based self-management programme targeting the biopsychosocial factors associated with chronic low back pain disability in a rural Nigerian primary care centre. Participants either received the programme, once weekly for 6 weeks, or usual care. The programme combined group exercise sessions with group/individual discussion sessions, informed by cognitive behavioural therapy and motivational interviewing. Recruitment rate, intervention delivery, proportion of planned treatment attended, retention/dropout rate, adherence to recommended self-management strategies and biopsychosocial outcomes were used to determine feasibility. Structured qualitative exit feedback interviews ascertained acceptability. Recruitment rate was 100%, treatment uptake was 83% and loss to follow-up was 8%. Greater benefits for the self-management group compared with control were observed for primary and secondary biopsychosocial outcomes. Although the programme appears promising, the exploratory design of this study warrants more rigorous intervention testing following suggested programme improvement.",2019,Greater benefits for the self-management group compared with control were observed for primary and secondary biopsychosocial outcomes.,['rural Nigerian primary care centre'],"['novel theory-informed community-based self-management programme', 'Community-based self-management', 'programme combined group exercise sessions with group/individual discussion sessions, informed by cognitive behavioural therapy and motivational interviewing']","['Recruitment rate, intervention delivery, proportion of planned treatment attended, retention/dropout rate, adherence to recommended self-management strategies and biopsychosocial outcomes', 'Recruitment rate', 'chronic low back pain disability']","[{'cui': 'C1556089', 'cui_str': 'Nigerians'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0700287', 'cui_str': 'Informing'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",,0.0823773,Greater benefits for the self-management group compared with control were observed for primary and secondary biopsychosocial outcomes.,"[{'ForeName': 'Chinonso N', 'Initials': 'CN', 'LastName': 'Igwesi-Chidobe', 'Affiliation': 'Department of Medical Rehabilitation, Faculty of Health Sciences and Technology, College of Medicine, University of Nigeria (Enugu Campus), Enugu, Nigeria.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Godfrey', 'Affiliation': ""Department of Physiotherapy, School of Population Health Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Kitchen', 'Affiliation': ""Department of Physiotherapy, School of Population Health Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Chika N', 'Initials': 'CN', 'LastName': 'Onwasigwe', 'Affiliation': 'Department of Community Medicine, Faculty of Medical Sciences, College of Medicine, University of Nigeria (Enugu Campus), Enugu, Nigeria.'}, {'ForeName': 'Isaac O', 'Initials': 'IO', 'LastName': 'Sorinola', 'Affiliation': ""Department of Physiotherapy, School of Population Health Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]",Primary health care research & development,['10.1017/S1463423619000070']
2284,32800029,[Effect of intermittent versus daily inhalation of budesonide on pulmonary function and fractional exhaled nitric oxide in children with mild persistent asthma].,"OBJECTIVE


To study the effect of intermittent versus daily inhalation of budesonide on pulmonary function and fractional exhaled nitric oxide (FeNO) in children with mild persistent asthma.
METHODS


A total of 120 children, aged 6-14 years, with mild persistent asthma who attended the hospital from January 2016 to January 2018 were enrolled. The children were divided into an intermittent inhalation group with 60 children (inhalation of budesonide 200 μg/day for 6 weeks when symptoms of asthma appeared) and a daily inhalation group with 60 children (continuous inhalation of budesonide 200 μg/day) by stratified randomization. The children were followed up at months 3, 6, 9, and 12 of treatment. The two groups were compared in terms of baseline data, changes in FeNO and pulmonary function parameters, amount of glucocorticoid used, number of asthma attacks, and asthma control.
RESULTS


At the start of treatment, there were no significant differences in baseline data, FeNO, and pulmonary function between the two groups (P>0.05). Over the time of treatment, FeNO gradually decreased and pulmonary function parameters were gradually improved in both groups (P<0.001). Compared with the intermittent inhalation group, the daily inhalation group had a better effect in reducing FeNO and increasing the predicted percentage of forced expiratory volume in 1 second (FEV1%pred) (P<0.001). The inhalation method and treatment time had an interaction effect on FeNO and pulmonary function parameters (P<0.001). In the daily inhalation group, FeNO and lung function parameters were improved rapidly and stabilized after 3 months of treatment, while those in the intermittent inhalation group stabilized after 6 months. After 12 months of treatment, there were no significant differences in the increases in body height and body weight and the degree of disease control between the two groups (P>0.05). Compared with the daily inhalation group, the intermittent inhalation group had a significantly lower amount of budesonide inhaled (P<0.05) and a significantly higher number of asthma attacks (P<0.05).
CONCLUSIONS


Intermittent inhalation and daily inhalation of budesonide can achieve the same level of asthma control in children with mild persistent asthma and both have no influence on the increases in body height and body weight. Daily inhalation of budesonide can produce a better efficiency in reduing FeNO and increasing FEV1%pred. Although intermittent inhalation can reduce the amount of glucocorticoid used, it may lead to a higher risk of asthma attacks.",2020,The inhalation method and treatment time had an interaction effect on FeNO and pulmonary function parameters (P<0.001).,"['children with mild persistent asthma', '120 children, aged 6-14 years, with mild persistent asthma who attended the hospital from January 2016 to January 2018 were enrolled']","['intermittent inhalation group with 60 children (inhalation of budesonide 200\u2005μg/day for 6 weeks when symptoms of asthma appeared) and a daily inhalation group with 60 children (continuous inhalation of budesonide', 'budesonide']","['pulmonary function and fractional exhaled nitric oxide', 'FeNO and lung function parameters', 'number of asthma attacks', 'baseline data, FeNO, and pulmonary function', 'forced expiratory volume', 'body height and body weight and the degree of disease control', 'pulmonary function and fractional exhaled nitric oxide (FeNO', 'FeNO and pulmonary function parameters', 'FeNO', 'pulmonary function parameters', 'body height and body weight', 'FeNO and pulmonary function parameters, amount of glucocorticoid used, number of asthma attacks, and asthma control']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1960046', 'cui_str': 'Mild persistent asthma'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0347950', 'cui_str': 'Acute exacerbation of asthma'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}]",120.0,0.0254881,The inhalation method and treatment time had an interaction effect on FeNO and pulmonary function parameters (P<0.001).,"[{'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Zhang', 'Affiliation': ""Department of Pediatrics, Fifth People's Hospital of Shanghai, Fudan University, Shanghai 200240, China. wxmyj@sina.com.""}, {'ForeName': 'Wen-Xuan', 'Initials': 'WX', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Xiao-Ming', 'Initials': 'XM', 'LastName': 'Wang', 'Affiliation': ''}]",Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics,[]
2285,32800078,"Searching for Personalized Medicine for Binge Drinking Smokers: Smoking Cessation Using Varenicline, Nicotine Patch, or Combination Nicotine Replacement Therapy.","OBJECTIVE


Heavy drinking is common among smokers and is associated with especially poor health outcomes. Varenicline may affect mechanisms and clinical outcomes that are relevant for both smoking cessation and alcohol use. The current study examines whether varenicline, relative to nicotine replacement therapy, yields better smoking cessation outcomes among binge drinking smokers.
METHOD


Secondary data analyses of a comparative effectiveness randomized controlled trial of three smoking cessation pharmacotherapies (12 weeks of varenicline, nicotine patch, or nicotine patch and lozenge) paired with six counseling sessions were conducted. Adult daily cigarette smokers (N = 1,078, 52% female) reported patterns of alcohol use, cigarette craving, and alcohol-related cigarette craving at baseline and over 4 weeks after quitting. Smoking cessation outcome was 7-day biochemically confirmed point-prevalence abstinence.
RESULTS


Binge drinkers had higher relapse rates than moderate drinkers at 4-week post-target quit day but not at the end of treatment or long-term follow up (12 and 26 weeks). Varenicline did not yield superior smoking cessation outcomes among binge drinkers, nor did it affect alcohol use early in the quit attempt. Varenicline did produce relatively large reductions in alcohol-related cigarette craving and overall cigarette craving during the first 4 weeks after quitting.
CONCLUSIONS


Varenicline did not yield higher smoking abstinence rates or reduce alcohol use among binge drinkers. Varenicline did reduce alcohol-related cigarette craving but this did not translate to meaningful differences in smoking abstinence. Varenicline's effects on smoking abstinence do not appear to vary significantly as a function of drinking status.",2020,"Varenicline did produce relatively large reductions in alcohol-related cigarette craving and overall cigarette craving during the first 4 weeks after quitting.
","['Binge Drinking Smokers', 'Adult daily cigarette smokers (N = 1,078, 52% female) reported patterns of alcohol use, cigarette craving, and alcohol-related cigarette craving at baseline and over 4 weeks after quitting', 'binge drinking smokers']","['Varenicline, Nicotine Patch, or Combination Nicotine Replacement Therapy', 'smoking cessation pharmacotherapies', 'Varenicline', 'varenicline', 'nicotine replacement therapy', 'varenicline, nicotine patch, or nicotine patch and lozenge) paired with six counseling sessions']","['alcohol-related cigarette craving', 'smoking abstinence', 'relapse rates', 'alcohol-related cigarette craving and overall cigarette craving', 'Smoking cessation outcome', 'smoking abstinence rates']","[{'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",3.0,0.0099727,"Varenicline did produce relatively large reductions in alcohol-related cigarette craving and overall cigarette craving during the first 4 weeks after quitting.
","[{'ForeName': 'Jesse T', 'Initials': 'JT', 'LastName': 'Kaye', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health (UW-CTRI), Madison, Wisconsin.'}, {'ForeName': 'Adrienne L', 'Initials': 'AL', 'LastName': 'Johnson', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health (UW-CTRI), Madison, Wisconsin.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Cook', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health (UW-CTRI), Madison, Wisconsin.'}]",Journal of studies on alcohol and drugs,[]
2286,32800081,"Effects of Alcohol, Condom Request Style, and State Anger on Men's Condom Use Resistance.","OBJECTIVE


The purpose of this study was to examine the distal predictors (alcohol expectancies, adversarial heterosexual beliefs) and proximal predictors (alcohol intoxication, partner's condom use request style, state anger) of young men's condom use resistance (CUR).
METHOD


Young, male, non-problem drinking, inconsistent condom users (N = 297) completed an alcohol administration experiment. After completing background measures, participants were randomly assigned to receive a control or alcoholic beverage (target peak breath alcohol concentration = .08%). They then read a randomly assigned hypothetical sexual scenario in which their female partner requested to use a condom either indirectly, directly, or insistently. Participants' desire to have condomless sex, state anger, and both coercive and noncoercive CUR intentions were assessed.
RESULTS


Path analyses demonstrated that alcohol intoxication directly predicted noncoercive CUR intentions. In addition, a moderated mediation pathway was found such that, relative to sober participants, intoxicated men's sexual aggression-related alcohol expectancies were positively associated with their state anger in response to the partner's condom use request. This increased anger was related to stronger noncoercive CUR intentions. Adversarial heterosexual beliefs both directly and indirectly predicted coercive and noncoercive CUR intentions.
CONCLUSIONS


Path analysis demonstrated that alcohol intoxication increased intentions to resist condom use through noncoercive tactics. In addition, men's misogynistic attitudes and alcohol intoxication were associated with greater feelings of anger, which predicted stronger coercive and noncoercive CUR intentions.",2020,"Participants' desire to have condomless sex, state anger, and both coercive and noncoercive CUR intentions were assessed.
","['Young, male, non-problem drinking, inconsistent condom users (N = 297) completed an alcohol administration experiment']","['control or alcoholic beverage', 'Alcohol, Condom Request Style, and State Anger']","[""distal predictors (alcohol expectancies, adversarial heterosexual beliefs) and proximal predictors (alcohol intoxication, partner's condom use request style, state anger) of young men's condom use resistance (CUR"", 'noncoercive CUR intentions', 'sexual aggression-related alcohol expectancies', ""Participants' desire to have condomless sex, state anger, and both coercive and noncoercive CUR intentions""]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0442809', 'cui_str': 'Inconsistent'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}]","[{'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0233953', 'cui_str': 'Sexual aggression'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",297.0,0.0222601,"Participants' desire to have condomless sex, state anger, and both coercive and noncoercive CUR intentions were assessed.
","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Cue Davis', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Kirwan', 'Affiliation': 'Edson College of Nursing and Health Innovation, Arizona State University, Phoenix, Arizona.'}, {'ForeName': 'Rhiana', 'Initials': 'R', 'LastName': 'Wegner', 'Affiliation': 'University of Massachusetts, Boston, Boston, Massachusetts.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Neilson', 'Affiliation': 'Department of Psychology, Morehead State University, Morehead, Kentucky.'}, {'ForeName': 'Cynthia A', 'Initials': 'CA', 'LastName': 'Stappenbeck', 'Affiliation': 'Department of Psychology, Georgia State University, Atlanta, Georgia.'}]",Journal of studies on alcohol and drugs,[]
2287,32800099,"Effect of mammographic screening from age 40 years on breast cancer mortality (UK Age trial): final results of a randomised, controlled trial.","BACKGROUND


The appropriate age range for breast cancer screening remains a matter of debate. We aimed to estimate the effect of mammographic screening at ages 40-48 years on breast cancer mortality.
METHODS


We did a randomised, controlled trial involving 23 breast screening units across Great Britain. We randomly assigned women aged 39-41 years, using individual randomisation, stratified by general practice, in a 1:2 ratio, to yearly mammographic screening from the year of inclusion in the trial up to and including the calendar year that they reached age 48 years (intervention group), or to standard care of no screening until the invitation to their first National Health Service Breast Screening Programme (NHSBSP) screen at approximately age 50 years (control group). Women in the intervention group were recruited by postal invitation. Women in the control group were unaware of the study. The primary endpoint was mortality from breast cancers (with breast cancer coded as the underlying cause of death) diagnosed during the intervention period, before the participant's first NHSBSP screen. To study the timing of the mortality effect, we analysed the results in different follow-up periods. Women were included in the primary comparison regardless of compliance with randomisation status (intention-to-treat analysis). This Article reports on long-term follow-up analysis. The trial is registered with the ISRCTN registry, ISRCTN24647151.
FINDINGS


160 921 women were recruited between Oct 14, 1990, and Sept 24, 1997. 53 883 women (33·5%) were randomly assigned to the intervention group and 106 953 (66·5%) to the control group. Between randomisation and Feb 28, 2017, women were followed up for a median of 22·8 years (IQR 21·8-24·0). We observed a significant reduction in breast cancer mortality at 10 years of follow-up, with 83 breast cancer deaths in the intervention group versus 219 in the control group (relative rate [RR] 0·75 [95% CI 0·58-0·97]; p=0·029). No significant reduction was observed thereafter, with 126 deaths versus 255 deaths occurring after more than 10 years of follow-up (RR 0·98 [0·79-1·22]; p=0·86).
INTERPRETATION


Yearly mammography before age 50 years, commencing at age 40 or 41 years, was associated with a relative reduction in breast cancer mortality, which was attenuated after 10 years, although the absolute reduction remained constant. Reducing the lower age limit for screening from 50 to 40 years could potentially reduce breast cancer mortality.
FUNDING


National Institute for Health Research Health Technology Assessment programme.",2020,"No significant reduction was observed thereafter, with 126 deaths versus 255 deaths occurring after more than 10 years of follow-up (RR 0·98 [0·79-1·22]; p=0·86).
","['from age 40 years on breast cancer mortality (UK Age trial', '160\u2008921 women were recruited between Oct 14, 1990, and Sept 24, 1997', '23 breast screening units across Great Britain', 'at ages 40-48 years on breast cancer mortality', 'women aged 39-41 years, using individual randomisation, stratified by general practice, in a 1:2 ratio, to yearly mammographic screening from the year of inclusion in the trial up to and including the calendar year that they reached age 48 years (intervention group), or to', '53\u2008883 women (33·5']","['mammographic screening', 'standard care of no screening until the invitation to their first National Health Service Breast Screening Programme (NHSBSP) screen']","['breast cancer mortality', 'mortality from breast cancers (with breast cancer coded as the underlying cause of death', 'mortality effect']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0730225', 'cui_str': '1997'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0018223', 'cui_str': 'Great Britain'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0456586', 'cui_str': 'Calendar year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",23.0,0.112667,"No significant reduction was observed thereafter, with 126 deaths versus 255 deaths occurring after more than 10 years of follow-up (RR 0·98 [0·79-1·22]; p=0·86).
","[{'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK. Electronic address: s.w.duffy@qmul.ac.uk.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Vulkan', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Cuckle', 'Affiliation': 'Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Dharmishta', 'Initials': 'D', 'LastName': 'Parmar', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Shama', 'Initials': 'S', 'LastName': 'Sheikh', 'Affiliation': ""Cancer Prevention Group, King's College London, London, UK.""}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Smith', 'Affiliation': 'American Cancer Society, Atlanta, GA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Evans', 'Affiliation': 'Division of Cancer Research, University of Dundee, Dundee, UK.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Blyuss', 'Affiliation': 'School of Physics, Astronomy, and Mathematics, University of Hertfordshire, Hatfield, UK; Department of Paediatrics and Paediatric Infectious Diseases, Sechenov First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Johns', 'Affiliation': ""Cancer Prevention Group, King's College London, London, UK.""}, {'ForeName': 'Ian O', 'Initials': 'IO', 'LastName': 'Ellis', 'Affiliation': 'Division of Cancer and Stem Cells, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Myles', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Sasieni', 'Affiliation': ""Cancer Prevention Group, King's College London, London, UK.""}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Moss', 'Affiliation': 'Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London, London, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30398-3']
2288,32800386,Long-term effects of folic acid and vitamin-B12 supplementation on fracture risk and cardiovascular disease: Extended follow-up of the B-PROOF trial.,"BACKGROUND & AIMS


In the initial B-proof, we found inconsistent results of B vitamin supplementation. However, the debate regarding the effects of B vitamins on age-related diseases continues. Therefore, our aim was to investigate the long-term effects (5-7 years follow-up) of an intervention with folic acid and vitamin-B12 supplementation on fracture and cardiovascular disease risk.
METHODS


Extended follow-up of the B-PROOF trial, a multi-center, double-blind randomized placebo-controlled trial designed to assess the effect of 2-3 years daily supplementation with folic acid (400 μg) and vitamin-B12 (500 μg) versus placebo (n = 2,919). Primary outcome was verified self-reported fracture incidence and secondary outcomes were self-reported cardiovascular endpoints, which were collected through a follow-up questionnaires Proportional hazard analyses was used for the effect of the intervention on risk of fracture(s) and logistic regression for the effect of the intervention on risk of cardiovascular disease.
RESULTS


A total of 1,298 individuals (44.5%) participated in the second follow-up round with median of 54 months [51-58], (n = 662 and n = 636, treatment versus placebo group). Median age at baseline was 71.0 years [68.0-76.0] for both groups. No effect was observed of the intervention on osteoporotic fracture or any fracture risk after a follow-up (HR: 0.99, 95% CI: 0.62-1.59 and HR: 0.77; 95% CI: 0.50-1.19, respectively), nor on cardiovascular or cerebrovascular disease risk (OR: 1.05; 95%CI: 0.80-1.44 and OR: 0.85; 95%CI: 0.50-1.45, respectively). Potential interaction by baseline homocysteine concentration was observed for osteoporotic- and any fracture (p = 0.10 and 0.06 respectively), which indicated a significantly lower risk of any fracture in the treatment group with higher total homocysteine concentrations (>15.1 μmol/l). No age-dependent effects were present.
CONCLUSIONS


This study supports and extends previous null-findings of the B-PROOF trial and shows that supplementation of folic acid and vitamin-B12 has no effect on fracture risk, nor on cardiovascular disease in older individuals over a longer follow-up period. However, B-vitamin supplementation may be beneficial in reducing fractures in individuals with high total homocysteine concentrations, a finding which needs to be replicated.",2020,"No effect was observed of the intervention on osteoporotic fracture or any fracture risk after a follow-up (HR: 0.99, 95% CI: 0.62-1.59 and HR: 0.77; 95% CI: 0.50-1.19, respectively), nor on cardiovascular or cerebrovascular disease risk (OR: 1.05; 95%CI: 0.80-1.44 and OR: 0.85; 95%CI: 0.50-1.45, respectively).","['1,298 individuals (44.5%) participated in the second follow-up round with median of 54 months [51-58], (n\xa0=\xa0662 and n\xa0=\xa0636, treatment versus placebo group']","['folic acid (400\xa0μg) and vitamin-B12 (500\xa0μg) versus placebo', 'folic acid and vitamin-B12', 'B vitamins', 'vitamin supplementation', 'folic acid and vitamin-B12 supplementation', 'placebo']","['osteoporotic fracture or any fracture risk', 'baseline homocysteine concentration', 'total homocysteine concentrations', 'fracture risk and cardiovascular disease', 'cardiovascular or cerebrovascular disease risk', 'verified self-reported fracture incidence and secondary outcomes were self-reported cardiovascular endpoints', 'risk of cardiovascular disease']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042849', 'cui_str': 'Vitamin B Complex'}, {'cui': 'C0302837', 'cui_str': 'Vitamin supplement agent'}, {'cui': 'C4524262', 'cui_str': 'Vitamin B12 supplementation'}]","[{'cui': 'C0521170', 'cui_str': 'Osteoporotic fracture'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.549828,"No effect was observed of the intervention on osteoporotic fracture or any fracture risk after a follow-up (HR: 0.99, 95% CI: 0.62-1.59 and HR: 0.77; 95% CI: 0.50-1.19, respectively), nor on cardiovascular or cerebrovascular disease risk (OR: 1.05; 95%CI: 0.80-1.44 and OR: 0.85; 95%CI: 0.50-1.45, respectively).","[{'ForeName': 'Sadaf', 'Initials': 'S', 'LastName': 'Oliai Araghi', 'Affiliation': 'Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands; Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands. Electronic address: s.oliaiaraghi@erasmusmc.nl.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Kiefte-de Jong', 'Affiliation': 'Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands; Department of Public Health and Primary Care, Leiden University Medical Center/LUMC Campus, The Hague, the Netherlands.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'van Dijk', 'Affiliation': 'Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands; Department of Geriatric Medicine, Franciscus Gasthuis & Vlietland, Schiedam, the Netherlands.'}, {'ForeName': 'Karin M A', 'Initials': 'KMA', 'LastName': 'Swart', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of General Practice and Elderly Care Medicine, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Kim J', 'Initials': 'KJ', 'LastName': 'Ploegmakers', 'Affiliation': 'Amsterdam UMC, (University) of Amsterdam, Section of Geriatric Medicine, Department of Internal Medicine, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'M Carola', 'Initials': 'MC', 'LastName': 'Zillikens', 'Affiliation': 'Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Natasja M', 'Initials': 'NM', 'LastName': 'van Schoor', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Lisette C P G M', 'Initials': 'LCPGM', 'LastName': 'de Groot', 'Affiliation': 'Division of Human Nutrition and Health, Wageningen University, Wageningen, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lips', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Internal Medicine, Endocrine Section, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Bruno H', 'Initials': 'BH', 'LastName': 'Stricker', 'Affiliation': 'Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'André G', 'Initials': 'AG', 'LastName': 'Uitterlinden', 'Affiliation': 'Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands; Department of Epidemiology, Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'van der Velde', 'Affiliation': 'Department of Internal Medicine, Erasmus University Medical Center, Rotterdam, the Netherlands; Amsterdam UMC, (University) of Amsterdam, Section of Geriatric Medicine, Department of Internal Medicine, Amsterdam Public Health Research Institute, Amsterdam, the Netherlands.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.07.033']
2289,32800391,The effectiveness of oropharyngeal exercises compared to inspiratory muscle training in obstructive sleep apnea: A randomized controlled trial.,"BACKGROUND


Inspiratory muscle training (IMT) and oropharyngeal exercises (OE) have different advantages and disadvantages and a comparison of these modalities has been recommended. The aim of this study was to compare the effects of IMT and OE on important outcomes for patients with OSAS.
METHODS


This was a randomized controlled clinical trial. Forty-one clinically stable OSAS patients not receiving CPAP therapy were randomly divided into three groups. Patients in the IMT group (n = 15) trained with a threshold loading device 7 days/week for 12 weeks. Patients in the OE group (n = 14) practiced exercises 5 days/week for 12 weeks. Twelve patients served as control group. Apnea-hypopnea index (AHI), respiratory muscle strength, snoring severity and frequency (Berlin Questionnaire), daytime sleepiness (Epworth Sleepiness Scale; ESS), sleep quality (Pittsburg Sleep Quality Index; PSQI), impact of sleepiness on daily life (Functional Outcomes of Sleep Questionnaire; FOSQ), and fatigue severity (Fatigue Severity Scale; FSS) were evaluated before and after the interventions.
RESULTS


AHI and sleep efficiency did not change significantly in any of the groups. Significant decreases in snoring severity and frequency, FSS and PSQI total scores were found in the IMT and OE groups after the treatments (p < 0.05). There was a significant reduction in neck and waist circumference and significant improvement in respiratory muscle strength (MIP and MEP) in IMT group compared to control group (p < 0.05). The%MEPpred value and FOSQ total score significantly increased and ESS score reduced after the treatment in OE group compared to control group (p < 0.05).
CONCLUSIONS


Our results indicate that both OE and IMT rehabilitation interventions are applicable in rehabilitation programs for OSAS patients who do not accept CPAP therapy. Our findings could lead to increase these methods' use among rehabilitation professionals and decrease in cost of CPAP treatment in OSAS.",2020,"Significant decreases in snoring severity and frequency, FSS and PSQI total scores were found in the IMT and OE groups after the treatments (p < 0.05).","['patients with OSAS', 'OSAS patients who do not accept CPAP therapy', 'obstructive sleep apnea', 'Forty-one clinically stable OSAS patients not receiving CPAP therapy', 'Twelve patients served as control group']","['Inspiratory muscle training (IMT) and oropharyngeal exercises (OE', 'OE and IMT rehabilitation interventions', 'oropharyngeal exercises', 'IMT and OE', 'inspiratory muscle training', 'IMT']","['FOSQ total score', 'Apnea-hypopnea index (AHI), respiratory muscle strength, snoring severity and frequency (Berlin Questionnaire), daytime sleepiness (Epworth Sleepiness Scale; ESS), sleep quality (Pittsburg Sleep Quality Index; PSQI), impact of sleepiness on daily life (Functional Outcomes of Sleep Questionnaire; FOSQ), and fatigue severity (Fatigue Severity Scale; FSS', 'ESS score', 'neck and waist circumference', 'snoring severity and frequency, FSS and PSQI total scores', 'respiratory muscle strength (MIP and MEP', 'AHI and sleep efficiency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0037384', 'cui_str': 'Snoring'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0206630', 'cui_str': 'Endometrial stromal sarcoma'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0265224', 'cui_str': 'Freeman-Sheldon syndrome'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",41.0,0.0185838,"Significant decreases in snoring severity and frequency, FSS and PSQI total scores were found in the IMT and OE groups after the treatments (p < 0.05).","[{'ForeName': 'Nurel', 'Initials': 'N', 'LastName': 'Erturk', 'Affiliation': 'Cardiopulmonary Rehabilitation Unit, University of Health Sciences, Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital, Trabzon, Turkey. Electronic address: nrlbllr@gmail.com.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Calik-Kutukcu', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Hulya', 'Initials': 'H', 'LastName': 'Arikan', 'Affiliation': 'Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Atilim University, Ankara, Turkey.'}, {'ForeName': 'Sema', 'Initials': 'S', 'LastName': 'Savci', 'Affiliation': 'School of Physiotherapy and Rehabilitation, Dokuz Eylul University, Izmir, Turkey.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Inal-Ince', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Caliskan', 'Affiliation': 'Department of Chest Medicine and Sleep Center, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Melda', 'Initials': 'M', 'LastName': 'Saglam', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Naciye', 'Initials': 'N', 'LastName': 'Vardar-Yagli', 'Affiliation': 'Faculty of Physical Therapy and Rehabilitation, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Hikmet', 'Initials': 'H', 'LastName': 'Firat', 'Affiliation': 'Department of Chest Medicine and Sleep Center, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Adem', 'Initials': 'A', 'LastName': 'Celik', 'Affiliation': 'Department of Chest Medicine and Sleep Center, University of Health Sciences, Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital, Trabzon, Turkey.'}, {'ForeName': 'Melike', 'Initials': 'M', 'LastName': 'Yuce-Ege', 'Affiliation': 'Department of Chest Medicine and Sleep Center, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Sadik', 'Initials': 'S', 'LastName': 'Ardic', 'Affiliation': 'Department of Chest Medicine and Sleep Center, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}]",Heart & lung : the journal of critical care,['10.1016/j.hrtlng.2020.07.014']
2290,32800398,Effect of licorice on patients with HSD11B1 gene polymorphisms- a pilot study.,"The positive association of HSD11B1 gene polymorphism with type 2 diabetes (T2D) and prediabetic conditions has been revealed. In the current study, we assessed the effectiveness of licorice on the clinical profile of the patients with HSD11B1 gene polymorphism. Licorice (Glycyrrhiza Glabra) is a competitive inhibitor of 11 beta-hydroxysteroid dehydrogenase 1 (11β-HSD1) enzyme and has been traditionally reported as an anti-ulcer, anti-pyretic, anti-thirst, anti-inflammatory, hypoglycemic and hypolipidemic agent. The aim of the study was to assess the effectiveness of licorice on the clinical profile of participants with HSD11B1 gene polymorphism. The study was performed using diabetic patients with HSD11B1 gene polymorphism. Biochemical and anthropometric parameters were measured using standard diagnostic tools. Fourteen patients were divided into two groups by simple randomization, Licorice group (treated with 750 mg licorice/day for three weeks), and placebo group (treated with 750 mg placebo/day for three weeks). Investigations were repeated at the end of three weeks. Licorice showed a significant reduction in serum insulin levels (p = 0.03). There was no significant change in any other clinical parameters either by licorice or placebo. Conclusively, licorice moderately improves serum insulin levels in patients with HSD11B1 gene polymorphism. From our pilot study, the safety of licorice is confirmed at a dose of 750 mg/day. However, the study can be repeated at a higher dose to show its effectiveness and safety.",2020,Licorice showed a significant reduction in serum insulin levels (p = 0.03).,"['participants with HSD11B1 gene polymorphism', 'diabetic patients with HSD11B1 gene polymorphism', 'Fourteen patients', 'patients with HSD11B1 gene polymorphism', 'patients with HSD11B1 gene polymorphisms- a pilot study']","['Licorice (Glycyrrhiza Glabra', 'licorice', 'placebo']","['serum insulin levels', 'Biochemical and anthropometric parameters']","[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}]","[{'cui': 'C0017987', 'cui_str': 'Licorice'}, {'cui': 'C0697105', 'cui_str': 'Glycyrrhiza glabra'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",14.0,0.0509751,Licorice showed a significant reduction in serum insulin levels (p = 0.03).,"[{'ForeName': 'Nayana', 'Initials': 'N', 'LastName': 'Devang', 'Affiliation': 'Department of Biotechnology, National Institute of Technology Calicut, NIT Campus (P.O.), Calicut, 673601, Kerala, India. Electronic address: devangnayana@gmail.com.'}, {'ForeName': 'Prabha', 'Initials': 'P', 'LastName': 'Adhikari', 'Affiliation': 'Department of Medicine, Yenepoya Medical College, Yenepoya University, Mangalore, 575018, Karnataka, India.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nandini', 'Affiliation': 'Department of Biochemistry, Kasturba Medical College, Manipal University, Mangalore, 575003, Karnataka, India.'}, {'ForeName': 'Kapaettu', 'Initials': 'K', 'LastName': 'Satyamoorthy', 'Affiliation': 'Department of Biotechnology, School of Life Sciences, Manipal University, Manipal, 576104, Karnataka, India.'}, {'ForeName': 'Padmalatha S', 'Initials': 'PS', 'LastName': 'Rai', 'Affiliation': 'Department of Biotechnology, School of Life Sciences, Manipal University, Manipal, 576104, Karnataka, India.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2020.06.006']
2291,32800407,Preventing Parastomal Hernia After Ileal Conduit by the Use of a Prophylactic Mesh: A Randomised Study.,"BACKGROUND


Parastomal hernia (PSH) after urinary diversion with ileal conduit is frequently a clinical problem.
OBJECTIVE


To investigate whether a prophylactic lightweight mesh in the sublay position can reduce the cumulative incidence of PSH after open cystectomy with ileal conduit.
DESIGN, SETTING, AND PARTICIPANTS


From 2012 to 2017, we randomised 242 patients 1:1 to conventional stoma construction (n = 124) or prophylactic mesh (n = 118) at three Swedish hospitals (ISRCTN 95093825).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


The primary endpoint was clinical PSH, and secondary endpoints were radiological PSH assessed in prone position with the stoma in the centre of a ring, parastomal bulging, and complications from the mesh.
RESULTS AND LIMITATIONS


Within 24 mo, 20/89 (23%) patients in the control arm and 10/92 (11%) in the intervention arm had developed a clinical PSH (p = 0.06) after a median follow-up of 3 yr, corresponding to a hazard ratio of 0.45 (confidence interval 0.24-0.86, p = 0.02) in the intervention arm. The proportions of radiological PSHs within 24 mo were 22/89 (25%) and 17/92 (19%) in the two study arms. During follow-up, five patients in the control arm and two in the intervention arm were operated for PSH. The median operating time was 50 min longer in patients receiving a mesh. No differences were noted in proportions of Clavien-Dindo complications at 90 d postoperatively or in complications related to the mesh during follow-up.
CONCLUSIONS


Prophylactic implantation of a lightweight mesh in the sublay position decreases the risk of PSH when constructing an ileal conduit without increasing the risk of complications related to the mesh. The median surgical time is prolonged by mesh implantation.
PATIENT SUMMARY


In this randomised report, we looked at the risk of parastomal hernia after cystectomy and urinary diversion with ileal conduit with or without the use of a prophylactic mesh. We conclude that such a prophylactic measure decreased the occurrence of parastomal hernias, with only a slight increase in operating time and no added risk of complications related to the mesh.",2020,"No differences were noted in proportions of Clavien-Dindo complications at 90 d postoperatively or in complications related to the mesh during follow-up.
","['From 2012 to 2017, we randomised 242 patients 1:1 to']","['conventional stoma construction (n\u2009=\u2009124) or prophylactic mesh', 'prophylactic lightweight mesh', 'parastomal hernia after cystectomy and urinary diversion with ileal conduit with or without the use of a prophylactic mesh', 'Parastomal hernia (PSH', 'PSH']","['operating time and no added risk of complications', 'cumulative incidence of PSH', 'proportions of Clavien-Dindo complications', 'Parastomal Hernia', 'occurrence of parastomal hernias', 'median surgical time', 'median operating time', 'radiological PSH assessed in prone position with the stoma in the centre of a ring, parastomal bulging, and complications from the mesh', 'proportions of radiological PSHs', 'clinical PSH']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0403066', 'cui_str': 'Construction worker'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0341539', 'cui_str': 'Parastomal hernia'}, {'cui': 'C0010651', 'cui_str': 'Bladder excision'}, {'cui': 'C0042020', 'cui_str': 'Urinary diversion procedure'}, {'cui': 'C0348002', 'cui_str': 'Ileal Conduit'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0341539', 'cui_str': 'Parastomal hernia'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.145442,"No differences were noted in proportions of Clavien-Dindo complications at 90 d postoperatively or in complications related to the mesh during follow-up.
","[{'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Liedberg', 'Affiliation': 'Institution of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden. Electronic address: fredrik.liedberg@med.lu.se.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Kollberg', 'Affiliation': 'Institution of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden; Department of Urology, Helsingborg County Hospital, Helsingborg, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Allerbo', 'Affiliation': 'Department of Urology, Helsingborg County Hospital, Helsingborg, Sweden.'}, {'ForeName': 'Gediminas', 'Initials': 'G', 'LastName': 'Baseckas', 'Affiliation': 'Institution of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Brändstedt', 'Affiliation': 'Institution of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Sigurdur', 'Initials': 'S', 'LastName': 'Gudjonsson', 'Affiliation': 'Department of Urology, Landspitali University Hospital, Reykjavik, Iceland.'}, {'ForeName': 'Oskar', 'Initials': 'O', 'LastName': 'Hagberg', 'Affiliation': 'Institution of Translational Medicine, Lund University, Malmö, Sweden; Regional Cancer Centre South, Region Skåne, Lund, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Håkansson', 'Affiliation': 'Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jerlström', 'Affiliation': 'Department of Urology, School of Health and Medical Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Annica', 'Initials': 'A', 'LastName': 'Löfgren', 'Affiliation': 'Institution of Translational Medicine, Lund University, Malmö, Sweden.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Patschan', 'Affiliation': 'Institution of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Sörenby', 'Affiliation': 'Institution of Translational Medicine, Lund University, Malmö, Sweden; Department of Urology, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Bläckberg', 'Affiliation': 'Department of Urology, Helsingborg County Hospital, Helsingborg, Sweden.'}]",European urology,['10.1016/j.eururo.2020.07.033']
2292,32800493,Impact of Granulocyte Colony-Stimulating Factor (G-CSF) and Epoetin (EPO) on Hematologic Toxicities and Quality of Life in Patients During Adjuvant Chemotherapy in Early Breast Cancer: Results From the Multi-Center Randomized ADEBAR Trial.,"BACKGROUND


Hematologic toxicities are one of the greatest challenges in adjuvant chemotherapy for breast cancer. This analysis of the ADEBAR trial aims to evaluate application and effect of granulocyte colony-stimulating factor (G-CSF) and epoetin alfa (EPO) on hematologic parameters and fatigue in patients with breast cancer during chemotherapy.
PATIENTS AND METHODS


In the ADEBAR trial, 1493 patients with node-positive primary breast cancer were randomized to either 6 × 5-fluorouracil, epirubicin, and cyclophosphamide (FEC120) or 4 × epirubicin and cyclophosphamide followed by 4 × docetaxel (EC-DOC). Co-medication with G-CSF or EPO was applied to treat chemotherapy-induced leukopenia or anemia. Fatigue was assessed at baseline and after one-half of the chemotherapy.
RESULTS


In total, 899 patients could be included in the analysis. There was no evidence for an association between leucocyte or hemoglobin levels and application of G-CSF and EPO in the preceding cycle, respectively. Hemoglobin levels (B = -0.41; P < .001) were affected by treatment regimen. Fatigue during chemotherapy was mostly affected by the level of fatigue before the start of chemotherapy (B = 0.41; P < .001). Patients with G-CSF application in the preceding cycle showed an increased fatigue score (B = 5.43; P = .02).
CONCLUSION


We showed that fatigue during adjuvant chemotherapy was mostly affected by the level of fatigue present before the start of chemotherapy. This result suggests that the level of fatigue before the start of treatment should be included as an important factor when deciding on type and toxicity of chemotherapy in early breast cancer.",2020,"There was no evidence for an association between leucocyte or hemoglobin levels and application of G-CSF and EPO in the preceding cycle, respectively.","['Early Breast Cancer', 'breast cancer', '1493 patients with node-positive primary breast cancer', 'Patients', '899 patients could be included in the analysis', 'patients with breast cancer during chemotherapy']","['epirubicin and cyclophosphamide', 'Adjuvant Chemotherapy', 'granulocyte colony-stimulating factor (G-CSF) and epoetin alfa (EPO', 'Granulocyte Colony-Stimulating Factor (G-CSF) and Epoetin (EPO', '5-fluorouracil, epirubicin, and cyclophosphamide (FEC120) or', 'Co-medication with G-CSF or EPO']","['Hemoglobin levels', 'leukopenia or anemia', 'Hematologic Toxicities and Quality of Life', 'fatigue score', 'leucocyte or hemoglobin levels and application of G-CSF and EPO', 'Fatigue', 'hematologic parameters and fatigue']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0023516', 'cui_str': 'Leukocyte'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0079459', 'cui_str': 'Colony-stimulating factor, granulocytic'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",1493.0,0.0476588,"There was no evidence for an association between leucocyte or hemoglobin levels and application of G-CSF and EPO in the preceding cycle, respectively.","[{'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Bekes', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany. Electronic address: inga.bekes@uniklinik-ulm.de.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eichler', 'Affiliation': 'Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Singer', 'Affiliation': 'Insitute of Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Centre Mainz, Mainz, Germany.'}, {'ForeName': 'Thomas W P', 'Initials': 'TWP', 'LastName': 'Friedl', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Breast Cancer Center, Department of Obstetrics and Gynecology, University of Munich, Munich, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Rack', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Forstbauer', 'Affiliation': 'Hemato-Oncological Practice Dres Forstbauer and Ziske, Troisdorf, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Dannecker', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Augsburg, Augsburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Kiechle', 'Affiliation': 'Department of Obstetrics and Gynecology, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Krisztian', 'Initials': 'K', 'LastName': 'Lato', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Janni', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Visnja', 'Initials': 'V', 'LastName': 'Fink', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Ulm, Ulm, Germany.'}]",Clinical breast cancer,['10.1016/j.clbc.2020.03.008']
2293,32800494,Phase 1 Dose-Escalation Study of Triweekly Nab-Paclitaxel Combined With S-1 for HER2-Negative Metastatic Breast Cancer.,"PURPOSE


To evaluate the efficacy, toxicity, maximum tolerated dose, and recommended dose of triweekly nab-paclitaxel (nab-PTX) and S-1 combination chemotherapy for patients with metastatic breast cancer.
PATIENTS AND METHODS


This phase 1 study was conducted with a standard 3 + 3 dose escalation design. Every 3 weeks, the patients received nab-PTX at 180-260 mg/m 2  on day 1 and S-1 at 65-80 mg/m 2  daily on days 1 to 14.
RESULTS


Ten HER2-negative metastatic breast cancer patients were enrolled; their median number of prior chemotherapy regimens was 3. Dose-limiting toxicity was observed in the first patient assigned to level 4; grade 4 febrile neutropenia and grade 3 neurotoxicity such as needing a wheelchair occurred. Therefore, an additional patient was not assigned to level 4. The maximum tolerated dose was considered level 4 (260 mg/m 2  nab-PTX with 80 mg/m 2  S-1). The recommended dose determined was level 3 (220 mg/m 2  nab-PTX with 80 mg/m 2  S-1). The response rate was 60.0%. The disease control rate was 70.0%.
CONCLUSION


This combination chemotherapy therapy was feasible and safe for patients with HER2-negative metastatic breast cancer.",2020,Dose-limiting toxicity was observed in the first patient assigned to level 4; grade 4 febrile neutropenia and grade 3 neurotoxicity such as needing a wheelchair occurred.,"['patients with metastatic breast cancer', 'patients with HER2-negative metastatic breast cancer', 'Ten HER2-negative metastatic breast cancer patients', 'HER2-Negative Metastatic Breast Cancer']","['triweekly nab-paclitaxel (nab-PTX) and S-1 combination chemotherapy', 'chemotherapy therapy', 'Triweekly Nab-Paclitaxel Combined With S-1', 'nab-PTX']","['disease control rate', 'Dose-limiting toxicity', 'response rate', 'efficacy, toxicity, maximum tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}]","[{'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.0378932,Dose-limiting toxicity was observed in the first patient assigned to level 4; grade 4 febrile neutropenia and grade 3 neurotoxicity such as needing a wheelchair occurred.,"[{'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Morimoto', 'Affiliation': 'Department of Thoracic, Endocrine Surgery and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School, Kuramoto-cho, Tokushima, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Toba', 'Affiliation': 'Department of Thoracic, Endocrine Surgery and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School, Kuramoto-cho, Tokushima, Japan. Electronic address: ht1109@tokushima-u.ac.jp.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Aoyama', 'Affiliation': 'Department of Thoracic, Endocrine Surgery and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School, Kuramoto-cho, Tokushima, Japan.'}, {'ForeName': 'Misako', 'Initials': 'M', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Surgery, Takamatsu Municipal Hospital, Busshozan-cho, Takamatsu, Japan.'}, {'ForeName': 'Hirokazu', 'Initials': 'H', 'LastName': 'Takechi', 'Affiliation': 'Department of Surgery, Shikoku Central Hospital of the Mutual Aid Association of Public School Teachers, Kawanoe-cho, Shikokuchuo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Department of Thoracic, Endocrine Surgery and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School, Kuramoto-cho, Tokushima, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Tangoku', 'Affiliation': 'Department of Thoracic, Endocrine Surgery and Oncology, Institute of Biomedical Sciences, Tokushima University Graduate School, Kuramoto-cho, Tokushima, Japan.'}]",Clinical breast cancer,['10.1016/j.clbc.2020.07.012']
2294,32800508,NT-proBNP Response to Sacubitril/Valsartan in Hospitalized Heart Failure Patients With Reduced Ejection Fraction: TRANSITION Study.,"OBJECTIVES


This study examined the effects of sacubitril/valsartan on N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and determined patient characteristics associated with favorable NT-proBNP reduction response.
BACKGROUND


NT-proBNP levels reflect cardiac wall stress and predict event risk in patients with acute decompensated heart failure (ADHF).
METHODS


Post-hoc analysis of the TRANSITION (Comparison of Pre- and Post-discharge Initiation of Sacubitril/Valsartan Therapy in HFrEF Patients After an Acute Decompensation Event) study, including stabilized ADHF patients with reduced ejection fraction, randomized to open-label sacubitril/valsartan initiation in-hospital (pre-discharge) versus post-discharge. NT-proBNP was measured at randomization (baseline), discharge, and 4 and 10 weeks post-randomization. A favorable NT-proBNP response was defined as reduction to ≤1,000 pg/ml or >30% from baseline.
RESULTS


In patients receiving sacubitril/valsartan in-hospital, NT-proBNP was reduced by 28% at discharge, with 46% of patients obtaining favorable NT-proBNP reduction response compared with a 4% reduction and 18% favorable response rate in patients initiated post-discharge (p < 0.001). NT-proBNP was reduced similarly in patients initiating sacubitril/valsartan pre- and post-discharge (reduction at 4 weeks: 25%/22%; 10 weeks: 38%/34%) with comparable favorable response rates (46%/42% and 51%/48% at 4 and 10 weeks, respectively). NT-proBNP favorable response at 4 weeks was associated with lower risk of first heart failure (HF) rehospitalization or cardiovascular death through 26 weeks (hazard ratio: 0.57; 95% confidence interval [CI]: 0.38 to 0.86; p = 0.007). Predictors of a favorable response at 4 weeks were starting dose ≥49/51 mg twice daily, higher baseline NT-proBNP, lower baseline serum creatinine, de novo HF, no atrial fibrillation, angiotensin-converting enzyme inhibitor-naive or angiotensin receptor blocker-naive, and no prior myocardial infarction.
CONCLUSIONS


In-hospital initiation of sacubitril/valsartan produced rapid reductions in NT-proBNP, statistically significant at discharge. A favorable NT-proBNP response over time was associated with a better prognosis and predicted by higher starting dose and predisposing clinical profile. (Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event [TRANSITION]; NCT02661217).",2020,A favorable NT-proBNP response over time was associated with a better prognosis and predicted by higher starting dose and predisposing clinical profile.,"['patients with acute decompensated heart failure (ADHF', 'HFrEF Patients', 'Failure Patients With Reduced Ejection Fraction', 'Hospitalized Heart', 'stabilized ADHF patients with reduced ejection fraction']","['LCZ696 Therapy', 'proBNP', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'Sacubitril/Valsartan Therapy', 'open-label sacubitril/valsartan initiation in-hospital (pre-discharge) versus post-discharge']","['lower risk of first heart failure (HF) rehospitalization or cardiovascular death', 'favorable NT-proBNP reduction response', 'NT-proBNP', 'N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels', 'response rates', 'baseline serum creatinine, de novo HF, no atrial fibrillation, angiotensin-converting enzyme inhibitor-naive or angiotensin receptor blocker-naive, and no prior myocardial infarction', 'response rate', 'favorable NT-proBNP response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}]","[{'cui': 'C2933615', 'cui_str': 'LCZ 696'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}]",,0.162888,A favorable NT-proBNP response over time was associated with a better prognosis and predicted by higher starting dose and predisposing clinical profile.,"[{'ForeName': 'Domingo', 'Initials': 'D', 'LastName': 'Pascual-Figal', 'Affiliation': 'Cardiology Department, Virgen de la Arrixaca University Hospital, Universidad de Murcia, Murcia, Spain; Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain. Electronic address: dpascual@um.es.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Wachter', 'Affiliation': 'Clinic and Policlinic for Cardiology, University Hospital Leipzig, Leipzig, Germany; Clinic for Cardiology and Pneumology, University Medical Center Göttingen, Göttingen, Germany; German Cardiovascular Research Center, partner site Göttingen, Göttingen, Germany.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Senni', 'Affiliation': 'Cardiology Division, Cardiovascular Department, Papa Giovanni XXIII Hospital, Bergamo, Italy.'}, {'ForeName': 'Weibin', 'Initials': 'W', 'LastName': 'Bao', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, New Jersey.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Noè', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Schwende', 'Affiliation': 'Cardiology Department, Virgen de la Arrixaca University Hospital, Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Butylin', 'Affiliation': 'Cardiology Department, Virgen de la Arrixaca University Hospital, Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Prescott', 'Affiliation': 'Novartis Pharmaceuticals, East Hanover, New Jersey.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Heart failure,['10.1016/j.jchf.2020.05.012']
2295,32800511,Efficacy and Safety of Sacubitril/Valsartan by Dose Level Achieved in the PIONEER-HF Trial.,"OBJECTIVES


This study sought to evaluate the efficacy and safety of sacubitril/valsartan according to dose level achieved in the PIONEER-HF (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode) trial.
BACKGROUND


In patients hospitalized for acute decompensated heart failure (ADHF), in-hospital initiation and continuation of sacubitril/valsartan as compared with enalapril is well tolerated, achieves a greater reduction in N-terminal pro-B-type natriuretic peptide (NT-proBNP), and reduces the risk of cardiovascular death or rehospitalization for HF through 8 weeks. However, not all patients achieve the target dose of sacubitril/valsartan, and its efficacy and safety in such patients are of interest.
METHODS


PIONEER-HF was a randomized, double-blind, active-controlled trial of sacubitril/valsartan versus enalapril in 881 patients stabilized during hospitalization for ADHF. Blinded study medication was administered for 8 weeks, with initial dosing selected based on the systolic blood pressure at randomization and titrated toward a target of sacubitril/valsartan 97/103 mg twice daily, or enalapril 10 mg twice daily, with an algorithm based on systolic blood pressure and the investigator's assessment of tolerability.
RESULTS


At 4 weeks, 199 (55%) patients allocated to sacubitril/valsartan and 211 (60%) patients allocated to enalapril were dispensed the target dose. Baseline characteristics were similar in the 2 treatment groups within each dose level. There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction  = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction  = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
CONCLUSIONS


In hemodynamically stabilized patients with ADHF, the efficacy and safety of sacubitril/valsartan are generally consistent across dose levels. (Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode [PIONEER-HF]; NCT02554890).",2020,"There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction  = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction  = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
","['patients hospitalized for acute decompensated heart failure (ADHF), in-hospital initiation and continuation of sacubitril', 'Patients', '881 patients stabilized during hospitalization for ADHF']","['valsartan', 'Sacubitril/Valsartan Versus Enalapril', 'enalapril', 'sacubitril/valsartan', 'Sacubitril/Valsartan', 'sacubitril/valsartan 97/103\xa0mg twice daily, or enalapril', 'sacubitril/valsartan versus enalapril']","['Efficacy and Safety', 'cardiovascular death or rehospitalization for heart failure', 'NT-proBNP', 'efficacy and safety', 'systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C4033447', 'cui_str': 'sacubitril'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",881.0,0.206586,"There was no heterogeneity across dose levels in the effect of sacubitril/valsartan on the reduction in NT-proBNP (p interaction  = 0.69), the reduction in cardiovascular death or rehospitalization for heart failure (p interaction  = 0.42), or the pre-specified adverse events of special interest through 8 weeks.
","[{'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Berg', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: dberg1@bwh.harvard.edu.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'DeVore', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Lala', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Pinney', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Carol I', 'Initials': 'CI', 'LastName': 'Duffy', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.'}, {'ForeName': 'Yared', 'Initials': 'Y', 'LastName': 'Gurmu', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Velazquez', 'Affiliation': 'Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JACC. Heart failure,['10.1016/j.jchf.2020.06.008']
2296,32806471,Capecitabine in combination with oxaliplatin or irinotecan in elderly patients with advanced colorectal cancer: results of a randomised phase II study.,,2010,,['elderly patients with advanced colorectal cancer'],"['Capecitabine', 'oxaliplatin or irinotecan']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]",[],,0.0144372,,"[{'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Price', 'Affiliation': 'Department of Oncology, The Queen Elizabeth Hospital, Adelaide, Australia. Electronic address: timothy.price@health.sa.gov.au.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Townsend', 'Affiliation': 'Department of Oncology, The Queen Elizabeth Hospital, Adelaide, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Khattak', 'Affiliation': 'Department of Oncology, The Queen Elizabeth Hospital, Adelaide, Australia.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq450']
2297,32806525,Face-to-Face Exercises Performed by Instructors to Improve the Mental Health of Japanese in the Community-A Randomized Control Trial.,"Background and objectives:  The purpose of this study is to clarify the effects on the mental health of face-to-face exercise performed by an instructor (lesson-style Group: Group L) and exercise using machines (program-style Group: Group P) by randomized control trial.  Materials and Methods:  Among 120 subjects, 117 subjects were allocated to two groups with stratified randomization by sex (Group P: 58 subjects; Group L: 59 subjects). A 60-min health exercise class was held once per week for 12 consecutive weeks. The measurement items were mental health as a primary evaluation item and self-efficacy as a secondary evaluation item. Physical fitness was also measured using a new physical fitness test used in Japan. The 12-item general health questionnaire (GHQ-12) was used to measure mental health and the general self-efficacy scale (GSES) was used to measure self-efficacy.  Results:  After the intervention, 102 subjects were analyzed. The changes in mental health evaluated by GHQ-12 scores were significantly lower in Group L -0.7 (95% CI, -1.2 to -0.3) than Group P -0.1 (95% CI, -0.4 to 0.2) ( p  = 0.03). The changes in self-efficacy evaluated by GSES scores were significantly higher in Group P 5.3 (95% CI, 3.1 to 7.5) than Group L 1.3 (95% CI, -0.4 to 3.1) ( p  < 0.01).  Conclusions:  Compared with program exercises mainly using machines, face-to-face exercises performed by instructors improved mental health.",2020,"The changes in mental health evaluated by GHQ-12 scores were significantly lower in Group L -0.7 (95% CI, -1.2 to -0.3) than Group P -0.1 (95% CI, -0.4 to 0.2) ( p  = 0.03).","['102 subjects were analyzed', '120 subjects', '117 subjects']",['instructor (lesson-style Group: Group L) and exercise using machines (program-style Group: Group P'],"['12-item general health questionnaire (GHQ-12', 'mental health evaluated by GHQ-12 scores', 'mental health', 'mental health and the general self-efficacy scale (GSES', 'Physical fitness', 'self-efficacy evaluated by GSES scores']","[{'cui': 'C4319550', 'cui_str': '120'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441846', 'cui_str': 'Group L'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0441849', 'cui_str': 'Group P'}]","[{'cui': 'C4274135', 'cui_str': '12 item General Health Questionnaire'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",117.0,0.0284453,"The changes in mental health evaluated by GHQ-12 scores were significantly lower in Group L -0.7 (95% CI, -1.2 to -0.3) than Group P -0.1 (95% CI, -0.4 to 0.2) ( p  = 0.03).","[{'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Katayama', 'Affiliation': 'Faculty of Sociology, Shikoku Gakuin University, Zentsuji-shi, Kagawa 765-8505, Japan.'}, {'ForeName': 'Kanae', 'Initials': 'K', 'LastName': 'Kanda', 'Affiliation': 'Department of Public Health, Faculty of Medicine, Kagawa University, Kita-gun, Kagawa 761-0701, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Hase', 'Affiliation': 'Department of Clinical Psychology, Faculty of Medicine, Kagawa University, Kita-gun, Kagawa 761-0701, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Miyatake', 'Affiliation': 'Department of Hygiene, Faculty of Medicine, Kagawa University, Kita-gun, Kagawa 761-0701, Japan.'}]","Medicina (Kaunas, Lithuania)",['10.3390/medicina56080404']
2298,32806584,Stopping the Drop: Examining the Impact of a Pilot Physical Literacy-Based Intervention Program on Physical Activity Behaviours and Fitness during the Transition into University.,"The move to university is a major life transition associated with precipitous declines in physical activity (PA). While it remains unclear how these declines can be best attenuated, the concept of physical literacy (PL) or enhancements of PL may be a promising modality to promote PA during life transitions. The purpose of the current study was to evaluate the impact of a pilot PL-based intervention on PA and fitness for students transitioning into university. Participants included 65 first-year students ( M age  = 17.85 ± 0.51;  n  = 46 females), enrolled in a quasi-experimental study. Intervention participants ( n  = 26) participated in a 12-week novel movement skills program conducted in a group-based environment. Results from the 2 × 2 repeated measures ANOVA found moderate effects in the time by condition interaction  F (1,56) = 2.70,  p  = 0.11, η p 2  = 0.08 for PA behaviors as well as for estimated cardiorespiratory fitness  F (1,61) = 8.35,  p  = 0.005, η p 2  = 0.12. Findings from our pilot program suggest that PL may be an effective modality to help first-year university students maintain fitness and attenuate the declines in PA behaviors when transitioning into university. Similar trials with larger samples are required.",2020,Findings from our pilot program suggest that PL may be an effective modality to help first-year university students maintain fitness and attenuate the declines in PA behaviors when transitioning into university.,"['Participants included 65 first-year students ( M age  = 17.85 ± 0.51;  n  = 46 females), enrolled in a quasi-experimental study', 'Intervention participants ( n  = 26) participated in a 12-week', 'students transitioning into university']","['novel movement skills program conducted in a group-based environment', 'Pilot Physical Literacy-Based Intervention Program', 'pilot PL-based intervention']",['PA behaviors'],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2985410', 'cui_str': 'Controlled Clinical Trials, Non-Randomized'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",65.0,0.0154813,Findings from our pilot program suggest that PL may be an effective modality to help first-year university students maintain fitness and attenuate the declines in PA behaviors when transitioning into university.,"[{'ForeName': 'Matthew Y W', 'Initials': 'MYW', 'LastName': 'Kwan', 'Affiliation': 'Department of Family Medicine, David Braley Health Sciences Centre, McMaster University, 100 Main St W, 5th Floor Research, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Jeffrey D', 'Initials': 'JD', 'LastName': 'Graham', 'Affiliation': 'Department of Family Medicine, David Braley Health Sciences Centre, McMaster University, 100 Main St W, 5th Floor Research, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Cierra', 'Initials': 'C', 'LastName': 'Healey', 'Affiliation': 'Department of Family Medicine, David Braley Health Sciences Centre, McMaster University, 100 Main St W, 5th Floor Research, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Paolucci', 'Affiliation': 'Department of Family Medicine, David Braley Health Sciences Centre, McMaster University, 100 Main St W, 5th Floor Research, Hamilton, ON L8S 4K1, Canada.'}, {'ForeName': 'Denver M', 'Initials': 'DM', 'LastName': 'Brown', 'Affiliation': 'Department of Family Medicine, David Braley Health Sciences Centre, McMaster University, 100 Main St W, 5th Floor Research, Hamilton, ON L8S 4K1, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17165832']
2299,32806649,The Effect of Supportive Implementation of Healthier Canteen Guidelines on Changes in Dutch School Canteens and Student Purchase Behaviour.,"We developed an implementation plan including several components to support implementation of the ""Guidelines for Healthier Canteens"" in Dutch secondary schools. This study evaluated the effect of this plan on changes in the school canteen and on food and drink purchases of students. In a 6 month quasi-experimental study, ten intervention schools (IS) received support implementing the guidelines, and ten control schools (CS) received only the guidelines. Changes in the health level of the cafeteria and vending machines were assessed and described. Effects on self-reported purchase behaviour of students were analysed using mixed logistic regression analyses. IS scored higher on healthier availability in the cafeteria (77.2%) and accessibility (59.0%) compared to CS (60.1%, resp. 50.0%) after the intervention. IS also showed more changes in healthier offers in the cafeteria (range -3 to 57%, mean change 31.4%) and accessibility (range 0 to 50%, mean change 15%) compared to CS (range -9 to 46%, mean change 9.7%; range -30 to 20% mean change 7% resp.). Multi-level logistic regression analyses on the intervention/control and health level of the canteen in relation to purchase behaviour showed no relevant relations. In conclusion, the offered support resulted in healthier canteens. However, there was no direct effect on students' purchase behaviour during the intervention.",2020,"IS scored higher on healthier availability in the cafeteria (77.2%) and accessibility (59.0%) compared to CS (60.1%, resp.","['school canteen and on food and drink purchases of students', 'Dutch School Canteens and Student Purchase Behaviour']","['intervention schools (IS) received support implementing the guidelines, and ten control schools (CS', 'Healthier Canteen Guidelines']",['healthier canteens'],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0524819', 'cui_str': 'Foods and drinks'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.0174127,"IS scored higher on healthier availability in the cafeteria (77.2%) and accessibility (59.0%) compared to CS (60.1%, resp.","[{'ForeName': 'Irma J', 'Initials': 'IJ', 'LastName': 'Evenhuis', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, De Boelelaan 1085, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Suzanne M', 'Initials': 'SM', 'LastName': 'Jacobs', 'Affiliation': 'Netherlands Nutrition Centre, PO Box 85700, 2508 CK The Hague, The Netherlands.'}, {'ForeName': 'Ellis L', 'Initials': 'EL', 'LastName': 'Vyth', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, De Boelelaan 1085, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Lydian', 'Initials': 'L', 'LastName': 'Veldhuis', 'Affiliation': 'Netherlands Nutrition Centre, PO Box 85700, 2508 CK The Hague, The Netherlands.'}, {'ForeName': 'Michiel R', 'Initials': 'MR', 'LastName': 'de Boer', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, De Boelelaan 1085, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Jacob C', 'Initials': 'JC', 'LastName': 'Seidell', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, De Boelelaan 1085, 1081 HV Amsterdam, The Netherlands.'}, {'ForeName': 'Carry M', 'Initials': 'CM', 'LastName': 'Renders', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam Public Health Research Institute, De Boelelaan 1085, 1081 HV Amsterdam, The Netherlands.'}]",Nutrients,['10.3390/nu12082419']
2300,32806711,"The Effect of Leucine-Enriched Essential Amino Acid Supplementation on Anabolic and Catabolic Signaling in Human Skeletal Muscle after Acute Resistance Exercise: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparison Trial.","Resistance exercise transiently activates anabolic and catabolic systems in skeletal muscle. Leucine-enriched essential amino acids (LEAAs) are reported to stimulate the muscle anabolic response at a lower dose than whey protein. However, little is known regarding the effect of LEAA supplementation on the resistance exercise-induced responses of the anabolic and catabolic systems. Here, we conducted a randomized, double-blind, placebo-controlled, parallel-group comparison trial to investigate the effect of LEAA supplementation on mechanistic target of rapamycin complex 1 (mTORC1), the ubiquitin-proteasome system and inflammatory cytokines after a single bout of resistance exercise in young men. A total of 20 healthy young male subjects were supplemented with either 5 g of LEAA or placebo, and then they performed 10 reps in three sets of leg extensions and leg curls (70% one-repetition maximum). LEAA supplementation augmented the phosphorylation of mTOR Ser2448  (+77.1%,  p  < 0.05), p70S6K Thr389  (+1067.4%,  p  < 0.05), rpS6 Ser240/244  (+171.3%,  p  < 0.05) and 4EBP1 Thr37/46  (+33.4%,  p  < 0.05) after resistance exercise. However, LEAA supplementation did not change the response of the ubiquitinated proteins, MuRF-1 and Atrogin-1 expression. Additionally, the mRNA expression of IL-1β and IL-6 did not change. These data indicated that LEAA supplementation augments the effect of resistance exercise by enhancing mTORC1 signal activation after exercise.",2020,"LEAA supplementation augmented the phosphorylation of mTOR Ser2448  (+77.1%,  p  < 0.05), p70S6K Thr389  (+1067.4%,  p  < 0.05), rpS6 Ser240/244  (+171.3%,  p  < 0.05) and 4EBP1 Thr37/46  (+33.4%,  p  < 0.05) after resistance exercise.","['20 healthy young male subjects', 'young men', 'skeletal muscle', 'Human Skeletal Muscle after Acute Resistance Exercise']","['Placebo', 'Resistance exercise', 'Leucine-enriched essential amino acids (LEAAs', 'Leucine-Enriched Essential Amino Acid Supplementation', 'LEAA or placebo', 'LEAA supplementation', 'placebo']","['phosphorylation of mTOR Ser2448', 'mRNA expression of IL-1β and IL-6', 'response of the ubiquitinated proteins, MuRF-1 and Atrogin-1 expression', '4EBP1 Thr37/46']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0002525', 'cui_str': 'Essential amino acid'}, {'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C1307407', 'cui_str': 'FRAP1 protein, human'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1956096', 'cui_str': 'Ubiquitinated Proteins'}, {'cui': 'C0968461', 'cui_str': 'TRIM63 protein, human'}]",20.0,0.352585,"LEAA supplementation augmented the phosphorylation of mTOR Ser2448  (+77.1%,  p  < 0.05), p70S6K Thr389  (+1067.4%,  p  < 0.05), rpS6 Ser240/244  (+171.3%,  p  < 0.05) and 4EBP1 Thr37/46  (+33.4%,  p  < 0.05) after resistance exercise.","[{'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Takegaki', 'Affiliation': 'Ritsumeikan Global Innovation Research Organization, Ritsumeikan University, Kusatsu, 525-8577, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Sase', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, 525-8577, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yasuda', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, 525-8577, Japan.'}, {'ForeName': 'Daichi', 'Initials': 'D', 'LastName': 'Shindo', 'Affiliation': 'Ajinomoto Co., Inc., Tokyo 104-8315, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kato', 'Affiliation': 'Ajinomoto Co., Inc., Tokyo 104-8315, Japan.'}, {'ForeName': 'Sakiko', 'Initials': 'S', 'LastName': 'Toyoda', 'Affiliation': 'Ajinomoto Co., Inc., Tokyo 104-8315, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Ajinomoto Co., Inc., Tokyo 104-8315, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Shinohara', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, 525-8577, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fujita', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Kusatsu, 525-8577, Japan.'}]",Nutrients,['10.3390/nu12082421']
2301,32806754,"Implementation of the WHO Approved ""Tailoring Antimicrobial Resistance Programs (TAP)"" Reduces Patients' Request for Antibiotics.","The misuse of antibiotics is a worldwide public health concern. Behavioral Intervention programs that aim to reduce patients' own request for antibiotics during their visit to primary care clinics is an attractive strategy to combat this problem. We tested the effectiveness of a behavioral modification method known as the Tailoring Antimicrobial resistance Programs (TAP) in reducing the request for antibiotics by patients visiting primary care clinics for mild upper respiratory tract infections (URTIs). A stratified cluster randomized design with two groups pre-post, comparing intervention with the control, was conducted in six health centers. TAP was implemented for eight weeks. Request for antibiotics was assessed before (period 1) and after introducing TAP (period 2). The percentage of patients or their escorts who requested antibiotics in period 1 was 59.7% in the control group and 60.2% in the intervention group. The percentage of patients who requested antibiotics did not significantly change between period 1 and 2 in the control group, who continued to receive the standard of care. The above percentage significantly decreased in the intervention group from 60.2% to 38.5% ( p  < 0.05). We conclude that behavioral change programs including TAP are a viable alternative strategy to address antibiotic misuse in Jordan.",2020,"The percentage of patients who requested antibiotics did not significantly change between period 1 and 2 in the control group, who continued to receive the standard of care.",['patients visiting primary care clinics for mild upper respiratory tract infections (URTIs'],"['Behavioral Intervention programs', 'TAP', 'Antimicrobial resistance Programs (TAP']",['percentage of patients or their escorts who requested antibiotics'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]",,0.0222812,"The percentage of patients who requested antibiotics did not significantly change between period 1 and 2 in the control group, who continued to receive the standard of care.","[{'ForeName': 'Nasser M', 'Initials': 'NM', 'LastName': 'Kaplan', 'Affiliation': 'Department of Pathology and Microbiology, Faculty of Medicine, Jordan University of Science and Technology, 22110 Irbid, Jordan.'}, {'ForeName': 'Yousef S', 'Initials': 'YS', 'LastName': 'Khader', 'Affiliation': 'Department of Community Medicine and Public Health, Faculty of Medicine, Jordan University of Science and Technology, 22110 Irbid, Jordan.'}, {'ForeName': 'Mahmoud A', 'Initials': 'MA', 'LastName': 'Alfaqih', 'Affiliation': 'Department of Physiology and Biochemistry, Faculty of Medicine, Jordan University of Science and Technology, 22110 Irbid, Jordan.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Saadeh', 'Affiliation': 'Department of Community Medicine and Public Health, Faculty of Medicine, Jordan University of Science and Technology, 22110 Irbid, Jordan.'}, {'ForeName': 'Lora', 'Initials': 'L', 'LastName': 'Al Sawalha', 'Affiliation': 'Anti-Microbial-Resistance Officer, World Health Organization, Jordan Country Office, 11181 Amman, Jordan.'}]","Antibiotics (Basel, Switzerland)",['10.3390/antibiotics9080507']
2302,32806826,Cost-Effectiveness of Individual versus Group Psychotherapy for Sexually Abused Girls.,"BACKGROUND


Children who have been sexually abused may suffer from emotional and behavioural difficulties. Recent research found that individual and group psychotherapy have similar outcomes. In this study we compare the costs and cost-effectiveness of the two therapies and support for carers.
METHODS


Subjects were recruited to two clinics in London and randomly allocated to the two treatments. The different components of each intervention were identified and costed.
RESULTS


Total mean costs of individual therapy were found to be £1246 greater than for group therapy. Costs as they would apply in routine practice were relatively unchanged. Group therapy was thus more cost-effective than individual therapy.
DISCUSSION


Carefully considering the impact of different therapies could allow more treatment to be offered from available staff resources and budgets. However, this is a single small study and further work is required to strengthen the evidence-base before change in practice is readily undertaken.",2005,"RESULTS


Total mean costs of individual therapy were found to be £1246 greater than for group therapy.","['Sexually Abused Girls', 'Children who have been sexually abused may suffer from emotional and behavioural difficulties', 'Subjects were recruited to two clinics in London']",['Individual versus Group Psychotherapy'],"['Total mean costs of individual therapy', 'costs and cost-effectiveness', 'Cost-Effectiveness', 'cost-effective']","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0204525', 'cui_str': 'Individual psychotherapy'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0272692,"RESULTS


Total mean costs of individual therapy were found to be £1246 greater than for group therapy.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'McCrone', 'Affiliation': 'Centre for the Economics of Mental Health, Box P024, Health Services Research Department, Institute of Psychiatry, De Crespigny Park, London SE5 8AF, UK. E-mail: p.mccrone@iop.kcl.ac.uk.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Weeramanthri', 'Affiliation': 'Camberwell Child and Adolescent Service, South London and Maudsley NHS Trust.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Knapp', 'Affiliation': 'Centre for the Economics of Mental Health, Box P024, Health Services Research Department, Institute of Psychiatry, De Crespigny Park, London SE5 8AF, UK. E-mail: p.mccrone@iop.kcl.ac.uk.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Rushton', 'Affiliation': ""Section of Social Work and Social Care, Institute of Psychiatry, King's College, London.""}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Trowell', 'Affiliation': 'Child and Family Department, Tavistock and Portman NHS Trust, London.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Miles', 'Affiliation': 'Child and Family Department, Tavistock and Portman NHS Trust, London.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Kolvin', 'Affiliation': 'Child and Family Department, Tavistock and Portman NHS Trust, London.'}]",Child and adolescent mental health,['10.1111/j.1475-3588.2005.00113.x']
2303,32806876,Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis.,"Background/Aims


A subgroup analysis was conducted in Japanese patients with moderate to severe ulcerative colitis (UC) enrolled in the phase 3 VISIBLE 1 study, which evaluated the safety and efficacy of a new vedolizumab subcutaneous (SC) formulation.
Methods


Eligible patients received open-label infusions of vedolizumab 300 mg intravenous (IV) at weeks 0 and 2 in the induction phase. Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase and were randomized to vedolizumab 108 mg SC every 2 weeks, placebo, or vedolizumab 300 mg IV every 8 weeks. The primary endpoint was clinical remission (complete Mayo score ≤ 2 points; no individual subscore > 1 point) at week 52.
Results


Of 49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6 and were randomized to vedolizumab 108 mg SC (n = 10), placebo (n = 10), or vedolizumab 300 mg IV (n = 2). At week 52, 4 out of 10 patients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (difference: 20% [95% confidence interval, -27.9 to 61.8]). Two patients (2/10, 20%) who received vedolizumab SC experienced an injection-site reaction versus none who received placebo.
Conclusions


Our results indicate that the efficacy of vedolizumab SC in a subgroup of Japanese patients with UC are similar with those in the overall VISIBLE 1 study population, and with those established with vedolizumab IV. The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV. (ClinicalTrials.gov ID NCT02611830; EudraCT 2015-000480-14).",2020,The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV.,"['Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase', '49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6', 'Japanese patients with moderately to severely active ulcerative colitis', 'Japanese patients with moderate to severe ulcerative colitis (UC', 'Japanese patients with UC']","['vedolizumab SC', 'vedolizumab', 'vedolizumab 108 mg SC', 'open-label infusions of vedolizumab', 'vedolizumab subcutaneous (SC) formulation', 'vedolizumab subcutaneous formulation', 'placebo, or vedolizumab', 'placebo']","['clinical remission (complete Mayo score', 'clinical remission', 'Efficacy and safety', 'safety and tolerability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C2742797', 'cui_str': 'vedolizumab'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",49.0,0.341281,The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV.,"[{'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Infusion clinic, Osaka, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Ashida', 'Affiliation': 'Inflammatory Bowel Disease Center, Sapporo Tokushukai Hospital, Sapporo, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Yokoyama', 'Affiliation': 'Yokoyama IBD Clinic, Nagoya, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Nagahori', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokyo Dental Medical University Hospital, Tokyo, Japan.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Inaba', 'Affiliation': 'Department of Gastroenterology, Kagawa Prefectural Central Hospital, Kagawa, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Shikamura', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Tetsuharu', 'Initials': 'T', 'LastName': 'Hori', 'Affiliation': 'Takeda Development Center Japan, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Pinton', 'Affiliation': 'Japan Medical Office, Takeda Pharmaceutical Company Limited, Tokyo, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tokyo Dental Medical University Hospital, Tokyo, Japan.'}, {'ForeName': 'Toshifumi', 'Initials': 'T', 'LastName': 'Hibi', 'Affiliation': 'Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.'}]",Intestinal research,['10.5217/ir.2020.00026']
2304,32806953,Effect of calcitonin gene-related peptide (-receptor) antibodies in chronic cluster headache: Results from a retrospective case series support individual treatment attempts.,"OBJECTIVE


To assess the efficacy of monoclonal antibodies targeting calcitonin gene-related peptide (CGRP) or its receptor in chronic cluster headache (CCH) treatment under real world conditions.
BACKGROUND


Calcitonin gene-related peptide has an important pathophysiological role in cluster headache. Although the randomised controlled trial with the calcitonin gene-related peptide antibody galcanezumab was negative, chronic cluster headache patients with insufficient response to other preventive treatments have been receiving individual off-label treatment attempts with calcitonin gene-related peptide-(receptor) antibodies.
METHODS


Data from 22 chronic cluster headache patients who received at least one dose of a calcitonin gene-related peptide(-receptor) antibody and recorded attack frequency in a headache diary were retrospectively collected at eight headache centres.
RESULTS


The number of previous preventive therapies was 6.5 ± 2.4 (mean ± standard deviation, range: 2-11). The average number of attacks per week was 23.3 ± 16.4 at baseline and significantly decreased by -9.2 ± 9.7 in the first month of treatment with a calcitonin gene-related peptide(-receptor) antibody ( p  < 0.001). Fifty-five percent of the patients were 50% responders and 36% were 75% responders with respect to attack frequency. Significant reduction of attack frequency started at week 1 (-6.8 ± 2.8 attacks,  p  < 0.01). Results were corroborated by significant decreases in weekly uses of acute headache medication (-9.8 ± 7.6,  p  < 0.001) and pain intensity during attacks (-1.2 ± 2.0, numerical rating scale (NRS) [0-10],  p  < 0.01) in the first month. In months 2 (n = 14) and 3 (n = 10), reduction of attack frequency from baseline was -8.0 ± 8.4 ( p  = 0.004) and -9.1 ± 10.0 ( p  = 0.024), respectively.
CONCLUSION


Under real-world conditions, individual treatment with calcitonin gene-related peptide(-receptor) antibodies was effective in 55% of our chronic cluster headache patients. This finding supports individual off-label treatment attempts with calcitonin gene-related peptide-(receptor) antibodies in chronic cluster headache patients insufficiently responding to other therapies.",2020,"Significant reduction of attack frequency started at week 1 (-6.8 ± 2.8 attacks,  p  < 0.01).","['chronic cluster headache patients', '22 chronic cluster headache patients who received at least one dose of a calcitonin gene-related peptide(-receptor) antibody and recorded attack frequency in a headache diary were retrospectively collected at eight headache centres', 'chronic cluster headache']","['monoclonal antibodies targeting calcitonin gene-related peptide (CGRP', 'calcitonin gene-related peptide (-receptor) antibodies', 'calcitonin gene-related peptide antibody galcanezumab']","['attack frequency started', 'pain intensity during attacks', 'acute headache medication', 'numerical rating scale (NRS', 'reduction of attack frequency', 'average number of attacks']","[{'cui': 'C0009088', 'cui_str': 'Cluster headache'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1096117', 'cui_str': 'Off label use'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1096117', 'cui_str': 'Off label use'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C4694273', 'cui_str': 'galcanezumab'}]","[{'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0744633', 'cui_str': 'Acute headache'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",22.0,0.0207218,"Significant reduction of attack frequency started at week 1 (-6.8 ± 2.8 attacks,  p  < 0.01).","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Ruscheweyh', 'Affiliation': 'Ludwig Maximilians University Munich, Department of Neurology, Munich, Germany.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Broessner', 'Affiliation': 'Headache Outpatient Clinic, Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Goßrau', 'Affiliation': 'Headache Outpatient Clinic, Interdisciplinary Pain Center, University Hospital and Faculty of Medicine Carl Gustav Carus, TU Dresden, Dresden, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Heinze-Kuhn', 'Affiliation': 'Migraine and Headache Centre, Pain Clinic Kiel, Kiel, Germany.'}, {'ForeName': 'Tim P', 'Initials': 'TP', 'LastName': 'Jürgens', 'Affiliation': 'Headache Center North-East, Department of Neurology, University Medical Center Rostock, Rostock, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kaltseis', 'Affiliation': 'Headache Outpatient Clinic, Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kamm', 'Affiliation': 'Ludwig Maximilians University Munich, Department of Neurology, Munich, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Peikert', 'Affiliation': 'Neurologicum Bremen Outpatient Center for Neurology and Psychiatry, Bremen, Germany.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Raffaelli', 'Affiliation': 'Charité Universitätsmedizin Berlin, Department of Neurology, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Rimmele', 'Affiliation': 'Headache Center North-East, Department of Neurology, University Medical Center Rostock, Rostock, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Evers', 'Affiliation': 'Department of Neurology, Krankenhaus Lindenbrunn, Coppenbrügge, Germany.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420949866']
2305,32800482,Five years' experience of double faced tubularized preputial flap for penoscrotal hypospadias repair in pediatrics.,"BACKGROUND


The success of techniques for proximal hypospadias repair using vascularized preputial flaps has led to their wide application for the last decade. From these techniques, transverse tubularized preputial flaps are particularly attractive. However, high reported rate of complications, including recurrence and urethro-cutaneous fistulae are still challenging the success of these techniques, probably related to vascular insufficiency for the lengthy neourethra. Therefore, many surgeons trying to improve the outcome by utilizing the unique vascular benefits of double faced preputial flap.
AIM OF THE WORK


the present study tries"" to evaluate double faced tubularized preputial flap technique for incidence of complications, in comparison with the standard ventral tubularized preputial flap, and to evaluate also surgical outcomes regarding the clinical urinary function and cosmetic results.
PATIENT AND METHODS


This was a prospective controlled randomized study, included 160 patients with peno-scrotal hypospadias, conducted at Al-Azhar University hospitals, from January 2014 to January 2019. All patients submitted to one-stage repair. Eighty patients underwent double faced tubularized preputial flap technique (group A) and 80 patients underwent standard ventral preputial tubularized flap technique (group B).
RESULTS


Different complications were reported in 12 patients (15%) in group A, compared to 20 patients (25%) in group B. The difference between the complication rates in both groups was statistically significant. 152 of 160 children (95%) had good clinical urinary functional outcomes (short micturition time, good urinary stream without straining or post voiding dribbling) and satisfactory cosmetic results obtained by parents' questioner at follow up visits.
DISCUSSION


This article presents an evaluation of double faced tubularized preputial flap technique in comparison to standard ventral preputial tubularized flap technique (Duckett) in one-stage peno-scrotal hypospadias repair, regarding surgical outcomes, rate of complications, clinical urinary function and satisfactory cosmetic results. Double faced tubularized flap repair is a good option to reconstruct penoscrotal hypospadias after correction of chordee which have fewer complications and also shows that transferring the tube with its skin appears to achieve better ventral skin covering.
CONCLUSION


Double faced tubularized preputial flap technique seems to be a superior option, that provide better vascular supply with better results when compared to standard ventral preputial tubularized flap in one-stage peno-scrotal hypospadias repair, with reported fewer complications, better urinary function and good cosmetic results.",2020,The difference between the complication rates in both groups was statistically significant.,"['152 of 160 children (95%) had', 'Eighty patients underwent', ""Five years' experience of double faced tubularized preputial flap for penoscrotal hypospadias repair in pediatrics"", '160 patients with peno-scrotal hypospadias, conducted at Al-Azhar University hospitals, from January 2014 to January 2019']","['standard ventral preputial tubularized flap technique (group B', 'double faced tubularized preputial flap technique', 'standard ventral preputial tubularized flap technique (Duckett']","['good clinical urinary functional outcomes (short micturition time, good urinary stream without straining or post voiding dribbling) and satisfactory cosmetic', 'complication rates']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0452147', 'cui_str': 'Hypospadias, penoscrotal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C2197691', 'cui_str': 'Scrotal hypospadias'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",160.0,0.0603302,The difference between the complication rates in both groups was statistically significant.,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Daboos', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University, Al-Houssain University Hospital, Darrasa, Cairo, Egypt. Electronic address: daboosmohammad@gmail.com.'}, {'ForeName': 'Ahmed Abdelghaffar', 'Initials': 'AA', 'LastName': 'Helal', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University, Al-Houssain University Hospital, Darrasa, Cairo, Egypt. Electronic address: helalhmada@yahoo.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Salama', 'Affiliation': 'Pediatric Surgery Department, Al-Azhar University, Al-Houssain University Hospital, Darrasa, Cairo, Egypt. Electronic address: dr_salama1982@yahoo.com.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.07.037']
2306,32680779,Prognostic implications of coronary physiological indices in patients with diabetes mellitus.,"INTRODUCTION AND OBJECTIVES


Has been performed of the prognostic value of coronary physiological indices in patients with diabetes mellitus (DM) after coronary revascularization deferral.
METHODS


We analyzed 714 patients (235 with DM) with deferred revascularization according to fractional flow reserve (> 0.80). A comprehensive physiological evaluation including coronary flow reserve (CFR), index of microcirculatory resistance, and fractional flow reserve was performed at the time of revascularization deferral. The median values of the CFR (2.88), fractional flow reserve (0.88), and index of microcirculatory resistance (17.85) were used to classify patients into high- or low-index groups. The primary outcome was the patient-oriented composite outcome (POCO) at 5 years, comprising all-cause death, any myocardial infarction, and any revascularization.
RESULTS


Compared with the non-DM population, the DM population showed higher risk of POCO (HR, 2.49; 95%CI, 1.64-3.78; P<.001). In the DM population, the low-CFR group had a higher risk of POCO than the high-CFR group (HR, 3.22; 95%CI, 1.74-5.97; P <.001). In contrast, CFR values could not differentiate the risk of POCO in the non-DM population. There was a significant interaction between CFR and the presence of DM regarding the risk of POCO (P for interaction=.025). Independent predictors of POCO were a low CFR and family history of coronary artery disease in the DM population and percent diameter stenosis and multivessel disease in the non-DM population.
CONCLUSIONS


The association between coronary physiological indices and clinical outcomes differs according to the presence of DM. In deferred patients, CFR is the most important prognostic factor in patients with DM, but not in those without DM.",2020,"Compared with the non-DM population, the DM population showed higher risk of POCO (HR, 2.49; 95%CI, 1.64-3.78; P<.001).","['patients with diabetes mellitus', '714 patients (235 with DM) with deferred revascularization according to fractional flow reserve (> 0.80', 'patients with diabetes mellitus (DM) after coronary revascularization deferral']",[],"['coronary flow reserve (CFR), index of microcirculatory resistance, and fractional flow reserve', 'risk of POCO', 'patient-oriented composite outcome (POCO) at 5 years, comprising all-cause death, any myocardial infarction, and any revascularization', 'median values of the CFR (2.88), fractional flow reserve (0.88), and index of microcirculatory resistance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]",[],"[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4517484', 'cui_str': '0.88'}]",714.0,0.105897,"Compared with the non-DM population, the DM population showed higher risk of POCO (HR, 2.49; 95%CI, 1.64-3.78; P<.001).","[{'ForeName': 'Doyeon', 'Initials': 'D', 'LastName': 'Hwang', 'Affiliation': 'Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jinlong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Joo Myung', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joon-Hyung', 'Initials': 'JH', 'LastName': 'Doh', 'Affiliation': 'Department of Medicine, Inje University Ilsan Paik Hospital, Goyang, South Korea.'}, {'ForeName': 'Chang-Wook', 'Initials': 'CW', 'LastName': 'Nam', 'Affiliation': 'Department of Medicine, Keimyung University Dongsan Medical Center, Daegu, South Korea.'}, {'ForeName': 'Eun-Seok', 'Initials': 'ES', 'LastName': 'Shin', 'Affiliation': 'Division of Cardiology, Ulsan Hospital, Ulsan, South Korea and Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Hoshino', 'Affiliation': 'Division of Cardiovascular Medicine, Tsuchiura Kyodo General Hospital, Ibaraki, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Murai', 'Affiliation': 'Division of Cardiovascular Medicine, Tsuchiura Kyodo General Hospital, Ibaraki, Japan.'}, {'ForeName': 'Taishi', 'Initials': 'T', 'LastName': 'Yonetsu', 'Affiliation': 'Department of Cardiovascular Medicine, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Hernán', 'Initials': 'H', 'LastName': 'Mejía-Rentería', 'Affiliation': 'Instituto Cardiovascular, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Tsunekazu', 'Initials': 'T', 'LastName': 'Kakuta', 'Affiliation': 'Division of Cardiovascular Medicine, Tsuchiura Kyodo General Hospital, Ibaraki, Japan.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Instituto Cardiovascular, Hospital Clínico San Carlos, Madrid, Spain; Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain.'}, {'ForeName': 'Bon-Kwon', 'Initials': 'BK', 'LastName': 'Koo', 'Affiliation': 'Department of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, South Korea; Institute of Aging, Seoul National University, Seoul, Korea. Electronic address: bkkoo@snu.ac.kr.'}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2020.06.007']
2307,32800613,Re: Prajna et al.: Cross-Linking-Assisted Infection Reduction: a randomized clinical trial evaluating the effect of adjuvant cross-linking on outcomes in fungal keratitis (Ophthalmology. 2020;127:159-166).,,2020,,['fungal keratitis (Ophthalmology'],"[' Cross-Linking-Assisted Infection Reduction', 'adjuvant cross-linking']",[],"[{'cui': 'C1262117', 'cui_str': 'Fungal keratitis'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}]","[{'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]",[],,0.139189,,"[{'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Hafezi', 'Affiliation': 'Laboratory for Ocular Cell Biology, Center for Applied Biotechnology and Molecular Medicine, University of Zurich, Switzerland; ELZA Institute, Dietikon, Switzerland; USC Roski Eye Institute, University of Southern California, Los Angeles, California; Faculty of Medicine, University of Geneva, Geneva, Switzerland; Department of Ophthalmology, University of Wenzhou, Wenzhou, China. Electronic address: farhad@hafezi.ch.'}, {'ForeName': 'Emilio A', 'Initials': 'EA', 'LastName': 'Torres-Netto', 'Affiliation': 'Laboratory for Ocular Cell Biology, Center for Applied Biotechnology and Molecular Medicine, University of Zurich, Switzerland; ELZA Institute, Dietikon, Switzerland; Department of Ophthalmology, Paulista School of Medicine, Federal University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Mark J P', 'Initials': 'MJP', 'LastName': 'Hillen', 'Affiliation': 'ELZA Institute, Dietikon, Switzerland.'}]",Ophthalmology,['10.1016/j.ophtha.2020.07.011']
2308,32800642,"Impact of Extremity Manipulation on Postural Sway Characteristics: A Preliminary, Randomized Crossover Study.","OBJECTIVE


Evaluate multisegmental postural sway after upper- vs lower-extremity manipulation.
METHODS


Participants were healthy volunteers (aged 21-40 years). Upper- or lower-extremity manipulations were delivered in a randomized crossover design. Postural assessments were made pre-post manipulation, in floor and rocker board conditions. Analysis included traditional balance measures of pathlength and range and sample entropy (SampEn) to examine the temporal structure of sway of the head, trunk, and surface.
RESULTS


No statistical changes in pathlength or sway range on the ground surface condition were observed. No increases in the amount of sway occurred in any condition. Chiropractic manipulation of either upper or lower extremities led to reductions in traditional measures of postural control on the rocker board. In the anteroposterior direction (sagittal plane), lower-extremity manipulation led to increased trunk SampEn while on the ground, and conversely a decreased SampEn while on the rocker board. In the mediolateral rocker board condition (frontal plane), manipulation elicited a change in SampEn that differed according to site of manipulation; upper-extremity manipulation increased SampEn, whereas lower-extremity manipulation reduced SampEn.
CONCLUSION


Both upper- and lower-extremity manipulation influenced several measures of postural sway on both the ground and the rocker board. Lower-extremity manipulation improved the organization of sway at the trunk (anteroposterior direction) and the board (mediolateral direction). Given the reduction and reorganization of sway metrics seen in this study, we propose extending this line of research to the elderly who are at greatest risk of increased sway and falls.",2020,Both upper- and lower-extremity manipulation influenced several measures of postural sway on both the ground and the rocker board.,['Participants were healthy volunteers (aged 21-40 years'],"['Upper- or lower-extremity manipulations', 'Extremity Manipulation']","['Postural Sway Characteristics', 'multisegmental postural sway', 'amount of sway', 'pathlength or sway range', 'traditional balance measures of pathlength and range and sample entropy (SampEn) to examine the temporal structure of sway of the head, trunk, and surface']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}]","[{'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0376522', 'cui_str': 'Entropy'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",,0.0207332,Both upper- and lower-extremity manipulation influenced several measures of postural sway on both the ground and the rocker board.,"[{'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Malaya', 'Affiliation': 'Center for Neuromotor and Biomechanics Research, University of Houston, Houston, Texas and Research Center, Parker University, Dallas, Texas.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Haworth', 'Affiliation': 'Department of Human Movement Science, Oakland University, Rochester, Michigan.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Pohlman', 'Affiliation': 'Research Center, Parker University, Dallas, Texas.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Powell', 'Affiliation': 'College of Chiropractic, Parker University, Nashoba, Oklahoma.'}, {'ForeName': 'Dean L', 'Initials': 'DL', 'LastName': 'Smith', 'Affiliation': 'Department of Kinesiology and Health, Miami University, Oxford, Ohio and Essence of Wellness Chiropractic Center, Eaton, Ohio. Electronic address: smithdL2@miamioh.edu.'}]",Journal of manipulative and physiological therapeutics,['10.1016/j.jmpt.2019.02.014']
2309,32800653,Study of the gastrointestinal bioavailability of a pancreatic extract product (Zenpep) in chronic pancreatitis patients with exocrine pancreatic insufficiency.,"INTRODUCTION


The Food and Drug Administration in 2006 required that all pancreatic enzyme products demonstrate bioavailability of lipase, amylase, and protease in the proximal small intestine.
METHODS


In this phase I open-label, randomized, crossover trial, 17 adult chronic pancreatitis (CP) patients with severe exocrine pancreatic insufficiency (EPI) underwent two separate gastroduodenal perfusion procedures (Dreiling tube suctioning and [ 14 C]-PEG instillation by an attached Dobhoff tube in the duodenal bulb). Patients received Ensure Plus® alone and Ensure Plus with Zenpep (75,000 USP lipase units) in random order. The bioavailability of Zenpep was estimated by comparing the recovery of lipase, amylase, chymotrypsin activity in two treatment conditions.  14 C-PEG was used to correct duodenal aspirates volume. The primary efficacy endpoint was lipase delivery in the duodenum after Zenpep administration under fed conditions. Secondary efficacy endpoints included chymotrypsin and amylase delivery, serum CCK levels, and measuring duodenal and gastric pH.
RESULTS


Zenpep administration with a test meal was associated with significant increase in duodenal aspiration of lipase (p = 0.046), chymotrypsin (p = 0.008), and amylase (p = 0.001), compared to the test meal alone, indicating release of enzymes to the duodenum. Lipase delivery was higher in the pH subpopulation (the efficacy population with acid hypersecretors excluded) (p = 0.01). Recovery of [ 14 C]-PEG was 61%. Zenpep was generally well tolerated. All adverse events were mild and transient.
CONCLUSIONS


In CP patients with severe EPI, lipase, chymotrypsin and amylase were released rapidly into the duodenum after ingestion of Zenpep plus meal compared to meals alone. Results also reflected the known pH threshold for enzyme release from enteric coated products.",2020,"The bioavailability of Zenpep was estimated by comparing the recovery of lipase, amylase, chymotrypsin activity in two treatment conditions.  ","['chronic pancreatitis patients with exocrine pancreatic insufficiency', '17 adult chronic pancreatitis (CP) patients with severe exocrine pancreatic insufficiency (EPI) underwent two']","['separate gastroduodenal perfusion procedures (Dreiling tube suctioning and [ 14 C]-PEG instillation by an attached Dobhoff tube in the duodenal bulb', 'pancreatic extract product (Zenpep', 'Plus® alone and Ensure Plus with Zenpep (75,000 USP lipase units']","['tolerated', 'bioavailability of lipase, amylase, and protease in the proximal small intestine', 'bioavailability of Zenpep', 'chymotrypsin and amylase delivery, serum CCK levels, and measuring duodenal and gastric pH', 'lipase delivery in the duodenum', 'recovery of lipase, amylase, chymotrypsin activity', 'Lipase delivery', 'duodenal aspiration of lipase']","[{'cui': 'C0149521', 'cui_str': 'Chronic pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267963', 'cui_str': 'Exocrine pancreatic insufficiency'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0450199', 'cui_str': 'Gastroduodenal'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0302945', 'cui_str': 'Carbon-14'}, {'cui': 'C0032478', 'cui_str': 'Polyethylene Glycol 400'}, {'cui': 'C0184959', 'cui_str': 'Instillation'}, {'cui': 'C3204189', 'cui_str': 'Nasoduodenal feeding tube'}, {'cui': 'C0227300', 'cui_str': 'Duodenal ampulla structure'}, {'cui': 'C0030289', 'cui_str': 'Pancreatic Extract'}, {'cui': 'C2725181', 'cui_str': 'Zenpep'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0059375', 'cui_str': 'Ensure Plus'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0023764', 'cui_str': 'Lipase'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0030940', 'cui_str': 'Peptide Hydrolases'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C2725181', 'cui_str': 'Zenpep'}, {'cui': 'C0008742', 'cui_str': 'CHYMOTRYPSIN'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0008328', 'cui_str': 'Cholecystokinin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C1168023', 'cui_str': 'Gastric pH'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}]",17.0,0.0186206,"The bioavailability of Zenpep was estimated by comparing the recovery of lipase, amylase, chymotrypsin activity in two treatment conditions.  ","[{'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Lieb', 'Affiliation': 'Section of Gastroenterology, University of Florida, 1549 Gale Lemerand Drive, Gainesville, FL, 32610-3008, USA. Electronic address: John.Lieb@medicine.ufl.edu.'}, {'ForeName': 'Dhruvan', 'Initials': 'D', 'LastName': 'Patel', 'Affiliation': 'Section of Gastroenterology, University of Pennsylvania, 3400 Civic Center Blvd, 7th Floor, Philadelphia, PA, 19104, USA. Electronic address: pateldhruvan@gmail.com.'}, {'ForeName': 'Nihaal', 'Initials': 'N', 'LastName': 'Karnik', 'Affiliation': 'Department of Internal Medicine, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA, 19104, USA. Electronic address: npkarnik@gmail.com.'}, {'ForeName': 'Phillip P', 'Initials': 'PP', 'LastName': 'Toskes', 'Affiliation': 'Section of Gastroenterology, University of Florida, 1549 Gale Lemerand Drive, Gainesville, FL, 32610-3008, USA. Electronic address: Phillip.toskes@medicine.ufl.edu.'}]",Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.],['10.1016/j.pan.2020.07.007']
2310,32800712,Radiation Dose Reduction in Early-Stage Hodgkin Lymphoma.,"INTRODUCTION


Treatment for early-stage Hodgkin lymphoma (HL) involves radiotherapy (RT), chemotherapy, or combined modality therapy (CMT). We analyzed reduction of RT dose in CMT, particularly in the context of German Hodgkin Study Group (GHSG) HD10 randomized trial results of 2010.
PATIENTS AND METHODS


The National Cancer Data Base was queried for patients with stage I-II HL receiving CMT. RT dose and associated characteristics were analyzed. Stage I and absence of B symptoms were used as a surrogate for early-stage favorable disease.
RESULTS


Of 31,301 patients with stage I-II HL, 11,457 received CMT between 2004 and 2015. Using the surrogate defined above, 1955 patients (17.1%) were classified as having favorable disease. The majority (61.6%) received 30-36 Gy, while 7.0% received 20 Gy. The provision of 20 Gy was more common in stage I patients (12.3% vs. 5.4% in stage II) and at academic facilities (10.8% vs. 6.3%-8.9% at other facilities). Use of 20 Gy (vs. 30-36 Gy) was less likely with thorax site (odds ratio [OR] 0.43 vs. head and neck), stage II disease (OR 0.41), and B symptoms (OR 0.33). Notably, the use of 20 Gy increased dramatically after 2010 (the year of publication of GHSG HD10 trial results), with rates of 12.3% in 2010-2015 versus 0.1% in 2004-2009 (OR 6.3, P < .001). This was even more pronounced in cases of favorable early-stage disease, with 25.5% after 2010 versus 2.8% before 2010 (OR 13.2, P < .001). The use of doses > 36 Gy decreased over a corresponding time period (OR 0.44, P < .001).
CONCLUSION


Analysis of CMT for patients with early-stage HL demonstrates variability in RT dose, including increasing use of 20 Gy and decreasing use of high doses > 36 Gy.",2020,"The use of doses > 36 Gy decreased over a corresponding time period (OR 0.44, P < .001).
","['31,301 patients with stage I-II HL', 'Early-Stage Hodgkin Lymphoma']","['radiotherapy (RT), chemotherapy, or combined modality therapy (CMT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0019829', 'cui_str': 'Hodgkin lymphoma'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]",[],31301.0,0.0726155,"The use of doses > 36 Gy decreased over a corresponding time period (OR 0.44, P < .001).
","[{'ForeName': 'Bhartesh A', 'Initials': 'BA', 'LastName': 'Shah', 'Affiliation': 'Department of Radiation Oncology, NYU Langone Health, New York, NY.'}, {'ForeName': 'Cheongeun', 'Initials': 'C', 'LastName': 'Oh', 'Affiliation': 'Department of Population Health: Biostatistics, NYU Langone Health, New York, NY.'}, {'ForeName': 'S Peter', 'Initials': 'SP', 'LastName': 'Wu', 'Affiliation': 'Department of Radiation Oncology, NYU Langone Health, New York, NY.'}, {'ForeName': 'Jerome M', 'Initials': 'JM', 'LastName': 'Karp', 'Affiliation': 'Department of Radiation Oncology, NYU Langone Health, New York, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Grossbard', 'Affiliation': 'Department of Medical Oncology, NYU Langone Health, New York, NY.'}, {'ForeName': 'Naamit K', 'Initials': 'NK', 'LastName': 'Gerber', 'Affiliation': 'Department of Radiation Oncology, NYU Langone Health, New York, NY. Electronic address: Naamit.Gerber@nyulangone.org.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2020.07.010']
2311,32800792,Exercise intensity and cardiovascular health outcomes after 12 months of football fitness training in women treated for stage I-III breast cancer: Results from the football fitness After Breast Cancer (ABC) randomized controlled trial.,"PURPOSE


To examine the exercise intensity and impact of 12 months of twice-weekly recreational football training on cardiorespiratory fitness (CRF), blood pressure (BP), resting heart rate (HR rest ), body fat mass, blood lipids, inflammation, and health-related quality of life in women treated for early-stage breast cancer (BC).
METHODS


Sixty-eight women who had received surgery for stage I-III BC and completed adjuvant chemo- and/or radiation therapy within 5 years were randomized in a 2:1 ratio to a Football Fitness group (FFG, n = 46) or a control group (CON, n = 22). Football Fitness sessions comprised a warm-up, drills and 3-4 × 7 min of small-sided games (SSG). Assessments were performed at baseline, 6 months and 12 months. Outcomes were peak oxygen uptake (VO 2 peak), blood pressure (BP), HR rest , total body fat mass, and circulating plasma lipids and hs-CRP, and the 36-Item Short Form Health Survey (SF36). Intention-to-treat (ITT) analyses were performed using linear mixed models. Data are means with SD or 95% confidence intervals.
RESULTS


Adherence to training in participants completing the 12-months follow-up (n = 33) was 47.1% (22.7), and HR during SSG was ≥80% of HR max  for 69.8% (26.5) of total playing time. At baseline, VO 2 peak was 28.5 (6.4) and 25.6 (5.9) ml O 2 /kg/min in FFG and CON, respectively, and no significant changes were observed at 6- or 12 months follow-up. Systolic BP (SBP) was 117.1 (16.4) and 116.9 (14.8) mmHg, and diastolic BP (DBP) was 72.0 (11.2) and 72.4 (8.5) mmHg in FFG and CON, respectively, at baseline, and a 9.4 mmHg decrease in SBP in CON at 12 months resulted in a between-group difference at 12 months of 8.7 mmHg (p = .012). Blood lipids and hs-CRP were within the normal range at baseline, and there were no differences in changes between groups over the 12 months. Similarly, no differences between groups were observed in HR rest  and body fat mass at 6- and12-months follow-up. A between-group difference in mean changes of 23.5 (0.95-46.11) points in the role-physical domain of the SF36 survey favored FFG at 6 months CONCLUSION: Football Fitness training is an intense exercise form for women treated for breast cancer, and self-perceived health-related limitations on daily activities were improved after 6 months. However, 1 year of Football Fitness training comprising 1 weekly training session on average did not improve CRF, BP, blood lipids, fat mass, or HR rest .
TRIAL REGISTRATION NUMBER


The trial was registered at ClinicalTrials.gov with identifier NCT03284567.",2020,"Blood lipids and hs-CRP were within the normal range at baseline, and there were no differences in changes between groups over the 12 months.","['women treated for early-stage breast cancer (BC', 'women treated for stage I-III breast cancer', 'within 5\u202fyears', 'Sixty-eight women who had received surgery for stage I-III BC and completed adjuvant chemo']","['and/or radiation therapy', 'Football Fitness group (FFG, n\u202f=\u202f46) or a control group (CON', 'twice-weekly recreational football training', 'Football Fitness training', 'football fitness training']","['peak oxygen uptake (VO 2 peak), blood pressure (BP), HR rest , total body fat mass, and circulating plasma lipids and hs-CRP, and the 36-Item Short Form Health Survey (SF36', 'HR rest  and body fat mass', 'diastolic BP (DBP', 'Systolic BP (SBP', 'Exercise intensity and cardiovascular health outcomes', 'SBP in CON', 'CRF, BP, blood lipids, fat mass, or HR rest ', 'Blood lipids and hs-CRP', 'cardiorespiratory fitness (CRF), blood pressure (BP), resting heart rate (HR rest ), body fat mass, blood lipids, inflammation, and health-related quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0016712', 'cui_str': ""Freund's adjuvant""}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0424677', 'cui_str': 'Total body fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",68.0,0.192289,"Blood lipids and hs-CRP were within the normal range at baseline, and there were no differences in changes between groups over the 12 months.","[{'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Uth', 'Affiliation': 'University Hospitals Centre for Health Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark. Electronic address: jacob.baekmark.uth@regionh.dk.'}, {'ForeName': 'Bjørn', 'Initials': 'B', 'LastName': 'Fristrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Sørensen', 'Affiliation': 'University Hospitals Centre for Health Research, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Eva Wulff', 'Initials': 'EW', 'LastName': 'Helge', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maja Kjærgaard', 'Initials': 'MK', 'LastName': 'Christensen', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Julie Boye', 'Initials': 'JB', 'LastName': 'Kjærgaard', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Trine Kjeldgaard', 'Initials': 'TK', 'LastName': 'Møller', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Magni', 'Initials': 'M', 'LastName': 'Mohr', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Faculty of Health Sciences, University of the Faroe Islands, Tórshavn, Faroe Islands.'}, {'ForeName': 'Jørn Wulff', 'Initials': 'JW', 'LastName': 'Helge', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Niklas Rye', 'Initials': 'NR', 'LastName': 'Jørgensen', 'Affiliation': 'Department of Clinical Biochemistry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Rørth', 'Affiliation': 'Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark; Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Eva Soelberg', 'Initials': 'ES', 'LastName': 'Vadstrup', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Krustrup', 'Affiliation': 'Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense, Denmark; Department of Sport and Health Sciences, Exeter University, United Kingdom; Shanghai University of Sport, China.'}]",Progress in cardiovascular diseases,['10.1016/j.pcad.2020.08.002']
2312,32800815,Randomized Controlled Early versus Late Ventricular Intervention Study (ELVIS) in Posthemorrhagic Ventricular Dilatation: Outcome at 2 Years.,"OBJECTIVE


To compare the effect of intervention at low versus high threshold of ventriculomegaly in preterm infants with posthemorrhagic ventricular dilatation on death or severe neurodevelopmental disability.
STUDY DESIGN


Multicenter randomized controlled trial. Lumbar punctures were initiated after either a low threshold (LT, ventricular index >p97 and anterior horn width >6 mm) or high threshold (HT, ventricular index >p97 + 4 mm and anterior horn width >10 mm). The composite adverse outcome was defined as death or cerebral palsy or Bayley composite cognitive/motor scores <-2 standard deviations at 24 months corrected age.
RESULTS


Outcomes were assessed in 113/126 infants. The composite adverse outcome was seen in 20/58 (35%) infants in the LT group, and 28/55 (51%) in HT (p=0.07). LT intervention was associated with a decreased risk of an adverse outcome after correcting for gestational age, severity of intraventricular hemorrhage and cerebellar hemorrhage (adjusted odds ratio: 0.24, 95% confidence interval [CI], 0.07 to 0.87, p=0.03). Infants with a favorable outcome had a smaller fronto-occipital horn ratio (crude mean difference: -0.06, 95% CI [-0.09 to -0.03]; p<0.001) at term-equivalent age. Infants in the LT group with a ventriculo-peritoneal shunt, had cognitive and motor scores similar to those without (p=0.3 for both), whereas in the HT group those with a ventriculo-peritoneal shunt had significantly lower scores than those without a ventriculo-peritoneal shunt (P = .01 and p=0.004, respectively).
CONCLUSION


In a post-hoc analysis, earlier intervention was associated with lower odds of death or severe neurodevelopmental disability in preterm infants with progressive posthemorrhagic ventricular dilatation.",2020,"Infants with a favorable outcome had a smaller fronto-occipital horn ratio (crude mean difference: -0.06, 95% CI","['preterm infants with posthemorrhagic ventricular dilatation on death or severe neurodevelopmental disability', 'Posthemorrhagic Ventricular Dilatation', 'preterm infants with progressive posthemorrhagic ventricular dilatation']","['LT intervention', 'Late Ventricular Intervention Study (ELVIS']","['death or severe neurodevelopmental disability', 'intraventricular hemorrhage and cerebellar hemorrhage', 'cognitive and motor scores', 'risk of an adverse outcome', 'composite adverse outcome', 'death or cerebral palsy or Bayley composite cognitive/motor scores <-2 standard deviations', 'smaller fronto-occipital horn ratio']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C4552505', 'cui_str': 'PHVD'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C1096775', 'cui_str': 'Intervention Study'}, {'cui': 'C0648185', 'cui_str': 'glutamyl-leucyl-valyl-isoleucyl-serine'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0149854', 'cui_str': 'Cerebellar hemorrhage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0152282', 'cui_str': 'Structure of posterior horn of lateral ventricle'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.200645,"Infants with a favorable outcome had a smaller fronto-occipital horn ratio (crude mean difference: -0.06, 95% CI","[{'ForeName': 'Mehmet N', 'Initials': 'MN', 'LastName': 'Cizmeci', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands; University Medical Center Utrecht, Utrecht Brain Center, The Netherlands; Division of Neonatology, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Floris', 'Initials': 'F', 'LastName': 'Groenendaal', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands; University Medical Center Utrecht, Utrecht Brain Center, The Netherlands.""}, {'ForeName': 'Kian D', 'Initials': 'KD', 'LastName': 'Liem', 'Affiliation': ""Department of Neonatology, Amalia Children's Hospital, Radboud University Medical Center, Nijmegen, The Netherlands.""}, {'ForeName': 'Ingrid C', 'Initials': 'IC', 'LastName': 'van Haastert', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands; University Medical Center Utrecht, Utrecht Brain Center, The Netherlands.""}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Benavente-Fernández', 'Affiliation': ""Department of Neonatology, 'Puerta del Mar' University Hospital, Cadiz, Spain.""}, {'ForeName': 'Henrica L M', 'Initials': 'HLM', 'LastName': 'van Straaten', 'Affiliation': ""Department of Neonatology, Isala Women and Children's Hospital, Zwolle, The Netherlands.""}, {'ForeName': 'Sylke', 'Initials': 'S', 'LastName': 'Steggerda', 'Affiliation': 'Department of Neonatology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Bert J', 'Initials': 'BJ', 'LastName': 'Smit', 'Affiliation': 'Directorate Quality & Patient Care, Erasmus MC, University Medical Center Rotterdam, The Netherlands.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Whitelaw', 'Affiliation': 'Department of Neonatology, Southmead Hospital, School of Clinical Science, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Woerdeman', 'Affiliation': 'Division of Neuroscience, Department of Neurosurgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Heep', 'Affiliation': 'Department of Neonatology, Southmead Hospital, School of Clinical Science, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'de Vries', 'Affiliation': ""Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands; University Medical Center Utrecht, Utrecht Brain Center, The Netherlands. Electronic address: l.s.devries@umcutrecht.nl.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.08.014']
2313,32800818,Survivors of intensive care with type 2 diabetes and the effect of shared care follow-up clinics: the SWEET-AS randomized controlled pilot study.,"BACKGROUND


Follow-up clinics after Intensive Care Unit (ICU) admission have demonstrated limited benefit. However, existing trials have evaluated heterogeneous cohorts and utilized physicians who had limited training in outpatient care.
RESEARCH QUESTION


What are the effects of a 'shared-care' intensivist-endocrinologist clinic for ICU survivors with type 2 diabetes on process measures and clinical outcomes at 6 months after hospital discharge and is it feasible to conduct a larger trial?
STUDY DESIGN


and Methods: This was a prospective, randomized, single-centre pilot study with blinded outcome assessment. Patients with type 2 diabetes, who required ≥ 5 days of ICU care (mixed medical-surgical ICU) and survived to ICU discharge were eligible. Participants were randomized to attendance at the shared-care clinic one month after hospital discharge or usual care. Six months after hospital discharge, participants were assessed for outcomes including glycated hemoglobin, neuropathy, nephropathy, quality of life (QoL), return to employment, frailty and healthcare utilization. The primary outcome was participant recruitment and retention.
RESULTS


During an 18-month period, 42 of 82 (51%) eligible patients were recruited. Four participants (10%) withdrew before assessment at 6 months and 11 (26%) died. At 6 months, only 18 (47%) of 38 participants who did not withdraw were living independently without supports and 24 (63%) required at least one subsequent hospital admission. In the intervention group (n=21), 16 (76%) attended the clinic. Point estimates did not indicate that the intervention improved glycated hemoglobin [+5.6 mmol/mol, 95% CI -6.3 to 17; P=0.36] or QoL [Short Form-36 physical summary score 32 (9) vs. 32 (7); P=1.0].
INTERPRETATION


Outcomes for ICU survivors with type 2 diabetes are poor. Due to low participation and high mortality, a larger trial of a shared-care follow-up clinic in this cohort using the present design does not appear feasible.",2020,"Point estimates did not indicate that the intervention improved glycated hemoglobin [+5.6 mmol/mol, 95% CI -6.3 to 17; P=0.36] or QoL [Short Form-36 physical summary score 32 (9) vs. 32 (7); P=1.0].
","['and Methods', 'Participants were randomized to attendance at the shared-care clinic one month after hospital discharge or usual care', '42 of 82 (51%) eligible patients were recruited', 'Survivors of intensive care with type 2 diabetes', 'Patients with type 2 diabetes, who required ≥ 5 days of ICU care (mixed medical-surgical ICU) and survived to ICU discharge were eligible']",[],"['participant recruitment and retention', 'glycated hemoglobin', 'glycated hemoglobin, neuropathy, nephropathy, quality of life (QoL), return to employment, frailty and healthcare utilization']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1690590', 'cui_str': 'Surgical intensive care unit'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",[],"[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.125569,"Point estimates did not indicate that the intervention improved glycated hemoglobin [+5.6 mmol/mol, 95% CI -6.3 to 17; P=0.36] or QoL [Short Form-36 physical summary score 32 (9) vs. 32 (7); P=1.0].
","[{'ForeName': 'Yasmine Ali', 'Initials': 'YA', 'LastName': 'Abdelhamid', 'Affiliation': 'Discipline of Acute Care Medicine, University of Adelaide, Adelaide, Australia; Intensive Care Unit, Royal Melbourne Hospital, Melbourne, Australia; Department of Medicine and Radiology, University of Melbourne, Melbourne, Australia. Electronic address: yasmine.aliabdelhamid@mh.org.au.'}, {'ForeName': 'Liza K', 'Initials': 'LK', 'LastName': 'Phillips', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia; Endocrine and Metabolic Service, Royal Adelaide Hospital, Adelaide, Australia; National Health and Medical Research Council Centre of Research Excellence (CRE) in the Translation of Nutritional Science into Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Mary G', 'Initials': 'MG', 'LastName': 'White', 'Affiliation': 'Discipline of Acute Care Medicine, University of Adelaide, Adelaide, Australia; Intensive Care Unit, Royal Adelaide Hospital, Adelaide, Australia.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Presneill', 'Affiliation': 'Intensive Care Unit, Royal Melbourne Hospital, Melbourne, Australia; Department of Medicine and Radiology, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Discipline of Medicine, University of Adelaide, Adelaide, Australia; Endocrine and Metabolic Service, Royal Adelaide Hospital, Adelaide, Australia; National Health and Medical Research Council Centre of Research Excellence (CRE) in the Translation of Nutritional Science into Good Health, University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Deane', 'Affiliation': 'Discipline of Acute Care Medicine, University of Adelaide, Adelaide, Australia; Intensive Care Unit, Royal Melbourne Hospital, Melbourne, Australia; Department of Medicine and Radiology, University of Melbourne, Melbourne, Australia.'}]",Chest,['10.1016/j.chest.2020.08.011']
2314,32800842,Treating Home Versus Predialysis Blood Pressure Among In-Center Hemodialysis Patients: A Pilot Randomized Trial.,"RATIONALE AND OBJECTIVE


Observational studies have reported a U-shaped association between pre-dialysis blood pressure (BP) and death. In contrast, a linear association between out-of-dialysis unit BP has been reported. Home BP may be a better target for treatment. To test the feasibility of this approach, we conducted a pilot trial of treating home vs. pre-dialysis BP in hemodialysis patients.
STUDY DESIGN


A 4-month parallel, randomized controlled trial.
SETTINGS & PARTICIPANTS


Fifty prevalent hemodialysis patients in San Francisco and Seattle. Participants were randomized using 1:1 block randomization, stratified by site.
INTERVENTIONS


Target home systolic BP (SBP) vs. pre-dialysis SBP 140-100 mmHg. Home and pre-dialysis SBPs were ascertained every 2 weeks. Dry weight and BP medications were adjusted to reach the target SBP.
OUTCOMES


Primary outcomes were feasibility, adherence, safety and tolerability.
RESULTS


Fifty out of seventy patients who were approached agreed to participate (71.4%). All enrollees completed the study except one who received a kidney transplant. In the home BP treatment group, adherence to obtaining/reporting home BP was 97.4% (and consistent over the 4 months). There was no increased frequency of high (defined as SBP>200 mmHg, 0.2% vs. 0%) or low (defined as <90 mmHg, 1.8% vs.1.2%) pre-dialysis BP readings in the home vs. pre-dialysis treatment arms, respectively. However, participants in the home BP arm had higher frequency of fatigue (32% vs. 16%).
LIMITATIONS


Small sample size.
CONCLUSIONS


This pilot trial demonstrates feasibility and high adherence to home BP measurement and treatment in hemodialysis patients. Larger trials to test long-term feasibility, efficacy and safety of home BP treatment in hemodialysis patients should be conducted.",2020,"There was no increased frequency of high (defined as SBP>200 mmHg, 0.2% vs. 0%) or low (defined as <90 mmHg, 1.8% vs.1.2%) pre-dialysis BP readings in the home vs. pre-dialysis treatment arms, respectively.","['All enrollees completed the study except one who received a kidney transplant', 'Fifty out of seventy patients who were approached agreed to participate (71.4', 'Center Hemodialysis Patients', 'Fifty prevalent hemodialysis patients in San Francisco and Seattle', 'hemodialysis patients']","['Target home systolic BP (SBP', 'Treating Home Versus Predialysis Blood Pressure', 'treating home vs. pre-dialysis BP']","['pre-dialysis BP readings', 'Dry weight and BP medications', 'frequency of fatigue', 'frequency of high', 'adherence to obtaining/reporting home BP', 'feasibility, adherence, safety and tolerability']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}]","[{'cui': 'C1264634', 'cui_str': 'Pre-dialysis'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",50.0,0.0430896,"There was no increased frequency of high (defined as SBP>200 mmHg, 0.2% vs. 0%) or low (defined as <90 mmHg, 1.8% vs.1.2%) pre-dialysis BP readings in the home vs. pre-dialysis treatment arms, respectively.","[{'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Bansal', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, University of Washington. Electronic address: nbansal@nephrology.washington.edu.'}, {'ForeName': 'David V', 'Initials': 'DV', 'LastName': 'Glidden', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco.'}, {'ForeName': 'Rajnish', 'Initials': 'R', 'LastName': 'Mehrotra', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, University of Washington.'}, {'ForeName': 'Raymond R', 'Initials': 'RR', 'LastName': 'Townsend', 'Affiliation': 'Division of Nephrology, University of Pennsylvania.'}, {'ForeName': 'Jordana', 'Initials': 'J', 'LastName': 'Cohen', 'Affiliation': 'Division of Nephrology, University of Pennsylvania.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Linke', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, University of Washington.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Palad', 'Affiliation': 'Division of Nephrology, University of California, San Francisco.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Larson', 'Affiliation': 'Division of Nephrology, Kidney Research Institute, University of Washington.'}, {'ForeName': 'Chi-Yuan', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Division of Nephrology, University of California, San Francisco.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2020.06.014']
2315,32800891,Cardiovascular Responses During and After Maximal Walking in Men and Women with Symptomatic Peripheral Artery Disease.,"BACKGROUND


Walking is recommended for patients with peripheral arterial disease (PAD). It has been shown that patients with PAD present sharper increases in blood pressure (BP) and heart rate (HR) during maximal walking when compared with healthy subjects and women with PAD present a worse physiological profile, and is possible to that women with PAD present higher cardiovascular load during and after a bout of maximal walking than men.
OBJECTIVE


To compare cardiovascular and autonomic responses during and after maximal walking between men and women with PAD and intermittent claudication (IC).
METHODS


Forty patients with PAD and IC (20 men and 20 women) underwent, in random order, two sessions: control (standing on treadmill) and exercise (maximal treadmill walking test with Gardner's protocol). During the exercise, HR and BP were measured. Before and after the sessions, cardiovascular variables (BP HR, cardiac output, peripheral vascular resistance and stroke volume) and autonomic modulation (HR and BP variabilities and baroreflex sensitivity) were assessed. Additionally, an ambulatory BP monitoring was recorded after each session.
RESULTS


Men and women presented similar maximal walking capacity. During the walking test, HR and systolic BP increased similarly in men and women. After the maximal walking, cardiovascular and autonomic responses did not differ between the genders. Additionally, post-intervention ambulatory BP parameters were also similar in men and women. Therefore, in men and women, maximal walking similarly reduced clinic systolic BP and stroke volume, and increased HR and total power of HR variability during the recovery period.
CONCLUSION


Men and women with PAD and IC present similar cardiovascular and autonomic responses during and after maximal walking.",2020,"Before and after the sessions, cardiovascular variables (BP HR, cardiac output, peripheral vascular resistance and stroke volume) and autonomic modulation (HR and BP variabilities and baroreflex sensitivity) were assessed.","['men and women with PAD and intermittent claudication (IC', 'patients with peripheral arterial disease (PAD', 'patients with PAD', 'Forty patients with PAD and IC (20 men and 20 women', 'Men and Women with Symptomatic Peripheral Artery Disease']","[""control (standing on treadmill) and exercise (maximal treadmill walking test with Gardner's protocol""]","['cardiovascular variables (BP HR, cardiac output, peripheral vascular resistance and stroke volume) and autonomic modulation (HR and BP variabilities and baroreflex sensitivity', 'blood pressure (BP) and heart rate (HR', 'HR and BP', 'ambulatory BP monitoring', 'clinic systolic BP and stroke volume, and increased HR and total power of HR variability', 'cardiovascular and autonomic responses', 'maximal walking capacity', 'maximal walking, cardiovascular and autonomic responses', 'walking test, HR and systolic BP', 'Cardiovascular Responses']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0038455', 'cui_str': 'Stroke volume'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",40.0,0.0560988,"Before and after the sessions, cardiovascular variables (BP HR, cardiac output, peripheral vascular resistance and stroke volume) and autonomic modulation (HR and BP variabilities and baroreflex sensitivity) were assessed.","[{'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Miyasato', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Felix', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Andrade-Lima', 'Affiliation': 'Federal University of Sergipe, Sergipe, Brazil.'}, {'ForeName': 'N D', 'Initials': 'ND', 'LastName': 'da Silva', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Ritti-Dias', 'Affiliation': 'Universidade Nove de Julho, São Paulo, Brazil.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Wolosker', 'Affiliation': 'University of São Paulo Medical School, São Paulo, Brazil.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cornelissen', 'Affiliation': 'Universit of Leuven, Leuven, Belgium.'}, {'ForeName': 'K F', 'Initials': 'KF', 'LastName': 'Goessler', 'Affiliation': 'Applied Physiology & Nutrition Research Group; Faculty of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'C L M', 'Initials': 'CLM', 'LastName': 'Forjaz', 'Affiliation': 'Exercise Hemodynamic Laboratory, School of Physical Education, University of São Paulo, São Paulo, Brazil.'}]",Annals of vascular surgery,['10.1016/j.avsg.2020.07.051']
2316,32800909,Impact of cognitive behavioral therapy on depression symptoms after transcatheter aortic valve replacement: A randomized controlled trial.,"BACKGROUND


Depression is a significant concern after cardiac surgery and has not been studied in patients undergoing transcatheter aortic valve replacement (TAVR). We sought to examine the prevalence of pre-procedure depression and anxiety symptoms and explore whether brief bedside cognitive behavioral therapy (CBT) could prevent post-TAVR psychological distress.
METHODS


We prospectively recruited consecutive TAVR patients and randomized them to receive brief CBT or treatment as usual (TAU) during their hospitalization. Multi-level regression techniques were used to evaluate changes by treatment arm in depression, anxiety, and quality of life from baseline to 1 month post-TAVR adjusted for sex, race, DM, CHF, MMSE, and STS score.
RESULTS


One hundred and forty six participants were randomized. The mean age was 82 years, and 43% were female. Self-reported depression and anxiety scores meeting cutoffs for clinical level distress were 24.6% and 23.2% respectively. Both TAU and CBT groups had comparable improvements in depressive symptoms at 1-month (31% reduction for TAU and 35% reduction for CBT, p = .83). Similarly, both TAU and CBT groups had comparable improvements in anxiety symptoms at 1-month (8% reduction for TAU and 11% reduction for CBT, p = .1). Quality of life scores also improved and were not significantly different between the two groups.
CONCLUSIONS


Pre-procedure depression and anxiety may be common among patients undergoing TAVR. However, TAVR patients show spontaneous improvement in depression and anxiety scores at 1-month follow up, regardless of brief CBT. Further research is needed to determine whether more tailored CBT interventions may improve psychological and medical outcomes.",2020,"Both TAU and CBT groups had comparable improvements in depressive symptoms at 1-month (31% reduction for TAU and 35% reduction for CBT, p = .83).","['The mean age was 82\u202fyears, and 43% were female', 'patients undergoing transcatheter aortic valve replacement (TAVR', 'patients undergoing TAVR', 'One hundred and forty six participants were randomized', 'depression symptoms after transcatheter aortic valve replacement']","['bedside cognitive behavioral therapy (CBT', 'TAU and CBT', 'CBT or treatment as usual (TAU', 'cognitive behavioral therapy', 'TAVR']","['Quality of life scores', 'anxiety symptoms', 'depression, anxiety, and quality of life', 'depression and anxiety scores', 'depressive symptoms', 'Self-reported depression and anxiety scores meeting cutoffs for clinical level distress']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}]",146.0,0.118211,"Both TAU and CBT groups had comparable improvements in depressive symptoms at 1-month (31% reduction for TAU and 35% reduction for CBT, p = .83).","[{'ForeName': 'Katharine S', 'Initials': 'KS', 'LastName': 'Edwards', 'Affiliation': 'Department of Medicine, Stanford University, United States of America. Electronic address: ksedwards@stanford.edu.'}, {'ForeName': 'Eric K H', 'Initials': 'EKH', 'LastName': 'Chow', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, (United States of America).'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Dao', 'Affiliation': 'Department of Medicine, Stanford University, United States of America.'}, {'ForeName': 'Derik', 'Initials': 'D', 'LastName': 'Hossepian', 'Affiliation': 'PGSP-Stanford Psy.D. Consortium, Palo Alto University, United States of America.'}, {'ForeName': 'Audrey G', 'Initials': 'AG', 'LastName': 'Johnson', 'Affiliation': 'PGSP-Stanford Psy.D. Consortium, Palo Alto University, United States of America.'}, {'ForeName': 'Manisha', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': 'Quantitative Sciences Unit, Stanford University, (United States of America).'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, Stanford University, United States of America.'}, {'ForeName': 'Anson', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Department of Cardiothoracic Surgery, Stanford University, United States of America.'}, {'ForeName': 'Alan C', 'Initials': 'AC', 'LastName': 'Yeung', 'Affiliation': 'Department of Medicine, Stanford University, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fischbein', 'Affiliation': 'Department of Cardiothoracic Surgery, Stanford University, United States of America.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Fearon', 'Affiliation': 'Department of Medicine, Stanford University, United States of America.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.08.007']
2317,32800962,The design of a randomized control trial of exoskeletal-assisted walking in the home and community on quality of life in persons with chronic spinal cord injury.,"There are more than 300,000 estimated cases of spinal cord injury (SCI) in the United States, and approximately 26,000 of these are Veterans. Immobilization from SCI results in adverse secondary medical conditions and reduced quality of life. Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care. Powered exoskeletons are a technology that offers an alternative form of limited mobility by enabling over-ground walking through an external framework for support and computer-controlled motorized hip and knee joints. Few studies have reported the safety and efficacy for use of these devices in the home and community environments, and none evaluated their impact on patient-centered outcomes through a randomized clinical trial (RCT). Absence of reported RCTs for powered exoskeletons may be due to a range of challenges, including designing, statistically powering, and conducting such a trial within an appropriate experimental framework. An RCT for the study of exoskeletal-assisted walking in the home and community environments also requires the need to address key factors such as: avoiding selection bias, participant recruitment and retention, training, and safety concerns, particularly in the home environment. These points are described here in the context of a national, multisite Department of Veterans Affairs Cooperative Studies Program-sponsored trial. The rationale and methods for the study design were focused on providing a template for future studies that use powered exoskeletons or other strategies for walking and mobility in people with immobilization due to SCI.",2020,Powered exoskeletons are a technology that offers an alternative form of limited mobility by enabling over-ground walking through an external framework for support and computer-controlled motorized hip and knee joints.,"['persons with chronic spinal cord injury', 'Veterans with SCI who have completed rehabilitation after injury and are unable to ambulate receive a wheelchair as standard of care', 'people with immobilization due to SCI']",['exoskeletal-assisted walking'],['quality of life'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",[],"[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0719972,Powered exoskeletons are a technology that offers an alternative form of limited mobility by enabling over-ground walking through an external framework for support and computer-controlled motorized hip and knee joints.,"[{'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Spungen', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America; Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America. Electronic address: Ann.Spungen@va.gov.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Bauman', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America; Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America. Electronic address: William.Bauman@va.gov.'}, {'ForeName': 'Kousick', 'Initials': 'K', 'LastName': 'Biswas', 'Affiliation': 'Cooperative Studies Program Coordinating Center, VA Maryland Health Care System, Perry Point, MD 21902, United States of America. Electronic address: Kousick.Biswas@va.gov.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'Cooperative Studies Program Coordinating Center, VA Maryland Health Care System, Perry Point, MD 21902, United States of America. Electronic address: Karen.Jones2@va.gov.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Snodgrass', 'Affiliation': 'VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM 87106, United States of America; University of New Mexico, College of Pharmacy, Albuquerque, NM 87106, United States of America. Electronic address: Amanda.Snodgrass@va.gov.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Goetz', 'Affiliation': 'Hunter Holmes McGuire VA Medical Center, Richmond, VA 23249, United States of America; Department of Physical Medicine and Rehabilitation, Virginia Commonwealth University, Richmond, VA 23298, United States of America. Electronic address: Lance.Goetz@va.gov.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gorman', 'Affiliation': 'Department of Neurology, University of Maryland School of Medicine, Baltimore, MD 21201, United States of America; VA Maryland Healthcare System, Baltimore, MD 21201, United States of America. Electronic address: Pgorman@umm.edu.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kirshblum', 'Affiliation': 'Kessler Institute for Rehabilitation, West Orange, NJ 07052, United States of America; Rutgers New Jersey Medical School, Newark, NJ 07103, United States of America; Kessler Foundation, West Orange, NJ 07052, United States of America. Electronic address: skirshblum@KESSLER-REHAB.com.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Sabharwal', 'Affiliation': 'VA Boston Health Care System, Boston, MA 02130, United States of America; Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA 02115, United States of America. Electronic address: Sunil.Sabharwal2@va.gov.'}, {'ForeName': 'Kevin T', 'Initials': 'KT', 'LastName': 'White', 'Affiliation': ""James A Haley Veterans' Hospital, Tampa, FL 33612, United States of America; University of South Florida, Tampa, FL 33612, United States of America. Electronic address: Kevin.White2@va.gov.""}, {'ForeName': 'Pierre K', 'Initials': 'PK', 'LastName': 'Asselin', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America; Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY 10029, United States of America. Electronic address: Pierre.Asselin@va.gov.'}, {'ForeName': 'Kel', 'Initials': 'K', 'LastName': 'Morin', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America. Electronic address: Kel.Morin@va.gov.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cirnigliaro', 'Affiliation': 'National Center for the Medical Consequences of Spinal Cord Injury, James J. Peters VA Medical Center, Bronx, NY 10468, United States of America; Kessler Institute for Rehabilitation, West Orange, NJ 07052, United States of America. Electronic address: christopher.cirnigliaro@va.gov.'}, {'ForeName': 'Grant D', 'Initials': 'GD', 'LastName': 'Huang', 'Affiliation': 'Cooperative Studies Program Central Office, VA Office of Research and Development, Washington, DC 20420, United States of America. Electronic address: grant.huang@va.gov.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106102']
2318,32800969,"Yokukansan for treatment of preoperative anxiety and prevention of postoperative delirium in cancer patients undergoing highly invasive surgery. J-SUPPORT 1605 (ProD Study): A randomized, double-blind, placebo-controlled trial.","CONTEXT


No standard preventive or therapeutic methods have been established for preoperative anxiety and postoperative delirium in cancer patients.
OBJECTIVES


To clarify the therapeutic effect of yokukansan for perioperative psychiatric symptoms in cancer patients, as well as to confirm its safety profile.
METHODS


This is a randomized, double-blind, placebo-controlled trial conducted at a single center in Tokyo, Japan. 195 cancer patients scheduled to undergo tumor resection took one packet of the study drug was administered orally. Co-primary outcomes were change in preoperative anxiety assessed with the Hospital Anxiety and Depression Scale-Anxiety (HADS-A) and incidence of postoperative delirium assessed with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Interim analysis was performed with one-third (n=74) of the target number of registered patients.
RESULTS


Because this trial was canceled based on the results of the interim analysis and the protocol treatment was discontinued in patients who were already registered, conclusions were based on the full analysis set of 160 participants. There were no significant differences between groups in the change of mean HADS-A score (intervention group [SD], 0.4 [3.0] vs. placebo group, 0.5 [3.0]; p=0.796) or the incidence of postoperative delirium (32% vs. 30%; p=0.798). There were no serious adverse events in either group.
CONCLUSION


In cancer patients undergoing highly invasive surgeries, yokukansan demonstrated no significant efficacy for the treatment of preoperative anxiety or the prevention of postoperative delirium. Yokukansan is already used in daily practice in Japan, but we should be careful with its future use.",2020,"There were no significant differences between groups in the change of mean HADS-A score (intervention group [SD], 0.4 [3.0] vs. placebo group, 0.5 [3.0]; p=0.796) or the incidence of postoperative delirium (32% vs. 30%; p=0.798).","['patients who were already registered', 'cancer patients undergoing highly invasive surgery', 'cancer patients', 'single center in Tokyo, Japan', '195 cancer patients scheduled to undergo tumor resection took one packet of the study drug was administered orally', 'cancer patients undergoing highly invasive surgeries']","['yokukansan', 'Yokukansan', 'placebo']","['change of mean HADS-A score', 'preoperative anxiety', 'incidence of postoperative delirium', 'serious adverse events', 'preoperative anxiety assessed with the Hospital Anxiety and Depression Scale-Anxiety (HADS-A) and incidence of postoperative delirium assessed with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0040371', 'cui_str': 'Tokyo'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1641805', 'cui_str': 'Packet - unit of product usage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C2001636', 'cui_str': 'Yi-Gan San'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C4721772', 'cui_str': 'Postoperative delirium'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}]",195.0,0.5259,"There were no significant differences between groups in the change of mean HADS-A score (intervention group [SD], 0.4 [3.0] vs. placebo group, 0.5 [3.0]; p=0.796) or the incidence of postoperative delirium (32% vs. 30%; p=0.798).","[{'ForeName': 'Saho', 'Initials': 'S', 'LastName': 'Wada', 'Affiliation': 'Department of Psycho-Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan; Division of Health Care Research, Behavioral Sciences and Survivorship Research Group, Center for Public Health Sciences, National Cancer Center Japan, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Ryoichi', 'Initials': 'R', 'LastName': 'Sadahiro', 'Affiliation': 'Department of Psycho-Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan; Division of Health Care Research, Behavioral Sciences and Survivorship Research Group, Center for Public Health Sciences, National Cancer Center Japan, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Yutaka J', 'Initials': 'YJ', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Psycho-Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan; Division of Health Care Research, Behavioral Sciences and Survivorship Research Group, Center for Public Health Sciences, National Cancer Center Japan, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan; Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Uchitomi', 'Affiliation': 'Department of Psycho-Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan; Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan; Behavioral Sciences and Survivorship Research Group, Center for Public Health Sciences, National Cancer Center Japan, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan.'}, {'ForeName': 'Tetsufumi', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Anesthesia and Intensive Care, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Shimada', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Seiichi', 'Initials': 'S', 'LastName': 'Yoshimoto', 'Affiliation': 'Department of Head and Neck Surgery, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Daiko', 'Affiliation': 'Department of Esophageal Surgery, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Yukihide', 'Initials': 'Y', 'LastName': 'Kanemitsu', 'Affiliation': 'Department of Colorectal Surgery, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kawai', 'Affiliation': 'Department of Musculoskeletal Oncology and Rehabilitation , National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Tomoyasu', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Gynecology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Urology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Shimizu', 'Affiliation': 'Department of Psycho-Oncology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan; Division of Health Care Research, Behavioral Sciences and Survivorship Research Group, Center for Public Health Sciences, National Cancer Center Japan, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan; Innovation Center for Supportive, Palliative and Psychosocial Care, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan. Electronic address: keshimiz@ncc.go.jp.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.07.009']
2319,32807158,Effectiveness and cerebral responses of multi-points acupuncture for primary insomnia: a preliminary randomized clinical trial and fMRI study.,"BACKGROUND


Primary insomnia (PI) is characterized by difficulties in initiating sleep or maintaining sleep, which lead to many serious diseases. Acupuncture for PI has drawn attention with its effectiveness and safety. However, the operation of choosing acupoints lacks scientific suggestion. Our trial aims to provide reference and scientific basis for the selection of acupoints and to explore its possible mechanism.
METHODS


A patient-assessor-blinded, randomized and sham controlled trial was designed to compare the efficacy of 5-weeks acupuncture at a single acupoint, the combination of multi-acupoints, and a sham point. The Pittsburgh sleep quality index and Athens Insomnia Scale questionnaire were used for the primary clinical outcomes, while polysomnography was performed for the secondary clinical outcomes. The resting state functional MRI was employed to detect the cerebral responses to acupuncture. The brain activity in resting state was measured by calculating the fractional amplitude of low-frequency fluctuations (fALFF), which reflected the idiopathic activity level of neurons in the resting state. These results were analyzed by two factorial ANOVA test and post-hoc t-tests.
RESULTS


The clinical outcomes suggest that acupuncture could improve clinical symptoms, and the combination of multi-acupoints might lead to a better clinical efficacy. The rs-fMRI results suggested that the brain activity of certain regions was related to the sleep experience, and acupuncture could regulate the activity of these regions. Furthermore, the combination of multi-acupoints could impact more regions which were influenced by the sleep experience.
CONCLUSIONS


Acupuncture has been proven to be beneficial for PI patients, and the combination of multi-acupoints might improve its efficacy.
TRIAL REGISTRATION


This trial has been registered on the U.S. National Library of Medicine (https://clinicaltrials.gov) ClinicalTrials.gov Identifier: NCT02448602 . Registered date: 14/04/2015.",2020,"The rs-fMRI results suggested that the brain activity of certain regions was related to the sleep experience, and acupuncture could regulate the activity of these regions.","['U.S. National Library of Medicine (https://clinicaltrials.gov', 'primary insomnia']","['acupuncture', 'multi-points acupuncture', 'Acupuncture']","['Pittsburgh sleep quality index and Athens Insomnia Scale questionnaire', 'clinical symptoms', 'brain activity in resting state', 'Effectiveness and cerebral responses']","[{'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0027470', 'cui_str': 'National Library of Medicine'}, {'cui': 'C0033139', 'cui_str': 'Primary insomnia'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}]","[{'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",,0.158389,"The rs-fMRI results suggested that the brain activity of certain regions was related to the sleep experience, and acupuncture could regulate the activity of these regions.","[{'ForeName': 'Yu-Kai', 'Initials': 'YK', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, China-Japan Union Hospital of Jilin University, Changchun, Jilin, 130033, P.R. China.'}, {'ForeName': 'Tie', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Department of Acupuncture and Moxibustion, Changchun University of Chinese Medicine, Changchun, Jilin, 130117, P.R. China.'}, {'ForeName': 'Li-Juan', 'Initials': 'LJ', 'LastName': 'Ha', 'Affiliation': 'Department of Acupuncture and Moxibustion, Changchun University of Chinese Medicine, Changchun, Jilin, 130117, P.R. China.'}, {'ForeName': 'Zhong-Wen', 'Initials': 'ZW', 'LastName': 'Lv', 'Affiliation': 'Department of Radiology, China-Japan Union Hospital of Jilin University, Changchun, Jilin, 130033, P.R. China.'}, {'ForeName': 'Fu-Chun', 'Initials': 'FC', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Changchun University of Chinese Medicine, Changchun, Jilin, 130117, P.R. China.'}, {'ForeName': 'Zhi-Hong', 'Initials': 'ZH', 'LastName': 'Wang', 'Affiliation': 'Department of Acupuncture and Moxibustion, Changchun University of Chinese Medicine, Changchun, Jilin, 130117, P.R. China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Mang', 'Affiliation': 'Department of Neurology, China-Japan Union Hospital of Jilin University, Changchun, Jilin, 130033, P.R. China.'}, {'ForeName': 'Zhong-Xin', 'Initials': 'ZX', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, China-Japan Union Hospital of Jilin University, Changchun, Jilin, 130033, P.R. China. xuzhongxin9999@sina.com.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-02969-6']
2320,32807162,Cinnamaldehyde is a biologically active compound for the disinfection of removable denture: blinded randomized crossover clinical study.,"BACKGROUND


Fungal infections associated with the use of dentures, like denture stomatitis, are difficult to prevent and treat. This in situ study aimed to investigate the efficacy of cinnamaldehyde for the disinfection of complete removable dentures, and the effect on the physical and mechanical properties (Vickers microhardness, color, and surface roughness) of the acrylic resin.
METHODS


Acrylic resin disks were inserted into the dentures of a probabilistic sample of 33 complete denture users, that used cinnamaldehyde (27 μg/mL) and 0.5% sodium hypochlorite solutions in a 20 min/7-days protocol of dentures immersion in each solution, with a wash-out period of 7 days, to constitute a crossover-study. The disks were analyzed before and after the immersion, for the presence of microorganisms (CFU/mL) and by scanning electron microscope (SEM). Also, the surface roughness (Ra) and Vickers microhardness were measured, and color parameters were analyzed using the National Bureau of Standards (NBS) method. Data was analyzed by Wilcoxon and Friedman (microbiological evaluation), paired t-test (color and roughness) and independent t-test (Vickers hardness) (α = 0.05).
RESULTS


A significant reduction (P < 0.05) in the number of microorganisms was observed for each species (total microorganisms, Streptococcus mutans, and Candida spp.), with no significant differences (P > 0.05) between hypochlorite and cinnamaldehyde. There was an increase in the roughness and a decrease in the hardness of the test specimens, with no difference between the two disinfectant substances (P > 0.05). Both hypochlorite and cinnamaldehyde also caused changes in color, considered as ""perceptible"" by the NBS classification, but with no significant difference between disinfectant substances (P < 0.05), and under the clinically acceptable limit (ΔE ≤ 3.7).
CONCLUSION


The 27 μg/mL cinnamaldehyde solution was effective against all evaluated microorganisms and caused minor alterations in hardness, surface roughness, and color parameters, with no clinical relevance.",2020,"A significant reduction (P < 0.05) in the number of microorganisms was observed for each species (total microorganisms, Streptococcus mutans, and Candida spp.), with no significant differences (P > 0.05) between hypochlorite and cinnamaldehyde.","['Acrylic resin disks were inserted into the dentures of a probabilistic sample of 33 complete denture users, that used cinnamaldehyde (27\u2009μg/mL) and 0.5']",['sodium hypochlorite solutions'],"['Wilcoxon and Friedman (microbiological evaluation), paired t-test (color and roughness', 'surface roughness (Ra) and Vickers microhardness', 'hardness, surface roughness, and color parameters', 'number of microorganisms']","[{'cui': 'C0001222', 'cui_str': 'Acrylic Resins'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0011394', 'cui_str': 'Denture'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0011455', 'cui_str': 'Complete denture'}, {'cui': 'C0055754', 'cui_str': 'cinnamic aldehyde'}, {'cui': 'C0444500', 'cui_str': '0.5'}]","[{'cui': 'C0037518', 'cui_str': 'sodium hypochlorite'}]","[{'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.0518367,"A significant reduction (P < 0.05) in the number of microorganisms was observed for each species (total microorganisms, Streptococcus mutans, and Candida spp.), with no significant differences (P > 0.05) between hypochlorite and cinnamaldehyde.","[{'ForeName': 'Marco Antônio Lavorato', 'Initials': 'MAL', 'LastName': 'de Almeida', 'Affiliation': 'Faculty of Dentistry, Department of Clinical and Social Dentistry, Federal University of Paraíba, Campus I, João Pessoa, PB, 58051-970, Brazil.'}, {'ForeName': 'André Ulisses Dantas', 'Initials': 'AUD', 'LastName': 'Batista', 'Affiliation': 'Faculty of Dentistry, Department of Clinical and Social Dentistry, Federal University of Paraíba, Campus I, João Pessoa, PB, 58051-970, Brazil.'}, {'ForeName': 'Maria Rejane Cruz', 'Initials': 'MRC', 'LastName': 'de Araújo', 'Affiliation': 'Faculty of Dentistry, Department of Clinical and Social Dentistry, Federal University of Paraíba, Campus I, João Pessoa, PB, 58051-970, Brazil.'}, {'ForeName': 'Vanessa Fabiana Dei Santi', 'Initials': 'VFDS', 'LastName': 'de Almeida', 'Affiliation': 'Faculty of Dentistry, Department of Clinical and Social Dentistry, Federal University of Paraíba, Campus I, João Pessoa, PB, 58051-970, Brazil.'}, {'ForeName': 'Paulo Rogério Ferreti', 'Initials': 'PRF', 'LastName': 'Bonan', 'Affiliation': 'Faculty of Dentistry, Department of Clinical and Social Dentistry, Federal University of Paraíba, Campus I, João Pessoa, PB, 58051-970, Brazil.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Nóbrega Alves', 'Affiliation': 'Faculty of Dentistry, Department of Clinical and Social Dentistry, Federal University of Paraíba, Campus I, João Pessoa, PB, 58051-970, Brazil.'}, {'ForeName': 'Tereza Karla Vieira Lopes', 'Initials': 'TKVL', 'LastName': 'da Costa', 'Affiliation': 'Faculty of Dentistry, Department of Clinical and Social Dentistry, Federal University of Paraíba, Campus I, João Pessoa, PB, 58051-970, Brazil.'}, {'ForeName': 'Diego Figueiredo', 'Initials': 'DF', 'LastName': 'Nóbrega', 'Affiliation': 'Faculty of Dentistry, Department of Clinical and Social Dentistry, Federal University of Paraíba, Campus I, João Pessoa, PB, 58051-970, Brazil.'}, {'ForeName': 'Ricardo Dias', 'Initials': 'RD', 'LastName': 'de Castro', 'Affiliation': 'Faculty of Dentistry, Department of Clinical and Social Dentistry, Federal University of Paraíba, Campus I, João Pessoa, PB, 58051-970, Brazil. rcastro@ccs.ufpb.br.'}]",BMC oral health,['10.1186/s12903-020-01212-5']
2321,32807165,"Fortified whey beverage for improving muscle mass in chronic obstructive pulmonary disease: a single-blind, randomized clinical trial.","BACKGROUND


The development of effective nutritional supports for patients with chronic obstructive pulmonary diseases (COPD) is still challenging. This study was conducted to investigate the efficacy of daily consumption of fortified whey on inflammation, muscle mass, functionality, and quality of life in patients with moderate-to-severe COPD.
METHODS


A single-blind, randomized trial study was performed on patients with COPD (n = 46). Participants in the intervention group (n = 23) daily received 250 ml of whey beverage fortified with magnesium and vitamin C for 8 weeks. Any changes in inflammatory cytokines (including interleukin- 6 (IL-6) and tumor necrosis factor (TNFα)) were the primary outcomes and the secondary outcomes were fat-free mass, handgrip strength, malnutrition, glutathione and malondialdehyde serum concentrations, and health-related quality of life (HRQoL). Body composition and muscle strength were measured by Bioelectrical Impedance Analysis (BIA) and hydraulic hand dynamometer, respectively. Fat-free mass index (FFMI) was also calculated.
RESULTS


At the end of the study, 44 patients were analyzed. There were significant decreases in IL-6 concentrations in the intervention group compared to the control group. Also, FFMI, body protein, and handgrip strength increased significantly in the intervention group with significant changes between two groups. Moreover, improvement in health-related quality of life was observed in the intervention group compared to the control group. There were no significant changes in other study variables.
CONCLUSIONS


This novel nutritional intervention decreased inflammatory cytokines levels, improved indices of skeletal muscle mass and muscle strength, and ultimately, increased HRQoL in patients with moderate-to-severe COPD. Thus, it is suggested to do further studies to assess the effects of nutrition intervention on COPD progression.
TRIAL REGISTRATION


IR.SUMS.REC.1396.85 ( https://www.irct.ir/ ).",2020,"Any changes in inflammatory cytokines (including interleukin- 6 (IL-6) and tumor necrosis factor (TNFα)) were the primary outcomes and the secondary outcomes were fat-free mass, handgrip strength, malnutrition, glutathione and malondialdehyde serum concentrations, and health-related quality of life (HRQoL).","['chronic obstructive pulmonary disease', 'patients with moderate-to-severe COPD', 'patients with COPD (n\u2009=\u200946', 'patients with chronic obstructive pulmonary diseases (COPD', '44 patients were analyzed']","['Fortified whey beverage', 'nutrition intervention', '250\u2009ml of whey beverage fortified with magnesium and vitamin C']","['fat-free mass, handgrip strength, malnutrition, glutathione and malondialdehyde serum concentrations, and health-related quality of life (HRQoL', 'inflammatory cytokines levels', 'inflammatory cytokines (including interleukin- 6 (IL-6) and tumor necrosis factor (TNFα', 'IL-6 concentrations', 'skeletal muscle mass and muscle strength, and ultimately, increased HRQoL', 'health-related quality of life', 'FFMI, body protein, and handgrip strength', 'inflammation, muscle mass, functionality, and quality of life', 'Body composition and muscle strength', 'Fat-free mass index (FFMI']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",44.0,0.0699522,"Any changes in inflammatory cytokines (including interleukin- 6 (IL-6) and tumor necrosis factor (TNFα)) were the primary outcomes and the secondary outcomes were fat-free mass, handgrip strength, malnutrition, glutathione and malondialdehyde serum concentrations, and health-related quality of life (HRQoL).","[{'ForeName': 'Afsane', 'Initials': 'A', 'LastName': 'Ahmadi', 'Affiliation': 'Research Center for Health Sciences, Institute of Health, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Hassan', 'Initials': 'MH', 'LastName': 'Eftekhari', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran. h_eftekhari@yahoo.com.'}, {'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Mazloom', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Masoom', 'Initials': 'M', 'LastName': 'Masoompour', 'Affiliation': 'Non-communicable Disease Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Fararooei', 'Affiliation': 'Department of Epidemiology, School of Health, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Hadi', 'Initials': 'MH', 'LastName': 'Eskandari', 'Affiliation': 'Department of Food Sciences and Technology, School of Agriculture, Shiraz University, Shiraz, Iran.'}, {'ForeName': 'Samrad', 'Initials': 'S', 'LastName': 'Mehrabi', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Bedeltavana', 'Affiliation': 'Dairy Expert at Research and Development of Zarrin Ghazal Company (DAITY), Shiraz, Iran.'}, {'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Famouri', 'Affiliation': 'Dairy Expert at Research and Development of Zarrin Ghazal Company (DAITY), Shiraz, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Zare', 'Affiliation': 'Nutrition Reasearch Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Nasimi', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Sohrabi', 'Affiliation': 'Department of Community Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Respiratory research,['10.1186/s12931-020-01466-1']
2322,32807173,Effect of concentrated growth factors on frequency of alveolar Osteitis following partially-erupted mandibular third molar surgery: a randomized controlled clinical study.,"BACKGROUND


The aim of this prospective study was to assess the effectiveness of concentrated growth factors (CGF) in preventing the development of alveolar osteitis (AO) after the extraction of partially-erupted mandibular third molars.
METHODS


Seventy patients (26 men and 44 women) 18 years or older (mean age 25.86; range 18-35) underwent 140 third molar extractions. All the patients presented with bilateral, partially-erupted mandibular third molars and underwent surgical extractions. In each case, one socket received CGF and the other served as a control. The predictor variable was the CGF application and the sides were categorized as 'CGF' and 'non-CGF'. The outcome variable was the development of AO during the first postoperative week. Other study variables included age and gender. Data were analyzed using Cochran's Q test with the significance level set at a P value less than 0.05.
RESULTS


The overall frequency of AO was 11.4% for the control group. The frequency of AO in the CGF group was significantly lower than in the non-CGF group (p < 0.001).
CONCLUSIONS


Based on the results of this study, application of CGF fibrin gel may decrease the risk of AO development after mandibular third molar surgery.
TRIAL REGISTRATION


This study was registered in ClinicalTrials.gov database on November 1, 2019 (ID: NCT04151147 , retrospectively registered).",2020,"The frequency of AO in the CGF group was significantly lower than in the non-CGF group (p < 0.001).
","['partially-erupted mandibular third molars', 'patients presented with bilateral, partially-erupted mandibular third molars and underwent surgical extractions', 'Seventy patients (26 men and 44 women) 18\u2009years or older (mean age 25.86; range 18-35) underwent 140 third molar extractions', 'partially-erupted mandibular third molar surgery']","['concentrated growth factors', 'concentrated growth factors (CGF', 'CGF fibrin gel', 'CGF']","['frequency of alveolar Osteitis', 'frequency of AO', 'development of AO', 'risk of AO development', 'overall frequency of AO', 'alveolar osteitis (AO']","[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1293139', 'cui_str': 'Surgical extraction'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0013240', 'cui_str': 'Alveolar periostitis'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0915852,"The frequency of AO in the CGF group was significantly lower than in the non-CGF group (p < 0.001).
","[{'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Özveri Koyuncu', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, Ege Univeristy, Bornova, İzmir, Turkey. banuozverikoyuncu@yahoo.com.'}, {'ForeName': 'Gözde', 'Initials': 'G', 'LastName': 'Işık', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, Ege Univeristy, Bornova, İzmir, Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Özden Yüce', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, Ege Univeristy, Bornova, İzmir, Turkey.'}, {'ForeName': 'Sevtap', 'Initials': 'S', 'LastName': 'Günbay', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, Ege Univeristy, Bornova, İzmir, Turkey.'}, {'ForeName': 'Tayfun', 'Initials': 'T', 'LastName': 'Günbay', 'Affiliation': 'Department of Oral Surgery, Faculty of Dentistry, Ege Univeristy, Bornova, İzmir, Turkey.'}]",BMC oral health,['10.1186/s12903-020-01210-7']
2323,32801531,The Comparison of Utilizing Piezotome and Surgical Disc in Ridge Splitting of Atrophic Edentulous Maxillary Ridge.,"Objective


Narrow dentoalveolar ridges remain a serious challenge for the successful placement of dental implants. The aim of this study was to compare the clinical outcomes of piezosurgery versus surgical disc on ridge splitting in the atrophic edentulous maxilla.
Materials and Methods


This was a double-blinded randomized clinical trial. The healthy subjects who were candidates for maxillary ridge expansion were included in this experiment. Patients were randomly divided into two groups: piezosurgery group and surgical disc group. The width of the bone in the surgical site was measured by surgical calliper before the osteotomy. The bone width was remeasured after ridge-split completion (before suturing) and during the implant placement (4 months later). Then data were analysed by SPSS software, and the  P  value was set at 0.05.
Results


The study sample size included 20 cases. Our outcomes showed that both techniques (surgical disc and piezotome) were effective in ridge splitting ( P  < 0.001). However, the average bone width which was obtained after ridge splitting was significantly higher in the piezosurgery group ( P  < 0.05).
Conclusion


It can be concluded that both methods of piezosurgery and surgical disc can significantly lead to increase in the ridge width. However, the piezosurgery technique was more effective in ridge splitting.",2020,Our outcomes showed that both techniques (surgical disc and piezotome) were effective in ridge splitting ( P  < 0.001).,['healthy subjects who were candidates for maxillary ridge expansion'],"['piezosurgery group and surgical disc group', 'Piezotome and Surgical Disc', 'piezosurgery versus surgical disc']","['average bone width', 'effective in ridge splitting', 'bone width']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}]","[{'cui': 'C3178856', 'cui_str': 'Piezo-Electric Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C1444777', 'cui_str': 'Splitting sensation quality'}]",20.0,0.0352655,Our outcomes showed that both techniques (surgical disc and piezotome) were effective in ridge splitting ( P  < 0.001).,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Shahakbari', 'Affiliation': 'Oral and Maxillofacial Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Eshghpour', 'Affiliation': 'Oral and Maxillofacial Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Vajiheh', 'Initials': 'V', 'LastName': 'Mianbandi', 'Affiliation': 'Mashhad Dental School, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Solmaz', 'Initials': 'S', 'LastName': 'Pourgonabadi', 'Affiliation': 'Oral and Maxillofacial Surgery Department, Mashhad Dental School, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Tohidi', 'Affiliation': 'Oral and Maxillofacial Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Seyed Jalal', 'Initials': 'SJ', 'LastName': 'Seyedi', 'Affiliation': 'Mashhad Dental School, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Sahand', 'Initials': 'S', 'LastName': 'Samieirad', 'Affiliation': 'Oral and Maxillofacial Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-019-01253-6']
2324,32801534,Comparative Evaluation of IV Paracetamol Versus IV Dexmedetomidine in Inpatient Oral and Maxillofacial Surgery: A Double-Blinded Randomized Controlled Study.,"Purpose


Reconstructive surgeries following fractures in the maxillofacial region often involve considerable bone manipulation, and paracetamol is a commonly used analgesic medication in both intraoperative and postoperative periods. Dexmedetomidine, an alpha-2 adrenoceptor agonist, has both sedative and analgesic properties with minimal cardiorespiratory effects and has been used primarily for its sedative properties in oral and maxillofacial surgery.
Aims and Objectives


To compare the intraoperative analgesic requirements among patients undergoing oral and maxillofacial surgery who receive IV paracetamol versus IV dexmedetomidine. The time to requirement for the first postoperative analgesic dose and safety and adverse events of both medications were also assessed.
Patients and Methods


In total, 64 patients needing primary reconstructive surgery for facial fractures were recruited and divided into two groups for this double-blinded study. Patients were randomized to receive a preinduction dose of either IV paracetamol 1 g (Group P) or IV dexmedetomidine 1 µg/kg (Group D). Sedation scores (Ramsay sedation scale), maximal interincisal distance and pain scores at maximal mouth opening (visual analogue scale) were assessed in both groups just prior to and after the administration of the study drugs. After induction, Group P and Group D received a maintenance dose of normal saline and dexmedetomidine (0.5 µg/kg/h) during the intraoperative period, respectively. Standard noninvasive cardiorespiratory monitoring was done for the entire duration of surgery. Following extubation, postoperative pain scores and the time to request for first analgesic dose in either group were recorded.
Results


The time taken to perform the surgery was comparable in both groups. There was a significant difference between the groups in visual analogue scores and interincisal distance after the bolus dose ( p  < 0.05). Systolic and diastolic blood pressure was significantly lower in Group D at around 150 and 175 min of surgery. While the intraoperative fentanyl consumption was comparable in both groups, the time to request for the first analgesic dose in the postoperative period was significantly delayed in Group P ( p  < 0.05). No adverse cardiopulmonary events were observed in either group.
Conclusion


The intraoperative anesthetic and analgesic requirements and hemodynamic stability were comparable in IV paracetamol and dexmedetomidine groups. Dexmedetomidine did not confer any enhanced analgesia effect in the postoperative period. More research examining the role of dexmedetomidine for longer duration inpatient oral and maxillofacial surgery is needed.
Clinical Trial Number


http://ClinicalTrials.gov (No. CTRI/2017/08/009468).",2020,The intraoperative anesthetic and analgesic requirements and hemodynamic stability were comparable in IV paracetamol and dexmedetomidine groups.,"['patients undergoing oral and maxillofacial surgery who receive', '64 patients needing primary reconstructive surgery for facial fractures']","['Maxillofacial Surgery', 'Dexmedetomidine', 'IV paracetamol 1\xa0g (Group P) or IV dexmedetomidine', 'IV Paracetamol', 'IV paracetamol versus IV dexmedetomidine', 'normal saline and dexmedetomidine', 'dexmedetomidine']","['intraoperative anesthetic and analgesic requirements and hemodynamic stability', 'Sedation scores (Ramsay sedation scale), maximal interincisal distance and pain scores at maximal mouth opening (visual analogue scale', 'adverse cardiopulmonary events', 'Systolic and diastolic blood pressure', 'visual analogue scores and interincisal distance', 'intraoperative analgesic requirements', 'intraoperative fentanyl consumption', 'analgesia effect', 'postoperative pain scores and the time to request for first analgesic dose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0038908', 'cui_str': 'Oral surgery'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0441849', 'cui_str': 'Group P'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0559295', 'cui_str': 'Ramsay sedation scale'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",64.0,0.16956,The intraoperative anesthetic and analgesic requirements and hemodynamic stability were comparable in IV paracetamol and dexmedetomidine groups.,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Guru', 'Affiliation': 'Department of Anesthesiology and Critical Care, Jawaharalal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605005 India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Adinarayanan', 'Affiliation': 'Department of Anesthesiology and Critical Care, Jawaharalal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605005 India.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Krishnan', 'Affiliation': 'Department of Dentistry, Jawaharalal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605005 India.'}, {'ForeName': 'Satyen', 'Initials': 'S', 'LastName': 'Parida', 'Affiliation': 'Department of Anesthesiology and Critical Care, Jawaharalal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605005 India.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hemavathi', 'Affiliation': 'Department of Anesthesiology and Critical Care, Jawaharalal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605005 India.'}, {'ForeName': 'Prasanna Udupi', 'Initials': 'PU', 'LastName': 'Bidkar', 'Affiliation': 'Department of Anesthesiology and Critical Care, Jawaharalal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605005 India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Narmadhalakshmi', 'Affiliation': 'Department of Anesthesiology and Critical Care, Jawaharalal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry, 605005 India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-019-01264-3']
2325,32801540,"Efficacy of Infiltration Anaesthesia of 4% Articaine HCl (buccal) Versus 2% Lignocaine HCl (buccolingual) in Extraction of Mandibular Premolars: A Single Centred, Randomised, Crossover Group Study.","Purpose


The purpose of the study was to evaluate and compare the efficacy of buccal and lingual infiltration (B/L I) of 2% lignocaine HCl and buccal infiltration (BI) of 4% articaine for orthodontic extraction of mandibular premolars.
Materials and Method


One hundred and four patients (age group 14-26 years) were selected with the indication of bilateral mandibular first or second premolar extraction for orthodontic treatment. Patients were randomly distributed in 2 groups. Group A received B/L I with lignocaine and Group B for BI with articaine in two different appointments in 2-week interval. The pain scores for each patient were evaluated during extraction using the visual analogue scale (VAS) and verbal pain scale (VPS). Statistical analysis was performed by descriptive and inferential statistics using Chi-square test. The agreement between VAS and VPS was obtained by applying intra-class correlation coefficient.
Results


No pain was experienced during extraction in 77% (VAS) and 79% (VPS) patients infiltrated in group A and 84% (VAS) and 90% (VPS) patients of group B with articaine. The difference between the groups was statistically significant. A strong positive correlation was found between VAS and VPS scores in the both groups.
Conclusion


Buccal infiltration with articaine proved to be an effective alternative to buccal and lingual infiltration with lignocaine in the extraction of mandibular premolars.",2020,"Conclusion


Buccal infiltration with articaine proved to be an effective alternative to buccal and lingual infiltration with lignocaine in the extraction of mandibular premolars.","['One hundred and four patients (age group 14-26\xa0years) were selected with the indication of bilateral mandibular first or second premolar extraction for orthodontic treatment', 'orthodontic extraction of mandibular premolars', 'Mandibular Premolars']","['Infiltration Anaesthesia of 4% Articaine HCl (buccal', 'Lignocaine HCl (buccolingual', 'lignocaine HCl and buccal infiltration (BI) of 4% articaine', 'articaine', 'lignocaine']","['visual analogue scale (VAS) and verbal pain scale (VPS', 'pain scores', 'VAS and VPS scores', 'effective alternative to buccal and lingual infiltration', 'pain', 'VAS and VPS']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}]","[{'cui': 'C0234945', 'cui_str': 'Infiltration anaesthesia'}, {'cui': 'C0007300', 'cui_str': 'Articaine hydrochloride'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0023443', 'cui_str': 'Hairy cell leukemia'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C1608295', 'cui_str': 'Articaine'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",104.0,0.016704,"Conclusion


Buccal infiltration with articaine proved to be an effective alternative to buccal and lingual infiltration with lignocaine in the extraction of mandibular premolars.","[{'ForeName': 'Ajit', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Department of Dentistry, Government Medical College, Ram Nagar, Chandrapur, Maharashtra 442402 India.'}, {'ForeName': 'Harleen Kaur', 'Initials': 'HK', 'LastName': 'Soni', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Manubhai Patel Dental College, Near Vishwajoti Ashram, Munjmahuda, Vadodara, Gujarat 390011 India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-019-01297-8']
2326,32801545,Effect of Diagnosis by Two-Dimensional Radiography Versus CBCT on Surgical Aspects of Transmigrated Impacted Mandibular Canines.,"Purpose


The transmigration of mandibular canines is a rare clinical finding. The present study aimed to compare the effect of diagnosis by two-dimensional radiography and cone beam computed tomography on surgical aspects of transmigrated impacted mandibular canines.
Patients and Methods


A total of 20 patients (mean age 20.18 ± 3.36 years; male/female = 1.5:1), reporting to the Department of Oral and Maxillofacial Surgery with transmigrated impacted mandibular canines and planned for surgical removal, were randomly divided into two groups of ten patients each. Group A patients were diagnosed using 2D radiographs (orthopantomograms and occlusal view radiographs), and Group B patients were diagnosed using CBCT scans. The effects of the diagnosis on surgical aspects were compared in both the groups using various intraoperative and post-operative parameters.
Results


The operating surgeons experienced lesser operating time and more accuracy in terms of prediction of surgical approach in Group B patients than in Group A. Post-operative complications, including post-operative vitality of the adjacent tooth and lower lip paraesthesia, were seen to be more in Group A patients than in Group B.
Conclusion


Increased precision in localization of transmigrated impacted mandibular canines was seen by using CBCT, leading to better surgical experience and lesser post-operative complications.",2020,"The operating surgeons experienced lesser operating time and more accuracy in terms of prediction of surgical approach in Group B patients than in Group A. Post-operative complications, including post-operative vitality of the adjacent tooth and lower lip paraesthesia, were seen to be more in Group A patients than in Group B.
Conclusion


Increased precision in localization of transmigrated impacted mandibular canines was seen by using CBCT, leading to better surgical experience and lesser post-operative complications.","['Transmigrated Impacted Mandibular Canines', 'Patients and Methods\n\n\nA total of 20 patients (mean age 20.18\u2009±\u20093.36\xa0years; male/female\u2009=\u20091.5:1), reporting to the Department of Oral and Maxillofacial Surgery with transmigrated impacted mandibular canines and planned for surgical removal']","['dimensional radiography and cone beam computed tomography', 'Diagnosis by Two-Dimensional Radiography Versus CBCT']",['post-operative vitality of the adjacent tooth and lower lip paraesthesia'],"[{'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0226942', 'cui_str': 'External lower lip'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}]",20.0,0.0220679,"The operating surgeons experienced lesser operating time and more accuracy in terms of prediction of surgical approach in Group B patients than in Group A. Post-operative complications, including post-operative vitality of the adjacent tooth and lower lip paraesthesia, were seen to be more in Group A patients than in Group B.
Conclusion


Increased precision in localization of transmigrated impacted mandibular canines was seen by using CBCT, leading to better surgical experience and lesser post-operative complications.","[{'ForeName': 'Swapan Kumar', 'Initials': 'SK', 'LastName': 'Majumdar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dr. R. Ahmed Dental College and Hospital, Kolkata, India.'}, {'ForeName': 'Md Arif', 'Initials': 'MA', 'LastName': 'Hossain', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dr. R. Ahmed Dental College and Hospital, Kolkata, India.'}, {'ForeName': 'Nayana', 'Initials': 'N', 'LastName': 'De', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dr. R. Ahmed Dental College and Hospital, Kolkata, India.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Chadda', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dr. R. Ahmed Dental College and Hospital, Kolkata, India.'}, {'ForeName': 'Malay Kanti', 'Initials': 'MK', 'LastName': 'Bachhar', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dr. R. Ahmed Dental College and Hospital, Kolkata, India.'}, {'ForeName': 'Siddhartha', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dr. R. Ahmed Dental College and Hospital, Kolkata, India.'}]",Journal of maxillofacial and oral surgery,['10.1007/s12663-020-01331-0']
2327,32801612,Anterior Lamellar Recession versus Posterior Lamellar Tarsal Rotation for Lower Lid Trachomatous Trichiasis: A Randomized Controlled Trial.,"Purpose


To compare the outcomes of anterior lamellar recession (ALR) versus posterior lamellar tarsal rotation (PLTR) procedure for the repair of lower eyelid trachomatous trichiasis (TT).
Design


Prospective randomized comparative trial.
Methods


Study Population and Interventions: Patients with lower eyelid TT were enrolled. Patients with a history of lower lid surgery, marked horizontal lid laxity, another evident cause for the trichiasis, and those under 18 years were excluded. Participants were randomized to either PLTR or ALR. The sequence was computer-generated by an independent statistician, and the allocation sequence was concealed in sealed opaque envelops. Patients were evaluated at 1 week and 1, 3, 6, and 12 months. Main Outcome Measures: postoperative trachomatous trichiasis (PTT) and cosmetic satisfaction.
Results


A total of 60 patients were randomly assigned with 30 patients in each group. Two (3.3%) participants in PLTR group did not follow up and were excluded from the analysis. At 1, 3, and 6 months, PTT was significantly more frequent in the PLTR group than the ALR group (14.3% vs 0%; p= 0.048, 25% vs 0%; p= 0.004, 35.7% vs 10%; p= 0.019, respectively). In the ALR group, 6 patients (20%) had PTT at their 12-month follow-up visit compared with 15 patients (53.6%) in the PLTR group (P = 0.008) with absolute risk reduction of 33.6% (95% (CI= 9% -58%)). Cosmetic dissatisfaction was significantly more frequent in the ALR group at the initial follow-up visits compared to the PLTR group. However, this difference was no longer significant at 6 and 12 months follow-up.
Conclusion


These data provide strong evidence that ALR is more effective in correction of lower eyelid trachomatous trichiasis with acceptable cosmesis compared with PLTR.",2020,Cosmetic dissatisfaction was significantly more frequent in the ALR group at the initial follow-up visits compared to the PLTR group.,"['60 patients were randomly assigned with 30 patients in each group', 'Patients with a history of lower lid surgery, marked horizontal lid laxity, another evident cause for the trichiasis, and those under 18 years were excluded', 'Methods\n\n\nStudy Population and Interventions: Patients with lower eyelid TT were enrolled']","['Anterior Lamellar Recession versus Posterior Lamellar Tarsal Rotation', 'PLTR or ALR', 'anterior lamellar recession (ALR) versus posterior lamellar tarsal rotation (PLTR) procedure']","['Cosmetic dissatisfaction', 'postoperative trachomatous trichiasis (PTT) and cosmetic satisfaction', 'absolute risk reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0221259', 'cui_str': 'Malposition of eyelashes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0229258', 'cui_str': 'Lower eyelid structure'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0221259', 'cui_str': 'Malposition of eyelashes'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",60.0,0.0943837,Cosmetic dissatisfaction was significantly more frequent in the ALR group at the initial follow-up visits compared to the PLTR group.,"[{'ForeName': 'Fatma M', 'Initials': 'FM', 'LastName': 'Abdelaziz', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Fayoum University, Al Fayoum, Egypt.'}, {'ForeName': 'Mahmoud Ahmed', 'Initials': 'MA', 'LastName': 'Kamal', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Fayoum University, Al Fayoum, Egypt.'}, {'ForeName': 'Mohamed M', 'Initials': 'MM', 'LastName': 'Said', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Fayoum University, Al Fayoum, Egypt.'}, {'ForeName': 'Mostafa M', 'Initials': 'MM', 'LastName': 'Diab', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Fayoum University, Al Fayoum, Egypt.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S261783']
2328,32801613,Initial Treatment Response in Ocular Myasthenia Gravis: A Comparison Between Low and Moderate Doses of Prednisolone.,"Purpose


To evaluate the initial treatment response to low doses of prednisolone, compared with moderate doses, in ocular myasthenia gravis (OMG).
Patients and Methods


A retrospective chart review of patients with adult-onset (age ≥15 years old) OMG, who were treated with prednisolone, was conducted. Subjects were divided into two groups according to their prednisolone dosing regimen. The low-dose group was defined as those with an average 12-week cumulative dose of prednisolone <0.435 mg/kg/day and the moderate-dose group averaged 0.435-1.000 mg/kg/day. The primary outcome of interest was the comparison of clinical response to prednisolone at 12 weeks between the low-dose and moderate-dose groups. The secondary outcome was the difference in adverse events between treatment groups.
Results


Of 34 subjects, 16 subjects (47.1%) were male. The mean age at onset was 44.0±18.1 years. The most common presenting ocular feature was ptosis with ophthalmoplegia (22 subjects, 64.7%), followed by isolated ptosis (nine subjects, 26.5%) and isolated ophthalmoplegia (three subjects, 8.8%). Half of the subjects were treated with low-dose prednisolone and the other half were treated with moderate-dose prednisolone. There were no substantial differences in baseline characteristics between treatment groups. After 12 weeks of treatment, nine of 17 subjects (52.9%) and 13 of 17 subjects (76.5%) in the low- and moderate-dose groups, respectively, were regarded as responsive to the prednisolone treatment ( P =0.28). Adverse events were exclusively observed in the moderate-dose group.
Conclusion


Treatment of OMG with an average 12-week cumulative dose of prednisolone <0.435 mg/kg/day (low dose) shows a comparable responsive outcome to 0.435-1.000 mg/kg/day of prednisolone (moderate dose). Treating OMG with low-dose prednisolone can minimize prednisolone-related adverse events. However, a prospective randomized controlled trial with a larger study population is warranted in order to gain more insight into the proper dosage of prednisolone for OMG.",2020,"After 12 weeks of treatment, nine of 17 subjects (52.9%) and 13 of 17 subjects (76.5%) in the low- and moderate-dose groups, respectively, were regarded as responsive to the prednisolone treatment ( P =0.28).","['Ocular Myasthenia Gravis', 'ocular myasthenia gravis (OMG', 'patients with adult-onset (age ≥15 years old) OMG, who were treated with', '34 subjects, 16 subjects (47.1%) were male']","['Prednisolone', 'prednisolone']","['Adverse events', 'adverse events', 'isolated ophthalmoplegia']","[{'cui': 'C0751340', 'cui_str': 'Ocular myasthenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0029089', 'cui_str': 'Ophthalmoplegia'}]",34.0,0.0377447,"After 12 weeks of treatment, nine of 17 subjects (52.9%) and 13 of 17 subjects (76.5%) in the low- and moderate-dose groups, respectively, were regarded as responsive to the prednisolone treatment ( P =0.28).","[{'ForeName': 'Thanatporn', 'Initials': 'T', 'LastName': 'Threetong', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Anuchit', 'Initials': 'A', 'LastName': 'Poonyathalang', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Pisit', 'Initials': 'P', 'LastName': 'Preechawat', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Panitha', 'Initials': 'P', 'LastName': 'Jindahra', 'Affiliation': 'Department of Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Tanyatuth', 'Initials': 'T', 'LastName': 'Padungkiatsagul', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kavin', 'Initials': 'K', 'LastName': 'Vanikieti', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S261259']
2329,32801649,Bioequivalence Study of Amitriptyline Hydrochloride Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions.,"Purpose


This study compares the pharmacokinetic and safety profiles between a new generic and a branded reference formulation of amitriptyline hydrochloride tablets, and assesses the bioequivalence of the two products in healthy Chinese volunteers to obtain sufficient evidence for the marketing approval of the generic drug.
Materials and Methods


A randomized, open-label, two-period crossover study (clinicaltrials.gov, NCT03646526) was conducted under both fasting and fed conditions in healthy Chinese volunteers (24 subjects/condition). Eligible subjects randomly received a single 25 mg dose of either the test or the reference formulation, followed by a 3-week washout period. Blood samples were collected until 144 h following administration. The pharmacokinetic parameters were acquired based on the concentration-time profiles, including the areas under the plasma concentration-time curve (AUC 0-t , AUC 0-∞ ), the peak plasma concentration (C max ), the time to achieve C max  (T max ), and the elimination half-life (t 1/2 ). The geometric mean ratios (GMRs) and the corresponding 90% confidence intervals (CIs) of amitriptyline were acquired for bioequivalence analysis, and values of these parameters for nortriptyline were used for comparison of therapeutic outcomes. Safety assessments included laboratory tests, physical examination, vital signs, and incidence of adverse events (AEs).
Results


The values of t 1/2  and T max  for amitriptyline were not significantly different between the test and reference products under both fasting and fed conditions (P > 0.05). The GMRs of C max , AUC 0-t , and AUC 0-∞  between the two products, and corresponding 90% CIs, were all within the range of 80% to 125% under both fasting and fed conditions. The test and reference products were well tolerated and did not elicit serious adverse events.
Conclusion


This study demonstrated that the generic and reference products were well tolerated by the subjects and bioequivalent, according to the rate and extent of the drug absorption.",2020,The values of t 1/2  and T max  for amitriptyline were not significantly different between the test and reference products under both fasting and fed conditions (P > 0.05).,"['healthy Chinese volunteers', 'Healthy Chinese Volunteers', 'healthy Chinese volunteers (24 subjects/condition']","['Amitriptyline Hydrochloride Tablets', 'amitriptyline', 'amitriptyline hydrochloride tablets']","['Blood samples', 'plasma concentration-time curve (AUC 0-t , AUC 0-∞ ), the peak plasma concentration (C max ), the time to achieve C max  (T max ), and the elimination half-life', 'laboratory tests, physical examination, vital signs, and incidence of adverse events (AEs', 'geometric mean ratios (GMRs', 'values of t 1/2  and T max  for amitriptyline', 'GMRs of C max , AUC 0-t , and AUC 0-∞']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0700523', 'cui_str': 'Amitriptyline hydrochloride'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002600', 'cui_str': 'Amitriptyline'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0002600', 'cui_str': 'Amitriptyline'}]",,0.0274805,The values of t 1/2  and T max  for amitriptyline were not significantly different between the test and reference products under both fasting and fed conditions (P > 0.05).,"[{'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': ""Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ""Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Yunliang', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Minglan', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': ""Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Yujie', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': ""Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Shentu', 'Affiliation': ""Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Qingwei', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': ""Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Research Center for Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}]","Drug design, development and therapy",['10.2147/DDDT.S258173']
2330,32801651,"First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of a Neuroprotective Poly (ADP-ribose) Polymerase-1 Inhibitor, JPI-289, in Healthy Volunteers.","Background


Poly (ADP-ribose) polymerase-1 (PARP-1) inhibitor has therapeutic potential for acute ischemic stroke by suppressing microglial activation and facilitating neuroprotection. In this first-in-human study, we investigate the safety, tolerability and pharmacokinetics (PK) of JPI-289 in healthy male volunteers.
Subjects and Methods


In single ascending dose (SAD) study, 35, 75, 150, 300, 600 mg JPI-289 or placebo was infused intravenously over 30 minutes to 40 subjects. In multiple ascending dose (MAD) study, 150, 300, 450 mg JPI-289 or placebo was infused over 1 hour every 12 hours to each of 24 subjects for 3.5 days (7 times). The plasma and urine concentrations of JPI-289 and its metabolites were determined.
Results


In the SAD study, AUC last  and C max  tended to increase supra-proportionally especially at higher doses in SAD study. However, C max  showed dose-proportionality in the range of 75-600mg. JPI-289 reached a mean T max  within 0.50 hour after dosing and a mean elimination half-life (t 1/2 ) was 2.18 to 3.21 hours. In the MAD study, observed accumulation index ranged from 1.52 to 1.76. The effective half-life of JPI-289 was 1.88 to 3.05 hours, indicating that the plasma JPI-289 concentration rapidly reaches steady state. % recovered of JPI-289 measured in urine was 1.59-9.05%. In both studies, concentration of metabolites was less than 10% of JPI-289. Adverse events reported in the study were all mild in intensity and resolved without any sequelae.
Conclusion


The tolerable dose ranges and pharmacokinetic characteristics of JPI-289 evaluated in these studies will be useful in further clinical development of JPI-289.",2020,"In the SAD study, AUC last  and C max  tended to increase supra-proportionally especially at higher doses in SAD study.","['Healthy Volunteers', 'healthy male volunteers', 'Subjects and Methods']","['JPI-289 or placebo', 'Neuroprotective Poly (ADP-ribose) Polymerase-1 Inhibitor, JPI-289', '\n\n\nPoly (ADP-ribose) polymerase-1', 'JPI-289']","['Adverse events', 'JPI-289 reached a mean T max', 'JPI-289 measured in urine', 'safety, tolerability and pharmacokinetics (PK', 'concentration of metabolites', 'plasma and urine concentrations of JPI-289 and its metabolites', 'Safety, Tolerability, and Pharmacokinetics', 'plasma JPI-289 concentration rapidly reaches steady state']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C4548885', 'cui_str': 'JPI-289'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1567710', 'cui_str': 'PARP1 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4548885', 'cui_str': 'JPI-289'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.0291443,"In the SAD study, AUC last  and C max  tended to increase supra-proportionally especially at higher doses in SAD study.","[{'ForeName': 'Sungpil', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yo Han', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hee Youn', 'Initials': 'HY', 'LastName': 'Choi', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dong-Jun', 'Initials': 'DJ', 'LastName': 'Soh', 'Affiliation': 'Clinical Development Team, Jeil Pharmaceutical Co. Ltd, Seoul, Republic of Korea.'}, {'ForeName': 'Jeongmin', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Clinical Development Team, Jeil Pharmaceutical Co. Ltd, Seoul, Republic of Korea.'}, {'ForeName': 'Joonwoo', 'Initials': 'J', 'LastName': 'Nam', 'Affiliation': 'Clinical Development Team, Jeil Pharmaceutical Co. Ltd, Seoul, Republic of Korea.'}, {'ForeName': 'Jong-Woo', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Clinical Development Team, Jeil Pharmaceutical Co. Ltd, Seoul, Republic of Korea.'}, {'ForeName': 'Kyun-Seop', 'Initials': 'KS', 'LastName': 'Bae', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyeong-Seok', 'Initials': 'HS', 'LastName': 'Lim', 'Affiliation': 'Department of Clinical Pharmacology and Therapeutics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}]","Drug design, development and therapy",['10.2147/DDDT.S235802']
2331,32801768,Clinical Evaluation of the Safety and Efficacy of Trifluridine/Tipiracil in the Treatment of Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: Evidence to Date.,"Trifluridine/tipiracil or TAS-102 (Taiho Oncology, Lonsurf ® , Princeton, NJ, USA) is a combination tablet of trifluridine, a thymidine-based nucleoside analog, and tipiracil, a thymidine phosphorylase inhibitor, in a 1:0.5 molar ratio. This drug was first approved for use in metastatic colorectal cancer patients. Recently, the U S Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted approval of trifluridine/tipiracil for treatment of metastatic gastric and gastroesophageal junction adenocarcinoma in patients following at least two lines of chemotherapy including fluoropyrimidine and platinum chemotherapy agents, as well as taxanes or irinotecan. This approval was granted after the findings from first a Phase II trial (EPOC1201) investigating trifluridine/tipiracil, and later a global Phase III trial (TAGS trial) that compared trifluridine/tipiracil vs placebo with best supportive care. Both trials primarily utilized trifluridine/tipiracil at a dose of 35 mg/m 2  twice daily. In the EPOC1201 trial, the primary end point of disease control rate was greater than 50% after eight weeks of therapy. The most common grade three or four adverse event was neutropenia; additional toxicities included leukopenia, anemia, and anorexia. In the TAGS trial, overall survival in patients treated with trifluridine/tipiracil (5.7 months) was significantly improved as compared to the placebo-controlled group (3.6 months). Treatment with trifluridine/tipiracil not only did not impair quality of life but also tended to reduce the risk of deterioration of quality of life. The results of these studies along with the subsequent FDA and EMA approval have generated an important breakthrough in regard to treatment options for patients with refractory metastatic gastric or gastroesophageal junction adenocarcinoma.",2020,"The most common grade three or four adverse event was neutropenia; additional toxicities included leukopenia, anemia, and anorexia.","['metastatic colorectal cancer patients', 'Advanced Gastric/Gastroesophageal Junction Adenocarcinoma', 'patients with refractory metastatic gastric or gastroesophageal junction adenocarcinoma']","['Trifluridine/tipiracil or TAS-102', 'fluoropyrimidine and platinum chemotherapy agents', 'taxanes or irinotecan', 'Trifluridine/Tipiracil', 'trifluridine/tipiracil', 'trifluridine/tipiracil vs placebo', 'placebo']","['quality of life', 'disease control rate', 'risk of deterioration of quality of life', 'overall survival', 'neutropenia; additional toxicities included leukopenia, anemia, and anorexia']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C1332166', 'cui_str': 'Adenocarcinoma of the gastroesophageal junction'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}]","[{'cui': 'C4055631', 'cui_str': 'Tipiracil- and trifluridine-containing product'}, {'cui': 'C1451803', 'cui_str': 'TAS-102'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}]",,0.0939946,"The most common grade three or four adverse event was neutropenia; additional toxicities included leukopenia, anemia, and anorexia.","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Wheelden', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Penn State Health Milton S. Hershey Medical Center, Hershey, PA, USA.'}, {'ForeName': 'Nelson S', 'Initials': 'NS', 'LastName': 'Yee', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Penn State Health Milton S. Hershey Medical Center, Hershey, PA, USA.'}]",OncoTargets and therapy,['10.2147/OTT.S216598']
2332,32801784,Serum Exosomal miR-1290 is a Potential Biomarker for Lung Adenocarcinoma.,"Purpose


Lung cancer is a leading cause of cancer-related death, with lung adenocarcinoma (LUAD) representing the most common subtype. Recently, exosome-based biomarkers have provided new diagnostic approaches for malignancies. We aimed to identify specific exosomal microRNAs (miRNAs) as noninvasive biomarkers for LUAD.
Patients and Methods


A total of 110 participants were enrolled and randomly divided into two sets: the discovery set (n=20) and the validation set (n=90). Exosomes were isolated from serum, and miRNAs were subsequently extracted. Candidate miRNAs (miR-21, miR-221-3p, miR-222-3p, miR-223, miR-638 and miR-1290) were detected by quantitative real-time PCR (qRT-PCR) in the discovery set. The upregulated miR-1290 was then selected for further analysis in the validation set along with three tumor markers (CEA, CYFRA21-1 and NSE). The diagnostic and prognostic value of exosomal miR-1290 were estimated through receiver-operating characteristic (ROC) and survival analysis.
Results


Serum exosomal miR-1290 was significantly upregulated in LUAD patients compared to healthy controls (P<0.001) and decreased after resection (P=0.0029). Its expression level was associated with tumor stage, tumor size, lymph node and distant metastasis (all P <0.05). Exosomal miR-1290 had a higher diagnostic efficacy than CEA, CYFRA21-1 and NSE, with a sensitivity of 80.0% and specificity of 96.7% (AUC: 0.937, 95% CI: 0.890-0.985; P<0.001). Moreover, LUAD patients with a high level of exosomal miR-1290 had significantly poorer progression-free survival (PFS) than those with a low level of exosomal miR-1290 (mean PFS: 14 months vs 37 months, P<0.001). Cox proportional hazards model analysis demonstrated that exosomal miR-1290 could be an independent risk factor for the prognosis of LUAD (HR=7.80, P=0.017).
Conclusion


Serum exosomal miR-1290 could be a potential diagnostic and prognostic biomarker for LUAD.",2020,"Exosomal miR-1290 had a higher diagnostic efficacy than CEA, CYFRA21-1 and NSE, with a sensitivity of 80.0% and specificity of 96.7% (AUC: 0.937, 95% CI: 0.890-0.985; P<0.001).",['Patients and Methods\n\n\nA total of 110 participants'],[],"['progression-free survival (PFS', 'tumor stage, tumor size, lymph node and distant metastasis', 'diagnostic efficacy', 'Serum exosomal miR-1290']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517536', 'cui_str': '110'}]",[],"[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0475455', 'cui_str': 'T - Tumor stage'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C1269798', 'cui_str': 'pM category'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}]",110.0,0.0585388,"Exosomal miR-1290 had a higher diagnostic efficacy than CEA, CYFRA21-1 and NSE, with a sensitivity of 80.0% and specificity of 96.7% (AUC: 0.937, 95% CI: 0.890-0.985; P<0.001).","[{'ForeName': 'Yining', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': ""Department of Laboratory Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, People's Republic of China.""}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': ""Department of Laboratory Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Laboratory Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, People's Republic of China.""}, {'ForeName': 'Mengxiao', 'Initials': 'M', 'LastName': 'Xie', 'Affiliation': ""Department of Laboratory Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, People's Republic of China.""}, {'ForeName': 'Xueying', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Laboratory Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Laboratory Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, People's Republic of China.""}]",OncoTargets and therapy,['10.2147/OTT.S263934']
2333,32801790,"Ribaxamase, an Orally Administered β-Lactamase, Diminishes Changes to Acquired Antimicrobial Resistance of the Gut Resistome in Patients Treated with Ceftriaxone.","Introduction


Intravenous (IV) β-lactam antibiotics, excreted through bile into the gastrointestinal (GI) tract, may disrupt the gut microbiome by eliminating the colonization resistance from beneficial bacteria. This increases the risk for  Clostridium difficile  infection (CDI) and can promote antimicrobial resistance by selecting resistant organisms and eliminating competition by non-resistant organisms. Ribaxamase is an orally administered β-lactamase for use with IV β-lactam antibiotics (penicillins and cephalosporins) and is intended to degrade excess antibiotics in the upper GI before they can disrupt the gut microbiome and alter the resistome.
Methods


Longitudinal fecal samples (349) were collected from patients who participated in a previous Phase 2b clinical study with ribaxamase for prevention of CDI. In that previous study, patients were treated with ceftriaxone for a lower respiratory tract infection and received concurrent ribaxamase or placebo. Extracted fecal DNA from the samples was subjected to whole-genome shotgun sequencing and analyzed for the presence of antimicrobial resistance (AMR) genes by alignment of sequences against the Comprehensive Antibiotic Resistance Database. A qPCR assay was also used to confirm some of the results.
Results


Database alignment identified ~1300 acquired AMR genes and gene variants, including those encoding β-lactamases and vancomycin resistance which were significantly increased in placebo vs ribaxamase-treated patients following antibiotic exposure. qPCR corroborated the presence of these genes and supported both new acquisition and expansion of existing gene pools based on no detectable copy number or a low copy number in pre-antibiotic samples which increased post-antibiotics. Additional statistical analyses demonstrated significant correlations between changes in the gut resistome and clinical study parameters including study drug assignment and β-lactamase and vancomycin resistance gene frequency.
Discussion


These findings demonstrated that ribaxamase reduced changes to the gut resistome subsequent to ceftriaxone administration and may help limit the emergence of AMR.",2020,These findings demonstrated that ribaxamase reduced changes to the gut resistome subsequent to ceftriaxone administration and may help limit the emergence of AMR.,['Methods\n\n\nLongitudinal fecal samples (349) were collected from patients who participated in a previous Phase 2b clinical study with ribaxamase for prevention of CDI'],"['Introduction\n\n\nIntravenous (IV) β-lactam antibiotics', 'ribaxamase or placebo', 'β-lactam antibiotics (penicillins and cephalosporins', 'Ribaxamase', 'Ceftriaxone', 'ceftriaxone', 'placebo']",['encoding β-lactamases and vancomycin resistance'],"[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0282601', 'cui_str': 'Compact Disk Interactive'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0022914', 'cui_str': 'Lactam'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C3536856', 'cui_str': 'Cephalosporin antibiotic product'}, {'cui': 'C0007561', 'cui_str': 'Ceftriaxone'}]","[{'cui': 'C0752078', 'cui_str': 'Vancomycin Resistance'}]",349.0,0.0455089,These findings demonstrated that ribaxamase reduced changes to the gut resistome subsequent to ceftriaxone administration and may help limit the emergence of AMR.,"[{'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Kokai-Kun', 'Affiliation': 'Synthetic Biologics, Inc., Rockville, MD, USA.'}, {'ForeName': 'Chenxiong', 'Initials': 'C', 'LastName': 'Le', 'Affiliation': 'Synthetic Biologics, Inc., Rockville, MD, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Trout', 'Affiliation': 'Synthetic Biologics, Inc., Rockville, MD, USA.'}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Cope', 'Affiliation': 'Diversigen, Inc., Houston, TX, USA.'}, {'ForeName': 'Nadim J', 'Initials': 'NJ', 'LastName': 'Ajami', 'Affiliation': 'Diversigen, Inc., Houston, TX, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Degar', 'Affiliation': 'Diversigen, Inc., Houston, TX, USA.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Connelly', 'Affiliation': 'Synthetic Biologics, Inc., Rockville, MD, USA.'}]",Infection and drug resistance,['10.2147/IDR.S260258']
2334,32802105,"Effect of Bedtime Melatonin Administration in Patients with Type 2 Diabetes: A Triple-Blind, Placebo-Controlled, Randomized Trial.","Melatonin is widely available as over the counter product. Despite promising effects of melatonin supplementation on glycemic control, there is a significant heterogeneity between studies. The current study aimed at determining the effect of melatonin on fasting blood glucose (FBG), insulin resistance/sensitivity indices, glycosylated hemoglobin A1c (HbA1c), and high sensitivity C-reactive protein (hs-CRP) among type 2 diabetes mellitus (T2D) population during 8 weeks in a randomized, triple-blind, placebo-controlled trial. Thirty four subjects with the mean age ± standard deviation of 57.74 ± 8.57 years and 36 subjects with the mean age of 57.61 ± 9.11 years were allocated to 6 mg nightly melatonin and placebo groups, respectively. Melatonin and placebo groups were matched by age, gender, body mass index, and duration of diabetes. Also, there was no significant difference in laboratory findings except for HbA1c, which was lower in the placebo group (7.00 ± 0.89% vs 7.60 ± 1.47%,  P =0.042). After trial completion, the increase of serum levels of melatonin was greater in the intervention than the placebo group (3.38 ± 1.33 vs 0.94 ± 1.28 ng/L,  P =0.192). Moreover, compared to placebo group, among melatonin users, homeostasis model assessment of insulin resistance (HOMA1-IR) tended to be unfavorable at the end of follow-up [-0.51 (-1.76-0.81) vs. 0.28 (-1.24-1.74),  P =0.20]; the similar trend was also shown for insulin sensitivity index (HOMA1-S) [2.33 (-3.59-12.46) vs. -2.33 (-10.61-9.16),  P =0.148]. No differences were observed in FBG, HbA1C, and hs-CRP changes between the trial groups. The current study did not support the improving effect of melatonin on glucose homeostasis.",2019,"Also, there was no significant difference in laboratory findings except for HbA1c, which was lower in the placebo group (7.00 ± 0.89% vs 7.60 ± 1.47%,  P =0.042).","['Thirty four subjects with the mean age ± standard deviation of 57.74 ± 8.57 years and 36 subjects with the mean age of 57.61 ± 9.11 years', 'Patients with Type 2 Diabetes']","['melatonin supplementation', 'Bedtime Melatonin Administration', 'Placebo', 'Melatonin and placebo', 'Melatonin', 'melatonin and placebo', 'melatonin', 'placebo']","['FBG, HbA1C, and hs-CRP changes', 'glucose homeostasis', 'insulin sensitivity index (HOMA1-S', 'serum levels of melatonin', 'fasting blood glucose (FBG), insulin resistance/sensitivity indices, glycosylated hemoglobin A1c (HbA1c), and high sensitivity C-reactive protein (hs-CRP', 'homeostasis model assessment of insulin resistance (HOMA1-IR']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0521112', 'cui_str': 'Bedtime'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}]",34.0,0.426641,"Also, there was no significant difference in laboratory findings except for HbA1c, which was lower in the placebo group (7.00 ± 0.89% vs 7.60 ± 1.47%,  P =0.042).","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Farrokhian', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran .'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tohidi', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran .'}, {'ForeName': 'Noushin Sadat', 'Initials': 'NS', 'LastName': 'Ahanchi', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran .'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Khalili', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran .'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Niroomand', 'Affiliation': 'Internal Medicine Department, Endocrinology Division, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Mahboubi', 'Affiliation': 'Food Safety Research Center, Department of Pharmaceutics, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran .'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Derakhshi', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran .'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Abbasinazari', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran .'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Hadaegh', 'Affiliation': 'Prevention of Metabolic Disorders Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran .'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2019.112011.13485']
2335,32802106,Comparison of Intravenous Ampicillin-sulbactam Plus Nebulized Colistin with Intravenous Colistin Plus Nebulized Colistin in Treatment of Ventilator Associated Pneumonia Caused by Multi Drug Resistant  Acinetobacter Baumannii:  Randomized Open Label Trial.,"The purpose of this study was evaluating the efficacy and safety of intravenous (IV) ampicillin-sulbactam plus nebulized colistin in the treatment of Ventilator-Associated Pneumonia (VAP) caused by MDR  Acinetobacter  (MDRA) in ICU patients as an alternative to IV plus nebulized colistin. In this single-blinded RCT, one group received IV colistin and another group IV ampicillin-sulbactam (16 and 12 patients from total 28 patients, respectively) for 14 days or since clinical response. Both groups received nebulized colistin by mesh nebulizer. There were no statistically significant differences between the 2 groups in baseline characteristics and previous antibiotic therapy. In follow up period, no significant difference was observed between 2 groups in rate of microbiological eradication, clinical signs of VAP improvement, survival rate and length of hospital as well as ICU stays. Although we have found no significant differences in Acute Kidney Injury (AKI) incidence between two groups, comparison of cumulative patient-days with stages 2 and 3 AKI with days with no or stage 1 AKI, according to AKIN criteria, revealed significant difference in IV colistin versus IV ampicillin-sulbactam group ( p  = 0.013). The results demonstrated that the high dose IV ampicillin-sulbactam plus nebulized colistin regimen has comparable efficacy with IV plus nebulized colistin in the treatment of VAP caused by MDRA, with sensitivity to colistin only, with probably lower incidence of kidney injury.",2019,"In follow up period, no significant difference was observed between 2 groups in rate of microbiological eradication, clinical signs of VAP improvement, survival rate and length of hospital as well as ICU stays.",[],"['nebulized colistin by mesh nebulizer', 'Intravenous Ampicillin', 'IV colistin and another group IV ampicillin-sulbactam', 'Multi Drug Resistant', 'intravenous (IV) ampicillin-sulbactam plus nebulized colistin']","['efficacy and safety', 'rate of microbiological eradication, clinical signs of VAP improvement, survival rate and length of hospital as well as ICU stays', 'Ventilator Associated Pneumonia', 'Acute Kidney Injury (AKI) incidence']",[],"[{'cui': 'C0009316', 'cui_str': 'Colistin'}, {'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0027524', 'cui_str': 'Nebulizer'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002680', 'cui_str': 'Ampicillin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2930041', 'cui_str': 'sultamicillin'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",28.0,0.0368784,"In follow up period, no significant difference was observed between 2 groups in rate of microbiological eradication, clinical signs of VAP improvement, survival rate and length of hospital as well as ICU stays.","[{'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Pourheidar', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Haghighi', 'Affiliation': 'Department of Infectious Diseases, Imam Hossein Teaching and Educational Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Kouchek', 'Affiliation': 'Department of Critical Care Medicine, Imam Hossein Medical and Educational Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mir Mohammad', 'Initials': 'MM', 'LastName': 'Miri', 'Affiliation': 'Department of Critical Care Medicine, Imam Hossein Medical and Educational Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyedpouzhia', 'Initials': 'S', 'LastName': 'Shojaei', 'Affiliation': 'Department of Critical Care Medicine, Imam Hossein Medical and Educational Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Salarian', 'Affiliation': 'Department of Critical Care Medicine, Imam Hossein Medical and Educational Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Rezvan', 'Initials': 'R', 'LastName': 'Hassanpour', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sistanizad', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2019.112466.13775']
2336,32802107,The Potential Effect of Intravenous Calcitriol on the Ischemia-Reperfusion Process and Inflammatory Biomarkers in Patients Following Percutaneous Coronary Intervention (PCI).,"This study aimed to investigate the efficacy of calcitriol on Ischemia-reperfusion Injury (IRI) and inflammatory biomarkers in patients with non-ST-segment elevation acute coronary syndromes (NSTEACS) undergoing elective Percutaneous Coronary Intervention (PCI). A total of 72 patients with NSTEACS were randomly divided into two groups: (1) the calcitriol-treated group, treated with three mcg intravenous calcitriol administered before PCI (n = 36) and (2) the control-treated group (n = 36) The serum high-sensitivity C-reactive protein (hs-CRP), high-sensitivity interleukin-6 (hs-IL-6), creatinine kinase (CK)-MB and cardiac troponin I (cTnI) levels were measured before PCI and 24 h after PCI in both groups. The patients were followed up for the detection of the prevalence of major adverse cardiac events (MACE) in 180 days after PCI in both groups. Compared to pre-PCI, the serum hs-CRP, hs-IL-6, CK-MB, and cTnI levels were increased at 24 h after PCI (all  p  < 0.05) in both groups. However, change in the levels of hs-CRP and hs-IL-6 were significant ( p  = 0.04 and  p  = 0.02, respectively). Changes in the levels of CK-MB and cTnI were non-significant ( p  = 0.15 and  p  = 0.39, respectively). No MACE (death, Q wave MI, target vessel revascularization, ischemic stroke) was detected in any patient in any group during a 3-month follow-up. Administration of calcitriol in patients with non-ST-segment elevation acute coronary syndromes undergoing elective PCI can attenuate the increase in serum inflammatory biomarkers in the serum (hs-CRP and hs-IL-6) and thus decrease the inflammatory reaction caused by PCI.",2019,"No MACE (death, Q wave MI, target vessel revascularization, ischemic stroke) was detected in any patient in any group during a 3-month follow-up.","['72 patients with NSTEACS', 'patients with non-ST-segment elevation acute coronary syndromes undergoing', 'Patients Following Percutaneous Coronary Intervention (PCI', 'patients with non-ST-segment elevation acute coronary syndromes (NSTEACS) undergoing elective Percutaneous Coronary Intervention (PCI']","['calcitriol', 'calcitriol-treated group, treated with three mcg intravenous calcitriol', 'Intravenous Calcitriol', 'elective PCI']","['levels of hs-CRP and hs-IL-6', 'serum high-sensitivity C-reactive protein (hs-CRP), high-sensitivity interleukin-6 (hs-IL-6), creatinine kinase ', 'serum hs-CRP, hs-IL-6, CK-MB, and cTnI levels', 'CK)-MB and cardiac troponin I (cTnI) levels', 'Ischemia-reperfusion Injury (IRI) and inflammatory biomarkers', 'No MACE (death, Q wave MI, target vessel revascularization, ischemic stroke', 'levels of CK-MB and cTnI', 'prevalence of major adverse cardiac events (MACE', 'serum inflammatory biomarkers']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0006674', 'cui_str': 'Calcitriol'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0861151', 'cui_str': 'Q wave MI'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}]",72.0,0.041203,"No MACE (death, Q wave MI, target vessel revascularization, ischemic stroke) was detected in any patient in any group during a 3-month follow-up.","[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Dastan', 'Affiliation': 'Clinical Pharmacy Department, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Salamzadeh', 'Affiliation': 'Clinical Pharmacy Department, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Alipour-Parsa', 'Affiliation': 'Department of Cardiology, Cardiovascular Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Sharif Kashani', 'Affiliation': 'Chronic Respiratory Disease Research Center, NRTLD, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Mahdi', 'Initials': 'MM', 'LastName': 'Hashempour', 'Affiliation': 'Clinical Pharmacy Department, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2019.112469.13778']
2337,32802108,"The effect of  Glycyrrhiza glabra  L. on Primary Dysmenorrhea compared with Ibuprofen: A Randomized, Triple-Blind Controlled Trial.","Primary dysmenorrhea is a common gynecological disorder in women of reproductive age. Despite the effective conventional treatments such as nonsteroidal anti-inflammatory drugs and oral contraceptives, researchers have always been looking for alternative drugs due to the adverse effects and limited efficacy of these medications.  Glycyrrhiza glabra L. (G. glabra) , commonly known as Licorice, has been applied for a long time as a plant with multiple therapeutic potencies in Traditional Persian Medicine (TPM). This study was designed to evaluate the effect of the  G. glabra  on primary dysmenorrhea. Sixty patients with moderate and severe dysmenorrhea were randomly divided into two groups; one group received 400 mg Ibuprofen tablets every 8 h and placebo syrup and the other received 5 cc of  G. glabra  syrup two times a day and placebo tablets. The patients took the drugs from the first day of menstruation to fifth for two consequent cycles. The primary pain intensity and its changes were evaluated in each group and compared between two groups. The reduction of pain intensity was 5.85 (±3.11) in the  G. glabra  group compared with 6.92 (±1.87) in the Ibuprofen group ( p  < 0.001). No significant difference detected between the two groups ( p  = 0.151). No serious side effects were reported during the study. This study suggests that we can use  G. glabra  to relieve pain in the patients with primary dysmenorrhea; although studies with a larger sample size may lead to more comprehensive perceptions about the efficacy of  G. glabra .",2019,The reduction of pain intensity was 5.85 (±3.11) in the  G. glabra  group compared with 6.92 (±1.87) in the Ibuprofen group ( p  < 0.001).,"['Sixty patients with moderate and severe dysmenorrhea', 'primary dysmenorrhea', 'patients with primary dysmenorrhea', 'women of reproductive age']","['Ibuprofen tablets every 8 h and placebo syrup and the other received 5 cc of  G. glabra  syrup two times a day and placebo tablets', 'Glycyrrhiza glabra  L', 'Glycyrrhiza glabra L. (G. glabra', 'Ibuprofen']","['reduction of pain intensity', 'serious side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}, {'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1244695', 'cui_str': 'Ibuprofen Oral Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0458173', 'cui_str': 'Syrup'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0697105', 'cui_str': 'Glycyrrhiza glabra'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",60.0,0.0511189,The reduction of pain intensity was 5.85 (±3.11) in the  G. glabra  group compared with 6.92 (±1.87) in the Ibuprofen group ( p  < 0.001).,"[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Jafari', 'Affiliation': 'Department of traditional medicine, Faculty of Iranian Traditional Medicine, Shahid Sadoughi University of medical sciences, Yazd, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Emtiazy', 'Affiliation': 'Department of traditional medicine, Faculty of Iranian Traditional Medicine, Shahid Sadoughi University of medical sciences, Yazd, Iran.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Sohrabvand', 'Affiliation': 'Department of Obstetrics-Gynecology and Infertility, Vali-e-Asr Hospital, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Daryush', 'Initials': 'D', 'LastName': 'Talei', 'Affiliation': 'Department of Biostatistics, Medicinal Plant Research Center, Shahed University, Tehran, Iran.'}, {'ForeName': 'Laleh', 'Initials': 'L', 'LastName': 'Oveidzadeh', 'Affiliation': 'Department of traditional medicine, Faculty of Iranian Traditional Medicine, Shahid Sadoughi University of medical sciences, Yazd, Iran.'}, {'ForeName': 'Mahboobeh', 'Initials': 'M', 'LastName': 'Abrishamkar', 'Affiliation': 'Department of traditional medicine, Faculty of Iranian Traditional Medicine, Shahid Sadoughi University of medical sciences, Yazd, Iran.'}, {'ForeName': 'Mahshid', 'Initials': 'M', 'LastName': 'Meyssami', 'Affiliation': 'Department of traditional medicine, Faculty of Iranian Traditional Medicine, Shahid Sadoughi University of medical sciences, Yazd, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamalinejad', 'Affiliation': 'School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Iranian journal of pharmaceutical research : IJPR,['10.22037/ijpr.2020.1100961']
2338,32807539,Medication Education for Dosing Safety: A Randomized Controlled Trial.,"STUDY OBJECTIVE


This study sought to determine whether a brief intervention at the time of emergency department (ED) discharge can improve safe dosing of liquid acetaminophen and ibuprofen by parents or guardians.
METHODS


We performed a randomized controlled trial in the ED of parents and guardians of children 90 days to 11.9 years of age who were discharged with acetaminophen or ibuprofen, or both. Families were randomized to standard care or a teaching intervention combining lay language, simplified handouts, provision of an unmarked dosing syringe, and teach-back to confirm correct dosing. Participants were called 48 to 72 hours and 5 to 7 days after ED discharge to assess understanding of correct dosing. The primary outcome was defined as parent or guardian report of safe dosing at the time of first follow-up call. Our primary hypothesis was that the intervention would decrease the rate of error from 30% to 10% at 48- to 72-hour follow-up.
RESULTS


We enrolled 149 of 259 (58%) eligible subjects; 97 of 149 (65%) were reached at first follow-up call, of whom 35 of 97 (36%) received the intervention. Among those participants receiving the intervention, 25 of 35 (71%) were able to identify a safe dose for their child at the time of the first call compared with 28 of 62 (45%) of those in the control arm. The difference in proportions was 26% (95% confidence interval [CI] 7% to 46%). There was a 58% increase in reporting safe dosing in the intervention group compared with the control roup (relative risk 1.58; 95% CI 1.12 to 2.24), and it remained significant after adjustment for health literacy and language (adjusted relative risk 1.50; 95% CI 1.06 to 2.13).
CONCLUSIONS


A multifaceted intervention at the time of ED discharge-consisting of a simplified dosing handout, a teaching session, teach-back, and provision of a standardized dosing device-can improve parents' knowledge of safe dosing of liquid medications at 48 to 72 hours.",2020,"There was a 58% increase in reporting safe dosing in the intervention group compared with the control roup (relative risk 1.58; 95% CI 1.12 to 2.24), and it remained significant after adjustment for health literacy and language (adjusted relative risk 1.50; 95% CI 1.06 to 2.13).
","['by parents or guardians', 'We enrolled 149 of 259 (58%) eligible subjects; 97 of 149 (65%) were reached at first follow-up call, of whom 35 of 97 (36%) received the intervention', 'parents and guardians of children 90 days to 11.9 years of age who were discharged with', ' or both']","['acetaminophen or ibuprofen', 'standard care or a teaching intervention combining lay language, simplified handouts, provision of an unmarked dosing syringe, and teach-back to confirm correct dosing', 'liquid acetaminophen and ibuprofen']","['health literacy and language', 'rate of error', 'reporting safe dosing', 'parent or guardian report of safe dosing at the time of first follow-up call']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",149.0,0.136961,"There was a 58% increase in reporting safe dosing in the intervention group compared with the control roup (relative risk 1.58; 95% CI 1.12 to 2.24), and it remained significant after adjustment for health literacy and language (adjusted relative risk 1.50; 95% CI 1.06 to 2.13).
","[{'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Naureckas Li', 'Affiliation': ""Division of Pediatric Infectious Diseases, Boston Children's Hospital, Boston, MA. Electronic address: caitlin.li@childrens.harvard.edu.""}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Camargo', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faridi', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Janice A', 'Initials': 'JA', 'LastName': 'Espinola', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Bryan D', 'Initials': 'BD', 'LastName': 'Hayes', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA; Department of Pharmacy, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Porter', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH; Division of Emergency Medicine, Cincinnati Children's Hospital, Cincinnati, OH.""}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Samuels-Kalow', 'Affiliation': 'Department of Emergency Medicine, Massachusetts General Hospital, Boston, MA.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.07.007']
2339,32807615,"Early complications in delayed breast reconstruction: A prospective, randomized study comparing different reconstructive methods in radiated and non-radiated patients.","BACKGROUND


There is little high-quality scientific evidence identifying the best and safest methods for delayed breast reconstruction, with most previous studies retrospective in nature. The primary aim was to compare early complication rates for two different breast-reconstructive methods in radiated and non-radiated patients, using a validated scale. The secondary aim was to identify predictors for complications.
MATERIALS AND METHODS


This study represents a clinical, randomized, prospective trial (ClinicalTrials.Gov identifier: NCT03963427), where the patients were divided into two study arms: non-radiated and radiated. In the non-radiated arm, patients were randomized to a one-stage lateral thoracodorsal flap with an implant or two-stage expander reconstruction. In the radiated arm, patients were randomized to a latissimus dorsi reconstruction combined with an implant or deep inferior epigastric artery perforator (DIEP) reconstruction. All adverse events were classified according to Clavien-Dindo and summarization of overall morbidity was performed by calculating the Comprehensive Complication Index score. The study was conducted from 2008 to 2020.
RESULTS


The complication frequencies were similar for the two surgical methods within each arm. In the non-radiated arm, risk factors for any complication were any comorbidities, and in the radiated arm, factors were a high body mass index and a contralateral operation.
CONCLUSIONS


The usage of the Clavien-Dindo scale in reconstructive surgery is feasible, but further validation is needed. In non-radiated patients, the frequencies of short-term complications were similar for lateral thoracodorsal flap and expander reconstruction, whereas in radiated patients, they were similar for DIEP and latissimus dorsi. The complication profile of the methods varied.",2020,"In non-radiated patients, the frequencies of short-term complications were similar for lateral thoracodorsal flap and expander reconstruction, whereas in radiated patients, they were similar for DIEP and latissimus dorsi.","['2008 to 2020', 'radiated and non-radiated patients', 'delayed breast reconstruction']","['latissimus dorsi reconstruction combined with an implant or deep inferior epigastric artery perforator (DIEP) reconstruction', 'one-stage lateral thoracodorsal flap with an implant or two-stage expander reconstruction']","['early complication rates', 'complication frequencies', 'Comprehensive Complication Index score', 'frequencies of short-term complications']","[{'cui': 'C0332301', 'cui_str': 'Radiating to'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}]","[{'cui': 'C0224362', 'cui_str': 'Structure of latissimus dorsi muscle'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0226401', 'cui_str': 'Structure of inferior epigastric artery'}, {'cui': 'C0182209', 'cui_str': 'Perforator'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0038925', 'cui_str': 'Flap'}]","[{'cui': 'C0231243', 'cui_str': 'Early complication'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",,0.0709844,"In non-radiated patients, the frequencies of short-term complications were similar for lateral thoracodorsal flap and expander reconstruction, whereas in radiated patients, they were similar for DIEP and latissimus dorsi.","[{'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Brorson', 'Affiliation': 'Department of Plastic Surgery, University of Gothenburg, The Sahlgrenska Academy, Institute of Clinical Sciences, Sahlgrenska University Hospital, Gothenburg, Sweden. Electronic address: fredrik.brorson@vgregion.se.'}, {'ForeName': 'Andri', 'Initials': 'A', 'LastName': 'Thorarinsson', 'Affiliation': 'Department of Plastic Surgery, University of Gothenburg, The Sahlgrenska Academy, Institute of Clinical Sciences, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kölby', 'Affiliation': 'Department of Plastic Surgery, University of Gothenburg, The Sahlgrenska Academy, Institute of Clinical Sciences, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Elander', 'Affiliation': 'Department of Plastic Surgery, University of Gothenburg, The Sahlgrenska Academy, Institute of Clinical Sciences, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hansson', 'Affiliation': 'Department of Plastic Surgery, University of Gothenburg, The Sahlgrenska Academy, Institute of Clinical Sciences, Sahlgrenska University Hospital, Gothenburg, Sweden. Electronic address: emma.hansson.2@gu.se.'}]",European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology,['10.1016/j.ejso.2020.07.010']
2340,32807632,Effects of cognitive behavioral therapy on sleep disturbances and quality of life among adults with type 2 diabetes mellitus: A randomized controlled trial.,"BACKGROUND AND AIMS


Cognitive behavioral therapy (CBT) is recommended as the first-line nonpharmacotherapy for sleep complaints. However, there are no studies that tested CBT for improving sleep quality and increasing quality of life (QOL) in patients with type 2 diabetes mellitus (T2DM). Therefore, this study aims to test the effect of CBT on sleep disturbances and QOL in patients with T2DM.
METHODS AND RESULTS


In total, 187 participants with T2DM and comorbid poor sleep quality were included in the analysis with the control group of 93 receiving usual care (UC) only and the intervention group of 94 receiving CBT with aerobic exercise plus UC, The Pittsburgh Sleep Quality Index (PSQI), the Diabetes-Specific Quality of Life Scale (DSQLS) and the glycated hemoglobin (HbA1C) values were collected at baseline, after the 2-month intervention, and 6 months of follow-up. The CBT group had 3.03 points lower PSQI scores (95% confidence interval [CI]: 2.07-4.00, P < 0.001) and 7.92 points lower total DSQLS scores (95% CI: 4.98-10.87, P < 0.001) than the control group after 6-month follow-up. No difference was found in HbAlc between the two groups (t = -0.47, P = 0.64) after 2-month intervention, while the CBT group had 0.89 units lower HbAlc (95% CI: 0.49-1.28, P < 0.001) than the control group after 6-month follow-up.
CONCLUSION


CBT is effective for sleep disturbances and can also improve sleep quality, increase QOL, and decrease glycemic levels in participants with T2DM.
TRIAL REGISTRATION


Chinese Clinical Trials Registration (Practical study of the appropriate technique for improvement of quality of life of the patients with type 2 diabetes in communities: ChiCTR-IOP-16008045).",2020,"The CBT group had 3.03 points lower PSQI scores (95% confidence interval [CI]: 2.07-4.00, P < 0.001) and 7.92 points lower total DSQLS scores (95% CI: 4.98-10.87, P < 0.001) than the control group after 6-month follow-up.","['187 participants with T2DM and comorbid poor sleep quality were included in the analysis with the control group of 93 receiving usual care (UC) only and the intervention group of 94 receiving', 'adults with type 2 diabetes mellitus', 'participants with T2DM', 'patients with type 2 diabetes mellitus (T2DM', 'patients with T2DM', 'patients with type 2 diabetes in communities']","['Cognitive behavioral therapy (CBT', 'CBT', 'cognitive behavioral therapy', 'CBT with aerobic exercise plus UC']","['glycemic levels', 'quality of life', 'sleep disturbances and QOL', 'PSQI scores', 'Pittsburgh Sleep Quality Index (PSQI), the Diabetes-Specific Quality of Life Scale (DSQLS) and the glycated hemoglobin (HbA1C) values', 'quality of life (QOL', 'total DSQLS scores', 'sleep disturbances and quality of life', 'sleep quality, increase QOL', 'sleep quality', 'HbAlc']","[{'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",187.0,0.0901047,"The CBT group had 3.03 points lower PSQI scores (95% confidence interval [CI]: 2.07-4.00, P < 0.001) and 7.92 points lower total DSQLS scores (95% CI: 4.98-10.87, P < 0.001) than the control group after 6-month follow-up.","[{'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': ""Department of Psychiatry, Xuzhou Oriental People's Hospital, 379 Tongshan Road, Xuzhou, Jiangsu, 221004, China. Electronic address: 2783369510@qq.com.""}, {'ForeName': 'Zongmei', 'Initials': 'Z', 'LastName': 'Dong', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China. Electronic address: dzm1001@126.com.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Department of Psychiatry, Xuzhou Oriental People's Hospital, 379 Tongshan Road, Xuzhou, Jiangsu, 221004, China. Electronic address: 11754214@qq.com.""}, {'ForeName': 'Pan', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China. Electronic address: xzzhangpan@126.com.'}, {'ForeName': 'Guiqiu', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China. Electronic address: 1548857561@qq.com.'}, {'ForeName': 'Quanyong', 'Initials': 'Q', 'LastName': 'Xiang', 'Affiliation': 'Department of Non-Communicable Disease Control, Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu, 210009, China. Electronic address: quanyongxiang@vip.sina.com.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Department of Psychiatry, Xuzhou Oriental People's Hospital, 379 Tongshan Road, Xuzhou, Jiangsu, 221004, China. Electronic address: 610492837@qq.com.""}, {'ForeName': 'Jinyi', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Non-Communicable Disease Control, Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu, 210009, China. Electronic address: 158694402@qq.com.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Qiao', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China.'}, {'ForeName': 'Yongjie', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Psychiatry, Xuzhou Oriental People's Hospital, 379 Tongshan Road, Xuzhou, Jiangsu, 221004, China. Electronic address: yyand4824@hotmail.com.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Department of Non-Communicable Disease Control, Jiangsu Provincial Center for Disease Control and Prevention, 172 Jiangsu Road, Nanjing, Jiangsu, 210009, China. Electronic address: qinyu@jscdc.cn.'}, {'ForeName': 'Peian', 'Initials': 'P', 'LastName': 'Lou', 'Affiliation': 'Department of Control and Prevention of Chronic Non-Communicable Diseases, Xuzhou Center for Disease Control and Prevention, 142 West Erhuan Road, Xuzhou, Jiangsu, 221006, China. Electronic address: lpa82835415@126.com.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.06.024']
2341,32807654,Phase II Study of Immunotherapy With Tecemotide and Bevacizumab After Chemoradiation in Patients With Unresectable Stage III Non-Squamous Non-Small-Cell Lung Cancer (NS-NSCLC): A Trial of the ECOG-ACRIN Cancer Research Group (E6508).,"INTRODUCTION


Although chemoradiotherapy (CRT) is the standard of care for patients with unresectable stage III non-small-cell lung cancer (LA-NSCLC), most patients relapse. Tecemotide is a MUC1 antigen-specific cancer immunotherapy vaccine. Bevacizumab improves survival in advanced nonsquamous (NS)-NSCLC and has a role in immune modulation. This phase II trial tested the combination of tecemotide and bevacizumab following CRT in patients with LA-NSCLC.
PATIENTS AND METHODS


Subjects with stage III NS-NSCLC suitable for CRT received carboplatin/paclitaxel weekly + 66 Gy followed by 2 cycles of consolidation carboplatin/paclitaxel ≤ 4 weeks of completion of CRT (Step 1). Patients with partial response/stable disease after consolidation therapy were registered onto step 2, which was 6 weekly tecemotide injections followed by every 6 weekly injections and bevacizumab every 3 weeks for up to 34 doses. The primary endpoint was to determine the safety of this regimen.
RESULTS


Seventy patients were enrolled; 68 patients (median age, 63 years; 56% male; 57% stage IIIA) initiated therapy, but only 39 patients completed CRT and consolidation therapy per protocol, primarily owing to disease progression or toxicity. Thirty-three patients (median age, 61 years; 58% male; 61% stage IIIA) were registered to step 2 (tecemotide + bevacizumab). The median number of step 2 cycles received was 11 (range, 2-25). Step 2 worst toxicity included grade 3, N = 9; grade 4, N = 1; and grade 5, N = 1. Grade 5 toxicity in step 2 was esophageal perforation attributed to bevacizumab. Among the treated and eligible patients (n = 32) who were treated on step 2, the median overall survival was 42.7 months (95% confidence interval, 21.7-63.3 months), and the median progression-free survival was 14.9 months (95% confidence interval, 11.0-20.9 months) from step 1 registration.
CONCLUSIONS


This cooperative group trial met its endpoint, demonstrating tolerability of bevacizumab + tecemotide after CRT and consolidation. In this selected group of patients, the median progression-free survival and overall survival are encouraging. Given that consolidation immunotherapy is now a standard of care following CRT in patients with LA-NSCLC, these results support a role for continued investigation of antiangiogenic and immunotherapy combinations in LA-NSCLC.",2020,"Among the treated and eligible patients (n = 32) who were treated on step 2, the median overall survival was 42.7 months (95% confidence interval, 21.7-63.3 months), and the median progression-free survival was 14.9 months (95% confidence interval, 11.0-20.9 months) from step 1 registration.
","['Patients with partial response/stable disease after consolidation therapy', 'Seventy patients were enrolled; 68 patients (median age, 63 years; 56% male; 57% stage IIIA) initiated therapy, but only 39 patients completed CRT and consolidation therapy per protocol, primarily owing to disease progression or toxicity', 'Cancer (NS-NSCLC', 'Thirty-three patients (median age, 61 years; 58% male; 61% stage IIIA', 'patients with LA-NSCLC', 'Subjects with stage III NS-NSCLC suitable for CRT received', 'Patients With Unresectable Stage III Non-Squamous Non-Small-Cell Lung', 'patients with unresectable stage III non-small-cell lung cancer (LA-NSCLC']","['Immunotherapy With Tecemotide and Bevacizumab', 'Bevacizumab', 'tecemotide and bevacizumab', 'consolidation immunotherapy', 'chemoradiotherapy (CRT', 'carboplatin/paclitaxel weekly\xa0+ 66 Gy followed by 2 cycles of consolidation carboplatin/paclitaxel', 'bevacizumab']","['Grade 5 toxicity', 'median progression-free survival', 'safety of this regimen', 'survival', 'median progression-free survival and overall survival', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0445128', 'cui_str': 'Non-small cell'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}]","[{'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C3888078', 'cui_str': 'tecemotide'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",70.0,0.311282,"Among the treated and eligible patients (n = 32) who were treated on step 2, the median overall survival was 42.7 months (95% confidence interval, 21.7-63.3 months), and the median progression-free survival was 14.9 months (95% confidence interval, 11.0-20.9 months) from step 1 registration.
","[{'ForeName': 'Jyoti D', 'Initials': 'JD', 'LastName': 'Patel', 'Affiliation': 'Division of Hematology/Oncology, Northwestern University, Chicago, IL. Electronic address: jd-patel@northwestern.edu.'}, {'ForeName': 'Ju-Whei', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'Data Science, Dana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, MA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Carbone', 'Affiliation': 'Department of Medicine, Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Wagner', 'Affiliation': 'Department of Radiation Oncology, Penn State Cancer Institute, Hersey, PA.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Shanker', 'Affiliation': 'Department of Biochemistry and Cancer Biology, Meharry Medical College, Nashville, TN.'}, {'ForeName': 'Maria Teresa P', 'Initials': 'MTP', 'LastName': 'de Aquino', 'Affiliation': 'Department of Biochemistry and Cancer Biology, Meharry Medical College, Nashville, TN.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Department of Medicine, Vanderbilt University, Nashville, TN.'}, {'ForeName': 'Melissa L', 'Initials': 'ML', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, Sarah Cannon Research Institute, Nashville, TN.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Gerber', 'Affiliation': 'Department of Medicine, UT Southwestern/Simmons Cancer Center, Dallas, TX.'}, {'ForeName': 'Jane Jijun', 'Initials': 'JJ', 'LastName': 'Liu', 'Affiliation': 'Illinois Cancer Care, Peoria, IL.'}, {'ForeName': 'Millie S', 'Initials': 'MS', 'LastName': 'Das', 'Affiliation': 'Department of Medicine, VA Palo Alto Health Care, Palo Alto, CA.'}, {'ForeName': 'Mohammed Ali', 'Initials': 'MA', 'LastName': 'Al-Nsour', 'Affiliation': 'Mercy Cancer Centers, Toledo, OH.'}, {'ForeName': 'Christopher S R', 'Initials': 'CSR', 'LastName': 'Dakhil', 'Affiliation': 'Wichita NCORP, Wichita, KS.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Ramalingam', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, GA.'}, {'ForeName': 'Joan H', 'Initials': 'JH', 'LastName': 'Schiller', 'Affiliation': 'Inova Cancer Institute, Fairfax, VA.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.06.007']
2342,32808029,"L-Cysteine Containing Vitamin Supplement Which Prevents or Alleviates Alcohol-related Hangover Symptoms: Nausea, Headache, Stress and Anxiety.","AIMS


Alcohol-related hangover symptoms: nausea, headache, stress and anxiety cause globally considerable amount of health problems and economic losses. Many of these harmful effects are produced by alcohol and its metabolite, acetaldehyde, which also is a common ingredient in alcohol beverages. The aim of the present study is to investigate the effect of the amino acid L-cysteine on the alcohol/acetaldehyde related aftereffects.
METHODS


Voluntary healthy participants were recruited through advertisements. Volunteers had to have experience of hangover and/or headache. The hangover study was randomized, double-blind and placebo-controlled. Nineteen males randomly swallowed placebo and L-cysteine tablets. The alcohol dose was 1.5 g/kg, which was consumed during 3 h.
RESULTS


The primary results based on correlational analysis showed that L-cysteine prevents or alleviates hangover, nausea, headache, stress and anxiety. For hangover, nausea and headache the results were apparent with the L-cysteine dose of 1200 mg and for stress and anxiety already with the dose of 600 mg.
CONCLUSIONS


L-cysteine would reduce the need of drinking the next day with no or less hangover symptoms: nausea, headache, stress and anxiety. Altogether, these effects of L-cysteine are unique and seem to have a future in preventing or alleviating these harmful symptoms as well as reducing the risk of alcohol addiction.",2020,"The primary results based on correlational analysis showed that L-cysteine prevents or alleviates hangover, nausea, headache, stress and anxiety.","['Nineteen males randomly', 'Volunteers had to have experience of hangover and/or headache', 'Voluntary healthy participants were recruited through advertisements']","['L-Cysteine Containing Vitamin Supplement', 'swallowed placebo and L-cysteine tablets', 'amino acid L-cysteine', 'placebo']","['hangover symptoms: nausea, headache, stress and anxiety', 'alleviates hangover, nausea, headache, stress and anxiety', 'Hangover Symptoms: Nausea, Headache, Stress and Anxiety']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0221100', 'cui_str': 'Hangover'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}]","[{'cui': 'C0221100', 'cui_str': 'Hangover'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",19.0,0.119041,"The primary results based on correlational analysis showed that L-cysteine prevents or alleviates hangover, nausea, headache, stress and anxiety.","[{'ForeName': 'C J Peter', 'Initials': 'CJP', 'LastName': 'Eriksson', 'Affiliation': 'Department of Public Health, University of Helsinki, Yliopistonkatu 4, 00100 Helsinki, Finland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Metsälä', 'Affiliation': 'Department of Chemistry, University of Helsinki, Yliopistonkatu 4, 00100 Helsinki, Finland.'}, {'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Möykkynen', 'Affiliation': 'Department of Biosciences, University of Helsinki, Yliopistonkatu 4, 00100 Helsinki, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Mäkisalo', 'Affiliation': 'Transplantation and Liver Surgery Unit, Helsinki University Hospital, University of Helsinki, Yliopistonkatu 4, 00100 Helsinki, Finland.'}, {'ForeName': 'Olli', 'Initials': 'O', 'LastName': 'Kärkkäinen', 'Affiliation': 'School of Pharmacy, University of Eastern Finland, Yliopistonranta 1 C, 70211 Kuopio, Finland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Palmén', 'Affiliation': 'Schildts & Söderströms, Snellmaninkatu 13, 00170 Helsinki, Finland.'}, {'ForeName': 'Joonas E', 'Initials': 'JE', 'LastName': 'Salminen', 'Affiliation': 'Department of Chemistry, University of Helsinki, Yliopistonkatu 4, 00100 Helsinki, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Kauhanen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Yliopistonranta 1 C, 70211 Kuopio, Finland.'}]","Alcohol and alcoholism (Oxford, Oxfordshire)",['10.1093/alcalc/agaa082']
2343,32808147,Efficacy of high-intensity laser therapy in patients with adhesive capsulitis: a sham-controlled randomized controlled trial.,"Adhesive capsulitis is an idiopathic condition characterized by painful shoulder stiffness, impairs quality of life, and causes disability. The purpose of the study is to evaluate the effects of high-intensity laser therapy (HILT) on pain, disability, and quality of life in patients with adhesive capsulitis. The study was designed as a prospective, double-blinded, and sham-controlled randomized trial. Thirty-six patients diagnosed with adhesive capsulitis were randomized into HILT plus therapeutic exercises, sham-laser plus therapeutic exercises, and control-therapeutic exercises only groups. All groups received 25 min of exercises to the shoulder joint supervised by a physiotherapist. Patients in both the HILT and the sham-laser group were blinded to their group randomization. The interventions were performed five times a week for 3 weeks (a total of 15 sessions). The primary outcome measure was the visual analogue scale for pain (Visual Analog Scale for pain (VAS)-pain). The secondary outcome measures were shoulder pain and disability index (SPADI), short-form health survey-36 (SF-36), and range of motion (ROM) of the shoulder joint. Assessments were performed at pre-intervention, post-intervention, and 12-week follow-up by an investigator who was blinded. Thirty-one participants completed the study. HILT plus therapeutic exercises showed significant differences in VAS-pain, SPADI-pain, and SF-36 (subgroups of energy/fatigue, pain, and general health) scores (all P < 0.05). All groups provided comparable improvements in SPADI-disability and ROM of shoulder joint after the interventions and during the follow-up (all P < 0.05). Fifteen sessions of HILT are superior to improve pain and quality of life but not superior in terms of disability or function in patients with adhesive capsulitis. Clinical trial registration number: The study was registered at the US National Institutes of Health ( ClinicalTrials.gov ) (NCT03929276) and available at https://clinicaltrials.gov/ct2/show/NCT03929276?term=tu%C4%9Fba+atan&draw=2&rank=3.",2020,Fifteen sessions of HILT are superior to improve pain and quality of life but not superior in terms of disability or function in patients with adhesive capsulitis.,"['Thirty-one participants completed the study', 'Thirty-six patients diagnosed with adhesive capsulitis', 'patients with adhesive capsulitis']","['25\xa0min of exercises to the shoulder joint supervised by a physiotherapist', 'HILT', 'high-intensity laser therapy (HILT', 'HILT plus therapeutic exercises, sham-laser plus therapeutic exercises, and control-therapeutic exercises only groups', 'high-intensity laser therapy']","['pain and quality of life', 'VAS-pain, SPADI-pain, and SF-36 (subgroups of energy/fatigue, pain, and general health) scores', 'Efficacy', 'shoulder pain and disability index (SPADI), short-form health survey-36 (SF-36), and range of motion (ROM) of the shoulder joint', 'SPADI-disability and ROM of shoulder joint', 'pain, disability, and quality of life', 'visual analogue scale for pain (Visual Analog Scale for pain (VAS)-pain']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}]",36.0,0.1268,Fifteen sessions of HILT are superior to improve pain and quality of life but not superior in terms of disability or function in patients with adhesive capsulitis.,"[{'ForeName': 'Tuğba', 'Initials': 'T', 'LastName': 'Atan', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Gaziler Physical Therapy and Rehabilitation Education and Research Hospital, Ankara, Turkey. tubaatan@gmail.com.'}, {'ForeName': 'Yeliz', 'Initials': 'Y', 'LastName': 'Bahar-Ozdemir', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Health Sciences University Sultan Abdulhamid Han Training and Research Hospital, Selimiye, Tıbbiye Caddesi, 34668, Uskudar, İstanbul, Turkey.'}]",Lasers in medical science,['10.1007/s10103-020-03121-z']
2344,32808151,Sibling Configuration as a Moderator of the Effectiveness of a Theory of Mind Training in Children with Autism: a Randomized Controlled Trial.,"This RCT investigated whether participants' sibling configuration moderated the effect of a Theory of Mind (ToM) intervention for children with autism. Children with autism aged 8-13 years (n = 141) were randomized over a waitlist control or treatment condition. Both having more siblings, as well as having an older sibling were related to better outcomes on measures of ToM-related behavior and social cognition, but not ToM knowledge or autistic features in general. The finding that these associations were limited to practical skills addressed in the intervention, seems to indicate that having more siblings and having an older sibling provides enhanced opportunities for children with autism to practice taught skills in the home environment.",2020,"Both having more siblings, as well as having an older sibling were related to better outcomes on measures of ToM-related behavior and social cognition, but not ToM knowledge or autistic features in general.","['children with autism', 'Children with Autism', 'Children with autism aged 8-13\xa0years (n\u2009=\u2009141']","['Mind Training', 'Theory of Mind (ToM) intervention', 'waitlist control or treatment condition']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517572', 'cui_str': '141'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],141.0,0.026542,"Both having more siblings, as well as having an older sibling were related to better outcomes on measures of ToM-related behavior and social cognition, but not ToM knowledge or autistic features in general.","[{'ForeName': 'Danielle M J', 'Initials': 'DMJ', 'LastName': 'de Veld', 'Affiliation': 'Netherlands Youth Institute, Utrecht, The Netherlands.'}, {'ForeName': 'Anke M', 'Initials': 'AM', 'LastName': 'Scheeren', 'Affiliation': 'Section Clinical Developmental Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Howlin', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience King's College, London, UK.""}, {'ForeName': 'Elske', 'Initials': 'E', 'LastName': 'Hoddenbach', 'Affiliation': 'De Bascule, Duivendrecht, The Netherlands.'}, {'ForeName': 'Fleur', 'Initials': 'F', 'LastName': 'Mulder', 'Affiliation': 'Section Clinical Developmental Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Imke', 'Initials': 'I', 'LastName': 'Wolf', 'Affiliation': 'Section Clinical Developmental Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Begeer', 'Affiliation': 'Section Clinical Developmental Psychology, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands. S.Begeer@vu.nl.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04649-3']
2345,32808163,"A Phase 4, Open-Label, Single-Arm Study Assessing the Efficacy and Safety of Ivabradine in African American Patients with Heart Failure and Reduced Ejection Fraction.","INTRODUCTION


There are limited data on ivabradine therapy in black patients and none in African Americans. We performed an open-label, prospective study at two centers in the United States. African American patients with heart failure (HF) (N = 30), left ventricular ejection fraction ≤ 35%, and in sinus rhythm with resting heart rate (HR) ≥ 70 bpm received ivabradine 2.5-7.5 mg twice daily for 57 days.
METHODS


The primary endpoint was change in HR from baseline to day 57, compared with the -5 bpm change observed in the absence of ivabradine in the placebo group of the SHIFT study. The safety endpoint was treatment-emergent adverse events (TEAEs). Exploratory endpoints were change from baseline to day 57 in 6-minute walk test (6MWT) distance, HR difference during a 6MWT (i.e. HR at minute 6 - resting HR), and physical activity counts.
RESULTS


At day 57, the estimated least squares mean change from baseline in HR was -9.5 bpm (95% CI -13.0, -6.0). The estimated mean treatment difference with ivabradine versus a presumed -5 bpm change from baseline HR, as seen in the placebo group of the SHIFT study, was -4.5 bpm (95% CI -8.0, -1.0; p = 0.013). The mean (SE) changes in 6MWT distance and HR difference during the 6MWT were 16.3 (10.8) meters and 2.3 (3.7) bpm, respectively. Ivabradine therapy did not result in greater physical activity. TEAEs were reported in 11 (36.7%) patients.
CONCLUSION


These data support ivabradine use in African American patients with HF with reduced ejection fraction who meet typical treatment criteria.
TRIAL REGISTRATION


ClinicalTrials.gov identifier, NCT03456856.",2020,"The mean (SE) changes in 6MWT distance and HR difference during the 6MWT were 16.3 (10.8) meters and 2.3 (3.7) bpm, respectively.","['black patients and none in African Americans', 'African American Patients with Heart Failure and Reduced Ejection Fraction', 'African American patients with heart failure (HF', 'African American patients with HF with reduced ejection fraction who meet typical treatment criteria']","['ivabradine', 'Ivabradine', 'ivabradine 2.5-7.5\xa0mg twice daily for 57\xa0days', 'Ivabradine therapy']","['change in HR', 'greater physical activity', '6-minute walk test (6MWT) distance, HR difference during a 6MWT (i.e. HR at minute 6 - resting HR), and physical activity counts', 'sinus rhythm with resting heart rate (HR)\u2009≥', 'mean (SE) changes in 6MWT distance and HR difference']","[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.117285,"The mean (SE) changes in 6MWT distance and HR difference during the 6MWT were 16.3 (10.8) meters and 2.3 (3.7) bpm, respectively.","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Lanfear', 'Affiliation': 'Henry Ford Health System, Detroit, MI, USA. DLANFEA1@hfhs.org.'}, {'ForeName': 'Kelsey R', 'Initials': 'KR', 'LastName': 'Neaton', 'Affiliation': 'Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Yimeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Ricardo E', 'Initials': 'RE', 'LastName': 'Dent-Acosta', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Cardiology and therapy,['10.1007/s40119-020-00196-1']
2346,32808345,The effect of 8 weeks of freestyle swim training on the functional fitness of adults with Down syndrome.,"BACKGROUND


Studies conducted on adults with Down syndrome have demonstrated the improvement of functional fitness (aerobic capacity, muscular strength, balance, flexibility, functional ability, body mass or body mass index) with varying exercise modalities but often with one or two components in isolation. Such modalities included walking, running, cycling, rowing or resistance training. Freestyle swim training has shown significant improvements of all parameters associated with functional fitness in the general population. Swimming is an aerobic activity where many of the large muscle groups are involved and may provide more functional fitness benefits. As a consequence, the purpose of our study was to investigate the effect of freestyle swim training on the functional fitness of adults with Down syndrome.
METHODS


Twenty-six adults with Down syndrome (33 ± 6 years; 34 ± 9 kg/m 2  ) were randomly allocated to an exercise (n = 13; 81.3 kg) or control group (n = 13; 81.5 kg). The exercise group performed 8 weeks of freestyle swim training, three times a week, 30 min per session (increased to 40 min after 4 weeks). To evaluate differences between groups, a one-way analysis of variance was used, controlling for differences at baseline.
RESULTS


After 8 weeks of training, the results showed significant differences between the exercise and control group for body mass, body mass index, aerobic capacity, dynamic balance, muscular strength, 12-m swim time and functional ability (P < 0.05). Effect sizes ranged from small to large.
CONCLUSIONS


Various components of functional fitness improved significantly after an intervention period of freestyle swim training. The collective improvement of many functional fitness parameters shown by this study may hold benefits for these often-neglected and in many cases functionally impaired individuals.",2020,"After 8 weeks of training, the results showed significant differences between the exercise and control group for body mass, body mass index, aerobic capacity, dynamic balance, muscular strength, 12-m swim time and functional ability (P < 0.05).","['Twenty-six adults with Down syndrome (33\xa0±\xa06\xa0years; 34\xa0±\xa09\xa0kg/m 2  ', 'adults with Down syndrome']","['Freestyle swim training', 'walking, running, cycling, rowing or resistance training', 'exercise', 'freestyle swim training']","['functional fitness (aerobic capacity, muscular strength, balance, flexibility, functional ability, body mass or body mass index', 'functional fitness', 'body mass, body mass index, aerobic capacity, dynamic balance, muscular strength, 12-m swim time and functional ability']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",26.0,0.0259239,"After 8 weeks of training, the results showed significant differences between the exercise and control group for body mass, body mass index, aerobic capacity, dynamic balance, muscular strength, 12-m swim time and functional ability (P < 0.05).","[{'ForeName': 'P H', 'Initials': 'PH', 'LastName': 'Boer', 'Affiliation': 'Department of Human Movement Science, Faculty of Education, Cape Peninsula University of Technology, Wellington, South Africa.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12768']
2347,32808383,"Effect of a technology-supported physical activity intervention on health-related quality of life, sleep, and processes of behavior change in cancer survivors: A randomized controlled trial.","OBJECTIVES


This pilot trial tested the effect of adding a multi-level, technology-based physical activity intervention module to a standard survivorship care plan for breast and colorectal cancer survivors. The objective of this analysis was to determine whether the physical activity module improved health-related quality of life, sleep, and factors key to lasting behavior change (e.g., social support, self-efficacy).
METHODS


Breast and colorectal cancer survivors (n=50) were enrolled alongside a support partner. Survivors were assigned to receive a standard survivorship care plan either alone or augmented by a 12-week multi-component physical activity module. The module included a Fitbit tracker (with the physical activity data integrated into the electronic health record for clinician review) and customized email feedback. Physical activity was measured using the ActiGraph GT3X+. Psychosocial outcomes included the SF-36, FACT, ISEL, PROMIS sleep measures, and physical activity beliefs. Data were analyzed using linear mixed modeling.
RESULTS


Cancer survivors were aged 54.4±11.2 years and were 2.0±1.5 years from diagnosis. Relative to comparison, the intervention was associated with moderate-to-large improvements in physical health (effect size: d=0.39, 95% CI=0.0,0.78), mental health (d=0.59, 95% CI=0.19,0.99), sleep impairment (d=0.62, 95% CI=-1.02,-0.22), and exercise self-efficacy (d=0.60, 95% CI=0.20,1.0).
CONCLUSION


The intervention delivered meaningful improvements in survivors' quality of life, social support, and sleep impairment. If replicated in a larger sample, adding a technology-supported physical activity module to survivorship care plans may be a practical strategy for supporting healthy survivorship. This article is protected by copyright. All rights reserved.",2020,"Relative to comparison, the intervention was associated with moderate-to-large improvements in physical health (effect size: d=0.39, 95% CI=0.0,0.78), mental health (d=0.59, 95% CI=0.19,0.99), sleep impairment (d=0.62, 95% CI=-1.02,-0.22), and exercise self-efficacy (d=0.60, 95% CI=0.20,1.0).
","['Cancer survivors were aged 54.4±11.2\u2009years and were 2.0±1.5\u2009years from diagnosis', 'breast and colorectal cancer survivors', 'cancer survivors', 'Breast and colorectal cancer survivors (n=50) were enrolled alongside a support partner']","['technology-supported physical activity intervention', 'multi-level, technology-based physical activity intervention module to a standard survivorship care plan', 'standard survivorship care plan either alone or augmented by a 12-week multi-component physical activity module', 'Fitbit tracker (with the physical activity data integrated into the electronic health record for clinician review) and customized email feedback']","['sleep impairment', 'exercise self-efficacy', 'health-related quality of life, sleep, and processes of behavior change', 'Physical activity', 'health-related quality of life, sleep, and factors key to lasting behavior change (e.g., social support, self-efficacy', ""survivors' quality of life, social support, and sleep impairment"", 'mental health', 'SF-36, FACT, ISEL, PROMIS sleep measures, and physical activity beliefs', 'physical health']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0178916', 'cui_str': 'Care plan'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.120099,"Relative to comparison, the intervention was associated with moderate-to-large improvements in physical health (effect size: d=0.39, 95% CI=0.0,0.78), mental health (d=0.59, 95% CI=0.19,0.99), sleep impairment (d=0.62, 95% CI=-1.02,-0.22), and exercise self-efficacy (d=0.60, 95% CI=0.20,1.0).
","[{'ForeName': 'Somya', 'Initials': 'S', 'LastName': 'Rastogi', 'Affiliation': 'University of Wisconsin-, Madison.'}, {'ForeName': 'Amye J', 'Initials': 'AJ', 'LastName': 'Tevaarwerk', 'Affiliation': 'University of Wisconsin-, Madison.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Sesto', 'Affiliation': 'University of Wisconsin-, Madison.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Van Remortel', 'Affiliation': 'University of Wisconsin-, Madison.'}, {'ForeName': 'Preshita', 'Initials': 'P', 'LastName': 'Date', 'Affiliation': 'University of Wisconsin-, Madison.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Gangnon', 'Affiliation': 'University of Wisconsin-, Madison.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Thraen-Borowski', 'Affiliation': 'University of Wisconsin-, Madison.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cadmus-Bertram', 'Affiliation': 'University of Wisconsin-, Madison.'}]",Psycho-oncology,['10.1002/pon.5524']
2348,32808394,Effects of horse riding simulator on sitting motor function in children with spastic cerebral palsy.,"BACKGROUND


Horse riding simulator (HRS) is an electronic horse, working under the principles of hippotherapy. It is one of the advanced therapeutic methods to improve postural control and balance in sitting, which could be recommended in the rehabilitation of cerebral palsy if real horses are unavailable.
OBJECTIVE


To investigate the therapeutic effects of HRS on sitting motor function in children with spastic diplegia and evaluate the changes in sitting motor function at different periods of time (4, 8 and 12 weeks).
METHODS


This study is a randomized controlled trial conducted over a period of 12 weeks. Thirty children with spastic diplegia age between 2 and 4 years with Gross Motor Function Classification System (GMFCS) Level I-III were included and divided into two groups. The control group received the conventional physiotherapy while the experimental group received HRS along with conventional physiotherapy. Sitting motor function was assessed by Gross Motor Function Measure (GMFM)-88 (sitting dimension B) at baseline, 4, 8 and 12 weeks. Pre- and post-intervention scores were measured and analysed.
RESULTS


The baseline characteristics were similar in both groups before the intervention with p > .01. The observed mean value of GMFM in both groups improved over a period of 12 weeks. The results denote that the sitting motor function gradually improved over a period of time in both groups and the experimental group showed significant improvement (p < .01) than the control group in all the weeks.
CONCLUSION


The study results confirmed that gradual improvement in sitting motor function was observed in both groups. Children exposed to HRS show better improvement than the children in the control group. It was concluded that HRS is effective in improving the sitting motor function in children with spastic diplegia and the continuous provision of HRS in longer duration provide more benefits than the shorter duration.",2020,"The results denote that the sitting motor function gradually improved over a period of time in both groups and the experimental group showed significant improvement (p < .01) than the control group in all the weeks.
","['Thirty children with spastic diplegia age between 2 and 4\u2009years with Gross Motor Function Classification System (GMFCS', 'children with spastic cerebral palsy', 'children with spastic diplegia', 'Level I-III']","['horse riding simulator', 'conventional physiotherapy while the experimental group received HRS along with conventional physiotherapy', 'HRS', 'Horse riding simulator (HRS']","['sitting motor function', 'mean value of GMFM', 'Gross Motor Function Measure (GMFM)-88 (sitting dimension B', 'Sitting motor function']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023882', 'cui_str': 'Spastic diplegia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0073361', 'cui_str': 'RID'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",30.0,0.019812,"The results denote that the sitting motor function gradually improved over a period of time in both groups and the experimental group showed significant improvement (p < .01) than the control group in all the weeks.
","[{'ForeName': 'Hemachithra', 'Initials': 'H', 'LastName': 'Chinniah', 'Affiliation': 'Division of PM&R, RMMC&H, Annamalai University, Annamalai Nagar, Tamil Nadu, India.'}, {'ForeName': 'Meena', 'Initials': 'M', 'LastName': 'Natarajan', 'Affiliation': 'Division of PM&R, RMMC&H, Annamalai University, Annamalai Nagar, Tamil Nadu, India.'}, {'ForeName': 'Ramanathan', 'Initials': 'R', 'LastName': 'Ramanathan', 'Affiliation': 'Department of Paediatrics, RMMC&H, Annamalai University, Annamalai Nagar, Tamil Nadu, India.'}, {'ForeName': 'John William Felix', 'Initials': 'JWF', 'LastName': 'Ambrose', 'Affiliation': 'RMMC, Annamalai University, Annamalai Nagar, Tamil Nadu, India.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1870']
2349,32802283,Effect of Low-level Laser Therapy With Different Locations of Irradiation on Postoperative Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis: A Double-Blind Randomized Controlled Trial.,"Introduction:  This double-blind, placebo-controlled, clinical trial aimed to investigate the analgesic efficacy of low-level laser therapy (LLLT) with two different locations, and their comparison, in postoperative endodontic pain (PEP) levels in molars diagnosed with symptomatic irreversible pulpitis.  Methods:  Seventy-five patients with a molar tooth, diagnosed with symptomatic irreversible pulpitis, were divided into three groups of placebo, buccal only irradiation (BI), and buccal and lingual irradiation (BLI), with 25 cases being in each group. The participants received similar single-visit nonsurgical endodontic treatments. Then, a sham laser was used in the control group instead of LLLT. Individuals in BI and BLI groups received 80-second irradiation on the buccal surface and 80-second irradiation on each of the buccal and lingual surfaces respectively. A laser with an 808 nm wavelength, power of 100 mW, and a fiber diameter of 600 μm was used. PEP was assessed using a 0-100 mm VAS 4, 8, 24, and 48 hours after the treatment.  Results:  BLI showed a significantly higher reduction of PEP compared to placebo in all time intervals of this study. BLI was significantly more effective than BI 8 hours after the treatment. However, intragroup differences between BLI and BI groups at other time intervals and between BI and placebo groups in all time intervals were not significant. The number of taken analgesics in the BLI group was significantly lower than the placebo group and was on a statistical borderline compared to the BI group.  Conclusion:  LLLT with BLI was an effective measure as a supplement to oral analgesics in the reduction of PEP compared to the placebo.",2020,The number of taken analgesics in the BLI group was significantly lower than the placebo group and was on a statistical borderline compared to the BI group.  ,"['molars diagnosed with symptomatic irreversible pulpitis', 'Methods:  Seventy-five patients with a molar tooth, diagnosed with symptomatic irreversible pulpitis', 'Patients With Symptomatic Irreversible Pulpitis']","['LLLT', 'Low-level Laser Therapy With Different Locations of Irradiation', 'LLLT with BLI', '80-second irradiation', 'placebo, buccal only irradiation (BI), and buccal and lingual irradiation (BLI', 'low-level laser therapy (LLLT', 'placebo']","['number of taken analgesics', 'Postoperative Endodontic Pain', 'PEP', 'analgesic efficacy', 'BLI', 'postoperative endodontic pain (PEP) levels']","[{'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0040408', 'cui_str': 'Tongue structure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",75.0,0.188292,The number of taken analgesics in the BLI group was significantly lower than the placebo group and was on a statistical borderline compared to the BI group.  ,"[{'ForeName': 'Mandana', 'Initials': 'M', 'LastName': 'Naseri', 'Affiliation': 'Associate Professor, Department of Endodontics, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Asnaashari', 'Affiliation': 'Laser Application in Medical Sciences Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Moghaddas', 'Affiliation': 'Private office, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Vatankhah', 'Affiliation': ""Students' Research Committee, School of Dentistry, Shahid Beheshti University of Medical Sciences, Tehran, Iran.""}]",Journal of lasers in medical sciences,['10.34172/jlms.2020.42']
2350,32802284,Using the Hair Removal Laser in the Axillary Region and its Effect on Normal Microbial Flora.,"Introduction:  The axillary hair removal laser is one of the most often used procedures to treat unwanted hairs in that region. Employing this technology can be helpful in decreasing the bromhidrosis.  Methods:  In the present research, a clinical trial study over the effect of the hair removal laser on normal microbial flora at the axillary region is presented. The intervention group consisted of 30 women referred to the dermatologic clinic for the purpose of removing axillary hair by the alexandrite 755 nm laser and the control group consisted of 30 women referred to the same clinic for any other reasons. Both groups were evaluated for the type of bacterial strains on the first visit and after three and six months.  Results:  The results showed that the sense of sweat smell improved by about 63% after the last laser session. The frequency of all bacterial strains decreased in the intervention group except  Staphylococcus epidermidis  which was significant. In the control group, there was no significant decrement in any bacterial strains and even the prevalence of more strains including Staphylococcus aureus and  S. epidermidis  increased. Counting the mean bacterial colon showed a slight decrement of the bacterial count following the laser.  Conclusion:  The use of laser radiation, even with the aim of hair removal, can alter the microbial flora, and it can be accompanied by the improvement of the smell of sweat. The effect of the laser on different bacterial strains is quite different, which can depend on the amount of energy, the wavelength, the characteristics of the area under the laser, and also the structural properties of the membrane of the microorganism itself.",2020,"In the control group, there was no significant decrement in any bacterial strains and even the prevalence of more strains including Staphylococcus aureus and  S. epidermidis  increased.",['30 women referred to the dermatologic clinic for the purpose of removing axillary hair by the'],"['Hair Removal Laser', 'hair removal laser', 'alexandrite 755 nm laser and the control group consisted of 30 women referred to the same clinic for any other reasons', 'laser radiation']","['bacterial strains', 'sweat smell', 'frequency of all bacterial strains', 'prevalence of more strains including Staphylococcus aureus and  S. epidermidis']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205489', 'cui_str': 'Dermatologic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0221984', 'cui_str': 'Structure of hair of axilla'}]","[{'cui': 'C0587210', 'cui_str': 'Laser removal of hair'}, {'cui': 'C0675767', 'cui_str': 'alexandrite'}, {'cui': 'C4517872', 'cui_str': '755'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}]","[{'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}, {'cui': 'C0037361', 'cui_str': 'Sense of smell, function'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}]",30.0,0.0248408,"In the control group, there was no significant decrement in any bacterial strains and even the prevalence of more strains including Staphylococcus aureus and  S. epidermidis  increased.","[{'ForeName': 'Zeynab', 'Initials': 'Z', 'LastName': 'Fazel', 'Affiliation': 'Department of Dermatology, Rasol-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Majidpour', 'Affiliation': 'Antimicrobial Research Center, Institute of Immunology Infectious Diseases, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Behrangi', 'Affiliation': 'Department of Dermatology, Rasol-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Fathizadeh', 'Affiliation': 'Antimicrobial Research Center, Institute of Immunology Infectious Diseases, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Nokandeh', 'Affiliation': 'Department of Dermatology, Rasol-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Najmolsadat', 'Initials': 'N', 'LastName': 'Atefi', 'Affiliation': 'Department of Dermatology, Rasol-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Ghassemi', 'Affiliation': 'Department of Dermatology, Rasol-e-Akram Hospital, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of lasers in medical sciences,['10.34172/jlms.2020.43']
2351,32802287,Effectiveness of Low-Level Laser Irradiation in Reducing Pain and Accelerating Socket Healing After Undisturbed Tooth Extraction.,"Introduction:  This study aimed to determine the effect of low-level laser therapy (LLLT) on reducing complications following tooth extraction.  Methods:  This randomized clinical trial consisted of 40 subjects who underwent lower molar extraction. The patients were randomly assigned to 4 groups. Group 1 was irradiated with a 660 nm laser (200 mW, 30 seconds radiation to lingual, buccal and occlusal surfaces of the socket, 6 J/area). In group 2, an 810 nm laser was applied similar to group 1. In group 3, a combination of 660 and 810 nm lasers was used. The patients in group 4 served as a placebo group. LLLT was performed after 0.5-1 hour of extraction and 2 days later. The participants were asked to record pain degree using a visual analogue scale (VAS) over 7 days. The amount of wound healing was evaluated on the third and seventh days.  Results:  There was no significant difference in pain scores among the groups at any of the assessment intervals ( P  >0.05). The between-group differences in wound healing scores were small and insignificant ( P  >0.05).  Conclusion:  LLLT with 660 nm or 810 nm lasers or their combination had no greater effect than the placebo laser for reducing the complications of tooth extraction.",2020,There was no significant difference in pain scores among the groups at any of the assessment intervals ( P  >0.05).,['40 subjects who underwent lower molar extraction'],"['LLLT', 'placebo laser', 'LLLT with 660 nm or 810 nm lasers or their combination', 'Low-Level Laser Irradiation', 'low-level laser therapy (LLLT', 'placebo']","['complications of tooth extraction', 'pain scores', 'wound healing scores', 'Pain and Accelerating Socket Healing', 'pain degree using a visual analogue scale (VAS', 'wound healing']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.101139,There was no significant difference in pain scores among the groups at any of the assessment intervals ( P  >0.05).,"[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Ahrari', 'Affiliation': 'Dental Research Center, School of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Eshghpour', 'Affiliation': 'Dental Research Center, School of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Zare', 'Affiliation': 'Oral & Maxillofacial Diseases Research Center, School of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Ebrahimi', 'Affiliation': 'Department of Operative Dentistry, School of Dentistry, Islamic Azad University, Isfahan (Khorasgan/Branch), Isfahan, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Fallahrastegar', 'Affiliation': 'Dental Research Center, School of Dentistry, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Khaki', 'Affiliation': 'Private Practice, Mashhad, Iran.'}]",Journal of lasers in medical sciences,['10.34172/jlms.2020.46']
2352,32802364,A qualitative study-Patient experience of tactile massage after stroke.,"Aim


The aim was to evaluate emotional experiences of gentle skin massage, combined with regular rehabilitation in patients shortly after being diagnosed with stroke.
Design


A randomized study with two groups: standard individualized rehabilitation and tactile massage for 20 min three times per week (max nine times) or individual standardized rehabilitations.
Methods


This study applied a qualitative approach using semi-structured questions to evaluate experiences of receiving tactile massage among patients with first-time-ever stroke. The interviews lasted between 6-25 min and analysed using manifest content analysis. Data was collected between 2015-2017. This study applies to the COREQ checklist.
Results


Eight patients >18 years of age participated. The participants experienced emotional worries especially during the night hours affecting their sleep negatively. Receiving tactile massage was reported to relax and to ease worries and anxiety momentarily, during the session and for a longer period. The results also show that physical touch generates feelings of closeness. The findings will be presented in two categories:  Human touch  and  The future .",2020,"Receiving tactile massage was reported to relax and to ease worries and anxiety momentarily, during the session and for a longer period.","['patients shortly after being diagnosed with stroke', 'patients with first-time-ever stroke', 'Eight patients >18\xa0years of age participated']","['standard individualized rehabilitation and tactile massage', 'Receiving tactile massage', 'gentle skin massage, combined with regular rehabilitation', 'tactile massage']",['emotional worries'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233481', 'cui_str': 'Worried'}]",,0.0178686,"Receiving tactile massage was reported to relax and to ease worries and anxiety momentarily, during the session and for a longer period.","[{'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Seiger Cronfalk', 'Affiliation': 'Department of Nursing Red Cross University College Stockholm Sweden.'}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Åkesson', 'Affiliation': 'Division of Neurogeriatrics Department of Neurobiology, Care Sciences and Society Center for Alzheimer Research Karolinska Institutet Stockholm Sweden.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Nygren', 'Affiliation': 'R & D Unit and Rehabilitation and Primary Care Stockholms Sjukhem Foundation Stockholm Sweden.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Nyström', 'Affiliation': 'R & D Unit and Rehabilitation and Primary Care Stockholms Sjukhem Foundation Stockholm Sweden.'}, {'ForeName': 'Anna-My', 'Initials': 'AM', 'LastName': 'Strandell', 'Affiliation': 'R & D Unit and Rehabilitation and Primary Care Stockholms Sjukhem Foundation Stockholm Sweden.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Ruas', 'Affiliation': 'Department of Physiology and Pharmacology Molecular & Cellular Exercise Physiology Karolinska Institutet Stockholm Sweden.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'von Euler', 'Affiliation': 'Department of Clinical Science and Education Karolinska Institutet Stockholm Sweden.'}]",Nursing open,['10.1002/nop2.515']
2353,32802401,"Combined vitamin D, ibuprofen and glutamic acid decarboxylase-alum treatment in recent onset Type I diabetes: lessons from the DIABGAD randomized pilot trial.","Aim


Double-blind placebo-controlled intervention using glutamic acid decarboxylase (GAD)-alum, vitamin D and Ibuprofen in recent onset Type I diabetes (T1D).
Methods


64 patients (T1D since <4 months, age 10-17.99, fasting sC-peptide ≥0.12 nmol/l, GADA-positive) were randomized into Day(D) 1-90 400 mg/day Ibuprofen, D1-450 vitamin D 2000 IU/day, D15, 45 sc. 20 μg GAD-alum; as A but placebo instead of Ibuprofen; as B but 40 μg GAD-alum D15, 45; placebo.
Results


Treatment was safe and tolerable. No C-peptide preservation was observed. We observed a linear correlation of baseline C-peptide, HbA1c and insulin/per kilogram/24 h with change in C-peptide AUC at 15 months (r = -0.776, p < 0.0001).
Conclusion


Ibuprofen, vitamin D + GAD-alum did not preserve C-peptide. Treatment efficacy was influenced by baseline clinical and immunological factors and vitamin D concentration. Clinical Trial Registration: NCT01785108 (ClinicalTrials.gov).",2020,"We observed a linear correlation of baseline C-peptide, HbA1c and insulin/per kilogram/24 h with change in C-peptide AUC at 15 months (r = -0.776, p < 0.0001).
","['64 patients (T1D since <4\xa0months, age 10-17.99, fasting sC-peptide ≥0.12', '20\xa0μg']","['Ibuprofen, D1-450 vitamin D 2000', 'Ibuprofen, vitamin D + GAD-alum', 'Ibuprofen', 'glutamic acid decarboxylase (GAD)-alum, vitamin D and Ibuprofen', 'Combined vitamin D, ibuprofen and glutamic acid decarboxylase-alum treatment', 'placebo']","['baseline clinical and immunological factors and vitamin D concentration', 'safe and tolerable']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0017785', 'cui_str': 'Glutamate decarboxylase'}, {'cui': 'C0051522', 'cui_str': 'aluminum sulfate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021054', 'cui_str': 'Immunologic substance'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.533163,"We observed a linear correlation of baseline C-peptide, HbA1c and insulin/per kilogram/24 h with change in C-peptide AUC at 15 months (r = -0.776, p < 0.0001).
","[{'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Ludvigsson', 'Affiliation': 'Department of Biomedical & Clinical Sciences, Crown Princess Victoria Children´s Hospital & Div of Pediatrics, Linköping University, SE-58185, Linköping, Sweden.'}, {'ForeName': 'Indusmita', 'Initials': 'I', 'LastName': 'Routray', 'Affiliation': 'Department of Biomedical & Clinical Sciences, Division of Pediatrics, Linköping University, SE 58185 Linköping, Sweden.'}, {'ForeName': 'Sriramulu', 'Initials': 'S', 'LastName': 'Elluru', 'Affiliation': 'Department of Biomedical & Clinical Sciences, Division of Pediatrics, Linköping University, SE 58185 Linköping, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Leanderson', 'Affiliation': 'Department of Clinical & Experimental Medicine, Occupational & Environmental Medicine Center, Linköping University, Linköping S-58185, Sweden.'}, {'ForeName': 'Helena E', 'Initials': 'HE', 'LastName': 'Larsson', 'Affiliation': 'Pediatric Endocrinology, Department of Clinical Sciences Malmö, Lund University, Sweden & Department of Pediatrics, Skåne University Hospital, SE-21428 Malmö, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Rathsman', 'Affiliation': 'Sachska Pediatric Hospital, Södersjukhuset, SE-11861 Stockholm, Sweden.'}, {'ForeName': 'Ragnar', 'Initials': 'R', 'LastName': 'Hanås', 'Affiliation': 'Department of Pediatrics, NU Hospital Group, SE 45153 Uddevalla, Sweden & Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, SE 41346 Gothenburg, Sweden.'}, {'ForeName': 'Annelie', 'Initials': 'A', 'LastName': 'Carlsson', 'Affiliation': 'Pediatric Autoimmunity, Department of Clinical Sciences Lund, Lund University, Sweden, Skåne University Hospital, SE-22242 Lund, Sweden.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Ek', 'Affiliation': 'Department of Pediatrics, Hospital of Halland, SE 30233 Halmstad, Sweden.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Samuelsson', 'Affiliation': 'Department of Biomedical & Clinical Sciences, Crown Princess Victoria Children´s Hospital & Div of Pediatrics, Linköping University, SE-58185, Linköping, Sweden.'}, {'ForeName': 'Torun', 'Initials': 'T', 'LastName': 'Torbjörnsdotter', 'Affiliation': ""Department of Women & Child Health, Astrid Lindgrens Children's Hospital at Karolinska University Hospital, Karolinska Institutet, SE 17164 Stockholm, Sweden.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Åman', 'Affiliation': 'Department of Pediatrics, University Hospital, SE 70382 Örebro, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Örtqvist', 'Affiliation': ""Department of Women & Child Health, Astrid Lindgren Children's Hospital at Karolinska University Hospital, Karolinska Institutet, SE 17164\xa0Stockholm, Sweden.""}, {'ForeName': 'Karun', 'Initials': 'K', 'LastName': 'Badwal', 'Affiliation': 'Department of Internal Medicine, Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo, MI, USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Beam', 'Affiliation': 'Department of Biomedical Sciences, Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo, MI, USA.'}, {'ForeName': 'Rosaura', 'Initials': 'R', 'LastName': 'Casas', 'Affiliation': 'Department of Biomedical & Clinical Sciences, Division of Pediatrics, Linköping University, SE 58185 Linköping, Sweden.'}]",Future science OA,['10.2144/fsoa-2020-0078']
2354,32802444,Development of a nomogram for preoperative prediction of lymph node metastasis in non-small cell lung cancer: a SEER-based study.,"Background


Lymph node dissection is an important part of lung cancer surgery. Preoperational evaluation of lymph node metastases decides which dissection pattern should be chosen. The present study aimed to develop a nomogram to predict lymph node metastases on the basis of clinicopathological features of non-small cell lung cancer (NSCLC) patients.
Methods


A total of 35,138 patients diagnosed with NSCLC from 2010-2015 were selected from the Surveillance, Epidemiology, and End Results (SEER) database. Patients were randomly divided into training cohort and validation cohort. Possible risk factors were included and analyzed by logistic regression models. A nomogram was then constructed and validated.
Results


21.83% of all patients were confirmed with positive lymph node metastasis. Age at diagnosis, sex, stage, T status, tumor size, grade and laterality were identified as predicting factors for lymph node involvement. These variables were included to build the nomogram. The AUC of the model was 0.696 (95% CI, 0.617 to 0.775). The model was further validated in the validation set with AUC 0.693 (95% CI, 0.628 to 0.758). The model presented with good prediction accuracy in both training cohort and validation cohort.
Conclusions


We developed a convenient clinical prediction model for regional lymph node metastases in NSCLC patients. The nomogram will help physicians to determine which patients will receive the most benefit from lymph node dissection.",2020,"The AUC of the model was 0.696 (95% CI, 0.617 to 0.775).","['regional lymph node metastases in NSCLC patients', '35,138 patients diagnosed with NSCLC from 2010-2015 were selected from the Surveillance, Epidemiology, and End Results (SEER) database', 'non-small cell lung cancer (NSCLC) patients', 'non-small cell lung cancer']",[],['positive lymph node metastasis'],"[{'cui': 'C0332397', 'cui_str': 'pN1 category'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}]",35138.0,0.0529271,"The AUC of the model was 0.696 (95% CI, 0.617 to 0.775).","[{'ForeName': 'Chufan', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Departmemt of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Song', 'Affiliation': 'Departmemt of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Lanlin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Departmemt of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Departmemt of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",Journal of thoracic disease,['10.21037/jtd-20-601']
2355,32802492,Effect of Music on Patient Experience during Intravitreal Injection.,"Introduction


Many patients remain anxious during intravitreal injections, despite its increasing use. As music can alleviate anxiety for other procedures, we wanted to evaluate its effect during intravitreal injection.
Methods


Patients undergoing routine intravitreal injection were recruited for a randomized controlled trial. Subjects complete a State-Trait Anxiety Inventory (STAI-S) questionnaire before and after undergoing injection with or without background music. They were also assessed for subjective satisfaction, anxiety, pain, and future preferences after the injection.
Results


There were 39 and 37 Chinese subjects in the music (age 68.08 ± 13.67) and control (age 73.24 ± 11.17) groups, respectively. The music group reported lower anxiety and pain, and a greater reduction in STAI-S score, but the differences were not statistically significant ( P  = 0.830, 0.655, 0.199, respectively). More subjects in the music group (92.3%, control group 64.9%) preferred music for future injections ( P  = 0.003). Age, but not the number of previous injections, was negatively correlated with reported anxiety ( r  = -0.27,  P  = 0.021).
Conclusion


Most subjects preferred music during future injections. Although music reduced anxiety, the effect was not statistically significant and may be masked by the higher age of our control group, as increasing age was correlated with lower anxiety.",2020,"More subjects in the music group (92.3%, control group 64.9%) preferred music for future injections ( P  = 0.003).","['37 Chinese subjects in the music (age 68.08\u2009±\u200913.67) and control (age 73.24\u2009±\u200911.17) groups, respectively', 'Methods\n\n\nPatients undergoing routine intravitreal injection']","['Intravitreal Injection', 'Music']","['subjective satisfaction, anxiety, pain, and future preferences', 'State-Trait Anxiety Inventory (STAI-S) questionnaire', 'STAI-S score', 'lower anxiety and pain']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}]","[{'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.049334,"More subjects in the music group (92.3%, control group 64.9%) preferred music for future injections ( P  = 0.003).","[{'ForeName': 'Jonathan Cheuk-Hung', 'Initials': 'JC', 'LastName': 'Chan', 'Affiliation': 'Department of Ophthalmology, LKS Faculty of Medicine, University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Lok Pong', 'Initials': 'LP', 'LastName': 'Chan', 'Affiliation': 'LKS Faculty of Medicine, University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Chi Pong', 'Initials': 'CP', 'LastName': 'Yeung', 'Affiliation': 'LKS Faculty of Medicine, University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Tin Wai', 'Initials': 'TW', 'LastName': 'Tang', 'Affiliation': 'LKS Faculty of Medicine, University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Yip Mang', 'Initials': 'YM', 'LastName': 'O', 'Affiliation': 'LKS Faculty of Medicine, University of Hong Kong, Pok Fu Lam, Hong Kong.'}, {'ForeName': 'Wai Ching', 'Initials': 'WC', 'LastName': 'Lam', 'Affiliation': 'Department of Ophthalmology, LKS Faculty of Medicine, University of Hong Kong, Pok Fu Lam, Hong Kong.'}]",Journal of ophthalmology,['10.1155/2020/9120235']
2356,32802661,Intraoperative Autoderm Decontamination for Use in Immediate Single-stage Direct-to-implant Breast Reconstruction.,"Acellular dermal matrix (ADM) in direct-to-implant breast cancer reconstruction is the standard of care due to superior cosmetic results and decreased capsular contracture, but can be cost prohibitive. Although more economical, using patient's own dermis (""Autoderm"") instead of ADM has undescribed sterility. Sterility is essential, as bacterial contamination may cause infection and capsular contraction. This study aimed to determine the sterility and optimal decontamination protocol of Autoderm.
Methods


A prospective controlled study of 140 samples from 20 DIEP (deep inferior epigastric perforator) breast cancer reconstruction patients was performed. Seven de-epithelialized dermal samples (2 × 1 cm) per patient were collected from excess abdominal tissue (6 decontamination protocols and one control). Samples were submerged in povidone-iodine, chlorhexidine, or cefazolin/tobramycin/bacitracin for 15 minutes; half of the samples were agitated (150 rpm) for 15 minutes, and half were not. The control was normal saline without agitation. The solution was removed, and the tissue was sent for aerobic colony count cultures. Patient's demographic data and complications were also collected.
Results


Of 140 samples, 3 of 20 non-agitated povidone-iodine and 1 of 20 control samples had aerobic bacterial growth. All of the other 100 samples from 5 experimental groups (povidone-iodine + agitation, chlorhexidine ± agitation, and cefazolin/tobramycin/bacitracin ± agitation) had no aerobic bacterial growth.
Conclusions


This study suggests povidone-iodine + agitation, chlorhexidine ± agitation, and cefazolin/tobramycin/bacitracin ± agitation are effective at sterilizing de-epithelialized dermis, whereas povidone-iodine without agitation and saline are ineffective. Autoderm with the appropriate decontamination protocol may be a potential sterile alternative to ADM.",2020,"Results


Of 140 samples, 3 of 20 non-agitated povidone-iodine and 1 of 20 control samples had aerobic bacterial growth.",['140 samples from 20 DIEP (deep inferior epigastric perforator) breast cancer reconstruction patients'],"['Acellular dermal matrix (ADM', 'Intraoperative Autoderm Decontamination', 'povidone-iodine + agitation, chlorhexidine ± agitation, and cefazolin/tobramycin/bacitracin ± agitation', 'povidone-iodine, chlorhexidine, or cefazolin/tobramycin/bacitracin']",['aerobic bacterial growth'],"[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0082274', 'cui_str': 'Diclofenac epolamine'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0182209', 'cui_str': 'Perforator'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3494272', 'cui_str': 'Acellular Dermal Matrix'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0011121', 'cui_str': 'Decontamination'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0007546', 'cui_str': 'Cefazolin'}, {'cui': 'C0040341', 'cui_str': 'Tobramycin'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}]","[{'cui': 'C0427944', 'cui_str': 'Determination of bacterial growth'}]",,0.0280202,"Results


Of 140 samples, 3 of 20 non-agitated povidone-iodine and 1 of 20 control samples had aerobic bacterial growth.","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Diaz-Abele', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Padalko', 'Affiliation': 'Max Rady College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Dalke', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Brichacek', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Buchel', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, University of Manitoba, Winnipeg, Manitoba, Canada.'}]",Plastic and reconstructive surgery. Global open,['10.1097/GOX.0000000000002968']
2357,32802709,Efficacy and safety of a combination of an insulin secretagogue and a dipeptidyl peptidase-4 inhibitor in Japanese patients with type 2 diabetes mellitus; the repaglinide glucose oscillation study in Fukuoka (REGO-F).,"Abstract


Dipeptidyl peptidase-4 inhibitors (DPP-4Is) are one of the most frequently prescribed anti-diabetic agents in Japan, and they are often used in combination with insulin secretagogues, such as sulfonylureas and glinides. In the present study, we determined the efficacy and safety of the use of repaglinide or glimepiride, a sulfonylurea, in combination with a DPP-4I, in Japanese patients with type 2 diabetes mellitus (T2DM). This study was an investigator-initiated, open-label, randomized, multi-center prospective study. Patients with T2DM, which was inadequately controlled using a DPP-4I, were randomized to a repaglinide group or a glimepiride group and treated for 48 weeks. The primary outcomes were the reductions in glycated hemoglobin (HbA1c) and glucose oscillation, identified using continuous glucose monitoring, after 12 weeks. The secondary outcome was the change in carotid intima-media thickness (IMT), measured by ultrasonography, after 48 weeks. A total of 61 patients were recruited and analyzed in the study. Twelve weeks of treatment with 1.5 mg repaglinide or 1 mg glimepiride significantly reduced HbA1c, and a larger reduction in HbA1c occurred in the repaglinide group than the glimepiride group. Mean subcutaneous glucose concentration was significantly reduced in both groups, but the glucose oscillation did not decrease. Interestingly, the mean left IMT significantly increased in the glimepiride group, but not in the repaglinide group. More hypoglycemic events were observed in the glimepiride group. These data suggest that repaglinide reduces HbA1c more effectively than glimepiride when used in combination with a DPP-4I, and causes fewer hypoglycemic events.
Trail registry


This study is registered with UMIN-CTR (UMIN000018321).",2020,"Interestingly, the mean left IMT significantly increased in the glimepiride group, but not in the repaglinide group.","['Japanese patients with type 2 diabetes mellitus (T2DM', 'Japanese patients with type 2 diabetes mellitus', 'Patients with T2DM, which was inadequately controlled using a DPP-4I', 'A total of 61 patients were recruited and analyzed in the study']","['repaglinide', 'glimepiride', 'repaglinide or glimepiride, a sulfonylurea', 'Abstract\n\n\nDipeptidyl peptidase-4 inhibitors (DPP-4Is', 'insulin secretagogue and a dipeptidyl peptidase-4 inhibitor']","['mean left IMT', 'Mean subcutaneous glucose concentration', 'Efficacy and safety', 'change in carotid intima-media thickness (IMT', 'efficacy and safety', 'larger reduction in HbA1c', 'glycated hemoglobin (HbA1c) and glucose oscillation, identified using continuous glucose monitoring', 'hypoglycemic events']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl peptidase IV inhibitor'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C4704833', 'cui_str': 'Secretagogue'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0427743', 'cui_str': 'Glucose concentration, test strip measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",61.0,0.0238987,"Interestingly, the mean left IMT significantly increased in the glimepiride group, but not in the repaglinide group.","[{'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Terawaki', 'Affiliation': 'Futata Tetsuhiro Clinic, 1-2-17 Meinohamaekiminami, Nishi-ku, Fukuoka, 819-0006 Japan.'}, {'ForeName': 'Chikayo', 'Initials': 'C', 'LastName': 'Iwaya', 'Affiliation': 'Muta Hospital, 3-9-1 Hoshikuma, Sawara-ku, Fukuoka, 814-0163 Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nomiyama', 'Affiliation': 'Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180 Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Shimono', 'Affiliation': 'Futata Tetsuhiro Clinic, 1-2-17 Meinohamaekiminami, Nishi-ku, Fukuoka, 819-0006 Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Horikawa', 'Affiliation': 'Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180 Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Fujimura-Tanaka', 'Affiliation': 'Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180 Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Shigeoka', 'Affiliation': 'Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180 Japan.'}, {'ForeName': 'Nobuya', 'Initials': 'N', 'LastName': 'Hamanoue', 'Affiliation': 'Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180 Japan.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Motonaga', 'Affiliation': 'Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180 Japan.'}, {'ForeName': 'Makito', 'Initials': 'M', 'LastName': 'Tanabe', 'Affiliation': 'Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180 Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Yanase', 'Affiliation': 'Muta Hospital, 3-9-1 Hoshikuma, Sawara-ku, Fukuoka, 814-0163 Japan.'}, {'ForeName': 'Daiji', 'Initials': 'D', 'LastName': 'Kawanami', 'Affiliation': 'Department of Endocrinology and Diabetes Mellitus, School of Medicine, Fukuoka University, 7-45-1 Nanakuma, Jonan-ku, Fukuoka, 814-0180 Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetology international,['10.1007/s13340-020-00426-w']
2358,32802764,Efficacy testing of the SAVOR (Sisters Adding Fruits and Vegetables for Optimal Results) intervention among African American women: A randomized controlled trial.,"Background:  In the United States, only about 15% of individuals meet daily fruit intake recommendations of 2 cups per day and only 10% meet the vegetable intake recommendations of3 cups per day. African American women are a high-risk group. In this study, a fourth-generation multi-theory model (MTM) of health behavior change was used to design and evaluate a SistersAdding Fruits and Vegetables for Optimal Results (SAVOR) intervention for AA women.  Methods:  The study utilized a randomized controlled trial (RCT) with measurements taken at pretest, posttest (after the three-week intervention) and follow-up (at the end of eight weeks).SAVOR (n=26) was compared to an equivalent knowledge-based intervention (n=28). Process evaluation was done for program fidelity and satisfaction. A validated 38-item self-reported questionnaire was used to measure changes in MTM constructs and past 24-hour consumption of fruits and vegetables.  Results:  The SAVOR intervention resulted in improvement of mean consumption of fruits and vegetables in the experimental group from pre-test (2.78) to posttest (4.77) to recommended levels at follow-up (5.04) while in the comparison group they remained at around 3 (P<0.0001)Statistically significant changes (P<0.05) were noted for all MTM constructs except for participatory dialogue.  Conclusion:  The SAVOR intervention was found to be efficacious and established the robustness of MTM. SAVOR can be replicated for future effectiveness trials.",2020,The SAVOR intervention resulted in improvement of mean consumption of fruits and vegetables in the experimental group from pre-test (2.78) to posttest (4.77) to recommended levels at follow-up (5.04) while in the comparison group they remained at around 3 (P<0.0001)Statistically significant changes (P<0.05) were noted for all MTM constructs except for participatory dialogue.  ,"['AA women', 'African American women']","['SAVOR (Sisters Adding Fruits and Vegetables for Optimal Results) intervention', 'SistersAdding Fruits and Vegetables for Optimal Results (SAVOR) intervention', 'SAVOR intervention']",['mean consumption of fruits and vegetables'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}]","[{'cui': 'C0337514', 'cui_str': 'Sister'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}]",,0.0386849,The SAVOR intervention resulted in improvement of mean consumption of fruits and vegetables in the experimental group from pre-test (2.78) to posttest (4.77) to recommended levels at follow-up (5.04) while in the comparison group they remained at around 3 (P<0.0001)Statistically significant changes (P<0.05) were noted for all MTM constructs except for participatory dialogue.  ,"[{'ForeName': 'LaVonne', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Behavioral & Environmental Health, School of Public Health, Jackson State University, MS, USA.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Sharma', 'Affiliation': 'Behavioral & Environmental Health, School of Public Health, Jackson State University, MS, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Leggett', 'Affiliation': 'Behavioral & Environmental Health, School of Public Health, Jackson State University, MS, USA.'}, {'ForeName': 'Jung Hye', 'Initials': 'JH', 'LastName': 'Sung', 'Affiliation': 'Behavioral & Environmental Health, School of Public Health, Jackson State University, MS, USA.'}, {'ForeName': 'Russell L', 'Initials': 'RL', 'LastName': 'Bennett', 'Affiliation': 'Behavioral & Environmental Health, School of Public Health, Jackson State University, MS, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Azevedo', 'Affiliation': 'Behavioral & Environmental Health, School of Public Health, Jackson State University, MS, USA.'}]",Health promotion perspectives,['10.34172/hpp.2020.41']
2359,32802771,The Influence of the Suture-less Anterior Releasing Incision in a Triangular Flap Design on Postoperative Healing Following Surgical Removal of Impacted Mandibular Third Molars.,"Objectives


The objective of this study was to determine the effect of suture-less anterior releasing incisions on postoperative wound healing following surgical removal of impacted mandibular third molars.
Materials and Methods


A total of 112 patients were included in the study. Group 1 had 56 patients in which the anterior releasing incision was not sutured postoperatively, and group 2 had 56 patients, in whom the anterior releasing incision was sutured. The two groups were compared in terms of pain, swelling, and trismus at 1 day, 3 days, and 7 days postoperatively. The Univariate Type III Repeated-Measures ANOVA Assuming Sphericity was used to compare the two modes of treatments at different time points. The periodontal healing distal to the second molar was assessed on the first day and at 2 months following the surgical intervention. The independent  t  test was used to compare the periodontal healing between the two groups at two time points.
Results


No significant difference was observed between the two groups for pain and trismus ( P  > 0.05). However, the swelling was significantly greater in group 2 as compared to group 1 ( P  < 0.001). Periodontal healing was better in group 2, which showed lower periodontal probing depth distal to the mandibular second molar, compared to group 1 ( P  < 0.05).
Conclusion


Suture-less anterior releasing incision decreases the postoperative swelling and edema, but the periodontal healing was poor when compared to the sutured anterior releasing incision cases. The type of closure technique did not have any significant influence on pain and trismus.",2020,"However, the swelling was significantly greater in group 2 as compared to group 1 ( P  < 0.001).","['Postoperative Healing Following Surgical Removal of Impacted Mandibular Third Molars', 'surgical removal of impacted mandibular third molars', 'A total of 112 patients were included in the study']","['suture-less anterior releasing incisions', 'Conclusion\n\n\nSuture-less anterior releasing incision', 'anterior releasing incision', 'Suture-less Anterior Releasing Incision']","['postoperative swelling and edema', 'swelling', 'periodontal probing depth distal', 'Periodontal healing', 'pain, swelling, and trismus', 'periodontal healing', 'pain and trismus', 'postoperative wound healing']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0184898', 'cui_str': 'Incision'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C1882337', 'cui_str': 'Periodontal probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}]",112.0,0.0219539,"However, the swelling was significantly greater in group 2 as compared to group 1 ( P  < 0.001).","[{'ForeName': 'Sunil S', 'Initials': 'SS', 'LastName': 'Nayak', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Arora', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Ashmeet', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Amee', 'Initials': 'A', 'LastName': 'Sanghavi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Abhay T', 'Initials': 'AT', 'LastName': 'Kamath', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}, {'ForeName': 'Vanishri S', 'Initials': 'VS', 'LastName': 'Nayak', 'Affiliation': 'Department of Anatomy, Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal, Karnataka, India.'}]",Journal of International Society of Preventive & Community Dentistry,['10.4103/jispcd.JISPCD_444_19']
2360,32802784,Qualitative and Quantitative Assessment of Remineralizing Effect of Prophylactic Toothpaste Promoting Brushite Formation: A Randomized Clinical Trial.,"Background


Currently various studies are conducted to improve the effect of existing and developing new remineralizing agents. One of the trends in remineralizing therapy is the development of toothpaste allowing brushite crystals formation in the demineralized lesions of hard tooth tissues.
Aim


The aim of this study was to assess the effect of toothpaste, forming a brushite, on the functional acid resistance of enamel and the speed of its remineralization.
Materials and Methods


This was a randomized controlled double-blind clinical study. Sixty consent patients aged 20-25 years were enrolled in the three groups: test group ( n  = 20), positive control group ( n  = 20), and negative control group ( n  = 20), which used brushite-forming toothpaste, toothpaste with hydroxyapatite (HAP), and toothpaste without remineralizing agents, respectively. The hygiene indices, the rate of enamel remineralization, the dynamics of acid resistance of enamel, and the level of enamel sensitivity were determined at baseline, after 2 and 4 weeks to assess the effectiveness of toothpastes. Friedman rank sum test (for related variables) and the Kruskal-Wallis rank sum test (for independent variables) with Nemenyi  post hoc  test were used for statistical comparisons.
Results


The study test and positive control groups showed significantly greater acid resistance of enamel ( P  > 0.05) and rate of its remineralization at the study endpoints as compared with negative control group.In the test and positive control groups, Schiff index values significantly decreased after 4 weeks, whereas in the negative control group no significant differences were observed at the study time points. The oral hygiene level improved significantly after 2 and 4 weeks in all groups.
Conclusion


The 30-day use of paste that promotes brushite formation and paste with hydroxyapatite resulted in faster enamel remineralization and higher enamel resistance. Brushite-containing toothpaste may be used as an alternative to HAP containing for remineralizing and desensitizing treatment.",2020,The study test and positive control groups showed significantly greater acid resistance of enamel ( P  > 0.05) and rate of its remineralization at the study endpoints as compared with negative control group.,['Sixty consent patients aged 20-25 years'],"['Prophylactic Toothpaste Promoting Brushite Formation', 'hydroxyapatite', 'positive control group ( n  = 20), and negative control group ( n  = 20), which used brushite-forming toothpaste, toothpaste with hydroxyapatite (HAP), and toothpaste without remineralizing agents, respectively', 'toothpaste']","['acid resistance of enamel', 'oral hygiene level', 'rate of its remineralization', 'Schiff index values', 'faster enamel remineralization and higher enamel resistance', 'rate of enamel remineralization, the dynamics of acid resistance of enamel, and the level of enamel sensitivity']","[{'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0054169', 'cui_str': 'brushite'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0020326', 'cui_str': 'Hydroxyapatite Derivatives'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2949227', 'cui_str': 'Schiff'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",60.0,0.0966919,The study test and positive control groups showed significantly greater acid resistance of enamel ( P  > 0.05) and rate of its remineralization at the study endpoints as compared with negative control group.,"[{'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Polyakova', 'Affiliation': 'Department of Therapeutic Dentistry, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Marianna G', 'Initials': 'MG', 'LastName': 'Arakelyan', 'Affiliation': 'Department of Therapeutic Dentistry, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Ksenia S', 'Initials': 'KS', 'LastName': 'Babina', 'Affiliation': 'Department of Therapeutic Dentistry, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Edita G', 'Initials': 'EG', 'LastName': 'Margaryan', 'Affiliation': 'Department of Therapeutic Dentistry, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Inna A', 'Initials': 'IA', 'LastName': 'Sokhova', 'Affiliation': 'Department of Therapeutic Dentistry, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Vladlena Yu', 'Initials': 'VY', 'LastName': 'Doroshina', 'Affiliation': 'Department of Therapeutic Dentistry, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.'}, {'ForeName': 'Nina E', 'Initials': 'NE', 'LastName': 'Novozhilova', 'Affiliation': 'Department of Therapeutic Dentistry, I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.'}]",Journal of International Society of Preventive & Community Dentistry,['10.4103/jispcd.JISPCD_493_19']
2361,32803005,"Effect of integrated health promotion intervention and follow up on health issues (clothing way, food habits, urinary habits, sexual behavior habits) related to urinary tract infection among pregnant women. A randomized, clinical trial.","Introduction


Urinary tract infection, as an important health element is associated with the risk of many problems in pregnancy and support consulting is effective factor in reducing the problem. Aim of this study is to evaluate the impacts of integrated intervention on life style (clothing way, food habits, urinary habits, sexual behavior habits) Related to Urinary Tract Infection Among Pregnant women.
Method


This interventional used pretest- posttest design with the control group study was performed on 130 healthy pregnant women. The samples were divided randomly into two groups of 65 people. The first group received two sessions of 45 to 60 minutes Psychoeducational counseling, four telephone follow-up support and training pamphlets and the control group received routine education. The relevant questionnaires were completed by both groups before the intervention and a month later. The data were analyzed with Spss V.22 software.
Results


Comparing within the groups it was shown that the variables were increased in the experimental group after consulting compared to the conditions before consulting (P < 0.001), however, no increasing was found in the average variables before consulting and after it. Moreover, comparing the variables in two experimental and control groups significant statistical difference was found in different studied areas after consulting (P < 0.0001).
Conclusions


Psychological counseling and phone follow-up are effective in improving the knowledge, attitude, and performance of pregnant women in preventing the urinary infection Therefor it is recommended these trends to be considered as training programs in order to increase capacity and primary prevention of pregnant women.",2020,"Conclusions


Psychological counseling and phone follow-up are effective in improving the knowledge, attitude, and performance of pregnant women in preventing the urinary infection Therefor it is recommended these trends to be considered as training programs in order to increase capacity and primary prevention of pregnant women.","['Pregnant women', '130 healthy pregnant women', 'pregnant women']","['integrated health promotion intervention', 'Psychoeducational counseling, four telephone follow-up support and training pamphlets and the control group received routine education', 'integrated intervention']","['life style (clothing way, food habits, urinary habits, sexual behavior habits', 'Urinary Tract Infection', 'health issues (clothing way, food habits, urinary habits, sexual behavior habits']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0009072', 'cui_str': 'Garments'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}]",130.0,0.0118701,"Conclusions


Psychological counseling and phone follow-up are effective in improving the knowledge, attitude, and performance of pregnant women in preventing the urinary infection Therefor it is recommended these trends to be considered as training programs in order to increase capacity and primary prevention of pregnant women.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yazdi', 'Affiliation': 'Midwifery Department, School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Alidousti', 'Affiliation': 'Midwifery Department, School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Tirgari', 'Affiliation': 'Nursing Research Center, Medical Surgical Department, School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Jahani', 'Affiliation': 'Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran.'}]",Journal of preventive medicine and hygiene,['10.15167/2421-4248/jpmh2020.61.2.1412']
2362,32803023,Feasibility study of stem-cell enriched autologous lipotransfer to treat oro-facial fibrosis in systemic sclerosis (Sys-Stem): Protocol for open-label randomised controlled trial.,"Introduction


Oro-facial fibrosis is a common and disabling manifestation of systemic sclerosis (SSc), causing a plethora of functional, aesthetic and social compromise, yet is without effective treatment. Autologous lipotransfer is an established minimally invasive surgical procedure that is postulated to exert anti-fibrotic effects by adipose-derived stem cells, and presents a novel method in the treatment of fibrotic conditions. This study aims to assess the safety and efficacy of autologous lipotransfer for facial involvement in SSc.
Methods and analysis


This is the first randomised controlled study with an open label design to assess autologous lipotransfer for oro-facial involvement in systemic sclerosis. The goals of this study are to assess the feasibility of using a range of quantitative and qualitative outcome measures to effectively measure disease severity and treatment outcome, and to assess patient acceptability for future multi-centre trials. A total of 50 participants will be randomised to a treatment or control group. The treatment group will receive autologous fat transfer to the peri-oral region by a single surgeon. Dermal fibroblasts and adipose-derived stem cells will be isolated from tissue samples. All outcome measures will be taken at baseline, then at 6 weeks, 3 months and 6 months from the time of intervention in the treatment arm, or from baseline in the control arm.
Ethics and dissemination


The study has ethical approval (REC reference 19/LO/0718). Results will be available to patients, patient user groups, clinicians and the public through presentations at national and international rheumatology conferences and published in peer reviewed journals.
Trial registration


Registered on ISRCTN registry (ISRCTN17793055).",2020,"Results will be available to patients, patient user groups, clinicians and the public through presentations at national and international rheumatology conferences and published in peer reviewed journals.
","['systemic sclerosis (Sys-Stem', '50 participants']","['Autologous lipotransfer', 'autologous lipotransfer', 'stem-cell enriched autologous lipotransfer', 'autologous fat transfer to the peri-oral region by a single surgeon']",['safety and efficacy'],"[{'cui': 'C0036421', 'cui_str': 'Systemic sclerosis'}, {'cui': 'C0162731', 'cui_str': 'STEM'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C4076692', 'cui_str': 'Autologous fat'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",50.0,0.142805,"Results will be available to patients, patient user groups, clinicians and the public through presentations at national and international rheumatology conferences and published in peer reviewed journals.
","[{'ForeName': 'Faith Hyun Kyung', 'Initials': 'FHK', 'LastName': 'Jeon', 'Affiliation': 'Division of Surgery and Interventional Sciences, University College London, London, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Griffin', 'Affiliation': 'Division of Surgery and Interventional Sciences, University College London, London, UK.'}, {'ForeName': 'Christopher Paul', 'Initials': 'CP', 'LastName': 'Denton', 'Affiliation': 'Centre for Rheumatology and Connective Tissue Diseases, Division of Medicine, Royal Free Campus, University College London, London, UK.'}, {'ForeName': 'Peter Edward Michael', 'Initials': 'PEM', 'LastName': 'Butler', 'Affiliation': 'Division of Surgery and Interventional Sciences, University College London, London, UK.'}]",International journal of surgery protocols,['10.1016/j.isjp.2020.07.002']
2363,32803106,"Short-Term Glucocorticoid Treatment Reduces Circulating Sclerostin Concentrations in Healthy Young Men: A Randomized, Placebo-Controlled, Double-Blind Study.","Glucocorticoid use is the most common cause of osteoporosis in young individuals. In the current study, we investigated the effects of glucocorticoid treatment on circulating sclerostin concentrations and serum bone turnover markers in healthy young men. We performed additional measurements in two combined randomized, placebo-controlled, double-blind, dose-response intervention studies: 64 healthy men (age: 22 ± 2 years; BMI: 22.1 ± 1.7 kg/m 2 ) were allocated to receive placebo ( n  = 16), prednisolone 7.5 mg once daily ( n  = 24), or prednisolone 30 mg once daily ( n  = 24) for 2 weeks using block randomization. Primary outcome variables were serum sclerostin and serum bone turnover markers (CTx and P1NP), before and after the intervention. Baseline characteristics and variables did not differ between intervention groups. Compared with placebo, prednisolone high-dose decreased serum sclerostin concentrations (-8.5 [-28.0 to 7.3] versus 1.5 [-6.5 to 20.0] pg/mL,  p  = 0.048), decreased P1NP concentrations (-28.0 [-39.3 to -18.3] versus -1.5 [-15.3 to 11.3] μg/L,  p  < 0.001) and increased CTx concentrations (108.0 [55.0 to 177.0] versus 64.0 [-24.3 to 120.0] ng/L,  p  = 0.038). Compared with placebo, prednisolone low-dose did not alter sclerostin concentrations ( p  = 0.5) or CTx concentrations ( p =  0.7), but tended to decrease P1NP concentrations (-9.0 [-24.0 to -1.3] versus -1.5 [-15.3 to 11.3] μg/L,  p  = 0.095). At baseline concentrations of sclerostin were positively correlated with concentrations of CTx (Spearman's rank correlation coefficient ρ = +0.409,  p  = 0.001), but not with P1NP. No significant correlations were observed between changes in outcome variables during the interventions. Short-term high-dose, but not low-dose, prednisolone treatment reduces serum sclerostin concentrations in healthy young men. Whether this reflects a counter regulatory mechanism to compensate glucocorticoid-induced negative effects through other mechanisms remains to be elucidated. © 2020 The Authors.  JBMR Plus  published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research.",2020,"Compared with placebo, prednisolone low-dose did not alter sclerostin concentrations ( p  = 0.5) or CTx concentrations ( p =  0.7), but tended to decrease P1NP concentrations (-9.0 [-24.0 to -1.3] versus -1.5 [-15.3 to 11.3] μg/L,  p  = 0.095).","['2020', 'Healthy Young Men', 'young individuals', 'healthy young men', '64 healthy men (age: 22\u2009±\u20092\u2009years; BMI: 22.1\u2009±\u20091.7\u2009kg/m 2 ']","['placebo, prednisolone', 'Placebo', 'Short-Term Glucocorticoid Treatment', 'Glucocorticoid', 'prednisolone 7.5\u2009mg once daily ( n  = 24), or prednisolone', 'glucocorticoid', 'prednisolone', 'placebo']","['P1NP concentrations', 'serum sclerostin concentrations', 'Circulating Sclerostin Concentrations', 'serum sclerostin and serum bone turnover markers (CTx and P1NP', 'sclerostin concentrations', 'CTx concentrations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517512', 'cui_str': '1.7'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}]","[{'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}]",64.0,0.424515,"Compared with placebo, prednisolone low-dose did not alter sclerostin concentrations ( p  = 0.5) or CTx concentrations ( p =  0.7), but tended to decrease P1NP concentrations (-9.0 [-24.0 to -1.3] versus -1.5 [-15.3 to 11.3] μg/L,  p  = 0.095).","[{'ForeName': 'Merel', 'Initials': 'M', 'LastName': 'Jacobsson', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Amsterdam UMC Amsterdam The Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Amsterdam UMC Amsterdam The Netherlands.'}, {'ForeName': 'Annemieke C', 'Initials': 'AC', 'LastName': 'Heijboer', 'Affiliation': 'Endocrine Laboratory, Department of Clinical Chemistry, Amsterdam UMC University of Amsterdam Amsterdam The Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'den Heijer', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Amsterdam UMC Amsterdam The Netherlands.'}, {'ForeName': 'Renate T', 'Initials': 'RT', 'LastName': 'de Jongh', 'Affiliation': 'Department of Internal Medicine, Division of Endocrinology, Amsterdam UMC Amsterdam The Netherlands.'}]",JBMR plus,['10.1002/jbm4.10341']
2364,32803100,Reduced Bacterial Burden of the Skin Surrounding the Shoulder Joint Following Topical Protocatechuic Acid Application: Results of a Pilot Study.,"Background


Reducing the rising health-care burden associated with shoulder surgical site infection (SSI) is of paramount importance. The purpose of this study was to investigate the antimicrobial efficacy of protocatechuic acid (PCA) as a topical reagent for surgical skin antisepsis surrounding the shoulder joint.
Methods


This was a 2-phase skin-disinfection trial involving the human shoulder. The shoulders of healthy volunteers were randomized to topical treatment with PCA (a 10% concentration of PCA in Phase I [11 subjects] and a 17% concentration in Phase II [12 subjects]), with a control of isopropyl alcohol (IPA) applied to the contralateral shoulder. Mechanical scraping was performed for skin harvest following reagent application, and samples were sent for aerobic and anaerobic culture. Sterilization rates and bacterial counts were determined for each treatment group, and the proportion of subjects with persistent  Cutibacterium acnes  colonization following topical application of PCA was determined using DNA sequencing analysis.
Results


The topical application of 10% PCA was associated with significantly higher aerobic and anaerobic sterilization rates (90.9% and 81.8%, respectively) compared with treatment with IPA (p = 0.0143 and p = 0.0253, respectively). The topical application of 17% PCA was associated with a significantly higher anaerobic sterilization rate (83.3%) and trended toward a significantly higher aerobic sterilization rate (91.7%) compared with treatment with IPA (p = 0.0143 and p = 0.083, respectively).  C. acnes  was identified in 18.2% and 0% of subjects following treatment with 10% and 17% PCA, respectively.
Conclusions


The topical application of PCA was associated with a reduction in the bacterial burden of human shoulder skin and demonstrated dose-dependent antimicrobial activity against  C. acnes  in young, healthy subjects. Clinical studies in a shoulder surgical population are warranted to determine the potential for application in surgical skin antisepsis to reduce shoulder SSI.
Level of Evidence


Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2020,"The topical application of 17% PCA was associated with a significantly higher anaerobic sterilization rate (83.3%) and trended toward a significantly higher aerobic sterilization rate (91.7%) compared with treatment with IPA (p = 0.0143 and p = 0.083, respectively).  ","['young, healthy subjects', 'shoulders of healthy volunteers']","['PCA', 'isopropyl alcohol (IPA', 'protocatechuic acid (PCA']","['aerobic and anaerobic sterilization rates', 'Sterilization rates and bacterial counts', 'anaerobic sterilization rate', 'aerobic sterilization rate']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]","[{'cui': 'C0072489', 'cui_str': 'protocatechuic acid'}, {'cui': 'C0022237', 'cui_str': 'Isopropyl Alcohol'}]","[{'cui': 'C0038280', 'cui_str': 'Sterilization'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}]",,0.0454613,"The topical application of 17% PCA was associated with a significantly higher anaerobic sterilization rate (83.3%) and trended toward a significantly higher aerobic sterilization rate (91.7%) compared with treatment with IPA (p = 0.0143 and p = 0.083, respectively).  ","[{'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Jalali', 'Affiliation': 'Keck School of Medicine of USC, Los Angeles, California.'}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Best', 'Affiliation': 'Loma Linda Department of Orthopedics (M.B.) and Loma Linda University School of Medicine (A.W., B.S., and B.B.), Loma Linda, California.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Loma Linda Department of Orthopedics (M.B.) and Loma Linda University School of Medicine (A.W., B.S., and B.B.), Loma Linda, California.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Schaeffer', 'Affiliation': 'Loma Linda Department of Orthopedics (M.B.) and Loma Linda University School of Medicine (A.W., B.S., and B.B.), Loma Linda, California.'}, {'ForeName': 'Brendon', 'Initials': 'B', 'LastName': 'Bauer', 'Affiliation': 'Loma Linda Department of Orthopedics (M.B.) and Loma Linda University School of Medicine (A.W., B.S., and B.B.), Loma Linda, California.'}, {'ForeName': 'Lanny', 'Initials': 'L', 'LastName': 'Johnson', 'Affiliation': 'Keck School of Medicine of USC, Los Angeles, California.'}]",JB & JS open access,['10.2106/JBJS.OA.19.00078']
2365,32803109,Gene Expression Profile and Acute Gene Expression Response to Sclerostin Inhibition in Osteogenesis Imperfecta Bone.,"Sclerostin antibody (SclAb) therapy has been suggested as a novel therapeutic approach toward addressing the fragility phenotypic of osteogenesis imperfecta (OI). Observations of cellular and transcriptional responses to SclAb in OI have been limited to mouse models of the disorder, leaving a paucity of data on the human OI osteoblastic cellular response to the treatment. Here, we explore factors associated with response to SclAb therapy in vitro and in a novel xenograft model using OI bone tissue derived from pediatric patients. Bone isolates (approximately 2 mm 3 ) from OI patients (OI type III, type III/IV, and type IV,  n  = 7; non-OI control,  n  = 5) were collected to media, randomly assigned to an untreated (UN), low-dose SclAb (TRL, 2.5 μg/mL), or high-dose SclAb (TRH, 25 μg/mL) group, and maintained in vitro at 37°C. Treatment occurred on days 2 and 4 and was removed on day 5 for TaqMan qPCR analysis of genes related to the  Wnt  pathway. A subset of bone was implanted s.c. into an athymic mouse, representing our xenograft model, and treated (25 mg/kg s.c. 2×/week for 2/4 weeks). Implanted OI bone was evaluated using μCT and histomorphometry. Expression of  Wnt/Wnt -related targets varied among untreated OI bone isolates. When treated with SclAb, OI bone showed an upregulation in osteoblast and osteoblast progenitor markers, which was heterogeneous across tissue. Interestingly, the greatest magnitude of response generally corresponded to samples with low untreated expression of progenitor markers. Conversely, samples with high untreated expression of these markers showed a lower response to treatment. in vivo implanted OI bone showed a bone-forming response to SclAb via μCT, which was corroborated by histomorphometry. SclAb induced downstream  Wnt  targets  WISP1  and  TWIST1 , and elicited a compensatory response in  Wnt  inhibitors  SOST  and  DKK1  in OI bone with the greatest magnitude from OI cortical bone. Understanding patients' genetic, cellular, and morphological bone phenotypes may play an important role in predicting treatment response. This information may aid in clinical decision-making for pharmacological interventions designed to address fragility in OI. © 2020 The Authors.  JBMR Plus  published by Wiley Periodicals, Inc. on behalf of American Society for Bone and Mineral Research.",2020,"SclAb induced downstream  Wnt  targets  WISP1  and  TWIST1 , and elicited a compensatory response in  Wnt  inhibitors  SOST  and  DKK1  in OI bone with the greatest magnitude from OI cortical bone.","['2020', 'pediatric patients']",['Sclerostin antibody (SclAb) therapy'],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",[],,0.035271,"SclAb induced downstream  Wnt  targets  WISP1  and  TWIST1 , and elicited a compensatory response in  Wnt  inhibitors  SOST  and  DKK1  in OI bone with the greatest magnitude from OI cortical bone.","[{'ForeName': 'Rachel K', 'Initials': 'RK', 'LastName': 'Surowiec', 'Affiliation': 'Department of Biomedical Engineering University of Michigan Ann Arbor MI USA.'}, {'ForeName': 'Lauren F', 'Initials': 'LF', 'LastName': 'Battle', 'Affiliation': 'Department of Orthopaedic Surgery University of Michigan Ann Arbor MI USA.'}, {'ForeName': 'Stephen H', 'Initials': 'SH', 'LastName': 'Schlecht', 'Affiliation': 'Department of Orthopaedic Surgery University of Michigan Ann Arbor MI USA.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Wojtys', 'Affiliation': 'Department of Orthopaedic Surgery University of Michigan Ann Arbor MI USA.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Caird', 'Affiliation': 'Department of Orthopaedic Surgery University of Michigan Ann Arbor MI USA.'}, {'ForeName': 'Kenneth M', 'Initials': 'KM', 'LastName': 'Kozloff', 'Affiliation': 'Department of Biomedical Engineering University of Michigan Ann Arbor MI USA.'}]",JBMR plus,['10.1002/jbm4.10377']
2366,32808736,Reverse remodeling after percutaneous transluminal septal myocardial ablation in severe but asymptomatic LVOT obstruction (RASTA) study: Rationale and design of transcatheter septal reduction in asymptomatic patients with severe hypertrophic obstructive cardiomyopathy.,"OBJECTIVES


The aim of this study is to evaluate the impact of percutaneous transluminal septal myocardial ablation (PTSMA) on remodeling in asymptomatic patients with hypertrophic obstructive cardiomyopathy (HOCM) and severe left ventricular outflow tract (LVOT) obstruction.
BACKGROUND


Symptoms justify invasive treatment in HOCM patients with LVOT obstruction. Adverse structural and functional changes (remodeling) in the heart occur preceding heart failure and sudden cardiac death. Early invasive treatment in asymptomatic patients may reverse adverse remodeling to the same extent as in symptomatic patients.
METHODS


Reverse remodeling after PTSMA in severe but asymptomatic LVOT obstruction (RASTA) study is a prospective single-blind randomized trial (ClinicalTrials.gov number: NCT04230551). Ten asymptomatic HOCM patients with an exertional LVOT gradient ≥50 mmHg (or >30 mmHg in rest) are randomized 1:1 to PTSMA versus conservative therapy, in the absence of mitral valve disease or other indications for cardiac surgery. Five symptomatic (reference group) will undergo PTSMA according to the current guidelines.
RESULTS


Remodeling is assessed using extensive cardiac imaging with transthoracic echocardiography and late gadolinium enhancement cardiac magnetic resonance at baseline and during follow-up at 1, 12, and 24 months. Extracellular volume fraction, global, and regional strain analysis, geometry, pressure gradients and changes in four-dimensional velocity mapping are primary parameters to study (reversal of) adverse remodeling.
CONCLUSIONS


The RASTA study gives insight in cardiac remodeling that may occur in asymptomatic patients after PTSMA. It will provide arguments whether to pursue (or not) a larger trial with clinical endpoints in asymptomatic HOCM patients with severe LVOT obstruction.",2020,"Ten asymptomatic HOCM patients with an exertional LVOT gradient ≥50 mmHg (or >30 mmHg in rest) are randomized 1:1 to PTSMA versus conservative therapy, in the absence of mitral valve disease or other indications for cardiac surgery.","['asymptomatic HOCM patients with severe LVOT obstruction', 'asymptomatic patients', 'asymptomatic patients with hypertrophic obstructive cardiomyopathy (HOCM) and severe left ventricular outflow tract (LVOT) obstruction', 'Ten asymptomatic HOCM patients with an exertional LVOT gradient ≥50\u2009mmHg (or >30\u2009mmHg in rest', 'asymptomatic patients with severe hypertrophic obstructive cardiomyopathy', 'Reverse remodeling after PTSMA in severe but asymptomatic LVOT obstruction (RASTA', 'HOCM patients with LVOT obstruction', 'asymptomatic patients after PTSMA']","['transcatheter septal reduction', 'percutaneous transluminal septal myocardial ablation (PTSMA', 'PTSMA versus conservative therapy', 'percutaneous transluminal septal myocardial ablation']","['Extracellular volume fraction, global, and regional strain analysis, geometry, pressure gradients and changes', 'Adverse structural and functional changes (remodeling']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C4551472', 'cui_str': 'Hypertrophic obstructive cardiomyopathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0225912', 'cui_str': 'Structure of outflow tract of left ventricle'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C2584460', 'cui_str': 'Percutaneous transluminal septal myocardial ablation'}, {'cui': 'C0344917', 'cui_str': 'Left ventricular outflow tract obstruction'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0442004', 'cui_str': 'Septal'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2584460', 'cui_str': 'Percutaneous transluminal septal myocardial ablation'}, {'cui': 'C0459914', 'cui_str': 'Conservative therapy'}]","[{'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0449829', 'cui_str': 'Geometry'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0694563,"Ten asymptomatic HOCM patients with an exertional LVOT gradient ≥50 mmHg (or >30 mmHg in rest) are randomized 1:1 to PTSMA versus conservative therapy, in the absence of mitral valve disease or other indications for cardiac surgery.","[{'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Arslan', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital Nieuwegein, Nieuwegein, The Netherlands.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Akdim', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital Nieuwegein, Nieuwegein, The Netherlands.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital Nieuwegein, Nieuwegein, The Netherlands.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.29178']
2367,32808888,Quantitative Muscle MRI Depicts Increased Muscle Mass after a Behavioral Change in Myotonic Dystrophy Type 1.,"Background Patients with myotonic dystrophy type 1 (DM1) increased their physical activity and exercise capacity following a behavioral intervention. However, it is unknown what is altered in muscles of patients with DM1 as a result of this intervention. The increased exercise capacity suggests that decelerated fat infiltration or increased muscle cross-sectional area (CSA) could be involved. Purpose To assess the effect of this activity-stimulating behavioral intervention on the lower extremity muscles of patients with DM1 with longitudinal quantitative muscle MRI. Materials and Methods In this prospective trial, participants with DM1 were randomized to a behavioral intervention ( n  = 14) or continued regular care (standard care;  n  = 13); no age-matched pairing was performed. Participants underwent MRI of the lower extremities at baseline and 10-month follow-up (January 2015 to March 2016). Fat fraction (FF), muscle CSA, and muscle water T2 (T2 water ) as markers for fat infiltration, muscle mass, and alteration in tissue water distribution (edema), respectively, were assessed with a chemical shift-encoded Dixon sequence and multiecho spin-echo sequence. Longitudinal within-group and between-group changes were assessed with paired-samples  t  tests and multivariable regression models. Results A total of 27 patients with DM1 (15 men) were evaluated. Patient age was comparable between groups (intervention, 45 years ± 13 [standard deviation]; standard care, 5 years ± 12;  P  = .96). Muscle CSA increased 5.9 cm 2  ± 7.8 in the intervention group during the 10-month follow-up ( P  = .03) and decreased 3.6 cm 2  ± 7.2 in the standard care group ( P  = .13). After 10 months, the mean difference between the groups was 9.5 cm 2  ( P  = .01). This effect was stronger in muscles with baseline FF below the mean ± standard deviation of unaffected volunteers (-0.4 cm 2  ± 0.15;  P  < .001). FF increased 0.9% ± 1.0 in the intervention group ( P  = .02) and 1.2% ± 1.2 for standard care ( P  = .02), with no between-group difference ( P  = .56). T2 water  did not change significantly in either group (intervention,  P  = .08; standard care,  P  = .88). Conclusion A behavioral intervention targeting physical activity increased lower extremity muscle cross-sectional area in patients with myotonic dystrophy, preferentially in healthy-appearing muscle. © RSNA, 2020  Online supplemental material is available for this article.",2020,"T2 water  did not change significantly in either group (intervention,  P  = .08; standard care,  P  = .88).","[' Patients with myotonic dystrophy type 1 (DM1', 'participants with DM1', 'patients with DM1 with longitudinal quantitative muscle MRI', 'patients with myotonic dystrophy, preferentially in healthy-appearing muscle', '27 patients with DM1 (15 men']","['activity-stimulating behavioral intervention', 'behavioral intervention ( n  = 14) or continued regular care (standard care;  n  = 13); no age-matched pairing', 'behavioral intervention targeting physical activity']","['physical activity and exercise capacity', 'Fat fraction (FF), muscle CSA, and muscle water T2 (T2 water ) as markers for fat infiltration, muscle mass, and alteration in tissue water distribution (edema', 'Muscle CSA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027126', 'cui_str': 'Steinert myotonic dystrophy syndrome'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0392762', 'cui_str': 'Quantitative'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1271922', 'cui_str': 'Target physical activity'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",27.0,0.0445056,"T2 water  did not change significantly in either group (intervention,  P  = .08; standard care,  P  = .88).","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Heskamp', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Okkersen', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'van Nimwegen', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Marieke J', 'Initials': 'MJ', 'LastName': 'Ploegmakers', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bassez', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Deux', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Baziel G', 'Initials': 'BG', 'LastName': 'van Engelen', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': 'Arend', 'Initials': 'A', 'LastName': 'Heerschap', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'From the Department of Radiology and Nuclear Medicine, Radboud Institute for Molecular Life Sciences (L.H., M.J.P., A.H.), and Department of Neurology, Donders Institute for Brain, Cognition and Behaviour (K.O., M.v.N., B.G.v.E.), Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, the Netherlands; Neuromuscular Reference Center, Sorbonne University, INSERM UMRS 974, AP-HP, Pitié-Salpêtrière Hospital, Paris, France (G.B.); and Department of Radiology, Henri Mondor University Hospital, Paris, France (J.F.D.).'}]",Radiology,['10.1148/radiol.2020192518']
2368,32808931,Mobile Health App (AGRIPPA) to Prevent Relapse After Successful Interdisciplinary Treatment for Patients With Chronic Pain: Protocol for a Randomized Controlled Trial.,"BACKGROUND


To facilitate adherence to adaptive pain management behaviors after interdisciplinary multimodal pain treatment, we developed a mobile health app (AGRIPPA app) that contains two behavior regulation strategies.
OBJECTIVE


The aims of this project are (1) to test the effectiveness of the AGRIPPA app on pain disability; (2) to determine the cost-effectiveness; and (3) to explore the levels of engagement and usability of app users.
METHODS


We will perform a multicenter randomized controlled trial with two parallel groups. Within the 12-month inclusion period, we plan to recruit 158 adult patients with chronic pain during the initial stage of their interdisciplinary treatment program in one of the 6 participating centers. Participants will be randomly assigned to the standard treatment condition or to the enhanced treatment condition in which they will receive the AGRIPPA app. Patients will be monitored from the start of the treatment program until 12 months posttreatment. In our primary analysis, we will evaluate the difference over time of pain-related disability between the two conditions. Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses.
RESULTS


The study was approved by the local Medical Research Ethics Committee in October 2019. As of March 20, 2020, we have recruited 88 patients.
CONCLUSIONS


This study will be the first step in systematically evaluating the effectiveness and efficiency of the AGRIPPA app. After 3 years of development and feasibility testing, this formal evaluation will help determine to what extent the app will influence the maintenance of treatment gains over time. The outcomes of this trial will guide future decisions regarding uptake in clinical practice.
TRIAL REGISTRATION


Netherlands Trial Register NL8076; https://www.trialregister.nl/trial/8076.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


DERR1-10.2196/18632.",2020,"Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses.
","['88 patients', 'Patients With Chronic Pain', '158 adult patients with chronic pain during the initial stage of their interdisciplinary treatment program in one of the 6 participating centers']","['Mobile Health App (AGRIPPA', 'AGRIPPA']","['pain disability', 'time of pain-related disability', 'health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}]",158.0,0.24399,"Other outcome measures will include health-related quality of life, illness perceptions, pain self-efficacy, app system usage data, productivity loss, and health care expenses.
","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Elbers', 'Affiliation': 'Lifestyle and Health Research Group, Healthy and Sustainable Living Research Centre, University of Applied Sciences Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Pool', 'Affiliation': 'Lifestyle and Health Research Group, Healthy and Sustainable Living Research Centre, University of Applied Sciences Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Harriët', 'Initials': 'H', 'LastName': 'Wittink', 'Affiliation': 'Lifestyle and Health Research Group, Healthy and Sustainable Living Research Centre, University of Applied Sciences Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Albère', 'Initials': 'A', 'LastName': 'Köke', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Health, Life Sciences and Medicine, Maastricht University, Maastricht, Netherlands.'}, {'ForeName': 'Else', 'Initials': 'E', 'LastName': 'Scheffer', 'Affiliation': 'Lifestyle and Health Research Group, Healthy and Sustainable Living Research Centre, University of Applied Sciences Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Smeets', 'Affiliation': 'Department of Rehabilitation Medicine, Faculty of Health, Life Sciences and Medicine, Maastricht University, Maastricht, Netherlands.'}]",JMIR research protocols,['10.2196/18632']
2369,32809075,Safety and efficacy of brilliant blue g250 (BBG) for lens capsular staining: a phase III physician-initiated multicenter clinical trial.,"PURPOSE


To evaluate the safety and efficacy of BBG (Brilliant Blue G250) for lens capsular staining during cataract surgery with continuous curvilinear capsulorhexis.
STUDY DESIGN


Prospective clinical study.
METHODS


This clinical trial enrolled 30 eyes of 30 patients who underwent cataract surgery with BBG (0.25 mg/mL Brilliant Blue G250) for capsular staining. Visualization of the lens capsule and the ease of capsulorhexis with BBG staining were evaluated in five grades (grade 0 to 4) by the Independent Data Monitoring Committee and the surgeons. The safety of BBG was also evaluated in terms of ocular and systemic tolerance for 7 days after surgery.
RESULTS


The use of BBG improved visualization of the lens capsule and complete capsulorhexis was performed in all patients. The major endpoint (Independent Data Monitoring Committee evaluation) showed that use of BBG improved visualization of the lens capsule and the ease of capsulorhexis (grades 2 to 4); the committee's grading results were similar to those of the surgeons. Frequent complications observed in more than two eyes were conjunctival injection, corneal edema and intraocular pressure elevation. No severe complications were observed in ocular and systemic evaluations.
CONCLUSION


BBG staining contributed to improved visualization of the lens capsule and aided in the completion of capsulorhexis during cataract surgery. The use of BBG for capsular staining also exhibited favorable safety results.",2020,The use of BBG improved visualization of the lens capsule and complete capsulorhexis was performed in all patients.,"['cataract surgery with continuous curvilinear capsulorhexis', '30 eyes of 30 patients who underwent cataract surgery with BBG (0.25\xa0mg/mL Brilliant Blue G250) for capsular staining']","['BBG (Brilliant Blue G250', 'brilliant blue g250 (BBG']","['BBG improved visualization of the lens capsule and complete capsulorhexis', 'BBG improved visualization of the lens capsule and the ease of capsulorhexis', 'Safety and efficacy', 'severe complications', 'ocular and systemic tolerance', 'safety of BBG', 'conjunctival injection, corneal edema and intraocular pressure elevation']","[{'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0525027', 'cui_str': 'Anterior capsulorrhexis'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0772270', 'cui_str': 'Brilliant blue FCF'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0038128', 'cui_str': 'Stain'}]","[{'cui': 'C0772270', 'cui_str': 'Brilliant blue FCF'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0229232', 'cui_str': 'Structure of lens capsule'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0525027', 'cui_str': 'Anterior capsulorrhexis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0010037', 'cui_str': 'Corneal edema'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",30.0,0.0471436,The use of BBG improved visualization of the lens capsule and complete capsulorhexis was performed in all patients.,"[{'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Hisatomi', 'Affiliation': 'Department of Ophthalmology, Chikushi Hospital, Fukuoka University, Chikushino, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Enaida', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Saga University, Saga, Japan.'}, {'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Department of Ophthalmology, School of Medicine, Kurume University, Kurume, Japan.'}, {'ForeName': 'Akito', 'Initials': 'A', 'LastName': 'Hirakata', 'Affiliation': 'Kyorin Eye Center, School of Medicine, Kyorin University, Mitaka, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Ohji', 'Affiliation': 'Department of Ophthalmology, Shiga University of Medical Science, Otsu, Japan.'}, {'ForeName': 'Kohji', 'Initials': 'K', 'LastName': 'Nishida', 'Affiliation': 'Department of Ophthalmology, Graduate School of Medicine, Osaka University, Suita, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Kubota', 'Affiliation': 'Department of Ophthalmology, Faculty of Medicine, Oita University, Yufu , Japan.'}, {'ForeName': 'Nahoko', 'Initials': 'N', 'LastName': 'Ogata', 'Affiliation': 'Department of Ophthalmology, Nara Medical University, Kashihara, Japan.'}, {'ForeName': 'Takaaki', 'Initials': 'T', 'LastName': 'Matsui', 'Affiliation': 'Ohshima Eye Hospital, Fukuoka, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Kimura', 'Affiliation': 'Department of Ophthalmology, Graduate School of Medicine, Yamaguchi University, Yamaguchi, Japan.'}, {'ForeName': 'Koh-Hei', 'Initials': 'KH', 'LastName': 'Sonoda', 'Affiliation': 'Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Uchiyama', 'Affiliation': 'Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Kishimoto', 'Affiliation': 'Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Todaka', 'Affiliation': 'Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Nakanishi', 'Affiliation': 'Kitakyushu City Hospital Organization, Kitakyushu, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Ishibashi', 'Affiliation': 'Kyushu University, 744 Motooka, Nishi-ku, Fukuoka, 819-0395, Japan. ishi@med.kyushu-u.ac.jp.'}]",Japanese journal of ophthalmology,['10.1007/s10384-020-00763-y']
2370,32809136,Conservative oxygen therapy for mechanically ventilated adults with suspected hypoxic ischaemic encephalopathy.,"PURPOSE


Liberal use of oxygen may contribute to secondary brain injury in patients with hypoxic-ischaemic encephalopathy (HIE). However, there are limited data on the effect of different oxygen regimens on survival and neurological disability in HIE patients.
METHODS


We undertook a post-hoc analysis of the 166 patients with suspected HIE enrolled in a trial comparing conservative oxygen therapy with usual oxygen therapy in 1000 mechanically ventilated ICU patients. The primary endpoint for the current analysis was death or unfavourable neurological outcome at day 180. Key secondary outcomes were day 180 mortality, and cause-specific mortality.
RESULTS


Patients with HIE allocated to conservative oxygen spent less time in the ICU with an SpO 2  ≥ 97% (26 h [interquartile range (IQR) 13-45 vs. 35 h [IQR 19-70], absolute difference, 9 h; 95% CI - 21.4 to 3.4). A total of 43 of 78 patients (55.1%) assigned to conservative oxygen and 49 of 72 patients (68.1%) assigned to usual oxygen died or had an unfavourable neurological outcome at day 180; odds ratio 0.58; 95% CI 0.3-1.12; P = 0.1 adjusted odds ratio 0.54; 95% CI 0.23-1.26; P = 0.15. A total of 37 of 86 patients (43%) assigned to conservative oxygen and 46 of 78 (59%) assigned to usual oxygen had died by day 180; odds ratio 0.53; 95% CI 0.28-0.98; P = 0.04; adjusted odds ratio 0.56; 95% CI 0.25-1.23; P = 0.15. Cause-specific mortality was similar by treatment group.
CONCLUSIONS


Conservative oxygen therapy was not associated with a statistically significant reduction in death or unfavourable neurological outcomes at day 180. The potential for important benefit or harm from conservative oxygen therapy in HIE patients is not excluded by these data.",2020,"CONCLUSIONS


Conservative oxygen therapy was not associated with a statistically significant reduction in death or unfavourable neurological outcomes at day 180.","['mechanically ventilated adults with suspected hypoxic ischaemic encephalopathy', '1000 mechanically ventilated ICU patients', '166 patients with suspected HIE enrolled in a trial comparing', 'Patients with HIE', 'HIE patients', 'patients with hypoxic-ischaemic encephalopathy (HIE']","['conservative oxygen therapy with usual oxygen therapy', 'Conservative oxygen therapy']","['day 180 mortality, and cause-specific mortality', 'survival and neurological disability', 'death or unfavourable neurological outcomes', 'Cause-specific mortality', 'death or unfavourable neurological outcome']","[{'cui': 'C0042491', 'cui_str': 'Ventilation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0752304', 'cui_str': 'Hypoxic ischemic encephalopathy'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1000.0,0.358589,"CONCLUSIONS


Conservative oxygen therapy was not associated with a statistically significant reduction in death or unfavourable neurological outcomes at day 180.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand. paul.young@ccdhb.org.nz.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Mackle', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bailey', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Beasley', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Deane', 'Affiliation': 'University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Eastwood', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Finfer', 'Affiliation': 'Division of Critical Care Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Freebairn', 'Affiliation': 'Intensive Care Unit, Hawkes Bay Hospital, Hastings, New Zealand.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'King', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Linke', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'Intensive Care Unit, Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Rakshit', 'Initials': 'R', 'LastName': 'Panwar', 'Affiliation': 'Intensive Care Unit, John Hunter Hospital, New Lambton Heights, NSW, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Intensive care medicine,['10.1007/s00134-020-06196-y']
2371,32809161,Neck dissection with harmonic instruments and electrocautery: a prospective comparative study.,"BACKGROUND


Harmonic instruments are becoming popular in head and neck surgeries. In this prospective, randomized study, the efficacy of the harmonic instruments and electrosurgical technique is compared.
MATERIALS AND METHODS


A total of 48 patients undergoing unilateral neck dissection were divided into two groups. In one group, surgery was performed using conventional hemostatic instruments while in the other, only harmonic instruments were used. The two techniques were then compared with regard to intra- and post-operative blood loss, complications in operating time, drain, tracheotomy and nasogastric tube duration, and post-operative hospital stay.
RESULTS


Differences in operative time (P = 0.647), total suction drainage (P = 0.362) and time that drains (P = 0.404), nasogastric tube (P = 0.378), and tracheotomy (P = 0.052) were kept in place and proved not significant. The average blood loss during surgery was significantly greater in the CH group (P = 0.003) as the number of hemoclips and resorbable ligature used (P = 0.002).
CONCLUSIONS


In contrast to what has been reported up to now, our study did not reveal a net advantage in the use of harmonic instruments with respect to classical instruments in terms of surgical outcome. On the contrary, harmonic tools had a higher complication rate (i.e., salivary fistula and lymphatic leak) probably due to the decreased ability of this instruments to permanently close glandular structures and lymphatic ducts. In these cases, a closure technique such as electrocautery or classic knot-tying should be used.",2020,"RESULTS


Differences in operative time (P = 0.647), total suction drainage (P = 0.362) and time that drains (P = 0.404), nasogastric tube (P = 0.378), and tracheotomy (P = 0.052) were kept in place and proved not significant.",['48 patients undergoing unilateral neck dissection'],"['Neck dissection with harmonic instruments and electrocautery', 'harmonic instruments and electrosurgical technique']","['average blood loss', 'operative blood loss, complications in operating time, drain, tracheotomy and nasogastric tube duration, and post-operative hospital stay', 'operative time', 'total suction drainage', 'complication rate', 'nasogastric tube']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}]","[{'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0040590', 'cui_str': 'Tracheostomy'}, {'cui': 'C0085678', 'cui_str': 'Nasogastric tube'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}]",48.0,0.0212225,"RESULTS


Differences in operative time (P = 0.647), total suction drainage (P = 0.362) and time that drains (P = 0.404), nasogastric tube (P = 0.378), and tracheotomy (P = 0.052) were kept in place and proved not significant.","[{'ForeName': 'Luigi Angelo', 'Initials': 'LA', 'LastName': 'Vaira', 'Affiliation': 'Maxillofacial Surgery Operative Unit, University Hospital of Sassari, Viale San Pietro 43B, 07100, Sassari, Italy. luigi.vaira@gmail.com.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'De Riu', 'Affiliation': 'Maxillofacial Surgery Operative Unit, University Hospital of Sassari, Viale San Pietro 43B, 07100, Sassari, Italy.'}, {'ForeName': 'Enrica', 'Initials': 'E', 'LastName': 'Ligas', 'Affiliation': 'Maxillofacial Surgery Operative Unit, University Hospital of Sassari, Viale San Pietro 43B, 07100, Sassari, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Deiana', 'Affiliation': 'Direction, Hygiene and Hospital Infection Control Operative Unit, University Hospital of Sassari, Via Padre Manzella 4, 07100, Sassari, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Vacca', 'Affiliation': 'Maxillofacial Surgery Operative Unit, University Hospital of Sassari, Viale San Pietro 43B, 07100, Sassari, Italy.'}, {'ForeName': 'Olindo', 'Initials': 'O', 'LastName': 'Massarelli', 'Affiliation': 'Maxillofacial Surgery Operative Unit, University Hospital of Sassari, Viale San Pietro 43B, 07100, Sassari, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Piombino', 'Affiliation': 'Maxillofacial Surgery Operative Unit, University of Naples ""Federico II"" Hospital, Via Pansini 5, 80131, Napoli, Italy.'}, {'ForeName': 'Bruno Carlo', 'Initials': 'BC', 'LastName': 'Brevi', 'Affiliation': 'Maxillofacial Surgery Operative Unit, University Hospital of Pisa, Via Roma 67, 56126, Pisa, Italy.'}]",Oral and maxillofacial surgery,['10.1007/s10006-020-00897-w']
2372,32803156,"A Randomized Clinical Trial of Oxytocin or Galantamine in Schizophrenia: Assessing the Impact on Behavioral, Lexical, and Self-Report Indicators of Social Affiliation.","Prior studies examining the impact of oxytocin on negative symptoms in schizophrenia have yielded mixed results. The current study explored whether oxytocin can improve more proximal indicators of social affiliation as indicated by changes in behavior, language and subjective indices of social affiliation among individuals with schizophrenia spectrum disorders during a role-play designed to elicit affiliative responses. We tested the hypothesis that daily intranasal oxytocin administered for 6 weeks would improve social affiliation as manifested by increased social skill ratings, use of positive, affiliative, and social words, and subjective responses from a previously published randomized controlled trial. Forty outpatients with schizophrenia or schizoaffective disorder were randomized to the oxytocin, galantamine, or placebo group and completed affiliative role-plays and self-report questionnaires of affect, reactions to the affiliative confederate, and willingness to interact at baseline and post-treatment. Results demonstrated that oxytocin was not effective at improving behavioral or subjective indicators of social affiliation. This study adds to a growing literature that the prosocial effects of oxytocin in schizophrenia are limited or null.",2020,"We tested the hypothesis that daily intranasal oxytocin administered for 6 weeks would improve social affiliation as manifested by increased social skill ratings, use of positive, affiliative, and social words, and subjective responses from a previously published randomized controlled trial.","['individuals with schizophrenia spectrum disorders', 'Forty outpatients with schizophrenia or schizoaffective disorder', 'Schizophrenia']","['oxytocin', 'oxytocin, galantamine, or placebo group and completed affiliative role-plays and self-report questionnaires of affect, reactions to the affiliative confederate, and willingness to interact at baseline and post-treatment', 'Oxytocin or Galantamine', 'intranasal oxytocin']","['behavioral or subjective indicators of social affiliation', 'social skill ratings, use of positive, affiliative, and social words, and subjective responses', 'social affiliation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0016967', 'cui_str': 'Galantamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]",40.0,0.055237,"We tested the hypothesis that daily intranasal oxytocin administered for 6 weeks would improve social affiliation as manifested by increased social skill ratings, use of positive, affiliative, and social words, and subjective responses from a previously published randomized controlled trial.","[{'ForeName': 'Kristen R', 'Initials': 'KR', 'LastName': 'Dwyer', 'Affiliation': 'Department of Psychology, University of Maryland College Park, Biology/Psychology Building, College Park, MD.'}, {'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Andrea', 'Affiliation': 'Department of Psychology, University of Maryland College Park, Biology/Psychology Building, College Park, MD.'}, {'ForeName': 'Christina L G', 'Initials': 'CLG', 'LastName': 'Savage', 'Affiliation': 'Department of Psychology, University of Maryland College Park, Biology/Psychology Building, College Park, MD.'}, {'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Orth', 'Affiliation': 'Department of Psychology, University of Maryland College Park, Biology/Psychology Building, College Park, MD.'}, {'ForeName': 'LeeAnn', 'Initials': 'L', 'LastName': 'Shan', 'Affiliation': 'Department of Psychology, University of Maryland, Baltimore, MD.'}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Strauss', 'Affiliation': 'Department of Psychology, University of Georgia, Athens, GA.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Adams', 'Affiliation': 'Maryland Psychiatric Research Center and Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Deanna L', 'Initials': 'DL', 'LastName': 'Kelly', 'Affiliation': 'Maryland Psychiatric Research Center and Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Weiner', 'Affiliation': 'Maryland Psychiatric Research Center and Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Gold', 'Affiliation': 'Maryland Psychiatric Research Center and Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'McMahon', 'Affiliation': 'Maryland Psychiatric Research Center and Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Carpenter', 'Affiliation': 'Maryland Psychiatric Research Center and Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Buchanan', 'Affiliation': 'Maryland Psychiatric Research Center and Department of Psychiatry, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jack J', 'Initials': 'JJ', 'LastName': 'Blanchard', 'Affiliation': 'Department of Psychology, University of Maryland College Park, Biology/Psychology Building, College Park, MD.'}]",Schizophrenia bulletin open,['10.1093/schizbullopen/sgaa001']
2373,32803161,Interaction of Cannabis Use Disorder and Striatal Connectivity in Antipsychotic Treatment Response.,"Antipsychotic (AP) medications are the mainstay for the treatment of schizophrenia spectrum disorders (SSD), but their efficacy is unpredictable and widely variable. Substantial efforts have been made to identify prognostic biomarkers that can be used to guide optimal prescription strategies for individual patients. Striatal regions involved in salience and reward processing are disrupted as a result of both SSD and cannabis use, and research demonstrates that striatal circuitry may be integral to response to AP drugs. In the present study, we used functional magnetic resonance imaging (fMRI) to investigate the relationship between a history of cannabis use disorder (CUD) and a striatal connectivity index (SCI), a previously developed neural biomarker for AP treatment response in SSD. Patients were part of a 12-week randomized, double-blind controlled treatment study of AP drugs. A sample of 48 first-episode SSD patients with no more than 2 weeks of lifetime exposure to AP medications, underwent a resting-state fMRI scan pretreatment. Treatment response was defined a priori as a binary (response/nonresponse) variable, and a SCI was calculated in each patient. We examined whether there was an interaction between lifetime CUD history and the SCI in relation to treatment response. We found that CUD history moderated the relationship between SCI and treatment response, such that it had little predictive value in SSD patients with a CUD history. In sum, our findings highlight that biomarker development can be critically impacted by patient behaviors that influence neurobiology, such as a history of CUD.",2020,"We found that CUD history moderated the relationship between SCI and treatment response, such that it had little predictive value in SSD patients with a CUD history.","['SSD patients with a CUD history', 'A sample of 48 first-episode SSD patients with no more than 2 weeks of lifetime exposure to AP medications, underwent a resting-state fMRI scan pretreatment', 'schizophrenia spectrum disorders (SSD']","['Antipsychotic (AP) medications', 'functional magnetic resonance imaging (fMRI']",[],"[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",[],48.0,0.0388796,"We found that CUD history moderated the relationship between SCI and treatment response, such that it had little predictive value in SSD patients with a CUD history.","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Blair Thies', 'Affiliation': 'Division of Psychiatry Research, Zucker Hillside Hospital, Glen Oaks, NY.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'DeRosse', 'Affiliation': 'Division of Psychiatry Research, Zucker Hillside Hospital, Glen Oaks, NY.'}, {'ForeName': 'Deepak K', 'Initials': 'DK', 'LastName': 'Sarpal', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Argyelan', 'Affiliation': 'Division of Psychiatry Research, Zucker Hillside Hospital, Glen Oaks, NY.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Fales', 'Affiliation': 'Division of Psychiatry Research, Zucker Hillside Hospital, Glen Oaks, NY.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Gallego', 'Affiliation': 'Division of Psychiatry Research, Zucker Hillside Hospital, Glen Oaks, NY.'}, {'ForeName': 'Delbert G', 'Initials': 'DG', 'LastName': 'Robinson', 'Affiliation': 'Division of Psychiatry Research, Zucker Hillside Hospital, Glen Oaks, NY.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Lencz', 'Affiliation': 'Division of Psychiatry Research, Zucker Hillside Hospital, Glen Oaks, NY.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Homan', 'Affiliation': 'Division of Psychiatry Research, Zucker Hillside Hospital, Glen Oaks, NY.'}, {'ForeName': 'Anil K', 'Initials': 'AK', 'LastName': 'Malhotra', 'Affiliation': 'Division of Psychiatry Research, Zucker Hillside Hospital, Glen Oaks, NY.'}]",Schizophrenia bulletin open,['10.1093/schizbullopen/sgaa014']
2374,31813763,A pharmacist-led medicines review intervention in community-dwelling Māori older adults- a feasibility study protocol.,"BACKGROUND


Pharmacists have a role to play in supporting the optimal use of medicines to ensure older adults receive therapeutic benefit whilst minimising medicines-related harm. In Aotearoa New Zealand (NZ), Māori (Indigenous people of NZ) experience inequities in the determinants of health, including access to medicines, resulting in increased morbidity, earlier onset of chronic conditions and reduced life expectancy. This study aims to test the feasibility of a pharmacist-led medicines review intervention in community-dwelling Māori older adults.
METHOD


This is a non-randomised, non-controlled feasibility study undertaken within a kaupapa Māori methodological framework which supports the right of Māori to be included throughout the research process and seeks to potentiate transformational, positive change for Māori. The research pharmacist will recruit 30 participants (Māori; 55 years or older; community-dwelling). Participants will undergo a medicines education session with the pharmacist (medicines reconciliation, medicines information, well-being goal setting), with the option to proceed to a medicines optimisation session that includes the participant, pharmacist and primary prescriber (review of potentially inappropriate prescribing (PIP); medicines management plan development). Primary outcomes: participant and prescriber acceptability of intervention. Secondary outcomes include baseline and post-intervention medicines knowledge, PIP and quality of life scores, and number of changes made to the medicines regimen.
ETHICS AND DISSEMINATION


Ethical approval was granted by the Northern B Health and Disability Committee (9/NTB/106). Study results will be disseminated to various stakeholders including Māori communities, health practitioners and providers, and researchers through meetings and conference presentations, lay summaries and peer-reviewed journals. This study is an example of health service design, delivery and evaluation, informed by Indigenous knowledge and methodology, developed explicitly to address inequities in health outcomes for, and with, Māori and will inform the decision to proceed to a randomised controlled trial to test the effect of this intervention.
TRIAL REGISTRATION NUMBER


ACTRN12619001070123.",2020,"Secondary outcomes include baseline and post-intervention medicines knowledge, PIP and quality of life scores, and number of changes made to the medicines regimen.
","['30 participants (Māori; 55 years or older; community-dwelling', 'community-dwelling Māori older adults']","['pharmacist-led medicines review intervention', 'medicines optimisation session that includes the participant, pharmacist and primary prescriber (review of potentially inappropriate prescribing (PIP); medicines management plan development']","['baseline and post-intervention medicines knowledge, PIP and quality of life scores, and number of changes made to the medicines regimen', 'prescriber acceptability of intervention']","[{'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0699752', 'cui_str': 'Review of'}, {'cui': 'C2936303', 'cui_str': 'Inappropriate Prescribing'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3839881', 'cui_str': 'Change made'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",30.0,0.0784306,"Secondary outcomes include baseline and post-intervention medicines knowledge, PIP and quality of life scores, and number of changes made to the medicines regimen.
","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Hikaka', 'Affiliation': 'School of Pharmacy, University of Auckland, New Zealand; Waitematā District Health Board, Auckland, New Zealand. Electronic address: j.hikaka@auckland.ac.nz.'}, {'ForeName': 'Carmel', 'Initials': 'C', 'LastName': 'Hughes', 'Affiliation': ""School of Pharmacy, Queen's University, Belfast, UK.""}, {'ForeName': 'Rhys', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Te Kupenga Hauora Māori, University of Auckland, New Zealand.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'Connolly', 'Affiliation': 'Waitematā District Health Board, Auckland, New Zealand; Freemasons Department of Geriatric Medicine, University of Auckland, New Zealand.'}, {'ForeName': 'Nataly', 'Initials': 'N', 'LastName': 'Martini', 'Affiliation': 'School of Pharmacy, University of Auckland, New Zealand.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2019.12.004']
2375,32809261,Serum Potassium in the PARADIGM-HF trial.,"BACKGROUND


We studied the association between potassium and outcomes, the effect of sacubitril/valsartan on potassium, and whether potassium level modified the effect of sacubitril/valsartan in patients with heart failure and a reduced ejection fraction in PARADIGM-HF.
AIMS


We examined several outcomes including cardiovascular death, sudden-death, pump-failure death, non-cardiovascular death and heart failure hospitalization.
METHODS


8399 patients were randomized to either enalapril or sacubitril/valsartan. Potassium at randomization and follow-up was examined as a continuous and categorical variable (≤3.5, 3.6-4.0, 4.1-4.9, 5.0-5.4, and ≥5.5mmol/L) in various statistical models. Hyperkalemia was defined as K +  ≥5.5mmol/L and hypokalemia as K +  ≤3.5mmol/L.
RESULTS


Compared to potassium 4.1-4.9mmol/L, both hypokalemia (HR 2.40, 95%CI 1.84-3.14) and hyperkalemia (HR 1.42, 1.10-1.83) were associated with a higher risk of cardiovascular death. However, potassium abnormalities were similarly associated with sudden death and pump failure death, as well as non-cardiovascular death and heart failure hospitalization. Sacubitril/valsartan had no effect on potassium overall. The benefit of sacubitril/valsartan over enalapril was consistent across the range of baseline potassium.
CONCLUSIONS


Although both higher and lower potassium were independent predictors of cardiovascular death, potassium abnormalities may mainly be markers rather than mediators of risk of death.",2020,"However, potassium abnormalities were similarly associated with sudden death and pump failure death, as well as non-cardiovascular death and heart failure hospitalization.","['patients with heart failure and a reduced ejection fraction in PARADIGM-HF', '8399 patients']","['Sacubitril/valsartan', 'sacubitril/valsartan', 'enalapril', 'enalapril or sacubitril/valsartan', 'Potassium']","['non-cardiovascular death and heart failure hospitalization', 'Hyperkalemia', 'hyperkalemia', 'hypokalemia', 'cardiovascular death, sudden-death, pump-failure death, non-cardiovascular death and heart failure hospitalization', 'potassium overall', 'sudden death and pump failure death', 'Serum Potassium', 'risk of cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C4033631', 'cui_str': 'valsartan and sacubitril'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0011071', 'cui_str': 'Sudden death'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",8399.0,0.162291,"However, potassium abnormalities were similarly associated with sudden death and pump failure death, as well as non-cardiovascular death and heart failure hospitalization.","[{'ForeName': 'João Pedro', 'Initials': 'JP', 'LastName': 'Ferreira', 'Affiliation': 'National Institute of Health and Medical Research Center for Clinical Multidisciplinary Research, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France.'}, {'ForeName': 'Ulrik M', 'Initials': 'UM', 'LastName': 'Mogensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100, Copenhagen, Denmark.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, United States of America.""}, {'ForeName': 'Jean-Lucien', 'Initials': 'JL', 'LastName': 'Rouleau', 'Affiliation': 'Montreal Heart Institute, Montreal, Quebec, Canada.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina and Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, South Carolina, United States of America.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': 'National Institute of Health and Medical Research Center for Clinical Multidisciplinary Research, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': 'National Institute of Health and Medical Research Center for Clinical Multidisciplinary Research, INSERM U1116, University of Lorraine, Regional University Hospital of Nancy, French Clinical Research Infrastructure Network Investigation Network Initiative-Cardiovascular and Renal Clinical Trialists, Nancy, France.'}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute Baylor University Medical Center, 621 N. Hall Street, Dallas, Texas, United States of America.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts, United States of America.""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.'}]",European journal of heart failure,['10.1002/ejhf.1987']
2376,32809271,Cardiovascular safety of fenfluramine in the treatment of Dravet syndrome: Analysis of an ongoing long-term open-label safety extension study.,"OBJECTIVE


Fenfluramine, which was previously approved as a weight loss drug, was withdrawn in 1997 when reports of cardiac valvulopathy emerged. The present study was conducted in part to characterize the cardiovascular safety profile of low-dose fenfluramine when used in a pediatric population to reduce seizure frequency in patients with Dravet syndrome.
METHODS


Patients 2- to 18-years-old with Dravet syndrome who had completed any of three randomized, placebo-controlled clinical trials of fenfluramine were offered enrollment in this open-label extension (OLE) study. All patients were treated with fenfluramine starting at a dose of 0.2 mg/kg/day (oral solution dosed twice per day), which was titrated to maximal effect with a dose limit of 0.7 mg/kg/day (maximum 26 mg/day) or 0.4 mg/kg/day (maximum 17 mg/day) in patients receiving concomitant stiripentol. Standardized echocardiographic examinations were conducted at Week 4 or 6 and then every 3 months during the OLE study to monitor cardiac valve function and structure and pulmonary artery pressure. The primary end point for the echocardiography analysis was the number of patients who developed valvular heart disease or pulmonary artery hypertension (PAH) during treatment.
RESULTS


A total of 232 patients were enrolled in the study. The average age of patients was 9.1 ± 4.7 years, and 55.2% were male. The median duration of treatment with fenfluramine was 256 days (range = 58-634 days), and the mean dose of fenfluramine was 0.41 mg/kg/day. No cases of valvular heart disease or PAH were observed.
SIGNIFICANCE


Longitudinal echocardiography over a median 8.4 months of treatment with fenfluramine suggests a low risk of developing cardiac valvulopathy and PAH when used to treat pediatric patients with Dravet syndrome.",2020,"The median duration of treatment with fenfluramine was 256 days (range = 58-634 days), and the mean dose of fenfluramine was 0.41 mg/kg/day.","['Patients', '2- to 18-years-old with Dravet syndrome who had completed any of three randomized', '232 patients were enrolled in the study', 'The average age of patients was 9.1\xa0±\xa04.7\xa0years, and 55.2% were male', 'patients with Dravet syndrome', 'pediatric patients with Dravet syndrome', 'Dravet syndrome']","['fenfluramine', 'Fenfluramine', 'concomitant stiripentol', 'placebo']","['number of patients who developed valvular heart disease or pulmonary artery hypertension (PAH', 'seizure frequency', 'median duration', 'valvular heart disease or PAH', 'Cardiovascular safety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0751122', 'cui_str': 'Severe myoclonic epilepsy in infancy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0011786', 'cui_str': 'Dexfenfluramine'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0075262', 'cui_str': 'stiripentol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018824', 'cui_str': 'Heart valve disorder'}, {'cui': 'C2973725', 'cui_str': 'Pulmonary arterial hypertension'}, {'cui': 'C0030123', 'cui_str': '4-Aminohippuric Acid'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",232.0,0.0953155,"The median duration of treatment with fenfluramine was 256 days (range = 58-634 days), and the mean dose of fenfluramine was 0.41 mg/kg/day.","[{'ForeName': 'Wyman W', 'Initials': 'WW', 'LastName': 'Lai', 'Affiliation': ""Children's Hospital of Orange County, Orange, CA, USA.""}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Galer', 'Affiliation': 'Zogenix, Inc., Emeryville, CA, USA.'}, {'ForeName': 'Pierre C', 'Initials': 'PC', 'LastName': 'Wong', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, CA, USA.""}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Farfel', 'Affiliation': 'Zogenix, Inc., Emeryville, CA, USA.'}, {'ForeName': 'Milka', 'Initials': 'M', 'LastName': 'Pringsheim', 'Affiliation': 'Department of Pediatric Cardiology, German Heart Centre Munich, Munich, Germany.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Keane', 'Affiliation': 'Temple University Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Zogenix, Inc., Emeryville, CA, USA.'}]",Epilepsia,['10.1111/epi.16638']
2377,32809289,[Cholecalciferol supplementation improves secondary hyperparathyroidism control in renal transplant recipient].,"Introduction:  Vitamin D deficiency (25(OH)D <30 ng/mL) in renal transplant recipients (RTRs) is a frequent finding and represents an important component in the pathogenesis of secondary hyperparathyroidism (SHPT). Therefore, its more systematic supplementation is recommended. We herein report our experience on the impact of cholecalciferol supplementation on PTH and 25(OH)D levels in a group of RTRs with 25(OH)D <30 ng/mL and SHPT.  Patients and Methods:  For this purpose, 52 RTRs with SHPT were treated with cholecalciferol at the fixed dose of 25,000 IU p.o. weekly for 12 months. For the control group we selected 23 RTRs with SHPT and 25(OH)D levels <30 ng/mL. Every 6 weeks eGFR, sCa and sPO4 levels were evaluated; PTH, 25(OH)D, FECa e TmPO 4 were evaluated every 6 months.  Results:  At baseline, the two groups had similar clinical characteristics and biohumoral parameters. Parathormone was negatively correlated with 25(OH)D levels (r=-0.250; P <0.001) and TmPO4 values (r=-0.425; P<0.0001). At F-U there was a significant reduction in PTH levels in the supplemented group, from 131 ± 46 to 103 ± 42 pg/mL (P<0.001), while vitamin D levels, TmPO4 values, PO4 and sCa levels increased significantly, from 14.9 ± 6.5 to 37.9 ± 13.1 ng/mL (P<0.001), from 1.9 ± 0.7 to 2.6 ± 0.7 mg/dL (P<0.001), from 3.1 ± 0.5 to 3.5 ± 0.5 mg/dL (P<0.001), and from 9.3 ± 0.5 to 9.6 ± 0.4 (P<0.01), respectively. During the study there were no episodes of hypercalcaemia and/or hypercalciuria, while 25(OH)D levels always remained <100 ng/mL. In the control group, at F-U, PTH levels increased from 132 ± 49 to 169 ± 66 pg/ml (P <0.05), while 25(OH)D levels remained stable at <30 ng/mL.  Conclusions:  Vitamin D deficiency in RTRs is very frequent. Cholecalciferol supplementation is associated with a better control of SHPT and a correction of vitamin D deficiency in most patients, representing an effective, safe and inexpensive therapeutic approach to IPS.",2020,"At F-U there was a significant reduction in PTH levels in the supplemented group, from 131 ± 46 to 103 ± 42 pg/mL (P<0.001), while vitamin D levels, TmPO4 values, PO4 and sCa levels increased significantly, from 14.9 ± 6.5 to 37.9 ± 13.1 ng/mL (P<0.001), from 1.9 ± 0.7 to 2.6 ± 0.7 mg/dL (P<0.001), from 3.1 ± 0.5 to 3.5 ± 0.5 mg/dL (P<0.001), and from 9.3 ± 0.5 to 9.6 ± 0.4 (P<0.01), respectively.","['renal transplant recipient', 'renal transplant recipients (RTRs', '52 RTRs with SHPT', 'a group of RTRs with 25(OH)D <30 ng/mL and SHPT']","['cholecalciferol supplementation', 'Vitamin D deficiency (25(OH)D <30 ng/mL', 'Cholecalciferol supplementation', 'cholecalciferol']","['25(OH)D levels', 'PTH levels', 'eGFR, sCa and sPO4 levels', 'vitamin D levels, TmPO4 values, PO4 and sCa levels', 'SHPT and 25(OH)D levels', 'TmPO4 values', 'secondary hyperparathyroidism control', 'hypercalcaemia and/or hypercalciuria, while 25(OH)D levels always', 'PTH and 25(OH)D levels']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020063', 'cui_str': 'PTH protein, human'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0020503', 'cui_str': 'Secondary hyperparathyroidism'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0020438', 'cui_str': 'Hypercalciuria'}]",,0.0697246,"At F-U there was a significant reduction in PTH levels in the supplemented group, from 131 ± 46 to 103 ± 42 pg/mL (P<0.001), while vitamin D levels, TmPO4 values, PO4 and sCa levels increased significantly, from 14.9 ± 6.5 to 37.9 ± 13.1 ng/mL (P<0.001), from 1.9 ± 0.7 to 2.6 ± 0.7 mg/dL (P<0.001), from 3.1 ± 0.5 to 3.5 ± 0.5 mg/dL (P<0.001), and from 9.3 ± 0.5 to 9.6 ± 0.4 (P<0.01), respectively.","[{'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Massimetti', 'Affiliation': 'Centro di Riferimento di Nefrologia e Dialisi, Ospedale Belcolle, Viterbo, Italia.'}, {'ForeName': 'Gea', 'Initials': 'G', 'LastName': 'Imperato', 'Affiliation': 'Centro di Riferimento di Nefrologia e Dialisi, Ospedale Belcolle, Viterbo, Italia.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Feriozzi', 'Affiliation': 'Centro di Riferimento di Nefrologia e Dialisi, Ospedale Belcolle, Viterbo, Italia.'}]",Giornale italiano di nefrologia : organo ufficiale della Societa italiana di nefrologia,[]
2378,32804527,How far can stigma-based empathy reach? Effects of societal (in)equity of LGB people on their allyship with transgender and Black people.,"The shared experience of societal discrimination and affirmation can provide a basis for empathy among members of different marginalized groups. However, the potential mechanisms and moderating conditions involved in this process have been little studied. This experiment examined how perceived societal (in)equity of one's own group may influence one's reaction to other marginalized groups. We randomly assigned 310 cisgender White lesbian, gay, and bisexual (LGB) adults to conditions varying in LGB (in)equity salience (discrimination, affirmation, control) and in the target outgroup identity (transgender, Black). Participants completed a survey assessing thoughts, feelings, and behaviors related to the outgroup, that is, indicators of allyship. Based on the emerging theory of stigma-based solidarity, we expected LGB discrimination to improve intergroup relations with transgender people (i.e. a group readily sharing a common superordinate identity with LGB people) but worsen relations with Black people (i.e. a group not readily sharing a common superordinate identity). Counter to expectations, allyship variables were not predicted by discrimination as a main effect or in interaction with outgroup identity. However, we found support for the mediating role of emotions in explaining the indirect effect of discrimination on allyship. For example, discrimination produced greater outgroup identification by elevating negative affect, but only when the outgroup was transgender people. Results for transgender and Black targets converged for outcomes requiring participants to consider societal injustice toward the outgroup. We observed only one effect for affirmation: It reduced LGB people's empathic anger for both transgender and Black people. Results may inform efforts of coalition building. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Counter to expectations, allyship variables were not predicted by discrimination as a main effect or in interaction with outgroup identity.","['310 cisgender White lesbian, gay, and bisexual (LGB) adults to', 'LGB people on their allyship with transgender and Black people']","['conditions varying in LGB (in)equity salience (discrimination, affirmation, control) and in the target outgroup identity (transgender, Black']",['affirmation'],"[{'cui': 'C5191352', 'cui_str': '310'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0242659', 'cui_str': 'Female homosexual'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0242659', 'cui_str': 'Female homosexual'}, {'cui': 'C0019898', 'cui_str': 'Queers'}, {'cui': 'C0005639', 'cui_str': 'Bisexuality'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0558141', 'cui_str': 'Transsexual'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}]",[],310.0,0.0396538,"Counter to expectations, allyship variables were not predicted by discrimination as a main effect or in interaction with outgroup identity.","[{'ForeName': 'Eddie S K', 'Initials': 'ESK', 'LastName': 'Chong', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Mohr', 'Affiliation': 'Department of Psychology.'}]",The American journal of orthopsychiatry,['10.1037/ort0000510']
2379,32804837,Comparative study of allicin-containing quadruple therapy vs. bismuth-containing quadruple therapy for the treatment of Helicobacter pylori infection: a prospective randomized study.,"BACKGROUND


Bismuth has antimicrobial activity and can improve the efficacy of triple Helicobacter pylori (H. pylori) therapy. Allicin added to conventional therapy for H. pylori infection also improves H. pylori eradication rates. Thus, this study aims to evaluate and compare the efficacy, safety and tolerability of allicin-containing quadruple therapy and bismuth-containing quadruple therapy and to investigate the factors that affect the eradication rates.
METHODS


Two hundred twenty H. pylori-infected patients were included and randomly (1:1) assigned to 14-day quadruple therapy: ilaprazole (5 mg bid), doxycycline (100 mg bid), and furazolidone (100 mg bid) with an allicin soft capsule (40 mg of DATS tid) (IDFA) or colloidal bismuth tartrate (220 mg of elemental bismuth bid) (IDFB). Eradication was confirmed by urea breath tests. Symptom improvement, adverse events, and adherence were assessed by a questionnaire.
RESULTS


In the intention-to-treat and per-protocol analysis, the eradication rates for IDFA and IDFB groups were 87.5% (70/80) vs. 86.3% (69/80, P = 0.815) and 91.9% (68/74) vs. 91.8% (67/73, P = 0.980) as first-line therapies; 83.3% (25/30) vs. 83.3% (25/30, P = 1) and 89.3% (25/28) vs. 88.9% (24/27, P = 1) as second-line therapies. Symptom improvement rates were 96.1% and 97.0% for IDFA and IDFB (P = 1). The adverse event rates were 10.9% in IDFA and 14.5% in IDFB groups (P = 0.418). Nausea occurred frequently in IDFB than IDFA (1.8% vs. 8.2%, P = 0.030). Smoking and sharing utensils significantly affected the efficacy.
CONCLUSION


Allicin-containing quadruple therapy might be regarded as a promising alternative to bismuth-containing quadruple therapy in H. pylori eradication.",2020,Symptom improvement rates were 96.1% and 97.0% for IDFA and IDFB (P = 1).,"['Two hundred twenty H. pylori-infected patients', 'Helicobacter pylori infection']","['doxycycline', 'Allicin-containing quadruple therapy', 'allicin-containing quadruple therapy and bismuth-containing quadruple therapy', '14-day quadruple therapy: ilaprazole', 'furazolidone', 'allicin soft capsule (40 mg of DATS tid) (IDFA) or colloidal bismuth tartrate', 'allicin-containing quadruple therapy vs. bismuth-containing quadruple therapy']","['efficacy, safety and tolerability', 'Symptom improvement rates', 'Symptom improvement, adverse events, and adherence', 'Nausea', 'adverse event rates', 'H. pylori eradication rates', 'eradication rates']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0051200', 'cui_str': 'allicin'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1881129', 'cui_str': 'ilaprazole'}, {'cui': 'C0016855', 'cui_str': 'Furazolidone'}, {'cui': 'C1273639', 'cui_str': 'Soft capsule'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}, {'cui': 'C0053781', 'cui_str': 'bismoverol'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}]",220.0,0.0405258,Symptom improvement rates were 96.1% and 97.0% for IDFA and IDFB (P = 1).,"[{'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Gastroenterology, the Third Xiangya Hospital of Central South University, Changsha, Hunan Province, People's Republic of China.""}, {'ForeName': 'Xiu-Juan', 'Initials': 'XJ', 'LastName': 'Xia', 'Affiliation': ''}, {'ForeName': 'Lin-Fang', 'Initials': 'LF', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Jing-Shu', 'Initials': 'JS', 'LastName': 'Chi', 'Affiliation': ''}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wu', 'Affiliation': ''}, {'ForeName': 'Xiao-Ran', 'Initials': 'XR', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'De-Lin', 'Initials': 'DL', 'LastName': 'Tian', 'Affiliation': ''}, {'ForeName': 'Kai-Xiao', 'Initials': 'KX', 'LastName': 'Kun', 'Affiliation': ''}, {'ForeName': 'Ren-Jie', 'Initials': 'RJ', 'LastName': 'Gong', 'Affiliation': ''}, {'ForeName': 'Xiao-Ming', 'Initials': 'XM', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Can-Xia', 'Initials': 'CX', 'LastName': 'Xu', 'Affiliation': ''}]",European journal of gastroenterology & hepatology,['10.1097/MEG.0000000000001896']
2380,32804843,"A randomized, double-blind, placebo-controlled pilot study to evaluate the efficacy and tolerability of a novel oral bioadhesive formulation for the treatment of nonerosive reflux disease-related symptoms.","OBJECTIVE


The use of antisecretory drugs can provide symptomatic relief in 70-80% of patients suffering from gastro-oesophageal reflux disease (GORD), although this benefit is reduced by 20-30% in the case of nonerosive reflux disease (NERD). The current study evaluates the efficacy and safety of a patented oral formulation (liquid sachets containing hyaluronic acid, a mixture of amino acids including proline, hydroxyl-proline and glutamine, and rice extract dispersed in a bioadhesive polymer matrix) for relieving the symptoms of NERD.
METHODS


A single-centre, randomized, double-blind, parallel group, placebo-controlled clinical study was performed. Patients who experienced at least three episodes of moderate-severity heartburn during the 7-day run-in period were included and treated with three liquid sachets per day for 14 days. The primary objective was to evaluate the proportion of patients with at least a three-point reduction in the total symptom score (TSS).
RESULTS


Overall, 20 patients were randomized to receive the investigational product and 20 to receive the placebo. At the end of treatment, a three-point reduction in the TSS was achieved by 95% of patients treated with the investigational product and by 20% of patients treated with placebo (P < 0.0001). No adverse events were reported.
CONCLUSION


The investigational product showed a statistically significant superiority to the placebo in relieving common symptoms in patients with NERD. Future studies will be aimed at clarifying the hypothesis that this symptomatic benefit is related to the strengthening of the oesophageal barrier against the damage induced by gastric contents.",2020,"No adverse events were reported.
","['patients with NERD', '70-80% of patients suffering from gastro-oesophageal reflux disease (GORD', 'nonerosive reflux disease-related symptoms', '20 patients']","['novel oral bioadhesive formulation', 'patented oral formulation (liquid sachets containing hyaluronic acid, a mixture of amino acids including proline, hydroxyl-proline and glutamine, and rice extract', 'placebo']","['symptomatic relief', 'total symptom score (TSS', 'moderate-severity heartburn', 'efficacy and tolerability', 'efficacy and safety', 'adverse events', 'TSS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0030650', 'cui_str': 'Patents'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C2348127', 'cui_str': 'Sachet - unit of product usage'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0063146', 'cui_str': 'Hydroxyl Radical'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C2702414', 'cui_str': 'rice allergenic extract'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",20.0,0.204749,"No adverse events were reported.
","[{'ForeName': 'Davide Giuseppe', 'Initials': 'DG', 'LastName': 'Ribaldone', 'Affiliation': 'Department of Medical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Pendlimari', 'Initials': 'P', 'LastName': 'Rajesh', 'Affiliation': 'Rajalakshmi Hospital, Vidyaranyapura post.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Chandradhara', 'Affiliation': 'Bioagile Therapeutics Pvt. Ltd., Bangalore, India.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Astegiano', 'Affiliation': 'Unit of Gastroenterology Molinette and San Giovanni Antica Sede Hospitals, Città della Salute e della Scienza, Turin, Italy.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Pellicano', 'Affiliation': 'Unit of Gastroenterology Molinette and San Giovanni Antica Sede Hospitals, Città della Salute e della Scienza, Turin, Italy.'}]",European journal of gastroenterology & hepatology,['10.1097/MEG.0000000000001888']
2381,32804855,"Chromium picolinate balances the metabolic and clinical markers in nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled trial.","OBJECTIVE


Nonalcoholic fatty liver disease (NAFLD) is a complicated disease and is considered as a severe global health problem affecting 30% of adults worldwide. The present study aimed to evaluate changes in oxidative stress, adipokines, liver enzyme, and body composition following treatment with chromium picolinate (CrPic) among patients with NAFLD.
PARTICIPANTS AND METHODS


The current randomized, double-blind, placebo-controlled study was conducted on 46 NAFLD patients with the age range of 20-65 years. Patients were randomly classified into two groups, receiving either 400 µg CrPic tablets in two divided doses of 200 µg (23 patients) or placebo (23 patients) daily for 12 weeks. The participants' body composition and biochemical parameters were evaluated at the baseline and after 12 weeks.
RESULTS


Serum levels of liver enzymes reduced significantly only in the CrPic group (P < 0.05 for all), but not between the groups after the intervention. Besides, there were significant differences between the study groups regarding body weight and body fat mass, total antioxidant capacity, superoxide dismutase, malondialdehyde, leptin, and adiponectin post-intervention (P = 0.017, P = 0.032, P = 0.003, P = 0.023, P = 0.012, P = 0.003, and P = 0.042, respectively). However, glutathione peroxidase and resistin levels did not differ significantly between groups (P = 0.127 and P = 0.688, respectively).
DISCUSSION AND CONCLUSION


This study showed that consuming 400 µg/day of CrPic for 12 weeks in patients with NAFLD causes a significant change in leptin, adiponectin, oxidative stress (expect glutathione peroxidase), and body weight, compared to baseline. Nevertheless, it does not affect liver enzymes. Therefore, the CrPic supplementation may improve adipokines, some anthropometric indices, and oxidative stress in patients with NAFLD.",2020,"RESULTS


Serum levels of liver enzymes reduced significantly only in the CrPic group (P < 0.05 for all), but not between the groups after the intervention.","['46 NAFLD patients with the age range of 20-65\u2009years', 'patients with NAFLD', 'nonalcoholic fatty liver disease']","['Chromium picolinate balances', 'placebo', 'chromium picolinate (CrPic', 'CrPic supplementation', '400\u2009µg CrPic tablets']","['leptin, adiponectin, oxidative stress (expect glutathione peroxidase), and body weight', 'glutathione peroxidase and resistin levels', 'body weight and body fat mass, total antioxidant capacity, superoxide dismutase, malondialdehyde, leptin, and adiponectin post-intervention', 'oxidative stress, adipokines, liver enzyme, and body composition', 'Serum levels of liver enzymes']","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0163657', 'cui_str': 'CHROMIUM PICOLINATE'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0963992', 'cui_str': 'Resistin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",46.0,0.336329,"RESULTS


Serum levels of liver enzymes reduced significantly only in the CrPic group (P < 0.05 for all), but not between the groups after the intervention.","[{'ForeName': 'Fateme', 'Initials': 'F', 'LastName': 'Kooshki', 'Affiliation': 'Student Research Committee.'}, {'ForeName': 'Fardin', 'Initials': 'F', 'LastName': 'Moradi', 'Affiliation': 'Student Research Committee.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Karimi', 'Affiliation': 'Student Research Committee.'}, {'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Niazkar', 'Affiliation': 'Student Research Committee, Gonabad University of Medical Sciences, Gonabad.'}, {'ForeName': 'Manouchehr', 'Initials': 'M', 'LastName': 'Khoshbaten', 'Affiliation': 'Liver and Gastrointestinal Diseases Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Maleki', 'Affiliation': 'Student Research Committee.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Pourghassem Gargari', 'Affiliation': 'Nutrition Research Center, Department of Biochemistry & Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz.'}]",European journal of gastroenterology & hepatology,['10.1097/MEG.0000000000001830']
2382,32804869,Comparison of Iliac and Femoral Autograft Practices in Pemberton Pelvic Osteotomy.,"BACKGROUND


There is no consensus in regard to grafts used after pelvic osteotomy in developmental dysplasia of the hip in the literature. The aim of this study was to compare iliac and femoral autografts used after Pemberton pelvic osteotomy (PPO).
METHODS


In this prospective, randomized study, 60 hips with dysplasia of the hip were included. All patients underwent open reduction, PPO, and femoral shortening osteotomy. Iliac autograft (group I; n=30 hips; mean age, 39.07; range, 18 to 72 mo) and femoral autograft (group II; n=30 hips; mean age, 42.53; range, 19 to 70 mo) were used to fill the iliac osteotomy. The height and width of the iliac and femoral autografts were measured intraoperatively. Anteroposterior pelvic radiographs were obtained on the 45th day, and in the 2nd, 3rd, 6th, and 12th months postoperatively. Acetabular index angle, height of the graft, loss of graft position, graft resorption, operative time, blood loss, and union time were compared between the groups.
RESULTS


There was a significant difference in each group in terms of loss of graft height between the intraoperative measurement and the postoperative measurement at the 6th week and 3rd month. The intraoperative width of the grafts was significantly greater, loss of graft height was significantly less, and the amount of bleeding was significantly lower in group II (P<0.001 for all 3). However, time to union was significantly shorter in group I (P<0.001). There was no significant difference between the groups in terms of acetabular index angle at the last controls. There were loss of graft position in 2 cases and graft resorption in 1 case for group I, but no such cases occurred for group II.
CONCLUSIONS


Graft height and position loss, donor site morbidity, and graft resorption were less in the femoral autografts group compared with the iliac autografts group in the treatment PPO with femoral shortening osteotomy.
LEVEL OF EVIDENCE


Level II.",2020,There was a significant difference in each group in terms of loss of graft height between the intraoperative measurement and the postoperative measurement at the 6th week and 3rd month.,"['60 hips with dysplasia of the hip were included', 'Pemberton Pelvic Osteotomy', 'n=30 hips; mean age, 39.07; range, 18 to 72\u2009mo) and femoral autograft (group II; n=30 hips; mean age, 42.53; range, 19 to 70\u2009mo']","['Iliac and Femoral Autograft Practices', 'Iliac autograft', 'Pemberton pelvic osteotomy (PPO', 'iliac autografts']","['graft resorption', 'Anteroposterior pelvic radiographs', 'time to union', 'acetabular index angle', 'loss of graft position', 'Graft height and position loss, donor site morbidity, and graft resorption', 'intraoperative width of the grafts', 'height and width of the iliac and femoral autografts', 'amount of bleeding', 'loss of graft height', 'Acetabular index angle, height of the graft, loss of graft position, graft resorption, operative time, blood loss, and union time']","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0407472', 'cui_str': 'Pelvic osteotomy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0020889', 'cui_str': 'Bone structure of ilium'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0407472', 'cui_str': 'Pelvic osteotomy'}]","[{'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1444716', 'cui_str': 'Donor site'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0020889', 'cui_str': 'Bone structure of ilium'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}]",60.0,0.0333375,There was a significant difference in each group in terms of loss of graft height between the intraoperative measurement and the postoperative measurement at the 6th week and 3rd month.,"[{'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Bulut', 'Affiliation': 'Department of Orthopaedics and Traumatology, Elazig Medical Park Hospital.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Azboy', 'Affiliation': 'Department of Orthopaedics and Traumatology, Medipol University, School of Medicine.'}, {'ForeName': 'Emin', 'Initials': 'E', 'LastName': 'Ozkul', 'Affiliation': 'Department of Orthopaedics and Traumatology, Dicle University, School of Medicine, Diyarbakir, Turkey.'}, {'ForeName': 'Lokman', 'Initials': 'L', 'LastName': 'Karakurt', 'Affiliation': 'Department of Orthopaedics and Traumatology, Elazig Doğu Anadolu Hospital, Elaziğ.'}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001665']
2383,32804929,Cardiac and renal function interactions in heart failure with reduced ejection fraction: A mathematical modeling analysis.,"Congestive heart failure is characterized by suppressed cardiac output and arterial filling pressure, leading to renal retention of salt and water, contributing to further volume overload. Mathematical modeling provides a means to investigate the integrated function and dysfunction of heart and kidney in heart failure. This study updates our previously reported integrated model of cardiac and renal functions to account for the fluid exchange between the blood and interstitium across the capillary membrane, allowing the simulation of edema. A state of heart failure with reduced ejection fraction (HF-rEF) was then produced by altering cardiac parameters reflecting cardiac injury and cardiovascular disease, including heart contractility, myocyte hypertrophy, arterial stiffness, and systemic resistance. After matching baseline characteristics of the SOLVD clinical study, parameters governing rates of cardiac remodeling were calibrated to describe the progression of cardiac hemodynamic variables observed over one year in the placebo arm of the SOLVD clinical study. The model was then validated by reproducing improvements in cardiac function in the enalapril arm of SOLVD. The model was then applied to prospectively predict the response to the sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin, which has been shown to reduce heart failure events in HF-rEF patients in the recent DAPAHF clinical trial by incompletely understood mechanisms. The simulations predict that dapagliflozin slows cardiac remodeling by reducing preload on the heart, and relieves congestion by clearing interstitial fluid without excessively reducing blood volume. This provides a quantitative mechanistic explanation for the observed benefits of SGLT2i in HF-rEF. The model also provides a tool for further investigation of heart failure drug therapies.",2020,"The model was then applied to prospectively predict the response to the sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin, which has been shown to reduce heart failure events in HF-rEF patients in the recent DAPAHF clinical trial by incompletely understood mechanisms.","['heart failure with reduced ejection fraction', 'heart failure']","['reduced ejection fraction (HF-rEF', 'dapagliflozin', 'sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin']","['cardiac function', 'heart contractility, myocyte hypertrophy, arterial stiffness, and systemic resistance']","[{'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C1258017', 'cui_str': 'Heart Contractility'}, {'cui': 'C0596981', 'cui_str': 'Myocytes'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]",,0.0281883,"The model was then applied to prospectively predict the response to the sodium-glucose co-transporter 2 (SGLT2) inhibitor dapagliflozin, which has been shown to reduce heart failure events in HF-rEF patients in the recent DAPAHF clinical trial by incompletely understood mechanisms.","[{'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'School of Chemical, Materials, and Biomedical Engineering, University of Georgia, Athens, Georgia, United States of America.'}, {'ForeName': 'Sanchita', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'School of Chemical, Materials, and Biomedical Engineering, University of Georgia, Athens, Georgia, United States of America.'}, {'ForeName': 'K Melissa', 'Initials': 'KM', 'LastName': 'Hallow', 'Affiliation': 'School of Chemical, Materials, and Biomedical Engineering, University of Georgia, Athens, Georgia, United States of America.'}]",PLoS computational biology,['10.1371/journal.pcbi.1008074']
2384,32804950,Protection conferred by typhoid fever against recurrent typhoid fever in urban Kolkata.,"We evaluated the protection conferred by a first documented visit for clinical care of typhoid fever against recurrent typhoid fever prompting a visit. This study takes advantage of multi-year follow-up of a population with endemic typhoid participating in a cluster-randomized control trial of Vi capsular polysaccharide typhoid vaccine in Kolkata, India. A population of 70,566 individuals, of whom 37,673 were vaccinated with one dose of either Vi vaccine or a control (Hepatitis A) vaccine, were observed for four years. Surveillance detected 315 first typhoid visits, among whom 4 developed subsequent typhoid, 3 due to reinfection, defined using genomic criteria and corresponding to -124% (95% CI: -599, 28) protection by the initial illness. Point estimates of protection conferred by an initial illness were negative or negligible in both vaccinated and non-vaccinated subjects, though confidence intervals around the point estimates were wide. These data provide little support for a protective immunizing effect of clinically treated typhoid illness, though modest levels of protection cannot be excluded.",2020,"Point estimates of protection conferred by an initial illness were negative or negligible in both vaccinated and non-vaccinated subjects, though confidence intervals around the point estimates were wide.","['599', 'urban Kolkata', 'A population of 70,566 individuals, of whom 37,673 were vaccinated with one dose of either', 'population with endemic typhoid participating in a cluster-randomized control trial of Vi capsular polysaccharide typhoid vaccine in Kolkata, India']",['Vi vaccine or a control (Hepatitis A) vaccine'],[],"[{'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0243130', 'cui_str': 'endemics'}, {'cui': 'C0041466', 'cui_str': 'Typhoid fever'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205151', 'cui_str': 'Capsular'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0041469', 'cui_str': 'Typhoid vaccine'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019159', 'cui_str': 'Viral hepatitis, type A'}]",[],70566.0,0.430829,"Point estimates of protection conferred by an initial illness were negative or negligible in both vaccinated and non-vaccinated subjects, though confidence intervals around the point estimates were wide.","[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Im', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Md Taufiqul', 'Initials': 'MT', 'LastName': 'Islam', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Deok Ryun', 'Initials': 'DR', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Ahmmed', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chon', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Ashraful Islam', 'Initials': 'AI', 'LastName': 'Khan', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.'}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Sur', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, West Bengal, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Kanungo', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, West Bengal, India.'}, {'ForeName': 'Shanta', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, West Bengal, India.'}, {'ForeName': 'Sujit K', 'Initials': 'SK', 'LastName': 'Bhattacharya', 'Affiliation': 'National Institute of Cholera and Enteric Diseases, Kolkata, West Bengal, India.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Dougan', 'Affiliation': 'Department of Medicine, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Holt', 'Affiliation': 'Department of Infectious Diseases, Central Clinical School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Marks', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Clemens', 'Affiliation': 'International Centre for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008530']
2385,32805013,Efficacy of Yoga vs Cognitive Behavioral Therapy vs Stress Education for the Treatment of Generalized Anxiety Disorder: A Randomized Clinical Trial.,"Importance


Generalized anxiety disorder (GAD) is common, impairing, and undertreated. Although many patients with GAD seek complementary and alternative interventions, including yoga, data supporting yoga's efficacy or how it compares to first-line treatments are lacking.
Objectives


To assess whether yoga (Kundalini yoga) and cognitive behavioral therapy (CBT) for GAD are each more effective than a control condition (stress education) and whether yoga is noninferior to CBT for the treatment of GAD.
Design, Setting, and Participants


For this randomized, 3-arm, controlled, single-blind (masked independent raters) clinical trial, participants were recruited from 2 specialty academic centers starting December 1, 2013, with assessment ending October 25, 2019. Primary analyses, completed by February 12, 2020, included superiority testing of Kundalini yoga and CBT vs stress education and noninferiority testing of Kundalini yoga vs CBT.
Interventions


Participants were randomized to Kundalini yoga (n = 93), CBT for GAD (n = 90), or stress education (n = 43), which were each delivered to groups of 4 to 6 participants by 2 instructors during twelve 120-minute sessions with 20 minutes of daily homework.
Main Outcomes and Measures


The primary intention-to-treat outcome was acute GAD response (Clinical Global Impression-Improvement Scale score of much or very much improved) after 12 weeks as assessed by trained independent raters.
Results


Of 538 participants who provided consent and were evaluated, 226 (mean [SD] age, 33.4 [13.5] years; 158 [69.9%] female) with a primary diagnosis of GAD were included in the trial. A total of 155 participants (68.6%) completed the posttreatment assessment. Completion rates did not differ (Kundalini yoga, 60 [64.5%]; CBT, 67 [74.4%]; and stress education, 28 [65.1%]: χ2 = 2.39, df = 2, P = .30). Response rates were higher in the Kundalini yoga group (54.2%) than in the stress education group (33.%) (odds ratio [OR], 2.46 [95% CI, 1.12-5.42]; P = .03; number needed to treat, 4.59 [95% CI, 2.52-46.19]) and in the CBT group (70.8%) compared with the stress education group (33.0%) (OR, 5.00 [95% CI, 2.12-11.82]; P < .001; number needed to treat, 2.62 [95% CI, 1.91-5.68]). However, the noninferiority test did not find Kundalini yoga to be as effective as CBT (difference, 16.6%; P = .42 for noninferiority).
Conclusions and Relevance


In this trial, Kundalini yoga was efficacious for GAD, but the results support CBT remaining first-line treatment.
Trial Registration


ClinicalTrials.gov Identifier: NCT01912287.",2020,"Response rates were higher in the Kundalini yoga group (54.2%) than in the stress education group (33.%) (odds ratio [OR], 2.46 [95% CI, 1.12-5.42]; P = .03; number needed to treat, 4.59 [95% CI, 2.52-46.19]) and in the CBT group (70.8%) compared with the stress education group (33.0%) (","['participants were recruited from 2 specialty academic centers starting December 1, 2013, with assessment ending October 25, 2019', '538 participants who provided consent and were evaluated, 226 (mean [SD] age, 33.4 [13.5] years; 158 [69.9%] female) with a primary diagnosis of GAD were included in the trial', 'A total of 155 participants (68.6%) completed the posttreatment assessment', 'Generalized Anxiety Disorder']","['Kundalini yoga and CBT', 'Yoga vs Cognitive Behavioral Therapy vs Stress Education', 'CBT for GAD (n\u2009=\u200990), or stress education', 'Kundalini yoga', 'yoga (Kundalini yoga) and cognitive behavioral therapy (CBT']","['acute GAD response (Clinical Global Impression-Improvement Scale score of much or very much improved', 'Response rates', 'Completion rates']","[{'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517559', 'cui_str': '13.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442824', 'cui_str': 'Very'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",155.0,0.0966532,"Response rates were higher in the Kundalini yoga group (54.2%) than in the stress education group (33.%) (odds ratio [OR], 2.46 [95% CI, 1.12-5.42]; P = .03; number needed to treat, 4.59 [95% CI, 2.52-46.19]) and in the CBT group (70.8%) compared with the stress education group (33.0%) (","[{'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, New York University Grossman School of Medicine, New York, New York.'}, {'ForeName': 'Stefan G', 'Initials': 'SG', 'LastName': 'Hofmann', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, Boston, Massachusetts.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rosenfield', 'Affiliation': 'Department of Psychology, Southern Methodist University, Dallas, Texas.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Hoeppner', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hoge', 'Affiliation': 'Department of Psychiatry, Georgetown University Medical Center, Washington, DC.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bui', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Sat Bir S', 'Initials': 'SBS', 'LastName': 'Khalsa', 'Affiliation': ""Departments of Medicine and Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.2496']
2386,32805028,Avocado Consumption Alters Gastrointestinal Bacteria Abundance and Microbial Metabolite Concentrations among Adults with Overweight or Obesity: A Randomized Controlled Trial.,"BACKGROUND


Avocados are rich in dietary fiber and monounsaturated fatty acids (MUFAs), nutrients that have been independently connected to metabolic health benefits and the gastrointestinal microbiota.
OBJECTIVES


We aimed to evaluate the impact of avocado consumption on the gastrointestinal microbiota and microbial metabolites, secondary outcomes of the Persea americana for Total Health (PATH) study, and conduct exploratory analyses to assess relations between the fecal microbiota, fecal metabolites, and health markers.
METHODS


Adults [n = 163, 25-45 y, BMI (kg/m2) ≥ 25.0] were enrolled in the PATH study, a 12-wk investigator-blinded trial where participants were batch randomized to match the 2 groups by age, sex, visceral adiposity, and fasting glucose concentrations. Participants consumed isocaloric meals with or without avocado (175 g, men; 140 g, women) once daily for 12 wk. The fecal microbiota was assessed with 16S ribosomal RNA gene (V4 region) sequencing and analysis using DADA2 and QIIME2. Fecal fatty acid and bile acid concentrations were quantified using GC and LC-MS. Per-protocol (≥80% meal consumption) and intent-to-treat analyses were conducted using univariate ANOVA and Mann-Whitney U tests. Bivariate correlations were conducted between fecal microbiota, fecal metabolites, and health measures.
RESULTS


The avocado treatment increased ɑ diversity and enriched Faecalibacterium, Lachnospira, and Alistipes between 26% and 65% compared with the control group. The avocado group had 18% greater fecal acetate, 70% greater stearic acid, and 98% greater palmitic acid concentrations than the control group, while the concentrations of the bile acids cholic and chenodeoxycholic acid were 91% and 57% lower, respectively.
CONCLUSIONS


Daily avocado consumption resulted in lower fecal bile acid concentrations, greater fecal fatty acid and SCFAs, and greater relative abundances of bacteria capable of fiber fermentation, providing evidence that this nutrient-dense food affects digestive physiology, as well as the composition and metabolic functions of the intestinal microbiota. This trial was registered at www.clinicaltrials.gov as NCT02740439.",2020,"The avocado treatment increased ɑ diversity and enriched Faecalibacterium, Lachnospira, and Alistipes between 26% and 65% compared with the control group.","['163, 25-45 y, BMI (kg/m2', 'Adults with Overweight or Obesity', 'Adults [n\xa0']","['avocado consumption', 'Avocado Consumption', 'isocaloric meals with or without avocado']","['Gastrointestinal Bacteria Abundance and Microbial Metabolite Concentrations', 'Fecal fatty acid and bile acid concentrations', 'fecal bile acid concentrations, greater fecal fatty acid and SCFAs', 'fecal microbiota', 'fecal acetate', 'palmitic acid concentrations', 'fecal microbiota, fecal metabolites, and health measures', 'ɑ diversity and enriched Faecalibacterium, Lachnospira, and Alistipes', 'bile acids cholic and chenodeoxycholic acid', 'fecal microbiota, fecal metabolites, and health markers']","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0330230', 'cui_str': 'Avocado'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0030234', 'cui_str': 'Palmitic acid'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1229075', 'cui_str': 'Faecalibacterium'}, {'cui': 'C0317586', 'cui_str': 'Lachnospira'}, {'cui': 'C1490417', 'cui_str': 'Alistipes'}, {'cui': 'C0008024', 'cui_str': 'chenodeoxycholic acid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.176713,"The avocado treatment increased ɑ diversity and enriched Faecalibacterium, Lachnospira, and Alistipes between 26% and 65% compared with the control group.","[{'ForeName': 'Sharon V', 'Initials': 'SV', 'LastName': 'Thompson', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Melisa A', 'Initials': 'MA', 'LastName': 'Bailey', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Taylor', 'Affiliation': 'Department of Food Science and Human Nutrition, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Kaczmarek', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Annemarie R', 'Initials': 'AR', 'LastName': 'Mysonhimer', 'Affiliation': 'Department of Food Science and Human Nutrition, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Caitlyn G', 'Initials': 'CG', 'LastName': 'Edwards', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Ginger E', 'Initials': 'GE', 'LastName': 'Reeser', 'Affiliation': 'Department of Kinesiology and Community Health, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Burd', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Naiman A', 'Initials': 'NA', 'LastName': 'Khan', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL, USA.'}, {'ForeName': 'Hannah D', 'Initials': 'HD', 'LastName': 'Holscher', 'Affiliation': 'Division of Nutritional Sciences, University of Illinois, Urbana-Champaign, IL, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa219']
2387,30974489,Influence of smoking on CYP2C19 genetic variants and clopidogrel efficacy in patients with minor stroke or transient ischaemic attack.,"BACKGROUND AND PURPOSE


Studies suggest that smoking affects clopidogrel efficacy. However, whether it influences the association between CYP2C19 genetic variants and clopidogrel efficacy is not clear.
METHODS


In total, 2961 patients from the CHANCE trial were involved in this substudy and were successfully genotyped for two single-nucleotide polymorphisms of CYP2C19 (*2 and *3). The Cox proportional risk regression model was used to evaluate the interactions between CYP2C19*2 and CYP2C19*3 carrier status and clopidogrel efficacy stratified by smoking status.
RESULTS


There were marginal significant interactions between CYP2C19*2 and CYP2C19*3 allele carrier status and antiplatelet treatment regimen for the risk of recurrent stroke and composite events (P = 0.054, P = 0.051, respectively) amongst smokers, but not in non-smokers. Amongst smokers, clopidogrel plus aspirin decreased the recurrence rate of stroke compared with aspirin alone in non-carriers (3.8% vs. 11.8%, hazard ratio 0.32, 95% confidence interval 0.15-0.65, P = 0.002), but not in carriers. Similar results were also found for the recurrence rate of composite events in smokers. No significant difference was found for hemorrhage events in any group.
CONCLUSIONS


Amongst patients with minor stroke or transient ischaemic attack, marginal significant interactions between CYP2C19*2 and CYP2C19*3 allele carrier status and clopidogrel efficacy were found in smokers but not in non-smokers. Amongst smokers, clopidogrel plus aspirin might decrease the recurrence rate of stroke in non-carriers of *2 and *3 alleles of CYP2C19 compared with aspirin alone. However, caution should be taken to interpret our findings in view of several limitations in our study.",2019,"Amongst smokers, clopidogrel plus aspirin might decrease the recurrence rate of stroke in non-carriers of *2 and *3 alleles of CYP2C19 compared with aspirin alone.","['2961 patients from the CHANCE trial', 'patients with minor stroke or transient ischaemic attack']","['clopidogrel plus aspirin', 'aspirin', 'CYP2C19']","['risk of recurrent stroke and composite events', 'recurrence rate of stroke', '3 allele carrier status and clopidogrel efficacy', 'recurrence rate of composite events', 'hemorrhage events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0002085', 'cui_str': 'Genetic alleles'}, {'cui': 'C0449439', 'cui_str': 'Carrier status'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",2961.0,0.0207898,"Amongst smokers, clopidogrel plus aspirin might decrease the recurrence rate of stroke in non-carriers of *2 and *3 alleles of CYP2C19 compared with aspirin alone.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Anand', 'Affiliation': 'Department of Neurosurgery, Wayne State University School of Medicine, Detroit, MI, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'INI Stroke Network, OSF Healthcare System, University of Illinois College of Medicine, Peoria, IL, USA.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': 'Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of neurology,['10.1111/ene.13962']
2388,31092727,Self-tolerance curtails the B cell repertoire to microbial epitopes.,"Immunological tolerance removes or inactivates self-reactive B cells, including those that also recognize cross-reactive foreign antigens. Whereas a few microbial pathogens exploit these ""holes"" in the B cell repertoire by mimicking host antigens to evade immune surveillance, the extent to which tolerance reduces the B cell repertoire to foreign antigens is unknown. Here, we use single-cell cultures to determine the repertoires of human B cell antigen receptors (BCRs) before (transitional B cells) and after (mature B cells) the second B cell tolerance checkpoint in both healthy donors and in patients with systemic lupus erythematosus (SLE) . In healthy donors, the majority (~70%) of transitional B cells that recognize foreign antigens also bind human self-antigens (foreign+self), and peripheral tolerance halves the frequency of foreign+self-reactive mature B cells. In contrast, in SLE patients who are defective in the second tolerance checkpoint, frequencies of foreign+self-reactive B cells remain unchanged during maturation of transitional to mature B cells. Patterns of foreign+self-reactivity among mature B cells from healthy donors differ from those of SLE patients. We propose that immune tolerance significantly reduces the scope of the BCR repertoire to microbial pathogens and that cross-reactivity between foreign and self epitopes may be more common than previously appreciated.",2019,"Immunological tolerance removes or inactivates self-reactive B cells, including those that also recognize cross-reactive foreign antigens.","['healthy donors differ from those of SLE patients', 'healthy donors and in patients with systemic lupus erythematosus (SLE) ']",[],[],"[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],[],,0.0183529,"Immunological tolerance removes or inactivates self-reactive B cells, including those that also recognize cross-reactive foreign antigens.","[{'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Watanabe', 'Affiliation': 'Department of Immunology, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Kuei-Ying', 'Initials': 'KY', 'LastName': 'Su', 'Affiliation': 'Department of Immunology, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kuraoka', 'Affiliation': 'Department of Immunology, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Yang', 'Affiliation': 'Department of Immunology, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Alexander E', 'Initials': 'AE', 'LastName': 'Reynolds', 'Affiliation': 'Department of Immunology, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Aaron G', 'Initials': 'AG', 'LastName': 'Schmidt', 'Affiliation': ""Deparment of Microbiology, Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Harrison', 'Affiliation': ""Laboratory of Molecular Medicine, Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Barton F', 'Initials': 'BF', 'LastName': 'Haynes', 'Affiliation': 'Department of Immunology, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'E William', 'Initials': 'EW', 'LastName': 'St Clair', 'Affiliation': 'Department of Immunology, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Garnett', 'Initials': 'G', 'LastName': 'Kelsoe', 'Affiliation': 'Department of Immunology, Duke University School of Medicine, Durham, North Carolina, USA.'}]",JCI insight,['10.1172/jci.insight.122551']
2389,31161927,Skin Transcriptome of Middle-Aged Women Supplemented With Natural Herbo-mineral Shilajit Shows Induction of Microvascular and Extracellular Matrix Mechanisms.,"Objective:  Shilajit is a pale-brown to blackish-brown organic mineral substance available from Himalayan rocks. We demonstrated that in type I obese humans, shilajit supplementation significantly upregulated extracellular matrix (ECM)-related genes in the skeletal muscle. Such an effect was highly synergistic with exercise. The present study (clinicaltrials.gov NCT02762032) aimed to evaluate the effects of shilajit supplementation on skin gene expression profile and microperfusion in healthy adult females.  Methods:  The study design comprised six total study visits including a baseline visit (V1) and a final 14-week visit (V6) following oral shilajit supplementation (125 or 250 mg bid). A skin biopsy of the left inner upper arm of each subject was collected at visit 2 and visit 6 for gene expression profiling using Affymetrix Clariom™ D Assay. Skin perfusion was determined by MATLAB processing of dermascopic images. Transcriptome data were normalized and subjected to statistical analysis. The differentially regulated genes were subjected to Ingenuity Pathway Analysis (IPA ® ). The expression of the differentially regulated genes identified by IPA ®  were verified using real-time polymerase chain reaction (RT-PCR).  Results:  Supplementation with shilajit for 14 weeks was not associated with any reported adverse effect within this period. At a higher dose (250 mg bid), shilajit improved skin perfusion when compared to baseline or the placebo. Pathway analysis identified shilajit-inducible genes relevant to endothelial cell migration, growth of blood vessels, and ECM which were validated by quantitative real-time polymerase chain reaction (RT-PCR) analysis.  Conclusions:  This work provides maiden evidence demonstrating that oral shilajit supplementation in adult healthy women induced genes relevant to endothelial cell migration and growth of blood vessels. Shilajit supplementation improved skin microperfusion.",2019,"At a higher dose (250 mg bid), shilajit improved skin perfusion when compared to baseline or the placebo.","['adult healthy women', 'six total study visits including a baseline visit (V1) and a final 14-week visit (V6) following', 'healthy adult females', 'Skin Transcriptome of Middle-Aged Women Supplemented With']","['shilajit supplementation', 'Shilajit supplementation', 'oral shilajit supplementation', 'Natural Herbo-mineral Shilajit', 'placebo']","['skin gene expression profile and microperfusion', 'endothelial cell migration and growth of blood vessels', 'Skin perfusion', 'shilajit improved skin perfusion', 'skin microperfusion', 'adverse effect']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C3178810', 'cui_str': 'Transcriptomes'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0066936', 'cui_str': 'mumie'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1449575', 'cui_str': 'Microarray Analysis'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0066936', 'cui_str': 'mumie'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0923222,"At a higher dose (250 mg bid), shilajit improved skin perfusion when compared to baseline or the placebo.","[{'ForeName': 'Amitava', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'a Department of Surgery, Indiana Center for Regenerative Medicine and Engineering, Indiana University School of Medicine , Indianapolis , IN.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'S El Masry', 'Affiliation': 'a Department of Surgery, Indiana Center for Regenerative Medicine and Engineering, Indiana University School of Medicine , Indianapolis , IN.'}, {'ForeName': 'Surya C', 'Initials': 'SC', 'LastName': 'Gnyawali', 'Affiliation': 'b Department of Surgery, The Ohio State University, Wexner Medical Center , Columbus , Ohio.'}, {'ForeName': 'Subhadip', 'Initials': 'S', 'LastName': 'Ghatak', 'Affiliation': 'b Department of Surgery, The Ohio State University, Wexner Medical Center , Columbus , Ohio.'}, {'ForeName': 'Kanhaiya', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'a Department of Surgery, Indiana Center for Regenerative Medicine and Engineering, Indiana University School of Medicine , Indianapolis , IN.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stewart', 'Affiliation': 'b Department of Surgery, The Ohio State University, Wexner Medical Center , Columbus , Ohio.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'b Department of Surgery, The Ohio State University, Wexner Medical Center , Columbus , Ohio.'}, {'ForeName': 'Abhijoy', 'Initials': 'A', 'LastName': 'Saha', 'Affiliation': 'e Department of Statistics, The Ohio State University , Columbus , OH , USA.'}, {'ForeName': 'Gayle', 'Initials': 'G', 'LastName': 'Gordillo', 'Affiliation': 'd Department of Plastic Surgery, Indiana University School of Medicine , Indianapolis , IN.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Khanna', 'Affiliation': 'b Department of Surgery, The Ohio State University, Wexner Medical Center , Columbus , Ohio.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2018.1564088']
2390,31292932,"Individual and combined effects of a cognitive task, light finger touch, and vision on standing balance in older adults with mild cognitive impairment.","BACKGROUND


Postural instability and balance dysfunction have been identified in older adults with mild cognitive impairment (MCI). Performing a secondary task while standing can additionally jeopardize their balance.
AIMS


The purpose of the exploratory study was to investigate the individual and combined effects of a cognitive task, light finger touch and vision on postural sway in older adults with MCI as compared to healthy older adults.
METHODS


Five individuals with MCI and ten age-matched control subjects stood on the force platform with and without the performance of a cognitive task (counting backward from a randomly chosen three-digit number), with and without light finger touch contact applied to an external stable structure, and with eyes open or closed. The center of pressure (COP) excursion, range, velocity in antero-posterior and medial-lateral directions and sway area were calculated.
RESULTS


Participants demonstrated significantly larger postural sway when vision was not available (p < 0.05), smaller postural sway when using a finger touch contact (p < 0.05) and increased postural sway during the performance of the cognitive task (p < 0.05). When finger touch and a cognitive task were performed simultaneously, body sway decreased as compared to just standing in healthy older adults but not in individuals with MCI (p < 0.05).
CONCLUSIONS


The results help to better understand the individual and combined effects of vision, light touch and a cognitive task in postural control of individuals with MCI. The study outcome also provides a basis for future studies of balance control in patients with cognitive impairments.",2020,"RESULTS


Participants demonstrated significantly larger postural sway when vision was not available (p < 0.05), smaller postural sway when using a finger touch contact (p < 0.05) and increased postural sway during the performance of the cognitive task (p < 0.05).","['Five individuals with MCI and ten age-matched control subjects stood on the', 'older adults with mild cognitive impairment', 'individuals with MCI', 'healthy older adults', 'older adults with', 'older adults with mild cognitive impairment (MCI', 'patients with cognitive impairments']","['cognitive task, light finger touch and vision', 'force platform with and without the performance of a cognitive task (counting backward from a randomly chosen three-digit number), with and without light finger touch contact applied to an external stable structure, and with eyes open or closed', 'MCI', 'cognitive task, light finger touch, and vision']","['center of pressure (COP) excursion, range, velocity in antero-posterior and medial-lateral directions and sway area', 'larger postural sway', 'smaller postural sway', 'postural sway']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]",5.0,0.0130657,"RESULTS


Participants demonstrated significantly larger postural sway when vision was not available (p < 0.05), smaller postural sway when using a finger touch contact (p < 0.05) and increased postural sway during the performance of the cognitive task (p < 0.05).","[{'ForeName': 'Nikita', 'Initials': 'N', 'LastName': 'Goyal', 'Affiliation': 'Department of Physical Therapy (MC 898), University of Illinois at Chicago, 1919\xa0W. Taylor Street, Chicago, IL, 60612, USA.'}, {'ForeName': 'Yunju', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'School of Engineering and Department of Physical Therapy, Grand Valley State University, Grand Rapids, MI, USA.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Luna', 'Affiliation': 'Department of Medicine, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Alexander S', 'Initials': 'AS', 'LastName': 'Aruin', 'Affiliation': 'Department of Physical Therapy (MC 898), University of Illinois at Chicago, 1919\xa0W. Taylor Street, Chicago, IL, 60612, USA. aaruin@uic.edu.'}]",Aging clinical and experimental research,['10.1007/s40520-019-01262-y']
2391,31300571,Patient-Defined Visit Priorities in Primary Care: Psychosocial Versus Medically-Related Concerns.,"BACKGROUND


Primary care providers (PCPs) are often challenged to address multiple patient concerns during time-limited visits. The need for PCPs to limit the number of issues addressed may have a negative impact on discussion of patient-defined visit priorities.
METHODS


Using data from a recent clinical trial (Aligning Patients and Providers, ClinicalTrials.gov: NCT02707146), we examined the association between patient-defined visit priorities and subsequent provider actions taken during and after the visit. We tested the hypothesis that psychosocial concerns (eg, stress, anxiety, caregiving demands) are less likely to be addressed than traditional medical concerns.
RESULTS


We analyzed 147 patient-defined visit priorities submitted just before the visit by 109 patients (mean age, 59.0 ± 12.7 years; including 73.4% women, 47.7% non-White race/ethnicity). Nearly one quarter of patient-defined visit priorities were related to psychosocial concerns (35/147; 23.8%). In models adjusting for age, gender, race/ethnicity, and familiarity with PCP, patients' psychosocial priorities were significantly less likely than medical priorities to be addressed during the visit (63% vs. 88%; adjusted odds ratio [aOR], 0.16; 95% CI, 0.06 to 0.41;  P  < .001), to receive clinical action (51% vs. 82%; aOR, 0.15; 95% CI, 0.06 to 0.38;  P  < .001), or to receive post visit information from the primary care doctor (17% vs. 32%; aOR, 0.39; 95% CI, 0.14 to 1.08;  P  = .07).
CONCLUSIONS


Patient-defined psychosocial priorities are less likely to be addressed during (or immediately after) primary care visits compared with patient-defined medical priorities.",2019,Nearly one quarter of patient-defined visit priorities were related to psychosocial concerns (35/147; 23.8%).,"['147 patient-defined visit priorities submitted just before the visit by 109 patients (mean age, 59.0 ± 12.7 years; including 73.4% women, 47.7% non-White race/ethnicity']",[],['clinical action'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439607', 'cui_str': 'Priorities'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}]",[],"[{'cui': 'C0441472', 'cui_str': 'Action'}]",,0.0292209,Nearly one quarter of patient-defined visit priorities were related to psychosocial concerns (35/147; 23.8%).,"[{'ForeName': 'Eilann Clare', 'Initials': 'EC', 'LastName': 'Santo', 'Affiliation': 'From the Department of Internal Medicine(ECS), Division of Research (MTV, CSU, RWG), Kaiser Permanente Northern California, Oakland, CA.'}, {'ForeName': 'Michelle TuongVi', 'Initials': 'MT', 'LastName': 'Vo', 'Affiliation': 'From the Department of Internal Medicine(ECS), Division of Research (MTV, CSU, RWG), Kaiser Permanente Northern California, Oakland, CA.'}, {'ForeName': 'Connie S', 'Initials': 'CS', 'LastName': 'Uratsu', 'Affiliation': 'From the Department of Internal Medicine(ECS), Division of Research (MTV, CSU, RWG), Kaiser Permanente Northern California, Oakland, CA.'}, {'ForeName': 'Richard William', 'Initials': 'RW', 'LastName': 'Grant', 'Affiliation': 'From the Department of Internal Medicine(ECS), Division of Research (MTV, CSU, RWG), Kaiser Permanente Northern California, Oakland, CA. Richard.W.Grant@kp.org.'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2019.04.180380']
2392,32805205,"Lubiprostone in patients with non-alcoholic fatty liver disease: a randomised, double-blind, placebo-controlled, phase 2a trial.","BACKGROUND


The laxative drug lubiprostone improves intestinal permeability in healthy volunteers. We aimed to assess efficacy and safety of lubiprostone in patients with non-alcoholic fatty liver disease (NAFLD) with constipation via attenuation of intestinal permeability.
METHODS


This randomised, double-blind, placebo-controlled, phase 2a study in Yokohama City University Hospital, Japan, recruited patients (aged 20-85 years) with NAFLD and constipation, alanine aminotransferase (ALT) at least 40 U/L, liver stiffness (≤6·7 kPa), and hepatic fat fraction at least 5·2% when assessed by MRI-proton density fat fraction. Eligible patients were randomly assigned (11:10:9) by a computer-based system and stratified by age and sex to receive 24 μg lubiprostone, 12 μg lubiprostone, or placebo, orally, once per day for 12 weeks. The primary endpoint was the absolute changes in ALT at 12 weeks. Efficacy analysis was done by intention to treat. Safety was assessed in all treated patients. This trial was registered with University Hospital Medical Information Network Clinical Trials Registry (UMIN000026635).
FINDINGS


Between March 24, 2017, and April 3, 2018, we screened 288 patients, of whom 150 (52%) were randomly assigned to treatment: 55 patients were assigned to receive 24 μg lubiprostone, 50 to receive 12 μg lubiprostone, and 45 to receive placebo. A greater decrease in the absolute ALT levels from baseline to 12 weeks was seen in the 24 μg lubiprostone group (mean -13 U/L [SD 19]) than in the placebo group (1 U/L [24]; mean difference -15 U/L [95% CI -23 to -6], p=0·0007) and in the 12 μg lubiprostone group (-12 U/L [21]) than in the placebo group (mean difference -13 U/L [-22 to -5], p=0·0023). 18 (33%) of 55 patients in the 24 μg group had at least one adverse event, as did three (6%) of 47 patients in the 12 μg group and three (7%) of 43 in the placebo group. The most common adverse event was diarrhoea (17 [31%] of patients in the 24 μg group, three [6%] in the 12 μg group, none in the placebo group). No life-threatening events or treatment-related deaths occurred.
INTERPRETATION


Lubiprostone was well tolerated and reduced the levels of liver enzymes in patients with NAFLD and constipation. Further studies are necessary to better define the efficacy and tolerability of lubiprostone in patients with NAFLD without constipation.
FUNDING


Mylan EPD G.K.",2020,"No life-threatening events or treatment-related deaths occurred.
","['288 patients, of whom 150 (52%) were randomly assigned to treatment: 55 patients', 'healthy volunteers', 'patients with NAFLD without constipation', 'Yokohama City University Hospital, Japan, recruited patients (aged 20-85 years) with NAFLD and constipation, alanine aminotransferase (ALT', 'patients with non-alcoholic fatty liver disease', 'patients with non-alcoholic fatty liver disease (NAFLD) with constipation via attenuation of intestinal permeability', 'Between March 24, 2017, and April 3, 2018', 'patients with NAFLD and constipation', 'Eligible patients']","['computer-based system and stratified by age and sex to receive 24 μg lubiprostone, 12 μg lubiprostone, or placebo', 'U/L', 'Lubiprostone', 'laxative drug lubiprostone', '24 μg lubiprostone, 50 to receive 12 μg lubiprostone, and 45 to receive placebo', 'lubiprostone', 'placebo']","['absolute ALT levels', 'Safety', 'intestinal permeability', 'diarrhoea', 'adverse event', 'efficacy and tolerability', 'efficacy and safety', 'absolute changes in ALT', 'levels of liver enzymes', 'liver stiffness (≤6·7 kPa), and hepatic fat fraction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1684405', 'cui_str': 'lubiprostone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439339', 'cui_str': 'mU/mL'}, {'cui': 'C0282090', 'cui_str': 'Laxative'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0263428', 'cui_str': 'Ulerythema ophryogenes'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}]",55.0,0.708799,"No life-threatening events or treatment-related deaths occurred.
","[{'ForeName': 'Takaomi', 'Initials': 'T', 'LastName': 'Kessoku', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Palliative Medicine, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Kento', 'Initials': 'K', 'LastName': 'Imajo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ozaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Iwaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Honda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Palliative Medicine, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Gastroenterology, International University of Health and Welfare Atami Hospital, Atami, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Wataru', 'Initials': 'W', 'LastName': 'Tomeno', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Gastroenterology, International University of Health and Welfare Atami Hospital, Atami, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Kato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Higurashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Yoneda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kirikoshi', 'Affiliation': 'Clinical Laboratory Department, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Kazumi', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Taguri', 'Affiliation': 'Department of Data Science, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Haruki', 'Initials': 'H', 'LastName': 'Usuda', 'Affiliation': 'Department of Pharmacology, Shimane University Faculty of Medicine, Izumo, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Wada', 'Affiliation': 'Department of Pharmacology, Shimane University Faculty of Medicine, Izumo, Japan.'}, {'ForeName': 'Noritoshi', 'Initials': 'N', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan; Department of Oncology, Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan. Electronic address: nakajima-tky@umin.ac.jp.'}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30216-8']
2393,32805259,Neonatal Abstinence Syndrome Severity Index Predicts 18 Month Neurodevelopmental Outcome in Neonates Randomized to Morphine or Methadone.,"OBJECTIVE


To develop an index to determine which opioid exposed neonates have the most severe Neonatal Abstinence Syndrome (NAS).
STUDY DESIGN


Full-term neonates with NAS (n=116) from mothers maintained on methadone or buprenorphine were enrolled from 8 sites into a randomized clinical trial of morphine vs methadone. Ninety-nine (85%) were evaluated at hospital discharge using the NICU Network Neurobehavioral Scale (NNNS). At 18-months, 83 of 99 (83.8%) were evaluated with the Bayley Scales of Infant and Toddler Development-Third Edition (Bayley-III) and 77 of 99 (77.7%) with the Child Behavior Checklist (CBCL).
RESULTS


Cluster analysis was used to define high (n=21) and low (n=77) NAS severity. Infants in the high NAS severity cluster had a longer length of stay (P<.001), longer length of stay due to NAS (P < .001), longer length of treatment due to NAS (P<.001), higher total dose of study drug (P<.001), were more likely to have received phenobarbital (P<.001), be treated with morphine (P=.020) and have an atypical NNNS profile (P=.005) than infants in the low NAS severity group. The groups did not differ on maximum Finnegan score. At 18 months, in unadjusted analyses the low severity cluster had higher scores on the Bayley-III Cognitive (P=.013), Language (P<.001) and Motor (P=.041) Composites and less total behavior problems on the CBCL than the high severity cluster (P=.028). In adjusted analyses, the difference remained for Language Composite (P=.013).
CONCLUSIONS


Presumptive measures of NAS severity can be aggregated to develop an index that predicts developmental outcomes at 18 months of age.",2020,"Infants in the high NAS severity cluster had a longer length of stay (P<.001), longer length of stay due to NAS (P < .001), longer length of treatment due to NAS (P<.001), higher total dose of study drug (P<.001), were more likely to have received phenobarbital (P<.001), be treated with morphine (P=.020) and have an atypical NNNS profile (P=.005) than infants in the low NAS severity group.",['Full-term neonates with NAS (n=116) from mothers maintained on'],"['morphine vs methadone', 'Morphine or Methadone', 'morphine', 'methadone or buprenorphine']","['longer length of treatment due to NAS', 'Neonatal Abstinence Syndrome Severity Index Predicts', 'maximum Finnegan score', 'Bayley-III Cognitive (P=.013), Language (P<.001) and Motor (P=.041) Composites and less total behavior problems', 'Bayley Scales of Infant and Toddler Development-Third Edition', 'longer length of stay', 'Language Composite', 'hospital discharge using the NICU Network Neurobehavioral Scale (NNNS', 'Child Behavior Checklist (CBCL', 'longer length of stay due to NAS']","[{'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Abstinence Syndrome'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Abstinence Syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0441796', 'cui_str': 'Third edition'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",,0.126136,"Infants in the high NAS severity cluster had a longer length of stay (P<.001), longer length of stay due to NAS (P < .001), longer length of treatment due to NAS (P<.001), higher total dose of study drug (P<.001), were more likely to have received phenobarbital (P<.001), be treated with morphine (P=.020) and have an atypical NNNS profile (P=.005) than infants in the low NAS severity group.","[{'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Flannery', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI, United States.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Davis', 'Affiliation': 'Department of Pediatrics, The Floating Hospital for Children at Tufts Medical Center, Boston, MA; Tufts Clinical and Translational Science Institute, Boston, MA; The Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Czynski', 'Affiliation': 'Department of Pediatrics, Warren Alpert Medical School of Brown University and Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Dansereau', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI, United States.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Oliveira', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI, United States.'}, {'ForeName': 'Samantha A', 'Initials': 'SA', 'LastName': 'Camardo', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI, United States.'}, {'ForeName': 'Barry M', 'Initials': 'BM', 'LastName': 'Lester', 'Affiliation': 'Brown Center for the Study of Children at Risk and Women and Infants Hospital, Providence, RI, United States; Department of Pediatrics, Warren Alpert Medical School of Brown University and Women and Infants Hospital, Providence, RI; Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI. Electronic address: Barry_Lester@Brown.edu.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.08.034']
2394,32805363,Effects of epidural anesthesia on quality of life in elderly patients undergoing esophagectomy.,"Continuous epidural analgesia during surgery can effectively inhibit surgically induced stress and inflammatory response. It also spares opioid use and reduces postoperative pain. This study explored the effects of intraoperative epidural anesthesia on quality of life and central nervous system injury in elderly patients after esophagectomy. Elderly patients who were scheduled for thoracoscopic-laparoscopic esophagectomy were eligible for this randomized controlled study. The patients in the experimental group received general anesthesia combined with epidural anesthesia, while the patients in the control group received only general anesthesia. At the end of surgery, all patients received the same epidural analgesia program before extubation. Health-related quality of life (HRQoL) were assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of life Quetionnaires (QLQ)-C30 and QLQ-OES18 questionnaires. Two HRQoL questionnaires were filled out before surgery, on day 7 and after the third month postoperatively. The Montreal Cognitive Assessment (MOCA) and serum S100β level were also evaluated at baseline and on postoperative day 7. Compared with the group without intraoperative epidural anesthesia, the epidural anesthesia group had better quality of life scores particularly in the social, emotional and global health domains. The symptoms of nausea, constipation, sleep disorders, dysphagia, reflux, pain, and cough difficulty were less severe. In addition, the S100βcontent of peripheral blood was also lower on postoperative day 7 (1199.8 pg/ml vs 1341.2 pg/ml, P<0.001). There was no significant difference in MOCA scores between the two groups. Intraoperative epidural anesthesia may improve the quality of life after esophagectomy in elderly patients, and reduce the neuroinflammatory response, compared with the patients receiving general anesthesia only. Clinical trial registration: Chinese Clinical Trial Registry Identifier (ChiCTR1800014828).",2020,"Compared with the group without intraoperative epidural anesthesia, the epidural anesthesia group had better quality of life scores particularly in the social, emotional and global health domains.","['elderly patients undergoing esophagectomy', 'elderly patients', 'Elderly patients who were scheduled for', 'elderly patients after esophagectomy']","['thoracoscopic-laparoscopic esophagectomy', 'Intraoperative epidural anesthesia', 'general anesthesia combined with epidural anesthesia', 'control group received only general anesthesia', 'intraoperative epidural anesthesia', 'epidural anesthesia']","['quality of life', 'MOCA scores', 'Montreal Cognitive Assessment (MOCA) and serum S100β level', 'symptoms of nausea, constipation, sleep disorders, dysphagia, reflux, pain, and cough difficulty', 'postoperative pain', 'quality of life and central nervous system injury', 'Quality of life Quetionnaires (QLQ)-C30 and QLQ-OES18 questionnaires', 'quality of life scores', 'Health-related quality of life (HRQoL', 'European Organisation for Research and Treatment of Cancer (EORTC', 'S100βcontent of peripheral blood']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0002913', 'cui_str': 'Epidural anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C1264238', 'cui_str': 'Injury of central nervous system'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}]",,0.0666137,"Compared with the group without intraoperative epidural anesthesia, the epidural anesthesia group had better quality of life scores particularly in the social, emotional and global health domains.","[{'ForeName': 'Xiaoyu', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230022, China P.R.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230022, China P.R.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Fang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230022, China P.R.'}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Fang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230022, China P.R.'}, {'ForeName': 'Gordon Tin Chun', 'Initials': 'GTC', 'LastName': 'Wong', 'Affiliation': 'Department of Anesthesiology, The University of Hong Kong, Hong Kong S.A.R, China P.R.'}, {'ForeName': 'Xuesheng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of Anhui Medical University, Hefei, 230022, China P.R.. Electronic address: liuxuesheng@ahmu.edu.cn.'}]",Seminars in thoracic and cardiovascular surgery,['10.1053/j.semtcvs.2020.08.001']
2395,32805428,Comparing the prophylactic action of lipid and non-lipid containing tear supplements in adverse environmental conditions: A randomised crossover trial.,"PURPOSE


To evaluate the prophylactic benefits of lipid-based and non-lipid-based artificial tear lubricants, in dry eye disease, after adverse environmental exposure.
METHODS


Twenty-eight participants with dry eye disease were recruited in a prospective, double-masked, randomised crossover trial. On separate days, participants were randomised to receive a single application of a lipid-containing tear supplement (Systane® Complete) to one eye, and a non-lipid containing eye drop (Systane® Ultra) to the contralateral eye. Participants were then exposed to a previously validated simulated adverse environment. Symptoms, non-invasive tear film break-up time, lipid layer grade, and tear meniscus height were assessed at three time points; baseline, following eye drop instillation, and after exposure to the adverse environment.
RESULTS


Both treatments effected improvements in symptoms and non-invasive tear film stability following instillation (all p < 0.05), although an improvement in lipid layer quality was limited to the lipid-containing tear supplement (p = 0.003). Although protective effects were conferred by both treatments following exposure to the simulated adverse environment, more favourable symptomology scores, non-invasive tear film stability, and lipid layer quality were observed in the lipid-containing tear supplement group (all p < 0.05). No significant changes were observed in tear meniscus height in both treatment groups (all p > 0.05).
CONCLUSIONS


Both lipid and non-lipid based artificial tear supplement demonstrated prophylactic benefits against a simulated adverse environment. However, the ability to preserve tear film quality and reduce dry eye symptomology was greater with the lipid-containing eye drop.
TRIAL REGISTRATION NUMBER


ACTRN12619000361101.",2020,"Both treatments effected improvements in symptoms and non-invasive tear film stability following instillation (all p < 0.05), although an improvement in lipid layer quality was limited to the lipid-containing tear supplement (p = 0.003).","['Twenty-eight participants with dry eye disease', 'adverse environmental conditions']","['lipid-containing tear supplement (Systane® Complete) to one eye, and a non-lipid containing eye drop (Systane® Ultra) to the contralateral eye', 'lipid-based and non-lipid-based artificial tear lubricants', 'lipid and non-lipid containing tear supplements']","['lipid layer quality', 'symptoms and non-invasive tear film stability', 'favourable symptomology scores, non-invasive tear film stability, and lipid layer quality', 'tear meniscus height', 'Symptoms, non-invasive tear film break-up time, lipid layer grade, and tear meniscus height', 'tear film quality and reduce dry eye symptomology']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1655274', 'cui_str': 'Systane'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0282222', 'cui_str': 'Lubricant'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height'}, {'cui': 'C0429495', 'cui_str': 'Tear film break-up time'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}]",28.0,0.0859293,"Both treatments effected improvements in symptoms and non-invasive tear film stability following instillation (all p < 0.05), although an improvement in lipid layer quality was limited to the lipid-containing tear supplement (p = 0.003).","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Muntz', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Marasini', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Michael T M', 'Initials': 'MTM', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand.'}, {'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Craig', 'Affiliation': 'Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, New Zealand. Electronic address: jp.craig@auckland.ac.nz.'}]",The ocular surface,['10.1016/j.jtos.2020.08.004']
2396,32805434,Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial.,"INTRODUCTION


Although as many as 75% of the >2 million annual intensive care unit (ICU) survivors experience symptoms of psychological distress that persist for months to years, few therapies exist that target their symptoms and accommodate their unique needs. In response, we developed LIFT, a mobile app-based mindfulness intervention. LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1).
OBJECTIVE


To describe the methods of a factorial experimental clinical trial (LIFT2) being conducted to aid in the development and implementation of the version of the LIFT intervention that is optimized across domains of effect, feasibility, scalability, and costs.
METHODS AND ANALYSIS


The LIFT2 study is an optimization trial conceptualized as a component of a larger multiphase optimization strategy (MOST) project. The goal of LIFT2 is to use a 2 × 2 × 2 factorial experimental trial involving 152 patients to determine the ideal components of the LIFT mobile mindfulness program for ICU survivors across factors including (1) study introduction by call from a therapist vs. app only, (2) response to persistent or worsening symptoms over time by therapist vs. app only, and (3) high dose vs. low dose. The primary trial outcome is change in depression symptoms 1 month from randomization measured by the PHQ-9 instrument. Secondary outcomes include anxiety, post-traumatic stress disorder, and physical symptoms; measures of feasibility, acceptability, and usability; as well as themes assessed through qualitative analysis of semi-structured interviews with study participants conducted after follow up completion. We will use general linear models to compare outcomes across the main effects and interactions of the factors.",2020,"LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1).
","['152 patients to determine the ideal components of the LIFT mobile mindfulness program for ICU survivors across factors including (1) study introduction by call from a therapist vs. app only, (2) response to persistent or worsening symptoms over time by therapist vs. app only, and (3) high dose vs. low dose', ""cardiorespiratory failure survivors' psychological distress (LIFT2""]","['self-directed mobile mindfulness intervention', 'LIFT intervention', 'telephone-based mindfulness program or education control']","['change in depression symptoms 1\u202fmonth from randomization measured by the PHQ-9 instrument', 'LIFT reduced distress symptoms', 'anxiety, post-traumatic stress disorder, and physical symptoms; measures of feasibility, acceptability, and usability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C1444565', 'cui_str': 'Cardiorespiratory failure'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",152.0,0.143957,"LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1).
","[{'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Cox', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: christopher.cox@duke.edu.'}, {'ForeName': 'Maren K', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Department of Biostatistics, Duke University and the Center for Health Services Research in Primary Care, Durham VA Medical Center, Durham, NC, United States of America. Electronic address: maren.olsen@duke.edu.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Gallis', 'Affiliation': 'Center for Global Health, Duke University, Durham, NC, United States of America. Electronic address: john.gallis@duke.edu.'}, {'ForeName': 'Laura S', 'Initials': 'LS', 'LastName': 'Porter', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Duke University, Durham, NC, United States of America. Electronic address: laura.porter@duke.edu.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Greeson', 'Affiliation': 'Department of Psychology, College of Science and Mathematics, Rowan University, Glassboro, NJ, United States of America. Electronic address: greeson@rowan.edu.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Gremore', 'Affiliation': 'Department of Psychology, College of Science and Mathematics, Rowan University, Glassboro, NJ, United States of America. Electronic address: tina.gremore@duke.edu.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Frear', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: allie.frear@duke.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ungar', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Washington, Seattle, WA, United States of America. Electronic address: amu@uw.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'McKeehan', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Colorado, Denver, CO, United States of America. Electronic address: jeffrey.mckeehan@cuanschutz.edu.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'McDowell', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine and the Program to Support People and Enhance Recovery (ProSPER), Duke University, Durham, NC, United States of America. Electronic address: brittany.mcdowell@duke.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'McDaniel', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Colorado, Denver, CO, United States of America. Electronic address: hannah.mcdaniel@cuanschutz.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Moss', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Colorado, Denver, CO, United States of America. Electronic address: marc.moss@cuanschutz.edu.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Hough', 'Affiliation': 'Department of Medicine, Division of Pulmonary & Critical Care Medicine, University of Washington, Seattle, WA, United States of America. Electronic address: csterrlee@uw.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106119']
2397,32805520,Blunted salivary cortisol response to psychosocial stress in women with posttraumatic stress disorder.,"Posttraumatic stress disorder (PTSD) is characterized by alterations in the hypothalamic-pituitary-adrenal (HPA) axis and sympathetic nervous system (SNS). There is evidence for a blunted HPA axis reactivity to psychosocial stress. Less is known about how the SNS reacts to psychosocial stress. Here, we compared the HPA axis and SNS responses to psychosocial stress and a non-stressful condition in patients with PTSD and in healthy individuals. Twenty-one women with PTSD and 32 healthy women participated in the Trier social stress test (TSST) and placebo TSST (P-TSST). We measured salivary cortisol, alpha amylase activity and blood pressure before and after the tests. Subjective perceived stress response was also assessed. We found a blunted cortisol response to the TSST in patients with PTSD compared with healthy participants 10 min (t (51) = -2.58, p = .01) and 25 min (t (51) = -2.16, p = .04) after TSST. We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05). Patients with PTSD, but not healthy participants, reported more dissociative symptoms (t (20) = -2.31, p = .03) and being more tired (t (20) = 2.90, p = .01) directly after TSST compared with the placebo condition. Our results suggest a blunted HPA stress reactivity and an increased subjective perceived stress response in female patients with PTSD. Longitudinal studies could test if these altered stress responses constitute a predisposition to or a cause of PTSD. Future studies should investigate whether these results are transferable to men.",2020,We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05).,"['Posttraumatic stress disorder (PTSD', 'patients with PTSD and in healthy individuals', 'women with posttraumatic stress disorder', 'patients with PTSD compared with healthy participants 10\xa0min (t (51)\xa0', 'female patients with PTSD', 'Twenty-one women with PTSD and 32 healthy women participated in the']","['TSST', 'Trier social stress test (TSST) and placebo TSST (P-TSST']","['blunted cortisol response', 'blunted HPA stress reactivity', 'Subjective perceived stress response', 'SNS reactivity', 'dissociative symptoms', 'salivary cortisol, alpha amylase activity and blood pressure', 'Blunted salivary cortisol response']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C3715213', 'cui_str': '21'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",21.0,0.0110716,We found no evidence for an increased SNS reactivity after psychosocial stress in patients with PTSD (all p > .05).,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Metz', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany. Electronic address: sophie.metz@charite.de.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Duesenberg', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Hellmann-Regen', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Wolf', 'Affiliation': 'Department of Cognitive Psychology, Institute of Cognitive Neuroscience, Faculty of Psychology, Ruhr University, Bochum, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepke', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Otte', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Wingenfeld', 'Affiliation': 'Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.014']
2398,32805594,Behavioral changes in preterm children during nasogastric tube feeding. Comparative study of manual administration by parents versus mechanical administration via electric syringe pump.,"INTRODUCTION


Manual feeding by parents using a syringe, a widespread practice in Sweden since the 1980s, favors parents' involvement in childcare tasks. This approach is used in our neonatal unity since 2007.
OBJECTIVE


To study the behavioral changes of preterm children during nasogastric tube feeding: manual milk administration by parents (MAP) versus electric syringe administration (ESA) over a 30-minute period.
METHOD


This is a randomized, crossover study conducted in the neonatology unit of Toulouse. Preterm children under 33 weeks of age and over 7 days of life were included. A video recording was performed to assess the children's behavioral response, using the Dsilna score. The reviewer was blinded.
RESULTS


15 preterm children with a median gestational age of 30.1 weeks and a median birth weight of 1.210 g were included from March to October 2012. The facility, environment, and state of alertness of children were similar in both groups. Signs of well-being were significantly more prevalent in the MAP group versus the ESA group (36.2 (±8.0) versus 30.7 (±9.5)), (p = 0.04), particularly ""hand-to-mouth, mouth gestures, seeking suction and sucking"". Although not significant, motor withdrawal signs were more apparent and fluctuating in the ESA group. Qualitative analysis of NIDCAP observations confirms this data.
CONCLUSION


There are behavior changes of preterm children during nasogastric tube feeding. This pilot study showed previously undescribed results: MAP is associated with more common well-being signs and could be more widely used in neonatal units.",2020,"Signs of well-being were significantly more prevalent in the MAP group versus the ESA group (36.2 (±8.0) versus 30.7 (±9.5)), (p = 0.04), particularly ""hand-to-mouth, mouth gestures, seeking suction and sucking"".","['15 preterm children with a median gestational age of 30.1\xa0weeks and a median birth weight of 1.210\xa0g were included from March to October 2012', 'preterm children during nasogastric tube feeding', 'Preterm children under 33\xa0weeks of age and over 7\xa0days of life were included', 'preterm children']","['nasogastric tube feeding: manual milk administration by parents (MAP) versus electric syringe administration (ESA', 'manual administration by parents versus mechanical administration via electric syringe pump', 'ESA']","['Behavioral changes', 'motor withdrawal signs', 'facility, environment, and state of alertness of children']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0192456', 'cui_str': 'Nasogastric feeding'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0192456', 'cui_str': 'Nasogastric feeding'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0039142', 'cui_str': 'Syringe'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0181332', 'cui_str': 'Syringe pump'}]","[{'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C4304523', 'cui_str': 'Withdrawal sign'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]",15.0,0.0633833,"Signs of well-being were significantly more prevalent in the MAP group versus the ESA group (36.2 (±8.0) versus 30.7 (±9.5)), (p = 0.04), particularly ""hand-to-mouth, mouth gestures, seeking suction and sucking"".","[{'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Angot', 'Affiliation': 'Department of Neonatology, University Hospital, Children Hospital, Toulouse, France. Electronic address: angot-florent@laposte.net.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Van Vooren', 'Affiliation': 'Department of Neonatology, University Hospital, Children Hospital, Toulouse, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Castex', 'Affiliation': 'Department of Neonatology, University Hospital, Children Hospital, Toulouse, France; Nursery Hospital, Nîme, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Glorieux', 'Affiliation': 'Department of Neonatology, University Hospital, Children Hospital, Toulouse, France.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Casper', 'Affiliation': 'Department of Neonatology, University Hospital, Children Hospital, Toulouse, France; Department of Neonatology, University Hospital, Doha, Qatar.'}]",Early human development,['10.1016/j.earlhumdev.2020.105151']
2399,32805700,"The effect of circadian-adjusted LED-based lighting on sleep, daytime sleepiness and biomarkers of inflammation in a randomized controlled cross-over trial by pragmatic design in elderly care home dwellers.","AIM


Elderly multimorbid care home dwellers are a heterogenic group of frail individuals that exhibit sleep disturbances and a range of co-morbidities. The project aimed to study the possible effect of indoor circadian-adjusted LED-lighting (CaLED) in the elderly residents' care home on their sleeping patterns and systemic biomarkers associated with inflammation.
METHODS


A 16-week trial study was performed to follow the intervention and control groups using the Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) to monitor sleep and daytime sleepiness, and biomarkers IL-6, TNF-α and suPAR, to estimate the levels of inflammation.
RESULTS


There was no significant impact on sleep improvement after the short intervention time when analyzing the PSQI and ESS results. However, we found several challenges using these tools for this specific group of individuals. Thus, important knowledge was gained for future studies in elderly care home dwellers. The inflammation state throughout the entire study period was stable for most of the elderly and no significant change was detected from before to after the intervention. This study represents a first-to-date attempt to ameliorate the adverse effects of sleep disturbances that characterize a randomly chosen group of elderly multimorbid subjects, by using circadian-adjusted LED-lighting in a natural care home environment.
CONCLUSION


In this pragmatic randomized study of home dwelling individuals we were not able to demonstrate an improved sleep pattern as judged by PSQI, ESS or a change in inflammatory state.",2020,The inflammation state throughout the entire study period was stable for most of the elderly and no significant change was detected from before to after the intervention.,"['elderly care home dwellers', ""elderly residents' care home on their sleeping patterns and systemic biomarkers associated with inflammation"", 'elderly multimorbid subjects, by using circadian-adjusted LED-lighting in a natural care home environment', 'Elderly multimorbid care home dwellers are a heterogenic group of frail individuals that exhibit sleep disturbances and a range of co-morbidities', 'home dwelling individuals']","['indoor circadian-adjusted LED-lighting (CaLED', 'circadian-adjusted LED-based lighting']","['sleep improvement', 'inflammation state', 'sleep, daytime sleepiness and biomarkers of inflammation', 'Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) to monitor sleep and daytime sleepiness, and biomarkers IL-6, TNF-α and suPAR, to estimate the levels of inflammation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C3541276', 'cui_str': 'Epworth Sleepiness Scale'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0167666,The inflammation state throughout the entire study period was stable for most of the elderly and no significant change was detected from before to after the intervention.,"[{'ForeName': 'Christine Borgen', 'Initials': 'CB', 'LastName': 'Linander', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: christine.borgen.linander@regionh.dk.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kallemose', 'Affiliation': 'The Emergency Department, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: thomas.kallemose@regionh.dk.'}, {'ForeName': 'Lillian Moerch', 'Initials': 'LM', 'LastName': 'Joergensen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark; The Emergency Department, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: lillian.moerch.joergensen@regionh.dk.'}, {'ForeName': 'Ove', 'Initials': 'O', 'LastName': 'Andersen', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark; The Emergency Department, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: ove.andersen@regionh.dk.'}, {'ForeName': 'Jan O', 'Initials': 'JO', 'LastName': 'Nehlin', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: jan.nehlin@regionh.dk.'}, {'ForeName': 'Baker Nawfal', 'Initials': 'BN', 'LastName': 'Jawad', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital, Hvidovre, Denmark. Electronic address: baker.jawad@regionh.dk.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104223']
2400,32805715,A Randomized Study on the Effects of Minds in Motion and Yoga on Motor Proficiency and Academic Skills Among Elementary School Children.,"BACKGROUND


Physical activity is critical for the healthy development and well-being of children. Specifically, physical activity is associated with improvements in coordination, balance, attention, and behavior among elementary school-aged children. However, for many children, particularly those belonging to minority groups, opportunities to engage in quality physical activity programs outside school settings are limited. The purpose of this study was to examine the whether a physical activity program called Minds in Motion (MiM) The Maze before school, as compared with yoga, meets the criteria of the Comprehensive School Physical Activity Program framework as a before-school program to improve overall physical activity and academic performance among elementary school-age students.
METHODS


A total of 48 children attending an urban public school with large minority representation in the Midwest were randomly assigned to MiM-The Maze or yoga. Participants were assessed on motor proficiency, behavior, balance, and academic skills before and after training. Training consisted of either yoga or MiM-The Maze 30 minutes per day before school, 5 times per week for 12 weeks.
RESULTS


MiM-The Maze and yoga group students showed significant improvements in academic skills.
CONCLUSIONS


MiM-The Maze is feasible and affordable before-school program to promote students' classroom behavior in elementary school students.",2020,"Specifically, physical activity is associated with improvements in coordination, balance, attention, and behavior among elementary school-aged children.","['elementary school-age students', 'elementary school students', 'Elementary School Children', '48 children attending an urban public school with large minority representation in the Midwest', 'elementary school-aged children']","['MiM-The Maze or yoga', 'physical activity program called Minds in Motion (MiM', 'Minds in Motion and Yoga']","['coordination, balance, attention, and behavior', 'overall physical activity and academic performance', 'academic skills', 'motor proficiency, behavior, balance, and academic skills', 'Motor Proficiency and Academic Skills']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}]","[{'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0083355', 'cui_str': 'MAZE protocol'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}]",48.0,0.0135092,"Specifically, physical activity is associated with improvements in coordination, balance, attention, and behavior among elementary school-aged children.","[{'ForeName': 'Daniela G L', 'Initials': 'DGL', 'LastName': 'Terson de Paleville', 'Affiliation': ''}, {'ForeName': 'Jason C', 'Initials': 'JC', 'LastName': 'Immekus', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2019-0454']
2401,32805748,The Truview PCD™ Video Laryngoscope for Nasotracheal Intubation in Pediatric Patients: a Subset Analysis from a Prospective Randomized Controlled Trial.,"Video laryngoscopy has become increasingly popular for pediatric intubation. One novel FDA-approved video laryngoscope for children is the Truview PCD™ Pediatriclaryngoscope (Truphatek International Ltd., Netanya, Israel). This video laryngoscope employs continuous oxygen insufflation to the blade's tip, which defogs the lens and delays desaturation 1  .It has a 46° anterior viewing angle allowing visualization through either an eyepiece or video monitor and comes in sizes from neonatal to adults.",2020,"One novel FDA-approved video laryngoscope for children is the Truview PCD™ Pediatriclaryngoscope (Truphatek International Ltd., Netanya, Israel).",['Pediatric Patients'],"['Video laryngoscopy', 'FDA-approved video laryngoscope', 'Truview PCD™ Video Laryngoscope']",[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}]",[],,0.0696842,"One novel FDA-approved video laryngoscope for children is the Truview PCD™ Pediatriclaryngoscope (Truphatek International Ltd., Netanya, Israel).","[{'ForeName': 'Proshad N', 'Initials': 'PN', 'LastName': 'Efune', 'Affiliation': ""Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Children's Health Medical Center, Dallas, Texas, United States.""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Saynhalath', 'Affiliation': ""Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Children's Health Medical Center, Dallas, Texas, United States.""}, {'ForeName': 'James-Michael', 'Initials': 'JM', 'LastName': 'Blackwell', 'Affiliation': 'Department of Population and Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, Texas, United States.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Steiner', 'Affiliation': ""Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Children's Health Medical Center, Dallas, Texas, United States.""}, {'ForeName': 'Patrick N', 'Initials': 'PN', 'LastName': 'Olomu', 'Affiliation': ""Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Children's Health Medical Center, Dallas, Texas, United States.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Szmuk', 'Affiliation': ""Department of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Children's Health Medical Center, Dallas, Texas, United States.""}]",Paediatric anaesthesia,['10.1111/pan.14005']
2402,32805758,CALIBER: a phase II randomized feasibility trial of chemoablation with mitomycin-C vs surgical management in low-risk non-muscle-invasive bladder cancer.,We read with interest the article by Mostafid et al.(1) devoted to assessing the curative effects of chemoablation with endovescical mitomycin-C versus surgical management in low risk non-muscle invasive bladder cancer (defined as European Organisation for Research and Treatment of Cancer [EORTC] risk of recurrence score ≤6) with visual diagnosis of recurrence and no previous history of non-urothelial bladder cancer or high grade /≥T1 disease.,2020,disease.,['low-risk non-muscle-invasive bladder cancer'],"['endovescical mitomycin-C versus surgical management', 'mitomycin-C vs surgical management']",[],"[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.0445187,disease.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Montorsi', 'Affiliation': 'Department of Urology, San Raffaele Hospital and Scientific Institute, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moschini', 'Affiliation': 'Department of Urology, Luzerner Kantonsspital- Luzern, Switzerland.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Necchi', 'Affiliation': 'Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}]",BJU international,['10.1111/bju.15214']
2403,32806470,Reply to Capecitabine in combination with oxaliplatin or irinotecan in elderly patients with advanced colorectal cancer: results of a randomized phase II study.,,2010,,['elderly patients with advanced colorectal cancer'],"['Capecitabine', 'oxaliplatin or irinotecan']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]",[],,0.0140681,,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Rosati', 'Affiliation': 'Medical Oncology Unit, S. Carlo Hospital, Potenza, Italy. Electronic address: oncogerry@yahoo.it.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq451']
2404,32806954,Effect of K ATP  channel blocker glibenclamide on levcromakalim-induced headache.,"INTRODUCTION


Administration of ATP-sensitive potassium channel opener levcromakalim triggers headache in healthy volunteers and migraine attacks in migraine patients. Here, we investigated the effect of ATP-sensitive potassium channel blocker glibenclamide on levcromakalim-induced headache in healthy volunteers.
METHODS


In a randomized, double-blind, placebo-controlled, three-way cross-over study, 15 healthy volunteers aged 18-40 years were randomly allocated to receive glibenclamide and levcromakalim (day 1), glibenclamide and placebo (day 2), and placebo and placebo (day 3) on three different days separated by at least 1 week. The primary endpoints were the difference in incidence of headache and the difference in area under the curve for headache intensity scores (0-12 hours) between the days.
RESULTS


Fifteen healthy volunteers completed the 3 days of the study. More participants (12/15, 80%) developed headache on the glibenclamide-levcromakalim day compared to the glibenclamide-placebo day (5/15, 33%) ( p  = 0.01; mean difference 47%; 95% confidence interval 18-75%) and compared to the placebo-placebo day (1/15, 7%) ( p  = 0.001; mean difference 73%; 95% confidence interval 48-99%). We found no difference in headache incidence between glibenclamide-placebo day and placebo-placebo day ( p  = 0.12; mean difference 27%; 95% confidence interval 1.3-52%). The area under the curve for headache intensity was significantly larger on the glibenclamide-levcromakalim day compared to the glibenclamide-placebo day ( p  = 0.003); and compared to the placebo-placebo day ( p  = 0.001). We found no difference in the area under the curve between the glibenclamide-placebo day compared to the placebo-placebo day ( p  = 0.07). The median time to onset for headache after levcromakalim infusion with glibenclamide pretreatment was delayed (180 min) compared to levcromakalim without pretreatment (30 min) from a previously published study.
CONCLUSION


Glibenclamide administration did not cause headache, and glibenclamide pretreatment did not prevent levcromakalim-induced headache. However, glibenclamide delayed the onset of levcromakalim-induced headache. More selective blockers are needed to further elucidate the role of the ATP-sensitive potassium channel in headache initiation. Trial Registration:  ClinicalTrials.gov NCT03886922.",2020,p  = 0.001; mean difference 73%; 95% confidence interval 48-99%).,"['15 healthy volunteers aged 18-40 years', 'Fifteen healthy volunteers', 'healthy volunteers and migraine attacks in migraine patients', 'healthy volunteers']","['ATP-sensitive potassium channel opener levcromakalim triggers', 'K ATP  channel blocker glibenclamide', 'placebo-placebo', 'glibenclamide-placebo', 'glibenclamide and levcromakalim (day 1), glibenclamide and placebo (day 2), and placebo and placebo', 'glibenclamide', 'ATP-sensitive potassium channel blocker glibenclamide', 'Glibenclamide', 'placebo']","['headache', 'incidence of headache and the difference in area under the curve for headache intensity scores', 'levcromakalim-induced headache', 'area under the curve for headache intensity', 'median time to onset for headache', 'headache incidence', 'onset of levcromakalim-induced headache']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1955862', 'cui_str': 'ATP-Sensitive Potassium Channels'}, {'cui': 'C0244960', 'cui_str': 'Cromakalim, (3S-trans)-Isomer'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0001480', 'cui_str': 'Adenosine Triphosphate'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0244960', 'cui_str': 'Cromakalim, (3S-trans)-Isomer'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}]",15.0,0.445495,p  = 0.001; mean difference 73%; 95% confidence interval 48-99%).,"[{'ForeName': 'Mohammad Al-Mahdi', 'Initials': 'MA', 'LastName': 'Al-Karagholi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Hashmat', 'Initials': 'H', 'LastName': 'Ghanizada', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Kokoti', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Joachim S', 'Initials': 'JS', 'LastName': 'Paulsen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Jakob Møller', 'Initials': 'JM', 'LastName': 'Hansen', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420949863']
2405,32806958,"Disgusting Face, Disease-ridden Place?: Emoji Influence on the Interpretation of Restaurant Inspection Reports.","Every year, millions of Americans get sick from foodborne illness and it is estimated half of all reported instances occur at restaurants. To protect the public, regulators are encouraged to conduct restaurant inspections and disclose reports to consumers. However, inspection reporting format is inconsistent and typically contains information unclear to most consumers who often misinterpret the inspection results. Additionally, consumers are increasingly searching for this information in a digital context. Limited research explores inspection reports as communication tools. Using affect-as-information and ELM as theoretical frameworks, this experiment investigated how discrete emotions (e.g., disgust) conveyed through pictorial cues (i.e., emojis) influenced consumers' processing of inspection reports. Participants, recruited from Amazon's MTurk, were randomly assigned to one of six experimental conditions in a 3 (emoji: smiling vs. disgusted vs. none) x 2 (violation level: low vs. high) between-subjects design. Then, participants completed a questionnaire regarding perceptions and cognitive processing of the message. Results revealed that, compared to text, disgusted face emoji increased risk perceptions and avoidance behavior. In terms of emotion, smiling face emoji motivated participants to feel more emotions related to sanitation. In turn, positive feelings decreased elaboration likelihood. As predicted by ELM, involvement also predicted elaboration, such that participants who were highly involved with inspection reports elaborated more than those less involved. Involvement also moderated the relationship between emoji presented and elaboration. Practical implications are also discussed.",2020,"As predicted by ELM, involvement also predicted elaboration, such that participants who were highly involved with inspection reports elaborated more than those less involved.","[""Participants, recruited from Amazon's MTurk""]",[],['risk perceptions and avoidance behavior'],"[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0178494', 'cui_str': 'Avoidance behavior'}]",,0.0216902,"As predicted by ELM, involvement also predicted elaboration, such that participants who were highly involved with inspection reports elaborated more than those less involved.","[{'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Ray', 'Affiliation': 'School of Communication, Florida State University.'}, {'ForeName': 'Patrick F', 'Initials': 'PF', 'LastName': 'Merle', 'Affiliation': 'School of Communication, Florida State University.'}]",Health communication,['10.1080/10410236.2020.1802867']
2406,32806981,Effect of an Educational Intervention Based on Bandura's Theory on Foot Care Self-Efficacy in Diabetes: A Prospective Quasi-Experimental Study.,"The purpose of this study is to evaluate the foot care self-efficacy of diabetic foot patients and the effect of an educational intervention for improving it. This study was of a semi-experimental design and was conducted between January and December 2019 in a diabetic foot council of a university hospital. After power analysis to determine sample size, 33 participants meeting the inclusion criteria were included in the study. A Patient Identification Form and Diabetic Foot Care Self-Efficacy Scale (DFCSES) were used to collect data. Of the patients, 51.5% were male and the mean age was 54.91 ± 16.61 years. The mean score of DFCSES was 50.18 ± 20.88 before education and 72.67 ± 20.74 after education. The educational intervention has large effects on self-efficacy ( d  = 1.233), perceived knowledge level on diabetic foot ( d  = 1.102), perceived health status ( d  = 0.859), and perceived quality of life ( d  = 0.807). Educational intervention was found to be an effective way to improve foot care self-efficacy, perceived knowledge level on diabetic foot, perceived health status, and perceived quality of life.",2020,"Educational intervention was found to be an effective way to improve foot care self-efficacy, perceived knowledge level on diabetic foot, perceived health status, and perceived quality of life.","['Of the patients, 51.5% were male and the mean age was 54.91 ± 16.61 years', 'Diabetes', 'January and December 2019 in a diabetic foot council of a university hospital', '33 participants meeting the inclusion criteria were included in the study', 'diabetic foot patients']","['Educational intervention', 'educational intervention', ""Educational Intervention Based on Bandura's Theory on Foot Care""]","['foot care self-efficacy, perceived knowledge level on diabetic foot, perceived health status, and perceived quality of life', 'Care Self-Efficacy Scale (DFCSES', 'mean score of DFCSES', 'perceived quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0206172', 'cui_str': 'Diabetic foot'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0150240', 'cui_str': 'Foot care'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}, {'cui': 'C0206172', 'cui_str': 'Diabetic foot'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",33.0,0.0244155,"Educational intervention was found to be an effective way to improve foot care self-efficacy, perceived knowledge level on diabetic foot, perceived health status, and perceived quality of life.","[{'ForeName': 'İsmail', 'Initials': 'İ', 'LastName': 'Toygar', 'Affiliation': 'Ege University, Izmir, Turkey.'}, {'ForeName': 'Sadık', 'Initials': 'S', 'LastName': 'Hançerlioğlu', 'Affiliation': 'Ege University, Izmir, Turkey.'}, {'ForeName': 'Tülün', 'Initials': 'T', 'LastName': 'Utku', 'Affiliation': 'Ege University, Izmir, Turkey.'}, {'ForeName': 'Ilgın Yildirim', 'Initials': 'IY', 'LastName': 'Şimşir', 'Affiliation': 'Ege University, Izmir, Turkey.'}, {'ForeName': 'Şevki', 'Initials': 'Ş', 'LastName': 'Çetinkalp', 'Affiliation': 'Ege University, Izmir, Turkey.'}]",The international journal of lower extremity wounds,['10.1177/1534734620948327']
2407,32807013,Low-Frequency Repetitive Transcranial Magnetic Stimulation Over Contralesional Motor Cortex for Motor Recovery in Subacute Ischemic Stroke: A Randomized Sham-Controlled Trial.,"BACKGROUND


Low-frequency repetitive transcranial magnetic stimulation (rTMS) over the contralesional motor cortex (M1) has demonstrated beneficial effects on motor recovery, but evidence among patients with subacute stroke is lacking. We aimed to investigate whether 1-Hz rTMS over the contralesional M1 versus sham rTMS could improve arm function in patients with subacute ischemic stroke when combined with rehabilitative motor training.
METHODS


In total, 77 patients who were within 90 days after their first-ever ischemic stroke were enrolled and randomly allocated to either real (n = 40) or sham rTMS (n = 37). We delivered 1-Hz 30-minute active or sham rTMS before each daily 30-minute occupational therapy sessions over a 2-week period. The primary endpoint was changes in the Box and Block Test (BBT) score immediately after the end of treatment (EOT). Secondary analyses assessed changes in Fugl-Meyer assessment, Finger Tapping Test (FTT), Brunnstrom stage, and grip strength.
CLINICAL TRIAL REGISTRATION


ClinialTrials.gov (NCT02082015).
RESULTS


Changes in BBT immediately after the end of treatment did not differ significantly between the 2 groups ( P  = .267). Subgroup analysis according to cortical involvement revealed that real rTMS resulted in improvements in BBT at 1 month after EOT (17.4 ± 9.8 real vs 10.9 ± 10.3 sham;  P  = .023) and Brunnstrom stage of the hand immediately after EOT (0.6 ± 0.5 real vs 0.2 ± 0.5 sham;  P  = .023), only in the group without cortical involvement.
CONCLUSION


The effects of real and sham rTMS did not differ significantly among patients within 3 months poststroke. The location of stroke lesions should be considered for future clinical trials.",2020,"Subgroup analysis according to cortical involvement revealed that real rTMS resulted in improvements in BBT at 1 month after EOT (17.4 ± 9.8 real vs 10.9 ± 10.3 sham;  P  = .023) and Brunnstrom stage of the hand immediately after EOT (0.6 ± 0.5 real vs 0.2 ± 0.5 sham;  P  = .023), only in the group without cortical involvement.
","['Subacute Ischemic Stroke', '77 patients who were within 90 days after their first-ever ischemic stroke', 'patients within 3 months poststroke', 'patients with subacute stroke', 'patients with subacute ischemic stroke']","['contralesional M1 versus sham rTMS', '1-Hz rTMS', 'sham rTMS', 'Low-frequency repetitive transcranial magnetic stimulation (rTMS', 'Low-Frequency Repetitive Transcranial Magnetic Stimulation Over Contralesional Motor Cortex', '1-Hz 30-minute active or sham rTMS']","['Fugl-Meyer assessment, Finger Tapping Test (FTT), Brunnstrom stage, and grip strength', 'BBT', 'Box and Block Test (BBT) score']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0026607', 'cui_str': 'Motor cortex'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",77.0,0.483945,"Subgroup analysis according to cortical involvement revealed that real rTMS resulted in improvements in BBT at 1 month after EOT (17.4 ± 9.8 real vs 10.9 ± 10.3 sham;  P  = .023) and Brunnstrom stage of the hand immediately after EOT (0.6 ± 0.5 real vs 0.2 ± 0.5 sham;  P  = .023), only in the group without cortical involvement.
","[{'ForeName': 'Won-Seok', 'Initials': 'WS', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, South Korea.'}, {'ForeName': 'Bum Sun', 'Initials': 'BS', 'LastName': 'Kwon', 'Affiliation': 'Department of Rehabilitation Medicine, Dongguk University College of Medicine, Dongguk University Ilsan Hospital, Ilsandong-gu, Goyang, South Korea.'}, {'ForeName': 'Han Gil', 'Initials': 'HG', 'LastName': 'Seo', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, South Korea.'}, {'ForeName': 'Nam-Jong', 'Initials': 'NJ', 'LastName': 'Paik', 'Affiliation': 'Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, South Korea.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320948610']
2408,32810147,"An intimate partner violence prevention intervention for men, women, and couples in Ethiopia: Additional findings on substance use and depressive symptoms from a cluster-randomized controlled trial.","BACKGROUND


Intimate partner violence (IPV) is linked to substance use by male perpetrators and is associated with an increased risk of depression for women who experience violence. Unite for a Better Life (UBL) is a gender-transformative intervention delivered to men, women, and couples in Ethiopia; previous evidence demonstrated the intervention significantly reduced experience of and perpetration of IPV when delivered to men and led to more equitable household task-sharing when delivered to men and couples. The aim of this analysis is to assess engagement in the UBL intervention and to examine the relationship between random assignment to the intervention and men's past-year substance use and women's reported depressive symptoms as measured at the individual level.
METHODS AND FINDINGS


A sample of 64 villages in Gurague zone, Ethiopia, was randomly allocated to 4 arms (men's UBL, women's UBL, couples' UBL, or control). In each village, 106 households were randomly sampled, and households in the intervention arms were invited to participate in UBL, consisting of 14 sessions delivered by trained facilitators. Households in the control arm were offered a short educational session on IPV. Descriptive data on participant engagement in the intervention are reported, and outcomes assessed in an intention-to-treat (ITT) analysis include male use of substances (alcohol and khat) and women's depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9). Results from both adjusted and unadjusted specifications are reported, the latter adjusting for baseline covariates including age, education level, marriage length, polygamy, socioeconomic status, months between intervention and endline, and the baseline level of the outcome variable. The baseline sample includes 6,770 respondents surveyed in 2014-2015, and follow-up data were available from 88% of baseline respondents surveyed in 2017-2018; the majority of respondents report no education, and 61% are Muslim. Respondents reported high attendance rates and engagement in the intervention. In addition, there was evidence of a significant reduction in frequent past-year alcohol intoxication self-reported by men (adjusted odds ratio [AOR] = 0.56, 95% CI 0.36-0.85, p = 0.007), and a significant increase in the probability of frequent khat use self-reported by men (AOR = 3.09, 95% CI 1.37-6.96, p = 0.007), both observed in the couples' UBL arm at 24 months' follow-up relative to the control arm. There was a significant increase in symptoms of moderate depression among women in the women's UBL arm only (AOR = 1.65, 95% CI 1.13-2.41, p = 0.010), again relative to the control arm. There was no evidence of shifts in symptoms of mild or severe depression. The primary limitation of this study is the reliance on self-reported data around sensitive behaviors.
CONCLUSIONS


The findings suggest that the UBL intervention was associated with a reduction in men's use of alcohol when delivered to couples, but there was no evidence of a decrease in reported symptoms of depression among women in any experimental arm, and some evidence of an increase in symptoms of moderate depression in the women's UBL arm. Further research should explore how to optimize IPV prevention interventions to target related risks of mental health and substance use.
TRIAL REGISTRATION


Clinicaltrials.gov NCT02311699; Socialscienceregistry.org AEARCTR-0000211.",2020,"The findings suggest that the UBL intervention was associated with a reduction in men's use of alcohol when delivered to couples, but there was no evidence of a decrease in reported symptoms of depression among women in any experimental arm, and some evidence of an increase in symptoms of moderate depression in the women's UBL arm.","['106 households were randomly sampled, and households in the intervention arms were invited to participate in', 'men, women, and couples in Ethiopia', 'A sample of 64 villages in Gurague zone, Ethiopia', '6,770 respondents surveyed in 2014-2015, and follow-up data were available from 88% of baseline respondents surveyed in 2017-2018; the majority of respondents report no education, and 61% are Muslim', 'women who experience violence', 'Intimate partner violence (IPV']","['intimate partner violence prevention intervention', 'short educational session on IPV', 'UBL, consisting of 14 sessions delivered by trained facilitators', 'UBL intervention']","['Patient Health Questionnaire (PHQ-9', 'symptoms of mild or severe depression', 'symptoms of moderate depression', 'symptoms of depression', 'probability of frequent khat use self', 'frequent past-year alcohol intoxication self', 'depressive symptoms']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0588008', 'cui_str': 'Severe depression'}, {'cui': 'C0588007', 'cui_str': 'Moderate depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0066582', 'cui_str': 'Catha edulis'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}]",106.0,0.141212,"The findings suggest that the UBL intervention was associated with a reduction in men's use of alcohol when delivered to couples, but there was no evidence of a decrease in reported symptoms of depression among women in any experimental arm, and some evidence of an increase in symptoms of moderate depression in the women's UBL arm.","[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Leight', 'Affiliation': 'International Food Policy Research Institute, Washington, DC, United States of America.'}, {'ForeName': 'Negussie', 'Initials': 'N', 'LastName': 'Deyessa', 'Affiliation': 'Ethiopian Public Health Association, Addis Ababa, Ethiopia.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Verani', 'Affiliation': 'CARE, New York, United States of America.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Tewolde', 'Affiliation': 'EngenderHealth, Addis Ababa, Ethiopia.'}, {'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003131']
2409,32810194,"Parenting support to prevent overweight during regular well-child visits in 0-3 year old children (BBOFT+ program), a cluster randomized trial on the effectiveness on child BMI and health behaviors and parenting.","BACKGROUND


Prevention of overweight during early childhood seems promising.
OBJECTIVE


To evaluate the effectiveness of the parenting-based BBOFT+ overweight prevention program on child BMI, child health behavior and parenting behavior among 0-36 month old children. BBOFT+ is an acronym for the key healthy lifestyle behaviors that are targeted in the BBOFT+ intervention: breastfeeding (B), daily breakfast (B), daily going outdoors (O), limiting sweet beverages (in Dutch, F) and minimal TV or computer time (T), complemented with healthy sleep behavior and improvement of parenting skills (+).
METHODS


A cluster randomized controlled trial in newborn children visiting well-baby clinics, comparing the BBOFT+ intervention (N = 901) with care as usual (CAU) (N = 1094). In both groups, parents received regular well-child visits (±11 visits in the first 3 years). In the intervention group, care was supplemented with the BBOFT+ program, which focuses on improving parenting skills from birth onwards to increase healthy behavior. Questionnaires were filled in at child's age 2-4 weeks, 6, 14 and 36 months. In multivariate analyses we corrected for child's birthweight, age, ethnic background, mother's educational level and BMI.
RESULTS


No differences were found in weight status at 36 months between intervention and control group children. At 6 months, BBOFT+ parents reported their child drinking less sweet beverages than control parents (48% vs 54%;p = .027), and going outdoors daily with their child less often (57% vs 62%;p = .03). At 14 months, more BBOFT+ parents than control parents reported to have breastfed for six months or longer (32% vs 29%;p = .022). At 36 months, more BBOFT+ parents than control parents reported their child going outside daily (78% vs 72%;p = .011) and having less TV/computer time on week- (38% vs 46%;p = .001) and weekend days (48% vs 56%;p = .002). Also, BBOFT+ parents reported having more parental control than control parents (3.92 vs 3.89;p = .02). No significant differences were found for daily breakfast, sleep duration and parenting practices in adjusted analyses.
CONCLUSION


The BBOFT+ overweight prevention program showed small improvements in parent-reported child health behaviors, compared to care as usual; no effect was observed on child BMI. The identified modifiable elements are potentially relevant for interventions that aim to prevent overweight.",2020,"The BBOFT+ overweight prevention program showed small improvements in parent-reported child health behaviors, compared to care as usual; no effect was observed on child BMI.","['newborn children visiting well-baby clinics', 'N = 901) with care as usual (CAU) (N = 1094', 'overweight during regular well-child visits in 0-3 year old children (BBOFT+ program', 'child BMI, child health behavior and parenting behavior among 0-36 month old children']","['parenting-based BBOFT+ overweight prevention program', 'BBOFT+ intervention', 'BBOFT']","['child health behaviors', 'child BMI and health behaviors and parenting', 'child BMI', 'child going outside daily', 'daily breakfast, sleep duration and parenting practices', 'weight status']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0458075', 'cui_str': 'Well baby'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1444717', 'cui_str': 'Well child visit'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",901.0,0.0395653,"The BBOFT+ overweight prevention program showed small improvements in parent-reported child health behaviors, compared to care as usual; no effect was observed on child BMI.","[{'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Vlasblom', 'Affiliation': 'Department of Child Health, TNO, Leiden, The Netherlands.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'van Grieken', 'Affiliation': 'Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Beltman', 'Affiliation': 'Department of Child Health, TNO, Leiden, The Netherlands.'}, {'ForeName': 'Monique P', 'Initials': 'MP', 'LastName': ""L'Hoir"", 'Affiliation': 'Department of Human Nutrition and Health, Wageningen University & Research, Wageningen, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Raat', 'Affiliation': 'Department of Public Health, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Magda M', 'Initials': 'MM', 'LastName': 'Boere-Boonekamp', 'Affiliation': 'Department of Health Technology and Services Research, Technical Medical Centre, University of Twente, Enschede, The Netherlands.'}]",PloS one,['10.1371/journal.pone.0237564']
2410,32810203,Efficacy of high-power and short-duration ablation in patients with atrial fibrillation: a prospective randomized controlled trial.,"AIMS


The formation of radiofrequency lesions depends on the power and duration of ablation, and the contact force (CF). Although high power (HP) creates continuous and transmural lesions, most centres still use 25-30 W for 30-40 s for safety reasons. We evaluated the clinical efficacy and safety of a HP and short-duration (HPSD) strategy for atrial fibrillation (AF) ablation.
METHODS AND RESULTS


One hundred and fifty patients [58.2 ± 10.0 years, 48% with paroxysmal AF (PAF)] scheduled for index AF ablation using a CF-sensing catheter were randomly assigned to three groups [30 W, 40 W, and 50 W at ablation sites of anterior, roof, and inferior segments of pulmonary vein (PV) antra and roof line between each upper PV]. In 25-30 W for ≤20 s was applied at posterior wall ablation site in all subjects. Compared with the 30 W and 40 W groups, procedure (P < 0.001) and ablation times (P < 0.001) were shorter and ablation number for PV isolation (P < 0.001) was smaller in the 50 W group. There were no significant differences in the CF and ablation index (AI) among the three groups. There were no significant differences in the procedure-related complication rates. During the 12-month follow-up, AF recurred in 24 (16%) patients with no significant difference among the groups (P = 0.769). In the multivariate analysis, non-PAF [hazard ratio (HR) 2.836, P = 0.045] and AI (HR 0.983, P = 0.001) were independent risk factors for AF recurrence.
CONCLUSION


Radiofrequency ablation with HPSD is a safe and effective strategy with reduced ablation number and shortened procedure time compared to conventional ablation.",2020,"CONCLUSION


Radiofrequency ablation with HPSD is a safe and effective strategy with reduced ablation number and shortened procedure time compared to conventional ablation.","['One hundred and fifty patients [58.2\u2009±\u200910.0\u2009years, 48% with paroxysmal AF (PAF)] scheduled for index AF ablation using a CF-sensing catheter', 'patients with atrial fibrillation']","['HP and short-duration (HPSD) strategy', 'high-power and short-duration ablation', 'Radiofrequency ablation with HPSD']","['clinical efficacy and safety', 'shorter and ablation number for PV isolation', 'CF and ablation index (AI', 'ablation times', 'procedure-related complication rates']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",150.0,0.0286326,"CONCLUSION


Radiofrequency ablation with HPSD is a safe and effective strategy with reduced ablation number and shortened procedure time compared to conventional ablation.","[{'ForeName': 'Dong Geum', 'Initials': 'DG', 'LastName': 'Shin', 'Affiliation': 'Division of Cardiology, Hallym University Kangnam Sacred Heart Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jinhee', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Sang-Jin', 'Initials': 'SJ', 'LastName': 'Han', 'Affiliation': 'Division of Cardiology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do 14068, Republic of Korea.'}, {'ForeName': 'Hong Euy', 'Initials': 'HE', 'LastName': 'Lim', 'Affiliation': 'Division of Cardiology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do 14068, Republic of Korea.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euaa144']
2411,32810220,A phase 3 randomized study (HOMER) of ofatumumab vs rituximab in iNHL relapsed after rituximab-containing therapy.,"Because of high relapse rates with rituximab combinations, there is an unmet need for new therapeutic agents for treatment of indolent B-cell non-Hodgkin lymphoma (iNHL) or follicular lymphoma (FL). In previous trials, ofatumumab in combination with chemotherapy showed good results in relapsed/refractory FL pretreated with rituximab. This phase 3 trial evaluated the efficacy and safety of single-agent ofatumumab vs single-agent rituximab in rituximab-sensitive relapsed FL that relapsed at least 6 months after completing the last prior treatment with single-agent rituximab or a rituximab-containing regimen. Patients were randomized 1:1 to receive either ofatumumab (1000 mg) or rituximab (375 mg/m2) every week for 4 weeks for the induction phase, followed by once every 2 months for 4 additional doses. The primary endpoint, progression-free survival (PFS) and secondary endpoints, overall response rate (ORR) and overall survival (OS), were evaluated. Overall, 438 patients were assigned to receive ofatumumab (n = 219) and rituximab (n = 219). Baseline characteristics were similar in both arms. The independent review committee assessed whether median PFS was shorter in the ofatumumab arm than in the rituximab arm (16.33 vs 21.29 months), with no significant difference (hazard ratio, 1.15; 95% confidence interval, 0.89-1.49; P = .29) and also showed a lower ORR (50%) compared with the rituximab arm (66%). At the time of analysis, data were not matured for OS results. The number of grade >3 adverse events was higher in the ofatumumab arm (37%) than the rituximab arm (28%). Ofatumumab showed no superiority over rituximab in patients with FL who had relapsed after a rituximab-containing therapy. This study was registered at www.clinicaltrials.gov as #NCT01200589.",2020,The number of grade >3 adverse events was higher in the ofatumumab arm (37%) than the rituximab arm (28%).,"['438 patients were assigned to receive ofatumumab (n = 219) and', 'iNHL relapsed after rituximab-containing therapy', 'patients with FL who had relapsed after a rituximab-containing therapy']","['single-agent ofatumumab vs single-agent rituximab', 'ofatumumab (1000 mg) or rituximab', 'ofatumumab vs rituximab', 'rituximab-containing regimen', 'rituximab']","['number of grade >3 adverse events', 'progression-free survival (PFS) and secondary endpoints, overall response rate (ORR) and overall survival (OS', 'ORR', 'efficacy and safety', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1832027', 'cui_str': 'ofatumumab'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0079731', 'cui_str': 'B-cell lymphoma (clinical)'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C1832027', 'cui_str': 'ofatumumab'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",438.0,0.180547,The number of grade >3 adverse events was higher in the ofatumumab arm (37%) than the rituximab arm (28%).,"[{'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Maloney', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Michinori', 'Initials': 'M', 'LastName': 'Ogura', 'Affiliation': 'Department of Hematology/Oncology, Kasugai Municipal Hospital, Aichi, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Fukuhara', 'Affiliation': 'Department of Hematology and Rheumatology, Tohoku University Hospital, Miyagi, Japan.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Lasher', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland; and.'}, {'ForeName': 'Hiya', 'Initials': 'H', 'LastName': 'Banerjee', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Kensei', 'Initials': 'K', 'LastName': 'Tobinai', 'Affiliation': 'Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.'}]",Blood advances,['10.1182/bloodadvances.2020001942']
2412,32810378,Efficacy and safety profile of neuroendoscopic hematoma evacuation combined with intraventricular lavage in severe intraventricular hemorrhage patients.,"OBJECTIVE


The present study was conducted to explore the effect of neuroendoscopic hematoma evacuation in severe intraventricular hemorrhage (IVH).
METHODS


Totally 81 patients with severe IVH in our hospital from November 2017 to March 2019 were divided into the intervention group (38 cases who received neuroendoscopic hematoma evacuation combined with intraventricular lavage) and the control group (40 cases who received trepanation drainage). The perioperative condition, hematoma clearance rate, Glasgow coma score (GCS), hematoma recurrence rate, and prognosis were observed and compared between the two groups after treatment.
RESULTS


The operative time, time of cerebrospinal fluid drainage, and intracranial infection rate in the intervention group elicited superior results to those in the control group (p < .05). The clearance rate of hematoma in the intervention group was higher than that in the control group at 6 hr, 1, 3, and 7 days postoperatively (p < .05). The postoperative 3- and 7-day GCS scores in the intervention group were higher than those in the control group, and the recurrence rate of hematoma in the intervention group was significantly lower than that in the control group (p < .05), and the good/excellent rate of ADL in the intervention group was significantly higher than that in the control group (p < .05).
CONCLUSION


Neuroendoscopic hematoma evacuation combined with intraventricular lavage showed evident beneficial outcomes in patients with severe IVH. It can effectively improve the perioperative condition and improve the hematoma clearance rate and is beneficial to the prognosis of patients with severe IVH.",2020,"The postoperative 3- and 7-day GCS scores in the intervention group were higher than those in the control group, and the recurrence rate of hematoma in the intervention group was significantly lower than that in the control group (p < .05), and the good/excellent rate of ADL in the intervention group was significantly higher than that in the control group (p < .05).
","['severe intraventricular hemorrhage (IVH', 'patients with severe IVH', 'severe intraventricular hemorrhage patients', 'Totally 81 patients with severe IVH in our hospital from November 2017 to March 2019']","['Neuroendoscopic hematoma evacuation combined with intraventricular lavage', 'neuroendoscopic hematoma evacuation combined with intraventricular lavage', 'neuroendoscopic hematoma evacuation', 'neuroendoscopic hematoma evacuation combined with intraventricular lavage) and the control group (40 cases who received trepanation drainage']","['perioperative condition, hematoma clearance rate, Glasgow coma score (GCS), hematoma recurrence rate, and prognosis', 'operative time, time of cerebrospinal fluid drainage, and intracranial infection rate', 'postoperative 3- and 7-day GCS scores', 'excellent rate of ADL', 'recurrence rate of hematoma', 'clearance rate of hematoma', 'hematoma clearance rate']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C1261965', 'cui_str': 'Evacuation of hematoma'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0040836', 'cui_str': 'Trephination of cranium'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}, {'cui': 'C1271007', 'cui_str': 'Glasgow coma score'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023182', 'cui_str': 'Cerebrospinal fluid leak'}, {'cui': 'C4761018', 'cui_str': 'Intracranial infection'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]",81.0,0.0300706,"The postoperative 3- and 7-day GCS scores in the intervention group were higher than those in the control group, and the recurrence rate of hematoma in the intervention group was significantly lower than that in the control group (p < .05), and the good/excellent rate of ADL in the intervention group was significantly higher than that in the control group (p < .05).
","[{'ForeName': 'Hai-Tao', 'Initials': 'HT', 'LastName': 'Ding', 'Affiliation': 'Department of Neurosurgery, Linyi Central Hospital, Linyi, Shandong Province, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Neurosurgery, Linyi Central Hospital, Linyi, Shandong Province, China.'}, {'ForeName': 'De-Ke', 'Initials': 'DK', 'LastName': 'Sun', 'Affiliation': 'Department of Neurosurgery, Linyi Central Hospital, Linyi, Shandong Province, China.'}, {'ForeName': 'Quan-Min', 'Initials': 'QM', 'LastName': 'Nie', 'Affiliation': ""Department of Neurosurgery, Weifang People's Hospital, Weifang, Shandong Province, China.""}]",Brain and behavior,['10.1002/brb3.1756']
2413,32810380,"Quality-of-life impact after in-office treatment of nasal valve obstruction with a radiofrequency device: 2-year results from a multicenter, prospective clinical trial.","BACKGROUND


Insufficiency of the nasal valve is increasingly being recognized as a cause of nasal airway obstruction. The condition is associated with many symptoms, including nasal congestion, sleep disturbance, snoring, and an overall decline in quality of life (QoL). An in-office, minimally invasive radiofrequency treatment of the nasal valve has been associated with improved symptoms of nasal obstruction and patients' QoL for a 6-month period in a noncontrolled, prospective, single-arm study. The purpose of this study was to determine whether the results achieved with radiofrequency treatment at 6 months would be sustained through 24 months.
METHODS


Thirty-nine adult patients from an original cohort of 49 patients with severe to extreme Nasal Obstruction Symptom Evaluation (NOSE) Scale scores and dynamic or static internal nasal valve obstruction as the primary or significant contributor to obstruction were studied. Patients received intranasal bilateral radiofrequency treatment in a clinical study with a follow-up to 6 months, and were prospectively evaluated at 12, 18, and 24 months at 8 community-based otolaryngology practices. The patient-reported NOSE Scale score and 21 QoL questions were assessed.
RESULTS


Clinically significant improvement from baseline in NOSE Scale score change demonstrated at 6 months (mean, 55.9; standard deviation [SD], 23.6; p < 0.0001) was maintained through 24 months (mean, 53.5; SD, 24.6; p < 0.0001). Responders (≥15-point improvement) consisted of 92.3% of participants at 6 months and 97.2% at 24 months. Responses to the QoL questions also showed improvement in patients' QoL.
CONCLUSION


Treatment of the nasal valve with an in-office, transnasal temperature-controlled radiofrequency procedure was associated with stable and lasting improvement in symptoms of nasal obstruction and QoL through 24 months in this noncontrolled, single-arm study.",2020,"An in-office, minimally invasive radiofrequency treatment of the nasal valve has been associated with improved symptoms of nasal obstruction and patients' QoL for a 6-month period in a noncontrolled, prospective, single-arm study.",['Thirty-nine adult patients from an original cohort of 49 patients with severe to extreme Nasal Obstruction Symptom Evaluation (NOSE'],"['radiofrequency device', 'intranasal bilateral radiofrequency treatment']","['NOSE Scale score change', 'NOSE Scale score and 21 QoL questions', 'Scale scores and dynamic or static internal nasal valve obstruction', 'quality of life (QoL']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C3494438', 'cui_str': 'Symptom Evaluation'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0027429', 'cui_str': 'Nasal obstruction'}, {'cui': 'C3494438', 'cui_str': 'Symptom Evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]",49.0,0.0548052,"An in-office, minimally invasive radiofrequency treatment of the nasal valve has been associated with improved symptoms of nasal obstruction and patients' QoL for a 6-month period in a noncontrolled, prospective, single-arm study.","[{'ForeName': 'Moshe', 'Initials': 'M', 'LastName': 'Ephrat', 'Affiliation': 'ENT and Allergy Associates, Lake Success, New York, New York.'}, {'ForeName': 'Ofer', 'Initials': 'O', 'LastName': 'Jacobowitz', 'Affiliation': 'ENT and Allergy Associates, Lake Success, New York, New York.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Driver', 'Affiliation': 'ENT and Allergy Associates, Lake Success, New York, New York.'}]",International forum of allergy & rhinology,['10.1002/alr.22667']
2414,32810383,"Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of teneligliptin monotherapy in Chinese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise.","INTRODUCTION


Although the efficacy of teneligliptin, a highly selective dipeptidyl peptidase-4 inhibitor, has been amply studied for the treatment of type 2 diabetes, no clinical trials of teneligliptin have been conducted in China. We evaluated the efficacy and safety of teneligliptin monotherapy compared with placebo in Chinese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise.
MATERIALS AND METHODS


This multicenter, randomized, double-blind, placebo-controlled, parallel-group study, conducted at 42 sites, enrolled type 2 diabetes patients with glycosylated hemoglobin (HbA1c) 7.0%-<10.0% and fasting blood glucose (FPG) <270 mg/dL. Patients were randomly assigned, in a 1:1 ratio, to treatment with 20 mg teneligliptin or placebo (n=127, each) administered orally once daily before breakfast for 24 weeks. Change in HbA1c from baseline to Week 24 was the primary efficacy endpoint. Safety was assessed by the incidence of adverse events (AEs) and adverse drug reactions (ADRs).
RESULTS


The least square mean (LSM) change in HbA1c from baseline to Week 24 was -0.95% with teneligliptin vs -0.14% with placebo, yielding an LSM difference (teneligliptin vs placebo) of -0.80% (p<0.0001). For the secondary endpoint, from baseline to Week 24, the LSM change in FPG was -21.9 mg/dL with teneligliptin vs -1.4 mg/dL with placebo, yielding an LSM difference (teneligliptin vs placebo) of -20.5 mg/dL (p<0.0001). Th AE and ADR incidence rates, including hypoglycaemia, were similar in both groups.
CONCLUSIONS


At 24 weeks, teneligliptin was generally well tolerated and effective in Chinese T2DM patients with inadequately controlled with diet and exercise.",2020,"The least square mean (LSM) change in HbA1c from baseline to Week 24 was -0.95% with teneligliptin vs -0.14% with placebo, yielding an LSM difference (teneligliptin vs placebo) of -0.80% (p<0.0001).","['Chinese T2DM patients with inadequately controlled with diet and exercise', '42 sites, enrolled type 2 diabetes patients with glycosylated hemoglobin', 'Chinese patients with type 2 diabetes mellitus inadequately controlled with diet and exercise']","['teneligliptin', 'teneligliptin or placebo', 'placebo', 'LSM difference (teneligliptin vs placebo', 'teneligliptin monotherapy']","['hypoglycaemia', 'HbA1c', 'fasting blood glucose (FPG', 'incidence of adverse events (AEs) and adverse drug reactions (ADRs', 'tolerated and effective', 'efficacy and safety', 'LSM change in FPG', 'least square mean (LSM) change in HbA1c']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.39855,"The least square mean (LSM) change in HbA1c from baseline to Week 24 was -0.95% with teneligliptin vs -0.14% with placebo, yielding an LSM difference (teneligliptin vs placebo) of -0.80% (p<0.0001).","[{'ForeName': 'Linong', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': ""Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Nanjing First Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': ""Huai'an First People's Hospital, Huaian, Jiangsu, China.""}, {'ForeName': 'Jingdong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Jiangxi Province People's Hospital, Nanchang, Jiangxi, China.""}, {'ForeName': ""Jiao'e"", 'Initials': 'J', 'LastName': 'Zeng', 'Affiliation': 'Jingzhou Central Hospital, Jingzhou, Hubei, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Minhang Central Hospital, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Xiuzhen', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Tongji University, Tongji Hospital, Shanghai, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'The First Affiliated Hospital, University of South China, Hengyang, Hunan, China.'}, {'ForeName': 'Gen', 'Initials': 'G', 'LastName': 'Takayanagi', 'Affiliation': 'Mitsubishi Tanabe Pharma Development America, Inc, Jersey City, NJ, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Mitsubishi Tanabe Pharma Development (Beijing) Co., Ltd, Beijing, China.'}]",Journal of diabetes investigation,['10.1111/jdi.13389']
2415,32810391,"Reply to: Comment on ""Investigation of topical intranasal cocaine for sinonasal procedures: a randomized, phase III clinical trial"".",,2020,,['sinonasal procedures'],['topical intranasal cocaine'],[],"[{'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]",[],,0.027415,,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'McGrath', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Philadelphia College of Osteopathic Medicine, Philadelphia, PA.'}, {'ForeName': 'Alexa', 'Initials': 'A', 'LastName': 'McGrath', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Philadelphia College of Osteopathic Medicine, Philadelphia, PA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Burdett', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Philadelphia College of Osteopathic Medicine, Philadelphia, PA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Shokri', 'Affiliation': 'Otolaryngology and Facial Plastic Surgery Associates, Fort Worth, TX.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Cohn', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Division of Facial Plastic Reconstructive Surgery, Ochsner LSU Health, Shreveport, LA.'}]",International forum of allergy & rhinology,['10.1002/alr.22675']
2416,32810504,Acute exposure to traffic-related air pollution alters antioxidant status in healthy adults.,"BACKGROUND


Exposure to traffic-related air pollution is associated with an increased risk of cardiovascular and respiratory disease. Evidence suggests that inhaled pollutants precipitate these effects via multiple pathways involving oxidative stress.
OBJECTIVE


Postulating that a decrease in circulating antioxidant levels reflect an oxidative response, we investigated the effect of inhaled diesel exhaust (DE) on the ratio of reduced to oxidized glutathione (GSH/GSSG) in healthy adults, and whether pre-exposure antioxidant supplementation blunted this response. We also examined exposure-related changes in antioxidant/stress response leukocyte gene expression (GCLc, HMOX-1, IL-6, TGFβ) and plasma IL-6 levels.
METHODS


Nineteen nonsmoking adults participated in a double-blind, randomized, four-way crossover study. Each subject completed 120-min exposures to filtered air and DE (200 μg/m 3 ), with and without antioxidant pretreatment. Antioxidant comprised 1000 mg ascorbate for 7 days and 1200 mg N-acetylcysteine 1 day prior to exposure, with 1000 mg and 600 mg, respectively, administered 2 hours prior to exposure. Whole blood glutathione was measured pre- and post-exposure; plasma IL-6 and mRNA expression were quantified pre, during and post exposure.
RESULTS


Diesel exhaust exposure was associated with significantly decreased GSH/GSSG (p=0.001) and a 4-fold increase in IL-6 mRNA (p=0.01) post exposure. Antioxidant pretreatment did not significantly mediate the effect of DE exposure on GSH/GSSG, though appeared to decrease the effect of exposure on IL-6 mRNA expression.
CONCLUSIONS


Acute DE inhalation induced detectable oxidative effects in healthy adults, which were not significantly attenuated by the selected antioxidant pre-treatment. This finding supports the premise that oxidative stress is one mechanism underlying the adverse effects of traffic-related air pollution.",2020,"RESULTS


Diesel exhaust exposure was associated with significantly decreased GSH/GSSG (p=0.001) and a 4-fold increase in IL-6 mRNA (p=0.01) post exposure.","['Nineteen nonsmoking adults', 'healthy adults']","['traffic-related air pollution', 'Antioxidant', 'oxidized glutathione (GSH/GSSG', 'inhaled diesel exhaust (DE']","['GSH/GSSG', 'Whole blood glutathione was measured pre- and post-exposure; plasma IL-6 and mRNA expression', 'oxidative effects', 'antioxidant/stress response leukocyte gene expression (GCLc, HMOX-1, IL-6, TGFβ) and plasma IL-6 levels', 'IL-6 mRNA']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0012151', 'cui_str': 'Diesel Exhaust'}]","[{'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0061516', 'cui_str': 'Glutathione Disulfide'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",19.0,0.25279,"RESULTS


Diesel exhaust exposure was associated with significantly decreased GSH/GSSG (p=0.001) and a 4-fold increase in IL-6 mRNA (p=0.01) post exposure.","[{'ForeName': 'Kristen E', 'Initials': 'KE', 'LastName': 'Cosselman', 'Affiliation': 'Department of Environmental and Occupational Health Sciences. Electronic address: kecs@u.washington.edu.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Allen', 'Affiliation': 'Department of Environmental and Occupational Health Sciences.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jansen', 'Affiliation': 'Department of Environmental and Occupational Health Sciences.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Stapleton', 'Affiliation': 'Department of Environmental and Occupational Health Sciences.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Trenga', 'Affiliation': 'Department of Environmental and Occupational Health Sciences.'}, {'ForeName': 'Timothy V', 'Initials': 'TV', 'LastName': 'Larson', 'Affiliation': 'Department of Environmental and Occupational Health Sciences; Department of Civil and Environmental Engineering.'}, {'ForeName': 'Joel D', 'Initials': 'JD', 'LastName': 'Kaufman', 'Affiliation': 'Department of Environmental and Occupational Health Sciences; Department of Medicine; Department of Epidemiology, University of Washington, Seattle, WA, USA.'}]",Environmental research,['10.1016/j.envres.2020.110027']
2417,32810739,"The mitochondria-targeted antioxidant MitoQ, attenuates exercise-induced mitochondrial DNA damage.","High-intensity exercise damages mitochondrial DNA (mtDNA) in skeletal muscle. Whether MitoQ - a redox active mitochondrial targeted quinone - can reduce exercise-induced mtDNA damage is unknown. In a double-blind, randomized, placebo-controlled design, twenty-four healthy male participants consisting of two groups (placebo; n = 12, MitoQ; n = 12) performed an exercise trial of 4 x 4-min bouts at 90-95% of heart rate max. Participants completed an acute (20 mg MitoQ or placebo 1-h pre-exercise) and chronic (21 days of supplementation) phase. Blood and skeletal muscle were sampled immediately pre- and post-exercise and analysed for nuclear and mtDNA damage, lipid hydroperoxides, lipid soluble antioxidants, and the ascorbyl free radical. Exercise significantly increased nuclear and mtDNA damage across lymphocytes and muscle (P < 0.05), which was accompanied with changes in lipid hydroperoxides, ascorbyl free radical, and α-tocopherol (P < 0.05). Acute MitoQ treatment failed to impact any biomarker likely due to insufficient initial bioavailability. However, chronic MitoQ treatment attenuated nuclear (P < 0.05) and mtDNA damage in lymphocytes and muscle tissue (P < 0.05). Our work is the first to show a protective effect of chronic MitoQ supplementation on the mitochondrial and nuclear genomes in lymphocytes and human muscle tissue following exercise, which is important for genome stability.",2020,"However, chronic MitoQ treatment attenuated nuclear (P < 0.05) and mtDNA damage in lymphocytes and muscle tissue (P < 0.05).","['twenty-four healthy male participants consisting of two groups (placebo; n\xa0=\xa012, MitoQ; n\xa0=\xa012']","['High-intensity exercise damages mitochondrial DNA (mtDNA', 'MitoQ or placebo', 'placebo']","['Blood and skeletal muscle', 'lipid hydroperoxides, ascorbyl free radical, and α-tocopherol (P', 'nuclear and mtDNA damage across lymphocytes and muscle (P', 'mtDNA damage in lymphocytes and muscle tissue']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0023776', 'cui_str': 'Fatty Acid Hydroperoxides'}, {'cui': 'C0016693', 'cui_str': 'Free radical'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0012929', 'cui_str': 'Mitochondrial DNA'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",24.0,0.192572,"However, chronic MitoQ treatment attenuated nuclear (P < 0.05) and mtDNA damage in lymphocytes and muscle tissue (P < 0.05).","[{'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Williamson', 'Affiliation': 'Ulster University, Sport and Exercise Research Institute, Newtownabbey, Northern Ireland, UK.'}, {'ForeName': 'Ciara M', 'Initials': 'CM', 'LastName': 'Hughes', 'Affiliation': 'Ulster University, Nursing and Health Research Institute, Newtownabbey, Northern Ireland, UK.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Cobley', 'Affiliation': 'Free Radical Research Group, University of the Highlands and Islands, Centre for Health Sciences, Inverness, IV2 3JH, UK.'}, {'ForeName': 'Gareth W', 'Initials': 'GW', 'LastName': 'Davison', 'Affiliation': 'Ulster University, Sport and Exercise Research Institute, Newtownabbey, Northern Ireland, UK. Electronic address: gw.davison@ulster.ac.uk.'}]",Redox biology,['10.1016/j.redox.2020.101673']
2418,32810850,Combination of a probiotic and an antispasmodic increases quality of life and reduces symptoms in patients with irritable bowel syndrome: a pilot study.,"BACKGROUND


Probiotics and antispasmodics have been tested extensively in the management of symptoms of irritable bowel disease (IBS) but they have rarely been evaluated in combination. The objective of this pilot study was to assess the efficacy of treatment with the probiotic formulation i3.1 (Lactobacillus plantarum CECT7484 and CECT7485; Pediococcus acidilactici CECT7483), with or without the addition of the antispasmodic alverine/simethicone, in improving IBS-related quality of life (QoL) and reducing abdominal pain and diarrhea in patients with IBS.
METHODS


Randomized, placebo-controlled clinical trial with three parallel arms (probiotic, probiotic plus antispasmodic, placebo). Patients with IBS (N=55) were recruited at the Gastroenterology Department of the Juárez Hospital (México City). QoL was assessed with the IBS-QoL questionnaire, abdominal pain with a visual analog scale, and stool consistency with the Bristol scale.
RESULTS


The IBS-QoL rate of response (ITT analysis) was 50.0% for patients in the group with probiotic alone, 68.4% in the group with probiotic plus antispasmodic, and 16.7% in group with placebo after 6 weeks of treatment (p=0.005). Response to abdominal pain was reported by 38.9% patients treated with probiotic, 57.9% with probiotic plus antispasmodic, and 16.7% with placebo (p=0.035). Regarding stool consistency, a response to treatment was reported by 44.4% of patients treated with probiotic, 57.9% with probiotic plus antispasmodic, and 16.7% with placebo (p=0.032).
CONCLUSION


The results are consistent with previous studies on the use of the i3.1 probiotic formulation for the management of symptoms in IBS patients, and the addition of an antispasmodic improves its observed effects.",2020,"The IBS-QoL rate of response (ITT analysis) was 50.0% for patients in the group with probiotic alone, 68.4% in the group with probiotic plus antispasmodic, and 16.7% in group with placebo after 6 weeks of treatment (p=0.005).","['patients with irritable bowel syndrome', 'Patients with IBS (N=55) were recruited at the Gastroenterology Department of the Juárez Hospital (México City', 'patients with IBS']","['probiotic formulation i3.1 (Lactobacillus plantarum CECT7484 and CECT7485', 'probiotic plus antispasmodic, placebo', 'probiotic and an antispasmodic', 'placebo']","['IBS-related quality of life (QoL', 'IBS-QoL rate of response (ITT analysis', 'Response to abdominal pain', 'IBS-QoL questionnaire, abdominal pain with a visual analog scale, and stool consistency with the Bristol scale', 'quality of life and reduces symptoms', 'abdominal pain and diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0587464', 'cui_str': 'Gastroenterology department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037766', 'cui_str': 'Antispasmodic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",55.0,0.128962,"The IBS-QoL rate of response (ITT analysis) was 50.0% for patients in the group with probiotic alone, 68.4% in the group with probiotic plus antispasmodic, and 16.7% in group with placebo after 6 weeks of treatment (p=0.005).","[{'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Barraza-Ortiz', 'Affiliation': ''}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Pérez-López', 'Affiliation': ''}, {'ForeName': 'Víctor M', 'Initials': 'VM', 'LastName': 'Medina-López', 'Affiliation': ''}, {'ForeName': 'José I', 'Initials': 'JI', 'LastName': 'Minero-Alfaro', 'Affiliation': ''}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Zamarripa-Dorsey', 'Affiliation': ''}, {'ForeName': 'Nerina Del C', 'Initials': 'NDC', 'LastName': 'Fernández-Martínez', 'Affiliation': ''}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Llorente-Ramón', 'Affiliation': ''}, {'ForeName': 'Gustavo A', 'Initials': 'GA', 'LastName': 'Ramos-Aguilar', 'Affiliation': ''}]","Digestive diseases (Basel, Switzerland)",['10.1159/000510950']
2419,32810921,Insomnia as a mediating therapeutic target for depressive symptoms: A sub-analysis of participant data from two large randomized controlled trials of a digital sleep intervention.,"Insomnia predicts the onset of depression, commonly co-presents with depression and often persists following depression remission. However, these conditions can be challenging to treat concurrently using depression-specific therapies. Cognitive behavioural therapy for insomnia may be an appropriate treatment to improve both insomnia and depressive symptoms. We examined the effects of a fully-automated digital cognitive behavioural therapy intervention for insomnia (Sleepio) on insomnia and depressive symptoms, and the mediating role of sleep improvement on depressive symptoms in participants from two randomized controlled trials of digital cognitive behavioural therapy for insomnia. We also explored potential moderators of intervention effects. All participants met criteria for probable insomnia disorder and had clinically significant depressive symptomatology (PHQ-9 ≥ 10; n = 3,352). Individuals allocated to treatment in both trials were provided access to digital cognitive behavioural therapy. Digital cognitive behavioural therapy significantly improved insomnia (p < .001; g = 0.76) and depressive symptoms (p < .001; g = 0.48) at post-intervention (weeks 8-10), and increased the odds (OR = 2.9; 95% CI = 2.34, 3.65) of clinically significant improvement in depressive symptoms (PHQ-9 < 10). Improvements in insomnia symptoms at mid-intervention mediated 87% of the effects on depressive symptoms at post-intervention. No variables moderated effectiveness outcomes, suggesting generalizability of these findings. Our results suggest that effects of digital cognitive behavioural therapy for insomnia extend to depressive symptoms in those with clinically significant depressive symptomatology. Insomnia may, therefore, be an important therapeutic target to assist management of depressive symptoms.",2020,"Digital cognitive behavioural therapy significantly improved insomnia (p < .001; g = 0.76) and depressive symptoms (p < .001; g = 0.48) at post-intervention (weeks 8-10), and increased the odds (OR = 2.9; 95% CI = 2.34, 3.65) of clinically significant improvement in depressive symptoms (PHQ-9 ","['All participants met criteria for probable insomnia disorder and had clinically significant depressive symptomatology (PHQ-9\xa0≥\xa010; n\xa0=\xa03,352']","['digital sleep intervention', 'digital cognitive behavioural therapy', 'Cognitive behavioural therapy', 'Digital cognitive behavioural therapy', 'fully-automated digital cognitive behavioural therapy intervention']","['insomnia and depressive symptoms', 'insomnia', 'depressive symptoms (PHQ-9', 'insomnia symptoms', 'Insomnia', 'depressive symptoms']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205554', 'cui_str': 'Automated'}]","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.315371,"Digital cognitive behavioural therapy significantly improved insomnia (p < .001; g = 0.76) and depressive symptoms (p < .001; g = 0.48) at post-intervention (weeks 8-10), and increased the odds (OR = 2.9; 95% CI = 2.34, 3.65) of clinically significant improvement in depressive symptoms (PHQ-9 ","[{'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Big Health Inc., San Francisco, California, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Miller', 'Affiliation': 'Big Health Inc., San Francisco, California, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Emsley', 'Affiliation': ""Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Sheaves', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Annemarie I', 'Initials': 'AI', 'LastName': 'Luik', 'Affiliation': 'Department of Epidemiology, Erasmus MC University Medical Centre, Rotterdam, The Netherlands.'}, {'ForeName': 'Donna L', 'Initials': 'DL', 'LastName': 'Littlewood', 'Affiliation': 'NIHR Greater Manchester Patient Safety Translational Research Centre, University of Manchester, Manchester, UK.'}, {'ForeName': 'Kate E A', 'Initials': 'KEA', 'LastName': 'Saunders', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Kanady', 'Affiliation': 'Big Health Inc., San Francisco, California, USA.'}, {'ForeName': 'Jenna R', 'Initials': 'JR', 'LastName': 'Carl', 'Affiliation': 'Big Health Inc., San Francisco, California, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Davis', 'Affiliation': 'Big Health Inc., San Francisco, California, USA.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Kyle', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Big Health Inc., San Francisco, California, USA.'}]",Journal of sleep research,['10.1111/jsr.13140']
2420,32386474,"Enhanced recovery after video-assisted thoracoscopic surgery lobectomy: a prospective, historically controlled, propensity-matched clinical study.","Background


Enhanced recovery pathways or fast-tracking following surgery can decrease the rate of postoperative complications and hospital length of stay. The objectives of this study were to implement an enhanced recovery after surgery (ERAS) pathway for patients undergoing a video-assisted thoracoscopic surgery (VATS) lobectomy, to assess the safety and efficiency of this protocol by measuring associated postoperative outcomes, and to compare the outcomes for patients in the ERAS group with the outcomes for patients in a propensity-matched control group.
Methods


The study was a prospective clinical trial. Patients who were scheduled to undergo VATS lobectomy at the Centre hospitalier de l'Université de Montréal in Montréal, Quebec, Canada, were enrolled between November 2015 and October 2016. The ERAS pathway was used for all enrolled patients. The primary outcome was the number and severity of complications measured by the Comprehensive Complication Index. Secondary outcomes included length of stay, readmission and recovery. Recovery of patients was measured using EQ-5D-5L preoperatively and at 1 week, 1 month and 4 months after surgery. Prospectively enrolled patients were propensity matched to historical controls.
Results


Ninety-eight patients (36 men and 62 women) in the ERAS group and 98 patients in the control group (29 men and 69 women) were included in the analysis. The mean age was 65.2 ± 9.3 years, the mean body mass index (BMI) was 26.9 ± 5.9 kg/m2 and the median Charlson Comorbidity Index score was 2 (interquartile range [IQR] 2-3) in the ERAS group. In the control group, the mean age was 66.2 ± 9.4 years, the mean BMI was 27.4 ± 5.6 kg/m2 and the median Charlson Comorbidity Index score was 3 (IQR 2-3). A total of 23 patients (23.4%) in the ERAS group and 28 (28.6%) in the control group experienced 1 or more postoperative complications. The mean Comprehensive Complication Index score was 7.4 ± 16.8 in the ERAS group compared with 8.0 ± 14.3 in the control group (p = 0.79). The median postoperative length of stay was 3 days in the ERAS group and 5 days in the control group (p < 0.001). Five patients in the ERAS group and 4 patients in the control group were readmitted. The protocol adherence rate was 64.3%.
Conclusion


It is feasible to implement an enhanced recovery protocol after VATS lobectomy. Although the pathway is still early in its development in Canada, implementation of an ERAS pathway after VATS lobectomy was associated with decreased length of stay, with no observable increase in complication or readmission rates.",2020,The median postoperative length of stay was 3 days in the ERAS group and 5 days in the control group (p < 0.001).,"['The mean age was 65.2 ± 9.3 years, the mean body mass index (BMI) was 26.9 ± 5.9 kg/m2 and the median Charlson Comorbidity Index score was 2 (interquartile range [IQR] 2-3) in the ERAS group', 'Ninety-eight patients (36 men and 62 women) in the ERAS group and 98 patients in the control group (29 men and 69 women', 'patients in the ERAS group with the outcomes for patients in a propensity-matched control group', 'patients undergoing a', ""Patients who were scheduled to undergo VATS lobectomy at the Centre hospitalier de l'Université de Montréal in Montréal, Quebec, Canada, were enrolled between November 2015 and October 2016""]","['video-assisted thoracoscopic surgery (VATS) lobectomy', 'ERAS', 'video-assisted thoracoscopic surgery lobectomy']","['length of stay, readmission and recovery', 'number and severity of complications measured by the Comprehensive Complication Index', 'median postoperative length of stay', 'complication or readmission rates', 'rate of postoperative complications and hospital length of stay', 'median Charlson Comorbidity Index score', 'postoperative complications', 'length of stay', 'mean Comprehensive Complication Index score', 'protocol adherence rate']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C5197734', 'cui_str': 'Enhanced Postsurgical Recovery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C4520228', 'cui_str': 'Thoracoscopic surgical lobectomy using video-assisted guidance'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C4520228', 'cui_str': 'Thoracoscopic surgical lobectomy using video-assisted guidance'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",23.0,0.0567426,The median postoperative length of stay was 3 days in the ERAS group and 5 days in the control group (p < 0.001).,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Tahiri', 'Affiliation': 'From the Division of Thoracic Surgery, Université de Montréal, Montreal, Que. (Tahiri, Goudie, Jouquan, Thiffault, Martin, Ferraro, Liberman); and the CHUM Endoscopic Tracheobronchial and Oesophageal Centre (CETOC), Montreal, Que. (Tahiri, Goudie, Jouquan, Thiffault, Martin, Ferraro, Liberman).'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Goudie', 'Affiliation': 'From the Division of Thoracic Surgery, Université de Montréal, Montreal, Que. (Tahiri, Goudie, Jouquan, Thiffault, Martin, Ferraro, Liberman); and the CHUM Endoscopic Tracheobronchial and Oesophageal Centre (CETOC), Montreal, Que. (Tahiri, Goudie, Jouquan, Thiffault, Martin, Ferraro, Liberman).'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Jouquan', 'Affiliation': 'From the Division of Thoracic Surgery, Université de Montréal, Montreal, Que. (Tahiri, Goudie, Jouquan, Thiffault, Martin, Ferraro, Liberman); and the CHUM Endoscopic Tracheobronchial and Oesophageal Centre (CETOC), Montreal, Que. (Tahiri, Goudie, Jouquan, Thiffault, Martin, Ferraro, Liberman).'}, {'ForeName': 'Jocelyne', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'From the Division of Thoracic Surgery, Université de Montréal, Montreal, Que. (Tahiri, Goudie, Jouquan, Thiffault, Martin, Ferraro, Liberman); and the CHUM Endoscopic Tracheobronchial and Oesophageal Centre (CETOC), Montreal, Que. (Tahiri, Goudie, Jouquan, Thiffault, Martin, Ferraro, Liberman).'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Ferraro', 'Affiliation': 'From the Division of Thoracic Surgery, Université de Montréal, Montreal, Que. (Tahiri, Goudie, Jouquan, Thiffault, Martin, Ferraro, Liberman); and the CHUM Endoscopic Tracheobronchial and Oesophageal Centre (CETOC), Montreal, Que. (Tahiri, Goudie, Jouquan, Thiffault, Martin, Ferraro, Liberman).'}, {'ForeName': 'Moishe', 'Initials': 'M', 'LastName': 'Liberman', 'Affiliation': 'From the Division of Thoracic Surgery, Université de Montréal, Montreal, Que. (Tahiri, Goudie, Jouquan, Thiffault, Martin, Ferraro, Liberman); and the CHUM Endoscopic Tracheobronchial and Oesophageal Centre (CETOC), Montreal, Que. (Tahiri, Goudie, Jouquan, Thiffault, Martin, Ferraro, Liberman).'}]",Canadian journal of surgery. Journal canadien de chirurgie,['10.1503/cjs.001919']
2421,31992513,Impact of atrial fibrillation burden on cognitive function after left atrial ablation - Results of the MACPAF study.,"Atrial fibrillation (AF) is associated with cognitive decline and dementia irrespective of AF-related ischemic stroke. We investigated whether AF burden after ablation in patients with symptomatic paroxysmal AF has an impact on cognitive function. After enrolment to the prospective MACPAF study, study patients received an insertable loop recorder (ILR) and underwent serial neurological/cognitive assessment. To compare cognitive function, the delta of baseline and six months test results (Δ pre/post ) and a score to assess overall cognitive performance were computed. Thirty patients (median age 65 years (IQR 57-69), 40% female) were divided into groups according to median AF burden (<0.5% vs. ≥0.5%) after ablation. Overall cognitive performance did not differ in patients with an AF burden < 0.5% (median 120% [IQR 100-150]) vs. ≥0.5% (median 120% [IQR 100-160]) within six months after ablation (p = 0.74). Comparing Δ pre/post , patients with an AF burden ≥ 0.5% showed significantly better results in the digit-span backwards test (median + 1 [IQR 0 - +2 points]) compared to patients with an AF burden < 0.5% (median 0 [IQR -1-+1]) six months after ablation (p = 0.03). In patients with an AF burden < 0.5%, there was a statistical trend towards better results in the RAVLT test (median + 3 [IQR 0-+4]; p = 0.08) and the ROC test (median + 3 [IQR -1-+5; p = 0.07) compared to patients with an AF burden ≥ 0.5% (median -1 [IQR -3-+2] words and median -1 [IQR -5-+2] points, respectively). Therefore, AF burden had no significant impact on cognitive performance within six months after ablation. Clinical Trial Registration: clinicaltrials.gov NCT01061931.",2020,Overall cognitive performance did not differ in patients with an AF burden ,"['patients with an AF burden', 'Thirty patients (median age 65\xa0years (IQR 57-69), 40% female', 'patients with symptomatic paroxysmal AF']",['insertable loop recorder (ILR) and underwent serial neurological/cognitive assessment'],"['cognitive performance', 'cognitive function', 'median AF burden', 'overall cognitive performance', 'Overall cognitive performance', 'ROC test', 'digit-span backwards test']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}]","[{'cui': 'C0445022', 'cui_str': 'Loop'}, {'cui': 'C0182913', 'cui_str': 'Recorder'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0439781', 'cui_str': 'Backward'}]",,0.0812262,Overall cognitive performance did not differ in patients with an AF burden ,"[{'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Herm', 'Affiliation': 'Department of Neurology, Charité - Universitätsmedizin Berlin, Germany; Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Schirdewan', 'Affiliation': ''}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Koch', 'Affiliation': 'General Medical Practice, Dresden, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Wutzler', 'Affiliation': 'Cardiovascular Center, University Hospital of the Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Jochen B', 'Initials': 'JB', 'LastName': 'Fiebach', 'Affiliation': 'Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Department of Neurology, Charité - Universitätsmedizin Berlin, Germany; Center for Stroke Research Berlin, Charité - Universitätsmedizin Berlin, Germany; Berlin Institute of Health (BIH), Berlin, Germany; German Center for Neurodegenerative Diseases (DZNE), Partner Site, Berlin, Germany; German Center for Cardiovascular Research (DZHK), Partner Site, Berlin, Germany.'}, {'ForeName': 'Ute A', 'Initials': 'UA', 'LastName': 'Kopp', 'Affiliation': 'Department of Neurology, Charité - Universitätsmedizin Berlin, Germany.'}, {'ForeName': 'Karl Georg', 'Initials': 'KG', 'LastName': 'Haeusler', 'Affiliation': 'Department of Neurology, Universitätsklinikum Würzburg, Würzburg, Germany. Electronic address: Haeusler_K@ukw.de.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2019.12.030']
2422,32000957,Sustained Low-Density Lipoprotein Cholesterol Lowering With Alirocumab in ODYSSEY OUTCOMES.,,2020,,[],[],[],[],[],[],,0.137669,,"[{'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ''}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': ''}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ''}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': ''}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': ''}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Harrington', 'Affiliation': ''}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': ''}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': ''}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2019.11.030']
2423,32807086,Assessing the effectiveness of statin therapy for alleviating cerebral small vessel disease progression in people ≥75 years of age.,"BACKGROUND


Statins have been recommended by several guidelines as the primary prevention medication for cardiovascular diseases. However, the benefits of statin therapy for cerebral small vessel disease (CSVD), particularly in adults ≥75 years of age, have not been fully evaluated.
METHODS


We analyzed the data from a prospective population-based cohort study and a randomized, double-blind, placebo-controlled clinical trial to determine whether statin therapy might aid in slowing the progression of CSVD in adults ≥75 years of age. For the cohort study, 827 participants were considered eligible and were included in the baseline analysis. Subsequently, 781 participants were included in follow-up analysis. For the clinical trial, 227 participants were considered eligible and were used in the baseline and follow-up analyses.
RESULTS


The white matter hyperintensities (WMH) volume, the WMH-to-intracranial volume (ICV) ratio, the prevalence of a Fazekas scale score ≥ 2, lacunes, enlarged perivascular spaces (EPVS), and microbleeds were significantly lower in the statin group than the non-statin group at baseline in the cohort study (all P < 0.05). During the follow-up period, in both the cohort and clinical trial studies, the WMH volume and WMH-to-ICV ratio were significantly lower in the statin/rosuvastatin group than the non-statin/placebo group (all P < 0.001). Statin therapy was associated with lower risk of WMH, lacunes, and EPVS progression than the non-statin therapy group after adjustment for confounders (all P < 0.05). There was no statistically significant difference in the risk of microbleeds between the statin and non-statin therapy groups (all, P > 0.05).
CONCLUSIONS


Our findings indicated that statin therapy alleviated the progression of WMH, lacunes, and EPVS without elevating the risk of microbleeds. On the basis of the observed results, we concluded that statin therapy is an efficient and safe intervention for CSVD in adults ≥75 years of age.
TRIAL REGISTRATION


Chictr.org.cn: ChiCTR-IOR-17013557 , date of trial retrospective registration November 27, 2017 and ChiCTR-EOC-017013598 , date of trial retrospective registration November 29, 2017.",2020,"Statin therapy was associated with lower risk of WMH, lacunes, and EPVS progression than the non-statin therapy group after adjustment for confounders (all P < 0.05).","['227 participants were considered eligible and were used in the baseline and follow-up analyses', '781 participants were included in follow-up analysis', '827 participants were considered eligible and were included in the baseline analysis', 'adults ≥75\u2009years of age', 'people ≥75\u2009years of age']","['statin/rosuvastatin', 'statin therapy', 'Statin therapy', 'placebo']","['white matter hyperintensities (WMH) volume, the WMH-to-intracranial volume (ICV) ratio, the prevalence of a Fazekas scale score\u2009≥\u20092, lacunes, enlarged perivascular spaces (EPVS), and microbleeds', 'risk of microbleeds', 'WMH volume and WMH-to-ICV ratio', 'cerebral small vessel disease progression', 'lower risk of WMH, lacunes, and EPVS progression', 'progression of WMH, lacunes, and EPVS']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442800', 'cui_str': 'Enlarged'}, {'cui': 'C0225983', 'cui_str': 'Structure of perivascular space'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C2733158', 'cui_str': 'Small vessel cerebrovascular disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]",227.0,0.0837268,"Statin therapy was associated with lower risk of WMH, lacunes, and EPVS progression than the non-statin therapy group after adjustment for confounders (all P < 0.05).","[{'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Basic Medical College, Shandong First Medical University, Jinan, 250062, Shandong, China.'}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Medicine and Life Sciences, Shandong First Medical University, Zhangqiu, 250202, Shandong, China.'}, {'ForeName': 'Xukui', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Medicine and Life Sciences, Shandong First Medical University, Zhangqiu, 250202, Shandong, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Radiology, Shandong University Qilu Hospital, Jinan, 250012, Shandong, China.'}, {'ForeName': 'Yingxin', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Basic Medical College, Shandong First Medical University, Jinan, 250062, Shandong, China.'}, {'ForeName': 'Shangwen', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'Basic Medical College, Shandong First Medical University, Jinan, 250062, Shandong, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Jia', 'Affiliation': 'Basic Medical College, Shandong First Medical University, Jinan, 250062, Shandong, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chai', 'Affiliation': 'Basic Medical College, Shandong First Medical University, Jinan, 250062, Shandong, China.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Gong', 'Affiliation': 'The Russel H. Morgan Department of Radiology and Radiological Sciences, the Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Basic Medical College, Shandong First Medical University, Jinan, 250062, Shandong, China. huazhang0709@163.com.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Basic Medical College, Shandong First Medical University, Jinan, 250062, Shandong, China. zhendongliu876@126.com.'}]",BMC geriatrics,['10.1186/s12877-020-01682-w']
2424,32807113,"The efficacy of a leukotriene receptor antagonist in the treatment of human rectal aberrant crypt foci: a nonrandomized, open-label, controlled trial.","BACKGROUND


Leukotriene receptor antagonists (LTRAs) are broadly used for the management of allergic asthma and have recently been indicated to inhibit carcinogenesis and cancer cell growth. In colorectal cancer (CRC) chemoprevention studies, the occurrence of adenoma or CRC itself is generally set as the trial endpoint. Although the occurrence rate of CRC is the most confident endpoint, it is inappropriate for chemoprevention studies because CRC incidence rate is low in the general population and needed for long-term monitoring. Aberrant crypt foci (ACF), defined as lesions containing crypts that are larger in diameter and darker in methylene blue staining than normal crypts, are regarded to be a fine surrogate biomarker of CRC. Therefore, this prospective study was designed to explore the chemopreventive effect of LTRA on colonic ACF formation and the safety of the medicine in patients scheduled for a poly resection as a pilot trial leading the CRC chemoprevention trial.
METHODS


This study is a nonrandomized, open-label, controlled trial in patients with colorectal ACF and polyps scheduled for a polypectomy. Participants meet the inclusion criteria will be recruited, and the number of ACF in the rectum will be counted at the baseline colonoscopic examination. Next, the participants will be assigned to the LTRA or no treatment group. Participants in the LTRA group will continue 10 mg of oral montelukast for 8 weeks, and those in the no treatment group will be observed without the administration of any additional drugs. At the end of the 8-week LTRA intervention period, a polypectomy will be conducted to evaluate the changes in the number of ACF, and cell proliferation in the normal colorectal epithelium will be analyzed.
DISCUSSION


This will be the first study to investigate the effect of LTRAs on colorectal ACF formation in humans.
TRIAL REGISTRATION


This trial has been registered in the University Hospital Medical Information Network (UMIN) Clinical Trials Registry as UMIN000029926 . Registered 10 November 2017.",2020,"Aberrant crypt foci (ACF), defined as lesions containing crypts that are larger in diameter and darker in methylene blue staining than normal crypts, are regarded to be a fine surrogate biomarker of CRC.","['humans', 'patients scheduled for a poly resection as a pilot trial leading the CRC chemoprevention trial', 'patients with colorectal ACF and polyps scheduled for a polypectomy', 'University Hospital Medical Information Network (UMIN', 'human rectal aberrant crypt foci']","['LTRA', 'Leukotriene receptor antagonists (LTRAs', 'leukotriene receptor antagonist', 'oral montelukast', 'LTRAs']","['colonic ACF formation', 'Aberrant crypt foci (ACF']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0032400', 'cui_str': 'Poly(rA)'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C1879526', 'cui_str': 'Aberrant Crypt Foci'}, {'cui': 'C0032584', 'cui_str': 'Polyp'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021419', 'cui_str': 'Information Networks'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}]","[{'cui': 'C0595726', 'cui_str': 'Leukotriene receptor antagonist'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0298130', 'cui_str': 'montelukast'}]","[{'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C1879526', 'cui_str': 'Aberrant Crypt Foci'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}]",,0.0512029,"Aberrant crypt foci (ACF), defined as lesions containing crypts that are larger in diameter and darker in methylene blue staining than normal crypts, are regarded to be a fine surrogate biomarker of CRC.","[{'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Higurashi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan. takuma_h@yokohama-cu.ac.jp.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Arimoto', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Ashikari', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Takatsu', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Misawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Yoshihara', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Matsuura', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Fuyuki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Ohkubo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakajima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine, 3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, 236-0004, Japan.'}]",BMC cancer,['10.1186/s12885-020-07266-6']
2425,32807151,Theoretically designed interventions for colorectal cancer prevention: a case of the health belief model.,"BACKGROUND


According to the WHO, most chronic diseases, including cancer, can be prevented by identifying their risk factors such as unhealthy diet, smoking and physical inactivity. This research examined the effectiveness of a theory-based educational intervention on colorectal cancer-related preventive nutritional behaviors among a sample of organizational staff.
METHODS


In this interventional study, 110 employees of Shahid Beheshti University of Medical Sciences were randomly divided into two groups (intervention and control) with cluster sampling. The data gathering tool was a researcher-made questionnaire containing two parts of 10-dimensional information and health belief model constructs. The educational intervention was conducted for 1 month and in four sessions in the form of classroom lecture, pamphlet, educational text messages via mobile phones and educational pamphlets through the office automation system. Two groups were evaluated in two stages, pre-test and post-test. Data were analyzed using SPSS-18 software, analysis of Covariance (ANCOVA) and independent t-test (intergroup comparisons).
RESULTS


Two groups were evaluated for variables such as age, sex, education level and family history of colorectal cancer, and there was no significant difference between the two groups (P < 0.05). After the 2 months since intervention, except for the mean score of perceived barriers, which was not significant after intervention, the mean scores of knowledge, perceived susceptibility, perceived severity, perceived benefits, perceived self-efficacy, behavioral intention, and preventive behaviors were significantly increased after the intervention in the intervention group compared to the control group (P > 0.05).
CONCLUSION


Implementation of educational intervention based on health belief model was effective for the personnel, and can enhance the preventative nutritional behaviors related to colorectal cancer.",2020,"After the 2 months since intervention, except for the mean score of perceived barriers, which was not significant after intervention, the mean scores of knowledge, perceived susceptibility, perceived severity, perceived benefits, perceived self-efficacy, behavioral intention, and preventive behaviors were significantly increased after the intervention in the intervention group compared to the control group (P > 0.05).
",['110 employees of Shahid Beheshti University of Medical Sciences'],"['classroom lecture, pamphlet, educational text messages via mobile phones and educational pamphlets through the office automation system', 'educational intervention', 'theory-based educational intervention']","['mean scores of knowledge, perceived susceptibility, perceived severity, perceived benefits, perceived self-efficacy, behavioral intention, and preventive behaviors']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0028893', 'cui_str': 'Automation, Office'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}]",110.0,0.0144727,"After the 2 months since intervention, except for the mean score of perceived barriers, which was not significant after intervention, the mean scores of knowledge, perceived susceptibility, perceived severity, perceived benefits, perceived self-efficacy, behavioral intention, and preventive behaviors were significantly increased after the intervention in the intervention group compared to the control group (P > 0.05).
","[{'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Rakhshanderou', 'Affiliation': 'Environmental and Occupational Hazards Control Research Center, School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Maghsoudloo', 'Affiliation': 'School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Safari-Moradabadi', 'Affiliation': 'School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohtasham', 'Initials': 'M', 'LastName': 'Ghaffari', 'Affiliation': 'Environmental and Occupational Hazards Control Research Center, School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, Iran. mohtashamghaffari@sbmu.ac.ir.'}]",BMC medical education,['10.1186/s12909-020-02192-4']
2426,32807157,Peer support to maintain psychological wellbeing in people with advanced cancer: findings from a feasibility study for a randomised controlled trial.,"BACKGROUND


Advanced cancer affects people's lives, often causing stress, anxiety and depression. Peer mentor interventions are used to address psychosocial concerns, but their outcomes and effect are not known. Our objective was to determine the feasibility of delivering and investigating a novel peer mentor intervention to promote and maintain psychological wellbeing in people with advanced cancer.
METHODS


A mixed methods design incorporating a two-armed controlled trial (random allocation ratio 1:1) of a proactive peer mentor intervention plus usual care, vs. usual care alone, and a qualitative process evaluation. Peer mentors were recruited, trained, and matched with people with advanced cancer. Quantitative data assessed quality of life, coping styles, depression, social support and use of healthcare and other supports. Qualitative interviews probed experiences of the study and intervention.
RESULTS


Peer mentor training and numbers (n = 12) met feasibility targets. Patient participants (n = 12, from 181 eligible who received an information pack) were not recruited to feasibility targets. Those who entered the study demonstrated that intervention delivery and data collection were feasible. Outcome data must be treated with extreme caution due to small numbers, but indicate that the intervention may have a positive effect on quality of life.
CONCLUSIONS


Peer mentor interventions are worthy of further study and researchers can learn from these feasibility data in planning participant recruitment and data collection strategies. Pragmatic trials, where the effectiveness of an intervention is tested in real-world routine practice, may be most appropriate. Peer mentor interventions may have merit in enabling survivors with advanced cancer cope with their disease.
TRIAL REGISTRATION


The trial was prospectively registered 13.6.2016: ISRCTN10276684 .",2020,"Our objective was to determine the feasibility of delivering and investigating a novel peer mentor intervention to promote and maintain psychological wellbeing in people with advanced cancer.
","['survivors with advanced cancer cope with their disease', 'people with advanced cancer', 'Patient participants (n\u2009=\u200912, from 181 eligible who received an information pack', 'Peer mentors were recruited, trained, and matched with people with advanced cancer']","['novel peer mentor intervention', 'Peer support to maintain psychological wellbeing', 'Peer mentor interventions', 'proactive peer mentor intervention plus usual care, vs. usual care alone']","['quality of life', 'quality of life, coping styles, depression, social support and use of healthcare and other supports']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0183683', 'cui_str': 'Support'}]",,0.17855,"Our objective was to determine the feasibility of delivering and investigating a novel peer mentor intervention to promote and maintain psychological wellbeing in people with advanced cancer.
","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Walshe', 'Affiliation': 'International Observatory on End of Life Care, Division of Health Research, Lancaster University, Bailrigg, Lancaster, UK. c.walshe@lancaster.ac.uk.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Roberts', 'Affiliation': 'Division of Nursing, Midwifery and Social Work, Manchester University, Manchester, UK.'}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Calman', 'Affiliation': 'Macmillan Survivorship Research Group, School of Health Sciences, Southampton University, Southampton, UK.'}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Appleton', 'Affiliation': 'Clatterbridge Cancer Centre NHS Foundation Trust, Wirral, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Croft', 'Affiliation': ', Liverpool, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Skevington', 'Affiliation': 'Manchester Centre for Health Psychology, School of Psychological Sciences, Manchester University, Manchester, UK.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Lloyd-Williams', 'Affiliation': 'APSCSG, Institute of Population and Health Sciences, Liverpool, UK.'}, {'ForeName': 'Gunn', 'Initials': 'G', 'LastName': 'Grande', 'Affiliation': 'Division of Nursing, Midwifery and Social Work, Manchester University, Manchester, UK.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Perez Algorta', 'Affiliation': 'Division of Health Research, Lancaster University, Lancaster, UK.'}]",BMC palliative care,['10.1186/s12904-020-00631-z']
2427,32807179,High-intensity interval training and health-related quality of life in de novo heart transplant recipients - results from a randomized controlled trial.,"BACKGROUND


Studies on the effect of high-intensity interval training (HIT) compared with moderate intensity continuous training (MICT) on health-related quality of life (HRQoL) after heart transplantation (HTx) is scarce. No available studies among de novo HTx recipients exists. This study aimed to investigate the effect of HIT vs. MICT on HRQoL in de novo recipients.
METHODS


The HITTS study randomized eighty-one de novo HTx recipients to receive either HIT or MICT (1:1). The HIT intervention were performed with 2-4 interval bouts with an intensity of 85-95% of maximal effort. The MICT group exercised at an intensity of 60-80% of their maximal effort with a duration of 25 min. HRQoL was assessed by the Short Form-36 version 2 (SF-36v2) and the Hospital Anxiety and Depression Scale, mean 11 weeks after surgery and after a nine months' intervention. The participants recorded their subjective effect of the interventions on their general health and well-being on a numeric visual analogue scale. Clinical examinations and physical tests were performed. Differences between groups were investigated with independent Student t-tests and with Mann-Whitney U tests where appropriate. Within-group differences were analyzed with Paired-Sample t-tests and Wilcoxon Signed Rank tests. Correlations between SF-36 scores and VO 2peak  were examined with Pearson's correlations.
RESULTS


Seventy-eight participants completed the intervention. Both exercise modes were associated with improved exercise capacity on the physical function scores of HRQoL. Mental health scores remained unchanged. No differences in the change in HRQoL between the groups occurred except for Role Emotional subscale with a larger increase in the HIT arm. Better self-reported physical function was associated with higher VO 2peak  and muscle strength.
CONCLUSION


HIT and MICT resulted in similar mean changes in HRQoL the first year after HTx. Both groups experienced significant improvements in the physical SF-36v2.
TRIAL REGISTRATION


ClinicalTrials.gov number: NCT01796379 Registered 18 February 2013.",2020,No differences in the change in HRQoL between the groups occurred except for Role Emotional subscale with a larger increase in the HIT arm.,"['de novo recipients', 'Seventy-eight participants completed the intervention', 'de novo heart transplant recipients ']","['high-intensity interval training (HIT', 'High-intensity interval training', 'MICT', 'HIT or MICT', 'moderate intensity continuous training (MICT', 'HIT vs. MICT']","['health-related quality of life (HRQoL', 'physical function scores of HRQoL. Mental health scores', 'VO 2peak  and muscle strength', 'HRQoL', 'general health and well-being on a numeric visual analogue scale', 'Short Form-36 version 2 (SF-36v2) and the Hospital Anxiety and Depression Scale', 'SF-36 scores and VO 2peak', 'physical SF-36v2', 'Role Emotional subscale']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}]",81.0,0.0986644,No differences in the change in HRQoL between the groups occurred except for Role Emotional subscale with a larger increase in the HIT arm.,"[{'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Rolid', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway. katrine.rolid@medisin.uio.no.'}, {'ForeName': 'Arne K', 'Initials': 'AK', 'LastName': 'Andreassen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Yardley', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Gude', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bjørkelund', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Authen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Ingelin', 'Initials': 'I', 'LastName': 'Grov', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Kjell I', 'Initials': 'KI', 'LastName': 'Pettersen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Dall', 'Affiliation': 'Department of Cardiology, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kristjan', 'Initials': 'K', 'LastName': 'Karason', 'Affiliation': 'Transplant Institute, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Kaspar', 'Initials': 'K', 'LastName': 'Broch', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Nytrøen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Rikshospitalet, , PO Box 4950 Nydalen, N-0424, Oslo, Norway.'}]",Health and quality of life outcomes,['10.1186/s12955-020-01536-4']
2428,32807194,Effects of the KEIGAAF intervention on the BMI z-score and energy balance-related behaviors of primary school-aged children.,"The aim of the current study was to evaluate the one- and two-year effectiveness of the KEIGAAF intervention, a school-based mutual adaptation intervention, on the BMI z-score (primary outcome), and energy balance-related behaviors (secondary outcomes) of children aged 7-10 years.A quasi-experimental study was conducted including eight intervention schools and three control schools located in low socioeconomic neighborhoods in the Netherlands. Baseline measurements were conducted in March and April 2017 and repeated after one and 2 years. Data were collected on children's BMI z-score, sedentary behavior (SB), physical activity (PA) behavior, and nutrition behavior through the use of anthropometric measurements, accelerometers, and questionnaires, respectively. All data were supplemented with demographics, and weather conditions data was added to the PA data. Based on the comprehensiveness of implemented physical activities, intervention schools were divided into schools having a comprehensive PA approach and schools having a less comprehensive approach. Intervention effects on continuous outcomes were analyzed using multiple linear mixed models and on binary outcome measures using generalized estimating equations. Intervention and control schools were compared, as well as comprehensive PA schools, less comprehensive PA schools, and control schools. Effect sizes (Cohen's d) were calculated.In total, 523 children participated. Children were on average 8.5 years old and 54% were girls. After 2 years, intervention children's BMI z-score decreased (B = -0.05, 95% CI -0.11;0.01) significantly compared to the control group (B = 0.20, 95% CI 0.09;0.31). Additionally, the intervention prevented an age-related decline in moderate-to-vigorous PA (MVPA) (%MVPA: B = 0.95, 95% CI 0.13;1.76). Negative intervention effects were seen on sugar-sweetened beverages and water consumption at school, due to larger favorable changes in the control group compared to the intervention group. After 2 years, the comprehensive PA schools showed more favorable effects on BMI z-score, SB, and MVPA compared to the other two conditions.This study shows that the KEIGAAF intervention is effective in improving children's MVPA during school days and BMI z-score, especially in vulnerable children. Additionally, we advocate the implementation of a comprehensive approach to promote a healthy weight status, to stimulate children's PA levels, and to prevent children from spending excessive time on sedentary behaviors.Trial registrationNetherlands Trial Register, NTR6716 ( NL6528 ), Registered 27 June 2017 - retrospectively registered.",2020,"After 2 years, the comprehensive PA schools showed more favorable effects on BMI z-score, SB, and MVPA compared to the other two conditions.","['Children were on average 8.5\u2009years old and 54% were girls', 'primary school-aged children', 'NTR6716 ( NL6528 ), Registered 27 June 2017 - retrospectively registered', 'children aged 7-10\u2009years', '523 children participated', 'eight intervention schools and three control schools located in low socioeconomic neighborhoods in the Netherlands']","['KEIGAAF intervention, a school-based mutual adaptation intervention', 'KEIGAAF intervention']","[""children's BMI z-score, sedentary behavior (SB), physical activity (PA) behavior, and nutrition behavior"", ""intervention children's BMI z-score"", 'BMI z-score and energy balance-related behaviors', 'BMI z-score, SB, and MVPA', 'moderate-to-vigorous PA (MVPA', 'BMI z-score (primary outcome), and energy balance-related behaviors']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",523.0,0.0178603,"After 2 years, the comprehensive PA schools showed more favorable effects on BMI z-score, SB, and MVPA compared to the other two conditions.","[{'ForeName': 'Sacha R B', 'Initials': 'SRB', 'LastName': 'Verjans-Janssen', 'Affiliation': 'Department of Health Promotion, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, 6229, HA, Maastricht, The Netherlands. s.verjans@maastrichtuniversity.nl.'}, {'ForeName': 'Sanne M P L', 'Initials': 'SMPL', 'LastName': 'Gerards', 'Affiliation': 'Department of Health Promotion, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, 6229, HA, Maastricht, The Netherlands.'}, {'ForeName': 'Stef P J', 'Initials': 'SPJ', 'LastName': 'Kremers', 'Affiliation': 'Department of Health Promotion, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, 6229, HA, Maastricht, The Netherlands.'}, {'ForeName': 'Steven B', 'Initials': 'SB', 'LastName': 'Vos', 'Affiliation': 'Department of Industrial Design, Eindhoven University of Technology, 5612, AZ, Eindhoven, The Netherlands.'}, {'ForeName': 'Maria W J', 'Initials': 'MWJ', 'LastName': 'Jansen', 'Affiliation': 'Academic Collaborative Center for Public Health, Public Health Service South-Limburg, 6400, AA, Heerlen, The Netherlands.'}, {'ForeName': 'Dave H H', 'Initials': 'DHH', 'LastName': 'Van Kann', 'Affiliation': 'Department of Health Promotion, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University, 6229, HA, Maastricht, The Netherlands.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-01012-8']
2429,32807208,The efficacy of ball blankets on insomnia in depression in outpatient clinics: study protocol for a randomized crossover multicentre trial.,"BACKGROUND


Depression affects approx. 4% of the global population and is often accompanied by insomnia. Medications used to treat insomnia can have side effects such as development of tolerance and addiction. The Protac Ball Blanket™ (PBB) is a non-pharmacological supplement to sedatives and hypnotics, but evidence for the efficacy of PBB is needed before the treatment is implemented. The objective of this trial is to test the efficacy of PBB on insomnia caused by depression in a randomized controlled design.
METHODS


This study is a multicentre, randomized crossover trial with planned inclusion of 45 patients. The randomization procedure is permuted-block randomization with varying block sizes. Patients are allocated into either a sequence ""AB"" or ""BA"" each lasting 4 weeks (28 nights). Patients randomized to the ""AB"" sequence receive treatment A (Protac Ball Blanket™) in the first 2 weeks and switch to treatment B (treatment as usual) in the second period, whereas patients who are randomized to the BA sequence receive treatment B in the first period and treatment A in the second period. The participants will serve as their own control in this design. The primary outcome is changes in total sleep time. Secondary outcome measures are changes in sleep onset latency, number of awakenings, wake after sleep onset, and use of sedatives and hypnotics. Furthermore, quality of sleep, insomnia severity status, and self-reported symptoms of depression, anxiety, interpersonal sensitivity, and neurasthenia will be measured. A paired, two-sided t test to compare the means of the differences in the outcomes will be performed.
DISCUSSION


This clinical trial will assess the effect of PBB on depression-related insomnia. The outcomes are of high interest as the PBB is a potential non-pharmacological supplement to medical treatment of patients with insomnia due to depression.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT03730974 . Registered on 5 November 2018.",2020,"Patients are allocated into either a sequence ""AB"" or ""BA"" each lasting 4 weeks (28 nights).","['patients with insomnia due to depression', '45 patients', 'insomnia in depression in outpatient clinics']","['PBB', 'ball blankets', 'Protac Ball Blanket™ (PBB']","['depression-related insomnia', 'changes in sleep onset latency, number of awakenings, wake after sleep onset, and use of sedatives and hypnotics', 'Furthermore, quality of sleep, insomnia severity status, and self-reported symptoms of depression, anxiety, interpersonal sensitivity, and neurasthenia', 'total sleep time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C2004558', 'cui_str': 'Protac'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0179330', 'cui_str': 'Blanket'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0020592', 'cui_str': 'HYPNOTICS AND SEDATIVES'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0027804', 'cui_str': 'Neurasthenia'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.103601,"Patients are allocated into either a sequence ""AB"" or ""BA"" each lasting 4 weeks (28 nights).","[{'ForeName': 'Sanne Toft', 'Initials': 'ST', 'LastName': 'Kristiansen', 'Affiliation': 'Research Unit of Nursing and Healthcare, Department of Public Health, Aarhus University, Bartholins Allé 2, Aarhus C and Protac A/S, Niels Bohrs Vej 31D, 8660, Skanderborg, Denmark. stk@clin.au.dk.'}, {'ForeName': 'Poul', 'Initials': 'P', 'LastName': 'Videbech', 'Affiliation': 'Center for Neuropsychiatric Depression Research, Mental Health Centre Glostrup, Glostrup, Denmark.'}, {'ForeName': 'Merete Bender', 'Initials': 'MB', 'LastName': 'Bjerrum', 'Affiliation': 'Research Unit of Nursing and Healthcare, Department of Public Health, Aarhus University, Bartholins Allé 2, Aarhus C, Denmark.'}, {'ForeName': 'Erik Roj', 'Initials': 'ER', 'LastName': 'Larsen', 'Affiliation': 'Mental Health Department Odense - University Clinic, Mental Health Service, Odense, Region of Southern Denmark, Denmark.'}]",Trials,['10.1186/s13063-020-04638-y']
2430,32807209,A multi-centre open-label two-arm randomised superiority clinical trial of azithromycin versus usual care in ambulatory COVID-19: study protocol for the ATOMIC2 trial.,"BACKGROUND


Azithromycin is an orally active synthetic macrolide antibiotic with a wide range of anti-bacterial, anti-inflammatory and antiviral properties. It is a safe, inexpensive, generic licenced drug available worldwide and manufactured to scale and is a potential candidate therapy for pandemic coronavirus disease 2019 (COVID-19). Azithromycin was widely used to treat severe SARS-CoV and MERS-CoV, but to date, no randomised data are available in any coronavirus infections. Other ongoing trials are exploring short courses of azithromycin either in early disease, within the first 7 days of symptoms, when azithromycin's antiviral properties may be important, or late in disease when anti-bacterial properties may reduce the risk of secondary bacterial infection. However, the molecule's anti-inflammatory properties, including suppression of pulmonary macrophage-derived pro-inflammatory cytokines such as interleukins-1β, -6, -8, and -18 and cytokines G-CSF and GM-CSF may provide a distinct therapeutic benefit if given in as a prolonged course during the period of progression from moderate to severe disease.
METHODS


ATOMIC2 is a phase II/III, multi-centre, prospective, open-label, two-arm randomised superiority clinical trial of azithromycin versus standard care for adults presenting to hospital with COVID-19 symptoms who are not admitted at initial presentation. We will enrol adults, ≥ 18 years of age assessed in acute hospitals in the UK with clinical diagnosis of COVID-19 infection where management on an ambulatory care pathway is deemed appropriate. Participants will be randomised in a 1:1 ratio to usual care or to azithromycin 500 mg orally daily for 14 days with telephone follow-up at days 14 and 28. The primary objective is to compare the proportion with either death or respiratory failure requiring invasive or non-invasive mechanical ventilation over 28 days from randomisation. Secondary objectives include mortality/respiratory failure in those with a PCR-confirmed diagnosis; all-cause mortality; progression to pneumonia; progression to severe pneumonia; peak severity of illness and mechanistic analysis of blood and nasal biomarkers.
DISCUSSION


This trial will determine the clinical utility of azithromycin in patients with moderately severe, clinically diagnosed COVID-19 and could be rapidly applicable worldwide.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04381962 . Registered on 11 May 2020. EudraCT identifier 2020-001740-26 . Opened for accrual on 29 May 2020.",2020,"It is a safe, inexpensive, generic licenced drug available worldwide and manufactured to scale and is a potential candidate therapy for pandemic coronavirus disease 2019 (COVID-19).","['adults presenting to hospital with COVID-19 symptoms who are not admitted at initial presentation', 'enrol adults, ≥\u200918\u2009years of age assessed in acute hospitals in the UK with clinical diagnosis of COVID-19 infection where management on an ambulatory care pathway is deemed appropriate', 'ambulatory COVID-19', 'patients with moderately severe']","['azithromycin', 'Azithromycin', 'invasive or non-invasive mechanical ventilation']","['proportion with either death or respiratory failure', 'mortality/respiratory failure in those with a PCR-confirmed diagnosis; all-cause mortality; progression to pneumonia; progression to severe pneumonia; peak severity of illness and mechanistic analysis of blood and nasal biomarkers']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0449976', 'cui_str': 'Initial presentation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.197629,"It is a safe, inexpensive, generic licenced drug available worldwide and manufactured to scale and is a potential candidate therapy for pandemic coronavirus disease 2019 (COVID-19).","[{'ForeName': 'Timothy S C', 'Initials': 'TSC', 'LastName': 'Hinks', 'Affiliation': 'Respiratory Medicine Unit and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC), Nuffield Department of Medicine Experimental Medicine, University of Oxford, Oxfordshire, OX3 9DU, UK. timothy.hinks@ndm.ox.ac.uk.'}, {'ForeName': 'Vicki S', 'Initials': 'VS', 'LastName': 'Barber', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Black', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Maisha', 'Initials': 'M', 'LastName': 'Jabeen', 'Affiliation': 'Respiratory Medicine Unit and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC), Nuffield Department of Medicine Experimental Medicine, University of Oxford, Oxfordshire, OX3 9DU, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Melhorn', 'Affiliation': 'University Hospital Llandough, Cardiff, CF64 2XX, UK.'}, {'ForeName': 'Najib M', 'Initials': 'NM', 'LastName': 'Rahman', 'Affiliation': 'Respiratory Medicine Unit and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC), Nuffield Department of Medicine Experimental Medicine, University of Oxford, Oxfordshire, OX3 9DU, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Richards', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lasserson', 'Affiliation': 'Nuffield Department of Medicine, Oxford University, Oxford, UK.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Pavord', 'Affiliation': 'Respiratory Medicine Unit and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC), Nuffield Department of Medicine Experimental Medicine, University of Oxford, Oxfordshire, OX3 9DU, UK.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Bafadhel', 'Affiliation': 'Respiratory Medicine Unit and National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC), Nuffield Department of Medicine Experimental Medicine, University of Oxford, Oxfordshire, OX3 9DU, UK.'}]",Trials,['10.1186/s13063-020-04593-8']
2431,32807214,"An open-label, randomized, non-inferiority trial of the efficacy and safety of ciprofloxacin versus streptomycin + ciprofloxacin in the treatment of bubonic plague (IMASOY): study protocol for a randomized control trial.","BACKGROUND


Bubonic plague is the primary manifestation of infection with Yersinia pestis, accounting for 90% of all plague cases and with 75% of global cases reported in Madagascar. All drugs in use for treating plague are registered based on experimental data and anecdotal evidence, and no regimen currently recommended is supported by a randomized clinical trial. The IMASOY trial intends to fill this knowledge gap by comparing two 10-day regimens included in the national guidelines in Madagascar. The primary objective of the trial is to test the hypothesis that ciprofloxacin monotherapy is non-inferior to streptomycin followed by ciprofloxacin for the treatment of bubonic plague, thus avoiding the need for injectable, potentially toxic, aminoglycosides.
METHODS


A two-arm parallel-group randomized control trial will be conducted across peripheral health centres in Madagascar in five districts. Males and non-pregnant females of all ages with suspected bubonic or pneumonic plague will be recruited over the course of three plague 'seasons'. The primary endpoint of the trial is to assess the proportion of patients with bubonic plague who have a therapeutic response to treatment (defined as alive, resolution of fever, 25% reduction in the size of measurable buboes, has not received an alternative treatment and no clinical decision to continue antibiotics) as assessed on day 11.
DISCUSSION


If successful, the trial has the potential to inform the standard of care guidelines not just in Madagascar but in other countries afflicted by plague. The trial is currently ongoing and expected to complete recruitment in 2022.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04110340 . Registered on 1 October 2019.",2020,"The primary objective of the trial is to test the hypothesis that ciprofloxacin monotherapy is non-inferior to streptomycin followed by ciprofloxacin for the treatment of bubonic plague, thus avoiding the need for injectable, potentially toxic, aminoglycosides.
","['peripheral health centres in Madagascar in five districts', 'Males and non-pregnant females of all ages with suspected bubonic or pneumonic plague', 'bubonic plague (IMASOY']","['ciprofloxacin versus streptomycin + ciprofloxacin', 'ciprofloxacin monotherapy', 'ciprofloxacin']","['therapeutic response to treatment (defined as alive, resolution of fever']","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0024443', 'cui_str': 'Madagascar'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0524688', 'cui_str': 'Pneumonic plague'}, {'cui': 'C0282312', 'cui_str': 'Bubonic plague'}]","[{'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0038425', 'cui_str': 'Streptomycin'}]","[{'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",,0.206759,"The primary objective of the trial is to test the hypothesis that ciprofloxacin monotherapy is non-inferior to streptomycin followed by ciprofloxacin for the treatment of bubonic plague, thus avoiding the need for injectable, potentially toxic, aminoglycosides.
","[{'ForeName': 'Rindra Vatosoa', 'Initials': 'RV', 'LastName': 'Randremanana', 'Affiliation': 'Institut Pasteur de Madagascar, Antananarivo, Madagascar.'}, {'ForeName': 'Mihaja', 'Initials': 'M', 'LastName': 'Raberahona', 'Affiliation': ""Infectious Diseases Department, University Hospital Joseph Raseta Befelatanana Antananarivo - Centre d'Infectiologie Charles Mérieux, University of Antananarivo, Antananarivo, Madagascar.""}, {'ForeName': 'Mamy Jean de Dieu', 'Initials': 'MJD', 'LastName': 'Randria', 'Affiliation': 'Infectious Diseases Department, University Hospital Joseph Raseta, Antananarivo, Madagascar.'}, {'ForeName': 'Minoarisoa', 'Initials': 'M', 'LastName': 'Rajerison', 'Affiliation': 'Institut Pasteur de Madagascar, Antananarivo, Madagascar.'}, {'ForeName': 'Voahangy', 'Initials': 'V', 'LastName': 'Andrianaivoarimanana', 'Affiliation': 'Institut Pasteur de Madagascar, Antananarivo, Madagascar.'}, {'ForeName': 'Agathe', 'Initials': 'A', 'LastName': 'Legrand', 'Affiliation': 'Institut Pasteur de Madagascar, Antananarivo, Madagascar.'}, {'ForeName': 'Tsinjo Fehizoro', 'Initials': 'TF', 'LastName': 'Rasoanaivo', 'Affiliation': 'Institut Pasteur de Madagascar, Antananarivo, Madagascar.'}, {'ForeName': 'Ravaka', 'Initials': 'R', 'LastName': 'Randriamparany', 'Affiliation': 'Institut Pasteur de Madagascar, Antananarivo, Madagascar.'}, {'ForeName': 'Théodora', 'Initials': 'T', 'LastName': 'Mayouya-Gamana', 'Affiliation': 'Institut Pasteur de Madagascar, Antananarivo, Madagascar.'}, {'ForeName': 'Reziky', 'Initials': 'R', 'LastName': 'Mangahasimbola', 'Affiliation': 'Institut Pasteur de Madagascar, Antananarivo, Madagascar.'}, {'ForeName': 'Josie', 'Initials': 'J', 'LastName': 'Bourner', 'Affiliation': 'University of Oxford, Oxford, UK. josephine.bourner@ndm.ox.ac.uk.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Salam', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Gillesen', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Tansy', 'Initials': 'T', 'LastName': 'Edwards', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Schoenhals', 'Affiliation': 'Institut Pasteur de Madagascar, Antananarivo, Madagascar.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Baril', 'Affiliation': 'Institut Pasteur de Madagascar, Antananarivo, Madagascar.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Horby', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Olliaro', 'Affiliation': 'University of Oxford, Oxford, UK.'}]",Trials,['10.1186/s13063-020-04642-2']
2432,32807219,Robotic-arm assisted medial unicondylar knee arthroplasty versus jig-based unicompartmental knee arthroplasty with navigation control: study protocol for a prospective randomised controlled trial.,"BACKGROUND


There remains a paucity of clinical studies assessing how any differences in accuracy of implant positioning between robotic-arm assisted unicompartmental knee arthroplasty (RO UKA) and conventional jig-based unicompartmental knee arthroplasty (CO UKA) translate to patient satisfaction, functional outcomes, and implant survivorship. The objectives of this study are to compare accuracy of implant positioning, limb alignment, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications in CO UKA versus RO UKA. Computer navigation will be used to assess intraoperative knee kinematics in all patients undergoing CO UKA.
METHODS AND ANALYSIS


This prospective randomised controlled trial will include 140 patients with symptomatic medial compartment knee arthritis undergoing primary UKA. Following informed consent, patients will be randomised to CO UKA (control group) or RO UKA (investigation group) at a ratio of 1:1 using an online random number generator. The primary objective of this study is to compare accuracy of implant positioning in CO UKA versus RO UKA. The secondary objectives are to compare the following outcomes between the two treatment groups: limb alignment, surgical efficiency, postoperative functional rehabilitation, functional outcomes, quality of life, range of motion, resource use, cost effectivness, and complications. Observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes pertaining to these objectives. Ethical approval was obtained from the London-Bloomsbury Research Ethics Committee, UK. The study is sponsored by University College London, UK.
DISCUSSION


This study compares a comprehensive and robust range of clinical, functional, and radiological outcomes in CO UKA versus RO UKA. The findings of this study will provide an improved understanding of the differences in CO UKA versus RO UKA with respect to accuracy of implant positioning, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04095637 . Registered on 19 September 2019.",2020,"The findings of this study will provide an improved understanding of the differences in CO UKA versus RO UKA with respect to accuracy of implant positioning, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications.
","['patients undergoing CO UKA', '140 patients with symptomatic medial compartment knee arthritis undergoing primary UKA', 'University College London, UK']","['CO UKA versus RO UKA', 'Robotic-arm assisted medial unicondylar knee arthroplasty versus jig-based unicompartmental knee arthroplasty with navigation control', 'robotic-arm assisted unicompartmental knee arthroplasty (RO UKA) and conventional jig-based unicompartmental knee arthroplasty (CO UKA', 'CO UKA (control group) or RO UKA', 'Computer navigation']","['intraoperative knee kinematics', 'accuracy of implant positioning, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications', 'limb alignment, surgical efficiency, postoperative functional rehabilitation, functional outcomes, quality of life, range of motion,\xa0resource use, cost effectivness, and complications', 'accuracy of implant positioning, limb alignment, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications in CO UKA versus RO UKA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0447798', 'cui_str': 'Compartment of knee'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0336542', 'cui_str': 'Robotic arm'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009622', 'cui_str': 'Computer'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0454532', 'cui_str': 'Functional rehabilitation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0864243', 'cui_str': 'Unicompartmental Knee Arthroplasty'}, {'cui': 'C0336542', 'cui_str': 'Robotic arm'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]",140.0,0.151386,"The findings of this study will provide an improved understanding of the differences in CO UKA versus RO UKA with respect to accuracy of implant positioning, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications.
","[{'ForeName': 'Babar', 'Initials': 'B', 'LastName': 'Kayani', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK. babar.kayani@gmail.com.'}, {'ForeName': 'Sujith', 'Initials': 'S', 'LastName': 'Konan', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Tahmassebi', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Ayuob', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Moriarty', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}, {'ForeName': 'Fares S', 'Initials': 'FS', 'LastName': 'Haddad', 'Affiliation': 'Department of Trauma and Orthopaedic Surgery, University College Hospital, 235 Euston Road, Fitzrovia, London, NW1 2BU, UK.'}]",Trials,['10.1186/s13063-020-04631-5']
2433,32807229,Integrative medicine rehabilitation for children with cerebral palsy: a study protocol for a multicenter pragmatic randomized controlled trial.,"BACKGROUND


Traditional Korean medicine (TKM) has been employed for the treatment of children with cerebral palsy in Korea; however, the addition of TKM to usual rehabilitation (UR) treatment is hindered by insufficient evidence of clinical improvement with TKM in patients with cerebral palsy. In this study, we will evaluate the effectiveness and safety of integrative medicine rehabilitation (IMR) for cerebral palsy through a randomized controlled clinical study.
METHODS


Eighty children (2-6 years old) diagnosed with cerebral palsy will be recruited and randomly divided into groups A and B. Patients in group A will receive IMR with UR, while those in group B will receive only UR during weeks 1-12 of the study. IMR includes acupuncture treatment (head and limb acupuncture) three times a week and the administration of herbal medicine (Yukgunza-tang and Yukmijihwang-tang extracts) twice a day in parallel with UR. Evaluations will be conducted at the beginning of the study and at 12 and 24 weeks (follow-up). The primary outcome is the Gross Motor Function Measure-88 score, and the secondary outcomes are the scores for the Goal Attainment Scale, Korean Bayley Scales of Infant Development III, and the Pediatric Quality of Life Inventory, and adverse events.
DISCUSSION


This will be the first pragmatic randomized controlled trial to evaluate the efficacy and safety of IMR in children with cerebral palsy in Korea. The results will help to demonstrate if IMR is an effective therapeutic approach for cerebral palsy.
TRIAL REGISTRATION


Ministry of Food and Drug Safety 31361 ( http://www.mfds.go.kr ). Registered on 29 June 2017. Clinical Research Information Service KCT0002620 ( https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=9819 ). Registered on 29 December 2017.",2020,This will be the first pragmatic randomized controlled trial to evaluate the efficacy and safety of IMR in children with cerebral palsy in Korea.,"['children with cerebral palsy in Korea', 'cerebral palsy', 'patients with cerebral palsy', 'children with cerebral palsy', 'Eighty children (2-6\u2009years old) diagnosed with cerebral palsy']","['IMR with UR', 'IMR', 'Traditional Korean medicine (TKM', 'herbal medicine (Yukgunza-tang and Yukmijihwang-tang extracts', 'Integrative medicine rehabilitation', 'integrative medicine rehabilitation (IMR']","['Gross Motor Function Measure-88 score, and the secondary outcomes are the scores for the Goal Attainment Scale, Korean Bayley Scales of Infant Development III, and the Pediatric Quality of Life Inventory, and adverse events']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C2350258', 'cui_str': 'Integrative Medicine'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}, {'cui': 'C3851808', 'cui_str': 'yukmijihwang-tang'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}]","[{'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",80.0,0.113522,This will be the first pragmatic randomized controlled trial to evaluate the efficacy and safety of IMR in children with cerebral palsy in Korea.,"[{'ForeName': 'Mi-Joo', 'Initials': 'MJ', 'LastName': 'Lee', 'Affiliation': 'Department of Korean Gynecology, CHA Bundang Medical Center, CHA University, Seongnam-si, Gyeonggi-Do, South Korea.'}, {'ForeName': 'Young-Ju', 'Initials': 'YJ', 'LastName': 'Yun', 'Affiliation': 'Department of Integrative Medicine, School of Korean Medicine, Pusan National University, 20, Geumo-ro Mulgeum-eup, Yangsan-si Gyeongsangnam-do, 50612, Pusan, Republic of Korea. mdkmdyun@pusan.ac.kr.'}, {'ForeName': 'Sun-Ae', 'Initials': 'SA', 'LastName': 'Yu', 'Affiliation': 'Department of Pediatrics, College of Korean Medicine, Dong-Eui University, Pusan, South Korea.'}, {'ForeName': 'Yong-Beom', 'Initials': 'YB', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Pusan, South Korea.'}, {'ForeName': 'Soo-Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Rehabilitation Medicine, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan, South Korea.'}, {'ForeName': 'Jun-Hee', 'Initials': 'JH', 'LastName': 'Han', 'Affiliation': 'Department of Statistics & Institute of Statistics, Hallym University, Chuncheon, South Korea.'}]",Trials,['10.1186/s13063-020-04639-x']
2434,32807234,"Prednisone for patients with recurrent implantation failure: study protocol for a double-blind, multicenter, randomized, placebo-controlled trial.","BACKGROUND


Recurrent implantation failure (RIF) brings great challenges to clinicians and causes deep frustration to patients. Previous data has suggested that prednisone may play a promising role in the establishment of pregnancy and help improve the pregnancy outcome in women with RIF. But there is insufficient evidence from randomized clinical trials that had adequate power to determine if prednisone can enhance live births as the primary outcome.
METHODS/DESIGN


This trial is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial (1:1 ratio of prednisone versus placebo). Infertile patients with RIF who intend to undergo frozen-thawed embryo transfer (FET) after in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) or pre-implantation genetic testing for aneuploidy (PGT-A) will be enrolled and randomly assigned to two parallel groups. Participants will be given the treatment of prednisone or placebo from the start of endometrial preparation till the end of the first trimester of pregnancy if pregnant. The primary outcome is live birth rate.
DISCUSSION


The results of this study will provide evidence for the effect of prednisone on pregnancy outcomes in patients with RIF.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1800018783 . Registered on 9 October 2018.",2020,Previous data has suggested that prednisone may play a promising role in the establishment of pregnancy and help improve the pregnancy outcome in women with RIF.,"['Infertile patients with RIF who intend to undergo', 'patients with RIF', 'women with RIF', 'patients with recurrent implantation failure']","['Prednisone', 'prednisone', 'prednisone versus placebo', 'prednisone or placebo', 'frozen-thawed embryo transfer (FET) after in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) or pre-implantation genetic testing for aneuploidy (PGT-A', 'placebo']","['pregnancy outcomes', 'live birth rate']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0679560', 'cui_str': 'Genetic test'}, {'cui': 'C0002938', 'cui_str': 'Aneuploidy'}]","[{'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]",,0.822378,Previous data has suggested that prednisone may play a promising role in the establishment of pregnancy and help improve the pregnancy outcome in women with RIF.,"[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Center for Reproductive Medicine, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200135, China.'}, {'ForeName': 'Junhao', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Center for Reproductive Medicine, Shandong Provincial Hospital Affiliated to Shandong University, Key Laboratory of Reproductive Endocrinology, Shandong University, Ministry of Education, and National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Jinan, China.'}, {'ForeName': 'Jiayin', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Center of Clinical Reproductive Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Jichun', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'Reproductive Medical Center, Obstetrics and Gynecology Department, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Center for Reproductive Medicine, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200135, China.'}, {'ForeName': 'Daimin', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': 'Center for Reproductive Medicine, Shandong Provincial Hospital Affiliated to Shandong University, Key Laboratory of Reproductive Endocrinology, Shandong University, Ministry of Education, and National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Jinan, China.'}, {'ForeName': 'Zi-Jiang', 'Initials': 'ZJ', 'LastName': 'Chen', 'Affiliation': 'Center for Reproductive Medicine, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200135, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Center for Reproductive Medicine, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, 200135, China. syun163@163.com.'}]",Trials,['10.1186/s13063-020-04630-6']
2435,32807403,Effect of crystalline phase assemblage on reliability of 3Y-TZP.,"STATEMENT OF PROBLEM


Strengthening mechanisms of zirconia ceramics stabilized with 3 mol% yttria (3Y-TZP) are complex and dictated by the crystalline phase assemblage. Although their clinical performance for dental restorations has been excellent, there is evidence that framework fractures do occur and have been underreported. Meanwhile, the relationship between phase assemblage and reliability of 3Y-TZP is not properly understood.
PURPOSE


The purpose of this in vitro study was to elucidate the relationship between crystalline phase assemblage and the reliability of 3Y-TZP and to calculate the associated probabilities of survival.
MATERIAL AND METHODS


Disks of 3Y-TZP were prepared from cylindrical blanks and randomly assigned to 12 experimental groups (n=20 per group). Different crystalline phase assemblages were produced by either varying the sintering temperature from 1350 °C to 1600 °C and/or treating the surface by airborne-particle abrasion with 50-mm alumina particles at a pressure of 0.2 MPa for 1 minute with or without subsequent heat treatment. Crystalline phases were analyzed by standard and grazing incidence X-ray diffraction (GIXRD). The relationship between phase assemblage and reliability was determined by measuring the biaxial flexural strength (BFS) according to ISO standard 6872 and by using Weibull statistics to calculate the Weibull modulus (m), probability of survival, and maximum allowable stresses. XRD results were analyzed by ANOVA to detect statistically significant differences between groups. Adjustment for all pairwise group comparisons was made using the Tukey method (α=.05).
RESULTS


Standard incidence XRD confirmed the presence of a small amount of cubic phase after sintering at 1350 °C. A cubic-derived nontransformable tetragonal t'-phase was observed at sintering temperatures of 1450 °C and above, the amount of which increased linearly. GIXRD revealed that airborne-particle abraded groups sintered at 1350 °C and 1600 °C had the highest variability in monoclinic phase fraction as a function of depth. These groups were also associated with the lowest reliability. Groups as-sintered at 1350 °C and 1600 °C had the lowest modulus (m=8.1 [0.5] and 7.0 [0.8], respectively) and probability of survival (Ps) for a maximum allowable stress of 700 MPa, while treated groups sintered at 1450 °C and 1550 °C were associated with the highest modulus (from 15.0 [1.4] to 20.9 [1.4]) and Ps (≥0.9999). The lower strength and reliability of groups sintered at 1600 °C was consistent with the presence of a significant amount of nontransformable t'-phase. The pattern of BFS results indicated that ferro-elastic domain switching was a dominant strengthening mechanism in 3Y-TZP.
CONCLUSIONS


The present study first reported on the detrimental effect of the cubic-derived nontransformable t'-phase on the mechanical properties of 3Y-TZP. It was demonstrated that phase assemblage determined reliability and was directly linked to the probability of survival.",2020,"Groups as-sintered at 1350 °C and 1600 °C had the lowest modulus (m=8.1 [0.5] and 7.0 [0.8], respectively) and probability of survival (Ps) for a maximum allowable stress of 700 MPa, while treated groups sintered at 1450 °C and 1550",['Disks of 3Y-TZP were prepared from cylindrical blanks and randomly assigned to 12 experimental groups (n=20 per group'],[],"['probability of survival', 'probability of survival (Ps', 'biaxial flexural strength (BFS', 'GIXRD', 'lower strength and reliability']","[{'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0205114', 'cui_str': 'Cylindrical'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4704755', 'cui_str': 'Fracture Strength'}, {'cui': 'C1302752', 'cui_str': 'Abrasion'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0043301', 'cui_str': 'Xray Diffraction'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",,0.0269623,"Groups as-sintered at 1350 °C and 1600 °C had the lowest modulus (m=8.1 [0.5] and 7.0 [0.8], respectively) and probability of survival (Ps) for a maximum allowable stress of 700 MPa, while treated groups sintered at 1450 °C and 1550","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Denry', 'Affiliation': 'Professor, Iowa Institute for Oral Health Research, University of Iowa College of Dentistry and Department of Prosthodontics, Iowa City, Iowa. Electronic address: Isabelle-Denry@uiowa.edu.'}, {'ForeName': 'Maged', 'Initials': 'M', 'LastName': 'Abdelaal', 'Affiliation': 'Clinical Assistant Professor, Division of Prosthodontics, Department of General Dentistry, East Carolina University School of Dental Medicine, Greenville, N.C.'}, {'ForeName': 'Deborah V', 'Initials': 'DV', 'LastName': 'Dawson', 'Affiliation': 'Professor, Department of Biostatistics, University of Iowa College of Public Health, Iowa City, Iowa.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Holloway', 'Affiliation': 'Professor and Head, Department of Prosthodontics, University of Iowa College of Dentistry, Iowa City, Iowa.'}, {'ForeName': 'John Robert', 'Initials': 'JR', 'LastName': 'Kelly', 'Affiliation': 'Professor, Department of Reconstructive Sciences, University of Connecticut Health Center, Farmington, Conn.'}]",The Journal of prosthetic dentistry,['10.1016/j.prosdent.2020.05.023']
2436,32807435,Effect of Informational Support on Anxiety in Family Caregivers of Patients with Hemiplegic Stroke.,"BACKGROUND


Brain stroke causes physical and mental disabilities, as well as dependence on one's family. In such cases, the families suffer from severe crisis and anxiety due to the unexpected incidence of the disease and unawareness of the associated consequences.
OBJECTIVES


The aim of the present study was to evaluate the effectiveness of informational support on the level of anxiety in family caregivers of hemiplegic stroke patients.
METHODS


This quasi-experimental study was performed on 78 family caregivers of hemiplegic stroke patients admitted to the Neurology Department of Farshchian Hospital in Hamadan, Iran, over 8 months. The subjects were selected through convenience sampling method and divided into two groups of intervention (n = 40) and control (n = 38). Intervention started from the third day of hospitalization and continued until the eleventh day. During this period, information about the ward, equipment, patient status, and care procedure at home, was provided for the intervention group individually and in groups. On the other hand, the control group only received the routine care. Anxiety level of caregivers was measured through the Spielberger scale both before and after the intervention. Data analysis was performed in SPSS software (version 16).
RESULTS


Based on the results, both groups were similar in terms of demographic variables (P > 0.05). Moreover, there was no significant difference between the two groups regarding the mean level of state and trait anxiety before the intervention (P > 0.05). However, after intervention, the mean level of state and trait anxiety of the intervention group showed a significant reduction in comparison to that of the control group (P < 0.05).
CONCLUSIONS


According to the findings, it can be concluded that informational support is effective in reducing the state and trait anxiety in family caregivers of stroke patients. Therefore, it is suggested that nurses consider informational support as an important nursing intervention during hospitalization.",2020,"Moreover, there was no significant difference between the two groups regarding the mean level of state and trait anxiety before the intervention (P > 0.05).","['family caregivers of hemiplegic stroke patients', 'family caregivers of stroke patients', '78 family caregivers of hemiplegic stroke patients admitted to the Neurology Department of Farshchian Hospital in Hamadan, Iran, over 8 months', 'Family Caregivers of Patients with Hemiplegic Stroke']","['Informational Support', 'informational support']","['Anxiety level of caregivers', 'state and trait anxiety', 'mean level of state and trait anxiety']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587475', 'cui_str': 'Neurology department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",78.0,0.0165505,"Moreover, there was no significant difference between the two groups regarding the mean level of state and trait anxiety before the intervention (P > 0.05).","[{'ForeName': 'Azim', 'Initials': 'A', 'LastName': 'Azizi', 'Affiliation': 'PhD, Assistant Professor, Chronic Diseases (Home Care) Research Centre, Malayer Nursing School, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Khatiban', 'Affiliation': 'PhD, Professor, Mother & Child Care Research Center. Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Zhale', 'Initials': 'Z', 'LastName': 'Mollai', 'Affiliation': 'M.Sc in Critical Care Nursing, Student Research Committee, School of Nursing and Midwifery, Hamadan University of Medical Sciences, Hamadan, Iran. Electronic address: zhanet2811@gmail.com.'}, {'ForeName': 'Younes', 'Initials': 'Y', 'LastName': 'Mohammadi', 'Affiliation': 'PhD, Associate Professor, Department of Epidemiology, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105020']
2437,32807447,Pedaling improves gait ability of hemiparetic patients with stiff-knee gait: fall prevention during gait.,"BACKGROUND AND PURPOSE


Stiff-knee gait, which is a gait abnormality observed after stroke, is characterized by decreased knee flexion angles during the swing phase, and it contributes to a decline in gait ability. This study aimed to identify the immediate effects of pedaling exercises on stiff-knee gait from a kinesiophysiological perspective.
METHODS


Twenty-one patients with chronic post-stroke hemiparesis and stiff-knee gait were randomly assigned to a pedaling group and a walking group. An ergometer was set at a load of 5 Nm and rotation speed of 40 rpm, and gait was performed at a comfortable speed; both the groups performed the intervention for 10 min. Kinematic and electromyographical data while walking on flat surfaces were immediately measured before and after the intervention.
RESULTS


In the pedaling group, activity of the rectus femoris significantly decreased from the pre-swing phase to the early swing phase during gait after the intervention. Flexion angles and flexion angular velocities of the knee and hip joints significantly increased during the same period. The pedaling group showed increased step length on the paralyzed side and gait velocity.
CONCLUSIONS


Pedaling increases knee flexion during the swing phase in hemiparetic patients with stiff-knee gait and improves gait ability.",2020,"In the pedaling group, activity of the rectus femoris significantly decreased from the pre-swing phase to the early swing phase during gait after the intervention.","['Twenty-one patients with chronic post-stroke hemiparesis and stiff-knee gait', 'hemiparetic patients with stiff-knee gait']","['pedaling group and a walking group', 'pedaling exercises']","['gait ability', 'activity of the rectus femoris', 'paralyzed side and gait velocity', 'Flexion angles and flexion angular velocities of the knee and hip joints', 'knee flexion', 'step length', 'Kinematic and electromyographical data while walking on flat surfaces', 'knee flexion angles']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0427141', 'cui_str': 'Stiff knee gait'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0522224', 'cui_str': 'Paralysis'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0205148', 'cui_str': 'Surface'}]",21.0,0.0178517,"In the pedaling group, activity of the rectus femoris significantly decreased from the pre-swing phase to the early swing phase during gait after the intervention.","[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Fujita', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Science, Fukui Health Science University, 55-13-1 Egami, Fukui-city 910-3190, Fukui, Japan. Electronic address: k.fujita@fukui-hsu.ac.jp.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Science, Fukui Health Science University, 55-13-1 Egami, Fukui-city 910-3190, Fukui, Japan. Electronic address: yasutaka_k@fukui-hsu.ac.jp.'}, {'ForeName': 'Hiroichi', 'Initials': 'H', 'LastName': 'Miaki', 'Affiliation': 'Faculty of Health Sciences, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University, Kanazawa-city, Ishikawa, Japan. Electronic address: miaki@mhs.mp.kanazawa-u.ac.jp.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Hori', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Science, Fukui Health Science University, 55-13-1 Egami, Fukui-city 910-3190, Fukui, Japan. Electronic address: rpt-hori@fukui-hsu.ac.jp.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Tsushima', 'Affiliation': 'Department of Physical Therapy Rehabilitation, Fukui General Hospital, Fukui-city, Fukui, Japan. Electronic address: yuuichi1685@yahoo.co.jp.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Sakai', 'Affiliation': 'Department of Rehabilitation, Faculty of Health Science, Fukui Health Science University, 55-13-1 Egami, Fukui-city 910-3190, Fukui, Japan. Electronic address: r-sakai@fukui-hsu.ac.jp.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Nomura', 'Affiliation': 'Department of Physical Therapy Rehabilitation, Fukui General Hospital, Fukui-city, Fukui, Japan. Electronic address: tomomi3222@yahoo.co.jp.'}, {'ForeName': 'Tomoki', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Department of Physical Therapy Rehabilitation, Fukui General Hospital, Fukui-city, Fukui, Japan. Electronic address: hal.ntsl.pal@hotmail.co.jp.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Physical Therapy Rehabilitation, Fukui General Hospital, Fukui-city, Fukui, Japan. Electronic address: hiro-kino@kj.ttn.ne.jp.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Nishida', 'Affiliation': 'Department of Physical Therapy Rehabilitation, Fukui General Hospital, Fukui-city, Fukui, Japan. Electronic address: fsmsc@f-gh.jp.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Hitosugi', 'Affiliation': 'Department of Legal Medicine, Shiga University of Medical Science, Otsu-city, Shiga, Japan. Electronic address: hitosugi@belle.shiga-med.ac.jp.'}]",Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association,['10.1016/j.jstrokecerebrovasdis.2020.105035']
2438,32807537,Prospective Randomized Trial of Standard Left Anterolateral Thoracotomy Versus Modified Bilateral Clamshell Thoracotomy Performed by Emergency Physicians.,"STUDY OBJECTIVE


Resuscitative thoracotomy is a time-sensitive, lifesaving procedure that may be performed by emergency physicians. The left anterolateral thoracotomy (LAT) is the standard technique commonly used in the United States to gain rapid access to critical intrathoracic structures. However, the smaller incision and subsequent limited exposure may not be optimal for the nonsurgical specialist to complete time-sensitive interventions. The modified bilateral anterior clamshell thoracotomy (MCT) developed by Barts Health NHS Trust clinicians at London's Air Ambulance overcomes these inherent difficulties, maximizes thoracic cavity visualization, and may be the ideal technique for the nonsurgical specialist. The aim of this study is to identify the optimal technique for the nonsurgical-specialist-performed resuscitative thoracotomy. Secondary aims of the study are to identify technical difficulties, procedural concerns, and physician preferences.
METHODS


Emergency medicine staff and senior resident physicians were recruited from an academic Level I trauma center. Subjects underwent novel standardized didactic and skills-specific training on both the MCT and LAT techniques. Later, subjects were randomized to the order of intervention and performed both techniques on separate fresh, nonfrozen human cadaver specimens. Success was determined by a board-certified surgeon and defined as complete delivery of the heart from the pericardial sac and subsequent 100% occlusion of the descending thoracic aorta with a vascular clamp. The primary outcome was time to successful completion of the resuscitative thoracotomy technique. Secondary outcomes included successful exposure of the heart, successful descending thoracic aortic cross clamping, successful procedural completion, time to exposure of the heart, time to descending thoracic aortic cross-clamp placement, number and type of iatrogenic injuries, correct anatomic structure identification, and poststudy participant questionnaire.
RESULTS


Sixteen emergency physicians were recruited; 15 met inclusion criteria. All participants were either emergency medicine resident (47%) or emergency medicine staff (53%). The median number of previously performed training LATs was 12 (interquartile range 6 to 15) and the median number of previously performed MCTs was 1 (interquartile range 1 to 1). The success rates of our study population for the MCT and LAT techniques were not statistically different (67% versus 40%; difference 27%; 95% confidence interval -61% to 8%). However, staff emergency physicians were significantly more successful with the MCT compared with the LAT (88% versus 25%; difference 63%; 95% CI 9% to 92%). Overall, the MCT also had a significantly higher proportion of injury-free trials compared with the LAT technique (33% versus 0%; difference 33%; 95% CI 57% to 9%). Physician procedure preference favored the MCT over the LAT (87% versus 13%; difference 74%; 95% CI 23% to 97%).
CONCLUSION


Resuscitative thoracotomy success rates were lower than expected in this capable subject population. Success rates and procedural time for the MCT and LAT were similar. However, the MCT had a higher success rate when performed by staff emergency physicians, resulted in less periprocedural iatrogenic injuries, and was the preferred technique by most subjects. The MCT is a potentially feasible alternative resuscitative thoracotomy technique that requires further investigation.",2020,"Physician procedure preference favored the MCT over the LAT (87% versus 13%; difference 74%; 95% CI 23% to 97%).
","['All participants were either emergency medicine resident (47%) or emergency medicine staff (53', 'Emergency medicine staff and senior resident physicians were recruited from an academic Level I trauma center', 'Sixteen emergency physicians were recruited; 15 met inclusion criteria']","['left anterolateral thoracotomy (LAT', 'MCT', 'LAT', 'novel standardized didactic and skills-specific training on both the MCT and LAT techniques', 'modified bilateral anterior clamshell thoracotomy (MCT', 'Standard Left Anterolateral Thoracotomy Versus Modified Bilateral Clamshell Thoracotomy', 'nonsurgical-specialist-performed resuscitative thoracotomy']","['Resuscitative thoracotomy success rates', 'successful exposure of the heart, successful descending thoracic aortic cross clamping, successful procedural completion, time to exposure of the heart, time to descending thoracic aortic cross-clamp placement, number and type of iatrogenic injuries, correct anatomic structure identification, and poststudy participant questionnaire', 'median number of previously performed training LATs', 'time to successful completion of the resuscitative thoracotomy technique', 'periprocedural iatrogenic injuries', 'Success rates and procedural time', 'success rate']","[{'cui': 'C0013964', 'cui_str': 'Emergency medicine'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0442950', 'cui_str': 'Anterolateral thoracotomy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0039991', 'cui_str': 'Chest wall incision'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0854404', 'cui_str': 'Iatrogenic injury'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0700276', 'cui_str': 'Anatomical structure'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023979', 'cui_str': 'Thyroid Stimulator, Long-Acting'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",,0.0563108,"Physician procedure preference favored the MCT over the LAT (87% versus 13%; difference 74%; 95% CI 23% to 97%).
","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Newberry', 'Affiliation': 'United States Army Institute of Surgical Research, Fort Sam Houston, TX; SAUSHEC EMS and Disaster Medicine Fellowship Program, Fort Sam Houston, TX; Uniformed Services University, Department of Military and Emergency Medicine, Bethesda, MD; Barts Health NHS Trust, Royal London Hospital, Whitechapel, London, United Kingdom. Electronic address: ryan.k.newberry.mil@mail.mil.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'SAUSHEC EMS and Disaster Medicine Fellowship Program, Fort Sam Houston, TX.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mitchell', 'Affiliation': 'United States Army Institute of Surgical Research, Fort Sam Houston, TX.'}, {'ForeName': 'Joseph K', 'Initials': 'JK', 'LastName': 'Maddry', 'Affiliation': 'United States Air Force En Route Care Research Center, Fort Sam Houston, TX.'}, {'ForeName': 'Allyson A', 'Initials': 'AA', 'LastName': 'Arana', 'Affiliation': 'United States Air Force En Route Care Research Center, Fort Sam Houston, TX.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Achay', 'Affiliation': 'Centre for Emergency Health Sciences, Spring Branch, TX.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Rahm', 'Affiliation': 'Centre for Emergency Health Sciences, Spring Branch, TX.'}, {'ForeName': 'Brit', 'Initials': 'B', 'LastName': 'Long', 'Affiliation': 'Department of Emergency Medicine, San Antonio Military Medical Center, Fort Sam Houston, TX.'}, {'ForeName': 'Tyson', 'Initials': 'T', 'LastName': 'Becker', 'Affiliation': 'Department of Trauma Surgery, San Antonio Military Medical Center, Fort Sam Houston, TX.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Grier', 'Affiliation': ""Barts Health NHS Trust, Royal London Hospital, Whitechapel, London, United Kingdom; The Institute of Pre-Hospital Care at London's Air Ambulance, Royal London Hospital, Whitechapel, London, United Kingdom.""}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Davies', 'Affiliation': ""Barts Health NHS Trust, Royal London Hospital, Whitechapel, London, United Kingdom; The Institute of Pre-Hospital Care at London's Air Ambulance, Royal London Hospital, Whitechapel, London, United Kingdom.""}]",Annals of emergency medicine,['10.1016/j.annemergmed.2020.05.042']
2439,32811460,Home-based intervention for non-Hispanic black families finds no significant difference in infant size or growth: results from the Mothers & Others randomized controlled trial.,"BACKGROUND


Non-Hispanic black (NHB) infants are twice as likely as non-Hispanic white infants to experience rapid weight gain in the first 6 months, yet few trials have targeted this population. The current study tests the efficacy of ""Mothers & Others,"" a home-based intervention for NHB women and their study partners versus an attention-control, on infant size and growth between birth and 15 months.
METHODS


Mothers & Others was a two-group randomized controlled trial conducted between November 2013 and December 2017 with enrollment at 28-weeks pregnancy and follow-up at 3-, 6-, 9-, 12-, and 15-months postpartum. Eligible women self-identified as NHB, English-speaking, and 18-39 years. The obesity prevention group (OPG) received anticipatory guidance (AG) on responsive feeding and care practices and identified a study partner, who was encouraged to attend home visits. The injury prevention group (IPG) received AG on child safety and IPG partners only completed study assessments. The primary delivery channel for both groups was six home visits by a peer educator (PE). The planned primary outcome was mean weight-for-length z-score. Given significant differences between groups in length-for-age z-scores, infant weight-for-age z-score (WAZ) was used in the current study. A linear mixed model, using an Intent-To-Treat (ITT) data set, tested differences in WAZ trajectories between the two treatment groups. A non-ITT mixed model tested for differences by dose received.
RESULTS


Approximately 1575 women were screened for eligibility and 430 were enrolled. Women were 25.7 ± 5.3 years, mostly single (72.3%), and receiving Medicaid (74.4%). OPG infants demonstrated lower WAZ than IPG infants at all time points, but differences were not statistically significant (WAZ diff  = - 0.07, 95% CI - 0.40 to 0.25, p = 0.659). In non-ITT models, infants in the upper end of the WAZ distribution at birth demonstrated incremental reductions in WAZ for each home visit completed, but the overall test of the interaction was not significant (F 2,170  = 1.41, p = 0.25).
CONCLUSIONS


Despite rich preliminary data and a strong conceptual model, Mothers & Others did not produce significant differences in infant growth. Results suggest a positive impact of peer support in both groups.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT01938118 , 09/10/2013.",2020,"OPG infants demonstrated lower WAZ than IPG infants at all time points, but differences were not statistically significant (WAZ diff  = - 0.07, 95% CI - 0.40 to 0.25, p = 0.659).","['Approximately 1575 women were screened for eligibility and 430 were enrolled', 'Eligible women self-identified as NHB, English-speaking, and 18-39\u2009years', 'Mothers & Others was a two-group randomized controlled trial conducted between November 2013 and December 2017 with enrollment at 28-weeks pregnancy and follow-up at 3-, 6', 'Women were 25.7\u2009±\u20095.3\u2009years, mostly single (72.3%), and receiving Medicaid (74.4']","['injury prevention group (IPG) received AG', 'obesity prevention group (OPG) received anticipatory guidance (AG', 'Home-based intervention']","['infant size or growth', 'mean weight-for-length z-score', 'length-for-age z-scores, infant weight-for-age z-score (WAZ']","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}]","[{'cui': 'C0150638', 'cui_str': 'Preventing injury'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150134', 'cui_str': 'Anticipatory guidance'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",1575.0,0.176378,"OPG infants demonstrated lower WAZ than IPG infants at all time points, but differences were not statistically significant (WAZ diff  = - 0.07, 95% CI - 0.40 to 0.25, p = 0.659).","[{'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Wasser', 'Affiliation': 'Department of Nutrition, University of North Carolina, 135 Dauer Drive, CB# 7400, Chapel Hill, NC, 27599-7400, USA. wasser@email.unc.edu.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Thompson', 'Affiliation': 'Department of Nutrition, University of North Carolina, 135 Dauer Drive, CB# 7400, Chapel Hill, NC, 27599-7400, USA.'}, {'ForeName': 'Chirayath M', 'Initials': 'CM', 'LastName': 'Suchindran', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Barbara D', 'Initials': 'BD', 'LastName': 'Goldman', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Hodges', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Meredith J', 'Initials': 'MJ', 'LastName': 'Heinig', 'Affiliation': 'University of California, Davis, CA, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Bentley', 'Affiliation': 'Department of Nutrition, University of North Carolina, 135 Dauer Drive, CB# 7400, Chapel Hill, NC, 27599-7400, USA.'}]",BMC pediatrics,['10.1186/s12887-020-02273-9']
2440,32811461,Substance P induces sympathetic immune response in the contralateral eye after the first eye cataract surgery in type 2 diabetic patients.,"BACKGROUND


Substance P (SP) is a nociceptive tachykinin which regulates the immune inflammatory reactions including monocyte chemoattractant protein 1 (MCP-1) production. Sequential second-eye cataract surgery patients often suffer more pain than the first one partly because of the MCP-1 increase in aqueous humor (AH). This study aims to illustrate whether SP is involved in sympathetic inflammatory responses in the contralateral eye in patients with or without type 2 diabetes.
METHODS


This prospective randomized clinical study included 51 cataract patients (22 with diabetes and 29 without). Bilateral sequential cataract surgeries were conducted with 1-day or 1-week interval randomly. More than 100 μl of AH were obtained before surgery and stored for later analysis using magnetic Luminex assays to detect interleukin (IL)-1β, IL-1ra,IL-6, IL-8, IL-10, MCP-1, vascular endothelial growth factor, spinal macrophage inflammatory protein (MIP-1a), interferon-inducible protein 10 (IP-10), regulated on activation, normal T expressed and secreted (RANTES), as well as the enzyme-linked immunosorbent assay for SP.
RESULTS


Among the 4 groups, no significant differences were found in age, sex distribution, the R/L ration of the first surgery eye, or the lens nucleus hardness (P ≥ 0.802). Over 100 μl of AH samples were collected safely in all cases without intraoperative complications. SP and MCP-1 levels were both increased significantly in the second eye of the diabetic patients with 1-day and 1-week interval (P ≤ 0.040). The SP increase in the second eye of the diabetic patients were significantly higher than that of the patients without diabetes (P ≤ 0.030) both in the groups with 1-day and 1-week interval. Similarly, the MCP-1 increase was significantly higher in the diabetic patients in the group with 1-week interval (P = 0.042).
CONCLUSIONS


Substance P and MCP-1 productions elevated in the AH of the contralateral eye after the first-eye cataract surgery in diabetic patients, indicating that SP and MCP-1 were involved in the sympathetic inflammatory responses. Diabetic patients are susceptible to noninfectious inflammation after cataract surgery, and perceive more pain in the second-eye phacoemulsification.
TRIAL REGISTRATION


Chinese Clinical Trial Registry, ChiCTR1900028374 , retrospectively registered on 20th December, 2019.",2020,"Substance P and MCP-1 productions elevated in the AH of the contralateral eye after the first-eye cataract surgery in diabetic patients, indicating that SP and MCP-1 were involved in the sympathetic inflammatory responses.","['patients with or without type 2 diabetes', 'Diabetic patients', 'Bilateral sequential cataract surgeries', '51 cataract patients (22 with diabetes and 29 without', 'type 2 diabetic patients']","['Substance P (SP', 'Sequential second-eye cataract surgery']","['sympathetic immune response', 'Substance P and MCP-1 productions', 'pain', 'MCP-1 increase', 'SP and MCP-1 levels', 'SP increase']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}]","[{'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C0301872', 'cui_str': 'Immune response'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",51.0,0.0272176,"Substance P and MCP-1 productions elevated in the AH of the contralateral eye after the first-eye cataract surgery in diabetic patients, indicating that SP and MCP-1 were involved in the sympathetic inflammatory responses.","[{'ForeName': 'Xianhui', 'Initials': 'X', 'LastName': 'Gong', 'Affiliation': 'The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.'}, {'ForeName': 'Yueping', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'The Affiliated Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Xiuxiu', 'Initials': 'X', 'LastName': 'Fang', 'Affiliation': 'The Affiliated Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'Junyong', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'The Affiliated Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Song', 'Affiliation': 'Lixiang Eye Hospital of Soochow University, Suzhou, Jiangsu, China. songe@suda.edu.cn.'}]",BMC ophthalmology,['10.1186/s12886-020-01598-4']
2441,32811464,Can Samba and Forró Brazilian rhythmic dance be more effective than walking in improving functional mobility and spatiotemporal gait parameters in patients with Parkinson's disease?,"BACKGROUND


Parkinson's disease (PD) causes motor and nonmotor disorders in patients. Unlike aerobic training, potential adaptations from the practice of dance are less understood in PD, particularly compared with better known exercise modes. This study aimed to verify and compare the effects of a Brazilian dance program, inspired by Samba and Forrró rhythms, and a walking program on functional mobility and spatiotemporal gait parameters in patients with PD.
METHODS


Eighteen participants with PD were divided into a dance group (DG) and a walking group (WG) and were assessed before and after an intervention period of 24 1-h sessions, performed twice per week for 12 weeks. The timed-up-and-go test (TUG) and walking kinematics at self-selected speed (SSS) and fast speed (FS) were determined. The generalized estimating equation method was used to compare the DG and WG pre- and post-intervention and to evaluate the group*time interaction (α <  0.05).
RESULTS


Both groups demonstrated a significant improvement in TUG test at SSS (p = 0.02; effect size [ES] = 0.42) and FS (p = 0.02; ES = 0.24). In general, spatiotemporal parameters remained unchanged, except at SSS, in which the DG increased the stride frequency (p = 0.011; ES = 0.72). At FS, the swing time demonstrated a significant group*time interaction (p <  0.001; ES = 1.10), in which the two groups exhibited different behaviors: DG decreased (p = 0.015) and WG increased (p = 0.012).
CONCLUSIONS


Functional mobility improved similarly in both groups. The results suggest that a 12-week program of Brazilian dance was sufficient to produce improvements in functional mobility and gait in individuals with PD.
TRIAL REGISTRATION


This study is registered with the International Clinical Trial Registry under number NCT03370315 . Registered December 28, 2017 - Retrospectively registered.",2020,Both groups demonstrated a significant improvement in TUG test at SSS (p = 0.02; effect size [ES] = 0.42) and FS (p = 0.02; ES = 0.24).,"['individuals with PD', 'Eighteen participants with PD', ""patients with Parkinson's disease"", ""Parkinson's disease (PD) causes motor and nonmotor disorders in patients"", 'patients with PD']","['Brazilian dance program, inspired by Samba and Forrró rhythms, and a walking program', 'dance group (DG) and a walking group (WG']","['functional mobility and spatiotemporal gait parameters', 'stride frequency', 'functional mobility and gait', 'timed-up-and-go test (TUG) and walking kinematics at self-selected speed (SSS) and fast speed (FS', 'behaviors: DG', 'TUG test at SSS']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",18.0,0.0235388,Both groups demonstrated a significant improvement in TUG test at SSS (p = 0.02; effect size [ES] = 0.42) and FS (p = 0.02; ES = 0.24).,"[{'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Dos Santos Delabary', 'Affiliation': 'Federal University of Rio Grande do Sul, Street Felizardo, 750, Jardim Botânico, Porto Alegre, Rio Grande do Sul, Brazil. marcela_delabary@yahoo.com.br.'}, {'ForeName': 'Elren Passos', 'Initials': 'EP', 'LastName': 'Monteiro', 'Affiliation': 'Federal University of Pará, Street Guamá, Belém, Pará, Brazil.'}, {'ForeName': 'Rebeca Gimenes', 'Initials': 'RG', 'LastName': 'Donida', 'Affiliation': 'Federal University of Rio Grande do Sul, Street Felizardo, 750, Jardim Botânico, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Wolffenbuttel', 'Affiliation': 'Federal University of Rio Grande do Sul, Street Felizardo, 750, Jardim Botânico, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Leonardo Alexandre', 'Initials': 'LA', 'LastName': 'Peyré-Tartaruga', 'Affiliation': 'Federal University of Rio Grande do Sul, Street Felizardo, 750, Jardim Botânico, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Aline Nogueira', 'Initials': 'AN', 'LastName': 'Haas', 'Affiliation': 'Federal University of Rio Grande do Sul, Street Felizardo, 750, Jardim Botânico, Porto Alegre, Rio Grande do Sul, Brazil.'}]",BMC neurology,['10.1186/s12883-020-01878-y']
2442,32811480,A realist evaluation approach to explaining the role of context in the impact of a complex eHealth intervention for improving prevention of cardiovascular disease.,"BACKGROUND


Reduction of cardiovascular disease (CVD) is a worldwide health priority and innovative uses of technology-based interventions may assist patients with improving prevention behaviours. Targeting these interventions to recipients most likely to benefit requires understanding how contexts of use influence responsiveness to the intervention, and how this interaction favours or discourages health behaviour. Using a realist evaluation approach, the aim of this study was to examine the contextual factors influencing behaviour change within a multi-feature eHealth intervention with personalised data integration from the primary care electronic health record (EHR).
METHODS


Realist evaluation of qualitative data from the Consumer Navigation of Electronic Cardiovascular Tools (CONNECT) randomised trial (N = 934). Thirty-six participants from the intervention group (N = 486) who had completed 12 months of study follow-up were interviewed. Coding of transcripts was structured around configurations of contexts, mechanisms, and outcomes of intervention use. Contextual narratives were derived from thematic analysis of the interviews.
RESULTS


Mechanisms favouring positive health behaviour occurred when participants responded to four interactive features of the intervention. Facilitating mechanisms included greater cognitive engagement whereby participants perceived value and benefit, and felt motivated, confident and incentivised. Participants moved from being unconcerned (or unaware) to more task-oriented engagement with personal CVD risk profile and prevention. Increased personalisation occurred when modifiable CVD risk factors became relatable to lifestyle behaviour; and experiences of feeling greater agency/self-efficacy emerged. Use and non-use of the intervention were influenced by four overarching narratives within the individual's micro-level and meso-level environments: illness experiences; receptiveness to risk and prevention information; history of the doctor-patient relationship; and relationship with technology.
CONCLUSIONS


Intervention-context interactions are central to understanding how change mechanisms activate within complex interventions to exert their impact on recipients. Intervention use and non-use were context-dependent, underscoring the need for further research to target eHealth innovations to those most likely to benefit.",2020,Participants moved from being unconcerned (or unaware) to more task-oriented engagement with personal CVD risk profile and prevention.,"['Participants moved from being unconcerned (or unaware) to more task-oriented engagement with personal CVD risk profile and prevention', 'Thirty-six participants from the intervention group (N\u2009=\u2009486) who had completed 12\u2009months of study follow-up were interviewed']",['complex eHealth intervention'],['positive health behaviour'],"[{'cui': 'C1269909', 'cui_str': 'MOVED FROM'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",36.0,0.0727726,Participants moved from being unconcerned (or unaware) to more task-oriented engagement with personal CVD risk profile and prevention.,"[{'ForeName': 'Genevieve', 'Initials': 'G', 'LastName': 'Coorey', 'Affiliation': 'Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia. gcoorey@georgeinstitute.org.au.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Peiris', 'Affiliation': 'The George Institute for Global Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Lis', 'Initials': 'L', 'LastName': 'Neubeck', 'Affiliation': 'School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Redfern', 'Affiliation': 'The George Institute for Global Health, Sydney, New South Wales, Australia.'}]",BMC health services research,['10.1186/s12913-020-05597-5']
2443,32807241,"Multi-centre, three arm, randomized controlled trial on the use of methylprednisolone and unfractionated heparin in critically ill ventilated patients with pneumonia from SARS-CoV-2 infection: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES


To assess the hypothesis that an adjunctive therapy with methylprednisolone and unfractionated heparin (UFH) or with methylprednisolone and low molecular weight heparin (LMWH) are more effective in reducing any-cause mortality in critically-ill ventilated patients with pneumonia from SARS-CoV-2 infection compared to LMWH alone.
TRIAL DESIGN


The study is designed as a multi-centre, interventional, parallel group, superiority, randomized, investigator sponsored, three arms study. Patients, who satisfy all inclusion criteria and no exclusion criteria, will be randomly assigned to one of the three treatment groups in a ratio 1:1:1.
PARTICIPANTS


Inpatients will be recruited from 8 Italian Academic and non-Academic Intensive Care Units INCLUSION CRITERIA (ALL REQUIRED): 1. Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material) 2. Positive pressure ventilation (either non-invasive or invasive) from > 24 hours 3. Invasive mechanical ventilation from < 96 hours 4. PaO 2 /FiO 2  ratio lower than 150 mmHg 5. D-dimer level > 6 times the upper limit of normal reference range 6. C-reactive Protein > 6-fold upper the limit of normal reference range EXCLUSION CRITERIA: 1. Age < 18 years 2. On-going treatment with anticoagulant drugs 3. Platelet count < 100.000/mm 3  4. History of heparin-induced thrombocytopenia 5. Allergy to sodium enoxaparin or other LMWH, UFH or methylprednisolone 6. Active bleeding or on-going clinical condition deemed at high risk of bleeding contraindicating anticoagulant treatment 7. Recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery 8. Chronic assumption or oral corticosteroids 9. Pregnancy or breastfeeding or positive pregnancy test. In childbearing age women, before inclusion, a pregnancy test will be performed if not available 10. Clinical decision to withhold life-sustaining treatment or ""too sick to benefit"" 11. Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition) 12. Lack or withdrawal of informed consent INTERVENTION AND COMPARATOR: • LMWH group: patients in this group will be administered enoxaparin at standard prophylactic dosage. • LMWH + steroid group: patients in this group will receive enoxaparin at standard prophylactic dosage and methylprednisolone. • UFH + steroid group: patients in this group will receive UFH at therapeutic dosages and methylprednisolone. UFH will be administered intravenously in UFH + steroid group at therapeutic doses. The infusion will be started at an infusion rate of 18 UI/kg/hour and then modified to obtain aPTT Ratio in between the range of 1.5-2.0. aPTT will be periodically checked at intervals no longer than 12 hours. The treatment with UFH will be administered up to ICU discharge. After ICU discharge anticoagulant therapy may be interrupted or switched to prophylaxis with LMWH in the destination ward up to clinical judgement of the attending physician. Enoxaparin will be administered in both LMWH group and LMWH + steroid group at standard prophylactic dose (i.e., 4000 UI once day, increased to 6000 UI once day for patients weighting more than 90 kg). The treatment will be administered subcutaneously once a day up to ICU discharge. After ICU discharge it may be continued or interrupted in the destination ward up to clinical judgement of the attending physician. Methylprednisolone will be administered in both LMWH + steroid group and UHF + steroid group intravenously with an initial bolus of 0,5 mg/kg followed by administration of 0,5 mg/kg 4 times daily for 7 days, 0,5 mg/kg 3 times daily from day 8 to day 10, 0,5 mg/kg 2 times daily at days 11 and 12 and 0,5 mg/kg once daily at days 13 and 14.
MAIN OUTCOMES


Primary Efficacy Endpoint: All-cause mortality at day 28 Secondary Efficacy Endpoints: - Ventilation free days (VFDs) at day 28, defined as the total number of days that patient is alive and free of ventilation (either invasive or non-invasive) between randomization and day 28 (censored at hospital discharge). - Need of rescue administration of high-dose steroids or immune-modulatory drugs; - Occurrence of switch from non-invasive to invasive mechanical ventilation during ICU stay; - Delay from start of non-invasive ventilation to switch to invasive ventilation; - All-cause mortality at ICU discharge and hospital discharge; - ICU free days (IFDs) at day 28, defined as the total number of days between ICU discharge and day 28. - Occurrence of new infections from randomization to day 28; including infections by Candida, Aspergillus, Adenovirus, Herpes Virus e Cytomegalovirus - Occurrence of new organ dysfunction and grade of dysfunction during ICU stay. - Objectively confirmed venous thromboembolism, stroke or myocardial infarction; Safety endpoints: - Occurrence of major bleeding, defined as transfusion of 2 or more units of packed red blood cells in a day, bleeding that occurs in at least one of the following critical sites [intracranial, intra-spinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, or retroperitoneal], bleeding that necessitates surgical intervention and bleeding that is fatal (defined as a bleeding event that was the primary cause of death or contributed directly to death); - Occurrence of clinically relevant non-major bleeding, defined ad acute clinically overt bleeding that does not meet the criteria for major and consists of any bleeding compromising hemodynamic; spontaneous hematoma larger than 25 cm 2 , intramuscular hematoma documented by ultrasonography, haematuria that was macroscopic and was spontaneous or lasted for more than 24 hours after invasive procedures; haemoptysis, hematemesis or spontaneous rectal bleeding requiring endoscopy or other medical intervention or any other bleeding requiring temporary cessation of a study drug.
RANDOMIZATION


A block randomisation will be used with variable block sizes (block size 4-6-8), stratified by 3 factors: Centre, BMI (<30/≥30) and Age (<75/≥75). Central randomisation will be performed using a secure, web-based, randomisation system with an allocation ratio of 1:1:1. The allocation sequence will be generated by the study statistician using computer generated random numbers.
BLINDING (MASKING)


Participants to the study will be blinded to group assignment.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)


The target sample size is based on the hypothesis that the combined use of UHF and steroid versus the LMWH group will significantly reduce the risk of death at day 28. The overall sample size in this study is expected to be 210 with a randomization 1:1:1 and seventy patients in each group. Assuming an alpha of 2.5% (two tailed) and mortality rate in LMWH group of 50%, as indicated from initial studies of ICU patients, the study will have an 80% power to detect at least a 25 % absolute reduction in the risk of death between: a) LMHW + steroid group and LMWH group or b) UHF + steroid group and LMWH group. The study has not been sized to assess the difference between LMHW + steroid group and UHF + steroid group, therefore the results obtained from this comparison will need to be interpreted with caution and will need further adequately sized studies confirm the effect. On the basis of a conservative estimation, that 8 participating sites admit an average of 3 eligible patients per month per centre (24 patients/month). Assuming that 80 % of eligible patients are enrolled, recruitment of 210 participants will be completed in approximately 10 months.
TRIAL STATUS


Protocol version 1.1 of April 26 th , 2020. Recruitment start (expected): September 1 st , 2020 Recruitment finish (expected): June 30 th , 2021 TRIAL REGISTRATION: EudraCT number 2020-001921-30 , registered on April 15 th , 2020 AIFA approval on May 4 th , 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Central randomisation will be performed using a secure, web-based, randomisation system with an allocation ratio of 1:1:1.","['Patients, who satisfy all inclusion criteria and no exclusion criteria', 'critically ill ventilated patients with pneumonia from SARS-CoV-2 infection', 'Inpatients will be recruited from 8 Italian Academic and non-Academic Intensive Care Units INCLUSION CRITERIA (ALL REQUIRED): 1', 'Protocol version 1.1 of April 26 th , 2020', 'Age', '0,5', 'group', '2020-001921-30 , registered on April 15 th , 2020 AIFA approval on May 4 th ', 'critically-ill ventilated patients with pneumonia from SARS-CoV-2 infection compared to LMWH alone']","['Invasive mechanical ventilation', 'LMWH, UFH or methylprednisolone 6', 'LMWH', 'Positive pressure ventilation (either non-invasive or invasive', 'methylprednisolone and low molecular weight heparin (LMWH', 'UFH + steroid', 'LMWH + steroid group and UHF + steroid', 'LMWH + steroid', 'UFH', 'Enoxaparin', 'sodium enoxaparin', 'methylprednisolone', 'Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material', 'methylprednisolone and unfractionated heparin (UFH', 'enoxaparin', 'Methylprednisolone', 'methylprednisolone and unfractionated heparin']","['risk of death', 'Active bleeding', 'Platelet count', 'cause mortality at day 28 Secondary Efficacy Endpoints: - Ventilation free days (VFDs) at day 28, defined as the total number of days', 'infections by Candida, Aspergillus, Adenovirus, Herpes Virus e Cytomegalovirus - Occurrence of new organ dysfunction and grade of dysfunction during ICU stay', 'venous thromboembolism, stroke or myocardial infarction; Safety endpoints: - Occurrence of major bleeding, defined as transfusion of 2 or more units of packed red blood cells', 'mortality rate', 'Pregnancy or breastfeeding or positive pregnancy test', 'life expectancy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}]","[{'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0006836', 'cui_str': 'Candida'}, {'cui': 'C0004034', 'cui_str': 'Aspergillus'}, {'cui': 'C0001483', 'cui_str': 'Adenoviridae'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0240802', 'cui_str': 'Pregnancy test positive'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}]",210.0,0.145771,"Central randomisation will be performed using a secure, web-based, randomisation system with an allocation ratio of 1:1:1.","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Busani', 'Affiliation': 'Anaesthesia and Intensive Care Unit, Terapia Intensiva Polivalente, Policlinico di Modena, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Via del Pozzo, 71, 41124, Modena, Italy. stefano.busani@unimore.it.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Tosi', 'Affiliation': 'Anaesthesia and Intensive Care Unit, Terapia Intensiva Polivalente, Policlinico di Modena, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Via del Pozzo, 71, 41124, Modena, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Mighali', 'Affiliation': 'Servizio Formazione, Ricerca e Innovazione, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Vandelli', 'Affiliation': 'Servizio Formazione, Ricerca e Innovazione, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': ""Cattedra di Statistica Medica, Dipartimento di Scienze Mediche e Chirurgiche Materno-Infantili e dell'Adulto, Università di Modena e Reggio Emilia, Modena, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Marietta', 'Affiliation': 'Haematology Unit, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Modena, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Forfori', 'Affiliation': 'Dipartimento di Anestesia e Terapia Intensiva, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy.'}, {'ForeName': 'Abele', 'Initials': 'A', 'LastName': 'Donati', 'Affiliation': 'Anaesthesia and Intensive Care Unit, Department of Biomedical Sciences and Public Health, Università Politecnica delle Marche, Torrette di Ancona, Italy.'}, {'ForeName': 'Gilda', 'Initials': 'G', 'LastName': 'Cinnella', 'Affiliation': 'Department of Anesthesia and Intensive Care, O.O. Riuniti Hospital, University of Foggia, Foggia, Italy.'}, {'ForeName': 'Amato', 'Initials': 'A', 'LastName': 'De Monte', 'Affiliation': 'Anesthesiology and Intensive Care 1, Department of Anesthesia and Intensive Care, Azienda Sanitaria Universitaria Integrata-Udine, Udine, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pasero', 'Affiliation': 'Department of Medical, Surgical and Experimental Science, University of Sassari, Sassari, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Bellani', 'Affiliation': 'Department of Emergency and Intensive Care, San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Tascini', 'Affiliation': 'Clinica di Malattie Infettive, Azienda Sanitaria Universitaria Friuli centrale, Udine, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Foti', 'Affiliation': 'Department of Emergency Medicine, San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ranieri', 'Affiliation': ""Anesthesia and Intensive Care Medicine, University Hospital of Bologna Sant'Orsola, Alma Mater Studiorum, University of Bologna, Bologna, Italy.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Girardis', 'Affiliation': 'Anaesthesia and Intensive Care Unit, Terapia Intensiva Polivalente, Policlinico di Modena, Azienda Ospedaliero-Universitaria di Modena, Ospedale Policlinico, Via del Pozzo, 71, 41124, Modena, Italy.'}]",Trials,['10.1186/s13063-020-04645-z']
2444,32807252,COMPARING THE EFFECTS OF WHEY AND CASEIN SUPPLEMENTATION ON NUTRITIONAL STATUS AND IMMUNE PARAMETERS IN PATIENTS WITH CHRONIC LIVER DISEASE - A RANDOMIZED DOUBLE-BLIND CONTROLLED TRIAL.,"Protein supplementation may be beneficial for patients with chronic liver disease (CLD). This study compared the effects of whey protein isolate (WP) and casein (CA) supplementation on nutritional status and immune parameters of CLD patients who were randomly assigned to take 20 g of WP or CA twice a day as a supplement for 15 days. Body composition, muscle functionality and plasmatic immunomarkers were assessed before and after supplementation. Patients were also classified according to the model for end-stage liver disease (MELD) into less (MELD <15) and more (MELD≥15) more severe disease groups. Malnutrition, determined by the Subjective Global Assessment at baseline, was observed in 57.4% and 54.2% of patients in the WP and CA groups, respectively (p=0.649). Protein intake was lower at baseline in the WP group than in the CA group (p=0.035), with no difference after supplementation (p=0.410). Both the WP and CA MELD<15 groups increased protein intake after supplementation according to intragroup analysis. No differences were observed in body composition, muscle functionality, most plasma cytokines (TNF, IL-6, IL-1β and IFN-γ), immunomodulatory proteins (sTNFR1, sTNFR2, BDNF and GDNF), or immunomodulatory hormones (adiponectin, insulin, and leptin) after supplementation in the WP groups at the two assessed moments. WP supplementation increased the levels of IP-10/CXCL10 (p=0.022), eotaxin-1/CCL11 (p=0.031) and MCP-1/CCL2 (p=0.018) and decreased IL-5 (p=0.027), including among those in the MELD≥15 group, for whom IL-10 was also increased (p=0.008). Thus, WP consumption by patients with CLD impacted the immunomodulatory responses when compared to CA with no impact on nutritional status.",2020,"WP supplementation increased the levels of IP-10/CXCL10 (p=0.022), eotaxin-1/CCL11","['CLD patients', 'patients with chronic liver disease (CLD', 'Patients were also classified according to the model for end-stage liver disease (MELD) into less (MELD <15) and more (MELD≥15) more severe disease groups']","['Protein supplementation', 'CA', 'WP and CA MELD<15', 'MCP-1/CCL2', 'WP supplementation', 'whey protein isolate (WP) and casein (CA) supplementation', 'WP or CA', 'eotaxin-1/CCL11']","['Protein intake', 'Subjective Global Assessment', 'protein intake', 'levels of IP-10/CXCL10', 'Body composition, muscle functionality and plasmatic immunomarkers', 'body composition, muscle functionality, most plasma cytokines (TNF, IL-6, IL-1β and IFN-γ), immunomodulatory proteins (sTNFR1, sTNFR2, BDNF and GDNF), or immunomodulatory hormones (adiponectin, insulin, and leptin', 'IL-5']","[{'cui': 'C0341439', 'cui_str': 'Chronic liver disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C3826979', 'cui_str': 'Model for end-stage liver disease'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0250604', 'cui_str': 'Eotaxin-1'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0451514', 'cui_str': 'Subjective global assessment'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0207072', 'cui_str': 'Glial Cell-Line Derived Neurotrophic Factor'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0021759', 'cui_str': 'Interleukin-5'}]",,0.0436261,"WP supplementation increased the levels of IP-10/CXCL10 (p=0.022), eotaxin-1/CCL11","[{'ForeName': 'Y G G', 'Initials': 'YGG', 'LastName': 'Mizubuti', 'Affiliation': 'University Hospital Liver Disease Program, Universidade Federal de Minas Gerais, Belo Horizonte30130-100, Minas Gerais, Brazil.'}, {'ForeName': 'E L M', 'Initials': 'ELM', 'LastName': 'Vieira', 'Affiliation': 'Neuroscience Program, Universidade Federal de Minas Gerais, Belo Horizonte30130-100, Minas Gerais, Brazil.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': 'Silva', 'Affiliation': 'University Hospital Liver Disease Program, Universidade Federal de Minas Gerais, Belo Horizonte30130-100, Minas Gerais, Brazil.'}, {'ForeName': 'M O', 'Initials': 'MO', 'LastName': ""d'Alessandro"", 'Affiliation': 'University Hospital Liver Disease Program, Universidade Federal de Minas Gerais, Belo Horizonte30130-100, Minas Gerais, Brazil.'}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': 'Generoso', 'Affiliation': 'University Hospital Liver Disease Program, Universidade Federal de Minas Gerais, Belo Horizonte30130-100, Minas Gerais, Brazil.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Teixeira', 'Affiliation': 'Neuroscience Program, Universidade Federal de Minas Gerais, Belo Horizonte30130-100, Minas Gerais, Brazil.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Lima', 'Affiliation': 'University Hospital Liver Disease Program, Universidade Federal de Minas Gerais, Belo Horizonte30130-100, Minas Gerais, Brazil.'}, {'ForeName': 'M I T D', 'Initials': 'MITD', 'LastName': 'Correia', 'Affiliation': 'University Hospital Liver Disease Program, Universidade Federal de Minas Gerais, Belo Horizonte30130-100, Minas Gerais, Brazil.'}]",The British journal of nutrition,['10.1017/S0007114520003219']
2445,32807267,"Modeling the Long-term Antibody Response and Duration of Immune Protection Induced by an Inactivated, Preservative-free Hepatitis A Vaccine (Healive) in Children.","Objective


Long-term seroprotection  via  the hepatitis A vaccine is essential for the prevention of disease from the hepatitis A virus (HAV). Due to documented difficulties during decade-long follow-ups after receiving vaccines, statistical-modeling approaches have been applied to predict the duration of immune protection.
Methods


Based on five-year follow-up data from a randomized positive-controlled trial among Chinese children (1-8 years old) following a 0, 6 months vaccination schedule, a power-law model accounting for the kinetics of B-cell turnover, as well as a modified power-law model considering a memory-B-cell subpopulation, were fitted to predict the long-term immune responses induced by HAV vaccination (Healive or Havrix). Anti-HAV levels of each individual and seroconversion rates up to 30 years after vaccination were predicted.
Results


A total of 375 participants who completed the two-dose vaccination were included in the analysis. Both models predicted that, over a life-long period, participants vaccinated with Healive would have close but slightly higher antibody titers than those of participants vaccinated with Havrix. Additionally, consistent with previous studies, more than 90% of participants were predicted to maintain seroconversion for at least 30 years. Moreover, the modified power-law model predicted that the antibody titers would reach a plateau level after nearly 15 years post-vaccination.
Conclusions


Based on the results of our modeling, Healive may adequately induce long-term immune responses following a 0, 6 months vaccination schedule in children  via  induction of memory B cells to provide stable and durable immune protection.",2020,"Both models predicted that, over a life-long period, participants vaccinated with Healive would have close but slightly higher antibody titers than those of participants vaccinated with Havrix.","['375 participants who completed the two-dose vaccination were included in the analysis', 'Children', 'Chinese children (1-8 years old']","['HAV vaccination (Healive or Havrix', 'Objective\n\n\nLong-term seroprotection  via']","['maintain seroconversion', 'Anti-HAV levels of each individual and seroconversion rates', 'antibody titers']","[{'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0019159', 'cui_str': 'Viral hepatitis, type A'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0700881', 'cui_str': 'Havrix'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0062524', 'cui_str': 'Antibody to hepatitis A virus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}]",375.0,0.0718855,"Both models predicted that, over a life-long period, participants vaccinated with Healive would have close but slightly higher antibody titers than those of participants vaccinated with Havrix.","[{'ForeName': 'Yong Pei', 'Initials': 'YP', 'LastName': 'Yu', 'Affiliation': ""College of Military Preventive Medicine, the Fourth Military Medical University, Xi'an 710032, Shaanxi, China;Peking University Clinical Research Institute, Peking University Health Science Center, Beijing 100191, China.""}, {'ForeName': 'Jiang Ting', 'Initials': 'JT', 'LastName': 'Chen', 'Affiliation': 'Sinovac Biotech, Beijing 100089, China.'}, {'ForeName': 'Zhi Wei', 'Initials': 'ZW', 'LastName': 'Jiang', 'Affiliation': 'Beijing Keytech Statistical Consulting, Beijing 100020, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""College of Military Preventive Medicine, the Fourth Military Medical University, Xi'an 710032, Shaanxi, China.""}, {'ForeName': 'Cheng Kai', 'Initials': 'CK', 'LastName': 'Yu', 'Affiliation': ""College of Military Preventive Medicine, the Fourth Military Medical University, Xi'an 710032, Shaanxi, China.""}, {'ForeName': 'Xiao Yan', 'Initials': 'XY', 'LastName': 'Yan', 'Affiliation': 'Peking University Clinical Research Institute, Peking University Health Science Center, Beijing 100191, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yao', 'Affiliation': 'Peking University Clinical Research Institute, Peking University Health Science Center, Beijing 100191, China.'}, {'ForeName': 'Jie Lai', 'Initials': 'JL', 'LastName': 'Xia', 'Affiliation': ""College of Military Preventive Medicine, the Fourth Military Medical University, Xi'an 710032, Shaanxi, China.""}]",Biomedical and environmental sciences : BES,['10.3967/bes2020.065']
2446,32807294,Effect of a behavioral-educational sleep intervention for first-time mothers and their infants: pilot of a controlled trial.,"STUDY OBJECTIVES


This study tested the acceptability and efficacy of a perinatally delivered behavioral-educational sleep intervention.
METHODS


Participants were 40 primiparous women assigned in late pregnancy to either an intervention (n = 20) or control (n = 20) group. The sleep intervention group (SIG) received prenatal anticipatory education and guidance regarding their own and their infant's sleep during the first 3 months postpartum. This was reinforced during phone calls within the first 6 weeks postpartum. The control group (CG) received brief sleep hygiene information at a prenatal session, followed by 2 phone calls during the same period. Mother-infant pairs wore actigraphs for 48 hours at 6 and 12 weeks postpartum, and mothers kept sleep diaries. Questionnaires completed in late pregnancy and 6 and 12 weeks postpartum related to sleep, newborn care, and mood. The main outcome measures included maternal sleep quantity, efficiency, and self-reported quality and infant sleep duration and consolidation.
RESULTS


Mothers reported high acceptability of the study processes. Sleep duration and quality increased for mothers and infants across time in both groups, with a significantly greater increase in nocturnal sleep duration for mothers in the SIG.
CONCLUSIONS


Prenatal sleep guidance and postnatal follow-up seems to enhance nocturnal sleep of mothers, change their perceptions of their own sleep, and increase confidence in managing their infant's sleep. Follow-up at later intervals and replication with larger, more diverse samples may reveal further differences.",2020,"Sleep duration and quality increased for mothers and infants across time in both groups, with a significantly greater increase in nocturnal sleep duration for mothers in the SIG.
","['Participants were 40 primiparous women assigned in late pregnancy to either an intervention (n = 20) or control (n = 20) group', 'first-time mothers and their infants']","['behavioral-educational sleep intervention', 'control group (CG) received brief sleep hygiene information', ""sleep intervention group (SIG) received prenatal anticipatory education and guidance regarding their own and their infant's sleep"", 'perinatally delivered behavioral-educational sleep intervention']","['Sleep duration and quality', 'maternal sleep quantity, efficiency, and self-reported quality and infant sleep duration and consolidation', 'nocturnal sleep duration', 'sleep, newborn care, and mood', 'acceptability and efficacy']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C4277672', 'cui_str': 'Good Sleep Habits'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}]","[{'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0204792', 'cui_str': 'Routine care of newborn'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",40.0,0.0489197,"Sleep duration and quality increased for mothers and infants across time in both groups, with a significantly greater increase in nocturnal sleep duration for mothers in the SIG.
","[{'ForeName': 'Bronwyn M', 'Initials': 'BM', 'LastName': 'Sweeney', 'Affiliation': 'Sleep/Wake Research Centre, College of Health, Massey University, Wellington, New Zealand.'}, {'ForeName': 'T Leigh', 'Initials': 'TL', 'LastName': 'Signal', 'Affiliation': 'Sleep/Wake Research Centre, College of Health, Massey University, Wellington, New Zealand.'}, {'ForeName': 'Duncan R', 'Initials': 'DR', 'LastName': 'Babbage', 'Affiliation': 'Centre for Person Centered Research, Auckland University of Technology, Auckland, New Zealand.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8484']
2447,32807659,In vivo efficacy of silver-impregnated barrel contact lens storage cases.,"PURPOSE


This study examined the rate and level of microbial contamination of silver and non-silver (control) barrel contact lens storage cases in vivo.
METHODS


A prospective, single-centre, randomized, double blinded, crossover study was conducted to evaluate the efficacy of silver and control barrel cases used with an Oxipol™-based disinfecting solution over a two-month period. Lens cases were collected, and the frequency, type and level of microbial contamination evaluated using viable culture and standard identification methods. Questionnaires were used to assess the contact lens-related hygiene compliance of the participants.
RESULTS


Forty eight daily contact lens wearers completed the study. Overall, 27 % of silver and 35 % control lens cases (P > 0.05) were contaminated, predominantly with Gram-positive bacteria. Only, 12 % of participants had good compliance, with 46 % having average compliance and 43 % poor compliance. Compliance score was not associated with level of microbial contamination. However, the use of hydrogel lenses in combination with silver cases compared to non-silver barrel cases resulted significantly greater numbers of bacteria colonising cases.
CONCLUSION


The present investigation demonstrated that the use of silver barrel cases does not reduce the overall rate and level of bacterial contamination, but that using hydrogel lenses in combination with silver cases resulted in higher numbers of bacteria isolated from cases.",2020,"Overall, 27 % of silver and 35 % control lens cases (P > 0.05) were contaminated, predominantly with Gram-positive bacteria.","['lens storage cases', 'Forty eight daily contact lens wearers completed the study']","['silver and non-silver (control) barrel contact lens storage cases', 'silver-impregnated barrel contact', 'silver and control barrel cases used with an Oxipol™-based disinfecting solution', 'hydrogel lenses']","['Compliance score', 'overall rate and level of bacterial contamination', 'good compliance']","[{'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0920138', 'cui_str': 'Contact lens wearer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C4319631', 'cui_str': 'Barrel'}, {'cui': 'C1639526', 'cui_str': 'Contact lens storage case'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",48.0,0.0253468,"Overall, 27 % of silver and 35 % control lens cases (P > 0.05) were contaminated, predominantly with Gram-positive bacteria.","[{'ForeName': 'Ananya', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, NSW, Australia.'}, {'ForeName': 'Mark D P', 'Initials': 'MDP', 'LastName': 'Willcox', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, NSW, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Stapleton', 'Affiliation': 'School of Optometry and Vision Science, UNSW Sydney, NSW, Australia. Electronic address: f.stapleton@unsw.edu.au.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.08.001']
2448,32807666,Hyperbaric oxygen therapy following percutaneous coronary intervention for ST-segment elevation myocardial infarction.,"INTRODUCTION


Hyperbaric oxygen therapy (HBOT) is a promising treatment modality for ischemic heart disease including myocardial infarction where outcomes are frequently poor despite early revascularization.
OBJECTIVE


To compare single-photon emission computed tomography (SPECT) findings in patients undergoing primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI) treated with HBOT vs. control at 6 weeks.
METHODS


In this pilot study, 24 patients were randomly allocated to HBOT (n = 13) and control groups (n = 11). Both groups underwent PPCI and were treated following the guidelines for STEMI management. The HBOT group received additional 15 and 90-minute HBOT sessions. All participants underwent SPECT at initial presentation (within 48 h of PPCI) and at follow up.
RESULTS


Baseline characteristics were similar in both groups. The number of affected SPECT segments in the HBOT group at baseline and 6 weeks were 47.1 ± 14.6% vs. 33.7 ± 16.2%, respectively, with p = 0.039, and in the control group, the number of affected segment at these times were 55.5 ± 19.5% vs. 45.9 ± 17.9%, respectively, with p = 0.090. At follow-up, a decrease in the summed rest score was noted in both groups (HBOT: 20 ± 6.0 vs. 12.7 ± 8.1; p = 0.0017; control: 23 ± 8.2 vs. 16.7 ± 6.6; p = 0.031). The left ventricular ejection fraction in the HBOT group improved from 44 ± 22.1% to 57.2 ± 15.4% (p = 0.011) and in the control group from 45.9 ± 18.2% to 55 ± 12.1% (p = 0.044).
CONCLUSIONS


HBOT use in STEMI patients was associated with an improvement in perfusion and an increase in ejection fraction following PPCI. These observations warrant a larger randomized clinical trial.",2020,"The left ventricular ejection fraction in the HBOT group improved from 44 ± 22.1% to 57.2 ± 15.4% (p = 0.011) and in the control group from 45.9 ± 18.2% to 55 ± 12.1% (p = 0.044).
","['percutaneous coronary intervention for ST-segment elevation myocardial infarction', '24 patients', 'patients undergoing primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI) treated with HBOT vs. control at 6\u202fweeks']","['single-photon emission computed tomography (SPECT', 'HBOT', 'Hyperbaric oxygen therapy', 'Hyperbaric oxygen therapy (HBOT']","['number of affected SPECT segments', 'left ventricular ejection fraction', 'ejection fraction', 'summed rest score']","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C0020431', 'cui_str': 'Hyperbaric oxygen therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",24.0,0.0410681,"The left ventricular ejection fraction in the HBOT group improved from 44 ± 22.1% to 57.2 ± 15.4% (p = 0.011) and in the control group from 45.9 ± 18.2% to 55 ± 12.1% (p = 0.044).
","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Martín-Hernández', 'Affiliation': 'Cardiología Intervencionista del Hospital Central Militar, Mexico. Electronic address: calidad.hmz.mexicali@sedena.gob.mx.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Gutiérrez-Leonard', 'Affiliation': 'Cardiología Intervencionista del Hospital Central Militar, Mexico.'}, {'ForeName': 'Asanté Reymon', 'Initials': 'AR', 'LastName': 'Quintana', 'Affiliation': 'Medstar Washington Hospital Center, United States of America.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Ojeda-Delgado', 'Affiliation': 'Cardiología Intervencionista del Hospital Central Militar, Mexico.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Montes-Bautista', 'Affiliation': 'Cardiología del Hospital Central Militar, Mexico.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Valdéz-Becerril', 'Affiliation': 'Medicina Nuclear del Hospital Central Militar, Mexico.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Aguirre-Alvarado', 'Affiliation': 'Medicina Hiperbárica del Hospital Central Militar, Mexico.'}, {'ForeName': 'Lázaro', 'Initials': 'L', 'LastName': 'Hernández-Jiménez', 'Affiliation': 'Cuidados Intensivos Cardiovasculares, Mexico.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2020.04.031']
2449,32807709,Feasibility and results of an intensive cardiac rehabilitation program. Insights from the MxM (Más por Menos) randomized trial.,"INTRODUCTION AND OBJECTIVES


Cardiac rehabilitation programs (CRP) are a set of interventions to improve the prognosis of cardiovascular disease by influencing patients' physical, mental, and social conditions. However, there are no studies evaluating the optimal duration of these programs. We aimed to compare the results of a standard vs a brief intensive CRP in patients after ST-segment elevation and non-ST-segment elevation acute coronary syndrome through the Más por Menos study (More Intensive Cardiac Rehabilitation Programs in Less Time).
METHODS


In this prospective, randomized, open, evaluator-blind for end-point, and multicenter trial (PROBE design), patients were randomly allocated to either standard 8-week CRP or intensive 2-week CRP with booster sessions. A final visit was performed 12 months later, after completion of the program. We assessed adherence to the Mediterranean diet, psychological status, smoking, drug therapy, functional capacity, quality of life, cardiometabolic and anthropometric parameters, cardiovascular events, and all-cause mortality during follow-up.
RESULTS


A total of 497 patients (mean age, 57.8±10.0 years; 87.3% men) were finally assessed (intensive: n=262; standard: n=235). Baseline characteristics were similar between the 2 groups. At 12 months, the results of treadmill ergometry improved by ≥ 1 MET in ≥ 93% of the patients. In addition, adherence to the Mediterranean diet and quality of life were significantly improved by CRP, with no significant differences between the groups. The occurrence of cardiovascular events was similar in the 2 groups.
CONCLUSIONS


Intensive CRP could be as effective as standard CRP in achieving adherence to recommended secondary prevention measures after acute coronary syndrome and could be an alternative for some patients and centers. Registered at ClinicalTrials.gov (Identifier: NCT02619422).",2020,"In addition, adherence to the Mediterranean diet and quality of life were significantly improved by CRP, with no significant differences between the groups.","['patients after ST-segment elevation and non-ST-segment elevation acute coronary syndrome through the Más por Menos study (More Intensive Cardiac Rehabilitation Programs in Less Time', '497 patients (mean age, 57.8±10.0 years; 87.3% men) were finally assessed (intensive: n=262; standard: n=235']",['intensive cardiac rehabilitation program'],"['treadmill ergometry', 'adherence to the Mediterranean diet and quality of life', 'adherence to the Mediterranean diet, psychological status, smoking, drug therapy, functional capacity, quality of life, cardiometabolic and anthropometric parameters, cardiovascular events, and all-cause mortality', 'occurrence of cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C3160886', 'cui_str': 'Non ST segment elevation acute coronary syndrome'}, {'cui': 'C0376250', 'cui_str': 'Portuguese language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0085143', 'cui_str': 'Ergometry'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",497.0,0.0368514,"In addition, adherence to the Mediterranean diet and quality of life were significantly improved by CRP, with no significant differences between the groups.","[{'ForeName': 'Almudena', 'Initials': 'A', 'LastName': 'Castro-Conde', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario La Paz, Madrid, Spain. Electronic address: almudenacastroc@gmail.com.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Abeytua', 'Affiliation': 'Servicio de Cardiología, Hospital Gregorio Marañón, Madrid, Spain.'}, {'ForeName': 'Vicente I', 'Initials': 'VI', 'LastName': 'Arrarte Esteban', 'Affiliation': 'Servicio de Cardiología, Hospital General Universitario de Alicante, ISABIAL-FISABIO, Alicante, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Caravaca Pérez', 'Affiliation': 'Servicio de Cardiología, Hospital Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Dalmau González-Gallarza', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Garza Benito', 'Affiliation': 'Servicio de Cardiología, Unidad de Rehabilitación Cardiaca, Hospital Nuestra Señora de Gracia, Zaragoza, Spain.'}, {'ForeName': 'Rafael J', 'Initials': 'RJ', 'LastName': 'Hidalgo Urbano', 'Affiliation': 'Servicio de Cardiología, Hospital Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Torres Marqués', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Son Llàtzer, Instituto de Investigación Sanitaria Islas Baleares (IdISBa), Palma de Mallorca, Balearic Islands, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Vidal-Pérez', 'Affiliation': 'Servicio de Cardiología, Hospital Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'Iván J', 'Initials': 'IJ', 'LastName': 'Nuñez-Gil', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico San Carlos, Madrid, Spain.'}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2020.03.029']
2450,32807726,"Letter to editor ""Effectiveness of additional deep-water running for disability, lumbar pain intensity, and functional capacity in patients with chronic low back pain: A randomised controlled trial with 3-month follow-up"".",,2020,,['patients with chronic low back pain'],"['Letter to editor ', 'additional deep-water running']","['disability, lumbar pain intensity, and functional capacity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0450462', 'cui_str': 'Running water'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}]",,0.137973,,"[{'ForeName': 'Gurjant', 'Initials': 'G', 'LastName': 'Singh', 'Affiliation': 'Department of Musculoskeletal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, 133207, Haryana, India. Electronic address: singh.gurjant@mmumullana.org.'}, {'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Kothiyal', 'Affiliation': 'Department of Musculoskeletal Physiotherapy, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, 133207, Haryana, India. Electronic address: saumya.kothiyal@mmumullana.org.'}]",Musculoskeletal science & practice,['10.1016/j.msksp.2020.102227']
2451,32808164,Comparing the trabecular outflow by the response to topical pilocarpine in patients with and without glaucoma filtering surgery.,"PURPOSE


To compare the trabecular outflow by the response to topical pilocarpine administration in patients with and without prior glaucoma filtering surgery.
STUDY DESIGN


Prospective, cross-sectional, randomized, double-blinded study.
METHODS


Open-angle glaucoma (OAG) patients without any prior glaucoma surgery, and those with prior trabeculectomy or tube shunt surgery aged 18-90 years were included. Both groups were randomized into pilocarpine or artificial tears (ATs). Intraocular pressure (IOP) was measured before and 90 min after the instillation of eye drops.
RESULTS


A total of 189 eyes of 189 patients were included: 92 eyes in the pilocarpine and 97 eyes in the ATs group. There was a mean ± standard deviation of - 0.81 ± 3.08 mmHg decrease in IOP with pilocarpine in those without prior surgery, significantly higher than the ATs group (0.55 ± 2.31 mmHg; p = 0.02). No significant change in IOP with pilocarpine was noted in the surgical group compared to the ATs group (p = 0.90). In the surgery group, greater IOP reduction was observed with pilocarpine in those who had undergone surgery within the last three years than those who had surgery three or more years prior (- 1.56 ± 2.64 versus 1.41 ± 2.77 mmHg; p = 0.001).
CONCLUSION


Less IOP reduction was observed with pilocarpine in patients who had filtering surgery more than three years previously compared to those with more recent surgery.",2020,No significant change in IOP with pilocarpine was noted in the surgical group compared to the ATs group (p = 0.90).,"['patients with and without prior glaucoma filtering surgery', 'patients with and without glaucoma filtering surgery', 'A total of 189 eyes of 189 patients were included: 92 eyes in the pilocarpine and 97 eyes in the ATs group', 'Open-angle glaucoma (OAG) patients without any prior glaucoma surgery, and those with prior trabeculectomy or tube shunt surgery aged 18-90\xa0years were included']","['pilocarpine', 'topical pilocarpine', 'pilocarpine or artificial tears (ATs']","['IOP with pilocarpine', 'IOP reduction', 'IOP', 'Intraocular pressure (IOP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031923', 'cui_str': 'Pilocarpine'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0197489', 'cui_str': 'Operation for glaucoma'}, {'cui': 'C0040574', 'cui_str': 'Trabeculoplasty'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0542331', 'cui_str': 'Shunt'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031923', 'cui_str': 'Pilocarpine'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0031923', 'cui_str': 'Pilocarpine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",189.0,0.140909,No significant change in IOP with pilocarpine was noted in the surgical group compared to the ATs group (p = 0.90).,"[{'ForeName': 'Melih', 'Initials': 'M', 'LastName': 'Ustaoglu', 'Affiliation': 'Glaucoma Research Center, Wills Eye Hospital, Philadelphia, PA, USA. drmelihustaoglu@gmail.com.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Masoumpour', 'Affiliation': 'Poostchi Ophthalmology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Sanvicente', 'Affiliation': 'Glaucoma Research Center, Wills Eye Hospital, Philadelphia, PA, USA.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Gulati', 'Affiliation': 'Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Razeghinejad', 'Affiliation': 'Glaucoma Research Center, Wills Eye Hospital, Philadelphia, PA, USA.'}]",Japanese journal of ophthalmology,['10.1007/s10384-020-00764-x']
2452,32808179,Hydraulic conductance of dentin after treatment with fluoride toothpaste containing sodium trimetaphosphate microparticles or nanoparticles.,"OBJECTIVES


To evaluate the hydraulic conductance of dentin after treatment with fluoride toothpastes containing sodium trimetaphosphate microparticles (TMPmicro) or nanoparticles (TMPnano).
MATERIALS AND METHODS


The dentinal tubules of bovine dentin blocks (4 × 4 × 1 mm) were unobstructed for determination of the maximum hydraulic conductance of the dentin. The dentin blocks were randomized into four groups (n = 15/group) of toothpastes (placebo, 1100 ppm F, and 1100 with 3% TMPmicro or 3% TMPnano) which were applied for 7 days (2×/day) using a brushing machine. The dentin surface (5/group) was analyzed by scanning electron microscopy. The hydraulic conductance post-treatment was measured in the other ten blocks. Thereafter, the same blocks were immersed in citric acid (pH 3.2) for 1 min, and the conductance was determined again. The data were submitted to 2-way ANOVA repeated measures, followed by the Student-Newman-Keuls test (p < 0.05).
RESULTS


The percentage conductance reduction post-treatment for the groups were placebo = 1100 ppm F < 1100 TMPnano < 1100 TMPmicro (p < 0.001). After acid attack, the percentage reduction was placebo < 1100 ppm F < 1100 TMPnano < 1100 TMPmicro (p < 0.001). The toothpastes containing TMP showed the highest obliteration of dentinal tubules.
CONCLUSIONS


The addition of TMPmicro to fluoride toothpaste produced a greater reduction in hydraulic conductance when compared with 1100 ppm F toothpaste.
CLINICAL RELEVANCE


The increased capacity of toothpastes containing TMP to reduce hydraulic conductance indicates their potential to reduce symptoms of dentinal hypersensitivity.",2020,"The addition of TMPmicro to fluoride toothpaste produced a greater reduction in hydraulic conductance when compared with 1100 ppm F toothpaste.
",[' 1100'],"['fluoride toothpaste containing sodium trimetaphosphate microparticles or nanoparticles', 'toothpastes (placebo, 1100 ppm F, and 1100 with 3% TMPmicro or 3% TMPnano', 'toothpastes containing TMP', 'fluoride toothpastes containing sodium trimetaphosphate microparticles (TMPmicro) or nanoparticles (TMPnano', 'TMPnano', 'placebo']","['Hydraulic conductance of dentin', 'hydraulic conductance post-treatment', 'dentinal tubules of bovine dentin blocks', 'hydraulic conductance', 'highest obliteration of dentinal tubules']","[{'cui': 'C4517537', 'cui_str': '1100'}]","[{'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C2350307', 'cui_str': 'Microparticles, Cell-Derived'}, {'cui': 'C1450054', 'cui_str': 'Nanoparticles'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517537', 'cui_str': '1100'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0040079', 'cui_str': 'Deoxythymidylic acid'}]","[{'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0227017', 'cui_str': 'Dentinal tubules'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332465', 'cui_str': 'Obliteration'}]",,0.0381795,"The addition of TMPmicro to fluoride toothpaste produced a greater reduction in hydraulic conductance when compared with 1100 ppm F toothpaste.
","[{'ForeName': 'Carla Oliveira', 'Initials': 'CO', 'LastName': 'Favretto', 'Affiliation': 'School of Dentistry, Araçatuba, Department of Preventive and Restorative, São Paulo State University (UNESP), Araçatuba, SP, Brazil.'}, {'ForeName': 'Alberto Carlos Botazzo', 'Initials': 'ACB', 'LastName': 'Delbem', 'Affiliation': 'School of Dentistry, Araçatuba, Department of Preventive and Restorative, São Paulo State University (UNESP), Araçatuba, SP, Brazil.'}, {'ForeName': 'Priscila Toninatto Alves', 'Initials': 'PTA', 'LastName': 'Toledo', 'Affiliation': 'School of Dentistry, Araçatuba, Department of Preventive and Restorative, São Paulo State University (UNESP), Araçatuba, SP, Brazil.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Pedrini', 'Affiliation': 'School of Dentistry, Araçatuba, Department of Diagnosis and Surgery, São Paulo State University (UNESP), Araçatuba, SP, Brazil. denise.pedrini@unesp.br.'}]",Clinical oral investigations,['10.1007/s00784-020-03516-w']
2453,32808209,Lifestyle Habits Associated with Weight Regain After Intentional Loss in Primary Care Patients Participating in a Randomized Trial.,"BACKGROUND


Though long-term weight loss maintenance is the treatment goal for obesity, weight regain is typical and few studies have evaluated lifestyle habits associated with weight regain.
OBJECTIVE


To identify dietary and physical activity habits associated with 6- and 24-month weight regain among participants in a weight loss maintenance clinical trial.
DESIGN


Secondary analysis of randomized clinical trial data.
PARTICIPANTS


Adult primary care patients with recent, intentional weight loss of at least 5%.
MAIN MEASURES


Lifestyle habits included consumption of low-fat foods, fish, desserts, sugary beverages, fruits, and vegetables and eating at restaurants from the Connor Diet Habit Survey; moderate-vigorous physical activity by self-report; steps recorded by a pedometer; and sedentary behavior by self-report. The outcome variable was weight change at 6 and 24 months. Linear regression models estimated adjusted associations between changes in weight and changes in dietary and physical activity habits.
KEY RESULTS


Overall, participants (mean (SD): 53.4 (12.2) years old; 26% male; 88% white) maintained weight loss at 6 months (n = 178, mean (SD): - 0.02 (5.70)% change) but began to regain weight by 24 months (n = 157, mean (SD): 4.22 (9.15)% increase). When considered all together, more eating at restaurants, reduced fish consumption, and less physical activity were most consistently associated with weight regain in fully adjusted models at both 6 and 24 months of follow-up. In addition, more sedentary behavior was associated with weight regain at 6 months while reduced consumption of low-fat foods, and more desserts and sugary beverages were associated with weight regain at 24 months.
CONCLUSIONS


Consuming less fish, fewer steps per day, and more frequent restaurant eating were most consistently associated with weight regain in primary care patients. Primary care providers may consider addressing specific lifestyle behaviors when counseling patients after successful weight loss.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT01946191.",2020,"When considered all together, more eating at restaurants, reduced fish consumption, and less physical activity were most consistently associated with weight regain in fully adjusted models at both 6 and 24 months of follow-up.","['participants in a weight loss maintenance clinical trial', 'Adult primary care patients with recent, intentional weight loss of at least 5']",[],"['weight regain', 'weight change', 'weight and changes in dietary and physical activity habits', 'physical activity', 'consumption of low-fat foods, fish, desserts, sugary beverages, fruits, and vegetables and eating at restaurants from the Connor Diet Habit Survey; moderate-vigorous physical activity by self-report; steps recorded by a pedometer; and sedentary behavior by self-report', 'Weight Regain', 'weight loss']","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C1563041', 'cui_str': 'Intentional weight loss'}]",[],"[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0453839', 'cui_str': 'Low fat food'}, {'cui': 'C0016163', 'cui_str': 'Fish'}, {'cui': 'C0453505', 'cui_str': 'Dessert'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0035255', 'cui_str': 'Restaurant'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0359383,"When considered all together, more eating at restaurants, reduced fish consumption, and less physical activity were most consistently associated with weight regain in fully adjusted models at both 6 and 24 months of follow-up.","[{'ForeName': 'Bethany Barone', 'Initials': 'BB', 'LastName': 'Gibbs', 'Affiliation': 'University of Pittsburgh, 32 Oak Hill Court, Pittsburgh, PA, USA. bbarone@pitt.edu.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Tudorascu', 'Affiliation': 'University of Pittsburgh, 32 Oak Hill Court, Pittsburgh, PA, USA.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Bryce', 'Affiliation': 'University of Pittsburgh, 32 Oak Hill Court, Pittsburgh, PA, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Comer', 'Affiliation': 'University of Pittsburgh, 32 Oak Hill Court, Pittsburgh, PA, USA.'}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Fischer', 'Affiliation': 'University of Pittsburgh, 32 Oak Hill Court, Pittsburgh, PA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hess', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Huber', 'Affiliation': 'University of Pittsburgh, 32 Oak Hill Court, Pittsburgh, PA, USA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'McTigue', 'Affiliation': 'University of Pittsburgh, 32 Oak Hill Court, Pittsburgh, PA, USA.'}, {'ForeName': 'Laurey R', 'Initials': 'LR', 'LastName': 'Simkin-Silverman', 'Affiliation': 'University of Pittsburgh, 32 Oak Hill Court, Pittsburgh, PA, USA.'}, {'ForeName': 'Molly B', 'Initials': 'MB', 'LastName': 'Conroy', 'Affiliation': 'University of Utah, Salt Lake City, UT, USA.'}]",Journal of general internal medicine,['10.1007/s11606-020-06056-x']
2454,32808234,"A mind-body lifestyle intervention enhances emotional control in patients with major depressive disorder: a randomized, controlled study.","To investigate the effects of the Dejian mind-body intervention (DMBI), on depressive symptoms and electroencephalography (EEG) changes in relation to emotional processing in patients with depression. Seventy-five age-, gender-, and education-matched participants with depression were randomly assigned to receive either Cognitive Behavior Therapy (CBT) or DMBI or were placed in a control group. Overall depressive syndrome, specific mood-related symptoms (Hamilton Psychiatric Rating Scale for Depression, Beck Depression Inventory), and EEG data were collected individually during a resting state and during affective image viewing before and after 10 weeks of intervention. After intervention, both the DMBI and CBT groups showed significantly reduced levels of overall depressive syndrome and mood-related symptoms (Ps ≤ 0.002) than the control group. In addition, the DMBI group demonstrated a significantly greater extent of elevation in fronto-posterior EEG theta coherence on the right hemisphere when viewing different mood-induction (neutral, positive, and negative) stimuli than the CBT and control groups (Ps < 0.03). The elevated intra-right fronto-posterior coherence when viewing mood-induction stimuli correlated with improved mood levels after the intervention (Ps < 0.05). Our findings also showed that, only in the DMBI group, there was a significant suppression of theta source activity at the posterior and subcortical brain regions that are known to mediate negative emotional responses and the self-absorbed mode of thinking. The findings of reduced depressive symptoms and elevated frontoposterior coherence suggest that the DMBI can enhance emotional control in depression.",2020,"After intervention, both the DMBI and CBT groups showed significantly reduced levels of overall depressive syndrome and mood-related symptoms (Ps ≤ 0.002) than the control group.","['patients with depression', 'education-matched participants with depression', 'Seventy-five age-, gender-, and', 'patients with major depressive disorder']","['A mind-body lifestyle intervention enhances emotional control', 'Cognitive Behavior Therapy (CBT) or DMBI', 'Dejian mind-body intervention (DMBI', 'DMBI']","['Overall depressive syndrome, specific mood-related symptoms (Hamilton Psychiatric Rating Scale for Depression, Beck Depression Inventory), and EEG data', 'mood levels', 'elevated intra-right fronto-posterior coherence', 'overall depressive syndrome and mood-related symptoms', 'elevation in fronto-posterior EEG theta coherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C1513305', 'cui_str': 'Mind-Body Medicine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0086133', 'cui_str': 'Depressive Syndrome'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0424113', 'cui_str': 'Level of mood'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",,0.0365269,"After intervention, both the DMBI and CBT groups showed significantly reduced levels of overall depressive syndrome and mood-related symptoms (Ps ≤ 0.002) than the control group.","[{'ForeName': 'Yvonne M Y', 'Initials': 'YMY', 'LastName': 'Han', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong SAR.'}, {'ForeName': 'Sophia L', 'Initials': 'SL', 'LastName': 'Sze', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong SAR.'}, {'ForeName': 'Queenie Y', 'Initials': 'QY', 'LastName': 'Wong', 'Affiliation': 'Division II, Kwai Chung Hospital, Kwai Chung, Hong Kong, SAR, China.'}, {'ForeName': 'Agnes S', 'Initials': 'AS', 'LastName': 'Chan', 'Affiliation': 'Department of Psychology, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong SAR. aschan@psy.cuhk.edu.hk.'}]","Cognitive, affective & behavioral neuroscience",['10.3758/s13415-020-00819-z']
2455,32808315,Variance formulae for multiphase stepped wedge cluster randomized trial.,"In a multiphase stepped wedge cluster randomized trial (MSW-CRT), more than one intervention will be initiated on each sequence in a fixed order. Hence, with the MSW-CRT design, the effect of the first intervention can be evaluated when compared to control, as well as the added-on effects of the subsequent interventions. Studies that use MSW-CRT have been proposed, but properties of this design have not been explicitly studied. We derive closed-form variance formulae to test the interventions' effects, which can be readily used for sample size and power calculation. Additionally, we provide relationships between variances to test the interventions' effects and design parameters. Under special conditions, some important properties include: (i) the variances to test different interventions' effects (ie, the first intervention effect and the second intervention effect) may be same; (ii) as the cluster-period mean autocorrelation increases, the variance to test an intervention effect may first increase and then decrease; (iii) as the amount of periods between the initiations of two interventions (ie, lag) increases, the variance to test an intervention effect may remain unchanged. We illustrate the relationships between power and design parameters using the variance formulae. From a few illustrative examples, we observe that the statistical test that uses data only relevant to a specific intervention has inferior power (relative power loss <15%) compared to the test when using all the study data. Also, power is reduced when both the total number of periods and lag are decreased simultaneously (relative power loss <20%).",2020,"From a few illustrative examples, we observe that the statistical test that uses data only relevant to a specific intervention has inferior power (relative power loss <15%) compared to the test when using all the study data.",[],['MSW-CRT'],[],[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],,0.0335308,"From a few illustrative examples, we observe that the statistical test that uses data only relevant to a specific intervention has inferior power (relative power loss <15%) compared to the test when using all the study data.","[{'ForeName': 'Pengyue', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Biomedical Informatics, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Shoben', 'Affiliation': 'Division of Biostatistics, College of Public Health, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Jackson', 'Affiliation': 'Departments of Physical Medicine and Rehabilitation, Internal Medicine/Endocrinology, and Diabetes and Metabolism, Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Fernandez', 'Affiliation': 'Department of Biomedical Informatics, Ohio State University, Columbus, Ohio, USA.'}]",Statistics in medicine,['10.1002/sim.8716']
2456,32808406,An international multicenter efficacy and safety study of IQYMUNE® in initial and maintenance treatment of patients with chronic inflammatory demyelinating polyradiculoneuropathy: PRISM study.,"BACKGROUND AND AIMS


This prospective, multicenter, single-arm, open-label phase 3 study aimed to evaluate the efficacy and safety of IqYmune® in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
METHODS


Patients received one induction dose of 2 g/kg and then 7 maintenance doses of 1 g/kg at 3-week intervals. The primary endpoint was the responder rate at the end of study (EOS), defined as an improvement of ≥1 point on the adjusted inflammatory neuropathy cause and treatment (INCAT) disability scale. The responder rate was compared with the responder rate of a historical placebo group (33.3%). Secondary endpoints included changes from baseline to EOS of adjusted INCAT disability score, grip strength, Medical Research Council (MRC) sum score, Rasch-modified MRC sum score, Rasch-built overall disability scale score and the clinical global impression.
RESULTS


Forty-two patients, including 23 Ig-naïve and 19 Ig-pre-treated, were included in the efficacy set. The overall response rate at EOS was 76.2% (95% confidence interval [60.5-87.9%]). The superiority of IqYmune® compared to the historical placebo control was demonstrated (p<0.0001). The responder rate was numerically higher in Ig-pre-treated than in Ig-naïve patients but confidence intervals were overlapping (84.2% [60.4-96.6%] vs. 69.6% [47.1-86.8%]). All secondary endpoints confirmed this conclusion. The median time to response was 15 weeks [8.9-19.1 weeks]. A total of 156 adverse events including 5 serious were considered related to IqYmune®, 87.2% were mild. Neither hemolysis nor signs of renal or hepatic impairment were observed.
INTERPRETATION


These results demonstrate that IqYmune® is an effective and well-tolerated treatment in patients with CIDP.",2020,The superiority of IqYmune® compared to the historical placebo control was demonstrated (p<0.0001).,"['patients with CIDP', 'patients with chronic inflammatory demyelinating polyradiculoneuropathy', 'patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP']","['historical placebo', '®', 'IqYmune®']","['overall response rate at EOS', 'responder rate', 'changes from baseline to EOS of adjusted INCAT disability score, grip strength, Medical Research Council (MRC) sum score, Rasch-modified MRC sum score, Rasch-built overall disability scale score and the clinical global impression', 'efficacy and safety', 'hemolysis nor signs of renal or hepatic impairment', 'median time to response', 'responder rate at the end of study (EOS), defined as an improvement of ≥1 point on the adjusted inflammatory neuropathy cause and treatment (INCAT) disability scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0032587', 'cui_str': 'Polyradiculoneuropathy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0270933', 'cui_str': 'Inflammatory neuropathy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019054', 'cui_str': 'Haemolysis'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}]",,0.16641,The superiority of IqYmune® compared to the historical placebo control was demonstrated (p<0.0001).,"[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Nobile-Orazio', 'Affiliation': 'Neuromuscular and Neuroimmunology Service, IRCCS Humanitas Clinical and Research center, Milan University, Milan, Italy.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Pujol', 'Affiliation': 'LFB, Les Ulis, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Kasiborski', 'Affiliation': 'LFB, Les Ulis, France.'}, {'ForeName': 'Rabye', 'Initials': 'R', 'LastName': 'Ouaja', 'Affiliation': 'LFB, Les Ulis, France.'}, {'ForeName': 'Gilles Della', 'Initials': 'GD', 'LastName': 'Corte', 'Affiliation': 'Dellmed Consulting, Ornex, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bonek', 'Affiliation': 'Department of Neurology, NeuroCenter, Bydgoszcz, Poland.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Cocito', 'Affiliation': 'Istituti Clinici Scientifici Maugeri, Turin, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Schenone', 'Affiliation': 'Department of Neurosciences, Rehabilitation, Ophthalmology, Genetic and Maternal and Infantile Sciences (DINOGMI), University of Genova and IRCCS Policlinico San Martino, Genova, Italy.'}]",Journal of the peripheral nervous system : JPNS,['10.1111/jns.12408']
2457,32808409,Influence of instrument assisted soft tissue techniques versus active soft tissue therapies on latent trigger point of upper trapezius muscle: Randomized clinical study.,"OBJECTIVES


To compare the effects of active soft tissue therapies versus Graston technique in chronic neck pain patients with latent trigger point of upper trapezius muscle.
METHODS


Design of the study was randomized clinical study. Forty-five female chronic neck pain patients with latent myofascial trigger points in the upper trapezius muscle were randomly assigned into equal groups of 15 subjects. Group (A) received stretching exercise and active soft tissue therapy, group (B) received stretching exercise and Graston technique and group (C) received stretching exercise only. Pain pressure threshold and cervical ranges of motions were obtained before and after treatment in each group.
RESULTS


Mixed MANOVA revealed that there was a significant interaction of treatment and time (F [14, 72] = 8.97, p = .001). There was a significant main effect of time (F [7, 36] = 699.15 p = .001). There was a significant main effect of treatment (F [14, 72] = 5.34, p = .001). Within-group comparison revealed a significant increase in PPT and cervical ROM in the three groups post treatment compared with that pretreatment (p < .001). Between groups comparisons pretreatment revealed a no significant difference in all parameters (p > .05). Comparison between groups post treatment revealed a significant increase in PPT and cervical flexion, extension, lateral flexion and rotation toward affected and non-affected side of group A and B compared with that of group C (p < .01). While there was no significant difference in in PPT and all cervical ROM between group A and B post treatment (p > .05).
CONCLUSION


The current study does not support the efficacy of IASTM in increasing pain pressure threshold and range of motion in chronic neck pain patients with latent trigger point of upper trapezius muscle when compared with other treatments.",2020,"Comparison between groups post treatment revealed a significant increase in PPT and cervical flexion, extension, lateral flexion and rotation toward affected and non-affected side of group A and B compared with that of group C (p < .01).","['chronic neck pain patients with latent trigger point of upper trapezius muscle', 'Forty-five female chronic neck pain patients with latent myofascial trigger points in the upper trapezius muscle', 'chronic neck pain patients']","['stretching exercise and active soft tissue therapy', 'instrument assisted soft tissue techniques versus active soft tissue therapies', 'stretching exercise and Graston technique and group (C) received stretching exercise only', 'active soft tissue therapies versus Graston technique', 'IASTM']","['PPT and all cervical ROM', 'PPT and cervical flexion, extension, lateral flexion and rotation toward affected and non-affected side', 'PPT and cervical ROM', 'pain pressure threshold and range of motion', 'Pain pressure threshold and cervical ranges of motions']","[{'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205275', 'cui_str': 'Latent'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3658309', 'cui_str': 'Soft Tissue Therapy'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}]",45.0,0.046273,"Comparison between groups post treatment revealed a significant increase in PPT and cervical flexion, extension, lateral flexion and rotation toward affected and non-affected side of group A and B compared with that of group C (p < .01).","[{'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Elserty', 'Affiliation': 'Basic Science Department, Faculty of Physical Therapy, Egyptian Chinese University, Cairo, Egypt.'}, {'ForeName': 'Dina Othman', 'Initials': 'DO', 'LastName': 'Shokri Morsi Galal', 'Affiliation': 'Department of Physical Therapy for Orthopedic Disorders and its Surgery, Faculty of Physical Therapy, Badr University, Cairo, Egypt.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1859']
2458,32808423,Motivational support programme to enhance health and well-being and promote weight loss in overweight and obese adolescents: A randomized controlled trial in Turkey.,"AIM


The aim of this study is to investigate the effect on health, well-being and weight loss of a motivational support programme provided for adolescents who were overweight and obese.
METHODS


This was a randomized controlled trial. Sixty-four adolescents (39 girls and 25 boys) who were overweight and obese and consulted at our polyclinic from January 2015 to February 2016 comprised the study population. The sociodemographic characteristics, well-being levels and physical parameters of the adolescents were evaluated. Routine follow-ups were practiced for both groups. The adolescents in the experimental group had motivational interviews and were sent reminder messages over a 6-month period, and education programmes were conducted with the parents.
RESULTS


After 6 months, the body mass index values had decreased in the experimental group compared with baseline, with no decrease in the controls. Scores for the Paediatric Quality of Life total scale and physical health and psychosocial health subscale points were increased in experimental and control groups, but the quality of life scale points of the experimental group were higher than the control group. In the experimental group, aspartate aminotransferase, alanine aminotransferase, insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and total cholesterol were decreased.
CONCLUSION


The motivational support programme affected the adolescents' health positively and can be recommended as a routine nursing intervention.",2020,"Scores for the Paediatric Quality of Life total scale and physical health and psychosocial health subscale points were increased in experimental and control groups, but the quality of life scale points of the experimental group were higher than the control group.","['adolescents who were overweight and obese', 'Sixty-four adolescents (39 girls and 25 boys) who were overweight and obese and consulted at our polyclinic from January 2015 to February 2016 comprised the study population', 'overweight and obese adolescents']","['motivational support programme', 'Motivational support programme']","['quality of life scale points', 'body mass index values', 'Paediatric Quality of Life total scale and physical health and psychosocial health subscale points', 'weight loss', 'aspartate aminotransferase, alanine aminotransferase, insulin, homeostasis model assessment of insulin resistance (HOMA-IR) and total cholesterol']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1829779', 'cui_str': 'Homeostasis model assessment'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}]",64.0,0.0357107,"Scores for the Paediatric Quality of Life total scale and physical health and psychosocial health subscale points were increased in experimental and control groups, but the quality of life scale points of the experimental group were higher than the control group.","[{'ForeName': 'Selmin', 'Initials': 'S', 'LastName': 'Köse', 'Affiliation': 'Nursing Department, Faculty of Health Sciences, Biruni University, Istanbul, Turkey.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Yıldız', 'Affiliation': 'Department of Child Health and Diseases Nursing, Florence Nightingale Faculty of Nursing, Istanbul University-Cerrahpasa, Istanbul, Turkey.'}]",International journal of nursing practice,['10.1111/ijn.12878']
2459,32808484,Is Dietary Non-Adherence unique to obesity and weight loss? Results from a randomized clinical trial.,"OBJECTIVE


Weight stigma is associated with poor dietary adherence, yet adherence is essential for weight loss and maintenance. This study aimed to determine differences in dietary adherence and perceived hunger between lean and two groups of individuals with obesity.
METHODS


In a 6-week outpatient dietary intervention (23males; age 48±14), lean participants (n=23; BMI 23±2 kg/m 2  ) received a weight maintaining diet (WMEN) and participants with obesity (BMI 36±7) were randomized to either WMEN (n=18) or 35% calorie reduced (CR) diet (n=19). All food was provided and multiple All food was provided and multiple adherence and hunger ratings were assessed daily and weekly on an outpatient basis and in person at twice weekly visits (e.g. 24h recall, diaries, etc.).
RESULTS


Weight decreased more in individuals with obesity CR group (β=-0.301kg/week, p=0.02) compared to lean and individuals with obesity WMEN groups. However, total percent adherence did not differ between groups (p=0.60) and hunger scores did not change across groups over time (p=0.08).
CONCLUSIONS


Results indicate there are no differences in dietary adherence between lean and individuals with obesity and adherence is not associated with adiposity or hunger. Thus, the belief that non-adherence (e.g. lack of willpower) is unique to obesity is untrue and may perpetuate weight bias and stigma.",2020,"However, total percent adherence did not differ between groups (p=0.60) and hunger scores did not change across groups over time (p=0.08).
","['between lean and two groups of individuals with obesity', '23males; age 48±14), lean participants (n=23; BMI 23±2 kg/m 2  ) received a', 'and participants with obesity (BMI 36±7']","['outpatient dietary intervention', 'weight maintaining diet (WMEN', 'WMEN (n=18) or 35% calorie reduced (CR) diet']","['hunger scores', 'total percent adherence', 'dietary adherence', 'Weight', 'dietary adherence and perceived hunger']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0012167', 'cui_str': 'Weight reduction diet'}]","[{'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0597085,"However, total percent adherence did not differ between groups (p=0.60) and hunger scores did not change across groups over time (p=0.08).
","[{'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Stinson', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA, 85016.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Piaggi', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA, 85016.'}, {'ForeName': 'Susanne B', 'Initials': 'SB', 'LastName': 'Votruba', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA, 85016.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Venti', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA, 85016.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Lovato-Morales', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA, 85016.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Engel', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA, 85016.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Krakoff', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA, 85016.'}, {'ForeName': 'Marci E', 'Initials': 'ME', 'LastName': 'Gluck', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona, USA, 85016.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.23008']
2460,32811637,Treating cannabis use disorder: Exploring a treatment as needed model with 34-month follow-up.,"Research has demonstrated that motivational enhancement (MET) and cognitive behavioral therapy (CBT) are some of the most effective interventions for adults with cannabis use disorder (CUD). As few as two sessions of combined MET and CBT has produced abstinence and reductions in cannabis use greater than delayed treatment controls. Despite their efficacy, outcomes in previous studies yielded abstinence rates from cannabis in the range of 20-30% at follow-ups of 6 to 12 months, and CUD remained a chronic condition for many. Additional models of providing treatment ""as needed"" (PRN), rather than as a single fixed-dose, are necessary to meet the different needs of adults with CUD and reengage those who do not respond to treatment initially or who relapse later. In the current study, 87 adults who met DSM-IV criteria for cannabis dependence were randomly assigned to receive either a fixed-dose of nine sessions of MET/CBT or to a PRN condition that provided a smaller initial dose of treatment, but allowed repeated access to treatment for 28 months. Cannabis use and associated problems were assessed every six months throughout a 34-month period. More than one-third of participants in the PRN condition accessed additional treatment episodes, but the total number of treatment sessions that participants utilized was comparable across conditions. Both treatments yielded significant reductions in cannabis use and associated problems at each follow-up. Contrary to hypotheses, the PRN condition did not yield better outcomes at the longer-term follow-ups. The fixed-dose condition produced greater rates of abstinence at the first follow-up, but otherwise there were no between group differences in outcomes. Future studies should test active approaches to reengaging participants with treatment when initial outcomes are less than optimal.",2020,"The fixed-dose condition produced greater rates of abstinence at the first follow-up, but otherwise there were no between group differences in outcomes.","['87 adults who met DSM-IV criteria for cannabis dependence', 'adults with CUD and reengage those who do not respond to treatment initially or who relapse later', 'adults with cannabis use disorder (CUD', 'Treating cannabis use disorder']","['CBT', 'cognitive behavioral therapy (CBT']","['rates of abstinence', 'abstinence rates', 'cannabis use and associated problems', 'total number of treatment sessions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0006870', 'cui_str': 'Cannabis dependence'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",87.0,0.061929,"The fixed-dose condition produced greater rates of abstinence at the first follow-up, but otherwise there were no between group differences in outcomes.","[{'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Stephens', 'Affiliation': 'Department of Psychology, Virginia Tech, 890 Drillfield Drive, 109 Williams Hall, Blacksburg, VA 24061, United States of America. Electronic address: stephens@vt.edu.'}, {'ForeName': 'Robrina', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'Department of Psychology, Virginia Tech, 890 Drillfield Drive, 109 Williams Hall, Blacksburg, VA 24061, United States of America. Electronic address: robrina.walker@utsouthwestern.edu.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'DeMarce', 'Affiliation': 'Department of Psychology, Virginia Tech, 890 Drillfield Drive, 109 Williams Hall, Blacksburg, VA 24061, United States of America. Electronic address: jdemarce@vt.edu.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Lozano', 'Affiliation': 'Department of Psychology, Virginia Tech, 890 Drillfield Drive, 109 Williams Hall, Blacksburg, VA 24061, United States of America. Electronic address: brian.lozano@va.gov.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Rowland', 'Affiliation': 'Department of Psychology, Virginia Tech, 890 Drillfield Drive, 109 Williams Hall, Blacksburg, VA 24061, United States of America. Electronic address: jared.rowland@va.gov.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Innovative Programs Research Group, School of Social Work, University of Washington, 909 NE 43rd St. Suite 304, Seattle, WA 98105, United States of America. Electronic address: ddwalker@u.washington.edu.'}, {'ForeName': 'Roger A', 'Initials': 'RA', 'LastName': 'Roffman', 'Affiliation': 'Innovative Programs Research Group, School of Social Work, University of Washington, 909 NE 43rd St. Suite 304, Seattle, WA 98105, United States of America. Electronic address: roffman@uw.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108088']
2461,32811664,"Biomechanical analysis of ""Barrel hoop plate"" technique for the posterolateral fragments of tibial plateau fractures with different displacement tendency.","OBJECTIVES


The purpose of our study is to evaluate the three-dimensional biomechanical properties of ""Barrel Hoop plate"" in two kinds of artificial posterolateral tibial plateau fracture fragment (PLF) by using of synthetic models, each of which has an initial amplifying displacement tendency.
MATERIAL AND METHODS


Thirty-six tibiae models were randomly assigned into two groups with different displacement tendencies: posterior displacement (PD) and lateral displacement (LD). Each model was then fixed with three patterns: Anterolateral plate (AP), Posterolateral plate (PP), and ""Barrel Hoop plate"" (BHP). Displacement in three axes of vertical, sagittal and horizontal axis was captured by Optotrak Certus motion analysis system. Bluehill 2 software was used for load control and data collection.
RESULTS


In Model-PD, when the load was over 1000 N, the posterior displacement of Group-PP and Group-BHP were less than Group-AP (P<0.01). The inferior displacement in the vertical axis of Group-PP was larger than both Group-AP and Group-BHP in all the loading set (P<0.01). In Model-LD, both of the lateral displacement in Group-AP and Group-BHP was less than that of Group-PP when the load was over 1000 N (P<0.01). The inferior displacement of Group-AP was less than that of Group-PP in the load of 1500 N (P<0.01). Both of the posterior displacement of Group-AP and Group-BHP was less than that of Group-PP when the loading was 1500 N (P<0.01). The stiffness of Group PP was less than that of Group AP (P<0.01).
CONCLUSIONS


The results demonstrated that the 2.7 mm ""Barrel Hoop plate"" had a greater capacity of anti-three-dimension axes displacement of PLF. The 3.5 mm Anterolateral plate had the advantage in anti-lateral displacement and anti-inferior displacement but was weak at anti-posterior displacement of PLF. The 2.7 mm Posterolateral plate was stronger in anti-posterior, however, weak in anti-inferior displacement capacity.",2020,The inferior displacement in the vertical axis of Group-PP was larger than both Group-AP and Group-BHP in all the loading set (P<0.01).,['Thirty-six tibiae models'],"['artificial posterolateral tibial plateau fracture fragment (PLF', 'Barrel Hoop plate', 'displacement tendencies: posterior displacement (PD) and lateral displacement (LD', 'Anterolateral plate (AP), Posterolateral plate (PP), and ""Barrel Hoop plate"" (BHP', 'Barrel hoop plate"" technique']",['advantage in anti-lateral displacement and anti-inferior displacement'],"[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0262489', 'cui_str': 'Fracture of tibial plateau'}, {'cui': 'C0332255', 'cui_str': 'Fragment of'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C4319631', 'cui_str': 'Barrel'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0333044', 'cui_str': 'Posterior displacement'}, {'cui': 'C0333046', 'cui_str': 'Lateral displacement'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0640001', 'cui_str': 'bicyclo(2.2.1)hept-5-en-2-yl phenyl sulfoxide'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0333046', 'cui_str': 'Lateral displacement'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}]",,0.0199603,The inferior displacement in the vertical axis of Group-PP was larger than both Group-AP and Group-BHP in all the loading set (P<0.01).,"[{'ForeName': 'Bin-Bin', 'Initials': 'BB', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China. Electronic address: binbin_yoyo@163.com.""}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Biomechanical Laboratory, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China. Electronic address: xmhuhai@hotmail.com.""}, {'ForeName': 'Shi', 'Initials': 'S', 'LastName': 'Zhan', 'Affiliation': ""Department of Orthopedic Surgery and Orthopedic Biomechanical Laboratory, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China. Electronic address: zhanshi4890966@yeah.net.""}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Mei', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China. Electronic address: meijiong@163.com.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China. Electronic address: tzjzzy@163.com.""}, {'ForeName': 'Cong-Feng', 'Initials': 'CF', 'LastName': 'Luo', 'Affiliation': ""Department of Orthopaedic Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yishan Road, Shanghai 200233, China. Electronic address: congfengl@outlook.com.""}]",Injury,['10.1016/j.injury.2020.07.059']
2462,32811690,"Corrigendum to ""Influence of front-of-pack labelling and regulated nutrition claims on consumers' perceptions of product healthfulness and purchase intentions: A randomized controlled trial"" [Appetite 149 (1 June 2020) 104629].",,2020,,"[""consumers' perceptions of product healthfulness and purchase intentions""]",['pack labelling and regulated nutrition claims'],[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]","[{'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}]",[],,0.0741049,,"[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Franco-Arellano', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada.""}, {'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Vanderlee', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada; School of Public Health and Health Systems, University of Waterloo, 200 University Avenue West, Waterloo, Ontario, N2L 3G1, Canada.""}, {'ForeName': 'Mavra', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Oh', 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada; Faculty of Law, University of Ottawa, 57 Louis Pasteur St, Ottawa, Ontario, K1N 6N5, Canada.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""L'Abbé"", 'Affiliation': ""Department of Nutritional Sciences, Faculty of Medicine, University of Toronto, Medical Sciences Building, 1 King's College Circle Rm 5368, Toronto, Ontario, M5S 1A8, Canada. Electronic address: mary.labbe@utoronto.ca.""}]",Appetite,['10.1016/j.appet.2020.104809']
2463,32811701,Teaching preschool children correct toothbrushing habits through playful learning interventions: A randomized controlled trial.,"PURPOSE


This study aimed to investigate the effect of playful learning interventions (with toys, visual and auditory sources) on appropriate toothbrushing behaviors and the amount of accumulated plaque in preschool children.
DESIGN AND METHODS


The study was carried out as a parallel-group, randomized and controlled study during the period October-December 2018, with 100 preschool children. The preschool students were randomly assigned to an intervention and a control group. The children in the intervention group were given instructions on how to brush their teeth while the children in the control group were not given any instruction outside of what they had learned in preschool. The playful learning interventions that were carried out consisted of three rounds of meetings designed to educate the children about adopting appropriate toothbrushing behaviors.
RESULTS


The study groups were well matched at baseline (p = .537) and the intervention group showed statistically significant improvements in toothbrushing (p = .001) and plaque control (p = .001) following the intervention in comparison to the controls. Additionally, while the amount of plaque decreased in the children in the intervention group (p = .001), plaque increased in the control group after the intervention (p = .001).
CONCLUSIONS


This study showed that after the playful learning interventions carried out with the preschool children, appropriate toothbrushing behaviors were acquired and there was a decrease in the amount of plaque.
APPLICATION TO PRACTICE


Nurses who work with preschool children could use toys and songs as effective and entertaining nursing interventions for developing correct toothbrushing behaviors.",2020,The study groups were well matched at baseline (p = .537) and the intervention group showed statistically significant improvements in toothbrushing (p = .001) and plaque control (p = .001) following the intervention in comparison to the controls.,"['preschool students', 'Nurses who work with preschool children', 'Teaching preschool children correct toothbrushing habits through playful learning interventions', 'preschool children', 'period October-December 2018, with 100 preschool children']","['playful learning interventions', 'playful learning interventions (with toys, visual and auditory sources']","['plaque control', 'amount of plaque', 'plaque']","[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040565', 'cui_str': 'Toy'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0449416', 'cui_str': 'Source'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",100.0,0.0398742,The study groups were well matched at baseline (p = .537) and the intervention group showed statistically significant improvements in toothbrushing (p = .001) and plaque control (p = .001) following the intervention in comparison to the controls.,"[{'ForeName': 'Deniz Done', 'Initials': 'DD', 'LastName': 'Akkaya', 'Affiliation': 'Department of Pediatric Nursing, Faculty of Health Sciences, Kutahya Health Sciences University, Kutahya, Turkey. Electronic address: denizdone.akkaya@ksbu.edu.tr.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Sezici', 'Affiliation': 'Department of Pediatric Nursing, Faculty of Health Sciences, Kutahya Health Sciences University, Kutahya, Turkey. Electronic address: emel.sezici@ksbu.edu.tr.'}]",Journal of pediatric nursing,['10.1016/j.pedn.2020.08.001']
2464,32811700,Results of an open label feasibility study of sodium valproate in people with McArdle disease.,"McArdle disease results from a lack of muscle glycogen phosphorylase in skeletal muscle tissue. Regenerating skeletal muscle fibres can express the brain glycogen phosphorylase isoenzyme. Stimulating expression of this enzyme could be a therapeutic strategy. Animal model studies indicate that sodium valproate (VPA) can increase expression of phosphorylase in skeletal muscle affected with McArdle disease. This study was designed to assess whether VPA can modify expression of brain phosphorylase isoenzyme in people with McArdle disease. This phase II, open label, feasibility pilot study to assess efficacy of six months treatment with VPA (20 mg/kg/day) included 16 people with McArdle disease. Primary outcome assessed changes in VO 2 peak during an incremental cycle test. Secondary outcomes included: phosphorylase enzyme expression in post-treatment muscle biopsy, total distance walked in 12 min, plasma lactate change (forearm exercise test) and quality of life (SF36). Safety parameters. 14 participants completed the trial, VPA treatment was well tolerated; weight gain was the most frequently reported drug-related adverse event. There was no clinically meaningful change in any of the primary or secondary outcome measures including: VO 2 peak, 12 min walk test and muscle biopsy to look for a change in the number of phosphorylase positive fibres between baseline and 6 months of treatment. Although this was a small open label feasibility study, it suggests that a larger randomised controlled study of VPA, may not be worthwhile.",2020,"There was no clinically meaningful change in any of the primary or secondary outcome measures including: VO 2 peak, 12 min walk test and muscle biopsy to look for a change in the number of phosphorylase positive fibres between baseline and 6 months of treatment.","['16 people with McArdle disease', 'people with McArdle disease']","['VPA', 'sodium valproate (VPA', 'sodium valproate']","['tolerated; weight gain', 'phosphorylase enzyme expression in post-treatment muscle biopsy, total distance walked in 12\xa0min, plasma lactate change (forearm exercise test) and quality of life (SF36', 'VO 2 peak, 12\xa0min walk test and muscle biopsy to look for a change in the number of phosphorylase positive fibres', 'changes in VO 2 peak during an incremental cycle test']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0017924', 'cui_str': 'Glycogen storage disease, type V'}]","[{'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0037567', 'cui_str': 'Valproate sodium'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0017916', 'cui_str': 'alpha-Glucan Phosphorylases'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0016536', 'cui_str': 'Forearm structure'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",16.0,0.0633946,"There was no clinically meaningful change in any of the primary or secondary outcome measures including: VO 2 peak, 12 min walk test and muscle biopsy to look for a change in the number of phosphorylase positive fibres between baseline and 6 months of treatment.","[{'ForeName': 'Renata S', 'Initials': 'RS', 'LastName': 'Scalco', 'Affiliation': 'UCL Institute of Neurology and National Hospital for Neurology and Neurosurgery, Queen Square, United Kingdom; CAPES Foundation, Ministry of Education, Brazil.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Stemmerik', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Nicoline', 'Initials': 'N', 'LastName': 'Løkken', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Christoffer R', 'Initials': 'CR', 'LastName': 'Vissing', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Madsen', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Zuzanna', 'Initials': 'Z', 'LastName': 'Michalak', 'Affiliation': 'UCL Institute of Neurology and National Hospital for Neurology and Neurosurgery, Queen Square, United Kingdom.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Pattni', 'Affiliation': 'UCL Institute of Neurology and National Hospital for Neurology and Neurosurgery, Queen Square, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Godfrey', 'Affiliation': 'UCL Institute of Neurology and National Hospital for Neurology and Neurosurgery, Queen Square, United Kingdom; Centre for Human Performance, Exercise and Rehabilitation, Brunel University London, Uxbridge, United Kingdom.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Samandouras', 'Affiliation': 'UCL Institute of Neurology and National Hospital for Neurology and Neurosurgery, Queen Square, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bassett', 'Affiliation': 'Statsconsultancy Ltd., HP7 9EN, United Kingdom.'}, {'ForeName': 'Janice L', 'Initials': 'JL', 'LastName': 'Holton', 'Affiliation': 'UCL Institute of Neurology and National Hospital for Neurology and Neurosurgery, Queen Square, United Kingdom.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Krag', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Haller', 'Affiliation': 'Department of Neurology, The University of Texas Southwestern Medical Center and Neuromuscular Centre, Institute for exercise and environmental medicine, Dallas, Texas, 75231, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Sewry', 'Affiliation': 'RJAH Orthopaedic Hospital NHS Foundation Trust Oswestry, United Kingdom.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Wigley', 'Affiliation': 'Great Ormond Street Hospital, London, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vissing', 'Affiliation': 'Copenhagen Neuromuscular Center, Department of Neurology, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Ros', 'Initials': 'R', 'LastName': 'Quinlivan', 'Affiliation': 'UCL Institute of Neurology and National Hospital for Neurology and Neurosurgery, Queen Square, United Kingdom. Electronic address: r.quinlivan@ucl.ac.uk.'}]",Neuromuscular disorders : NMD,['10.1016/j.nmd.2020.04.009']
2465,32808403,Combining Frontal Transcranial Direct Current Stimulation With Walking Rehabilitation to Enhance Mobility and Executive Function: A Pilot Clinical Trial.,"OBJECTIVES


This pilot study assessed whether frontal lobe transcranial direct current stimulation (tDCS) combined with complex walking rehabilitation is feasible, safe, and shows preliminary efficacy for improving walking and executive function.
MATERIALS AND METHODS


Participants were randomized to one of the following 18-session interventions: active tDCS and rehabilitation with complex walking tasks (Active/Complex); sham tDCS and rehabilitation with complex walking tasks (Sham/Complex); or sham tDCS and rehabilitation with typical walking (Sham/Typical). Active tDCS was delivered over F3 (cathode) and F4 (anode) scalp locations for 20 min at 2 mA intensity. Outcome measures included tests of walking function, executive function, and prefrontal activity measured by functional near infrared spectroscopy.
RESULTS


Ninety percent of participants completed the intervention protocol successfully. tDCS side effects of tingling or burning sensations were low (average rating less than two out of 10). All groups demonstrated gains in walking performance based on within-group effect sizes (d ≥ 0.50) for one or more assessments. The Sham/Typical group showed the greatest gains for walking based on between-group effect sizes. For executive function, the Active/Complex group showed the greatest gains based on moderate to large between-group effect sizes (d = 0.52-1.11). Functional near-infrared spectroscopy (fNIRS) findings suggest improved prefrontal cortical activity during walking.
CONCLUSIONS


Eighteen sessions of walking rehabilitation combined with tDCS is a feasible and safe intervention for older adults. Preliminary effects size data indicate a potential improvement in executive function by adding frontal tDCS to walking rehabilitation. This study justifies future larger clinical trials to better understand the benefits of combining tDCS with walking rehabilitation.",2020,tDCS side effects of tingling or burning sensations were low (average rating less than two out of 10).,"['Participants', 'older adults']","['active tDCS and rehabilitation with complex walking tasks (Active/Complex); sham tDCS and rehabilitation with complex walking tasks (Sham/Complex); or sham tDCS and rehabilitation with typical walking (Sham/Typical', 'walking rehabilitation combined with tDCS', 'Functional near-infrared spectroscopy (fNIRS', 'frontal lobe transcranial direct current stimulation (tDCS) combined with complex walking rehabilitation', 'Frontal Transcranial Direct Current Stimulation With Walking Rehabilitation']","['executive function', 'tests of walking function, executive function, and prefrontal activity measured by functional near infrared spectroscopy', 'Mobility and Executive Function', 'tDCS side effects of tingling or burning sensations', 'prefrontal cortical activity', 'walking performance']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",,0.0753182,tDCS side effects of tingling or burning sensations were low (average rating less than two out of 10).,"[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Clark', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Sudeshna A', 'Initials': 'SA', 'LastName': 'Chatterjee', 'Affiliation': 'Brain Rehabilitation Research Center, Malcom Randall VA Medical Center, Gainesville, FL, USA.'}, {'ForeName': 'Jared W', 'Initials': 'JW', 'LastName': 'Skinner', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, Malcom Randall VA Medical Center, Gainesville, FL, USA.'}, {'ForeName': 'Paige E', 'Initials': 'PE', 'LastName': 'Lysne', 'Affiliation': 'Department of Aging and Geriatric Research, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Chanoan', 'Initials': 'C', 'LastName': 'Sumonthee', 'Affiliation': 'College of Public Health and Health Professions, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Ronald A', 'Initials': 'RA', 'LastName': 'Cohen', 'Affiliation': 'Department of Clinical and Health Psychology, Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Dorian K', 'Initials': 'DK', 'LastName': 'Rose', 'Affiliation': 'Brain Rehabilitation Research Center, Malcom Randall VA Medical Center, Gainesville, FL, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Woods', 'Affiliation': 'Department of Clinical and Health Psychology, Center for Cognitive Aging and Memory, McKnight Brain Institute, University of Florida, Gainesville, FL, USA.'}]",Neuromodulation : journal of the International Neuromodulation Society,['10.1111/ner.13250']
2466,32808504,"Study of upfront surgery versus neoadjuvant chemotherapy followed by interval debulking surgery for patients with stage IIIC and IV ovarian cancer, SGOG SUNNY (SOC-2) trial concept.","BACKGROUND


Two randomized phase III trials (EORTC55971 and CHORUS) showed similar progression-free and overall survival in primary or interval debulking surgery in ovarian cancer, however both studies had limitations with lower rate of complete resection and lack of surgical qualifications for participating centers. There is no consensus on whether neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS) could be a preferred approach in the management of advanced epithelial ovarian cancer (EOC) in the clinical practice.
METHODS


The Asian SUNNY study is an open-label, multicenter, randomized controlled, phase III trial to compare the effect of primary debulking surgery (PDS) to NACT-IDS in stages IIIC and IV EOC, fallopian tube cancer (FTC) or primary peritoneal carcinoma (PPC). The hypothesis is that PDS enhances the survivorship when compared with NACT-IDS in advanced ovarian cancer. The primary objective is to clarify the role of PDS and NACT-IDS in the treatment of advanced ovarian cancer. Surgical quality assures include at least 50% of no gross residual (NGR) in PDS group in all centers and participating centers should be national cancer centers or designed ovarian cancer section or those with the experience participating surgical trials of ovarian cancer. Any participating center should be monitored evaluating the proportions of NGR by a training set. The aim of the surgery in both arms is maximal cytoreduction. Tumor burden of the disease is evaluated by diagnostic laparoscopy or positron emission tomography/computed tomography scan. Patients assigned to PDS group will undergo upfront maximal cytoreductive surgery within 3 weeks after biopsy, followed by 6 cycles of standard adjuvant chemotherapy. Patients assigned to NACT group will undergo 3 cycles of NACT-IDS, and subsequently 3 cycles of adjuvant chemotherapy. The maximal time interval between IDS and the initiation of adjuvant chemotherapy is 8 weeks. Major inclusion criteria are pathologic confirmed stage IIIC and IV EOC, FTC or PPC; ECOG performance status of 0 to 2; ASA score of 1 to 2. Major exclusion criteria are non-epithelial tumors as well as borderline tumors; low-grade carcinoma; mucinous ovarian cancer. The sample size is 456 subjects. Primary endpoint is overall survival.
TRIAL REGISTRATION


ClinicalTrials.gov Identifier: NCT02859038.",2020,Surgical quality assures include at least 50% of no gross residual (NGR) in PDS group in all centers and participating centers should be national cancer centers or designed ovarian cancer section or those with the experience participating surgical trials of ovarian cancer.,"['in stages IIIC and IV EOC, fallopian tube cancer (FTC) or primary peritoneal carcinoma (PPC', 'patients with stage IIIC and IV ovarian cancer, SGOG SUNNY (SOC-2) trial concept', '456 subjects', 'advanced ovarian cancer']","['primary debulking surgery (PDS) to NACT-IDS', 'PDS and NACT-IDS', 'NACT-IDS', 'upfront maximal cytoreductive surgery', 'neoadjuvant chemotherapy followed by interval debulking surgery (NACT-IDS', 'upfront surgery versus neoadjuvant chemotherapy followed by interval debulking surgery', 'NACT', 'PDS', 'standard adjuvant chemotherapy', 'diagnostic laparoscopy or positron emission tomography/computed tomography scan', 'adjuvant chemotherapy']","['maximal time interval', 'overall survival', 'progression-free and overall survival']","[{'cui': 'C0456608', 'cui_str': 'Stage 3C'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0153579', 'cui_str': 'Malignant tumor of fallopian tube'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0948303', 'cui_str': 'Peritoneal carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.35763,Surgical quality assures include at least 50% of no gross residual (NGR) in PDS group in all centers and participating centers should be national cancer centers or designed ovarian cancer section or those with the experience participating surgical trials of ovarian cancer.,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jianqing', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecologic Oncology, Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jae Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Korean Gynecologic Oncology Group and Department of Obstetrics and Gynecology, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Jihong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Kato', 'Affiliation': 'Japanese Gynecologic Oncology Group and Department of Obstetrics and Gynecology, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Hee Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Korean Gynecologic Oncology Group and Department of Obstetrics and Gynecology, Seoul National University, Seoul, Korea.'}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecologic Oncology, Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecologic Oncology, Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Aoki', 'Affiliation': 'Japanese Gynecologic Oncology Group and Department of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Aijun', 'Initials': 'A', 'LastName': 'Yu', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecologic Oncology, Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.'}, {'ForeName': 'Xipeng', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecology and Obstetrics, Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Zhu', 'Affiliation': ""Shanghai Gynecologic Oncology Group and Department of Gynecology, Hunan Provincial People's Hospital, Changsha, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Biostatistics, School of Public Health, Fudan University, Shanghai, China.'}, {'ForeName': 'Huixun', 'Initials': 'H', 'LastName': 'Jia', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Clinical Statistics Center, Shanghai General Hospital, Shanghai, China.'}, {'ForeName': 'Tingyan', 'Initials': 'T', 'LastName': 'Shi', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Gao', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecologic Oncology, Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Yin', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Libing', 'Initials': 'L', 'LastName': 'Xiang', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China. xianglibing_123@sina.com.'}, {'ForeName': 'Aikou', 'Initials': 'A', 'LastName': 'Okamoto', 'Affiliation': 'Japanese Gynecologic Oncology Group and Department of Obstetrics and Gynecology, The Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Rongyu', 'Initials': 'R', 'LastName': 'Zang', 'Affiliation': 'Shanghai Gynecologic Oncology Group and Ovarian Cancer Program, Division of Gynecology Oncology, Department of Obstetrics and Gynecology, Zhongshan Hospital, Fudan University, Shanghai, China.'}]",Journal of gynecologic oncology,['10.3802/jgo.2020.31.e86']
2467,32808553,The Workplace Support for Health Scale: Reliability and Validity of a Brief Scale to Measure Employee Perceptions of Wellness.,"PURPOSE


To examine the reliability and validity of a brief measure (the Workplace Support for Health [WSH] scale) to assess employees' perceived support for a healthy lifestyle.
DESIGN


Repeated cross-sectional surveys.
SETTING


We collected employer- and employee-level survey data from small, low-wage workplaces in King County, WA enrolled in a randomized controlled trial.
SAMPLE


We analyzed data from 68 workplaces that had 2,820 and 2,640 employees complete surveys at baseline and 15 months, respectively.
MEASURES


The WSH scale consisted of five items. To assess validity, we examined associations between the WSH scale and employer implementation of evidence-based interventions for health promotion, employee self-rated health, and job satisfaction.
ANALYSIS


We performed an exploratory factor analysis to assess the unidimensionality of the WSH scale items, and produced Cronbach's alpha coefficients to examine scale reliability. We ran regression models using generalized estimating equations to examine validity.
RESULTS


The factor analysis indicated one factor, which accounted for 59% of the total variance in the workplace support for health items. The scale had good reliability at baseline (α = 0.82) and 15 months (α = 0.83). Employer evidence-based intervention implementation was positively associated with WSH. WSH was also associated with higher self-rated health and job satisfaction. These associations indicate good concurrent validity.
CONCLUSION


The WSH scale is a reliable and valid measure of perceived workplace support for health. Employers can use the scale to identify gaps in support and create a plan for improvement.",2020,The scale had good reliability at baseline (α = 0.82) and 15 months (α = 0.83).,"['We collected employer- and employee-level survey data from small, low-wage workplaces in King County, WA enrolled', '68 workplaces that had 2,820 and 2,640 employees complete surveys at baseline and 15 months, respectively']",['WSH'],['higher self-rated health and job satisfaction'],"[{'cui': 'C1274022', 'cui_str': 'Employer'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036064', 'cui_str': 'Salaries'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0454792', 'cui_str': 'Offaly'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0022397', 'cui_str': 'Work Satisfaction'}]",,0.0199761,The scale had good reliability at baseline (α = 0.82) and 15 months (α = 0.83).,"[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Kava', 'Affiliation': 'Health Promotion Research Center, Department of Health Services, 7284University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Passey', 'Affiliation': 'Division of Epidemiology, Department of Internal Medicine, 49462University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Harris', 'Affiliation': 'Health Promotion Research Center, Department of Health Services, 7284University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kwun C Gary', 'Initials': 'KCG', 'LastName': 'Chan', 'Affiliation': 'Health Promotion Research Center, Department of Health Services, 7284University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Peggy A', 'Initials': 'PA', 'LastName': 'Hannon', 'Affiliation': 'Health Promotion Research Center, Department of Health Services, 7284University of Washington, Seattle, WA, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120949807']
2468,32808592,Inferior tibiofibular joint mobilization with movement and taping does not improve chronic ankle dorsiflexion stiffness: a randomized placebo-controlled trial.,"OBJECTIVE


This study compared the modification of musculoarticular stiffness (MAS) and clinical outcomes after mobilization with movement (MWM) on the inferior tibiofibular joint and a placebo MWM. Moreover, injured and non-injured ankle MAS were compared after MWM therapy.
METHODS


A single-blinded randomized trial was conducted on 75 participants (mean age: 22.3 ± 2.17 years) with chronic self-reported asymmetric perception of ankle dorsiflexion stiffness. Participants were allocated to one of three groups: inferior tibiofibular MWM (ITFMWM), placebo and non-injured. Sinusoidal oscillation methods were used for experimental quantification of the MAS and clinical outcomes were assessed using the weight-bearing lunge test (WBLT), pain and stiffness perception. Three assessments were made: one pre-treatment (T0), one after the manual technique (T1) and one after taping (T2).
RESULTS


Two-way ANOVA showed no significant differences between the groups and no interaction effect for the outcome measures. However, a significant difference for the time effect (T0-T1-T2) was found in the three groups for WBLT dorsiflexion range of motion (p < 0.001, Cohen's d = 0.21) and stiffness perception (p < 0.001, Cohen's d = 0.54) but the minimal clinically important differences were not reached for either value.
DISCUSSION


The results could not support that a single session of ITFMWM modifies MAS or the clinical outcomes compared to placebo treatment. Furthermore, injured MAS does not differ from non-injured MAS in chronic ankle dorsiflexion stiffness. Further studies should assess subjects' responsiveness concerning the Mulligan concept and focus on a medium- to long-term follow-up.",2020,The results could not support that a single session of ITFMWM modifies MAS or the clinical outcomes compared to placebo treatment.,['75 participants (mean age: 22.3\xa0±\xa02.17\xa0years) with chronic self-reported\xa0asymmetric perception of ankle dorsiflexion stiffness'],"['inferior tibiofibular MWM (ITFMWM), placebo and non-injured', 'mobilization with movement (MWM', 'Inferior tibiofibular joint mobilization with movement and taping', 'placebo']","['time effect (T0-T1-T2', 'weight-bearing\xa0lunge test (WBLT), pain and stiffness perception', 'WBLT dorsiflexion range of motion', 'stiffness perception', 'chronic ankle dorsiflexion stiffness']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517628', 'cui_str': '2.17'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}]","[{'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0730182', 'cui_str': 'Distal tibiofibular joint structure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0231770', 'cui_str': 'Dorsiflexion of foot'}]",75.0,0.0998581,The results could not support that a single session of ITFMWM modifies MAS or the clinical outcomes compared to placebo treatment.,"[{'ForeName': 'Anh Phong', 'Initials': 'AP', 'LastName': 'Nguyen', 'Affiliation': 'Faculté des Sciences de La Motricité, Université Catholique de Louvain , Louvain-La-Neuve, Belgium.'}, {'ForeName': 'Phillipe', 'Initials': 'P', 'LastName': 'Mahaudens', 'Affiliation': 'Faculté des Sciences de La Motricité, Université Catholique de Louvain , Louvain-La-Neuve, Belgium.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Detrembleur', 'Affiliation': 'Faculté des Sciences de La Motricité, Université Catholique de Louvain , Louvain-La-Neuve, Belgium.'}, {'ForeName': 'Toby', 'Initials': 'T', 'LastName': 'Hall', 'Affiliation': 'School of Physiotherapy & Exercise Science, Curtin University , Perth, Australia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hidalgo', 'Affiliation': 'Faculté des Sciences de La Motricité, Université Catholique de Louvain , Louvain-La-Neuve, Belgium.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2020.1805690']
2469,32808600,Effects of a Secondary Prevention Combination Therapy with beta-Blocker and Statin on Major Adverse Cardiovascular Events in Acute Coronary Syndrome Patients.,"BACKGROUND The efficacy of a beta-blocker or statin alone versus combination therapy is uncertain. We compared the effects of a combination of beta-blocker and statin with those of one-drug therapies with regard to the occurrence of a major adverse cardiovascular event (MACE) in patients with acute coronary syndrome (ACS). MATERIAL AND METHODS From 2011 to 2013, 636 ACS patients were included. Based on their risk category, enrolled subjects were assigned into 4 groups receiving consistent beta-blocker and/or statin treatment: no therapy group (n=139), with never use or inconsistent use beta-blocker and statin; beta-blocker monotherapy group (n=71); statin monotherapy group (n=149); and cotherapy group (n=277). RESULTS Men composed 66.8% of the cohort, which had a mean age of 60.42±9.83 years. Compared with the no therapy group, the statin monotherapy group and cotherapy group had a lower risk of MACE (statin monotherapy group: adjusted hazard ratio [HR] 0.35, 95% confidence interval [CI] 0.20-0.60, P<.001; cotherapy group: adjusted HR 0.16, 95% CI 0.09-0.28, P<.001). Subgroup analysis indicated that, compared with beta-blocker monotherapy and statin monotherapy, cotherapy significantly reduced the risks of MACE occurrences in ACS patients (beta-blocker monotherapy group: adjusted HR 0.28, 95% CI 0.13-0.59, P=.001; statin monotherapy group: adjusted HR 0.54, 95% CI 0.29-0.98, P=.044). CONCLUSIONS Beta-blocker and statin combination therapy lowered the risk of developing MACE in ACS patients.",2020,"Compared with the no therapy group, the statin monotherapy group and cotherapy group had a lower risk of MACE (statin monotherapy group: adjusted hazard ratio [HR] 0.35, 95% confidence interval [CI] 0.20-0.60, P<.001; cotherapy group: adjusted HR 0.16, 95% CI 0.09-0.28, P<.001).","['From 2011 to 2013, 636 ACS patients were included', 'patients with acute coronary syndrome (ACS', 'group (n=71', 'Men composed 66.8% of the cohort, which had a mean age of 60.42±9.83 years', 'Acute Coronary Syndrome Patients']","['beta-blocker or statin alone versus combination therapy', 'Secondary Prevention Combination Therapy with beta-Blocker and Statin', 'statin monotherapy', 'beta-blocker and statin', 'cotherapy', 'Beta-blocker and statin combination therapy', 'consistent beta-blocker and/or statin treatment: no therapy group (n=139), with never use or inconsistent use beta-blocker and statin; beta-blocker monotherapy']",['risks of MACE occurrences'],"[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0679699', 'cui_str': 'Secondary prevention'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0442809', 'cui_str': 'Inconsistent'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",636.0,0.0365417,"Compared with the no therapy group, the statin monotherapy group and cotherapy group had a lower risk of MACE (statin monotherapy group: adjusted hazard ratio [HR] 0.35, 95% confidence interval [CI] 0.20-0.60, P<.001; cotherapy group: adjusted HR 0.16, 95% CI 0.09-0.28, P<.001).","[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ""Department of Cardiology, Shaanxi Provincial People's Hospital, Xi'an, Shaanxi, China (mainland).""}, {'ForeName': 'Qianwei', 'Initials': 'Q', 'LastName': 'Cui', 'Affiliation': ""Department of Cardiology, Shaanxi Provincial People's Hospital, Xi'an, Shaanxi, China (mainland).""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Xi'an Medical University, Xi'an, Shaanxi, China (mainland).""}, {'ForeName': 'Zhongwei', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Shaanxi Provincial People's Hospital, Xi'an, Shaanxi, China (mainland).""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, Shaanxi Provincial People's Hospital, Xi'an, Shaanxi, China (mainland).""}, {'ForeName': 'Fuqiang', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Shaanxi Provincial People's Hospital, Xi'an, Shaanxi, China (mainland).""}, {'ForeName': 'Junkui', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Shaanxi Provincial People's Hospital, Xi'an, Shaanxi, China (mainland).""}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.925114']
2470,32808936,Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP): Protocol for a Randomized Clinical Trial to Test a Video-Based Telehealth Intervention.,"BACKGROUND


Despite the introduction of new insulin analogs, insulin pumps, and continuous glucose monitoring (CGM), young children with type 1 diabetes mellitus (T1D) remain vulnerable to episodes of hypoglycemia because of their unpredictable eating and activity patterns and high degree of insulin sensitivity. Caregivers and young children living with T1D learn to fear hypoglycemia because it is uncomfortable, unpredictable, and dangerous. Up to 60% of caregivers of young children with T1D report moderate to severe levels of fear of hypoglycemia, and caregiver fear of hypoglycemia relates to lower quality of life for families and suboptimal child glycemic control. Yet, until recently, there have been no studies reporting on a targeted intervention to treat caregiver fear of hypoglycemia in families of young children.
OBJECTIVE


The aim of this project is to conduct a randomized clinical trial of an innovative, video-based telehealth intervention to treat fear of hypoglycemia in caregivers of young children with T1D versus a relevant, age-appropriate attention control intervention.
METHODS


We created the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention by merging age-appropriate T1D education and behavioral parenting strategies with cognitive behavioral therapy strategies that are effective for reducing fear and promoting adaptive coping. REDCHiP uses 10 video-based telehealth sessions that are a combination of group and individual sessions. We will recruit up to 180 families of young children with T1D to participate in this clinical trial from two pediatric diabetes clinics located in the midwestern and southern United States. Once families have been enrolled, we will randomize caregivers based on child age (age 2-3 years or 4-5 years), child sex, and family CGM use to participate in the REDCHiP or attention control intervention. Families will complete 3 assessment visits that coincide with study entry, end of treatment, and 3-month posttreatment. At each assessment visit, we will collect questionnaire data from caregivers, accelerometry data from caregivers and children, CGM data from children, and a blood sample to measure glycated hemoglobin levels from children.
RESULTS


Recruitment began in July 2019, and enrollment is ongoing. The first wave of intervention delivery began in December 2019. We anticipate completing enrollment in 2023. Final reporting of results will occur within 12 months of the primary completion date.
CONCLUSIONS


If the REDCHiP intervention is efficacious, next steps will be to examine multiple implementation strategies to determine how best to disseminate the intervention to pediatric diabetes clinics around the world.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03914547; https://clinicaltrials.gov/ct2/show/NCT03914547.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/17877.",2020,"Yet, until recently, there have been no studies reporting on a targeted intervention to treat caregiver fear of hypoglycemia in families of young children.
","['Caregivers and young children living with T1D learn to fear hypoglycemia', 'Childhood Hypoglycemia in Parents (REDCHiP', 'caregivers of young children with T1D versus a relevant, age-appropriate attention control intervention', '180 families of young children with T1D to participate in this clinical trial from two pediatric diabetes clinics located in the midwestern and southern United States', 'young children with type 1 diabetes mellitus (T1D', 'randomize caregivers based on child age (age 2-3 years or 4-5 years), child sex, and family CGM use to participate in the REDCHiP or attention control intervention']","['REDCHiP intervention', 'video-based telehealth intervention', 'Childhood Hypoglycemia in Parents (REDCHiP) intervention by merging age-appropriate T1D education and behavioral parenting strategies with cognitive behavioral therapy strategies', 'REDCHiP']","['Emotional Distress', 'severe levels of fear of hypoglycemia, and caregiver fear of hypoglycemia']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C3839636', 'cui_str': 'Diabetes clinic'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1319227', 'cui_str': 'Level of fear'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",,0.0492481,"Yet, until recently, there have been no studies reporting on a targeted intervention to treat caregiver fear of hypoglycemia in families of young children.
","[{'ForeName': 'Susana R', 'Initials': 'SR', 'LastName': 'Patton', 'Affiliation': ""Nemours Children's Health System, Jacksonville, FL, United States.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McConville', 'Affiliation': 'Clinical Child Psychology Program, University of Kansas, Lawrence, KS, United States.'}, {'ForeName': 'Arwen M', 'Initials': 'AM', 'LastName': 'Marker', 'Affiliation': 'Clinical Child Psychology Program, University of Kansas, Lawrence, KS, United States.'}, {'ForeName': 'Alexandra D', 'Initials': 'AD', 'LastName': 'Monzon', 'Affiliation': 'Clinical Child Psychology Program, University of Kansas, Lawrence, KS, United States.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Driscoll', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, United States.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Clements', 'Affiliation': ""Children's Mercy Hospital-Kansas City, Kansas City, MO, United States.""}]",JMIR research protocols,['10.2196/17877']
2471,32809002,"Effect of a Collaborative Care Model on Depressive Symptoms and Glycated Hemoglobin, Blood Pressure, and Serum Cholesterol Among Patients With Depression and Diabetes in India: The INDEPENDENT Randomized Clinical Trial.","Importance


Mental health comorbidities are increasing worldwide and worsen outcomes for people with diabetes, especially when care is fragmented.
Objective


To assess whether collaborative care vs usual care lowers depressive symptoms and improves cardiometabolic indices among adults with diabetes and depression.
Design, Setting, and Participants


Parallel, open-label, pragmatic randomized clinical trial conducted at 4 socioeconomically diverse clinics in India that recruited patients with type 2 diabetes; a Patient Health Questionnaire-9 score of at least 10 (range, 0-27); and hemoglobin A1c (HbA1c) of at least 8%, systolic blood pressure (SBP) of at least 140 mm Hg, or low-density lipoprotein (LDL) cholesterol of at least 130 mg/dL. The first patient was enrolled on March 9, 2015, and the last was enrolled on May 31, 2016; the final follow-up visit was July 14, 2018.
Interventions


Patients randomized to the intervention group (n = 196) received 12 months of self-management support from nonphysician care coordinators, decision support electronic health records facilitating physician treatment adjustments, and specialist case reviews; they were followed up for an additional 12 months without intervention. Patients in the control group (n = 208) received usual care over 24 months.
Main Outcomes and Measures


The primary outcome was the between-group difference in the percentage of patients at 24 months who had at least a 50% reduction in Symptom Checklist Depression Scale (SCL-20) scores (range, 0-4; higher scores indicate worse symptoms) and a reduction of at least 0.5 percentage points in HbA1c, 5 mm Hg in SBP, or 10 mg/dL in LDL cholesterol. Prespecified secondary outcomes were percentage of patients at 12 and 24 months who met treatment targets (HbA1c <7.0%, SBP <130 mm Hg, LDL cholesterol <100 mg/dL [<70 mg/dL if prior cardiovascular disease]) or had improvements in individual outcomes (≥50% reduction in SCL-20 score, ≥0.5-percentage point reduction in HbA1c, ≥5-mm Hg reduction in SBP, ≥10-mg/dL reduction in LDL cholesterol); percentage of patients who met all HbA1c, SBP, and LDL cholesterol targets; and mean reductions in SCL-20 score, Patient Health Questionnaire-9 score, HbA1c, SBP, and LDL cholesterol.
Results


Among 404 patients randomized (mean [SD] age, 53 [8.6] years; 165 [40.8%] men), 378 (93.5%) completed the trial. A significantly greater percentage of patients in the intervention group vs the usual care group met the primary outcome (71.6% vs 57.4%; risk difference, 16.9% [95% CI, 8.5%-25.2%]). Of 16 prespecified secondary outcomes, there were no statistically significant between-group differences in improvements in 10 outcomes at 12 months and in 13 outcomes at 24 months. Serious adverse events in the intervention and usual care groups included cardiovascular events or hospitalizations (4 [2.0%] vs 7 [3.4%]), stroke (0 vs 3 [1.4%]), death (2 [1.0%] vs 7 [3.4%]), and severe hypoglycemia (8 [4.1%] vs 0).
Conclusions and Relevance


Among patients with diabetes and depression in India, a 12-month collaborative care intervention, compared with usual care, resulted in statistically significant improvements in a composite measure of depressive symptoms and cardiometabolic indices at 24 months. Further research is needed to understand the generalizability of the findings to other low- and middle-income health care settings.
Trial Registration


ClinicalTrials.gov Identifier: NCT02022111.",2020,"A significantly greater percentage of patients in the intervention group vs the usual care group met the primary outcome (71.6% vs 57.4%; risk difference, 16.9% [95% CI, 8.5%-25.2%]).","['adults with diabetes and depression', 'Patients With Depression and Diabetes in India', 'people with diabetes', 'patients with diabetes and depression in India', '404 patients randomized (mean [SD] age, 53 [8.6] years; 165 [40.8%] men), 378 (93.5%) completed the trial', '4 socioeconomically diverse clinics in India that recruited patients with type 2 diabetes; a Patient Health Questionnaire-9 score of at least 10 (range,\u20090-27); and hemoglobin A1c (HbA1c) of at least 8%, systolic blood pressure (SBP) of at least 140 mm Hg, or low-density lipoprotein (LDL) cholesterol of at least 130 mg/dL. The first patient was enrolled on March 9, 2015, and the last was enrolled on May 31, 2016; the final follow-up visit was July 14, 2018']","['intervention group (n\u2009=\u2009196) received 12 months of self-management support from nonphysician care coordinators, decision support electronic health records facilitating physician treatment adjustments, and specialist case reviews; they were followed up for an additional 12 months without intervention', 'usual care over 24 months', 'collaborative care vs usual care', 'Collaborative Care Model']","['severe hypoglycemia', 'Depressive Symptoms and Glycated Hemoglobin, Blood Pressure, and Serum Cholesterol', 'cardiovascular events or hospitalizations', 'Hg reduction in SBP, ≥10-mg/dL reduction in LDL cholesterol', 'SCL-20 score, ≥0.5-percentage point reduction in HbA1c, ≥5-mm', 'death', 'stroke', 'cardiometabolic indices', 'depressive symptoms and cardiometabolic indices', 'SBP <130 mm Hg, LDL cholesterol', 'SCL-20 score, Patient Health Questionnaire-9 score, HbA1c, SBP, and LDL cholesterol', 'Symptom Checklist Depression Scale (SCL-20) scores', 'Serious adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C4708569', 'cui_str': 'Care coordinator'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332288', 'cui_str': 'Without'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0587184', 'cui_str': 'Serum cholesterol measurement'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0378781', 'cui_str': 'Oncogene protein TAL 1'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",404.0,0.155763,"A significantly greater percentage of patients in the intervention group vs the usual care group met the primary outcome (71.6% vs 57.4%; risk difference, 16.9% [95% CI, 8.5%-25.2%]).","[{'ForeName': 'Mohammed K', 'Initials': 'MK', 'LastName': 'Ali', 'Affiliation': 'Hubert Department of Global Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Chwastiak', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle.'}, {'ForeName': 'Subramani', 'Initials': 'S', 'LastName': 'Poongothai', 'Affiliation': 'Madras Diabetes Research Foundation, Chennai, India.'}, {'ForeName': 'Karl M F', 'Initials': 'KMF', 'LastName': 'Emmert-Fees', 'Affiliation': 'Hubert Department of Global Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Shivani A', 'Initials': 'SA', 'LastName': 'Patel', 'Affiliation': 'Hubert Department of Global Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Ranjit Mohan', 'Initials': 'RM', 'LastName': 'Anjana', 'Affiliation': 'Madras Diabetes Research Foundation, Chennai, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Sagar', 'Affiliation': 'Department of Psychiatry, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'Radha', 'Initials': 'R', 'LastName': 'Shankar', 'Affiliation': 'Madras Diabetes Research Foundation, Chennai, India.'}, {'ForeName': 'Gumpeny R', 'Initials': 'GR', 'LastName': 'Sridhar', 'Affiliation': 'Endocrine and Diabetes Centre, Visakhapatnam, India.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Kosuri', 'Affiliation': 'Department of Psychology, Andhra University, Visakhapatnam, India.'}, {'ForeName': 'Aravind R', 'Initials': 'AR', 'LastName': 'Sosale', 'Affiliation': 'Diacon Hospital, Diabetes Care and Research Center, Bangalore, India.'}, {'ForeName': 'Bhavana', 'Initials': 'B', 'LastName': 'Sosale', 'Affiliation': 'Diacon Hospital, Diabetes Care and Research Center, Bangalore, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Rao', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Tandon', 'Affiliation': 'Endocrinology & Metabolism, All India Institute of Medical Sciences, Delhi, India.'}, {'ForeName': 'K M Venkat', 'Initials': 'KMV', 'LastName': 'Narayan', 'Affiliation': 'Hubert Department of Global Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Mohan', 'Affiliation': 'Madras Diabetes Research Foundation, Chennai, India.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.11747']
2472,32809003,"Effect of Ascorbic Acid, Corticosteroids, and Thiamine on Organ Injury in Septic Shock: The ACTS Randomized Clinical Trial.","Importance


The combination of ascorbic acid, corticosteroids, and thiamine has been identified as a potential therapy for septic shock.
Objective


To determine whether the combination of ascorbic acid, corticosteroids, and thiamine attenuates organ injury in patients with septic shock.
Design, Setting, and Participants


Randomized, blinded, multicenter clinical trial of ascorbic acid, corticosteroids, and thiamine vs placebo for adult patients with septic shock. Two hundred five patients were enrolled between February 9, 2018, and October 27, 2019, at 14 centers in the United States. Follow-up continued until November 26, 2019.
Interventions


Patients were randomly assigned to receive parenteral ascorbic acid (1500 mg), hydrocortisone (50 mg), and thiamine (100 mg) every 6 hours for 4 days (n = 103) or placebo in matching volumes at the same time points (n = 102).
Main Outcomes and Measures


The primary outcome was change in the Sequential Organ Failure Assessment (SOFA) score (range, 0-24; 0 = best) between enrollment and 72 hours. Key secondary outcomes included kidney failure and 30-day mortality. Patients who received at least 1 dose of study drug were included in analyses.
Results


Among 205 randomized patients (mean age, 68 [SD, 15] years; 90 [44%] women), 200 (98%) received at least 1 dose of study drug, completed the trial, and were included in the analyses (101 with intervention and 99 with placebo group). Overall, there was no statistically significant interaction between time and treatment group with regard to SOFA score over the 72 hours after enrollment (mean SOFA score change from 9.1 to 4.4 [-4.7] points with intervention vs 9.2 to 5.1 [-4.1] points with placebo; adjusted mean difference, -0.8; 95% CI, -1.7 to 0.2; P = .12 for interaction). There was no statistically significant difference in the incidence of kidney failure (31.7% with intervention vs 27.3% with placebo; adjusted risk difference, 0.03; 95% CI, -0.1 to 0.2; P = .58) or in 30-day mortality (34.7% vs 29.3%, respectively; hazard ratio, 1.3; 95% CI, 0.8-2.2; P = .26). The most common serious adverse events were hyperglycemia (12 patients with intervention and 7 patients with placebo), hypernatremia (11 and 7 patients, respectively), and new hospital-acquired infection (13 and 12 patients, respectively).
Conclusions and Relevance


In patients with septic shock, the combination of ascorbic acid, corticosteroids, and thiamine, compared with placebo, did not result in a statistically significant reduction in SOFA score during the first 72 hours after enrollment. These data do not support routine use of this combination therapy for patients with septic shock.
Trial Registration


ClinicalTrials.gov Identifier: NCT03389555.",2020,"Overall, there was no statistically significant interaction between time and treatment group with regard to SOFA score over the 72 hours after enrollment (mean SOFA score change from 9.1 to 4.4 [-4.7] points with intervention vs 9.2 to 5.1","['Patients who received at least 1 dose of study drug were included in analyses', 'patients with septic shock', '205 randomized patients (mean age, 68 [SD, 15] years', 'adult patients with septic shock', 'Two hundred five patients were enrolled between February 9, 2018, and October 27, 2019, at 14 centers in the United States', 'Septic Shock', '90 [44%] women), 200 (98%) received at least 1 dose of study drug, completed the trial, and were included in the analyses (101 with intervention and 99 with placebo group']","['ascorbic acid, corticosteroids, and thiamine', 'Ascorbic Acid, Corticosteroids, and Thiamine', 'hydrocortisone (50 mg), and thiamine', 'parenteral ascorbic acid', 'ascorbic acid, corticosteroids, and thiamine vs placebo', 'placebo']","['Sequential Organ Failure Assessment (SOFA) score', 'new hospital-acquired infection', 'kidney failure and 30-day mortality', '30-day mortality', 'incidence of kidney failure', 'SOFA score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205721', 'cui_str': 'Nosocomial infection'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}]",205.0,0.79798,"Overall, there was no statistically significant interaction between time and treatment group with regard to SOFA score over the 72 hours after enrollment (mean SOFA score change from 9.1 to 4.4 [-4.7] points with intervention vs 9.2 to 5.1","[{'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Moskowitz', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Huang', 'Affiliation': 'Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Hou', 'Affiliation': ""Division of Emergency Critical Care Medicine, Department of Emergency Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Department of Emergency Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York.'}, {'ForeName': 'Pratik B', 'Initials': 'PB', 'LastName': 'Doshi', 'Affiliation': 'Department of Emergency Medicine, McGovern Medical School at UTHealth, Houston, Texas.'}, {'ForeName': 'Anne V', 'Initials': 'AV', 'LastName': 'Grossestreuer', 'Affiliation': 'Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Lars W', 'Initials': 'LW', 'LastName': 'Andersen', 'Affiliation': 'Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Ngo', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Sherwin', 'Affiliation': 'Sinai Grace Hospital, Department of Emergency Medicine, Wayne State University School of Medicine, Detroit, Michigan.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Berg', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Chase', 'Affiliation': 'Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Cocchi', 'Affiliation': 'Center for Resuscitation Science, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jessica B', 'Initials': 'JB', 'LastName': 'McCannon', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Mount Auburn Hospital, Cambridge, Massachusetts.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hershey', 'Affiliation': 'Division of Critical Care Medicine, South Shore Hospital, Weymouth, Massachusetts.'}, {'ForeName': 'Ayelet', 'Initials': 'A', 'LastName': 'Hilewitz', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York.'}, {'ForeName': 'Maksim', 'Initials': 'M', 'LastName': 'Korotun', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York.'}, {'ForeName': 'Lance B', 'Initials': 'LB', 'LastName': 'Becker', 'Affiliation': 'Department of Emergency Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York.'}, {'ForeName': 'Ronny M', 'Initials': 'RM', 'LastName': 'Otero', 'Affiliation': 'Beaumont Hospital, Department of Emergency Medicine, Oakland University William Beaumont School of Medicine, Beaumont, Michigan.'}, {'ForeName': 'Junior', 'Initials': 'J', 'LastName': 'Uduman', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Division of Nephrology and Hypertension, Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'Ayan', 'Initials': 'A', 'LastName': 'Sen', 'Affiliation': 'Department of Critical Care Medicine, Mayo Clinic, Phoenix, Arizona.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Donnino', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.11946']
2473,32809014,Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS): Bayesian Adaptive Comparative Effectiveness Randomized Trial.,"Importance


Cryptogenic sensory polyneuropathy (CSPN) is a common generalized slowly progressive neuropathy, second in prevalence only to diabetic neuropathy. Most patients with CSPN have significant pain. Many medications have been tried for pain reduction in CSPN, including antiepileptics, antidepressants, and sodium channel blockers. There are no comparative studies that identify the most effective medication for pain reduction in CSPN.
Objective


To determine which medication (pregabalin, duloxetine, nortriptyline, or mexiletine) is most effective for reducing neuropathic pain and best tolerated in patients with CSPN.
Design, Setting, and Participants


From December 1, 2014, through October 20, 2017, a bayesian adaptive, open-label randomized clinical comparative effectiveness study of pain in 402 participants with CSPN was conducted at 40 neurology care clinics. The trial included response adaptive randomization. Participants were patients with CSPN who were 30 years or older, with a pain score of 4 or greater on a numerical rating scale (range, 0-10, with higher scores indicating a higher level of pain). Participant allocation to 1 of 4 drug groups used the utility function and treatment's sample size for response adaptation randomization. At each interim analysis, a decision was made to continue enrolling (up to 400 participants) or stop the whole trial for success (80% power). Patient engagement was maintained throughout the trial, which helped guide the study and identify ways to communicate and disseminate information. Analysis was performed from December 11, 2015, to January 19, 2018.
Interventions


Participants were randomized to receive nortriptyline (n = 134), duloxetine (n = 126), pregabalin (n = 73), or mexiletine (n = 69).
Main Outcomes and Measures


The primary outcome was a utility function that was a composite of the efficacy (participant reported pain reduction of ≥50% from baseline to week 12) and quit (participants who discontinued medication) rates.
Results


Among the 402 participants (213 men [53.0%]; mean [SD] age, 60.1 [13.4] years; 343 White [85.3%]), the utility function of nortriptyline was 0.81 (95% bayesian credible interval [CrI], 0.69-0.93; 34 of 134 [25.4%] efficacious; and 51 of 134 [38.1%] quit), of duloxetine was 0.80 (95% CrI, 0.68-0.92; 29 of 126 [23.0%] efficacious; and 47 of 126 [37.3%] quit), pregabalin was 0.69 (95% CrI, 0.55-0.84; 11 of 73 [15.1%] efficacious; and 31 of 73 [42.5%] quit), and mexiletine was 0.58 (95% CrI, 0.42-0.75; 14 of 69 [20.3%] efficacious; and 40 of 69 [58.0%] quit). The probability each medication yielded the highest utility was 0.52 for nortriptyline, 0.43 for duloxetine, 0.05 for pregabalin, and 0.00 for mexiletine.
Conclusions and Relevance


This study found that, although there was no clearly superior medication, nortriptyline and duloxetine outperformed pregabalin and mexiletine when pain reduction and undesirable adverse effects are combined to a single end point.
Trial Registration


ClinicalTrials.gov Identifier: NCT02260388.",2020,"The probability each medication yielded the highest utility was 0.52 for nortriptyline, 0.43 for duloxetine, 0.05 for pregabalin, and 0.00 for mexiletine.
","['Real Life Situations (PAIN-CONTRoLS', '402 participants (213 men [53.0%]; mean [SD] age, 60.1 [13.4] years; 343 White [85.3', 'patients with CSPN', '402 participants with CSPN was conducted at 40 neurology care clinics', 'Participants were patients with CSPN who were 30 years or older, with a pain score of 4 or greater on a numerical rating scale (range, 0-10, with higher scores indicating a higher level of pain']","['mexiletine', 'nortriptyline', 'duloxetine', 'pregabalin', 'medication (pregabalin, duloxetine, nortriptyline, or mexiletine']","['neuropathic pain and best tolerated', 'utility function that was a composite of the efficacy (participant reported pain reduction', 'pain reduction and undesirable adverse effects', 'pain']","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0271681', 'cui_str': 'Sensory polyneuropathy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0025887', 'cui_str': 'Mexiletine'}, {'cui': 'C0028420', 'cui_str': 'Nortriptyline'}, {'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",402.0,0.150063,"The probability each medication yielded the highest utility was 0.52 for nortriptyline, 0.43 for duloxetine, 0.05 for pregabalin, and 0.00 for mexiletine.
","[{'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Barohn', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Gajewski', 'Affiliation': 'Department of Biostatistics & Data Science, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Mamatha', 'Initials': 'M', 'LastName': 'Pasnoor', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Brown', 'Affiliation': 'Department of Biostatistics & Data Science, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Herbelin', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Kim S', 'Initials': 'KS', 'LastName': 'Kimminau', 'Affiliation': 'Department of Family Medicine, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Dinesh Pal', 'Initials': 'DP', 'LastName': 'Mudaranthakam', 'Affiliation': 'Department of Biostatistics & Data Science, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Jawdat', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Mazen M', 'Initials': 'MM', 'LastName': 'Dimachkie', 'Affiliation': 'Department of Neurology, The University of Kansas Medical Center, Kansas City.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Iyadurai', 'Affiliation': 'The Ohio State University, Columbus.'}, {'ForeName': 'Amro', 'Initials': 'A', 'LastName': 'Stino', 'Affiliation': 'The Ohio State University, Columbus.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kissel', 'Affiliation': 'The Ohio State University, Columbus.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pascuzzi', 'Affiliation': 'Indiana University, Bloomington, Indiana.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Brannagan', 'Affiliation': 'Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Wicklund', 'Affiliation': 'Pennsylvania State University, Centre County.'}, {'ForeName': 'Aiesha', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Pennsylvania State University, Centre County.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Walk', 'Affiliation': 'University of Minnesota, Minneapolis.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Dianna', 'Initials': 'D', 'LastName': 'Quan', 'Affiliation': 'University of Colorado-Denver, Denver.'}, {'ForeName': 'Darryl', 'Initials': 'D', 'LastName': 'Heitzman', 'Affiliation': 'Texas Neurology, Dallas.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Tobon', 'Affiliation': 'UT Health Science-San Antonio, San Antonio, Texas.'}, {'ForeName': 'Shafeeq', 'Initials': 'S', 'LastName': 'Ladha', 'Affiliation': 'Barrow Neurology, Phoenix, Arizona.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Wolfe', 'Affiliation': 'University at Buffalo, Buffalo, New York.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pulley', 'Affiliation': 'University of Florida Jacksonville, Jacksonville.'}, {'ForeName': 'Ghazala', 'Initials': 'G', 'LastName': 'Hayat', 'Affiliation': 'Saint Louis University, St Louis, Missouri.'}, {'ForeName': 'Yuebing', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Pariwat', 'Initials': 'P', 'LastName': 'Thaisetthawatkul', 'Affiliation': 'University of Nebraska Medical Center, Omaha.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Suur', 'Initials': 'S', 'LastName': 'Biliciler', 'Affiliation': 'University of Texas Health Science Center at Houston.'}, {'ForeName': 'Khema', 'Initials': 'K', 'LastName': 'Sharma', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Kian', 'Initials': 'K', 'LastName': 'Salajegheh', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Trivedi', 'Affiliation': 'UT Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Mallonee', 'Affiliation': 'Hutchinson Clinic, Hutchinson, Kansas.'}, {'ForeName': 'Ted', 'Initials': 'T', 'LastName': 'Burns', 'Affiliation': 'University of Virginia, Charlottesville.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jacoby', 'Affiliation': 'Mercy Medical Center, Des Moines, Iowa.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Bril', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Tuan', 'Initials': 'T', 'LastName': 'Vu', 'Affiliation': 'University of South Florida-Tampa, Tampa.'}, {'ForeName': 'Sindhu', 'Initials': 'S', 'LastName': 'Ramchandren', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bazant', 'Affiliation': 'Norton Neurology Services, Louisville, Kentucky.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Austin', 'Affiliation': 'Seton Brain and Spine, Austin, Texas.'}, {'ForeName': 'Chafic', 'Initials': 'C', 'LastName': 'Karam', 'Affiliation': 'Oregon Health and Science University, Portland.'}, {'ForeName': 'Yessar', 'Initials': 'Y', 'LastName': 'Hussain', 'Affiliation': 'Austin Neuromuscular Center, Austin, Texas.'}, {'ForeName': 'Christen', 'Initials': 'C', 'LastName': 'Kutz', 'Affiliation': 'Colorado Springs Neurological Associates, Colorado Springs.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Twydell', 'Affiliation': 'Spectrum Health, Grand Rapids, Michigan.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Scelsa', 'Affiliation': 'Mt Sinai Beth Israel, New York, New York.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Kushlaf', 'Affiliation': 'University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wymer', 'Affiliation': 'University of Florida-Gainesville, Gainesville.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hehir', 'Affiliation': 'University of Vermont, Burlington.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Kolb', 'Affiliation': 'University of Vermont, Burlington.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Ralph', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Barboi', 'Affiliation': 'NorthShore University Health System, Evanston, Illinois.'}, {'ForeName': 'Navin', 'Initials': 'N', 'LastName': 'Verma', 'Affiliation': 'Neurological Services of Orlando Research, Orlando, Florida.'}, {'ForeName': 'Moiz', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'Grand Medical Clinic, Katy, Texas.'}, {'ForeName': 'Anza', 'Initials': 'A', 'LastName': 'Memon', 'Affiliation': 'Henry Ford Hospital, Detroit, Michigan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Saperstein', 'Affiliation': 'Phoenix Neurological, Phoenix, Arizona.'}, {'ForeName': 'Jau-Shin', 'Initials': 'JS', 'LastName': 'Lou', 'Affiliation': 'University of North Dakota, Grand Forks.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Swenson', 'Affiliation': 'University of Iowa Hospitals and Clinics, Iowa City.'}, {'ForeName': 'Tiyonnoh', 'Initials': 'T', 'LastName': 'Cash', 'Affiliation': 'University of California-Irvine, Irvine.'}]",JAMA neurology,['10.1001/jamaneurol.2020.2590']
2474,31456039,Anxious depression as a clinically relevant subtype of pediatric major depressive disorder.,"In adults, anxious depression has been identified as a more severe form of major depressive disorder (MDD), associated with higher depression severity, more suicidal ideation and worse treatment outcome. Research in pediatric depression, however, has been sparse. 126 children and adolescents aged 8-18 years with a primary diagnosis of MDD were categorized into a MDD-only group and an anxious depression group based on clinically elevated scores on the Beck Anxiety Inventory. One-third of the sample was classified as having anxious depression with females being overrepresented in the anxious depressed compared to the MDD-only group. 42.2% of the anxious depressed youth met diagnostic criteria for a comorbid anxiety disorder. Anxious depressed youth were more likely to suffer recurrent depressive episodes, showed higher depression severity and a unique pattern of depressive symptoms characterized by more severe sleep problems, more somatic complaints, more severely depressed mood and more frequent suicidal ideations. Scores on a suicidal ideation scale were increased even when controlling for overall depression severity. However, when comparing depressed patients with and without comorbid anxiety disorders, no differences in depression severity, symptom patterns or suicidal ideations were observed. The results indicate that high anxiety levels in depressed youth are clinically relevant, and given the increase in suicidal ideation, anxiety symptoms during depressive episodes should routinely be screened in clinical practice even in the absence of a fully formed comorbid anxiety disorder.",2019,"Anxious depressed youth were more likely to suffer recurrent depressive episodes, showed higher depression severity and a unique pattern of depressive symptoms characterized by more severe sleep problems, more somatic complaints, more severely depressed mood and more frequent suicidal ideations.",['126 children and adolescents aged 8-18\xa0years with a primary diagnosis of MDD were categorized into a MDD-only group and an anxious depression group based on clinically elevated scores on the Beck Anxiety Inventory'],[],"['suicidal ideation scale', 'depression severity, symptom patterns or suicidal ideations', 'severe sleep problems', 'Anxious depression', 'suicidal ideation, anxiety symptoms', 'somatic complaints', 'frequent suicidal ideations']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0582613', 'cui_str': 'Beck anxiety inventory'}]",[],"[{'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0436318', 'cui_str': 'Symptom pattern'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnia'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}]",126.0,0.0213554,"Anxious depressed youth were more likely to suffer recurrent depressive episodes, showed higher depression severity and a unique pattern of depressive symptoms characterized by more severe sleep problems, more somatic complaints, more severely depressed mood and more frequent suicidal ideations.","[{'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Häberling', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Psychiatric Hospital, University of Zurich, Zurich, Switzerland. isabelle.haeberling@uzh.ch.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Baumgartner', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Emery', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Keller', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Strumberger', 'Affiliation': 'Research Department of Child and Adolescent Psychiatry, Psychiatric University Hospitals Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Nalani', 'Affiliation': 'Clinic for Psychosomatic Medicine and Psychiatry, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Schmeck', 'Affiliation': 'Research Department of Child and Adolescent Psychiatry, Psychiatric University Hospitals Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Erb', 'Affiliation': 'Child and Adolescent Psychiatric Services St. Gallen, St. Gallen, Switzerland.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Bachmann', 'Affiliation': 'Clienia Littenheid AG, Littenheid, Switzerland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wöckel', 'Affiliation': 'Research Department of Child and Adolescent Psychiatry, Psychiatric University Hospitals Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Müller-Knapp', 'Affiliation': 'Child and Adolescent Psychiatry Klinik Sonnenhof, Ganterschwil, Switzerland.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Contin-Waldvogel', 'Affiliation': 'Child and Adolescent Psychiatric Services Baselland, Liestal, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Rhiner', 'Affiliation': 'Child and Adolescent Psychiatric Services Thurgau, Weinfelden, Switzerland.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Walitza', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Berger', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, Psychiatric Hospital, University of Zurich, Zurich, Switzerland.'}]","Journal of neural transmission (Vienna, Austria : 1996)",['10.1007/s00702-019-02069-x']
2475,31535460,Wheat Protein Hydrolysate Fortified With l-Arginine Enhances Satiation Induced by the Capsaicinoid Nonivamide in Moderately Overweight Male Subjects.,"SCOPE


Increasing the intake of satiety-enhancing food compounds represents a promising strategy for maintaining a healthy body weight. Recently, satiating effects for the capsaicinoid nonivamide have been demonstrated. As various proteins and amino acids have also been demonstrated to decrease energy intake, oral glucose tolerance test (oGTT)-based bolus interventions of 75 g glucose + 0.15 mg nonivamide (NV control) are tested with/without combination of a wheat protein hydrolysate (WPH: 2 g) and/or l-arginine (ARG: 3.2 g) for their satiating effects in 27 moderately overweight male subjects.
METHODS AND RESULTS


Compared to NV control intervention, ARG and WPH + ARG treatment both reduce (p < 0.01) total calorie intake from a standardized breakfast by -5.9 ± 4.15% and -6.07 ± 4.38%, respectively. For the WPH + ARG intervention, increased mean plasma serotonin concentrations (AUC: 350 ± 218), quantitated by ELISA, and delayed gastric emptying, assessed by  13  C-Na-acetate breath test (-2.10 ± 0.51%, p < 0.05), are demonstrated compared to NV control. Correlation analysis between plasma serotonin and gastric emptying reveals a significant association after WPH ± ARG intervention (r = -0.396, p = 0.045).
CONCLUSION


Combination of WPH and ARG enhances the satiating effect of nonivamide, providing opportunities to optimize satiating food formulations by low amounts of the individual food constituents.",2019,"Compared to NV control intervention, ARG and WPH + ARG treatment both reduce (p < 0.01) total calorie intake from a standardized breakfast by -5.9 ± 4.15% and -6.07 ± 4.38%, respectively.","['27 moderately overweight male subjects', 'Moderately Overweight Male Subjects']","['wheat protein hydrolysate (WPH', 'l-arginine (ARG', 'Wheat Protein Hydrolysate Fortified With l-Arginine', 'ARG intervention']","['total calorie intake', 'mean plasma serotonin concentrations (AUC: 350\xa0±\xa0218), quantitated by ELISA, and delayed gastric emptying, assessed by  13  C-Na-acetate breath test']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0033631', 'cui_str': 'protein hydrolysates'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0152020', 'cui_str': 'Gastroparesis syndrome'}, {'cui': 'C0729631', 'cui_str': 'Carbon-13'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0006153', 'cui_str': 'Breath test'}]",,0.0182041,"Compared to NV control intervention, ARG and WPH + ARG treatment both reduce (p < 0.01) total calorie intake from a standardized breakfast by -5.9 ± 4.15% and -6.07 ± 4.38%, respectively.","[{'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Stoeger', 'Affiliation': 'Christian Doppler Laboratory for Bioactive Compounds, Althanstrasse 14 (UZA II), Vienna, 1090, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Lieder', 'Affiliation': 'Department of Physiological Chemistry, University of Vienna, Althanstrasse 14 (UZA II), Vienna, 1090, Austria.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Riedel', 'Affiliation': 'Department of Physiological Chemistry, University of Vienna, Althanstrasse 14 (UZA II), Vienna, 1090, Austria.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Schweiger', 'Affiliation': 'Department of Physiological Chemistry, University of Vienna, Althanstrasse 14 (UZA II), Vienna, 1090, Austria.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Hoi', 'Affiliation': 'Christian Doppler Laboratory for Bioactive Compounds, Althanstrasse 14 (UZA II), Vienna, 1090, Austria.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Ruzsanyi', 'Affiliation': 'Institute for Breath Research, University of Innsbruck, Innrain 66, Innsbruck, 6020, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Klieber', 'Affiliation': 'Institute for Breath Research, University of Innsbruck, Innrain 66, Innsbruck, 6020, Austria.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Rust', 'Affiliation': 'Department of Nutritional Sciences, University of Vienna, Althanstrasse 14 (UZA II), Vienna, 1090, Austria.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Hans', 'Affiliation': 'Symrise AG, Research & Technology Flavors Division, 37603, Holzminden, Germany.'}, {'ForeName': 'Jakob P', 'Initials': 'JP', 'LastName': 'Ley', 'Affiliation': 'Symrise AG, Research & Technology Flavors Division, 37603, Holzminden, Germany.'}, {'ForeName': 'Gerhard E', 'Initials': 'GE', 'LastName': 'Krammer', 'Affiliation': 'Symrise AG, Research & Technology Flavors Division, 37603, Holzminden, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Somoza', 'Affiliation': 'Department of Physiological Chemistry, University of Vienna, Althanstrasse 14 (UZA II), Vienna, 1090, Austria.'}]",Molecular nutrition & food research,['10.1002/mnfr.201900133']
2476,30738699,Frontal slow wave resting EEG power is higher in individuals at Ultra High Risk for psychosis than in healthy controls but is not associated with negative symptoms or functioning.,"Decreased brain activity in the frontal region, as indicated by increased slow wave EEG power measured by electrodes place on the skull over this area, in association with negative symptoms has previously been shown to distinguish ultra-high risk (UHR) individuals who later transitioned to psychosis (UHR-P) from those who did not transition (UHR-NP). The aims of the current study were to: 1) replicate these results and 2) investigate whether similar association between increased frontal slow wave activity and functioning shows any value in the prediction of transition to psychosis in UHR individuals. The brain activity, recorded using EEG, of 44 UHR individuals and 38 healthy controls was included in the analyses. Symptom severity was assessed in UHR participants and functioning was measured in both groups. The power in the theta frequency band in the frontal region of UHR individuals was higher than in controls. However, there was no difference between the UHR-P and the UHR-NP groups, and no change in slow frequency power following transition to psychosis. The correlation between delta frequency power and negative symptoms previously observed was not present in our UHR cohort, and there was no association between frontal delta or theta and functioning in either group. Increased delta power was rather correlated with depressive symptoms in the UHR group. Future research will be needed to better understand when, in the course of the illness, does the slow wave activity in the frontal area becomes impaired.",2019,"Decreased brain activity in the frontal region, as indicated by increased slow wave EEG power measured by electrodes place on the skull over this area, in association with negative symptoms has previously been shown to distinguish ultra-high risk (UHR) individuals who later transitioned to psychosis (UHR-P) from those who did not transition (UHR-NP).","['44 UHR individuals and 38 healthy controls was included in the analyses', 'UHR individuals']",[],"['Symptom severity', 'Decreased brain activity', 'slow wave EEG power', 'Increased delta power', 'depressive symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",[],"[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0858603', 'cui_str': 'Wave slowing'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0365993,"Decreased brain activity in the frontal region, as indicated by increased slow wave EEG power measured by electrodes place on the skull over this area, in association with negative symptoms has previously been shown to distinguish ultra-high risk (UHR) individuals who later transitioned to psychosis (UHR-P) from those who did not transition (UHR-NP).","[{'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Sollychin', 'Affiliation': 'Orygen, the National Centre of Excellence in Youth Mental Health, Parkville, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Bradley N', 'Initials': 'BN', 'LastName': 'Jack', 'Affiliation': 'School of Psychology, UNSW, Sydney, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Polari', 'Affiliation': 'Orygen Youth Health and Melbourne Health, Parkville, Australia.'}, {'ForeName': 'Ayaka', 'Initials': 'A', 'LastName': 'Ando', 'Affiliation': 'Orygen, the National Centre of Excellence in Youth Mental Health, Parkville, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'G Paul', 'Initials': 'GP', 'LastName': 'Amminger', 'Affiliation': 'Orygen, the National Centre of Excellence in Youth Mental Health, Parkville, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Connie', 'Initials': 'C', 'LastName': 'Markulev', 'Affiliation': 'Orygen, the National Centre of Excellence in Youth Mental Health, Parkville, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'McGorry', 'Affiliation': 'Orygen, the National Centre of Excellence in Youth Mental Health, Parkville, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Barnaby', 'Initials': 'B', 'LastName': 'Nelson', 'Affiliation': 'Orygen, the National Centre of Excellence in Youth Mental Health, Parkville, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Whitford', 'Affiliation': 'School of Psychology, UNSW, Sydney, Australia.'}, {'ForeName': 'Hok Pan', 'Initials': 'HP', 'LastName': 'Yuen', 'Affiliation': 'Orygen, the National Centre of Excellence in Youth Mental Health, Parkville, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.'}, {'ForeName': 'Suzie', 'Initials': 'S', 'LastName': 'Lavoie', 'Affiliation': 'Orygen, the National Centre of Excellence in Youth Mental Health, Parkville, Australia; Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia. Electronic address: suzie.lavoie@orygen.org.au.'}]",Schizophrenia research,['10.1016/j.schres.2019.01.039']
2477,30972875,Effect of dual versus mono antiplatelet therapy on recurrent stroke modulated by activated partial thromboplastin time.,"BACKGROUND AND PURPOSE


The efficacy of dual antiplatelet treatment may be modified by many factors. The aim was to assess whether the effect of clopidogrel plus aspirin versus aspirin alone on recurrent stroke would be affected by admission activated partial thromboplastin time (aPTT).
METHODS


Data were derived from the Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events (CHANCE) trial. A total of 5074 patients were categorized into three groups based on the aPTT distribution according to the 15th and 85th percentile. The primary outcome was any stroke within 90 days. The interaction of aPTT with antiplatelet therapy on stroke risk was assessed with a Cox proportional hazards model with adjustment for covariates.
RESULTS


In the high aPTT group (defined as ≥35.9 s), stroke occurred in 6.7% of patients in the clopidogrel-aspirin arm and 11.9% in the aspirin arm [adjusted hazard ratio (HR) 0.50; 95% confidence interval (CI) 0.29-0.85]. In the medium aPTT group (24.6-35.8 s), stroke occurred in 7.7% of patients in the clopidogrel-aspirin arm and 11.8% in the aspirin arm (adjusted HR 0.62; 95% CI 0.50-0.75). Furthermore, in the low aPTT group (≤24.5 s), stroke occurred in 11.2% of patients in the clopidogrel-aspirin arm and 9.9% in the aspirin arm (adjusted HR 1.07; 95% CI 0.65-1.62). The interaction P value of antiplatelet therapy with aPTT level at the cut-point of approximately 25 s or below was significant (P < 0.05).
CONCLUSIONS


Dual antiplatelet therapy was superior to single antiplatelet therapy in the high or medium aPTT group but not in the low aPTT group.",2019,"CONCLUSIONS


Dual antiplatelet therapy was superior to single antiplatelet therapy in the high or medium aPTT group but not in the low aPTT group.","['5074 patients were categorized into three groups based on the aPTT distribution according to the 15th and 85th percentile', 'in High-Risk Patients with Acute Nondisabling Cerebrovascular Events (CHANCE) trial']","['dual versus mono antiplatelet therapy', 'clopidogrel plus aspirin', 'clopidogrel-aspirin', 'aspirin', 'Clopidogrel']","['recurrent stroke modulated by activated partial thromboplastin time', 'admission activated partial thromboplastin time (aPTT', 'stroke risk', 'stroke within 90\xa0days', 'stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",5074.0,0.0483346,"CONCLUSIONS


Dual antiplatelet therapy was superior to single antiplatelet therapy in the high or medium aPTT group but not in the low aPTT group.","[{'ForeName': 'X', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'D T', 'Initials': 'DT', 'LastName': 'Laskowitz', 'Affiliation': 'Department of Neurology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Miao', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Meng', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of neurology,['10.1111/ene.13961']
2478,32812059,"Letter to the editor regarding ""Omega-3 fatty acids reduce post-operative risk of deep vein thrombosis and pulmonary embolism after surgery for elderly patients with proximal femoral fractures: a randomized placebo-controlled, double-blind clinical trial"" by Zheng et al.",,2020,,['elderly patients with proximal femoral fractures'],"['Omega-3 fatty acids', 'placebo']",[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0015802', 'cui_str': 'Fracture of femur'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.398941,,"[{'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Shigemura', 'Affiliation': 'Department of Orthopaedic Surgery, Teikyo University Chiba Medical Center, 3426-3 Anesaki, Ichihara, Chiba, 299-0111, Japan. tshigepon@yahoo.co.jp.'}]",International orthopaedics,['10.1007/s00264-020-04776-7']
2479,32812129,Efficacy and safety of Nd:YAG laser alone compared with combined Nd:YAG laser with intralesional steroid or botulinum toxin A in the treatment of hypertrophic scars.,"The aim of this study is to evaluate the efficacy and safety of Nd:YAG laser alone or in combination with intralesional injection of botulinum toxin type A or intralesional injection of steroid in treatment of hypertrophic scars. This study included 45 patients with hypertrophic scars who were randomly divided into three equal groups. All participants received 4 sessions of Nd:YAG laser at 4-week intervals. Immediately after the laser treatment, patients in group II were assigned to intralesional triamcinolone acetonide, and those in group III were assigned to intralesional botulinum toxin type A. All patients were followed up monthly for 3 months after the last session for any recurrence, or side effects. Clinical evaluation of the cases was done by Vancouver Scar Scale. Hypertrophic scars in the three groups showed a significant improvement (p < 0.001) compared with before treatment in all variables (except for pigmentation) and also a significant improvement in pruritus, pain, and patient relief. The highest percentage of improvements was seen in patients treated with Nd:YAG laser combined with intralesional steroid in all variables according to Vancouver Scar Scale. The degree of improvement was negatively correlated with the patients' age. The three treatment modalities were effective, safe with minimal side effects. Nd:YAG laser followed by intralesional injection of Triamcinolone acetonide had the highest percentage of Vancouver Scar Scale reduction. Combination therapy of Nd:YAG laser with intralesional injection of either Triamcinolone acetonide or Botox revealed better results than using Nd:YAG as a single therapeutic modality for HTS.",2020,"Hypertrophic scars in the three groups showed a significant improvement (p < 0.001) compared with before treatment in all variables (except for pigmentation) and also a significant improvement in pruritus, pain, and patient relief.","['45 patients with hypertrophic scars', 'hypertrophic scars']","['Nd:YAG laser alone', 'botulinum toxin type A or intralesional injection of steroid', 'Triamcinolone acetonide or Botox', 'combined Nd:YAG laser with intralesional steroid or botulinum toxin A', 'intralesional steroid', 'intralesional botulinum toxin type A', 'Triamcinolone acetonide', 'intralesional triamcinolone acetonide']","['pruritus, pain, and patient relief', 'Vancouver Scar Scale reduction', 'Efficacy and safety', 'efficacy and safety', 'Hypertrophic scars']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}]","[{'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021490', 'cui_str': 'Intralesional injection'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0700702', 'cui_str': 'Botox'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}]","[{'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}]",45.0,0.0114424,"Hypertrophic scars in the three groups showed a significant improvement (p < 0.001) compared with before treatment in all variables (except for pigmentation) and also a significant improvement in pruritus, pain, and patient relief.","[{'ForeName': 'Sherine Hosny Abdel', 'Initials': 'SHA', 'LastName': 'Rahman', 'Affiliation': 'Department of Dermatology and Andrology, Faculty of Medicine, Benha Univesity, Banha, Egypt.'}, {'ForeName': 'Manal Saied', 'Initials': 'MS', 'LastName': 'Mohamed', 'Affiliation': 'Department of Dermatology and Andrology, Faculty of Medicine, Benha Univesity, Banha, Egypt.'}, {'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'Hamed', 'Affiliation': 'Department of Dermatology and Andrology, Faculty of Medicine, Benha Univesity, Banha, Egypt. ahmedhamed06@yahoo.com.'}]",Lasers in medical science,['10.1007/s10103-020-03120-0']
2480,32812137,"Simple Wound Irrigation in the Postoperative Treatment for Surgically Drained Spontaneous Soft Tissue Abscesses: A Prospective, Randomized Controlled Trial.","BACKGROUND


Soft tissue abscesses are among the most frequently encountered medical problems treated by different surgeons. Standard therapy remains incision and drainage with sterile saline irrigation during postoperative wound healing period. Aim of this prospective randomized controlled trial was to compare sterile irrigation versus nonsterile irrigation.
STUDY DESIGN


A single center randomized controlled trial was performed to investigate postoperative wound irrigation. The control group used sterile irrigation, and the intervention group used nonsterile irrigation. Primary endpoints were reinfection and reintervention rates, assessed during follow-up controls for up to 2 years. Secondary endpoints were the duration of wound healing, inability to work, pain and quality of life.
RESULTS


Between 04/2016 and 05/2017, 118 patients were randomized into two groups, with 61 allocated to the control- and 57 to the intervention group. Reinfection occurred in a total of 4 cases (6.6%) in the sterile protocol and 4 (7%) in the nonsterile protocol. Quality of life and pain values were comparable during the wound healing period, and patients treated according to the nonsterile irrigation protocol used significantly fewer wound care service teams. Despite equal wound persistence rates, a substantially shorter amount of time off from work was reported in the nonsterile protocol group (p value 0.086).
CONCLUSION


This prospective, randomized trial indicates that a nonsterile irrigation protocol for patients operated on for soft tissue abscesses is not inferior to the standard sterile protocol. Moreover, a nonsterile irrigation protocol leads to a shorter period of inability to work with comparable pain and quality of life scores during the wound healing period.",2020,"Quality of life and pain values were comparable during the wound healing period, and patients treated according to the nonsterile irrigation protocol used significantly fewer wound care service teams.","['patients operated on for soft tissue abscesses is not inferior to the standard sterile protocol', '118 patients', 'Between 04/2016 and 05/2017', 'Surgically Drained Spontaneous Soft Tissue Abscesses']","['sterile irrigation versus nonsterile irrigation', 'sterile irrigation, and the intervention group used nonsterile irrigation', 'sterile saline irrigation', 'nonsterile irrigation protocol', 'Simple Wound Irrigation']","['Reinfection', 'pain and quality of life scores', 'Quality of life and pain values', 'duration of wound healing, inability to work, pain and quality of life', 'reinfection and reintervention rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}]","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0150410', 'cui_str': 'Irrigation of wound'}]","[{'cui': 'C0205339', 'cui_str': 'Reinfection'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C4049481', 'cui_str': 'Inability to work'}]",118.0,0.0682539,"Quality of life and pain values were comparable during the wound healing period, and patients treated according to the nonsterile irrigation protocol used significantly fewer wound care service teams.","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Oehme', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery at the University Hospital Dresden, Carl Gustav Carus University Dresden, P.O. Box 01307, Dresden, Germany. florianoehme85@gmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rühle', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, P.O. Box 69120, Heidelberg, Germany.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Börnert', 'Affiliation': 'Department of Trauma Surgery, Cantonal Hospital Obwalden, Brünigstrasse 181, P.O. Box 6060, 6060, Sarnen, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hempel', 'Affiliation': 'Department for Visceral, Thoracic and Vascular Surgery at the University Hospital Dresden, Carl Gustav Carus University Dresden, P.O. Box 01307, Dresden, Germany.'}, {'ForeName': 'B-C', 'Initials': 'BC', 'LastName': 'Link', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Cantonal Hospital Lucerne, Spitalstrasse 16, P.O. Box 6000, 6000, Lucerne, Switzerland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Babst', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Cantonal Hospital Lucerne, Spitalstrasse 16, P.O. Box 6000, 6000, Lucerne, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Metzger', 'Affiliation': 'Department of General Surgery, Cantonal Hospital Lucerne, Spitalstrasse 16, P.O. Box 6000, 6000, Lucerne, Switzerland.'}, {'ForeName': 'F J-P', 'Initials': 'FJ', 'LastName': 'Beeres', 'Affiliation': 'Department of Orthopaedic and Trauma Surgery, Cantonal Hospital Lucerne, Spitalstrasse 16, P.O. Box 6000, 6000, Lucerne, Switzerland.'}]",World journal of surgery,['10.1007/s00268-020-05738-1']
2481,32812177,Reduction of breast lymphoedema secondary to breast cancer: a randomised controlled exercise trial.,"BACKGROUND


Breast lymphoedema can occur following surgical treatment for breast cancer. We investigated whether an exercise program reduced breast lymphoedema symptoms compared to a non-exercise control group.
METHODS


A single-blinded randomised controlled trial was conducted in which women with stable breast lymphoedema (n = 89) were randomised into an exercise (n = 41) or control (n = 47) group. The intervention comprised a 12-week combined aerobic and resistance training program, supervised weekly by an accredited exercise physiologist. All participants completed a weekly symptoms diary and were assessed monthly to ensure that there was no exacerbation of their lymphoedema. Changes in the breast were captured physically with ultrasound and bioimpedance spectroscopy and changes in symptoms were captured using European Organization for Research and Treatment of Cancer (EORTC) Breast Cancer (BR23) and Lymphoedema Symptom Intensity and Distress questionnaires.
RESULTS


The exercise group reported a greater reduction in breast-related symptoms than the control group, assessed by the EORTC BR23 breast symptom questions. Measures of extracellular fluid, assessed with bioimpedance spectroscopy ratio, decreased in the exercise group compared to the control group. No significant difference was detected in dermal thickness in the breast, assessed by ultrasound. Session attendance in the exercise sessions was high, with two musculoskeletal adverse events reported, but no exacerbations of lymphoedema observed.
CONCLUSION


Combined resistance and aerobic exercise training is safe for women living with breast lymphoedema. Preliminary data suggest exercise training can reduce breast lymphoedema symptoms to a greater extent than usual care.",2020,"The exercise group reported a greater reduction in breast-related symptoms than the control group, assessed by the EORTC BR23 breast symptom questions.","['breast cancer', 'breast lymphoedema secondary to breast cancer', 'women living with breast lymphoedema', 'women with stable breast lymphoedema (n\u2009=\u200989']","['exercise training', 'Combined resistance and aerobic exercise training', 'exercise program', 'combined aerobic and resistance training program, supervised weekly by an accredited exercise physiologist', 'exercise (n\u2009=\u200941) or control']","['breast lymphoedema symptoms', 'Session attendance', 'dermal thickness', 'bioimpedance spectroscopy ratio', 'Breast Cancer (BR23) and Lymphoedema Symptom Intensity and Distress questionnaires', 'breast-related symptoms', 'Cancer (EORTC']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0260141', 'cui_str': 'Physiologist'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",89.0,0.0640697,"The exercise group reported a greater reduction in breast-related symptoms than the control group, assessed by the EORTC BR23 breast symptom questions.","[{'ForeName': 'S L', 'Initials': 'SL', 'LastName': 'Kilbreath', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney, Sydney, Australia. sharon.kilbreath@sydney.edu.au.'}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Ward', 'Affiliation': 'School of Chemistry and Molecular Biosciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Davis', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Degnim', 'Affiliation': 'Department of Surgery, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Hackett', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Skinner', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Black', 'Affiliation': 'Sydney School of Health Sciences, Faculty of Medicine & Health, The University of Sydney, Sydney, Australia.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05863-4']
2482,32812191,Social Interaction Skill Intervention for Autistic Adults with Intellectual Disability and Limited Language: A Pilot of the SKILL Program.,"There is a dearth of research that focuses on social intervention efforts for adults on the autism spectrum with intellectual disability and limited conversational language. Using a multiple baseline experimental design, this pilot investigation of the Socialization Knowledge for Individuals with Limited Language (SKILL) program evaluated a novel peer-facilitated group program specifically designed to target social interaction skills for this population. Findings from five pilot participants yielded evidence of social improvements across specific verbal skills (on-topic conversational contributions and responses) and nonverbal behaviors (eye-contact, active listening), as evidenced by coded social conversation probes and parent-report measures. These findings demonstrate the promise of a socialization intervention for a population that has historically been neglected in the social intervention research literature.",2020,"Findings from five pilot participants yielded evidence of social improvements across specific verbal skills (on-topic conversational contributions and responses) and nonverbal behaviors (eye-contact, active listening), as evidenced by coded social conversation probes and parent-report measures.","['Autistic Adults with Intellectual Disability and Limited Language', 'Individuals with Limited Language (SKILL) program', 'adults on the autism spectrum with intellectual disability and limited conversational language']","['Social Interaction Skill Intervention', 'socialization intervention']","['social improvements across specific verbal skills (on-topic\xa0conversational contributions and responses) and nonverbal behaviors (eye-contact, active listening']","[{'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037447', 'cui_str': 'Socialization'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0518605', 'cui_str': 'Social interaction skills'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037447', 'cui_str': 'Socialization'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0150122', 'cui_str': 'Active listening'}]",5.0,0.0223724,"Findings from five pilot participants yielded evidence of social improvements across specific verbal skills (on-topic conversational contributions and responses) and nonverbal behaviors (eye-contact, active listening), as evidenced by coded social conversation probes and parent-report measures.","[{'ForeName': 'Emily F', 'Initials': 'EF', 'LastName': 'Ferguson', 'Affiliation': 'Koegel Autism Center, University of California Santa Barbara, Santa Barbara, CA, USA. fergusonef1@gmail.com.'}, {'ForeName': 'Krista N', 'Initials': 'KN', 'LastName': 'Drapalik', 'Affiliation': 'Koegel Autism Center, University of California Santa Barbara, Santa Barbara, CA, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'Koegel Autism Center, University of California Santa Barbara, Santa Barbara, CA, USA.'}, {'ForeName': 'Klaire', 'Initials': 'K', 'LastName': 'Hua', 'Affiliation': 'Koegel Autism Center, University of California Santa Barbara, Santa Barbara, CA, USA.'}, {'ForeName': 'Harrison', 'Initials': 'H', 'LastName': 'Feerst', 'Affiliation': 'Koegel Autism Center, University of California Santa Barbara, Santa Barbara, CA, USA.'}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Mallory', 'Affiliation': 'Koegel Autism Center, University of California Santa Barbara, Santa Barbara, CA, USA.'}, {'ForeName': 'Ty W', 'Initials': 'TW', 'LastName': 'Vernon', 'Affiliation': 'Koegel Autism Center, University of California Santa Barbara, Santa Barbara, CA, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-020-04659-1']
2483,32812388,"Intraoperative ketamine for reduction in postpartum depressive symptoms after cesarean delivery: A double-blind, randomized clinical trial.","BACKGROUND


Postpartum depression (PPD) is a common mental disease happens in perinatal period. Ketamine as an anesthesia and analgesia drug has been used for a long time. In recent years, ketamine is proved to have an antidepression effect with a single administration. We hypothesized that intraoperative ketamine can reduce postpartum depressive symptoms after cesarean delivery.
METHODS


In a randomized, double-blind, placebo-controlled study trail, healthy women scheduled for cesarean delivery were randomly assigned to receive intravenous ketamine (0.25 mg/kg diluted to 5 ml with 0.9% saline) or placebo (5 ml of 0.9% saline) within 5 min following clamping of the neonatal umbilical cord. The primary outcome was the degree of postpartum depressive symptoms, which was evaluated by Edinburgh Postnatal Depression Scale (EPDS, a threshold of 9/10 was used) at 1 week, 2 weeks, and 1 month after delivery. The secondary outcome was the numerical rating scale (NRS) score of pain at 2 days postpartum. This trail is registered in the Chinese Clinical Trial Registry, number ChiCTR1900022464.
RESULTS


Between 26 January 2019 and 15 July 2019, 502 subjects were screened and 330 were randomly allocated: 165 (50%) to the ketamine group and 165 (50%) to the placebo group. There were significant differences in the degree of postpartum depressive symptoms between subjects in the ketamine group and the placebo group at 1 week postpartum (13.1% vs. 22.6%, respectively; p = .029). However, no difference was found between subjects in the two groups at 2 weeks (11.8% vs. 16.8%, respectively; p = .209) and 1 month postpartum (10.5% vs. 14.2%, respectively; p = .319). The NRS score of wound pain (3.0 ± 0.9 vs. 4.0 ± 1.0, respectively; p < .001) and uterine contraction pain (3.0 ± 0.9 vs. 4.1 ± 0.9, respectively; p < .001) was lower in the ketamine group at 2 days postpartum compared with placebo group. The prevalence of headache, hallucination, and dizziness was higher in the ketamine group than the placebo group during the operation.
CONCLUSIONS


Operative intravenous ketamine (0.25 mg/kg) can reduce the postpartum depressive symptoms for 1 week. The long-time effect is remained to be seen.",2020,"There were significant differences in the degree of postpartum depressive symptoms between subjects in the ketamine group and the placebo group at 1 week postpartum (13.1% vs. 22.6%, respectively; p = .029).","['Between 26 January 2019 and 15 July 2019, 502 subjects were screened and 330 were randomly allocated: 165 (50%) to the', 'healthy women scheduled for cesarean delivery', 'postpartum depressive symptoms after cesarean delivery']","['intravenous ketamine (0.25\xa0mg/kg diluted to 5\xa0ml with 0.9% saline) or placebo', 'ketamine', 'Ketamine', 'Intraoperative ketamine', 'intraoperative ketamine', 'placebo']","['numerical rating scale (NRS) score of pain', 'degree of postpartum depressive symptoms, which was evaluated by Edinburgh Postnatal Depression Scale (EPDS', 'postpartum depressive symptoms', 'prevalence of headache, hallucination, and dizziness', 'uterine contraction pain', 'NRS score of wound pain', 'degree of postpartum depressive symptoms']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0042130', 'cui_str': 'Uterine contraction'}, {'cui': 'C0241745', 'cui_str': 'Wound pain'}]",502.0,0.754281,"There were significant differences in the degree of postpartum depressive symptoms between subjects in the ketamine group and the placebo group at 1 week postpartum (13.1% vs. 22.6%, respectively; p = .029).","[{'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'The Second Department of Anesthesia, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Song', 'Affiliation': 'The Second Department of Anesthesia, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Second Department of Anesthesia, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Guo', 'Affiliation': 'The Second Department of Anesthesia, Shengjing Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'The Second Department of Anesthesia, Shengjing Hospital of China Medical University, Shenyang, China.'}]",Brain and behavior,['10.1002/brb3.1715']
2484,32812403,Mildly Elevated Cardiac Troponin below the 99th-Percentile Upper Reference Limit after Noncardiac Surgery.,"BACKGROUND AND OBJECTIVES


In patients with perioperative cardiac troponin (cTn) I below the 99th-percentile upper range of limit (URL), mortality according to cTn I level has not been fully evaluated. This study evaluated the association between postoperative cTn I level above the lowest limit of detection but within the 99th-percentile URL and 30-day mortality after noncardiac surgery.
METHODS


Patients with cTn I values below the 99th-percentile URL during the perioperative period were divided into a no-elevation group with cTn I at the lowest limit of detection (6 ng/L) and a minor elevation group with cTn I elevation below the 99th percentile URL (6 ng/L < cTn I < 40 ng/L). The primary outcome was 30-day mortality.
RESULTS


Of the 5,312 study participants, 2,582 (48.6%) were included in the no-elevation group and 2,730 (51.4%) were included in the minor elevation group. After propensity score-matching, the minor elevation group showed significantly increased 30-day mortality (0.5% vs. 2.3%; hazard ratio, 4.30; 95% confidence interval, 2.23-8.29; p<0.001). The estimated cutoff value of cTn I to predict 30-day mortality was 6 ng/L with the area under the receiver operating characteristic curve 0.657.
CONCLUSIONS


A mild elevation of cTn I within the 99th-percentile URL after noncardiac surgery was significantly associated with increased 30-day mortality as compared with the lowest limit of detection.
TRIAL REGISTRATION


Clinical Research Information Service Identifier: KCT0004244.",2020,"After propensity score-matching, the minor elevation group showed significantly increased 30-day mortality (0.5% vs. 2.3%; hazard ratio, 4.30; 95% confidence interval, 2.23-8.29; p<0.001).","['patients with perioperative cardiac troponin (cTn', 'Of the 5,312 study participants, 2,582 (48.6%) were included in the no-elevation group and 2,730 (51.4%) were included in the minor elevation group', 'Patients with cTn I values below the 99th-percentile URL during the perioperative period']",['no-elevation group with cTn'],"['30-day mortality', 'mild elevation of cTn', 'Mildly Elevated Cardiac Troponin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}]","[{'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0205250', 'cui_str': 'High'}]",5312.0,0.16335,"After propensity score-matching, the minor elevation group showed significantly increased 30-day mortality (0.5% vs. 2.3%; hazard ratio, 4.30; 95% confidence interval, 2.23-8.29; p<0.001).","[{'ForeName': 'Jungchan', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Cheol Won', 'Initials': 'CW', 'LastName': 'Hyeon', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Seung Hwa', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. shuaaa.lee@samsung.com.'}, {'ForeName': 'Jihoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Ji Hye', 'Initials': 'JH', 'LastName': 'Kwon', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Kwangmo', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Center for Health Promotion, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeong Jin', 'Initials': 'JJ', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jong Hwan', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Sangmin Maria', 'Initials': 'SM', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jeong Hoon', 'Initials': 'JH', 'LastName': 'Yang', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Young Bin', 'Initials': 'YB', 'LastName': 'Song', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Joo Yong', 'Initials': 'JY', 'LastName': 'Hahn', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Ho', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Seung Hyuk', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyunga', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Joonghyun', 'Initials': 'J', 'LastName': 'Ahn', 'Affiliation': 'Statistics and Data Center, Research Institute for Future Medicine, Samsung Medical Center, Seoul, Korea.'}, {'ForeName': 'Hyeon Cheol', 'Initials': 'HC', 'LastName': 'Gwon', 'Affiliation': 'Division of Cardiology, Department of Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",Korean circulation journal,['10.4070/kcj.2020.0088']
2485,32812478,The effectiveness of pain neuroscience education combined with manual therapy and home exercise for chronic low back pain: A single-blind randomized controlled trial.,"OBJECTIVES


The aim of this study was to investigate the short- and mid-term effects of pain neuroscience education (PNE) combined with manual therapy (MT) and a home exercise program (HEP) on pain intensity, back performance, disability, and kinesiophobia in patients with chronic low back pain (CLBP).  Methods : This study was designed as a prospective, randomized, controlled, single-blind study in which 69 participants were randomly assigned to three groups. Participants in Group 1 received PNE, MT, and the HEP, while Group 2 received MT and the HEP. Participants in the control group did the HEP only. All interventions lasted 4 weeks. The participants' pain intensity, disability, low back performance, and kinesiophobia were assessed. All assessments were executed before intervention, at 4 weeks, and at 12 weeks post-intervention by the same blinded physiotherapist. A mixed model for repeated measures was used for each outcome measure.  Results : Analysis of pain level ( p  < .05), back performance ( p  < .05), disability ( p  < .05) and kinesiophobia ( p  < .05) revealed significant time, group, and time-by-group interaction effects. The participants in Group 1 exhibited greater improvement in terms of pain intensity and kinesiophobia compared to the participants in Group 2 and the control group. Level of disability was significantly decreased in both Group 1 and Group 2 compared to the control group.  Conclusion : This study suggests that a multimodal treatment program combining PNE, MT, and HEP is an effective method for improving back performance and reducing pain, disability, and kinesiophobia in the short (4 weeks) and midterm (12 weeks).",2020,"Analysis of pain level ( p  < .05), back performance ( p  < .05), disability ( p  < .05) and kinesiophobia ( p  < .05) revealed significant time, group, and time-by-group interaction effects.","['chronic low back pain', 'patients with chronic low back pain (CLBP', '69 participants']","['pain neuroscience education combined with manual therapy and home exercise', 'PNE, MT, and the HEP, while Group 2 received MT and the HEP', 'pain neuroscience education (PNE) combined with manual therapy (MT) and a home exercise program (HEP']","['pain level', 'disability', 'pain intensity, back performance, disability, and kinesiophobia', 'back performance', 'pain intensity, disability, low back performance, and kinesiophobia', 'Level of disability', 'back performance and reducing pain, disability, and kinesiophobia', 'pain intensity and kinesiophobia', 'kinesiophobia']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3489398', 'cui_str': 'Peripheral neuroepithelioma'}, {'cui': 'C0162569', 'cui_str': 'Homozygous porphyria cutanea tarda'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",69.0,0.0860582,"Analysis of pain level ( p  < .05), back performance ( p  < .05), disability ( p  < .05) and kinesiophobia ( p  < .05) revealed significant time, group, and time-by-group interaction effects.","[{'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Saracoglu', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Kutahya Health Sciences University , Kutahya, Turkey.'}, {'ForeName': 'Meltem Isintas', 'Initials': 'MI', 'LastName': 'Arik', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Kutahya Health Sciences University , Kutahya, Turkey.'}, {'ForeName': 'Emrah', 'Initials': 'E', 'LastName': 'Afsar', 'Affiliation': 'Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Kutahya Health Sciences University , Kutahya, Turkey.'}, {'ForeName': 'Hasan Huseyin', 'Initials': 'HH', 'LastName': 'Gokpinar', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Kutahya Health Sciences University , Kutahya, Turkey.'}]",Physiotherapy theory and practice,['10.1080/09593985.2020.1809046']
2486,32812489,Antenatal-Based Pilot Psychosocial Intervention to Enhance Mental Health of Pregnant Women Experiencing Domestic and Family Violence in Nepal.,"Survivors of domestic and family violence (DFV) report poorer quality of life and worsening mental health. This study evaluated the effect of a counseling and education intervention on the mental health and help-seeking behaviors among pregnant women living with DFV. A parallel pilot randomized controlled trial was performed among 140 pregnant women attending an antenatal clinic of a tertiary hospital of Nepal. Using computer-generated random numbers, participants were randomized to the intervention group (a counseling session, an information booklet about DFV, and contact details of the counselor) or a control group (usual care plus a booklet containing contact details of local DFV support services). Outcome measures included mental health, quality of life (QOL), self-efficacy, social support, and safety planning behaviors. Analyses followed intention-to-treat, using the generalized estimating equation model. Intervention participants showed significant improvements in anxiety (β = -3.24,  p  < .001) and depression (β = -3.16,  p  < .001) at postintervention. Such improvements were also sustained at follow-up assessment ( p  < .001). Significant group and time interaction for QOL, social support, use of safety behaviors, and self-efficacy ( p  < .05) revealed a greater increase in these outcome measures among intervention participants at both follow-up assessments compared with the control group. This pilot integrated intervention showed promising outcomes in improving the mental health, social support, and the use of safety behaviors among women with DFV. This intervention could be incorporated into regular antenatal care as a strategy to identify and support victims of DFV. Larger controlled trials with longer follow-up are needed to support and expand on the current findings regarding the effectiveness of a psychosocial intervention targeting victims of DFV in resource-constrained settings.",2020,Intervention participants showed significant improvements in anxiety (,"['Pregnant Women Experiencing Domestic and Family Violence in Nepal', 'pregnant women living with DFV', '140 pregnant women attending an antenatal clinic of a tertiary hospital of Nepal', 'Survivors of domestic and family violence (DFV', 'women with DFV']","['counseling and education intervention', 'Antenatal-Based Pilot Psychosocial Intervention', 'intervention group (a counseling session, an information booklet about DFV, and contact details of the counselor) or a control group (usual care plus a booklet containing contact details of local DFV support services']","['anxiety ', 'quality of life and worsening mental health', 'time interaction for QOL, social support, use of safety behaviors, and self-efficacy', 'mental health, quality of life (QOL), self-efficacy, social support, and safety planning behaviors', 'depression']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003063', 'cui_str': 'Domestic Animals'}, {'cui': 'C0206072', 'cui_str': 'Family Violence'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0003063', 'cui_str': 'Domestic Animals'}, {'cui': 'C0206072', 'cui_str': 'Family Violence'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C1321226', 'cui_str': 'Safety behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",140.0,0.0556739,Intervention participants showed significant improvements in anxiety (,"[{'ForeName': 'Diksha', 'Initials': 'D', 'LastName': 'Sapkota', 'Affiliation': 'Griffith University, Meadowbrook, Queensland, Australia.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Baird', 'Affiliation': 'Griffith University, Meadowbrook, Queensland, Australia.'}, {'ForeName': 'Amornrat', 'Initials': 'A', 'LastName': 'Saito', 'Affiliation': 'Griffith University, Meadowbrook, Queensland, Australia.'}, {'ForeName': 'Pappu', 'Initials': 'P', 'LastName': 'Rijal', 'Affiliation': 'B.P. Koirala Institute of Health Sciences, Dharan, Nepal.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Anderson', 'Affiliation': 'Menzies Health Institute Queensland, Gold Coast, Australia.'}]",Journal of interpersonal violence,['10.1177/0886260520948151']
2487,32812667,Automated exchange compared to manual and simple blood transfusion attenuates rise in ferritin level after 1 year of regular blood transfusion therapy in chronically transfused children with sickle cell disease.,"BACKGROUND


Optimal strategies for regular blood transfusion therapy are not well defined in sickle cell disease (SCD). This analysis tested the hypothesis that in the first of year of regular transfusions, when chelation therapy use is minimal, automated exchange transfusion would be the superior method for attenuating the rise in ferritin levels compared to simple and manual exchange transfusions.
STUDY DESIGN AND METHODS


The Silent Cerebral Infarct Multi-Center Clinical Trial randomly allocated children with SCD and silent cerebral infarcts to receive standard care or regular transfusions with a target pre-transfusion HbS concentration ≤ 30% and minimum hemoglobin level > 9.0 g/dL. Participants with at least nine transfusions and sufficient ferritin testing in the first year of the trial were included in a planned secondary analysis. Ferritin levels by the end of the first study year were compared between participants receiving automatic exchange transfusion, manual exchange transfusion, and simple transfusion.
RESULTS


A total of 83 participants were analyzed. During the first year of the study, 75.9% of the participants had >80% of transfusions via one transfusion method. At baseline no significant differences in ferritin levels were observed in the three transfusion groups (p = 0.1). After 1 year of transfusions the median (interquartile range) ferritin levels in the simple transfusion (n = 40), manual exchange transfusion (n = 34) and automatic exchange transfusion (n = 9) groups were 1800 ng/mL (1426-2204 ng/mL), 1530 ng/mL (1205-1805 ng/mL), and 355 ng/mL (179-579 ng/mL), respectively (p < 0.001).
CONCLUSION


Automated exchange transfusion, when compared to other transfusion methods, is the optimal transfusion strategy for attenuating increase in ferritin levels in children with SCD.",2020,"Automated exchange transfusion, when compared to other transfusion methods, is the optimal transfusion strategy for attenuating increase in ferritin levels in children with SCD.","['A total of 83 participants were analyzed', 'chronically transfused children with sickle cell disease', 'children with SCD']","['standard care or regular transfusions with a target pre-transfusion HbS concentration\u2009≤\u200930% and minimum hemoglobin level\u2009>\u20099.0 g/dL. Participants with at least nine transfusions and sufficient ferritin testing', 'Automated exchange compared to manual and simple blood transfusion']","['Ferritin levels', 'ferritin levels', 'ferritin level']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0205352', 'cui_str': 'Simple'}]","[{'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}]",83.0,0.190826,"Automated exchange transfusion, when compared to other transfusion methods, is the optimal transfusion strategy for attenuating increase in ferritin levels in children with SCD.","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Kelly', 'Affiliation': 'Department of Epidemiology, Vitalant Research Institute, San Francisco, California, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Rodeghier', 'Affiliation': 'Rodeghier Consultants, Chicago, Illinois, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'DeBaun', 'Affiliation': 'Department of Pediatrics, Division of Hematology/Oncology, Vanderbilt-Meharry Center for Excellence in Sickle Cell Disease, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}]",Transfusion,['10.1111/trf.15982']
2488,32812783,"Commentary on ""Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): a prospective, randomised, multi-centre study"".",,2020,,['patients with high-risk prostate cancer before curative-intent surgery or'],"['Prostate-specific membrane antigen PET-CT', 'radiotherapy (proPSMA']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0067685', 'cui_str': 'Glutamate carboxypeptidase II'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.0381778,,"[{'ForeName': 'Sungmin', 'Initials': 'S', 'LastName': 'Woo', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.'}, {'ForeName': 'Hebert Alberto', 'Initials': 'HA', 'LastName': 'Vargas', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA.'}]",AJR. American journal of roentgenology,['10.2214/AJR.20.23666']
2489,32812824,"Excess Body Weight and Cancer-Related Fatigue, Systemic Inflammation, and Serum Lipids in Breast Cancer Survivors.","BACKGROUND


Cancer-related fatigue (CRF) is a common side effect impacting breast cancer survivors. Research points to a relationship between obesity and CRF in breast cancer survivors related to elevated systemic inflammation and metabolic alterations.
METHODS


This cross-sectional study examined the relationship of obesity to CRF, inflammatory markers and serum lipids through a secondary analysis of a nationwide randomized controlled trial. Breast cancer survivors with CRF were categorized based on BMI category. Symptoms of CRF, inflammatory markers and serum fatty acids were assessed among groups.
RESULTS


There were 105 breast cancer survivors in the analysis. BMI was positively associated with CRF based on MFSI General ( p  = 0.020; 95% C.I. 0.024, 0.273) and MFSI Physical ( p  = 0.013; 95% C.I. 0.035, 0.298) subscales. TNF-α ( p  = 0.007; 95% C.I. 0.007, 0.044), and IL-6 ( p  = 0.020; 95% C.I. 0.006, 0.073) were elevated in the obese. Monounsaturated fatty acid levels ( p  = 0.047; 95% C.I. 0.000, 0.053) and the omega-6 to omega-3 fatty acid ratio were associated with obesity ( p  = 0.047; 95% C.I. 0.002, 0.322).
CONCLUSIONS


Obese breast cancer survivors had greater levels of CRF, inflammatory markers and certain fatty acids. Inflammatory markers and fatty acids were not found to have any mediating or positive association with CRF variables in this analysis. NCT02352779.",2020,"Monounsaturated fatty acid levels ( p  = 0.047; 95% C.I. 0.000, 0.053) and the omega-6 to omega-3 fatty acid ratio were associated with obesity ( p  = 0.047; 95% C.I. 0.002, 0.322).
","['Breast Cancer Survivors', 'breast cancer survivors', 'Obese breast cancer survivors', 'Breast cancer survivors with CRF', '105 breast cancer survivors']",['TNF-α'],"['omega-6 to omega-3 fatty acid ratio', 'CRF, inflammatory markers and certain fatty acids', 'Symptoms of CRF, inflammatory markers and serum fatty acids', 'BMI', 'MFSI Physical', 'Monounsaturated fatty acid levels', 'IL-6', 'Excess Body Weight and Cancer-Related Fatigue, Systemic Inflammation, and Serum Lipids']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]","[{'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1281901', 'cui_str': 'Fatty acid measurement'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}]",105.0,0.0862551,"Monounsaturated fatty acid levels ( p  = 0.047; 95% C.I. 0.000, 0.053) and the omega-6 to omega-3 fatty acid ratio were associated with obesity ( p  = 0.047; 95% C.I. 0.002, 0.322).
","[{'ForeName': 'Julia E', 'Initials': 'JE', 'LastName': 'Inglis', 'Affiliation': 'Department of Public and Community Health, Liberty University, Lynchburg, VA, USA.'}, {'ForeName': 'Amber S', 'Initials': 'AS', 'LastName': 'Kleckner', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center (URMC), Rochester, NY, USA.'}, {'ForeName': 'Po-Ju', 'Initials': 'PJ', 'LastName': 'Lin', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center (URMC), Rochester, NY, USA.'}, {'ForeName': 'Nikesha J', 'Initials': 'NJ', 'LastName': 'Gilmore', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center (URMC), Rochester, NY, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center (URMC), Rochester, NY, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'VanderWoude', 'Affiliation': 'Cancer Research Consortium of West Michigan, Grand Rapids, MI, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Mustian', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center (URMC), Rochester, NY, USA.'}, {'ForeName': 'I Diana', 'Initials': 'ID', 'LastName': 'Fernandez', 'Affiliation': 'Department of Public Health Sciences, University of Rochester Medical Center (URMC), Rochester, NY, USA.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Dunne', 'Affiliation': 'Department of Medicine, University of Rochester Medical Center (URMC), Rochester, NY, USA.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Deutsch', 'Affiliation': 'Cancer Center of Kansas, Wichita, KS, USA.'}, {'ForeName': 'Luke J', 'Initials': 'LJ', 'LastName': 'Peppone', 'Affiliation': 'Department of Surgery, University of Rochester Medical Center (URMC), Rochester, NY, USA.'}]",Nutrition and cancer,['10.1080/01635581.2020.1807574']
2490,32812836,Patient characteristics associated with improvements in asthma control and reduction in emergency department visits for older adults with asthma.,"OBJECTIVE


To identify patient characteristics associated with improvements in asthma control among older adults with asthma.
METHODS


Secondary analysis of data from a randomized controlled trial of an asthma self-management support intervention for adults ages 60 and older with moderate-severe persistent asthma ( n  = 391). We tested the association of baseline patient characteristics with reduced emergency department (ED) visits and improvement in asthma control equal to or exceeding the minimal clinically important difference (MCID) in asthma control test (ACT) scores (3.0) 12 months.
RESULTS


At baseline, the mean age was 68 years, 15.0% were male, 30.3% were black, and 56.5% were Hispanic. Patients with a history of ED visits in the 12 months preceding study enrollment were significantly more likely to experience an ED visit during the study period (adjusted odds ratio [AOR] 6.92, 95% confidence interval [CI] 2.18-21.9,  p  < .0001). Similarly, those with poorer asthma control (baseline ACT scores <13) had greater odds of achieving improved asthma control (AOR 13.7, 95% CI 5.32-35.1,  p  < .0001). No other variables had statistically significant associations with the outcomes.
CONCLUSIONS


Low scores on the asthma control test and prior ED visits for asthma are strong correlates of later clinically meaningful changes in asthma control among older adults. Health systems preparing for population management of patients with asthma ought to consider incorporating serial collection of data on the ACT into the monitoring and management of older asthmatics, a high-risk patient population.",2020,"Patients with a history of ED visits in the 12 months preceding study enrollment were significantly more likely to experience an ED visit during the study period (adjusted odds ratio [AOR] 6.92, 95% confidence interval [CI] 2.18-21.9,  p  < .0001).","['adults ages 60 and older with moderate-severe persistent asthma ( n \u2009=\u2009391', 'patients with asthma', 'older adults', 'mean age was 68\u2009years, 15.0% were male, 30.3% were black, and 56.5% were Hispanic', 'older adults with asthma']",['asthma self-management support intervention'],"['asthma control', 'asthma control test (ACT) scores', 'emergency department visits']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1960048', 'cui_str': 'Severe persistent asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}]","[{'cui': 'C1319219', 'cui_str': 'Asthma self-management behavior'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]",,0.0352231,"Patients with a history of ED visits in the 12 months preceding study enrollment were significantly more likely to experience an ED visit during the study period (adjusted odds ratio [AOR] 6.92, 95% confidence interval [CI] 2.18-21.9,  p  < .0001).","[{'ForeName': 'Alex D', 'Initials': 'AD', 'LastName': 'Federman', 'Affiliation': 'Division of General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Thanik', 'Affiliation': 'Department of Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': ""O'Conor"", 'Affiliation': 'Division of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Arushi', 'Initials': 'A', 'LastName': 'Arora', 'Affiliation': 'Division of General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Wolf', 'Affiliation': 'Division of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Wisnivesky', 'Affiliation': 'Division of General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1805753']
2491,32812837,Inspiratory muscle training at sea level improves the strength of inspiratory muscles during load carriage in cold-hypoxia.,"Inspiratory muscle training (IMT) and functional IMT (IMT F : exercise-specific IMT activities) has been unsuccessful in reducing respiratory muscle fatigue following load carriage. IMT F  did not include load carriage specific exercises. Fifteen participants split into two groups (training and control) walked 6   km loaded (18.2   kg) at speeds representing ∼50%V̇O 2max  in cold-hypoxia. The walk was completed at baseline; post 4   weeks IMT and 4   weeks IMT F  (five exercises engaging core muscles, three involved load). The training group completed IMT and IMT F  at a higher maximal inspiratory pressure (P imax ) than controls. Improvements in P imax  were greater in the training group post-IMT (20.4%,  p     =   .025) and post-IMT F  (29.1%,  p     =   .050) compared to controls. Respiratory muscle fatigue was unchanged ( p     =   .643). No other physiological or subjective measures were improved by IMT or IMT F . Both IMT and IMT F  increased the strength of respiratory muscles pre-and-post a 6   km loaded walk in cold-hypoxia.  Practitioner Summary:  To explore the interaction between inspiratory muscle training (IMT), load carriage and environment, this study investigated 4   weeks IMT and 4   weeks functional IMT on respiratory muscle strength and fatigue. Functional IMT improved inspiratory muscle strength pre-and-post a loaded walk in cold-hypoxia but had no more effect than IMT alone.  Abbreviations:  ANOVA: analysis of variance; BF: breathing frequency; CON: control group; EELV: end-expiratory lung volume; EXP: experimental group; FEV 1 : forced expiratory volume in one second; FiO 2 : fraction of inspired oxygen; FVC: forced vital capacity; HR: heart rate; IMT: inspiratory muscle training; IMT F : functional inspiratory muscle training; P emax : maximal expiratory pressure; P imax : maximal inspiratory pressure; RMF: respiratory muscle fatigue; RPE: rate of perceived exertion; RWU: respiratory muscle warm-up; SaO 2 : arterial oxygen saturation; SpO 2 : peripheral oxygen saturation; V̇E: minute ventilation; V̇O 2 : rate of oxygen uptake.",2020,Both IMT and IMT F  increased the strength of respiratory muscles pre-and-post a 6   km loaded walk in cold-hypoxia.  ,[],"['Inspiratory muscle training (IMT) and functional IMT (IMT F : exercise-specific IMT activities', 'IMT and 4 \u2009 weeks functional IMT', 'inspiratory muscle training (IMT', 'IMT and IMT F  at a higher maximal inspiratory pressure', 'Inspiratory muscle training at sea level', 'IMT']","['Respiratory muscle fatigue', 'physiological or subjective measures', 'P imax', 'respiratory muscle strength and fatigue']",[],"[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0036493', 'cui_str': 'Sea'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0021724', 'cui_str': 'Structure of intercostal muscle'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",15.0,0.0219574,Both IMT and IMT F  increased the strength of respiratory muscles pre-and-post a 6   km loaded walk in cold-hypoxia.  ,"[{'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Hinde', 'Affiliation': 'Defence Science and Technology Laboratory, Salisbury, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Low', 'Affiliation': 'Carnegie School of Sport, Leeds Beckett University, Leeds, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Lloyd', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, UK.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Cooke', 'Affiliation': 'School of Social and Health Sciences, Leeds Trinity University, Leeds, UK.'}]",Ergonomics,['10.1080/00140139.2020.1807613']
2492,32812844,A Yoga-Based Program Decreases Physician Burnout in Neonatologists and Obstetricians at an Academic Medical Center.,"BACKGROUND


Nearly half of U.S. pediatricians have symptoms of burnout. This pilot study examined the feasibility of a 6-week yoga-based program (RISE) for neonatologists and obstetricians at Brigham and Women's Hospital and studied the effects on burnout, professional fulfillment, and psychological health.
METHODS


Participants were recruited via email to participate either in both program and research study, or exclusively the program. RISE was delivered 1 hour/week during the workday for 6 consecutive weeks either in-person or remotely; 18 physicians participated, 12 completed post-program, and 11 completed 2-month follow-up. The questionnaires assessed burnout and measures of psychological health, professional fulfillment, work exhaustion, interpersonal disengagement/burnout (PFI), mindfulness (FFMQ), perceived stress (PSS), positive/negative affect (PANAS), resilience (RS), anxiety/depression/sleep disturbances (PROMIS), at baseline, post-program, and 2 months after RISE.
FINDINGS


Average attendance in-person was 2.8 sessions and remotely 1.4 sessions (4.2/6 sessions). Participants demonstrating total burnout reduced from 50.0% at baseline to 9.1% post-program. Participants demonstrating professional fulfillment were 8.3% at baseline and 27.3% post-program. Paired samples  t -tests revealed statistically significant improvements in burnout, professional fulfillment, interpersonal disengagement, stress, resilience, anxiety, and depression at post-program compared with baseline ( N  = 12, all  p s < .05). At 2-month follow-up, statistically significant improvements in interpersonal disengagement, resilience, and mindfulness ( N  = 11, all  p s < .05) compared with baseline were reported.
CONCLUSIONS/APPLICATION TO PRACTICE


RISE is feasible within a workday and may address burnout and other psychological health measures in physicians with effects potentially sustainable over 2 months. Occupational health practitioners in health care should consider this type of intervention for their workers.",2020,"t -tests revealed statistically significant improvements in burnout, professional fulfillment, interpersonal disengagement, stress, resilience, anxiety, and depression at post-program compared with baseline ( N  = 12,","['Occupational health practitioners in health care', 'in Neonatologists and Obstetricians at an Academic Medical Center', 'Participants were recruited via email to participate either in both program and research study, or exclusively the program']","['6-week yoga-based program (RISE', 'Yoga-Based Program Decreases Physician Burnout']","['questionnaires assessed burnout and measures of psychological health, professional fulfillment, work exhaustion, interpersonal disengagement/burnout (PFI), mindfulness (FFMQ), perceived stress (PSS), positive/negative affect (PANAS), resilience (RS), anxiety/depression/sleep disturbances (PROMIS', 'professional fulfillment', 'burnout, professional fulfillment, interpersonal disengagement, stress, resilience, anxiety, and depression', 'interpersonal disengagement, resilience, and mindfulness', 'total burnout']","[{'cui': 'C0079920', 'cui_str': 'Occupational Health'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0334898', 'cui_str': 'Neonatologist'}, {'cui': 'C0334897', 'cui_str': 'Obstetrician'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",18.0,0.0183,"t -tests revealed statistically significant improvements in burnout, professional fulfillment, interpersonal disengagement, stress, resilience, anxiety, and depression at post-program compared with baseline ( N  = 12,","[{'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Scheid', 'Affiliation': ""Brigham and Women's Hospital.""}, {'ForeName': 'Natalie L', 'Initials': 'NL', 'LastName': 'Dyer', 'Affiliation': 'Kripalu Center for Yoga & Health.'}, {'ForeName': 'Jeffery A', 'Initials': 'JA', 'LastName': 'Dusek', 'Affiliation': 'Kripalu Center for Yoga & Health.'}, {'ForeName': 'Sat Bir S', 'Initials': 'SBS', 'LastName': 'Khalsa', 'Affiliation': ""Brigham and Women's Hospital.""}]",Workplace health & safety,['10.1177/2165079920930720']
2493,32812846,Impact of Virtual Reality-Generated Construction Environments at Different Heights on Postural Stability and Fall Risk.,"BACKGROUND


Falls due to postural instability are common in construction environments especially from a height. The purpose of the study was to investigate the impact of virtual reality (VR)-generated environments at different virtual heights on postural stability.
METHODS


Nineteen adults were analyzed for postural stability, tested in real (No VR) environment and in three VR environments, randomly assigned, at virtual heights of 0 ft. (VR0), 40 ft. (VR40), and 120 ft. (VR120). Postural stability was quantified using center of pressure postural sway variables and analyzed using a repeated measures analysis of variance (ANOVA). Participants also completed a simulation sickness questionnaire (SSQ) before and after VR exposure and a presence questionnaire (PQ) after VR exposure.
FINDINGS


Significant postural instability ( p  < .05) was identified between VR and No VR, in which increased postural instability was evident in all VR conditions compared with No VR. Scores from SSQ were within a pre-post score difference of five and the PQ score was (104.21 ± 14.03).
CONCLUSION/APPLICATION TO PRACTICE


Findings suggest that VR environments, regardless of virtual height, induced increased postural instability, which can be attributed to visual sensory conflicts to the postural control system created by VR exposure. Participants' subjective responses on SSQ and PQ confirmed the feasibility of using VR to represent realistic immersions in virtual heights. However, objectively, VR could potentially lead to postural instability, stressing caution. VR can be a potential tool for providing virtual high-altitude environment exposure for fall prevention training, however, more research is needed on postural adaptation with acute and chronic exposure to VR.",2020,"FINDINGS


Significant postural instability ( p  < .05) was identified between VR and No VR, in which increased postural instability was evident in all VR conditions compared with No VR.","['Nineteen adults were analyzed for postural stability, tested in real (No VR) environment and in three VR environments, randomly assigned, at virtual heights of 0 ft']","['Virtual Reality-Generated Construction Environments', 'virtual reality (VR)-generated environments']","['simulation sickness questionnaire (SSQ', 'Postural Stability and Fall Risk', 'Postural stability', 'postural instability']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0403066', 'cui_str': 'Construction worker'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C1843921', 'cui_str': 'Postural instability'}]",19.0,0.0129254,"FINDINGS


Significant postural instability ( p  < .05) was identified between VR and No VR, in which increased postural instability was evident in all VR conditions compared with No VR.","[{'ForeName': 'Harish', 'Initials': 'H', 'LastName': 'Chander', 'Affiliation': 'Mississippi State University.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Shojaei', 'Affiliation': 'Mississippi State University.'}, {'ForeName': 'Shuchisnigdha', 'Initials': 'S', 'LastName': 'Deb', 'Affiliation': 'The University of Texas at Arlington.'}, {'ForeName': 'Sachini N K', 'Initials': 'SNK', 'LastName': 'Kodithuwakku Arachchige', 'Affiliation': 'Mississippi State University.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Hudson', 'Affiliation': 'Mississippi State University.'}, {'ForeName': 'Adam C', 'Initials': 'AC', 'LastName': 'Knight', 'Affiliation': 'Mississippi State University.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Carruth', 'Affiliation': 'Mississippi State University.'}]",Workplace health & safety,['10.1177/2165079920934000']
2494,32812876,Comparison of contact surface areas of metatarsal diaphyseal osteotomies for correction of hallux valgus: Experimental study.,"OBJECTIVE


This study aimed to determine, pre-correction, the potential change in the osteotomy-site bony contact surface area that would occur during standard metatarsal diaphyseal procedures with the Baran-Unal modification of Mau osteotomy and then to compare it, post-correction, with the actual osteotomy-site bony contact surface area changes for a standard degree of deformity correction.
METHODS


A total of 30 standard, same sized, biomechanically equivalent, left first metatarsal sawbones were included in this experimental study. They were divided equally into five groups for each of the planned osteotomy techniques: Myerson's modification of Ludloff, Mau, scarf, Offset V, and Baran-Unal modification of Mau osteotomy. The normal osteotomy for each sample was considered as the control, while the corrective osteotomy was the test. Computerized tomography scans and three-dimensional (3D) reconstruction imaging were performed for objective and accurate measurements. The techniques of the osteotomy and post-corrective osteotomy bony contact surface areas were investigated by the two independent research assistants.
RESULTS


There was a statistically significant difference between the contact surface area changes of all pre- and post-corrective osteotomy groups (P<0.05). When the pre- and post-correction contact surface areas of any one group were compared with the other groups, the differences were or were not statistically significant. Mean differences between pre-correction and post-correction areas for Ludloff, Mau, scarf, Offset V, and Baran-Unal osteotomies were 180.7, 122.3, 226.2, 191.9, and 68.9 mm2, and the percentages of area loss were 22.9%, 15.5%, 28.6%, 24.3%, and 8.7%, respectively. The most bony contact area was found in the scarf osteotomy group (mean pre-correction area: 490.5 mm2 and mean post-correction area: 264.3 mm2), but the Baran-Unal modification group has significantly the highest post-correction bony contact area among the all other groups (mean pre-correction area: 413.3 mm2 and mean post-correction area: 344.4 mm2).
CONCLUSION


Metatarsal diaphyseal osteotomies for hallux valgus deformity have the potential not only for deformity correction, but also for contact surface area preservation. This study reaffirms the considerable potential of this new Baran-Unal modification to confer outstanding contact surface area values, even with the operative correction of hallux valgus deformity.",2020,There was a statistically significant difference between the contact surface area changes of all pre- and post-corrective osteotomy groups (P<0.05).,[],"['Metatarsal diaphyseal osteotomies', 'metatarsal diaphyseal osteotomies', ""planned osteotomy techniques: Myerson's modification of Ludloff, Mau, scarf, Offset V, and Baran-Unal modification of Mau osteotomy"", 'Computerized tomography scans and three-dimensional (3D) reconstruction imaging']","['percentages of area loss', 'Ludloff, Mau, scarf, Offset V, and Baran-Unal osteotomies']",[],"[{'cui': 'C0025584', 'cui_str': 'Metatarsal bone structure'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0452258', 'cui_str': 'Scarf'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0452258', 'cui_str': 'Scarf'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]",,0.0176908,There was a statistically significant difference between the contact surface area changes of all pre- and post-corrective osteotomy groups (P<0.05).,"[{'ForeName': 'A Meriç', 'Initials': 'AM', 'LastName': 'Ünal', 'Affiliation': 'Department of Sports Medicine, Süleyman Demirel University, School of Medicine, Isparta, Turkey;Clinic of Orthopaedics and Traumatology, Isparta City Hospital, Isparta, Turkey.'}, {'ForeName': 'Aydın', 'Initials': 'A', 'LastName': 'Budeyri', 'Affiliation': 'Department of Orthopaedics and Traumatology, SANKO University, School of Medicine, Gaziantep, Turkey.'}, {'ForeName': 'Bahattin', 'Initials': 'B', 'LastName': 'Baykal', 'Affiliation': 'Department of Radiology, Süleyman Demirel University, School of Medicine, Isparta, Turkey.'}]",Acta orthopaedica et traumatologica turcica,['10.5152/j.aott.2020.17481']
2495,32812886,Promoting Physical Activity With Self-Tracking and Mobile-Based Coaching for Cardiac Surgery Patients During the Discharge-Rehabilitation Gap: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Home-based cardiac rehabilitations (CRs) with digital technologies have been researched and implemented to replace, augment, and complement traditional center-based CR in recent years with considerable success. One problem that technology-enhanced home-based CR can potentially address is the gap between cardiac interventions and formal CR programs. In the Netherlands and some other countries (eg, Australia), patients after cardiac interventions stay at home for 3-4 weeks without much support from their physicians, and often engage in very little physical activity (PA). A home-based exercise program enabled by digital technologies may help patients to better prepare for the later center-based CR programs, potentially increasing the uptake rate of those programs.
OBJECTIVE


In a randomized controlled trial (RCT), we will evaluate the effectiveness of a home-based walking exercise program enhanced by self-tracking and mobile-based coaching (treatment condition), comparing it with a version of the same program without these technologies (control condition). The added value of the digital technologies is justified if patients in the treatment group walk more steps on average (primary outcome) and show better physical fitness in a bicycle ergometer test and higher self-efficacy toward PA (secondary outcomes).
METHODS


Based on a power analysis, we will recruit 100 cardiac patients and assign them evenly to the 2 parallel groups. Eligible patients are those who are scheduled in the postanesthesia care unit, know the Dutch language, have basic literacy of using smartphones, and are without medical conditions that may increase risks associated with PA. In a face-to-face meeting with a nurse practitioner, all patients are prescribed a 3-week exercise program at home (2 walking exercises per day with increasing duration), based on national and international guidelines and tailored to their physical conditions after cardiac intervention. Their physical activities (daily steps) will be measured by the Axivity AX3 accelerometer worn at hip position. Patients in the treatment group will also be supported by a Neo Health One self-tracking device and a mobile platform called Heart Angel, through which they are monitored and coached by their nurses. After the study, all patients will perform a bicycle ergometer test and return the devices within 1 week. In addition, 5 questionnaires will be sent to the patients by emails to assess their self-efficacy toward PA and other psychological states for exploratory analyses (at discharge, at the end of each monitoring week, and 1 week after the study). To minimize bias, the randomization procedure will be performed after introducing the exercise program, so the nurse practitioners are blind to the experimental conditions until that point.
RESULTS


The study protocol has been approved by the Medical Research Ethics Committees United on February 26, 2018 (NL 62142.100.17/R17.51). By the end of 2018, we completed a small pilot study with 8 patients and the results based on interviews and app usage data suggest that a larger clinical trial with the targeted population is feasible. We expect to complete the RCT by the end of 2021, and statistical analyses will follow.
CONCLUSIONS


Results of the RCT will help us to test the hypothesized benefits of self-tracking and mobile-based coaching for cardiac patients in home-based exercise programs during the discharge-rehabilitation gap. If the results are positive, cost-effectiveness analysis will be performed based on the insights of the study to inform the translation of the technology-enhanced program to clinical practice. We also note limitations of the trial in the discussion.
TRIAL REGISTRATION


Registered at Netherlands Trial Register NL8040; https://www.trialregister.nl/trial/8040.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/16737.",2020,"The added value of the digital technologies is justified if patients in the treatment group walk more steps on average (primary outcome) and show better physical fitness in a bicycle ergometer test and higher self-efficacy toward PA (secondary outcomes).
","['Eligible patients are those who are scheduled in the postanesthesia care unit, know the Dutch language', 'Cardiac Surgery Patients', '100 cardiac patients and assign them evenly to the 2 parallel groups']","['RCT', 'Self-Tracking and Mobile-Based Coaching', 'exercise program at home (2 walking exercises per day with increasing duration', 'home-based walking exercise program enhanced by self-tracking and mobile-based coaching (treatment condition']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0262723', 'cui_str': 'Postanesthesia care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0376241', 'cui_str': 'Dutch language'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",[],100.0,0.045334,"The added value of the digital technologies is justified if patients in the treatment group walk more steps on average (primary outcome) and show better physical fitness in a bicycle ergometer test and higher self-efficacy toward PA (secondary outcomes).
","[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Eindhoven University of Technology, Eindhoven, Netherlands.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Soliman-Hamad', 'Affiliation': 'Catharina Ziekenhuis Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'Roxanne', 'Initials': 'R', 'LastName': 'Robijns', 'Affiliation': 'Scamander, Utrecht, Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Verberkmoes', 'Affiliation': 'Catharina Ziekenhuis Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Verstappen', 'Affiliation': 'Catharina Ziekenhuis Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'Wijnand A', 'Initials': 'WA', 'LastName': 'IJsselsteijn', 'Affiliation': 'Eindhoven University of Technology, Eindhoven, Netherlands.'}]",JMIR research protocols,['10.2196/16737']
2496,32807727,Patterns of Cancer Progression of Metastatic Hormone-sensitive Prostate Cancer in the ECOG3805 CHAARTED Trial.,"BACKGROUND


ECOG3805 is a randomized trial of testosterone suppression with or without docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC). Deeper prostate-specific antigen (PSA) suppression is prognostic for outcome. However, the concordance of PSA rise and radiographic progression has not been examined previously in mHSPC, whereas this has been reported in metastatic castration-resistant prostate cancer.
OBJECTIVE


To determine the patterns of progression by PSA and radiographic parameters in patients in ECOG3805.
DESIGN, SETTING, AND PARTICIPANTS


We conducted a retrospective analysis of all patients in ECOG3805. Patients were classified according to the PSA level at progression (whether PSA level was below 2.0 ng/mL or not) and the type of progression event in the study (either PSA progression as defined by the study with or without clinical progression, or clinical progression alone). Baseline demographics, clinical outcomes, and patterns of progression were compared between the groups.
RESULTS AND LIMITATIONS


One in eight patients had clinical progression below a PSA level of 2 ng/mL, and approximately 25% developed clinical progression in the absence of confirmed PSA progression. Overall survival from randomization was shorter in patients with clinical progression without confirmed PSA progression than in patients with PSA progression alone as the first progression. Patient demographics at study entry were not predictive of the pattern of progression. Study limitations include its retrospective and post hoc nature.
CONCLUSIONS


Clinical progression prior to PSA rise or at low PSA levels is a relatively frequent phenomenon in mHSPC and is associated with poorer overall survival. Further biological and clinical studies of these patients are warranted.
PATIENT SUMMARY


Reliance on prostate-specific antigen (PSA) alone is an inadequate strategy to monitor patients undergoing treatment for metastatic hormone-sensitive prostate cancer. Prostate cancer can get worse on scans even with low PSA and/or no or small changes in PSA. Imaging should be added to PSA testing to monitor patients with metastatic prostate cancer.",2020,Overall survival from randomization was shorter in patients with clinical progression without confirmed PSA progression than in patients with PSA progression alone as the first progression.,"['Patients were classified according to the PSA level at progression (whether PSA level was below 2.0\u2009ng/mL or not) and the type of progression event in the study (either PSA progression as defined by the study with or without clinical progression, or clinical progression alone', 'patients with metastatic prostate cancer', 'all patients in ECOG3805', 'patients undergoing treatment for metastatic hormone-sensitive prostate cancer', 'metastatic hormone-sensitive prostate cancer (mHSPC', 'patients in ECOG3805']",['testosterone suppression with or without docetaxel'],"['clinical progression below a PSA level', 'Overall survival', 'overall survival', 'Baseline demographics, clinical outcomes, and patterns of progression', 'clinical progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0936223', 'cui_str': 'Prostate cancer metastatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",,0.0323714,Overall survival from randomization was shorter in patients with clinical progression without confirmed PSA progression than in patients with PSA progression alone as the first progression.,"[{'ForeName': 'Alan H', 'Initials': 'AH', 'LastName': 'Bryce', 'Affiliation': 'Division of Hematology and Medical Oncology, Mayo Clinic, Phoenix, AZ, USA. Electronic address: Bryce.alan@mayo.edu.'}, {'ForeName': 'Yu Hui', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Carbone Cancer Center, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Carducci', 'Affiliation': 'Department of Oncology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Jarrard', 'Affiliation': 'Department of Urology, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Garcia', 'Affiliation': 'Department of Medicine, Case Comprehensive Cancer Center, Cleveland, OH, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Dreicer', 'Affiliation': 'Nevada Cancer Research Foundation, Las Vegas, NV, USA.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Division of Hematology Oncology, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Mario Alfredo', 'Initials': 'MA', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Urology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Plimack', 'Affiliation': 'Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'Nevada Cancer Research Foundation, Las Vegas, NV, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'DiPaola', 'Affiliation': 'College of Medicine, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Harshman', 'Affiliation': 'Department of Medicine, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Sweeney', 'Affiliation': 'Division of Hematology/Oncology, University of Virginia Cancer Center, USA.'}]",European urology oncology,['10.1016/j.euo.2020.07.001']
2497,32807749,"CSP01, a Novel Superabsorbent Hydrogel, Reduces Colonic Transit Time in Patients With Chronic Idiopathic Constipation in a Randomized, Doubleblind, Controlled Pilot Clinical Trial.","Background/Aims


CSP01 is a novel superabsorbent hydrogel that absorbs gastrointestinal fluids and maintains high viscoelastic properties into the colon, where these fluids are released.
Methods


We conducted a 3 week-long single-center, randomized, double-blind, parallel-group, placebocontrolled pilot study comparing change in colonic transit time (CTT) among patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) treated for 21 days with either CSP01 hydrogel, active control (carboxymethylcellulose [CMC]) or placebo. CTT was measured using pre-treatment (7 days baseline) and end-of-treatment (last 7 days of treatment) wireless motility capsule transit testing. The primary endpoint was change in CTT.
Results


Forty subjects (20 CSP01; 11 CMC; 9 placebo) were enrolled and 38 completed the study. There was no significant change in mean CTT by treatment group ( P  = 0.297). In the placebo group, CTT increased by 15.3 minutes between baseline and end of treatment, increased by 366.4 minutes for CMC, and decreased by 727.4 minutes for CSP01. In post hoc analyses among those with CIC, mean CTT decreased by 1079 minutes for CSP01 ( P  = 0.025 compared to placebo), 919 minutes for CMC ( P  = 0.117 compared to placebo) and increased by 1113 minutes for placebo. Among patients with IBS-C, there was no significant difference in change in CTT for any treatment group. One subject in the CSP01 arm developed back pain attributed to constipation and withdrew without a second CTT measurement; there were no other adverse events.
Conclusion


CSP01 significantly decreased CTT compared to placebo among patients with CIC, but not IBSC.",2020,"In the placebo group, CTT increased by 15.3 minutes between baseline and end of treatment, increased by 366.4 minutes for CMC, and decreased by 727.4 minutes for CSP01.","['Patients With Chronic Idiopathic Constipation', 'Forty subjects (20 CSP01; 11 CMC; 9 placebo) were enrolled and 38 completed the study', 'patients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) treated for 21 days with either']","['CSP01 hydrogel, active control (carboxymethylcellulose [CMC]) or placebo', 'CSP01, a Novel Superabsorbent Hydrogel', 'placebocontrolled', 'placebo']","['CTT', 'change in CTT', 'mean CTT', 'back pain', 'Colonic Transit Time', 'colonic transit time (CTT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267509', 'cui_str': 'Chronic idiopathic constipation'}, {'cui': 'C0065772', 'cui_str': 'MCC protocol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007068', 'cui_str': 'Carboxymethylcellulose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]",,0.296183,"In the placebo group, CTT increased by 15.3 minutes between baseline and end of treatment, increased by 366.4 minutes for CMC, and decreased by 727.4 minutes for CSP01.","[{'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Staller', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School Boston, MA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Barshop', 'Affiliation': 'Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Vélez', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School Boston, MA, USA.'}, {'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Bailey', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School Boston, MA, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Locascio', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Chiquette', 'Affiliation': 'Gelesis Inc, Boston, MA, USA.'}, {'ForeName': 'Braden', 'Initials': 'B', 'LastName': 'Kuo', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital and Harvard Medical School Boston, MA, USA.'}]",Journal of neurogastroenterology and motility,['10.5056/jnm20001']
2498,32808025,"The effects of bi-anodal tDCS over the prefrontal cortex regions with extracephalic references placement on insight levels, cardio-respiratory and autonomic functions in schizophrenia patients and exploratory biomarker analyses for treatment response.","BACKGROUND


We have previously shown the efficacy of bi-anodal transcranial direct current stimulation (tDCS) over the prefrontal cortex (PFC) regions with extracephalic references placement in improving negative symptoms in schizophrenia. In this ancillary investigation, the effects of this intervention on insight levels, other clinical outcomes, cardio-respiratory and autonomic functions were examined and the potential of biomarkers for treatment response was explored.
METHODS


Schizophrenia patients were randomly allocated to receive 10 sessions of bi-anodal tDCS over the PFC regions with extracephalic references placement (2 mA, 20 min, twice daily for five weekdays) or sham stimulation. We examined, in 60 patients at baseline, immediately after stimulation and at follow-up visits, the insight levels, other clinical outcomes, blood pressure, respiratory rate, heart rate, and heart rate variability (HRV).
RESULTS


Insight levels as assessed by the abbreviated version of the Scale to Assess Unawareness in Mental Disorder in schizophrenia (SUMD) awareness of the disease, positive and negative symptoms dimensions and beliefs about medication compliance as assessed by Medication Adherence Rating Scale (MARS) were significantly enhanced by active stimulation relative to sham. No effects were observed on cognitive insight, other clinical outcomes, cardio-respiratory and autonomic functions. HRV indices as biomarkers were not associated with the clinical response to the intervention.
CONCLUSIONS


Our results provide evidence for bi-anodal tDCS over the PFC regions with extracephalic references placement in heightening the levels of insight into the disease and symptoms as well as and beliefs about medication compliance in schizophrenia, without impacting other clinical outcomes and cardio-respiratory/autonomic functions.",2020,"No effects were observed on cognitive insight, other clinical outcomes, cardio-respiratory and autonomic functions.","['schizophrenia patients', 'Schizophrenia patients']","['bi-anodal tDCS', '10 sessions of bi-anodal tDCS over the PFC regions with extracephalic references placement (2 mA, 20\xa0min, twice daily for five weekdays) or sham stimulation', 'extracephalic references placement', 'bi-anodal transcranial direct current stimulation (tDCS']","['blood pressure, respiratory rate, heart rate, and heart rate variability (HRV', 'cognitive insight, other clinical outcomes, cardio-respiratory and autonomic functions', 'Medication Adherence Rating Scale (MARS', 'insight levels, cardio-respiratory and autonomic functions']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.0288272,"No effects were observed on cognitive insight, other clinical outcomes, cardio-respiratory and autonomic functions.","[{'ForeName': 'Chuan-Chia', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chen', 'Initials': 'YC', 'LastName': 'Kao', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Che-Yi', 'Initials': 'CY', 'LastName': 'Chao', 'Affiliation': 'Department of Psychiatry, Cardinal Tien Hospital, New Taipei, Taiwan.'}, {'ForeName': 'Nian-Sheng', 'Initials': 'NS', 'LastName': 'Tzeng', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Hsin-An', 'Initials': 'HA', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}]",The international journal of neuropsychopharmacology,['10.1093/ijnp/pyaa063']
2499,32152915,Understanding the Oral Absorption of Irbesartan Using Biorelevant Dissolution Testing and PBPK Modeling.,"Poorly soluble weak bases form a significant proportion of the drugs available in the market thereby making it imperative to understand their absorption behavior. This work aims to mechanistically understand the oral absorption behavior for a weakly basic drug, Irbesartan (IRB), by investigating its pH dependent solubility, supersaturation, and precipitation behavior. Simulations performed using the equilibrium solubility could not accurately predict oral absorption. A multi-compartmental biorelevant dissolution testing model was used to evaluate dissolution in the stomach and duodenal compartment and mimic oral drug administration. This model exhibited sustained intestinal supersaturation (2-4-fold) even upon varying flow rates (4 mL/min, 7 mL/min, and mono-exponential transfer) from gastric to intestinal compartment. Simulation of oral absorption using GastroPlus™ and dissolution data collectively predicted plasma exposure with higher accuracy (% prediction error values within ± 15%), thereby indicating that multi-compartment dissolution testing enabled an improved prediction for oral pharmacokinetics of Irbesartan. Additionally, precipitates obtained in the intestinal compartment were characterized to determine the factors underlying intestinal supersaturation of Irbesartan. The solid form of these precipitates was amorphous with considerable particle size reduction. This indicated that following gastric transit, precipitate formation in the amorphous form coupled with an approximately 10 times particle size reduction could be potential factors leading to the generation and sustenance of intestinal drug supersaturation.",2020,"Simulation of oral absorption using GastroPlus™ and dissolution data collectively predicted plasma exposure with higher accuracy (% prediction error values within ± 15%), thereby indicating that multi-compartment dissolution testing enabled an improved prediction for oral pharmacokinetics of Irbesartan.",[],[],[],[],[],[],,0.0236388,"Simulation of oral absorption using GastroPlus™ and dissolution data collectively predicted plasma exposure with higher accuracy (% prediction error values within ± 15%), thereby indicating that multi-compartment dissolution testing enabled an improved prediction for oral pharmacokinetics of Irbesartan.","[{'ForeName': 'Navpreet', 'Initials': 'N', 'LastName': 'Kaur', 'Affiliation': 'Department of Pharmaceutics, College of Pharmacy, University of Minnesota-Twin Cities, Minneapolis, Minnesota, 55455, USA.'}, {'ForeName': 'Poonam Singh', 'Initials': 'PS', 'LastName': 'Thakur', 'Affiliation': 'Novartis Healthcare Private Limited, Hyderabad, 500081, India.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Shete', 'Affiliation': 'Lupin Limited (Research Park), Pune, Maharashtra, 412115, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Gangwal', 'Affiliation': 'Glenmark Pharmaceuticals Limited, Navi Mumbai, Maharashtra, 400026, India.'}, {'ForeName': 'Abhay T', 'Initials': 'AT', 'LastName': 'Sangamwar', 'Affiliation': 'Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, S.A.S. Nagar, (Mohali), Punjab, 160062, India.'}, {'ForeName': 'Arvind Kumar', 'Initials': 'AK', 'LastName': 'Bansal', 'Affiliation': 'Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research, S.A.S. Nagar, (Mohali), Punjab, 160062, India. akbansal@niper.ac.in.'}]",AAPS PharmSciTech,['10.1208/s12249-020-01643-x']
2500,32170867,Phase 2 study of hyper-CMAD with liposomal vincristine for patients with newly diagnosed acute lymphoblastic leukemia.,"Liposomal vincristine is designed to reduce neurotoxicity and increase dose intensity delivery, and has been approved as salvage therapy in relapsed/refractory acute lymphoblastic leukemia (ALL). Our aim was to evaluate the response rate, toxicities, and outcome of adults with newly diagnosed ALL who received liposomal vincristine, rather than regular vincristine in combination with intensive chemotherapy (Hyper-CMAD). In a single-center, phase 2 study, patients ≥18 years with newly-diagnosed B-cell ALL were eligible to receive hyper-CMAD alternating with high-dose methotrexate and cytarabine. Rituximab was administered in CD20 positive ALL. Tyrosine kinase inhibitors (imatinib or dasatinib) were added in Philadelphia chromosome-positive (Ph-positive) ALL. Thirty-one patients were enrolled, median follow-up of 59 months (0.3-70). Thirteen patients (42%) had CD20 positive ALL, and 21 (68%) had Ph-positive ALL. Thirty (97%) achieved complete remission (CR). All 26 patients with abnormal karyotype achieved complete cytogenetic response (CCyR), and 27/30 (90%) achieved negative minimal residual disease status by multicolor flow cytometry. Of 20 evaluable Ph-positive ALL patients, major molecular response (MMR) was achieved in 19 patients (95%); complete molecular response (CMR) in 14 (70%). Grade 3/4 peripheral neuropathy was observed in five (16%) with all grade peripheral neuropathy in 21 (68%). With a median follow-up of 59 months, 21 (68%) patients are alive. The 5-year CR duration and survival rates were 73% and 61%, respectively. Ten (32%) patients died: one, sepsis on C1D10; four, unknown; one, post-transplant complications; four, relapse. Hyper-CMAD with liposomal vincristine is safe and demonstrated high response and survival rates in newly diagnosed ALL.",2020,Hyper-CMAD with liposomal vincristine is safe and demonstrated high response and survival rates in newly diagnosed ALL.,"['Thirty-one patients were enrolled, median follow-up of 59\u2009months (0.3-70', 'patients ≥18\u2009years with newly-diagnosed B-cell ALL were eligible to receive', 'relapsed/refractory acute lymphoblastic leukemia (ALL', 'adults with newly diagnosed ALL who received', 'patients with newly diagnosed acute lymphoblastic leukemia']","['liposomal vincristine, rather than regular vincristine in combination with intensive chemotherapy (Hyper-CMAD', 'Liposomal vincristine', 'Tyrosine kinase inhibitors (imatinib or dasatinib', 'Rituximab', 'hyper-CMAD with liposomal vincristine', 'liposomal vincristine', 'hyper-CMAD alternating with high-dose methotrexate and cytarabine']","['complete molecular response (CMR', 'negative minimal residual disease status by multicolor flow cytometry', 'survival rates', 'complete remission (CR', 'Grade 3/4 peripheral neuropathy', 'complete cytogenetic response (CCyR', 'major molecular response (MMR', 'CD20 positive ALL', '5-year CR duration and survival rates', 'response rate, toxicities']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1292769', 'cui_str': 'Precursor B-cell lymphoblastic leukemia'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1519991', 'cui_str': 'vincristine liposome'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1455147', 'cui_str': 'dasatinib'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}]","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0016263', 'cui_str': 'Flow cytometry'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",31.0,0.0702764,Hyper-CMAD with liposomal vincristine is safe and demonstrated high response and survival rates in newly diagnosed ALL.,"[{'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Sasaki', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Hagop', 'Initials': 'H', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Wierda', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ravandi-Kashani', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Jorgensen', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Sa A', 'Initials': 'SA', 'LastName': 'Wang', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Khoury', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Naval', 'Initials': 'N', 'LastName': 'Daver', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Burger', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Courtney D', 'Initials': 'CD', 'LastName': 'Di Nardo', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Short', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Zeev', 'Initials': 'Z', 'LastName': 'Estrov Md', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Konopleva Md PhD', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Maro', 'Initials': 'M', 'LastName': 'Ohanian DO', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Kadia', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Yesid', 'Initials': 'Y', 'LastName': 'Alvarado-Valero', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Musa', 'Initials': 'M', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Sherry', 'Initials': 'S', 'LastName': 'Pierce', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Garris', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Ingram', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Cortes', 'Affiliation': 'Georgia Cancer Center, Augusta, Georgia, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'OʼBrien', 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California Irvine, Orange, California, USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Jabbour', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, Texas, USA.'}]",American journal of hematology,['10.1002/ajh.25784']
2501,31300578,Predicting Knee Pain and Knee Osteoarthritis Among Overweight Women.,"BACKGROUND


There is a need for prediction of knee osteoarthritis (KOA) in general practice to motivate subjects for preventive therapies and optimize preventive trials.
AIM


To develop a prediction model, with questionnaire and physical examination variables, for incident frequent knee pain (FKP) and symptomatic KOA after 2.5 and/or 6.5 years among overweight and obese middle-aged women.
DESIGN AND SETTING


Models were developed in the Prevention of Knee Osteoarthritis in Overweight Females study (age 50 to 60 years, body mass index [BMI] ≥ 27 kg/m 2 ) (ISRCTN 42823086). FKP was defined as knee pain during most days in the past month. Symptomatic KOA was defined according to the combined (clinical and radiographic) American College of Rheumatology criteria.
METHOD


Multivariable analysis by backward stepwise deletion was performed for questionnaire and physical examination variables. The prediction model was externally validated in Rotterdam Study (RS)-III. Area under the curves (AUCs) of receiver operating characteristic were calculated.
RESULTS


32% of 237 women (mean age 55.7 ± 3.2 years; mean BMI, 31.9 ± 3.8 kg/m 2 ) developed FKP and 30% developed symptomatic KOA. AUC of age and BMI was 0.63 (0.55 to 0.71) for incident FKP. The final model included age, BMI, mild knee symptoms, knee problems climbing stairs, morning stiffness, postmenopausal status, and heavy work. AUC was 0.71 (0.63 to 0.78). Results were similar for incident KOA. Applying external validation, similar results were observed in the RS-III.
CONCLUSION


In this study, easy-obtainable variables modestly improved the prediction of FKP and symptomatic KOA above age and BMI. To improve the identification of high-risk individuals, development of valid tests for other known risk factors, like meniscal damage, that are applicable in primary care, are urgently needed.",2019,"The final model included age, BMI, mild knee symptoms, knee problems climbing stairs, morning stiffness, postmenopausal status, and heavy work.","['American College of Rheumatology criteria', '32% of 237 women (mean age 55.7 ± 3.2 years', 'Models were developed in the Prevention of Knee Osteoarthritis in Overweight Females study (age 50 to 60 years, body mass index', 'Overweight Women', 'incident frequent knee pain (FKP) and symptomatic KOA after 2.5 and/or 6.5 years among overweight and obese middle-aged women']",[],"['knee pain', 'symptomatic KOA', 'AUC of age and BMI']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}]",[],"[{'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0201937,"The final model included age, BMI, mild knee symptoms, knee problems climbing stairs, morning stiffness, postmenopausal status, and heavy work.","[{'ForeName': 'Marieke L A', 'Initials': 'MLA', 'LastName': 'Landsmeer', 'Affiliation': 'From the Department of General Practice, Erasmus MC, University Medical Center Rotterdam, the Netherlands (MLAL, JR, MvM, DS, PJEB, SMABZ); Department of Radiology & Nuclear Medicine, Erasmus MC, University Medical Center Rotterdam, the Netherlands (EHGO); Department of Orthopaedics, Erasmus MC, University Medical Center Rotterdam, the Netherlands (SMABZ). m.landsmeer@erasmusmc.nl.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Runhaar', 'Affiliation': 'From the Department of General Practice, Erasmus MC, University Medical Center Rotterdam, the Netherlands (MLAL, JR, MvM, DS, PJEB, SMABZ); Department of Radiology & Nuclear Medicine, Erasmus MC, University Medical Center Rotterdam, the Netherlands (EHGO); Department of Orthopaedics, Erasmus MC, University Medical Center Rotterdam, the Netherlands (SMABZ).'}, {'ForeName': 'Marienke', 'Initials': 'M', 'LastName': 'van Middelkoop', 'Affiliation': 'From the Department of General Practice, Erasmus MC, University Medical Center Rotterdam, the Netherlands (MLAL, JR, MvM, DS, PJEB, SMABZ); Department of Radiology & Nuclear Medicine, Erasmus MC, University Medical Center Rotterdam, the Netherlands (EHGO); Department of Orthopaedics, Erasmus MC, University Medical Center Rotterdam, the Netherlands (SMABZ).'}, {'ForeName': 'Edwin H G', 'Initials': 'EHG', 'LastName': 'Oei', 'Affiliation': 'From the Department of General Practice, Erasmus MC, University Medical Center Rotterdam, the Netherlands (MLAL, JR, MvM, DS, PJEB, SMABZ); Department of Radiology & Nuclear Medicine, Erasmus MC, University Medical Center Rotterdam, the Netherlands (EHGO); Department of Orthopaedics, Erasmus MC, University Medical Center Rotterdam, the Netherlands (SMABZ).'}, {'ForeName': 'Dieuwke', 'Initials': 'D', 'LastName': 'Schiphof', 'Affiliation': 'From the Department of General Practice, Erasmus MC, University Medical Center Rotterdam, the Netherlands (MLAL, JR, MvM, DS, PJEB, SMABZ); Department of Radiology & Nuclear Medicine, Erasmus MC, University Medical Center Rotterdam, the Netherlands (EHGO); Department of Orthopaedics, Erasmus MC, University Medical Center Rotterdam, the Netherlands (SMABZ).'}, {'ForeName': 'Patrick J E', 'Initials': 'PJE', 'LastName': 'Bindels', 'Affiliation': 'From the Department of General Practice, Erasmus MC, University Medical Center Rotterdam, the Netherlands (MLAL, JR, MvM, DS, PJEB, SMABZ); Department of Radiology & Nuclear Medicine, Erasmus MC, University Medical Center Rotterdam, the Netherlands (EHGO); Department of Orthopaedics, Erasmus MC, University Medical Center Rotterdam, the Netherlands (SMABZ).'}, {'ForeName': 'Sita M A', 'Initials': 'SMA', 'LastName': 'Bierma-Zeinstra', 'Affiliation': 'From the Department of General Practice, Erasmus MC, University Medical Center Rotterdam, the Netherlands (MLAL, JR, MvM, DS, PJEB, SMABZ); Department of Radiology & Nuclear Medicine, Erasmus MC, University Medical Center Rotterdam, the Netherlands (EHGO); Department of Orthopaedics, Erasmus MC, University Medical Center Rotterdam, the Netherlands (SMABZ).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2019.04.180302']
2502,32809843,"A Phase 2a, Double-Blind, Placebo-Controlled Randomized Trial of Inhaled TLR9 Agonist AZD1419 in Asthma.","RATIONALE


To examine the potential of TLR9 activation to modulate the Type-2 immune response in asthma.
OBJECTIVES


To evaluate efficacy and safety of AZD1419, an inhaled TLR9 agonist, in a phase 2a, randomized, double-blind trial.
METHODS


Adult asthma patients with a history of elevated eosinophils (>250 cells/μL) were randomized 1:1 to receive 13 once-weekly doses of inhaled AZD1419 (1, 4, or 8 mg; n=40) or placebo (n=41). Inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA) were tapered down and then discontinued. The last 4 doses of AZD1419 were given without maintenance medication, followed by a 40-week observation period. Primary endpoint was time to loss of asthma control (LOC).
MEASUREMENTS AND MAIN RESULTS


AZD1419 induced a Th1-type interferon response with a sustained reduction in markers of type 2 inflammation. However, there were no statistically significant differences between AZD1419 and placebo for time to LOC, proportion of patients with LOC, changes in ACQ-5, exacerbations, reliever use, FEV1, PEF or FeNO. LOC was predicted by an early rise in FeNO in 63% of patients. Despite withdrawal of maintenance treatment, 24 patients completed the study without LOC; AZD1419 n=11, placebo n=13. Adverse events (AEs) were balanced across groups, with no deaths or serious AEs judged as causally related to AZD1419.
CONCLUSIONS


AZD1419 was safe and well-tolerated but did not lead to improved asthma control, despite reducing markers of type 2 inflammation. Results suggest that a novel accelerated step-down approach based on FeNO is possible for well controlled asthma patients. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT02898662.",2020,"Adverse events (AEs) were balanced across groups, with no deaths or serious AEs judged as causally related to AZD1419.
","['asthma', 'Adult asthma patients with a history of elevated eosinophils (>250 cells/μL', '24 patients completed the study without LOC; AZD1419 n=11, placebo n=13', 'Asthma']","['Inhaled TLR9 Agonist AZD1419', 'Placebo', 'AZD1419', 'Inhaled corticosteroids (ICS) and long-acting β2-agonist (LABA', 'AZD1419 and placebo', 'inhaled AZD1419', 'placebo']","['time to loss of asthma control (LOC', 'ACQ-5, exacerbations, reliever use, FEV1, PEF or FeNO', 'Th1-type interferon response', 'safe and well-tolerated', 'Adverse events (AEs', 'markers of type 2 inflammation', 'LOC']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0030771', 'cui_str': 'Pefloxacin'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.655387,"Adverse events (AEs) were balanced across groups, with no deaths or serious AEs judged as causally related to AZD1419.
","[{'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Psallidas', 'Affiliation': 'Respiratory, Inflammation and Autoimmunity, Biopharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom of Great Britain and Northern Ireland; ioannis.psallidas@astrazeneca.com.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Backer', 'Affiliation': 'Center for Physical Activity Research, Rigshospitalet and Copenhagen University, Copenhagen, Denmark.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Kuna', 'Affiliation': 'Medical University of Lodz, Department of Internal Medicine, Asthma and Allergy, Lodz, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Palmér', 'Affiliation': 'Clinical Pharmacology, ADME and AI, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Necander', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmunity, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Aurell', 'Affiliation': 'AstraZeneca R&D, Research and Early Development, Respiratory, Inflammation and Autoimmunity, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Korsback', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmunity, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Ziad', 'Initials': 'Z', 'LastName': 'Taib', 'Affiliation': 'Early Clinical Biostatistics and Statistical Innovation, Data Science & AI, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Hashemi', 'Affiliation': 'Early Clinical Biostatistics and Statistical Innovation, Data Science & AI, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Gustafson', 'Affiliation': 'BioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Asimus', 'Affiliation': 'Clinical Pharmacology, ADME and AI, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Delaney', 'Affiliation': 'Bioscience, Research and Early Development, Respiratory, Inflammation and Autoimmunity, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Pardali', 'Affiliation': 'AstraZeneca, Respiratory, Inflammation and Autoimmune iMed, Molndal, Sweden.'}, {'ForeName': 'Fanyi', 'Initials': 'F', 'LastName': 'Jiang', 'Affiliation': 'Translational Science and Experimental Medicine, Research and Early Development, Respiratory, Inflammation and Autoimmunity, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Almquist', 'Affiliation': 'Clinical Pharmacology, ADME and AI, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Jackson', 'Affiliation': 'Dynavax Technologies Corp, 17601, Berkeley, California, United States.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coffman', 'Affiliation': 'Dynavax Technologies Corp, 17601, Berkeley, California, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Keeling', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmunity, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Tariq', 'Initials': 'T', 'LastName': 'Sethi', 'Affiliation': 'Respiratory, Inflammation and Autoimmunity, Biopharmaceuticals R&D, AstraZeneca, Cambridge, United Kingdom of Great Britain and Northern Ireland.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202001-0133OC']
2503,32809893,Legumain in Acute Coronary Syndromes: A Substudy of the PLATO (Platelet Inhibition and Patient Outcomes) Trial.,"Background The cysteine protease legumain is increased in patients with atherosclerosis, but its causal role in atherogenesis and cardiovascular disease is still unclear. The aim of the study was to investigate the association of legumain with clinical outcome in a large cohort of patients with acute coronary syndrome. Methods and Results Serum levels of legumain were analyzed in 4883 patients with acute coronary syndrome from a substudy of the PLATO (Platelet Inhibition and Patient Outcomes) trial. Levels were analyzed at admission and after 1 month follow-up. Associations between legumain and a composite of cardiovascular death, spontaneous myocardial infarction or stroke, and its individual components were assessed by multivariable Cox regression analyses. At baseline, a 50% increase in legumain level was associated with a hazard ratio (HR) of 1.13 (95% CI, 1.04-1.21),  P =0.0018, for the primary composite end point, adjusted for randomized treatment. The association remained significant after adjustment for important clinical and demographic variables (HR, 1.10; 95% CI, 1.02-1.19;  P =0.013) but not in the fully adjusted model. Legumain levels at 1 month were not associated with the composite end point but were negatively associated with stroke (HR, 0.62; 95% CI, 0.44-0.88;  P =0.0069), including in the fully adjusted model (HR, 0.57; 95% CI, 0.37-0.88;  P =0.0114). Conclusions Baseline legumain was associated with the primary outcome in patients with acute coronary syndrome, but not in the fully adjusted model. The association between high levels of legumain at 1 month and decreased occurrence of stroke could be of interest from a mechanistic point of view, illustrating the potential dual role of legumain during atherogenesis and acute coronary syndrome. Registration URL: https://www.clini​caltr​ials.gov; Unique identifier: NCT00391872.",2020,"Legumain levels at 1 month were not associated with the composite end point but were negatively associated with stroke (HR, 0.62; 95% CI, 0.44-0.88;  P =0.0069), including in the fully adjusted model (HR, 0.57; 95% CI, 0.37-0.88;  P =0.0114).","['patients with acute coronary syndrome', 'patients with atherosclerosis', 'Acute Coronary Syndromes', '4883 patients with acute coronary syndrome']",['Legumain'],"['Legumain levels', 'cardiovascular death, spontaneous myocardial infarction or stroke, and its individual components', 'legumain level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]","[{'cui': 'C0104398', 'cui_str': 'Legumain'}]","[{'cui': 'C0104398', 'cui_str': 'Legumain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",4883.0,0.097858,"Legumain levels at 1 month were not associated with the composite end point but were negatively associated with stroke (HR, 0.62; 95% CI, 0.44-0.88;  P =0.0069), including in the fully adjusted model (HR, 0.57; 95% CI, 0.37-0.88;  P =0.0114).","[{'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Gregersen', 'Affiliation': 'Research Institute for Internal Medicine Oslo University Hospital Rikshospitalet Oslo Norway.'}, {'ForeName': 'Annika E', 'Initials': 'AE', 'LastName': 'Michelsen', 'Affiliation': 'Research Institute for Internal Medicine Oslo University Hospital Rikshospitalet Oslo Norway.'}, {'ForeName': 'Ngoc Nguyen', 'Initials': 'NN', 'LastName': 'Lunde', 'Affiliation': 'Section of Pharmacology and Pharmaceutical Biosciences Department of Pharmacy University of Oslo Norway.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Åkerblom', 'Affiliation': 'Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center Uppsala University Uppsala Sweden.'}, {'ForeName': 'Tatevik G', 'Initials': 'TG', 'LastName': 'Lakic', 'Affiliation': 'Uppsala Clinical Research Center Uppsala University Uppsala Sweden.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Skjelland', 'Affiliation': 'Department of Neurology Oslo University Hospital Rikshospitalet Oslo Norway.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Ryeng Skagen', 'Affiliation': 'Department of Neurology Oslo University Hospital Rikshospitalet Oslo Norway.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Becker', 'Affiliation': 'Division of Cardiovascular Health and Disease Heart, Lung and Vascular Institute Academic Health Center Cincinnati OH.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lindbäck', 'Affiliation': 'Uppsala Clinical Research Center Uppsala University Uppsala Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Himmelmann', 'Affiliation': 'AstraZeneca Research and Development Gothenburg Sweden.'}, {'ForeName': 'Rigmor', 'Initials': 'R', 'LastName': 'Solberg', 'Affiliation': 'Section of Pharmacology and Pharmaceutical Biosciences Department of Pharmacy University of Oslo Norway.'}, {'ForeName': 'Harald T', 'Initials': 'HT', 'LastName': 'Johansen', 'Affiliation': 'Section of Pharmacology and Pharmaceutical Biosciences Department of Pharmacy University of Oslo Norway.'}, {'ForeName': 'Stefan K', 'Initials': 'SK', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center Uppsala University Uppsala Sweden.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Siegbahn', 'Affiliation': 'Uppsala Clinical Research Center Uppsala University Uppsala Sweden.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease University of Sheffield Sheffield United Kingdom.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Kontny', 'Affiliation': 'Department of Cardiology Stavanger University Hospital Stavanger Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Aukrust', 'Affiliation': 'Research Institute for Internal Medicine Oslo University Hospital Rikshospitalet Oslo Norway.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Ueland', 'Affiliation': 'Research Institute for Internal Medicine Oslo University Hospital Rikshospitalet Oslo Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center Uppsala University Uppsala Sweden.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Halvorsen', 'Affiliation': 'Research Institute for Internal Medicine Oslo University Hospital Rikshospitalet Oslo Norway.'}]",Journal of the American Heart Association,['10.1161/JAHA.120.016360']
2504,32809899,A multiple mediation analysis of the association between asynchronous use of music and running performance.,"The purpose of this study was to examine if the effects of asynchronous use of music on running performance are directly and/or indirectly carried through psychological, psychophysical, and psychophysiological benefits. Following a standardized music selection procedure, 20 healthy undergraduate students (10 males, 10 females) completed a 30-min treadmill run at perceived moderate intensity while listening to music (135-140 beats per minute) or under a no-music condition in a randomized order. Participants' affective valence, arousal, perceived exertion, heart rate during the run, and running distance were measured in both trials. A mediation analysis was conducted for 40 data collected from the 20 participants under two conditions (no music; music) with a parallel mediation model in which affective valence, arousal, heart rate, and perceived exertion were specified as mediators. A significant indirect effect of affective valence was observed for running distance. The present finding supports the notion that the relationship between asynchronous use of music and running distance is mediated by psychological benefits.",2020,A significant indirect effect of affective valence was observed for running distance.,"['40 data collected from the 20 participants under two conditions (no music; music) with a parallel mediation model in which affective valence, arousal, heart rate, and perceived exertion were specified as mediators', '20 healthy undergraduate students (10 males, 10 females']",['30-min treadmill run at perceived moderate intensity while listening to music (135-140 beats per minute) or under a no-music condition'],"['affective valence', 'affective valence, arousal, perceived exertion, heart rate during the run, and running distance']","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",20.0,0.334719,A significant indirect effect of affective valence was observed for running distance.,"[{'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kawabata', 'Affiliation': 'National Institute of Education, Nanyang Technological University , Singapore, Singapore.'}, {'ForeName': 'Khai Leng', 'Initials': 'KL', 'LastName': 'Chua', 'Affiliation': 'National Institute of Education, Nanyang Technological University , Singapore, Singapore.'}]",Journal of sports sciences,['10.1080/02640414.2020.1809153']
2505,32809900,Images depicting human pain increase exercise-induced pain and impair endurance cycling performance.,"The current study investigated whether viewing images of others in pain influences exercise-induced pain (EIP) and cycling performance. Twenty-one recreational cyclists attended five laboratory visits. The first two visits involved measuring participants' maximal aerobic capacity and familiarized participants to the fixed power (FP) and 16.1 km cycling time trial (TT) tasks. The FP task required participants to cycle at 70% of their maximal aerobic power for 10-minutes. In the subsequent three visits, participants performed the FP and TT tasks after viewing pleasant, ‎painful or neutral images. Participants rated the subset of painful images as more painful than the pleasant and neutral images; with no difference in the pain ratings of the pleasant and neutral images. In the FP task, EIP ratings were higher following painful compared to pleasant images, while no differences in EIP were observed between any other condition . In the TT, performance did not differ between the pleasant and neutral conditions. However, TT performance was reduced after viewing painful images compared to neutral or pleasant images. HR, B[La], perceived exertion and EIP did not differ between the three conditions. These results suggest that viewing painful images decreases TT performance and increases pain during fixed intensity cycling.‎.
ABBREVIATIONS


EIP: Exercise Induced Pain; FP: Fixed Power; TT: Time Trial; HR:Heart Rate; B[La]: Blood Lactate; RPE: Rating of Perceived Exertion; IAPS: International Affective Picture System; PO: Power Output.",2020,"In the FP task, EIP ratings were higher following painful compared to pleasant images, while no differences in EIP were observed between any other condition .",['Twenty-one recreational cyclists attended five laboratory visits'],[],"['pain and impair endurance cycling performance', 'fixed power (FP) and 16.1 km cycling time trial (TT) tasks', 'pain (EIP) and cycling performance', 'EIP', 'FP task, EIP ratings', 'HR, B[La], perceived exertion and EIP', 'pain ratings', 'TT performance and increases pain', 'FP and TT tasks', 'TT performance']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0715718,"In the FP task, EIP ratings were higher following painful compared to pleasant images, while no differences in EIP were observed between any other condition .","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Astokorki', 'Affiliation': 'College of Education-Shaqlawa, Salahaddin University-Erbil , Shaqlawa, Iraq.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Flood', 'Affiliation': 'Research Institute for Sport & Exercise, University of Canberra , Canberra, Australia.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Mauger', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, Faculty of Science, University of Kent , Chatham, UK.'}]",Journal of sports sciences,['10.1080/02640414.2020.1809162']
2506,32809950,"Correction: A Novel Narrative E-Writing Intervention for Parents of Children With Chronic Life-Threatening Illnesses: Protocol for a Pilot, Open-Label Randomized Controlled Trial.",[This corrects the article DOI: 10.2196/17561.].,2020,[This corrects the article DOI: 10.2196/17561.].,['Parents of Children With Chronic Life-Threatening Illnesses'],"['Correction', 'Narrative E-Writing Intervention']",[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.066439,[This corrects the article DOI: 10.2196/17561.].,"[{'ForeName': 'Andy Hau Yan', 'Initials': 'AHY', 'LastName': 'Ho', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Oindrila', 'Initials': 'O', 'LastName': 'Dutta', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Tan-Ho', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Toh Hsiang Benny', 'Initials': 'THB', 'LastName': 'Tan', 'Affiliation': 'School of Computer Science and Engineering, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Xinyi Casuarine', 'Initials': 'XC', 'LastName': 'Low', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Sashikumar', 'Initials': 'S', 'LastName': 'Ganapathy', 'Affiliation': 'Club Rainbow, Singapore, Singapore.'}, {'ForeName': 'Josip', 'Initials': 'J', 'LastName': 'Car', 'Affiliation': 'Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Ringo Moon-Ho', 'Initials': 'RM', 'LastName': 'Ho', 'Affiliation': 'Psychology Program, School of Social Sciences, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Chun Yan', 'Initials': 'CY', 'LastName': 'Miao', 'Affiliation': 'School of Computer Science and Engineering, Nanyang Technological University, Singapore, Singapore.'}]",JMIR research protocols,['10.2196/22286']
2507,32810077,"Blood pressure and cardiovascular risk factors in women treated for climacteric symptoms with acupuncture, phytoestrogens, or hormones.","OBJECTIVE


To evaluate the response of cardiovascular risk factors to the treatment of climacteric symptoms.
METHODS


In this prospective study, women reporting climacteric symptoms were randomized to 3 months of treatment with either acupuncture (n = 19), phytoestrogens (75 mg soy isoflavones, BID; n = 22), or low-dose hormone therapy (HT; 0.3 mg conjugated equine oestrogens plus 1.5 mg medroxyprogesterone acetate; n = 20). Greene's climacteric scale, blood pressure (BP), lipids, glucose, insulin, and homeostatic model assessment of insulin resistance were assessed before and after treatment. Observed changes were compared by analysis of variance.
RESULTS


HT and acupuncture reduced Greene climacteric score to a similar extent, but the effect of phytoestrogens was significantly lower (P < 0.05). With acupuncture, systolic (-7.4 ± 15.3 mm Hg; P < 0.05) and diastolic BP (-8.3 ± 7.7mm Hg; P < 0.01) decreased, and the same occurred with phytoestrogens (-8.4 ± 9.0 mm Hg [P < 0.01] and -6.6 ± 7.9 mm Hg [P < 0.01]). Neither BP systolic (1.9 ± 17.5 mm Hg) nor BP diastolic (-1.4 ± 9.6 mm Hg) changed during HT. Low-density lipoprotein cholesterol decreased with phytoestrogens (-9.9 ± 19.6 mg/dL; P < 0.05), and triglycerides increased with both HT (34.5 ± 12.2 mg/dL; P < 0.01) and phytoestrogens (17.41 ± 24.4 mg/dL; P < 0.01). A slight but significant increase in homeostatic model assessment of insulin resistance (0.14 ± 0.5; P < 0.05) was observed after HT.
CONCLUSIONS


Treatment of climacteric symptoms with acupuncture and phytoestrogens, but not HT, is associated with a clear BP reduction, and phytoestrogens with potentially positive alterations in low-density lipoprotein cholesterol level.
TRIAL REGISTRATION


EudractCT Number 2008-006053-41. : Video Summary:http://links.lww.com/MENO/A637.",2020,"A slight but significant increase in homeostatic model assessment of insulin resistance (0.14 ± 0.5; P < 0.05) was observed after HT.
","['women treated for climacteric symptoms with acupuncture, phytoestrogens, or hormones', 'women reporting climacteric symptoms']","['acupuncture', 'phytoestrogens (75\u200amg soy isoflavones, BID; n\u200a=\u200a22), or low-dose hormone therapy (HT', 'Video Summary:http://links.lww.com/MENO/A637', 'conjugated equine oestrogens plus 1.5\u200amg medroxyprogesterone acetate', 'acupuncture and phytoestrogens']","['Blood pressure and cardiovascular risk factors', 'triglycerides', 'homeostatic model assessment of insulin resistance', 'diastolic BP', 'Greene climacteric score', 'BP diastolic', ""Greene's climacteric scale, blood pressure (BP), lipids, glucose, insulin, and homeostatic model assessment of insulin resistance"", 'Low-density lipoprotein cholesterol', 'BP systolic']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C1306878', 'cui_str': 'Climacteric discomfort'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0071011', 'cui_str': 'Phytoestrogen'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0684224', 'cui_str': 'Report'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0071011', 'cui_str': 'Phytoestrogen'}, {'cui': 'C4076257', 'cui_str': 'Soy isoflavone'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0019944', 'cui_str': 'Equus caballus'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0065864', 'cui_str': 'Medroxyprogesterone acetate'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0008943', 'cui_str': 'Change of Life'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C1306620', 'cui_str': 'Blood pressure systolic'}]",,0.167643,"A slight but significant increase in homeostatic model assessment of insulin resistance (0.14 ± 0.5; P < 0.05) was observed after HT.
","[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Palma', 'Affiliation': 'Obstetrics and Gynecology Clinic, Azienda Ospedaliero Universitaria di Modena, Modena.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Fontanesi', 'Affiliation': 'Obstetrics and Gynecology Unit, Nuovo Ospedale Civile di Sassuolo, Sassuolo.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Neri', 'Affiliation': 'Obstetrics and Gynecology Clinic, Azienda Ospedaliero Universitaria di Modena, Modena.'}, {'ForeName': 'Anjeza', 'Initials': 'A', 'LastName': 'Xholli', 'Affiliation': 'Ginecologia e Ostetricia, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili, Università degli Studi di Genova, Ospedale Policlinico San Martino-IRCCS, Largo Benzi 3, Genova, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Facchinetti', 'Affiliation': 'Obstetrics and Gynecology Clinic, Azienda Ospedaliero Universitaria di Modena, Modena.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Cagnacci', 'Affiliation': 'Ginecologia e Ostetricia, Dipartimento di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno-Infantili, Università degli Studi di Genova, Ospedale Policlinico San Martino-IRCCS, Largo Benzi 3, Genova, Italy.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001626']
2508,32810088,Effect of oxytocin infusion on reducing blood loss during abdominal myomectomy: A randomized controlled trial.,"OBJECTIVE


To assess oxytocin infusion efficacy in terms of mean blood loss in patients undergoing abdominal myomectomy.
METHODS


The single-blind randomised control trial was conducted at the Obstetrics and Gynaecology Department of Military Hospital, Rawalpindi, Pakistan, July 15, 2017, to January 15, 2018, and comprised women with intramural fibroids of American Society of Anaesthesia class I and II who were candidates for elective abdominal myomectomy. The women were randomised into study and control groups. In the study group, an infusion of 30 units of oxytocin in 1000ml normal saline was given at the rate of 15 units/hour during surgery. In the control group, pure normal saline was given. The main outcome measure was intra-operative blood loss. Data was analysed using SPSS 21.
RESULTS


Of the 60 women, there were 30(50%) in the study group with a mean age of 37.10±4.35 years, and 30(50%) in the control group with a mean age of 36.67±3.70 (p>0.05). Mean intra-operative blood loss in the study group was 409.67±181.29ml which was significantly lower than the control group 875.33±284.71 (p<0.05). The mean surgery time also showed statistically significant difference between the two groups (p<0.05). In the study group, 3(10%) patients required blood transfusion, while blood was transfused to 11(36.6%) patients in the control group (p=0.046).
CONCLUSIONS


Oxytocin, when given as an infusion, was found to be effective in reducing blood loss during abdominal myomectomy.",2020,Mean intra-operative blood loss in the study group was 409.67±181.29ml which was significantly lower than the control group 875.33±284.71 (p<0.05).,"['Obstetrics and Gynaecology Department of Military Hospital, Rawalpindi, Pakistan, July 15, 2017, to January 15, 2018, and comprised women with intramural fibroids of American Society of Anaesthesia class', '60 women', 'abdominal myomectomy', 'patients undergoing abdominal myomectomy']","['oxytocin infusion', 'oxytocin', 'Oxytocin']","['Mean intra-operative blood loss', 'mean surgery time', 'intra-operative blood loss', 'blood transfusion', 'blood loss']","[{'cui': 'C0587480', 'cui_str': 'Obstetrics and gynecology department'}, {'cui': 'C0020012', 'cui_str': 'Military Hospitals'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0023267', 'cui_str': 'Leiomyofibroma'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0195309', 'cui_str': 'Uterine myomectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}]",,0.196277,Mean intra-operative blood loss in the study group was 409.67±181.29ml which was significantly lower than the control group 875.33±284.71 (p<0.05).,"[{'ForeName': 'Madiha', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'Department of Obstetrics and Gynecology, Military Hospital, Rawalpindi, Pakistan.'}, {'ForeName': 'Shehla', 'Initials': 'S', 'LastName': 'Baqai', 'Affiliation': 'Department of Obstetrics and Gynecology, Military Hospital, Rawalpindi, Pakistan.'}, {'ForeName': 'Arshad', 'Initials': 'A', 'LastName': 'Khushdil', 'Affiliation': 'Military Hospital, Rawalpindi (Army Medical Corps).'}, {'ForeName': 'Fariha', 'Initials': 'F', 'LastName': 'Ahmed', 'Affiliation': 'Department of Anesthesiology, Combined Military Hospital Rawalpindi, Pakistan.'}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.14026']
2509,32810089,Impact of intermittent kangaroo mother care on weight gain of neonate in nicu: Randomized control trial.,"OBJECTIVE


To measure the impact of intermittent kangaroo mother care on weight-gain of neonates in a neonatal intensive care unit.
METHODS


The randomised controlled trial was conducted at the Department of Neonatology, the Children Hospital and the Institute of Child Health, Lahore, Pakistan, from March to October, 2018, and recruited newborns admitted to the neonatal intensive care unit. The subjects were randomised into case and control groups. Intermittent kangaroo mother care was given in the case group for seven days. Data was collected and analysed using SPSS 23.
RESULTS


Of the 153 neonates, 140(91.5%) were included; 70(50%) in each group. The most common reason for admission was bronchopneumonia 49(35%). In the case group, average weight gain was 10.22±1.65 grams/kg/day compared to 7.87±1.71 in the control group (p=0.0001). The average length of stay in the case group was significantly low compared to the control group (p=0.003). Multivariate analysis determined the effect of kangaroo mother care therapy as effective (p<0.0001).
CONCLUSIONS


Intermittent kangaroo mother care was found to be effective for improving weight-gain in neonates in addition to the conventional treatment.",2020,The average length of stay in the case group was significantly low compared to the control group (p=0.003).,"['Of the 153 neonates, 140(91.5%) were included; 70(50%) in each group', 'neonate in nicu', 'Department of Neonatology, the Children Hospital and the Institute of Child Health, Lahore, Pakistan, from March to October, 2018, and recruited newborns admitted to the neonatal intensive care unit', 'neonates in a neonatal intensive care unit']","['intermittent kangaroo mother care', 'kangaroo mother care therapy']","['weight gain', 'average length of stay', 'average weight gain', 'weight-gain']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0027621', 'cui_str': 'Neonatology'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C1257803', 'cui_str': 'Kangaroo-Mother Care'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",,0.0492759,The average length of stay in the case group was significantly low compared to the control group (p=0.003).,"[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Obaid Ur Rehman', 'Affiliation': ""Department of Neonatology, The Children's Hospital and The Institute of Child Health Lahore, Pakistan.""}, {'ForeName': 'Sikandar', 'Initials': 'S', 'LastName': 'Hayat', 'Affiliation': ""Department of Neonatology, The Children's Hospital and The Institute of Child Health Lahore, Pakistan.""}, {'ForeName': 'Rafia', 'Initials': 'R', 'LastName': 'Gul', 'Affiliation': 'Fatima Memorial Hospital, Lahore, Pakistan.'}, {'ForeName': 'Khawaja Ahmad', 'Initials': 'KA', 'LastName': 'Irfan Waheed', 'Affiliation': ""Department of Neonatology, The Children's Hospital and The Institute of Child Health Lahore, Pakistan.""}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Victor', 'Affiliation': 'Islamabad Medical and Dental College, Islamabad, Pakistan.'}, {'ForeName': 'Mahzar Qadir', 'Initials': 'MQ', 'LastName': 'Khan', 'Affiliation': ""Department of Neonatology, The Children's Hospital and The Institute of Child Health Lahore, Pakistan.""}]",JPMA. The Journal of the Pakistan Medical Association,['10.5455/JPMA.45123']
2510,32810146,"Effectiveness of a culturally appropriate intervention to prevent intimate partner violence and HIV transmission among men, women, and couples in rural Ethiopia: Findings from a cluster-randomized controlled trial.","BACKGROUND


Intimate partner violence (IPV) is associated with increased HIV risk and other adverse health and psychosocial outcomes. We assessed the impact of Unite for a Better Life (UBL), a gender-transformative, participatory intervention delivered to men, women, and couples in Ethiopia in the context of the coffee ceremony, a traditional community-based discussion forum.
METHODS AND FINDINGS


Villages (n = 64) in 4 Ethiopian districts were randomly allocated to control, men's UBL, women's UBL, or couples' UBL, and approximately 106 households per village were randomly selected for inclusion in the trial. The intervention included 14 sessions delivered twice weekly by trained facilitators; control arm households were offered a short IPV educational session. Primary outcomes were women's experience of past-year physical or sexual IPV 24 months postintervention. Secondary outcomes included male perpetration of past-year physical or sexual IPV, comprehensive HIV knowledge, and condom use at last intercourse. Additional prespecified outcomes included experience and perpetration of past-year physical and/or sexual IPV and emotional IPV, HIV/AIDs knowledge and behaviors, decision-making, and gender norms. An intention-to-treat (ITT) analysis was conducted, evaluating 6,770 households surveyed at baseline in 2014-2015 (1,680 households, 16 clusters in control; 1,692 households, 16 clusters in couples' UBL; 1,707 households, 16 clusters in women's UBL; 1,691 households, 16 clusters in men's UBL). Follow-up data were available from 88% of baseline respondents and 87% of baseline spouses surveyed in 2017-2018. Results from both unadjusted and adjusted specifications are reported, the latter adjusting for age, education level, marriage length, polygamy, socioeconomic status, and months between intervention and endline. For primary outcomes, there was no effect of any UBL intervention compared to control on women's past-year experience of physical (couples' UBL arm adjusted odds ratio [AOR] = 1.00, 95% confidence interval [CI]: 0.77-1.30, p = 0.973; women's UBL arm AOR = 1.11, 95% CI 0.87-1.42, p = 0.414; men's UBL arm AOR = 1.02, 95% CI: 0.81-1.28, p = 0.865) or sexual IPV (couples' UBL arm AOR = 0.86, 95% CI: 0.62-1.20, p = 0.378; women's UBL arm AOR = 1.15, 95% CI: 0.89-1.50; p = 0.291; men's UBL arm AOR = 0.80, 95% CI: 0.63-1.01, p = 0.062). For the secondary outcomes, only the men's UBL intervention significantly reduced male perpetration of past-year sexual IPV (AOR: 0.73; 95% CI: 0.56-0.94, p = 0.014), and no intervention reduced perpetration of past-year physical IPV. Among women, the couples' UBL intervention significantly improved comprehensive HIV knowledge, and both couples' and women's UBL significantly increased reported condom use at last intercourse. Among additional outcomes of interest, the men's UBL intervention was associated with a significant reduction in women's experience of past-year physical and/or sexual IPV (AOR = 0.81, 95% CI: 0.66-0.99, p = 0.036) and men's perpetration of physical and/or sexual IPV (AOR = 0.78; 95% CI: 0.62-0.98, p = 0.037). UBL delivered to men and couples was associated with a significant reduction in HIV risk behaviors and more equitable intrahousehold decision-making and household task-sharing. The primary limitation is reliance on self-reported data.
CONCLUSIONS


A gender-transformative intervention delivered to men was effective in reducing self-reported perpetration of sexual IPV but did not reduce IPV when delivered to couples or women. We found evidence of decreased sexual IPV with men's UBL across men's and women's reports and of increased HIV knowledge and condom use at last intercourse among women. The men's UBL intervention could help accelerate progress towards gender equality and combating HIV/AIDS.
TRIAL REGISTRATION


The trial was prospectively registered at clinicaltrials.gov (NCT02311699) and in the American Economic Association registry (AEARCTR-0000211).",2020,"CONCLUSIONS


A gender-transformative intervention delivered to men was effective in reducing self-reported perpetration of sexual IPV but did not reduce IPV when delivered to couples or women.","[""6,770 households surveyed at baseline in 2014-2015 (1,680 households, 16 clusters in control; 1,692 households, 16 clusters in couples' UBL; 1,707 households, 16 clusters in women's UBL; 1,691 households, 16 clusters in men's UBL"", 'men, women, and couples in Ethiopia in the context of the coffee ceremony, a traditional community-based discussion forum', 'Intimate partner violence (IPV', 'men, women, and couples in rural Ethiopia', ""Villages (n = 64) in 4 Ethiopian districts were randomly allocated to control, men's UBL, women's UBL, or couples' UBL, and approximately 106 households per village""]","['culturally appropriate intervention', 'UBL', '14 sessions delivered twice weekly by trained facilitators; control arm households were offered a short IPV educational session', 'UBL intervention']","[""women's experience of past-year physical or sexual IPV 24 months postintervention"", 'sexual IPV', 'male perpetration of past-year sexual IPV', ""women's experience of past-year physical and/or sexual IPV"", 'intimate partner violence and HIV transmission', ""comprehensive HIV knowledge, and both couples' and women's UBL"", 'experience and perpetration of past-year physical and/or sexual IPV and emotional IPV, HIV/AIDs knowledge and behaviors, decision-making, and gender norms', 'HIV risk behaviors', ""women's past-year experience of physical"", ""men's perpetration of physical and/or sexual IPV"", 'male perpetration of past-year physical or sexual IPV, comprehensive HIV knowledge, and condom use at last intercourse']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0015024', 'cui_str': 'Ethiopia'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0166872', 'cui_str': 'Unite resin'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",6770.0,0.220406,"CONCLUSIONS


A gender-transformative intervention delivered to men was effective in reducing self-reported perpetration of sexual IPV but did not reduce IPV when delivered to couples or women.","[{'ForeName': 'Vandana', 'Initials': 'V', 'LastName': 'Sharma', 'Affiliation': 'Abdul Latif Jameel Poverty Action Lab, Massachusetts Institute of Technology, Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Leight', 'Affiliation': 'International Food Policy Research Institute, Washington, DC, United States of America.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Verani', 'Affiliation': 'CARE, New York, United States of America.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Tewolde', 'Affiliation': 'EngenderHealth, Addis Ababa, Ethiopia.'}, {'ForeName': 'Negussie', 'Initials': 'N', 'LastName': 'Deyessa', 'Affiliation': 'Ethiopian Public Health Association, Addis Ababa, Ethiopia.'}]",PLoS medicine,['10.1371/journal.pmed.1003274']
2511,29866212,Factors associated with poor satisfaction with treatment and trial discontinuation in chronic schizophrenia.,"IntroductionDespite consistently high discontinuation rates due to withdrawal of consent (WOC) and insufficient therapeutic effect (ITE) in schizophrenia trials, insight into the underlying factors contributing to poor satisfaction with treatment and dropout is limited. A better understanding of these factors could help to improve trial design and completion rates.
METHODS


Using data from 1,136 trial participants with schizophrenia or schizoaffective disorder, we explored associations between predictor variables with (1) dropout due to WOC and ITE and (2) satisfaction with treatment among patients and investigators by means of hierarchic multiple regression analyses.
RESULTS


ITE was associated with poor clinical improvement, poor investigator satisfaction with treatment, and poor patient insight into their own disease, whereas WOC only showed a meaningful association with poor patient satisfaction with treatment. Investigator satisfaction with treatment appeared most strongly associated with Positive and Negative Syndrome Scale (PANSS) positive factor endpoint scores, whereas patient satisfaction with treatment was best predicted by the endpoint score on the PANSS emotional distress factor. The occurrence of severe side effects showed no meaningful association to satisfaction with treatment among investigators and patients, and neither did a patient's experienced psychopathology, nor their self-rating of functional impairment.
CONCLUSIONS


Whereas trial discontinuation due to ITE is associated with poor treatment effectiveness, a patient's decision to withdraw from an antipsychotic trial remains unpredictable and may occur even when the investigator observes a global clinical improvement and is satisfied with the treatment.",2019,"Investigator satisfaction with treatment appeared most strongly associated with Positive and Negative Syndrome Scale (PANSS) positive factor endpoint scores, whereas patient satisfaction with treatment was best predicted by the endpoint score on the PANSS emotional distress factor.","['Using data from 1,136 trial participants with schizophrenia or schizoaffective disorder', 'chronic schizophrenia']",[],"['predictor variables with (1) dropout due to WOC and ITE and (2) satisfaction', 'Investigator satisfaction', 'Positive and Negative Syndrome Scale (PANSS) positive factor endpoint scores']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C0221765', 'cui_str': 'Chronic schizophrenia'}]",[],"[{'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0155414,"Investigator satisfaction with treatment appeared most strongly associated with Positive and Negative Syndrome Scale (PANSS) positive factor endpoint scores, whereas patient satisfaction with treatment was best predicted by the endpoint score on the PANSS emotional distress factor.","[{'ForeName': 'Joep H', 'Initials': 'JH', 'LastName': 'Schoemaker', 'Affiliation': 'Department of Medical and Clinical Psychology,Tilburg University,Tilburg,The Netherlands.'}, {'ForeName': 'Ad J J M', 'Initials': 'AJJM', 'LastName': 'Vingerhoets', 'Affiliation': 'Department of Medical and Clinical Psychology,Tilburg University,Tilburg,The Netherlands.'}, {'ForeName': 'Robin A', 'Initials': 'RA', 'LastName': 'Emsley', 'Affiliation': 'Faculty of Medicine and Health Sciences,Stellenbosch University,Cape Town,Republic of South Africa.'}]",CNS spectrums,['10.1017/S109285291700044X']
2512,30151631,Improved Expectations About Length of Sick Leave During Occupational Rehabilitation Is Associated with Increased Work Participation.,"Objectives To assess changes in participants' expectations about length of sick leave during Acceptance and Commitment Therapy (ACT)-based occupational rehabilitation, and whether the change in expectations was associated with future work participation. Methods Cohort study with 9 months follow-up including sick listed workers who took part in one of two randomized controlled trials. The change in expectations about length of sick leave were assessed using a test of marginal homogeneity. Furthermore, linear and logistic regression evaluated associations between changes in expectations and sustainable return to work (RTW) and work participation days. Results During rehabilitation, there was a statistically significant improvement in participants' (n = 168) expectations about length of sick leave. During 9 months follow-up, participants with consistently positive expectations had the highest probability of RTW (0.81, 95% CI 0.67-0.95) and the most work participation days (159, 95% CI 139-180). Participants with improved expectations had higher probability of sustainable RTW (0.68, 95% CI 0.50-0.87) and more work participation days (133, 95% CI 110-156) compared to those with reduced (probability of RTW: 0.50, 95% CI 0.22-0.77; workdays: 116, 95% CI 85-148), or consistently negative expectations (probability of RTW: 0.23, 95% CI 0.15-0.31; workdays: 93, 95% CI 82-103). Conclusions During ACT-based occupational rehabilitation, 33% improved, 48% remained unaltered, and 19% of the participants reduced their expectations about RTW. Expectations about RTW can be useful to evaluate in the clinic, and as an intermediary outcome in clinical trials. The changes were associated with future work outcomes, suggesting that RTW expectations is a strong predictor for RTW.",2019,"During rehabilitation, there was a statistically significant improvement in participants' (n = 168) expectations about length of sick leave.",['sick listed workers who took part in one of two randomized controlled trials'],['Occupational Rehabilitation'],"['probability of sustainable RTW', 'highest probability of RTW', 'expectations and sustainable return to work (RTW) and work participation days', 'expectations about length of sick leave', 'Sick Leave']","[{'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}]",,0.28098,"During rehabilitation, there was a statistically significant improvement in participants' (n = 168) expectations about length of sick leave.","[{'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Aasdahl', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Postboks 8905, MTFS, 7491, Trondheim, Norway. lene.aasdahl@ntnu.no.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Pape', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Postboks 8905, MTFS, 7491, Trondheim, Norway.'}, {'ForeName': 'Ottar', 'Initials': 'O', 'LastName': 'Vasseljen', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Postboks 8905, MTFS, 7491, Trondheim, Norway.'}, {'ForeName': 'Roar', 'Initials': 'R', 'LastName': 'Johnsen', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Postboks 8905, MTFS, 7491, Trondheim, Norway.'}, {'ForeName': 'Marius Steiro', 'Initials': 'MS', 'LastName': 'Fimland', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Postboks 8905, MTFS, 7491, Trondheim, Norway.'}]",Journal of occupational rehabilitation,['10.1007/s10926-018-9808-4']
2513,31033190,Genomic Association Analysis Reveals Variants Associated With Blood Pressure Response to Beta-Blockers in European Americans.,"European Americans (EA) have a better antihypertensive response to β-blockers when compared with African Americans, albeit with some variability. We undertook a genomewide association study to elucidate the underlying genetic determinants in EA contributing to this variability in blood pressure (BP) response. A discovery genomewide association study of change in BP post-metoprolol treatment was performed in EA participants (n = 201) from the Pharmacogenomic Evaluation of Antihypertensive Responses-2 (PEAR-2) study and tested for replication in the atenolol-treated EA from the PEAR study (n = 233). Rs294610 in the FGD5, which encodes for FYVE, RhoGEF and PH Domain Containing 5, (expression quantitative trait loci for FGD5 in the small intestine) was significantly associated with increased diastolic BP response to β-blockers in the PEAR-2 study (P = 3.41 × 10 -6  , β = -2.70) and replicated (P = 0.01, β = -1.17) in the PEAR study. Post-meta-analysis of these studies, an additional single nucleotide polymorphism rs45545233 in the SLC4A1, encoding for Solute Carrier Family 4 Member 1, (expression quantitative trait loci for dual specificity phosphatase 3 in the artery tibial) was identified that was significantly associated with a poor response to β-blockers (P = 3.43 × 10 -6  , β = 4.57) and was replicated in the atenolol add-on cohort (P = 0.007, β = 4.97). We identified variants in FGD5 and SLC4A1, which have been previously cited as candidate genes for hypertension, to be associated with a β-blocker BP response in EA. Further elucidation is warranted of the underlying mechanisms of these variants and genes by which they influence the BP response to β-blockers.",2019,"We identified variants in FGD5 and SLC4A1, which have been previously cited as candidate genes for hypertension, to be associated with a β-blocker BP response in EA.","['European Americans (EA', 'European Americans', 'EA participants (n\xa0=\xa0201) from the Pharmacogenomic Evaluation of Antihypertensive Responses-2 (PEAR-2) study and tested for replication in the atenolol-treated EA from the PEAR study (n\xa0=\xa0233']",['metoprolol'],"['diastolic BP response', 'Blood Pressure Response', 'blood pressure (BP) response']","[{'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C1138555', 'cui_str': 'Pharmacogenomic specialist'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0598312', 'cui_str': 'DNA replication'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0330664', 'cui_str': 'Pyrus communis'}]","[{'cui': 'C0025859', 'cui_str': 'Metoprolol'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",,0.0324593,"We identified variants in FGD5 and SLC4A1, which have been previously cited as candidate genes for hypertension, to be associated with a β-blocker BP response in EA.","[{'ForeName': 'Sonal', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Nihal', 'Initials': 'N', 'LastName': 'El Rouby', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Caitrin W', 'Initials': 'CW', 'LastName': 'McDonough', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Kent R', 'Initials': 'KR', 'LastName': 'Bailey', 'Affiliation': 'Department of Health Sciences Research, Division of Biostatistics, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Boerwinkle', 'Affiliation': 'Human Genetics and Institute of Molecular Medicine, University of Texas Health Science Center, Houston, Texas, USA.'}, {'ForeName': 'Arlene B', 'Initials': 'AB', 'LastName': 'Chapman', 'Affiliation': 'Division of Nephrology, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Gums', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Turner', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Rhonda M', 'Initials': 'RM', 'LastName': 'Cooper-DeHoff', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Johnson', 'Affiliation': 'Department of Pharmacotherapy and Translational Research and Center for Pharmacogenomics, University of Florida, Gainesville, Florida, USA.'}]",Clinical and translational science,['10.1111/cts.12643']
2514,31257614,"Pharmacokinetics of Risankizumab in Asian Healthy Subjects and Patients With Moderate to Severe Plaque Psoriasis, Generalized Pustular Psoriasis, and Erythrodermic Psoriasis.","Risankizumab, a humanized monoclonal antibody that targets interleukin-23 p19 subunit, was developed for the treatment of psoriasis. This work characterizes risankizumab pharmacokinetics in Japanese and Chinese healthy subjects compared with white healthy subjects and in Japanese patients with moderate to severe plaque psoriasis, generalized pustular psoriasis, or erythrodermic psoriasis. A phase 1, single-dose study evaluated risankizumab pharmacokinetics and safety/tolerability in healthy white (18 and 300 mg subcutaneous [SC]), Japanese (18, 90, and 300 mg SC and 200, 600, and 1200 mg intravenous [IV]), and Chinese (18, 90, and 300 mg SC) subjects; pharmacokinetic data were analyzed using noncompartmental methods. Risankizumab pharmacokinetic data from phase 2/3 studies in Japanese patients with plaque psoriasis, generalized pustular psoriasis, or erythrodermic psoriasis following multiple SC doses of 75 mg or 150 mg were analyzed using a population pharmacokinetic approach along with data from the phase 1 and global phase 1 to 3 studies. Risankizumab plasma exposures (peak plasma concentration and area under the concentration-time curve) were approximately dose-proportional across 18- to 300-mg SC or 200- to 1200-mg IV doses. Risankizumab terminal elimination half-life (harmonic mean 27-34 days) was comparable across doses and ethnicities. Risankizumab exposures were approximately 20% to 30% higher in Japanese and Chinese healthy subjects compared with white healthy subjects or in Japanese patients compared with non-Japanese patients. After accounting for body-weight differences, risankizumab exposures were comparable across ethnicities. Overall, there was no ethnic impact on risankizumab pharmacokinetics, and the small difference in exposure due to body weight has no clinical relevance.",2019,Risankizumab exposures were approximately 20% to 30% higher in Japanese and Chinese healthy subjects compared with white healthy subjects or in Japanese patients compared with non-Japanese patients.,"['Japanese patients with plaque psoriasis, generalized pustular psoriasis, or erythrodermic psoriasis', 'Japanese and Chinese healthy subjects compared with white healthy subjects and in Japanese patients with moderate to severe plaque psoriasis, generalized pustular psoriasis, or erythrodermic psoriasis', 'healthy white (18 and 300\xa0mg', 'Asian Healthy Subjects and Patients With Moderate to Severe Plaque Psoriasis, Generalized Pustular Psoriasis, and Erythrodermic Psoriasis']","['subcutaneous [SC', 'Risankizumab']","['risankizumab pharmacokinetics and safety/tolerability', 'Risankizumab plasma exposures (peak plasma concentration and area under the concentration-time curve']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0343055', 'cui_str': 'Generalized pustular psoriasis'}, {'cui': 'C0748052', 'cui_str': 'Erythrodermic psoriasis'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4505511', 'cui_str': 'risankizumab'}]","[{'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",,0.0273464,Risankizumab exposures were approximately 20% to 30% higher in Japanese and Chinese healthy subjects compared with white healthy subjects or in Japanese patients compared with non-Japanese patients.,"[{'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Khatri', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Doerthe', 'Initials': 'D', 'LastName': 'Eckert', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co KG, Ludwigshafen am Rhein, Germany.'}, {'ForeName': 'Rajneet', 'Initials': 'R', 'LastName': 'Oberoi', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Suleiman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Deutschland GmbH & Co KG, Ludwigshafen am Rhein, Germany.'}, {'ForeName': 'Yinuo', 'Initials': 'Y', 'LastName': 'Pang', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, IL, USA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Cheng', 'Affiliation': 'Discovery and Exploratory Statistics, AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., North Chicago, IL, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1473']
2515,31390595,"Association of basal metabolic rate and fuel oxidation in basal conditions and during exercise, with plasma S-klotho: the FIT-AGEING study.","S-klotho, the shed form of α-klotho, is thought to be an ageing suppressor with functions related to the physiology of energy metabolism. However, it remains unknown whether ageing biomarkers such as S-klotho and/or chronological ageing are associated in any way with basal metabolic rate (BMR) and fuel oxidation in basal conditions and during exercise. The present work investigates the association of BMR and fuel oxidation in basal conditions and during exercise, with plasma S-klotho in middle-aged, sedentary adults. BMR was measured by indirect calorimetry in 74 such subjects (53% women; age 53.7±5.1 years) following standard procedures, and their fuel oxidation estimated via stoichiometric equations. The maximal fat oxidation during exercise (MFO) and the intensity of exercise that elicits MFO (Fat max ) were determined using a walking graded exercise test. No relationship was seen between BMR and plasma S-klotho (P>0.1), although both basal fat oxidation and MFO showed positive associations with this protein (both P<0.001); these relationships persisted after controlling for age, sex and fat mass. However, no significant associations were seen between BMR, basal fat oxidation or MFO and chronological age (all P>0.1). The present findings suggest that basal fat oxidation and MFO are strongly associated with plasma S-klotho in middle-aged sedentary adults. These results support the idea that metabolic flexibility is a powerful predictor of biological ageing.",2019,"No relationship was seen between BMR and plasma S-klotho (P>0.1), although both basal fat oxidation and MFO showed positive associations with this protein (both P<0.001); these relationships persisted after controlling for age, sex and fat mass.","['middle-aged sedentary adults', 'middle-aged, sedentary adults']",[],"['BMR and plasma S-klotho (P>0.1', 'maximal fat oxidation during exercise (MFO) and the intensity of exercise that elicits MFO (Fat max ', 'BMR', 'BMR, basal fat oxidation or MFO and chronological age']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0542499', 'cui_str': 'Measurement of basal metabolic rate'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1144173', 'cui_str': 'KL protein, human'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",,0.0173147,"No relationship was seen between BMR and plasma S-klotho (P>0.1), although both basal fat oxidation and MFO showed positive associations with this protein (both P<0.001); these relationships persisted after controlling for age, sex and fat mass.","[{'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Amaro-Gahete', 'Affiliation': 'EFFECTS-262 Research Group, Department of Medical Physiology, School of Medicine, University of Granada, Granada, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'De-la-O', 'Affiliation': 'EFFECTS-262 Research Group, Department of Medical Physiology, School of Medicine, University of Granada, Granada, Spain.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Jurado-Fasoli', 'Affiliation': 'EFFECTS-262 Research Group, Department of Medical Physiology, School of Medicine, University of Granada, Granada, Spain.'}, {'ForeName': 'Jonatan R', 'Initials': 'JR', 'LastName': 'Ruiz', 'Affiliation': 'PROmoting FITness and Health through Physical Activity Research Group (PROFITH), Sport and Health University Research Institute (iMUDS), Department of Physical Education and Sports, Faculty of Sport Sciences, University of Granada, Granada, Spain.'}, {'ForeName': 'Manuel J', 'Initials': 'MJ', 'LastName': 'Castillo', 'Affiliation': 'EFFECTS-262 Research Group, Department of Medical Physiology, School of Medicine, University of Granada, Granada, Spain.'}]",Aging,['10.18632/aging.102100']
2516,32813632,"Physical activity and perceived benefits, but not barriers, to exercise differ by sex and school year among college students.","OBJECTIVE


To assess whether sex or school year influence physical activity and exercise (PA/EX) behaviors and perceived benefits and barriers of PA/EX among college students.  Participants:  Participants were 862 (78% female; 20.1 ± 1.4 years) college students.  Methods:  The International Physical Activity Questionnaire, Exercise Benefits and Barriers Scale, and resistance training (RT) questions were completed online.  Results:  Factorial ANOVA (sex x year) determined no significant interaction effects of sex and school year in behaviors or perceived benefits and barriers (all  p  > .05). Males reported higher levels of PA/EX and RT than females ( p  < .05) with no differences by school year ( p  = .34). Benefits Scale scores and some of its subscales were higher for males and first-year students compared to females and third- and fourth-year students (all  p  < .05).  Conclusion:  PA/EX promotion programs may need to be tailored differently based on sex and school year.",2020,Males reported higher levels of PA/EX and RT than females ( p  < .05) with no differences by school year ( p  = .34).,"['Participants', 'Participants were 862 (78% female; 20.1\u2009±\u20091.4\u2009years) college students', 'college students']",['sex or school year influence physical activity and exercise (PA/EX) behaviors'],"['Physical activity and perceived benefits', 'International Physical Activity Questionnaire, Exercise Benefits and Barriers Scale, and resistance training', 'sex and school year in behaviors or perceived benefits and barriers ', 'levels of PA/EX and RT']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0206412,Males reported higher levels of PA/EX and RT than females ( p  < .05) with no differences by school year ( p  = .34).,"[{'ForeName': 'Ginny M', 'Initials': 'GM', 'LastName': 'Frederick', 'Affiliation': 'Department of Kinesiology, University of Georgia, Athens, Georgia, USA.'}, {'ForeName': 'Ewan R', 'Initials': 'ER', 'LastName': 'Williams', 'Affiliation': 'Department of Kinesiology, University of Georgia, Athens, Georgia, USA.'}, {'ForeName': 'Isaura M', 'Initials': 'IM', 'LastName': 'Castillo-Hernández', 'Affiliation': 'Department of Kinesiology, University of Georgia, Athens, Georgia, USA.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Evans', 'Affiliation': 'Department of Kinesiology, University of Georgia, Athens, Georgia, USA.'}]",Journal of American college health : J of ACH,['10.1080/07448481.2020.1800711']
2517,32813780,Learning musculoskeletal anatomy through new technologies: a randomized clinical trial.,"OBJECTIVE


to investigate the influence of the application of new methodologies on learning and the motivation of students of the Anatomy discipline.
METHOD


randomized, longitudinal, prospective, intervention study. Sixty-two students were recruited to assess the impact of different methodologies. The sample was randomized to compare the results of teaching with a 3D atlas, ultrasound and the traditional method. The parameters were assessed through a satisfaction evaluation questionnaire and anatomical charts. Repeated measures ANOVA was used to determine statistical significance.
RESULTS


in terms of the usefulness of the seminars, 98.1% of the students considered them to be very positive or positive, stating that they had stimulated their interest in anatomy. The students who learned with the 3D atlas improved their understanding of anatomy (p=0.040). In general, the students improved their grades by around 20%.
CONCLUSION


the traditional method combined with new technologies increases the interest of students in human anatomy and enables them to acquire skills and competencies during the learning process.",2020,The students who learned with the 3D atlas improved their understanding of anatomy (p=0.040).,['Sixty-two students'],[],[],"[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],[],62.0,0.0349984,The students who learned with the 3D atlas improved their understanding of anatomy (p=0.040).,"[{'ForeName': 'Elena Sonsoles', 'Initials': 'ES', 'LastName': 'Rodríguez-López', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Sofía Olivia', 'Initials': 'SO', 'LastName': 'Calvo-Moreno', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Eduardo Cimadevilla', 'Initials': 'EC', 'LastName': 'Fernández-Pola', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Fernández-Rodríguez', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Guodemar-Pérez', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Ruiz-López', 'Affiliation': 'Camilo José Cela University, Madrid, Spain.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3237.3281']
2518,32813829,Cost-effectiveness of Drug-Eluting Stents in Percutaneous Coronary Intervention in Brazil's Unified Public Health System (SUS).,"Background The use of drug-eluting stents (DESs), compared with bare-metal stents (BMSs), in percutaneous coronary intervention (PCI) has reduced the rate of restenosis, without an impact on mortality but with an increase in costs. Medical literature lacks randomized studies that economically compare these 2 stent types within the reality of the Brazilian Unified Public Health System (SUS). Objective To estimate the incremental cost-effectiveness ratio (ICER) between DES and BMS in SUS patients with single-vessel coronary artery disease. Methods Over a 3-year period, patients with symptomatic single-vessel coronary artery disease were randomized in a 1:2 ratio to receive a DES or BMS during PCI, with a 1-year clinical follow-up. The evaluation included in-stent restenosis (ISR), target lesion revascularization (TLR), major adverse events, and cost-effectiveness for each group. P-values <0.05 were considered significant. Results In the DES group, of 74 patients (96.1%) who completed the follow-up, 1 developed ISR (1.4%), 1 had TLR (1.4%), and 1 died (1.4%), with no cases of thrombosis. In the BMS group, of 141 patients (91.5%), ISR occurred in 14 (10.1%), TLR in 10 (7.3%), death in 3 (2.1%), and thrombosis in 1 (0.74%). In the economic analysis, the cost of the procedure was R$ 5,722.21 in the DES group and R$ 4,085.21 in the BMS group. The effectiveness by ISR and TLR was 8.7% for DES and 5.9% for BMS, with an ICER of R$ 18,816.09 and R$ 27,745.76, respectively. Conclusions In the SUS, DESs were cost-effective in accordance with the cost-effectiveness threshold recommended by the World Health Organization (Arq Bras Cardiol. 2020; 115(1):80-89).",2020,"In the SUS, DESs were cost-effective in accordance with the cost-effectiveness threshold recommended by the World Health Organization (Arq Bras Cardiol.","['patients with symptomatic single-vessel coronary artery disease', 'SUS patients with single-vessel coronary artery disease']","['DES or BMS', 'percutaneous coronary intervention (PCI', 'drug-eluting stents (DESs), compared with bare-metal stents (BMSs', 'Drug-Eluting Stents']","['death', 'TLR', 'stent restenosis (ISR), target lesion revascularization (TLR), major adverse events, and cost-effectiveness', 'ISR', 'incremental cost-effectiveness ratio (ICER', 'cost of the procedure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0581374', 'cui_str': 'Single coronary vessel disease'}, {'cui': 'C0574518', 'cui_str': 'Susu language'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C2825200', 'cui_str': 'Bare metal stent'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C3272317', 'cui_str': 'Stent restenosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",,0.0721266,"In the SUS, DESs were cost-effective in accordance with the cost-effectiveness threshold recommended by the World Health Organization (Arq Bras Cardiol.","[{'ForeName': 'João Addison', 'Initials': 'JA', 'LastName': 'Pessoa', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Esmeralci', 'Initials': 'E', 'LastName': 'Ferreira', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Denizar Viana', 'Initials': 'DV', 'LastName': 'Araújo', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Edirley', 'Initials': 'E', 'LastName': 'Maia', 'Affiliation': 'Hospital São Lucas, Nova Friburgo, RJ, Brasil.'}, {'ForeName': 'Felipe Souza Maia da', 'Initials': 'FSMD', 'LastName': 'Silva', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Maurício Salles de', 'Initials': 'MS', 'LastName': 'Oliveira', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.'}, {'ForeName': 'Denilson Campos de', 'Initials': 'DC', 'LastName': 'Albuquerque', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.'}]",Arquivos brasileiros de cardiologia,['10.36660/abc.20180292']
2519,32809966,"Comparative study regarding effect of pH on Misoprostol in induction of labor in full term primigravida pregnant women, a double blind randomized controlled trial.","Objectives To evaluate the effect of altering vaginal pH on induction of labor in full-term pregnancies using Misoprostol. Methods This randomized controlled trial was conducted at Kasralainy Hospital, Cairo University, Egypt and Algezeera Hospital, Egypt. A total of 218 healthy term primigravida pregnant women who were scheduled for pregnancy termination were recruited in the study. The included patients were divided into three groups; Group A: Those who received normal saline vaginal wash (0.9% NaCl), Group B: those who received alkaline vaginal wash (5% sodium bicarbonate) and Group C: those who received acidic vaginal wash (5% acetic acid). Patients received 25 μg of Misoprostol E1 (Vagiprost® Adwia Pharmaceuticals, Egypt) every 6 h for a maximum of 24 h (total of four potential doses). Results The 'acid' group participants took a mean time of 20.46 h to reach active stage of labor, followed by the 'normal saline' group with 21.45 h and the 'alkaline' group with 22.59 h. The difference between the groups was statistically significant, with a p-value of 0.013. Conclusions Douching the vagina with acidic solution seems to supplement the effect of Misoprostol on inducing labor in full-term pregnancies, as evidenced by having the shortest mean time needed to reach active stage of labor.",2020,"The difference between the groups was statistically significant, with a p-value of 0.013.","['full term primigravida pregnant women', 'Kasralainy Hospital, Cairo University, Egypt and Algezeera Hospital, Egypt', '218 healthy term primigravida pregnant women who were scheduled for pregnancy termination were recruited in the study']","['alkaline vaginal wash (5% sodium bicarbonate', 'Misoprostol', 'normal saline vaginal wash (0.9% NaCl', 'acidic vaginal wash (5% acetic acid', 'vaginal pH', 'Misoprostol E1', 'pH']",['mean time of 20.46\xa0h to reach active stage of labor'],"[{'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0860096', 'cui_str': 'Primigravida'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0392535', 'cui_str': 'Termination of pregnancy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C1547959', 'cui_str': 'Wash'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0085174', 'cui_str': 'Misoprostol'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022864', 'cui_str': 'Labor'}]",218.0,0.243436,"The difference between the groups was statistically significant, with a p-value of 0.013.","[{'ForeName': 'Ahmed S S A', 'Initials': 'ASSA', 'LastName': 'Rashwan', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Alalfy', 'Affiliation': 'Reproductive Health and Family Planning Department, National Research Centre, Aljazeerah Hospital, Giza, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El-Sharkawy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Abdelfatah', 'Initials': 'A', 'LastName': 'Eldesouky', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed Sa', 'Initials': 'AS', 'LastName': 'Ashour', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Alebrashy', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Bakry', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Cairo University, Cairo, Egypt.'}]",Journal of perinatal medicine,['10.1515/jpm-2020-0212']
2520,32810030,Fasting Ghrelin and Postprandial GLP-1 Levels in Patients With Morbid Obesity and Medical Comorbidities After Sleeve Gastrectomy and One-anastomosis Gastric Bypass: A Randomized Clinical Trial.,"BACKGROUND


Sleeve gastrectomy (SG) and one-anastomosis gastric bypass (OAGB) are among the commonly performed bariatric procedures. This randomized study aimed to compare SG and OAGB in terms of weight loss, improvement in comorbidities, and change in serum ghrelin and glucagon-like peptide-1 (GLP-1) levels.
PATIENTS AND METHODS


This was a prospective randomized trial on patients with morbid obesity associated with medical comorbidities who were randomly assigned to 1 of 2 equal groups; group I underwent SG and group II underwent OAGB. Outcome measures were percent of excess weight loss (%EWL), improvement in comorbidities, change in the venous levels of fasting ghrelin and postprandial GLP-1 at 12 months after surgery, in addition to operation time and complications.
RESULTS


Forty patients (38 female) of a mean age of 33.8 years and mean body mass index of 48.6 kg/m were included. Operation time in group II was significantly longer than in group I (86 vs. 52.87 min; P<0.001). There were 6 recorded complications (1 in group I and 5 in group II, P=0.18). The %EWL, %total weight loss, and %excess body mass index loss at 6 and 12 months postoperatively were significantly higher in group II than in group I. Both groups had similar rates of improvement in comorbidities. Group I had significantly lower ghrelin and GLP-1 levels postoperatively at 6 and 12 months, respectively, as compared with group II.
CONCLUSIONS


OAGB was associated with significantly higher EWL than SG. The reduction in fasting ghrelin and postprandial GLP-1 serum levels at 12 months after SG was significantly higher than that after OAGB.",2020,The reduction in fasting ghrelin and postprandial GLP-1 serum levels at 12 months after SG was significantly higher than that after OAGB.,"['patients with morbid obesity associated with medical comorbidities', 'Forty patients (38 female) of a mean age of 33.8 years and mean body mass index of 48.6\u2009kg/m were included', 'Patients With Morbid Obesity and Medical Comorbidities']","['Sleeve Gastrectomy and One-anastomosis Gastric Bypass', 'SG and OAGB', 'SG and group II underwent OAGB', 'Sleeve gastrectomy (SG) and one-anastomosis gastric bypass (OAGB']","['operation time and complications', 'Fasting Ghrelin and Postprandial GLP-1 Levels', 'excess weight loss (%EWL), improvement in comorbidities, change in the venous levels of fasting ghrelin and postprandial GLP-1', 'fasting ghrelin and postprandial GLP-1 serum levels', 'ghrelin and GLP-1 levels', 'complications', 'total weight loss, and %excess body mass index loss', 'Operation time', 'comorbidities', 'weight loss, improvement in comorbidities, and change in serum ghrelin and glucagon-like peptide-1 (GLP-1) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028756', 'cui_str': 'Morbid obesity'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.0482726,The reduction in fasting ghrelin and postprandial GLP-1 serum levels at 12 months after SG was significantly higher than that after OAGB.,"[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Roushdy', 'Affiliation': 'General Surgery Department, Mansoura University Hospitals, Mansoura University, Mansoura City, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Abdel-Razik', 'Affiliation': ''}, {'ForeName': 'Sameh H', 'Initials': 'SH', 'LastName': 'Emile', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Farid', 'Affiliation': ''}, {'ForeName': 'Hosam G', 'Initials': 'HG', 'LastName': 'Elbanna', 'Affiliation': ''}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Khafagy', 'Affiliation': ''}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Elshobaky', 'Affiliation': ''}]","Surgical laparoscopy, endoscopy & percutaneous techniques",['10.1097/SLE.0000000000000844']
2521,32810055,"Effects of Teaching Evidence-Based Medicine on Physician Assistant Students' Critical Appraisal, Self-Efficacy, and Clinical Application: A Randomized Controlled Trial.","PURPOSE


To use a randomized controlled design to explore the effects of evidence-based medicine (EBM) education on physician assistant (PA) students' EBM knowledge, self-efficacy, and evidence-seeking behavior in a simulated clinical situation and to present a model of EBM competence.
METHODS


Sixty-one didactic-year PA students from one Midwestern University (2 sequential cohorts) were randomized to receive the standard PA curriculum plus EBM training (intervention) or the standard PA curriculum only (control). Evidence-based medicine knowledge was measured with a validated Fresno test. Self-efficacy was measured with a validated Likert scale. Clinical application of EBM skills was measured with an objective structured clinical examination (OSCE).
RESULTS


Evidence-based medicine education led to significant improvements on the Fresno and self-efficacy tests, both within and between groups. On the OSCE, the intervention group performed no better than the control group. Higher Fresno pretest scores were significantly related to decreasing improvements in the posttest scores: R = -0.634.
CONCLUSION


Teaching EBM to PA students improved their EBM knowledge and self-efficacy but not their clinical application. Future research should focus on enhancing EBM evaluation and application in the clinical setting.",2020,Higher Fresno pretest scores were significantly related to decreasing improvements in the posttest scores:,['Sixty-one didactic-year PA students from one Midwestern University (2 sequential cohorts'],"['Teaching Evidence-Based Medicine', 'standard PA curriculum plus EBM training (intervention) or the standard PA curriculum only (control', 'evidence-based medicine (EBM) education']","['EBM knowledge and self-efficacy', 'Fresno and self-efficacy tests', 'posttest scores', 'Self-efficacy']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0031833', 'cui_str': 'Physician assistant'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0376537', 'cui_str': 'Medicine, Evidence-Based'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0031833', 'cui_str': 'Physician assistant'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0376537', 'cui_str': 'Medicine, Evidence-Based'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",61.0,0.043621,Higher Fresno pretest scores were significantly related to decreasing improvements in the posttest scores:,"[{'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Stack', 'Affiliation': 'Matthew A. Stack, DHA, PA-C, is an adjunct professor for behavior health at the MSU/MidMichigan Gratiot Family Medicine Residency Program in Alma, Michigan. Nailya O. DeLellis, PhD, MPH, is an associate professor in the Health Administration Program, College of Health Professions, at Central Michigan University in Mt. Pleasant, Michigan. Wallace Boeve, EdD, PA-C, is the program director for the Physician Assistant Program at Bethel University in St. Paul, Minnesota. Robert C. Satonik, MD, is an associate professor at the Medical College of Georgia at Augusta University and assistant dean for clinical curriculum at the Augusta University-University of Georgia Medical Partnership in Athens, Georgia.'}, {'ForeName': 'Nailya O', 'Initials': 'NO', 'LastName': 'DeLellis', 'Affiliation': ''}, {'ForeName': 'Wallace', 'Initials': 'W', 'LastName': 'Boeve', 'Affiliation': ''}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Satonik', 'Affiliation': ''}]",The journal of physician assistant education : the official journal of the Physician Assistant Education Association,['10.1097/JPA.0000000000000313']
2522,32810344,A pilot study using a small-sided games program to modify cardiovascular health in sedentary Indigenous men.,"ISSUES ADDRESSED


To determine cardiovascular health benefits in Indigenous men following short-duration small-sided games.
METHODS


Fourteen sedentary Indigenous males (35.6 SD 7.2 years), randomly assigned to a small-sided games (SSG) or a non-exercising control. Small-sided 20-minute (4 x 5 minute bouts) games of touch-football were played 2 x /week for 9 weeks. Waist and hip circumferences, height, total body mass (kg), fat (%), fat free mass (kg), muscle mass (kg), resting heart rate (bpm), systolic blood pressure (mmHg), total cholesterol and high-density lipid concentrations were measured and waist-hip ratios, body mass index (BMI), heart rate variability (HRV), metabolic age and Framingham risk calculated before and after the exercise invention. Between group differences were examined using unpaired t-tests (welch corrected) and described using Cohen's effect size (ES) differences.
RESULTS


Significant between group differences favouring the SSG group were observed in body mass (p = 0.039, ES = 0.2), BMI (p = 0.031, ES = 0.24) and metabolic age (p = 0.033, ES = 0.32) and in HRV parametes of approximate entropy (ApEN; p = 0.01, ES = 1.82) and sample entropy (SampEN; p = 0.0193, ES = 1.55).
CONCLUSION


Middle aged Indigenous men can gain cardiovascular health benefits following short-bouts of small-sided game play accumulating in 40-minutes of exercise each week. SO WHAT?: Short duration SSG may address many exercise barriers, and offer a sustainable form of exercise to improve cardiovascular health amongst Indigenous men.",2020,"RESULTS


Significant between group differences favouring the SSG group were observed in body mass (p = 0.039, ES = 0.2), BMI (p = 0.031, ES = 0.24) and metabolic age (p = 0.033, ES = 0.32) and in HRV parametes of approximate entropy (ApEN; p = 0.01, ES = 1.82) and sample entropy (SampEN; p = 0.0193, ES = 1.55).
CONCLUSION


Middle aged Indigenous men can gain cardiovascular health benefits following short-bouts of small-sided game play accumulating in 40-minutes of exercise each week.","['Indigenous men', 'Fourteen sedentary Indigenous males (35.6 SD 7.2 years', 'Indigenous men following short-duration small-sided games', 'sedentary Indigenous men']","['small-sided games program', 'small-sided games (SSG) or a non-exercising control']","['Waist and hip circumferences, height, total body mass (kg), fat (%), fat free mass (kg), muscle mass (kg), resting heart rate (bpm), systolic blood pressure (mmHg), total cholesterol and high-density lipid concentrations were measured and waist-hip ratios, body mass index (BMI), heart rate variability (HRV), metabolic age and Framingham risk calculated', 'body mass', 'BMI']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}]",14.0,0.0775729,"RESULTS


Significant between group differences favouring the SSG group were observed in body mass (p = 0.039, ES = 0.2), BMI (p = 0.031, ES = 0.24) and metabolic age (p = 0.033, ES = 0.32) and in HRV parametes of approximate entropy (ApEN; p = 0.01, ES = 1.82) and sample entropy (SampEN; p = 0.0193, ES = 1.55).
CONCLUSION


Middle aged Indigenous men can gain cardiovascular health benefits following short-bouts of small-sided game play accumulating in 40-minutes of exercise each week.","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Sampson', 'Affiliation': 'Centre of Medical and Exercise Physiology, School of Medicine, University of Wollongong, Northfields Ave, Wollongong, NSW, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Venables', 'Affiliation': 'Illawarra Aboriginal Medical Service, Church Street, Wollongong, NSW, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Debeneditics', 'Affiliation': 'Talent Department, South Australian National Football League, War Memorial Drive, Adelaide, SA, Australia.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Peoples', 'Affiliation': 'Centre of Medical and Exercise Physiology, School of Medicine, University of Wollongong, Northfields Ave, Wollongong, NSW, Australia.'}]",Health promotion journal of Australia : official journal of Australian Association of Health Promotion Professionals,['10.1002/hpja.409']
2523,32810355,A cluster-randomized study on the Risk Assessment and Management Program for home blood pressure monitoring in an older population with inadequate health literacy.,"The Risk Assessment and Management Program (RAMP) has successfully demonstrated a reduction of blood pressure (BP) and cardiovascular (CVD) risk of patients with hypertension. This study aimed to compare the blood pressure control rate of participants after attended RAMP group, with those attended RAMP individual from usual care. A prospective open cluster-randomized controlled trial was performed in five public primary care clinics. Patients with uncontrolled hypertension were recruited. RAMP group consisted of multi-disciplinary group education on knowledge of hypertension, lifestyle modification, and hands-on home blood pressure monitoring (HBPM) training. Each participant was given a branchial HBPM device. An individual face-to-face nurse follow-up was arranged 6 weeks later. Participants' office BP and clinical parameters were assessed at 6, 12, and 18 months. Three RAMP group and two RAMP-individual clusters recruited 152 and 139 participants, respectively. The mean age was 67.0 (SD 9.9) year. After 18 months of treatment, there was a significantly higher BP control rate in the RAMP-group participants than the RAMP-individual participants (78.9% vs 36.5%, P < .001). The systolic BP was reduced by 19.7 mm Hg (95% CI -22.03, -17.40, P < .001) and diastolic BP by 8.1 mm Hg (95% CI -9.66, -6.61, P < .001) in RAMP group while the RAMP individual demonstrated 9.3 mm Hg (95% CI -12.1, -6.4, P < .001) reduction in systolic BP without any significant difference in diastolic BP. The RAMP-group participants' body weight (BW) and body mass index(BMI) had no significant changes, while the RAMP-individual participants had a significant increase in BW and BMI. No adverse effect was reported.",2020,"After 18 months of treatment, there was a significantly higher BP control rate in the RAMP-group participants than the RAMP-individual participants (78.9% vs 36.5%, P ","['five public primary care clinics', 'Patients with uncontrolled hypertension', 'older population with inadequate health literacy', 'patients with hypertension', 'participants after attended RAMP group, with those attended RAMP individual from usual care']","['multi-disciplinary group education on knowledge of hypertension, lifestyle modification, and hands-on home blood pressure monitoring (HBPM) training', 'Risk Assessment and Management Program']","['blood pressure (BP) and cardiovascular (CVD) risk', 'diastolic BP', 'BW and BMI', 'BP control rate', 'systolic BP', 'body weight (BW) and body mass index(BMI', 'blood pressure control rate', 'adverse effect']","[{'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0150375', 'cui_str': 'Group education'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",5.0,0.0327305,"After 18 months of treatment, there was a significantly higher BP control rate in the RAMP-group participants than the RAMP-individual participants (78.9% vs 36.5%, P ","[{'ForeName': 'Sau Nga', 'Initials': 'SN', 'LastName': 'Fu', 'Affiliation': 'Ha Kwai Chung General Outpatient Clinic, Department of Family Medicine and Primary Health Care, Kowloon West Cluster, Hospital Authority, Kwai Chung, N.T., Hong Kong.'}, {'ForeName': 'Man Chi', 'Initials': 'MC', 'LastName': 'Dao', 'Affiliation': 'Ha Kwai Chung General Outpatient Clinic, Department of Family Medicine and Primary Health Care, Kowloon West Cluster, Hospital Authority, Kwai Chung, N.T., Hong Kong.'}, {'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Luk', 'Affiliation': 'Ha Kwai Chung General Outpatient Clinic, Department of Family Medicine and Primary Health Care, Kowloon West Cluster, Hospital Authority, Kwai Chung, N.T., Hong Kong.'}, {'ForeName': 'Margaret Choi Hing', 'Initials': 'MCH', 'LastName': 'Lam', 'Affiliation': 'Hong Kong Academy of Nursing - HKCCPHN, LG1, School of Nursing, Princess Margaret Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Irene Sau Fan', 'Initials': 'ISF', 'LastName': 'Ho', 'Affiliation': 'Ha Kwai Chung General Outpatient Clinic, Department of Family Medicine and Primary Health Care, Kowloon West Cluster, Hospital Authority, Kwai Chung, N.T., Hong Kong.'}, {'ForeName': 'Siu Keung', 'Initials': 'SK', 'LastName': 'Cheung', 'Affiliation': 'Department of Sociology, Hong Kong Shue Yan University, North Point, Hong Kong.'}, {'ForeName': 'Carlos King Ho', 'Initials': 'CKH', 'LastName': 'Wong', 'Affiliation': 'Department of Family Medicine and Primary Care, The University of Hong Kong, Ap Lei Chau, Hong Kong.'}, {'ForeName': 'Bernard Man Yung', 'Initials': 'BMY', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Pok Fu Lam, Hong Kong.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13987']
2524,32810358,Association between serum 25-hydroxyvitamin D and the effects of Angiotensin II receptor blocker on renal function among African Americans: A post hoc analysis of a randomized placebo-controlled trial.,"We tested the hypothesis that vitamin D status may modify the effect of Angiotensin II receptor blocker (ARB) on renal function among African Americans. Sixty-four participants were included in this ancillary study from a randomized, double-blind, placebo-controlled, crossover trial among normotensive African Americans to test the effect of ARB on stress response of blood pressure and renal sodium handling. The participants were randomly assigned to receive either ARB or placebo for one week, washed out for one week and then cross-overed to receive the other intervention for one week. On the final day of each intervention, the participant underwent a mental stress test. Baseline serum 25-hydroxyvitamin D [25(OH)D] level was measured in this ancillary study. Sixty-four participants were included, aged 26.5 ± 10.2 years and 47% were female. Among the participants with the serum 25(OH)D concentrations in the low tertile, ARB treatment was associated with 2.58 mg/dL higher blood urea nitrogen (BUN) (P < .001) and was not associated with serum creatinine (SCr) or estimated glomerular filtration rate (eGFR) (Ps > .05). Among the participants in the high 25(OH)D tertile, ARB was associated with 1.59 mg/dL lower BUN (P < .001), 0.08 mg/dL lower SCr (P = .001), and 8.59 mL/min/1.73 m 2  higher eGFR (P = .001). The interactions between vitamin D and ARB on renal function were more significant during stress and recovery than at rest. The effects of ARB treatment on renal function are modified by the vitamin D status among African Americans. ARB may improve renal function only among the ones with optimal vitamin D status.",2020,The interactions between vitamin D and ARB on renal function were more significant during stress and recovery than at rest.,"['Sixty-four participants', 'African Americans', 'normotensive African Americans', 'Sixty-four participants were included, aged 26.5\xa0±\xa010.2\xa0years and 47% were female']","['ARB', 'Angiotensin II receptor blocker (ARB', 'Angiotensin II receptor blocker', 'vitamin D and ARB', 'ARB or placebo', 'placebo']","['serum 25(OH)D concentrations', 'Baseline serum 25-hydroxyvitamin D [25(OH)D] level', 'blood urea nitrogen (BUN', 'renal function', 'ARB', 'serum creatinine (SCr) or estimated glomerular filtration rate (eGFR) ', 'stress response of blood pressure and renal sodium handling']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}]",64.0,0.182473,The interactions between vitamin D and ARB on renal function were more significant during stress and recovery than at rest.,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, Georgia, USA.'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, Georgia, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Harshfield', 'Affiliation': 'Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, Georgia, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, Georgia, USA.'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, Georgia, USA.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13997']
2525,32810363,The potential benefit of continuous metered-dose inhaler inhalation technique verbal counselling on asthmatic.,"BACKGROUND


Subjects' improper usage of their metered-dose inhalers (MDI) is considered a chief cause of poor asthma control. The work presented here aims to evaluate the effect of MDI verbal counselling on subjects' lung function and inhalation technique.
METHOD


A total number of 900 asthmatic subjects (450 female) were gathered from University hospital outpatient clinics from January 2017 to May 2019 with a mean(SD) age 45.2(17.1) years old. They were divided into 2 groups. The first was monthly asthma follow up, for 3 visits, (450 (266 females) subjects). The other group was monthly asthma follow up, for 3 visits plus MDI inhalation technique verbal counselling (450 (184 female) subjects). At the beginning of studying group 2 and at every monthly visit (three visits), each subject was asked to show the investigator his MDI inhalation technique and the number of mistakes was noticed and adjusted. Additionally, at each visit, their forced expiratory volume in one second (FEV 1  ) as a percentage of the forced vital capacity (FVC) and peak expiratory flow (PEF) were measured.
RESULTS


No subject dropped out from group 2; however, 95 subjects dropped out from group 1 with no improvement in the lung function tests. The mean number of accurate steps of the MDI inhalation technique observed in group 2 was improved significantly (p<0.001) as the number of visits increased particularly in children. ""Start to inhale slowly, through the mouth and at the same time press the canister to actuate a dose and maintain a slow and deep inhalation, through the mouth, until the lungs are full of air (This should take an adult 4-5 seconds)"" was the common repetitive mistake. There was a significant improvement (p<0.05) in the lung function test scores after the counselling in group 2, especially in old subjects.
CONCLUSIONS


MDI's counselling must be continually offered to the asthmatic subject at any possible chance to improve and sustain the optimal MDI inhalation technique and probably improve subjects' lung function score.",2020,"There was a significant improvement (p<0.05) in the lung function test scores after the counselling in group 2, especially in old subjects.
","['450 (184 female) subjects', ""subjects' lung function and inhalation technique"", 'asthmatic', 'A total number of 900 asthmatic subjects (450 female) were gathered from University hospital outpatient clinics from January 2017 to May 2019 with a mean(SD) age 45.2(17.1) years old']","['MDI inhalation technique verbal counselling', 'MDI verbal counselling']","['forced vital capacity (FVC) and peak expiratory flow (PEF', 'mean number of accurate steps of the MDI inhalation technique', 'lung function tests', 'lung function test scores', 'number of visits']","[{'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C1998547', 'cui_str': 'Inhalation technique'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0665509', 'cui_str': 'OF 900'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1998547', 'cui_str': 'Inhalation technique'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0030771', 'cui_str': 'Pefloxacin'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C1998547', 'cui_str': 'Inhalation technique'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",900.0,0.0115041,"There was a significant improvement (p<0.05) in the lung function test scores after the counselling in group 2, especially in old subjects.
","[{'ForeName': 'Xingai', 'Initials': 'X', 'LastName': 'Jiao', 'Affiliation': 'Respiratory Medicine Department, Qilu Hospital of Shandong University, Jinan, Shandong Province, 250012, China.'}, {'ForeName': 'Dongqin', 'Initials': 'D', 'LastName': 'Sheng', 'Affiliation': 'Respiratory Medicine Department, Qilu Hospital of Shandong University, Jinan, Shandong Province, 250012, China.'}, {'ForeName': 'Xiangqiao', 'Initials': 'X', 'LastName': 'Zhan', 'Affiliation': 'Extracardiac ICU, Qilu Hospital of Shandong University, Jinan, Shandong Province, 250012, China.'}, {'ForeName': 'Yufang', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'Neurology Department, Qilu Hospital of Shandong University, No.107, Culture West Road, Jinan, Shandong Province, 250012, China.'}]",International journal of clinical practice,['10.1111/ijcp.13682']
2526,32810553,Hyperprogressive disease during PD-1 blockade in patients with advanced hepatocellular carcinoma.,"BACKGROUND AND AIMS


PD-1 inhibitor treatment can cause hyperprogressive disease (HPD), but the incidence, outcome, and predictive factors of HPD are unknown in hepatocellular carcinoma (HCC) patients treated with PD-1 blockade. Here, we assessed existence and factors predictive of HPD in advanced HCC patients treated with nivolumab.
METHODS


Advanced HCC patients treated with nivolumab (n=189) were enrolled. Occurrence of HPD was investigated using tumour growth dynamics based on tumour growth kinetics (TGK) and tumour growth rate (TGR) before and after treatment or time to treatment failure. We additionally analysed patients treated with regorafenib (n=95) or best supportive care (BSC)/placebo (n=103) after progression with sorafenib for comparison of tumour growth dynamics.
RESULTS


A fraction of patients showed flare-up of tumour growth upon PD-1 blockade, indicating the occurrence of HPD. Based on distinct patterns of disease progression exclusively observed in nivolumab, but not in regorafenib or BSC/placebo-treated cohort, we determined 4-fold increases in TGK and TGR ratios and 40% increase in TGR as cut-off values to define HPD and found that 12.7% of the patients (24/189) treated with nivolumab met all these criteria. Patients with HPD had worse progression-free survival (hazard ratio [HR]: 2.194; 95% confidence interval [CI]: 1.214-3.964) and overall survival (HR: 2.238; 95% CI: 1.233-4.062) compared with patients with progressive disease without HPD. More than 90% of patients with HPD missed the opportunity for subsequent treatment because of rapid clinical deterioration. An elevated neutrophil-to-lymphocyte ratio (> 4.125) was associated with HPD and an inferior survival rate.
CONCLUSIONS


HPD exists in a fraction of HCC patients who received PD-1 blockade. Analyses of the baseline immune profile and on-treatment tumour growth dynamics could promote optimal patient selection and earlier identification of rapid tumour growth induced by PD-1 inhibitors in HCC patients.",2020,"An elevated neutrophil-to-lymphocyte ratio (> 4.125) was associated with HPD and an inferior survival rate.
","['Advanced HCC patients treated with nivolumab (n=189) were enrolled', 'advanced HCC patients treated with nivolumab', 'hepatocellular carcinoma (HCC) patients treated with PD-1 blockade', 'patients with advanced hepatocellular carcinoma']","['regorafenib (n=95) or best supportive care (BSC)/placebo (n=103) after progression with sorafenib', 'PD-1 blockade']","['progression-free survival', 'overall survival', 'HPD and an inferior survival rate', 'TGR', 'TGK and TGR ratios', 'tumour growth kinetics (TGK) and tumour growth rate (TGR', 'elevated neutrophil-to-lymphocyte ratio']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0449249', 'cui_str': 'Growth rate'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0151683', 'cui_str': 'Neutrophilia'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}]",189.0,0.141503,"An elevated neutrophil-to-lymphocyte ratio (> 4.125) was associated with HPD and an inferior survival rate.
","[{'ForeName': 'Chang Gon', 'Initials': 'CG', 'LastName': 'Kim', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea; Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Kim', 'Affiliation': 'Medical Oncology, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Korea.'}, {'ForeName': 'Sang Eun', 'Initials': 'SE', 'LastName': 'Yoon', 'Affiliation': 'Division of Hemato-Oncology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung Hwan', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea; Department of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seong Jin', 'Initials': 'SJ', 'LastName': 'Choi', 'Affiliation': 'Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'Beodeul', 'Initials': 'B', 'LastName': 'Kang', 'Affiliation': 'Medical Oncology, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Korea.'}, {'ForeName': 'Hye Ryun', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Su-Hyung', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'Eui-Cheol', 'Initials': 'EC', 'LastName': 'Shin', 'Affiliation': 'Graduate School of Medical Science and Engineering, Korea Advanced Institute of Science and Technology, Daejeon, Korea.'}, {'ForeName': 'Yeun-Yoon', 'Initials': 'YY', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Dae Jung', 'Initials': 'DJ', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, CHA Bundang Medical Center, CHA University, Seongnam, Korea.'}, {'ForeName': 'Hyun Cheol', 'Initials': 'HC', 'LastName': 'Chung', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hong Jae', 'Initials': 'HJ', 'LastName': 'Chon', 'Affiliation': 'Medical Oncology, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Korea. Electronic address: minidoctor@cha.ac.kr.'}, {'ForeName': 'Hye Jin', 'Initials': 'HJ', 'LastName': 'Choi', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea. Electronic address: choihj@yuhs.ac.'}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Division of Hemato-Oncology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. Electronic address: hoylim@skku.edu.'}]",Journal of hepatology,['10.1016/j.jhep.2020.08.010']
2527,32810697,A comparison of young children's spatiotemporal measures of walking and running in three common types of footwear compared to bare feet.,"BACKGROUND


Clinicians and footwear manufacturers often advise young children to wear soft-soled footwear when they are first learning to walk. There is limited evidence as to why this advice is given, and if soft-soled shoes are as close to barefoot as thought.
RESEARCH QUESTION


What are the differences in spatiotemporal measures of gait during walking and running in three common types of children's footwear with a soft-soled compared to barefoot in young children?
METHODS


The study used a quasi-experimental design, with the condition order randomised using a Latin square sequence. Forty-seven children were recruited (2 - 4 years). Participants walked or ran the length of a GAITrite mat in a randomized order for barefoot and soft-soled sneaker, boot and sandal conditions. Linear regression analyses were used to investigate the main effect of each soft-soled footwear compared to bare feet in the different gait parameters.
RESULTS


For walking and running trials, cadence decreased whereas step time and stride length increased in all footwear types compared to the barefoot condition. While wearing sneakers and sandals increased the stance percentage for walking and running trials, compared to barefoot, this difference was only apparent during the running trial for the boots. Likewise, although double support time increased for both the boots and sneakers in walking and running, compared to barefoot, this difference was only observed in the sandals during walking.
SIGNIFICANCE


This research found that various types of soft-soled footwear impacted gait compared to the barefoot condition, with some differences seen between walking and running trials. These findings challenge the assumption that soft-soled footwear facilitate a similar gait to barefoot walking and running, although the clinical significance of these differences is unknown.",2020,", cadence decreased whereas step time and stride length increased in all footwear types compared to the barefoot condition.",['Forty-seven children were recruited (2 - 4\u202fyears'],[],['step time and stride length'],"[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",47.0,0.0330217,", cadence decreased whereas step time and stride length increased in all footwear types compared to the barefoot condition.","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Cranage', 'Affiliation': 'Department of Physiotherapy, Monash University, Melbourne, Australia; Peninsula Health, Melbourne, Victoria, Australia. Electronic address: simone.cranage@monash.edu.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Perraton', 'Affiliation': 'Department of Physiotherapy, Monash University, Melbourne, Australia.'}, {'ForeName': 'Kelly-Ann', 'Initials': 'KA', 'LastName': 'Bowles', 'Affiliation': 'Department of Paramedicine, Monash University, Melbourne, Australia.'}, {'ForeName': 'Cylie', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Department of Physiotherapy, Monash University, Melbourne, Australia; Peninsula Health, Melbourne, Victoria, Australia.'}]",Gait & posture,['10.1016/j.gaitpost.2020.07.147']
2528,32555601,"IMRAS-A clinical trial of mosquito-bite immunization with live, radiation-attenuated P. falciparum sporozoites: Impact of immunization parameters on protective efficacy and generation of a repository of immunologic reagents.","BACKGROUND


Immunization with radiation-attenuated sporozoites (RAS) by mosquito bite provides >90% sterile protection against Plasmodium falciparum (Pf) malaria in humans. RAS invade hepatocytes but do not replicate. CD8+ T cells recognizing parasite-derived peptides on the surface of infected hepatocytes are likely the primary protective mechanism. We conducted a randomized clinical trial of RAS immunization to assess safety, to achieve 50% vaccine efficacy (VE) against controlled human malaria infection (CHMI), and to generate reagents from protected and non-protected subjects for future identification of protective immune mechanisms and antigens.
METHODS


Two cohorts (Cohort 1 and Cohort 2) of healthy, malaria-naïve, non-pregnant adults age 18-50 received five monthly immunizations with infected (true-immunized, n = 21) or non-infected (mock-immunized, n = 5) mosquito bites and underwent homologous CHMI at 3 weeks. Immunization parameters were selected for 50% protection based on prior clinical data. Leukapheresis was done to collect plasma and peripheral blood mononuclear cells.
RESULTS


Adverse event rates were similar in true- and mock-immunized subjects. Two true- and two mock-immunized subjects developed large local reactions likely caused by mosquito salivary gland antigens. In Cohort 1, 11 subjects received 810-1235 infected bites; 6/11 (55%) were protected against CHMI vs. 0/3 mock-immunized and 0/6 infectivity controls (VE 55%). In Cohort 2, 10 subjects received 839-1131 infected bites with a higher first dose and a reduced fifth dose; 9/10 (90%) were protected vs. 0/2 mock-immunized and 0/6 controls (VE 90%). Three/3 (100%) protected subjects administered three booster immunizations were protected against repeat CHMI vs. 0/6 controls (VE 100%). Cohort 2 uniquely showed a significant rise in IFN-γ responses after the third and fifth immunizations and higher antibody responses to CSP.
CONCLUSIONS


PfRAS were generally safe and well tolerated. Cohort 2 had a higher first dose, reduced final dose, higher antibody responses to CSP and significant rise of IFN-γ responses after the third and fifth immunizations. Whether any of these factors contributed to increased protection in Cohort 2 requires further investigation. A cryobank of sera and cells from protected and non-protected individuals was generated for future immunological studies and antigen discovery.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01994525.",2020,"Cohort 2 uniquely showed a significant rise in IFN-γ responses after the third and fifth immunizations and higher antibody responses to CSP.
","['Two cohorts (Cohort 1 and Cohort 2) of healthy, malaria-naïve, non-pregnant adults', 'age 18-50 received five monthly immunizations with infected (true-immunized, n = 21) or']","['mosquito-bite immunization with live, radiation-attenuated P. falciparum sporozoites', 'non-infected (mock-immunized, n = 5) mosquito bites and underwent homologous CHMI', 'radiation-attenuated sporozoites (RAS']","['IFN-γ responses', 'large local reactions', 'safe and well tolerated', 'IMRAS']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0205238', 'cui_str': 'True'}]","[{'cui': 'C0417744', 'cui_str': 'Mosquito bite'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0562648', 'cui_str': 'Kingdom Protozoa sporozoite'}, {'cui': 'C0562577', 'cui_str': 'Mocking'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0853813', 'cui_str': 'Local reaction'}]",,0.0905143,"Cohort 2 uniquely showed a significant rise in IFN-γ responses after the third and fifth immunizations and higher antibody responses to CSP.
","[{'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Hickey', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Nimfa', 'Initials': 'N', 'LastName': 'Teneza-Mora', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Lumsden', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Sharina', 'Initials': 'S', 'LastName': 'Reyes', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sedegah', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Garver', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, United States of America.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Hollingdale', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Jo Glenna', 'Initials': 'JG', 'LastName': 'Banania', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Harini', 'Initials': 'H', 'LastName': 'Ganeshan', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Dowler', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, United States of America.'}, {'ForeName': 'Anatalio', 'Initials': 'A', 'LastName': 'Reyes', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Tamminga', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Singer', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Simmons', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Belmonte', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Arnel', 'Initials': 'A', 'LastName': 'Belmonte', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Inoue', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Velasco', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Abot', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Carlos S', 'Initials': 'CS', 'LastName': 'Vasquez', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Ivelese', 'Initials': 'I', 'LastName': 'Guzman', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Twomey', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, United States of America.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Wojnarski', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Moon', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, United States of America.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Alcorta', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Santina', 'Initials': 'S', 'LastName': 'Maiolatesi', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Spring', 'Affiliation': 'Henry M. Jackson Foundation, Bethesda, MD, United States of America.'}, {'ForeName': 'Silas', 'Initials': 'S', 'LastName': 'Davidson', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, United States of America.'}, {'ForeName': 'Sidhartha', 'Initials': 'S', 'LastName': 'Chaudhury', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, United States of America.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Villasante', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Richie', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Epstein', 'Affiliation': 'Malaria Department, Naval Medical Research Center, Silver Spring, MD, United States of America.'}]",PloS one,['10.1371/journal.pone.0233840']
2529,32573166,[Biomechanical study on femoroplasty-augmentation for prevention of osteoporotic hip fractures].,"OBJECTIVE


To explore whether femoral plasty can improve the fracture resistance of osteoporotic femoral specimens and prevent hip fracture, and to compare the difference of mechanical strength changes between two different femoral plasty methods in osteoporotic femoral specimens, so as to determine the best strengthening area of the plasty.
METHODS


Eighteen pairs of fresh osteoporotic femur specimens were collected and divided into two groups, A and B, 9 pairs in each group. Nine fresh osteoporotic femur specimens in each group were randomly selected for enhancement, and the corresponding contralateral specimens were used as control group. In group A1, the enhancement areas were femoral head, femoral neck, femoral trochanter and subtrochantericregion. And in group B1, the enhancement areas were femoral head, femoral neck and femoral trochanter region. The amount of cement injected into the femoral neck was recorded and the surface temperature of the femoral neck was measured. All specimens were biomechanically tested under simulated falls. Load-displacement curves, final loads were recorded. The final energy and stiffness of specimens were calculated. The biomechanical differences between the specimens of the enhancement group and those of the corresponding control group were compared, and the mechanical changes of the specimens by two different enhancement methods were compared.
RESULTS


Compared with the control group, the ultimate load and energy of the specimens in the enhanced group increased significantly, but the stiffness did not change significantly. There was no significant difference in final load and energy between specimens strengthened by two different methods.
CONCLUSION


Femoral plasty has the advantages of minimally invasive, simple operationand remarkable effect. It can be used as a new method to prevent osteoporotic hip fracture.",2020,"There was no significant difference in final load and energy between specimens strengthened by two different methods.
","['osteoporotic hip fractures', 'Eighteen pairs of fresh osteoporotic femur specimens']","['femoral plasty', 'femoroplasty-augmentation']","['fracture resistance', 'ultimate load and energy of the specimens', 'final load and energy']","[{'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}]",18.0,0.0153905,"There was no significant difference in final load and energy between specimens strengthened by two different methods.
","[{'ForeName': 'Shao-Kun', 'Initials': 'SK', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopaedics, Huamei Hospital, University of Chinese Academy of Science, Ningbo 315010, Zhejiang, China.'}, {'ForeName': 'Yao-Jun', 'Initials': 'YJ', 'LastName': 'Wu', 'Affiliation': 'Department of Orthopaedics, Huamei Hospital, University of Chinese Academy of Science, Ningbo 315010, Zhejiang, China.'}, {'ForeName': 'Zhi-Qian', 'Initials': 'ZQ', 'LastName': 'Gu', 'Affiliation': 'Department of Orthopaedics, Huamei Hospital, University of Chinese Academy of Science, Ningbo 315010, Zhejiang, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Orthopaedics, Huamei Hospital, University of Chinese Academy of Science, Ningbo 315010, Zhejiang, China.'}]",Zhongguo gu shang = China journal of orthopaedics and traumatology,['10.12200/j.issn.1003-0034.2020.06.017']
2530,31369680,Temporal muscle thickness is an independent prognostic marker in patients with progressive glioblastoma: translational imaging analysis of the EORTC 26101 trial.,"BACKGROUND


Temporal muscle thickness (TMT) was described as a surrogate marker of skeletal muscle mass. This study aimed to evaluate the prognostic relevance of TMT in patients with progressive glioblastoma.
METHODS


TMT was analyzed on cranial MR images of 596 patients with progression of glioblastoma after radiochemotherapy enrolled in the European Organisation for Research and Treatment of Cancer 26101 trial. An optimal TMT cutoff for overall survival (OS) and progression-free survival (PFS) was defined in the training cohort (n = 260, phase II). Patients were grouped as ""below"" or ""above"" the TMT cutoff and associations with OS and PFS were tested using the Cox model adjusted for important risk factors. Findings were validated in a test cohort (n = 308, phase III).
RESULTS


An optimal baseline TMT cutoff of 7.2 mm was obtained in the training cohort for both OS and PFS (area under the curve = 0.64). Univariate analyses estimated a hazard ratio (HR) of 0.54 (95% CI: 0.42, 0.70; P < 0.0001) for OS and an HR of 0.49 (95% CI: 0.38, 0.64; P < 0.0001) for PFS for the comparison of training cohort patients above versus below the TMT cutoff. Similar results were obtained in Cox models adjusted for important risk factors with relevance in the trial for OS (HR, 0.54; 95% CI: 0.41, 0.70; P < 0.0001) and PFS (HR, 0.47; 95% CI: 0.36, 0.61; P < 0.0001). Results were confirmed in the validation cohort.
CONCLUSION


Reduced TMT is an independent negative prognostic parameter in patients with progressive glioblastoma and may help to facilitate patient management by supporting patient stratification for therapeutic interventions or clinical trials.",2019,"Univariate analyses estimated a hazard ratio (HR) of 0.54 (95% CI: 0.42, 0.70; P < 0.0001) for OS and an HR of 0.49 (95% CI: 0.38, 0.64; P < 0.0001) for PFS for the comparison of training cohort patients above versus below the TMT cutoff.","['596 patients with progression of glioblastoma after radiochemotherapy enrolled in the European Organisation for Research and Treatment of Cancer 26101 trial', 'patients with progressive glioblastoma']",['TMT'],['overall survival (OS) and progression-free survival (PFS'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0039487', 'cui_str': 'Structure of temporalis muscle'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",596.0,0.144774,"Univariate analyses estimated a hazard ratio (HR) of 0.54 (95% CI: 0.42, 0.70; P < 0.0001) for OS and an HR of 0.49 (95% CI: 0.38, 0.64; P < 0.0001) for PFS for the comparison of training cohort patients above versus below the TMT cutoff.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Furtner', 'Affiliation': 'Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Genbrugge', 'Affiliation': 'European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Gorlia', 'Affiliation': 'European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bendszus', 'Affiliation': 'University Medical Center, Department of Neuroradiology, Heidelberg, Germany.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Nowosielski', 'Affiliation': 'Department of Neurology, Medical University Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Golfinopoulos', 'Affiliation': 'European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Clinical Cooperation Unit, Neuro-Oncology, German Cancer Consortium, German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Martin J', 'Initials': 'MJ', 'LastName': 'van den Bent', 'Affiliation': 'Department of Neurology/Neuro-Oncology, Erasmus MC-Cancer Institute, Rotterdam, Netherlands.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Wick', 'Affiliation': 'Neurology Clinic, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Preusser', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Vienna, Austria.'}]",Neuro-oncology,['10.1093/neuonc/noz131']
2531,31484697,Peri-procedural stroke or death in stenting of symptomatic severe intracranial stenosis.,"BACKGROUND AND PURPOSE


There are limited data on predictors of 30-day stroke or death in patients with symptomatic intracranial atherosclerosis (sICAS) undergoing stenting. We aim to determine the factors associated with stroke or death at 30 days in the stenting arm of the SAMMPRIS trial.
METHODS


This is a post-hoc analysis of the SAMMPRIS trial including patients who underwent angioplasty/stenting. We compared patient-specific variables, lesion-specific variables, procedure-specific variables, and FDA-approved indications between patients with and without the primary outcome (stroke or death at 30 days). Logistic regression analyses were performed to evaluate associations with the primary outcome.
RESULTS


We identified 213 patients, 30 of whom (14.1%) met the primary outcome. Smoking status and lesion length were associated with the primary outcome: the odds of stroke or death for non-smokers versus smokers (adjusted OR 4.46, 95% CI 1.79 to 11.1, p=0.001) and for increasing lesion length in millimeters (adjusted OR 1.20, 95% CI 1.02 to 1.39, p=0.029). These had a modest predictive value: absence of smoking history (sensitivity 66.7%, specificity 65.4%) and lesion length (area under curve 0.606). Furthermore, event rates were not significantly different between patients with and without the FDA-approved indication for stenting (15.9% vs 12%, p=0.437).
CONCLUSION


In SAMMPRIS patients who underwent angioplasty/stenting, neither clinical and neuroimaging variables nor the FDA indication for stenting reliably predicted the primary outcome. Further work in identifying reliable biomarkers of stroke/death in patients with sICAS is needed before considering new clinical trials of stenting.
TRIAL REGISTRATION NUMBER


SAMMPRIS NCT00576693; Results.",2020,"These had a modest predictive value: absence of smoking history (sensitivity 66.7%, specificity 65.4%) and lesion length (area under curve 0.606).","['patients with symptomatic intracranial atherosclerosis (sICAS) undergoing stenting', 'patients who underwent angioplasty/stenting', 'symptomatic severe intracranial stenosis', 'patients with sICAS', '213 patients, 30 of whom (14.1%) met the primary outcome']",['angioplasty/stenting'],"['Smoking status and lesion length', 'odds of stroke or death', 'lesion length', 'event rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0751007', 'cui_str': 'Intracranial Atherosclerosis'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.408369,"These had a modest predictive value: absence of smoking history (sensitivity 66.7%, specificity 65.4%) and lesion length (area under curve 0.606).","[{'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Yaghi', 'Affiliation': 'Department of Neurology, New York Langone Health, New York, NY, USA.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Khatri', 'Affiliation': 'Department of Neurology, University of Cincinnati, Cincinnati, Ohio, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'de Havenon', 'Affiliation': 'Department of Neurology, University of Utah, Salt Lake City, Utah, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Yeatts', 'Affiliation': 'Department of Biostatistics, Bioinformatics and Epidemiology, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Chang', 'Affiliation': 'Department of Neurology, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Shawna', 'Initials': 'S', 'LastName': 'Cutting', 'Affiliation': 'Department of Neurology, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mac Grory', 'Affiliation': 'Department of Neurology, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Burton', 'Affiliation': 'Department of Neurology, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Jayaraman', 'Affiliation': 'Department of Diagnostic Imaging, Brown University Warren Alpert Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'McTaggart', 'Affiliation': 'Department of Neurosurgery, Cleveland Clinic Florida, Weston, Florida, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fiorella', 'Affiliation': 'Department of Neurosurgery, Stony Brook University, Stony Brook, New York, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Derdeyn', 'Affiliation': 'Department of Radiology and Interventional Radiology, University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.'}, {'ForeName': 'Osama O', 'Initials': 'OO', 'LastName': 'Zaidat', 'Affiliation': 'Department of Neuroscience, St Vincent Mercy Hospital, Toledo, Ohio, USA.'}, {'ForeName': 'Seena', 'Initials': 'S', 'LastName': 'Dehkharghani', 'Affiliation': 'NYU Langone Health, New York, New York, USA.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Amin-Hanjani', 'Affiliation': 'Neurosurgery, University of Illinois, Chicago, Illinois, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Furie', 'Affiliation': 'Department of Neurology, Rhode Island Hospital, Providence, Rhode Island, USA.'}, {'ForeName': 'Shyam', 'Initials': 'S', 'LastName': 'Prahbakaran', 'Affiliation': 'Neurology, University of Chicago, Chicago, Illinois, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Liebeskind', 'Affiliation': 'Department of Neurology, UCLA, Los Angeles, California, USA.'}]",Journal of neurointerventional surgery,['10.1136/neurintsurg-2019-015225']
2532,32814120,Development and preliminary testing of a technology-enhanced intervention to improve energy intake regulation in children.,"Interventions designed to improve children's self-regulation of energy intake have yielded mixed results. We tested the efficacy of a technology-enhanced intervention designed to teach children to eat in response to internal hunger and fullness cues. Thirty-two children (mean age 4.9 ± 0.8 y) completed this within-subjects, pre-post design study that took place across 10 laboratory sessions, each scheduled approximately 1 week apart. The intervention was conducted across weeks 4-7 in small groups focused on teaching children how food travels through the body and how to respond to hunger and fullness signals. Children's short-term energy compensation, a measure of intake regulation, was collected at baseline and follow-up using a preloading protocol. Twenty-five minutes prior to receiving a standardized test meal, children consumed a low-energy (3 kcal) or high-energy (150 kcal) preload beverage, presented in random order at baseline and follow-up. Knowledge of intervention concepts was also assessed at baseline and follow-up. Linear mixed models were used to examine changes in short-term energy compensation and knowledge from baseline to follow-up. Knowledge related to the intervention improved from baseline to follow-up (3.5 ± 0.3 to 7.0 ± 0.3 correct responses out of a possible 10; P < 0.001). Children's energy compensation also improved from baseline to follow-up, as evidenced by a time-by-preload condition interaction (P = 0.02). However, this improvement was driven by boys who increased the adjustment for beverage energy content from baseline to follow-up (P = 0.04). Girls showed no change in energy compensation with the intervention (P = 0.58). The overall increase in knowledge, paired with the improvement in energy compensation in boys, suggests that this technology-enhanced intervention may be efficacious for some children. Further research is needed to determine whether boys and girls will benefit from different, personalized intervention strategies for obesity prevention.",2020,Girls showed no change in energy compensation with the intervention (P = 0.58).,"['Thirty-two children (mean age 4.9\u202f±\u202f0.8\u202fy) completed this within-subjects, pre-post design study that took place across 10 laboratory sessions', 'children']","['technology-enhanced intervention', 'standardized test meal, children consumed a low-energy (3\u202fkcal) or high-energy (150\u202fkcal) preload beverage']","['energy compensation', ""Children's energy compensation""]","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0152057', 'cui_str': 'Compensation'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",32.0,0.0189846,Girls showed no change in energy compensation with the intervention (P = 0.58).,"[{'ForeName': 'Nicole A', 'Initials': 'NA', 'LastName': 'Reigh', 'Affiliation': 'The Pennsylvania State University, Department of Nutritional Sciences. 110 Chandlee Laboratory, University Park, PA, 16802, USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Rolls', 'Affiliation': 'The Pennsylvania State University, Department of Nutritional Sciences. 226 Henderson Building, University Park, PA, 16802, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Savage', 'Affiliation': 'The Pennsylvania State University, Center for Childhood Obesity Research and Department of Nutritional Sciences. 129 Noll Laboratory, University Park, PA, 16802, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Johnson', 'Affiliation': 'University of Colorado Denver Anschutz Medical Campus, Department of Pediatrics. 12631 East 17th Avenue, Mail Stop F-561, Academic Office Building, Room 2609; Aurora, CO, 80045, USA.'}, {'ForeName': 'Kathleen L', 'Initials': 'KL', 'LastName': 'Keller', 'Affiliation': 'The Pennsylvania State University, Departments of Nutritional Sciences and Food Science. 321 Chandlee Laboratory, University Park, PA, 16802, USA. Electronic address: klk37@psu.edu.'}]",Appetite,['10.1016/j.appet.2020.104830']
2533,32814123,Application of continuous passive motion in patients with distal radius fractures: A randomized clinical trial.,"The aim of this study was to know if applying continuous passive motion (CPM) in addition to routine exercises is more effective than routine exercises alone in pain reduction, range of motion (ROM) and function improvement after distal radius fractures (DRFs). In this randomized controlled trial, 21 patients with non-stabilized DRF after pin removal were randomly assigned to experimental and control groups. The experimental group received stretching exercises with CPM machine for 2×15minutes per session. Both groups received routine exercises for 1hour, three times a week for 4 weeks. The primary outcome measure was pain evaluated on a visual analog scale (VAS), and the secondary outcome measures were disability evaluated by the patient-rated wrist/hand evaluation and ROM (goniometry) at 4, 6, and 12 weeks. Univariate analysis of covariance (ANCOVA) and a one-way repeated measure mixed model analysis of variance (ANOVA) were used for data analysis. Twenty-one participants completed the 12-week follow-up. Pain relief, ROM and functional improvement revealed that the treatment was successful in both groups. We detected no significant differences (p>0.05) between the two groups at the end of the follow-up period regarding pain, ROM, and function. Using a CPM machine had no additional effect on pain reduction, ROM and function improvement compared with routine exercises in patients with DRF.",2020,"Using a CPM machine had no additional effect on pain reduction, ROM and function improvement compared with routine exercises in patients with DRF.","['patients with DRF', '21 patients with non-stabilized DRF after pin removal', 'patients with distal radius fractures']","['routine exercises', 'CPM machine', 'continuous passive motion', 'stretching exercises with CPM machine', 'continuous passive motion (CPM']","['pain, ROM, and function', 'Pain relief, ROM and functional improvement', 'pain evaluated on a visual analog scale (VAS', 'pain reduction, range of motion (ROM) and function improvement after distal radius fractures (DRFs', 'pain reduction, ROM and function improvement', 'disability evaluated by the patient-rated wrist/hand evaluation and ROM (goniometry']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",21.0,0.0547275,"Using a CPM machine had no additional effect on pain reduction, ROM and function improvement compared with routine exercises in patients with DRF.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shirzadi', 'Affiliation': 'Occupational Therapy, University of Social Welfare and Rehabilitation Sciences, Daneshjoo Blvd, Tehran, Iran. Electronic address: ashirzadi71@gmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Farzad', 'Affiliation': 'Occupational Therapy, University of Social Welfare and Rehabilitation Sciences, Daneshjoo Blvd, Tehran, Iran; Occupational Therapy, University of Western Ontario, London, Ontario, Canada. Electronic address: mfarzad@uwo.ca.'}, {'ForeName': 'A R', 'Initials': 'AR', 'LastName': 'Farhoud', 'Affiliation': 'Orthopedic Surgery, Imam Hospital Complex, Tehran University of Medical Sciences, Joint Reconstruction Research Center. Electronic address: am_farhoud@yahoo.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Shafiee', 'Affiliation': 'Occupational Therapy, University of Western Ontario, London, Ontario, Canada. Electronic address: eshafiee@uwo.ca.'}]",Hand surgery & rehabilitation,['10.1016/j.hansur.2020.08.001']
2534,32814158,Optimal timing of the loop electrosurgical excision procedure according to different phases of the menstrual cycle.,"OBJECTIVE


To determine whether treatment of cervical precancerous lesions in the follicular phase or luteal phase of the menstrual cycle affects perioperative and postoperative blood loss during the LEEP.
METHODS


In this randomized trial, 73 patients were assigned to either the follicular phase group (n = 37) or the luteal phase group (n = 36). Ultimately, the conditions of 36 patients in the follicular phase group and 34 patients in the luteal phase group were analyzed. The primary outcome measure was median early postoperative blood loss. Secondary outcomes were median intraoperative bleeding, the rate of late postoperative bleeding, and persistent vaginal bleeding.
RESULTS


Baseline demographic data were similar in the two groups. Median intraoperative blood loss was significantly lower in the follicular phase group than in the luteal phase group (32.7 [20.1-78.3] vs. 44.6 [30.4-104.2] mL, respectively; P <  0.001). Median early postoperative blood loss was also lower in the follicular phase group than in the luteal phase group (209.2 [67.7-468.6] vs. 289.0 [120.3-552.8] mL, respectively; P =  0.01). Moreover, the rate of late postoperative bleeding was higher in the luteal phase group than in the follicular phase group (20.6% vs. 2.8%, respectively; P =  0.02).
CONCLUSION


Performing LEEP during the follicular phase of the menstrual cycle significantly reduces median intraoperative blood loss, early postoperative blood loss, and the rate of late postoperative blood loss.",2020,"Median intraoperative blood loss was significantly lower in the follicular phase group than in the luteal phase group (32.7 [20.1-78.3] vs. 44.6 [30.4-104.2] mL, respectively; P <  0.001).","['36 patients in the follicular phase group and 34 patients in the luteal phase group were analyzed', '73 patients']",['loop electrosurgical excision procedure'],"['median intraoperative bleeding, the rate of late postoperative bleeding, and persistent vaginal bleeding', 'Median intraoperative blood loss', 'Median early postoperative blood loss', 'rate of late postoperative blood loss', 'median early postoperative blood loss', 'rate of late postoperative bleeding', 'median intraoperative blood loss, early postoperative blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0016434', 'cui_str': 'Menstrual Cycle, Proliferative Phase'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024153', 'cui_str': 'Menstrual Cycle, Luteal Phase'}]","[{'cui': 'C0184930', 'cui_str': 'Loop electrosurgical excision procedure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",73.0,0.0695403,"Median intraoperative blood loss was significantly lower in the follicular phase group than in the luteal phase group (32.7 [20.1-78.3] vs. 44.6 [30.4-104.2] mL, respectively; P <  0.001).","[{'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Gungorduk', 'Affiliation': 'Department of Gynecology and Oncology, Muğla Sitki Koçman University Education and Research Hospital, Muğla, Turkey.'}, {'ForeName': 'Aykut', 'Initials': 'A', 'LastName': 'Ozdemir', 'Affiliation': 'Department of Gynecology and Oncology, Bakirkoy Sadi Konuk Research and Training Hospital, Istanbul, Turkey.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Sahin', 'Affiliation': 'Department of Obstetrics and Gynecology, Okmeydanı Education and Research Hospital, İstanbul, Turkey. Electronic address: drorhansahin@gmail.com.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101888']
2535,32814308,Losing Sleep Over It: Sleep in Basketball Players Affected by Game But Not Training Workloads.,"PURPOSE


To examine the impact of workload volume during training sessions and games on subsequent sleep duration and sleep quality in basketball players.
METHODS


Seven semiprofessional male basketball players were monitored across preseason and in-season phases to determine training session and game workloads, sleep duration, and sleep quality. Training and game data were collected via accelerometers, heart-rate monitors, and rating of perceived exertion (RPE) and reported as PlayerLoad™ (PL), summated heart-rate zones, and session RPE (sRPE). Sleep duration and sleep quality were measured using wrist-worn activity monitors in conjunction with self-report sleep diaries. For daily training sessions and games, all workload data were independently sorted into tertiles representing low, medium, and high workload volumes. Sleep measures following low, medium, and high workloads and control nights (no training/games) were compared using linear mixed models.
RESULTS


Sleep onset time was significantly later following medium and high PL and sRPE game workloads compared with control nights (P < .05). Sleep onset time was significantly later following low, medium, and high summated heart-rate-zones game workloads, compared with control nights (P < .05). Time in bed and sleep duration were significantly shorter following high PL and sRPE game workloads compared with control nights (P < .05). Following low, medium, and high training workloads, sleep duration and quality were similar to control nights (P > .05).
CONCLUSIONS


Following high PL and sRPE game workloads, basketball practitioners should consider strategies that facilitate longer time in bed, such as napping and/or adjusting travel or training schedules the following day.",2020,"Sleep onset time was significantly later following low, medium, and high summated heart-rate-zones game workloads, compared with control nights (P < .05).","['basketball players', 'Basketball Players', 'Seven semiprofessional male basketball players']",['sRPE game workloads'],"['Sleep measures', 'game workloads, sleep duration, and sleep quality', 'Sleep onset time', 'sleep duration and quality', 'Losing Sleep', 'Time in bed and sleep duration', 'heart-rate monitors, and rating of perceived exertion (RPE) and reported as PlayerLoad™ (PL), summated heart-rate zones, and session RPE (sRPE', 'subsequent sleep duration and sleep quality', 'Sleep duration and sleep quality']","[{'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0332282', 'cui_str': 'Following'}]",7.0,0.0237578,"Sleep onset time was significantly later following low, medium, and high summated heart-rate-zones game workloads, compared with control nights (P < .05).","[{'ForeName': 'Jordan L', 'Initials': 'JL', 'LastName': 'Fox', 'Affiliation': ''}, {'ForeName': 'Aaron T', 'Initials': 'AT', 'LastName': 'Scanlan', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stanton', 'Affiliation': ''}, {'ForeName': 'Cody J', 'Initials': 'CJ', 'LastName': ""O'Grady"", 'Affiliation': ''}, {'ForeName': 'Charli', 'Initials': 'C', 'LastName': 'Sargent', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0676']
2536,32814310,Metabolic Cost of Paddling on Different Commercially Available Kayak Ergometers.,"PURPOSE


To compare the metabolic cost of paddling on different commercially available kayak ergometers using a standardized kayak incremental exercise protocol.
METHODS


Six male sprint kayak athletes undertook an incremental exercise protocol on 3 different kayak ergometers utilizing a randomized counterbalanced pair-matched design.
RESULTS


Mean maximal aerobic power on the WEBA ergometer (265 [14] W) was significantly higher than on the Dansprint (238 [9] W) and KayakPro® (247 [21] W, P < .01, effect size [ES] = 0.80). At the fifth stage, absolute oxygen consumption on the WEBA (3.82 [0.25] L·min-1) was significantly lower (P < 0.05, ES = 0.20) than KayakPro and Dansprint (4.10 [0.28] and 4.08 [0.27] L·min-1, respectively). Blood lactate concentration response at the sixth stage was significantly lower for the WEBA (3.5 [0.8] mmol·L-1), compared with KayakPro and Dansprint (5.4 [1.2] and 5.6 [1.5] mmol·L-1, P = .012, ES = 0.20). Stroke rate was significantly higher, without any effect of pacing during the submaximal stages for the Dansprint, compared with the WEBA (P < .001, ES = 0.28) and KayakPro (P < .001, ES = 0.38). A pacing effect was present at the maximal stage for all ergometers.
CONCLUSIONS


This study demonstrated that paddling on different kayak ergometers when controlling power output elicits different metabolic and work outputs. It is recommended that scientists and coaches avoid testing on different ergometers and regularly calibrate these devices. Moreover, when an ergometer has been calibrated against a first principle device, it is necessary to consider calibration of various drag settings, due to their impact on stroke rate. Further research should explore the relationship between drag settings and stroke rate.",2020,"Mean maximal aerobic power on the WEBA ergometer (265 [14] W) was significantly higher than on the Dansprint (238 [9] W) and KayakPro® (247 [21] W, P < .01, effect size [ES] = 0.80).",['Six male sprint kayak athletes undertook an incremental exercise protocol on 3 different kayak ergometers utilizing a randomized counterbalanced pair-matched design'],[],"['Stroke rate', 'absolute oxygen consumption on the WEBA', 'Blood lactate concentration response', 'Mean maximal aerobic power on the WEBA ergometer', 'Metabolic Cost']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0336847', 'cui_str': 'Kayak'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]",[],"[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",6.0,0.0585615,"Mean maximal aerobic power on the WEBA ergometer (265 [14] W) was significantly higher than on the Dansprint (238 [9] W) and KayakPro® (247 [21] W, P < .01, effect size [ES] = 0.80).","[{'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Oliveira Borges', 'Affiliation': ''}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Bullock', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aitken', 'Affiliation': ''}, {'ForeName': 'Gregory R', 'Initials': 'GR', 'LastName': 'Cox', 'Affiliation': ''}, {'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Coutts', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0561']
2537,32811000,Multisystemic Treatment of Serious Behaviour Problems in Youth: Sustainability of Effectiveness Two Years after Intake.,"BACKGROUND


Multisystemic Treatment (MST) is an intensive home- and community based intervention for youths with serious behaviour problems. The aim of this study was to examine the effectiveness of MST compared to 'regular services' (RS) two years after intake to treatment. In particular, our goals were to investigate whether MST was successful at preventing placement out of home, and to examine reductions in behaviour problems in multi-informant assessments.
METHOD


Participants were 75 adolescents who were randomly assigned to MST or Regular Child Welfare Services (RS) at 3 sites across Norway. Data were gathered from youths, caregivers and teachers.
RESULTS


MST was more effective than RS in reducing out of home placement and behavioural problems.
DISCUSSION


The sustainability of treatment effects was evident, supporting the MST approach to the treatment of serious behavioural problems in youth. Site differences and the moderating effects of age and gender are discussed.",2006,"MST was more effective than RS in reducing out of home placement and behavioural problems.
","['Youth', 'youths with serious behaviour problems', 'Participants were 75 adolescents who were randomly assigned to MST or Regular Child Welfare Services (RS) at 3 sites across Norway']","['MST', 'Multisystemic Treatment (MST']",[],"[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0028423', 'cui_str': 'Norway'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}]",[],75.0,0.0250197,"MST was more effective than RS in reducing out of home placement and behavioural problems.
","[{'ForeName': 'Terje', 'Initials': 'T', 'LastName': 'Ogden', 'Affiliation': 'The Norwegian Centre for Studies of Conduct Problems and Innovative Practice, Unirand, PO Box 1565, Vika, N-0118 Oslo, Norway E-mail: terje.ogden@atferd.unirand.no.'}, {'ForeName': 'Kristine Amlund', 'Initials': 'KA', 'LastName': 'Hagen', 'Affiliation': 'The Norwegian Centre for Studies of Conduct Problems and Innovative Practice, Unirand, PO Box 1565, Vika, N-0118 Oslo, Norway E-mail: terje.ogden@atferd.unirand.no.'}]",Child and adolescent mental health,['10.1111/j.1475-3588.2006.00396.x']
2538,32811040,The Effect of an Education Program on Attitudes and Beliefs about Bullying and Bullying Behaviour in Junior Secondary School Students.,"This study assessed an intervention targeting bullying. Six schools were recruited, with 444 children aged between 12 and 15 years. Schools were randomly allocated to an intervention comprising education to students, parents and teachers about bullying and strategies believed to prevent bullying, or wait-list condition. Students reported bullying experiences on the Peer Relations Questionnaire and attitudes using the Attitude to Victim and Bully Scales, prior to the intervention and one year later. There was little difference between conditions on most measures. Short-term educational approaches appear to have little impact on bullying behaviour, and schools may need to develop alternative approaches.",2007,"Schools were randomly allocated to an intervention comprising education to students, parents and teachers about bullying and strategies believed to prevent bullying, or wait-list condition.","['Six schools were recruited, with 444 children aged between 12 and 15\u2003years', 'Junior Secondary School Students']","['Education Program', 'intervention comprising education to students, parents and teachers about bullying and strategies believed to prevent bullying, or wait-list condition']","['Attitudes and Beliefs about Bullying and Bullying Behaviour', 'Peer Relations Questionnaire and attitudes using the Attitude to Victim and Bully Scales']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0424318', 'cui_str': 'Bullying'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",444.0,0.0186296,"Schools were randomly allocated to an intervention comprising education to students, parents and teachers about bullying and strategies believed to prevent bullying, or wait-list condition.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hunt', 'Affiliation': 'School of Psychology, University of Sydney, New South Wales, 2006, Australia. E-mail: caroline@psych.usyd.edu.au.'}]",Child and adolescent mental health,['10.1111/j.1475-3588.2006.00417.x']
2539,32811042,Enhancing Adoptive Parenting: Devising Promising Interventions.,"After describing the common problems of children placed for adoption from local authority care and the views and concerns of adopters as recipients of services, the article describes two contrasting interventions designed to enhance new adopters' parenting skills and understanding. Aspects covered are the empirical and theoretical justifications for the interventions, the process of manualisation and the plan to evaluate the effectiveness of the interventions in a randomised controlled trial.",2006,"After describing the common problems of children placed for adoption from local authority care and the views and concerns of adopters as recipients of services, the article describes two contrasting interventions designed to enhance new adopters' parenting skills and understanding.",[],[],[],[],[],[],,0.0422993,"After describing the common problems of children placed for adoption from local authority care and the views and concerns of adopters as recipients of services, the article describes two contrasting interventions designed to enhance new adopters' parenting skills and understanding.","[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Rushton', 'Affiliation': ""Health Services Research Department, Institute of Psychiatry, King's College, London SE5 8AF, UK E-mail: a.rushton@iop.kcl.ac.uk.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Monck', 'Affiliation': 'Thomas Coram Research Unit, Institute of Education, University of London.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Upright', 'Affiliation': 'Clinical Psychologist with special responsibility for looked after children, Cambridgeshire.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Adoption Advisor, Surrey County Council.'}]",Child and adolescent mental health,['10.1111/j.1475-3588.2005.00371.x']
2540,32811056,Evidence Based Research in CBT with Adolescent Eating Disorders.,"Cognitive behaviour therapy (CBT) is increasingly becoming the treatment of choice for a number of adolescent mental health problems, including depression (Harrington et al., 1998) and obsessive compulsive disorder (OCD), (March, 1995). In considering the role of CBT in the treatment of adolescent eating disorders, it is helpful to review the phenomenology of anorexia and bulimia nervosa in this age group and to assess the theoretical relevance of a cognitive behavioural approach to their management. The evidence base has been reviewed in the recently published National Institute of Clinical Excellence (NICE) Guidelines on the treatment of eating disorders (NICE, 2004). To date, CBT approaches have not been widely tested in controlled trials in this age group. However, a randomised controlled treatment trial is under way in the North West of England (The TOuCAN Trial), in which CBT is an important component of one of the interventions being studied and this will be described.",2006,"Cognitive behaviour therapy (CBT) is increasingly becoming the treatment of choice for a number of adolescent mental health problems, including depression (Harrington et al., 1998) and obsessive compulsive disorder (OCD), (March, 1995).","['CBT with Adolescent Eating Disorders', 'adolescent eating disorders']","['CBT', 'Cognitive behaviour therapy (CBT']",[],"[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],,0.0323742,"Cognitive behaviour therapy (CBT) is increasingly becoming the treatment of choice for a number of adolescent mental health problems, including depression (Harrington et al., 1998) and obsessive compulsive disorder (OCD), (March, 1995).","[{'ForeName': 'Simon G', 'Initials': 'SG', 'LastName': 'Gowers', 'Affiliation': 'Department of Adolescent Psychiatry, University of Liverpool, 79 Liverpool Road, Chester CH2 1HW, UK. E-mail: simon.gowers@cwpnt.nhs.uk.'}]",Child and adolescent mental health,['10.1111/j.1475-3588.2005.00348.x']
2541,32811160,Parent utilization of ImPACT intervention strategies is a mediator of proximal then distal social communication outcomes in younger siblings of children with ASD.,"LAY ABSTRACT


Later born siblings of children with autism spectrum disorders (ASD) are at elevated risk for language delay or ASD. One way to manage this risk may be for parents to use techniques taught in  Im proving  P arents  a s  C ommunication  T eachers (ImPACT) with the younger siblings during the period in which language delay and ASD may be too subtle to be diagnosed. ImPACT targets children's play, imitation, and communication skills. Improvement in these skills may reduce the severity of language delays and social communication deficits associated with ASD. In this study, 97 younger siblings of children with ASD and their primary parents were randomly assigned to ImPACT or a control group. We measured whether parents used ImPACT teaching strategies and whether children used the skills that ImPACT targets. We also measured children's later language ability and social communication skills. The results confirmed our predictions that parents' use of ImPACT strategies improves language ability by improving children's motor imitation and communication skills. Use of ImPACT also had a positive effect on children's language delay and ASD symptoms, supporting the clinical value of the findings. The study's methodological strengths make this one of the most rigorous tests of ImPACT and supports one way to manage the risk of language delay and ASD in younger siblings of children with ASD.",2020,The results confirmed our predictions that parents' use of ImPACT strategies improves language ability by improving children's motor imitation and communication skills.,"['97 younger siblings of children with ASD and their primary parents', 'younger siblings of children with ASD', 'Later born siblings of children with autism spectrum disorders (ASD']",[],"[""children's language delay and ASD symptoms"", ""children's motor imitation and communication skills"", 'severity of language delays and social communication deficits', 'language ability', ""children's later language ability and social communication skills""]","[{'cui': 'C0337512', 'cui_str': 'Younger sibling'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}]",[],"[{'cui': 'C0008081', 'cui_str': 'Child Language'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0023012', 'cui_str': 'Language Delay'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205087', 'cui_str': 'Late'}]",97.0,0.0538178,The results confirmed our predictions that parents' use of ImPACT strategies improves language ability by improving children's motor imitation and communication skills.,"[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Yoder', 'Affiliation': 'Vanderbilt University, USA.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Stone', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Edmunds', 'Affiliation': 'Harvard Medical School, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361320946883']
2542,32811171,For which younger siblings of children with autism spectrum disorder does parent-mediated intervention work?,"LAY ABSTRACT


In this second of two primary papers, we examined two pre-intervention characteristics that might describe for whom a parent-implemented intervention, ""Improving Parents As Communication Teachers,"" worked. Investigators randomized 97 high-risk siblings and their primary parent to either the Improving Parents As Communication Teachers or control group, used intent-to-treat analysis, and used assessors and coders who were blinded to group assignment. We predicted that a combined risk score (incorporating young siblings' sex, multiplex status, and behavioral risk) would describe the subgroup for whom Improving Parents As Communication Teachers affected the targeted skills related to reducing communication challenges. We also predicted that pre-intervention level of parents' depressive symptoms would describe the parents whose parenting stress and effectiveness as parents would be improved by learning to use Improving Parents As Communication Teachers. In girls with only one older sibling with autism spectrum disorder and who scored at low risk on an autism spectrum disorder screen, parental receipt of Improving Parents As Communication Teachers training had an indirect effect on children's expressive language ability or autism spectrum disorder diagnosis through earlier effects on high-risk siblings' intentional communication or expressive vocabulary. We did not confirm our prediction regarding Improving Parents As Communication Teachers' effect on parenting-related stress or sense of parenting effectiveness.",2020,We did not confirm our prediction regarding Improving Parents,"['girls with only one older sibling with autism spectrum disorder and who scored at low risk on an autism spectrum disorder screen, parental receipt of Improving Parents']",[],"[""children's expressive language ability or autism spectrum disorder diagnosis"", 'parenting-related stress or sense of parenting effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0337511', 'cui_str': 'Older sibling'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",97.0,0.0282803,We did not confirm our prediction regarding Improving Parents,"[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Yoder', 'Affiliation': 'Vanderbilt University, USA.'}, {'ForeName': 'Wendy L', 'Initials': 'WL', 'LastName': 'Stone', 'Affiliation': 'University of Washington, USA.'}, {'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Edmunds', 'Affiliation': 'Harvard Medical School, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361320943373']
2543,32811175,Duration of contact lens removal before myopic refractive surgery.,"PURPOSE


To compare refractive surgery outcomes in patients with different periods without contact lenses prior laser surgery.
MATERIALS AND METHODS


Patients included in this study underwent myopic keratorefractive laser surgery between January 2005 and December 2014. Patients were divided into three groups based on the duration of time passed free of soft contact lens wearing prior to final preoperative evaluation and surgery (<24 h, 1-3 days or >3 days). Spectacle wearers served as a control group. Postoperative safety index, efficacy index and % of eyes within 0.5 D of the four groups were compared. A general linear model was used to compare main outcomes while adjusting for age, gender, preoperative measurements, and procedure type (LASIK vs PRK).
RESULTS


Overall, 19,747 eyes were included. Soft contact lenses were worn by 42.3% (<24 h: 4.8%, 1-3 days: 18.5% and >3 days: 19.0%) and spectacles by 57.7% prior to surgery. In the PRK group, after adjusting for differences in baseline variables, the <24-h group had a significantly lower efficacy index than all the other groups. There were no significant differences between groups in terms of % eyes within ±0.5 D of intended correction ( p  = 0.55) or safety index (0.20). In the LASIK group, after adjusting for differences in baseline variables, there were no significant differences between groups in all primary outcomes.
CONCLUSION


Soft contact lenses should be removed at least 24 h prior to final preoperative evaluation and refractive surgery, especially for patients undergoing PRK.",2020,"In the LASIK group, after adjusting for differences in baseline variables, there were no significant differences between groups in all primary outcomes.
","['19,747 eyes were included', 'patients undergoing PRK', 'Patients included in this study underwent myopic keratorefractive laser surgery between January 2005 and December 2014', 'patients with different periods without contact lenses prior laser surgery']",['soft contact lens wearing prior to final preoperative evaluation and surgery'],"['refractive surgery outcomes', 'safety index', 'Soft contact lenses', 'efficacy index', 'Postoperative safety index, efficacy index']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022772', 'cui_str': ""Democratic people's republic of Korea""}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0395416', 'cui_str': 'Refractive keratoplasty by laser surgery'}, {'cui': 'C0009836', 'cui_str': 'Contact lenses'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0023087', 'cui_str': 'Laser surgery'}]","[{'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1293091', 'cui_str': 'Pre-surgery evaluation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1274010', 'cui_str': 'Refractive surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0009838', 'cui_str': 'Hydrophilic contact lens'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",19747.0,0.0317946,"In the LASIK group, after adjusting for differences in baseline variables, there were no significant differences between groups in all primary outcomes.
","[{'ForeName': 'Raneen', 'Initials': 'R', 'LastName': 'Shehadeh-Mashor', 'Affiliation': 'Department of Ophthalmology, The Baruch Padeh Medical Center, Poriya, Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mimouni', 'Affiliation': 'Department of Ophthalmology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Yinon', 'Initials': 'Y', 'LastName': 'Shapira', 'Affiliation': 'Department of Ophthalmology, Rambam Health Care Campus, Haifa, Israel.'}, {'ForeName': 'Tzahi', 'Initials': 'T', 'LastName': 'Sela', 'Affiliation': 'Care-Vision Laser Centers, Tel-Aviv, Israel.'}, {'ForeName': 'Gur', 'Initials': 'G', 'LastName': 'Munzer', 'Affiliation': 'Care-Vision Laser Centers, Tel-Aviv, Israel.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Kaiserman', 'Affiliation': 'Care-Vision Laser Centers, Tel-Aviv, Israel.'}]",European journal of ophthalmology,['10.1177/1120672120949101']
2544,32811186,Comparison of electroacupuncture and manual acupuncture for patients with plantar heel pain syndrome: a randomized controlled trial.,"BACKGROUND


Plantar heel pain syndrome (PHPS), also known as plantar fasciitis, affects millions of people worldwide. Electroacupuncture (EA) and manual acupuncture (MA) are the two acupuncture modalities frequently used for PHPS in the clinical setting. However, which modality is more effective has yet to be determined.
OBJECTIVE


To examine whether EA is more effective than MA with regards to pain relief for patients with PHPS.
METHODS


Participants were randomly assigned (1:1) to receive 12 treatment sessions of EA or MA over 4 weeks with 24 weeks of follow-up. The primary outcome was the proportion of treatment responders, defined as patients with at least a 50% reduction from baseline in the worst pain intensity experienced during the first steps in the morning after a 4-week treatment, measured using a visual analogue scale (VAS, 0-100; higher scores signify worse pain). Analysis was by intention-to-treat.
RESULTS


Ninety-two patients with a clinical diagnosis of PHPS were enrolled from 29 July 2018 through 28 June 2019. Of the patients, 78 (85%) completed the treatment and follow-up. The primary outcome occurred in 54.8% (23/42) of the EA group compared to 50.0% (21/42) of the MA group after the 4-week treatment (difference -4.76, 95% confidence interval, -26.10 to 16.57,  P  = 0.662). There were no significant between-group differences for any secondary outcomes after 4 weeks of treatment and at 16 weeks and 28 weeks of follow-up. There were no serious treatment-related adverse events in either group.
CONCLUSION


Among patients with PHPS, EA did not have a better effect with respect to relieving pain intensity than MA at week 4, although both EA and MA appeared to have positive temporal effects, with decreased heel pain and improved plantar function.
TRIAL REGISTRATION NUMBER


ChiCTR1800016531 (Chinese Clinical Trial Registry).",2020,There were no significant between-group differences for any secondary outcomes after 4 weeks of treatment and at 16 weeks and 28 weeks of follow-up.,"['patients with plantar heel pain syndrome', 'patients with PHPS', 'Ninety-two patients with a clinical diagnosis of PHPS were enrolled from 29 July 2018 through 28 June 2019', 'Participants', 'Plantar heel pain syndrome (PHPS']","['EA', 'Electroacupuncture (EA) and manual acupuncture (MA', 'electroacupuncture and manual acupuncture', 'EA or MA']","['proportion of treatment responders', 'pain relief', 'serious treatment-related adverse events', 'visual analogue scale', 'worst pain intensity', 'heel pain and improved plantar function', 'relieving pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231786', 'cui_str': 'Plantar heel pain'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231780', 'cui_str': 'Heel pain'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",92.0,0.247168,There were no significant between-group differences for any secondary outcomes after 4 weeks of treatment and at 16 weeks and 28 weeks of follow-up.,"[{'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ""Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Key Laboratory of Chinese Internal Medicine of Ministry of Education, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ruimin', 'Initials': 'R', 'LastName': 'Jiao', 'Affiliation': ""Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Sixing', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Guizhou University of Traditional Chinese Medicine, Guiyang, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': ""Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}, {'ForeName': 'Zhishun', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.""}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420947739']
2545,32811236,To compare the optimal cytoreduction rate in advanced epithelial ovarian cancer stage III/IV after 3 versus 6 cycles of neoadjuvant chemotherapy.,"This study aimed to compare the impact of 3 versus 6 cycles of neoadjuvant chemotherapy (NACT) on the optimal cytoreduction in patients of advanced ovarian malignancy during interval debulking surgery (IDS). Thirty patients with advanced-stage IIIc/IV epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer were randomly allocated to receive 6 cycles in the late IDS group versus 3 cycles in early IDS before undergoing interval debulking surgery. A higher percentage of patients achieved optimal cytoreduction in the late IDS group compared to the early IDS group (60 versus 23%) which was statistically significant ( p  = .010). Giving 6 cycles of NACT before surgery increased the odd of optimal cytoreduction by 10 than giving 3 cycles of NACT which was statistically significant ( p  = 0.046) Thus, we conclude that administering 6 cycles of neoadjuvant chemotherapy before debulking surgery helps in achieving optimal cytoreduction in a higher number of patients with lesser surgical morbidity. IMPACT STATEMENT  What is already known on the subject?  Currently, there are no established criteria that would help to determine the number of chemotherapy cycles before debulking surgery in patients with advanced ovarian malignancy.  What do the results of this study add?  Administering 6 cycles of neoadjuvant chemotherapy before debulking surgery helps in achieving optimal cytoreduction in a higher number of patients with lesser surgical morbidity in cases of advanced epithelial ovarian cancer.  What are the implications of these findings for clinical practice and/or further research?  We conclude that late interval debulking may be used as a treatment option in the advanced stage IIIc/stage IV. However, the findings need to be studied in a larger study group with a longer follow up period.",2020,Giving 6 cycles of NACT before surgery increased the odd of optimal cytoreduction by 10 than giving 3 cycles of NACT which was statistically significant ( p  = 0.046),"['patients with advanced ovarian malignancy', 'Thirty patients with advanced-stage IIIc/IV epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer', 'patients of advanced ovarian malignancy during interval debulking surgery (IDS']","['late IDS group versus 3 cycles in early IDS before undergoing interval debulking surgery', 'NACT', 'neoadjuvant chemotherapy', 'neoadjuvant chemotherapy (NACT']","['surgical morbidity', 'optimal cytoreduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0153579', 'cui_str': 'Malignant tumor of fallopian tube'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive surgery'}]",30.0,0.0852935,Giving 6 cycles of NACT before surgery increased the odd of optimal cytoreduction by 10 than giving 3 cycles of NACT which was statistically significant ( p  = 0.046),"[{'ForeName': 'Archana', 'Initials': 'A', 'LastName': 'Kumari', 'Affiliation': 'Department of Obstetrics & Gynaecology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Thakur', 'Affiliation': 'Department of Obstetrics & Gynaecology, Dr. Yashwant Singh Parmar Government Medical College, Nahan, India.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Saha', 'Affiliation': 'Department of Obstetrics & Gynaecology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Suri', 'Affiliation': 'Department of Obstetrics & Gynaecology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'G R V', 'Initials': 'GRV', 'LastName': 'Prasad', 'Affiliation': 'Department of Obstetrics & Gynaecology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Firuza D', 'Initials': 'FD', 'LastName': 'Patel', 'Affiliation': 'Department of Radiotherapy, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Radhika', 'Affiliation': 'Department of Cytology, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology,['10.1080/01443615.2020.1787967']
2546,32811272,No panacea? Tai Chi enhances motoric but not executive functioning in a normal aging population.,"Tai Chi Chuan (TCC) is a promising intervention against age-related decline. Though previous studies have shown benefits in motoric and cognitive domains, it is unclear how these effects are functionally related. Therefore, a randomized controlled trial was conducted in an aging population (53-85). Two measures of motor functioning - motor speed and functional balance - and three cognitive control measures - shifting, updating and inhibition - were included. The TCC condition consisted of an online 10 week 20 lessons video program of increasing level and control condition of educational videos of similar length and frequency. All analyses were done with Bayesian statistics. Counter to expectation no differences were found in cognition between TCC and control pre-to-posttest. However, there was extreme evidence for TCC benefits on functional balance and moderate evidence for increased motoric speed. After weighing the evidence and limitations of the intervention we conclude that TCC does not enhance cognitive control.",2020,Counter to expectation no differences were found in cognition between TCC and control pre-to-posttest.,['aging population (53-85'],"['Tai Chi enhances motoric', 'TCC', 'Tai Chi Chuan (TCC']","['motor functioning\xa0- motor speed and functional balance\xa0- and three cognitive control measures\xa0- shifting, updating and inhibition ']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0376403', 'cui_str': 'Tai-chi'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",,0.0943107,Counter to expectation no differences were found in cognition between TCC and control pre-to-posttest.,"[{'ForeName': 'Roderik J S', 'Initials': 'RJS', 'LastName': 'Gerritsen', 'Affiliation': 'Cognitive Psychology, Institute of Psychology, Leiden University , Leiden, The Netherlands.'}, {'ForeName': 'Joëlle', 'Initials': 'J', 'LastName': 'Lafeber', 'Affiliation': 'Cognitive Psychology, Institute of Psychology, Leiden University , Leiden, The Netherlands.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'van den Beukel', 'Affiliation': 'Cognitive Psychology, Institute of Psychology, Leiden University , Leiden, The Netherlands.'}, {'ForeName': 'Guido P H', 'Initials': 'GPH', 'LastName': 'Band', 'Affiliation': 'Cognitive Psychology, Institute of Psychology, Leiden University , Leiden, The Netherlands.'}]","Neuropsychology, development, and cognition. Section B, Aging, neuropsychology and cognition",['10.1080/13825585.2020.1809629']
2547,32811342,Treatment of subclinical hyperthyroidism in the elderly: Comparison of radioiodine and long-term methimazole treatment.,"BACKGROUND


This study aimed to compare the effectiveness and safety of radioiodine (RAI) and long-term methimazole (MMI) in the treatment of subclinical hyperthyroidism in the elderly.
METHODS


From 306 patients, aged ≥ 65 years, with subclinical hyperthyroidism, 83 patients with TSH<0.1 mU/L entered the study. In this randomized, parallel-group trial, 41 and 42 patients were randomized to either RAI or long-term MMI treatment, respectively.
RESULTS


In the RAI and MMI groups, 3 and 4 patients were excluded due to side effects, choosing other modes of treatment and not returning for follow-up; 35 and 36 patients completed 60 months of follow-up, respectively. In the RAI group, 23 (66%) became hypothyroid, and 12 (34%) remained euthyroid 60 months after a fixed dose of 15 mCi RAI. In the MMI group, the starting dose was 10 mg daily and decreased to 4.9±1.0, 4.3±1.0, 4.4±1.4, 4.3±1.8 and 3.7±1.3 mg after one, two, three, four and five years of continuous MMI treatment, employing titration method. By the end of study, 34 (94%) patients were euthyroid and 2 patients with diffuse goiter developed spontaneous hypothyroidism with MMI treatment. Minor adverse events occurred in both groups in the first four months of treatment. No death or serious side effects were observed during 60 months of follow-up.
CONCLUSIONS


Both RAI and long-term low dose MMI therapies are effective and safe for treatment of subclinical hyperthyroidism in the elderly.",2020,"No death or serious side effects were observed during 60 months of follow-up.
","['From 306 patients, aged ≥ 65 years, with subclinical hyperthyroidism', 'subclinical hyperthyroidism in the elderly', '41 and 42 patients', '83 patients with TSH<0.1 mU/L entered the study']","['RAI or long-term MMI', 'radioiodine (RAI) and long-term methimazole (MMI', 'radioiodine']","['spontaneous hypothyroidism', 'No death or serious side effects', 'Minor adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1998045', 'cui_str': 'Subclinical hyperthyroidism'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439342', 'cui_str': 'mU/L'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C2828294', 'cui_str': 'iodide ion I-131'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0025644', 'cui_str': 'Methimazole'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",83.0,0.0386865,"No death or serious side effects were observed during 60 months of follow-up.
","[{'ForeName': 'Fereidoun', 'Initials': 'F', 'LastName': 'Azizi', 'Affiliation': 'Research Institute for Endocrine Sciences, 216627, Endocrine Research Center, Tehran, Tehran, Iran (the Islamic Republic of); azizi@endocrine.ac.ir.'}, {'ForeName': 'Hengameh', 'Initials': 'H', 'LastName': 'Abdi', 'Affiliation': 'Research Institute for Endocrine Sciences, 216627, Endocrine Research Center, Tehran, Tehran, Iran (the Islamic Republic of); abdi@endocrine.ac.ir.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Cheraghi', 'Affiliation': 'Research Institute for Endocrine Sciences, 216627, Tehran, Tehran, Iran (the Islamic Republic of); Leila_cheraghi63@yahoo.com.'}, {'ForeName': 'Atieh', 'Initials': 'A', 'LastName': 'Amouzegar', 'Affiliation': 'Research Institute for Endocrine Sciences, 216627, Endocrine Research Center, Tehran, Tehran, Iran (the Islamic Republic of); amouzegar@endocrine.ac.ir.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2020.0433']
2548,32811378,Higher Doses Improve Walking Recovery During Stroke Inpatient Rehabilitation.,"BACKGROUND AND PURPOSE


We investigated the effect of higher therapeutic exercise doses on walking during inpatient rehabilitation, typically commencing 1 to 4 weeks poststroke.
METHODS


This phase II, blinded-assessor, randomized controlled trial recruited from 6 Canadian inpatient rehabilitation units, between 2014 and 2018. Subjects (n=75; 25/group) were randomized into: control (usual care) physical therapy: typically, 1 hour, 5 days/week; Determining Optimal Post-Stroke Exercise (DOSE1): 1 hour, 5 days/week, more than double the intensity of Control (based on aerobic minutes and walking steps); and DOSE2: 2 hours, 5 days/week, more than quadruple the intensity of Control, each for 4 weeks duration. The primary outcome, walking endurance at completion of the 4-week intervention (post-evaluation), was compared across these groups using linear regression. Secondary outcomes at post-evaluation, and longitudinal outcomes at 6 and 12-month evaluations, were also analyzed.
RESULTS


Both DOSE1 (mean change 61 m [95% CI, 9-113],  P =0.02) and DOSE2 (mean change 58 m, 6-110,  P =0.03) demonstrated greater walking endurance compared with Control at the post-evaluation. Significant improvements were also observed with DOSE2 in gait speed (5-m walk), and both DOSE groups in quality of life (EQ-5D-5 L) compared with Control. Longitudinal analyses revealed that improvements in walking endurance from the DOSE intervention were retained during the 1-year follow-up period over usual care.
CONCLUSIONS


This study provides the first preliminary evidence that patients with stroke can improve their walking recovery and quality of life with higher doses of aerobic and stepping activity within a critical time period for neurological recovery. Furthermore, walking endurance benefits achieved from a 4-week intervention are retained over the first-year poststroke.
REGISTRATION


URL: https://www.clinicaltrials.gov. Unique identifier: NCT01915368.",2020,"Significant improvements were also observed with DOSE2 in gait speed (5-m walk), and both DOSE groups in quality of life (EQ-5D-5 L) compared with Control.","['Subjects (n=75; 25/group', '6 Canadian inpatient rehabilitation units, between 2014 and 2018', 'patients with stroke']","['control (usual care) physical therapy', 'DOSE1']","['DOSE2 in gait speed (5-m walk', 'Walking Recovery', 'quality of life (EQ-5D-5 L', 'DOSE2', 'walking endurance at completion of the 4-week intervention (post-evaluation', 'walking endurance benefits', 'walking endurance']","[{'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",,0.0592141,"Significant improvements were also observed with DOSE2 in gait speed (5-m walk), and both DOSE groups in quality of life (EQ-5D-5 L) compared with Control.","[{'ForeName': 'Tara D', 'Initials': 'TD', 'LastName': 'Klassen', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, Canada. (T.D.K., T.L.-A., A.S., J.J.E.).'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Dukelow', 'Affiliation': 'Department of Clinical Neurosciences, Hotchkiss Brain Institute, University of Calgary, Canada. (S.P.D., M.D.H.).'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Bayley', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Toronto, Canada (M.T.B.).'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Benavente', 'Affiliation': 'Division of Neurology, University of British Columbia, Vancouver, Canada. (O.B.).'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Neurosciences, Hotchkiss Brain Institute, University of Calgary, Canada. (S.P.D., M.D.H.).'}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Krassioukov', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, Canada. (A.K., J.Y.).'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Liu-Ambrose', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, Canada. (T.D.K., T.L.-A., A.S., J.J.E.).'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Pooyania', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of Manitoba (S.P.).'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Poulin', 'Affiliation': 'Department of Physiology & Pharmacology, University of Calgary, Canada. (M.J.P.).'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Schneeberg', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, Canada. (T.D.K., T.L.-A., A.S., J.J.E.).'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, University of British Columbia, Vancouver, Canada. (A.K., J.Y.).'}, {'ForeName': 'Janice J', 'Initials': 'JJ', 'LastName': 'Eng', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, Canada. (T.D.K., T.L.-A., A.S., J.J.E.).'}]",Stroke,['10.1161/STROKEAHA.120.029245']
2549,32811427,"Efficacy of a high-dose proton pump inhibitor in patients with gastroesophageal reflux disease: a single center, randomized, open-label trial.","BACKGROUND


The extraesophageal manifestations of gastroesophageal reflux disease (GERD) are more difficult to manage than the typical symptoms. The efficacy of high-dose and standard-dose proton pump inhibitors against these atypical symptoms is not yet established.
METHODS


In this single center, randomized, open-label study, patients with GERD received rabeprazole for 8 weeks, either 20 mg once daily (standard-dose group) or 20 mg twice daily (high-dose group). Patients were assessed before treatment and at weeks 4 and 8 with a 5-graded scale questionnaire consisting of 2 typical symptoms (heartburn and acid regurgitation) and 8 atypical symptoms (chest pain, cough, globus, wheezing, laryngopharyngitis, hoarseness, belching, and dysphagia). Sufficient improvement of reflux symptoms was defined as ≥50% reduction from the initial questionnaire score.
RESULTS


Final analyses included 35 patients in the standard-dose group and 38 patients in the high-dose group. The rate of sufficient improvement for typical symptoms was significantly higher in the high-dose group than in the standard-dose group (100.0% vs. 84.0%, P = 0.040). For atypical symptoms, the rate of sufficient improvement tended to be higher in the high-dose group than in the standard-dose group (82.4% vs. 63.0%, P = 0.087). Scores of typical and some atypical symptoms (cough and globus) improved after treatment, with significant inter-group differences in time-course changes.
CONCLUSIONS


High-dose rabeprazole is more effective for relieving typical GERD symptoms and some atypical symptoms such as cough and globus than a standard-dose regimen.
TRIAL REGISTRATION


This research was enrolled in a registry of clinical trials run by United States National Library of Medicine at the National Institutes of Health ( ClinicalTrials.gov Protocol Registration and Results system ID: NCT04001400 ). This study was registered on June 26, 2019 - Retrospectively registered.",2020,"Scores of typical and some atypical symptoms (cough and globus) improved after treatment, with significant inter-group differences in time-course changes.
","['June 26, 2019 - Retrospectively registered', 'patients with gastroesophageal reflux disease']","['high-dose proton pump inhibitor', 'rabeprazole']","['rate of sufficient improvement for typical symptoms', 'time-course changes', 'reflux symptoms', 'Scores of typical and some atypical symptoms (cough and globus', '5-graded scale questionnaire consisting of 2 typical symptoms (heartburn and acid regurgitation) and 8 atypical symptoms (chest pain, cough, globus, wheezing, laryngopharyngitis, hoarseness, belching, and dysphagia']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}]","[{'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205182', 'cui_str': 'Atypical'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0023070', 'cui_str': 'Pharyngolaryngitis'}, {'cui': 'C0019825', 'cui_str': 'Hoarse'}, {'cui': 'C0014724', 'cui_str': 'Eructation'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]",,0.059352,"Scores of typical and some atypical symptoms (cough and globus) improved after treatment, with significant inter-group differences in time-course changes.
","[{'ForeName': 'Jae Ho', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, South Korea.'}, {'ForeName': 'Cheol Min', 'Initials': 'CM', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, South Korea.'}, {'ForeName': 'Hyuk', 'Initials': 'H', 'LastName': 'Yoon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, South Korea.'}, {'ForeName': 'Young Soo', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, South Korea.'}, {'ForeName': 'Nayoung', 'Initials': 'N', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, South Korea.'}, {'ForeName': 'Dong Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 13620, South Korea. dhljohn@yahoo.co.kr.'}]",BMC gastroenterology,['10.1186/s12876-020-01410-z']
2550,32811448,Functional training added to intradialytic cycling lowers low-density lipoprotein cholesterol and improves dialysis adequacy: a randomized controlled trial.,"BACKGROUND


Exercise has various positive effects on hemodialysis patients. However, there is no clear evidence which type of exercise yields better results. This study aimed to determine the effects of guided functional training added to the intradialytic cycling on dialysis adequacy and biochemical parameters in hemodialysis patients. Additionally, we aimed to investigate if patients could transfer functional exercise to an unsupervised home environment and retain gained improvements.
METHODS


Randomization was done to a functional training intervention group (INT) (n = 20) or intradialytic cycling control group (CON) (n = 20). The INT attended a pre-dialysis functional training in the first 8 weeks. In the second 8 weeks, they performed functional exercises at unsupervised home environment on non-dialysis days. During the whole study, both groups participated in the intradialytic cycling program.
RESULTS


Both groups demonstrated a significant increase in dialysis adequacy (Kt/V) in the eight (0.15, 95% CI 0.06 to 0.24; p = 0.003 for INT and 0.21, 95% CI 0.11 to 0.3; p < 0.001 for CON) and the 16th study week (0.13, 95% CI 0.03 to 0.24; p = 0.017 for INT and 0.13, 95% CI 0.03 to 0.22; p = 0.013 for CON) compared to their baseline values with no significant between-group differences. At week eight, the total cholesterol was significantly lowered in the INT (- 0.34 mmol/L, 95% CI - 0.6 to - 0.07; p = 0.016) and remained lower at week 16 (- 0.32 mmol/L, 95% CI - 0.64 to - 0.01; p = 0.049) with no significant changes in the CON. Low-density lipoprotein levels in the INT were significantly reduced after 8 weeks (- 0.35 mmol/L, 95% CI - 0.64 to - 0.06; p = 0.022) and remained reduced after 16 weeks (- 0.28 mmol/L, 95% CI - 0.52 to - 0.03; p = 0.030). There were no significant differences found for albumin, high-density lipoprotein cholesterol, triglycerides, C-reactive protein, and hemoglobin in both groups.
CONCLUSIONS


We demonstrated that functional training added to intradialytic cycling improved lipid profile and dialysis adequacy. Additionally, the effects of the unsupervised, home-based program were preserved during the second study phase. This study supports the assumption that combined training is more effective compared to solely intradialytic exercise.
TRIAL REGISTRATION


ClinicalTrials.Gov, NCT03334123 . Registered 07 November 2017.",2020,"Low-density lipoprotein levels in the INT were significantly reduced after 8 weeks (- 0.35 mmol/L, 95% CI - 0.64 to - 0.06; p = 0.022) and remained reduced after 16 weeks (- 0.28 mmol/L, 95% CI - 0.52 to - 0.03; p = 0.030).",['hemodialysis patients'],"['guided functional training', 'functional training', 'functional training intervention group (INT) (n\u2009=\u200920) or intradialytic cycling control group (CON', 'Functional training added to intradialytic cycling']","['lipid profile and dialysis adequacy', 'Low-density lipoprotein levels', 'total cholesterol', 'dialysis adequacy', 'albumin, high-density lipoprotein cholesterol, triglycerides, C-reactive protein, and hemoglobin']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0712668,"Low-density lipoprotein levels in the INT were significantly reduced after 8 weeks (- 0.35 mmol/L, 95% CI - 0.64 to - 0.06; p = 0.022) and remained reduced after 16 weeks (- 0.28 mmol/L, 95% CI - 0.52 to - 0.03; p = 0.030).","[{'ForeName': 'Špela', 'Initials': 'Š', 'LastName': 'Bogataj', 'Affiliation': 'Department of Nephrology, University Medical Centre, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Jernej', 'Initials': 'J', 'LastName': 'Pajek', 'Affiliation': 'Department of Nephrology, University Medical Centre, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Jadranka', 'Initials': 'J', 'LastName': 'Buturović Ponikvar', 'Affiliation': 'Department of Nephrology, University Medical Centre, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Pajek', 'Affiliation': 'University of Ljubljana, Faculty of Sport, 1000, Ljubljana, Slovenia. maja.pajek@fsp.uni-lj.si.'}]",BMC nephrology,['10.1186/s12882-020-02021-2']
2551,32811527,Periacetabular osteotomy with or without arthroscopic management in patients with hip dysplasia: study protocol for a multicenter randomized controlled trial.,"BACKGROUND


Hip dysplasia is one of the most common causes of hip arthritis. Its incidence is estimated to be between 3.6 and 12.8% (Canadian Institute for Health Information, Hip and knee replacements in Canada, 2017-2018: Canadian joint replacement registry annual report, 2019; Jacobsen and Sonne-Holm, Rheumatology 44:211-8, 2004). The Periacetabular Osteotomy (PAO) has been used successfully for over 30 years (Gosvig et al., J Bone Joint Surg Am 92:1162-9, 2010), but some patients continue to exhibit symptoms post-surgery (Wyles et al., Clin Orthop Relat Res 475:336-50, 2017). A hip arthroscopy, performed using a small camera, allows surgeons to address torn cartilage inside the hip joint. Although both procedures are considered standard of care treatment options, it is unknown whether the addition of hip arthroscopy improves patient outcomes compared to a PAO alone. To delay or prevent future joint replacement surgeries, joint preservation surgery is recommended for eligible patients. While previous studies found an added cost to perform hip arthroscopies, the cost-effectiveness to Canadian Health care system is not known.
METHODS


Patients randomized to the experimental group will undergo central compartment hip arthroscopy prior to completion of the PAO. Patients randomized to the control group will undergo isolated PAO. Patient-reported quality of life will be the primary outcome used for comparison between the two treatment groups as measured by The International Hip Outcome Tool (iHOT-33) (Saberi Hosnijeh et al., Arthritis Rheum 69:86-93, 2017). Secondary outcomes will include the four-square step test and sit-to-stand (validated in patients with pre-arthritic hip pain) and hip-specific symptoms and impairment using the HOOS; global health assessment will be compared using the PROMIS Global 10 Score; health status will be assessed using the EQ-5D-5L and EQ VAS questionnaires (Ganz et al., Clin Orthop Relat Res 466:264-72, 2008) pre- and post-operatively. In addition, operative time, hospital length of stay, adverse events, and health services utilization will be collected. A sub-group of patients (26 in each group) will receive a T1rho MRI before and after surgery to study changes in cartilage quality over time. A cost-utility analysis will be performed to compare costs and quality-adjusted life years (QALYs) associated with the intervention.
DISCUSSION


We hypothesize that (1) concomitant hip arthroscopy at the time of PAO to address central compartment pathology will result in clinically important improvements in patient-reported outcome measures (PROMs) versus PAO alone, that (2) additional costs associated with hip arthroscopy will be offset by greater clinical improvements in this group, and that (3) combined hip arthroscopy and PAO will prove to be a cost-effective procedure.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03481010 . Registered on 6 March 2020. Protocol version: version 3.",2020,"A hip arthroscopy, performed using a small camera, allows surgeons to address torn cartilage inside the hip joint.","['eligible patients', 'patients with hip dysplasia']","['central compartment hip arthroscopy prior to completion of the PAO', 'Periacetabular osteotomy with or without arthroscopic management', 'Periacetabular Osteotomy (PAO', 'control group will undergo isolated PAO']","['quality of life', 'EQ-5D-5L and EQ VAS questionnaires', 'costs and quality-adjusted life years (QALYs', 'operative time, hospital length of stay, adverse events, and health services utilization', 'four-square step test and sit-to-stand (validated in patients with pre-arthritic hip pain) and hip-specific symptoms and impairment using the HOOS; global health assessment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1328407', 'cui_str': 'Hip Dysplasia'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0186190', 'cui_str': 'Diagnostic arthroscopy of hip joint'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.130164,"A hip arthroscopy, performed using a small camera, allows surgeons to address torn cartilage inside the hip joint.","[{'ForeName': 'Geoffrey P', 'Initials': 'GP', 'LastName': 'Wilkin', 'Affiliation': 'Division of Orthopaedic Surgery, The Ottawa Hospital, General Campus, 501 Smyth Road, Ottawa, ON, K1H 8L6, Canada.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Poitras', 'Affiliation': 'School of Rehabilitation, University of Ottawa, 451 Smyth Road, Ottawa, ON, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Clohisy', 'Affiliation': 'Division of Orthopaedic Surgery, Washington University School of Medicine, 660 S Euclid Ave, St. Louis, MO, USA.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Belzile', 'Affiliation': ""Division of Orthopaedic Surgery, Centre hospitalier de l'Université Laval, Québec, QC, Canada.""}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Zaltz', 'Affiliation': 'Division of Orthopaedic Surgery, William Beaumont Hospital (Troy Michigan), Royal Oak, MI, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Grammatopoulos', 'Affiliation': 'Division of Orthopaedic Surgery, The Ottawa Hospital, General Campus, 501 Smyth Road, Ottawa, ON, K1H 8L6, Canada.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Melkus', 'Affiliation': 'Division of Orthopaedic Surgery, The Ottawa Hospital, General Campus, 501 Smyth Road, Ottawa, ON, K1H 8L6, Canada.'}, {'ForeName': 'Kawan', 'Initials': 'K', 'LastName': 'Rakhra', 'Affiliation': 'Division of Orthopaedic Surgery, The Ottawa Hospital, General Campus, 501 Smyth Road, Ottawa, ON, K1H 8L6, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ramsay', 'Affiliation': 'Department of Clinical Epidemiology, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, Canada.'}, {'ForeName': 'Kednapa', 'Initials': 'K', 'LastName': 'Thavorn', 'Affiliation': 'Department of Clinical Epidemiology, Ottawa Hospital Research Institute, 501 Smyth Road, Ottawa, ON, Canada.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Beaulé', 'Affiliation': 'Division of Orthopaedic Surgery, The Ottawa Hospital, General Campus, 501 Smyth Road, Ottawa, ON, K1H 8L6, Canada. pbeaule@toh.ca.'}]",Trials,['10.1186/s13063-020-04592-9']
2552,32811531,Treatment of severe COVID-19 with human umbilical cord mesenchymal stem cells.,"BACKGROUND


COVID-19 is a highly infectious respiratory disease. No therapeutics have yet been proven effective for treating severe COVID-19.
OBJECTIVES


To determine whether human umbilical cord mesenchymal stem cell infusion may be effective and safe for the treatment of severe COVID-19.
METHODS


Patients with severe COVID-19 were randomly divided into 2 groups: the standard treatment group and the standard treatment plus hUC-MSC infusion group. The incidence of progression from severe to critical illness, 28-day mortality, clinical symptom improvement, time to clinical symptom improvement, hematologic indicators including C-reactive protein, lymphocyte number, and interleukin 6, and imaging changes were observed and compared between the two groups.
MEASUREMENTS AND MAIN RESULTS


The incidence of progression from severe to critical illness and the 28-day mortality rate were 0 in the hUC-MSC treatment group, while 4 patients in the control group deteriorated to critical condition and received invasive ventilation; 3 of them died, and the 28-day mortality rate was 10.34%. In the hUC-MSC treatment group, the time to clinical improvement was shorter than that in the control group. Clinical symptoms of weakness and fatigue, shortness of breath, and low oxygen saturation obviously improved beginning on the third day of stem cell infusion and reached a significant difference on day 7. CRP and IL-6 levels were significantly lower from day 3 of infusion, the time for the lymphocyte count to return to the normal range was significantly faster, and lung inflammation absorption was significantly shorter on CT imaging in the hUC-MSC group than in the control group.
CONCLUSIONS


Intravenous transplantation of hUC-MSCs is a safe and effective method that can be considered a salvage and priority treatment option for severe COVID-19.
TRIAL REGISTRATION


Chinese Clinical Trial Registration; ChiCTR2000031494; Registered on 2 April 2020; http:// www.medresman.org.",2020,"CRP and IL-6 levels were significantly lower from day 3 of infusion, the time for the lymphocyte count to return to the normal range was significantly faster, and lung inflammation absorption was significantly shorter on CT imaging in the hUC-MSC group than in the control group.
","['severe COVID-19 with human umbilical cord mesenchymal stem cells', 'Patients with severe COVID-19']","['hUC-MSC', 'human umbilical cord mesenchymal stem cell infusion', 'standard treatment group and the standard treatment plus hUC-MSC infusion group']","['time to clinical improvement', 'incidence of progression from severe to critical illness, 28-day mortality, clinical symptom improvement, time to clinical symptom improvement, hematologic indicators including C-reactive protein, lymphocyte number, and interleukin 6, and imaging changes', 'Clinical symptoms of weakness and fatigue, shortness of breath, and low oxygen saturation', 'lung inflammation absorption', '28-day mortality rate', 'CRP and IL-6 levels']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0074299', 'cui_str': 'selenomethylselenocysteine'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0200635', 'cui_str': 'Lymphocyte count'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.062267,"CRP and IL-6 levels were significantly lower from day 3 of infusion, the time for the lymphocyte count to return to the normal range was significantly faster, and lung inflammation absorption was significantly shorter on CT imaging in the hUC-MSC group than in the control group.
","[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shu', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Niu', 'Affiliation': 'Department of Critical Care Medicine, the Second Affiliated Hospital of Nanjing Medical University, Nanjing, 210011, Jiangsu, China.'}, {'ForeName': 'Ruyou', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory Medicine, Huangshi Central Hospital, Hangshi, 435000, Hubei, China.'}, {'ForeName': 'Tingrong', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Department of Nephrology, Huangshi Hospital of Traditional Chinese Medicine, Hangshi, 435000, Hubei, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Cell Tech Medical Research Institute, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, the First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Ningfei', 'Initials': 'N', 'LastName': 'Ji', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, the First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Nephrology, Huangshi Hospital of Traditional Chinese Medicine, Hangshi, 435000, Hubei, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Mingjing', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Kaili', 'Initials': 'K', 'LastName': 'Deng', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': 'Department of Respiratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing, 211166, Jiangsu, China.'}, {'ForeName': 'Ganzhu', 'Initials': 'G', 'LastName': 'Feng', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, the Second Affiliated Hospital of Nanjing Medical University, Address: No. 121 Jiangjiayuan Rd, Gulou District, Nanjing, 210011, Jiangsu, China. fenggz163@163.com.'}]",Stem cell research & therapy,['10.1186/s13287-020-01875-5']
2553,32811539,"Substitution of perioperative albumin deficiency disorders (SuperAdd) in adults undergoing vascular, abdominal, trauma, or orthopedic surgery: protocol for a randomized controlled trial.","BACKGROUND


Hypalbuminemia is associated with numerous postoperative complications, so a perioperative albumin substitution is often considered. The objective of SuperAdd is to investigate whether substitution of human albumin, aiming to maintain a serum concentration > 30 g/l, can reduce postoperative complications in normovolemic surgical patients in comparison with standard care.
METHODS/DESIGN


SuperAdd is a single-center, prospective, randomized, outcome-assessor blinded, patient blinded controlled trial. The primary outcome is the frequency of postoperative complications identified using the Postoperative Morbidity Survey graded ≥ 2 according to the Clavien-Dindo Score. Adult patients at risk to develop hypalbuminemia, i.e., ASA III or IV or high-risk surgery, are recruited after written informed consent was obtained. The albumin concentration is assessed before the induction of anesthesia and every 3 h until admission to the postanesthesia care unit. If albumin concentrations drop below 30 g/l, patients are randomly allocated to the control or the treatment group. The study intervention is a goal-directed human albumin substitution aimed at a concentration > 30 g/l during surgery and postanesthesia care unit stay. The patients in the control group are treated according to standard clinical care. Postoperative visits are to be performed on days 1, 3, 5, 8, and 15, as well as by telephone 6 months after surgery.
DISCUSSION


SuperAdd is the first clinical trial in a surgical population investigating the effect of a goal-directed albumin substitution aiming at a serum level > 30 g/l. The nonrestrictive selection of patients guarantees that the patients without albumin screening will most likely not develop hypalbuminemia, thus ensuring generalizability of the study results.
TRIAL REGISTRATION


EudraCT 2016-001313-24. Registered on 5 September 2016. Clinical Trials NCT03167645. Registered on 18 October 2016 and has the Universal Trial Number (UTN) U1111-1181-2625.",2020,"The nonrestrictive selection of patients guarantees that the patients without albumin screening will most likely not develop hypalbuminemia, thus ensuring generalizability of the study results.
","['Registered on 18 October 2016 and has the Universal Trial Number (UTN) U1111-1181-2625', '30', 'adults undergoing vascular, abdominal, trauma, or orthopedic surgery', 'normovolemic surgical patients in comparison with standard care', 'Adult patients at risk to develop hypalbuminemia, i.e., ASA III or IV or high-risk surgery']",['EudraCT'],"['albumin concentration', 'postoperative complications', 'frequency of postoperative complications identified using the Postoperative Morbidity Survey graded ≥\u20092 according to the Clavien-Dindo Score']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",[],"[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.138467,"The nonrestrictive selection of patients guarantees that the patients without albumin screening will most likely not develop hypalbuminemia, thus ensuring generalizability of the study results.
","[{'ForeName': 'Stefan J', 'Initials': 'SJ', 'LastName': 'Schaller', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Fuest', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Ulm', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Catherina', 'Initials': 'C', 'LastName': 'Bubb', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'von Eisenhart-Rothe', 'Affiliation': 'Department of Orthopedics, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Friess', 'Affiliation': 'Department of Surgery, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Chlodwig', 'Initials': 'C', 'LastName': 'Kirchhoff', 'Affiliation': 'Department of Traumatology, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stadlbauer', 'Affiliation': 'Department of Vascular Surgery, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Luppa', 'Affiliation': 'Institute of Clinical Chemistry and Pathobiochemistry, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Blobner', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Jungwirth', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Straße 22, 81675, Munich, Germany. bettina.jungwirth@uniklinik-ulm.de.'}]",Trials,['10.1186/s13063-020-04626-2']
2554,32811575,Psychedelic Science in Post-Covid Psychiatry.,"The medium to long term consequences of COVID-19 are not yet known, though an increase in mental health problems are predicted. Multidisciplinary strategies across socio-economic and psychological levels may be needed to mitigate the mental health burden of COVID-19. Preliminary evidence from the rapidly progressing field of psychedelic science, shows that psilocybin assisted psychotherapy (PAP), offers a promising trans-diagnostic treatment strategy for a range of disorders with restricted and maladaptive habitual patterns of cognition and behaviour, notably depression, addiction and obsessive compulsive disorder (OCD). The COMPASS pathways, phase 2b double blind trial of PAP in antidepressant-free, treatment resistant depression (TRD) is underway across 19 research sites, to determine the safety, efficacy and optimal dose of psilocybin. Results from the Imperial College London Psilodep-RCT comparing the efficacy and mechanisms of action of PAP to the selective serotonin reuptake inhibitor (SSRI) escitalopram will soon be published. However, the efficacy and safety of PAP in conjunction with SSRIs in TRD is not yet known. A new COMPASS study, with a centre in Dublin, will answer this question, with implications for the future delivery of PAP. While at an early stage of clinical development, and notwithstanding the immense challenges of COVID-19, PAP is likely to play an important therapeutic role for certain disorders in post COVID-19 clinical psychiatry.",2020,"The COMPASS pathways, phase 2b double blind trial of PAP in antidepressant-free, treatment resistant depression (TRD) is underway across 19 research sites, to determine the safety, efficacy and optimal dose of psilocybin.",[],['psilocybin assisted psychotherapy (PAP'],['efficacy and safety of PAP'],[],"[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]",,0.129042,"The COMPASS pathways, phase 2b double blind trial of PAP in antidepressant-free, treatment resistant depression (TRD) is underway across 19 research sites, to determine the safety, efficacy and optimal dose of psilocybin.","[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Kelly', 'Affiliation': 'Department of Psychiatry, Trinity College Dublin, Ireland.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Crockett', 'Affiliation': 'Department of Neurological Intervention and Imaging, Sir Charles Gairdner Hospital, Perth, Western Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Alexander', 'Affiliation': 'Health Service Executive, Ireland.'}, {'ForeName': 'Maeve', 'Initials': 'M', 'LastName': 'Haran', 'Affiliation': 'Daughters of Charity Disability Services, Dublin, Ireland.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Baker', 'Affiliation': 'Sheaf House, Exchange Hall, Tallaght, Dublin, Ireland.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Burke', 'Affiliation': 'Sheaf House, Exchange Hall, Tallaght, Dublin, Ireland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Brennan', 'Affiliation': 'Sheaf House, Exchange Hall, Tallaght, Dublin, Ireland.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': ""O'Keane"", 'Affiliation': 'Department of Psychiatry, Trinity College Dublin, Ireland.'}]",Irish journal of psychological medicine,['10.1017/ipm.2020.94']
2555,32814582,Gut microbiota modulation with long-chain corn bran arabinoxylan in adults with overweight and obesity is linked to an individualized temporal increase in fecal propionate.,"BACKGROUND


Variability in the health effects of dietary fiber might arise from inter-individual differences in the gut microbiota's ability to ferment these substrates into beneficial metabolites. Our understanding of what drives this individuality is vastly incomplete and will require an ecological perspective as microbiomes function as complex inter-connected communities. Here, we performed a parallel two-arm, exploratory randomized controlled trial in 31 adults with overweight and class-I obesity to characterize the effects of long-chain, complex arabinoxylan (n = 15) at high supplementation doses (female: 25 g/day; male: 35 g/day) on gut microbiota composition and short-chain fatty acid production as compared to microcrystalline cellulose (n = 16, non-fermentable control), and integrated the findings using an ecological framework.
RESULTS


Arabinoxylan resulted in a global shift in fecal bacterial community composition, reduced α-diversity, and the promotion of specific taxa, including operational taxonomic units related to Bifidobacterium longum, Blautia obeum, and Prevotella copri. Arabinoxylan further increased fecal propionate concentrations (p = 0.012, Friedman's test), an effect that showed two distinct groupings of temporal responses in participants. The two groups showed differences in compositional shifts of the microbiota (p ≤ 0.025, PERMANOVA), and multiple linear regression (MLR) analyses revealed that the propionate response was predictable through shifts and, to a lesser degree, baseline composition of the microbiota. Principal components (PCs) derived from community data were better predictors in MLR models as compared to single taxa, indicating that arabinoxylan fermentation is the result of multi-species interactions within microbiomes.
CONCLUSION


This study showed that long-chain arabinoxylan modulates both microbiota composition and the output of health-relevant SCFAs, providing information for a more targeted application of this fiber. Variation in propionate production was linked to both compositional shifts and baseline composition, with PCs derived from shifts of the global microbial community showing the strongest associations. These findings constitute a proof-of-concept for the merit of an ecological framework that considers features of the wider gut microbial community for the prediction of metabolic outcomes of dietary fiber fermentation. This provides a basis to personalize the use of dietary fiber in nutritional application and to stratify human populations by relevant gut microbiota features to account for the inconsistent health effects in human intervention studies.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT02322112 , registered on July 3, 2015. Video Abstract.",2020,"Arabinoxylan further increased fecal propionate concentrations (p = 0.012, Friedman's test), an effect that showed two distinct groupings of temporal responses in participants.","['adults with overweight and obesity', '31 adults with overweight and class']","['long-chain, complex arabinoxylan', 'gut microbiota composition and short-chain fatty acid production as compared to microcrystalline cellulose', 'long-chain corn bran arabinoxylan']","['global shift in fecal bacterial community composition, reduced α-diversity, and the promotion of specific taxa, including operational taxonomic units related to Bifidobacterium longum, Blautia obeum, and Prevotella copri', 'compositional shifts of the microbiota', 'fecal propionate concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0669247', 'cui_str': 'microcrystalline cellulose'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0353942', 'cui_str': 'Bran'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0318080', 'cui_str': 'Ruminococcus obeum'}, {'cui': 'C1195810', 'cui_str': 'Prevotella copri'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0033474', 'cui_str': 'Propanoates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",31.0,0.039378,"Arabinoxylan further increased fecal propionate concentrations (p = 0.012, Friedman's test), an effect that showed two distinct groupings of temporal responses in participants.","[{'ForeName': 'Nguyen K', 'Initials': 'NK', 'LastName': 'Nguyen', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Edward C', 'Initials': 'EC', 'LastName': 'Deehan', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Zhengxiao', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Mingliang', 'Initials': 'M', 'LastName': 'Jin', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Nami', 'Initials': 'N', 'LastName': 'Baskota', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Maria Elisa', 'Initials': 'ME', 'LastName': 'Perez-Muñoz', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Janis', 'Initials': 'J', 'LastName': 'Cole', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Yunus E', 'Initials': 'YE', 'LastName': 'Tuncil', 'Affiliation': 'Food Engineering Department, Ordu University, 52200, Ordu, Turkey.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Seethaler', 'Affiliation': 'Institute of Nutritional Medicine, University of Hohenheim, 70593, Stuttgart, Germany.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Patient Health Outcomes Research and Clinical Effectiveness Unit, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Laville', 'Affiliation': 'Centre de Recherche en Nutrition Humaine Rhône-Alpes and Centre Européen Nutrition Santé, 69310, Pierre Bénite, France.'}, {'ForeName': 'Nathalie M', 'Initials': 'NM', 'LastName': 'Delzenne', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, Université catholique de Louvain, 1200, Brussels, Belgium.'}, {'ForeName': 'Stephan C', 'Initials': 'SC', 'LastName': 'Bischoff', 'Affiliation': 'Institute of Nutritional Medicine, University of Hohenheim, 70593, Stuttgart, Germany.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Hamaker', 'Affiliation': 'Whistler Center for Carbohydrate Research and Department of Food Science, Purdue University, West Lafayette, IN, 47907, USA.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Martínez', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Knights', 'Affiliation': 'Department of Computer Science and Engineering, University of Minnesota, Minneapolis, MN, 55455, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Bakal', 'Affiliation': 'Patient Health Outcomes Research and Clinical Effectiveness Unit, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Carla M', 'Initials': 'CM', 'LastName': 'Prado', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Walter', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science, University of Alberta, Edmonton, AB, T6G 2E1, Canada. jenswalter@ucc.ie.'}]",Microbiome,['10.1186/s40168-020-00887-w']
2556,32814589,A fast and safe technique for sperm preparation in ICSI treatments within a randomized controlled trial (RCT).,"Recently a novel method based on horizontal sperm migration in injection dishes has been introduced as an additional tool for preparation of semen sample in assisted reproductive technology (ART) procedures. In the present study, we evaluated both timing and reproductive outcomes in a randomized controlled study including 1034 intra-cytoplasmic sperm injection (ICSI) procedures followed by fresh embryo transfer. Couples enrolled were divided into two sub-groups, namely conventional swim-up method (Group A), and horizontal sperm migration in injection dishes (Group B).No significant differences were found between groups with respect to fertilization rate, implantation success, clinical pregnancy outcomes and ongoing pregnancies. On the contrary, both cleavage and blastocyst rates were statistically higher in Group B, suggesting superior efficiency and safety of this innovative technique also including time-saving and cheaper costs as compared to the classical swim-up sperm preparation.Our data support the interpretation of the horizontal sperm migration as a promising procedure for semen preparation in ART cycles.",2020,"On the contrary, both cleavage and blastocyst rates were statistically higher in Group B, suggesting superior efficiency and safety of this innovative technique also including time-saving and cheaper costs as compared to the classical swim-up sperm preparation.",[],['1034 intra-cytoplasmic sperm injection (ICSI) procedures followed by fresh embryo transfer'],"['cleavage and blastocyst rates', 'time-saving and cheaper costs', 'fertilization rate, implantation success, clinical pregnancy outcomes and ongoing pregnancies']",[],"[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0010834', 'cui_str': 'Cytoplasm'}, {'cui': 'C0037868', 'cui_str': 'Spermatozoa'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]","[{'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",1034.0,0.0675263,"On the contrary, both cleavage and blastocyst rates were statistically higher in Group B, suggesting superior efficiency and safety of this innovative technique also including time-saving and cheaper costs as compared to the classical swim-up sperm preparation.","[{'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Baldini', 'Affiliation': 'Momò Fertilife Clinic, Bisceglie, Italy. dbaldini@libero.it.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Baldini', 'Affiliation': 'Momò Fertilife Clinic, Bisceglie, Italy.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Silvestris', 'Affiliation': 'Gynecologic Oncology Unit, IRCCS Istituto Tumori ""Giovanni Paolo II"", Bari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Vizziello', 'Affiliation': 'Momò Fertilife Clinic, Bisceglie, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Ferri', 'Affiliation': 'Momò Fertilife Clinic, Bisceglie, Italy.'}, {'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Vizziello', 'Affiliation': 'Momò Fertilife Clinic, Bisceglie, Italy.'}]",Reproductive biology and endocrinology : RB&E,['10.1186/s12958-020-00642-8']
2557,32814593,Evaluating the effectiveness of learning ear anatomy using holographic models.,"BACKGROUND


Computer-assisted learning has been shown to be an effective means of teaching anatomy, with 3-D visualization technology more successfully improving participants' factual and spatial knowledge in comparison to traditional methods. To date, however, the effectiveness of teaching ear anatomy using 3-D holographic technology has not been studied. The present study aimed to evaluate the feasibility and effectiveness of learning ear anatomy using a holographic (HG) anatomic model in comparison to didactic lecture (DL) and a computer module (CM).
METHODS


A 3-D anatomic model of the middle and inner ear was created and displayed using presentation slides in a lecture, computer module, or via the Microsoft HoloLens. Twenty-nine medical students were randomized to one of the three interventions. All participants underwent assessment of baseline knowledge of ear anatomy. Immediately following each intervention, testing was repeated along with completion of a satisfaction survey.
RESULTS


Baseline test scores did not differ across intervention groups. All groups showed an improvement in anatomic knowledge post-intervention (p < 0.001); the improvement was equal across all interventions (p = 0.06). Participants rated the interventions equally for delivery of factual content (p = 0.96), but rated the HG higher than the DL and CM for overall effectiveness, ability to convey spatial relationships, and for learner engagement and motivation (p < 0.001).
CONCLUSIONS


These results suggest that 3-D holographic technology is an effective method of teaching ear anatomy as compared to DLs and CMs. Furthermore, it is better at engaging and motivating learners compared to traditional methods, meriting its inclusion as a tool in undergraduate medical education curriculum.",2020,All groups showed an improvement in anatomic knowledge post-intervention (p < 0.001); the improvement was equal across all interventions (p = 0.06).,['Twenty-nine medical students'],"['3-D holographic technology', 'didactic lecture (DL) and a computer module (CM', 'learning ear anatomy using a holographic (HG) anatomic model']","['delivery of factual content', 'learner engagement and motivation', 'anatomic knowledge post-intervention']","[{'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0026337', 'cui_str': 'Anatomic Models'}]","[{'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",29.0,0.0314857,All groups showed an improvement in anatomic knowledge post-intervention (p < 0.001); the improvement was equal across all interventions (p = 0.06).,"[{'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Gnanasegaram', 'Affiliation': ""Queen's University School of Medicine, 15 Arch Street, Kingston, K7L 3N6, Canada.""}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Leung', 'Affiliation': ""Queen's University School of Medicine, 15 Arch Street, Kingston, K7L 3N6, Canada.""}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Beyea', 'Affiliation': ""Department of Otolaryngology, Kingston Health Sciences Centre, Queen's University, 144 Brock Street, Kingston, Ontario, K7L 5G2, Canada. jason.beyea@queensu.ca.""}]",Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale,['10.1186/s40463-020-00458-x']
2558,32814610,Cluster randomized trial of an antibiotic time-out led by a team-based pharmacist.,"OBJECTIVE


Antibiotic time-outs (ATOs) have been advocated to improve antibiotic use without dedicated stewardship resources, but their utility is poorly defined. We sought to evaluate the effectiveness of an ATO led by a team-based pharmacist.
DESIGN


Cluster randomized controlled trial.
SETTING


Six medicine teams at an academic medical facility.
PATIENTS


Inpatients who received antibiotics and were cared for by a medicine team.
INTERVENTION


In phase A (2 months) pharmacist-led ATOs were implemented on 3 medicine teams (ATO-A) while 3 teams maintained usual care (UC-A). In phase B (2 months), ATOs were continued in the ATO group (ATO-B) and ATOs were initiated in the UC group (UC ATO-B). We targeted 2 ATO points: early (<72 hours after antibiotics were initiated) and late (after the early period but ≤5 days after antibiotic initiation).
RESULTS


In total, 290 ATOs were documented (181 early, 87 late, and 22 subsequent) among 538 admissions. The most common ATO recommendations were narrow therapy (148 of 290), no change (124 of 290), and change to oral (30 of 290). ATO initiation was lower in the UC ATO-B group than in either ATO group (21.8% UC ATO-B vs 69.2% ATO-A and -B). Overall antibiotic use was not different between the groups (P = .51), although intravenous (IV) levofloxacin use decreased in the UC group after ATO implementation (49 DOT/1,000 PD vs 20 DOT/1,000 PD; P = .022). The ratio of oral (PO) to intravenous (IV) DOT was lower in the UC group than in any of the ATO groups (P = .032). We detected no differences in mortality, length of stay, readmission, C. difficile infection, or antibiotic adverse events.
CONCLUSIONS


Implementation of a pharmacist-led ATO was feasible and well accepted but did not change overall antibiotic use. An ATO may promote increased use of oral antibiotics, but more effective strategies for self-stewardship are needed.",2020,"We detected no differences in mortality, length of stay, readmission, C. difficile infection, or antibiotic adverse events.
","['Six medicine teams at an academic medical facility', 'Inpatients who received antibiotics and were cared for by a medicine team']","['levofloxacin', 'antibiotic time-out led by a team-based pharmacist']","['ratio of oral (PO) to intravenous (IV) DOT', 'mortality, length of stay, readmission, C. difficile infection, or antibiotic adverse events', 'ATO initiation', 'Overall antibiotic use']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0052416', 'cui_str': 'arsenic trioxide'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",290.0,0.0513372,"We detected no differences in mortality, length of stay, readmission, C. difficile infection, or antibiotic adverse events.
","[{'ForeName': 'Trevor C', 'Initials': 'TC', 'LastName': 'Van Schooneveld', 'Affiliation': 'Division of Infectious Disease, Department of Internal Medicine, College of Medicine, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Rupp', 'Affiliation': 'Division of Infectious Disease, Department of Internal Medicine, College of Medicine, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'R Jenifer', 'Initials': 'RJ', 'LastName': 'Cavaleiri', 'Affiliation': 'Division of Infectious Disease, Department of Internal Medicine, College of Medicine, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Lyden', 'Affiliation': 'College of Public Health, University of Nebraska Medical Center, Omaha, Nebraska.'}, {'ForeName': 'Kiri', 'Initials': 'K', 'LastName': 'Rolek', 'Affiliation': 'College of Pharmacy, University of Nebraska Medical Center, Omaha, Nebraska.'}]",Infection control and hospital epidemiology,['10.1017/ice.2020.347']
2559,32814825,"Functional, physiological and subjective responses to concurrent neuromuscular electrical stimulation (NMES) exercise in adult cancer survivors: a controlled prospective study.","The primary aim of this study was to investigate the functional, physiological and subjective responses to NMES exercise in cancer patients. Participants with a cancer diagnosis, currently undergoing treatment, and an had an Eastern Cooperative Oncology Group (ECOG) performance status (ECOG) of 1 and 2 were recommended to participate by their oncologist. Following a 2-week, no-NMES control period, each participant was asked to undertake a concurrent NMES exercise intervention over a 4-week period. Functional muscle strength [30 s sit-to-stand (30STS)], mobility [timed up and go (TUG)], exercise capacity [6-min walk test (6MWT)] and health related quality of life (HR-QoL) were assessed at baseline 1 (BL1), 2-week post control (BL2) and post 4-week NMES exercise intervention (POST). Physiological and subjective responses to LF-NMES were assessed during a 10-stage incremental session, recorded at BL2 and POST. Fourteen participants [mean age: 62 years (10)] completed the intervention. No adverse events were reported. 30STS (+ 2.4 reps, p = .007), and 6MWT (+ 44.3 m, p = .028) significantly improved after the intervention. No changes in TUG or HR-QoL were observed at POST. Concurrent NMES exercise may be an effective exercise intervention for augmenting physical function in participants with cancer and moderate and poor functional status. Implications for cancer survivors: By allowing participants to achieve therapeutic levels of exercise, concurrent NMES may be an effective supportive intervention in cancer rehabilitation.",2020,No adverse events were reported.,"['participants with cancer and moderate and poor functional status', 'Fourteen participants [mean age: 62\xa0years (10', 'cancer patients', 'Participants with a cancer diagnosis, currently undergoing treatment, and an had an Eastern Cooperative Oncology Group (ECOG) performance status (ECOG) of 1 and 2 were recommended to participate by their oncologist', 'adult cancer survivors', 'cancer survivors']","['NMES exercise', 'concurrent neuromuscular electrical stimulation (NMES) exercise', 'NMES exercise intervention', 'Functional muscle strength [30\xa0s sit-to-stand (30STS', 'Concurrent NMES exercise']","['adverse events', ' mobility [timed up and go (TUG)], exercise capacity [6-min walk test (6MWT)] and health related quality of life (HR-QoL', 'TUG or HR-QoL']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0568257,No adverse events were reported.,"[{'ForeName': 'Dominic', 'Initials': 'D', 'LastName': ""O'Connor"", 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland. dominic.oconnor@insight-centre.org.'}, {'ForeName': 'Olive', 'Initials': 'O', 'LastName': 'Lennon', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Matilde Mora', 'Initials': 'MM', 'LastName': 'Fernandez', 'Affiliation': 'Clinica Oncoavanze, Seville, Spain.'}, {'ForeName': 'Gabriel Ruiz', 'Initials': 'GR', 'LastName': 'Signorelli', 'Affiliation': ""The Insight Centre for Data Analytics, O'Brien Centre for Science, University College Dublin, Belfield Campus, Dublin, Ireland.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Caulfield', 'Affiliation': 'School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, Ireland.'}]",Scientific reports,['10.1038/s41598-020-71006-w']
2560,32814852,Effects of a high-intensity interval training session and chocolate milk on appetite and cognitive performance in youth aged 9-13 years.,"BACKGROUND/OBJECTIVES


To investigate the separate and combined effects of a single session of high intensity interval training (HIIT) and chocolate milk on appetite and cognitive performance in youth aged 9-13 years. Blood glucose, salivary cortisol, and subjective emotions were measured to evaluate potential underlying mechanisms contributing to changes in appetite and cognitive performance.
SUBJECTS/METHODS


Using a 2 × 2 repeated measures design, 20 youth (n = 12 girls and n = 8 boys; age = 11.4 ± 0.3 years) performed HIIT on a cycle ergometer (7 × 60 s bouts, interspersed by 60 s active recovery) or sitting, followed by consumption of 163 kcal chocolate milk or water. Capillary blood glucose, salivary cortisol, cognitive performance, and subjective appetite and emotions were assessed at baseline and at several time points post-treatment.
RESULTS


Subjective appetite decreased from baseline following chocolate milk consumption compared water (p = 0.04), and increased from baseline after HIIT compared to sitting (p = 0.01). Participants recalled more words during a short-term memory task and had faster reaction times during an attention task following HIIT compared to sitting (Δ = 1.1 ± 0.02 words, p = 0.03; and Δ = 117.9 ± 23.1 ms, p = 0.01, respectively). Blood glucose increased from baseline following chocolate milk consumption compared to water (at 10 min: Δ = 1.0 ± 0.33 vs. Δ = 0.29 ± 0.060 mmol/L; p < 0.0001).
CONCLUSIONS


Our findings that HIIT may have a positive effect on aspects of cognitive performance suggest that youth should engage in HIIT-like exercise during recesses and lunch at school to attenuate declines in cognitive performance throughout the day. Registered at https://clinicaltrials.gov (NCT03305107).",2020,"Participants recalled more words during a short-term memory task and had faster reaction times during an attention task following HIIT compared to sitting (Δ = 1.1 ± 0.02 words, p = 0.03; and Δ = 117.9 ± 23.1 ms, p = 0.01, respectively).","['20 youth (n\u2009=\u200912 girls and n\u2009=\u20098 boys; age\u2009=\u200911.4\u2009±\u20090.3 years) performed', 'youth aged 9-13 years']","['single session of high intensity interval training (HIIT) and chocolate milk', 'HIIT on a cycle ergometer (7\u2009×\u200960\u2009s bouts, interspersed by 60\u2009s active recovery) or sitting, followed by consumption of 163\u2009kcal chocolate milk or water', 'high-intensity interval training session and chocolate milk']","['appetite and cognitive performance', 'Subjective appetite', 'Capillary blood glucose, salivary cortisol, cognitive performance, and subjective appetite and emotions', 'faster reaction times', 'Blood glucose, salivary cortisol, and subjective emotions', 'Blood glucose']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0520816', 'cui_str': 'Chocolate milk'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]",,0.0728693,"Participants recalled more words during a short-term memory task and had faster reaction times during an attention task following HIIT compared to sitting (Δ = 1.1 ± 0.02 words, p = 0.03; and Δ = 117.9 ± 23.1 ms, p = 0.01, respectively).","[{'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Kucab', 'Affiliation': 'School of Nutrition, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Bellissimo', 'Affiliation': 'School of Nutrition, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada.'}, {'ForeName': 'Cydney', 'Initials': 'C', 'LastName': 'Prusky', 'Affiliation': 'School of Nutrition, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Brett', 'Affiliation': 'School of Nutrition, Ryerson University, 350 Victoria Street, Toronto, ON, M5B 2K3, Canada.'}, {'ForeName': 'Julia O', 'Initials': 'JO', 'LastName': 'Totosy de Zepetnek', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, 3737 Wascana Parkway, Regina, SK, S4S 0A2, Canada. julia.totosy@uregina.ca.'}]",European journal of clinical nutrition,['10.1038/s41430-020-00718-z']
2561,32814922,Analysis of dispatcher-assisted cardiopulmonary resuscitation instructions to laypersons in an out-of-hospital cardiac arrest.,Randomized simulation trial to analyze dispatcher-assisted cardiopulmonary resuscitation instructions provided from the emergency call center in an out-of-hospital heart arrest assisted by lay persons. An analysis of the telephone instructions was performed using a 14-item checklist by two external researchers. Simulations lasted nine minutes. Twenty-one volunteers were enrolled. All of them started resuscitation maneuvers. Telephone instructions were verbalized in very heterogeneous ways. Half of the indicators exceeded 90% compliance. Frequently the recommendation of push hard and fast on the patient's chest was omitted and the dispatcher tended to mark a slower compression rate. The average time from the call to the start of the resuscitation was 3 min 33 s (SD: 1 min 7 s). The telephone instructions were verbalized in a very heterogeneous way. It is necessary to standardize and provide training in how to guide a dispatcher-assisted resuscitation.,2020,Randomized simulation trial to analyze dispatcher-assisted cardiopulmonary resuscitation instructions provided from the emergency call center in an out-of-hospital heart arrest assisted by lay persons.,"['Twenty-one volunteers were enrolled', 'emergency call center in an out-of-hospital heart arrest assisted by lay persons']",['dispatcher-assisted cardiopulmonary resuscitation instructions'],['average time'],"[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C4277665', 'cui_str': 'Call Center'}, {'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}]",21.0,0.0127399,Randomized simulation trial to analyze dispatcher-assisted cardiopulmonary resuscitation instructions provided from the emergency call center in an out-of-hospital heart arrest assisted by lay persons.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ballesteros-Peña', 'Affiliation': 'Organización Sanitaria Integrada Bilbao-Basurto. Bilbao.. sendoa.ballesteros@ehu.eus.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Fernández-Aedo', 'Affiliation': ''}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Vallejo-De la Hoz', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Etayo-Sancho', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Alonso-Pinillos', 'Affiliation': ''}]",Anales del sistema sanitario de Navarra,['10.23938/ASSN.0873']
2562,32814997,Impact of Ixekizumab on Work Productivity in Patients with Ankylosing Spondylitis: Results from the COAST-V and COAST-W Trials at 52 Weeks.,"INTRODUCTION


Patients with ankylosing spondylitis (AS) are burdened with symptoms impacting work productivity measured by presenteeism, absenteeism, overall work impairment, and activity impairment. Ixekizumab, a high-affinity monoclonal antibody selectively targeting interleukin-17A, has been demonstrated to improve disease signs and symptoms in two phase 3 trials of AS. This study investigated for 52 weeks the effect of ixekizumab treatment on work productivity in patients with active AS.
METHODS


COAST-V (NCT02696785) and COAST-W (NCT02696798) were phase 3, multicenter, randomized, controlled trials investigating the efficacy of ixekizumab 80 mg every 4 weeks (Q4W) and every 2 weeks (Q2W) in patients with AS naïve to biologic disease-modifying antirheumatic drugs (bDMARDs; COAST-V) or who were inadequate responders or intolerant to tumor necrosis factor inhibitors (TNFi; COAST-W). Work productivity was measured with the Work Productivity and Activity Impairment Questionnaire for Spondyloarthritis at weeks 16 and 52. Absenteeism, presenteeism, and overall work impairment were assessed for patients reporting paid work. Activity impairment was assessed regardless of work status.
RESULTS


At baseline, 66.2% (434/656) of patients reported paid work. At week 16, bDMARD-naïve patients treated with both ixekizumab dose regimens and TNFi-experienced patients treated with ixekizumab Q2W reported significant improvements in activity impairment (p < 0.01 and p < 0.05, respectively). TNFi-experienced patients treated with ixekizumab showed significant improvements versus placebo in presenteeism and overall work impairment (p < 0.05); bDMARD-naïve patients had numeric improvements. After week 16, patients initially on placebo switched to ixekizumab and patients already treated with ixekizumab continued treatment. Improvements in work productivity and daily activity were sustained through week 52 for both bDMARD-experienced and -naïve patients.
CONCLUSION


Both bDMARD-naïve and TNFi-experienced patients with AS had greater improvements in work productivity and activity impairment when receiving ixekizumab compared to placebo at week 16. Improvements in work productivity and activity impairment achieved at week 16 were sustained through week 52 with ixekizumab treatment.",2020,"Improvements in work productivity and daily activity were sustained through week 52 for both bDMARD-experienced and -naïve patients.
","['Patients with ankylosing spondylitis (AS', 'Patients with Ankylosing Spondylitis', 'patients with AS naïve to biologic disease-modifying antirheumatic drugs (bDMARDs; COAST-V) or who were inadequate responders or', 'patients with active AS']","['ixekizumab treatment', 'placebo', 'intolerant to tumor necrosis factor inhibitors (TNFi; COAST-W', 'ixekizumab 80\xa0mg every 4\xa0weeks (Q4W) and every 2\xa0weeks (Q2W', 'Ixekizumab', 'ixekizumab Q2W', 'ixekizumab']","['Activity impairment', 'work productivity and daily activity', 'Work Productivity and Activity Impairment Questionnaire', 'Work Productivity', 'Work productivity', 'Absenteeism, presenteeism, and overall work impairment', 'presenteeism and overall work impairment', 'work productivity and activity impairment', 'activity impairment']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C1275555', 'cui_str': 'Every four weeks'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0640566,"Improvements in work productivity and daily activity were sustained through week 52 for both bDMARD-experienced and -naïve patients.
","[{'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Marzo-Ortega', 'Affiliation': 'National Institute for Health Research-Leeds Biomedical Research Centre (NIHR-LBRC), Leeds Teaching Hospitals Trust and Leeds Institute of Rheumatic and Musculoskeletal Medicine (LIRMM), University of Leeds, Leeds, West Yorkshire, UK. h.marzo-ortega@leeds.ac.uk.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Mease', 'Affiliation': 'Swedish Medical Center-Providence St. Joseph Health and University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Proton', 'Initials': 'P', 'LastName': 'Rahman', 'Affiliation': ""Memorial University of Newfoundland, St. John's, NL, Canada.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Navarro-Compán', 'Affiliation': 'Hospital Universitario La Paz IdiPaz, Madrid, Spain.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Strand', 'Affiliation': 'Division Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Department of Rheumatology, Cochin Hospital, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Combe', 'Affiliation': 'Department of Rheumatology, CHU Montpellier and Montpellier University, Montpellier, France.'}, {'ForeName': 'James Cheng-Chung', 'Initials': 'JC', 'LastName': 'Wei', 'Affiliation': 'Graduate Institute of Integrated Medicine, Chung Shan Medical University, China Medical University, Taichung City, Taiwan.'}, {'ForeName': 'Xenofon', 'Initials': 'X', 'LastName': 'Baraliakos', 'Affiliation': 'St. Elisabeth Group GmbH, Herne, Germany.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Hunter', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sandoval', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Baojin', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Bessette', 'Affiliation': 'Centre hospitalier universitaire de Québec-Laval University, Quebec City, QC, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Deodhar', 'Affiliation': 'Division of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, OR, USA.'}]",Rheumatology and therapy,['10.1007/s40744-020-00225-4']
2563,32815386,Efficacy of electroacupuncture plus warm needling therapy for plantar heel pain: a randomised waitlist-controlled trial.,"OBJECTIVE


To investigate the therapeutic effects of electroacupuncture plus warm needling (EAWN) therapy on pain and foot function in adults with plantar heel pain (PHP).
METHODS


This prospective, randomised, parallel-group, waitlist-controlled trial was conducted at a Chinese medicine centre in Hong Kong between May 2018 and February 2019. Eighty eligible community-dwelling subjects with PHP (mean age 59.7 years; 85% female) were equally randomised to receive EAWN therapy or remain on a waitlist. The treatment group received six 30-min sessions of standardised EAWN therapy over 4 weeks; the control group received no treatment. The outcome measures were the visual analogue scale (VAS) score for first-step pain, foot function index (FFI) scores and global rating of change (GRC) scale scores. Assessments were made at baseline, week 2 and week 4 (primary endpoint). The treatment group underwent additional assessments at week 8. Outcomes were evaluated by intention-to-treat analysis.
RESULTS


Patients who received EAWN therapy exhibited greater improvements in the mean first-step pain VAS and all FFI scores than did those in the control group at weeks 2 and 4, with significant between-group differences (all  P  < 0.001). Compared with baseline, there were significant decreases in mean first-step pain VAS scores at weeks 2 and 4, and FFI scores at week 4, in the treatment group but not in the control group. The improvements in the treatment group continued until week 8. GRC scores at week 4 indicated improvement in all treated patients and only 22.5% of the control group patients ( P  < 0.001). There were no study-related adverse events.
CONCLUSION


EAWN therapy could be an effective treatment for PHP in middle-aged and older adults.
TRIAL REGISTRATION NUMBER


ChiCTR1800014906 (Chinese Clinical Trials Registry).",2020,"RESULTS


Patients who received EAWN therapy exhibited greater improvements in the mean first-step pain VAS and all FFI scores than did those in the control group at weeks 2 and 4, with significant between-group differences (all  P  < 0.001).","['Eighty eligible community-dwelling subjects with PHP (mean age 59.7\u2009years; 85% female', 'middle-aged and older adults', 'Chinese medicine centre in Hong Kong between May 2018 and February 2019', 'plantar heel pain', 'adults with plantar heel pain (PHP']","['electroacupuncture plus warm needling therapy', 'electroacupuncture plus warm needling (EAWN) therapy']","['FFI scores', 'mean first-step pain VAS and all FFI scores', 'pain and foot function', 'visual analogue scale (VAS) score for first-step pain, foot function index (FFI) scores and global rating of change (GRC) scale scores', 'mean first-step pain VAS scores', 'GRC scores']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0231786', 'cui_str': 'Plantar heel pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4706287', 'cui_str': 'Foot Function Index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",80.0,0.0808319,"RESULTS


Patients who received EAWN therapy exhibited greater improvements in the mean first-step pain VAS and all FFI scores than did those in the control group at weeks 2 and 4, with significant between-group differences (all  P  < 0.001).","[{'ForeName': 'Lai Fun', 'Initials': 'LF', 'LastName': 'Ho', 'Affiliation': 'Chinese Medicine Services, Pok Oi Hospital, Hong Kong, China.'}, {'ForeName': 'Yuanqi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Chinese Medicine Services, Pok Oi Hospital, Hong Kong, China.'}, {'ForeName': 'Jessica Yuet-Ling', 'Initials': 'JY', 'LastName': 'Ching', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Kam Leung', 'Initials': 'KL', 'LastName': 'Chan', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Ping Him', 'Initials': 'PH', 'LastName': 'Tsang', 'Affiliation': 'Chinese Medicine Services, Pok Oi Hospital, Hong Kong, China.'}, {'ForeName': 'Man Hin', 'Initials': 'MH', 'LastName': 'Wong', 'Affiliation': 'Chinese Medicine Services, Pok Oi Hospital, Hong Kong, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Chinese Medicine Services, Pok Oi Hospital, Hong Kong, China.'}, {'ForeName': 'Liyi', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Chinese Medicine Services, Pok Oi Hospital, Hong Kong, China.'}, {'ForeName': 'Bacon Fung-Leung', 'Initials': 'BF', 'LastName': 'Ng', 'Affiliation': 'Chinese Medicine Department, Hospital Authority, Hong Kong, China.'}, {'ForeName': 'Zhi Xiu', 'Initials': 'ZX', 'LastName': 'Lin', 'Affiliation': 'School of Chinese Medicine, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420946048']
2564,32815416,"Anti-Thrombotic Therapy to Ameliorate Complications of COVID-19 (ATTACC): Study design and methodology for an international, adaptive Bayesian randomized controlled trial.","BACKGROUND


Mortality from COVID-19 is high among hospitalized patients and effective therapeutics are lacking. Hypercoagulability, thrombosis and hyperinflammation occur in COVID-19 and may contribute to severe complications. Therapeutic anticoagulation may improve clinical outcomes through anti-thrombotic, anti-inflammatory and anti-viral mechanisms. Our primary objective is to evaluate whether therapeutic-dose anticoagulation with low-molecular-weight heparin or unfractionated heparin prevents mechanical ventilation and/or death in patients hospitalized with COVID-19 compared to usual care.
METHODS


An international, open-label, adaptive randomized controlled trial. Using a Bayesian framework, the trial will declare results as soon as pre-specified posterior probabilities for superiority, futility, or harm are reached. The trial uses response-adaptive randomization to maximize the probability that patients will receive the more beneficial treatment approach, as treatment effect information accumulates within the trial. By leveraging a common data safety monitoring board and pooling data with a second similar international Bayesian adaptive trial (REMAP-COVID anticoagulation domain), treatment efficacy and safety will be evaluated as efficiently as possible. The primary outcome is an ordinal endpoint with three possible outcomes based on the worst status of each patient through day 30: no requirement for invasive mechanical ventilation, invasive mechanical ventilation or death.
CONCLUSION


Using an adaptive trial design, the Anti-Thrombotic Therapy To Ameliorate Complications of COVID-19 trial will establish whether therapeutic anticoagulation can reduce mortality and/or avoid the need for mechanical ventilation in patients hospitalized with COVID-19. Leveraging existing networks to recruit sites will increase enrollment and mitigate enrollment risk in sites with declining COVID-19 cases.",2020,"Using a Bayesian framework, the trial will declare results as soon as pre-specified posterior probabilities for superiority, futility, or harm are reached.","['patients hospitalized with COVID-19 compared to usual care', 'patients hospitalized with COVID-19']","['ATTACC', 'low-molecular-weight heparin or unfractionated heparin']","['mechanical ventilation and/or death', 'worst status of each patient through day 30: no requirement for invasive mechanical ventilation, invasive mechanical ventilation or death', 'Complications of COVID-19']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0019134', 'cui_str': 'heparin'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]",,0.254399,"Using a Bayesian framework, the trial will declare results as soon as pre-specified posterior probabilities for superiority, futility, or harm are reached.","[{'ForeName': 'Brett L', 'Initials': 'BL', 'LastName': 'Houston', 'Affiliation': 'Max Rady Faculty of Health Sciences, Max Rady College of Medicine, Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Patrick R', 'Initials': 'PR', 'LastName': 'Lawler', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Ewan C', 'Initials': 'EC', 'LastName': 'Goligher', 'Affiliation': 'Toronto General Hospital Research Institute, Toronto, ON, Canada.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Bradbury', 'Affiliation': 'Faculty of Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Carrier', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Dzavik', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Fowler', 'Affiliation': 'Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jean-Phillippe', 'Initials': 'JP', 'LastName': 'Galanaud', 'Affiliation': 'Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Gross', 'Affiliation': 'Thrombosis and Atherosclerosis Research Institute, Department of Medicine, McMaster University & Hamilton Health Sciences, Hamilton, ON, Canada.'}, {'ForeName': 'Emily G', 'Initials': 'EG', 'LastName': 'McDonald', 'Affiliation': 'Clinical Practice Assessment Unit, Department of Medicine, McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Kahn', 'Affiliation': 'Center for Clinical Epidemiology, Jewish General Hospital/Lady Davis Institute, Division of Internal Medicine, Department of Medicine, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Max Rady Faculty of Health Sciences, Max Rady College of Medicine, Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': ""Department of Surgery, St Michael's Hospital and the University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'The University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Arthur S', 'Initials': 'AS', 'LastName': 'Slutsky', 'Affiliation': ""Keenan Research Centre at the Li Ka Shing Knowledge Institute, St. Michael's Hospital and Departments of Medicine, Surgery, and Biomedical Engineering, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Alexis F', 'Initials': 'AF', 'LastName': 'Turgeon', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Division of Critical Care Medicine, Faculty of Medicine, Université Laval, Québec, QC, Canada.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC, Austin, TX, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Rosenson', 'Affiliation': 'The Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Mount Sinai Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Escobedo', 'Affiliation': 'Medical Research Unit on Clinical Epidemiology, Mexican Social Security Institute, Mexico City, Mexico.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Bond', 'Affiliation': 'Ozmosis Research Inc., Toronto, ON, Canada.'}, {'ForeName': 'Bridget-Anne', 'Initials': 'BA', 'LastName': 'Kirwan', 'Affiliation': 'Department of Clinical Research, SOCAR Research SA, Nyon, Switzerland.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'de Brouwer', 'Affiliation': 'Department of Clinical Research, SOCAR Research SA, Nyon, Switzerland.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Zarychanski', 'Affiliation': 'Max Rady Faculty of Health Sciences, Max Rady College of Medicine, Department of Internal Medicine, University of Manitoba, Winnipeg, MB, Canada.'}]","Clinical trials (London, England)",['10.1177/1740774520943846']
2565,32815418,Exploring mechanisms of action in clinical trials of complex surgical interventions using mediation analysis.,"BACKGROUND


Surgical interventions allow for tailoring of treatment to individual patients and implementation may vary with surgeon and healthcare provider. In addition, in clinical trials assessing two competing surgical interventions, the treatments may be accompanied by co-interventions.
AIMS


This study explores the use of causal mediation analysis to (1) delineate the treatment effect that results directly from the surgical intervention under study and the indirect effect acting through a co-intervention and (2) to evaluate the benefit of the surgical intervention if either everybody in the trial population received the co-intervention or nobody received it.
METHODS


Within a counterfactual framework, relevant direct and indirect effects of a surgical intervention are estimated and adjusted for confounding via parametric regression models, for the situation where both mediator and outcome are binary, with baseline stratification factors included as fixed effects and surgeons as random intercepts. The causal difference in probability of a successful outcome (estimand of interest) is calculated using Monte Carlo simulation with bootstrapping for confidence intervals. Packages for estimation within standard statistical software are reviewed briefly. A step by step application of methods is illustrated using the Amaze randomised trial of ablation as an adjunct to cardiac surgery in patients with irregular heart rhythm, with a co-intervention (removal of the left atrial appendage) administered to a subset of participants at the surgeon's discretion. The primary outcome was return to normal heart rhythm at one year post surgery.
RESULTS


In Amaze, 17% (95% confidence interval: 6%, 28%) more patients in the active arm had a successful outcome, but there was a large difference between active and control arms in the proportion of patients who received the co-intervention (55% and 30%, respectively). Causal mediation analysis suggested that around 1% of the treatment effect was attributable to the co-intervention (16% natural direct effect). The controlled direct effect ranged from 18% (6%, 30%) if the co-intervention were mandated, to 14% (2%, 25%) if it were prohibited. Including age as a moderator of the mediation effects showed that the natural direct effect of ablation appeared to decrease with age.
CONCLUSIONS


Causal mediation analysis is a useful quantitative tool to explore mediating effects of co-interventions in surgical trials. In Amaze, investigators could be reassured that the effect of the active treatment, not explainable by differential use of the co-intervention, was significant across analyses.",2020,"In Amaze, 17% (95% confidence interval: 6%, 28%) more patients in the active arm had a successful outcome, but there was a large difference between active and control arms in the proportion of patients who received the co-intervention (55% and 30%, respectively).","[""patients with irregular heart rhythm, with a co-intervention (removal of the left atrial appendage) administered to a subset of participants at the surgeon's discretion""]",['co-intervention or nobody received it'],['return to normal heart rhythm at one year post surgery'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205271', 'cui_str': 'Irregular'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0225832', 'cui_str': 'Structure of auricular appendage'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0232187', 'cui_str': 'Cardiac rhythm type'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",,0.133141,"In Amaze, 17% (95% confidence interval: 6%, 28%) more patients in the active arm had a successful outcome, but there was a large difference between active and control arms in the proportion of patients who received the co-intervention (55% and 30%, respectively).","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Sharples', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Olympia', 'Initials': 'O', 'LastName': 'Papachristofi', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Saleema', 'Initials': 'S', 'LastName': 'Rex', 'Affiliation': 'Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""King's College London, London, UK.""}]","Clinical trials (London, England)",['10.1177/1740774520947644']
2566,32815423,Clinical review of the efficacy and safety of oral semaglutide in patients with type 2 diabetes considered for injectable GLP-1 receptor agonist therapy or currently on insulin therapy.,"Injectable therapies such as glucagon-like peptide-1 receptor agonists (GLP-1RAs) and insulin are high-efficacy options for people with type 2 diabetes (T2D) who require treatment intensification. In addition to high glycemic efficacy, GLP-1RAs offer weight loss benefits, and some agents have been shown to reduce cardiovascular risk. This article summarizes data from two clinical studies with the first oral GLP-1RA, oral semaglutide, in situations where injectable therapy is often considered, and provides guidance on use in primary care. PIONEER 4 compared oral semaglutide 14 mg with an injectable GLP-1RA, liraglutide 1.8 mg, or placebo in patients uncontrolled on oral glucose-lowering therapies. PIONEER 8 compared oral semaglutide with placebo in patients with T2D already on insulin therapy. Treatment with oral semaglutide gave similar reductions in glycated hemoglobin (HbA 1c ) compared with liraglutide at 26 weeks, and significantly greater reductions at 52 weeks. Changes in body weight with oral semaglutide were significantly greater compared with liraglutide after 26 and 52 weeks. Adding oral semaglutide 7 or 14 mg to insulin resulted in significant reductions in HbA 1c  and body weight at both 26 and 52 weeks compared with placebo, and facilitated a decrease in total daily insulin dosage. Oral semaglutide was associated with low proportions of patients experiencing severe or blood-glucose-confirmed symptomatic hypoglycemia when added to oral glucose-lowering therapies, and did not increase the incidence of such events when added to insulin. The tolerability profile of oral semaglutide was consistent with that seen for injectable GLP-1RAs, with gastrointestinal side effects seen most frequently; most were transient and tended to occur during dose escalation. For patients requiring treatment intensification after oral therapy or as add-on to insulin, oral semaglutide provides effective glucose lowering and body weight loss, with low risk of hypoglycemia, thus broadening the range of therapeutic options for treatment of T2D in primary care.",2020,"Adding oral semaglutide 7 or 14 mg to insulin resulted in significant reductions in HbA 1c  and body weight at both 26 and 52 weeks compared with placebo, and facilitated a decrease in total daily insulin dosage.","['people with type 2 diabetes (T2D) who require treatment intensification', 'patients with T2D already on insulin therapy', 'patients with type 2 diabetes considered for injectable GLP-1 receptor agonist therapy or currently on insulin therapy', 'patients uncontrolled on oral glucose-lowering therapies']","['liraglutide', 'oral semaglutide', 'oral semaglutide 14 mg with an injectable GLP-1RA, liraglutide 1.8 mg, or placebo', 'glucagon-like peptide-1 receptor agonists (GLP-1RAs) and insulin', 'placebo']","['HbA 1c  and body weight', 'body weight with oral semaglutide', 'total daily insulin dosage', 'body weight loss', 'low proportions of patients experiencing severe or blood-glucose-confirmed symptomatic hypoglycemia', 'glycated hemoglobin (HbA 1c ', 'tolerability profile of oral semaglutide']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0018301', 'cui_str': 'Guadeloupe island'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0294087,"Adding oral semaglutide 7 or 14 mg to insulin resulted in significant reductions in HbA 1c  and body weight at both 26 and 52 weeks compared with placebo, and facilitated a decrease in total daily insulin dosage.","[{'ForeName': 'Eugene E', 'Initials': 'EE', 'LastName': 'Wright', 'Affiliation': 'Charlotte Area Health Education Center , Charlotte, NC, USA.'}, {'ForeName': 'Vanita R', 'Initials': 'VR', 'LastName': 'Aroda', 'Affiliation': ""Brigham and Women's Hospital; Harvard Medical School , Boston, MA, USA.""}]",Postgraduate medicine,['10.1080/00325481.2020.1798127']
2567,32815436,Clinical review of the efficacy and safety of oral semaglutide in patients with type 2 diabetes compared with other oral antihyperglycemic agents and placebo.,"Oral semaglutide is a tablet formulation of a glucagon-like peptide-1 receptor agonist (GLP-1RA), recently approved in the USA and other countries. This paper reviews data from clinical trials (PIONEER 1, 2, 3, and 7) comparing oral semaglutide (once-daily doses of 3, 7, or 14 mg) with either once-daily placebo, empagliflozin 25 mg, or sitagliptin 100 mg. After 26 weeks in PIONEER 1, patients randomized to 3, 7, or 14 mg doses of oral semaglutide monotherapy had statistically significant reductions in glycated hemoglobin (HbA 1c ) of 0.9%, 1.2%, and 1.4%, respectively, versus 0.3% with placebo. In the active-comparator studies, oral semaglutide 14 mg provided better glycemic control than empagliflozin or sitagliptin after 26 weeks, with durable effects. Body weight reductions were significantly greater with oral semaglutide than with placebo and sitagliptin. However, body weight reductions with oral semaglutide 14 mg versus empagliflozin 25 mg were not significantly different. Gastrointestinal adverse events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early in the course of treatment, and abated over time. Across these trials, 5-13% and 15-20% of patients experienced nausea with oral semaglutide 7 and 14 mg, respectively, and 2.3-3.4% and 5.1-8.0%, respectively, discontinued treatment due to gastrointestinal AEs. Severe or blood glucose-confirmed symptomatic hypoglycemia occurred infrequently with oral semaglutide and was seen most often in patients taking concomitant sulfonylureas. Findings from these trials indicate that addition of oral semaglutide reduces HbA 1c  and body weight and is associated with a low risk of hypoglycemia. Oral semaglutide represents an additional option for treating people with type 2 diabetes in primary care, with the potential to expand the numbers of patients benefiting from GLP-1RAs beyond that currently seen with injectable formulations.",2020,"Gastrointestinal adverse events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early in the course of treatment, and abated over time.",['patients with type 2 diabetes'],"['Oral semaglutide', 'oral semaglutide monotherapy', 'empagliflozin', 'oral antihyperglycemic agents and placebo', 'placebo, empagliflozin 25 mg, or sitagliptin 100 mg', 'oral semaglutide', 'placebo']","['HbA 1c  and body weight', 'Body weight reductions', 'glycated hemoglobin (HbA 1c ', 'Severe or blood glucose-confirmed symptomatic hypoglycemia', 'body weight reductions', 'nausea', 'Gastrointestinal adverse events (AEs) with oral semaglutide']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3848772', 'cui_str': 'empagliflozin 25 MG [Jardiance]'}, {'cui': 'C1812980', 'cui_str': 'sitagliptin 100 MG'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}]",,0.127093,"Gastrointestinal adverse events (AEs) with oral semaglutide were mostly mild-to-moderate, occurred early in the course of treatment, and abated over time.","[{'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Lavernia', 'Affiliation': 'North Broward Diabetes Center , Pompano Beach, FL, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Blonde', 'Affiliation': 'Department of Endocrinology, Ochsner Medical Center , New Orleans, LA, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1798638']
2568,32815438,The efficacy of the figure-of-eight suture technique in the treatment of tunnel bleeding of the femoral artery route after percutaneous coronary intervention or angiography.,"OBJECTIVE


To evaluate the efficacy of the figure-of-eight (FOE) suture technique in the treatment of tunnel bleeding after femoral artery puncture compared with manual compression (MC).
METHODS


This prospective, randomized, controlled study enrolled patients that had received transfemoral coronary artery angiography or percutaneous coronary intervention and then developed tunnel bleeding. They were randomly assigned into two groups: FOE suture group (ES group) and manual compression group (MC group). Total treatment time, performance frequency, performance time, rate of deep vein thrombosis (DVT) and in-hospital time after the procedure were compared.
RESULTS


A total of 152 patients were enrolled in the study (ES group,  n  = 63; MC group,  n  = 89). Compared with the MC group, the total treatment time (mean ± SD: ES 22.3 ± 5.4 h versus MC 26.8 ± 6.8 h), performance frequency (mean ± SD: ES 2.1 ± 0.7 versus MC 2.6 ± 1.1), performance time (mean ± SD: ES 8.9 ± 2.5 min versus MC 12.3 ± 4.1 min), in-hospital time after the procedure (mean ± SD: ES 3.5 ± 1.2 days versus MC 4.8 ± 2.1 days) and DVT rate (ES 0.0% versus MC 6.7%) were significantly lower in the ES group.
CONCLUSION


The FOE suture technique effectively treated tunnel bleeding after femoral artery puncture.",2020,"Compared with the MC group, the total treatment time (mean ± SD: ES 22.3 ± 5.4 h versus MC 26.8 ± 6.8 h), performance frequency (mean ± SD: ES 2.1 ± 0.7 versus MC 2.6 ± 1.1), performance time (mean ± SD: ES 8.9 ± 2.5 min versus MC 12.3 ± 4.1 min), in-hospital time after the procedure (mean ± SD: ES 3.5 ± 1.2 days versus MC 4.8 ± 2.1 days) and DVT rate (ES 0.0% versus MC 6.7%) were significantly lower in the ES group.
","['tunnel bleeding after femoral artery puncture', 'A total of 152 patients were enrolled in the study (ES group,  n \u2009=\u200963; MC group,  n \u2009=\u200989', 'enrolled patients that had received transfemoral coronary artery angiography or percutaneous coronary intervention and then developed tunnel bleeding', 'tunnel bleeding of the femoral artery route after percutaneous coronary intervention or angiography']","['FOE suture group (ES group) and manual compression group (MC group', 'manual compression (MC', 'figure-of-eight (FOE) suture technique', 'figure-of-eight suture technique']","['Total treatment time, performance frequency, performance time, rate of deep vein thrombosis (DVT) and in-hospital time', 'tunnel bleeding', 'hospital time', 'performance time', 'DVT rate', 'total treatment time']","[{'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0013153', 'cui_str': 'Route of administration'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0038968', 'cui_str': 'Suturing techniques'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",152.0,0.0311078,"Compared with the MC group, the total treatment time (mean ± SD: ES 22.3 ± 5.4 h versus MC 26.8 ± 6.8 h), performance frequency (mean ± SD: ES 2.1 ± 0.7 versus MC 2.6 ± 1.1), performance time (mean ± SD: ES 8.9 ± 2.5 min versus MC 12.3 ± 4.1 min), in-hospital time after the procedure (mean ± SD: ES 3.5 ± 1.2 days versus MC 4.8 ± 2.1 days) and DVT rate (ES 0.0% versus MC 6.7%) were significantly lower in the ES group.
","[{'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, The First Medical Centre, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Jing-Guo', 'Initials': 'JG', 'LastName': 'Nong', 'Affiliation': 'Department of Cardiology, The First Medical Centre, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Cardiology, The First Medical Centre, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Quan-Zhou', 'Initials': 'QZ', 'LastName': 'Feng', 'Affiliation': 'Department of Cardiology, The First Medical Centre, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Cai-Yi', 'Initials': 'CY', 'LastName': 'Lu', 'Affiliation': 'Department of Cardiology, The First Medical Centre, Chinese PLA General Hospital, Beijing, China.'}]",The Journal of international medical research,['10.1177/0300060520947307']
2569,32815439,"Oral semaglutide in patients with type 2 diabetes and cardiovascular disease, renal impairment, or other comorbidities, and in older patients.","Patients with type 2 diabetes (T2D) often have comorbidities, such as cardiovascular disease or chronic kidney disease, and a large and growing proportion of the T2D patient population is over 65 years. There are many therapies for the treatment of T2D but not all are suitable for patients with comorbidities. Oral semaglutide is a tablet formulation of a glucagon-like peptide-1 receptor agonist (GLP-1RA) and was recently approved for the treatment of T2D, representing an oral alternative to injectable GLP-1RAs. This article reviews data from: PIONEER 6, a phase 3a cardiovascular outcomes trial in patients at high cardiovascular risk; PIONEER 5, a phase 3a trial in patients with moderate renal impairment; a post-hoc analysis of PIONEER data by age; and pharmacokinetic trials investigating the effects of renal impairment, gastrointestinal disease, and hepatic impairment on the exposure of oral semaglutide. PIONEER 6 demonstrated the cardiovascular safety of oral semaglutide compared with placebo (hazard ratio: 0.79; 95% confidence interval [CI]: 0.57, 1.11; p < 0.001 for noninferiority), ruling out excess cardiovascular risk. In PIONEER 5, oral semaglutide was superior to placebo in decreasing glycated hemoglobin over 26 weeks (estimated treatment difference [ETD]: -0.8%; 95% CI: -1.0, -0.6; p < 0.0001) and body weight (ETD: -2.5 kg; 95% CI: -3.2, -1.8; p < 0.0001), and renal function was unchanged in both treatment groups. There was no effect of age on glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment did not affect the pharmacokinetics of semaglutide. Across the trials, the safety profile of oral semaglutide was as expected for a GLP-1RA, with gastrointestinal adverse events most commonly reported. As such, oral semaglutide provides an effective oral GLP-1RA treatment option in older patients and/or those with comorbidities, with no requirements for dose adjustment.",2020,There was no effect of age on glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment did not affect the pharmacokinetics of semaglutide.,"['older patients and/or those with comorbidities', 'patients with comorbidities', 'patients at high cardiovascular risk', 'Patients with type 2 diabetes (T2D) often have comorbidities, such as cardiovascular disease or chronic kidney disease, and a large and growing proportion of the T2D patient population is over 65 years', 'patients with type 2 diabetes and cardiovascular disease, renal impairment, or other comorbidities, and in older patients', 'patients with moderate renal impairment']","['Oral semaglutide', 'ETD', 'placebo']","['renal function', 'body weight', 'glycated hemoglobin', 'cardiovascular safety of oral semaglutide', 'safety profile of oral semaglutide', 'glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3203348', 'cui_str': 'Upper gastrointestinal tract structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0948807', 'cui_str': 'Hepatic impairment'}]",,0.0838752,There was no effect of age on glycemic efficacy of oral semaglutide and the presence of upper gastrointestinal disease or hepatic impairment did not affect the pharmacokinetics of semaglutide.,"[{'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Faculty of Medicine, Hebrew University of Jerusalem , Israel.'}, {'ForeName': 'Eden M', 'Initials': 'EM', 'LastName': 'Miller', 'Affiliation': 'Diabetes Nation , Bend, OR, USA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Warren', 'Affiliation': 'Physicians East , Greenville, NC, USA.'}]",Postgraduate medicine,['10.1080/00325481.2020.1800286']
2570,32815644,Differential effects of a school-based obesity prevention program: A cluster randomized trial.,"School-based healthy living interventions are widely promoted as strategies for preventing obesity. The peer-led Healthy Buddies™ curriculum has been shown to improve obesity-related outcomes in school-aged children. We examined whether these improvements existed among subgroups of children stratified by sex, income level and urban/rural geography. In a cluster-randomized controlled trial, elementary schools in Manitoba, Canada, were randomly allocated to Healthy Buddies™ (10 schools, 340 students) or standard curriculum (10 schools, 347 students). Healthy Buddies™ participants had 21weekly lessons on healthy eating, physical activity and self-efficacy, delivered by children age 9-12 to children age 6-8. We assessed pre- and post-intervention body mass index (BMI) z-scores, waist circumference, healthy living knowledge, dietary intake and self-efficacy among the younger children. Compared to standard curriculum (n = 154), Healthy Buddies™ participants (n = 157) experienced a greater reduction in waist circumference (-1.7 cm; 95% confidence interval [CI][-2.8, -0.5 cm]) and improved dietary intake (4.6; 95% CI [0.9, 8.3]), healthy living knowledge (5.9; 95% CI [2.3, 9.5]) and self-efficacy (5.3; 95% CI [1.0, 9.5]) scores. In subgroup analyses, effects for waist circumference (-2.0 cm; 95% CI [-3.6, -0.5]), healthy living knowledge (9.1; 95% CI [4.4, 13.8]) and self-efficacy (8.3; 95% CI [3.3, 13.3]) were significant among boys. Dietary intake (10.5; 95% CI [5.5, 15.4]), healthy living knowledge (9.8; 95% CI [4.5, 15.0]) and self-efficacy (6.7; 95% CI [0.7, 12.7]) improved among urban-dwelling but not rural-dwelling children. Healthy Buddies™ was effective for boys and children living in urban settings. Enhanced curricula may be needed to improve program effectiveness for select subgroups of school-aged children.",2020,"Dietary intake (10.5; 95% CI [5.5, 15.4]), healthy living knowledge (9.8; 95% CI [4.5, 15.0]) and self-efficacy (6.7","['elementary schools in Manitoba, Canada, were randomly allocated to Healthy Buddies™ (10 schools, 340 students) or standard curriculum (10 schools, 347 students', 'school-aged children', 'subgroups of children stratified by sex, income level and urban/rural geography', ' delivered by children age 9-12 to children age 6-8', 'boys and children living in urban settings']","['School-based healthy living interventions', 'school-based obesity prevention program']","['waist circumference', 'dietary intake', 'healthy eating, physical activity and self-efficacy', 'healthy living knowledge', 'pre- and post-intervention body mass index (BMI) z-scores, waist circumference, healthy living knowledge, dietary intake and self-efficacy', 'Dietary intake', 'self-efficacy']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0024726', 'cui_str': 'Manitoba'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0017447', 'cui_str': 'Geography'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",347.0,0.0773898,"Dietary intake (10.5; 95% CI [5.5, 15.4]), healthy living knowledge (9.8; 95% CI [4.5, 15.0]) and self-efficacy (6.7","[{'ForeName': 'Nathan C', 'Initials': 'NC', 'LastName': 'Nickel', 'Affiliation': 'Manitoba Centre for Health Policy, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Doupe', 'Affiliation': 'Manitoba Centre for Health Policy, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Enns', 'Affiliation': 'Manitoba Centre for Health Policy, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Marni', 'Initials': 'M', 'LastName': 'Brownell', 'Affiliation': 'Manitoba Centre for Health Policy, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Joykrishna', 'Initials': 'J', 'LastName': 'Sarkar', 'Affiliation': 'Manitoba Centre for Health Policy, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chateau', 'Affiliation': 'Manitoba Centre for Health Policy, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Burland', 'Affiliation': 'Manitoba Centre for Health Policy, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Mariette', 'Initials': 'M', 'LastName': 'Chartier', 'Affiliation': 'Manitoba Centre for Health Policy, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Katz', 'Affiliation': 'Manitoba Centre for Health Policy, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Crockett', 'Affiliation': 'George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Meghan B', 'Initials': 'MB', 'LastName': 'Azad', 'Affiliation': ""Children's Hospital Research Institute of Manitoba, Winnipeg, Manitoba, Canada.""}, {'ForeName': 'Jon M', 'Initials': 'JM', 'LastName': 'McGavock', 'Affiliation': ""Children's Hospital Research Institute of Manitoba, Winnipeg, Manitoba, Canada.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Santos', 'Affiliation': 'Healthy Child Manitoba Office, Manitoba Education and Training, Manitoba Government, Winnipeg, Manitoba, Canada.'}]",Maternal & child nutrition,['10.1111/mcn.13009']
2571,32815804,Dexamethasone added to levobupivacaine prolongs the duration of interscalene brachial plexus block and decreases rebound pain after arthroscopic rotator cuff repair.,"BACKGROUND


It has been reported that the addition of dexamethasone to interscalene brachial plexus block (ISBPB) prolongs the duration of the block effect. However, there have been no studies focusing on the effects of dexamethasone on rebound pain after the block effect has worn off. The aim of this study was to investigate the effect on postoperative pain when dexamethasone was added to ISBPB for arthroscopic rotator cuff repair (ARCR).
METHODS


In this multicenter, single-blinded, and randomized controlled study, 54 patients (33 males, 21 females) who received ARCR were randomly assigned to group L (ISBPB with 20 cc of 0.25% levobupivacaine; 21 patients) or group LD (ISBPB with 20 cc of 0.25% levobupivacaine + 3.3 mg dexamethasone; 33 patients). The primary outcome was the visual analog scale (VAS) for pain after the block effect had worn off. Secondary outcomes were the duration of analgesia, the time to the first request for additional analgesic, the number of additional doses of analgesic, and complications.
RESULTS


The VAS scores on postoperative days 0 and 1 were significantly lower in group LD than group L (P = .005, .035). This indicated that the rebound pain was relieved in group LD. After postoperative day 1, there was no significant difference in VAS score (P = .43 and .19 for days 2 and 3, respectively). The duration of analgesia was significantly longer in group LD than group L (P < .001). The time to the first request for additional analgesic was significantly longer in group LD than group L (P < .001). The number of additional doses of analgesic was significantly lower in group LD (P < .001).
CONCLUSION


In ARCR, the addition of dexamethasone to levobupivacaine not only prolongs the duration of ISBPB but also relieves rebound pain after the block effect wears off.",2020,The time to the first request for additional analgesic was significantly longer in group LD than group L (P < .001).,"['after arthroscopic rotator cuff repair', '54 patients (33 males, 21 females) who received ARCR']","['dexamethasone', 'group L (ISBPB with 20 cc of 0.25% levobupivacaine; 21 patients) or group LD (ISBPB with 20 cc of 0.25% levobupivacaine + 3.3 mg dexamethasone', 'Dexamethasone', 'levobupivacaine']","['VAS score', 'duration of analgesia', 'time to the first request for additional analgesic', 'duration of ISBPB', 'postoperative pain', 'duration of analgesia, the time to the first request for additional analgesic, the number of additional doses of analgesic, and complications', 'duration of interscalene brachial plexus block', 'visual analog scale (VAS) for pain', 'rebound pain', 'number of additional doses of analgesic', 'VAS scores']","[{'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0441846', 'cui_str': 'Group L'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517688', 'cui_str': '3.3'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",54.0,0.151078,The time to the first request for additional analgesic was significantly longer in group LD than group L (P < .001).,"[{'ForeName': 'Shuzo', 'Initials': 'S', 'LastName': 'Morita', 'Affiliation': 'Department of Orthopedic Surgery, Otemae Hospital, Osaka, Japan. Electronic address: shuzo0921@gmail.com.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Oizumi', 'Affiliation': 'Upper Extremity Center of Joint Replacement and Endoscopic Surgery, Hokushin Orthopedic Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Suenaga', 'Affiliation': 'Upper Extremity Center of Joint Replacement and Endoscopic Surgery, Hokushin Orthopedic Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Chika', 'Initials': 'C', 'LastName': 'Yoshioka', 'Affiliation': 'Upper Extremity Center of Joint Replacement and Endoscopic Surgery, Hokushin Higashi Orthopedic Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Yamane', 'Affiliation': 'Upper Extremity Center of Joint Replacement and Endoscopic Surgery, Hokushin Higashi Orthopedic Hospital, Sapporo, Hokkaido, Japan.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Orthopedic Surgery, Nara Medical University, Nara, Japan.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.04.019']
2572,32811485,Virtual versus jaw simulation in Oral implant education: a randomized controlled trial.,"BACKGROUND


This research aims to investigate the evaluation methods of teaching oral implant clinical courses and estimate the effectiveness of a virtual simulation platform.
METHODS


Eighty second- and third-year undergraduates in Lanzhou University were recruited and randomized to either three experimental groups or one control group. The subjects undertook theoretical examinations to test their basic level of knowledge after training in similarly unified knowledge courses. Each student group then participated in an eight-hour operating training session. An operation test on pig mandible was conducted, followed by a second theoretical examination. The assessment consists of three distinct parts: a subjective operating score by a clinical senior teacher, an implant accuracy analysis in cone-beam computed tomography (angular, apical, and entrance deviation), and comparison of the two theoretical examinations. Finally, students completed a questionnaire gauging their understanding of the virtual simulation.
RESULTS


There was no significant difference between the four groups in first theoretical examination (P > 0.05); the second theoretical scores of the V-J and J-V group (62.90 ± 3.70, 60.05 ± 2.73) were significantly higher than the first time (57.05 ± 3.92, P < 0.05), while no difference between the V (57.10 ± 3.66) and J (56.89 ± 2.67) groups was found. Thus, the combination of V-J was effective in improving students' theoretical scores. The V-J and J-V groups had higher scores on operation (73.98 ± 4.58, 71.85 ± 4.67) and showed better implant precision.
CONCLUSION


Virtual simulation education, especially with a jaw simulation model, could improve students' implantology achievements and training. Currently study found that the V-J group may performed better than the J-V group in oral implant teaching.",2020,"There was no significant difference between the four groups in first theoretical examination (P > 0.05); the second theoretical scores of the V-J and J-V group (62.90 ± 3.70, 60.05 ± 2.73) were significantly higher than the first time (57.05 ± 3.92, P < 0.05), while no difference between the V (57.10 ± 3.66) and J (56.89 ± 2.67) groups was found.",['Eighty second- and third-year undergraduates in Lanzhou University'],['Virtual versus jaw simulation in Oral implant education'],[],"[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0441366', 'cui_str': 'Jaw implant'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],80.0,0.0261387,"There was no significant difference between the four groups in first theoretical examination (P > 0.05); the second theoretical scores of the V-J and J-V group (62.90 ± 3.70, 60.05 ± 2.73) were significantly higher than the first time (57.05 ± 3.92, P < 0.05), while no difference between the V (57.10 ± 3.66) and J (56.89 ± 2.67) groups was found.","[{'ForeName': 'Baoping', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'School of Stomatology Lanzhou University, Lanzhou, 730000, China.'}, {'ForeName': 'Sihong', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'School of Stomatology Lanzhou University, Lanzhou, 730000, China.'}, {'ForeName': 'Shuting', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'School of Stomatology Lanzhou University, Lanzhou, 730000, China.'}, {'ForeName': 'Mingfang', 'Initials': 'M', 'LastName': 'Hou', 'Affiliation': 'College of Medicine, Lanzhou University, Lanzhou, 730000, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'School of Stomatology Lanzhou University, Lanzhou, 730000, China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'School of Stomatology Lanzhou University, Lanzhou, 730000, China.'}, {'ForeName': 'Yiting', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'School of Stomatology Lanzhou University, Lanzhou, 730000, China.'}, {'ForeName': 'Yumeng', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'School of Stomatology Lanzhou University, Lanzhou, 730000, China.'}, {'ForeName': 'Errui', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'School of Stomatology Lanzhou University, Lanzhou, 730000, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Cao', 'Affiliation': 'School of Stomatology Lanzhou University, Lanzhou, 730000, China.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': 'School of Stomatology Lanzhou University, Lanzhou, 730000, China.'}, {'ForeName': 'Ruiping', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': 'School of Stomatology Lanzhou University, Lanzhou, 730000, China.'}, {'ForeName': 'Kailiang', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'School of Stomatology Lanzhou University, Lanzhou, 730000, China. zhangkllzu@163.com.'}]",BMC medical education,['10.1186/s12909-020-02152-y']
2573,32811613,Transcranial Pulsed Ultrasound with Alteplase Intravenous Thrombolysis for Vascular Recanalisation in Acute Ischemic Stroke.,"The objective of study was to investigate the effect of transcranial pulsed ultrasound combined with alteplase on treatment of vascular recanalisation in acute ischemic stroke patients. Eighty-two patients were randomly divided equally into two groups. Group A was treated with transcranial pulsed ultrasound combined with alteplase intravenous thrombolysis. Group B received alteplase intravenous thrombolytic treatment. At 2 and 24 hours after treatment, National Institutes of Health Stroke Scale (NIHSS) score of group A was lower than that of group B (both p<0.001), and vascular recanalisation rate of patients in group A was higher than that of group B (p=0.004, and 0.002 respectively). At 90 days after treatment, rate of favourable prognosis [(modified rankin scale (mRS) ≤2 points)] of group A was higher than that of group B (p=0.001). Transcranial pulsed ultrasound combined with alteplase intravenous thrombolytic treatment can improve vascular recanalization rate and prognosis. Key Words: Transcranial pulsed ultrasound, Acute ischemic stroke, Alteplase, Thrombolysis, Vascular recanalisation.",2020,Transcranial pulsed ultrasound combined with alteplase intravenous thrombolytic treatment can improve vascular recanalization rate and prognosis.,"['acute ischemic stroke patients', 'Acute Ischemic Stroke', 'Eighty-two patients']","['alteplase intravenous thrombolytic treatment', 'transcranial pulsed ultrasound combined with alteplase', 'Transcranial Pulsed Ultrasound with Alteplase Intravenous Thrombolysis', 'transcranial pulsed ultrasound combined with alteplase intravenous thrombolysis']","['vascular recanalisation rate', 'vascular recanalization rate and prognosis', 'Transcranial pulsed ultrasound, Acute ischemic stroke, Alteplase, Thrombolysis, Vascular recanalisation', 'National Institutes of Health Stroke Scale (NIHSS) score', 'rate of favourable prognosis [(modified rankin scale']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816958', 'cui_str': '80'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0016018', 'cui_str': 'Thrombolytic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C2143225', 'cui_str': 'Pulsed Ultrasound'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0034771', 'cui_str': 'Recanalization'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C2143225', 'cui_str': 'Pulsed Ultrasound'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",82.0,0.0246561,Transcranial pulsed ultrasound combined with alteplase intravenous thrombolytic treatment can improve vascular recanalization rate and prognosis.,"[{'ForeName': 'Zhenghong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'EEG Room, Linyi Central Hospital of Shandong Province, China.'}, {'ForeName': 'Jingyu', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of General Surgery, Linyi Central Hospital of Shandong Province, China.'}]",Journal of the College of Physicians and Surgeons--Pakistan : JCPSP,['10.29271/jcpsp.2020.07.765']
2574,32811623,A randomized comparison of extended-release naltrexone with or without patient navigation vs enhanced treatment-as-usual for incarcerated adults with opioid use disorder.,"The high prevalence of opioid use among justice-involved adults make jails an exceptional setting to initiate opioid use disorder (OUD) treatment, but optimal strategies for delivering these interventions are still not well understood. The objective of this study was to conduct a randomized controlled trial to assess the effectiveness of extended-release naltrexone (XR-NTX, Vivitrol®; Alkermes Inc) alone or in conjunction with patient navigation (XR-NTX + PN) for jail inmates with OUD. We randomized a sample of 135 sentenced jail inmates with moderate to severe OUD to (1) XR-NTX only; (2) XR-NTX + PN; or (3) enhanced treatment-as-usual (ETAU) with drug education, each initiated prior to release from jail. We scheduled follow-up data assessments at 1, 3, 6, and 12 months post-release. Primary outcomes were opioid use (based on Timeline Followback Interview and Addiction Severity Index) and meeting CIDI DSM-5 criteria for OUD 6 months postrelease. We also measured treatment adherence, HIV risk, and recidivism. XR-NTX participants received a mean of 2.26 of 7 possible injections compared to XR-NTX + PN participants, who received a mean of 2.93 injections (Cohen's d = 0.33, 95% CI: -0.09 to 0.74). Thirty-six percent of patients in XR-NTX + PN attended at least one postrelease PN session. We found no significant differences by study condition six months after release from jail for the primary outcomes of any opioid use (ETAU: 17%, XR-NTX: 16%, XR-NTX + PN: 29%) and past 30-day OUD (ETAU: 8%, XR-NTX: 11%, XR-NTX + PN: 10%). Secondary outcomes of rearrest and HIV risk also were similar across groups, with the exception of lower sex-related HIV risk among those in the XR-NTX condition at 12 months. This study did not show superior outcomes of XR-NTX or XR-NTX + PN with regard to opioid use or recidivism outcomes, relative to ETAU. It did, however, highlight the difficulties with adherence to XR-NTX and PN interventions in OUD patients initiating treatment in jail.",2020,"We found no significant differences by study condition six months after release from jail for the primary outcomes of any opioid use (ETAU: 17%, XR-NTX: 16%, XR-NTX + PN: 29%) and past 30-day OUD (ETAU: 8%, XR-NTX: 11%, XR-NTX + PN: 10%).","['incarcerated adults with opioid use disorder', '135 sentenced jail inmates with moderate to severe OUD to (1) XR-NTX only; (2) XR-NTX\xa0+\xa0PN; or (3) enhanced treatment-as-usual (ETAU) with drug education, each initiated prior to release from jail', 'OUD patients initiating treatment in jail', 'jail inmates with OUD']","['extended-release naltrexone with or without patient navigation vs enhanced treatment-as-usual for', 'extended-release naltrexone (XR-NTX, Vivitrol®', 'patient navigation (XR-NTX\xa0+\xa0PN']","['treatment adherence, HIV risk, and recidivism', 'rearrest and HIV risk', 'opioid use (based on Timeline Followback Interview and Addiction Severity Index) and meeting CIDI DSM-5 criteria for OUD 6\xa0months postrelease']","[{'cui': 'C0392751', 'cui_str': 'In prison'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0542304', 'cui_str': 'Medication education'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C1712071', 'cui_str': 'Vivitrol'}]","[{'cui': 'C4505265', 'cui_str': 'Therapeutic Adherence'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0680458', 'cui_str': 'Recidivism'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0450981', 'cui_str': 'Addiction severity index'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}, {'cui': 'C0451085', 'cui_str': 'Composite international diagnostic interview'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",135.0,0.0582878,"We found no significant differences by study condition six months after release from jail for the primary outcomes of any opioid use (ETAU: 17%, XR-NTX: 16%, XR-NTX + PN: 29%) and past 30-day OUD (ETAU: 8%, XR-NTX: 11%, XR-NTX + PN: 10%).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Farabee', 'Affiliation': 'Department of Population Health, New York University; 180 Madison Ave, 17(th) Floor, New York, NY 10016, United States of America. Electronic address: David.Farabee@nyulangone.org.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Condon', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, 2650 Yale Blvd. SE, Albuquerque, NM 87106, United States of America.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Hallgren', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, UW Medical Center, Box 356560, 1959 NE Pacific St., Seattle, WA 98195, United States of America.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'McCrady', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, 2650 Yale Blvd. SE, Albuquerque, NM 87106, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108076']
2575,32811625,Temporal dynamics of the relationship between change in depressive symptoms and cannabis use in adolescents receiving psychosocial treatment for cannabis use disorder.,"AIMS


Cannabis use disorder (CUD) and depression frequently co-occur in youth. How depressive symptoms change over the course of CUD treatment and how they impact substance use treatment outcomes is unknown. In the current study, we examine the temporal relationships between cannabis use and depression in adolescents receiving evidence-based treatments for CUD as part of a multisite clinical trial.
DESIGN


Six hundred adolescents (age 12-18) with a CUD were randomly assigned to substance use treatment from one of five evidence-based psychosocial interventions. We assessed self-reported cannabis use frequency and depressive symptoms at baseline (BL) and again at 3-, 6-, 9, and 12-months. A bivariate latent change model assessed bidirectional effects of baseline levels and time-lagged changes in depressive symptoms and cannabis use on depression and cannabis use outcomes.
FINDINGS


Depressive symptoms (72%) and major depressive disorder (MDD) (18%) were common at BL. Both depression and cannabis use decreased over time and change in cannabis use was significantly associated with change in depressive symptoms (b = 1.22, p = .003). Time-lag analyses showed that within-subject change in depression (from one time point to the next) was predicted by previous depression (b = -0.71, p < .001) but not cannabis use (p = .068), and change (decrease) in cannabis use was predicted by previous (greater) depressive symptoms (b = -1.47, p < .001) but not cannabis use (p = .158), respectively.
CONCLUSION


These findings indicate an enduring relationship between decreasing cannabis use and decreasing depression among adolescents lasting for 9-months after receiving psychosocial interventions for CUD. The presence of depressive symptoms did not appear to interfere with substance use treatment or attenuate improvements in cannabis use frequency. A decrease in cannabis use was not contingent upon a reduction in depressive symptoms. These findings are limited by the possibility of regression to the mean for both cannabis use and depressive symptoms, and the lack of a nonintervention control group.",2020,"Both depression and cannabis use decreased over time and change in cannabis use was significantly associated with change in depressive symptoms (b = 1.22, p = .003).","['adolescents receiving psychosocial treatment for cannabis use disorder', 'adolescents receiving evidence-based treatments for CUD as part of a multisite clinical trial', 'Six hundred adolescents (age 12-18) with a CUD']",[],"['major depressive disorder (MDD', 'depression', 'depressive symptoms', 'Depressive symptoms']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0001779', 'cui_str': 'Age'}]",[],"[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",600.0,0.127233,"Both depression and cannabis use decreased over time and change in cannabis use was significantly associated with change in depressive symptoms (b = 1.22, p = .003).","[{'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Arias', 'Affiliation': 'Virginia Commonwealth University, United States of America. Electronic address: albert.arias@vcuhealth.edu.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Hammond', 'Affiliation': 'Johns Hopkins University School of Medicine, United States of America. Electronic address: chammo20@jhmi.edu.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Burleson', 'Affiliation': 'University of Connecticut School of Medicine, United States of America. Electronic address: burleson@uchc.edu.'}, {'ForeName': 'Yifrah', 'Initials': 'Y', 'LastName': 'Kaminer', 'Affiliation': 'University of Connecticut School of Medicine, United States of America. Electronic address: kaminer@uchc.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Feinn', 'Affiliation': 'Quinnipiac University School of Medicine, United States of America. Electronic address: richard.feinn@quinnipiac.edu.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Curry', 'Affiliation': 'Duke University School of Medicine, United States of America. Electronic address: john.curry@duke.edu.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Dennis', 'Affiliation': 'Chestnut Health Systems, United States of America. Electronic address: mdennis@chestnut.org.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108087']
2576,32811628,A randomized clinical trial of smartphone self-managed recovery support services.,"This study examines the effectiveness of smartphone-based ecological momentary interventions (EMI) and assessments (EMA), delivered separately and combined, to provide recovery support following substance use disorder (SUD) treatment engagement. We recruited adults (N = 401) from SUD treatment programs in Chicago and, after engagement for at least two sessions, nights, or medication dosages, we randomly assigned them to one of four conditions that lasted 6 months: (1) EMI only, (2) EMA only, (3) both EMI and EMA, and (4) control condition of neither EMI nor EMA. EMIs provided support for recovery through applications on the phone or links to other resources; EMAs were delivered randomly 5 times per day asking participants to indicate recent substance use and situational risk and protective factors. The primary dependent variable was days of abstinence in the 6 months following study intake. Rates of EMI and EMA utilization indicated high compliance, although EMI use decreased over time. There was a small direct effect of time across conditions (F (2,734)  = 4.33, p = .014, Cohen's f = 0.11) and a small direct effect of time-by-EMI use (F (2,734)  = 4.85, p = .009, f = 0.11) on days of abstinence. There was no significant direct effect of time-by-EMAs nor interaction effect of time-by-EMI-by-EMA. However, secondary path model analyses showed a small but significant indirect effect of EMA on abstinence via EMI use. Stepwise modeling identified a simplified model based on the proportion of weeks using ≥1 EMI and the EMI to listen to music, which predicted 7.2% of the variance in days of abstinence (F (2,195,)  = 7.56, p < .001). Combined delivery of EMI and EMA shows potential for increasing abstinence above and beyond the effect of SUD treatment engagement and for addressing the limited national capacity for recovery support.",2020,There was no significant direct effect of time-by-EMAs nor interaction effect of time-by-EMI-by-EMA.,"['recruited adults (N\xa0=\xa0401) from SUD treatment programs in Chicago and, after engagement for at least two sessions, nights, or medication dosages']","['EMI and EMA', 'smartphone self-managed recovery support services', 'smartphone-based ecological momentary interventions (EMI) and assessments (EMA', 'EMA']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0268596', 'cui_str': 'Glutaric aciduria, type 2'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",[],,0.0453708,There was no significant direct effect of time-by-EMAs nor interaction effect of time-by-EMI-by-EMA.,"[{'ForeName': 'Christy K', 'Initials': 'CK', 'LastName': 'Scott', 'Affiliation': 'Chestnut Health Systems, 221 W. Walton St., Chicago, IL 60610, United States of America. Electronic address: cscott@chestnut.org.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Dennis', 'Affiliation': 'Chestnut Health Systems, 448 Wylie Dr., Normal, IL 61761, United States of America. Electronic address: mdennis@chestnut.org.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Johnson', 'Affiliation': 'University of South Florida, 4202 E. Fowler Ave., Tampa, FL 33620, United States of America. Electronic address: kjohnson33@usf.edu.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Grella', 'Affiliation': 'Chestnut Health Systems, 221 W. Walton St., Chicago, IL 60610, United States of America. Electronic address: cegrella@chestnut.org.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108089']
2577,32811629,Factors associated with withdrawal symptoms and anger among people resuscitated from an opioid overdose by take-home naloxone: Exploratory mixed methods analysis.,"INTRODUCTION


Take-home naloxone (THN) is a clinically effective and cost-effective means of reducing opioid overdose fatality. Nonetheless, naloxone administration that successfully saves a person's life can still produce undesirable and harmful effects.
AIM


To better understand factors associated with two widely reported adverse outcomes following naloxone administration; namely the person resuscitated displays: i. withdrawal symptoms and ii. anger.
METHODS


A mixed methods study combining a randomized controlled trial of overdose education and naloxone prescribing to people with opioid use disorder and semi-structured qualitative interviews with trial participants who had responded to an overdose whilst in the trial. All data were collected in New York City (2014-2019). A dataset (comprising demographic, pharmacological, situational, interpersonal, and overdose training related variables) was generated by transforming qualitative interview data from 47 overdose events into dichotomous variables and then combining these with quantitative demographic and overdose training related data from the main trial. Associations between variables within the dataset and reports of: i. withdrawal symptoms and ii. anger were explored using chi-squared tests, t-tests, and logistic regressions.
RESULTS


A multivariate logistic regression found that people who had overdosed were significantly more likely to display anger if the person resuscitating them criticized, berated or chastised them during resuscitation (adjusted OR = 27 [95% CI = 4.0-295]). In contrast, they were significantly less likely to display anger if the person resuscitating them communicated positively with them (OR = 0.10 [95% CI = 0.01-0.78]). Both positive and negative communication styles were independently associated with anger, and communication was associated with 59% of the variance in anger. There was no evidence that people who displayed withdrawal symptoms were more likely to display anger than those not displaying withdrawal symptoms, and neither displaying withdrawal symptoms nor displaying anger were associated with using more drugs after resuscitation.
CONCLUSIONS


Contrary to common assumptions, withdrawal symptoms and anger following naloxone administration may be unrelated phenomena. Findings are consistent with previous research that has suggested that a lay responder's positive or reassuring communication style may lessen anger post overdose. Implications for improving THN programmes and naloxone administration are discussed.",2020,"There was no evidence that people who displayed withdrawal symptoms were more likely to display anger than those not displaying withdrawal symptoms, and neither displaying withdrawal symptoms nor displaying anger were associated with using more drugs after resuscitation.
","['people with opioid use disorder and semi-structured qualitative interviews with trial participants who had responded to an overdose whilst in the trial', 'person resuscitated displays']","['overdose education and naloxone', 'naloxone (THN', 'naloxone']",['withdrawal symptoms'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C2587207', 'cui_str': 'For resuscitation'}]","[{'cui': 'C0029944', 'cui_str': 'Drug overdose'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0027358', 'cui_str': 'Naloxone'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}]",,0.126341,"There was no evidence that people who displayed withdrawal symptoms were more likely to display anger than those not displaying withdrawal symptoms, and neither displaying withdrawal symptoms nor displaying anger were associated with using more drugs after resuscitation.
","[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Neale', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, United Kingdom; Centre for Social Research in Health, University of New South Wales, Sydney, NSW 2052, Australia; South London and Maudsley NHS Foundation Trust, Camberwell, London, SE5 8AZ, United Kingdom. Electronic address: joanne.neale@kcl.ac.uk.""}, {'ForeName': 'Nicola J', 'Initials': 'NJ', 'LastName': 'Kalk', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, United Kingdom; South London and Maudsley NHS Foundation Trust, Camberwell, London, SE5 8AZ, United Kingdom. Electronic address: nicola.kalk@kcl.ac.uk.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Parkin', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, United Kingdom. Electronic address: stephen.parkin@kcl.ac.uk.""}, {'ForeName': 'Caral', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, United Kingdom. Electronic address: caral.brown@kcl.ac.uk.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Brandt', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: lb3227@cumc.columbia.edu.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: anc2002@cumc.columbia.edu.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Castillo', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: felipe.castillo@nyspi.columbia.edu.'}, {'ForeName': 'Jermaine D', 'Initials': 'JD', 'LastName': 'Jones', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: jermaine.jones@nyspi.columbia.edu.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""National Addiction Centre, King's College London, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, United Kingdom; South London and Maudsley NHS Foundation Trust, Camberwell, London, SE5 8AZ, United Kingdom. Electronic address: john.strang@kcl.ac.uk.""}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Division on Substance Use Disorders, Columbia University Irving Medical Center and New York State Psychiatric Institute, 1051 Riverside Drive, Unit 120, New York, NY 10032, United States. Electronic address: sdc10@cumc.columbia.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108099']
2578,32811715,Final Analysis of the Ipilimumab Versus Placebo Following Radiotherapy Phase III Trial in Postdocetaxel Metastatic Castration-resistant Prostate Cancer Identifies an Excess of Long-term Survivors.,"BACKGROUND


The phase 3 trial CA184-043 evaluated radiotherapy to bone metastases followed by Ipilimumab or placebo in men with metastatic castrate-resistant prostate cancer (mCRPC) who had received docetaxel previously. In a prior analysis, the trial's primary endpoint (overall survival [OS]) was not improved significantly.
OBJECTIVE


To report the final analysis of OS.
DESIGN, SETTING, AND PARTICIPANTS


A total of 799 patients were randomized to receive a single dose of radiotherapy to one or more bone metastases followed by either Ipilimumab (n = 399) or placebo (n = 400).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


OS was analyzed in the intention-to-treat population. Prespecified and exploratory subset analyses based on Kaplan-Meier/Cox methodology were performed.
RESULTS AND LIMITATIONS


During an additional follow-up of approximately 2.4 yr since the primary analysis, 721/799 patients have died. Survival analysis showed crossing of the curves at 7-8 mo, followed by persistent separation of the curves beyond that point, favoring the ipilimumab arm. Given the lack of proportional hazards, a piecewise hazard model showed that the hazard ratio (HR) changed over time: the HR was 1.49 (95% confidence interval 1.12, 1.99) for 0-5 mo, 0.66 (0.51, 0.86) for 5-12 mo, and 0.66 (0.52, 0.84) beyond 12 mo. OS rates were higher in the ipilimumab versus placebo arms at 2 yr (25.2% vs 16.6%), 3 yr (15.3% vs 7.9%), 4 yr (10.1% vs 3.3%), and 5 yr (7.9% vs. 2.7%). Disease progression was the most frequent cause of death in both arms. In seven patients (1.8%) in the ipilimumab arm and one (0.3%) in the placebo arm, the primary cause of death was reported as study drug toxicity. No long-term safety signals were identified.
CONCLUSIONS


In this preplanned long-term analysis, OS favored ipilimumab plus radiotherapy versus placebo plus radiotherapy for patients with postdocetaxel mCRPC. OS rates at 3, 4, and 5 yr were approximately two to three times higher than those in the ipilimumab arm.
PATIENT SUMMARY


After longer follow-up, survival favored the group of men who received ipilimumab, with overall survival rates being two to three times higher at 3 yr and beyond.",2020,"After longer follow-up, survival favored the group of men who received ipilimumab, with overall survival rates being two to three times higher at 3 yr and beyond.","['patients with postdocetaxel mCRPC', 'A total of 799 patients', 'men with metastatic castrate-resistant prostate cancer (mCRPC) who had received docetaxel previously']","['radiotherapy to one or more bone metastases followed by either Ipilimumab', 'Ipilimumab Versus Placebo', 'ipilimumab plus radiotherapy', 'placebo plus radiotherapy', 'Ipilimumab or placebo', 'ipilimumab', 'placebo']","['OS rates', 'death', 'survival', 'hazard ratio (HR', 'study drug toxicity', 'overall survival rates', 'overall survival [OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1328504', 'cui_str': 'Hormone refractory prostate cancer'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",799.0,0.666508,"After longer follow-up, survival favored the group of men who received ipilimumab, with overall survival rates being two to three times higher at 3 yr and beyond.","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Gustave Roussy, University of Paris Sud, Villejuif, France. Electronic address: karim.fizazi@gustaveroussy.fr.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'Columbia University Herbert Irving Comprehensive Cancer Center, New York, NY, USA.'}, {'ForeName': 'Tomasz M', 'Initials': 'TM', 'LastName': 'Beer', 'Affiliation': 'Oregon Health & Science University Knight Cancer Institute, Portland, OR, USA.'}, {'ForeName': 'Eugene D', 'Initials': 'ED', 'LastName': 'Kwon', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Howard I', 'Initials': 'HI', 'LastName': 'Scher', 'Affiliation': 'Memorial Sloan-Kettering Cancer Center, New York, NY, USA; Weill-Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Winald R', 'Initials': 'WR', 'LastName': 'Gerritsen', 'Affiliation': 'Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bossi', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Alfons J M van', 'Initials': 'AJMV', 'LastName': 'den Eertwegh', 'Affiliation': 'VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Krainer', 'Affiliation': 'Vienna General Hospital (AKH Wien), Wien, Austria.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Houede', 'Affiliation': 'CHU of Nimes, Nimes, France; Montpellier University, Montpellier, France.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Santos', 'Affiliation': 'Centro Médico Austral, Buenos Aires, Argentina.'}, {'ForeName': 'Hakim', 'Initials': 'H', 'LastName': 'Mahammedi', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Ng', 'Affiliation': 'St John Of God Hospital, Subiaco, Australia.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Danielli', 'Affiliation': 'University Hospital of Siena, Istituto Toscano Tumori, Siena, Italy.'}, {'ForeName': 'Fabio A', 'Initials': 'FA', 'LastName': 'Franke', 'Affiliation': 'Hospital de Caridade de Ijuí, Ijuí, Brazil.'}, {'ForeName': 'Santhanam', 'Initials': 'S', 'LastName': 'Sundar', 'Affiliation': 'Nottingham University Hospitals NHS Trust, Nottingham, UK.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'André M', 'Initials': 'AM', 'LastName': 'Bergman', 'Affiliation': 'The Netherlands Cancer Institute and Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Tudor E', 'Initials': 'TE', 'LastName': 'Ciuleanu', 'Affiliation': 'Institute of Oncology Ion Chiricuta, Cluj-Napoca, Romania.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Korbenfeld', 'Affiliation': 'Hospital Britanico de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sengeløv', 'Affiliation': 'Herlev Hospital, Region Hovedstadens Apotek, Herlev, Denmark.'}, {'ForeName': 'Steinbjorn', 'Initials': 'S', 'LastName': 'Hansen', 'Affiliation': 'Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'M Brent', 'Initials': 'MB', 'LastName': 'McHenry', 'Affiliation': 'Bristol-Myers Squibb Company, Wallingford, CT, USA.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Bristol-Myers Squibb Company, Wallingford, CT, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Logothetis', 'Affiliation': 'The University of Texas M. D. Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European urology,['10.1016/j.eururo.2020.07.032']
2579,32811738,"A single one-minute, comfortable paced, stair-climbing bout reduces postprandial glucose following a mixed meal.","BACKGROUND AND AIMS


Postprandial blood glucose (PBG) is an independent predictor of disease and mortality risk. To date, the shortest, single, moderate-intensity exercise intervention to reduce PBG is a 1 min bout of stair stepping during an oral glucose tolerance test. Whether this effect translates to real meal consumption is unknown.
METHODS AND RESULTS


Subjects (N = 30) participated in a randomized controlled crossover trial performing 0 min (seated control), 1 min, 3 min or 10 min of stair climbing and descending bouts (SCD) at a self-selected pace after consumption of a mixed meal on four separate visits. Compared to control, all SCD reduced PBG at least one timepoint: at 30-min the 3 min (-10.8 (-18.7 to -2.8) mg/dL, p = 0.010) and 10 min (-36.3 (-46.4 to -26.3) mg/dL), p < .001), and at 45-min the 1 min (-7.3 (-13.9 to -0.7) mg/dL, p = 0.030, 3 min (-8.7 (-13.9 to -3.6) mg/dL, p = 0.002 and 10 min SCD (-12.2 (-18.2 to -6.1)mg/dL, p < 0.000) reduced PBG. The area under the curve (AUC) for PBG was lower following the 3 min (-4.4% (-7.5 to -1.4%), p = 0.006) and 10 min (-8.9% (-12.4 to -5.3%), p < 0.001), while the incremental AUC (iAUC) was reduced only following the 10 min (-38.0% (-63.7 to -12.3%), p = 0.005) SCD. All SCD were rated by subjects as very light to light intensity.
CONCLUSIONS


Single, subjectively ""light"" intensity stair climbing and descending bouts as short as 1 min in duration attenuate the postprandial glucose response in normal weight individuals following consumption of a mixed meal. More pronounced effects require longer bouts in a dose-dependent manner.",2020,"The area under the curve (AUC) for PBG was lower following the 3 min (-4.4% (-7.5 to -1.4%), p = 0.006) and 10 min (-8.9% (-12.4 to -5.3%), p < 0.001), while the incremental AUC (iAUC) was reduced only following the 10 min (-38.0% (-63.7 to -12.3%), p = 0.005)",['Subjects (N\xa0=\xa030'],"['0 min (seated control), 1\xa0min, 3\xa0min or 10\xa0min of stair climbing and descending bouts (SCD) at a self-selected pace after consumption of a mixed meal on four separate visits']","['Postprandial blood glucose (PBG', 'SCD', 'SCD reduced PBG', 'PBG', 'postprandial glucose', 'area under the curve (AUC) for PBG', 'incremental AUC (iAUC']",[],"[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1290942', 'cui_str': 'Climbing stairs'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0443299', 'cui_str': 'Separate'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",30.0,0.0429009,"The area under the curve (AUC) for PBG was lower following the 3 min (-4.4% (-7.5 to -1.4%), p = 0.006) and 10 min (-8.9% (-12.4 to -5.3%), p < 0.001), while the incremental AUC (iAUC) was reduced only following the 10 min (-38.0% (-63.7 to -12.3%), p = 0.005)","[{'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, USA. Electronic address: Jmoore714@gmail.com.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Salmons', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Vinoskey', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, USA.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Kressler', 'Affiliation': 'School of Exercise and Nutritional Sciences, San Diego State University, San Diego, CA, 92182-7251, USA.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.06.020']
2580,32811740,Self-management education may improve blood pressure in people with type 2 diabetes. A randomized controlled clinical trial.,"BACKGROUND AND AIMS


Diabetes is a suitable model to evaluate intervention programmes aimed at chronic diseases, because of its well-defined and measurable process and outcome indicators. In this study, we aimed at investigating the effects of group based self-management education on clinical and psychological variables in type 2 diabetes.
METHODS AND RESULTS


Four-year randomized controlled clinical trial (ISRCTN14558376) comparing Group Care and traditional one-to-one care. Clinical and psychological variables were monitored at baseline, 2 and 4 years. Although differences between groups appear to be non-significant at univariate analysis, body weight, BMI and HbA1c, systolic and diastolic blood pressure improved in the patients followed by Group Care but not among Controls. Prescription of lipid-lowering and anti-hypertensive agents did not change among the patients on Group Care, whereas anti-hypertensives were stepped up among Controls without improving their blood pressure. Multivariable analysis suggests that blood pressure improvement among patients on Group Care was independent of BMI, duration of diabetes and antihypertensive medication, suggesting a direct effect of education, presumably by increasing adherence. The ""Powerful Others"" dimension of the Locus of Control worsened and fear of complications decreased among Controls.
CONCLUSIONS


The results confirm that a multidisciplinary structured group educational approach improves blood pressure, presumably through better adherence to healthy lifestyle and medication, in people with type 2 diabetes.
CLINICAL TRIAL REGISTRATION NUMBER


ISRCTN14558376.",2020,"Although differences between groups appear to be non-significant at univariate analysis, body weight, BMI and HbA1c, systolic and diastolic blood pressure improved in the patients followed by Group Care but not among Controls.","['type 2 diabetes', 'people with type 2 diabetes']","['lipid-lowering and anti-hypertensive agents', 'Self-management education', 'group based self-management education', 'Group Care and traditional one-to-one care']","['fear of complications', 'blood pressure', 'blood pressure improvement', 'body weight, BMI and HbA1c, systolic and diastolic blood pressure']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0581567', 'cui_str': 'One to one care'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",,0.059892,"Although differences between groups appear to be non-significant at univariate analysis, body weight, BMI and HbA1c, systolic and diastolic blood pressure improved in the patients followed by Group Care but not among Controls.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Trento', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy. Electronic address: marina.trento@unito.it.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fornengo', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Amione', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Salassa', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Barutta', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Gruden', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Mazzeo', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Merlo', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Chiesa', 'Affiliation': 'Links Foundation, Polytechnic University of Turin, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Cavallo', 'Affiliation': 'Department of Public Health and Paediatric Sciences, University of Turin, Italy.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'Charrier', 'Affiliation': 'Department of Public Health and Paediatric Sciences, University of Turin, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Porta', 'Affiliation': 'Laboratory of Clinical Pedagogy, Department of Medical Sciences, University of Turin, Italy.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.06.023']
2581,32811741,Alternative treatment with Johrei: A controlled randomized study evaluating seed physiological potential.,"BACKGROUND


Johrei, a noncontact healing therapy that purportedly channels ""universal energy"", is an easily taught technique with numerous positive reports of healing in human trials. However, studies on humans have been limited by small sample sizes, the placebo effect and baseline differences between groups. Overcoming some of these limitations, this study evaluated the effect of Johrei on the physiological potential of lettuce seeds.
METHODS


Lettuce seeds were subjected to thermal stress and then treated with Johrei before and after two years of storage. The seedling emergence percentage, emergence speed index, classification score, percentage of viable seedlings and root and shoot dry mass of the treated seeds were determined.
RESULTS


Stress-treated seeds treated with Johrei had a greater seedling emergence percentage than those not treated with Johrei (p<0.0001). Johrei also resulted in a greater emergence speed index (p<0.0001), a higher percentage of viable seedlings with higher classification score (p<0.0001) and greater root and shoot dry mass regardless of the storage duration (p<0.0001).
CONCLUSIONS


Johrei effectively preserved lettuce seed health, and the efficacy of Johrei can be assessed by evaluating its effects on the physiological potential of stress-treated seeds. Using live plants allows the influence of Johrei to be evaluated without interference from the placebo effect. Future studies should evaluate the influence of Johrei in primary aging processes in plants, such as cellular respiration by mitochondrial analysis, to gain insight into Johrei's mechanisms of action and enable inferences regarding similar cellular-level processes that occur in humans.",2020,"Johrei also resulted in a greater emergence speed index (p<0.0001), a higher percentage of viable seedlings with higher classification score (p<0.0001) and greater root and shoot dry mass regardless of the storage duration (p<0.0001).
",[],['Johrei'],"['seedling emergence percentage, emergence speed index, classification score, percentage of viable seedlings and root and shoot dry mass of the treated seeds', 'emergence speed index']",[],[],"[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0242437', 'cui_str': 'Seedling'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}]",,0.0845452,"Johrei also resulted in a greater emergence speed index (p<0.0001), a higher percentage of viable seedlings with higher classification score (p<0.0001) and greater root and shoot dry mass regardless of the storage duration (p<0.0001).
","[{'ForeName': 'Márcia P B X', 'Initials': 'MPBX', 'LastName': 'de Melo', 'Affiliation': 'Korin Agricultura e Meio Ambiente Ltda., Estrada Municipal de Camaquã, sn, Caixa Postal 033, CEP: 13537-000, Ipeúna, SP, Brazil. Electronic address: marcia.xavier@korinagricultura.com.br.'}, {'ForeName': 'Carlos Daniel de S', 'Initials': 'CDS', 'LastName': 'Rodrigues', 'Affiliation': 'Church of World Messianity of Brazil, Rua Morgado de Mateus, 77, Vila Mariana, CEP: 04515-050, São Paulo, SP, Brazil. Electronic address: daniel.rodrigues@messianica.org.br.'}, {'ForeName': 'Domiedson A', 'Initials': 'DA', 'LastName': 'Dos Santos', 'Affiliation': 'Korin Agricultura e Meio Ambiente Ltda., Estrada Municipal de Camaquã, sn, Caixa Postal 033, CEP: 13537-000, Ipeúna, SP, Brazil. Electronic address: domiedson.santos@korinagricultura.com.br.'}, {'ForeName': 'Jorge Konrado Xavier', 'Initials': 'JKX', 'LastName': 'de Melo', 'Affiliation': 'Korin Agricultura e Meio Ambiente Ltda., Estrada Municipal de Camaquã, sn, Caixa Postal 033, CEP: 13537-000, Ipeúna, SP, Brazil. Electronic address: jorge.xavier@korinagricultura.com.br.'}, {'ForeName': 'Hasime', 'Initials': 'H', 'LastName': 'Tokeshi', 'Affiliation': 'Rua São João, 667, Centro, CEP.: 13432-009, Piracicaba, SP, Brazil.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.07.012']
2582,32811743,"Outcomes of open ""crown"" type v. percutaneous Bunnell type repair of acute Achilles tendon ruptures. Randomized control study.",,2020,,['acute Achilles tendon ruptures'],"['open ""crown"" type v. percutaneous Bunnell type repair']",[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",[],,0.0970176,,"[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Carmont', 'Affiliation': 'The Department of Trauma & Orthopaedic Surgery, Princess Royal Hospital, Shrewsbury & Telford Hospital NHS Trust, Shropshire, United Kingdom; The Department of Orthopaedics, Institute of Clinical Sciences at Sahlgrenska Academy, Gothenburg University, Sweden. Electronic address: mcarmont@hotmail.com.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2020.08.001']
2583,32811748,Supporting health literacy using an interactive app for symptom management during radiotherapy for prostate cancer.,"OBJECTIVE


Patients' ability to self-monitor symptoms and engage in self-care activities is dependent upon their level of health literacy. Health literacy and self-care ability was compared in men with prostate cancer undergoing radiotherapy that used an app for symptom management with a control group.
METHODS


Included were an intervention group (n = 66), who used an app for symptom reporting and support for self-care, and a control group (n = 64). Outcomes were Functional Health Literacy, Communicative and Critical Health Literacy and Appraisal of Self-Care Agency (ASA-A).
RESULTS


The intervention group had improved regarding ""ability to select information needed from a variety of information sources"" (p = .020), ""ability to determine the information credible"" (p = .041), and ""being able to plan and decide what to do to improve health"" (p = .004). No inter-group difference was found for ASA-A.
CONCLUSIONS


With the support of an app for reporting and managing symptoms, important advanced health literacy skills of selecting, determining, and judging information credible may improve.
PRACTICE IMPLICATIONS


Patients undergoing treatment for prostate cancer may benefit from an individualized approach, such as an app, for communication with health care providers and as a source of health information to make decisions about their own health.",2020,"Health literacy and self-care ability was compared in men with prostate cancer undergoing radiotherapy that used an app for symptom management with a control group.
","['Patients undergoing treatment for prostate cancer', 'men with prostate cancer undergoing', 'Included were an intervention group (n = 66), who used an app for symptom reporting and support for self-care, and a control group (n = 64', 'prostate cancer']",['radiotherapy'],"['Functional Health Literacy, Communicative and Critical Health Literacy and Appraisal of Self-Care Agency (ASA-A', 'Health literacy and self-care ability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0562734', 'cui_str': 'Ability to perform personal care activity'}]",66.0,0.0295323,"Health literacy and self-care ability was compared in men with prostate cancer undergoing radiotherapy that used an app for symptom management with a control group.
","[{'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Sundberg', 'Affiliation': 'Department for Neurobiology, Care Sciences, and Society, Division of Nursing, Karolinska Institutet, Huddinge, Sweden. Electronic address: kay.sundberg@ki.se.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Lindström', 'Affiliation': 'Department for Neurobiology, Care Sciences, and Society, Division of Nursing, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Lena-Marie', 'Initials': 'LM', 'LastName': 'Petersson', 'Affiliation': 'Department for Neurobiology, Care Sciences, and Society, Division of Nursing, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Langius-Eklöf', 'Affiliation': 'Department for Neurobiology, Care Sciences, and Society, Division of Nursing, Karolinska Institutet, Huddinge, Sweden.'}]",Patient education and counseling,['10.1016/j.pec.2020.08.003']
2584,32811749,Improved health outcomes in integrative medicine visits may reflect differences in physician and patient behaviors compared to standard medical visits.,"OBJECTIVE


To identify differences in patient-physician interactions associated with improvements in GERD symptoms in a randomized controlled trial comparing integrative medicine and primary care/standard visits.
METHODS


We analyzed video recordings of 2-minute excerpts (thin slices) from the beginning, middle, and end of 21 study visits (11 standard, 10 integrative medicine).
RESULTS


According to blind coders' analysis of the excerpts, prospective improvement in GERD symptoms was most highly correlated with patients appearing pleased (r = 0.71, p < 0.01) and friendly (r = 0.67, p < 0.01) at the end of the visit, controlling for visit type. The combination of patient and physician smiling at the end of the visit was associated with improvement in GERD symptoms (r 2  = 0.45, p = 0.004). The physician in the integrative visits was more engaged (p = 0.009), friendly (p = 0.005), relaxed (p = 0.002), smiled longer (p = 0.006), gazed longer (p = 0.02), and gestured more (p = 0.007), compared to standard visits. Patients in integrative visits also smiled longer (p = 0.004).
CONCLUSION


The expanded history-taking questions asked by integrative clinicians may enhance relationship building, modifying patients' responses and improving patient-centered behaviors from clinicians,ultimately facilitating symptom improvement.
PRACTICE IMPLICATIONS


Analysis of nonverbal behaviors may facilitate a better understanding of patient-clinician interactions in integrative medicine visits and yield insights to improve clinical interactions in conventional medicine.",2020,"The physician in the integrative visits was more engaged (p = 0.009), friendly (p = 0.005), relaxed (p = 0.002), smiled longer (p = 0.006), gazed longer (p = 0.02), and gestured more (p = 0.007), compared to standard visits.",[],['integrative medicine and primary care/standard visits'],['GERD symptoms'],[],"[{'cui': 'C2350258', 'cui_str': 'Integrative Medicine'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0384732,"The physician in the integrative visits was more engaged (p = 0.009), friendly (p = 0.005), relaxed (p = 0.002), smiled longer (p = 0.006), gazed longer (p = 0.02), and gestured more (p = 0.007), compared to standard visits.","[{'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Dossett', 'Affiliation': 'Division of General Internal Medicine, Geriatrics, and Bioethics, University of California, Davis, Sacramento, USA; Division of General Internal Medicine and Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, Boston, USA; Division of General Medicine, Beth Israel Deaconess Medical Center, Boston, USA. Electronic address: mdossett@ucdavis.edu.'}, {'ForeName': 'Judith A', 'Initials': 'JA', 'LastName': 'Hall', 'Affiliation': 'Department of Psychology, Northeastern University, Boston, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center, Boston, USA.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Division of General Medicine, Beth Israel Deaconess Medical Center, Boston, USA.'}]",Patient education and counseling,['10.1016/j.pec.2020.07.014']
2585,32811786,The RESOLVE Trial for people with chronic low back pain: statistical analysis plan.,"BACKGROUND


Statistical analysis plans describe the planned data management and analysis for clinical trials. This supports transparent reporting and interpretation of clinical trial results. This paper reports the statistical analysis plan for the RESOLVE clinical trial. The RESOLVE trial assigned participants with chronic low back pain to graded sensory-motor precision training or sham-control.
RESULTS


We report the planned data management and analysis for the primary and secondary outcomes. The primary outcome is pain intensity at 18-weeks post randomization. We will use mixed-effects models to analyze the primary and secondary outcomes by intention-to-treat. We will report adverse effects in full. We also describe analyses if there is non-adherence to the interventions, data management procedures, and our planned reporting of results.
CONCLUSION


This statistical analysis plan will minimize the potential for bias in the analysis and reporting of results from the RESOLVE trial.
TRIAL REGISTRATION


ACTRN12615000610538 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619).",2020,"The RESOLVE trial assigned participants with chronic low back pain to graded sensory-motor precision training or sham-control.
","['participants with chronic low back pain to', 'people with chronic low back pain']",['graded sensory-motor precision training or sham-control'],['pain intensity'],"[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.290653,"The RESOLVE trial assigned participants with chronic low back pain to graded sensory-motor precision training or sham-control.
","[{'ForeName': 'Matthew K', 'Initials': 'MK', 'LastName': 'Bagg', 'Affiliation': 'Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; Prince of Wales Clinical School, University of New South Wales, Prince of Wales Hospital Campus, Sydney, Australia; New College Village, University of New South Wales, Sydney, Australia. Electronic address: m.bagg@neura.edu.au.'}, {'ForeName': 'Serigne', 'Initials': 'S', 'LastName': 'Lo', 'Affiliation': 'Melanoma Institute Australia, University of Sydney, Sydney, Australia; Institute for Research and Medical Consultations (IRMC), Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.'}, {'ForeName': 'Aidan G', 'Initials': 'AG', 'LastName': 'Cashin', 'Affiliation': 'Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; Prince of Wales Clinical School, University of New South Wales, Prince of Wales Hospital Campus, Sydney, Australia.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Herbert', 'Affiliation': 'Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Neil E', 'Initials': 'NE', 'LastName': ""O'Connell"", 'Affiliation': 'Department of Clinical Sciences, College of Health and Life Sciences, Brunel University London, Kingston Lane, Uxbridge, United Kingdom.'}, {'ForeName': 'Hopin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Nuffield Orthopaedic Centre, Windmill Road, Headington, United Kingdom; School of Medicine and Public Health, University of Newcastle, University Drive, Newcastle, Australia.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Hübscher', 'Affiliation': 'Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Benedict M', 'Initials': 'BM', 'LastName': 'Wand', 'Affiliation': 'School of Physiotherapy, The University of Notre Dame Australia, Fremantle, Australia.'}, {'ForeName': 'Edel', 'Initials': 'E', 'LastName': ""O'Hagan"", 'Affiliation': 'Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; Prince of Wales Clinical School, University of New South Wales, Prince of Wales Hospital Campus, Sydney, Australia.'}, {'ForeName': 'Rodrigo R N', 'Initials': 'RRN', 'LastName': 'Rizzo', 'Affiliation': 'Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; School of Medical Sciences, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'G Lorimer', 'Initials': 'GL', 'LastName': 'Moseley', 'Affiliation': 'Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; IIMPACT in Health, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Tasha R', 'Initials': 'TR', 'LastName': 'Stanton', 'Affiliation': 'Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; IIMPACT in Health, University of South Australia, Adelaide, Australia.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Goodall', 'Affiliation': 'Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'Sopany', 'Initials': 'S', 'LastName': 'Saing', 'Affiliation': 'Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'McAuley', 'Affiliation': 'Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia; School of Medical Sciences, University of New South Wales, Sydney, Australia.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2020.06.002']
2586,32811843,Innovative prolonged-release oral alkalising formulation allowing sustained urine pH increase with twice daily administration: randomised trial in healthy adults.,"A multi-particulate fixed-dose combination product, consisting of a combination of two alkalising salts formulated as prolonged-release granules, ADV7103, was developed to obtain a sustained and prolonged alkalising effect. The specific release of both types of granules was shown in vitro through their dissolution profiles, which indicated that potassium citrate was released within the first 2-3 h and potassium bicarbonate up to 10-12 h after administration. The long-lasting coverage of ADV7103 was confirmed through a randomised, placebo-controlled, double-blind, two-period study, measuring its effect on urine pH in healthy adults (n = 16) at doses of alkalising agent ranging between 0.98 and 2.88 meq/kg/day. A significant increase of urine pH with a positive dose-response in healthy adult subjects was shown. Urine pH above 7 was maintained during 24 h with a dosing equivalent to 1.44 meq/kg twice a day, while urine pH was below 6 most of the time with placebo. The effect observed was non-saturating within the range of doses evaluated and the formulation presented a good safety profile. ADV7103 provided an effective prolonged release of alkalising salts to cover a 12-h effect with adequate tolerability and could afford a twice a day (morning and evening) dosing in patients requiring long-term treatment.",2020,"The specific release of both types of granules was shown in vitro through their dissolution profiles, which indicated that potassium citrate was released within the first 2-3 h and potassium bicarbonate up to 10-12 h after administration.","['healthy adults (n\u2009=\u200916) at doses of alkalising agent ranging between 0.98\xa0and 2.88\xa0meq/kg/day', 'healthy adult subjects', 'healthy adults']","['ADV7103', 'potassium bicarbonate', 'placebo']","['urine pH', 'Urine pH']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1532570', 'cui_str': 'mEq/kg/day'}]","[{'cui': 'C0071751', 'cui_str': 'potassium bicarbonate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042044', 'cui_str': 'Urine pH test'}]",,0.373496,"The specific release of both types of granules was shown in vitro through their dissolution profiles, which indicated that potassium citrate was released within the first 2-3 h and potassium bicarbonate up to 10-12 h after administration.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Guittet', 'Affiliation': 'Advicenne, Nîmes, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roussel-Maupetit', 'Affiliation': 'Advicenne, Nîmes, France.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Manso-Silván', 'Affiliation': 'Advicenne, Nîmes, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Guillaumin', 'Affiliation': 'Advicenne, Nîmes, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vandenhende', 'Affiliation': 'ClinBay, Genappe, Belgium.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Granier', 'Affiliation': 'Advicenne, Nîmes, France. lagranier@yahoo.fr.'}]",Scientific reports,['10.1038/s41598-020-70549-2']
2587,32812021,Perception of pain in Class II malocclusion children treated with cervical headgear: a randomized controlled trial.,"OBJECTIVES


The aims of this study were: 1. to evaluate the experience of pain perceived by children during separator placement and headgear wear; 2. to find possible associations between the perceived intensity of pain and the levels of Substance P (SP) and interleukin-1 beta (IL-1β) in the gingival crevicular fluid (GCF) during these procedures; 3. to identify other factors, such as previous pain experience, which could be associated to the patients' perceived discomfort or pain during treatment.
TRIAL DESIGN


Nine-month parallel-group randomized controlled trial.
METHODS


Forty Class II malocclusion children (8-12 years) were included, half of which received a cervical headgear while the other half did not receive any treatment during the study period. Baseline pain data were recorded including previous experience to general and dental pain, Corah's Dental Anxiety Scale, and baseline pain using a visual analogue scale (VAS). Elastic separators were placed in children for 1 week, followed by molar band and cervical headgear placement. Children were seen at various time points throughout the 9-month period where at each appointment, a VAS assessment of pain as well as GCF sampling was carried out to quantify the levels of SP and IL-1β. Multiple regression analysis was performed to ascertain the influence of factors including sex, age, time, headgear wear, and baseline pain data on pain severity.
RESULTS


Pain severity and SP and IL-1β levels in the GCF follow a similar pattern, with peaks being observed 1 day after orthodontic elastic separator placement. Pain was more severe after the placement of orthodontic separators than following cervical headgear wear. With regard to pain predictors, pain is more severe in older children, those with a worse previous general pain experience, and those with higher levels of IL-1β, particularly after elastic separator placement.
CONCLUSIONS


Orthodontic pain and discomfort following orthodontic separator placement and cervical headgear wear depends on factors including age, previous pain experience, and the level of IL-1β in the GCF.",2020,"RESULTS


Pain severity and SP and IL-1β levels in the GCF follow a similar pattern, with peaks being observed 1 day after orthodontic elastic separator placement.","['Class II malocclusion children treated with cervical headgear', 'Forty Class II malocclusion children (8-12 years) were included, half of which received a cervical headgear while the other half did not receive any treatment during the study period']",[],"['Baseline pain data', ""previous experience to general and dental pain, Corah's Dental Anxiety Scale, and baseline pain using a visual analogue scale (VAS"", 'Pain severity and SP and IL-1β levels', 'Pain', 'VAS assessment of pain', 'pain and the levels of Substance P (SP) and interleukin-1 beta (IL-1β', 'Perception of pain', 'discomfort or pain']","[{'cui': 'C0399524', 'cui_str': 'Malocclusion, Angle class II, division 1'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0040460', 'cui_str': 'Toothache'}, {'cui': 'C0085380', 'cui_str': 'Dental phobia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",,0.202881,"RESULTS


Pain severity and SP and IL-1β levels in the GCF follow a similar pattern, with peaks being observed 1 day after orthodontic elastic separator placement.","[{'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Antonarakis', 'Affiliation': 'Division of Orthodontics and University Clinics of Dental Medicine, University of Geneva, Switzerland.'}, {'ForeName': 'Sofian', 'Initials': 'S', 'LastName': 'Ameur', 'Affiliation': 'Division of Orthodontics and University Clinics of Dental Medicine, University of Geneva, Switzerland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Giannopoulou', 'Affiliation': 'Division of Periodontology, University Clinics of Dental Medicine, University of Geneva, Switzerland.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Kiliaridis', 'Affiliation': 'Division of Orthodontics and University Clinics of Dental Medicine, University of Geneva, Switzerland.'}]",European journal of orthodontics,['10.1093/ejo/cjaa048']
2588,32815991,Morbidity and Mortality of Laparoscopic vs Open Total Gastrectomy for Clinical Stage I Gastric Cancer: The CLASS02 Multicenter Randomized Clinical Trial.,"Importance


The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains uncertain given the lack of high-level clinical evidence.
Objective


To compare the safety of LTG for clinical stage I gastric cancer with that of conventional open total gastrectomy (OTG).
Design, Setting, and Participants


The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group CLASS02 study was a prospective, multicenter, open-label, noninferiority, randomized clinical trial that compared the safety of LTG vs OTG with lymphadenectomy for patients with clinical stage I gastric cancer. From January 2017 to September 2018, a total of 227 patients were enrolled. Final follow-up was in October 2018.
Interventions


Eligible patients were randomized to LTG (n = 113) or OTG (n = 114) by an interactive web response system.
Main Outcomes and Measures


The primary outcome was the morbidity and mortality within 30 days following surgeries between LTG and OTG with a noninferiority margin of 10%. The secondary outcomes were recovery courses and postoperative hospital stays.
Results


A total of 214 patients were analyzed for morbidity and mortality (105 patients in the LTG group and 109 patients in the OTG group). The mean (SD) age was 59.8 (9.4) years in the LTG group and 59.4 (9.2) years in the OTG group, and most were male (LTG group, 75 of 105 [71.4%]; OTG group, 80 of 109 [73.4%]). The overall morbidity and mortality rates were not significantly different between the groups (rate difference, -1.1%; 95% CI, -11.8% to 9.6%). Intraoperative complications occurred in 3 patients (2.9%) in the LTG group and 4 patients (3.7%) in the OTG group (rate difference, -0.8%; 95% CI, -6.5% to 4.9%). In addition, there was no significant difference in the overall postoperative complication rate of 18.1% in the LTG group and 17.4% in the OTG group (rate difference, 0.7%; 95% CI, -9.6% to 11.0%). One patient in the LTG group died from intra-abdominal bleeding secondary to splenic artery hemorrhage. However, there was no significant difference in mortality between the LTG group and the OTG group (rate difference, 1.0%; 95% CI, -2.5% to 5.2%), and the distribution of complication severity was similar between the 2 groups.
Conclusions and Relevance


The results of the CLASS02 trial showed that the safety of LTG with lymphadenectomy by experienced surgeons for clinical stage I gastric cancer was comparable to that of OTG.
Trial Registration


ClinicalTrials.gov Identifier: NCT03007550.",2020,"The overall morbidity and mortality rates were not significantly different between the groups (rate difference, -1.1%; 95% CI, -11.8% to 9.6%).","['214 patients', '105 patients in the LTG group and 109 patients in the OTG group', 'From January 2017 to September 2018, a total of 227 patients were enrolled', 'I Gastric Cancer', 'patients with clinical stage I gastric cancer']","['CLASS02', 'laparoscopic total gastrectomy (LTG', 'LTG', 'Laparoscopic vs Open Total Gastrectomy', 'LTG vs OTG with lymphadenectomy', 'conventional open total gastrectomy (OTG', 'OTG']","['overall morbidity and mortality rates', 'recovery courses and postoperative hospital stays', 'Intraoperative complications', 'mortality', 'distribution of complication severity', 'overall postoperative complication rate', 'morbidity and mortality', 'Morbidity and Mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C4038617', 'cui_str': 'Laparoscopic total gastrectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205564', 'cui_str': 'Clinical stage I'}]","[{'cui': 'C4038617', 'cui_str': 'Laparoscopic total gastrectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0161899', 'cui_str': 'Total gastrectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",227.0,0.250567,"The overall morbidity and mortality rates were not significantly different between the groups (rate difference, -1.1%; 95% CI, -11.8% to 9.6%).","[{'ForeName': 'Fenglin', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'Union Hospital, Department of General Surgery, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Zekuan', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital with Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Beijing Cancer Hospital, Department of General Surgery, Peking University, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Renji Hospital, Department of General Surgery, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': 'Department of General Surgery, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Shanghai Cancer Center, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiankun', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'West China Hospital, Department of General Surgery, Sichuan University, Chengdu, China.'}, {'ForeName': 'Guoxin', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Nanfang Hospital, Department of General Surgery, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Peiwu', 'Initials': 'P', 'LastName': 'Yu', 'Affiliation': 'Department of General Surgery, The First Hospital Affiliated to AMU, Chongqing, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Guangdong General Hospital, Guangzhou, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Suo', 'Affiliation': 'Department of General Surgery, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Naiqing', 'Initials': 'N', 'LastName': 'Zhao', 'Affiliation': 'Department of Biostatistics, Fudan University School of Public Health, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Fudan University School of Public Health, Shanghai, China.'}, {'ForeName': 'Haojie', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Hongyong', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': 'Yihong', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Zhongshan Hospital, Department of General Surgery, Fudan University, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA oncology,['10.1001/jamaoncol.2020.3152']
2589,32812025,"Evaluation of the efficacy of sofosbuvir plus daclatasvir in combination with ribavirin for hospitalized COVID-19 patients with moderate disease compared with standard care: a single-centre, randomized controlled trial.","BACKGROUND


New therapeutic options are urgently needed to tackle the novel coronavirus disease 2019 (COVID-19). Repurposing existing pharmaceuticals provides an immediate treatment opportunity. We assessed the efficacy of sofosbuvir and daclatasvir with ribavirin for treating patients with COVID-19.
METHODS


This was a single-centre, randomized controlled trial in adults with moderate COVID-19 admitted to the Ghaem Shahr Razi Hospital in Mazandaran Province, Iran. Patients were randomly assigned to 400 mg sofosbuvir, 60 mg daclatasvir and 1200 mg ribavirin (intervention group) or to standard care (control group). The primary endpoint of this study was length of hospital stay. This study is registered by IRCT.ir under the ID: IRCT20200328046886N1.
RESULTS


Between 20 March 2020 and 8 April 2020, 48 patients were recruited; 24 patients were randomly assigned to the intervention group and 24 to the control group. The median duration of hospital stay was 6 days in both groups (P = 0.398). The number of ICU admissions in the sofosbuvir/daclatasvir/ribavirin group was not significantly lower than the control group (0 versus 4, P = 0.109). There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234). The cumulative incidence of recovery was higher in the sofosbuvir/daclatasvir/ribavirin arm (Gray's P = 0.033).
CONCLUSIONS


This randomized trial was too small to make definitive conclusions. There were trends in favour of the sofosbuvir/daclatasvir/ribavirin arm for recovery and lower death rates. However, there was an imbalance in the baseline characteristics between the arms. Larger randomized trials should be conducted to investigate this treatment further.",2020,"There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234).","['adults with moderate COVID-19 admitted to the Ghaem Shahr Razi Hospital in Mazandaran Province, Iran', 'hospitalized COVID-19 patients with moderate disease compared with standard care', 'treating patients with COVID-19', 'Between 20 March 2020 and 8 April 2020, 48 patients were recruited; 24 patients']","['sofosbuvir plus daclatasvir', 'daclatasvir and 1200\u2009mg ribavirin (intervention group) or to standard care (control group', 'ribavirin']","['median duration of hospital stay', 'recovery and lower death rates', 'number of ICU admissions', 'length of hospital stay', 'number of deaths', 'cumulative incidence of recovery']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",48.0,0.112652,"There was no difference in the number of deaths between the groups (0 versus 3, P = 0.234).","[{'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Abbaspour Kasgari', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Moradi', 'Affiliation': 'Education Development Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Amir Mohammad', 'Initials': 'AM', 'LastName': 'Shabani', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Farhang', 'Initials': 'F', 'LastName': 'Babamahmoodi', 'Affiliation': 'Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Davoudi Badabi', 'Affiliation': 'Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Lotfollah', 'Initials': 'L', 'LastName': 'Davoudi', 'Affiliation': 'Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Alikhani', 'Affiliation': 'Antimicrobial Resistance Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Hedayatizadeh Omran', 'Affiliation': 'Gastrointestinal Cancer Research Center, Cancer Research Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Saeedi', 'Affiliation': 'Pharmaceutical Sciences Research Center, Hemoglobinopathy Research Institute, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wentzel', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Garratt', 'Affiliation': 'Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Levi', 'Affiliation': 'Accident and Emergency Department, Homerton University Hospital NHS Trust, London, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'Department of Infectious Disease, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Translational Medicine, University of Liverpool, UK.'}, {'ForeName': 'Hafez', 'Initials': 'H', 'LastName': 'Tirgar Fakheri', 'Affiliation': 'Gut and Liver Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa332']
2590,32812039,Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection (COVID-19): a randomized controlled trial.,"BACKGROUND


Currently no effective antiviral therapy has been found to treat COVID-19. The aim of this trial was to assess if the addition of sofosbuvir and daclatasvir improved clinical outcomes in patients with moderate or severe COVID-19.
METHODS


This was an open-label, multicentre, randomized controlled clinical trial in adults with moderate or severe COVID-19 admitted to four university hospitals in Iran. Patients were randomized into a treatment arm receiving sofosbuvir and daclatasvir plus standard care, or a control arm receiving standard care alone. The primary endpoint was clinical recovery within 14 days of treatment. The study is registered with IRCT.ir under registration number IRCT20200128046294N2.
RESULTS


Between 26 March and 26 April 2020, 66 patients were recruited and allocated to either the treatment arm (n = 33) or the control arm (n = 33). Clinical recovery within 14 days was achieved by 29/33 (88%) in the treatment arm and 22/33 (67%) in the control arm (P = 0.076). The treatment arm had a significantly shorter median duration of hospitalization [6 days (IQR 4-8)] than the control group [8 days (IQR 5-13)]; P = 0.029. Cumulative incidence of hospital discharge was significantly higher in the treatment arm versus the control (Gray's P = 0.041). Three patients died in the treatment arm and five in the control arm. No serious adverse events were reported.
CONCLUSIONS


The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone. Although fewer deaths were observed in the treatment arm, this was not statistically significant. Conducting larger scale trials seems prudent.",2020,The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone.,"['adults with moderate or severe COVID-19 admitted to four university hospitals in Iran', 'patients admitted to hospital with moderate or severe coronavirus infection (COVID-19', '66 patients', 'Between 26 March and 26 April 2020', 'patients with moderate or severe COVID-19']","['sofosbuvir and daclatasvir plus standard care, or a control arm receiving standard care alone', 'Sofosbuvir and daclatasvir']","['median duration of hospitalization', 'duration of hospital stay', 'Clinical recovery', 'serious adverse events', 'deaths', 'clinical recovery', 'Cumulative incidence of hospital discharge']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0206750', 'cui_str': 'Coronavirus infection'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}]",66.0,0.111872,The addition of sofosbuvir and daclatasvir to standard care significantly reduced the duration of hospital stay compared with standard care alone.,"[{'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Sadeghi', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ali Asgari', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Norouzi', 'Affiliation': 'Golestan Research Center of Gastroenterology and Hepatology, Golestan University of Medical Science, Gorgan, Iran.'}, {'ForeName': 'Zahedin', 'Initials': 'Z', 'LastName': 'Kheiri', 'Affiliation': 'Department of Internal Medicine, Baharloo hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Anushirvani', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Montazeri', 'Affiliation': 'Department of infectious diseases, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hadiseh', 'Initials': 'H', 'LastName': 'Hosamirudsai', 'Affiliation': 'Department of Infectious Diseases, Baharloo Hospital, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Afhami', 'Affiliation': 'Department of infectious diseases, Shariati Hospital, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Akbarpour', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Rasoul', 'Initials': 'R', 'LastName': 'Aliannejad', 'Affiliation': 'Department of Pulmonary and Critical Care, Shariati Hospital, Thoracic Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Reza', 'Initials': 'AR', 'LastName': 'Radmard', 'Affiliation': 'Department of Radiology, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir H', 'Initials': 'AH', 'LastName': 'Davarpanah', 'Affiliation': 'Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Levi', 'Affiliation': 'Department of Emergency Medicine, Homerton University Hospital, London, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Wentzel', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Ambar', 'Initials': 'A', 'LastName': 'Qavi', 'Affiliation': 'School of Public Health, Imperial College London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Garratt', 'Affiliation': 'Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Simmons', 'Affiliation': 'Department of Infectious Disease, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Merat', 'Affiliation': 'Liver and Pancreatobiliary Diseases Research Center, Digestive Disease Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}]",The Journal of antimicrobial chemotherapy,['10.1093/jac/dkaa334']
2591,32812041,Impact of gemtuzumab ozogamicin on MRD and relapse risk in NPM1 mutated AML patients: results from the AMLSG 09-09 Trial.,"Monitoring of measurable residual disease (MRD) provides prognostic information in patients with Nucleophosmin1 mutated (NPM1mut) acute myeloid leukemia (AML) and represents a powerful tool to evaluate treatment effects within clinical trials. We determined NPM1mut transcript levels (TL) by RQ-PCR and evaluated the prognostic impact of NPM1mut MRD and the effect of gemtuzumab ozogamicin (GO) on NPM1mut TL and the cumulative incidence of relapse (CIR) in patients with NPM1mut AML enrolled in the randomized phase III AMLSG 09-09 trial. 3733 bone marrow (BM) and 3793 peripheral blood (PB) samples from 469 patients were analyzed. NPM1mut TL log10 reduction ≥3 and achievement of MRD negativity in BM and PB were significantly associated with a lower CIR rate, after two treatment cycles and at end of treatment (EOT). In multivariate analyses, MRD positivity consistently revealed as poor prognostic factor in BM and PB. With regard to treatment effect, the median NPM1mut TL were significantly lower in the GO-Arm across all treatment cycles, resulting in a significantly higher proportion of patients achieving MRD negativity at EOT (56% vs 41%; P=.01). The betterreduction of NPM1mut TL after two treatment cycles in MRD-positive patients by the addition of GO led to a significantly lower CIR rate (4-year CIR 29.3% vs 45.7%, P=.009). In conclusion, the addition of GO to intensive chemotherapy in NPM1mut AML resulted in a significantly better reduction of NPM1mut TL across all treatment cycles leading to a significantly lower relapse rate. The AMLSG 09-09 trial was registered at www.clinicaltrials.gov as #NCT00893399.",2020,"With regard to treatment effect, the median NPM1mut TL were significantly lower in the GO-Arm across all treatment cycles, resulting in a significantly higher proportion of patients achieving MRD negativity at EOT (56% vs 41%; P=.01).","['patients with NPM1mut AML enrolled in the randomized phase III AMLSG 09-09 trial', '469 patients were analyzed', '3733 bone marrow (BM) and 3793 peripheral blood', 'patients with Nucleophosmin1 mutated (NPM1mut) acute myeloid leukemia (AML', 'NPM1 mutated AML patients']","['gemtuzumab ozogamicin (GO', 'gemtuzumab ozogamicin']","['median NPM1mut TL', 'NPM1mut TL log10 reduction ≥3 and achievement of MRD negativity in BM and PB', 'lower CIR rate', 'MRD and relapse risk', 'CIR rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0069141', 'cui_str': 'nucleophosmin'}]","[{'cui': 'C0876099', 'cui_str': 'Mylotarg'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1690986', 'cui_str': 'log10'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0543478', 'cui_str': 'Residual Tumour'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",3733.0,0.0502942,"With regard to treatment effect, the median NPM1mut TL were significantly lower in the GO-Arm across all treatment cycles, resulting in a significantly higher proportion of patients achieving MRD negativity at EOT (56% vs 41%; P=.01).","[{'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Kapp-Schwoerer', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Weber', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Corbacioglu', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Verena I', 'Initials': 'VI', 'LastName': 'Gaidzik', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Paschka', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Krönke', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Frauke', 'Initials': 'F', 'LastName': 'Theis', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Frank G', 'Initials': 'FG', 'LastName': 'Rücker', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Maria-Veronica', 'Initials': 'MV', 'LastName': 'Teleanu', 'Affiliation': 'National Center for Tumor Diseases Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Panina', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Jahn', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Julia K', 'Initials': 'JK', 'LastName': 'Herzig', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Kubanek', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Schrade', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Gohring', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Fiedler', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kindler', 'Affiliation': 'University Medical Center of Mainz, Mainz, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schroeder', 'Affiliation': 'University of Duesseldorf, Duesseldorf, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'University of Bonn, Bonn, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lübbert', 'Affiliation': 'University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Wattad', 'Affiliation': 'Klinikum Hochsauerland, Meschede, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Götze', 'Affiliation': 'Technical University of Munich School of Medicine, Munich, Germany.'}, {'ForeName': 'Heinz A', 'Initials': 'HA', 'LastName': 'Horst', 'Affiliation': 'University Hospital of Schleswig-Hostein, Kiel, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Koller', 'Affiliation': 'Hanuschhospital, Vienna, Austria.'}, {'ForeName': 'Gerald G', 'Initials': 'GG', 'LastName': 'Wulf', 'Affiliation': 'Georg-August University, Goettingen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Schleicher', 'Affiliation': 'Katharinenhospital Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bentz', 'Affiliation': 'Städtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Krauter', 'Affiliation': 'Klinikum Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Bullinger', 'Affiliation': 'Charité University Medicine, Berlin, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Krzykalla', 'Affiliation': 'German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Benner', 'Affiliation': 'German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital, Germany.'}, {'ForeName': 'Felicitas', 'Initials': 'F', 'LastName': 'Thol', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'University Hospital Ulm, Ulm, Germany.'}, {'ForeName': 'Konstanze', 'Initials': 'K', 'LastName': 'Döhner', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}]",Blood,['10.1182/blood.2020005998']
2592,32812046,A qualitative account of young people's experiences of alcohol screening and brief interventions in schools: SIPS Jr-HIGH trial findings.,"BACKGROUND


The United Kingdom (UK) has seen a decrease in the number of young people drinking alcohol. However, the UK prevalence of underage drinking still ranks amongst the highest in Western Europe. Whilst there is a wealth of evidence reporting on the effectiveness of both primary, and secondary interventions, there are few reports of the experiences of young people who receive them.
METHODS


The present study reports findings from interviews with 33 young people who were involved in an alcohol screening and brief intervention randomized controlled trial in schools in England. All interviews were analysed using inductive applied thematic analysis.
RESULTS


Three major themes were identified following the analysis process: 1) drinking identities and awareness of risk; 2) access to support and advice in relation to alcohol use; and 3) appraisal of the intervention and potential impact on alcohol use.
CONCLUSIONS


There appeared to be a reluctance from participants to describe themselves as someone who drinks alcohol. Furthermore, those who did drink alcohol often did so with parental permission. There was variation amongst participants as to how comfortable they felt talking about alcohol issues with school staff. Overall participants felt the intervention was useful, but would be better suited to 'heavier' drinkers.",2020,There was variation amongst participants as to how comfortable they felt talking about alcohol issues with school staff.,"['33 young people who were involved in an alcohol screening and brief intervention randomized controlled trial in schools in England', ""young people's experiences of alcohol screening and brief interventions in schools""]",[],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",[],[],33.0,0.0264986,There was variation amongst participants as to how comfortable they felt talking about alcohol issues with school staff.,"[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Giles', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'McGeechan', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Scott', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'McGovern', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, NE2 4AX, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boniface', 'Affiliation': ""Institute of Psychiatry, Psychology, & Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ramsay', 'Affiliation': ""Institute of Psychiatry, Psychology, & Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hendrie', 'Affiliation': 'Centre for Health Services Research, University of Kent, Canterbury, Kent, CT2 7NF, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, NE2 4AX, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sumnall', 'Affiliation': 'Faculty of Education, Health and Community, Liverpool John Moores University, Liverpool, L3 2 ET, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Newbury-Birch', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kaner', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, NE2 4AX, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdz074']
2593,32812316,Application of WeChat-assisted peri-operative care in children with congenital megacolon.,"AIM


This study explored the clinical effects of WeChat-based peri-operative care on parents of children with congenital megacolon.
METHODS


Participants were randomly divided into WeChat group and telephone group. This study explored parents' knowledge of the care of children with megacolon, the follow-up rate of children, post-operative defaecation function and complications.
RESULTS


WeChat group scored better in nursing knowledge than telephone group, and the difference was statistically significant. The lost follow-up rate in WeChat group was lower than that in telephone group, and the difference was statistically significant. Post-operative defaecation was also better in the WeChat group than in the phone group. Most complications in the phone group were significantly higher than those in the WeChat group.
CONCLUSION


Peri-operative care for parents of children with megacolon through WeChat can effectively enhance the level of parental care knowledge, improve defaecation, reduce the occurrence of certain complications and reduce lost follow-up.",2020,"WeChat can effectively enhance the level of parental care knowledge, improve defaecation, reduce the occurrence of certain complications and reduce lost follow-up.","['parents of children with megacolon through', 'Participants', 'parents of children with congenital megacolon', 'children with congenital megacolon']","['WeChat-assisted peri-operative care', 'WeChat-based peri-operative care', 'Peri-operative care', 'WeChat group and telephone']",['nursing knowledge'],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025160', 'cui_str': 'Megacolon'}, {'cui': 'C0019569', 'cui_str': ""Hirschsprung's disease""}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0203934,"WeChat can effectively enhance the level of parental care knowledge, improve defaecation, reduce the occurrence of certain complications and reduce lost follow-up.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Fujian Province Maternal and Child Health Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'YiFan', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Fujian Province Maternal and Child Health Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'DianMing', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'Fujian Province Maternal and Child Health Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'JianXi', 'Initials': 'J', 'LastName': 'Bai', 'Affiliation': 'Fujian Province Maternal and Child Health Hospital, Fuzhou, Fujian, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Fujian Province Maternal and Child Health Hospital, Fuzhou, Fujian, China.'}]",Journal of paediatrics and child health,['10.1111/jpc.14990']
2594,32812324,Clinical outcomes of laparoscopic-based renal denervation plus adrenalectomy vs adrenalectomy alone for treating resistant hypertension caused by unilateral aldosterone-producing adenoma.,"Previous studies describing renal denervation (RDN) from the intima of the renal artery for the treatment of resistant hypertension have reported variable efficacies, and RDN triggers renal intimal injury and atherosclerosis. This study aimed to evaluate the efficacy and safety of RDN from the adventitia of renal artery plus unilateral laparoscopic adrenalectomy to treat patients with resistant hypertension caused by unilateral aldosterone-producing adenoma (APA). A total of 60 consecutive patients with resistant hypertension caused by unilateral APA were enrolled in this study. Patients were randomly assigned to undergo RDN from the adventitia of the renal artery plus adrenalectomy (RDN group, n = 30) or adrenalectomy alone (control group, n = 30) and were followed up for 12 months. The primary efficacy end point was the change in 24-hours mean ambulatory systolic blood pressure (SBP) from baseline to 12 months. At the 12-month follow-up, the mean reduction of 24-hours average SBP and office SBP in the RDN group was 20.7 ± 15.2 and 37.1 ± 26.0 mm Hg, respectively, which was significantly higher than the mean reduction of 24-hours average SBP (11.9 ± 11.1 mm Hg, P = .017) and the office SBP (25.9 ± 16.8 mm Hg, P = .035) in the control group. Serum potassium levels returned to normal 12 months post-procedure. Patients in the RDN group had higher proportion of cured clinical and biochemical outcomes than those in the control group (35.7% vs 17.9% in clinical outcome; 96.4% vs 89.3% in biochemical outcome, respectively). There were no procedural-, device-, or treatment-related safety events during the 12-month follow-up period between the groups. In conclusion, RDN from the adventitia of the renal artery plus unilateral laparoscopic adrenalectomy is more effective than adrenalectomy alone for treating resistant hypertension caused by unilateral APA.",2020,"There were no procedural-, device-, or treatment-related safety events during the 12-month follow-up period between the groups.","['60 consecutive patients with resistant hypertension caused by unilateral APA', 'patients with resistant hypertension caused by unilateral aldosterone-producing adenoma (APA']","['laparoscopic-based renal denervation plus adrenalectomy vs adrenalectomy alone', 'renal artery plus unilateral laparoscopic adrenalectomy', 'RDN', 'renal artery plus adrenalectomy (RDN group, n\xa0=\xa030) or adrenalectomy alone (control group, n\xa0=\xa030']","['24-hours average SBP', '24-hours mean ambulatory systolic blood pressure (SBP', 'efficacy and safety', 'mean reduction of 24-hours average SBP and office SBP', 'higher proportion of cured clinical and biochemical outcomes', 'safety events', 'Serum potassium levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0009777', 'cui_str': 'Aldosterone-producing adenoma'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0011307', 'cui_str': 'Denervation - action'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001632', 'cui_str': 'Adrenalectomy'}, {'cui': 'C0035065', 'cui_str': 'Structure of renal artery'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0521267', 'cui_str': 'Laparoscopic adrenalectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C1282151', 'cui_str': 'Average systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}]",60.0,0.026022,"There were no procedural-, device-, or treatment-related safety events during the 12-month follow-up period between the groups.","[{'ForeName': 'Yahui', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Cardiology, Henan University People's Hospital, Henan Provincial People's Hospital, Zhengzhou, China.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Zhu', 'Affiliation': 'Henan Provincial Key Lab for Control of Coronary Heart Disease, Central China Fuwai Hospital, Zhengzhou, China.'}, {'ForeName': 'Lijie', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Henan Provincial Key Lab for Control of Coronary Heart Disease, Central China Fuwai Hospital, Zhengzhou, China.'}, {'ForeName': 'Linwei', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Henan Provincial Key Lab for Control of Coronary Heart Disease, Central China Fuwai Hospital, Zhengzhou, China.'}, {'ForeName': 'Degang', 'Initials': 'D', 'LastName': 'Ding', 'Affiliation': ""Department of Urinary Surgery, Zhengzhou University People's Hospital, Henan Provincial People's Hospital, Zhengzhou, China.""}, {'ForeName': 'Zhonghua', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""Department of Urinary Surgery, Zhengzhou University People's Hospital, Henan Provincial People's Hospital, Zhengzhou, China.""}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': ""Department of Urinary Surgery, Zhengzhou University People's Hospital, Henan Provincial People's Hospital, Zhengzhou, China.""}, {'ForeName': 'Qiuping', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Henan Provincial Key Lab for Control of Coronary Heart Disease, Central China Fuwai Hospital, Zhengzhou, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Henan Provincial Key Lab for Control of Coronary Heart Disease, Central China Fuwai Hospital, Zhengzhou, China.'}, {'ForeName': 'Jiguang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Hypertension, Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital, The Shanghai Institute of Hypertension, Shanghai, China.'}, {'ForeName': 'Chuanyu', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Department of Cardiology, Henan University People's Hospital, Henan Provincial People's Hospital, Zhengzhou, China.""}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13963']
2595,32812363,Transcutaneous spinal direct current stimulation increases corticospinal transmission and enhances voluntary motor output in humans.,"Optimization of motor performance is of importance in daily life, in relation to recovery following injury as well as for elite sports performance. The present study investigated whether transcutaneous spinal direct current stimulation (tsDCS) may enhance voluntary ballistic activation of ankle muscles and descending activation of spinal motor neurons in able-bodied adults. Forty-one adults (21 men; 24.0 ± 3.2 years) participated in the study. The effect of tsDCS on ballistic motor performance and plantar flexor muscle activation was assessed in a double-blinded sham-controlled cross-over experiment. In separate experiments, the underlying changes in excitability of corticospinal and spinal pathways were probed by evaluating soleus (SOL) motor evoked potentials (MEPs) following single-pulse transcranial magnetic stimulation (TMS) over the primary motor cortex, SOL H-reflexes elicited by tibial nerve stimulation and TMS-conditioning of SOL H-reflexes. Measures were obtained before and after cathodal tsDCS over the thoracic spine (T11-T12) for 10 min at 2.5 mA. We found that cathodal tsDCS transiently facilitated peak acceleration in the ballistic motor task compared to sham tsDCS. Following tsDCS, SOL MEPs were increased without changes in H-reflex amplitudes. The short-latency facilitation of the H-reflex by subthreshold TMS, which is assumed to be mediated by the fast conducting monosynaptic corticomotoneuronal pathway, was also enhanced by tsDCS. We argue that tsDCS briefly facilitates voluntary motor output by increasing descending drive from corticospinal neurones to spinal plantar flexor motor neurons. tsDCS can thus transiently promote within-session CNS function and voluntary motor output and holds potential as a technique in the rehabilitation of motor function following central nervous lesions.",2020,"Following tsDCS, SOL MEPs were increased without changes in H-reflex amplitudes.","['Forty-one adults (21 men; 24.0\xa0±\xa03.2\xa0years) participated in the study', 'able-bodied adults', 'humans']","['transcutaneous spinal direct current stimulation (tsDCS', 'tsDCS', 'single-pulse transcranial magnetic stimulation (TMS', 'Transcutaneous spinal direct current stimulation']","['H-reflex amplitudes', 'ballistic motor performance and plantar flexor muscle activation', 'soleus (SOL) motor evoked potentials (MEPs']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0442831', 'cui_str': 'Direct current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C1564622', 'cui_str': 'Transcranial Magnetic Stimulation, Single Pulse'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]","[{'cui': 'C0018447', 'cui_str': 'H-reflex'}, {'cui': 'C0443149', 'cui_str': 'Ballistic'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0242694', 'cui_str': 'Soleus muscle structure'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}]",41.0,0.088158,"Following tsDCS, SOL MEPs were increased without changes in H-reflex amplitudes.","[{'ForeName': 'Tomofumi', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Mikkel M', 'Initials': 'MM', 'LastName': 'Beck', 'Affiliation': 'Department of Nutrition, Exercise and Sports (NEXS), University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Eva R', 'Initials': 'ER', 'LastName': 'Therkildsen', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Svane', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Forman', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Lorentzen', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Bernard A', 'Initials': 'BA', 'LastName': 'Conway', 'Affiliation': 'Department of Biomedical Engineering, University of Strathclyde, Glasgow, UK.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Lundbye-Jensen', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Svend S', 'Initials': 'SS', 'LastName': 'Geertsen', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}, {'ForeName': 'Jens B', 'Initials': 'JB', 'LastName': 'Nielsen', 'Affiliation': 'Department of Neuroscience, University of Copenhagen, Copenhagen N, Denmark.'}]",Physiological reports,['10.14814/phy2.14531']
2596,32812384,Muscular endurance and muscle metabolic responses to 8 weeks of omega-3 polyunsaturated fatty acids supplementation.,"BACKGROUND


It has been well known that exercise training improves muscular endurance; however, whether nutritional strategies can be used to enhance muscular endurance remains unclear. Herein, we tested the hypothesis that 8 weeks of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation, known to promote oxygen availability and lipid metabolism, would attenuate muscular fatigue caused by numerous muscle contractions.
METHODS


Nineteen healthy men were randomly assigned to a placebo group (n = 9) and fish oil group (n = 10) in a double-blind fashion. The fish oil group consumed EPA-rich fish oil that contains 600-mg EPA and 260-mg DHA per day for 8 weeks. The placebo group received matching capsules for the same duration of time. After the 8-week intervention, subjects performed muscular endurance test that was repeated knee extensions with weights equal to 40% of the subject's body weight.
RESULTS


Maximal repetitions to exhaustion were recorded. In addition, maximum isometric voluntary muscle contraction (MVC), muscle metabolism using near-infrared spectroscopy, and blood lactate were measured during the test. Subjects in both groups reached exhaustion after the muscular endurance test, while the maximal repetitions did not differ between the groups. Similarly, there is no significant difference in oxygen saturation in muscle tissue (StO2), an index of muscle oxygen availability, between the groups. Also, MVC and blood lactate did not change between groups.
CONCLUSION


In conclusion, the present study provided evidence that muscle fatigue caused by knee extensions cannot be attenuated by EPA and DHA supplementation in healthy subjects.",2020,"Subjects in both groups reached exhaustion after the muscular endurance test, while the maximal repetitions did not differ between the groups.","['Nineteen healthy men', 'healthy subjects']","['exercise training', 'omega-3 polyunsaturated fatty acids supplementation', 'placebo group (n\xa0=\xa09) and fish oil group', 'eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) supplementation', 'placebo']","['maximum isometric voluntary muscle contraction (MVC), muscle metabolism using near-infrared spectroscopy, and blood lactate', 'MVC and blood lactate', 'muscular endurance', 'Muscular endurance and muscle metabolic responses', 'oxygen saturation in muscle tissue (StO2), an index of muscle oxygen availability']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}]",19.0,0.209075,"Subjects in both groups reached exhaustion after the muscular endurance test, while the maximal repetitions did not differ between the groups.","[{'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Morishima', 'Affiliation': 'Sports Research Center, Hosei University, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Tsuchiya', 'Affiliation': 'Laboratory of Health and Sports Sciences, Meiji Gakuin University, Kanagawa, Japan.'}, {'ForeName': 'Hisashi', 'Initials': 'H', 'LastName': 'Ueda', 'Affiliation': 'Faculty of Health and Medical Science, Teikyo Heisei University, Chiba, Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Ochi', 'Affiliation': 'Sports Research Center, Hosei University, Tokyo, Japan.'}]",Physiological reports,['10.14814/phy2.14546']
2597,32812488,Rapid On-Site Evaluation During Radial Endobronchial Ultrasound-Guided Transbronchial Lung Biopsy for the Diagnosis of Peripheral Pulmonary Lesions.,"OBJECTIVE


To evaluate the diagnostic value of radial endobronchial ultrasound (R-EBUS) combination with rapid on-site evaluation (ROSE) guided transbronchial lung biopsy (TBLB) for peripheral pulmonary lesions.
METHODS


Peripheral pulmonary lesions identified by computed tomography underwent R-EBUS with or without ROSE randomly from February 2016 to August 2017. The diagnostic yield and the operation time were compared.
RESULTS


In total, 158 patients were involved in and completed this research, including 84 cases in the group of R-EBUS with ROSE, and 74 in the group without ROSE. The diagnostic yield of ROSE group was 85.7%. Among these positive cases, 69.4% cases were malignant tumors, and 30.6% cases were benign lesions. The operation time was (24.6 ± 6.3) min. In the group without ROSE, the diagnostic yield was 70.3%, including 35 malignant tumors (67.3%), and 17 benign lesions (32.7%). The operation time was (31.5 ± 6.8) min. There were significant differences between both groups in the diagnostic yield (χ2 = 5.556, P = 0.018) and in the operation time (t = 3.187, P < 0.01). No serious procedure related complications were observed, such as pneumothorax and hemorrhage.
CONCLUSION


ROSE can improve the diagnostic yield, and shorten the operation time. R-EBUS combined with ROSE is a safe and effective technique for peripheral pulmonary lesions.",2020,"There were significant differences between both groups in the diagnostic yield (χ2 = 5.556, P = 0.018) and in the operation time (t = 3.187, P < 0.01).","['Peripheral pulmonary lesions identified by computed tomography underwent R-EBUS with or without ROSE randomly from February 2016 to August 2017', '158 patients were involved in and completed this research, including 84 cases in the group of R-EBUS with ROSE, and 74 in the group without ROSE']","['ROSE', 'radial endobronchial ultrasound (R-EBUS) combination with rapid on-site evaluation (ROSE) guided transbronchial lung biopsy (TBLB', 'Radial Endobronchial Ultrasound-Guided Transbronchial Lung Biopsy']","['pneumothorax and hemorrhage', 'diagnostic yield and the operation time', 'operation time', 'diagnostic yield']","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C3160856', 'cui_str': 'Endobronchial ultrasound'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0863477', 'cui_str': 'Transbronchial lung biopsy'}]","[{'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",158.0,0.0182446,"There were significant differences between both groups in the diagnostic yield (χ2 = 5.556, P = 0.018) and in the operation time (t = 3.187, P < 0.01).","[{'ForeName': 'Chunhua', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Respiratory Medicine, 56647The Affiliated Brain Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Respiratory Medicine, 56647The Affiliated Brain Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yuan', 'Affiliation': 'Department of Respiratory Medicine, 56647The Affiliated Brain Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Huidi', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'Department of Pathology, 56647The Affiliated Brain Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory Medicine, 56647The Affiliated Brain Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Rusong', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Department of Thoracic Surgery, 56647The Affiliated Brain Hospital of Nanjing Medical University, Nanjing, Jiangsu, China.'}]",Technology in cancer research & treatment,['10.1177/1533033820947482']
2598,32812644,A qualitative account of young people's experiences of alcohol screening and brief interventions in schools: SIPS Jr-HIGH trial findings.,"BACKGROUND


The United Kingdom (UK) has seen a decrease in the number of young people drinking alcohol. However, the UK prevalence of underage drinking still ranks amongst the highest in Western Europe. Whilst there is a wealth of evidence reporting on the effectiveness of both primary, and secondary interventions, there are few reports of the experiences of young people who receive them.
METHODS


The present study reports findings from interviews with 33 young people who were involved in an alcohol screening and brief intervention randomized controlled trial in schools in England. All interviews were analysed using inductive applied thematic analysis.
RESULTS


Three major themes were identified following the analysis process: 1) drinking identities and awareness of risk; 2) access to support and advice in relation to alcohol use; and 3) appraisal of the intervention and potential impact on alcohol use.
CONCLUSIONS


There appeared to be a reluctance from participants to describe themselves as someone who drinks alcohol. Furthermore, those who did drink alcohol often did so with parental permission. There was variation amongst participants as to how comfortable they felt talking about alcohol issues with school staff. Overall participants felt the intervention was useful, but would be better suited to 'heavier' drinkers.",2020,There was variation amongst participants as to how comfortable they felt talking about alcohol issues with school staff.,"['33 young people who were involved in an alcohol screening and brief intervention randomized controlled trial in schools in England', ""young people's experiences of alcohol screening and brief interventions in schools""]",[],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",[],[],33.0,0.0264986,There was variation amongst participants as to how comfortable they felt talking about alcohol issues with school staff.,"[{'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Giles', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'McGeechan', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Scott', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'McGovern', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, NE2 4AX, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Boniface', 'Affiliation': ""Institute of Psychiatry, Psychology, & Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ramsay', 'Affiliation': ""Institute of Psychiatry, Psychology, & Neuroscience, King's College London, London SE5 8AF, UK.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Hendrie', 'Affiliation': 'Centre for Health Services Research, University of Kent, Canterbury, Kent, CT2 7NF, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'McColl', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, NE2 4AX, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Sumnall', 'Affiliation': 'Faculty of Education, Health and Community, Liverpool John Moores University, Liverpool, L3 2 ET, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Newbury-Birch', 'Affiliation': 'School of Social Sciences, Humanities and Law, Teesside University, Middlesbrough, TS1 3BX, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kaner', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, NE2 4AX, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdz074']
2599,32812652,Programmed intermittent boluses vs continuous epidural infusion in labor using an adrenaline containing solution: a randomized trial.,"BACKGROUND


Traditionally, epidural analgesia has been maintained by using a continuous infusion (CEI) with the addition of patient controlled boluses (PCEA). In recent years, programmed intermittent boluses (PIEB) has emerged as an alternative showing better efficacy in randomized studies. In this study the aim was to test PIEB+PCEA vs CEI+PCEA using an epidural solution containing adrenaline.
METHODS


150 nulliparous and multiparous laboring women were randomized to maintain epidural analgesia with either PIEB+PCEA (5 ml bolus every hour, 5 ml PCEA bolus lockout 20 minutes) or CEI+PCEA (5 ml/h, 5 ml PCEA bolus, lockout 20 minutes) using a solution of bupivacaine 1mg/ml, fentanyl 2 mcg/ml and adrenaline 2 mcg/ml. The primary outcome was total hourly consumption of the epidural solution. Secondary outcomes included hourly pain scores, motor block at 60 minutes and 10 cm cervical dilation, maternal satisfaction, and the need for anesthetist intervention and time to this intervention.
RESULTS


We found no differences in hourly drug consumption between the groups (mean 9.0 ml/h (SD 3.7) (CEI group) vs. 8.1 ml/h (SD 2.0) (PIEB group), p=0.08). We found a significant difference in number of successfully administered PCEA boluses (mean no. 3.9 (SD 4.1) (CEI group) vs. 1.9 (SD 2.0) (PIEB group), p<0.001). We found no significant differences in pain score, motor block, maternal satisfaction and the need for anesthetist intervention.
CONCLUSION


In this study, we found no clinically relevant differences using PIEB+PCEA compared to CEI+PCEA when using an epidural solution containing adrenaline.",2020,"We found no significant differences in pain score, motor block, maternal satisfaction and the need for anesthetist intervention.
","['150 nulliparous and multiparous', 'laboring women']","['maintain epidural analgesia with either PIEB+PCEA', 'CEI+PCEA', 'adrenaline containing solution', 'adrenaline', 'bupivacaine 1mg/ml, fentanyl 2 mcg/ml and adrenaline 2 mcg/ml', 'PIEB+PCEA vs CEI+PCEA']","['hourly drug consumption', 'total hourly consumption of the epidural solution', 'hourly pain scores, motor block at 60 minutes and 10 cm cervical dilation, maternal satisfaction, and the need for anesthetist intervention and time to this intervention', 'pain score, motor block, maternal satisfaction and the need for anesthetist intervention']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0026751', 'cui_str': 'Multiparous'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}]","[{'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0228134', 'cui_str': 'Structure of epidural space of spine'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0079103', 'cui_str': 'Cervical dilatation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",150.0,0.3965,"We found no significant differences in pain score, motor block, maternal satisfaction and the need for anesthetist intervention.
","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Haidl', 'Affiliation': 'Department of Anesthesia, Akershus University hospital, Sykehusveien 25, 1478, Lørenskog, Norway.'}, {'ForeName': 'Leiv Arne', 'Initials': 'LA', 'LastName': 'Rosseland', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, P.O box 1171, 0318, Oslo, Norway.'}, {'ForeName': 'Anne-Marte', 'Initials': 'AM', 'LastName': 'Rørvik', 'Affiliation': 'Department of Anesthesia, Akershus University hospital, Sykehusveien 25, 1478, Lørenskog, Norway.'}, {'ForeName': 'Vegard', 'Initials': 'V', 'LastName': 'Dahl', 'Affiliation': 'Department of Anesthesia, Akershus University hospital, Sykehusveien 25, 1478, Lørenskog, Norway.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13689']
2600,32812888,A Mobile Health Intervention for Adolescents Exposed to Secondhand Smoke: Pilot Feasibility and Efficacy Study.,"BACKGROUND


Secondhand smoke (SHS) exposure in children and adolescents has adverse health effects. For adolescents of lower socioeconomic status (SES), exposure is widespread, evidenced in the measurement of urinary cotinine, a major metabolite of nicotine. Direct intervention with exposed children has been proposed as a novel method, yet there is minimal evidence of its efficacy. Combining this approach with a mobile health (mHealth) intervention may be more time and cost-effective and feasible for adolescent populations.
OBJECTIVE


In this pilot study, we assessed the feasibility and preliminary evidence of efficacy of a 30-day text message-based mHealth intervention targeted at reducing SHS exposure in adolescent populations of low SES.
METHODS


For the study, 14 nonsmoking and nonvaping participants between the ages of 12-21 years exposed to SHS were enrolled. The intervention consisted of a daily text message sent to the participants over the course of a month. Text message types included facts and information about SHS, behavioral methods for SHS avoidance, or true-or-false questions. Participants were asked to respond to each message within 24 hours as confirmation of receipt. Feasibility outcomes included completion of the 30-day intervention, receiving and responding to text messages, and feedback on the messages. Efficacy outcomes included a reduction in urinary cotinine, accuracy of true-or-false responses, and participants' perceptions of effectiveness.
RESULTS


Of the 14 participants that were enrolled, 13 completed the intervention. Though not required, all participants had their own cell phones with unlimited text messaging plans. Of the total number of text messages sent to the 13 completers, 91% (372/407) of them received on-time responses. Participant feedback was generally positive, with most requesting more informational and true-or-false questions. In terms of efficacy, 54% (6/11) of participants reduced their cotinine levels (however, change for the group overall was not statistically significant (P=.33) and 45% (5/11) of participants increased their cotinine levels. Of the total number of true-or-false questions sent across all completers, 77% (56/73) were answered correctly. Participants' ratings of message effectiveness averaged 85 on a scale of 100.
CONCLUSIONS


In this pilot study, the intervention was feasible as the majority of participants had access to a cell phone, completed the study, and engaged by responding to the messages. The efficacy of the study requires further replication, as only half of the participants reduced their cotinine levels. However, participants answered the majority of true-or-false questions accurately and reported that the messages were helpful.",2020,"Efficacy outcomes included a reduction in urinary cotinine, accuracy of true-or-false responses, and participants' perceptions of effectiveness.
","['adolescent populations of low SES', '14 participants that were enrolled', '14 nonsmoking and nonvaping participants between the ages of 12-21 years exposed to SHS were enrolled', 'Adolescents Exposed to Secondhand Smoke', 'children and adolescents']","['Mobile Health Intervention', 'mobile health (mHealth) intervention', '30-day text message-based mHealth intervention']","['cotinine levels', 'completion of the 30-day intervention, receiving and responding to text messages, and feedback on the messages', ""urinary cotinine, accuracy of true-or-false responses, and participants' perceptions of effectiveness""]","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0037370', 'cui_str': 'Passive smoking'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205238', 'cui_str': 'True'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0559554,"Efficacy outcomes included a reduction in urinary cotinine, accuracy of true-or-false responses, and participants' perceptions of effectiveness.
","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Nardone', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Department of Medicine, University of California, San Francisco, CA, United States.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Giberson', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Department of Medicine, University of California, San Francisco, CA, United States.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University, Stanford, CA, United States.'}, {'ForeName': 'Shonul', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Department of Pediatrics, Zuckerberg San Francisco General Hospital, University of California, San Francisco, CA, United States.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Clinical Pharmacology Research Program, Division of Cardiology, Department of Medicine, University of California, San Francisco, CA, United States.'}]",JMIR formative research,['10.2196/18583']
2601,32812924,Does empagliflozin modulate the autonomic nervous system among individuals with type 2 diabetes and coronary artery disease? The EMPA-HEART CardioLink-6 Holter analysis.,"Context


We examined if empagliflozin was associated with modulation of cardiac autonomic tone among subjects with type 2 diabetes and stable coronary artery disease (CAD) relative to placebo.
Methods


Using ambulatory 24-h Holter electrocardiographic data prospectively collected from a randomized trial, we compared changes in heart rate variability (HRV) parameters between empagliflozin- and placebo-assigned subjects over a follow-up period of 6 months. Measured HRV domains included: standard deviation (SD) of NN intervals (SDNN), SD of average NN intervals per 5-min (SDANN), root mean square of successive RR interval differences (RMSSD), % successive NN intervals differing >50 ms (ms) (pNN50), low frequency (LF), high frequency (HF) and the LF/HF ratio (LF:HF). Differences in HRV parameters between the 2 groups were compared with analysis of covariance (ANCOVA). Statistical measures of significance were reported as adjusted differences between the 2 groups and their corresponding 95% confidence intervals.
Results


Sixty-six subjects completed 24-h Holter monitoring at baseline and 6-months. Over 6 months, the change in HRV was similar between subjects treated with empagliflozin vs. placebo for the following parameters: RMSSD -1.2 ms (-6.0 to 3.6 ms); pNN50 0.5% (-2.6 to 3.6%); VLF -907.8 ms 2  (-2388.8 to 573.1 ms 2 ); LF -341 ms 2  (-878.7 to 196.7 ms 2 ); HF -33.8 ms 2  (-111.1 to 43.5 ms 2 ); LF:HF -0.1 (-0.4 to 0.2). Subjects who received placebo experienced an increase in SDNN 18.6 ms (2.8-34.3 ms) and SDANN 20.2 ms (3.2-37.3 ms) relative to those treated with empagliflozin.
Conclusion


Compared to placebo, empagliflozin did not result in changes in autonomic tone among individuals with type 2 diabetes and stable coronary artery disease.",2020,"Subjects who received placebo experienced an increase in SDNN 18.6 ms (2.8-34.3 ms) and SDANN 20.2 ms (3.2-37.3 ms) relative to those treated with empagliflozin.
","['subjects with type 2 diabetes and stable coronary artery disease (CAD) relative to placebo', 'individuals with type 2 diabetes and coronary artery disease', 'individuals with type 2 diabetes and stable coronary artery disease']","['empagliflozin', 'empagliflozin- and placebo', 'placebo, empagliflozin', 'LF', 'empagliflozin vs. placebo', 'placebo']","['24-h Holter monitoring', 'HRV parameters', 'heart rate variability (HRV) parameters', 'cardiac autonomic tone', 'Measured HRV domains included: standard deviation (SD) of NN intervals (SDNN), SD of average NN intervals per 5-min (SDANN), root mean square of successive RR interval differences (RMSSD), % successive NN intervals differing >50\xa0ms (ms) (pNN50), low frequency (LF), high frequency (HF) and the LF/HF ratio (LF:HF', 'autonomic tone', 'change in HRV']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0013801', 'cui_str': 'Electrocardiography, Holter'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0523611,"Subjects who received placebo experienced an increase in SDNN 18.6 ms (2.8-34.3 ms) and SDANN 20.2 ms (3.2-37.3 ms) relative to those treated with empagliflozin.
","[{'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Garg', 'Affiliation': ""Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Connelly', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Yan', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Sikand', 'Affiliation': ""Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Ankit', 'Initials': 'A', 'LastName': 'Garg', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorian', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zuo', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute of St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Department of Cardiology, Southlake Regional Health Centre, University of Toronto, Newmarket, ON, Canada.'}, {'ForeName': 'Hwee', 'Initials': 'H', 'LastName': 'Teoh', 'Affiliation': ""Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Quan', 'Affiliation': ""Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St Michael's Hospital, Unity Health Toronto, Toronto, ON, Canada.""}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Mazer', 'Affiliation': 'Department of Physiology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Andrew C T', 'Initials': 'ACT', 'LastName': 'Ha', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada.'}]",Metabolism open,['10.1016/j.metop.2020.100039']
2602,32812942,Endogenous versus exogenous carbohydrate oxidation measured by stable isotopes in pre-pubescent children plus  13 C abundances in foods consumed three days prior.,"Purpose


The purposes of the present study were to (a) examine resting metabolism, substrate utilization, and endogenous versus exogenous carbohydrate (CHO) oxidation before and after 30-g rapidly-digesting carbohydrate (RDC) ingestion using indirect calorimetry and breath test analysis of stable isotope concentrations in pre-pubescent children and (b) report the  13 C abundances in foods consumed for three days prior.
Methods


Nineteen children (n = 10 boys, n = 9 girls) at Tanner stage I or II participated (mean age ± 95% CI = 9.84 ± 0.77 y) in this study. Food was administered to the children for three days preceding their scheduled breath tests. Breath tests and indirect calorimetry were performed after an 8-h fast before and 60 min following consumption of a 30-g simple RDC drink consisting of maltodextrin and sucrose. Open circuit spirometry and indirect calorimetry monitored resting metabolism and CHO oxidation. Separate breath samples were taken every 15 min. Samples of all foods and breath samples were analyzed for  13 C and  12 C abundances with a stable-isotope mass spectrometer.
Results


13 C in expired breath samples were -23.81 ± 1.64‰ at baseline and increased every 15 min after consumption of the CHO drink (p < 0.001-0.009). Cumulative total, endogenous, and exogenous CHO utilization increased during the post-prandial period (p < 0.001). Endogenous CHO oxidation was consistently greater than exogenous CHO oxidation (p < 0.001-0.002).Blood glucose was elevated from baseline at 30- and 60-min post-prandial (p < 0.001). Insulin did not change over time (p = 0.184).
Conclusions


The foods provided during the 3-day controlled diet effectively minimized  13 C variation prior to metabolic testing. The  13 C abundances of foods reported herein should serve as practical recommendations to reduce  13 C intake before breath tests. While endogenous CHO oxidation remained greater in proportion to exogenous CHO oxidation, these findings suggest that even a relatively small amount of RDC can increase exogenous CHO oxidation and blood glucose in normal-weight children. To further examine shifts in endogenous versus exogenous CHO utilization, we recommend that future studies take steps to minimize  13 C variation before breath tests and examine changes in substrate metabolism at rest and during exercise in normal weight and overweight pre-pubescent children.
Clinical trial registration number


NCT03185884.",2020,Endogenous CHO oxidation was consistently greater than exogenous CHO oxidation (p < 0.001-0.002).Blood glucose was elevated from baseline at 30- and 60-min post-prandial (p < 0.001).,"['Nineteen children (n\xa0=\xa010 boys, n\xa0=\xa09 girls) at Tanner stage', 'pre-pubescent children and (b) report the  13 C abundances in foods consumed for three days prior', 'normal-weight children']","['maltodextrin and sucrose', 'Endogenous versus exogenous carbohydrate oxidation']","['resting metabolism, substrate utilization, and endogenous versus exogenous carbohydrate (CHO) oxidation', 'exogenous CHO oxidation', 'Cumulative total, endogenous, and exogenous CHO utilization', 'exogenous CHO oxidation and blood glucose', 'expired breath samples', 'Endogenous CHO oxidation']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0335730', 'cui_str': 'Tanner'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0729631', 'cui_str': 'Carbon-13'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}]","[{'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",19.0,0.0315979,Endogenous CHO oxidation was consistently greater than exogenous CHO oxidation (p < 0.001-0.002).Blood glucose was elevated from baseline at 30- and 60-min post-prandial (p < 0.001).,"[{'ForeName': 'Marni E', 'Initials': 'ME', 'LastName': 'Shoemaker', 'Affiliation': 'College of Health Sciences, The University of Texas at El Paso, El Paso, TX, 79968, United States.'}, {'ForeName': 'Zachary M', 'Initials': 'ZM', 'LastName': 'Gillen', 'Affiliation': 'Department of Nutrition and Health Sciences, University of Nebraska-Lincoln, Lincoln, NE, 68583, United States.'}, {'ForeName': 'Brianna D', 'Initials': 'BD', 'LastName': 'Mckay', 'Affiliation': 'Department of Nutrition and Health Sciences, University of Nebraska-Lincoln, Lincoln, NE, 68583, United States.'}, {'ForeName': 'Todd J', 'Initials': 'TJ', 'LastName': 'Leutzinger', 'Affiliation': 'Department of Nutrition and Health Sciences, University of Nebraska-Lincoln, Lincoln, NE, 68583, United States.'}, {'ForeName': 'Vikkie A', 'Initials': 'VA', 'LastName': 'Mustad', 'Affiliation': 'Abbott Nutrition, 2900 Easton Square Place, Columbus, OH, 43219, United States.'}, {'ForeName': 'Joel T', 'Initials': 'JT', 'LastName': 'Cramer', 'Affiliation': 'College of Health Sciences, The University of Texas at El Paso, El Paso, TX, 79968, United States.'}]",Metabolism open,['10.1016/j.metop.2020.100041']
2603,32812964,Protective effect of a dietary flavonoid-rich antioxidant from bamboo leaves against internal exposure to acrylamide and glycidamide in humans.,"Polyphenolic antioxidants may effectively reduce acrylamide contents in processed foods. However, few studies focused on their detoxification effects via estimating the profile change of internal exposure biomarkers. Here we showed the protective effect of a water-soluble flavone-C-glycoside-rich antioxidant from bamboo leaves (AOB-w) against acrylamide-induced toxicity in college students. The participants were randomly assigned to either the AOB-w or control group and served potato chips, corresponding to 12.6 μg per kg·bw of dietary exposure to acrylamide, followed by capsules containing 350 mg AOB-w or equivalent placebo. The kinetics of acrylamide, glycidamide, and mercapturic acid metabolites was profiled, and their hemoglobin adducts were measured. The toxicokinetic study showed that AOB-w promoted the excretion of acrylamide and shortened the distribution but prolonged the excretion of N-acetyl-S-(2-carbamoylethyl)-l-cysteine (AAMA) and N-acetyl-S-(2-carbamoyl-2-hydroxyethyl)-l-cysteine. The intervention with AOB-w reduced the peak concentration and area under curve of AAMA by 42.1% and 49.8%, respectively. Besides, AOB-w gender-dependently altered the toxicokinetic profile and reduced the amount of a human-specific urinary biomarker, N-acetyl-S-(2-carbamoylethyl)-l-cysteine-sulfoxide in women. AOB-w accelerated the metabolism of hemoglobin adducts of acrylamide and glycidamide in blood of women. Compared with the baseline levels on the beginning day, we observed a significant enhancement of hemoglobin adducts on the 10th day after serving them potato chips, showing 54.5% and 20.9% higher levels of the hemoglobin adducts of acrylamide and glycidamide, respectively, which thus indicated a lower level of glycidamide-to-acrylamide ratio in blood of participants. Overall AOB-w could effectively reduce the internal exposure to acrylamide in college students, which provides advanced insights into protective functions of natural antioxidants against in vivo toxicity of chemical contaminants from diet.",2020,AOB-w accelerated the metabolism of hemoglobin adducts of acrylamide and glycidamide in blood of women.,"['college students', 'humans']","['water-soluble flavone-C-glycoside-rich antioxidant from bamboo leaves (AOB-w) against acrylamide-induced toxicity', 'AOB-w or control group and served potato chips, corresponding to 12.6 μg per kg·bw of dietary exposure to acrylamide, followed by capsules containing 350 mg AOB-w or equivalent placebo', 'dietary flavonoid-rich antioxidant', 'Polyphenolic antioxidants']","['excretion of acrylamide', 'kinetics of acrylamide, glycidamide, and mercapturic acid metabolites', 'peak concentration and area under curve of AAMA', 'hemoglobin adducts']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0016219', 'cui_str': '2-Phenyl-2-Ene-Benzopyran-4-One Compounds'}, {'cui': 'C1098835', 'cui_str': 'C-glycoside'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C1337281', 'cui_str': 'Bamboo extract'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0266060', 'cui_str': 'Anterior open bite'}, {'cui': 'C0001218', 'cui_str': 'Acrylamides'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0349380', 'cui_str': 'Potato chips'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C4505221', 'cui_str': 'Dietary Exposure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0596577', 'cui_str': 'Flavonoid'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0001218', 'cui_str': 'Acrylamides'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0119706', 'cui_str': 'glycidamide'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0414835,AOB-w accelerated the metabolism of hemoglobin adducts of acrylamide and glycidamide in blood of women.,"[{'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Zhejiang Key Laboratory for Agro-Food Processing, Key Laboratory of Agro-Products Postharvest Handling of Ministry of Agriculture and Rural Affairs, College of Biosystems Engineering and Food Science, Zhejiang University, Hangzhou 310058, Zhejiang, China. y_zhang@zju.edu.cn yzhang@zju.edu.cn.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jia', 'Affiliation': ''}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Jianxin', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Weijiang', 'Initials': 'W', 'LastName': 'Zeng', 'Affiliation': ''}, {'ForeName': 'Qingning', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': ''}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ''}]",Food & function,['10.1039/d0fo00811g']
2604,32817889,Empathetic listening boosts nostalgia levels and positive emotions in autobiographical narrators.,"Nostalgic memories serve to increase human resilience. Here, we hypothesized that emotional impressions on a narrator's nostalgic memory change depending on the level of empathy in the listener's response. This independent-measures study was conducted in 120 healthy Japanese undergraduates (66 women, 54 men,  M   age  20.3 ± 1.9 years). Nostalgia was induced using a medley of Japanese pop songs from the years 2006-2010. Thirty minutes later each participant was randomly allocated to be interviewed by an experimenter who applied one of three listening conditions: empathy, non-empathy, or non-response. Output measures were participant's talking time, nostalgia ratings, and positive and negative emotion ratings. Data were analyzed by analysis of variance followed by a multiple comparisons test. Empathy group participants had a significantly longer talking time than non-empathy or non-response participants, higher nostalgia scores than non-response participants, and higher positive emotion scores than non-empathy and non-response participants, but lower negative emotion scores than non-reponse participants. Participants were then divided into a less nostalgia-prone and a more nostalgia-prone group using the Southampton Nostalgia Rating Scale and the data were reanalyzed for each experimental condition. The results showed that a person more prone to nostalgia felt more nostalgic and more positive toward their autobiographical memory than those who are less nostalgia-prone. The present findings have implications for human interaction in everyday life and in therapeutic settings.",2020,"Empathy group participants had a significantly longer talking time than non-empathy or non-response participants, higher nostalgia scores than non-response participants, and higher positive emotion scores than non-empathy and non-response participants, but lower negative emotion scores than non-reponse participants.","['autobiographical narrators', '120 healthy Japanese undergraduates (66 women, 54 men,  M   age  20.3 ± 1.9 years']","['experimenter who applied one of three listening conditions: empathy, non-empathy, or non-response']","['talking time, nostalgia ratings, and positive and negative emotion ratings', 'autobiographical memory', 'Southampton Nostalgia Rating Scale', 'nostalgia scores', 'longer talking time', 'negative emotion scores', 'positive emotion scores']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.0254509,"Empathy group participants had a significantly longer talking time than non-empathy or non-response participants, higher nostalgia scores than non-response participants, and higher positive emotion scores than non-empathy and non-response participants, but lower negative emotion scores than non-reponse participants.","[{'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Sugimori', 'Affiliation': 'Faculty of Human Sciences, Waseda University, Japan.'}, {'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Shimokawa', 'Affiliation': 'Graduate School of Human Science, Waseda University, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Aoyama', 'Affiliation': 'Faculty of Human Sciences, Waseda University, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Kita', 'Affiliation': 'Faculty of Human Sciences, Waseda University, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kusumi', 'Affiliation': 'Graduate School of Education, Kyoto University, Japan.'}]",Heliyon,['10.1016/j.heliyon.2020.e04536']
2605,32817905,A pre-trial evaluation of blinding for a Chinese herbal medicine trial.,"Background


Blinding is considered an important methodological characteristic in clinical trials to minimise bias and maximise the validity of a trial. Unlike pharmaceutical substances, most herbal medicines have distinctive sensory specifications, including odour and taste, which can be quite challenging when developing a placebo control to match the specific characteristics of herbal substances being examined. The present study was, therefore, designed to evaluate whether the participants could differentiate an active herbal capsule (Ganopoly combination) from a placebo material capsule. The aim of this study was to develop a suitable placebo substance for encapsulation to be used in a future herbal medicine clinical trial.
Methods


The current study was improved upon the previous investigation, and several modifications were made to the placebo substance in order to mimic the herbal substance characteristics. Prior to conducting the study, a refined placebo substance was developed using commonly consumed culinary agents. Sixty-two healthy volunteers participated in the study and were randomly provided one of the two substances. Individuals were asked to evaluate the three sensory characteristics of the allocated capsule (visual appearance, odour, and taste), and determine whether they believed the substance to be a 'herbal' or a 'placebo' substance.
Results


The study provided evidence on the success of blinding for only two sensory characteristics, namely, visual appearance (95% CI -0.15, 0.34) and odour (95% CI -0.34, 0.15). In contrast, the findings related to the taste indicated that participants correctly guessed the herbal substance compared to the placebo substance to a significantly higher proportion than would have been expected by chance alone (95% CI 0.14, 0.60).
Conclusion


The failure to blind participants for taste highlights the difficulties in preparing placebo herbal substances that match as closely as possible to a real herbal substance. Blinding is particularly challenging where herbal medicines have different sensory characteristics.",2020,"In contrast, the findings related to the taste indicated that participants correctly guessed the herbal substance compared to the placebo substance to a significantly higher proportion than would have been expected by chance alone (95% CI 0.14, 0.60).
",['Sixty-two healthy volunteers'],"['placebo substance', ""placebo' substance"", 'placebo material capsule']",[],"[{'cui': 'C4517835', 'cui_str': '62'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]",[],62.0,0.600932,"In contrast, the findings related to the taste indicated that participants correctly guessed the herbal substance compared to the placebo substance to a significantly higher proportion than would have been expected by chance alone (95% CI 0.14, 0.60).
","[{'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Razavy', 'Affiliation': 'School of Life Sciences, University of Technology Sydney, 2007, New South Wales, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'School of Life Sciences, University of Technology Sydney, 2007, New South Wales, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Zaslawski', 'Affiliation': 'School of Life Sciences, University of Technology Sydney, 2007, New South Wales, Australia.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100632']
2606,32813051,The emotional impact of the COVID-19 pandemic on individuals with progressive multiple sclerosis.,"OBJECTIVE


Individuals with pre-existing chronic illness have shown increased anxiety and depression due to COVID-19. Here, we examine the impact of the COVID-19 pandemic on emotional symptomatology and quality of life in individuals with Progressive Multiple Sclerosis (PMS).
METHODS


Data were obtained during a randomized clinical trial on rehabilitation taking place at 11 centers in North America and Europe. Participants included 131 individuals with PMS. Study procedures were interrupted in accordance with governmental restrictions as COVID-19 spread. During study closure, a COVID Impact Survey was administered via telephone or email to all participants, along with measures of depressive symptoms, anxiety symptoms, quality of life, and MS symptomatology that were previously administered pre-pandemic.
RESULTS


4% of respondents reported COVID-19 infection. No significant changes were noted in anxiety, quality of life, or the impact of MS symptomatology on daily life from baseline to lockdown. While total HADS-depression scores increased significantly at follow-up, this did not translate into more participants scoring above the HADS threshold for clinically significant depression. No significant relationships were noted between disease duration, processing speed ability or EDSS, and changes in symptoms of depression or anxiety. Most participants reported the impact of the virus on their psychological well-being, with a little impact on financial well-being. The perceived impact of the pandemic on physical and psychological well-being was correlated with the impact of MS symptomatology on daily life, as well as changes in depression.
CONCLUSIONS


Overall, little change was noted in symptoms of depression or anxiety or overall quality of life.",2020,"No significant changes were noted in anxiety, quality of life, or the impact of MS symptomatology on daily life from baseline to lockdown.","['Individuals with pre-existing chronic illness', 'Participants included 131 individuals with PMS', 'individuals with progressive multiple sclerosis', 'at 11 centers in North America and Europe', 'individuals with Progressive Multiple Sclerosis (PMS']","['COVID-19 pandemic', 'rehabilitation taking place']","['symptoms of depression or anxiety or overall quality of life', 'COVID-19 infection', 'disease duration, processing speed ability or EDSS, and changes in symptoms of depression or anxiety', 'emotional symptomatology and quality of life', 'total HADS-depression scores', 'anxiety, quality of life, or the impact of MS symptomatology on daily life', 'depressive symptoms, anxiety symptoms, quality of life, and MS symptomatology']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",131.0,0.19236,"No significant changes were noted in anxiety, quality of life, or the impact of MS symptomatology on daily life from baseline to lockdown.","[{'ForeName': 'Nancy D', 'Initials': 'ND', 'LastName': 'Chiaravalloti', 'Affiliation': 'Kessler Foundation, 120 Eagle Rock Avenue, Suite 100, East Hanover, NJ, 07936, USA. nchiaravalloti@kesslerfoundation.org.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Amato', 'Affiliation': 'Department NEUROFARBA, Section Neurosciences, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Brichetto', 'Affiliation': 'Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), via Operai 40, 16149, Genoa, Italy.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Chataway', 'Affiliation': 'Department of Neuroinflammation, UCL Queen Square Institute of Neurology, Faculty of Brain Sciences, Queen Square Multiple Sclerosis Centre, University College London, London, WC1B 5EH, UK.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Dalgas', 'Affiliation': 'Exercise Biology, Department of Public Health, Aarhus University, Dalgas Avenue 4, 8000, Aarhus, Denmark.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeLuca', 'Affiliation': 'Kessler Foundation, 120 Eagle Rock Avenue, Suite 100, East Hanover, NJ, 07936, USA.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Meza', 'Affiliation': 'Department of Psychiatry, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, M5R 3B6, Canada.'}, {'ForeName': 'Nancy B', 'Initials': 'NB', 'LastName': 'Moore', 'Affiliation': 'Kessler Foundation, 120 Eagle Rock Avenue, Suite 100, East Hanover, NJ, 07936, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Feys', 'Affiliation': 'REVAL, Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Filippi', 'Affiliation': 'Division of Neuroscience, Neuroimaging Research Unit, Institute of Experimental Neurology, IRCSS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Freeman', 'Affiliation': 'Faculty of Health, School of Health Professions, University of Plymouth, Devon, UK.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Inglese', 'Affiliation': 'Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, and Center of Excellence for Biomedical Research, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, USA.'}, {'ForeName': 'Maria Assunta', 'Initials': 'MA', 'LastName': 'Rocca', 'Affiliation': 'Division of Neuroscience, Neuroimaging Research Unit, Institute of Experimental Neurology, IRCSS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Sandroff', 'Affiliation': 'Kessler Foundation, 120 Eagle Rock Avenue, Suite 100, East Hanover, NJ, 07936, USA.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Salter', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Cutter', 'Affiliation': 'Department of Biostatistics, University of Alabama At Birmingham, Birmingham, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Feinstein', 'Affiliation': 'Department of Psychiatry, University of Toronto and Sunnybrook Health Sciences Centre, Toronto, ON, M5R 3B6, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-020-10160-7']
2607,32813124,Chest shielding in preterm neonates under phototherapy-a randomised control trial.,"Shielding the precordium can effect manifestation of haemodynamically significant patent ductus arteriosus (hsPDA). Preterm neonates born at ≤ 32 weeks of gestation if needed phototherapy within 72 h of birth and had no echocardiographically proven hsPDA were eligible to be enrolled in this open-label randomised controlled trial. In chest shielding group, in addition to the standard care, left side of the chest was covered using food grade aluminium foil during phototherapy while control group received standard care. Mean gestational age (weeks; 30.1 ± 1.5 vs 30.1 ± 1.6) was comparable in the two groups. However, neonates in the chest shield group had lower birth weight (g; 1281 ± 259 vs 1422 ± 307) and were more likely to be small-for-gestational age (21.6% vs 8.0%). It was seen that 4 (7.8%) babies in the chest shield group and 5 (10%) babies in the standard group developed hsPDA after starting phototherapy with relative risk (RR) of 0.78 (95% CI 0.22-2.75). The left atrium to aortic ratio was significantly different in the two groups with 1.5 ± 0.1 in the chest shield group and 1.8 ± 0.2 in standard group (p value 0.03).Conclusion: Chest shielding of preterm babies during phototherapy has no effect on the incidence of haemodynamically significant patent ductus arteriosus.Trial registration: Trial was registered with Clinical trial registry of India (CTRI/2018/01/011069). What is Known: • Chest shielding in preterm neonates under phototherapy has inconclusive effect on the manifestation of patent ductus arteriosus. What is New: • Preterm neonates under phototherapy have no significant difference in manifestation of haemodynamically significant patent ductus arteriosus if precordium is shielded.",2020,• Preterm neonates under phototherapy have no significant difference in manifestation of haemodynamically significant patent ductus arteriosus if precordium is shielded.,"['preterm neonates under', 'Preterm neonates born at ≤\u200932\xa0weeks of gestation if needed phototherapy within 72\xa0h of birth and had no echocardiographically proven hsPDA', 'Mean gestational age (weeks; 30.1\u2009±\u20091.5 vs 30.1\u2009±\u20091.6', 'haemodynamically significant patent ductus arteriosus (hsPDA']",['phototherapy'],"['manifestation of haemodynamically significant patent ductus arteriosus', 'left atrium to aortic ratio', 'hsPDA', 'lower birth weight', 'incidence of haemodynamically significant patent ductus arteriosus']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C4517508', 'cui_str': '1.6'}]","[{'cui': 'C0031765', 'cui_str': 'Light therapy'}]","[{'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013274', 'cui_str': 'Patent ductus arteriosus'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0003483', 'cui_str': 'Aortic'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.133377,• Preterm neonates under phototherapy have no significant difference in manifestation of haemodynamically significant patent ductus arteriosus if precordium is shielded.,"[{'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Kapoor', 'Affiliation': 'Department of Neonatology, Government Medical College and Hospital, Sector32, Chandigarh, 160030, India.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Mishra', 'Affiliation': 'Department of Neonatology, Government Medical College and Hospital, Sector32, Chandigarh, 160030, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Chawla', 'Affiliation': 'Department of Neonatology, Government Medical College and Hospital, Sector32, Chandigarh, 160030, India.'}, {'ForeName': 'Suksham', 'Initials': 'S', 'LastName': 'Jain', 'Affiliation': 'Department of Neonatology, Government Medical College and Hospital, Sector32, Chandigarh, 160030, India. dr.sukshamj@gmail.com.'}]",European journal of pediatrics,['10.1007/s00431-020-03763-9']
2608,32813130,Botulinum Toxin Type A Injection for Mammoplasty and Abdominoplasty Scar Management: A Split-Scar Double-Blinded Randomized Controlled Study.,"BACKGROUND


Scars are inevitable results of surgical procedures, and prevention of them is still a major problem in the field of cosmetic surgery. Although various studies have been performed on botulinum toxin-A (BoNT-A) injection for the prevention of hypertrophic scars, the exact mechanism remains unclear.
METHODS


This prospective, double-blinded, randomized study was performed on 19 patients who underwent mammoplasty and abdominoplasty surgery in Razi Hospital from October 2018 to December 2019. Single session of treatment was performed, where XEOMIN was allocated to one half of the scar and 0.9% saline to the control half. 3 and 6 months later, scars were assessed using the modified Stony Brook Scar Evaluation Scale (SBSES).
RESULTS


In total, 19 patients who completed the study were analyzed. mSBSES at the third month (P value < 0.001; 3.34 ± 1.59 vs 1.5 ± 1.36) and the sixth month (P value < 0.001; 4.89 ± 1.83 vs 2.39 ± 1.82) showed a significant difference between the treatment and control groups. In the subset analysis, there was significant difference between BoNT-A and control in all four items including width, height, color, and scar visibility at months 3 and 6, and the BoNT-A-treated sides had higher scores in all items.
CONCLUSION


BoNT-A has a significant effect on scar prevention due to mammoplasty and abdominoplasty compared to placebo and results in decreased erythema, height, width and reduces incision line visibility. Moreover, its effect increases significantly over time from months 3 to 6.
LEVEL OF EVIDENCE II


This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .",2020,mSBSES at the third month (P value < 0.001; 3.34 ± 1.59 vs 1.5 ± 1.36) and the sixth month (P value < 0.001; 4.89 ± 1.83 vs 2.39 ± 1.82) showed a significant difference between the treatment and control groups.,"['Mammoplasty and Abdominoplasty Scar Management', '19 patients who underwent mammoplasty and abdominoplasty surgery in Razi Hospital from October 2018 to December 2019', '19 patients who completed the study were analyzed']","['placebo', 'botulinum toxin-A (BoNT-A) injection', 'Botulinum Toxin Type A Injection']","['width, height, color, and scar visibility', 'modified Stony Brook Scar Evaluation Scale (SBSES', 'scar prevention', 'erythema, height, width and reduces incision line visibility']","[{'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0556498', 'cui_str': 'Scar management'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4060200', 'cui_str': 'Botulinum Toxin Type A Injection [Botox]'}]","[{'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",19.0,0.112017,mSBSES at the third month (P value < 0.001; 3.34 ± 1.59 vs 1.5 ± 1.36) and the sixth month (P value < 0.001; 4.89 ± 1.83 vs 2.39 ± 1.82) showed a significant difference between the treatment and control groups.,"[{'ForeName': 'Robabeh', 'Initials': 'R', 'LastName': 'Abedini', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Vahdate Eslami Street, 1199663911, Tehran, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Mehdizade Rayeni', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Vahdate Eslami Street, 1199663911, Tehran, Iran.'}, {'ForeName': 'Shahriar', 'Initials': 'S', 'LastName': 'Haddady Abianeh', 'Affiliation': 'Ophthalmic Plastic and Reconstructive Surgery, Department of General Surgery, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Rahmati', 'Affiliation': 'Ophthalmic Plastic and Reconstructive Surgery, Department of General Surgery, Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Teymourpour', 'Affiliation': 'School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Nasimi', 'Affiliation': 'Department of Dermatology, Razi Hospital, Tehran University of Medical Sciences, Vahdate Eslami Street, 1199663911, Tehran, Iran. Nsm.maryam@gmail.com.'}]",Aesthetic plastic surgery,['10.1007/s00266-020-01916-7']
2609,32813171,Comparison of three tonsillectomy techniques in children.,"PURPOSE


Tonsillectomy is still one of the most common surgical procedures worldwide performed by otorhinolaryngologists. This single-blind randomized study aimed to compare cold dissection tonsillectomy, coblation tonsillectomy, and harmonic scalpel tonsillectomy in pediatric patients in respect of intraoperative blood loss, operating time, and postoperative pain and bleeding.
METHODS


This single-blind randomized clinical trial evaluated 82 pediatric patients aged 3-16 years (mean age: 7.23 ± 3.26 years) applied with tonsillectomy between April 2017 and March 2020. Harmonic scalpel tonsillectomy was applied to 33 (40.2%) patients, the cold knife technique to 25 (30.5%), and coblation tonsillectomy to 24 (29.3%).
RESULTS


There was no statistically significant difference between the three techniques in respect of postoperative pain levels and post-tonsillectomy bleeding rates. The intraoperative bleeding rate and mean operating time were determined to be significantly lower in the harmonic scalpel group (p < 0.05).
CONCLUSION


Harmonic scalpel tonsillectomy is associated with a shorter operating time and lower intraoperative bleeding rates and similar postoperative pain score and postoperative bleeding rates compared with coblation tonsillectomy and cold dissection tonsillectomy. Harmonic scalpel tonsillectomy is a fast, safe, and effective method for tonsillectomy in children.",2020,There was no statistically significant difference between the three techniques in respect of postoperative pain levels and post-tonsillectomy bleeding rates.,"['82 pediatric patients aged 3-16\xa0years (mean age: 7.23\u2009±\u20093.26\xa0years) applied with tonsillectomy between April 2017 and March 2020', 'pediatric patients', 'children']","['coblation tonsillectomy and cold dissection tonsillectomy', 'cold dissection tonsillectomy, coblation tonsillectomy, and harmonic scalpel tonsillectomy', 'cold knife technique', 'Harmonic scalpel tonsillectomy']","['postoperative pain levels and post-tonsillectomy bleeding rates', 'intraoperative blood loss, operating time, and postoperative pain and bleeding', 'shorter operating time and lower intraoperative bleeding rates and similar postoperative pain score and postoperative bleeding rates', 'intraoperative bleeding rate and mean operating time']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1960390', 'cui_str': 'Plasma mediated ablation tonsillectomy'}, {'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0396306', 'cui_str': 'Dissection tonsillectomy'}, {'cui': 'C0392220', 'cui_str': 'Scalpel'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",82.0,0.0256616,There was no statistically significant difference between the three techniques in respect of postoperative pain levels and post-tonsillectomy bleeding rates.,"[{'ForeName': 'Bugra', 'Initials': 'B', 'LastName': 'Subasi', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Kutahya Health Sciences University, 43000, Kütahya, Turkey. drbugrasubasi@hotmail.com.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Oghan', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Kutahya Health Sciences University, 43000, Kütahya, Turkey.'}, {'ForeName': 'Hamdi', 'Initials': 'H', 'LastName': 'Tasli', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Kutahya Health Sciences University, 43000, Kütahya, Turkey.'}, {'ForeName': 'Seckin', 'Initials': 'S', 'LastName': 'Akbal', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Kutahya Health Sciences University, 43000, Kütahya, Turkey.'}, {'ForeName': 'Nesibe Esra', 'Initials': 'NE', 'LastName': 'Karaman', 'Affiliation': 'Faculty of Medicine, Department of Otorhinolaryngology, Kutahya Health Sciences University, 43000, Kütahya, Turkey.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06299-8']
2610,32813279,Retzius-sparing versus standard robotic-assisted laparoscopic prostatectomy for the treatment of clinically localized prostate cancer.,"BACKGROUND


Robotic-assisted laparoscopic prostatectomy (RALP) is widely used to surgically treat clinically localized prostate cancer. It is typically performed using an approach (standard RALP) that mimics open retropubic prostatectomy by dissecting the so-called space of Retzius anterior to the bladder. An alternative, Retzius-sparing (or posterior approach) RALP (RS-RALP) has been described, which is reported to have better continence outcomes but may be associated with a higher risk of incomplete resection and positive surgical margins (PSM).
OBJECTIVES


To assess the effects of RS-RALP compared to standard RALP for the treatment of clinically localized prostate cancer.
SEARCH METHODS


We performed a comprehensive search of the Cochrane Library, MEDLINE, Embase, three other databases, trials registries, other sources of the grey literature, and conference proceedings, up to June 2020. We applied no restrictions on publication language or status.
SELECTION CRITERIA


We included trials where participants were randomized to RS-RALP or standard RALP for clinically localized prostate cancer.
DATA COLLECTION AND ANALYSIS


Two review authors independently classified and abstracted data from the included studies. Primary outcomes were: urinary continence recovery within one week after catheter removal, at three months after surgery, and serious adverse events. Secondary outcomes were: urinary continence recovery six and 12 months after surgery, potency recovery 12 months after surgery, positive surgical margins (PSM), biochemical recurrence-free survival (BCRFS), and urinary and sexual function quality of life. We performed statistical analyses using a random-effects model. We rated the certainty of evidence using the GRADE approach.
MAIN RESULTS


Our search identified six records of five unique randomized controlled trials, of which two were published studies, one was in press, and two were abstract proceedings. There were 571 randomized participants, of whom 502 completed the trials. Mean age of participants was 64.6 years and mean prostate-specific antigen was 6.9 ng/mL. About 54.2% of participants had cT1c disease, 38.6% had cT2a-b disease, and 7.1 % had cT2c disease. Primary outcomes RS-RALP probably improves continence within one week after catheter removal (risk ratio (RR) 1.74, 95% confidence interval (CI) 1.41 to 2.14; I 2  = 0%; studies = 4; participants = 410; moderate-certainty evidence). Assuming 335 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 248 more men per 1000 (137 more to 382 more) reporting continence recovery. RS-RALP may increase continence at three months after surgery compared to standard RALP (RR 1.33, 95% CI 1.06 to 1.68; I 2  = 86%; studies = 5; participants = 526; low-certainty evidence). Assuming 750 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 224 more men per 1000 (41 more to 462 more) reporting continence recovery. We are very uncertain about the effects of RS-RALP on serious adverse events compared to standard RALP (RR 1.40, 95% CI 0.47 to 4.17; studies = 2; participants = 230; very low-certainty evidence). Secondary outcomes There is probably little to no difference in continence recovery at 12 months after surgery (RR 1.01, 95% CI 0.97 to 1.04; I 2  = 0%; studies = 2; participants = 222; moderate-certainty evidence). Assuming 982 per 1000 men undergoing standard RALP are continent at this time point, this corresponds to 10 more men per 1000 (29 fewer to 39 more) reporting continence recovery.  We are very uncertain about the effect of RS-RALP on potency recovery 12 months after surgery (RR 0.98, 95% CI 0.54 to 1.80; studies = 1; participants = 55; very low-certainty evidence).  RS-RALP may increase PSMs (RR 1.95, 95% CI 1.19 to 3.20; I 2  = 0%; studies = 3; participants = 308; low-certainty evidence) indicating a higher risk for prostate cancer recurrence. Assuming 129 per 1000 men undergoing standard RALP have positive margins, this corresponds to 123 more men per 1000 (25 more to 284 more) with PSMs. We are very uncertain about the effect of RS-RALP on BCRFS compared to standard RALP (hazard ratio (HR) 0.45, 95% CI 0.13 to 1.60; I 2  = 32%; studies = 2; participants = 218; very low-certainty evidence).
AUTHORS' CONCLUSIONS


Findings of this review indicate that RS-RALP may result in better continence outcomes than standard RALP up to six months after surgery. Continence outcomes at 12 months may be similar. Downsides of RS-RALP may be higher positive margin rates. We are very uncertain about the effect on BCRFS and potency outcomes. Longer-term oncologic and functional outcomes are lacking, and no preplanned subgroup analyses could be performed to explore the observed heterogeneity. Surgeons should discuss these trade-offs and the limitations of the evidence with their patients when considering this approach.",2020,"RS-RALP may increase continence at three months after surgery compared to standard RALP (RR 1.33, 95% CI 1.06 to 1.68; I 2  = 86%; studies = 5; participants = 526; low-certainty evidence).","['clinically localized prostate cancer', 'Assuming 982\xa0per 1000 men undergoing', 'Assuming 129\xa0per 1000 men undergoing standard RALP have positive margins, this corresponds to 123 more men per 1000 (25 more to 284 more) with PSMs', 'Assuming 750\xa0per 1000 men undergoing', 'Assuming 335 per 1000 men undergoing', '571 randomized participants, of whom 502 completed the trials', 'Mean age of participants was 64.6 years and mean prostate-specific antigen was 6.9 ng/mL']","['Retzius-sparing versus standard robotic-assisted laparoscopic prostatectomy', 'RS-RALP', 'standard RALP', 'Retzius-sparing (or posterior approach) RALP (RS-RALP', 'RS-RALP or standard RALP', 'Robotic-assisted laparoscopic prostatectomy (RALP']","['urinary continence recovery', 'serious adverse events', 'continence within one week after catheter removal (risk ratio (RR', 'urinary continence recovery six and 12 months after surgery, potency recovery 12 months after surgery, positive surgical margins (PSM),\xa0biochemical recurrence-free survival (BCRFS), and urinary and sexual function quality of life', 'continence recovery', 'PSMs', 'Continence outcomes']","[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C1310550', 'cui_str': 'Pteroylpoly-gamma-glutamate carboxypeptidase'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C4517826', 'cui_str': '6.9'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0205512', 'cui_str': 'Posterior approach'}]","[{'cui': 'C0542565', 'cui_str': 'Bladder control'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1709603', 'cui_str': 'Positive Surgical Margins'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1310550', 'cui_str': 'Pteroylpoly-gamma-glutamate carboxypeptidase'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",571.0,0.310431,"RS-RALP may increase continence at three months after surgery compared to standard RALP (RR 1.33, 95% CI 1.06 to 1.68; I 2  = 86%; studies = 5; participants = 526; low-certainty evidence).","[{'ForeName': 'Joel E', 'Initials': 'JE', 'LastName': 'Rosenberg', 'Affiliation': 'University of Minnesota Medical School, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Jae Hung', 'Initials': 'JH', 'LastName': 'Jung', 'Affiliation': 'Department of Urology, Yonsei University Wonju College of Medicine, Wonju, Korea, South.'}, {'ForeName': 'Zach', 'Initials': 'Z', 'LastName': 'Edgerton', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Hunju', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea, South.'}, {'ForeName': 'Solam', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea, South.'}, {'ForeName': 'Caitlin J', 'Initials': 'CJ', 'LastName': 'Bakker', 'Affiliation': 'Health Sciences Libraries, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Dahm', 'Affiliation': 'Department of Urology, University of Minnesota, Minneapolis, Minnesota, USA.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013641.pub2']
2611,32813290,Working memory training restores aberrant brain activity in adult attention-deficit hyperactivity disorder.,"The development of treatments for attention impairments is hampered by limited knowledge about the malleability of underlying neural functions. We conducted the first randomized controlled trial to determine the modulations of brain activity associated with working memory (WM) training in adults with attention-deficit hyperactivity disorder (ADHD). At baseline, we assessed the aberrant functional brain activity in the n-back WM task by comparing 44 adults with ADHD with 18 healthy controls using fMRI. Participants with ADHD were then randomized to train on an adaptive dual n-back task or an active control task. We tested whether WM training elicits redistribution of brain activity as observed in healthy controls, and whether it might further restore aberrant activity related to ADHD. As expected, activity in areas of the default-mode (DMN), salience (SN), sensory-motor (SMN), frontoparietal (FPN), and subcortical (SCN) networks was decreased in participants with ADHD at pretest as compared with healthy controls, especially when the cognitive load was high. WM training modulated widespread FPN and SN areas, restoring some of the aberrant activity. Training effects were mainly observed as decreased brain activity during the trained task and increased activity during the untrained task, suggesting different neural mechanisms for trained and transfer tasks.",2020,"Training effects were mainly observed as decreased brain activity during the trained task and increased activity during the untrained task, suggesting different neural mechanisms for trained and transfer tasks.","['44 adults with ADHD with 18 healthy controls using fMRI', 'Participants with ADHD', 'adults with attention-deficit hyperactivity disorder (ADHD', 'adult attention-deficit hyperactivity disorder', 'healthy controls']","['working memory (WM) training', 'WM training', 'Working memory training', 'adaptive dual n-back task or an active control task']","['activity in areas of the default-mode (DMN), salience (SN), sensory-motor (SMN), frontoparietal (FPN), and subcortical (SCN) networks', 'aberrant functional brain activity', 'brain activity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0865424', 'cui_str': 'Adult attention deficit hyperactivity disorder'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}]",44.0,0.0412269,"Training effects were mainly observed as decreased brain activity during the trained task and increased activity during the untrained task, suggesting different neural mechanisms for trained and transfer tasks.","[{'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Salmi', 'Affiliation': 'Department of Neuroscience and Biomedical Engineering, Aalto University, Espoo, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Soveri', 'Affiliation': 'Department of Clinical Medicine, University of Turku, Turku, Finland.'}, {'ForeName': 'Viljami', 'Initials': 'V', 'LastName': 'Salmela', 'Affiliation': 'Department of Psychology and Logopedics, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Alho', 'Affiliation': 'Department of Psychology and Logopedics, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Leppämäki', 'Affiliation': 'Department of Psychiatry, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Tani', 'Affiliation': 'Department of Psychiatry, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Anniina', 'Initials': 'A', 'LastName': 'Koski', 'Affiliation': 'Department of Psychiatry, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Susanne M', 'Initials': 'SM', 'LastName': 'Jaeggi', 'Affiliation': 'School of Education, University of California Irvine, Irvine, California, USA.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Department of Psychology, Åbo Akademi University, Turku, Finland.'}]",Human brain mapping,['10.1002/hbm.25164']
2612,27503325,Wireless Participant Incentives Using Reloadable Bank Cards to Increase Clinical Trial Retention With Abused Women Drinkers: A Natural Experiment.,"Retaining participants in longitudinal studies is a unique methodological challenge in many areas of investigation, and specifically for researchers aiming to identify effective interventions for women experiencing intimate partner violence (IPV). Individuals in abusive relationships are often transient and have logistical, confidentiality, and safety concerns that limit future contact. A natural experiment occurred during a large randomized clinical trial enrolling women in abusive relationships who were also heavy drinkers, which allowed for the comparison of two incentive methods to promote longitudinal retention: cash payment versus reloadable wireless bank cards. In all, 600 patients were enrolled in the overall trial, which aimed to incentivize participants using a reloadable bank card system to promote the completion of 11 weekly interactive voice response system (IVRS) phone surveys and 3-, 6-, and 12-month follow-up phone or in person interviews. The first 145 participants were paid with cash as a result of logistical delays in setting up the bank card system. At 12 weeks, participants receiving the bank card incentive completed significantly more IVRS phone surveys, odds ratio (OR) = 2.4, 95% confidence interval (CI) = [0.01, 1.69]. There were no significant differences between the two groups related to satisfaction or safety and/or privacy. The bank card system delivered lower administrative burden for tracking payments for study staff. Based on these and other results, our large medical research university is implementing reloadable bank card as the preferred method of participant incentive payments.",2019,There were no significant differences between the two groups related to satisfaction or safety and/or privacy.,"['145 participants were paid with cash as a result of logistical delays in setting up the bank card system', '600 patients were enrolled in the overall trial, which aimed to incentivize participants using a reloadable bank card system to promote the completion of 11 weekly', 'enrolling women in abusive relationships who were also heavy drinkers, which allowed for the comparison of two incentive methods to promote longitudinal retention: cash payment versus reloadable wireless bank cards', 'women experiencing intimate partner violence (IPV', 'Abused Women Drinkers']","['interactive voice response system (IVRS) phone surveys and 3-, 6-, and 12-month follow-up phone or in person interviews']","['satisfaction or safety and/or privacy', 'IVRS phone surveys']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0442598', 'cui_str': 'Bank'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0001969', 'cui_str': 'Alcohol intoxication'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0220808', 'cui_str': 'Compensation'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0242810', 'cui_str': 'Battered Woman'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0080048', 'cui_str': 'Privacy'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",600.0,0.0484107,There were no significant differences between the two groups related to satisfaction or safety and/or privacy.,"[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Rodgers', 'Affiliation': '1 University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Meisel', 'Affiliation': '1 University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Wiebe', 'Affiliation': '1 University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Crits-Christoph', 'Affiliation': '1 University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Karin V', 'Initials': 'KV', 'LastName': 'Rhodes', 'Affiliation': '3 Hofstra Northwell School of Medicine, East Garden City, NY, USA.'}]",Journal of interpersonal violence,['10.1177/0886260516662849']
2613,31056840,"Evaluation of the Safety, Tolerability, Pharmacokinetics, and Food Effect of Danirixin Hydrobromide Tablets in Japanese Healthy Elderly Participants.","Danirixin is a selective and reversible CXC chemokine receptor 2 antagonist that may be useful for the treatment of respiratory diseases such as chronic obstructive pulmonary disease. This study aimed to evaluate the safety, tolerability, and pharmacokinetics of danirixin after administration of single oral doses of 10, 50, and 100 mg danirixin hydrobromide (HBr) tablets in the fed state (high-fat meal) (part 1) and to evaluate the food effect (low-fat meal) on the pharmacokinetics of danirixin after administration of a single oral dose of 50 mg danirixin HBr tablets (part 2). A total of 34 Japanese healthy elderly male participants were enrolled; 18 participants were included in part 1, and 16 in part 2. The systemic exposure to danirixin (maximum blood concentration [C max  ] and area under the concentration-time curve [AUC 0-t  ]) increased in an approximately dose-proportional manner. The exposure to danirixin was lower in the fed state (low-fat meal) than in the fasted state (a 56% and 35% decrease in C max  and AUC 0-t  , respectively). This first study of danirixin in Japanese healthy elderly participants showed a favorable safety profile with no drug-related adverse events and no clinically significant concerns in clinical laboratory values, vital signs, ocular examination, or electrocardiograms.",2019,"The exposure to danirixin was lower in the fed state (low-fat meal) than in the fasted state (a 56% and 35% decrease in C max  and AUC 0-t  , respectively).","['Japanese healthy elderly participants', '34 Japanese healthy elderly male participants were enrolled; 18 participants were included in part\xa01, and 16 in part\xa02', 'Japanese Healthy Elderly Participants']","['danirixin', 'Danirixin Hydrobromide Tablets', 'Danirixin', 'danirixin hydrobromide (HBr) tablets']","['clinical laboratory values, vital signs, ocular examination, or electrocardiograms', 'Safety, Tolerability, Pharmacokinetics, and Food Effect', 'safety, tolerability, and pharmacokinetics of danirixin', 'systemic exposure to danirixin (maximum blood concentration [C max  ] and area under the concentration-time curve [AUC 0-t  ']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0686754', 'cui_str': 'Well male elder'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C4519256', 'cui_str': 'danirixin'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C4519256', 'cui_str': 'danirixin'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0427728', 'cui_str': 'Blood concentration, dipstick - finding'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",34.0,0.0540276,"The exposure to danirixin was lower in the fed state (low-fat meal) than in the fasted state (a 56% and 35% decrease in C max  and AUC 0-t  , respectively).","[{'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Iida', 'Affiliation': 'Clinical Pharmacology Office, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Matsuzawa', 'Affiliation': 'Clinical Pharmacology Office, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Ogura', 'Affiliation': 'Clinical Pharmacology Office, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nagakubo', 'Affiliation': 'Biomedical Data Sciences Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Wakamatsu', 'Affiliation': 'Pre-Clinical Development Department, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Ambery', 'Affiliation': 'Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Stockley Park, UK.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Miller', 'Affiliation': 'Respiratory Therapy Area Unit, GlaxoSmithKline Research and Development, Collegeville, PA, USA.'}, {'ForeName': 'Aili L', 'Initials': 'AL', 'LastName': 'Lazaar', 'Affiliation': 'Respiratory Therapy Area Unit, GlaxoSmithKline Research and Development, Collegeville, PA, USA.'}, {'ForeName': 'Yotaro', 'Initials': 'Y', 'LastName': 'Numachi', 'Affiliation': 'Medicines Development, Japan Development Division, GlaxoSmithKline KK, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.693']
2614,32816313,The effects of the Newborn Behavioral Observations (NBO) system in early intervention: A multisite randomized controlled trial.,"The purpose of this pilot study was to evaluate the effect of an infant mental health intervention, the Newborn Behavioral Observations system (NBO), versus usual care (UC) on infant neurodevelopment and maternal depressive symptoms in early intervention (EI). This multisite randomized trial enrolled newborns into the NBO (n = 16) or UC group (n = 22) and followed them for 6 months. Outcome measures included the Battelle Developmental Inventory (BDI-2), Bayley Scales of Infants Development (BSID-III), and Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D and BSID-III were collected at 3- and 6-months post EI entry and the BDI-2 was collected at EI entry and 6-months post-EI entry. We estimated group differences [95% CI], adjusting for program characteristics. At 6 months, the NBO group had greater gains in Communication (b = 1.0 [0.2, 1.8]), Self-Care (b = 2.0 [0.1, 3.9]), Perception and Concepts (b = 2.0 [0.4, 3.6]), and Attention and Memory (b = 3.0 [0.4, 6.0]) than the UC group. The NBO group also had greater decline in maternal postnatal depressive symptoms (b = -2.0 [-3.7, -0.3]) than the UC group. Infants receiving the NBO infant mental health intervention had greater gains in cognitive and adaptive functions at 6 months than infants receiving UC. Caregivers receiving NBO care had greater improvements in maternal depressive symptoms than caregivers receiving UC.",2020,"At 6 months, the NBO group had greater gains in Communication (b = 1.0 [0.2, 1.8]), Self-Care (b = 2.0 [0.1, 3.9]), Perception and Concepts (b = 2.0 [0.4, 3.6]), and Attention and Memory (","['infant neurodevelopment and maternal depressive symptoms in early intervention (EI', 'newborns into the NBO (n\xa0=\xa016) or UC group (n\xa0=\xa022) and followed them for 6 months', 'early intervention', 'Infants receiving the NBO infant mental health intervention']","['infant mental health intervention, the Newborn Behavioral Observations system (NBO), versus usual care (UC', 'NBO', 'Newborn Behavioral Observations (NBO) system']","['cognitive and adaptive functions', 'CES-D and BSID-III', 'maternal postnatal depressive symptoms', 'gains in Communication', 'Battelle Developmental Inventory (BDI-2), Bayley Scales of Infants Development (BSID-III), and Center for Epidemiologic Studies Depression Scale (CES-D', 'Self-Care', 'maternal depressive symptoms']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0558039', 'cui_str': 'Observation of behavior'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0558039', 'cui_str': 'Observation of behavior'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002783', 'cui_str': 'Studies, Epidemiologic'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0451021', 'cui_str': 'Bayley scale of infant development'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}]",,0.0429025,"At 6 months, the NBO group had greater gains in Communication (b = 1.0 [0.2, 1.8]), Self-Care (b = 2.0 [0.1, 3.9]), Perception and Concepts (b = 2.0 [0.4, 3.6]), and Attention and Memory (","[{'ForeName': 'Beth M', 'Initials': 'BM', 'LastName': 'McManus', 'Affiliation': 'Department of Health Systems, Management and Policy, Colorado School of Public Health, Aurora, Colorado.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Blanchard', 'Affiliation': 'Department of Physical Therapy and Human Movement Science, Sacred Heart University, Fairfield, Connecticut.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Murphy', 'Affiliation': 'Physical Therapy Program, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'J Kevin', 'Initials': 'JK', 'LastName': 'Nugent', 'Affiliation': ""Division of Developmental Medicine, Boston Children's Hospital and Harvard Medical School, Boston, Massachusetts.""}]",Infant mental health journal,['10.1002/imhj.21882']
2615,32816318,The effect of plasma melatonin levels in the treatment of lifelong premature ejaculation with selective serotonin reuptake inhibitors.,"The aim of our study was to compare melatonin levels of patients with lifelong premature ejaculation (LPE) (n:60) with healthy controls (n:30) and to investigate the changes of melatonin levels in the treatment with dapoxetine and sertraline. Age, body mass index, duration of marriage, weekly intercourse number, International Index of Erectile Function scores, Intravaginal Ejaculation Latency Time (IELT) and melatonin levels were recorded. LPE patients were divided into two treatment groups. The first group was included 30 patients, who received 60 mg dapoxetine for six weeks, twice a week, an hour before intercourse. The second group received 50 mg of sertraline daily, for six weeks. IELT and melatonin measures were repeated after the treatment. IELT (dapoxetine group: 41.22 ± 21.3 s, sertraline group: 48 ± 23.11 s, control group: 195.54 ± 84.14 s; p < .001) and melatonin levels (dapoxetine group: 5.75 ± 2.04 pg/mL, sertraline group: 5.49 ± 2.88 pg/mL, control group: 13.4 ± 12.09 pg/mL; p < .001) of both LPE groups were significantly lower than control group. Following the six-week sertraline (before: 48 ± 23.11 s, after: 101.01 ± 59.55 s; p < .001) and dapoxetine (before: 41.22 ± 21.3 s, after: 97.39 ± 44.1 s; p < .001) treatments, IELT increased. The melatonin levels increased in the sertraline group (before: 5.49 ± 2.88 pg/mL, after: 10.6 ± 7.37 pg/mL; p < .001). Our results indicate that melatonin levels of LPE patients are lower than levels of healthy volunteers. Furthermore, we found a significant increase in melatonin levels following sertraline treatment.",2020,"The melatonin levels increased in the sertraline group (before: 5.49 ± 2.88 pg/mL, after: 10.6 ± 7.37 pg/mL; p < .001).","['patients with lifelong premature ejaculation (LPE) (n:60) with healthy controls (n:30', 'lifelong premature ejaculation with selective serotonin reuptake inhibitors', 'healthy volunteers', 'LPE patients']","['60\xa0mg dapoxetine', 'melatonin levels (dapoxetine group: 5.75\xa0±\xa02.04\xa0pg/mL, sertraline', 'sertraline', 'dapoxetine and sertraline', '50\xa0mg of sertraline', 'plasma melatonin levels', 'LPE', 'IELT (dapoxetine']","['dapoxetine', 'melatonin levels', 'IELT and melatonin measures', 'Age, body mass index, duration of marriage, weekly intercourse number, International Index of Erectile Function scores, Intravaginal Ejaculation Latency Time (IELT) and melatonin levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0215087', 'cui_str': 'dapoxetine'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C0033038', 'cui_str': 'Premature ejaculation'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0215087', 'cui_str': 'dapoxetine'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2959364', 'cui_str': 'International index of erectile function score'}]",,0.0703747,"The melatonin levels increased in the sertraline group (before: 5.49 ± 2.88 pg/mL, after: 10.6 ± 7.37 pg/mL; p < .001).","[{'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Kalkanli', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Cem Tugrul', 'Initials': 'CT', 'LastName': 'Gezmis', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Fikri', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Nusret Can', 'Initials': 'NC', 'LastName': 'Cilesiz', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Ozkan', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Eroglu', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Memduh', 'Initials': 'M', 'LastName': 'Aydin', 'Affiliation': 'Department of Urology, Taksim Education and Research Hospital, Istanbul, Turkey.'}]",Andrologia,['10.1111/and.13785']
2616,32816320,Primaquine alternative dosing schedules for preventing malaria relapse in people with Plasmodium vivax.,"BACKGROUND


Plasmodium vivax liver stages (hypnozoites) may cause relapses, prolonging morbidity, and impeding malaria control and elimination. The World Health Organization (WHO) recommends three schedules for primaquine: 0.25 mg/kg/day (standard), or 0.5 mg/kg/day (high standard) for 14 days, or 0.75 mg/kg once weekly for eight weeks, all of which can be difficult to complete. Since primaquine can cause haemolysis in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency, clinicians may be reluctant to prescribe primaquine without G6PD testing, and recommendations when G6PD status is unknown must be based on an assessment of the risks and benefits of prescribing primaquine. Alternative safe and efficacious regimens are needed.
OBJECTIVES


To assess the efficacy and safety of alternative primaquine regimens for radical cure of P vivax malaria compared to the standard or high-standard 14-day courses.
SEARCH METHODS


We searched the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (PubMed); Embase (Ovid); LILACS (BIREME); WHO International Clinical Trials Registry Platform and ClinicalTrials.gov up to 2 September 2019, and checked the reference lists of all identified studies.
SELECTION CRITERIA


Randomized controlled trials (RCTs) of adults and children with P vivax malaria using either chloroquine or artemisinin-based combination therapy plus primaquine at a total adult dose of at least 210 mg, compared with the WHO-recommended regimens of 0.25 or 0.5 mg/kg/day for 14 days.
DATA COLLECTION AND ANALYSIS


Two review authors independently assessed trial eligibility and quality, and extracted data. We calculated risk ratios (RRs) with 95% confidence intervals (CIs) for dichotomous data. We grouped efficacy data according to length of follow-up, partner drug, and trial location. We analysed safety data where included.
MAIN RESULTS


0.5 mg/kg/day for seven days versus standard 0.25 mg/kg/day for 14 days There may be little or no difference in P vivax recurrences at six to seven months when using the same total dose (210 mg adult dose) over seven days compared to 14 days (RR 0.96, 95% CI 0.66 to 1.39; 4 RCTs, 1211 participants; low-certainty evidence). No serious adverse events were reported. We do not know if there is any difference in the number of adverse events resulting in discontinuation of primaquine (RR 1.04, 95% CI 0.15 to 7.38; 5 RCTs, 1427 participants) or in the frequency of anaemia (RR 3.00, 95% CI 0.12 to 72.91, 1 RCT, 240 participants) between the shorter and longer regimens (very low-certainty evidence). Three trials excluded people with G6PD deficiency; two did not provide this information. Pregnant and lactating women were either excluded or no details were provided. High-standard 0.5 mg/kg/day for 14 days versus standard 0.25 mg/kg/day for 14 days There may be little or no difference in P vivax recurrences at six months with 0.5 mg/kg/day primaquine for 14 days compared to 0.25 mg/kg/day for 14 days (RR 0.84 (95% CI 0.49 to 1.43; 2 RCTs, 677 participants, low-certainty evidence). No serious adverse events were reported. We do not know whether there is a difference in adverse events resulting in discontinuation of treatment with the high-standard dosage (RR 4.19, 95% CI 0.90 to 19.60; 1 RCT, 778 participants, very low-certainty evidence). People with G6PD deficiency and pregnant or lactating women were excluded. 0.75 mg/kg/week for eight weeks versus high-standard 0.5 mg/kg/day for 14 days We do not know whether weekly primaquine increases or decreases recurrences of P vivax compared to high-standard 0.5 mg/kg/day for 14 days, at 11 months' follow-up (RR 3.18, 95% CI 0.37 to 27.60; 1 RCT, 122 participants; very low-certainty evidence). No serious adverse events and no episodes of anaemia were reported. G6PD-deficient patients were not randomized but included in the weekly primaquine group (only one patient detected). 1 mg/kg/day for seven days versus high standard 0.5 mg/kg/day for 14 days There is probably little or no difference in P vivax recurrences at 12 months between 1.0 mg/kg/day primaquine for seven days and the high-standard 0.5 mg/kg/day for 14 days (RR 1.03, 95% CI 0.82 to 1.30; 2 RCTs, 2526 participants; moderate-certainty evidence). There may be moderate to large increase in serious adverse events in the 1.0 mg/kg/day primaquine for seven days compared with the high-standard 0.5 mg/kg/day for 14 days, during 42 days follow-up (RR 12.03, 95% CI 1.57 to 92.30; 1 RCT, 1872 participants, low-certainty evidence). We do not know if there is a difference between 1.0 mg/kg/day primaquine for seven days and high-standard 0.5 mg/kg/day for 14 days in adverse events that resulted in discontinuation of treatment (RR 2.50, 95% CI 0.49 to 12.87; 1 RCT, 2526 participants, very low-certainty evidence), nor if there is difference in frequency of anaemia by 42 days (RR 0.93, 95% CI 0.62 to 1.41; 2 RCTs, 2440 participants, very low-certainty evidence). People with G6PD deficiency were excluded. Other regimens Two RCTs evaluated other rarely-used doses of primaquine, one of which had very high loss to follow-up. Adverse events were not reported. People with G6PD deficiency and pregnant or lactating women were excluded.
AUTHORS' CONCLUSIONS


Trials available to date do not detect a difference in recurrence between the following regimens: 1) 0.5 mg/kg/day for seven days versus standard 0.25 mg/kg/day for 14 days; 2) high-standard 0.5 mg/kg/day for 14 days versus standard 0.25 mg/kg/day for 14 days; 3) 0.75 mg/kg/week for eight weeks versus high-standard 0.5 mg/kg/day for 14 days; 4) 1 mg/kg/day for seven days versus high-standard 0.5 mg/kg/day for 14 days. There were no differences detected in adverse events for Comparisons 1, 2 or 3, but there may be more serious adverse events with the high seven-day course in Comparison 4. The shorter regimen of 0.5 mg/kg/day for seven days versus standard 0.25 mg/kg/day for 14 days may suit G6PD-normal patients. Further research will help increase the certainty of the findings and applicability in different settings.",2020,"We do not know whether there is a difference in adverse events resulting in discontinuation of treatment with the high-standard dosage (RR 4.19, 95% CI 0.90 to 19.60; 1 RCT, 778 participants, very low-certainty evidence).","['G6PD-deficient patients', 'Pregnant and lactating women', 'individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency', 'People with G6PD deficiency were excluded', 'People with G6PD deficiency and pregnant or lactating women were excluded', 'adults and children with P vivax malaria using either', 'People with G6PD deficiency and pregnant or lactating women', 'people with Plasmodium vivax']","['primaquine', 'Primaquine', 'chloroquine or artemisinin-based combination therapy plus primaquine']","['malaria relapse', 'P vivax recurrences', 'recurrences of P vivax', 'radical cure of P vivax malaria', 'Adverse events', 'efficacy and safety', 'serious adverse events', 'serious adverse events and no episodes of anaemia', 'adverse events', 'frequency of anaemia', 'calculated risk ratios (RRs']","[{'cui': 'C0017757', 'cui_str': 'Glucose-6-phosphate dehydrogenase'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2939465', 'cui_str': 'Deficiency of glucose-6-phosphate dehydrogenase'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0858321', 'cui_str': 'Plasmodium vivax infection'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0032154', 'cui_str': 'Plasmodium vivax'}]","[{'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0746365', 'cui_str': 'Malaria relapse'}, {'cui': 'C0858321', 'cui_str': 'Plasmodium vivax infection'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",2526.0,0.184528,"We do not know whether there is a difference in adverse events resulting in discontinuation of treatment with the high-standard dosage (RR 4.19, 95% CI 0.90 to 19.60; 1 RCT, 778 participants, very low-certainty evidence).","[{'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Milligan', 'Affiliation': 'Cochrane Infectious Diseases Group, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Daher', 'Affiliation': 'Vice-Presidency of Research and Biological Collections, Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Brazil.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Villanueva', 'Affiliation': 'Cochrane Response, Cochrane, London, UK.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Bergman', 'Affiliation': 'Cochrane Response, Cochrane, London, UK.'}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Graves', 'Affiliation': 'College of Public Health, Medical and Veterinary Sciences, James Cook University, Cairns, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012656.pub3']
2617,32813610,Children's Oncology Group AALL0434: A Phase III Randomized Clinical Trial Testing Nelarabine in Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia.,"PURPOSE


Nelarabine is effective in inducing remission in patients with relapsed and refractory T-cell acute lymphoblastic leukemia (T-ALL) but has not been fully evaluated in those with newly diagnosed disease.
PATIENTS AND METHODS


From 2007 to 2014, Children's Oncology Group trial AALL0434 (ClinicalTrials.gov identifier: NCT00408005) enrolled 1,562 evaluable patients with T-ALL age 1-31 years who received the augmented Berlin-Frankfurt-Muenster (ABFM) regimen with a 2 × 2 pseudo-factorial randomization to receive escalating-dose methotrexate (MTX) without leucovorin rescue plus pegaspargase (C-MTX) or high-dose MTX (HDMTX) with leucovorin rescue. Intermediate- and high-risk patients were also randomly assigned after induction to receive or not receive six 5-day courses of nelarabine that was incorporated into ABFM. Patients who experienced induction failure were nonrandomly assigned to HDMTX plus nelarabine. Patients with overt CNS disease (CNS3; ≥ 5 WBCs/μL with blasts) received HDMTX and were randomly assigned to receive or not receive nelarabine. All patients, except those with low-risk disease, received cranial irradiation.
RESULTS


The 5-year event-free and overall survival rates were 83.7% ± 1.1% and 89.5% ± 0.9%, respectively. The 5-year disease-free survival (DFS) rates for patients with T-ALL randomly assigned to nelarabine (n = 323) and no nelarabine (n = 336) were 88.2% ± 2.4% and 82.1% ± 2.7%, respectively ( P  = .029). Differences between DFS in a four-arm comparison were significant ( P  = .01), with no interactions between the MTX and nelarabine randomizations ( P  = .41). Patients treated with the best-performing arm, C-MTX plus nelarabine, had a 5-year DFS of 91% (n = 147). Patients who received nelarabine had significantly fewer isolated and combined CNS relapses compared with patients who did not receive nelarabine (1.3% ± 0.63%  v  6.9% ± 1.4%, respectively;  P  = .0001). Toxicities, including neurotoxicity, were acceptable and similar between all four arms.
CONCLUSION


The addition of nelarabine to ABFM therapy improved DFS for children and young adults with newly diagnosed T-ALL without increased toxicity.",2020,"Patients who received nelarabine had significantly fewer isolated and combined CNS relapses compared with patients who did not receive nelarabine (1.3% ± 0.63%  v  6.9% ± 1.4%, respectively;  P  = .0001).","['Patients who experienced induction failure', '1,562 evaluable patients with T-ALL age 1-31 years who received the augmented Berlin-Frankfurt-Muenster (ABFM) regimen with a 2 × 2 pseudo-factorial randomization to receive', 'Intermediate- and high-risk patients', 'patients with relapsed and refractory T-cell acute lymphoblastic leukemia (T-ALL', 'Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia', 'Patients with overt CNS disease (CNS3; ≥ 5 WBCs/μL with blasts) received']","['nelarabine to ABFM therapy', 'escalating-dose methotrexate (MTX) without leucovorin rescue plus pegaspargase (C-MTX) or high-dose MTX (HDMTX) with leucovorin rescue', 'Nelarabine', 'nelarabine', 'HDMTX', 'HDMTX plus nelarabine']","['DFS', '5-year event-free and overall survival rates', 'Toxicities, including neurotoxicity', 'toxicity', 'CNS relapses', '5-year disease-free survival (DFS) rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1961099', 'cui_str': 'T-cell acute lymphoblastic leukemia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205237', 'cui_str': 'False'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007682', 'cui_str': 'Disorder of the central nervous system'}, {'cui': 'C0337026', 'cui_str': 'Blast'}]","[{'cui': 'C0907349', 'cui_str': 'nelarabine'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005125', 'cui_str': 'Berlin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0071568', 'cui_str': 'pegaspargase'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",336.0,0.122522,"Patients who received nelarabine had significantly fewer isolated and combined CNS relapses compared with patients who did not receive nelarabine (1.3% ± 0.63%  v  6.9% ± 1.4%, respectively;  P  = .0001).","[{'ForeName': 'Kimberly P', 'Initials': 'KP', 'LastName': 'Dunsmore', 'Affiliation': 'Virginia Tech Carilion School of Medicine and Carilion Clinic, Roanoke, VA.'}, {'ForeName': 'Stuart S', 'Initials': 'SS', 'LastName': 'Winter', 'Affiliation': ""Children's Minnesota Cancer and Blood Disorders Program, Minneapolis, MN.""}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Brent L', 'Initials': 'BL', 'LastName': 'Wood', 'Affiliation': ""Laboratory Medicine, Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Natia', 'Initials': 'N', 'LastName': 'Esiashvili', 'Affiliation': 'Department of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Zhiguo', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics, Colleges of Medicine and Public Health and Health Professions, University of Florida, Gainesville, FL.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Eisenberg', 'Affiliation': 'Pediatric Hematology/Oncology, University of New Mexico Health Sciences Center, Albuquerque, NM.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Briegel', 'Affiliation': ""Pharmacy Department, Perth Children's Hospital, Nedlands, Western Australia, Australia.""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hayashi', 'Affiliation': ""Pediatric Hematology/Oncology, Washington School of Medicine, St Louis Children's Hospital, St Louis, MO.""}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Gastier-Foster', 'Affiliation': ""Nationwide Children's Hospital, Columbus OH.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Carroll', 'Affiliation': 'Department of Genetics, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Nyla A', 'Initials': 'NA', 'LastName': 'Heerema', 'Affiliation': 'Department of Pathology, The Ohio State University, Columbus, OH.'}, {'ForeName': 'Barbara L', 'Initials': 'BL', 'LastName': 'Asselin', 'Affiliation': 'Department of Pediatrics, University of Rochester Medical Center and Wilmot Cancer Institute, Rochester, NY.'}, {'ForeName': 'Karen R', 'Initials': 'KR', 'LastName': 'Rabin', 'Affiliation': 'Pediatric Hematology/Oncology, Baylor College of Medicine/Dan L. Duncan Comprehensive Cancer Center, Houston TX.'}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Zweidler-Mckay', 'Affiliation': 'ImmunoGen, Waltham, MA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Raetz', 'Affiliation': 'Laura and Isaac Perlmutter Cancer Center at New York University Langone Health, New York, NY.'}, {'ForeName': 'Mignon L', 'Initials': 'ML', 'LastName': 'Loh', 'Affiliation': ""Department of Pediatrics, University of California, San Francisco Benioff Children's Hospital and the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco, CA.""}, {'ForeName': 'Kirk R', 'Initials': 'KR', 'LastName': 'Schultz', 'Affiliation': ""Pediatric Hematology-Oncology, British Columbia Children's Hospital, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Naomi J', 'Initials': 'NJ', 'LastName': 'Winick', 'Affiliation': 'Pediatric Hematology/Oncology, University of Texas Southwestern/Simmons Cancer Center, Dallas, TX.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Laura and Isaac Perlmutter Cancer Center at New York University Langone Health, New York, NY.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Department of Pediatrics and The Center for Childhood Cancer Research, The Children's Hospital of Philadelphia and The Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00256']
2618,32813887,Exploring novel systemic biomarker approaches in grass-pollen sublingual immunotherapy using omics.,"BACKGROUND


Sublingual allergen-specific immunotherapy (SLIT) intervention improves the control of grass pollen allergy by maintaining allergen tolerance after cessation. Despite its widespread use, little is known about systemic effects and kinetics associated to SLIT, as well as the influence of the patient sensitization phenotype (Mono- or Poli-sensitized). In this quest, omics sciences could help to gain new insights to understand SLIT effects.
METHODS


47 grass-pollen-allergic patients were enrolled in a double-blind, placebo-controlled, multicenter trial using GRAZAX® during 2 years. Immunological assays (sIgE, sIgG4 and ISAC) were carried out to 31 patients who finished the trial. Additionally, serum and PBMCs samples were analyzed by metabolomics and transcriptomics, respectively. Based on their sensitization level, 22 patients were allocated in Mono or Poli-sensitized groups, excluding patients allergic to epithelia. Individuals were compared based on their treatment (Active/Placebo) and sensitization level (Mono/Poli).
RESULTS


Kinetics of serological changes agreed with those previously described. At two years of SLIT, there are scarce systemic changes that could be associated to improvement in systemic inflammation. Poli-sensitized patients presented a higher inflammation at inclusion, while Mono-sensitized patients presented a reduced activity of mast cells and phagocytes as an effect of the treatment.
CONCLUSIONS


The most relevant systemic change detected after two years of SLIT was the desensitization of effector cells, which was only detected in Mono-sensitized patients. This change may be related to the clinical improvement, as previously reported, and, together with the other results, may explain why clinical effect is lost if SLIT is discontinued at this point.",2020,"Poli-sensitized patients presented a higher inflammation at inclusion, while Mono-sensitized patients presented a reduced activity of mast cells and phagocytes as an effect of the treatment.
","['31 patients who finished the trial', '47 grass-pollen-allergic patients', '22 patients were allocated in Mono or Poli-sensitized groups, excluding patients allergic to epithelia']","['Placebo) and sensitization level (Mono/Poli', 'GRAZAX®', 'Sublingual allergen-specific immunotherapy (SLIT) intervention', 'placebo']","['sIgE, sIgG4 and ISAC', 'serum and PBMCs samples', 'systemic inflammation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0440307', 'cui_str': 'grass pollen'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0032400', 'cui_str': 'Poly(rA)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021345', 'cui_str': 'Infectious mononucleosis'}, {'cui': 'C0032400', 'cui_str': 'Poly(rA)'}, {'cui': 'C2935532', 'cui_str': 'Grazax'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",22.0,0.327353,"Poli-sensitized patients presented a higher inflammation at inclusion, while Mono-sensitized patients presented a reduced activity of mast cells and phagocytes as an effect of the treatment.
","[{'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Barker-Tejeda', 'Affiliation': 'Centro de Metabolómica y Bioanálisis (CEMBIO), Facultad de Farmacia, Universidad San Pablo-CEU, CEU Universities, Urbanización Montepríncipe, Boadilla del Monte 28660. , Madrid, España.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bazire', 'Affiliation': 'Servicio de Alergia, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IP), Madrid, España.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Obeso', 'Affiliation': 'Centro de Metabolómica y Bioanálisis (CEMBIO), Facultad de Farmacia, Universidad San Pablo-CEU, CEU Universities, Urbanización Montepríncipe, Boadilla del Monte 28660. , Madrid, España.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mera-Berriatua', 'Affiliation': 'Instituto de Medicina Molecular Aplicada (IMMA), Departamento de Ciencias Médicas Básicas. Facultad de Medicina, Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Rosace', 'Affiliation': 'Instituto de Medicina Molecular Aplicada (IMMA), Departamento de Ciencias Médicas Básicas. Facultad de Medicina, Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vazquez-Cortes', 'Affiliation': 'Servicio de Alergia, Hospital Clínico San Carlos, Universidad Complutense, IdISSC, Madrid, España.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ramos', 'Affiliation': 'Servicio de Alergia, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IP), Madrid, España.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rico', 'Affiliation': 'Instituto de Medicina Molecular Aplicada (IMMA), Departamento de Ciencias Médicas Básicas. Facultad de Medicina, Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chivato', 'Affiliation': 'Instituto de Medicina Molecular Aplicada (IMMA), Departamento de Ciencias Médicas Básicas. Facultad de Medicina, Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Barbas', 'Affiliation': 'Centro de Metabolómica y Bioanálisis (CEMBIO), Facultad de Farmacia, Universidad San Pablo-CEU, CEU Universities, Urbanización Montepríncipe, Boadilla del Monte 28660. , Madrid, España.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Villaseñor', 'Affiliation': 'Centro de Metabolómica y Bioanálisis (CEMBIO), Facultad de Farmacia, Universidad San Pablo-CEU, CEU Universities, Urbanización Montepríncipe, Boadilla del Monte 28660. , Madrid, España.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Escribese', 'Affiliation': 'Instituto de Medicina Molecular Aplicada (IMMA), Departamento de Ciencias Médicas Básicas. Facultad de Medicina, Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fernández-Rivas', 'Affiliation': 'Servicio de Alergia, Hospital Clínico San Carlos, Universidad Complutense, IdISSC, Madrid, España.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Blanco', 'Affiliation': 'Servicio de Alergia, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IP), Madrid, España.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Barber', 'Affiliation': 'Instituto de Medicina Molecular Aplicada (IMMA), Departamento de Ciencias Médicas Básicas. Facultad de Medicina, Universidad San Pablo-CEU, CEU Universities, Madrid, España.'}]",Allergy,['10.1111/all.14565']
2619,32813915,Predictive variables for poor long-term physical recovery after intensive care unit stay: An exploratory study.,"BACKGROUND


Elucidating factors that influence physical recovery of survivors after an intensive care unit (ICU) stay is paramount to maximising long-term functional outcomes. We examined potential predictors for poor long-term physical recovery in ICU survivors.
METHODS


Based on secondary analysis of a trial of 50 ICU patients who underwent mobilisation in the ICU and were followed for one year, linear regression analysis examined the associations of exposure variables (baseline characteristics, severity of illness variables, ICU-related variables, and lengths of ICU and hospital stay), with physical recovery variables (muscle strength, exercise capacity, and self-reported physical function), measured one year after ICU discharge.
RESULTS


When the data were adjusted for age, female gender was associated with reduced muscle strength (p=0.003), exercise capacity (p<0.0001) and self-reported physical function (p=0.01). Older age, when adjusted for gender, was associated with reduced exercise capacity (p<0.001). After adjusting for gender and age, an association was observed between a lower score on one or two physical recovery variables and exposure variables, specifically, high body mass index, low functional independence, comorbidity and low self-reported physical function at baseline, muscle weakness at ICU discharge, and longer hospital stay. No adjustment was made for cumulative type I error rate due to small number of participants.
CONCLUSION


Elucidating risk factors for poor long-term physical recovery after ICU stay, including gender, may be critical if mobilisation and exercise are to be prescribed expediently during and after ICU stay, to ensure maximal long-term recovery.
EDITORIAL COMMENT


A patient's pre-critical illness general condition may be very important as far as how, for those who survive their critical illness episode, recover function. In this small but well controlled study in 50 ICU survivors, the predictors for poor physical recovery (after adjusting for age and gender) were high BMI, low functional independence, comorbidity, and low physical function at baseline.",2020,", female gender was associated with reduced muscle strength (p=0.003), exercise capacity (p<0.0001) and self-reported physical function (p=0.01).","['50 ICU survivors', '50 ICU patients who underwent mobilisation in the ICU']",[],"['severity of illness variables, ICU-related variables, and lengths of ICU and hospital stay), with physical recovery variables (muscle strength, exercise capacity, and self-reported physical function', 'reduced muscle strength', 'cumulative type', 'exercise capacity (p<0.0001) and self-reported physical function', 'high body mass index, low functional independence, comorbidity and low self-reported physical function at baseline, muscle weakness at ICU discharge, and longer hospital stay']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}]",[],"[{'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030552', 'cui_str': 'Paresis'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0205166', 'cui_str': 'Long'}]",50.0,0.0304017,", female gender was associated with reduced muscle strength (p=0.003), exercise capacity (p<0.0001) and self-reported physical function (p=0.01).","[{'ForeName': 'Ólöf R', 'Initials': 'ÓR', 'LastName': 'Ámundadóttir', 'Affiliation': 'Department of Physiotherapy, Landspitali - The National University Hospital of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Rannveig J', 'Initials': 'RJ', 'LastName': 'Jónasdóttir', 'Affiliation': 'Faculty of Nursing, School of Health Sciences, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Kristinn', 'Initials': 'K', 'LastName': 'Sigvaldason', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Landspitali - The National University Hospital of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Jónsdóttir', 'Affiliation': 'Faculty of Nursing, School of Health Sciences, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Alma D', 'Initials': 'AD', 'LastName': 'Möller', 'Affiliation': 'Directorate of Health, Reykjavik, Iceland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Dean', 'Affiliation': 'Faculty of Medicine, School of Health Sciences, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Thorarinn', 'Initials': 'T', 'LastName': 'Sveinsson', 'Affiliation': 'Faculty of Medicine, School of Health Sciences, University of Iceland, Reykjavik, Iceland.'}, {'ForeName': 'Gísli H', 'Initials': 'GH', 'LastName': 'Sigurðsson', 'Affiliation': 'Faculty of Medicine, School of Health Sciences, University of Iceland, Reykjavik, Iceland.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13690']
2620,32813928,Can abdominal hypropressive technique improve stress urinary inconsistence? an assessor-blinded randomized controlled trial.,"AIM


To verify which one improves better stress urinary incontinence (SUI) symptoms: abdominal hypopressive technique (AHT) or pelvic floor muscle training (PFMT).
METHODS


Randomized controlled trial. Women with SUI who had not participated of physiotherapy program before were invited. The outcome measures were 7-day bladder diary, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and pelvic floor muscles (PFM) function measured by Modified Oxford grading System with vaginal palpation and manometry with Peritron. Intervention consisted by 12 weeks of exercises program including PFMT or AHT program, in groups of maximum three women, twice a week, with physiotherapist supervision.
RESULTS


AHT and PFMT groups reduced urinary leakage episodes in 7 days, -0.64 and -1.91, respectively, but PFMT was superior, whit mean difference -1.27 (95% confidence interval [CI]: -1.92 to -0,62) and effect size was 0.94 in favor to PFMT. Regarding to total score of ICIQ-SF, both groups improved, with mean difference between groups -4.7 (95% CI: -6.90 to -2.50) and effect size was 1.04 in favor to PFMT. Manometry also presented improvement after treatment for both groups with mean difference between them of 11 (95% CI: 6.33-15.67) and effect size was 1.15 also in favor to PFMT.
CONCLUSION


Regarding to SUI symptoms, quality of life impact and PFM function both groups presented improvement, however, PFMT was superior to AHT among all of them.",2020,"Regarding to SUI symptoms, quality of life impact and PFM function both groups presented improvement, however, PFMT was superior to AHT among all of them.",['Women with SUI who had not participated of physiotherapy program before were invited'],"['PFMT', 'exercises program including PFMT or AHT program', 'hypopressive technique (AHT) or pelvic floor muscle training (PFMT']","['urinary leakage episodes', '7-day bladder diary, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and pelvic floor muscles (PFM) function measured by Modified Oxford grading System with vaginal palpation and manometry with Peritron', 'SUI symptoms, quality of life impact and PFM function']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0015376', 'cui_str': 'Extravasation'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart'}, {'cui': 'C2711460', 'cui_str': 'International consultation on incontinence questionnaire'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1273712', 'cui_str': 'Grading system used'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0030247', 'cui_str': 'Palpation'}, {'cui': 'C0024751', 'cui_str': 'Manometry'}, {'cui': 'C0042025', 'cui_str': 'Genuine stress incontinence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0231484', 'cui_str': 'Muscle function'}]",,0.168795,"Regarding to SUI symptoms, quality of life impact and PFM function both groups presented improvement, however, PFMT was superior to AHT among all of them.","[{'ForeName': 'Luciene A', 'Initials': 'LA', 'LastName': 'Jose-Vaz', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Carine L', 'Initials': 'CL', 'LastName': 'Andrade', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Cardoso', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Bruno T', 'Initials': 'BT', 'LastName': 'Bernardes', 'Affiliation': 'Gynecology and Obstetrics Department, Urogynaecology Ambulatory Unit, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Vanessa S', 'Initials': 'VS', 'LastName': 'Pereira-Baldon', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}, {'ForeName': 'Ana Paula M', 'Initials': 'APM', 'LastName': 'Resende', 'Affiliation': 'Physiotherapy Department, Federal University of Uberlândia, Minas Gerais, Brazil.'}]",Neurourology and urodynamics,['10.1002/nau.24489']
2621,32818346,Impact of dexamethasone intraocular suspension 9% on intraocular pressure following routine cataract surgery: post hoc analysis.,"PURPOSE


To characterize intraocular pressure (IOP) response following treatment with dexamethasone intraocular suspension 9%) vs placebo (vehicle) injection or topical prednisolone acetate 1% and to identify factors correlating with increased intraocular pressure (IOP) following cataract surgery.
SETTING


Data were pooled from two phase 3 clinical trials of patients undergoing routine cataract surgery.
DESIGN


Randomized double-blind study and open-label study.
METHODS


Subjects were randomized to treatment with dexamethasone intraocular suspension or placebo in the double-blind study 1, and dexamethasone intraocular suspension or topical prednisolone acetate in the open-label study 2. Subjects who experienced ≥10 mm Hg, 15 mm Hg, or 20 mm Hg postoperative IOP increase from baseline were stratified by baseline IOP. Univariate and multivariate logistic regression models of patient variables were applied to identify independent risk factors predictive of IOP elevation ≥10 mm Hg or 15 mm Hg.
RESULTS


The study comprised 414 subjects. Dexamethasone intraocular suspension was associated with a slightly higher mean IOP at the first postoperative visit vs prednisolone (P<0.05); however, mean IOP was not statistically different between the 2 groups by postoperative day 8 (P=0.5006) or thereafter. Univariate analysis showed that both prednisolone and dexamethasone intraocular suspension increased risk of postoperative IOP elevation compared with placebo; however, there was no statistically significant increased risk with dexamethasone intraocular suspension vs prednisolone. Aside from anti-inflammatory treatment, risk factors for postoperative IOP elevation by univariate and multivariate analyses were higher baseline IOP, high myopia, and, when defining IOP increase as ≥15 mm Hg from baseline, male sex.
CONCLUSIONS


Dexamethasone intraocular suspension was associated with IOP elevation patterns comparable to topical prednisolone. High myopia, higher baseline IOP, and male sex were significant predictors of postoperative IOP elevation in this cohort.",2020,"Dexamethasone intraocular suspension was associated with a slightly higher mean IOP at the first postoperative visit vs prednisolone (P<0.05); however, mean IOP was not statistically different between the 2 groups by postoperative day 8 (P=0.5006) or thereafter.","['414 subjects', 'Subjects', 'Data were pooled from two phase 3 clinical trials of patients undergoing routine cataract surgery', 'routine cataract surgery', 'Subjects who experienced ≥10 mm Hg, 15 mm Hg, or 20 mm']","['dexamethasone intraocular suspension', 'topical prednisolone', 'dexamethasone intraocular suspension or placebo', 'dexamethasone intraocular suspension or topical prednisolone acetate', 'dexamethasone intraocular suspension 9%) vs placebo (vehicle) injection or topical prednisolone acetate', 'Dexamethasone intraocular suspension', 'prednisolone', 'placebo']","['intraocular pressure (IOP) response', 'mean IOP', 'IOP elevation patterns', 'Hg postoperative IOP', 'intraocular pressure (IOP', 'intraocular pressure', 'risk of postoperative IOP elevation', 'postoperative IOP elevation']","[{'cui': 'C4517771', 'cui_str': '414'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1522223', 'cui_str': 'Intraocular route'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0071839', 'cui_str': 'Prednisolone acetate'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",414.0,0.559046,"Dexamethasone intraocular suspension was associated with a slightly higher mean IOP at the first postoperative visit vs prednisolone (P<0.05); however, mean IOP was not statistically different between the 2 groups by postoperative day 8 (P=0.5006) or thereafter.","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Matossian', 'Affiliation': 'From Matossian Eye Associates (Matossian), Doylestown, Pennsylvania, Harvard Eye Associates (Hovanesian), Laguna Hills, California, North Bay Eye Associates (Bacharach), Petaluma, California, and EyePoint Pharmaceuticals (Paggiarino, Patel), Watertown, Massachusetts, USA. EyePoint Pharmaceuticals (Watertown, Massachusetts, USA) provided funding for this study.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hovanesian', 'Affiliation': ''}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Paggiarino', 'Affiliation': ''}, {'ForeName': 'Keyur', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000363']
2622,32818353,Macular and choroidal thickness after intracameral moxifloxacin for prevention of post-cataract endophthalmitis.,"PURPOSE


To determine any changes in macular or choroidal thickness associated with the use of intracameral moxifloxacin as post-cataract endophthalmitis prophylaxis.
SETTING


University of Campinas (UNICAMP), Campinas, São Paulo, Brazil.
DESIGN


Prospective, randomized, partially masked, single-site clinical trial.
METHODS


Phacoemulsification surgery patients in the experimental group (Group A) received a 0.03 mL intracameral injection of undiluted moxifloxacin from a sealed bottle immediately following phacoemulsification surgery (150 µg in 0.03 mL - Vigamox solution), while the control group (Group B) did not. Investigators evaluated in masked fashion macular and choroidal thickness using spectral domain optical coherence tomography before and after surgery.
RESULTS


A total of 93 patients were included (48 in Group A and 45 in Group B). Baseline parameters were similar between the groups. Either of the 2 parameters assessed differed statistically between the groups or preoperatively vs postoperatively. On postoperative day 30, central macular thickness was 8.85 ± 14.78 μm in Group A and 10.26 ± 22.44 μm in Group B (p=0.7232); choroidal thickness as measured by enhanced depth imaging (EDI) was 1.45 ± 16.13 μm in Group A and 3.74 ± 16.15 in Group B (p=0.5017). On postoperative day 60, central macular thickness was 19.53 ± 39.28 μm in Group A and 17.14 ± 53.68 μm in Group B (p=0.8363); EDI was 5.08 ± 21.96 μm in Group A and 5.24 ± 15.8 in Group B (p=0.9752).
CONCLUSIONS


The application of intracameral injection of 0.03 mL of undiluted 0.5% moxifloxacin during phacoemulsification surgery as endophthalmitis prophylaxis induced no changes in macular or choroidal thickness.",2020,"On postoperative day 60, central macular thickness was 19.53 ± 39.28 μm in Group A and 17.14 ± 53.68 μm in Group B","['Phacoemulsification surgery patients in the experimental group (Group A) received a', 'University of Campinas (UNICAMP), Campinas, São Paulo, Brazil']","['intracameral injection of 0.03 mL of undiluted 0.5% moxifloxacin', '0.03 mL intracameral injection of undiluted moxifloxacin', 'intracameral moxifloxacin']","['central macular thickness', 'Macular and choroidal thickness', 'macular or choroidal thickness', 'choroidal thickness']","[{'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",93.0,0.0468487,"On postoperative day 60, central macular thickness was 19.53 ± 39.28 μm in Group A and 17.14 ± 53.68 μm in Group B","[{'ForeName': 'Bruna Gil', 'Initials': 'BG', 'LastName': 'Ferreira', 'Affiliation': 'From the Department of Ophthalmology and Otorhinolaryngology, School of Medical Sciences, University of Campinas (UNICAMP), São Paulo, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Iuri Cardoso da Silva', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': 'Mathias Violante Mélega', 'Affiliation': ''}, {'ForeName': 'Mauricio Abujamra', 'Initials': 'MA', 'LastName': 'Nascimento', 'Affiliation': ''}, {'ForeName': 'Rodrigo Pessoa', 'Initials': 'RP', 'LastName': 'Cavalcanti Lira', 'Affiliation': ''}, {'ForeName': 'Carlos Eduardo', 'Initials': 'CE', 'LastName': 'Leite Arieta', 'Affiliation': ''}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Alves', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000365']
2623,32818475,"Multimodal physical therapy versus topical lidocaine for provoked vestibulodynia: a prospective, multicentre, randomized trial.","BACKGROUND


Provoked vestibulodynia is the most common subtype of chronic vulvar pain. This highly prevalent and debilitating condition is characterized by acute recurrent pain located at the entry of the vagina in response to pressure application or attempted vaginal penetration. Physical therapy is advocated as a first-line treatment for provoked vestibulodynia but evidence supporting its efficacy is scarce.
OBJECTIVE


The purpose of this study was to establish the efficacy of multimodal physical therapy compared to topical lidocaine, a frequently used first-line treatment.
STUDY DESIGN


We conducted a prospective, multicentre, parallel group, randomized clinical trial in women diagnosed with provoked vestibulodynia recruited from the community and four Canadian university hospitals. Women were randomly assigned (1:1) to receive either weekly sessions of physical therapy or overnight topical lidocaine (5% ointment) for 10 weeks. Randomization was stratified by center using random permuted blocks from a computer-generated list managed by an independent individual. Physical therapy entailed education, pelvic floor muscle exercises with biofeedback, manual therapy and dilation. Assessments were conducted at baseline, post-treatment and 6-month follow-up. Outcome assessors, investigators and data analysts were masked to allocation. The primary outcome was pain intensity during intercourse evaluated with the numerical rating scale (NRS 0-10). Secondary outcomes included pain quality (McGill-Melzack pain questionnaire), sexual function (Female Sexual Function Index), sexual distress (Female Sexual Distress Scale), satisfaction (NRS 0-10) and participants' impression of change (The Patient's Global Impression of Change). Intention-to-treat analyses were conducted using piecewise linear-growth models.
RESULTS


Among 212 women recruited and randomized, 201 (95%) completed the post-treatment assessment and 195 (92%) the 6-month follow-up. Multimodal physical therapy was more effective than lidocaine for reducing pain intensity during intercourse (between groups pre-post slope difference P<0.001; mean group post difference 1.8; 95% confidence interval (CI) 1.2 to 2.3) and results were maintained at 6-month follow-up (mean group difference 1.8, 95%CI 1.2 to 2.5). The physical therapy group also performed better than the lidocaine group in all secondary outcomes (pain quality, sexual function, sexual distress, satisfaction and participants' impression of change) at post-treatment and 6-month follow-up. Moreover, the changes observed following physical therapy were shown to be clinically meaningful. Regarding participants' impression of change, 79% of women in the physical therapy group reported being very much or much improved compared to 39% in the lidocaine group (p<0.001).
CONCLUSION


Findings provide strong evidence that physical therapy is effective for pain, sexual function and sexual distress, and support its recommendation as the first-line treatment of choice for provoked vestibulodynia.",2020,"The physical therapy group also performed better than the lidocaine group in all secondary outcomes (pain quality, sexual function, sexual distress, satisfaction and participants' impression of change) at post-treatment and 6-month follow-up.","['provoked vestibulodynia', '212 women recruited and randomized, 201 (95%) completed the post-treatment assessment and 195 (92%) the 6-month follow-up', 'women diagnosed with provoked vestibulodynia recruited from the community and four Canadian university hospitals']","['Physical therapy entailed education, pelvic floor muscle exercises with biofeedback, manual therapy and dilation', 'lidocaine', 'physical therapy', 'multimodal physical therapy', 'Physical therapy', 'topical lidocaine', 'physical therapy or overnight topical lidocaine', 'Multimodal physical therapy versus topical lidocaine', 'Multimodal physical therapy']","['pain, sexual function and sexual distress', ""pain quality, sexual function, sexual distress, satisfaction and participants' impression of change"", 'pain intensity during intercourse evaluated with the numerical rating scale', ""pain quality (McGill-Melzack pain questionnaire), sexual function (Female Sexual Function Index), sexual distress (Female Sexual Distress Scale), satisfaction (NRS 0-10) and participants' impression of change (The Patient's Global Impression of Change"", 'pain intensity during intercourse']","[{'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0269084', 'cui_str': 'Vulvar vestibulitis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",212.0,0.102992,"The physical therapy group also performed better than the lidocaine group in all secondary outcomes (pain quality, sexual function, sexual distress, satisfaction and participants' impression of change) at post-treatment and 6-month follow-up.","[{'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Morin', 'Affiliation': ""School of Rehabilitation, Faculty of Medicine and Health Sciences, Université de Sherbrooke and Research Center of the Centre hospitalier de l'Université de Sherbrooke (CHUS), Sherbrooke, QC (Canada). Electronic address: melanie.m.morin@usherbrooke.ca.""}, {'ForeName': 'Chantale', 'Initials': 'C', 'LastName': 'Dumoulin', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal and Research Center of the Institut universitaire de gériatrie de Montréal, Montréal, QC (Canada).'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bergeron', 'Affiliation': 'Department of Psychology, University de Montréal, Montréal, QC (Canada).'}, {'ForeName': 'Marie-Hélène', 'Initials': 'MH', 'LastName': 'Mayrand', 'Affiliation': ""Departments of Obstetrics and Gynecology and Social and Preventive Medicine, Université de Montréal and Research Center of the Centre hospitalier de l'Université de Montréal, Montréal, QC (Canada).""}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Khalifé', 'Affiliation': 'Jewish General Hospital and Royal Victoria Hospital, McGill University Health Center, Montréal, QC (Canada).'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Waddell', 'Affiliation': 'Department of Obstetrics and Gynecology, CHUS and Université de Sherbrooke, Sherbrooke, QC (Canada).'}, {'ForeName': 'Marie-France', 'Initials': 'MF', 'LastName': 'Dubois', 'Affiliation': 'Department of Community Health Sciences, Faculty of Medicine and Health Sciences, Université de Sherbrooke and Research Center on Aging, Sherbrooke, QC (Canada).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.08.038']
2624,32818525,A direct comparison of the electrophysiological effects of transcranial direct and alternating current stimulation in healthy subjects.,"OBJECTIVE


Despite the clinical effectiveness of transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS), the comparability of these interventions in neurophysiological aspects have not been thoroughly investigated. Thus, we aimed to directly compare the electrophysiological effects of single-session tDCS and gamma-tACS in healthy subjects, matching the intervention protocol as closely as possible.
METHODS


This was a randomized, double-blinded, and active-controlled study. Sixty healthy college students were enrolled in the study. Both tACS with, at 40 Hz frequency, and tDCS have the same current intensity (2mA, 30min) within the same target area (right and left dorsolateral prefrontal cortex). Resting-state electroencephalography (EEG) was recorded before and after single-session stimulation.
RESULTS


Significant differences in theta, alpha, low-beta, and gamma frequencies were found between tDCS, tACS, and the sham groups. Low-beta source activity of the middle temporal gyrus was decreased only after an intervention with tACS.
CONCLUSION


The present study indicates that tDCS and tACS resulted in an increased range of frequency activity, including slow- and fast-wave bands. Specifically, tDCS modulates the frontal region, while tACS modulates neural oscillations at the fronto-central, parietal, and temporal areas. The tACS also decreased low-beta source activity in the middle temporal gyrus. Identifying the common and unique EEG patterns of tDCS and tACS may help shed light on their potential clinical benefits and distinctive neuropathology in various clinical symptoms.",2020,"RESULTS


Significant differences in theta, alpha, low-beta, and gamma frequencies were found between tDCS, tACS, and the sham groups.","['healthy subjects', 'Sixty healthy college students']","['tDCS and tACS', 'transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS', 'single-session tDCS and gamma-tACS', 'transcranial direct and alternating current stimulation']","['Low-beta source activity', 'range of frequency activity', 'theta, alpha, low-beta, and gamma frequencies', 'low-beta source activity', 'Resting-state electroencephalography (EEG']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0442830', 'cui_str': 'Alternating current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",60.0,0.0531433,"RESULTS


Significant differences in theta, alpha, low-beta, and gamma frequencies were found between tDCS, tACS, and the sham groups.","[{'ForeName': 'Jiheon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chuncheon Sacred Heart Hospital, Chuncheon, Republic of Korea; Mind-Neuromodulation Laboratory, College of Medicine, Hallym University, Chuncheon, Republic of Korea.'}, {'ForeName': 'Kuk-In', 'Initials': 'KI', 'LastName': 'Jang', 'Affiliation': 'Department of Cognitive Science Research, Korea Brain Research Institute, Republic of Korea.'}, {'ForeName': 'Daeyoung', 'Initials': 'D', 'LastName': 'Roh', 'Affiliation': 'Department of Psychiatry, Chuncheon Sacred Heart Hospital, Chuncheon, Republic of Korea; Mind-Neuromodulation Laboratory, College of Medicine, Hallym University, Chuncheon, Republic of Korea.'}, {'ForeName': 'Hansol', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Mind-Neuromodulation Laboratory, College of Medicine, Hallym University, Chuncheon, Republic of Korea.'}, {'ForeName': 'Do-Hoon', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Chuncheon Sacred Heart Hospital, Chuncheon, Republic of Korea; Mind-Neuromodulation Laboratory, College of Medicine, Hallym University, Chuncheon, Republic of Korea. Electronic address: dhkim0824@gmail.com.'}]",Brain research,['10.1016/j.brainres.2020.147065']
2625,32818963,Randomized Phase 2 Study of VT-1161 for the Treatment of Acute Vulvovaginal Candidiasis.,"BACKGROUND


Acute vulvovaginal candidiasis (VVC) is common among women, but current azole antifungal treatments are often associated with safety and resistance issues. VT-1161 (otesaconazole) is an oral agent with increased selectivity for fungal CYP51. This Phase 2 clinical study evaluated the efficacy and safety of VT-1161 versus fluconazole in subjects with moderate-to-severe acute VVC.
METHODS


Female subjects presenting with an acute episode of VVC (n=55) were randomized to receive VT-1161 300 mg once daily (q.d.) for 3 days, 600 mg q.d. for 3 days, or 600 mg twice daily (b.i.d.) for 3 days, or a single dose of fluconazole 150 mg (current FDA-approved dose to treat acute VVC). Subjects were followed for 6 months. The primary outcome was the proportion of subjects with therapeutic (clinical and mycological) cure at Day 28.
RESULTS


A larger proportion of subjects in the per-protocol population experienced therapeutic cure in the VT1161 300 mg q.d. (75.0%), VT1161 600 mg q.d. (85.7%), and VT1161 600 mg b.i.d. (78.6%) groups versus the fluconazole group (62.5%); differences were not statistically significant. At 3 and 6 months, no subjects in the VT-1161 groups versus 28.5% and 46.1% of subjects in the fluconazole group, respectively, had evidence of mycological recurrence. No serious adverse events or treatment-emergent adverse events leading to discontinuation were reported.
CONCLUSIONS


The majority of subjects across all treatment groups achieved therapeutic cure at Day 28 in the VT-1161 and fluconazole groups. VT-1161 was well tolerated at all dose levels through 6 months of follow-up.ClinicalTrials.gov identifier: NCT01891331.",2020,The majority of subjects across all treatment groups achieved therapeutic cure at Day 28 in the VT-1161 and fluconazole groups.,"['Acute vulvovaginal candidiasis (VVC', 'Acute Vulvovaginal Candidiasis', 'Female subjects presenting with an acute episode of VVC (n=55', 'subjects with moderate-to-severe acute VVC']","['VT-1161', 'VT-1161 (otesaconazole', 'VT-1161 300\xa0mg once daily', 'fluconazole', 'VT-1161 versus fluconazole', 'fluconazole 150\xa0mg (current FDA-approved dose to treat acute VVC']","['tolerated', 'efficacy and safety', 'mycological recurrence', 'proportion of subjects with therapeutic (clinical and mycological) cure', 'therapeutic cure']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0700345', 'cui_str': 'Candidal vulvovaginitis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C4043593', 'cui_str': 'VT-1161'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}, {'cui': 'C0986074', 'cui_str': 'Fluconazole 150 MG'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",,0.0310912,The majority of subjects across all treatment groups achieved therapeutic cure at Day 28 in the VT-1161 and fluconazole groups.,"[{'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Brand', 'Affiliation': 'Viamet Pharmaceuticals, Durham, NC, USA.'}, {'ForeName': 'Jack D', 'Initials': 'JD', 'LastName': 'Sobel', 'Affiliation': 'School of Medicine, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Nyirjesy', 'Affiliation': 'Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Mahmoud A', 'Initials': 'MA', 'LastName': 'Ghannoum', 'Affiliation': 'Center for Medical Mycology, Case Western Reserve University, and University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Schotzinger', 'Affiliation': 'Viamet Pharmaceuticals, Durham, NC, USA.'}, {'ForeName': 'Thorsten P', 'Initials': 'TP', 'LastName': 'Degenhardt', 'Affiliation': 'Viamet Pharmaceuticals, Durham, NC, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1204']
2626,32819025,Effectiveness of a Simple Auditory Feedback Insole (Sim-Insole) for Touchdown Weight-Bearing Training in At-Risk Volunteers with Poor Compliance: A Crossover Study.,"INTRODUCTION


Recent studies have shown that biofeedback devices are effective for weight-bearing (WB) training. However, these devices have limitations due to high costs and inadequate evidence of their effectiveness among poor-compliance individuals. This study aimed to assess WB compliance after touchdown weight-bearing (TDWB) training by the standard bathroom scale (BS) method and to evaluate the efficacy of our innovative simple auditory feedback device (Sim-Insole).
METHODS


In this crossover study, healthy volunteers were trained for TDWB (targeting 20% of bodyweight [BW]) with the BS method and assessed with the Sim-Insole without feedback (phase 1), and then completed a 30-min wash-out period and underwent re-assessment with Sim-Insole with feedback (phase 2). Satisfaction was evaluated with a self-assessment questionnaire. Those who had and had not experienced a weight-bearing force (WBF) >25% of BW were classified as high-risk and low-risk groups, respectively. Steps with percentage of WB &15%, 15%-25%, and >25% were defined as under-zone, in-zone, and over-zone, respectively.
RESULTS


Fourteen volunteers (70%) were classified as high-risk after the BS method. Without auditory feedback, the high-risk group demonstrated a significantly higher average percentage of WB and higher average lowest WBF compared to the low-risk group (18.8% vs. 13.7% and 74.3N vs. 60.2N, respectively, p=0.002 for both). With the use of auditory feedback with Sim-Insole in the high-risk group, the cadence, percentage of WB, highest absolute WBF, proportion of over-zone step, and confidence for TDWB improved significantly compared to those with the BS method (p&0.05 for all). However, the low-risk group showed only a significant improvement in cadence (p=0.047) and a non-significant trend for improvement in the percentage of WB (p=0.089), compared to the BS method.
CONCLUSION


Sim-Insole is effective for TDWB training. This device significantly improved WB compliance with regard to excessive WB, walking speed, and the confidence of volunteers in the high-risk group with poor compliance.",2020,"However, the low-risk group showed only a significant improvement in cadence (p=0.047) and a non-significant trend for improvement in the percentage of WB (p=0.089), compared to the BS method.
","['healthy volunteers', 'Fourteen volunteers (70%) were classified as high-risk after the BS method', 'At-Risk Volunteers with Poor Compliance']","['BS method and assessed with the Sim-Insole without feedback (phase 1), and then completed a 30-min wash-out period and underwent re-assessment with Sim-Insole with feedback', 'innovative simple auditory feedback device (Sim-Insole', 'Touchdown Weight-Bearing Training', 'Simple Auditory Feedback Insole (Sim-Insole', 'touchdown weight-bearing (TDWB) training']","['WB compliance', 'cadence, percentage of WB, highest absolute WBF, proportion of over-zone step, and confidence for TDWB', 'percentage of WB', 'cadence', 'Satisfaction', 'weight-bearing force (WBF']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0040364', 'cui_str': 'Lavatory'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]","[{'cui': 'C0040364', 'cui_str': 'Lavatory'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3873740', 'cui_str': 'Insole'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",14.0,0.0294318,"However, the low-risk group showed only a significant improvement in cadence (p=0.047) and a non-significant trend for improvement in the percentage of WB (p=0.089), compared to the BS method.
","[{'ForeName': 'Chaiyanun', 'Initials': 'C', 'LastName': 'Vijittrakarnrung', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Udomporn', 'Initials': 'U', 'LastName': 'Manupibul', 'Affiliation': 'Department of Biomedical Engineering, Faculty of Engineering, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Warakorn', 'Initials': 'W', 'LastName': 'Charoensuk', 'Affiliation': 'Department of Biomedical Engineering, Faculty of Engineering, Mahidol University, Nakhon Pathom, Thailand, SMART Motion Analysis and Rehabilitation Technology Laboratory, Department of Biomedical Engineering, Faculty of Engineering, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Ratikanlaya', 'Initials': 'R', 'LastName': 'Tanthuwapathom', 'Affiliation': 'Department of Biomedical Engineering, Faculty of Engineering, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Wimonrat', 'Initials': 'W', 'LastName': 'Jarumethitanont', 'Affiliation': 'Department of Biomedical Engineering, Faculty of Engineering, Mahidol University, Nakhon Pathom, Thailand, Department of Physical Therapy, Faculty of Physical Therapy, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Paphon', 'Initials': 'P', 'LastName': 'Sa-Ngasoongsong', 'Affiliation': 'Department of Orthopedics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",Surgical technology international,[]
2627,32819048,Comparison between two different concentrations of a fixed dose of ropivacaine in interscalene brachial plexus block for pain management after arthroscopic shoulder surgery: a randomized clinical trial.,"Background


To compare the effects of two different concentrations of a fixed dose of ropivacaine used in ultrasound-guided interscalene brachial plexus block for postoperative analgesia after arthroscopic shoulder surgery.
Methods


This prospective, randomized, double-blind study included 62 patients who underwent arthroscopic surgery under general anesthesia. The patients were randomly assigned to receive ultrasound-guided interscalene block with 75 mg of ropivacaine at one of two concentrations: 0.75% (10 ml; group C) or 0.375% (20 ml; group V). Time to onset of sensory and motor blockade, degree of motor and sensory blockade, pulmonary function changes, analgesic duration of the interscalene block, postoperative opioid requirement within 24 hours, postoperative pain scores, satisfaction score related to pain control, and incidence of complications related to the block were recorded.
Results


Although the time to onset of sensory blockade was shorter for group C (P = 0.015), successful blockade was achieved at 30 min after the interscalene block in both groups. The analgesic duration of the interscalene block was not significantly different between the groups. The amount of opioid used within 24 hours after surgery was significantly reduced for group V compared with group C (P = 0.016).
Conclusion


Compared with 10 ml of 0.75% ropivacaine, 20 ml of 0.375% ropivacaine did not prolong the analgesic duration of interscalene block. Nevertheless, it could be effective for the reduction of postoperative opioid requirement within 24 hours after surgery.",2020,"Although the time to onset of sensory blockade was shorter for group C (P = 0.015), successful blockade was achieved at 30 min after the interscalene block in both groups.","['pain management after arthroscopic shoulder surgery', '62 patients who underwent arthroscopic surgery under general anesthesia']","['ultrasound-guided interscalene block with 75 mg of ropivacaine', 'ropivacaine', 'interscalene brachial plexus block', 'ultrasound-guided interscalene brachial plexus block']","['successful blockade', 'Time to onset of sensory and motor blockade, degree of motor and sensory blockade, pulmonary function changes, analgesic duration of the interscalene block, postoperative opioid requirement within 24 hours, postoperative pain scores, satisfaction score related to pain control, and incidence of complications', 'postoperative opioid requirement', 'analgesic duration of interscalene block', 'analgesic duration of the interscalene block', 'time to onset of sensory blockade']","[{'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0186321', 'cui_str': 'Operative procedure on shoulder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750934', 'cui_str': 'Arthroscopy with surgical procedure'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0394698', 'cui_str': 'Brachial plexus block by interscalene approach'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",62.0,0.190894,"Although the time to onset of sensory blockade was shorter for group C (P = 0.015), successful blockade was achieved at 30 min after the interscalene block in both groups.","[{'ForeName': 'Seung Cheol', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Joon Ho', 'Initials': 'JH', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Seong Yeop', 'Initials': 'SY', 'LastName': 'Jeong', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Sung Wan', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Chan Jong', 'Initials': 'CJ', 'LastName': 'Chung', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'So Ron', 'Initials': 'SR', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Jeong Ho', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}, {'ForeName': 'Sang Yoong', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Dong-A University College of Medicine, Busan, Korea.'}]",Korean journal of anesthesiology,['10.4097/kja.20353']
2628,32819145,General versus Local Anesthesia with Conscious Sedation in Transcatheter Aortic Valve Implantation: The Randomized SOLVE-TAVI Trial.,"Background:  In clinical practice, local anesthesia with conscious sedation (CS) is performed in roughly 50% of patients undergoing transcatheter aortic valve replacement (TAVR). However, no randomized data assessing the safety and efficacy of CS versus general anesthesia (GA) are available.  Methods:  SOLVE-TAVI is a multicenter, open-label, 2x2 factorial, randomized trial of 447 patients with aortic stenosis undergoing transfemoral TAVR comparing CS versus GA. The primary efficacy endpoint was powered for equivalence (equivalence margin 10% with significance level 0.05) and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days.  Results:  The primary composite endpoint occurred in 27.2% of CS and 26.4% of GA patients (rate difference 0.8 [90%CI -6.2 to 7.8]; P equivalence =0.015). Event rates for the individual components were as follows: all-cause mortality 3.2% versus 2.3% (rate difference 1.0 [90%CI - 2.9 to 4.8]; P equivalence <0.001), stroke 2.4% versus 2.8% (rate difference -0.4 [90%CI -3.8 to 3.8]; P equivalence <0.001), myocardial infarction 0.5% versus 0.0% (rate difference 0.5 [90%CI -3.0 to 3.9]; P equivalence <0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference -0.9 [90%CI -7.5 to 5.7]; P equivalence =0.011), acute kidney injury 9.0% versus 9.2% (rate difference - 0.2 [90%CI -5.2 to 4.8]; P equivalence =0.0005). There was a lower need for inotropes or vasopressors with CS (62.8%) versus GA (97.3%) (rate difference -34.4 [90%CI -41.0 to -27.8]).  Conclusions:  Among patients with aortic stenosis undergoing transfemoral TAVR, use of CS compared with GA resulted in similar outcomes for the primary efficacy endpoint. These findings suggest that CS can be safely applied for TAVR.  Clinical Trial Registration:  URL: https://clinicaltrials.gov Unique Identifier: NCT02737150.",2020,"Event rates for the individual components were as follows: all-cause mortality 3.2% versus 2.3% (rate difference 1.0 [90%CI - 2.9 to 4.8]; P equivalence <0.001), stroke 2.4% versus 2.8% (rate difference -0.4 [90%CI -3.8 to 3.8]; P equivalence <0.001), myocardial infarction 0.5% versus 0.0% (rate difference 0.5 [90%CI -3.0 to 3.9]; P equivalence <0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference -0.9","['447 patients with aortic stenosis undergoing transfemoral TAVR comparing CS versus GA', 'Transcatheter Aortic Valve Implantation', 'patients with aortic stenosis undergoing transfemoral TAVR, use of', 'patients undergoing transcatheter aortic valve replacement (TAVR']","['GA', 'local anesthesia with conscious sedation (CS', 'CS', 'Local Anesthesia with Conscious Sedation']","['infection requiring antibiotics', 'acute kidney injury', 'myocardial infarction', 'equivalence (equivalence margin 10% with significance level 0.05) and consisted of the composite of all-cause mortality, stroke, myocardial infarction, infection requiring antibiotic treatment, and acute kidney injury at 30 days', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C1524063', 'cui_str': 'Use of'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",447.0,0.244605,"Event rates for the individual components were as follows: all-cause mortality 3.2% versus 2.3% (rate difference 1.0 [90%CI - 2.9 to 4.8]; P equivalence <0.001), stroke 2.4% versus 2.8% (rate difference -0.4 [90%CI -3.8 to 3.8]; P equivalence <0.001), myocardial infarction 0.5% versus 0.0% (rate difference 0.5 [90%CI -3.0 to 3.9]; P equivalence <0.001), infection requiring antibiotics 21.1% versus 22.0% (rate difference -0.9","[{'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kurz', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Lübeck, Germany; German Center for Cardiovascular Research (DZHK), Germany.'}, {'ForeName': 'Hans-Josef', 'Initials': 'HJ', 'LastName': 'Feistritzer', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Stachel', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Hartung', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Lurz', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Eitel', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Lübeck, Germany; German Center for Cardiovascular Research (DZHK), Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Marquetand', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Lübeck, Germany; German Center for Cardiovascular Research (DZHK), Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Nef', 'Affiliation': 'Universitätsklinikum Marburg/Gießen, Gießen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Doerr', 'Affiliation': 'Universitätsklinikum Marburg/Gießen, Gießen, Germany.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Vigelius-Rauch', 'Affiliation': 'Universitätsklinikum Marburg/Gießen, Gießen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Lauten', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Germany; Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Germany; Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Sascha', 'Initials': 'S', 'LastName': 'Treskatsch', 'Affiliation': 'Universitätsklinikum Charité, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Sandri', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Holzhey', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Borger', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Ender', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Ince', 'Affiliation': 'Universitätsklinikum Rostock, Rostock, Germany.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Öner', 'Affiliation': 'Universitätsklinikum Rostock, Rostock, Germany.'}, {'ForeName': 'Roza', 'Initials': 'R', 'LastName': 'Meyer-Saraei', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Lübeck, Germany; German Center for Cardiovascular Research (DZHK), Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Hambrecht', 'Affiliation': 'Klinikum Links der Weser, Bremen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fach', 'Affiliation': 'Klinikum Links der Weser, Bremen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Augenstein', 'Affiliation': 'Klinikum Links der Weser, Bremen, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Frey', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), Germany; University Clinic SchleswigHolstein, Kiel, Germany.'}, {'ForeName': 'Inke R', 'Initials': 'IR', 'LastName': 'König', 'Affiliation': 'Institut für Medizinische Biometrie und Statistik, University of Lübeck, Lübeck, Germany; German Center for Cardiovascular Research (DZHK), Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Vonthein', 'Affiliation': 'Institut für Medizinische Biometrie und Statistik, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Rückert', 'Affiliation': 'Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Anne-Kathrin', 'Initials': 'AK', 'LastName': 'Funkat', 'Affiliation': 'Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany; German Center for Cardiovascular Research (DZHK), Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Heart Center Leipzig at University of Leipzig, Leipzig, Germany; Leipzig Heart Institute, Leipzig, Germany; German Center for Cardiovascular Research (DZHK), Germany.'}, {'ForeName': 'Astrid E', 'Initials': 'AE', 'LastName': 'Berggreen', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Lübeck, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Heringlake', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Lübeck, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'University Clinic Schleswig-Holstein and University Heart Center Lübeck, Lübeck, Germany; German Center for Cardiovascular Research (DZHK), Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.046451']
2629,32819321,Pain trajectories of dorsomedial prefrontal intermittent theta burst stimulation versus sham treatment in depression.,"BACKGROUND


Prefrontal repetitive transcranial magnetic stimulation is an established add-on treatment for major depressive disorder and is increasingly feasible with protocols of short duration, such as intermittent theta burst stimulation (iTBS). The most common and limiting side effect is pain at the site of application. Our objective was to investigate how pain develops over time in patients with depression receiving iTBS compared to sham stimulation.
METHODS


This is a subsample from a randomized clinical trial. Patients received daily sessions of 2400 pulses of dorsomedial prefrontal iTBS or sham stimulation with transcutaneous electric stimulation during 2 to 3 weeks. After unmasking of treatment allocation, patients receiving sham treatment were offered active iTBS in an open phase. Patients rated pain on a scale from 0 to 10 after the last train of stimulation on the first, fifth and final treatment day. A Mann-Whitney U-test was conducted to test for group differences and related-samples Friedman's tests to analyze changes in pain ratings over time.
RESULTS


The scalp pain in the group receiving iTBS was rated higher than sham treatment on the first (U = 263.5, p = 0.035) and fifth day (U = 271.0, p = 0.020) but not on the final day (U = 210.5, p = 0.121). The pain decreased mainly during the first 5 days of treatment (χ 2  = 0.875, p = 0.040). In the open phase the pain decreased from the first day to the final day (χ 2  = 1.194, p = 0.001).
CONCLUSIONS


The subjective pain perception of active dorsomedial iTBS was higher than sham treatment but decreased over time, indicating an analgesic effect, or habituation. The result from this study can be used to inform patients about what to expect regarding pain during an iTBS treatment course.
TRIAL REGISTRATION


Clinicaltrials.gov, NCT02905604 . Registered 19 September 2016.",2020,"The pain decreased mainly during the first 5 days of treatment (χ 2  = 0.875, p = 0.040).",['patients with depression receiving'],"['iTBS', 'daily sessions of 2400 pulses of dorsomedial prefrontal iTBS or sham stimulation with transcutaneous electric stimulation', 'dorsomedial prefrontal intermittent theta burst stimulation']","['analgesic effect, or habituation', 'active iTBS', 'Pain trajectories', 'subjective pain perception of active dorsomedial iTBS', 'pain', 'pain ratings', 'scalp pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]","[{'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0013170', 'cui_str': 'Drug habituation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0240940', 'cui_str': 'Scalp pain'}]",,0.10188,"The pain decreased mainly during the first 5 days of treatment (χ 2  = 0.875, p = 0.040).","[{'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Malm', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University Hospital, Entrance 10, Ground floor, SE-751 85, Uppsala, Sweden.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Struckmann', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University Hospital, Entrance 10, Ground floor, SE-751 85, Uppsala, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Persson', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University Hospital, Entrance 10, Ground floor, SE-751 85, Uppsala, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bodén', 'Affiliation': 'Department of Neuroscience, Psychiatry, Uppsala University Hospital, Entrance 10, Ground floor, SE-751 85, Uppsala, Sweden. robert.boden@neuro.uu.se.'}]",BMC neurology,['10.1186/s12883-020-01881-3']
2630,32819331,Cognitive behavioral therapy for overactive bladder in women: study protocol for a randomized controlled trial.,"BACKGROUND


Overactive bladder (OAB) symptoms affect daily life by decreasing health-related quality of life (HRQol). However, there remain no very effective treatment for OAB. Pharmacotherapy is one of the best treatments, but it is not always efficient and may incur adverse events. Although behavioral therapy is another effective treatment, there are very few structured treatment manuals on how to prescribe behavioral therapy to treat OAB for whom. Cognitive behavioral therapy (CBT) is a psychotherapy consisting of structured sessions to solve problems with the collaborative empiricism between therapists and patients. OAB symptoms are supposed to worsen with cognitive distortion, and CBT is expected to be effective in treating OAB by modifying such cognitive processes. In this trial, we will evaluate the efficacy of CBT for OAB.
METHODS


A randomized, controlled, open-label, multicenter parallel-group superiority trial will be conducted. Participants with moderate to severe OAB symptoms with or without pharmacotherapy will be recruited and will be randomly allocated 1:1 to two different groups by minimization (age, baseline OAB severity, treatment status, types of intervention, and treating institutions). The intervention group will be prescribed an individual CBT program covering six techniques in 4 sessions (30 min each), with or without pharmacotherapy. The primary outcome is the change scores in an OAB-questionnaire (OAB-q) from baseline to the end of the trial (week 13). Secondary outcomes will include other patient reported outcome measures and the frequency volume chart. All analyses will be conducted on an intention-to-treat principle.
DISCUSSION


This trial will determine the efficacy of CBT to treat OAB using a rigorous methodology. The effectiveness of CBT with a structured manual may not only lead to a new treatment option for patients suffering from OAB symptoms, but may also reduce the social burden by OAB.
TRIAL REGISTRATION


UMIN-CTR Clinical Trial, CTR-UMIN000038513 . Registered on November 7, 2019.",2020,"The effectiveness of CBT with a structured manual may not only lead to a new treatment option for patients suffering from OAB symptoms, but may also reduce the social burden by OAB.
","['Participants with moderate to severe OAB symptoms with or without', 'patients suffering from OAB symptoms', 'overactive bladder in women']","['CBT', 'pharmacotherapy', 'Cognitive behavioral therapy', 'Cognitive behavioral therapy (CBT', 'individual CBT program covering six techniques in 4 sessions (30\u2009min each), with or without pharmacotherapy']",['change scores in an OAB-questionnaire (OAB-q'],"[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.116359,"The effectiveness of CBT with a structured manual may not only lead to a new treatment option for patients suffering from OAB symptoms, but may also reduce the social burden by OAB.
","[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Funada', 'Affiliation': 'Department of Urology, Kyoto University Graduate School of Medicine, 54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan. sfunada@kuhp.kyoto-u.ac.jp.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Watanabe', 'Affiliation': 'Department of Health Promotion and Human Behavior, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Goto', 'Affiliation': 'Department of Urology, Kyoto University Graduate School of Medicine, 54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Negoro', 'Affiliation': 'Department of Urology, University of Tsukuba Hospital, Tsukuba, Japan.'}, {'ForeName': 'Shusuke', 'Initials': 'S', 'LastName': 'Akamatsu', 'Affiliation': 'Department of Urology, Kyoto University Graduate School of Medicine, 54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ueno', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Uozumi', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ichioka', 'Affiliation': 'Ichioka Urological Clinic, Kyoto, Japan.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Segawa', 'Affiliation': 'Department of Urology, Kyoto City Hospital, Kyoto, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.'}, {'ForeName': 'Toshiaki A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Department of Health Promotion and Human Behavior, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ogawa', 'Affiliation': 'Department of Urology, Kyoto University Graduate School of Medicine, 54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, 606-8507, Japan.'}]",BMC urology,['10.1186/s12894-020-00697-0']
2631,32819350,"Intellectual disability, exercise and aging: the IDEA study: study protocol for a randomized controlled trial.","BACKGROUND


People with intellectual disabilities (ID) have low levels of physical activity (PA) together with accelerated aging profiles. Adherence to PA interventions for persons with ID is low based on barriers such as motivation. The IDEA study aims to determine the effect of two types of exercise programs, continuous aerobic (CAEP) vs sprint interval training (SIT), designed for seniors with ID on health-related physical fitness, cardiovascular parameters, quality of life (QoL), and emotional and cognitive function.
METHODS


In this trial, ninety seniors with ID between the ages of 40 and 75 yrs. from occupational health centers from the Autonomous Region of Catalonia (Spain) will be recruited. Participants will be randomly allocated to the CAEP, SIT, and control group. Both intervention groups will train 3 days/week, 1.5 h/day over 6 months. Outcome variables will be assessed at baseline, 6 months and 12 months. The outcome variables include weight, height, body composition, cardiorespiratory fitness, muscle strength, balance, flexibility, cardiovascular parameters (blood pressure, pulse-wave velocity, pulse-wave analysis), QoL and cognitive function. The intervention effect will be determined with mixed models with repeated measures to assess changes in the outcome variables over time (baseline to month 12) and between study arms. Relationship between variables will be analyzed with appropriate regression analyses.
DISCUSSION


Various studies reported on CAEP and SIT as exercise interventions for persons with ID with beneficial outcomes on body composition, fitness and blood pressure. To our knowledge, this is the first trial designed to analyse the positive changes on fitness, PA levels, cardiovascular, QoL and cognitive function promoted by CAEP training and SIT in seniors with ID. The findings of this study will assist in the development of more effective exercise interventions to ensure better compliance and adherence to exercise in seniors with ID.
TRIAL REGISTRATION


The trial is registered at the ISRCTN registry. Registration number: ISRCTN43594228 . Registered 11 February 2019 - Retrospectively registered.",2020,"Various studies reported on CAEP and SIT as exercise interventions for persons with ID with beneficial outcomes on body composition, fitness and blood pressure.","['People with intellectual disabilities (ID', 'seniors with ID on health-related', 'seniors with ID', 'from occupational health centers from the Autonomous Region of Catalonia (Spain', 'Registered 11 February 2019 - Retrospectively registered', 'persons with ID', 'ninety seniors with ID between the ages of 40 and 75\u2009yrs']","['exercise programs, continuous aerobic (CAEP) vs sprint interval training (SIT', 'CAEP, SIT, and control group']","['physical fitness, cardiovascular parameters, quality of life (QoL), and emotional and cognitive function', 'fitness, PA levels, cardiovascular, QoL and cognitive function', 'weight, height, body composition, cardiorespiratory fitness, muscle strength, balance, flexibility, cardiovascular parameters (blood pressure, pulse-wave velocity, pulse-wave analysis), QoL and cognitive function', 'body composition, fitness and blood pressure']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0079920', 'cui_str': 'Occupational Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C3494430', 'cui_str': 'Pulse Wave Analysis'}]",90.0,0.0951115,"Various studies reported on CAEP and SIT as exercise interventions for persons with ID with beneficial outcomes on body composition, fitness and blood pressure.","[{'ForeName': 'Guillermo R', 'Initials': 'GR', 'LastName': 'Oviedo', 'Affiliation': 'Faculty of Psychology, Education and Sport Science Blanquerna, University Ramon Llull, Barcelona, Spain. guillermorubeno@blanqnuerna.url.edu.'}, {'ForeName': 'Casimiro', 'Initials': 'C', 'LastName': 'Javierre', 'Affiliation': 'Department of Physiological Sciences, School of Medicine, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Font-Farré', 'Affiliation': 'Faculty of Psychology, Education and Sport Science Blanquerna, University Ramon Llull, Barcelona, Spain.'}, {'ForeName': 'Nauris', 'Initials': 'N', 'LastName': 'Tamulevicius', 'Affiliation': 'Department of Health Sciences and Human Performance, College of Natural and Health Sciences, The University of Tampa, Tampa, Florida, USA.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Carbó-Carreté', 'Affiliation': 'Faculty of Psychology, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Figueroa', 'Affiliation': 'Department of Kinesiology and Sport Management, Texas Tech University, Lubbock, TX, USA.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Pérez-Testor', 'Affiliation': 'Faculty of Psychology, Education and Sport Science Blanquerna, University Ramon Llull, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Cabedo-Sanromá', 'Affiliation': 'Faculty of Psychology, Education and Sport Science Blanquerna, University Ramon Llull, Barcelona, Spain.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Moss', 'Affiliation': 'Physical Activity, Sport and Recreation Research Focus Area, Faculty of Health Sciences, North-West University, Potchefstroom, South Africa.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Massó-Ortigosa', 'Affiliation': 'School of Health Science Blanquerna, University Ramon Llull, Barcelona, Spain.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Guerra-Balic', 'Affiliation': 'Faculty of Psychology, Education and Sport Science Blanquerna, University Ramon Llull, Barcelona, Spain.'}]",BMC public health,['10.1186/s12889-020-09353-6']
2632,32819352,A randomised controlled trial of feedback to improve patient satisfaction and consultation skills in medical students.,"BACKGROUND


The use of feedback has been integral to medical student learning, but rigorous evidence to evaluate its education effect is limited, especially in the role of patient feedback in clinical teaching and practice improvement. The aim of the Patient Teaching Associate (PTA) Feedback Study was to evaluate whether additional written consumer feedback on patient satisfaction improved consultation skills among medical students and whether multisource feedback (MSF) improved student performance.
METHODS


In this single site, double-blinded randomised controlled trial, 71 eligible medical students from two universities in their first clinical year were allocated to intervention or control and followed up for one semester. They participated in five simulated student-led consultations in a teaching clinic with patient volunteers living with chronic illness. Students in the intervention group received additional written feedback on patient satisfaction combined with guided self-reflection. The control group received usual immediate formative multisource feedback from tutors, patients and peers. Student characteristics, baseline patient-rated satisfaction scores and tutor-rated consultation skills were measured.
RESULTS


Follow-up assessments were complete in 70 students attending the MSF program. At the final consultation episodes, both groups improved patient-rated rapport (P = 0.002), tutor-rated patient-centeredness and tutor-rated overall consultation skills (P = 0.01). The intervention group showed significantly better tutor-rated patient-centeredness (P = 0.003) comparing with the control group. Distress relief, communication comfort, rapport reported by patients and tutor-rated clinical skills did not differ significantly between the two groups.
CONCLUSIONS


The innovative multisource feedback program effectively improved consultation skills in medical students. Structured written consumer feedback combined with guided student reflection further improved patient-centred practice and effectively enhanced the benefit of an MSF model. This strategy might provide a valuable adjunct to communication skills education for medical students.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry Number ACTRN12613001055796 .",2020,"Distress relief, communication comfort, rapport reported by patients and tutor-rated clinical skills did not differ significantly between the two groups.
","['71 eligible medical students from two universities in their first clinical year', 'patient volunteers living with chronic illness', 'medical students', '70 students attending the MSF program']","['additional written feedback on patient satisfaction combined with guided self-reflection', 'usual immediate formative multisource feedback']","['patient-rated rapport', 'consultation skills', 'Student characteristics, baseline patient-rated satisfaction scores and tutor-rated consultation skills', 'Distress relief, communication comfort, rapport reported by patients and tutor-rated clinical skills', 'tutor-rated patient-centeredness and tutor-rated overall consultation skills', 'patient satisfaction and consultation skills', 'better tutor-rated patient-centeredness']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008973', 'cui_str': 'Clinical Skills'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",71.0,0.167151,"Distress relief, communication comfort, rapport reported by patients and tutor-rated clinical skills did not differ significantly between the two groups.
","[{'ForeName': 'Michelle M Y', 'Initials': 'MMY', 'LastName': 'Lai', 'Affiliation': 'Medical Student Programs, Eastern Health Clinical School, Monash University and Deakin University, Level 2, Arnold Street, Box Hill, VIC, 3128, Australia. michelle.m.lai@curtin.edu.au.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Roberts', 'Affiliation': 'Medical Student Programs, Eastern Health Clinical School, Monash University and Deakin University, Level 2, Arnold Street, Box Hill, VIC, 3128, Australia.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Geelong, Australia.'}, {'ForeName': 'Jenepher', 'Initials': 'J', 'LastName': 'Martin', 'Affiliation': 'Medical Student Programs, Eastern Health Clinical School, Monash University and Deakin University, Level 2, Arnold Street, Box Hill, VIC, 3128, Australia.'}]",BMC medical education,['10.1186/s12909-020-02171-9']
2633,32819390,Circulating tumor DNA guided adjuvant chemotherapy in stage II colon cancer (MEDOCC-CrEATE): study protocol for a trial within a cohort study.,"BACKGROUND


Accurate detection of patients with minimal residual disease (MRD) after surgery for stage II colon cancer (CC) remains an urgent unmet clinical need to improve selection of patients who might benefit form adjuvant chemotherapy (ACT). Presence of circulating tumor DNA (ctDNA) is indicative for MRD and has high predictive value for recurrent disease. The MEDOCC-CrEATE trial investigates how many stage II CC patients with detectable ctDNA after surgery will accept ACT and whether ACT reduces the risk of recurrence in these patients.
METHODS/DESIGN


MEDOCC-CrEATE follows the 'trial within cohorts' (TwiCs) design. Patients with colorectal cancer (CRC) are included in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) and give informed consent for collection of clinical data, tissue and blood samples, and consent for future randomization. MEDOCC-CrEATE is a subcohort within PLCRC consisting of 1320 stage II CC patients without indication for ACT according to current guidelines, who are randomized 1:1 into an experimental and a control arm. In the experimental arm, post-surgery blood samples and tissue are analyzed for tissue-informed detection of plasma ctDNA, using the PGDx elio™ platform. Patients with detectable ctDNA will be offered ACT consisting of 8 cycles of capecitabine plus oxaliplatin while patients without detectable ctDNA and patients in the control group will standard follow-up according to guideline. The primary endpoint is the proportion of patients receiving ACT when ctDNA is detectable after resection. The main secondary outcome is 2-year recurrence rate (RR), but also includes 5-year RR, disease free survival, overall survival, time to recurrence, quality of life and cost-effectiveness. Data will be analyzed by intention to treat.
DISCUSSION


The MEDOCC-CrEATE trial will provide insight into the willingness of stage II CC patients to be treated with ACT guided by ctDNA biomarker testing and whether ACT will prevent recurrences in a high-risk population. Use of the TwiCs design provides the opportunity to randomize patients before ctDNA measurement, avoiding ethical dilemmas of ctDNA status disclosure in the control group.
TRIAL REGISTRATION


Netherlands Trial Register: NL6281/NTR6455 . Registered 18 May 2017, https://www.trialregister.nl/trial/6281.",2020,Presence of circulating tumor DNA (ctDNA) is indicative for MRD and has high predictive value for recurrent disease.,"['Patients with colorectal cancer (CRC', 'patients who might benefit form adjuvant chemotherapy (ACT', 'patients with minimal residual disease (MRD) after surgery for stage II colon cancer (CC', '1320 stage II CC patients without indication for ACT according to current guidelines', 'stage II colon cancer (MEDOCC-CrEATE']","['NL6281/NTR6455 ', 'ACT', 'capecitabine plus oxaliplatin']","['5-year RR, disease free survival, overall survival, time to recurrence, quality of life and cost-effectiveness', 'proportion of patients receiving ACT', '2-year recurrence rate (RR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0278479', 'cui_str': 'Carcinoma of colon, stage II'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]",,0.206776,Presence of circulating tumor DNA (ctDNA) is indicative for MRD and has high predictive value for recurrent disease.,"[{'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Schraa', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'van Rooijen', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'D E W', 'Initials': 'DEW', 'LastName': 'van der Kruijssen', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rubio Alarcón', 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Phallen', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sausen', 'Affiliation': 'Personal Genome Diagnostics, Baltimore, MD, 21224, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Simmons', 'Affiliation': 'Personal Genome Diagnostics, Baltimore, MD, 21224, USA.'}, {'ForeName': 'V M H', 'Initials': 'VMH', 'LastName': 'Coupé', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Centers, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'W M U', 'Initials': 'WMU', 'LastName': 'van Grevenstein', 'Affiliation': 'Department of Surgical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Elias', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Verkooijen', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Laclé', 'Affiliation': 'Department of Pathology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'L J W', 'Initials': 'LJW', 'LastName': 'Bosch', 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'van den Broek', 'Affiliation': 'Department of Laboratory Medicine, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Meijer', 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'V E', 'Initials': 'VE', 'LastName': 'Velculescu', 'Affiliation': 'The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine, Baltimore, MD, 21287, USA.'}, {'ForeName': 'R J A', 'Initials': 'RJA', 'LastName': 'Fijneman', 'Affiliation': 'Department of Pathology, Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Vink', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Koopman', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Heidelberglaan 100, 3584 CX, Utrecht, The Netherlands. m.koopman-6@umcutrecht.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMC cancer,['10.1186/s12885-020-07252-y']
2634,32819393,The effects of varying doses of caffeine on cardiac parasympathetic reactivation following an acute bout of anaerobic exercise in recreational athletes.,"BACKGROUND


To examine the effects of varying doses of caffeine on autonomic reactivation following anaerobic exercise.
METHODS


Recreationally active males (N = 20; 24 ± 2y) participated in a randomized, double-blind, placebo-controlled, crossover study where participants ingested: [1] Control (CON; no supplement), [2] a non-caffeinated placebo (PLA), [3] 3-mg∙kg - 1  of caffeine (CAF3) or [4] 6-mg∙kg - 1  of caffeine (CAF6) prior to Wingate testing. Parasympathetic (lnRMSSD, primary outcome) and global HRV (lnSDNN, secondary outcome) were assessed at rest (i.e., pre-ingestion), 45-min post-ingestion, and 5-min and 35-min post-exercise recovery. We used a GLM to assess mean (95% CI) changes from pre-ingestion baseline.
RESULTS


Overall, we observed a significant trend for lnRMSSD and lnSDNN (both, p = 0.001, ηp 2  = 0.745). Forty-five minutes after treatment ingestion, we observed a significant increase in lnRMSSD for CAF3 (0.15 ms, 95%CI, 0.07,0.24) and CAF6 (0.16 ms, 95%CI, 0.06,0.25), both being significant (both, p <  0.004) vs. CON (- 0.02 ms, 95%CI, - 0.09,0.04). Five-minutes after exercise, all treatments demonstrated significant declines in lnRMSSD vs. baseline (all, p <  0.001). After 35-min of recovery, lnRMSSD returned to a level not significantly different than baseline for CAF3 (0.03 ms, 95%CI, - 0.05, 0.12) and CAF6 (- 0.03 ms, 95%CI, - 0.17, 0.10), while PLA (- 0.16 ms, 95%CI, - 0.25, - 0.06) and CON (- 0.17 ms, 95%CI, - 0.28, - 0.07) treatments remained significantly depressed. A similar pattern was also observed for SDNN.
CONCLUSION


Caffeine ingestion increases resting cardiac autonomic modulation and accelerates post-exercise autonomic recovery after a bout of anaerobic exercise in recreationally active young men. However, no differences between caffeine doses on cardiac autonomic reactivity were observed.",2020,"Five-minutes after exercise, all treatments demonstrated significant declines in lnRMSSD vs. baseline (all, p <  0.001).","['recreationally active young men', 'active males (N\u2009=\u200920; 24\u2009±\u20092y) participated', 'Recreationally', 'recreational athletes']","['caffeine (CAF6', 'caffeine', 'anaerobic exercise', 'ingested: [1] Control (CON; no supplement), [2] a non-caffeinated placebo (PLA), [3] 3-mg∙kg -\u20091  of caffeine (CAF3) or [4', 'Caffeine ingestion', 'placebo']","['cardiac parasympathetic reactivation', 'CAF3', 'autonomic reactivation', 'lnRMSSD for CAF3', 'CAF6', 'resting cardiac autonomic modulation and accelerates post-exercise autonomic recovery', 'Parasympathetic (lnRMSSD, primary outcome) and global HRV (lnSDNN, secondary outcome) were assessed at rest (i.e., pre-ingestion), 45-min post-ingestion, and 5-min and 35-min post-exercise recovery', 'CON', 'cardiac autonomic reactivity']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.499884,"Five-minutes after exercise, all treatments demonstrated significant declines in lnRMSSD vs. baseline (all, p <  0.001).","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Sarshin', 'Affiliation': 'Department of Exercise Physiology, Karaj Branch, Islamic Azad University, Karaj, Iran. amsarshin@gmail.com.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Naderi', 'Affiliation': 'Department of Sport Physiology, Boroujerd Branch, Islamic Azad University, Boroujerd, Iran.'}, {'ForeName': 'Carlos Janssen Gomes', 'Initials': 'CJG', 'LastName': 'da Cruz', 'Affiliation': 'Laboratory of Exercise Physiology, Faculty of Physical Education, University of Brasilia, Brasília, Brazil.'}, {'ForeName': 'Foad', 'Initials': 'F', 'LastName': 'Feizolahi', 'Affiliation': 'Department of Exercise Physiology, Karaj Branch, Islamic Azad University, Karaj, Iran.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Forbes', 'Affiliation': 'Faculty of Education, Department of Physical Education, Brandon University, Brandon, MB, R7A6A9, Canada.'}, {'ForeName': 'Darren G', 'Initials': 'DG', 'LastName': 'Candow', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, SK, S4S0A2, Canada.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Mohammadgholian', 'Affiliation': 'Department of Exercise Physiology, Karaj Branch, Islamic Azad University, Karaj, Iran.'}, {'ForeName': 'Mehrdad', 'Initials': 'M', 'LastName': 'Amiri', 'Affiliation': 'Department of Exercise Physiology, Karaj Branch, Islamic Azad University, Karaj, Iran.'}, {'ForeName': 'Naghmeh', 'Initials': 'N', 'LastName': 'Jafari', 'Affiliation': 'Department of Exercise Physiology, Karaj Branch, Islamic Azad University, Karaj, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Rahimi', 'Affiliation': 'Department of Exercise Physiology, Karaj Branch, Islamic Azad University, Karaj, Iran.'}, {'ForeName': 'Eidi', 'Initials': 'E', 'LastName': 'Alijani', 'Affiliation': 'Department of Exercise Physiology, Karaj Branch, Islamic Azad University, Karaj, Iran.'}, {'ForeName': 'Conrad P', 'Initials': 'CP', 'LastName': 'Earnest', 'Affiliation': 'Health and Kinesiology, Texas A & M University, College Station, TX, USA.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-00373-6']
2635,32819394,"Primary and secondary three-month outcomes of a cluster-randomized trial of home-based postpartum contraceptive delivery in southwest Trifinio, Guatemala.","DESIGN


This a cluster-randomized parallel arm pragmatic trial to observe the association of home-based postpartum contraceptive provision, including the contraceptive implant, with implant utilization rates at 3 months post-enrollment.
METHODS


In a region of rural Guatemala referred to as the Southwest Trifinio, twelve communities are served by a community-based antenatal and postnatal care program. The communities were combined into eight clusters based on 2017 birth rates and randomized to receive the home-based contraceptive delivery (condoms, pills, injection, implant) during the routine 40-day postpartum visit. All participants receive comprehensive contraceptive counseling beginning at the first antenatal visit, so control clusters received this as part of routine care; this education preceded the study intervention.
RESULTS


Once the 12 communities were combined into 8 clusters by expected birth volume and nurse team, which we expected to translate to eventual postpartum visits, the allocation sequence was generated in SAS. Of 208 women enrolled in the study, 108 were in four intervention and 100 in four control clusters. We used descriptive statistics to produce counts and percentages of characteristics of the study population overall and by intervention arm followed by univariate modeling using a mixed effects regression adjusted for cluster. Three-month contraceptive initiation rates were 56.0% in the control clusters compared to 76.8% in the intervention clusters, p < 0.001. Women in control clusters overwhelmingly opted for the injectable contraceptive (94.6%) while women in intervention clusters chose both the injection (61.5%) and the implant (33.7%), p < 0.001. Implant use by 3 months, the primary outcome of the study, was significantly higher in the intervention arm (25.9%) compared to the control arm (3.6%), p < 0.001, RR 1.3 CI [1.2, 1.4].
CONCLUSION


Our study was designed to respond to previously identified barriers to contraceptive uptake, and it was successful. Not only did it increase overall use of contraception by 3 months, but it shifted that contraceptive use away from short-acting methods in favor of longer-acting methods, with high continuation and satisfaction rates and no adverse outcomes reported.
TRIAL REGISTRATION


clinicaltrials.gov , NCT04005391 ; Retrospectively Registered 7/2/2019.",2020,"Three-month contraceptive initiation rates were 56.0% in the control clusters compared to 76.8% in the intervention clusters, p < 0.001.","['In a region of rural Guatemala referred to as the Southwest Trifinio, twelve communities are served by a community-based antenatal and postnatal care program', '208 women enrolled in the study, 108 were in four intervention and 100 in four control clusters']","['comprehensive contraceptive counseling', 'home-based contraceptive delivery (condoms, pills, injection, implant']",['contraceptive initiation rates'],"[{'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C1443484', 'cui_str': 'Contraception care education'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0021102', 'cui_str': 'Implant'}]","[{'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",208.0,0.0765249,"Three-month contraceptive initiation rates were 56.0% in the control clusters compared to 76.8% in the intervention clusters, p < 0.001.","[{'ForeName': 'Margo S', 'Initials': 'MS', 'LastName': 'Harrison', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA. margo.harrison@cuanschutz.edu.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Bunge-Montes', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Rivera', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jimenez-Zambrano', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA.'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Heinrichs', 'Affiliation': 'Denver Health, Denver, CO, USA.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bolanos', 'Affiliation': 'Fundación para la Salud Integral de los Guatemaltecos (FSIG), Quetzaltenango, Guatemala.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Asturias', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Berman', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA.'}, {'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Sheeder', 'Affiliation': 'University of Colorado, Anschutz Medical Campus, Mail Stop B198-2, Academic Office 1, 12631 E. 17th Avenue, Rm 4211, Aurora, CO, 80045, USA.'}]",Reproductive health,['10.1186/s12978-020-00974-z']
2636,32819399,"The CARDIA-trial protocol: a multinational, prospective, randomized, clinical trial comparing transthoracic esophagectomy with transhiatal extended gastrectomy in adenocarcinoma of the gastroesophageal junction (GEJ) type II.","BACKGROUND


Adenocarcinoma of the gastroesophageal junction (GEJ) Siewert type II can be resected by transthoracic esophagectomy or transhiatal extended gastrectomy. Both allow for a complete tumor resection, yet there is an ongoing controversy about which surgical approach is superior with regards to quality of life, oncological outcomes and survival. While some studies suggest a better oncological outcome after transthoracic esophagectomy, others favor transhiatal extended gastrectomy for a better postoperative quality of life. To date, only retrospective studies are available, showing ambiguous results.
METHODS


This study is a multinational, multicenter, randomized, clinical superiority trial. Patients (n = 262) with a GEJ type II tumor resectable by both transthoracic esophagectomy and transhiatal extended gastrectomy will be enrolled in the trial. Type II tumors are defined as tumors with their midpoint between ≤1 cm proximal and ≤ 2 cm distal of the top of gastric folds on preoperative endoscopy. Patients will be included in one of the participating European sites and are randomized to either transthoracic esophagectomy or transhiatal extended gastrectomy. The trial is powered to show superiority for esophagectomy with regards to the primary efficacy endpoint overall survival. Key secondary endpoints are complete resection (R0), number and localization of tumor infiltrated lymph nodes at dissection, post-operative complications, disease-free survival, quality of life and cost-effectiveness. Postoperative survival and quality of life will be followed-up for 24 months after discharge. Further survival follow-up will be conducted as quarterly phone calls up to 60 months.
DISCUSSION


To date, as level 1 evidence is lacking, there is no consensus on which surgery is superior and both surgeries are used to treat GEJ type II carcinoma worldwide. The CARDIA trial is the first randomized trial to compare transthoracic esophagectomy versus transhiatal extended gastrectomy in patients with GEJ type II tumors. Several quality control measures were implemented in the protocol to ensure data reliability and increase the trial's significance. It is hypothesized that esophagectomy allows for a higher rate of radical resections and a more complete mediastinal lymph node dissection, resulting in a longer overall survival, while still providing an acceptable quality of life and cost-effectiveness.
TRIAL REGISTRATION


The trial was registered on August 2nd 2019 at the German Clinical Trials Register under the trial-ID DRKS00016923 .",2020,The CARDIA trial is the first randomized trial to compare transthoracic esophagectomy versus transhiatal extended gastrectomy in patients with GEJ type II tumors.,"['Adenocarcinoma of the gastroesophageal junction (GEJ', 'Patients (n = 262) with a GEJ type II tumor resectable by both', 'in adenocarcinoma of the gastroesophageal junction (GEJ) type II', 'patients with GEJ type II tumors']","['transthoracic esophagectomy with transhiatal extended gastrectomy', 'transthoracic esophagectomy and transhiatal extended gastrectomy', 'transthoracic esophagectomy or transhiatal extended gastrectomy', 'transthoracic esophagectomy versus transhiatal extended gastrectomy']","['postoperative quality of life', 'complete resection (R0), number and localization of tumor infiltrated lymph nodes at dissection, post-operative complications, disease-free survival, quality of life and cost-effectiveness', 'Postoperative survival and quality of life']","[{'cui': 'C1332166', 'cui_str': 'Adenocarcinoma of the gastroesophageal junction'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0205503', 'cui_str': 'Transthoracic approach'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015250', 'cui_str': 'Complete excision'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",262.0,0.18429,The CARDIA trial is the first randomized trial to compare transthoracic esophagectomy versus transhiatal extended gastrectomy in patients with GEJ type II tumors.,"[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Leers', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Knepper', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany. laura.knepper@uk-koeln.de.'}, {'ForeName': 'Arjen', 'Initials': 'A', 'LastName': 'van der Veen', 'Affiliation': 'Department of Surgical Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Schröder', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Fuchs', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Schiller', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, University of Cologne, Robert-Koch-Str. 10, 50931, Cologne, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hellmich', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, University of Cologne, Robert-Koch-Str. 10, 50931, Cologne, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Zettelmeyer', 'Affiliation': 'Clinical Trials Centre Cologne, University of Cologne, Gleueler Str. 269, 50935, Cologne, Germany.'}, {'ForeName': 'Lodewijk A A', 'Initials': 'LAA', 'LastName': 'Brosens', 'Affiliation': 'Department of Pathology, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Quaas', 'Affiliation': 'Institute for Pathology, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}, {'ForeName': 'Jelle P', 'Initials': 'JP', 'LastName': 'Ruurda', 'Affiliation': 'Department of Surgical Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'van Hillegersberg', 'Affiliation': 'Department of Surgical Oncology, University Medical Center Utrecht, Heidelberglaan 100, 3584, CX, Utrecht, The Netherlands.'}, {'ForeName': 'Christiane J', 'Initials': 'CJ', 'LastName': 'Bruns', 'Affiliation': 'Department of General, Visceral, Cancer and Transplantation Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.'}]",BMC cancer,['10.1186/s12885-020-07152-1']
2637,32819439,"Effect of albumin administration on outcomes in hypoalbuminemic patients hospitalized with community-acquired pneumonia (ALBUCAP): a prospective, randomized, phase III clinical controlled trial-a trial protocol.","BACKGROUND


Community-acquired pneumonia (CAP) remains a leading cause of death worldwide, and hypoalbuminemia is associated with worse outcomes. However, it remains uncertain whether albumin administration could have any beneficial effects. We aim to assess whether the administration of albumin in hypoalbuminemic patients with CAP increases the proportion of clinically stable patients at day 5 compared with the standard of care alone.
METHODS


This is a trial protocol for a superiority, non-blinded, multicenter, randomized, phase 3, interventional controlled clinical trial. The primary endpoint will be the proportion of clinical stable patients at day 5 (intention to treat), defined as those with stable vital signs for at least 24 h. The secondary endpoints will be time to clinical stability, duration of intravenous and total antibiotic treatment, length of hospital stay, intensive care unit admission, duration of mechanical ventilation and vasopressor treatment, adverse events, readmission within 30 days, and all-cause mortality. The trial has been approved by the Spanish Medicines and Healthcare Products Regulatory Agency. The investigators commit to publish the data in peer-reviewed journals within a year of the study completion date. Subjects will be recruited from three Spanish hospitals over a planned enrolment period of 2 years. A follow-up visit will be performed 1 month after discharge. We have estimated the need for a sample size of 360 patients at a two-sided 5% alpha-level with a power of 80% based on intention to treat. Eligible participants must be hospitalized, hypoalbuminemic (≤ 30 g/L), non-immunosuppressed, adults, and diagnosed with CAP. They will be randomly assigned (1:1) to receive standard care plus albumin (20 g in 100 mL) every 12 h for 4 days or standard care alone.
DISCUSSION


If this randomized trial confirms the hypothesis, it should lead to a change in current clinical practice for the management of hypoalbuminemic patients with CAP.
TRIAL REGISTRATION


European Clinical Trials Database (EudraCT) 2018-003117-18 . Registered on 12 April 2019. ClinicalTrials.gov NCT04071041 . Registered on 27 August 2019.",2020,"We aim to assess whether the administration of albumin in hypoalbuminemic patients with CAP increases the proportion of clinically stable patients at day 5 compared with the standard of care alone.
","['Eligible participants must be hospitalized, hypoalbuminemic (≤\u200930\u2009g/L), non-immunosuppressed, adults, and diagnosed with CAP', 'hypoalbuminemic patients with CAP increases the proportion of clinically stable patients at day 5 compared with the standard of care alone', 'Subjects will be recruited from three Spanish hospitals over a planned enrolment period of 2\xa0years', 'hypoalbuminemic patients with CAP', '360 patients at a two-sided 5% alpha-level with a power of 80% based on intention to treat', 'hypoalbuminemic patients hospitalized with community-acquired pneumonia (ALBUCAP']","['standard care plus albumin', 'albumin administration', 'albumin']","['time to clinical stability, duration of intravenous and total antibiotic treatment, length of hospital stay, intensive care unit admission, duration of mechanical ventilation and vasopressor treatment, adverse events, readmission within 30\u2009days, and all-cause mortality', 'proportion of clinical stable patients at day 5 (intention to treat), defined as those with stable vital signs']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C1293861', 'cui_str': 'Administration of albumin'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",,0.313588,"We aim to assess whether the administration of albumin in hypoalbuminemic patients with CAP increases the proportion of clinically stable patients at day 5 compared with the standard of care alone.
","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rombauts', 'Affiliation': ""Department of Infectious Disease, Hospital Universitari de Bellvitge-Bellvitge Biomedical Research Institute (IDIBELL), Carrer de la Feixa Llarga, s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain. alexander.rombauts@gmail.com.""}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Abelenda-Alonso', 'Affiliation': ""Department of Infectious Disease, Hospital Universitari de Bellvitge-Bellvitge Biomedical Research Institute (IDIBELL), Carrer de la Feixa Llarga, s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.""}, {'ForeName': 'Antonella Francesca', 'Initials': 'AF', 'LastName': 'Simonetti', 'Affiliation': 'Department of Internal Medicine, Hospital Residència Sant Camil-Consorci Sanitari del Garraf, Sant Pere de Ribes, Barcelona, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Verdejo', 'Affiliation': 'Department of Internal Medicine, Hospital Residència Sant Camil-Consorci Sanitari del Garraf, Sant Pere de Ribes, Barcelona, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Meije', 'Affiliation': ""Infectious Diseases Unit - Internal Medicine Department, Hospital de Barcelona, Societat Cooperativa d'Instal·lacions Assistencials Sanitàries (SCIAS), Barcelona, Spain.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Ortega', 'Affiliation': ""Infectious Diseases Unit - Internal Medicine Department, Hospital de Barcelona, Societat Cooperativa d'Instal·lacions Assistencials Sanitàries (SCIAS), Barcelona, Spain.""}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Clemente', 'Affiliation': ""Infectious Diseases Unit - Internal Medicine Department, Hospital de Barcelona, Societat Cooperativa d'Instal·lacions Assistencials Sanitàries (SCIAS), Barcelona, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Niubó', 'Affiliation': 'Department of Microbiology, Hospital Universitari de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Ruiz', 'Affiliation': 'Department of Pneumology, Hospital Universitari de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Gudiol', 'Affiliation': ""Department of Infectious Disease, Hospital Universitari de Bellvitge-Bellvitge Biomedical Research Institute (IDIBELL), Carrer de la Feixa Llarga, s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.""}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Tebé', 'Affiliation': 'Biostatistic Unit at IDIBELL, Barcelona, Spain.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Videla', 'Affiliation': 'Department of Clinical Pharmacology, Hospital Universitari de Bellvitge, Hospital de Llobregat, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Carratalà', 'Affiliation': ""Department of Infectious Disease, Hospital Universitari de Bellvitge-Bellvitge Biomedical Research Institute (IDIBELL), Carrer de la Feixa Llarga, s/n, L'Hospitalet de Llobregat, 08907, Barcelona, Spain.""}]",Trials,['10.1186/s13063-020-04627-1']
2638,32819441,The effect of ear acupressure (auriculotherapy) on sexual function of lactating women: protocol of a randomized sham controlled trial.,"BACKGROUND


Lactation has a negative effect on female sexual function. Hormonal changes during lactation cause changes which might lead to dyspareunia, lack of libido, and anorgasmia. There are various pharmacological and non-pharmacological approaches to treat sexual dysfunction. While pharmacological treatment has multiple unwanted side effects, non-pharmacological therapies such as complementary medicine are a potential safer alternative. The aim of this study is to evaluate the effect of ear acupressure on sexual function of lactating women.
METHODS/DESIGN


This is a randomized clinical trial with a parallel sham control group. In this study, 76 lactating women between 6 months and 1 year after childbirth were referred to health care centers in Qazvin City and would be invited to participate. Participants will be divided into intervention (n = 38) and control (n = 38) groups using simple block randomization. Both intervention and sham control groups will be visited over 10 sessions within a 4-day interval. At each visit, the adhesives containing Vaccaria seed will be adhered for the intervention group, while non-latex-based adhesives with no Vaccaria seeds will be placed on the same ear acupoints for the sham control group. Selected ear acupoints include genitalia (two ear points), pelvic point, master shoulder, and posterior pituitary gland. The women will be asked to hold the seeds on their ears for 3 days and press each ear point three times a day for 20 s. After 3 days, they will be asked to remove the seeds from their ears and rest for 1 day. Sexual function as primary outcome in both groups will be assessed using the Female Sexual Function Index before and immediately after 1 and 2 months after the intervention. Also, Sexual Quality of Life as secondary outcome will be assessed using Sexual Quality of Life-Female (SQOL-F) before and 2 months after intervention. Data will be analyzed using repeated measure ANOVA at the significant level of 0.05.
DISCUSSION


This study is expected to support the impact of ear channel ear acupressure on sexual function in lactating women.
TRIAL REGISTRATION


Iranian Clinical Trial Registration Center IRCT20190626044028N1 . Registered on 16 August 2019.",2020,Sexual function as primary outcome in both groups will be assessed using the Female Sexual Function Index before and immediately after 1 and 2 months after the intervention.,"['76 lactating women between 6\u2009months and 1\xa0year after childbirth were referred to health care centers in Qazvin City and would be invited to participate', 'lactating women']","['ear acupressure', 'ear acupressure (auriculotherapy', 'channel ear acupressure']","['Female Sexual Function Index', 'Sexual Quality of Life-Female (SQOL-F', 'sexual function', 'Sexual Quality of Life', 'Sexual function']","[{'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C2350276', 'cui_str': 'Auriculotherapy'}, {'cui': 'C0439799', 'cui_str': 'Channel'}]","[{'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]",76.0,0.124762,Sexual function as primary outcome in both groups will be assessed using the Female Sexual Function Index before and immediately after 1 and 2 months after the intervention.,"[{'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Barghamadi', 'Affiliation': 'Student Research Committee, Qazvin University of Medical Sciences, Qazvin, Iran.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Alimoardi', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin, Iran.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Oleson', 'Affiliation': ""Emperor's College of Traditional Oriental Medicine, Santa Monica, CA, USA.""}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Bahrami', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Prevention of Non-Communicable Diseases, Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Qazvin, Iran. nbahrami@qums.ac.ir.'}]",Trials,['10.1186/s13063-020-04663-x']
2639,32819444,"Comparison of McGrath, Pentax, and Macintosh laryngoscope in normal and cervical immobilized manikin by novices: a randomized crossover trial.","BACKGROUND


The aim of this study was to compare tracheal intubation performance regarding the time to intubation, glottic view, difficulty, and dental click, by novices using McGrath videolaryngoscope (VL), Pentax Airway Scope (AWS) and Macintosh laryngoscope in normal and cervical immobilized manikin models.
METHODS


Thirty-five anesthesia nurses without previous intubation experience were recruited. Participants performed endotracheal intubation in a manikin model at two simulated neck positions (normal and fixed neck via cervical immobilization), using three different devices three times each. Performance parameters included intubation time, success rate of intubation, Cormack Lehane laryngoscope grading, dental click, and subjective difficulty score.
RESULTS


Intubation time and success rate during first attempt were not significantly different between the 3 groups in normal airway manikin. In the cervical immobilized manikin, the intubation time was shorter (p = 0.012), and the success rate with the first attempt was significantly higher (p < 0.001) when using McGrath VL and Pentax AWS compared with Macintosh laryngoscope. Both VLs showed less difficulty score (p < 0.001) and more Cormack Lehane grade I (p < 0.001) in both scenarios. The incidence of dental clicks was higher with Macintosh laryngoscope compared with McGrath VL in cervical immobilized airway (p < 0.001).
CONCLUSIONS


McGrath VL and Pentax AWS did not show clinically significant decrease in intubation time, however, they achieved higher first attempt success rate, easier intubation and better glottis view compared with Macintosh laryngoscope by novices in a cervical immobilized manikin model. McGrath VL may reduce the risk of dental injury compared with Macintosh laryngoscope in cervical immobilized scenario.
TRIAL REGISTRATION


ClinicalTrials.gov (NCT03161730), May 22, 2017 https://clinicaltrials.gov/ct2/hom.",2020,"RESULTS


Intubation time and success rate during first attempt were not significantly different between the 3 groups in normal airway manikin.","['Thirty-five anesthesia', 'nurses without previous intubation experience were recruited', 'normal and cervical immobilized manikin by novices']","['McGrath, Pentax, and Macintosh laryngoscope', 'McGrath videolaryngoscope (VL), Pentax Airway Scope (AWS) and Macintosh laryngoscope', 'endotracheal intubation']","['incidence of dental clicks', 'difficulty score', 'tracheal intubation performance', 'intubation time, success rate of intubation, Cormack Lehane laryngoscope grading, dental click, and subjective difficulty score', 'intubation time', 'Intubation time and success rate', 'success rate']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}]","[{'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}]",35.0,0.17611,"RESULTS


Intubation time and success rate during first attempt were not significantly different between the 3 groups in normal airway manikin.","[{'ForeName': 'In Kyong', 'Initials': 'IK', 'LastName': 'Yi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, Korea.'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Kwak', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, 24, Namdong-Daero 774beon-gil, Namdong-gu, Incheon, 21565, Korea.'}, {'ForeName': 'Kyung Cheon', 'Initials': 'KC', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Gachon University, Gil Medical Center, 24, Namdong-Daero 774beon-gil, Namdong-gu, Incheon, 21565, Korea.'}, {'ForeName': 'Ji Hyea', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, Korea.'}, {'ForeName': 'Sang Kee', 'Initials': 'SK', 'LastName': 'Min', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, Korea.'}, {'ForeName': 'Jong Yeop', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine, 164, World cup-ro, Yeongtong-gu, Suwon, 16499, Korea. kjyeop@ajou.ac.kr.'}]",European journal of medical research,['10.1186/s40001-020-00435-0']
2640,32819445,Combined use of intravenous and topical tranexamic acid efficiently reduces blood loss in patients aged over 60 operated with a 2-level lumbar fusion.,"PURPOSE


The current study was conducted to assess the efficacy and safety of the intravenous (IV) administration combined with topical administration of tranexamic acid (TXA)in patients (aged over 60) scheduled for a 2-level lumbar fusion surgery.
METHODS


Two hundred eighty patients scheduled for a 2-level lumbar fusion surgery were randomized into four groups, including an IV group, a local group, a combined group, and a control group. Patients in the combined group, in the IV group, in the topical group, and in the control group were administrated with 15 mg/kg of IV-TXA + 2 g TXA in local, 15 mg/kg IV-TXA, 2 g TXA in local, and 100 ml IV, respectively. The results of total blood loss (TBL), maximum hemoglobin drop, the transfusion rate, and the number of allogeneic blood units were compared. Deep venous thrombosis (DVT) and pulmonary embolism (PE) events were monitored and recorded.
RESULTS


The TBL was 635.49 ± 143.60, 892.62 ± 166.85, 901.11 ± 186.25, and 1225.11 ± 186.25 mL for the combined group, the IV group, the topical group, and the control group, respectively (p = 0.015, p = 0.001, respectively). The average maximum hemoglobin drop in the four above groups was 2.18 ± 0.24, 2.80 ± 0.37, 2.40 ± 0.64, and 3.40 ± 1.32 g/dL, respectively. No PE event was reported during the follow-up. Although asymptomatic DVT events were reported by 1, 2, and 2 patients in the combined group, topical group, and control group, respectively, there is no intergroup difference.
CONCLUSIONS


The combined use of TXA effectively reduced the total blood loss and blood transfusion rate in patients aged over 60 scheduled for a 2-level lumbar fusion, without increasing the incidence of DVT and PE formation.",2020,"The combined use of TXA effectively reduced the total blood loss and blood transfusion rate in patients aged over 60 scheduled for a 2-level lumbar fusion, without increasing the incidence of DVT and PE formation.","['Two hundred eighty patients scheduled for a 2-level lumbar fusion surgery', 'patients (aged over 60) scheduled for a 2-level lumbar fusion surgery', 'patients aged over 60 operated with a 2-level lumbar fusion', 'patients aged over 60 scheduled for a 2-level lumbar fusion']","['intravenous and topical tranexamic acid', 'TXA', 'tranexamic acid (TXA)in', '15\u2009mg/kg of IV-TXA + 2\u2009g TXA']","['total blood loss and blood transfusion rate', 'total blood loss (TBL), maximum hemoglobin drop, the transfusion rate, and the number of allogeneic blood units', 'average maximum hemoglobin', 'efficacy and safety', 'Deep venous thrombosis (DVT) and pulmonary embolism (PE) events', 'incidence of DVT and PE formation', 'asymptomatic DVT events', 'blood loss']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0232100', 'cui_str': 'Exsanguination'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0439184', 'cui_str': 'Units of blood'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",280.0,0.0717007,"The combined use of TXA effectively reduced the total blood loss and blood transfusion rate in patients aged over 60 scheduled for a 2-level lumbar fusion, without increasing the incidence of DVT and PE formation.","[{'ForeName': 'Jianjiang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedic Surgery, Traditional Chinese Medicine Hospital of Xinjiang Medical University, Urumqi, Xinjiang, 830000, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Orthopedic Surgery, Traditional Chinese Medicine Hospital of Xinjiang Medical University, Urumqi, Xinjiang, 830000, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Bai', 'Affiliation': 'Department of Orthopedic Surgery, Traditional Chinese Medicine Hospital of Xinjiang Medical University, Urumqi, Xinjiang, 830000, China.'}, {'ForeName': 'Yanlu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedic Surgery, Traditional Chinese Medicine Hospital of Xinjiang Medical University, Urumqi, Xinjiang, 830000, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Orthopedic Surgery, Traditional Chinese Medicine Hospital of Xinjiang Medical University, Urumqi, Xinjiang, 830000, China. drhuangyifei@163.com.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01758-8']
2641,32813842,Evaluation of reservoirs in bleaching trays for at-home bleaching: a split-mouth single-blind randomized controlled equivalence trial.,"Objectives This randomized, split-mouth, single-blinded trial assessed whether the use of reservoirs in at-home bleaching trays is equivalent to non-reservoir trays. Our choice of an equivalence trial was based on the expectation that a non-reservoir tray is sufficient to produce a color change. Secondary outcomes such as tooth sensitivity (TS) and gingival irritation (GI) were also assessed. Methodology Forty-six patients were selected with canines shade A2 or darker. In half of the patient's arch, bleaching trays were made with reservoirs and the other half, without reservoirs. At-home bleaching was performed with carbamide peroxide (CP) 10% (3 h daily; 21 days). Color change was evaluated with a digital spectrophotometer (ΔE, ΔE00, and Whiteness Index) and shade guide units (ΔSGU) at baseline, during and one-month post-bleaching. TS and GI were assessed with a numeric scale (NRS) and a visual analog scale (VAS). Results After one month, the equivalence of reservoir and non-reservoir groups were observed in all color instruments (p>0.05). Fifteen and sixteen patients presented pain (absolute risk: 33% and 35%, 95%, confidence interval (CI) 21-46% and 23-49%) in the reservoir and non-reservoir side, respectively. The odds ratio for pain was 0.8 (95%CI 0.2-3.0) and the p-value was non-significant (p=1.0). TS intensity was similar between both groups in any of the pain scales (p>0.05). No difference in the GI was observed (p>0.05). Conclusions The protocol with reservoirs is equivalent in color change to the non-reservoir, although no superiority of the latter was observed in terms of reduced TS and GI with at-home 10% carbamide peroxide bleaching. Clinical Relevance The presence of reservoirs in a bleaching tray did not improve color change or affect tooth sensitivity and gingival irritation.",2020,"The protocol with reservoirs is equivalent in color change to the non-reservoir, although no superiority of the latter was observed in terms of reduced TS and GI with at-home 10% carbamide peroxide bleaching.",['Methodology Forty-six patients were selected with canines shade A2 or darker'],['carbamide peroxide (CP'],"['digital spectrophotometer (ΔE, ΔE00, and Whiteness Index) and shade guide units (ΔSGU', 'color change or affect tooth sensitivity and gingival irritation', 'tooth sensitivity (TS) and gingival irritation (GI', 'numeric scale (NRS) and a visual analog scale (VAS', 'TS intensity', 'GI', 'pain', 'odds ratio for pain']","[{'cui': 'C0969625', 'cui_str': 'methodology'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}]","[{'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0475330', 'cui_str': 'Color change'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}]",46.0,0.0970237,"The protocol with reservoirs is equivalent in color change to the non-reservoir, although no superiority of the latter was observed in terms of reduced TS and GI with at-home 10% carbamide peroxide bleaching.","[{'ForeName': 'Eveline Claudia', 'Initials': 'EC', 'LastName': 'Martini', 'Affiliation': 'Departamento de Dentística Restauradora, Universidade Estadual de Ponta Grossa, Ponta Grossa, Paraná, Brasil.'}, {'ForeName': 'Michael Willian', 'Initials': 'MW', 'LastName': 'Favoreto', 'Affiliation': 'Departamento de Dentística Restauradora, Universidade Estadual de Ponta Grossa, Ponta Grossa, Paraná, Brasil.'}, {'ForeName': 'Fabiana Madalozzo', 'Initials': 'FM', 'LastName': 'Coppla', 'Affiliation': 'Departamento de Dentística Restauradora, Centro de Ensino Superior dos Campos Gerais, Ponta Grossa, Paraná, Brasil.'}, {'ForeName': 'Alessandro Dourado', 'Initials': 'AD', 'LastName': 'Loguercio', 'Affiliation': 'Departamento de Dentística Restauradora, Universidade Estadual de Ponta Grossa, Ponta Grossa, Paraná, Brasil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Reis', 'Affiliation': 'Departamento de Dentística Restauradora, Universidade Estadual de Ponta Grossa, Ponta Grossa, Paraná, Brasil.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2020-0332']
2642,32813861,"High-saturated fatty meals with orange juice intake have subjective appetite sensations suppressed: Acute, postprandial study.","OBJECTIVE


To elucidate the acute effect of different high-fat meals accompanied by water or orange juice on subjective appetite sensations.
METHODS


This acute, postprandial study included 39 healthy women (aged 20 to 40 years): 22 participants received a high-monounsaturated fat meal (MUFA) (≈1000 kcal, 56.3% Energy from MUFA) and 17 participants received a high-saturated fat meal (SFA) (≈1000 kcal, 37.6% Energy from SFA). Both interventions were accompanied by 500 ml of water or orange juice. The subjective appetite sensations were evaluated before (fasting) and 1, 2, 3, 4, and 5 hours after the meal intake using the visual analog scale.
RESULTS


The subjective area under curve (AUC) appetite sensations and AUC appetite scores were equal after the consumption of high-fat meals from SFA and MUFA. Moreover, the consumption of a high-SFA meal raises the prospective desire to eat something fatty. In addition, the high-SFA meal consumption reduces subjective AUC appetite sensations and AUC appetite scores along the time, compared to a high-MUFA meal, when orange juice consumption followed those meals.
CONCLUSION


Our results demonstrate that high-MUFA meal consumption decreased the desire to intake something fatty, and the high-SFA meal, when followed by orange juice intake, has postprandial appetite sensations suppressed.",2020,The subjective area under curve (AUC) appetite sensations and AUC appetite scores were equal after the consumption of high-fat meals from SFA and MUFA.,['39 healthy women (aged 20 to 40 years): 22 participants received a'],"['high-monounsaturated fat meal (MUFA) (≈1000 kcal, 56.3% Energy from MUFA', 'high-saturated fat meal (SFA', 'high-fat meals accompanied by water or orange juice', 'High-saturated fatty meals with orange juice intake']","['postprandial appetite sensations', 'subjective AUC appetite sensations and AUC appetite scores', 'subjective appetite sensations', 'subjective area under curve (AUC) appetite sensations and AUC appetite scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0015687', 'cui_str': 'Monounsaturated fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",39.0,0.020711,The subjective area under curve (AUC) appetite sensations and AUC appetite scores were equal after the consumption of high-fat meals from SFA and MUFA.,"[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'DA Silva', 'Affiliation': 'Departamento de Nutrição e Saúde, Universidade Federal de Viçosa, Viçosa, MG, Brazil.'}, {'ForeName': 'Daniela Mayumi U P', 'Initials': 'DMUP', 'LastName': 'Rocha', 'Affiliation': 'Departamento de Nutrição e Saúde, Universidade Federal de Viçosa, Viçosa, MG, Brazil.'}, {'ForeName': 'LÍlian L', 'Initials': 'LL', 'LastName': 'Lopes', 'Affiliation': 'Departamento de Nutrição e Saúde, Universidade Federal de Viçosa, Viçosa, MG, Brazil.'}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Bressan', 'Affiliation': 'Departamento de Nutrição e Saúde, Universidade Federal de Viçosa, Viçosa, MG, Brazil.'}, {'ForeName': 'Helen Hermana M', 'Initials': 'HHM', 'LastName': 'Hermsdorff', 'Affiliation': 'Departamento de Nutrição e Saúde, Universidade Federal de Viçosa, Viçosa, MG, Brazil.'}]",Anais da Academia Brasileira de Ciencias,['10.1590/0001-3765202020191085']
2643,32813948,Effects of Diet versus Gastric Bypass on Metabolic Function in Diabetes.,"BACKGROUND


Some studies have suggested that in people with type 2 diabetes, Roux-en-Y gastric bypass has therapeutic effects on metabolic function that are independent of weight loss.
METHODS


We evaluated metabolic regulators of glucose homeostasis before and after matched (approximately 18%) weight loss induced by gastric bypass (surgery group) or diet alone (diet group) in 22 patients with obesity and diabetes. The primary outcome was the change in hepatic insulin sensitivity, assessed by infusion of insulin at low rates (stages 1 and 2 of a 3-stage hyperinsulinemic euglycemic pancreatic clamp). Secondary outcomes were changes in muscle insulin sensitivity, beta-cell function, and 24-hour plasma glucose and insulin profiles.
RESULTS


Weight loss was associated with increases in mean suppression of glucose production from baseline, by 7.04 μmol per kilogram of fat-free mass per minute (95% confidence interval [CI], 4.74 to 9.33) in the diet group and by 7.02 μmol per kilogram of fat-free mass per minute (95% CI, 3.21 to 10.84) in the surgery group during clamp stage 1, and by 5.39 (95% CI, 2.44 to 8.34) and 5.37 (95% CI, 2.41 to 8.33) μmol per kilogram of fat-free mass per minute in the two groups, respectively, during clamp stage 2; there were no significant differences between the groups. Weight loss was associated with increased insulin-stimulated glucose disposal, from 30.5±15.9 to 61.6±13.0 μmol per kilogram of fat-free mass per minute in the diet group and from 29.4±12.6 to 54.5±10.4 μmol per kilogram of fat-free mass per minute in the surgery group; there was no significant difference between the groups. Weight loss increased beta-cell function (insulin secretion relative to insulin sensitivity) by 1.83 units (95% CI, 1.22 to 2.44) in the diet group and by 1.11 units (95% CI, 0.08 to 2.15) in the surgery group, with no significant difference between the groups, and it decreased the areas under the curve for 24-hour plasma glucose and insulin levels in both groups, with no significant difference between the groups. No major complications occurred in either group.
CONCLUSIONS


In this study involving patients with obesity and type 2 diabetes, the metabolic benefits of gastric bypass surgery and diet were similar and were apparently related to weight loss itself, with no evident clinically important effects independent of weight loss. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT02207777.).",2020,"Weight loss increased beta-cell function (insulin secretion relative to insulin sensitivity) by 1.83 units (95% CI, 1.22 to 2.44) in the diet group and by 1.11 units (95% CI, 0.08 to 2.15) in the surgery group, with no significant difference between the groups, and it decreased the areas under the curve for 24-hour plasma glucose and insulin levels in both groups, with no significant difference between the groups.","['Diabetes', 'patients with obesity and type 2 diabetes', '22 patients with obesity and diabetes']","['Diet versus Gastric Bypass', 'gastric bypass (surgery group) or diet alone (diet group']","['Weight loss', 'Weight loss increased beta-cell function (insulin secretion relative to insulin sensitivity', 'mean suppression of glucose production', 'weight loss', 'major complications', 'change in hepatic insulin sensitivity, assessed by infusion of insulin at low rates (stages 1 and 2 of a 3-stage hyperinsulinemic euglycemic pancreatic clamp', '24-hour plasma glucose and insulin levels', 'Metabolic Function', 'changes in muscle insulin sensitivity, beta-cell function, and 24-hour plasma glucose and insulin profiles']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",22.0,0.0475783,"Weight loss increased beta-cell function (insulin secretion relative to insulin sensitivity) by 1.83 units (95% CI, 1.22 to 2.44) in the diet group and by 1.11 units (95% CI, 0.08 to 2.15) in the surgery group, with no significant difference between the groups, and it decreased the areas under the curve for 24-hour plasma glucose and insulin levels in both groups, with no significant difference between the groups.","[{'ForeName': 'Mihoko', 'Initials': 'M', 'LastName': 'Yoshino', 'Affiliation': 'From the Center for Human Nutrition (M.Y., B.D.K., J.Y., R.I.S., D.R., K.S., B.W.P., S.K.) and the Department of Surgery (J.C.E., S.R.E.), Washington University School of Medicine, St. Louis; and the Departments of Medicine (J.D.W., M.J.), Pharmacology (J.D.W., M.J.), Pediatrics (R.K.), and Computer Science and Engineering (R.K.), University of California San Diego, San Diego.'}, {'ForeName': 'Brandon D', 'Initials': 'BD', 'LastName': 'Kayser', 'Affiliation': 'From the Center for Human Nutrition (M.Y., B.D.K., J.Y., R.I.S., D.R., K.S., B.W.P., S.K.) and the Department of Surgery (J.C.E., S.R.E.), Washington University School of Medicine, St. Louis; and the Departments of Medicine (J.D.W., M.J.), Pharmacology (J.D.W., M.J.), Pediatrics (R.K.), and Computer Science and Engineering (R.K.), University of California San Diego, San Diego.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yoshino', 'Affiliation': 'From the Center for Human Nutrition (M.Y., B.D.K., J.Y., R.I.S., D.R., K.S., B.W.P., S.K.) and the Department of Surgery (J.C.E., S.R.E.), Washington University School of Medicine, St. Louis; and the Departments of Medicine (J.D.W., M.J.), Pharmacology (J.D.W., M.J.), Pediatrics (R.K.), and Computer Science and Engineering (R.K.), University of California San Diego, San Diego.'}, {'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Stein', 'Affiliation': 'From the Center for Human Nutrition (M.Y., B.D.K., J.Y., R.I.S., D.R., K.S., B.W.P., S.K.) and the Department of Surgery (J.C.E., S.R.E.), Washington University School of Medicine, St. Louis; and the Departments of Medicine (J.D.W., M.J.), Pharmacology (J.D.W., M.J.), Pediatrics (R.K.), and Computer Science and Engineering (R.K.), University of California San Diego, San Diego.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Reeds', 'Affiliation': 'From the Center for Human Nutrition (M.Y., B.D.K., J.Y., R.I.S., D.R., K.S., B.W.P., S.K.) and the Department of Surgery (J.C.E., S.R.E.), Washington University School of Medicine, St. Louis; and the Departments of Medicine (J.D.W., M.J.), Pharmacology (J.D.W., M.J.), Pediatrics (R.K.), and Computer Science and Engineering (R.K.), University of California San Diego, San Diego.'}, {'ForeName': 'J Christopher', 'Initials': 'JC', 'LastName': 'Eagon', 'Affiliation': 'From the Center for Human Nutrition (M.Y., B.D.K., J.Y., R.I.S., D.R., K.S., B.W.P., S.K.) and the Department of Surgery (J.C.E., S.R.E.), Washington University School of Medicine, St. Louis; and the Departments of Medicine (J.D.W., M.J.), Pharmacology (J.D.W., M.J.), Pediatrics (R.K.), and Computer Science and Engineering (R.K.), University of California San Diego, San Diego.'}, {'ForeName': 'Shaina R', 'Initials': 'SR', 'LastName': 'Eckhouse', 'Affiliation': 'From the Center for Human Nutrition (M.Y., B.D.K., J.Y., R.I.S., D.R., K.S., B.W.P., S.K.) and the Department of Surgery (J.C.E., S.R.E.), Washington University School of Medicine, St. Louis; and the Departments of Medicine (J.D.W., M.J.), Pharmacology (J.D.W., M.J.), Pediatrics (R.K.), and Computer Science and Engineering (R.K.), University of California San Diego, San Diego.'}, {'ForeName': 'Jeramie D', 'Initials': 'JD', 'LastName': 'Watrous', 'Affiliation': 'From the Center for Human Nutrition (M.Y., B.D.K., J.Y., R.I.S., D.R., K.S., B.W.P., S.K.) and the Department of Surgery (J.C.E., S.R.E.), Washington University School of Medicine, St. Louis; and the Departments of Medicine (J.D.W., M.J.), Pharmacology (J.D.W., M.J.), Pediatrics (R.K.), and Computer Science and Engineering (R.K.), University of California San Diego, San Diego.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Jain', 'Affiliation': 'From the Center for Human Nutrition (M.Y., B.D.K., J.Y., R.I.S., D.R., K.S., B.W.P., S.K.) and the Department of Surgery (J.C.E., S.R.E.), Washington University School of Medicine, St. Louis; and the Departments of Medicine (J.D.W., M.J.), Pharmacology (J.D.W., M.J.), Pediatrics (R.K.), and Computer Science and Engineering (R.K.), University of California San Diego, San Diego.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'From the Center for Human Nutrition (M.Y., B.D.K., J.Y., R.I.S., D.R., K.S., B.W.P., S.K.) and the Department of Surgery (J.C.E., S.R.E.), Washington University School of Medicine, St. Louis; and the Departments of Medicine (J.D.W., M.J.), Pharmacology (J.D.W., M.J.), Pediatrics (R.K.), and Computer Science and Engineering (R.K.), University of California San Diego, San Diego.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Schechtman', 'Affiliation': 'From the Center for Human Nutrition (M.Y., B.D.K., J.Y., R.I.S., D.R., K.S., B.W.P., S.K.) and the Department of Surgery (J.C.E., S.R.E.), Washington University School of Medicine, St. Louis; and the Departments of Medicine (J.D.W., M.J.), Pharmacology (J.D.W., M.J.), Pediatrics (R.K.), and Computer Science and Engineering (R.K.), University of California San Diego, San Diego.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'From the Center for Human Nutrition (M.Y., B.D.K., J.Y., R.I.S., D.R., K.S., B.W.P., S.K.) and the Department of Surgery (J.C.E., S.R.E.), Washington University School of Medicine, St. Louis; and the Departments of Medicine (J.D.W., M.J.), Pharmacology (J.D.W., M.J.), Pediatrics (R.K.), and Computer Science and Engineering (R.K.), University of California San Diego, San Diego.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'From the Center for Human Nutrition (M.Y., B.D.K., J.Y., R.I.S., D.R., K.S., B.W.P., S.K.) and the Department of Surgery (J.C.E., S.R.E.), Washington University School of Medicine, St. Louis; and the Departments of Medicine (J.D.W., M.J.), Pharmacology (J.D.W., M.J.), Pediatrics (R.K.), and Computer Science and Engineering (R.K.), University of California San Diego, San Diego.'}]",The New England journal of medicine,['10.1056/NEJMoa2003697']
2644,32813947,Evinacumab for Homozygous Familial Hypercholesterolemia.,"BACKGROUND


Homozygous familial hypercholesterolemia is characterized by premature cardiovascular disease caused by markedly elevated levels of low-density lipoprotein (LDL) cholesterol. This disorder is associated with genetic variants that result in virtually absent (null-null) or impaired (non-null) LDL-receptor activity. Loss-of-function variants in the gene encoding angiopoietin-like 3 ( ANGPTL3 ) are associated with hypolipidemia and protection against atherosclerotic cardiovascular disease. Evinacumab, a monoclonal antibody against ANGPTL3, has shown potential benefit in patients with homozygous familial hypercholesterolemia.
METHODS


In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned in a 2:1 ratio 65 patients with homozygous familial hypercholesterolemia who were receiving stable lipid-lowering therapy to receive an intravenous infusion of evinacumab (at a dose of 15 mg per kilogram of body weight) every 4 weeks or placebo. The primary outcome was the percent change from baseline in the LDL cholesterol level at week 24.
RESULTS


The mean baseline LDL cholesterol level in the two groups was 255.1 mg per deciliter, despite the receipt of maximum doses of background lipid-lowering therapy. At week 24, patients in the evinacumab group had a relative reduction from baseline in the LDL cholesterol level of 47.1%, as compared with an increase of 1.9% in the placebo group, for a between-group least-squares mean difference of -49.0 percentage points (95% confidence interval [CI], -65.0 to -33.1; P<0.001); the between-group least-squares mean absolute difference in the LDL cholesterol level was -132.1 mg per deciliter (95% CI, -175.3 to -88.9; P<0.001). The LDL cholesterol level was lower in the evinacumab group than in the placebo group in patients with null-null variants (-43.4% vs. +16.2%) and in those with non-null variants (-49.1% vs. -3.8%). Adverse events were similar in the two groups.
CONCLUSIONS


In patients with homozygous familial hypercholesterolemia receiving maximum doses of lipid-lowering therapy, the reduction from baseline in the LDL cholesterol level in the evinacumab group, as compared with the small increase in the placebo group, resulted in a between-group difference of 49.0 percentage points at 24 weeks. (Funded by Regeneron Pharmaceuticals; ELIPSE HoFH ClinicalTrials.gov number, NCT03399786.).",2020,The LDL cholesterol level was lower in the evinacumab group than in the placebo group in patients with null-null variants (-43.4% vs. +16.2%) and in those with non-null variants (-49.1% vs. -3.8%).,"['patients with homozygous familial hypercholesterolemia receiving maximum doses of', '65 patients with homozygous familial hypercholesterolemia who were receiving stable lipid-lowering therapy to receive an', 'Homozygous Familial Hypercholesterolemia', 'patients with homozygous familial hypercholesterolemia']","['lipid-lowering therapy', 'intravenous infusion of evinacumab', 'Evinacumab', 'placebo']","['Adverse events', 'mean baseline LDL cholesterol level', 'LDL cholesterol level', 'low-density lipoprotein (LDL) cholesterol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0342881', 'cui_str': 'Familial hypercholesterolemia - homozygous'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}, {'cui': 'C4508522', 'cui_str': 'evinacumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",65.0,0.54859,The LDL cholesterol level was lower in the evinacumab group than in the placebo group in patients with null-null variants (-43.4% vs. +16.2%) and in those with non-null variants (-49.1% vs. -3.8%).,"[{'ForeName': 'Frederick J', 'Initials': 'FJ', 'LastName': 'Raal', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Rosenson', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Laurens F', 'Initials': 'LF', 'LastName': 'Reeskamp', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'G Kees', 'Initials': 'GK', 'LastName': 'Hovingh', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Rubba', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Shazia', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Poulabi', 'Initials': 'P', 'LastName': 'Banerjee', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Kuo-Chen', 'Initials': 'KC', 'LastName': 'Chan', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Gipe', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Nagwa', 'Initials': 'N', 'LastName': 'Khilla', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Weinreich', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Yancopoulos', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gaudet', 'Affiliation': 'From the Faculty of Health Sciences, University of the Witwatersrand, Johannesburg (F.J.R.); the Cardiometabolics Unit, Zena and Michael A. Wiener Cardiovascular Institute, Marie-Josee and Henry R. Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York (R.S.R.), and Regeneron Pharmaceuticals, Tarrytown (S.A., P.B, K.-C.C., D.A.G., N.K., R.P., D.M.W. G.D.Y., Y.Z.) - both in New York; the Department of Vascular Medicine, University of Amsterdam, Amsterdam (L.F.R., G.K.H., J.J.P.K.); the Department of Internal Medicine and Surgery, Federico II University, Naples, Italy (P.R.); and the Clinical Lipidology and Rare Lipid Disorders Unit, Department of Medicine, Université de Montréal Community Gene Medicine Center, Lipid Clinic Chicoutimi Hospital and ECOGENE-21 Clinical and Translational Research Center, Chicoutimi, QC, Canada (D.G.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa2004215']
2645,32813949,Drug-Coated Balloons for Dysfunctional Dialysis Arteriovenous Fistulas.,"BACKGROUND


Standard percutaneous transluminal angioplasty is the current recommended treatment for dysfunctional hemodialysis fistulas, yet long-term outcomes of this treatment are poor. Drug-coated balloons delivering the antirestenotic agent paclitaxel may improve outcomes.
METHODS


In this prospective, single-blinded, 1:1 randomized trial, we enrolled 330 participants at 29 international sites. Patients with new or restenotic lesions in native upper-extremity arteriovenous fistulas were eligible for participation. After successful high-pressure percutaneous transluminal angioplasty, participants were randomly assigned to receive treatment with a drug-coated balloon or a standard balloon. The primary effectiveness end point was target-lesion primary patency, defined as freedom from clinically driven target-lesion revascularization or access-circuit thrombosis during the 6 months after the index procedure. The primary safety end point, serious adverse events involving the arteriovenous access circuit within 30 days, was assessed in a noninferiority analysis (margin of noninferiority, 7.5 percentage points). The primary analyses included all participants with available end-point data. Additional sensitivity analyses were performed to assess the effect of missing data.
RESULTS


A total of 330 participants underwent randomization; 170 were assigned to receive treatment with a drug-coated balloon, and 160 were assigned to receive treatment with a standard balloon. During the 6 months after the index procedure, target-lesion primary patency was maintained more often in participants who had been treated with a drug-coated balloon than in those who had been treated with a standard balloon (82.2% [125 of 152] vs. 59.5% [88 of 148]; difference in risk, 22.8 percentage points; 95% confidence interval [CI], 12.8 to 32.8; P<0.001). Drug-coated balloons were noninferior to standard balloons with respect to the primary safety end point (4.2% [7 of 166] and 4.4% [7 of 158], respectively; difference in risk, -0.2 percentage points; 95% CI, -5.5 to 5.0; P = 0.002 for noninferiority). Sensitivity analyses confirmed the results of the primary analyses.
CONCLUSIONS


Drug-coated balloon angioplasty was superior to standard angioplasty for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulas during the 6 months after the procedure and was noninferior with respect to access circuit-related serious adverse events within 30 days. (Funded by Medtronic; IN.PACT AV Access Study ClinicalTrials.gov number, NCT03041467.).",2020,"Drug-coated balloons were noninferior to standard balloons with respect to the primary safety end point (4.2% [7 of 166] and 4.4% [7 of 158], respectively; difference in risk, -0.2 percentage points; 95% CI, -5.5 to 5.0; P = 0.002 for noninferiority).","['Patients with new or restenotic lesions in native upper-extremity arteriovenous fistulas were eligible for participation', 'After successful high-pressure percutaneous transluminal angioplasty, participants', '330 participants underwent randomization; 170', 'Dysfunctional Dialysis Arteriovenous Fistulas', 'enrolled 330 participants at 29 international sites']","['Drug-coated balloon angioplasty', 'standard balloon', 'drug-coated balloon', 'percutaneous transluminal angioplasty', 'drug-coated balloon or a standard balloon', 'Drug-Coated Balloons']","['serious adverse events involving the arteriovenous access circuit', 'target-lesion primary patency, defined as freedom from clinically driven target-lesion revascularization or access-circuit thrombosis', 'target-lesion primary patency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0002996', 'cui_str': 'Balloon Angioplasty'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0450109', 'cui_str': 'Arteriovenous'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]",330.0,0.135022,"Drug-coated balloons were noninferior to standard balloons with respect to the primary safety end point (4.2% [7 of 166] and 4.4% [7 of 158], respectively; difference in risk, -0.2 percentage points; 95% CI, -5.5 to 5.0; P = 0.002 for noninferiority).","[{'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Lookstein', 'Affiliation': 'From Icahn School of Medicine at Mount Sinai (R.A.L.) and Syntactx (K.O.), New York; Haruguchi Vascular Access Clinic, Tokyo (H.H.); VasCore, Massachusetts General Hospital, Boston (I.W.); Medtronic, Plymouth, MN (L.L., S.C.); and the Department of Radiology, Auckland Hospital, Auckland, New Zealand (A.H.).'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Haruguchi', 'Affiliation': 'From Icahn School of Medicine at Mount Sinai (R.A.L.) and Syntactx (K.O.), New York; Haruguchi Vascular Access Clinic, Tokyo (H.H.); VasCore, Massachusetts General Hospital, Boston (I.W.); Medtronic, Plymouth, MN (L.L., S.C.); and the Department of Radiology, Auckland Hospital, Auckland, New Zealand (A.H.).'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ouriel', 'Affiliation': 'From Icahn School of Medicine at Mount Sinai (R.A.L.) and Syntactx (K.O.), New York; Haruguchi Vascular Access Clinic, Tokyo (H.H.); VasCore, Massachusetts General Hospital, Boston (I.W.); Medtronic, Plymouth, MN (L.L., S.C.); and the Department of Radiology, Auckland Hospital, Auckland, New Zealand (A.H.).'}, {'ForeName': 'Ido', 'Initials': 'I', 'LastName': 'Weinberg', 'Affiliation': 'From Icahn School of Medicine at Mount Sinai (R.A.L.) and Syntactx (K.O.), New York; Haruguchi Vascular Access Clinic, Tokyo (H.H.); VasCore, Massachusetts General Hospital, Boston (I.W.); Medtronic, Plymouth, MN (L.L., S.C.); and the Department of Radiology, Auckland Hospital, Auckland, New Zealand (A.H.).'}, {'ForeName': 'Lanyu', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': 'From Icahn School of Medicine at Mount Sinai (R.A.L.) and Syntactx (K.O.), New York; Haruguchi Vascular Access Clinic, Tokyo (H.H.); VasCore, Massachusetts General Hospital, Boston (I.W.); Medtronic, Plymouth, MN (L.L., S.C.); and the Department of Radiology, Auckland Hospital, Auckland, New Zealand (A.H.).'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Cihlar', 'Affiliation': 'From Icahn School of Medicine at Mount Sinai (R.A.L.) and Syntactx (K.O.), New York; Haruguchi Vascular Access Clinic, Tokyo (H.H.); VasCore, Massachusetts General Hospital, Boston (I.W.); Medtronic, Plymouth, MN (L.L., S.C.); and the Department of Radiology, Auckland Hospital, Auckland, New Zealand (A.H.).'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Holden', 'Affiliation': 'From Icahn School of Medicine at Mount Sinai (R.A.L.) and Syntactx (K.O.), New York; Haruguchi Vascular Access Clinic, Tokyo (H.H.); VasCore, Massachusetts General Hospital, Boston (I.W.); Medtronic, Plymouth, MN (L.L., S.C.); and the Department of Radiology, Auckland Hospital, Auckland, New Zealand (A.H.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1914617']
2646,32813958,Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.,,2020,,[],['Lactin-V'],['Recurrence of Bacterial Vaginosis'],[],[],"[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}]",,0.111901,,"[{'ForeName': 'Janneke H H M', 'Initials': 'JHHM', 'LastName': 'van de Wijgert', 'Affiliation': 'University Medical Center Utrecht, Utrecht, the Netherlands j.h.h.vandewijgert@umcutrecht.nl.'}, {'ForeName': 'Marijn C', 'Initials': 'MC', 'LastName': 'Verwijs', 'Affiliation': 'Canisius Wilhelmina Hospital, Nijmegen, the Netherlands.'}]",The New England journal of medicine,['10.1056/NEJMc2021832']
2647,32813959,Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.,,2020,,[],['Lactin-V'],['Recurrence of Bacterial Vaginosis'],[],[],"[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}]",,0.111901,,"[{'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Finucane', 'Affiliation': 'Massachusetts General Hospital, Boston, MA tfinucane@mgh.harvard.edu.'}]",The New England journal of medicine,['10.1056/NEJMc2021832']
2648,32813960,Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis. Reply.,,2020,,[],['Lactin-V'],['Recurrence of Bacterial Vaginosis'],[],[],"[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0085166', 'cui_str': 'Bacterial vaginosis'}]",,0.0999453,,"[{'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'University of California, San Francisco, San Francisco, CA craig.cohen@ucsf.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Parks', 'Affiliation': 'Osel, Mountain View, CA.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Hemmerling', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}]",The New England journal of medicine,['10.1056/NEJMc2021832']
2649,32813989,Mobilizing Carbon Dioxide Stores: An Experimental Study.,"RATIONALE


Understanding the physiology of CO 2  stores mobilization is a prerequisite for intermittent Extracorporeal CO 2  Removal (ECCO 2 R) in chronically hypercapnic patients.
OBJECTIVES


To describe the dynamics of CO 2  stores Methods: Fifteen pigs (61.7±4.3 kg) were randomized to: 48 hours hyperventilation (group ""Hyper"", n=4); 48 hours hypoventilation (group ""Hypo"", n=4), 24 hours hypoventilation plus 24 hours normoventilation (group ""Hypo-Baseline"", n=4); 24 hours hypoventilation + 24 hours hypoventilation+ECCO 2 R (group ""Hypo-ECCO 2 R"", n=3). Forty-eight hours after randomization the current minute ventilation was reduced by 50% in every pig.
MEASUREMENTS


CO 2  elimination (V̇CO 2 ), oxygen consumption (V̇O 2 ), metabolic V̇CO 2  (V̇O 2  times the metabolic respiratory quotient). Changes in the CO 2  stores were calculated as VO 2 -metabolic VCO 2 .
MAIN RESULTS


After 48 hours the CO 2  stores decreased by 0.77±0.17 l⸱kg-1 in group ""Hyper"" and increased by 0.32±0.27 l⸱kg-1 in group ""Hypo"" (p=0.030). In group ""Hypo-Baseline"" they increased by 0.08±0.19 l⸱kg-1 while in group ""Hypo-ECCO 2 R"" they decreased by 0.32±0.24 l⸱kg-1 (p=0.197). In the second 24 hours period, in group ""Hypo-Baseline"" and ""Hypo-ECCO 2 R"", the CO 2  stores decreased by 0.15±0.09 l⸱kg-1 and 0.51±0.06 l⸱kg-1, respectively (p=0.002). At the end of the experiment, the 50% reduction of minute ventilation caused a PaCO 2  rise of 9.3±1.1, 32.0±5.0, 16.9±1.2 and 11.7±2.0 mmHg⸱hr-1 in group ""Hyper"", ""Hypo"", ""Hypo-Baseline"" and ""Hypo-ECCO 2 R"", respectively (p<0.001). The PaCO 2  rise was inversely related to the previous CO 2  stores mobilization (p< 0.001).
CONCLUSIONS


CO 2  from body stores can be mobilized over 48 hours without reaching a steady state. This provides a physiological rationale for intermittent ECCO 2 R in chronically hypercapnic patients.",2020,"The PaCO 2  rise was inversely related to the previous CO 2  stores mobilization (p< 0.001).
","['CO 2  stores Methods: Fifteen pigs (61.7±4.3 kg', 'chronically hypercapnic patients']","['48 hours hyperventilation', 'Mobilizing Carbon Dioxide Stores', '24 hours hypoventilation plus 24 hours normoventilation (group ""Hypo-Baseline"", n=4); 24 hours hypoventilation + 24 hours hypoventilation+ECCO 2 R']","['CO 2  elimination (V̇CO 2 ), oxygen consumption (V̇O 2 ), metabolic V̇CO 2  (V̇O 2  times the metabolic respiratory quotient', 'current minute ventilation', 'CO 2  stores', 'minute ventilation']","[{'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0020578', 'cui_str': 'Hyperventilation'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C3203358', 'cui_str': 'Hypoventilation'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C1698986', 'cui_str': 'Storage'}]",,0.0217786,"The PaCO 2  rise was inversely related to the previous CO 2  stores mobilization (p< 0.001).
","[{'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Giosa', 'Affiliation': 'University of Goettingen, Department for Anesthesiology and Intensive Care Medicine Goettingen, DE , Göttingen, Germany.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Busana', 'Affiliation': 'University of Goettingen, Department for Anesthesiology, Intensive Care and Emergency Medicine, Goettingen, Germany.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bonifazi', 'Affiliation': 'University of Göttingen, Department of Anaesthesiology, Emergency and Intensive Care Medicine , Göttingen, Germany.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Romitti', 'Affiliation': 'University of Göttingen, Department of Anaesthesiology, Emergency and Intensive Care Medicine, Göttingen, Germany.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Vassalli', 'Affiliation': 'University of Göttingen, Department of Anaesthesiology, Emergency and Intensive Care Medicine, Göttingen, Germany.'}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Pasticci', 'Affiliation': 'University of Göttingen, Department of Anaesthesiology, Emergency and Intensive Care Medicine, Göttingen, Germany.'}, {'ForeName': 'Matteo Maria', 'Initials': 'MM', 'LastName': 'Macrì', 'Affiliation': 'University of Gottingen, 9375, Department for Anesthesiology and Intensive Care Medicine Goettingen, DE , Gottingen, Germany.'}, {'ForeName': 'Rosanna', 'Initials': 'R', 'LastName': ""D'Albo"", 'Affiliation': 'University of Göttingen, Department of Anaesthesiology, Emergency and Intensive Care Medicine, Göttingen, Germany.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Collino', 'Affiliation': 'Humanitas Clinical and Research Center, Department of Anesthesia and Intensive Care Medicine, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gatta', 'Affiliation': ""Rimini - Riccione, AUSL Romagna, Department of Anesthesia and Critical Care, Forli' , Italy.""}, {'ForeName': 'Maria Michela', 'Initials': 'MM', 'LastName': 'Palumbo', 'Affiliation': 'University of Göttingen, Department of Anaesthesiology, Emergency and Intensive Care Medicine, Göttingen, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Herrmann', 'Affiliation': 'University of Göttingen, Department of Anaesthesiology, Emergency and Intensive Care Medicine, Göttingen, Germany.'}, {'ForeName': 'Onnen', 'Initials': 'O', 'LastName': 'Moerer', 'Affiliation': 'University of Göttingen, Department of Anaesthesiology, Emergency and Intensive Care Medicine, Göttingen, Germany.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Iapichino', 'Affiliation': 'University of Milan, 9304, Past Professor of Anesthesia and Intensive Care, Milano, Italy.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Meissner', 'Affiliation': 'University of Göttingen, Department of Anaesthesiology, Emergency and Intensive Care Medicine, Göttingen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Quintel', 'Affiliation': 'University of Göttingen, Anaesthesiology, Emergency and Intensive Care Medicine, Göttingen, Germany.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'Gattinoni', 'Affiliation': 'University of Göttingen, Department of Anaesthesiology, Emergency and Intensive Care Medicine, Göttingen, Germany; gattinoniluciano@gmail.com.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.202005-1687OC']
2650,32814493,Effectiveness of acupoint pressure on older people with constipation in nursing homes: A double-blind quasi-experimental study.,"Aims:  To compare the differences between acupoint pressure, abdominal massage and laxatives in treatment of constipation for residents in two nursing homes.  Background:  There is lack of evidence on the utility of complementary therapies in the management of constipation among older adults.  Design:  Quasi-experimental.  Methods:  A total of 90 participants from two nursing homes in Taiwan were assigned to three groups: the control group (with laxatives only), group I (with laxatives and abdominal massage) and group II (with laxatives, acupoint pressure therapy [APT] and abdominal massage). The intervention was performed over 10 days. A double-blind technique was applied in both participants and the outcome assessors. Constipation as main outcome was evaluated and recorded for 10 days. Observation of the frequency of defecation and the consistency, particularly firmness of faeces over each 24 hours' period was recorded. The Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) checklist was utilised in reporting methods and findings.  Results:  Three variations were revealed as interface factors and showed significant differences in each group. The results showed a statistically significant decrease in constipation in the experimental groups I and II. The scores of defecation frequency, difficulty degree and time of defecation, stool quality and awareness of defecation were obviously improved after treatment.  Conclusions:  We concluded APT could be used in conjunction with laxatives and must be considered as a long-term intervention. The combination of APT, abdominal massage and laxatives is superior to both abdominal massage with laxatives and laxatives alone.  Relevance to clinical practice:  Acupoint pressure as an effective complementary therapy of constipation among older adults living in nursing home provides a non-pharmacological, independent nursing intervention that nurses could use. This is relevant to nursing home settings where nurses make autonomous decision on important clinical assessments and interventions.",2020,"To compare the differences between acupoint pressure, abdominal massage and laxatives in treatment of constipation for residents in two nursing homes.  ","['older adults', 'older adults living in nursing home', '90 participants from two nursing homes in Taiwan', 'constipation for residents in two nursing homes', 'older people with constipation in nursing homes']","['Acupoint pressure', 'acupoint pressure', 'control group (with laxatives only), group I (with laxatives and abdominal massage) and group II (with laxatives, acupoint pressure therapy [APT] and abdominal massage', 'acupoint pressure, abdominal massage and laxatives']","['scores of defecation frequency, difficulty degree and time of defecation, stool quality and awareness of defecation', 'constipation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282090', 'cui_str': 'Laxative'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C2316341', 'cui_str': 'Massage of abdomen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]",90.0,0.0311967,"To compare the differences between acupoint pressure, abdominal massage and laxatives in treatment of constipation for residents in two nursing homes.  ","[{'ForeName': 'Mu-Hsing', 'Initials': 'MH', 'LastName': 'Ho', 'Affiliation': 'MSc, RN, PhD student, School of Nursing, Faculty of Science, Medicine and Health, University of Wollongong, New South Wales, Australia and Registered Nurse, Department of Nursing, Taipei Medical University Hospital, Taipei, Taiwan. E-mail: mhh838@uowmail.edu.au.'}, {'ForeName': 'Hui Chen Rita', 'Initials': 'HCR', 'LastName': 'Chang', 'Affiliation': 'PhD, RN, Senior Lecturer, School of Nursing, Faculty of Science, Medicine and Health, University of Wollongong, New South Wales, Australia. E-mail: hchang@uow.edu.au.'}, {'ForeName': 'Megan F', 'Initials': 'MF', 'LastName': 'Liu', 'Affiliation': 'PhD, RN, Associate Professor, School of Gerontology Health Management, Taipei Medical University, Taipei, Taiwan. E-mail: fangliu@tmu.edu.tw.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'PhD, Research Staff, School of Nursing, Faculty of Science, Medicine and Health, University of Wollongong, New South Wales, Australia. E-mail: yuan_lin@uow.edu.au.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Montayre', 'Affiliation': 'PhD, RN, Senior Lecturer, School of Nursing and Midwifery, Western Sydney University, New South Wales, Australia. E-mail: j.montayre@westernsydney.edu.au.'}]",Contemporary nurse,['10.1080/10376178.2020.1813042']
2651,32814500,"A quasi-experimental study examining QR code-based video education program on anxiety, adherence, and satisfaction in coronary angiography patients.","Background:  QR (quick response) codes are a promising tool for health education, however effects of QR code application in providing peri-procedure education to patients with coronary angiography is unclear.  Aim/Objective:  This study investigated the effect of a QR code-based video education program on anxiety, adherence, and satisfaction in Chinese coronary angiography patients.  Material and Methods:  This prospective controlled clinical trial included 335 patients undergoing coronary angiography, including 166 patients in the experimental group and 169 patients in the control group. On the day before coronary angiography, patients in the experimental group had access to and could watch an educational video on their smartphones by scanning a QR code for multiple times, while patients in the control group watched the same video on a tablet once only. The primary outcome was anxiety assessed using the Chinese State Anxiety Inventory (C-SAI). Adherence to instructions and patient satisfaction with the information delivery method were also evaluated.  Results:  The C-SAI scores improved in the experimental group compared to the control group ( F  = 9.8,  P <0.001) over time. There is a significant difference in the changes of anxiety scores from baseline to pre-procedure ( P <0.001) and post-procedure ( P <0.01) between the two groups. Individuals in the experimental group showed better adherence to instructions on removing dentures and jewelry, and taking medicines before the procedure ( P <0.05), and limb activity, water consumption, and diet after the procedure ( P <0.001).  Conclusion:  Patient education programs on smartphone that can be accessed multiple times by scanning a QR code can be effective and convenient approach to reducing anxiety and enhancing adherence to instructions among Chinese coronary angiography patients. Hospitals and clinicians should consider more investments in developing such patient education programs and also help improve ehealth literacy.  Impact statement:  QR code-based Video education program can improve anxiety and adherence and satisfaction among coronary angiography patients.",2020,"Individuals in the experimental group showed better adherence to instructions on removing dentures and jewelry, and taking medicines before the procedure ( P <0.05), and limb activity, water consumption, and diet after the procedure ( P <0.001).  ","['335 patients undergoing coronary angiography, including 166 patients in the experimental group and 169 patients in the control group', 'coronary angiography patients', 'Chinese coronary angiography patients']","['QR code-based video education program', 'QR code-based Video education program']","['C-SAI scores', 'anxiety, adherence, and satisfaction', 'limb activity, water consumption, and diet', 'adherence to instructions on removing dentures and jewelry, and taking medicines', 'anxiety assessed using the Chinese State Anxiety Inventory (C-SAI', 'anxiety and adherence and satisfaction', 'anxiety scores', 'QR (quick response']","[{'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C5191361', 'cui_str': '166'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013123', 'cui_str': 'Water intake'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0455015', 'cui_str': 'Removing dentures'}, {'cui': 'C0336902', 'cui_str': 'Jewelry'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}]",335.0,0.0541309,"Individuals in the experimental group showed better adherence to instructions on removing dentures and jewelry, and taking medicines before the procedure ( P <0.05), and limb activity, water consumption, and diet after the procedure ( P <0.001).  ","[{'ForeName': 'Jingwen', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': ""Department of Cardiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': ""Department of Cardiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ""Clinical Research Center, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Zhijian', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.""}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Eye Institute, Xi'an City First Hospital, Xi'an, China.""}]",Contemporary nurse,['10.1080/10376178.2020.1813043']
2652,32814506,The effect of calcium co-ingestion on exogenous glucose oxidation during endurance exercise in healthy men: A Pilot Study.,"The benefits of high exogenous glucose availability for endurance exercise performance are well-established. Exogenous glucose oxidation rates are thought to be limited by intestinal glucose transport. Extracellular calcium in rodent intestine increases the translocation of the intestinal glucose transporter GLUT2 which, if translated to humans, could increase the capacity for exogenous glucose availability during exercise. Therefore, this pilot study aimed to explore the effect of calcium co-ingestion during endurance exercise on exogenous glucose oxidation in healthy men. Eight healthy men cycled for 2 h at 50% peak power output, ingesting either 1.2 g·min -1  dextrose alone (GLU) or with the addition of 2000 mg calcium (GLU+CAL), in a randomised crossover design. Expired breath samples were collected to determine whole-body and exogenous glucose oxidation. Peak exogenous glucose oxidation during GLU was 0.83±0.15 g·min -1 , and was not enhanced during GLU+CAL (0.88±0.11 g·min -1 ,  p  = 0.541). The relative contributions of exogenous carbohydrate (19±3% vs. 20±2%,  p  = 0.434), endogenous carbohydrate (65±3% vs. 65±3%,  p  = 0.822) and fat (16±3% vs. 15±3%,  p  = 0.677) to total substrate utilisation did not differ between trials. These results suggest the addition of calcium to glucose ingestion, at saturating glucose ingestion rates, does not appear to alter exogenous glucose oxidation during endurance exercise in healthy men.",2020,"The relative contributions of exogenous carbohydrate (19±3% vs. 20±2%,  p  = 0.434), endogenous carbohydrate (65±3% vs. 65±3%,  p  = 0.822) and fat (16±3% vs. 15±3%,  p  = 0.677) to total substrate utilisation did not differ between trials.","['Eight healthy men cycled for 2 h at 50% peak power output, ingesting either 1.2', 'healthy men']","['g·min -1  dextrose alone (GLU) or with the addition of 2000 mg calcium (GLU+CAL', 'calcium co-ingestion during endurance exercise', 'calcium co-ingestion']","['endogenous carbohydrate', 'Exogenous glucose oxidation rates', 'total substrate utilisation', 'exogenous glucose oxidation', 'relative contributions of exogenous carbohydrate', 'Peak exogenous glucose oxidation']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4068880', 'cui_str': '1.2'}]","[{'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}]","[{'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",,0.0542746,"The relative contributions of exogenous carbohydrate (19±3% vs. 20±2%,  p  = 0.434), endogenous carbohydrate (65±3% vs. 65±3%,  p  = 0.822) and fat (16±3% vs. 15±3%,  p  = 0.677) to total substrate utilisation did not differ between trials.","[{'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Narang', 'Affiliation': 'Department for Health, University of Bath, Bath, UK. bjn25@bath.ac.uk.'}, {'ForeName': 'Gareth A', 'Initials': 'GA', 'LastName': 'Wallis', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK. G.A.Wallis@bham.ac.uk.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, UK. bjn25@bath.ac.uk.'}]",European journal of sport science,['10.1080/17461391.2020.1813336']
2653,32814508,Comparing the Effects of Reading Intervention Versus Reading and Mindset Intervention for Upper Elementary Students With Reading Difficulties.,"The primary purpose of this study was to examine the effects of providing mindset intervention in addition to reading intervention compared with only reading intervention for fourth graders with reading difficulties. Reading intervention was provided daily in 45 min sessions throughout the school year. Mindset intervention occurred in small groups for 24-30 min lessons. Multilevel structural equation modeling (SEM) via  n- level SEM was used to account for the latent variable representation of constructs, and the complex nesting and cross-classification structure of the data. Students in the reading intervention plus mindset condition significantly outperformed the business as usual condition on nonword reading ( d  = 0.35) as did students in the reading intervention condition ( d  = 0.20), who also outperformed the business as usual condition on phonological processing ( d  = 0.28). There were no significant differences among students in the three conditions on nonword reading, word reading, phonological processing, reading comprehension, or growth mindset. Initial reading achievement, mindset, and problem behavior did not generally moderate these findings.",2020,"There were no significant differences among students in the three conditions on nonword reading, word reading, phonological processing, reading comprehension, or growth mindset.","['Upper Elementary Students With Reading Difficulties', 'fourth graders with reading difficulties']","['Multilevel structural equation modeling (SEM) via  n', 'Reading Intervention Versus Reading and Mindset Intervention', 'mindset intervention']","['nonword reading, word reading, phonological processing, reading comprehension, or growth mindset', 'Initial reading achievement, mindset, and problem behavior']","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0586742', 'cui_str': 'Difficulty reading'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}]","[{'cui': 'C0681947', 'cui_str': 'Structural Equation Modeling'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]",,0.0204287,"There were no significant differences among students in the three conditions on nonword reading, word reading, phonological processing, reading comprehension, or growth mindset.","[{'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Wanzek', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Stephanie Al', 'Initials': 'SA', 'LastName': 'Otaiba', 'Affiliation': 'Southern Methodist University, Dallas, TX, USA.'}, {'ForeName': 'Yaacov', 'Initials': 'Y', 'LastName': 'Petscher', 'Affiliation': 'Florida State University, Tallahassee, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lemons', 'Affiliation': 'Stanford University, CA, USA.'}, {'ForeName': 'Samantha A', 'Initials': 'SA', 'LastName': 'Gesel', 'Affiliation': 'University of North Carolina at Charlotte, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Fluhler', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Donegan', 'Affiliation': 'Northern Illinois University, Nashville, TN, USA.'}, {'ForeName': 'Brenna K', 'Initials': 'BK', 'LastName': 'Rivas', 'Affiliation': 'Southern Methodist University, Dallas, TX, USA.'}]",Journal of learning disabilities,['10.1177/0022219420949281']
2654,32819529,Impact of Female Sex on Clinical Presentation and Ablation Outcomes in the CIRCA-DOSE Study.,"OBJECTIVES


This study sought to evaluate sex-specific differences in atrial fibrillation (AF) presentation and catheter ablation outcomes in the prospective, multicenter, randomized CIRCA-DOSE (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration) study.
BACKGROUND


Similar to other cardiovascular conditions, significant sex-specific differences have been observed in the epidemiology, pathophysiology, presentation, and natural history of AF. Unfortunately, there are major gaps in our understanding of the pathophysiological basis for the observed sex-specific differences and their implications on therapy and prognosis.
METHODS


This study examined sex-specific differences in AF presentation, symptom severity and health-related quality of life, symptomatic and asymptomatic arrhythmia recurrence, AF burden, and health care utilization.
RESULTS


Freedom from any atrial tachyarrhythmia and symptomatic atrial tachyarrhythmia were similar between male (hazard ratio: 1.18; 95% confidence interval: 0.85 to 1.64; p = 0.39) and female patients (hazard ratio: 1.00; 95% confidence interval: 0.62 to 1.59; p = 0.92). Post-ablation, the median AF burden (percentage time in AF) was 0.00% (interquartile range: 0.00% to 0.16%) in male patients and 0.00% (interquartile range: 0.00% to 0.17%) in female patients, with no difference observed between the sexes (p = 0.30). Periprocedural complications occurred twice as frequently in female patients (3.5% vs. 7.0%; p = 0.18). In comparison to male patients, female patients reported a significantly worse symptom score and quality of life at baseline and all follow-up intervals, but they derived similar magnitude of improvement post-ablation. There was no difference between male and female patients with respect to emergency department visits, hospitalization, cardioversion, or repeat ablation.
CONCLUSIONS


When compared with male patients, female patients have significantly worse symptom scores and quality of life at baseline. Despite this, female patients with symptomatic paroxysmal AF derive similar benefit in freedom from recurrent arrhythmia and similar improvements in quality of life following AF ablation. (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration [CIRCA-DOSE]; NCT01913522).",2020,"There was no difference between male and female patients with respect to emergency department visits, hospitalization, cardioversion, or repeat ablation.
",['female patients with symptomatic paroxysmal AF'],"['Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation: Double Short vs. Standard Exposure Duration [CIRCA-DOSE', 'CIRCA-DOSE (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation']","['quality of life', 'symptom score and quality of life', 'atrial tachyarrhythmia and symptomatic atrial tachyarrhythmia', 'median AF burden', 'emergency department visits, hospitalization, cardioversion, or repeat ablation', 'AF presentation, symptom severity and health-related quality of life, symptomatic and asymptomatic arrhythmia recurrence, AF burden, and health care utilization', 'symptom scores and quality of life', 'Periprocedural complications']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}]","[{'cui': 'C0162561', 'cui_str': 'Radiofrequency Catheter Ablation'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C1141861', 'cui_str': 'Procedural complication'}]",,0.0558922,"There was no difference between male and female patients with respect to emergency department visits, hospitalization, cardioversion, or repeat ablation.
","[{'ForeName': 'Ren Jie Robert', 'Initials': 'RJR', 'LastName': 'Yao', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Data Science Institute, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Nathaniel M', 'Initials': 'NM', 'LastName': 'Hawkins', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Sedlak', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Nault', 'Affiliation': 'Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Southlake Regional Health Centre, Newmarket, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada; Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada. Electronic address: Jason.andrade@vch.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2020.04.032']
2655,32819616,"Erratum to: Pollack A, Chinea FM, Bossart E, Kwon D, Abramowitz MC, Lynne C, Jorda M, Marples B, Patel VN, Wu XD, Reis I, Studenski MT, Casillas J, Stoyanova R. Phase I Trial of MRI-Guided Prostate Cancer Lattice Extreme Ablative Dose (LEAD) Boost Radiation Therapy. Int J Radiat Oncol Biol Phys 2020;107:305-315.",,2020,,[],"['MRI-Guided Prostate Cancer Lattice Extreme Ablative Dose (LEAD', 'Int J Radiat Oncol Biol', 'Boost Radiation Therapy']",[],[],"[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2919491', 'cui_str': 'Boost radiation therapy'}]",[],,0.0165785,,[],"International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.05.061']
2656,32819681,Five-Year Outcomes and Prognostic Value of Feature-Tracking Cardiovascular Magnetic Resonance in Patients Receiving Early Prereperfusion Metoprolol in Acute Myocardial Infarction.,"The aim of the present study was to investigate the long-term impact of early intravenous metoprolol in ST-segment elevation myocardial infarction (STEMI) patients in terms of left ventricular (LV) strain with feature-tracking cardiovascular magnetic resonance (CMR) and its association with prognosis. A total of 270 patients with first anterior STEMI enrolled in the randomized METOCARD-CNIC clinical trial, assigned to receive up to 15 mg intravenous metoprolol before primary percutaneous coronary intervention versus conventional STEMI therapy, were included. LV global circumferential (GCS) and longitudinal (GLS) strain were assessed with feature-tracking CMR at 1 week after STEMI in 215 patients. The occurrence of major adverse cardiac events (MACE) at 5-year follow-up was the primary end point. Among 270 patients enrolled, 17 of 139 patients assigned to metoprolol arm and 31 of 131 patients assigned to control arm experienced MACE (hazard ratio [HR] 0.500, 95% confidence interval [CI] 0.277 to 0.903; p = 0.022). Impaired LV GCS and GLS strain were significantly associated with increased occurrence of MACE (GCS: HR 1.208, 95% CI 1.076 to 1.356, p =0.001; GLS: HR 1.362, 95% CI 1.180 to 1.573, p < 0.001). On multivariable analysis, LV GLS provided incremental prognostic value over late gadolinium enhancement (LGE) and LV ejection fraction (LVEF) (LGE + LVEF chi-square = 12.865, LGE + LVEF + GLS chi-square = 18.459; p =0.012). Patients with GLS ≥-11.5% (above median value) who received early intravenous metoprolol were 64% less likely to experience MACE than their counterparts with same degree of GLS impairment (HR 0.356, 95% CI 0.129 to 0.979; p = 0.045). In conclusion, early intravenous metoprolol has a long-term beneficial prognostic effect, particularly in patients with severely impaired LV systolic function. LV GLS with feature-tracking CMR early after percutaneous coronary intervention offers incremental prognostic value over conventional CMR parameters in risk stratification of STEMI patients.",2020,"Impaired LV GCS and GLS strain were significantly associated with increased occurrence of MACE (GCS: HR 1.208, 95% CI 1.076 to 1.356, p =0.001; GLS: HR 1.362, 95% CI 1.180 to 1.573, p < 0.001).","['215 patients', 'STEMI patients', 'Patients Receiving Early Prereperfusion Metoprolol in Acute Myocardial Infarction', '270 patients enrolled, 17 of 139 patients assigned to', 'patients with severely impaired LV systolic function', '270 patients with first anterior STEMI enrolled']","['metoprolol before primary percutaneous coronary intervention versus conventional STEMI therapy', 'metoprolol']","['incremental prognostic value over late gadolinium enhancement (LGE) and LV ejection fraction (LVEF) (LGE\u202f+\u202fLVEF chi-square', 'GLS impairment', 'occurrence of major adverse cardiac events (MACE', 'LV global circumferential (GCS) and longitudinal (GLS) strain', 'Impaired LV GCS and GLS strain']","[{'cui': 'C4709308', 'cui_str': '215'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C4319603', 'cui_str': '270'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}]","[{'cui': 'C0025859', 'cui_str': 'Metoprolol'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0016911', 'cui_str': 'Gadolinium'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}]",270.0,0.0522323,"Impaired LV GCS and GLS strain were significantly associated with increased occurrence of MACE (GCS: HR 1.208, 95% CI 1.076 to 1.356, p =0.001; GLS: HR 1.362, 95% CI 1.180 to 1.573, p < 0.001).","[{'ForeName': 'Tomaž', 'Initials': 'T', 'LastName': 'Podlesnikar', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands; University Medical Centre Maribor, Maribor, Slovenia; Internal Medicine Clinic, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Pizarro', 'Affiliation': 'CentroNacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; CIBER de enfermedades CardioVasculares (CIBERCV), Madrid, Spain; Ruber Juan Bravo Hospital Universidad Europea, Madrid, Spain.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Fernández-Jiménez', 'Affiliation': 'CentroNacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; CIBER de enfermedades CardioVasculares (CIBERCV), Madrid, Spain; Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Montero-Cabezas', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sánchez-González', 'Affiliation': 'Philips Healthcare, Madrid, Spain.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Bucciarelli-Ducci', 'Affiliation': 'Bristol Heart Institute, Bristol NIHR Cardiovascular Research Centre, University of Bristol and University Hospitals Bristol NHS Trust, Bristol, United Kingdom.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Ajmone Marsan', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Zlatko', 'Initials': 'Z', 'LastName': 'Fras', 'Affiliation': 'Internal Medicine Clinic, University Medical Centre Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Jeroen J', 'Initials': 'JJ', 'LastName': 'Bax', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Fuster', 'Affiliation': 'CentroNacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Ibáñez', 'Affiliation': 'CentroNacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain; CIBER de enfermedades CardioVasculares (CIBERCV), Madrid, Spain; IIS-Fundación Jiménez Díaz University Hospital, Madrid, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Delgado', 'Affiliation': 'Department of Cardiology, Heart Lung Center, Leiden University Medical Center, Leiden, The Netherlands. Electronic address: v.delgado@lumc.nl.'}]",The American journal of cardiology,['10.1016/j.amjcard.2020.07.037']
2657,32819728,[Comparison of two doses of intra-articular tranexamic acid on postoperative bleeding in total knee arthroplasty: a randomized clinical trial].,"INTRODUCTION


Tranexamic Acid (TXA), an antifibrinolytic that inhibits the fibrinolytic activity of plasmin is used to decrease perioperative blood loss and transfusion requirements in orthopedic surgery. The aim of our study was to compare postoperative bleeding in two intra-articular doses (1g and 2g) of tranexamic acid in adult patients undergoing unilateral total knee replacement.
METHOD


We conducted a single-operator, randomized, and controlled, double-blind study in two groups. The G1 group received 1g of intra-articular TXA and the G2 group 2g of intra-articular TXA. Both groups received 15mg.kg -1  IV before the surgical incision (TXA induction dose) and then 10mg.kg -1 , orally, 6 and 12hours after the induction dose of TXA. The primary endpoint was bleeding measured by blood loss in postoperative drainage. Secondary outcomes were change in hemoglobin and hematocrit levels on the first and third postoperative days, and the need for transfusion during hospitalization.
RESULTS


In total, 100 patients were randomized, and 100 were included in the analysis. Blood loss in postoperative drainage was similar in both groups (200±50 vs. 250±50mL, G1 and G2 groups respectively). Change in hematocrit and hemoglobin values (% of change) between preoperative and day 3 were not statically significant between groups G1 and G2 (18±5 vs. 21±4; 21±7 vs. 22±5 respectively). No patients received blood transfusion.
CONCLUSIONS


Our study did not show superiority of 2g of intra-articular tranexamic acid compared to 1g. ClinicalTrials.gov Identifier NCT04085575.",2020,"Blood loss in postoperative drainage was similar in both groups (200±50 vs. 250±50mL, G1 and G2 groups respectively).","['total knee arthroplasty', 'adult patients undergoing unilateral total knee replacement', '100 patients were randomized, and 100 were included in the analysis']","['TXA', 'intra-articular TXA and the G2 group 2g of intra-articular TXA', 'intra-articular tranexamic acid', 'Tranexamic Acid (TXA', 'tranexamic acid']","['Blood loss in postoperative drainage', 'change in hemoglobin and hematocrit levels on the first and third postoperative days, and the need for transfusion during hospitalization', 'bleeding measured by blood loss in postoperative drainage', 'hematocrit and hemoglobin values', 'postoperative bleeding']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032788', 'cui_str': 'Postoperative hemorrhage'}]",100.0,0.369044,"Blood loss in postoperative drainage was similar in both groups (200±50 vs. 250±50mL, G1 and G2 groups respectively).","[{'ForeName': 'Edmundo Pereira de', 'Initials': 'EP', 'LastName': 'Souza Neto', 'Affiliation': ""Centre Hospitalier de Montauban, Département d'Anesthésie, Montauban, France. Electronic address: edmundo.pereira-de-souza@hotmail.fr.""}, {'ForeName': 'Gorka', 'Initials': 'G', 'LastName': 'Usandizaga', 'Affiliation': 'Centre Hospitalier de Montauban, Département de Chirurgie Orthopédique et Traumatologie, Montauban, France.'}]",Revista brasileira de anestesiologia,['10.1016/j.bjan.2020.03.015']
2658,32819740,The Impact of a 20-Minute Animal-Assisted Activity Session on the Physiological and Emotional States in Patients With Fibromyalgia.,"OBJECTIVE


To study the direct physiological and emotional impact of an animal-assisted activity (AAA) session (a form of complementary and integrative medicine) in patients with fibromyalgia (FM).
PATIENTS AND METHODS


The study population consisted of 221 participants with FM who were attending Mayo Clinic's Fibromyalgia Treatment Program between August 5, 2017, and September 1, 2018. This was a randomized controlled trial. Participants were randomly assigned to either the treatment group (a 20-minute session with a certified therapy dog and handler) or the control group (a 20-minute session with a handler only). To gain a better understanding of the direct physiological and emotional effects of AAA in patients with FM, we used multiple noninvasive physiologic-emotional biomarkers, including salivary cortisol and oxytocin concentrations, tympanic membrane temperatures, and various cardiac parameters, in addition to standardized pain and mood-based questionnaires.
RESULTS


Results show a decrease in heart rate, an increase in heart rate variability, an increase in well-being survey scores, an increase in salivary oxytocin, and subsequent tympanic membrane temperature changes, suggesting that participants in the treatment group were in a more positive emotional-physiologic state as a result of the AAA session compared with the control group.
CONCLUSION


Our results suggest that a 20-minute therapy dog visit in an outpatient setting can significantly and positively impact the physical and mental health of patients with FM.",2020,Participants were randomly assigned to either the treatment group (a 20-minute session with a certified therapy dog and handler) or the control group (a 20-minute session with a handler only).,"[""221 participants with FM who were attending Mayo Clinic's Fibromyalgia Treatment Program between August 5, 2017, and September 1, 2018"", 'patients with fibromyalgia (FM', 'Patients With Fibromyalgia', 'patients with FM']","['certified therapy dog and handler) or the control group (a\xa020-minute session with a handler only', '20-Minute Animal-Assisted Activity Session', 'animal-assisted activity (AAA) session (a form of complementary and integrative medicine']","['heart rate', 'salivary oxytocin, and subsequent tympanic membrane temperature changes', 'well-being survey scores', 'positive emotional-physiologic state', 'heart rate variability', 'salivary cortisol and oxytocin concentrations, tympanic membrane temperatures, and various cardiac parameters']","[{'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2350258', 'cui_str': 'Integrative Medicine'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0041445', 'cui_str': 'Tympanic membrane structure'}, {'cui': 'C0450031', 'cui_str': 'Temperature change'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",221.0,0.0903234,Participants were randomly assigned to either the treatment group (a 20-minute session with a certified therapy dog and handler) or the control group (a 20-minute session with a handler only).,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Clark', 'Affiliation': 'Section of Integrative Medicine and Health, Division of General Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Martin', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Ragen T S', 'Initials': 'RTS', 'LastName': 'McGowan', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Smidt', 'Affiliation': 'Section of Integrative Medicine and Health, Division of General Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Anderson', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Turpin', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Langenfeld-McCoy', 'Affiliation': 'Nestlé Purina Research, St. Louis, MO.'}, {'ForeName': 'Brent', 'Initials': 'B', 'LastName': 'Bauer', 'Affiliation': 'Section of Integrative Medicine and Health, Division of General Internal Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Arya B', 'Initials': 'AB', 'LastName': 'Mohabbat', 'Affiliation': 'Section of Integrative Medicine and Health, Division of General Internal Medicine, Mayo Clinic, Rochester, MN. Electronic address: mohabbat.arya@mayo.edu.'}]",Mayo Clinic proceedings,['10.1016/j.mayocp.2020.04.037']
2659,32819949,Comparing two dry needling interventions for plantar heel pain: a randomised controlled trial.,"OBJECTIVES


To compare the effectiveness of dry needling (DN) versus percutaneous needle electrolysis (PNE) for improving the level of pain, function and quality of life (QoL) of patients suffering from plantar heel pain (PHP) provoked by myofascial trigger points.
DESIGN


A prospective, parallel-group, randomised controlled trial with blinded outcome assessment.
SETTING


A single treatment facility in the State of Kuwait.
PARTICIPANTS


118 participants were screened for eligibility. Of these, 102 participants were enrolled (30 men (49.5±8.9 years) and 72 women (48.1±8.8 years)) and 68 of them completed the trial.
INTERVENTIONS


Two parallel groups, one study arm received DN and a stretching protocol whereas the other arm received percutaneous needling electrolysis with a stretching protocol.
PRIMARY AND SECONDARY OUTCOME MEASURES


The primary outcome measure was the Foot Pain domain of the Foot Health Status Questionnaire, with 13 questions related to foot health-related domains. Secondary outcome measures included the 0-10 numerical rating scale pain visual analogue scale (VAS) scores, performed before and after each treatment session. In addition, QoL was measured using the EuroQoL-5 dimensions. All measurements were taken at baseline, at 4, 8, 12, 26 and 52 weeks.
RESULTS


Foot Pain domain improved at all time points for DN group (p<0.001; 29.7 (17.8 to 41.5)) and percutaneous needling electrolysis group (p<0.001; 32.7 (18.3 to 47.0)), without significant differences between groups. Pain VAS scores decreased at all time points for both DN (p<0.001; -2.6 (-4.0 to -1.2)) and percutaneous needling electrolysis group (p<0.001; -3.0 (-4.5 to -1.6)). QoL improved at 4 weeks for both DN (p<0.01; 0.15 (0.5 to 0.25)) and percutaneous needling electrolysis group (p<0.01; 0.09 (0.01 to 0.17)) and at 8 and 52 weeks for the PNE group (p<0.01; 0.10 (0.02 to 0.18)), with significant differences between groups for the QoL at 52 weeks (p<0.05; 0.10 (0.01 to 0.18)). There were two small haematomas in the PNE group and one in the DN group. No serious adverse events were reported.
CONCLUSIONS


Both PNE and DN were effective for PHP management, reducing mean and maximum pain since the first treatment session, with long lasting effects (52 weeks) and significant differences between groups in the case of QoL at 52 weeks in favour of the PNE group.
TRIAL REGISTRATION NUMBER


NCT03236779.",2020,Pain VAS scores decreased at all time points for both DN (p<0.001; -2.6,"['patients suffering from plantar heel pain (PHP) provoked by myofascial trigger points', 'A single treatment facility in the State of Kuwait', '118 participants were screened for eligibility', 'plantar heel pain', '102 participants were enrolled (30 men (49.5±8.9 years) and 72 women (48.1±8.8 years)) and 68 of them completed the trial']","['percutaneous needling electrolysis with a stretching protocol', 'percutaneous needling electrolysis', 'dry needling (DN) versus percutaneous needle electrolysis (PNE', 'dry needling interventions', 'DN and a stretching protocol']","['QoL', 'Pain VAS scores', 'level of pain, function and quality of life (QoL', '0-10 numerical rating scale pain visual analogue scale (VAS) scores', 'serious adverse events', 'Foot Pain domain of the Foot Health Status Questionnaire, with 13 questions related to foot health-related domains', 'Foot Pain domain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231786', 'cui_str': 'Plantar heel pain'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0022804', 'cui_str': 'Kuwait'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0013829', 'cui_str': 'Electrolysis - action'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0016512', 'cui_str': 'Foot pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",118.0,0.160401,Pain VAS scores decreased at all time points for both DN (p<0.001; -2.6,"[{'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Al-Boloushi', 'Affiliation': 'Fisiatría y Enfermería, Universidad de Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Eva Maria', 'Initials': 'EM', 'LastName': 'Gómez-Trullén', 'Affiliation': 'Fisiatría y Enfermería, Universidad de Zaragoza, Zaragoza, Spain.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Arian', 'Affiliation': 'Physical Therapy, Kuwait Ministry of Health, Safat, Kuwait.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Fernández', 'Affiliation': 'iPhysio Research Group, Universidad San Jorge, Facultad de Ciencias de la Salud, Villanueva de Gallego, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Herrero', 'Affiliation': 'iPhysio Research Group, Universidad San Jorge, Facultad de Ciencias de la Salud, Villanueva de Gallego, Spain pherrero@usj.es.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Bellosta-López', 'Affiliation': 'iPhysio Research Group, Universidad San Jorge, Facultad de Ciencias de la Salud, Villanueva de Gallego, Spain.'}]",BMJ open,['10.1136/bmjopen-2020-038033']
2660,32819960,Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2).,"INTRODUCTION


Self-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the 'SupportBack' internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients.
METHODS AND ANALYSIS


A three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted.
ETHICS AND DISSEMINATION


This trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy.
TRIAL REGISTRATION NUMBER


ISRCTN14736486.",2020,The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design).,"['Patients with current LBP and no indicators of serious spinal pathology', 'primary care', 'primary care patients', 'patients with low back pain (LBP', 'Participants undergo a secondary screen for possible serious spinal pathology']","[""SupportBack' internet intervention, with or without physiotherapist telephone support"", 'internet intervention', 'usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support']","['pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis', 'physical function (using the Roland and Morris Disability Questionnaire', 'LBP-related disability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332149', 'cui_str': 'Possible'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]",,0.160252,The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design).,"[{'ForeName': 'Adam W A', 'Initials': 'AWA', 'LastName': 'Geraghty', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UK A.W.Geraghty@soton.ac.uk.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': 'School of Health Sciences, University of Southampton & University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': 'Department of Psychology, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Hay', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Stuart', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'Keele Clinical Trials Unit, School of Primary, Community and Social Care, Keele University, Keele, Newcastle, UK.'}, {'ForeName': 'Gareth', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Webley', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Durcan', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Alannah', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hughes', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bathers', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Butler-Walley', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Wathall', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Mansell', 'Affiliation': 'School of Life and Health Sciences, Aston University, Birmingham, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Leigh', 'Affiliation': 'Patient and Public Involvement Representative, University of Southampton, Southampton, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, Hampshire, UK.'}]",BMJ open,['10.1136/bmjopen-2020-040543']
2661,32819962,Steroids in COVID-19: An overview.,"Most antiviral or immunomodulatory therapies investigated for use in patients with COVID-19 have failed to show any mortality benefit. Similar to the previous pandemics caused by respiratory viruses, the role and benefit of corticosteroids has been under debate in COVID-19-related pulmonary disease. In this consult, we discuss the evidence regarding the efficacy of corticosteroid use in hospitalized patients with COVID-19, including data from the first randomized controlled trial on this subject.",2020,Most antiviral or immunomodulatory therapies investigated for use in patients with COVID-19 have failed to show any mortality benefit.,"['hospitalized patients with COVID-19', 'Steroids in COVID-19']",['corticosteroid'],[],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",[],,0.0965311,Most antiviral or immunomodulatory therapies investigated for use in patients with COVID-19 have failed to show any mortality benefit.,"[{'ForeName': 'Kshitij', 'Initials': 'K', 'LastName': 'Chatterjee', 'Affiliation': 'Fellow, Department of Pulmonary Medicine, Respiratory Institute, Cleveland Clinic chattek@ccf.org.'}, {'ForeName': 'Chao-Ping', 'Initials': 'CP', 'LastName': 'Wu', 'Affiliation': 'Fellow, Department of Pulmonary Medicine, Respiratory Institute, Cleveland Clinic.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Bhardwaj', 'Affiliation': 'Fellow, Department of Pulmonary Medicine, Respiratory Institute, Cleveland Clinic.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Siuba', 'Affiliation': 'Department of Critical Care Medicine, Respiratory Institute, Cleveland Clinic.'}]",Cleveland Clinic journal of medicine,['10.3949/ccjm.87a.ccc059']
2662,32814339,Effects of Vibration Training in Interstitial Lung Diseases: A Randomized Controlled Trial.,"BACKGROUND


Numerous studies have reported positive effects of exercise training in patients with interstitial lung disease (ILD) on physical capacity and quality of life. However, evidence is rare on the effects of specific forms of training and further pathophysiological mechanisms in these patients.
OBJECTIVES


In this multicenter study we aimed to explore the clinical effects of whole-body vibration training (WBVT) in patients with ILD on various outcome measures, including proinflammatory cytokines and myostatin.
METHODS


We randomly assigned 26 patients with different forms of multidisciplinary confirmed fibrotic ILDs either to the WBVT group (n = 11; 55% male, 61 ± 14 years old, forced vital capacity 83.2 ± 29.3% predicted, 6-min walking distance [6MWD] 478 ± 79 m) performing 3 months of a standardized training (3 times per week), or to a control training group (CTG, n = 15; 60% male, 63 ± 9 years old, FVC 74.6 ± 20.5% predicted, 6MWD 455 ± 85 m) performing sham WBV training. Training in the two groups was performed on a GalileoTM vibration plate (6-20 vs. 5 Hz). The functional assessments before and after the intervention period included pulmonary function, 6MWD test, chair rise test, ultrasonographic measurement of quadriceps muscle thickness (cross-sectional area), quality of life questionnaires, and serum samples.
RESULTS


We observed a significant increase in 6MWD (∆Training = 30 m [12-67], p = 0.024) and a decrease of myostatin (∆Training = -465 pg/mL [-713 to -166], p = 0.008) in the WBVT group. In contrast, no significant differences were observed in the CTG.
CONCLUSIONS


The present study demonstrates that WBVT is able to significantly increase 6MWD and decrease myostatin in patients with fibrotic ILDs. Therefore, WBVT seems to be a beneficial and feasible training modality in ILD patients. Clinical Trial Registry: German Clinical Trials Registry (DRKS00012930).",2020,"We observed a significant increase in 6MWD (∆Training = 30 m [12-67], p = 0.024) and a decrease of myostatin (∆Training = -465 pg/mL","['Interstitial Lung Diseases', 'ILD patients', '26 patients with different forms of multidisciplinary confirmed fibrotic ILDs either to the WBVT group (n = 11; 55% male, 61 ± 14 years old, forced vital capacity 83.2 ± 29.3% predicted, 6-min walking distance', 'patients with interstitial lung disease (ILD', 'patients with fibrotic ILDs', 'patients with ILD']","['WBVT', 'exercise training', 'control training', 'GalileoTM vibration plate', 'whole-body vibration training (WBVT', 'sham WBV training', 'Vibration Training']","['pulmonary function, 6MWD test, chair rise test, ultrasonographic measurement of quadriceps muscle thickness (cross-sectional area), quality of life questionnaires, and serum samples', 'proinflammatory cytokines and myostatin', '6MWD']","[{'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0538238', 'cui_str': 'GDF8 protein, human'}]",26.0,0.0300793,"We observed a significant increase in 6MWD (∆Training = 30 m [12-67], p = 0.024) and a decrease of myostatin (∆Training = -465 pg/mL","[{'ForeName': 'Andreas Rembert', 'Initials': 'AR', 'LastName': 'Koczulla', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Boeselt', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Koelpin', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Kaufhold', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Veith', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nell', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Jarosch', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany, ijarosch@schoen-klinik.de.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Spielmanns', 'Affiliation': 'Pulmonology, Zuercher Reha Zentrum Wald, Wald, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Alter', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kähler', 'Affiliation': 'Pneumology SKB, Private Clinic Kettenbruecke, Innsbruck, Austria.'}, {'ForeName': 'Timm', 'Initials': 'T', 'LastName': 'Greulich', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Claus F', 'Initials': 'CF', 'LastName': 'Vogelmeier', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Glöckl', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Schneeberger', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Kenn', 'Affiliation': 'Philipps-University of Marburg/Institute for Internal Medicine, Department of Pulmonology, Marburg, Germany.'}, {'ForeName': 'Nicolas Carlos', 'Initials': 'NC', 'LastName': 'Kahn', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Felix J F', 'Initials': 'FJF', 'LastName': 'Herth', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Pneumology, Thoraxklinik University of Heidelberg, Heidelberg, Germany.'}]",Respiration; international review of thoracic diseases,['10.1159/000508977']
2663,32814460,"Changes in ET-1, Plasma Neuropeptide Y, and CGRP in Child Patients With Congenital Heart Disease Complicated With Pulmonary Hypertension Before and After Operation.","This study aims to explore the changes in endothelin-1 (ET-1), plasma neuropeptide Y, and calcitonin gene-related peptide (CGRP) in child patients before and after operation. A total of 80 child patients with congenital heart disease (CHD) complicated with pulmonary hypertension (PH) were enrolled and divided into control group (n = 40, conservative treatment for various reasons) and observation group (n = 40, active preoperative preparation and timely operative intervention) according to different treatments. There were positive correlations between systolic pulmonary arterial pressure (sPAP) and ET-1, plasma neuropeptide Y, while negative correlation between sPAP and CGRP. In conclusion, our data demonstrate that the levels of ET-1, plasma neuropeptide Y, and CGRP in PH-CHD were significantly changed after interventions, which provides new leads as alternative biomarkers to assess the efficacy of treatments against PH-CHD.",2020,"There were positive correlations between systolic pulmonary arterial pressure (sPAP) and ET-1, plasma neuropeptide Y, while negative correlation between sPAP and CGRP.","['Child Patients With Congenital Heart Disease Complicated With Pulmonary Hypertension', 'child patients before and after operation', '80 child patients with congenital heart disease (CHD) complicated with pulmonary hypertension (PH']","['conservative treatment for various reasons) and observation group (n = 40, active preoperative preparation and timely operative intervention']","['levels of ET-1, plasma neuropeptide Y, and CGRP in PH-CHD', 'systolic pulmonary arterial pressure (sPAP) and ET-1, plasma neuropeptide Y', 'Changes in ET-1, Plasma Neuropeptide Y, and CGRP', 'endothelin-1 (ET-1), plasma neuropeptide Y, and calcitonin gene-related peptide (CGRP']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0459914', 'cui_str': 'Conservative therapy'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0027893', 'cui_str': 'Neuropeptide Y'}, {'cui': 'C0006669', 'cui_str': 'Calcitonin gene-related peptide'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1168098', 'cui_str': 'Pulmonary arterial pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",80.0,0.0215145,"There were positive correlations between systolic pulmonary arterial pressure (sPAP) and ET-1, plasma neuropeptide Y, while negative correlation between sPAP and CGRP.","[{'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang Uygur Autonomous Region, China.'}, {'ForeName': 'Mingming', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang Uygur Autonomous Region, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Huo', 'Affiliation': 'The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang Uygur Autonomous Region, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'The First Affiliated Hospital of Xinjiang Medical University, Urumqi, Xinjiang Uygur Autonomous Region, China.'}]",Clinical pediatrics,['10.1177/0009922820948261']
2664,32814461,"Anifrolumab, a Monoclonal Antibody to the Type I Interferon Receptor Subunit 1, for the Treatment of Systemic Lupus Erythematosus: An Overview From Clinical Trials.","Chronic activation of the type I interferon (IFN) pathway plays a critical role in systemic lupus erythematosus (SLE) pathogenesis. Anifrolumab is a human monoclonal antibody to the type I IFN receptor subunit 1, which blocks the action of type I IFNs. Two phase 3 studies (TULIP-1 and TULIP-2) and a phase 2b study (MUSE) provide substantial evidence for the efficacy and safety of anifrolumab for moderately to severely active SLE. In all 3 studies, monthly intravenous anifrolumab 300 mg was associated with treatment differences >16% compared with placebo at Week 52 in British Isles Lupus Assessment Group-based Composite Lupus Assessment response rates. The combined data across a range of other clinically significant endpoints (e.g., oral corticosteroid reduction, improved skin disease, flare reduction) further support the efficacy of anifrolumab for SLE treatment. The safety profile of anifrolumab was generally similar across all studies; serious adverse events occurred in 8%-16% and 16%-19% of patients receiving anifrolumab and placebo, respectively. Herpes zoster incidence was greater with anifrolumab (≤7%) vs placebo (≤2%). Evidence from these clinical trials suggests that in patients with active SLE, anifrolumab is superior to placebo in achieving composite endpoints of disease activity response and oral corticosteroid reduction.",2020,Herpes zoster incidence was greater with anifrolumab (≤7%) vs placebo (≤2%).,['Systemic Lupus Erythematosus'],['placebo'],"['safety profile of anifrolumab', 'serious adverse events', 'Herpes zoster incidence', 'skin disease, flare reduction']","[{'cui': 'C0024141', 'cui_str': 'Systemic lupus erythematosus'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4519739', 'cui_str': 'anifrolumab'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019360', 'cui_str': 'Herpes zoster'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0037274', 'cui_str': 'Disorder of skin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.282096,Herpes zoster incidence was greater with anifrolumab (≤7%) vs placebo (≤2%).,"[{'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan;'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Tummala', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.'}]",Modern rheumatology,['10.1080/14397595.2020.1812201']
2665,32814489,Visibility and image quality of peripheral pulmonary arteries in pulmonary embolism patients using free-breathing combined with a high-threshold bolus-triggering technique in CT pulmonary angiography.,"OBJECTIVE


To investigate the visibility of peripheral pulmonary arteries by computed tomography pulmonary angiography (CTPA) and image quality using a free-breathing combined with a high-threshold bolus triggering technique and to explore the feasibility of this technique in pulmonary embolism (PE) patients who cannot hold their breath.
METHODS


Patients with suspected PE who underwent CTPA (n=240) were randomly assigned to two groups: free-breathing (n=120) or breath-holding (n=120).
RESULTS


The mean scanning time or visible pulmonary artery distal branches were not different between the groups. Mean CT main pulmonary artery (MPA) values, apical segment (S1), and posterior basal segment (S10) in the free-breathing group were higher compared with the breath-holding group. The subjective image quality score in the free-breathing group was higher compared with the breath-holding group. In the free-breathing group, no respiratory artifact was observed. In the breath-holding group, obvious respiratory artifacts were caused by severe chronic obstructive pulmonary disease (COPD), dyspnea, or other diseases that preclude patients from holding their breath.
CONCLUSION


The free-breathing mode CTPA combined with a high-threshold bolus triggering technique can provide high quality images with a lower incidence of respiratory and cardiac motion artifacts, which is especially valuable for patients who cannot hold their breath.",2020,The subjective image quality score in the free-breathing group was higher compared with the breath-holding group.,"['Patients with suspected PE who underwent CTPA (n=240', 'pulmonary embolism patients', 'patients who cannot hold their breath', 'pulmonary embolism (PE) patients who cannot hold their breath']","['computed tomography pulmonary angiography (CTPA', 'free-breathing (n=120) or breath-holding', 'free-breathing combined with a high-threshold bolus-triggering technique in CT pulmonary angiography']","['severe chronic obstructive pulmonary disease (COPD), dyspnea', 'mean scanning time or visible pulmonary artery distal branches', 'Visibility and image quality of peripheral pulmonary arteries', 'Mean CT main pulmonary artery (MPA) values, apical segment (S1), and posterior basal segment (S10', 'subjective image quality score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1563135', 'cui_str': 'Suspected pulmonary embolism'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0677490', 'cui_str': 'Angiogram pulmonary'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0235744', 'cui_str': 'Interrupted breathing'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0677490', 'cui_str': 'Angiogram pulmonary'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0032930', 'cui_str': 'Precipitating Factors'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0730607', 'cui_str': 'Severe chronic obstructive pulmonary disease'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",240.0,0.0266987,The subjective image quality score in the free-breathing group was higher compared with the breath-holding group.,"[{'ForeName': 'Daliang', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': ""Department of Radiology, Liaocheng People's Hospital, Liaocheng, Shandong, P. R. China.""}, {'ForeName': 'Xiansheng', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': ""Department of Radiology, Liaocheng People's Hospital, Liaocheng, Shandong, P. R. China.""}, {'ForeName': 'Xiaoshuang', 'Initials': 'X', 'LastName': 'Che', 'Affiliation': ""Department of Radiology, Liaocheng People's Hospital, Liaocheng, Shandong, P. R. China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': ""Department of Radiology, Liaocheng People's Hospital, Liaocheng, Shandong, P. R. China.""}, {'ForeName': 'Yucun', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': ""Department of Radiology, Liaocheng People's Hospital, Liaocheng, Shandong, P. R. China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Department of Radiology, Liaocheng People's Hospital, Liaocheng, Shandong, P. R. China.""}]",The Journal of international medical research,['10.1177/0300060520939326']
2666,32814640,"Assessment of indirect protection from maternal influenza immunization among non-vaccinated household family members in a randomized controlled trial in Sarlahi, Nepal.","Influenza is a significant cause of morbidity and mortality worldwide, and the World Health Organization highly recommends maternal vaccination during pregnancy. The indirect effect of maternal vaccination on other close contacts other than newborns is unknown. To evaluate this, we conducted a nested substudy between 2011 and 2012 of influenza and acute respiratory illness (ARI) among household members of pregnant women enrolled in a randomized placebo-controlled trial of antenatal influenza vaccination in the rural district of Sarlahi, Nepal. Women were assigned to receive influenza vaccination or placebo during pregnancy and then they and their household members were followed up to 6 months postpartum with weekly symptom surveillance and nasal swab collection. Swabs were tested by RT-PCR for influenza. Rates of laboratory-confirmed influenza and of ARI were compared between vaccine and placebo groups using generalized estimating equations with a Poisson link function. Overall, 1752 individuals in 520 households were eligible for inclusion. There were 82 laboratory-confirmed influenza illness episodes, for a rate of 7.0 per 100 person-years overall. Of the influenza strains able to be typed, 29 were influenza A, 40 were influenza B, and 6 were coinfections with influenza A and B. The rate did not differ significantly whether the household was in the vaccine or placebo group (rate ratio (RR) 1.37, 95% confidence interval (CI) 0.83-2.26). The rate of ARI was 28.5 per 100 person-years overall and did not differ by household group (RR 0.99, 95% CI 0.72-1.36). Influenza vaccination of pregnant women did not provide indirect protection of unvaccinated household members.",2020,"The rate of ARI was 28.5 per 100 person-years overall and did not differ by household group (RR 0.99, 95% CI 0.72-1.36).","['non-vaccinated household family members', 'unvaccinated household members', 'nested substudy between 2011 and 2012 of influenza and acute respiratory illness (ARI) among household members of pregnant women enrolled in a randomized', 'in the rural district of Sarlahi, Nepal', '1752 individuals in 520 households were eligible for inclusion', 'pregnant women']","['antenatal influenza vaccination', 'indirect protection from maternal influenza immunization', 'influenza vaccination or placebo', 'placebo']","['rate ratio (RR', 'rate of ARI']","[{'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0027689', 'cui_str': 'Nepal'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4517803', 'cui_str': '520'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0221423', 'cui_str': 'Illness'}]",520.0,0.63193,"The rate of ARI was 28.5 per 100 person-years overall and did not differ by household group (RR 0.99, 95% CI 0.72-1.36).","[{'ForeName': 'Kira L', 'Initials': 'KL', 'LastName': 'Newman', 'Affiliation': 'School of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Laveta M', 'Initials': 'LM', 'LastName': 'Stewart', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Scott', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Denver, CO, USA.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, DC, USA.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Englund', 'Affiliation': ""Seattle Children's Hospital and Research Foundation, University of Washington, Seattle, WA, USA.""}, {'ForeName': 'Subarna K', 'Initials': 'SK', 'LastName': 'Khatry', 'Affiliation': 'Nepal Nutrition Intervention Project, Sarlahi, Kathmandu, Nepal.'}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Mullany', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'LeClerq', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Nepal Nutrition Intervention Project, Sarlahi, Kathmandu, Nepal.'}, {'ForeName': 'Laxman', 'Initials': 'L', 'LastName': 'Shrestha', 'Affiliation': 'Tribhuvan University, Department of Pediatrics and Child Health, Institute of Medicine, Kathmandu, Nepal.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Kuypers', 'Affiliation': 'School of Medicine, University of Washington, Molecular Virology Laboratory, Seattle, WA, USA.'}, {'ForeName': 'Helen Y', 'Initials': 'HY', 'LastName': 'Chu', 'Affiliation': 'School of Medicine, University of Washington, Seattle, WA, USA. Electronic address: helenchu@uw.edu.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Katz', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}]",Vaccine,['10.1016/j.vaccine.2020.08.014']
2667,32814658,"The low power effect on holmium laser enucleation of prostate (HoLEP); A comparison between 20W and 37,5W energy regarding apical enucleation efficacy and patient safety.","INTRODUCTION


The Holmium laser has proven to be an invaluable tool for endoscopic prostate enucleation. The proper energy selection, during the different steps of the procedure, has always been a matter of debate. In this work we compare the effectiveness of the Holmium laser, using two different low-power energy settings, during enucleation and hemostasis (20W and 37.5W).
METHODS


One hundred and sixty patients underwent a HoLEP procedure with a 50Hz and 2J (100W) setting. During enuleation and hemostasis, two different low-power settings were applied (20W vs. 37.5W). In both groups, only the prostatic tissue in the bladder neck and enucleated tissue far away from the apex, were cut with a setting of 50Hz and 2J (100W).
RESULTS


The mean enucleation efficiency (0.78 vs. 1.2g/min-p:001) was significantly higher by utilizing 37.5W energy (group 2). Additionally, the mean enucleation rate (0.64 vs. 0.88%-P:0.001) and laser efficiency (2.07 vs. 2.12 joule/g-P:0.003) were significantly higher in group 2. The enucleation time was significantly shorter (54 vs. 75.5 mins-P:0.002), while the mean catheter removal time (27 vs. 42 hrs-P:0.008) and Hb decrease (0.5 vs. 0.6g/dl--P:0.019) were significantly lower in group 2.
CONCLUSIONS


HoLEP can be performed efficiently with 100 W-37.5W settings. Enucleation and hemostasis can be performed successfully with 37.5W, while the use of 100W during bladder neck dissection shortens the duration of the procedure.
LEVEL OF EVIDENCE


3.",2020,"The enucleation time was significantly shorter (54 vs. 75.5 mins-P:0.002), while the mean catheter removal time (27 vs. 42 hrs-P:0.008) and Hb decrease (0.5 vs. 0.6g/dl--P:0.019) were significantly lower in group 2.
",['One hundred and sixty patients underwent a HoLEP procedure with a 50Hz and 2J (100W) setting'],"['holmium laser enucleation of prostate (HoLEP', 'Holmium laser']","['laser efficiency', 'mean enucleation rate', 'mean enucleation efficiency', 'mean catheter removal time', 'enucleation time']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C3698057', 'cui_str': 'Holmium laser enucleation of prostate'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0014392', 'cui_str': 'Enucleation'}, {'cui': 'C0394884', 'cui_str': 'Removal of catheter'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",160.0,0.0354903,"The enucleation time was significantly shorter (54 vs. 75.5 mins-P:0.002), while the mean catheter removal time (27 vs. 42 hrs-P:0.008) and Hb decrease (0.5 vs. 0.6g/dl--P:0.019) were significantly lower in group 2.
","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gazel', 'Affiliation': 'Acibadem University Ankara Hospital, Department of Urology, Ankara, Turkey. Electronic address: eymen_gazel@yahoo.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kaya', 'Affiliation': 'Gulhane Training and Research Hospital, Department of Urology, Ankara, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yalcın', 'Affiliation': 'Gulhane Training and Research Hospital, Department of Urology, Ankara, Turkey.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Tokas', 'Affiliation': 'General Hospital Hall i.T., Hall in Tirol, Department of Urology and Andrology, Austria.'}, {'ForeName': 'H C', 'Initials': 'HC', 'LastName': 'Aybal', 'Affiliation': 'Ankara Oncology Training and Research Hospital, Department of Urology, Ankara, Turkey.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yılmaz', 'Affiliation': 'Gulhane Training and Research Hospital, Department of Urology, Ankara, Turkey.'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Aydogan', 'Affiliation': 'Goksun State Hospital, Department of Urology, Kahramanmaras, Turkey.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tunc', 'Affiliation': 'Gazi University School of Medicine, Department of Urology, Ankara, Turkey.'}]",Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie,['10.1016/j.purol.2020.05.009']
2668,32814667,"Efficacy, safety, and parental anxiety in a randomized trial of two dietary instruction methods for children with suspected hen's egg allergy.","BACKGROUND


Little has been reported on how to introduce hen's egg into the diet of children with suspected egg allergy. We compared the efficacy, safety, and parental anxiety of two different dietary instruction methods to introduce egg.
METHODS


Eligible participants were children aged 1-4 years who were positive for egg white IgE, and ovomucoid IgE <3.5 kUA/L. Participants were either naïve in egg consumption or had a history of an immediate, but non-anaphylactic, allergic reaction to egg. After a negative result of baseline 2 g boiled egg white oral food challenge (OFC), participants were randomly assigned to the step-up OFC testing (SOFT) or home incrementing group. The primary outcome was the proportion of participants who were able to ingest 20 g of boiled egg white 6 months after initiation. This study is registered with the University Hospital Medical Information Network clinical trial registry (UMIN000024192).
RESULTS


Between September 2016 and August 2018, we randomly allocated 55 participants to the SOFT (n = 33 [60%]) and home incrementing (n = 22 [40%]) groups and analyzed 51 patients. Four patients were excluded because they were lost to follow-up. Thirty-one (96.9%) of 32 participants in the SOFT and 12 (63.2%) of 19 in the home incrementing group achieved the primary outcome (p = 0.003). No serious adverse reactions were observed in either group. Parental anxiety significantly improved during treatment in both groups.
CONCLUSIONS


The SOFT method was more effective than home incrementing as dietary instruction to introduce egg in children with suspected egg allergy.",2020,No serious adverse reactions were observed in either group.,"['children with suspected egg allergy', 'Between September 2016 and August 2018', 'groups and analyzed 51 patients', 'n\xa0=\xa022', ""children with suspected hen's egg allergy"", 'Eligible participants were children aged 1-4 years who were positive for egg white IgE, and ovomucoid IgE <3.5\xa0kUA/L. Participants were either naïve in egg consumption or had a history of an immediate, but non-anaphylactic, allergic reaction to egg']","['boiled egg white oral food challenge (OFC', 'SOFT', 'step-up OFC testing (SOFT) or home incrementing group', 'home incrementing ']","['serious adverse reactions', 'Parental anxiety', 'Efficacy, safety, and parental anxiety', 'efficacy, safety, and parental anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0559469', 'cui_str': 'Allergy to edible egg'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0440466', 'cui_str': ""Hen's egg""}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0013704', 'cui_str': 'Egg white'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0029960', 'cui_str': 'Ovomucin'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C0452824', 'cui_str': 'Boiled egg'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C1861537', 'cui_str': 'Orofacial Cleft 1'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0577602', 'cui_str': 'Parental anxiety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",4.0,0.122884,No serious adverse reactions were observed in either group.,"[{'ForeName': 'Katsumasa', 'Initials': 'K', 'LastName': 'Kitamura', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Aichi, Japan. Electronic address: katsumasa_kitamura@sk00106.achmc.pref.aichi.jp.""}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Sakai', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Aichi, Japan.""}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Sasaki', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Aichi, Japan.""}, {'ForeName': 'Teruaki', 'Initials': 'T', 'LastName': 'Matsui', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Aichi, Japan.""}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Takasato', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Aichi, Japan.""}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Sugiura', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Aichi, Japan.""}, {'ForeName': 'Komei', 'Initials': 'K', 'LastName': 'Ito', 'Affiliation': ""Department of Allergy, Aichi Children's Health and Medical Center, Aichi, Japan.""}]",Allergology international : official journal of the Japanese Society of Allergology,['10.1016/j.alit.2020.07.007']
2669,32815077,The Effect of a General Healthy Lifestyle Intervention Delivered Around Pregnancy on Gestational Weight Gain and Infant Growth.,"OBJECTIVES


A life-course perspective emphasizes healthy behaviors before, during, and after pregnancy to support a multi-generational risk reduction in obesity for mothers and infants. Optimal timing, content, and dose of such interventions is not well defined.
METHODS


We conducted a nested cohort within a randomized trial to evaluate whether a healthy lifestyle intervention around pregnancy led to a ""spill-over effect,"" including a healthier rate (kg/week) of maternal gestational weight gain, and infant growth during the first year. Study enrollment began in 2012, follow-up data collection completed in 2018, and the data were analyzed in 2019. The intervention focused on healthy maternal diet and physical activity but not pregnancy weight or infant feeding. Outcome data were abstracted from electronic medical records.
RESULTS


Of the 165 women who became pregnant, 114 enrolled in the nested cohort. The average pre-pregnancy BMI was 29.6 (SD 5.1) kg/m 2 . Mixed effects models suggested clinically insignificant differences in both the rate of gestational weight gain (-0.02 kg/week; 95% CI -0.09, 0.06) and the rate of infant growth (difference at 1 year: -0.002 kg/cm; 95% CI -0.009, 0.005).
CONCLUSIONS FOR PRACTICE


A behavioral intervention that focused on overall maternal health delivered in the time around pregnancy did not result in a ""spill-over effect"" on healthy gestational weight gain or healthy infant growth during the first year of life.
TRIAL REGISTRATION


This study is registered at www.clinicaltrials.gov NCT01316653.",2020,"Mixed effects models suggested clinically insignificant differences in both the rate of gestational weight gain (-0.02 kg/week; 95% CI -0.09, 0.06) and the rate of infant growth (difference at 1 year: -0.002 kg/cm; 95% CI -0.009, 0.005).
","['165 women who became pregnant', 'Study enrollment began in 2012, follow-up data collection completed in 2018, and the data were analyzed in 2019', 'mothers and infants', '114 enrolled in the nested cohort']","['General Healthy Lifestyle Intervention Delivered Around Pregnancy', 'healthy lifestyle intervention', 'healthy maternal diet and physical activity but not pregnancy weight or infant feeding']","['rate of gestational weight gain', 'maternal gestational weight gain, and infant growth', 'healthy gestational weight gain or healthy infant growth', 'Gestational Weight Gain and Infant Growth', 'average pre-pregnancy BMI', 'rate of infant growth', 'overall maternal health']","[{'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024921', 'cui_str': 'Maternal Health'}]",,0.301696,"Mixed effects models suggested clinically insignificant differences in both the rate of gestational weight gain (-0.02 kg/week; 95% CI -0.09, 0.06) and the rate of infant growth (difference at 1 year: -0.002 kg/cm; 95% CI -0.009, 0.005).
","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Heerman', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, 2146 Belcourt Ave, 2nd Floor, Nashville, TN, 37212, USA. Bill.Heerman@vumc.org.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Samuels', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Barr', 'Affiliation': 'Vanderbilt University Medical School, Nashville, TN, USA.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Burgess', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, 2146 Belcourt Ave, 2nd Floor, Nashville, TN, 37212, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Hartmann', 'Affiliation': 'Department of Obstetrics and Gynecology, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Shari L', 'Initials': 'SL', 'LastName': 'Barkin', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, 2146 Belcourt Ave, 2nd Floor, Nashville, TN, 37212, USA.'}]",Maternal and child health journal,['10.1007/s10995-020-02998-0']
2670,32815101,Simultaneous en bloc endotracheal tube insertion with GlideScope® Titanium™ video laryngoscope use: a randomized-controlled trial.,"PURPOSE


Intubation-associated trauma with the GlideScope is rare, but when it occurs, it is likely due to advancing the endotracheal tube (ETT) blindly between the direct view of the oropharynx and the video view of the glottis. It is also occasionally difficult to advance the ETT to the glottic aperture despite a good view of the glottis on the monitor. One technique to potentially address both issues is to introduce the ETT en bloc with the GlideScope, thus visualizing the ETT tip throughout its entire path. We hypothesized that this en bloc technique could be faster and potentially easier than the standard technique.
METHODS


Fifty patients with normal-appearing airways who required orotracheal intubation for elective surgery were randomly allocated to intubation with either the en bloc or the standard (GlideScope-first-then-ETT) technique. A three-dimensional printed clip was utilized to secure the ETT to the GlideScope during en bloc insertion. The primary outcome was time to intubation, defined from mask removal to first end-tidal carbon dioxide detection, recorded by a blinded observer. Secondary outcomes were subjective ease of intubation (100-mm visual analogue scale [VAS], 0 = easy; 100 = difficult), number of intubation attempts/failures, and incidence of oropharyngeal trauma (bleeding).
RESULTS


The median [interquartile range (IQR)] intubation time was 36 [31-42] sec with the en bloc technique vs 41 [37-50] sec with the standard technique (difference in medians, 5 sec; 95% confidence interval [CI], 2 to 11; P = 0.008). The median [IQR] ease of intubation VAS was 11 [9-21] mm with the en bloc technique, and 15 [11-24] mm with the standard technique (difference in medians, 4 mm; 95% CI, -2 to 8; P = 0.19). Laryngoscopic grade and number of intubation attempts were similar between the groups; there was no oropharyngeal trauma noted.
CONCLUSION


In this study of video laryngoscopy, intubation was slightly faster with the en bloc technique than with the standard GlideScope intubation technique, although the clinical importance of this difference is unknown.
TRIAL REGISTRATION


www.clinicaltrials.gov (NCT02787629); registered 1 June 2016.",2020,"In this study of video laryngoscopy, intubation was slightly faster with the en bloc technique than with the standard GlideScope intubation technique, although the clinical importance of this difference is unknown.
",['Fifty patients with normal-appearing airways who required orotracheal intubation for elective surgery'],"['intubation with either the en bloc or the standard (GlideScope-first-then-ETT) technique', 'Simultaneous en bloc endotracheal tube insertion with GlideScope® Titanium']","['time to intubation, defined from mask removal to first end-tidal carbon dioxide detection', 'Laryngoscopic grade and number of intubation attempts', 'median [IQR] ease of intubation VAS', 'subjective ease of intubation (100-mm visual analogue scale [VAS], 0 = easy; 100 = difficult), number of intubation attempts/failures, and incidence of oropharyngeal trauma (bleeding', 'median [interquartile range (IQR', 'intubation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0396621', 'cui_str': 'Orotracheal intubation'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",50.0,0.120902,"In this study of video laryngoscopy, intubation was slightly faster with the en bloc technique than with the standard GlideScope intubation technique, although the clinical importance of this difference is unknown.
","[{'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Turkstra', 'Affiliation': 'Department of Anesthesia & Perioperative Medicine, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Turkstra', 'Affiliation': 'Department of Mechanical Engineering, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Alexander W', 'Initials': 'AW', 'LastName': 'Pavlosky', 'Affiliation': 'Department of Family Medicine, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Jones', 'Affiliation': 'Department of Anesthesia & Perioperative Medicine, Schulich School of Medicine & Dentistry, University of Western Ontario, London, ON, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-020-01778-2']
2671,32815175,Blinded continuous information monitoring of recurrent event endpoints with time trends in clinical trials.,"Blinded sample size re-estimation and information monitoring based on blinded data has been suggested to mitigate risks due to planning uncertainties regarding nuisance parameters. Motivated by a randomized controlled trial in pediatric multiple sclerosis (MS), a continuous monitoring procedure for overdispersed count data was proposed recently. However, this procedure assumed constant event rates, an assumption often not met in practice. Here we extend the procedure to accommodate time trends in the event rates considering two blinded approaches: (a) the mixture approach modeling the number of events by a mixture of two negative binomial distributions and (b) the lumping approach approximating the marginal distribution of the event counts by a negative binomial distribution. Through simulations the operating characteristics of the proposed procedures are investigated under decreasing event rates. We find that the type I error rate is not inflated relevantly by either of the monitoring procedures, with the exception of strong time dependencies where the procedure assuming constant rates exhibits some inflation. Furthermore, the procedure accommodating time trends has generally favorable power properties compared with the procedure based on constant rates which stops often too late. The proposed method is illustrated by the clinical trial in pediatric MS.",2020,"We find that the type I error rate is not inflated relevantly by either of the monitoring procedures, with the exception of strong time dependencies where the procedure assuming constant rates exhibits some inflation.",['pediatric multiple sclerosis (MS'],[],[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]",[],[],,0.103789,"We find that the type I error rate is not inflated relevantly by either of the monitoring procedures, with the exception of strong time dependencies where the procedure assuming constant rates exhibits some inflation.","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Mütze', 'Affiliation': 'Statistical Methodology, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Salem', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Benda', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Schmidli', 'Affiliation': 'Statistical Methodology, Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Friede', 'Affiliation': 'Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.'}]",Statistics in medicine,['10.1002/sim.8702']
2672,32815384,"Effectiveness of dry needling for upper extremity spasticity, quality of life and function in subacute phase stroke patients.","BACKGROUND


Stroke is the fourth leading cause of death in Europe, represents one of the most common causes of disability in adult patients, and involves considerable short- and long-term social and healthcare costs. The effectiveness of deep dry needling (DDN) on affected arm functionality was assessed throughout 8 weeks of treatment in patients with stroke in the subacute phase.
METHODS


Eighty patients were included in this two-group non-randomised study after a propensity score analysis was carried out. Both groups received standard physiotherapy treatment on the affected arm. The needling group also received six sessions of DDN during the 8-week period. Patients were evaluated before and after each session using the Fugl-Meyer upper extremity (FM UE) scale, the modified modified Ashworth scale (MMAS), the resistance to passive movement scale (REPAS) and a 10-point numeric pain rating scale (NPRS 10). The Brunnstrom recovery stage was recorded at the beginning and at the end of the study, and the EuroQoL quality of life survey was completed at the beginning of the study, after the first month of treatment and at the end of the study.
RESULTS


Patients treated with DDN showed a reduction in spasticity measured using the REPAS (p < 0.001) and the MMAS (p < 0.05). There was also an improvement in the Brunnstrom recovery stages (p < 0.05).
CONCLUSION


The addition of a specific DDN treatment to a standard physiotherapy treatment appeared to lead to a higher reduction in spasticity in the affected arm; however, it did not provide additional changes in functionality, pain and quality of life. Further studies with a randomised controlled trial design are required to confirm our findings.",2020,"RESULTS


Patients treated with DDN showed a reduction in spasticity measured using the REPAS (p < 0.001) and the MMAS (p < 0.05).","['patients with stroke in the subacute phase', 'Eighty patients were included in this two-group non-randomised study after a propensity score analysis was carried out', 'subacute phase stroke patients']","['dry needling', 'deep dry needling (DDN', 'standard physiotherapy treatment']","['Fugl-Meyer upper extremity (FM UE) scale, the modified modified Ashworth scale (MMAS), the resistance to passive movement scale (REPAS) and a 10-point numeric pain rating scale (NPRS 10', 'functionality, pain and quality of life', 'Brunnstrom recovery stages', 'upper extremity spasticity, quality of life and function', 'reduction in spasticity', 'EuroQoL quality of life survey']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0079991', 'cui_str': 'Passive movement'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",80.0,0.0621348,"RESULTS


Patients treated with DDN showed a reduction in spasticity measured using the REPAS (p < 0.001) and the MMAS (p < 0.05).","[{'ForeName': 'Juan Nicolás', 'Initials': 'JN', 'LastName': 'Cuenca Zaldívar', 'Affiliation': 'Rehabilitation Service, Guadarrama Hospital, Guadarrama, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Calvo', 'Affiliation': 'School of Health Sciences, San Jorge University, Zaragoza, Spain.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bravo-Esteban', 'Affiliation': 'School of Health Sciences, San Jorge University, Zaragoza, Spain.'}, {'ForeName': 'Petronila', 'Initials': 'P', 'LastName': 'Oliva Ruiz', 'Affiliation': 'School of Health Sciences, Institute of Research and Innovation in Biomedical Sciences of the Province of Cadiz (INiBICA), University of Cádiz, Cádiz, Spain.'}, {'ForeName': 'Maria José', 'Initials': 'MJ', 'LastName': 'Santi-Cano', 'Affiliation': 'School of Health Sciences, Institute of Research and Innovation in Biomedical Sciences of the Province of Cadiz (INiBICA), University of Cádiz, Cádiz, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Herrero', 'Affiliation': 'School of Health Sciences, San Jorge University, Zaragoza, Spain.'}]",Acupuncture in medicine : journal of the British Medical Acupuncture Society,['10.1177/0964528420947426']
2673,32815648,A multicenter clinical trial to assess the efficacy of the digital therapeutics for essential hypertension: Rationale and design of the HERB-DH1 trial.,"Digital therapeutics is a new approach to treat hypertension via using software programs such as smartphone apps and/or device algorithms. We develop a HERB system-new interactive smartphone app (HERB Mobile) with web-based patient management console (HERB Console)-to lower blood pressure (BP) based on an algorithm that helps users to promote lifestyle modifications in conjunction with medically validated non-pharmacological interventions. The app can assess the personalities, behavior characteristics, and hypertension determinants of each patient with hypertension to provide adequate guidance. To demonstrate the efficacy of the system, we designed a randomized, controlled, multicenter, open-label trial ""HERB-DH1 (HERB digital hypertension 1)"" to assess the efficacy of HERB system in patients with essential hypertension. The authors allocate patients to the intervention group (HERB system + standard lifestyle modification) or to the control group (standard lifestyle modification alone). In the intervention group, we provide the HERB Mobile for patients and the HERB Console for their primary physicians for 24 weeks. Both groups are instructed for standard lifestyle modifications based on the current recommendations in the Japanese Society of Hypertension 2019 guideline. The primary outcome is the mean change from baseline to 12 weeks in 24-hour systolic BP measured by ambulatory BP monitoring. We started this study in December of 2019, and the trial results will be expected in early 2021. We believe that this trial enables us to verify the efficacy of the HERB system in patients with essential hypertension.",2020,The primary outcome is the mean change from baseline to 12 weeks in 24-hour systolic BP measured by ambulatory BP monitoring.,['patients with essential hypertension'],"['intervention group (HERB system\xa0+\xa0standard lifestyle modification) or to the control group (standard lifestyle modification alone', 'HERB system-new interactive smartphone app (HERB Mobile) with web-based patient management console (HERB Console)-to lower blood pressure (BP', 'HERB Mobile']",['mean change from baseline to 12\xa0weeks in 24-hour systolic BP measured by ambulatory BP monitoring'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C3873699', 'cui_str': 'Console'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1282174', 'cui_str': '24 hour systolic blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}]",,0.0486544,The primary outcome is the mean change from baseline to 12 weeks in 24-hour systolic BP measured by ambulatory BP monitoring.,"[{'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Kario', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Nomura', 'Affiliation': 'CureApp Institute, Karuizawa, Japan.'}, {'ForeName': 'Noriko', 'Initials': 'N', 'LastName': 'Harada', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Tanigawa', 'Affiliation': 'CureApp Institute, Karuizawa, Japan.'}, {'ForeName': 'Ryuhei', 'Initials': 'R', 'LastName': 'So', 'Affiliation': 'CureApp, Inc, Tokyo, Japan.'}, {'ForeName': 'Kiyose', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'CureApp, Inc, Tokyo, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'CureApp, Inc, Tokyo, Japan.'}, {'ForeName': 'Ayako', 'Initials': 'A', 'LastName': 'Okura', 'Affiliation': 'Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Tochigi, Japan.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Hida', 'Affiliation': 'Department of Biostatistics and Data Science, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kohta', 'Initials': 'K', 'LastName': 'Satake', 'Affiliation': 'CureApp Institute, Karuizawa, Japan.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13993']
2674,32815661,Pharmacological treatment of high-normal blood pressure (prehypertension) in high-risk patients for primary prevention of cardiovascular events.,"Currently, the best treatment strategy for patients with a high-normal blood pressure (prehypertension) is not known. The authors aimed to determine whether pharmacological reduction of systolic blood pressure (SBP) to a normal level (<120 mm Hg) would prevent cardiac morbidity and mortality in prehypertensive patients. In this secondary analysis, the authors obtained the data from SPRINT from the National Heart, Lung, and Blood Institute data repository center. Among 9361 patients enrolled in SPRINT, 289 high-risk (ASCVD risk = 24.8% ± 13.0 [10-65]) prehypertensive patients without previous cardiovascular disease and not receiving any antihypertensive medications were enrolled. One hundred and forty-eight of them were assigned to standard treatment which consisted of clinical follow-up till SBP goes above 140 mm Hg and then staring medications to keep SBP <140 mm Hg. One hundred and forty-one were assigned to the intensive treatment receiving pharmacological SBP reduction to <120 mm Hg upon enrollment. The primary composite outcome was myocardial infarction, and other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. Throughout the 3.06 years of follow-up, a primary outcome event was confirmed in three participants (0.74% per year) in the intensive-treatment group and 8 (1.61% per year) in the standard-treatment group (hazard ratio [HR], 0.19; P = .045). Rates of serious adverse events were not increased by intensive-treatment (HR, 0.83; P = .506). Based on this secondary post hoc analysis, intensive SBP reduction may probably be beneficial for primary prevention of cardiovascular morbidity and mortality in high-risk prehypertensive patients. This finding needs to be evaluated in a larger trial designed specifically to answer this question.",2020,"Rates of serious adverse events were not increased by intensive-treatment (HR, 0.83; P = .506).","['9361 patients enrolled in SPRINT, 289 high-risk (ASCVD risk\xa0=\xa024.8%\xa0±\xa013.0 [10-65]) prehypertensive patients without previous cardiovascular disease and not receiving any antihypertensive medications were enrolled', 'One hundred and forty-one were assigned to the', 'high-risk prehypertensive patients', 'high-risk patients for primary prevention of cardiovascular events', 'prehypertensive patients', 'One hundred and forty-eight of them were assigned to', 'patients with a high-normal blood pressure (prehypertension']","['intensive treatment receiving pharmacological SBP reduction to <120\xa0mm\xa0Hg upon enrollment', 'standard treatment which consisted of clinical follow-up till SBP goes above 140\xa0mm\xa0Hg and then staring medications to keep SBP <140\xa0mm\xa0Hg', 'Pharmacological treatment of high-normal blood pressure (prehypertension']","['cardiovascular morbidity and mortality', 'myocardial infarction, and other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes', 'cardiac morbidity and mortality', 'systolic blood pressure (SBP', 'Rates of serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4517572', 'cui_str': '141'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}]","[{'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",9361.0,0.130189,"Rates of serious adverse events were not increased by intensive-treatment (HR, 0.83; P = .506).","[{'ForeName': 'Roham', 'Initials': 'R', 'LastName': 'Borazjani', 'Affiliation': ""Students' Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.""}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Kojuri', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Abdi-Ardekani', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Peyman', 'Initials': 'P', 'LastName': 'Izadpanah', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Pooyan', 'Initials': 'P', 'LastName': 'Dehghani', 'Affiliation': 'Department of Cardiovascular Medicine, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mehrab', 'Initials': 'M', 'LastName': 'Sayadi', 'Affiliation': ""Students' Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.""}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Attar', 'Affiliation': 'Department of Cardiovascular Medicine, TAHA Clinical Trial Group, Shiraz University of Medical Sciences, Shiraz, Iran.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13994']
2675,32815759,Long-term durability of immunogenicity induced by standard and triple-dose hepatitis B vaccine in patients receiving methadone maintenance treatment.,"OBJECTIVES


We explored the long-term immunogenicity induced by 60 μg and 20 μg hepatitis B vaccines among patients receiving methadone maintenance treatment (MMT).
METHODS


In initial study, a randomized controlled trial was conducted, in which patients receiving MMT were administered 20 µg (IM20 group) or 60 µg (IM60 group) hepatitis B vaccines at months 0, 1, and 6. In this study, the responders at month 7 were followed-up at months 18, 30, and 42 to estimate long-term immunogenicity.
RESULTS


The response rate decreased from 78.0% (39/50) to 31.1% (14/45) in the IM20 group, and from 86.0% (43/50) to 50.0% (20/40) in the IM60 group from month 7 to 42. Vaccine-induced responses in 75% of patients were observed for 14.2 months in the IM20 group and for 20.0 months in the IM60 group, and differences between these two groups were non-significant ( P >0.05).
CONCLUSION


The three-dose 20 µg and 60 µg hepatitis B vaccines showed similar rapid hepatitis B surface antibody decreases.",2020,"The response rate decreased from 78.0% (39/50) to 31.1% (14/45) in the IM20 group, and from 86.0% (43/50) to 50.0% (20/40) in the IM60 group from month 7 to 42.","['patients receiving methadone maintenance treatment (MMT', 'patients receiving methadone maintenance treatment']","['MMT were administered 20 µg (IM20 group) or 60 µg (IM60 group) hepatitis B vaccines', 'standard and triple-dose hepatitis B vaccine']","['Vaccine-induced responses', 'response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588202', 'cui_str': 'Drug addiction therapy - methadone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",,0.0397442,"The response rate decreased from 78.0% (39/50) to 31.1% (14/45) in the IM20 group, and from 86.0% (43/50) to 50.0% (20/40) in the IM60 group from month 7 to 42.","[{'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Yao', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China 030001.'}, {'ForeName': 'Yuanting', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China 030001.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Dong', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China 030001.'}, {'ForeName': 'Linying', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China 030001.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': 'Methadone Maintenance Treatment Clinic, Nanning Red Cross Hospital , Nanning, Guangxi, PR China 530000.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China 030001.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China 030001.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Feng', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China 030001.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China 030001.'}, {'ForeName': 'Yawei', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Yale School of Public Health , New Haven 06510, CT, USA.'}, {'ForeName': 'Yongliang', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China 030001.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Chinese Preventive Medicine Association , Beijing 100009, PR China.'}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'School of Public Health, Shanxi Medical University , Taiyuan, Shanxi, PR China 030001.'}]",Expert review of vaccines,['10.1080/14760584.2020.1813577']
2676,32815803,"The effect of preoperative education on opioid consumption in patients undergoing arthroscopic rotator cuff repair: a prospective, randomized clinical trial-2-year follow-up.","BACKGROUND


With the recent opioid epidemic in the United States, measures by both government and medical providers are being taken to decrease the opioid dependence rate. Different methods have been proposed, including patient education and multimodal pain therapies. The purpose of this study was to determine whether preoperative opioid education reduces the risk of opioid dependence at 2 years following arthroscopic rotator cuff repair (ARCR).
METHODS


This study was a 2-year follow-up of the 2018 Neer Award study that demonstrated the use of preoperative opioid education as a means to reduce postoperative opioid consumption after ARCR at 3-month follow-up. This was a prospective, single-center, single-blinded, parallel-group, 2-arm, randomized clinical trial with a 1:1 allocation ratio. To study the effect of preoperative opioid education on opioid dependence at 2 years, we randomized patients into 2 cohorts, a study cohort and a control cohort. Data were obtained with a review of prescription data-monitoring software and a patient telephone interview.
RESULTS


Opioid education (P = .03; odds ratio, 0.37; 95% confidence interval, 0.14-0.90) was found to be an independent factor that is protective against opioid dependence. Study patients had a lower rate of opioid dependence (11.4%, 8 of 50) than control patients (25.7%, 18 of 50) (P = .05). Significantly fewer prescriptions were filled by study patients (mean, 2.9) than by control patients (mean, 6.3) (P = .03). Additionally, fewer pills were consumed by study patients (median, 60; interquartile range [IQR], 30, 132) than by control patients (median, 120; IQR, 30, 340) (P = .10). Finally, fewer morphine milligram equivalents were consumed by study patients (median, 375; IQR, 199, 1496) than by control patients (median, 725; IQR, 150, 2190) (P = .27).
CONCLUSION


Our study found that patients who were preoperatively educated on opioid use were less likely to become opioid dependent at 2-year follow-up. Therefore, we demonstrated that opioid education does impart significant long-term benefits to patients undergoing ARCR.",2020,"Significantly fewer prescriptions were filled by study patients (mean, 2.9) than by control patients (mean, 6.3) (P = .03).","['patients undergoing arthroscopic rotator cuff repair', 'patients undergoing ARCR']","['preoperative education', 'preoperative opioid education', 'arthroscopic rotator cuff repair (ARCR']","['risk of opioid dependence', 'rate of opioid dependence', 'morphine milligram equivalents', 'postoperative opioid consumption']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}]","[{'cui': 'C0204956', 'cui_str': 'Preoperative education'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0524662', 'cui_str': 'Opioid dependence'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439210', 'cui_str': 'mg'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.135955,"Significantly fewer prescriptions were filled by study patients (mean, 2.9) than by control patients (mean, 6.3) (P = .03).","[{'ForeName': 'Quincy', 'Initials': 'Q', 'LastName': 'Cheesman', 'Affiliation': 'Rothman Orthopaedic Institute at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'DeFrance', 'Affiliation': 'Rowan University School of Osteopathic Medicine, Stratford, NJ, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Stenson', 'Affiliation': 'Rowan University School of Osteopathic Medicine, Stratford, NJ, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Weekes', 'Affiliation': 'Rothman Orthopaedic Institute at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Feldman', 'Affiliation': 'Inspira Health Orthopaedics, Vineland, NJ, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Abboud', 'Affiliation': 'Rothman Orthopaedic Institute at Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Austin', 'Affiliation': 'Rothman Orthopaedic Institute at Thomas Jefferson University, Philadelphia, PA, USA. Electronic address: Luke.austin@rothmanortho.com.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.04.036']
2677,32820002,Comparison of strategies for monitoring and treating patients at the early phase of severe traumatic brain injury: the multicentre randomised controlled OXY-TC trial study protocol.,"INTRODUCTION


Intracranial hypertension is considered as an independent risk factor of mortality and neurological disabilities after severe traumatic brain injury (TBI). However, clinical studies have demonstrated that episodes of brain ischaemia/hypoxia are common despite normalisation of intracranial pressure (ICP). This study assesses the impact on neurological outcome of guiding therapeutic strategies based on the monitoring of both brain tissue oxygenation pressure (PbtO 2 ) and ICP during the first 5 days following severe TBI.
METHODS AND ANALYSIS


Multicentre, open-labelled, randomised controlled superiority trial with two parallel groups in 300 patients with severe TBI. Intracerebral monitoring must be in place within the first 16 hours post-trauma. Patients are randomly assigned to the ICP group or to the ICP + PbtO 2  group. The ICP group is managed according to the international guidelines to maintain ICP≤20 mm Hg. The ICP + PbtO 2  group is managed to maintain PbtO 2  ≥20 mm Hg in addition to the conventional optimisation of ICP. The primary outcome measure is the neurological status at 6 months as assessed using the extended Glasgow Outcome Scale. Secondary outcome measures include quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days. Analysis will be performed according to the intention-to-treat principle and full statistical analysis plan developed prior to database freeze.
ETHICS AND DISSEMINATION


This study has been approved by the Institutional Review Board of Sud-Est V (14-CHUG-48) and from the National Agency for Medicines and Health Products Safety (Agence Nationale de Sécurité du Médicament et des produits de santé) (141 435B-31). Results will be presented at scientific meetings and published in peer-reviewed publications.The study was registered with ClinTrials NCT02754063 on 28 April 2016 (pre-results).",2020,"Secondary outcome measures include quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days.","['patients at the early phase of severe traumatic brain injury', '28 April 2016 (pre-results', '300 patients with severe TBI']","['ICP + PbtO 2  group', 'ICP']","['quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days', 'neurological status at 6 months as assessed using the extended Glasgow Outcome Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0378456', 'cui_str': '3,4,4a,10b-tetrahydro-4-propyl-2H,5H-(1)benzopyrano(4,3-b)-1,4-oxazin-9-ol'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0746866', 'cui_str': 'Neurological status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}]",300.0,0.102688,"Secondary outcome measures include quality-of-life assessment, mortality rate, therapeutic intensity and incidence of critical events during the first 5 days.","[{'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Payen', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France jfpayen@univ-grenoble-alpes.fr.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Richard', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Francony', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Audibert', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Lorraine University, Nancy University Hospital, Nancy, France.'}, {'ForeName': 'Emmanuel L', 'Initials': 'EL', 'LastName': 'Barbier', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Univ. Grenoble Alpes, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Institut des Neurosciences, INSERM, U1216, Grenoble, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bruder', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Aix-Marseille University, Assistance Publique - Hôpitaux de Marseille, Marseille, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dahyot-Fizelier', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Poitiers University Hospital and Poitiers Hospital, Pharmacology of antimicrobial agents, INSERM U1070, Poitiers, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Geeraerts', 'Affiliation': 'Department of Anaesthesia and Intensive Care, Toulouse University Hospital and Toulouse 3-Paul Sabatier University, Toulouse, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Gergele', 'Affiliation': 'Department of Intensive care, Ramsay Sante, Hopital Privé de la Loire, Saint-Etienne, France.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Puybasset', 'Affiliation': 'Department of Anaesthesia and Critical Care, Sorbonne University, GRC 29, AP-HP, DMU DREAM, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Vigue', 'Affiliation': 'Department of Anaesthesia and Intensive care, Centre Hospitalier Universitaire de Bicêtre, Assistance Publique - Hopitaux de Paris, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Skaare', 'Affiliation': 'Department of Public Health, Univ. Grenoble Alpes, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Jean Luc', 'Initials': 'JL', 'LastName': 'Bosson', 'Affiliation': 'TIMC IMAG, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bouzat', 'Affiliation': 'Centre Hospitalier Universitaire de Grenoble, Grenoble, France.'}]",BMJ open,['10.1136/bmjopen-2020-040550']
2678,32820003,"Correction: Effect of PIFR-based optimised inhalation therapy in patients recovering from acute exacerbation of chronic obstructive pulmonary disease: protocol of a prospective, multicentre, superiority, randomised controlled trial.",,2020,,['patients recovering from acute exacerbation of chronic obstructive pulmonary disease'],['PIFR-based optimised inhalation therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021459', 'cui_str': 'Inhalation therapy procedure'}]",[],,0.116939,,[],BMJ open,['10.1136/bmjopen-2019-034804corr1']
2679,32820015,Entospletinib in Combination With Induction Chemotherapy in Previously Untreated Acute Myeloid Leukemia: Response and Predictive Significance of  HOXA9  and  MEIS1  expression.,"PURPOSE


Spleen tyrosine kinase (SYK) signaling is a proposed target in acute myeloid leukemia (AML). Sensitivity to SYK inhibition has been linked to  HOXA9  and  MEIS1  overexpression in preclinical studies. This trial evaluated the safety and efficacy of entospletinib, a selective inhibitor of SYK, in combination with chemotherapy in untreated AML.
METHODS


This was an international multicenter phase 1b/2 study: entospletinib dose escalation (standard 3+3 design between 200 mg and 400 mg BID) + 7+3 (cytarabine + daunorubicin) in phase 1b, and entospletinib dose expansion (400 mg BID) + 7+3 in phase 2.
RESULTS


Fifty-three patients (n=12 phase 1b, n=41 phase 2) with previously untreated de novo (n=39) or secondary (n=14) AML enrolled (58% male, median age 60 years). The composite complete response with entospletinib + 7+3 was 70%. Patients with baseline  HOXA9  and  MEIS1  expression higher than the median had improved overall survival compared to patients with below median  HOXA9  and  MEIS1  expression. Common adverse events were cytopenias, febrile neutropenia, and infection. There were no dose-limiting toxicities. Entospletinib-related skin rash and hyperbilirubinemia were also observed.
CONCLUSION


Entosplentib with intensive chemotherapy was well tolerated in AML patients. Improved survival was observed in patients with  HOXA9/MEIS1  overexpression, contrasting published data demonstrating poor survival in such patients. A randomized study will be necessary to determine whether entospletinib was a mediator this observation.",2020,Patients with baseline  HOXA9  and  MEIS1  expression higher than the median had improved overall survival compared to patients with below median  HOXA9  and  MEIS1  expression.,"['Fifty-three patients (n=12 phase 1b, n=41 phase 2) with previously untreated de novo (n=39) or secondary (n=14) AML enrolled (58% male, median age 60 years', 'acute myeloid leukemia (AML']","['entospletinib dose escalation (standard 3+3 design between 200 mg and 400 mg BID) + 7+3 (cytarabine + daunorubicin', 'Induction Chemotherapy', 'Entosplentib with intensive chemotherapy']","['Entospletinib-related skin rash and hyperbilirubinemia', 'febrile neutropenia, and infection', 'no dose-limiting toxicities', 'overall survival', 'Improved survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3179739', 'cui_str': 'lanthanum citrate'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0020433', 'cui_str': 'Hyperbilirubinemia'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",,0.0519043,Patients with baseline  HOXA9  and  MEIS1  expression higher than the median had improved overall survival compared to patients with below median  HOXA9  and  MEIS1  expression.,"[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Walker', 'Affiliation': 'Department of Internal Medicine/ Division of Hematology, Ohio State University Alison.Walker@osumc.edu.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'Division of Hematology, Department of Medicine, The Ohio State University Medical School.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Blachly', 'Affiliation': 'Division of Hematology, Department of Medicine, The Ohio State University.'}, {'ForeName': 'Bhavana', 'Initials': 'B', 'LastName': 'Bhatnagar', 'Affiliation': 'Comprehensive Cancer Center, Ohio State University.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Mims', 'Affiliation': 'Internal Medicine, Ohio State University.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Orwick', 'Affiliation': 'Department of Hematology, Ohio State University.'}, {'ForeName': 'Tara L', 'Initials': 'TL', 'LastName': 'Lin', 'Affiliation': 'Division of Hematologic Malignancies and Cellular Therapeutics, University of Kansas Medical Center.'}, {'ForeName': 'Howland E', 'Initials': 'HE', 'LastName': 'Crosswell', 'Affiliation': 'Director, Adolescent Young Adult Cancer Care, Bon Secours St. Francis Health System.'}, {'ForeName': 'Danjie', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Gilead Sciences.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Minden', 'Affiliation': 'Leukemia Program, Princess Margaret Cancer Centre.'}, {'ForeName': 'Veerendra', 'Initials': 'V', 'LastName': 'Munugalavadla', 'Affiliation': 'Translational Medicine, Acerta Pharma (AZ).'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Long', 'Affiliation': 'The Ohio State University.'}, {'ForeName': 'Jinfeng', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Bioinformatics, Gilead Sciences, Inc.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Gilead Sciences.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Oellerich', 'Affiliation': 'Department of Medicine II, Hematology/Oncology,, Goethe University Frankfurt.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Serve', 'Affiliation': 'Medicine, Hem/Onc, Goethe University Frankfurt.'}, {'ForeName': 'Arati V', 'Initials': 'AV', 'LastName': 'Rao', 'Affiliation': 'Gilead Sciences.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Blum', 'Affiliation': 'Medicine, Ohio State University.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1064']
2680,32820019,"Psychotherapy, placebos, and informed consent.","Several authors have recently argued that psychotherapy, as it is commonly practiced, is deceptive and undermines patients' ability to give informed consent to treatment. This 'deception' claim is based on the findings that some, and possibly most, of the ameliorative effects in psychotherapeutic interventions are mediated by therapeutic common factors shared by successful treatments (eg, expectancy effects and therapist effects), rather than because of theory-specific techniques. These findings have led to claims that psychotherapy is, at least partly, likely a placebo, and that practitioners of psychotherapy have a duty to 'go open' to patients about the role of common factors in therapy (even if this risks negatively affecting the efficacy of treatment); to not 'go open' is supposed to unjustly restrict patients' autonomy. This paper makes two related arguments against the 'go open' claim. (1) While therapies ought to provide patients with sufficient information to make informed treatment decisions, informed consent does not require that practitioners 'go open' about therapeutic common factors in psychotherapy, and (2) clarity about the mechanisms of change in psychotherapy shows us that the common-factors findings are consistent with, rather than undermining of, the truth of many theory-specific forms of psychotherapy; psychotherapy, as it is commonly practiced, is not deceptive and is not a placebo. The call to 'go open' should be resisted and may have serious detrimental effects on patients via the dissemination of a false view about how therapy works.",2020,"These findings have led to claims that psychotherapy is, at least partly, likely a placebo, and that practitioners of psychotherapy have a duty to 'go open' to patients about the role of common factors in therapy (even if this risks negatively affecting the efficacy of treatment); to not 'go open' is supposed to unjustly restrict patients' autonomy.",[],"['placebo', 'Psychotherapy, placebos']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]",[],,0.0342808,"These findings have led to claims that psychotherapy is, at least partly, likely a placebo, and that practitioners of psychotherapy have a duty to 'go open' to patients about the role of common factors in therapy (even if this risks negatively affecting the efficacy of treatment); to not 'go open' is supposed to unjustly restrict patients' autonomy.","[{'ForeName': 'Garson', 'Initials': 'G', 'LastName': 'Leder', 'Affiliation': 'Alden March Bioethics Institute, Albany Medical College, Albany, NY 12208, USA leder.garson@gmail.com.'}]",Journal of medical ethics,['10.1136/medethics-2020-106453']
2681,32820132,Effects of Combined Strength and Power Training on Physical Performance and Interlimb Asymmetries in Adolescent Female Soccer Players.,"PURPOSE


To examine the effects of an 8-week combined strength and power training intervention on physical performance and interlimb asymmetries in adolescent female soccer players.
METHODS


Thirty-seven adolescent female soccer players (age 16.1 [1.1] y) were randomly assigned to a control group (n = 18) or experimental group (n = 19). The experimental group performed combined strength and power training twice a week, which consisted of strength and power exercises that trained the major muscles of the lower body and trunk musculature. Preintervention and postintervention tests included unilateral and bilateral horizontal and countermovement jump tests, a 40-m sprint test (10- and 30-m split times), a 10-m sprint with a 180° change-of-direction (COD) test, and a multiple-COD test (V-cut test). Asymmetries were also analyzed in the unilateral tests.
RESULTS


Significant group-by-time interaction of the improvement between pretest and posttest was observed for speed (effect size [ES]: -1.30 to -1.16) and COD tests (ES: -0.62 to -0.61) but not in jumping (ES: -0.09 to 0.28) and interlimb-asymmetry tests (ES: -0.13 to 0.57).
CONCLUSIONS


The short-term in-season combined strength and power training program induced greater speed and COD performance improvements than soccer training alone in adolescent female soccer players.",2020,The short-term in-season combined strength and power training program induced greater speed and COD performance improvements than soccer training alone in adolescent female soccer players.,"['Adolescent Female Soccer Players', 'adolescent female soccer players', 'Thirty-seven adolescent female soccer players (age 16.1 [1.1]\xa0y']","['COD tests (ES', 'combined strength and power training intervention', 'strength and power training program', 'Combined Strength and Power Training', 'combined strength and power training twice a week, which consisted of strength and power exercises']","['Physical Performance and Interlimb Asymmetries', 'speed (effect size [ES', 'interlimb-asymmetry tests (ES', 'physical performance and interlimb asymmetries', 'speed and COD performance improvements', 'unilateral and bilateral horizontal and countermovement jump tests, a 40-m sprint test (10- and 30-m split times), a 10-m sprint with a 180° change-of-direction (COD) test, and a multiple-COD test']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C4517491', 'cui_str': '1.1'}]","[{'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0007465', 'cui_str': 'Cause of death'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]",37.0,0.0131409,The short-term in-season combined strength and power training program induced greater speed and COD performance improvements than soccer training alone in adolescent female soccer players.,"[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Pardos-Mainer', 'Affiliation': ''}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Casajús', 'Affiliation': ''}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bishop', 'Affiliation': ''}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gonzalo-Skok', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0265']
2682,32820334,Effect of dapagliflozin according to baseline systolic blood pressure in the Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF).,"AIMS


Concern about hypotension often leads to withholding of beneficial therapy in patients with heart failure and reduced ejection fraction (HFrEF). We evaluated the efficacy and safety of dapagliflozin, which lowers systolic blood pressure (SBP),according to baseline SBP in Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure trial (DAPA-HF).
METHODS AND RESULTS


Key inclusion criteria were: New York Heart Association Class II-IV, left ventricular ejection fraction ≤ 40%, elevated N-terminal pro-B-type natriuretic peptide level, and SBP ≥95 mmHg. The primary outcome was a composite of worsening heart failure or cardiovascular death. The efficacy and safety of dapagliflozin were examined using SBP as both a categorical and continuous variable. A total of 1205 patients had a baseline SBP <110 mmHg; 981 ≥ 110 < 120; 1149 ≥ 120 < 130; and 1409 ≥ 130 mmHg. The placebo-corrected reduction in SBP from baseline to 2 weeks with dapagliflozin was -2.54 (-3.33 to -1.76) mmHg (P < 0.001), with a smaller between-treatment difference in patients in the lowest compared to highest SBP category. Patients in the lowest SBP category had a much higher rate (per 100 person-years) of the primary outcome [20.6, 95% confidence interval (95% CI) 17.6-24.2] than those in the highest SBP category (13.8, 11.7-16.4). The benefit and safety of dapagliflozin was consistent across the range of SBP; hazard ratio (95% CI) in each SBP group, lowest to highest: 0.76 (0.60-0.97), 0.76 (0.57-1.02), 0.81 (0.61-1.08), and 0.67 (0.51-0.87), P interaction = 0.78. Study drug discontinuation did not differ between dapagliflozin and placebo across the SBP categories examined.
CONCLUSION


Dapagliflozin had a small effect on SBP in patients with HFrEF and was superior to placebo in improving outcomes, and well tolerated, across the range of SBP included in DAPA-HF.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov NCT03036124.",2020,"Dapagliflozin had a small effect on SBP in patients with HFrEF and was superior to placebo in improving outcomes, and well tolerated, across the range of SBP included in DAPA-HF.
","['Key inclusion criteria were: New York Heart Association Class II-IV, left ventricular ejection fraction ≤ 40%, elevated N-terminal pro-B-type natriuretic peptide level, and SBP ≥95\u2009mmHg', 'patients with heart failure and reduced ejection fraction (HFrEF', '1205 patients had a baseline SBP <110\u2009mmHg; 981\u2009≥\u2009110\u2009<\u2009120; 1149\u2009≥\u2009120\u2009<\u2009130; and 1409\u2009≥\u2009130\u2009mmHg']","['Dapagliflozin', 'dapagliflozin', 'dapagliflozin and placebo', 'placebo']","['composite of worsening heart failure or cardiovascular death', 'SBP', 'baseline systolic blood pressure', 'systolic blood pressure']","[{'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C4319552', 'cui_str': '130'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4274438', 'cui_str': 'Baseline systolic blood pressure'}]",1205.0,0.177517,"Dapagliflozin had a small effect on SBP in patients with HFrEF and was superior to placebo in improving outcomes, and well tolerated, across the range of SBP included in DAPA-HF.
","[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Serenelli', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Klinik für Innere Medizin III, Universität des Saarlandes, Universitätsklinikum des Saarlandes, Homburg/Saar, Germany.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Cordoba, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Department of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics & Medical Informatics, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'AstraZeneca R&D, Gothenburg, Sweden.'}, {'ForeName': 'Inder S', 'Initials': 'IS', 'LastName': 'Anand', 'Affiliation': 'Department of Cardiology, University of Minnesota, Minneaspolis, MN, USA.'}, {'ForeName': 'Chern-En', 'Initials': 'CE', 'LastName': 'Chiang', 'Affiliation': 'General Clinical Research Center and Division of Cardiology, Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Vijay K', 'Initials': 'VK', 'LastName': 'Chopra', 'Affiliation': 'Department of Cardiology, Max Super Speciality Hospital, Saket, New Delhi, India.'}, {'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'Department of Cardiology, University Medical Center and University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Diez', 'Affiliation': 'Division of Cardiology, Institute Cardiovascular de Buenos Aires, Buenos Aires, Argentina.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Dukát', 'Affiliation': 'Department of Internal Medicine, Comenius University in Bratislava, Bratislava, Slovakia.'}, {'ForeName': 'Junbo', 'Initials': 'J', 'LastName': 'Ge', 'Affiliation': 'Department of Cardiology, Shanghai Institute of Cardiovascular Disease and Zhongshan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Howlett', 'Affiliation': 'Cardiac Sciences and Medicine, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Tzvetana', 'Initials': 'T', 'LastName': 'Katova', 'Affiliation': 'Clinic of Cardiology, National Cardiology Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Kitakaze', 'Affiliation': 'Cardiovascular Division of Medicine, National Cerebral and Cardiovascular Center, Osaka, Japan.'}, {'ForeName': 'Charlotta E A', 'Initials': 'CEA', 'LastName': 'Ljungman', 'Affiliation': 'Department of Molecular and Clinical Medicine and Cardiology, Sahlgrenska Academy, Gothenburg, Sweden.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St Michael's Hospital, University of Toronto, ON, Canada.""}, {'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}]",European heart journal,['10.1093/eurheartj/ehaa496']
2683,32815805,"Glenohumeral joint lavage does not affect clinical outcomes in open reduction and internal fixation of displaced intracapsular proximal humeral fractures: a prospective, randomized, double-blinded trial.","BACKGROUND


This prospective, randomized, and double-blinded trial evaluates the effect of intraoperative glenohumeral joint lavage in open reduction and internal fixation of displaced intracapsular proximal humeral fractures.
METHODS


Between January 2016 and April 2018, 86 patients (mean age: 65.2 ± 16.3 years) with a displaced intracapsular proximal humeral fracture were treated by open reduction and internal fixation using locking plates. Patients were randomized to either locked plating followed by intraoperatively performed glenohumeral joint lavage (group L, n = 36) or locked plating without the lavage (group NL, n = 36). Functional outcome assessment included range of shoulder motion, strength, and the Constant score, obtained 6 weeks, 3 months, 6 months, and 12 months postoperatively. A total of 62 shoulders could be reviewed for final investigation (86% follow-up).
RESULTS


One year after open reduction and internal fixation, the mean Constant score was 70 ± 14 (group L, n = 31) compared with 73 ± 14 (group NL, n = 31, P = .272). The mean forward flexion and abduction in group L was 134 ± 33 and 128 ± 33 as compared with 139 ± 32 and 135 ± 32 in group NL, respectively (P = .538, P = .427). The mean external rotation was 40 ± 16 (group L) compared with 44 ± 16 (group NL) (P = .210). The overall complication rate was 9.6% and did not differ significantly between the groups (P = .321). In group L, there were 2 cases of avascular necrosis (6.5%) and 1 case of secondary displacement (3.2%). In group NL, 1 case of avascular necrosis (3.2%) and 1 case of secondary displacement were noted (3.2%, P = .742).
CONCLUSION


The results of this study do not demonstrate a need for glenohumeral joint lavage in open reduction and internal fixation of displaced intracapsular proximal humeral fractures with regard to shoulder function at 1-year follow-up.",2020,The overall complication rate was 9.6% and did not differ significantly between the groups (P = .321).,"['Between January 2016 and April 2018, 86 patients (mean age: 65.2 ± 16.3 years) with a displaced intracapsular proximal humeral fracture', '62 shoulders could be reviewed for final investigation (86% follow-up', 'displaced intracapsular proximal humeral fractures']","['locked plating without the lavage', 'open reduction and internal fixation using locking plates', 'locked plating followed by intraoperatively performed glenohumeral joint lavage', 'Glenohumeral joint lavage', 'intraoperative glenohumeral joint lavage']","['avascular necrosis', 'overall complication rate', 'range of shoulder motion, strength, and the Constant score', 'mean external rotation', 'mean forward flexion and abduction', 'mean Constant score']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0037006', 'cui_str': 'Fracture of shoulder'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0185373', 'cui_str': 'Open reduction of fracture'}, {'cui': 'C0016642', 'cui_str': 'Internal fixation of fracture'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]","[{'cui': 'C0027543', 'cui_str': 'Avascular necrosis of bone'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0439780', 'cui_str': 'Forward'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}]",,0.0651984,The overall complication rate was 9.6% and did not differ significantly between the groups (P = .321).,"[{'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Biermann', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Schirren', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Siebenbürger', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Evi', 'Initials': 'E', 'LastName': 'Fleischhacker', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Helfen', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Böcker', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Ockert', 'Affiliation': 'Department of General, Trauma and Reconstructive Surgery, University Hospital, LMU Munich, Germany. Electronic address: ben.ockert@med.uni-muenchen.de.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.04.026']
2684,32815806,Effectiveness of supervised physiotherapy after arthroscopic rotator cuff reconstruction: a randomized controlled trial.,"BACKGROUND


The benefit of supervised physiotherapy after rotator cuff surgery is unclear. The aim of this randomized controlled trial was to assess the effectiveness of supervised physiotherapy after arthroscopic rotator cuff reconstruction.
METHODS


Eighty patients with full-thickness supraspinatus tendon tears were randomly assigned to either supervised physiotherapy or home exercises only. The primary outcome measure was the Constant score at 12 months after surgery.
RESULTS


A total of 70 patients were available for analyses at 1-year follow-up. There were no statistically significant differences in the primary outcome between the treatment groups.
CONCLUSION


Supervised physiotherapy after arthroscopic rotator cuff reconstruction does not provide additional benefit compared with home exercises alone at 1-year follow-up.",2020,Supervised physiotherapy after arthroscopic rotator cuff reconstruction does not provide additional benefit compared with home exercises alone at 1-year follow-up.,"['Eighty patients with full-thickness supraspinatus tendon tears', '70 patients were available for analyses at 1-year follow-up', 'arthroscopic rotator cuff reconstruction']","['supervised physiotherapy or home exercises only', 'supervised physiotherapy']",['Constant score'],"[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439809', 'cui_str': 'Full thickness'}, {'cui': 'C0224868', 'cui_str': 'Structure of tendon of supraspinatus muscle'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",70.0,0.21242,Supervised physiotherapy after arthroscopic rotator cuff reconstruction does not provide additional benefit compared with home exercises alone at 1-year follow-up.,"[{'ForeName': 'Pekka', 'Initials': 'P', 'LastName': 'Karppi', 'Affiliation': 'Department of Orthopaedics and Traumatology, Turku University Hospital, Turku, Finland; University of Turku, Turku, Finland. Electronic address: pekka.karppi@tyks.fi.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Ryösä', 'Affiliation': 'Department of Orthopaedics and Traumatology, Turku University Hospital, Turku, Finland; University of Turku, Turku, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Kukkonen', 'Affiliation': 'Department of Surgery, Division of Orthopaedic and Trauma Surgery, Satakunta Central Hospital, Pori, Finland; University of Turku, Turku, Finland.'}, {'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Kauko', 'Affiliation': 'Auria Clinical Informatics, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Ville', 'Initials': 'V', 'LastName': 'Äärimaa', 'Affiliation': 'Department of Orthopaedics and Traumatology, Turku University Hospital, Turku, Finland; University of Turku, Turku, Finland.'}]",Journal of shoulder and elbow surgery,['10.1016/j.jse.2020.04.034']
2685,32815851,"Does Pregnenolone Adjunct to Risperidone Ameliorate Irritable Behavior in Adolescents With Autism Spectrum Disorder: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial?","OBJECTIVES


Pregnenolone is a neurosteroid with modulatory effects on γ-aminobutyric acid neurotransmission. Here, we aimed to evaluate the effectiveness and safety of pregnenolone add-on to risperidone in adolescents with autism spectrum disorders (ASD).
METHODS


Sixty-four ASD patients were randomly allocated to receive either pregnenolone (n = 32) or matching placebo (n = 32) in addition to risperidone. The Aberrant Behavior Checklist-Community Edition scale was used to evaluate the behavioral status of patients at baseline, week 5, and the trial end point. The change in score of irritability subscale was the primary outcome. Frequency of adverse effects due to trial medications was compared between the treatment groups.
RESULTS


Fifty-nine patients completed the trial (30 in pregnenolone and 29 in the placebo arm). Baseline characteristics of both treatment groups were similar (P > 0.05). Repeated measures analysis was suggestive of greater exhibited improvement for the pregnenolone group on irritability, stereotypy, and hyperactivity subscales of the Aberrant Behavior Checklist-Community Edition over the trial period (F = 3.84, df = 1.96, P = 0.025; F = 4.29, df = 1.39, P = 0.029; F = 6.55, df = 1.67, P = 0.004, respectively). Nonetheless, the alterations in lethargy and inappropriate speech domains scores were similar for both arms (F = 0.93, df = 1.49, P = 0.375; F = 1.10, df = 1.60, P = 0.325, respectively). There was no significant difference in frequency as well as severity of adverse effects between the 2 groups.
CONCLUSIONS


Pregnenolone adjunct to risperidone could attenuate core features associated with ASD.",2020,"Repeated measures analysis was suggestive of greater exhibited improvement for the pregnenolone group on irritability, stereotypy, and hyperactivity subscales of the Aberrant Behavior Checklist-Community Edition over the trial period (F = 3.84, df = 1.96, P = 0.025; F = 4.29, df = 1.39, P = 0.029; F = 6.55, df = 1.67, P = 0.004, respectively).","['Spectrum Disorder', 'adolescents with autism spectrum disorders (ASD', 'Sixty-four ASD patients', 'Fifty-nine patients completed the trial (30 in pregnenolone and 29 in the placebo arm', 'Adolescents With Autism']","['Placebo', 'pregnenolone', 'matching placebo', 'risperidone', 'Pregnenolone', 'Risperidone']","['score of irritability subscale', 'severity of adverse effects', 'lethargy and inappropriate speech domains scores', 'effectiveness and safety', 'irritability, stereotypy, and hyperactivity subscales of the Aberrant Behavior Checklist-Community Edition', 'Aberrant Behavior Checklist-Community Edition scale']","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033016', 'cui_str': 'Pregnenolone measurement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033016', 'cui_str': 'Pregnenolone measurement'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C1168248', 'cui_str': 'Inappropriate speech'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0038271', 'cui_str': 'Stereotyped routines'}, {'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",64.0,0.524653,"Repeated measures analysis was suggestive of greater exhibited improvement for the pregnenolone group on irritability, stereotypy, and hyperactivity subscales of the Aberrant Behavior Checklist-Community Edition over the trial period (F = 3.84, df = 1.96, P = 0.025; F = 4.29, df = 1.39, P = 0.029; F = 6.55, df = 1.67, P = 0.004, respectively).","[{'ForeName': 'Arghavan', 'Initials': 'A', 'LastName': 'Ayatollahi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sayna', 'Initials': 'S', 'LastName': 'Bagheri', 'Affiliation': ''}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Ashraf-Ganjouei', 'Affiliation': ''}, {'ForeName': 'Kamyar', 'Initials': 'K', 'LastName': 'Moradi', 'Affiliation': ''}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Mohammadi', 'Affiliation': ''}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': ''}]",Clinical neuropharmacology,['10.1097/WNF.0000000000000405']
2686,32815892,Turning Toward Monitoring of Gaze Stability Exercises: The Utility of Wearable Sensors.,"BACKGROUND AND PURPOSE


Few tools are currently available to quantify gaze stability retraining exercises. This project examined the utility of a head-worn inertial measurement unit (IMU) to quantify head movement frequency, velocity, and amplitude during gaze stability exercises.
METHODS


Twenty-eight individuals with multiple sclerosis and complaints of dizziness or a history of falls were randomly assigned to either a strength and aerobic exercise (SAE) or gaze and postural stability (GPS) group. During a 6-week intervention, participants wore a head-mounted IMU 3 times (early, middle, and late). For aim 1, the frequency, mean peak velocity, and mean peak amplitude of head turns during equivalent duration components of group-specific exercises were compared using general linear models. For aim 2, the progression of treatment in the GPS group was examined using general linear regression models for each outcome.
RESULTS


Aim 1 revealed the GPS group demonstrated significantly greater velocity and amplitude head turns during treatment than the SAE group. The frequency of head turns did not significantly differ between the 2 groups. The aim 2 analyses demonstrated that the yaw and pitch frequency of head turns significantly increased during gaze stability exercises over the 6-week intervention. Velocity and amplitude of head turns during yaw and pitch gaze stability exercises did not significantly change.
DISCUSSION AND CONCLUSIONS


A head-worn IMU during rehabilitation distinguished between groups. Furthermore, within the GPS group, the IMU quantified the progression of the frequency of head movements during gaze stability exercises over time.Video Abstract available for more insights from the authors (see the Video, Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A320).",2020,"Velocity and amplitude of head turns during yaw and pitch gaze stability exercises did not significantly change.
",['Twenty-eight individuals with multiple sclerosis and complaints of dizziness or a history of falls'],"['SAE', 'strength and aerobic exercise (SAE) or gaze and postural stability (GPS) group', 'head-worn inertial measurement unit (IMU', 'Gaze Stability Exercises', 'GPS']","['velocity and amplitude head turns', 'gaze stability exercises', 'Velocity and amplitude of head turns during yaw and pitch gaze stability exercises', 'frequency, mean peak velocity, and mean peak amplitude of head turns', 'frequency of head turns']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0560902', 'cui_str': 'Does turn head'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043388', 'cui_str': 'Yaws'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",28.0,0.0218172,"Velocity and amplitude of head turns during yaw and pitch gaze stability exercises did not significantly change.
","[{'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Loyd', 'Affiliation': 'Department of Physical Therapy and Athletic Training, College of Health, University of Utah, Salt Lake City (B.J.L., J.S-S., A.F., P.B., L.D.); Department of Biomedical Engineering, College of Engineering, University of Utah, Salt Lake City (C.T.); and Department of Otolaryngology Head and Neck Surgery and Physical Medicine and Rehabilitation, School of Medicine, Johns Hopkins University, Baltimore, Maryland (M.S.).'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Saviers-Steiger', 'Affiliation': ''}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Fangman', 'Affiliation': ''}, {'ForeName': 'Parker', 'Initials': 'P', 'LastName': 'Ballard', 'Affiliation': ''}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schubert', 'Affiliation': ''}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Dibble', 'Affiliation': ''}]",Journal of neurologic physical therapy : JNPT,['10.1097/NPT.0000000000000329']
2687,32815902,Factors Associated With Poor Linkage to Human Immunodeficiency Virus Care Among Index Clients and Sex Partners Receiving Human Immunodeficiency Virus Assisted Partner Services in Kenya.,"INTRODUCTION


Human immunodeficiency virus (HIV) assisted partner services (aPS) has been recommended as a strategy to increase HIV case finding. We evaluated factors associated with poor linkage to HIV care among newly diagnosed HIV-positive individuals (index clients) and their partners after receiving aPS in Kenya.
METHODS


In a cluster randomized trial conducted between 2013 and 2015, 9 facilities were randomized to immediate aPS (intervention). Linkage to care-defined as HIV clinic registration, and antiretroviral therapy (ART) initiation were self-reported. Antiretroviral therapy was only offered to those with CD4 less than 500 during this period. We estimated linkage to care and ART initiation separately for index clients and their partners using log-binomial generalized estimating equation models with exchangeable correlation structure and robust standard errors.
RESULTS


Overall, 550 index clients and 621 sex partners enrolled, of whom 46% (284 of 621) were HIV-positive. Of the 284, 264 (93%) sex partners returned at 6 weeks: 120 newly diagnosed and 144 whom had known HIV-positive status. Among the 120 newly diagnosed, only 69% (83) linked to care at 6 weeks, whereas among the 18 known HIV-positive sex partners not already in care at baseline, 61% (11) linked. Newly diagnosed HIV-positive sex partners who were younger and single were less likely to link to care (P < 0.05 for all).
CONCLUSION


Only two thirds of newly diagnosed, and known HIV-positive sex partners not in care linked to care after receiving aPS. The HIV aPS programs should optimize HIV care for newly diagnosed HIV-positive sex partners, especially those who are younger and single.",2020,"Newly diagnosed HIV-positive sex partners who were younger and single were less likely to link to care (P < 0.05 for all).
","['Of the 284, 264 (93%) sex partners returned at 6 weeks: 120 newly diagnosed and 144 whom had known HIV-positive status', '2013 and 2015, 9 facilities', 'Index Clients and Sex Partners', 'newly diagnosed HIV-positive individuals (index clients) and their partners after receiving aPS in Kenya', '120 newly diagnosed, only 69% (83) linked to care at 6 weeks, whereas among the 18 known HIV-positive sex partners not already in care at baseline, 61% (11) linked', '550 index clients and 621 sex partners enrolled, of whom 46% (284 of 621) were HIV-positive', 'Human Immunodeficiency Virus Care', 'Receiving Human Immunodeficiency Virus Assisted Partner Services in Kenya']","['immediate aPS (intervention', 'HIV aPS', 'Human immunodeficiency virus (HIV) assisted partner services (aPS', 'Antiretroviral therapy']",[],"[{'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0580931', 'cui_str': 'In care'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]",[],621.0,0.0547693,"Newly diagnosed HIV-positive sex partners who were younger and single were less likely to link to care (P < 0.05 for all).
","[{'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Wamuti', 'Affiliation': 'From the Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Marielle G', 'Initials': 'MG', 'LastName': 'Contesse', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Maingi', 'Affiliation': 'Voluntary Counseling and Testing (VCT) and HIV Prevention Unit, Kenyatta National Hospital.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Macharia', 'Affiliation': 'Kenya Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Abuna', 'Affiliation': 'From the Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Sambai', 'Affiliation': 'From the Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Ngʼangʼa', 'Affiliation': 'Kenya Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Spiegel', 'Affiliation': 'Kelly Government Solutions, Contractor to Division of AIDS, PMPRB/Prevention Sciences Program, Division of AIDS, NIAID, NIH, Rockville, MD.'}, {'ForeName': 'Barbra', 'Initials': 'B', 'LastName': 'Richardson', 'Affiliation': 'Departments of Biostatistics.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cherutich', 'Affiliation': 'Kenya Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Bukusi', 'Affiliation': 'Voluntary Counseling and Testing (VCT) and HIV Prevention Unit, Kenyatta National Hospital.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Farquhar', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001222']
2688,32815921,Effects of dapagliflozin on blood pressure variability in patients with prediabetes and prehypertension without pharmacological treatment: a randomized trial.,"AIM


The aim of the study was to evaluate the effect of dapagliflozin on blood pressure variability (BPV) in patients with prediabetes and prehypertension without pharmacological treatment.
METHODS


A double-blind, randomized, placebo-controlled clinical study was performed in 30 patients (30-60 years) diagnosed with prediabetes and prehypertension. Study subjects were divided into two groups: a 10-mg dose of dapagliflozin was administered daily before breakfast for 12 weeks in 15 patients or placebo in the remaining 15 patients. At the beginning and end of the study, clinical and metabolic evaluations were performed, and the 24-h BPV was calculated.
RESULTS


Dapagliflozin significantly decreased body weight (P = 0.010), BMI (P = 0.011), fasting plasma glucose (P = 0.002), glycated hemoglobin A1c (P = 0.004), office systolic blood pressure (SBP) (P = 0.001), office diastolic blood pressure (DBP) (P = 0.011), 24-h SBP (121 ± 8 vs. 117 ± 11 mmHg, P = 0.046), nighttime SBP (114 ± 11 vs. 108 ± 10 mmHg, P = 0.017), nocturnal mean arterial pressure (P = 0.043), and nocturnal hypertensive load (P = 0.015); and it significantly increased the percentage of the dipper circadian BP pattern (16.7 vs. 30.8%, P = 0.047). After the administration of dapagliflozin, some of the patients did not meet the diagnostic criteria for prediabetes (26.9%) or prehypertension (26.9%).
CONCLUSIONS


The administration of 10 mg dapagliflozin once daily for 90 days in patients with prediabetes and prehypertension decreased BPV by reducing 24-h and nighttime SBP, and increasing the dipper circadian BP pattern.",2020,"RESULTS


Dapagliflozin significantly decreased body weight (P = 0.010), BMI (P = 0.011), fasting plasma glucose (P = 0.002), glycated hemoglobin A1c (P = 0.004), office systolic blood pressure (SBP) (P = 0.001), office diastolic blood pressure (DBP) (P = 0.011), 24-h SBP (121 ± 8 vs. 117 ± 11 mmHg, P = 0.046), nighttime SBP (114 ± 11 vs. 108 ± 10 mmHg, P = 0.017), nocturnal mean arterial pressure (P = 0.043), and nocturnal hypertensive load (P = 0.015); and","['30 patients (30-60\u2009years) diagnosed with prediabetes and prehypertension', 'patients with prediabetes and prehypertension without pharmacological treatment']","['dapagliflozin', 'placebo']","['24-h SBP', 'nocturnal hypertensive load', 'body weight', 'glycated hemoglobin A1c', 'office systolic blood pressure (SBP', 'nocturnal mean arterial pressure', 'dipper circadian BP pattern', 'BMI', 'blood pressure variability', 'office diastolic blood pressure (DBP', 'percentage of the dipper circadian BP pattern', 'blood pressure variability (BPV', 'fasting plasma glucose', 'nighttime SBP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0326560', 'cui_str': 'Cinclidae'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",30.0,0.0519784,"RESULTS


Dapagliflozin significantly decreased body weight (P = 0.010), BMI (P = 0.011), fasting plasma glucose (P = 0.002), glycated hemoglobin A1c (P = 0.004), office systolic blood pressure (SBP) (P = 0.001), office diastolic blood pressure (DBP) (P = 0.011), 24-h SBP (121 ± 8 vs. 117 ± 11 mmHg, P = 0.046), nighttime SBP (114 ± 11 vs. 108 ± 10 mmHg, P = 0.017), nocturnal mean arterial pressure (P = 0.043), and nocturnal hypertensive load (P = 0.015); and","[{'ForeName': 'Cristal', 'Initials': 'C', 'LastName': 'Díaz-Cruz', 'Affiliation': 'Departamento de Fisiología, Instituto de Terapéutica Experimental y Clínica, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Jalisco, México.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'González-Ortiz', 'Affiliation': ''}, {'ForeName': 'Lizet Y', 'Initials': 'LY', 'LastName': 'Rosales-Rivera', 'Affiliation': ''}, {'ForeName': 'Anayeli de J', 'Initials': 'AJ', 'LastName': 'Patiño-Laguna', 'Affiliation': ''}, {'ForeName': 'Zaire G', 'Initials': 'ZG', 'LastName': 'Ramírez-Rodríguez', 'Affiliation': ''}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Díaz-Cruz', 'Affiliation': ''}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Martínez-Abundis', 'Affiliation': ''}]",Blood pressure monitoring,['10.1097/MBP.0000000000000479']
2689,32815922,Ambulatory blood pressure variability and combined exercise training: comparison between hypertensive and normotensive postmenopausal women.,"AIM


The aim of the study was to verify the effects of moderate combined aerobic and resistance exercises training in ambulatory blood pressure (ABPM) and its variability in hypertensive and normotensive postmenopausal women.
METHODS


Twenty-six participants were divided into two groups: hypertensive (HT = 13) and normotensive (NT = 13). They performed 30 sessions of combined exercises (aerobic and resistance exercises at same session) over 10 weeks. We evaluated: resting BP and 24-h ABPM with systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), and heart rate (HR). To evaluate blood pressure variability (BPV), the following were considered: 24-h SD (SD24), the mean diurnal and nocturnal deviations (SDdn), average real variability (ARV24).
RESULTS


The two-way analysis of variance showed no difference in ABPM nor BPV responses after training between groups. Both HT and NT groups had similar BP reductions in 24-h DBP (P < 0.01; ΔNT = -3.1 ± 1.1, ΔHT = -1.8 ± 1.2 mmHg), 24-h area under the curve of DBP (P = 0.01; ΔNT = -73±105, ΔHT = -44 ± 115 mmHg), and wake DBP (P < 0.01; ΔNT = -3.4 ± 1.2, ΔHT = -1.8 ± 1.3 mmHg), without differences in BPV responses. Moreover, HT women had higher overall SBP SDdn (P = 0.01), SBP ARV (P = 0.02), and MBP ARV (P < 0.01) than NT women.
CONCLUSION


Ten-week combined exercise training resulted in similar BP reductions in hypertensive and normotensive postmenopausal women, but not in BPV responses.",2020,"Both HT and NT groups had similar BP reductions in 24-h DBP (P < 0.01; ΔNT = -3.1 ± 1.1, ΔHT = -1.8 ± 1.2 mmHg), 24-h area under the curve of DBP (P = 0.01; ΔNT = -73±105, ΔHT = -44 ± 115 mmHg), and wake DBP (P < 0.01; ΔNT = -3.4 ± 1.2, ΔHT = -1.8 ± 1.3 mmHg), without differences in BPV responses.","['Twenty-six participants were divided into two groups: hypertensive (HT\u2009=\u200913) and normotensive (NT\u2009=\u200913', 'hypertensive and normotensive postmenopausal women']","['combined exercises (aerobic and resistance exercises', 'exercise training', 'combined exercise training', 'moderate combined aerobic and resistance exercises training']","['24-h SD (SD24), the mean diurnal and nocturnal deviations (SDdn), average real variability (ARV24', 'BPV responses', 'BP reductions', 'SBP ARV', 'ambulatory blood pressure (ABPM', 'resting BP and 24-h ABPM with systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), and heart rate (HR', 'Ambulatory blood pressure variability', 'ABPM nor BPV responses', 'BP reductions in 24-h DBP', '24-h area under the curve of DBP', 'MBP ARV', 'blood pressure variability (BPV', 'overall SBP SDdn', 'wake DBP']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0442696', 'cui_str': 'Waking'}]",26.0,0.0178929,"Both HT and NT groups had similar BP reductions in 24-h DBP (P < 0.01; ΔNT = -3.1 ± 1.1, ΔHT = -1.8 ± 1.2 mmHg), 24-h area under the curve of DBP (P = 0.01; ΔNT = -73±105, ΔHT = -44 ± 115 mmHg), and wake DBP (P < 0.01; ΔNT = -3.4 ± 1.2, ΔHT = -1.8 ± 1.3 mmHg), without differences in BPV responses.","[{'ForeName': 'Igor Moraes', 'Initials': 'IM', 'LastName': 'Mariano', 'Affiliation': 'Physical Education Department, Federal University of Uberlandia, Aparecida, Uberlândia, Brazil.'}, {'ForeName': 'Juliene Gonçalves Costa', 'Initials': 'JGC', 'LastName': 'Dechichi', 'Affiliation': ''}, {'ForeName': 'Larissa Aparecida Santos', 'Initials': 'LAS', 'LastName': 'Matias', 'Affiliation': ''}, {'ForeName': 'Mateus de Lima', 'Initials': 'ML', 'LastName': 'Rodrigues', 'Affiliation': ''}, {'ForeName': 'Jaquueline Pontes', 'Initials': 'JP', 'LastName': 'Batista', 'Affiliation': ''}, {'ForeName': 'Tállita Cristina Ferreira', 'Initials': 'TCF', 'LastName': 'de Souza', 'Affiliation': ''}, {'ForeName': 'Ana Luiza', 'Initials': 'AL', 'LastName': 'Amaral', 'Affiliation': ''}, {'ForeName': 'Victor Hugo Vilarinho', 'Initials': 'VHV', 'LastName': 'Carrijo', 'Affiliation': ''}, {'ForeName': 'Guilherme Morais', 'Initials': 'GM', 'LastName': 'Puga', 'Affiliation': ''}]",Blood pressure monitoring,['10.1097/MBP.0000000000000480']
2690,32816096,Effects of an intensive lifestyle intervention on the underlying mechanisms of improved glycaemic control in individuals with type 2 diabetes: a secondary analysis of a randomised clinical trial.,"AIMS/HYPOTHESIS


The aim was to investigate whether an intensive lifestyle intervention, with high volumes of exercise, improves beta cell function and to explore the role of low-grade inflammation and body weight.
METHODS


This was a randomised, assessor-blinded, controlled trial. Ninety-eight individuals with type 2 diabetes (duration <10 years), BMI of 25-40 kg/m 2 , no use of insulin and taking fewer than three glucose-lowering medications were randomised (2:1) to either the standard care plus intensive lifestyle group or the standard care alone group. Standard care consisted of individual guidance on disease management, lifestyle advice and blinded regulation of medication following a pre-specified algorithm. The intensive lifestyle intervention consisted of aerobic exercise sessions that took place 5-6 times per week, combined with resistance exercise sessions 2-3 times per week, with a concomitant dietary intervention aiming for a BMI of 25 kg/m 2 . In this secondary analysis beta cell function was assessed from the 2 h OGTT-derived disposition index, which is defined as the product of the Matsuda and the insulinogenic indices.
RESULTS


At baseline, individuals were 54.8 years (SD 8.9), 47% women, type 2 diabetes duration 5 years (IQR 3-8) and HbA 1c  was 49.3 mmol/mol (SD 9.2); 6.7% (SD 0.8). The intensive lifestyle group showed 40% greater improvement in the disposition index compared with the standard care group (ratio of geometric mean change [RGM] 1.40 [95% CI 1.01, 1.94]) from baseline to 12 months' follow-up. Plasma concentration of IL-1 receptor antagonist (IL-1ra) decreased 30% more in the intensive lifestyle group compared with the standard care group (RGM 0.70 [95% CI 0.58, 0.85]). Statistical single mediation analysis estimated that the intervention effect on the change in IL-1ra and the change in body weight explained to a similar extent (59%) the variance in the intervention effect on the disposition index.
CONCLUSIONS/INTERPRETATION


Our findings show that incorporating an intensive lifestyle intervention, with high volumes of exercise, in individuals with type 2 diabetes has the potential to improve beta cell function, associated with a decrease in low-grade inflammation and/or body weight.
TRIAL REGISTRATION


ClinicalTrials.gov NCT02417012 Graphical abstract.",2020,Plasma concentration of IL-1 receptor antagonist (IL-1ra) decreased 30% more in the intensive lifestyle group compared with the standard care group (RGM 0.70,"['Ninety-eight individuals with type 2 diabetes (duration <10\xa0years), BMI of 25-40\xa0kg/m 2 , no use of insulin and taking fewer than three glucose-lowering medications', 'individuals with type 2 diabetes']","['aerobic exercise sessions', 'standard care plus intensive lifestyle group or the standard care alone group', 'intensive lifestyle intervention']","['Plasma concentration of IL-1 receptor antagonist (IL-1ra', 'disposition index', 'beta cell function', 'body weight']","[{'cui': 'C4319627', 'cui_str': '98'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0063710', 'cui_str': 'Interleukin 1 Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0245109', 'cui_str': 'anakinra'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",98.0,0.0980522,Plasma concentration of IL-1 receptor antagonist (IL-1ra) decreased 30% more in the intensive lifestyle group compared with the standard care group (RGM 0.70,"[{'ForeName': 'Mette Y', 'Initials': 'MY', 'LastName': 'Johansen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen, Denmark. mette.yun.johansen@regionh.dk.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Christopher S', 'Initials': 'CS', 'LastName': 'MacDonald', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Katrine B', 'Initials': 'KB', 'LastName': 'Hansen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Bolette', 'Initials': 'B', 'LastName': 'Hartmann', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicolai J', 'Initials': 'NJ', 'LastName': 'Wewer Albrechtsen', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Allan A', 'Initials': 'AA', 'LastName': 'Vaag', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bente K', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ried-Larsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}]",Diabetologia,['10.1007/s00125-020-05249-7']
2691,32816144,Effects of a cooling vest with sham condition on walking capacity in heat-sensitive people with Multiple Sclerosis.,"PURPOSE


Heat sensitivity is a common contraindication in people with Multiple Sclerosis (pwMS), and physical fatigue is one of the most frequently reported symptoms that can affect quality of life. Increases in body temperature may exacerbate fatigue and heat-related symptoms. Decreasing body temperature via cooling devices may mitigate disease symptoms and improve physical abilities and quality of life. This study evaluates the effects of a cooling vest with sham condition on walking capacity using a commercially-available cooling vest specifically designed for pwMS.
METHODS


A counter-balanced, cross-over design was used to assess the effects of a cooling vest (CryoVest Comfort, CryoInnov, France) (COLD) from a menthol-induced sham condition (CON) on ground walking time to exhaustion (T ex , s) and distance at exhaustion (D ex , m) in ambulatory pwMS. Secondary outcomes were heart rate (HR, bpm), thermal sensation (Tsens), skin chest (Tchest) and back (Tback) temperature.
RESULTS


Ten females with Multiple Sclerosis (59 ± 9 years, EDSS 3.0-5.5) participated to the study. During COLD, pwMS walked significantly longer (1896 ± 602 vs. 1399 ± 404 s, p < 0.001) and farther (1879 ± 539 vs. 1302 ± 318 m, p < 0.001) than CON. Importantly, Tsens and HR at exhaustion were not significantly different between conditions, although Tchest (- 2.7 ± 1.8 °C, p < 0.01) and Tback (- 3.9 ± 1.8 °C, p < 0.001) were lower at volitional fatigue during COLD.
CONCLUSION


The lightweight cooling vest improved total walking time and distance in heat-sensitive pwMS. These physiological improvements were likely due to feeling perceptually cooler in the COLD trial, compared to the corresponding point of fatigue in the CON condition.",2020,"During COLD, pwMS walked significantly longer (1896 ± 602 vs. 1399 ± 404 s, p < 0.001) and farther (1879 ± 539 vs. 1302 ± 318 m, p < 0.001) than CON.","['people with Multiple Sclerosis (pwMS', 'Ten females with Multiple Sclerosis (59\u2009±\u20099\xa0years, EDSS 3.0-5.5) participated to the study', 'heat-sensitive people with Multiple Sclerosis']","['cooling vest (CryoVest Comfort, CryoInnov, France) (COLD) from a menthol-induced sham condition (CON', 'cooling vest with sham condition', 'lightweight cooling vest']","['total walking time and distance', 'walking capacity', 'Tsens and HR at exhaustion', 'ground walking time to exhaustion (T ex , s) and distance at exhaustion (D ex , m) in ambulatory pwMS', 'heart rate (HR, bpm), thermal sensation (Tsens), skin chest (Tchest) and back (Tback) temperature', 'physical abilities and quality of life']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231274', 'cui_str': 'Intolerant of heat'}]","[{'cui': 'C0453884', 'cui_str': 'Vest'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0039478', 'cui_str': 'Thermal sensation, function'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0439385', 'cui_str': 'beats/min'}, {'cui': 'C0222149', 'cui_str': 'Skin structure of chest'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",10.0,0.0289915,"During COLD, pwMS walked significantly longer (1896 ± 602 vs. 1399 ± 404 s, p < 0.001) and farther (1879 ± 539 vs. 1302 ± 318 m, p < 0.001) than CON.","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Buoite Stella', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy. abuoitestella@units.it.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Pasquin', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy.'}, {'ForeName': 'Shawnda A', 'Initials': 'SA', 'LastName': 'Morrison', 'Affiliation': 'Faculty of Sport, University of Ljubljana, Gortanova 22, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Maria Elisa', 'Initials': 'ME', 'LastName': 'Morelli', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Dinoto', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy.'}, {'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Bratina', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Bosco', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Sartori', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Giudici', 'Affiliation': 'Statistics Unit, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manganotti', 'Affiliation': 'Clinical Unit of Neurology, Department of Medicine, Surgery and Health Sciences, Cattinara University Hospital ASUGI, University of Trieste, Strada Di Fiume, 447, 34149, Trieste, Italy.'}]",European journal of applied physiology,['10.1007/s00421-020-04478-3']
2692,32816177,Physiological effects of two driving pressure-based methods to set positive end-expiratory pressure during one lung ventilation.,"During one-lung ventilation (OLV), titrating the positive end-expiratory pressure (PEEP) to target a low driving pressure (∆P) could reduce postoperative pulmonary complications. However, it is unclear how to conduct PEEP titration: by stepwise increase starting from zero PEEP (PEEP INCREMENTAL ) or by stepwise decrease after a lung recruiting manoeuvre (PEEP DECREMENTAL ). In this randomized trial, we compared the physiological effects of these two PEEP titration strategies on respiratory mechanics, ventilation/perfusion mismatch and gas exchange. Patients undergoing video-assisted thoracoscopic surgery in OLV were randomly assigned to a PEEP INCREMENTAL  or PEEP DECREMENTAL  strategy to match the lowest ∆P. In the PEEP INCREMENTAL  group, PEEP was stepwise titrated from ZEEP up to 16 cm H 2 O, whereas in the PEEP DECREMENTAL  group PEEP was decrementally titrated, starting from 16 cm H 2 O, immediately after a lung recruiting manoeuvre. Respiratory mechanics, ventilation/perfusion mismatch and blood gas analyses were recorded at baseline, after PEEP titration and at the end of surgery. Sixty patients were included in the study. After PEEP titration, shunt decreased similarly in both groups, from 50 [39-55]% to 35 [28-42]% in the PEEP INCREMENTAL  and from 45 [37-58]% to 33 [25-45]% in the PEEP DECREMENTAL  group (both p < 0.001 vs baseline). The resulting ∆P, however, was lower in the PEEP DECREMENTAL  than in the PEEP INCREMENTAL  group (8 [7-11] vs 10 [9-11] cm H 2 O; p = 0.03). In the PEEP DECREMENTAL  group the PaO 2 / FIO 2  ratio increased significantly after intervention (from 140 [99-176] to 186 [152-243], p < 0.001). Both the PEEP INCREMENTAL  and the PEEP DECREMENTAL  strategies were able to decrease intraoperative shunt, but only PEEP DECREMENTAL  improved oxygenation and lowered intraoperative ΔP.Clinical trial number NCT03635281; August 2018; ""retrospectively registered"".",2020,"Both the PEEP INCREMENTAL  and the PEEP DECREMENTAL  strategies were able to decrease intraoperative shunt, but only PEEP DECREMENTAL  improved oxygenation and lowered intraoperative ΔP.Clinical trial number NCT03635281; August 2018; ""retrospectively registered"".","['Patients undergoing video-assisted thoracoscopic surgery in OLV', 'Sixty patients were included in the study']","['two driving pressure-based methods to set positive end-expiratory pressure during one lung ventilation', 'PEEP INCREMENTAL  or PEEP DECREMENTAL  strategy to match the lowest ∆P', 'lung ventilation (OLV), titrating the positive end-expiratory pressure (PEEP) to target a low driving pressure (∆P']","['respiratory mechanics, ventilation/perfusion mismatch and gas exchange', 'Respiratory mechanics, ventilation/perfusion mismatch and blood gas analyses', 'postoperative pulmonary complications', 'PaO 2 / FIO 2  ratio']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C0559312', 'cui_str': 'One lung ventilation'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0554804', 'cui_str': 'Assisted breathing'}]","[{'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",60.0,0.173319,"Both the PEEP INCREMENTAL  and the PEEP DECREMENTAL  strategies were able to decrease intraoperative shunt, but only PEEP DECREMENTAL  improved oxygenation and lowered intraoperative ΔP.Clinical trial number NCT03635281; August 2018; ""retrospectively registered"".","[{'ForeName': 'Savino', 'Initials': 'S', 'LastName': 'Spadaro', 'Affiliation': ""Department of Morphology, Experimental Medicine and Surgery, Section of Anaesthesia and Intensive Care, Azienda Ospedaliera-Universitaria Sant' Anna, University of Ferrara, Via Aldo Moro, 8, 44124, Ferrara, Italy. savinospadaro@gmail.com.""}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Grasso', 'Affiliation': 'Department of Emergency and Organ Transplant (DETO), ""Aldo Moro"" University of Bari, Bari, Italy.'}, {'ForeName': 'Dan Stieper', 'Initials': 'DS', 'LastName': 'Karbing', 'Affiliation': 'Respiratory and Critical Care Group, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Santoro', 'Affiliation': ""Department of Morphology, Experimental Medicine and Surgery, Section of Anaesthesia and Intensive Care, Azienda Ospedaliera-Universitaria Sant' Anna, University of Ferrara, Via Aldo Moro, 8, 44124, Ferrara, Italy.""}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Cavallesco', 'Affiliation': ""Department of Morphology, Experimental Medicine and Surgery, Thoracic Surgery, Azienda Ospedaliera-Universitaria Sant' Anna, University of Ferrara, Ferrara, Italy.""}, {'ForeName': 'Pio', 'Initials': 'P', 'LastName': 'Maniscalco', 'Affiliation': ""Department of Morphology, Experimental Medicine and Surgery, Thoracic Surgery, Azienda Ospedaliera-Universitaria Sant' Anna, University of Ferrara, Ferrara, Italy.""}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Murgolo', 'Affiliation': 'Department of Emergency and Organ Transplant (DETO), ""Aldo Moro"" University of Bari, Bari, Italy.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Di Mussi', 'Affiliation': 'Department of Emergency and Organ Transplant (DETO), ""Aldo Moro"" University of Bari, Bari, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Ragazzi', 'Affiliation': ""Department of Morphology, Experimental Medicine and Surgery, Section of Anaesthesia and Intensive Care, Azienda Ospedaliera-Universitaria Sant' Anna, University of Ferrara, Via Aldo Moro, 8, 44124, Ferrara, Italy.""}, {'ForeName': 'Stephen Edward', 'Initials': 'SE', 'LastName': 'Rees', 'Affiliation': 'Respiratory and Critical Care Group, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Carlo Alberto', 'Initials': 'CA', 'LastName': 'Volta', 'Affiliation': ""Department of Morphology, Experimental Medicine and Surgery, Section of Anaesthesia and Intensive Care, Azienda Ospedaliera-Universitaria Sant' Anna, University of Ferrara, Via Aldo Moro, 8, 44124, Ferrara, Italy.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Fogagnolo', 'Affiliation': ""Department of Morphology, Experimental Medicine and Surgery, Section of Anaesthesia and Intensive Care, Azienda Ospedaliera-Universitaria Sant' Anna, University of Ferrara, Via Aldo Moro, 8, 44124, Ferrara, Italy.""}]",Journal of clinical monitoring and computing,['10.1007/s10877-020-00582-z']
2693,32816189,Exercise training affects hemodynamics not cardiac function during anthracycline-based chemotherapy.,"INTRODUCTION


Preclinical data demonstrate the potential for exercise training to protect against anthracycline-related cardiotoxicity, but this remains to be shown in humans.
PURPOSE


To assess whether exercise training during anthracycline-based chemotherapy for treatment of breast cancer affects resting cardiac function and hemodynamics.
METHODS


In this prospective, non-randomized controlled study, 26 women who participated in aerobic and resistance training 3×/wk during chemotherapy were compared to 11 women receiving usual care. Two-dimensional echocardiography was performed before and 7-14 days after completion of anthracycline-based chemotherapy. Pre- and post-anthracycline cardiac function and hemodynamic variables were compared within each group with paired t-tests; the change was compared between groups using ANCOVA with adjustment for baseline values.
RESULTS


Left ventricular longitudinal strain, volumes, ejection fraction, E/A ratio, and mass did not change in either group. Hemoglobin, hematocrit, and mean arterial pressure decreased significantly from baseline in both groups (all p < 0.05) with no differences between groups. Cardiac output increased in the usual care group only (+ 0.27 ± 0.24 L/min/m 2 , p < 0.01), which differed significantly from the exercise group (p = 0.03). Systemic vascular resistance (SVR) decreased in both groups (usual care: - 444, p < 0.01; exercise: - 265, dynes/s/cm 5 , p = 0.01). However, the reduction in SVR was significantly attenuated in the exercise group (p = 0.03) perhaps due to a compensatory decrease in estimated vessel lumen radius.
CONCLUSION


Exercise training during anthracycline chemotherapy treatment had no effect on resting cardiac function but appeared to modify hemodynamic responses. Specifically, exercise training attenuated the drop in SVR in response to chemotherapy-related reductions in hematocrit potentially by increasing vessel lumen radius.",2020,"Systemic vascular resistance (SVR) decreased in both groups (usual care: - 444, p < 0.01; exercise: - 265, dynes/s/cm 5 , p = 0.01).","['11 women receiving usual care', '26 women who participated in']","['exercise training', 'aerobic and resistance training 3×/wk during chemotherapy', 'Exercise training', 'anthracycline-based chemotherapy', 'exercise training during anthracycline-based chemotherapy']","['Hemoglobin, hematocrit, and mean arterial pressure', 'Cardiac output', 'reduction in SVR', 'Pre- and post-anthracycline cardiac function and hemodynamic variables', 'resting cardiac function', 'Left ventricular longitudinal strain, volumes, ejection fraction, E/A ratio, and mass', 'Systemic vascular resistance (SVR']","[{'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",26.0,0.0287775,"Systemic vascular resistance (SVR) decreased in both groups (usual care: - 444, p < 0.01; exercise: - 265, dynes/s/cm 5 , p = 0.01).","[{'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Kirkham', 'Affiliation': 'University of Alberta, 1098 Research Transition Facility, 8308 114 Street NW, Edmonton, AB, T6G 2V2, Canada.'}, {'ForeName': 'Sean A', 'Initials': 'SA', 'LastName': 'Virani', 'Affiliation': 'University of British Columbia, 212-2177 Wesbrook Mall, Vancouver, V6T 1Z3, Canada.'}, {'ForeName': 'Kelcey A', 'Initials': 'KA', 'LastName': 'Bland', 'Affiliation': 'Australian Catholic University, 115 Victoria Parade, Fitzroy, VIC, 3065, Australia.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'McKenzie', 'Affiliation': 'University of British Columbia, 212-2177 Wesbrook Mall, Vancouver, V6T 1Z3, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Gelmon', 'Affiliation': 'University of British Columbia, 212-2177 Wesbrook Mall, Vancouver, V6T 1Z3, Canada.'}, {'ForeName': 'Darren E R', 'Initials': 'DER', 'LastName': 'Warburton', 'Affiliation': 'University of British Columbia, 212-2177 Wesbrook Mall, Vancouver, V6T 1Z3, Canada.'}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Campbell', 'Affiliation': 'University of British Columbia, 212-2177 Wesbrook Mall, Vancouver, V6T 1Z3, Canada. Kristin.Campbell@ubc.ca.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05824-x']
2694,32816215,Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials.,"BACKGROUND


Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Creatine kinase (CK) levels and CK-related adverse events (AEs) in tofacitinib-treated patients with UC were evaluated.
METHODS


Data were analyzed for three UC cohorts: Induction (phase 2 and 3 induction studies); Maintenance (phase 3 maintenance study); Overall [patients who received tofacitinib 5 or 10 mg twice daily (b.d.) in phase 2, phase 3, or open-label, long-term extension studies; data at November 2017]. Clinical trial data for tofacitinib-treated patients with rheumatoid arthritis, psoriasis, and psoriatic arthritis are presented for contextualization.
RESULTS


Week 8 mean change from baseline CK with tofacitinib 10 mg b.d. induction therapy was 91.1 U/L (95% CI, 48.1-134.1) versus 19.2 U/L (8.5-29.9) with placebo. Among patients completing induction with 10 mg b.d. and re-randomized to 52 weeks of maintenance therapy, mean increases from induction baseline to the end of maintenance were 35.9 (8.1-63.7), 90.3 (51.9-128.7), and 115.6 U/L (91.6-139.7), with placebo, 5 and 10 mg b.d., respectively. The incidence rate (unique patients with events per 100 patient-years) for AEs of CK elevation in the tofacitinib-treated UC Overall cohort was 6.6 versus 2.2, 6.5, and 3.7 for tofacitinib-treated patients with rheumatoid arthritis, psoriasis, and psoriatic arthritis, respectively. No serious AEs of CK elevation or AEs of myopathy occurred in UC studies.
CONCLUSIONS


In patients with UC, CK elevations with tofacitinib appeared reversible and not associated with clinically significant AEs. UC findings were consistent with tofacitinib use in other inflammatory diseases.
TRIAL REGISTRATION


NCT00787202; NCT01465763; NCT01458951; NCT01458574; NCT01470612; NCT01262118; NCT01484561; NCT00147498; NCT00413660; NCT00550446; NCT00603512; NCT00687193; NCT01059864; NCT01164579; NCT00976599; NCT01359150; NCT02147587; NCT00960440; NCT00847613; NCT00814307; NCT00856544; NCT00853385; NCT01039688; NCT02187055; NCT00413699; NCT00661661; NCT01710046; NCT00678210; NCT01276639; NCT01309737; NCT01241591; NCT01186744; NCT01163253; NCT01877668; NCT01882439; NCT01976364.",2020,"No serious AEs of CK elevation or AEs of myopathy occurred in UC studies.
","['Treated Patients with Ulcerative Colitis', 'Data were analyzed for three UC cohorts: Induction (phase 2 and 3 induction studies); Maintenance (phase 3 maintenance study', 'treated patients with rheumatoid arthritis, psoriasis, and psoriatic arthritis']","['Tofacitinib', 'tofacitinib', 'placebo']","['CK elevations', 'incidence rate', 'Creatine kinase (CK) levels and CK-related adverse events (AEs', 'CK elevation', 'CK elevation or AEs of myopathy']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic arthritis'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}]",,0.408836,"No serious AEs of CK elevation or AEs of myopathy occurred in UC studies.
","[{'ForeName': 'Remo', 'Initials': 'R', 'LastName': 'Panaccione', 'Affiliation': 'Department of Medicine, University of Calgary, 3330 Hospital Drive NW, Calgary, AB, T2N 4N1, Canada. rpanacci@ucalgary.ca.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Isaacs', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University and Musculoskeletal Unit, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lea Ann', 'Initials': 'LA', 'LastName': 'Chen', 'Affiliation': 'New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Inflammation and Immunology, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Marren', 'Affiliation': 'Inflammation and Immunology, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kwok', 'Affiliation': 'Inflammation and Immunology, Pfizer Inc, New York, NY, USA.'}, {'ForeName': 'Lisy', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Inflammation and Immunology, Pfizer Inc, Groton, CT, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Chan', 'Affiliation': 'Inflammation and Immunology, Pfizer Inc, Collegeville, PA, USA.'}, {'ForeName': 'Chinyu', 'Initials': 'C', 'LastName': 'Su', 'Affiliation': 'Inflammation and Immunology, Pfizer Inc, Collegeville, PA, USA.'}]",Digestive diseases and sciences,['10.1007/s10620-020-06560-4']
2695,30834611,How to implant a phrenic nerve stimulator for treatment of central sleep apnea?,"BACKGROUND


Central sleep apnea (CSA) is a breathing disorder caused by the intermittent absence of central respiratory drive. Transvenous phrenic nerve stimulation is a new therapeutic option, recently approved by the FDA , for the treatment of CSA.
OBJECTIVE


To describe the technique used to implant the transvenous phrenic nerve stimulation system (the remedē System, Respicardia, Inc).
METHODS


The remedē System is placed in the pectoral region, typically on the right side. A single stimulation lead is placed in either the left pericardiophrenic vein (PPV) or the right brachiocephalic vein (RBC). A sensing lead is placed into the azygous vein to detect respiration.
RESULTS


In the remedē System Pivotal trial, 147 of 151 (97%) patients were successfully implanted with the system. Sixty-two percent of stimulation leads were placed in the PPV and 35% in the RBC. Mean procedure time was 2.7 ± 0.8 hours and 94% of patients were free from implant-related serious adverse events through 6 months.
CONCLUSION


In patients with CSA, transvenous phrenic nerve stimulation is an effective and safe therapy with an implant procedure similar to that of cardiac implantable electronic devices.",2019,"Mean procedure time was 2.7 ± 0.8 hours and 94% of patients were free from implant-related serious adverse events through 6 months.
",['147 of 151 (97%) patients were successfully implanted with the system'],"['phrenic nerve stimulator', 'Transvenous phrenic nerve stimulation', 'transvenous phrenic nerve stimulation']",['Mean procedure time'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0258211,"Mean procedure time was 2.7 ± 0.8 hours and 94% of patients were free from implant-related serious adverse events through 6 months.
","[{'ForeName': 'Ralph S', 'Initials': 'RS', 'LastName': 'Augostini', 'Affiliation': 'The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Muhammad R', 'Initials': 'MR', 'LastName': 'Afzal', 'Affiliation': 'The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Maria Rosa', 'Initials': 'MR', 'LastName': 'Costanzo', 'Affiliation': 'Advocate Heart Institute, Chicago, Illinois.'}, {'ForeName': 'Randy', 'Initials': 'R', 'LastName': 'Westlund', 'Affiliation': 'Respicardia Inc, Minnetonka, Minnesota.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stellbrink', 'Affiliation': 'Klinikum Bielefeld, Bielefeld, Delaware.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Gutleben', 'Affiliation': 'Ruhruniversität Bochum, Bad Oeynhausen, Delaware.'}, {'ForeName': 'Sanjaya', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ""Department of Cardiology, University of Missouri-Kansas City School of Medicine, Saint Luke's Mid-America Heart Institute, Kansas City, Missouri.""}, {'ForeName': 'Moeen', 'Initials': 'M', 'LastName': 'Saleem', 'Affiliation': 'Advocate Heart Institute, Chicago, Illinois.'}, {'ForeName': 'Timothy W', 'Initials': 'TW', 'LastName': 'Smith', 'Affiliation': 'Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Peterson', 'Affiliation': 'United Heart and Vascular Clinic, St Paul, Minnesota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Drucker', 'Affiliation': 'Novant Health Cardiology, Winston-Salem, North Carolina.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Merliss', 'Affiliation': 'Bryan Medical Center, Lincoln, Nebraska.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hayes', 'Affiliation': 'Marshfield Clinic, Marshfield, Wisconsin.'}, {'ForeName': 'Christen', 'Initials': 'C', 'LastName': 'Butter', 'Affiliation': 'Heart Center Brandenburg in Bernau/Berlin & Brandenburg Medical School, Bernau, Delaware.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Hutchinson', 'Affiliation': 'University of Arizona College of Medicine, Tucson, Arizona.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Jagielski', 'Affiliation': '4th Military Hospital, Wroclaw, Poland.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.13898']
2696,30920122,Exposure-Response Modeling and Simulation of Progression-Free Survival and Adverse Events of Sorafenib Treatment in Patients With Advanced Thyroid Cancer.,"Sorafenib is an oral multikinase inhibitor approved for the treatment of differentiated thyroid carcinoma (DTC), renal cell carcinoma, and hepatocellular carcinoma. In the phase III DECISION trial in patients with DTC, sorafenib exposure and the incidence of some adverse events (AEs) were higher than in previous trials; therefore, we analyzed exposure-response relationships, including progression-free survival (PFS) and selected AEs in patients with DTC. A novel, stratified prediction-corrected visual predictive check (pc-VPC) was developed to show robustness of the exposure-response relationships. Time-to-event simulations confirmed the benefit of the recommended dosing schedule of 800 mg/day: initial doses of 800 mg/day were associated with the highest PFS, whereas lower doses (600 or 400 mg/day) were associated with improved tolerability but reduced PFS. A simulated dose-reduction strategy of 800 mg/day for an initial two cycles followed by dose reductions seemed likely to maintain efficacy while possibly mitigating selected AEs (e.g., diarrhea and hand-foot skin reactions).",2019,"A novel, stratified prediction-corrected visual predictive check (pc-VPC) was developed to show robustness of the exposure-response relationships.","['differentiated thyroid carcinoma (DTC), renal cell carcinoma, and hepatocellular carcinoma', 'Patients With Advanced Thyroid Cancer']",['Sorafenib'],['tolerability'],"[{'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0549473', 'cui_str': 'Thyroid Cancer'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}]",[],,0.0858117,"A novel, stratified prediction-corrected visual predictive check (pc-VPC) was developed to show robustness of the exposure-response relationships.","[{'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Grevel', 'Affiliation': 'BAST Inc. Ltd., Loughborough, UK.'}, {'ForeName': 'Garrit', 'Initials': 'G', 'LastName': 'Jentsch', 'Affiliation': 'BAST Inc. Ltd., Loughborough, UK.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Austin', 'Affiliation': 'BAST Inc. Ltd., Loughborough, UK.'}, {'ForeName': 'Nicolaas H', 'Initials': 'NH', 'LastName': 'Prins', 'Affiliation': 'qPharmetra, Nijmegen, The Netherlands.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lettieri', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, New Jersey, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mitchell', 'Affiliation': 'Mitchell Pharmaceutical Consulting, Lafayette, Colorado, USA.'}, {'ForeName': 'Funan', 'Initials': 'F', 'LastName': 'Huang', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, New Jersey, USA.'}, {'ForeName': 'Marcia S', 'Initials': 'MS', 'LastName': 'Brose', 'Affiliation': 'Department of Otorhinolaryngology: Head and Neck Surgery, Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schlumberger', 'Affiliation': 'Department of Nuclear Medicine and Endocrine Oncology, Institut Gustave Roussy and Université Paris Saclay, Villejuif, France.'}, {'ForeName': 'Gerold', 'Initials': 'G', 'LastName': 'Meinhardt', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, New Jersey, USA.'}, {'ForeName': 'Carol E A', 'Initials': 'CEA', 'LastName': 'Peña', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, New Jersey, USA.'}, {'ForeName': 'Bart A', 'Initials': 'BA', 'LastName': 'Ploeger', 'Affiliation': 'Bayer AG, Berlin, Germany.'}]",Clinical and translational science,['10.1111/cts.12634']
2697,32820647,"Recruitment, retention, and adherence in a clinical trial: The Pediatric Heart Network's Marfan Trial experience.","BACKGROUND/AIMS


The Pediatric Heart Network Marfan Trial was a randomized trial comparing atenolol versus losartan on aortic root dilation in 608 children and young adults with Marfan syndrome. Barriers to enrollment included a limited pool of eligible participants, restrictive entry criteria, and a diverse age range that required pediatric and adult expertise. Retention was complicated by a 3-year commitment to a complex study and medication regimen. The Network partnered with the Marfan Foundation, bridging the community with the research. The aims of this study are to report protocol and medication adherence and associated predictive factors, and to describe recruitment and retention strategies.
METHODS


Recruitment, retention, and adherence to protocol activities related to the primary outcome were measured. Retention was measured by percentage of enrolled participants with 3-year outcome data. Protocol adherence was calculated by completion rates of study visits, ambulatory electrocardiography (Holter monitoring), and quarterly calls. Medication adherence was assessed by the number of tablets or the amount of liquid in bottles returned. Centers were ranked according to adherence (high, medium, and low tertiles). Recruitment, retention, and adherence questionnaires were completed by sites. Descriptive statistics summarized recruitment, retention, and adherence, as well as questionnaire results. Regression modeling assessed predictors of adherence.
RESULTS


Completion rates for visits, Holter monitors, and quarterly calls were 99%, 94%, and 96%, respectively. Primary outcome data at 3 years were obtained for 88% of participants. The mean percentage of medication taken was estimated at 89%. Site and age were associated with all measures of adherence. Young adult and African American participants had lower levels of adherence. Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation's resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence.
CONCLUSION


Overall adherence was excellent for this trial conducted within a National Institutes of Health-funded clinical trial network. Strategies specifically targeted to young adults and African Americans may have been beneficial. Many strategies employed by higher adherence sites are ones that any site could easily use, such as greeting families at non-study hospital visits, asking for family feedback, providing calendars for tracking schedules, and recommending apps for medication reminders. Additional key learnings include adherence differences by age, race, and site, the value of collaborative learning, and the importance of partnerships with patient advocacy groups. These lessons could shape recruitment, retention, and adherence to improve the quality of future complex trials involving rare conditions.",2020,"Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation's resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence.
","['young adults and African Americans', 'Young adult and African American participants', 'eligible participants, restrictive entry criteria, and a diverse age range that required pediatric and adult expertise', '608 children and young adults with Marfan syndrome']","['losartan', 'atenolol']","['Medication adherence', 'Recruitment, retention, and adherence questionnaires', 'Retention', 'mean percentage of medication taken', 'Completion rates for visits, Holter monitors, and quarterly calls', 'completion rates of study visits, ambulatory electrocardiography (Holter monitoring), and quarterly calls', 'Recruitment, retention, and adherence', 'Protocol adherence', 'Overall adherence', 'lower levels of adherence']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}]","[{'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1290952', 'cui_str': 'Taking medication'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013801', 'cui_str': 'Electrocardiography, Holter'}, {'cui': 'C0332179', 'cui_str': 'Trimonthly'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013799', 'cui_str': 'Ambulatory ECG'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",608.0,0.169075,"Higher adherence sites employed more strategies; had more staffing resources, less key staff turnover, and more collaboration with referring providers; utilized the Foundation's resources; and used a greater number of strategies to recruit, retain, and promote protocol and medication adherence.
","[{'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Hamstra', 'Affiliation': ""Heart Institute Administration, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Pemberton', 'Affiliation': 'National Heart, Lung, and Blood Institute, NIH, Bethesda, MD, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Dagincourt', 'Affiliation': 'New England Research Institutes, Inc., Watertown, MA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Hollenbeck-Pringle', 'Affiliation': 'New England Research Institutes, Inc., Watertown, MA, USA.'}, {'ForeName': 'Felicia L', 'Initials': 'FL', 'LastName': 'Trachtenberg', 'Affiliation': 'New England Research Institutes, Inc., Watertown, MA, USA.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Cnota', 'Affiliation': ""Heart Institute Administration, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Atz', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Cappella', 'Affiliation': ""Ann and Robert H. Lurie Children's Hospital, Chicago, IL, USA.""}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'De Nobele', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Grima', 'Affiliation': 'The Marfan Foundation, Port Washington, NY, USA.'}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'King', 'Affiliation': ""Harvard Medical School, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Korsin', 'Affiliation': ""Children's Hospital of New York, New York, NY, USA.""}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Lambert', 'Affiliation': ""Primary Children's Hospital, University of Utah, Salt Lake City, UT, USA.""}, {'ForeName': 'Meghan K', 'Initials': 'MK', 'LastName': 'MacNeal', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Markham', 'Affiliation': ""The Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, TN, USA.""}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'MacCarrick', 'Affiliation': 'Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Sylvester', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Walter', 'Affiliation': 'Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Mingfen', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': 'Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Ronald V', 'Initials': 'RV', 'LastName': 'Lacro', 'Affiliation': ""Harvard Medical School, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774520945988']
2698,32820698,"Efficacy and safety of sodium RISedronate for glucocorticoid-induced OsTeoporosis with rheumaTOid arthritis (RISOTTO study): a multicentre, double-blind, randomized, placebo-controlled trial.","Objective:  No evidence has shown the efficacy of Sodium Risedronate (Risedronate) for glucocorticoid-induced osteoporosis (GIO) in patients with Rheumatoid arthritis (RA). The aim of this study was to explore the effectiveness and safety of Risedronate for GIO complicated with RA. Methods:  This was a six-month randomized, double-blind, placebo-controlled trial of 95 patients with GIO complicated with RA from 19 centers. The primary endpoint was the change from baseline in lumbar spine bone mineral density (L-BMD). Secondary endpoints included changes in femoral neck and total hip BMD and bone turnover markers, as well as rheumatoid arthritis Disease Activity Score with 28-joint counts. Incident of non-traumatic spine fractures and adverse events were tracked as safety endpoints. Results:  Increase in L-BMD was significantly greater in the Risedronate group compared to the Placebo group (Risedronate: 3.49% [95% CI: 1.92 to 5.05] vs Placebo: 0.12% [95% CI: -2.07 to 2.30], p <0.0001). No significant difference was found in femoral neck and total hip BMD. Although adverse events were observed in 28 patients, none were considered serious. Non-traumatic vertebral fractures were identified in 10 patients. Conclusions:  Risedronate was effective in increasing L-BMD and was well tolerated in patients with GIO complicated with RA.",2020,"Although adverse events were observed in 28 patients, none were considered serious. Non-traumatic vertebral fractures were identified in 10 patients.","['95 patients with GIO complicated with RA from 19 centers', 'patients with Rheumatoid arthritis (RA', 'patients with GIO complicated with RA']","['Placebo', 'Risedronate', 'Sodium Risedronate (Risedronate', 'sodium RISedronate', 'placebo']","['changes in femoral neck and total hip BMD and bone turnover markers, as well as rheumatoid arthritis Disease Activity Score with 28-joint counts', 'lumbar spine bone mineral density (L-BMD', 'femoral neck and total hip BMD', 'Efficacy and safety', 'effectiveness and safety', 'adverse events', 'L-BMD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0246719', 'cui_str': 'Risedronate'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C2732410', 'cui_str': 'Disease activity score in rheumatoid arthritis'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",95.0,0.580505,"Although adverse events were observed in 28 patients, none were considered serious. Non-traumatic vertebral fractures were identified in 10 patients.","[{'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Fujieda', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Graduate School of Medicine and Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Horita', 'Affiliation': 'Internal Medicine, Tomakomai City Hospital, Tomakomai, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Nishimoto', 'Affiliation': 'Department of Biostatistics, Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Tanimura', 'Affiliation': 'Hokkaido Medical Center for Rheumatic Diseases, Sapporo, Japan.'}, {'ForeName': 'Yoshiharu', 'Initials': 'Y', 'LastName': 'Amasaki', 'Affiliation': 'Department of Rheumatology, Tonan Hospital, Sapporo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Kasahara', 'Affiliation': 'Department of Rheumatology, NTT Sapporo Medical Center, Sapporo, Japan.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Furukawa', 'Affiliation': 'Internal Medicine, Kushiro Red Cross Hospital, Kushiro, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Takeda', 'Affiliation': 'Internal Medicine, Hokkaido Spinal Cord Injury Center, Bibai, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Fukaya', 'Affiliation': '3rd Department of Internal Medicine, Obihiro Kosei Hospital, Obihiro, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Matsui', 'Affiliation': 'Internal Medicine, Takikawa City Hospital, Takikawa, Japan.'}, {'ForeName': 'Akito', 'Initials': 'A', 'LastName': 'Tsutsumi', 'Affiliation': 'Internal Medicine, Takikawa City Hospital, Takikawa, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Furusaki', 'Affiliation': 'Sagawa Akira Rheumatology Clinic, Sapporo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Sagawa', 'Affiliation': 'Sagawa Akira Rheumatology Clinic, Sapporo, Japan.'}, {'ForeName': 'Kou', 'Initials': 'K', 'LastName': 'Katayama', 'Affiliation': 'Katayama Orthopaedic Rheumatology Clinic, Asahikawa, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Takeuchi', 'Affiliation': 'Aozora Takeuchi Internal Medicine Clinic, Sapporo, Japan.'}, {'ForeName': 'Kazuaki', 'Initials': 'K', 'LastName': 'Katsumata', 'Affiliation': 'Department of Rheumatology, Teine Keijinkai Hospital, Sapporo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kurita', 'Affiliation': 'Internal Medicine, Kitami Red Cross Hospital, Kitami, Japan.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Shane', 'Affiliation': 'International Medical Department, Hokkaido University Hospital, Sapporo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Graduate School of Medicine and Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Oku', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Graduate School of Medicine and Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Yasuda', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Graduate School of Medicine and Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Takahata', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medicine and Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Norimasa', 'Initials': 'N', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medicine and Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Atsumi', 'Affiliation': 'Department of Rheumatology, Endocrinology and Nephrology, Graduate School of Medicine and Faculty of Medicine, Hokkaido University, Sapporo, Japan.'}]",Modern rheumatology,['10.1080/14397595.2020.1812835']
2699,32820820,Pulmonary Metastasectomy in Colorectal Cancer: the PulMiCC randomised controlled trial.,,2020,,['Colorectal Cancer'],[],[],"[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",[],[],,0.176723,,"[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Treasure', 'Affiliation': 'Clinical Operational Research Unit, University College London, Sremska Kamenica, Serbia.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Leonard', 'Affiliation': 'Barking, Havering and Redbridge University Hospitals NHS Trust, Sremska Kamenica, Serbia.'}, {'ForeName': 'Misel', 'Initials': 'M', 'LastName': 'Milosevic', 'Affiliation': 'Institute for Lung Diseases of Vojvodina, Sremska Kamenica, Serbia.'}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Surgical and Interventional Trials Unit, University College London.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Macbeth', 'Affiliation': 'Centre for Trials Research, Cardiff University.'}, {'ForeName': 'Vern', 'Initials': 'V', 'LastName': 'Farewell', 'Affiliation': 'MRC Biostatistics Unit, Cambridge University.'}]",The British journal of surgery,['10.1002/bjs.11948']
2700,32820838,Achieving energy balance with a high-fat meal does not enhance skeletal muscle adaptation and impairs glycemic response in a sleep-low training model.,"NEW FINDINGS


What is the central question of this study? Does achieving energy balance mainly with ingested fat in a 'sleep-low' model of training with low muscle glycogen affect the early training adaptive response during recovery? What is the main finding and its importance? Replenishing the energy expended during exercise mainly from ingested fat to achieve energy balance in a 'sleep-low' model does not enhance the response of skeletal muscle markers of early adaptation to training and impairs glycaemic control the morning after compared to training with low energy availability. These findings are important for optimising post-training dietary recommendations in relation to energy balance and macronutrient intake.
ABSTRACT


Training with low carbohydrate availability (LCHO) has shown to acutely enhance endurance training skeletal muscle response, but concomitant energy deficit (ED) in LCHO interventions has represented a confounding factor in past research. This study aimed at determining if achieving energy balance with high-fat (EB-HF) acutely enhances the adaptive response in LCHO compared to ED low-fat (ED-LF). In a crossover design, nine well-trained males completed a 'sleep-low' protocol: on day 1 they cycled to deplete muscle glycogen while reaching a set energy expenditure (30 kcal/kg of fat free mass (FFM)). Post-exercise, low carbohydrate, protein-matched meals completely (EB-HF, 30 kcal/kg FFM) or partially (ED-LF, 9 kcal/kg FFM) replaced the energy expended, with the majority of energy derived from fat in EB-HF. In the morning of day 2, participants exercised fasted and skeletal muscle and blood samples were collected and a carbohydrate-protein drink was ingested at 0.5h recovery. Muscle glycogen showed no treatment effect (P < 0.001) and decreased from 350 ±98 and 192 ±94 mmol/kg dry-mass between rest and 0.5 h recovery. Phosphorylation status mTOR and AMPK pathway proteins showed only time effects. mRNA expression of p53 increased after exercise (P = 0.005) and was higher in ED-LF at 3.5h compared to EB-HF (P = 0.027). Plasma glucose and insulin AUC (P < 0.04) and peak values (P≤0.05) were higher in EB-HF after the recovery drink. Achieving energy balance with a high-fat meal in a 'train-low' ('sleep-low') model did not enhance markers of skeletal muscle adaptation and impaired glycemia in response to a recovery drink following training in the morning. This article is protected by copyright. All rights reserved.",2020,mRNA expression of p53 increased after exercise (P = 0.005) and was higher in ED-LF at 3.5h compared to EB-HF (P = 0.027).,[],"['low carbohydrate availability (LCHO', ""sleep-low' protocol: on day 1 they cycled to deplete muscle glycogen while reaching a set energy expenditure"", 'Post-exercise, low carbohydrate, protein-matched meals completely (EB-HF, 30\xa0kcal/kg FFM']","['mRNA expression of p53 increased after exercise', 'peak values', 'skeletal muscle adaptation and impairs glycemic response', 'Plasma glucose and insulin AUC (P']",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}]","[{'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.0267765,mRNA expression of p53 increased after exercise (P = 0.005) and was higher in ED-LF at 3.5h compared to EB-HF (P = 0.027).,"[{'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Areta', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Juma', 'Initials': 'J', 'LastName': 'Iraki', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Owens', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Joanisse', 'Affiliation': 'Department of Kinesiology, McMaster University, Hamilton, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Philp', 'Affiliation': 'Mitochondrial Metabolism and Ageing Laboratory, Diabetes and Metabolism Division, Garvan Institute of Medical Research, Darlinghurst, Australia.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Morton', 'Affiliation': 'Research Institute for Sport and Exercise Sciences, Liverpool John Moores University, Liverpool, United Kingdom.'}, {'ForeName': 'Jostein', 'Initials': 'J', 'LastName': 'Hallén', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, Oslo, Norway.'}]",Experimental physiology,['10.1113/EP088795']
2701,32820846,Efficacy of whitening toothpaste containing blue covarine: A double-blind controlled randomized clinical trial.,"OBJECTIVE


This randomized clinical trial evaluated the efficacy and safety of a blue-covarine whitening toothpaste on tooth bleaching.
SUBJECTS AND METHODS


Seventy-five subjects with shade mean C1 or darker were randomized into three groups (n = 25): CT-conventional toothpaste, WT-whitening toothpaste, and CP10-10% carbamide peroxide. Subjects from CT and WT brushed their teeth twice/day for 2 weeks. CP10 used bleaching gel for 4 hours/night for 2 weeks. Tooth shade and CIELab parameters were measured at baseline, after the first application, 2- and 4-week. ΔE* ab  and ΔE 00  were calculated. Subjects' perception about tooth color appearance, tooth sensitivity (TS), and gingival irritation (GI) were also assessed.
RESULTS


At all evaluation periods, it was not observed differences between WT and CT considering tooth shade (P > 0.7) or CIELab parameters (P > 0.3). At 2- and 4-week, ΔE* ab  and ΔE 00  were higher for CP10 than WT or CT (P = 0.001). WT and CT reported major dissatisfaction with tooth color appearance than CP10 (P = 0.001). At 1- and 2-week, WT experienced GI and TS similar to CT, both lower than CP10 (P < 0.01).
CONCLUSION


There were no significant differences in the whitening efficacy between whitening and conventional toothpastes. Neither of the dentifrices was as effective as at-home bleaching.
CLINICAL SIGNIFICANCE


The silica-based toothpaste containing blue covarine evaluated in this study did not give significant tooth whitening benefits over 2 weeks of use.",2020,"At all evaluation periods, it was not observed differences between WT and CT considering tooth shade (P > 0.7) or CIELab parameters (P > 0.3).",['Seventy-five subjects with shade mean C1 or darker were randomized into three groups (n = 25'],"['CT-conventional toothpaste, WT-whitening toothpaste, and CP10-10% carbamide peroxide', 'WT and CT', 'whitening toothpaste containing blue covarine', 'blue-covarine whitening toothpaste', 'CP10 used bleaching gel']","['whitening efficacy', ""Subjects' perception about tooth color appearance, tooth sensitivity (TS), and gingival irritation (GI"", 'Tooth shade and CIELab parameters', 'efficacy and safety', 'Efficacy']","[{'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332582', 'cui_str': 'Dark color'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C2606445', 'cui_str': 'blue covarine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0475833', 'cui_str': 'Tooth color'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0011432', 'cui_str': 'Sensitive dentin'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",75.0,0.0268266,"At all evaluation periods, it was not observed differences between WT and CT considering tooth shade (P > 0.7) or CIELab parameters (P > 0.3).","[{'ForeName': 'Sônia Saeger', 'Initials': 'SS', 'LastName': 'Meireles', 'Affiliation': 'Department of Operative Dentistry, Federal University of Paraiba, João Pessoa, Paraiba, Brazil.'}, {'ForeName': 'Jossaria Pereira', 'Initials': 'JP', 'LastName': 'de Sousa', 'Affiliation': 'Department of Dentistry, State University of Paraíba, Campina Grande, Paraiba, Brazil.'}, {'ForeName': 'Rodrigo Barros Esteves', 'Initials': 'RBE', 'LastName': 'Lins', 'Affiliation': 'PhD student in Restorative Dentistry, University of Campinas - Piracicaba Dental School, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Fábio Correia', 'Initials': 'FC', 'LastName': 'Sampaio', 'Affiliation': 'Department of Clinical and Social Dentistry, Federal University of Paraiba, João Pessoa, Paraiba, Brazil.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12605']
2702,32821083,A Randomized Fellow-Eye Clinical Trial to Evaluate Patient Preference for Dexamethasone Intracanalicular Insert or Topical Prednisolone Acetate for Control of Postoperative Symptoms Following Bilateral Femtosecond Laser in Site Keratomileusis (LASIK).,"Purpose


To determine the preference of patients undergoing bilateral LASIK for either the dexamethasone intracanalicular insert or topical prednisolone acetate for control of postoperative symptoms and ocular surface signs.
Methods


In this randomized clinical trial, one eye was randomized to receive the dexamethasone insert or topical prednisolone acetate 1% four times daily for one week and 2 times daily for a second week; the fellow eye received the alternate therapy. One month postoperatively, patient preference for these two therapies was assessed using an adapted COMTOL questionnaire. Ocular comfort was assessed using the SPEED questionnaire. Corneal staining and uncorrected distance visual acuity (UDVA) were also assessed.
Results


Twenty patients participated. At Month 1, 80% of patients preferred the dexamethasone insert, 10% preferred prednisolone acetate, and 10% expressed no preference (p<0.001). SPEED scores measuring ocular comfort/discomfort related to dry eye symptoms were similar between groups (p=0.72), and both the incidence of patient-reported ocular dryness and the corneal staining scores were similar between groups. Both groups attained the same final UDVA.
Conclusion


Patients undergoing elective bilateral femtosecond LASIK surgery overwhelmingly (by an 8-to-1 margin) preferred the dexamethasone insert to topical prednisolone acetate for postoperative treatment. The insert produced comparable ocular comfort, corneal staining, and visual acuity outcomes to topical prednisolone. The insert is an appropriate means of postoperative symptom control in this quality of life-conscious population.",2020,"SPEED scores measuring ocular comfort/discomfort related to dry eye symptoms were similar between groups (p=0.72), and both the incidence of patient-reported ocular dryness and the corneal staining scores were similar between groups.","['Control of Postoperative Symptoms Following Bilateral Femtosecond Laser in Site Keratomileusis (LASIK', 'Twenty patients participated', 'patients undergoing bilateral LASIK for either the']","['elective bilateral femtosecond LASIK surgery', 'dexamethasone', 'prednisolone acetate', 'prednisolone', 'Dexamethasone Intracanalicular Insert or Topical Prednisolone Acetate', 'topical prednisolone acetate', 'dexamethasone intracanalicular insert or topical prednisolone acetate']","['SPEED scores measuring ocular comfort/discomfort related to dry eye symptoms', 'ocular comfort, corneal staining, and visual acuity outcomes', 'ocular dryness and the corneal staining scores', 'Corneal staining and uncorrected distance visual acuity (UDVA', 'Ocular comfort']","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0339022', 'cui_str': 'Keratomileusis'}, {'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0752094', 'cui_str': 'Laser assisted in situ keratomileusis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0071839', 'cui_str': 'Prednisolone acetate'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0423232', 'cui_str': 'Corneal epithelial staining pattern'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}]",20.0,0.116557,"SPEED scores measuring ocular comfort/discomfort related to dry eye symptoms were similar between groups (p=0.72), and both the incidence of patient-reported ocular dryness and the corneal staining scores were similar between groups.","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Greenwood', 'Affiliation': 'Vance Thompson Vision, West Fargo, ND, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Gorham', 'Affiliation': 'Ektropia Solutions LLC, Laguna Beach, CA, USA.'}, {'ForeName': 'Keeley R', 'Initials': 'KR', 'LastName': 'Boever', 'Affiliation': 'Ektropia Solutions LLC, Laguna Beach, CA, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S265311']
2703,32821089,Hormonal Function Responses to Moderate Aerobic Exercise in Older Adults with Depression.,"Background


Poor daily life physical activities among older people were related to depressive mood especially memory loss. In addition to that, the change in physical ability is significantly associated with the score of depression among older age.
Objective


The present study aimed to evaluate the effects of a supervised aerobic training program with moderate intensity for 12 weeks on mood profiles and hormonal levels of the hypothalamus-pituitary-adrenal axis (HPA axis) of older adults.
Methods


A total of 80 individuals of both gender (90 males, 110 females) of ages ranged between 65 and 95 years were recruited for this study. Based upon the profile of mood states (POMS) analysis, the participants were classified into two groups: control group (n=30) and depressive group (n=50). Leisure-time physical activity (LTPA), adrenal hormones such as ACTH, corticosterone (CORT), cortisol, DHEA/S, and cortisol:DHEA/S ratio were measured at baseline and post-intervention of moderate aerobic exercise for 12 weeks.
Results


Older adults with higher depressive scores showed a remarkable change in the level of adrenal hormones compared to control. There was a significant increase in the level of ACTH, CORT, cortisol, and cortisol:DHEA/S ratio, and decrease in DHEA/S. Compared to females, males showed an improvement in depressive mood score along with an increase in LPTA, DHEA/S and decrease in ACTH, CORT, cortisol, cortisol:DHEA/S ratio following 12 weeks of supervised aerobic training, respectively.
Conclusion


The findings of this study showed that 12 weeks of supervised exercise interventions are promising non-drug therapeutic strategies in improving depression among older adults. The potential performance in a psychological state occurs physiologically via optimizing the levels of the hormones of the HPA axis.",2020,"There was a significant increase in the level of ACTH, CORT, cortisol, and cortisol:DHEA/S ratio, and decrease in DHEA/S. Compared to females, males showed an improvement in depressive mood score along with an increase in LPTA, DHEA/S and decrease in ACTH, CORT, cortisol, cortisol:","['older adults', '80 individuals of both gender (90 males, 110 females) of ages ranged between 65 and 95 years', 'older people', 'participants were classified into two groups: control group (n=30) and depressive group (n=50', 'Older Adults with Depression']","['Hormonal Function Responses to Moderate Aerobic Exercise', 'supervised exercise interventions', 'supervised aerobic training program']","['depressive mood score', 'level of ACTH, CORT, cortisol, and cortisol:DHEA/S ratio, and decrease in DHEA/S', 'LPTA, DHEA/S and decrease in ACTH, CORT, cortisol, cortisol', 'level of adrenal hormones', 'mood profiles and hormonal levels of the hypothalamus-pituitary-adrenal axis (HPA axis', 'Leisure-time physical activity (LTPA), adrenal hormones such as ACTH, corticosterone (CORT), cortisol, DHEA/S, and cortisol:DHEA/S ratio']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}, {'cui': 'C0010124', 'cui_str': 'Corticosterone'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1445654', 'cui_str': 'Adrenal hormone'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0348598,"There was a significant increase in the level of ACTH, CORT, cortisol, and cortisol:DHEA/S ratio, and decrease in DHEA/S. Compared to females, males showed an improvement in depressive mood score along with an increase in LPTA, DHEA/S and decrease in ACTH, CORT, cortisol, cortisol:","[{'ForeName': 'Ahmad H', 'Initials': 'AH', 'LastName': 'Alghadir', 'Affiliation': 'Rehabilitation Research Chair (RRC), College of Applied Medical Sciences (CAMS), King Saud University, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Sami A', 'Initials': 'SA', 'LastName': 'Gabr', 'Affiliation': 'Rehabilitation Research Chair (RRC), College of Applied Medical Sciences (CAMS), King Saud University, Riyadh, Kingdom of Saudi Arabia.'}]",Clinical interventions in aging,['10.2147/CIA.S259422']
2704,32821109,A Randomized Controlled Trial Comparing Analgesic Efficacies of an Ultrasound-Guided Approach with and without a Combined Pressure Measurement Technique for Thoracic Paravertebral Blocks After Open Thoracotomy.,"Purpose


Ultrasound-guided thoracic paravertebral block (TPVB) is an established means for providing postoperative analgesia in thoracic surgery. However, there are conflicting results regarding the efficacy of post-thoracotomy pain management of ultrasound-guided TPVB when compared with that using traditional landmark approach. We therefore conducted a comparative study to evaluate the analgesic efficacy of TPVB when pressure measurement during needle advancement is combined with an ultrasound-guided approach.
Patients and Methods


The patients scheduled for lobectomy through thoracotomy were randomly allocated to receive either the ultrasound-guided approach only group (U group) or the ultrasound-guided approach combined with pressure measurement group (UP group) (n = 36 per group). Before thoracic muscle closure, 0.375% ropivacaine (20 mL) was administered as a bolus, followed by a continuous infusion of 0.2% ropivacaine (0.1 mL/kg/hr) in both groups. Postoperative pain was assessed using the visual analogue scale (VAS) pain score while resting and coughing. Local anesthetics and pethidine usage and sensory block area were also evaluated.
Results


The UP group showed significantly lower VAS scores, local anesthetics and pethidine usage, and a wider sensory block area than the U group.
Conclusion


A combined technique with ultrasound guidance and pressure measurement provided a superior analgesic effect over that of an ultrasound-guided approach alone for the management of post-thoracotomy pain.",2020,"The UP group showed significantly lower VAS scores, local anesthetics and pethidine usage, and a wider sensory block area than the U group.
","['thoracic surgery', 'patients scheduled for lobectomy through thoracotomy']","['Ultrasound-Guided Approach with and without a Combined Pressure Measurement Technique for Thoracic Paravertebral Blocks', 'ropivacaine', 'Ultrasound-guided thoracic paravertebral block (TPVB', 'ultrasound-guided approach only group (U group) or the ultrasound-guided approach combined with pressure measurement group (UP group', 'TPVB']","['Postoperative pain', 'VAS scores, local anesthetics and pethidine usage, and a wider sensory block area', 'visual analogue scale (VAS) pain score while resting and coughing']","[{'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0039991', 'cui_str': 'Chest wall incision'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0442150', 'cui_str': 'Paravertebral'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}]",,0.0605639,"The UP group showed significantly lower VAS scores, local anesthetics and pethidine usage, and a wider sensory block area than the U group.
","[{'ForeName': 'Eun Kyung', 'Initials': 'EK', 'LastName': 'Choi', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Ji-Il', 'Initials': 'JI', 'LastName': 'Kim', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Sang-Jin', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea.'}]",Therapeutics and clinical risk management,['10.2147/TCRM.S263353']
2705,32821177,Impact of Intraoperative Fluid Management on Electrolyte and Acid-Base Variables During Posterior Spinal Fusion in Adolescents.,"Introduction


Various isotonic fluids may be used to maintain intravascular homeostasis during major surgical procedures. Variations in the electrolyte and buffer concentrations between these solutions may result in differential changes in electrolyte and acid-base status during fluid resuscitation. This study evaluates these changes during posterior spinal fusion in adolescents.
Methods


Patients were randomized to receive lactated Ringers (LR), normal saline (NS) or Normosol-R® (NR) during posterior spinal fusion (N=19, 20, and 20, respectively). The specific fluid was used for maintenance fluids as well as fluid replacement of deficits, third space losses, and blood loss.
Results


Patients who received NS had a greater base deficit (NS: -2.0 ± 2.2 vs NR -0.6 ± 1.8, p=0.031 or LR: -0.2 ± 1.7, p=0.007) and were more likely to have a ≥2 point change in the base deficit (60% with NS compared to 30% with NR and 47% with LR). Patients receiving NS also had a lower pH (NS: 7.37 ± 0.03 vs NR: 7.39 ± 0.04, p=0.013) and a greater change in pH (NS: -0.03 ± 0.04 vs NR: 0.01 ± 0.06).
Conclusion


The use of NS for intraoperative resuscitation during posterior spinal fusion in adolescents resulted in a greater base deficit and a lower pH than the use of LR or NR. Although these changes had limited clinical significance in our patient population, future studies are indicated to further investigate the potential clinical impact of these changes.",2020,The use of NS for intraoperative resuscitation during posterior spinal fusion in adolescents resulted in a greater base deficit and a lower pH than the use of LR or NR.,"['Adolescents', 'adolescents']","['Intraoperative Fluid Management', 'lactated Ringers (LR), normal saline (NS) or Normosol-R® (NR']",['Electrolyte and Acid-Base Variables'],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0553741', 'cui_str': 'Fluid balance regulation'}, {'cui': 'C0073385', 'cui_str': ""Lactated Ringer's Solution""}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0069013', 'cui_str': 'Normosol-R'}]","[{'cui': 'C0013832', 'cui_str': 'electrolytes'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.279124,The use of NS for intraoperative resuscitation during posterior spinal fusion in adolescents resulted in a greater base deficit and a lower pH than the use of LR or NR.,"[{'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'King', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Martin', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Miketic', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Beebe', 'Affiliation': ""Department of Orthopedic Surgery, Nationwide Children's Hospital and the Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Samora', 'Affiliation': ""Department of Orthopedic Surgery, Nationwide Children's Hospital and the Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Klamar', 'Affiliation': ""Department of Orthopedic Surgery, Nationwide Children's Hospital and the Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Tumin', 'Affiliation': 'Department of Pediatrics, Brody School of Medicine at East Carolina University, Greenville, NC, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tobias', 'Affiliation': ""Department of Anesthesiology & Pain Medicine, Nationwide Children's Hospital, Columbus, OH, USA.""}]",Orthopedic research and reviews,['10.2147/ORR.S262509']
2706,32821251,The Effects of a Recollection-Based Occupational Therapy Program of Alzheimer's Disease: A Randomized Controlled Trial.,"Considering the high socioeconomic costs related to the increasing number of dementia patients and their poor quality of life and that of their families, it is important to identify the condition early on and provide an appropriate intervention. This study organized a recollection-based occupational therapy program: a nonpharmacological intervention consisting of five categories of activities (physical, horticultural, musical, art, and instrumental activity of daily living; IADL) and applied it to those having a mild stage of Alzheimer's disease. The experimental group participated in a total of 24 sessions--five times per week for one hour per session--while the control group took part in regular activities offered by the existing facilities. The experimental group presented improved cognitive functions, reduced depression, and enhanced quality of life; the two groups showed a statistically significant difference in every category. This study is meaningful in that it made a cognitive stimulation program concerning five different categories, implemented it for people suffering mild dementia, and confirmed positive outcomes. If a systemic version of the program is offered in dementia care facilities, it is expected to make a considerable contribution to the care of dementia patients.",2020,"The experimental group presented improved cognitive functions, reduced depression, and enhanced quality of life; the two groups showed a statistically significant difference in every category.","[""Alzheimer's Disease""]","['Recollection-Based Occupational Therapy Program', 'activities (physical, horticultural, musical, art, and instrumental activity of daily living; IADL']","['cognitive functions, reduced depression, and enhanced quality of life']","[{'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0211207,"The experimental group presented improved cognitive functions, reduced depression, and enhanced quality of life; the two groups showed a statistically significant difference in every category.","[{'ForeName': 'DeokJu', 'Initials': 'D', 'LastName': 'Kim', 'Affiliation': 'Department of Occupational Therapy, Cheongju University, Daesung-ro, 298, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea.'}]",Occupational therapy international,['10.1155/2020/6305727']
2707,32821419,Prostaglandin insert dinoprostone versus trans-cervical balloon catheter for outpatient labour induction: a randomised controlled trial of feasibility (PROBIT-F).,"Background


The aim was to assess the feasibility of conducting a randomised controlled trial (RCT) of induction of labour comparing use of two methods in the outpatient setting.
Methods


An open-label feasibility RCT was conducted in two UK maternity units from October 2017 to March 2019. Women aged ≥ 16 years, undergoing induction of labour (IOL) at term, with intact membranes and deemed suitable for outpatient IOL according to local guidelines were considered eligible. They were randomised to cervical ripening balloon catheter (CRB) or vaginal dinoprostone (Propess). The participants completed a questionnaire and a sub-group underwent detailed interview. Service use and cost data were collected via the Adult Service Use Schedule (AD-SUS). Women who declined to participate were requested to complete a decliners' questionnaire.
Results


During the study period, 274 eligible women were identified. Two hundred thirty (83.9%) were approached for participation of whom 84/230 (36.5%) agreed and 146 did not. Of these, 38 were randomised to Propess ( n  = 20) and CRB ( n  = 18). Decliner data were collected for 93 women. The reasons for declining were declining IOL ( n  = 22), preference for inpatient IOL ( n  = 22) and preference for a specific method, Propess ( n  = 19). The intended sample size of 120 was not reached due to restrictive criteria for suitability for outpatient IOL, participant preference for Propess and shortage of research staff.The intervention as randomised was received by 29/38 (76%) women. Spontaneous vaginal delivery was observed in 9/20 (45%) women in the dinoprostone group and 11/18 (61%) women in the CRB group. Severe maternal adverse events were recorded in one woman in each group. All babies were born with good condition and all except one (37/38, 97.4%) remained with the mother after delivery. No deaths were recorded. - 21% of women in the dinoprostone group were re-admitted prior to diagnosis of active labour compared to 12% in the CRB group.
Conclusions


A third of the approached eligible women agreed for randomisation. An RCT is not feasible in the current service context. Modifications to the eligibility criteria for outpatient IOL, better information provision and round the clock availability of research staff would be needed to reach sufficient numbers.
Trial registration


NCT03199820. Registered on June 27, 2017.",2020,No deaths were recorded.,"['Women aged ≥\u200916\u2009years, undergoing induction of labour (IOL) at term, with intact membranes and deemed suitable for outpatient IOL according to local guidelines were considered eligible', '274 eligible women were identified', 'two UK maternity units from October 2017 to March 2019', '93 women', ""Women who declined to participate were requested to complete a decliners' questionnaire"", 'outpatient labour induction']","['dinoprostone', 'CRB', 'RCT', 'Prostaglandin insert dinoprostone', 'cervical ripening balloon catheter (CRB) or vaginal dinoprostone (Propess', 'trans-cervical balloon catheter']","['Spontaneous vaginal delivery', 're-admitted prior to diagnosis of active labour', 'Severe maternal adverse events']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0426199', 'cui_str': 'Intact membranes'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1136454', 'cui_str': 'Refusal to Participate'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C2931258', 'cui_str': 'Amaurosis congenita of Leber, type 1'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1960759', 'cui_str': 'Cervical ripening with balloon'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter'}]","[{'cui': 'C0269694', 'cui_str': 'Normal delivery procedure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0233081', 'cui_str': 'Normal labor'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",274.0,0.118362,No deaths were recorded.,"[{'ForeName': 'Amarnath', 'Initials': 'A', 'LastName': 'Bhide', 'Affiliation': ""Fetal Medicine Unit, St. George's University Hospital Foundation Trust, Blackshaw Road, London, SW17 0QT UK.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Sedgwick', 'Affiliation': ""St George's, University of London, London, UK.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Barrett', 'Affiliation': ""King's Clinical Trials Unit, London, UK.""}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Cupples', 'Affiliation': ""Fetal Medicine Unit, St. George's University Hospital Foundation Trust, Blackshaw Road, London, SW17 0QT UK.""}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Coates', 'Affiliation': 'City, University of London, London, UK.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Goode', 'Affiliation': ""Maternity Voices Partnership Chair, St. George's University Hospital Foundation Trust, London, UK.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Linton', 'Affiliation': ""Fetal Medicine Unit, St. George's University Hospital Foundation Trust, Blackshaw Road, London, SW17 0QT UK.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'McCourt', 'Affiliation': 'City, University of London, London, UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00661-7']
2708,32821420,Peer navigation for individuals with serious mental illness leaving jail: a pilot randomized trial study protocol.,"Background


Serious mental illness (SMI) is a prevalent public health problem affecting 25% of individuals in jail. Re-entry to the community following incarceration is a vulnerable time for justice-involved individuals with SMI. SMI requires prompt and ongoing access to mental health and other healthcare services.
Methods


The study will (1) develop a Mentoring And Peer Support (MAPS) intervention for post-release mental health and other service connection among jailed individuals with SMI and (2) pilot test the MAPS intervention to determine its feasibility and acceptability. The primary outcomes will be to evaluate the feasibility and acceptability of the proposed recruitment methods and research design, of the intervention training methods, and of delivering the enhanced peer-navigator and control interventions. Study samples include focus groups (n=36), open trial (n=15), and a randomized pilot trial in a sample of 40 individuals with SMI re-entering the community after jail release. Secondary outcomes will include post-release enrollment in mental health, medical care, and substance use services. We will also evaluate reduction in psychiatric symptoms, improvements in functioning, adherence to psychiatric medications, fewer substance using days, fewer hospitalizations and suicide attempts, nights unstably housed, and time until rearrest.
Discussion


This pilot study will evaluate the feasibility and acceptability of a peer navigation intervention for individuals with serious mental illness leaving jails. The study will serve as a formative work for a larger randomized controlled trial assessing the effectiveness of peer navigator intervention for (include the primary outcome) in this population.",2020,This pilot study will evaluate the feasibility and acceptability of a peer navigation intervention for individuals with serious mental illness leaving jails.,"['jailed individuals with SMI and (2', 'individuals with serious mental illness leaving jail', 'individuals with serious mental illness leaving jails', '40 individuals with SMI re-entering the community after jail release']","['peer navigation intervention', 'Mentoring And Peer Support (MAPS) intervention', 'peer navigator intervention', 'Peer navigation', 'MAPS intervention']","['feasibility and acceptability', 'feasibility and acceptability of the proposed recruitment methods and research design, of the intervention training methods, and of delivering the enhanced peer-navigator and control interventions', 'post-release enrollment in mental health, medical care, and substance use services']","[{'cui': 'C0033168', 'cui_str': 'Prisons'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0035171', 'cui_str': 'Research Design'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0557854', 'cui_str': 'Services'}]",40.0,0.181935,This pilot study will evaluate the feasibility and acceptability of a peer navigation intervention for individuals with serious mental illness leaving jails.,"[{'ForeName': 'Maji', 'Initials': 'M', 'LastName': 'Hailemariam', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Biology, College of Human Medicine, Michigan State University, East Lansing, MI USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Weinstock', 'Affiliation': 'Department of Psychiatry & Human Behavior, Alpert Medical School of Brown University, Providence, RI USA.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Johnson', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Biology, College of Human Medicine, Michigan State University, East Lansing, MI USA.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00659-1']
2709,32821422,Self-administration of medication during hospitalization-a randomized pilot study.,"Background


Self-administration of medication (SAM) during hospitalization is a complex intervention where patients are involved in their course of treatment. The study aim was to pilot test the SAM intervention. The objectives were to assess the feasibility of conducting a randomized controlled trial on the safety and cost-consequences of SAM during hospitalization.
Methods


The study was performed in a Danish cardiology unit.Patients ≥ 18 years capable of self-administering medication during hospitalization were eligible. Patients were excluded if they did not self-administer medication at home, were incapable of self-administering medication, were not prescribed medication suitable for self-administration, did not bring their medication, or were unable to speak Danish.Feasibility was assessed as part of the pilot study. A future randomized controlled trial was considered feasible if it was possible to recruit 60 patients within 3 months, if outcome measurement method was capable of detecting dispensing errors in both groups, and if patients in the intervention group were more satisfied with the medication management during hospitalization compared to the control group.Forty patients were recruited to gain experience about the intervention (self-administration). Additionally, 20 patients were randomized to the intervention or control group (nurse-led dispensing) to gain experience about the randomization procedure.Dispensing error proportions were based on data collected through disguised observation of patients and nurses during dispensing. The error proportion in the control group was used for the sample size calculation. Patient acceptability was assessed through telephone calls.
Results


Of the 60 patients recruited, one withdrew and 11 were discharged before observation resulting in analysis of 39 patients in the intervention group and nine in the control group. A dispensing error proportion of 3.4% was found in the intervention group and 16.1% in the control group. A total of 91.7% of patients in the intervention group and 66.7% in the control group were highly satisfied with the medication management during hospitalization. The overall protocol worked as planned. Minor changes in exclusion criteria, intervention, and outcome measures were considered.
Conclusions


It may be feasible to perform a pragmatic randomized controlled trial of the safety and cost-consequences of self-administration of medication during hospitalization.
Trial registration


ClinicalTrials.gov, NCT03541421, retrospectively registered on 30 May 2018.",2020,A dispensing error proportion of 3.4% was found in the intervention group and 16.1% in the control group.,"['20 patients', '60 patients within 3 months', 'Forty patients were recruited to gain experience about the intervention (self-administration', 'Patients were excluded if they did not self-administer medication at home, were incapable of self-administering medication, were not prescribed medication suitable for self-administration, did not bring their medication, or were unable to speak Danish', 'Patients ≥ 18\u2009years capable of self-administering medication during hospitalization were eligible']","['intervention or control group (nurse-led dispensing) to gain experience about the randomization procedure', '\n\n\nSelf-administration of medication (SAM', 'Self-administration of medication']",['Patient acceptability'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0564216', 'cui_str': 'Unable to speak'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",20.0,0.0824047,A dispensing error proportion of 3.4% was found in the intervention group and 16.1% in the control group.,"[{'ForeName': 'Charlotte Arp', 'Initials': 'CA', 'LastName': 'Sørensen', 'Affiliation': 'Hospital Pharmacy Central Denmark Region, Aarhus, Denmark.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Olesen', 'Affiliation': 'Hospital Pharmacy Central Denmark Region, Aarhus, Denmark.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Lisby', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Enemark', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'de Thurah', 'Affiliation': 'Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00665-3']
2710,32821423,Exploring community perceptions in preparation for a randomised controlled trial of biofortified flour in Pakistan.,"Background


Biofortification of staple food crops may be a cost-effective and sustainable approach to reducing micronutrient deficiencies in resource-poor settings with low dietary diversity. However, its success depends on uptake by the local population. This paper presents formative research conducted in a remote, rural community in North West Pakistan, prior to commencing a randomised controlled trial to test the effectiveness of consuming zinc-biofortified wheat flour for alleviating zinc deficiency. It explored local community members' knowledge, understanding and attitudes towards biofortification and views on members of their community taking part in the trial.
Methods


Four focus group discussions were conducted with male and female community members (separately for cultural reasons) and four in-depth interviews were conducted with Jirga members-respected male elders. Participation was limited to households that were ineligible for the trial so that we could explore the perspectives of community members who were not influenced by the incentives of the trial. Focus group participants were selected at community events for transparency. Data collection took place at the local school and homes of Jirga members. Thematic analysis was undertaken, using a combination of deductive and inductive approaches to identify key themes.
Results


A total of 47 men and women participated in this study. Participants reported clear motivation to access and consume more nutritious flour, believing this would bring health benefits, particularly to women and children. Trusted members of the local community, including Jirga members and female health workers, should be involved in providing information on biofortified flour (and the trial) to increase levels of awareness and acceptance. Without their involvement, there is a risk that biofortified flour would be mistrusted. The cost of flour is the main factor affecting purchasing decisions, and biofortified flour will need to be cost-competitive to achieve widespread uptake in marginalised, rural communities.
Conclusion


This formative study generated rich, qualitative data from a range of community stakeholders to improve the understanding of important barriers and facilitators to the widespread acceptability and adoption of biofortified wheat. Implementation research such as this will inform future decision-making in relation to scaling up biofortified wheat in Pakistan.",2020,"Trusted members of the local community, including Jirga members and female health workers, should be involved in providing information on biofortified flour (and the trial) to increase levels of awareness and acceptance.","['male and female community members (separately for cultural reasons) and four in-depth interviews were conducted with Jirga members-respected male elders', 'in Pakistan', 'Trusted members of the local community, including Jirga members and female health workers', '47 men and women participated in this study', 'remote, rural community in North West Pakistan']","['biofortified flour', 'consuming zinc-biofortified wheat flour']",[],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}]","[{'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0458980', 'cui_str': 'Wheat flour'}]",[],47.0,0.0817448,"Trusted members of the local community, including Jirga members and female health workers, should be involved in providing information on biofortified flour (and the trial) to increase levels of awareness and acceptance.","[{'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Mahboob', 'Affiliation': 'Khyber Medical University, Phase V, Hayatabad, Peshawar, Khyber Pakhtunkhwa Pakistan.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ohly', 'Affiliation': 'University of Central Lancashire, Preston, Lancashire PR1 2HE UK.'}, {'ForeName': 'Edward J M', 'Initials': 'EJM', 'LastName': 'Joy', 'Affiliation': 'London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Moran', 'Affiliation': 'University of Central Lancashire, Preston, Lancashire PR1 2HE UK.'}, {'ForeName': 'Mukhtiar', 'Initials': 'M', 'LastName': 'Zaman', 'Affiliation': 'Rehman Medical College, 5-B/2, Phase-V, Hayatabad, Peshawar, Khyber Pakhtunkhwa Pakistan.'}, {'ForeName': 'Nicola M', 'Initials': 'NM', 'LastName': 'Lowe', 'Affiliation': 'University of Central Lancashire, Preston, Lancashire PR1 2HE UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00664-4']
2711,32821503,Biofeedback Rehabilitation and Visual Cortex Response in Stargardt's Disease: A Randomized Controlled Trial.,"Purpose


to evaluate the effect of biofeedback (BF) rehabilitation on the visual function and on the activity of primary visual cortex (PVC) in patients with Stargardt's disease owing to mutations in the  ABCA4  gene (STGD1).
Methods


This was a single-center, controlled, randomized study. Twenty-four patients with STGD1 were randomized into two groups: a treatment group (TG) undergoing BF rehabilitation and a control group (CG). Treatment with BF consisted of a 10-minute session per eye performed weekly for 12 weeks. The subjects underwent a baseline and 3-month follow-up visits, including best-corrected visual acuity (BCVA), reading test, microperimetry, and functional magnetic resonance imaging (fMRI). The fMRI studies were acquired sequentially using a passive viewing condition and an active reading task. The primary outcomes were the change in the fMRI activation of primary visual cortex and the change in reading ability.
Results


After treatment, the patients in the TG were able to read smaller characters ( P  = 0.002) with a greater reading speed ( P  = 0.014) compared with patients in the CG. The fMRI studies showed a significant effect ( P  < 0.001) of BF on primary visual cortex activation in the TG compared with the CG. Finally, we observed significant ( P  < 0.05) improvements of best-corrected visual acuity, macular sensitivity, and fixation stability parameters in the TG compared with the CG.
Conclusions


Our study showed that visual rehabilitation using BF improved the usage of residual visual function in patients with STGD1.
Translational Relevance


Our findings show that the BF treatment compared with no treatment at all resulted in benefits. The specificity of the treatment could be examined to determine whether BF can be included in clinical practice.",2020,The fMRI studies showed a significant effect ( P  < 0.001) of BF on primary visual cortex activation in the TG compared with the CG.,"['patients with STGD1', ""Stargardt's Disease"", 'Twenty-four patients with STGD1', ""patients with Stargardt's disease owing to mutations in the  ABCA4  gene (STGD1""]","['treatment group (TG) undergoing BF rehabilitation and a control group (CG', 'biofeedback (BF) rehabilitation']","['best-corrected visual acuity, macular sensitivity, and fixation stability parameters', 'best-corrected visual acuity (BCVA), reading test, microperimetry, and functional magnetic resonance imaging (fMRI', 'residual visual function', 'Biofeedback Rehabilitation and Visual Cortex Response', 'fMRI activation of primary visual cortex and the change in reading ability', 'primary visual cortex activation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1855465', 'cui_str': 'Macular Dystrophy With Flecks, Type 1'}, {'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0042817', 'cui_str': 'Visual Cortex'}, {'cui': 'C0038446', 'cui_str': 'Area striata structure'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0586739', 'cui_str': 'Ability to read'}]",24.0,0.0587559,The fMRI studies showed a significant effect ( P  < 0.001) of BF on primary visual cortex activation in the TG compared with the CG.,"[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Melillo', 'Affiliation': 'Eye Clinic, Multidisciplinary Department of Medical, Surgical and Dental Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Prinster', 'Affiliation': 'Institute of Biostructure and Bioimaging, National Research Council, Naples, Italy.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Di Iorio', 'Affiliation': 'Eye Clinic, Multidisciplinary Department of Medical, Surgical and Dental Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Olivo', 'Affiliation': 'Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Francesco Maria', 'Initials': 'FM', 'LastName': ""D'Alterio"", 'Affiliation': 'Eye Clinic, Multidisciplinary Department of Medical, Surgical and Dental Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Sirio', 'Initials': 'S', 'LastName': 'Cocozza', 'Affiliation': 'Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Quarantelli', 'Affiliation': 'Institute of Biostructure and Bioimaging, National Research Council, Naples, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Testa', 'Affiliation': 'Eye Clinic, Multidisciplinary Department of Medical, Surgical and Dental Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Brunetti', 'Affiliation': 'Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Simonelli', 'Affiliation': 'Eye Clinic, Multidisciplinary Department of Medical, Surgical and Dental Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.'}]",Translational vision science & technology,['10.1167/tvst.9.6.6']
2712,32821675,Comparative 2-year outcomes of conventional and accelerated corneal collagen crosslinking in progressive keratoconus.,"AIM


To compare the safety and efficacy of conventional versus accelerated (9 mW/cm 2 ) corneal collagen crosslinking (CXL) in progressive keratoconus at the 2-year follow-up.
METHODS


In this prospective study, consecutive progressive keratoconus patients were randomized to receive either conventional CXL (CCXL) or accelerated CXL (ACXL; using hydroxypropyl methylcellulose-assisted riboflavin imbibition for 10min at 9 mW/cm 2 ). Visual, refractive, keratometric, topographic, and aberrometric outcomes and stromal demarcation line depth (DLD) measurements were compared at the end of a 2-year follow-up.
RESULTS


Thirty-two eyes from 32 patients in the CCXL and 27 eyes from 27 patients in the ACXL groups completed 2-year follow-up. At 2y post-CXL, both uncorrected and corrected visual acuities improved significantly in both groups. The improvements in keratometric readings, flattening rate (flattening of the maximum keratometry more than 1 D), 3 topographic indices, and vertical coma were significantly better in the CCXL group compared to the ACXL group ( P <0.05). The DLD as measured by anterior segment optical coherence tomography or  in vivo  confocal microscopy was better detectable and significantly deeper in the CCXL group compared to the ACXL group. The deeper DLD was found to be significantly correlated with improvements in the mean keratometry measurements. Progression was noted in 11.1% of eyes in the ACXL group, whereas progression was not observed in any patient eye in the CCXL group.
CONCLUSION


In this prospective randomized study, ACXL is less effective in halting the progression of keratoconus at a 2-year follow-up compared to CCXL.",2020,"Progression was noted in 11.1% of eyes in the ACXL group, whereas progression was not observed in any patient eye in the CCXL group.
","['progressive keratoconus', 'consecutive progressive keratoconus patients', 'Thirty-two eyes from 32 patients in the CCXL and 27 eyes from 27 patients in the ACXL groups completed 2-year follow-up']","['conventional CXL (CCXL) or accelerated CXL (ACXL; using hydroxypropyl methylcellulose-assisted riboflavin imbibition', 'CCXL', 'conventional versus accelerated (9 mW/cm 2 ) corneal collagen crosslinking (CXL', 'conventional and accelerated corneal collagen crosslinking', 'ACXL']","['keratometric readings, flattening rate (flattening of the maximum keratometry', 'corrected visual acuities', 'safety and efficacy', 'Progression', 'Visual, refractive, keratometric, topographic, and aberrometric outcomes and stromal demarcation line depth ', 'topographic indices, and vertical coma']","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0022578', 'cui_str': 'Keratoconus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0063242', 'cui_str': 'hypromellose'}, {'cui': 'C0035527', 'cui_str': 'Riboflavin'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0430885', 'cui_str': 'Keratometry'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0009421', 'cui_str': 'Coma'}]",32.0,0.029813,"Progression was noted in 11.1% of eyes in the ACXL group, whereas progression was not observed in any patient eye in the CCXL group.
","[{'ForeName': 'Ömür Ö', 'Initials': 'ÖÖ', 'LastName': 'Uçakhan', 'Affiliation': 'Department of Ophthalmology, Ankara University Faculty of Medicine, Ankara 06550, Turkey.'}, {'ForeName': 'Yağmur Seda', 'Initials': 'YS', 'LastName': 'Yeşiltaş', 'Affiliation': 'Department of Ophthalmology, Ankara University Faculty of Medicine, Ankara 06550, Turkey.'}]",International journal of ophthalmology,['10.18240/ijo.2020.08.07']
2713,32821700,Effect of Niacin on Carotid Atherosclerosis in Patients at Low-Density Lipoprotein-Cholesterol Goal but High Lipoprotein (a) Level: a 2-Year Follow-Up Study.,"Objective


To examine the effect of niacin on the progression of carotid intima-media thickness (IMT) in patients with high level of lipoprotein (Lp) (a).
Methods


Patients at low-density lipoprotein-cholesterol goal but with Lp (a) >25 mg/dL and mean carotid IMT >0.75 mm were included. Eligible patients were randomized at a 1:2 ratio into one of two groups for 24 months: control or 1,500 mg extended release niacin. The primary study outcomes were the percentage changes in mean and maximal carotid IMT. The percentage change in lipid profiles including Lp (a) was analyzed as a secondary study outcome.
Results


Among 96 randomized patients, 31 completed the study (mean age: 65 years; male: 44%). At follow-up, the percentage change in mean carotid IMT was not significantly different between the two groups (-1.4%±15.5% and -1.1%±7.3% in the control and niacin groups, respectively,  p =0.95). The percentage change in maximal carotid IMT was also similar in the two groups (0.7%±16.5% and -4.4%±11.6%, respectively,  p =0.35). Elevation of high-density lipoprotein-cholesterol tended to be higher in the niacin group ( p =0.07), and there was a significant difference in the percentage change in hemoglobin A1c between the two groups (-1.9%±2.2% and 3.3%±6.7%, respectively,  p =0.02). Reduction of Lp (a) was greater in the niacin-treated group compared to placebo, but the difference was not statistically significant.
Conclusion


Treatment with niacin for two years did not inhibit the progression of carotid intima-media thickening in patients with high Lp (a) level. However, this study may have been underpowered to evaluate the primary study outcome.",2019,"Elevation of high-density lipoprotein-cholesterol tended to be higher in the niacin group ( p =0.07), and there was a significant difference in the percentage change in hemoglobin A1c between the two groups (-1.9%±2.2% and 3.3%±6.7%, respectively,  p =0.02).","['Methods\n\n\nPatients at low-density lipoprotein-cholesterol goal but with Lp (a) >25 mg/dL and mean carotid IMT >0.75 mm were included', 'patients with high level of lipoprotein (Lp) (a', 'Patients at Low-Density Lipoprotein-Cholesterol Goal but High Lipoprotein', '96 randomized patients, 31 completed the study (mean age: 65 years; male: 44', 'Eligible patients']","['placebo', 'Niacin', 'niacin', 'control or 1,500 mg extended release niacin']","['hemoglobin A1c', 'Elevation of high-density lipoprotein-cholesterol', 'percentage changes in mean and maximal carotid IMT', 'Reduction of Lp (a', 'maximal carotid IMT', 'progression of carotid intima-media thickness (IMT', 'Carotid Atherosclerosis', 'progression of carotid intima-media thickening', 'mean carotid IMT']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0027996', 'cui_str': 'Niacin'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}]",96.0,0.192089,"Elevation of high-density lipoprotein-cholesterol tended to be higher in the niacin group ( p =0.07), and there was a significant difference in the percentage change in hemoglobin A1c between the two groups (-1.9%±2.2% and 3.3%±6.7%, respectively,  p =0.02).","[{'ForeName': 'Shinjeong', 'Initials': 'S', 'LastName': 'Song', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chan Joo', 'Initials': 'CJ', 'LastName': 'Lee', 'Affiliation': 'Department of Health Promotion, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jaewon', 'Initials': 'J', 'LastName': 'Oh', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sungha', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Seok-Min', 'Initials': 'SM', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang-Hak', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}]",Journal of lipid and atherosclerosis,['10.12997/jla.2019.8.1.58']
2714,32816002,Associations of Variation in Retinal Thickness With Visual Acuity and Anatomic Outcomes in Eyes With Neovascular Age-Related Macular Degeneration Lesions Treated With Anti-Vascular Endothelial Growth Factor Agents.,"Importance


When initiating anti-vascular endothelial growth factor (VEGF) treatment for patients with neovascular age-related macular degeneration (nAMD), knowledge of prognostic factors is important for advising patients and guiding treatment. We hypothesized that eyes with greater fluctuation in retinal thickness over time have worse outcomes than eyes with less variation.
Objective


To investigate whether visual and anatomic outcomes in eyes with nAMD initiating anti-VEGF treatment are associated with fluctuations in retinal thickness.
Design, Setting, and Participants


In this study using data from the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) and the Inhibition of VEGF in Age-Related Choroidal Neovascularization (IVAN) randomized clinical trial, people with previously untreated nAMD were included. Data were collected from February 2008 to November 2012, and data were analyzed from April 2017 to April 2020.
Main Outcomes and Measures


Foveal center point thicknesses (FCPTs) were extracted from 1165 study eyes from CATT and 566 study eyes from the IVAN trial, excluding those with 3 measurements or less. For each eye, the SD of FCPT was calculated. Eyes were grouped by FCPT SD quartile. Associations of FCPT SD quartile with outcomes were quantified at month 24 or the last available visit by linear or logistic regression, adjusting for baseline best-corrected visual acuity (BCVA) and randomized allocations to drug and treatment regimen, for BCVA, development of fibrosis, and development of macular atrophy.
Results


Of the 1731 included patients, 1058 (61.1%) were female, and the mean (SD) age was 78.6 (7.4) years. The median (interquartile range) FCPT SD was 40.2 (27.1-61.2) in the IVAN cohort and 59.0 (38.3-89.4) in the CATT cohort. After adjustment for baseline BCVA and trial allocations, BCVA worsened significantly across the quartiles of FCPT SD; the difference between the first and fourth quartiles was -6.27 Early Treatment Diabetic Retinopathy Study letters (95% CI, -8.45 to -4.09). The risk of developing fibrosis and macular atrophy also increased across FCPT SD quartiles. Odds ratios ranged from 1.40 (95% CI, 1.03 to 1.91) for quartile 2 to 1.95 (95% CI, 1.42 to 2.68) for quartile 4 for fibrosis and from 1.32 (95% CI, 0.90 to 1.92) for quartile 2 to 2.10 (95% CI, 1.45 to 3.05) for quartile 4 for macular atrophy.
Conclusions and Relevance


Greater variation in retinal thickness in eyes with nAMD during treatment with anti-VEGF was associated with worse BCVA and development of fibrosis and macular atrophy in these post hoc analyses, despite protocol-directed treatment frequency. Practitioners may want to consider variation in retinal thickness when advising patients about their prognosis.",2020,"Odds ratios ranged from 1.40 (95% CI, 1.03 to 1.91) for quartile 2 to 1.95 (95% CI, 1.42 to 2.68) for quartile 4 for fibrosis and from 1.32 (95% CI, 0.90 to 1.92) for quartile 2 to 2.10 (95% CI, 1.45 to 3.05) for quartile 4 for macular atrophy.
","['1731 included patients, 1058 (61.1%) were female, and the mean (SD) age was 78.6 (7.4) years', 'Data were collected from February 2008 to November 2012, and data were analyzed from April 2017 to April 2020', 'eyes with nAMD initiating anti-VEGF treatment', 'Age-Related Choroidal Neovascularization (IVAN) randomized clinical trial, people with previously untreated nAMD were included', 'patients with neovascular age-related macular degeneration (nAMD', 'Eyes With Neovascular Age-Related Macular Degeneration Lesions Treated With']","['anti-vascular endothelial growth factor (VEGF) treatment', 'Anti-Vascular Endothelial Growth Factor Agents']","['Measures\n\n\nFoveal center point thicknesses (FCPTs', 'risk of developing fibrosis and macular atrophy', 'median (interquartile range) FCPT SD']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0271084', 'cui_str': 'Exudative age-related macular degeneration'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0600518', 'cui_str': 'Choroidal neovascularisation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0423421', 'cui_str': 'Atrophic macular change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]",,0.209385,"Odds ratios ranged from 1.40 (95% CI, 1.03 to 1.91) for quartile 2 to 1.95 (95% CI, 1.42 to 2.68) for quartile 4 for fibrosis and from 1.32 (95% CI, 0.90 to 1.92) for quartile 2 to 2.10 (95% CI, 1.45 to 3.05) for quartile 4 for macular atrophy.
","[{'ForeName': 'Rebecca N', 'Initials': 'RN', 'LastName': 'Evans', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Barnaby C', 'Initials': 'BC', 'LastName': 'Reeves', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Martin', 'Affiliation': 'Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Muldrew', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}, {'ForeName': 'Tunde', 'Initials': 'T', 'LastName': 'Peto', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Rogers', 'Affiliation': 'Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Chakravarthy', 'Affiliation': ""Queen's University of Belfast, Royal Victoria Hospital, Belfast, Ireland.""}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.3001']
2715,32816021,The Effect of Platelet-Rich Fibrin Matrix on Skin Rejuvenation: A Split-Face Comparison.,"BACKGROUND


Despite the increasingly popular use of platelet-rich fibrin matrix (PRFM) for facial rejuvenation, no studies have evaluated its effects on skin.
OBJECTIVES


To determine the effect of PRFM on skin quality using the Canfield VISIA Complexion Analysis System.
METHODS


This was a 12-week randomized, placebo-controlled trial conducted at a single center comparing two groups. Thirty patients received a PRFM injection in the mid-cheek region and nasolabial fold on one side of the face and saline on the contralateral side. The primary outcome measure was the difference between pre- and post-treatment total VISIA skin scores for each group at 6 weeks and 12 weeks. The change in sub-scores for each skin parameter was also calculated.
RESULTS


There were thirty participants, with a mean (SD) age of 49.9 (13.9) years. At 6 weeks, the median decrease in total VISIA score (IQR) was -1.77 (2.36) in the PRFM group and -0.73 (2.09) in the saline group (p=0.003). The only skin parameter that had a significantly different change in score between the groups was texture (p=0.004). At 12 weeks, median score improvement was -1.31 (3.26) in the PRFM cohort and -0.76 (2.21) in the saline cohort (p=0.34). There was no statistical significance in the change in score for any of the individual skin parameters.
CONCLUSIONS


PRFM can objectively improve skin quality compared to placebo. Texture was the only skin parameter that significantly improved, which is consistent with PRFM's role as a filler agent. The results appear to persist for at least 6 weeks.",2020,The only skin parameter that had a significantly different change in score between the groups was texture (p=0.004).,"['thirty participants, with a mean (SD) age of 49.9 (13.9) years', 'Skin Rejuvenation', 'Thirty patients']","['Platelet-Rich Fibrin Matrix', 'PRFM', 'PRFM injection', 'platelet-rich fibrin matrix (PRFM', 'placebo']","['pre- and post-treatment total VISIA skin scores', 'median score improvement', 'total VISIA score (IQR', 'skin quality']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517562', 'cui_str': '13.9'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0035016', 'cui_str': 'Rejuvenation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",30.0,0.0863975,The only skin parameter that had a significantly different change in score between the groups was texture (p=0.004).,"[{'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Division of Facial Plastic Surgery, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bassiri-Tehrani', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Division of Facial Plastic Surgery, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Manoj T', 'Initials': 'MT', 'LastName': 'Abraham', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Division of Facial Plastic Surgery, Westchester Medical Center, New York, NY.'}]",Aesthetic surgery journal,['10.1093/asj/sjaa244']
2716,32816094,A 2 year physical activity and dietary intervention attenuates the increase in insulin resistance in a general population of children: the PANIC study.,"AIMS/HYPOTHESIS


We studied for the first time the long-term effects of a combined physical activity and dietary intervention on insulin resistance and fasting plasma glucose in a general population of predominantly normal-weight children.
METHODS


We carried out a 2 year non-randomised controlled trial in a population sample of 504 children aged 6-9 years at baseline. The children were allocated to a combined physical activity and dietary intervention group (306 children at baseline, 261 children at 2-year follow-up) or a control group (198 children, 177 children) without blinding. We measured fasting insulin and fasting glucose, calculated HOMA-IR, assessed physical activity and sedentary time by combined heart rate and body movement monitoring, assessed dietary factors by a 4 day food record, used the Finnish Children Healthy Eating Index (FCHEI) as a measure of overall diet quality, and measured body fat percentage (BF%) and lean body mass by dual-energy x-ray absorptiometry. The intervention effects on insulin, glucose and HOMA-IR were analysed using the intention-to-treat principle and linear mixed-effects models after adjustment for sex, age at baseline, and pubertal status at baseline and 2 year follow-up. The measures of physical activity, sedentary time, diet and body composition at baseline and 2 year follow-up were entered one-by-one as covariates into the models to study whether changes in these variables might partly explain the observed intervention effects.
RESULTS


Compared with the control group, fasting insulin increased 4.65 pmol/l less (absolute change +8.96 vs +13.61 pmol/l) and HOMA-IR increased 0.18 units less (+0.31 vs +0.49 units) over 2 years in the combined physical activity and dietary intervention group. The intervention effects on fasting insulin (regression coefficient β for intervention effect -0.33 [95% CI -0.62, -0.04], p = 0.026) and HOMA-IR (β for intervention effect -0.084 [95% CI -0.156, -0.012], p = 0.023) were statistically significant after adjustment for sex, age at baseline, and pubertal status at baseline and 2 year follow-up. The intervention had no effect on fasting glucose, BF% or lean body mass. Changes in total physical activity energy expenditure, light physical activity, moderate-to-vigorous physical activity, total sedentary time, the reported consumption of high-fat (≥60%) vegetable oil-based spreads, and FCHEI, but not a change in BF% or lean body mass, partly explained the intervention effects on fasting insulin and HOMA-IR.
CONCLUSIONS/INTERPRETATION


The combined physical activity and dietary intervention attenuated the increase in insulin resistance over 2 years in a general population of predominantly normal-weight children. This beneficial effect was partly mediated by changes in physical activity, sedentary time and diet but not changes in body composition.
TRIAL REGISTRATION


ClinicalTrials.gov NCT01803776 Graphical abstract.",2020,"Compared with the control group, fasting insulin increased 4.65 pmol/l less (absolute change +8.96 vs +13.61 pmol/l) and HOMA-IR increased 0.18 units less (+0.31 vs +0.49 units) over 2 years in the combined physical activity and dietary intervention group.","['general population of children', '2\xa0years in a general population of predominantly normal-weight children', 'a general population of predominantly normal-weight children', '2\xa0year non-randomised controlled trial in a population sample of 504 children aged 6-9\xa0years at baseline', 'group (306 children at baseline, 261 children at 2-year follow-up) or a control group (198 children, 177 children) without blinding']","['combined physical activity and dietary intervention', 'dietary intervention']","['insulin, glucose and HOMA-IR', 'HOMA-IR', 'insulin resistance', 'physical activity, sedentary time, diet and body composition', 'fasting insulin and fasting glucose, calculated HOMA-IR, assessed physical activity and sedentary time by combined heart rate and body movement monitoring, assessed dietary factors by a 4\xa0day food record, used the Finnish Children Healthy Eating Index (FCHEI) as a measure of overall diet quality, and measured body fat percentage (BF%) and lean body mass by dual-energy x-ray absorptiometry', 'fasting glucose, BF% or lean body mass', 'fasting insulin and HOMA-IR', 'physical activity, sedentary time and diet', 'fasting insulin', 'total physical activity energy expenditure, light physical activity, moderate-to-vigorous physical activity, total sedentary time, the reported consumption of high-fat', 'insulin resistance and fasting plasma glucose']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442751', 'cui_str': 'Distance vision 6/9'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0016134', 'cui_str': 'Finnish language'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}]",504.0,0.0393305,"Compared with the control group, fasting insulin increased 4.65 pmol/l less (absolute change +8.96 vs +13.61 pmol/l) and HOMA-IR increased 0.18 units less (+0.31 vs +0.49 units) over 2 years in the combined physical activity and dietary intervention group.","[{'ForeName': 'Timo A', 'Initials': 'TA', 'LastName': 'Lakka', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland. timo.lakka@uef.fi.'}, {'ForeName': 'Niina', 'Initials': 'N', 'LastName': 'Lintu', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Juuso', 'Initials': 'J', 'LastName': 'Väistö', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Viitasalo', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Taisa', 'Initials': 'T', 'LastName': 'Sallinen', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Eero A', 'Initials': 'EA', 'LastName': 'Haapala', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Tuomo T', 'Initials': 'TT', 'LastName': 'Tompuri', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Soininen', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Panu', 'Initials': 'P', 'LastName': 'Karjalainen', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Theresia M', 'Initials': 'TM', 'LastName': 'Schnurr', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Santtu', 'Initials': 'S', 'LastName': 'Mikkonen', 'Affiliation': 'Department of Applied Physics, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Atalay', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}, {'ForeName': 'Tuomas O', 'Initials': 'TO', 'LastName': 'Kilpeläinen', 'Affiliation': 'Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Tomi', 'Initials': 'T', 'LastName': 'Laitinen', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Kuopio University Hospital, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Laaksonen', 'Affiliation': 'Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Savonen', 'Affiliation': 'Department of Clinical Physiology and Nuclear Medicine, Kuopio University Hospital, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Soren', 'Initials': 'S', 'LastName': 'Brage', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Schwab', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Jarmo', 'Initials': 'J', 'LastName': 'Jääskeläinen', 'Affiliation': 'Department of Pediatrics, Institute of Clinical Medicine, Kuopio University Hospital and University of Eastern Finland, Kuopio, Finland.'}, {'ForeName': 'Virpi', 'Initials': 'V', 'LastName': 'Lindi', 'Affiliation': 'University of Eastern Finland Library Kuopio, Kuopio, Finland.'}, {'ForeName': 'Aino-Maija', 'Initials': 'AM', 'LastName': 'Eloranta', 'Affiliation': 'Institute of Biomedicine, School of Medicine, University of Eastern Finland, Kuopio Campus, P.O. Box 1627, FI-70211, Kuopio, Finland.'}]",Diabetologia,['10.1007/s00125-020-05250-0']
2717,32817701,Within-trial cost-effectiveness of lifestyle intervention using a 3-tier shared care approach for pregnancy outcomes in Chinese women with gestational diabetes.,"This study assessed within-trial cost-effectiveness of a shared care program (SC, n = 339) for pregnancy outcomes compared to usual care (UC, n = 361), as implemented in a randomized trial of Chinese women with gestational diabetes (GDM). SC consisted of an individualized dietary advice and physical activity counseling program. The UC was a one-time group education program. The effectiveness was measured by number needed to treat (NNT) to prevent one macrosomia/large for gestational age (LGA) infant. The cost-effectiveness was measured by incremental cost-effectiveness ratio in terms of cost (2012 Chinese Yuan/US dollar) per case of macrosomia and LGA prevented. The study took both a health care system and a societal perspective. This study found that the NNT was 16/14 for macrosomia/LGA. The incremental cost for treating a pregnant woman was ¥1,877 ($298) from a health care system perspective and ¥2,056 ($327) from a societal perspective. The cost of preventing a case of macrosomia/LGA from the two corresponding perspectives were ¥30,032/¥26,278 ($4,775/$4,178) and ¥32,896/¥28,784 ($5,230/$4,577), respectively. Considering the potential severe adverse health and economic consequences of a macrosomia/LGA infant, our findings suggest that implementing this lifestyle intervention for women with GDM is an efficient use of health care resources.",2020,"This study assessed within-trial cost-effectiveness of a shared care program (SC, n = 339) for pregnancy outcomes compared to usual care (UC, n = 361), as implemented in a randomized trial of Chinese women with gestational diabetes (GDM).","['women with GDM', 'Chinese women with gestational diabetes (GDM', 'Chinese women with gestational diabetes', 'pregnant woman was ¥1,877 ($298) from a health care system perspective and ¥2,056 ($327) from a societal perspective']","['NNT', 'shared care program (SC', 'lifestyle intervention using a 3-tier shared care approach', 'individualized dietary advice and physical activity counseling program']","['cost-effectiveness', 'cost of preventing a case of macrosomia/LGA']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0018696', 'cui_str': 'Healthcare Systems'}]","[{'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0158915', 'cui_str': 'Exceptionally large at birth'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}]",,0.0234859,"This study assessed within-trial cost-effectiveness of a shared care program (SC, n = 339) for pregnancy outcomes compared to usual care (UC, n = 361), as implemented in a randomized trial of Chinese women with gestational diabetes (GDM).","[{'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Cuiping', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Junhong', 'Initials': 'J', 'LastName': 'Leng', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Shao', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Huiguang', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Fuxia', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Dong', 'Affiliation': ""Tianjin Women and Children's Health Centre, Tianjin, China.""}, {'ForeName': 'Zhijie', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Population Cancer Research Program and Department of Pediatrics, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Juliana C N', 'Initials': 'JCN', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine and Therapeutics, Hong Kong Institute of Diabetes and Obesity and The Chinese University of Hong Kong-Prince of Wales Hospital-International Diabetes Federation Centre of Education, Hong Kong SAR, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Hu', 'Affiliation': 'Chronic Disease Epidemiology Laboratory, Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States of America.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Division of Diabetes Translation, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.'}, {'ForeName': 'Xilin', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China.'}]",PloS one,['10.1371/journal.pone.0237738']
2718,32817703,Effect of ventilation rate on recovery after cardiac arrest in a pediatric animal model.,"AIMS


To assess the impact of two different respiratory rates in hemodynamic, perfusion and ventilation parameters in a pediatric animal model of cardiac arrest (CA).
METHODS


An experimental randomized controlled trial was carried out in 50 piglets under asphyxial CA. After ROSC, they were randomized into two groups: 20 and 30 respirations per minute (rpm). Hemodynamic, perfusion and ventilation parameters were measured 10 minutes after asphyxia, just before ROSC and at 5, 15, 30 and 60 minutes after ROSC. Independent medians test, Kruskal-Wallis test and χ2 test, were used to compare continuous and categorical variables, respectively. Spearman's Rho was used to assess correlation between continuous variables. A p-value <0.05 was considered significant.
RESULTS


Arterial partial pressure of carbon dioxide (PaCO2) was significantly lower in the 30 rpm group after 15 minutes (41 vs. 54.5 mmHg, p <0.01), 30 minutes (39.5 vs. 51 mmHg, p < 0.01) and 60 minutes (36.5 vs. 48 mmHg, p = 0.02) of ROSC. The percentage of normoventilated subjects (PaCO2 30-50 mmHg) was significantly higher in the 30 rpm group throughout the experiment. pH normalization occurred faster in the 30 rpm group with significant differences at 60 minutes (7.40 vs. 7.34, p = 0.02). Lactic acid levels were high immediately after ROSC in both groups, but were significantly lower in the 20 rpm group at 30 (3.7 vs. 4.7 p = 0.04) and 60 minutes (2.6 vs. 3.6 p = 0.03).
CONCLUSIONS


This animal model of asphyxial CA shows that a respiratory rate of 30 rpm is more effective to reach normoventilation than 20 rpm in piglets after ROSC. This ventilation strategy seems to be safe, as it does not cause hyperventilation and does not affect hemodynamics or cerebral tissue perfusion.",2020,"Lactic acid levels were high immediately after ROSC in both groups, but were significantly lower in the 20 rpm group at 30 (3.7 vs. 4.7 p = 0.04) and 60 minutes (2.6 vs. 3.6 p = 0.03).
",['50 piglets under asphyxial CA'],['ventilation rate'],"['Arterial partial pressure of carbon dioxide (PaCO2', 'Lactic acid levels', 'pH normalization', 'Hemodynamic, perfusion and ventilation parameters']","[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}]","[{'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0428190', 'cui_str': 'Measurement of arterial partial pressure of carbon dioxide'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.046131,"Lactic acid levels were high immediately after ROSC in both groups, but were significantly lower in the 20 rpm group at 30 (3.7 vs. 4.7 p = 0.04) and 60 minutes (2.6 vs. 3.6 p = 0.03).
","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'López', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañón General University Hospital, Madrid, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Arias', 'Affiliation': 'School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Domenech', 'Affiliation': 'School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Horcajo', 'Affiliation': 'School of Medicine, Complutense University of Madrid, Madrid, Spain.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Nocete', 'Affiliation': 'Gregorio Marañón Health Research Institute, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Zamora', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañón General University Hospital, Madrid, Spain.'}, {'ForeName': 'Sarah Nicole', 'Initials': 'SN', 'LastName': 'Fernández', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañón General University Hospital, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'López-Herce', 'Affiliation': 'Pediatric Intensive Care Department, Gregorio Marañón General University Hospital, Madrid, Spain.'}]",PloS one,['10.1371/journal.pone.0237736']
2719,32817749,Effects of weight loss during a very low carbohydrate diet on specific adipose tissue depots and insulin sensitivity in older adults with obesity: a randomized clinical trial.,"Background


Insulin resistance and accumulation of visceral adipose tissue (VAT) and intermuscular adipose tissue (IMAT) place aging adults with obesity at high risk of cardio-metabolic disease. A very low carbohydrate diet (VLCD) may be a means of promoting fat loss from the visceral cavity and skeletal muscle, without compromising lean mass, and improve insulin sensitivity in aging adults with obesity.
Objective


To determine if a VLCD promotes a greater loss of fat (total, visceral and intermuscular), preserves lean mass, and improves insulin sensitivity compared to a standard CHO-based/low-fat diet (LFD) in older adults with obesity.
Design


Thirty-four men and women aged 60-75 years with obesity (body mass index [BMI] 30-40 kg/m 2 ) were randomized to a diet prescription of either a VLCD (< 10:25:> 65% energy from CHO:protein:fat) or LFD diet (55:25:20) for 8 weeks. Body composition by dual-energy X-ray absorptiometry (DXA), fat distribution by magnetic resonance imaging (MRI), insulin sensitivity by euglycemic hyperinsulinemic clamp, and lipids by a fasting blood draw were assessed at baseline and after the intervention.
Results


Participants lost an average of 9.7 and 2.0% in total fat following the VLCD and LFD, respectively ( p  < 0.01). The VLCD group experienced ~ 3-fold greater loss in VAT compared to the LFD group (- 22.8% vs - 1.0%,  p  < 0.001) and a greater decrease in thigh-IMAT (- 24.4% vs - 1.0%,  p  < 0.01). The VLCD group also had significantly greater thigh skeletal muscle (SM) at 8 weeks following adjustment for change in total fat mass. Finally, the VLCD had greater increases in insulin sensitivity and HDL-C and decreases in fasting insulin and triglycerides compared to the LFD group.
Conclusions


Weight loss resulting from consumption of a diet lower in CHO and higher in fat may be beneficial for older adults with obesity by depleting adipose tissue depots most strongly implicated in poor metabolic and functional outcomes and by improving insulin sensitivity and the lipid profile.
Trial registration


NCT02760641. Registered 03 May 2016 - Retrospectively registered.",2020,"Finally, the VLCD had greater increases in insulin sensitivity and HDL-C and decreases in fasting insulin and triglycerides compared to the LFD group.
","['Design\n\n\nThirty-four men and women aged 60-75\u2009years with obesity (body mass index [BMI] 30-40\u2009kg/m 2 ', 'adults with obesity at high risk of cardio-metabolic disease', 'older adults with obesity']","['standard CHO-based/low-fat diet (LFD', 'VLCD (<\u200910:25:>\u200965% energy from CHO:protein:fat) or LFD diet', 'VLCD', 'weight loss during a very low carbohydrate diet', 'LFD', 'low carbohydrate diet (VLCD']","['VAT', 'loss of fat (total, visceral and intermuscular), preserves lean mass, and improves insulin sensitivity', 'insulin sensitivity and HDL-C', 'thigh skeletal muscle (SM', 'Body composition by dual-energy X-ray absorptiometry (DXA), fat distribution by magnetic resonance imaging (MRI), insulin sensitivity by euglycemic hyperinsulinemic clamp, and lipids by a fasting blood draw', 'fasting insulin and triglycerides', 'thigh-IMAT']","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0025517', 'cui_str': 'Metabolic disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0301577', 'cui_str': 'Carbohydrate diet'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0259836', 'cui_str': 'Carbohydrate restricted diet'}]","[{'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}]",,0.0714266,"Finally, the VLCD had greater increases in insulin sensitivity and HDL-C and decreases in fasting insulin and triglycerides compared to the LFD group.
","[{'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Goss', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, 640 Webb Building, 1675 University Blvd, Birmingham, AL 35294-3360 USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gower', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, 640 Webb Building, 1675 University Blvd, Birmingham, AL 35294-3360 USA.'}, {'ForeName': 'Taraneh', 'Initials': 'T', 'LastName': 'Soleymani', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, 640 Webb Building, 1675 University Blvd, Birmingham, AL 35294-3360 USA.'}, {'ForeName': 'Mariah', 'Initials': 'M', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, 640 Webb Building, 1675 University Blvd, Birmingham, AL 35294-3360 USA.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Pendergrass', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, 640 Webb Building, 1675 University Blvd, Birmingham, AL 35294-3360 USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lockhart', 'Affiliation': 'Department of Medicine, Division of Radiology, University of Alabama at Birmingham, Birmingham, AL 35294 USA.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Krantz', 'Affiliation': 'Department of Health Behavior, University of Alabama at Birmingham, Birmingham, AL 35294 USA.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Dowla', 'Affiliation': 'Department of Health Behavior, University of Alabama at Birmingham, Birmingham, AL 35294 USA.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Bush', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, 640 Webb Building, 1675 University Blvd, Birmingham, AL 35294-3360 USA.'}, {'ForeName': 'Valene', 'Initials': 'V', 'LastName': 'Garr Barry', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, 640 Webb Building, 1675 University Blvd, Birmingham, AL 35294-3360 USA.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Fontaine', 'Affiliation': 'Department of Health Behavior, University of Alabama at Birmingham, Birmingham, AL 35294 USA.'}]",Nutrition & metabolism,['10.1186/s12986-020-00481-9']
2720,32817752,"A pilot randomized controlled trial to assess the effect of Islamic spiritual intervention and of breathing technique with heart rate variability feedback on anxiety, depression and psycho-physiologic coherence in patients after coronary artery bypass surgery.","Background


This study investigated the effects of Islamic religious and breathing techniques with heart rate variability (HRV) biofeedback therapies on HRV and psycho-physiologic coherence (resonance frequency), depression and anxiety in coronary artery bypass graft surgery (CABG) patients.
Methods


Sixty CABG patients were chosen and randomly assigned to religious, breathing techniques and control groups. The experimental groups received 8  weeks of treatments; a 2-h session with home works in each week. The control group received only their normal hospital interventions. The groups' depression, anxiety, HRV and psycho-physiologic coherence levels were assessed before and after the interventions by DASS-21 for depression and anxiety, and em-wave desktop software for HRV and psycho-physiologic coherence. The data were analyzed using ANCOVA with Bonferroni Comparison test and descriptive tests in SPSS software.
Results


The findings showed that there were significant differences in psycho-physiologic coherence (HRV), depression and anxiety scores among the three groups in the post-tests. In fact, depression and anxiety were reduced more in the religious group, while psycho-physiologic coherence raised more in the breathing with the HRV feedback group.
Conclusion


The results showed that both Islamic religious and breathing techniques with HRV biofeedback therapies can be used in rehabilitation programs for CABG patients in clinics and hospitals.",2020,The results showed that both Islamic religious and breathing techniques with HRV biofeedback therapies can be used in rehabilitation programs for CABG patients in clinics and hospitals.,"['patients after coronary artery bypass surgery', 'coronary artery bypass graft surgery (CABG) patients', 'CABG patients in clinics and hospitals', 'Methods\n\n\nSixty CABG patients']","['normal hospital interventions', 'Islamic religious and breathing techniques with heart rate variability (HRV) biofeedback therapies', 'Islamic spiritual intervention and of breathing technique with heart rate variability feedback']","['anxiety, depression and psycho-physiologic coherence', 'psycho-physiologic coherence (HRV), depression and anxiety scores', 'depression, anxiety, HRV and psycho-physiologic coherence levels', 'HRV and psycho-physiologic coherence (resonance frequency), depression and anxiety', 'depression and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0022126', 'cui_str': 'Islam'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231881', 'cui_str': 'Resonance'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",60.0,0.0297097,The results showed that both Islamic religious and breathing techniques with HRV biofeedback therapies can be used in rehabilitation programs for CABG patients in clinics and hospitals.,"[{'ForeName': 'Mohiadin', 'Initials': 'M', 'LastName': 'Amjadian', 'Affiliation': 'Clinical Psychology Department, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Bahrami Ehsan', 'Affiliation': 'Psychology Department, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Kaivan', 'Initials': 'K', 'LastName': 'Saboni', 'Affiliation': 'Surgery Department, Medical Sciences University of Kurdistan, Sanandaj, Iran.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Vahedi', 'Affiliation': 'Cardiology Department, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Rostami', 'Affiliation': 'Psychology Department, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Daem', 'Initials': 'D', 'LastName': 'Roshani', 'Affiliation': 'Social Determinants of Health Research Center, Research Institute for Health Development, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}]",Annals of general psychiatry,['10.1186/s12991-020-00296-1']
2721,32818264,"Pharmacokinetic and safety study of co-administration of albendazole, diethylcarbamazine, Ivermectin and azithromycin for the integrated treatment of Neglected Tropical Diseases.","BACKGROUND


Pharmacokinetic data are a pre-requisite to integrated implementation of large-scale mass drug administration (MDA) for neglected tropical diseases (NTDs). We investigated the safety and drug interactions of a combination of azithromycin (AZI) targeting yaws and trachoma, with the newly approved ivermectin, albendazole, diethylcarbamazine (IDA) regime for Lymphatic Filariasis.
METHODOLOGY


An open-label, randomized, 3-arm pharmacokinetic interaction study in adult volunteers was carried out in Lihir Island, Papua New Guinea. Healthy adult participants were recruited and randomized to (I) IDA alone, (II) IDA combined with AZI, (III) AZI alone. The primary outcome was lack of a clinically relevant drug interaction. The secondary outcome was the overall difference in the proportion of AEs between treatment arms.
RESULTS


Thirty-seven participants, eighteen men and nineteen women, were randomized and completed the study. There were no significant drug-drug interactions between the study arms. The GMR of Cmax, AUC0-t, and AUC0-∞ for IVM, DEC, ALB-SOX, and AZI were within the range of 80-125% (GMR for AUC0-∞ for IVM, 87.9; DEC, 92.9; ALB-SOX, 100.0; and AZI, 100.1). There was no significant difference in the frequency of AEs across study arms (AZI and IDA alone arms 9/12 (75%), co-administration arm 12/13 (92%); p = 0.44). All AEs were grade 1 and self-limiting.
CONCLUSIONS


Co-administration of AZI with IDA did not show evidence of significant drug-interactions. There were no serious AEs in any of the study arms. Our data support further evaluation of the safety of integrated MDA for NTDs.Clinical Trials Registration. NCT03664063.",2020,"There was no significant difference in the frequency of AEs across study arms (AZI and IDA alone arms 9/12 (75%), co-administration arm 12/13 (92%); p = 0.44).","['Healthy adult participants', 'adult volunteers was carried out in Lihir Island, Papua New Guinea', 'Thirty-seven participants, eighteen men and nineteen women', 'Neglected Tropical Diseases']","['IDA combined with AZI, (III) AZI alone', 'Co-administration of AZI', 'albendazole, diethylcarbamazine, Ivermectin and azithromycin', 'azithromycin (AZI', 'ivermectin, albendazole, diethylcarbamazine (IDA']","['GMR of Cmax, AUC0-t, and AUC0-∞ for IVM, DEC, ALB-SOX, and AZI', 'lack of a clinically relevant drug interaction', 'proportion of AEs', 'frequency of AEs', 'drug-drug interactions']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0022130', 'cui_str': 'Island'}, {'cui': 'C0030375', 'cui_str': 'Papua New Guinea'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0001911', 'cui_str': 'Albendazole'}, {'cui': 'C0012191', 'cui_str': 'Diethylcarbamazine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C1522544', 'cui_str': 'CSF2RA protein, human'}, {'cui': 'C0596795', 'cui_str': 'In Vivo Microscopy'}, {'cui': 'C0001909', 'cui_str': 'Albania'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0678798', 'cui_str': 'Adverse drug interaction'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0687133', 'cui_str': 'Drug interaction with drug'}]",,0.210524,"There was no significant difference in the frequency of AEs across study arms (AZI and IDA alone arms 9/12 (75%), co-administration arm 12/13 (92%); p = 0.44).","[{'ForeName': 'Lucy N', 'Initials': 'LN', 'LastName': 'John', 'Affiliation': 'National Department of Health, Port Moresby, Papua New Guinea.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Bjerum', 'Affiliation': 'Case Western Reserve University School of Medicine and Veterans Affairs Medical Center, Cleveland, OH, United States.'}, {'ForeName': 'Pere Millat', 'Initials': 'PM', 'LastName': 'Martinez', 'Affiliation': 'Lihir Malaria Elimination Program, Newcrest Lihir, New Ireland Province, Papua New Guinea.'}, {'ForeName': 'Rhoda', 'Initials': 'R', 'LastName': 'Likia', 'Affiliation': 'Lihir Malaria Elimination Program, Newcrest Lihir, New Ireland Province, Papua New Guinea.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Silus', 'Affiliation': 'Lihir Malaria Elimination Program, Newcrest Lihir, New Ireland Province, Papua New Guinea.'}, {'ForeName': 'Chilaka', 'Initials': 'C', 'LastName': 'Wali', 'Affiliation': 'Barcelona Institute for Global Health - University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Elizah', 'Affiliation': 'Lihir Malaria Elimination Program, Newcrest Lihir, New Ireland Province, Papua New Guinea.'}, {'ForeName': 'Yashpal S', 'Initials': 'YS', 'LastName': 'Chhonker', 'Affiliation': 'Clinical Pharmacology Laboratory, Dept. of Pharmacy Practice and Science, Nebraska University Medical Center, Omaha, NE, United States.'}, {'ForeName': 'Veenu', 'Initials': 'V', 'LastName': 'Bala', 'Affiliation': 'Clinical Pharmacology Laboratory, Dept. of Pharmacy Practice and Science, Nebraska University Medical Center, Omaha, NE, United States.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'King', 'Affiliation': 'Case Western Reserve University School of Medicine and Veterans Affairs Medical Center, Cleveland, OH, United States.'}, {'ForeName': 'Daryl J', 'Initials': 'DJ', 'LastName': 'Murry', 'Affiliation': 'Clinical Pharmacology Laboratory, Dept. of Pharmacy Practice and Science, Nebraska University Medical Center, Omaha, NE, United States.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'Mitja', 'Affiliation': 'Barcelona Institute for Global Health - University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marks', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciaa1202']
2722,32818267,Feasibility of using deep learning to detect coronary artery disease based on facial photo.,"AIMS


Facial features were associated with increased risk of coronary artery disease (CAD). We developed and validated a deep learning algorithm for detecting CAD based on facial photos.
METHODS AND RESULTS


We conducted a multicentre cross-sectional study of patients undergoing coronary angiography or computed tomography angiography at nine Chinese sites to train and validate a deep convolutional neural network for the detection of CAD (at least one ≥50% stenosis) from patient facial photos. Between July 2017 and March 2019, 5796 patients from eight sites were consecutively enrolled and randomly divided into training (90%, n = 5216) and validation (10%, n = 580) groups for algorithm development. Between April 2019 and July 2019, 1013 patients from nine sites were enrolled in test group for algorithm test. Sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) were calculated using radiologist diagnosis as the reference standard. Using an operating cut point with high sensitivity, the CAD detection algorithm had sensitivity of 0.80 and specificity of 0.54 in the test group; the AUC was 0.730 (95% confidence interval, 0.699-0.761). The AUC for the algorithm was higher than that for the Diamond-Forrester model (0.730 vs. 0.623, P < 0.001) and the CAD consortium clinical score (0.730 vs. 0.652, P < 0.001).
CONCLUSION


Our results suggested that a deep learning algorithm based on facial photos can assist in CAD detection in this Chinese cohort. This technique may hold promise for pre-test CAD probability assessment in outpatient clinics or CAD screening in community. Further studies to develop a clinical available tool are warranted.",2020,"Using an operating cut point with high sensitivity, the CAD detection algorithm had sensitivity of 0.80 and specificity of 0.54 in the test group; the AUC was 0.730","['patients undergoing coronary angiography or computed tomography angiography at nine Chinese sites to train and validate a deep convolutional neural network for the detection of CAD (at least one ≥50% stenosis) from patient facial photos', 'Between July 2017 and March 2019, 5796 patients from eight sites', 'outpatient clinics or CAD screening in community', 'Between April 2019 and July 2019, 1013 patients from nine sites were enrolled in test group for algorithm test']",['deep learning'],"['CAD consortium clinical score', 'Sensitivity, specificity, and area under the receiver operating characteristic curve (AUC', 'risk of coronary artery disease (CAD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}]","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",5796.0,0.0412078,"Using an operating cut point with high sensitivity, the CAD detection algorithm had sensitivity of 0.80 and specificity of 0.54 in the test group; the AUC was 0.730","[{'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing 100037, People's Republic of China.""}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Automation, Tsinghua University, Main building, Haidian District, Beijing 100084, People's Republic of China.""}, {'ForeName': 'Bowen', 'Initials': 'B', 'LastName': 'Fu', 'Affiliation': ""Department of Automation, Tsinghua University, Main building, Haidian District, Beijing 100084, People's Republic of China.""}, {'ForeName': 'Sipeng', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': ""Department of Information Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing 100037, People's Republic of China.""}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing 100037, People's Republic of China.""}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Medical Research & Biometrics Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing 100037, People's Republic of China.""}, {'ForeName': 'Xiaoyi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing 100037, People's Republic of China.""}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Lv', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing 100037, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing 100037, People's Republic of China.""}, {'ForeName': 'Xiantao', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ""Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, No. 2 Anzhen Road, Chaoyang District, Beijing 100029, People's Republic of China.""}, {'ForeName': 'Yao-Jun', 'Initials': 'YJ', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, Xuzhou Third People's Hospital, Xuzhou Medical University, No. 131 Huancheng Road, Huaihai Economy District, Xuzhou 221000, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Cheng', 'Affiliation': ""Department of Cardiology, Wuhan Union Hospital, No. 1277 Jiefang Avenue, Jianghan District, Wuhan 430022, Hubei, People's Republic of China.""}, {'ForeName': 'Weijian', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Cardiology, The First Affiliated Hospital of Wenzhou Medical University, Nanbaixiang Road, Ouhai District, Wenzhou 325000, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Pu', 'Affiliation': ""Department of Cardiology, RenJi Hospital, Shanghai JiaoTong University Medical College, No. 160 Pujian Road, Pudong New District, Shanghai 200120, People's Republic of China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': ""Department of Cardiology, Shanghai East Hospital, Tongji University School of Medicine, No. 150 Jimo Road, Pudong New District, Shanghai 200120, People's Republic of China.""}, {'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': ""Department of Cardiology, The First Affiliated Hospital of Dalian Medical University, No. 222 Zhongshan Road, Xigang District, Dalian 116011, People's Republic of China.""}, {'ForeName': 'Bai', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': ""Department of Cardiology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No.5 Beixiange Road, Xicheng District, Beijing 100053, People's Republic of China.""}, {'ForeName': 'Xiangyang', 'Initials': 'X', 'LastName': 'Ji', 'Affiliation': ""Department of Automation, Tsinghua University, Main building, Haidian District, Beijing 100084, People's Republic of China.""}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': ""National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 167 Beilishi Road, Xicheng District, Beijing 100037, People's Republic of China.""}]",European heart journal,['10.1093/eurheartj/ehaa640']
2723,32818325,Randomized Trial of Cognitive Behavior Group Therapy and a Mindfulness-based Intervention for Social Anxiety Disorder: Preliminary Findings.,"Recent studies have evaluated the possible efficacy of mindfulness-based interventions (MBIs) for social anxiety disorder (SAD). However, few trials have compared MBIs to a first-line treatment. This study evaluated the relative efficacy of a MBI adapted for SAD (MBI-SAD) to cognitive behavior group therapy (CBGT) for SAD. Participants were randomized to 12-weekly group sessions of the MBI-SAD (n=52) or CBGT (n=45). Results revealed that CBGT fared better than the MBI-SAD in reducing clinician- and self-rated social anxiety severity. The difference between the MBI-SAD and CBGT exceeded the pre-specified non-inferiority margin for our primary outcome the Liebowtiz Social Anxiety Scale, but findings are inconclusive as the width of the confidence interval extended in both directions surrounding the non-inferiority margin. The MBI-SAD compared favorably to CBGT in improving other indices of well-being (depression, self-esteem, satisfaction with life, social adjustment). Contrary to expectation, the MBI-SAD did not produce greater changes in mindfulness and self-compassion than CBGT. Overall, results confirm that CBGT is robust treatment for SAD and should be considered as first-line treatment.",2020,Results revealed that CBGT fared better than the MBI-SAD in reducing clinician- and self-rated social anxiety severity.,['Social Anxiety Disorder'],"['MBI-SAD (n=52) or CBGT', 'Cognitive Behavior Group Therapy and a Mindfulness-based Intervention', 'CBGT', 'MBI adapted for SAD (MBI-SAD) to cognitive behavior group therapy (CBGT', 'MBI-SAD', 'mindfulness-based interventions (MBIs']","['MBI-SAD and CBGT', 'Liebowtiz Social Anxiety Scale', 'clinician- and self-rated social anxiety severity', 'mindfulness and self-compassion', 'indices of well-being (depression, self-esteem, satisfaction with life, social adjustment']","[{'cui': 'C0031572', 'cui_str': 'Social phobia'}]","[{'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2985547', 'cui_str': 'Scintimammography'}, {'cui': 'C0031572', 'cui_str': 'Social phobia'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}]",,0.0215358,Results revealed that CBGT fared better than the MBI-SAD in reducing clinician- and self-rated social anxiety severity.,"[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Koszycki', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Guérin', 'Affiliation': 'Institut du Savoir Montfort, Ottawa, Ontario, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'DiMillo', 'Affiliation': 'Institut du Savoir Montfort, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Bradwejn', 'Affiliation': 'University of Ottawa, Ottawa, Ontario, Canada.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2502']
2724,32818328,"Intraindividual comparison of cytokine and prostaglandin levels with and without low-energy, high-frequency femtosecond laser cataract pretreatment after single-dose topical NSAID application.","PURPOSE


To investigate interleukin (IL)-1β, IL-6, and total prostaglandin (PG) levels in the anterior chamber in patients undergoing low pulse energy femtosecond laser-assisted cataract surgery.
METHODS


Forty patients undergoing immediate sequential cataract surgery received randomized low-energy femtosecond laser pretreatment in 1 eye and conventional phacoemulsification in the other. Aqueous humor was collected precisely 5 minutes after femtosecond laser pretreatment and before conventional phacoemulsification from all 80 eyes. IL-1β, IL-6, and total PG (including PGE1, PGE2; PGF1a, PGF2a) levels were analyzed using enzyme-linked immunoassay kits. One drop of ketorolac 0.5% was administered 30 minutes preoperatively.
RESULTS


Mean concentrations of IL-1β, IL-6, and total PG were 0.87, 0.67, and 32.19 pg/mL in the femto group compared with 0.10 (P = .36), 0.78 (P = .79), and 19.66 pg/mL (P < .05) in the nonfemto group. Levels of IL-1β and IL-6 were not statistically significantly different when compared between groups. There was a small but statistically significant increase of PG levels in the femto group. There were no statistically significant correlations between levels of 1β, IL-6, or total PG and suction time or lens density (P > .05).
CONCLUSIONS


Low pulse energy femtosecond laser pretreatment did not trigger any additional IL and only a small but statistically significant increase of PG release in the anterior chamber after a single-dose of topical nonsteroidal antiinflammatory drug administered 30 minutes before the start of cataract surgery. The findings indicated that the minor inflammatory reaction was due to the lower pulse energy concept applied by the femtosecond laser.",2020,"Mean concentrations of IL-1β, IL-6, and total PG were 0.87, 0.67, and 32.19 pg/mL in the femto group compared with 0.10 (P = .36), 0.78","['patients undergoing', 'Forty patients undergoing immediate sequential cataract surgery received']","['cytokine and prostaglandin levels with and without low-energy, high-frequency femtosecond laser cataract', 'low pulse energy femtosecond laser-assisted cataract surgery', 'ketorolac', 'randomized low-energy femtosecond laser pretreatment in 1 eye and conventional phacoemulsification', 'femtosecond laser pretreatment and before conventional phacoemulsification']","['levels of 1β, IL-6, or total PG and suction time or lens density', 'Mean concentrations of IL-1β, IL-6, and total PG', 'Levels of IL-1β and IL-6', 'PG release', 'PG levels', 'interleukin (IL)-1β, IL-6, and total prostaglandin (PG) levels', 'IL-1β, IL-6, and total PG (including PGE1, PGE2; PGF1a, PGF2a) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C1266240', 'cui_str': 'Prostaglandin measurement'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C1531960', 'cui_str': 'Femtosecond pulsed laser device'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0033554', 'cui_str': 'Prostaglandin'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C1266240', 'cui_str': 'Prostaglandin measurement'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002335', 'cui_str': 'Alprostadil'}, {'cui': 'C0012472', 'cui_str': 'Dinoprostone'}, {'cui': 'C0012471', 'cui_str': 'Dinoprost'}]",40.0,0.0724059,"Mean concentrations of IL-1β, IL-6, and total PG were 0.87, 0.67, and 32.19 pg/mL in the femto group compared with 0.10 (P = .36), 0.78","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'From the Department of Ophthalmology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': ''}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': ''}]",Journal of cataract and refractive surgery,['10.1097/j.jcrs.0000000000000221']
2725,32818720,A Pilot Mind-Body Resiliency Intervention Targeting Fear of Recurrence among Cancer Survivors.,"OBJECTIVE


Interventions for fear of recurrence (FOR) of cancer have nominal effects, perhaps due to limited integration of empirically supported skills. This pilot trial tested the acceptability and feasibility of a multimodal, mind-body resiliency intervention targeting FOR among survivors of various cancers.
METHODS


Early stage cancer survivors 330 months post-treatment were recruited to participate in an eight-session in-person mind-body resiliency group intervention that taught relaxation skills, cognitive-behavioral techniques, healthy lifestyle behaviors, mindfulness meditation, and positive psychology skills all targeted for FOR. Primary outcomes were feasibility (enrollment rate, session attendance, survey completion, skills practice) and acceptability (enjoyableness, convenience, helpfulness, relevance). Patient-reported outcomes (FOR, uncertainty intolerance, cancer-related uncertainty, perceived stress, resiliency, positive affect, and coping skills) were collected at baseline, post-intervention, +1 month, and +3 months. Exit interviews assessed survivors' reported benefits.
RESULTS


Participants (N = 4 groups, 23 survivors, enrollment response rate = 58%) included survivors of seven common cancer types who were on average 12 months post-treatment. Attendance was high (M = 6.1 sessions), and 96% of survivors completed all surveys. Sustained increases in relaxation skills practice 3+ days/week were reported (baseline = 16%, post-intervention = 76%, +3 months = 71%). Most sessions (87%) were rated as highly or very highly acceptable. Moderate-to-large (d = 0.87) improvements in FOR severity were observed post-intervention (p < .01) and across assessments (p < .01), with similar changes observed in other patient-reported outcomes. Exit interviews revealed behavioral, cognitive, emotional, and existential benefits.
CONCLUSIONS


The targeted mind-body resiliency intervention shows promising acceptability, feasibility, and favorable changes in FOR and coping skills practice. Further adaptation and testing in a randomized trial are warranted. ClinicalTrials.govRegistration Number: NCT03695406.",2020,"Moderate-to-large (d = 0.87) improvements in FOR severity were observed post-intervention (p < .01) and across assessments (p < .01), with similar changes observed in other patient-reported outcomes.","['survivors of various cancers', 'Cancer Survivors', 'Early stage cancer survivors 330\xa0months post-treatment were recruited to participate in an eight']","['multimodal, mind-body resiliency intervention', 'session in-person mind-body resiliency group intervention that taught relaxation skills, cognitive-behavioral techniques, healthy lifestyle behaviors, mindfulness meditation, and positive psychology skills all targeted for FOR']","['FOR, uncertainty intolerance, cancer-related uncertainty, perceived stress, resiliency, positive affect, and coping skills', 'behavioral, cognitive, emotional, and existential benefits', 'feasibility (enrollment rate, session attendance, survey completion, skills practice) and acceptability (enjoyableness, convenience, helpfulness, relevance', 'FOR severity', 'relaxation skills practice']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C4517719', 'cui_str': '330'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1510628', 'cui_str': 'Positive Psychology'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0086059', 'cui_str': 'Coping Skills'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}]",,0.129392,"Moderate-to-large (d = 0.87) improvements in FOR severity were observed post-intervention (p < .01) and across assessments (p < .01), with similar changes observed in other patient-reported outcomes.","[{'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Hall', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, United States of America. Electronic address: hall@mgh.harvard.edu.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Massachusetts General Hospital/Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Cheung', 'Affiliation': 'Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Davis', 'Affiliation': 'Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, United States of America.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110215']
2726,32818931,Early Treatment with Human Albumin Solution in Continuous Renal Replacement Patients.,"AIMS


To study the impact of early human albumin solution (HAS) in continuous renal replacement therapy (RRT) patients.
METHODS


Analysis of Randomized Evaluation of Normal versus Augmented Level (RENAL) RRT trial data.
RESULTS


Of 1,464 patients, 500 (34%) received early albumin. These patients had higher illness severity scores, greater use of mechanical ventilation, and 90-day mortality (51 vs. 41%; p < 0.001). However, early albumin carried similar RRT dependence risk among survivors at day 90 (4.9 vs. 5.8%; p = 0.62). On Cox proportional hazards regression, with standardized inverse probability of treatment weighting, early albumin was not associated with increased mortality (hazard ratio [HR]: 1.23, 95% CI: 0.97-1.55; p = 0.09) or recovery to RRT independence (HR: 0.92, 95% CI: 0.78-1.10; p = 0.38).
CONCLUSIONS


Early albumin was administered to one-third of RENAL trial patients and in those with greater illness severity. Early albumin was not independently associated with mortality risk or rate of recovery to RRT independence.",2020,"These patients had higher illness severity scores, greater use of mechanical ventilation, and 90-day mortality (51 vs. 41%; p < 0.001).","['continuous renal replacement therapy (RRT) patients', 'Continuous Renal Replacement Patients', 'Of 1,464 patients, 500 (34%) received early albumin']","['early human albumin solution (HAS', 'Human Albumin Solution', 'Normal versus Augmented Level (RENAL']","['recovery to RRT independence', 'mortality', 'illness severity scores, greater use of mechanical ventilation, and 90-day mortality', 'mortality risk or rate of recovery to RRT independence']","[{'cui': 'C3649547', 'cui_str': 'Continuous renal replacement therapy'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1302112', 'cui_str': 'Renal replacement'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0001924', 'cui_str': 'albumin'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0359180', 'cui_str': 'Albumin solution'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]","[{'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",1464.0,0.230725,"These patients had higher illness severity scores, greater use of mechanical ventilation, and 90-day mortality (51 vs. 41%; p < 0.001).","[{'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Intensive Care, Austin Hospital, Heidelberg, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Finnis', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gallagher', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'Department of Intensive Care, Austin Hospital, Heidelberg, Melbourne, Victoria, Australia, rinaldo.bellomo@austin.org.au.'}]",Blood purification,['10.1159/000509890']
2727,32818946,Greater Attendance at a Community Weight Loss Programme over the First 12 Weeks Predicts Weight Loss at 2 Years.,"BACKGROUND


There is considerable heterogeneity in long-term weight loss among people referred to obesity treatment programmes. It is unclear whether attendance at face-to-face sessions in the early weeks of the programme is an independent predictor of long-term success.
OBJECTIVE


To investigate whether frequency of attendance at a community weight loss programme over the first 12 weeks is associated with long-term weight change.
METHODS


Participants were randomised to receive brief support only (control, n = 211), or a weight loss programme for 12 weeks (n = 530) or 52 weeks (n = 528). This study included participants with data on session attendance over the first 12 weeks (n = 889) compared to the control group. The association between attendance (continuously) and weight loss was explored using a linear model. A multi-level mixed-effects linear model was used to investigate whether attendance (categorised as 0, 1, 2-5, 6-9, and 10-12 sessions) was associated with weight loss at 3, 12, and 24 months compared to the control.
RESULTS


For every session attended in the first 12 weeks, the average weight loss was -0.259 kg/session at 24 months (p = 0.005). Analysis by attendance group found only those attending 10-12 sessions had significantly greater weight loss (-7.5 kg [95% CI -8.1 to -6.9] at 12 months; -4.7 kg [95% CI -5.3 to -4.1] at 24 months) compared to the control group (-3.4 [95% CI -4.5 to -2.4] at 12 months, -2.5 [95% CI -3.5 to -1.5] at 24 months). Early attendance was higher for people ≥70 years, but there was no evidence of a difference by gender, ethnicity, education, or income.
CONCLUSIONS


Greater attendance at a community weight loss programme in the first 12 weeks is associated with enhanced weight loss up to 24 months. Regular attendance at a programme could be used as a criterion for continued provision of weight loss services to maximise the cost-effectiveness of interventions.",2020,"Early attendance was higher for people ≥70 years, but there was no evidence of a difference by gender, ethnicity, education, or income.
","['Participants', 'participants with data on session attendance over the first 12 weeks (n = 889', 'people referred to obesity treatment programmes']",['weight loss programme'],"['weight loss', 'enhanced weight loss', 'attendance (continuously) and weight loss', 'average weight loss']","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C4706528', 'cui_str': 'Obesity care'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",,0.0377466,"Early attendance was higher for people ≥70 years, but there was no evidence of a difference by gender, ethnicity, education, or income.
","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Piernas', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom, carmen.piernas-sanchez@phc.ox.ac.uk.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'MacLean', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Ahern', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Woolston', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Boyland', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Jason C G', 'Initials': 'JCG', 'LastName': 'Halford', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom.'}]",Obesity facts,['10.1159/000509131']
2728,32818949,Antenatal N-acetylcysteine to improve outcomes of premature infants with intra-amniotic infection and inflammation (Triple I): randomized clinical trial.,"BACKGROUND


Intrauterine infection and/or inflammation (Triple I) is an important cause of preterm birth (PTB) and adverse newborn outcomes. N-acetylcysteine (NAC) is a Food and Drug Administration (FDA)-approved drug safely administered to pregnant women with acetaminophen toxicity.
METHODS


We conducted a single-center, quadruple-blind, placebo-controlled trial of pregnant women with impending PTB due to confirmed Triple I. Participants (n = 67) were randomized to an intravenous infusion of NAC or placebo mimicking the FDA-approved regimen. Outcomes included clinical measures and mechanistic biomarkers.
RESULTS


Newborns exposed to NAC (n = 33) had significantly improved status at birth and required less intensive resuscitation compared to placebo (n = 34). Fewer NAC-exposed newborns developed two or more prematurity-related severe morbidities [NAC: 21% vs. placebo: 47%, relative risk, 0.45; 95% confidence interval (CI) 0.21-0.95] with the strongest protection afforded against bronchopulmonary dysplasia (BPD, NAC: 3% vs. placebo: 32%, relative risk, 0.10; 95% CI: 0.01-0.73). These effects were independent of gestational age, birth weight, sex, or race. Umbilical cord plasma NAC concentration correlated directly with cysteine, but not with plasma or whole blood glutathione. NAC reduced the placental expression of histone deacetylase-2, suggesting that epigenetic mechanisms may be involved.
CONCLUSIONS


These data provide support for larger studies of intrapartum NAC to reduce prematurity-related morbidity.
IMPACT


In this randomized clinical trial of 65 women and their infants, maternal intravenous NAC employing the FDA-approved dosing protocol resulted in lower composite neonatal morbidity independent of gestational age, race, sex, and birthweight. Administration of NAC in amniocentesis-confirmed Triple I resulted in a remarkably lower incidence of BPD. As prior studies have not shown a benefit of postnatal NAC in ventilated infants, our trial highlights the critical antenatal timing of NAC administration. Repurposing of NAC for intrapartum administration should be explored in larger clinical trials as a strategy to improve prematurity-related outcomes and decrease the incidence of BPD. Fig. 1 FLOWCHART OF ELIGIBLE PARTICIPANTS WITH INCLUSION AND EXCLUSION CIRCUMSTANCES.: PTL preterm labor, PPROM preterm prelabor rupture of membranes, r/o rule-out, GA gestational age, NAC N-acetylcysteine. *Thirteen patients who were ineligible for the trial based on negative assessment for Triple I contributed placental samples as reference for immunohistochemistry experiments. Fig. 2 IMMUNOHISTOCHEMISTRY OF PLACENTAL VILLOUS TISSUE FOR HISTONE DEACETYLASE-2.: Representative micrographs of immunohistochemical staining for histone deacetylase-2 (HDAC2) in placental villous tissue from women with idiopathic preterm birth (iPTB, a, b) absent Triple I or PTB in the context of Triple I who were enrolled in the trial and received either placebo (c, d) or N-acetylcysteine infusion (e, f). Vector NovaRed was used as peroxidase substrate and tissues were imaged and scored blindly for staining intensity without counterstaining. Negative slides (g) were exposed to nonimmune serum. Higher magnification inserts are shown in each lower right corner. All tissues available from the subjects in the trial were analyzed (NAC: n = 32; placebo: n = 33). **P < 0.01; ***p < 0.001. The cases presented in a, c, e, and g were delivered at 28 weeks of gestation. The cases illustrated in b, d, and f were delivered at 32 weeks of gestation. The scale bar (50 μm) denotes the magnification for the panels, which were photographed at ×200. Insets were imaged at ×600 magnification.",2020,"RESULTS


Newborns exposed to NAC (n = 33) had significantly improved status at birth and required less intensive resuscitation compared to placebo (n = 34).","['premature infants with intra-amniotic infection and inflammation (Triple I', '65 women and their infants, maternal intravenous NAC employing the FDA-approved dosing protocol resulted in lower composite neonatal morbidity independent of gestational age, race, sex, and birthweight', 'pregnant women with impending PTB due to confirmed Triple I. Participants (n\u2009=\u200967', 'women with idiopathic preterm birth (iPTB, a, b) absent', 'Thirteen patients who were ineligible for the trial based on negative assessment for Triple I contributed placental samples as reference for immunohistochemistry experiments', 'pregnant women with acetaminophen toxicity']","['NAC or placebo', 'Antenatal N-acetylcysteine', 'N-acetylcysteine (NAC', 'placebo (c, d) or N-acetylcysteine infusion (e, f', 'Triple I or PTB', 'NAC', 'immunohistochemical staining for histone deacetylase-2 (HDAC2', 'placebo']","['status at birth and required less intensive resuscitation', 'Umbilical cord plasma NAC concentration', 'BPD', 'clinical measures and mechanistic biomarkers', 'placental expression of histone deacetylase-2', 'prematurity-related severe morbidities']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332294', 'cui_str': 'Resulting in'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0237963', 'cui_str': 'Poisoning caused by acetaminophen'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0487602', 'cui_str': 'Staining method'}, {'cui': 'C0768528', 'cui_str': 'HDAC2 Histone Deacetylase'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0404413', 'cui_str': 'Placental expression'}, {'cui': 'C0768528', 'cui_str': 'HDAC2 Histone Deacetylase'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",65.0,0.55222,"RESULTS


Newborns exposed to NAC (n = 33) had significantly improved status at birth and required less intensive resuscitation compared to placebo (n = 34).","[{'ForeName': 'Catalin S', 'Initials': 'CS', 'LastName': 'Buhimschi', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA. csb01@uic.edu.'}, {'ForeName': 'Mert Ozan', 'Initials': 'MO', 'LastName': 'Bahtiyar', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Guomao', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, 43215, USA.""}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Abdelghany', 'Affiliation': 'Clinical Department of Pharmacy, Yale New Haven Hospital, New Haven, CT, 06510, USA.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Schneider', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, 43215, USA.""}, {'ForeName': 'Sonya Abdel', 'Initials': 'SA', 'LastName': 'Razeq', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Antonette T', 'Initials': 'AT', 'LastName': 'Dulay', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Heather S', 'Initials': 'HS', 'LastName': 'Lipkind', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Saya', 'Initials': 'S', 'LastName': 'Mieth', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, 43215, USA.""}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Rogers', 'Affiliation': ""Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, 43215, USA.""}, {'ForeName': 'Vineet', 'Initials': 'V', 'LastName': 'Bhandari', 'Affiliation': 'Department of Pediatrics, Yale University School of Medicine, New Haven, CT, 06510, USA.'}, {'ForeName': 'Irina A', 'Initials': 'IA', 'LastName': 'Buhimschi', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, New Haven, CT, 06510, USA.'}]",Pediatric research,['10.1038/s41390-020-01106-w']
2729,32818953,Navigation aid for blind persons by visual-to-auditory sensory substitution: A pilot study.,"PURPOSE


In this study, we investigate to what degree augmented reality technology can be used to create and evaluate a visual-to-auditory sensory substitution device to improve the performance of blind persons in navigation and recognition tasks.
METHODS


A sensory substitution algorithm that translates 3D visual information into audio feedback was designed. This algorithm was integrated in an augmented reality based mobile phone application. Using the mobile device as sensory substitution device, a study with blind participants (n = 7) was performed. The participants navigated through pseudo-randomized obstacle courses using either the sensory substitution device, a white cane or a combination of both. In a second task, virtual 3D objects and structures had to be identified by the participants using the same sensory substitution device.
RESULTS


The realized application for mobile devices enabled participants to complete the navigation and object recognition tasks in an experimental environment already within the first trials without previous training. This demonstrates the general feasibility and low entry barrier of the designed sensory substitution algorithm. In direct comparison to the white cane, within the study duration of ten hours the sensory substitution device did not offer a statistically significant improvement in navigation.",2020,"In direct comparison to the white cane, within the study duration of ten hours the sensory substitution device did not offer a statistically significant improvement in navigation.",[],"['visual-to-auditory sensory substitution', 'sensory substitution device, a white cane or a combination of both']",['navigation'],[],"[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006856', 'cui_str': 'Cane'}]",[],,0.0374328,"In direct comparison to the white cane, within the study duration of ten hours the sensory substitution device did not offer a statistically significant improvement in navigation.","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Neugebauer', 'Affiliation': 'ZEISS Vision Science Lab, Eberhard-Karls-University Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Rifai', 'Affiliation': 'ZEISS Vision Science Lab, Eberhard-Karls-University Tuebingen, Tübingen, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Getzlaff', 'Affiliation': 'Institute for Applied Physics, Heinrich-Heine University Duesseldorf, Duesseldorf, Germany.'}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Wahl', 'Affiliation': 'ZEISS Vision Science Lab, Eberhard-Karls-University Tuebingen, Tübingen, Germany.'}]",PloS one,['10.1371/journal.pone.0237344']
2730,32776430,"Absorption, Pharmacokinetics, and Urinary Excretion of Pyridines After Consumption of Coffee and Cocoa-Based Products Containing Coffee in a Repeated Dose, Crossover Human Intervention Study.","SCOPE


The present study assesses the absorption, pharmacokinetics, and urinary excretion of coffee pyridines and their metabolites after daily regular exposure to specific dosages of coffee or cocoa-based products containing coffee (CBPCC), considering different patterns of consumption.
METHODS AND RESULTS


In a three-arm, crossover, randomized trial, 21 volunteers are requested to randomly consume for 1 month: one cup of espresso coffee per day, three cups of espresso coffee per day, or one cup of espresso coffee plus two CBPCC twice per day. The last day of the one-month treatment, blood and urine samples are collected for 24 h. Trigonelline, N-methylpyridinium, N-methylnicotinamide, and N-methyl-4-pyridone-5-carboxamide are quantified. Trigonelline and N-methylpyridinium absorption curves and 24-h urinary excretion reflect the daily consumption of different servings of coffee or CBPCC, showing also significant differences in main pharmacokinetic parameters. Moreover, inter-subject variability due to sex and smoking is assessed, showing sex-related differences in the metabolism of trigonelline and smoking-related ones for N-methylpyridinium.
CONCLUSION


The daily exposure to coffee pyridines after consumption of different coffee dosages in a real-life setting is established. This data will be useful for future studies aiming at evaluating the bioactivity of coffee-derived circulating metabolites in cell experiments, mimicking more realistic experimental conditions.",2020,"Trigonelline and N-methylpyridinium absorption curves and 24-h urinary excretion reflect the daily consumption of different servings of coffee or CBPCC, showing also significant differences in main pharmacokinetic parameters.",['21 volunteers are requested to randomly consume for 1 month: one'],"['Coffee and Cocoa-Based Products', 'cup of espresso coffee per day, three cups of espresso coffee per day, or one cup of espresso coffee plus two CBPCC', 'coffee or cocoa-based products containing coffee (CBPCC', 'Trigonelline']","['Absorption, Pharmacokinetics, and Urinary Excretion of Pyridines', 'absorption, pharmacokinetics, and urinary excretion of coffee pyridines and their metabolites']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0360301', 'cui_str': 'Product base'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0077132', 'cui_str': 'trigonelline'}]","[{'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0034251', 'cui_str': 'Pyridine'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",21.0,0.0279235,"Trigonelline and N-methylpyridinium absorption curves and 24-h urinary excretion reflect the daily consumption of different servings of coffee or CBPCC, showing also significant differences in main pharmacokinetic parameters.","[{'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Bresciani', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Science, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tassotti', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Science, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Rosi', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drug, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Martini', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Science, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Antonini', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Medicine and Surgery, University of Parma, Via Gramsci 14, Parma, 43126, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Dei Cas', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Medicine and Surgery, University of Parma, Via Gramsci 14, Parma, 43126, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Bonadonna', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases, Department of Medicine and Surgery, University of Parma, Via Gramsci 14, Parma, 43126, Italy.'}, {'ForeName': 'Furio', 'Initials': 'F', 'LastName': 'Brighenti', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drug, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Del Rio', 'Affiliation': 'Human Nutrition Unit, Department of Veterinary Science, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Mena', 'Affiliation': 'Human Nutrition Unit, Department of Food and Drug, University of Parma, Via Volturno 39, Parma, 43125, Italy.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000489']
2731,30934155,Determinants of fractional exhaled nitric oxide in healthy men and women from the European Community Respiratory Health Survey III.,"INTRODUCTION


The fractional exhaled nitric oxide (F E  NO) is a marker for type 2 inflammation used in diagnostics and management of asthma. In order to use F E  NO as a reliable biomarker, it is important to investigate factors that influence F E  NO in healthy individuals. Men have higher levels of F E  NO than women, but it is unclear whether determinants of F E  NO differ by sex.
OBJECTIVE


To identify determinants of F E  NO in men and women without lung diseases.
METHOD


Fractional exhaled nitric oxide was validly measured in 3881 healthy subjects that had answered the main questionnaire of the European Community Respiratory Health Survey III without airways or lung disease.
RESULTS


Exhaled NO levels were 21.3% higher in men compared with women P < 0.001. Being in the upper age quartile (60.3-67.6 years), men had 19.2 ppb (95% CI: 18.3, 20.2) higher F E  NO than subjects in the lowest age quartile (39.7-48.3 years) P = 0.02. Women in the two highest age quartiles (54.6-60.2 and 60.3-67.6 years) had 15.4 ppb (14.7, 16.2), P = 0.03 and 16.4 ppb (15.6, 17.1), P = <0.001 higher F E  NO, compared with the lowest age quartile. Height was related to 8% higher F E  NO level in men (P < 0.001) and 5% higher F E  NO levels in women (P = 0.008). Men who smoked had 37% lower F E  NO levels and women had 30% lower levels compared with never-smokers (P < 0.001 for both). Men and women sensitized to both grass and perennial allergens had higher F E  NO levels compared with non-sensitized subjects 26% and 29%, P < 0.001 for both.
CONCLUSION AND CLINICAL RELEVANCE


Fractional exhaled nitric oxide levels were higher in men than women. Similar effects of current smoking, height, and IgE sensitization were found in both sexes. F E  NO started increasing at lower age in women than in men, suggesting that interpretation of F E  NO levels in adults aged over 50 years should take into account age and sex.",2019,"Men and women sensitized to both grass and perennial allergens had higher F E  NO levels compared with non-sensitized subjects 26% and 29%, P ","['healthy individuals', 'men than women', '3881 healthy subjects that had answered the main questionnaire of the European Community Respiratory Health Survey III without airways or lung disease', 'men and women without lung diseases', 'healthy men and women from the European Community Respiratory Health Survey III']",['F E'],"['higher F E  NO levels', 'NO levels', 'current smoking, height, and IgE sensitization', 'Fractional exhaled nitric oxide levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0024115', 'cui_str': 'Disorder of lung'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C4523905', 'cui_str': 'Fractional exhaled nitric oxide'}]",3881.0,0.0267351,"Men and women sensitized to both grass and perennial allergens had higher F E  NO levels compared with non-sensitized subjects 26% and 29%, P ","[{'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Nerpin', 'Affiliation': 'Department of Medical Sciences, Respiratory Medicine, Allergy and Sleep, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Olivieri', 'Affiliation': 'Unit of Occupational Medicine, University of Verona, Verona, Italy.'}, {'ForeName': 'Thorainn', 'Initials': 'T', 'LastName': 'Gislason', 'Affiliation': 'Department of Sleep, Landspítali University Hospital, Reykjavík, Iceland.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Olin', 'Affiliation': 'Section of Occupational and Environmental Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Nielsen', 'Affiliation': 'Department of Clinical Science, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Ane', 'Initials': 'A', 'LastName': 'Johannessen', 'Affiliation': 'Department of Global Public Health and Primary Care, Centre for International Health, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Diogenes S', 'Initials': 'DS', 'LastName': 'Ferreira', 'Affiliation': 'School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Marcon', 'Affiliation': 'Unit of Epidemiology and Medical Statistics, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Cazzoletti', 'Affiliation': 'Unit of Epidemiology and Medical Statistics, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Accordini', 'Affiliation': 'Unit of Epidemiology and Medical Statistics, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Pin', 'Affiliation': 'Department of Pediatrics, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Corsico', 'Affiliation': 'Division of Respiratory Diseases, IRCCS Policlinico San Matteo Foundation, Pavia, Italy.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Demoly', 'Affiliation': 'Département de Pneumologie et Addictologie, Centre Hospitalier Universitaire de Montpellier, Hôpital Arnaud-de-Villeneuve, univ Montpellier, Montpellier, France.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Weyler', 'Affiliation': 'Epidemiology and Social Medicine, University of Antwerp StatUA Statistics Center, University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Nowak', 'Affiliation': 'Hospital of the Ludwig-Maximilian University Munich, LMU Munich, Munich, Germany.'}, {'ForeName': 'Rain', 'Initials': 'R', 'LastName': 'Jõgi', 'Affiliation': 'Lung Clinic, Tartu University Hospital, Tartu, Estonia.'}, {'ForeName': 'Bertil', 'Initials': 'B', 'LastName': 'Forsberg', 'Affiliation': 'Department of Public Health and Clinical Medicine, Occupational and Environmental Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Jan P', 'Initials': 'JP', 'LastName': 'Zock', 'Affiliation': 'ISGlobal, Barcelona, Spain.'}, {'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Sigsgaard', 'Affiliation': 'Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Heinric', 'Affiliation': 'Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, University Hospital Munich, Ludwig Maximilians University Munich, Munich, Germany.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Bono', 'Affiliation': 'Department of Public Health and Pediatrics, University of Turin, Turin, Italy.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Leynaert', 'Affiliation': 'INSERM, UMR1152, Paris, France.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Jarvis', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Christer', 'Initials': 'C', 'LastName': 'Janson', 'Affiliation': 'Department of Medical Sciences, Respiratory Medicine, Allergy and Sleep, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Anderi', 'Initials': 'A', 'LastName': 'Malinovschi', 'Affiliation': 'Department of Medical Sciences: Clinical Physiology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13394']
2732,31112494,Comparison of Parent Report with Administrative Data to Identify Pediatric Reutilization Following Hospital Discharge.,"Healthcare providers rely on historical data reported by parents to make medical decisions. The Hospital to Home Outcomes (H2O) trial assessed the effects of a onetime home nurse visit following pediatric hospitalization for common conditions. The H2O primary outcome, reutilization (hospital readmission, emergency department visit, or urgent care visit), relied on administrative data to identify reutilization events after discharge. We sought to compare parent recall of reutilization events two weeks after discharge with administrative records. Agreement was relatively high for any reutilization (kappa 0.74); however, this high agreement was driven by agreement between sources when no reutilization occurred (sources agreed 98%-99%). Agreement between sources was lower when reutilization occurred (48%-76%). Some discrepancies were related to parents misclassifying the site of care. The possibility of inaccurate parent report of reutilization has clinical implications that may be mitigated by confirmation of parent-reported data through verification with additional sources, such as electronic health record review.",2019,"The H2O primary outcome, reutilization (hospital readmission, emergency department visit, or urgent care visit), relied on administrative data to identify reutilization events after discharge.",[],[],"['reutilization (hospital readmission, emergency department visit, or urgent care visit), relied on administrative data to identify reutilization events after discharge']",[],[],"[{'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C2362545', 'cui_str': 'Urgent Care'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}]",,0.0879472,"The H2O primary outcome, reutilization (hospital readmission, emergency department visit, or urgent care visit), relied on administrative data to identify reutilization events after discharge.","[{'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Statile', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'White', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Heidi J', 'Initials': 'HJ', 'LastName': 'Sucharew', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': ""Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Tubbs-Cooley', 'Affiliation': 'The Ohio State University College of Nursing Center for Women, Children, and Youth, Columbus, Ohio.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Simmons', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Shah', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Auger', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of hospital medicine,['10.12788/jhm.3200']
2733,31557497,Impact of dermatology and teledermatology consultations for patients admitted with cellulitis: A pilot study.,,2020,,['patients admitted with cellulitis'],['dermatology and teledermatology consultations'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}]","[{'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",[],,0.0242381,,"[{'ForeName': 'Preeta', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': 'Ohio State University College of Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Starling', 'Initials': 'S', 'LastName': 'Tolliver', 'Affiliation': 'Ohio State University College of Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Myron', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Internal Medicine, Division of Dermatology, The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Schumacher', 'Affiliation': 'Department of Internal Medicine, Division of Hospital Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio.'}, {'ForeName': 'Benjamin H', 'Initials': 'BH', 'LastName': 'Kaffenberger', 'Affiliation': 'Department of Internal Medicine, Division of Dermatology, The Ohio State University Wexner Medical Center, Columbus, Ohio. Electronic address: preetagupta333@gmail.com.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.09.022']
2734,32817932,Closing the gap: A novel metric of change in performance.,"BACKGROUND


Interventions to improve performance of global programs in the HIV cascade of care are widespread and increasing the focus of implementation science. At present, however, there is no clear consensus on how to conceptualize their improvement at the program level. The commonly used measures of association, based on ratios of probabilities (or odds), have well-known defects in public health applications. They yield large effect sizes even when the absolute effects, and therefore the public health impact, are small. On the other hand, risk differences create problems because settings with higher baseline values are penalized. We aim to examine ways of quantifying improvement in each health center of a cluster-randomized trial in Uganda to accelerate antiretroviral therapy initiation among HIV-infected adults.
METHODS


We formalize the concept of the 'improvement index,' defined as the fraction of gaps closed as a metric of improvement, and suggest that it has unique features and strengths when compared to risk ratios and risk differences.
RESULTS


Overall agreement between the different indices was not high, especially among health centers that were among the top 5 or 10. However, all ranking showed broad similarities at the far ends of the spectrum. On scatter plots, there was a positive linear relationship between the metrics, and the Bland Altman (B-A) plots were in agreement.
CONCLUSION


The improvement index can be used as an alternative measure of association in implementation science interventions. It can be useful for public health purposes as it demonstrates how much can be covered from the baseline.",2019,"RESULTS


Overall agreement between the different indices was not high, especially among health centers that were among the top 5 or 10.",['HIV-infected adults'],[],[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],,0.0520189,"RESULTS


Overall agreement between the different indices was not high, especially among health centers that were among the top 5 or 10.","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Katuramu', 'Affiliation': 'Makerere University, Kampala, Uganda.'}, {'ForeName': 'Jeanna', 'Initials': 'J', 'LastName': 'Wallenta', 'Affiliation': 'Department of Medicine, Division of HIV, ID and Global Medicine, University of California, San Francisco, USA.'}, {'ForeName': 'Fred C', 'Initials': 'FC', 'LastName': 'Semitala', 'Affiliation': 'Makerere University, Kampala, Uganda.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Amanyire', 'Affiliation': 'Makerere University Joint AIDS Program, Kampala, Uganda.'}, {'ForeName': 'Leatitia', 'Initials': 'L', 'LastName': 'Kampiire', 'Affiliation': 'Makerere University, Kampala, Uganda.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Namusobya', 'Affiliation': 'Makerere University Joint AIDS Program, Kampala, Uganda.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Makerere University, Kampala, Uganda.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Havlir', 'Affiliation': 'Department of Medicine, Division of HIV, ID and Global Medicine, University of California, San Francisco, USA.'}, {'ForeName': 'David V', 'Initials': 'DV', 'LastName': 'Glidden', 'Affiliation': 'Department of Medicine, Division of HIV, ID and Global Medicine, University of California, San Francisco, USA.'}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Geng', 'Affiliation': 'Department of Medicine, Division of HIV, ID and Global Medicine, University of California, San Francisco, USA.'}]",East African journal of applied health monitoring and evaluation,[]
2735,32818112,Bradykinin 1 Receptor Antagonist BI1026706 Does Not Reduce Central Retinal Thickness in Center-Involved Diabetic Macular Edema.,"Purpose


The bradykinin 1 receptor may be important in inflammatory retinal vascular leakage in diabetic macular edema. BI 1026706 is an antagonist of bradykinin 1 receptor that has demonstrated efficacy in preclinical studies. Boehringer Ingelheim trial 1320.22 (NCT02732951) was a randomized, double-blind, placebo-controlled study. The pharmacodynamics, safety, and tolerability of oral BI 1026706 for 12 weeks were evaluated in patients with type 1 or type 2 diabetes mellitus and mild visual impairment owing to center-involved diabetic macular edema.
Methods


Patients ( n  = 105) were randomized to receive either oral BI 1026706 100 mg twice daily (morning and evening) or placebo for 12 weeks. The primary end point of the study was week 12 change from baseline in central subfield foveal thickness (CSFT) by spectral domain optical coherence tomography. Additional end points included absolute CSFT values, safety, and pharmacokinetics.
Results


After 12 weeks of treatment, there was no meaningful change from baseline in the adjusted mean CSFT in either treatment group (BI 1026706, 10.3 µm; placebo, -6.2 µm; adjusted mean treatment difference, 16.5 µm [95% confidence interval, -16.2 to 49.1]). There were also no differences in best-corrected visual acuity outcomes between treatment groups. Most reported adverse events were of mild or moderate intensity, and were balanced between treatment groups.
Conclusions


BI 1026706 was not superior to placebo in CSFT week-12 change from baseline. Therefore, BI 1026706 does not reduce CSFT, a morphologic sign of diabetic macular edema.
Translational Relevance


Kinin-kallikrein inhibition effects may not be apparent over 12 weeks for bradykinin 1 receptor inhibition alone.",2020,"After 12 weeks of treatment, there was no meaningful change from baseline in the adjusted mean CSFT in either treatment group (BI 1026706, 10.3 µm; placebo, -6.2 µm; adjusted mean treatment difference, 16.5 µm [95% confidence interval, -16.2 to 49.1]).","['Methods\n\n\nPatients ( n  = 105', 'patients with type 1 or type 2 diabetes mellitus and mild visual impairment owing to center-involved diabetic macular edema', 'diabetic macular edema']","['oral BI 1026706 100 mg twice daily (morning and evening) or placebo', 'placebo']","['absolute CSFT values, safety, and pharmacokinetics', 'best-corrected visual acuity outcomes', 'Central Retinal Thickness', 'adverse events', 'central subfield foveal thickness (CSFT', 'pharmacodynamics, safety, and tolerability']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C1301511', 'cui_str': 'Mild visual impairment'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}]",105.0,0.331544,"After 12 weeks of treatment, there was no meaningful change from baseline in the adjusted mean CSFT in either treatment group (BI 1026706, 10.3 µm; placebo, -6.2 µm; adjusted mean treatment difference, 16.5 µm [95% confidence interval, -16.2 to 49.1]).","[{'ForeName': 'Gabriele E', 'Initials': 'GE', 'LastName': 'Lang', 'Affiliation': 'University of Ulm, Ulm, Germany.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Tadayoni', 'Affiliation': 'Ophthalmology Department, AP-HP, Hôpital Lariboisière, Université de Paris, F-75010, Paris, France.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Barth', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Weiss-Haljiti', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co., Biberach, Germany.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Chong', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Translational vision science & technology,['10.1167/tvst.9.4.25']
2736,32818196,Text Messaging as a Teaching Tool in a Family Medicine Clerkship Rotation.,"Introduction


Today's learners use multiple forms of social communication, such as text messaging, that offer a promising teaching tool for medical education. The purpose of this study was to evaluate a diabetes care curriculum delivered through text messages for third-year medical students on a rural family medicine clerkship.
Methods


A pilot study of 119 participants were compared in a parallel group randomized controlled trial evaluating medical student learning and satisfaction with text messages throughout rotation compared to an email with the same content in their first week of rotation. Participants completed a 10-question multiple-choice test and six survey questions upon completing the rotation. The primary outcome was a difference between test scores among the two groups, and student satisfaction with the educational intervention was a secondary outcome.
Results


A total of 85 participants successfully completed the study protocol (34 text messages and 51 email) and were included in a per protocol analysis. The average number of correct responses per test was 3.32 (SD 1.29) in the texting group and 3.69 (SD 1.53) in the email group ( P =0.259). Student satisfaction with text messages was 3.68 (SD 0.87) compared to email at 2.02 (SD 0.95) when rating the educational intervention on a 1 to 5 Likert scale (1=poor, 3=average, and 5=excellent).
Conclusions


Participant knowledge on a challenging posttest was not improved with text messages compared to an email in this pilot study. Satisfaction with text messages was primarily positive. Further study is needed to determine the effectiveness of this content delivery method.",2018,The average number of correct responses per test was 3.32 (SD 1.29) in the texting group and 3.69 (SD 1.53) in the email group ( P =0.259).,"['third-year medical students on a rural family medicine clerkship', '119 participants', '85 participants successfully completed the study protocol (34 text messages and 51 email) and were included in a per protocol analysis']",['medical student learning and satisfaction with text messages throughout rotation'],"['Student satisfaction with text messages', 'average number of correct responses per test']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",119.0,0.107364,The average number of correct responses per test was 3.32 (SD 1.29) in the texting group and 3.69 (SD 1.53) in the email group ( P =0.259).,"[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Bragg', 'Affiliation': 'Department of Family Medicine, Medical University of South Carolina, and Clinical Pharmacy and Outcomes Sciences, Medical University of South Carolina College of Pharmacy, Charleston, SC.'}, {'ForeName': 'Kristen Hood', 'Initials': 'KH', 'LastName': 'Watson', 'Affiliation': 'Department of Family Medicine, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Kern', 'Affiliation': 'Department of Family Medicine, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Wessell', 'Affiliation': 'Department of Family Medicine, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Alexander W', 'Initials': 'AW', 'LastName': 'Chessman', 'Affiliation': 'Department of Family Medicine, Medical University of South Carolina, Charleston, SC.'}]","PRiMER (Leawood, Kan.)",['10.22454/PRiMER.2018.992114']
2737,32818546,Consumers' reactions to nutrition and ingredient labelling for wine - A cross-country discrete choice experiment.,"The purpose of this study is to examine consumers' reactions to the introduction of nutrition and ingredient labelling for wine, a product that is so far still exempt from mandatory nutrition and ingredient labelling. It also analyses the effect of positive and negative information about the use of ingredients in wine on consumers' choice. Representative samples for wine consumers from three distinctly different countries representing old and new wine markets (Australia, n = 745; Germany, n = 716; Italy, n = 715) completed a discrete choice experiment (DCE) with graphically simulated wine back labels. For each country, respondents were randomly allocated to a reference group and two different treatment conditions where they received newspaper-like information (positive, negative) before making choices. Results for the reference condition show that consumers across all three countries have a significant positive utility for detailed nutrition information. Instead, ingredient information only receives a positive utility in Italy, whereas German and Australian respondents do not receive utility from ingredient labelling. When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine. The treatment effect of positive media information on consumers' wine choice is lower than that of negative information. The results of the study have implications for the pending new regulation of wine labelling and for communication strategies of the wine industry that should actively inform consumers about the necessity of ingredients in wine production.",2020,"When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine.","['Representative samples for wine consumers from three distinctly different countries representing old and new wine markets (Australia, n\u202f=\u202f745; Germany, n\u202f=\u202f716; Italy, n\u202f=\u202f715) completed a']",['discrete choice experiment (DCE) with graphically simulated wine back labels'],[],"[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C1318228', 'cui_str': 'Market'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0043188', 'cui_str': 'Wine'}]",[],745.0,0.025423,"When consumers in the treatment group are confronted with negative media information the attribute importance of ingredients significantly increases across all three countries, clean labelled products without ingredients are preferred, and a significantly higher share of consumers in Germany and Italy prefer not to buy any wine.","[{'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Pabst', 'Affiliation': 'Geisenheim University, Von-Lade-Str. 1, 65395, Geisenheim, Germany. Electronic address: Evelyn.Pabst@hs-gm.de.'}, {'ForeName': 'Armando Maria', 'Initials': 'AM', 'LastName': 'Corsi', 'Affiliation': 'Ehrenberg-Bass Instiute for Marketing Science, University of South, North Terrace, Adelaide, SA, 5000, Australia. Electronic address: Armando.Corsi@unisa.edu.au.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Vecchio', 'Affiliation': 'Department of Agricultural Science, University of Naples Federico II, Via Università, 100, 80055, Portici (Naples), Italy. Electronic address: riccardo.vecchio@unina.it.'}, {'ForeName': 'Azzurra', 'Initials': 'A', 'LastName': 'Annunziata', 'Affiliation': 'Department of Economic and Legal Studies, University of Naples ""Parthenope"", Via G. Parisi, 13, 80133, Naples, Italy. Electronic address: azzurra.annunziata@uniparthenope.it.'}, {'ForeName': 'Simone Mueller', 'Initials': 'SM', 'LastName': 'Loose', 'Affiliation': 'Geisenheim University, Von-Lade-Str. 1, 65395, Geisenheim, Germany; Ehrenberg-Bass Instiute for Marketing Science, University of South, North Terrace, Adelaide, SA, 5000, Australia. Electronic address: Simone.Loose@hs-gm.de.'}]",Appetite,['10.1016/j.appet.2020.104843']
2738,32818573,"Clinical evaluation of the pharmacological impact of ashwagandha root extract on sleep in healthy volunteers and insomnia patients: A double-blind, randomized, parallel-group, placebo-controlled study.","ETHNOPHARMACOLOGICAL RELEVANCE


Ashwagandha (Withania somnifera (L.) Dunal.) is long known for its sleep-inducing effects. Ashwagandha can be proposed as an alternative to the recommended present treatments for insomnia. This study aimed to evaluate the pharmacological effect of Ashwagandha root extract on sleep in healthy subjects and also in the subjects having insomnia.
MATERIAL AND METHODS


We performed a randomized, parallel-group, stratified design, placebo-controlled study. A total of 80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia) were assigned to two groups, either Ashwagandha or placebo and studied for 8-weeks. The assessment was done based on the sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake After Sleep Onset, Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire. Safety and adverse events along with the concomitant medication were also assessed.
RESULTS


In both healthy and insomnia subjects, there was a significant improvement in the sleep parameters in the Ashwagandha root extract supplemented group. The improvement was found more significant in insomnia subjects than healthy subjects. Repeat measure Analysis of variance (ANOVA) confirmed the significant improvement in SOL (p 0.013), HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients. A two-way ANOVA was used to confirm the outcomes that denoted sleep onset latency (p < 0.0001) and sleep efficiency (p < 0.0001) as the most improved parameters, followed by TST (p < 0.002) and WASO(p < 0.040). All these parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality) were also statistically assessed for the significant improvement within the group both for the treatment, and the placebo groups in the healthy and the insomnia datasets. Obtained results suggest statistically significant (p < 0.0001) changes between the baseline values and the end of the study results except for the HAM-A and the mental alertness scoresn the healthy subject group.
CONCLUSION


The present study confirms that Ashwagandha root extract can improve sleep quality and can help in managing insomnia. Ashwagandha root extract was well tolerated by all the participants irrespective of their health condition and age. Additional clinical trials are required to generalize the outcome.",2020,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","['80 eligible participants, 40 in Arm-A (healthy) and 40 in Arm-B (insomnia', 'healthy subjects and also in the subjects having insomnia', 'healthy volunteers and insomnia patients']","['Ashwagandha root extract', 'ashwagandha root extract', 'Ashwagandha or placebo', 'placebo']","['parameters (SOL, TST, WASO, TIB, SE, PSQI, HAM-A, Mental Alertness, and Sleep quality', 'sleep parameters', 'insomnia subjects', 'mental alertness', 'sleep parameters (Sleep Onset Latency, Total Sleep Time, Wake', 'sleep efficiency', 'Safety and adverse events', 'sleep quality', 'SOL', 'Total time in bed, and Sleep Efficiency), Pittsburgh Sleep Quality Index and Hamilton Anxiety scale-A questionnaire, mental alertness on rising assessment, and sleep quality questionnaire']","[{'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0549164', 'cui_str': 'Mental alertness'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",80.0,0.0352543,"HAM-A outcomes (p < 0.05), mental alertness (p 0.01), and sleep quality (p < 0.05) of the insomnia patients.","[{'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Langade', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India. Electronic address: deepak.langade@dypatil.edu.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Thakare', 'Affiliation': 'D Y Patil University School of Medicine, Navi Mumbai, 400706, Maharashtra, India.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Kanchi', 'Affiliation': 'Vedantaa Institute of Medical Sciences, Dahanu, Palghar, 401606, Maharashtra, India.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kelgane', 'Affiliation': 'Maharashtra Emergency Medical Services, Defence Area, Pimple Gurav, Pimpri-Chinchwad, 411027, Maharashtra, India.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113276']
2739,32818600,Differential activation and functional plasticity of multimodal areas associated with acquired musical skill.,"Training of a musical skill is known to produce a distributed neural representation of the ability to perceive music and perform musical tasks. In the present study we tested the hypothesis that the audiovisual perception of music involves a wider activation of multimodal sensory and sensorimotor structures in the brain, including those containing mirror neurons. We mapped the activation of brain areas during passive listening and viewing of the first 40 s of ""Ode to Joy"" being played on the piano by an expert pianist. To do this we performed brain functional magnetic resonance imaging during the presentation of 6 different stimulus contrasts pertaining to that musical melody in a pseudo-randomized order. Group data analysis in musically trained and untrained adults showed robust activation in broadly distributed occipitotemporal, parietal and frontal areas in trained subjects and much restricted activation in untrained subjects. A visual stimulus contrast focusing on the visual motion percept of moving fingers on piano keys revealed selective bilateral activation of a locus corresponding to the V5/MT area, which was significantly more pronounced in trained subjects and showed partial linear dependence on the duration of training on the left side. Quantitative analysis of individual brain volumes confirmed a significantly greater and wider spread of activation in trained compared to untrained subjects. These findings support the view that audiovisual perception of music and musical gestures in trained musicians involves an expanded and widely distributed neural representation formed due to experience-dependent plasticity.",2020,Quantitative analysis of individual brain volumes confirmed a significantly greater and wider spread of activation in trained compared to untrained subjects.,['musically trained and untrained adults'],[],[],"[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],[],,0.0215397,Quantitative analysis of individual brain volumes confirmed a significantly greater and wider spread of activation in trained compared to untrained subjects.,"[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Srinivasan', 'Affiliation': 'Speech and Language Center, Stanley H. Appel Department of Neurology, Houston Methodist Neurological Institute, United States.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bishop', 'Affiliation': 'Speech and Language Center, Stanley H. Appel Department of Neurology, Houston Methodist Neurological Institute, United States.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Yekovich', 'Affiliation': 'Shepherd School of Music, Rice University, Houston, Texas, United States.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Rosenfield', 'Affiliation': 'Speech and Language Center, Stanley H. Appel Department of Neurology, Houston Methodist Neurological Institute, United States; Shepherd School of Music, Rice University, Houston, Texas, United States.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Helekar', 'Affiliation': 'Speech and Language Center, Stanley H. Appel Department of Neurology, Houston Methodist Neurological Institute, United States. Electronic address: sahelekar@houstonmethodist.org.'}]",Neuroscience,['10.1016/j.neuroscience.2020.08.013']
2740,32818641,The effect of laser-activated bleaching with 445 nm and 915 nm diode lasers on enamel micro-hardness; an in vitro study.,"BACKGROUND


The appearance of the teeth is of great importance to patients, particularly tooth color. In recent years, tooth whitening has been one of the most popular ways to restore tooth color. Bleaching gels can be affected by heat, light or laser, which can improve its effects. This study intends to examine the effects of two different wavelengths of diode laser (445 & 915 nm) after the bleaching process, on the enamel micro-hardness.
METHODS


A total of 65 caries-free humans third molars were randomly divided into five groups (N = 13): first group: bleaching gel activated with 915 nm diode laser (1.5 W), second: bleaching gel activated with 915-nm (2.5 W), third: bleaching gel activated with 445-nm (1 W), fourth: bleaching gel activated with 445-nm (1.5 W), fifth (control group): bleaching gel without laser activation. Micro-hardness test (Vickers test) was performed before and after the treatment. The data were submitted to repeated measurement ANOVA and Tukey's HSD post hoc test (α = 0.05).
RESULTS


Enamel micro-hardness did not change significantly in groups 3 and 4 but decreased in groups 1 and 2. Group 2 showed the most reduction in micro-hardness. There were no significant changes in the control group.
CONCLUSION


According to the results of this study, 445 nm Diode laser did not reduce enamel micro-hardness, making it suitable for bleaching treatments. However, more studies are required to consider other factors, such as color changes and pulp temperature.",2020,"RESULTS


Enamel micro-hardness did not change significantly in groups 3 and 4 but decreased in groups 1 and 2.",['65 caries-free humans third molars'],"['diode laser', 'bleaching gel activated with 915\u2009nm diode laser (1.5\u2009W), second: bleaching gel activated with 915-nm (2.5\u2009W), third: bleaching gel activated with 445-nm (1\u2009W), fourth: bleaching gel activated with 445-nm (1.5\u2009W), fifth (control group): bleaching gel without laser activation', 'laser-activated bleaching with 445\u2009nm and 915\u2009nm diode lasers']","['Enamel micro-hardness', 'micro-hardness']","[{'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0026369', 'cui_str': 'Structure of wisdom tooth'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}]","[{'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure'}, {'cui': 'C0018599', 'cui_str': 'Hard'}]",65.0,0.0117176,"RESULTS


Enamel micro-hardness did not change significantly in groups 3 and 4 but decreased in groups 1 and 2.","[{'ForeName': 'Sogol', 'Initials': 'S', 'LastName': 'Saberi', 'Affiliation': 'Laser Research Center, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahboubeh', 'Initials': 'M', 'LastName': 'Rouzsaz', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran. Electronic address: mahboobeh.roozsaz@gmail.com.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Shafie', 'Affiliation': 'Department of Dental Biomaterials, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sadra', 'Initials': 'S', 'LastName': 'Einizadeh', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Javad', 'Initials': 'MJ', 'LastName': 'Kharazifard', 'Affiliation': 'Dental Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Shahabi', 'Affiliation': 'Department of Dental Biomaterials, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: shahabis@sina.tums.ac.ir.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101952']
2741,32818647,Effect of Photodynamic Therapy on Microleakage of Class V Composite Restorations in Primary Teeth.,"BACKGROUND


Photodynamic therapy (PDT) is a treatment by which, chemicals are activated at a specific wavelength, generating reactive oxygen species and causing disinfection. However, the residual oxygen radicals may interfere with the bonding process. The purpose of this study was to assess the effect of PDT with different photosensitizers on microleakage of composite restorations.
METHODS


Seventhy-two primary teeth with sound labial/buccal and lingual surfaces were collected for this study. The teeth were randomly divided into four groups of control, PDT with indocyanine green, PDT with methylene blue, and PDT with toluidine blue. Next, the cavities were restored with composite resin. The specimens were stained with 0.5% Fuchsine and sectioned. The specimens were observed under a microscope to determine the microleakage score. The microleakage was compared between the groups and between the occlusal and cervical walls in each group. Data were analyzed using SPSS version 25.
RESULTS


According to the kruskal-wallis test, no significant difference was observed in microleakage between the groups in the occlusal wall (p = 0.859). However, there was a significant difference in the cervical wall between the control and toluidine blue (p = 0.019), and the control and methylene blue (p = 0.008) groups. The Wilcoxon test showed a significant difference in microleakage (p < 0.05) between the occlusal and cervical walls within each group.
CONCLUSIONS


PDT may be used in cavities with enamel margins to decrease the microbial load and prevent secondary caries. PDT is not recommended for cavities with cementum margins. Alternatively, it can be performed with indocyanine green as photosensitizer in such cases.",2020,"The Wilcoxon test showed a significant difference in microleakage (p < 0.05) between the occlusal and cervical walls within each group.
","['Seventhy-two primary teeth with sound labial/buccal and lingual surfaces', 'Microleakage of Class V Composite Restorations in Primary Teeth']","['Photodynamic therapy (PDT', 'control, PDT with indocyanine green, PDT with methylene blue, and PDT with toluidine blue', 'PDT', 'Photodynamic Therapy', 'indocyanine green']",['microleakage'],"[{'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0023759', 'cui_str': 'Lip structure'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0447311', 'cui_str': 'Structure of lingual surface of tooth'}, {'cui': 'C0457166', 'cui_str': 'Class 5'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0040380', 'cui_str': 'Tolonium chloride'}]",[],,0.0225605,"The Wilcoxon test showed a significant difference in microleakage (p < 0.05) between the occlusal and cervical walls within each group.
","[{'ForeName': 'Ali Eslambol', 'Initials': 'AE', 'LastName': 'Nassaj', 'Affiliation': 'Resident of Endodontics, Department of Endodontics, School of Dentistry, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ghadimi', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahman', 'Initials': 'B', 'LastName': 'Seraj', 'Affiliation': 'Department of Pediatric Dentistry, Faculty of Dentistry, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: serajbah@tums.ac.ir.'}, {'ForeName': 'Nasim', 'Initials': 'N', 'LastName': 'Chiniforush', 'Affiliation': 'Laser Research Center of Dentistry, Dentistry Research Institute, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: n-chiniforush@farabi.tums.ac.ir.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101964']
2742,32819191,A pilot study investigating the impact of a caffeine-nap on alertness during a simulated night shift.,"Consuming coffee immediately prior to a nap, known as a caffeine-nap, has been shown to improve alertness during the day, but it is unknown whether a caffeine-nap is effective at reducing sleep inertia during the night. A simulated shiftwork cross-over laboratory study was conducted whereby participants (N = 6, 4 F, 21-36y) consumed 200 mg of caffeine, or decaffeinated coffee (placebo), immediately prior to a 30 min nap opportunity at 03:30 h. Compared to placebo, the caffeine-nap resulted in improved vigilant attention and subjective fatigue in the 45 min post-nap opportunity. The caffeine-nap may be useful in reducing sleep inertia in shift workers who nap on nightshift.",2020,"Compared to placebo, the caffeine-nap resulted in improved vigilant attention and subjective fatigue in the 45 min post-nap opportunity.","['participants (N\xa0=\xa06, 4\xa0F, 21-36y) consumed 200 mg of']","['caffeine, or decaffeinated coffee (placebo', 'caffeine-nap', 'placebo']","['vigilant attention and subjective fatigue', 'sleep inertia']","[{'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}]","[{'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1963765', 'cui_str': 'Sleep inertia'}]",,0.02922,"Compared to placebo, the caffeine-nap resulted in improved vigilant attention and subjective fatigue in the 45 min post-nap opportunity.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Centofanti', 'Affiliation': 'UniSA Online, University of South Australia , Adelaide, Australia.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Banks', 'Affiliation': 'Sleep and Chronobiology Laboratory, University of South Australia , Adelaide, Australia.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Coussens', 'Affiliation': 'Sleep and Chronobiology Laboratory, University of South Australia , Adelaide, Australia.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Gray', 'Affiliation': 'Sleep and Chronobiology Laboratory, University of South Australia , Adelaide, Australia.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Munro', 'Affiliation': 'Sleep and Chronobiology Laboratory, University of South Australia , Adelaide, Australia.'}, {'ForeName': 'Johnathon', 'Initials': 'J', 'LastName': 'Nielsen', 'Affiliation': 'Sleep and Chronobiology Laboratory, University of South Australia , Adelaide, Australia.'}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Dorrian', 'Affiliation': 'Sleep and Chronobiology Laboratory, University of South Australia , Adelaide, Australia.'}]",Chronobiology international,['10.1080/07420528.2020.1804922']
2743,32819209,Designing creative spaces: An experimental examination of the effect of a nature poster on divergent thinking.,"This paper reports the results of an independent samples experiment designed to examine the effects of the presence of a large poster depicting a natural woodland scene on individual performance on two Divergent Thinking tasks. In comparison to the no-poster control condition, the presentation of a large poster depicting a nature scene was found to lead to greater levels of creativity as rated by judges who were blind to the experimental design. The effects of the large poster on Divergent Thinking were found to hold when controlling for Openness-to-Experience and Mood. Exploratory analyses of participant ratings of room characteristics indicated that the mechanism underlying the posters' effect related to elevated stimulation. Practitioner Summary:  This study compared the effects of presenting a large poster depicting a natural woodland scene (experimental condition) versus no poster (control condition) on individual creative thinking. Three judges, who were unaware of the design of the study, did not know the participant responses were from two different conditions and who did not facilitate the experiment rated the responses of the participants who were exposed to the large poster as significantly more creative.",2020,The effects of the large poster on Divergent Thinking were found to hold when controlling for Openness-to-Experience and Mood.,[],['large poster depicting a natural woodland scene (experimental condition) versus no poster (control condition'],[],[],"[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],2.0,0.0183787,The effects of the large poster on Divergent Thinking were found to hold when controlling for Openness-to-Experience and Mood.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Batey', 'Affiliation': 'Manchester Metropolitan University Business School, UK.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Hughes', 'Affiliation': 'Alliance Manchester Business School, The University of Manchester, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Crick', 'Affiliation': 'PriceWaterhouseCoopers, UK.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Toader', 'Affiliation': 'Alliance Manchester Business School, The University of Manchester, UK.'}]",Ergonomics,['10.1080/00140139.2020.1811398']
2744,32819304,"The impact of high-intensity interval training exercise on breast cancer survivors: a pilot study to explore fitness, cardiac regulation and biomarkers of the stress systems.","BACKGROUND


Cardiovascular disease (CVD) remains the largest cause of death in breast cancer survivors. The aim of this study was to explore the impact of exercise intensity on aerobic fitness and autonomic cardiac regulation (heart rate variability (HRV)) and salivary biomarkers of the stress systems (HPA-axis, cortisol; sympathetic nervous system, α-amylase) and mucosal immunity (secretory(s)-IgA), markers of increased risk of CVD in breast cancer survivors.
METHODS


Participants were randomly assigned to; 1) high intensity interval training (HIIT); 2) moderate-intensity, continuous aerobic training (CMIT); or 3) a wait-list control (CON) for a 12-week (36 session) stationary cycling intervention. Cardiorespiratory fitness (VO 2peak ), resting HRV and salivary biomarkers were measured at baseline 2-4 d pre-intervention and 2-4 d post the last exercise session.
RESULTS


Seventeen participants were included in this study (62 ± 8 years, HIIT; n = 6, CMIT; n = 5, CON; n = 6). A significant improvement (p ≤ 0.05) was observed for VO 2peak  in the HIIT group; 19.3% (B = 3.98, 95%CI = [1.89; 4.02]) and a non-significant increase in the CMIT group; 5.6% (B = 1.96, 95%CI = [- 0.11; 4.03]), compared with a 2.6% (B = - 0.64, 95%CI = [- 2.10; 0.82]) decrease in the CON group. Post intervention improvements in HRV markers of vagal activity (log (ln)LF/HF, LnRMSSD) and sympathetic nervous system (α-amylase waking response) occurred for individuals exhibiting outlying (> 95% CI) levels at baseline compared to general population.
CONCLUSION


High intensity interval training improved cardiovascular fitness in breast cancer survivors and improved cardiac regulation, and sympathetic nervous system (stress) responses in some individuals. High-intensity interval training was safe and effective for breast cancer survivors to participate in with promising results as a time efficient intensity to improve physical health and stress, reducing CVD risk.
TRIAL REGISTRATION


This pilot study was retrospectively registered through the Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12620000684921 .",2020,"A significant improvement (p ≤ 0.05) was observed for VO 2peak  in the HIIT group; 19.3% (B = 3.98, 95%CI = [1.89; 4.02]) and a non-significant increase in the CMIT group; 5.6% (B = 1.96, 95%CI = [- 0.11; 4.03]), compared with a 2.6% (B = - 0.64, 95%CI = [- 2.10; 0.82]) decrease in the CON group.","['Seventeen participants were included in this study (62\u2009±\u20098\u2009years, HIIT; n\u2009=\u20096, CMIT; n\u2009=\u20095, CON; n\u2009=\u20096', 'Participants were randomly assigned to; 1', 'breast cancer survivors', 'Australian New Zealand Clinical Trials Registry (ANZCTR']","['high intensity interval training (HIIT); 2) moderate-intensity, continuous aerobic training (CMIT); or 3) a wait-list control (CON', 'high-intensity interval training exercise', 'High-intensity interval training', 'High intensity interval training']","['VO 2peak', 'cardiovascular fitness', 'cardiac regulation, and sympathetic nervous system (stress) responses', 'Cardiorespiratory fitness (VO 2peak ), resting HRV and salivary biomarkers', 'physical health and stress, reducing CVD risk', 'aerobic fitness and autonomic cardiac regulation (heart rate variability (HRV)) and salivary biomarkers of the stress systems (HPA-axis, cortisol; sympathetic nervous system, α-amylase) and mucosal immunity (secretory(s)-IgA), markers of increased risk of CVD', 'HRV markers of vagal activity (log (ln)LF/HF, LnRMSSD) and sympathetic nervous system (α-amylase waking response']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0282558', 'cui_str': 'Mucosal Immunity'}, {'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",17.0,0.0895355,"A significant improvement (p ≤ 0.05) was observed for VO 2peak  in the HIIT group; 19.3% (B = 3.98, 95%CI = [1.89; 4.02]) and a non-significant increase in the CMIT group; 5.6% (B = 1.96, 95%CI = [- 0.11; 4.03]), compared with a 2.6% (B = - 0.64, 95%CI = [- 2.10; 0.82]) decrease in the CON group.","[{'ForeName': 'Kellie', 'Initials': 'K', 'LastName': 'Toohey', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia. kellie.toohey@canberra.edu.au.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Pumpa', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McKune', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Cooke', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Marijke', 'Initials': 'M', 'LastName': 'Welvaert', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Northey', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Quinlan', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Semple', 'Affiliation': 'Research Institute for Sport and Exercise, University of Canberra, Canberra, 2601, Australia.'}]",BMC cancer,['10.1186/s12885-020-07295-1']
2745,32819305,Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-022 with reference trastuzumab.,"BACKGROUND


BCD-022 is a trastuzumab biosimilar which was shown to be equivalent to reference trastuzumab in a wide panel of physicochemical studies as well as preclinical studies in vitro and in vivo. International multicenter phase III clinical trial was conducted to comparatively assess efficacy and safety of BCD-022 and reference trastuzumab in combination with paclitaxel used as the therapy of metastatic HER2(+) breast cancer. Pharmacokinetics and immunogenicity were also studied.
METHODS


Patients with no previous treatment for metastatic HER2(+) breast cancer were randomly assigned 1:1 to BCD-022 or reference trastuzumab and were treated with trastuzumab + paclitaxel. Therapy continued for 6 cycles of therapy (every 3 weeks), until progression of the disease or unbearable toxicity. Primary study endpoint was overall response rate. Study goal was to prove equivalent efficacy of BCD-022 and reference trastuzumab. Equivalence margins for 95% CI for difference in overall response rates were set at [- 20%; 20%].
RESULTS


In total 225 patients were enrolled into the study, 115 in BCD-022 arm and 110 in reference trastuzumab arm. Overall response rate was 49.6% in BCD-022 arm and 43.6% in reference trastuzumab arm. Limits of 95% CI for difference of overall response rates between arms were [(- 8.05)-19.89%], thus, they lied within predetermined equivalence margins [- 20%; 20%]. Profile of adverse events was similar between groups (any AEs were reported in 93.81% of patients in BCD-022 arm and 94.55% of patients in reference arm). No unexpected adverse reactions were reported throughout the study. No statistically significant differences regarding antibody occurrence rate (either BAb or NAb) was found between BCD-022 (n = 3; 2.65%) and comparator (n = 4; 3.64%). Both drug products are characterized with low occurrence rate and short life of anti-trastuzumab antibodies. Pharmacokinetics assessment after 1st and 6th study drug injection also demonstrated equivalent PK parameters by all outcome measures: AUC 0-504 , С mах , Т max , T 1/2 . Analysis of C trough  did not reveal any significant inter-group differences as well.
CONCLUSIONS


Thus, results of this study have demonstrated therapeutic equivalence of trastuzumab biosimilar BCD-022 and referent trastuzumab drug.
TRIAL REGISTRATION


The trial was registered with ClinicalTrials.gov (Study Number NCT01764022 ). The date of registration was January 9, 2013.",2020,Profile of adverse events was similar between groups (any AEs were reported in 93.81% of patients in BCD-022 arm and 94.55% of patients in reference arm).,"['Patients with no previous treatment for metastatic HER2(+) breast cancer', 'metastatic HER2(+) breast cancer', 'In total 225 patients were enrolled into the study, 115 in BCD-022 arm and 110 in reference trastuzumab arm']","['BCD-022 and reference trastuzumab', 'paclitaxel', 'biosimilar BCD-022 with reference trastuzumab', 'trastuzumab + paclitaxel', 'BCD-022 or reference trastuzumab']","['equivalent PK parameters', 'overall response rates', 'overall response rate', 'adverse events', 'adverse reactions', 'antibody occurrence rate (either BAb or NAb', 'Pharmacokinetics and immunogenicity', 'Overall response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0303407', 'cui_str': 'Indium-115'}, {'cui': 'C0053048', 'cui_str': 'BCD protocol'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0303401', 'cui_str': 'Indium-110'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0053048', 'cui_str': 'BCD protocol'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",225.0,0.296749,Profile of adverse events was similar between groups (any AEs were reported in 93.81% of patients in BCD-022 arm and 94.55% of patients in reference arm).,"[{'ForeName': 'Sergey M', 'Initials': 'SM', 'LastName': 'Alexeev', 'Affiliation': 'N.N. Petrov NII of Oncology of the Ministry of Healthcare of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Andrey V', 'Initials': 'AV', 'LastName': 'Khorinko', 'Affiliation': 'SBHI of PK Perm Krai, Perm Krai Cancer Dispensary, Perm, Russian Federation.'}, {'ForeName': 'Guzel Z', 'Initials': 'GZ', 'LastName': 'Mukhametshina', 'Affiliation': 'SAHI Republican Clinical Cancer Dispensary of the Ministry of Healthcare of the Republic of Tatarstan, Kazan, Russian Federation.'}, {'ForeName': 'Konstantin G', 'Initials': 'KG', 'LastName': 'Shelepen', 'Affiliation': 'Brest Regional Clinical Cancer Dispensary, Volgograd, Russian Federation.'}, {'ForeName': 'Olga N', 'Initials': 'ON', 'LastName': 'Burdaeva', 'Affiliation': 'SBHI of Arkhangelsk Region Arkhangelsk Regional Clinical Cancer Dispensary, Arkhangelsk, Russian Federation.'}, {'ForeName': 'Sergey A', 'Initials': 'SA', 'LastName': 'Kulik', 'Affiliation': 'KLPU City Cancer Dispensary of the City of Donetsk, Donetsk, DNR, Ukraine.'}, {'ForeName': 'Chiradoni Thugappa', 'Initials': 'CT', 'LastName': 'Satheesh', 'Affiliation': 'Sri Venkateshwara Hospital, Bangalore, India.'}, {'ForeName': 'Kirti', 'Initials': 'K', 'LastName': 'Srivastava', 'Affiliation': 'King Georges Medical University, Lucknow, India.'}, {'ForeName': 'Mummaneni', 'Initials': 'M', 'LastName': 'Vikranth', 'Affiliation': 'City Cancer Center, Vijayawada, India.'}, {'ForeName': 'Fedor', 'Initials': 'F', 'LastName': 'Kryukov', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russian Federation. kryukov@biocad.ru.'}, {'ForeName': 'Anastasia N', 'Initials': 'AN', 'LastName': 'Paltusova', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Mariya S', 'Initials': 'MS', 'LastName': 'Shustova', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russian Federation.'}, {'ForeName': 'Roman A', 'Initials': 'RA', 'LastName': 'Ivanov', 'Affiliation': 'JSC BIOCAD, Saint Petersburg, Russian Federation.'}]",BMC cancer,['10.1186/s12885-020-07247-9']
2746,32819312,Effectiveness of community-based folate-oriented tertiary interventions on incidence of fetus and birth defects: a protocol for a single-blind cluster randomized controlled trial.,"BACKGROUND


Birth defects are the main cause of fetal death, infant mortality and morbidity worldwide. However, the etiology of birth defects remains largely unknown. Maternal folate status during periconception plays an important role in organogenesis and folic acid supplement reduces the risk of neural tube defects, congenital heart diseases, and several other birth defects. This trial seeks to evaluate the effectiveness of folate-oriented tertiary interventions during periconception on the incidence of fetus and birth defects.
METHODS


This is a single-blind, two-arm cluster randomized controlled trial in Shanghai, China. Eligible women from 22 clusters are recruited at pre-pregnancy physical examinations clinical settings. Compared to the routine perinatal care group (control arm), folate-oriented tertiary interventions will be provided to the intervention arm. The core interventions consist of assessments of folate status and metabolism, folate intake guidance, and re-evaluation of folate status to ensure red blood cell folate level above 400 ng/ml (906 nmol/L) before pregnancy. Screening and consulting of fetus and birth defects, and treatments of birth defects during pregnancy and afterward will be provided to both arms. The primary outcome is a composite incidence of fetus defects, stillbirth, and neonatal birth defects identified from the confirmation of pregnancy to 28 days after birth. Secondary outcomes include maternal and offspring adverse complications and cost-effectiveness of folate-oriented tertiary interventions. This protocol adheres to the SPIRIT Checklist.
DISCUSSION


To achieve the recommended folate status before or during pregnancy is still a challenge worldwide. This community-based cluster-randomized controlled intervention trial will evaluate the effectiveness of a package of interventions aiming at achieving recommended maternal folate status covering pre- and during pregnancy in reducing fetus and birth defects. Our study has the potential to improve the community-based practice of reducing modifiable risk factors of disease and improving primary prevention of the defects in China. The procedures would formulate the policy on folic acid supplementation during periconception against birth defects in primary care settings.
TRIAL REGISTRATION


Clinical Trial Registry, NCT03725878 . Prospectively registered on 31 October 2018.",2020,"Compared to the routine perinatal care group (control arm), folate-oriented tertiary interventions will be provided to the intervention arm.","['Eligible women from 22 clusters are recruited at pre-pregnancy physical examinations clinical settings', 'Prospectively registered on 31 October 2018']","['routine perinatal care group (control arm), folate-oriented tertiary interventions', 'folate-oriented tertiary interventions', 'community-based folate-oriented tertiary interventions', 'folic acid supplementation']","['composite incidence of fetus defects, stillbirth, and neonatal birth defects identified from the confirmation of pregnancy to 28\u2009days after birth', 'incidence of fetus and birth defects', 'maternal and offspring adverse complications and cost-effectiveness of folate-oriented tertiary interventions']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0242963', 'cui_str': 'Perinatal Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0549169', 'cui_str': 'Confirmation of pregnancy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.104388,"Compared to the routine perinatal care group (control arm), folate-oriented tertiary interventions will be provided to the intervention arm.","[{'ForeName': 'Mengru', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Xiaotian', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Dingmei', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Mi', 'Initials': 'M', 'LastName': 'Ji', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Yalan', 'Initials': 'Y', 'LastName': 'Dou', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sheng', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.""}, {'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China. yanwl@fudan.edu.cn.""}, {'ForeName': 'Guoying', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China. gyhuang@shmu.edu.cn.""}]",BMC pregnancy and childbirth,['10.1186/s12884-020-03154-w']
2747,32819404,Evaluation of the analgesic effect of vertebral cancellous bone infiltration anaesthesia during vertebroplasty.,"OBJECTIVE


To evaluate the analgesic effect of vertebral cancellous bone infiltration anaesthesia during percutaneous vertebroplasty (PVP).
METHODS


Patients treated with vertebral cancellous bone infiltration anaesthesia (intervention group) or local anaesthesia alone (control group) during PVP at our institution during 2016-2018 were reviewed. The visual analogue scale (VAS) score before the operation, during establishment of the puncture channel, during pressure changes in the vertebral body (e.g., when removing or inserting pushers or needle cores), during bone cement injection, immediately after the operation, and at 2 h and 1 day postoperatively were compared between the groups. The patient's satisfaction with the operation was recorded and compared between groups.
RESULTS


A total of 112 patients were enrolled (59 cases in the intervention group and 53 cases in the control group). There was no difference in the VAS score between the groups before the operation or during establishment of the intraoperative puncture channel (P > 0.05). The VAS score in the intervention group was significantly lower than that in the control group during pressure changes in the vertebral body (removal or insertion of puncture needle cores or pushers) and bone cement injection (P < 0.05). Immediately after the operation and at 2 h postoperatively, the pain in the intervention group was also significantly lower than that in the control group (P < 0.05), but there was no significant difference between the groups at 1 day postoperatively (P > 0.05). The patient satisfaction rate was 88% (52/59) in the intervention group and 67% (35/53) in the control group (P < 0.05).
CONCLUSIONS


Vertebral cancellous bone infiltration anaesthesia may effectively relieve intraoperative pain and improve the surgical experience of patients without affecting the clinical effect of surgery.",2020,The VAS score in the intervention group was significantly lower than that in the control group during pressure changes in the vertebral body (removal or insertion of puncture needle cores or pushers) and bone cement injection (P < 0.05).,"['at our institution during 2016-2018 were reviewed', '112 patients were enrolled (59 cases in the intervention group and 53 cases in the control group', 'Patients treated with vertebral cancellous bone infiltration anaesthesia (intervention group) or']","['vertebral cancellous bone infiltration anaesthesia during percutaneous vertebroplasty (PVP', 'vertebral cancellous bone infiltration anaesthesia', 'local anaesthesia alone (control group) during PVP']","['VAS score', 'patient satisfaction rate', 'intraoperative pain', 'pain', 'visual analogue scale (VAS) score']","[{'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0234945', 'cui_str': 'Infiltration anaesthesia'}]","[{'cui': 'C0549207', 'cui_str': 'Bone structure of spine'}, {'cui': 'C0222660', 'cui_str': 'Trabecular substance of bone'}, {'cui': 'C0234945', 'cui_str': 'Infiltration anaesthesia'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0032856', 'cui_str': 'Povidone'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",112.0,0.0189299,The VAS score in the intervention group was significantly lower than that in the control group during pressure changes in the vertebral body (removal or insertion of puncture needle cores or pushers) and bone cement injection (P < 0.05).,"[{'ForeName': 'Zhaofei', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedic Surgery, Guangzhou Hospital of Integrated Traditional and Western Medicine, 87 Yingbin Road, Huadu District, Guangzhou, 510800, Guangdong, China. hanyangzzf@163.com.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Jiao', 'Affiliation': 'Department of Orthopedic Surgery, Guangzhou Hospital of Integrated Traditional and Western Medicine, 87 Yingbin Road, Huadu District, Guangzhou, 510800, Guangdong, China.'}, {'ForeName': 'Yonghui', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Orthopedic Surgery, Guangzhou Hospital of Integrated Traditional and Western Medicine, 87 Yingbin Road, Huadu District, Guangzhou, 510800, Guangdong, China.'}, {'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': 'Department of Orthopedic Surgery, Guangzhou Hospital of Integrated Traditional and Western Medicine, 87 Yingbin Road, Huadu District, Guangzhou, 510800, Guangdong, China.'}, {'ForeName': 'Fengwei', 'Initials': 'F', 'LastName': 'Qin', 'Affiliation': 'Department of Orthopedic Surgery, Guangzhou Hospital of Integrated Traditional and Western Medicine, 87 Yingbin Road, Huadu District, Guangzhou, 510800, Guangdong, China.'}, {'ForeName': 'Sineng', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Orthopedic Surgery, Guangzhou Hospital of Integrated Traditional and Western Medicine, 87 Yingbin Road, Huadu District, Guangzhou, 510800, Guangdong, China.'}, {'ForeName': 'Donghua', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Orthopedic Surgery, Guangzhou Hospital of Integrated Traditional and Western Medicine, 87 Yingbin Road, Huadu District, Guangzhou, 510800, Guangdong, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Department of Orthopedic Surgery, Guangzhou Hospital of Integrated Traditional and Western Medicine, 87 Yingbin Road, Huadu District, Guangzhou, 510800, Guangdong, China.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-020-01872-7']
2748,32819412,Virtual reality-based action observation facilitates the acquisition of body-powered prosthetic control skills.,"BACKGROUND


Regular body-powered (BP) prosthesis training facilitates the acquisition of skills through repeated practice but requires adequate time and motivation. Therefore, auxiliary tools such as indirect training may improve the training experience and speed of skill acquisition. In this study, we examined the effects of action observation (AO) using virtual reality (VR) as an auxiliary tool. We used two modalities during AO: three-dimensional (3D) VR and two-dimensional (2D) computer tablet devices (Tablet). Each modality was tested from first- and third-person perspectives.
METHODS


We studied 40 healthy right-handed participants wearing a BP prosthesis simulator on their non-dominant hands. The participants were divided into five groups based on combinations of the different modalities and perspectives: first-person perspective on VR (VR1), third-person perspective on VR (VR3), first-person perspective on a tablet (Tablet1), third-person perspective on a tablet (Tablet3), and a control group (Control). The intervention groups observed and imitated the video image of prosthesis operation for 10 min in each of two sessions. We evaluated the level of immersion during AO using the visual analogue scale. Prosthetic control skills were evaluated using the Box and Block Test (BBT) and a bowknot task (BKT).
RESULTS


In the BBT, there were no significant differences in the amount of change in the skills between the five groups. In contrast, the relative changes in the BKT prosthetic control skills in VR1 (p < 0.001, d = 3.09) and VR3 (p < 0.001, d = 2.16) were significantly higher than those in the control group. Additionally, the immersion scores of VR1 (p < 0.05, d = 1.45) and VR3 (p < 0.05, d = 1.18) were higher than those of Tablet3. There was a significant negative correlation between the immersion scores and the relative change in the BKT scores (Spearman's r s  = - 0.47, p < 0.01).
CONCLUSIONS


Using the BKT of bilateral manual dexterity, VR-based AO significantly improved short-term prosthetic control acquisition. Additionally, it appeared that the higher the immersion score was, the shorter the execution time of the BKT task. Our findings suggest that VR-based AO training may be effective in acquiring bilateral BP prosthetic control, which requires more 3D-based operation.",2020,"In contrast, the relative changes in the BKT prosthetic control skills in VR1 (p < 0.001, d = 3.09) and VR3 (p < 0.001, d = 2.16) were significantly higher than those in the control group.",['40 healthy right-handed participants wearing a BP prosthesis simulator on their non-dominant hands'],"['person perspective on VR (VR1), third-person perspective on VR (VR3), first-person perspective on a tablet (Tablet1), third-person perspective on a tablet (Tablet3), and a control group (Control', 'Regular body-powered (BP) prosthesis training', 'AO: three-dimensional (3D) VR and two-dimensional (2D) computer tablet devices (Tablet', 'Virtual reality-based action observation', 'VR-based AO training', 'action observation (AO) using virtual reality (VR']","['Box and Block Test (BBT) and a bowknot task (BKT', 'execution time of the BKT task', 'immersion scores of VR1', 'VR3', 'BKT scores']","[{'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0449722', 'cui_str': 'Dominant hand'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",40.0,0.0170855,"In contrast, the relative changes in the BKT prosthetic control skills in VR1 (p < 0.001, d = 3.09) and VR3 (p < 0.001, d = 2.16) were significantly higher than those in the control group.","[{'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Yoshimura', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan. mnb328@med.kawasaki-m.ac.jp.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kurumadani', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Hirata', 'Affiliation': 'Kawasaki University of Medical Welfare, Okayama, Japan, 288 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Osaka', 'Affiliation': 'Kawasaki University of Medical Welfare, Okayama, Japan, 288 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Katsutoshi', 'Initials': 'K', 'LastName': 'Senoo', 'Affiliation': 'Kawasaki University of Medical Welfare, Okayama, Japan, 288 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Date', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Akio', 'Initials': 'A', 'LastName': 'Ueda', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Ishii', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Kinoshita', 'Affiliation': 'Kawasaki Medical School Hospital, Okayama, Japan, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Kozo', 'Initials': 'K', 'LastName': 'Hanayama', 'Affiliation': 'Kawasaki Medical School, Department of Rehabilitation Medicine, Okayama, Japan, 577 Matsushima, Kurashiki, Okayama, 701-0192, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Sunagawa', 'Affiliation': 'Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan, 1-2-3 Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00743-w']
2749,32819413,Impact of a ketogenic diet intervention during radiotherapy on body composition: III-final results of the KETOCOMP study for breast cancer patients.,"BACKGROUND


Obesity and low muscle mass are associated with worse outcomes of breast cancer patients. We conducted a controlled trial to study the impact of a ketogenic diet (KD) based on natural foods versus an unspecified standard diet (SD) on body composition in breast cancer patients undergoing radiotherapy.
METHODS


Patients with non-metastasized breast cancer were allocated to either the KD (N = 32) or the SD (N = 31) during radiotherapy. Body composition was measured weekly by bioimpedance analysis. Blood parameters and quality of life were assessed before, during, and at the end of radiotherapy.
RESULTS


A total of 29 KD and 30 SD patients completed the study. During radiotherapy, mean and median fasting BHB concentrations in the KD group were 0.72 and 0.49 mmol/l (range 0.06-4.9) which was significantly higher than those in the SD group (p < 2.2 × 10 -16 ). There was a very small and insignificant increase in body weight and fat mass in the SD group, as well as a decrease of fat free mass. In contrast, patients in the KD group lost body weight and fat free and skeletal muscle mass quickly after diet onset, which for the most part was related to water losses. The KD did not cause further substantial changes in fat free or skeletal muscle mass, but was associated with a gradual decrease of 0.4 kg body weight and fat mass per week (p < 0.0001). The KD significantly decreased free T3 levels by 0.06 pg/ml/week (p = 6.3 × 10 -5 ). Global quality of life remained stable in the SD group but increased in the KD group from a score of 66.7 to 75.0 (p = 0.20).
CONCLUSIONS


In breast cancer patients undergoing curative radiotherapy, a KD based on natural foods is feasible. After initial water losses, the KD tends to reduce body weight and fat mass while preserving fat free and skeletal muscle mass.
TRIAL REGISTRATION


ClinicalTrials.gov identifier: NCT02516501 , registered on August 06, 2015.",2020,The KD significantly decreased free T3 levels by 0.06 pg/ml/week (p = 6.3 × 10 -5 ).,"['breast cancer patients undergoing', 'Patients with non-metastasized breast cancer', 'breast cancer patients', 'breast cancer patients undergoing radiotherapy', 'A total of 29 KD and 30 SD patients completed the study']","['ketogenic diet intervention', 'ketogenic diet (KD) based on natural foods versus an unspecified standard diet (SD', 'radiotherapy', 'curative radiotherapy']","['fat free or skeletal muscle mass', 'Body composition', 'body composition', 'Blood parameters and quality of life', 'free T3 levels', 'body weight and fat free and skeletal muscle mass', 'mean and median fasting BHB concentrations', 'Global quality of life', 'body weight and fat mass']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0519160', 'cui_str': 'Triiodothyronine, free measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0482809,The KD significantly decreased free T3 levels by 0.06 pg/ml/week (p = 6.3 × 10 -5 ).,"[{'ForeName': 'Rainer J', 'Initials': 'RJ', 'LastName': 'Klement', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany. rainer_klement@gmx.de.'}, {'ForeName': 'Colin E', 'Initials': 'CE', 'LastName': 'Champ', 'Affiliation': 'Department of Radiation Oncology, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Kämmerer', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Hospital of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Petra S', 'Initials': 'PS', 'LastName': 'Koebrunner', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany.'}, {'ForeName': 'Kelley', 'Initials': 'K', 'LastName': 'Krage', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Schäfer', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weigel', 'Affiliation': 'Department of Obstetrics and Gynaecology, Leopoldina Hospital, Breast Cancer Centre, Schweinfurt, Germany.'}, {'ForeName': 'Reinhart A', 'Initials': 'RA', 'LastName': 'Sweeney', 'Affiliation': 'Department of Radiation Oncology, Leopoldina Hospital, Robert-Koch-Straße 10, 97422, Schweinfurt, Germany.'}]",Breast cancer research : BCR,['10.1186/s13058-020-01331-5']
2750,32819429,"The effect of on-site CT-derived fractional flow reserve on the management of decision making for patients with stable chest pain (TARGET trial): objective, rationale, and design.","BACKGROUND


The diagnostic accuracy of CT-derived fractional flow reserve (CT-FFR) in clinical application has been well validated. This advanced technology focus on evaluating anatomical stenosis and functional ischemia simultaneously. However, the effect of CT-FFR on the management of decision making has not been fully evaluated in randomized controlled design.
METHOD/DESIGN


TARGET study is a pragmatic, multicenter, prospective, open-label, and randomized controlled trial evaluating the effect of a CCTA/CT-FFR strategy (group A) versus usual care (group B) on intermediate-to-high risk patients with suspected CAD who undergo clinically indicated diagnostic evaluation. A total sample size of 1216 subjects will be enrolled and followed up for 12 months. This study will be performed in 6 Chinese hospitals, and the primary endpoint is the planned ICA without significant obstructive CAD within 90 days. The secondary endpoints include MACE, quality of life, medical expenditure, and cumulative radiation exposure during 1-year follow-up.
DISCUSSION


The study will provide information to patients, health care providers, and other stakeholders in China about which strategy could be more effective in the management of intermediate-to-high risk patients with suspect CAD.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03901326 . Registered on 3 April 2019.",2020,"BACKGROUND


The diagnostic accuracy of CT-derived fractional flow reserve (CT-FFR) in clinical application has been well validated.","['risk patients with suspected CAD who undergo clinically indicated diagnostic evaluation', '6 Chinese hospitals', 'A total sample size of 1216 subjects will be enrolled and followed up for 12\u2009months', 'patients with stable chest pain (TARGET trial']","['CCTA/CT-FFR strategy (group A) versus usual care', 'CT-FFR', 'site CT-derived fractional flow reserve', 'CT-derived fractional flow reserve (CT-FFR']","['MACE, quality of life, medical expenditure, and cumulative radiation exposure during 1-year follow-up']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",1216.0,0.121725,"BACKGROUND


The diagnostic accuracy of CT-derived fractional flow reserve (CT-FFR) in clinical application has been well validated.","[{'ForeName': 'Junjie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of Cardiology, Chinese PLA General Hospital, 28 Fuxing Rd, Haidian District, Beijing, 100853, People's Republic of China.""}, {'ForeName': 'Dongkai', 'Initials': 'D', 'LastName': 'Shan', 'Affiliation': ""Department of Cardiology, Chinese PLA General Hospital, 28 Fuxing Rd, Haidian District, Beijing, 100853, People's Republic of China.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Dong', 'Affiliation': ""Department of Cardiology, Qilu Hospital of Shandong University, Jinan, People's Republic of China.""}, {'ForeName': 'Zhiqiang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Anzhen Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': ""Department of Cardiology, First Affiliated Hospital of Xinjiang Medical University, Urumchi, People's Republic of China.""}, {'ForeName': 'Xinyang', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': ""Department of Cardiology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, People's Republic of China.""}, {'ForeName': 'Hesong', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': ""Department of Cardiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China.""}, {'ForeName': 'Yundai', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Cardiology, Chinese PLA General Hospital, 28 Fuxing Rd, Haidian District, Beijing, 100853, People's Republic of China. cyundai@vip.163.com.""}]",Trials,['10.1186/s13063-020-04649-9']
2751,32817595,Multicenter Clinical Trials Analyzing Efficacy and Safety of Topical Cortex Phellodendri Compound Fluid in Treatment of Diabetic Foot Ulcers.,"BACKGROUND The aim of this study was to analyze the clinical application of cortex phellodendri compound fluid (CPCF) in the treatment of diabetic foot ulcers. MATERIAL AND METHODS From January 2012 to December 2015, a total of 720 cases of diabetic foot ulcers (DFU) were randomly assigned into an experimental group (n=540) that was treated by CPCF and a control group (n=180) that was treated by a Kangfuxin solution (KFS). After 4 weeks of treatment, their ulcer area, serum growth factor, clinical total effective rate, and incidence of adverse events were assessed. RESULTS There were 720 patients who completed the trial. The experimental group was superior to the control group in reducing ulcer area, increasing growth factor content, and total effective rate (P<0.05). There was no significant difference in the adverse events rates between the 2 groups. CONCLUSIONS CPCF external treatment of diabetic foot ulcer can promote ulcer healing and increase the concentration of growth factors, and it is safe and reliable.",2020,"The experimental group was superior to the control group in reducing ulcer area, increasing growth factor content, and total effective rate (P<0.05).","['720 patients who completed the trial', 'Diabetic Foot Ulcers', 'From January 2012 to December 2015, a total of 720 cases of diabetic foot ulcers (DFU', 'diabetic foot ulcers']","['CPCF external', 'Topical Cortex Phellodendri Compound Fluid', 'CPCF and a control group (n=180) that was treated by a Kangfuxin solution (KFS', 'cortex phellodendri compound fluid (CPCF']","['ulcer area, increasing growth factor content, and total effective rate', 'ulcer area, serum growth factor, clinical total effective rate, and incidence of adverse events', 'adverse events rates']","[{'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C4548560', 'cui_str': 'kangfuxin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0333957', 'cui_str': 'Growth acceleration'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0248672,"The experimental group was superior to the control group in reducing ulcer area, increasing growth factor content, and total effective rate (P<0.05).","[{'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Peripheral Vascular Surgery, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (mainland).'}, {'ForeName': 'Youshan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Peripheral Vascular Surgery, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (mainland).'}, {'ForeName': 'Yuqing', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Peripheral Vascular Surgery, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (mainland).'}, {'ForeName': 'Tianyi', 'Initials': 'T', 'LastName': 'Huang', 'Affiliation': 'Department of Peripheral Vascular Surgery, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (mainland).'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Peripheral Vascular Surgery, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.923424']
2752,32817632,Evaluation of the effectiveness of topical repellent distributed by village health volunteer networks against Plasmodium spp. infection in Myanmar: A stepped-wedge cluster randomised trial.,"BACKGROUND


The World Health Organization has yet to endorse deployment of topical repellents for malaria prevention as part of public health campaigns. We aimed to quantify the effectiveness of repellent distributed by the village health volunteer (VHV) network in the Greater Mekong Subregion (GMS) in reducing malaria in order to advance regional malaria elimination.
METHODS AND FINDINGS


Between April 2015 and June 2016, a 15-month stepped-wedge cluster randomised trial was conducted in 116 villages in Myanmar (stepped monthly in blocks) to test the effectiveness of 12% N,N-diethylbenzamide w/w cream distributed by VHVs, on Plasmodium spp. infection. The median age of participants was 18 years, approximately half were female, and the majority were either village residents (46%) or forest dwellers (40%). No adverse events were reported during the study. Generalised linear mixed modelling estimated the effect of repellent on infection detected by rapid diagnostic test (RDT) (primary outcome) and polymerase chain reaction (PCR) (secondary outcome). Overall Plasmodium infection detected by RDT was low (0.16%; 50/32,194), but infection detected by PCR was higher (3%; 419/13,157). There was no significant protection against RDT-detectable infection (adjusted odds ratio [AOR] = 0.25, 95% CI 0.004-15.2, p = 0.512). In Plasmodium-species-specific analyses, repellent protected against PCR-detectable P. falciparum (adjusted relative risk ratio [ARRR] = 0.67, 95% CI 0.47-0.95, p = 0.026), but not P. vivax infection (ARRR = 1.41, 95% CI 0.80-2.47, p = 0.233). Repellent effects were similar when delayed effects were modelled, across risk groups, and regardless of village-level and temporal heterogeneity in malaria prevalence. The incremental cost-effectiveness ratio was US$256 per PCR-detectable infection averted. Study limitations were a lower than expected Plasmodium spp. infection rate and potential geographic dilution of the intervention.
CONCLUSIONS


In this study, we observed apparent protection against new infections associated with the large-scale distribution of repellent by VHVs. Incorporation of repellent into national strategies, particularly in areas where bed nets are less effective, may contribute to the interruption of malaria transmission. Further studies are warranted across different transmission settings and populations, from the GMS and beyond, to inform WHO public health policy on the deployment of topical repellents for malaria prevention.
TRIAL REGISTRATION


Australian and New Zealand Clinical Trials Registry (ACTRN12616001434482).",2020,"In Plasmodium-species-specific analyses, repellent protected against PCR-detectable P. falciparum (adjusted relative risk ratio [ARRR] = 0.67, 95% CI 0.47-0.95, p = 0.026), but not P. vivax infection (ARRR = 1.41, 95% CI 0.80-2.47, p = 0.233).","['infection in Myanmar', 'Between April 2015 and June 2016, a 15-month stepped-wedge cluster randomised trial was conducted in 116 villages in Myanmar (stepped monthly in blocks', 'village health volunteer networks against\xa0Plasmodium spp', 'The median age of participants was 18 years, approximately half were female, and the majority were either village residents (46%) or forest dwellers (40']","['diethylbenzamide w/w cream distributed by VHVs, on Plasmodium spp', 'village health volunteer (VHV) network in the Greater Mekong Subregion (GMS']","['infection rate and potential geographic dilution', 'protection against RDT-detectable infection', 'rapid diagnostic test (RDT) (primary outcome) and polymerase chain reaction (PCR', 'incremental cost-effectiveness ratio', 'adverse events', 'Overall Plasmodium infection']","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0006416', 'cui_str': 'Burma'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0439639', 'cui_str': 'Wedge'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0032148', 'cui_str': 'Plasmodium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0086312', 'cui_str': 'Forest'}]","[{'cui': 'C2919747', 'cui_str': 'w/w'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0032148', 'cui_str': 'Plasmodium'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205393', 'cui_str': 'Most'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}]",,0.250486,"In Plasmodium-species-specific analyses, repellent protected against PCR-detectable P. falciparum (adjusted relative risk ratio [ARRR] = 0.67, 95% CI 0.47-0.95, p = 0.026), but not P. vivax infection (ARRR = 1.41, 95% CI 0.80-2.47, p = 0.233).","[{'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Agius', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Cutts', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Win', 'Initials': 'W', 'LastName': 'Han Oo', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Thi', 'Affiliation': 'Department of Public Health, Myanmar Ministry of Health and Sports, Nay Pyi Taw, Myanmar.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': ""O'Flaherty"", 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Kyaw', 'Initials': 'K', 'LastName': 'Zayar Aung', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Htin', 'Initials': 'H', 'LastName': 'Kyaw Thu', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Poe', 'Initials': 'P', 'LastName': 'Poe Aung', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Myat', 'Initials': 'M', 'LastName': 'Mon Thein', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Nyi', 'Initials': 'N', 'LastName': 'Nyi Zaw', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Wai', 'Initials': 'W', 'LastName': 'Yan Min Htay', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Aung', 'Initials': 'A', 'LastName': 'Paing Soe', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Razook', 'Affiliation': 'Population Health and Immunity Division, Walter and Eliza Hall Institute of Medical Research, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alyssa E', 'Initials': 'AE', 'LastName': 'Barry', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Win', 'Initials': 'W', 'LastName': 'Htike', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Devine', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Simpson', 'Affiliation': 'Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Brendan S', 'Initials': 'BS', 'LastName': 'Crabb', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Beeson', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Naanki', 'Initials': 'N', 'LastName': 'Pasricha', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}, {'ForeName': 'Freya J I', 'Initials': 'FJI', 'LastName': 'Fowkes', 'Affiliation': 'Burnet Institute, Victoria, Australia, and Yangon, Myanmar.'}]",PLoS medicine,['10.1371/journal.pmed.1003177']
2753,32817638,Correction: A randomized controlled trial of nitrate supplementation in well-trained middle and older-aged adults.,[This corrects the article DOI: 10.1371/journal.pone.0235047.].,2020,[This corrects the article DOI: 10.1371/journal.pone.0235047.].,['well-trained middle and older-aged adults'],['nitrate supplementation'],[],"[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]",[],,0.0815607,[This corrects the article DOI: 10.1371/journal.pone.0235047.].,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Berry', 'Affiliation': ''}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Miller', 'Affiliation': ''}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Kim-Shapiro', 'Affiliation': ''}, {'ForeName': 'Macie S', 'Initials': 'MS', 'LastName': 'Fletcher', 'Affiliation': ''}, {'ForeName': 'Caleb G', 'Initials': 'CG', 'LastName': 'Jones', 'Affiliation': ''}, {'ForeName': 'Zachary D', 'Initials': 'ZD', 'LastName': 'Gauthier', 'Affiliation': ''}, {'ForeName': 'Summer L', 'Initials': 'SL', 'LastName': 'Collins', 'Affiliation': ''}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': ''}, {'ForeName': 'Timothy M', 'Initials': 'TM', 'LastName': 'Heinrich', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0238271']
2754,32816504,Moderators of treatment response to an intervention for nonsuicidal self-injury in young adults.,"Objective:  Despite the prevalence and impact of nonsuicidal self-injury (NSSI), there are few treatments developed to treat the behavior specifically, and little is known about moderators of treatment response. The Treatment for Self-Injurious Behaviors (T-SIB), a brief, behavioral intervention, was developed to treat NSSI in young adults; a previous pilot randomized controlled trial (RCT) comparing T-SIB with treatment as usual (TAU) provided support for the intervention. This study examined demographic, clinical, and NSSI-related predictors of treatment outcome in the pilot RCT for T-SIB.  Method:  Young adults (N = 33) were randomized to receive T-SIB or treatment as usual; all participants were included in intent-to-treat analyses. The primary outcome of NSSI behaviors was assessed at baseline, posttreatment (9 weeks), and 3-month follow up, and potential moderators were assessed at baseline.  Results:  Greater lifetime and last year NSSI frequency was associated with fewer NSSI behaviors at posttreatment and follow up among participants in T-SIB. Anxious symptoms also moderated treatment outcomes, but other demographic and clinical variables did not.  Conclusion:  Previous research has shown that T-SIB is more effective than TAU overall; the current study suggests that T-SIB may be effective for individuals with more frequent NSSI and those with elevated anxiety. A larger evaluation of T-SIB is supported. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Greater lifetime and last year NSSI frequency was associated with fewer NSSI behaviors at posttreatment and follow up among participants in T-SIB.,"['Young adults (N = 33', 'young adults', 'nonsuicidal self-injury in young adults']",[],"['Greater lifetime and last year NSSI frequency', 'NSSI behaviors', 'Anxious symptoms']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}]",[],"[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",33.0,0.159824,Greater lifetime and last year NSSI frequency was associated with fewer NSSI behaviors at posttreatment and follow up among participants in T-SIB.,"[{'ForeName': 'Margaret S', 'Initials': 'MS', 'LastName': 'Andover', 'Affiliation': 'Department of Psychology, Fordham University.'}, {'ForeName': 'Heather T', 'Initials': 'HT', 'LastName': 'Schatten', 'Affiliation': 'Psychosocial Research Program, Butler Hospital.'}, {'ForeName': 'Caroline S', 'Initials': 'CS', 'LastName': 'Holman', 'Affiliation': 'Providence Veterans Affairs Medical Center.'}, {'ForeName': 'Ivan W', 'Initials': 'IW', 'LastName': 'Miller', 'Affiliation': 'Psychosocial Research Program, Butler Hospital.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000603']
2755,32819447,"Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: subgroup analysis of CASTOR based on cytogenetic risk.","BACKGROUND


Multiple myeloma (MM) patients with high cytogenetic risk have poor outcomes. In CASTOR, daratumumab plus bortezomib/dexamethasone (D-Vd) prolonged progression-free survival (PFS) versus bortezomib/dexamethasone (Vd) alone and exhibited tolerability in patients with relapsed or refractory MM (RRMM).
METHODS


This subgroup analysis evaluated D-Vd versus Vd in CASTOR based on cytogenetic risk, determined using fluorescence in situ hybridization and/or karyotype testing performed locally. High-risk patients had t(4;14), t(14;16), and/or del17p abnormalities. Minimal residual disease (MRD; 10 -5  sensitivity threshold) was assessed via the clonoSEQ® assay V2.0. Of the 498 patients randomized, 40 (16%) in the D-Vd group and 35 (14%) in the Vd group were categorized as high risk.
RESULTS


After a median follow-up of 40.0 months, D-Vd prolonged median PFS versus Vd in patients with standard (16.6 vs 6.6 months; HR, 0.26; 95% CI, 0.19-0.37; P < 0.0001) and high (12.6 vs 6.2 months; HR, 0.41; 95% CI, 0.21-0.83; P = 0.0106) cytogenetic risk. D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk. The safety profile was consistent with the overall population of CASTOR.
CONCLUSION


These updated data reinforce the effectiveness and tolerability of daratumumab-based regimens for RRMM, regardless of cytogenetic risk status.
TRIAL REGISTRATION


ClinicalTrials.gov, NCT02136134 . Registered 12 May 2014.",2020,"D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk.","['patients with relapsed or refractory MM (RRMM', 'Multiple myeloma (MM) patients with high cytogenetic risk']","['Daratumumab, bortezomib, and dexamethasone', 'bortezomib/dexamethasone (Vd) alone', 'bortezomib/dexamethasone']","['progression-free survival (PFS', 'higher rates of MRD negativity and sustained MRD negativity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetics'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242596', 'cui_str': 'Minimal residual disease'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}]",498.0,0.142329,"D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk.","[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Weisel', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section of Pneumology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. k.weisel@uke.de.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Lentzsch', 'Affiliation': 'Division of Hematology/Oncology, Columbia University, New York, NY, USA.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Avet-Loiseau', 'Affiliation': 'Unite de Genomique du Myelome, CHU Rangueil, Toulouse, France.'}, {'ForeName': 'Tomer M', 'Initials': 'TM', 'LastName': 'Mark', 'Affiliation': 'Department of Medicine, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Spicka', 'Affiliation': 'Clinical Department of Haematology, 1st Medical Department, Charles University in Prague, Prague, Czech Republic.'}, {'ForeName': 'Tamas', 'Initials': 'T', 'LastName': 'Masszi', 'Affiliation': 'László Hospital, 3rd Department of Internal Medicine, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Lauri', 'Affiliation': 'Department of Hematology, Sunderbyn Hospital, Luleå, Sweden.'}, {'ForeName': 'Mark-David', 'Initials': 'MD', 'LastName': 'Levin', 'Affiliation': 'Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, The Netherlands.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Bosi', 'Affiliation': 'Department of Hematology, Careggi Hospital and University of Florence, Firenze, Italy.'}, {'ForeName': 'Vania', 'Initials': 'V', 'LastName': 'Hungria', 'Affiliation': 'Irmandade Da Santa Casa De Misericordia De São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': '""Seràgnoli"" Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Je-Jung', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Hwasun, Jeollanamdo, South Korea.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Nooka', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Quach', 'Affiliation': ""University of Melbourne, St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Munder', 'Affiliation': 'University Medical Center of the Johannes Gutenberg University, Third Department of Medicine, Mainz, Germany.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Lee', 'Affiliation': 'Royal Adelaide Hospital, North Terrace, Adelaide, Australia.'}, {'ForeName': 'Wolney', 'Initials': 'W', 'LastName': 'Barreto', 'Affiliation': 'University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corradini', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, University of Milan, Milan, Italy.'}, {'ForeName': 'Chang-Ki', 'Initials': 'CK', 'LastName': 'Min', 'Affiliation': ""Seoul St. Mary's Hospital, Seoul, South Korea.""}, {'ForeName': 'Asher A', 'Initials': 'AA', 'LastName': 'Chanan-Khan', 'Affiliation': 'Mayo Clinic Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Noemi', 'Initials': 'N', 'LastName': 'Horvath', 'Affiliation': 'Royal Adelaide Hospital, North Terrace, Adelaide, Australia.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Capra', 'Affiliation': 'Instituto do Cancer-Hospital Mae de Deus, Porto Alegre, Brazil.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Ankara University, Ankara, Turkey.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Ovilla', 'Affiliation': 'Hospital Angeles Lomas, Naucalpan de Juárez y alrededores, Mexico.'}, {'ForeName': 'Jae-Cheol', 'Initials': 'JC', 'LastName': 'Jo', 'Affiliation': 'Ulsan University Hospital, Ulsan, South Korea.'}, {'ForeName': 'Ho-Jin', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Pusan National University Hospital, Busan, South Korea.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Sonneveld', 'Affiliation': 'Erasmus MC, Rotterdam, The Netherlands.'}, {'ForeName': 'Tineke', 'Initials': 'T', 'LastName': 'Casneuf', 'Affiliation': 'Janssen Research & Development, LLC, Beerse, Belgium.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'DeAngelis', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Himal', 'Initials': 'H', 'LastName': 'Amin', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Scientific Affairs, Horsham, PA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Kobos', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Maria-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'University Hospital of Salamanca/IBSAL/Cancer Research Center-IBMCC (USAL-CSIC), Salamanca, Spain.'}]",Journal of hematology & oncology,['10.1186/s13045-020-00948-5']
2756,32819461,Sex Differences in All-Cause Mortality in the Decade Following Complex Coronary Revascularization.,"BACKGROUND


The poorer prognosis of coronary artery disease in females compared with males is related mainly to differences in baseline characteristics. In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, the effect of treatment with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting surgery (CABG) on mortality at 5 years differed significantly between females and males; however, the optimal revascularization beyond 5 years according to sex has not been evaluated.
OBJECTIVES


The aim of this study was to investigate the impact of sex on mortality and sex-treatment interaction at 10 years.
METHODS


The SYNTAXES (SYNTAX Extended Survival) study evaluated vital status up to 10 years in 1,800 patients with de novo 3-vessel and/or left main coronary artery disease randomized to treatment with PCI or CABG in the SYNTAX trial. All-cause death at 10 years was separately evaluated in female and male patients with complex coronary artery disease.
RESULTS


Of 1,800 patients, 402 (22.3%) were female and 1,398 (77.7%) were males. Females had a higher 10-year mortality rate compared with males (32.8% vs. 24.7%; log-rank p = 0.002), but female sex was not an independent predictor of mortality (adjusted hazard ratio: 1.02; 95% confidence interval: 0.76 to 1.36). Mortality at 10 years tended to be lower after CABG than after PCI, with a similar treatment effect for female and male patients (adjusted hazard ratio for females: 0.90 [95% confidence interval: 0.54 to 1.51]; adjusted hazard ratio for males: 0.76 [95% confidence interval: 0.56 to 1.02]; p for interaction = 0.952).
CONCLUSIONS


Female sex was not an independent predictor of mortality at 10 years in patients with complex coronary artery disease. The interaction between sex and treatment with PCI or CABG that was observed at 5 years was no longer present at 10 years. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES], NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX], NCT00114972).",2020,"Mortality at 10 years tended to be lower after CABG than after PCI, with a similar treatment effect for female and male patients (adjusted hazard ratio for females: 0.90 [95% confidence interval: 0.54 to 1.51]; adjusted hazard ratio for males: 0.76","['Of 1,800 patients, 402 (22.3%) were female and 1,398 (77.7%) were males', 'patients with complex coronary artery disease', 'female and male patients with complex coronary artery disease', '1,800 patients with de novo 3-vessel and/or left main coronary artery disease randomized to treatment with PCI or CABG in the SYNTAX trial']","['TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery', 'percutaneous coronary intervention (PCI', 'coronary artery bypass grafting surgery (CABG']","['10-year mortality rate', 'mortality', 'Mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C1299433', 'cui_str': 'Left main coronary artery disease'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0330199', 'cui_str': 'Taxus'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1800.0,0.120703,"Mortality at 10 years tended to be lower after CABG than after PCI, with a similar treatment effect for female and male patients (adjusted hazard ratio for females: 0.90 [95% confidence interval: 0.54 to 1.51]; adjusted hazard ratio for males: 0.76","[{'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Department of Cardiology, National University of Ireland, Galway, Galway, Ireland.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'van Klaveren', 'Affiliation': 'Department of Public Health, Center for Medical Decision Making, Erasmus MC, Rotterdam, the Netherlands; Predictive Analytics and Comparative Effectiveness Center, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway, Galway, Ireland; Department of Cardiology, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'Department of Cardiology, Royal Blackburn Hospital, Blackburn, United Kingdom.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Department of Cardiology, National University of Ireland, Galway, Galway, Ireland.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Department of Cardiology, National University of Ireland, Galway, Galway, Ireland.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway, Galway, Ireland; Department of Cardiology, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mack', 'Affiliation': 'Department of Cardiothoracic Surgery, Baylor Scott and White Healthcare, Dallas, Texas.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Holmes', 'Affiliation': 'Department of Cardiovascular Diseases and Internal Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Département of Cardiologie, Hôpital privé Jacques Cartier, Générale de Santé Massy, France.'}, {'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Head', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Daniel J F M', 'Initials': 'DJFM', 'LastName': 'Thuijs', 'Affiliation': 'Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway, Galway, Ireland.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Noack', 'Affiliation': 'University Department of Cardiac Surgery, Heart Centre Leipzig, Leipzig, Germany.'}, {'ForeName': 'Friedrich W', 'Initials': 'FW', 'LastName': 'Mohr', 'Affiliation': 'University Department of Cardiac Surgery, Heart Centre Leipzig, Leipzig, Germany.'}, {'ForeName': 'Piroze M', 'Initials': 'PM', 'LastName': 'Davierwala', 'Affiliation': 'University Department of Cardiac Surgery, Heart Centre Leipzig, Leipzig, Germany.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway, Galway, Ireland; National Heart and Lung Institute, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.06.066']
2757,32819465,Pulmonary Artery Denervation for Patients With Residual Pulmonary Hypertension After Pulmonary Endarterectomy.,"BACKGROUND


Pulmonary artery denervation (PADN) procedure has not been applied to patients with residual chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary endarterectomy (PEA).
OBJECTIVES


This study sought to assess the safety and efficacy of PADN using remote magnetic navigation in patients with residual CTEPH after PEA.
METHODS


Fifty patients with residual CTEPH despite medical therapy at least 6 months after PEA, who had mean pulmonary artery pressure ≥25 mm Hg or pulmonary vascular resistance (PVR) > 400 dyn‧s‧cm -5  based on right heart catheterization were randomized to treatment with PADN (PADN group; n = 25) using remote magnetic navigation for ablation or medical therapy with riociguat (MED group; n = 25). In the MED group, a sham procedure with mapping but no ablation was performed. The primary endpoint was PVR at 12 months after randomization. Key secondary endpoint included 6-min walk test.
RESULTS


After PADN procedure, 2 patients (1 in each group) developed groin hematoma that resolved without any consequences. At 12 months, mean PVR reduction was 258 ± 135 dyn‧s‧cm -5  in the PADN group versus 149 ± 73 dyn‧s‧cm -5  in the MED group, mean between-group difference was 109 dyn‧s‧cm -5  (95% confidence interval: 45 to 171; p = 0.001). The 6-min walk test distance was significantly increased in the PADN group as compared to distance in the MED group (470 ± 84 m vs. 399 ± 116 m, respectively; p = 0.03).
CONCLUSIONS


PADN in patients with residual CTEPH resulted in substantial reduction of PVR at 12 months of follow-up, accompanied by improved 6-min walk test.",2020,"The 6-min walk test distance was significantly increased in the PADN group as compared to distance in the MED group (470 ± 84 m vs. 399 ± 116 m, respectively; p = 0.03).
","['Fifty patients with residual CTEPH despite medical therapy at least 6\xa0months after PEA, who had mean pulmonary artery pressure\xa0≥25', 'patients with residual chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary endarterectomy (PEA', 'patients with residual CTEPH after PEA', ' 400 dyn‧s‧cm -5  based on right heart catheterization', 'Patients With Residual Pulmonary Hypertension']","['PADN (PADN group; n\xa0=\xa025) using remote magnetic navigation for ablation or medical therapy with riociguat (MED group; n\xa0=\xa025', 'PADN', 'Pulmonary artery denervation (PADN) procedure']","['6-min walk test', '6-min walk test distance', 'substantial reduction of PVR', 'groin hematoma', 'safety and efficacy', 'Hg or pulmonary vascular resistance', 'mean PVR reduction', 'PVR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C2363973', 'cui_str': 'Chronic thromboembolic pulmonary hypertension'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2066034', 'cui_str': 'Pulmonary endarterectomy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0189896', 'cui_str': 'Catheterization of right heart'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}]","[{'cui': 'C0034052', 'cui_str': 'Pulmonary artery structure'}, {'cui': 'C0011307', 'cui_str': 'Denervation - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}, {'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary vascular resistance'}, {'cui': 'C0585249', 'cui_str': 'Hematoma of groin'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",50.0,0.0567703,"The 6-min walk test distance was significantly increased in the PADN group as compared to distance in the MED group (470 ± 84 m vs. 399 ± 116 m, respectively; p = 0.03).
","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Romanov', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation. Electronic address: abromanov@mail.ru.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Cherniavskiy', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Nataliya', 'Initials': 'N', 'LastName': 'Novikova', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Edemskiy', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Ponomarev', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Vitaliy', 'Initials': 'V', 'LastName': 'Shabanov', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Losik', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Dmitry', 'Initials': 'D', 'LastName': 'Elesin', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Ilya', 'Initials': 'I', 'LastName': 'Stenin', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Mikheenko', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Zhizhov', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Kretov', 'Affiliation': 'Center of Invasive Electrophysiology, E. Meshalkin National Medical Research Center Ministry of Health of the Russian Federation, Novosibirsk, Russian Federation.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Pokushalov', 'Affiliation': 'Russian Scientific Society of Clinical Electrophysiology, Arrhythmology, and Cardiac Pacing, Moscow, Russian Federation.'}, {'ForeName': 'Sunny S', 'Initials': 'SS', 'LastName': 'Po', 'Affiliation': 'Heart Rhythm Institute, University of Oklahoma Health Science Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Tamila V', 'Initials': 'TV', 'LastName': 'Martynyuk', 'Affiliation': 'A.L. Myasnikov Institute of Clinical Cardiology, Russian Cardiology Research and Production Complex, Ministry of Health of the Russian Federation, Moscow, Russian Federation.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Steinberg', 'Affiliation': 'Clinical Cardiovascular Research Center, University of Rochester School of Medicine and Dentistry, Rochester, New York.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.06.064']
2758,32819528,Quality of Life and Health Care Utilization in the CIRCA-DOSE Study.,"OBJECTIVES


This study evaluated the impact of contact force-guided radiofrequency ablation versus cryoballoon ablation on quality of life and health care utilization.
BACKGROUND


Traditional outcome parameters, such as arrhythmia-free survival, are insufficient to evaluate the clinical impact of atrial fibrillation (AF), as it fails to the capture patient- and health system-level differences in treatment approaches.
METHODS


The CIRCA-DOSE (Cryoballoon Vs. Contact-Force Atrial Fibrillation Ablation) study randomly assigned 346 patients with drug-refractory paroxysmal AF to contact force-guided radiofrequency or cryoballoon ablation. Health-related quality-of-life (HRQOL) was assessed at baseline, and at 6 and 12 months post-ablation using a disease-specific and generic HRQOL instruments. Health care utilization (hospitalization, emergency department visits, and cardioversion) and antiarrhythmic drug use for the 12 months preceding ablation was compared with the 12 months following ablation.
RESULTS


Disease-specific and generic HRQOL was moderately to severely impaired at baseline and improved significantly at 6 and 12 months of follow-up (median improvement in AFEQT [Atrial Fibrillation Effect on QualiTy of Life] score 32.4 [interquartile range: 17.7 to 48.9]). When compared with the 12 months pre-ablation, the proportion and absolute number of cardioversions decreased significantly (41.1% vs. 10.1% of patients, 137 vs. 35 events; p < 0.0001). Similar significant reductions in emergency department visits (66.7% vs. 25.1% of patients, 224 vs. 87 events; p < 0.0001), and hospitalizations (25.5% vs. 14.5% of patients, 86 vs. 50 events; p < 0.001) were observed. There were no significant differences between randomized groups.
CONCLUSIONS


In this multicenter randomized trial, catheter ablation with advanced-generation technologies resulted in a significant improvement in HRQOL and a significant reduction in health care utilization in the year following AF ablation. (Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation [CIRCA-DOSE]; NCT01913522).",2020,"Similar significant reductions in emergency department visits (66.7% vs. 25.1% of patients, 224 vs. 87 events; p < 0.0001), and hospitalizations (25.5% vs. 14.5% of patients, 86 vs. 50 events; p < 0.001) were observed.",['346 patients with drug-refractory paroxysmal AF to'],"['Cryoballoon vs. Irrigated Radiofrequency Catheter Ablation [CIRCA-DOSE', 'contact force-guided radiofrequency or cryoballoon ablation', 'catheter ablation with advanced-generation technologies', 'contact force-guided radiofrequency ablation versus cryoballoon ablation', 'AFEQT']","['Health care utilization (hospitalization, emergency department visits, and cardioversion) and antiarrhythmic drug use', 'Quality of Life and Health Care Utilization', 'emergency department visits', 'quality of life and health care utilization', 'HRQOL', 'proportion and absolute number of cardioversions', 'health care utilization', 'hospitalizations', 'Health-related quality-of-life (HRQOL', 'Disease-specific and generic HRQOL', 'QualiTy of Life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}]","[{'cui': 'C0162561', 'cui_str': 'Radiofrequency Catheter Ablation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]",346.0,0.0820205,"Similar significant reductions in emergency department visits (66.7% vs. 25.1% of patients, 224 vs. 87 events; p < 0.0001), and hospitalizations (25.5% vs. 14.5% of patients, 86 vs. 50 events; p < 0.001) were observed.","[{'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada; Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: jason.andrade@vch.ca.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Department of Medicine, Southlake Regional Health Center, Newmarket, Ontario, Canada.'}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': 'Heart Rhythm Services, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Champagne', 'Affiliation': 'Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Dubuc', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Leong-Sit', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': 'Department of Medicine, Royal Jubilee Hospital, Victoria, British Columbia, Canada.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Roux', 'Affiliation': 'Department of Medicine, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sapp', 'Affiliation': 'Department of Medicine, Queen Elizabeth II Health Sciences Centre and Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Clarence', 'Initials': 'C', 'LastName': 'Khoo', 'Affiliation': 'Department of Medicine, St. Boniface Hospital, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Rizkallah', 'Affiliation': 'Department of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Levesque', 'Affiliation': 'Montreal Health Innovations Coordinating Centre, Montreal, Québec, Canada.'}, {'ForeName': 'Anthony S L', 'Initials': 'ASL', 'LastName': 'Tang', 'Affiliation': 'Department of Medicine, University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada; Montreal Health Innovations Coordinating Centre, Montreal, Québec, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Clinical electrophysiology,['10.1016/j.jacep.2020.04.017']
2759,32819842,Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa.,"RESEARCH QUESTION


The objective of this investigation was to determine the daily follitropin delta dose (µg) providing a similar ovarian response to 150 IU/day follitropin alfa.
DESIGN


The study was a post-hoc analysis of ovarian response in 1591 IVF/intracytoplasmic sperm injection (ICSI) patients undergoing ovarian stimulation in a gonadotrophin-releasing hormone antagonist protocol in two recent randomized, assessor-blind, controlled trials in the development programme for follitropin delta: a phase II dose-response trial with a reference arm of a fixed daily dose of 150 IU follitropin alfa throughout stimulation, and a phase III efficacy trial with a comparator arm of 150 IU/day follitropin alfa as a starting dose.
RESULTS


Daily follitropin delta doses of 10.0 µg (95% confidence interval [CI] 7.9-12.8) and 10.3 µg (95% CI 9.7-10.8) yielded the same number of oocytes as 150 IU/day follitropin alfa for all patients participating in the phase II and III trials, respectively. When analysing patients with either normal or high ovarian reserve (based on serum anti-Mullerian hormone ≥15 pmol/l) and no dose changes, the same number of oocytes was obtained with 150 IU/day follitropin alfa and daily doses of follitropin delta of 9.7 µg (95% CI 7.5-12.4) and 9.3 µg (95% CI 8.6-10.1) in the two trials. Daily follitropin delta doses in the range 9.5-10.4 µg were consistently estimated to correspond to 150 IU/day follitropin alfa for serum oestradiol concentration and number of follicles ≥12 mm at the end of stimulation across analysis populations in the phase III trial.
CONCLUSIONS


A daily follitropin delta dose of 10 µg provides a similar ovarian response to 150 IU/day follitropin alfa in IVF/ICSI patients.",2020,A daily follitropin delta dose of 10 µg provides a similar ovarian response to 150 IU/day follitropin alfa in IVF/ICSI patients.,"['1591 IVF/intracytoplasmic sperm injection (ICSI) patients undergoing ovarian stimulation in a', 'IVF/ICSI patients']","['gonadotrophin-releasing hormone antagonist protocol', 'daily follitropin delta dose (µg) providing a similar ovarian response to 150\xa0IU/day follitropin alfa']",['ovarian response'],"[{'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4301617', 'cui_str': 'follitropin delta'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C1268876', 'cui_str': 'Follitropin Alfa'}]",[],,0.407696,A daily follitropin delta dose of 10 µg provides a similar ovarian response to 150 IU/day follitropin alfa in IVF/ICSI patients.,"[{'ForeName': 'Joan-Carles', 'Initials': 'JC', 'LastName': 'Arce', 'Affiliation': 'Ferring Pharmaceuticals, Reproductive Medicine & Maternal Health, Copenhagen, Denmark. Electronic address: jca@ferring.com.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Larsson', 'Affiliation': 'Ferring Pharmaceuticals, Global Biometrics, Copenhagen, Denmark.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'García-Velasco', 'Affiliation': 'IVI-RMA Madrid, Madrid, Spain.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.07.006']
2760,32819864,Pelvic Floor Biometric Changes Assessed by 4D Translabial Ultrassound in Women With Vulvodynia Submitted to Physical Therapy: A Pilot Study of a Randomized Controlled Trial.,"BACKGROUND


Vulvodynia is a disabling condition in which pelvic floor muscles' (PFM) hypertonicity plays an important role.
AIM


To evaluate biometric changes in PFM in women with vulvodynia undergoing kinesiotherapy treatment protocol (KTP).
METHODS


A single-blinded randomized controlled trial of 57 women with vulvodynia randomly assigned to either KTP + amitriptyline or amitriptyline alone (controls) for treatment. Four-dimensional translabial ultrasound assessed PFM regarding symphysis-levator distance at rest, anorectal angle at rest, excursion of the levator plate angle, and levator hiatal narrowing. Volunteers underwent a vaginal examination for a cotton swab test (CST), fulfillment of Friedrich criteria score and PFM power of contraction, and completed a diary of sexual pain and frequency of vaginal intercourse. Outcomes were assessed at baseline and after 8 weeks of treatment.
OUTCOMES


Primary outcomes were differences in biometric parameters assessed by four-dimensional translabial ultrasound after treatment, between groups. Secondary outcomes were changes in clinical variables (CST, Friedrich criteria, PFM power of contraction, frequency of intercourse, and intensity of sexual pain) between groups and correlation analysis between biometric parameters and clinical variables.
RESULTS


Only the KTP group had statistically significant changes in biometric parameters after treatment (symphysis-levator distance: 0.22 ± 0.2, 95% CI = 0.1-0.4, P = .008; levator hiatal narrowing: -0.33 ± 0.2, 95% CI = -1 to -0.2, P = .04). Comparisons between groups showed that symphysis-levator distance (0.3, 95% CI = 0.2-0.6, P = .005) and excursion of levator plate angle (4.9, 95% CI = -0.4 to 10.1, P = .02) improved significantly after KTP treatment. Clinical variables showed greater improvement in the group treated with KTP for CST (difference of -3.7, 95% CI = -7 to -0.4, P = .01), Friedrich criteria (difference of -1.9, 95% CI = -3.2 to -0.6, P = .003), PFM power of contraction (0.3, 95% CI = 0.1-0.6, P = .05) and intensity of sexual pain (reduction of 1.7, 95% CI = -3.1 to -0.2, P = .01). Some clinical and biometric variables correlated positively, for example, frequency of vaginal intercourse and anorectal angle (P = .04; r = 0.25), or inversely, for example, pain intensity at CST and anorectal angle (P = .004, r = -0.31).
CLINICAL IMPLICATIONS


This study provides evidence on efficiency of a physical therapy protocol for improvement of symptoms of vulvodynia and hypertonicity changes.
CONCLUSION


This pilot study suggests that KTP for women with vulvodynia promoted significant changes in PFM biometric measures, consistent with alterations in hypertonicity and clinical improvement. Bardin MG, Giraldo PC, Martinho N. Pelvic Floor Biometric Changes Assessed by 4D Translabial Ultrassound in Women With Vulvodynia Submitted to Physical Therapy: A Pilot Study of a Randomized Controlled Trial. J Sex Med 2020;XX:XXX-XXX.",2020,"RESULTS


Only the KTP group had statistically significant changes in biometric parameters after treatment (symphysis-levator distance: 0.22 ± 0.2, 95% CI = 0.1-0.4, P = .008; levator hiatal narrowing: -0.33 ± 0.2, 95% CI = -1 to -0.2, P = .04).","['women with vulvodynia undergoing kinesiotherapy treatment protocol (KTP', 'Women With Vulvodynia', '57 women with vulvodynia randomly assigned to either']","['KTP\xa0+\xa0amitriptyline or amitriptyline alone (controls', 'KTP', 'Physical Therapy']","['PFM power of contraction', 'intensity of sexual pain', 'symphysis-levator distance', 'PFM regarding symphysis-levator distance at rest, anorectal angle at rest, excursion of the levator plate angle, and levator hiatal narrowing', 'sexual pain and frequency of vaginal intercourse', 'excursion of levator plate angle', 'pain intensity at CST and anorectal angle', 'biometric parameters', 'PFM biometric measures', 'frequency of vaginal intercourse and anorectal angle', 'biometric parameters assessed by four-dimensional translabial ultrasound', 'changes in clinical variables (CST, Friedrich criteria, PFM power of contraction, frequency of intercourse, and intensity of sexual pain']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0406670', 'cui_str': 'Vulvodynia'}, {'cui': 'C1096702', 'cui_str': 'Kinesitherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C1096702', 'cui_str': 'Kinesitherapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0002600', 'cui_str': 'Amitriptyline'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0224520', 'cui_str': 'Symphysis structure'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0005971', 'cui_str': 'Bone plate'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0010196', 'cui_str': 'Gossypium'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442359', 'cui_str': 'Translabial approach'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",57.0,0.303753,"RESULTS


Only the KTP group had statistically significant changes in biometric parameters after treatment (symphysis-levator distance: 0.22 ± 0.2, 95% CI = 0.1-0.4, P = .008; levator hiatal narrowing: -0.33 ± 0.2, 95% CI = -1 to -0.2, P = .04).","[{'ForeName': 'Marcela Grigol', 'Initials': 'MG', 'LastName': 'Bardin', 'Affiliation': 'Faculty of Medical Sciences, University of Campinas - UNICAMP, Campinas, São Paulo, Brazil. Electronic address: bardinmarcela@gmail.com.'}, {'ForeName': 'Paulo César', 'Initials': 'PC', 'LastName': 'Giraldo', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Campinas - UNICAMP, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Martinho', 'Affiliation': 'Faculty of Medical Sciences, University of Campinas - UNICAMP, Campinas, São Paulo, Brazil.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2020.07.020']
2761,32819881,"Phase 1 Trial Evaluating Vorinostat Plus Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma.","INTRODUCTION


Bortezomib plus lenalidomide and dexamethasone (VRD) is a standard induction therapy for newly diagnosed multiple myeloma (NDMM) patients. Given preclinical and clinical data suggesting the synergistic activity of the histone deacetylase inhibitor vorinostat with both bortezomib and lenalidomide for the treatment of multiple myeloma, we hypothesized that adding vorinostat to VRD (R2V2) would increase the rate and the quality of responses to induction treatment. Here we report the results of a phase 1 trial (NCT01038388) evaluating R2V2 as up-front treatment for NDMM patients.
PATIENTS AND METHODS


R2V2 was tested as induction therapy in a dose-escalation phase 1 study in 30 NDMM patients deemed eligible for autologous stem-cell transplantation. Treatment consisted of 4 induction cycles with R2V2, followed by either autologous stem-cell transplantation or 4 additional R2V2 cycles and lenalidomide maintenance therapy.
RESULTS


The maximum tolerated dose of vorinostat was 200 mg daily. The most common adverse events were gastrointestinal (87%), fatigue and peripheral neuropathy (60%), and thrombocytopenia (33%). R2V2 induced an objective response in 96% of patients, with 48% obtaining at least a complete remission. Median progression-free survival was 52 months, with 77% of patients alive at 5 years.
CONCLUSION


R2V2 as induction treatment for NDMM patients resulted in remarkable response rates at the cost of increased toxicity.",2020,"R2V2 induced an objective response in 96% of patients, with 48% obtaining at least a complete remission.","['NDMM patients', '30 NDMM patients deemed eligible for autologous stem-cell transplantation', 'newly diagnosed multiple myeloma (NDMM) patients', 'Patients With Newly Diagnosed Multiple Myeloma']","['Vorinostat Plus Bortezomib, Lenalidomide, and Dexamethasone', 'Bortezomib plus lenalidomide and dexamethasone (VRD', '4 induction cycles with R2V2, followed by either autologous stem-cell transplantation or 4 additional R2V2 cycles and lenalidomide maintenance therapy']","['Median progression-free survival', 'fatigue and peripheral neuropathy', 'toxicity', 'thrombocytopenia', 'objective response']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}]","[{'cui': 'C0672708', 'cui_str': 'Vorinostat'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",30.0,0.0821328,"R2V2 induced an objective response in 96% of patients, with 48% obtaining at least a complete remission.","[{'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Mina', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA. Electronic address: roberto.mina.rm@gmail.com.'}, {'ForeName': 'Jatin J', 'Initials': 'JJ', 'LastName': 'Shah', 'Affiliation': 'Karyopharm Therapeutics, Newton, MA.'}, {'ForeName': 'Jacob P', 'Initials': 'JP', 'LastName': 'Laubach', 'Affiliation': 'LeBow Institute for Myeloma Therapeutics and Jerome Lipper Center for Multiple Myeloma Research, Harvard Medical School, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Ajay K', 'Initials': 'AK', 'LastName': 'Nooka', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Lewis', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Charise', 'Initials': 'C', 'LastName': 'Gleason', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Sharp', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'R Donald', 'Initials': 'RD', 'LastName': 'Harvey', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Leonard T', 'Initials': 'LT', 'LastName': 'Heffner', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'LeBow Institute for Myeloma Therapeutics and Jerome Lipper Center for Multiple Myeloma Research, Harvard Medical School, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'Sagar', 'Initials': 'S', 'LastName': 'Lonial', 'Affiliation': 'Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Robert Z', 'Initials': 'RZ', 'LastName': 'Orlowski', 'Affiliation': 'Department of Lymphoma/Myeloma, The University of Texas, MD Anderson Cancer Center, Houston, TX.'}]","Clinical lymphoma, myeloma & leukemia",['10.1016/j.clml.2020.07.013']
2762,32819923,Pretreatment with transcutaneous electrical acupoint stimulation to prevent postoperative ileus in patients undergoing laparoscopic colon surgery: study protocol for a randomised controlled trial.,"INTRODUCTION


Postoperative ileus (POI), a common complication after surgery, severely affects postoperative recovery. It is unclear whether pretreatment with transcutaneous electrical acupoint stimulation (TEAS) can improve recovery from POI. This trial will evaluate the effects of pretreatment with TEAS on POI.
METHODS AND ANALYSIS


This will be a prospective, randomised controlled trial. American Society of Anesthesiologists (ASA) physical status classification I-III level patients, aged 18-75 years and scheduled for laparoscopic colon surgery, will be included in the study. It is planned that 146 subjects will be randomised to the TEAS and sham TEAS (STEAS) groups. The groups will undergo two sessions of TEAS/STEAS daily for 3 days before surgery, with a final TEAS/STEAS treatment 30 min before anaesthesia. The primary endpoint of the study will be time to first defaecation. Secondary endpoints will include time to first flatus, time to tolerance of oral diet, GI-2 (composite outcome of time to first defaecation and time to tolerance of oral diet), time to independent walking, length of hospital stay, postoperative pain Visual Analogue Scale score on the first 3 days after surgery, analgesic requirements, complications and plasma concentrations of interferon-β (IFN-β), IFN-γ, interleukin-6 (IL-6) and IL-1β. Multiple linear regression will be used to identify independent predictors of outcome measures.
ETHICS AND DISSEMINATION


This study has been approved by the Chinese Registered Clinical Trial Ethics Review Committee (No. ChiECRCT-20170084). The results of the trial will be published in an international peer-reviewed journal.
TRIAL REGISTRATION NUMBER


This study has been registered with the Chinese Clinical Trial Registry (No. ChiCTR-INR-17013184).
TRIAL STATUS


The study was in the recruitment phase at the time of manuscript submission.",2020,It is unclear whether pretreatment with transcutaneous electrical acupoint stimulation (TEAS) can improve recovery from POI.,"['patients undergoing laparoscopic colon surgery', '146 subjects', 'American Society of Anesthesiologists (ASA) physical status classification I-III level patients, aged 18-75 years and scheduled for laparoscopic colon surgery']","['TEAS/STEAS', 'TEAS', 'transcutaneous electrical acupoint stimulation', 'transcutaneous electrical acupoint stimulation (TEAS', 'TEAS and sham TEAS (STEAS']","['time to first defaecation', 'postoperative ileus', 'time to first flatus, time to tolerance of oral diet, GI-2 (composite outcome of time to first defaecation and time to tolerance of oral diet), time to independent walking, length of hospital stay, postoperative pain Visual Analogue Scale score on the first 3\u2009days after surgery, analgesic requirements, complications and plasma concentrations of interferon-β (IFN-β), IFN-γ, interleukin-6 (IL-6) and IL-1β. Multiple linear regression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192817', 'cui_str': 'Operation on colon'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0039400', 'cui_str': 'Tea'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0429979', 'cui_str': 'Independent walking'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023733', 'cui_str': 'Linear Regression'}]",146.0,0.238662,It is unclear whether pretreatment with transcutaneous electrical acupoint stimulation (TEAS) can improve recovery from POI.,"[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Dongli', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Anesthesiology, Wenzhou Medical University, the sixth Affiliated Hospital, Lishui, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Yong', 'Affiliation': 'Research Institute of Acupuncture Anesthesia, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Guijie', 'Initials': 'G', 'LastName': 'Yu', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Feng', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Fu', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jiangang', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lihua', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': 'Anesthesiology, Wenzhou Medical University, the sixth Affiliated Hospital, Lishui, China fanlihua_ls@126.com.'}]",BMJ open,['10.1136/bmjopen-2019-030694']
2763,32819928,ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy): a randomised controlled trial of an innovative intervention for infants at risk of autism spectrum disorder.,"INTRODUCTION


Autism spectrum disorder (ASD) is a heterogeneous neurodevelopmental condition with impacts on behaviour, cognition, communication, social interaction and family mental health. This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD.
METHODS AND ANALYSIS


We aim to recruit 66 mothers of infants at risk of ASD (ie, infants with a sibling or parent diagnosed with ASD) to this RCT. Families will be randomly assigned to care-as-usual or ENACT. ENACT is a very early intervention, leveraging parent-child interactions to improve early social reciprocity, while supporting parental mental health and the parent-child relationship through Acceptance and Commitment Therapy. Intervention content is delivered online (approximately 8 hours) and supported by more than 7 consultations with a clinician. Parents will perform the social reciprocity intervention with their child (30 min per day). Assessments at four time points (baseline, 3 months, 6 months, and 12 months corrected age) will assess parent-infant interaction, parental mental health, infant development and early ASD markers. Analysis will be by intention to treat using general linear models for RCTs.
ETHICS AND DISSEMINATION


This protocol has been approved by the Children's Health Queensland Hospital and Health Service Human Research Ethics Committee (HREC/19/QCHQ/50131) and the University of Queensland Human Research Ethics Committee (2019000558). If efficacy is demonstrated, the intervention has the potential for wide and accessible dissemination.
TRIAL REGISTRATION NUMBER


Australian New Zealand Clinical Trials Registry (ACTRN12618002046280).",2020,"This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD.
","['infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD', 'infants at risk of autism spectrum disorder', 'Autism spectrum disorder (ASD', '66 mothers of infants at risk of ASD (ie, infants with a sibling or parent diagnosed with ASD) to this RCT']","['ENACT (ENvironmental enrichment', 'innovative intervention', 'ENACT', 'social reciprocity intervention']","['parent-infant interaction, parental mental health, infant development and early ASD markers']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205714', 'cui_str': 'Infant Development'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.264507,"This paper reports the protocol of a randomised controlled trial (RCT) of a very early intervention, ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy), for families of infants at risk of ASD.
","[{'ForeName': 'Koa', 'Initials': 'K', 'LastName': 'Whittingham', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia koawhittingham@uq.edu.au.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'McGlade', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Kavindri', 'Initials': 'K', 'LastName': 'Kulasinghe', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Mitchell', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Honey', 'Initials': 'H', 'LastName': 'Heussler', 'Affiliation': 'Mater Medical Research Institute, South Brisbane, Queensland, Australia.'}, {'ForeName': 'Roslyn N', 'Initials': 'RN', 'LastName': 'Boyd', 'Affiliation': 'Queensland Cerebral Palsy and Rehabilitation Research Centre, UQ Child Health Research Centre, Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.'}]",BMJ open,['10.1136/bmjopen-2019-034315']
2764,32819929,"Multiple-dose tranexamic acid for perioperative blood loss in total knee arthroplasty in patients with rheumatoid arthritis：a single-blinded, randomised, parallel-controlled study protocol in China.","INTRODUCTION


This clinical trial is designed to evaluate the effect of multiple-dose tranexamic acid (TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA).
METHODS AND ANALYSIS


A randomised, single-blinded, parallel-controlled study will be designed. Patients with RA (age 50-75 years) undergoing unilateral primary end-stage total knee arthroplasty will be randomly divided into group A or group B. Group A will be treated with one dose of TXA (1 g; intravenous injection 3 hours postsurgery) and group B with three doses (1 g; intravenous injection at 3, 6 and 12 hours postsurgery) after surgery. The primary outcomes will be evaluated with blood loss, maximum haemoglobin drop and transfusion rate. The secondary outcomes will be evaluated with knee function and complications.
ETHICS AND DISSEMINATION


The Shanghai Guanghua Hospital of Integrated Traditional Chinese Medicine and Western Medicine Ethics Committee approved in this study in July 2019. Informed consent will be obtained from all participants. Results of the trial will be published in the Dryad and repository in a peer-reviewed journal. Additionally, deidentified data collected and analysed for this study will be available for review from the corresponding author on reasonable request.
TRIAL REGISTRATION NUMBER


ChiCTR1900025013.",2020,"Patients with RA (age 50-75 years) undergoing unilateral primary end-stage total knee arthroplasty will be randomly divided into group A or group B. Group A will be treated with one dose of TXA (1 g; intravenous injection 3 hours postsurgery) and group B with three doses (1 g; intravenous injection at 3, 6 and 12 hours postsurgery) after surgery.","['patients with rheumatoid arthritis (RA', 'Patients with RA (age 50-75 years) undergoing unilateral primary end-stage total knee arthroplasty', 'total knee arthroplasty in patients with rheumatoid arthritis：a single-blinded']","['tranexamic acid (TXA', 'tranexamic acid', 'TXA']","['blood loss, maximum haemoglobin drop and transfusion rate', 'knee function and complications', 'perioperative blood loss']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}]","[{'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.222455,"Patients with RA (age 50-75 years) undergoing unilateral primary end-stage total knee arthroplasty will be randomly divided into group A or group B. Group A will be treated with one dose of TXA (1 g; intravenous injection 3 hours postsurgery) and group B with three doses (1 g; intravenous injection at 3, 6 and 12 hours postsurgery) after surgery.","[{'ForeName': 'Bing-Xin', 'Initials': 'BX', 'LastName': 'Kang', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Chen-Xin', 'Initials': 'CX', 'LastName': 'Gao', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhong', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Song-Tao', 'Initials': 'ST', 'LastName': 'Sun', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Ying-Hui', 'Initials': 'YH', 'LastName': 'Ma', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Wei-Tao', 'Initials': 'WT', 'LastName': 'Zhai', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}, {'ForeName': 'Lian-Bo', 'Initials': 'LB', 'LastName': 'Xiao', 'Affiliation': 'Orthopaedics, ShangHai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China 13701888178@163.com.'}]",BMJ open,['10.1136/bmjopen-2019-034431']
2765,32819927,"Oral versus intramuscular administration of vitamin B12 for vitamin B12 deficiency in primary care: a pragmatic, randomised, non-inferiority clinical trial (OB12).","OBJECTIVES


To compare the effectiveness of oral versus intramuscular (IM) vitamin B 12  (VB12) in patients aged ≥65 years with VB12 deficiency.
DESIGN


Pragmatic, randomised, non-inferiority, multicentre trial in 22 primary healthcare centres in Madrid (Spain).
PARTICIPANTS


283 patients ≥65 years with VB12 deficiency were randomly assigned to oral (n=140) or IM (n=143) treatment arm.
INTERVENTIONS


The IM arm received 1 mg VB12 on alternate days in weeks 1-2, 1 mg/week in weeks 3-8 and 1 mg/month in weeks 9-52. The oral arm received 1 mg/day in weeks 1-8 and 1 mg/week in weeks 9-52.
MAIN OUTCOMES


Serum VB12 concentration normalisation (≥211 pg/mL) at 8, 26 and 52 weeks. Non-inferiority would be declared if the difference between arms is 10% or less. Secondary outcomes included symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction.
RESULTS


The follow-up period (52 weeks) was completed by 229 patients (80.9%). At week 8, the percentage of patients in each arm who achieved normal B 12  levels was well above 90%; the differences in this percentage between the oral and IM arm were -0.7% (133 out of 135 vs 129 out of 130; 95% CI: -3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: -1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis. At week 52, the percentage of patients who achieved normal B 12  levels was 73.6% in the oral arm and 80.4% in the IM arm; these differences were -6.3% (103 out of 112 vs 115 out of 117; 95% CI: -11.9 to -0.1; p=0.025) and -6.8% (103 out of 140 vs 115 out of 143; 95% CI: -16.6 to 2.9; p=0.171), respectively. Factors affecting the success rate at week 52 were age, OR=0.95 (95% CI: 0.91 to 0.99) and having reached VB12 levels ≥281 pg/mL at week 8, OR=8.1 (95% CI: 2.4 to 27.3). Under a Bayesian framework, non-inferiority probabilities (Δ>-10%) at week 52 were 0.036 (PPT) and 0.060 (ITT). Quality of life and adverse effects were comparable across groups. 83.4% of patients preferred the oral route.
CONCLUSIONS


Oral administration was no less effective than IM administration at 8 weeks. Although differences were found between administration routes at week 52, the probability that the differences were below the non-inferiority threshold was very low.
TRIAL REGISTRATION NUMBERS


NCT01476007; EUDRACT (2010-024129-20).",2020,(133 out of 135 vs 129 out of 130; 95% CI: -3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: -1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis.,"['patients aged ≥65 years with VB12 deficiency', '22 primary healthcare centres in Madrid (Spain', '283 patients ≥65 years with VB12 deficiency']","['vitamin B12', 'oral versus intramuscular (IM) vitamin B 12  (VB12']","['normal B 12  levels', 'Quality of life and adverse effects', 'Serum VB12 concentration normalisation', 'symptoms, adverse events, adherence to treatment, quality of life, patient preferences and satisfaction', 'success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4708786', 'cui_str': '283'}]","[{'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0376409', 'cui_str': 'Patient Preference'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",22.0,0.335499,(133 out of 135 vs 129 out of 130; 95% CI: -3.2 to 1.8; p>0.999) by per-protocol (PPT) analysis and 4.8% (133 out of 140 vs 129 out of 143; 95% CI: -1.3 to 10.9; p=0.124) by intention-to-treat (ITT) analysis.,"[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Sanz-Cuesta', 'Affiliation': 'Research Unit. Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Esperanza', 'Initials': 'E', 'LastName': 'Escortell-Mayor', 'Affiliation': 'Research Unit. Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Cura-Gonzalez', 'Affiliation': 'Research Unit. Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain isabel.cura@salud.madrid.org.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Martin-Fernandez', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': 'Riesgo-Fuertes', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Garrido-Elustondo', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Jose Enrique', 'Initials': 'JE', 'LastName': 'Mariño-Suárez', 'Affiliation': 'Healthcare Centre El Greco, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Álvarez-Villalba', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Tomás', 'Initials': 'T', 'LastName': 'Gómez-Gascón', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'González-García', 'Affiliation': 'Healthcare Centre Barajas, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'González-Escobar', 'Affiliation': 'Healthcare Centre Buenos Aires, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Vargas-Machuca Cabañero', 'Affiliation': 'Healthcare Centre Guayaba, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Noguerol-Álvarez', 'Affiliation': 'Healthcare Centre Cuzco, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'García de Blas-González', 'Affiliation': 'Health Services Research on Chronic Patients Network (REDISSEC), Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Baños-Morras', 'Affiliation': 'Healthcare Centre Buenos Aires, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Díaz-Laso', 'Affiliation': 'Healthcare Centre Fuentelarreina, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Caballero-Ramírez', 'Affiliation': 'Healthcare Centre Juncal, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Herrero de-Dios', 'Affiliation': 'Healthcare Centre Miguel de Cervantes, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Fernández-García', 'Affiliation': 'Healthcare Centre Santa Isabel, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Herrero-Hernández', 'Affiliation': 'Healthcare Centre Lavapiés, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Pose-García', 'Affiliation': 'Healthcare Centre Mendiguchía Carriche, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'María Luisa', 'Initials': 'ML', 'LastName': 'Sevillano-Palmero', 'Affiliation': 'Pharmacy Department, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Mateo-Ruiz', 'Affiliation': 'Pharmacy Department, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Medina-Bustillo', 'Affiliation': 'Pharmacy Department, Gerencia Asistencial Atención Primaria, Servicio Madrileno de Salud, Madrid, Spain.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Aguilar-Jiménez', 'Affiliation': 'UICEC Hospital Ramón y Cajal. Plataforma SCReN, Hospital Ramón y Cajal; Instituto Ramón y Cajal de Investigación Sanitaria IRYCIS, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-033687']
2766,32819944,"Protocol of a multicenter, single-blind, randomised, parallel controlled feeding trial evaluating the effect of a Chinese Healthy Heart (CHH) diet in lowering blood pressure and other cardiovascular risk factors.","INTRODUCTION


Unhealthy diet has been identified as the number one attributor of total mortality in China, accounting for more than 20% of total deaths. Although the Dietary Approach to Stop Hypertension (DASH) and Mediterranean diets have been proven beneficial in managing cardiovascular risk factors in Western countries, whether healthy diets with similar cardiovascular benefits can be developed that are consistent with Chinese food culture remains unknown.
METHODS/DESIGN


The Diet, ExerCIse and CarDiovascular hEalth (DECIDE)-Diet trial is a multicentre, single-blind, randomised controlled feeding trial to evaluate the effect of the Chinese Healthy Heart (CHH) diet, in comparison with the Chinese usual diet, in lowering cardiovascular risk factors among community residents with the increased cardiovascular risk. A total of 360 adults aged between 25 and 75 years old and with systolic blood pressure between 130 and 159 mm Hg will be recruited from four centres located in four areas representing four major Chinese cuisines: Beijing, Shanghai, Guangzhou and Chengdu. After 1 week of run-in period with local usual diet, the compliant participants will be randomised to the intervention group with the CHH diet or the control group with the usual local diet, on a 1:1 ratio, for 4 weeks. Body weight of study participants will be maintained during the entire study period. The primary outcome is the change in SBP from the baseline to the end of the study. DECIDE-Diet trial will be the first randomised controlled feeding trial to evaluate the effect of a CHH diet in lowering cardiovascular risk factors. This trial will provide compelling evidence on the CHH diet in effect of improving cardiovascular health among Chinese food consumers all around the world.
ETHICS AND DISSEMINATION


This trial adheres to the Declaration of Helsinki and guidelines of Good Clinical Practice. Signed informed consent will be obtained from all participants. The trial has been approved by the Peking University Institutional Review Board (approval number: IRB00001052-18094). The results will be disseminated through academic conferences and publications in international peer-reviewed journals.
TRAIL REGISTRATION NUMBER


ClinicalTrials.gov Registry (NCT03882645); Pre-results.",2020,"A total of 360 adults aged between 25 and 75 years old and with systolic blood pressure between 130 and 159 mm Hg will be recruited from four centres located in four areas representing four major Chinese cuisines: Beijing, Shanghai, Guangzhou and Chengdu.","['community residents with the increased cardiovascular risk', '360 adults aged between 25 and 75 years old and with systolic blood pressure between 130 and 159\u2009mm Hg will be recruited from four centres located in four areas representing four major Chinese cuisines: Beijing, Shanghai, Guangzhou and Chengdu']","['Chinese Healthy Heart (CHH) diet', 'CHH diet or the control group with the usual local diet', 'CHH diet']","['blood pressure and other cardiovascular risk factors', 'change in SBP', 'Diet, ExerCIse and CarDiovascular hEalth']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C4042832', 'cui_str': 'Peking'}]","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205276', 'cui_str': 'Local'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",360.0,0.111837,"A total of 360 adults aged between 25 and 75 years old and with systolic blood pressure between 130 and 159 mm Hg will be recruited from four centres located in four areas representing four major Chinese cuisines: Beijing, Shanghai, Guangzhou and Chengdu.","[{'ForeName': 'Wuxiang', 'Initials': 'W', 'LastName': 'Xie', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yanfang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Peking University Clinical Research Institute, Peking University Health Science Center, Beijing, China pucri_wangyf1225@bjmu.edu.cn.'}, {'ForeName': 'Jianqin', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Clinical Nutrition Center, Huadong Hospital affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Zeng', 'Affiliation': 'Department of Nutrition, Food Safety and Toxicology, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Huilian', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhenquan', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'College of Tourism and Culinary Science, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, China CDC, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Pao-Hwa', 'Initials': 'PH', 'LastName': 'Lin', 'Affiliation': 'Department of Medicine, Nephrology Division, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Society of Health Risk Assessment & Control, Chinese Preventive Medicine Association, Beijing, China.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Infectious Disease Prevention and Control, National Institute for Communicable Disease Control and Prevention, China CDC, Beijing, China.'}, {'ForeName': 'Junshi', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Key Laboratory of Food Safety Risk Assessment of Ministry of Health, National Center for Food Safety Risk Assessment, Beijing, China.'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}]",BMJ open,['10.1136/bmjopen-2019-036394']
2767,32816830,"Does Fibre-fix provided to people with irritable bowel syndrome who are consuming a low FODMAP diet improve their gut health, gut microbiome, sleep and mental health? A double-blinded, randomised controlled trial.","INTRODUCTION


A diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) is an effective way to reduce gut symptoms in people with irritable bowel syndrome (IBS). This diet reduces the intake of fermentable fibres, leading to changes of the gut microbiota and insufficient fermentation in the large bowel, resulting in reduced production of short-chain fatty acids (SCFAs), such as butyrate, which has unfavourable implications for gut health, sleep and mental health. This study will examine the effect of Fibre-fix, a supplement containing a mix of dietary fibres, on the human gut microbiome composition, fermentative capacity, sleep, quality of life (QOL) and mental health of people with IBS who consume a low FODMAP diet (LFD).
METHODS AND ANALYSIS


A randomised, double-blind, placebo-controlled, study design is proposed to examine whether Fibre-fix added to an existing LFD may help modulate gastrointestinal function, improve markers of sleep, mental health and promote QOL in patients with IBS. Participants will provide stool and blood samples, daily bowel symptoms diaries and 3-day diet records. Additionally, they will complete validated questionnaires relating to FODMAP intake, sleep, mental health and QOL before and after a 3-week intervention. Gut health will be assessed via faecal microbiome composition, faecal pH and SCFA levels. Alteration of sleep will be recorded using an actigraphy device worn by all participants over the whole study. Multivariate analysis will be used to examine the gut microbiome and repeated measures Analysis of variance (ANOVA) will be used for dependent variables from questionnaires related to bowel symptoms, stool type, sleep, mental health and QOL to assess the differences between intervention and control groups after adjustment for confounding variables.
ETHICS AND DISSEMINATION


Ethics approval was obtained from the Human Research Ethics Committee of Edith Cowan University (2019-00619-YAN). Results will be disseminated in peer-review journal publications, and conference presentations. Participants will be provided with a summary of findings once the study is completed. If Fibre-fix is shown to result in favourable changes in gut microbial composition, SCFA production, sleep and mental well-being without exacerbating symptoms, this will provide additional dietary management options for those with IBS following an LFD.
TRIAL REGISTRATION NUMBER


ACTRN12620000032954.",2020,"If Fibre-fix is shown to result in favourable changes in gut microbial composition, SCFA production, sleep and mental well-being without exacerbating symptoms, this will provide additional dietary management options for those with IBS following an LFD.
","['people with irritable bowel syndrome', 'people with irritable bowel syndrome (IBS', 'people with IBS who consume a low FODMAP diet (LFD', 'patients with IBS']",['placebo'],"['FODMAP intake, sleep, mental health and QOL', 'bowel symptoms, stool type, sleep, mental health and QOL', 'faecal microbiome composition, faecal pH and SCFA levels', 'human gut microbiome composition, fermentative capacity, sleep, quality of life (QOL) and mental health']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0012611', 'cui_str': 'Disaccharide'}, {'cui': 'C0026492', 'cui_str': 'Monosaccharide'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4728066', 'cui_str': 'Low FODMAP diet'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C0012611', 'cui_str': 'Disaccharide'}, {'cui': 'C0026492', 'cui_str': 'Monosaccharide'}, {'cui': 'C0071629', 'cui_str': 'polyol'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C2711455', 'cui_str': 'Fecal pH'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",,0.320202,"If Fibre-fix is shown to result in favourable changes in gut microbial composition, SCFA production, sleep and mental well-being without exacerbating symptoms, this will provide additional dietary management options for those with IBS following an LFD.
","[{'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Yan', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia r.yan@ecu.edu.au.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Murphy', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Genoni', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Evania', 'Initials': 'E', 'LastName': 'Marlow', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Dunican', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'School of Science, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Andrew', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Devine', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}, {'ForeName': 'Claus T', 'Initials': 'CT', 'LastName': 'Christophersen', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.'}]",BMJ open gastroenterology,['10.1136/bmjgast-2020-000448']
2768,32816839,Effectiveness of patient education in acute stroke: a comparison between a customised computer system and a pictorial information booklet.,"BACKGROUND


Patients who develop acute stroke are at high risk for deterioration in the first 48-72 hours after admission. An effective educational intervention is needed.
OBJECTIVE


This study aimed to examine the applicability of the customised interactive computer education system (CICS) in patients who had a stroke in the early acute phase in order to determine the efficacy of the education system in (1) information satisfaction and (2) physiological related management compliance.
METHODS


The prospective non-blinded randomised controlled study was conducted in an acute stroke unit of a local hospital in Hong Kong from March to August 2019. Chinese participants were selected if they were at least 18 years of age, experienced a minor stroke within 3 days. The exclusion criteria were communication problem and comorbidity with another acute disease. On the first day of admission, participants were allocated to the CICS and booklet groups, with each group comprising 50 participants. On the third day, the primary outcome, Modified Information Satisfaction Questionnaire for Acute Stroke (MISQ-S), was assessed.
RESULTS


There was a significant difference in 'the need to improve information measures' of the MISQ-S (p=0.04) between the CICS and booklet groups. The management compliance of these two groups did not have difference, but the CICS group had better clinical outcome, though not significant (p=0.387).
CONCLUSION


Patient education was needed and feasible in the early acute phase, and the CICS was more efficacious than the booklet. The positive results provided insights into and give a direction to the use of information technology in patient education.",2020,There was a significant difference in 'the need to improve information measures' of the MISQ-S (p=0.04) between the CICS and booklet groups.,"['acute stroke', 'Patients who develop acute stroke', 'Chinese participants were selected if they were at least 18 years of age, experienced a minor stroke within 3 days', 'acute stroke unit of a local hospital in Hong Kong from March to August 2019', 'patients who had a stroke in the early acute phase']","['customised interactive computer education system (CICS', 'patient education', 'customised computer system and a pictorial information booklet']",['Modified Information Satisfaction Questionnaire for Acute Stroke (MISQ-S'],"[{'cui': 'C0751956', 'cui_str': 'Acute stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439557', 'cui_str': 'Acute phase'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0009612', 'cui_str': 'Computer Systems'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}]",50.0,0.0888328,There was a significant difference in 'the need to improve information measures' of the MISQ-S (p=0.04) between the CICS and booklet groups.,"[{'ForeName': 'Yin Man', 'Initials': 'YM', 'LastName': 'Chu', 'Affiliation': 'Department of Medicine, Tseung Kwan O Hospital, Tseung Kwan O, Hong Kong cymz02@ha.org.hk.'}, {'ForeName': 'Kup Sze', 'Initials': 'KS', 'LastName': 'Choi', 'Affiliation': 'School of Nursing, Hong Kong Polytechnic University, Kowloon, Hong Kong.'}]",BMJ health & care informatics,['10.1136/bmjhci-2020-100144']
2769,32816842,Long term survival and local control outcomes from single dose targeted intraoperative radiotherapy during lumpectomy (TARGIT-IORT) for early breast cancer: TARGIT-A randomised clinical trial.,"OBJECTIVE


To determine whether risk adapted intraoperative radiotherapy, delivered as a single dose during lumpectomy, can effectively replace postoperative whole breast external beam radiotherapy for early breast cancer.
DESIGN


Prospective, open label, randomised controlled clinical trial.
SETTING


32 centres in 10 countries in the United Kingdom, Europe, Australia, the United States, and Canada.
PARTICIPANTS


2298 women aged 45 years and older with invasive ductal carcinoma up to 3.5 cm in size, cN0-N1, eligible for breast conservation and randomised before lumpectomy (1:1 ratio, blocks stratified by centre) to either risk adapted targeted intraoperative radiotherapy (TARGIT-IORT) or external beam radiotherapy (EBRT).
INTERVENTIONS


Random allocation was to the EBRT arm, which consisted of a standard daily fractionated course (three to six weeks) of whole breast radiotherapy, or the TARGIT-IORT arm. TARGIT-IORT was given immediately after lumpectomy under the same anaesthetic and was the only radiotherapy for most patients (around 80%). TARGIT-IORT was supplemented by EBRT when postoperative histopathology found unsuspected higher risk factors (around 20% of patients).
MAIN OUTCOME MEASURES


Non-inferiority with a margin of 2.5% for the absolute difference between the five year local recurrence rates of the two arms, and long term survival outcomes.
RESULTS


Between 24 March 2000 and 25 June 2012, 1140 patients were randomised to TARGIT-IORT and 1158 to EBRT. TARGIT-IORT was non-inferior to EBRT: the local recurrence risk at five year complete follow-up was 2.11% for TARGIT-IORT compared with 0.95% for EBRT (difference 1.16%, 90% confidence interval 0.32 to 1.99). In the first five years, 13 additional local recurrences were reported (24/1140  v  11/1158) but 14 fewer deaths (42/1140  v  56/1158) for TARGIT-IORT compared with EBRT. With long term follow-up (median 8.6 years, maximum 18.90 years, interquartile range 7.0-10.6) no statistically significant difference was found for local recurrence-free survival (hazard ratio 1.13, 95% confidence interval 0.91 to 1.41, P=0.28), mastectomy-free survival (0.96, 0.78 to 1.19, P=0.74), distant disease-free survival (0.88, 0.69 to 1.12, P=0.30), overall survival (0.82, 0.63 to 1.05, P=0.13), and breast cancer mortality (1.12, 0.78 to 1.60, P=0.54). Mortality from other causes was significantly lower (0.59, 0.40 to 0.86, P=0.005).
CONCLUSION


For patients with early breast cancer who met our trial selection criteria, risk adapted immediate single dose TARGIT-IORT during lumpectomy was an effective alternative to EBRT, with comparable long term efficacy for cancer control and lower non-breast cancer mortality. TARGIT-IORT should be discussed with eligible patients when breast conserving surgery is planned.
TRIAL REGISTRATION


ISRCTN34086741, NCT00983684.",2020,TARGIT-IORT was non-inferior to EBRT:,"['Between 24 March 2000 and 25 June 2012, 1140 patients', 'patients with early breast cancer who met our trial selection criteria', 'early breast cancer', '2298 women aged 45 years and older with invasive ductal carcinoma up to 3.5 cm in size, cN0-N1, eligible for breast conservation and randomised before lumpectomy (1:1 ratio, blocks stratified by centre) to either', '32 centres in 10 countries in the United Kingdom, Europe, Australia, the United States, and Canada']","['whole breast radiotherapy, or the TARGIT-IORT arm', 'risk adapted targeted intraoperative radiotherapy (TARGIT-IORT) or external beam radiotherapy (EBRT', 'EBRT', 'intraoperative radiotherapy during lumpectomy (TARGIT-IORT']","['mastectomy-free survival', 'local recurrence-free survival', 'breast cancer mortality', 'five year local recurrence rates', 'overall survival', 'local recurrence risk', 'distant disease-free survival', 'Mortality', 'deaths', 'local recurrences']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C4517539', 'cui_str': '1140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1134719', 'cui_str': 'Infiltrating ductular carcinoma'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0851238', 'cui_str': 'Lumpectomy of breast'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}, {'cui': 'C0851238', 'cui_str': 'Lumpectomy of breast'}]","[{'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",2298.0,0.234084,TARGIT-IORT was non-inferior to EBRT:,"[{'ForeName': 'Jayant S', 'Initials': 'JS', 'LastName': 'Vaidya', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK jayantvaidya@gmail.com.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bulsara', 'Affiliation': 'Department of Biostatistics, University of Notre Dame, Fremantle, WA, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baum', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Wenz', 'Affiliation': 'Department of Radiation Oncology, University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Samuele', 'Initials': 'S', 'LastName': 'Massarut', 'Affiliation': 'Department of Surgery, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.'}, {'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'Pigorsch', 'Affiliation': 'Department of Gynaecology and Obstetrics, Red Cross Hospital, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Alvarado', 'Affiliation': 'Department of Surgery, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Douek', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Christobel', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': 'School of Surgery, University of Western Australia, Crawley, WA, Australia.'}, {'ForeName': 'Henrik L', 'Initials': 'HL', 'LastName': 'Flyger', 'Affiliation': 'Department of Breast Surgery, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Eiermann', 'Affiliation': 'Department of Gynaecology and Obstetrics, Red Cross Hospital, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brew-Graves', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK.'}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Potyka', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Roberts', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, 43-45 Foley Street, London W1W 7JN, UK.'}, {'ForeName': 'Marcelle', 'Initials': 'M', 'LastName': 'Bernstein', 'Affiliation': 'London, UK.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Department of Surgery, Ninewells Hospital, Dundee, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Sperk', 'Affiliation': 'Department of Radiation Oncology, University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Laws', 'Affiliation': 'Department of Surgery, Royal Hampshire County Hospital, Winchester, UK.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sütterlin', 'Affiliation': 'Department of Gynaecology and Obstetrics, University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Corica', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Steinar', 'Initials': 'S', 'LastName': 'Lundgren', 'Affiliation': ""Department of Oncology, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Holmes', 'Affiliation': 'University of Southern California, John Wayne Cancer Institute & Helen Rey Breast Cancer Foundation, Los Angeles, CA, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Vinante', 'Affiliation': 'Department of Radiation Oncology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bozza', 'Affiliation': 'Instituto Oncologico Veneto, Padoa, Italy.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Pazos', 'Affiliation': 'Department of Radiation Oncology, University Hospital, The Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Le Blanc-Onfroy', 'Affiliation': 'Radiotherapy-Oncology, Western Cancer Institute, Nantes, France.'}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Gruber', 'Affiliation': 'Breast Centre Seefeld, Zurich, Switzerland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Polkowski', 'Affiliation': 'Department of Surgical Oncology, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Konstantin J', 'Initials': 'KJ', 'LastName': 'Dedes', 'Affiliation': 'Breast Centre, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Niewald', 'Affiliation': 'Saarland University Medical Center, Homberg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Blohmer', 'Affiliation': 'Sankt Gertrauden Hospital, Charité, Medical University of Berlin, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McCready', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hoefer', 'Affiliation': 'Sentara Surgery Specialists, Hampton, VA, USA.'}, {'ForeName': 'Pond', 'Initials': 'P', 'LastName': 'Kelemen', 'Affiliation': 'Ashikari Breast Center, New York Medical College, New York, NY, USA.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Petralia', 'Affiliation': 'Department of Surgery, University College London Hospitals, London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Falzon', 'Affiliation': 'Department of Pathology, University College London Hospitals, London, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Joseph', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Tobias', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.m2836']
2770,32816872,Exercise training improves adipose tissue metabolism and vasculature regardless of baseline glucose tolerance and sex.,"INTRODUCTION


We investigated the effects of a supervised progressive sprint interval training (SIT) and moderate-intensity continuous training (MICT) on adipocyte morphology and adipose tissue metabolism and function; we also tested whether the responses were similar regardless of baseline glucose tolerance and sex.
RESEARCH DESIGN AND METHODS


26 insulin-resistant (IR) and 28 healthy participants were randomized into 2-week-long SIT (4-6×30 s at maximum effort) and MICT (40-60 min at 60% of maximal aerobic capacity (VO 2peak )). Insulin-stimulated glucose uptake and fasting-free fatty acid uptake in visceral adipose tissue (VAT), abdominal and femoral subcutaneous adipose tissues (SATs) were quantified with positron emission tomography. Abdominal SAT biopsies were collected to determine adipocyte morphology, gene expression markers of lipolysis, glucose and lipid metabolism and inflammation.
RESULTS


Training increased glucose uptake in VAT (p<0.001) and femoral SAT (p<0.001) and decreased fatty acid uptake in VAT (p=0.01) irrespective of baseline glucose tolerance and sex. In IR participants, training increased adipose tissue vasculature and decreased CD36 and ANGPTL4 gene expression in abdominal SAT. SIT was superior in increasing VO 2peak  and VAT glucose uptake in the IR group, whereas MICT reduced VAT fatty acid uptake more than SIT.
CONCLUSIONS


Short-term training improves adipose tissue metabolism both in healthy and IR participants independently of the sex. Adipose tissue angiogenesis and gene expression was only significantly affected in IR participants.",2020,"RESULTS


Training increased glucose uptake in VAT (p<0.001) and femoral SAT (p<0.001) and decreased fatty acid uptake in VAT (p=0.01) irrespective of baseline glucose tolerance and sex.",['26 insulin-resistant (IR) and 28 healthy participants'],"['MICT', 'supervised progressive sprint interval training (SIT) and moderate-intensity continuous training (MICT', 'Exercise training', 'Short-term training']","['adipose tissue metabolism and vasculature regardless of baseline glucose tolerance and sex', 'adipocyte morphology and adipose tissue metabolism and function', 'adipose tissue metabolism', 'glucose uptake in VAT (p<0.001) and femoral SAT (p<0.001) and decreased fatty acid uptake', 'Adipose tissue angiogenesis and gene expression', 'Insulin-stimulated glucose uptake and fasting-free fatty acid uptake in visceral adipose tissue (VAT), abdominal and femoral subcutaneous adipose tissues (SATs', 'VO 2peak  and VAT glucose uptake', 'adipocyte morphology, gene expression markers of lipolysis, glucose and lipid metabolism and inflammation', 'adipose tissue vasculature and decreased CD36']","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0206131', 'cui_str': 'Adipocyte'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0015688', 'cui_str': 'Unesterified fatty acid'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0054954', 'cui_str': 'Lymphocyte antigen CD36'}]",,0.0307792,"RESULTS


Training increased glucose uptake in VAT (p<0.001) and femoral SAT (p<0.001) and decreased fatty acid uptake in VAT (p=0.01) irrespective of baseline glucose tolerance and sex.","[{'ForeName': 'Sanna Maria', 'Initials': 'SM', 'LastName': 'Honkala', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Piryanka', 'Initials': 'P', 'LastName': 'Motiani', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Riikka', 'Initials': 'R', 'LastName': 'Kivelä', 'Affiliation': 'Stem Cells and Metabolism Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Karthik Amudhala', 'Initials': 'KA', 'LastName': 'Hemanthakumar', 'Affiliation': 'Stem Cells and Metabolism Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Tolvanen', 'Affiliation': 'Stem Cells and Metabolism Research Program, Faculty of Medicine, University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'Kumail Kumar', 'Initials': 'KK', 'LastName': 'Motiani', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Jari-Joonas', 'Initials': 'JJ', 'LastName': 'Eskelinen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Kirsi A', 'Initials': 'KA', 'LastName': 'Virtanen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Jukka', 'Initials': 'J', 'LastName': 'Kemppainen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Marja Anneli', 'Initials': 'MA', 'LastName': 'Heiskanen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Eliisa', 'Initials': 'E', 'LastName': 'Löyttyniemi', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Nuutila', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Kari K', 'Initials': 'KK', 'LastName': 'Kalliokoski', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland.'}, {'ForeName': 'Jarna Christina', 'Initials': 'JC', 'LastName': 'Hannukainen', 'Affiliation': 'Turku PET Centre, University of Turku, Turku, Finland jarna.hannukainen@tyks.fi.'}]",BMJ open diabetes research & care,['10.1136/bmjdrc-2019-000830']
2771,32825378,Effects of Six Weeks of High-Intensity Functional Training on Physical Performance in Participants with Different Training Volumes and Frequencies.,"High-intensity functional training (HIFT) is characterized by presenting high volumes and training intensities with constantly varied exercises. The aim of this study was to analyze the internal training load and the effects of high-intensity functional training on physical performance in subjects with different training volumes and frequencies. A total of 31 volunteers involved in high-intensity functional training (14 men and 17 women) were divided according to their training volumes and frequencies (high training-volume and frequency-HTVF; ( n  = 17) (nine women and eight men; age: 31.0 ± 6.3 years; height: 168.8 ± 8.1 cm, body weight: 73.6 ± 11.9 kg; BMI: 25.96 kg/m 2 ) and moderate training volume and frequency-MTVF; ( n  = 14) (eight women and six men; age: 26.6 ± 4.7 years; height: 167.2 ± 8.6 cm, body weight: 75.8 ± 18.0 kg; BMI: 27.33 kg/m 2 )). The internal training load was determined using the session-rating of perceived exertion method. The monotony index (MI) and training strain (TS) were used to determine training variability during the training weeks. Countermovement vertical jump height, 20-m sprinting and handgrip strength were assessed at baseline and after six weeks of training. There was a time effect for MI ((F (5, 145)  = 5.942;  p  = 0.0001)), TS ((F (5, 145)  = 5.734;  p  = 0.0001)), weekly internal training load ((F (4.006, 116.87)  = 4.188;  p  = 0.003)) and mean weekly internal training load ((F (4.006, 116.87)  = 4.188;  p  = 0.003)). There was no increase in performance in either group for countermovement vertical jump height ((F (1,29)  = 6.081;  p  = 0.050)), sprinting ((F (1,29)  = 1.014;  p  = 0.322)), right handgrip strength ((F (1,29)  = 2.522;  p  = 0.123)) or left handgrip strength ((F (1,29)  = 2.550;  p  = 0.121)). The current findings suggest that six weeks of high-intensity functional training was not able to increase performance in either group. Therefore, different volumes and frequencies do not seem to influence the increase in physical performance of HIFT practitioners.",2020,"There was no increase in performance in either group for countermovement vertical jump height ((F (1,29)  = 6.081;  p  = 0.050)), sprinting ((F (1,29)  = 1.014;  p  = 0.322)), right handgrip strength ((F (1,29)  = 2.522;  p  = 0.123)) or left handgrip strength ((F (1,29)  = 2.550;  p  = 0.121)).","['Participants with Different Training Volumes and Frequencies', ' n  = 17) (nine women and eight men; age: 31.0 ± 6.3 years; height: 168.8 ± 8.1 cm, body weight: 73.6 ± 11.9 kg; BMI: 25.96 kg/m 2 ) and moderate training volume and frequency-MTVF; ( n  = 14) (eight women and six men; age: 26.6 ± 4.7 years; height: 167.2 ± 8.6 cm, body weight: 75.8 ± 18.0 kg; BMI: 27.33 kg/m 2 ', 'subjects with different training volumes and frequencies', '31 volunteers involved in high-intensity functional training (14 men and 17 women']","['training volumes and frequencies (high training-volume and frequency-HTVF', 'High-Intensity Functional Training', 'high-intensity functional training', 'High-intensity functional training (HIFT']","['weekly internal training load', 'performance', 'countermovement vertical jump height', 'right handgrip strength', 'monotony index (MI) and training strain (TS', 'mean weekly internal training load', 'Countermovement vertical jump height, 20-m sprinting and handgrip strength', 'physical performance', 'left handgrip strength', 'Physical Performance']","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205091', 'cui_str': 'Left'}]",31.0,0.0237396,"There was no increase in performance in either group for countermovement vertical jump height ((F (1,29)  = 6.081;  p  = 0.050)), sprinting ((F (1,29)  = 1.014;  p  = 0.322)), right handgrip strength ((F (1,29)  = 2.522;  p  = 0.123)) or left handgrip strength ((F (1,29)  = 2.550;  p  = 0.121)).","[{'ForeName': 'Rômulo Vasconcelos', 'Initials': 'RV', 'LastName': 'Teixeira', 'Affiliation': 'Graduate Program on Physical Education, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte 59072970, Brazil.'}, {'ForeName': 'Gilmário Ricarte', 'Initials': 'GR', 'LastName': 'Batista', 'Affiliation': 'Department of Physical Education, Federal University of Paraíba, João Pessoa, Paraíba 58051900, Brazil.'}, {'ForeName': 'Arnaldo Luis', 'Initials': 'AL', 'LastName': 'Mortatti', 'Affiliation': 'Graduate Program on Physical Education, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte 59072970, Brazil.'}, {'ForeName': 'Paulo Moreira Silva', 'Initials': 'PMS', 'LastName': 'Dantas', 'Affiliation': 'Graduate Program on Physical Education, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte 59072970, Brazil.'}, {'ForeName': 'Breno Guilherme de Araújo Tinôco', 'Initials': 'BGAT', 'LastName': 'Cabral', 'Affiliation': 'Graduate Program on Physical Education, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte 59072970, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17176058']
2772,32825509,Continuous Compared to Accumulated Walking-Training on Physical Function and Health-Related Quality of Life in Sedentary Older Persons.,"The present study aimed to analyze the impact of overground walking interval training (WIT) in a group of sedentary older adults, comparing two different dose-distributions. In this quasi-experimental and longitudinal study, we recruited twenty-three sedentary older adults (71.00 ± 4.10 years) who were assigned to two groups of WIT. The continuous group (CWIT) trained for 60 min/session in the morning, while the accumulated group (AWIT) performed the same duration and intensity of exercise, but it was distributed twice a day (30 min in the morning and 30 more in the afternoon). After 15 weeks of an equal external-load training (3 days/week), Bonferroni post-hoc comparisons revealed significant ( p  < 0.050) and similar large improvements in both groups in cardiorespiratory fitness and lower limb strength; even larger gains in preferred walking speed and instrumental daily life activity, which was slightly superior for CWIT; and improvements in agility, which were moderate for CWIT and large for AWIT. However, none of the training protocols had an impact on the executive function in the individuals, and only the AWIT group improved health-related quality of life. Although both training protocols induced a general significant improvement in physical function in older adults, our results showed that the accumulative strategy should be recommended when health-related quality of life is the main target, and the continuous strategy should be recommended when weakness may be a threat in the short or medium term.",2020,"However, none of the training protocols had an impact on the executive function in the individuals, and only the AWIT group improved health-related quality of life.","['twenty-three sedentary older adults (71.00 ± 4.10 years) who were assigned to two groups of WIT', 'older adults', 'Sedentary Older Persons', 'a group of sedentary older adults']","['Accumulated Walking-Training', 'overground walking interval training (WIT']","['Physical Function and Health-Related Quality of Life', 'physical function', 'walking speed and instrumental daily life activity', 'health-related quality of life', 'executive function', 'cardiorespiratory fitness and lower limb strength']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0441835', 'cui_str': 'Group A'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",23.0,0.0179847,"However, none of the training protocols had an impact on the executive function in the individuals, and only the AWIT group improved health-related quality of life.","[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Monteagudo', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Ainoa', 'Initials': 'A', 'LastName': 'Roldán', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Cordellat', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Mari Carmen', 'Initials': 'MC', 'LastName': 'Gómez-Cabrera', 'Affiliation': 'Freshage Research Group, Department of Physiology, faculty of Medicine, University of Valencia, CIBERFES, Fundación Investigación Hospital Clínico Universitario/INCLIVA, 46010 Valencia, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Sport Performance and Physical Fitness Research Group (UIRFIDE), University of Valencia, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17176060']
2773,32825535,Physical Activity Counseling for Adults with Hypertension: A Randomized Controlled Pilot Trial.,"The effect of physical activity counseling (PAC) in hypertensive adults is unclear. This study investigated the effect of PAC on blood pressure (BP), physical activity level, sitting time, metabolic profile, and body composition in hypertensive adults. Twenty-two hypertensive adults (48.8 ± 7.3 years) participated in this pilot trial. The 12-week PAC was based on the 5 A's model considering the FITT principle (Frequency, Intensity, Time, and Type) of physical activity. The control group received instructions about FITT in one face-to-face meeting at baseline. Pedometer-measured physical activity, sitting time, resting and ambulatory BP, metabolic profile (cholesterol, triglycerides, fasting glucose), and body composition (fat mass, abdominal fat, fat free mass) were assessed. The PAC group showed higher steps per day (5839 ± 992 vs. 5028 ± 902;  p  = 0.044) and a trend for lower sitting time (5.6 ± 1.3 vs. 8.0 ± 4.0 h/day;  p  = 0.059) than the control group. No changes were observed in BP, metabolic profile, and body composition ( p >  0.05). In conclusion, 12 weeks of a PAC program based on the 5 A's model resulted in a modest increase of ~800 steps per day and a trend to decrease ~2 h/day in sitting time, but there were no associated reduction in BP and improvements in metabolic and body composition.",2020,The PAC group showed higher steps per day (5839 ± 992 vs. 5028 ± 902;  p  = 0.044) and a trend for lower sitting time (5.6 ± 1.3 vs. 8.0 ± 4.0 h/day;  p  = 0.059) than the control group.,"['Adults with Hypertension', 'Twenty-two hypertensive adults (48.8 ± 7.3 years', 'hypertensive adults']","['physical activity counseling (PAC', 'Physical Activity Counseling', 'PAC', 'instructions about FITT']","['Pedometer-measured physical activity, sitting time, resting and ambulatory BP, metabolic profile (cholesterol, triglycerides, fasting glucose), and body composition (fat mass, abdominal fat, fat free mass', 'BP and improvements in metabolic and body composition', 'lower sitting time', 'blood pressure (BP), physical activity level, sitting time, metabolic profile, and body composition', 'BP, metabolic profile, and body composition']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0060398', 'cui_str': 'FITT'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",22.0,0.0226444,The PAC group showed higher steps per day (5839 ± 992 vs. 5028 ± 902;  p  = 0.044) and a trend for lower sitting time (5.6 ± 1.3 vs. 8.0 ± 4.0 h/day;  p  = 0.059) than the control group.,"[{'ForeName': 'Altieres E', 'Initials': 'AE', 'LastName': 'Sousa Junior', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}, {'ForeName': 'Geovani A D', 'Initials': 'GAD', 'LastName': 'Macêdo', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schwade', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}, {'ForeName': 'Júlio', 'Initials': 'J', 'LastName': 'Sócrates', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Rio Grande do Norte, Natal 59012-570, RN, Brazil.'}, {'ForeName': 'José W', 'Initials': 'JW', 'LastName': 'Alves', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}, {'ForeName': 'Luiz F', 'Initials': 'LF', 'LastName': 'Farias-Junior', 'Affiliation': 'Graduate Program in Psychobiology, Federal University of Rio Grande do Norte, Natal 59064-741, RN, Brazil.'}, {'ForeName': 'Yuri A', 'Initials': 'YA', 'LastName': 'Freire', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}, {'ForeName': 'Telma M A M', 'Initials': 'TMAM', 'LastName': 'Lemos', 'Affiliation': 'Department of Clinical and Toxicological Analysis, Federal University of Rio Grande do Norte, Natal 59012-570, RN, Brazil.'}, {'ForeName': 'Rodrigo A V', 'Initials': 'RAV', 'LastName': 'Browne', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Rio Grande do Norte, Natal 59012-570, RN, Brazil.'}, {'ForeName': 'Eduardo C', 'Initials': 'EC', 'LastName': 'Costa', 'Affiliation': 'Graduate Program in Physical Education, Federal University of Rio Grande do Norte, Natal 59072-970, RN, Brazil.'}]",International journal of environmental research and public health,['10.3390/ijerph17176076']
2774,32825555,Beneficial Effects of Interactive Physical-Cognitive Game-Based Training on Fall Risk and Cognitive Performance of Older Adults.,"Physical and cognitive declines are significant risk factors for falls. Promising evidence suggests that combined physical-cognitive training would be an effective fall risk reduction and cognitive improvement intervention. However, a limited number of studies have been conducted and findings have been inconclusive. This study investigated the effects of interactive physical-cognitive game-based training on the fall risk and cognitive performance of older adults. Forty participants were randomly allocated to the intervention (n = 20) and control (n = 20) groups. Participants in the intervention group performed a 1 h session, 3 times a week for 12 weeks of the interactive physical-cognitive game-based training program. Fall risk (Physiological Profile Assessment, PPA; and Timed Up and Go, TUG) and cognitive outcome (Montreal Cognitive Assessment, MoCA) were assessed at pre- and post-intervention. Thirty-nine participants (mean age = 69.81 ± 3.78 years) completed the study (97.5%). At the end of the trial, participants in the intervention group demonstrated significant improvement in the PPA fall risk score ( p  = 0.015), postural sway ( p  = 0.005), MoCA score ( p  = 0.001), and TUG-dual task ( p  = 0.045) compared to controls. In conclusion, the interactive physical-cognitive, game-based training was effective in reducing physiological fall risk and improving cognitive function in community-dwelling older adults.",2020,"At the end of the trial, participants in the intervention group demonstrated significant improvement in the PPA fall risk score ( p  = 0.015), postural sway ( p  = 0.005), MoCA score ( p  = 0.001), and TUG-dual task ( p  = 0.045) compared to controls.","['Older Adults', 'older adults', 'community-dwelling older adults', 'Thirty-nine participants (mean age = 69.81 ± 3.78 years) completed the study (97.5', 'Forty participants']","['Interactive Physical-Cognitive Game-Based Training', 'interactive physical-cognitive game-based training program', 'interactive physical-cognitive game-based training', 'interactive physical-cognitive, game-based training', 'combined physical-cognitive training']","['Fall risk (Physiological Profile Assessment, PPA; and Timed Up and Go, TUG) and cognitive outcome (Montreal Cognitive Assessment, MoCA', 'MoCA score', 'TUG-dual task', 'PPA fall risk score', 'fall risk and cognitive performance', 'Fall Risk and Cognitive Performance', 'physiological fall risk and improving cognitive function', 'postural sway']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C1268740', 'cui_str': 'At risk for falls'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031495', 'cui_str': 'Phenylpropanolamine'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0205278', 'cui_str': 'Postural'}]",40.0,0.0128531,"At the end of the trial, participants in the intervention group demonstrated significant improvement in the PPA fall risk score ( p  = 0.015), postural sway ( p  = 0.005), MoCA score ( p  = 0.001), and TUG-dual task ( p  = 0.045) compared to controls.","[{'ForeName': 'Kochaphan', 'Initials': 'K', 'LastName': 'Phirom', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Teerawat', 'Initials': 'T', 'LastName': 'Kamnardsiri', 'Affiliation': 'Department of Digital Game, College of Arts, Media, and Technology, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Somporn', 'Initials': 'S', 'LastName': 'Sungkarat', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai 50200, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph17176079']
2775,32825556,"Acute Epigallocatechin-3-Gallate Supplementation Alters Postprandial Lipids after a Fast-Food Meal in Healthy Young Women: A Randomized, Double-Blind, Placebo-Controlled Crossover Study.","A high-fat fast-food meal negatively impacts postprandial metabolism even in healthy young people. In experimental studies, epigallocatechin-3-gallate (EGCG), a bioactive compound present in green tea, has been described as a potent natural inhibitor of fatty acid synthase. Thus, we sought to evaluate the effects of acute EGCG supplementation on postprandial lipid profile, glucose, and insulin levels following a high-fat fast-food meal. Fourteen healthy young women 21 ± 1 years and body mass index 21.4 ± 0.41 kg/m 2  were enrolled in a randomized, double-blind, placebo-controlled crossover study. Participants ingested capsules containing 800 mg EGCG or placebo immediately before a typical fast-food meal rich in saturated fatty acids. Blood samples were collected at baseline and then at 90 and 120 min after the meal. The EGCG treatment attenuated postprandial triglycerides ( p  = 0.029) and decreased high-density lipoprotein cholesterol (HDL-c) ( p  = 0.016) at 120 min. No treatment × time interaction was found for total cholesterol, low-density lipoprotein (LDL-c), and glucose or insulin levels. The incremental area under the curve (iAUC) for glucose was decreased by EGCG treatment ( p  < 0.05). No difference was observed in the iAUC for triglycerides and HDL-c. In healthy young women, acute EGCG supplementation attenuated postprandial triglycerides and glucose but negatively impacted HDL-c following a fast-food meal.",2020,"No treatment × time interaction was found for total cholesterol, low-density lipoprotein (LDL-c), and glucose or insulin levels.","['Healthy Young Women', 'healthy young people', 'Fourteen healthy young women 21 ± 1 years and body mass index 21.4 ± 0.41 kg/m 2', 'healthy young women']","['Placebo', 'EGCG', 'acute EGCG supplementation', 'EGCG or placebo', 'epigallocatechin-3-gallate (EGCG', 'Acute Epigallocatechin-3-Gallate Supplementation', 'placebo']","['incremental area under the curve (iAUC) for glucose', 'high-density lipoprotein cholesterol (HDL-c', 'iAUC for triglycerides and HDL-c', 'postprandial triglycerides', 'Blood samples', 'postprandial lipid profile, glucose, and insulin levels', 'total cholesterol, low-density lipoprotein (LDL-c), and glucose or insulin levels', 'postprandial triglycerides and glucose']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",14.0,0.329711,"No treatment × time interaction was found for total cholesterol, low-density lipoprotein (LDL-c), and glucose or insulin levels.","[{'ForeName': 'Alcides C', 'Initials': 'AC', 'LastName': 'de Morais Junior', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goiás (UFG), Goiania 74690-900, GO, Brazil.'}, {'ForeName': 'Raquel M', 'Initials': 'RM', 'LastName': 'Schincaglia', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goiás (UFG), Goiania 74690-900, GO, Brazil.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Passarelli', 'Affiliation': 'Laboratório de Lípides (LIM 10), Hospital das Clínicas (HCFMUSP), Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo 05403-900, Brazil.'}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Pimentel', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goiás (UFG), Goiania 74690-900, GO, Brazil.'}, {'ForeName': 'João F', 'Initials': 'JF', 'LastName': 'Mota', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (LABINCE), Faculty of Nutrition, Federal University of Goiás (UFG), Goiania 74690-900, GO, Brazil.'}]",Nutrients,['10.3390/nu12092533']
2776,32825565,The Prototypes of Tobacco Users Scale (POTUS) for Cigarette Smoking and E-Cigarette Use: Development and Validation.,"Endorsing prototypes of cigarette smokers predicts cigarette smoking, but less is known about prototypes of users of other tobacco products. Our study sought to establish the reliability and validity of a measure of prototypes of smokers and e-cigarette users. Participants were from a national survey of smokers and non-smokers ( n  = 1414), a randomized clinical trial (RCT) of adult smokers ( n  = 2149), and adolescent children of adults in the trial ( n  = 112). The Prototypes of Tobacco Users Scale (POTUS) has four positive adjectives (cool, sexy, smart, and healthy) and four negative adjectives (disgusting, unattractive, immature, and inconsiderate) describing cigarette smokers and e-cigarette users. Confirmatory factor analyses identified a two-factor solution. The POTUS demonstrated strong internal consistency reliability in all three samples (median α = 0.85) and good test-retest reliability among adults in the RCT (median r = 0.61, 1-4 weeks follow-up). In the RCT, smokers more often agreed with negative prototypes for smokers than for e-cigarette users (mean = 2.03 vs. 1.67,  p  < 0.05); negative prototypes at baseline were also associated with more forgoing of cigarettes and making a quit attempt at the end of the trial (Week 4 follow-up). The POTUS may be useful to public health researchers seeking to design interventions that reduce tobacco initiation or cessation through the manipulation of tobacco user prototypes.",2020,"The POTUS demonstrated strong internal consistency reliability in all three samples (median α = 0.85) and good test-retest reliability among adults in the RCT (median r = 0.61, 1-4 weeks follow-up).","['smokers and e-cigarette users', 'Participants were from a national survey of smokers and non-smokers ( n  = 1414), a randomized clinical trial (RCT) of adult smokers ( n  = 2149), and adolescent children of adults in the trial ( n  = 112']",[],['internal consistency reliability'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4505216', 'cui_str': 'Electronic cigarette user'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319548', 'cui_str': '112'}]",[],"[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}]",,0.0224771,"The POTUS demonstrated strong internal consistency reliability in all three samples (median α = 0.85) and good test-retest reliability among adults in the RCT (median r = 0.61, 1-4 weeks follow-up).","[{'ForeName': 'Eboneé N', 'Initials': 'EN', 'LastName': 'Butler', 'Affiliation': 'Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599 USA.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Lineberger Comprehensive Cancer Center, Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'May S', 'Initials': 'MS', 'LastName': 'Chen', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Pepper', 'Affiliation': 'RTI International, Research Triangle Park, NC 27709, USA.'}, {'ForeName': 'Hart', 'Initials': 'H', 'LastName': 'Blanton', 'Affiliation': 'Department of Communication, Texas A&M University, College Station, TX 77843, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Lineberger Comprehensive Cancer Center, Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17176081']
2777,32825588,TILs Immunophenotype in Breast Cancer Predicts Local Failure and Overall Survival: Analysis in a Large Radiotherapy Trial with Long-Term Follow-Up.,"AIM


To determine the prognostic significance of the immunophenotype of tumour-infiltrating lymphocytes (TILs) within a cohort of breast cancer patients with long-term follow-up.
METHODS


Multiplexed immunofluorescence and automated image analysis were used to assess the expression of CD3, CD8, CD20, CD68, Fox P3, PD-1 and PD-L1 in a clinical trial of local excision and radiotherapy randomised to a cavity boost or not ( n  = 485, median follow-up 16 years). Kaplan-Meier and Cox multivariate analysis (MVA) methodology were used to ascertain relationships with local recurrence (LR), overall survival (OS) and disease-free survival (DFS). NanoString BC360 gene expression panel was applied to a subset of luminal patients to identify pathways associated with LR.
RESULTS


LR was predicted by low CD8 in MVA in the whole cohort (HR 2.34, CI 1.4-4.02,  p  = 0.002) and luminal tumours (HR 2.19, CI 1.23-3.92,  p  = 0.008) with associations with increased stromal components, decreased Tregs (FoxP3), inflammatory chemokines and SOX2. Poor OS was associated with low CD20 in the whole cohort (HR 1.73, CI 1.2-2.4,  p  = 0.002) and luminal tumours on MVA and low PD-L1 in triple-negative cancer (HR 3.44, CI 1.5-7,  p  = 0.003).
CONCLUSIONS


Immunophenotype adds further prognostic data to help further stratify risk of LR and OS even in TILs low-luminal tumours.",2020,"Poor OS was associated with low CD20 in the whole cohort (HR 1.73, CI 1.2-2.4,  p  = 0.002) and luminal tumours on MVA and low PD-L1 in triple-negative cancer (HR 3.44, CI 1.5-7,  p  = 0.003).
",['breast cancer patients with long-term'],"['Immunophenotype', 'local excision and radiotherapy']","['local recurrence (LR), overall survival (OS) and disease-free survival (DFS', 'luminal tumours', 'Poor OS', 'low CD8 in MVA', 'expression of CD3, CD8, CD20, CD68, Fox P3, PD-1 and PD-L1', 'stromal components, decreased Tregs (FoxP3), inflammatory chemokines and SOX2']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0079611', 'cui_str': 'Immunophenotyping'}, {'cui': 'C0278259', 'cui_str': 'Local excision'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0052712', 'cui_str': 'AVM protocol'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0108779', 'cui_str': 'Lymphocyte antigen CD3'}, {'cui': 'C0054946', 'cui_str': 'Lymphocyte antigen CD20'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}, {'cui': 'C0016632', 'cui_str': 'Fox-Fordyce disease'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C1568630', 'cui_str': 'SOX2 protein, human'}]",,0.133403,"Poor OS was associated with low CD20 in the whole cohort (HR 1.73, CI 1.2-2.4,  p  = 0.002) and luminal tumours on MVA and low PD-L1 in triple-negative cancer (HR 3.44, CI 1.5-7,  p  = 0.003).
","[{'ForeName': 'Ewan', 'Initials': 'E', 'LastName': 'Millar', 'Affiliation': 'Department of Anatomical Pathology, NSW Health Pathology, St George Hospital, Kogarah, NSW 2217, Australia.'}, {'ForeName': 'Lois', 'Initials': 'L', 'LastName': 'Browne', 'Affiliation': 'Cancer Care Centre, St George Hospital, Kogarah, NSW 2217, Australia.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Slapetova', 'Affiliation': 'Biomedical Imaging Facility, Mark Wainwright Analytical Centre, University of New South Wales Sydney, Kensington, NSW 2052, Australia.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shang', 'Affiliation': 'Biomedical Imaging Facility, Mark Wainwright Analytical Centre, University of New South Wales Sydney, Kensington, NSW 2052, Australia.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Ren', 'Affiliation': 'NanoString Technologies Inc., Seattle, WA 98109, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Bradshaw', 'Affiliation': 'NanoString Technologies Inc., Seattle, WA 98109, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Ann Brauer', 'Affiliation': 'NanoString Technologies Inc., Seattle, WA 98109, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': ""O'Toole"", 'Affiliation': 'Department of Anatomical Pathology, NSW Health Pathology, Royal Prince Alfred Hospital, Camperdown, NSW 2217, Australia.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Beretov', 'Affiliation': 'Department of Anatomical Pathology, NSW Health Pathology, St George Hospital, Kogarah, NSW 2217, Australia.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Whan', 'Affiliation': 'Biomedical Imaging Facility, Mark Wainwright Analytical Centre, University of New South Wales Sydney, Kensington, NSW 2052, Australia.'}, {'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Graham', 'Affiliation': 'Faculty of Medicine, St George & Sutherland Clinical School, University of New South Wales Sydney, Kensington, NSW 2052, Australia.'}]",Cancers,['10.3390/cancers12092365']
2778,32825977,Persian manual therapy method for chronic low-back pain with lumbar radiculopathy; a randomized controlled trial.,"BACKGROUND


Manual therapy is a non-surgical approach for management of musculoskeletal symptoms. This study investigated safety and efficacy of a Persian manual therapy method (Fateh technique) for management of chronic low-back pain (LBP) and radiculopathy.
METHODS


In this controlled trial, 52 eligible patients with chronic LBP and lumbar radiculopathy were randomly assigned into two intervention groups; one received a 16-min soft tissue manipulation for four weekly sessions and did two daily home active exercises. The other group only did the two daily exercises for four weeks. Roland-Morris disability score, Visual Analogue Scale scores of LBP, radiculopathy and paresthesia, and finger-to-floor test result were assessed at the baseline, and in fourth and eighth weeks of trial.
RESULTS


Data of 48 participants was analyzed. Distributions of age, sex, and duration of symptoms in two groups were the same. Fateh technique respectively decreased pain, radiculopathy, paresthesia, and disability, by 4.28 [95% confidence interval: 3.36-5.19], 3.85 [2.67-5.03], 1.32 [0.37-2.27], and 4.58 [3.23-5.93] units, and increased body flexibility by 35.42 [6.91-63.92] millimeters. Compared with home exercise, Fateh technique was associated with greater changes in all outcomes. No adverse event has occurred.
CONCLUSIONS


Fateh technique is safe and effective for management of LBP and radiculopathy in patients without severe progressive symptoms.",2020,"Fateh technique respectively decreased pain, radiculopathy, paresthesia, and disability, by 4.28 [95% confidence interval: 3.36-5.19], 3.85 [2.67-5.03], 1.32 [0.37-2.27], and 4.58 [3.23-5.93] units, and increased body flexibility by 35.42 [6.91-63.92] millimeters.","['52 eligible patients with chronic LBP and lumbar radiculopathy', 'chronic low-back pain with lumbar radiculopathy', '48 participants was analyzed', 'patients without severe progressive symptoms']","['16-min soft tissue manipulation for four weekly sessions and did two daily home active exercises', 'Persian manual therapy method (Fateh technique']","['pain, radiculopathy, paresthesia, and disability', 'Roland-Morris disability score, Visual Analogue Scale scores of LBP, radiculopathy and paresthesia, and finger-to-floor test result', 'safety and efficacy', 'body flexibility']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C1263855', 'cui_str': 'Lumbar radiculopathy'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0419117', 'cui_str': 'Active exercise'}, {'cui': 'C0031188', 'cui_str': 'Persian language'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0456984', 'cui_str': 'Test finding'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",52.0,0.117942,"Fateh technique respectively decreased pain, radiculopathy, paresthesia, and disability, by 4.28 [95% confidence interval: 3.36-5.19], 3.85 [2.67-5.03], 1.32 [0.37-2.27], and 4.58 [3.23-5.93] units, and increased body flexibility by 35.42 [6.91-63.92] millimeters.","[{'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Sanei', 'Affiliation': 'Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzin', 'Initials': 'F', 'LastName': 'Roozafzai', 'Affiliation': 'Digestive Disease Research Institute, Shariati Hopital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shobeir Rostami', 'Initials': 'SR', 'LastName': 'Abousaidi', 'Affiliation': 'Department of Orthopedics, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Hamze', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir-Masoud', 'Initials': 'AM', 'LastName': 'Negarestani', 'Affiliation': 'Department of Radiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Mokaberinejad', 'Affiliation': 'Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: rmokaberi@gmail.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.015']
2779,32825981,A randomized clinical trial for the effect of static stretching and strengthening exercise on pelvic tilt angle in LBP patients.,"BACKGROUND


Stretching and strengthening exercises are commonly used to improve muscle shortness of the hamstring as any tension in this muscle can have an effect on the pelvic posture. Thus, the aim of this study was to evaluate the effects of two methods of improving short hamstring on the angle of pelvic tilt in LBP sufferers.
METHODS


Forty-five low back pain patients aged 19-59 years with hamstring tightness participated in this clinical trial. The patients were categorized randomly into three groups: 1- static stretching, 2-strengthening exercise and 3-control group. The two intervention groups received physical therapy and special exercise program thrice a week in a total of 12 sessions, while the control group received only conventional physical therapy. Before and after the treatment implementation, the pelvic tilt and straight leg raising (SLR) degree were assessed for each group.
RESULT


After 12 sessions of treatment, the ANCOVA models indicated non-significant differences in pelvic tilt angle and SLR score changes (p > 0.05), among the three groups. In addition, no statistically significant correlation was observed between the pelvic tilt and SLR test [except for the strengthening exercise group (Pearson correlation coefficient = -0.54, P < 0.05)].
CONCLUSIONS


In LBP sufferers, both static stretching and strengthening of hamstring muscle in its lengthened position caused elongation and extensibility in the hamstring muscle and increased SLR test score, but did not change pelvic tilt angle.",2020,"After 12 sessions of treatment, the ANCOVA models indicated non-significant differences in pelvic tilt angle and SLR score changes (p > 0.05), among the three groups.","['LBP patients', 'Forty-five low back pain patients aged 19-59 years with hamstring tightness participated in this clinical trial', 'LBP sufferers']","['strengthening exercise', 'physical therapy and special exercise program', '1- static stretching, 2-strengthening exercise and 3-control group', 'control group received only conventional physical therapy', 'static stretching and strengthening exercise', 'Stretching and strengthening exercises']","['pelvic tilt angle', 'pelvic tilt and straight leg raising (SLR) degree', 'pelvic tilt and SLR test', 'pelvic tilt angle and SLR score changes', 'SLR test score']","[{'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439816', 'cui_str': 'Tightness sensation quality'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}]","[{'cui': 'C1629036', 'cui_str': 'Pelvic declination'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",45.0,0.0207692,"After 12 sessions of treatment, the ANCOVA models indicated non-significant differences in pelvic tilt angle and SLR score changes (p > 0.05), among the three groups.","[{'ForeName': 'MohammadBagher', 'Initials': 'M', 'LastName': 'Shamsi', 'Affiliation': 'Rehabilitation and Sport Medicine Department, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: mbshamsi@yahoo.com.'}, {'ForeName': 'Soodeh', 'Initials': 'S', 'LastName': 'Shahsavari', 'Affiliation': 'Health Information Management Department, Faculty of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: soodeh_shahsavari@yahoo.com.'}, {'ForeName': 'Ameneh', 'Initials': 'A', 'LastName': 'Safari', 'Affiliation': 'Research Management Office, Faculty of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: safari.ameneh0@gmail.com.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Mirzaei', 'Affiliation': 'Faculty of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: maryam.mirzaee@kums.ac.ir.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.001']
2780,32825982,Effects of non-linear resistance training and curcumin supplementation on the liver biochemical markers levels and structure in older women with non-alcoholic fatty liver disease.,"BACKGROUND


With increasing age, non-alcoholic fatty liver disease is very common among women with low levels of physical activity. Nonlinear resistance training is one of the new methods to help patients who have low levels of physical activity. Curcumin is an herbal supplement that has anti-inflammatory effects. The present study aimed to examine the effects of nonlinear resistance training and curcumin supplementation on the liver structure and biochemical markers in obese older women with non-alcoholic fatty liver disease.
METHODS


Forty-five obese women with non-alcoholic fatty liver disease were randomly assigned into resistance training (RT), curcumin supplement (C), resistance training with curcumin supplement (RTC), and placebo (P) groups. The RT and RTC groups received 12-weeks of nonlinear resistance training while the C and P groups had a normal sedentary lifestyle. Daily, the C and RTC groups received a curcumin capsule while the P and RT groups were given a placebo capsule. Blood sampling and ultrasonography were taken before and after the protocol.
RESULTS


Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels significantly decreased in the RT and RTC groups (P ≤ 0.05) but not in the C and P groups (P > 0.05). Alkaline phosphatase (ALP), total bilirubin (TB) levels, platelet counts (PLT), and liver structure did not significantly change in all groups (P > 0.05). Resistance training alone and with curcumin supplementation could significantly improve liver function while taking curcumin alone did not have any significant effect on it.
CONCLUSION


12-week non-linear resistance training has beneficial effects on non-alcoholic fatty liver disease in older obese women.",2020,"Resistance training alone and with curcumin supplementation could significantly improve liver function while taking curcumin alone did not have any significant effect on it.
","['women with low levels of physical activity', 'Forty-five obese women with non-alcoholic fatty liver disease', 'older women with non-alcoholic fatty liver disease', 'older obese women', 'obese older women with non-alcoholic fatty liver disease']","['non-linear resistance training and curcumin supplementation', 'Resistance training alone and with curcumin supplementation', 'resistance training (RT), curcumin supplement (C), resistance training with curcumin supplement (RTC), and placebo', 'Nonlinear resistance training', 'nonlinear resistance training and curcumin supplementation', 'linear resistance training', 'nonlinear resistance training']","['Alkaline phosphatase (ALP), total bilirubin (TB) levels, platelet counts (PLT), and liver structure', 'liver function', 'Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels', 'liver structure and biochemical markers']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}]",45.0,0.113311,"Resistance training alone and with curcumin supplementation could significantly improve liver function while taking curcumin alone did not have any significant effect on it.
","[{'ForeName': 'Baharak', 'Initials': 'B', 'LastName': 'Moradi Kelardeh', 'Affiliation': 'Phd Exercise Physiology, Sama Technical and Vocational Training College, Islamic Azad University, Esfahan (Khorasgan) Branch, Esfahan, Iran.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Rahmati-Ahmadabad', 'Affiliation': 'Department of Physical Education, Pardis Branch, Islamic Azad University, Pardis, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Farzanegi', 'Affiliation': 'Department of Exercise Physiology, Sari Branch, Islamic Azad University, Sari, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Helalizadeh', 'Affiliation': 'Department of Exercise Physiology, Sport Medicine Research Center, Sport Sciences Research Institute, Tehran, Iran.'}, {'ForeName': 'Mohammad-Ali', 'Initials': 'MA', 'LastName': 'Azarbayjani', 'Affiliation': 'Department of Exercise Physiology, Central Tehran Branch, Islamic Azad University, Tehran, Iran. Electronic address: m_azarbayjani@iauctb.ac.ir.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.021']
2781,32825983,Treatment of panic disorder by trigeminal nerve manipulation: A case series.,"This is a report on two cases of patients with acute severe panic disorder relieved of their symptoms by manual manipulations of the trigeminal nerve's alveolar branches. The manipulations were performed via the oral cavity during one session, or two consecutive sessions less than a week apart. No other effective treatment was administered prior, concurrently or since the time of the treatment. The recovery from panic disorder was immediate and lasted for the entire period of observation of three years. The authors used the same procedure and achieved identical clinical results treating ten other clients over a period of three years. This was not a planned experiment or randomized study. Rather, this report presents clinical evidence and the authors' hypothesis based on clinical data and literature review.",2020,The recovery from panic disorder was immediate and lasted for the entire period of observation of three years.,['patients with acute severe panic disorder'],['trigeminal nerve manipulation'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}]","[{'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}]",[],10.0,0.0143006,The recovery from panic disorder was immediate and lasted for the entire period of observation of three years.,"[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Birstein', 'Affiliation': 'Pittsburgh Integrative Mental Health, 160 N. Craig St. Suite 212 Pittsburgh, PA, 15213, USA. Electronic address: birstein@gmail.com.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Gusky', 'Affiliation': 'Pittsburgh Integrative Mental Health, 160 N. Craig St. Suite 212 Pittsburgh, PA, 15213, USA.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.01.002']
2782,32825989,Osteopathic treatment leads to significantly greater reductions in chronic thoracic pain after CABG surgery: A randomised controlled trial.,"BACKGROUND


There are a number of long-term postoperative complications after coronary artery bypass graft (CABG) surgery. Pulmonary function is decreased by 12% and 30%-50% of the patients have chronic thoracic pain.
METHODS


This randomised controlled trial with two parallel groups aimed to explore the effectiveness of osteopathic treatments (OTs) on these conditions. The standard care (SC) group and the and OT group received a 12-week standard cardiac rehabilitation programme, which was supplemented with four OTs for the OT group only. The outcome assessors were blinded to the patients' allocation.
RESULTS


Eighty-two patients with median sternotomy after CABG surgery were randomly allocated in a 1:1 ratio (SC: n = 42, OT: n = 42). Slow vital capacity and pain intensity were measured at baseline and at 12 weeks and 52 weeks after surgery. Pain intensity was significantly lower in the OT group 12 weeks after surgery (3.6-0.80 vs. 2.6 to 1.2, p = 0.030). One year after surgery, there still was a significantly lower pain intensity in the OT group (3.6-0.56, vs. 2.6 to 1.2, p = 0.014). No significant changes between groups were found in pulmonary function. There were no adverse events reported.
CONCLUSIONS


From this study, it can be concluded that the addition of OT to exercise-based cardiac rehabilitation may lead to significantly greater reductions in thoracic pain after CABG surgery.
TRIAL REGISTRATION


This study was registered on ClinicalTrials.gov (NCT01714791).",2020,"One year after surgery, there still was a significantly lower pain intensity in the OT group (3.6-0.56, vs. 2.6 to 1.2, p = 0.014).",['Eighty-two patients with median sternotomy after CABG surgery'],"['standard cardiac rehabilitation programme', 'OT', 'coronary artery bypass graft (CABG) surgery', 'osteopathic treatments (OTs']","['chronic thoracic pain', 'Pulmonary function', 'pain intensity', 'Slow vital capacity and pain intensity', 'Pain intensity', 'thoracic pain', 'pulmonary function']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1282959', 'cui_str': 'Median sternotomy'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0419203', 'cui_str': 'Osteopathy'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231957', 'cui_str': 'Slow vital capacity'}]",82.0,0.255498,"One year after surgery, there still was a significantly lower pain intensity in the OT group (3.6-0.56, vs. 2.6 to 1.2, p = 0.014).","[{'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Roncada', 'Affiliation': 'Jessa Hospital, Heart Centre Hasselt, Hasselt, Belgium; Commission for Osteopathic Research, Practice and Promotion, Mechelen, Belgium. Electronic address: gert.roncada@telenet.be.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.03.004']
2783,32819979,Prognostic value of 12 novel cardiological biomarkers in stable coronary artery disease. A 10-year follow-up of the placebo group of the Copenhagen CLARICOR trial.,"OBJECTIVE


To assess if 12 novel circulating biomarkers, when added to 'standard predictors' available in general practice, could improve the 10-year prediction of cardiovascular events and mortality in patients with stable coronary heart disease.
DESIGN


The patients participated as placebo receiving patients in the randomised clarithromycin for patients with stable coronary artery disease (CLARICOR) trial at a random time in their disease trajectory.
SETTING


Five Copenhagen University cardiology departments and a coordinating centre.
PARTICIPANTS


1998 participants with stable coronary artery disease.
OUTCOMES


Death and composite of myocardial infarction, unstable angina pectoris, cerebrovascular disease and death.
RESULTS


When only 'standard predictors' were included, 83.4% of all-cause death predictions and 68.4% of composite outcome predictions were correct. Log(calprotectin) and log(cathepsin-S) were not associated (p≥0.01) with the outcomes, not even as single predictors. Adding the remaining 10 biomarkers (high-sensitive assay cardiac troponin T; neutrophil gelatinase-associated lipocalin; osteoprotegerin; N-terminal pro-B-type natriuretic peptide; tumour necrosis factor receptor 1 and 2; pregnancy-associated plasma protein A; endostatin; YKL40; cathepsin-B), which were all individually significantly associated with the prediction of the two outcomes, increased the figures to 84.7% and 69.7%.
CONCLUSION


When 'standard predictors' routinely available in general practices are used for risk assessment in consecutively sampled patients with stable coronary artery disease, the addition of 10 novel biomarkers to the prediction model improved the correct prediction of all-cause death and the composite outcome by <1.5%.
TRIAL REGISTRATION NUMBER


NCT00121550.",2020,"Log(calprotectin) and log(cathepsin-S) were not associated (p≥0.01) with the outcomes, not even as single predictors.","['Five Copenhagen University cardiology departments and a coordinating centre', '1998 participants with stable coronary artery disease', 'patients with stable coronary heart disease', 'consecutively sampled patients with stable coronary artery disease', 'patients with stable coronary artery disease (CLARICOR) trial at a random time in their disease trajectory', 'stable coronary artery disease']","['log(cathepsin-S', 'clarithromycin', 'placebo']","['Death and composite of myocardial infarction, unstable angina pectoris, cerebrovascular disease and death']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0587453', 'cui_str': 'Cardiology department'}, {'cui': 'C0427184', 'cui_str': 'No incoordination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}]",1998.0,0.0905681,"Log(calprotectin) and log(cathepsin-S) were not associated (p≥0.01) with the outcomes, not even as single predictors.","[{'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Winkel', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark pwinkel@ctu.dk.'}, {'ForeName': 'Janus Christian', 'Initials': 'JC', 'LastName': 'Jakobsen', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Hilden', 'Affiliation': 'Section of Biostatistics, Department of Public Health Research, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gorm Boje', 'Initials': 'GB', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Hvidovre Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Kjøller', 'Affiliation': 'Cardiology, Herlev and Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Sajadieh', 'Affiliation': 'Department of Cardiology, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Kastrup', 'Affiliation': 'Rigshopitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hans Jørn', 'Initials': 'HJ', 'LastName': 'Kolmos', 'Affiliation': 'Department of Clinical Microbiology, Odense University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kasper Karmark', 'Initials': 'KK', 'LastName': 'Iversen', 'Affiliation': 'Department of Cardiology, Herlev Hospital, Copenhagen University Hospital, Herlev, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Bjerre', 'Affiliation': 'The Medical Research Laboratory, Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Ärnlöv', 'Affiliation': 'Family Medicine and Primary Care, Karolinska Universitetssjukhuset, Stockholm, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Gluud', 'Affiliation': 'The Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}]",BMJ open,['10.1136/bmjopen-2019-033720']
2784,32819981,mHealth app using machine learning to increase physical activity in diabetes and depression: clinical trial protocol for the DIAMANTE Study.,"INTRODUCTION


Depression and diabetes are highly disabling diseases with a high prevalence and high rate of comorbidity, particularly in low-income ethnic minority patients. Though comorbidity increases the risk of adverse outcomes and mortality, most clinical interventions target these diseases separately. Increasing physical activity might be effective to simultaneously lower depressive symptoms and improve glycaemic control. Self-management apps are a cost-effective, scalable and easy access treatment to increase physical activity. However, cutting-edge technological applications often do not reach vulnerable populations and are not tailored to an individual's behaviour and characteristics. Tailoring of interventions using machine learning methods likely increases the effectiveness of the intervention.
METHODS AND ANALYSIS


In a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm. The uniform random intervention group receives the same messages, but chosen from the messaging banks with equal probabilities. The control group receives a weekly mood message. We aim to recruit 276 adults from primary care clinics aged 18-75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5). We will compare passively collected daily step counts, self-report PHQ-8 and most recent haemoglobin A1c from medical records at baseline and at intervention completion at 6-month follow-up.
ETHICS AND DISSEMINATION


The Institutional Review Board at the University of California San Francisco approved this study (IRB: 17-22608). We plan to submit manuscripts describing our user-designed methods and testing of the adaptive learning algorithm and will submit the results of the trial for publication in peer-reviewed journals and presentations at (inter)-national scientific meetings.
TRIAL REGISTRATION NUMBER


NCT03490253; pre-results.",2020,"In a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression.","['low-income ethnic minority patients with comorbid diabetes and depression', 'diabetes and depression', '276 adults from primary care clinics aged 18-75 years who have been diagnosed with current diabetes and show elevated depressive symptoms (Patient Health Questionnaire depression scale-8 (PHQ-8) >5']","['adaptive intervention group receives messages chosen from different messaging banks by a reinforcement learning algorithm', 'machine learning', 'text-messaging smartphone application']",['physical activity'],"[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439084', 'cui_str': '>5'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442598', 'cui_str': 'Bank'}, {'cui': 'C0035007', 'cui_str': 'Psychological Reinforcement'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0707012,"In a three-arm randomised controlled trial, we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression.","[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Aguilera', 'Affiliation': 'School of Social Welfare, University of California Berkeley, Berkeley, California, USA.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Figueroa', 'Affiliation': 'School of Social Welfare, University of California Berkeley, Berkeley, California, USA c.a.figueroa@berkeley.edu.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Hernandez-Ramos', 'Affiliation': 'School of Social Welfare, University of California Berkeley, Berkeley, California, USA.'}, {'ForeName': 'Urmimala', 'Initials': 'U', 'LastName': 'Sarkar', 'Affiliation': 'UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA.'}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Cemballi', 'Affiliation': 'UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gomez-Pathak', 'Affiliation': 'School of Social Welfare, University of California Berkeley, Berkeley, California, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Miramontes', 'Affiliation': 'UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA.'}, {'ForeName': 'Elad', 'Initials': 'E', 'LastName': 'Yom-Tov', 'Affiliation': 'Microsoft Research, Herzeliya, Israel.'}, {'ForeName': 'Bibhas', 'Initials': 'B', 'LastName': 'Chakraborty', 'Affiliation': 'Centre for Quantitative Medicine, Duke-National University of Singapore Medical School, Singapore.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Centre for Quantitative Medicine, Duke-National University of Singapore Medical School, Singapore.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Centre for Quantitative Medicine, Duke-National University of Singapore Medical School, Singapore.'}, {'ForeName': 'Arghavan', 'Initials': 'A', 'LastName': 'Modiri', 'Affiliation': 'Computer Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jai', 'Initials': 'J', 'LastName': 'Aggarwal', 'Affiliation': 'Computer Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Jay Williams', 'Affiliation': 'Computer Science, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Courtney R', 'Initials': 'CR', 'LastName': 'Lyles', 'Affiliation': 'UCSF Center for Vulnerable Populations in the Division of General Internal Medicine San Francisco, Zuckerberg San Francisco General Hospital, San Francisco, California, USA.'}]",BMJ open,['10.1136/bmjopen-2019-034723']
2785,32819997,The VRIMM study: Virtual Reality for IMMunisation pain in young children-protocol for a randomised controlled trial.,"INTRODUCTION


Pain caused by routine immunisations is distressing to children, their parents and those administering injections. If poorly managed, it can lead to anxiety about future medical procedures, needle phobia and avoidance of future vaccinations and other medical treatment. Several strategies, such as distraction, are used to manage the distress associated with routine immunisations. Virtual reality (VR), a technology which transports users into an immersive 'virtual world', has been used to manage pain and distress in various settings such as burns dressing changes and dental treatments. In this study, we aim to compare the effectiveness of VR to standard care in a general practice setting as a distraction technique to reduce pain and distress in 4-year-old children receiving routine immunisations.
METHODS AND ANALYSIS


The study is a randomised controlled clinical trial comparing VR with standard care in 100 children receiving routine 4-year-old vaccination. Children attending a single general practice in metropolitan Melbourne, Australia will be allocated using blocked randomisation to either VR or standard care. Children in the intervention group will receive VR intervention prior to vaccination in addition to standard care; the control group will receive standard care. The primary outcome is the difference in the child's self-rated pain scores between the VR intervention and control groups measured using The Faces Pain Scale-Revised. Secondary outcomes include another measure of self-rated pain (the Poker Chip Tool), parent/guardian and healthcare provider ratings of pain (standard 100 mm visual analogue scales) and adverse effects.
ETHICS AND DISSEMINATION


Ethics approval has been obtained in Australia from the Royal Australian College of General Practitioners National Research and Evaluation Ethics Committee (NREEC 18-010). Recruitment commenced in July 2019. We plan to submit study findings for publication in a peer-reviewed journal and presentation at relevant conferences.
TRIAL REGISTRATION NUMBER


ACTRN12618001363279.",2020,The primary outcome is the difference in the child's self-rated pain scores between the VR intervention and control groups measured using The Faces Pain Scale-Revised.,"['100 children receiving routine 4-year-old vaccination', 'young children-protocol', 'Children attending a single general practice in metropolitan Melbourne, Australia', '4-year-old children receiving routine immunisations']","['VR intervention prior to vaccination in addition to standard care; the control group will receive standard care', 'Virtual reality (VR']","[""child's self-rated pain scores"", 'another measure of self-rated pain (the Poker Chip Tool), parent/guardian and healthcare provider ratings of pain (standard 100\u2009mm visual analogue scales) and adverse effects', 'pain and distress', 'Faces Pain Scale-Revised']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0337547', 'cui_str': 'Younger child'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0857208', 'cui_str': 'Routine vaccination'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0057856', 'cui_str': 'iproplatin'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0023226', 'cui_str': 'Legal guardian'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",,0.108349,The primary outcome is the difference in the child's self-rated pain scores between the VR intervention and control groups measured using The Faces Pain Scale-Revised.,"[{'ForeName': 'Kirrily', 'Initials': 'K', 'LastName': 'Ellerton', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Harishan', 'Initials': 'H', 'LastName': 'Tharmarajah', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Rimma', 'Initials': 'R', 'LastName': 'Medres', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Lona', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ringelblum', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Kateena', 'Initials': 'K', 'LastName': 'Vogel', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Dolphin', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'McKellar', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Bridson', 'Affiliation': 'Wellness on Wellington General Practice, Rowville, Victoria, Australia.'}, {'ForeName': 'Marietta', 'Initials': 'M', 'LastName': 'John-White', 'Affiliation': 'Emergency Department, Monash Medical Centre Clayton, Clayton, Victoria, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Craig', 'Affiliation': 'Emergency Department, Monash Medical Centre Clayton, Clayton, Victoria, Australia Simon.Craig@monashhealth.org.'}]",BMJ open,['10.1136/bmjopen-2020-038354']
2786,32819999,"Impact of comprehensive molecular testing to reduce antibiotic use in community-acquired pneumonia (RADICAP): a randomised, controlled, phase IV clinical trial protocol.","INTRODUCTION


Community-acquired pneumonia (CAP) continues to be a major health problem worldwide and is one of the main reasons for prescribing antibiotics. However, the causative agent is often not identified, resulting in antibiotic overtreatment, which is a key driver of antimicrobial resistance and adverse events. We aim to test the hypothesis that comprehensive molecular testing, compared with routine microbiological testing, would be effective in reducing antibiotic use in patients with CAP.
METHODS AND ANALYSIS


We will perform a randomised, controlled, open-label clinical trial with two parallel groups (1:1) at two tertiary hospitals between 2020 and 2022. Non-severely immunosuppressed adults hospitalised for CAP will be considered eligible. Patients will be randomly assigned to receive either the experimental diagnosis (comprehensive molecular testing plus routine microbiological testing) or standard diagnosis (only microbiological routine testing). The primary endpoint will be antibiotic consumption measured as days of antibiotic therapy per 1000 patient-days. Secondary endpoints will be de-escalation to narrower antibiotic treatment, time to switch from intravenous to oral antibiotics, days to reaching an aetiological diagnosis, antibiotic-related side effects, length of stay, days to clinical stability, intensive care unit admission, days of mechanical ventilation, hospital readmission up to 30 days after randomisation and death from any cause by 48 hours and 30 days after randomisation. We will need to include 440 subjects to be able to reject the null hypothesis that both groups have equal days of antibiotic therapy per 1000 patient-days with a probability >0.8.
ETHICS AND DISSEMINATION


Ethical approval has been obtained from the Ethics Committee of Bellvitge Hospital (AC028/19) and from the Spanish Medicines and Medical Devices Agency, and it is valid for all participating centres under existing Spanish legislation. Results will be presented at international meetings and will be made available to patients, their caregivers and funders.
TRIAL REGISTRATION NUMBER


ClinicalTrials: NCT04158492. EudraCT: 2018-004880-29.",2020,"We will need to include 440 subjects to be able to reject the null hypothesis that both groups have equal days of antibiotic therapy per 1000 patient-days with a probability >0.8.
","['community-acquired pneumonia (RADICAP', '440 subjects', 'patients with CAP', 'two parallel groups (1:1) at two tertiary hospitals between 2020 and 2022']","['comprehensive molecular testing', 'EudraCT', 'experimental diagnosis (comprehensive molecular testing plus routine microbiological testing) or standard diagnosis (only microbiological routine testing']","['de-escalation to narrower antibiotic treatment, time to switch from intravenous to oral antibiotics, days to reaching an aetiological diagnosis, antibiotic-related side effects, length of stay, days to clinical stability, intensive care unit admission, days of mechanical ventilation, hospital readmission up to 30 days after randomisation and death', 'antibiotic consumption']","[{'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C4517777', 'cui_str': '440'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0025953', 'cui_str': 'microbiology'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.28202,"We will need to include 440 subjects to be able to reject the null hypothesis that both groups have equal days of antibiotic therapy per 1000 patient-days with a probability >0.8.
","[{'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Abelenda-Alonso', 'Affiliation': ""Infectious Diseases, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain gabi.abelenda.alonso@gmail.com.""}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rombauts', 'Affiliation': ""Infectious Diseases, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Gudiol', 'Affiliation': ""Infectious Diseases, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Meije', 'Affiliation': 'Infectious Diseases Unit-Department of Internal Medicine, Hospital de Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Clemente', 'Affiliation': 'Infectious Diseases Unit-Department of Internal Medicine, Hospital de Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Lucía', 'Initials': 'L', 'LastName': 'Ortega', 'Affiliation': 'Infectious Diseases Unit-Department of Internal Medicine, Hospital de Barcelona, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ardanuy', 'Affiliation': ""Department of Clinical Microbiology Unit, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Niubó', 'Affiliation': ""Department of Clinical Microbiology Unit, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Padullés', 'Affiliation': ""Department of Farmacology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Videla', 'Affiliation': ""Department of Clinical Farmacology, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Tebe', 'Affiliation': ""Statistics Advisory Service, Institut d\\'Investigacio Biomedica de Bellvitge, L'Hospitalet de Llobregat, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Carratalà', 'Affiliation': ""Infectious Diseases, Bellvitge University Hospital, L'Hospitalet de Llobregat, Barcelona, Spain.""}]",BMJ open,['10.1136/bmjopen-2020-038957']
2787,32820000,"Study protocol for a double-blind, randomised placebo-controlled trial evaluating clinical effects of platelet-rich plasma injection for acute grade-2 hamstring tear among high performance athletes.","INTRODUCTION


Hamstring injury among athletes often results in significant morbidity. Currently, there are controversies regarding the clinical use of platelet-rich plasma (PRP) for the treatment of acute hamstring injury.
METHODS AND ANALYSIS


This study is a single-centre double-blind randomised placebo-controlled trial. Sixty-eight patients will be randomised to receive under ultrasound guidance either a single injection of leucocyte-rich PRP (LR-PRP) or normal saline. All patients will undergo a standardised hamstring rehabilitation programme under the supervision of a sports physiotherapist. Outcome data will be collected before intervention (baseline), and thereafter on a weekly basis. The primary outcome measure is the duration to return-to-play. It is defined as the duration (in days) from the date on which the injury occurred until the patients were pain-free, able to perform the active knee extension test and have regained hamstring muscle strength. Secondary outcome measures include assessment of pain intensity and the effect of pain on to day-to-day functions using the self-reported Brief Pain Inventory-Short Form questionnaire. Both the primary and secondary outcomes were assessed at baseline and thereafter once a week until return to play. Also, hamstring injury recurrence within the first 6 months after recovery will be monitored via telephone. The results of this study will provide insights into the effect of LR-PRP in muscle and may help to identify the best PRP application protocol for muscle injuries.
ETHICS AND DISSEMINATION


Ethics approval were obtained from the Medical Research Ethics Committee of the University of Malaya Medical Centre. Results of this trial will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER


ISRCTN76844299.",2020,"Currently, there are controversies regarding the clinical use of platelet-rich plasma (PRP) for the treatment of acute hamstring injury.
","['All patients will undergo a standardised hamstring rehabilitation programme under the supervision of a sports physiotherapist', 'acute grade-2 hamstring tear among high performance athletes', 'Sixty-eight patients']","['ultrasound guidance either a single injection of leucocyte-rich PRP (LR-PRP) or normal saline', 'platelet-rich plasma injection', 'placebo']","['hamstring injury recurrence', 'duration to return-to-play', 'assessment of pain intensity and the effect of pain on to day-to-day functions using the self-reported Brief Pain Inventory-Short Form questionnaire']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0450387', 'cui_str': '68'}]","[{'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0023516', 'cui_str': 'Leukocyte'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4042817', 'cui_str': 'Return to Play'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",68.0,0.577388,"Currently, there are controversies regarding the clinical use of platelet-rich plasma (PRP) for the treatment of acute hamstring injury.
","[{'ForeName': 'Mohamad Shariff', 'Initials': 'MS', 'LastName': 'A Hamid', 'Affiliation': 'Sports Medicine, Universiti Malaya, Kuala Lumpur, Wilayah Persekutuan, Malaysia ayip@um.edu.my.'}, {'ForeName': 'Kamarul Hashimy', 'Initials': 'KH', 'LastName': 'Hussein', 'Affiliation': 'Division of Sports Medicine, National Sports Institute of Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Ahmad Munawwar', 'Initials': 'AM', 'LastName': 'Helmi Salim', 'Affiliation': 'Division of Sports Medicine, National Sports Institute of Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Arshad', 'Initials': 'A', 'LastName': 'Puji', 'Affiliation': 'Department of Orthopaedic and Traumatology, Hospital Kuala Lumpur, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Rosnah', 'Initials': 'R', 'LastName': 'Mat Yatim', 'Affiliation': 'Division of Sports Medicine, National Sports Institute of Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Chin Chee', 'Initials': 'CC', 'LastName': 'Yong', 'Affiliation': 'Division of Sports Medicine, National Sports Institute of Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}, {'ForeName': 'Thomas Wong Yong', 'Initials': 'TWY', 'LastName': 'Sheng', 'Affiliation': 'Division of Sports Medicine, National Sports Institute of Malaysia, Kuala Lumpur, Wilayah Persekutuan, Malaysia.'}]",BMJ open,['10.1136/bmjopen-2020-039105']
2788,32820137,Acute Effects of Single- Versus Double-Leg Postactivation Potentiation on Postural Balance of Older Women: An Age-Matched Controlled Study.,"AIMS


To compare the postactivation potentiation effects of isometric contraction until failure in double- and single-leg tasks on older women's balance.
METHODS


The one-legged balance test was performed before and immediately after a rise-to-toes task until the task failure. Older women were divided into two groups: a group performed the task with double leg (n = 43) and the other group with single-leg support (n = 55).
RESULTS


The single-leg group showed slower velocity of sway post rise-to-toes task (pre = 4.02 ± 1; post = 3.78 ± 1.15 m/s; p = .04) without differences for the center of pressure path length (pre = 79 ± 21; post = 75 ± 23 cm; p = .08). In the double-leg group, faster velocity of sway (pre = 4 ± 1.22; post = 4.25 ± 1.13; p = .03) and increased center of pressure path length (pre = 80 ± 24; post = 85 ± 23 cm; p = .03) were observed after the task.
CONCLUSIONS


The single-leg group showed improved balance outcomes due to postactivation potentiation, while the double-leg group showed worsened balance consistent with muscle fatigue.",2020,"(pre = 4 ± 1.22; post = 4.25 ± 1.13; p = .03) and increased center of pressure path length (pre = 80 ± 24; post = 85 ± 23 cm; p = .03) were observed after the task.
","[""older women's balance"", 'Older Women', 'Older women']","['Single', 'double- and single-leg tasks', 'Double-Leg Postactivation Potentiation']","['center of pressure path length', 'balance outcomes', 'faster velocity of sway', 'Postural Balance', 'worsened balance consistent with muscle fatigue', 'slower velocity of sway post rise-to-toes task']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0086188', 'cui_str': 'Drug Potentiation'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C1256755', 'cui_str': 'Postural balance'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0040357', 'cui_str': 'Toe structure'}]",,0.120621,"(pre = 4 ± 1.22; post = 4.25 ± 1.13; p = .03) and increased center of pressure path length (pre = 80 ± 24; post = 85 ± 23 cm; p = .03) were observed after the task.
","[{'ForeName': 'Ilha G', 'Initials': 'IG', 'LastName': 'Fernandes', 'Affiliation': ''}, {'ForeName': 'Matheus A', 'Initials': 'MA', 'LastName': 'Souza', 'Affiliation': ''}, {'ForeName': 'Matheus L', 'Initials': 'ML', 'LastName': 'Oliveira', 'Affiliation': ''}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Miarka', 'Affiliation': ''}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Barbosa', 'Affiliation': ''}, {'ForeName': 'Andreia C', 'Initials': 'AC', 'LastName': 'Queiroz', 'Affiliation': ''}, {'ForeName': 'Alexandre C', 'Initials': 'AC', 'LastName': 'Barbosa', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0314']
2789,32820139,Blood Flow Restriction Training for the Rotator Cuff: A Randomized Controlled Trial.,"CONTEXT


Blood flow restriction (BFR) training utilizes a tourniquet, applied to the proximal portion of one or more extremities, to occlude blood flow during exercise. Significant gains in strength and cross-sectional area can be achieved in muscles, both distal and proximal to BFR cuff application.
PURPOSE


To compare strength gains of the rotator cuff and changes in tendon size in subjects who performed side-lying external-rotation exercise with or without BFR.
METHODS


Forty-six subjects (mean age 25.0 [2.2] y) were randomized to either a BFR + exercise group or to the exercise-only group. Subjects performed 4 sets of the exercise (30/15/15/15 repetitions) at 30% 1-repetition maximum 2 days per week for 8 weeks.
RESULTS


Subjects in both groups experienced strength gains in the supraspinatus and the external rotators (P = .000, P = .000). However, there was no difference in strength gains between groups for the supraspinatus (P = .750) or the external rotators (P = .708). Subjects in both groups experienced increases in supraspinatus tendon thickness (BFR P = .041, exercise only P = .011). However, there was no difference between groups (P = .610).
CONCLUSIONS


Exercise with BFR applied to the proximal upper extremity did not augment rotator cuff strength gains or tendon thickness when compared with subjects who only exercised. This study did demonstrate that performing multiple sets of high repetitions at a low load led to significant increases in rotator cuff strength and tendon size in the dominant upper extremity.",2020,"Subjects in both groups experienced increases in supraspinatus tendon thickness (BFR P = .041, exercise only P = .011).","['Forty-six subjects (mean age 25.0 [2.2]\xa0y', 'subjects who performed side-lying external-rotation exercise with or without BFR', 'Rotator Cuff']","['Blood Flow Restriction Training', 'BFR + exercise group or to the exercise-only group']","['rotator cuff strength and tendon size', 'strength gains', 'Blood flow restriction', 'rotator cuff strength gains or tendon thickness', 'strength gains of the rotator cuff and changes in tendon size', 'supraspinatus tendon thickness']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",46.0,0.0130821,"Subjects in both groups experienced increases in supraspinatus tendon thickness (BFR P = .041, exercise only P = .011).","[{'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Brumitt', 'Affiliation': ''}, {'ForeName': 'Marcey Keefer', 'Initials': 'MK', 'LastName': 'Hutchison', 'Affiliation': ''}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Kang', 'Affiliation': ''}, {'ForeName': 'Zach', 'Initials': 'Z', 'LastName': 'Klemmer', 'Affiliation': ''}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Stroud', 'Affiliation': ''}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Neil Patrick', 'Initials': 'NP', 'LastName': 'Cayanan', 'Affiliation': ''}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Shishido', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0815']
2790,32820320,Effect of alirocumab on major adverse cardiovascular events according to renal function in patients with a recent acute coronary syndrome: prespecified analysis from the ODYSSEY OUTCOMES randomized clinical trial.,"AIMS


Statins reduce cardiovascular risk in patients with acute coronary syndrome (ACS) and normal-to-moderately impaired renal function. It is not known whether proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors provide similar benefit across a range of renal function. We determined whether effects of the PCSK9 inhibitor alirocumab to reduce cardiovascular events and death after ACS are influenced by renal function.
METHODS AND RESULTS


ODYSSEY OUTCOMES compared alirocumab with placebo in patients with recent ACS and dyslipidaemia despite intensive statin treatment. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 was exclusionary. In 18 918 patients, baseline eGFR was 82.8 ± 17.6 mL/min/1.73 m2, and low-density lipoprotein cholesterol (LDL-C) was 92 ± 31 mg/dL. At 36 months, alirocumab decreased LDL-C by 48.5% vs. placebo but did not affect eGFR (P = 0.65). Overall, alirocumab reduced risk of the primary outcome (coronary heart disease death, non-fatal myocardial infarction, ischaemic stroke, or unstable angina requiring hospitalization) with fewer deaths. There was no interaction between continuous eGFR and treatment on the primary outcome or death (P = 0.14 and 0.59, respectively). Alirocumab reduced primary outcomes in patients with eGFR ≥90 mL/min/1.73 m2 (n = 7470; hazard ratio 0.784, 95% confidence interval 0.670-0.919; P = 0.003) and 60 to <90 (n = 9326; 0.833, 0.731-0.949; P = 0.006), but not in those with eGFR < 60 (n = 2122; 0.974, 0.805-1.178; P = 0.784). Adverse events other than local injection-site reactions were similar in both groups across all categories of eGFR.
CONCLUSIONS


In patients with recent ACS, alirocumab was associated with fewer cardiovascular events and deaths across the range of renal function studied, with larger relative risk reductions in those with eGFR > 60 mL/min/1.73 m2.",2020,"In patients with recent ACS, alirocumab was associated with fewer cardiovascular events and deaths across the range of renal function studied, with larger relative risk reductions in those with eGFR > 60 mL/min/1.73 m2.","['patients with recent ACS and dyslipidaemia despite intensive statin treatment', 'In 18 918 patients, baseline eGFR was 82.8\u2009±\u200917.6\u2009mL', 'patients with eGFR ≥90', 'patients with a recent acute coronary syndrome', 'patients with acute coronary syndrome (ACS) and normal-to-moderately impaired renal function']","['alirocumab', 'Alirocumab', 'alirocumab with placebo', 'PCSK9 inhibitor alirocumab', 'placebo']","['cardiovascular risk', 'death', 'cardiovascular events and deaths', 'Estimated glomerular filtration rate (eGFR', 'LDL-C', 'low-density lipoprotein cholesterol (LDL-C', 'Overall, alirocumab reduced risk of the primary outcome (coronary heart disease death, non-fatal myocardial infarction, ischaemic stroke, or unstable angina requiring hospitalization) with fewer deaths']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1100660', 'cui_str': 'Proprotein Convertase'}, {'cui': 'C0038601', 'cui_str': 'Subtilisins'}, {'cui': 'C0165249', 'cui_str': 'Kexin'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205388', 'cui_str': 'Few'}]",18918.0,0.519613,"In patients with recent ACS, alirocumab was associated with fewer cardiovascular events and deaths across the range of renal function studied, with larger relative risk reductions in those with eGFR > 60 mL/min/1.73 m2.","[{'ForeName': 'José', 'Initials': 'J', 'LastName': 'Tuñón', 'Affiliation': 'Division of Cardiology, Fundación Jiménez Díaz, Autónoma University, and CIBER CV, Avenida Reyes Católicos 2, 28040 Madrid, Spain.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Department of Cardiology, Université de Paris, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Université de Paris, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Paris, France.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Díaz', 'Affiliation': 'Cardiology Department, Estudios Clínicos Latinoamérica, Instituto Cardiovascular de Rosario, Rosario, Argentina; Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Yong-Un', 'Initials': 'YU', 'LastName': 'Kim', 'Affiliation': 'R & D clinical Development, Sanofi, Paris, France.'}, {'ForeName': 'Qian H', 'Initials': 'QH', 'LastName': 'Li', 'Affiliation': 'Clinical Sciences-Cardiovascular & Metabolism Therapeutics, Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mueller', 'Affiliation': 'Cardiovascular Research Institute Basel (CRIB) and Department of Cardiology, University Hospital Basel, University of Basel, Switzerland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Parkhomenko', 'Affiliation': 'Institute of Cardiology, Kyiv, Ukraine.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Clinical Sciences-Cardiovascular & Metabolism Therapeutics, Regeneron Pharmaceuticals, Tarrytown, NY, USA.'}, {'ForeName': 'Piyamitr', 'Initials': 'P', 'LastName': 'Sritara', 'Affiliation': 'Department of Medicine, Ramathibodi Hospital, Bangkok, Thailand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn, NY, USA.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehaa498']
2791,32820324,Oesophageal Probe Evaluation in Radiofrequency Ablation of Atrial Fibrillation (OPERA): results from a prospective randomized trial.,"AIMS


The aim of the study was to determine the incidence of oesophageal lesions after radiofrequency ablation (RFA) of atrial fibrillation (AF) with or without the use of oesophageal temperature probes.
METHODS AND RESULTS


Two hundred patients were prospectively randomized into two groups: the OPERA+ group underwent RFA using oesophageal probes (SensiTherm™); the OPERA- group received RFA using fixed energy levels of 25 W at the posterior wall without an oesophageal probe. All patients underwent post-interventional endoscopy and Holter-electrocardiogram after 6 months. (Clinical.Trials.gov: NCT03246594). One hundred patients were randomized in OPERA+ and 100 patients in OPERA-. The drop-out rate was 10%. In total, 18/180 (10%) patients developed endoscopically diagnosed oesophageal lesions (EDEL). There was no difference between the groups with 10/90 (11%) EDEL in OPERA+ vs. 8/90 (9%) in OPERA- (P = 0.62). Despite the higher power delivered at the posterior wall in OPERA+ [28 ± 4 vs. 25 ± 2 W (P = 0.001)], the average EDEL size was equal [5.7 ± 2.6 vs. 4.5 ± 1.7 mm (P = 0.38)]. The peak temperature did not correlate with EDEL size. During follow-up, no patient died. Only one patient in OPERA- required a specific therapy for treatment of the lesion. Cumulative AF recurrence after 6 (3-13) months was 28/87 (32%) vs. 34/88 (39%), P = 0.541.
CONCLUSION


This first randomized study demonstrates that intraoesophageal temperature monitoring using the SensiTherm™ probe does not affect the probability of developing EDEL. The peak temperature measured by the thermoprobe seems not to correlate with the incidence of EDEL. Empiric energy reduction at the posterior wall did not affect the efficacy of the procedure.",2020,"Cumulative AF recurrence after 6 (3-13) months was 28/87 (32%) vs. 34/88 (39%), P = 0.541.
","['One hundred patients were randomized in OPERA+ and 100 patients in OPERA', 'Two hundred patients']","['radiofrequency ablation (RFA) of atrial fibrillation (AF', 'Radiofrequency Ablation of Atrial Fibrillation (OPERA', 'OPERA+ group underwent RFA using oesophageal probes (SensiTherm™); the OPERA- group received RFA using fixed energy levels of 25\u2009W at the posterior wall without an oesophageal probe']","['endoscopically diagnosed oesophageal lesions (EDEL', 'average EDEL size', 'probability of developing EDEL', 'Cumulative AF recurrence', 'peak temperature', 'incidence of oesophageal lesions']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0227701', 'cui_str': 'Structure of posterior wall of urinary bladder'}]","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",200.0,0.044547,"Cumulative AF recurrence after 6 (3-13) months was 28/87 (32%) vs. 34/88 (39%), P = 0.541.
","[{'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Schoene', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Arya', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Grashoff', 'Affiliation': 'Leipzig Heart Institute GmbH, Leipzig, Germany.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Knopp', 'Affiliation': 'Helios Klinikum Leisnig, Leisnig, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Weber', 'Affiliation': 'KMG Klinikum Güstrow, Güstrow, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Lerche', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'König', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Hilbert', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kircher', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Livio', 'Initials': 'L', 'LastName': 'Bertagnolli', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Borislav', 'Initials': 'B', 'LastName': 'Dinov', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Hindricks', 'Affiliation': 'Department of Electrophysiology, Heart Center, University of Leipzig, Struempellstrasse 39, 04289 Leipzig, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Halm', 'Affiliation': 'Parkkrankenhaus Leipzig, Leipzig, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Zachäus', 'Affiliation': 'Parkkrankenhaus Leipzig, Leipzig, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Sommer', 'Affiliation': 'Herz- und Diabetes Zentrum NRW, Ruhr University Bochum, Bad Oeynhausen, Germany.'}]","Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology",['10.1093/europace/euaa209']
2792,32820548,An Adaptive Physiologically Based Pharmacokinetic-Driven Design to Investigate the Effect of Itraconazole and Rifampicin on the Pharmacokinetics of Molibresib (GSK525762) in Healthy Female Volunteers.,"Molibresib (GSK525762), an orally bioavailable small molecule with 2 major equipotent active metabolites, is being developed for the treatment of cancers. Molibresib is a substrate of cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp). To enable administering safe doses of molibresib to healthy volunteers, this 2-part randomized, open-label, crossover drug-drug interaction trial was conducted as an adaptive design study using physiologically based pharmacokinetic (PBPK) modeling and simulation to predict the lowest doses of molibresib that could be safely administered alone (10 mg) or with itraconazole and rifampicin (strong inhibitors and inducers of CYP3A and P-gp, respectively). PBPK simulation guided the molibresib dose (5 mg) to be administered along with itraconazole in part 1. Itraconazole increased total exposure (AUC) of molibresib by 4.15-fold with a 66% increase in C max  , whereas the total AUC and C max  for the 2 major active metabolites of molibresib decreased by about 70% and 87%, respectively. A second PBPK simulation was conducted with part 1 data to also include the active metabolites to update the recommendation for the molibresib dose (20 mg) with rifampicin. With rifampicin, the AUC and C max  of molibresib decreased by approximately 91% and 80%, respectively, whereas the AUC of the 2 active metabolites decreased to a lesser extent (8%), with a 2-fold increase in C max  . The results of this study confirmed the in vitro data that molibresib is a substrate for CYP3A4. The adaptive design, including Simcyp simulations, allowed evaluation of 2 drug interactions of an oncology drug in a single trial, thus minimizing time and exposures administered to healthy subjects.",2020,"Itraconazole increased total exposure (AUC) of molibresib by 4.15-fold with a 66% increase in C max  , whereas the total AUC and C max  for the 2 major active metabolites of molibresib decreased by about 70% and 87%, respectively.","['Healthy Female Volunteers', 'healthy volunteers', 'healthy subjects']","['itraconazole', 'cytochrome P450 (CYP', 'Itraconazole', 'rifampicin', 'Molibresib (GSK525762', 'Itraconazole and Rifampicin', 'itraconazole and rifampicin (strong inhibitors and inducers of CYP3A']","['total exposure (AUC) of molibresib', 'AUC and C max  of molibresib', 'total AUC and C max  for the 2 major active metabolites of molibresib']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0008381', 'cui_str': 'Cholesterol monooxygenase (side-chain cleaving)'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C4682384', 'cui_str': 'molibresib'}, {'cui': 'C4317349', 'cui_str': 'GSK525762'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0059563', 'cui_str': 'Cytochrome p450 CYP3A enzyme'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C4682384', 'cui_str': 'molibresib'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0308848,"Itraconazole increased total exposure (AUC) of molibresib by 4.15-fold with a 66% increase in C max  , whereas the total AUC and C max  for the 2 major active metabolites of molibresib decreased by about 70% and 87%, respectively.","[{'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Riddell', 'Affiliation': 'GlaxoSmithKline Research and Development, Ermington, NSW, Australia.'}, {'ForeName': 'Aarti', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'Drug Metabolism and Pharmacokinetics, GlaxoSmithKline R&D, Ware, UK.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Collins', 'Affiliation': 'Drug Metabolism and Pharmacokinetics, GlaxoSmithKline R&D, Ware, UK.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Biometrics, GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Schramek', 'Affiliation': 'Clinical Programming, GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Brandon E', 'Initials': 'BE', 'LastName': 'Kremer', 'Affiliation': 'Research and Development Oncology, GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Ferron-Brady', 'Affiliation': 'Clinical Pharmacology Modeling and Simulation, GlaxoSmithKline, Collegeville, Pennsylvania, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1711']
2793,32820551,Comparing life review writing with active control groups: Results of a feasibility study.,"INTRODUCTION


Life review writing can be used to improve depressive symptoms in well older adults, but it is unclear whether the reminiscing, writing, or socialising is associated with the improvements. This study assessed the feasibility of a controlled trial comparing life review writing with two active control groups designed to isolate the acts of (a) engaging in a meaningful leisure activity and (b) socialising.
METHODS


Twenty-four participants from a 100-bed assisted living facility were enrolled in the study. Participants ranged in age from 70 to 98 years (M = 83.9, SD = 7.6). Eight 1-hour weekly sessions were held, with participants assigned to one of three groups: (a) life review writing, (b) painting, or (c) coffee from around the world. At baseline, participants completed a demographic and health questionnaire, the Mini-Cog, and the Geriatric Depression Scale Short Form (GDS-15). The GDS-15 was administered again at weeks 4 and 8, along with the health questionnaire at post-test.
RESULTS


Nearly 25% (N = 24) of the facility's residents attended at least one session, with an average attendance rate of 66.4%, or 5.3 sessions. However, to achieve this participation rate, our original plan to employ random assignment had to be abandoned. The groups were a partial success insofar as we successfully isolated engaging in a meaningful activity in the painting group, but the writing group engaged in less reminiscing than hoped. At post-test, seven participants reported health, mood, and social life benefits. GDS-15 scores fluctuated over time, with no significant improvement from pre- to post-test.
CONCLUSION


The residents' low willingness to be randomised creates a serious selection bias, but randomising volunteers into different activities runs counter to client-centred therapy. To scrutinise the mechanisms of change of life review writing, we recommend comparing two writing groups: one that reminisces and one that does not.",2020,"scores fluctuated over time, with no significant improvement from pre- to post-test.
","['Participants ranged in age from 70 to 98\xa0years (M\xa0', 'Twenty-four participants from a 100-bed assisted living facility were enrolled in the study']","['life review writing, (b) painting, or (c) coffee from around the world', 'GDS-15']","['average attendance rate', 'health, mood, and social life benefits', 'demographic and health questionnaire, the Mini-Cog, and the Geriatric Depression Scale Short Form (GDS-15', 'depressive symptoms']","[{'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}]","[{'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3496553', 'cui_str': 'Mini-Cog'}, {'cui': 'C2919619', 'cui_str': 'Geriatric depression scale short form'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",24.0,0.0554179,"scores fluctuated over time, with no significant improvement from pre- to post-test.
","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schelly', 'Affiliation': 'Occupational Therapy Department, Clarkson University, Potsdam, NY, USA.'}, {'ForeName': 'Alisha', 'Initials': 'A', 'LastName': 'Ohl', 'Affiliation': 'Occupational Therapy Department, Clarkson University, Potsdam, NY, USA.'}, {'ForeName': 'Yessica', 'Initials': 'Y', 'LastName': 'Moronta', 'Affiliation': 'Occupational Therapy Department, Clarkson University, Potsdam, NY, USA.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Nadres', 'Affiliation': 'Occupational Therapy Department, Clarkson University, Potsdam, NY, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Snyder', 'Affiliation': 'Occupational Therapy Department, Clarkson University, Potsdam, NY, USA.'}]",Australian occupational therapy journal,['10.1111/1440-1630.12691']
2794,32820619,"Phase 1 Studies to Define the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles of the Nonsteroidal Mineralocorticoid Receptor Antagonist Apararenone in Healthy Volunteers.","Apararenone is a long-acting, nonsteroidal mineralocorticoid receptor antagonist (MRA). The safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single- and multiple-dose apararenone were assessed in 3 phase 1 randomized, double-blind studies in 223 healthy adults. Study 1 assessed the PK, safety/tolerability, and PD of single-dose apararenone (3.75-640 mg) and multiple-dose apararenone (10-40 mg/day on days 1-14, 320 mg loading dose on day 1 + 10 mg/day on days 2-14, or 40-320 mg loading dose on day 1 + 2.5-20 mg/day on days 2-14) in Caucasian and Black men and women. Study 2 assessed the PK and safety of single-dose apararenone (5-320 mg) in healthy Japanese men. Study 3 assessed the PK, PD, and safety/tolerability of single-dose apararenone (160 or 640 mg) or eplerenone (200 mg; only for 160 mg of apararenone), each after fludrocortisone challenge in Caucasian men. In studies 1 and 2, an approximately dose-proportional increase was observed in PK parameters over the apararenone dose range of 3.75-40 mg; at higher doses, a less than dose-proportional increase was observed. Food, sex, age, and race had no apparent effect on apararenone PK. A long half-life was seen for apararenone and its principal metabolite; in addition, the exposure of the metabolite was lower than that of apararenone. Apararenone suppressed the decrease in urinary sodium and potassium ion ratio that occurs after loading with fludrocortisone. These studies support the mechanism of action of apararenone as an MRA, and further clinical development is warranted.",2020,Apararenone suppressed the decrease in urinary sodium and potassium ion ratio that occurs after loading with fludrocortisone.,"['Caucasian men', '223 healthy adults', 'Caucasian and Black men and women', 'healthy Japanese men', 'Healthy Volunteers']","['eplerenone (200 mg; only for 160 mg of apararenone', 'Apararenone', 'Nonsteroidal Mineralocorticoid Receptor Antagonist Apararenone', 'apararenone']","['safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single- and multiple-dose apararenone', 'PK, PD, and safety/tolerability', 'urinary sodium and potassium ion ratio', 'Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Profiles', 'PK parameters', 'PK, safety/tolerability, and PD']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0961485', 'cui_str': 'eplerenone'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0597277', 'cui_str': 'Potassium Ion'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",223.0,0.0528627,Apararenone suppressed the decrease in urinary sodium and potassium ion ratio that occurs after loading with fludrocortisone.,"[{'ForeName': 'Tadakatsu', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Atsuhiro', 'Initials': 'A', 'LastName': 'Kawaguchi', 'Affiliation': 'Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.855']
2795,32820982,The impact of intradialytic cycling on the removal of protein-bound uraemic toxins: A randomised cross-over study.,"The evidence on impact of intradialytic exercise on the removal of urea, is conflictive. Impact of exercise on kinetics of serum levels of protein-bound uraemic toxins, known to exert toxicity and to have kinetics dissimilar of those of urea, has so far not been explored. Furthermore, if any effect, the most optimal intensity, time point and/or required duration of intradialytic exercise to maximise removal remain obscure. We therefore studied the impact of different intradialytic cycling schedules on the removal of protein-bound uraemic toxins during haemodialysis (HD).This randomised cross-over study included seven stable patients who were dialysed with an FX800 dialyser during three consecutive midweek HD sessions of 240 min: (A) without cycling; (B) cycling for 60 min between 60th and 120th minutes of dialysis; and (C) cycling for 60 min between 150th and 210th minutes, with the same cycling load as in session B. Blood and dialysate flows were respectively 300 and 500 mL/min. Blood was sampled from the blood inlet at different time points, and dialysate was partially collected (300 mL/h). Small water soluble solutes and protein-bound toxins were quantified and intradialytic reduction ratios (RR) and overall removal were calculated per solute.Total solute removal and reduction ratios were not different between the three test sessions, except for the reduction ratios RR 60-120  and RR 150-210  for potassium.In conclusion, we add evidence to the existing literature that, regardless of the timing within the dialysis session, intradialytic exercise has no impact on small solute clearance, and demonstrated also a lack of impact for protein-bound solutes.",2020,"Total solute removal and reduction ratios were not different between the three test sessions, except for the reduction ratios RR 60-120  and RR 150-210  for potassium.",['seven stable patients who were dialysed with an FX800 dialyser during three consecutive midweek HD sessions of 240\u2009min: (A'],"['intradialytic exercise', 'without cycling; (B) cycling for 60\u2009min between 60th and 120th minutes of dialysis', 'intradialytic cycling']","['Total solute removal and reduction ratios', 'intradialytic reduction ratios (RR) and overall removal']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439232', 'cui_str': 'min'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",7.0,0.0511764,"Total solute removal and reduction ratios were not different between the three test sessions, except for the reduction ratios RR 60-120  and RR 150-210  for potassium.","[{'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'De Vos', 'Affiliation': 'University Hospital Ghent, Gent, Belgium.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Lemarcq', 'Affiliation': 'University Hospital Ghent, Gent, Belgium.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'Dhondt', 'Affiliation': 'University Hospital Ghent, Gent, Belgium.'}, {'ForeName': 'Griet', 'Initials': 'G', 'LastName': 'Glorieux', 'Affiliation': 'University Hospital Ghent, Gent, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Van Biesen', 'Affiliation': 'University Hospital Ghent, Gent, Belgium.'}, {'ForeName': 'Sunny', 'Initials': 'S', 'LastName': 'Eloot', 'Affiliation': 'University Hospital Ghent, Gent, Belgium.'}]",The International journal of artificial organs,['10.1177/0391398820949880']
2796,32821038,Negative-pressure wound therapy compared with standard dressings following surgical treatment of major trauma to the lower limb: the WHiST RCT.,"BACKGROUND


Major trauma is the leading cause of death in people aged < 45 years. Patients with major trauma usually have lower-limb fractures. Surgery to fix the fractures is complicated and the risk of infection may be as high as 27%. The type of dressing applied after surgery could potentially reduce the risk of infection.
OBJECTIVES


To assess the deep surgical site infection rate, disability, quality of life, patient assessment of the surgical scar and resource use in patients with surgical incisions associated with fractures following major trauma to the lower limbs treated with incisional negative-pressure wound therapy versus standard dressings.
DESIGN


A pragmatic, multicentre, randomised controlled trial.
SETTING


Twenty-four specialist trauma hospitals representing the UK Major Trauma Network.
PARTICIPANTS


A total of 1548 adult patients were randomised from September 2016 to April 2018. Exclusion criteria included presentation > 72 hours after injury and inability to complete questionnaires.
INTERVENTIONS


Incisional negative-pressure wound therapy ( n  = 785), in which a non-adherent absorbent dressing covered with a semipermeable membrane is connected to a pump to create a partial vacuum over the wound, versus standard dressings not involving negative pressure ( n  = 763). Trial participants and the treating surgeon could not be blinded to treatment allocation.
MAIN OUTCOME MEASURES


Deep surgical site infection at 30 days was the primary outcome measure. Secondary outcomes were deep infection at 90 days, the results of the Disability Rating Index, health-related quality of life, the results of the Patient and Observer Scar Assessment Scale and resource use collected at 3 and 6 months post surgery.
RESULTS


A total of 98% of participants provided primary outcome data. There was no evidence of a difference in the rate of deep surgical site infection at 30 days. The infection rate was 6.7% (50/749) in the standard dressing group and 5.8% (45/770) in the incisional negative-pressure wound therapy group (intention-to-treat odds ratio 0.87; 95% confidence interval 0.57 to 1.33;  p  = 0.52). There was no difference in the deep surgical site infection rate at 90 days: 13.2% in the standard dressing group and 11.4% in the incisional negative-pressure wound therapy group (odds ratio 0.84, 95% confidence interval 0.59 to 1.19;  p  = 0.32). There was no difference between the two groups in disability, quality of life or scar appearance at 3 or 6 months. Incisional negative-pressure wound therapy did not reduce the cost of treatment and was associated with a low probability of cost-effectiveness.
LIMITATIONS


Owing to the emergency nature of the surgery, we anticipated that some patients who were randomised would subsequently be unable or unwilling to participate. However, the majority of the patients (85%) agreed to participate. Therefore, participants were representative of the population with lower-limb fractures associated with major trauma.
CONCLUSIONS


The findings of this study do not support the use of negative-pressure wound therapy in patients having surgery for major trauma to the lower limbs.
FUTURE WORK


Our work suggests that the use of incisional negative-pressure wound therapy dressings in other at-risk surgical wounds requires further investigation. Future research may also investigate different approaches to reduce postoperative infections, for example the use of topical antibiotic preparations in surgical wounds and the role of orthopaedic implants with antimicrobial coatings when fixing the associated fracture.
TRIAL REGISTRATION


Current Controlled Trials ISRCTN12702354 and UK Clinical Research Network Portfolio ID20416.
FUNDING


This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in  Health Technology Assessment ; Vol. 24, No. 38. See the NIHR Journals Library for further project information.",2020,"There was no difference in the deep surgical site infection rate at 90 days: 13.2% in the standard dressing group and 11.4% in the incisional negative-pressure wound therapy group (odds ratio 0.84, 95% confidence interval 0.59 to 1.19;  p  = 0.32).","['participants were representative of the population with lower-limb fractures associated with major trauma', 'patients having surgery for major trauma to the lower limbs', 'Twenty-four specialist trauma hospitals representing the UK Major Trauma Network', 'people aged <\u200945 years', 'A total of 1548 adult patients were randomised from September 2016 to April 2018', 'patients with surgical incisions associated with fractures following major trauma to the lower limbs treated with', 'Patients with major trauma usually have lower-limb fractures']","['negative-pressure wound therapy', 'incisional negative-pressure wound therapy dressings', 'Negative-pressure wound therapy', 'incisional negative-pressure wound therapy versus standard dressings', 'Incisional negative-pressure wound therapy']","['deep infection at 90 days, the results of the Disability Rating Index, health-related quality of life, the results of the Patient and Observer Scar Assessment Scale and resource use collected at 3 and 6 months post surgery', 'deep surgical site infection rate', 'infection rate', 'disability, quality of life or scar appearance', 'rate of deep surgical site infection', 'risk of infection', 'deep surgical site infection rate, disability, quality of life, patient assessment of the surgical scar and resource use']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1542178', 'cui_str': 'Fracture of lower leg'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332677', 'cui_str': 'Major injury'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0334150', 'cui_str': 'Surgical scar'}]",1548.0,0.129949,"There was no difference in the deep surgical site infection rate at 90 days: 13.2% in the standard dressing group and 11.4% in the incisional negative-pressure wound therapy group (odds ratio 0.84, 95% confidence interval 0.59 to 1.19;  p  = 0.32).","[{'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Costa', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Juul', 'Initials': 'J', 'LastName': 'Achten', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Knight', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'May Ee', 'Initials': 'ME', 'LastName': 'Png', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Dutton', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Madan', 'Affiliation': 'Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Karan', 'Initials': 'K', 'LastName': 'Vadher', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Melina', 'Initials': 'M', 'LastName': 'Dritsaki', 'Affiliation': 'Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Masters', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Spoors', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Campolier', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Parsons', 'Affiliation': 'Statistics and Epidemiology Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Fernandez', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Patient and public involvement group member.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Grant', 'Affiliation': 'Patient and public involvement group member.'}, {'ForeName': 'Jagdeep', 'Initials': 'J', 'LastName': 'Nanchahal', 'Affiliation': 'Oxford Trauma, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24380']
2797,32821078,Epigastric pain syndrome: What can traditional Chinese medicine do? A randomized controlled trial of Biling Weitong Granules.,"BACKGROUND


Recent research suggests that although prokinetic agents, acid suppressors, and radical treatment for  Helicobacter pylori  infection may be effective in patients with functional dyspepsia (FD), a large proportion of patients still fail to respond to these treatments or may suffer from severe adverse reactions. Many traditional Chinese medicinal herbs can regulate the status of the entire body and have special advantages in the treatment of functional diseases. The present study was designed to verify the efficacy of Biling Weitong Granules (BLWTG), a traditional Chinese medicinal herbal compound formula, in alleviating epigastric pain syndrome (EPS) in FD patients, in an attempt to provide an effective prescription for the clinical treatment of this disease.
AIM


To evaluate the clinical efficacy and safety of BLWTG in treating EPS in patients with FD.
METHODS


In this multicenter, stratified, randomized, double-blind, placebo-controlled, parallel group clinical trial, eligible patients were randomized into the BLWTG and placebo groups who were treated for 6 wk. Efficacy indicators including the severity and frequency of EPS and the time to pain resolution and safety indicators including adverse events were observed and compared.
RESULTS


The baseline demographic data and clinical characteristics, such as epigastric pain symptoms, pain intensity, and frequency of attacks, were matched between the two groups before randomization. After 6 wk of treatment and after the center effect was eliminated, the epigastric pain was significantly improved in 28.33% and 85.59% of the patients in the placebo and BLWTG groups, respectively ( P  < 0.05). At 6 wk, the resolution rate of epigastric pain was 15% and 69.49% in the placebo and BLWTG groups, respectively ( P  < 0.05). The differences of total FD clinical score between these two groups were significant ( P  < 0.05) at 2, 4, and 6 wk ( P  < 0.05). The scores of each item and the total score in the Functional Digestive Disorders Quality of Life Questionnaire showed significant differences between the two groups at 6 wk after both the center and interaction effects were eliminated ( P  < 0.05). There was no significant difference in the incidence of adverse events between the two groups, and no serious adverse event was noted during the observation.
CONCLUSION


Compared with placebo, BLWTG markedly improved EPS in FD patients without causing serious adverse reactions.",2020,"There was no significant difference in the incidence of adverse events between the two groups, and no serious adverse event was noted during the observation.
","['patients with functional dyspepsia (FD', 'epigastric pain syndrome (EPS) in FD patients', 'Epigastric pain syndrome', 'patients with FD.\nMETHODS']","['Biling Weitong Granules (BLWTG', 'BLWTG', 'placebo']","['total score in the Functional Digestive Disorders Quality of Life Questionnaire', 'clinical efficacy and safety', 'epigastric pain', 'EPS', 'resolution rate of epigastric pain', 'total FD clinical score', 'epigastric pain symptoms, pain intensity, and frequency of attacks', 'severity and frequency of EPS and the time to pain resolution and safety indicators including adverse events', 'incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0267167', 'cui_str': 'Nonulcer dyspepsia'}, {'cui': 'C0232493', 'cui_str': 'Epigastric pain'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0012242', 'cui_str': 'Disorder of digestive system'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0232493', 'cui_str': 'Epigastric pain'}, {'cui': 'C0059954', 'cui_str': 'Exophthalmos producing substance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.153839,"There was no significant difference in the incidence of adverse events between the two groups, and no serious adverse event was noted during the observation.
","[{'ForeName': 'Yan-Dong', 'Initials': 'YD', 'LastName': 'Wen', 'Affiliation': 'Department of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Institution of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Ying-Pan', 'Initials': 'YP', 'LastName': 'Zhao', 'Affiliation': 'Department of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Hebei Provincial Hospital of Chinese Medicine, Shijiazhuang 050011, Hebei Province, China.'}, {'ForeName': 'Jun-Xiang', 'Initials': 'JX', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.'}, {'ForeName': 'Hui-Zhen', 'Initials': 'HZ', 'LastName': 'Li', 'Affiliation': 'Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300250, China.'}, {'ForeName': 'Li-Li', 'Initials': 'LL', 'LastName': 'Chi', 'Affiliation': 'Department of Gastroenterology, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250014, Shandong Province, China.'}, {'ForeName': 'Zheng-Hua', 'Initials': 'ZH', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China.'}, {'ForeName': 'Yan-Ping', 'Initials': 'YP', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, Tianjin Nankai Hospital, Tianjin 300100, China.'}, {'ForeName': 'Jin-Kang', 'Initials': 'JK', 'LastName': 'Xu', 'Affiliation': 'Department of Gastroenterology, The Kunshan Hospital Affiliated to Nanjing University of Chinese Medicine, Kunshan 215300, Jiangsu Province, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Institution of Clinical Pharmacology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Xu-Dong', 'Initials': 'XD', 'LastName': 'Tang', 'Affiliation': 'Department of Gastroenterology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing 100091, China. txdly@sina.com.'}]",World journal of gastroenterology,['10.3748/wjg.v26.i28.4170']
2798,32821082,"Simple Methods for Evaluating 4 Types of Biomarkers: Surrogate Endpoint, Prognostic, Predictive, and Cancer Screening.","We review simple methods for evaluating 4 types of biomarkers. First, we discuss the evaluation of surrogate endpoint biomarkers (to shorten a randomized trial) using 2 statistical and 3 biological criteria. Second, we discuss the evaluation of prognostic biomarkers (to predict the risk of disease) by comparing data collection costs with the anticipated net benefit of risk prediction. Third, we discuss the evaluation of predictive markers (to search for a promising subgroup in a randomized trial) using a multivariate subpopulation treatment effect pattern plot involving a risk difference or responders-only benefit function. Fourth, we discuss the evaluation of cancer screening biomarkers (to predict cancer in asymptomatic persons) using methodology to substantially reduce the sample size with stored specimens.",2020,"Fourth, we discuss the evaluation of cancer screening biomarkers (to predict cancer in asymptomatic persons) using methodology to substantially reduce the sample size with stored specimens.",[],[],[],[],[],[],,0.064939,"Fourth, we discuss the evaluation of cancer screening biomarkers (to predict cancer in asymptomatic persons) using methodology to substantially reduce the sample size with stored specimens.","[{'ForeName': 'Stuart G', 'Initials': 'SG', 'LastName': 'Baker', 'Affiliation': 'Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Barnett S', 'Initials': 'BS', 'LastName': 'Kramer', 'Affiliation': 'Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.'}]",Biomarker insights,['10.1177/1177271920946715']
2799,32826049,Differences in perceived stress during ovarian stimulation between women with infertility and those pursing oocyte cryopreservation.,"OBJECTIVE


To determine whether the purpose of ovarian stimulation (oocyte cryopreservation [OC] versus in vitro fertilization (IVF) is associated with perceived stress before or after ovarian stimulation; and whether perceived stress is associated with ovarian stimulation outcomes.
DESIGN


Prospective cohort study.
SETTING


Academic practice.
PATIENTS


Women undergoing their first ovarian stimulation cycle as part of a randomized clinical trial, the Learning from Online Video Education (LOVE) study (NCT02979990).
INTERVENTIONS


Questionnaire before and after ovarian stimulation.
MAIN OUTCOME MEASURES(S)


Perceived stress scale (PSS) scores before and after stimulation. The number of oocytes collected was a secondary measure.
RESULTS


After adjustment for age, income, race, education, financial assistance, and fertility diagnosis, the indication for treatment (IVF vs. OC) was a significant predictor of pretreatment PSS scores. IVF participants had higher pretreatment scores (18.01 ± 6.43) than did OC participants (15.62 ± 5.61). Posttreatment PSS scores did not differ between the two groups. IVF participants experienced a decrease of 0.85 ± 2.34 points in PSS scores after treatment, whereas OC participant scores were stable over time. The trajectory of PSS scores differed between the two groups and neared significance. Financial support was a significant predictor of pretreatment and posttreatment PSS scores for the entire cohort. Neither pretreatment nor posttreatment PSS was predictive of the number oocytes collected.
CONCLUSION


Compared with OC patients, IVF patients have higher stress levels, which decrease after ovarian stimulation. Perceived stress does not affect oocyte yield.",2020,Posttreatment PSS scores did not differ between the two groups.,"['Women undergoing their first ovarian stimulation cycle as part of a randomized clinical trial, the Learning from Online Video Education (LOVE) study (NCT02979990', 'women with infertility and those pursing oocyte cryopreservation', 'Academic practice']","['vitro fertilization (IVF', 'ovarian stimulation (oocyte cryopreservation [OC']","['trajectory of PSS scores', 'Perceived stress scale (PSS) scores', 'PSS scores', 'stress levels', 'Posttreatment PSS scores', 'OC participant scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0010405', 'cui_str': 'Cryopreservation'}]","[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0010405', 'cui_str': 'Cryopreservation'}]","[{'cui': 'C4304048', 'cui_str': 'PSS (Perceived Stress Scale) score'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]",,0.14667,Posttreatment PSS scores did not differ between the two groups.,"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Adeleye', 'Affiliation': 'Section of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, The University of Chicago, Chicago, Illinois. Electronic address: Aadeleye@bsd.uchicago.edu.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Cruz', 'Affiliation': 'Center for Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Pasch', 'Affiliation': 'Center for Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Huddleston', 'Affiliation': 'Center for Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, San Francisco, California.'}]",Fertility and sterility,['10.1016/j.fertnstert.2020.05.025']
2800,32826102,The role of peer support education model on the quality of life and self-care behaviors of patients with myocardial infarction.,"OBJECTIVE


This study aimed to assess the effect of peer education on the quality of life and self-care behaviors of patients with myocardial infarction.
METHODS


In this clinical trial, 70 patients with myocardial infarction meeting the inclusion criteria were assigned to experimental (n = 35) or control (n = 35) groups using block randomization. Patients in the intervention group received two one-hour training sessions on the third day after myocardial infarction during the CCU stay along with routine care. Education intervention was performed by peers. The control group will follow routine care. All patients selected were assessed using McNews' quality of life questionnaire and Miller self-care questionnaire, respectively before the intervention and also one month after discharge. Chi-square and t-test were used to analyze the data.
RESULTS


After the intervention, the mean of quality of life and the mean score of self-care behaviors in the experimental group were significantly higher compared to the control group.
CONCLUSIONS


According to the results, to improve the quality of life and promote the self-care behaviors in such patients, using peer education along with healthcare professionals is recommended.
PRACTICE IMPLICATION


This patient education approach had a significant impact on quality of life and self-care behavior.",2020,"After the intervention, the mean of quality of life and the mean score of self-care behaviors in the experimental group were significantly higher compared to the control group.
","['patients with myocardial infarction', '70 patients with myocardial infarction meeting the inclusion criteria']","['peer support education model', 'peer education']","['quality of life and self-care behaviors', 'mean of quality of life and the mean score of self-care behaviors', 'quality of life and self-care behavior', ""McNews' quality of life questionnaire and Miller self-care questionnaire"", 'quality of life and promote the self-care behaviors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0402830', 'cui_str': 'Miller'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}]",70.0,0.0316886,"After the intervention, the mean of quality of life and the mean score of self-care behaviors in the experimental group were significantly higher compared to the control group.
","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Ebrahimi', 'Affiliation': 'Randomized Controlled Trial Research Center, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abbasi', 'Affiliation': 'Department of Nursing, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Bagheri', 'Affiliation': 'Department of Nursing, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Basirinezhad', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Shakeri', 'Affiliation': 'Department of Nursing, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mohammadpourhodki', 'Affiliation': 'Department of Nursing, Kashmar Center of Higher Health Education, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: mohammadpourhr@mums.ac.ir.'}]",Patient education and counseling,['10.1016/j.pec.2020.08.002']
2801,32826122,Evidence-Based Medicine Improves the Emergent Management of Peritonsillar Abscesses Using Point-of-Care Ultrasound.,"BACKGROUND


Physical examination for peritonsillar abscess (PTA) has limited sensitivity. Traditional management involves blind needle aspiration, which has a false negative rate of 10-24%. A randomized controlled trial by Costantino et al. demonstrated that point-of-care ultrasound (POCUS) improves PTA management.
OBJECTIVES


Compare the use and impact of POCUS between patient cohorts prior to and after the trial by Costantino et al.
METHODS


Retrospective cohort study of adult patients diagnosed with PTA. Cohort 1 presented to the emergency department (ED) January 2007-December 2008. Cohort 2 presented between January 2013 and December 2014. Data were separated into those with POCUS vs. without ultrasound (NUS). Primary endpoint was POCUS utilization. Secondary endpoints were successful aspiration, otolaryngology (ear, nose, and throat [ENT]) consultation, computed tomography (CT) imaging, unscheduled return visits, and length of stay (LOS). The Fisher's exact and t-tests analyzed data.
RESULTS


Cohort 1 enrolled 48 patients, vs. 114 patients for cohort 2. Twelve patients in cohort 1 had a POCUS (25%) vs 89 in cohort 2 (78%) (p < 0.0001; odds ratio [OR] 0.09 (95% confidence interval [CI] 0.04-0.20). Emergency physician (EP) successful aspiration: 89.1% POCUS vs. 24.5% NUS (p < 0.0001; OR 25 [95% CI 10-59]). Combined EP/ENT successful aspiration: 99.0% POCUS vs. 80.3% NUS (p < 0.0001; OR 24 [95% CI 3-193]). ENT consultation:12.9% POCUS vs. 65.6% NUS (p < 0.0001; OR 0.07 [95% CI 0.03-0.17]). CT usage: 23.8% POCUS vs. 37.7% NUS (p = 0.07; OR 0.51 [95% CI 0.25-1.02]). Return visits: 3.96% POCUS vs. 18.0% NUS (p = 0.004; OR 0.18 [95% CI 0.05-0.61]).
CONCLUSION


POCUS use has increased for PTA treatment, improves aspiration, and decreases consultations, CTs, return visits, and LOS.",2020,"Return visits: 3.96% POCUS vs. 18.0% NUS (p = 0.004; OR 0.18 [95% CI 0.05-0.61]).
","['Cohort 1 presented to the emergency department (ED) January 2007-December 2008', 'peritonsillar abscess (PTA', 'Cohort 2 presented between January 2013 and December 2014', 'Cohort 1 enrolled 48 patients, vs. 114 patients for cohort 2', 'adult patients diagnosed with PTA']","['POCUS vs. without ultrasound (NUS', 'care ultrasound (POCUS']","['consultations, CTs, return visits, and LOS', 'successful aspiration, otolaryngology (ear, nose, and throat [ENT]) consultation, computed tomography (CT) imaging, unscheduled return visits, and length of stay (LOS', 'POCUS utilization']","[{'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0031157', 'cui_str': 'Peritonsillar abscess'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0029892', 'cui_str': 'Otolaryngology'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0031354', 'cui_str': 'Pharyngeal structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.221001,"Return visits: 3.96% POCUS vs. 18.0% NUS (p = 0.004; OR 0.18 [95% CI 0.05-0.61]).
","[{'ForeName': 'Ryan C', 'Initials': 'RC', 'LastName': 'Gibbons', 'Affiliation': 'Department of Emergency Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Costantino', 'Affiliation': 'Department of Emergency Medicine, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2020.06.030']
2802,32826167,Intralesional allogeneic adipose-derived stem cells application in chronic diabetic foot ulcer: Phase I/2 safety study.,"BACKGROUND


Impaired wound healing is a major cause of morbidity in diabetic patients by causing chronic ulcers. This study aimed to investigate the safety and outcomes after intralesional allogeneic adipose-derived mesenchymal stem cells injection in chronic diabetic foot ulcers.
METHODS


Twenty patients (12 male and eight female) were involved in the study. We randomized the patients into two groups of 10 patients each. The study group was treated with allogeneic adipose-derived mesenchymal stem cells injection with standard diabetic wound care. The control group received only standard diabetic wound care. Patient demographics, wound characteristics, wound closure time, amputation rates and clinical scores were evaluated.
RESULTS


The mean age was 57.3 ± 6.6 years. The mean follow-up duration was 48.0 (range, 26-50) months. Wound closure was achieved in 17 of 20 lesions (study group, 9 lesions; control group, 8 lesions; respectively). The mean time to wound closure was 31.0 ± 10.7 (range, 22-55) days in the study group, 54.8 + 15.0 (range, 30-78) days in the control group (p = 0.002). In three patients, minor amputations were performed (one patient in study group; two patients in the control group, p = 0.531). There was a significant difference between groups in terms of postoperative Short Form 36- physical functioning (p = 0.017) and Short Form 36-general health (p = 0.010).
CONCLUSION


Allogeneic adipose-derived mesenchymal stem cells injection was found to be a safe and effective method with a positive contribution to wound-healing time in the treatment of chronic diabetic foot ulcers.",2020,"There was a significant difference between groups in terms of postoperative Short Form 36- physical functioning (p = 0.017) and Short Form 36-general health (p = 0.010).
","['Twenty patients (12 male and eight female', 'chronic diabetic foot ulcer', 'chronic diabetic foot ulcers', 'patients into two groups of 10 patients each', 'diabetic patients by causing chronic ulcers', 'The mean age was 57.3\u2009±\u20096.6 years']","['intralesional allogeneic adipose-derived mesenchymal stem cells injection', 'Intralesional allogeneic adipose-derived stem cells application', 'standard diabetic wound care', 'allogeneic adipose-derived mesenchymal stem cells injection with standard diabetic wound care', 'Allogeneic adipose-derived mesenchymal stem cells injection']","['Wound closure', 'Patient demographics, wound characteristics, wound closure time, amputation rates and clinical scores', 'postoperative Short Form 36- physical functioning', 'mean time to wound closure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0333297', 'cui_str': 'Chronic ulcer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C4704950', 'cui_str': 'Mesenchymal Stem Cells, Adipose-Derived'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4728046', 'cui_str': 'Diabetic wound'}]","[{'cui': 'C0450015', 'cui_str': 'Method of wound closure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0305358,"There was a significant difference between groups in terms of postoperative Short Form 36- physical functioning (p = 0.017) and Short Form 36-general health (p = 0.010).
","[{'ForeName': 'Erdal', 'Initials': 'E', 'LastName': 'Uzun', 'Affiliation': 'Department of Orthopedics and Traumatology, Faculty of Medicine, Erciyes University, Kayseri, Turkey. Electronic address: erdaluzun@erciyes.edu.tr.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Güney', 'Affiliation': 'Department of Orthopedics and Traumatology, Faculty of Medicine, Erciyes University, Kayseri, Turkey. Electronic address: aguney@erciyes.edu.tr.'}, {'ForeName': 'Zeynep Burçin', 'Initials': 'ZB', 'LastName': 'Gönen', 'Affiliation': 'Oral and Maxillofacial Surgery, Genome and Stem Cell Center, Erciyes University, Kayseri, Turkey. Electronic address: zburcin@gmail.com.'}, {'ForeName': 'Yusuf', 'Initials': 'Y', 'LastName': 'Özkul', 'Affiliation': 'Department of Medical Genetics, Faculty of Medicine, Erciyes University, Kayseri, Turkey. Electronic address: ozkul@erciyes.edu.t.'}, {'ForeName': 'İbrahim Halil', 'Initials': 'İH', 'LastName': 'Kafadar', 'Affiliation': 'Department of Orthopedics and Traumatology, Faculty of Medicine, Erciyes University, Kayseri, Turkey. Electronic address: ihkafadar@gmail.com.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Günay', 'Affiliation': 'Department of Orthopedics and Traumatology, Kanuni Training and Research Hospital, Trabzon, Turkey. Electronic address: drmahmut106@gmail.com.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Mutlu', 'Affiliation': 'Department of Orthopedics and Traumatology, Faculty of Medicine, Erciyes University, Kayseri, Turkey. Electronic address: profmahmutmutlu@gmail.com.'}]",Foot and ankle surgery : official journal of the European Society of Foot and Ankle Surgeons,['10.1016/j.fas.2020.08.002']
2803,30773968,A phase 2 clinical trial of eltrombopag for treatment of patients with myelodysplastic syndromes after hypomethylating-agent failure.,"Hypomethylating agents (HMA) are the standard of care for treatment of myelodysplastic syndromes (MDS). HMA-failure MDS has extremely poor prognosis. This study was designed to explore the utility of eltrombopag in post-HMA failure MDS patients. Patients were treated in one of two arms: eltrombopag as monotherapy (Arm A), or with continuation of HMA (Arm B). The starting eltrombopag dose was 200 mg orally daily. Twenty-nine patients with a median age of 72 years (42-84) were enrolled. The median number of prior treatment was 1 (1-5). Seven (24%) patients were enrolled in cohort A and 22 (76%) in cohort B. One early death (<30 days) occurred in cohort B due to infection/sepsis. Of 28 evaluable patients, 3 (11%) in cohort B experienced platelet improvement. Median overall survival was 12 months. This study demonstrated modest platelet improvement in some, without evidently increased toxicity or increased risk of leukemia progression.",2019,"Of 28 evaluable patients, 3 (11%) in cohort B experienced platelet improvement.","['post-HMA failure MDS patients', 'patients with myelodysplastic syndromes after hypomethylating-agent failure', 'Twenty-nine patients with a median age of 72 years (42-84) were enrolled']","['eltrombopag', 'eltrombopag as monotherapy', 'Hypomethylating agents (HMA']","['Median overall survival', 'toxicity', 'median number of prior treatment']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C2347761', 'cui_str': 'Childhood myelodysplastic syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1831905', 'cui_str': 'eltrombopag'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",29.0,0.0824612,"Of 28 evaluable patients, 3 (11%) in cohort B experienced platelet improvement.","[{'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Swaminathan', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center , Houston , TX , USA.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Borthakur', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center , Houston , TX , USA.'}, {'ForeName': 'Tapan M', 'Initials': 'TM', 'LastName': 'Kadia', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center , Houston , TX , USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ferrajoli', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center , Houston , TX , USA.'}, {'ForeName': 'Yesid', 'Initials': 'Y', 'LastName': 'Alvarado', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center , Houston , TX , USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Pemmaraju', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center , Houston , TX , USA.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'Bodden', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center , Houston , TX , USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Yearby', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center , Houston , TX , USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Konopleva', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center , Houston , TX , USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Khoury', 'Affiliation': 'Department of Hematopathology, University of Texas, MD Anderson Cancer Center , Houston , TX , USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bueso-Ramos', 'Affiliation': 'Department of Hematopathology, University of Texas, MD Anderson Cancer Center , Houston , TX , USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center , Houston , TX , USA.'}, {'ForeName': 'Courtney D', 'Initials': 'CD', 'LastName': 'DiNardo', 'Affiliation': 'Department of Leukemia, University of Texas, MD Anderson Cancer Center , Houston , TX , USA.'}]",Leukemia & lymphoma,['10.1080/10428194.2019.1576873']
2804,32820431,"Evaluation of the effect of probiotic lozenges in the treatment of recurrent aphthous stomatitis: a randomized, controlled clinical trial.","OBJECTIVES


The study aimed to explore the effectiveness of probiotics in the treatment of minor recurrent aphthous stomatitis (RAS).
MATERIALS AND METHODS


We performed a randomized, controlled clinical study. Sixty adult (group A) and 60 children patients (group B) with diagnosis of minor RAS were included. Both groups were divided into two subgroups; AI and BI (test subgroups) and AII and BII (control subgroups). For test subgroups, probiotic lozenges were consecutively administered twice daily, for 5 days. The size and pain level of ulcers were recorded on treatment days 0, 3, and 5. The outbreak frequency of RAS within 6 months was investigated for all subgroups.
RESULTS


Compared with baseline, an improvement was evident for all subgroups. However, for effectiveness in pain reduction, a statistically significant difference in favor of AI was observed for all evaluation periods when compared with control subgroup. Regarding effectiveness in ulcer size reduction, a statistically significant difference in favor of BI was observed at day 5 when compared with control subgroup. No significant difference was observed in the effectiveness index between subgroups AI and BI (test subgroups) except in effectiveness in pain reduction at day 3. The outbreak frequency decreased significantly in subgroup BI.
CONCLUSIONS


Topical application of probiotics decreased pain intensity and accelerates RAS healing. The effectiveness in pain reduction is more evident in adult patients while acceleration of healing is more evident in children.
CLINICAL RELEVANCE


Probiotics could be a well-tolerated, topical therapeutic agent in the treatment of minor RAS.
TRIAL REGISTRATION


ClinicalTrials.gov ID: NCT04383236.",2020,No significant difference was observed in the effectiveness index between subgroups AI and BI (test subgroups) except in effectiveness in pain reduction at day 3.,"['recurrent aphthous stomatitis', 'minor recurrent aphthous stomatitis (RAS', 'Sixty adult (group A) and 60 children patients (group B) with diagnosis of minor RAS were included']","['probiotic lozenges', 'probiotics']","['pain intensity and accelerates RAS healing', 'favor of BI', 'pain reduction', 'outbreak frequency', 'favor of AI', 'effectiveness index', 'size and pain level of ulcers']","[{'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C2931748', 'cui_str': 'Sutton disease 2'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0012652', 'cui_str': 'Disease outbreak'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]",60.0,0.074313,No significant difference was observed in the effectiveness index between subgroups AI and BI (test subgroups) except in effectiveness in pain reduction at day 3.,"[{'ForeName': 'Reham Lotfy', 'Initials': 'RL', 'LastName': 'Aggour', 'Affiliation': 'Department of Oral Medicine &Periodontology, Faculty of Dentistry, October 6 University, Cairo, Egypt. reham.dent@o6u.edu.eg.'}, {'ForeName': 'Sawsan Hafez', 'Initials': 'SH', 'LastName': 'Mahmoud', 'Affiliation': 'Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Abdelwhab', 'Affiliation': 'Department of Oral Medicine &Periodontology, Faculty of Dentistry, October 6 University, Cairo, Egypt.'}]",Clinical oral investigations,['10.1007/s00784-020-03527-7']
2805,32820473,Influence of the Chelating Solutions in the Resistance of Glass Fiber Posts to the Root Dentin.,"OBJECTIVE


To evaluate the influence of chelating agents (EDTA, citric acid and Tetraclean) on glass fiber posts adhesion to root dentin.
MATERIALS AND METHODS


Forty mandibular premolars single canals, with complete apical root, straight, circular cross sections were selected, accessed and had the cervical third prepared with Gates-Glidden drills, then included in resin, instrumented with ProTaper Universal and the root canal obturation was carried out. After, the samples were randomly divided into 4 groups (n = 10) to test the final irrigation solutions: G1:17% EDTA; G2:10% citric acid; G3: Tetraclean and G4: saline solution (control). After 30 days of storage (36.5° C and 100% humidity), the post preparation was performed leaving 4 mm of apical endodontic filling. Then, a fiber-glass post previously selected was coated with ED Primer adhesive system and resin sealer Panavia, installed and stored for 24 hours at 37°C. The samples were subjected to a tensile test with a constant speed of 1 mm/min with 2000 Kgf. The results were analyzed with the ANOVA test.
RESULTS


The statistical analyzes indicated no significant differences between the groups (p > 0.05).
CONCLUSION


The type of chelating agent used in the final irrigation of the endodontic treatment did not influence the tensile strength of the fixation system used to sealer the glass fiber posts to the intracanal dentin.",2020,The type of chelating agent used in the final irrigation of the endodontic treatment did not influence the tensile strength of the fixation system used to sealer the glass fiber posts to the intracanal dentin.,"['Forty mandibular premolars single canals, with complete apical root, straight, circular cross sections were selected, accessed and had the cervical third prepared with Gates-Glidden drills, then included in resin, instrumented with ProTaper Universal and the root canal obturation was carried out']","['chelating agents (EDTA, citric acid and Tetraclean', 'final irrigation solutions: G1:17% EDTA; G2:10% citric acid; G3: Tetraclean and G4: saline solution (control']",['tensile strength'],"[{'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C1282913', 'cui_str': 'Circular'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C4082130', 'cui_str': 'Prepared'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0035848', 'cui_str': 'Root canal obturation'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}]","[{'cui': 'C0007974', 'cui_str': 'Chelating agent'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C2974342', 'cui_str': 'Tetraclean'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1540845', 'cui_str': 'Tensile strength'}]",,0.0228196,The type of chelating agent used in the final irrigation of the endodontic treatment did not influence the tensile strength of the fixation system used to sealer the glass fiber posts to the intracanal dentin.,"[{'ForeName': 'Eduardo Fernandes', 'Initials': 'EF', 'LastName': 'Marques', 'Affiliation': 'Department of Endodontics, São Leopoldo Mandic Dental Research Center, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Marília Fagury Videira', 'Initials': 'MFV', 'LastName': 'Marceliano-Alves', 'Affiliation': 'Postgraduation Program, Iguaçu University, Nova Iguaçu, Brazil.'}, {'ForeName': 'Rina Andrea', 'Initials': 'RA', 'LastName': 'Pelegrine', 'Affiliation': 'Department of Endodontics, São Leopoldo Mandic Dental Research Center, Campinas, São Paulo, Brazil.'}, {'ForeName': 'Sérgio Luiz', 'Initials': 'SL', 'LastName': 'Pinheiro', 'Affiliation': 'Department of Dentistry, Pontifícia Universidade Católica de Campinas (PUC-Campinas), São Paulo, Brazil.'}, {'ForeName': 'Carlos Eduardo Da Silveira', 'Initials': 'CEDS', 'LastName': 'Bueno', 'Affiliation': 'Department of Endodontics, São Leopoldo Mandic Dental Research Center, Campinas, São Paulo, Brazil.'}]",European journal of dentistry,['10.1055/s-0040-1714761']
2806,32820475,Vasopressor Therapy in the Intensive Care Unit.,"After fluid administration for vasodilatory shock, vasopressors are commonly infused. Causes of vasodilatory shock include septic shock, post-cardiovascular surgery, post-acute myocardial infarction, postsurgery, other causes of an intense systemic inflammatory response, and drug -associated anaphylaxis. Therapeutic vasopressors are hormones that activate receptors-adrenergic: α1, α2, β1, β2; angiotensin II: AG1, AG2; vasopressin: AVPR1a, AVPR1B, AVPR2; dopamine: DA1, DA2. Vasopressor choice and dose vary widely because of patient and physician practice heterogeneity. Vasopressor adverse effects are excessive vasoconstriction causing organ ischemia/infarction, hyperglycemia, hyperlactatemia, tachycardia, and tachyarrhythmias. To date, no randomized controlled trial (RCT) of vasopressors has shown a decreased 28-day mortality rate. There is a need for evidence regarding alternative vasopressors as first-line vasopressors. We emphasize that vasopressors should be administered simultaneously with fluid replacement to prevent and decrease duration of hypotension in shock with vasodilation. Norepinephrine is the first-choice vasopressor in septic and vasodilatory shock. Interventions that decrease norepinephrine dose (vasopressin, angiotensin II) have not decreased 28-day mortality significantly. In patients not responsive to norepinephrine, vasopressin or epinephrine may be added. Angiotensin II may be useful for rapid resuscitation of profoundly hypotensive patients. Inotropic agent(s) (e.g., dobutamine) may be needed if vasopressors decrease ventricular contractility. Dopamine has fallen to almost no-use recommendation because of adverse effects; angiotensin II is available clinically; there are potent vasopressors with scant literature (e.g., methylene blue); and the novel V1a agonist selepressin missed on its pivotal RCT primary outcome. In pediatric septic shock, vasopressors, epinephrine, and norepinephrine are recommended equally because there is no clear evidence that supports the use of one vasoactive agent. Dopamine is recommended when epinephrine or norepinephrine is not available. New strategies include perhaps patients will be  started  on several vasopressors with complementary mechanisms of action, patients may be selected for particular vasopressors according to predictive biomarkers, and novel vasopressors may emerge with fewer adverse effects.",2020,"Interventions that decrease norepinephrine dose (vasopressin, angiotensin II) have not decreased 28-day mortality significantly.",[],"['Vasopressor Therapy', 'epinephrine or norepinephrine', 'Dopamine', 'Angiotensin', 'norepinephrine, vasopressin or epinephrine', 'norepinephrine dose (vasopressin, angiotensin II', 'Norepinephrine']","['28-day mortality rate', '28-day mortality', 'duration of hypotension']",[],"[{'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}]",,0.232552,"Interventions that decrease norepinephrine dose (vasopressin, angiotensin II) have not decreased 28-day mortality significantly.","[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Russell', 'Affiliation': ""Department of Medicine, Centre for Heart Lung Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Anthony C', 'Initials': 'AC', 'LastName': 'Gordon', 'Affiliation': 'Department of Surgery and Cancer, Division of Anaesthetics, Pain Medicine and Intensive Care, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Williams', 'Affiliation': 'Department of Medicine, Indiana University Health Methodist Hospital, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Boyd', 'Affiliation': ""Department of Medicine, Centre for Heart Lung Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Keith R', 'Initials': 'KR', 'LastName': 'Walley', 'Affiliation': ""Department of Medicine, Centre for Heart Lung Innovation, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}, {'ForeName': 'Niranjan', 'Initials': 'N', 'LastName': 'Kissoon', 'Affiliation': ""Department of Pediatrics, British Columbia Children's Hospital, University of British Columbia, Vancouver, British Columbia, Canada.""}]",Seminars in respiratory and critical care medicine,['10.1055/s-0040-1710320']
2807,32820851,P300-mediated modulations in self-other processing under psychedelic psilocybin are related to connectedness and changed meaning: A window into the self-other overlap.,"The concept of self and self-referential processing has a growing explanatory value in psychiatry and neuroscience, referring to the cognitive organization and perceptual differentiation of self-stimuli in health and disease. Conditions in which selfhood loses its natural coherence offer a unique opportunity for elucidating the mechanisms underlying self-disturbances. We assessed the psychoactive effects of psilocybin (230 μg/kg p.o.), a preferential 5-HT1A/2A agonist known to induce shifts in self-perception. Our placebo-controlled, double-blind, within-subject crossover experiment (n = 17) implemented a verbal self-monitoring task involving vocalizations and participant identification of real-time auditory source- (self/other) and pitch-modulating feedback. Subjective experience and task performance were analyzed, with time-point-by-time-point assumption-free multivariate randomization statistics applied to the spatiotemporal dynamics of event-related potentials. Psilocybin-modulated self-experience, interacted with source to affect task accuracy, and altered the late phase of self-stimuli encoding by abolishing the distinctiveness of self- and other-related electric field configurations during the P300 timeframe. This last effect was driven by current source density changes within the supragenual anterior cingulate and right insular cortex. The extent of the P300 effect was associated with the intensity of psilocybin-induced feelings of unity and changed meaning of percepts. Modulations of late encoding and their underlying neural generators in self-referential processing networks via 5-HT signaling may be key for understanding self-disorders. This mechanism may reflect a neural instantiation of altered self-other and relational meaning processing in a stimulus-locked time domain. The study elucidates the neuropharmacological foundation of subjectivity, with implications for therapy, underscoring the concept of connectedness.",2020,The extent of the P300 effect was associated with the intensity of psilocybin-induced feelings of unity and changed meaning of percepts.,[],"['psilocybin', 'verbal self-monitoring task involving vocalizations and participant identification of real-time auditory source- (self/other) and pitch-modulating feedback']",['Subjective experience and task performance'],[],"[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0042932', 'cui_str': 'Singing, Animal'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0175681', 'cui_str': 'Pitch'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",,0.0230626,The extent of the P300 effect was associated with the intensity of psilocybin-induced feelings of unity and changed meaning of percepts.,"[{'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Smigielski', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kometer', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Scheidegger', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Stress', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Katrin H', 'Initials': 'KH', 'LastName': 'Preller', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Koenig', 'Affiliation': 'Translational Research Center, University Hospital of Psychiatry, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Franz X', 'Initials': 'FX', 'LastName': 'Vollenweider', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging, Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital of Psychiatry, University of Zurich, Zurich, Switzerland.'}]",Human brain mapping,['10.1002/hbm.25174']
2808,32820861,Biosimilarity Assessment of 2 Filgrastim Therapeutics in Healthy Volunteers.,"This study aimed to compare the pharmacokinetic, pharmacodynamic, and safety profiles of a proposed biosimilar and innovator filgrastim therapeutics in healthy volunteers. In a crossover design, 23 subjects received a single subcutaneous injection of 300-µg filgrastim, followed by a 7-day washout period. Assessed pharmacokinetic parameters were the maximum observed filgrastim serum concentration (C max  ), time to reach C max  (t max  ), the area under the concentration-time curve (AUC), and elimination half-life. Pharmacodynamics were assessed by the maximum observed absolute neutrophil count effect (E max  ), t max,E  (time to reach E max  ), and the area under the effect of the absolute neutrophil count -time curve. The test/reference ratio (90% confidence intervals) of C max  of 0.992 (0.860-1.143), AUC 0-inf  of 0.995 (0.891-1.111), E max  of 0.952 (0.841, 1.078), and area under the effect of the absolute neutrophil count -time curve from time zero to 96 hours of 0.939 (0.854-1.032), were all well within the predefined equivalence boundaries of 80% and 125%. Obtained values for t max  (∼4 hours), t max,E  (∼15 hours), and elimination half-life (∼3.5 hours) were comparable between 2 treatment groups. The local tolerability and incidence of adverse events were comparable, with no clinically meaningful difference between biosimilar and innovator products. Altogether, the results suggested a high similarity of the proposed biosimilar to the innovator filgrastim in healthy volunteers.",2020,"The local tolerability and incidence of adverse events were comparable, with no clinically meaningful difference between biosimilar and innovator products.","['Healthy Volunteers', 'healthy volunteers', '23 subjects received a']",['single subcutaneous injection of 300-µg filgrastim'],"['absolute neutrophil count -time curve', 'absolute neutrophil count effect (E max  ), t max,E  (time to reach E max  ), and the area under the effect of the absolute neutrophil count -time curve', 'filgrastim serum concentration (C max  ), time to reach C max  (t max  ), the area under the concentration-time curve (AUC), and elimination half-life', 'local tolerability and incidence of adverse events', 'pharmacokinetic, pharmacodynamic, and safety profiles']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}]","[{'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0210630', 'cui_str': 'Filgrastim'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.023003,"The local tolerability and incidence of adverse events were comparable, with no clinically meaningful difference between biosimilar and innovator products.","[{'ForeName': 'Seyed Reza', 'Initials': 'SR', 'LastName': 'Khandoozi', 'Affiliation': 'Department of Oncology, 5 Azar Hospital, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Shahbazi', 'Affiliation': 'Medical Cellular and Molecular Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Amini', 'Affiliation': 'Medical Cellular and Molecular Research Center, Golestan University of Medical Sciences, Gorgan, Iran.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.856']
2809,32820879,Treating Scalp Psoriasis with Calcipotriol/Betamethasone Dipropionate Fixed-dose Combination Cutaneous Foam: Review of Phase 2 data.,"Two Phase 2 studies investigated the effect of a fixed-dose combination foam containing calcipotriene monohydrate (Cal) and betamethasone dipropionate (BD) on scalp psoriasis in adult and adolescent patients. Patients had psoriasis classified as at least 'mild' per PGA. NCT01536938 enrolled adult patients (≥18 years) randomized 1:1:1 to once-daily (QD) Cal/BD foam (Cal 0.005%, BD 0.064%), Cal foam (0.005%) or BD foam (0.064%). NCT02387853 enrolled adolescent patients (12- <17 years) to Cal/BD foam QD (dose as previously). Treatment success was based on improvement in PGA classification at week 4. Additional efficacy endpoints included mPASI in adults and effect on extent of scalp surface area (SSA) in adolescents. Safety was also assessed. Overall, 302 adults (n=100 Cal/BD foam; n=101 Cal foam; n=101 BD foam) and 106 adolescents received treatment. Treatment success in adults was significantly higher with Cal/BD vs Cal foam (53.0% vs 35.6%, P=0.021) and numerically higher than with BD foam (47.5%, P=0.45). Mean percentage changes in mPASI were -80.0%, -57.8% and -71.2%, for Cal/BD, Cal and BD foam, respectively. In adolescents, 73.6% of patients treated with Cal/BD foam achieved treatment success and mean SSA fell from 50.6% at baseline to 12.5% at week 4. All treatment-related AEs were considered mild-to-moderate across both studies, except one severe AE (hypersensitivity reaction with urticaria) in the adult Cal/BD foam group, which led to withdrawal from the study. In these studies, treatment of scalp psoriasis with Cal/BD foam provided good efficacy for adults and adolescents and was generally well tolerated. J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5168.",2020,"Mean percentage changes in mPASI were -80.0%, -57.8% and -71.2%, for Cal/BD, Cal and BD foam, respectively.","['302 adults (n=100 Cal/BD foam; n=101 Cal foam; n=101 BD foam) and 106 adolescents received treatment', 'adult and adolescent patients', ""Patients had psoriasis classified as at least 'mild' per PGA"", 'NCT01536938 enrolled adult patients (≥18 years', 'NCT02387853 enrolled adolescent patients (12- <17 years) to Cal/BD foam QD (dose as previously', 'adolescents']","['fixed-dose combination foam containing calcipotriene monohydrate (Cal) and betamethasone dipropionate (BD', 'Calcipotriol/Betamethasone Dipropionate', 'Cal/BD']","['Safety', 'tolerated', 'Mean percentage changes in mPASI', 'scalp psoriasis', 'treatment success and mean SSA fell', 'extent of scalp surface area (SSA', 'severe AE (hypersensitivity reaction with urticaria']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3474001', 'cui_str': 'Calcipotriol monohydrate'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3474001', 'cui_str': 'Calcipotriol monohydrate'}, {'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0065767', 'cui_str': 'calcipotriene'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0406326', 'cui_str': 'Scalp psoriasis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2732618', 'cui_str': 'Sessile serrated adenoma'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}]",302.0,0.0618305,"Mean percentage changes in mPASI were -80.0%, -57.8% and -71.2%, for Cal/BD, Cal and BD foam, respectively.","[{'ForeName': 'Bibi', 'Initials': 'B', 'LastName': 'Petersen', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lebwohl', 'Affiliation': ''}]",Journal of drugs in dermatology : JDD,['10.36849']
2810,32820955,Effects of a virtual group cycling experience on people living with dementia: A mixed method pilot study.,"Social isolation and sedentary behaviour are common in residential aged care facilities (also known as nursing homes or long-term care). Use of new technologies such as virtual and augmented reality are currently under investigation for their potential to provide exciting and engaging activities for older people in residential aged care facilities. However, there is limited evidence on whether these technologies can promote physical activity in a small group setting for people with cognitive impairment. Using mixed methods, we examined the use of a virtual cycling experience in a sample of 10 participants with cognitive impairment living in residential aged care facilities. In a randomised crossover design, participants engaged in a 25-minute, self-paced, facilitated seated virtual cycling experience and a time-matched seated physical activity session in groups of five. All participants completed a brief pre- and post-intervention mood questionnaire. Video analysis was used for both conditions to compare levels of environmental stimulation, apathy and engagement using both the Person-Environment Apathy Rating Scale and the Engagement of a Person with Dementia Scale. A thematic analysis of semi-structured interviews following the virtual cycling experience was also performed. No differences were observed between conditions for all outcomes except for environmental stimulation, where there was a lower response in the intervention than the control condition ( p  = 0.032). This was primarily driven by lower scores for the virtual cycling experience than control in physical accessibility ( p  = 0.012). Participants reported the virtual cycling experience to be immersive and challenging and reminisced about cycling earlier in life. The activity manager observed that the virtual cycling experience was an overall positive experience and emphasised benefits of safety screening and preparation prior to the activities. The findings of this study support the use of the virtual cycling experience as an immersive and engaging alternative to usual activities, which might encourage higher levels of physical activity in residential aged care facilities.",2020,"No differences were observed between conditions for all outcomes except for environmental stimulation, where there was a lower response in the intervention than the control condition ( p  = 0.032).","['participants engaged in a 25-minute', 'residential aged care facilities', 'older people in residential aged care facilities', 'people living with dementia', '10 participants with cognitive impairment living in residential aged care facilities', 'people with cognitive impairment']","['self-paced, facilitated seated virtual cycling experience and a time-matched seated physical activity session', 'virtual group cycling experience']","['levels of environmental stimulation, apathy and engagement using both the Person-Environment Apathy Rating Scale and the Engagement of a Person with Dementia Scale']","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0085632', 'cui_str': 'Indifference'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]",10.0,0.0979412,"No differences were observed between conditions for all outcomes except for environmental stimulation, where there was a lower response in the intervention than the control condition ( p  = 0.032).","[{'ForeName': 'Nathan M', 'Initials': 'NM', 'LastName': ""D'Cunha"", 'Affiliation': 'Faculty of Health, 110446University of Canberra, Australia.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Isbel', 'Affiliation': 'Faculty of Health, 110446University of Canberra, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Frost', 'Affiliation': 'Faculty of Health, 110446University of Canberra, Australia.'}, {'ForeName': 'Angie', 'Initials': 'A', 'LastName': 'Fearon', 'Affiliation': 'Faculty of Health, 110446University of Canberra, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'McKune', 'Affiliation': 'Faculty of Health, 110446University of Canberra, Australia; Discipline of Sport and Exercise Science, Research Institute for Sport and Exercise, Faculty of Health, 110446University of Canberra, Australia; Discipline of Biokinetics, Exercise and Leisure Sciences, School of Health Sciences, 56394University of KwaZulu-Natal, South Africa.'}, {'ForeName': 'Nenad', 'Initials': 'N', 'LastName': 'Naumovski', 'Affiliation': 'Faculty of Health, 110446University of Canberra, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kellett', 'Affiliation': 'Faculty of Health, 110446University of Canberra, Australia.'}]","Dementia (London, England)",['10.1177/1471301220951328']
2811,32821255,Effects of fish oil during hemodialysis on nutritional status and quality of life: a randomized double-blinded trial.,"Background


Supplementation of fish oil has been shown to exert beneficial effects in patients undergoing hemodialysis. The aim of this study was to investigate the efficacy of fish oil in improving the quality of life of these patients through a randomized, double-blinded clinical trial.
Methods


Among the 103 patients enrolled in the study, a total of 74 patients were randomized to receive fish oil (intervention group) or placebo ( n =37 per group). Patients received identical soft-gel capsules, with each capsule containing either 1000 mg fish oil or placebo for 4 months. Personnel responsible for data collection and analyses were blinded to the grouping.
Results


The reduction of protein-energy wasting (PEW) in the intervention group was significantly more prominent compared to the placebo group ( P =0.023). The intervention group demonstrated significant increase in midarm circumference, arm muscle circumference, and triceps skinfold thickness after fish oil intake. The intervention group also exhibited significant differences from the placebo group in creatinine, uric acid, and serum calcium levels. Significant improvement was seen regarding the physical role and energy/figure in the intervention group.
Conclusions


Our study demonstrated that fish oil intake in patient undergoing hemodialysis can significantly reduce PEW, and improve physical and biochemical parameters and quality of life, which could provide guidance to clinical management of these patients.",2020,"The intervention group demonstrated significant increase in midarm circumference, arm muscle circumference, and triceps skinfold thickness after fish oil intake.","['103 patients enrolled in the study, a total of 74 patients', 'patient undergoing hemodialysis', 'patients undergoing hemodialysis']","['fish oil (intervention group) or placebo', 'fish oil', 'identical soft-gel capsules, with each capsule containing either 1000 mg fish oil or placebo', 'placebo']","['quality of life', 'nutritional status and quality of life', 'creatinine, uric acid, and serum calcium levels', 'physical and biochemical parameters and quality of life', 'reduction of protein-energy wasting (PEW', 'physical role and energy/figure', 'midarm circumference, arm muscle circumference, and triceps skinfold thickness']","[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0205358', 'cui_str': 'Soft'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C1883310', 'cui_str': '1000'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0728876', 'cui_str': 'Serum calcium measurement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006625', 'cui_str': 'Cachexia'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518022', 'cui_str': 'Triceps skin fold thickness'}]",74.0,0.659958,"The intervention group demonstrated significant increase in midarm circumference, arm muscle circumference, and triceps skinfold thickness after fish oil intake.","[{'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Xuzhou Medical University, Jiangsu, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Ge', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, The Affiliated Suqian Hospital of Xuzhou Medical University, Jiangsu, China.'}, {'ForeName': 'Junsheng', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, The Affiliated Suqian Hospital of Xuzhou Medical University, Jiangsu, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Nephrology, Xuzhou Medical University, Jiangsu, China.'}]",Food & nutrition research,['10.29219/fnr.v64.4450']
2812,32821284,Combined Aerobic and Resistance Exercises Evokes Longer Reductions on Ambulatory Blood Pressure in Resistant Hypertension: A Randomized Crossover Trial.,"Aim


The present study compared the acute effects of aerobic (AER), resistance (RES), and combined (COM) exercises on blood pressure (BP) levels in people with resistant hypertension (RH) and nonresistant hypertension (NON-RH).
Methods


Twenty patients (10 RH and 10 NON-RH) were recruited and randomly performed three exercise sessions and a control session. Ambulatory BP was monitored over 24 hours after each experimental session.
Results


Significant reductions on ambulatory BP were found in people with RH after AER, RES, and COM sessions. Notably, ambulatory BP was reduced during awake-time and night-time periods after COM. On the other hand, the effects of AER were more prominent during awake periods, while RES caused greater reductions during the night-time period. In NON-RH, only RES acutely reduced systolic BP, while diastolic BP was reduced after all exercise sessions. However, the longest postexercise ambulatory hypotension was observed after AER (~11 h) in comparison to RES (~8 h) and COM (~4 h) exercises.
Conclusion


Findings of the present study indicate that AER, RES, and COM exercises elicit systolic and diastolic postexercise ambulatory hypotension in RH patients. Notably, longer hypotension periods were observed after COM exercise. In addition, NON-RH and RH people showed different changes on BP after exercise sessions, suggesting that postexercise hypotension is influenced by the pathophysiological bases of hypertension.",2020,"Significant reductions on ambulatory BP were found in people with RH after AER, RES, and COM sessions.","['Twenty patients (10 RH and 10 NON-RH', 'Resistant Hypertension', 'people with resistant hypertension (RH) and nonresistant hypertension (NON-RH', 'RH patients']","['exercise sessions and a control session', 'Combined Aerobic and Resistance Exercises Evokes', 'aerobic (AER), resistance (RES), and combined (COM) exercises']","['AER, RES, and COM exercises elicit systolic and diastolic postexercise ambulatory hypotension', 'BP', 'ambulatory BP', 'Ambulatory Blood Pressure', 'systolic BP, while diastolic BP', 'longest postexercise ambulatory hypotension', 'longer hypotension periods', 'postexercise hypotension', 'Ambulatory BP', 'blood pressure (BP) levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}]","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2936233', 'cui_str': 'Post Exercise Hypotension'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0262751,"Significant reductions on ambulatory BP were found in people with RH after AER, RES, and COM sessions.","[{'ForeName': 'Nayara Fraccari', 'Initials': 'NF', 'LastName': 'Pires', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Helio José', 'Initials': 'HJ', 'LastName': 'Coelho-Júnior', 'Affiliation': 'Laboratory of Cardiovascular Investigation and Exercise, School of Physical Education (FEF), University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Bruno Bavaresco', 'Initials': 'BB', 'LastName': 'Gambassi', 'Affiliation': 'Laboratory of Cardiovascular Investigation and Exercise, School of Physical Education (FEF), University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Ana Paula Cabral', 'Initials': 'APC', 'LastName': 'de Faria', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Alessandra Mileni Versuti', 'Initials': 'AMV', 'LastName': 'Ritter', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'de Andrade Barboza', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Silvia Elaine', 'Initials': 'SE', 'LastName': 'Ferreira-Melo', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Rodrigues', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Heitor Moreno', 'Initials': 'HM', 'LastName': 'Júnior', 'Affiliation': 'Laboratory of Cardiovascular Pharmacology, School of Medical Sciences, University of Campinas (UNICAMP), Campinas, Brazil.'}]",Cardiovascular therapeutics,['10.1155/2020/8157858']
2813,32821287,Comparison of the effect of clarithromycin triple therapy with or without  N -acetylcysteine in the eradication of  Helicobacter pylori : a randomized controlled trial.,"Background


Whether adjunctive  N -acetylcysteine (NAC) may improve the efficacy of triple therapy in the first-line treatment of  Helicobacter pylori  infection remains unknown. Our aim was to compare the efficacy of 14-day triple therapy with or without NAC for the first-line treatment of  H. pylori .
Material and methods


Between 1 January 2014 and 30 June 2018, 680 patients with  H. pylori  infection naïve to treatment were enrolled in this multicenter, open-label, randomized trial. Patients were randomly assigned to receive triple therapy with NAC [NAC-T14, dexlansoprazole 60 mg four times daily (q.d.); amoxicillin 1 g twice daily (b.i.d.), clarithromycin 500 mg b.i.d., NAC 600 mg b.i.d.] for 14 days, or triple therapy alone (T14, dexlansoprazole 60 mg q.d.; amoxicillin 1 g b.i.d., clarithromycin 500 mg b.i.d.) for 14 days. Our primary outcome was the eradication rates by intention to treat (ITT). Antibiotic resistance and  CYP2C19  gene polymorphism were determined.
Results


The ITT analysis demonstrated  H. pylori  eradication rates in NAC-T14 and T14 were 81.7% [276/338, 95% confidence interval (CI): 77.5-85.8%] and 84.3% (285/338, 95% CI 80.4-88.2%), respectively. In 646 participants who adhered to their assigned therapy, the eradication rates were 85.7% and 88.0% with NAC-T14 and T14 therapies, respectively. There were no differences in compliance or adverse effects. The eradication rates in subjects with clarithromycin-resistant, amoxicillin-resistant, or either clarithromycin/amoxicillin resistant strains were 45.2%, 57.9%, and 52.2%, respectively, for NAC-T14, and were 66.7%, 76.9%, and 70.0%, respectively, for T14. The efficacy of NAC-T14 and T14 was not affected by  CYP2C19  polymorphism.
Conclusion


Add-on NAC to triple therapy was not superior to triple therapy alone for first-line  H. pylori  eradication [ClinicalTrials.gov identifier: NCT02249546].",2020,"The eradication rates in subjects with clarithromycin-resistant, amoxicillin-resistant, or either clarithromycin/amoxicillin resistant strains were 45.2%, 57.9%, and 52.2%, respectively, for NAC-T14, and were 66.7%, 76.9%, and 70.0%, respectively, for T14.","['subjects with clarithromycin-resistant, amoxicillin-resistant, or either', 'Between 1 January 2014 and 30 June 2018, 680 patients with  H. pylori  infection naïve to treatment', 'Helicobacter pylori ', '646 participants who adhered to their assigned therapy, the']","['adjunctive  N -acetylcysteine (NAC', 'clarithromycin triple therapy with or without  N -acetylcysteine', 'clarithromycin 500\u2009mg b.i.d., NAC 600\u2009mg b.i.d.] for 14\u2009days, or triple therapy alone (T14, dexlansoprazole 60\u2009mg q.d.; amoxicillin', 'triple therapy with NAC [NAC-T14, dexlansoprazole 60\u2009mg four times daily (q.d.); amoxicillin', 'clarithromycin/amoxicillin', 'clarithromycin']","['compliance or adverse effects', 'H. pylori  eradication rates', 'Antibiotic resistance and  CYP2C19  gene polymorphism', 'eradication rates by intention to treat (ITT', 'eradication rates']","[{'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2608717', 'cui_str': 'dexlansoprazole 60 MG'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0949285', 'cui_str': 'Antibiotic Resistance'}, {'cui': 'C0960580', 'cui_str': 'CYP2C19 protein, human'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}]",680.0,0.0856568,"The eradication rates in subjects with clarithromycin-resistant, amoxicillin-resistant, or either clarithromycin/amoxicillin resistant strains were 45.2%, 57.9%, and 52.2%, respectively, for NAC-T14, and were 66.7%, 76.9%, and 70.0%, respectively, for T14.","[{'ForeName': 'Chieh-Chang', 'Initials': 'CC', 'LastName': 'Chen', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Jiing-Chyuan', 'Initials': 'JC', 'LastName': 'Luo', 'Affiliation': 'Department of Medicine, National Yang-Ming University, School of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yu-Jen', 'Initials': 'YJ', 'LastName': 'Fang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Ji-Yuh', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, College of Medicine, National Taiwan University Yun-Lin, Yun-Lin, Taiwan.'}, {'ForeName': 'Chia-Chi', 'Initials': 'CC', 'LastName': 'Kuo', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, College of Medicine, National Taiwan University Yun-Lin, Yun-Lin, Taiwan.'}, {'ForeName': 'Tsung-Hua', 'Initials': 'TH', 'LastName': 'Yang', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, College of Medicine, National Taiwan University Yun-Lin, Yun-Lin, Taiwan.'}, {'ForeName': 'Min-Chin', 'Initials': 'MC', 'LastName': 'Chiu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, College of Medicine, National Taiwan University Yun-Lin, Yun-Lin, Taiwan.'}, {'ForeName': 'Jian-Jyun', 'Initials': 'JJ', 'LastName': 'Yu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, College of Medicine, National Taiwan University Yun-Lin, Yun-Lin, Taiwan.'}, {'ForeName': 'Ming-Jong', 'Initials': 'MJ', 'LastName': 'Bair', 'Affiliation': 'Department of Internal Medicine, Taitung Mackay Memorial Hospital, Taitung, Taiwan.'}, {'ForeName': 'Po-Yueh', 'Initials': 'PY', 'LastName': 'Chen', 'Affiliation': 'Department of Internal Medicine, Chia-Yi Christian Hospital, Chia-Yi, Taiwan.'}, {'ForeName': 'Chu-Kuang', 'Initials': 'CK', 'LastName': 'Chou', 'Affiliation': 'Department of Internal Medicine, Chia-Yi Christian Hospital, Chia-Yi, Taiwan.'}, {'ForeName': 'Chi-Yi', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Department of Internal Medicine, Chia-Yi Christian Hospital, Chia-Yi, Taiwan.'}, {'ForeName': 'Chi-Yang', 'Initials': 'CY', 'LastName': 'Chang', 'Affiliation': 'School of Medicine, College of Medicine, Fu Jen Catholic University, New Taipei City, Taiwan.'}, {'ForeName': 'Yao-Chun', 'Initials': 'YC', 'LastName': 'Hsu', 'Affiliation': 'Department of Internal Medicine, E-DA Hospital and I-Shou University, Kaohsiung County, Taiwan.'}, {'ForeName': 'Cheng-Hao', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Department of Internal Medicine, E-DA Cancer Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Wen-Feng', 'Initials': 'WF', 'LastName': 'Hsu', 'Affiliation': 'Division of Gastroenterology and Hepatology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wen-Hao', 'Initials': 'WH', 'LastName': 'Hu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Hsin-Chu Branch, Hsin-Chu, Taiwan.'}, {'ForeName': 'Min-Horn', 'Initials': 'MH', 'LastName': 'Tsai', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Hsin-Chu Branch, Hsin-Chu, Taiwan.'}, {'ForeName': 'Cheng-Lin', 'Initials': 'CL', 'LastName': 'Hsieh', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Hsin-Chu Branch, Hsin-Chu, Taiwan.'}, {'ForeName': 'Mei-Jyh', 'Initials': 'MJ', 'LastName': 'Chen', 'Affiliation': 'Division of Gastroenterology and Hepatology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chia-Tung', 'Initials': 'CT', 'LastName': 'Shun', 'Affiliation': 'Department of Pathology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Tzeng-Ying', 'Initials': 'TY', 'LastName': 'Liu', 'Affiliation': 'Health Bureau of Lienchiang County, Nangan Hsiang, Lienchiang County, Matsu, Taiwan.'}, {'ForeName': 'Yi-Chia', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Division of Gastroenterology and Hepatology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Jyh-Ming', 'Initials': 'JM', 'LastName': 'Liou', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, No. 7, Chung-Shan S. Road, Taipei Taiwan.'}, {'ForeName': 'Ming-Shiang', 'Initials': 'MS', 'LastName': 'Wu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, No. 7, Chung-Shan S. Road, Taipei Taiwan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Therapeutic advances in gastroenterology,['10.1177/1756284820927306']
2814,32821459,"The Effect of the Modified Thoracolumbar Interfacial Nerve Plane Block on Postoperative Analgesia and Healing Quality in Patients Undergoing Lumbar Disk Surgery: A Prospective, Randomized Study.","Objective


The purpose of this study was to investigate the effect of the modified thoracolumbar interfascial plane block (TLIP) on postoperative analgesia and quality of recovery in patients undergoing lumbar disk surgery.
Method


Ninety patients scheduled for lumbar disk surgery were divided into a control group (Group C) and a modified TLIP block group (Group T). Controlled analgesia was administered to both groups. Pain evaluation was performed at 30 min and at 1., 2., 4., 8.,12., and 24. hrs using a VAS scale, with patients at rest and duringand patients completed the QoR-40 quality of recovery inventory.
Results


Fentanyl used during postoperative 24 hours was 742.5±220.3 mcg in Group C and 446.0±241.98 in Group T. Postoperative fentanyl consumption was statistically significantly lower in Group T (p<0.001) with a statistically significant intergroup difference. The patient's pain, physical independence, physical comfort, psychological support, and emotional support were compared using the QoR-40 questionnaire survey. Significant differences in favor of Group T were observed (p<0.001, p=0.017, p=0.002, p=0.001 and p<0.001, respectively). Static and dynamic pain scores in Group C and Group T were recorded at 30 min and at 1, 2, 4, 8, 12, and 24 h . Mean static scores were statistically significantly different in favor of Group T with the exception of 8 th  and 12 h  assessments (p<0.05). Dynamic scores were statistically significantly different in favor of Group T at all time points (p<0.05).
Conclusion


Pain scores, opioid consumption and QoR-40 values after lumbar disk surgery were superior in the group undergoing TLIP. We think that the modified TLIP block may be an important method in terms of postoperative analgesia and patient recovery for lumbar spinal disk surgery.",2019,Group T. Postoperative fentanyl consumption was statistically significantly lower in Group T (p<0.001) with a statistically significant intergroup difference.,"['Patients Undergoing Lumbar Disk Surgery', 'Method\n\n\nNinety patients scheduled for lumbar disk surgery', 'patients undergoing lumbar disk surgery']","['Modified Thoracolumbar Interfacial Nerve Plane Block', 'modified thoracolumbar interfascial plane block (TLIP', 'modified TLIP block']","[""patient's pain, physical independence, physical comfort, psychological support, and emotional support"", 'Postoperative fentanyl consumption', 'Mean static scores', 'QoR-40 quality of recovery inventory', 'Postoperative Analgesia and Healing Quality', 'Static and dynamic pain scores', 'Dynamic scores', 'Pain scores, opioid consumption and QoR-40 values', 'Pain evaluation', 'postoperative analgesia and quality of recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0600015', 'cui_str': 'Emotional support'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",90.0,0.052138,Group T. Postoperative fentanyl consumption was statistically significantly lower in Group T (p<0.001) with a statistically significant intergroup difference.,"[{'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Ozmen', 'Affiliation': 'Ataturk University, School of Medicine, Department of Anaesthesiology and Reanimation, Erzurum, Turkey.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Ince', 'Affiliation': 'Ataturk University, School of Medicine, Department of Anaesthesiology and Reanimation, Erzurum, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Aksoy', 'Affiliation': 'Ataturk University, School of Medicine, Department of Anaesthesiology and Reanimation, Erzurum, Turkey.'}, {'ForeName': 'Aysenur', 'Initials': 'A', 'LastName': 'Dostbil', 'Affiliation': 'Ataturk University, School of Medicine, Department of Anaesthesiology and Reanimation, Erzurum, Turkey.'}, {'ForeName': 'Canan', 'Initials': 'C', 'LastName': 'Atalay', 'Affiliation': 'Ataturk University, School of Medicine, Department of Anaesthesiology and Reanimation, Erzurum, Turkey.'}, {'ForeName': 'Kamber', 'Initials': 'K', 'LastName': 'Kasali', 'Affiliation': 'Ataturk University, School of Medicine, Department of Biostatistics, Erzurum, Turkey.'}]",Medeniyet medical journal,['10.5222/MMJ.2019.36776']
2815,32821460,Comparison of General Anesthesia with Spinal Anesthesia in Laparoscopic Cholecystectomy Operations.,"Objective


Laparoscopic cholecystectomy (LC) operations are being performed under general anesthesia (GA). Further studies are needed on the issue whether these operations can be performed under spinal anesthesia (SA). In this study we aimed to compare SA with (GA) in terms of efficacy and complications in patients who will undergo LC operations, and to investigate the effects of preemptive analgesia on the development of shoulder pain, transition to general anesthesia, and postoperative analgesia.
Method


Sixty patients in ASA I-II risk group between 18-65 years of age undergoing laparoscopic cholecystectomy were randomly divided into general anesthesia (GA, n=30) and spinal anesthesia (SA, n=30) groups. Patients were premedicated with i.v. midazolam and fentanyl preoperatively. Anesthesia was induced with propofol in the GA group, and maintained with Desflurane and remifentanil. In the SA group, spinal anesthesia was provided with intratechal administration of 15 mg bupivacaine at L2-3 level, and block level was increased to T4 by keeping the patient in Trendelenburg position for 7-10 minutes. Demographic data, hemodynamic parameters, operation time, visual analog scale (VAS) scores at postoperative 0 th ,1 st , 4 th , 8 th ,12 th  and 24 th  hours, patient-surgeon satisfaction, side effects, and occurrence of right shoulder pain in SA group were inquired and recorded.
Results


Effective anesthesia was produced in both groups. Hypotension was observed in 5, bradycardia requiring atropin administration in 4, and perioperative shoulder pain in 9 patients in Group SA, but none of them required general anesthesia. Hypotension developed in one patient in Group GA. The postoperative VAS scores were significantly lower in Group SA at 0 th ,1 st , 4 th  hours. Patient satisfection scores were higher in Group SA.
Conclusion


We concluded that spinal anesthesia may be an alternative method to general anesthesia in patients who will undergo laparoscopic cholecystectomy operations especially when the risk of general anesthesia is too high.",2019,"The postoperative VAS scores were significantly lower in Group SA at 0 th ,1 st , 4 th  hours.","['patients who will undergo LC operations', 'patients who will undergo laparoscopic cholecystectomy operations', 'Method\n\n\nSixty patients in ASA I-II risk group between 18-65 years of age undergoing laparoscopic cholecystectomy', 'Laparoscopic Cholecystectomy Operations']","['propofol', 'bupivacaine', 'General Anesthesia with Spinal Anesthesia', 'general anesthesia (GA, n=30) and spinal anesthesia', 'Desflurane and remifentanil', 'midazolam', 'SA with (GA', 'Laparoscopic cholecystectomy (LC) operations']","['efficacy and complications', 'Demographic data, hemodynamic parameters, operation time, visual analog scale (VAS) scores', 'Patient satisfection scores', 'postoperative VAS scores', 'perioperative shoulder pain', 'Hypotension', 'patient-surgeon satisfaction, side effects, and occurrence of right shoulder pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0241040', 'cui_str': 'Pain of right shoulder joint'}]",,0.0185863,"The postoperative VAS scores were significantly lower in Group SA at 0 th ,1 st , 4 th  hours.","[{'ForeName': 'Alperen', 'Initials': 'A', 'LastName': 'Kisa', 'Affiliation': 'Hitit University Erol Olcok Education and Research Hospital, Department Anesthesiology and Reanimation, Istanbul, Turkey.'}, {'ForeName': 'Senem', 'Initials': 'S', 'LastName': 'Koruk', 'Affiliation': 'Istanbul Medeniyet University, Goztepe Training and Research Hospital, Department of Anesthesiology and Reanimation, Istanbul, Turkey.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Kocoglu', 'Affiliation': 'Istanbul Medeniyet University, Goztepe Training and Research Hospital, Department of Anesthesiology and Reanimation, Istanbul, Turkey.'}, {'ForeName': 'İhsan Metin', 'Initials': 'İM', 'LastName': 'Leblebici', 'Affiliation': 'Istanbul Medeniyet University, Goztepe Training and Research Hospital, Department of General Surgery, Istanbul, Turkey.'}]",Medeniyet medical journal,['10.5222/MMJ.2019.37929']
2816,32821465,Effects of Bispectral Index-controlled Use of Magnesium on Propofol Consumption and Sedation Level in Patients Undergoing Colonoscopy.,"Objective


The aim of this study is to investigate the effects of bispectral index-controlled use of magnesium on propofol consumption, periprocedural hemodynamic response and patient comfort.
Material


A total of 60 patients were enrolled in the study. In Group 1 (magnesium), a single dose 50 mg/kg magnesium sulfate diluted with 100 mL 0.9% NaCl was administered 10 minutes before the beginning of the procedure. Initially bolus dose of 0.5 mg/kg propofol was applied. The maintenance dose of propofol was 60 mcg/kg/min. During the procedure, the propofol infusion was increased by titration until the bispectral index (BIS) value of 70 was achieved. In Group 2 (saline), 100 ml 0.9% NaCl was administered 10 minutes before the beginning of the procedure. The bolus and maintenance doses of propofol, and target BIS values were the same as those in Group 1.
Results


When BIS values were compared between the groups, the initial BIS values in the magnesium group (Group 1) were significantly higher than those of the saline group (Group 2) (p<0.05). The time to reach BIS 70 was significantly shorter in the magnesium group (p<0.05). Propofol consumption was greater in Group 2 than in Group 1 (p<0.05). The time to reach BIS 70 was significantly shorter in Group 1 (p<0.05). No significant difference was found between the groups in terms of patient- and endoscopist-satisfaction (p<0.05).
Conclusion


The use of magnesium in addition to propofol may be an efficient and reliable option to reduce the drug consumption during colonoscopic interventions.",2019,The time to reach BIS 70 was significantly shorter in the magnesium group (p<0.05).,"['Patients Undergoing Colonoscopy', '60 patients were enrolled in the study']","['Magnesium', 'Material', 'magnesium sulfate diluted with 100 mL 0.9% NaCl', 'propofol', 'magnesium']","['Propofol consumption', 'titration until the bispectral index (BIS) value', 'patient- and endoscopist-satisfaction (p<0.05', 'initial BIS values', 'time to reach BIS', 'Propofol Consumption and Sedation Level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.0513658,The time to reach BIS 70 was significantly shorter in the magnesium group (p<0.05).,"[{'ForeName': 'Hamit', 'Initials': 'H', 'LastName': 'Yoldas', 'Affiliation': 'Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Anesthesiology and Reanimation, Bolu, Turkey.'}, {'ForeName': 'Isa', 'Initials': 'I', 'LastName': 'Yildiz', 'Affiliation': 'Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Anesthesiology and Reanimation, Bolu, Turkey.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Karagoz', 'Affiliation': 'Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Anesthesiology and Reanimation, Bolu, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Sit', 'Affiliation': 'Bolu Abant Izzet Baysal University Faculty of Medicine, Department of General Surgery, Bolu, Turkey.'}, {'ForeName': 'Muhammed Nur', 'Initials': 'MN', 'LastName': 'Ogun', 'Affiliation': 'Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Neurology, Bolu, Turkey.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Demirhan', 'Affiliation': 'Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Anesthesiology and Reanimation, Bolu, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Bilgi', 'Affiliation': 'Bolu Abant Izzet Baysal University Faculty of Medicine, Department of Anesthesiology and Reanimation, Bolu, Turkey.'}]",Medeniyet medical journal,['10.5222/MMJ.2019.99705']
2817,32821494,Histologic Changes Following Continuous Wave and Micropulse Transscleral Cyclophotocoagulation: A Randomized Comparative Study.,"Purpose


To compare the macroscopic and microscopic histologic changes in eyes treated with micropulse transscleral cyclophotocoagulation (MP-TCP) versus continuous wave transscleral cyclophotocoagulation (CW-TCP).
Methods


Twelve halves of globes from three pairs of adult cadaveric eyes were randomly assigned to nontreated control, CW-TCP, single MP-TCP treatment, or double MP-TCP treatments, and then sectioned for histologic analysis. Presence or absence of the following four unique histologic changes was recorded: splitting within the ciliary process epithelium (splitting), separation of the pigmented ciliary process epithelium from the stroma (separation), coagulation of collagen and destruction of ciliary process stroma (coagulation), and full-thickness destruction of ciliary process epithelium (destruction).
Results


A total of 498 slides were analyzed, and laser scars in all treated specimens were located in the pars plana. Logistic regression analysis showed that compared with controls, CW-TCP-treated specimens were significantly more likely to experience separation (odds ratio [OR] = 11.1,  P  = 0.02), coagulation (OR = 24.3,  P  = 0.002), and destruction (OR = 11.1,  P  = 0.03). Destruction of the ciliary process epithelium was observed exclusively in CW-TCP-treated sections. No significant differences in histologic features were observed between controls and MP-TCP.
Conclusions


MP-TCP does not produce significant histologic changes in cadaveric eyes, whereas CW-TCP treatment does.
Translational Relevance


These findings improve understanding of the mechanism of MP-TCP, help explain the increased rates of adverse effects following CW-TCP treatment compared with MP-TCP, and describe effects of MP-TCP at various doses.",2020,"Logistic regression analysis showed that compared with controls, CW-TCP-treated specimens were significantly more likely to experience separation (odds ratio [OR] = 11.1,  P  = 0.02), coagulation (OR = 24.3,  P  = 0.002), and destruction (OR = 11.1,  P  = 0.03).","['eyes treated with', 'Methods\n\n\nTwelve halves of globes from three pairs of adult cadaveric eyes']","['Continuous Wave and Micropulse Transscleral Cyclophotocoagulation', 'micropulse transscleral cyclophotocoagulation (MP-TCP) versus continuous wave transscleral cyclophotocoagulation (CW-TCP', 'CW-TCP', 'nontreated control, CW-TCP, single MP-TCP treatment, or double MP-TCP treatments']","['Destruction of the ciliary process epithelium', 'Histologic Changes', 'histologic features', 'coagulation', 'macroscopic and microscopic histologic changes']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0395490', 'cui_str': 'Photocoagulation of ciliary body'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C1261381', 'cui_str': 'Destructive procedure'}, {'cui': 'C1261761', 'cui_str': 'Structure of ciliary processes'}, {'cui': 'C0014609', 'cui_str': 'Epithelium'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0205288', 'cui_str': 'Microscopic'}]",498.0,0.0289074,"Logistic regression analysis showed that compared with controls, CW-TCP-treated specimens were significantly more likely to experience separation (odds ratio [OR] = 11.1,  P  = 0.02), coagulation (OR = 24.3,  P  = 0.002), and destruction (OR = 11.1,  P  = 0.03).","[{'ForeName': 'Kareem', 'Initials': 'K', 'LastName': 'Moussa', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Feinstein', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Melike', 'Initials': 'M', 'LastName': 'Pekmezci', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Jun Hui', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Bloomer', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Oldenburg', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Lee', 'Affiliation': 'Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Gui-Shuang', 'Initials': 'GS', 'LastName': 'Ying', 'Affiliation': 'Department of Ophthalmology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, USA.'}]",Translational vision science & technology,['10.1167/tvst.9.5.22']
2818,32826450,Stent strut thickness and acute vessel injury during percutaneous coronary interventions: an optical coherence tomography randomized clinical trial.,"AIMS


Compare the degree of acute vascular injury caused by a polymer-free, thin-strut drug-eluting stent (DES) to that caused by a bioresorbable polymer, thick-strut DES using optical coherence tomography (OCT).
METHODS AND RESULTS


Fifty patients requiring nonurgent PCI were randomized to receive either a thin or a thick-strut DES. OCT was performed before and after stent implantation. OCT-based injury score (IS) after implantation was numerically higher within thick-strut stents 0.32 vs. 0.23, but the difference was NS (P = 0.61). Edge dissections were present in 36% of the patients without differences between groups. Tissue prolapse (TP) area was larger with thin-strut stents (2.26 vs. 1.83 mm, P = 0.04). Stent expansion and symmetry index were similar between the two platforms (85% vs. 94%, P = 0.08; and 0.82 vs. 0.80, P = 0.25). No differences were observed in total malapposition area (1.85 mm in thin-strut stents vs. 1.47 mm, P = 0.48). Regarding the influence of plaque-type, IS tended to be higher (non-significant) with thick strut DES in fibrocalcific plaques. Stent malapposition area was smaller in fibrous plaques, especially with thin strut stents (P = 0.03).
CONCLUSION


There was no difference in the extent of OCT-based vessel injury associated with thin and thick-strut DES platforms. TP was larger with the thin strut DES, potentially reflecting a deeper stent embedment in the vessel wall.",2020,"Stent malapposition area was smaller in fibrous plaques, especially with thin strut stents (P = 0.03).
",['Fifty patients requiring nonurgent PCI'],"['percutaneous coronary interventions', 'OCT', 'polymer-free, thin-strut drug-eluting stent (DES']","['total malapposition area', 'Tissue prolapse (TP) area', 'Stent expansion and symmetry index', 'OCT-based injury score (IS) after implantation', 'Stent malapposition area']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0032521', 'cui_str': 'Polymer'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0441295', 'cui_str': 'Strut'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C2363858', 'cui_str': 'Stent malapposition'}]",50.0,0.0927455,"Stent malapposition area was smaller in fibrous plaques, especially with thin strut stents (P = 0.03).
","[{'ForeName': 'Jean Paul', 'Initials': 'JP', 'LastName': 'Vilchez-Tschischke', 'Affiliation': 'Interventional Cardiology, Hospital Clínico San Carlos.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Salazar', 'Affiliation': 'Interventional Cardiology, Hospital Clínico San Carlos.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Gil-Romero', 'Affiliation': 'Interventional Cardiology, Hospital Clínico San Carlos.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Mori', 'Affiliation': 'Interventional Cardiology, Hospital Clínico San Carlos.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Nuñez-Gil', 'Affiliation': 'Interventional Cardiology, Hospital Clínico San Carlos.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Quirós', 'Affiliation': 'Universidad de León, León.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Nombela', 'Affiliation': 'Interventional Cardiology, Hospital Clínico San Carlos.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Del Trigo', 'Affiliation': 'Interventional Cardiology, Hospital Clínico San Carlos.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Jimenez-Quevedo', 'Affiliation': 'Interventional Cardiology, Hospital Clínico San Carlos.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Salinas', 'Affiliation': 'Interventional Cardiology, Hospital Clínico San Carlos.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Interventional Cardiology, Hospital Clínico San Carlos.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Macaya', 'Affiliation': 'Interventional Cardiology, Hospital Clínico San Carlos.'}, {'ForeName': 'Nieves', 'Initials': 'N', 'LastName': 'Gonzalo', 'Affiliation': 'Interventional Cardiology, Hospital Clínico San Carlos.'}]",Coronary artery disease,['10.1097/MCA.0000000000000943']
2819,32826543,The Impact of Receiving a Family-Oriented Therapeutic Conversation Intervention Before and During Bereavement Among Family Cancer Caregivers: A Nonrandomized Trial.,"Effective communication is the foundation of quality care in palliative nursing. As frontline palliative home care providers, nurses could foster more effective bereavement coping skills through therapeutic conversations. The purpose of this study was to evaluate the impact of a nursing intervention offered to bereaved family cancer caregivers. This was a quasi-experimental design, with a posttest-only comparison of the intervention and control groups receiving usual care. Bereaved caregivers (n = 51) receiving services from a specialized palliative home care unit participated and completed measures of depression, anxiety, stress, and grief reactions 3, 5, and 6 months after their close relative had died.There was a significant decrease in anxiety symptoms in the intervention group compared with the control group across all 3 time points. Anxiety and stress symptoms also decreased over time in the 2 groups combined, but this decrease was not observed for depression. When evaluating grief reactions, the intervention group had a lower mean of controlled grief responses, across the posttest period, than the control group.Results demonstrate that providing bereaved family caregivers the opportunity to participate in a therapeutic conversation intervention might reduce distressing symptoms in early bereavement.",2020,"When evaluating grief reactions, the intervention group had a lower mean of controlled grief responses, across the posttest period, than the control group.","['Family Cancer Caregivers', 'bereaved family cancer caregivers', 'Bereaved caregivers (n = 51) receiving services from a specialized palliative home care unit participated and completed', 'palliative nursing']","['Receiving a Family-Oriented Therapeutic Conversation Intervention', 'control groups receiving usual care', 'nursing intervention']","['controlled grief responses', 'anxiety symptoms', 'Anxiety and stress symptoms', 'distressing symptoms', 'measures of depression, anxiety, stress, and grief reactions']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3816218', 'cui_str': 'Palliative Care Nursing'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018235', 'cui_str': 'Normal grief reaction'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",51.0,0.0187652,"When evaluating grief reactions, the intervention group had a lower mean of controlled grief responses, across the posttest period, than the control group.","[{'ForeName': 'Asta B', 'Initials': 'AB', 'LastName': 'Petursdottir', 'Affiliation': 'Asta B. Petursdottir, PhD, RN, School of Health Sciences, University of Iceland; Palliative Care Unit, Landspitali - The National University Hospital, Reykjavík, Iceland; and Faculty of Nursing, School of Health Sciences, Faculty of Nursing at the University of Iceland. Valgerdur Sigurdardottir, MD, PhD, Palliative Care Unit, Landspitali - The National University Hospital, Reykjavík, Iceland; and clinical lector, School of Health Sciences, University of Iceland, Iceland. Mary Kay Rayens, PhD, University of Kentucky, Lexington. Erla Kolbrun Svavarsdottir, PhD, RN, FAAN, is professor at the School of Health Sciences, Faculty of Nursing at the University of Iceland and the Head of Research and Development in Family Nursing at Landspitali the National University Hospital in Reykjavik, Iceland.'}, {'ForeName': 'Valgerdur', 'Initials': 'V', 'LastName': 'Sigurdardottir', 'Affiliation': ''}, {'ForeName': 'Mary Kay', 'Initials': 'MK', 'LastName': 'Rayens', 'Affiliation': ''}, {'ForeName': 'Erla Kolbrun', 'Initials': 'EK', 'LastName': 'Svavarsdottir', 'Affiliation': ''}]",Journal of hospice and palliative nursing : JHPN : the official journal of the Hospice and Palliative Nurses Association,['10.1097/NJH.0000000000000679']
2820,32826624,"Double standards: why is pulse oximetry standard care, whereas tissue oximetry is not?","PURPOSE OF REVIEW


Why is pulse oximetry a standard monitor, whereas tissue oximeter is not? Is this a double-standard treatment?
RECENT FINDINGS


There appears to be a lack of enthusiasm for a continual investigation into whether the use of pulse oximetry leads to reduced morbidity and mortality in acute care although there is no robust evidence attesting to its outcome benefits. In contrast, research investigating the outcome effectiveness of tissue oximetry-guided care is consistently ongoing. A recent randomized controlled trial involving 800 patients who underwent laparoscopic hysterectomy found that, although muscular tissue oxygen saturation-guided care did not reduce the overall occurrence of postoperative nausea and vomiting for all patients, it did reduce the occurrence of these symptoms in patients who had a body mass index ≥25. It was also observed that muscular tissue oxygen saturation increases when blood pressure falls following the administration of nicardipine. These studies highlight the persistence of interest in understanding the value of tissue oximetry in patient care.
SUMMARY


Pulse oximetry and tissue oximetry are treated differently although neither monitor has robust evidence attesting to its outcome benefits. This difference may root in the difference in the physiology they monitor, the cost, the ease of use/interpretation/intervention and the relevance to patient safety and care quality. Pulse oxygen saturation represents a vital sign, whereas tissue oxygen saturation is likely a quality sign; however, further research endeavors are required to fully understand how to best use tissue oximetry.",2020,"SUMMARY


Pulse oximetry and tissue oximetry are treated differently although neither monitor has robust evidence attesting to its outcome benefits.","['800 patients who underwent', 'patients who had a body mass index ≥25']","['laparoscopic hysterectomy', 'tissue oximetry-guided care', 'muscular tissue oxygen saturation-guided care', 'nicardipine']","['blood pressure falls', 'overall occurrence of postoperative nausea and vomiting']","[{'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0028005', 'cui_str': 'Nicardipine'}]","[{'cui': 'C0439779', 'cui_str': 'BP fall'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}]",800.0,0.0313832,"SUMMARY


Pulse oximetry and tissue oximetry are treated differently although neither monitor has robust evidence attesting to its outcome benefits.","[{'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Huaping', 'Initials': 'H', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesiology, Jiangxi Cancer Hospital.'}, {'ForeName': 'Junying', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Lingzhong', 'Initials': 'L', 'LastName': 'Meng', 'Affiliation': 'Department of Anesthesiology, Yale University School of Medicine, New Haven, Connecticut, USA.'}]",Current opinion in anaesthesiology,['10.1097/ACO.0000000000000910']
2821,32826635,Blood Flow Restriction Training Blunts Chronic Kidney Disease Progression in Humans.,"PURPOSE


to verify the effect of six months of periodized resistance training (RT) with and without blood flow restriction (BFR) in patients with stage two chronic kidney disease (CKD) on glomerular filtration rate (GFR), uremic parameters, cytokines, and Klotho-fibroblast growth factor 23 (FGF23) axis.
METHODS


105 subjects were randomized in 3 groups of 35 each: control (CTL), RT, and RT+BFR. A first visit was required for an anamnesis to evaluate the number of medications, and anthropometric measurements (body weight, height, and body mass index). Muscle strength (1-RM) was assessed. Venous blood samples were collected at baseline and after six months of training in all patients for the analysis of markers of renal function and integrity, as well as for the determination of the inflammatory profile. Statistical significances were adopted with p < 0.05.
RESULTS


both training therapies attenuated the decline of GFR (p <0.05). The majority of CTL patients declined to stage three CKD (88.5%), whereas fewer incidents were noted with RT (25.7%) and RT+BFR, (17.1%). Improved uremic parameters, as well as inflammation (IL-6; IL-10; IL-15; IL-17a; IL-18; TNF-α) and Klotho-FGF23 axis in RT and RT+BFR (p < 0.05) were observed. Monocyte chemoattractant protein-1 (MCP-1) was not changed (p > 0.05) but presented a large effect size (Cohen's d), demonstrating a propensity for improvement.
CONCLUSION


six months of periodized RT with and without BFR in patients with stage two CKD attenuated the progression of the disease by maintaining GFR, improving uremic parameters, cytokine profile regulation, and Klotho-FGF23 axis.",2020,"Improved uremic parameters, as well as inflammation (IL-6; IL-10; IL-15; IL-17a; IL-18; TNF-α) and Klotho-FGF23 axis in RT and RT+BFR (p < 0.05) were observed.","['patients with stage', 'patients with stage two chronic kidney disease (CKD', 'Humans', '105 subjects were randomized in 3 groups of 35 each']","['periodized resistance training (RT) with and without blood flow restriction (BFR', 'periodized RT with and without BFR', 'Blood Flow Restriction Training', 'control (CTL), RT, and RT+BFR']","['decline of GFR', 'inflammation (IL-6; IL-10; IL-15; IL-17a; IL-18; TNF-α) and Klotho-FGF23 axis in RT and RT+BFR', 'Venous blood samples', 'Improved uremic parameters', 'glomerular filtration rate (GFR), uremic parameters, cytokines, and Klotho-fibroblast growth factor 23 (FGF23) axis', 'Monocyte chemoattractant protein-1', 'progression of the disease by maintaining GFR, improving uremic parameters, cytokine profile regulation, and Klotho-FGF23 axis', 'number of medications, and anthropometric measurements (body weight, height, and body mass index', 'Muscle strength (1-RM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0254610', 'cui_str': 'Interleukin 15'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C1144173', 'cui_str': 'KL protein, human'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",105.0,0.0268884,"Improved uremic parameters, as well as inflammation (IL-6; IL-10; IL-15; IL-17a; IL-18; TNF-α) and Klotho-FGF23 axis in RT and RT+BFR (p < 0.05) were observed.","[{'ForeName': 'Hugo Luca', 'Initials': 'HL', 'LastName': 'Corrêa', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Rodrigo Vanerson Passos', 'Initials': 'RVP', 'LastName': 'Neves', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Lysleine Alves', 'Initials': 'LA', 'LastName': 'Deus', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Michel Kendy', 'Initials': 'MK', 'LastName': 'Souza', 'Affiliation': 'Department of Nephrology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Anderson Sola', 'Initials': 'AS', 'LastName': 'Haro', 'Affiliation': 'Department of Nephrology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Costa', 'Affiliation': 'Department of Nephrology, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Victor Lopes', 'Initials': 'VL', 'LastName': 'Silva', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Claudio Avelino Rodrigues', 'Initials': 'CAR', 'LastName': 'Santos', 'Affiliation': 'Department of Physical Education, Federal University of Tocantins, Tocantins, Brazil.'}, {'ForeName': 'Milton Rocha', 'Initials': 'MR', 'LastName': 'Moraes', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Herbert Gustavo', 'Initials': 'HG', 'LastName': 'Simões', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'James Wilfred', 'Initials': 'JW', 'LastName': 'Navalta', 'Affiliation': 'Kinesiology and Nutrition Sciences, University of Nevada, Las Vegas, NV.'}, {'ForeName': 'Jonato', 'Initials': 'J', 'LastName': 'Prestes', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasilia, Brasilia, Brazil.'}, {'ForeName': 'Thiago Santos', 'Initials': 'TS', 'LastName': 'Rosa', 'Affiliation': 'Graduate Program in Physical Education, Catholic University of Brasilia, Brasilia, Brazil.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002465']
2822,32826695,Effect of Intravenous Infiltration Management Program on Peripheral Intravenous Catheter Success and Infiltration in Hospitalized Infants.,"BACKGROUND


Peripheral intravenous catheter (PIVC) insertion is the most frequently used method for intravenous (IV) treatment in pediatric patients.
PURPOSE


The aim of this study was to determine the effect of the Intravenous Infiltration Management Program on the success of PIVC insertion and infiltration in infants.
METHODS


The study was carried out using a quasi-experimental design with pretest-posttest control groups and included 750 PIVC procedures for 218 infants between 28 days and 12 months of age.
RESULTS


The program decreased the number of PIVC insertions per patient, although it was not statistically significant (P = .076) and had an impact on the success of the PIVC attempt (P < .001), first PIVC attempt (P < .001), PIVC dwell time, and early detection of infiltration (P < .001).
CONCLUSION


The program is effective in the success of the PIVC insertion process and early detection of infiltration.",2020,"The program decreased the number of PIVC insertions per patient, although it was not statistically significant (P = .076) and had an impact on the success of the PIVC attempt (P < .001), first PIVC attempt (P < .001), PIVC dwell time, and early detection of infiltration (P < .001).
","['Hospitalized Infants', '218 infants between 28 days and 12 months of age', 'infants', 'pediatric patients']","['Peripheral intravenous catheter (PIVC) insertion', 'Intravenous Infiltration Management Program']","['PIVC dwell time, and early detection of infiltration', 'Peripheral Intravenous Catheter Success and Infiltration', 'number of PIVC insertions']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0596473', 'cui_str': 'Early Diagnosis'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]",218.0,0.0274586,"The program decreased the number of PIVC insertions per patient, although it was not statistically significant (P = .076) and had an impact on the success of the PIVC attempt (P < .001), first PIVC attempt (P < .001), PIVC dwell time, and early detection of infiltration (P < .001).
","[{'ForeName': 'Yeliz', 'Initials': 'Y', 'LastName': 'Taşdelen', 'Affiliation': 'Department of Pediatric Surgery, Karabük University Education and Research Hospital, Karabük, Turkey (Ms Taşdelen); and Pediatric Nursing Department, Florence Nightingale Faculty of Nursing, İstanbul University-Cerrahpaşa, Istanbul, Turkey (Dr Çağlar).'}, {'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Çağlar', 'Affiliation': ''}]",Journal of nursing care quality,['10.1097/NCQ.0000000000000511']
2823,32826717,"Intervention and Mechanisms of Alanyl-glutamine for Inflammation, Nutrition, and Enteropathy: A Randomized Controlled Trial.","OBJECTIVE


Determine the minimum dosage of alanyl-glutamine (Ala-Gln) required to improve gut integrity and growth in children at risk of environmental enteropathy (EE).
METHODS


This was a double-blinded randomized placebo-controlled dose-response trial. We enrolled 140 children residing in a low-income community in Fortaleza, Brazil. Participants were 2 to 60 months old and had weight-for-age (WAZ), height-for-age (HAZ), or weight-for-height (WHZ) z-scores less than -1. We randomized children to 10 days of nutritional supplementation: Ala-Gln at 3 g/day, Ala-Gln at 6 g/day, Ala-Gln at 12 g/day, or an isonitrogenous dose of glycine (Gly) placebo at 12.5 g/day. Our primary outcome was urinary lactulose-mannitol excretion testing. Secondary outcomes were anthropometry, fecal markers of inflammation, urine metabolic profiles, and malabsorption (spot fecal energy).
RESULTS


Of 140 children, 103 completed 120 days of follow-up (24% dropout). In the group receiving the highest dose of Ala-Gln, we detected a modest improvement in urinary lactulose excretion from 0.19% on day 1 to 0.17% on day 10 (P = 0.05). We observed significant but transient improvements in WHZ at day 10 in 2 Ala-Gln groups, and in WHZ and WAZ in all Ala-Gln groups at day 30. We detected no effects on fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles; but did observe modest reductions in fecal energy and fecal lactoferrin in participants receiving Ala-Gln.
CONCLUSIONS


Intermediate dose Ala-Gln promotes short-term improvement in gut integrity and ponderal growth in children at risk of EE. Lower doses produced improvements in ponderal growth in the absence of enhanced gut integrity.",2020,"We detected no effects on fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles; but did observe modest reductions in fecal energy and fecal lactoferrin in participants receiving Ala-Gln.
CONCLUSIONS


Intermediate dose","['140 children residing in a low-income community in Fortaleza, Brazil', 'children at risk of EE', 'Of 140 children, 103 completed 120 days of follow-up (24% dropout', 'children at risk of environmental enteropathy (EE', 'Participants were 2 to 60 months old and had weight-for-age (WAZ), height-for-age (HAZ), or weight-for-height (WHZ) z-scores less than -1', 'participants receiving Ala-Gln.\nCONCLUSIONS\n\n\nIntermediate dose']","['glycine (Gly) placebo', 'nutritional supplementation: Ala-Gln at 3\u200ag/day, Ala-Gln at 6\u200ag/day, Ala-Gln', 'alanyl-glutamine (Ala-Gln', 'placebo']","['anthropometry, fecal markers of inflammation, urine metabolic profiles, and malabsorption (spot fecal energy', 'gut integrity and ponderal growth', 'fecal energy and fecal lactoferrin', 'Inflammation, Nutrition, and Enteropathy', 'urinary lactulose-mannitol excretion testing', 'urinary lactulose excretion', 'fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0021831', 'cui_str': 'Disorder of intestine'}, {'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0424670', 'cui_str': 'Weight for height'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0051080', 'cui_str': 'alanylglutamine'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0051080', 'cui_str': 'alanylglutamine'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0024523', 'cui_str': 'Malabsorption syndrome'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0022942', 'cui_str': 'Lactoferrin'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0021831', 'cui_str': 'Disorder of intestine'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0024730', 'cui_str': 'Mannitol'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",140.0,0.33091,"We detected no effects on fecal inflammatory markers, diarrheal morbidity, or urine metabolic profiles; but did observe modest reductions in fecal energy and fecal lactoferrin in participants receiving Ala-Gln.
CONCLUSIONS


Intermediate dose","[{'ForeName': 'Sean R', 'Initials': 'SR', 'LastName': 'Moore', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Quinn', 'Affiliation': 'Division of Pediatric Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Maier', 'Affiliation': ""Division of Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Marjorie M', 'Initials': 'MM', 'LastName': 'Guedes', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Josiane S', 'Initials': 'JS', 'LastName': 'Quetz', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Perry', 'Affiliation': ""Division of Gastroenterology, Hepatology, & Nutrition, Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.""}, {'ForeName': 'Chethan', 'Initials': 'C', 'LastName': 'Ramprasad', 'Affiliation': 'Department of Internal Medicine, NYU School of Medicine/NYU Langone Medical Center, New York, NY.'}, {'ForeName': 'Gabriela M L', 'Initials': 'GML', 'LastName': 'Lanzarini Lopes', 'Affiliation': 'Department of Emergency Medicine, Maine Medical Center, Portland, ME.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Mayneris-Perxachs', 'Affiliation': 'Department of Diabetes, Endocrinology and Nutrition, Dr. Josep Trueta University Hospital, and Girona Biomedical Research Institute (IDIBGI), Girona, Spain.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Swann', 'Affiliation': 'Department of Metabolism, Digestion and Reproduction, Imperial College, London.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Soares', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'José Q', 'Initials': 'JQ', 'LastName': 'Filho', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Francisco S', 'Initials': 'FS', 'LastName': 'Junior', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Havt', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Noelia L', 'Initials': 'NL', 'LastName': 'Lima', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Guerrant', 'Affiliation': 'Division of Infectious Disease and International Health, Department of Medicine, Center for Global Health, University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Aldo A M', 'Initials': 'AAM', 'LastName': 'Lima', 'Affiliation': 'Department of Physiology and Pharmacology, Clinical Research Unit & Institute of Biomedicine/Center for Global Health, Faculty of Medicine, Federal University of Ceará, Fortaleza, Ceará, Brazil.'}]",Journal of pediatric gastroenterology and nutrition,['10.1097/MPG.0000000000002834']
2824,32826769,Pooled Efficacy and Safety Profile of Netarsudil Ophthalmic Solution 0.02% in Patients with Open-angle Glaucoma or Ocular Hypertension.,"PRECIS


In pooled Phase III analyses, once-daily netarsudil 0.02% resulted in intraocular pressure reduction that was non-inferior to twice-daily timolol 0.5%, with minimal treatment-related serious or systemic adverse events. Ocular adverse events were generally tolerable.
PURPOSE


To assess the efficacy and safety of the Rho kinase inhibitor netarsudil in patients with open-angle glaucoma or ocular hypertension.
PATIENTS AND METHODS


Pooled analysis of data from the ROCKET-1 to 4 Phase III studies of once-daily (PM) netarsudil or twice-daily timolol in patients with open-angle glaucoma or ocular hypertension. The primary efficacy measure was mean intraocular pressure (IOP) at 8:00 AM, 10:00 AM, and 4:00 PM at Week 2, Week 6, and Month 3 in patients with baseline IOP <25▒mmHg.
RESULTS


In the pooled primary efficacy population (netarsudil, n=494; timolol, n=510), once-daily netarsudil was noninferior to twice-daily timolol at all nine time points through Month 3. Mean treated IOP ranged from 16.4-18.1▒mmHg among netarsudil-treated patients and 16.8-17.6▒mmHg among timolol-treated patients. In the pooled safety population (n=839 in each treatment group), treatment-related serious adverse events occurred at similar frequencies in each treatment group (netarsudil, 0.1%; timolol, 0%). The most common ocular adverse event, conjunctival hyperemia (netarsudil, 54.4%; timolol, 10.4%), was graded as mild in 77.6% (354/456) of affected netarsudil-treated patients.
CONCLUSIONS


Once-daily netarsudil resulted in IOP lowering that was non-inferior to twice-daily timolol, with tolerable ocular adverse events that were generally mild and self-resolving. As a first-in-class agent in the United States, with a novel mechanism of action, netarsudil may provide a useful therapeutic option for patients who would benefit from IOP lowering.",2020,"Once-daily netarsudil resulted in IOP lowering that was non-inferior to twice-daily timolol, with tolerable ocular adverse events that were generally mild and self-resolving.","['Patients with Open-angle Glaucoma or Ocular Hypertension', 'patients who would benefit from IOP lowering', 'patients with open-angle glaucoma or ocular hypertension', 'treated patients']","['timolol', 'daily (PM) netarsudil or twice-daily timolol', 'timolol, n=510), once-daily netarsudil was noninferior to twice-daily timolol', 'Netarsudil Ophthalmic Solution']","['mean intraocular pressure (IOP', 'Ocular adverse events', 'serious or systemic adverse events', 'IOP lowering', 'intraocular pressure reduction', 'Mean treated IOP', 'efficacy and safety', 'serious adverse events', 'ocular adverse event, conjunctival hyperemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0028840', 'cui_str': 'Ocular hypertension'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4535718', 'cui_str': 'netarsudil'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4535721', 'cui_str': 'netarsudil Ophthalmic Solution'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}]",,0.0894801,"Once-daily netarsudil resulted in IOP lowering that was non-inferior to twice-daily timolol, with tolerable ocular adverse events that were generally mild and self-resolving.","[{'ForeName': 'Inder Paul', 'Initials': 'IP', 'LastName': 'Singh', 'Affiliation': 'The Eye Centers of Racine and Kenosha, Racine, WI.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Fechtner', 'Affiliation': 'SUNY Upstate Medical University, Syracuse, NY.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Myers', 'Affiliation': 'Wills Eye Hospital, Philadelphia, PA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Kim', 'Affiliation': 'Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Dale W', 'Initials': 'DW', 'LastName': 'Usner', 'Affiliation': 'Statistics & Data Corporation, Tempe, AZ.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'McKee', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, CA.'}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Sheng', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, CA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Lewis', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, CA.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Heah', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, CA.'}, {'ForeName': 'Casey C', 'Initials': 'CC', 'LastName': 'Kopczynski', 'Affiliation': 'Aerie Pharmaceuticals, Inc., Irvine, CA.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001634']
2825,32821711,Intensity of Statin Treatment in Korean Patients with Acute Myocardial Infarction and Very Low LDL Cholesterol.,"Objective


Data on the intensity of statin therapy for patients with acute myocardial infarction (MI) and very low baseline low-density lipoprotein (LDL) cholesterol level are lacking. We sought to assess the impact of statin intensity in patients with acute MI and LDL cholesterol <70 mg/dL.
Methods


A total of 1,086 patients with acute MI and baseline LDL cholesterol <70 mg/dL from the Korea Acute Myocardial Infarction Registry-National Institute of Health database were divided into less intensive statin (expected LDL reduction <40%, n=302) and more intensive statin (expected LDL reduction ≥40%, n=784) groups. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, MI, revascularization occurring at least 30 days after admission, and stroke, at 12 months.
Results


After 1:2 propensity matching, differences were not observed between less intensive (n=302) and more intensive statin (n=604) groups in incidence of cardiac death (0.3% vs. 0.3%) and hemorrhagic stroke (0.3% vs. 0.5%,  p =0.727) at 12 months. Compared with the less intensive statin group, the more intensive statin group showed lower target-vessel revascularization (4.6% vs. 1.8%,  p =0.027) and MACCE (11.6% vs. 7.0%,  p =0.021). Major bleeding was not different between less intensive and more intensive statin groups (1.0% vs. 2.6%,  p =0.118).
Conclusion


More intensive statin therapy was associated with significantly lower major adverse cardiovascular events in patients with acute MI and very low LDL cholesterol compared with less intensive statin therapy.",2019,"Major bleeding was not different between less intensive and more intensive statin groups (1.0% vs. 2.6%,  p =0.118).
","['Korean Patients with Acute Myocardial Infarction and Very Low LDL Cholesterol', 'patients with acute myocardial infarction (MI) and very low baseline low-density lipoprotein (LDL) cholesterol level are lacking', 'patients with acute MI and LDL cholesterol', 'patients with acute MI', '1,086 patients with acute MI and baseline LDL cholesterol <70 mg/dL from the Korea Acute Myocardial Infarction Registry-National Institute of Health database were divided into less intensive statin (expected LDL reduction <40%, n=302) and more intensive statin (expected LDL reduction ≥40%, n=784) groups']",['statin therapy'],"['hemorrhagic stroke', 'target-vessel revascularization', 'incidence of cardiac death', 'MACCE', 'major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, MI, revascularization occurring at least 30 days after admission, and stroke, at 12 months', 'Major bleeding']","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0442811', 'cui_str': 'Very low'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",1086.0,0.0522134,"Major bleeding was not different between less intensive and more intensive statin groups (1.0% vs. 2.6%,  p =0.118).
","[{'ForeName': 'Doo Sun', 'Initials': 'DS', 'LastName': 'Sim', 'Affiliation': 'Department of Cardiovascular Medicine, Chonnam National University Hospital, Gwangju, Korea.'}, {'ForeName': 'Myung Ho', 'Initials': 'MH', 'LastName': 'Jeong', 'Affiliation': 'Department of Cardiovascular Medicine, Chonnam National University Hospital, Gwangju, Korea.'}, {'ForeName': 'Hyo Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Hyeon Cheol', 'Initials': 'HC', 'LastName': 'Gwon', 'Affiliation': 'Department of Cardiology, Seoul Samsung Medical Center, Sungkyunkwan University, Seoul, Korea.'}, {'ForeName': 'Ki Bae', 'Initials': 'KB', 'LastName': 'Seung', 'Affiliation': 'Department of Cardiology, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Seung Woon', 'Initials': 'SW', 'LastName': 'Rha', 'Affiliation': 'The Cardiovascular Center, Korea University Guro Hospital, Seoul, Korea.'}, {'ForeName': 'Shung Chull', 'Initials': 'SC', 'LastName': 'Chae', 'Affiliation': 'Department of Cardiology, Kyungpook National University Hospital, Daegu, Korea.'}, {'ForeName': 'Chong Jin', 'Initials': 'CJ', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Kyung Hee University Hospital at Gangdong, Seoul, Korea.'}, {'ForeName': 'Kwang Soo', 'Initials': 'KS', 'LastName': 'Cha', 'Affiliation': 'Department of Cardiology, Pusan National University Hospital, Busan, Korea.'}, {'ForeName': 'Jong Seon', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Yeungnam University Hospital, Daegu, Korea.'}, {'ForeName': 'Jung Han', 'Initials': 'JH', 'LastName': 'Yoon', 'Affiliation': 'Division of Cardiology, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital, Wonju, Korea.'}, {'ForeName': 'Jei Keon', 'Initials': 'JK', 'LastName': 'Chae', 'Affiliation': 'Department of Cardiology, Chunbuk National University Hospital, Jeonju, Korea.'}, {'ForeName': 'Seung Jae', 'Initials': 'SJ', 'LastName': 'Joo', 'Affiliation': 'Department of Cardiology, Jeju National University Hospital, Jeju, Korea.'}, {'ForeName': 'Dong Ju', 'Initials': 'DJ', 'LastName': 'Choi', 'Affiliation': 'Department of Cardiology, Seoul National University Bundang Hospital, Seongnam, Korea.'}, {'ForeName': 'Seung Ho', 'Initials': 'SH', 'LastName': 'Hur', 'Affiliation': 'Division of Cardiology, Keimyung University Dongsan Medical Center, Daegu, Korea.'}, {'ForeName': 'In Whan', 'Initials': 'IW', 'LastName': 'Seong', 'Affiliation': 'Department of Cardiology, Chungnam National University Hospital, Daejeon, Korea.'}, {'ForeName': 'Myeong Chan', 'Initials': 'MC', 'LastName': 'Cho', 'Affiliation': 'Department of Cardiology, Chungbuk National University Hospital, Cheongju, Korea.'}, {'ForeName': 'Doo Il', 'Initials': 'DI', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Inje University Haeundae Paik Hospital, Busan, Korea.'}, {'ForeName': 'Seok Kyu', 'Initials': 'SK', 'LastName': 'Oh', 'Affiliation': 'Department of Cardiology, Wonkwang University Hospital, Iksan, Korea.'}, {'ForeName': 'Tae Hoon', 'Initials': 'TH', 'LastName': 'Ahn', 'Affiliation': 'Department of Cardiology, Gachon University Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Jin Yong', 'Initials': 'JY', 'LastName': 'Hwang', 'Affiliation': 'Division of Cardiology, Gyungsang National University Hospital, Jinju, Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of lipid and atherosclerosis,['10.12997/jla.2019.8.2.208']
2826,32821712,Efficacy and Safety of Prescription Omega-3 Fatty Acids Added to Stable Statin Therapy in Korean Patients with Type 2 Diabetes and Hypertriglyceridemia: a Randomized Controlled Trial.,"Objective


The aim of this study was to investigate the effects of omega-3 fatty acids added to statin monotherapy in Korean patients with type 2 diabetes who have persistent hypertriglyceridemia despite statin therapy.
Methods


This study was a randomized controlled trial conducted in 4 clinical sites between February 2009 and February 2011. The inclusion criteria were patients with type 2 diabetes who had received ≥6 weeks of statin therapy and had fasting triglyceride (TG) levels ≥1.7mmol/L and low-density lipoprotein (LDL) cholesterol levels <2.6 mmol/L. The study regimen consisted of 16 weeks of randomized treatment with omega-3 fatty acids (4 g/day) plus a statin (n=26) or statin only (n=30). The primary endpoint was the change from baseline to final visit in mean TG level.
Results


A total of 56 participants were analyzed. At week 16, the change in the TG level in the combination therapy group differed significantly from the change in the statin monotherapy group (-34.8% vs. -15.2%,  p =0.0176). Treatment with omega-3 fatty acids plus a statin was also associated with a significant decrease in non-high-density lipoprotein cholesterol compared with baseline, but the difference was not significant compared with the statin monotherapy group (-8.0% vs. -2.5%,  p =0.165). The changes in LDL cholesterol and HbA1c levels did not differ significantly between groups. The study medications were well tolerated, and adverse events were comparable between two groups.
Conclusion


Adding omega-3 fatty acids to statin treatment reduced TG levels more effectively than statin monotherapy without undesirable effects in Korean type 2 diabetic patients who had hypertriglyceridemia despite well-controlled LDL cholesterol on stable statin therapy.
Trial Registration


ClinicalTrials.gov Identifier: NCT02305355.",2019,The changes in LDL cholesterol and HbA1c levels did not differ significantly between groups.,"['patients with type 2 diabetes who had received ≥6 weeks of statin therapy and had', 'Korean type 2 diabetic patients who had hypertriglyceridemia despite well-controlled LDL cholesterol on stable statin therapy', 'Korean Patients with Type 2 Diabetes and Hypertriglyceridemia', 'Korean patients with type 2 diabetes who have persistent hypertriglyceridemia despite statin therapy', '4 clinical sites between February 2009 and February 2011', 'A total of 56 participants were analyzed']","['omega-3 fatty acids', 'Prescription Omega-3 Fatty Acids Added to Stable Statin Therapy', 'statin (n=26) or statin', 'statin monotherapy']","['LDL cholesterol and HbA1c levels', 'non-high-density lipoprotein cholesterol', 'TG level', 'change from baseline to final visit in mean TG level', 'fasting triglyceride (TG) levels ≥1.7mmol/L and low-density lipoprotein (LDL) cholesterol levels', 'tolerated, and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",56.0,0.103999,The changes in LDL cholesterol and HbA1c levels did not differ significantly between groups.,"[{'ForeName': 'Jang Won', 'Initials': 'JW', 'LastName': 'Son', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, The Catholic University of Korea, Bucheon St. Mary's Hospital, Bucheon, Korea.""}, {'ForeName': 'Chul-Hee', 'Initials': 'CH', 'LastName': 'Kim', 'Affiliation': 'Division of Endocrinology & Metabolism, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.'}, {'ForeName': 'Mun Suk', 'Initials': 'MS', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea.'}, {'ForeName': 'Ie Byung', 'Initials': 'IB', 'LastName': 'Park', 'Affiliation': 'Department of Endocrinology, Gachon University of Medicine and Science, Gil Medical Center, Incheon, Korea.'}, {'ForeName': 'Soon Jib', 'Initials': 'SJ', 'LastName': 'Yoo', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, The Catholic University of Korea, Bucheon St. Mary's Hospital, Bucheon, Korea.""}]",Journal of lipid and atherosclerosis,['10.12997/jla.2019.8.2.221']
2827,32821729,Efficacy and Safety of High-Dose Atorvastatin in Moderate-to-High Cardiovascular Risk Postmenopausal Korean Women with Dyslipidemia.,"Objective


Postmenopausal women show a more atherogenic lipid profile and elevated cardiovascular risk compared to premenopausal women. The aim of this study was to investigate the efficacy and safety of high-dose atorvastatin on the improvement of the blood lipid profile of postmenopausal women in Korea.
Methods


This study is a prospective, open-label, single-arm clinical trial that was conducted in 3 teaching hospitals. Postmenopausal women with a moderate-to-high cardiovascular risk, according to guidelines from the Korean Society of Lipid & Atherosclerosis, were enrolled. Participants were administered 20 mg of atorvastatin daily for the first 8 weeks, and if the targeted low-density lipoprotein cholesterol (LDL-C) level was not achieved, the dose was increased to 40 mg for the second 8 weeks. The primary endpoint was percentage change of LDL-C from baseline after 16 weeks of drug administration.
Results


Forty-four women were enrolled, 28 of whom (75.6%) had diabetes mellitus. By the end of treatment period (16 weeks) all patients had achieved LDL-C target levels, with 33 (94.2%) of the participants achieving it after only 8 weeks of administration. After 16 weeks, LDL-C decreased by 45.8±16.7% ( p <0.001) from the baseline, and total cholesterol (33.2±10.9%;  p <0.001), triglyceride (24.2±37.5%;  p =0.001), and apolipoprotein B (34.9±15.6%;  p <0.001) also significantly decreased. Blood glucose and liver enzyme levels slightly increased, but none of the participants developed serious adverse events that would cause them to prematurely withdraw from the clinical trial.
Conclusion


20 and 40 mg atorvastatin was effective and safe for treating dyslipidemia in postmenopausal Korean women with moderate-to-high cardiovascular risk.",2020,"After 16 weeks, LDL-C decreased by 45.8±16.7% ( p <0.001) from the baseline, and total cholesterol (33.2±10.9%;  p <0.001), triglyceride (24.2±37.5%;  p =0.001), and apolipoprotein B (34.9±15.6%;  p <0.001) also significantly decreased.","['3 teaching hospitals', 'postmenopausal women in Korea', 'postmenopausal Korean women with moderate-to-high cardiovascular risk', 'Moderate-to-High Cardiovascular Risk Postmenopausal Korean Women with Dyslipidemia', 'Results\n\n\nForty-four women were enrolled, 28 of whom (75.6%) had diabetes mellitus', 'Postmenopausal women with a moderate-to-high cardiovascular risk, according to guidelines from the Korean Society of Lipid & Atherosclerosis, were enrolled', 'premenopausal women']","['atorvastatin', 'High-Dose Atorvastatin']","['Efficacy and Safety', 'percentage change of LDL-C', 'blood lipid profile', 'total cholesterol', 'atherogenic lipid profile and elevated cardiovascular risk', 'apolipoprotein B', 'LDL-C target levels', 'efficacy and safety', 'serious adverse events', 'triglyceride', 'density lipoprotein cholesterol (LDL-C) level', 'LDL-C', 'Blood glucose and liver enzyme levels']","[{'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}]",44.0,0.0767014,"After 16 weeks, LDL-C decreased by 45.8±16.7% ( p <0.001) from the baseline, and total cholesterol (33.2±10.9%;  p <0.001), triglyceride (24.2±37.5%;  p =0.001), and apolipoprotein B (34.9±15.6%;  p <0.001) also significantly decreased.","[{'ForeName': 'Jaecheol', 'Initials': 'J', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Jeju National University Hospital, Jeju, Korea.'}, {'ForeName': 'Soyeon', 'Initials': 'S', 'LastName': 'Yoo', 'Affiliation': 'Department of Internal Medicine, Jeju National University Hospital, Jeju, Korea.'}, {'ForeName': 'Gwanpyo', 'Initials': 'G', 'LastName': 'Koh', 'Affiliation': 'Department of Internal Medicine, Jeju National University Hospital, Jeju, Korea.'}, {'ForeName': 'Kyung-Wan', 'Initials': 'KW', 'LastName': 'Min', 'Affiliation': 'Department of Internal Medicine, Eulji Hospital, Seoul, Korea.'}, {'ForeName': 'Hyun Ho', 'Initials': 'HH', 'LastName': 'Shin', 'Affiliation': 'Department of Medicine/Cardiology, Cheil General Hospital, Seoul, Korea.'}]",Journal of lipid and atherosclerosis,['10.12997/jla.2020.9.1.162']
2828,32821737,Lipid-Lowering Efficacy and Safety of a New Generic Rosuvastatin in Koreans: an 8-Week Randomized Comparative Study with a Proprietary Rosuvastatin.,"Objective


The aim of this study was to investigate whether a new generic rosuvastatin is non-inferior to a proprietary one in terms of lipid-lowering efficacy. We also evaluated its non-lipid effects including adverse events.
Methods


One-hundred and fifty-eight patients with cardiovascular risks requiring pharmacological lipid-lowering therapy were screened. After a 4-week run-in period, 126 individuals who met the lipid criteria for drug therapy were randomly assigned to receive the new generic or proprietary rosuvastatin 10 mg daily for 8 weeks. The primary outcome variables were low-density lipoprotein-cholesterol (LDL-C) reduction and LDL-C target achievement. Hematological and biochemical parameters and adverse events were assessed.
Results


After 8 weeks of drug treatment, the mean percentage change in LDL-C was not different between the groups (-45.5%±19.9% and -45.1%±19.0% for generic and proprietary rosuvastatin, respectively;  p =0.38). The LDL-C target achievement rate was similar between the groups (75.0% and 77.1% for generic and proprietary rosuvastatin, respectively;  p =0.79). The percentage change in the other lipid profiles was not significantly different. Although generic- and proprietary rosuvastatins modestly affected creatine kinase and blood pressure, respectively, the changes were all within normal ranges. Incidence of adverse events did not differ between the receivers of the 2 formulations.
Conclusion


The new generic rosuvastatin was non-inferior to the proprietary rosuvastatin in terms of lipid-lowering efficacy. The rosuvastatin formulations did not exhibit clinically significant non-lipid effects with good safety profiles. Our study provides comprehensive data regarding 2 rosuvastatin formulations in East Asian subjects.
Trial Registration


ClinicalTrials.gov Identifier: NCT03949374.",2020,"Incidence of adverse events did not differ between the receivers of the 2 formulations.
","['East Asian subjects', 'Koreans', '126 individuals who met the lipid criteria for drug therapy', 'Methods\n\n\nOne-hundred and fifty-eight patients with cardiovascular risks requiring pharmacological lipid-lowering therapy were screened']","['new generic or proprietary rosuvastatin', 'rosuvastatin', 'New Generic Rosuvastatin', 'Proprietary Rosuvastatin']","['low-density lipoprotein-cholesterol (LDL-C) reduction and LDL-C target achievement', 'LDL-C target achievement rate', 'creatine kinase and blood pressure', 'Hematological and biochemical parameters and adverse events', 'Incidence of adverse events', 'mean percentage change in LDL-C']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",158.0,0.0482785,"Incidence of adverse events did not differ between the receivers of the 2 formulations.
","[{'ForeName': 'Hyoeun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Health Promotion, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Chan Joo', 'Initials': 'CJ', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'In-Cheol', 'Initials': 'IC', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Dongsan Medical Center, Keimyung University College of Medicine, Daegu, Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Ewha Womans University Seoul Hospital, Seoul, Korea.'}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Geu-Ru', 'Initials': 'GR', 'LastName': 'Hong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'In-Jeong', 'Initials': 'IJ', 'LastName': 'Cho', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Ewha Womans University Seoul Hospital, Seoul, Korea.'}, {'ForeName': 'Chi-Young', 'Initials': 'CY', 'LastName': 'Shim', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Sang-Hak', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.'}]",Journal of lipid and atherosclerosis,['10.12997/jla.2020.9.2.283']
2829,32821745,The Effect of Nano-Curcumin Supplementation on Pentraxin 3 Gene Expression and Serum Level in Migraine Patients.,"Background


This study was designed to investigate the effect of nano-curcumin supplementation on pentraxin 3 (PTX3) gene exp ression and serum level in migraine patients.
Methods


The present study, performed as a clinical trial, included 38 episodic migraine patients in two groups that received either nano-curcumin or placebo over a two-month period. At the start and the end of the study, PTX3 gene expression and serum levels were measured.
Results


After two months of treatment, PTX3 gene expression and serum levels were both significantly less in the nano-curcumin than in the placebo group (P= 0.01 and P< 0.001, respectively). No significant gene expression differences were found between the two groups.
Conclusion


Curcumin may have a potential inhibitory effect on PTX3 gene expression and serum levels in migraine disease and can be considered as an efficient therapy in migraine management.",2020,"After two months of treatment, PTX3 gene expression and serum levels were both significantly less in the nano-curcumin than in the placebo group (P= 0.01 and P< 0.001, respectively).","['Migraine Patients', '38 episodic migraine patients in two groups that received either', 'migraine patients']","['placebo', 'Nano-Curcumin Supplementation', 'nano-curcumin or placebo', 'nano-curcumin supplementation']","['PTX3 gene expression and serum levels', 'pentraxin 3 (PTX3) gene exp ression and serum level', 'Pentraxin 3 Gene Expression and Serum Level']","[{'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0174234', 'cui_str': 'PTX3 protein'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]",38.0,0.043574,"After two months of treatment, PTX3 gene expression and serum levels were both significantly less in the nano-curcumin than in the placebo group (P= 0.01 and P< 0.001, respectively).","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Djalali', 'Affiliation': 'Department of Medical Microbiology, Faculty of Medicine, Shahed University, Tehran, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Djalali', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Abdolahi', 'Affiliation': 'Department of Cellular and Molecular Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Mohammadi', 'Affiliation': 'Student Research Committee, Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hajar', 'Initials': 'H', 'LastName': 'Heidari', 'Affiliation': 'Student Research Committee, Department of Clinical Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Hosseini', 'Affiliation': 'Faculty of Basic Sciences, Tehran Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Sadeghizadeh', 'Affiliation': 'Department of Medical Microbiology, Faculty of Medicine, Shahed University, Tehran, Iran.'}]",Reports of biochemistry & molecular biology,['10.29252/rbmb.9.1.1']
2830,32821805,"A Resident-Authored, Case-Based Electrocardiogram Email Curriculum for Internal Medicine Residents.","Introduction


The interpretation of electrocardiograms (ECGs) is a critical competency for internal medicine trainees, yet time and resources to foster proficiency are limited.
Methods


This resident-authored ECG email curriculum for first-year residents involved 129 first-year internal medicine residents at three major academic university hospitals. Residents either received the resident-authored ECG email curriculum (intervention group) or continued standard training (control group). The curriculum involved 10 multiple-choice ECG cases emailed biweekly over the 6-month study period. All participants were asked to complete a pre- and postintervention test to assess ECG interpretation competency and attitudes. The primary outcome was improvement in ECG test performance.
Results


Among the 129 first-year residents participating, 21 of the 65 (32%) randomized to the intervention group and 13 of the 64 (20%) randomized to the control group completed both the pre- and posttests for analysis. While all participants' ECG test scores improved over the study period ( p  < .001), improvement did not differ between groups ( p  = .860). We found that the effect of the intervention on ECG test performance varied significantly by the number of cardiology rotations an intern experienced ( p  = .031), benefiting naïve learners the most. All intervention group participants who completed the posttest reported they would recommend it to a colleague.
Discussion


While it did not improve resident performance on an ECG posttest, this resident-authored ECG email curriculum offers a scalable way to provide trainees additional practice with ECG interpretation, with particular benefit to trainees who have not yet rotated on cardiology.",2020,"Discussion


While it did not improve resident performance on an ECG posttest","['Among the 129 first-year residents participating, 21 of the 65 (32', 'first-year residents involved 129 first-year internal medicine residents at three major academic university hospitals']",['resident-authored ECG email curriculum (intervention group) or continued standard training (control group'],"['ECG posttest', 'ECG test scores', 'ECG test performance']","[{'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",129.0,0.0405118,"Discussion


While it did not improve resident performance on an ECG posttest","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Klein', 'Affiliation': 'Clinical Instructor, Division of General Internal Medicine, University of Pittsburgh School of Medicine.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Berlacher', 'Affiliation': 'Fellow, Department of Cardiology, University of Texas Southwestern Medical Center.'}, {'ForeName': 'Jesse A', 'Initials': 'JA', 'LastName': 'Doran', 'Affiliation': 'Fellow, Division of Cardiology, University of Rochester Medical Center.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Corbelli', 'Affiliation': 'Associate Professor of Medicine, Division of General Internal Medicine, University of Pittsburgh School of Medicine.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Rothenberger', 'Affiliation': 'Assistant Professor of Medicine, Division of General Internal Medicine, University of Pittsburgh School of Medicine.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Berlacher', 'Affiliation': 'Assistant Professor of Medicine, Heart and Vascular Institute, University of Pittsburgh School of Medicine.'}]",MedEdPORTAL : the journal of teaching and learning resources,['10.15766/mep_2374-8265.10927']
2831,32821924,Association of Sex or Race With the Effect of Weight Loss on Physical Function: A Secondary Analysis of 8 Randomized Clinical Trials.,"Importance


Consideration of differential treatment effects among subgroups in clinical trial research is a topic of increasing interest. This is an especially salient issue for weight loss trials.
Objective


To determine whether stratification by sex and race is associated with meaningful differences in physical function response to weight loss among older adults.
Design, Setting, and Participants


This pooled analysis used individual-level data from 8 completed randomized clinical trials of weight loss conducted at Wake Forest University or Wake Forest School of Medicine, Winston-Salem, North Carolina. Data were housed within the Wake Forest Older Americans Independence Center data repository and provided complete exposure, outcome, and covariate information. Data were collected from November 1996 to March 30, 2017, and analyzed from August 15, 2019, to June 10, 2020.
Exposures


Treatment arms within each study were collapsed into caloric restriction (CR [n = 734]) and non-CR (n = 583) categories based on whether caloric restriction was specified in the original study protocol.
Main Outcomes and Measures


Objectively measured 6-month change in weight, fast-paced gait speed (meters per second), and Short Physical Performance Battery (SPPB) score.
Results


A total of 1317 adults (mean [SD] age, 67.7 [5.4] years; 920 [69.9%] female; 275 [20.9%] Black) with overweight or obesity (mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 33.9 [4.4]) were included at baseline. Six-month weight change achieved among those randomized to CR was -7.7% (95% CI, -8.3% to -7.2%), with no difference noted by sex; however, White individuals lost more weight than Black individuals assigned to CR (-9.0% [95% CI, -9.6% to -8.4%] vs -6.0% [95% CI, -6.9% to 5.2%]; P < .001), and all CR groups lost a significantly greater amount from baseline compared with non-CR groups (Black participants in CR vs non-CR groups, -5.3% [95% CI, -6.4% to -4.1%; P < .001]; White participants in CR vs non-CR groups, -7.2% [95% CI, -7.8% to -6.6%; P < .001]). Women experienced greater weight loss-associated improvement in SPPB score (CR group, 0.35 [95% CI, 0.18-0.52]; non-CR group, 0.08 [95% CI, -0.11 to 0.27]) compared with men (CR group, 0.23 [95% CI, 0.00-0.46]; non-CR group, 0.34 [95% CI, 0.09-0.58]; P = .03). Black participants experienced greater weight loss-associated improvement in gait speed (CR group, 0.08 [95% CI, 0.05-0.10] m/s; non-CR group, 0.02 [95% CI, -0.01 to 0.05] m/s) compared with White participants (CR group, 0.07 [95% CI, 0.06-0.09] m/s; non-CR group, 0.06 [95% CI, 0.04-0.08] m/s; P = .02).
Conclusions and Relevance


The association of weight loss on physical function in older adults appears to differ by sex and race. These findings affirm the need to consider biological variables in clinical trial design.",2020,"Black participants experienced greater weight loss-associated improvement in gait speed (CR group, 0.08 [95% CI, 0.05-0.10] m/s;","['older adults', 'weight loss conducted at Wake Forest University or Wake Forest School of Medicine, Winston-Salem, North Carolina', 'A total of 1317 adults (mean [SD] age, 67.7\u2009[5.4] years; 920', '69.9%] female; 275 [20.9%] Black) with overweight or obesity (mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 33.9\u2009[4.4]) were included at baseline', 'Data were collected from November 1996 to March 30, 2017, and analyzed from August 15, 2019, to June 10, 2020']",[],"['Main Outcomes and Measures\n\n\nObjectively measured 6-month change in weight, fast-paced gait speed (meters per second), and Short Physical Performance Battery (SPPB) score', 'SPPB score', 'weight loss', 'Physical Function', 'weight loss-associated improvement in gait speed']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0086312', 'cui_str': 'Forest'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517676', 'cui_str': '275'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C4517718', 'cui_str': '33.9'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]",[],"[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",1317.0,0.165494,"Black participants experienced greater weight loss-associated improvement in gait speed (CR group, 0.08 [95% CI, 0.05-0.10] m/s;","[{'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Beavers', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Rebecca H', 'Initials': 'RH', 'LastName': 'Neiberg', 'Affiliation': 'Department of Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Kritchevsky', 'Affiliation': 'Sections of Gerontology and Cardiovascular Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Nicklas', 'Affiliation': 'Sections of Gerontology and Cardiovascular Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Dalane W', 'Initials': 'DW', 'LastName': 'Kitzman', 'Affiliation': 'Sections of Gerontology and Cardiovascular Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Messier', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'W Jack', 'Initials': 'WJ', 'LastName': 'Rejeski', 'Affiliation': 'Department of Health and Exercise Science, Wake Forest University, Winston-Salem, North Carolina.'}, {'ForeName': 'Jamy D', 'Initials': 'JD', 'LastName': 'Ard', 'Affiliation': 'Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Beavers', 'Affiliation': 'Department of Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.14631']
2832,32821939,Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19: A Randomized Clinical Trial.,"Importance


Remdesivir demonstrated clinical benefit in a placebo-controlled trial in patients with severe coronavirus disease 2019 (COVID-19), but its effect in patients with moderate disease is unknown.
Objective


To determine the efficacy of 5 or 10 days of remdesivir treatment compared with standard care on clinical status on day 11 after initiation of treatment.
Design, Setting, and Participants


Randomized, open-label trial of hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (pulmonary infiltrates and room-air oxygen saturation >94%) enrolled from March 15 through April 18, 2020, at 105 hospitals in the United States, Europe, and Asia. The date of final follow-up was May 20, 2020.
Interventions


Patients were randomized in a 1:1:1 ratio to receive a 10-day course of remdesivir (n = 197), a 5-day course of remdesivir (n = 199), or standard care (n = 200). Remdesivir was dosed intravenously at 200 mg on day 1 followed by 100 mg/d.
Main Outcomes and Measures


The primary end point was clinical status on day 11 on a 7-point ordinal scale ranging from death (category 1) to discharged (category 7). Differences between remdesivir treatment groups and standard care were calculated using proportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicates difference in clinical status distribution toward category 7 for the remdesivir group vs the standard care group.
Results


Among 596 patients who were randomized, 584 began the study and received remdesivir or continued standard care (median age, 57 [interquartile range, 46-66] years; 227 [39%] women; 56% had cardiovascular disease, 42% hypertension, and 40% diabetes), and 533 (91%) completed the trial. Median length of treatment was 5 days for patients in the 5-day remdesivir group and 6 days for patients in the 10-day remdesivir group. On day 11, patients in the 5-day remdesivir group had statistically significantly higher odds of a better clinical status distribution than those receiving standard care (odds ratio, 1.65; 95% CI, 1.09-2.48; P = .02). The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test). By day 28, 9 patients had died: 2 (1%) in the 5-day remdesivir group, 3 (2%) in the 10-day remdesivir group, and 4 (2%) in the standard care group. Nausea (10% vs 3%), hypokalemia (6% vs 2%), and headache (5% vs 3%) were more frequent among remdesivir-treated patients compared with standard care.
Conclusions and Relevance


Among patients with moderate COVID-19, those randomized to a 10-day course of remdesivir did not have a statistically significant difference in clinical status compared with standard care at 11 days after initiation of treatment. Patients randomized to a 5-day course of remdesivir had a statistically significant difference in clinical status compared with standard care, but the difference was of uncertain clinical importance.
Trial Registration


ClinicalTrials.gov Identifier: NCT04292730.",2020,The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test).,"['patients with moderate COVID-19', '94%) enrolled from March 15 through April 18, 2020, at 105 hospitals in the United States, Europe, and Asia', '596 patients who were randomized', 'Patients With Moderate COVID-19', 'hospitalized patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and moderate COVID-19 pneumonia (pulmonary infiltrates and room-air oxygen saturation', 'patients with severe coronavirus disease 2019 (COVID-19', ' 584 began the study and received remdesivir or continued standard care (median age, 57 [interquartile range, 46-66] years; 227 [39%] women; 56% had cardiovascular disease, 42% hypertension, and 40% diabetes), and 533 (91%) completed the trial']","['Remdesivir vs Standard Care', 'remdesivir treatment', 'placebo']","['headache', 'Nausea', 'clinical status on day 11 on a 7-point ordinal scale ranging from death (category 1) to discharged (category 7', 'hypokalemia', 'clinical status distribution', 'Median length of treatment', 'clinical status']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0003980', 'cui_str': 'Asia'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0235896', 'cui_str': 'Lung infiltration'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4726677', 'cui_str': 'remdesivir'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0020621', 'cui_str': 'Hypokalemia'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.105766,The clinical status distribution on day 11 between the 10-day remdesivir and standard care groups was not significantly different (P = .18 by Wilcoxon rank sum test).,"[{'ForeName': 'Christoph D', 'Initials': 'CD', 'LastName': 'Spinner', 'Affiliation': 'Technical University of Munich, School of Medicine, University Hospital Rechts der Isar, Munich, Germany.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Gottlieb', 'Affiliation': 'Baylor University Medical Center, Dallas, Texas.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Arribas López', 'Affiliation': 'Instituto de Investigación Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Cattelan', 'Affiliation': 'Azienda Ospedaliera di Padova, Padova, Italy.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Soriano Viladomiu', 'Affiliation': 'Hospital Clinic of Barcelona, IDIBAPS, Barcelona, Spain.'}, {'ForeName': 'Onyema', 'Initials': 'O', 'LastName': 'Ogbuagu', 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Prashant', 'Initials': 'P', 'LastName': 'Malhotra', 'Affiliation': 'North Shore University Hospital, Manhasset, New York.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mullane', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Castagna', 'Affiliation': 'IRCCS San Raffaele Hospital and Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Louis Yi Ann', 'Initials': 'LYA', 'LastName': 'Chai', 'Affiliation': 'National University Health System, Singapore.'}, {'ForeName': 'Meta', 'Initials': 'M', 'LastName': 'Roestenberg', 'Affiliation': 'Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Owen Tak Yin', 'Initials': 'OTY', 'LastName': 'Tsang', 'Affiliation': 'Princess Margaret Hospital, Hong Kong, China.'}, {'ForeName': 'Enos', 'Initials': 'E', 'LastName': 'Bernasconi', 'Affiliation': 'Ente Ospedaliero Cantonale, Bellinzona, Switzerland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Le Turnier', 'Affiliation': 'University of Nantes, Nantes, France.'}, {'ForeName': 'Shan-Chwen', 'Initials': 'SC', 'LastName': 'Chang', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Devi', 'Initials': 'D', 'LastName': 'SenGupta', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Hyland', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Anu O', 'Initials': 'AO', 'LastName': 'Osinusi', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Huyen', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Blair', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Hongyuan', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Gaggar', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Brainard', 'Affiliation': 'Gilead Sciences, Foster City, California.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'McPhail', 'Affiliation': ""King's College, London, England.""}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Bhagani', 'Affiliation': 'Royal Free Hospital, London, England.'}, {'ForeName': 'Mi Young', 'Initials': 'MY', 'LastName': 'Ahn', 'Affiliation': 'Seoul Medical Center, Seoul, South Korea.'}, {'ForeName': 'Arun J', 'Initials': 'AJ', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University, Richmond.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Huhn', 'Affiliation': 'Cook County Health, Chicago, Illinois.'}, {'ForeName': 'Francisco M', 'Initials': 'FM', 'LastName': 'Marty', 'Affiliation': ""Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.16349']
2833,32821954,[Randomized controlled trial for palliative radiotherapy of head and neck cancer-challenges remain].,,2020,,[],['palliative radiotherapy'],[],[],"[{'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]",[],,0.116873,,"[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fabian', 'Affiliation': 'Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel, Arnold-Heller-Str.\xa03, 24105, Kiel, Deutschland. alexander.fabian@uksh.de.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel, Arnold-Heller-Str.\xa03, 24105, Kiel, Deutschland.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Dunst', 'Affiliation': 'Klinik für Strahlentherapie, Universitätsklinikum Schleswig-Holstein (UKSH), Campus Kiel, Arnold-Heller-Str.\xa03, 24105, Kiel, Deutschland.'}]",Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al],['10.1007/s00066-020-01672-2']
2834,32731878,Artificial neural networks improve early outcome prediction and risk classification in out-of-hospital cardiac arrest patients admitted to intensive care.,"BACKGROUND


Pre-hospital circumstances, cardiac arrest characteristics, comorbidities and clinical status on admission are strongly associated with outcome after out-of-hospital cardiac arrest (OHCA). Early prediction of outcome may inform prognosis, tailor therapy and help in interpreting the intervention effect in heterogenous clinical trials. This study aimed to create a model for early prediction of outcome by artificial neural networks (ANN) and use this model to investigate intervention effects on classes of illness severity in cardiac arrest patients treated with targeted temperature management (TTM).
METHODS


Using the cohort of the TTM trial, we performed a post hoc analysis of 932 unconscious patients from 36 centres with OHCA of a presumed cardiac cause. The patient outcome was the functional outcome, including survival at 180 days follow-up using a dichotomised Cerebral Performance Category (CPC) scale with good functional outcome defined as CPC 1-2 and poor functional outcome defined as CPC 3-5. Outcome prediction and severity class assignment were performed using a supervised machine learning model based on ANN.
RESULTS


The outcome was predicted with an area under the receiver operating characteristic curve (AUC) of 0.891 using 54 clinical variables available on admission to hospital, categorised as background, pre-hospital and admission data. Corresponding models using background, pre-hospital or admission variables separately had inferior prediction performance. When comparing the ANN model with a logistic regression-based model on the same cohort, the ANN model performed significantly better (p = 0.029). A simplified ANN model showed promising performance with an AUC above 0.852 when using three variables only: age, time to ROSC and first monitored rhythm. The ANN-stratified analyses showed similar intervention effect of TTM to 33 °C or 36 °C in predefined classes with different risk of a poor outcome.
CONCLUSION


A supervised machine learning model using ANN predicted neurological recovery, including survival excellently, and outperformed a conventional model based on logistic regression. Among the data available at the time of hospitalisation, factors related to the pre-hospital setting carried most information. ANN may be used to stratify a heterogenous trial population in risk classes and help determine intervention effects across subgroups.",2020,"A supervised machine learning model using ANN predicted neurological recovery, including survival excellently, and outperformed a conventional model based on logistic regression.","['out-of-hospital cardiac arrest patients admitted to intensive care', 'cardiac arrest patients treated with targeted temperature management (TTM', '932 unconscious patients from 36 centres with OHCA of a presumed cardiac cause']","['artificial neural networks (ANN', 'TTM', 'Artificial neural networks']","['functional outcome, including survival at 180\xa0days follow-up using a dichotomised Cerebral Performance Category (CPC) scale with good functional outcome defined as CPC 1-2 and poor functional outcome', 'admission to hospital, categorised as background, pre-hospital and admission data', 'area under the receiver operating characteristic curve (AUC']","[{'cui': 'C2936490', 'cui_str': 'Out-of-Hospital Heart Arrest'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0041654', 'cui_str': 'Unconscious (Psychology)'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",932.0,0.0410974,"A supervised machine learning model using ANN predicted neurological recovery, including survival excellently, and outperformed a conventional model based on logistic regression.","[{'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Johnsson', 'Affiliation': 'Department of Clinical Sciences Lund, Anesthesia & Intensive Care, Helsingborg Hospital, Lund University, Helsingborg, Sweden. jesper.johnsson@skane.se.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Björnsson', 'Affiliation': 'Centre for Mathematical Sciences, Mathematical Statistics, Lund University, Lund, Sweden.'}, {'ForeName': 'Peder', 'Initials': 'P', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Sciences Lund, Anesthesia & Intensive Care, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Jakobsson', 'Affiliation': 'Centre for Mathematical Sciences, Mathematical Statistics, Lund University, Lund, Sweden.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Cronberg', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Lilja', 'Affiliation': 'Department of Clinical Sciences Lund, Neurology, Skåne University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Friberg', 'Affiliation': 'Department of Clinical Sciences Lund, Intensive and Perioperative Care, Skåne University Hospital, Lund University, Malmö, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Cardiology, The Heart Centre, Rigshospitalet University Hospital and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kjaergard', 'Affiliation': 'Department of Cardiology, The Heart Centre, Rigshospitalet University Hospital and Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Wise', 'Affiliation': 'Department of Critical Care, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Department of Clinical Sciences Lund, Anesthesia & Intensive Care, Helsingborg Hospital, Lund University, Helsingborg, Sweden.'}, {'ForeName': 'Attila', 'Initials': 'A', 'LastName': 'Frigyesi', 'Affiliation': 'Centre for Mathematical Sciences, Mathematical Statistics, Lund University, Lund, Sweden.'}]","Critical care (London, England)",['10.1186/s13054-020-03103-1']
2835,32822076,Neuromuscular fatigability amplitude and etiology are interrelated across muscles.,"NEW FINDINGS


What is the central question of this study? Is neuromuscular fatigability interrelated between different muscle groups from the same individual during isometric all-out exercise? What is the main finding and its importance? Although the average decrease can vary between muscles, an individual demonstrates interrelated fatigability etiology regardless of the muscle group tested. The inter-individual variability provides evidence of different profiles common between muscles which can be regarded as an individual characteristic.
ABSTRACT


Purpose Neuromuscular fatigability is commonly divided into central and peripheral origins. However, there is strong evidence of interactions between these two mechanisms. According to the idea that peripheral fatigability may be centrally regulated, one can hypothesize that neuromuscular fatigability would be correlated between different muscle groups at the individual level. Methods Thirty-two healthy participants (16 women and 16 men) completed two, 5 min fatiguing exercises (60 isometric maximal voluntary contractions (MVC)) with finger flexors (FF) and ankle plantar flexors (PF) in two randomized sessions. Neuromuscular testing was conducted before, during (every 6 MVCs) and directly after the fatigue procedure. Force asymptote (F A  ) was calculated as the asymptote of the force-time relationship. Pre to post-changes in exercise evoked force (ΔDb 100  ), voluntary activation (ΔVA) and central activation ratio (∆CAR) were also investigated. Results Significant correlations were found between FF and PF for F A  , ΔDb 100  and ΔVA (r = 0.65; r = 0.63 and r = 0.50 respectively). A significant negative correlation between ∆CAR and ∆Db 100  was evidenced for both PF (r = - 0.82) and FF (r = - 0.57). Conclusion Neuromuscular fatigability is correlated between different muscle groups at the individual level. Results of the current study support the idea that a restrained motor drive prevents large peripheral perturbations and that individuals exhibit correlated fatigability etiology regardless of the muscle group tested. Widely different central/peripheral profiles can be found amongst individuals and a part of the fatigability etiology can be regarded as an individual characteristic. This article is protected by copyright. All rights reserved.",2020,"Results Significant correlations were found between FF and PF for F A  , ΔDb 100  and ΔVA (r = ",['Methods Thirty-two healthy participants (16 women and 16 men'],['5\xa0min fatiguing exercises (60 isometric maximal voluntary contractions (MVC)) with finger flexors (FF) and ankle plantar flexors (PF'],"['exercise evoked force (ΔDb 100  ), voluntary activation (ΔVA) and central activation ratio (∆CAR']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",32.0,0.0203172,"Results Significant correlations were found between FF and PF for F A  , ΔDb 100  and ΔVA (r = ","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Chartogne', 'Affiliation': 'Le Mans Université, Nantes Université, Movement - Interactions - Performance, MIP, EA 4334, Le Mans, F-72000, France.'}, {'ForeName': 'Abderrahmane', 'Initials': 'A', 'LastName': 'Rahmani', 'Affiliation': 'Le Mans Université, Nantes Université, Movement - Interactions - Performance, MIP, EA 4334, Le Mans, F-72000, France.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Nicolon', 'Affiliation': 'Le Mans Université, Nantes Université, Movement - Interactions - Performance, MIP, EA 4334, Le Mans, F-72000, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Jubeau', 'Affiliation': 'Le Mans Université, Nantes Université, Movement - Interactions - Performance, MIP, EA 4334, Le Mans, F-72000, France.'}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Morel', 'Affiliation': 'Université Savoie Mont Blanc, Laboratoire Interuniversitaire de Biologie de la Motricité, EA 7424, Chambéry, F-73000, France.'}]",Experimental physiology,['10.1113/EP088682']
2836,32822131,Editorial Comment: Flexible ureterorenoscopy and laser lithotripsy with regional anesthesia vs general anesthesia: A prospective randomized study.,,2020,,[],"['Flexible ureterorenoscopy and laser lithotripsy with regional anesthesia vs general anesthesia', 'Editorial Comment']",[],[],"[{'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0282411', 'cui_str': 'Editorial Comment'}]",[],,0.018115,,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Denstedt', 'Affiliation': 'Division of Urology, Western University, Ontario, Canada.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0770.1']
2837,32822130,Flexible ureterorenoscopy and laser lithotripsy with regional anesthesia vs general anesthesia: A prospective randomized study.,"PURPOSE


To compare the effect of general anesthesia (GA) and regional anesthesia (RA) on f-URS outcomes and surgeon comfort.
MATERIAL AND METHODS


The study was conducted between June 2017 to January 2018 and data collection was applied in a prospective, randomized fashion. 120 patients participated in the study and were divided into RA group (n=56) and GA group (n=64). Demographic, operative and post-operative parameters of patients were analysed. The end point of this study was the effect of two anesthesia regimens on the comfort of the surgeon, and the comparability of feasibility and safety against perioperative complications.
RESULTS


The study including 120 randomized patients, 14 patients were excluded from the study and completed with 106 patients (45 in RA group and 61 in GA group). No difference was detected between the two groups in terms of preoperative data. During the monitorization of operative vital signs, 3 patients in RA group experienced bradycardia, and this finding was significant when compared with GA group (p=0.041). Additionally, 2 patients in RA group experienced mucosal tears and 1 patient experienced hemorrhage during the operation, but no complications were observed in the GA group (p=0.041). Postoperative surgeon comfort evaluation revealed statistically significant results in favor of GA group (p=0.001).
CONCLUSIONS


Both GA and RA are equally effective and safe anesthesia methods for f-URS procedures. However, RA group showed significantly increased likelihood of bradycardia and mucosal injury during surgery, and significantly decreased surgeon comfort during surgery.",2020,"Postoperative surgeon comfort evaluation revealed statistically significant results in favor of GA group (p=0.001).
","['June 2017 to January 2018 and data collection', '120 randomized patients, 14 patients were excluded from the study and completed with 106 patients (45 in RA group and 61 in GA group', '120 patients participated in the study and were divided into RA group (n=56) and GA group (n=64']","['general anesthesia (GA) and regional anesthesia (RA', 'Flexible ureterorenoscopy and laser lithotripsy with regional anesthesia vs general anesthesia']","['bradycardia', 'likelihood of bradycardia and mucosal injury', 'surgeon comfort', 'mucosal tears and 1 patient experienced hemorrhage']","[{'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0002911', 'cui_str': 'Regional anesthesia'}, {'cui': 'C0443220', 'cui_str': 'Flexible'}, {'cui': 'C1270970', 'cui_str': 'Transurethral ureterorenoscopy'}, {'cui': 'C0206099', 'cui_str': 'Laser Lithotripsy'}]","[{'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",120.0,0.0376006,"Postoperative surgeon comfort evaluation revealed statistically significant results in favor of GA group (p=0.001).
","[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Sahan', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Sarilar', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Mehmet Fatih', 'Initials': 'MF', 'LastName': 'Akbulut', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Eren', 'Initials': 'E', 'LastName': 'Demir', 'Affiliation': 'Department of Anesthesiology and Reanimation, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Metin', 'Initials': 'M', 'LastName': 'Savun', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Oznur', 'Initials': 'O', 'LastName': 'Sen', 'Affiliation': 'Department of Anesthesiology and Reanimation, Haseki Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Faruk', 'Initials': 'F', 'LastName': 'Ozgor', 'Affiliation': 'Department of Urology, Haseki Training and Research Hospital, Istanbul, Turkey.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2019.0770']
2838,32822141,"Editorial Comment: Ultra-hypofractionated versus conventionally fractionated radiothe-rapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial.",,2020,,['prostate cancer'],['Editorial Comment: Ultra-hypofractionated versus conventionally fractionated radiothe-rapy'],[],"[{'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0282411', 'cui_str': 'Editorial Comment'}]",[],,0.109669,,"[{'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lott', 'Affiliation': 'Instituto Nacional do Câncer - INCA, Rio de Janeiro, RJ, Brasil.'}]",International braz j urol : official journal of the Brazilian Society of Urology,['10.1590/S1677-5538.IBJU.2020.06.09']
2839,32817068,Ramucirumab in the second-line for patients with hepatocellular carcinoma and elevated alpha-fetoprotein: patient-reported outcomes across two randomised clinical trials.,"BACKGROUND


Symptoms of advanced hepatocellular carcinoma (HCC) represent a substantial burden for the patient and are important endpoints to assess when evaluating treatment. Patient-reported outcomes were evaluated in subjects with advanced HCC and baseline alpha-fetoprotein (AFP) ≥400 ng/mL treated with second-line ramucirumab.
PATIENTS AND METHODS


Patients with AFP≥400 ng/mL enrolled in the REACH or REACH-2 phase 3 studies were used in this analysis. Eligible patients had advanced HCC, Child-Pugh A, Eastern Cooperative Oncology Group performance status 0/1 and prior sorafenib. Patients received ramucirumab 8 mg/kg or placebo once every 2 weeks. Disease-related symptoms and health-related quality of life (HRQoL) were assessed with the Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index (FHSI)-8 and EuroQoL-5-Dimensions (EQ-5D) instruments, respectively. Time to deterioration (TTD) (≥3-point decrease in FHSI-8 total score;≥0.06-point decrease in EQ-5D score, from randomisation to first date of deterioration) was determined using Kaplan-Meier estimation and the Cox proportional hazards model. Both separate and pooled analyses for REACH AFP≥400 ng/mL and REACH-2 patients were conducted.
RESULTS


In the pooled population with AFP ≥400 ng/mL (n=542; ramucirumab, n=316; placebo, n=226), median TTD in FHSI-8 total score was prolonged with ramucirumab relative to placebo (3.3 vs 1.9 months; HR 0.725; (95% CI 0.559 to 0.941); p=0.0152), including significant differences in back pain (0.668; (0.497 to 0.899); p=0.0044), weight loss (0.699; (0.505 to 0.969); p=0.0231) and pain (0.769; (0.588 to 1.005); p=0.0248) symptoms. TTD in EQ-5D score was not significantly different between ramucirumab and placebo groups (median 2.9 vs 1.9 months). Results in the individual trials were consistent with these findings.
CONCLUSIONS


Ramucirumab in second-line treatment of advanced HCC demonstrates consistent benefit in the delay of deterioration in disease-related symptoms with no worsening of HRQoL. Taken with previously demonstrated ramucirumab-driven survival benefits in this setting, these data may inform patient-clinician discussions about the benefit-risk profile of this therapy.
TRIAL REGISTRATION NUMBER


NCT01140347; NCT02435433, NCT02435433.",2020,TTD in EQ-5D score was not significantly different between ramucirumab and placebo groups (median 2.9 vs 1.9 months).,"['patients with hepatocellular carcinoma and elevated alpha-fetoprotein', 'subjects with advanced HCC and baseline alpha-fetoprotein (AFP) ≥400', 'Patients with AFP≥400\u2009ng/mL enrolled in the REACH or REACH-2 phase 3 studies', 'Eligible patients had advanced HCC, Child-Pugh A, Eastern Cooperative Oncology Group performance status 0/1 and prior sorafenib', 'advanced hepatocellular carcinoma (HCC']","['ramucirumab 8\u2009mg/kg or placebo', 'Ramucirumab', 'placebo']","['TTD in EQ-5D score', 'Time to deterioration (TTD', 'Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index (FHSI)-8 and EuroQoL-5-Dimensions (EQ-5D', 'median TTD in FHSI-8 total score', 'back pain', 'weight loss', 'Disease-related symptoms and health-related quality of life (HRQoL', 'pain', 'EQ-5D score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0235971', 'cui_str': 'Alpha 1 foetoprotein increased'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0002210', 'cui_str': 'Alpha fetoprotein'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439560', 'cui_str': 'Phase 2'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.551931,TTD in EQ-5D score was not significantly different between ramucirumab and placebo groups (median 2.9 vs 1.9 months).,"[{'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA azhu@mgh.harvard.edu.'}, {'ForeName': 'Ryan D', 'Initials': 'RD', 'LastName': 'Nipp', 'Affiliation': 'Harvard Medical School, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'Division of Hematology/Oncology, Geffen School of Medicine, University of California-Los Angeles Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Galle', 'Affiliation': 'First Department of Internal Medicine, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Llovet', 'Affiliation': ""Translational Research Lab in Hepatic Oncology, Liver Unit, Institut d'Investigacions Biomediques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Jean-Frederic', 'Initials': 'JF', 'LastName': 'Blanc', 'Affiliation': 'Department of Hepatogastroenterology and Medical Oncology, CHU de Bordeaux Hôpital Haut-Lévêque, Pessac, France.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Chau', 'Affiliation': 'Department of Medicine, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Evanston, Illinois, USA.'}, {'ForeName': 'Allicia', 'Initials': 'A', 'LastName': 'Girvan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Jonathon', 'Initials': 'J', 'LastName': 'Gable', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Bowman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Chunxiao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Yanzhi', 'Initials': 'Y', 'LastName': 'Hsu', 'Affiliation': 'TG Therapeutics, New York City, New York, USA.'}, {'ForeName': 'Paolo B', 'Initials': 'PB', 'LastName': 'Abada', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana, USA.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Gastroenterology and Hepatology, Kindai University, Osaka, Japan.'}]",ESMO open,['10.1136/esmoopen-2020-000797']
2840,32817078,Efficacy and tolerability of high versus low dose lenalidomide maintenance therapy of multiple myeloma after autologous blood stem cell transplantation.,"PURPOSE


For multiple myeloma (MM), high-dose chemotherapy and autologous blood stem-cell transplantation (ASCT) followed by lenalidomide maintenance (LenMT) at 10-15 mg/day is considered standard of care. However, dose reductions due to side effects are common and median LenMT doses achieved over time may remain lower. Dose response during LenMT has never been investigated.
PATIENTS AND METHODS


In a multicenter, randomized, open-label trial, MM patients after ASCT and high-dose lenalidomide consolidation therapy (CT) at 25 mg/day were randomized to receive LenMT at either 25 or 5 mg/day. Primary endpoint was progression-free survival (PFS).
RESULTS


Ninety-four patients (median age 58 years) were randomized to either arm, with 22% having ISS stage 3 and 22% being in complete remission (CR). After median follow-up of 46.7 months, median doses of 14.5 and 5 mg/day were achieved in the two arms; 53% of dose reductions occurring during CT. In the high and the low dose arm, median PFS was 44.8 and 33.0 months (HR 0.65, 95%CI: 0.44-0.97; p=0.032), 36% and 23% of patients had stringent CR as best response (p=0.08), and 4-year OS was 79% and 67% (p=0.16), respectively. Hematologic toxicity, grade ≥3 neutropenia, and infections were initially more common with LenMT 25 mg, but decreased after dose-adjustments. SPM incidence and QoL scores in both arms were similar.
CONCLUSIONS


LenMT dose correlated with efficacy and toxicity. High rates of dose reductions during CT argue against a high starting dose. However, continuous up- and down-titration for each patient to the current maximum tolerated dose is prudent.",2020,"Hematologic toxicity, grade ≥3 neutropenia, and infections were initially more common with LenMT 25 mg, but decreased after dose-adjustments.","['Ninety-four patients (median age 58 years', 'multiple myeloma after autologous blood stem cell transplantation']","['lenalidomide maintenance therapy', 'ASCT and high-dose lenalidomide consolidation therapy (CT', 'chemotherapy and autologous blood stem-cell transplantation (ASCT) followed by lenalidomide maintenance (LenMT', 'LenMT']","['Hematologic toxicity, grade ≥3 neutropenia, and infections', '4-year OS', 'Efficacy and tolerability', 'SPM incidence and QoL scores', 'efficacy and toxicity', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0038111', 'cui_str': 'Saint Pierre and Miquelon'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",94.0,0.163084,"Hematologic toxicity, grade ≥3 neutropenia, and infections were initially more common with LenMT 25 mg, but decreased after dose-adjustments.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Fenk', 'Affiliation': 'Dept. of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf fenk@med.uni-duesseldorf.de.'}, {'ForeName': 'Aristoteles', 'Initials': 'A', 'LastName': 'Giagounidis', 'Affiliation': 'Klinik für Onkologie, Hämatologie und Palliativmedizin, Marien Hospital Düsseldorf.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'Department of Internal Medicine V and National Center of Tumor Diseases (NCT), Heidelberg University.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heinsch', 'Affiliation': 'Helios St. Johannes Hospital Duisburg.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Rummel', 'Affiliation': 'Departement of Hematology and Oncology, Justus-Liebig-University.'}, {'ForeName': 'Nicolaus', 'Initials': 'N', 'LastName': 'Kröger', 'Affiliation': 'Department of Stem Cell Transplantation, University Medical Center Hamburg-Eppendorf.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Boquoi', 'Affiliation': 'Hematology, Oncology and Clinical Immunology, University Duesseldorf.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Lopez', 'Affiliation': 'Dept. of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Gerrlich', 'Affiliation': 'Dept. of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Baier', 'Affiliation': 'Dept. of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf.'}, {'ForeName': 'Svenja', 'Initials': 'S', 'LastName': 'Liesenjohann', 'Affiliation': 'Dept. of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Hauck', 'Affiliation': 'Dept. of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf.'}, {'ForeName': 'Ingrida', 'Initials': 'I', 'LastName': 'Savickaite', 'Affiliation': 'Dept. of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf.'}, {'ForeName': 'Elias Karl', 'Initials': 'EK', 'LastName': 'Mai', 'Affiliation': 'Department of Internal Medicine V, Heidelberg University Hospital.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Aul', 'Affiliation': 'Helios St. Johannes Hospital Duisburg.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Strapatsas', 'Affiliation': 'Dept. of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Dienst', 'Affiliation': 'Hematology and Oncology, Heinrich-Heine-University.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Kondakci', 'Affiliation': 'Dept. of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Haas', 'Affiliation': 'Dept. of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Kobbe', 'Affiliation': 'Dept. of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0841']
2841,32817130,Gemcitabine/nab-paclitaxel with pamrevlumab: a novel drug combination and trial design for the treatment of locally advanced pancreatic cancer.,"PURPOSE


Pancreatic ductal adenocarcinomas exhibit a high degree of desmoplasia due to extensive extracellular matrix deposition. Encasement of mesenteric vessels by stroma in locally advanced pancreatic cancer (LAPC) prevents surgical resection. This study sought to determine if the addition of a monoclonal antibody to connective tissue growth factor, pamrevlumab, to neoadjuvant chemotherapy would be safe and lead to improved resectability in this surgically adverse patient population.
METHODS


In this phase I/II trial, 37 patients with LAPC were randomised 2:1 to gemcitabine/nab-paclitaxel plus (Arm A, n=24) or minus (Arm B, n=13) pamrevlumab. Those who completed six cycles of treatment were assessed for surgical eligibility by protocol-defined criteria. Resection rates, progression-free and overall survival were evaluated.
RESULTS


Eighteen (75%) patients in Arm A and seven (54%) in Arm B completed six cycles of therapy with similar toxicity patterns. In Arms A and B, carbohydrate antigen 19-9 response, as defined by ≥50% decline from baseline, occurred in 13 (65%) and 5 (42%), respectively. Sixteen (16%) per cent of patients were radiographically downstaged by National Comprehensive Cancer Network criteria (5 in Arm A (21%) and 1 (8%) in Arm B). Positron emission tomography normalised in 9 (38%) vs 3 (23%) of patients in Arm A vs Arm B, respectively, and correlated with surgical exploration. Eligibility for surgical exploration was 17 (71%) vs 2 (15%) (p=0.0019) and resection was achieved in 8 (33%) vs 1 (8%) of patients in Arm A vs Arm B (p=0.1193), respectively. Postoperative complication rates were not different between arms.
CONCLUSIONS


Neoadjuvant chemotherapy with pamrevlumab holds promise for enhancing resection rates in patients with LAPC without added toxicity. This combination merits evaluation in a larger patient cohort.",2020,"Eligibility for surgical exploration was 17 (71%) vs 2 (15%) (p=0.0019) and resection was achieved in 8 (33%) vs 1 (8%) of patients in Arm A vs Arm B (p=0.1193), respectively.","['37 patients with LAPC', 'patients with LAPC without added toxicity', 'surgically adverse patient population', 'locally advanced pancreatic cancer (LAPC', 'locally advanced pancreatic cancer']","['Gemcitabine/nab-paclitaxel with pamrevlumab', 'gemcitabine/nab-paclitaxel plus']","['Eligibility for surgical exploration', 'Positron emission tomography normalised', 'enhancing resection rates', 'Resection rates, progression-free and overall survival', 'Postoperative complication rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0184899', 'cui_str': 'Exploratory incision'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",37.0,0.0920044,"Eligibility for surgical exploration was 17 (71%) vs 2 (15%) (p=0.0019) and resection was achieved in 8 (33%) vs 1 (8%) of patients in Arm A vs Arm B (p=0.1193), respectively.","[{'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Picozzi', 'Affiliation': 'Virginia Mason Medical Center, Seattle, Washington, USA vincent.picozzi@vmmc.org.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'Alseidi', 'Affiliation': 'Virginia Mason Medical Center, Seattle, Washington, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Winter', 'Affiliation': 'Thomas Jefferson Medical Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pishvaian', 'Affiliation': 'Georgetown Medical Center, Washington, DC, USA.'}, {'ForeName': 'Kabir', 'Initials': 'K', 'LastName': 'Mody', 'Affiliation': 'Mayo Clinic Jacksonville, Jacksonville, Florida, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Glaspy', 'Affiliation': 'UCLA Medical Center, Los Angeles, California, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Larson', 'Affiliation': 'Virginia Piper Cancer Institute, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Matrana', 'Affiliation': 'Ochsner Clinic Foundation, New Orleans, Louisiana, USA.'}, {'ForeName': 'Mairead', 'Initials': 'M', 'LastName': 'Carney', 'Affiliation': 'Clinical Development, FibroGen, Inc, San Francisco, California, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Porter', 'Affiliation': 'Clinical Development, FibroGen, Inc, San Francisco, California, USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Kouchakji', 'Affiliation': 'Clinical Development, FibroGen, Inc, San Francisco, California, USA.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Rocha', 'Affiliation': 'Virginia Mason Medical Center, Seattle, Washington, USA.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Carrier', 'Affiliation': 'Clinical Development, FibroGen, Inc, San Francisco, California, USA.'}]",ESMO open,['10.1136/esmoopen-2019-000668']
2842,32817131,Effect of trifluridine/tipiracil in patients treated in RECOURSE by prognostic factors at baseline: an exploratory analysis.,"BACKGROUND


The choice of treatment in patients with metastatic colorectal cancer (mCRC) is generally influenced by tumour and patient characteristics, treatment efficacy and tolerability, and quality of life. Better patient selection might lead to improved outcomes.
METHODS


This post hoc exploratory analysis examined the effect of prognostic factors on outcomes in the Randomized, Double-blind, Phase 3 Study of trifluridine tipiracil (FTD/TPI) plus Best Supportive Care (BSC) versus Placebo plus BSC in Patients with mCRC Refractory to Standard Chemotherapies (RECOURSE) trial. Patients were redivided by prognosis into two subgroups: those with <3 metastatic sites at randomisation (low tumour burden) and ≥18 months from diagnosis of metastatic disease to randomisation (indolent disease) were included in the good prognostic characteristics (GPC) subgroup; the remaining patients were considered to have poor prognostic characteristics (PPC).
RESULTS


GPC patients (n=386) had improved outcome versus PPC patients (n=414) in both the trifluridine/tipiracil and placebo arms. GPC patients receiving trifluridine/tipiracil (n=261) had an improved median overall survival (9.3 vs 5.3 months; HR (95% CI) 0.46 (0.37 to 0.57), p<0.0001) and progression-free survival (3.3 vs 1.9 months; HR (95% CI) 0.56 (0.46 to 0.67), p<0.0001) than PPC patients receiving trifluridine/tipiracil (n=273). Improvements in survival were irrespective of age, Eastern Cooperative Oncology Group Performance Status (ECOG PS),  KRAS  mutational status, and site of metastases at randomisation. In the trifluridine/tipiracil arm, time to deterioration of ECOG PS to ≥2 and proportion of patients with PS=0-1 discontinuing treatment were longer for GPC than for PPC patients (7.8 vs 4.2 months and 89.1% vs 78.4%, respectively).
CONCLUSION


Low tumour burden and indolent disease were factors of good prognosis in late-line mCRC, with patients experiencing longer progression-free survival and greater overall survival.",2020,"RESULTS


GPC patients (n=386) had improved outcome versus PPC patients (n=414) in both the trifluridine/tipiracil and placebo arms.","['Patients with mCRC Refractory to Standard Chemotherapies (RECOURSE) trial', 'GPC patients receiving', 'patients with metastatic colorectal cancer (mCRC', 'Patients were redivided by prognosis into two subgroups: those with <3 metastatic sites at randomisation (low tumour burden) and ≥18 months from diagnosis of metastatic disease to randomisation (indolent disease) were included in the good prognostic characteristics (GPC) subgroup; the remaining patients were considered to have poor prognostic characteristics (PPC']","['trifluridine/tipiracil', 'trifluridine tipiracil (FTD/TPI) plus Best Supportive Care (BSC) versus Placebo plus BSC']","['Performance Status (ECOG PS),  KRAS  mutational status, and site of metastases', 'progression-free survival', 'overall survival', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0033325', 'cui_str': 'Determination of prognosis'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C4055631', 'cui_str': 'Tipiracil- and trifluridine-containing product'}, {'cui': 'C0338451', 'cui_str': 'Frontotemporal dementia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.322874,"RESULTS


GPC patients (n=386) had improved outcome versus PPC patients (n=414) in both the trifluridine/tipiracil and placebo arms.","[{'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron Institute of Oncology, UVic-UCC, Medical Oncology, Vall d'Hebron Hospital, Barcelona, Catalunya, Spain jtabernero@vhio.net.""}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Argiles', 'Affiliation': ""Vall d'Hebron Institute of Oncology, UVic-UCC, IOB-QuironMedical Oncology, Vall d'Hebron Hospital, Barcelona, Catalunya, Spain.""}, {'ForeName': 'Alberto F', 'Initials': 'AF', 'LastName': 'Sobrero', 'Affiliation': ""Medical Oncology, Ospedale Policlinico San Martino Istituto di Ricovero e Cura a Carattere Scientifico per l'Oncologia, Genova, Liguria, Italy.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Borg', 'Affiliation': 'Department of Medical Oncology, University Hospital Centre Besançon, Besancon, Bourgogne Franche-Comté, France.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ohtsu', 'Affiliation': 'Kashiwa, National Cancer Center-Hospital East, Kashiwa, Chiba, Japan.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Department of Medical Oncology, Dana Farber Cancer Institute, Boston, Massachusetts, USA.'}, {'ForeName': 'Loick', 'Initials': 'L', 'LastName': 'Vidot', 'Affiliation': 'Centre of EXcellence Methodology and Valorization of Data (CentEX MVD), Institut de Recherches Internationales Servier, Suresnes, France.'}, {'ForeName': 'Shanti R', 'Initials': 'SR', 'LastName': 'Moreno Vera', 'Affiliation': 'Global Medical Affairs, Les Laboratoires Servier SAS, Suresnes, Île-de-France, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Digestive Oncology, KU Leuven University Hospitals Leuven, Leuven, Flanders, Belgium.'}]",ESMO open,['10.1136/esmoopen-2020-000752']
2843,32817266,Telehealth Home Monitoring and Postcardiac Surgery for Congenital Heart Disease.,"OBJECTIVES


To test the effect of a 4-month telehealth home monitoring program (REACH), layered on usual care, on postdischarge outcomes in parents of infants recovering from cardiac surgery and their infants.
METHODS


Randomized trial of infants discharged from the hospital after cardiac surgery for congenital heart disease. Consecutive infants with complex congenital heart disease undergoing cardiac surgery within 21 days of life were enrolled at 3 university-affiliated pediatric cardiac centers.
RESULTS


From 2012 to 2016, 219 parent-infant dyads were enrolled; 109 were randomly assigned to the intervention group and 110 to the control group. At 4 months postdischarge, parenting stress was not significantly different between groups (total Parenting Stress Index in the intervention group was 220 and in the control group was 215;  P  = .61). The percentages of parents who met posttraumatic stress disorder (PTSD) criteria and parent quality of life inventory scores were also not significantly different between the 2 groups (PTSD in the intervention group was 18% and was 18% in the control group;  P  =.56; the mean Ulm Quality of Life Inventory for Parents in the intervention group was 71 andwas 70 in the control group;  P  = .88). Infant growth in both groups was suboptimal (the mean weight-for-age  z  scores were -1.1 in the intervention group and -1.2 in the control group;  P  = .56), and more infants in the intervention group were readmitted to the hospital (66% in the intervention group versus 57% in the control group;  P  < .001).
CONCLUSIONS


When added to usual care, the REACH intervention was not associated with an improvement in parent or infant outcomes. Four months after neonatal heart surgery, ∼20% of parents demonstrate PTSD symptoms. Suboptimal infant growth and hospital readmissions were common.",2020,"At 4 months postdischarge, parenting stress was not significantly different between groups (total Parenting Stress Index in the intervention group was 220 and in the control group was 215;  P  = .61).","['Congenital Heart Disease', 'parents of infants recovering from cardiac surgery and their infants', 'From 2012 to 2016', '219 parent-infant dyads were enrolled; 109', 'Consecutive infants with complex congenital heart disease undergoing cardiac surgery within 21 days of life were enrolled at 3 university-affiliated pediatric cardiac centers', 'infants discharged from the hospital after cardiac surgery for congenital heart disease']","['telehealth home monitoring program (REACH), layered on usual care']","['readmitted to the hospital', 'Suboptimal infant growth and hospital readmissions', 'total Parenting Stress Index', 'posttraumatic stress disorder (PTSD) criteria and parent quality of life inventory scores', 'Infant growth', 'parenting stress', 'mean Ulm Quality of Life Inventory']","[{'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0471754,"At 4 months postdischarge, parenting stress was not significantly different between groups (total Parenting Stress Index in the intervention group was 220 and in the control group was 215;  P  = .61).","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Medoff Cooper', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania; medoff@upenn.edu.'}, {'ForeName': 'Bradley S', 'Initials': 'BS', 'LastName': 'Marino', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.""}, {'ForeName': 'Desiree A', 'Initials': 'DA', 'LastName': 'Fleck', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Amy Jo', 'Initials': 'AJ', 'LastName': 'Lisanti', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Nadya', 'Initials': 'N', 'LastName': 'Golfenshtein', 'Affiliation': 'Department of Nursing, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Ravishankar', 'Affiliation': 'Division of Cardiology, Department of Pediatrics and.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Costello', 'Affiliation': ""Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois.""}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Hanlon', 'Affiliation': 'Department of Statistics, College of Science, Virginia Polytechnic Institute and State University, Blacksburg, Virginia; and.'}, {'ForeName': 'Martha A Q', 'Initials': 'MAQ', 'LastName': 'Curley', 'Affiliation': 'Department of Anesthesia and Critical Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Pediatrics,['10.1542/peds.2020-0531']
2844,32827209,Effect of the Combination of Ketorolac and Bupivacaine on Transversus Abdominis Plane Block for Postoperative Analgesia After Gynecological Laparoscopic Surgery.,"BACKGROUND This study assessed the additional benefits of bupivacaine when combined with ketorolac for transversus abdominis plane (TAP) block after gynecological laparoscopic surgery. MATERIAL AND METHODS This randomized, observer-blind trial recruited 153 patients who underwent gynecological laparoscopic surgery. Patients were randomly assigned to receive bupivacaine combined with ketorolac 15 mg/side for TAP block (TK group), bupivacaine for TAP block and 30 mg postoperative intravenous ketorolac (T group), or 30 mg postoperative intravenous ketorolac alone (C group). The primary endpoints included consumption of sufentanil for 24 h postoperatively, actual press times of the patient-controlled analgesia (PCA) pump, and effective press times of the PCA pump, whereas the secondary endpoints included numerical rating scale (NRS) pain scores at rest and during activity, satisfaction with analgesia, episodes of nausea and vomiting and length of hospital stay. RESULTS Sufentanil consumption, actual press times of the PCA pump, and effective press times of the PCA pump were lower in the TK and T groups than in the C group. NRS scores at rest and during activity at 1, 2, 4, 6, and 24 hours were significantly lower in the TK and T groups than in the C group. The TK and T groups showed greater satisfaction with analgesia than the C group, while the TK group showed greater overall satisfaction than the C group. Lengths of stay, rates of nausea and vomiting, and venting times did not differ significantly among the three groups. CONCLUSIONS Combined ketorolac and bupivacaine as TAP block improved the effectiveness of analgesia without increasing adverse events. Trial registration number: ChiCTR1900022577.",2020,"NRS scores at rest and during activity at 1, 2, 4, 6, and 24 hours were significantly lower in the TK and T groups than in the C group.","['transversus abdominis plane (TAP) block after gynecological laparoscopic surgery', '153 patients who underwent']","['bupivacaine combined with ketorolac 15 mg/side for TAP block (TK group), bupivacaine for TAP block and 30 mg postoperative intravenous ketorolac (T group), or 30 mg postoperative intravenous ketorolac alone', 'gynecological laparoscopic surgery', 'bupivacaine', 'Ketorolac and Bupivacaine', 'Gynecological Laparoscopic Surgery', 'ketorolac']","['overall satisfaction', 'satisfaction with analgesia', 'effective press times of the PCA pump', 'numerical rating scale (NRS) pain scores at rest and during activity, satisfaction with analgesia, episodes of nausea and vomiting and length of hospital stay', 'consumption of sufentanil for 24 h postoperatively, actual press times of the patient-controlled analgesia (PCA) pump, and effective press times of the PCA pump', 'Lengths of stay, rates of nausea and vomiting, and venting times', 'Transversus Abdominis Plane Block for Postoperative Analgesia', 'NRS scores']","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",153.0,0.160045,"NRS scores at rest and during activity at 1, 2, 4, 6, and 24 hours were significantly lower in the TK and T groups than in the C group.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China (mainland).'}, {'ForeName': 'Shao-Qiang', 'Initials': 'SQ', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China (mainland).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiao', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China (mainland).'}, {'ForeName': 'Xiao-Min', 'Initials': 'XM', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.925006']
2845,32827221,Transcranial magnetic stimulation promotes gait training in Parkinson's disease.,"OBJECTIVE


To determine whether priming with 1 Hz or 25 Hz repetitive transcranial magnetic stimulation (rTMS) will enhance the benefits from treadmill training up to three-month post-intervention in people with Parkinson's disease (PD), and to evaluate the underlying changes in cortical excitability.
METHODS


This randomized double-blind, placebo-controlled trial was conducted between Oct 2016 and Dec 2018. Fifty-one participants with PD were randomized to receive 12 sessions of rTMS (25 Hz, 1 Hz or sham) followed by treadmill training. All participants were assessed at baseline, one-day, one-month and three-month post-intervention. Primary outcome was fastest walking speed and secondary outcomes were timed up-and-go test (TUG), dual-task TUG (DT-TUG), motor section of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), and electrophysiological evaluation of cortical excitability by TMS.
RESULTS


The 1 Hz and 25 Hz rTMS groups produced a greater improvement in fastest walking speed at one-day and three-month post-intervention than the sham group. Only 1 and 25 Hz rTMS groups sustained the improvements in TUG, and had a significant improvement in DT-TUG and MDS-UPDRS-III for up to three months. Behavioral improvements correlated with increased cortical silent period and short-interval intracortical inhibition in both groups receiving real rTMS. Interpretation Priming with 1 Hz and 25 Hz rTMS can augment the benefits of treadmill training and led to long-term motor improvement up to three-month post-intervention. The motor improvement at follow-up was associated with a normalization of cortical excitability, which in turn suggests an alteration of the homeostatic plasticity range. Rebalancing cortical excitability by rTMS appears critical for plasticity induction. This article is protected by copyright. All rights reserved.",2020,Behavioral improvements correlated with increased cortical silent period and short-interval intracortical inhibition in both groups receiving real rTMS.,"['Oct 2016 and Dec 2018', ""Parkinson's disease"", 'Fifty-one participants with PD', ""people with Parkinson's disease (PD""]","['Transcranial magnetic stimulation promotes gait training', '1 Hz or 25 Hz repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'rTMS (25 Hz, 1 Hz or sham) followed by treadmill training', 'placebo']","['fastest walking speed', 'cortical silent period and short-interval intracortical inhibition', 'DT-TUG and MDS-UPDRS-III', ""fastest walking speed and secondary outcomes were timed up-and-go test (TUG), dual-task TUG (DT-TUG), motor section of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), and electrophysiological evaluation of cortical excitability by TMS""]","[{'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0026650', 'cui_str': 'Movement disorder'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",51.0,0.305734,Behavioral improvements correlated with increased cortical silent period and short-interval intracortical inhibition in both groups receiving real rTMS.,"[{'ForeName': 'Chloe Lau-Ha', 'Initials': 'CL', 'LastName': 'Chung', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Margaret Kit-Yi', 'Initials': 'MK', 'LastName': 'Mak', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hallett', 'Affiliation': 'Human Motor Control Section, Medical Neurology Branch, National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland, USA.'}]",Annals of neurology,['10.1002/ana.25881']
2846,32827227,Effects of activated charcoal powder combined with toothpastes on enamel color change and surface properties.,"AIM


To evaluate the effects of activated charcoal powder (COAL) combined with regular (RT) or whitening (WT) toothpastes on enamel color and surface in comparison to carbamide peroxide (CP).
METHODS


Dental blocks (n = 10/group) were randomly divided into COAL, COAL/RT, COAL/WT, CP, CP/RT, CP/WT, RT, WT, and CONT (without treatment). Simulated toothbrushing and whitening treatments were followed by colorimetric (ΔE 00  , L*, a*, b*), surface roughness (Ra), and enamel topography assays. ΔE 00  was submitted to two-way ANOVA and Tukey test. Color coordinates and Ra were tested with three-way repeated measures ANOVA (α = 5%).
RESULTS


COAL exhibited greater ΔE 00  than CONT (P = .048), but it did not enhance ΔE 00  promoted by RT or WT (P > .05). COAL alone increased Ra (P < .001) and altered enamel topography. COAL did not increase Ra caused by RT and WT (P > .05). CP exhibited the highest ΔE 00  (P < .05), but it raised Ra and changed enamel topography to a less extent than COAL.
CONCLUSION


Even though charcoal powder did not increase enamel Ra when combined with toothpastes, the topography was negatively impacted by COAL. Also, COAL was unable to enhance the color change of RT and WT, or reach the effectiveness of CP.
CLINICAL SIGNIFICANCE


The use of activated charcoal-based product, claimed as a natural whitener, before brushing with toothpastes is not only ineffective to change the color of teeth, but also it might result in alterations on the enamel surface. Whitening with CP, instead, was effective during the same period of treatment, which still represents a more appropriate technique to whiten teeth.",2020,"CP exhibited the highest ΔE 00  (P < .05), but it raised Ra and changed enamel topography to a less extent than COAL.
",['Dental blocks (n = 10/group'],"['COAL, COAL/RT, COAL/WT, CP, CP/RT, CP/WT, RT, WT, and CONT (without treatment', 'Whitening with CP', 'activated charcoal powder combined with toothpastes', 'COAL', 'activated charcoal powder (COAL) combined with regular (RT) or whitening (WT) toothpastes']","['altered enamel topography', 'enamel color change and surface properties', 'Ra', 'enamel Ra', 'surface roughness (Ra), and enamel topography assays']","[{'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0007955', 'cui_str': 'Charcoal'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0108342', 'cui_str': 'carbamide peroxide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001275', 'cui_str': 'Activated Charcoal'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040462', 'cui_str': 'Toothpaste'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0475330', 'cui_str': 'Color change'}, {'cui': 'C0038884', 'cui_str': 'Surface Properties'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]",,0.0121497,"CP exhibited the highest ΔE 00  (P < .05), but it raised Ra and changed enamel topography to a less extent than COAL.
","[{'ForeName': 'Samuel da Silva', 'Initials': 'SDS', 'LastName': 'Palandi', 'Affiliation': 'Department of Restorative Dentistry, Piracicaba Dental School, University of Campinas, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Kury', 'Affiliation': 'Department of Restorative Dentistry, Piracicaba Dental School, University of Campinas, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Mayara Zaghi Dal', 'Initials': 'MZD', 'LastName': 'Picolo', 'Affiliation': 'Department of Restorative Dentistry, Piracicaba Dental School, University of Campinas, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Camila Siqueira Silva', 'Initials': 'CSS', 'LastName': 'Coelho', 'Affiliation': 'Department of Restorative Dentistry, Piracicaba Dental School, University of Campinas, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Cavalli', 'Affiliation': 'Department of Restorative Dentistry, Piracicaba Dental School, University of Campinas, Piracicaba, São Paulo, Brazil.'}]",Journal of esthetic and restorative dentistry : official publication of the American Academy of Esthetic Dentistry ... [et al.],['10.1111/jerd.12646']
2847,32827269,Increase in endogenous glucose production with SGLT2 inhibition is attenuated in individuals who underwent kidney transplantation and bilateral native nephrectomy.,"AIMS/HYPOTHESIS


The glucosuria induced by sodium-glucose cotransporter 2 (SGLT2) inhibition stimulates endogenous (hepatic) glucose production (EGP), blunting the decline in HbA 1c . We hypothesised that, in response to glucosuria, a renal signal is generated and stimulates EGP. To examine the effect of acute administration of SGLT2 inhibitors on EGP, we studied non-diabetic individuals who had undergone renal transplant with and without removal of native kidneys.
METHODS


This was a parallel, randomised, double-blind, placebo-controlled, single-centre study, designed to evaluate the effect of a single dose of dapagliflozin or placebo on EGP determined by stable-tracer technique. We recruited non-diabetic individuals who were 30-65 years old, with a BMI of 25-35 kg/m 2  and stable body weight (±2 kg) over the preceding 3 months, and HbA 1c  <42 mmol/mol (6.0%). Participants had undergone renal transplant with and without removal of native kidneys and were on a stable dose of immunosuppressive medications. Participants received a single dose of dapagliflozin 10 mg or placebo on two separate days, at a 5- to 14-day interval, according to randomisation performed by our hospital pharmacy, which provided dapagliflozin and matching placebo, packaged in bulk bottles that were sequentially numbered. Both participants and investigators were blinded to group assignment.
RESULTS


Twenty non-diabetic renal transplant patients (ten with residual native kidneys, ten with bilateral nephrectomy) participated in the study. Dapagliflozin induced greater glucosuria in individuals with residual native kidneys vs nephrectomised individuals (8.6 ± 1.1 vs 5.5 ± 0.5 g/6 h; p = 0.02; data not shown). During the 6 h study period, plasma glucose decreased only slightly and similarly in both groups, with no difference compared with placebo (data not shown). Following administration of placebo, there was a progressive time-related decline in EGP that was similar in both nephrectomised individuals and individuals with residual native kidneys. Following dapagliflozin administration, EGP declined in both groups, but the differences between the decrement in EGP with dapagliflozin and placebo in the group with bilateral nephrectomy (Δ = 1.11 ± 0.72 μmol min -1  kg -1 ) was significantly lower (p = 0.03) than in the residual native kidney group (Δ = 2.56 ± 0.33 μmol min -1  kg -1 ). In the population treated with dapagliflozin, urinary glucose excretion was correlated with EGP (r = 0.34, p < 0.05). Plasma insulin, C-peptide, glucagon, prehepatic insulin:glucagon ratio, lactate, alanine and pyruvate concentrations were similar following placebo and dapagliflozin treatment. β-Hydroxybutyrate increased with dapagliflozin treatment in the residual native kidney group, while a small increase was observed only at 360 min in the nephrectomy group. Plasma adrenaline (epinephrine) did not change after dapagliflozin and placebo treatment in either group. Following dapagliflozin administration, plasma noradrenaline (norepinephrine) increased slightly in the residual native kidney group and decreased in the nephrectomy group.
CONCLUSIONS/INTERPRETATION


In nephrectomised individuals, the hepatic compensatory response to acute SGLT2 inhibitor-induced glucosuria was attenuated, as compared with individuals with residual native kidneys, suggesting that SGLT2 inhibitor-mediated stimulation of hepatic glucose production via efferent renal nerves occurs in an attempt to compensate for the urinary glucose loss (i.e. a renal-hepatic axis).
TRIAL REGISTRATION


ClinicalTrials.gov NCT03168295 FUNDING: This protocol was supported by Qatar National Research Fund (QNRF) Award No. NPRP 8-311-3-062 and NIH grant DK024092-38. Graphical abstract.",2020,"Following dapagliflozin administration, plasma noradrenaline (norepinephrine) increased slightly in the residual native kidney group and decreased in the nephrectomy group.
","['diabetic individuals who had undergone renal transplant with and without removal of native kidneys', 'Participants had undergone renal transplant with and without removal of native kidneys and were on a stable dose of immunosuppressive medications', 'Twenty non-diabetic renal transplant patients (ten with residual native kidneys, ten with bilateral nephrectomy) participated in the study', 'individuals who underwent kidney transplantation and bilateral native nephrectomy', 'recruited non-diabetic individuals who were 30-65\xa0years old, with a BMI of 25-35\xa0kg/m 2  and stable body weight (±2\xa0kg) over the preceding 3\xa0months, and HbA 1c  <42\xa0mmol/mol (6.0']","['dapagliflozin or placebo', 'Plasma adrenaline (epinephrine', 'dapagliflozin 10\xa0mg or placebo', 'dapagliflozin and matching placebo, packaged in bulk bottles that were sequentially numbered', 'SGLT2 inhibitors', 'dapagliflozin', 'Dapagliflozin', 'dapagliflozin and placebo', 'placebo']","['Plasma insulin, C-peptide, glucagon, prehepatic insulin:glucagon ratio, lactate, alanine and pyruvate concentrations', 'plasma noradrenaline (norepinephrine', 'glucosuria', 'urinary glucose excretion', 'plasma glucose', 'progressive time-related decline in EGP', 'β-Hydroxybutyrate', 'endogenous (hepatic) glucose production (EGP', 'EGP']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0194084', 'cui_str': 'Bilateral total nephrectomy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0027695', 'cui_str': 'Kidney excision'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0857690', 'cui_str': 'Plasma insulin'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028351', 'cui_str': 'Norepinephrine'}, {'cui': 'C0017979', 'cui_str': 'Glycosuria'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}]",,0.3258,"Following dapagliflozin administration, plasma noradrenaline (norepinephrine) increased slightly in the residual native kidney group and decreased in the nephrectomy group.
","[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Daniele', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Solis-Herrera', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Dardano', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mari', 'Affiliation': 'Metabolic Unit, CNR Institute of Neuroscience, Padova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Tura', 'Affiliation': 'Metabolic Unit, CNR Institute of Neuroscience, Padova, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Giusti', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Jancy J', 'Initials': 'JJ', 'LastName': 'Kurumthodathu', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Campi', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Saba', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Bianchi', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Tregnaghi', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Maria Francesca', 'Initials': 'MF', 'LastName': 'Egidi', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Abdul-Ghani', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'DeFronzo', 'Affiliation': 'Division of Diabetes, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Department of Clinical and Experimental Medicine, Section of Metabolic Diseases and Diabetes, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy. stefano.delprato@med.unipi.it.'}]",Diabetologia,['10.1007/s00125-020-05254-w']
2848,32827290,"Evaluating the Effectiveness of NORTH STAR: a Community-Based Framework to Reduce Adult Substance Misuse, Intimate Partner Violence, Child Abuse, Suicidality, and Cumulative Risk.","We evaluated the effectiveness of NORTH STAR, a community assessment, planning, and action framework to reduce the prevalence of several secretive adult problems (hazardous drinking, controlled prescription drug misuse, suicidality, and clinically significant intimate partner violence and child abuse [both emotional and physical]) as well as cumulative risk. One-third of US Air Force (AF) bases worldwide were randomly assigned to NORTH STAR (n = 12) or an assessment-and-feedback-only condition (n = 12). Two AF-wide, cross-sectional, anonymous, web-based surveys were conducted of randomly selected samples assessing risk/protective factors and outcomes. Process data regarding attitudes, context, and implementation factors were also collected from Community Action Team members. Analyzed at the level of individuals, NORTH STAR significantly reduced intimate partner emotional abuse, child physical abuse, and suicidality, at sites with supportive conditions for community prevention (i.e., moderation effects). Given its relatively low cost, use of empirically supported light-touch interventions, and emphasis on sustainability with existing resources, NORTH STAR may be a useful framework for the prevention of a range of adult behavioral health problems that are difficult to impact.",2020,"Analyzed at the level of individuals, NORTH STAR significantly reduced intimate partner emotional abuse, child physical abuse, and suicidality, at sites with supportive conditions for community prevention (i.e., moderation effects).",[],['NORTH STAR'],"['intimate partner emotional abuse, child physical abuse, and suicidality']",[],"[{'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}]","[{'cui': 'C0699756', 'cui_str': 'Intimate'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0730557', 'cui_str': 'Emotional abuse'}, {'cui': 'C0236861', 'cui_str': 'Physical child abuse'}]",,0.0178108,"Analyzed at the level of individuals, NORTH STAR significantly reduced intimate partner emotional abuse, child physical abuse, and suicidality, at sites with supportive conditions for community prevention (i.e., moderation effects).","[{'ForeName': 'Amy M Smith', 'Initials': 'AMS', 'LastName': 'Slep', 'Affiliation': 'New York University, New York, NY, USA. Amy.Slep@nyu.edu.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Heyman', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Lorber', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'Katherine J W', 'Initials': 'KJW', 'LastName': 'Baucom', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Linkh', 'Affiliation': 'Ellsworth Air Force Base, AFB, SD, Ellsworth, IO, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-020-01156-w']
2849,32822218,Promote or inhibit: An inverted U-shaped effect of workload on driver takeover performance.,"OBJECTIVE


In conditional automated driving (SAE Level 3), drivers are required to take over their vehicles when the automated systems fail. Non-driving related tasks (NDRTs) can positively or negatively affect takeover safety, but the underlying reasons for this inconsistency remain unclear. This study aims to investigate how various workload levels generated by NDRTs may influence the takeover performance of drivers and the lead time they require.
METHOD


Fifty drivers were randomly distributed into five groups, which corresponded to five workload levels (1-4 levels generated by Tetris game; control level generated by monitoring). Each driver completed vehicle takeover tasks upon receiving takeover requests with various lead times (3, 5, 7, 9, and 11 s) while engaging in NDRTs. The drivers' takeover performance and subjective opinions were recorded.
RESULTS


Drivers in the moderate workload condition (i.e., level 3) had significantly shorter takeover times and better takeover quality than those in the lower (i.e., level 1 and level 2) or higher (i.e., level 4) workload conditions. They also subjectively required less lead time in the moderate condition. Moreover, the drivers rated 7 s as the most appropriate lead time despite the improvement in their overall takeover performances with increased lead time.
CONCLUSIONS


This study found an inverted U-shaped relationship between the drivers' workload generated by NDRTs and takeover performance. The moderate workload level (rather than the lower or higher workload level) led to a faster and better takeover performance, and it seemed to require minimal lead time for drivers. These findings help understand the relationship of drivers' workload during the automation and takeover performance in conditional automated driving. An important recommendation emerging from this work is to investigate what should be the most efficient method to detect the drivers' workload state real-time and give feedback to them when it comes to overload or underload during the automated driving.",2020,"The moderate workload level (rather than the lower or higher workload level) led to a faster and better takeover performance, and it seemed to require minimal lead time for drivers.",['Fifty drivers'],[],"['shorter takeover times and better takeover quality', 'moderate workload level']","[{'cui': 'C0684312', 'cui_str': 'Vehicle driver'}]",[],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",50.0,0.0299729,"The moderate workload level (rather than the lower or higher workload level) led to a faster and better takeover performance, and it seemed to require minimal lead time for drivers.","[{'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}, {'ForeName': 'Changxu', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Chai', 'Affiliation': 'State Key Lab of CAD&CG, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jinlei', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}, {'ForeName': 'Hongting', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Psychology, Zhejiang Sci-Tech University, Hangzhou, China.'}]",Traffic injury prevention,['10.1080/15389588.2020.1804060']
2850,32822222,A Clinical Study on Microwave Ablation in Combination with Chemotherapy in Treating Peripheral IIIB-IV Nonsmall Cell Lung Cancer.,"Background:  This study investigated the efficacy and complications of microwave ablation in combination with chemotherapy in treating peripheral IIIB-IV nonsmall cell lung cancer (NSCLC).  Materials and Methods:  A total of 100 patients with peripheral IIIB-IV NSCLC were randomly divided into two groups: combination group ( n  = 52) and chemotherapy group ( n  = 48). Patients in the combination group were treated with microwave ablation, radiotherapy, and chemotherapy, whereas the patients in the chemotherapy group were treated with pemetrexed disodium or gemcitabine hydrochloride, cisplatin chemotherapy, and conventional radiotherapy.  Results:  The effectiveness and disease control rates were significantly higher in the combination group than in the chemotherapy group ( p  < 0.05). The second- and third-year survival rates were significantly higher in the combination group than in the chemotherapy group ( p  < 0.05). However, patients in the combination group had no serious complications, and there were no intraoperative and perioperative deaths.  Conclusions:  Microwave ablation is safe and effective. Combination chemotherapy is superior to chemotherapy in treating peripheral IIIB-IV NSCLC in terms of effectiveness rate, disease control rate, and extended patient survival time.",2020,"Combination chemotherapy is superior to chemotherapy in treating peripheral IIIB-IV NSCLC in terms of effectiveness rate, disease control rate, and extended patient survival time.",['100 patients with peripheral IIIB-IV NSCLC'],"['Combination chemotherapy', 'Microwave ablation', 'Microwave Ablation in Combination with Chemotherapy', 'pemetrexed disodium or gemcitabine hydrochloride, cisplatin chemotherapy, and conventional radiotherapy', 'microwave ablation, radiotherapy, and chemotherapy', 'microwave ablation in combination with chemotherapy', 'chemotherapy']","['serious complications', 'second- and third-year survival rates', 'effectiveness rate, disease control rate, and extended patient survival time', 'intraoperative and perioperative deaths', 'effectiveness and disease control rates']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C3854551', 'cui_str': 'Microwave ablation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0771488', 'cui_str': 'Gemcitabine hydrochloride'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C1301895', 'cui_str': 'Perioperative death'}]",100.0,0.0252253,"Combination chemotherapy is superior to chemotherapy in treating peripheral IIIB-IV NSCLC in terms of effectiveness rate, disease control rate, and extended patient survival time.","[{'ForeName': 'Ying-Qing', 'Initials': 'YQ', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory, Affiliated Hospital of Jiaxing University, Jiaxing Key Laboratory of Precision Treatment for Lung Cancer, Jiaxing, China.'}, {'ForeName': 'Yong-Lei', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': 'Department of Respiratory, Affiliated Hospital of Jiaxing University, Jiaxing Key Laboratory of Precision Treatment for Lung Cancer, Jiaxing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Respiratory, Affiliated Hospital of Jiaxing University, Jiaxing Key Laboratory of Precision Treatment for Lung Cancer, Jiaxing, China.'}, {'ForeName': 'Ying-Xin', 'Initials': 'YX', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory, Affiliated Hospital of Jiaxing University, Jiaxing Key Laboratory of Precision Treatment for Lung Cancer, Jiaxing, China.'}]",Cancer biotherapy & radiopharmaceuticals,['10.1089/cbr.2020.3859']
2851,32822260,"Cognitive effects of acute aerobic exercise: Exploring the influence of exercise duration, exhaustion, task complexity and expectancies in endurance-trained individuals.","The cognitive effects of acute aerobic exercise were investigated in endurance-trained individuals. On two occasions, 21 cyclists; 11 male (VO 2max : 57 ± 9 mL·kg -1 ·min -1 ) and 10 female (VO 2max : 51 ± 9 mL·kg -1 ·min -1 ), completed 45 min of fixed, moderate-intensity (discontinuous) cycling followed by an incremental ride to exhaustion. Cognitive function was assessed at Baseline, after 15 and 45 min of exercise (15EX and 45EX) and at Exhaustion using a 4-Choice Reaction Time (CRT) test and the Stroop test (Incongruent and Congruent Reaction Time [RT]). A sham capsule was administered on one occasion to determine whether the cognitive response to exercise was robust to the influence of a placebo. CRT, Congruent RT and Incongruent RT decreased (improved) at 15EX, 45EX and Exhaustion compared to Baseline ( p 's<0.005). While CRT and Congruent RT were faster at 45EX than 15EX ( p 's<0.020), Incongruent RT was not ( p = 1.000). The sham treatment did not affect cognition. When performed at a moderate-intensity, longer duration exercise (up to 45 min) may improve cognition to a greater extent than shorter duration exercise; however, the magnitude of improvement appears to decrease with increasing task complexity. HI/EE performed following a sustained bout of dehydrating activity may not impair cognition.",2020,"While CRT and Congruent RT were faster at 45EX than 15EX ( p 's<0.020), Incongruent RT was not ( p = 1.000).","['endurance-trained individuals', '21 cyclists; 11 male (VO 2max : 57\xa0±\xa09 mL·kg -1 ·min -1 ) and 10 female (VO 2max : 51\xa0±']","['placebo', 'acute aerobic exercise', '9 mL·kg -1 ·min -1 ), completed 45\xa0min of fixed, moderate-intensity (discontinuous) cycling followed by an incremental ride to exhaustion']","['Cognitive function', 'CRT, Congruent RT and Incongruent RT decreased (improved) at 15EX, 45EX and Exhaustion', 'exercise duration, exhaustion, task complexity and expectancies']","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0868930', 'cui_str': 'Cathode Ray Tubes'}, {'cui': 'C0439853', 'cui_str': 'Congruent'}, {'cui': 'C1321310', 'cui_str': 'Incongruous'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}]",,0.0758166,"While CRT and Congruent RT were faster at 45EX than 15EX ( p 's<0.020), Incongruent RT was not ( p = 1.000).","[{'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McCartney', 'Affiliation': 'Faculty of Science, School of Psychology, University of Sydney , Sydney, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Desbrow', 'Affiliation': 'School of Allied Health Sciences, Griffith University , Gold Coast, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Irwin', 'Affiliation': 'School of Allied Health Sciences, Griffith University , Gold Coast, Australia.'}]",Journal of sports sciences,['10.1080/02640414.2020.1809976']
2852,32822275,Randomized Phase II Trial of Nivolumab With Stereotactic Body Radiotherapy Versus Nivolumab Alone in Metastatic Head and Neck Squamous Cell Carcinoma.,"PURPOSE


The objective response rate (ORR) for single-agent anti-programmed death receptor 1 (anti-PD-1) therapy is modest in patients with metastatic or recurrent head and neck squamous cell carcinoma (HNSCC). We aimed to test whether radiotherapy may act synergistically with anti-PD-1 therapy to improve response through the abscopal effect.
PATIENTS AND METHODS


We conducted a single-center, randomized, phase II trial of nivolumab (anti-PD-1 therapy) versus nivolumab plus stereotactic body radiotherapy (SBRT) in patients with metastatic HNSCC. Patients had at least two metastatic lesions: one that could be safely irradiated and one measurable by RECIST version 1.1. Patients were randomly assigned (1:1), stratified by human papillomavirus status, to nivolumab (3 mg/kg intravenously every 2 weeks) or nivolumab (same dose) plus SBRT (9 Gy × 3) to 1 lesion. The primary end point was ORR in nonirradiated lesions, which was assessed by RECIST in patients with at least one available set of on-treatment images; safety was assessed in a per-protocol population.
RESULTS


Between March 11, 2016, and June 22, 2018, 62 patients were randomly assigned to nivolumab (n = 30) or nivolumab plus SBRT (n = 32). There was no statistically significant ORR difference between arms (34.5% [95% CI, 19.9% to 52.7%]  v  29.0% [95% CI, 16.1% to 46.6%];  P  = .86). There was no significant difference in overall survival ( P  = .75), progression-free survival ( P  = .79), or response duration ( P  = .26). Grade 3-5 toxicities were similar (13.3%  v  9.7%;  P  = .70).
CONCLUSION


We found no improvement in response and no evidence of an abscopal effect with the addition of SBRT to nivolumab in unselected patients with metastatic HNSCC.",2020,"Grade 3-5 toxicities were similar (13.3%  v  9.7%;  P  = .70).
","['Patients had at least two metastatic lesions', '62 patients', 'patients with metastatic or recurrent head and neck squamous cell carcinoma (HNSCC', 'unselected patients with metastatic HNSCC', 'patients with metastatic HNSCC', 'Metastatic Head and Neck Squamous Cell Carcinoma', 'Between March 11, 2016, and June 22, 2018']","['radiotherapy', 'nivolumab plus SBRT', 'Nivolumab With Stereotactic Body Radiotherapy Versus Nivolumab Alone', 'nivolumab (anti-PD-1 therapy', 'nivolumab', 'nivolumab (3 mg/kg intravenously every 2 weeks) or nivolumab (same dose) plus SBRT', 'nivolumab plus stereotactic body radiotherapy (SBRT', 'single-agent anti-programmed death receptor 1 (anti-PD-1) therapy']","['Grade 3-5 toxicities', 'objective response rate (ORR', 'progression-free survival', 'overall survival', 'ORR in nonirradiated lesions', 'response duration', 'ORR difference']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0744620', 'cui_str': 'Squamous cell carcinoma of head and neck metastatic'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1720823', 'cui_str': 'Stereotactic Body Radiotherapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720947', 'cui_str': 'Death Domain Receptors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",62.0,0.154996,"Grade 3-5 toxicities were similar (13.3%  v  9.7%;  P  = .70).
","[{'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'McBride', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Sherman', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'C Jillian', 'Initials': 'CJ', 'LastName': 'Tsai', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Shrujal', 'Initials': 'S', 'LastName': 'Baxi', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jahan', 'Initials': 'J', 'LastName': 'Aghalar', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Eng', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Wanqing Iris', 'Initials': 'WI', 'LastName': 'Zhi', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'McFarland', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Loren Scott', 'Initials': 'LS', 'LastName': 'Michel', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Young', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lefkowitz', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Spielsinger', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Flynn', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Dunn', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Ho', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Riaz', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pfister', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Lee', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00290']
2853,32822286,"MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum.","PURPOSE


Low-grade serous ovarian carcinomas (LGSOCs) have historically low chemotherapy responses. Alterations affecting the MAPK pathway, most commonly KRAS/BRAF, are present in 30%-60% of LGSOCs. The purpose of this study was to evaluate binimetinib, a potent MEK1/2 inhibitor with demonstrated activity across multiple cancers, in LGSOC.
METHODS


This was a 2:1 randomized study of binimetinib (45 mg twice daily) versus physician's choice chemotherapy (PCC). Eligible patients had recurrent measurable LGSOC after ≥ 1 prior platinum-based chemotherapy but ≤ 3 prior chemotherapy lines. The primary end point was progression-free survival (PFS) by blinded independent central review (BICR); additional assessments included overall survival (OS), overall response rate (ORR), duration of response (DOR), clinical-benefit rate, biomarkers, and safety.
RESULTS


A total of 303 patients were randomly assigned to an arm of the study at the time of interim analysis (January 20, 2016). Median PFS by BICR was 9.1 months (95% CI, 7.3 to 11.3) for binimetinib and 10.6 months (95% CI, 9.2 to 14.5) for PCC (hazard ratio,1.21; 95%CI, 0.79 to 1.86), resulting in early study closure according to a prespecified futility boundary after 341 patients had enrolled. Secondary efficacy end points were similar in the two groups: ORR 16% (complete response [CR]/partial responses[PRs], 32) versus 13% (CR/PRs, 13); median DOR, 8.1 months (range, 0.03 to ≥ 12.0 months) versus 6.7 months (0.03 to ≥ 9.7 months); and median OS, 25.3 versus 20.8 months for binimetinib and PCC, respectively. Safety results were consistent with the known safety profile of binimetinib; the most common grade ≥ 3 event was increased blood creatine kinase level (26%). Post hoc analysis suggests a possible association between  KRAS  mutation and response to binimetinib. Results from an updated analysis (n = 341; January 2019) were consistent.
CONCLUSION


Although the MEK Inhibitor in Low-Grade Serous Ovarian Cancer Study did not meet its primary end point, binimetinib showed activity in LGSOC across the efficacy end points evaluated. A higher response to chemotherapy than expected was observed and  KRAS  mutation might predict response to binimetinib.",2020,"Median PFS by BICR was 9.1 months (95% CI, 7.3 to 11.3) for binimetinib and 10.6 months (95% CI, 9.2 to 14.5) for PCC (hazard ratio,1.21; 95%CI, 0.79 to 1.86), resulting in early study closure according to a prespecified futility boundary after 341 patients had enrolled.","['Eligible patients had recurrent measurable LGSOC after ≥ 1 prior platinum-based chemotherapy but ≤ 3 prior chemotherapy lines', '341 patients had enrolled', '303 patients']","[""Binimetinib Versus Physician's Choice Chemotherapy"", ""binimetinib (45 mg twice daily) versus physician's choice chemotherapy (PCC""]","['progression-free survival (PFS) by blinded independent central review (BICR); additional assessments included overall survival (OS), overall response rate (ORR), duration of response (DOR), clinical-benefit rate, biomarkers, and safety', 'blood creatine kinase level', 'Median PFS by BICR']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3899947', 'cui_str': 'Binimetinib'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0853178', 'cui_str': 'Blood creatine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",303.0,0.201088,"Median PFS by BICR was 9.1 months (95% CI, 7.3 to 11.3) for binimetinib and 10.6 months (95% CI, 9.2 to 14.5) for PCC (hazard ratio,1.21; 95%CI, 0.79 to 1.86), resulting in early study closure according to a prespecified futility boundary after 341 patients had enrolled.","[{'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ.'}, {'ForeName': 'Rachel N', 'Initials': 'RN', 'LastName': 'Grisham', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Weill Cornell Medical Center, New York, NY.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Royal Marsden National Health Service Foundation Trust and Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Kalbacher', 'Affiliation': 'Centre Hospitalier Régional et Universitaire de Besançon, CHRU de Besançon, Besançon, France.'}, {'ForeName': 'Mansoor Raza', 'Initials': 'MR', 'LastName': 'Mirza', 'Affiliation': 'Nordic Society of Gynaecological Oncology and Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Romero', 'Affiliation': 'Servicio de Oncologıa Medica, Fundacion Instituto Valenciano de Oncologıa, Valencia, Spain.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vuylsteke', 'Affiliation': 'CHU Université catholique de Louvain Namur, Sainte-Elisabeth, Namur, Belgium.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Hilpert', 'Affiliation': 'Onkologisches Therapiezentrum am Krankenhaus Jerusalem, Hamburg, Germany.'}, {'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Anneke', 'Initials': 'A', 'LastName': 'Westermann', 'Affiliation': 'Dutch Gynaecological Oncology Group, Amsterdam University Medical Centers, Amsterdam, the Netherlands.'}, {'ForeName': 'Martin K', 'Initials': 'MK', 'LastName': 'Oehler', 'Affiliation': 'Department of Gynaecological Oncology, Royal Adelaide Hospital, Adelaide, South Australia 5005, Australia.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Pignata', 'Affiliation': 'Istituto Nazionale Tumori Fondazione Pascale IRCCS, Naples, Italy.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix, AZ.'}, {'ForeName': 'Nicoletta', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Dipartimento Medicina e Chirurgia, Università Milano-Bicocca, Programma Ginecologia Oncologica Istituto Europeo Oncologia, IRCCS, Milan, Italy.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Drill', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Weill Cornell Medical Center, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cibula', 'Affiliation': 'First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic.'}, {'ForeName': 'Kathleen N', 'Initials': 'KN', 'LastName': 'Moore', 'Affiliation': 'Stephenson Cancer Center at The University of Oklahoma Health Sciences Center, Oklahoma City, OK.'}, {'ForeName': 'Janna', 'Initials': 'J', 'LastName': 'Christy-Bittel', 'Affiliation': 'Pfizer, New York, NY.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Del Campo', 'Affiliation': ""Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Berger', 'Affiliation': 'University Clinic for Gynaecology and Obstetrics, Medical University of Innsbruck, Innsbruck 6020, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Marth', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Innsbruck, Austrian AGO, Innsbruck, Austria.'}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'Center for Oncological Surgery, European Competence Center for Ovarian Cancer Campus Virchow Klinikum and Benjamin Franklin Charité Comprehensive Cancer Center\u2009, Medical University of Berlin, Berlin, Germany.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Churruca', 'Affiliation': 'Biodonostia HRI, Osasun Ikerketa Insitutua, Insituto de Investigacion Sanitaria, San Sebastián, Gipuzkoa, Spain.'}, {'ForeName': 'Adam P', 'Initials': 'AP', 'LastName': 'Boyd', 'Affiliation': 'Pfizer, New York, NY.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Kristensen', 'Affiliation': 'Department for Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Clamp', 'Affiliation': 'Department of Medical Oncology, The Christie National Health Service Foundation Trust, and University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'Centre Léon Bérard, Netsarc Network, Université Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'Ignace', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'Belgium and Luxemburg Gynaecological Oncology Group, University Hospitals Leuven, Leuven, Belgium.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01164']
2854,32822287,"Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: Updated Results of ALTERNATIVE.","PURPOSE


Human epidermal growth factor receptor 2 (HER2) targeting plus endocrine therapy (ET) improved clinical benefit in HER2-positive, hormone receptor (HR)-positive metastatic breast cancer (MBC) versus ET alone. Dual HER2 blockade enhances clinical benefit versus single HER2 blockade. The ALTERNATIVE study evaluated the efficacy and safety of dual HER2 blockade plus aromatase inhibitor (AI) in postmenopausal women with HER2-positive/HR-positive MBC who received prior ET and prior neo(adjuvant)/first-line trastuzumab (TRAS) plus chemotherapy. This updated article reflects minor numerical corrections in some secondary efficacy analyses that resulted from programming errors and that do not change the major conclusions of the study.
METHODS


Patients were randomly assigned (1:1:1) to receive lapatinib (LAP) plus TRAS plus AI, TRAS plus AI, or LAP plus AI. Patients for whom chemotherapy was intended were excluded. The primary end point was progression-free survival (PFS; investigator assessed) with LAP plus TRAS plus AI versus TRAS plus AI. Secondary end points were PFS (comparison of other arms), overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR), and safety.
RESULTS


Three hundred fifty-five patients were included in this analysis: LAP plus TRAS plus AI (n = 120), TRAS plus AI (n = 117), and LAP plus AI (n = 118). Baseline characteristics were balanced. The study met its primary end point; superior PFS was observed with LAP plus TRAS plus AI versus TRAS plus AI (median PFS, 11  v  5.6 months; hazard ratio, 0.62 [95% CI, 0.45 to 0.88];  P  = .0063). A consistent PFS benefit was observed in predefined subgroups. ORR, CBR, and OS also favored LAP plus TRAS plus AI. The median PFS with LAP plus AI versus TRAS plus AI was 8.3 versus 5.6 months (hazard ratio, 0.85 [95% CI, 0.62 to 1.17];  P  = .3159). Common adverse events (AEs; ≥ 15%) with LAP plus TRAS plus AI, TRAS plus AI, and LAP plus AI were diarrhea (69%, 9%, and 51%, respectively), rash (36%, 2%, and 28%, respectively), nausea (22%, 9%, and 22%, respectively), and paronychia (30%, 0%, and 15%, respectively), mostly grade 1 or 2. Serious AEs were reported similarly across the 3 groups, and AEs leading to discontinuation were lower with LAP plus TRAS plus AI.
CONCLUSION


Dual HER2 blockade with LAP plus TRAS plus AI showed superior PFS benefit versus TRAS plus AI in patients with HER2-positive/HR-positive MBC. This combination offers an effective and safe chemotherapy-sparing alternative treatment regimen for this patient population.",2020,"Serious AEs were reported similarly across the 3 groups, and AEs leading to discontinuation were lower with LAP plus TRAS plus AI.
","['Postmenopausal Women', 'patients with HER2-positive/HR-positive MBC', 'Patients', 'Three hundred fifty-five patients were included in this analysis', 'postmenopausal women with HER2-positive/HR-positive MBC who received prior']","['Dual Human Epidermal Growth Factor Receptor 2 (HER2', 'endocrine therapy (ET', 'Blockade With Lapatinib Plus Trastuzumab', 'dual HER2 blockade plus aromatase inhibitor (AI', 'Dual HER2 blockade', 'ET and prior neo(adjuvant)/first-line trastuzumab (TRAS) plus chemotherapy', 'lapatinib (LAP) plus TRAS plus AI, TRAS plus AI, or LAP plus AI', 'LAP plus TRAS plus AI']","['diarrhea', 'paronychia', 'ORR, CBR, and OS', 'progression-free survival', 'PFS benefit', 'PFS (comparison of other arms), overall survival (OS), overall response rate (ORR), clinical benefit rate (CBR), and safety', 'rash', 'nausea', 'median PFS']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0450382', 'cui_str': '55'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0030578', 'cui_str': 'Paronychia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",355.0,0.0923443,"Serious AEs were reported similarly across the 3 groups, and AEs leading to discontinuation were lower with LAP plus TRAS plus AI.
","[{'ForeName': 'Stephen R D', 'Initials': 'SRD', 'LastName': 'Johnston', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Hegg', 'Affiliation': 'Centro de Referência da Saúde da Mulher, São Paulo, Brazil.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.'}, {'ForeName': 'In Hae', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': 'National Cancer Center, Gyeonggi-do, Korea.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Burdaeva', 'Affiliation': 'Regional Oncology Dispensary, Arkhangelsk, Russia.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Kurteva', 'Affiliation': 'University Cancer Center Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Press', 'Affiliation': 'University of Southern California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Sergei', 'Initials': 'S', 'LastName': 'Tjulandin', 'Affiliation': 'N.N. Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Aichi Cancer Center Hospital, Aichi, Japan.'}, {'ForeName': 'Sergio D', 'Initials': 'SD', 'LastName': 'Simon', 'Affiliation': 'Hospital Israelita Albert Einstein, São Paulo, Brazil.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kenny', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Severine', 'Initials': 'S', 'LastName': 'Sarp', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Izquierdo', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Lisa S', 'Initials': 'LS', 'LastName': 'Williams', 'Affiliation': 'Novartis Pharmaceuticals UK Limited, Frimley, United Kingdom.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Gradishar', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01894']
2855,32822347,Safety and parasite clearance of artemisinin-resistant Plasmodium falciparum infection: A pilot and a randomised volunteer infection study in Australia.,"BACKGROUND


Artemisinin resistance is threatening malaria control. We aimed to develop and test a human model of artemisinin-resistant (ART-R) Plasmodium falciparum to evaluate the efficacy of drugs against ART-R malaria.
METHODS AND FINDINGS


We conducted 2 sequential phase 1, single-centre, open-label clinical trials at Q-Pharm, Brisbane, Australia, using the induced blood-stage malaria (IBSM) model, whereby healthy participants are intravenously inoculated with blood-stage parasites. In a pilot study, participants were inoculated (Day 0) with approximately 2,800 viable P. falciparum ART-R parasites. In a comparative study, participants were randomised to receive approximately 2,800 viable P. falciparum ART-R (Day 0) or artemisinin-sensitive (ART-S) parasites (Day 1). In both studies, participants were administered a single approximately 2 mg/kg oral dose of artesunate (AS; Day 9). Primary outcomes were safety, ART-R parasite infectivity, and parasite clearance. In the pilot study, 2 participants were enrolled between April 27, 2017, and September 12, 2017, and included in final analyses (males n = 2 [100%], mean age = 26 years [range, 23-28 years]). In the comparative study, 25 participants were enrolled between October 26, 2017, and October 18, 2018, of whom 22 were inoculated and included in final analyses (ART-R infected participants: males n = 7 [53.8%], median age = 22 years [range, 18-40 years]; ART-S infected participants: males n = 5 [55.6%], median age = 28 years [range, 22-35 years]). In both studies, all participants inoculated with ART-R parasites became parasitaemic. A total of 36 adverse events were reported in the pilot study and 277 in the comparative study. Common adverse events in both studies included headache, pyrexia, myalgia, nausea, and chills; none were serious. Seven participants experienced transient severe falls in white cell counts and/or elevations in liver transaminase levels which were considered related to malaria. Additionally, 2 participants developed ventricular extrasystoles that were attributed to unmasking of a predisposition to benign fever-induced tachyarrhythmia. In the comparative study, parasite clearance half-life after AS was significantly longer for ART-R infected participants (n = 13, 6.5 hours; 95% confidence interval [CI] 6.3-6.7 hours) compared with ART-S infected participants (n = 9, 3.2 hours; 95% CI 3.0-3.3 hours; p < 0.001). The main limitation of this study was that the ART-R and ART-S parasite strains did not share the same genetic background.
CONCLUSIONS


We developed the first (to our knowledge) human model of ART-R malaria. The delayed clearance profile of ART-R parasites after AS aligns with field study observations. Although based on a relatively small sample size, results indicate that this model can be safely used to assess new drugs against ART-R P. falciparum.
TRIAL REGISTRATION


The studies were registered with the Australian New Zealand Clinical Trials Registry: ACTRN12617000244303 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372357) and ACTRN12617001394336 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373637).",2020,"Common adverse events in both studies included headache, pyrexia, myalgia, nausea, and chills; none were serious.","['healthy participants are intravenously inoculated with blood-stage parasites', '25 participants were enrolled between October 26, 2017, and October 18, 2018, of whom 22 were inoculated and included in final analyses (ART-R infected participants: males n = 7 [53.8%], median age = 22 years [range, 18-40 years]; ART-S infected participants: males n = 5 [55.6%], median age = 28 years [range, 22-35 years', 'participants were inoculated (Day 0) with approximately 2,800 viable P. falciparum ART-R parasites', 'volunteer infection study in Australia', '2 participants were enrolled between April 27, 2017, and September 12, 2017, and included in final analyses (males n = 2 [100%], mean age = 26 years [range, 23-28 years']","['receive approximately 2,800 viable P. falciparum ART-R (Day 0) or artemisinin-sensitive (ART-S) parasites (Day 1', 'artemisinin-resistant Plasmodium falciparum infection']","['ventricular extrasystoles', 'delayed clearance profile of ART-R parasites', 'headache, pyrexia, myalgia, nausea, and chills', 'safety, ART-R parasite infectivity, and parasite clearance', 'liver transaminase levels', 'transient severe falls']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0858318', 'cui_str': 'Plasmodium falciparum infection'}]","[{'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030657', 'cui_str': 'pathogenicity'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",2.0,0.271382,"Common adverse events in both studies included headache, pyrexia, myalgia, nausea, and chills; none were serious.","[{'ForeName': 'Rebecca E', 'Initials': 'RE', 'LastName': 'Watts', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Odedra', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Marquart', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Lachlan', 'Initials': 'L', 'LastName': 'Webb', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Azrin N', 'Initials': 'AN', 'LastName': 'Abd-Rahman', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cascales', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Chalon', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rebelo', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Zuleima', 'Initials': 'Z', 'LastName': 'Pava', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Katharine A', 'Initials': 'KA', 'LastName': 'Collins', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Cielo', 'Initials': 'C', 'LastName': 'Pasay', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Nanhua', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'Australian Army Malaria Institute, Brisbane, Australia.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Peatey', 'Affiliation': 'Australian Army Malaria Institute, Brisbane, Australia.'}, {'ForeName': 'Jörg J', 'Initials': 'JJ', 'LastName': 'Möhrle', 'Affiliation': 'Medicines for Malaria Venture, Geneva, Switzerland.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'McCarthy', 'Affiliation': 'QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003203']
2856,32822361,The effects of whole-body electromyostimulation (WB-EMS) in comparison to a multimodal treatment concept in patients with non-specific chronic back pain-A prospective clinical intervention study.,"BACKGROUND


According to present guidelines, active exercise is one key component in the comprehensive treatment of nonspecific chronic back pain (NSCBP). Whole body electromyostimulation (WB-EMS) is a safe, and time-effective training method, that may be effective in NSCBP-patients.
METHODS


In this prospective and controlled nonrandomized clinical study, two therapeutic approaches were compared. One group received 20 minutes WB-EMS per week. An active control group (ACG) received a multimodal therapy program. A third group included subjects without back pain. To all groups, the following measurement instruments were applied: Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), North American Spine Society Instrument (NASS); SF 36 survey and measurements for muscular function and postural stability. In the EMS-group: T0: baseline; T1: at 6 weeks; T2: at 12 weeks and T3: at 24 weeks. In the ACG: T0 baseline and T1 after 4 weeks.
RESULTS


In the intervention group, 128 patients with low back pain were enrolled, 85 in the WB-EMS group and 43 in the ACG. 34 subjects were allocated to the passive control group. The average age was 58.6 years (18-86 years). In the EMS group, the NRS (1-10) improved statistically and clinically significantly by 2 points. The ODI was reduced by 19.7 points. The NASS and most of the SF 36 items improved significantly. In the multimodal treatment group, only the muscular function improved slightly.
CONCLUSION


Our data support the hypothesis that WB-EMS is at least as effective as a multimodal treatment, which is often referred to as being the golden standard. Therefore WB-EMS may be an effective and, with 20 min./week training time, very time-efficient alternative to established multimodal treatment models.",2020,The NASS and most of the SF 36 items improved significantly.,"['The average age was 58.6 years (18-86 years', 'patients with non-specific chronic back pain', '128 patients with low back pain were enrolled, 85 in the WB-EMS group and 43 in the ACG', '34 subjects']","['Whole body electromyostimulation (WB-EMS', 'whole-body electromyostimulation (WB-EMS', 'multimodal therapy program']","['muscular function improved slightly', 'subjects without back pain', 'ODI', 'Numeric Rating Scale (NRS), Oswestry Disability Index (ODI), North American Spine Society Instrument (NASS); SF 36 survey and measurements for muscular function and postural stability']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0740418', 'cui_str': 'Chronic back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0750482', 'cui_str': 'Slightly'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0425358', 'cui_str': 'North American origin'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",128.0,0.022024,The NASS and most of the SF 36 items improved significantly.,"[{'ForeName': 'Karl Lorenz', 'Initials': 'KL', 'LastName': 'Konrad', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Baeyens', 'Affiliation': 'Department of Physiotherapy, Human Physiology and Anatomy, Vrije Universiteit Brussel (VUB), Brussel, Belgium.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Birkenmaier', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Anna Helena', 'Initials': 'AH', 'LastName': 'Ranker', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Widmann', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Leukert', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Wenisch', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Kraft', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Jansson', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wegener', 'Affiliation': 'Department of Orthopaedic Surgery, Physical Medicine and Rehabilitation, Ludwig-Maximilians- University Munich (LMU), Munich, Germany.'}]",PloS one,['10.1371/journal.pone.0236780']
2857,32822614,"Efficacy and safety of sildenafil added to pirfenidone in patients with advanced idiopathic pulmonary fibrosis and risk of pulmonary hypertension: a double-blind, randomised, placebo-controlled, phase 2b trial.","BACKGROUND


The benefit of sildenafil in patients with advanced idiopathic pulmonary fibrosis (IPF) at risk of poor outcomes from pulmonary hypertension, whether already present or likely to develop, is uncertain. We aimed to assess the efficacy and safety of sildenafil added to pirfenidone versus placebo added to pirfenidone for 52 weeks in patients with advanced IPF and at risk of group 3 pulmonary hypertension.
METHODS


We did a multicentre, international, double-blind, randomised, placebo-controlled, phase 2b study at 56 university clinics, research hospitals, and tertiary sites in Canada, Europe (Belgium, Czech Republic, Germany, Greece, Hungary, Italy, the Netherlands, Spain, and Turkey), Israel, and Africa (Egypt and South Africa). Eligible patients (aged 40-80 years) had advanced IPF (carbon monoxide diffusing capacity ≤40% predicted at screening), and were at risk of group 3 pulmonary hypertension (mean pulmonary artery pressure of ≥20 mm Hg with pulmonary artery wedge pressure of ≤15 mm Hg on previous right-heart catheterisation, or intermediate or high probability of group 3 pulmonary hypertension on echocardiography as defined by the 2015 European Society of Cardiology and European Respiratory Society guidelines). Patients were randomly assigned 1:1 to oral sildenafil tablets (20 mg three times daily) or placebo, both in addition to oral pirfenidone capsules (801 mg three times daily), using a validated interactive voice-based or web-based response system with permuted block randomisation, stratified by previous right-heart catheterisation (yes or no) and forced expiratory volume in 1 s to forced vital capacity ratio (<0·8 or ≥0·8). The composite primary endpoint was disease progression, defined as either a relevant decline in 6-min walk distance, respiratory-related admission to hospital, or all-cause mortality, after 52 weeks and was assessed in the intention-to-treat population; safety was assessed in all patients who received at least one dose of the study drug. This trial is registered with ClinicalTrials.gov, NCT02951429, and is no longer recruiting. The 11-month safety follow-up is ongoing.
FINDINGS


Between Jan 13, 2017, and Aug 30, 2018, 247 patients were screened for eligibility, 177 of whom were randomly assigned to a treatment group (n=88 sildenafil; n=89 placebo) and were assessed for the primary outcome. There was no difference in the proportion of patients with disease progression over 52 weeks between the sildenafil (64 [73%] of 88 patients) and placebo groups (62 [70%] of 89 patients; between-group difference 3·06% [95% CI -11·30 to 17·97]; p=0·65). Serious treatment-emergent adverse events were reported in 54 (61%) patients in the sildenafil group and 55 (62%) patients in the placebo group. Treatment-emergent adverse events leading to mortality occurred in 22 (25%) patients in the sildenafil group and 26 (29%) in the placebo group.
INTERPRETATION


Addition of sildenafil to pirfenidone did not provide a treatment benefit versus pirfenidone plus placebo up to 52 weeks in patients with advanced IPF and risk of pulmonary hypertension. No new safety signals were identified with either treatment. Although the absence of a beneficial treatment effect suggests that sildenafil is not an appropriate treatment in the overall population, further research is required to establish if specific subgroups of patients with IPF might benefit from sildenafil.
FUNDING


F Hoffmann-La Roche.",2020,Serious treatment-emergent adverse events were reported in 54 (61%) patients in the sildenafil group and 55 (62%) patients in the placebo group.,"['patients with advanced IPF and at risk of group 3 pulmonary hypertension', 'patients with advanced IPF and risk of pulmonary hypertension', 'patients with advanced idiopathic pulmonary fibrosis (IPF', '247 patients were screened for eligibility, 177 of whom were randomly assigned to a treatment group (n=88', 'Between Jan 13, 2017, and Aug 30, 2018', 'patients with advanced idiopathic pulmonary fibrosis and risk of pulmonary hypertension', '56 university clinics, research hospitals, and tertiary sites in Canada, Europe (Belgium, Czech Republic, Germany, Greece, Hungary, Italy, the Netherlands, Spain, and Turkey), Israel, and Africa (Egypt and South Africa', 'Eligible patients (aged 40-80 years) had advanced IPF (carbon monoxide diffusing capacity ≤40% predicted at screening), and were at risk of group 3 pulmonary hypertension (mean pulmonary artery pressure of ≥20 mm Hg with pulmonary artery wedge pressure of ≤15 mm Hg on previous right-heart catheterisation, or intermediate or high probability of group 3 pulmonary hypertension on echocardiography as defined by the 2015 European Society of Cardiology and European Respiratory Society guidelines']","['pirfenidone', 'sildenafil', 'sildenafil; n=89 placebo', 'placebo, both in addition to oral pirfenidone capsules', 'validated interactive voice-based or web-based response system with permuted block randomisation, stratified by previous right-heart catheterisation (yes or no) and forced expiratory volume in 1 s to forced vital capacity ratio', 'pirfenidone plus placebo', 'pirfenidone versus placebo', 'oral sildenafil tablets', 'placebo']","['disease progression, defined as either a relevant decline in 6-min walk distance, respiratory-related admission to hospital, or all-cause mortality', 'intention-to-treat population; safety', 'Efficacy and safety', 'efficacy and safety', 'mortality', 'Serious treatment-emergent adverse events', 'proportion of patients with disease progression']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1800706', 'cui_str': 'Idiopathic pulmonary fibrosis'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0206578', 'cui_str': 'Czech republic'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0013715', 'cui_str': 'Egypt'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199525', 'cui_str': 'Carbon monoxide diffusing capacity measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure'}, {'cui': 'C0034094', 'cui_str': 'Pulmonary artery wedge pressure'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0189896', 'cui_str': 'Catheterization of right heart'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0007189', 'cui_str': 'Cardiology'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0189896', 'cui_str': 'Catheterization of right heart'}, {'cui': 'C1298907', 'cui_str': 'Yes'}, {'cui': 'C1298908', 'cui_str': 'No'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1247941', 'cui_str': 'sildenafil Oral Tablet'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",247.0,0.6522,Serious treatment-emergent adverse events were reported in 54 (61%) patients in the sildenafil group and 55 (62%) patients in the placebo group.,"[{'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Behr', 'Affiliation': 'Department of Internal Medicine V, University of Munich Ludwig-Maximilians-Universität, Munich, Germany; Lungenforschungsambulanz Helmholtz Zentrum Munich, Comprehensive Pneumology Center, Munich, Germany. Electronic address: juergen.behr@med.uni-muenchen.de.'}, {'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Nathan', 'Affiliation': 'Advanced Lung Disease and Transplant Program, Inova Fairfax Hospital, Falls Church, VA, USA.'}, {'ForeName': 'Wim A', 'Initials': 'WA', 'LastName': 'Wuyts', 'Affiliation': 'Department of Pulmonary Medicine, Unit for Interstitial Lung Diseases, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Nesrin', 'Initials': 'N', 'LastName': 'Mogulkoc Bishop', 'Affiliation': 'Department of Pulmonary Medicine, Unit for Interstitial Lung Diseases, Ege University Hospital, Izmir, Turkey.'}, {'ForeName': 'Demosthenes E', 'Initials': 'DE', 'LastName': 'Bouros', 'Affiliation': 'First Academic Department of Pneumonology, Interstitial Lung Disease Unit, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Antoniou', 'Affiliation': 'Department of Thoracic Medicine, University of Crete, Heraklion, Crete, Greece.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Guiot', 'Affiliation': 'Respiratory Department and GIGA I(3) Research Unit, Centre Hospitalier Universitaire de Liège, Liège, Belgium.'}, {'ForeName': 'Mordechai R', 'Initials': 'MR', 'LastName': 'Kramer', 'Affiliation': 'Pulmonary Institute, Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'Klaus-Uwe', 'Initials': 'KU', 'LastName': 'Kirchgaessler', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Bengus', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Gilberg', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Andras', 'Initials': 'A', 'LastName': 'Perjesi', 'Affiliation': 'F Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Harari', 'Affiliation': 'Department of Clinical Sciences and Community Health, University of Milan and Department of Medical Services, Ospedale San Giuseppe, MultiMedica IRCCS, Milan, Italy.'}, {'ForeName': 'Athol U', 'Initials': 'AU', 'LastName': 'Wells', 'Affiliation': 'Interstitial Lung Disease Unit, Royal Brompton Hospital, London, UK.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(20)30356-8']
2858,32822633,"Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial.","BACKGROUND


Atogepant is an orally administered, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist under investigation for treatment of migraine. We aimed to examine a range of oral doses for safety, tolerability, and efficacy for the preventive treatment of migraine.
METHODS


In this double-blind, phase 2b/3 trial, adults (aged 18-75 years), with a history (≥1 year) of migraine and 4-14 migraine days per month, were randomly assigned 2:1:2:2:1:1 (by means of a sequence generated by the statistical programming department of the sponsor, and operationalised through an automated interactive web-based response system) to receive placebo or atogepant 10 mg once daily, 30 mg once daily, 60 mg once daily, 30 mg twice daily, or 60 mg twice daily, in matching capsules. Participants, site personnel, and all study sponsor personnel were masked to treatment allocations. The study was done in 78 academic and private practice settings in the USA. The primary outcome was change from baseline in monthly migraine days across 12 weeks of treatment using a modified intention-to-treat approach. The overall type I error rate for multiple comparisons across active treatment doses was controlled at the 0·05 level by means of a graphic approach. The main outcomes to assess safety and tolerability were adverse event recordings. The trial is registered with ClinicalTrials.gov, NCT02848326 and is completed.
FINDINGS


Between Sept 6, 2016, and April 23, 2018, of 1772 individuals screened, 834 were randomly assigned and 825 received one dose or more of study medication: 186 received placebo, 93 atogepant 10 mg once daily, 183 atogepant 30 mg once daily, 186 atogepant 60 mg once daily, 86 atogepant 30 mg twice daily, and 91 atogepant 60 mg twice daily. Overall, 714 (87%) of 825 participants were female, 628 (76%) were white, median migraine duration was 17·5 years (IQR 10·0-28·0), and 232 (28%) had previously used preventive treatment. The primary efficacy analysis included 795 patients: 178 received placebo, 92 atogepant 10 mg once daily, 182 atogepant 30 mg once daily, 177 atogepant 60 mg once daily, 79 atogepant 30 mg twice daily, and 87 atogepant 60 mg twice daily. Across the 12-week treatment period, all five atogepant groups showed significant least-squares mean (SE) change from baseline in mean monthly migraine days versus placebo: atogepant 10 mg once daily -4·0 (0·3; p=0·024), 30 mg once daily -3·8 (0·2; p=0·039), 60 mg once daily -3·6 (0·2; p=0·039), 30 mg twice daily -4·2 (0·4; p=0·0034), and 60 mg twice daily -4·1 (0·3; p=0·0031); placebo -2·9 (0·2). The most common treatment-emergent adverse events (TEAEs) across all groups were nausea (range 5% [5/93] for 10 mg once daily to 12% [22/186] for 60 mg once daily vs 5% [9/186] for placebo) and fatigue (1% [1/93] for 10 mg once daily to 10% [9/91] for 60 mg twice daily vs 3% [6/186] for placebo). Treatment-related TEAE frequency ranged from 18% (17/93) for 10 mg once daily to 26% (24/91) for 60 mg twice daily, versus 16% (30/186) for placebo. Seven participants reported a total of eight serious TEAEs (two participants each in the placebo, 30 mg once-daily, and 60 mg once-daily groups, and one participant in the 10 mg once-daily group). TEAEs leading to discontinuation were reported in 33 (5%) of 639 atogepant participants and 5 (3%) of 186 of those randomised to placebo. All serious TEAEs were unrelated to treatment.
INTERPRETATION


All doses of oral atogepant were associated with a significant decrease in monthly migraine days over 12 weeks compared with placebo. Atogepant was safe and well tolerated over 12 weeks, supporting its phase 3 development for the preventive treatment of migraine.
FUNDING


Allergan (before its acquisition by AbbVie).",2020,All doses of oral atogepant were associated with a significant decrease in monthly migraine days over 12 weeks compared with placebo.,"['714 (87%) of 825 participants were female, 628 (76%) were white, median migraine duration was 17·5 years (IQR 10·0-28·0), and 232 (28%) had previously used preventive treatment', 'adults (aged 18-75 years), with a history (≥1 year) of migraine and 4-14 migraine days per month', 'Between Sept 6, 2016, and April 23, 2018, of 1772 individuals screened, 834 were randomly assigned and 825 received one dose or more of study medication: 186 received', 'episodic migraine in adults', '795 patients: 178 received', '78 academic and private practice settings in the USA']",['placebo'],"['Safety, tolerability, and efficacy', 'fatigue', 'least-squares mean (SE) change', 'safety and tolerability', 'safety, tolerability, and efficacy', 'monthly migraine days', 'nausea', 'safe and well tolerated']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0556971', 'cui_str': 'days/month'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4760993', 'cui_str': 'Episodic migraine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0149931', 'cui_str': 'Migraine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",834.0,0.533574,All doses of oral atogepant were associated with a significant decrease in monthly migraine days over 12 weeks compared with placebo.,"[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, SLaM Biomedical Research Centre, King's College London, London, UK. Electronic address: UKpeter.goadsby@kcl.ac.uk.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Mayo Clinic, Phoenix, AZ, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ailani', 'Affiliation': 'Medstar Georgetown University Hospital, Washington DC, USA.'}, {'ForeName': 'Joel M', 'Initials': 'JM', 'LastName': 'Trugman', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Finnegan', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Kaifeng', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Szegedi', 'Affiliation': 'AbbVie, Madison, NJ, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30234-9']
2859,32822650,Multisite Randomized Controlled Trial of Bladder Management in Labor With Epidural Analgesia/Anesthesia.,"OBJECTIVE


To compare the effects of continuous indwelling catheterization with those of intermittent catheterization during labor with epidural analgesia/anesthesia on mode of birth and incidence of urinary tract infection (UTI) symptoms in the postpartum period.
DESIGN


Randomized clinical trial.
SETTING


Labor and delivery units at three metropolitan hospitals in the Western United States.
PARTICIPANTS


Women (N = 252) who were nulliparous with term, singleton pregnancies in labor with epidural analgesia/anesthesia.
METHODS


Participants were randomized to indwelling or intermittent (every 2 hours) catheterization groups after the administration of epidural analgesia/anesthesia during labor. One to 2 weeks after discharge, participants were contacted and questioned about symptoms of UTI.
RESULTS


A total of 252 participants were enrolled in the study: 81% (n = 202) gave birth vaginally, and 19% (n = 50) gave birth via cesarean. Between the indwelling and intermittent catheterization groups, demographic characteristics were similar. We found no significant difference in the incidence of cesarean birth between groups (15.6% vs. 22.5%, p = .172). Overall, 3% of participants reported and sought treatment for symptoms of UTI within 2 weeks with no significant difference between groups (p = .929).
CONCLUSION


We found no differences in mode of birth or symptoms of UTI in women who received indwelling or intermittent catheterization during epidural analgesia/anesthesia. We recommend additional research with objective data for UTI diagnosis and larger samples to study the multiple potential confounding variables associated with cesarean birth after catheterization during epidural analgesia/anesthesia.",2020,We found no differences in mode of birth or symptoms of UTI in women who received indwelling or intermittent catheterization during epidural analgesia/anesthesia.,"['Labor', 'Labor and delivery units at three metropolitan hospitals in the Western United States', 'Women (N\xa0= 252) who were nulliparous with term, singleton pregnancies in labor with epidural analgesia/anesthesia', 'Participants', 'women who received indwelling or intermittent catheterization during epidural analgesia/anesthesia', 'A total of 252 participants were enrolled in the study: 81%\xa0(n\xa0= 202) gave birth vaginally, and 19%\xa0(n\xa0= 50) gave birth via cesarean']","['Epidural Analgesia/Anesthesia', 'epidural analgesia/anesthesia during labor', 'epidural analgesia/anesthesia', 'Bladder Management', 'continuous indwelling catheterization']","['cesarean birth', 'mode of birth or symptoms of UTI', 'mode of birth and incidence of urinary tract infection (UTI) symptoms', 'incidence of cesarean birth']","[{'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C1321138', 'cui_str': 'Labor and delivery unit'}, {'cui': 'C0020029', 'cui_str': 'Urban Hospitals'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0022864', 'cui_str': 'Labor'}, {'cui': 'C1161197', 'cui_str': 'Bladder care assessment'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439848', 'cui_str': 'Indwelling'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",252.0,0.142303,We found no differences in mode of birth or symptoms of UTI in women who received indwelling or intermittent catheterization during epidural analgesia/anesthesia.,"[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Dempsey', 'Affiliation': ''}, {'ForeName': 'Cyndy', 'Initials': 'C', 'LastName': 'Krening', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vorgic', 'Affiliation': ''}]","Journal of obstetric, gynecologic, and neonatal nursing : JOGNN",['10.1016/j.jogn.2020.07.005']
2860,32822653,The plasma levels of atrial natriuretic peptide and brain natriuretic peptide in type 2 diabetes treated with sodium-glucose cotransporter-2 inhibitor.,"PURPOSE


The aim of this study was to determine the levels of atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP) after treatment with an SGLT2 inhibitor or DPP4 inhibitor in patients with type 2 diabetes mellitus that was inadequately controlled with insulin and to understand whether the variation of ANP may explain the favorable cardiovascular outcome.
METHODS


We enrolled 56 patients with type 2 diabetes mellitus that was inadequately controlled with insulin; the subjects were all 18∼80 years of age. After receiving a stable mean dose of ≥ 20 IU and ≤ 150 IU injectable insulin daily combined with or without no more than two oral antidiabetic agents for at least 8 weeks, patients who still experienced inadequate glycaemic control (HbA1c levels of 7.5∼10.5 %) were recruited.
FINDINGS


A total of 56 patients were enrolled in this study and randomized into three groups, including an SGLT2 inhibitor group (n=18), a DPP4 inhibitor group (n=19) and a placebo group (n=19). Patients who received SGLT2 inhibitor or DPP4 inhibitor treatment all had significantly decreased HbA1c levels, fasting blood glucose (FBG) levels and systolic blood pressure at 24 weeks compared with patients treated with a placebo. SGLT2 inhibitor treatment decreased ANP levels, BNP levels, systolic blood pressure and weight compared with placebo treatment. Compared with patients who received DPP4 inhibitor treatment, patients who received SGLT2 inhibitor treatment showed lower HbA1c levels (7.01 vs 7.58 % in the DPP4 inhibitor group; P =0.03), ANP levels (28.41 vs 43.03 pg/ml in the DPP4 inhibitor group; P =0.00), and weight (66.14 vs 71.76 kg in the DPP4 inhibitor group; P =0.04) at 24 weeks after adjusting for the baseline values. The SGLT2 inhibitor group showed higher sodium concentrations compared with the placebo group and the DPP4 inhibitor group (145.89 vs 143.89 and 144.79 mmol/l, respectively; P = 0.00 and P = 0.04) at 24 weeks. ANP and BNP levels were not significantly correlated with HbA1c and blood glucose levels.
IMPLICATIONS


These results indicated that SGLT2 inhibitors may be superior to DPP4 inhibitor to help to significantly reduce the risk of development of the cardiovascular disease in patients with diabetes. But the major limitation concerns the little number of patients included within each group in this study. This small sample size could be enlarged in further research.",2020,"Patients who received SGLT2 inhibitor or DPP4 inhibitor treatment all had significantly decreased HbA1c levels, fasting blood glucose (FBG) levels and systolic blood pressure at 24 weeks compared with patients treated with a placebo.","['patients with diabetes', '56 patients with type 2 diabetes mellitus that was inadequately controlled with insulin; the subjects were all 18∼80 years of age', 'A total of 56 patients', 'patients with type 2 diabetes mellitus', 'patients who still experienced inadequate glycaemic control (HbA1c levels of 7.5∼10.5 %) were recruited']","['DPP4 inhibitor', 'placebo', 'SGLT2 inhibitor', 'SGLT2', 'sodium-glucose cotransporter-2 inhibitor', 'SGLT2 inhibitor or DPP4 inhibitor', 'injectable insulin daily combined with or without no more than two oral antidiabetic agents']","['ANP and BNP levels', 'weight', 'levels of atrial natriuretic peptide (ANP) and brain natriuretic peptide (BNP', 'sodium concentrations', 'plasma levels of atrial natriuretic peptide and brain natriuretic peptide', 'ANP levels', 'HbA1c and blood glucose levels', 'HbA1c levels, fasting blood glucose (FBG) levels and systolic blood pressure', 'lower HbA1c levels', 'ANP levels, BNP levels, systolic blood pressure and weight']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C1505133', 'cui_str': 'SLC5A2 protein, human'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}]","[{'cui': 'C0027481', 'cui_str': 'A-type natriuretic peptide'}, {'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",56.0,0.0715293,"Patients who received SGLT2 inhibitor or DPP4 inhibitor treatment all had significantly decreased HbA1c levels, fasting blood glucose (FBG) levels and systolic blood pressure at 24 weeks compared with patients treated with a placebo.","[{'ForeName': 'Xiu', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: show_clancy@foxmail.com.'}, {'ForeName': 'Gu', 'Initials': 'G', 'LastName': 'Qingwei', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: gqw9299@163.com.'}, {'ForeName': 'Gu', 'Initials': 'G', 'LastName': 'Gao', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: feifeigalt@163.com.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: happy_yuanlu@126.com.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: shygu@njmu.edu.cn.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, 68 Changle Road, Qinhuai District, Nanjing, Jiangsu Province, China. Electronic address: zhangying932@163.com.'}]",Annales d'endocrinologie,['10.1016/j.ando.2020.07.1113']
2861,32822656,Physiology-guided revascularization versus optimal medical therapy of non-culprit lesions in elderly patients with myocardial infarction: Rationale and design of the FIRE trial.,"BACKGROUND


Myocardial infarction (MI) in elderly patients is associated with unfavorable prognosis, and it is becoming an increasingly prevalent condition. The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD). Given the limited evidence available for elderly patients, it has not yet been established whether, as for younger patients, a complete revascularization strategy in MI patients with MVD should be advocated. We present the design of a dedicated study that will address this research gap.
METHODS AND DESIGN


The FIRE trial is a prospective, randomized, international, multicenter, open-label study with blinded adjudicated evaluation of outcomes. Patients aged 75years and older, with MI (either STE or NSTE), MVD at coronary artery angiography and a clear culprit lesion will be randomized to culprit-only treatment or to physiology-guided complete revascularization. The primary endpoint will be the patient-oriented composite endpoint (POCE) of all cause death, any MI, any stroke, any revascularization at one year. The key secondary endpoint will be the composite of cardiovascular death and MI. Quality of life and physical performance will be evaluated as well. All components of the primary and key secondary outcome will be tested also at 3 and 5years. The sample size for the study is 1400 patients.
IMPLICATIONS


The FIRE trial will provide evidence on whether a specific revascularization strategy should be applied to elderly patients presenting MI and MVD in order to improve their clinical outcomes.",2020,"The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD).","['1400 patients', 'elderly patients with myocardial infarction', 'Patients aged 75years and older, with MI (either STE or NSTE), MVD at coronary artery angiography and a clear culprit lesion', 'elderly patients']",['Physiology-guided revascularization versus optimal medical therapy'],"['patient-oriented composite endpoint (POCE) of all cause death, any MI, any stroke, any revascularization at one year', 'composite of cardiovascular death and MI', 'Quality of life and physical performance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0038340', 'cui_str': 'Sting'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0629355,"The prognosis of elderly patients is equally impaired in ST-segment elevation (STE) or non-STE (NSTE), and it is markedly worsened by the common presence of multivessel disease (MVD).","[{'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Biscaglia', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro 8, Ferrara, Italy. Electronic address: bscsmn@unife.it.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Guiducci', 'Affiliation': 'Cardiology Unit, Azienda USL-IRCCS Reggio Emilia, S. Maria Nuova Hospital, Viale Risorgimento 80, Reggio Emilia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Santarelli', 'Affiliation': 'Cardiovascular Department, Infermi Hospital, Viale Luigi Settembrini 2, Rimini, Italy.'}, {'ForeName': 'Ignacio Amat', 'Initials': 'IA', 'LastName': 'Santos', 'Affiliation': 'CIBERCV, Cardiology Department, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Fernandez-Aviles', 'Affiliation': 'Servicio de Cardiología, Hospital General Universitario Gregorio Marañón, CIBERCV, Calle del Dr Esquerdo 46, Madrid, Spain; Universidad Carlos III, Calle Madrid 126, Madrid, Spain.'}, {'ForeName': 'Valerio', 'Initials': 'V', 'LastName': 'Lanzilotti', 'Affiliation': 'U.O.C. Cardiologia, Ospedale Maggiore, Largo Nigrisoli 2, Bologna, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Varbella', 'Affiliation': 'Department of Cardiology, Infermi Hospital, Rivoli, Italy; Department of Cardiology, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Fileti', 'Affiliation': 'Cardiology Department, S. Maria delle Croci Hospital, Viale Randi 5, Ravenna, Italy.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Moreno', 'Affiliation': 'Instituto de Investigación Hospital La Paz (IDIPAZ), University Hospital La Paz, Madrid, Spain, Madrid; Centro de Investigación Biomédica en Red en Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giannini', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy.'}, {'ForeName': 'Iginio', 'Initials': 'I', 'LastName': 'Colaiori', 'Affiliation': 'Cardiology Unit, Azienda USL-IRCCS Reggio Emilia, S. Maria Nuova Hospital, Viale Risorgimento 80, Reggio Emilia, Italy.'}, {'ForeName': 'Mila', 'Initials': 'M', 'LastName': 'Menozzi', 'Affiliation': 'Cardiovascular Department, Infermi Hospital, Viale Luigi Settembrini 2, Rimini, Italy.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Redondo', 'Affiliation': 'CIBERCV, Cardiology Department, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ruozzi', 'Affiliation': 'Cardiology Unit, Ospedale Civile di Baggiovara, Modena, Italy.'}, {'ForeName': 'Enrique Gutiérrez', 'Initials': 'EG', 'LastName': 'Ibañes', 'Affiliation': 'Servicio de Cardiología, Hospital General Universitario Gregorio Marañón, CIBERCV, Calle del Dr Esquerdo 46, Madrid, Spain; Universidad Carlos III, Calle Madrid 126, Madrid, Spain.'}, {'ForeName': 'José Luis Díez', 'Initials': 'JLD', 'LastName': 'Gil', 'Affiliation': 'Servicio de Cardiología, H. Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Maietti', 'Affiliation': 'Department of Medical Science, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Giuseppe Biondi', 'Initials': 'GB', 'LastName': 'Zoccai', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Mediterranea Cardiocentro, Napoli, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clínico San Carlos IDISCC, Complutense University of Madrid, Calle del Prof Martin Lagos s/n, Madrid, Spain.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Tebaldi', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro 8, Ferrara, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': 'Division of Cardiology, Department of Advanced Biomedical Sciences, Federico II University, Via Pansini, Naples, Italy.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy; Institute of Cardiology, Jagiellonian University Medical College, ul. Sw Anny 12, Krakow, Poland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Colombo', 'Affiliation': 'Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero Universitaria di Ferrara, Via Aldo Moro 8, Ferrara, Italy; Maria Cecilia Hospital, GVM Care & Research, Via Corriera 1, Cotignola, Italy.'}]",American heart journal,['10.1016/j.ahj.2020.08.007']
2862,32822676,Survival After Detection of Stage I Lung Cancer by Screening in the National Lung Screening Trial.,"BACKGROUND


There is limited information about survival of Stage I lung cancer diagnosed by screening.
RESEARCH QUESTION


What was the survival rate of screen-detected Stage I lung cancer in the National Lung Screening Trial (NLST), and was it affected by screening method, patient or tumor characteristics, or treatment method?
STUDY DESIGN AND METHODS


The study cohort consisted of all NLST participants with screen-detected Stage I lung cancer. Lung cancer-specific survival for Stage I overall and for IA and IB substages were compared in the low dose CT (CT) and chest radiography (CXR) screening randomization arms, and with an analogous cohort from the Surveillance, Epidemiology, and End Results Program (SEER) of the National Cancer Institute, using the cumulative incidence competing risk method. Cox proportional hazards models were used to evaluate the association between lung cancer-specific survival and screening arm, patient factors, primary tumor size, and treatment.
RESULTS


There were 324 screen-detected Stage I lung cancers in the CT arm and 125 in the CXR arm. The 10-year survival in the CT arm was greater than in the CXR arm (73.4% vs. 64.6%, p=0.05), and both were greater than in SEER (55.6%, p<0.001 vs. CT arm, p=0.04 vs CXR arm). Proportional hazards models revealed greater likelihood of survival in the CT arm (HR 0.69, 95% CI 0.5-0.98), and with primary tumor size below the median of 17 mm (HR 0.61, 95% CI 0.42-0.88). There was no survival difference between treatment with limited resection vs. full resection (HR 1.12, 95% CI 0.65-1.9), while nonsurgical treatment was associated with reduced likelihood of survival compared to full resection (HR 3.0, 95% CI 1.5-5.9).
INTERPRETATION


Long-term lung cancer-specific survival of Stage I lung cancer was greater with CT than with CXR screening or in the general population, for smaller primary tumor size, and with surgical treatment.",2020,"There was no survival difference between treatment with limited resection vs. full resection (HR 1.12, 95% CI 0.65-1.9), while nonsurgical treatment was associated with reduced likelihood of survival compared to full resection (HR 3.0, 95% CI 1.5-5.9).
","['participants with screen-detected Stage I lung cancer', 'I lung cancer diagnosed by screening']","['CT', 'NLST']","['survival difference', '324 screen-detected Stage I lung cancers', 'Survival', 'survival rate of screen-detected Stage I lung cancer', '10-year survival', 'likelihood of survival', 'Lung cancer-specific survival']","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C4517713', 'cui_str': '324'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",,0.198326,"There was no survival difference between treatment with limited resection vs. full resection (HR 1.12, 95% CI 0.65-1.9), while nonsurgical treatment was associated with reduced likelihood of survival compared to full resection (HR 3.0, 95% CI 1.5-5.9).
","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Gierada', 'Affiliation': 'Mallinckrodt Institute of Radiology, Washington University School of Medicine. Electronic address: gieradad@wustl.edu.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Pinsky', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute.'}]",Chest,['10.1016/j.chest.2020.08.2048']
2863,32822683,Randomized study of antiseptic application technique in healthy volunteers before vascular access insertion (TApAS trial).,"Background In France about 32% of hospitalized patients have a vascular access placement. However, a common complication associated with these is catheter-related bloodstream infection (CRBI) due to the introduction of microorganisms from the skin during catheter insertion. There is no consensus on the best way to clean the skin prior to catheter insertion, which could be a key element of CRBI prevention. The two techniques most commonly used to apply antiseptic to the skin are the concentric circle and back-and-forth techniques, but these have not been compared in clinical trials. Hence, this study conducted this comparison. Methods This single-center, non-comparative, randomized, matched pilot study investigated the levels of cutaneous microorganisms before and after antiseptic application using both techniques in a population of healthy French volunteers. The two application methods were used on each participant's arms at the elbow fold, with randomization for the application side (right or left). Quantification of cutaneous microorganisms was performed in a blinded manner with regard to the technique used. Findings From April 8 to July 17, 2019, 132 healthy volunteers participated in the study. For the whole study population, the mean initial colonization level was 2.68 log10 colony forming units (CFU)/mL (SD 0.82) before the back-and-forth technique, and 2.66 log10 CFU/mL (SD 0.85) before the concentric circle technique. The mean differences in number of microorganisms between the initial sample and the final sample were 2.45 log10 CFU/mL (95% CI: 2.29 to 2.61) for the back-and-forth technique and 2.43 log10 CFU/mL (95% CI: 2.27 to 2.59) for the concentric circle technique. The mean difference in reduction in microorganisms between the back-and-forth technique and the concentric circle technique was 0.02 log10 CFU/mL (95% CI: -0.11 to 0.15). Interpretation There was no clinically difference in reduction of microorganisms between the concentric circle and back-and-forth techniques at the bend of the healthy volunteer's elbow, after the 30 seconds of drying of the antiseptic. These findings have a significant impact on time required to achieve antiseptic application before catheter insertion because there is yet no argument to justify application for 30 s, because a single concentric circle pass was much faster with similar results. Future studies should investigate the impact of skin application technique on the prevention of infectious risk associated with catheter insertion on admission to health care facilities (conventional, outpatient, or emergency) and throughout the period of stay in a health care facility.",2020,"There was no clinically difference in reduction of microorganisms between the concentric circle and back-and-forth techniques at the bend of the healthy volunteer's elbow, after the 30 seconds of drying of the antiseptic.","['healthy French volunteers', 'healthy volunteers before vascular access insertion (TApAS trial', 'Findings From April 8 to July 17, 2019, 132 healthy volunteers participated in the study']","['antiseptic application technique', 'log10 CFU/mL', 'CFU/mL']",['mean initial colonization level'],"[{'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0003205', 'cui_str': 'Antiseptic agent'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1690986', 'cui_str': 'log10'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2945590', 'cui_str': 'U/mL'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",132.0,0.0404688,"There was no clinically difference in reduction of microorganisms between the concentric circle and back-and-forth techniques at the bend of the healthy volunteer's elbow, after the 30 seconds of drying of the antiseptic.","[{'ForeName': 'Yolène', 'Initials': 'Y', 'LastName': 'Carre', 'Affiliation': 'CHU de Bordeaux, Pôle de Santé Publique, Infection Control Unit, Bordeaux, F-33000, France. Electronic address: yolenecarre@gmail.com.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Moal', 'Affiliation': ""CHU Bordeaux, Service d'information médicale, F-33000 Bordeaux, France.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Germain', 'Affiliation': ""CHU Bordeaux, Service d'information médicale, F-33000 Bordeaux, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Frison', 'Affiliation': ""CHU Bordeaux, Service d'information médicale, F-33000 Bordeaux, France.""}, {'ForeName': 'Marielle', 'Initials': 'M', 'LastName': 'Dubreuil', 'Affiliation': 'Université de Bordeaux, Bordeaux Population Health Research Center, Pharmacoépidémiologie, UMR 1219, F-33000 Bordeaux, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Chansel', 'Affiliation': 'CHU de Bordeaux, Nursing Training Institute, F-33000, Bordeaux, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Berger', 'Affiliation': 'CHU Bordeaux Care and human sciences research unit - F-33000 Bordeaux France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Boulestreau', 'Affiliation': 'CHU de Bordeaux, Pôle de Santé Publique, Infection Control Unit, Bordeaux, F-33000, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Lasheras-Bauduin', 'Affiliation': 'CHU de Bordeaux, Pôle de Santé Publique, Infection Control Unit, Bordeaux, F-33000, France.'}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Rogues', 'Affiliation': 'CHU de Bordeaux, Pôle de Santé Publique, Infection Control Unit, Bordeaux, F-33000, France; Université de Bordeaux, Bordeaux Population Health Research Center, Pharmacoépidémiologie, UMR 1219, F-33000 Bordeaux, France.'}]",The Journal of infection,['10.1016/j.jinf.2020.08.022']
2864,32822692,Effect of early and late prenatal vitamin D and maternal asthma status on offspring asthma or recurrent wheeze.,"BACKGROUND


Childhood asthma developmental programming is complex. Maternal asthma is a strong risk factor for childhood asthma, while vitamin D (VD) has emerged as a modifiable prenatal exposure.
OBJECTIVE


To examine the combined effect of early and late prenatal VD status in pregnancies with and without asthma on childhood asthma/recurrent wheeze development.
METHODS


We conducted a cohort study using prospectively collected data from the Vitamin D Antenatal Asthma Reduction Trial (VDAART), a randomized, double-blinded, placebo-controlled vitamin D supplementation trial in pregnant women at high risk of offspring asthma (N=806 mother-offspring pairs). 25-hydroxyvitamin-D [25(OH)D] was measured in early and late pregnancy. Our main exposure was an ordered variable representing early and late prenatal VD sufficiency [25(OH)D>30ng/mL)] status in pregnancies with and without asthma. The primary outcome was offspring asthma or recurrent wheeze by age 3 years. We also examined the effect of prenatal VD on early life asthma/recurrent wheeze progression to active asthma at age 6 years.
RESULTS


Among maternal asthmatics, compared to those with early and late prenatal VD insufficiency, those with early or late VD sufficiency (aOR=0.56; 95% CI 0.31-1.00) or early and late VD sufficiency (aOR=0.36; 95% CI 0.15-0.81) had lower risk of offspring asthma/recurrent wheeze by age 3 years (P for trend =0.008). This protective trend was reiterated in asthma/recurrent wheeze progression to active asthma from age 3 to 6 years (P for trend =0.04).
CONCLUSION


This study implicates a protective role for VD sufficiency throughout pregnancy, particularly in attenuating the risk conferred by maternal asthma on childhood asthma/recurrent wheeze development.
CLINICAL IMPLICATION


Early identification and correction of vitamin D insufficiency in asthmatic pregnant women have implications for the prevention of early offspring asthma/recurrent wheeze and the persistence of offspring asthma to later childhood.",2020,"This protective trend was reiterated in asthma/recurrent wheeze progression to active asthma from age 3 to 6 years (P for trend =0.04).
","['early life asthma/recurrent wheeze progression to active asthma at age 6 years', 'pregnant women at high risk of offspring asthma (N=806 mother-offspring pairs', 'pregnancies with and without asthma on childhood asthma/recurrent wheeze development', 'asthmatic pregnant women', 'offspring asthma or recurrent wheeze', 'pregnancies with and without asthma']","['early and late prenatal vitamin D', 'Vitamin D Antenatal Asthma Reduction Trial (VDAART', 'prenatal VD', 'placebo-controlled vitamin D supplementation']","['25-hydroxyvitamin-D [25(OH)D', 'offspring asthma or recurrent wheeze by age 3 years', 'lower risk of offspring asthma/recurrent wheeze']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0772413', 'cui_str': 'Prenatal vitamin'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}]",,0.10878,"This protective trend was reiterated in asthma/recurrent wheeze progression to active asthma from age 3 to 6 years (P for trend =0.04).
","[{'ForeName': 'Mengdi', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': ""Division of Pediatric Pulmonary Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Augusto A', 'Initials': 'AA', 'LastName': 'Litonjua', 'Affiliation': ""Division of Pediatric Pulmonary Medicine, Golisano Children's Hospital at University of Rochester Medical Center, Rochester, NY, USA.""}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': ""O'Connor"", 'Affiliation': 'Pulmonary Center, Department of Medicine, Boston Medical Center, Boston University, Boston, MA, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Zeiger', 'Affiliation': 'Department of Allergy and Research and Evaluation, Kaiser Permanente Southern California Region, San Diego and Pasadena, CA, USA.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Bacharier', 'Affiliation': 'Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schatz', 'Affiliation': 'Department of Allergy and Research and Evaluation, Kaiser Permanente Southern California Region, San Diego and Pasadena, CA, USA.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Carey', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Mirzakhani', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. Electronic address: hoomi@post.harvard.edu.""}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.06.041']
2865,32822775,Tocilizumab improves oxidative stress and endothelial glycocalyx: A mechanism that may explain the effects of biological treatment on COVID-19.,"We investigated the effects of tocilizumab on endothelial glycocalyx, a determinant of vascular permeability, and myocardial function in rheumatoid arthritis(RA). Eighty RA patients were randomized to tocilizumab(n=40) or conventional synthetic disease-modifying antirheumatic drugs(csDMARDs) and glucocorticoids(GC) (n=40) for 3 months. Forty healthy subjects with similar age and sex served as controls. We measured: a)perfused boundary region(PBR) of the sublingual arterial microvessels (increased PBR indicates reduced glycocalyx thickness), b)pulse wave velocity(PWV), c)global LV longitudinal strain(GLS), d)global work index(GWI) using speckle tracking echocardiography and e)C-reactive protein(CRP), malondialdehyde(MDA) and protein carbonyls(PCs) as oxidative stress markers at baseline and post-treatment. Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05). Compared with baseline, tocilizumab reduced PBR(2.14±0.2 versus 1.97±0.2μm; P<0.05) while no significant differences were observed post-csDMARDs+GC(P>0.05). Compared with csDMARDs+GC, tocilizumab achieved a greater increase of GLS, GWI and reduction of MDA, PCs and CRP(P<0.05). The percent improvement of glycocalyx thickness(PBR) was associated with the percent decrease of PWV, MDA, PCs and the percent improvement of GLS and GWI(P<0.05). Tocilizumab improves endothelial function leading to a greater increase of effective myocardial work than csDMARDs+GC through a profound reduction of inflammatory burden and oxidative stress. This mechanism may explain the effects of tocilizumab on COVID-19. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03288584.",2020,"Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05).","['Eighty RA patients', 'Forty healthy subjects with similar age and sex served as controls', 'rheumatoid arthritis(RA']","['csDMARDs+GC', 'tocilizumab', 'csDMARDs+GC, tocilizumab', 'Tocilizumab', 'tocilizumab(n=40) or conventional synthetic disease-modifying antirheumatic drugs(csDMARDs) and glucocorticoids(GC']","['glycocalyx thickness), b)pulse wave velocity(PWV), c)global LV longitudinal strain(GLS), d)global work index(GWI) using speckle tracking echocardiography and e)C-reactive protein(CRP), malondialdehyde(MDA) and protein carbonyls(PCs) as oxidative stress markers', 'PWV, MDA, PCs and the percent improvement of GLS and GWI(P<0.05', 'oxidative stress and endothelial glycocalyx', 'glycocalyx thickness(PBR', 'GLS, GWI and reduction of MDA, PCs and CRP(P<0.05']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242708', 'cui_str': 'Disease-Modifying Antirheumatic Drugs'}]","[{'cui': 'C0061622', 'cui_str': 'Glycocalyx'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439691', 'cui_str': 'Speckled'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017767', 'cui_str': 'Glucosinolate'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",80.0,0.0830911,"Compared to controls, RA patients had impaired glycocalyx and myocardial deformation markers(P<0.05).","[{'ForeName': 'Ignatios', 'Initials': 'I', 'LastName': 'Ikonomidis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece. Electronic address: ignoik@gmail.com.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Pavlidis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Pelagia', 'Initials': 'P', 'LastName': 'Katsimbri', 'Affiliation': '4th Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Vaia', 'Initials': 'V', 'LastName': 'Lambadiari', 'Affiliation': '2nd Department of Internal Medicine, Research Unit and Diabetes Center, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Parissis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Andreadou', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, National and Kapodistrian University of Athens, 15741, Athens, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Tsoumani', 'Affiliation': 'Laboratory of Pharmacology, Faculty of Pharmacy, National and Kapodistrian University of Athens, 15741, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Boumpas', 'Affiliation': '4th Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Kouretas', 'Affiliation': 'Department of Biochemistry and Biotechnology, University of Thessaly, 41500, Larissa, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Iliodromitis', 'Affiliation': '2nd Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Medical School, 12462, Athens, Greece.'}]",Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association,['10.1016/j.fct.2020.111694']
2866,32822827,A community-based asthma program: Study design and methods of RVA breathes.,"Disparities in pediatric asthma morbidity and healthcare utilization exist on the basis of race, ethnicity, environment, and income; interventions are needed to address these inequities. The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors. Community stakeholder feedback was utilized to refine the intervention specifically for the Richmond, Virginia community. The aims of this study are to assess the effect of RVA Breathes on asthma-related healthcare utilization, as well as secondary outcomes of asthma control, asthma symptoms, and quality of life. We will enroll 300 elementary school children from the Richmond City Public School system. Participants will be between the ages of 5-11, have a diagnosis of asthma, and have had an asthma exacerbation (as indicated by an asthma-related ED visit, hospitalization, unscheduled PCP visit, or use of systemic steroids) in the last two years. Participants will be randomized to one of three groups: asthma education + home environment remediation + school intervention, asthma education + home environment remediation, or a comparator condition. Data will be collected across one baseline research visit, four intervention sessions, and four follow-up research visits over the course of 18 months. A General Linear Mixed Model (GLMM) will be used to test primary aims. We expect the findings will provide support for coordination of asthma care across sectors. Further, we hope RVA Breathes will serve as a model of community-based pediatric asthma care.",2020,"The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors.","['Participants will be between the ages of 5-11, have a diagnosis of asthma, and have had an asthma exacerbation (as indicated by an asthma-related ED visit, hospitalization, unscheduled PCP visit, or use of systemic steroids) in the last two years', '300 elementary school children from the Richmond City Public School system']","['asthma education + home environment remediation + school intervention, asthma education + home environment remediation, or a comparator condition', 'RVA']","['asthma control, asthma symptoms, and quality of life']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0030855', 'cui_str': 'Pentachlorophenol'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0557800', 'cui_str': 'Public school'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",300.0,0.0360733,"The following protocol describes an evidence-based intervention, RVA Breathes, designed to coordinate pediatric asthma care across family, home, community, and medical sectors.","[{'ForeName': 'Robin S', 'Initials': 'RS', 'LastName': 'Everhart', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America. Electronic address: reverhart@vcu.edu.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Mazzeo', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Rosalie', 'Initials': 'R', 'LastName': 'Corona', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Rachel L', 'Initials': 'RL', 'LastName': 'Holder', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Leroy R', 'Initials': 'LR', 'LastName': 'Thacker', 'Affiliation': 'Virginia Commonwealth University, Richmond, VA, United States of America.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Schechter', 'Affiliation': ""Children's Hospital of Richmond at VCU, Richmond, VA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106121']
2867,32822887,"Efficacy and Safety of Low-Molecular-Weight Heparin on Prevention of Venous Thromboembolism after Laparoscopic Operation for Gastrointestinal Malignancy in Japanese Patients: A Multicenter, Open-Label, Prospective, Randomized Controlled Trial.","BACKGROUND


The risk of venous thromboembolism (VTE) after surgery for malignancy in Japanese patients is unclear; hence, standard prevention protocols have not been established, especially for minimally invasive surgeries. We aimed to investigate the additional effect of low-molecular-weight heparin (LMWH) on the prevention of VTE after laparoscopic surgery for gastrointestinal malignancy.
STUDY DESIGN


From February 2013 to January 2017, Four hundred patients scheduled for laparoscopic surgery were included. Cases were randomly allocated to the physical therapy group (Control group; 201 patients) or to the combination-therapy group (LMWH group; 199 patients) in which enoxaparin sodium (20 mg twice a day) was administered for 1 week postoperatively in addition to the physical therapy. A diagnosis of VTE was made by contrast-enhanced computed tomography or ultrasonography when symptomatic or D-dimer was ≥10 μg/ml.
RESULTS


VTE was observed in 1.2% and 4.0% patients of the LMWH and Control groups, respectively (odds ratio [OR]=0.3, 95% confidence interval [CI]: 0.03-1.53). Pulmonary embolism was confirmed only in the Control group (1.7%). No major bleeding occurred in either group. Logistic multiple regression analysis revealed that surgical time extension (OR=1.02, 95%CI: 1.00-1.04) was a risk factor of VTE, while administration of LMWH (OR=0.21, 95%CI: 0.03-0.99), male sex (OR=0.12, 95%CI: 0.01-0.60), and early cancer (OR=0.17, 95%CI: 0.02-0.82) reduced the risk of VTE.
CONCLUSIONS


Postoperative LMWH administration is safe. The additional effect of the LMWH administration to the physical therapy was not statistically proved in this study. However, it could be useful for the patients with risk factors such as female, long operation time, and higher cancer stage.",2020,"Logistic multiple regression analysis revealed that surgical time extension (OR=1.02, 95%CI: 1.00-1.04) was a risk factor of VTE, while administration of LMWH (OR=0.21, 95%CI: 0.03-0.99), male sex (OR=0.12, 95%CI: 0.01-0.60), and early cancer (OR=0.17, 95%CI: 0.02-0.82) reduced the risk of VTE.
","['Japanese Patients', 'From February 2013 to January 2017, Four hundred patients scheduled for laparoscopic surgery were included', 'Japanese patients']","['LMWH', 'Low-Molecular-Weight Heparin', 'low-molecular-weight heparin (LMWH', 'physical therapy group (Control group; 201 patients) or to the combination-therapy group (LMWH group; 199 patients) in which enoxaparin sodium', 'Laparoscopic Operation']","['Pulmonary embolism', 'VTE', 'surgical time extension', 'major bleeding', 'risk of VTE', 'Venous Thromboembolism']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0724579', 'cui_str': 'Enoxaparin sodium'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",400.0,0.0725743,"Logistic multiple regression analysis revealed that surgical time extension (OR=1.02, 95%CI: 1.00-1.04) was a risk factor of VTE, while administration of LMWH (OR=0.21, 95%CI: 0.03-0.99), male sex (OR=0.12, 95%CI: 0.01-0.60), and early cancer (OR=0.17, 95%CI: 0.02-0.82) reduced the risk of VTE.
","[{'ForeName': 'Tamotsu', 'Initials': 'T', 'LastName': 'Obitsu', 'Affiliation': 'Department of Surgery, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Oyama', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, Sendai, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Department of Surgery, South Miyagi Medical Center, Shibata-gun, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Saito', 'Affiliation': 'Department of Surgery, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan; Clinical Research Data Center, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Airi', 'Initials': 'A', 'LastName': 'Takagi', 'Affiliation': 'Clinical Research Data Center, Tohoku University Hospital, Sendai, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Rikiyama', 'Affiliation': 'Department of Surgery, Jichi Medical University Saitama Medical Center, Saitama, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Unno', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Naitoh', 'Affiliation': 'Department of Lower Gastrointestinal Surgery, Kitasato University School of Medicine, Sagamihara, Japan. Electronic address: naitot@med.kitasato-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.08.734']
2868,32822898,Temporal precedence of the change in obsessive-compulsive symptoms and change in depressive symptoms during exposure and response prevention for pediatric obsessive-compulsive disorders.,"The current study examined the temporal precedence of change in obsessive-compulsive symptoms and change in depressive symptoms during the course of an Exposure and Response Prevention (ERP) for pediatric OCD. Participants included 142 children and adolescents (7-17 years; mean age = 12.39, SD = 2.92; 51.40% female; 60.40% Non-Hispanic White) with a primary or co-primary diagnosis of OCD who received ERP in a two-site randomized controlled trial on d-cycloserine augmentation of CBT for pediatric OCD. Participants completed clinician-administered assessments of OC symptoms (Children's Yale-Brown Obsessive Compulsive Scale) and depressive symptoms (Children's Depression Rating Scale-Revised) from baseline to post-treatment follow-up. Lagged mediational analyses did not yield evidence in support of a mediating role for the change in OC symptoms in the effect of ERP on the change in depressive symptoms. In contrast, change in depressive symptoms mediated the effect of ERP treatment on the subsequent change in OC symptoms (95% confidence interval for indirect effect = -0.04 to -0.001), though the effect size was small. Controlling for the prior levels of the depressive symptoms this indirect effect became non-significant. Theoretical and clinical implications of the findings for the youth with OCD and comorbid depression are discussed.",2020,Lagged mediational analyses did not yield evidence in support of a mediating role for the change in OC symptoms in the effect of ERP on the change in depressive symptoms.,"['Participants included 142 children and adolescents (7-17 years; mean age\xa0=\xa012.39, SD\xa0=\xa02.92; 51.40% female; 60.40% Non-Hispanic White) with a primary or co-primary diagnosis of OCD who received ERP in a two-site randomized controlled trial on d-cycloserine augmentation of CBT for pediatric OCD', 'pediatric obsessive-compulsive disorders']",[],"[""clinician-administered assessments of OC symptoms (Children's Yale-Brown Obsessive Compulsive Scale) and depressive symptoms (Children's Depression Rating Scale-Revised"", 'obsessive-compulsive symptoms and change in depressive symptoms', 'depressive symptoms', 'OC symptoms']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}]",[],"[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0155339', 'cui_str': ""Brown's tendon sheath syndrome""}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",142.0,0.25284,Lagged mediational analyses did not yield evidence in support of a mediating role for the change in OC symptoms in the effect of ERP on the change in depressive symptoms.,"[{'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Bakhshaie', 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, 1977 Butler Blvd, Suite 400, Houston, TX, 77030, USA. Electronic address: jbakhshaie@mgh.harvard.edu.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Geller', 'Affiliation': 'Massachusetts General Hospital, 185 Cambridge Street, Suite 2000, Boston, MA, 02114, USA; Harvard University Medical School, 25 Shattuck St, Boston, MA, 02115, USA.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Wilhelm', 'Affiliation': 'Massachusetts General Hospital, 185 Cambridge Street, Suite 2000, Boston, MA, 02114, USA; Harvard University Medical School, 25 Shattuck St, Boston, MA, 02115, USA.'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'McGuire', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Johns Hopkins University School of Medicine, 1800 Orleans Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Brent J', 'Initials': 'BJ', 'LastName': 'Small', 'Affiliation': 'School of Aging Studies, University of South Florida, 13301 Bruce B Downs Blvd, Tampa, FL, 33620, USA.'}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Cepeda', 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, 1977 Butler Blvd, Suite 400, Houston, TX, 77030, USA.'}, {'ForeName': 'Sophie C', 'Initials': 'SC', 'LastName': 'Schneider', 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, 1977 Butler Blvd, Suite 400, Houston, TX, 77030, USA.'}, {'ForeName': 'Tanya K', 'Initials': 'TK', 'LastName': 'Murphy', 'Affiliation': ""Department of Pediatrics, University of South Florida, 2 Tampa General Cir, Tampa, FL, 33606, USA; Department of Psychiatry & Behavioral Neurosciences, University of South Florida, 3515 E Fletcher Ave, Tampa, FL, 33613, USA; Johns Hopkins Medicine All Children's Hospital, 501 6th Ave S, St. Petersburg, FL, 33701, USA.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Porth', 'Affiliation': 'Massachusetts General Hospital, 185 Cambridge Street, Suite 2000, Boston, MA, 02114, USA.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Menninger Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, 1977 Butler Blvd, Suite 400, Houston, TX, 77030, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103697']
2869,32822968,"Improvement in overall survival with Apalutamide, Darolutamide and Enzalutamide in patients with non-metastatic castration-resistant prostate cancer.","Since 2018, apalutamide, darolutamide, and enzalutamide have been approved for the treatment of men with non-metastatic castration-resistant prostate cancer (M0CRPC). These approvals were based on the results of three separate randomized, placebo-controlled, phase III trials: SPARTAN (apalutamide), ARAMIS (darolutamide) and PROSPER (enzalutamide). These trials included men with M0CRPC and a short PSA doubling time (≤10 months). Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone. Updated results of these trials presented in the 2020 annual meeting of American Society of Oncology (ASCO) showed significantly improved overall survival with these agents. Based on these results, apalutamide, darolutamide, and enzalutamide can now be considered the standard of care treatment options for the treatment of men with M0CRPC.",2020,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","['men with M0CRPC and a short PSA doubling time (≤10 months', 'men with non-metastatic castration-resistant prostate cancer (M0CRPC', 'men with M0CRPC', 'patients with non-metastatic castration-resistant prostate cancer']","['Apalutamide, Darolutamide and Enzalutamide', 'ARAMIS (darolutamide) and PROSPER (enzalutamide', 'androgen deprivation therapy (ADT', 'placebo']","['overall survival', 'longer metastasis-free survival']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4329353', 'cui_str': 'apalutamide'}, {'cui': 'C4547776', 'cui_str': 'darolutamide'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.0449496,"Results demonstrated a longer metastasis-free survival with these agents when used in conjunction with androgen deprivation therapy (ADT), compared to ADT alone.","[{'ForeName': 'Umang', 'Initials': 'U', 'LastName': 'Swami', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA. Electronic address: umang.swami@hci.utah.edu.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Division of Oncology, Department of Internal Medicine, Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2020.100205']
2870,32823200,Opposite effects of smoking and nicotine intake on cognition.,"Our main purpose was to investigate how smoking and nicotine interacted with specific aspects of cognitive functioning, namely attention and working memory. The research was conducted in two parts: (i) an investigation of cognition in heavy smokers and healthy nonsmokers, and (ii) an investigation of cognition in healthy nonsmokers enrolled in a clinical trial involving administration of nicotine gum. Results indicated that the relationship between smoking and nicotine was characterized by an inverted U-shaped. On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here. On the other hand, healthy nonsmokers who used 2-mg of nicotine gum performed better, whilst the 4-mg group performed worse than the 2-mg and the placebo group. Demographic data were not related to the outcomes. These data suggest that small doses of nicotine can have an activating function that leads to improved cognition, while heavy smoking on a chronic (and possibly acute) basis leads to cognitive impairment.",2020,"On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here.","['heavy smokers and healthy nonsmokers', 'healthy nonsmokers']","['nicotine', 'nicotine gum', 'placebo']",[],"[{'cui': 'C3494625', 'cui_str': 'Heavy tobacco smoker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.0106464,"On the one hand, cognitive test performance of the heavy smokers group was reduced on all of the cognitive tasks used here.","[{'ForeName': 'Natalia L', 'Initials': 'NL', 'LastName': 'Almeida', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil. Electronic address: natalialalmeida@hotmail.com.'}, {'ForeName': 'Stephanye J', 'Initials': 'SJ', 'LastName': 'Rodrigues', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Letícia M', 'Initials': 'LM', 'LastName': 'Gonçalves', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Silverstein', 'Affiliation': 'University of Rochester Medical Center, Department of Psychiatry, NY, USA.'}, {'ForeName': 'Isadora C', 'Initials': 'IC', 'LastName': 'Sousa', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}, {'ForeName': 'Giulliana H', 'Initials': 'GH', 'LastName': 'Gomes', 'Affiliation': 'Medical Sciences College, Brazil.'}, {'ForeName': 'Pamela D', 'Initials': 'PD', 'LastName': 'Butler', 'Affiliation': 'Nathan Kline Institute for Psychiatric Research, NY, USA.'}, {'ForeName': 'Thiago P', 'Initials': 'TP', 'LastName': 'Fernandes', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil. Electronic address: paivatm@gmail.com.'}, {'ForeName': 'Natanael A', 'Initials': 'NA', 'LastName': 'Santos', 'Affiliation': 'Federal University of Paraiba, Department of Psychology, Joao Pessoa, Brazil; Perception, Neuroscience, and Behaviour Laboratory, Joao Pessoa, Brazil.'}]",Psychiatry research,['10.1016/j.psychres.2020.113357']
2871,32823218,Effect of adjunctive single dose parental vitamin D replacement on improving depression ratings in major depression with concurrent vitamin D deficiency: A double-blind randomized placebo-controlled trial.,"Adjunctive vitamin D replacement is a theoretically promising strategy to improve outcomes in major depression. Our objective was to assess the efficacy of a single parenteral dose of vitamin D supplementation at baseline as an adjunct to treatment as usual on change in depression symptom ratings (primary outcome), quality of life and clinical severity of illness (secondary outcomes) at the end of 12 weeks when compared to treatment as usual in patients with major depression and concurrent Vitamin D deficiency. Eligible participants were randomized to receive either treatment as usual (TAU; n = 23) or TAU plus single parenteral dose of 3,00,000 IU of vitamin D (n = 23) at baseline. Rater-blinded assessments of depression (primary outcome), quality of life (QoL) and clinical severity of illness were obtained at baseline, and end of follow-up (12 weeks). Intent-to-treat analyses were performed on the entire randomized sample. The intervention significantly improved depression symptom ratings, quality of life and clinical severity of illness at the end of the treatment phase. These findings indicate that a single parenteral dose (3,00,000 IU) of adjunctive vitamin D replacement at baseline is an effective and well tolerated intervention in major depressive disorder with concurrent Vitamin D deficiency. Additionally, it points to a possible role for vitamin D in the pathophysiology of depression and supports personalized approaches for treatment of major depressive disorder.",2020,"The intervention significantly improved depression symptom ratings, quality of life and clinical severity of illness at the end of the treatment phase.","['major depression with concurrent vitamin D deficiency', 'Eligible participants', 'major depressive disorder with concurrent Vitamin D deficiency', 'patients with major depression and concurrent Vitamin D deficiency']","['adjunctive single dose parental vitamin D replacement', 'vitamin D', 'adjunctive vitamin D replacement', 'TAU plus single parenteral dose of 3,00,000 IU of vitamin D', 'Adjunctive vitamin D replacement', 'vitamin D supplementation', 'placebo']","['depression symptom ratings, quality of life and clinical severity of illness', 'quality of life (QoL) and clinical severity of illness', 'depression ratings', 'depression symptom ratings (primary outcome), quality of life and clinical severity of illness (secondary outcomes']","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.409899,"The intervention significantly improved depression symptom ratings, quality of life and clinical severity of illness at the end of the treatment phase.","[{'ForeName': 'Favaz', 'Initials': 'F', 'LastName': 'Vellekkatt', 'Affiliation': 'Department of Psychiatry, Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: favazvkptaj@gmail.com.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Menon', 'Affiliation': 'Department of Psychiatry, Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: drvmenon@gmail.com.'}, {'ForeName': 'Medha', 'Initials': 'M', 'LastName': 'Rajappa', 'Affiliation': 'Department of Biochemistry, Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: linkmedha@gmail.com.'}, {'ForeName': 'Jayaprakash', 'Initials': 'J', 'LastName': 'Sahoo', 'Affiliation': 'Department of Endocrinology, Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER), Puducherry, 605006, India. Electronic address: jppgi@yahoo.com.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2020.07.037']
2872,32823324,[Abdominoplasty without closed-suction drains: a randomised controlled trial].,"INTRODUCTION


There is insufficient scientific evidence from randomised controlled trials to support the routine use of closed-suction drains in body contouring procedures. The aim of this study was to evaluate cumulative seroma volume, length of hospital stay and complication rates in abdominoplasty patients without drains in direct comparison with a cohort receiving drains.
MATERIAL AND METHODS


Abdominoplasty patients were prospectively randomised in two study groups with (MD) and without (OD) placement of closed-suction drains. Patients with a BMI ≤ 30 kg/m 2  undergoing horizontal or combined horizontal/vertical incision abdominoplasty were included. Scarpa's fascia was preserved during dissection. Exclusion criteria comprised simultaneous liposuction, coagulation disorders and ASA score ≥ 3. Cumulative seroma volume over a four-week follow-up period was assessed as the primary outcome measure. Secondary outcome measures were complications requiring surgical revision and length of hospital stay.
RESULTS


This trial did not identify a statistically significant difference in cumulative seroma volume between the MD (30/53) and OD (23/53) cohorts in 53 patients (M MD  493 ± SD 407 ml; M OD  459 ± SD 624 ml; p = 0.812). However, a significantly shorter average length of hospital stay was observed in the OD population (M MD  5.1 ± SD 1.4 d; M OD  4.2 ± SD 1.5 d; p = 0.023). Complication rates were equal in both study groups (n MD  = 1; n OD  = 1).
CONCLUSION


The results of this trial do not justify routine placement of closed-suction drains in abdominoplasty procedures (horizontal or combined horizontal/vertical incision) in the pre-obese patient cohort (BMI ≤ 30 kg/m 2 ). Drain placement should be evaluated on an individual patient-specific basis.",2020,This trial did not identify a statistically significant difference in cumulative seroma volume between the MD (30/53) and OD (23/53) cohorts in 53 patients (M MD  493 ± SD 407 ml; M OD  459 ± SD 624 ml; p = 0.812).,"['Abdominoplasty patients', 'abdominoplasty patients without drains in direct comparison with a cohort receiving drains', 'Patients with a BMI\u2009≤\u200930\u2009kg']","['MD) and without (OD) placement of closed-suction drains', 'Drain placement', 'm 2  undergoing horizontal or combined horizontal/vertical incision abdominoplasty', 'Abdominoplasty without closed-suction drains', 'abdominoplasty procedures (horizontal or combined horizontal/vertical incision', 'closed-suction drains']","['complications requiring surgical revision and length of hospital stay', 'cumulative seroma volume', 'Cumulative seroma volume', 'cumulative seroma volume, length of hospital stay and complication rates', 'Complication rates', 'average length of hospital stay']","[{'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0441139', 'cui_str': 'Suction drain'}, {'cui': 'C3495845', 'cui_str': 'Drain placement'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0198542', 'cui_str': 'Repair of abdominal wall'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0262627', 'cui_str': 'Seroma'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.216615,This trial did not identify a statistically significant difference in cumulative seroma volume between the MD (30/53) and OD (23/53) cohorts in 53 patients (M MD  493 ± SD 407 ml; M OD  459 ± SD 624 ml; p = 0.812).,"[{'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Anker', 'Affiliation': 'Universitätsklinikum Regensburg Zentrum für Plastische, Hand- und Wiederherstellungschirurgie.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Prantl', 'Affiliation': 'Universitätsklinikum Regensburg Zentrum für Plastische, Hand- und Wiederherstellungschirurgie.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Baringer', 'Affiliation': 'Universitätsklinikum Regensburg Zentrum für Plastische, Hand- und Wiederherstellungschirurgie.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Ruewe', 'Affiliation': 'Universitätsklinikum Regensburg Zentrum für Plastische, Hand- und Wiederherstellungschirurgie.'}, {'ForeName': 'Silvan M', 'Initials': 'SM', 'LastName': 'Klein', 'Affiliation': 'Universitätsklinikum Regensburg Zentrum für Plastische, Hand- und Wiederherstellungschirurgie.'}]","Handchirurgie, Mikrochirurgie, plastische Chirurgie : Organ der Deutschsprachigen Arbeitsgemeinschaft fur Handchirurgie : Organ der Deutschsprachigen Arbeitsgemeinschaft fur Mikrochirurgie der Peripheren Nerven und Gefasse : Organ der V...",['10.1055/a-1170-5345']
2873,32823413,Anti-vascular endothelial growth factor in the treatment of macular edema in epidemic retinitis.,"Purpose


To study efficacy of anti-vascular endothelial growth factor (anti-VEGF) in resolution of macular edema in epidemic retinitis (ER).
Methods


In this retrospective, comparative study, patients diagnosed as ER with central macular thickness (CMT) ≥ 600 μm on SD-OCT at presentation were studied. Eyes which did not receive intravitreal anti-VEGF formed group A and eyes receiving additional anti-VEGF formed group B. Eyes receiving anti-VEGF monotherapy were studied separately. Cases with subsequent OCT scans with interval of more than 20 days and cases without OCT scan at the resolution were excluded. Treatment details, visual outcome, and days to resolution of macular edema were studied.
Results


Mean CMT in group A (n = 8) was 820.1 μm (range 607-1004 μm) and in Group B (n = 4) was 756.0 μm (range 603-1000 μm). Macular edema resolved in 34.8 days (range: 16-65) and 39.0 days (range: 21-45) in group A and B, respectively. Two eyes with anti-VEGF monotherapy recovered in 45 and 18 days, respectively. Mean corrected distance visual acuity (CDVA) at presentation in group A was 19.1 (range: 0-61) ETDRS letters and in group B was 14.3 (range: 0-35) ETDRS letters. Mean CDVA improved to 65.7 (range: 0-85) and 50.8 (range: 20-76) ETDRS letters in group A and B, respectively. Anti-VEGF monotherapy eyes improved from 35 and 46 ETDRS letters to 70 and 85 ETDRS letters, respectively.
Conclusion


Additional anti-VEGF therapy has no added advantage in speed of resolution of macular edema due to ER. A randomized controlled trial with steroids sparing ""anti-VEGF monotherapy"" may verify our observations.",2020,Mean CDVA improved to 65.7 (range: 0-85) and 50.8 (range: 20-76),"['patients diagnosed as ER with central macular thickness (CMT) ≥', 'macular edema in epidemic retinitis (ER', 'macular edema in epidemic retinitis', 'n = 8) was 820.1 μm ']","['intravitreal anti-VEGF formed group A and eyes receiving additional anti-VEGF formed group B. Eyes receiving anti-VEGF monotherapy', 'anti-VEGF monotherapy', 'steroids sparing ""anti-VEGF monotherapy', 'anti-VEGF therapy', 'anti-vascular endothelial growth factor (anti-VEGF', 'Anti-vascular endothelial growth factor']","['Mean CDVA', 'Macular edema', 'Mean corrected distance visual acuity (CDVA', 'visual outcome, and days to resolution of macular edema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C0035333', 'cui_str': 'Retinitis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}]","[{'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C4727875', 'cui_str': 'Anti-vascular endothelial growth factor therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0271051', 'cui_str': 'Macular retinal edema'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0333061,Mean CDVA improved to 65.7 (range: 0-85) and 50.8 (range: 20-76),"[{'ForeName': 'Ankush A', 'Initials': 'AA', 'LastName': 'Kawali', 'Affiliation': 'Department of Uveitis and Ocular Immunology, Narayana Nethralaya, Bengaluru, Karnataka, India.'}, {'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Mohan', 'Affiliation': 'Retina, Narayana Nethralaya, Bengaluru, Karnataka, India.'}, {'ForeName': 'Ruchir', 'Initials': 'R', 'LastName': 'Mehta', 'Affiliation': 'Retina, Narayana Nethralaya, Bengaluru, Karnataka, India.'}, {'ForeName': 'Padmamalini', 'Initials': 'P', 'LastName': 'Mahendradas', 'Affiliation': 'Department of Uveitis and Ocular Immunology, Narayana Nethralaya, Bengaluru, Karnataka, India.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Uveitis and Ocular Immunology, Narayana Nethralaya, Bengaluru, Karnataka, India.'}, {'ForeName': 'Bhujang', 'Initials': 'B', 'LastName': 'Shetty', 'Affiliation': 'General Ophthalmology, Narayana Nethralaya, Bengaluru, Karnataka, India.'}]",Indian journal of ophthalmology,['10.4103/ijo.IJO_439_20']
2874,32823504,Different Effects of Transcranial Direct Current Stimulation on Leg Muscle Glucose Uptake Asymmetry in Two Women with Multiple Sclerosis.,"Asymmetrical lower limb strength is a significant contributor to impaired walking abilities in people with multiple sclerosis (PwMS). Transcranial direct current stimulation (tDCS) may be an effective technique to enhance cortical excitability and increase neural drive to more-affected lower limbs. A sham-controlled, randomized, cross-over design was employed. Two women with MS underwent two 20 min sessions of either 3 mA tDCS or Sham before 20 min of treadmill walking at a self-selected speed. During walking, the participants were injected with the glucose analogue, [ 18 F] fluorodeoxyglucose (FDG). Participants were then imaged to examine glucose metabolism and uptake asymmetries in the legs. Standardized uptake values (SUVs) were compared between the legs and asymmetry indices were calculated. Subject 2 was considered physically active (self-reported participating in at least 30 min of moderate-intensity physical activity on at least three days of the week for the last three months), while Subject 1 was physically inactive. In Subject 1, there was a decrease in SUVs at the left knee flexors, left upper leg, left and right plantar flexors, and left and right lower legs and SUVs in the knee extensors and dorsiflexors were considered symmetric after tDCS compared to Sham. Subject 2 showed an increase in SUVs at the left and right upper legs, right plantar flexors, and right lower leg with no muscle group changing asymmetry status. This study demonstrates that tDCS may increase neural drive to leg muscles and decrease glucose uptake during walking in PwMS with low physical activity levels.",2020,"Subject 2 showed an increase in SUVs at the left and right upper legs, right plantar flexors, and right lower leg with no muscle group changing asymmetry status.","['Two Women with Multiple Sclerosis', 'people with multiple sclerosis (PwMS', 'Two women with MS']","['Transcranial Direct Current Stimulation', 'Transcranial direct current stimulation (tDCS', '3 mA tDCS or Sham before 20 min of treadmill walking at a self-selected speed', 'tDCS']","['Leg Muscle Glucose Uptake Asymmetry', 'Standardized uptake values (SUVs', 'SUVs at the left and right upper legs, right plantar flexors, and right lower leg', 'SUVs at the left knee flexors, left upper leg, left and right plantar flexors, and left and right lower legs and SUVs']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]","[{'cui': 'C0224456', 'cui_str': 'Skeletal muscle structure of lower leg'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0230442', 'cui_str': 'Structure of right lower leg'}, {'cui': 'C4281599', 'cui_str': 'Structure of left knee region'}, {'cui': 'C0205091', 'cui_str': 'Left'}]",2.0,0.030917,"Subject 2 showed an increase in SUVs at the left and right upper legs, right plantar flexors, and right lower leg with no muscle group changing asymmetry status.","[{'ForeName': 'Alexandra C', 'Initials': 'AC', 'LastName': 'Fietsam', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Craig D', 'Initials': 'CD', 'LastName': 'Workman', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, Iowa City, IA 52242, USA.'}, {'ForeName': 'Laura L Boles', 'Initials': 'LLB', 'LastName': 'Ponto', 'Affiliation': 'Department of Radiology, University of Iowa Hospitals and Clinics, Iowa City, IA 52242, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kamholz', 'Affiliation': 'Department of Neurology, University of Iowa Hospitals and Clinics, Iowa City, IA 52242, USA.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Rudroff', 'Affiliation': 'Department of Health and Human Physiology, University of Iowa, Iowa City, IA 52242, USA.'}]",Brain sciences,['10.3390/brainsci10080549']
2875,32823519,On Performance and Perceived Effort in Trail Runners Using Sensor Control to Generate Biosynchronous Music.,"Music has been shown to be capable of improving runners' performance in treadmill and laboratory-based experiments. This paper evaluates a generative music system, namely HEARTBEATS, designed to create biosignal synchronous music in real-time according to an individual athlete's heartrate or cadence (steps per minute). The tempo, melody, and timbral features of the generated music are modulated according to biosensor input from each runner using a combination of PPG (Photoplethysmography) and GPS (Global Positioning System) from a wearable sensor, synchronized via Bluetooth. We compare the relative performance of athletes listening to music with heartrate and cadence synchronous tempos, across a randomized trial (N = 54) on a trail course with 76 ft of elevation. Participants were instructed to continue until their self-reported perceived effort went beyond an 18 using the Borg rating of perceived exertion. We found that cadence-synchronous music improved performance and decreased perceived effort in male runners. For female runners, cadence synchronous music improved performance but it was heartrate synchronous music which significantly reduced perceived effort and allowed them to run the longest of all groups tested. This work has implications for the future design and implementation of novel portable music systems and in music-assisted coaching.",2020,"For female runners, cadence synchronous music improved performance but it was heartrate synchronous music which significantly reduced perceived effort and allowed them to run the longest of all groups tested.","['male runners', 'Trail Runners Using Sensor Control to Generate Biosynchronous Music']",['athletes listening to music with heartrate and cadence synchronous tempos'],[],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}]",[],,0.175,"For female runners, cadence synchronous music improved performance but it was heartrate synchronous music which significantly reduced perceived effort and allowed them to run the longest of all groups tested.","[{'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Williams', 'Affiliation': 'School of Computing, Science & Engineering, the University of Salford, the Crescent, Salford M5 4WT, UK.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Fazenda', 'Affiliation': 'School of Computing, Science & Engineering, the University of Salford, the Crescent, Salford M5 4WT, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Williamson', 'Affiliation': 'Lucerne University of Applied Sciences and Arts, 6002 Luzern, Switzerland.'}, {'ForeName': 'György', 'Initials': 'G', 'LastName': 'Fazekas', 'Affiliation': 'School of Electronic Engineering and Computer Science, Queen Mary University of London, London E1 4FZ, UK.'}]","Sensors (Basel, Switzerland)",['10.3390/s20164528']
2876,32823594,Effects of  CYP1A2  and  ADORA2A  Genotypes on the Ergogenic Response to Caffeine in Professional Handball Players.,"Previous investigations have found that several genes may be associated with the interindividual variability to the ergogenic response to caffeine. The aim of this study is to analyze the influence of the genetic variations in  CYP1A2  (-163C  > A, rs762551; characterized such as ""fast"" (AA genotype) and ""slow"" caffeine metabolizers (C-carriers)) and  ADORA2A  (1976T  > C; rs5751876; characterized by ""high"" (TT genotype) or ""low"" sensitivity to caffeine (C-carriers)) on the ergogenic response to acute caffeine intake in professional handball players. Thirty-one professional handball players (sixteen men and fifteen women; daily caffeine intake = 60 ± 25 mg·d -1 ) ingested 3 mg·kg -1 ·body mass (bm) of caffeine or placebo 60 min before undergoing a battery of performance tests consisting of a countermovement jump (CMJ), a sprint test, an agility test, an isometric handgrip test, and several ball throws. Afterwards, the handball players performed a simulated handball match (2 × 20 min) while movements were recorded using inertial units. Saliva samples were analyzed to determine the genotype of each player for the -163C  > A polymorphism in the  CYP1A2  gene (rs762551) and for the 1976T  > C polymorphism in the  ADORA2A  gene (rs5751876). In the  CYP1A2 , C-allele carriers (54.8%) were compared to AA homozygotes (45.2%). In the  ADORA2A , C-allele carriers (80.6%) were compared to TT homozygotes (19.4%). There was only a genotype x treatment interaction for the ball throwing from 7 m ( p  = 0.037) indicating that the ergogenic effect of caffeine on this test was higher in  CYP1A2  AA homozygotes than in C-allele carriers. In the remaining variables, there were no genotype x treatment interactions for  CYP1A2  or for  ADORA2A . As a whole group, caffeine increased CMJ height, performance in the sprint velocity test, and ball throwing velocity from 9 m (2.8-4.3%,  p  = 0.001-0.022, effect size = 0.17-0.31). Thus, pre-exercise caffeine supplementation at a dose of 3 mg·kg -1 ·bm can be considered as an ergogenic strategy to enhance some neuromuscular aspects of handball performance in professional handball players with low daily caffeine consumption. However, the ergogenic response to acute caffeine intake was not modulated by  CYP1A2  or  ADORA2A  genotypes.",2020,There was only a genotype x treatment interaction for the ball throwing from 7 m ( p  = 0.037) indicating that the ergogenic effect of caffeine on this test was higher in  CYP1A2  AA homozygotes than in C-allele carriers.,"['professional handball players', 'Professional Handball Players', 'Thirty-one professional handball players (sixteen men and fifteen women; daily caffeine intake = 60 ± 25 mg·d -1 ) ingested 3 mg·kg -1 ·body mass (bm) of', 'professional handball players with low daily caffeine consumption']","['caffeine', 'Caffeine', 'high"" (TT genotype) or ""low"" sensitivity to caffeine (C-carriers', 'countermovement jump (CMJ), a sprint test, an agility test, an isometric handgrip test, and several ball throws', 'caffeine or placebo']","['genotype x treatment interaction', 'CMJ height, performance in the sprint velocity test, and ball throwing velocity']","[{'cui': 'C0336936', 'cui_str': 'Handball'}, {'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}]",,0.0565286,There was only a genotype x treatment interaction for the ball throwing from 7 m ( p  = 0.037) indicating that the ergogenic effect of caffeine on this test was higher in  CYP1A2  AA homozygotes than in C-allele carriers.,"[{'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Muñoz', 'Affiliation': 'Exercise and Sport Sciences, Faculty of Health Sciences, Universidad Francisco de Vitoria, 28223 Madrid, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'López-Samanes', 'Affiliation': 'Exercise Physiology Group, School of Physiotherapy, Faculty of Health Sciences, Universidad Francisco Vitoria, 28223 Madrid, Spain.'}, {'ForeName': 'Millán', 'Initials': 'M', 'LastName': 'Aguilar-Navarro', 'Affiliation': 'Exercise and Sport Sciences, Faculty of Health Sciences, Universidad Francisco de Vitoria, 28223 Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Varillas-Delgado', 'Affiliation': 'Faculty of Medicine, Research Unit, Universidad Francisco de Vitoria, 28223 Pozuelo de Alarcon, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Rivilla-García', 'Affiliation': 'Faculty of Physical Activity and Sports Sciences (INEF), Universidad Politécnica de Madrid (UPM), 28040 Madrid, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Moreno-Pérez', 'Affiliation': 'Sports Research Centre, Miguel Hernandez University of Elche, 03202 Alicante, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Del Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, 28943 Fuenlabrada, Madrid, Spain.'}]",Genes,['10.3390/genes11080933']
2877,32823599,Displacing Sedentary Behaviour with Light Intensity Physical Activity Spontaneously Alters Habitual Macronutrient Intake and Enhances Dietary Quality in Older Females.,"Displacing Sedentary Behaviour (SB) with light intensity physical activity (LIPA) is increasingly viewed as a viable means of health enhancement. It is, however, unclear whether any behavioural compensations accompany such an intervention. Therefore, the aim of this study was to identify any dietary changes that accompany SB displacement. We hypothesised that SB displacement would improve dietary quality. Thirty-five elderly females (73 ± 5 years) were randomly allocated to one of three groups: (1) sedentary behaviour fragmentation (SBF) ( n  = 14), (2) continuous LIPA ( n  = 14), or (3) control ( n  = 7). Habitual diet (four-day food diary) and physical behaviour (accelerometery) were assessed at weeks 0 and 8. Out of 45 nutrients examined, only glucose exhibited a group × time interaction ( p  = 0.03), mediated by an exclusive reduction following SBF (-31%). SBF was also the sole experimental group to increase nutrients promoting bone health (SBF: 17%, LIPA: -34%. control: 21%), whereas both experimental groups consumed more nutrients promoting anabolism (SBF: 13%, LIPA: 4%, control: -34%) (z-scores). New ambulators ( n  = 8) also consumed more nutrients promoting bone health (16%)/anabolism (2%) (z-scores), including significantly increased Zinc intake ( p  = 0.05, 29%). Displacing SB with LIPA improves dietary quality in older females. Furthermore, SB fragmentation appears advantageous for various dietary outcomes.",2020,"New ambulators ( n  = 8) also consumed more nutrients promoting bone health (16%)/anabolism (2%) (z-scores), including significantly increased Zinc intake ( p  = 0.05, 29%).","['older females', 'Thirty-five elderly females (73 ± 5 years', 'Older Females']","['Displacing SB with LIPA', 'Light Intensity Physical Activity Spontaneously Alters Habitual Macronutrient Intake', 'Displacing Sedentary Behaviour (SB) with light intensity physical activity (LIPA', 'LIPA', 'sedentary behaviour fragmentation (SBF', 'SB displacement', 'continuous LIPA', 'SBF']","['nutrients promoting anabolism', 'nutrients promoting bone health (16%)/anabolism', 'dietary quality', 'nutrients promoting bone health', 'Zinc intake']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332472', 'cui_str': 'Fragmentation'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0005572', 'cui_str': 'bioformation'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0564449', 'cui_str': 'Zinc intake'}]",35.0,0.0197407,"New ambulators ( n  = 8) also consumed more nutrients promoting bone health (16%)/anabolism (2%) (z-scores), including significantly increased Zinc intake ( p  = 0.05, 29%).","[{'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Grant', 'Affiliation': 'Research Centre for Musculoskeletal Science and Sports Medicine, Department of Sports and Exercise Sciences, Manchester Metropolitan University, Manchester M15 6BH, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tomlinson', 'Affiliation': 'Research Centre for Musculoskeletal Science and Sports Medicine, Department of Sports and Exercise Sciences, Manchester Metropolitan University, Manchester M15 6BH, UK.'}, {'ForeName': 'Kostas', 'Initials': 'K', 'LastName': 'Tsintzas', 'Affiliation': ""School of Life Sciences, Faculty of Medicine & Health Sciences, The University of Nottingham Medical School, Queen's Medical Centre, Nottingham NG7 2UH, UK.""}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Kolic', 'Affiliation': 'Research Centre for Musculoskeletal Science and Sports Medicine, Department of Sports and Exercise Sciences, Manchester Metropolitan University, Manchester M15 6BH, UK.'}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Onambele-Pearson', 'Affiliation': 'Research Centre for Musculoskeletal Science and Sports Medicine, Department of Sports and Exercise Sciences, Manchester Metropolitan University, Manchester M15 6BH, UK.'}]",Nutrients,['10.3390/nu12082431']
2878,32823606,Multiple Micronutrients and Docosahexaenoic Acid Supplementation during Pregnancy: A Randomized Controlled Study.,"Maternal dietary intake during pregnancy needs to meet increased nutritional demands to maintain metabolism and to support fetal development. Docosahexaenoic acid (DHA) is essential for fetal neuro-/visual development and in immunomodulation, accumulating rapidly within the developing brain and central nervous system. Levels available to the fetus are governed by the maternal diet. In this multicenter, parallel, randomized controlled trial, we evaluated once-daily supplementation with multiple micronutrients and DHA (i.e., multiple micronutrient supplementation, MMS) on maternal biomarkers and infant anthropometric parameters during the second and third trimesters of pregnancy compared with no supplementation. Primary efficacy endpoint: change in maternal red blood cell (RBC) DHA ( wt % total fatty acids) during the study. Secondary variables: other biomarkers of fatty acid and oxidative status, vitamin D, and infant anthropometric parameters at delivery. Supplementation significantly increased RBC DHA levels, the omega-3 index, and vitamin D levels. Subscapular skinfold thickness was significantly greater with MMS in infants. Safety outcomes were comparable between groups. This first randomized controlled trial of supplementation with multiple micronutrients and DHA in pregnant women indicated that MMS significantly improved maternal DHA and vitamin D status in an industrialized setting-an important finding considering the essential roles of DHA and vitamin D.",2020,"Supplementation significantly increased RBC DHA levels, the omega-3 index, and vitamin D levels.","['during Pregnancy', 'pregnant women']","['Docosahexaenoic Acid Supplementation', 'MMS', 'multiple micronutrients and DHA (i.e., multiple micronutrient supplementation, MMS', 'Docosahexaenoic acid (DHA']","['Safety outcomes', 'Subscapular skinfold thickness', 'maternal DHA and vitamin D status', 'maternal red blood cell (RBC) DHA ( wt % total fatty acids', 'Maternal dietary intake', 'maternal biomarkers and infant anthropometric parameters', 'biomarkers of fatty acid and oxidative status, vitamin D, and infant anthropometric parameters at delivery', 'RBC DHA levels, the omega-3 index, and vitamin D levels']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0556102', 'cui_str': 'Docosahexaenoic acid supplementation'}, {'cui': 'C0025706', 'cui_str': 'Methylmesilate'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0037302', 'cui_str': 'Skinfold Thickness'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0439175', 'cui_str': '% of total'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0829976,"Supplementation significantly increased RBC DHA levels, the omega-3 index, and vitamin D levels.","[{'ForeName': 'Maddalena', 'Initials': 'M', 'LastName': 'Massari', 'Affiliation': 'Department of Woman, Mother and Neonate, Buzzi Children Hospital, ASST Fatebenefratelli Sacco, 20154 Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Novielli', 'Affiliation': '""Luigi Sacco"" Department of Biomedical and Clinical Sciences, Università Degli Studi di Milano, 20157 Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Mandò', 'Affiliation': '""Luigi Sacco"" Department of Biomedical and Clinical Sciences, Università Degli Studi di Milano, 20157 Milan, Italy.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Di Francesco', 'Affiliation': 'Department of Woman, Mother and Neonate, Buzzi Children Hospital, ASST Fatebenefratelli Sacco, 20154 Milan, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Della Porta', 'Affiliation': '""Luigi Sacco"" Department of Biomedical and Clinical Sciences, Università Degli Studi di Milano, 20157 Milan, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Cazzola', 'Affiliation': '""Luigi Sacco"" Department of Biomedical and Clinical Sciences, Università Degli Studi di Milano, 20157 Milan, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Panteghini', 'Affiliation': '""Luigi Sacco"" Department of Biomedical and Clinical Sciences, Università Degli Studi di Milano, 20157 Milan, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Savasi', 'Affiliation': 'Department of Woman, Mother and Neonate, Luigi Sacco Hospital, ASST Fatebenefratelli Sacco, 20157 Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Maggini', 'Affiliation': 'Bayer Consumer Care AG, 4002 Basel, Switzerland.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Schaefer', 'Affiliation': 'Bayer Consumer Care AG, 4002 Basel, Switzerland.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Cetin', 'Affiliation': 'Department of Woman, Mother and Neonate, Buzzi Children Hospital, ASST Fatebenefratelli Sacco, 20154 Milan, Italy.'}]",Nutrients,['10.3390/nu12082432']
2879,32823682,Antibiotics Effects on the Fecal Metabolome in Preterm Infants.,"Within a randomized prospective pilot study of preterm infants born at less than 33 weeks' gestation, weekly fecal samples from 19 infants were collected and metabolomic analysis was performed. The objective was to evaluate for differences in fecal metabolites in infants exposed to antibiotics vs. not exposed to antibiotics in the first 48 h after birth. Metabolomics analysis was performed on 123 stool samples. Significant differences were seen in the antibiotics vs. no antibiotics groups, including pathways related to vitamin biosynthesis, bile acids, amino acid metabolism, and neurotransmitters. Early antibiotic exposure in preterm infants may alter metabolites in the intestinal tract of preterm infants. Broader multi-omic studies that address mechanisms will guide more prudent antibiotic use in this population.",2020,"Significant differences were seen in the antibiotics vs. no antibiotics groups, including pathways related to vitamin biosynthesis, bile acids, amino acid metabolism, and neurotransmitters.","[""preterm infants born at less than 33 weeks' gestation, weekly fecal samples from 19 infants"", 'Preterm Infants', 'preterm infants']",[],"['vitamin biosynthesis, bile acids, amino acid metabolism, and neurotransmitters', 'fecal metabolites', 'Fecal Metabolome']","[{'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]",[],"[{'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0005572', 'cui_str': 'bioformation'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0027908', 'cui_str': 'Neurotransmitter'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C2350399', 'cui_str': 'Metabolome'}]",19.0,0.127272,"Significant differences were seen in the antibiotics vs. no antibiotics groups, including pathways related to vitamin biosynthesis, bile acids, amino acid metabolism, and neurotransmitters.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Patton', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL 32610-0296, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL 32610-0296, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Garrett', 'Affiliation': 'Department of Pathology, Immunology and Laboratory Medicine, College of Medicine, University of Florida, Gainesville, FL 32610, USA.'}, {'ForeName': 'J Lauren', 'Initials': 'JL', 'LastName': 'Ruoss', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL 32610-0296, USA.'}, {'ForeName': 'Jordan T', 'Initials': 'JT', 'LastName': 'Russell', 'Affiliation': 'Department of Microbiology and Cell Science, Institute of Food and Agricultural Sciences, University of Florida, Gainesville, FL 32603, USA.'}, {'ForeName': 'Diomel', 'Initials': 'D', 'LastName': 'de la Cruz', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL 32610-0296, USA.'}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'Bazacliu', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL 32610-0296, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Polin', 'Affiliation': 'Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA.'}, {'ForeName': 'Eric W', 'Initials': 'EW', 'LastName': 'Triplett', 'Affiliation': 'Department of Microbiology and Cell Science, Institute of Food and Agricultural Sciences, University of Florida, Gainesville, FL 32603, USA.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Neu', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, University of Florida, Gainesville, FL 32610-0296, USA.'}]",Metabolites,['10.3390/metabo10080331']
2880,32823720,Comparison of Opioid-Free Anesthesia Versus Opioid-Containing Anesthesia for Elective Laparoscopic Surgery (COFA: LAP): A Protocol Measuring Recovery Outcomes.,"The administration of opioids is a central element in contemporary anesthetic techniques in Australia; however, opioids have a range of side effects. As an alternative, opioid-free anesthesia (OFA) is an emerging mode of anesthesia intended to avoid these side effects. This study is the first to publish the use of OFA in Australia and is conducted in a regional Queensland Health Service. The design will utilize a randomized clinical trial (RCT) to investigate the impact of OFA for patients having an elective laparoscopic cholecystectomy ( n  = 40) or tubal ligation ( n  = 40). Participant outcomes to be measured include: Quality of Recovery (QoR-15); Oral Morphine Equivalent Daily Dose (OMEDD) at 24-h post-operatively; time to first opioid (TTFO) dose; post-operative nausea and vomiting (PONV); Post Anesthetic Care Unit length of stay (PACU-LOS); and hospital length of stay (LOS). The findings may challenge the essentiality of opioids in the peri-operative period, which in turn would influence the future intra-operative management of surgical patients. Ultimately, a reduction in anesthesia-associated opioid use will support a more general decline in opioid use.",2020,The design will utilize a randomized clinical trial (RCT) to investigate the impact of OFA for patients having an elective laparoscopic cholecystectomy ( n  = 40) or tubal ligation ( n  = 40).,['patients having an elective laparoscopic cholecystectomy ( n  = 40) or tubal ligation ( n  = 40'],"['Opioid-Containing Anesthesia', 'opioids', 'opioid-free anesthesia (OFA', 'OFA', 'COFA: LAP', 'Elective Laparoscopic Surgery', 'Opioid-Free Anesthesia']",[' Quality of Recovery (QoR-15); Oral Morphine Equivalent Daily Dose (OMEDD) at 24-h post-operatively; time to first opioid (TTFO) dose; post-operative nausea and vomiting (PONV); Post Anesthetic Care Unit length of stay (PACU-LOS); and hospital length of stay (LOS'],"[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0520483', 'cui_str': 'Ligation of fallopian tube'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0360457', 'cui_str': 'Morphine-containing product in oral dose form'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}]",,0.0797404,The design will utilize a randomized clinical trial (RCT) to investigate the impact of OFA for patients having an elective laparoscopic cholecystectomy ( n  = 40) or tubal ligation ( n  = 40).,"[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Eidan', 'Affiliation': 'Anesthetic Department, Bundaberg Hospital, Wide Bay Hospital and Health Service, Bundaberg 4670, Australia.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ratsch', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Queensland, Brisbane 4072, Australia.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Burmeister', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Queensland, Brisbane 4072, Australia.'}, {'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Griffiths', 'Affiliation': 'School of Nursing, Midwifery and Social Work, The University of Queensland, Brisbane 4072, Australia.'}]",Methods and protocols,['10.3390/mps3030058']
2881,32823733,No Effects of New Zealand Blackcurrant Extract on Physiological and Performance Responses in Trained Male Cyclists Undertaking Repeated Testing across a Week Period.,"Anthocyanin supplements are receiving attention due to purported benefits to physiological, metabolic, and exercise responses in trained individuals. However, the efficacy of anthocyanin intake over multiple testing days is not known. We compared a placebo and two doses of anthocyanin-rich New Zealand blackcurrant (NZBC) extract (300 and 600 mg·day -1 ) on plasma lactate, substrate oxidation, and 16.1 km time trial (TT) performance on three occasions over 7-days in a fed state (day 1 (D1), D4, and D7). Thirteen male cyclists participated in a randomized, crossover, placebo-controlled double-blind design. There was no difference in plasma lactate and substrate oxidation between conditions and between days. A time difference was observed between D1 (1701 ± 163 s) and D4 (1682 ± 162 s) for 600 mg ( p  = 0.05), with an increment in average speed (D1 = 34.3 ± 3.4 vs. D4 = 34.8 ± 3.4 km·h -1 ,  p  = 0.04). However, there was no difference between the other days and between conditions. Overall, one week of intake of NZBC extract did not affect physiological and metabolic responses. Intake of 600 mg of NZBC extract showed inconsistent benefits in improving 16.1 km time trial performance over a week period in trained fed cyclists.",2020,Intake of 600 mg of NZBC extract showed inconsistent benefits in improving 16.1 km time trial performance over a week period in trained fed cyclists.,"['Trained Male Cyclists', 'Thirteen male cyclists']","['New Zealand Blackcurrant Extract', 'Anthocyanin supplements', 'NZBC extract', 'anthocyanin-rich New Zealand blackcurrant (NZBC) extract', 'placebo']","['Physiological and Performance Responses', 'physiological and metabolic responses', 'plasma lactate, substrate oxidation, and 16.1 km time trial (TT) performance', 'plasma lactate and substrate oxidation']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715149', 'cui_str': '13'}]","[{'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C4319689', 'cui_str': '16.1'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",13.0,0.300606,Intake of 600 mg of NZBC extract showed inconsistent benefits in improving 16.1 km time trial performance over a week period in trained fed cyclists.,"[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Montanari', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Mehmet A', 'Initials': 'MA', 'LastName': 'Şahin', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Ben J', 'Initials': 'BJ', 'LastName': 'Lee', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Sam D', 'Initials': 'SD', 'LastName': 'Blacker', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}, {'ForeName': 'Mark E T', 'Initials': 'MET', 'LastName': 'Willems', 'Affiliation': 'Institute of Sport, University of Chichester, College Lane, Chichester PO19 6PE, UK.'}]","Sports (Basel, Switzerland)",['10.3390/sports8080114']
2882,32823771,"Mobile-Based Lifestyle Intervention in Women with Glucose Intolerance after Gestational Diabetes Mellitus (MELINDA), A Multicenter Randomized Controlled Trial: Methodology and Design.","The aims of the 'Mobile-based lifestyle intervention in women with glucose intolerance after gestational diabetes mellitus (GDM)' study (MELINDA) are: (1) to evaluate the prevalence and risk factors of glucose intolerance after a recent history of GDM; and (2) to evaluate the efficacy and feasibility of a telephone- and mobile-based lifestyle intervention in women with glucose intolerance after GDM. This is a Belgian multicenter randomized controlled trial (RCT) in seven hospitals with the aim of recruiting 236 women. Women in the intervention group will receive a blended program, based on one face-to-face education session and further follow-up through a mobile application and monthly telephone advice. Women in the control group will receive follow-up as in normal routine with referral to primary care. Participants will receive an oral glucose tolerance test (OGTT) one year after baseline. Primary endpoint is the frequency of weight goal achievement (≥5% weight loss if pre-pregnancy BMI ≥ 25 Kg/m 2  or return to pre-gravid weight if BMI < 25 Kg/m 2 ). At each visit blood samples are collected, anthropometric measurements are obtained, and self-administered questionnaires are completed. Recruitment began in May 2019.",2020,< 25 Kg,"['Women with Glucose Intolerance after Gestational Diabetes Mellitus', ' 25 Kg', 'women with glucose intolerance after GDM', 'seven hospitals with the aim of recruiting 236 women', 'women with glucose intolerance after gestational diabetes mellitus (GDM']","['blended program, based on one face-to-face education session and further follow-up through a mobile application and monthly telephone advice', 'oral glucose tolerance test (OGTT', 'Mobile-based lifestyle intervention', 'telephone- and mobile-based lifestyle intervention', 'Mobile-Based Lifestyle Intervention']",['frequency of weight goal achievement (≥5% weight loss if pre-pregnancy BMI ≥'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2744535', 'cui_str': 'CD69 protein, human'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",236.0,0.0914501,< 25 Kg,"[{'ForeName': 'Caro', 'Initials': 'C', 'LastName': 'Minschart', 'Affiliation': 'Clinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Toon', 'Initials': 'T', 'LastName': 'Maes', 'Affiliation': 'Department of Endocrinology, Imelda Hospital, 2820 Bonheiden, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'De Block', 'Affiliation': 'Department of Endocrinology-Diabetology-Metabolism, Antwerp University Hospital, 2650 Edegem, Belgium.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Van Pottelbergh', 'Affiliation': 'Department of Endocrinology, OLV Hospital Aalst, 9300 Aalst, Belgium.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Myngheer', 'Affiliation': 'Department of Endocrinology, General Hospital Groeninge, 8510 Kortrijk, Belgium.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Department of Endocrinology, GZA Hospital Sint-Vincentius, 2018 Antwerp, Belgium.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Vinck', 'Affiliation': 'Department of Endocrinology, GZA Hospital Sint-Augustinus, 2610 Wilrijk, Belgium.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Leuridan', 'Affiliation': 'Department of Endocrinology, General Hospital Klina, 2930 Brasschaat, Belgium.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Mathieu', 'Affiliation': 'Clinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Jaak', 'Initials': 'J', 'LastName': 'Billen', 'Affiliation': 'Department of Laboratory Medicine, University Hospitals Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Matthys', 'Affiliation': 'Clinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Babs', 'Initials': 'B', 'LastName': 'Weyn', 'Affiliation': 'Department of Electrical Engineering, Processing Speech and Images, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Annouschka', 'Initials': 'A', 'LastName': 'Laenen', 'Affiliation': 'Centre of Biostatics and Statistical Bioinformatics, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Bogaerts', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, 3000 Leuven, Belgium.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'Benhalima', 'Affiliation': 'Clinical and Experimental Endocrinology, Department of Chronic Diseases and Metabolism, KU Leuven, 3000 Leuven, Belgium.'}]",Journal of clinical medicine,['10.3390/jcm9082635']
2883,32823828,Physical Fitness Promotion among Adolescents: Effects of a Jump Rope-Based Physical Activity Afterschool Program.,"The major purpose of this study was to examine the effects of a jump rope-based physical activity afterschool program on middle school students' physical fitness. Sixty students ( M age  = 13.37,  SD  = 0.58; 53.3% female) participated in a 12-week jump rope-based afterschool program (45 min/time, three times/week). Participants were randomly assigned to three groups: (a) freestyle rope skipping ( N  = 20), traditional jump rope ( N  = 20), and a control group ( N  = 20). Physical fitness tests, including muscular strength (standing long jump, right-hand grip, and left-hand grip), flexibility, body composition, and bone mineral density (BMD) were measured in pre- and post-tests. A 2 (time) × 3 (groups) repeated measure multivariate analysis of variance (MANOVA) was performed. The results found significant improvements in muscular strength (standing long jump, right-hand grip, and left-hand grip) in both intervention groups ( p  < 0.001;  d s = 0.2-0.44). Only the freestyle rope skipping group had increased BMD ( p  < 0.05,  d  = 0.33). Compared to the traditional jump rope, the freestyle rope skipping group showed significantly higher improvement in flexibility ( p  < 0.05,  d  = 0.83). These findings suggest that the jump rope-based afterschool program with freestyle rope skipping would be more effective than traditional jump rope to promote physical fitness performance among adolescents.",2020,"The results found significant improvements in muscular strength (standing long jump, right-hand grip, and left-hand grip) in both intervention groups ( p  < 0.001;  d s = 0.2-0.44).","[""middle school students' physical fitness"", 'Adolescents', 'adolescents', 'Sixty students ( M age  = 13.37,  SD  = 0.58; 53.3% female']","['freestyle rope skipping ( N  = 20), traditional jump rope', 'Jump Rope-Based Physical Activity Afterschool Program', 'jump rope-based afterschool program', 'jump rope-based physical activity afterschool program']","['flexibility', 'Physical fitness tests, including muscular strength (standing long jump, right-hand grip, and left-hand grip), flexibility, body composition, and bone mineral density (BMD', 'muscular strength (standing long jump, right-hand grip, and left-hand grip', 'BMD']","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517463', 'cui_str': '0.58'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0560435', 'cui_str': 'Does skip'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0230370', 'cui_str': 'Structure of right hand'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",60.0,0.0137646,"The results found significant improvements in muscular strength (standing long jump, right-hand grip, and left-hand grip) in both intervention groups ( p  < 0.001;  d s = 0.2-0.44).","[{'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'School of Leisure Sport, Shanghai University of Sport, Shanghai 200438, China.'}, {'ForeName': 'Joonyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Kinesiology, Health Promotion and Recreation, University of North Texas, Denton, TX 76203, USA.'}, {'ForeName': 'Xiangli', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Department of Kinesiology, University of Texas at Arlington, Arlington, TX 76019, USA.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Kinesiology, University of Texas at Arlington, Arlington, TX 76019, USA.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Kinesiology, Health Promotion and Recreation, University of North Texas, Denton, TX 76203, USA.'}]","Children (Basel, Switzerland)",['10.3390/children7080095']
2884,32823850,Tunnel/Pouch versus Coronally Advanced Flap Combined with a Connective Tissue Graft for the Treatment of Maxillary Gingival Recessions: Four-Year Follow-Up of a Randomized Controlled Trial.,"BACKGROUND


The long-term stability after soft tissue graft for covering gingival recession remains a pivotal goal for both patient and periodontist. Therefore, the aim of this study was to compare the four-year outcomes of the coronally advanced flap (CAF) versus the pouch/tunnel (POT) technique, both combined with connective tissue graft (CTG), for gingival recession treatment.
METHODS


Forty patients were initially randomly assigned to the control group (CAF + CTG; N = 20) and the test group (POT + CTG; N = 20). Clinical outcomes included mean root coverage (MRC) and complete root coverage (CRC), gingival thickness (GT), and keratinized tissue (KT) gain. Esthetic outcomes were also analyzed using the pink esthetic score (PES) and patient-reported outcome measures (PROMs). All outcomes initially assessed at six months were extended to four years post-surgery.
RESULTS


No significant differences were observed between the two patient groups in terms of MRC and CRC. At four years, significantly greater GT and KT gain were noted in the POT + CTG group, and tissue texture enhancement was also more prominent in the test group.
CONCLUSIONS


The POT + CTG technique allows for long-term clinical coverage of gingival recessions comparable to that of the CAF + CTG technique, but it potentially improves gingival thickness, keratinized tissue and esthetic results.",2020,"At four years, significantly greater GT and KT gain were noted in the POT + CTG group, and tissue texture enhancement was also more prominent in the test group.
","['Maxillary Gingival Recessions', 'Forty patients']","['POT + CTG', 'Tunnel/Pouch versus Coronally Advanced Flap Combined with a Connective Tissue Graft', 'POT + CTG technique', 'coronally advanced flap (CAF) versus the pouch/tunnel (POT) technique, both combined with connective tissue graft (CTG', 'control group (CAF + CTG']","['tissue texture enhancement', 'MRC and CRC', 'pink esthetic score (PES) and patient-reported outcome measures (PROMs', 'GT and KT gain', 'mean root coverage (MRC) and complete root coverage (CRC), gingival thickness (GT), and keratinized tissue (KT) gain', 'gingival thickness, keratinized tissue and esthetic results']","[{'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4319584', 'cui_str': 'Pouch'}, {'cui': 'C0337138', 'cui_str': 'Tunnel'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",40.0,0.052694,"At four years, significantly greater GT and KT gain were noted in the POT + CTG group, and tissue texture enhancement was also more prominent in the test group.
","[{'ForeName': 'Souheil', 'Initials': 'S', 'LastName': 'Salem', 'Affiliation': 'Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, 4000 Liege, Belgium.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Salhi', 'Affiliation': 'Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, 4000 Liege, Belgium.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Seidel', 'Affiliation': 'Biostatistics and Medico-Economic Information, University Hospital of Liège, 4000 Liège, Belgium.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Lecloux', 'Affiliation': 'Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, 4000 Liege, Belgium.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rompen', 'Affiliation': 'Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, 4000 Liege, Belgium.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Lambert', 'Affiliation': 'Department of Periodontology and Oral Surgery, Faculty of Medicine, University of Liège, 4000 Liege, Belgium.'}]",Journal of clinical medicine,['10.3390/jcm9082641']
2885,32823886,A High Polyphenol Diet Improves Psychological Well-Being: The Polyphenol Intervention Trial (PPhIT).,"Mental ill health is currently one of the leading causes of disease burden worldwide. A growing body of data has emerged supporting the role of diet, especially polyphenols, which have anxiolytic and antidepressant-like properties. The aim of the present study was to assess the effect of a high polyphenol diet (HPD) compared to a low polyphenol diet (LPD) on aspects of psychological well-being in the Polyphenol Intervention Trial (PPhIT). Ninety-nine mildly hypertensive participants aged 40-65 years were enrolled in a four-week LPD washout period and then randomised to either an LPD or an HPD for eight weeks. Both at baseline and the end of intervention, participants' lifestyle and psychological well-being were assessed. The participants in the HPD group reported a decrease in depressive symptoms, as assessed by the Beck Depression Inventory-II, and an improvement in physical component and mental health component scores as assessed with 36-Item Short Form Survey. No differences in anxiety, stress, self-esteem or body image perception were observed. In summary, the study findings suggest that the adoption of a polyphenol-rich diet could potentially lead to beneficial effects including a reduction in depressive symptoms and improvements in general mental health status and physical health in hypertensive participants.",2020,"The participants in the HPD group reported a decrease in depressive symptoms, as assessed by the Beck Depression Inventory-II, and an improvement in physical component and mental health component scores as assessed with 36-Item Short Form Survey.","['Ninety-nine mildly hypertensive participants aged 40-65 years', 'hypertensive participants']","['low polyphenol diet (LPD', 'high polyphenol diet (HPD', 'polyphenol-rich diet', 'Polyphenol Diet', 'LPD or an HPD']","['physical component and mental health component scores', 'general mental health status and physical health', 'anxiety, stress, self-esteem or body image perception', 'depressive symptoms']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",99.0,0.0281013,"The participants in the HPD group reported a decrease in depressive symptoms, as assessed by the Beck Depression Inventory-II, and an improvement in physical component and mental health component scores as assessed with 36-Item Short Form Survey.","[{'ForeName': 'Meropi D', 'Initials': 'MD', 'LastName': 'Kontogianni', 'Affiliation': 'Department of Nutrition and Dietetics, Harokopio University, Eleftheriou Venizelou 70, 17671 Kallithea, Greece.'}, {'ForeName': 'Aswathy', 'Initials': 'A', 'LastName': 'Vijayakumar', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK.""}, {'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'Rooney', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK.""}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Noad', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK.""}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Appleton', 'Affiliation': 'Department of Psychology, Bournemouth University, Bournemouth BH12 5BB, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'McCarthy', 'Affiliation': ""Institute for Global Food Security, Queen's University Belfast, Belfast BT9 5DL, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Donnelly', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK.""}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Young', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK.""}, {'ForeName': 'Michelle C', 'Initials': 'MC', 'LastName': 'McKinley', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK.""}, {'ForeName': 'Pascal P', 'Initials': 'PP', 'LastName': 'McKeown', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK.""}, {'ForeName': 'Jayne V', 'Initials': 'JV', 'LastName': 'Woodside', 'Affiliation': ""Centre for Public Health, Queen's University Belfast, Belfast BT12 6BA, UK.""}]",Nutrients,['10.3390/nu12082445']
2886,32823974,"The Effect of a Multivitamin and Mineral Supplement on Immune Function in Healthy Older Adults: A Double-Blind, Randomized, Controlled Trial.","Older adults are at increased risk for vitamin and mineral deficiencies that contribute to age-related immune system decline. Several lines of evidence suggest that taking a multi-vitamin and mineral supplement (MVM) could improve immune function in individuals 55 and older. To test this hypothesis, we provided healthy older adults with either an MVM supplement formulated to improve immune function (Redoxon ®  VI, Singapore) or an identical, inactive placebo control to take daily for 12 weeks. Prior to and after treatment, we measured (1) their blood mineral and vitamin status (i.e., vitamin C, zinc and vitamin D); (2) immune function (i.e., whole blood bacterial killing activity, neutrophil phagocytic activity, and reactive oxygen species production); (3) immune status (salivary IgA and plasma cytokine/chemokine levels); and (4) self-reported health status. MVM supplementation improved vitamin C and zinc status in blood and self-reported health-status without altering measures of immune function or status or vitamin D levels, suggesting that healthy older adults may benefit from MVM supplementation. Further development of functional assays and larger study populations should improve detection of specific changes in immune function after supplementation in healthy older adults. Clinical Trials Registration: ClinicalTrials.gov #NCT02876315.",2020,"MVM supplementation improved vitamin C and zinc status in blood and self-reported health-status without altering measures of immune function or status or vitamin D levels, suggesting that healthy older adults may benefit from MVM supplementation.","['individuals 55 and older', 'Healthy Older Adults', 'healthy older adults with either an', 'healthy older adults', 'Older adults']","['Multivitamin and Mineral Supplement', 'MVM supplementation', 'multi-vitamin and mineral supplement (MVM', 'MVM supplement formulated to improve immune function (Redoxon ®  VI, Singapore) or an identical, inactive placebo control']","['blood mineral and vitamin status (i.e., vitamin C, zinc and vitamin D); (2) immune function (i.e., whole blood bacterial killing activity, neutrophil phagocytic activity, and reactive oxygen species production); (3) immune status (salivary IgA and plasma cytokine/chemokine levels); and (4) self-reported health status', 'immune function', 'vitamin C and zinc status', 'Immune Function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0556112', 'cui_str': 'Mineral supplement'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C1817756', 'cui_str': 'Immunologic function'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0162388', 'cui_str': 'Killing'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0020964', 'cui_str': 'Immune status'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018759', 'cui_str': 'Health status'}]",,0.187722,"MVM supplementation improved vitamin C and zinc status in blood and self-reported health-status without altering measures of immune function or status or vitamin D levels, suggesting that healthy older adults may benefit from MVM supplementation.","[{'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Fantacone', 'Affiliation': 'Linus Pauling Institute, Department of Biochemistry & Biophysics, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Malcolm B', 'Initials': 'MB', 'LastName': 'Lowry', 'Affiliation': 'Linus Pauling Institute, Department of Microbiology, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Sandra L', 'Initials': 'SL', 'LastName': 'Uesugi', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Michels', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Jaewoo', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Scott W', 'Initials': 'SW', 'LastName': 'Leonard', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Sean K', 'Initials': 'SK', 'LastName': 'Gombart', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Gombart', 'Affiliation': 'Linus Pauling Institute, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Bobe', 'Affiliation': 'Linus Pauling Institute, Department of Animal & Rangeland Sciences, Oregon State University, Corvallis, OR 97331, USA.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Gombart', 'Affiliation': 'Linus Pauling Institute, Department of Biochemistry & Biophysics, Oregon State University, Corvallis, OR 97331, USA.'}]",Nutrients,['10.3390/nu12082447']
2887,32824040,Interactive Low Back Pain Intervention Module Based on the Back School Program: A Cluster-Randomized Experimental Study Evaluating Its Effectiveness among Nurses in Public Hospitals.,"The prevalence of low back pain (LBP) among nurses is high. The main aim of this study was to evaluate the effectiveness of an interactive LBP module based on the Back School Program in improving Oswestry Disability Scores (ODSs) among nurses in government hospitals in Penang, Malaysia. A cluster-randomized experimental study was conducted within four public hospitals. These hospitals were randomized to intervention and control groups. A total of 284 nurses from the selected hospitals were randomly selected (142 in each group). An interactive LBP intervention module based on the Back School Program was designed and prescribed. Both the intervention and control groups were assessed using the Oswestry Disability Questionnaire at baseline and at the end of the third and sixth weeks. Out of 284 participants, 281 completed this study. A between-group comparison revealed that ODSs were significantly lower in the intervention group than in the control group at the ends of the third ( p  = 0.006) and sixth weeks ( p  < 0.001). Within-group changes revealed a significant reduction in ODSs within the intervention group from baseline to the third ( p  < 0.001) and sixth weeks ( p  < 0.001) of the intervention. This simple interactive LBP module was effective in reducing symptoms of LBP among nurses as early as three weeks, and this effect was sustained until the sixth week of the intervention.",2020,"This simple interactive LBP module was effective in reducing symptoms of LBP among nurses as early as three weeks, and this effect was sustained until the sixth week of the intervention.","['Back School Program', 'nurses in government hospitals in Penang, Malaysia', 'four public hospitals', '284 nurses from the selected hospitals were randomly selected (142 in each group', '284 participants, 281 completed this study', 'Nurses in Public Hospitals']","['Interactive Low Back Pain Intervention Module', 'interactive LBP module based on the Back School Program']","['Oswestry Disability Scores (ODSs', 'Oswestry Disability Questionnaire', 'ODSs', 'low back pain (LBP']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0337960', 'cui_str': 'Government hospital'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]",284.0,0.0391314,"This simple interactive LBP module was effective in reducing symptoms of LBP among nurses as early as three weeks, and this effect was sustained until the sixth week of the intervention.","[{'ForeName': 'Mohd Ismail', 'Initials': 'MI', 'LastName': 'Ibrahim', 'Affiliation': 'Department of Community Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan 16150, Malaysia.'}, {'ForeName': 'Izani Uzair', 'Initials': 'IU', 'LastName': 'Zubair', 'Affiliation': 'Penang Health State Department, 33 Pengkalan Weld, George Town, Penang 10300, Malaysia.'}, {'ForeName': 'Mohd Nazri', 'Initials': 'MN', 'LastName': 'Shafei', 'Affiliation': 'Department of Community Medicine, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan 16150, Malaysia.'}, {'ForeName': 'Mohd Izmi', 'Initials': 'MI', 'LastName': 'Ahmad', 'Affiliation': 'Hospital Pulau Pinang, Jalan Residensi, George Town, Penang 10990, Malaysia.'}, {'ForeName': 'Najib Majdi', 'Initials': 'NM', 'LastName': 'Yaacob', 'Affiliation': 'Units of Biostatistics and Research Methodology, School of Medical Sciences, Health Campus, Universiti Sains Malaysia, Kubang Kerian, Kelantan 16150, Malaysia.'}]",International journal of environmental research and public health,['10.3390/ijerph17165916']
2888,32824061,Promoting a Healthy Lifestyle through Mindfulness in University Students: A Randomized Controlled Trial.,"The present study explored the effects of a second-generation mindfulness-based intervention known as  flow meditation  ( Meditación-Fluir ) in the improvement of healthy life behaviors. A sample of university students ( n  = 51) in Spain were randomly assigned to a seven-week mindfulness treatment or a waiting list control group. Results showed that compared to the control group, individuals in the mindfulness group demonstrated significant improvements across all outcome measures including healthy eating habits (balanced diet, intake rate, snacking between meals, decrease in consumption by negative emotional states, increased consumption by negative emotional states, amount of consumption, meal times, consumption of low-fat products), tobacco, alcohol, and cannabis consumption, and resting habits. There were differences between males and females in some of these variables and a better effect of the treatment was evident in the females of the experimental group when compared to the males. The  flow meditation  program shows promise for fostering a healthy lifestyle, thus decreasing behaviors related to maladaptive eating, tobacco, alcohol, and cannabis consumption as well as negative rest habits in university students. This mindfulness program could significantly contribute to the treatment of eating disorders and addictions, wherein negative emotional states and impulsivity are central features of the condition.",2020,"Results showed that compared to the control group, individuals in the mindfulness group demonstrated significant improvements across all outcome measures including healthy eating habits (balanced diet, intake rate, snacking between meals, decrease in consumption by negative emotional states, increased consumption by negative emotional states, amount of consumption, meal times, consumption of low-fat products), tobacco, alcohol, and cannabis consumption, and resting habits.","['healthy life behaviors', 'A sample of university students ( n  = 51) in Spain', 'university students', 'Healthy Lifestyle through Mindfulness in University Students']","['second-generation mindfulness-based intervention known as  flow meditation  ( Meditación-Fluir ', 'seven-week mindfulness treatment or a waiting list control group']","['healthy eating habits (balanced diet, intake rate, snacking between meals, decrease in consumption by negative emotional states, increased consumption by negative emotional states, amount of consumption, meal times, consumption of low-fat products), tobacco, alcohol, and cannabis consumption, and resting habits']","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0452410', 'cui_str': 'Balanced diet'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0587121', 'cui_str': 'Between meals'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]",,0.0158131,"Results showed that compared to the control group, individuals in the mindfulness group demonstrated significant improvements across all outcome measures including healthy eating habits (balanced diet, intake rate, snacking between meals, decrease in consumption by negative emotional states, increased consumption by negative emotional states, amount of consumption, meal times, consumption of low-fat products), tobacco, alcohol, and cannabis consumption, and resting habits.","[{'ForeName': 'Encarnación', 'Initials': 'E', 'LastName': 'Soriano-Ayala', 'Affiliation': 'Department of Education, Universidad de Almería, 04120 Almeria, Spain.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Amutio', 'Affiliation': 'Department of Work Relations and Social Work, University of the Basque Country (UPV/EHU), 48940 Bilbao, Spain.'}, {'ForeName': 'Clemente', 'Initials': 'C', 'LastName': 'Franco', 'Affiliation': 'Department of Psychology, Universidad de Almería, 04120 Almeria, Spain.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Mañas', 'Affiliation': 'Department of Psychology, Universitat Oberta de Catalunya, 08018 Barcelona, Spain.'}]",Nutrients,['10.3390/nu12082450']
2889,32824168,Visual Attentional Training Improves Reading Capabilities in Children with Dyslexia: An Eye Tracker Study During a Reading Task.,"Dyslexia is a specific disorder in reading abilities. The aim of this study was to explore whether a short visual attentional training could improve reading capabilities in children with reading disorders by changing their oculomotor characteristics. Two groups (G1 and G2) of 25 children with reading disabilities and who are matched in IQ (intelligence quotient), sex, and age participated in the study. The allocation of a subject to a specific group (G1 = experimental group; G2 = control group) was generated in an unpredictable random sequence. The reading task was recorded twice for G1, i.e., before (T1) and after (T2) 10 min of visual attentional training. Training consisted of oculomotor tasks (saccades and pursuits movements) and searching tasks (three different exercises). For G2, the two reading tasks at T1 and T2 were done at an interval of 10 min instead. We found that at T1, oculomotor performances during reading were statistically similar for both groups of children with reading disabilities (G1 and G2). At T2, the group G1 only improved oculomotor capabilities significantly during reading; in particular, children read faster, and their fixation time was shortest. We conclude that short visual attentional training could improve the cortical mechanisms responsible for attention and reading capabilities. Further studies on a larger number of dyslexic children will be necessary in order to explore the effects of different training types on the visual attentional span given its important role on the orienting and focusing visuospatial attention and on the oculomotor performance in children with dyslexia.",2020,"We found that at T1, oculomotor performances during reading were statistically similar for both groups of children with reading disabilities (G1 and G2).","['Children with Dyslexia', 'children with dyslexia', '25 children with reading disabilities and who are matched in IQ (intelligence quotient), sex, and age participated in the study', 'children with reading disorders by changing their oculomotor characteristics']","['visual attentional training', 'short visual attentional training', 'oculomotor tasks (saccades and pursuits movements) and searching tasks (three different exercises', 'Visual Attentional Training']","['fixation time', 'reading capabilities', 'oculomotor capabilities']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0476254', 'cui_str': 'Dyslexia'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0456149', 'cui_str': 'Intelligence quotient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0036019', 'cui_str': 'Saccadic eye movement'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]",25.0,0.0216168,"We found that at T1, oculomotor performances during reading were statistically similar for both groups of children with reading disabilities (G1 and G2).","[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Caldani', 'Affiliation': 'UMR 7114 MoDyCo, CNRS-Université Paris Nanterre, 92000 Nanterre, France.'}, {'ForeName': 'Christophe-Loïc', 'Initials': 'CL', 'LastName': 'Gerard', 'Affiliation': 'Child and Adolescent Psychiatry Department, Robert Debré Hospital, 75019 Paris, France.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Peyre', 'Affiliation': 'Child and Adolescent Psychiatry Department, Robert Debré Hospital, 75019 Paris, France.'}, {'ForeName': 'Maria Pia', 'Initials': 'MP', 'LastName': 'Bucci', 'Affiliation': 'UMR 7114 MoDyCo, CNRS-Université Paris Nanterre, 92000 Nanterre, France.'}]",Brain sciences,['10.3390/brainsci10080558']
2890,32824185,Dorsolateral Prefrontal Cortex Activity during a Brain Training Game Predicts Cognitive Improvements after Four Weeks' Brain Training Game Intervention: Evidence from a Randomized Controlled Trial.,"BACKGROUND


Recent studies have demonstrated that brain activities using NIRS (near-infrared spectroscopy) at baseline during cognitive tasks (e.g., N-back task) can predict the cognitive benefits of a cognitive training. In this study, we investigated whether brain activities during brain training game (BT) at baseline would predict benefits to cognitive functions after the intervention period.
METHODS


In a four-week double-blinded randomized control trial (RCT) 72 young adults were randomly assigned to one of the two groups: participants in the BT group played specific game, called the Brain Age. Participants in an active control group (ACT) played the puzzle game Tetris. We measured brain activity during the training games using two channel NIRS before the intervention period. Cognitive functions were tested before and after the four-week intervention period.
RESULTS


The BT showed significant improvements in inhibition, processing speed, and working memory performance compared to ACT. The left and right DLPFC (dorsolateral prefrontal cortex) brain activities during the BT at baseline were associated with improvements in inhibition and processing speed.
DISCUSSION


This randomized control trial first provides scientific evidence that DLPFC activities during BT at baseline can predict cognitive improvements after a four-week intervention period.",2020,"The left and right DLPFC (dorsolateral prefrontal cortex) brain activities during the BT at baseline were associated with improvements in inhibition and processing speed.
",['72 young adults'],"['active control group (ACT) played the puzzle game', 'brain training game (BT', 'BT group played specific game, called the Brain Age']","['Cognitive functions', 'brain activity', 'inhibition, processing speed, and working memory performance', 'left and right DLPFC (dorsolateral prefrontal cortex) brain activities']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0423995', 'cui_str': 'Puzzled'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]",72.0,0.157709,"The left and right DLPFC (dorsolateral prefrontal cortex) brain activities during the BT at baseline were associated with improvements in inhibition and processing speed.
","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Nouchi', 'Affiliation': 'Department of Cognitive Health Science, Institute of Development, Aging and Cancer (IDAC), Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Natasha Yuriko Dos Santos', 'Initials': 'NYDS', 'LastName': 'Kawata', 'Affiliation': 'Department of Functional Brain Imaging, Institute of Development, Aging and Cancer (IDAC), Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Department of Functional Brain Imaging, Institute of Development, Aging and Cancer (IDAC), Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Robin Maximilian', 'Initials': 'RM', 'LastName': 'Himmelmeier', 'Affiliation': 'Department of Functional Brain Imaging, Institute of Development, Aging and Cancer (IDAC), Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Nakamura', 'Affiliation': 'Department of Functional Brain Imaging, Institute of Development, Aging and Cancer (IDAC), Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Nouchi', 'Affiliation': 'Department of Cognitive Health Science, Institute of Development, Aging and Cancer (IDAC), Tohoku University, Sendai 980-8575, Japan.'}, {'ForeName': 'Ryuta', 'Initials': 'R', 'LastName': 'Kawashima', 'Affiliation': 'Smart Aging Research Center (S.A.R.C.), Tohoku University, Seiryo-machi 4-1, Sendai 980-8575, Japan.'}]",Brain sciences,['10.3390/brainsci10080560']
2891,32824190,The Smartphone-Assisted Intervention Improved Perception of Nutritional Status among Middle School Students.,"Misperception of nutritional status is common and hinders the progress of childhood obesity prevention. This study aimed to examine the effectiveness of a smartphone-assisted intervention to improve student and parental perception of students' nutritional status (underweight, normal weight, overweight, obese). We conducted a parallel-group controlled trial with a non-randomized design in three junior middle schools of Beijing, China in 2019. One school was allocated to the intervention group and two schools to the control group. A total of 573 students (aged 13.1 ± 0.4 years) participated in the trial. The 3-month intervention included three components: health education sessions for students and parents, regular monitoring of students' weight, and the provision of feedback via a smartphone application. Schools in the control group continued their usual practice. Primary outcomes included the student and parental accurate perception of students' nutritional status. The percentage of students' accurate perception of their own nutritional status in the intervention group increased from 49.0% to 59.2% from baseline to three months, whereas it decreased from 64.1% to 58.1% in the control group; the adjusted odds ratio (OR) between the two groups was 1.71 (95% confidence interval (CI): 1.13, 2.59). The intervention did not significantly improve parental perception of students' nutritional status ( p  > 0.05). The study findings provided a brief approach for improving perception of nutritional status among middle school students.",2020,The intervention did not significantly improve parental perception of students' nutritional status ( p  > 0.05).,"['Middle School Students', 'middle school students', 'three junior middle schools of Beijing, China in 2019', 'A total of 573 students (aged 13.1 ± 0.4 years) participated in the trial', ""students' nutritional status (underweight, normal weight, overweight, obese""]","['Smartphone-Assisted Intervention', 'smartphone-assisted intervention', ""health education sessions for students and parents, regular monitoring of students' weight, and the provision of feedback via a smartphone application""]","[""student and parental accurate perception of students' nutritional status"", ""parental perception of students' nutritional status"", ""percentage of students' accurate perception of their own nutritional status""]","[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4708164', 'cui_str': '573'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0392209', 'cui_str': 'Nutritional status'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",3.0,0.0150395,The intervention did not significantly improve parental perception of students' nutritional status ( p  > 0.05).,"[{'ForeName': 'Yan-Hui', 'Initials': 'YH', 'LastName': 'Shen', 'Affiliation': 'Department of School Health, Beijing Haidian District Center for Diseases Prevention and Control, Beijing 100095, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Wen-Hao', 'Initials': 'WH', 'LastName': 'Li', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Jin-Hui', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}, {'ForeName': 'Chu', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of School Health, Beijing Haidian District Center for Diseases Prevention and Control, Beijing 100095, China.'}, {'ForeName': 'Hai-Jun', 'Initials': 'HJ', 'LastName': 'Wang', 'Affiliation': 'Department of Maternal and Child Health, School of Public Health, Peking University, Beijing 100191, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17165932']
2892,32824214,Estimated Intakes of Nutrients and Polyphenols in Participants Completing the MaPLE Randomised Controlled Trial and Its Relevance for the Future Development of Dietary Guidelines for the Older Subjects.,"The evaluation of food intake in older subjects is crucial in order to be able to verify adherence to nutritional recommendations. In this context, estimation of the intake of specific dietary bioactives, such as polyphenols, although particularly challenging, is necessary to plan possible intervention strategies to increase their intake. The aims of the present study were to: (i) evaluate the nutritional composition of dietary menus provided in a residential care setting; (ii) estimate the actual intake of nutrients and polyphenols in a group of older subjects participating in the MaPLE study; and (iii) investigate the impact of an eight-week polyphenol-rich dietary pattern, compared to an eight-week control diet, on overall nutrient and polyphenol intake in older participants. The menus served to the participants provided ~770 mg per day of total polyphenols on average with small variations between seasons. The analysis of real consumption, measured using weighed food diaries, demonstrated a lower nutrient (~20%) and polyphenol intake (~15%) compared to that provided by the menus. The feasibility of dietary patterns that enable an increase in polyphenol intake with putative health benefits for age-related conditions is discussed, with a perspective to developing dietary guidelines for this target population.",2020,The menus served to the participants provided ~770 mg per day of total polyphenols on average with small variations between seasons.,"['older subjects', 'older participants', 'Participants', 'older subjects participating in the MaPLE study; and (iii', 'Older Subjects']","['polyphenol-rich dietary pattern, compared to an eight-week control diet, on overall nutrient and polyphenol intake', 'nutrients and polyphenols']","['polyphenol intake', 'Estimated Intakes of Nutrients and Polyphenols']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0330996', 'cui_str': 'Genus Acer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}]",,0.0158559,The menus served to the participants provided ~770 mg per day of total polyphenols on average with small variations between seasons.,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Martini', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Bernardi', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': ""Del Bo'"", 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hidalgo Liberona', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Zamora-Ros', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Tucci', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cherubini', 'Affiliation': ""Geriatria, Accettazione Geriatrica e Centro di ricerca per l'invecchiamento, IRCCS INRCA, 60127 Ancona, Italy.""}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Porrini', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Gargari', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'González-Domínguez', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Gregorio', 'Initials': 'G', 'LastName': 'Peron', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Kirkup', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, Norwich NR4 7UG, UK.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Kroon', 'Affiliation': 'Quadram Institute Bioscience, Norwich Research Park, Norwich NR4 7UG, UK.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Andres-Lacueva', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, 08028 Barcelona, Spain.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Guglielmetti', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Riso', 'Affiliation': 'Department of Food, Environmental and Nutritional Sciences (DeFENS), Università degli Studi di Milano, 20133 Milan, Italy.'}]",Nutrients,['10.3390/nu12082458']
2893,32824387,A Traditional Korean Diet with a Low Dietary Inflammatory Index Increases Anti-Inflammatory IL-10 and Decreases Pro-Inflammatory NF-κB in a Small Dietary Intervention Study.,"Chronic low-grade inflammation may increase the risk of chronic disease, while diets rich in anti-inflammatory components may reduce it. To determine the anti-inflammatory properties of the traditional Korean diet (K-diet) that comprises high amounts of vegetables, fiber and phytochemicals, moderate amounts of legumes, and low amounts of animal fat, ten obese women aged 50-60 years were randomly assigned to the K-diet or control diet group. The control diet was a Westernized Korean diet commonly consumed in Korea, which is high in animal fat and protein. Subjects were housed in metabolic unit-like conditions during the 2-week intervention. Plasma was collected before and after the intervention to measure inflammatory cytokines using ELISA. The dietary inflammatory index (DII) was calculated based on nutrients and food intake. The DII score for the K-diet was lower than that of the control diet (-0.94 ± 1.39 vs. 1.04 ± 1.61,  p  < 0.001). In the K-diet group, anti-inflammatory interleukin (IL)-10 levels increased (4.45 ± 0.34 pg/mL vs. 5.94 ± 0.33 pg/mL,  p  = 0.0102), whereas pro-inflammatory nuclear factor kappa B (NF-κB) levels decreased (7.70 ± 0.62 pg/mL vs. 2.71 ± 0.49 pg/mL,  p  = 0.0015), but not in the control group. In the K-diet group, NF-κB levels negatively correlated with IL-10 levels (r = -0.794,  p  = 0.006). The K-diet has anti-inflammatory properties, and IL-10 and NF-κB are putative inflammatory markers for K-diet studies.",2020,"In the K-diet group, anti-inflammatory interleukin (IL)-10 levels increased (4.45 ± 0.34 pg/mL vs. 5.94 ± 0.33 pg/mL,  p  = 0.0102), whereas pro-inflammatory nuclear factor kappa B (NF-κB) levels decreased (7.70 ± 0.62 pg/mL vs. 2.71 ± 0.49 pg/mL,  p  = 0.0015), but not in the control group.",['ten obese women aged 50-60 years'],"['K-diet or control diet group', 'traditional Korean diet (K-diet']","['DII score for the K-diet', 'IL-10 levels', 'NF-κB levels', 'Plasma', 'anti-inflammatory interleukin (IL)-10 levels', 'dietary inflammatory index (DII', 'pro-inflammatory nuclear factor kappa B (NF-κB) levels']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079904', 'cui_str': 'Immunoglobulin Enhancer-Binding Protein'}]",10.0,0.0199436,"In the K-diet group, anti-inflammatory interleukin (IL)-10 levels increased (4.45 ± 0.34 pg/mL vs. 5.94 ± 0.33 pg/mL,  p  = 0.0102), whereas pro-inflammatory nuclear factor kappa B (NF-κB) levels decreased (7.70 ± 0.62 pg/mL vs. 2.71 ± 0.49 pg/mL,  p  = 0.0015), but not in the control group.","[{'ForeName': 'Phil-Kyung', 'Initials': 'PK', 'LastName': 'Shin', 'Affiliation': 'CHA Bio Complex, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Seon-Joo', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Seongnam 13120, Korea.'}, {'ForeName': 'Myung Sunny', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Dae Young', 'Initials': 'DY', 'LastName': 'Kwon', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'Min Jung', 'Initials': 'MJ', 'LastName': 'Kim', 'Affiliation': 'Research Group of Healthcare, Korea Food Research Institute, Wanju 55365, Korea.'}, {'ForeName': 'KyongChol', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'GangNam Major Hospital, Seoul 06279, Korea.'}, {'ForeName': 'Sukyung', 'Initials': 'S', 'LastName': 'Chun', 'Affiliation': 'CHA Bio Complex, CHA University, Seongnam 13488, Korea.'}, {'ForeName': 'Hae-Jeung', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Food and Nutrition, College of BioNano Technology, Gachon University, Seongnam 13120, Korea.'}, {'ForeName': 'Sang-Woon', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'CHA Bio Complex, CHA University, Seongnam 13488, Korea.'}]",Nutrients,['10.3390/nu12082468']
2894,32824392,"The Role of Primary Tumor Resection in Colorectal Cancer Patients with Asymptomatic, Synchronous, Unresectable Metastasis: A Multicenter Randomized Controlled Trial.","We aimed to assess the survival benefits of primary tumor resection (PTR) followed by chemotherapy in patients with asymptomatic stage IV colorectal cancer with asymptomatic, synchronous, unresectable metastases compared to those of upfront chemotherapy alone. This was an open-label, prospective, randomized controlled trial (ClnicalTrials.gov Identifier: NCT01978249). From May 2013 to April 2016, 48 patients (PTR,  n  = 26; upfront chemotherapy,  n  = 22) diagnosed with asymptomatic colorectal cancer with unresectable metastases in 12 tertiary hospitals were randomized (1:1). The primary endpoint was two-year overall survival. The secondary endpoints were primary tumor-related complications, PTR-related complications, and rate of conversion to resectable status. The two-year cancer-specific survival was significantly higher in the PTR group than in the upfront chemotherapy group (72.3% vs. 47.1%;  p  = 0.049). However, the two-year overall survival rate was not significantly different between the PTR and upfront chemotherapy groups (69.5% vs. 44.8%,  p  = 0.058). The primary tumor-related complication rate was 22.7%. The PTR-related complication rate was 19.2%, with a major complication rate of 3.8%. The rates of conversion to resectable status were 15.3% and 18.2% in the PTR and upfront chemotherapy groups. While PTR followed by chemotherapy resulted in better two-year cancer-specific survival than upfront chemotherapy, the improvement in the two-year overall survival was not significant.",2020,The two-year cancer-specific survival was significantly higher in the PTR group than in the upfront chemotherapy group (72.3% vs. 47.1%;  p  = 0.049).,"['Colorectal Cancer Patients with Asymptomatic, Synchronous, Unresectable Metastasis', '48 patients (PTR,  n  = 26; upfront chemotherapy,  n  = 22) diagnosed with asymptomatic colorectal cancer with unresectable metastases in 12 tertiary hospitals', 'patients with asymptomatic stage IV colorectal cancer with asymptomatic, synchronous, unresectable metastases']","['PTR', 'primary tumor resection (PTR) followed by chemotherapy']","['cancer-specific survival', 'primary tumor-related complications, PTR-related complications, and rate of conversion to resectable status', 'year cancer-specific survival', 'overall survival rate', 'overall survival', 'survival benefits', 'year overall survival', 'complication rate', 'PTR-related complication rate', 'rates of conversion to resectable status']","[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0677950', 'cui_str': 'Colorectal cancer stage IV'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.232137,The two-year cancer-specific survival was significantly higher in the PTR group than in the upfront chemotherapy group (72.3% vs. 47.1%;  p  = 0.049).,"[{'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Park', 'Affiliation': 'Division of Colon and Rectal Surgery, Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Korea.'}, {'ForeName': 'Jeong-Heum', 'Initials': 'JH', 'LastName': 'Baek', 'Affiliation': 'Department of Surgery, Gil Medical Center, Gachon University College of Medicine, Incheon 21565, Korea.'}, {'ForeName': 'Gyu-Seog', 'Initials': 'GS', 'LastName': 'Choi', 'Affiliation': 'Colorectal Cancer Center, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu 41404, Korea.'}, {'ForeName': 'Won Cheol', 'Initials': 'WC', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Wonkwang University School of Medicine, Iksan 54538, Korea.'}, {'ForeName': 'Chang Sik', 'Initials': 'CS', 'LastName': 'Yu', 'Affiliation': 'Department of Colon and Rectal Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul 05505, Korea.'}, {'ForeName': 'Sung-Bum', 'Initials': 'SB', 'LastName': 'Kang', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam 13620, Korea.'}, {'ForeName': 'Byung Soh', 'Initials': 'BS', 'LastName': 'Min', 'Affiliation': 'Division of Colon and Rectal Surgery, Department of Surgery, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Jae Hwang', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Yeungnam University College of Medicine, Daegu 42415, Korea.'}, {'ForeName': 'Hyeong Rok', 'Initials': 'HR', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital and Medical School, Hwasun 58128, Korea.'}, {'ForeName': 'Bong Hwa', 'Initials': 'BH', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Hallym University Sacred Heart Hospital, Anyang 14068, Korea.'}, {'ForeName': 'Jae Hwan', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Center for Colorectal Cancer, Research Institute and Hospital, National Cancer Center, Goyang 10408, Korea.'}, {'ForeName': 'Seung-Yong', 'Initials': 'SY', 'LastName': 'Jeong', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Colorectal Cancer Center, Seoul National University Cancer Hospital, Seoul 03080, Korea.'}, {'ForeName': 'Minkyu', 'Initials': 'M', 'LastName': 'Jung', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Joong Bae', 'Initials': 'JB', 'LastName': 'Ahn', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul 03722, Korea.'}, {'ForeName': 'Seung Hyuk', 'Initials': 'SH', 'LastName': 'Baik', 'Affiliation': 'Division of Colon and Rectal Surgery, Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul 06273, Korea.'}]",Cancers,['10.3390/cancers12082306']
2895,32824394,"Effects of Virtual Reality versus Exercise on Pain, Functional, Somatosensory and Psychosocial Outcomes in Patients with Non-specific Chronic Neck Pain: A Randomized Clinical Trial.","Background : Virtual reality (VR) applied to patients with neck pain is a promising intervention to produce positive effects when used alone or combined with exercise. Therefore, the objective of this manuscript is to compare the effects of VR versus exercise treatment on pain intensity, conditioned pain modulation (CPM), temporal summation (TS) and functional and somatosensory outcomes in patients with non-specific chronic neck pain (NS-CNP).  Methods : A single-blinded, randomized clinical trial was carried out. A total sample of 44 patients with NS-CNP was randomized into a VR treatment group or neck exercises group. The intervention consisted of two treatment sessions per week, for four weeks and eight sessions. Four measurement moments (at baseline, immediately, 1 month, and 3 months after intervention) were considered. Pain intensity, CPM, TS, functional and somatosensory outcomes were measured.  Results : Statistically significant differences were revealed for time factor (F = 16.40,  p  < 0.01, η p 2  = 0.28) and group*time interaction for kinesiophobia (F = 3.89,  p  = 0.01, η p 2  = 0.08) showing post-hoc differences in favor of the VR group at 3 months ( p  < 0.05, d = 0.65). Significant effects were shown for time factor ( p  < 0.05) but not for the group*time interaction ( p  > 0.05) for pain intensity, rotation range of motion (ROM), Neck Disability Index, pain catastrophizing, fear-avoidance beliefs, left side pressure pain threshold (PPT) and anxiety. Statistically significant differences were not found for time factor ( p  > 0.05) and neither in group*time interaction ( p  > 0.05) for CPM, TS, right side PPT, flexo-extension and lateral-flexion ROM.  Conclusions : Kinesiophobia was the only outcome that showed differences between VR and exercise at 3 months. Nevertheless, pain intensity, CPM, TS, ROM, neck disability, pain catastrophizing, fear-avoidance beliefs, PPT and anxiety did not show differences between both interventions.",2020,"Statistically significant differences were not found for time factor ( p  > 0.05) and neither in group*time interaction ( p  > 0.05) for CPM, TS, right side PPT, flexo-extension and lateral-flexion ROM.  ","['Patients with Non-specific Chronic Neck Pain', 'patients with non-specific chronic neck pain (NS-CNP', '44 patients with NS-CNP', 'patients with neck pain']","[' ', 'Kinesiophobia', 'Virtual Reality versus Exercise', 'Virtual reality (VR', 'VR treatment group or neck exercises group', 'VR versus exercise']","['CPM, TS, right side PPT, flexo-extension and lateral-flexion ROM', 'pain intensity, CPM, TS, ROM, neck disability, pain catastrophizing, fear-avoidance beliefs, PPT and anxiety', 'pain intensity, rotation range of motion (ROM), Neck Disability Index, pain catastrophizing, fear-avoidance beliefs, left side pressure pain threshold (PPT) and anxiety', 'time factor', 'group*time interaction for kinesiophobia', 'pain intensity, conditioned pain modulation (CPM), temporal summation (TS) and functional and somatosensory outcomes', 'Pain intensity, CPM, TS, functional and somatosensory outcomes', 'Pain, Functional, Somatosensory and Psychosocial Outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}]","[{'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0454347', 'cui_str': 'Neck exercises'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0234110', 'cui_str': 'Temporal summation'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0032334', 'cui_str': 'podofilox'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0040225', 'cui_str': 'Time Factors'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",44.0,0.113865,"Statistically significant differences were not found for time factor ( p  > 0.05) and neither in group*time interaction ( p  > 0.05) for CPM, TS, right side PPT, flexo-extension and lateral-flexion ROM.  ","[{'ForeName': 'David Morales', 'Initials': 'DM', 'LastName': 'Tejera', 'Affiliation': 'Escuela Internacional de Doctorado, Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, 28032 Alcorcón, Spain.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'Beltran-Alacreu', 'Affiliation': 'Departamento de Fisioterapia, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, 28043 Madrid, Spain.'}, {'ForeName': 'Roberto Cano-de-la-Cuerda Jose Vicente Leon', 'Initials': 'RCJVL', 'LastName': 'Hernández', 'Affiliation': 'Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine. Rey Juan Carlos University, 28922 Madrid, Spain.'}, {'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Martín-Pintado-Zugasti', 'Affiliation': 'Departamento de Fisioterapia, Facultad de Medicina, Universidad San Pablo-CEU, CEU Universities, Madrid 28008, Spain.'}, {'ForeName': 'César Calvo-Lobo Alfonso', 'Initials': 'CCA', 'LastName': 'Gil-Martínez', 'Affiliation': 'Facultad de Enfermería, Fisioterapia y Podología, Universidad Complutense de Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'Josué', 'Initials': 'J', 'LastName': 'Fernández-Carnero', 'Affiliation': 'CranioSpain Research Group, Centro Superior de Estudios Universitarios La Salle, Universidad Autónoma de Madrid, 28043 Madrid, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17165950']
2896,32824408,Lower Postprandial Thermogenic Response to an Unprocessed Whole Food Meal Compared to an Iso-Energetic/Macronutrient Meal Replacement in Young Women: A Single-Blind Randomized Cross-Over Trial.,"In contrast to ultra-processed foods that are associated with increased weight gain and obesity risk, nutritionally engineered dietary supplements, including meal replacement (MR) bars and shakes, are generally promoted as healthy. Limited data is available comparing the metabolic and hunger responses of whole food (WF) versus MR meals. The purpose of this study was to directly compare the thermic effect (TEM), respiratory exchange ratio (RER), hunger/taste ratings, and glucose response of two different breakfast meals containing MR and WF products in young healthy women. Eight volunteers completed two iso-caloric (529 kcals)/macronutrient (50% carbohydrates; 26% fat; 24% protein) test meals in a single-blind, randomized crossover design: (1) whole food meal; or (2) meal replacement. TEM was significantly higher following MR compared with WF (percent mean difference: 7.76 ± 3.78%; absolute mean difference: 0.053 ± 0.026 kcal/minute,  p  = 0.048), whereas WF substrate utilization demonstrated lower carbohydrate oxidation (RER) than MR (mean difference: -0.024 ± 0.008,  p  = 0.005). No differences existed for blood glucose response and feelings of hunger, desire to eat, and satiety among trials. Consumption of an MR meal increases postprandial thermogenesis and RER compared to a WF meal, which may impact weight control and obesity risk over the long-term.",2020,"TEM was significantly higher following MR compared with WF (percent mean difference: 7.76 ± 3.78%; absolute mean difference: 0.053 ± 0.026 kcal/minute,  p  = 0.048), whereas WF substrate utilization demonstrated lower carbohydrate oxidation (RER) than MR (mean difference: -0.024 ± 0.008,  ","['young healthy women', 'Young Women']","['MR meal', 'Unprocessed Whole Food Meal', 'whole food meal; or (2) meal replacement', 'Macronutrient Meal Replacement']","['thermic effect (TEM), respiratory exchange ratio (RER), hunger/taste ratings, and glucose response', 'Lower Postprandial Thermogenic Response', 'postprandial thermogenesis and RER', 'weight gain and obesity risk', 'TEM', 'carbohydrate oxidation (RER', 'blood glucose response and feelings of hunger, desire to eat, and satiety']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0453870', 'cui_str': 'Whole food'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}]",8.0,0.0715045,"TEM was significantly higher following MR compared with WF (percent mean difference: 7.76 ± 3.78%; absolute mean difference: 0.053 ± 0.026 kcal/minute,  p  = 0.048), whereas WF substrate utilization demonstrated lower carbohydrate oxidation (RER) than MR (mean difference: -0.024 ± 0.008,  ","[{'ForeName': 'Alex E', 'Initials': 'AE', 'LastName': 'Mohr', 'Affiliation': 'College of Health Solutions, Arizona State University, Phoenix, AZ 85004, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Ramos', 'Affiliation': 'Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Tavarez', 'Affiliation': 'Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Arciero', 'Affiliation': 'Department of Health and Human Physiological Sciences, Skidmore College, Saratoga Springs, NY 12866, USA.'}]",Nutrients,['10.3390/nu12082469']
2897,32824416,"Physical Activity, Sedentary Behavior, and Sleep Quality in Adults with Primary Hypertension and Obesity before and after an Aerobic Exercise Program: EXERDIET-HTA Study.","BACKGROUND


The purposes of the study were to: analyze, by objective (accelerometry) and subjective (International Physical Activity Questionnaire, IPAQ) methodologies, the physical activity (PA) and sedentary behavior (SB) in healthy adults (HEALTHY,  n  = 30) and individuals with primary hypertension (HTN) and overweight/obesity ( n  = 218); assess the effects of an aerobic exercise intervention on physical activity (PA), sedentary behavior (SB), and sleep quality in the HTN group; and evaluate the relationship between objectively measured and subjectively reported PA and SB.
METHODS


The measurements were performed before a 16-week exercise intervention period in both HEALTHY and HTN groups and after the intervention period only in the HTN group, randomized to attention control or exercise training (ExT) subgroups.
RESULTS


The HEALTHY group showed more moderate-to-vigorous PA ( p  < 0.05) and better sleep quality ( p  < 0.05) than the HTN group, but no difference in SB. After the intervention, HTN participants' PA and SB, objectively measured by accelerometry, were unchanged, but increased PA and decreased SB ( p  < 0.05) were observed through IPAQ in ExT. The intervention was effective in improving sleep quality in HTN participants.
CONCLUSIONS


The differences in moderate-to-vigorous PA and SB may be useful in defining the health profile of a population. The supervised aerobic exercise program was effective in increasing PA, reducing SB, and improving sleep quality in overweight/obese adults with HTN. Accelerometer-measured and self-reported data were not comparable, but complementary.",2020,"The HEALTHY group showed more moderate-to-vigorous PA ( p  < 0.05) and better sleep quality ( p  < 0.05) than the HTN group, but no difference in SB.","['overweight/obese adults with HTN', 'healthy adults (HEALTHY,  n  = 30) and individuals with primary hypertension (HTN) and overweight/obesity ( n  = 218', 'Adults with Primary Hypertension and Obesity before and after an Aerobic Exercise Program']","['aerobic exercise intervention', 'exercise intervention period in both HEALTHY and HTN', 'attention control or exercise training (ExT) subgroups', 'supervised aerobic exercise program']","['SB', 'moderate-to-vigorous PA', 'Physical Activity, Sedentary Behavior, and Sleep Quality', 'physical activity (PA), sedentary behavior (SB), and sleep quality', 'PA and decreased SB', 'objective (accelerometry) and subjective (International Physical Activity Questionnaire, IPAQ) methodologies, the physical activity (PA) and sedentary behavior (SB', 'sleep quality']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0969625', 'cui_str': 'methodology'}]",,0.0243219,"The HEALTHY group showed more moderate-to-vigorous PA ( p  < 0.05) and better sleep quality ( p  < 0.05) than the HTN group, but no difference in SB.","[{'ForeName': 'Aitor', 'Initials': 'A', 'LastName': 'Martinez Aguirre-Betolaza', 'Affiliation': 'Department of Physical Education and Sport. Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz. Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Mujika', 'Affiliation': 'GIzartea, Kirola eta Ariketa Fisikoa Ikerkuntza Taldea (GIKAFIT), Society, Sports, and Physical Exercise Research Group, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz. Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Loprinzi', 'Affiliation': 'Department of Health, Exercise Science, and Recreation Management, The University of Mississippi, Oxford, MS 38677, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Corres', 'Affiliation': 'Department of Physical Education and Sport. Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz. Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Ilargi', 'Initials': 'I', 'LastName': 'Gorostegi-Anduaga', 'Affiliation': 'Department of Physical Education and Sport. Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz. Araba/Álava, Basque Country, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Maldonado-Martín', 'Affiliation': 'Department of Physical Education and Sport. Faculty of Education and Sport-Physical Activity and Sport Sciences Section, University of the Basque Country (UPV/EHU), 01007 Vitoria-Gasteiz. Araba/Álava, Basque Country, Spain.'}]","Life (Basel, Switzerland)",['10.3390/life10080153']
2898,32824425,Changes in the Diversity of Human Skin Microbiota to Cosmetic Serum Containing Prebiotics: Results from a Randomized Controlled Trial.,"Prebiotic treatment may rebalance the skin microbiota by regulating the growth of harmful and beneficial microorganisms. In this randomized, double-blind, placebo-controlled clinical trial (N = 60), we evaluated the effects of a cosmetic serum containing galacto-oligosaccharides (GOS) on the balance of the skin microbiota by measuring various skin parameters. The skin water-holding capacity between the control (ND) and experimental (NF) groups was significantly different after 8 weeks of serum treatment ( p  < 0.05). Similarly, changes in transepidermal water loss (TEWL) and the erythema index in the ND and NF groups were significantly different ( p  < 0.05). Furthermore, the wrinkle depth and  Staphylococcus aureus  population decreased in the NF group compared with those in the ND group ( p  < 0.05). The mean form factor, Shannon index, and  Pediococcus  population were significantly increased in the post-NF group compared with those in the post-ND group ( p  < 0.05). Finally, in the ND group, water-holding capacity was positively correlated with  Enhydrobacter , whereas  Enterobacteriaceae  was negatively correlated with TEWL in the NF group. These results suggest that GOS inhibit the growth of harmful skin microbes and increase the population of beneficial microbes.",2020,"Furthermore, the wrinkle depth and  Staphylococcus aureus  population decreased in the NF group compared with those in the ND group ( p  < 0.05).",[],"['cosmetic serum containing galacto-oligosaccharides (GOS', 'GOS', 'Prebiotic treatment', 'placebo']","['wrinkle depth and  Staphylococcus aureus  population', 'water-holding capacity', 'mean form factor, Shannon index, and  Pediococcus  population', 'transepidermal water loss (TEWL) and the erythema index', 'skin water-holding capacity']",[],"[{'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0028959', 'cui_str': 'Oligosaccharide'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0675390', 'cui_str': 'ARID1A protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030762', 'cui_str': 'Pediococcus'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",60.0,0.0290086,"Furthermore, the wrinkle depth and  Staphylococcus aureus  population decreased in the NF group compared with those in the ND group ( p  < 0.05).","[{'ForeName': 'Ki-Bae', 'Initials': 'KB', 'LastName': 'Hong', 'Affiliation': 'Department of Integrated Biomedical and Life Sciences, Graduate School, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Yang Hee', 'Initials': 'YH', 'LastName': 'Hong', 'Affiliation': ""Department of Beauty Art, Suwon Women's University, Suwon 16632, Korea.""}, {'ForeName': 'Eun Young', 'Initials': 'EY', 'LastName': 'Jung', 'Affiliation': 'Department of Home Economic Education, Jeonju University, Jeonju 55069, Korea.'}, {'ForeName': 'Kyungae', 'Initials': 'K', 'LastName': 'Jo', 'Affiliation': 'BK21Plus, College of Health Science, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Hyung Joo', 'Initials': 'HJ', 'LastName': 'Suh', 'Affiliation': 'Department of Integrated Biomedical and Life Sciences, Graduate School, Korea University, Seoul 02841, Korea.'}]",Journal of personalized medicine,['10.3390/jpm10030091']
2899,32824480,PHAGE-2 Study: Supplemental Bacteriophages Extend  Bifidobacterium animalis  subsp.  lactis  BL04 Benefits on Gut Health and Microbiota in Healthy Adults.,"Probiotics are increasingly used by consumers and practitioners to reduce gastrointestinal (GI) distress and improve gut function. Here, we sought to determine whether the addition of supplemental bacteriophages (PreforPro) could enhance the effects of a common probiotic,  Bifidobacterium animalis  subsp.  lactis  ( B. lactis ) on GI health. A total of 68 participants were enrolled in a 4-week, randomized, parallel-arm, double-blind, placebo-controlled trial where primary outcomes included self-assessments of GI health, a daily stool log, and 16s rRNA analysis of gut microbial populations. We observed within-group improvements in GI inflammation ( p  = 0.01) and a trending improvement in colon pain ( p  = 0.08) in individuals consuming  B. lactis  with PreforPro, but not in the group consuming only the probiotic. There was also a larger increase in  Lactobacillus  and short-chain fatty acid-producing microbial taxa detected in the stool of participants taking PreforPro with  B. lactis  compared to the probiotic alone. Overall, these results suggest the addition of PreforPro as a combination therapy may alter gut ecology to extend the GI benefits of consuming  B. lactis  or other probiotics.",2020,"We observed within-group improvements in GI inflammation ( p  = 0.01) and a trending improvement in colon pain ( p  = 0.08) in individuals consuming  B. lactis  with PreforPro, but not in the group consuming only the probiotic.","['A total of 68 participants', 'Healthy Adults']","['supplemental bacteriophages (PreforPro', 'PreforPro', 'placebo']","['colon pain', 'Lactobacillus  and short-chain fatty acid-producing microbial taxa', 'self-assessments of GI health, a daily stool log, and 16s rRNA analysis of gut microbial populations', 'GI inflammation', 'gastrointestinal (GI) distress and improve gut function']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0004651', 'cui_str': 'Bacterial virus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0035701', 'cui_str': 'Ribosomal RNA'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1535950', 'cui_str': 'Gastrointestinal inflammation'}, {'cui': 'C0548823', 'cui_str': 'Distress gastrointestinal'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",68.0,0.182107,"We observed within-group improvements in GI inflammation ( p  = 0.01) and a trending improvement in colon pain ( p  = 0.08) in individuals consuming  B. lactis  with PreforPro, but not in the group consuming only the probiotic.","[{'ForeName': 'Diana S', 'Initials': 'DS', 'LastName': 'Grubb', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Wrigley', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Kimberley E', 'Initials': 'KE', 'LastName': 'Freedman', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Yuren', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Allegra R', 'Initials': 'AR', 'LastName': 'Vazquez', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Roxanne E', 'Initials': 'RE', 'LastName': 'Trotter', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Taylor C', 'Initials': 'TC', 'LastName': 'Wallace', 'Affiliation': 'Think Healthy Group, 1301 20th Street, NW, #413, Washington, DC 20036, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Johnson', 'Affiliation': 'Functional Foods & Human Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}, {'ForeName': 'Tiffany L', 'Initials': 'TL', 'LastName': 'Weir', 'Affiliation': 'Intestinal Health Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, CO 80523, USA.'}]",Nutrients,['10.3390/nu12082474']
2900,32824483,"The Effect of Long-Term  Aronia   melanocarpa  Extract Supplementation on Cognitive Performance, Mood, and Vascular Function: A Randomized Controlled Trial in Healthy, Middle-Aged Individuals.","Cognitive decline is associated with lifestyle-related factors such as overweight, blood pressure, and dietary composition. Studies have reported beneficial effects of dietary anthocyanins on cognition in older adults and children. However, the effect of anthocyanin-rich  Aronia melanocarpa  extract (AME) on cognition is unknown. Therefore, this study aimed to determine the effect of long-term supplementation with AME on cognitive performance, mood, and vascular function in healthy, middle-aged, overweight adults. In a randomized double-blind placebo-controlled parallel study, 101 participants either consumed 90 mg AME, 150 mg AME, or placebo for 24 weeks. The grooved pegboard test, number cross-out test, and Stroop test were performed as measures for psychomotor speed, attention, and cognitive flexibility. Mood was evaluated with a visual analogue scale, serum brain-derived neurotrophic factor (BDNF) was determined, and vascular function was assessed by carotid ultrasounds and blood pressure measurements. AME improved psychomotor speed compared to placebo (90 mg AME: change = -3.37;  p  = 0.009). Furthermore, 150 mg AME decreased brachial diastolic blood pressure compared to 90 mg AME (change = 2.44;  p  = 0.011), but not compared to placebo. Attention, cognitive flexibility, BDNF, and other vascular parameters were not affected. In conclusion, AME supplementation showed an indication of beneficial effects on cognitive performance and blood pressure in individuals at risk of cognitive decline.",2020,AME improved psychomotor speed compared to placebo (90 mg AME: change = -3.37;  p  = 0.009).,"['individuals at risk of cognitive decline', 'older adults and children', 'Healthy, Middle-Aged Individuals', 'healthy, middle-aged, overweight adults', '101 participants either consumed 90 mg']","['Long-Term  Aronia   melanocarpa  Extract Supplementation', 'AME supplementation', 'anthocyanin-rich  Aronia melanocarpa  extract (AME', 'AME', 'dietary anthocyanins', 'AME, 150 mg AME, or placebo', 'placebo']","['Cognitive Performance, Mood, and Vascular Function', 'cognitive performance, mood, and vascular function', 'cognitive performance and blood pressure', 'AME improved psychomotor speed', 'carotid ultrasounds and blood pressure measurements', 'Attention, cognitive flexibility, BDNF, and other vascular parameters', 'psychomotor speed, attention, and cognitive flexibility', 'visual analogue scale, serum brain-derived neurotrophic factor (BDNF', 'brachial diastolic blood pressure']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1449661', 'cui_str': 'Aronia melanocarpa'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0066324', 'cui_str': 'methylamphotericin B'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0445456', 'cui_str': 'Brachial'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",101.0,0.34269,AME improved psychomotor speed compared to placebo (90 mg AME: change = -3.37;  p  = 0.009).,"[{'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Ahles', 'Affiliation': 'Department of Nutrition and Movement Sciences, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, 6200 MD Maastricht, The Netherlands.'}, {'ForeName': 'Yala R', 'Initials': 'YR', 'LastName': 'Stevens', 'Affiliation': 'BioActor BV, Gaetano Martinolaan 85, 6229 GS Maastricht, The Netherlands.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Joris', 'Affiliation': 'Department of Nutrition and Movement Sciences, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, 6200 MD Maastricht, The Netherlands.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vauzour', 'Affiliation': 'Biomedical Research Centre, Norwich Medical School, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich NR4 7TJ, UK.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Adam', 'Affiliation': 'Department of Nutrition and Movement Sciences, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, 6200 MD Maastricht, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'de Groot', 'Affiliation': 'Imagelabonline & Cardiovascular, 4117 GV Erichem, The Netherlands.'}, {'ForeName': 'Jogchum', 'Initials': 'J', 'LastName': 'Plat', 'Affiliation': 'Department of Nutrition and Movement Sciences, School of Nutrition and Translational Research in Metabolism (NUTRIM), Maastricht University, 6200 MD Maastricht, The Netherlands.'}]",Nutrients,['10.3390/nu12082475']
2901,32824709,Short and Long-Term Trainability in Older Adults: Training and Detraining Following Two Years of Multicomponent Cognitive-Physical Exercise Training.,"Despite the benefits of multicomponent physical-cognitive training programs (MC Cog TPs), lower training intensities in the concurrent approach, and bigger heterogeneity with aging, suggest the need for long-term analyses, with special attention to training and detraining in older adults. The present study aims to examine these training/detraining effects in a two year MC Cog TP, looking for specific dynamics in the trainability of their physical and cognitive capacities. The intervention was divided into four periods: T1, T2 (8 months of training each), and D1, D2 (3.5 months of detraining plus 0.5 of testing each). Twenty-five healthy seniors (70.82 ± 5.18 years) comprised the final sample and were assessed for cardiovascular fitness (6-minutes walking test), lower-limbs strength (30-seconds chair-stand test) and agility (8-feet timed up-and-go test). Inhibition (Stroop test) was considered for executive function. Physical and cognitive status improved significantly ( p  < 0.05) throughout the two years, with larger enhancements for physical function (mainly strength and agility). Strength and cardiovascular fitness were more sensitive to detraining, whilst agility proved to have larger training retentions. Inhibition followed an initial similar trend, but it was the only variable to improve along D2 (d = 0.52), and changes were not significant within periods. Notwithstanding aging, and the exercise cessation in D2, physical and cognitive status remained enhanced two years later compared to baseline, except for lower-limb strength. According to these results, basic physical capacities are very sensitive to training/detraining, deserving continuous attention (especially strength). Both reducing detraining periods and complementary resistance training should be considered. Additionally, physical enhancements following MC cog TPs may help cognition maintenance during detraining.",2020,"Physical and cognitive status improved significantly ( p  < 0.05) throughout the two years, with larger enhancements for physical function (mainly strength and agility).","['Older Adults', 'older adults', 'Twenty-five healthy seniors (70.82 ± 5.18 years']","['Training and Detraining Following Two Years of Multicomponent Cognitive-Physical Exercise Training', 'multicomponent physical-cognitive training programs (MC Cog TPs']","['Physical and cognitive status', 'cardiovascular fitness (6-minutes walking test), lower-limbs strength (30-seconds chair-stand test) and agility', 'Strength and cardiovascular fitness', 'physical function (mainly strength and agility', 'cognition maintenance', 'exercise cessation in D2, physical and cognitive status']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0289863', 'cui_str': 'tissue polypeptide specific antigen'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0179847', 'cui_str': 'Chair'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",25.0,0.0109849,"Physical and cognitive status improved significantly ( p  < 0.05) throughout the two years, with larger enhancements for physical function (mainly strength and agility).","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Blasco-Lafarga', 'Affiliation': 'Physical Education and Sports Department, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Cordellat', 'Affiliation': 'Physical Education and Sports Department, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Anabel', 'Initials': 'A', 'LastName': 'Forte', 'Affiliation': 'Statistics and Operational Research Department, University of Valencia, 46100 Burjassot, Valencia, Spain.'}, {'ForeName': 'Ainoa', 'Initials': 'A', 'LastName': 'Roldán', 'Affiliation': 'Physical Education and Sports Department, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Monteagudo', 'Affiliation': 'Sport Performance & Physical Fitness Research Group (UIRFIDE), University of Valencia, 46010 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17165984']
2902,32824720,"A Comparison of a Standard Macintosh Blade Laryngoscope, Pentax-AWS Videolaryngoscope and Intubrite Videolaryngoscope for Tracheal Intubation in Manikins in Sitting and Prone Positions: A Randomized Cross-Over Study.","BACKGROUND


Intubation of a patient in different positions may be done not only in emergency settings, but also in routine anesthesia (e.g., prone position for lumbar spine surgery).
METHODS


The aim of the study was to compare the classic Macintosh blade laryngoscope with two videolaryngoscopes: the Pentax-AWS and the Intubrite in a simulated scenario of a manikin placed in a sitting and prone position. Additionally, intubation with the use of all three devices was performed in a standard supine position as the control group. The time of intubation and the pressure exerted on the tongue was assessed. The ANOVA Friedman (analysis of variance) and Wilcoxon with Bonferroni correction tests were used for statistical analysis.
RESULTS


The time of intubation in a prone position was significantly shorter for the Pentax-AWS videolaryngoscope compared to the Macintosh and the Intubrite. There were no significant differences in the obtained results of the evaluated devices in sitting and standard positions. The lowest pressure exerted on the tongue was with the Pentax-AWS, followed by the Intubrite and the Macintosh laryngoscopes.
CONCLUSIONS


The use of the Pentax-AWS was associated with faster tracheal intubation, creating lower pressure on tongue when compared with standard Macintosh and Intubrite laryngoscopes in both prone and sitting positions.",2020,The time of intubation in a prone position was significantly shorter for the Pentax-AWS videolaryngoscope compared to the Macintosh and the Intubrite.,['Tracheal Intubation in Manikins in Sitting and Prone Positions'],"['Standard Macintosh Blade Laryngoscope, Pentax-AWS Videolaryngoscope and Intubrite Videolaryngoscope']","['time of intubation in a prone position', 'time of intubation and the pressure']","[{'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C3164607', 'cui_str': 'Videolaryngoscope'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0033422', 'cui_str': 'Prone body position'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",,0.0347406,The time of intubation in a prone position was significantly shorter for the Pentax-AWS videolaryngoscope compared to the Macintosh and the Intubrite.,"[{'ForeName': 'Tomasz M', 'Initials': 'TM', 'LastName': 'Gaszyński', 'Affiliation': 'Department of Anesthesiology and Intensive Therapy, Medical University of Lodz, 90-419 Lodz, Poland.'}]","Diagnostics (Basel, Switzerland)",['10.3390/diagnostics10080603']
2903,32824722,The Impact of a Multi-Pronged Intervention on Students' Perceptions of School Lunch Quality and Convenience and Self-Reported Fruit and Vegetable Consumption.,"School lunch programs provide an opportunity to improve students' diets. We sought to determine the impact of a multifaceted intervention (cafeteria redesigns, increased points-of-sale and teacher education) on secondary students' perceptions of school-lunch quality and convenience and fruit and vegetable intake. Surveys ( n  = 12,827) from middle and high school students in 12 intervention and 11 control schools were analyzed. We investigated change in school-lunch perceptions and lunchtime and daily fruit and vegetable consumption from 2016 to 2018. Among 8th graders, perceptions that school lunch tastes good and that school lunch was enough to make students feel full increased 0.2 points (on a 5-point scale;  p  < 0.01) in intervention schools relative to control schools. Among 10th graders, lunchtime fruit and vegetable consumption increased 6% in intervention relative to control schools ( p  < 0.05 and  p  < 0.01 respectively). Daily fruit intake increased 0.1 cups/day in intervention relative to control schools among 9th graders ( p  < 0.01). This study provides important evidence on the limited effect of design approaches in the absence of meal changes. We observed only modest changes in school lunch perceptions and fruit and vegetable consumption that were not consistent across grades, suggesting that additional efforts are needed to improve school-lunch uptake.",2020,Daily fruit intake increased 0.1 cups/day in intervention relative to control schools among 9th graders ( p  < 0.01).,"['Surveys ( n  = 12,827) from middle and high school students in 12 intervention and 11 control schools were analyzed', ""students' diets""]","['Multi-Pronged Intervention', 'multifaceted intervention (cafeteria redesigns, increased points-of-sale and teacher education']","['lunchtime fruit and vegetable consumption', 'school-lunch uptake', 'Daily fruit intake', 'school-lunch perceptions and lunchtime and daily fruit and vegetable consumption', 'school lunch perceptions and fruit and vegetable consumption', 'school-lunch quality and convenience and fruit and vegetable intake', 'School Lunch Quality and Convenience and Self-Reported Fruit and Vegetable Consumption']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0036070', 'cui_str': 'Sales'}, {'cui': 'C0871930', 'cui_str': 'Teacher Education'}]","[{'cui': 'C0585039', 'cui_str': 'Lunch time'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C2697949', 'cui_str': 'Lunch'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0556227', 'cui_str': 'Fruit intake'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",,0.0183678,Daily fruit intake increased 0.1 cups/day in intervention relative to control schools among 9th graders ( p  < 0.01).,"[{'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Machado', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA 94704, USA.'}, {'ForeName': 'Lorrene D', 'Initials': 'LD', 'LastName': 'Ritchie', 'Affiliation': 'Nutrition Policy Institute, University of California Agriculture and Natural Resources, Berkeley, CA 94704, USA.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Thompson', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA 94704, USA.'}, {'ForeName': 'Kristine A', 'Initials': 'KA', 'LastName': 'Madsen', 'Affiliation': 'School of Public Health, University of California, Berkeley, CA 94704, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17165987']
2904,32824731,A Guide to Nature Immersion: Psychological and Physiological Benefits.,"Nature exposure has been renowned for its positive physiological and psychological benefits. Recent years have seen a rise in nature immersion programs that make use of Guided Forest Therapy walks in a standard sequence of sensory awareness activities to expose participants to natural environments in a safe but effective manner. The study aimed to compare the efficacy of guided versus unguided nature immersion, upon three dependent variables of mood, nature connectedness and heartrate. 51 participants were assigned to either guided or unguided nature immersion. Nature connectedness (Connectedness to Nature Scale, CNS), Environmental Identity Scale, EID short form) and mood (Positive and Negative Affect Scale, PANAS) were assessed before and after nature immersion, while heart rate was tracked continuously by a wristwatch heart rate tracker throughout the 2-h experience. Demographics and general health practice (GHP) information were also collected. A mixed model ANOVA revealed that nature connectedness and mood (but not heart rate) improved post-immersion for all participants. Comparing the guided/unguided conditions, there were no significant differences in the change in nature connectedness, mood or heart rate. Comparing within the five segments within the standard sequence in the guided condition, the third and fifth segments revealed a significantly lower heart rate compared to the baseline heart rate.",2020,"Comparing the guided/unguided conditions, there were no significant differences in the change in nature connectedness, mood or heart rate.",['51 participants'],"['guided or unguided nature immersion', 'guided versus unguided nature immersion']","['Nature connectedness (Connectedness to Nature Scale, CNS), Environmental Identity Scale, EID short form) and mood (Positive and Negative Affect Scale, PANAS', 'Demographics and general health practice (GHP) information', 'nature connectedness, mood or heart rate', 'heart rate']",[],"[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]","[{'cui': 'C0349590', 'cui_str': 'Nature'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0424215', 'cui_str': 'Sense of identity'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",51.0,0.0195299,"Comparing the guided/unguided conditions, there were no significant differences in the change in nature connectedness, mood or heart rate.","[{'ForeName': 'Pei Yi', 'Initials': 'PY', 'LastName': 'Lim', 'Affiliation': 'Psychology Department, James Cook University, Singapore 387380, Singapore.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Dillon', 'Affiliation': 'Psychology Department, James Cook University, Singapore 387380, Singapore.'}, {'ForeName': 'Peter K H', 'Initials': 'PKH', 'LastName': 'Chew', 'Affiliation': 'Psychology Department, James Cook University, Singapore 387380, Singapore.'}]",International journal of environmental research and public health,['10.3390/ijerph17165989']
2905,32824736,"The Impact of Formulation on Lutein, Zeaxanthin, and  meso -Zeaxanthin Bioavailability: A Randomised Double-Blind Placebo-Controlled Study.","Lutein (L), zeaxanthin (Z), and  meso -zeaxanthin (MZ) have been the focus of research and commercial interest for their applications in human health. Research into formulations to enhance their bioavailability is merited. This 6 month randomised placebo-controlled trial involving 81 healthy volunteers compared the bioavailability of different formulations of free L, Z, and MZ in sunflower or omega-3 oil versus L, Z, and MZ diacetates (Ld, Zd, and MZd) in a micromicellar formulation. Fasting serum carotenoids, macular pigment, and skin carotenoid score were analysed at baseline and 6 months. Serum L, Z, and MZ concentrations increased in all active interventions compared to placebo ( p  < 0.001 to  p  = 0.008). The diacetate micromicelle formulation exhibited a significantly higher mean response in serum concentrations of Z and MZ compared to the other active interventions ( p  = 0.002 to 0.019). A micromicellar formulation with solubilised Z and MZ diacetates is a promising technology advancement that enhances the bioavailability of these carotenoids when compared to traditional carotenoid formulations (ISRCTN clinical trial registration number: ISRCTN18206561).",2020,"Serum L, Z, and MZ concentrations increased in all active interventions compared to placebo ( p  < 0.001 to  p  = 0.008).",['81 healthy volunteers'],"['placebo', 'free L, Z, and MZ in sunflower or omega-3 oil versus L, Z, and MZ diacetates (Ld, Zd, and MZd', 'Placebo', 'Lutein (L), zeaxanthin (Z), and  meso -zeaxanthin (MZ']","['Fasting serum carotenoids, macular pigment, and skin carotenoid score', 'Lutein, Zeaxanthin, and  meso -Zeaxanthin Bioavailability', 'serum concentrations of Z and MZ', 'Serum L, Z, and MZ concentrations']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0947381', 'cui_str': 'Helianthus annuus'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C3884591', 'cui_str': 'meso-zeaxanthin'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C3850163', 'cui_str': 'Macular Pigment'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043328', 'cui_str': 'Lutein'}, {'cui': 'C0078752', 'cui_str': 'zeaxanthin'}, {'cui': 'C3884591', 'cui_str': 'meso-zeaxanthin'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",81.0,0.131769,"Serum L, Z, and MZ concentrations increased in all active interventions compared to placebo ( p  < 0.001 to  p  = 0.008).","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Green-Gomez', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 X236 Waterford, Ireland.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Prado-Cabrero', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 X236 Waterford, Ireland.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Moran', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 X236 Waterford, Ireland.'}, {'ForeName': 'Tommy', 'Initials': 'T', 'LastName': 'Power', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 X236 Waterford, Ireland.'}, {'ForeName': 'Laura G', 'Initials': 'LG', 'LastName': 'Gómez-Mascaraque', 'Affiliation': 'Teagasc Food Research Centre, Moorepark, Fermoy, P61 C996 Co. Cork, Ireland.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Stack', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 X236 Waterford, Ireland.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Nolan', 'Affiliation': 'Nutrition Research Centre Ireland, School of Health Sciences, Carriganore House, Waterford Institute of Technology West Campus, X91 X236 Waterford, Ireland.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9080767']
2906,32824771,High-Flow Oxygen through Nasal Cannula vs. Non-Invasive Ventilation in Hypercapnic Respiratory Failure: A Randomized Clinical Trial.,"High-flow oxygen through nasal cannula (HFNC) provides adequate oxygenation and can be an alternative to noninvasive ventilation (NIV) for patients with hypoxemic respiratory failure. The aim of the present study was to assess the efficacy of HFNC versus NIV in hypercapnic respiratory failure. Patients (n = 40) who were admitted to the Emergency Department of Alexandra Hospital due to hypercapnic respiratory failure (PaCO 2  ≥ 45 mmHg) were randomized assigned into two groups, i.e., an intervention group (use of HFNC, n = 20) and a control group (use of NIV, n = 20). During their hospitalization in the Intensive Care Unit, vital signs (respiratory and heart rate, arterial blood pressure) and arterial blood gases (ABG) were closely monitored on admission, after 24 h and at discharge. No difference between the two groups regarding the duration of hospitalization and the use of HFNC or NIV was observed ( p  > 0.05). On admission, the two groups did not differ in terms of gender, age, body mass index, APACHE score, predicted death rate, heart rate, arterial blood pressure and arterial blood gases ( p  > 0.05). Respiratory rate in the HFNC group was lower than in the NIV group ( p  = 0.023). At discharge, partial carbon dioxide arterial pressure (PaCO 2 ) in the HFNC group was lower than in the NIV group (50.8 ± 9.4 mmHg versus 59.6 ± 13.9 mmHg,  p  = 0.024). The lowerPaCO 2  in the HFNC group than in the NIV group indicated that HFNC was superior to NIV in the management of hypercapnic respiratory failure.",2020,The lowerPaCO 2  in the HFNC group than in the NIV group indicated that HFNC was superior to NIV in the management of hypercapnic respiratory failure.,"['patients with hypoxemic respiratory failure', '45 mmHg', 'Hypercapnic Respiratory Failure', 'hypercapnic respiratory failure', 'Patients (n = 40) who were admitted to the Emergency Department of Alexandra Hospital due to hypercapnic respiratory failure (PaCO 2  ≥']","['High-flow oxygen through nasal cannula (HFNC', 'High-Flow Oxygen through Nasal Cannula vs. Non-Invasive Ventilation', 'HFNC']","['partial carbon dioxide arterial pressure (PaCO 2 ', 'duration of hospitalization and the use of HFNC or NIV', 'vital signs (respiratory and heart rate, arterial blood pressure) and arterial blood gases (ABG', 'body mass index, APACHE score, predicted death rate, heart rate, arterial blood pressure and arterial blood gases', 'Respiratory rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340194', 'cui_str': 'Respiratory failure without hypercapnia'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0398353', 'cui_str': 'Hypercapnic respiratory failure'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1272641', 'cui_str': 'Systemic arterial pressure'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0243030', 'cui_str': 'Acute physiology and chronic health evaluation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",,0.0542864,The lowerPaCO 2  in the HFNC group than in the NIV group indicated that HFNC was superior to NIV in the management of hypercapnic respiratory failure.,"[{'ForeName': 'Yiannis', 'Initials': 'Y', 'LastName': 'Papachatzakis', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra Hospital, 11527 Athens, Greece.'}, {'ForeName': 'Pantelis Theodoros', 'Initials': 'PT', 'LastName': 'Nikolaidis', 'Affiliation': 'Department of Occupational Therapy, School of Health and Caring Sciences, University of West Attica, 12243 Athens, Greece.'}, {'ForeName': 'Sofoklis', 'Initials': 'S', 'LastName': 'Kontogiannis', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra Hospital, 11527 Athens, Greece.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Trakada', 'Affiliation': 'Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra Hospital, 11527 Athens, Greece.'}]",International journal of environmental research and public health,['10.3390/ijerph17165994']
2907,32824920,Can Creatine Supplementation Interfere with Muscle Strength and Fatigue in Brazilian National Level Paralympic Powerlifting?,"The aim of the present study was to analyze the effect of creatine (Cr) supplementation on peak torque (PT) and fatigue rate in Paralympic weightlifting athletes. Eight Paralympic powerlifting athletes participated in the study, with 25.40 ± 3.30 years and 70.30 ± 12.15 kg. The measurements of muscle strength, fatigue index (FI), peak torque (PT), force (kgf), force (N), rate of force development (RFD), and time to maximum isometric force (time) were determined by a Musclelab load cell. The study was performed in a single-blind manner, with subjects conducting the experiments first with placebo supplementation and then, following a 7-day washout period, beginning the same protocol with creatine supplementation for 7 days. This sequence was chosen because of the lengthy washout of creatine. Regarding the comparison between conditions, Cr supplementation did not show effects on the variables of muscle force, peak torque, RFD, and time to maximum isometric force ( p  > 0.05). However, when comparing the results of the moments with the use of Cr and placebo, a difference was observed for the FI after seven days (U 3 : 1.12; 95% CI: (0.03, 2.27);  p  = 0.02); therefore, the FI was higher for placebo. Creatine supplementation has a positive effect on the performance of Paralympic powerlifting athletes, reducing fatigue index, and keeping the force levels as well as PT.",2020,"Regarding the comparison between conditions, Cr supplementation did not show effects on the variables of muscle force, peak torque, RFD, and time to maximum isometric force ( p  > 0.05).","['Paralympic weightlifting athletes', 'Eight Paralympic powerlifting athletes participated in the study, with 25.40 ± 3.30 years and 70.30 ± 12.15 kg']","['placebo', 'Creatine supplementation', 'creatine (Cr) supplementation', 'placebo supplementation']","['muscle strength, fatigue index (FI), peak torque (PT), force (kgf), force (N), rate of force development (RFD), and time to maximum isometric force (time', 'muscle force, peak torque, RFD, and time to maximum isometric force', 'peak torque (PT) and fatigue rate']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",,0.0998311,"Regarding the comparison between conditions, Cr supplementation did not show effects on the variables of muscle force, peak torque, RFD, and time to maximum isometric force ( p  > 0.05).","[{'ForeName': 'Carlos Rodrigo', 'Initials': 'CR', 'LastName': 'Soares Freitas Sampaio', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Felipe J', 'Initials': 'FJ', 'LastName': 'Aidar', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Alexandre R P', 'Initials': 'ARP', 'LastName': 'Ferreira', 'Affiliation': 'College of Physical Education and Exercise Science, University of Brasília (UnB), Brasília 70910-900, Brazil.'}, {'ForeName': 'Jymmys Lopes Dos', 'Initials': 'JLD', 'LastName': 'Santos', 'Affiliation': 'Program in Biotechnology, Northeast Network in Biotechnology (RENORBIO), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Anderson Carlos', 'Initials': 'AC', 'LastName': 'Marçal', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Dihogo Gama de', 'Initials': 'DG', 'LastName': 'Matos', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Raphael Fabrício de', 'Initials': 'RF', 'LastName': 'Souza', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports (GPEPS), Federal University of Sergipe (UFS), São Cristovão 49100-000, Sergipe, Brazil.'}, {'ForeName': 'Osvaldo Costa', 'Initials': 'OC', 'LastName': 'Moreira', 'Affiliation': 'Institute of Biological Sciences and Health, Federal University of Viçosa, Campus Florestal, Minas Gerais 35690-000, Brazil.'}, {'ForeName': 'Ialuska', 'Initials': 'I', 'LastName': 'Guerra', 'Affiliation': 'Federal Institute of Education, Science and Technology of Ceará (IFCE), Campus of Juazeiro do Norte, Ceará 63040-540, Brazil.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Fernandes Filho', 'Affiliation': 'Brazilian Paralympic Academy, Brazilian Paralympic Committee, São Paulo 04329-000, SP, Brazil.'}, {'ForeName': 'Lucas Soares', 'Initials': 'LS', 'LastName': 'Marcucci-Barbosa', 'Affiliation': 'Laboratory of Inflammation and Exercise Immunology, Sports Center, Physical Education Scholl, Federal University of OuroPreto (UFOP), OuroPreto, Minas Gerais 35400-000, Brazil.'}, {'ForeName': 'Albená', 'Initials': 'A', 'LastName': 'Nunes-Silva', 'Affiliation': 'Laboratory of Inflammation and Exercise Immunology, Sports Center, Physical Education Scholl, Federal University of OuroPreto (UFOP), OuroPreto, Minas Gerais 35400-000, Brazil.'}, {'ForeName': 'Paulo Francisco de', 'Initials': 'PF', 'LastName': 'Almeida-Neto', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte (UFRN), Natal, Rio Grande do Norte 59078-970, Brazil.'}, {'ForeName': 'Breno Guilherme Araújo Tinoco', 'Initials': 'BGAT', 'LastName': 'Cabral', 'Affiliation': 'Department of Physical Education, Federal University of Rio Grande do Norte (UFRN), Natal, Rio Grande do Norte 59078-970, Brazil.'}, {'ForeName': 'Victor Machado', 'Initials': 'VM', 'LastName': 'Reis', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), Trásos Montes and Alto Douro University, 5001-801 Vila Real, Portugal.'}]",Nutrients,['10.3390/nu12092492']
2908,32824994,Exploring Perceptions of Internet-Delivered Cognitive Behaviour Therapy among Public Safety Personnel: Informing Dissemination Efforts.,"Background  Public safety personnel (PSP) experience high rates of mental health disorders but have limited access to treatment. To improve treatment access, there is a growing interest in offering internet-delivered cognitive behaviour therapy (ICBT) to PSP. As attitudes towards ICBT can both impact and inform ICBT implementation efforts, this study examines perceptions of ICBT among PSP who viewed a poster (a commonly used method of advertising ICBT) or a poster supplemented with a story of a PSP who benefitted from ICBT.  Methods  Participants ( N  = 132) from various PSP sectors were randomly assigned to view a poster or a poster and a story. Participants then completed an online survey assessing their perceptions of ICBT using both qualitative and quantitative questions. We used a mixed-methods approach to analyze the data.  Results  No differences in perceptions of ICBT were identified between the conditions. Ratings of credibility, treatment expectancy, anticipated treatment adherence, and acceptability suggested that PSP had positive perceptions of ICBT. Most participants (93%) reported that they would access ICBT if they needed help with mental health concerns. Participants ranked therapist-guided ICBT as their second most preferred treatment, with psychologists ranked first. Female participants found ICBT more credible than male participants. More experienced PSP reported lower acceptability and anticipated adherence to ICBT.  Conclusions  The findings suggest that many PSP are likely to be receptive to ICBT even when a simple poster is used as a method of informing PSP of this treatment option. Further attention to improving the perceptions of ICBT among certain groups may be warranted.",2020,No differences in perceptions of ICBT were identified between the conditions.,"['Female participants found ICBT more credible than male participants', 'Methods  Participants ( N  = 132) from various PSP sectors']",['Internet-Delivered Cognitive Behaviour Therapy'],"['Ratings of credibility, treatment expectancy', 'perceptions of ICBT']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0038868', 'cui_str': 'Progressive supranuclear palsy'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.0686862,No differences in perceptions of ICBT were identified between the conditions.,"[{'ForeName': 'Hugh C', 'Initials': 'HC', 'LastName': 'McCall', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'Angelo P', 'Initials': 'AP', 'LastName': 'Sison', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'Jody L', 'Initials': 'JL', 'LastName': 'Burnett', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'Janine D', 'Initials': 'JD', 'LastName': 'Beahm', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK S4S 0A2, Canada.'}, {'ForeName': 'Heather D', 'Initials': 'HD', 'LastName': 'Hadjistavropoulos', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Pkwy, Regina, SK S4S 0A2, Canada.'}]",International journal of environmental research and public health,['10.3390/ijerph17176026']
2909,32825020,"Comparative Indoor Pollution from Glo, Iqos, and Juul, Using Traditional Combustion Cigarettes as Benchmark: Evidence from the Randomized SUR-VAPES AIR Trial.","Modified risk products (MRP) such as electronic vaping cigarettes (EVC) and heat-not-burn cigarettes (HNBC) are appealing alternatives to combustion cigarettes. Limited between- and within-device comparative data are available on MRP. We aimed at comparing indoor particulate matter (PM) emissions measured in a randomized trial enforcing standardized smoking sessions, testing different devices and flavors of MRP, using traditional combustion cigarettes (TCC) as benchmark. Overall, MRP yielded significantly lower levels of indoor PM in comparison to TCC (with median PM levels during smoking for MRP < 100 μg/m 3 , and for TCC > 1000 μg/m 3 ). Despite this, significant differences among MRP were found, with Iqos appearing associated with a significantly lower burden of emissions for all the monitored fractions of PM, including total PM (all  p  < 0.05). Precisely, during use, PM ≤1 µm (PM 1 ) emissions were 28 (16; 28) μg/m 3  for Glo, 25 (15; 57) μg/m 3  for Iqos, and 73 (15; 559) μg/m 3  for Juul ( p  < 0.001 for Glo vs. Iqos,  p  < 0.001 for Glo vs. Juul, and  p  = 0.045 for Iqos vs. Juul). Exploratory within-MRP analyses suggested significant differences between flavors, favoring, for instance, Ultramarine for Glo, Bronze for Iqos, and Mango for Juul, even if results varied substantially according to individual smoker. In conclusion, leading MRP have significantly less intense and persistent effects on indoor pollution in comparison to TCC. Yet, when focusing solely on MRP, between-product and between-flavor differences appear, with quantitative estimates suggesting lower polluting effects with Iqos. These results, if confirmed externally, could be used to individualize product and flavor choice to minimize the untoward effects of EVC and HNBC on indoor pollution.",2020,"Overall, MRP yielded significantly lower levels of indoor PM in comparison to TCC (with median PM levels during smoking for MRP",[],"['MRP', 'traditional combustion cigarettes (TCC', 'indoor particulate matter (PM) emissions', 'TCC', 'Modified risk products (MRP) such as electronic vaping cigarettes (EVC) and heat-not-burn cigarettes (HNBC']","['burden of emissions', 'total PM']",[],"[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0077072', 'cui_str': 'triclocarban'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0455956', 'cui_str': 'Cigarette burn'}]","[{'cui': 'C0233929', 'cui_str': 'Emission'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0436517,"Overall, MRP yielded significantly lower levels of indoor PM in comparison to TCC (with median PM levels during smoking for MRP","[{'ForeName': 'Mariangela', 'Initials': 'M', 'LastName': 'Peruzzi', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Cavarretta', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Frati', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Carnevale', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Miraldi', 'Affiliation': 'Department of Clinical, Internal Medicine, Anesthesiology and Cardiovascular Sciences, Sapienza University of Rome, Viale Del Policlinico 155, 00161 Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Biondi-Zoccai', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Sebastiano', 'Initials': 'S', 'LastName': 'Sciarretta', 'Affiliation': 'Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Corso della Repubblica 74, 04100 Latina, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Versaci', 'Affiliation': 'UOC UTIC Emodinamica e Cardiologia, Ospedale Santa Maria Goretti, Via Antonio Canova, 04100 Latina, Italy.'}, {'ForeName': 'Vittoria', 'Initials': 'V', 'LastName': 'Cammalleri', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Avino', 'Affiliation': 'Department of Agricultural, Environmental and Food Sciences (DiAAA), University of Molise, via De Sanctis, 86100 Campobasso, Italy.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Protano', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Vitali', 'Affiliation': 'Department of Public Health and Infectious Diseases, Sapienza University of Rome, 00185 Rome, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17176029']
2910,32044511,Neoadjuvant Chemotherapy With Anthracycline-Based Regimen for BRCAness Tumors in Triple-Negative Breast Cancer.,"BACKGROUND


A subgroup of triple-negative breast cancer (TNBC) shows impaired BRCA1 function owing to causes other than mutation, which is called ""BRCAness."" DNA-damaging agents are known to have more efficacy in BRCA1-mutant tumors than mitotic poisons. We conducted a prospective single-arm clinical trial of neoadjuvant chemotherapy (NAC) using an anthracycline-based regimen without taxanes for BRCAness TNBCs.
MATERIALS AND METHODS


BRCAness was examined using the multiplex ligation-dependent probe amplification (MLPA) method in TNBC cases. For BRCAness cases, NAC was performed with anthracycline-based regimens without additional taxanes.
RESULTS


A total of 30 patients with TNBC were enrolled. MLPA was successfully performed in 25 patients. Eighteen patients (72%) showed BRCAness. Twenty-three patients received NAC as per the protocol. On analysis, the clinical response rate (complete response plus partial response) was 76.4%, and the pathological complete response rate was 35.3%.
CONCLUSIONS


The interim analysis revealed that the pathological complete response rate was lower than estimated. Therefore, BRCAness by MLPA was not sufficient to predict the therapeutic response to anthracycline-based regimens in TNBC.",2020,"On analysis, the clinical response rate (complete response plus partial response) was 76.4%, and the pathological complete response rate was 35.3%.
","['30 patients with TNBC were enrolled', 'BRCAness Tumors in Triple-Negative Breast Cancer', '25 patients', 'BRCAness was examined using the multiplex ligation-dependent probe amplification (MLPA) method in TNBC cases']","['anthracycline-based regimens without additional taxanes', 'MLPA', 'NAC', 'neoadjuvant chemotherapy (NAC', 'anthracycline-based regimen without taxanes', 'Neoadjuvant Chemotherapy With Anthracycline-Based Regimen']","['pathological complete response rate', 'clinical response rate (complete response plus partial response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C3494189', 'cui_str': 'Multiplex Ligation-Dependent Probe Amplification'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0868928', 'cui_str': 'Case'}]","[{'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C3494189', 'cui_str': 'Multiplex Ligation-Dependent Probe Amplification'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}]",30.0,0.0250821,"On analysis, the clinical response rate (complete response plus partial response) was 76.4%, and the pathological complete response rate was 35.3%.
","[{'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Teraoka', 'Affiliation': 'Department of Breast Oncology and Surgery, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Sato', 'Affiliation': 'Department of Pathology, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Narui', 'Affiliation': 'Department of Breast Surgery, Yokohama City University Medical Center, Yokohama-shi, Kanagawa, Japan.'}, {'ForeName': 'Akimitsu', 'Initials': 'A', 'LastName': 'Yamada', 'Affiliation': 'Department of Breast Surgery, Chigasaki Medical Hospital, Chigasaki-shi, Kanagawa, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Fujita', 'Affiliation': 'Department of Breast and Thyroid Surgery, Tokyo Medical University Ibaraki Medical Center, Inashikigun, Ibaraki, Japan.'}, {'ForeName': 'Kimito', 'Initials': 'K', 'LastName': 'Yamada', 'Affiliation': 'Department of Breast Oncology and Surgery, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Oba', 'Affiliation': 'Department of Medical Statistics, Faculty of Medicine, Toho University, Ota-ku, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Breast Oncology and Surgery, Tokyo Medical University, Shinjuku-ku, Tokyo, Japan. Electronic address: tishik55@gmail.com.'}]",The Journal of surgical research,['10.1016/j.jss.2019.12.047']
2911,32058550,Assessment of Treatment Effect With Multiple Outcomes in 2 Clinical Trials of Patients With Duchenne Muscular Dystrophy.,,2020,,['Patients With Duchenne Muscular Dystrophy'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}]",[],[],,0.080363,,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'McDonald', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Department of Pediatrics, University of California Davis, Sacramento.'}, {'ForeName': 'Gary L', 'Initials': 'GL', 'LastName': 'Elfring', 'Affiliation': 'PTC Therapeutics, South Plainfield, New Jersey.'}, {'ForeName': 'Marcio', 'Initials': 'M', 'LastName': 'Souza', 'Affiliation': 'PTC Therapeutics, South Plainfield, New Jersey.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'McIntosh', 'Affiliation': 'PTC Therapeutics, South Plainfield, New Jersey.'}, {'ForeName': 'Dae Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lee-Jen', 'Initials': 'LJ', 'LastName': 'Wei', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.21306']
2912,31752607,Are Celebrities Really Admired for Their Morality?,"This study examines whether the admiration of celebrities is the same or different from admiration of other persons. The  Multidimensional Admiration Scale , Rubin's  Liking Scale , and the  Celebrity Attitude Scale  were administered to 190 participants from four American universities. Participants were randomly assigned to fill out either the ""most admired person"" version or the ""favorite celebrity"" version ( n  =   96) of the three scales. We hypothesized that the Multidimensional Admiration Scale is a valid measure of admiration for individuals who are familiar with the morality of the target person, but is invalid for measuring admiration for celebrities. Arguably, this is partly because celebrities are admired mostly for their ability to entertain, and not their morality, which is often unknown or little is known to their fans. The results generally confirmed our hypotheses. The Multidimensional Admiration Scale was not intended as a measure of admiration for celebrities and is not recommended to be used for that purpose.",2020,"The  Multidimensional Admiration Scale , Rubin's  Liking Scale , and the  Celebrity Attitude Scale  were administered to 190 participants from four American universities.",['190 participants from four American universities'],"['most admired person"" version or the ""favorite celebrity"" version']","[""Multidimensional Admiration Scale , Rubin's  Liking Scale , and the  Celebrity Attitude Scale""]","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0015621', 'cui_str': 'Famous Persons'}]","[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0252873', 'cui_str': 'Fuchsin acid stain'}, {'cui': 'C0015621', 'cui_str': 'Famous Persons'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",190.0,0.0179681,"The  Multidimensional Admiration Scale , Rubin's  Liking Scale , and the  Celebrity Attitude Scale  were administered to 190 participants from four American universities.","[{'ForeName': 'Blaine L', 'Initials': 'BL', 'LastName': 'Browne', 'Affiliation': 'Valdosta State University, GA, USA.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'McCutcheon', 'Affiliation': 'Editor, North American Journal of Psychology.'}, {'ForeName': 'Mara S', 'Initials': 'MS', 'LastName': 'Aruguete', 'Affiliation': 'Lincoln University, MO, USA.'}, {'ForeName': 'Bethany S', 'Initials': 'BS', 'LastName': 'Jurs', 'Affiliation': 'Transylvania University, KY, USA.'}, {'ForeName': 'Drew A', 'Initials': 'DA', 'LastName': 'Curtis', 'Affiliation': 'Angelo State University, TX, USA.'}]",Psychological reports,['10.1177/0033294119889585']
2913,31918406,The Association Between Time-Use Behaviors and Physical and Mental Well-Being in Adults: A Compositional Isotemporal Substitution Analysis.,"BACKGROUND


Substantial evidence links activity domains with health and well-being; however, research has typically examined time-use behaviors independently, rather than considering daily activity as a 24-hour time-use composition. This study used compositional data analysis to estimate the difference in physical and mental well-being associated with reallocating time between behaviors.
METHODS


Participants (n = 430; 74% female; 41 [12] y) wore an accelerometer for 7 days and reported their body mass index; health-related quality of life (QoL); and symptoms of depression, anxiety, and stress. Regression models determined whether time-use composition, comprising sleep, sedentary behavior, light physical activity (LPA), and moderate to vigorous physical activity (MVPA), was associated with well-being. Compositional isotemporal substitution models estimated the difference in well-being associated with reallocating time between behaviors.
RESULTS


Time-use composition was associated with body mass index and physical health-related QoL. Reallocating time to MVPA from sleep, sedentary behavior, and LPA showed favorable associations with body mass index and physical health-related QoL, whereas reallocations from MVPA to other behaviors showed unfavorable associations. Reallocations from LPA to sedentary behavior were associated with better physical health-related QoL and vice versa.
CONCLUSION


Results reinforce the importance of MVPA for physical health but do not suggest that replacing sedentary behavior with LPA is beneficial for health and well-being.",2020,"RESULTS


Time-use composition was associated with body mass index and physical health-related QoL. Reallocating time to MVPA from sleep, sedentary behavior, and LPA showed favorable associations with body mass index and physical health-related QoL, whereas reallocations from MVPA to other behaviors showed unfavorable associations.","['Adults', 'Participants (n = 430; 74% female; 41 [12]\xa0y']",[],"['body mass index; health-related quality of life (QoL); and symptoms of depression, anxiety, and stress', 'time-use composition, comprising sleep, sedentary behavior, light physical activity (LPA), and moderate to vigorous physical activity (MVPA']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.0264566,"RESULTS


Time-use composition was associated with body mass index and physical health-related QoL. Reallocating time to MVPA from sleep, sedentary behavior, and LPA showed favorable associations with body mass index and physical health-related QoL, whereas reallocations from MVPA to other behaviors showed unfavorable associations.","[{'ForeName': 'Rachel G', 'Initials': 'RG', 'LastName': 'Curtis', 'Affiliation': ''}, {'ForeName': 'Dorothea', 'Initials': 'D', 'LastName': 'Dumuid', 'Affiliation': ''}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Olds', 'Affiliation': ''}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Plotnikoff', 'Affiliation': ''}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Vandelanotte', 'Affiliation': ''}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Ryan', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Edney', 'Affiliation': ''}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Maher', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0687']
2914,32817311,Vitamin K Supplementation to Improve Vascular Stiffness in CKD: The K4Kidneys Randomized Controlled Trial.,"BACKGROUND


Vascular calcification, a risk factor for cardiovascular disease, is common among patients with CKD and is an independent contributor to increased vascular stiffness and vascular risk in this patient group. Vitamin K is a cofactor for proteins involved in prevention of vascular calcification. Whether or not vitamin K supplementation could improve arterial stiffness in patients with CKD is unknown.
METHODS


To determine if vitamin K supplementation might improve arterial stiffness in patients in CKD, we conducted a parallel-group, double-blind, randomized trial in participants aged 18 or older with CKD stage 3b or 4 (eGFR 15-45 ml/min per 1.73 m 2 ). We randomly assigned participants to receive 400  μ g oral vitamin K2 or matching placebo once daily for a year. The primary outcome was the adjusted between-group difference in carotid-femoral pulse wave velocity at 12 months. Secondary outcomes included augmentation index, abdominal aortic calcification, BP, physical function, and blood markers of mineral metabolism and vascular health. We also updated a recently published meta-analysis of trials to include the findings of this study.
RESULTS


We included 159 randomized participants in the modified intention-to-treat analysis, with 80 allocated to receive vitamin K and 79 to receive placebo. Mean age was 66 years, 62 (39%) were female, and 87 (55%) had CKD stage 4. We found no differences in pulse wave velocity at 12 months, augmentation index at 12 months, BP, B-type natriuretic peptide, or physical function. The updated meta-analysis showed no effect of vitamin K supplementation on vascular stiffness or vascular calcification measures.
CONCLUSIONS


Vitamin K2 supplementation did not improve vascular stiffness or other measures of vascular health in this trial involving individuals with CKD.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER


Vitamin K therapy to improve vascular health in patients with chronic kidney disease, ISRCTN21444964 (www.isrctn.com).",2020,"CONCLUSIONS


Vitamin K2 supplementation did not improve vascular stiffness or other measures of vascular health in this trial involving individuals with CKD.
","['participants aged 18 or older with CKD stage 3b or 4 (eGFR 15-45 ml/min per 1.73 m 2 ', 'CKD', 'patients with chronic kidney disease, ISRCTN21444964 (www.isrctn.com', 'individuals with CKD', 'patients with CKD', '159 randomized participants in the modified intention-to-treat analysis, with 80 allocated to receive', 'Mean age was 66 years, 62 (39%) were female, and 87 (55%) had CKD stage 4', 'patients in CKD']","['Vitamin K', 'Vitamin K Supplementation', 'Vitamin K2 supplementation', 'vitamin K supplementation', 'vitamin K and 79 to receive placebo', '400  μ', 'g oral vitamin K2 or matching placebo']","['arterial stiffness', 'carotid-femoral pulse wave velocity', 'augmentation index, abdominal aortic calcification, BP, physical function, and blood markers of mineral metabolism and vascular health', 'pulse wave velocity at 12 months, augmentation index at 12 months, BP, B-type natriuretic peptide, or physical function', 'vascular stiffness', 'vascular health', 'vascular stiffness or vascular calcification measures']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2317473', 'cui_str': 'Chronic kidney disease stage 4'}]","[{'cui': 'C0042878', 'cui_str': 'Vitamin K'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C1096249', 'cui_str': 'Aortic calcification'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C3178781', 'cui_str': 'Vascular Stiffness'}, {'cui': 'C0342649', 'cui_str': 'Vascular calcification'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",159.0,0.783004,"CONCLUSIONS


Vitamin K2 supplementation did not improve vascular stiffness or other measures of vascular health in this trial involving individuals with CKD.
","[{'ForeName': 'Miles D', 'Initials': 'MD', 'LastName': 'Witham', 'Affiliation': 'AGE Research Group, National Institute for Health Research Newcastle Biomedical Research Centre, Translational and Clinical Research Institute, Newcastle University and Newcastle-upon-Tyne National Health Service Trust, Tyne, United Kingdom Miles.Witham@newcastle.ac.uk.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Lees', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Myra', 'Initials': 'M', 'LastName': 'White', 'Affiliation': 'School of Medicine, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Band', 'Affiliation': 'Tayside Clinical Trials Unit, Ninewells Hospital, Dundee, United Kingdom.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Bell', 'Affiliation': 'School of Medicine, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Donna J', 'Initials': 'DJ', 'LastName': 'Chantler', 'Affiliation': 'Department of Clinical Biochemistry, National Health Service Greater Glasgow and Clyde, Glasgow Royal Infirmary, Glasgow, United Kingdom.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Ford', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Roberta L', 'Initials': 'RL', 'LastName': 'Fulton', 'Affiliation': 'School of Nursing and Health Sciences, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Kennedy', 'Affiliation': 'School of Medicine, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Roberta C', 'Initials': 'RC', 'LastName': 'Littleford', 'Affiliation': 'University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ian V', 'Initials': 'IV', 'LastName': 'McCrea', 'Affiliation': 'Department of Radiology, National Health Service Greater Glasgow and Clyde, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'McGlynn', 'Affiliation': 'Clinical Research Facility, National Health Service Greater Glasgow and Clyde, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Panarelli', 'Affiliation': 'Department of Clinical Biochemistry, National Health Service Greater Glasgow and Clyde, Glasgow Royal Infirmary, Glasgow, United Kingdom.'}, {'ForeName': 'Maximilian R', 'Initials': 'MR', 'LastName': 'Ralston', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Rutherford', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Severn', 'Affiliation': 'Renal Unit, National Health Service Tayside, Ninewells Hospital, Dundee, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Thomson', 'Affiliation': 'Clinical Research Facility, National Health Service Greater Glasgow and Clyde, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Jamie P', 'Initials': 'JP', 'LastName': 'Traynor', 'Affiliation': 'Clinical Research Facility, National Health Service Greater Glasgow and Clyde, Queen Elizabeth University Hospital, Glasgow, United Kingdom.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Struthers', 'Affiliation': 'School of Medicine, University of Dundee, Dundee, United Kingdom.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Wetherall', 'Affiliation': 'Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Patrick B', 'Initials': 'PB', 'LastName': 'Mark', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2020020225']
2915,32817358,"Efficacy and safety of adjunctive lacosamide in the treatment of primary generalised tonic-clonic seizures: a double-blind, randomised, placebo-controlled trial.","OBJECTIVE


To evaluate efficacy and safety of lacosamide (up to 12 mg/kg/day or 400 mg/day) as adjunctive treatment for uncontrolled primary generalised tonic-clonic seizures (PGTCS) in patients (≥4 years) with idiopathic generalised epilepsy (IGE).
METHODS


Phase 3, double-blind, randomised, placebo-controlled trial (SP0982; NCT02408523) in patients with IGE and PGTCS taking 1-3 concomitant antiepileptic drugs. Primary outcome was time to second PGTCS during 24-week treatment.
RESULTS


242 patients were randomised and received ≥1 dose of trial medication (lacosamide/placebo: n=121/n=121). Patients (mean age: 27.7 years; 58.7% female) had a history of generalised-onset seizures (tonic-clonic 99.6%; myoclonic 38.8%; absence 37.2%). Median treatment duration with lacosamide/placebo was 143/65 days. Risk of developing a second PGTCS during 24-week treatment was significantly lower with lacosamide than placebo (Kaplan-Meier survival estimates 55.27%/33.37%; HR 0.540, 95% CI 0.377 to 0.774; p<0.001; n=118/n=121). Median time to second PGTCS could not be estimated for lacosamide (>50% of patients did not experience a second PGTCS) and was 77.0 days for placebo. Kaplan-Meier estimated freedom from PGTCS at end of the 24-week treatment period (day 166) for lacosamide/placebo was 31.3%/17.2% (difference 14.1%; p=0.011). More patients on lacosamide than placebo had ≥50% (68.1%/46.3%) or ≥75% (57.1%/36.4%) reduction from baseline in PGTCS frequency/28 days, or observed freedom from PGTCS during treatment (27.5%/13.2%) (n=119/n=121). 96/121 (79.3%) patients on lacosamide had treatment-emergent adverse events (placebo 79/121 (65.3%)), most commonly dizziness (23.1%), somnolence (16.5%), headache (14.0%). No patients died during the trial.
CONCLUSIONS


Lacosamide was efficacious and generally safe as adjunctive treatment for uncontrolled PGTCS in patients with IGE.",2020,"Risk of developing a second PGTCS during 24-week treatment was significantly lower with lacosamide than placebo (Kaplan-Meier survival estimates 55.27%/33.37%; HR 0.540, 95% CI 0.377 to 0.774; p<0.001; n=118/n=121).","['primary generalised tonic-clonic seizures', 'uncontrolled primary generalised tonic-clonic seizures (PGTCS) in patients (≥4 years) with idiopathic generalised epilepsy (IGE', 'patients with IGE', 'patients with IGE and PGTCS taking 1-3 concomitant antiepileptic drugs', '242 patients', 'Patients (mean age: 27.7 years; 58.7% female) had a history of generalised-onset seizures (tonic-clonic 99.6%; myoclonic 38.8%; absence 37.2']","['trial medication (lacosamide/placebo', 'lacosamide', 'lacosamide/placebo', 'adjunctive lacosamide', 'placebo']","['headache', 'dizziness', 'treatment-emergent adverse events', 'time to second PGTCS', 'Efficacy and safety', 'Median time to second PGTCS', 'somnolence']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270850', 'cui_str': 'Idiopathic generalized epilepsy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C3543842', 'cui_str': 'TONICS'}, {'cui': 'C0332197', 'cui_str': 'Absent'}]","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0893761', 'cui_str': 'lacosamide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}]",242.0,0.731704,"Risk of developing a second PGTCS during 24-week treatment was significantly lower with lacosamide than placebo (Kaplan-Meier survival estimates 55.27%/33.37%; HR 0.540, 95% CI 0.377 to 0.774; p<0.001; n=118/n=121).","[{'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Vossler', 'Affiliation': 'Department of Neurology, University of Washington, Seattle, Washington, USA david_vossler@valleymed.org.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Knake', 'Affiliation': 'Department of Neurology, Epilepsy Centre Hessen, Philipps-University Marburg, Marburg, Germany.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': ""O'Brien"", 'Affiliation': 'Department of Neurosciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Shinjuku Neuro Clinic, Tokyo, Japan.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Brock', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Steiniger-Brach', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Williams', 'Affiliation': 'UCB Pharma, Raleigh, North Carolina, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Roebling', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2020-323524']
2916,32817407,"Bilateral ultrasound-guided thoracic erector spinae plane blocks using a programmed intermittent bolus improve opioid-sparing postoperative analgesia in pediatric patients after open cardiac surgery: a randomized, double-blind, placebo-controlled trial.","BACKGROUND


Postoperative pain after pediatric cardiac surgery is usually treated with intravenous opioids. Recently, the focus has been on postoperative regional analgesia with the introduction of ultrasound-guided erector spinae plane blocks (ESPBs). We hypothesized that bilateral ESPB with a programmed intermittent bolus (PIB) regimen decreases postoperative morphine consumption at 48 hours and improves analgesia in children who undergo cardiac surgery.
METHODS


This randomized, double-blind, placebo-controlled study comprised 50 children who underwent cardiac surgery through midline sternotomy. The patients were allocated randomly into two groups: ultrasound-guided bilateral ESPB at the level of T3-T4 transverse process then PIB with saline infusion (group 1, n=23) or PIB with 0.2% ropivacaine (group 2, n=27). Intravenous morphine at 30 µg/kg/hour was used as rescue analgesia. Postoperative pain was assessed using the COMFORT-B score for extubation, drain removal, and mobilization, and the FLACC (Face, Legs, Activity, Cry, Consolability) scale at 0, 2, 4, 6, 8, 12, 16, 20, 24, 36, and 48 hours after surgery. Adverse events were noted.
RESULTS


The total dose of morphine in 48 hours was significantly decreased in patients receiving a bilateral ESPB with ropivacaine (120±320 µg/kg) compared with patients with saline infusion (512±560 µg/kg; p=0.03). Fourteen per cent of patients required rescue analgesia with morphine in group 2 compared with 41% in group 1 (p=0.05). The patients in group 2 demonstrated significantly reduced COMFORT-B scores at extubation, drain removal, and mobilization compared with those in group 1 and had reduced FLACC scale levels at 20 and 24 hours postoperatively (p=0.05 and p=0.001, respectively). No differences were reported for extubation and drain removal times or for length of hospital stay. In addition, vomiting episodes were decreased in group 2 (p=0.01).
CONCLUSIONS


In pediatric cardiac surgery, the results of this study confirm our hypothesis that bilateral ESPB analgesia with ropivacaine decreases the postoperative morphine consumption at 48 hours and demonstrates better postoperative analgesia compared with a control group. Trial registration number  NCT03593642.",2020,The total dose of morphine in 48 hours was significantly decreased in patients receiving a bilateral ESPB with ropivacaine (120±320 µg/kg) compared with patients with saline infusion (512±560 µg/kg; p=0.03).,"['pediatric patients after open cardiac surgery', '50 children who underwent cardiac surgery through midline sternotomy', 'children who undergo cardiac surgery']","['opioid-sparing postoperative analgesia', 'Intravenous morphine', 'morphine', 'ropivacaine', 'PIB with 0.2% ropivacaine', 'ultrasound-guided bilateral ESPB at the level of T3-T4 transverse process then PIB with saline infusion', 'intravenous opioids', 'Bilateral ultrasound-guided thoracic erector spinae plane blocks', 'placebo']","['vomiting episodes', 'extubation and drain removal times or for length of hospital stay', 'Adverse events', 'rescue analgesia', 'reduced COMFORT-B scores at extubation, drain removal, and mobilization', 'COMFORT-B score for extubation, drain removal, and mobilization, and the FLACC (Face, Legs, Activity, Cry, Consolability) scale', 'postoperative morphine consumption', 'FLACC scale levels', 'postoperative analgesia', 'Postoperative pain']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1301695', 'cui_str': 'Intermittent bolus'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0411815', 'cui_str': 'Removal of drain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}]",50.0,0.598763,The total dose of morphine in 48 hours was significantly decreased in patients receiving a bilateral ESPB with ropivacaine (120±320 µg/kg) compared with patients with saline infusion (512±560 µg/kg; p=0.03).,"[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Macaire', 'Affiliation': 'Anesthesia and Pain Department, Vinmec International Hospital, Hanoi, Viet Nam.'}, {'ForeName': 'Nga', 'Initials': 'N', 'LastName': 'Ho', 'Affiliation': 'Department of Cardiac Surgery, Vinmec Central Park International Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Vien', 'Initials': 'V', 'LastName': 'Nguyen', 'Affiliation': 'Department of Cardiac Surgery, Vinmec Central Park International Hospital, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Hieu', 'Initials': 'H', 'LastName': 'Phan Van', 'Affiliation': 'Department of Pharmacology, Forensic Medicine Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dinh Nguyen Thien', 'Affiliation': 'Department of Pharmacology, Forensic Medicine Center, Ho Chi Minh City, Viet Nam.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Bringuier', 'Affiliation': 'Department of Biostatistics, Hopital Lapeyronie, Montpellier, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Capdevila', 'Affiliation': 'Anesthesiology and Critical Care Department and Neurosciences Institute, Inserm U1051, Hopital Lapeyronie, Montpellier, France x-capdevila@chu-montpellier.fr.'}]",Regional anesthesia and pain medicine,['10.1136/rapm-2020-101496']
2917,32817444,The Effect of High Protein and Mobility-Based Rehabilitation on Clinical Outcomes in Survivors of Critical Illness.,"BACKGROUND


Protein supplementation and mobility-based rehabilitation programs (MRP) individually improve functional outcomes in survivors of critical illness. We hypothesized that combining MRP therapy with high protein supplementation is associated with greater weaning success from prolonged mechanical ventilation (PMV) and increased discharge home in this population.
METHODS


We conducted a retrospective analysis assessing the effects of an MRP on a cohort of survivors of critical illness. All received usual care (UC) rehabilitation. The MRP group received 3 additional MRP sessions each week for a maximum of 8 weeks. Subjects were prescribed nutrition and classified as receiving high protein (HPRO) or low protein (LPRO), based on a recommended 1.0 g/kg/d, and then the subjects were categorized into 4 groups: MRP+HPRO, MRP+LPRO, UC+HPRO, and UC+LPRO.
RESULTS


A total of 32 subjects were enrolled. The MRP+HPRO group had greater weaning success (90% vs 38%,  P  = .045) and a higher rate of discharge home (70% vs 13%,  P  = .037) compared to UC+LPRO group. The MRP+HPRO group had a higher, nonsignificant rate of discharge home compared to the MRP+LPRO (70% vs 20%,  P  = .10).
CONCLUSIONS


Combining high protein with mobility-based rehabilitation was associated with increased rates of discharge home and ventilator weaning success in survivors of critical illness. Further studies are needed to evaluate the role of combined exercise and nutrition interventions in this population.",2020,"The MRP+HPRO group had greater weaning success (90% vs 38%,  P  = .045) and a higher rate of discharge home (70% vs 13%,  P  = .037) compared to UC+LPRO group.","['32 subjects were enrolled', 'survivors of critical illness', 'Survivors of Critical Illness']","['nutrition and classified as receiving high protein (HPRO) or low protein (LPRO', 'MRP+HPRO', 'MRP', 'MRP+LPRO', 'Protein supplementation and mobility-based rehabilitation programs (MRP', 'High Protein and Mobility-Based Rehabilitation', 'MRP therapy with high protein supplementation', 'usual care (UC) rehabilitation']","['weaning success', 'rate of discharge home', 'nonsignificant rate of discharge home']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0242972', 'cui_str': 'Low protein diet'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0770246', 'cui_str': 'Protein supplementation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",32.0,0.0547322,"The MRP+HPRO group had greater weaning success (90% vs 38%,  P  = .045) and a higher rate of discharge home (70% vs 13%,  P  = .037) compared to UC+LPRO group.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Wappel', 'Affiliation': 'Department of Pulmonary, Critical Care and Sleep Medicine, Greater Baltimore Medical Center, Towson, Maryland.'}, {'ForeName': 'Dena H', 'Initials': 'DH', 'LastName': 'Tran', 'Affiliation': 'Department of Medicine, University of Maryland Medical Center Midtown Campus, Baltimore, Maryland.'}, {'ForeName': 'Chris L', 'Initials': 'CL', 'LastName': 'Wells', 'Affiliation': 'Department of Physical Therapy, University of Maryland Medical Center, Baltimore, Maryland.'}, {'ForeName': 'Avelino C', 'Initials': 'AC', 'LastName': 'Verceles', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Maryland School of Medicine, Baltimore, Maryland. avercele@som.umaryland.edu.'}]",Respiratory care,['10.4187/respcare.07840']
2918,32816533,Behavioral aspects of executive functions in young adults with well-controlled epilepsy.,"Executive function (EF) skills involve higher-level cognitive functions, such as planning, goal formation, goal-directed behavior, and effective performance. Previous research has shown that these aspects of EF are essential for successful functioning in everyday life. This study aimed to examine differences in the behavioral aspects of EF between young adults with epilepsy and healthy controls. The study involved 62 young adults, aged 18 to 30 years, divided into two groups: a study group of young adults with well-controlled epilepsy and a control group of healthy young adults. The groups were matched according to basic sociodemographic characteristics. The Behavior Rating Inventory of Executive Function - Adult version was used to assess the behavioral aspects of executive functions. A significant difference between groups was only observed on the Organization of Materials scale, where the group with epilepsy achieved better performance. Our findings suggest that self-assessed behavioral control of EF is almost the same in healthy young adults and young adults with epilepsy who have no comorbidities and have good control of the disease as well as preserved intellectual ability and functionality in everyday activities.",2020,"A significant difference between groups was only observed on the Organization of Materials scale, where the group with epilepsy achieved better performance.","['healthy young adults and young adults with epilepsy', '62 young adults, aged 18 to 30\xa0years, divided into two groups: a study group of young adults with well-controlled epilepsy and a control group of healthy young adults', 'young adults with well-controlled epilepsy', 'young adults with epilepsy and healthy controls']",[],"['executive functions', 'Executive function (EF) skills involve higher-level cognitive functions, such as planning, goal formation, goal-directed behavior, and effective performance', 'Organization of Materials scale', 'Behavior Rating Inventory of Executive Function - Adult version']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2607870', 'cui_str': 'Version'}]",62.0,0.0206743,"A significant difference between groups was only observed on the Organization of Materials scale, where the group with epilepsy achieved better performance.","[{'ForeName': 'Vojislava', 'Initials': 'V', 'LastName': 'Bugarski Ignjatović', 'Affiliation': 'Faculty of Medicine, Department of Psychology, University of Novi Sad , Novi Sad, Serbia.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Pavić', 'Affiliation': 'Faculty of Medicine, Department of Special Education and Rehabilitation, University of Novi Sad , Novi Sad, Serbia.'}, {'ForeName': 'Ksenija', 'Initials': 'K', 'LastName': 'Gebauer Bukurov', 'Affiliation': 'Faculty of Medicine, Department of Neurology, University of Novi Sad , Novi Sad, Serbia.'}, {'ForeName': 'Željka', 'Initials': 'Ž', 'LastName': 'Nikolašević', 'Affiliation': 'Faculty of Medicine, Department of Psychology, University of Novi Sad , Novi Sad, Serbia.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Krstić', 'Affiliation': 'Faculty of Medicine, Department of Psychology, University of Novi Sad , Novi Sad, Serbia.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Stojadinović', 'Affiliation': 'Faculty of Medicine, Department of Pediatrics, University of Novi Sad , Novi Sad, Serbia.'}]","Psychology, health & medicine",['10.1080/13548506.2020.1810719']
2919,32816561,Stent evaluation by coronary computed tomography angiography: a comparison between Iopamidol-370 and Ioversol-320 hypo-osmolar iodine concentration contrasts.,"OBJECTIVE


Qualitative and quantitative image analysis between Iopamidol-370 and Ioversol-320 in stents´ evaluation by coronary computed tomography angiography (CTA).
METHODS


Sixty-five patients with low-risk stable angina undergoing stent follow-up with coronary CTA were assigned to Iopamidol I-370 ( n  = 33) or Ioversol I-320 ( n  = 32) in this prospective, double-blind, non-inferiority, randomized trial. Stent lumen image quality was graded by 5-point Likert Scale. Lumen mean attenuation was measured at native coronary segments: pre-stent, post-stent, distal segments and at coronary plaques. Lumen attenuation increase (LAI) ratio was calculated for all stents. Heart rate (HR) variation, premature heart beats (PHB), heat sensation (HS), blooming and beam hardening were also assessed.
RESULTS


Image quality was similar between groups, with no significant difference (Likert score 4.48 ± 0.75  vs  4.54 ± 0.65,  p  = 0.5). There were similarities in LAI ratio between I-370 and I-320 (0.39 ± 0.42  vs  0.48 ± 0.44 HU,  p  = 0.08). Regarding lumen mean attenuation at native coronary segments, a significant difference was observed, with I-320 presenting lower values, including contrast mean attenuation in distal segments. After statistical multivariate analysis, three variables correlated with stent image quality: 1) stent diameter, 2) HR variation and 3) stent lumen LAI ratio.
CONCLUSIONS


There was no significant difference between Iopamidol-370 mgI ml -1  and Ioversol-320 mgI ml -1  contrasts regarding overall stent lumen image quality, which was mainly influenced by stent diameter, HR and LAI ratio. Advances in knowledge: Coronary CTA allows adequate stents' visualization and image quality is influenced by stent diameter, HR variation and LAI ratio.Stents' image quality showed no difference between different concentration contrasts (I-370 vs. I-320); however, higher concentration contrasts may provide an improved overall visualization, especially regarding coronary distal segments.",2020,"There was no significant difference between Iopamidol-370 mgI ml -1  and Ioversol-320 mgI ml -1  contrasts regarding overall stent lumen image quality, which was mainly influenced by stent diameter, HR and LAI ratio.","['knowledge', 'Sixty-five patients with low-risk stable angina undergoing stent follow-up with coronary CTA were assigned to']","['coronary computed tomography angiography', 'coronary computed tomography angiography (CTA', 'Iopamidol I-370 ( n  = 33) or Ioversol I-320']","['Lumen mean attenuation', 'Stent lumen image quality', 'stent image quality: 1) stent diameter, 2) HR variation and 3) stent lumen LAI ratio', 'Image quality', 'Lumen attenuation increase (LAI) ratio', 'Heart rate (HR) variation, premature heart beats (PHB), heat sensation (HS), blooming and beam hardening', 'LAI ratio']","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0022026', 'cui_str': 'Iopamidol'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0063828', 'cui_str': 'ioversol'}, {'cui': 'C4517711', 'cui_str': '320'}]","[{'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0443021', 'cui_str': 'Lai'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0234193', 'cui_str': 'Ability to sense heat'}]",65.0,0.112651,"There was no significant difference between Iopamidol-370 mgI ml -1  and Ioversol-320 mgI ml -1  contrasts regarding overall stent lumen image quality, which was mainly influenced by stent diameter, HR and LAI ratio.","[{'ForeName': 'Annelisa Moura', 'Initials': 'AM', 'LastName': 'Garcia', 'Affiliation': 'Sirio-Libanes Hospital, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Antonildes N', 'Initials': 'AN', 'LastName': 'Assunção-Jr', 'Affiliation': 'Sirio-Libanes Hospital, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Roberto Nery', 'Initials': 'RN', 'LastName': 'Dantas-Jr', 'Affiliation': 'Sirio-Libanes Hospital, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Jose Rodrigues', 'Initials': 'JR', 'LastName': 'Parga', 'Affiliation': 'Sirio-Libanes Hospital, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ganem', 'Affiliation': 'Sirio-Libanes Hospital, Sao Paulo, SP, Brazil.'}]",The British journal of radiology,['10.1259/bjr.20200078']
2920,32816564,Impact of Therapist Training on Parent Attendance in Mental Health Services for Children with ASD.,"OBJECTIVE


The current study explored the impact of training therapists in a mental health intervention for children with autism spectrum disorder (ASD) on parent attendance in their children's therapy sessions. We also examined family, therapist, and program factors as potential moderators.
METHOD


Data were drawn from a cluster-randomized community effectiveness trial of ""An Individualized Mental Health Intervention for ASD (AIM HI)"". Participants included 168 therapists yoked with 189 children recruited from publicly-funded mental health services. Data included family (caregiver strain, parent sense of competence, race/ethnicity), therapist (background, experience), and program (service setting) characteristics, and parent session attendance. Multilevel models were used to evaluate the effectiveness of AIM HI therapist training on caregiver attendance and identify moderators of training effects on parent attendance.
RESULTS


Parents attended a higher percentage of sessions in the AIM HI training condition compared to the Usual Care condition. Program service setting moderated the effect of AIM HI training, with higher parent attendance in non-school (mostly outpatient) settings compared to school settings and a significantly smaller difference between the settings in the AIM HI condition.
CONCLUSIONS


Effective strategies to promote parent engagement, especially in service settings such as schools, are warranted. Findings support the effectiveness of AIM HI training in promoting parent attendance across multiple publicly-funded mental health service settings. The larger effect in school-based programs supports the utility of training in evidence-based interventions such as AIM HI to increase the feasibility of parent attendance in such services.",2020,"Multilevel models were used to evaluate the effectiveness of AIM HI therapist training on caregiver attendance and identify moderators of training effects on parent attendance.
","['Participants included 168 therapists yoked with 189 children recruited from publicly-funded mental health services', 'Children with ASD', 'children with autism spectrum disorder (ASD']","['HI therapist training', 'An Individualized Mental Health Intervention', 'mental health intervention', 'HI training', 'Therapist Training', 'training therapists']","['family (caregiver strain, parent sense of competence, race/ethnicity), therapist (background, experience), and program (service setting) characteristics, and parent session attendance']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}]",189.0,0.0541864,"Multilevel models were used to evaluate the effectiveness of AIM HI therapist training on caregiver attendance and identify moderators of training effects on parent attendance.
","[{'ForeName': 'Kelsey S', 'Initials': 'KS', 'LastName': 'Dickson', 'Affiliation': 'Department of Child and Family Development, San Diego State University.'}, {'ForeName': 'Colby', 'Initials': 'C', 'LastName': 'Chlebowski', 'Affiliation': 'Child and Adolescent Services Research Center.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Haine-Schlagel', 'Affiliation': 'Department of Child and Family Development, San Diego State University.'}, {'ForeName': 'Bill', 'Initials': 'B', 'LastName': 'Ganger', 'Affiliation': 'Child and Adolescent Services Research Center.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Brookman-Frazee', 'Affiliation': 'Child and Adolescent Services Research Center.'}]","Journal of clinical child and adolescent psychology : the official journal for the Society of Clinical Child and Adolescent Psychology, American Psychological Association, Division 53",['10.1080/15374416.2020.1796682']
2921,32816578,L-Carnitine supplementation reduces biomarkers of inflammatory and oxidative stress in patients with coronary artery disease: a randomised controlled trial.,"OBJECTIVE


l-Carnitine has been suggested as a potential nutrient that alleviates the oxidative and inflammatory damages of coronary artery disease (CAD), but the results of the previous studies of the importance of this supplementation remains unclear. This study attempts to evaluate the effects of l-carnitine (LC) supplementation on oxidative stress and inflammatory biomarkers in patients with CAD.
METHODS


A double-blind, randomised, placebo-trial was conducted on 75 CAD subjects. Patients were randomly assigned to receive LC (1000 mg/day) or placebo capsules over 3 months. Sera high-sensitivity C-reactive protein (hs-CRP), myeloperoxidase (MPO), nitrotyrosine (NT) and total antioxidant capacity (TAC) were assayed.
RESULTS


A significant increase in serum TAC and a significant decrease in MPO, NT, and hs-CRP levels were detected following 12 weeks of LC supplementation, compared to the placebo.
CONCLUSIONS


These results suggest that LC supplementation may exert beneficial effect on cardiovascular health through attenuate oxidative and inflammatory markers in CAD patients.",2020,"A significant increase in serum TAC and a significant decrease in MPO, NT, and hs-CRP levels were detected following 12 weeks of LC supplementation, compared to the placebo.
","['75 CAD subjects', 'patients with CAD', 'patients with coronary artery disease', 'CAD patients']","['LC supplementation', 'L-Carnitine supplementation', 'l-carnitine (LC) supplementation', 'LC', 'placebo']","['inflammatory and oxidative stress', 'oxidative stress and inflammatory biomarkers', 'serum TAC', 'MPO, NT, and hs-CRP levels', 'Sera high-sensitivity C-reactive protein (hs-CRP), myeloperoxidase (MPO), nitrotyrosine (NT) and total antioxidant capacity (TAC']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0047645', 'cui_str': '3-nitrotyrosine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",75.0,0.581321,"A significant increase in serum TAC and a significant decrease in MPO, NT, and hs-CRP levels were detected following 12 weeks of LC supplementation, compared to the placebo.
","[{'ForeName': 'Seyed Mostafa', 'Initials': 'SM', 'LastName': 'Nachvak', 'Affiliation': 'Nutritional Sciences Department, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shabanpur', 'Affiliation': 'Student Research Committee, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Roghayeh', 'Initials': 'R', 'LastName': 'Mostafai', 'Affiliation': 'Nutritional Sciences Department, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Heidari Moghaddam', 'Affiliation': 'Department of Cardiology, Faculty of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Moludi', 'Affiliation': 'Nutritional Sciences Department, School of Nutritional Sciences and Food Technology, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Archives of physiology and biochemistry,['10.1080/13813455.2020.1797102']
2922,32816741,Primary care doctors' views on self-monitoring of blood pressure and self-titration among patients with uncontrolled hypertension in Spain. The ADAMPA trial focus group study.,"BACKGROUND


Despite the increased use of blood pressure (BP) monitoring devices at home, the hypertension of more than 50% of European patients remains uncontrolled. Nevertheless, the self-management of BP, through the combination of home monitoring of BP with self-titration, could be anaccessible and effective tool for improving hypertension control in the primary care setting. The ADAMPA study is a trial with participants randomised to BP self-management (BPSM) with self-titration of antihypertensive medication or to usual care, in a population of patients with poorly controlled hypertension.
AIM


To explore the views and attitudes of primary care doctors participating in the ADAMPA trial regarding BPSM with self-titration.
DESIGN & SETTING


A focus group study took place with primary care doctors participating in the ADAMPA trial, which was carried out in one health district of the Valencia Health System in Spain.
METHOD


Nine primary care doctors participating in the ADAMPA trial were included in the focus group. Three researchers (two using manual methods and one using NVivo software) independently conducted a content analysis, reading the transcripts, identifying, classifying, and coding the contents, and developing a conceptual scheme based on these topics.
RESULTS


Participating doctors clearly support home BP monitoring (HBPM), the setting of individual BP targets, and incorporating patient readings into decision-making. They consider it an investment to educate patients for medication self-adjustment and estimate that an important proportion of their patients are potential candidates for hypertension self-management with medication self-titration. However, they show important divergences regarding the role of nursing in BP control.
CONCLUSION


Primary care doctors participating in the ADAMPA trial feel comfortable with BPSM with self-titration, and would consider extending its use (or the use of some components, such as BP target setting) to other patients with hypertension outside the trial.",2020,"The ADAMPA study is a trial with participants randomised to BP self-management (BPSM) with self-titration of antihypertensive medication or to usual care, in a population of patients with poorly controlled hypertension.
","['Nine primary care doctors participating in the ADAMPA trial were included in the focus group', 'patients with uncontrolled hypertension in Spain', 'primary care doctors participating in the ADAMPA trial regarding BPSM with self-titration', 'patients with poorly controlled hypertension', 'A focus group study took place with primary care doctors participating in the ADAMPA trial, which was carried out in one health district of the Valencia Health System in Spain']",['BP self-management (BPSM) with self-titration of antihypertensive medication or to usual care'],"['blood pressure (BP) monitoring devices', 'home BP monitoring (HBPM']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C4505266', 'cui_str': 'One Health Concept'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0003364', 'cui_str': 'Hypotensive agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0026426', 'cui_str': 'Blood pressure monitoring'}]",,0.0296267,"The ADAMPA study is a trial with participants randomised to BP self-management (BPSM) with self-titration of antihypertensive medication or to usual care, in a population of patients with poorly controlled hypertension.
","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Marco-Moreno', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Martínez-Ibañez', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Avelino-Hidalgo', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bellot-Pujalte', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Barreira-Franch', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Martínez-Ibañez', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Escrig-Veses', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Giménez-Loreiro', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Bóveda-García', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Calleja-Del-Ser', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Hurtado', 'Affiliation': 'Health Services Research Unit, FISABIO, València, Spain.'}, {'ForeName': 'Aníbal', 'Initials': 'A', 'LastName': 'García-Sempere', 'Affiliation': 'Health Services Research Unit, FISABIO, València, Spain.'}, {'ForeName': 'Clara L', 'Initials': 'CL', 'LastName': 'Rodríguez-Bernal', 'Affiliation': 'Health Services Research Unit, FISABIO, València, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Peiró', 'Affiliation': 'Health Services Research Unit, FISABIO, València, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Sanfélix-Genovés', 'Affiliation': 'Instituto de Investigación Sanitaria INCLIVA, València, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Sanfelix-Gimeno', 'Affiliation': 'Health Services Research Unit, FISABIO, València, Spain sanfelix_gab@gva.es.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJGP open,['10.3399/bjgpopen20X101062']
2923,32816784,"Correction:  Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48-week phase llb, randomised, double blind, placebo-controlled, dose-ranging study .",,2020,,['patients with active ankylosing spondylitis'],"['interleukin-17A and interleukin-17F with bimekizumab', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038013', 'cui_str': 'Ankylosing spondylitis'}]","[{'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C1432339', 'cui_str': 'IL17F protein, human'}, {'cui': 'C4519734', 'cui_str': 'bimekizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.573912,,[],Annals of the rheumatic diseases,['10.1136/annrheumdis-2020-216980corr1']
2924,32816787,Optimising outcomes of exercise and corticosteroid injection in patients with subacromial pain (impingement) syndrome: a factorial randomised trial.,"OBJECTIVES


To compare the clinical effectiveness of (1) physiotherapist-led exercise versus an exercise leaflet, and (2) ultrasound-guided subacromial corticosteroid injection versus unguided injection for pain and function in subacromial pain (formerly impingement) syndrome (SAPS).
METHODS


This was a single-blind 2×2 factorial randomised trial. Adults with SAPS were randomised equally to one of four treatment groups: (1) ultrasound-guided corticosteroid injection and physiotherapist-led exercise, (2) ultrasound-guided corticosteroid injection and an exercise leaflet, (3) unguided corticosteroid injection and physiotherapist-led exercise and (4) unguided corticosteroid injection and an exercise leaflet. The primary outcome was the Shoulder Pain and Disability Index (SPADI), collected at 6 weeks, 6 and 12 months and compared at 6 weeks for the injection interventions and 6 months for the exercise interventions by intention to treat.
RESULTS


We recruited 256 participants (64 treatment per group). Response rates for the primary outcome were 94% at 6 weeks, 88% at 6 months and 80% at 12 months. Greater improvement in total SPADI score was seen with physiotherapist-led exercise than with the exercise leaflet at 6 months (adjusted mean difference -8.23; 95% CI -14.14 to -2.32). There were no significant differences between the injection groups at 6 weeks (-2.04; -7.29 to 3.22), 6 months (-2.36; -8.16 to 3.44) or 12 months (1.59; -5.54 to 8.72).
CONCLUSIONS


In patients with SAPS, physiotherapist-led exercise leads to greater improvements in pain and function than an exercise leaflet. Ultrasound guidance confers no additional benefit over unguided corticosteroid injection.
TRIAL REGISTRATION NUMBER


ISRCTN42399123.",2020,"In patients with SAPS, physiotherapist-led exercise leads to greater improvements in pain and function than an exercise leaflet.","['subacromial pain (formerly impingement) syndrome (SAPS', 'Adults with SAPS', 'patients with subacromial pain (impingement) syndrome', '256 participants (64 treatment per group']","['ultrasound-guided corticosteroid injection and physiotherapist-led exercise, (2) ultrasound-guided corticosteroid injection and an exercise leaflet, (3) unguided corticosteroid injection and physiotherapist-led exercise and (4) unguided corticosteroid injection and an exercise leaflet', 'exercise and corticosteroid injection', 'physiotherapist-led exercise versus an exercise leaflet, and (2) ultrasound-guided subacromial corticosteroid injection versus unguided injection']","['Response rates', 'pain and function', 'total SPADI score', 'Shoulder Pain and Disability Index (SPADI']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4728045', 'cui_str': 'Subacromial pain syndrome'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",256.0,0.338073,"In patients with SAPS, physiotherapist-led exercise leads to greater improvements in pain and function than an exercise leaflet.","[{'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Roddy', 'Affiliation': 'Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK e.roddy@keele.ac.uk.'}, {'ForeName': 'Reuben O', 'Initials': 'RO', 'LastName': 'Ogollah', 'Affiliation': 'Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Oppong', 'Affiliation': 'Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Irena', 'Initials': 'I', 'LastName': 'Zwierska', 'Affiliation': 'Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Praveen', 'Initials': 'P', 'LastName': 'Datta', 'Affiliation': 'Radiology, University Hospitals of North Midlands NHS Trust, Stoke-on-Trent, Staffordshire, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': 'Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Hay', 'Affiliation': 'Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jackson', 'Affiliation': 'Bradwell Hospital, Midlands Partnership NHS Foundation Trust, Stoke-on-Trent, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Shufflebotham', 'Affiliation': 'Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Stevenson', 'Affiliation': 'Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Danielle A', 'Initials': 'DA', 'LastName': 'van der Windt', 'Affiliation': 'Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Young', 'Affiliation': 'Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, Keele University, Keele, Staffordshire, UK.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101268']
2925,32816829,Adherence to early pulmonary rehabilitation after COPD exacerbation and risk of hospital readmission: a secondary analysis of the COPD-EXA-REHAB study.,"BACKGROUND


Early pulmonary rehabilitation after exacerbation of chronic obstructive pulmonary disease (COPD) has previously been shown to reduce the risk of hospital admission and improve physical performance and quality of life. However, the impact of attendance at early rehabilitation programmes has not been established.
OBJECTIVES


To evaluate the impact of increasing attendance to pulmonary rehabilitation on the risk of hospital admission, physical performance and quality of life in patients attending an early rehabilitation programme after an exacerbation of COPD.
METHODS


This study was a secondary exploratory analysis of the randomised controlled trial COPD-EXA-REHAB study, involving patients hospitalised with an exacerbation of COPD. The COPD-EXA-REHAB study compared early pulmonary rehabilitation, starting within 2 weeks after an exacerbation, with standard treatment, that is, the same programme starting 2 months later. The present analysis included only the 70 patients allocated to early pulmonary rehabilitation.
RESULTS


At 1-year follow-up, we found an association between the number of sessions attended and a reduction in hospital admissions (incidence rate ratio 0.93 (95% CI 0.88 to 0.99), p=0.02), corresponding to a 7% reduction for each session attended. Similarly, at 2-month follow-up, physical performance was positively associated with sessions attended: the mean Incremental Shuttle Walk Test result improved by 8 m with each session (95% CI 2.54 to 13.56, p=0.005) and the Endurance Shuttle Walk Test result by 44 s (95% CI 18.41 to 68.95, p=0.001). Quality of life, assessed using the COPD Assessment Test, was not significantly associated with the number of attended sessions, with the average score increasing by 0.15 points with each session (95% CI -0.35 to 0.65, p=0.55).
CONCLUSION


Increased attendance at early pulmonary rehabilitation after exacerbation of COPD was associated with reduced risk of hospital admission and improved physical performance.",2020,"the Endurance Shuttle Walk Test result by 44 s (95% CI 18.41 to 68.95, p=0.001).","['patients attending an early rehabilitation programme after an exacerbation of COPD', '70 patients allocated to early pulmonary rehabilitation', 'chronic obstructive pulmonary disease (COPD', 'patients hospitalised with an exacerbation of COPD']",[],"['risk of hospital admission and improved physical performance', 'risk of hospital admission, physical performance and quality of life', 'COPD exacerbation and risk of hospital readmission', 'mean Incremental Shuttle Walk Test result', 'Quality of life', 'physical performance', 'hospital admissions', 'physical performance and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",,0.177559,"the Endurance Shuttle Walk Test result by 44 s (95% CI 18.41 to 68.95, p=0.001).","[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Kjærgaard', 'Affiliation': 'Department of Internal Medicine, Respiratory Section, Herlev and Gentofte Hospital, Copenhagen University, Hellerup, Denmark jakob@naj.dk.'}, {'ForeName': 'Carsten Bogh', 'Initials': 'CB', 'LastName': 'Juhl', 'Affiliation': 'Department of Physiotherapy and Occupational Therapy, Herlev and Gentofte Hospitals, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Section of Epidemiology, Institute of Public Health, University of Copenhagen Faculty of Health and Medical Sciences, Copenhagen, Denmark.'}, {'ForeName': 'Torgny', 'Initials': 'T', 'LastName': 'Wilcke', 'Affiliation': 'Department of Internal Medicine, Respiratory Section, Herlev and Gentofte Hospital, Copenhagen University, Hellerup, Denmark.'}]",BMJ open respiratory research,['10.1136/bmjresp-2020-000582']
2926,32816874,"Efficacy and Safety Over 2 Years of Exenatide Plus Dapagliflozin in the DURATION-8 Study: A Multicenter, Double-Blind, Phase 3, Randomized Controlled Trial.","OBJECTIVE


In patients with type 2 diabetes uncontrolled with metformin, exenatide once weekly (QW) plus dapagliflozin produced greater reductions in glycemic parameters (glycated hemoglobin [HbA 1c ], fasting plasma glucose [FPG], and 2-h postprandial glucose [2-h PPG]), weight, and systolic blood pressure (SBP) than exenatide QW or dapagliflozin alone after 28 weeks of treatment in DURATION-8. Following a 24-week extension period, improvements were sustained at 52 weeks. In this study, we investigated efficacy and safety at 104 weeks after randomization.
RESEARCH DESIGN AND METHODS


DURATION-8 was a 104-week, multicenter, double-blind, randomized, active-controlled, phase 3 trial. In total, 695 adults (aged ≥18 years) with type 2 diabetes and inadequate glycemic control (HbA 1c  8.0-12.0% [64-108 mmol/mol]) despite stable metformin monotherapy (≥1,500 mg/day) were randomly assigned (1:1:1) to receive exenatide 2 mg QW plus once-daily dapagliflozin 10 mg, exenatide QW plus placebo, or dapagliflozin plus placebo. All 104-week evaluations were exploratory.
RESULTS


At week 104, 431 (62.0%) patients completed treatment. The adjusted least squares mean change (SE) from baseline to week 104 in HbA 1c  was greater with exenatide QW plus dapagliflozin (-1.70% [0.11]) versus exenatide QW plus placebo (-1.29% [0.12];  P  = 0.007) and dapagliflozin plus placebo (-1.06% [0.12];  P  < 0.001). Clinically relevant changes in FPG, 2-h PPG, weight, and SBP were also observed with exenatide QW plus dapagliflozin. There were no unexpected safety findings, and exenatide QW plus dapagliflozin was well tolerated, with no episodes of major hypoglycemia.
CONCLUSIONS


In this exploratory analysis, among those individuals who completed the trial without rescue therapy, there was clinically relevant efficacy over 2 years with exenatide QW plus dapagliflozin, with no unexpected safety findings.",2020,"There were no unexpected safety findings, and exenatide QW plus dapagliflozin was well tolerated, with no episodes of major hypoglycemia.
","['Study', 'patients with type 2 diabetes uncontrolled with', '695 adults (aged ≥18 years) with type 2 diabetes and inadequate glycemic control (HbA 1c  8.0-12.0% [64-108 mmol/mol]) despite stable metformin monotherapy (≥1,500 mg/day']","['exenatide QW plus placebo', 'metformin, exenatide once weekly (QW) plus dapagliflozin', 'dapagliflozin plus placebo', 'exenatide QW or dapagliflozin', 'exenatide QW plus dapagliflozin', 'exenatide 2 mg QW plus once-daily dapagliflozin 10 mg, exenatide QW plus placebo, or dapagliflozin plus placebo', 'Exenatide Plus Dapagliflozin']","['Efficacy and Safety', 'FPG, 2-h PPG, weight, and SBP', 'glycemic parameters (glycated hemoglobin [HbA 1c ], fasting plasma glucose [FPG], and 2-h postprandial glucose [2-h PPG]), weight, and systolic blood pressure (SBP', 'efficacy and safety']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mol'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C4026820', 'cui_str': 'exenatide 2 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",695.0,0.224679,"There were no unexpected safety findings, and exenatide QW plus dapagliflozin was well tolerated, with no episodes of major hypoglycemia.
","[{'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Jabbour', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA serge.jabbour@jefferson.edu.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frías', 'Affiliation': 'National Research Institute, Los Angeles, CA.'}, {'ForeName': 'Azazuddin', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Apex Medical Research, Chicago, IL.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hardy', 'Affiliation': 'AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Statum Research, Irvine, CA.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Guja', 'Affiliation': 'Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.'}]",Diabetes care,['10.2337/dc19-1350']
2927,32816944,Integration of antiangiogenic therapy with cisplatin and gemcitabine chemotherapy in patients with nasopharyngeal carcinoma.,"PURPOSE


Induction cisplatin and gemcitabine chemotherapy is a standard treatment for locally advanced NPC. Inhibition of VEGF axis has been shown to promote maturation of microvasculature and improve perfusion. We conducted a four-arm study to assess the effect of 2 doses of either sunitinib or bevacizumab with chemotherapy in NPC.
EXPERIMENTAL DESIGN


Patients with treatment naïve locally advanced NPC were treated with 3 cycles of 3-weekly cisplatin and gemcitabine preceded by 1 week of anti-VEGF therapy for each cycle, followed by standard concurrent chemoradiation: Arm A patients received 7 days of 12.5mg/day sunitinib; Arm B 7 days of 25mg/day sunitinib; Arm C bevacizumab 7.5mg/kg infusion; Arm D bevacizumab 2.5mg/kg infusion. Patients with metastatic NPC were treated with up to 6 cycles of similar treatment without concurrent chemoradiation.
RESULTS


Complete metabolic response (mCR) by whole body  18 fluorodeoxyglucose PET was highest in Arm C (significant difference in 4 groups Fisher's exact test p=0.001; type 1 error=0.05), with 42% mCR (95% CI 18 - 67) and 3-year relapse free survival of 88% in patients with locally advanced NPC. Significant increase in pericyte coverage signifying microvascular maturation and increased immune cell infiltration was observed in post treatment tumor biopsies in Arm C. Myelosuppression was more profound in sunitinib containing arms, and tolerability was established in Arm C where hypertension was the most significant toxicity.
CONCLUSION


Bevacizumab 7.5mg/kg with cisplatin and gemcitabine was well tolerated. Promising tumour response was observed and supported mechanistically by positive effects on tumour perfusion and immune cell trafficking into the tumour.",2020,"Significant increase in pericyte coverage signifying microvascular maturation and increased immune cell infiltration was observed in post treatment tumor biopsies in Arm C. Myelosuppression was more profound in sunitinib containing arms, and tolerability was established in Arm C where hypertension was the most significant toxicity.
","['patients with nasopharyngeal carcinoma', 'Patients with treatment naïve locally advanced NPC', 'locally advanced NPC', 'Patients with metastatic NPC']","['standard concurrent chemoradiation', 'bevacizumab 7.5mg/kg infusion; Arm D bevacizumab', 'Bevacizumab', 'sunitinib or bevacizumab with chemotherapy', 'cisplatin and gemcitabine', 'anti-VEGF therapy', 'cisplatin and gemcitabine chemotherapy']","['tolerated', 'pericyte coverage signifying microvascular maturation', 'immune cell infiltration', '3-year relapse free survival', 'Complete metabolic response (mCR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2931822', 'cui_str': 'Nasopharyngeal carcinoma'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0028587', 'cui_str': 'Nuclear Pore'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C4727874', 'cui_str': 'Anti-VEGF therapy'}]","[{'cui': 'C0598800', 'cui_str': 'Pericyte of Rouget'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.0605571,"Significant increase in pericyte coverage signifying microvascular maturation and increased immune cell infiltration was observed in post treatment tumor biopsies in Arm C. Myelosuppression was more profound in sunitinib containing arms, and tolerability was established in Arm C where hypertension was the most significant toxicity.
","[{'ForeName': 'Wan Qin', 'Initials': 'WQ', 'LastName': 'Chong', 'Affiliation': 'National University Cancer Institute.'}, {'ForeName': 'Chwee Ming', 'Initials': 'CM', 'LastName': 'Lim', 'Affiliation': 'Department of Otolaryngology- Head and Neck Surgery, National University Hospital.'}, {'ForeName': 'Arvind Kumar', 'Initials': 'AK', 'LastName': 'Sinha', 'Affiliation': 'Diagnostic Imaging, National University Hospital, Singapore.'}, {'ForeName': 'Chee Seng', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Department of Haematology-Oncology, National University Health System.'}, {'ForeName': 'Gloria Hui Jia', 'Initials': 'GHJ', 'LastName': 'Chan', 'Affiliation': 'Department of Haematology-Oncology, National University Health System.'}, {'ForeName': 'Yiqing', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Haematology-Oncology, National University Health System.'}, {'ForeName': 'Nesaretnam', 'Initials': 'N', 'LastName': 'Barr Kumarakulasinghe', 'Affiliation': 'Department of Haematology-Oncology, National University Health System.'}, {'ForeName': 'Raghav', 'Initials': 'R', 'LastName': 'Sundar', 'Affiliation': 'Haematology-Oncology, National University Health System.'}, {'ForeName': 'Anand D', 'Initials': 'AD', 'LastName': 'Jeyasekharan', 'Affiliation': 'Cancer Science Institute of Singapore, National University of Singapore.'}, {'ForeName': 'Woei Shyang', 'Initials': 'WS', 'LastName': 'Loh', 'Affiliation': 'Department of Otolaryngology- Head and Neck Surgery, National University of Singapore.'}, {'ForeName': 'Joshua K', 'Initials': 'JK', 'LastName': 'Tay', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Stanford University School of Medicine.'}, {'ForeName': 'Kritika', 'Initials': 'K', 'LastName': 'Yadav', 'Affiliation': 'Experimental therapeutics, Cancer Science Institute, Singapore.'}, {'ForeName': 'Lingzhi', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Haematology-Oncology, National University of Singapore.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Wong', 'Affiliation': 'Haematology-Oncology, National University Health System.'}, {'ForeName': 'Li Ren', 'Initials': 'LR', 'LastName': 'Kong', 'Affiliation': 'Experimental Therapeutics Programme, Cancer Science Institute of Singapore.'}, {'ForeName': 'Ross Andrew', 'Initials': 'RA', 'LastName': 'Soo', 'Affiliation': 'Department of Haematology-Oncology, National University Cancer Institute, Singapore.'}, {'ForeName': 'Jieying Amelia', 'Initials': 'JA', 'LastName': 'Lau', 'Affiliation': 'Cancer Science Institute of Singapore, National University of Singapore.'}, {'ForeName': 'Yu Yang', 'Initials': 'YY', 'LastName': 'Soon', 'Affiliation': 'Department of Radiation Oncology, National University Health System.'}, {'ForeName': 'Robby Miguel', 'Initials': 'RM', 'LastName': 'Goh', 'Affiliation': 'Department of Hematology-Oncology, National University Cancer Institute, Singapore.'}, {'ForeName': 'Francis Cho Hao', 'Initials': 'FCH', 'LastName': 'Ho', 'Affiliation': 'Department of Radiation Oncology, National University Health System.'}, {'ForeName': 'Siew Meng', 'Initials': 'SM', 'LastName': 'Chong', 'Affiliation': 'Department of Pathology, National University of Singapore.'}, {'ForeName': 'Soo-Chin', 'Initials': 'SC', 'LastName': 'Lee', 'Affiliation': 'Haematology-Oncology, National University Hospital (S) Pte Ltd.'}, {'ForeName': 'Kwok Seng', 'Initials': 'KS', 'LastName': 'Loh', 'Affiliation': 'Department of Otolaryngology- Head and Neck Surgery, National University of Singapore.'}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Epidemiology and Public Health, National University of Singapore.'}, {'ForeName': 'Yaw Chyn', 'Initials': 'YC', 'LastName': 'Lim', 'Affiliation': 'Department of Physiology, National University of Singapore.'}, {'ForeName': 'Boon Cher', 'Initials': 'BC', 'LastName': 'Goh', 'Affiliation': 'Department of Haematology-Oncology, National University Health System phcgbc@nus.edu.sg.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1727']
2928,32316854,Dynamic post-activation potentiation protocol improves rowing performance in experienced female rowers.,"Post-activation potentiation likely acutely improves power-based performance; however, few studies have demonstrated improved endurance performance. Forty collegiate female rowers performed isometric potentiating (ISO), dynamic potentiating (DYN) and control (CON) warm-up protocols on a rowing ergometer, followed by a three-minute all-out test to evaluate their total distance, peak power, mean power, critical power, anaerobic working capacity (W') and stroke rate. Fifteen-second splits were also analysed. ISO consisted of 5 × 5-second static muscle actions with the ergometer handle rendered immovable with a nylon strap, while DYN consisted of 2 × 10-second all-out rowing bouts, separated by a 2-minute rest interval. The participants were divided into high and low experience groups by median experience level (3.75 years) for statistical analysis. Significant differences (DYN > CON; p < 0.05) were found for distance (+5.6 m), mean power (+5.9 W) and W' (+1561.6 J) for more experienced rowers (n = 19) and no differences for less experienced rowers (n = 18). Mean power in DYN was significantly greater than CON and ISO in the 15-30, 30-45, 45-60 and 60-75 second intervals independent of experience level. These results suggest that DYN may benefit experienced female rowers and that these strategies might benefit a greater power output over shorter distances regardless of experience.",2020,"Significant differences (DYN > CON; p < 0.05) were found for distance (+5.6 m), mean power (+5.9 W) and W' (+1561.6 J) for more experienced rowers (n = 19) and no differences for less experienced rowers (n = 18).","['experienced female rowers', 'Forty collegiate female rowers performed']","['Dynamic post-activation potentiation protocol', 'isometric potentiating (ISO), dynamic potentiating (DYN) and control (CON) warm-up protocols on a rowing ergometer']","['endurance performance', 'rowing performance', ""total distance, peak power, mean power, critical power, anaerobic working capacity (W') and stroke rate"", 'Mean power in DYN']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}]","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}]",,0.0171604,"Significant differences (DYN > CON; p < 0.05) were found for distance (+5.6 m), mean power (+5.9 W) and W' (+1561.6 J) for more experienced rowers (n = 19) and no differences for less experienced rowers (n = 18).","[{'ForeName': 'Idan', 'Initials': 'I', 'LastName': 'Harat', 'Affiliation': 'Institute of Exercise Physiology and Rehabilitation Science, School of Kinesiology and Physical Therapy, University of Central Florida , Orlando, FL, USA.'}, {'ForeName': 'Nicolas W', 'Initials': 'NW', 'LastName': 'Clark', 'Affiliation': 'Institute of Exercise Physiology and Rehabilitation Science, School of Kinesiology and Physical Therapy, University of Central Florida , Orlando, FL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Boffey', 'Affiliation': 'Institute of Exercise Physiology and Rehabilitation Science, School of Kinesiology and Physical Therapy, University of Central Florida , Orlando, FL, USA.'}, {'ForeName': 'Chad H', 'Initials': 'CH', 'LastName': 'Herring', 'Affiliation': 'Institute of Exercise Physiology and Rehabilitation Science, School of Kinesiology and Physical Therapy, University of Central Florida , Orlando, FL, USA.'}, {'ForeName': 'Erica R', 'Initials': 'ER', 'LastName': 'Goldstein', 'Affiliation': 'Institute of Exercise Physiology and Rehabilitation Science, School of Kinesiology and Physical Therapy, University of Central Florida , Orlando, FL, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Redd', 'Affiliation': 'Institute of Exercise Physiology and Rehabilitation Science, School of Kinesiology and Physical Therapy, University of Central Florida , Orlando, FL, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Wells', 'Affiliation': 'Institute of Exercise Physiology and Rehabilitation Science, School of Kinesiology and Physical Therapy, University of Central Florida , Orlando, FL, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Stout', 'Affiliation': 'Institute of Exercise Physiology and Rehabilitation Science, School of Kinesiology and Physical Therapy, University of Central Florida , Orlando, FL, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Fukuda', 'Affiliation': 'Institute of Exercise Physiology and Rehabilitation Science, School of Kinesiology and Physical Therapy, University of Central Florida , Orlando, FL, USA.'}]",Journal of sports sciences,['10.1080/02640414.2020.1754110']
2929,32480401,The feasibility analysis of calculating proptosis by simple Heron's formula.,"PURPOSE


We propose a new method to calculate proptosis by using the simple Heron's formula and analyze its feasibility.
METHOD


It was a none-inferiority trial. The registration number was ChiCTR1900026490. The absolute value of proptosis in 120 eyes, 60 patients without eye injury or diseases, was measured by computed tomography (CT) and simple Heron's formula. We did regression analysis and analyzed the differences between the two methods with Medcalc software version 19.0.4. The result was showed by Passing-Bablok regression analysis diagram and Bland and Altman plot.
RESULTS


The Passing-Bablok showed that the result of proptosis measured by CT and simple Heron's formula showed good positive correlation. A 95% limit of agreement in proptosis between CT and Heron's formula method was -0.46 to 0.54 mm in right eye and -0.45 to 0.46 mm in left eye. 1.66% (1/60) point was outside 95% LoA in both eyes. Moreover, a 95% limit of agreement between CT and Heron's formula method was -0.42 to 0.56 mm in difference of both eyes. 3.33% (2/60) points were outside 95% LoA. The points in all Bland and Altman plots were lower than 5%. It means that the results of comparison between the two methods had a good consistency in the measurement of proptosis.
CONCLUSIONS


Heron's formula could be applied to calculate proptosis and has a good consistency compared with computed tomography (CT). This method is practical in proptosis assessment because of its accuracy, reliability and simplicity.",2020,"The absolute value of proptosis in 120 eyes, 60 patients without eye injury or diseases, was measured by computed tomography (CT) and simple Heron's formula.","[""120 eyes, 60 patients without eye injury or diseases, was measured by computed tomography (CT) and simple Heron's formula""]",['computed tomography (CT'],[],"[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015408', 'cui_str': 'Eye injury'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0325437', 'cui_str': 'Heron'}]","[{'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]",[],60.0,0.0333971,"The absolute value of proptosis in 120 eyes, 60 patients without eye injury or diseases, was measured by computed tomography (CT) and simple Heron's formula.","[{'ForeName': 'Weili', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Peking University Shenzhen Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Qinying', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Department of Ophthalmology, Peking University Shenzhen Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Yile', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, Peking University Shenzhen Hospital, Shenzhen, Guangdong, China.'}, {'ForeName': 'Jinying', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Peking University Shenzhen Hospital, Shenzhen, Guangdong, China.'}]",PloS one,['10.1371/journal.pone.0234016']
2930,32827645,Evaluation of Gasless Laparoscopy as a Tool for Minimal Access Surgery in Low- to Middle-Income Countries: A Phase II Non-Inferiority Randomized Controlled Study.,"BACKGROUND


Minimal access surgery [MAS] is not available to most people in the rural areas of Low Middle-Income Countries [LMIC]. This leads to an increase in the morbidity and the economic loss to the poor and the marginalized. The Gasless laparoscopic surgeries [GAL] are possible in rural areas as they could be carried out under spinal-anaesthesia. In most cases, it does not require the logistics of providing gases for pneumoperitoneum and general anaesthesia. The current study compares GAL with conventional Laparoscopic surgeries [COL] for general surgical procedures METHODS: A single-centre, non-blinded randomized control trial [RCT] was conducted to evaluate non - inferiority of GAL versus COL at a teaching hospital in New Delhi. Patients were allocated into two groups and underwent MAS (Cholecystectomies and appendectomies). The procedure was carried out by two surgeons by randomly choosing between GAL and COL. The data was collected by postgraduates and analyzed by a biostatistician.
RESULTS


100 patients who met the inclusion criteria were allocated into two groups. No significant difference was observed in the mean operating time between GAL group (52.9 min) vs COL group (55 minutes) [p=0.3]. The intraoperative vital signs were better in the GAL group [p < 0.05]. The postoperative pain score was slightly higher in the GAL group [p = 0.01]; however, it did not require additional analgesics.
CONCLUSIONS


No significant differences were found between the two groups. GAL can be classed as non-inferior compared to COL and has the potential to be adopted in low resource settings.",2020,The intraoperative vital signs were better in the GAL group [p < 0.05].,['100 patients who met the inclusion criteria'],"['GAL versus COL', 'MAS (Cholecystectomies and appendectomies', 'Gasless Laparoscopy', 'RCT', 'Gasless laparoscopic surgeries [GAL', 'Minimal access surgery [MAS', 'GAL', 'conventional Laparoscopic surgeries [COL']","['postoperative pain score', 'mean operating time', 'intraoperative vital signs']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0060993', 'cui_str': 'Galanin'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}]",100.0,0.035368,The intraoperative vital signs were better in the GAL group [p < 0.05].,"[{'ForeName': 'Anurag', 'Initials': 'A', 'LastName': 'Mishra', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi. Electronic address: anurag.alok@gmail.com.'}, {'ForeName': 'Lovenish', 'Initials': 'L', 'LastName': 'Bains', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi.'}, {'ForeName': 'Gnanaraj', 'Initials': 'G', 'LastName': 'Jesudin', 'Affiliation': 'Project GILLS Association of Rural Surgeons of India.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Aruparayil', 'Affiliation': ""Leeds Institute of Medical Research at St. James's, University of Leeds, UK.""}, {'ForeName': 'Rajdeep', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Shashi', 'Affiliation': 'Department of Surgery, Maulana Azad Medical College, New Delhi.'}]",Journal of the American College of Surgeons,['10.1016/j.jamcollsurg.2020.07.783']
2931,32827709,Acute effect of inspiratory resistive loading on sprint interval exercise performance in team-sport athletes.,"This study examined acute effects of inspiratory resistive loading (IRL) during rest intervals on sprint interval exercise (SIE) performance. In a randomized crossover design, nine collegiate basketball players performed IRL (15 cmH 2 O) or passive recovery (CON) at 5-min rest intervals during and immediately after 6 sets of a 30-s SIE test. Performance, muscular oxygenation of vastus lateralis, blood lactate and pH were measured at each condition. Blood lactate at 5-min (-20.5%) and 20-min (-21.3%) after SIE were significantly lower in IRL than in CON. The pH at 5-min after SIE was significantly higher in IRL than in CON (+0.8%, p <  0.05). However, the total work in IRL was significantly lower than in CON (-2.7%, p <  0.05). Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5%, p <  0.05). The IRL could attenuate exercise-induced metabolic acidosis; however, the decreased blood flow at rest intervals might increase the physical challenge in SIE.",2020,"Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5%, p <  0.05).",['team-sport athletes'],"['inspiratory resistive loading (IRL', 'CON', 'inspiratory resistive loading', 'IRL (15\u2009cmH 2 O) or passive recovery (CON']","['sprint interval exercise performance', 'Blood lactate', 'IRL', 'sprint interval exercise (SIE) performance', 'total hemoglobin at rest intervals in IRL', 'blood flow', 'Performance, muscular oxygenation of vastus lateralis, blood lactate and pH', 'total work in IRL']","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0949658', 'cui_str': 'Primary familial hypertrophic cardiomyopathy'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0475206', 'cui_str': '% total hemoglobin'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0557351', 'cui_str': 'Employed'}]",,0.0174742,"Average changes in total hemoglobin at rest intervals in IRL were significantly lower than in CON (-34.5%, p <  0.05).","[{'ForeName': 'Ching-Feng', 'Initials': 'CF', 'LastName': 'Cheng', 'Affiliation': 'Department of Athletic Performance, National Taiwan Normal University, Taipei, Taiwan; Sports performance lab, National Taiwan Normal University, Taipei, Taiwan. Electronic address: andescheng@ntnu.edu.tw.'}, {'ForeName': 'Wei-Chieh', 'Initials': 'WC', 'LastName': 'Hsu', 'Affiliation': 'Sports performance lab, National Taiwan Normal University, Taipei, Taiwan; Graduate Institute of Sports Training, University of Taipei, Taipei, Taiwan.'}, {'ForeName': 'Yu-Hsuan', 'Initials': 'YH', 'LastName': 'Kuo', 'Affiliation': 'Sports performance lab, National Taiwan Normal University, Taipei, Taiwan; Department of Physical Education, Chinese Culture University, Taipei, Taiwan.'}, {'ForeName': 'Tzu-Wei', 'Initials': 'TW', 'LastName': 'Chen', 'Affiliation': 'Physical Education Office, National Chengchi University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Chi', 'Initials': 'YC', 'LastName': 'Kuo', 'Affiliation': 'Department of Exercise and Health Science, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103531']
2932,32816521,A Randomized Controlled Trial Comparing Traditional Plaster Cast Rehabilitation With Functional Walking Boot Rehabilitation for Acute Achilles Tendon Ruptures.,"BACKGROUND


There has been a shift toward functional nonoperative rehabilitation in the treatment of Achilles tendon rupture (ATR) despite a shortage of studies directly comparing nonoperative functional rehabilitation with traditional nonoperative immobilization.
PURPOSE


To compare patient-reported outcome measures and functional outcomes for nonoperatively treated ATR with traditional cast immobilization or functional rehabilitation in a walking boot.
STUDY DESIGN


Randomized controlled clinical trial; Level of evidence, 2.
METHODS


In a single-center nonblinded study, 140 patients were randomized to compare treatment for acute ATR in (1) an immobilizing cast in reducing degrees of equinus over a 10-week period with 8 weeks of nonweightbearing mobilization or (2) a walking boot for 8 weeks with reducing equinus and immediate full weightbearing. Exclusion criteria were delayed presentation >2 weeks after injury, tendon reruptures, and latex allergy. Analysis was undertaken on an intention-to-treat basis.
RESULTS


A total of 69 patients (median age, 41 years [interquartile range, 33-50.5 years]) were randomized to walking boot treatment and 71 patients (41 [32-49]) to cast treatment. At 6 months, patients treated in a walking boot reported better Short Musculoskeletal Function Assessment (SMFA) dysfunction index (6.62 [2.21-12.50] vs 10.66 [4.96-13.42];  P  = .050), SMFA bother index (7.29 [2.08-14.58] vs 10.42 [5.73-19.27];  P  = .04), Achilles Tendon Total Rupture Score (71.5 [53.50-84.25] vs 54.0 [37-76];  P  = .01), and Foot and Ankle Questionnaire core score (91 [81.89-97.55] vs 85 [78.25-92.09];  P  = .04). At 1 year, there was no difference in SMFA dysfunction index (2.21 [0.74-5.88] vs 2.94 [1.47-6.62];  P  = .25), SMFA bother index (2.08 [0-9.38] vs 5.21 [0.52-11.98];  P  = .25), Achilles Tendon Total Rupture Score (92 [72.50-96] vs 87.5 [66.0-94.75];  P  = .21), or Foot and Ankle Questionnaire core score (97.75 [89.46-99.00] vs 95.50 [90.88-97.50];  P  = .18). Rerupture occurred in 5 and 11 patients ( P  = .075) and venous thromboembolism in 2 and 3 patients ( P  = .67) in the boot and cast groups, respectively. Fifteen patients in the boot group but none in the cast group had skin problems ( P  < .001). Patients treated in a boot returned to driving at a median 12 weeks (vs 13 weeks for cast;  P  = .045), but there was no difference in time to return to work ( P  = .48).
CONCLUSION


Functional rehabilitation with early weightbearing is a safe alternative to traditional immobilizing treatment for ATR, giving better early functional outcomes, albeit with a higher incidence of transient minor skin complications.
REGISTRATION


NCT02598843 (ClinicalTrials.gov identifier).",2020,"Rerupture occurred in 5 and 11 patients ( P  = .075) and venous thromboembolism in 2 and 3 patients ( P  = .67) in the boot and cast groups, respectively.","['69 patients (median age, 41 years [interquartile range, 33-50.5 years', '140 patients', 'Acute Achilles Tendon Ruptures', 'Achilles tendon rupture (ATR']","['traditional cast immobilization or functional rehabilitation', 'Traditional Plaster Cast Rehabilitation With Functional Walking Boot Rehabilitation', 'immobilizing cast in reducing degrees of equinus over a 10-week period with 8 weeks of nonweightbearing mobilization or (2) a walking boot for 8 weeks with reducing equinus and immediate full weightbearing', 'walking boot treatment']","['Short Musculoskeletal Function Assessment (SMFA) dysfunction index', 'Rerupture', 'SMFA dysfunction index', 'skin problems', 'SMFA bother index', 'venous thromboembolism', 'Foot and Ankle Questionnaire core score', 'Achilles Tendon Total Rupture Score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0020944', 'cui_str': 'Immobilization - action'}, {'cui': 'C0454532', 'cui_str': 'Functional rehabilitation'}, {'cui': 'C0032159', 'cui_str': 'Plaster cast'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1318107', 'cui_str': 'Load-Bearing'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0026861', 'cui_str': 'Musculoskeletal function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0281822', 'cui_str': 'Skin problem'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}]",140.0,0.180691,"Rerupture occurred in 5 and 11 patients ( P  = .075) and venous thromboembolism in 2 and 3 patients ( P  = .67) in the boot and cast groups, respectively.","[{'ForeName': 'Julian F', 'Initials': 'JF', 'LastName': 'Maempel', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Nick D', 'Initials': 'ND', 'LastName': 'Clement', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Duckworth', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Oisin J F', 'Initials': 'OJF', 'LastName': 'Keenan', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Tim O', 'Initials': 'TO', 'LastName': 'White', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Leela C', 'Initials': 'LC', 'LastName': 'Biant', 'Affiliation': 'University of Manchester Medical School, Manchester, UK.'}]",The American journal of sports medicine,['10.1177/0363546520944905']
2933,32816626,Effects of a Combination of Extracts from Olive Fruit and Almonds Skin on Oxidative and Inflammation Markers in Hypercholesterolemic Subjects: A Randomized Controlled Trial.,"Hydroxytyrosol (HT) from olives and polyphenols from almond skin (ASPs) possess cardioprotective properties. This pilot study evaluates the effect of supplementation with a combination of olive fruit and almond skin extracts on low-density lipoprotein (LDL) cholesterol oxidation, lipid homeostasis, and inflammatory parameters in adults with moderate hypercholesterolemia. A randomized, parallel, double-blind, placebo-controlled pilot study of 8 weeks was performed. The extract group (EG) received the supplement with 7.5 mg HT +210 mg ASPs, and the control group (CG) received a placebo composed of maltodextrin. Oxidized LDL (oxLDL) levels and the oxLDL/LDL ratio were lower in the EG than in the CG after 8 weeks of treatment (18.76 ± 3.91 vs. 10.34 ± 4.22,  P  < .001 and 0.151 ± 0.025 vs. 0.08 ± 0.023,  P  < .001, respectively). Interleukin-1β levels were significantly higher in the CG than in the EG at week 4 ( P  = .004), IL-6 was significantly higher in the CG than in the EG at week 4 ( P  = .049), and IL-10 was significantly increased at week 4 in both groups ( P  = .002 for CG and  P  = .001 for EG). In conclusion, daily consumption of a combination of an olive fruit extract and an almond skin extract for 8 weeks seems to protect LDL from oxidation and to prevent inflammatory status in moderately hypercholesterolemic subjects.",2020,"Interleukin-1β levels were significantly higher in the CG than in the EG at week 4 ( P  = .004), IL-6 was significantly higher in the CG than in the EG at week 4 ( P  = .049), and IL-10 was significantly increased at week 4 in both groups ( P  = .002 for CG and  P  = .001 for EG).","['Hypercholesterolemic Subjects', 'moderately hypercholesterolemic subjects', 'adults with moderate hypercholesterolemia']","['placebo composed of maltodextrin', 'olive fruit and almond skin extracts', 'olive fruit extract and an almond skin extract', 'Hydroxytyrosol (HT) from olives and polyphenols from almond skin (ASPs', 'Combination of Extracts from Olive Fruit and Almonds Skin', 'supplement with 7.5\u2009mg HT +210\u2009mg ASPs', 'placebo']","['low-density lipoprotein (LDL) cholesterol oxidation, lipid homeostasis, and inflammatory parameters', 'Oxidized LDL (oxLDL) levels and the oxLDL/LDL ratio', 'IL-6', 'Interleukin-1β levels', 'Oxidative and Inflammation Markers', 'IL-10']","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0228539', 'cui_str': 'Olivary nucleus structure'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0440286', 'cui_str': 'Almond'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0243264', 'cui_str': 'hydroxytyrosol'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0004015', 'cui_str': 'Aspartic Acid'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4319559', 'cui_str': '210'}]","[{'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.125273,"Interleukin-1β levels were significantly higher in the CG than in the EG at week 4 ( P  = .004), IL-6 was significantly higher in the CG than in the EG at week 4 ( P  = .049), and IL-10 was significantly increased at week 4 in both groups ( P  = .002 for CG and  P  = .001 for EG).","[{'ForeName': 'Juristo', 'Initials': 'J', 'LastName': 'Fonollá', 'Affiliation': 'Research and Development Department, Biosearch Life, Granada, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Maldonado-Lobón', 'Affiliation': 'Research and Development Department, Biosearch Life, Granada, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Luque', 'Affiliation': 'Research and Development Department, Biosearch Life, Granada, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Rodríguez', 'Affiliation': 'Research and Development Department, Biosearch Life, Granada, Spain.'}, {'ForeName': 'Óscar', 'Initials': 'Ó', 'LastName': 'Bañuelos', 'Affiliation': 'Research and Development Department, Biosearch Life, Granada, Spain.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'López-Larramendi', 'Affiliation': 'Commercial and Marketing Department, Biosearch Life, Granada, Spain.'}, {'ForeName': 'Mónica', 'Initials': 'M', 'LastName': 'Olivares', 'Affiliation': 'Research and Development Department, Biosearch Life, Granada, Spain.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Blanco-Rojo', 'Affiliation': 'Research and Development Department, Biosearch Life, Granada, Spain.'}]",Journal of medicinal food,['10.1089/jmf.2020.0088']
2934,32816629,Long-Term Outcomes of Laparoscopic Distal Gastrectomy for Locally Advanced Gastric Cancer: The KLASS-02-RCT Randomized Clinical Trial.,"PURPOSE


It is unclear whether laparoscopic distal gastrectomy for locally advanced gastric cancer is oncologically equivalent to open distal gastrectomy. The noninferiority of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer compared with open surgery in terms of 3-year relapse-free survival rate was evaluated.
PATIENTS AND METHODS


A phase III, open-label, randomized controlled trial was conducted for patients with histologically proven locally advanced gastric adenocarcinoma suitable for distal subtotal gastrectomy. The primary end point was the 3-year relapse-free survival rate; the upper limit of the hazard ratio (HR) for noninferiority was 1.43 between the laparoscopic and open distal gastrectomy groups.
RESULTS


From November 2011 to April 2015, 1,050 patients were randomly assigned to laparoscopy (n = 524) or open surgery (n = 526). After exclusions, 492 patients underwent laparoscopic surgery and 482 underwent open surgery and were included in the analysis. The laparoscopy group, compared with the open surgery group, suffered fewer early complications (15.7%  v  23.4%, respectively;  P  = .0027) and late complications (4.7%  v  9.5%, respectively;  P  = .0038), particularly intestinal obstruction (2.0%  v  4.4%, respectively;  P  = .0447). The 3-year relapse-free survival rate was 80.3% (95% CI, 76.0% to 85.0%) for the laparoscopy group and 81.3% (95% CI, 77.0% to 85.0%; log-rank  P  = .726) for the open group. Cox regression analysis after stratification by the surgeon revealed an HR of 1.035 (95% CI, 0.762 to 1.406; log-rank  P  = .827;  P  for noninferiority = .039). When stratified by pathologic stage, the HR was 1.020 (95% CI, 0.751 to 1.385; log-rank  P  = .900;  P  for noninferiority = .030).
CONCLUSION


Laparoscopic distal gastrectomy with D2 lymphadenectomy was comparable to open surgery in terms of relapse-free survival for patients with locally advanced gastric cancer. Laparoscopic distal gastrectomy with D2 lymphadenectomy could be a potential standard treatment option for locally advanced gastric cancer.",2020,It is unclear whether laparoscopic distal gastrectomy for locally advanced gastric cancer is oncologically equivalent to open distal gastrectomy.,"['patients with histologically proven locally advanced gastric adenocarcinoma suitable for distal subtotal gastrectomy', 'From November 2011 to April 2015, 1,050 patients', 'locally advanced gastric cancer', 'patients with locally advanced gastric cancer', '492 patients underwent laparoscopic surgery and 482 underwent open surgery and were included in the analysis', 'Locally Advanced Gastric Cancer']","['laparoscopic distal gastrectomy', 'Laparoscopic distal gastrectomy with D2 lymphadenectomy', 'laparoscopy', 'Laparoscopic Distal Gastrectomy', 'laparoscopic subtotal gastrectomy with D2 lymphadenectomy', 'open surgery']","['particularly intestinal obstruction', 'early complications', '3-year relapse-free survival rate', 'late complications', '3-year relapse-free survival rate; the upper limit of the hazard ratio (HR) for noninferiority', 'relapse-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278701', 'cui_str': 'Adenocarcinoma of stomach'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0192440', 'cui_str': 'Distal subtotal gastrectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0030600', 'cui_str': 'Subtotal gastrectomy'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}]","[{'cui': 'C0021843', 'cui_str': 'Intestinal obstruction'}, {'cui': 'C0231243', 'cui_str': 'Early complication'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",1050.0,0.133667,It is unclear whether laparoscopic distal gastrectomy for locally advanced gastric cancer is oncologically equivalent to open distal gastrectomy.,"[{'ForeName': 'Woo Jin', 'Initials': 'WJ', 'LastName': 'Hyung', 'Affiliation': 'Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Han-Kwang', 'Initials': 'HK', 'LastName': 'Yang', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Kyu', 'Initials': 'YK', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Chonnam National University Hwasun Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Hyuk-Joon', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Yeong', 'Initials': 'JY', 'LastName': 'An', 'Affiliation': 'Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Wook', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': ""Department of Surgery, Yeouido St Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.""}, {'ForeName': 'Hyoung-Il', 'Initials': 'HI', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyung-Ho', 'Initials': 'HH', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Seung Wan', 'Initials': 'SW', 'LastName': 'Ryu', 'Affiliation': 'Keimyung University Dongsan Medical Center, Daegu, Republic of Korea.'}, {'ForeName': 'Hoon', 'Initials': 'H', 'LastName': 'Hur', 'Affiliation': 'Department of Surgery, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Min-Chan', 'Initials': 'MC', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Dong-A University Hospital, Korea, Busan, Republic of Korea.'}, {'ForeName': 'Seong-Ho', 'Initials': 'SH', 'LastName': 'Kong', 'Affiliation': 'Department of Surgery, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Gyu Seok', 'Initials': 'GS', 'LastName': 'Cho', 'Affiliation': 'Department of Surgery, Soonchunhyang University Bucheon Hospital, Bucheon, Republic of Korea.'}, {'ForeName': 'Jin-Jo', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': ""Department of Surgery, Incheon St Mary's Hospital, The Catholic University of Korea, Incheon, Republic of Korea.""}, {'ForeName': 'Do Joong', 'Initials': 'DJ', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.'}, {'ForeName': 'Keun Won', 'Initials': 'KW', 'LastName': 'Ryu', 'Affiliation': 'Center for Gastric Cancer, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Young Woo', 'Initials': 'YW', 'LastName': 'Kim', 'Affiliation': 'Center for Gastric Cancer, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Jong Won', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Yonsei University Gangnam Severance Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Joo-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, Ewha Womans University Mokdong Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sang-Uk', 'Initials': 'SU', 'LastName': 'Han', 'Affiliation': 'Department of Surgery, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01210']
2935,32816630,Individual Patient Data Meta-Analysis of FOLFOXIRI Plus Bevacizumab Versus Doublets Plus Bevacizumab as Initial Therapy of Unresectable Metastatic Colorectal Cancer.,"PURPOSE


A proper estimation of the magnitude of the overall survival (OS) benefit from infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) plus bevacizumab versus doublets + bevacizumab is lacking because all trials that have investigated this regimen had primary end points other than OS. To test OS with higher power and to explore the interaction of treatment effect with main patient and disease characteristics, we performed an individual patient data (IPD) meta-analysis.
PATIENTS AND METHODS


IPD from 5 eligible trials were collected: CHARTA (ClinicalTrials.gov identifier: NCT01321957), OLIVIA (ClinicalTrials.gov identifier: NCT00778102), STEAM (ClinicalTrials.gov identifier: NCT01765582), TRIBE (ClinicalTrials.gov identifier: NCT00719797), and TRIBE2 (ClinicalTrials.gov identifier: NCT02339116). The primary end point was OS. Secondary end points were progression-free survival (PFS), objective response rate (ORR), R0 resection rate, grade 3/4 adverse events, and subgroup analyses according to clinical and molecular characteristics.
RESULTS


A total of 1,697 patients were randomly assigned to FOLFOXIRI + bevacizumab (n = 846) or doublets + bevacizumab (n = 851). Most (78%) had an Eastern Cooperative Oncology Group performance status of 0, and the median age was 61 years. After a median follow-up of 39.9 months, patients assigned to FOLFOXIRI + bevacizumab had significantly longer OS than those assigned to doublets + bevacizumab (median, 28.9  v  24.5 months; hazard ratio [HR], 0.81; 95% CI, 0.72 to 0.91;  P  < .001), with no significant heterogeneity among trials ( P  = .39; I 2  = 2%). No significant interaction effect between treatment arm and investigated characteristics was demonstrated. Patients assigned to FOLFOXIRI + bevacizumab had longer PFS (median, 12.2  v  9.9 months; HR, 0.74; 95% CI, 0.67 to 0.82;  P  < .001), higher ORR (64.5%  v  53.6%;  P  < .001), higher R0 resection rate (16.4%  v  11.8%;  P  = .007), and higher rates of grade 3/4 neutropenia (45.8%  v  21.5%;  P  < .001), febrile neutropenia (6.3%  v  3.7%;  P  = .019), and diarrhea (17.8%  v  8.4%;  P  < .001).
CONCLUSION


FOLFOXIRI + bevacizumab significantly and meaningfully improves survival of patients with metastatic colorectal cancer compared with doublets + bevacizumab and provides advantage in PFS, ORR, and R0 resection rate at the price of a moderate increase in toxicity. No increased benefit is observed among patients with  BRAF -mutant tumors.",2020,"Patients assigned to FOLFOXIRI + bevacizumab had longer PFS (median, 12.2  v  9.9 months; HR, 0.74; 95% CI, 0.67 to 0.82;  P  < .001), higher ORR (64.5%  v  53.6%;  P  < .001), higher R0 resection rate (16.4%  v  11.8%;  P  = .007), and higher rates of grade 3/4 neutropenia (45.8%  v  21.5%;  P  < .001), febrile neutropenia (6.3%  v  3.7%;  P  = .019), and diarrhea (17.8%  v  8.4%;  P  < .001).
","['Unresectable Metastatic Colorectal Cancer', 'patients with metastatic colorectal cancer', '1,697 patients', 'IPD from 5 eligible trials', 'patients with  BRAF -mutant tumors']","['infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) plus bevacizumab versus doublets + bevacizumab', 'doublets + bevacizumab', 'FOLFOXIRI + bevacizumab', 'Bevacizumab']","['higher R0 resection rate', 'diarrhea', 'OS', 'higher ORR', 'febrile neutropenia', 'PFS, ORR, and R0 resection rate', 'longer OS', 'overall survival', 'longer PFS', 'survival', 'toxicity', 'rates of grade 3/4 neutropenia', 'progression-free survival (PFS), objective response rate (ORR), R0 resection rate, grade 3/4 adverse events, and subgroup analyses according to clinical and molecular characteristics']","[{'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",1697.0,0.410772,"Patients assigned to FOLFOXIRI + bevacizumab had longer PFS (median, 12.2  v  9.9 months; HR, 0.74; 95% CI, 0.67 to 0.82;  P  < .001), higher ORR (64.5%  v  53.6%;  P  < .001), higher R0 resection rate (16.4%  v  11.8%;  P  = .007), and higher rates of grade 3/4 neutropenia (45.8%  v  21.5%;  P  < .001), febrile neutropenia (6.3%  v  3.7%;  P  = .019), and diarrhea (17.8%  v  8.4%;  P  < .001).
","[{'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Cremolini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Antoniotti', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'Hematology-Oncology Practice Hamburg (HOPE), University Cancer Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Bendell', 'Affiliation': 'Sarah Cannon Research Institute/Tennessee Oncology, Nashville, TN.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gruenberger', 'Affiliation': 'Social Medical Center South, Department of Surgery, HPB Center Vienna Clinics and Sigmund Freud University, Medical School, Vienna, Austria.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Rossini', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Masi', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ongaro', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Hurwitz', 'Affiliation': 'Genentech, South San Francisco, CA.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Falcone', 'Affiliation': 'Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Schmoll', 'Affiliation': 'Department Internal Medicine IV-Hematology-Oncology, Martin-Luther-University, Halle (Saale), Germany.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Di Maio', 'Affiliation': 'Department of Oncology, University of Turin, Mauriziano Hospital, Turin, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.01225']
2936,32816639,Buspirone Decreases Susceptibility to Hypocapnic Central Sleep Apnea in Chronic SCI Patients.,"Spinal cord injury (SCI) is a risk factor for central sleep apnea (CSA). Previous studies in animal models with SCI have demonstrated a promising recovery in respiratory and phrenic nerve activity post-injury induced by the systemic and local administration of serotonin receptor agonists such as Buspirone and Trazodone. Human trials must be performed to determine if individuals with SCI respond similarly. We hypothesized that Buspirone and Trazodone would decrease the propensity to hypocapnic CSA during sleep. We studied 8 males with chronic SCI and sleep-disordered breathing (SDB)(Age: 48.8±14.2; AHI: 44.9±23.1) in a single-blind crossover design. For 13 days participants were randomly assigned either Buspirone (7.5-15mg twice daily), Trazodone (100mg) or a placebo followed by a 14-day washout period before crossing over to the other interventions. Study nights included polysomnography and induction of CSA using a non-invasive ventilation protocol. We assessed indices of SDB, CO 2  reserve, apneic threshold (AT), controller gain (CG), plant gain (PG) and ventilatory parameters. CO 2  reserve was significantly widened on Buspirone (-3.6±0.9mmHg) compared to both Trazodone (-2.5±1.0mmHg; p=0.009) and placebo (-1.8±1.5mmHg; p<0.001) but not on Trazodone vs. placebo (p=0.061). CG was significantly decreased on Buspirone compared to placebo (1.8±0.4 vs 4.0±2.0L/(mmHg*min); p=0.025) but not on Trazodone compared to placebo (2.5±1.1 vs. 4.0±2.0L/(mmHg*min); p=0.065). There were no significant differences for PG, AT or any SDB indices (AHI, OAI, CAI, ODI). The administration of Buspirone decreased the susceptibility to induced hypocapnic central apnea by reducing chemosensitivity and increasing CO 2  reserve in chronic SCI patients.",2020,"There were no significant differences for PG, AT or any SDB indices (AHI, OAI, CAI, ODI).","['individuals with SCI respond similarly', '8 males with chronic SCI and sleep-disordered breathing (SDB)(Age', 'Chronic SCI Patients', 'chronic SCI patients']","['Trazodone', 'Buspirone and Trazodone', 'Buspirone', 'Trazodone vs. placebo', 'placebo']","['PG, AT or any SDB indices (AHI, OAI, CAI, ODI', 'CO 2  reserve', 'SDB, CO 2  reserve, apneic threshold (AT), controller gain (CG), plant gain (PG) and ventilatory parameters', 'CG']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0851578', 'cui_str': 'Sleep disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0040805', 'cui_str': 'Trazodone'}, {'cui': 'C0006462', 'cui_str': 'Buspirone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0064494', 'cui_str': 'carboxyamido-triazole'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",8.0,0.0422913,"There were no significant differences for PG, AT or any SDB indices (AHI, OAI, CAI, ODI).","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Maresh', 'Affiliation': 'Internal Medicine, Wayne State University, United States.'}, {'ForeName': 'Joel L', 'Initials': 'JL', 'LastName': 'Prowting', 'Affiliation': 'Division of Pulmonary and Critical Care and Sleep Medicine, Wayne State University, United States.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Vaughan', 'Affiliation': 'John D. Dingell Veterans Affairs Medical Center.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kruppe', 'Affiliation': 'Wayne State University School of Medicine, John D. Dingell VAMC, United States.'}, {'ForeName': 'Bander', 'Initials': 'B', 'LastName': 'Alsabri', 'Affiliation': 'Wayne State University School of Medicine, John D. Dingell VAMC, United States.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Yarandi', 'Affiliation': 'Wayne State University, United States.'}, {'ForeName': 'M Safwan', 'Initials': 'MS', 'LastName': 'Badr', 'Affiliation': 'Department of Internal Medicine, Wayne State University School of Medicine, United States.'}, {'ForeName': 'Abdulghani', 'Initials': 'A', 'LastName': 'Sankari', 'Affiliation': 'Internal Medicine, Wayne State University School of Medicine, John D. Dingell VAMC, United States.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00435.2020']
2937,32825070,Incentivizing Commuter Cycling by Financial and Non-Financial Rewards.,"Current mobility patterns over-rely on transport modes that do not benefit sustainable and healthy lifestyles. To explore the potential for active mobility, we conducted a randomized experiment aimed at increasing regular commuter cycling in cities. In designing the experiment, we teamed up with developers of the ""Cyclers"" smartphone app to improve the effectiveness of the app by evaluating financial and non-financial motivational features. Participants in the experiment were recruited among new users of the app, and were randomly assigned to one of four different motivational treatments (smart gamification, two variants of a financial reward, and a combination of smart gamification and a financial reward) or a control group (no specific motivation). Our analysis suggests that people can be effectively motivated to engage in more frequent commuter cycling with incentives via a smartphone app. Offering small financial rewards seems to be more effective than smart gamification. A combination of both motivational treatments-smart gamification and financial rewards-may work the same or slightly better than financial rewards alone. We demonstrate that small financial rewards embedded in smartphone apps such as ""Cyclers"" can be effective in nudging people to commute by bike more often.",2020,"Participants in the experiment were recruited among new users of the app, and were randomly assigned to one of four different motivational treatments (smart gamification, two variants of a financial reward, and a combination of smart gamification and a financial reward) or a control group (no specific motivation).","['Participants in the experiment were recruited among new users of the app', 'cities']","['motivational treatments (smart gamification, two variants of a financial reward, and a combination of smart gamification and a financial reward) or a control group (no specific motivation']",[],"[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0235048', 'cui_str': 'Smarting pain'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",[],,0.0338274,"Participants in the experiment were recruited among new users of the app, and were randomly assigned to one of four different motivational treatments (smart gamification, two variants of a financial reward, and a combination of smart gamification and a financial reward) or a control group (no specific motivation).","[{'ForeName': 'Vojtěch', 'Initials': 'V', 'LastName': 'Máca', 'Affiliation': 'Environment Centre, Charles University, 162 00 Prague, Czech Republic.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Ščasný', 'Affiliation': 'Environment Centre, Charles University, 162 00 Prague, Czech Republic.'}, {'ForeName': 'Iva', 'Initials': 'I', 'LastName': 'Zvěřinová', 'Affiliation': 'Environment Centre, Charles University, 162 00 Prague, Czech Republic.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Jakob', 'Affiliation': 'FEE, Artificial Intelligence Center, Czech Technical University in Prague, 121 35 Prague, Czech Republic.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hrnčíř', 'Affiliation': 'Umotional s.r.o., 120 00 Prague, Czech Republic.'}]",International journal of environmental research and public health,['10.3390/ijerph17176033']
2938,32825282,Impact of Nurses' Intervention in the Prevention of Falls in Hospitalized Patients.,"BACKGROUND


Clinical safety is a crucial component of healthcare quality, focused on identifying and avoiding the risks to which patients are exposed. Among the adverse events that occur in a hospital environment, falls have a large impact (1.9-10% of annual income in acute care hospitals); they can cause pain, damage, costs, and mistrust in the health system. Our objective was to assess the effect of an educational intervention aimed at hospital nurses (systematic assessment of the risk of falls) in reducing the incidence of falls.
METHODS


this was a quasi-experimental study based on a sample of 581 patients in a third level hospital (Comunitat Valenciana, Spain). An educational program was given to the intervention group ( n  = 303), and a control group was included for comparison ( n  = 278). In the intervention group, the nurses participated in a training activity on the systematized assessment of the risk of falls. Analysis was undertaken using the Bayesian logistic regression model.
RESULTS


a total of 581 patients were studied (50.6% male, 49.4% female), with an average age of 68.3 (DT = 9) years. The overall incidence of falls was 1.2% (0.3% in the intervention group and 2.2% in the control group). Most of the falls occurred in people ≥65 years old (85.7%). The intervention group had a lower probability of falling than the control group (OR: 0.127; IC95%: 0.013-0.821). Neither the length of hospital stay, nor the age of the participants, had any relevant effect.
CONCLUSIONS


the systematic assessment of the risk of a patient falling during hospital processes is an effective intervention to reduce the incidence of falls.",2020,The intervention group had a lower probability of falling than the control group (OR: 0.127; IC95%: 0.013-0.821).,"['Hospitalized Patients', 'a total of 581 patients were studied (50.6% male, 49.4% female), with an average age of 68.3 (DT = 9) years', '581 patients in a third level hospital (Comunitat Valenciana, Spain']","['educational intervention', ""Nurses' Intervention""]","['lower probability of falling', 'length of hospital stay', 'overall incidence of falls']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",581.0,0.0392586,The intervention group had a lower probability of falling than the control group (OR: 0.127; IC95%: 0.013-0.821).,"[{'ForeName': 'Raimunda', 'Initials': 'R', 'LastName': 'Montejano-Lozoya', 'Affiliation': 'Escuela Enfermería La Fe, Valencia (Spain), adscript center of Universitat de Valencia, Research Group GREIACC, Health Research Institute La Fe, 46026 Valencia, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Miguel-Montoya', 'Affiliation': 'Escuela Enfermería La Fe, Valencia (Spain), adscript center of Universitat de Valencia, Research Group GREIACC, Health Research Institute La Fe, 46026 Valencia, Spain.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Gea-Caballero', 'Affiliation': 'Escuela Enfermería La Fe, Valencia (Spain), adscript center of Universitat de Valencia, Research Group GREIACC, Health Research Institute La Fe, 46026 Valencia, Spain.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Mármol-López', 'Affiliation': 'Escuela Enfermería La Fe, Valencia (Spain), adscript center of Universitat de Valencia, Research Group GREIACC, Health Research Institute La Fe, 46026 Valencia, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ruíz-Hontangas', 'Affiliation': 'Escuela Enfermería La Fe, Valencia (Spain), adscript center of Universitat de Valencia, Research Group GREIACC, Health Research Institute La Fe, 46026 Valencia, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Ortí-Lucas', 'Affiliation': 'Public Health Department, Catholic University of Valencia, 46001 Valencia, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17176048']
2939,32825324,High-Dose Vitamin D Supplementation Improves Microcirculation and Reduces Inflammation in Diabetic Neuropathy Patients.,"We assessed the effect of different doses of vitamin D supplementation on microcirculation, signs and symptoms of peripheral neuropathy and inflammatory markers in patients with type 2 diabetes (T2DM). Sixty-seven patients with T2DM and peripheral neuropathy (34 females) were randomized into two treatment groups: Cholecalciferol 5000 IU and 40,000 IU once/week orally for 24 weeks. Severity of neuropathy (NSS, NDS scores, visual analogue scale), cutaneous microcirculation (MC) parameters and inflammatory markers (ILs, CRP, TNFα) were assessed before and after treatment. Vitamin D deficiency/insufficiency was detected in 78% of the 62 completed subjects. Following treatment with cholecalciferol 40,000 IU/week, a significant decrease in neuropathy severity (NSS,  p  = 0.001; NDS,  p  = 0.001; VAS,  p  = 0.001) and improvement of cutaneous MC were observed ( p  < 0.05). Also, we found a decrease in IL-6 level (2.5 pg/mL vs. 0.6 pg/mL,  p  < 0.001) and an increase in IL-10 level (2.5 pg/mL vs. 4.5 pg/mL,  p  < 0.001) after 24 weeks of vitamin D supplementation in this group. No changes were detected in the cholecalciferol 5000 IU/week group. High-dose cholecalciferol supplementation of 40,000 IU/week for 24 weeks was associated with improvement in clinical manifestation, cutaneous microcirculation and inflammatory markers in patients with T2DM and peripheral neuropathy.",2020,"Severity of neuropathy (NSS, NDS scores, visual analogue scale), cutaneous microcirculation (MC) parameters and inflammatory markers (ILs, CRP, TNFα) were assessed before and after treatment.","['78% of the 62 completed subjects', 'Diabetic Neuropathy Patients', 'Sixty-seven patients with T2DM and peripheral neuropathy (34 females', 'patients with type 2 diabetes (T2DM', 'patients with T2DM and peripheral neuropathy']","['High-Dose Vitamin D Supplementation', 'Cholecalciferol 5000 IU', 'vitamin D supplementation', 'cholecalciferol']","['microcirculation, signs and symptoms of peripheral neuropathy and inflammatory markers', 'Vitamin D deficiency/insufficiency', 'clinical manifestation, cutaneous microcirculation and inflammatory markers', 'neuropathy severity', 'Severity of neuropathy (NSS, NDS scores, visual analogue scale), cutaneous microcirculation (MC) parameters and inflammatory markers (ILs, CRP, TNFα', 'improvement of cutaneous MC', 'IL-10 level', 'IL-6 level']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011882', 'cui_str': 'Diabetic neuropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C4319610', 'cui_str': '5000'}]","[{'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D deficiency'}, {'cui': 'C0231179', 'cui_str': 'Insufficiency'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0194086', 'cui_str': 'Partial nephrectomy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",67.0,0.160226,"Severity of neuropathy (NSS, NDS scores, visual analogue scale), cutaneous microcirculation (MC) parameters and inflammatory markers (ILs, CRP, TNFα) were assessed before and after treatment.","[{'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Karonova', 'Affiliation': 'Almazov National Medical Research Centre, Institute of Endocrinology, 2 Akkuratova str., 197341 St. Petersburg, Russia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Stepanova', 'Affiliation': 'Internal Medicine Department, Pavlov First Saint Petersburg State Medical University, 6-8 L.Tolstoy str., 197022 St. Petersburg, Russia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bystrova', 'Affiliation': 'Almazov National Medical Research Centre, Institute of Endocrinology, 2 Akkuratova str., 197341 St. Petersburg, Russia.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Jude', 'Affiliation': 'Tameside Hospital NHS Foundation Trust, Ashton Under Lyne OL69RW, UK.'}]",Nutrients,['10.3390/nu12092518']
2940,32825337,Enhancing Cognitive Performance of Healthy Czech Seniors through Non-Native Language Learning-A Mixed-Methods Pilot Study.,"The aim of this article is to discuss the effect of learning a non-native language on the enhancement of cognitive performance in healthy native Czech elderly. In addition, special emphasis is put on the qualitative assessment. To do this, 42 Czech cognitively unimpaired seniors were enrolled into the study. These were then divided into an experimental group (i.e., 20 healthy elderly studied English as a non-native language for three months) and a passive control group (22 healthy elderly, who did not undergo any non-native language intervention). The main outcome measures included the Montreal Cognitive Assessment, statistical processing of the data, and a qualitative content analysis. The results indicate that the cognitive performance of the intervention group did not differ from the control group. Therefore, no cognitive enhancement through non-native language learning was achieved. However, the findings of the qualitative analysis show that such non-native language learning with the peers of the same age is especially beneficial for the overall well-being of healthy seniors, especially as far as their social networks are concerned. Furthermore, participant's subjective feelings from their self-reports indicate that foreign language learning also contributes to acquiring new English words and phrases. However, as there are very few empirical studies on this research topic, further research is needed in order to confirm or refute the present research findings on the enhancement of cognitive performance through non-native language learning in healthy seniors.",2020,The results indicate that the cognitive performance of the intervention group did not differ from the control group.,"['42 Czech cognitively unimpaired seniors were enrolled into the study', '20 healthy elderly studied English as a non-native language for three months) and a passive control group (22 healthy elderly, who did not undergo any non-native language intervention', 'Healthy Czech Seniors', 'healthy native Czech elderly', 'healthy seniors']",['learning a non-native language'],"['cognitive performance', 'Montreal Cognitive Assessment, statistical processing of the data, and a qualitative content analysis']","[{'cui': 'C0010871', 'cui_str': 'Czech language'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0023008', 'cui_str': 'Language'}]","[{'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]",20.0,0.0153599,The results indicate that the cognitive performance of the intervention group did not differ from the control group.,"[{'ForeName': 'Blanka', 'Initials': 'B', 'LastName': 'Klimova', 'Affiliation': 'Department of Neurology of the Medical Faculty of Charles, University and University Hospital in Hradec Kralove, Sokolska 581, 500 05 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Slaninova', 'Affiliation': 'Department of Neurology of the Medical Faculty of Charles, University and University Hospital in Hradec Kralove, Sokolska 581, 500 05 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Prazak', 'Affiliation': 'Department of Neurology of the Medical Faculty of Charles, University and University Hospital in Hradec Kralove, Sokolska 581, 500 05 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Jaroslav', 'Initials': 'J', 'LastName': 'Kacetl', 'Affiliation': 'Department of Neurology of the Medical Faculty of Charles, University and University Hospital in Hradec Kralove, Sokolska 581, 500 05 Hradec Kralove, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Valis', 'Affiliation': 'Department of Neurology of the Medical Faculty of Charles, University and University Hospital in Hradec Kralove, Sokolska 581, 500 05 Hradec Kralove, Czech Republic.'}]",Brain sciences,['10.3390/brainsci10090573']
2941,32825677,A Comparison of the Acute Effects of Different Forms of Yoga on Physiological and Psychological Stress: A Pilot Study.,"Yoga is a frequently recommended stress management strategy; however, the acute stress response to varying types of yoga are not fully clear. Thus, the purpose of this study was to compare the acute effects of meditative and power yoga on indices of physiological and psychological stress. In a crossover counterbalanced design, physically active females (n = 13; age = 20.8 yrs ± 0.8, height = 164.5 cm ± 6.1, body mass = 65.0 kg ± 13.8) who did not regularly participate in yoga or mindful training enrolled in this study. Participants completed two visits each, with a standardized instructional-video 30-min yoga session with either A) meditative (Hatha style) yoga or B) power (Vinyasa style) yoga. Prior to and immediately after each yoga bout, psychological stress was assessed using the State-Trait Anxiety Inventory (STAI) questionnaire, and salivary cortisol samples were obtained to measure indices of physiological stress. State anxiety scores were significantly lower following meditative yoga ( p  = 0.047) but were not different following power yoga ( p  = 0.625). Salivary cortisol levels were significantly lower following meditative yoga ( p  = 0.020) but not following power yoga ( p  = 0.242). Results indicate that acute engagement in meditative yoga decreases markers of psychological and physiological stress, while power yoga does not impart a significant stress-relieving benefit. Findings indicate that differing types of yoga may have various stress-relieving capabilities and should be considered by individuals seeking anxiolytic benefits.",2020,State anxiety scores were significantly lower following meditative yoga ( p  = 0.047) but were not different following power yoga ( p  = 0.625).,"['physically active females (n = 13; age = 20.8 yrs ± 0.8, height = 164.5 cm ± 6.1, body mass = 65.0 kg ± 13.8) who did not regularly participate in yoga or mindful training enrolled in this study']","['meditative and power yoga', 'standardized instructional-video 30-min yoga session with either A) meditative (Hatha style) yoga or B) power (Vinyasa style) yoga']","['State-Trait Anxiety Inventory (STAI) questionnaire, and salivary cortisol samples', 'Salivary cortisol levels', 'State anxiety scores', 'psychological and physiological stress']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4517561', 'cui_str': '13.8'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]","[{'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0449430', 'cui_str': 'Physiological stress'}]",13.0,0.0164619,State anxiety scores were significantly lower following meditative yoga ( p  = 0.047) but were not different following power yoga ( p  = 0.625).,"[{'ForeName': 'Mallory', 'Initials': 'M', 'LastName': 'Marshall', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, AL 35229, USA.'}, {'ForeName': 'McKenzie', 'Initials': 'M', 'LastName': 'McClanahan', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, AL 35229, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McArthur Warren', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, AL 35229, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Rogers', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, AL 35229, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Ballmann', 'Affiliation': 'Department of Kinesiology, Samford University, 800 Lakeshore Dr. Birmingham, AL 35229, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17176090']
2942,32825814,Elastic pneumatic tourniquet cuff can reduce postoperative thigh pain after total knee arthroplasty: a prospective randomized trial.,"BACKGROUND


Tourniquet use is associated with complications such as thigh pain, skin problems, and deep vein thrombosis (DVT). This prospective study aimed to evaluate the efficacy and safety of the pneumatic tourniquet system using an elastic cuff and limb occlusion pressure (LOP) in total knee arthroplasty (TKA). The hypothesis of this study was that an elastic cuff tourniquet would result in less postoperative thigh pain after TKA.
METHODS


This prospective randomized controlled trial involved a total of 98 patients who underwent primary TKA. They were randomized into two groups: tourniquet system using an elastic cuff and LOP group (Group E) and tourniquet system using a conventional-cuff and LOP group (Group C). Outcomes including postoperative thigh pain assessed using a visual analog scale (VAS), serum muscle enzymes, recommended tourniquet pressure (RTP), bloodlessness of surgical field, surgical time, incidence of DVT, and the frequency of rescue analgesic use after surgery, were compared between groups.
RESULTS


Patients in Group E experienced significantly less thigh pain compared to those in Group C on postoperative day 4 (P = 0.01) and day 7 (P = 0.04). The difference between RTP and systolic blood pressure was significantly lower in Group E (P = 0.045). One case of thigh DVT was found in Group E, while no such cases were found in Group C. One and two cases of poor bloodless surgical fields were observed in Group E and Group C, respectively. There was no significant difference in surgical time, levels of serum muscle enzymes, and the frequency of rescue analgesic use between the two groups.
CONCLUSIONS


The pneumatic tourniquet system using an elastic cuff and LOP reduced early postoperative thigh pain more effectively than did the tourniquet system using a conventional cuff and LOP.
TRIAL REGISTRATION


# KCT0003149 . Registered August 17, 2018 - Retrospectively registered.",2020,The difference between RTP and systolic blood pressure was significantly lower in Group E (P = 0.045).,"['Registered August 17, 2018 - Retrospectively registered', 'total knee arthroplasty (TKA', 'after total knee arthroplasty', '98 patients who underwent primary TKA']","['tourniquet system using an elastic cuff and LOP group (Group E) and tourniquet system using a conventional-cuff and LOP', 'Elastic pneumatic tourniquet cuff', 'elastic cuff and limb occlusion pressure (LOP', 'pneumatic tourniquet system', 'pneumatic tourniquet system using an elastic cuff and LOP']","['postoperative thigh pain', 'RTP and systolic blood pressure', 'thigh DVT', 'thigh pain', 'surgical time, levels of serum muscle enzymes, and the frequency of rescue analgesic use', 'efficacy and safety', 'bloodless surgical fields', 'postoperative thigh pain assessed using a visual analog scale (VAS), serum muscle enzymes, recommended tourniquet pressure (RTP), bloodlessness of surgical field, surgical time, incidence of DVT, and the frequency of rescue analgesic use after surgery']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441839', 'cui_str': 'Group E'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0180209', 'cui_str': 'Tourniquet cuff'}, {'cui': 'C3880990', 'cui_str': 'Pneumatic tourniquet system'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0241374', 'cui_str': 'Thigh pain'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1141895', 'cui_str': 'Muscle enzyme'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",98.0,0.0518565,The difference between RTP and systolic blood pressure was significantly lower in Group E (P = 0.045).,"[{'ForeName': 'Jae-Young', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Sung Eun', 'Initials': 'SE', 'LastName': 'Kim', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Myung Chul', 'Initials': 'MC', 'LastName': 'Lee', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.'}, {'ForeName': 'Hyuk-Soo', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Department of Orthopedic Surgery, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea. oshawks7@snu.ac.kr.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03579-6']
2943,32825817,The effect of intraoperative goal-directed crystalloid versus colloid administration on perioperative inflammatory markers - a substudy of a randomized controlled trial.,"BACKGROUND


Excessive perioperative fluid administration may result in iatrogenic endothelial dysfunction and tissue edema, transducing inflammatory markers into the bloodstream. Colloids remain longer in the circulation, requiring less volume to reach similar hemodynamic endpoints compared to crystalloids. Thus, we tested the hypothesis that a goal-directed colloid regimen attenuates the inflammatory response compared to a goal-directed crystalloid regime.
METHODS


Patients undergoing moderate- to high-risk open abdominal surgery were randomly assigned to goal-directed lactated Ringer's solution (n = 58) or a hydroxyethyl starch 6% 130/0.4 (n = 62) fluid regimen. Our primary outcome was perioperative levels of pro- and anti-inflammatory cytokines. Secondary outcome was perioperative levels of white blood cell count (WBC), C-reactive protein (CRP), procalcitonin (PCT) and lipopolysaccharide-binding protein (LBP). Measurements were performed preoperatively, immediate postoperatively, on postoperative day one, two and four.
RESULTS


The areas under the curve of Interleukin (IL) 6 (p = 0.60), IL 8 (p = 0.46), IL 10 (p = 0.68) and tumor necrosis factor α (p = 0.47) levels did not differ significantly between the groups. WBC, CRP and PCT values were also comparable. LBP, although significantly higher in the crystalloid group, remained in the normal range. Patients assigned to crystalloids received a median (IQR) amount of 3905 mL (2880-5288) of crystalloid. Patients assigned to colloids received 1557 mL (1207-2116) of crystalloid and 1250 mL (750-1938) of colloid.
CONCLUSION


Cytokine and inflammatory marker levels did not differ between goal-directed crystalloid and colloid administration after moderate to high-risk abdominal surgery.
TRIAL REGISTRATION


ClinicalTrials.gov ( NCT00517127 ). Registered 16th August 2007.",2020,"The areas under the curve of Interleukin (IL) 6 (p = 0.60), IL 8 (p = 0.46), IL 10 (p = 0.68) and tumor necrosis factor α (p = 0.47) levels did not differ significantly between the groups.",['Patients undergoing moderate- to high-risk open abdominal surgery'],"['crystalloid', 'hydroxyethyl starch', 'intraoperative goal-directed crystalloid versus colloid administration', ""goal-directed lactated Ringer's solution""]","['perioperative levels of white blood cell count (WBC), C-reactive protein (CRP), procalcitonin (PCT) and lipopolysaccharide-binding protein (LBP', 'LBP', 'CRP and PCT values', 'tumor necrosis factor α', 'perioperative levels of pro- and anti-inflammatory cytokines']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0198482', 'cui_str': 'Operation on abdominal region'}]","[{'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C0020352', 'cui_str': 'Hetastarch'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0009361', 'cui_str': 'Colloids'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0073386', 'cui_str': 'Ringers Solution'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0072027', 'cui_str': 'Procalcitonin'}, {'cui': 'C0065054', 'cui_str': 'lipopolysaccharide-binding protein'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0032452', 'cui_str': 'Polychlorotriphenyl Compounds'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",,0.436471,"The areas under the curve of Interleukin (IL) 6 (p = 0.60), IL 8 (p = 0.46), IL 10 (p = 0.68) and tumor necrosis factor α (p = 0.47) levels did not differ significantly between the groups.","[{'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Obradovic', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kurz', 'Affiliation': 'Department of Outcomes Research and General Anesthesiology, Anesthesiology Institute, 9500 Euclid Avenue, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kabon', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria. barbara.kabon@meduniwien.ac.at.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Roth', 'Affiliation': 'Department of Anesthesiology and General Intensive Care, Franziskus Hospital, Nikolsdorfergasse 32, 1050, Vienna, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kimberger', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zotti', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Ahamed', 'Initials': 'A', 'LastName': 'Bayoumi', 'Affiliation': 'Department of Gynecology, Klinik Ottakring, Montleartstrasse 37, 1160, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Reiterer', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Stift', 'Affiliation': 'Department of Surgery, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Fleischmann', 'Affiliation': 'Department of Anaesthesia, General Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}]",BMC anesthesiology,['10.1186/s12871-020-01126-3']
2944,32825845,"TOB-STOP-COP (TOBacco STOP in COPd trial): study protocol-a randomized open-label, superiority, multicenter, two-arm intervention study of the effect of ""high-intensity"" vs. ""low-intensity"" smoking cessation intervention in active smokers with chronic obstructive pulmonary disease.","BACKGROUND


Cigarette smoking is the leading cause of chronic obstructive pulmonary disease (COPD), and it contributes to the development of many other serious diseases. Smoking cessation in COPD patients is known to improve survival and reduce the number of hospitalization-requiring acute exacerbations of COPD. However, smoking cessation interventions in these patients have only been successful for approximately 15-20% for consistent smoking abstinence in 12 months. Thus, more effective interventions are needed for this patient group. The aim of this study is to determine whether a high-intensity intervention compared to a low-intensity intervention can increase the proportion of persistent (> 12 months) anamnestic and biochemical smoking cessation in active smokers with COPD.
METHODS


This study is a randomized controlled trial. A total of 600 active smokers with COPD will be randomly assigned 1:1 to either a standard treatment (guideline-based municipal smoking cessation program, ""low intensity"" group) or an intervention (""high-intensity"" group) group, which consists of group sessions, telephone consultations, behavior design, hotline, and ""buddy-matching"" (smoker matched with COPD patient who has ceased smoking). Both groups will receive pharmacological smoking cessation. The primary endpoint is anamnestic and biochemical (cotinine analysis in urine) validated smoking cessation after 12 months.
DISCUSSION


The potential benefit of this project is to improve smoking cessation rates and thereby reduce smoking-related exacerbations of COPD. In addition, the project can potentially benefit from increasing the quality of life and longevity of COPD patients and reducing the risk of other smoking-related diseases.
TRIAL REGISTRATION


ClinicalTrials.gov NCT04088942 . Registered on 13 September 2019.",2020,"The aim of this study is to determine whether a high-intensity intervention compared to a low-intensity intervention can increase the proportion of persistent (> 12 months) anamnestic and biochemical smoking cessation in active smokers with COPD.
","['600 active smokers with COPD', 'active smokers with COPD', 'chronic obstructive pulmonary disease (COPD', 'COPD patients', 'active smokers with chronic obstructive pulmonary disease']","['high-intensity"" vs. ""low-intensity"" smoking cessation intervention', 'standard treatment (guideline-based municipal smoking cessation program, ""low intensity"" group) or an intervention (""high-intensity"" group) group, which consists of group sessions, telephone consultations, behavior design, hotline, and ""buddy-matching"" (smoker matched with COPD patient who has ceased smoking', 'low-intensity intervention', 'high-intensity intervention', 'pharmacological smoking cessation']","['anamnestic and biochemical (cotinine analysis in urine) validated smoking cessation', 'quality of life and longevity', 'smoking cessation rates']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0175745', 'cui_str': 'Telephone consultation'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0020042', 'cui_str': 'Telephone Hotlines'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0010194', 'cui_str': 'Cotinine'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}]",600.0,0.0837198,"The aim of this study is to determine whether a high-intensity intervention compared to a low-intensity intervention can increase the proportion of persistent (> 12 months) anamnestic and biochemical smoking cessation in active smokers with COPD.
","[{'ForeName': 'Mohamad Isam', 'Initials': 'MI', 'LastName': 'Saeed', 'Affiliation': 'Department of Internal Medicine C, Section of Respiratory Medicine, Herlev and Gentofte University Hospital, Hellerup, Denmark. mohamad.isam.saeed.02@regionh.dk.'}, {'ForeName': 'Pradeesh', 'Initials': 'P', 'LastName': 'Sivapalan', 'Affiliation': 'Department of Internal Medicine C, Section of Respiratory Medicine, Herlev and Gentofte University Hospital, Hellerup, Denmark.'}, {'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Eklöf', 'Affiliation': 'Department of Internal Medicine C, Section of Respiratory Medicine, Herlev and Gentofte University Hospital, Hellerup, Denmark.'}, {'ForeName': 'Charlotte Suppli', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Charlotta', 'Initials': 'C', 'LastName': 'Pisinger', 'Affiliation': 'Center for Clinical Research and Prevention, Bispebjerg and Frederiksberg Hospital, Frederiksberg, Denmark.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Lapperre', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Tønnesen', 'Affiliation': 'Department of Respiratory Medicine, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Hoyer', 'Affiliation': 'Department of Internal Medicine C, Section of Respiratory Medicine, Herlev and Gentofte University Hospital, Hellerup, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Janner', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Marie Lavesen', 'Initials': 'ML', 'LastName': 'Karlsson', 'Affiliation': 'Department of Respiratory and Infectious Medicine, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Charlotte Sandau', 'Initials': 'CS', 'LastName': 'Bech', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Marså', 'Affiliation': 'Palliation Unit, Herlev and Gentofte University Hospital, Herlev, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Godtfredsen', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Brøndum', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Munk', 'Affiliation': 'Rygestopcaféen, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Raaschou', 'Affiliation': 'Patient Representative, Hellerup, Denmark.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Browatzski', 'Affiliation': 'Department of Respiratory and Infectious Medicine, Nordsjællands Hospital, Hillerød, Denmark.'}, {'ForeName': 'Pernille', 'Initials': 'P', 'LastName': 'Lütken', 'Affiliation': 'Rygestopkonsulenterne ApS, Hillerød, Denmark.'}, {'ForeName': 'Jens-Ulrik Stæhr', 'Initials': 'JS', 'LastName': 'Jensen', 'Affiliation': 'Department of Internal Medicine C, Section of Respiratory Medicine, Herlev and Gentofte University Hospital, Hellerup, Denmark.'}]",Trials,['10.1186/s13063-020-04653-z']
2945,32826001,The effect of osteopathic manual therapy with breathing retraining on cardiac autonomic measures and breathing symptoms scores: A randomised wait-list controlled trial.,"BACKGROUND


Breathing retraining and manual therapy (MT), delivered independently or together, influence autonomic activity, and improve symptoms in patients with chronic conditions. This study evaluated the effects of breathing retraining and osteopathic MT on cardiac autonomic measures and breathing symptoms during spontaneous breathing in healthy active adults.
METHODS


Participants (n = 18) received breathing retraining and four, weekly manual therapy sessions, randomised to start immediately, or after 6-week delay. Heart-rate (HR) variability was assessed as a 7-day average of waking 6-min electrocardiograms, using time (logarithm of root-mean-square of successive differences; LnRMSSD) and frequency domain (logarithm of high-frequency; LnHF) measures. Recordings were taken before, one week following intervention or delay, and then following the later intervention for those with delayed starts. Changes were compared between those who received and had yet to receive the intervention, and before and after treatment for the whole cohort.
RESULTS


Following the intervention, HR-variability measures increased 4% overall (Effect Sizes: 1.0-1.1) for the whole cohort. Between-group analyses showed that the immediate-start group increased more than the delayed start group: LnRMSSD 0.27 (0.02-0.52; 95%CI) ln.ms, and LnHF 0.41 (-0.01-0.84) ln.ms 2  for immediate start; compared with LnRMSSD -0.09 (-0.29-0.11) ln.ms, and LnHF -0.19 (-0.59-0.22) ln.ms 2  (P = 0.02-0.03 for interaction) for delayed start. Resting HR decreased following intervention in the whole cohort (Effect Size -0.8; P = 0.02).
CONCLUSION


A 6-week osteopathic treatment consisting of breathing retraining and MT is beneficial in raising HR-variability compared to no treatment, and may induce favourable (parasympathetic over sympathetic) autonomic modulation.
TRIAL REGISTRATION


ACTRN12614001119684.",2020,"Resting HR decreased following intervention in the whole cohort (Effect Size -0.8; P = 0.02).
","['Participants (n\xa0=\xa018) received', 'patients with chronic conditions', 'healthy active adults']","['breathing retraining and osteopathic MT', 'breathing retraining and four, weekly manual therapy sessions', 'osteopathic manual therapy with breathing retraining', 'breathing retraining', 'Breathing retraining and manual therapy (MT']","['Resting HR', 'cardiac autonomic measures and breathing symptoms scores', 'HR-variability measures', '7-day average of waking 6-min electrocardiograms, using time (logarithm of root-mean-square of successive differences; LnRMSSD) and frequency domain (logarithm of high-frequency; LnHF) measures', 'cardiac autonomic measures and breathing symptoms', 'Heart-rate (HR) variability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0419203', 'cui_str': 'Osteopathy'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0424805', 'cui_str': 'Breath symptom'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0562482,"Resting HR decreased following intervention in the whole cohort (Effect Size -0.8; P = 0.02).
","[{'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Benjamin', 'Affiliation': 'Osteopathy, Unitec Institute of Technology, Auckland, New Zealand.'}, {'ForeName': 'R W', 'Initials': 'RW', 'LastName': 'Moran', 'Affiliation': 'Osteopathy, Unitec Institute of Technology, Auckland, New Zealand.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Plews', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Kilding', 'Affiliation': 'Sports Performance Research Institute New Zealand (SPRINZ), Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Barnett', 'Affiliation': 'Osteopathy, Unitec Institute of Technology, Auckland, New Zealand.'}, {'ForeName': 'W J', 'Initials': 'WJ', 'LastName': 'Verhoeff', 'Affiliation': 'Sport, Unitec Institute of Technology, Auckland, New Zealand.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Bacon', 'Affiliation': 'Osteopathy, Unitec Institute of Technology, Auckland, New Zealand; School of Nursing, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand. Electronic address: c.bacon@auckland.ac.nz.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.014']
2946,32826003,The immediate effect of whole body vibration training on the electromyographic activity of contralateral hand muscles; a randomized controlled trial.,"Whole Body Vibration (WBV) has been used as a useful adjunct to improve the neuromuscular function of the upper limb. Cross-transfer of strength plays an important role in rehabilitation of unilateral injuries. The present research intended to evaluate the acute effect of low frequency WBV training on cross-transfer of electromyographic activity and hand muscles strength when the measurement was performed on the contralateral limb. This was a randomized crossover trial conducted in a clinical biomechanics laboratory. Twenty-eight healthy participants aging between 20 and 35 years were included who were involved in two sessions with two weeks of rest. The participants were randomly assigned in two groups as follows: 1) active WBV/sham WBV; 2) sham WBV/active WBV. The participants were asked to stand on the vibrating plate and pull its belt in a vibrating mode using their dominant hand. Then, after a two-week rest, they performed the same task in the vibrating mode (35 Hz). Grip strength and electromyography (root mean square) in flexor digitorum profundus (FDP), flexor digitorum superficialis (FDS), extensor carpi radialis (ECR), and extensor carpi ulnaris (ECU) muscles of the contralateral limb were measured before and after exercise in both phases. No significant change was observed in the electrical activity of FDP, FDS, ECR, ECU muscles, and hands' grip strength of the contralateral limb (P > 0.05). WBV (35 Hz) was not able to augment cross-transfer in electromyographic activity and neuromuscular performance of the upper limb. Further studies would help to explore these results for several sessions of WBV on cross-transfer of training.",2020,WBV (35 Hz) was not able to augment cross-transfer in electromyographic activity and neuromuscular performance of the upper limb.,['Twenty-eight healthy participants aging between 20 and 35 years were included who were involved in two sessions with two weeks of rest'],"['low frequency WBV training', 'active WBV/sham WBV; 2) sham WBV/active WBV', 'whole body vibration training', 'Whole Body Vibration (WBV']","['electromyographic activity of contralateral hand muscles', 'Grip strength and electromyography (root mean square) in flexor digitorum profundus (FDP), flexor digitorum superficialis (FDS), extensor carpi radialis (ECR), and extensor carpi ulnaris (ECU) muscles of the contralateral limb', ""electrical activity of FDP, FDS, ECR, ECU muscles, and hands' grip strength of the contralateral limb"", 'electromyographic activity and hand muscles strength']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0581668', 'cui_str': 'Muscle structure of hand'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0224261', 'cui_str': 'Structure of flexor digitorum profundus muscle of hand'}, {'cui': 'C0224258', 'cui_str': 'Structure of flexor digitorum superficialis muscle of hand'}, {'cui': 'C0224272', 'cui_str': 'Extensor carpi ulnaris muscle structure'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0060663', 'cui_str': 'formycin diphosphate'}, {'cui': 'C0013593', 'cui_str': 'Ecuador'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0018563', 'cui_str': 'Hand'}]",28.0,0.0166128,WBV (35 Hz) was not able to augment cross-transfer in electromyographic activity and neuromuscular performance of the upper limb.,"[{'ForeName': 'Cyrus', 'Initials': 'C', 'LastName': 'Taghizadeh Delkhoush', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Rasool', 'Initials': 'R', 'LastName': 'Bagheri', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: Rasool.Bagheri@Semums.ac.ir.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Mashhadi Hashemi', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Fatemy', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Rozita', 'Initials': 'R', 'LastName': 'Hedayati', 'Affiliation': 'Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.027']
2947,32826008,"Effect of adding stretching to standardized procedures on cervical range of motion, pain, and disability in patients with non-specific mechanical neck pain: A randomized clinical trial.","OBJECTIVE


to investigate the benefit of adding stretching exercises to cervical joint mobilization and active rotation exercises for patients with non-specific mechanical neck pain.
METHODS


Thirty-eight subjects with non-specific mechanical neck pain were randomly assigned to a standard procedure group (passive cervical mobilization and active cervical rotation range of motion exercise) or a combined procedure (passive cervical mobilization, active cervical rotation range of motion exercises, and stretching procedures). Mixed factorial analysis of variance was used to compare changes between groups over time in active cervical range of motion, Numeric Pain Rating Scale, Neck Disability Index, Global Rating of Change, and Pressure Pain Threshold.
RESULTS


There was a significant change in mean active range of motion in all directions, Pressure Pain Threshold, perceived pain, disability levels, and global rating of change over time (p < 0.001). There was a significant group by time interaction in mean active range of motion during extension (p = 0.01), right rotation (p = 0.004), right and left lateral flexion (p = 0.05, and p = 0.02 respectively). However, there was no significant group by time interaction in mean active range of motion during flexion, left rotation, pain intensity (p = 0.09), right and left pressure pain threshold (p = 0.30, 0.47, respectively), and disability (p = 0.07).
CONCLUSIONS


Both study groups improved significantly in all subjective and objective outcome measures. However, data from this study suggest that adding stretching to the standard procedures may be more effective than the standard procedure alone at improving cervical extension, right rotation, and lateral flexion active range of motion, but not pain and disability.",2020,"There was a significant change in mean active range of motion in all directions, Pressure Pain Threshold, perceived pain, disability levels, and global rating of change over time (p < 0.001).","['Thirty-eight subjects with non-specific mechanical neck pain', 'patients with non-specific mechanical neck pain']","['stretching exercises to cervical joint mobilization and active rotation exercises', 'adding stretching to standardized procedures', 'standard procedure group (passive cervical mobilization and active cervical rotation range of motion exercise) or a combined procedure (passive cervical mobilization, active cervical rotation range of motion exercises, and stretching procedures']","['time interaction in mean active range of motion during extension', 'right and left pressure pain threshold', 'disability', 'right rotation', 'active cervical range of motion, Numeric Pain Rating Scale, Neck Disability Index, Global Rating of Change, and Pressure Pain Threshold', 'time interaction in mean active range of motion during flexion, left rotation, pain intensity', 'mean active range of motion in all directions, Pressure Pain Threshold, perceived pain, disability levels, and global rating of change over time', 'cervical range of motion, pain, and disability', 'cervical extension, right rotation, and lateral flexion active range of motion', 'right and left lateral flexion']","[{'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231588', 'cui_str': 'Physiatric mobilization of joint'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0150220', 'cui_str': 'Range of motion exercise'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439791', 'cui_str': 'Lateral flexion'}]",38.0,0.127046,"There was a significant change in mean active range of motion in all directions, Pressure Pain Threshold, perceived pain, disability levels, and global rating of change over time (p < 0.001).","[{'ForeName': 'Saad', 'Initials': 'S', 'LastName': 'Alfawaz', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, CA, USA; Department of Physical Therapy, College of Medical Rehabilitation Sciences, King Abdulaziz University, Saudi Arabia.'}, {'ForeName': 'Everett', 'Initials': 'E', 'LastName': 'Lohman', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Alameri', 'Affiliation': 'Department of Physical Therapy, School of Allied Health Professions, Loma Linda University, Loma Linda, CA, USA; Brockton Physical Therapy, Riverside, CA, USA.'}, {'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Daher', 'Affiliation': 'Department of Allied Health Studies, School of Allied Health Professions, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Hatem', 'Initials': 'H', 'LastName': 'Jaber', 'Affiliation': 'Department of Allied Health Studies, School of Allied Health Professions, Loma Linda University, Loma Linda, CA, USA; Department of Physical Therapy, School of Rehabilitative Sciences, University of St. Augustine for Health Sciences, Austin, TX, USA. Electronic address: Hjaber@llu.edu.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.020']
2948,32826010,Short-term effect of muscle energy technique and mechanical diagnosis and therapy in sacroiliac joint dysfunction: A pilot randomized clinical trial.,"INTRODUCTION


Sacroiliac joint dysfunction (SIJD) is a prominent source of pain in low back pain (LBP) patients. Tenderness inferior to the posterior superior iliac spine (PSIS) is an important sign presented in SIJD. Techniques including muscle energy technique (MET) and mechanical diagnosis and therapy (MDT) have shown benefits in SIJD. However, the effects of these treatments on tenderness and pain around the PSIS are yet to be determined.
AIM


Compare and examine the preliminary short-term effect of MET and MDT on tenderness and pain around the PSIS in SIJD.
METHODS


Twenty patients, aged between 20 and 65 years and diagnosed with unilateral, sub-acute, or chronic SIJD, were screened for the inclusion criteria and were randomly allocated to the MET or the MDT group. Both the groups received treatment for four sessions over one week. Pain pressure threshold (PPT) and visual analogue scale (VAS) were determined by a blinded assessor on pre- and post-treatment basis.
RESULTS


Although no significant differences were observed following the treatment between the groups, some statistically significant (p < 0.05) improvements were observed within each of the groups. No drop-outs and no adverse events were reported.
CONCLUSION


The findings of the study suggest that both interventions may be equally effective in reducing symptoms around the PSIS. However, due to the small sample size, the results need to be interpreted cautiously. Future studies on larger sample size and long-term follow up are warranted.",2020,"Although no significant differences were observed following the treatment between the groups, some statistically significant (p < 0.05) improvements were observed within each of the groups.","['Twenty patients, aged between 20 and 65 years and diagnosed with unilateral, sub-acute, or chronic SIJD, were screened for the inclusion criteria', 'low back pain (LBP) patients', 'sacroiliac joint dysfunction']","['MET and MDT', 'muscle energy technique (MET) and mechanical diagnosis and therapy (MDT', 'muscle energy technique and mechanical diagnosis and therapy', 'posterior superior iliac spine (PSIS']","['tenderness and pain', 'drop-outs and no adverse events', 'Pain pressure threshold (PPT) and visual analogue scale (VAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0036036', 'cui_str': 'Sacroiliac joint structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C1562466', 'cui_str': 'Muscle energy technique'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0223646', 'cui_str': 'Structure of posterior superior iliac spine'}]","[{'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0439787', 'cui_str': 'Out'}, {'cui': 'C1963761', 'cui_str': 'No adverse event'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",,0.0363968,"Although no significant differences were observed following the treatment between the groups, some statistically significant (p < 0.05) improvements were observed within each of the groups.","[{'ForeName': 'Saumya', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Nitte Institute of Physiotherapy, Nitte (deemed to be) University, Mangalore, Karnataka, 575018, India. Electronic address: saumyasri2000@nitte.edu.in.'}, {'ForeName': 'Dhanesh', 'Initials': 'D', 'LastName': 'Kumar K U', 'Affiliation': 'Nitte Institute of Physiotherapy, Nitte (deemed to be) University, Mangalore, Karnataka, 575018, India.'}, {'ForeName': 'Harramb', 'Initials': 'H', 'LastName': 'Mittal', 'Affiliation': 'Department of Trauma and Orthopedics, Kanachur Institute of Medical Sciences, Mangalore, Karnataka, India. Electronic address: dr_harramb@yahoo.co.in.'}, {'ForeName': 'Snehil', 'Initials': 'S', 'LastName': 'Dixit', 'Affiliation': 'Department of Medical Rehabilitation Sciences, King Khalid University, Saudi Arabia.'}, {'ForeName': 'Aishwarya', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Nitte Institute of Physiotherapy, Nitte (deemed to be) University, Mangalore, Karnataka, 575018, India.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.017']
2949,32825990,Osteopathic treatment of patients with shoulder pain. A pragmatic randomized controlled trial.,"BACKGROUND


Shoulder complaints are common in the general population. Typically, the diagnosis of a specific pathology is lacking. The objective of this trial was to evaluate the effectiveness of an osteopathic treatment in patients suffering from shoulder pain.
METHODS


A pragmatic randomized controlled trial was conducted in patients with a history of shoulder pain of 6 weeks to 12 months, and a pain intensity level of at least 40% on the visual analogue scale (VAS). Participants were identified from the general population in Germany and allocated by means of external randomization to an intervention group or a control group. Patients in the intervention group received five osteopathic treatments at intervals of two weeks. Treatment was custom tailored and based on osteopathic principles. Controls received their osteopathic treatment after an 8-week untreated waiting period. Primary outcome parameters were pain intensity and frequency, measured by VAS and Likert Scales. Secondary outcome parameters were shoulder specific pain and disability (Shoulder Pain and Disability Index, SPADI), and quality of life (SF-36).
RESULTS


A total of 70 patients aged 25-70 years (average age 45.6 ± 13.4 years) were included, 36 in the intervention group and 34 in the control group. The inter-group comparison of changes revealed clinically relevant improvements in favor of the intervention group for the main outcome parameters maximal pain intensity (VAS: between group difference of means 41.5; 95% CI: 34.6 to 48.3; p < 0.005) and average pain intensity (VAS: between group difference of means 40.4; 95% CI: 33.2 to 47.5; p < 0.005). The proportion of participants with a low frequency of pain increased in the osteopathic group only (from 7 to 34 vs. 9 to 6 in the control group, p = 0.006), and the number of patients with a high frequency decreased in the osteopathic group only (from 29 to 2 vs. 25 to 28, p < 0.0005). Shoulder specific pain and disability also improved. The follow-up assessment in the intervention group showed further improvements.
CONCLUSIONS


Five osteopathic treatments over a period of eight weeks led to statistically significant and clinically relevant positive changes of pain and disability in patients suffering from shoulder pain.",2020,The inter-group comparison of changes revealed clinically relevant improvements in favor of the intervention group for the main outcome parameters maximal pain intensity (VAS: between group difference of means 41.5; 95% CI: 34.6 to 48.3; p < 0.005) and average pain intensity (VAS: between group difference of means 40.4; 95% CI: 33.2 to 47.5; p < 0.005).,"['patients suffering from shoulder pain', '70 patients aged 25-70 years (average age 45.6\xa0±\xa013.4 years) were included, 36 in the intervention group and 34 in the control group', 'patients with shoulder pain', 'patients with a history of shoulder pain of 6 weeks to 12 months, and a pain intensity level of at least 40% on the visual analogue scale (VAS']","['control group', 'osteopathic treatment']","['average pain intensity (VAS', 'pain and disability', 'shoulder specific pain and disability (Shoulder Pain and Disability Index, SPADI), and quality of life (SF-36', 'maximal pain intensity (VAS', 'Shoulder specific pain and disability', 'pain intensity and frequency, measured by VAS and Likert Scales', 'low frequency of pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0419203', 'cui_str': 'Osteopathy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}]",70.0,0.16424,The inter-group comparison of changes revealed clinically relevant improvements in favor of the intervention group for the main outcome parameters maximal pain intensity (VAS: between group difference of means 41.5; 95% CI: 34.6 to 48.3; p < 0.005) and average pain intensity (VAS: between group difference of means 40.4; 95% CI: 33.2 to 47.5; p < 0.005).,"[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schwerla', 'Affiliation': 'German Academy of Osteopathy, Research Commission, Gauting, Germany. Electronic address: f.schwerla@german-afo.de.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Hinse', 'Affiliation': 'STILL Academy, Mühlheim, Germany. Electronic address: torsten.hinse@gmx.de.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Klosterkamp', 'Affiliation': 'STILL Academy, Mühlheim, Germany. Electronic address: markus.klosterkamp@t-online.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schmitt', 'Affiliation': 'STILL Academy, Mühlheim, Germany. Electronic address: osteopathie-schmitt@web.de.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Rütz', 'Affiliation': 'German Academy of Osteopathy, Research Commission, Gauting, Germany. Electronic address: m.ruetz@osteopathie-akademie.de.'}, {'ForeName': 'Karl-Ludwig', 'Initials': 'KL', 'LastName': 'Resch', 'Affiliation': 'German Institute for Health Research (DIG), Bad Elster, Germany. Electronic address: K.L.Resch@t-online.de.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.009']
2950,32825994,Neuromuscular activation analysis of the trunk muscles during hippotherapy sessions.,"INTRODUCTION


Hippotherapy allows the development of affective, sensory, motor, and cognitive areas, besides providing the practitioner with several movements and stimuli necessary for therapeutic progress. However, there is a limited amount of scientific evidence regarding the suitability of the mount material, mount type, and hippotherapy session duration, as well as regarding the activation of specific muscle groups during the practice and its applicability to activities of daily living.
OBJECTIVE


This study aimed to study the neuromuscular activation behavior of the iliocostalis, longissimus, multifidus, and upper trapezius muscles of children during four hippotherapy session time points using a functional task. It also compared two different mount materials for riding.
METHODOLOGY


A total of 30 children were randomly assigned to one of three groups: Saddle Hippotherapy Group, Blanket Hippotherapy Group, and Control Group. Data were collected with an electromyograph in a functional task that comprised trunk movements to pick up an object. Assessments took place at four times during the session.
RESULTS


There was a significant increase in the neuromuscular activation of the iliocostalis, longissimus, and multifidus muscles after a 30-min session. The trapezius muscle showed increased neuromuscular activation after only 10 min. It continued to increase (but without a statistical difference) after and 20 and 30 min.
CONCLUSION


Hippotherapy promoted neuromuscular activation of the trunk muscles in children, assessed through a functional task, and was influenced by both session time and mount material. Specifically, the greater neuromuscular performance occurred when an exercise was performed using saddle and stirrup and lasted 30 min.",2020,"There was a significant increase in the neuromuscular activation of the iliocostalis, longissimus, and multifidus muscles after a 30-min session.","['30 children', 'children during four hippotherapy session time points using a functional task']","['Saddle Hippotherapy Group, Blanket Hippotherapy Group, and Control Group', 'electromyograph', 'Hippotherapy']","['neuromuscular activation', 'neuromuscular activation of the iliocostalis, longissimus, and multifidus muscles', 'neuromuscular performance']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]","[{'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0179330', 'cui_str': 'Blanket'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0180677', 'cui_str': 'Electromyograph'}]","[{'cui': 'C0224306', 'cui_str': 'Structure of longissimus muscle'}, {'cui': 'C0224319', 'cui_str': 'Structure of multifidus muscle'}]",30.0,0.0185116,"There was a significant increase in the neuromuscular activation of the iliocostalis, longissimus, and multifidus muscles after a 30-min session.","[{'ForeName': 'Júlio Ribeiro', 'Initials': 'JR', 'LastName': 'Bravo Gonçalves Junior', 'Affiliation': 'Federal University of Viçosa, Brazil. Electronic address: julioebravo@yahoo.com.br.'}, {'ForeName': 'André Gustavo', 'Initials': 'AG', 'LastName': 'Fernandes de Oliveira', 'Affiliation': 'Federal University of Juiz de Fora, Brazil.'}, {'ForeName': 'Silvia Almeida', 'Initials': 'SA', 'LastName': 'Cardoso', 'Affiliation': 'Federal University of Viçosa, Brazil.'}, {'ForeName': 'Kamila Gabriela', 'Initials': 'KG', 'LastName': 'Jacob', 'Affiliation': 'Dinâmica of Vale of Piranga of Ponte Nova University, Brazil.'}, {'ForeName': 'Lucas Vilas', 'Initials': 'LV', 'LastName': 'Boas Magalhães', 'Affiliation': 'Federal University of Viçosa, Brazil.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.029']
2951,32825996,Effects of dry needling on symptomatic hallux valgus: A randomized single blind clinical trial.,"OBJECTIVES


The purpose of the present study was to determine the short and medium effects of dry needling (DN) on myofascial trigger points (MTrPs) in individuals with symptomatic hallux valgus (SHV).
METHODS


A total of 30 female volunteers, aged 25-60, with hallux valgus (HV) were randomly divided into two groups: DN group (n = 15) and control group (n = 15) who received sham dry needling. The outcome measures were pain intensity (Visual Analogue Scale, VAS), Foot Function Index (FFI), hallux valgus angle (HVA), and first metatarsophalangeal joint radiography.
RESULTS


At the end of the intervention, the HVA showed a significant decrease in the case group (P < 0.001); however, statistically no significant difference was found in the pain intensity and foot function between the two groups (P > 0.05). These findings were maintained for a week and a month during follow-ups.
CONCLUSION


According to the findings, dry needling can be recommended for improving first metatarsophalangeal joint alignment in the mild to moderate SHV individuals.",2020,"At the end of the intervention, the HVA showed a significant decrease in the case group (P < 0.001); however, statistically no significant difference was found in the pain intensity and foot function between the two groups (P > 0.05).","['30 female volunteers, aged 25-60, with hallux valgus (HV', 'symptomatic hallux valgus', 'individuals with symptomatic hallux valgus (SHV']","['dry needling', 'DN group (n\xa0=\xa015) and control group (n\xa0=\xa015) who received sham dry needling', 'dry needling (DN']","['pain intensity and foot function', 'myofascial trigger points (MTrPs', 'pain intensity (Visual Analogue Scale, VAS), Foot Function Index (FFI), hallux valgus angle (HVA), and first metatarsophalangeal joint radiography']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0018536', 'cui_str': 'Hallux valgus'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index'}, {'cui': 'C0018536', 'cui_str': 'Hallux valgus'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0025589', 'cui_str': 'Metatarsophalangeal joint structure'}, {'cui': 'C0034571', 'cui_str': 'radiography'}]",30.0,0.0274087,"At the end of the intervention, the HVA showed a significant decrease in the case group (P < 0.001); however, statistically no significant difference was found in the pain intensity and foot function between the two groups (P > 0.05).","[{'ForeName': 'Aliye Sadat', 'Initials': 'AS', 'LastName': 'Kharazmi', 'Affiliation': 'School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farshad', 'Initials': 'F', 'LastName': 'Okhovatian', 'Affiliation': 'Physiotherapy Research Center, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: farshadokhovatian1965@gmail.com.'}, {'ForeName': 'Alireza Akbarzadeh', 'Initials': 'AA', 'LastName': 'Baghban', 'Affiliation': 'Proteomics Research Center, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'Department of Physiotherapy, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran.'}, {'ForeName': 'Marzieh Mohammadi', 'Initials': 'MM', 'LastName': 'Kojidi', 'Affiliation': 'Physiotherapy Research Center, School of Rehabilitation, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hadi', 'Initials': 'H', 'LastName': 'Azimi', 'Affiliation': 'Department of English Language Teaching, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.016']
2952,32826000,"The effectiveness of biomechanical taping and Kinesiotaping on shoulder pain, active range of motion and function of participants with Trapezius Myalgia: A randomized controlled trial.","BACKGROUND


Trapezius Myalgia (TM) is characterized by shoulder pain and dysfunction. Kinesio Taping is commonly used in symptom management of TM. Biomechanical Taping (BMT), a novel intervention, may provide equally effective management.
OBJECTIVES


This paper reports on the effectiveness of Biomechanical Taping compared with Kinesio Taping in improving shoulder pain, active range of motion (AROM), and function.
METHODS


Two groups of participants with TM were recruited through simple random sampling of participants from nine call centers and purposively-sampled participants from one fast-food chain and one community based rehabilitation center in Manila, Philippines. Participants were randomly allocated to either Kinesio Taping or biomechanical taping group in a double-blind clinical trial. Irrespective of the type of taping, participants performed gentle passive stretching of upper trapezius for six times each held for 30 s on Days 1, 3, and 5. On Days 2 and 4, participants performed gentle passive stretch of upper trapezius three times a day. Pre- and post-intervention measures were taken of Visual Analogue Scale for pain intensity, AROM for shoulder movement, and Disability of Arm, Shoulder, and Hand for function.
RESULTS


Of 68 participants, 62 had shoulder symptoms secondary to TM. Similar significant within group improvements were found for Visual Analogue Scale scores, and Disability of Arm, Shoulder and Hand for biomechanical taping and Kinesio Taping interventions when comparing between group results (p < 0.05).
CONCLUSION


Biomechanical Taping appears to be as effective as Kinesio Taping in the short term in decreasing pain and improving function of individuals with TM. Both taping techniques did not restrict shoulder AROM of included participants.
MESH TERMS


Athletic Tape, Myalgia, Pain Measurements, Shoulder Pain NON-MESH TERMS: Biomechanical Taping Technique.",2020,"Similar significant within group improvements were found for Visual Analogue Scale scores, and Disability of Arm, Shoulder and Hand for biomechanical taping and Kinesio Taping interventions when comparing between group results (p < 0.05).
","['Two groups of participants with TM were recruited through simple random sampling of participants from nine call centers and purposively-sampled participants from one fast-food chain and one community based rehabilitation center in Manila, Philippines', '68 participants, 62 had shoulder symptoms secondary to TM', 'participants with Trapezius Myalgia']","['Biomechanical Taping', 'MESH', 'Kinesio Taping or biomechanical taping', 'Biomechanical Taping (BMT', 'biomechanical taping and Kinesiotaping', 'Biomechanical Taping Technique', 'Shoulder Pain NON-MESH TERMS', 'Kinesio Taping']","['Visual Analogue Scale for pain intensity, AROM for shoulder movement, and Disability of Arm, Shoulder, and Hand for function', 'Athletic Tape, Myalgia, Pain Measurements', 'shoulder pain, active range of motion and function', 'shoulder pain, active range of motion (AROM), and function', 'Visual Analogue Scale scores, and Disability of Arm, Shoulder and Hand for biomechanical taping and Kinesio Taping interventions']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C4277665', 'cui_str': 'Call Center'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0344355', 'cui_str': 'Convenience food'}, {'cui': 'C0337112', 'cui_str': 'Chain'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0427048', 'cui_str': 'Movement of shoulder'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C2350263', 'cui_str': 'Orthotic Tape'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",68.0,0.164617,"Similar significant within group improvements were found for Visual Analogue Scale scores, and Disability of Arm, Shoulder and Hand for biomechanical taping and Kinesio Taping interventions when comparing between group results (p < 0.05).
","[{'ForeName': 'Valentin C', 'Initials': 'VC', 'LastName': 'Dones Iii', 'Affiliation': 'College of Rehabilitation Sciences, University of Santo Tomas, Philippines; Center for Health Research and Movement Science, College of Rehabilitation Sciences, University of Santo Tomas, Philippines. Electronic address: vcdones@ust.edu.ph.'}, {'ForeName': 'Jocel M', 'Initials': 'JM', 'LastName': 'Regino', 'Affiliation': 'College of Rehabilitation Sciences, University of Santo Tomas, Philippines; Center for Health Research and Movement Science, College of Rehabilitation Sciences, University of Santo Tomas, Philippines.'}, {'ForeName': 'Nicole Trizia S', 'Initials': 'NTS', 'LastName': 'Esplana', 'Affiliation': 'College of Rehabilitation Sciences, University of Santo Tomas, Philippines.'}, {'ForeName': 'Ivan Rafael V', 'Initials': 'IRV', 'LastName': 'Rivera', 'Affiliation': 'College of Rehabilitation Sciences, University of Santo Tomas, Philippines.'}, {'ForeName': 'Melissa Kaye R', 'Initials': 'MKR', 'LastName': 'Tomas', 'Affiliation': 'College of Rehabilitation Sciences, University of Santo Tomas, Philippines.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.004']
2953,32826011,"The immediate effect of lumbopelvic manipulation on knee pain, knee position sense, and balance in patients with patellofemoral pain: A randomized controlled trial.","BACKGROUND


Patellofemoral pain (PFP) is a common musculoskeletal disorder. Quadriceps and core muscle neuromuscular control impairments are frequently associated with PFP. Lumbopelvic manipulation (LPM) has been shown to improve quadriceps and core muscle activation and decrease their inhibition, but changes in balance and knee joint position sense (JPS) after this intervention remain unknown.
OBJECTIVE


To determine whether LPM decreases knee pain and JPS error and increases balance performance in patients with PFP.
DESIGN


Randomized controlled trial.
SETTING


Biomechanics laboratory at a rehabilitation science research center.
METHODS


Forty-four patients with PFP participated in this study that randomly divided into two equal groups. One group received LPM and the other received sham LPM (positioning with no thrust) in a single session. At baseline and immediately after the intervention, the outcomes of pain using a visual analog scale, balance using the modified star excursion balance test (mSEBT), and JPS at 20° and 60° of knee flexion using a Biodex dynamometer.
RESULTS


There was a statistically significant improvement in pain, balance control (anterior direction) and JPS in the LPM group immediately after the intervention. In addition, we observed significant differences between groups in pain, balance control (anterior direction) and JPS at 60° of knee flexion immediately after the intervention.
CONCLUSION


A single session of LPM immediately improved balance control, knee JPS, and pain in patients diagnosed with PFP.
CLINICAL REHABILITATION IMPACT


Findings suggest that LPM may be used as a therapeutic tool for immediate improvement of symptoms of PFP. However, more research is needed to determine long term results.",2020,"There was a statistically significant improvement in pain, balance control (anterior direction) and JPS in the LPM group immediately after the intervention.","['patients with patellofemoral pain', 'patients diagnosed with PFP', 'patients with PFP', 'Biomechanics laboratory at a rehabilitation science research center', 'Forty-four patients with PFP participated']","['Lumbopelvic manipulation (LPM', 'LPM', 'sham LPM', 'lumbopelvic manipulation']","['knee pain, knee position sense, and balance', 'balance performance', 'pain, balance control (anterior direction) and JPS', 'pain using a visual analog scale, balance using the modified star excursion balance test (mSEBT), and JPS at 20° and 60° of knee flexion using a Biodex dynamometer', 'balance control, knee JPS, and pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0234219', 'cui_str': 'Postural sense'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0423561', 'cui_str': 'Joint position sense'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}]",44.0,0.0687298,"There was a statistically significant improvement in pain, balance control (anterior direction) and JPS in the LPM group immediately after the intervention.","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Motealleh', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Rehabilitation Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Barzegar', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Abbasi', 'Affiliation': 'Physical Therapy Department, School of Rehabilitation Sciences, Shiraz University of Medical Sciences, Shiraz, Iran; Rehabilitation Sciences Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: leabbasi@sums.ac.ir.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.01.006']
2954,32826014,The effect of Kinesio-tape® on pain and vertical jump performance in active individuals with patellar tendinopathy.,"BACKGROUND


Patellar tendinopathy is a common inflammatory condition in athletes who undergo large volumes of running and jumping. Kinesio-tape® (KT) is proposed to provide pain relief; however, its effect has not been examined on patellar tendinopathy.
OBJECTIVE


To examine the effects of KT on pain modulation for active individuals with patellar tendinopathy during functional activities.
METHODS


Thirteen symptomatic knees from seven college-aged females (6 bilateral; 1 unilateral) were included. Participants underwent three data collection sessions with KT, sham, and no tape (NT) in a randomized order. During the session, participants performed a maximum vertical jump, single-leg squats and isometric knee extension. The KT intervention was applied according to the KT manual and the sham utilized the same pattern without tension. Pain level was evaluated using the numeric pain scale before, during and after each activity. Function was assessed as maximum vertical jump height and maximum isometric strength. A separate repeated measures ANOVA was used to compare each dependent variable (pain level, vertical jump height, and isometric strength) among the conditions.
RESULTS


Reported pain scores were significantly lower (p = 0.05) during the maximal vertical jump test for KT (3.38 ± 1.26) compared to NT (4.54 ± 2.22). Significantly lower jump heights were found under KT (17.73 ± 3.06in) during the maximum vertical jump test compared to sham (18.65 ± 2.17in, p = 0.000) and NT (18.18 ± 2.93in, p = 0.008).
CONCLUSIONS


The use of the KT tape with a tendon corrective strip and muscle facilitative strip was effective for decreasing pain associated with patellar tendinopathy during jump landing but led to decreased maximum jump height.
CLINICAL TRIAL IDENTIFIER


NCT04153877.",2020,"RESULTS


Reported pain scores were significantly lower (p = 0.05) during the maximal vertical jump test for KT (3.38 ± 1.26) compared to NT (4.54 ± 2.22).","['athletes who undergo large volumes of running and jumping', 'Thirteen symptomatic knees from seven college-aged females (6 bilateral; 1 unilateral) were included', 'active individuals with patellar tendinopathy', 'active individuals with patellar tendinopathy during functional activities']","['KT', 'Kinesio-tape®', 'KT tape with a tendon corrective strip and muscle facilitative strip', 'KT, sham, and no tape (NT', 'KT intervention', 'Kinesio-tape® (KT']","['pain scores', 'pain modulation', 'variable (pain level, vertical jump height, and isometric strength', 'pain and vertical jump performance', 'numeric pain scale', 'maximum vertical jump height and maximum isometric strength', 'Pain level', 'jump heights']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]","[{'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",13.0,0.0538643,"RESULTS


Reported pain scores were significantly lower (p = 0.05) during the maximal vertical jump test for KT (3.38 ± 1.26) compared to NT (4.54 ± 2.22).","[{'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'Department of Kinesiology and Rehabilitation Science, University of Hawaii at Manoa, 1337 Lower Campus Road, PE/A Complex, Honolulu, HI, 96822, USA. Electronic address: ktamura@hawaii.edu.'}, {'ForeName': 'Portia B', 'Initials': 'PB', 'LastName': 'Resnick', 'Affiliation': 'Department of Kinesiology, California State University, Long Beach, 1250 Bellflower Boulevard, Long Beach, CA, 90804, USA. Electronic address: portia.resnick@csulb.edu.'}, {'ForeName': 'Bruce P', 'Initials': 'BP', 'LastName': 'Hamelin', 'Affiliation': 'Department of Athletics, Florida Atlantic University, 777 Glades Rd, Boca Raton, FL, 33431, USA. Electronic address: bhamelin@fau.edu.'}, {'ForeName': 'Yukiya', 'Initials': 'Y', 'LastName': 'Oba', 'Affiliation': 'Department of Kinesiology and Rehabilitation Science, University of Hawaii at Manoa, 1337 Lower Campus Road, PE/A Complex, Honolulu, HI, 96822, USA. Electronic address: yukiya@hawaii.edu.'}, {'ForeName': 'Ronald K', 'Initials': 'RK', 'LastName': 'Hetzler', 'Affiliation': 'Department of Kinesiology and Rehabilitation Science, University of Hawaii at Manoa, 1337 Lower Campus Road, PE/A Complex, Honolulu, HI, 96822, USA. Electronic address: hetzler@hawaii.edu.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Stickley', 'Affiliation': 'Department of Kinesiology and Rehabilitation Science, University of Hawaii at Manoa, 1337 Lower Campus Road, PE/A Complex, Honolulu, HI, 96822, USA. Electronic address: cstickle@hawaii.edu.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.005']
2955,32826015,The immediate effect of IASTM vs. Vibration vs. Light Hand Massage on knee angle repositioning accuracy and hamstrings flexibility: A pilot study.,"INTRODUCTION


The effectiveness of novel soft-tissue interventions relative to traditional ones requires further exploration. The purpose of this pilot study was to evaluate the immediate effect of Instrument Assisted Soft Tissue Mobilization (IASTM) compared to Vibration Massage or Light Hand Massage on hamstrings' flexibility and knee proprioception.
METHODS


16 healthy non-injured male participants (mean age 23.7 years, height 1.80 cms and body mass 77.7 kg) were randomly assigned to the following interventions: (a) 5min IASTM, (b) 5min Vibration Massage and (c) 8min Light Hand-Massage, sequentially delivered to all participants with an in-between 1-week time interval. A single application of each intervention was given over the hamstrings of their dominant leg (repeated measures under 3 different experimental conditions). An active knee angle reproduction proprioception test and the back-saver sit and reach flexibility test were performed before and immediately after each intervention. Reliability of outcomes was also assessed.
RESULTS


Reliability for flexibility (ICC 3,1  = 0.97-0.99/SEM = 0.83-1.52 cm) and proprioception (ICC 3,1  = 0.83-0.88/SEM = 1.63-2.02°) was very good. For flexibility, statistically significant immediate improvement (p < 0.001) was noted in all 3 groups (1.61-3.23 cm), with no between-group differences. For proprioception, improvement in the IASTM (2.12°), Vibration Massage (0.32°) and Light Hand-Massage (1.17°) conditions was not statistically significant; no between-group differences were also evident.
CONCLUSIONS


Our findings indicate that muscle flexibility was positively influenced immediately after a single intervention of IASTM, Vibration Massage or Light Hand Massage. Proprioception changes were not statistically significant either within or between groups. Further evaluation of those interventions in a larger population with hamstrings pathology is required.",2020,"For flexibility, statistically significant immediate improvement (p < 0.001) was noted in all 3 groups (1.61-3.23 cm), with no between-group differences.","['16 healthy non-injured male participants ', 'mean age 23.7 years, height 1.80\xa0cms and body mass 77.7\xa0kg']","['Instrument Assisted Soft Tissue Mobilization (IASTM', 'novel soft-tissue interventions', 'IASTM vs. Vibration vs. Light Hand Massage', 'Vibration Massage or Light Hand Massage', '5min IASTM, (b) 5min Vibration Massage and (c) 8min Light Hand-Massage']","['knee angle repositioning accuracy and hamstrings flexibility', 'Proprioception changes', 'Vibration Massage', 'muscle flexibility']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0041718', 'cui_str': 'Centers for Medicare and Medicaid Services'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0686940', 'cui_str': 'Soft tissue mobilization'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0556030', 'cui_str': 'Repositioning'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0584895', 'cui_str': 'Posterior muscle of thigh structure'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0033499', 'cui_str': 'Proprioception'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}]",16.0,0.0143657,"For flexibility, statistically significant immediate improvement (p < 0.001) was noted in all 3 groups (1.61-3.23 cm), with no between-group differences.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Koumantakis', 'Affiliation': '401 General Army Hospital of Athens, Physiotherapy Department, Pan. Kanellopoulou 1, Athens, Greece; Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK. Electronic address: g.koumantakis2@gmail.com.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Roussou', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Georgios A', 'Initials': 'GA', 'LastName': 'Angoules', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Nikolaos A', 'Initials': 'NA', 'LastName': 'Angoules', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Alexandropoulos', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Mavrokosta', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Prokopios', 'Initials': 'P', 'LastName': 'Nikolaou', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Filippi', 'Initials': 'F', 'LastName': 'Karathanassi', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Papadopoulou', 'Affiliation': 'Metropolitan College, Health Sciences Faculty, School of Physiotherapy, Athens, Greece - Affiliated Institution with Queen Margaret University, Edinburgh, UK.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2020.02.007']
2956,32826035,"Comment on A Prospective, Randomized Trial of Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension for Acute Bacterial Conjunctivitis.",,2020,,['Acute Bacterial Conjunctivitis'],['Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension'],[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009768', 'cui_str': 'Bacterial conjunctivitis'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0706574', 'cui_str': 'Dexamethasone 1 MG/ML Ophthalmic Suspension [Maxidex]'}]",[],,0.0247975,,"[{'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Kanclerz', 'Affiliation': 'Gdańsk, Poland.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Myers', 'Affiliation': 'Chicago, Illinois, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.04.045']
2957,32826036,"Reply to Comment on: A Prospective, Randomized Trial of Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension for Acute Bacterial Conjunctivitis.",,2020,,['Acute Bacterial Conjunctivitis'],['Povidone-Iodine 0.6% and Dexamethasone 0.1% Ophthalmic Suspension'],[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0009768', 'cui_str': 'Bacterial conjunctivitis'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0706574', 'cui_str': 'Dexamethasone 1 MG/ML Ophthalmic Suspension [Maxidex]'}]",[],,0.0214747,,"[{'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Ta', 'Affiliation': 'Palo Alto, California, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Raizman', 'Affiliation': 'Boston, Massachusetts, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Gross', 'Affiliation': 'Dallas, Texas, USA.'}, {'ForeName': 'Sunir', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'Fort Lauderdale, Florida, USA.'}, {'ForeName': 'Sushanta', 'Initials': 'S', 'LastName': 'Mallick', 'Affiliation': 'Lexington, Massachusetts, USA.'}, {'ForeName': 'Yuemei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Lexington, Massachusetts, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Segal', 'Affiliation': 'Delray Beach, Florida, USA.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.006']
2958,32826183,Comparison of the efficacy of desmopressin fast-melting formulation and enuretic alarm in the treatment of monosymptomatic nocturnal enuresis.,"BACKGROUND


Primary monosymptomatic nocturnal enuresis (MNE) is a common pediatric condition and there are two firstline, evidence-based treatments available; desmopressin and the enuresis alarm. Although there are many studies comparing enuresis alarm and desmopressin treatments in the literature, most were conducted using old formulations of desmopressin.
OBJECTIVE


To compare the efficacy of desmopressin MELT formulation and enuresis alarm therapy in patients with MNE.
STUDY DESIGN


A total of 130 patients who had primary MNE were included in the study. The patients were divided into two groups using simple randomization; desmopressin MELT (Group 1, n = 66) and enuresis alarm (Group 2, n = 64). The patients were invited for a follow-up visit at the fourth, 12th and 24th weeks of treatment. Treatment response and compliance were evaluated using bed-wetting diary and ICSS criteria.
RESULTS


The mean age of the patients Group 1 and 2 was 11.2 + 3.3 and 10.2 + 3.4 years, respectively (p = 0.104). Complete response rate was similar at 4th week (53% vs. 37.3%, p = 0.162) and at 12th week (68.4% vs. 68.2%, p = 0.257). The relapse rate was significantly higher in the desmopressin MELT group than in the enuresis alarm group (48.9% vs 20.5%, p = 0.007). At the end of the study ten patients were excluded from the study because of loss to follow-up and/or side effects. The overall complete response rate was significantly higher in the enuresis alarm group than in the desmopressin MELT group at the end of the study (41.3% vs 64.9%, p = 0.035). When the intention to treat analysis population was considered, similarly the complete response rate was significantly higher in the enuresis alarm group than in the desmopressin MELT group (40.9% vs 64.1%, p = 0.027).
DISCUSSION


With regard to the management of children with MNE, our study revealed that desmopressin MELT and enuresis alarm both have high efficacy rates in primary MNE treatment both at 4th and 12th week. However, overall complete response rate was better in enuresis alarm treatment at 24th week. In addition, enuresis alarm treatment also presents as a more favorable relapse rate.
CONCLUSIONS


Enuresis alarm presented a more permanent treatment response and a lower relapse rate than desmopressin MELT formulation.",2020,"Complete response rate was similar at 4th week (53% vs. 37.3%, p = 0.162) and at 12th week (68.4% vs. 68.2%, p = 0.257).","['patients with MNE', '130 patients who had primary MNE were included in the study', 'monosymptomatic nocturnal enuresis', 'children with MNE']","['simple randomization; desmopressin MELT', 'desmopressin MELT formulation and enuresis alarm therapy', 'desmopressin fast-melting formulation and enuretic alarm', 'enuresis alarm', 'desmopressin MELT']","['relapse rate', 'Complete response rate', 'complete response rate', 'overall complete response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0270327', 'cui_str': 'Nocturnal enuresis'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011701', 'cui_str': 'desmopressin'}, {'cui': 'C0050572', 'cui_str': 'ACP protocol'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0178997', 'cui_str': 'Nocturnal bladder warning system'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",130.0,0.0240102,"Complete response rate was similar at 4th week (53% vs. 37.3%, p = 0.162) and at 12th week (68.4% vs. 68.2%, p = 0.257).","[{'ForeName': 'Tanju', 'Initials': 'T', 'LastName': 'Keten', 'Affiliation': 'University of Health Sciences, Ankara Numune Research and Training Hospital, Department of Urology, Ankara, Turkey.'}, {'ForeName': 'Yilmaz', 'Initials': 'Y', 'LastName': 'Aslan', 'Affiliation': 'University of Health Sciences, Ankara Numune Research and Training Hospital, Department of Urology, Ankara, Turkey. Electronic address: https://twitter.com/urodrya.'}, {'ForeName': 'Melih', 'Initials': 'M', 'LastName': 'Balci', 'Affiliation': 'University of Health Sciences, Ankara Numune Research and Training Hospital, Department of Urology, Ankara, Turkey.'}, {'ForeName': 'Anil', 'Initials': 'A', 'LastName': 'Erkan', 'Affiliation': 'University of Health Sciences, Ankara Numune Research and Training Hospital, Department of Urology, Ankara, Turkey.'}, {'ForeName': 'Cagdas', 'Initials': 'C', 'LastName': 'Senel', 'Affiliation': 'University of Health Sciences, Ankara Numune Research and Training Hospital, Department of Urology, Ankara, Turkey.'}, {'ForeName': 'Ural', 'Initials': 'U', 'LastName': 'Oguz', 'Affiliation': 'University of Giresun, Department of Urology, Giresun, Turkey.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Kayali', 'Affiliation': 'University of Health Sciences, Ankara Numune Research and Training Hospital, Department of Urology, Ankara, Turkey.'}, {'ForeName': 'Ozer', 'Initials': 'O', 'LastName': 'Guzel', 'Affiliation': 'University of Health Sciences, Ankara Numune Research and Training Hospital, Department of Urology, Ankara, Turkey.'}, {'ForeName': 'Erdem', 'Initials': 'E', 'LastName': 'Karabulut', 'Affiliation': 'University of Hacettepe, Department of Biostatistics, Ankara, Turkey.'}, {'ForeName': 'Altug', 'Initials': 'A', 'LastName': 'Tuncel', 'Affiliation': 'University of Health Sciences, Ankara Numune Research and Training Hospital, Department of Urology, Ankara, Turkey.'}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.07.018']
2959,32826188,How periarticular corticosteroid injections impact the integrity of arthroscopic rotator cuff repair.,"INTRODUCTION


Multimodal analgesic (MMA) injections combined with corticosteroids have recently been shown to be effective for managing pain after arthroscopic rotator cuff repair.
HYPOTHESIS


The goal of this study was to analyze the effects of corticosteroid injections on the integrity of tendon repairs using magnetic resonance imaging (MRI). The hypothesis was that MMA injections combined with corticosteroids have no deleterious effects on functional outcomes and tendon healing 1 year after surgical rotator cuff repair.
METHODS


This was a prospective, double-blind study of 50 patients undergoing arthroscopic rotator cuff repair who were randomized into two groups. The study group (n=25) received a periarticular injection of a mixture of ropivacaine, morphine and methylprednisolone at the end of the procedure. The control group (n=25) received a placebo injection. The clinical outcomes were the pain level and complications, while the functional outcomes consisted of the Constant-Murley Score (CMS), American Shoulder and Elbow Surgeons Shoulder (ASES) score and Simple Shoulder Test (SST). The structural integrity of the operated tendons was analyzed on MRI at a mean follow-up of 15.1±1.3 months for the study group and 15.2±1.1 for the control group (p=0.848).
RESULTS


Pain on a visual analog scale was significantly reduced in both groups after the surgery. Nevertheless, there was no significant difference between groups at the final follow-up visit (p=0.803). Compared to the preoperative values, the CMS, ASES and SST significantly improved in both groups after surgery but were not significantly different between groups at the final assessment (p=0.801, 0.869 and 0.769, respectively). MRI revealed supraspinatus tendon retears in 16% of patients in the study group and 36% in the control group (p=0.107). There were no infections in the study group as of the final assessment. Advanced age (p=0.049), diabetes (p<0.01) and posterior extension of the tear (p=0.039) negatively impact healing. Corticosteroid injection did not negatively impact healing (p=0.197).
CONCLUSION


This study shows that MMA injection combined with corticosteroids does not alter the tendon healing, clinical outcomes, or functional outcomes 1 year after arthroscopic rotator cuff repair. It remains a safe and effective analgesia method during rotator cuff repair surgery.
LEVEL OF EVIDENCE


II, low-powered placebo-controlled, randomized study.",2020,MRI revealed supraspinatus tendon retears in 16% of patients in the study group and 36% in the control group (p=0.107).,"['50 patients undergoing arthroscopic rotator cuff repair', 'arthroscopic rotator cuff repair']","['periarticular injection of a mixture of ropivacaine, morphine and methylprednisolone', 'Corticosteroid injection', 'MMA injections combined with corticosteroids', 'placebo injection', 'Multimodal analgesic (MMA) injections combined with corticosteroids', 'magnetic resonance imaging (MRI', 'corticosteroid injections', 'MMA injection combined with corticosteroids']","['CMS, ASES and SST', 'pain level and complications, while the functional outcomes consisted of the Constant-Murley Score (CMS), American Shoulder and Elbow Surgeons Shoulder (ASES) score and Simple Shoulder Test (SST', 'visual analog scale', 'supraspinatus tendon retears']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0186666', 'cui_str': 'Repair of musculotendinous cuff of shoulder'}]","[{'cui': 'C0595695', 'cui_str': 'Periarticular route'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0066409', 'cui_str': 'Methylmethacrylate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}]",50.0,0.151985,MRI revealed supraspinatus tendon retears in 16% of patients in the study group and 36% in the control group (p=0.107).,"[{'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Perdreau', 'Affiliation': ""Orthopedic and Trauma Surgery Department, Centre Hospitalier de l'Ardenne, Avenue de Houffalize 35, Libramont-Chevigny, 6800 Province du Luxembourg, Belgium. Electronic address: perdreaua@hotmail.com.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Duysens', 'Affiliation': 'Institut Européen de la main, Centre Hospitalier du Kirchberg, Grand Duchy of Luxembourg, Luxembourg.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Joudet', 'Affiliation': 'Orthopedic Surgery Department, Clinique Chirurgicale du Libournais, Libourne, France.'}]","Orthopaedics & traumatology, surgery & research : OTSR",['10.1016/j.otsr.2020.05.009']
2960,32826199,"Corrigendum to ""Virtual immersive gaming to optimize recovery (VIGOR) in low back pain: A phase II randomized controlled trial"" [Contemporary Clinical Trials 69 (2018) 83-91].",,2020,,['low back pain'],[],[],"[{'cui': 'C0024031', 'cui_str': 'Low back pain'}]",[],[],,0.0855818,,"[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'France', 'Affiliation': 'Department of Psychology, Ohio University, Athens, OH, USA. Electronic address: France@ohio.edu.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Thomas', 'Affiliation': 'Department of Physical Therapy, Virginia Commonwealth University, Richmond, VA, USA; Department of Physical Medicine & Rehabilitation, Virginia Commonwealth University, Richmond, VA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106120']
2961,32826319,Peptide Receptor Radionuclide Therapy of Late-stage Neuroendocrine Tumor Patients with Multiple Cycles of  177 Lu-DOTA-EB-TATE.,"Purpose:  This study aimed to evaluate the safety and efficacy of multiple cycles of  177 Lu-DOTA-EB-TATE peptide receptor radionuclide therapy (PRRT) at escalating doses in neuroendocrine tumors (NETs).  Methods:  A total of 32 NET patients were randomly divided into 3 groups and treated with escalating doses: group A (1.17 ± 0.09 GBq/cycle); group B (1.89 ± 0.53 GBq/cycle); group C (3.97 ± 0.84 GBq/cycle). The treatment was planned up to three cycles. Treatment-related adverse events (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v.5.0). Treatment response was referred to European Organization for Research and Treatment of Cancer criteria (EORTC) and modified positron emission tomography response criteria in solid tumors (PERCIST) criteria.  Results:  Administration of PRRT was well tolerated without life-threatening (CTC-4) AEs. CTC-3 hematotoxicity was recorded in 1 patient (16.6%) in group B (thrombocytopenia) and 3 patients (21.4%) in group C (thrombocytopenia in 3, anemia in 1). CTC-3 hepatotoxicity was recorded in 1 patient in group A (8.3%) and C (7.1%), respectively with elevated AST. No nephrotoxicity was observed. When referring to EORTC criteria, the overall disease response rates (DRR) were similar in groups A-C (50.0%, 50.0%, and 42.9%, respectively), and the overall disease control rates (DCR) were higher in group B (83.3%) and C (71.5%) than that in group A (66.7%). When referring to modified PERCIST criteria, lower DRR but similar DCR was found. When selecting comparable baseline SUV max  ranging from 15 to 40, the ΔSUV max % had slight increase in group A (ΔSUV max % = 2.1 ± 40.8) but significant decrease in groups B and C (ΔSUV max % = -38.7 ± 10.0 and -14.7 ± 20.0) after the 1st PRRT ( P  =0.001), and had decrease in all three groups after the 3rd PRRT (groups A-C, ΔSUV max %= -6.9 ± 42.3, -49.2 ± 30.9, -11.9 ± 37.9,  P  = 0.044).  Conclusion:  Escalated doses of  177 Lu-DOTA-EB-TATE up to 3.97 GBq/cycle seem to be well tolerated. 1.89 GBq/cycle and 3.97 GBq/cycle  177 Lu-DOTA-EB-TATE were both effective in tumor control and more effective than 1.17 GBq/cycle  177 Lu-DOTA-EB-TATE.",2020,"CTC-3 hematotoxicity was recorded in 1 patient (16.6%) in group B (thrombocytopenia) and 3 patients (21.4%) in group C (thrombocytopenia in 3, anemia in 1).","['A total of 32 NET patients', 'Late-stage Neuroendocrine Tumor Patients with Multiple Cycles of  177 Lu-DOTA-EB-TATE']","['multiple cycles of  177 Lu-DOTA-EB-TATE peptide receptor radionuclide therapy (PRRT', 'PRRT', 'Peptide Receptor Radionuclide Therapy']","['overall disease response rates (DRR', 'tolerated', 'overall disease control rates (DCR', 'nephrotoxicity', 'safety and efficacy', 'CTC-3 hepatotoxicity', 'CTC-3 hematotoxicity']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279941', 'cui_str': 'Late stage'}, {'cui': 'C0206754', 'cui_str': 'Neuroendocrine tumor'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C2959378', 'cui_str': 'Lutetium-177'}, {'cui': 'C0088359', 'cui_str': '1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C2959378', 'cui_str': 'Lutetium-177'}, {'cui': 'C0088359', 'cui_str': '1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid'}, {'cui': 'C0206473', 'cui_str': 'Peptide Receptor'}, {'cui': 'C0203608', 'cui_str': 'Radionuclide therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010931', 'cui_str': 'Dacryocystorhinostomy'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0920103', 'cui_str': 'Haematotoxicity'}]",32.0,0.0258005,"CTC-3 hematotoxicity was recorded in 1 patient (16.6%) in group B (thrombocytopenia) and 3 patients (21.4%) in group C (thrombocytopenia in 3, anemia in 1).","[{'ForeName': 'Qingxing', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Peking Union Medical College, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zang', 'Affiliation': 'Peking Union Medical College, China.'}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Sui', 'Affiliation': 'Peking Union Medical College, China.'}, {'ForeName': 'Jiakun', 'Initials': 'J', 'LastName': 'Ren', 'Affiliation': 'Peking Union Medical College, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Peking Union Medical College, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Peking Union Medical College, China.'}, {'ForeName': 'Rongxi', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Peking Union Medical College, China.'}, {'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Jacobson', 'Affiliation': 'National Institutes of Health, USA.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Peking Union Medical College, China.'}, {'ForeName': 'Yuejuan', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Peking Union Medical College, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Peking Union Medical College, China.'}, {'ForeName': 'Xiaoyuan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'National Institutes of Health, USA.'}]","Journal of nuclear medicine : official publication, Society of Nuclear Medicine",['10.2967/jnumed.120.248658']
2962,32826390,Randomized Controlled Study to Compare Uncovered Stent Versus Covered Stent as Percutaneous Endoprosthesis for Malignant Biliary Obstruction (JIVROSG-0207).,"OBJECTIVES


The objective of this study was to compare the clinical effectiveness of uncovered stent and covered stent as percutaneous endoprosthesis for malignant biliary obstruction of the extrahepatic bile duct.
MATERIALS AND METHODS


After completion of percutaneous internal and external tube placement for unresectable malignant biliary obstruction, 60 patients were registered and randomly assigned in a 1:1 ratio to an uncovered or covered stent group. Metallic stent placement was performed within 1 week after registration, and an external biliary drainage tube was removed >3 days after stent placement. The primary endpoint was the obstructive jaundice-free survival rate at 24 weeks after registration, and the secondary endpoints were the success rate of percutaneous tube removal and adverse events.
RESULTS


The obstructive jaundice-free survival rate at 24 weeks after registration was 13/29 (44.8%, 95% confidence interval [CI]: 28.4%-62.5%) and 15/30 (50.0%, 95% CI: 33.2%-66.8%) in the uncovered and covered stent groups, respectively. The success rate of percutaneous tube removal was 28/29 (96.6%, 95% CI: 82.8%-99.4%) and 30/30 (100%, 95% CI: 90.5%-100%) in the uncovered and covered stent groups, respectively. There were no procedure-related deaths. Twenty-eight adverse events were observed in 21 patients (7 in the uncovered stent group and 14 in the covered stent group).
CONCLUSIONS


There was no significant difference in the obstructive jaundice-free survival rate at 24 weeks between the 2 groups. Considering the technical difficulty and invasiveness of covered stent placement, the placement of covered stents may not be needed in patients with a short prognosis of <24 weeks.",2020,"The success rate of percutaneous tube removal was 28/29 (96.6%, 95% CI: 82.8%-99.4%) and 30/30 (100%, 95% CI: 90.5%-100%) in the uncovered and covered stent groups, respectively.","['Malignant Biliary Obstruction (JIVROSG-0207', 'unresectable malignant biliary obstruction, 60 patients']","['percutaneous internal and external tube placement', 'Metallic stent placement', 'stent and covered stent as percutaneous endoprosthesis', 'Stent Versus Covered Stent as Percutaneous Endoprosthesis']","['success rate of percutaneous tube removal and adverse events', 'procedure-related deaths', 'success rate of percutaneous tube removal', 'adverse events', 'obstructive jaundice-free survival rate']","[{'cui': 'C3898473', 'cui_str': 'Malignant biliary obstruction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441290', 'cui_str': 'Metal stent'}, {'cui': 'C0038257', 'cui_str': 'Stent'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C4704931', 'cui_str': 'Endoprostheses'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022354', 'cui_str': 'Obstructive hyperbilirubinemia'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",60.0,0.277076,"The success rate of percutaneous tube removal was 28/29 (96.6%, 95% CI: 82.8%-99.4%) and 30/30 (100%, 95% CI: 90.5%-100%) in the uncovered and covered stent groups, respectively.","[{'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Onishi', 'Affiliation': 'Department of Diagnostic Radiology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Radiology, Nishinara Central Hospital.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Arai', 'Affiliation': 'Department of Diagnostic Radiology, National Cancer Center Hospital, Tokyo.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Inaba', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Aichi.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Saito', 'Affiliation': 'Department of Radiology, Sapporo Higashi Tokushukai Hospital, Hokkaido.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Aramaki', 'Affiliation': 'Division of Interventional Radiology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Anai', 'Affiliation': 'Department of Radiology, Nara Medical University, Nara.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Sone', 'Affiliation': 'Department of Diagnostic Radiology, National Cancer Center Hospital, Tokyo.'}]",American journal of clinical oncology,['10.1097/COC.0000000000000750']
2963,32826409,A Maternal-Administered Multimodal Neonatal Bundle in Hospitalized Very Preterm Infants: A Pilot Study.,"BACKGROUND


Premature infants are at an increased risk for developing cerebral palsy (CP). Evidence-based strategies designed to promote healthy brain development and facilitate adaptation after brain injury in infants still admitted to the neonatal intensive care unit (NICU) represent a novel approach that may lead to improved long-term outcomes.
PURPOSE


To investigate the feasibility of a maternal-administered early intervention bundle in very preterm infants prior to NICU discharge.
METHODS


A pilot trial evaluating a maternal-administered NICU-based bundle of interventions in preterm infants (≤32 weeks' gestational age and/or ≤1500 g birth weight). The impact of the bundle on short-term developmental outcomes of infants, as well as maternal stress, anxiety, and depression, is evaluated.
RESULTS


The intervention bundle was implemented in 11 mother-infant dyads (including 1 set of twins) for a median of 8 weeks and was overall well received. Vocal soothing, scent exchange, and comforting touch were feasible, performed at or above the predetermined goal of 71% of the time (5/7 days), while kangaroo care and infant massage were not. Maternal stress, anxiety, and depression were decreased during the study time.
IMPLICATIONS TO PRACTICE


A neonatal multimodal intervention bundle provided by mothers is feasible.
IMPLICATIONS TO RESEARCH


Additional randomized controlled studies are needed to determine whether this type of bundled interventions can (1) improve the neurodevelopmental outcomes of participating infants and (2) improve long-term parental outcomes, including decreased burden of anxiety and depression, as well as improved attachment and optimal patterns of social interaction.",2020,"Maternal stress, anxiety, and depression were decreased during the study time.
","['infants still admitted to the neonatal intensive care unit (NICU', 'very preterm infants prior to NICU discharge', 'Hospitalized Very Preterm Infants', ""preterm infants (≤32 weeks' gestational age and/or ≤1500 g birth weight""]","['maternal-administered NICU-based bundle of interventions', 'maternal-administered early intervention bundle']","['maternal stress, anxiety, and depression', 'neurodevelopmental outcomes', 'Maternal stress, anxiety, and depression']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C3897192', 'cui_str': 'Very preterm infant'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.048284,"Maternal stress, anxiety, and depression were decreased during the study time.
","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Letzkus', 'Affiliation': ""Divisions of Developmental Pediatrics (Dr Letzkus) and Neonatology (Drs Alonzo and Zanelli), Department of Pediatrics, and Children's Hospital Physical and Occupational Therapy (Drs Connaughton and Kelly), University of Virginia, Charlottesville.""}, {'ForeName': 'Corrie', 'Initials': 'C', 'LastName': 'Alonzo', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Connaughton', 'Affiliation': ''}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Kelly', 'Affiliation': ''}, {'ForeName': 'Santina', 'Initials': 'S', 'LastName': 'Zanelli', 'Affiliation': ''}]",Advances in neonatal care : official journal of the National Association of Neonatal Nurses,['10.1097/ANC.0000000000000786']
2964,32364618,Social cognitive intervention following an initial implantable cardioverter defibrillator: Better treatment response for secondary versus primary prevention.,"BACKGROUND


The patient + partner (P+P) is a patient/partner-focused social cognitive intervention with demonstrated efficacy to improve outcomes following an initial implantable cardioverter defibrillator (ICD). Little is known about how the patient response may differ by ICD implant indication. The aim of this study was to examine the response to intervention for patients with an initial ICD by reasons for primary versus secondary ICD indication.
METHOD


A longitudinal secondary analysis of data from a randomized clinical trial testing the P+P intervention examined patient health outcomes over 12 months, stratified by the indication for the ICD: primary prevention without cardiac resynchronization therapy (CRT) (1 o  No CRT, n = 100), primary prevention with CRT (1 o  CRT, n = 78), secondary prevention after cardiac arrest (2° Cardiac Arrest, n = 66), and secondary prevention for other arrhythmias (2 o  Other, n = 57). Outcomes included physical and mental health status (Short-Form-36 Physical Component Summary and Mental Component Summary), physical symptoms (Patient Concerns Assessment), depression (Patient-Health-Questionniare-9), and anxiety (State-Trait Anxiety Inventory).
RESULTS


Participants (n = 301) were on average 64 years old, primarily male (73.7%) and Caucasian (91%) with reduced ejection fraction (34%). There were no baseline differences between ICD groups for all outcomes (P > .05). Patients in the 2° Cardiac Arrest group showed greater improvement from baseline to 3 months in physical and mental health outcomes. The 2° Cardiac Arrest group had better physical (F = 11.48, P = .004) and mental health (F = 4.34, P = .038) and less severe physical (z = 2.24, P = 0.013) and depressive symptoms (z = 2.71, P = .003) at 12 months compared to the 1 o  No CRT group.
CONCLUSION


The P+P intervention was more effective for promoting physical and psychological health outcomes for individuals receiving an ICD for 2 o  prevention after cardiac arrest.",2020,"The 2° Cardiac Arrest group had better physical (F = 11.48, P = .004) and mental health (F = 4.34, P = .038) and less severe physical (z = 2.24, P = 0.013) and depressive symptoms (z = 2.71, P = .003) at 12 months compared to the 1 o  No CRT group.
","['1 o  CRT, n\xa0=\xa078), secondary prevention after cardiac arrest (2° Cardiac Arrest, n\xa0=\xa066), and secondary prevention for other arrhythmias (2 o  Other, n\xa0=\xa057', 'individuals receiving an ICD for 2 o  prevention after cardiac arrest', 'Participants (n\xa0', '301) were on average 64 years old, primarily male (73.7%) and Caucasian (91%) with reduced ejection fraction (34', 'patients with an initial ICD by reasons for primary versus secondary ICD indication']","['cardiac resynchronization therapy (CRT) (1 o  No CRT, n\xa0=\xa0100), primary prevention with CRT', 'P+P intervention', 'Social cognitive intervention', 'initial implantable cardioverter defibrillator', 'initial implantable cardioverter defibrillator (ICD']","['physical and mental health status (Short-Form-36 Physical Component Summary and Mental Component Summary), physical symptoms (Patient Concerns Assessment), depression (Patient-Health-Questionniare-9), and anxiety (State-Trait Anxiety Inventory', 'severe physical', 'mental health', 'physical and psychological health outcomes', 'depressive symptoms']","[{'cui': 'C1175953', 'cui_str': '1-O-(rhamnopyranosyl-(1-2)-6-O-acetyl-galactopyranosyl)-1,3,22,26-tetrahydroxy-furost-5(6)-en-26-O-glucopyranoside'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0679699', 'cui_str': 'Secondary prevention'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C1175953', 'cui_str': '1-O-(rhamnopyranosyl-(1-2)-6-O-acetyl-galactopyranosyl)-1,3,22,26-tetrahydroxy-furost-5(6)-en-26-O-glucopyranoside'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0033144', 'cui_str': 'Primary prevention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",301.0,0.0613752,"The 2° Cardiac Arrest group had better physical (F = 11.48, P = .004) and mental health (F = 4.34, P = .038) and less severe physical (z = 2.24, P = 0.013) and depressive symptoms (z = 2.71, P = .003) at 12 months compared to the 1 o  No CRT group.
","[{'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Auld', 'Affiliation': 'School of Nursing, Biobehavioral Nursing and Health Informatics, University of Washington, Seattle, Washington.'}, {'ForeName': 'Elaine A', 'Initials': 'EA', 'LastName': 'Thompson', 'Affiliation': 'School of Nursing, Psychosocial and Community Health, University of Washington, Seattle, Washington.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Dougherty', 'Affiliation': 'School of Nursing, Biobehavioral Nursing and Health Informatics, University of Washington, Seattle, Washington.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.13929']
2965,29209951,Relationship of left ventricular global longitudinal strain with cardiac autonomic denervation as assessed by  123 I-mIBG scintigraphy in patients with heart failure with reduced ejection fraction submitted to cardiac resynchronization therapy : Assessment of cardiac autonomic denervation by GLS in patients with heart failure with reduced ejection fraction submitted to CRT.,"BACKGROUND


Heart failure (HF) is associated with cardiac autonomic denervation (AD), which can be non-invasively assessed by  123 I-metaiodobenzylguanidine ( 123 I-mIBG) scintigraphy and has prognostic implications. We aimed to study the relationship between myocardial contractility assessed by global longitudinal strain (GLS) and AD assessed by  123 I-mIBG scintigraphy in advanced HF.
METHODS/RESULTS


BETTER-HF is a prospective randomized clinical trial including HF patients (pts) submitted to cardiac resynchronization therapy (CRT) who are submitted to a clinical, echocardiographic, and scintigraphic assessment before and 6 months after CRT. 81 pts were included. An echocardiographic response (absolute increase in left ventricular ejection fraction ≥ 10%) was observed in 73.7% of pts. A higher baseline late heart-to-mediastinum ratio (HMR) was associated with a better echocardiographic response. There was a significant association between late HMR and GLS at baseline and 6 months. At baseline, GLS had an AUC of 0.715 for discrimination for a late HMR < 1.6. A GLS cut-off of - 9% maximized the likelihood of correctly classifying a pt as having severe AD (HMR < 1.6).
CONCLUSION


Myocardial contractility as assessed by GLS is moderately correlated with AD as assessed by  123 I-mIBG scintigraphy and has a good discrimination for the identification of severe cardiac denervation. GLS may allow for a more readily accessible estimation of the degree of AD in advanced HF pts.",2019,A higher baseline late heart-to-mediastinum ratio (HMR) was associated with a better echocardiographic response.,"['81 pts were included', 'patients with heart failure with reduced ejection fraction submitted to CRT', 'patients with heart failure with reduced ejection fraction submitted to', 'HF patients (pts) submitted to']","['GLS', 'global longitudinal strain (GLS) and AD assessed by  123 I-mIBG scintigraphy', 'cardiac resynchronization therapy ', 'cardiac resynchronization therapy (CRT']","['echocardiographic response', 'late HMR and GLS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}]","[{'cui': 'C0017767', 'cui_str': 'Glucosinolate'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0206233', 'cui_str': 'Denervation, Autonomic'}, {'cui': 'C3495673', 'cui_str': 'IODIDE ION I-123'}, {'cui': 'C0047506', 'cui_str': '3-Iodobenzylguanidine'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0025066', 'cui_str': 'Mediastinal'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0017767', 'cui_str': 'Glucosinolate'}]",81.0,0.0620618,A higher baseline late heart-to-mediastinum ratio (HMR) was associated with a better echocardiographic response.,"[{'ForeName': 'Madalena Coutinho', 'Initials': 'MC', 'LastName': 'Cruz', 'Affiliation': 'Serviço de Cardiologia, Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Lisboa Central, EPE, Rua de Santa Marta, 50, 1169-024, Lisbon, Portugal. madalena.cruz89@gmail.com.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Abreu', 'Affiliation': 'Serviço de Cardiologia, Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Lisboa Central, EPE, Rua de Santa Marta, 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Portugal', 'Affiliation': 'Serviço de Cardiologia, Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Lisboa Central, EPE, Rua de Santa Marta, 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Santa-Clara', 'Affiliation': 'CIPER, Human Kinetics Faculty, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Pedro S', 'Initials': 'PS', 'LastName': 'Cunha', 'Affiliation': 'Serviço de Cardiologia, Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Lisboa Central, EPE, Rua de Santa Marta, 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Mario M', 'Initials': 'MM', 'LastName': 'Oliveira', 'Affiliation': 'Serviço de Cardiologia, Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Lisboa Central, EPE, Rua de Santa Marta, 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Santos', 'Affiliation': 'CIPER, Human Kinetics Faculty, University of Lisbon, Lisbon, Portugal.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Oliveira', 'Affiliation': 'Nuclear Medicine Department, Medical and Diagnosis Clinic Quadrantes, Lisbon, Portugal.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Rio', 'Affiliation': 'Serviço de Cardiologia, Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Lisboa Central, EPE, Rua de Santa Marta, 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Inês', 'Initials': 'I', 'LastName': 'Rodrigues', 'Affiliation': 'Serviço de Cardiologia, Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Lisboa Central, EPE, Rua de Santa Marta, 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Luís A', 'Initials': 'LA', 'LastName': 'Morais', 'Affiliation': 'Serviço de Cardiologia, Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Lisboa Central, EPE, Rua de Santa Marta, 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Rui C', 'Initials': 'RC', 'LastName': 'Ferreira', 'Affiliation': 'Serviço de Cardiologia, Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Lisboa Central, EPE, Rua de Santa Marta, 50, 1169-024, Lisbon, Portugal.'}, {'ForeName': 'Miguel M', 'Initials': 'MM', 'LastName': 'Carmo', 'Affiliation': 'Serviço de Cardiologia, Department of Cardiology, Hospital de Santa Marta, Centro Hospitalar Lisboa Central, EPE, Rua de Santa Marta, 50, 1169-024, Lisbon, Portugal.'}]",Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology,['10.1007/s12350-017-1148-9']
2966,31153849,Precursors and Development of Geographic Atrophy with Autofluorescence Imaging: Age-Related Eye Disease Study 2 Report Number 18.,"PURPOSE


To describe the sequence of events leading to development of geographic atrophy (GA) in age-related macular degeneration with fundus autofluorescence (FAF) imaging.
DESIGN


Post hoc analysis of FAF images from the Age-Related Eye Disease Study 2.
PARTICIPANTS


Fundus autofluorescence images of 120 eyes (109 patients) with incident GA and at least 2 years of preceding FAF images.
METHODS


Images of incident GA were stacked and aligned over FAF images of preceding annual visits. The regions of retina where incident GA developed were assessed on prior years' FAF images. These regions, defined as precursor lesions, were classified into minimal change autofluorescence, predominant hypoautofluorescence (decreased autofluorescence), predominant hyperautofluorescence (increased autofluorescence), and mixed autofluorescence. The natural progression in precursor lesions leading to GA formation and their associations with incident GA size and GA enlargement rate were evaluated.
MAIN OUTCOME MEASURES


Incident GA area and enlargement rate and precursor pattern frequency.
RESULTS


Incident GA had a mean area of 1.00 mm 2  (range, 0.15-8.22 mm 2 ) and an enlargement rate of 0.97 mm 2 /year (standard deviation, 1.66 mm 2 /year). Predominant hypoautofluorescence was the most common precursor lesion, increasing from 42% to 81% over 3 years before onset of GA. Almost 30% of eyes showed minimal change autofluorescence 3 years before GA. Among the other precursors, 70% progressed to predominant hypoautofluorescence before GA developed. The type of precursor lesions was not associated with incident GA area. Geographic atrophy evolving from minimal change autofluorescence precursor lesions was associated with faster GA enlargement rates compared with other precursor lesion classes.
CONCLUSIONS


Using image registration, we identified changes in autofluorescence images before the onset of GA. Decreased autofluorescence was the most common change, although minimal changes also were seen in one third of the images. Incident GA that arises from predominantly normal autofluorescence is associated with faster enlargement rates compared with GA arising from abnormal autofluorescence. Faster GA enlargement rates also were associated with incident GA size, area of surround abnormal autofluorescence, and presence of reticular pseudodrusen.",2019,"Geographic atrophy evolving from minimal change autofluorescence precursor lesions was associated with faster GA enlargement rates compared with other precursor lesion classes.
","['Fundus autofluorescence images of 120 eyes (109 patients) with incident GA and at least 2 years of preceding FAF images', 'age-related macular degeneration with fundus autofluorescence (FAF) imaging']",['Using image registration'],"['Incident GA area and enlargement rate and precursor pattern frequency', 'incident GA size and GA enlargement rate', 'enlargement rate', 'Faster GA enlargement rates', 'Decreased autofluorescence']","[{'cui': 'C4324299', 'cui_str': 'Fundus autofluorescence'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0242383', 'cui_str': 'Age related macular degeneration'}, {'cui': 'C5200843', 'cui_str': 'Fundus Autofluorescence Imaging'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C1536085', 'cui_str': 'Dry Macular Degeneration'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0020564', 'cui_str': 'Hypertrophy'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0544711', 'cui_str': 'Autofluorescence'}]",,0.0595856,"Geographic atrophy evolving from minimal change autofluorescence precursor lesions was associated with faster GA enlargement rates compared with other precursor lesion classes.
","[{'ForeName': 'Ian C', 'Initials': 'IC', 'LastName': 'Holmen', 'Affiliation': 'Fundus Photographic Reading Center, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Bryce', 'Initials': 'B', 'LastName': 'Aul', 'Affiliation': 'Fundus Photographic Reading Center, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Jeong W', 'Initials': 'JW', 'LastName': 'Pak', 'Affiliation': 'Fundus Photographic Reading Center, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Ralph Moeller', 'Initials': 'RM', 'LastName': 'Trane', 'Affiliation': 'Fundus Photographic Reading Center, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Blodi', 'Affiliation': 'Fundus Photographic Reading Center, University of Wisconsin, Madison, Wisconsin.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Klein', 'Affiliation': 'Casey Eye Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Clemons', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Chew', 'Affiliation': 'Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Amitha', 'Initials': 'A', 'LastName': 'Domalpally', 'Affiliation': 'Fundus Photographic Reading Center, University of Wisconsin, Madison, Wisconsin. Electronic address: domalpally@wisc.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Ophthalmology. Retina,['10.1016/j.oret.2019.04.011']
2967,31335582,Characterizing the Learning-to-Drive Period for Teens with Attention Deficits.,"OBJECTIVE


Motor vehicle collisions are the leading cause of death among teenagers, accounting for approximately 1 in 3 deaths for this age group. A number of factors increase crash risk for teen drivers, including vulnerability to distraction, poor judgment, propensity to engage in risky driving behaviors, and inexperience. These factors may be of particular concern and exacerbated among teens learning to drive with attention deficits. To our knowledge, our study is among the first to systematically investigate the experiences of novice adolescent drivers with attention deficits during the learner period of a Graduated Drivers Licensing program.
METHOD


Survey and on-road driving assessment (ODA) data were used to examine parent and teen confidence in the teens' driving ability, driving practice frequency, diversity of driving practice environments, and driving errors among teens with attention deficits as defined by attention-deficit/hyperactivity disorder (ADHD) diagnosis or parent-reported trouble staying focused (TSF).
RESULTS


When teens' driving skill was evaluated at the conclusion of the learner period, teens with ADHD exhibited more driving errors than their typically developing (TD) counterparts (p = 0.034). Teens with TSF were more likely to have their ODA terminated (p = 0.019), had marginally lower overall driving scores (p = 0.098), and exhibited more critical driving errors (p = 0.01) compared with TD teens.
CONCLUSION


These findings may have implications on the learning-to-drive period for adolescents with attention deficits. Adjustments may need to be made to the learner period for teens with attention deficits to account for attention impairments and to better instill safe driving behavior.",2019,"Teens with TSF were more likely to have their ODA terminated (p = 0.019), had marginally lower overall driving scores (p = 0.098), and exhibited more critical driving errors (p = 0.01) compared with TD teens.
","['Survey and on-road driving assessment', 'Teens with Attention Deficits', 'novice adolescent drivers with attention deficits during the learner period of a Graduated Drivers Licensing program', 'adolescents with attention deficits']",[],"['driving errors', 'overall driving scores', 'critical driving errors']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0041671', 'cui_str': 'Attention Deficit Disorder'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0242373', 'cui_str': 'Licensing'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],"[{'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0167313,"Teens with TSF were more likely to have their ODA terminated (p = 0.019), had marginally lower overall driving scores (p = 0.098), and exhibited more critical driving errors (p = 0.01) compared with TD teens.
","[{'ForeName': 'Haley J', 'Initials': 'HJ', 'LastName': 'Bishop', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Allison E', 'Initials': 'AE', 'LastName': 'Curry', 'Affiliation': ""Center for Injury Research and Prevention, Children's Hospital of Philadelphia, Philadelphia, PA.""}, {'ForeName': 'Despina', 'Initials': 'D', 'LastName': 'Stavrinos', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Jessica H', 'Initials': 'JH', 'LastName': 'Mirman', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham, Birmingham, AL.'}]",Journal of developmental and behavioral pediatrics : JDBP,['10.1097/DBP.0000000000000706']
2968,31776278,Boosting with AIDSVAX B/E Enhances Env Constant Region 1 and 2 Antibody-Dependent Cellular Cytotoxicity Breadth and Potency.,"Induction of protective antibodies is a critical goal of HIV-1 vaccine development. One strategy is to induce nonneutralizing antibodies (NNAbs) that kill virus-infected cells, as these antibody specificities have been implicated in slowing HIV-1 disease progression and in protection. HIV-1 Env constant region 1 and 2 (C1C2) monoclonal antibodies (MAbs) frequently mediate potent antibody-dependent cellular cytotoxicity (ADCC), making them an important vaccine target. Here, we explore the effect of delayed and repetitive boosting of RV144 vaccine recipients with AIDSVAX B/E on the C1C2-specific MAb repertoire. It was found that boosting increased clonal lineage-specific ADCC breadth and potency. A ligand crystal structure of a vaccine-induced broad and potent ADCC-mediating C1C2-specific MAb showed that it bound a highly conserved Env gp120 epitope. Thus, boosting to affinity mature these types of IgG C1C2-specific antibody responses may be one method by which to make an improved HIV vaccine with higher efficacy than that seen in the RV144 trial. IMPORTANCE  Over one million people become infected with HIV-1 each year, making the development of an efficacious HIV-1 vaccine an important unmet medical need. The RV144 human HIV-1 vaccine regimen is the only HIV-1 clinical trial to date to demonstrate vaccine efficacy. An area of focus has been on identifying ways by which to improve upon RV144 vaccine efficacy. The RV305 HIV-1 vaccine regimen was a follow-up boost of RV144 vaccine recipients that occurred 6 to 8 years after the conclusion of RV144. Our study focused on the effect of delayed boosting in humans on the vaccine-induced Env constant region 1 and 2 (C1C2)-specific antibody repertoire. It was found that boosting with an HIV-1 Env vaccine increased C1C2-specific antibody-dependent cellular cytotoxicity potency and breadth.",2020,The RV144 human HIV-1 vaccine regimen is the only HIV-1 clinical trial to date to demonstrate vaccine efficacy.,[],['RV144 vaccine recipients with AIDSVAX B/E'],"['clonal lineage-specific ADCC breadth and potency', 'C1C2-specific antibody-dependent cellular cytotoxicity potency and breadth']",[],"[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0675907', 'cui_str': 'AIDSVAX'}]","[{'cui': 'C0443640', 'cui_str': 'Specific antibody'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0301896', 'cui_str': 'Cell-mediated lympholysis'}]",1000000.0,0.0457887,The RV144 human HIV-1 vaccine regimen is the only HIV-1 clinical trial to date to demonstrate vaccine efficacy.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Easterhoff', 'Affiliation': 'Duke University, Durham, North Carolina, USA david.easterhoff@duke.edu guido.ferrari@duke.edu.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Pollara', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Luo', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Tolbert', 'Affiliation': 'Infectious Diseases Division, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.'}, {'ForeName': 'Brianna', 'Initials': 'B', 'LastName': 'Young', 'Affiliation': 'Department of Biochemistry and Molecular Biology, University of Maryland, Baltimore, Maryland, USA.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Mielke', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Jha', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': ""O'Connell"", 'Affiliation': 'U.S. Army Medical Directorate, AFRIMS, Bangkok, Thailand.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Vasan', 'Affiliation': 'U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Excler', 'Affiliation': 'U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Merlin L', 'Initials': 'ML', 'LastName': 'Robb', 'Affiliation': 'U.S. Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, Maryland, USA.'}, {'ForeName': 'Supachai', 'Initials': 'S', 'LastName': 'Rerks-Ngarm', 'Affiliation': 'Thai Ministry of Public Health, Nonthaburi, Thailand.'}, {'ForeName': 'Jaranit', 'Initials': 'J', 'LastName': 'Kaewkungwal', 'Affiliation': 'Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Punnee', 'Initials': 'P', 'LastName': 'Pitisuttithum', 'Affiliation': 'Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sorachai', 'Initials': 'S', 'LastName': 'Nitayaphan', 'Affiliation': 'Royal Thai Army Component, AFRIMS, Bangkok, Thailand.'}, {'ForeName': 'Faruk', 'Initials': 'F', 'LastName': 'Sinangil', 'Affiliation': 'Global Solutions of Infectious Diseases, South San Francisco, California, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tartaglia', 'Affiliation': 'Sanofi Pasteur, Swiftwater, Pennsylvania, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Phogat', 'Affiliation': 'Sanofi Pasteur, Swiftwater, Pennsylvania, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Kepler', 'Affiliation': 'Boston University, Boston, Massachusetts, USA.'}, {'ForeName': 'S Munir', 'Initials': 'SM', 'LastName': 'Alam', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Wiehe', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Kevin O', 'Initials': 'KO', 'LastName': 'Saunders', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'M Anthony', 'Initials': 'MA', 'LastName': 'Moody', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Marzena', 'Initials': 'M', 'LastName': 'Pazgier', 'Affiliation': 'Infectious Diseases Division, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.'}, {'ForeName': 'Barton F', 'Initials': 'BF', 'LastName': 'Haynes', 'Affiliation': 'Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Ferrari', 'Affiliation': 'Duke University, Durham, North Carolina, USA david.easterhoff@duke.edu guido.ferrari@duke.edu.'}]",Journal of virology,['10.1128/JVI.01120-19']
2969,32826636,Long-Term and Acute Benefits of Reduced Sitting on Vascular Flow and Function.,"PURPOSE


Sedentary behavior increases the risk for cardiovascular and cerebrovascular disease. To understand potential benefits and underlying mechanisms, we examined the acute and long-term impact of reduced sitting-intervention on vascular and cerebrovascular function.
METHODS


This prospective study included 24 individuals with increased cardiovascular risk (65±5 years, 29.8±3.9 kg/m). Before and after 16-week reduced sitting, using a mobile-Health device with vibrotactile feedback, we examined: i. vascular function (flow-mediated dilation (FMD)), ii. cerebral blood flow (CBFv, transcranial Doppler), and iii. cerebrovascular function (cerebral autoregulation (CA) and cerebral vasomotor reactivity (CVMR)). To better understand potential underlying mechanisms, before and after intervention, we evaluated the effects of 3-hour sitting with and without light-intensity physical activity breaks (every 30-minutes).
RESULTS


The first wave of participants showed no change in sedentary time (n=9, 10.3±0.5 to 10.2±0.5 hours/day, P=0.87). Upon intervention optimization by participants' feedback, the subsequent participants (n=15) decreased sedentary time (10.2±0.4 to 9.2±0.3 hours/day, P<0.01). This resulted in significant increases in FMD (3.1±0.3 to 3.8±0.4%, P=0.02) and CBFv (48.4±2.6 to 51.4.±2.6 cm/s, P=0.02), without altering CA or CVMR. Before and after the 16-week intervention, 3-hour exposure to uninterrupted sitting decreased FMD and CBFv, whereas physical activity breaks prevented a decrease (both P<0.05). CA and CVMR did not change (P>0.20).
CONCLUSION


Long-term reduction in sedentary behavior improves peripheral vascular function and cerebral blood flow, and acutely prevents impaired vascular function and decreased cerebral blood flow. These results highlight the potential benefits of reducing sedentary behavior to acutely and chronically improve cardio-/cerebrovascular risk.",2020,"The first wave of participants showed no change in sedentary time (n=9, 10.3±0.5 to 10.2±0.5 hours/day, P=0.87).","['24 individuals with increased cardiovascular risk (65±5 years, 29.8±3.9 kg/m']","['reduced sitting-intervention', '3-hour sitting with and without light-intensity physical activity breaks (every 30-minutes']","['peripheral vascular function and cerebral blood flow', 'CA and CVMR', 'sedentary time', 'vascular function (flow-mediated dilation (FMD)), ii. cerebral blood flow (CBFv, transcranial Doppler', 'CBFv', 'FMD', 'cerebral blood flow', 'cerebrovascular function (cerebral autoregulation (CA) and cerebral vasomotor reactivity (CVMR', 'cardio-/cerebrovascular risk', 'risk for cardiovascular and cerebrovascular disease', 'Vascular Flow and Function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0585318', 'cui_str': 'Every thirty minutes'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0206077', 'cui_str': 'Transcranial doppler ultrasonography'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0007820', 'cui_str': 'Cerebrovascular disease'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",24.0,0.0240828,"The first wave of participants showed no change in sedentary time (n=9, 10.3±0.5 to 10.2±0.5 hours/day, P=0.87).","[{'ForeName': 'Yvonne A W', 'Initials': 'YAW', 'LastName': 'Hartman', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Laura C M', 'Initials': 'LCM', 'LastName': 'Tillmans', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Benschop', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Astrid N L', 'Initials': 'ANL', 'LastName': 'Hermans', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Kevin M R', 'Initials': 'KMR', 'LastName': 'Nijssen', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Thijs M H', 'Initials': 'TMH', 'LastName': 'Eijsvogels', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Peter H G M', 'Initials': 'PHGM', 'LastName': 'Willems', 'Affiliation': 'Department of Biochemistry, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Cees J', 'Initials': 'CJ', 'LastName': 'Tack', 'Affiliation': 'Department of Internal Medicine, Radboud Institute for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Maria T E', 'Initials': 'MTE', 'LastName': 'Hopman', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Jurgen A H R', 'Initials': 'JAHR', 'LastName': 'Claassen', 'Affiliation': 'Department of Geriatric Medicine, Donders Institute for Brain, Cognition and Behavior, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Dick H J', 'Initials': 'DHJ', 'LastName': 'Thijssen', 'Affiliation': 'Department of Physiology, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002462']
2970,32826637,Whole-Body Vibration Stimulates Microvascular Blood Flow in Skeletal Muscle.,"PURPOSE


Whole-body vibration therapy (WBV) has been reported to potentially act as an exercise mimetic by improving muscle function and exercise capacity in a variety of healthy and clinical populations. Considering the important role that microvascular blood flow plays in muscle metabolism and exercise capacity, we investigated the muscle microvascular responses of acute WBV to knee extension exercise (KEX) in healthy individuals.
METHODS


Eleven healthy adults (age: 33 ± 2 years; body mass index: 23.6 ± 1.1 kg/m) underwent 3 min of WBV, or 3 min of KEX at 25% of 1-repetition maximum, in a randomised order separated by a minimum of one week. Femoral arterial blood flow was measured via Doppler ultrasound and thigh muscle microvascular blood flow was measured via contrast enhanced ultrasound at baseline and throughout the 3-min post-intervention recovery period.
RESULTS


Both WBV and KEX significantly increased peak microvascular blood flow (WBV: 5.6-fold; KEX: 21-fold; both P <0.05) during the 3-min recovery period. Despite a similar increase in femoral arterial blood flow (~4-fold; both P<0.05 versus baseline) and whole-body oxygen consumption measured by indirect calorimetry (WBV: 48%; KEX: 60%, both P<0.05 versus baseline) in both conditions, microvascular blood flow was stimulated to a greater extent after KEX.
CONCLUSION


A single 3-min session of WBV in healthy individuals is sufficient to significantly enhance muscle microvascular blood flow. Despite KEX providing a more potent stimulus, WBV may be an effective method for improving microvascular blood flow in populations reported to exhibit microvascular dysfunction such as patients with type 2 diabetes.",2020,"Despite a similar increase in femoral arterial blood flow (~4-fold; both P<0.05 versus baseline) and whole-body oxygen consumption measured by indirect calorimetry (WBV: 48%; KEX: 60%, both P<0.05 versus baseline) in both conditions, microvascular blood flow was stimulated to a greater extent after KEX.
","['Eleven healthy adults (age: 33 ± 2 years; body mass index: 23.6 ± 1.1 kg/m) underwent 3 min of WBV, or 3 min of', 'patients with type 2 diabetes', 'healthy individuals']","['Whole-Body Vibration', 'KEX', 'knee extension exercise (KEX', 'Whole-body vibration therapy (WBV']","['microvascular blood flow', 'peak microvascular blood flow (WBV', 'femoral arterial blood flow', 'muscle microvascular blood flow', 'Femoral arterial blood flow', 'whole-body oxygen consumption']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0229665', 'cui_str': 'Arterial blood'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]",11.0,0.0206624,"Despite a similar increase in femoral arterial blood flow (~4-fold; both P<0.05 versus baseline) and whole-body oxygen consumption measured by indirect calorimetry (WBV: 48%; KEX: 60%, both P<0.05 versus baseline) in both conditions, microvascular blood flow was stimulated to a greater extent after KEX.
","[{'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Betik', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Lewan', 'Initials': 'L', 'LastName': 'Parker', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Gunveen', 'Initials': 'G', 'LastName': 'Kaur', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Glenn D', 'Initials': 'GD', 'LastName': 'Wadley', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Michelle A', 'Initials': 'MA', 'LastName': 'Keske', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002463']
2971,32826644,"Safety of KPI-121 Ophthalmic Suspension 0.25% in Patients With Dry Eye Disease: A Pooled Analysis of 4 Multicenter, Randomized, Vehicle-Controlled Studies.","PURPOSE


The safety of KPI-121 0.25%, an ophthalmic nanoparticle suspension of loteprednol etabonate, was evaluated in subjects with dry eye disease (DED) in one phase 2 and three phase 3 randomized trials of similar design.
METHODS


Adults with DED received KPI-121 0.25% or vehicle drops 4 times daily (QID) for ≥2 weeks; 1430 subjects received KPI-121 0.25% and 1438 subjects received vehicle drops. Main safety assessments were adverse events (AEs) and intraocular pressure (IOP). As a common side effect associated with the use of ocular corticosteroids is elevated IOP, subjects with a history of or current diagnosis of glaucoma were excluded.
RESULTS


Instillation site pain was the most common AE, reported by 5.2% of subjects in the KPI-121 0.25% group and 4.4% of subjects in the vehicle group; other AEs were reported by ≤0.8% of subjects in the KPI-121 group. IOP elevations, a side effect associated with the use of ophthalmic corticosteroids, were observed with low incidence: 0.6% and 0.2% of subjects in the KPI-121 and vehicle groups, respectively. An IOP elevation was defined as an increase from baseline of >5 mm Hg that resulted in an IOP of ≥21 mm Hg in either eye during use of the study product.
CONCLUSIONS


KPI-121 ophthalmic suspension 0.25% seemed to be safe and well tolerated when dosed QID for 2 to 4 weeks in those DED subjects included in the 4 trials.",2020,"RESULTS


Instillation site pain was the most common AE, reported by 5.2% of subjects in the KPI-121 0.25% group and 4.4% of subjects in the vehicle group; other AEs were reported by ≤0.8% of subjects in the KPI-121 group.","['subjects with dry eye disease (DED) in one phase 2 and three phase 3 randomized trials of similar design', 'Adults with DED received', 'Patients With Dry Eye Disease', 'subjects with a history of or current diagnosis of glaucoma were excluded']","['KPI-121 0.25% or vehicle drops 4 times daily (QID', 'KPI-121 0.25% and 1438 subjects received vehicle drops', 'KPI-121 ophthalmic suspension', 'loteprednol etabonate', 'KPI-121', 'KPI-121 Ophthalmic Suspension']","['IOP elevation', 'adverse events (AEs) and intraocular pressure (IOP', 'IOP elevations', 'safe and well tolerated']","[{'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}]","[{'cui': 'C4517443', 'cui_str': '0.25'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0991532', 'cui_str': 'Eye suspension'}, {'cui': 'C0126177', 'cui_str': 'loteprednol etabonate'}]","[{'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.301488,"RESULTS


Instillation site pain was the most common AE, reported by 5.2% of subjects in the KPI-121 0.25% group and 4.4% of subjects in the vehicle group; other AEs were reported by ≤0.8% of subjects in the KPI-121 group.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Korenfeld', 'Affiliation': 'Comprehensive Eye Care, Ltd, Washington, MO.'}, {'ForeName': 'Kelly K', 'Initials': 'KK', 'LastName': 'Nichols', 'Affiliation': 'School of Optometry, University of Alabama, Birmingham, AL.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Goldberg', 'Affiliation': 'Wolstan and Goldberg Eye Associates, Torrance, CA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Evans', 'Affiliation': 'Total Eye Care, PA, Memphis, TN.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Sall', 'Affiliation': 'Sall Research Medical Center, Artesia, CA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Foulks', 'Affiliation': ''}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Coultas', 'Affiliation': 'Kala Pharmaceuticals, Inc, Watertown, MA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Brazzell', 'Affiliation': 'Kala Pharmaceuticals, Inc, Watertown, MA.'}]",Cornea,['10.1097/ICO.0000000000002452']
2972,32826657,Incidence Rates of Interstitial Lung Disease Events in Tofacitinib-Treated Rheumatoid Arthritis Patients: Post Hoc Analysis From 21 Clinical Trials.,"BACKGROUND/OBJECTIVE


Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Interstitial lung disease (ILD) is an extra-articular manifestation of RA. We investigated incidence rates of ILD in patients with RA, receiving tofacitinib 5 or 10 mg twice daily, and identified potential risk factors for ILD.
METHODS


This post hoc analysis comprised a pooled analysis of patients receiving tofacitinib 5 or 10 mg twice daily or placebo from 2 phase (P)1, 10 P2, 6 P3, 1 P3b/4, and 2 long-term extension studies. Interstitial lung disease events were adjudicated as ""probable"" (supportive clinical evidence) or ""possible"" (no supportive clinical evidence) compatible adverse events. Incidence rates (patients with events per 100 patient-years) were calculated for ILD events.
RESULTS


Of 7061 patients (patient-years of exposure = 23,393.7), 42 (0.6%) had an ILD event; median time to ILD event was 1144 days. Incidence rates for ILD with both tofacitinib doses were 0.18 per 100 patient-years. Incidence rates generally remained stable over time. There were 17 of 42 serious adverse events (40.5%) of ILD; for all ILD events (serious and nonserious), 35 of 42 events (83.3%) were mild to moderate in severity. A multivariable Cox regression analysis identified age 65 years or older (hazard ratio 2.43 [95% confidence interval, 1.13-5.21]), current smokers (2.89 [1.33-6.26]), and Disease Activity Score in 28 joints-erythrocyte sedimentation rate score (1.30 [1.04-1.61]) as significant risk factors for ILD events.
CONCLUSIONS


Across P1/2/3/4/long-term extension studies, incidence rates for ILD events were 0.18 following tofacitinib treatment, and ILD events were associated with known risk factors for ILD in RA.",2020,"There were 17 of 42 serious adverse events (40.5%) of ILD; for all ILD events (serious and nonserious), 35 of 42 events (83.3%) were mild to moderate in severity.","['7061 patients (patient-years of exposure = 23,393.7), 42 (0.6%) had an ILD event; median time to ILD event was 1144 days', 'Treated Rheumatoid Arthritis Patients', 'patients with RA']","['tofacitinib 5 or 10 mg twice daily or placebo', 'Tofacitinib']","['Incidence rates', 'serious adverse events', 'Disease Activity Score in 28 joints-erythrocyte sedimentation rate score', 'incidence rates for ILD events', 'incidence rates of ILD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",7061.0,0.309477,"There were 17 of 42 serious adverse events (40.5%) of ILD; for all ILD events (serious and nonserious), 35 of 42 events (83.3%) were mild to moderate in severity.","[{'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Citera', 'Affiliation': 'From the Instituto de Rehabilitación Psicofísica.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Mysler', 'Affiliation': 'Organización Médica de Investigación, Buenos Aires, Argentina.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Madariaga', 'Affiliation': 'Clínica del Sur, Arequipa, Peru.'}, {'ForeName': 'Mario H', 'Initials': 'MH', 'LastName': 'Cardiel', 'Affiliation': 'Centro de Investigación Clínica de Morelia, Morelia, Mexico.'}, {'ForeName': 'Oswaldo', 'Initials': 'O', 'LastName': 'Castañeda', 'Affiliation': 'Clínica Anglo Americana, Lima, Peru.'}, {'ForeName': 'Aryeh', 'Initials': 'A', 'LastName': 'Fischer', 'Affiliation': 'Department of Medicine, University of Colorado, Denver, CO.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Richette', 'Affiliation': 'Department of Rheumatology, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Chartrand', 'Affiliation': 'Department of Medicine, Hôpital Maisonneuve-Rosemont Affiliated to Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Jin Kyun', 'Initials': 'JK', 'LastName': 'Park', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'Strengholt', 'Affiliation': 'Pfizer Inc., Capelle aan den IJssel, the Netherlands.'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Rivas', 'Affiliation': 'Pfizer SLU, Madrid, Spain.'}, {'ForeName': 'Amit V', 'Initials': 'AV', 'LastName': 'Thorat', 'Affiliation': 'Pfizer Australia, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Girard', 'Affiliation': 'Pfizer Inc., Montreal, Quebec, Canada.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kwok', 'Affiliation': 'Pfizer Inc., New York, NY.'}, {'ForeName': 'Lisy', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Pfizer Inc., Groton, CT.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Ponce de Leon', 'Affiliation': 'Pfizer Inc., Lima, Peru.'}]",Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases,['10.1097/RHU.0000000000001552']
2973,32826778,A Brief Report on an 8-Week Course of Mindfulness-based Care for Chronic Pain in the Treatment of Veterans With Back Pain: Barriers Encountered to Treatment Engagement and Lessons Learned.,"BACKGROUND


Chronic pain and associated symptoms are debilitating for veterans. Medical costs of treatments are high and current treatment options, most notably with opioid medications, have been associated with significant risk. Mindfulness-based interventions appear promising for chronic pain, but require additional testing in veteran care settings.
OBJECTIVE


This project was designed to test the feasibility of engaging and retaining veterans with chronic lower back pain in a new mindfulness protocol tailored for veterans, mindfulness-based care for chronic pain (MBCP). Clinical outcomes were also assessed.
DESIGN


An open pilot trial of an 8-week MBCP course that included meditation, gentle yoga, and psychoeducation.
SUBJECTS


Twenty-two veterans (mean age=49.77; 18% women) were recruited from a VA Medical Center in the Northeastern US. After screening for inclusion/exclusion criteria, 20 were eligible at baseline.
MEASURES


Veterans were assessed at baseline and postintervention for functional impairment, pain intensity and bothersomeness, depression, and mindfulness.
RESULTS


The average number of sessions completed was 5; only 4 (20%) attended all sessions. Eleven of the 20 participants (55%) attended 5 or more sessions and had complete preintervention and postintervention visits. Five of the 11 had a clinically meaningful decrease in pain intensity and in depressive symptoms, while 6 of 11 had a meaningful decrease in pain bothersomeness and functional impairment.
CONCLUSIONS


It was challenging to enroll and retain participants in this study, even with our intervention designed for veterans. We discuss possible adaptations and refinements in MBCP for veterans with chronic pain to enhance feasibility and improve upon these interventions.",2020,Eleven of the 20 participants (55%) attended 5 or more sessions and had complete preintervention and postintervention visits.,"['Twenty-two veterans (mean age=49.77; 18% women) were recruited from a VA Medical Center in the Northeastern US', 'veterans, mindfulness-based care for chronic pain (MBCP', 'Veterans With Back Pain', 'Eleven of the 20 participants (55%) attended 5 or more sessions and had complete preintervention and postintervention visits', 'veterans with chronic pain']","['Mindfulness-based Care', 'MBCP course that included meditation, gentle yoga, and psychoeducation']","['pain bothersomeness and functional impairment', 'functional impairment, pain intensity and bothersomeness, depression, and mindfulness', 'pain intensity and in depressive symptoms']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0468803,Eleven of the 20 participants (55%) attended 5 or more sessions and had complete preintervention and postintervention visits.,"[{'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Eaton', 'Affiliation': 'Mental Health and Behavioral Sciences Service, Department of Veteran Affairs Medical Center, Providence VA Medical Center.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Swearingen', 'Affiliation': 'Department of Veteran Affairs Medical Center, Center for Neurorestoration and Neurotechnology.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Zand Vakili', 'Affiliation': 'Mental Health and Behavioral Sciences Service, Department of Veteran Affairs Medical Center, Providence VA Medical Center.'}, {'ForeName': 'Stephanie R', 'Initials': 'SR', 'LastName': 'Jones', 'Affiliation': 'Department of Veteran Affairs Medical Center, Center for Neurorestoration and Neurotechnology.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Greenberg', 'Affiliation': 'Mental Health and Behavioral Sciences Service, Department of Veteran Affairs Medical Center, Providence VA Medical Center.'}]",Medical care,['10.1097/MLR.0000000000001377']
2974,32826784,Cost-effectiveness of Yoga for Chronic Low Back Pain in Veterans.,"BACKGROUND


Yoga interventions can improve function and reduce pain in persons with chronic low back pain (cLBP).
OBJECTIVE


Using data from a recent trial of yoga for military veterans with cLBP, we analyzed the incremental cost-effectiveness of yoga compared with usual care.
METHODS


Participants (n=150) were randomized to either 2× weekly, 60-minute yoga sessions for 12 weeks, or to delayed treatment (DT). Outcomes were measured at 12 weeks, and 6 months. Quality-adjusted life years (QALYs) were measured using the EQ-5D scale. A 30% improvement on the Roland-Morris Disability Questionnaire (primary outcome) served as an additional effectiveness measure. Intervention costs including personnel, materials, and transportation were tracked during the study. Health care costs were obtained from patient medical records. Health care organization and societal perspectives were examined with a 12-month horizon.
RESULTS


Incremental QALYs gained by the yoga group over 12 months were 0.043. Intervention costs to deliver yoga were $307/participant. Negligible differences in health care costs were found between groups. From the health care organization perspective, the incremental cost-effectiveness ratio to provide yoga was $4488/QALY. From the societal perspective, yoga was ""dominant"" providing both health benefit and cost savings. Probabilistic sensitivity analysis indicates an 89% chance of yoga being cost-effective at a willingness-to-pay of $50,000. A scenario comparing the costs of yoga and physical therapy suggest that yoga may produce similar results at a much lower cost.
DISCUSSION/CONCLUSIONS


Yoga is a cost-effective treatment for reducing pain and disability among military veterans with cLBP.",2020,Negligible differences in health care costs were found between groups.,"['Veterans', 'military veterans with cLBP', 'Participants (n=150', 'persons with chronic low back pain (cLBP']",[],"['Roland-Morris Disability Questionnaire', 'Health care costs', 'pain and disability', 'EQ-5D scale', 'health care costs', 'Quality-adjusted life years (QALYs']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",150.0,0.0429254,Negligible differences in health care costs were found between groups.,"[{'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Groessl', 'Affiliation': 'Health Services Research and Development, VA San Diego Healthcare System, San Diego.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Health Services Research and Development, VA San Diego Healthcare System, San Diego.'}, {'ForeName': 'Erin L', 'Initials': 'EL', 'LastName': 'Richard', 'Affiliation': 'Health Services Research and Development, VA San Diego Healthcare System, San Diego.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Tally', 'Affiliation': 'Department of Family Medicine and Public Health, University of California San Diego, La Jolla, CA.'}]",Medical care,['10.1097/MLR.0000000000001356']
2975,32826829,Effects of a 14-Day High-Intensity Shock Microcycle in High-Level Ice Hockey Players' Fitness.,"Brocherie, F, Perez, J, and Guilhem, G. Effects of a 14-day high-intensity shock microcycle in high-level ice hockey players' fitness. J Strength Cond Res XX(X): 000-000, 2020-Elite athletes face congested schedules with increased competition frequency and restricted time for training periods. Therefore, time is lacking to design long-term sport-specific block periodization. This study aimed to investigate the effects of adding a 14-day off-ice high-intensity training (HIT) shock microcycle to the usual training content of the pre-season preparation of high-level male ice hockey players' fitness. Fourteen players were randomly assigned to off-ice HIT (n = 7) or usual pre-season training (control, n = 7). For the HIT group, additional off-ice training content included 2 sessions of repeated-maximal resistance training, 2 sessions of repeated-sprint training, and 2 sessions of high-intensity intermittent training. Control group performed equal number of off-ice sessions using traditional strength and conditioning training. Off-ice Yo-Yo intermittent recovery test level 2 (YYIR2) and on-ice repeated-sprint ability test (RSA) were conducted before (pre-test) and 3 days after the intervention (post-test). Statistical significance was set at p < 0.05. Significant group × time interactions were found for off-ice YYIR2 performance (p < 0.05) and on-ice RSA-cumulated skating time (RSATT; p < 0.05). Compared with pre-test, off-ice YYIR2 distance covered significantly increased (from 708.6 ± 97.2 to 885.7 ± 118.7 m, p < 0.01; +25.8 ± 16.9%, p < 0.05) and on-ice RSATT significantly decreased (from 28.35 ± 0.87 to 28.14 ± 0.84 seconds; -1.7 ± 2.1%, both p < 0.05)] for HIT group. No significant pre-test to post-test changes were found for the control group (+2.7 ± 20.0% for YYIR2 and +0.9 ± 2.2% for RSATT). The implementation of a 14-day shock microcycle (including 6 HIT sessions) significantly improved fitness performance in high-level male ice hockey players. Such HIT block periodization offers a promising way to deal with congested schedules.",2020,Significant group × time interactions were found for off-ice YYIR2 performance (p < 0.05) and on-ice RSA-cumulated skating time (RSATT; p < 0.05).,"['high-level male ice hockey players', 'Fourteen players', ""High-Level Ice Hockey Players' Fitness"", ""high-level male ice hockey players' fitness""]","['J Strength Cond Res XX(X', 'Control group performed equal number of off-ice sessions using traditional strength and conditioning training', 'ice high-intensity training (HIT) shock microcycle', 'repeated-maximal resistance training, 2 sessions of repeated-sprint training, and 2 sessions of high-intensity intermittent training', 'Off-ice Yo-Yo intermittent recovery test level 2 (YYIR2) and on-ice repeated-sprint ability test (RSA', 'usual pre-season training', '14-Day High-Intensity Shock Microcycle']",['fitness performance'],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0020748', 'cui_str': 'Ice hockey'}, {'cui': 'C3715152', 'cui_str': '14'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0020746', 'cui_str': 'Ice'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0454374', 'cui_str': 'Sprint training'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",[],14.0,0.0191571,Significant group × time interactions were found for off-ice YYIR2 performance (p < 0.05) and on-ice RSA-cumulated skating time (RSATT; p < 0.05).,"[{'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Brocherie', 'Affiliation': 'Laboratory Sport, Expertise and Performance (EA 7370), French Institute of Sport (INSEP), Paris, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Perez', 'Affiliation': 'Laboratory Sport, Expertise and Performance (EA 7370), French Institute of Sport (INSEP), Paris, France.'}, {'ForeName': 'Gaël', 'Initials': 'G', 'LastName': 'Guilhem', 'Affiliation': 'Laboratory Sport, Expertise and Performance (EA 7370), French Institute of Sport (INSEP), Paris, France.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003769']
2976,32826830,Acute and Long-Term Comparison of Fixed vs. Self-Selected Rest Interval Between Sets on Upper-Body Strength.,"Simão, R, Polito, M, de Salles, BF, Marinho, DA, Garrido, ND, Santos Junior, ERT, and Willardson, JM. Acute and long-term comparison of fixed vs. self-selected rest interval between sets on upper-body strength. J Strength Cond Res XX(X): 000-000, 2020-The effects of different rest interval durations between sets has been widely studied, but only recently, the self-selected rest interval (SSRI) has been a matter of interest. However, previous studies comparing fixed and SSRI have investigated only acute responses. The purpose of this study was to analyze the acute and long-term effects of a fixed rest interval (FRI) vs. an SSRI between sets on upper-body performance and strength gains. Thirty-three trained men were randomly divided into 2 groups: FRI (75 seconds between sets), and SSRI. Both groups performed 3 sets with 75% of 1-repetition maximum until repetition failure in the chest press (CP), lat pull-down (LPD), shoulder press (SP), and seated row (SR) 3 times a week for 8 weeks. The results demonstrated that the SSRI allowed for significantly greater repetition performance vs. the FRI in the CP (26.1 ± 2.0 vs. 21.5 ± 1.8), LPD (30.1 ± 2.3 vs. 24.9 ± 1.9), SP (24.0 ± 2.8 vs. 17.4 ± 1.5), and SR (26.3 ± 1.6 vs. 22.0 ± 1.6). In addition, the following strength gains were observed: SSRI (CP: 6.8%, LPD: 8.0%, SP: 6.7%, SR: 7.8%) and FRI (CP: 7.4%, LPD: 6.7%, SP: 6.1%, SR: 7.0%) without significant differences between the groups. In conclusion, within an 8-week period, both protocols seem to be effective for strength gains, despite the higher training volume accomplished by the SSRI group. However, the FRI was 37% more time efficient.",2020,"The results demonstrated that the SSRI allowed for significantly greater repetition performance vs. the FRI in the CP (26.1 ± 2.0 vs. 21.5 ± 1.8), LPD (30.1 ± 2.3 vs. 24.9 ± 1.9), SP (24.0 ± 2.8 vs. 17.4 ± 1.5), and SR (26.3 ± 1.6 vs. 22.0 ± 1.6).",['Thirty-three trained men'],"['fixed rest interval (FRI', 'Fixed vs. Self-Selected Rest Interval', 'fixed vs. self-selected rest interval', 'J Strength Cond Res XX(X']","['Simão, R, Polito, M, de Salles, BF, Marinho, DA, Garrido, ND, Santos Junior, ERT, and Willardson, JM', 'repetition performance', 'FRI']","[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}]","[{'cui': 'C0014935', 'cui_str': 'Oestrogen replacement therapy'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",33.0,0.0121402,"The results demonstrated that the SSRI allowed for significantly greater repetition performance vs. the FRI in the CP (26.1 ± 2.0 vs. 21.5 ± 1.8), LPD (30.1 ± 2.3 vs. 24.9 ± 1.9), SP (24.0 ± 2.8 vs. 17.4 ± 1.5), and SR (26.3 ± 1.6 vs. 22.0 ± 1.6).","[{'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Simão', 'Affiliation': 'Strength Training Laboratory, Universidade Federal do Rio de janeiro, UFRJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Polito', 'Affiliation': 'Physical Education Department, UEL, Paraná, Brazil.'}, {'ForeName': 'Belmiro', 'Initials': 'B', 'LastName': 'Freitas de Salles', 'Affiliation': 'Strength Training Laboratory, Universidade Federal do Rio de janeiro, UFRJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'Daniel Almeida', 'Initials': 'DA', 'LastName': 'Marinho', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), UBI, Covilhã, Portugal.'}, {'ForeName': 'Nuno D', 'Initials': 'ND', 'LastName': 'Garrido', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development (CIDESD), UBI, Covilhã, Portugal.'}, {'ForeName': 'Evaldo Rui Tavares Santos', 'Initials': 'ERTS', 'LastName': 'Junior', 'Affiliation': 'Strength Training Laboratory, Universidade Federal do Rio de janeiro, UFRJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Willardson', 'Affiliation': 'Health and Human Performance Department, Montana State University Billings, Billings, Montana.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003606']
2977,32826832,The Impact of Recovery Time on Performance in Division I Collegiate Beach Volleyball Players.,"Holtgeerts, RN, Gann, J, Jung, HC, and Hey, W. The impact of recovery time on performance in Division I collegiate beach volleyball players. J Strength Cond Res XX(X): 000-000, 2020-The sport of beach volleyball has recently grown significantly at the collegiate level, and collegiate beach volleyball players often practice and compete 5 or 6 days per week during the competitive season. This study examined the effects of the amount of recovery time on performance in Division 1 Collegiate beach volleyball players. Ten female NCAA Division 1 beach volleyball players, aged 20.2 ± 1.23 years, participated in the study. Subjects completed 2 trials consisting of 4 sessions of volleyball play (with a 24-hour recovery trial and 48-hour recovery trial). Trials were randomized and counter balanced. Each trial measured counter-movement jump, 5-10-5 agility time, 3 beach volleyball drills, and scores of a beach volleyball match. Perceived recovery, sleep quality, and rating of perceived exertion were also recorded. The significance level set for the study was p ≤ 0.05. Counter-movement jump showed small but significant increases following the 24-hour recovery period (p ≤ 0.05). 5-10-5 agility test showed significant improvement with the 48-hour recovery period (p ≤ 0.05). Perceived Recovery scores demonstrated significant increases in both recovery periods (p ≤ 0.05). Beach volleyball drill and match performance were not affected by the change in recovery time. These results indicate that, although some physical skills are affected by recovery time, beach volleyball performance as a whole is relatively stable over several days. It is normal for NCAA athletes to play back-to-back days and with little recovery time, and these results indicate that this practice does not negatively affect sport performance.",2020,Counter-movement jump showed small but significant increases following the 24-hour recovery period (p ≤ 0.05).,"['Ten female NCAA Division 1 beach volleyball players, aged 20.2 ± 1.23 years, participated in the study', 'Division 1 Collegiate beach volleyball players', 'Division I collegiate beach volleyball players', 'Division I Collegiate Beach Volleyball Players']",[],"['Perceived recovery, sleep quality, and rating of perceived exertion', 'agility time, 3 beach volleyball drills, and scores of a beach volleyball match', 'Holtgeerts, RN, Gann, J, Jung, HC, and', 'Beach volleyball drill and match performance', 'recovery time, beach volleyball performance']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1293097', 'cui_str': 'Division'}, {'cui': 'C0331781', 'cui_str': 'Beach'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C4517642', 'cui_str': '20.2'}, {'cui': 'C4517495', 'cui_str': '1.23'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0331781', 'cui_str': 'Beach'}, {'cui': 'C1956059', 'cui_str': 'Volleyball'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]",10.0,0.0711588,Counter-movement jump showed small but significant increases following the 24-hour recovery period (p ≤ 0.05).,"[{'ForeName': 'Rebecca N', 'Initials': 'RN', 'LastName': 'Holtgeerts', 'Affiliation': 'Department of Kinesiology, University of Louisiana-Monroe, Monroe, Louisiana.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Gann', 'Affiliation': 'Department of Kinesiology, University of Louisiana-Monroe, Monroe, Louisiana.'}, {'ForeName': 'Hyun Chul', 'Initials': 'HC', 'LastName': 'Jung', 'Affiliation': 'Department of Coaching, College of Physical Education, Kyung Hee University-Global Campus, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hey', 'Affiliation': 'Department of Kinesiology, University of Louisiana-Monroe, Monroe, Louisiana.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003754']
2978,32827122,"Effects of nasal high flow on sympathovagal balance, sleep, and sleep-related breathing in patients with precapillary pulmonary hypertension.","BACKGROUND


In precapillary pulmonary hypertension (PH), nasal high flow therapy (NHF) may favorably alter sympathovagal balance (SVB) and sleep-related breathing through washout of anatomical dead space and alleviation of obstructive sleep apnea (OSA) due to generation of positive airway pressure.
OBJECTIVES


To investigate the effects of NHF on SVB, sleep, and OSA in patients with PH, and compare them with those of positive airway pressure therapy (PAP).
METHODS


Twelve patients with PH (Nice class I or IV) and confirmed OSA underwent full polysomnography, and noninvasive monitoring of SVB parameters (spectral analysis of heart rate, diastolic blood pressure variability). Study nights were randomly split into four 2-h segments with no treatment, PAP, NHF 20 L/min, or NHF 50 L/min. In-depth SVB analysis was conducted on 10-min epochs during daytime and stable N2 sleep at nighttime.
RESULTS


At daytime and compared with no treatment, NHF20 and NHF50 were associated with a flow-dependent increase in peripheral oxygen saturation but a shift in SVB towards increased sympathetic drive. At nighttime, NHF20 was associated with increased parasympathetic drive and improvements in sleep efficiency, but did not alter OSA severity. NHF50 was poorly tolerated. PAP therapy improved OSA but had heterogenous effects on SVB and neutral effects on sleep outcomes. Hemodynamic effects were neutral for all interventions.
CONCLUSIONS


In sleeping PH patients with OSA NHF20 but not NHF50 leads to decreased sympathetic drive likely due to washout of anatomical dead space. NHF was not effective in lowering the apnea-hypopnoea index and NHF50 was poorly tolerated.",2020,"At daytime and compared with no treatment, NHF20 and NHF50 were associated with a flow-dependent increase in peripheral oxygen saturation but a shift in SVB towards increased sympathetic drive.","['patients with precapillary pulmonary hypertension', 'patients with PH, and compare them with those of positive airway pressure therapy (PAP', 'Twelve patients with PH (Nice class I or IV) and']","['PAP, NHF 20 L/min, or NHF 50 L/min', 'nasal high flow therapy (NHF', 'PAP therapy', 'NHF', 'confirmed OSA', 'NHF50']","['OSA severity', 'Hemodynamic effects', 'parasympathetic drive and improvements in sleep efficiency', 'sympathovagal balance, sleep, and sleep-related breathing', 'peripheral oxygen saturation', 'SVB and neutral effects on sleep outcomes', 'SVB parameters (spectral analysis of heart rate, diastolic blood pressure variability', 'SVB, sleep, and OSA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3696954', 'cui_str': 'Precapillary pulmonary hypertension'}, {'cui': 'C0020542', 'cui_str': 'Pulmonary hypertension'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0721912', 'cui_str': ""N'ICE""}, {'cui': 'C0441885', 'cui_str': 'Class 1'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]","[{'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}]",12.0,0.0183373,"At daytime and compared with no treatment, NHF20 and NHF50 were associated with a flow-dependent increase in peripheral oxygen saturation but a shift in SVB towards increased sympathetic drive.","[{'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Spiesshoefer', 'Affiliation': 'Department of Neurology with Institute for Translational Neurology, University of Muenster, Muenster, Germany. j.spiesshoefer@santannapisa.it.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Bannwitz', 'Affiliation': 'Department of Neurology with Institute for Translational Neurology, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mohr', 'Affiliation': 'Department of Medicine A, Hematology, Oncology and Pulmonary Medicine, University Hospital Muenster, Muenster, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Herkenrath', 'Affiliation': 'Bethanien Hospital gGmbH Solingen, Solingen, Germany and Institute for Pneumology at the University of Cologne, Solingen, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Randerath', 'Affiliation': 'Bethanien Hospital gGmbH Solingen, Solingen, Germany and Institute for Pneumology at the University of Cologne, Solingen, Germany.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Sciarrone', 'Affiliation': 'Cardiology and Cardiovascular Medicine Division, Fondazione Toscana Gabriele Monasterio, National Research Council, CNR-Regione Toscana, Pisa, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiedemann', 'Affiliation': 'Department of Neurology with Institute for Translational Neurology, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Schneider', 'Affiliation': 'Sleep Disorders Center, Bayview Hospital, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Braun', 'Affiliation': 'Division of Allergy, Pulmonary and Critical Care, Department of Medicine, University of Wisconsin, Madison, WI, USA.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Emdin', 'Affiliation': ""Institute of Life Sciences, Scuola Superiore Sant'Anna, Piazza Martiri della Libertà, 33, 56127, Pisa, PI, Italy.""}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Passino', 'Affiliation': ""Institute of Life Sciences, Scuola Superiore Sant'Anna, Piazza Martiri della Libertà, 33, 56127, Pisa, PI, Italy.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dreher', 'Affiliation': 'Department of Pneumology and Intensive Care Medicine, University Hospital RWTH, Aachen, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Boentert', 'Affiliation': 'Department of Neurology with Institute for Translational Neurology, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Giannoni', 'Affiliation': ""Institute of Life Sciences, Scuola Superiore Sant'Anna, Piazza Martiri della Libertà, 33, 56127, Pisa, PI, Italy.""}]",Sleep & breathing = Schlaf & Atmung,['10.1007/s11325-020-02159-1']
2979,32827193,Is antibiotics prescription needed in infants with topical corticosteroids treatment for moderate-to-severe atopic dermatitis?,"BACKGROUND


The cutaneous microbiota responses to skin health as well as atopic dermatitis OBJECTIVES: To reveal the microbiota effect in atopic dermatitis children under therapy with topical corticosteroids and antibiotics MATERIALS & METHODS: 59 atopic dermatitis patients were randomized to two treatment groups (by corticosteroids or combination therapy) in Beijing Children's Hospital. The lesion microbial samples were collected for 16S rDNA sequencing and bioinformatics analysis RESULTS: After treatment, 57 patients recovered significantly. Though topical antibiotics application blocked the restoration of commensal Streptococcus, no remarkable differences of cutaneous microbiota were identified between the two groups along the treatment. In subject 1081, who received the combination therapy, the Streptococcus and Pseudomonas as well as Chryseobacterium increased dramatically. On the contrary, the Staphylococcus aureus decreased sharply in subject 1107 with topical corticosteroids treatment CONCLUSION: Our preliminary study suggested the necessity to consider cutaneous microbiota profile when prescribing antibiotics. This article is protected by copyright. All rights reserved.",2020,"Though topical antibiotics application blocked the restoration of commensal Streptococcus, no remarkable differences of cutaneous microbiota were identified between the two groups along the treatment.","['atopic dermatitis children', 'infants with topical corticosteroids treatment for moderate-to-severe atopic dermatitis', '59 atopic dermatitis patients']",['corticosteroids or combination therapy'],"['restoration of commensal Streptococcus', 'cutaneous microbiota']","[{'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0542329', 'cui_str': 'Commensal parasite'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}]",1107.0,0.0319207,"Though topical antibiotics application blocked the restoration of commensal Streptococcus, no remarkable differences of cutaneous microbiota were identified between the two groups along the treatment.","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Computer Science, City University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Wenkui', 'Initials': 'W', 'LastName': 'Dai', 'Affiliation': 'Department of Microbial Research, WeHealthGene Institute, Shenzhen, China.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': ""Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ""Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}, {'ForeName': 'Yinhu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Computer Science, City University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chunping', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': ""Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}, {'ForeName': 'Dongfang', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Department of Microbial Research, WeHealthGene Institute, Shenzhen, China.'}, {'ForeName': 'Yunzhu', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ""Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Jiao', 'Affiliation': ""Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}, {'ForeName': 'Yawei', 'Initials': 'Y', 'LastName': 'Bian', 'Affiliation': ""Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}, {'ForeName': 'Shuaicheng', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Computer Science, City University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Yiwei', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, U.S.A.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': ""Department of Dermatology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, China.""}]",Dermatologic therapy,['10.1111/dth.14215']
2980,32827200,Effect of the exercise programme on the quality of life of prostate cancer survivors: A randomized controlled trial.,"AIM


The aim of this study was to investigate the effect of the exercise programme on the quality of life of prostate cancer (PCa) survivors.
METHODS


A randomized controlled, parallel trial was conducted from April 2017 to January 2018 on 80 PCa survivors. They were randomly assigned to intervention and control groups (n = 40 in each group). The exercise programme was designed based on the self-management approach (SMA). The intervention group participated in a 12-week exercise programme consisting of one session of group exercise and three sessions of individual exercise per week using exercise facilities in the community. Data were collected using the quality of life questionnaires and the follow-up checklist.
RESULTS


In the intervention group, statistically significant improvements in physical, role, emotional, social and sexual functions were reported. Also, the patients in this group reported reduced fatigue, insomnia, constipation, diarrhoea, urinary, bowel and hormonal treatment-related symptoms in comparison with before the exercise programme (p < 0.05).
CONCLUSIONS


Nurses are suggested to plan for improving the participation of PCa survivors in exercise programmes using exercise facilities in the community in order to reduce the complications of treatment and improve their quality of life.",2020,"Also, the patients in this group reported reduced fatigue, insomnia, constipation, diarrhoea, urinary, bowel and hormonal treatment-related symptoms in comparison with before the exercise programme (p < 0.05).
","['April 2017 to January 2018 on 80 PCa survivors', 'prostate cancer survivors']","['exercise programme consisting of one session of group exercise and three sessions of individual exercise per week using exercise facilities', 'exercise programme']","['quality of life', 'physical, role, emotional, social and sexual functions', 'reduced fatigue, insomnia, constipation, diarrhoea, urinary, bowel and hormonal treatment-related symptoms', 'quality of life of prostate cancer (PCa) survivors', 'quality of life questionnaires']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0203986', 'cui_str': 'Individual exercises'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0459299,"Also, the patients in this group reported reduced fatigue, insomnia, constipation, diarrhoea, urinary, bowel and hormonal treatment-related symptoms in comparison with before the exercise programme (p < 0.05).
","[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Mardani', 'Affiliation': 'Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shadan', 'Initials': 'S', 'LastName': 'Pedram Razi', 'Affiliation': 'Faculty of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Mazaheri', 'Affiliation': 'Department of Sports and Exercise Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shima', 'Initials': 'S', 'LastName': 'Haghani', 'Affiliation': 'Nursing Care Research Center, School of Nursing and Midwifery, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Vaismoradi', 'Affiliation': 'Faculty of Nursing and Health Sciences, Nord University, Bodø, Norway.'}]",International journal of nursing practice,['10.1111/ijn.12883']
2981,32826776,Tailored to Fit: How an Implementation Framework Can Support Pragmatic Pain Care Trial Adaptation for Diverse Veterans Affairs Clinical Settings.,"BACKGROUND


Veterans Affairs (VA) has rolled out a holistic, multicomponent Whole Health care model nationwide, yet no pragmatic trials have been conducted in real-world clinical settings to compare its effectiveness against other evidence-based approaches for chronic pain management in veterans.
OBJECTIVES


We describe the adaptation of the first large pragmatic randomized controlled trial of the Whole Health model for chronic pain care for diverse VA clinical settings.
RESEARCH DESIGN


Informed by the Promoting Action on Research Implementation in Health Systems implementation framework, we conducted qualitative semistructured interviews to obtain feedback on trial design from VA leadership, frontline clinicians, and veterans with chronic pain at 5 VA enrollment sites. Next, we convened in-person evidence-based quality improvement (EBQI) meetings with study stakeholders (including frontline clinicians and administrators) at each site to discuss study design; review interview themes; and identify site-specific barriers, facilitators, and approaches to implementation. Ethnographic observations from EBQI meetings provided additional insight into implementation strategies.
SUBJECTS


Seventy-four veteran and VA staff stakeholders were interviewed; 71 stakeholders participated in EBQI meetings.
RESULTS


At each site, unique clinical contexts and varying resources for Whole Health and pain care delivery affected plans for trial implementation. We present examples of local adaptations that emerged through the formative evaluation process to facilitate implementation and yield a more pragmatic trial design.
CONCLUSIONS


A systematic formative evaluation can facilitate engagement and buy-in of study stakeholders. Locally tailored pragmatic implementation strategies may improve the likelihood of successful trial execution as well as future implementation of evidence-based pain care approaches in real-world clinical settings.",2020,Locally tailored pragmatic implementation strategies may improve the likelihood of successful trial execution as well as future implementation of evidence-based pain care approaches in real-world clinical settings.,['Seventy-four veteran and VA staff stakeholders were interviewed; 71 stakeholders participated in EBQI meetings'],[],[],"[{'cui': 'C4517867', 'cui_str': '74'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]",[],[],,0.194153,Locally tailored pragmatic implementation strategies may improve the likelihood of successful trial execution as well as future implementation of evidence-based pain care approaches in real-world clinical settings.,"[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Purcell', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Becker', 'Affiliation': 'VA Connecticut Healthcare System, West Haven.'}, {'ForeName': 'Kara A', 'Initials': 'KA', 'LastName': 'Zamora', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'McGrath', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Hildi J', 'Initials': 'HJ', 'LastName': 'Hagedorn', 'Affiliation': 'Minneapolis VA Health Care System.'}, {'ForeName': 'Eva R', 'Initials': 'ER', 'LastName': 'Fabian', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'McCamish', 'Affiliation': 'San Francisco VA Health Care System.'}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Seal', 'Affiliation': 'San Francisco VA Health Care System.'}]",Medical care,['10.1097/MLR.0000000000001376']
2982,32826835,"A 3-Week, Low-Carbohydrate, High-Fat Diet Improves Multiple Serum Inflammatory Markers in Endurance-Trained Males.","Waldman, HS, Heatherly, AJ, Killen, LG, Hollingsworth, A, Koh, Y, and O'Neal, EK. A three-week, low-carbohydrate, high-fat diet improves multiple serum inflammatory markers in endurance-trained males. J Strength Cond Res XX(X): 000-000, 2020-This study examined the effects of a low-carbohydrate, high-fat diet (LCHF) on inflammatory marker responses in middle-aged endurance athletes. Eight male runners maintained their habitual mixed diet (HMD) in the first phase of the study before switching to a noncalorically restricted LCHF diet (∼70% of kcals from fat; carbohydrate <50 g) for 3 weeks. Subjects completed a 50-minute fixed pace treadmill running protocol in a hot environment, followed by a 5-km outdoor time trial. Fasting serum samples were collected immediately after exercise and heat stress restriction, and again 24 hours after the exercise/heat stressor. Thirty inflammation markers were assessed using the multiplex flow immunoassay technique. Seven markers (BAFF/TNFSF-13, sCD30/TNFRSF8, sCD163, Chitinase3-like1, gp130SIL-6Rβ, sTNFR-1, and sTNFR-2) reached statistical significance (p < 0.05) favoring LCHF before exercise, and sCD30/TNFRSF8 favored (p < 0.05) LCHF before (HMD = 459 ± 111; LCHF = 296 ± 100) and after (HMD = 385 ± 104; LCHF = 285 ± 104 pg·ml) exercise. Although the current dietary intervention was short in duration, LCHF seems to offer some protection against multiple chronic inflammation markers for physically active men between ages 30 and 50 years.",2020,"Seven markers (BAFF/TNFSF-13, sCD30/TNFRSF8, sCD163, Chitinase3-like1, gp130SIL-6Rβ, sTNFR-1, and sTNFR-2) reached statistical significance (p < 0.05) favoring LCHF before exercise, and sCD30/TNFRSF8 favored (p < 0.05) LCHF before (HMD = 459 ± 111; LCHF = 296 ± 100) and after (HMD = 385 ± 104; LCHF = 285 ± 104 pg·ml) exercise.","['Eight male runners maintained their', ' 000-000', 'middle-aged endurance athletes', 'endurance-trained males', 'physically active men between ages 30 and 50 years', 'Endurance-Trained Males']","['J Strength Cond Res XX(X', 'Low-Carbohydrate, High-Fat Diet', 'habitual mixed diet (HMD', 'low-carbohydrate, high-fat diet (LCHF', 'low-carbohydrate, high-fat diet', '50-minute fixed pace treadmill running protocol']","['multiple serum inflammatory markers', 'Seven markers (BAFF/TNFSF-13, sCD30/TNFRSF8, sCD163, Chitinase3-like1, gp130SIL-6Rβ, sTNFR-1, and sTNFR-2', 'Fasting serum samples', 'inflammatory marker responses', ""Waldman, HS, Heatherly, AJ, Killen, LG, Hollingsworth, A, Koh, Y, and O'Neal, EK""]","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0521974', 'cui_str': 'High fat diet'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1682317', 'cui_str': 'TNFSF13B protein, human'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0071767', 'cui_str': 'Potassium Hydroxide'}]",8.0,0.012403,"Seven markers (BAFF/TNFSF-13, sCD30/TNFRSF8, sCD163, Chitinase3-like1, gp130SIL-6Rβ, sTNFR-1, and sTNFR-2) reached statistical significance (p < 0.05) favoring LCHF before exercise, and sCD30/TNFRSF8 favored (p < 0.05) LCHF before (HMD = 459 ± 111; LCHF = 296 ± 100) and after (HMD = 385 ± 104; LCHF = 285 ± 104 pg·ml) exercise.","[{'ForeName': 'Hunter S', 'Initials': 'HS', 'LastName': 'Waldman', 'Affiliation': 'Department of Kinesiology, Human Performance Lab, University of North Alabama, Florence, Alabama.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Heatherly', 'Affiliation': 'Department of Health and Human Performance, Middle Tennessee State University, Murfreesboro, Tennessee.'}, {'ForeName': 'Lauren G', 'Initials': 'LG', 'LastName': 'Killen', 'Affiliation': 'Department of Kinesiology, Human Performance Lab, University of North Alabama, Florence, Alabama.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Hollingsworth', 'Affiliation': 'University of Alabama-Huntsville, Huntsville, Alabama.'}, {'ForeName': 'Yunsuk', 'Initials': 'Y', 'LastName': 'Koh', 'Affiliation': 'Department of Health, Human Performance and Recreation, Baylor University, Waco, Texas.'}, {'ForeName': 'Eric K', 'Initials': 'EK', 'LastName': 'OʼNeal', 'Affiliation': 'Department of Kinesiology, Human Performance Lab, University of North Alabama, Florence, Alabama.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003761']
2983,32826836,Impact of Infant Positioning on Cardiopulmonary Resuscitation Performance During Simulated Pediatric Cardiac Arrest: A Randomized Crossover Study.,"OBJECTIVES


The primary objective was to determine the impact of infant positioning on cardiopulmonary resuscitation performance during simulated pediatric cardiac arrest.
DESIGN


A single-center, prospective, randomized, unblinded manikin study.
SETTING


Medical university-affiliated simulation facility.
SUBJECTS


Fifty-two first-line professional rescuers (n = 52).
INTERVENTIONS


Performance of cardiopulmonary resuscitation was determined using an infant manikin model in three different positions (on a table [T], on the provider's forearm with the manikin's head close to the provider's elbow [P], and on the provider's forearm with the manikin's head close to the provider's palm [D]). For the measurement of important cardiopulmonary resuscitation performance variables, a commercially available infant simulator was modified. In a randomized sequence, healthcare professionals performed single-rescuer cardiopulmonary resuscitation for 3 minutes in each position. Performances of chest compression (primary outcome), ventilation, and hands-off time were analyzed using a multilevel regression model.
MEASUREMENTS AND MAIN RESULTS


Mean (± SD) compression depth significantly differed between table and the other two manikin positions (31 ± 2 [T], 29 ± 3 [P], and 29 ± 3 mm [D]; overall p < 0.001; repeated measures design adjusted difference: T vs P, -2 mm [95% CI, -2 to -1 mm]; T vs D, -1 mm [95% CI, -2 to -1 mm]). Secondary outcome variables showed no significant differences.
CONCLUSIONS


Compressions were significantly deeper in the table group compared to positions on the forearm during cardiopulmonary resuscitation, yet the differences were small and perhaps not clinically important.",2020,"Secondary outcome variables showed no significant differences.
","['Medical university-affiliated simulation facility', 'Fifty-two first-line professional rescuers (n = 52']",[],"['Cardiopulmonary Resuscitation Performance', 'Mean (± SD) compression depth', 'Performances of chest compression (primary outcome), ventilation, and hands-off time', 'cardiopulmonary resuscitation performance']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]",[],"[{'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.058054,"Secondary outcome variables showed no significant differences.
","[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Mühlbacher', 'Affiliation': 'Department of Surgery, Division of General Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Pröbstl', 'Affiliation': 'Medical Simulation and Emergency Management Research Group, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Granegger', 'Affiliation': 'Pediatric Heart Center, Division of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Schiefer', 'Affiliation': 'Medical Simulation and Emergency Management Research Group, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Duma', 'Affiliation': 'Medical Simulation and Emergency Management Research Group, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hüpfl', 'Affiliation': 'Medical Simulation and Emergency Management Research Group, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Herkner', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Röhrich', 'Affiliation': 'Medical Simulation and Emergency Management Research Group, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Schebesta', 'Affiliation': 'Medical Simulation and Emergency Management Research Group, Department of Anaesthesia, Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002521']
2984,32827042,Response of mitochondrial respiration in adipose tissue and muscle to 8 weeks of endurance exercise in obese subjects.,"CONTEXT


Exercise training improves glycemic control and increases mitochondrial content and respiration capacity in skeletal muscle. Rodent studies suggest that training increases mitochondrial respiration in adipose tissue.
OBJECTIVE


To assess the effects of endurance training on respiratory capacities of human skeletal muscle and abdominal subcutaneous adipose tissue and to study the correlation with improvement in insulin sensitivity.
DESIGN


Using high resolution respirometry, we analyzed biopsies from 25 sedentary (VO2 peak 25.1 ± 4.0 VO2 ml/(kg*min)) subjects (16 females, 9 males; 29.8 ± 8.4 yrs) with obesity (BMI 31.5 ± 4.3 kg/m 2 ), who did not have diabetes. They performed a supervised endurance training over 8 weeks (3 x 1 hour/week at 80% VO 2 peak).
RESULTS


Based on change in insulin sensitivity after intervention, subjects were grouped in responders (>15% increase in ISIMatsuda) and low responders. The response in ISIMatsuda was correlated to a reduction of subcutaneous and visceral adipose tissue volume. Both groups exhibited similar increases in fitness, respiratory capacity, and in abundance of mitochondrial enzymes in skeletal muscle fibers. Respiratory capacities in subcutaneous adipose tissue were not altered by the intervention. Compared to muscle fibers, adipose tissue respiration showed a preference for β-oxidation and complex II substrates. Respiratory capacities were higher in adipose tissue from females.
CONCLUSION


Our data show that the improvement of peripheral insulin sensitivity after endurance training is not directly related to an increase in mitochondrial respiratory capacities in skeletal muscle and occurs without an increase in the respiratory capacity of subcutaneous adipose tissue.",2020,Our data show that the improvement of peripheral insulin sensitivity after endurance training is not directly related to an increase in mitochondrial respiratory capacities in skeletal muscle and occurs without an increase in the respiratory capacity of subcutaneous adipose tissue.,"['obese subjects', '25 sedentary (VO2 peak 25.1 ± 4.0 VO2 ml/(kg*min)) subjects (16 females, 9 males; 29.8 ± 8.4 yrs) with obesity (BMI 31.5 ± 4.3\xa0kg/m 2 ), who did not have diabetes']","['endurance exercise', 'endurance training', 'Exercise training', 'supervised endurance training']","['peripheral insulin sensitivity', 'Respiratory capacities', 'mitochondrial respiration', 'insulin sensitivity', 'fitness, respiratory capacity, and in abundance of mitochondrial enzymes in skeletal muscle fibers', 'subcutaneous and visceral adipose tissue volume']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0667627', 'cui_str': 'bis(kojato)oxovanadium(IV)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C1704336', 'cui_str': 'Skeletal muscle fiber'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",,0.0367935,Our data show that the improvement of peripheral insulin sensitivity after endurance training is not directly related to an increase in mitochondrial respiratory capacities in skeletal muscle and occurs without an increase in the respiratory capacity of subcutaneous adipose tissue.,"[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Hoffmann', 'Affiliation': 'Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schneeweiss', 'Affiliation': 'Department of Sports Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Elko', 'Initials': 'E', 'LastName': 'Randrianarisoa', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Günter', 'Initials': 'G', 'LastName': 'Schnauder', 'Affiliation': 'Department of Internal Medicine IV, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kappler', 'Affiliation': 'Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Machann', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Schick', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fritsche', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Heni', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Birkenfeld', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Niess', 'Affiliation': 'Department of Sports Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Häring', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Cora', 'Initials': 'C', 'LastName': 'Weigert', 'Affiliation': 'Institute for Clinical Chemistry and Pathobiochemistry, Department for Diagnostic Laboratory Medicine, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Moller', 'Affiliation': 'Institute for Diabetes Research and Metabolic Diseases of the Helmholtz Zentrum München at the University of Tübingen, Tübingen, Germany.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa571']
2985,32827053,Dissection with LigaSure Impact™ versus conventional resection in pylorus-preserving partial pancreatoduodenectomy (DISSECT): a single-institution randomized controlled trial.,"PURPOSE


In partial pancreatoduodenectomy, appropriate effective hemostasis during dissection is of major importance for procedural flow, operation time, and postoperative outcome. As ligation, clipping, or suturing of blood vessels is time-consuming and numerous instrument changes are required, the primary aim of this randomized controlled trial was to assess whether LigaSure Impact™ exhibits benefits over named conventional dissection techniques in patients undergoing pylorus-preserving partial pancreatoduodenectomy.
METHODS


This single-institution, randomized, superiority trial was performed between September 27, 2009, and February 24, 2012. Patients undergoing pylorus-preserving partial pancreatoduodenectomy were allocated to the study arms in a 1:1 ratio based on an unstratified block randomization with random block sizes to receive either dissection with LigaSure Impact™ or conventional dissection. The primary endpoint was operation time. Secondary endpoints included peri- and postoperative morbidity and mortality, intraoperative blood loss, and length of hospital stay. To observe a time reduction of 40 min, 51 patients per arm were required. The primary analysis was the intention to treat.
RESULTS


The mean operation time did not differ between the Ligasure Impact™ (308 min; SD: 56 min; range: 155-455 min) and the conventional dissection (318 min; SD: 90 min, range: 175-550 min) (p = 0.531). Moreover, LigaSure Impact™ dissection did not show significant advantages over conventional dissection in terms of peri- and postoperative morbidity and mortality, intraoperative blood loss, or length of hospital stay.
CONCLUSIONS


The application of LigaSure Impact™ dissection in pylorus-preserving partial pancreatoduodenectomy does not increase effectiveness and safety of dissection.
TRIAL REGISTRATION


DRKS00000166.",2020,"Moreover, LigaSure Impact™ dissection did not show significant advantages over conventional dissection in terms of peri- and postoperative morbidity and mortality, intraoperative blood loss, or length of hospital stay.
","['Patients undergoing pylorus-preserving partial pancreatoduodenectomy', 'September 27, 2009, and February 24, 2012', 'pylorus-preserving partial pancreatoduodenectomy (DISSECT', 'patients undergoing pylorus-preserving partial pancreatoduodenectomy']","['Dissection with LigaSure Impact™ versus conventional resection', 'dissection with LigaSure Impact™ or conventional dissection']","['peri- and postoperative morbidity and mortality, intraoperative blood loss, and length of hospital stay', 'peri- and postoperative morbidity and mortality, intraoperative blood loss, or length of hospital stay', 'intention to treat', 'mean operation time', 'operation time']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0085162', 'cui_str': 'Pancreaticoduodenectomy'}, {'cui': 'C0205239', 'cui_str': 'Dissecting'}]","[{'cui': 'C0012737', 'cui_str': 'Dissection - action'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.269743,"Moreover, LigaSure Impact™ dissection did not show significant advantages over conventional dissection in terms of peri- and postoperative morbidity and mortality, intraoperative blood loss, or length of hospital stay.
","[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Gehrig', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany. tobias.gehrig@spital-linth.ch.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Josef', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Billeter', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Warschkow', 'Affiliation': 'Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen, 9007, St. Gallen, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Knebel', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Gutt', 'Affiliation': 'Department of General, Vascular, Thoracic and Visceral Surgery, Klinikum Memmingen, 87700, Memmingen, Germany.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Diener', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Tarantino', 'Affiliation': 'Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany.'}]",Langenbeck's archives of surgery,['10.1007/s00423-020-01968-y']
2986,32827307,Prophylactic nimodipine treatment improves hearing outcome after vestibular schwannoma surgery in men: a subgroup analysis of a randomized multicenter phase III trial.,"A 2016 published randomized multicenter phase III trial of prophylactic nimodipine treatment in vestibular schwannoma surgery showed only a tendency for higher hearing preservation rates in the treatment group. Gender was not included in statistical analysis at that time. A retrospective analysis of the trial considering gender, preoperative hearing, and nimodipine treatment was performed. The treatment group received parenteral nimodipine from the day before surgery until the seventh postoperative day. The control group was not treated prophylactically. Cochlear nerve function was determined by pure-tone audiometry with speech discrimination preoperatively, during in-patient care, and 1 year after surgery and classified according to the Gardner-Robertson grading scale (GR). Logistic regression analysis showed a statistically significant effect for higher hearing preservation rates (pre- and postoperative GR 1-4) in 40 men comparing the treatment (n = 21) and the control (n = 19) groups (p = 0.028), but not in 54 women comparing 27 women in both groups (p = 0.077). The results were also statistically significant for preservation of postoperative hearing with pre- and postoperative GR 1-3 (p = 0.024). There were no differences in tumor sizes between the treatment and the control groups in men, whereas statistically significant larger tumors were observed in the female treatment group compared with the female control group. Prophylactic nimodipine is safe, and an effect for hearing preservation in 40 men with preoperative hearing ability of GR 1-4 was shown in this retrospective investigation. The imbalance in tumor size with larger tumors in females of the treatment group may falsely suggest a gender-related effect. Further investigations are recommended to clarify whether gender has impact on nimodipine's efficacy.",2020,"Logistic regression analysis showed a statistically significant effect for higher hearing preservation rates (pre- and postoperative GR 1-4) in 40 men comparing the treatment (n = 21) and the control (n = 19) groups (p = 0.028), but not in 54 women comparing 27 women in both groups (p = 0.077).","['40 men with preoperative hearing ability of GR 1-4', 'after vestibular schwannoma surgery in men']","['nimodipine', 'prophylactic nimodipine', 'parenteral nimodipine', 'Prophylactic nimodipine']","['Cochlear nerve function', 'hearing preservation rates', 'tumor sizes', 'hearing outcome', 'preservation of postoperative hearing']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027859', 'cui_str': 'Acoustic neuroma'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0028094', 'cui_str': 'Nimodipine'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}]","[{'cui': 'C0234310', 'cui_str': 'Cochlear nerve function'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",40.0,0.0598469,"Logistic regression analysis showed a statistically significant effect for higher hearing preservation rates (pre- and postoperative GR 1-4) in 40 men comparing the treatment (n = 21) and the control (n = 19) groups (p = 0.028), but not in 54 women comparing 27 women in both groups (p = 0.077).","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Scheller', 'Affiliation': 'Department of Neurosurgery, Martin Luther University Halle-Wittenberg, Ernst-Grube-Str. 40, 06097, Halle (Salle), Germany. christian.scheller@uk-halle.de.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Rampp', 'Affiliation': 'Department of Neurosurgery, Martin Luther University Halle-Wittenberg, Ernst-Grube-Str. 40, 06097, Halle (Salle), Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Leisz', 'Affiliation': 'Department of Neurosurgery, Martin Luther University Halle-Wittenberg, Ernst-Grube-Str. 40, 06097, Halle (Salle), Germany.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Tatagiba', 'Affiliation': 'Department of Neurosurgery, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Gharabaghi', 'Affiliation': 'Department of Neurosurgery, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Kristofer F', 'Initials': 'KF', 'LastName': 'Ramina', 'Affiliation': 'Department of Neurosurgery, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Ganslandt', 'Affiliation': 'Department of Neurosurgery, Stuttgart Hospital, Stuttgart, Germany.'}, {'ForeName': 'Cordula', 'Initials': 'C', 'LastName': 'Matthies', 'Affiliation': 'Department of Neurosurgery, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Westermaier', 'Affiliation': 'Department of Neurosurgery, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Antoniadis', 'Affiliation': 'Department of Neurosurgery, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Pedro', 'Affiliation': 'Department of Neurosurgery, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Veit', 'Initials': 'V', 'LastName': 'Rohde', 'Affiliation': 'Department of Neurosurgery, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Kajetan', 'Initials': 'K', 'LastName': 'von Eckardstein', 'Affiliation': 'Department of Neurosurgery, Westpfalz-Klinikum Kaiserslautern, Kaiserslautern, Germany.'}, {'ForeName': 'Konstanze', 'Initials': 'K', 'LastName': 'Scheller', 'Affiliation': 'Department of Oral and Maxillofacial and Facial Plastic Surgery, Martin Luther University Halle-Wittenberg, Halle, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Strauss', 'Affiliation': 'Department of Neurosurgery, Martin Luther University Halle-Wittenberg, Ernst-Grube-Str. 40, 06097, Halle (Salle), Germany.'}]",Neurosurgical review,['10.1007/s10143-020-01368-2']
2987,32827344,Automatic Oxygen Flow Titration in Spontaneously Breathing Children: An Open Label Randomised Controlled Pilot Study.,"INTRODUCTION


When children require supplemental oxygen due to acute hypoxemic respiratory distress, manual control of the oxygen flow is often difficult and time consuming, and carries the risk of unrecognized hypoxia and hyperoxia. To date, no automatic oxygen titration system has been developed and evaluated in spontaneously breathing children.
METHODS


Children between 1 month and 15 years of age receiveing supplemental oxygen due to acute hypoxemic respiratory distress were recruited within 24 hours following the onset of the O2 administration in a French University Department of Paediatrics. Patients were randomised to receive either automated oxygen administration using the FreeO2 device, or conventional manual oxygen administration over a maximum period of 6 hours. Stratification was performed to classify the patients into two age groups: [1 month-2 years of age[and [2-15 years of age[. The primary outcome was % time spent within SpO 2  target range [92-98%].
RESULTS


60 patients (30 infants, 30 children) were randomised and 55 could be analysed for primary outcome (28 automated, 27 manual). The automated O 2  delivery using the FreeO2 device significantly increased the time spent within the predefined SpO 2  range (94.6±6% versus 76.3±22%, difference (95% CI) 18.4 (10.1; 26.7)) with less time spent with hypoxemia (1±1.1% versus 15.1±21.8%, difference (95% CI) -14.4 (-22.2; -6.7)). This difference was greater among [2-15 years of age[children, compared to [1 month-2 years of age[infants.
CONCLUSIONS


The present randomised controlled pilot study indicates that the tested automated closed-loop O 2  titration technology was safe and yielded improved oxygen parameters among spontaneously breathing children. Based on our pilot data, a full randomised controlled trial will be required to verify the potential clinical benefits. This article is protected by copyright. All rights reserved.",2020,"This difference was greater among [2-15 years of age[children, compared to [1 month-2 years of age[infants.
","['60 patients (30 infants, 30 children', 'patients into two age groups: [1 month-2 years of age[and [2-15 years of age', 'spontaneously breathing children', 'Spontaneously Breathing Children', 'Children between 1 month and 15 years of age receiveing supplemental oxygen due to acute hypoxemic respiratory distress were recruited within 24 hours following the onset of the O2 administration in a French University Department of Paediatrics']","['Automatic Oxygen Flow Titration', 'automated oxygen administration using the FreeO2 device, or conventional manual oxygen administration']","['time spent', 'time spent with hypoxemia', 'time spent within SpO 2  target range', 'oxygen parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}]","[{'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",30.0,0.321173,"This difference was greater among [2-15 years of age[children, compared to [1 month-2 years of age[infants.
","[{'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Roué', 'Affiliation': 'Department of Pediatrics, Brest University Hospital, Brest, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Delpeut', 'Affiliation': 'Department of Pediatrics, Brest University Hospital, Brest, France.'}, {'ForeName': 'Alix', 'Initials': 'A', 'LastName': ""d'Hennezel"", 'Affiliation': 'Department of Pediatrics, Brest University Hospital, Brest, France.'}, {'ForeName': 'Tess', 'Initials': 'T', 'LastName': 'Tierrie', 'Affiliation': 'Department of Pediatrics, Brest University Hospital, Brest, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Barzic', 'Affiliation': 'Department of Pediatrics, Brest University Hospital, Brest, France.'}, {'ForeName': 'Erwan', 'Initials': 'E', 'LastName': ""L'Her"", 'Affiliation': 'Medical Intensive Care, LATIM INSERM UMR 1101, Brest University Hospital, Brest, France.'}, {'ForeName': 'Pierrick', 'Initials': 'P', 'LastName': 'Cros', 'Affiliation': 'Department of Pediatrics, Brest University Hospital, Brest, France.'}]",Pediatric pulmonology,['10.1002/ppul.25035']
2988,32827348,"Double-Blind, Placebo-Controlled Study of Lurasidone Monotherapy for the Treatment of Bipolar I Depression.","AIM


Previous studies conducted primarily in the US and Europe have demonstrated the efficacy and safety of lurasidone 20-120 mg/day for the treatment of bipolar I depression. The aim of the current study was to evaluate the efficacy and safety of lurasidone monotherapy for the treatment of bipolar I depression among patients from diverse ethnic backgrounds including those from Japan.
METHODS


Patients were randomly assigned to double-blind treatment with lurasidone, 20-60 mg/day (N = 182) or 80-120 mg/day (N = 169) or placebo (N = 171) for 6 weeks. The primary endpoint was change from baseline to week 6 on the Montgomery Åsberg Depression Rating Scale (MADRS).
RESULTS


Lurasidone treatment significantly reduced mean MADRS total scores from baseline to week 6 for the 20-60 mg/day group (-13.6; adjusted p = 0.007; effect size = 0.33), but not for the 80-120 mg/day group (-12.6; adjusted p = 0.057; effect size = 0.22) compared with placebo (-10.6). Treatment with lurasidone 20-60 mg/day also improved MADRS response rates, functional impairment, and anxiety symptoms. The most common adverse events associated with lurasidone were akathisia and nausea. Lurasidone treatments were associated with minimal changes in body weight, lipids, and measures of glycemic control.
CONCLUSION


Monotherapy with daily doses of lurasidone 20-60 mg, but not 80-120 mg, significantly reduced depressive symptoms and improved functioning and was well tolerated with few changes in weight or metabolic parameters in patients with bipolar I depression. Results were overall consistent with previous studies, suggesting that lurasidone 20-60 mg/day is effective and safe in diverse ethnic populations including Japanese. This article is protected by copyright. All rights reserved.",2020,"RESULTS


Lurasidone treatment significantly reduced mean MADRS total scores from baseline to week 6 for the 20-60 mg/day group (-13.6; adjusted p = 0.007; effect size = 0.33), but not for the 80-120 mg/day group (-12.6; adjusted p = 0.057; effect size = 0.22) compared with placebo (-10.6).","['patients with bipolar I depression', 'bipolar I depression among patients from diverse ethnic backgrounds including those from Japan', 'Patients']","['lurasidone', 'Placebo', 'Monotherapy', 'lurasidone monotherapy', 'Lurasidone Monotherapy', 'placebo']","['Montgomery Åsberg Depression Rating Scale (MADRS', 'depressive symptoms', 'weight or metabolic parameters', 'efficacy and safety', 'akathisia and nausea', 'mean MADRS total scores', 'MADRS response rates, functional impairment, and anxiety symptoms', 'body weight, lipids, and measures of glycemic control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.15438,"RESULTS


Lurasidone treatment significantly reduced mean MADRS total scores from baseline to week 6 for the 20-60 mg/day group (-13.6; adjusted p = 0.007; effect size = 0.33), but not for the 80-120 mg/day group (-12.6; adjusted p = 0.057; effect size = 0.22) compared with placebo (-10.6).","[{'ForeName': 'Tadafumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Laboratory for Molecular Dynamics of Mental Disorders, RIKEN Center for Brain Science, Wako, Saitama, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ishigooka', 'Affiliation': 'Institute of CNS Pharmacology, Tokyo, Japan.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Miyajima', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Watabe', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Fujimori', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Masuda', 'Affiliation': 'Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Japan Depression Center, Tokyo, Japan.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Vieta', 'Affiliation': 'Bipolar and Depressive Disorders Unit, Hospital Clinic, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain.'}]",Psychiatry and clinical neurosciences,['10.1111/pcn.13137']
2989,32797683,How does yoga reduce stress? A clinical trial testing psychological mechanisms.,"Yoga interventions can reduce stress, but the mechanisms underlying that stress reduction remain largely unidentified. Understanding how yoga works is essential to optimizing interventions. The present study tested five potential psychosocial mechanisms (increased mindfulness, interoceptive awareness, spiritual well-being, self-compassion and self-control) that have been proposed to explain yoga's impact on stress. Forty-two participants (62% female; 64% White) in a yoga program for stress reduction completed surveys at baseline (T1), mid-intervention (T2) and post-intervention (12 weeks; T3). We measured two aspects of stress, perceived stress and stress reactivity. Changes were assessed with paired t-tests; associations between changes in mechanisms were tested in residual change models. Only stress reactivity decreased, on average, from T1 to T3. Except for self-compassion, all psychosocial mechanisms increased from T1 to T3, with minimal changes from T2 to T3. Except for self-control, increases in each mechanism were strongly associated with decreases in both measures of stress between T1 and T2 and decreases in perceived stress from T1 to T3 (all p's < 0.05). Increased psychosocial resources are associated with stress reduction. Yoga interventions targeting these resources may show stronger stress reduction effects. Future research should test these linkages more rigorously using active comparison groups and larger samples.",2020,"Except for self-compassion, all psychosocial mechanisms increased from T1 to T3, with minimal changes from T2 to T3.",[],[],['stress reactivity'],[],[],"[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",42.0,0.0112585,"Except for self-compassion, all psychosocial mechanisms increased from T1 to T3, with minimal changes from T2 to T3.","[{'ForeName': 'Crystal L', 'Initials': 'CL', 'LastName': 'Park', 'Affiliation': 'Department of Psychological Sciences, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Finkelstein-Fox', 'Affiliation': 'Department of Psychological Sciences, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Shane J', 'Initials': 'SJ', 'LastName': 'Sacco', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Tosca D', 'Initials': 'TD', 'LastName': 'Braun', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, Rhode Island, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lazar', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA.'}]",Stress and health : journal of the International Society for the Investigation of Stress,['10.1002/smi.2977']
2990,32822216,Hormetic modulation of angiogenic factors by exercise-induced mechanical and metabolic stress in human skeletal muscle.,"This study used an integrative experimental model in humans to investigate whether muscle angiogenic factors are differentially modulated by exercise stimuli eliciting different degrees of mechanical and metabolic stress. In a randomized crossover design, twelve men performed two low‑volume high-intensity exercise regimens, including short sprint intervals (SSI) or long sprint intervals (LSI) inducing pronounced mechanical/metabolic stress, and a high‑volume moderate‑intensity continuous exercise protocol (MIC) inducing mild but prolonged mechanical/metabolic stress. Gene and protein expression of angioregulatory factors was determined in vastus lateralis muscle samples obtained before and after exercise. Exercise upregulated muscle VEGF mRNA to a greater extent in LSI and MIC compared to SSI. Analysis of angioregulatory factors sensitive to shear stress revealed more marked exercise-induced VEGF‑R2 mRNA responses in MIC than SSI, as well as greater PECAM‑1 and eNOS mRNA responses in LSI than SSI. No apparent exercise‑induced phosphorylation of shear stress‑sensory proteins VEGF‑R2 Tyr1175 , PECAM‑1 Tyr713  and eNOS Ser1177  was observed despite robust elevations in femoral artery shear stress. Exercise evoked greater mRNA responses of the mechanical stretch sensor MMP9 in SSI than MIC. Exercise‑induced mRNA responses of the metabolic stress sensor HIF‑1α were more profound in LSI than SSI. These results suggest that low-volume high-intensity exercise transcriptionally activates angiogenic factors in a mechanical/metabolic stress‑dependent manner. Furthermore, the angiogenic potency of low-volume high-intensity exercise appears similar to that of high‑volume moderate‑intensity exercise, but only on condition of eliciting severe mechanical/metabolic stress. We conclude that the angiogenic stimulus produced by exercise depends on both magnitude and protraction of myocellular homeostatic perturbations.",2020,Exercise‑induced mRNA responses of the metabolic stress sensor HIF‑1α were more profound in LSI than SSI.,"['twelve men performed two', 'human skeletal muscle']","['low‑volume high-intensity exercise regimens, including short sprint intervals (SSI) or long sprint intervals (LSI) inducing pronounced mechanical/metabolic stress, and a high‑volume moderate‑intensity continuous exercise protocol (MIC']",['Gene and protein expression of angioregulatory factors'],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C2350024', 'cui_str': 'Metabolic Stress'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",12.0,0.0206168,Exercise‑induced mRNA responses of the metabolic stress sensor HIF‑1α were more profound in LSI than SSI.,"[{'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Fiorenza', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Gliemann', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Brandt', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Bangsbo', 'Affiliation': 'Department of Nutrition, Exercise and Sports, University of Copenhagen, Denmark.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00432.2020']
2991,32822362,"Evaluation of seasonal malaria chemoprevention in two areas of intense seasonal malaria transmission: Secondary analysis of a household-randomised, placebo-controlled trial in Houndé District, Burkina Faso and Bougouni District, Mali.","BACKGROUND


Seasonal malaria chemoprevention (SMC) is now widely deployed in the Sahel, including several countries that are major contributors to the global burden of malaria. Consequently, it is important to understand whether SMC continues to provide a high level of protection and how SMC might be improved. SMC was evaluated using data from a large, household-randomised trial in Houndé, Burkina Faso and Bougouni, Mali.
METHODS AND FINDINGS


The parent trial evaluated monthly SMC plus either azithromycin (AZ) or placebo, administered as directly observed therapy 4 times per year between August and November (2014-2016). In July 2014, 19,578 children aged 3-59 months were randomised by household to study group. Children who remained within the age range 3-59 months in August each year, plus children born into study households or who moved into the study area, received study drugs in 2015 and 2016. These analyses focus on the approximately 10,000 children (5,000 per country) under observation each year in the SMC plus placebo group. Despite high coverage and high adherence to SMC, the incidence of hospitalisations or deaths due to malaria and uncomplicated clinical malaria remained high in the study areas (overall incidence rates 12.5 [95% confidence interval (CI): 11.2, 14.1] and 871.1 [95% CI: 852.3, 890.6] cases per 1,000 person-years, respectively) and peaked in July each year, before SMC delivery began in August. The incidence rate ratio comparing SMC within the past 28 days with SMC more than 35 days ago-adjusted for age, country, and household clustering-was 0.13 (95% CI: 0.08, 0.20), P < 0.001 for malaria hospitalisations and deaths from malaria and 0.21 (95% CI 0.20, 0.23), P < 0.001 for uncomplicated malaria, indicating protective efficacy of 87.4% (95% CI: 79.6%, 92.2%) and 78.3% (95% CI: 76.8%, 79.6%), respectively. The prevalence of malaria parasitaemia at weekly surveys during the rainy season and at the end of the transmission season was several times higher in children who missed the SMC course preceding the survey contact, and the smallest prevalence ratio observed was 2.98 (95% CI: 1.95, 4.54), P < 0.001. The frequency of molecular markers of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) resistance did not increase markedly over the study period either amongst study children or amongst school-age children resident in the study areas. After 3 years of SMC deployment, the day 28 PCR-unadjusted adequate clinical and parasitological response rate of the SP + AQ regimen in children with asymptomatic malaria was 98.3% (95% CI: 88.6%, 99.8%) in Burkina Faso and 96.1% (95% CI: 91.5%, 98.2%) in Mali. Key limitations of this study are the potential overdiagnosis of uncomplicated malaria by rapid diagnostic tests and the potential for residual confounding from factors related to adherence to the monthly SMC schedule.
CONCLUSION


Despite strong evidence that SMC is providing a high level of protection, the burden of malaria remains substantial in the 2 study areas. These results emphasise the need for continuing support of SMC programmes. A fifth monthly SMC course is needed to adequately cover the whole transmission season in the study areas and in settings with similar epidemiology.
TRIAL REGISTRATION


The AZ-SMC trial in which these data were collected was registered at clinicaltrials.gov: NCT02211729.",2020,"Despite high coverage and high adherence to SMC, the incidence of hospitalisations or deaths due to malaria and uncomplicated clinical malaria remained high in the study areas (overall incidence rates 12.5 [95% confidence interval (CI): 11.2, 14.1] and 871.1 [95% CI: 852.3, 890.6] cases per 1,000 person-years, respectively) and peaked in July each year, before SMC delivery began in August.","['In July 2014, 19,578 children aged 3-59 months', 'Houndé District, Burkina Faso and Bougouni District, Mali', 'approximately 10,000 children (5,000 per country) under observation each year in the SMC plus placebo group', 'Children who remained within the age range 3-59 months in August each year, plus children born into study households or who moved into the study area, received study drugs in 2015 and 2016', 'study children or amongst school-age children resident in the study areas']","['seasonal malaria chemoprevention', 'azithromycin (AZ) or placebo', 'sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) resistance', 'SP + AQ', 'placebo']","['prevalence of malaria parasitaemia', 'parasitological response rate', 'incidence rate ratio comparing SMC', 'smallest prevalence ratio', 'protective efficacy']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0024581', 'cui_str': 'Mali'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0578671', 'cui_str': 'Does move'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0700599', 'cui_str': 'Pyrimethamine- and sulfadoxine-containing product'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0205468', 'cui_str': 'Parasitologic'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0282515', 'cui_str': 'Prophylactic chemotherapy'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",19578.0,0.276926,"Despite high coverage and high adherence to SMC, the incidence of hospitalisations or deaths due to malaria and uncomplicated clinical malaria remained high in the study areas (overall incidence rates 12.5 [95% confidence interval (CI): 11.2, 14.1] and 871.1 [95% CI: 852.3, 890.6] cases per 1,000 person-years, respectively) and peaked in July each year, before SMC delivery began in August.","[{'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Cairns', 'Affiliation': 'Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Sagara', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Issaka', 'Initials': 'I', 'LastName': 'Zongo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Kuepfer', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Ismaila', 'Initials': 'I', 'LastName': 'Thera', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Nikiema', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Modibo', 'Initials': 'M', 'LastName': 'Diarra', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Serge R', 'Initials': 'SR', 'LastName': 'Yerbanga', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Barry', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Amadou', 'Initials': 'A', 'LastName': 'Tapily', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Samba', 'Initials': 'S', 'LastName': 'Coumare', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Milligan', 'Affiliation': 'Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Jean Bosco', 'Initials': 'JB', 'LastName': 'Ouédraogo', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Bobo Dioulasso, Burkina Faso.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chandramohan', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Greenwood', 'Affiliation': 'Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Abdoulaye', 'Initials': 'A', 'LastName': 'Djimde', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}, {'ForeName': 'Alassane', 'Initials': 'A', 'LastName': 'Dicko', 'Affiliation': 'Malaria Research and Training Centre, Bamako, Mali.'}]",PLoS medicine,['10.1371/journal.pmed.1003214']
2992,32822417,Correction: Variability in engagement and progress in efficacious integrated collaborative care for primary care patients with obesity and depression: Within-treatment analysis in the RAINBOW trial.,[This corrects the article DOI: 10.1371/journal.pone.0231743.].,2020,[This corrects the article DOI: 10.1371/journal.pone.0231743.].,['primary care patients with obesity and depression'],[],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",[],[],,0.0271133,[This corrects the article DOI: 10.1371/journal.pone.0231743.].,"[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': ''}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': ''}, {'ForeName': 'Marzieh', 'Initials': 'M', 'LastName': 'Majd', 'Affiliation': ''}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Lavori', 'Affiliation': ''}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': ''}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': ''}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': ''}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': ''}, {'ForeName': 'Megan A', 'Initials': 'MA', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Ward', 'Affiliation': ''}, {'ForeName': 'Lenard I', 'Initials': 'LI', 'LastName': 'Lesser', 'Affiliation': ''}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Kristen M J', 'Initials': 'KMJ', 'LastName': 'Azar', 'Affiliation': ''}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0238276']
2993,32822510,Double-Blind Randomized Trial on the Efficacy of the Forced Prolonged Position for Treatment of Lateral Canal Benign Paroxysmal Positional Vertigo.,"OBJECTIVES/HYPOTHESIS


The need for class I and II studies on the efficacy of liberatory maneuvers in the treatment of lateral canal benign paroxysmal positional vertigo (LC-BPPV) motivated the present double-blind randomized trial on the short-term efficacy of the forced prolonged position (FPP).
STUDY DESIGN


Double-blind, randomized controlled trial.
METHODS


Two hundred twenty-one patients with unilateral LC-BPPV met the inclusion criteria for a multicentric study. Patients were randomly assigned to treatment by FPP (116 subjects) or sham treatment (105 subjects). Subjects were followed up at 24 hours with the supine roll test by blinded examiners.
RESULTS


Among the sample, 67.4% and 32.6% of the patients showed respectively geotropic and apogeotropic variant of LC-BPPV. At the 24-hour follow-up, the effectiveness of FFP compared to the sham maneuver was, respectively, 57.8% versus 12.4% (P < .0001) in the total sample, 76.9% versus 11.3% (P < .0001) in the geotropic variant group, and 60.5% versus 17.6% (P = .0003) in the apogeotropic variant group, including resolution or transformation to geotropic variant.
CONCLUSIONS


FPP proved highly effective compared to the sham maneuver. The present class 2 study of the efficacy of the FPP changes the level of recommendation of the method for treating LC-BPPV into a strong one.
LEVEL OF EVIDENCE


2 Laryngoscope, 2020.",2020,"At the 24-hour follow-up, the effectiveness of FFP compared to the sham maneuver was, respectively, 57.8% versus 12.4% (P < .0001) in the total sample, 76.9% versus 11.3% (P < .0001) in the geotropic variant group, and 60.5% versus 17.6% (P = .0003) in the apogeotropic variant group, including resolution or transformation to geotropic variant.
","['Lateral Canal Benign Paroxysmal Positional Vertigo', 'lateral canal benign paroxysmal positional vertigo (LC-BPPV', 'Two hundred twenty-one patients with unilateral LC-BPPV met the inclusion criteria for a multicentric study']","['Forced Prolonged Position', 'forced prolonged position (FPP', 'FPP']","['effectiveness of FFP', 'geotropic and apogeotropic variant of LC-BPPV', 'resolution or transformation to geotropic variant']","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0155502', 'cui_str': 'Benign paroxysmal positional vertigo'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439743', 'cui_str': 'Multicentric'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0733755', 'cui_str': 'Position'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0016709', 'cui_str': 'Fresh frozen plasma'}, {'cui': 'C0205419', 'cui_str': 'Variant'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0155502', 'cui_str': 'Benign paroxysmal positional vertigo'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}]",221.0,0.352727,"At the 24-hour follow-up, the effectiveness of FFP compared to the sham maneuver was, respectively, 57.8% versus 12.4% (P < .0001) in the total sample, 76.9% versus 11.3% (P < .0001) in the geotropic variant group, and 60.5% versus 17.6% (P = .0003) in the apogeotropic variant group, including resolution or transformation to geotropic variant.
","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mandalà', 'Affiliation': 'Department of Otolaryngology, Azienda Ospedaliera Universitaria Senese, Siena, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Califano', 'Affiliation': 'Audiology and Phoniatrics Unit, Ospedale G. Rummo, Benevento, Italy.'}, {'ForeName': 'Augusto Pietro', 'Initials': 'AP', 'LastName': 'Casani', 'Affiliation': 'Department of Neuroscience, Otorhinolaryngology Unit, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Faralli', 'Affiliation': 'ENT Department, University of Perugia, Perugia, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Marcelli', 'Affiliation': 'San Giovanni Bosco Hospital, Naples, Italy.'}, {'ForeName': 'Giampiero', 'Initials': 'G', 'LastName': 'Neri', 'Affiliation': 'Department of Neuroscience, Imaging and Clinical Sciences, Otorhinolaryngology Unit, University of Chieti, Chieti, Italy.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Pecci', 'Affiliation': 'Department of Oto-Neuro-Ophthalmology, Audiology Unit, University of Florence, Florence, Italy.'}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Scasso', 'Affiliation': 'U.O. ORL, Ospedale P A Micone-ASL 3, Genova, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Scotto di Santillo', 'Affiliation': 'U.O. ORL, Ospedale P A Micone-ASL 3, Genova, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Vannucchi', 'Affiliation': 'Department of Oto-Neuro-Ophthalmology, Audiology Unit, University of Florence, Florence, Italy.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Giannoni', 'Affiliation': 'Department of Oto-Neuro-Ophthalmology, Audiology Unit, University of Florence, Florence, Italy.'}, {'ForeName': 'Soumit', 'Initials': 'S', 'LastName': 'Dasgupta', 'Affiliation': ""Department of Audiovestibular Medicine and Neurotology, Alder Hey Children's Hospital NHS Trust, Liverpool, United Kingdom.""}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Bindi', 'Affiliation': 'Department of Otolaryngology, Azienda Ospedaliera Universitaria Senese, Siena, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Salerni', 'Affiliation': 'Department of Otolaryngology, Azienda Ospedaliera Universitaria Senese, Siena, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Nuti', 'Affiliation': 'Department of Otolaryngology, Azienda Ospedaliera Universitaria Senese, Siena, Italy.'}]",The Laryngoscope,['10.1002/lary.28981']
2994,32822528,The Effect of Metabolic Syndrome Status on Lung Function and Patient-reported Outcomes in Patients with COPD Receiving Nebulized Glycopyrrolate.,"Background


Concurrent chronic obstructive pulmonary disease (COPD) and metabolic syndrome (MetS) represent an important clinical phenotype with overlapping symptomology. The effect of MetS in COPD patients was assessed following treatment with nebulized glycopyrrolate (GLY; administered via eFlow® Closed System Nebulizer).
Methods


Posthoc analyses were performed on pooled lung function, patient-reported outcome (PRO) and safety data by MetS status from patients treated with placebo, GLY 25 and 50 mcg twice daily in two 12-week studies (GOLDEN 3 and 4; N=1293). Patients with MetS were characterized as having ≥ 3 of hypertension, hyperlipidemia, diabetes, body mass index (BMI) > 30 kg/m 2  risk factors. The results are presented for the Food and Drug Administration-approved GLY 25 mcg dose.
Results


A total of25% of patients met MetS criteria.At baseline, the MetS subgroup had higher BMIs, more ex-smokers, greater incidences of cardiovascular risk factors, and MetS-specific risk factors were 2-14 times higher than non-MetS. At 12 weeks, GLY produced significant, clinically important improvements (MetS: 0.121 L; non-MetS: 0.083 L) in trough forced expiratory volume in 1 second. In the non-MetS group, significant improvements occurred in the St George's Respiratory Questionnaire (MetS: -2.28,  p =0.157; non-MetS: -3.71) and Evaluating Respiratory Symptoms in COPD tool (MetS: 0.42,  p =0.574; non-MetS: -1.61) total scores. Incidence of adverse events was similar with GLY versus placebo regardless of MetS status.
Conclusion


GLY was well-tolerated and significantly improved lung function regardless of MetS status, while significant PRO improvements occurred in non-MetS patients. These results highlight the importance of comorbidities on bronchodilator responses and patient symptoms in COPD patients.",2020,"At baseline, the MetS subgroup had higher BMIs, more ex-smokers, greater incidences of cardiovascular risk factors, and MetS-specific risk factors were 2-14 times higher than non-MetS. At 12 weeks, GLY produced significant, clinically important improvements (MetS: 0.121 L; non-MetS: 0.083 L) in trough forced expiratory volume in 1 second.","['Patients with COPD Receiving', 'COPD patients', 'Patients with MetS were characterized as having ≥ 3 of hypertension, hyperlipidemia, diabetes, body mass index (BMI) > 30 kg/m 2  risk factors']","['placebo, GLY', 'nebulized glycopyrrolate (GLY', 'Nebulized Glycopyrrolate', 'placebo']","['lung function regardless of MetS status', ""St George's Respiratory Questionnaire (MetS"", 'cardiovascular risk factors, and MetS-specific risk factors', 'PRO improvements', 'Incidence of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}]","[{'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0476815,"At baseline, the MetS subgroup had higher BMIs, more ex-smokers, greater incidences of cardiovascular risk factors, and MetS-specific risk factors were 2-14 times higher than non-MetS. At 12 weeks, GLY produced significant, clinically important improvements (MetS: 0.121 L; non-MetS: 0.083 L) in trough forced expiratory volume in 1 second.","[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Carlin', 'Affiliation': 'Sleep Medicine and Lung Health Consultants, LLC, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Michigan.'}, {'ForeName': 'Ayca', 'Initials': 'A', 'LastName': 'Ozol-Godfrey', 'Affiliation': 'Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Goodin', 'Affiliation': 'Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Sanjar', 'Affiliation': 'Sunovion Pharmaceuticals, Inc., Marlborough, Massachusetts.'}]","Chronic obstructive pulmonary diseases (Miami, Fla.)",['10.15326/jcopdf.7.4.2020.0145']
2995,32822600,"Efficacy and safety of once-daily nitisinone for patients with alkaptonuria (SONIA 2): an international, multicentre, open-label, randomised controlled trial.","BACKGROUND


Alkaptonuria is a rare, genetic, multisystem disease characterised by the accumulation of homogentisic acid (HGA). No HGA-lowering therapy has been approved to date. The aim of SONIA 2 was to investigate the efficacy and safety of once-daily nitisinone for reducing HGA excretion in patients with alkaptonuria and to evaluate whether nitisinone has a clinical benefit.
METHODS


SONIA 2 was a 4-year, open-label, evaluator-blind, randomised, no treatment controlled, parallel-group study done at three sites in the UK, France, and Slovakia. Patients aged 25 years or older with confirmed alkaptonuria and any clinical disease manifestations were randomly assigned (1:1) to receive either oral nitisinone 10 mg daily or no treatment. Patients could not be masked to treatment due to colour changes in the urine, but the study was evaluator-blinded as far as possible. The primary endpoint was daily urinary HGA excretion (u-HGA 24 ) after 12 months. Clinical evaluation Alkaptonuria Severity Score Index (cAKUSSI) score was assessed at 12, 24, 36, and 48 months. Efficacy variables were analysed in all randomly assigned patients with a valid u-HGA 24  measurement at baseline. Safety variables were analysed in all randomly assigned patients. The study was registered at ClinicalTrials.gov (NCT01916382).
FINDINGS


Between May 7, 2014, and Feb 16, 2015, 139 patients were screened, of whom 138 were included in the study, with 69 patients randomly assigned to each group. 55 patients in the nitisinone group and 53 in the control group completed the study. u-HGA 24  at 12 months was significantly decreased by 99·7% in the nitisinone group compared with the control group (adjusted geometric mean ratio of nitisinone/control 0·003 [95% CI 0·003 to 0·004], p<0·0001). At 48 months, the increase in cAKUSSI score from baseline was significantly lower in the nitisinone group compared with the control group (adjusted mean difference -8·6 points [-16·0 to -1·2], p=0·023). 400 adverse events occurred in 59 (86%) patients in the nitisinone group and 284 events occurred in 57 (83%) patients in the control group. No treatment-related deaths occurred.
INTERPRETATION


Nitisinone 10 mg daily was well tolerated and effective in reducing urinary excretion of HGA. Nitisinone decreased ochronosis and improved clinical signs, indicating a slower disease progression.
FUNDING


European Commission Seventh Framework Programme.",2020,u-HGA 24  at 12 months was significantly decreased by 99·7% in the nitisinone group compared with the control group (adjusted geometric mean ratio of nitisinone/control 0·003,"['Patients aged 25 years or older with confirmed alkaptonuria and any clinical disease manifestations', 'patients with alkaptonuria', 'Between May 7, 2014, and Feb 16, 2015, 139 patients were screened, of whom 138 were included in the study, with 69 patients randomly assigned to each group', 'patients with alkaptonuria (SONIA 2', '55 patients in the nitisinone group and 53 in the control group completed the study']","['oral nitisinone 10 mg daily or no treatment', 'once-daily nitisinone']","['cAKUSSI score', 'Clinical evaluation Alkaptonuria Severity Score Index (cAKUSSI) score', 'HGA excretion', 'Efficacy and safety', 'daily urinary HGA excretion', 'efficacy and safety', '400 adverse events', 'urinary excretion of HGA']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0002066', 'cui_str': 'Alkaptonuria'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0173083', 'cui_str': 'nitisinone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1171018', 'cui_str': 'nitisinone 10 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0173083', 'cui_str': 'nitisinone'}]","[{'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0002066', 'cui_str': 'Alkaptonuria'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019881', 'cui_str': 'Homogentisic acid'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",139.0,0.228309,u-HGA 24  at 12 months was significantly decreased by 99·7% in the nitisinone group compared with the control group (adjusted geometric mean ratio of nitisinone/control 0·003,"[{'ForeName': 'Lakshminarayan R', 'Initials': 'LR', 'LastName': 'Ranganath', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK; Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK. Electronic address: lrang@liv.ac.uk.'}, {'ForeName': 'Eftychia Eirini', 'Initials': 'EE', 'LastName': 'Psarelli', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Arnoux', 'Affiliation': 'Hôpital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Braconi', 'Affiliation': 'Department of Biotechnology, Chemistry and Pharmacy, University of Siena, Siena, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Briggs', 'Affiliation': 'Department of Ophthalmology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Bröijersén', 'Affiliation': 'Swedish Orphan Biovitrum, Stockholm, Sweden.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Loftus', 'Affiliation': 'Department of Physiotherapy, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Bygott', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Trevor F', 'Initials': 'TF', 'LastName': 'Cox', 'Affiliation': 'Liverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Davison', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Jane P', 'Initials': 'JP', 'LastName': 'Dillon', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Department of Cardiology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'FitzGerald', 'Affiliation': 'Department of Clinical Pharmacology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Genovese', 'Affiliation': 'Nordic Bioscience, Herlev, Denmark.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Glasova', 'Affiliation': 'Institute of Clinical and Translational Research, Biomedical Research Center, Slovak Academy of Sciences, Bratislava, Slovakia; Institute of Pharmacology and Clinical Pharmacology, Slovak Medical University, Bratislava, Slovakia.'}, {'ForeName': 'Anthony K', 'Initials': 'AK', 'LastName': 'Hall', 'Affiliation': 'Cudos, Hoofddorp, Netherlands.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Hughes', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Juliette H', 'Initials': 'JH', 'LastName': 'Hughes', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Imrich', 'Affiliation': ""Institute of Clinical and Translational Research, Biomedical Research Center, Slovak Academy of Sciences, Bratislava, Slovakia; National Institute of Rheumatic Diseases, Piešt'any, Slovakia.""}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Jarvis', 'Affiliation': 'School of Sport and Exercise Science, Liverpool John Moores University, Liverpool, UK.'}, {'ForeName': 'Milad', 'Initials': 'M', 'LastName': 'Khedr', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Dinny', 'Initials': 'D', 'LastName': 'Laan', 'Affiliation': 'PSR Group, Hoofddorp, Netherlands.'}, {'ForeName': 'Kim-Hanh', 'Initials': 'KH', 'LastName': 'Le Quan Sang', 'Affiliation': 'Hôpital Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Luangrath', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': ""Ol'ga"", 'Initials': 'O', 'LastName': 'Lukáčová', 'Affiliation': ""National Institute of Rheumatic Diseases, Piešt'any, Slovakia.""}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Milan', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Alpesh', 'Initials': 'A', 'LastName': 'Mistry', 'Affiliation': 'Department of Radiology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Vanda', 'Initials': 'V', 'LastName': 'Mlynáriková', 'Affiliation': ""National Institute of Rheumatic Diseases, Piešt'any, Slovakia.""}, {'ForeName': 'Brendan P', 'Initials': 'BP', 'LastName': 'Norman', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Olsson', 'Affiliation': 'Swedish Orphan Biovitrum, Stockholm, Sweden.'}, {'ForeName': 'Nicholas P', 'Initials': 'NP', 'LastName': 'Rhodes', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Rovenský', 'Affiliation': ""National Institute of Rheumatic Diseases, Piešt'any, Slovakia.""}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Rudebeck', 'Affiliation': 'Swedish Orphan Biovitrum, Stockholm, Sweden.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Santucci', 'Affiliation': 'Department of Biotechnology, Chemistry and Pharmacy, University of Siena, Siena, Italy.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Shweihdi', 'Affiliation': 'Department of Clinical Biochemistry and Metabolic Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Ciarán', 'Initials': 'C', 'LastName': 'Scott', 'Affiliation': 'AKU Society, Cambridge, UK.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Sedláková', 'Affiliation': ""National Institute of Rheumatic Diseases, Piešt'any, Slovakia.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Sireau', 'Affiliation': 'AKU Society, Cambridge, UK.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Stančík', 'Affiliation': ""National Institute of Rheumatic Diseases, Piešt'any, Slovakia.""}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Szamosi', 'Affiliation': 'Swedish Orphan Biovitrum, Stockholm, Sweden.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Department of Physiotherapy, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Christa', 'Initials': 'C', 'LastName': 'van Kan', 'Affiliation': 'PSR Group, Hoofddorp, Netherlands.'}, {'ForeName': 'Sobhan', 'Initials': 'S', 'LastName': 'Vinjamuri', 'Affiliation': 'Department of Nuclear Medicine, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Vrtíková', 'Affiliation': ""National Institute of Rheumatic Diseases, Piešt'any, Slovakia.""}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Webb', 'Affiliation': 'Department of Ear, Nose and Throat, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'West', 'Affiliation': 'Department of Dermatology, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Záňová', 'Affiliation': ""National Institute of Rheumatic Diseases, Piešt'any, Slovakia.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Zatkova', 'Affiliation': 'Institute of Clinical and Translational Research, Biomedical Research Center, Slovak Academy of Sciences, Bratislava, Slovakia.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Gallagher', 'Affiliation': 'Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30228-X']
2996,32721580,Hepatic Disorders With the Use of Remdesivir for Coronavirus 2019.,"Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2. Recently, the Food and Drug Agency (FDA) and the European Medicines Agency (EMA) recommended remdesivir for the treatment of patients hospitalized with severe coronavirus disease 2019 (COVID-19) infection. 1 , 2  In the remdesivir clinical development program, some cases have raised concerns regarding potential hepatobiliary disorders associated with remdesivir, including in healthy volunteers and patients with COVID-19. 3  In cohort studies of patients hospitalized for severe COVID-19 who were treated with compassionate-use remdesivir, elevated hepatic enzymes were the most frequent adverse drug reaction reported. 4 , 5  In the first randomized, double-blind, placebo-controlled clinical trial assessing the effect of intravenous remdesivir in adults admitted to hospital with severe COVID-19 (n = 237), a higher proportion of remdesivir recipients than placebo recipients had dosing prematurely stopped by the investigators because of adverse events including aminotransferase or bilirubin increases (3 versus 0). 6  Although there is no signal from the available data of severe hepatotoxicity or drug-induced liver injury in clinical trials, the number of patients exposed to remdesivir was too limited. Therefore, there is an urgent need to investigate the hepatic safety profile associated with remdesivir in COVID-19 patients.",2020,Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2.,"['adults admitted to hospital with severe COVID-19 (n\xa0= 237', 'healthy volunteers and patients with COVID-19', 'recipients had dosing prematurely stopped by the investigators because of adverse events including aminotransferase or bilirubin increases (3 versus 0', 'patients hospitalized with severe coronavirus disease 2019 (COVID-19) infection']",['placebo'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferase'}, {'cui': 'C0311468', 'cui_str': 'Increased bilirubin level'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.110012,Remdesivir is a nucleotide analog prodrug with antiviral activity against a broad spectrum of human coronavirus in cell cultures and mouse models including severe acute respiratory syndrome-associated coronavirus 2.,"[{'ForeName': 'François', 'Initials': 'F', 'LastName': 'Montastruc', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France; INSERM, UMR 1027 Pharmacoepidemiology, Assessment of Drug Utilization and Drug Safety, CIC 1426 - University Paul Sabatier Toulouse, Toulouse, France. Electronic address: francois.montastruc@univ-tlse3.fr.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Thuriot', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Durrieu', 'Affiliation': 'Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France; INSERM, UMR 1027 Pharmacoepidemiology, Assessment of Drug Utilization and Drug Safety, CIC 1426 - University Paul Sabatier Toulouse, Toulouse, France.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.07.050']
2997,32827404,Effects of Brief Guided Imagery on Female Patients Diagnosed with Fibromyalgia: An Exploratory Controlled Trial.,"Objectives


To evaluate the effect of Brief Guided Imagery (BGI) on patients suffering chronic, fibromyalgia-related pain.
Background


Fibromyalgia is characterized by chronic pain and accompanied by fatigue, depression, sleep problems, decreased daily functioning, and a lack of energy, thus negatively impacting daily functions, mental and physical health, and quality of life.
Design


An exploratory, controlled trial.
Setting


The study was conducted at Clalit Health Services (CHS) Physiotherapy Institute, Jerusalem, Israel and approved by the CHS IRB (0015-com2-16).
Methods


Thirty-seven female patients diagnosed with fibromyalgia were alternatively allocated to an intervention group 1 (IG1) including 18 patients, or a control group (CG) including 19 patients. Following the first BGI trial, the 16 remaining participants in CG became intervention group 2 (IG2), and 13 patients completed the trial.
Outcome Measures


All patients completed a Brief Pain Inventory pain questionnaire and an SF-36 satisfaction questionnaire, before and after the intervention.
Results


The findings of this study are encouraging. Training in BGI was found to be related to significant improvement in pain management, general activity, mood, walking ability, routine work, relationships with others, sleep and enjoyment of life. Significant improvements were found for overall pain, as well as for mood and quality of life.
Conclusions


We see a trend of improvement following BGI, but more research is needed to investigate this technique. Significant improvements were found for overall pain, as well as for mood and quality of life. We recommend adding BGI to treatment plans for patients suffering chronic, fibromyalgia-related pain. While other guided imagery methods last up to 20 minutes per session, BGI is innovative since only two minutes are required to obtain a positive effect on chronic pain and quality of life measures.",2020,"Training in BGI was found to be related to significant improvement in pain management, general activity, mood, walking ability, routine work, relationships with others, sleep and enjoyment of life.","['Setting\n\n\nThe study was conducted at Clalit Health Services ', 'patients suffering chronic, fibromyalgia-related pain', 'Methods\n\n\nThirty-seven female patients diagnosed with fibromyalgia', 'Female Patients Diagnosed with Fibromyalgia', '16 remaining participants in CG became intervention group 2 (IG2), and 13 patients completed the trial']","['Brief Guided Imagery', 'Brief Guided Imagery (BGI', 'control group (CG', 'BGI']","['mood and quality of life', 'overall pain', 'pain management, general activity, mood, walking ability, routine work, relationships with others, sleep and enjoyment of life', 'Brief Pain Inventory pain questionnaire and an SF-36 satisfaction questionnaire', 'chronic pain and quality of life measures']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0441655', 'cui_str': 'Activity'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0424131', 'cui_str': 'Enjoyment of life'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",37.0,0.10942,"Training in BGI was found to be related to significant improvement in pain management, general activity, mood, walking ability, routine work, relationships with others, sleep and enjoyment of life.","[{'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Kaplun', 'Affiliation': ''}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Roitman', 'Affiliation': ''}, {'ForeName': 'Tova', 'Initials': 'T', 'LastName': 'Rosenbloom', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
2998,32827410,Nonpharmacological Management of Gestational Diabetes Mellitus: Diaphragmatic Breathing Exercise.,"Context


Gestational diabetes mellitus (GDM) is one of the most common complications during pregnancy. It can lead to physiological reactions that can increase the incidence of preeclampsia and infections, the risk of postpartum bleeding in the short term, and the possibility of conversion Type II diabetes in the long term.
Objectives


The present study intended to determine the effects of diaphragmatic breathing exercises (DBE) on physiological parameters in pregnant women with GDM.
Design


The research team designed a single-blinded, randomized, controlled clinical trial.
Setting


The study was performed at a university hospital in Istanbul, Turkey.
Participants


Participants were 60 pregnant women who suffered from GDM and who attended the antenatal polyclinic at the hospital between June 2015 and June 2016.
Intervention


Participants were divided randomly into 2 groups with 30 participants each, the intervention and control groups. The intervention group practiced DBE for 5 minutes every day; the control group did not. Diet therapy has been recommended to both groups by their obstetrician.
Outcome Measures


The outcome measures were the levels of fasting blood glucose (FBG), and vital measurements were taken from both groups for 30 days. Data analysis was done using SPSS statistical software. Results • The experimental group showed significant decreases in respiratory rate and levels of FBG when compared with the control group. The intervention group's results for pulse rate and systolic and diastolic blood pressure were within normal limits, and no measurable differences existed between the two groups for those measures.
Conclusion


Practicing DBE provided positive effects for pregnant women with gestational diabetes mellitus on the observed physiological parameters.",2020,"The intervention group's results for pulse rate and systolic and diastolic blood pressure were within normal limits, and no measurable differences existed between the two groups for those measures.
","['pregnant women with GDM.\nDesign', 'Gestational Diabetes Mellitus', 'Participants\n\n\nParticipants were 60 pregnant women who suffered from GDM and who attended the antenatal polyclinic at the hospital between June 2015 and June 2016', 'pregnant women with gestational diabetes mellitus', 'Setting\n\n\nThe study was performed at a university hospital in Istanbul, Turkey']","['Diet therapy', 'diaphragmatic breathing exercises (DBE']","['pulse rate and systolic and diastolic blood pressure', 'respiratory rate and levels of FBG', 'levels of fasting blood glucose (FBG), and vital measurements']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}]","[{'cui': 'C0012160', 'cui_str': 'nutritional management'}, {'cui': 'C0454509', 'cui_str': 'Diaphragmatic breathing exercises'}]","[{'cui': 'C0232117', 'cui_str': 'Pulse rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",60.0,0.0472162,"The intervention group's results for pulse rate and systolic and diastolic blood pressure were within normal limits, and no measurable differences existed between the two groups for those measures.
","[{'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Fiskin', 'Affiliation': ''}, {'ForeName': 'Nevin', 'Initials': 'N', 'LastName': 'Sahin', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
2999,32827412,"Safety of NR-INF-02, an Extract of Curcuma Longa Containing Turmerosaccharides, in Healthy Volunteers: A Randomized, Open-label Clinical Trial.","Context


Turmeric (Curcuma longa) is a common medicinal plant used in traditional medicine that also has been scientifically validated for its antioxidant, anti-arthritic, anticancer, analgesic, and anti-inflammatory properties. Researchers have still not much explored the beneficial effects of the curcuminoid-free portion of turmeric. NR-INF-02 is a proprietary, patented aqueous extract of Curcuma longa comprising turmerosaccharides with a novel phytochemical composition.
Objective


The study intended to evaluate the safety and tolerability of NR-INF-02 in healthy adult volunteers at doses of 1000 and 2000 mg, administered for 84 days.
Design


The study employed a randomized, open label, two-arm, parallel-group design.
Setting


The trial was carried at 2 sites, the Meenakshi Multispecialty Hospital in Chennai, Tamil Nadu, India and the Vijaya Super Specialty Hospital in Nellore, Andhra Pradesh, India.
Participants


Participants were healthy adult, male or female volunteers, aged 18-65 years with a body mass index of ≥18.5 kg/m2 and ≤ 24.9 kg/m2 and a body weight of at least 55 kg for men and 48 kg for women.
Intervention


Participants were randomly divided into 2 groups with 24 participants each for a total of 48 participants. They received either 1000 or 2000 mg of NR-INF-02 for 84 days.
Outcome Measures


The incidence of adverse events and the changes from baseline in clinical laboratory parameters-including hematological, biochemical, and urinalysis parameters-were assessed at baseline, at day 42, and postintervention at day 84 as primary endpoints for safety. Secondary endpoints were the changes in vital signs and the difference in the results of an electrocardiogram (ECG) between baseline and days 42 and 84.
Results


The NR-INF-02 at doses of 1000 and 2000 mg demonstrated a 4.17% and 20.83% incidence of adverse events (AEs), respectively. The AEs were mild to moderate and were either probably or possibly related, but not definitively, related to treatment. A detailed examination of hematological, biochemical, and urological parameters and of ECG results and vital signs didn't indicate any untoward effects for any participant.
Conclusion


The study found NR-INF-02 to be safe and tolerable at both tested doses for the given duration of the trial for healthy adult volunteers.",2020,"The NR-INF-02 at doses of 1000 and 2000 mg demonstrated a 4.17% and 20.83% incidence of adverse events (AEs), respectively.","['healthy adult volunteers', 'healthy adult volunteers at doses of 1000 and 2000 mg, administered for 84 days', 'Participants\n\n\nParticipants were healthy adult, male or female volunteers, aged 18-65 years with a body mass index of ≥18.5 kg/m2 and ≤ 24.9 kg/m2 and a body weight of at least 55 kg for men and 48 kg for women', 'Healthy Volunteers', 'Setting\n\n\nThe trial was carried at 2 sites, the Meenakshi Multispecialty Hospital in Chennai, Tamil Nadu, India and the Vijaya Super Specialty Hospital in Nellore, Andhra Pradesh, India', 'Intervention\n\n\nParticipants were randomly divided into 2 groups with 24 participants each for a total of 48 participants']",['NR-INF-02'],"['clinical laboratory parameters-including hematological, biochemical, and urinalysis parameters', 'incidence of adverse events', 'safety and tolerability', 'changes in vital signs and the difference in the results of an electrocardiogram (ECG']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039285', 'cui_str': 'Tamil language'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0037778', 'cui_str': 'Medical specialty'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",48.0,0.142625,"The NR-INF-02 at doses of 1000 and 2000 mg demonstrated a 4.17% and 20.83% incidence of adverse events (AEs), respectively.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Selvi', 'Affiliation': ''}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Mohan Mv', 'Affiliation': ''}, {'ForeName': 'Bharathi', 'Initials': 'B', 'LastName': 'Bethapudi', 'Affiliation': ''}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Mundkinajeddu', 'Affiliation': ''}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Kumari', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
3000,32827413,Aromatherapy Massage for Pain and Xerosis After Repeated Needle Insertion Into a Fistula Arm in Hemodialysis.,"Context


Repeated needle insertion into the fistula causes dry skin in hemodialysis (HD) patients. Dry skin can add to the acute pain from needle by increasing skin irritability.
Objective


The aim of this study was to determine the effects of aromatherapy massage on acute pain and dry skin following needle insertion into an arteriovenous fistula in patients undergoing HD.
Methods


The study was designed as a randomized controlled trial.
Setting


The study took place at a dialysis center in a city center in Central Anatolia in Turkey.
Participants


Participants were patients with arteriovenous fistulas who were undergoing HD at the dialysis center.
Intervention


The 75 patients were randomly divided into 3 groups of 25 each: (1) the aromatherapy massage group received massage 3 times per week for a period of 4 weeks, for 12 sessions in total; (2) the olive-oil massage group also received 12 sessions of massage therapy on the same schedule; (3) the control group received only standard care.
Outcome Measures


The study measured pain levels using a visual analog scale (VAS) and skin moisture using a skin moisture analyzer.
Results


The mean VAS scores for acute pain of the aromatherapy and olive-oil massage groups postintervention were significantly lower than those of the control group (P < .001). The average skin-moisture scores of the aromatherapy-massage group were significantly higher postintervention and at the eight-week follow-up than those of the control and olive-oil massage groups (P < .01). In addition, at the end of 8 weeks, the mean VAS pain scores were significantly lower and the skin-moisture scores were significantly higher in the aromatherapy-massage group compared to the control and olive-oil massage groups (P < .01).
Conclusions


Aromatherapy massage can be an effective nursing practice to manage acute pain and dry skin from needle insertion at the site of an arteriovenous fistula in HD units. Further randomized controlled trials are needed.",2020,The mean VAS scores for acute pain of the aromatherapy and olive-oil massage groups postintervention were significantly lower than those of the control group (P < .001).,"['dialysis center in a city center in Central Anatolia in Turkey', '75 patients', 'hemodialysis (HD) patients', 'patients undergoing HD', 'Participants\n\n\nParticipants were patients with arteriovenous fistulas who were undergoing HD at the dialysis center']","['aromatherapy and olive-oil massage', 'Aromatherapy massage', 'control group received only standard care', 'aromatherapy massage', 'control and olive-oil massage', 'olive-oil massage', 'aromatherapy massage group received massage 3 times per week for a period of 4 weeks, for 12 sessions in total; (2) the olive-oil massage group also received 12 sessions of massage therapy', 'Aromatherapy Massage']","['mean VAS pain scores', 'mean VAS scores for acute pain', 'skin-moisture scores', 'pain levels using a visual analog scale (VAS) and skin moisture using a skin moisture analyzer', 'average skin-moisture scores', 'Pain and Xerosis', 'acute pain and dry skin']","[{'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0003855', 'cui_str': 'Arteriovenous fistula'}]","[{'cui': 'C0376547', 'cui_str': 'Aromatherapy'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C2585844', 'cui_str': 'Aromatherapy massage'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3536731', 'cui_str': 'Massage physiotherapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0179038', 'cui_str': 'Analyzer'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0259817', 'cui_str': 'Xerosis'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}]",75.0,0.0176489,The mean VAS scores for acute pain of the aromatherapy and olive-oil massage groups postintervention were significantly lower than those of the control group (P < .001).,"[{'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Kılıç Akça', 'Affiliation': ''}, {'ForeName': 'Gokcen Aydın', 'Initials': 'GA', 'LastName': 'Akbuga', 'Affiliation': ''}, {'ForeName': 'Dilek Efe', 'Initials': 'DE', 'LastName': 'Arslan', 'Affiliation': ''}, {'ForeName': 'Sibel', 'Initials': 'S', 'LastName': 'Şentürk', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
3001,32827458,Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and Design of a Cluster-Randomized Trial.,"BACKGROUND


The Systolic Blood Pressure Intervention Trial (SPRINT) reported intensive blood pressure (BP) treatment reduced cardiovascular disease and mortality compared to standard BP treatment in hypertension patients. The next important question is how to implement more intensive BP treatment in real-world clinical practice. We designed an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multifaceted intervention for intensive BP treatment and its feasibility, fidelity, and sustainability in underserved hypertension patients.
METHODS


Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS) is a cluster randomized trial conducted in 36 Federally Qualified Health Center (FQHC) clinics in Louisiana and Mississippi. FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care. Difference in mean systolic BP change from baseline to 18 months is the primary clinical effectiveness outcome, and intervention fidelity, measured by treatment intensification and medication adherence, is the primary implementation outcome. The planned sample size of 1,260 participants (36 clinics with 35 participants each) has 90% power to detect a 5.0 mmHg difference in systolic BP at a 0.05 significance level and 80% follow-up rate.
CONCLUSIONS


IMPACTS will generate critical data on the effectiveness and implementation of a multifaceted intervention for intensive BP treatment in real-world clinical practice and could directly impact the BP-related disease burden in minority and low-income populations in the US.",2020,"FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care.","['hypertension patients', '36 Federally Qualified Health Center (FQHC) clinics in Louisiana and Mississippi', 'FQHC clinics', 'underserved hypertension patients', '1,260 participants (36 clinics with 35 participants each']","['Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS', 'multifaceted intervention', 'multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care', 'intensive blood pressure (BP']","['feasibility, fidelity, and sustainability', 'systolic BP', 'mean systolic BP change', 'cardiovascular disease and mortality']","[{'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C0026221', 'cui_str': 'Mississippi'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1272452', 'cui_str': 'Blood pressure taking management'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1449681', 'cui_str': 'Home Blood Pressure Monitoring'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",1260.0,0.0928859,"FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care.","[{'ForeName': 'Katherine T', 'Initials': 'KT', 'LastName': 'Mills', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Institute, New Orleans, LA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Peacock', 'Affiliation': 'Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences; Institute, New Orleans, LA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine.'}, {'ForeName': 'Kenya', 'Initials': 'K', 'LastName': 'Brooks', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Institute, New Orleans, LA.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Cyprian', 'Affiliation': 'Southeast Community Health Systems, Greensburg, LA.'}, {'ForeName': 'Gerrelda', 'Initials': 'G', 'LastName': 'Davis', 'Affiliation': 'Louisiana Primary Care Association, Baton Rouge, LA.'}, {'ForeName': 'Sonja R', 'Initials': 'SR', 'LastName': 'Fuqua', 'Affiliation': 'Community Health Center Association of Mississippi, Jackson, MS.'}, {'ForeName': 'Angelique', 'Initials': 'A', 'LastName': 'Greer', 'Affiliation': 'Coastal Family Health Center, Biloxi, MS.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Gray-Winfrey', 'Affiliation': 'EXCELth, Inc., New Orleans, LA.'}, {'ForeName': 'Shondra', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'InclusivCare, Avondale, LA.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Wiltz', 'Affiliation': 'Teche Action Board, Inc., Franklin, LA.'}, {'ForeName': 'Keith L', 'Initials': 'KL', 'LastName': 'Winfrey', 'Affiliation': 'NOELA Community Health Center, New Orleans, LA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Whelton', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences; Institute, New Orleans, LA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Krousel-Wood', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences; Institute, New Orleans, LA.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine; Department of Medicine, Tulane University School of Medicine, and Tulane University Translational Sciences; Institute, New Orleans, LA. Electronic address: jhe@tulane.edu.'}]",American heart journal,['10.1016/j.ahj.2020.08.009']
3002,32827483,"Low-cost oral metronomic chemotherapy versus intravenous cisplatin in patients with recurrent, metastatic, inoperable head and neck carcinoma: an open-label, parallel-group, non-inferiority, randomised, phase 3 trial.","BACKGROUND


Regimens for palliation in patients with head and neck cancer recommended by the US National Comprehensive Cancer Network (NCCN) have low applicability (less than 1-3%) in low-income and middle-income countries (LMICs) because of their cost. In a previous phase 2 study, patients with head and neck cancer who received metronomic chemotherapy had better outcomes when compared with those who received intravenous cisplatin, which is commonly used as the standard of care in LMICs. We aimed to do a phase 3 study to substantiate these findings.
METHODS


We did an open-label, parallel-group, non-inferiority, randomised, phase 3 trial at the Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India. We enrolled adult patients (aged 18-70 years) who planned to receive palliative systemic treatment for relapsed, recurrent, or newly diagnosed squamous cell carcinoma of the head and neck, and who had an Eastern Cooperative Oncology Group performance status score of 0-1 and measurable disease, as defined by the Response Evaluation Criteria In Solid Tumors. We randomly assigned (1:1) participants to receive either oral metronomic chemotherapy, consisting of 15 mg/m 2  methotrexate once per week plus 200 mg celecoxib twice per day until disease progression or until the development of intolerable side-effects, or 75 mg/m 2  intravenous cisplatin once every 3 weeks for six cycles. Randomisation was done by use of a computer-generated randomisation sequence, with a block size of four, and patients were stratified by primary tumour site and previous cancer-directed treatment. The primary endpoint was median overall survival. Assuming that 6-month overall survival in the intravenous cisplatin group would be 40%, a non-inferiority margin of 13% was defined. Both intention-to-treat and per-protocol analyses were done. All patients who completed at least one cycle of the assigned treatment were included in the safety analysis. This trial is registered with the Clinical Trials Registry-India, CTRI/2015/11/006388, and is completed.
FINDINGS


Between May 16, 2016, and Jan 17, 2020, 422 patients were randomly assigned: 213 to the oral metronomic chemotherapy group and 209 to the intravenous cisplatin group. All 422 patients were included in the intention-to-treat analysis, and 418 patients (211 in the oral metronomic chemotherapy group and 207 in the intravenous cisplatin group) were included in the per-protocol analysis. At a median follow-up of 15·73 months, median overall survival in the intention-to-treat analysis population was 7·5 months (IQR 4·6-12·6) in the oral metronomic chemotherapy group compared with 6·1 months (3·2-9·6) in the intravenous cisplatin group (unadjusted HR for death 0·773 [95% CI 0·615-0·97, p=0·026]). In the per-protocol analysis population, median overall survival was 7·5 months (4·7-12·8) in the oral metronomic chemotherapy group and 6·1 months (3·4-9·6) in the intravenous cisplatin group (unadjusted HR for death 0·775 [95% CI 0·616-0·974, p=0·029]). Grade 3 or higher adverse events were observed in 37 (19%) of 196 patients in the oral metronomic chemotherapy group versus 61 (30%) of 202 patients in the intravenous cisplatin group (p=0·01).
INTERPRETATION


Oral metronomic chemotherapy is non-inferior to intravenous cisplatin with respect to overall survival in head and neck cancer in the palliative setting, and is associated with fewer adverse events. It therefore represents a new alternative standard of care if current NCCN-approved options for palliative therapy are not feasible.
FUNDING


Tata Memorial Center Research Administration Council.
TRANSLATIONS


For the Hindi, Marathi, Gujarati, Kannada, Malayalam, Telugu, Oriya, Bengali, and Punjabi translations of the abstract see Supplementary Materials section.",2020,"INTERPRETATION


Oral metronomic chemotherapy is non-inferior to intravenous cisplatin with respect to overall survival in head and neck cancer in the palliative setting, and is associated with fewer adverse events.","['patients with recurrent, metastatic, inoperable head and neck carcinoma', 'All 422 patients were included in the intention-to-treat analysis, and 418 patients (211 in the oral metronomic chemotherapy group and 207 in the intravenous cisplatin group) were included in the per-protocol analysis', 'Between May 16, 2016, and Jan 17, 2020, 422 patients were randomly assigned: 213 to the', 'patients with head and neck cancer', 'enrolled adult patients (aged 18-70 years) who planned to receive palliative systemic treatment for relapsed, recurrent, or newly diagnosed squamous cell carcinoma of the head and neck, and who had an Eastern Cooperative Oncology Group performance status score of 0-1 and measurable disease, as defined by the Response Evaluation Criteria In Solid Tumors', 'patients with head and neck cancer who received']","['intravenous cisplatin', 'oral metronomic chemotherapy, consisting of 15 mg/m 2  methotrexate', 'oral metronomic chemotherapy', 'metronomic chemotherapy', 'cisplatin', 'celecoxib', 'Low-cost oral metronomic chemotherapy']","['Grade 3 or higher adverse events', 'overall survival', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0007097', 'cui_str': 'Carcinoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",422.0,0.319059,"INTERPRETATION


Oral metronomic chemotherapy is non-inferior to intravenous cisplatin with respect to overall survival in head and neck cancer in the palliative setting, and is associated with fewer adverse events.","[{'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Patil', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Vanita', 'Initials': 'V', 'LastName': 'Noronha', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Sachin Babanrao', 'Initials': 'SB', 'LastName': 'Dhumal', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Nandini', 'Initials': 'N', 'LastName': 'Menon', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Atanu', 'Initials': 'A', 'LastName': 'Bhattacharjee', 'Affiliation': 'Section of Biostatistics, Centre for Cancer Epidemiology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Suyash', 'Initials': 'S', 'LastName': 'Kulkarni', 'Affiliation': 'Department of Radiodiagnosis, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Suman Kumar', 'Initials': 'SK', 'LastName': 'Ankathi', 'Affiliation': 'Department of Radiodiagnosis, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Mahajan', 'Affiliation': 'Department of Radiodiagnosis, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Nilesh', 'Initials': 'N', 'LastName': 'Sable', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Kavita', 'Initials': 'K', 'LastName': 'Nawale', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Arti', 'Initials': 'A', 'LastName': 'Bhelekar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Sadaf', 'Initials': 'S', 'LastName': 'Mukadam', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Chandrasekharan', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Sudeep', 'Initials': 'S', 'LastName': 'Das', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Dilip', 'Initials': 'D', 'LastName': 'Vallathol', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Hollis', 'Initials': 'H', 'LastName': ""D'Souza"", 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Agrawal', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Satvik', 'Initials': 'S', 'LastName': 'Khaddar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Narmadha', 'Initials': 'N', 'LastName': 'Rathnasamy', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Ramnath', 'Initials': 'R', 'LastName': 'Shenoy', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Lakhan', 'Initials': 'L', 'LastName': 'Kashyap', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Rahul Kumar', 'Initials': 'RK', 'LastName': 'Rai', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Abraham', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Saswata', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Swaratika', 'Initials': 'S', 'LastName': 'Majumdar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Karuvandan', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Vijai', 'Initials': 'V', 'LastName': 'Simha', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Vasu', 'Initials': 'V', 'LastName': 'Babu', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Prahalad', 'Initials': 'P', 'LastName': 'Elamarthi', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Annu', 'Initials': 'A', 'LastName': 'Rajpurohit', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Kanteti Aditya Pavan', 'Initials': 'KAP', 'LastName': 'Kumar', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Srikanth', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Ravind', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Shripad', 'Initials': 'S', 'LastName': 'Banavali', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India.'}, {'ForeName': 'Kumar', 'Initials': 'K', 'LastName': 'Prabhash', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Homi Bhabha National Institute, Mumbai, India. Electronic address: id-kumarprabhashtmh@gmail.com.'}]",The Lancet. Global health,['10.1016/S2214-109X(20)30275-8']
3003,32827501,Intranasal vasopressin expedites dishonesty in females.,"As an integral ingredient of human sociality, dishonesty can be both egocentric and altruistic, as well as gradually escalate. Here, we examined the influence of arginine vasopressin (AVP), a neuropeptide associated with human prosocial behaviors, on dishonest behaviors in males and females. In this double-blind and placebo-controlled study, 101 participants were randomized to administration of either 20 IU intranasal AVP or placebo. We used a two-party task to manipulate the incentive structure of dishonesty in the way of self-/other-serving repeatedly. For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP. The dishonest behavior of females treated with AVP gradually escalated with repetition over time. These results suggest that AVP selectively regulates the escalation of dishonesty in females, contingent on the motivation of dishonesty. Our findings provide insight into sex-specific modulations of AVP on human dishonest behavior.",2020,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","['females', '101 participants', 'males and females']","['Intranasal vasopressin', 'intranasal AVP', 'AVP', 'intranasal placebo', '20\u202fIU intranasal AVP or placebo', 'arginine vasopressin (AVP', 'placebo']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],101.0,0.145508,"For lies that benefit both themselves and others, females receiving intranasal AVP lied more than females receiving intranasal placebo and males receiving intranasal AVP.","[{'ForeName': 'Chunliang', 'Initials': 'C', 'LastName': 'Feng', 'Affiliation': 'Key Laboratory of Brain, Cognition and Education Sciences, Ministry of Education, School of Psychology, Center for Studies of Psychological Application, Guangdong Key Laboratory of Mental Health and Cognitive Science, South China Normal University, China. Electronic address: chunliang.feng@m.scnu.edu.cn.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Qin', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Yuejia', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China.'}, {'ForeName': 'Pengfei', 'Initials': 'P', 'LastName': 'Xu', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Neuroscience, Center for Brain Disorders and Cognitive Sciences, Shenzhen University, Shenzhen, China; Center for Emotion and Brain, Shenzhen Institute of Neuroscience, Shenzhen, China; Great Bay Neuroscience and Technology Research Institute (Hong Kong), Kwun Tong, Hong Kong, China. Electronic address: xupf@szu.edu.cn.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104843']
3004,32827517,"Ropinirole, a dopamine agonist with high D 3  affinity, reduces proactive inhibition: A double-blind, placebo-controlled study in healthy adults.","Response inhibition describes the cognitive processes mediating the suppression of unwanted actions. A network involving the basal ganglia mediates two forms of response inhibition: reactive and proactive inhibition. Reactive inhibition serves to abruptly stop motor activity, whereas proactive inhibition is goal-orientated and results in slowing of motor activity in anticipation of stopping. Due to its impairment in several psychiatric disorders, the neurochemistry of response inhibition has become of recent interest. Dopamine has been posed as a candidate mediator of response inhibition due to its role in functioning of the basal ganglia and the observation that patients with Parkinson's disease on dopamine agonists develop impulse control disorders. Although the effects of dopamine on reactive inhibition have been studied, substantial literature on the role of dopamine on proactive inhibition is lacking. To fill this gap, we devised a double-blind, placebo-controlled study of 1 mg ropinirole (a dopamine agonist) on response inhibition in healthy volunteers. We found that whilst reactive inhibition was unchanged, proactive inhibition was impaired when participants were on ropinirole relative to when on placebo. To investigate how ropinirole mediated this effect on proactive inhibition, we used hierarchical drift-diffusion modelling. We found that ropinirole impaired the ability to raise the decision threshold when proactive inhibition was called upon. Our results provide novel evidence that an acute dose of ropinirole selectively reduces proactive inhibition in healthy participants. These results may help explain how ropinirole induces impulse control disorders in susceptible patients with Parkinson's disease.",2020,"We found that whilst reactive inhibition was unchanged, proactive inhibition was impaired when participants were on ropinirole relative to when on placebo.","[""susceptible patients with Parkinson's disease"", 'healthy volunteers', ""patients with Parkinson's disease on dopamine agonists develop impulse control disorders"", 'healthy adults', 'healthy participants']","['Dopamine', 'Ropinirole', 'ropinirole', 'ropinirole (a dopamine agonist', 'dopamine', 'placebo']","['reactive inhibition', 'proactive inhibition']","[{'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0021122', 'cui_str': 'Impulse control disorder'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0244821', 'cui_str': 'ropinirole'}, {'cui': 'C0178601', 'cui_str': 'Dopamine receptor agonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034750', 'cui_str': 'Inhibition, Reactive'}, {'cui': 'C0033199', 'cui_str': 'Inhibition, Proactive'}]",,0.116831,"We found that whilst reactive inhibition was unchanged, proactive inhibition was impaired when participants were on ropinirole relative to when on placebo.","[{'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Rawji', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK. Electronic address: vishal.rawji.11@ucl.ac.uk.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Rocchi', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Foltynie', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Rothwell', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Jahanshahi', 'Affiliation': 'Department of Clinical and Movement Neurosciences, UCL Queen Square Institute of Neurology, Queen Square, London, UK.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108278']
3005,32827526,Randomized Controlled Trial of Working Memory Intervention in Congenital Heart Disease.,"OBJECTIVES


To evaluate the efficacy of Cogmed Working Memory Training compared with the standard of care to improve executive function and social outcomes in adolescents with congenital heart disease (CHD) who underwent open-heart surgery in infancy and to identify factors associated with changes in outcomes following the intervention.
STUDY DESIGN


In a single-center, randomized controlled trial, adolescents (13-16 years) with CHD were randomly assigned to either Cogmed (home-based 45-minutes sessions for 5-8 weeks) or to a control group. The primary outcome was working memory. Secondary outcomes included inhibitory control and cognitive flexibility as well as parent-reported executive function, ADHD symptoms and social outcomes. All measures were assessed at baseline, post-treatment (1-3 weeks post-training) and at 3-month follow-up. Data were analyzed using an intention-to-treat approach.
RESULTS


Sixty adolescents with CHD participated (28 assigned to Cogmed). No improvement at the post-treatment or 3-month follow-up assessments was found for the primary outcome measure of working memory. Compared with the control group, participants assigned to the intervention demonstrated benefits in inhibitory control and attention at the 3-month follow-up (p=0.02) and in parent-reported cognitive regulatory skills at post-treatment and 3-month follow-up (p=0.02 and p=0.04, respectively). Preterm birth, biventricular CHD and history of ADHD diagnosis were associated with improved response to the intervention.
CONCLUSIONS


Cogmed intervention produced improvements in the self-regulatory control abilities of adolescents with CHD. The training did not enhance other areas of executive function or behavioral outcomes. Further studies are needed to evaluate the longer-term potential benefits to other domains.",2020,No improvement at the post-treatment or 3-month follow-up assessments was found for the primary outcome measure of working memory.,"['Congenital Heart Disease', 'adolescents (13-16 years) with CHD', 'Sixty adolescents with CHD participated (28 assigned to Cogmed', 'adolescents with CHD', 'adolescents with congenital heart disease (CHD) who underwent open-heart surgery in infancy']","['Cogmed Working Memory Training', 'Working Memory Intervention']","['self-regulatory control abilities', 'executive function and social outcomes', 'Preterm birth, biventricular CHD and history of ADHD diagnosis', 'working memory', 'inhibitory control and cognitive flexibility as well as parent-reported executive function, ADHD symptoms and social outcomes', 'executive function or behavioral outcomes', 'cognitive regulatory skills']","[{'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0189745', 'cui_str': 'Open heart surgery'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",60.0,0.0945375,No improvement at the post-treatment or 3-month follow-up assessments was found for the primary outcome measure of working memory.,"[{'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Calderon', 'Affiliation': ""Department of Psychiatry, Boston Children's Hospital, Boston, MA; Department of Psychiatry, Harvard Medical School, Boston, MA. Electronic address: johanna.calderon@childrens.harvard.edu.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wypij', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA; Department of Biostatistics. Harvard T.H. Chan School of Public Health, Boston, MA; Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Rofeberg', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Stopp', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Roseman', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Albers', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA.""}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Newburger', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA; Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Bellinger', 'Affiliation': ""Department of Psychiatry, Boston Children's Hospital, Boston, MA; Department of Psychiatry, Harvard Medical School, Boston, MA; Department of Neurology, Boston Children's Hospital, Boston, MA; Department of Neurology, Harvard Medical School, Boston, MA.""}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.08.038']
3006,32827553,"Effect of Adding Neural Mobilization versus Myofascial Release to Stabilization Exercises after Lumbar Spine Fusion: A single blinded, parallel groups, Randomized Controlled Trial.","OBJECTIVES


To test the effect of adding neural mobilization (NM) versus myofascial release (MFR) to stabilization exercises (SE) on disability, pain, and lumbar range of motion (ROM) in patients with lumbar spine fusion (LSF).
DESIGN


A single blinded, Parallel groups, randomized controlled trial.
SETTINGS


Outpatient public and governmental hospitals Clinics.
PARTICIPANTS


Sixty patients who have undergone lumbar spine fusion were randomly assigned into three equal groups.
INTERVENTION


Group (I) received neural mobilization plus stabilization exercises, group (II) received myofascial release and stabilization exercises, and group (III) received stabilization exercises only. Each group received 3 visits a week for four weeks.
MAIN OUTCOME MEASURES


Oswestry disability index (ODI), visual analogue scale (VAS), and back range of motion device (BROM) were assessed before starting treatment, after finishing treatment and one month later as a follow up.
RESULTS


There were Statistically significant differences among the groups regarding the ODI and pain (P<0.05) in favor of the study groups, but no statistically significant differences were found among groups regarding the BROM outcome (P>0.05). Regarding the within-group effect, statistically significant differences were found in all outcomes after 1 month of treatment, as well as, after 1 month of follow up in each group(P>0.05).
CONCLUSION


Patients who received NM or MFR combined with SE had better improvement, in favor of the NM group, regarding disability and pain than patients who received SE alone after LSF. No differences were found among the groups regarding lumbar ROM.",2020,"There were Statistically significant differences among the groups regarding the ODI and pain (P<0.05) in favor of the study groups, but no statistically significant differences were found among groups regarding the BROM outcome (P>0.05).","['after Lumbar Spine Fusion', 'Sixty patients who have undergone lumbar spine fusion', 'patients with lumbar spine fusion (LSF', 'Outpatient public and governmental hospitals Clinics']","['neural mobilization (NM) versus myofascial release (MFR) to stabilization exercises (SE', 'Adding Neural Mobilization versus Myofascial Release to Stabilization Exercises', 'neural mobilization plus stabilization exercises, group (II) received myofascial release and stabilization exercises, and group (III) received stabilization exercises only']","['disability and pain', 'Oswestry disability index (ODI), visual analogue scale (VAS), and back range of motion device (BROM', 'lumbar ROM', 'BROM outcome', 'ODI and pain', 'disability, pain, and lumbar range of motion (ROM']","[{'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0587906', 'cui_str': 'Hospital clinic'}]","[{'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.0668133,"There were Statistically significant differences among the groups regarding the ODI and pain (P<0.05) in favor of the study groups, but no statistically significant differences were found among groups regarding the BROM outcome (P>0.05).","[{'ForeName': 'Mohsen Mohamed', 'Initials': 'MM', 'LastName': 'Elsayyad', 'Affiliation': 'Professor, Department of Physical Therapy for Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Nabil Mahmoud', 'Initials': 'NM', 'LastName': 'Abdel-Aal', 'Affiliation': 'Lecturer, Department of Physical Therapy for Basic Sciences, Faculty of Physical Therapy, Cairo University, Giza, Egypt. Electronic address: nabil.mahmoud@cu.edu.eg.'}, {'ForeName': 'Mohamed Elsayed', 'Initials': 'ME', 'LastName': 'Helal', 'Affiliation': 'Physical Therapist, Department of Physical Therapy, Sadat general hospital, Monofia, Egypt.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.07.009']
3007,32827564,Simultaneous splenectomy improves outcomes after adult living donor liver transplantation.,"BACKGROUND AIMS


Small-for-size graft (SFSG) syndrome is a main causes of graft loss in living donor liver transplantation (LDLT). Splenectomy (Spx) is an option to prevent this catastrophic complication, but its effect remains controversial. To date, there has been no prospective randomized study to clarify the impact of Spx. The aim of this study was to compare graft function and long-term outcomes of Spx with no portal flow modulation during LDLT between two matched groups.
METHODS


Three hundred and twenty patients were divided into two groups: with Spx (n=258) and without Spx (n=62). To overcome selection bias, one-to-one matching using propensity score matching (PSM) was performed (n=50, in each group).
RESULTS


Recipients with simultaneous Spx showed better graft function on post-operative-day (POD) 7, 14 and lower sepsis frequency within 6 months after LDLT, and better graft survival rates compared with those without Spx before matching. After PSM, recipients with simultaneous Spx showed lower early graft dysfunction frequency on POD 7 (p=0.04), lower SFSG syndrome frequency (p=0.01), lower serum total bilirubin levels (p=0.001), and lower international normalized ratio (p=0.004) on POD 14, lower sepsis (p=0.02) frequency within 6 months after LDLT, and better graft survival rates (p=0.04) compared with those without Spx. Univariate analysis revealed that without Spx (hazard ratio=3.06, 95% confidence intervals:1.07 - 11.0, p=0.037) was the only risk factor for graft loss after LDLT.
CONCLUSIONS


Simultaneous Spx may prevent SFSG syndrome and is a predictive factor for graft survival after LDLT. Simultaneous Spx is recommended when a small graft (GW/SLW 35% or less) is predicted preoperatively, or for patients with portal hypertension or high portal pressure (above 20 mmHg) after reperfusion in LDLT.",2020,"Univariate analysis revealed that without Spx (hazard ratio=3.06, 95% confidence intervals:1.07 - 11.0, p=0.037) was the only risk factor for graft loss after LDLT.
","['patients with portal hypertension or high portal pressure (above 20 mmHg) after reperfusion in LDLT', 'Three hundred and twenty patients were divided into two groups: with Spx (n=258) and without Spx (n=62', 'living donor liver transplantation (LDLT', 'adult living donor liver transplantation']","['Splenectomy (Spx', 'Simultaneous splenectomy']","['lower SFSG syndrome frequency', 'lower early graft dysfunction frequency', 'graft function', 'sepsis frequency', 'serum total bilirubin levels', 'graft survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020541', 'cui_str': 'Portal hypertension'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0162523', 'cui_str': 'Portal Venous Pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0302512', 'cui_str': 'Donor for liver transplant'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0037995', 'cui_str': 'Splenectomy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}]","[{'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1167870', 'cui_str': 'Transplant dysfunction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C1278039', 'cui_str': 'Serum total bilirubin measurement'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}]",320.0,0.195908,"Univariate analysis revealed that without Spx (hazard ratio=3.06, 95% confidence intervals:1.07 - 11.0, p=0.037) was the only risk factor for graft loss after LDLT.
","[{'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Yoshizumi', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, 812-8582, Japan. Electronic address: tomyoshi@surg2.med.kyushu-u.ac.jp.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Itoh', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Mototsugu', 'Initials': 'M', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Shoichi', 'Initials': 'S', 'LastName': 'Inokuchi', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Noboru', 'Initials': 'N', 'LastName': 'Harada', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Takeishi', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Mano', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Yoshiya', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kurihara', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Nagao', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Ikegami', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Soejima', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, 812-8582, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, 812-8582, Japan.'}]",Journal of hepatology,['10.1016/j.jhep.2020.08.017']
3008,32827598,Parental-oriented educational mobile messages to aid in the control of early childhood caries in low socioeconomic children: a randomized controlled trial: Effectiveness of a parental-oriented mobile text messages to early childhood caries control.,"OBJECTIVES


To evaluate the effectiveness of educational messages as an aid in the control of early childhood caries (ECC) in low socioeconomic children.
METHODS


A single-blinded, randomized, and parallel-group study was conducted with 104 dyads of parents and children aged between 36-60 months, recruited in preschools from (blinded). The participants were randomly allocated into control and intervention groups (1:1), stratified by eHealth literacy scores (eHEALS) of parents and caries experience of children. Each 2 weeks, text messages were sent to parents of intervention group via WhatsApp. Visible plaque index (VPI) and the International Caries Detection and Assessment System (ICDAS) were assessed at baseline, 3- and 6-month follow-up, while eHEALS and dietary habits were determined at baseline and 6-month follow-up. Statistical analysis was performed to intra and intergroup comparisons through Fischer´s exact and McNemar tests, and Mann-Whitney U and Friedman tests, respectively (P < 0.05).
RESULTS


Despite similarities between groups, intervention increased parental eHEALS scores, influenced the reports about the children's consumption of sugar-free sweets and controlled the severity of ECC.
CONCLUSION


Therefore, mobile text messages were effective to control the severity of ECC in low socioeconomic preschoolers, improving parental eHealth literacy and changing children's dietary patterns.
CLINICAL SIGNIFICANCE


These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.",2020,These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.,"['low socioeconomic children', '104 dyads of parents and children aged between 36-60 months, recruited in preschools from (blinded']","['educational messages', 'parental-oriented mobile text messages', 'Parental-oriented educational mobile messages']","['Visible plaque index (VPI) and the International Caries Detection and Assessment System (ICDAS', 'parental eHEALS scores']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0747732,These findings demonstrate that parental-oriented WhatsApp messages can contribute to oral health education of socioeconomic vulnerable parents towards risk behavior changes to control ECC.,"[{'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Lotto', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Anna Paola', 'Initials': 'AP', 'LastName': 'Strieder', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Patricia Estefania', 'Initials': 'PE', 'LastName': 'Ayala Aguirre', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Thais Marchini', 'Initials': 'TM', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Maria Aparecida', 'Initials': 'MA', 'LastName': 'de Andrade Moreira Machado', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rios', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil.'}, {'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Cruvinel', 'Affiliation': 'Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Alameda Dr. Octávio Pinheiro Brisolla, 9-75, Vila Universitária, Bauru, SP, 17012-901, Brazil. Electronic address: thiagocruvinel@fob.usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103456']
3009,32827835,Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants.,"AIM


The quadrivalent human papillomavirus (4vHPV) vaccine has demonstrated efficacy and immunogenicity and was generally well tolerated in clinical trials conducted in Japan. We report a detailed safety analysis of injection-site reactions in female Japanese 4vHPV clinical trial participants.
METHODS


This post-hoc analysis included data from 2 double-blind, placebo-controlled phase II clinical trials of a 3-dose (Day 1, Month 2, Month 6) regimen of 4vHPV vaccine in Japanese young women aged 18-26 years (N = 1021; NCT00378560) and girls aged 9-17 years (N = 107; NCT00411749). Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials. Post-hoc analyses of data from these trials were performed to examine details of injection-site AEs, including day of onset, time from onset to resolution, and maximum intensity.
RESULTS


Injection-site AEs were reported by 85.6% of 4vHPV vaccine recipients and 72.4% of placebo recipients, most commonly erythema, pain, pruritus, and swelling (each >5% of 4vHPV vaccine recipients). The majority of injection-site AEs had an onset within 3 days of vaccination and were mild to moderate in intensity; few 4vHPV vaccine recipients reported severe injection-site AEs (2.0% overall). All injection-site AEs resolved, and most (4vHPV: 87.5%; placebo: 92.7%) resolved within 5 days of onset.
CONCLUSIONS


Most injection-site reactions are mild or moderate in intensity and of short duration. The 3-dose regimen of 4vHPV vaccine is well tolerated in Japanese female clinical trial participants based on this post-hoc analysis. These results will further support safety communication between healthcare providers and vaccine recipients regarding the HPV vaccine.
TRIAL REGISTRATION


Clinicaltrials. gov: NCT00378560 and NCT00411749.",2020,Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials.,"['female Japanese 4vHPV clinical trial participants', 'Japanese female clinical trial participants', 'Japanese young women aged 18-26 years (N\u202f=\u202f1021; NCT00378560) and girls aged 9-17 years (N\u202f=\u202f107; NCT00411749']","['vaccination with quadrivalent human papillomavirus vaccine', 'injection-site reactions', '4vHPV vaccine', 'quadrivalent human papillomavirus (4vHPV) vaccine', 'placebo']","['severe injection-site AEs', 'erythema, pain, pruritus, and swelling ']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517529', 'cui_str': '107'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1815829', 'cui_str': 'Human papillomavirus type 6, 11, 16, and 18 vaccine'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}]",,0.597729,Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials.,"[{'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Murata', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: shinya.murata@merck.com.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Shirakawa', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: masayoshi.shirakawa@merck.com.'}, {'ForeName': 'Yoshie', 'Initials': 'Y', 'LastName': 'Sugawara', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: yoshie.sugawara@merck.com.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Shuto', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: michiko.shutou@merck.com.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Sawata', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: miyuki.sawata@merck.com.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'MSD K.K., 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, 102-8667, Japan. Electronic address: yoshiyuki.tanaka@merck.com.'}]","Papillomavirus research (Amsterdam, Netherlands)",['10.1016/j.pvr.2020.100205']
3010,32827953,The strap intermuscular approach can significantly increase the exposure rate of the external branch of the superior laryngeal nerve during thyroid surgery.,"BACKGROUND


Avoiding injury to the external branch of the superior laryngeal nerve (EBSLN) is a major challenge during thyroid surgery. EBSLN injury can have an impact on the quality of life of patients. The aim of this study was to introduce the strap intermuscular approach, to dissect the EBSLN with two different approaches in thyroid surgery, to compare the differences between these two approaches, and to describe a way for surgeons to treat the upper thyroid gland to find the EBSLN.
METHODS


A prospective study of hemithyroidectomy was performed. In total, 104 patients were included and randomly divided into two groups: one group used the traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach. We described the surgical procedure for the strap intermuscular approach and compared the differences in the rates of EBSLN exposure, injury, and classification to illustrate the advantages of the intermuscular approach in thyroid surgery.
RESULTS


The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630). The exposure rate of EBSLNs classified as type 1 was higher in the strap intermuscular approach than in the traditional approach (30.77% vs. 13.46%, p = 0.033), with an OR and 95% CI of 0.350 (0.130-0.942).
CONCLUSIONS


The exposure rate of the EBSLN was significantly higher with the strap intermuscular approach method than with the traditional approach during thyroid surgery. This approach allows for better identification of the EBSLN during thyroidectomy.",2020,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).",['104 patients'],"['traditional approach to expose and protect the EBSLN, and the other group used the strap intermuscular approach', 'hemithyroidectomy']",['exposure rate of the EBSLN'],"[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0183631', 'cui_str': 'Strap'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}]","[{'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C1253959', 'cui_str': 'Branch of'}, {'cui': 'C0205814', 'cui_str': 'Structure of superior laryngeal nerve'}]",104.0,0.0387604,"The exposure rate of the EBSLN was higher with the strap intermuscular approach than with the traditional approach (96.15% vs. 76.92%, p = 0.01), with an odds ratio (OR) and 95% confidence interval (CI) of 0.133 (0.028-0.630).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Hu', 'Initials': 'H', 'LastName': 'Hei', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Songtao', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chuang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Gong', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Runfang', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Jianwu', 'Initials': 'J', 'LastName': 'Qin', 'Affiliation': 'Department of Thyroid and Neck, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China. Electronic address: qinjianwu_62@163.com.'}]",Surgical oncology,['10.1016/j.suronc.2020.08.004']
3011,32827729,Canakinumab Lacks Efficacy in Treating Adult Patients with Moderate to Severe Chronic Spontaneous Urticaria in a Phase II Randomized Double-blind Placebo-controlled Single Centre Study.,"BACKGROUND


Chronic spontaneous urticaria (CSU) is a common disease with a significant proportion of patients that do not respond to standard therapy with antihistamines and optionally corticosteroids/immunosuppressants.
OBJECTIVE


The IL-1β antagonist canakinumab is effective in cryopyrin associated periodic syndromes (CAPS) associated with urticarial symptoms and urticarial vasculitis, so it was suspected that it could also be effective in patients with CSU.
METHODS


The effect of canakinumab was investigated in 20 patients with moderate to severe CSU in a 1:1 randomization to either canakinumab or placebo in a double-blind single-dose crossover design. The verum group received 150 mg canakinumab subcutaneously once at baseline. Patients who had received placebo were able to switch to canakinumab at week 4 if they did not improve. Primary endpoint was clinical UAS7 improvement at week 4 compared to baseline. Secondary endpoints were the clinical UAS7 improvement at week 8 and the clinical improvement measured by the physician score and DLQI at week 1, 2, 4, and 8.
RESULTS


At week 4 two patients with canakinumab and three with placebo met the primary endpoint so that canakinumab failed the significant superiority to the placebo (p=1.0). An inclusion of the patients who switched to canakinumab after four weeks did not alter the result. There was also no significant difference between the verum and placebo groups for all secondary endpoints. The therapy was well tolerated, and mild AEs were equally distributed between verum and placebo.
CONCLUSION


Due to this clinical trial with 20 patients, it must be assumed that canakinumab has no effect on lesions of CSU. In conclusion, this suggests that IL1β may not play a crucial role in pathology of CSU patients, unlike e.g. in hereditary fevers or urticarial vasculitis, where targeting IL 1 is a main treatment option. However, the good tolerability of canakinumab could be confirmed.",2020,There was also no significant difference between the verum and placebo groups for all secondary endpoints.,"['Adult Patients with Moderate to Severe Chronic Spontaneous Urticaria', '20 patients', '20 patients with moderate to severe CSU in a 1:1 randomization to either', 'Chronic spontaneous urticaria (CSU', 'patients with CSU']","['canakinumab', 'Placebo', 'canakinumab or placebo', 'placebo']","['clinical UAS7 improvement at week 8 and the clinical improvement measured by the physician score and DLQI', 'tolerated, and mild AEs', 'clinical UAS7 improvement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C2718773', 'cui_str': 'canakinumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}]",20.0,0.409359,There was also no significant difference between the verum and placebo groups for all secondary endpoints.,"[{'ForeName': 'Julia-Tatjana', 'Initials': 'JT', 'LastName': 'Maul', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Switzerland. Electronic address: julia-tatjana.maul@usz.ch.'}, {'ForeName': 'Meike', 'Initials': 'M', 'LastName': 'Distler', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Switzerland; Christine Kühne Center for Allergy Research and Education CK-CARE Davos, Switzerland. Electronic address: julia-tatjana.maul@usz.ch.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Kolios', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Switzerland; Department of Immunology, University Hospital Zurich, Switzerland.'}, {'ForeName': 'Lara Valeska', 'Initials': 'LV', 'LastName': 'Maul', 'Affiliation': 'Department of Dermatology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Guillet', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Graf', 'Affiliation': 'Graf Biostatistics, Zürich.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Imhof', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Switzerland.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Lang', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Switzerland.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Navarini', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Switzerland; Department of Dermatology, University Hospital Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Schmid-Grendelmeier', 'Affiliation': 'Department of Dermatology, University Hospital Zurich, Switzerland; Christine Kühne Center for Allergy Research and Education CK-CARE Davos, Switzerland.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.07.058']
3012,32827752,"Comparison of efficacy and safety of empagliflozin vs linagliptin added to premixed insulin in patients with uncontrolled type 2 diabetes: a randomized, open-label study.","AIMS


Sodium-glucose cotransporter-2 (SGLT2) inhibitors and dipeptidyl peptidase (DPP)-4 inhibitors added to insulin regimens in patients with type 2 diabetes mellitus (T2DM) can improve glycaemic control. This study compared the efficacy and safety of empagliflozin and linagliptin added to premixed insulin therapy in patients with poorly controlled T2DM.
METHODS


In this 24-week, open-label, parallel-design randomized controlled trial, patients with poorly controlled T2DM despite a premixed insulin regimen were randomized to receive 5mg of linagliptin (n=53) or 25mg of empagliflozin (n=53) for 24 weeks.
RESULTS


At week 24, changes in glycated haemoglobin (HbA1c) from baseline were -0.06±0.17% and -1.01±0.16% in the linagliptin and empagliflozin groups, respectively, and the mean treatment HbA1c difference was -0.88% (95% CI: -1.33, -0.43). At week 24, the empagliflozin group showed significant reductions, compared with the linagliptin group, in fasting plasma glucose (P<0.001), body weight (P<0.001), systolic blood pressure (P=0.003) and total daily insulin dose (P=0.042). Hypoglycaemia was reported to be slightly, and not significantly, higher in the empagliflozin group vs linagliptin group (30.2% vs 22.6%, respectively; P=0.51). Similar percentages of patients (1.9%) had urinary tract infections in the two groups.
CONCLUSION


In Asian patients with inadequately controlled T2DM while taking premixed insulin, the addition of empagliflozin for 24 weeks provided better glycaemic control and greater reductions in body weight and systolic blood pressure than the addition of linagliptin.",2020,"At week 24, the empagliflozin group showed significant reductions, compared with the linagliptin group, in fasting plasma glucose (P<0.001), body weight (P<0.001), systolic blood pressure (P=0.003) and total daily insulin dose (P=0.042).","['patients with poorly controlled T2DM', 'patients with uncontrolled type 2 diabetes', 'patients with type 2 diabetes mellitus (T2DM', 'Asian patients with inadequately controlled T2DM while taking', 'patients with poorly controlled T2DM despite a premixed insulin regimen']","['DPP)-4 inhibitors added to insulin regimens', 'empagliflozin and linagliptin', 'empagliflozin', 'premixed insulin therapy', 'empagliflozin vs linagliptin', 'premixed insulin', 'Sodium-glucose cotransporter-2 (SGLT2) inhibitors and dipeptidyl peptidase ', 'linagliptin']","['urinary tract infections', 'total daily insulin dose', 'glycated haemoglobin (HbA1c', 'body weight', 'efficacy and safety', 'body weight and systolic blood pressure', 'systolic blood pressure', 'fasting plasma glucose', 'Hypoglycaemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0012515', 'cui_str': 'Dipeptidylpeptide hydrolase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}]","[{'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",,0.108803,"At week 24, the empagliflozin group showed significant reductions, compared with the linagliptin group, in fasting plasma glucose (P<0.001), body weight (P<0.001), systolic blood pressure (P=0.003) and total daily insulin dose (P=0.042).","[{'ForeName': 'Sung-Chen', 'Initials': 'SC', 'LastName': 'Liu', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, New Taipei City, Taiwan.'}, {'ForeName': 'Chun-Chuan', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, New Taipei City, Taiwan.'}, {'ForeName': 'Shih-Ming', 'Initials': 'SM', 'LastName': 'Chuang', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, MacKay Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.'}, {'ForeName': 'Fang-Ju', 'Initials': 'FJ', 'LastName': 'Sun', 'Affiliation': 'MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan; Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; Institute of Biomedical Informatics, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yi-Hong', 'Initials': 'YH', 'LastName': 'Zeng', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, New Taipei City, Taiwan; Institute of Public Health, National Yang Ming University, Taipei, Taiwan. Electronic address: starrydouchain@gmail.com.'}]",Diabetes & metabolism,['10.1016/j.diabet.2020.08.001']
3013,31351345,Three Lidcombe program clinic visit options: a phase II trial.,"PURPOSE


Weekly clinic visits are recommended in the Lidcombe Program Treatment Guide (Packman et al., 2015). That specification is based on traditional speech-language pathology practices rather than empirical research, and two studies have suggested that such a format does not always occur in clinical communities. This research was conducted to determine the relative efficacy of different Lidcombe Program models of clinic visits.
METHOD


Thirty-one children were randomized to three different service delivery models: twice-weekly, weekly and fortnightly (once every two weeks) clinic visits. All children were treated with the Lidcombe Program following manualised procedures. Measures of percentage syllables stuttered were obtained from beyond clinic audio recordings pre- and post-randomization.
RESULTS


Results showed that the twice-weekly and fortnightly treatment formats were not suitable for all families. However, the fortnightly outcomes at 9 months post-randomization were comparable with those attained during weekly clinic visits.
CONCLUSIONS


These results justify further, large-scale clinical trialling to compare weekly Lidcombe Program clinic visits with schedules involving less frequent clinic visits.",2019,"METHOD


Thirty-one children were randomized to three different service delivery models: twice-weekly, weekly and fortnightly (once every two weeks) clinic visits.",['Thirty-one children'],['Lidcombe Program'],[],"[{'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}]",[],31.0,0.011725,"METHOD


Thirty-one children were randomized to three different service delivery models: twice-weekly, weekly and fortnightly (once every two weeks) clinic visits.","[{'ForeName': 'Sarita', 'Initials': 'S', 'LastName': 'Koushik', 'Affiliation': 'University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hewat', 'Affiliation': 'University of Newcastle, Newcastle, Australia. Electronic address: Sally.Hewat@newcastle.edu.au.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Onslow', 'Affiliation': 'University of Technology Sydney, Australia.'}, {'ForeName': 'Rosalee', 'Initials': 'R', 'LastName': 'Shenker', 'Affiliation': 'Montreal Fluency Centre, Montreal, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Bond University, Brisbane, Australia.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': ""O'Brian"", 'Affiliation': 'University of Technology Sydney, Australia.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Packman', 'Affiliation': 'University of Technology Sydney, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Menzies', 'Affiliation': 'University of Technology Sydney, Australia.'}, {'ForeName': 'Elizabth', 'Initials': 'E', 'LastName': 'Harrison', 'Affiliation': 'Macquarie University, Sydney, Australia.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Wilson', 'Affiliation': 'Charles Sturt University, Albury, Australia.'}]",Journal of communication disorders,['10.1016/j.jcomdis.2019.105919']
3014,31081734,Standardising intraoperative irrigation with 0.05% chlorhexidine gluconate in caesarean delivery to reduce surgical site infections: A single institution experience.,"Background


Surgical site infection is a significant cause of morbidity and mortality following caesarean delivery.
Objective


To determine whether standardising intraoperative irrigation with 0.05% chlorhexidine gluconate during caesarean delivery could decrease infection rates.
Methods


This was a process improvement project involving 742 women, 343 of whom received low-pressured 0.05% chlorhexidine gluconate irrigation during caesarean delivery over a one-year period. Infection rates were compared with a standard-of-care control group (399 women) undergoing caesarean delivery the preceding year.
Results


The treatment group infection rate met the study goal by achieving a lower infection rate than the control group, though this was not statistically significant. A significant interaction effect between irrigation with 0.05% chlorhexidine gluconate and antibiotic administration time existed, such that infection occurrence in the treatment group was not dependent on antibiotic timing, as opposed to the control group infection occurrence, which was dependent on antibiotic timing.
Conclusion


Intraoperative irrigation with 0.05% chlorhexidine gluconate during caesarean delivery did not statistically significantly reduce the rate of infections. It did render the impact of antibiotic administration timing irrelevant in prevention of surgical site infection. This suggests a role for 0.05% chlorhexidine gluconate irrigation in mitigating infection risk whether antibiotic prophylaxis timing is suboptimal or ideal.",2020,"A significant interaction effect between irrigation with 0.05% chlorhexidine gluconate and antibiotic administration time existed, such that infection occurrence in the treatment group was not dependent on antibiotic timing, as opposed to the control group infection occurrence, which was dependent on antibiotic timing.
","['742 women, 343 of whom received low-pressured 0.05']","['chlorhexidine gluconate irrigation', 'chlorhexidine gluconate']","['infection rate', 'Infection rates', 'infection rates', 'surgical site infections', 'infection occurrence', 'rate of infections']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4517411', 'cui_str': '0.05'}]","[{'cui': 'C0055361', 'cui_str': 'chlorhexidine gluconate'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",742.0,,"A significant interaction effect between irrigation with 0.05% chlorhexidine gluconate and antibiotic administration time existed, such that infection occurrence in the treatment group was not dependent on antibiotic timing, as opposed to the control group infection occurrence, which was dependent on antibiotic timing.
","[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Mangold', 'Affiliation': ""Neonatal Services, Christus Santa Rosa Hospital-Westover Hills Women's Services Unit, San Antonio, USA.""}, {'ForeName': 'Erin Kinzel', 'Initials': 'EK', 'LastName': 'Hamilton', 'Affiliation': 'Louisville, USA.'}, {'ForeName': 'Helen Boehm', 'Initials': 'HB', 'LastName': 'Johnson', 'Affiliation': 'Vero Beach, USA.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Perez', 'Affiliation': ""Department of Obstetrics and Gynecology, Christus Santa Rosa Hospital-Westover Hills Women's Services Unit, San Antonio, USA.""}]",Journal of perioperative practice,['10.1177/1750458919850727']
3015,31537171,Inattention in misophonia: Difficulties achieving and maintaining alertness.,"Introduction : Misophonia is marked by abnormal negative reactions to specific and idiosyncratic sounds. Despite unclear etiology and diagnostic conceptualization, neuropsychology may be able to help characterize the syndrome. In the current study, we administered the Attention Network Test (ANT) under symptom provocation conditions, as well as secondary measures of concept formation, perseveration, processing speed, and frustration tolerance. We assessed treatment seeking individuals with misophonia and non-clinical controls. We hypothesized higher alerting, orienting, and conflict effects on the ANT suggesting overall poorer performance for the misophonia group. Methods : The sample consisted of symptomatic individuals recruited from a randomized treatment trial prior to the mandatory waitlist ( n  = 11) and age, gender matched controls ( n  = 11). Symptomatic individuals were screened with the Misophonia Questionnaire, as well as a number of additional self-report and diagnostic measures. Results : Robust Bayesian estimation in multi-level models suggested worse alerting attention for symptomatic individuals, β Median  = 2.766, β SD  = 1.253, 95%  CI  [0.322, 5.2876], Bayes factor = 31.41. There were no effects respective to block (i.e., blocks before versus during and after symptom provocation) or interaction effects. There were also no effects particular to executive functioning measures but some evidence this domain should be further explored (e.g., ANT conflict effects, perseveration, and serial math accuracy). Conclusions : We propose that symptom provocation alone does not explain the observed group difference in alerting attention, which could reflect a long-standing neuropsychological weakness. Future studies should attempt to characterize misophonia with more comprehensive neuropsychological batteries and larger samples.",2020,"Robust Bayesian estimation in multi-level models suggested worse alerting attention for symptomatic individuals, β Median  = 2.766, β SD  = 1.253, 95%  CI  [0.322, 5.2876], Bayes factor = 31.41.",['seeking individuals with misophonia and non-clinical controls'],['mandatory waitlist'],"['concept formation, perseveration, processing speed, and frustration tolerance']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4324623', 'cui_str': 'Misophonia'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0009636', 'cui_str': 'Concept Formation'}, {'cui': 'C0233651', 'cui_str': 'Perseveration (finding)'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0016770', 'cui_str': 'Frustration'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}]",,0.0616659,"Robust Bayesian estimation in multi-level models suggested worse alerting attention for symptomatic individuals, β Median  = 2.766, β SD  = 1.253, 95%  CI  [0.322, 5.2876], Bayes factor = 31.41.","[{'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Frank', 'Affiliation': 'Department of Psychology, Fordham University, New York, NY, USA.'}, {'ForeName': 'Meaghan', 'Initials': 'M', 'LastName': 'Roszyk', 'Affiliation': 'Department of Psychology, Fordham University, New York, NY, USA.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Hurley', 'Affiliation': 'Department of Psychology, Fordham University, New York, NY, USA.'}, {'ForeName': 'Loreta', 'Initials': 'L', 'LastName': 'Drejaj', 'Affiliation': 'Department of Psychology, Fordham University, New York, NY, USA.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'McKay', 'Affiliation': 'Department of Psychology, Fordham University, New York, NY, USA.'}]",Journal of clinical and experimental neuropsychology,['10.1080/13803395.2019.1666801']
3016,31125735,Insights for Management of Ground-Glass Opacities From the National Lung Screening Trial.,"BACKGROUND


In the National Lung Screening Trial (NLST), screen-detected cancers that would not have been identified by the Lung Computed Tomographic Screening Reporting and Data System (Lung-RADS) nodule management guidelines were frequently ground-glass opacities (GGOs). Lung-RADS suggests that GGOs with diameter less than 20 mm return for annual screening, and GGOs greater than or equal to 20 mm receive 6-month follow-up. We examined whether this 20-mm threshold gives consistent management of GGOs compared with solid nodules.
METHODS


First, we calculated diameter-specific malignancy probabilities for GGOs and solid nodules in the NLST. Using the solid-nodule malignancy risks as benchmarks, we suggested risk-based management categories for GGOs based on their probability of malignancy. Second, we compared lung-cancer mortality between GGOs and solid nodules in the same risk-based category.
RESULTS


Using the Lung-RADS v1.0 classifications, malignancy probability is higher for GGOs than solid nodules within the same category. A risk-based classification of GGOs would assign annual screening for GGOs 4 to 5 mm (0.4% malignancy risk); 6-month follow-up for GGOs 6 to 7 mm (1.1%), 8 to 14 mm (3.0%), and 15 to 19 mm (5.2%); and 3-month follow-up for greater than or equal to 20 mm (10.9%). This reclassification would have assigned similarly fatal cancers to 3-month follow-up (hazard ratio = 2.0 for lung-cancer death in GGOs versus solid-nodule cancers, 95% confidence interval: 0.4-8.7), but for 6-month follow-up, mortality was lower in GGO cancers (hazard ratio = 0.18, 95% confidence interval: 0.05-0.67).
CONCLUSIONS


If Lung-RADS categories for GGOs were based on malignancy probability, then 6- to 19-mm GGOs would receive 6-month follow-up and greater than or equal to 20-mm GGOs would receive 3-month follow-up. Such risk-based management for GGOs could improve the sensitivity of Lung-RADS, especially for large GGO cancers. However, small GGO cancers were less aggressive than their solid-nodule counterparts.",2019,"Such risk-based management for GGOs could improve the sensitivity of Lung-RADS, especially for large GGO cancers.",[],[],['lung-cancer mortality'],[],[],"[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0381368,"Such risk-based management for GGOs could improve the sensitivity of Lung-RADS, especially for large GGO cancers.","[{'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Robbins', 'Affiliation': 'International Agency for Research on Cancer, Lyon, France. Electronic address: RobbinsH@iarc.fr.'}, {'ForeName': 'Hormuzd A', 'Initials': 'HA', 'LastName': 'Katki', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Li C', 'Initials': 'LC', 'LastName': 'Cheung', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Landy', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland.'}, {'ForeName': 'Christine D', 'Initials': 'CD', 'LastName': 'Berg', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, Rockville, Maryland.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.05.012']
3017,31443886,The impact of drug court participation on mortality: 15-year outcomes from a randomized controlled trial.,"AIM


To test the effects of drug court participation on long-term mortality risk.
METHODS


During 1997-98, 235 individuals charged with a non-violent offense were randomly assigned to Baltimore City Drug Treatment Court (BCDTC) or traditional adjudication. Heroin was the predominant substance of choice among the sample. Participant mortality was observed for 15 years following randomization.
RESULTS


Over 20% of participants died during the study, at an average age of 46.6 years, and 64.4% of deaths were substance-use related. Survival analyses estimated that neither mortality from any cause nor from substance use-related causes significantly differed between BCDTC and traditional adjudication.
CONCLUSIONS


Frequent and premature death among the sample indicates that this is a high-risk population in need of effective substance use treatment. Roughly half of drug treatment courts are now estimated to offer medication assisted treatment (MAT), which is currently the most effective treatment for opioid use disorders. In this study of BCDTC implemented over 15 years ago, only 7% of participants received MAT, which may explain the lack of program impact on mortality. Historical barriers to providing MAT in drug court settings include access, concerns about diversion, negative attitudes, blanket prohibitions, and stigma. Drug treatment courts should implement best practice standards for substance use treatment and overdose prevention, including increased access to MAT and naloxone, and training to reduce stigmatizing language and practice.",2019,"Survival analyses estimated that neither mortality from any cause nor from substance use-related causes significantly differed between BCDTC and traditional adjudication.
","['During 1997-98, 235 individuals charged with a non-violent offense']","['Baltimore City Drug Treatment Court (BCDTC) or traditional adjudication', 'Heroin']","['mortality', 'Participant mortality']","[{'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0242151', 'cui_str': 'Violent'}]","[{'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}]",235.0,0.0492535,"Survival analyses estimated that neither mortality from any cause nor from substance use-related causes significantly differed between BCDTC and traditional adjudication.
","[{'ForeName': 'Brook W', 'Initials': 'BW', 'LastName': 'Kearley', 'Affiliation': 'University of Maryland School of Social Work, 525 West Redwood Street, Baltimore, MD 21201, USA. Electronic address: brook.kearley@ssw.umaryland.edu.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Cosgrove', 'Affiliation': 'University of Maryland School of Social Work, 525 West Redwood Street, Baltimore, MD 21201, USA. Electronic address: jcosgrove@ssw.umaryland.edu.'}, {'ForeName': 'Alexandra S', 'Initials': 'AS', 'LastName': 'Wimberly', 'Affiliation': 'University of Maryland School of Social Work, 525 West Redwood Street, Baltimore, MD 21201, USA. Electronic address: awimberly@ssw.umaryland.edu.'}, {'ForeName': 'Denise C', 'Initials': 'DC', 'LastName': 'Gottfredson', 'Affiliation': 'University of Maryland, Department of Criminology and Criminal Justice, 2220 Samuel J. LeFrak Hall, 7251 Preinkert Drive, College Park, MD 20742, USA. Electronic address: gott@umd.edu.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.07.004']
3018,30726984,"Can Removing Tar Information From Cigarette Packages Reduce Smokers' Misconceptions About Low-Tar Cigarettes? An Experiment From One of the World's Lowest Tar Yield Markets, South Korea.","INTRODUCTION


Despite regulations that forbid cigarette packages from displaying messages such as ""mild,"" ""low-tar,"" and ""light,"" many smokers still have misperceptions about ""light"" or ""low-tar"" cigarettes. One reason may be that tar amount displays continue to be permitted. This study examines whether removing tar delivery information from packaging reduces consumer misperceptions about ""low-tar"" cigarettes.
METHODS


An online experiment was conducted in South Korea among 531 smokers who were randomly assigned to one of two conditions: with and without tar information on cigarette packages. Participants evaluated which type of cigarette was mildest, least harmful, easiest for nonsmokers to start smoking, and easiest for smokers to quit.
RESULTS


Ten out of 12 chi-square tests showed that people judged the lowest reported tar delivery cigarette to be the mildest (p < .01), least harmful (p < .05), easiest to start (p < .05), and easiest to quit (p < .05)-less so in the ""no-tar"" condition than the ""tar"" condition. A higher level of misbeliefs about supposed low-tar cigarettes were found in the ""tar"" condition compared to the ""no-tar"" condition for all three brands (t = 5.85, 4.07, 3.82, respectively, p < .001). Regression analyses showed that the ""no-tar"" condition negatively predicted the level of misbeliefs after controlling for demographic and smoking-related variables (B [SE] = -.72 (.12), -.50 (.12), -.48 (.13), respectively, p < .001).
CONCLUSIONS


Banning reported tar deliveries from cigarette packages is likely to reduce smokers' misconceptions about ""low-tar"" cigarettes. When reported tar deliveries are absent, smokers have inconsistent judgments about differently packaged cigarettes.
IMPLICATIONS


When cigarette packages depict lower reported tar number deliveries, participants erroneously perceive them to be less harmful than packages displaying higher tar numbers. These misperceptions of harm may prompt smokers who might otherwise attempt to quit smoking to instead consume cigarettes with lower tar deliveries due to the mistaken belief that they will reduce their risk.",2020,"A higher level of misbeliefs about supposed low-tar cigarettes were found in the ""tar"" condition compared to the ""no tar"" condition for all three brands (t = 5.85, 4.07, 3.82, respectively, p < .001).",['South Korea among 531 smokers'],[],['delivery cigarette'],"[{'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]",[],"[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]",531.0,0.0139176,"A higher level of misbeliefs about supposed low-tar cigarettes were found in the ""tar"" condition compared to the ""no tar"" condition for all three brands (t = 5.85, 4.07, 3.82, respectively, p < .001).","[{'ForeName': 'Hye-Jin', 'Initials': 'HJ', 'LastName': 'Paek', 'Affiliation': 'Department of Advertising and Public Relations, Hanyang University, Ansan, South Korea.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Dewhirst', 'Affiliation': 'Department of Marketing and Consumer Studies, University of Guelph, Guelph, Ontario, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hove', 'Affiliation': 'Department of Advertising and Public Relations, Hanyang University, Ansan, South Korea.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz016']
3019,31647695,Assessing an ASCO Decision Aid for Improving the Accuracy and Attribution of Serious Adverse Event Reporting From Investigators to Sponsors.,"PURPOSE


Investigators often send reports to sponsors that incorrectly categorize adverse event (AE)s as serious or attribute AEs to investigational drugs. Such errors can contribute to high volumes of uninformative investigational new drug safety reports that sponsors submit to the US Food and Drug Administration and participating investigators, which strain resources and impede the detection of valid safety signals. To improve the quality of serious AE (SAE) reporting by physician-investigators and research staff, ASCO developed and tested a Decision Aid.
METHODS


A preliminary study with crossover design was conducted in a convenience sample. Physician-investigators and research staff were randomly assigned to receive case studies. Case studies were assessed for seriousness and attribution, first unassisted and then with the Decision Aid. Participants completed a feedback survey about the Decision Aid. Effectiveness of reporting and attribution are reported as odds ratios (ORs) with 95% CI. Power to detect associations was limited because of a small sample size.
RESULTS


The Decision Aid did not significantly affect accuracy of determining seriousness (OR, 0.87; 95% CI, 0.31 to 2.46), but it did significantly increase accuracy of attributing an SAE to a drug (OR, 3.60; 95% CI, 1.15 to 11.4). Most of the 29 participants reported that the Decision Aid was helpful (93%) and improved decision-making time (69%) and confidence in reporting (83%), and that they would use the Decision Aid in practice (83%).
CONCLUSION


The Decision Aid shows promise as a method to improve the quality of SAE attribution, which may improve the detection of valid safety signals and reduce the administrative burden of uninformative investigational new drug safety reports. Study of the Decision Aid in a larger sample with analysis stratified by participant role and SAE reporting experience would further assess the tool's impact.",2019,"The Decision Aid did not significantly affect accuracy of determining seriousness (OR, 0.87; 95% CI, 0.31 to 2.46), but it did significantly increase accuracy of attributing an SAE to a drug (OR, 3.60; 95% CI, 1.15 to 11.4).",[],[],"['quality of serious AE (SAE', 'decision-making time']",[],[],"[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0601982,"The Decision Aid did not significantly affect accuracy of determining seriousness (OR, 0.87; 95% CI, 0.31 to 2.46), but it did significantly increase accuracy of attributing an SAE to a drug (OR, 3.60; 95% CI, 1.15 to 11.4).","[{'ForeName': 'Kathryn F', 'Initials': 'KF', 'LastName': 'Mileham', 'Affiliation': 'Levine Cancer Institute, Atrium Health Charlotte NC.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Schenkel', 'Affiliation': 'American Society of Clinical Oncology, Alexandria, VA.'}, {'ForeName': 'Meredith K', 'Initials': 'MK', 'LastName': 'Chuk', 'Affiliation': 'US Food and Drug Administration, Silver Spring, MD.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Buchmeier', 'Affiliation': 'Sarah Cannon Cancer Center, Nashville, TN.'}, {'ForeName': 'Raymond P', 'Initials': 'RP', 'LastName': 'Perez', 'Affiliation': 'Bristol-Myers Squibb, New York, NY.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Hurley', 'Affiliation': 'American Society of Clinical Oncology, Alexandria, VA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Levit', 'Affiliation': 'American Society of Clinical Oncology, Alexandria, VA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Garrett-Mayer', 'Affiliation': 'American Society of Clinical Oncology, Alexandria, VA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Davis', 'Affiliation': 'American Society of Clinical Oncology, Alexandria, VA.'}, {'ForeName': 'Suanna S', 'Initials': 'SS', 'LastName': 'Bruinooge', 'Affiliation': 'American Society of Clinical Oncology, Alexandria, VA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Vose', 'Affiliation': 'University of Nebraska Medical Center, Omaha, NE.'}]",Journal of oncology practice,['10.1200/JOP.19.00366']
3020,31738070,Comparing the validity of trait estimates from the multidimensional forced-choice format and the rating scale format.,"The multidimensional forced-choice (MFC) format has been proposed as an alternative to rating scales (RS) that may be less susceptible to response biases. The goal of this study was to compare the validity of trait estimates from the MFC and the RS format when using normative scoring for both formats. We focused on construct validity and criterion-related validity. In addition, we investigated test-retest reliability over a period of six months. Participants were randomly assigned the MFC (N = 593) or the RS (N = 622) version of the Big Five Triplets. In addition to self-ratings on the Big Five Triplets and other personality questionnaires and criteria, we also obtained other-ratings (N = 770) for the Big Five Triplets. The Big Five in the Big Five Triplets corresponded well with the Big Five in the Big Five Inventory except for agreeableness in the MFC version. The majority of the construct validity coefficients differed between the MFC and the RS version, whereas criterion-related validities were very similar. The self- and other-rated Big Five Triplets showed higher correlations in the MFC format than in the RS format. The reliability of trait estimates on the Big Five and test-retest reliabilities were lower for MFC compared to RS. For the MFC format to be able to replace the RS format, more research on how to obtain ideal constellations of items that are matched in their desirability is needed. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,The reliability of trait estimates on the Big Five and test-retest reliabilities were lower for MFC compared to RS.,[],['MFC'],[],[],[],[],2019.0,0.0437251,The reliability of trait estimates on the Big Five and test-retest reliabilities were lower for MFC compared to RS.,"[{'ForeName': 'Eunike', 'Initials': 'E', 'LastName': 'Wetzel', 'Affiliation': 'Department of Psychology, University of Konstanz.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Frick', 'Affiliation': 'Department of Psychology, University of Konstanz.'}]",Psychological assessment,['10.1037/pas0000781']
3021,31779535,The Green Light for Green Dot: A Qualitative Study of Factors Influencing Adoption of an Efficacious Violence Prevention Program in High School Settings.,"The purpose of this qualitative study was to investigate factors influencing the adoption of an effective bystander-based sexual violence prevention intervention. High schools participating in a cluster-randomized controlled trial that found significant declines in sexual violence over time and with full implementation were invited to adopt this program (Green Dot) at no cost. Three emergent themes arose from interviews with 10 intervention implementers. These findings have implications for researchers, practitioners, and high school administrators and may facilitate future program marketing efforts and the development and testing of strategies for targeted dissemination of this and other bystander programs for violence.",2020,The purpose of this qualitative study was to investigate factors influencing the adoption of an effective bystander-based sexual violence prevention intervention.,['High School Settings'],"['Green Light for Green Dot', 'bystander-based sexual violence prevention intervention']",['sexual violence'],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C1306567', 'cui_str': 'Green light (physical force)'}, {'cui': 'C0332583', 'cui_str': 'Green color (qualifier value)'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C3489576', 'cui_str': 'Sexual Violence'}]",,0.0177074,The purpose of this qualitative study was to investigate factors influencing the adoption of an effective bystander-based sexual violence prevention intervention.,"[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Davidov', 'Affiliation': 'West Virginia University, Morgantown, USA.'}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'NYU Winthrop Hospital, Mineola, USA.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Bush', 'Affiliation': 'University of Kentucky, Lexington, USA.'}, {'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Coker', 'Affiliation': 'University of Kentucky, Lexington, USA.'}]",Violence against women,['10.1177/1077801219886377']
3022,31883370,"Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infection: 12-Month Observational Data From the Randomized Phase III Trial, MODIFY II.","From Monoclonal Antibodies for C. difficile Therapy II, no participants (n = 0/69) with a sustained clinical cure through 12 weeks following bezlotoxumab infusion experienced recurrent Clostridioides difficile infection (rCDI) after 9 months (versus actoxumab + bezlotoxumab, n = 2/65; versus placebo, n = 1/34). Bezlotoxumab's efficacy appears to be due to prevention rather than delayed onset of rCDI. Clinical Trials Registration. NCT01513239.",2020,"From Monoclonal Antibodies for C. difficile Therapy II, no participants (n = 0/69) with a sustained clinical cure through 12 weeks following bezlotoxumab infusion experienced recurrent Clostridioides difficile infection (rCDI) after 9 months (versus actoxumab + bezlotoxumab, n = 2/65; versus placebo, n = 1/34).",[],"['bezlotoxumab', 'actoxumab + bezlotoxumab', 'placebo', 'Bezlotoxumab']",['recurrent Clostridioides difficile infection (rCDI'],[],"[{'cui': 'C4291320', 'cui_str': 'bezlotoxumab'}, {'cui': 'C4308583', 'cui_str': 'actoxumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",,0.0939758,"From Monoclonal Antibodies for C. difficile Therapy II, no participants (n = 0/69) with a sustained clinical cure through 12 weeks following bezlotoxumab infusion experienced recurrent Clostridioides difficile infection (rCDI) after 9 months (versus actoxumab + bezlotoxumab, n = 2/65; versus placebo, n = 1/34).","[{'ForeName': 'Ellie J C', 'Initials': 'EJC', 'LastName': 'Goldstein', 'Affiliation': 'R. M. Alden Research Laboratory, Santa Monica, California, USA.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Citron', 'Affiliation': 'R. M. Alden Research Laboratory, Santa Monica, California, USA.'}, {'ForeName': 'Dale N', 'Initials': 'DN', 'LastName': 'Gerding', 'Affiliation': 'Hines Veterans Affairs Hospital, Hines, Illinois, USA.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Wilcox', 'Affiliation': 'Leeds Teaching Hospitals and University of Leeds, Leeds, West Yorkshire, United Kingdom.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Gabryelski', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Pedley', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zeng', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Dorr', 'Affiliation': 'Merck & Co., Inc., Kenilworth, New Jersey, USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1151']
3023,31931509,The acute effects of nicotine on corticostriatal responses to distinct phases of reward processing.,"Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues. This anticipatory effect is selective as no clear evidence has emerged showing that nicotine acutely changes reward receipt reactivity. However, repeated rewarding experiences shift peak brain reactivity from hedonic reward outcome to the motivational anticipatory cue yielding more habitual cue-induced behavior. Given nicotine's influence on NAcc reactivity and connectivity, it is plausible that nicotine acutely induces this shift and alters NAcc functional connectivity during reward processing. To evaluate this currently untested hypothesis, a randomized crossover design was used in which healthy non-smokers were administered placebo and nicotine (2-mg lozenge). Brain activation to monetary reward anticipation and outcome was evaluated with functional magnetic resonance imaging. Relative to placebo, nicotine induced more NAcc reactivity to reward anticipation. Greater NAcc activation during anticipation was significantly associated with lower NAcc activation to outcome. During outcome, nicotine reduced NAcc functional connectivity with cortical regions including the anterior cingulate cortex, orbitofrontal cortex, and insula. These regions showed the same negative relationship between reward anticipation and outcome as noted in the NAcc. The current findings significantly improve our understanding of how nicotine changes corticostriatal circuit function and communication during distinct phases of reward processing and critically show that these alterations happen acutely following a single dose. The implications of this work explain nicotinic modulation of general reward function, which offer insights into the initial drive to smoke and the subsequent difficulty in cessation.",2020,Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues.,['healthy non-smokers'],"['nicotine', 'Nicotine', 'placebo and nicotine (2-mg lozenge', 'placebo, nicotine']","['anterior cingulate cortex, orbitofrontal cortex, and insula', 'Greater NAcc activation', 'habitual cue-induced behavior']","[{'cui': 'C4554605', 'cui_str': 'Nonsmokers'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0321595,Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues.,"[{'ForeName': 'Kainan S', 'Initials': 'KS', 'LastName': 'Wang', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Zegel', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Molokotos', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Lauren V', 'Initials': 'LV', 'LastName': 'Moran', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Olson', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Janes', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA. ajanes@mclean.harvard.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0611-5']
3024,31848625,"Commentary: Antibiotic or Silver Versus Standard Ventriculoperitoneal Shunts (BASICS): A Multicentre, Single-Blinded, Randomised Trial and Economic Evaluation.",,2020,,[],['Antibiotic or Silver Versus Standard Ventriculoperitoneal Shunts (BASICS'],[],[],"[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0037125', 'cui_str': 'Silver'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0175662', 'cui_str': 'Ventriculoperitoneal shunt device (physical object)'}]",[],,0.248317,,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Klimo', 'Affiliation': 'Department of Neurosurgery, The University of Tennessee Health Science Center, Memphis, Tennessee.'}, {'ForeName': 'Nickalus R', 'Initials': 'NR', 'LastName': 'Khan', 'Affiliation': 'Department of Neurosurgery, The University of Tennessee Health Science Center, Memphis, Tennessee.'}, {'ForeName': 'Luke G F', 'Initials': 'LGF', 'LastName': 'Smith', 'Affiliation': 'Department of Neurosurgery, The Ohio State University, Columbus, Ohio.'}]",Neurosurgery,['10.1093/neuros/nyz541']
3025,32195655,A Qualitative Study of Increased Pediatric Reutilization After a Postdischarge Home Nurse Visit.,"BACKGROUND


The Hospital to Home Outcomes (H2O) trial was a 2-arm, randomized controlled trial that assessed the effects of a nurse home visit after a pediatric hospital discharge. Children randomized to the intervention had higher 30-day postdischarge reutilization rates compared with those with standard discharge. We sought to understand perspectives on why postdischarge home nurse visits resulted in higher reutilization rates and to elicit suggestions on how to improve future interventions.
METHODS


We sought qualitative input using focus groups and interviews from stakeholder groups: parents, primary care physicians (PCP), hospital medicine physicians, and home care registered nurses (RNs). A multidisciplinary team coded and analyzed transcripts using an inductive, iterative approach.
RESULTS


Thirty-three parents participated in interviews. Three focus groups were completed with PCPs (n = 7), 2 with hospital medicine physicians (n = 12), and 2 with RNs (n = 10). Major themes in the explanation of increased reutilization included: appropriateness of patient reutilization; impact of red flags/warning sign instructions on family's reutilization decisions; hospital-affiliated RNs ""directing traffic"" back to hospital; and home visit RNs had a low threshold for escalating care. Major themes for improving design of the intervention included: need for improved postdischarge communication; individualizing home visits-one size does not fit all; and providing context and framing of red flags.
CONCLUSION


Stakeholders questioned whether hospital reutilization was appropriate and whether the intervention unintentionally directed patients back to the hospital. Future interventions could individualize the visit to specific needs or diagnoses, enhance postdischarge communication, and better connect patients and home nurses to primary care.",2020,Children randomized to the intervention had higher 30-day postdischarge reutilization rates compared with those with standard discharge.,"['Thirty-three parents participated in interviews', 'n = 7), 2 with hospital medicine physicians (n = 12), and 2 with RNs (n = 10', 'stakeholder groups: parents, primary care physicians (PCP), hospital medicine physicians, and home care registered nurses (RNs']",['PCPs'],['30-day postdischarge reutilization rates'],"[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C3658340', 'cui_str': 'Hospital Medicine'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse (occupation)'}]",[],"[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",33.0,0.0821655,Children randomized to the intervention had higher 30-day postdischarge reutilization rates compared with those with standard discharge.,"[{'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Riddle', 'Affiliation': ""Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Susan N', 'Initials': 'SN', 'LastName': 'Sherman', 'Affiliation': 'SNS Research, Cincinnati, Ohio.'}, {'ForeName': 'Margo J', 'Initials': 'MJ', 'LastName': 'Moore', 'Affiliation': ""Division of Patient Services, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Loechtenfeldt', 'Affiliation': ""Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Tubbs-Cooley', 'Affiliation': 'College of Nursing, Martha S. Pitzer Center for Women, Children and Youth, Columbus, Ohio.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Gold', 'Affiliation': ""Division of Patient Services, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Wade-Murphy', 'Affiliation': ""Division of Patient Services, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Andrew F', 'Initials': 'AF', 'LastName': 'Beck', 'Affiliation': ""Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Statile', 'Affiliation': ""Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Samir S', 'Initials': 'SS', 'LastName': 'Shah', 'Affiliation': ""Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Simmons', 'Affiliation': ""Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Auger', 'Affiliation': ""Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ""Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}]",Journal of hospital medicine,['10.12788/jhm.3370']
3026,32217953,Mifepristone Antagonization With Progesterone to Prevent Medical Abortion: A Randomized Controlled Trial.,,2020,,['Medical Abortion'],"['Mifepristone Antagonization', 'Progesterone']",[],"[{'cui': 'C3146283', 'cui_str': 'Medical abortion'}]","[{'cui': 'C0026088', 'cui_str': 'Mifepristone'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}]",[],,0.194373,,"[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Valley', 'Affiliation': 'St. Louis Park, Minnesota.'}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003781']
3027,31917621,"Thrombomodulin Alfa for Acute Exacerbation of Idiopathic Pulmonary Fibrosis. A Randomized, Double-Blind Placebo-controlled Trial.","Rationale:  Acute exacerbation during the course of idiopathic pulmonary fibrosis causes a poor prognosis. Coagulation abnormalities and endothelial damage are involved in its pathogenesis. Thrombomodulin alfa, a recombinant human soluble thrombomodulin, has anticoagulant and antiinflammatory effects. Several clinical studies have shown that thrombomodulin alfa may improve survival of acute exacerbation. Objectives:  To determine the efficacy and safety of thrombomodulin alfa compared with placebo in acute exacerbation of idiopathic pulmonary fibrosis. Methods:  This randomized, double-blind placebo-controlled phase 3 study conducted at 27 sites in Japan involved patients with an acute exacerbation of idiopathic pulmonary fibrosis. Subjects were randomized 1:1 to receive placebo or thrombomodulin alfa (380 U/kg/d for 14 d by intravenous drip infusion). All subjects were treated with high-dose corticosteroid therapy. The primary endpoint was the survival proportion on Day 90. Measurements and Main Results:  Of the 82 randomized subjects, 77 completed the study and were included in the full analysis set (thrombomodulin alfa,  n  = 40; placebo,  n  = 37). The survival proportions on Day 90 were 72.5% (29 of 40) in the thrombomodulin alfa group and 89.2% (33 of 37) in the placebo group, a difference of -16.7 percentage points (95% confidence interval, -33.8 to 0.4%;  P  = 0.0863). In the safety population ( n  = 80), bleeding adverse events occurred in the thrombomodulin alfa group (10 of 42; 23.8%) and the placebo group (4 of 38; 10.5%). Conclusions:  Thrombomodulin alfa did not improve the 90-day survival proportion. The present results suggest that the use of thrombomodulin alfa for the treatment of acute exacerbation of idiopathic pulmonary fibrosis not be recommended.Clinical trial registered with www.clinicaltrials.gov (NCT02739165).",2020,"The survival proportion on Day 90 was 72.5% (29/40) in the thrombomodulin alfa group and 89.2% (33/37) in the placebo group, a difference of -16.7 percentage points (95% CI, -33.8% to 0.4%, p=0.0863).","['Acute Exacerbation of Idiopathic Pulmonary Fibrosis', 'acute exacerbation of idiopathic pulmonary fibrosis', '27 sites in Japan involved patients with an acute exacerbation of idiopathic pulmonary fibrosis']","['Placebo', 'Thrombomodulin alfa', 'corticosteroid therapy', 'placebo', 'Thrombomodulin alfa, a recombinant human soluble thrombomodulin', 'thrombomodulin alfa', 'placebo or thrombomodulin alfa']","['survival proportion', '90-day survival proportion', 'survival proportion on Day 90', 'bleeding adverse events']","[{'cui': 'C2242482', 'cui_str': 'Exacerbation of idiopathic pulmonary fibrosis'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",77.0,0.706193,"The survival proportion on Day 90 was 72.5% (29/40) in the thrombomodulin alfa group and 89.2% (33/37) in the placebo group, a difference of -16.7 percentage points (95% CI, -33.8% to 0.4%, p=0.0863).","[{'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Kondoh', 'Affiliation': 'Department of Respiratory Medicine and Allergy, Tosei General Hospital, Aichi, Japan.'}, {'ForeName': 'Arata', 'Initials': 'A', 'LastName': 'Azuma', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Clincal Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Osaka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ogura', 'Affiliation': 'Division of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tsushima', 'Affiliation': 'Department of Pulmonary Medicine, School of Medicine, International University of Health and Welfare, Chiba, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Johkoh', 'Affiliation': 'Department of Radiology, Kansai Rosai Hospital, Hyogo, Japan.'}, {'ForeName': 'Kiminori', 'Initials': 'K', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Ichikado', 'Affiliation': 'Division of Respiratory Medicine, Saiseikai Kumamoto Hospital, Kumamoto, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Matsuzawa', 'Affiliation': 'Department of Respiratory Medicine, Toho University Medical Center-Sakura Hospital, Chiba, Japan.'}, {'ForeName': 'Takefumi', 'Initials': 'T', 'LastName': 'Saito', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization, Ibarakihigashi National Hospital, Ibaraki, Japan.'}, {'ForeName': 'Kazuma', 'Initials': 'K', 'LastName': 'Kishi', 'Affiliation': 'Department of Respiratory Medicine, Toho University Omori Medical Center, Tokyo, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Tomii', 'Affiliation': 'Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Hyogo, Japan.'}, {'ForeName': 'Noriho', 'Initials': 'N', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Aoshima', 'Affiliation': 'Department of Pulmonology, Kameda Medical Center, Chiba, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Araya', 'Affiliation': 'Division of Respiratory Diseases, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Shinyu', 'Initials': 'S', 'LastName': 'Izumi', 'Affiliation': 'Department of Respiratory Medicine, National Center for Global Health and Medicine, Tokyo, Japan.'}, {'ForeName': 'Machiko', 'Initials': 'M', 'LastName': 'Arita', 'Affiliation': 'Department of Respiratory Medicine, Kurashiki Central Hospital, Okayama, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Abe', 'Affiliation': 'Department of Respirology, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Yamauchi', 'Affiliation': 'Division of Pulmonary Medicine, Department of Medicine, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Shindoh', 'Affiliation': 'Department of Respiratory Medicine, Ogaki Municipal Hospital, Gifu, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Suda', 'Affiliation': 'Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine, Shizuoka, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Okamoto', 'Affiliation': 'Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Fukuoka, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Ebina', 'Affiliation': 'Department of Respiratory Medicine, Tohoku Medical and Pharmaceutical University, Miyagi, Japan.'}, {'ForeName': 'Yoshihito', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Department of Respiratory Medicine, Japan Railway Tokyo General Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Tohda', 'Affiliation': 'Department of Respiratory Medicine and Allergology, Faculty of Medicine, Kindai University, Osaka, Japan.'}, {'ForeName': 'Tetsuji', 'Initials': 'T', 'LastName': 'Kawamura', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Himeji Medical Center, Hyogo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Taguchi', 'Affiliation': 'Department of Respiratory Medicine, Tenri Hospital, Nara, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ishii', 'Affiliation': 'Department of Respiratory Medicine, Fukuoka University Hospital, Fukuoka, Japan.'}, {'ForeName': 'Naozumi', 'Initials': 'N', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Aichi, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Abe', 'Affiliation': 'Department of Respiratory Medicine, Tokyo Medical University Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Respiratory Medicine and Allergy, Tosei General Hospital, Aichi, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tagawa', 'Affiliation': 'Asahi-Kasei Pharma Corporation, Tokyo, Japan; and.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Bessho', 'Affiliation': 'Asahi-Kasei Pharma Corporation, Tokyo, Japan; and.'}, {'ForeName': 'Natsuki', 'Initials': 'N', 'LastName': 'Yamamori', 'Affiliation': 'Asahi-Kasei Pharma Corporation, Tokyo, Japan; and.'}, {'ForeName': 'Sakae', 'Initials': 'S', 'LastName': 'Homma', 'Affiliation': 'Department of Advanced and Integrated Interstitial Lung Diseases Research, School of Medicine, Toho University, Tokyo, Japan.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201909-1818OC']
3028,30374191,Opioid system modulation with buprenorphine/samidorphan combination for major depressive disorder: two randomized controlled studies.,"The endogenous opioid system is thought to play an important role in the regulation of mood. Buprenorphine/samidorphan (BUP/SAM) combination is an investigational opioid system modulator for adjunctive treatment of major depressive disorder (MDD). To confirm results from early studies, we report the efficacy and safety of BUP/SAM as adjunctive treatment in patients with MDD and an inadequate response to antidepressant therapy (ADT) in FORWARD-4 and FORWARD-5: two phase 3, randomized, double-blind, placebo-controlled studies that utilized the same sequential parallel-comparison design. Efficacy was measured using the Montgomery-Åsberg Depression Rating Scale (MADRS). FORWARD-5 achieved the primary endpoint and demonstrated that adjunctive BUP/SAM 2 mg/2 mg was superior to placebo (average difference change from baseline to week 3 through end of treatment [EOT] in MADRS-6 and -10 versus placebo: -1.5, P = 0.018; -1.9, P = 0.026, respectively). FORWARD-4 did not achieve the primary endpoint (change from baseline in MADRS-10 at week 5 versus placebo: -1.8, P = 0.109), although separate analyses showed significant treatment differences at other timepoints using traditional, regulatory-accepted endpoints such as reduction in MADRS-10 at EOT. The pooled analysis of the two studies demonstrated consistently greater reduction in MADRS-10 scores from baseline for BUP/SAM 2 mg/2 mg versus placebo at multiple timepoints including EOT and average change from baseline to week 3 through EOT (-1.8, P = 0.010; -1.8, P = 0.004, respectively). The overall effect size (Hedges' g) in the pooled analyses for MADRS-10 change from baseline to EOT was 0.22. Overall, BUP/SAM was generally well tolerated, with most adverse events (AEs) being mild or moderate in severity. The most common AEs, occurring in ≥5% of patients in the BUP/SAM 2 mg/2 mg treatment group, which was more frequently than the placebo group, included nausea, constipation, dizziness, vomiting, somnolence, fatigue, and sedation. There was minimal evidence of abuse, and no evidence of dependence or opioid withdrawal by AEs or objective measures. This report describes adjunctive BUP/SAM 2 mg/2 mg combination, a therapy with a novel opioidergic mechanism of action, as a potential new treatment option for patients with MDD who have an inadequate response to currently available ADT.",2020,,['major depressive disorder'],['buprenorphine/samidorphan combination'],[],"[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}]",[],,0.231079,,"[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (CTNI), Harvard Medical School, Boston, MA, USA. MFAVA@mgh.harvard.edu.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine and the Corporal Michael Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Ehrich', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Martin', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Memisoglu', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Nangia', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Arielle D', 'Initials': 'AD', 'LastName': 'Stanford', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0284-1']
3029,32093667,Topical povidone iodine inhibits bacterial growth in the oral cavity of patients on mechanical ventilation: a randomized controlled study.,"BACKGROUND


Topical 0.12% chlorhexidine has been used widely to prevent ventilator-associated pneumonia in patients undergoing mechanical ventilation. However, it is not approved for mucosal application in Japan. The aims of this study were to investigate if topical povidone iodine (i) inhibits bacterial growth and (ii) disrupts the balance of the oral microbiota.
METHODS


This randomized controlled clinical trial included 23 patients who underwent mechanical ventilation in the intensive care unit. The patients were divided randomly into two groups: the intervention group (n = 16) and the control group (n = 7). All patients received oral cleaning with 3% hydrogen peroxide, followed by irrigation with tap water. The patients in the intervention group received 10% povidone iodine applied topically to the oral cavity. The concentration of total bacteria in the oropharyngeal fluid were determined before, immediately after, 1 h, 2 h, and 3 h after oral care using the Rapid Oral Bacteria Quantification System, which is based on dielectrophoresis and impedance measurements. The number of streptococci, methicillin-resistant Staphylococcus aureus, Streptococcus pneumoniae, Pseudomonas aeruginosa, Porphyromonas gingivalis, and Candida albicans before, immediately after, 1 h, and 3 h after oral care were estimated based on real-time polymerase chain reaction data.
RESULTS


After irrigation of the oral cavity, the number of bacteria decreased, but increased again at 1 h after oral care in the control group; however, in the intervention group, the concentration of bacteria was significantly lower than that in the control group at 1 hour (p = 0.009), 2 h (p = 0.001), and 3 h (p = 0.001) after oral care. The growth of all bacterial species tested was inhibited in the intervention group at 3 h after oral care, suggesting that povidone iodine did not disturb the balance of the oral microbiota.
CONCLUSIONS


Topical application of povidone iodine after cleaning and irrigation of the oral cavity inhibited bacterial growth in the oropharyngeal fluid of patients on mechanical ventilation while not disrupting the balance of the oral microbiota.
TRIAL REGISTRATION


University Hospitals Medical Information Network Clinical Trials Registry (UMIN-CTR), UMIN000028307. Registered 1 September 2017.",2020,"After irrigation of the oral cavity, the number of bacteria decreased, but increased again at 1 h after oral care in the control group; however, in the intervention group, the concentration of bacteria was significantly lower than that in the control group at 1 hour (p = 0.009), 2 h (p = 0.001), and 3 h (p = 0.001) after oral care.","['patients undergoing mechanical ventilation', '23 patients who underwent mechanical ventilation in the intensive care unit', 'patients on mechanical ventilation']","['chlorhexidine', 'oral cleaning with 3% hydrogen peroxide, followed by irrigation with tap water', 'Topical povidone iodine', 'topical povidone iodine (i', 'povidone iodine']","['concentration of total bacteria', 'concentration of bacteria', 'number of bacteria', 'number of streptococci, methicillin-resistant Staphylococcus aureus, Streptococcus pneumoniae, Pseudomonas aeruginosa, Porphyromonas gingivalis, and Candida albicans']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C2919405', 'cui_str': 'Tap water (substance)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1265292', 'cui_str': 'MRSA'}, {'cui': 'C0038410', 'cui_str': 'Streptococcus pneumoniae'}, {'cui': 'C0033808', 'cui_str': 'Flavimonas'}, {'cui': 'C0206347', 'cui_str': 'Porphyromonas'}, {'cui': 'C0006837', 'cui_str': 'Candida albicans'}]",23.0,0.0420973,"After irrigation of the oral cavity, the number of bacteria decreased, but increased again at 1 h after oral care in the control group; however, in the intervention group, the concentration of bacteria was significantly lower than that in the control group at 1 hour (p = 0.009), 2 h (p = 0.001), and 3 h (p = 0.001) after oral care.","[{'ForeName': 'Shoma', 'Initials': 'S', 'LastName': 'Tsuda', 'Affiliation': 'Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8588, Japan.'}, {'ForeName': 'Sakiko', 'Initials': 'S', 'LastName': 'Soutome', 'Affiliation': 'Oral Care Center, Nagasaki University Hospital, 1-7-1 Sakamoto, Nagasaki, 852-8588, Japan. Sakiko@nagasaki-u.ac.jp.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Hayashida', 'Affiliation': 'Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8588, Japan.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Funahara', 'Affiliation': 'Kyushu Dental University School of Oral Health Sciences, 2-6-1 Manazuru, Kokurakitaku, Kitakyushu, 803-8580, Japan.'}, {'ForeName': 'Souichi', 'Initials': 'S', 'LastName': 'Yanamoto', 'Affiliation': 'Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8588, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Umeda', 'Affiliation': 'Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8588, Japan.'}]",BMC oral health,['10.1186/s12903-020-1043-7']
3030,31404033,"A DOUBLE-MASKED, RANDOMIZED, SHAM-CONTROLLED, SINGLE-CENTER STUDY WITH PHOTOBIOMODULATION FOR THE TREATMENT OF DRY AGE-RELATED MACULAR DEGENERATION.","PURPOSE


The LIGHTSITE I study investigated the efficacy and safety of photobiomodulation (PBM) treatment in subjects with dry age-related macular degeneration.
METHODS


Thirty subjects (46 eyes) were treated with the Valeda Light Delivery System, wherein subjects underwent two series of treatments (3× per week for 3-4 weeks) over 1 year. Outcome measures included best-corrected visual acuity, contrast sensitivity, microperimetry, central drusen volume and drusen thickness, and quality of life assessments.
RESULTS


Photobiomodulation-treated subjects showed a best-corrected visual acuity mean letter score gain of 4 letters immediately after each treatment series at Month 1 (M1) and Month 7 (M7). Approximately 50% of PBM-treated subjects showed improvement of ≥5 letters versus 13.6% in sham-treated subjects at M1. High responding subjects (≥5-letter improvement) in the PBM-treated group showed a gain of 8 letters after initial treatment (P < 0.01) and exhibited earlier stages of age-related macular degeneration disease. Statistically significant improvements in contrast sensitivity, central drusen volume, central drusen thickness, and quality of life were observed (P < 0.05). No device-related adverse events were reported.
CONCLUSION


Photobiomodulation treatment statistically improved clinical and anatomical outcomes with more robust benefits observed in subjects with earlier stages of dry age-related macular degeneration. Repeated PBM treatments are necessary to maintain benefits. These pilot findings support previous reports and suggest the utility of PBM as a safe and effective therapy in subjects with dry age-related macular degeneration.",2020,"Statistically significant improvements in contrast sensitivity, central drusen volume, central drusen thickness, and quality of life were observed (P < 0.05).","['subjects with earlier stages of dry age-related macular degeneration', 'Thirty subjects (46 eyes', 'subjects with dry age-related macular degeneration']","['PBM', 'Valeda Light Delivery System', 'photobiomodulation (PBM']","['best-corrected visual acuity mean letter score gain', 'contrast sensitivity, central drusen volume, central drusen thickness, and quality of life', 'best-corrected visual acuity, contrast sensitivity, microperimetry, central drusen volume and drusen thickness, and quality of life assessments', 'improvement of ≥5 letters']","[{'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C3888461', 'cui_str': 'Dry age-related macular degeneration'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0015392', 'cui_str': 'Eye'}]","[{'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0449914', 'cui_str': 'Delivery system (attribute)'}]","[{'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009928', 'cui_str': 'Visual Contrast Sensitivity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1260959', 'cui_str': 'Drusen'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",30.0,0.0355068,"Statistically significant improvements in contrast sensitivity, central drusen volume, central drusen thickness, and quality of life were observed (P < 0.05).","[{'ForeName': 'Samuel N', 'Initials': 'SN', 'LastName': 'Markowitz', 'Affiliation': 'Department of Ophthalmology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Devenyi', 'Affiliation': 'Department of Ophthalmology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Marion R', 'Initials': 'MR', 'LastName': 'Munk', 'Affiliation': 'Department of Ophthalmology, Inselspital University Hospital Bern, Bern, Switzerland.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Croissant', 'Affiliation': 'LumiThera Inc, Poulsbo, Washington.'}, {'ForeName': 'Stephanie E', 'Initials': 'SE', 'LastName': 'Tedford', 'Affiliation': 'LumiThera Inc, Poulsbo, Washington.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Rückert', 'Affiliation': 'Eyegnos Consulting, Bern, Switzerland.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Walker', 'Affiliation': 'Walker Bioscience, Carlsbad, California.'}, {'ForeName': 'Beatriz E', 'Initials': 'BE', 'LastName': 'Patino', 'Affiliation': 'Department of Ophthalmology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Ophthalmology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Nido', 'Affiliation': 'Department of Ophthalmology, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Clark E', 'Initials': 'CE', 'LastName': 'Tedford', 'Affiliation': 'LumiThera Inc, Poulsbo, Washington.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002632']
3031,32078966,Mediators of youth anxiety outcomes 3 to 12 years after treatment.,"OBJECTIVE


Test changes in perceived coping efficacy, negative self-statements, and interpretive biases to threat during treatment as potential mediators of the relationship between randomly assigned treatment conditions and long-term anxiety follow-ups. Age at randomization was also tested as a moderator of mediational relationships.
METHOD


Participants included 319 youth (ages 7-17) from the Child/Adolescent Multimodal Study (CAMS) who participated in a naturalistic follow-up beginning an average of 6.5 years after the end of the CAMS intervention. The intervention conditions included cognitive behavioral therapy (CBT; Coping Cat), pharmacotherapy (sertraline), combined CBT and sertraline, and pill placebo. Putative mediators were measured four times during the intervention phase. Follow-up consisted of four annual assessments of current anxiety.
RESULTS


Reductions on a measure of interpretive bias to threat over the course of the combined condition intervention, as compared to the placebo condition, mediated anxiety outcomes at the first follow-up visit. This mediated effect was not significant for the CBT-only or sertraline-only conditions when compared to the placebo condition. No other significant mediated effects were found for putative mediators. Age did not significantly moderate any mediated effects.
CONCLUSION


Changes in youth-reported interpretive biases to threat over the course of combined youth anxiety interventions, as compared to a placebo intervention, may be associated with lower anxiety an average of 6.5 years following treatment.",2020,This mediated effect was not significant for the CBT-only or sertraline-only conditions when compared to the placebo condition.,['Participants included 319 youth (ages 7-17) from the Child/Adolescent Multimodal Study (CAMS) who participated in a naturalistic follow-up beginning an average of 6.5 years after the end of the CAMS intervention'],"['cognitive behavioral therapy (CBT; Coping Cat), pharmacotherapy (sertraline), combined CBT and sertraline, and pill placebo']",[],"[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],319.0,0.0503248,This mediated effect was not significant for the CBT-only or sertraline-only conditions when compared to the placebo condition.,"[{'ForeName': 'Heather B', 'Initials': 'HB', 'LastName': 'Makover', 'Affiliation': 'Department of Psychology, Temple University, 1301 North 13th Street, Philadelphia, PA, 19122, USA. Electronic address: heather.makover@temple.edu.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Kendall', 'Affiliation': 'Department of Psychology, Temple University, 1301 North 13th Street, Philadelphia, PA, 19122, USA. Electronic address: pkendall@temple.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Olino', 'Affiliation': 'Department of Psychology, Temple University, 1301 North 13th Street, Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Carper', 'Affiliation': 'Department of Psychology, Temple University, 1301 North 13th Street, Philadelphia, PA, 19122, USA.'}, {'ForeName': 'Anne Marie', 'Initials': 'AM', 'LastName': 'Albano', 'Affiliation': 'Columbia University Clinic for Anxiety and Related Disorders, 1775 Broadway, Suite 601, New York, NY, 10019, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Piacentini', 'Affiliation': 'UCLA Semel Institute, 760 Westwood Blvd, Rm 67-439, Los Angeles, CA, 90024, USA.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Peris', 'Affiliation': 'UCLA Semel Institute, 760 Westwood Blvd, Rm 67-439, Los Angeles, CA, 90024, USA.'}, {'ForeName': 'Audra K', 'Initials': 'AK', 'LastName': 'Langley', 'Affiliation': 'UCLA Semel Institute, 760 Westwood Blvd, Rm 67-439, Los Angeles, CA, 90024, USA.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Gonzalez', 'Affiliation': 'UCLA Semel Institute, 760 Westwood Blvd, Rm 67-439, Los Angeles, CA, 90024, USA.'}, {'ForeName': 'Golda S', 'Initials': 'GS', 'LastName': 'Ginsburg', 'Affiliation': 'The Johns Hopkins University School of Medicine, Division of Child and Adolescent Psychiatry, 550 North Broadway, Suite 202, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Compton', 'Affiliation': 'Duke University Medical Center, Department of Psychiatry and Behavioral Sciences, DUMC Box 3527, Durham, NC, 27710, USA.'}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Birmaher', 'Affiliation': ""University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic, 3811 O'Hara Street, Pittsburgh, PA, 15213, USA.""}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Sakolsky', 'Affiliation': ""University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic, 3811 O'Hara Street, Pittsburgh, PA, 15213, USA.""}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Keeton', 'Affiliation': 'The Johns Hopkins University School of Medicine, Division of Child and Adolescent Psychiatry, 550 North Broadway, Suite 202, Baltimore, MD, 21205, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Walkup', 'Affiliation': 'Division of Child and Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences at Northwestern University Feinberg School of Medicine, 446 East Ontario, Suite 7-200, Chicago, IL, 60611, USA.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102188']
3032,29929387,Malingering and Defensiveness on the Spanish Personality Assessment Inventory: An Initial Investigation with Mostly Spanish-Speaking Outpatients.,"Psychological assessments can be essentially invalidated by examinees' intentional response styles, such as  feigning  (i.e., fabrication or marked overreporting of symptoms/impairment) and  defensiveness  (i.e., denial or minimization of symptoms/impairment). As a psychometric strength, the Personality Assessment Inventory (PAI) has established validity indicators for identifying both response styles. With the United States' increasing ethnic and cultural diversity, predominantly Spanish-speaking individuals are now estimated in the range of 15 million persons. Unfortunately, very little research has been conducted on the Spanish-translated PAI regarding its effectiveness in clinical populations. Using a between-subjects design, a sample of mostly Spanish-speaking outpatients was randomly assigned to genuine, feigning, or defensive conditions. For feigning, PAI malingering indicators using rare symptoms strategies (i.e., Negative Impression [NIM] and Negative Distortion [NDS] scales) demonstrated moderate to large effect sizes. For defensiveness, the Defensive (DEF) index proved the most effective with a very large effect size ( M  = 1.68). Different cut scores were examined to increase the clinical utility of the Spanish PAI for determining response styles.",2020,"For defensiveness, the Defensive (DEF) index proved the most effective with a very large effect size ( M = 1.68).",[],[],"['Malingering and Defensiveness on the Spanish Personality Assessment Inventory', 'For defensiveness, the Defensive (DEF) index']",[],[],"[{'cui': 'C0024630', 'cui_str': 'Malingering'}, {'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0031209', 'cui_str': 'Personality Assessment'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0158233,"For defensiveness, the Defensive (DEF) index proved the most effective with a very large effect size ( M = 1.68).","[{'ForeName': 'Amor A', 'Initials': 'AA', 'LastName': 'Correa', 'Affiliation': 'Federal Medical Center Carswell, Fort Worth, TX, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Rogers', 'Affiliation': 'University of North Texas, Denton, TX, USA.'}, {'ForeName': 'Margot M', 'Initials': 'MM', 'LastName': 'Williams', 'Affiliation': 'University of North Texas, Denton, TX, USA.'}]",Assessment,['10.1177/1073191118778895']
3033,31821071,"CYP2D6  Genotype-Guided Tamoxifen Dosing in Hormone Receptor-Positive Metastatic Breast Cancer (TARGET-1): A Randomized, Open-Label, Phase II Study.","PURPOSE


In patients taking tamoxifen, the  CYP2D6  genotype causes different exposure of active metabolite endoxifen. The objective of this randomized, open-label, multicenter, phase II study was to prospectively evaluate whether  CYP2D6  genotype-guided tamoxifen dosing in patients with hormone receptor-positive metastatic breast cancer could have an impact on the clinical outcome.
METHODS


Patients who needed first-line tamoxifen therapy were enrolled. Based on individual  CYP2D6  genotype, patients heterozygous (wild type [wt]/variant [V]) or homozygous (V/V) for variant alleles of decreased or no function were randomly assigned to receive tamoxifen at an increased dose (ID arm; 40 mg daily) or regular dose (RD arm; 20 mg daily), and patients homozygous for wild-type alleles (wt/wt) received tamoxifen at 20 mg daily. The primary endpoint was the progression-free survival (PFS) rate at 6 months. The secondary endpoints included PFS and correlation of Z-endoxifen concentration with clinical outcomes.
RESULTS


Between December 2012 and July 2016, 186 patients were enrolled in Japan. Of 184 evaluable patients, 136 carried wt/V or V/V (ID arm, 70; RD arm, 66), and 48 carried wt/wt. PFS rates at 6 months were not significantly different between the ID and RD arms (67.6%  v  66.7%). The serum trough concentrations of Z-endoxifen in the ID arm were significantly higher than those in the RD arm (median, 89.2 nM  v  51.1 nM;  P  < .0001) and were also higher compared with wt/wt patients (72.0 nM;  P  = .045). No significant difference in Z-endoxifen concentrations was observed between patients with disease progression and those who were progression free at 6 months ( P  = .43).
CONCLUSION


In patients with  CYP2D6 -variant alleles, increasing tamoxifen dosing did not achieve a higher PFS rate at 6 months. The  CYP2D6  genotype solely cannot explain individual variability in the efficacy of tamoxifen.",2020,"No significant difference in Z-endoxifen concentrations was observed between patients with disease progression and those who were progression free at 6 months ( P  = .43).
","['patients heterozygous (wild type [wt]/variant [V]) or homozygous (V/V) for variant alleles of decreased or no function', 'Between December 2012 and July 2016', 'Patients who needed first-line tamoxifen therapy were enrolled', '184 evaluable patients, 136 carried wt/V or V/V (ID arm, 70; RD arm, 66), and 48 carried wt/wt', 'patients with hormone receptor-positive metastatic breast cancer', '186 patients were enrolled in Japan', 'Hormone Receptor-Positive Metastatic Breast Cancer (TARGET-1']","['CYP2D6  Genotype-Guided Tamoxifen', 'CYP2D6  genotype-guided tamoxifen', 'tamoxifen']","['PFS and correlation of Z-endoxifen concentration with clinical outcomes', 'serum trough concentrations of Z-endoxifen', 'Z-endoxifen concentrations', 'progression-free survival (PFS) rate', 'PFS rate', 'PFS rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0560268', 'cui_str': 'Volume fraction'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C4510392', 'cui_str': 'Tamoxifen therapy'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0206243', 'cui_str': 'Carrying'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0057223', 'cui_str': 'CYP2D6'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0957573', 'cui_str': '4-hydroxy-N-desmethyltamoxifen, (Z)-isomer'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",136.0,0.0561009,"No significant difference in Z-endoxifen concentrations was observed between patients with disease progression and those who were progression free at 6 months ( P  = .43).
","[{'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Tamura', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Chiyo K', 'Initials': 'CK', 'LastName': 'Imamura', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Takano', 'Affiliation': 'Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Shigehira', 'Initials': 'S', 'LastName': 'Saji', 'Affiliation': 'Fukushima Medical University, Fukushima, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Kan', 'Initials': 'K', 'LastName': 'Yonemori', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Tsurutani', 'Affiliation': 'Kindai University, Osaka, Japan.'}, {'ForeName': 'Reiki', 'Initials': 'R', 'LastName': 'Nishimura', 'Affiliation': 'Kumamoto Shinto General Hospital, Kumamoto, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Tokyo-West Tokushukai Hospital, Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Kitani', 'Affiliation': 'Seirei Sakura Citizen Hospital, Chiba, Japan.'}, {'ForeName': 'Naoto T', 'Initials': 'NT', 'LastName': 'Ueno', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Taisei', 'Initials': 'T', 'LastName': 'Mushiroda', 'Affiliation': 'RIKEN Center for Integrative Medical Sciences, Yokohama, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Kubo', 'Affiliation': 'RIKEN Center for Integrative Medical Sciences, Yokohama, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Fujiwara', 'Affiliation': 'National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Tanigawara', 'Affiliation': 'Keio University School of Medicine, Tokyo, Japan.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01412']
3034,31403668,A Web-Based HIV/STD Prevention Intervention for Divorced or Separated Older Women.,"BACKGROUND AND OBJECTIVE


Sexually transmitted diseases (STDs) are increasing among older adults concomitant with a rise in divorce after the age of 50 years. The objective of this study was to examine the effectiveness of a web-based human immunodeficiency virus (HIV)/STD risk reduction intervention for divorced and separated women aged more than 50 years.
RESEARCH DESIGN AND METHODS


Two hundred nineteen divorced or separated women, aged 50 years and older, participated in 60-day randomized pre-post control group study. Recruitment occurred via health agencies in Boston and Columbia, SC, and Craigslist advertisements placed in Boston, Columbia, Charleston, New York City, Washington DC, Baltimore, Chicago, Atlanta, Orlando, and Miami.
RESULTS


Intervention group reported greater intention to practice safe sex compared to the control group (B = .55, p = .03). Intention to practice safe sex differed by perceived stress (B = .15, p = .005), with no difference between control and intervention groups for those with low levels of stress. For high levels of stress, intervention group reported greater intention to practice safe sex compared to controls. Sexual risk was reduced by 6.10 points (SD: 1.10), and self-efficacy for sexual discussion was increased by 2.65 points (SD: 0.56) in the intervention group.
DISCUSSION AND IMPLICATIONS


A web-based intervention represents a promising tool to reduce HIV/STD risk among older women. Offering HIV/STD education in the context of other topics of interest to at-risk older women, such as divorce, may solve the problem of at-risk older women not seeking out prevention information due to lack of awareness of their heightened risk.",2020,Intention to practice safe sex differed by perceived stress,"['Two hundred nineteen divorced or separated women, aged 50 years and older, participated in 60-day randomized pre-post control group study', 'older adults concomitant with a rise in divorce after the age of 50 years', 'Divorced or Separated Older Women', 'older women', 'divorced and separated women aged more than 50 years']","['STD Prevention Intervention', 'web-based human immunodeficiency virus (HIV)/STD risk reduction intervention']","['Sexual risk', 'self-efficacy for sexual discussion', 'greater intention to practice safe sex']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0086170', 'cui_str': 'Divorced'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0521999', 'cui_str': 'Age more than 50 years (finding)'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}]",,0.0513786,Intention to practice safe sex differed by perceived stress,"[{'ForeName': 'Patricia Flynn', 'Initials': 'PF', 'LastName': 'Weitzman', 'Affiliation': 'Environment and Health Group, Cambridge, Massachusetts.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Environment and Health Group, Cambridge, Massachusetts.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Kogelman', 'Affiliation': ""Infectious Diseases Clinic, Traveler's Health Service, Tufts University School of Medicine, Boston, Massachusetts.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Mack', 'Affiliation': 'Environment and Health Group, Cambridge, Massachusetts.'}, {'ForeName': 'Jie Yang', 'Initials': 'JY', 'LastName': 'Sharir', 'Affiliation': 'Environment and Health Group, Cambridge, Massachusetts.'}, {'ForeName': 'Sara Romero', 'Initials': 'SR', 'LastName': 'Vicente', 'Affiliation': 'Environment and Health Group, Cambridge, Massachusetts.'}, {'ForeName': 'Sue E', 'Initials': 'SE', 'LastName': 'Levkoff', 'Affiliation': 'Environment and Health Group, Cambridge, Massachusetts.'}]",The Gerontologist,['10.1093/geront/gnz098']
3035,32118604,CORR Insights®: Does Preoperative Decolonization Reduce Surgical Site Infections in Elective Orthopaedic Surgery? A Prospective Randomized Controlled Trial.,,2020,,[],['CORR Insights®'],[],[],[],[],,0.0565187,,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schlatterer', 'Affiliation': 'D. Schlatterer, Vice Chair, Department of Orthopedic Surgery, Atlanta Medical Center, Atlanta, GA, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001199']
3036,32110003,Lifestyle Matters Randomized Controlled Trial of a Preventive Health Intervention for Older People: Qualitative Sub Study with Participants and Intervention Facilitators.,"Objective


This qualitative study embedded within a randomized controlled trial was conducted to explore the acceptability, experiences of, and short-term impact of a preventive health intervention (Lifestyle Matters) from the perspectives of those who took part, and to uncover any evidence for the theorised mechanisms of action (improved participation and self efficacy) underpinning the intervention. It was also conducted to help explain the quantitative trial results.
Methods


A purposive sample of 13 trial participants who had been randomized to receive the Lifestyle Matters intervention (approximately 10%) were individually qualitatively interviewed immediately following their involvement. All four intervention facilitators were also individually interviewed.
Results


Evidence of the hypothesized behavioural changes could be identified within the interview data, demonstrating the potential of this intervention. However, lack of adherence to the overall intervention eroded receipt of benefit. This finding complements the quantitative trial results which found that the study had failed to recruit those who considered themselves to be at risk of age-related decline.
Conclusion


This form of preventive health intervention requires proactive identification of those who recognise the need to make lifestyle changes. This is difficult if reactive health and social care systems are the main referral routes. The methodological approaches taken towards the study of complex interventions requires reconsideration if potential benefits are to be accurately assessed.
Clinical Trial Registration


ISRCTN67209155.",2020,"Results


Evidence of the hypothesized behavioural changes could be identified within the interview data, demonstrating the potential of this intervention.","['Methods\n\n\nA purposive sample of 13 trial participants who had been randomized to receive the', 'Older People']","['preventive health intervention (Lifestyle Matters', 'Preventive Health Intervention', 'Lifestyle Matters intervention']",[],"[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0033109', 'cui_str': 'Preventive Health'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]",[],13.0,0.0902491,"Results


Evidence of the hypothesized behavioural changes could be identified within the interview data, demonstrating the potential of this intervention.","[{'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Mountain', 'Affiliation': 'School of Health and Related Research, Faculty of Medicine, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Sprange', 'Affiliation': 'Faculty of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Chatters', 'Affiliation': 'School of Health and Related Research, Faculty of Medicine, University of Sheffield, Sheffield, UK.'}]",Clinical interventions in aging,['10.2147/CIA.S232108']
3037,30843231,"Pulsed-dye laser as an adjuvant treatment for papulopustular eruptions from epidermal growth factor receptor inhibitors, a randomized blinded split-faced controlled trial.","OBJECTIVES


To investigate the efficacy of pulsed-dye laser (PDL) as an adjunctive treatment for facial papulopustular eruptions from EGFR inhibitors (EGFRi).
METHODS


Fourteen patients with facial acneiform eruptions were recruited. Half side of the face was randomized to receive PDL treatment while the other side served as a control. The treatments were delivered every 2 weeks for 4 sessions. The patients were seen at baseline, weeks 2, 4, 6, 8, and 10. Erythema index (EI) measured by colorimeter, the papulopustular lesion count and physician global assessment (PGA) were obtained. Patients were allowed to use their standard treatments for their eruptions.
RESULTS


Both arms had a significant decrease in EI from baseline at each subsequent visit. In the laser treated side, the mean (95%CI) EI decreased from 23.5 (22.24-24.76) at baseline to 16.3 (15.01-17.59) at week 10, while those of the sham were 23.49 (22.23-24.75) to 20.51 (19.22-21.8), respectively. The mean change was significantly lower in the PDL arm from week 4 onwards. The lesion counts in both groups also decreased significantly, but the mean difference between the arms was not different. PGA scores followed the same pattern as EI.
CONCLUSIONS


Adjunctive treatment with PDL was a safe and effective treatment. Lasers Surg. Med. © 2019 Wiley Periodicals, Inc.",2019,"The lesion counts in both groups also decreased significantly, but the mean difference between the arms was not different.","['Fourteen patients with facial acneiform eruptions were recruited', 'facial papulopustular eruptions from EGFR inhibitors (EGFRi', '2019', 'papulopustular eruptions from epidermal growth factor receptor inhibitors']","['Pulsed-dye laser', 'PDL', 'pulsed-dye laser (PDL']","['lesion counts', 'mean (95%CI) EI', 'PGA scores', 'mean change', 'Erythema index (EI) measured by colorimeter, the papulopustular lesion count and physician global assessment (PGA']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175167', 'cui_str': 'Acneiform Eruptions'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0034802', 'cui_str': 'c-erbB-1 Protein'}]","[{'cui': 'C1289859', 'cui_str': 'Pulsed Dye Lasers'}, {'cui': 'C0392258', 'cui_str': 'Lasers, Tunable Dye'}]","[{'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",14.0,0.0261005,"The lesion counts in both groups also decreased significantly, but the mean difference between the arms was not different.","[{'ForeName': 'Pawinee', 'Initials': 'P', 'LastName': 'Rerknimitr', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Skin and Allergy Research Unit, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Yada', 'Initials': 'Y', 'LastName': 'Suphankong', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Skin and Allergy Research Unit, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Ratchathorn', 'Initials': 'R', 'LastName': 'Panchaprateep', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Skin and Allergy Research Unit, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Kerr', 'Affiliation': 'Center for Excellence in Biostatistics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Pravit', 'Initials': 'P', 'LastName': 'Asawanonda', 'Affiliation': 'Division of Dermatology, Department of Medicine, Faculty of Medicine, Skin and Allergy Research Unit, Chulalongkorn University, Bangkok, Thailand.'}]",Lasers in surgery and medicine,['10.1002/lsm.23080']
3038,32114586,Effects of Edaravone on Neurological Function and Tumor Necrosis Factor Alpha and Interleukin 8 Levels in Patients with Cerebral Infarction.,"OBJECTIVE


The present study aimed to explore the effects of edaravone on neurological function, tumor necrosis factor α (TNF-α), and interleukin (IL)-8 levels in patients with cerebral infarction.
METHODS


A total of 96 patients with cerebral -infarction who were admitted to the department of neurology in our hospital were enrolled in the present study, and they were randomly assigned to Group A (n = 48) and Group B (n = 48). Group A was treated with conventional therapy plus edaravone for 2 weeks and Group B with conventional therapy alone for 2 weeks. Enzyme-linked immunosorbent assay was used to determine serum TNF-α and IL-8 levels before and after treatment, and Pearson correlation analysis was conducted to analyze the correlation between serum TNF-α and IL-8 levels as well as National Institutes of Health Stroke Scale (NIHSS) score.
RESULTS


After treatment, Group A had a lower NIHSS score and serum TNF-α and IL-8 levels as well as higher activities of daily living score than Group B (all p < 0.05). In addition, after treatment, no significant differences were observed between the 2 groups in terms of the presence of adverse reactions (p > 0.05). Pearson correlation analysis revealed a significant positive correlation between serum TNF-α and IL-8 levels as well as NIHSS score (r = -0.567 and r = -0.556, both p < 0.05).
CONCLUSION


Edaravone can improve the neurological function of patients without causing evident adverse reactions, thereby improving quality of life, which may be correlated to decreased serum TNF-α and IL-8 levels.",2020,"After treatment, Group A had a lower NIHSS score and serum TNF-α and IL-8 levels as well as higher activities of daily living score than Group B (all p < 0.05).","['Patients with Cerebral Infarction', '96 patients with cerebral -infarction who were admitted to the department of neurology in our hospital were enrolled in the present study', 'patients with cerebral infarction']","['conventional therapy plus edaravone', 'edaravone', 'Edaravone']","['serum TNF-α and IL-8 levels as well as National Institutes of Health Stroke Scale (NIHSS) score', 'Neurological Function and Tumor Necrosis Factor Alpha and Interleukin 8 Levels', 'NIHSS score', 'higher activities of daily living score', 'lower NIHSS score and serum TNF-α and IL-8 levels', 'presence of adverse reactions', 'quality of life', 'serum TNF-α and IL-8 levels', 'neurological function', 'neurological function, tumor necrosis factor α (TNF-α), and interleukin (IL)-8 levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007785', 'cui_str': 'Cerebral Infarction'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027767', 'cui_str': 'Nervous System Physiology'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0034380'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}]",96.0,0.0377349,"After treatment, Group A had a lower NIHSS score and serum TNF-α and IL-8 levels as well as higher activities of daily living score than Group B (all p < 0.05).","[{'ForeName': 'Xiushan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of Hebei University of Engineering, Handan, China.'}, {'ForeName': 'Dongzhou', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of Hebei University of Engineering, Handan, China.'}, {'ForeName': 'Guozhu', 'Initials': 'G', 'LastName': 'Sun', 'Affiliation': 'Department of Neurosurgery, The Second Hospital of Hebei Medical University, Shijiazhuang, China, gzzzs2@163.com.'}]",European neurology,['10.1159/000505776']
3039,32113309,Assessment of speech impairment in patients with Parkinson's disease from acoustic quantifications of oral diadochokinetic sequences.,"This investigation aimed at determining whether an acoustic quantification of the oral diadochokinetic (DDK) task may be used to predict the perceived level of speech impairment when speakers with Parkinson's disease (PD) are reading a standard passage. DDK sequences with repeated [pa], [ta], and [ka] syllables were collected from 108 recordings (68 unique speakers with PD), along with recordings of the speakers reading a standardized text. The passage readings were assessed in five dimensions individually by four speech-language pathologists in a blinded and randomized procedure. The 46 acoustic DDK measures were merged with the perceptual ratings of read speech in the same recording session. Ordinal regression models were trained repeatedly on 80% of ratings and acoustic DDK predictors per dimension in 10-folds, and evaluated in testing data. The models developed from [ka] sequences achieved the best performance overall in predicting the clinicians' ratings of passage readings. The developed [pa] and [ta] models showed a much lower performance across all dimensions. The addition of samples with severe impairments and further automation of the procedure is required for the models to be used for screening purposes by non-expert clinical staff.",2020,The passage readings were assessed in five dimensions individually by four speech-language pathologists in a blinded and randomized procedure.,"[""patients with Parkinson's disease from acoustic quantifications of oral diadochokinetic sequences"", ""speakers with Parkinson's disease (PD""]",['oral diadochokinetic (DDK) task'],['perceptual ratings of read speech'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]",108.0,0.036499,The passage readings were assessed in five dimensions individually by four speech-language pathologists in a blinded and randomized procedure.,"[{'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Karlsson', 'Affiliation': 'Department of Clinical Science, Speech and Language Pathology, Umeå University, Umeå SE90187, Sweden.'}, {'ForeName': 'Ellika', 'Initials': 'E', 'LastName': 'Schalling', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Division of Speech and Language Pathology, Karolinska Institutet, Stockholm SE14186, Sweden.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Laakso', 'Affiliation': 'Institute of Neuroscience and Physiology, Department of Health and Rehabilitation, University of Gothenburg, Gothenburg SE40530, Sweden.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Johansson', 'Affiliation': 'Department of Clinical Science, Intervention and Technology, Division of Speech and Language Pathology, Karolinska Institutet, Stockholm SE14186, Sweden.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Hartelius', 'Affiliation': 'Institute of Neuroscience and Physiology, Department of Health and Rehabilitation, University of Gothenburg, Gothenburg SE40530, Sweden.'}]",The Journal of the Acoustical Society of America,['10.1121/10.0000581']
3040,32066146,Adverse Effects of Low-Dose Methotrexate: A Randomized Trial.,"Background


Low-dose methotrexate (LD-MTX) is the most commonly used drug for systemic rheumatic diseases worldwide and is the recommended first-line agent for rheumatoid arthritis. Despite extensive clinical use for more than 30 years, few data on adverse event (AE) rates derive from randomized, placebo-controlled trials, where both causality and magnitude of risk can be inferred.
Objective


To investigate AE rates, risk, and risk differences comparing LD-MTX versus placebo.
Design


Prespecified secondary analyses of a double-blind, placebo-controlled, randomized trial. (ClinicalTrials.gov: NCT01594333).
Setting


North America.
Participants


Adults with known cardiovascular disease and diabetes or metabolic syndrome.
Intervention


Random allocation to LD-MTX (≤20 mg/wk) or placebo. All participants received folic acid, 1 mg/d, 6 days per week.
Measurements


Risks for specific AEs of interest, as well as for all AEs, were compared across treatment groups after blinded adjudication.
Results


After an active run-in period, 6158 patients were enrolled and 4786 randomly assigned to a group; median follow-up was 23 months and median dosage 15 mg/wk. Among the randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2. Of 2391 participants assigned to LD-MTX, 2080 (87.0%) had an AE of interest, compared with 1951 of 2395 (81.5%) assigned to placebo (hazard ratio [HR], 1.17 [95% CI, 1.10 to 1.25]). The relative hazards of gastrointestinal (HR, 1.91 [CI, 1.75 to 2.10]), pulmonary (HR, 1.52 [CI, 1.16 to 1.98]), infectious (HR, 1.15 [CI, 1.01 to 1.30]), and hematologic (HR, 1.15 [CI, 1.07 to 1.23]) AEs were elevated for LD-MTX versus placebo. With the exception of increased risk for skin cancer (HR, 2.05 [CI, 1.28 to 3.28]), the treatment groups did not differ in risk for other cancer or mucocutaneous, neuropsychiatric, or musculoskeletal AEs. Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
Limitation


The trial was done in patients without rheumatic disease who tolerated LD-MTX during an active run-in period.
Conclusion


Use of LD-MTX was associated with small to moderate elevations in risks for skin cancer and gastrointestinal, infectious, pulmonary, and hematologic AEs, whereas renal AEs were decreased.
Primary Funding Source


National Institutes of Health.",2020,"Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
","['6158 patients', 'patients without rheumatic disease who tolerated LD-MTX during an active run-in period', 'randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2', '2391 participants assigned to', 'Participants\n\n\nAdults with known cardiovascular disease and diabetes or metabolic syndrome']","['placebo', '\n\n\nLow-dose methotrexate (LD-MTX', 'LD-MTX', 'Low-Dose Methotrexate', 'LD-MTX versus placebo', 'folic acid']","['increased risk for skin cancer', 'Renal AEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035435', 'cui_str': 'Rheumatism'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}]",6158.0,0.678699,"Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]).
","[{'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Solomon', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Glynn', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Elizabeth W', 'Initials': 'EW', 'LastName': 'Karlson', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Fengxin', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Cassandra', 'Initials': 'C', 'LastName': 'Corrigan', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Colls', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'MacFadyen', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Medha', 'Initials': 'M', 'LastName': 'Barbhaiya', 'Affiliation': 'Hospital for Special Surgery, New York, New York (M.B.).'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Berliner', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Dellaripa', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Brendan M', 'Initials': 'BM', 'LastName': 'Everett', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Aruna D', 'Initials': 'AD', 'LastName': 'Pradhan', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Hammond', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Murray', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Deepak A', 'Initials': 'DA', 'LastName': 'Rao', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Susan Y', 'Initials': 'SY', 'LastName': 'Ritter', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rutherford', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Sparks', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Stratton', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Dong H', 'Initials': 'DH', 'LastName': 'Suh', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Sara K', 'Initials': 'SK', 'LastName': 'Tedeschi', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Kathleen M M', 'Initials': 'KMM', 'LastName': 'Vanni', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Nina P', 'Initials': 'NP', 'LastName': 'Paynter', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Ridker', 'Affiliation': ""Brigham and Women's Hospital, Boston, Massachusetts (D.H.S., R.J.G., E.W.K., F.L., C.C., J.C., C.X., J.M., N.B., P.F.D., B.M.E., A.D.P., S.P.H., M.M., D.A.R., S.Y.R., A.R., J.A.S., J.S., D.H.S., S.K.T., K.M.V., N.P.P., P.M.R.).""}]",Annals of internal medicine,['10.7326/M19-3369']
3041,32112365,Effect of topical administration of propolis in chronic periodontitis.,"To investigate the effect of topical administration of propolis (a honeybee product) or curry leaf (an herbal product) into the periodontal pockets of periodontitis patients, a double-blind controlled clinical trial was conducted with 24 subjects including one drop-out diagnosed with moderate-to-advanced chronic periodontitis who completed initial periodontal therapy. They were randomly allocated to the following treatments: placebo, propolis, curry leaf, and minocycline. Gingival crevicular fluid (GCF) samples collected before and after the intervention were analyzed to quantify the number of total bacteria and number of six major periodontopathic bacteria by real-time PCR. Periodontitis-related clinical parameters were also analyzed. Among the six propolis-treated patients whose GCF samples were P. gingivalis-positive, three patients converted to be P. gingivalis-negative after the intervention. The minocycline-treated group exhibited a decrease in probing pocket depth (PPD) with statistically significant improvement, but not gain of clinical attachment level (CAL). Both PPD and CAL have been improved in the propolis-treated group at a statistically significant level, but not the curry leaf-treated group. In conclusion, treatment with propolis significantly improved both PPD and CAL, together with a tendency towards reduced P. gingivalis burden in GCF. It is likely that a propolis-based therapy becomes an alternative treatment option for chronic periodontitis during supportive periodontal therapy.",2020,"The minocycline-treated group exhibited a decrease in probing pocket depth (PPD) with statistically significant improvement, but not gain of clinical attachment level (CAL).","['chronic periodontitis', '24 subjects including one drop-out diagnosed with moderate-to-advanced chronic periodontitis who completed initial periodontal therapy']","['placebo, propolis, curry leaf, and minocycline', 'propolis (a honeybee product) or curry leaf (an herbal product', 'minocycline']","['probing pocket depth (PPD', 'PPD and CAL', 'gain of clinical attachment level (CAL', 'Gingival crevicular fluid (GCF) samples']","[{'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0033488', 'cui_str': 'Propolis'}, {'cui': 'C0453254', 'cui_str': 'Curry leaf (substance)'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C0323351', 'cui_str': 'Apis mellifera (organism)'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}]","[{'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]",24.0,0.150439,"The minocycline-treated group exhibited a decrease in probing pocket depth (PPD) with statistically significant improvement, but not gain of clinical attachment level (CAL).","[{'ForeName': 'Ryoma', 'Initials': 'R', 'LastName': 'Nakao', 'Affiliation': 'Department of Bacteriology I, National Institute of Infectious Diseases, 1-23-1 Toyama, Shinjuku-ku, Tokyo, 162-8640, Japan. ryoma73@nih.go.jp.'}, {'ForeName': 'Hidenobu', 'Initials': 'H', 'LastName': 'Senpuku', 'Affiliation': 'Department of Bacteriology I, National Institute of Infectious Diseases, 1-23-1 Toyama, Shinjuku-ku, Tokyo, 162-8640, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Ohnishi', 'Affiliation': 'Department of Bacteriology I, National Institute of Infectious Diseases, 1-23-1 Toyama, Shinjuku-ku, Tokyo, 162-8640, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Takai', 'Affiliation': 'Department of Periodontology, Nihon University School of Dentistry at Matsudo, Chiba, Japan.'}, {'ForeName': 'Yorimasa', 'Initials': 'Y', 'LastName': 'Ogata', 'Affiliation': 'Department of Periodontology, Nihon University School of Dentistry at Matsudo, Chiba, Japan.'}]",Odontology,['10.1007/s10266-020-00500-4']
3042,31626010,Not All Garden-I and II Femoral Neck Fractures in the Elderly Should Be Fixed: Effect of Posterior Tilt on Rates of Subsequent Arthroplasty.,"BACKGROUND


Internal fixation is currently the standard of care for Garden-I and II femoral neck fractures in elderly patients. However, there may be a degree of posterior tilt (measured on preoperative lateral radiograph) above which failure is likely, and primary arthroplasty would be preferred. The purpose of this analysis was to determine the association between posterior tilt and the risk of subsequent arthroplasty following internal fixation of Garden-I and II femoral neck fractures in elderly patients.
METHODS


This study is a preplanned secondary analysis of data collected in the FAITH (Fixation using Alternative Implants for the Treatment of Hip fractures) trial, an international, multicenter, randomized controlled trial comparing the sliding hip screw with cannulated screws in the treatment of femoral neck fractures in patients ≥50 years old. For each patient who sustained a Garden-I or II femoral neck fracture and had an adequate preoperative lateral radiograph, the amount of posterior tilt was categorized as <20° or ≥20°. Multivariable Cox proportional hazards analysis was used to assess the association between posterior tilt and subsequent arthroplasty during the 2-year follow-up period, controlling for potential confounders.
RESULTS


Of the 555 patients in the study sample, 67 (12.1%) had posterior tilt ≥20° and 488 (87.9%) had posterior tilt <20°. Overall, 73 (13.2%) of 555 patients underwent subsequent arthroplasty in the 24-month follow-up period. In the multivariable analysis, patients with posterior tilt ≥20° had a significantly higher risk of subsequent arthroplasty compared with those with posterior tilt <20° (22.4% [15 of 67] compared with 11.9% [58 of 488]; hazard ratio, 2.22; 95% confidence interval, 1.24 to 4.00; p = 0.008). The other factor associated with subsequent arthroplasty was age ≥80 years (p = 0.03).
CONCLUSIONS


In this analysis of patients with Garden-I and II femoral neck fractures, posterior tilt ≥20° was associated with a significantly increased risk of subsequent arthroplasty. Primary arthroplasty may be considered for Garden-I and II femoral neck fractures with posterior tilt ≥20°, especially among older patients.
LEVEL OF EVIDENCE


Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.",2019,"In the multivariable analysis, patients with posterior tilt ≥20° had a significantly higher risk of subsequent arthroplasty compared with those with posterior tilt <20° (22.4% [15 of 67] compared with 11.9% [58 of 488]; hazard ratio, 2.22; 95% confidence interval, 1.24 to 4.00; p = 0.008).","['555 patients in the study sample, 67 (12.1%) had posterior tilt ≥20° and 488 (87.9%) had posterior tilt <20°', 'femoral neck fractures in patients ≥50 years old', 'Garden-I and II femoral neck fractures in elderly patients', 'elderly patients', 'older patients']","['FAITH (Fixation using Alternative Implants', 'internal fixation of Garden-I and II femoral neck fractures', 'Posterior Tilt', 'sliding hip screw with cannulated screws']","['risk of subsequent arthroplasty', 'Rates of Subsequent Arthroplasty']","[{'cui': 'C4517810', 'cui_str': 'Five hundred and fifty-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4019428', 'cui_str': 'Gardens'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C4019428', 'cui_str': 'Gardens'}, {'cui': 'C0015806', 'cui_str': 'Femur Neck Fractures'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}]",555.0,0.0493184,"In the multivariable analysis, patients with posterior tilt ≥20° had a significantly higher risk of subsequent arthroplasty compared with those with posterior tilt <20° (22.4% [15 of 67] compared with 11.9% [58 of 488]; hazard ratio, 2.22; 95% confidence interval, 1.24 to 4.00; p = 0.008).","[{'ForeName': 'Kanu', 'Initials': 'K', 'LastName': 'Okike', 'Affiliation': 'Department of Orthopaedics, Kaiser Moanalua Medical Center, Honolulu, Hawaii.'}, {'ForeName': 'Ugochukwu N', 'Initials': 'UN', 'LastName': 'Udogwu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Marckenley', 'Initials': 'M', 'LastName': 'Isaac', 'Affiliation': 'Florida State University College of Medicine, Tallahassee, Florida.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Sprague', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Marc F', 'Initials': 'MF', 'LastName': 'Swiontkowski', 'Affiliation': 'Department of Orthopaedic Surgery, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Mohit', 'Initials': 'M', 'LastName': 'Bhandari', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gerard P', 'Initials': 'GP', 'LastName': 'Slobogean', 'Affiliation': 'Department of Orthopaedics, R Adams Cowley Shock Trauma Center, University of Maryland School of Medicine, Baltimore, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.18.01256']
3043,32112556,Integrated management of atrial fibrillation in primary care: results of the ALL-IN cluster randomized trial.,"AIMS


To evaluate whether integrated care for atrial fibrillation (AF) can be safely orchestrated in primary care.
METHODS AND RESULTS


The ALL-IN trial was a cluster randomized, open-label, pragmatic non-inferiority trial performed in primary care practices in the Netherlands. We randomized 26 practices: 15 to the integrated care intervention and 11 to usual care. The integrated care intervention consisted of (i) quarterly AF check-ups by trained nurses in primary care, also focusing on possibly interfering comorbidities, (ii) monitoring of anticoagulation therapy in primary care, and finally (iii) easy-access availability of consultations from cardiologists and anticoagulation clinics. The primary endpoint was all-cause mortality during 2 years of follow-up. In the intervention arm, 527 out of 941 eligible AF patients aged ≥65 years provided informed consent to undergo the intervention. These 527 patients were compared with 713 AF patients in the control arm receiving usual care. Median age was 77 (interquartile range 72-83) years. The all-cause mortality rate was 3.5 per 100 patient-years in the intervention arm vs. 6.7 per 100 patient-years in the control arm [adjusted hazard ratio (HR) 0.55; 95% confidence interval (CI) 0.37-0.82]. For non-cardiovascular mortality, the adjusted HR was 0.47 (95% CI 0.27-0.82). For other adverse events, no statistically significant differences were observed.
CONCLUSION


In this cluster randomized trial, integrated care for elderly AF patients in primary care showed a 45% reduction in all-cause mortality when compared with usual care.",2020,"For other adverse events, no statistically significant differences were observed.
","['elderly AF patients in primary care', 'primary care', '527 patients were compared with 713 AF patients in the control arm receiving usual care', 'Median age was 77 (interquartile range 72-83) years', '527 out of 941 eligible AF patients aged ≥65 years']","['integrated care for atrial fibrillation (AF', 'integrated care intervention and 11 to usual care', 'integrated care intervention consisted of (i) quarterly AF check-ups by trained nurses in primary care, also focusing on possibly interfering comorbidities, (ii) monitoring of anticoagulation therapy in primary care, and finally (iii) easy-access availability of consultations from cardiologists and anticoagulation clinics']","['cause mortality', 'mortality rate']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517805', 'cui_str': 'Five hundred and twenty-seven'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0332179', 'cui_str': 'q3mo'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C2362652', 'cui_str': 'Possible diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332219', 'cui_str': 'Easy (qualifier value)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0175906', 'cui_str': 'Cardiologists'}, {'cui': 'C3839946', 'cui_str': 'Anticoagulation clinic'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",26.0,0.0804642,"For other adverse events, no statistically significant differences were observed.
","[{'ForeName': 'Carline J', 'Initials': 'CJ', 'LastName': 'van den Dries', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht/Utrecht University, Str. 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands.'}, {'ForeName': 'Sander', 'Initials': 'S', 'LastName': 'van Doorn', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht/Utrecht University, Str. 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands.'}, {'ForeName': 'Frans H', 'Initials': 'FH', 'LastName': 'Rutten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht/Utrecht University, Str. 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands.'}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Oudega', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht/Utrecht University, Str. 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands.'}, {'ForeName': 'Sjef J C M', 'Initials': 'SJCM', 'LastName': 'van de Leur', 'Affiliation': 'Thrombosis Service, Isala Hospital Zwolle, Postbus 10400, 8000 GK Zwolle, the Netherlands.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Elvan', 'Affiliation': 'Department of Cardiology, Isala Hospital Zwolle, Postbus 10400, 8000 GK Zwolle, the Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Oude Grave', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht/Utrecht University, Str. 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands.'}, {'ForeName': 'Henk J G', 'Initials': 'HJG', 'LastName': 'Bilo', 'Affiliation': 'Department of Internal Medicine, Isala Hospital Zwolle, Postbus 10400, 8000 GK Zwolle, the Netherlands.'}, {'ForeName': 'Karel G M', 'Initials': 'KGM', 'LastName': 'Moons', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht/Utrecht University, Str. 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands.'}, {'ForeName': 'Arno W', 'Initials': 'AW', 'LastName': 'Hoes', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht/Utrecht University, Str. 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Geersing', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht/Utrecht University, Str. 6.131, PO Box 85500, 3508 GA Utrecht, the Netherlands.'}]",European heart journal,['10.1093/eurheartj/ehaa055']
3044,32106075,Effect of External Counterpulsation on Running Performance and Perceived Recovery.,"PURPOSE


To determine the efficacy of 20 minutes of external counterpulsation (ECP) on subsequent 1.2-km shuttle run test (1.2SRT) performance and perceived recovery following fatiguing high-intensity exercise.
METHODS


After familiarization, 13 recreationally active males (21.4 [1.9] y) participated in 2 experimental trials in a randomized crossover design. At 8:00 AM, participants completed a 1.2SRT, followed by an individualized high-intensity exercise bout and 20 minutes of ECP or supine passive rest (control). At 2:00 PM a second 1.2SRT was completed. Completion time for 1.2SRT (measured in seconds), heart rate, and Borg rating of perceived exertion were compared across conditions. Total quality of recovery and 100-mm visual analogue scale of perceived benefit of recovery were assessed at multiple time points.
RESULTS


A significantly smaller decline in PM 1.2SRT completion time compared with AM (baseline) was found for ECP compared with control (P = .008; moderate, very likely beneficial effect size of -0.77 [-1.53 to 0.05]). Total quality of recovery was significantly higher for ECP than control (P < .001), and perceived benefit of recovery was higher following ECP (P < .001, very large, most likely beneficial effect size of 2.08 [1.22 to 2.81]).
CONCLUSIONS


Twenty minutes of ECP was found to be an effective recovery modality for within-day, between-bouts exercise, positively influencing subsequent 1.2SRT performance and enhancing perceptual recovery. ECP may be applied as a viable alternative to optimize and accelerate the recovery process, particularly in the event of congested training or competition demands.",2020,"Total quality of recovery was significantly higher for ECP than control (P < .001), and perceived benefit of recovery was higher following ECP (P < .001, very large, most likely beneficial effect size of 2.08 [1.22 to 2.81]).
",['13 recreationally active males (21.4 [1.9]\xa0y) participated in 2 experimental trials'],"['ECP', 'External Counterpulsation', 'external counterpulsation (ECP', 'individualized high-intensity exercise bout and 20 minutes of ECP or supine passive rest (control']","['Total quality of recovery and 100-mm visual analogue scale of perceived benefit of recovery', 'PM 1.2SRT completion time', 'Running Performance and Perceived Recovery', 'Completion time for 1.2SRT (measured in seconds), heart rate, and Borg rating of perceived exertion', 'subsequent 1.2SRT performance and enhancing perceptual recovery', 'Total quality of recovery', 'benefit of recovery']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517517', 'cui_str': '1.9 (qualifier value)'}]","[{'cui': 'C0010217', 'cui_str': 'Counterpulsation, External'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}]",,0.219657,"Total quality of recovery was significantly higher for ECP than control (P < .001), and perceived benefit of recovery was higher following ECP (P < .001, very large, most likely beneficial effect size of 2.08 [1.22 to 2.81]).
","[{'ForeName': 'Suzanna', 'Initials': 'S', 'LastName': 'Russell', 'Affiliation': ''}, {'ForeName': 'Angus G', 'Initials': 'AG', 'LastName': 'Evans', 'Affiliation': ''}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Jenkins', 'Affiliation': ''}, {'ForeName': 'Vincent G', 'Initials': 'VG', 'LastName': 'Kelly', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0605']
3045,30630722,The Effect of a Multicomponent Intervention on Quality of Life in Residents of Nursing Homes: A Randomized Controlled Trial (COSMOS).,"OBJECTIVES


To investigate if the multicomponent intervention of the COSMOS trial, combining communication, systematic pain management, medication review, and activities, improved quality of life (QoL) in nursing home patients with complex needs.
DESIGN


Multicenter, cluster-randomized, single-blinded, controlled trial.
SETTING


Thirty-three nursing homes with 67 units (clusters) from 8 Norwegian municipalities.
PARTICIPANTS


Seven hundred twenty-three patients with and without dementia (≥65 years) were cluster randomized to usual care or intervention in which health care staff received standardized education and on-site training for 4 months with follow-up at month 9.
MEASUREMENTS


Primary outcome was change in QoL as measured by QUALIDEM (QoL dementia scale); QUALID (QoL late-stage dementia scale), and EQ-VAS (European QoL-visual analog scale) from baseline to month 4. Secondary outcomes were activities of daily living (ADL), total medication, staff distress, and clinical global impressions of change (CGIC).
RESULTS


During the active intervention, all 3 QoL measures worsened, 2 significantly (QUALID P = .04; QUALIDEM P = .002). However, follow-up analysis from month 4 to 9 showed an intervention effect for EQ-VAS (P = .003) and QUALIDEM total score (P = .01; care relationship P = .02; positive affect P = .04, social relations P = .01). The secondary outcomes of ADL function, reduction of medication (including psychotropics) and staff distress, improved significantly from baseline to month 4. Intervention effects were also demonstrated for CGIC at month 4 (P = .023) and 9 (P = .009), mainly because of deterioration in the control group.
CONCLUSION AND IMPLICATIONS


Temporarily, the QoL decreased in the intervention group, leading to our hypothesis that health care staff may be overwhelmed by the work-intensive COSMOS intervention period. However, the decrease reversed significantly during follow-up, indicating a potential learning effect. Further, the intervention group improved in ADL function and received less medication, and staff reported less distress and judged COSMOS as able to bring about clinically relevant change. This suggests that nonpharmacologic multicomponent interventions require long follow-up to ensure uptake and beneficial effects.",2019,"During the active intervention, all 3 QoL measures worsened, 2 significantly (QUALID P = .04; QUALIDEM P = .002).","['Seven hundred twenty-three patients with and without dementia (≥65\xa0years', 'Thirty-three nursing homes with 67 units (clusters) from 8 Norwegian municipalities', 'Residents of Nursing Homes', 'nursing home patients with complex needs']","['usual care or intervention in which health care staff received standardized education and on-site training for 4\xa0months with follow-up at month\xa09', 'Multicomponent Intervention']","['Quality of Life', 'ADL function', 'total score', 'QoL', 'quality of life (QoL', 'change in QoL as measured by QUALIDEM (QoL dementia scale); QUALID (QoL late-stage dementia scale), and EQ-VAS (European QoL-visual analog scale', 'ADL function, reduction of medication (including psychotropics) and staff distress', 'activities of daily living (ADL), total medication, staff distress, and clinical global impressions of change (CGIC', 'EQ-VAS']","[{'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0337812', 'cui_str': 'Norwegians (ethnic group)'}, {'cui': 'C0600182'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]","[{'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0034380'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0222045'}, {'cui': 'C1279941', 'cui_str': 'Late stage (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",723.0,0.124784,"During the active intervention, all 3 QoL measures worsened, 2 significantly (QUALID P = .04; QUALIDEM P = .002).","[{'ForeName': 'Bettina S', 'Initials': 'BS', 'LastName': 'Husebø', 'Affiliation': 'Department of Global Public Health and Primary Care, Centre for Elderly and Nursing Home Medicine, Faculty of Medicine, University of Bergen, Norway; Municipality of Bergen, Bergen, Norway. Electronic address: Bettina.Husebo@uib.no.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Ballard', 'Affiliation': 'University of Exeter Medical School, Exeter, United Kingdom; Centre for Age-Related Medicine, Stavanger University Hospital, Stavanger, Norway.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Aarsland', 'Affiliation': 'Centre for Age-Related Medicine, Stavanger University Hospital, Stavanger, Norway; Kings College, Institute of Psychiatry, Psychology and Neuroscience, London, United Kingdom.'}, {'ForeName': 'Geir', 'Initials': 'G', 'LastName': 'Selbaek', 'Affiliation': 'National Advisory Unit of Ageing and Health, Vestfold Hospital Trust, Tonsberg, Norway; Centre for Old Age Psychiatry Research, Innlandet Hospital Trust, Ottestad, Norway.'}, {'ForeName': 'Dagrun D', 'Initials': 'DD', 'LastName': 'Slettebo', 'Affiliation': 'Department of Global Public Health and Primary Care, Centre for Elderly and Nursing Home Medicine, Faculty of Medicine, University of Bergen, Norway.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Gulla', 'Affiliation': 'Department of Global Public Health and Primary Care, Centre for Elderly and Nursing Home Medicine, Faculty of Medicine, University of Bergen, Norway.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Aasmul', 'Affiliation': 'Department of Global Public Health and Primary Care, Centre for Elderly and Nursing Home Medicine, Faculty of Medicine, University of Bergen, Norway.'}, {'ForeName': 'Torstein', 'Initials': 'T', 'LastName': 'Habiger', 'Affiliation': 'Department of Global Public Health and Primary Care, Centre for Elderly and Nursing Home Medicine, Faculty of Medicine, University of Bergen, Norway.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Elvegaard', 'Affiliation': 'Department of Global Public Health and Primary Care, Centre for Elderly and Nursing Home Medicine, Faculty of Medicine, University of Bergen, Norway.'}, {'ForeName': 'Ingelin', 'Initials': 'I', 'LastName': 'Testad', 'Affiliation': 'Centre for Age-Related Medicine, Stavanger University Hospital, Stavanger, Norway; University of Exeter Medical School, Exeter, United Kingdom.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Flo', 'Affiliation': 'Department of Global Public Health and Primary Care, Centre for Elderly and Nursing Home Medicine, Faculty of Medicine, University of Bergen, Norway; Faculty of Psychology, University of Bergen, Norway.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2018.11.006']
3046,31994022,"Multiple-Ascending Dose Study in Healthy Subjects to Assess the Pharmacokinetics, Tolerability, and CYP3A4 Interaction Potential of the T-Type Calcium Channel Blocker ACT-709478, A Potential New Antiepileptic Drug.","BACKGROUND


ACT-709478 is a selective, orally available T-type calcium channel blocker being studied as a potential new treatment in epilepsy. ACT-709478 had previously been investigated in a single-ascending dose study up to a dose of 400 mg.
OBJECTIVES


The aim of this study was to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of ACT-709478. In addition, the drug-drug interaction potential of multiple doses of ACT-709478 with the cytochrome P450 3A4 substrate midazolam was investigated.
METHODS


This double-blind, placebo-controlled, randomized study included 46 healthy male and female subjects. Ascending multiple oral doses of ACT-709478 were administered to 10 (cohorts 1-2) or 12 (cohorts 3-4) subjects (two taking placebo per cohort). In cohorts 1-2, 30 or 10 mg ACT-709478 was administered once daily for 12 days. An up-titration regimen was used in cohorts 3-4 with administration of 10, 30, and 60 mg for 7 days each in both cohorts and an additional dose level of 100 mg ACT-709478 once daily for 8 days in cohort 4. Single doses of midazolam were administered at baseline and concomitantly to 60 mg and 100 mg ACT-709478 in cohort 4. Blood sampling for pharmacokinetic evaluations and safety assessments (clinical laboratory, vital signs, adverse events, and electrocardiogram) were performed regularly. Holter electrocardiograms were recorded at baseline and for 24 h at steady state and central nervous system effects were assessed with pharmacodynamic tests at baseline and steady state.
RESULTS


ACT-709478 was absorbed with a time to reach the maximum plasma concentration of 3.5-4.0 h and eliminated with a half-life of 45-53 h. Steady state was reached after 5-7 days of dosing and exposure increased dose-proportionally. An accumulation index of approximately three fold was observed in cohorts 1 and 2. Exposure to midazolam was lower upon concomitant administration of 60 and 100 mg ACT-709478 compared to midazolam alone while the half-life and time to reach the maximum plasma concentration of midazolam remained unchanged, suggesting a weak induction at the gastrointestinal but not hepatic level. Pharmacokinetic parameters of 1-hydroxymidazolam were not affected by ACT-709478 administration. The most frequent adverse events were dizziness, somnolence, and headache. A tolerability signal was detected in cohort 1 (30 mg once daily); therefore, the dose was decreased to 10 mg once daily in cohort 2. The subsequently established up-titration regimen, starting with 10 mg once daily, considerably improved tolerability. Multiple doses up to 100 mg once daily were well tolerated. No treatment-related effects were detected on vital signs, clinical laboratory tests, Holter electrocardiogram variables, or in the pharmacodynamic tests.
CONCLUSIONS


ACT-709478 exhibits good tolerability up to 100 mg once daily using an up-titration regimen and pharmacokinetic properties that support further clinical investigations. A weak induction of gastrointestinal cytochrome P450 3A4 activity was observed, unlikely to be of clinical relevance. CLINICALTRIALS.
GOV IDENTIFIER


NCT03165097.",2020,"No treatment-related effects were detected on vital signs, clinical laboratory tests, Holter electrocardiogram variables, or in the pharmacodynamic tests.
","['Healthy Subjects', '46 healthy male and female subjects']","['placebo', 'midazolam']","['maximum plasma concentration', 'Pharmacokinetic parameters of 1-hydroxymidazolam', 'tolerability', 'vital signs, clinical laboratory tests, Holter electrocardiogram variables, or in the pharmacodynamic tests', 'safety, tolerability, pharmacokinetics, and pharmacodynamics', 'tolerated', 'accumulation index', 'Blood sampling for pharmacokinetic evaluations and safety assessments (clinical laboratory, vital signs, adverse events, and electrocardiogram', 'dizziness, somnolence, and headache', 'tolerability signal', 'Holter electrocardiograms', 'Steady state']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0044411', 'cui_str': 'alpha-hydroxymidazolam'}, {'cui': 'C0518766'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005834', 'cui_str': 'Blood Specimen Collection'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}]",46.0,0.221884,"No treatment-related effects were detected on vital signs, clinical laboratory tests, Holter electrocardiogram variables, or in the pharmacodynamic tests.
","[{'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Richard', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland.'}, {'ForeName': 'Priska', 'Initials': 'P', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland. priska.kaufmann@idorsia.com.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Ort', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Kornberger', 'Affiliation': 'Parexel International GmbH, Berlin, Germany.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, 4123, Allschwil, Switzerland.'}]",CNS drugs,['10.1007/s40263-019-00697-1']
3047,31994024,Cardiac Safety of Esketamine Nasal Spray in Treatment-Resistant Depression: Results from the Clinical Development Program.,"BACKGROUND


An intranasal formulation of esketamine, combined with an oral antidepressant, is approved in the USA and the European Union for adults with treatment-resistant depression (TRD). Transient cardiovascular stimulatory effects have been reported with ketamine.
METHODS


Cardiovascular effects of esketamine nasal spray, combined with an oral antidepressant, were evaluated in 1708 esketamine-treated adults with TRD in six trials (five double-blind, placebo-controlled (486 placebo-treated patients); one open-label) of 4-52 weeks' duration. Patients with established cardiovascular disease, including uncontrolled hypertension (> 140/> 90 mmHg), history of hypertensive crisis, or clinically significant electrocardiogram (ECG) abnormalities, were excluded from enrollment. Effects on cardiac repolarization were assessed in a phase I randomized, positive- and active-controlled thorough corrected QT (QTc) interval study. For adverse events, odds ratio (OR) [95% confidence interval] for esketamine/antidepressant versus antidepressant/placebo was calculated.
RESULTS


Adverse events related to increased BP were reported in 12.8% of all esketamine-treated patients (in double-blind trials: esketamine/antidepressant 11.6% vs. antidepressant/placebo 3.9%; OR 3.2 [1.9-5.8]). Among the patients without a history of hypertension, new antihypertensive medication was initiated by 2.1% (6/280) of patients in the esketamine/antidepressant group versus 1.2% (2/171) of patients in the antidepressant/placebo group, in the double-blinded studies. Adverse events related to abnormal heart rate were reported in 3.0% of all esketamine-treated patients (in double-blind trials: 1.6% vs. 0.8%; OR 1.9 [0.5-8.6]). Overall, three cardiovascular adverse events related to BP increase were reported as serious and severe, and there was one fatal event considered unrelated (acute cardiac failure). BP increases reached the maximum postdose value within ~ 40 min of esketamine dosing and returned to the predose range by ~ 1.5 h postdose. In two studies (4-week duration, age 18-64 years), the largest mean maximum systolic/diastolic postdose BP increases were 13.3/8.7 mmHg for esketamine/antidepressant and 6.1/4.9 mmHg for antidepressant/placebo, and in a short-term elderly study (age ≥ 65 years) were 16.0/9.5 and 11.1/6.8 mmHg, respectively. Across studies/study phases, < 2% of patients discontinued esketamine due to adverse events of increased BP and tachycardia. No clinically relevant effect on ECG parameters was observed. Therapeutic and supratherapeutic doses of esketamine did not prolong the QTcF (QT corrected by Fridericia's equation) interval (baseline-corrected values of - 2.02 to 2.16 ms, and - 3.51 to 4.89 ms, respectively).
CONCLUSIONS


BP elevations following esketamine dosing are generally transient, asymptomatic, and not associated with serious cardiovascular safety sequalae. Further evaluation of long-term cardiovascular outcomes is warranted.",2020,"Therapeutic and supratherapeutic doses of esketamine did not prolong the QTcF (QT corrected by Fridericia's equation) interval (baseline-corrected values of - 2.02 to 2.16 ms, and - 3.51 to 4.89 ms, respectively).
","['adults with treatment-resistant depression (TRD', 'Patients with established cardiovascular disease, including uncontrolled hypertension (>\u2009140/>\u200990\xa0mmHg), history of hypertensive crisis, or clinically significant electrocardiogram (ECG) abnormalities, were excluded from enrollment', '1708 esketamine-treated adults with TRD in six trials (five double-blind', 'Treatment-Resistant Depression']","['esketamine nasal spray, combined with an oral antidepressant', 'placebo', 'placebo-controlled (486 placebo-treated patients); one open-label', 'Esketamine Nasal Spray']","['BP', 'BP and tachycardia', 'ECG parameters', 'cardiac repolarization', 'abnormal heart rate', ""QTcF (QT corrected by Fridericia's equation) interval"", 'largest mean maximum systolic/diastolic postdose BP increases']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0439083', 'cui_str': '>90 (qualifier value)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0020546', 'cui_str': 'Hypertensive crisis'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C2825616'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C2825616'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}]",1708.0,0.320118,"Therapeutic and supratherapeutic doses of esketamine did not prolong the QTcF (QT corrected by Fridericia's equation) interval (baseline-corrected values of - 2.02 to 2.16 ms, and - 3.51 to 4.89 ms, respectively).
","[{'ForeName': 'Teodora', 'Initials': 'T', 'LastName': 'Doherty', 'Affiliation': 'Neuroscience, Global Medical Organization, Janssen Research & Development, LLC, Titusville, NJ, USA. tdoherty@its.jnj.com.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Wajs', 'Affiliation': 'Janssen Research & Development, Belgium, Beerse, Belgium.'}, {'ForeName': 'Rama', 'Initials': 'R', 'LastName': 'Melkote', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'Neuroscience, Global Medical Organization, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Jaskaran B', 'Initials': 'JB', 'LastName': 'Singh', 'Affiliation': 'Janssen Research & Development, LLC, San Diego, CA, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Weber', 'Affiliation': 'State University of New York Downstate College of Medicine, Brooklyn, NY, USA.'}]",CNS drugs,['10.1007/s40263-020-00699-4']
3048,30888584,Cholecalciferol supplementation increases FGF23 in peritoneal dialysis patients with hypovitaminosis D: a randomized clinical trial.,"BACKGROUND


Vitamin D deficiency is common in peritoneal dialysis (PD) patients, so its supplementation has been advocated as potentially beneficial.
METHODS


Double-blind, placebo-controlled, randomized clinical trial. Subjects on PD treated with high calcium peritoneal dialysate (Ca 3.5 mEq/l) and serum levels of 25-hydroxi vitamin D (25D) < 20 ng/ml were randomized to receive cholecalciferol (4800 IU/daily) or placebo for 16 weeks. The outcome measures were the effects on the osteogenic biomarkers osteoprotegerin (primary endpoint), intact fibroblast growth factor-23 (iFGF23), osteocalcin, osteopontin, iPTH, 1,25-dyhydroxivitamin D (1,25D), and interleukin-6.
RESULTS


Fifty-eight subjects were randomly assigned. Baseline characteristics were similar in both groups. Cholecalciferol supplemented subjects had a significant increase in serum 25D (from 11.4 ± 5.0 to 28.3 ± 10.3 ng/ml), 1,25D and iFGF23 compared with placebo group. iFGF23 levels increased an average of 10,875 pg/ml per month (95% CI 11,778-88,414) in the cholecalciferol group and was unchanged in the placebo group (2829 pg/ml, 95% CI - 2181 to 14,972). Extremely high iFGF23 levels (> 30,000 pg/ml) were observed in 74% of subjects receiving cholecalciferol although iFGF23 returned to baseline values after 32 weeks of withdrawal. The observed changes in iFGF23 correlated with 1,25D levels and were not modified by other variables. No difference was observed between groups in osteoprotegerin or other osteogenic biomarkers levels.
CONCLUSIONS


Cholecalciferol supplementation increases serum 25D levels in subjects on PD exposed to high calcium dialysate, yet it induces an exponential increase of iFGF23 in most patients, which disappear after withdrawal of supplementation and may be a major concern for this maneuver.",2019,"The outcome measures were the effects on the osteogenic biomarkers osteoprotegerin (primary endpoint), intact fibroblast growth factor-23 (iFGF23), osteocalcin, osteopontin, iPTH, 1,25-dyhydroxivitamin D (1,25D), and interleukin-6.
","['peritoneal dialysis (PD) patients', 'Fifty-eight subjects', 'peritoneal dialysis patients with hypovitaminosis D', 'Subjects on PD treated with high']","['Cholecalciferol supplementation', 'Cholecalciferol', 'placebo', '25-hydroxi vitamin D (25D)\u2009<\u200920\xa0ng/ml were randomized to receive cholecalciferol', 'calcium peritoneal dialysate', 'cholecalciferol']","['serum 25D levels', 'iFGF23 levels', 'FGF23', 'serum 25D', 'osteogenic biomarkers osteoprotegerin (primary endpoint), intact fibroblast growth factor-23 (iFGF23), osteocalcin, osteopontin, iPTH, 1,25-dyhydroxivitamin D (1,25D), and interleukin-6']","[{'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0442034', 'cui_str': 'Peritoneal (qualifier value)'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1262886', 'cui_str': 'Osteoprotegerin'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C3272931', 'cui_str': 'FGF-23'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0069676', 'cui_str': 'Bone Sialoprotein 1'}, {'cui': 'C0047008', 'cui_str': 'IPTHS'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",58.0,0.699587,"The outcome measures were the effects on the osteogenic biomarkers osteoprotegerin (primary endpoint), intact fibroblast growth factor-23 (iFGF23), osteocalcin, osteopontin, iPTH, 1,25-dyhydroxivitamin D (1,25D), and interleukin-6.
","[{'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Ramirez-Sandoval', 'Affiliation': 'Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Dominguez Sección XVI, 14080, Mexico City, Mexico.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Arvizu-Hernandez', 'Affiliation': 'Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Dominguez Sección XVI, 14080, Mexico City, Mexico.'}, {'ForeName': 'Cristino', 'Initials': 'C', 'LastName': 'Cruz', 'Affiliation': 'Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Dominguez Sección XVI, 14080, Mexico City, Mexico.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Vazquez-Cantu', 'Affiliation': 'Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Dominguez Sección XVI, 14080, Mexico City, Mexico.'}, {'ForeName': 'Luis J', 'Initials': 'LJ', 'LastName': 'Rojas-Concha', 'Affiliation': 'Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Dominguez Sección XVI, 14080, Mexico City, Mexico.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Tamez', 'Affiliation': 'Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Dominguez Sección XVI, 14080, Mexico City, Mexico.'}, {'ForeName': 'Fagundo', 'Initials': 'F', 'LastName': 'Reynerio', 'Affiliation': 'Nutritional Physiology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'F Enrique', 'Initials': 'FE', 'LastName': 'Gomez', 'Affiliation': 'Central Laboratory, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Correa-Rotter', 'Affiliation': 'Department of Nephrology and Mineral Metabolism, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Belisario Dominguez Sección XVI, 14080, Mexico City, Mexico. correarotter@gmail.com.'}]",Journal of nephrology,['10.1007/s40620-019-00599-x']
3049,32107889,The association between changes in muscle mass and quality of life in patients with metastatic colorectal cancer.,"BACKGROUND


Skeletal muscle mass (SMM) loss is common in metastatic colorectal cancer (mCRC) patients and associated with poor clinical outcomes, including increased treatment-related toxicities and reduced survival. Muscle loss may contribute to reduced health-related quality of life (HRQoL), including fatigue. Our aim was to study associations between changes in SMM and concomitant changes in patient-reported HRQoL.
METHODS


This was a secondary analysis of mCRC patients in the CAIRO3 randomized clinical trial who were-after initial treatment-randomized between maintenance treatment with capecitabine plus bevacizumab (CAP-B) and observation until first disease progression (PD1). Included patients had computed tomography images for SMM quantification, together with HRQoL assessments available at randomization and PD1. Changes in SMM (categorized as >2% loss, stable, and >2% gain) and HRQoL were computed between randomization and PD1. Changes in HRQoL score >10 points were considered clinically relevant. Associations between SMM and HRQoL changes were studied by multiple linear regression models. We also investigated whether associations differed by treatment arm for global health and the 13 other HRQoL subscales.
RESULTS


Of 221 patients included (mean age 63.5 ± 8.4 years), 24% lost, 27% remained stable, and 49% gained SMM. At randomization, mean global health status was 73.5 ± 15.9 in the CAP-B arm and 75.1 ± 17.5 in the observation arm (P = 0.48). A stable or gain in SMM was significantly associated with a clinically relevant improvement in global health status (9.9 and 14.7 points, respectively), compared with patients who lost SMM. From the subscales that did not show significant differences between the two treatment arms, we found significant and clinically relevant associations for stable or gain in SMM with improved role functioning (12.0 and 17.9, respectively) and with less fatigue (-10.0 and -15.0, respectively) and pain (-16.3 for SMM gain). From the subscales that did show significantly different associations with SMM between the two treatment arms, we only found significant results in the observation arm. Here, associations were found for stable or gain in SMM with clinically relevant improved physical (12.4 for SMM gain), cognitive (10.7 and 9.7, respectively), and social functioning (15.5 and 15.6, respectively) as well as reduced appetite loss (-28.5 and -30.7, respectively).
CONCLUSIONS


In mCRC, SMM preservation during CAP-B and observation treatment is associated with significant and clinically relevant improvements in global health status and multiple functional and symptom scales. Studies are warranted to investigate whether interventions targeting SMM lead to improved HRQoL, fewer symptoms, and better functioning.",2020,"From the subscales that did show significantly different associations with SMM between the two treatment arms, we only found significant results in the observation arm.","['Of 221 patients included (mean age 63.5\xa0±\xa08.4\xa0years', 'metastatic colorectal cancer (mCRC) patients', 'mCRC patients in the CAIRO3 randomized clinical trial who were-after initial treatment-randomized between maintenance treatment with', 'patients with metastatic colorectal cancer']",['capecitabine plus bevacizumab (CAP-B'],"['mean global health status', 'HRQoL score', 'reduced appetite loss', 'global health status and multiple functional and symptom scales', 'social functioning', 'global health status', 'muscle mass and quality of life', 'Changes in SMM', 'fatigue', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0206034', 'cui_str': 'Clinical Trials, Randomized'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",221.0,0.148207,"From the subscales that did show significantly different associations with SMM between the two treatment arms, we only found significant results in the observation arm.","[{'ForeName': 'Jeroen W G', 'Initials': 'JWG', 'LastName': 'Derksen', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Sophie A', 'Initials': 'SA', 'LastName': 'Kurk', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Petra H M', 'Initials': 'PHM', 'LastName': 'Peeters', 'Affiliation': 'Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, GA, Utrecht, The Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Dorresteijn', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Jourdan', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.'}, {'ForeName': 'Ankie M T', 'Initials': 'AMT', 'LastName': 'van der Velden', 'Affiliation': 'Department of Medical Oncology, Tergooi Hospital, Hilversum, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nieboer', 'Affiliation': 'Department of Medical Oncology, Wilhemina Hospital, Assen, The Netherlands.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'de Jong', 'Affiliation': 'Department of Medical Oncology, Martini Hospital, Groningen, The Netherlands.'}, {'ForeName': 'Aafke H', 'Initials': 'AH', 'LastName': 'Honkoop', 'Affiliation': 'Department of Medical Oncology, Isala Hospital, Zwolle, The Netherlands.'}, {'ForeName': 'Cornelis J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'Department of Medical Oncology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Koopman', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, GA, Utrecht, The Netherlands.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12562']
3050,32096613,A randomized crossover trial of elamipretide in adults with primary mitochondrial myopathy.,"BACKGROUND


This study aims to evaluate the effect of subcutaneous (SC) elamipretide dosing on exercise performance using the 6 min walk test (6MWT), patient-reported outcomes measuring fatigue, functional assessments, and safety to guide the development of the Phase 3 trial.
METHODS


MMPOWER-2 was a randomized, double-blind, placebo-controlled, crossover trial that enrolled participants (N = 30) with genetically confirmed primary mitochondrial myopathy. Participants were randomly assigned (1:1) to 40 mg/day SC elamipretide for 4 weeks followed by placebo SC for 4 weeks, separated by a 4-week washout period, or the opposite sequence. The primary endpoint was the distance walked on the 6MWT.
RESULTS


The distance walked on the 6MWT by the elamipretide-treated participants was 398.3 (±134.16) meters compared with 378.5 (±125.10) meters in the placebo-treated group, a difference of 19.8 m (95% confidence interval, -2.8, 42.5; P = 0.0833). The results of the Primary Mitochondrial Myopathy Symptom Assessment Total Fatigue and Total Fatigue During Activities scores showed that participants treated with elamipretide reported less fatigue and muscle complaints compared with placebo (P = 0.0006 and P = 0.0018, respectively). Additionally, the Neuro-QoL Fatigue Short Form and Patient Global Assessment showed reductions in symptoms (P = 0.0115 and P = 0.0421, respectively). In this 4-week treatment period, no statistically significant change was observed in the Physician Global Assessment (P = 0.0636), the Triple Timed Up and Go (P = 0.8423) test, and wrist/hip accelerometry (P = 0.9345 and P = 0.7326, respectively). Injection site reactions were the most commonly reported adverse events with elamipretide (80%), the majority of which were mild. No serious adverse events or deaths were reported.
CONCLUSIONS


Participants who received a short-course treatment of daily SC elamipretide for 4 weeks experienced a clinically meaningful change in the 6MWT, which did not achieve statistical significance as the primary endpoint of the study. Secondary endpoints were suggestive of an elamipretide treatment effect compared with placebo. Nominal statistically significant and clinically meaningful improvements were seen in patient-reported outcomes. The results of this trial provided an efficacy signal and data to support the initiation of MMPOWER-3, a 6-month long, Phase 3 treatment trial in patients with primary mitochondrial myopathy.",2020,"During Activities scores showed that participants treated with elamipretide reported less fatigue and muscle complaints compared with placebo (P = 0.0006 and P = 0.0018, respectively).","['enrolled participants (N\xa0=\xa030) with genetically confirmed primary mitochondrial myopathy', 'patients with primary mitochondrial myopathy', 'adults with primary mitochondrial myopathy']","['placebo', 'placebo SC', 'elamipretide', 'subcutaneous (SC) elamipretide']","['Primary Mitochondrial Myopathy Symptom Assessment Total Fatigue and Total Fatigue', 'distance walked on the 6MWT', 'Physician Global Assessment', 'wrist/hip accelerometry', 'serious adverse events or deaths', 'fatigue and muscle complaints']","[{'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0162670', 'cui_str': 'Mitochondrial Myopathies'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4279623'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0162670', 'cui_str': 'Mitochondrial Myopathies'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}]",,0.522756,"During Activities scores showed that participants treated with elamipretide reported less fatigue and muscle complaints compared with placebo (P = 0.0006 and P = 0.0018, respectively).","[{'ForeName': 'Amel', 'Initials': 'A', 'LastName': 'Karaa', 'Affiliation': 'Genetics Unit, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haas', 'Affiliation': ""Rady Children's Hospital, UC San Diego School of Medicine, La Jolla, CA, USA.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Goldstein', 'Affiliation': ""Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Vockley', 'Affiliation': ""Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, PA, USA.""}, {'ForeName': 'Bruce H', 'Initials': 'BH', 'LastName': 'Cohen', 'Affiliation': ""Department of Pediatrics, Rebecca D. Considine Research Institute, Akron Children's Hospital, Akron, OH, USA.""}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12559']
3051,31389909,Effects of Exercise Training and Statin Use in People Living with HIV with Dyslipidemia.,"PURPOSE


To evaluate the effects of the combination of ET and statins in people living with HIV.
METHODS


This was a randomized, double-blind, placebo-controlled clinical trial. Eighty-three people living with HIV were assigned to either placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET) groups. Volunteers assigned to STA and STAET groups were administered 10 mg of rosuvastatin, whereas the PL and PLET groups were administered a placebo. PLET and STAET groups performed ET three times a week. Before and after the 12-week follow-up, the volunteers underwent to anthropometric assessment and blood collection to evaluate lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests were performed.
RESULTS


There was a decrease in total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT) in the STA, PLET, and STAET groups compared to PL group (p<0.001). Furthermore, there was a decrease in TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels in the STAET groups compared to the STA (p<0.001) and PLET groups (p<0.001). There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001). The PLET and STAET groups reduced body fat mass, body fat percentage and increased lean body mass, MS and CF compared to PL (p<0.001) and STA (p<0.001) groups.
CONCLUSION


The combination of ET and statins is useful to enhance lipid and inflammatory profiles, reduce CVD markers, and improve Doppler ultrasound findings, MS and CF in people living with HIV.",2019,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","['people living with HIV', 'People Living with HIV with Dyslipidemia', 'Eighty-three people living with HIV']","['STA', 'placebo (PL), statins (STA), placebo + ET (PLET) or statins + ET (STAET', 'rosuvastatin', 'Exercise Training and Statin Use', 'placebo', 'PLET', 'ET and statins']","['TC, TG, LDL, IL-1β, IL-6, and IL-8 levels and in left and right cIMT and an increase in HDL-c levels', 'lipid profile, cardiovascular markers, inflammatory profile; a Doppler ultrasound examination, muscle strength (MS) and cardiorespiratory fitness (CF) tests', 'IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate', 'body fat mass, body fat percentage and increased lean body mass, MS and CF', 'total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL-c), C-reactive protein, fibrinogen, interleukin (IL)-1β and right carotid intima-media thickness (cIMT']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemias'}, {'cui': 'C4517888', 'cui_str': '83'}]","[{'cui': 'C1529286', 'cui_str': 'stas'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0442710', 'cui_str': 'Peak systolic, function (observable entity)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}]",83.0,0.0940275,"There was an increase in IL-10 levels, peak-systolic velocity, end-diastolic velocity, wall shear rate in the PLET and STAET groups compared to the PL (p<0.001) and STA groups (p<0.001).","[{'ForeName': 'Hugo Ribeiro', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Gonçalves', 'Affiliation': 'Master Institute of Education President Antônio Carlos, Araguari/MG, Brazil.'}, {'ForeName': 'Leandro Teixeira', 'Initials': 'LT', 'LastName': 'Paranhos Lopes', 'Affiliation': 'Brazil University, Fernandópolis/SP, Brazil.'}, {'ForeName': 'Edmar Lacerda', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Institute of Health Sciences, Department of Sport Sciences, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Roever', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}, {'ForeName': 'Mário Leon', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Fernando Freitas', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Institute of Health Sciences, Department of Medical Clinics, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba/MG, Brazil.'}, {'ForeName': 'Elmiro Santos', 'Initials': 'ES', 'LastName': 'Resende', 'Affiliation': 'Postgraduate Program in Health Science, Faculty of Medicine, Federal University of Uberlândia, Uberlândia/MG, Brazil.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002120']
3052,32097391,Effect of polyethylene glycol versus lactulose on abdominal pain in children occult constipation: a randomized controlled study.,"INTRODUCTION AND AIM


Functional abdominal pain (FAP) is one of the major gastrointestinal complaints in childhood. Studies have reported occult constipation (OC) as one of the leading causes of abdominal pain. Recent researches have proposed laxatives as potent therapeutic targets for abdominal pain in patients with OC. However, no study has compared effect of poly ethylene glycol (PEG) and lactulose on occult constipation.
MATERIALS AND METHODS


51 patients aged 4 to 18 years with abdominal pain who had OC (defined as fecal impaction in abdominal X ray) were studied. Demographic and clinical data including age, sex, body weight, height, abdominal pain duration, abdominal pain rate and fecal odor were registered. They were randomly assigned to receive PEG (1gr/kg) or Lactulose (1cc/kg) for at least two weeks. All patients were reevaluated by pain measurement scale after at least two weeks of treatment.
RESULTS


It is indicated that the efficacy of PEG for reducing abdominal pain in OC was 48% while it was 37% for Lactulose. This study indicated that this efficacy is not affected significantly by sex and fecal odor, however this efficacy is influenced by age, body weight, abdominal pain duration and abdominal pain rate for both PEG and Lactulose.
CONCLUSION


It could be concluded that PEG is a more efficient drug for treating abdominal pain in occult constipation than Lactulose and its optimum effect can be achieved in elder patients with more severe abdominal pain.",2019,"This study indicated that this efficacy is not affected significantly by sex and fecal odor, however this efficacy is influenced by age, body weight, abdominal pain duration and abdominal pain rate for both PEG and Lactulose.
","['children occult constipation', 'patients with OC', 'elder patients with more severe abdominal pain', '51 patients aged 4 to 18 years with abdominal pain who had OC (defined as fecal impaction in abdominal X ray']","['polyethylene glycol versus lactulose', 'poly ethylene glycol (PEG) and lactulose', 'Lactulose', 'PEG']","['body weight, abdominal pain duration and abdominal pain rate', 'Demographic and clinical data including age, sex, body weight, height, abdominal pain duration, abdominal pain rate and fecal odor', 'pain measurement scale', 'abdominal pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205262', 'cui_str': 'Occult (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0331055', 'cui_str': 'Elder Plant'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0015734', 'cui_str': 'Fecal Impaction'}, {'cui': 'C0034573', 'cui_str': 'Radiography, Abdominal'}]","[{'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0015086', 'cui_str': 'Dihydroxyethanes'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0028884', 'cui_str': 'Odors'}, {'cui': 'C0030198', 'cui_str': 'Nociception Tests'}, {'cui': 'C0222045'}]",51.0,0.083618,"This study indicated that this efficacy is not affected significantly by sex and fecal odor, however this efficacy is influenced by age, body weight, abdominal pain duration and abdominal pain rate for both PEG and Lactulose.
","[{'ForeName': 'Mehran', 'Initials': 'M', 'LastName': 'Hakimzadeh', 'Affiliation': ""Dept. of Pediatric Gastroenterology, Abuzar Children's Hospital, Ahvaz Jundishapur University of Medical Sciences. Ahvaz, Iran.""}, {'ForeName': 'Sayeh', 'Initials': 'S', 'LastName': 'Mottaghi', 'Affiliation': ""Dept. of Pediatric Gastroenterology, Abuzar Children's Hospital, Ahvaz Jundishapur University of Medical Sciences. Ahvaz, Iran.""}, {'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Ahmadi', 'Affiliation': ""Dept. of Pediatric Gastroenterology, Abuzar Children's Hospital, Ahvaz Jundishapur University of Medical Sciences. Ahvaz, Iran.""}, {'ForeName': 'Hazhir', 'Initials': 'H', 'LastName': 'Javaherizadeh', 'Affiliation': ""Dept. of Pediatric Gastroenterology, Abuzar Children's Hospital, Ahvaz Jundishapur University of Medical Sciences. Ahvaz, Iran; Alimentary Tract Research Center, Ahvaz Jundishapur University of Medical Sciences. Ahvaz, Iran.""}]",Revista de gastroenterologia del Peru : organo oficial de la Sociedad de Gastroenterologia del Peru,[]
3053,31385918,REAL-WORLD EFFECTIVENESS AND SAFETY OF RANIBIZUMAB TREATMENT IN PATIENTS WITH AND WITHOUT POLYPOIDAL CHOROIDAL VASCULOPATHY: Twelve-Month Results From the LUMINOUS Study.,"PURPOSE


To evaluate the real-world effectiveness and safety of intravitreal ranibizumab 0.5 mg in treatment-naive patients with and without polypoidal choroidal vasculopathy (PCV).
METHODS


Assessment of neovascular age-related macular degeneration patients with or without PCV after 12 months of ranibizumab treatment during the LUMINOUS study. Outcome measures were visual acuity and central retinal thickness changes from baseline and the rate of ocular adverse events.
RESULTS


At baseline, 572 and 5,644 patients were diagnosed with and without PCV, respectively. The mean visual acuity gain from baseline at Month 12 in the PCV and non-PCV groups was +5.0 and +3.0 letters, respectively; these gains were achieved with a mean of 4.4 and 5.1 ranibizumab injections. Eighty percent of PCV patients and 72.2% of non-PCV patients who had baseline visual acuity ≥73 letters maintained this level of vision at Month 12; 20.6% and 17.9% of patients with baseline visual acuity <73 letters achieved visual acuity ≥73 letters in these groups. Greater reductions in central retinal thickness from baseline were also observed for the PCV group versus the non-PCV group. The rate of serious ocular adverse events was 0.7% (PCV group) and 0.9% (non-PCV group).
CONCLUSION


LUMINOUS confirms the effectiveness and safety of ranibizumab in treatment-naive patients with PCV.",2020,Greater reductions in central retinal thickness from baseline were also observed for the PCV group versus the non-PCV group.,"['treatment-naive patients with and without polypoidal choroidal vasculopathy (PCV', 'treatment-naive patients with PCV', 'neovascular age-related macular degeneration patients with or without PCV after 12 months of ranibizumab treatment during the LUMINOUS study']","['VASCULOPATHY', 'intravitreal ranibizumab', 'ranibizumab']","['baseline visual acuity ≥73 letters maintained this level of vision', 'effectiveness and safety', 'central retinal thickness', 'visual acuity and central retinal thickness changes from baseline and the rate of ocular adverse events', 'visual acuity ≥73 letters', 'baseline visual acuity', 'mean visual acuity gain', 'rate of serious ocular adverse events']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1504336', 'cui_str': 'Polypoidal choroidal vasculopathy'}, {'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}, {'cui': 'C0271084', 'cui_str': 'Neovascular age-related macular degeneration'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}]","[{'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.177222,Greater reductions in central retinal thickness from baseline were also observed for the PCV group versus the non-PCV group.,"[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Koh', 'Affiliation': 'Eye and Retina Surgeons, Camden Medical Centre, Singapore, Singapore.'}, {'ForeName': 'Timothy Y Y', 'Initials': 'TYY', 'LastName': 'Lai', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Wen Bin', 'Initials': 'WB', 'LastName': 'Wei', 'Affiliation': 'Beijing Ophthalmology and Visual Science Key Lab, Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Ryusaburo', 'Initials': 'R', 'LastName': 'Mori', 'Affiliation': 'Department of Ophthalmology, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Harumi', 'Initials': 'H', 'LastName': 'Wakiyama', 'Affiliation': 'The Japanese Red Cross Nagasaki Genbaku Hospital, Nagasaki, Japan.'}, {'ForeName': 'Kyu Hyung', 'Initials': 'KH', 'LastName': 'Park', 'Affiliation': 'Department of Ophthalmology, Seoul National University Bundang Hospital, Seoul National University, College of Medicine, Kyeonggi, Republic of Korea.'}, {'ForeName': 'Fariza', 'Initials': 'F', 'LastName': 'Ngah', 'Affiliation': 'Department of Ophthalmology, Hospital Selayang, Lebuhraya Selayang-Kepong, Batu Caves, Selangor, Malaysia.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Macfadden', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Dunger-Baldauf', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Soumil', 'Initials': 'S', 'LastName': 'Parikh', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002624']
3054,31556542,A multimodal training with visual biofeedback in subacute stroke survivors: a randomized controlled trial.,"BACKGROUND


Early interventions maximizing patient's involvement are essential to promote gait restoration and motor recovery after stroke.
AIM


The aim of this study is to evaluate the effects of a multimodal biofeedback training involving cycling augmented by functional electrical stimulation (FES) and balance exercises on walking ability and motor recovery.
DESIGN


Randomized controlled trial (NCT02439515).
SETTING


Inpatient rehabilitation facility.
POPULATION


Subacute stroke survivors (less than 6 months from the first event) aged up to 90 years old.
METHODS


Sixty-eight participants were randomly allocated to an experimental group, performing 15 sessions of biofeedback FES-cycling training followed by 15 sessions of biofeedback balance training (20 minutes each) in addition to usual care (70 minutes), and a control group performing 30 sessions (90 minutes) of usual care. Participants were evaluated before training, after 15 sessions, after 30 sessions, and at 6-month follow-up through: gait speed (primary outcome), spatiotemporal gait parameters, Six-Minute Walking Test, Functional Independence Measure, Motricity Index, Trunk Control Test, Berg Balance Scale, and Fall Efficacy Scale.
RESULTS


Both groups significantly improved over time, but no group and interaction effects were found for any outcomes. The 73% of the experimental group achieved a clinically meaningful change in gait speed compared to the 38% of the control group (P=0.048). These percentages were even more unbalanced for patients with a moderate to severe gait impairment at baseline (91% versus 36%; P=0.008).
CONCLUSIONS


The multimodal biofeedback training was not statistically superior to usual care, showing only a positive trend in favor of the experimental group on locomotion recovery. Patients initially not able to walk might be the best candidates for such a training.
CLINICAL REHABILITATION IMPACT


The multimodal biofeedback training is a task-specific, repetitive and intensive training requiring a minimal supervision, which might result in a lower staff to patient ratio if organized in group sessions. Therefore, it can represent a good alternative for early stroke rehabilitation.",2020,The 73% of the experimental group achieved a clinically meaningful change in gait speed compared to the 38% of the control group (p-value=0.048).,"['68 participants', 'Subacute stroke survivors (less than 6 months from the first event) with an age of up to 90 years old', 'subacute stroke survivors']","['multimodal training with visual biofeedback', 'biofeedback FES-cycling training followed by 15 sessions of biofeedback balance training (20 minutes each) in addition to usual care (70 minutes), and a control group performing 30 sessions (90 minutes) of usual care', 'multimodal biofeedback training', 'multimodal biofeedback training involving cycling augmented by Functional Electrical Stimulation (FES) and balance exercises']","['locomotion recovery', 'severe gait impairment', 'walking ability and motor recovery', 'clinically meaningful change in gait speed', 'spatio-temporal gait parameters, Six Minute Walking Test, Functional Independence Measure, Motricity Index, Trunk Control Test, Berg Balance Scale, and Fall Efficacy Scale']","[{'cui': 'C0205365', 'cui_str': 'Subacute course'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0150219', 'cui_str': 'Balance exercises'}]","[{'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C0451322', 'cui_str': 'Motricity index (assessment scale)'}, {'cui': 'C0426971', 'cui_str': 'Trunk control (observable entity)'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0222045'}]",68.0,0.0288114,The 73% of the experimental group achieved a clinically meaningful change in gait speed compared to the 38% of the control group (p-value=0.048).,"[{'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Ambrosini', 'Affiliation': 'Neuroengineering and Medical Robotics Laboratory, Department of Electronics, Information Technology, and Bioengineering, Politecnico di Milano, Milan, Italy - emilia.ambrosini@polimi.it.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Peri', 'Affiliation': 'Rehabilitation Unit of Lissone Institute, Istituti Clinici Scientifici Maugeri IRCCS, Lissone, Monza e Brianza, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Nava', 'Affiliation': 'Rehabilitation Unit of Lissone Institute, Istituti Clinici Scientifici Maugeri IRCCS, Lissone, Monza e Brianza, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Longoni', 'Affiliation': 'Rehabilitation Unit of Lissone Institute, Istituti Clinici Scientifici Maugeri IRCCS, Lissone, Monza e Brianza, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Monticone', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Pedrocchi', 'Affiliation': 'Neuroengineering and Medical Robotics Laboratory, Department of Electronics, Information Technology, and Bioengineering, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Ferriero', 'Affiliation': 'Rehabilitation Unit of Lissone Institute, Istituti Clinici Scientifici Maugeri IRCCS, Lissone, Monza e Brianza, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Ferrante', 'Affiliation': 'Neuroengineering and Medical Robotics Laboratory, Department of Electronics, Information Technology, and Bioengineering, Politecnico di Milano, Milan, Italy.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.19.05847-7']
3055,31852749,Circulating microRNA after autologous bone marrow mononuclear cell (BM-MNC) injection in patients with ischemic stroke.,"Previous studies have shown the potential of microRNAs (miRNA) in the pathological process of stroke and functional recovery. Bone marrow mononuclear cell (BM-MNC) transplantation improves recovery in experimental models of ischemic stroke that might be related with miRNA modifications. However, its effect on circulating miRNA has not been described in patients with stroke. We aimed to evaluate the circulating levels of miRNAs after autologous BM-MNC transplantation in patients with stroke. We investigate the pattern of miRNA-133b and miRNA-34a expression in patients with ischemic stroke included in a multicenter randomized controlled phase IIb trial (http://www.clinicaltrials.gov; unique identifier: NCT02178657). Patients were randomized to 2 different doses of autologous intra-arterial BM-MNC injection (2×10 6 /kg or 5×10 6 /kg) or control group within the first 7 days after stroke onset. We evaluate plasma concentration of miRNA-113b and miRNA-34a at inclusion and 4, 7, and 90 days after treatment. Thirteen cases (8 with 2×10 6 /kg BM-MNC dose and 5 with 5×10 6 /kg dose) and 11 controls (BM-MNC non-treated) were consecutively included. Mean age was 64.1±12.3 with a mean National Institutes of Health Stroke Scale score at inclusion of 14.5. Basal levels of miRNA were similar in both groups. miR-34a-5p and miR-133b showed different expression patterns. There was a significant dose-dependent increase of miRNA-34a levels 4 days after BM-MNC injection (fold change 3.7, p<0.001), whereas miRNA-133b showed a significant increase in the low-dose BM-MNC group at 90 days. Intra-arterial BM-MNC transplantation in patients with ischemic stroke seems to modulate early circulating miRNA-34a levels, which have been related to precursor cell migration in stroke and smaller infarct volumes.",2020,"Intra-arterial BM-MNC transplantation in patients with ischemic stroke seems to modulate early circulating miRNA-34a levels, which have been related to precursor cell migration in stroke and smaller infarct volumes.","['Thirteen cases (8 with 2×10 6 /kg', 'patients with ischemic stroke', 'patients with stroke']","['Bone marrow mononuclear cell (BM-MNC) transplantation', 'Intra-arterial BM-MNC transplantation', 'miRNA-133b and miRNA-34a expression', 'Circulating microRNA after autologous bone marrow mononuclear cell (BM-MNC) injection', 'autologous BM-MNC transplantation', 'autologous intra-arterial BM-MNC injection']","['Basal levels of miRNA', 'Health Stroke Scale score', 'miRNA-34a levels']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]","[{'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0694634', 'cui_str': 'Intra-arterial (qualifier value)'}, {'cui': 'C1101610', 'cui_str': 'miRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C4055233', 'cui_str': 'Cell-Free MicroRNA'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1101610', 'cui_str': 'miRNA'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0527952,"Intra-arterial BM-MNC transplantation in patients with ischemic stroke seems to modulate early circulating miRNA-34a levels, which have been related to precursor cell migration in stroke and smaller infarct volumes.","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Mancha', 'Affiliation': 'Neurovascular Laboratory, Instituto de Biomedicina de Sevilla, Sevilla, Spain.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Escudero-Martinez', 'Affiliation': 'Neurovascular Laboratory, Instituto de Biomedicina de Sevilla, Sevilla, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Zapata-Arriaza', 'Affiliation': 'Interventional Neuroradiology, Virgen del Rocio University Hospital, Sevilla, Andalucía, Spain.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Vega-Salvatierra', 'Affiliation': 'Neurovascular Laboratory, Instituto de Biomedicina de Sevilla, Sevilla, Spain.'}, {'ForeName': 'Juan Antonio', 'Initials': 'JA', 'LastName': 'Cabezas', 'Affiliation': 'Neurology, Virgen del Rocio University Hospital, Sevilla, Andalucía, Spain.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Lebrato', 'Affiliation': 'Neurology, Virgen del Rocio University Hospital, Sevilla, Andalucía, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Pardo', 'Affiliation': 'Neurology, Virgen del Rocio University Hospital, Sevilla, Andalucía, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'De-La-Torre', 'Affiliation': 'Neurology, Virgen del Rocio University Hospital, Sevilla, Andalucía, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Zapata', 'Affiliation': 'Neurovascular Laboratory, Instituto de Biomedicina de Sevilla, Sevilla, Spain.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Escamilla', 'Affiliation': 'Hematology, Virgen del Rocio University Hospital, Sevilla, Andalucía, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Calderón-Cabrera', 'Affiliation': 'Hematology, Virgen del Rocio University Hospital, Sevilla, Andalucía, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Martín-Sánchez', 'Affiliation': 'Hematology, Virgen del Rocio University Hospital, Sevilla, Andalucía, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Valverde', 'Affiliation': 'Neurology, Reina Sofia University Hospital, Cordoba, Andalucía, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Aguera-Morales', 'Affiliation': 'Neurology, Reina Sofia University Hospital, Cordoba, Andalucía, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Herrera', 'Affiliation': 'Hematology, Reina Sofia University Hospital, Cordoba, Andalucía, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Delgado', 'Affiliation': 'Interventional Neuroradiology, Reina Sofia University Hospital, Cordoba, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Gamero', 'Affiliation': 'Neurology, Virgen Macarena University Hospital, Sevilla, Andalucía, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Pérez-Sánchez', 'Affiliation': 'Neurology, Virgen Macarena University Hospital, Sevilla, Andalucía, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Moya', 'Affiliation': 'Neurology, Hospital Universitario Puerta del Mar, Cadiz, Andalucía, Spain.'}, {'ForeName': 'Raúl', 'Initials': 'R', 'LastName': 'Espinosa', 'Affiliation': 'Neurology, Hospital Universitario Puerta del Mar, Cadiz, Andalucía, Spain.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Ortega-Quintanilla', 'Affiliation': 'Interventional Neuroradiology, Virgen del Rocio University Hospital, Sevilla, Andalucía, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Gutierrez-Jarrin', 'Affiliation': 'Interventional Neuroradiology, Virgen del Rocio University Hospital, Sevilla, Andalucía, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'González-García', 'Affiliation': 'Neurovascular Laboratory, Instituto de Biomedicina de Sevilla, Sevilla, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Montaner', 'Affiliation': 'Neurology, Virgen Macarena University Hospital, Sevilla, Andalucía, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Moniche', 'Affiliation': 'Neurovascular Laboratory, Instituto de Biomedicina de Sevilla, Sevilla, Spain pmoniche@gmail.com.'}]",Journal of investigative medicine : the official publication of the American Federation for Clinical Research,['10.1136/jim-2019-001161']
3056,32094516,Effects of hybrid-functional electrical stimulation (FES) rowing whole-body exercise on neurologic improvement in subacute spinal cord injury: secondary outcomes analysis of a randomized controlled trial.,"STUDY DESIGN


Secondary outcome measures analysis of a randomized, controlled study.
OBJECTIVE


To assess the effects of hybrid-functional electrical stimulation (FES) rowing on motor and sensory recovery in individuals with spinal cord injury (SCI) 6-18 months post injury.
SETTING


Outpatient rehabilitation network.
METHODS


25 participants 6-12 months after SCI were randomly assigned to hybrid-FES rowing (n = 10) or standard of care (n = 15) groups. The hybrid-FES rowing group completed 6 months of rowing scheduled 3 times per week for 26 weeks at an exercise intensity of 70-85% of maximal heart rate. The standard of care group either participated in an arm ergometer exercise program (n = 6) or a waitlist without an explicit exercise program (n = 9). Changes in motor score and combined sensory score of the International Standards for Neurological Classification of SCI (ISNCSCI) were analyzed.
RESULTS


Both groups demonstrated increases in motor and combined sensory scores, but no significant differences were noted between intervention groups (motor difference mean ↑1.3 (95% CI, -1.9 to 4.4), combined sensory difference mean ↓10 (-30 to 18)). There was an average of 63% adherence to the hybrid-FES rowing protocol, with no significant correlation in changes in motor or combined sensory score in the hybrid-FES rowing group with total distance or time rowed.
CONCLUSIONS


No significant effects to neurologic improvement were found with hybrid-FES rowing when compared with standard of care interventions in individuals with SCI 6-18 months post injury.",2020,No significant effects to neurologic improvement were found with hybrid-FES rowing when compared with standard of care interventions in individuals with SCI 6-18 months post injury.,"['individuals with spinal cord injury (SCI) 6-18 months post injury', '25 participants 6-12 months after SCI', 'Outpatient rehabilitation network', 'subacute spinal cord injury']","['hybrid-FES rowing', 'hybrid-functional electrical stimulation (FES) rowing', 'hybrid-FES rowing (n\u2009=\u200910) or standard of care', 'hybrid-functional electrical stimulation (FES) rowing whole-body exercise', 'care group either participated in an arm ergometer exercise program (n\u2009=\u20096) or a waitlist without an explicit exercise program']","['motor score and combined sensory score', 'motor and combined sensory scores', 'motor or combined sensory score', 'neurologic improvement']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205365', 'cui_str': 'Subacute course'}]","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C4505111', 'cui_str': 'Rowing'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}]",25.0,0.116675,No significant effects to neurologic improvement were found with hybrid-FES rowing when compared with standard of care interventions in individuals with SCI 6-18 months post injury.,"[{'ForeName': 'Raymond C', 'Initials': 'RC', 'LastName': 'Chou', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA. rchou1@partners.org.'}, {'ForeName': 'J Andrew', 'Initials': 'JA', 'LastName': 'Taylor', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Solinsky', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Harvard Medical School, Boston, MA, USA.'}]",Spinal cord,['10.1038/s41393-020-0445-3']
3057,32056537,Sleep intervention for children with asthma and their parents (SKIP Study): a novel web-based shared management pilot study.,"STUDY OBJECTIVES


The objective of this study was to describe the feasibility, acceptability, and preliminary efficacy of a novel Sleep Intervention for Kids and Parents (SKIP). Parent and child primary sleep outcomes were total sleep time, wake after sleep onset (WASO), sleep efficiency (SE), and bedtime range.
METHODS


Children 6-11 years of age with asthma and 1 parent, both with behavioral sleep disturbance, enrolled in this single-group pilot. The 8-week shared management intervention included weekly online educational modules, goal setting, and progress reporting. Feasibility was measured by the number of dyads who were eligible, enrolled, and retained. Acceptability was measured by survey and semistructured interview. Total sleep time, WASO, SE, and bedtime range were measured by actigraphy at baseline, after the intervention, and 12-week follow-up. Mixed-effects regression models were used to determine change in sleep outcomes from baseline.
RESULTS


Thirty-three of 39 eligible dyads enrolled; of 29 dyads that started the intervention, 25 (86%) completed all study visits. SKIP was acceptable for 61% of children and 92% of parents. Compared with baseline, at follow-up, children had significantly improved WASO (-37 minutes; 95% confidence interval [CI], -44.5 to -29.7; P < .001), SE (5.4%; 95% CI, 4.2-6.5; P < .001), and bedtime range (-35.2 minutes; 95% CI, -42.9 to -27.5; P < .001). Parents also had significantly improved WASO (-13.9 minutes; 95% CI, -19.5 to -8.2; P < .001), SE (2.7%; 95% CI, 1.7-.7; P < .001), and bedtime range (-35.3 minutes; 95% CI, -51.0 to -19.7; P < .001).
CONCLUSIONS


SKIP was feasible, acceptable, and we observed improved child and parent sleep outcomes except total sleep time. Following refinements, further testing of SKIP in a controlled clinical trial is warranted. Clinical Trial Registration: Registry: ClinicalTrials.gov; Name: Sleep Intervention for Kids and Parents: A Self-Management Pilot Study; URL: https://www.clinicaltrials.gov/ct2/show/study/NCT03144531; Identifier: NCT03144531.",2020,"Parents also had significantly improved WASO (-13.9 min [-19.5 to -8.2], p<.001), SE (2.7% [1.7 to 3.7], p<.001), and bedtime range (-35.3 min [-51.0 to -19.7], p<.001).
","['Thirty-three out of 39 eligible dyads enrolled; of 29 dyads that started the intervention, 25 (86%) completed all study visits', 'Children aged 6-11 years with asthma and one parent, both with behavioral sleep disturbance, enrolled in this single-group pilot', 'Kids and Parents (SKIP', 'Children with Asthma and their Parents (SKIP']","['Sleep Intervention', 'novel Sleep Intervention']","['Acceptability', 'WASO', 'total sleep time (TST), wake after sleep onset (WASO), sleep efficiency (SE), and bedtime range', 'TST, WASO, SE and bedtime range']","[{'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0560435', 'cui_str': 'Does skip (finding)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]",39.0,0.0932582,"Parents also had significantly improved WASO (-13.9 min [-19.5 to -8.2], p<.001), SE (2.7% [1.7 to 3.7], p<.001), and bedtime range (-35.3 min [-51.0 to -19.7], p<.001).
","[{'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Sonney', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, University of Washington School of Nursing, Seattle, Washington.'}, {'ForeName': 'Hilaire J', 'Initials': 'HJ', 'LastName': 'Thompson', 'Affiliation': 'Department of Biobehavioral Nursing and Health Informatics, University of Washington School of Nursing, Seattle, Washington.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Landis', 'Affiliation': 'Department of Biobehavioral Nursing and Health Informatics, University of Washington School of Nursing, Seattle, Washington.'}, {'ForeName': 'Kenneth C', 'Initials': 'KC', 'LastName': 'Pike', 'Affiliation': 'Office of Nursing Research, University of Washington School of Nursing, Seattle, Washington.'}, {'ForeName': 'Maida L', 'Initials': 'ML', 'LastName': 'Chen', 'Affiliation': ""Pulmonary and Sleep Medicine, Seattle Children's Hospital, Seattle, Washington.""}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'Garrison', 'Affiliation': 'Department of Health Services, University of Washington School of Public Health, Division of Child and Adolescent Psychiatry, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Ward', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, University of Washington School of Nursing, Seattle, Washington.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8374']
3058,32068323,Drinking and responses to antidrinking messages among young adults: An fMRI study.,"Young adults consume most of their alcohol by binge drinking, and more than one-third report binge drinking in the past month. Some will transition out of excessive drinking, while others will maintain or increase alcohol use into adulthood. Public health campaigns depicting negative consequences of drinking have shown some efficacy at reducing this behavior. However, substance use in dependent individuals is governed in part by automatic or habitual responses to drug cues rather than the consequences. This study used functional magnetic resonance imaging to measure neural responses to drinking cues and drinking cues paired with antidrinking messages among young adults who binge drink (N = 30). This study also explored responses to smoking cues and antismoking messages. Neural responses were also compared between drinking/smoking and neutral cues. Self-reported drinking and smoking were collected at baseline, postscan, and 1 month. Results indicate that activity in the ventral striatum-implicated in reward processing-was lower for drinking cues paired with antidrinking messages than drinking cues. This difference was less pronounced in young adults who reported greater baseline past month drinking quantity. Past month drinking quantity decreased from baseline to 1 month. Further, young adults who showed higher activity during antidrinking messages in the medial prefrontal cortex-implicated in processing message self-relevance- reported a greater decrease in past month drinking frequency from baseline to 1 month. Findings may help to identify young adults who are at risk for continued heavy drinking in adulthood and inform interventions aimed to reduce drinking and reward in young adults.",2020,Results indicate that activity in the ventral striatum-implicated in reward processing-was lower for drinking cues paired with antidrinking messages than drinking cues.,"['Young adults', 'young adults', 'young adults who are at risk for continued heavy drinking in adulthood', 'young adults who binge drink (N = 30']",['functional magnetic resonance imaging'],"['past month drinking frequency', 'Past month drinking quantity', 'Neural responses']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0700597', 'cui_str': 'Adulthood - period'}, {'cui': 'C0556346', 'cui_str': 'Binge Drinking'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}]",30.0,0.0139834,Results indicate that activity in the ventral striatum-implicated in reward processing-was lower for drinking cues paired with antidrinking messages than drinking cues.,"[{'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Garrison', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Kelly S', 'Initials': 'KS', 'LastName': 'DeMartini', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Philip R', 'Initials': 'PR', 'LastName': 'Corlett', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'Worhunsky', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT.'}]",Addiction biology,['10.1111/adb.12882']
3059,31489810,Preoperative respiratory muscle endurance training improves ventilatory capacity and prevents pulmonary postoperative complications after lung surgery.,"BACKGROUND


Resection surgery is the main treatment for non-small cell lung cancer (NSCLC). Postoperative complications and mortality are mostly linked to respiratory failure consecutive to respiratory muscle overload.
AIM


We aimed to evaluate the effect of preoperative respiratory muscle endurance training (RMET) on respiratory muscle capacity and postoperative complications in patients undergoing NSCLC resection.
DESIGN


Randomized controlled trial.
SETTING


French university hospital.
POPULATION


Patients eligible for NSCLC resection.
METHODS


The training group (T group) performed a 3-week preoperative RMET added to usual chest physical therapy while the control group (C group) had only the latter. The primary outcome was the change in respiratory muscle endurance. Secondary outcomes were postoperative complications and mortality. Assessments were performed similarly at baseline and after the intervention. We conducted multivariable analyses with analysis of covariance (ANCOVA) taking into account baseline values for isocapnic hyperpnoea endurance test, exercise capacity and pulmonary function tests. The number of pulmonary postoperative complication was analyzed by Fisher-exact test.
RESULTS


We included 26 patients with NSCLC (14 in the T group and 12 in the C group). Respiratory muscle endurance significantly increased in the T group after the RMET compared with C group (+229±199 vs. -5±371 sec, P=0.001). This increase was associated with a significantly lower number of pulmonary postoperative complications (2 vs. 10, P=0.037).
CONCLUSIONS


Preoperative RMET improved respiratory muscle endurance and decreased pulmonary postoperative complications after surgery for NSCLC. These positive results obtained after RMET may help improve the perioperative course for such patients. These results should be confirmed in larger randomized controlled trials, including higher number of patients especially with altered respiratory muscle function.
CLINICAL REHABILITATION IMPACT


Low-cost and easy to perform, RMET training could serve as complementary tool to usual chest physical therapy, before lung resection surgery.",2020,"Respiratory muscle endurance significantly increased in the T group after the RMET compared with C group (+229±199 vs. -5±371 sec, p=0.001).","['patients undergoing NSCLC resection', 'French university hospital', '26 patients with NSCLC', 'Patients eligible for NSCLC resection', 'after lung surgery']","['preoperative respiratory muscle endurance training (RMET', 'preoperative RMET added to usual chest physical therapy', 'Resection surgery', 'Preoperative respiratory muscle endurance training']","['number of pulmonary postoperative complication', 'respiratory muscle capacity and postoperative complications', 'change in respiratory muscle endurance', 'Respiratory muscle endurance', 'respiratory muscle endurance', 'postoperative complications and mortality', 'ventilatory capacity', 'pulmonary postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",26.0,0.0917245,"Respiratory muscle endurance significantly increased in the T group after the RMET compared with C group (+229±199 vs. -5±371 sec, p=0.001).","[{'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Laurent', 'Affiliation': 'Clermont Auvergne University, Clermont-Ferrand, France - hlaurent@chu-clermontferrand.fr.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Aubreton', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Géraud', 'Initials': 'G', 'LastName': 'Galvaing', 'Affiliation': 'Department of Thoracic and Endocrinological Surgery, Center Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': ""CHU Clermont-Ferrand, Délégation à la Recherche Clinique et à l'Innovation (DRCI), Clermont-Ferrand, France.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': 'Department of Pneumology, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Ruddy', 'Initials': 'R', 'LastName': 'Richard', 'Affiliation': 'Clermont Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Costes', 'Affiliation': 'Clermont Auvergne University, Clermont-Ferrand, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Filaire', 'Affiliation': 'Clermont Auvergne University, Clermont-Ferrand, France.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.19.05781-2']
3060,32088664,The Effects Of Slow Breathing Exercise On Heart Rate Dynamics And Cardiorespiratory Coherence In Preschool Children: A Prospective Clinical Study.,"Background


Slow breathing has been used to improve psychophysiological regulation due to positive action on the autonomic nervous system.
Primary Study Objective


We evaluated the effects of slow breathing on heart rate autonomic control in preschool-aged children.
Methods/Design


Prospective clinical study.
Setting


Campinas, Brazil.
Participants


We included 42 children in the experimental group (age 5.7 ± 0.3) and 33 children in the control group (age 6.2 ± 0.3).
Intervention


Children received a daily training of eight weeks duration for practicing a slow breathing technique. Primary Outcome Measures • We analyzed heart rate variability (HRV) and cardiorespiratory coherence at rest under spontaneous breathing and during respiratory sinus arrhythmia (RSA) at the end of the 1st, 4th, and 8th weeks of training.
Results


The percentage of high coherence ratio increased (P < .0001), HRV reduced (SDNN, P = .0066; RMSSD, P = .0015; pNN50, P < .0001; SD1, P = .0015; SD2, P = .0166) and the complexity of HRV increased (ApEn, P = .0004; MSE area, P < .0001; DFAαl, P = .0001; ShanEnt, P = .0106; Lmean, P = .0066) during RSA compared to spontaneous breathing after slow breathing training period.
Conclusion


Slow breathing training exercise induced increased cardiorespiratory coherence and increased nonlinear behavior of heart rate dynamics suggesting improvements in health status. Increased cardiorespiratory coherence reinforces the importance of including respiratory exercises in strategies that aim to promote physical health and self-regulation skills in educational settings.",2020,"The percentage of high coherence ratio increased (P < .0001), HRV reduced (SDNN, P = .0066; RMSSD, P = .0015; pNN50, P < .0001; SD1, P = .0015; SD2, P = .0166) and the complexity of HRV increased (ApEn, P = .0004; MSE area, P < .0001; DFAαl, P = .0001;","['Participants\n\n\nWe included 42 children in the experimental group (age 5.7 ± 0.3) and 33 children in the control group (age 6.2 ± 0.3', 'preschool-aged children', 'Preschool Children']","['Slow Breathing Exercise', 'daily training of eight weeks duration for practicing a slow breathing technique', 'Slow breathing training exercise', 'slow breathing']","['heart rate variability (HRV) and cardiorespiratory coherence at rest under spontaneous breathing and during respiratory sinus arrhythmia (RSA', 'heart rate autonomic control', 'HRV', 'Heart Rate Dynamics And Cardiorespiratory Coherence', 'percentage of high coherence ratio', 'cardiorespiratory coherence', 'complexity of HRV']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517795', 'cui_str': 'Five point seven'}, {'cui': 'C4068885', 'cui_str': 'Zero point three'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}]","[{'cui': 'C0231837', 'cui_str': 'Slow respiration (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C3812870', 'cui_str': 'Respiratory Sinus Arrhythmia'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",42.0,0.0420492,"The percentage of high coherence ratio increased (P < .0001), HRV reduced (SDNN, P = .0066; RMSSD, P = .0015; pNN50, P < .0001; SD1, P = .0015; SD2, P = .0166) and the complexity of HRV increased (ApEn, P = .0004; MSE area, P < .0001; DFAαl, P = .0001;","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Zuanazzi Cruz', 'Affiliation': ''}, {'ForeName': 'Moacir', 'Initials': 'M', 'LastName': 'Fernandes de Godoy', 'Affiliation': ''}, {'ForeName': 'Vitor E', 'Initials': 'VE', 'LastName': 'Valenti', 'Affiliation': ''}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Pereira', 'Affiliation': ''}, {'ForeName': 'Roberto Antonio', 'Initials': 'RA', 'LastName': 'Dias Cardoso', 'Affiliation': ''}]",Alternative therapies in health and medicine,[]
3061,31739708,tDCS-Enhanced Consolidation of Writing Skills and Its Associations With Cortical Excitability in Parkinson Disease: A Pilot Study.,"Background . Learning processes of writing skills involve the re-engagement of previously established motor programs affected by Parkinson disease (PD). To counteract the known problems with consolidation in PD, transcranial direct current stimulation (tDCS) could be imperative to achieve a lasting regeneration of habitual motor skills.  Objective . To examine tDCS-enhanced learning of writing and explore alterations in cortical excitability after stimulation in PD compared with healthy controls (HCs).  Methods . Ten patients and 10 HCs received 2 training sessions combined with 20 minutes of 1-mA anodal tDCS or sham on the left primary motor cortex in a randomized crossover design. Writing skills on a tablet and paper were assessed at baseline, after training, and after 1 week of follow-up. Before and immediately after the intervention, cortical excitability and inhibition were measured during rest and activity.  Results . Writing amplitude and velocity improved when practice was tDCS supplemented compared with sham in PD. Benefits were sustained at retention for trained and untrained tasks on the tablet as well as for writing on paper. No improvements were found for HCs. Reduced resting motor thresholds after tDCS indicated tDCS-enhanced cortical excitability. Additionally, increments in motor-evoked potential amplitudes correlated with improved writing in PD, whereas HCs showed the opposite pattern.  Conclusion . Our results endorse the usefulness of tDCS-boosted learning in PD, at least when applied to improving writing capacity. Although further confirmatory studies are needed, these novel findings are striking because tDCS-mediated consolidation was found for learning a motor task directly affected by PD.",2019,"Additionally, increments in motor-evoked potential amplitudes correlated with improved writing in PD, whereas HCs showed the opposite pattern.  ","['Ten patients and 10 HCs received 2', 'Parkinson Disease']","['tDCS-Enhanced Consolidation of Writing Skills', 'transcranial direct current stimulation (tDCS', 'training sessions combined with 20 minutes of 1-mA anodal tDCS or sham on the left primary motor cortex']","['Writing amplitude and velocity', 'cortical excitability', 'cortical excitability and inhibition', 'HCs', 'motor-evoked potential amplitudes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1172076', 'cui_str': '1-(PE)-MA'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}]","[{'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0282617', 'cui_str': 'Evoked Potentials, Motor'}]",,0.086135,"Additionally, increments in motor-evoked potential amplitudes correlated with improved writing in PD, whereas HCs showed the opposite pattern.  ","[{'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Broeder', 'Affiliation': 'KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Nackaerts', 'Affiliation': 'KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Cuypers', 'Affiliation': 'KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Raf', 'Initials': 'R', 'LastName': 'Meesen', 'Affiliation': 'KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Verheyden', 'Affiliation': 'KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Nieuwboer', 'Affiliation': 'KU Leuven, Leuven, Belgium.'}]",Neurorehabilitation and neural repair,['10.1177/1545968319887684']
3062,31916418,Effect of Food on the Pharmacokinetics of Quizartinib.,"Quizartinib is an oral, highly potent, and selective type II FMS-like tyrosine kinase 3 inhibitor in development for acute myeloid leukemia. This parallel-group study evaluated potential food effects on quizartinib absorption in healthy subjects who received a single 30-mg dose after overnight fasting (n = 34) or a high-fat, high-calorie meal (n = 30). Blood samples were collected through 504 hours after dosing, and pharmacokinetic parameters calculated were maximum observed concentration (C max  ) and area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUC last  ) and from time 0 to infinity (AUC inf  ). Mean quizartinib pharmacokinetic profiles were similar under fasted and fed conditions. The geometric least squares means ratios (%) for fed/fasted and associated 90% confidence intervals (CIs) for C max  , AUC last  , and AUC inf  were 91.58 (82.15-102.08), 105.39 (90.79-122.35), and 108.39 (91.54-128.34), respectively. The 90%CI for the ratio fell within the 80% to 125% limits for C max  and AUC last  , with 90%CI for AUC inf  slightly outside the limits (ie, 128%). Food delayed quizartinib time to C max  by 2 hours. All adverse events were either mild or moderate; no discontinuations due to adverse events occurred. Based on these results, quizartinib can be administered without regard to food.",2020,All adverse events were either mild or moderate; no discontinuations due to adverse events occurred.,['healthy subjects who received a single 30-mg dose after overnight fasting (n = 34) or a'],"['high-fat, high-calorie meal']","['Blood samples', 'Mean quizartinib pharmacokinetic profiles', 'concentration (C max  ) and area under plasma concentration-time curve from time 0 to last quantifiable concentration (AUC last  ) and from time 0 to infinity (AUC inf  ', 'quizartinib absorption']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2980091', 'cui_str': 'AC220 compound'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}]",504.0,0.01997,All adverse events were either mild or moderate; no discontinuations due to adverse events occurred.,"[{'ForeName': 'Jianke', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Formerly Daiichi Sankyo, Inc., San Diego, California, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Holmes', 'Affiliation': 'Formerly Daiichi Sankyo, Inc., San Diego, California, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kankam', 'Affiliation': 'Vince & Associates, Overland Park, Kansas, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Trone', 'Affiliation': 'Formerly Daiichi Sankyo, Inc., San Diego, California, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Mendell', 'Affiliation': 'Daiichi Sankyo, Inc, Basking Ridge, New Jersey, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Gammon', 'Affiliation': 'Formerly Daiichi Sankyo, Inc., San Diego, California, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.770']
3063,32089359,Radical Prostatectomy or Observation for Clinically Localized Prostate Cancer: Extended Follow-up of the Prostate Cancer Intervention Versus Observation Trial (PIVOT).,"BACKGROUND


Very long-term mortality in men with early prostate cancer treated with surgery versus observation is uncertain.
OBJECTIVE


To determine long-term effects of surgery versus observation on all-cause mortality for men with early prostate cancer.
DESIGN, SETTING, AND PARTICIPANTS


This study evaluated long-term follow-up of a randomized trial conducted at the US Department of Veterans Affairs and National Cancer Institute sites. The participants were men (n=731) ≤75yr of age with localized prostate cancer, prostate-specific antigen (PSA) <50ng/ml, life expectancy ≥10yr, and medically fit for surgery.
INTERVENTION


Radical prostatectomy versus observation.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


All-cause mortality was assessed in the entire cohort and patient and tumor subgroups. Intention-to-treat analysis was conducted using Kaplan-Meier methods with log-rank tests and Cox proportional hazard models; cumulative mortality incidence, between-group differences, and relative risks were also assessed at predefined time periods.
RESULTS AND LIMITATIONS


During 22.1yr (median follow-up for survivors=18.6yr; interquartile range: 16.6-20.0), 515 men died; 246 of 346 men (68%) were assigned to surgery versus 269 of 367 (73%) assigned to observation (hazard ratio 0.84 [95% confidence interval {CI}: 0.70-1.00]; p= 0.044 [absolute risk reduction = 5.7 percentage points, 95% CI: -0.89 to 12%]; relative risk: 0.92 [95% CI: 0.84-1.01]). The restricted mean survival in the surgical group was 13.6 yr (95% CI: 12.9-14.3) versus 12.6 yr (95% CI: 11.8-13.3) in the observation group; a mean of 1 life-year was gained with surgery. Results did not significantly vary by patient or tumor characteristics, although differences were larger favoring surgery among men aged <65 yr, of white race, and having better health status, fewer comorbidities, ≥34% positive prostate biopsy cores, and intermediate-risk disease. Results were not adjusted for multiple comparisons, and we could not assess outcomes other than all-cause mortality.
CONCLUSIONS


Surgery was associated with small very long-term reductions in all-cause mortality and increases in years of life gained. Absolute effects did not vary markedly by patient characteristics. Absolute effects and mean survival were much smaller in men with low-risk disease, but were greater in men with intermediate-risk disease although not in men with high-risk disease.
PATIENT SUMMARY


In this randomized study, we evaluated death from any cause in men with early prostate cancer treated with either surgery or observation. Overall, surgery may provide small very long-term reductions in death from any cause and increases in years of life gained. Absolute effects were much smaller in men with low-risk disease, but were greater in men with intermediate-risk disease although not in men with high-risk disease. Strategies are needed to identify men needing and benefitting from surgery while reducing ineffective treatment and overtreatment.",2020,"Results did not significantly vary by patient or tumor characteristics, although differences were larger favoring surgery among men aged <65 yr, of white race, and having better health status, fewer comorbidities, ≥34% positive prostate biopsy cores, and intermediate-risk disease.","['men with early prostate cancer', 'Veterans Affairs and National Cancer Institute sites', '50', 'men with early prostate cancer treated with either surgery or observation', 'participants were men (n\u202f=\u202f731) ≤75', 'Clinically Localized Prostate Cancer', 'yr of age with localized prostate cancer, prostate-specific antigen (PSA']","['Radical prostatectomy versus observation', 'Radical Prostatectomy or Observation']","['mean survival', 'Absolute effects and mean survival']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]","[{'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.16697,"Results did not significantly vary by patient or tumor characteristics, although differences were larger favoring surgery among men aged <65 yr, of white race, and having better health status, fewer comorbidities, ≥34% positive prostate biopsy cores, and intermediate-risk disease.","[{'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Wilt', 'Affiliation': 'Minneapolis VA Center for Care Delivery and Outcomes Research, Minneapolis, MN, USA; Section of General Medicine, University of Minnesota School of Medicine, Minneapolis MN, USA. Electronic address: Tim.wilt@va.gov.'}, {'ForeName': 'Tien N', 'Initials': 'TN', 'LastName': 'Vo', 'Affiliation': 'University of Minnesota School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Langsetmo', 'Affiliation': 'University of Minnesota School of Public Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Dahm', 'Affiliation': 'Minneapolis VA Section of Urology, Minneapolis MN, USA; Department of Urology, University of Minnesota, Minneapolis MN, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wheeler', 'Affiliation': 'Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Aronson', 'Affiliation': 'VA Medical Center, Greater Los Angeles Healthcare System, Los Angeles, CA, USA; Department of Urology, University of California at Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Cooperberg', 'Affiliation': 'Department of Urology, University of California at San Francisco, CA, USA; Department of Urology and Epidemiology and Biostatistics, University of California at San Francisco, CA, USA.'}, {'ForeName': 'Brent C', 'Initials': 'BC', 'LastName': 'Taylor', 'Affiliation': 'Minneapolis VA Center for Care Delivery and Outcomes Research, Minneapolis, MN, USA; Section of General Medicine, University of Minnesota School of Medicine, Minneapolis MN, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Brawer', 'Affiliation': 'MDx Health, Irvine, CA, USA; Nanospectra Biosciences, Houston, TX, USA.'}]",European urology,['10.1016/j.eururo.2020.02.009']
3064,32084053,Brief Report: Long-Term Follow-up of Smokers Living With HIV After an Intensive Behavioral Tobacco Treatment Intervention.,"INTRODUCTION


Cigarette smoking is extremely common among persons living with HIV (PLWH) in the United States, and it has emerged as a leading killer in this group. No tobacco treatment studied to date has demonstrated long-term efficacy.
METHODS


This was a follow-up study of PLWH adult smokers who completed a randomized controlled trial of positively Smoke Free group therapy from 2014 to 2017. Participants from 2 of the 3 trial sites were recalled to complete a long-term follow-up assessment, at least one year after initial enrollment.
RESULTS


Of the 342 candidates for this follow-up study, 11 had died before our attempts to contact them, and 194 of the remaining 331 (58.6%) completed the late follow-up assessment. Most (91.2%) of the remaining candidates could not be contacted despite numerous attempts. At a mean of 38.1 months after initial study enrollment, using an intention-to-treat, lost to follow-up = still smoking (worst case scenario) strategy, 12.7% of group therapy vs. 6.6% of control participants had biochemically verified 7-day point-prevalence abstinence, odds ratio = 2.06 (95% CI: 0.96-4.41), P = 0.06, and 10.3% of group therapy vs. 4.2% of control participants had biochemically verified 12-month point-prevalence abstinence, odds ratio = 2.61 (95% CI: 1.05-6.47, P = 0.03). Improvements in abstinence self-efficacy in the positively Smoke Free group observed in the original study were sustained through late follow-up.
CONCLUSIONS


Targeted group therapy for PLWH smokers was associated with increased cessation and sustained improvements in abstinence self-efficacy at a mean of more than 3 years of follow-up. This is the first trial to show long-term efficacy of tobacco treatment for PLWH.",2020,"CONCLUSIONS


Targeted group therapy for PLWH smokers was associated with increased cessation and sustained improvements in abstinence self-efficacy at a mean of more than three years of follow-up.","['Participants from two of the three trial sites were recalled to complete a long-term follow-up assessment, at least one year after initial enrollment', 'persons living with HIV (PLWH', 'smokers living with HIV after an intensive behavioral tobacco treatment intervention', 'PLWH adult smokers', 'group therapy from 2014 to 2017', 'Of the 342 candidates for this follow-up study']",['Positively Smoke Free (PSF'],"['abstinence self-efficacy', 'biochemically-verified 7-day point-prevalence abstinence']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}]","[{'cui': 'C0037366', 'cui_str': 'Smoke'}]","[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",,0.0502146,"CONCLUSIONS


Targeted group therapy for PLWH smokers was associated with increased cessation and sustained improvements in abstinence self-efficacy at a mean of more than three years of follow-up.","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Shuter', 'Affiliation': 'Departments of aEpidemiology and Population Health bMedicine, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Ryung S', 'Initials': 'RS', 'LastName': 'Kim', 'Affiliation': 'Departments of aEpidemiology and Population Health bMedicine, Albert Einstein College of Medicine, Bronx, NY.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Durant', 'Affiliation': 'Montefiore Medical Center, Bronx, NY.'}, {'ForeName': 'Cassandra A', 'Initials': 'CA', 'LastName': 'Stanton', 'Affiliation': 'Behavioral Health and Health Policy Practice, Westat, Rockville, MD.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002330']
3065,32035706,Impact of HIV status and vaccination schedule on bacterial nasopharyngeal carriage following infant immunisation with the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in South Africa.,"BACKGROUND


Nasopharyngeal carriage (NPC) of Streptococcus pneumoniae is a precondition for pneumococcal disease and a source of transmission. This trial evaluated NPC of S. pneumoniae and other pathogens post-vaccination with the pneumococcal non-typeable Haemophilus influenzae (NTHi) protein D conjugate vaccine (PHiD-CV) in human immunodeficiency virus (HIV)-infected (HIV+), HIV-exposed-uninfected (HEU), and HIV-unexposed-uninfected (HUU) South African children.
METHODS


In this phase III, open, single-centre, controlled study (ClinicalTrials.gov: NCT00829010), 484 children were stratified by HIV status: 83 HIV+, 101 HEU, and 300 HUU. HIV+ and HEU children received a 3 + 1 PHiD-CV vaccination schedule: primary vaccination, age 6/10/14 weeks, and booster dose, age 9-10 months. HUU infants were randomised (1:1:1) to 3-dose priming and booster (HUU/3+1); 3-dose priming without booster (HUU/3+0); or 2-dose priming and booster (HUU/2+1). Bacterial NPC was assessed 8 times up to 24-27 months of age.
RESULTS


Overall pneumococcal carriage rates were similar across 3+1 groups irrespective of HIV status; trends towards higher carriage rates in the HIV+ than HEU and HUU/3+1 groups were observed at 24-27 months of age. In HUU children, carriage of any pneumococcal serotype was similar for the three different dosing schedules at all timepoints; carriage of vaccine-type pneumococci tended to be lower at 16-19 months and 24-27 months of age in children who had received a booster dose (HUU/2+1 and HUU/3+1 groups) than in the HUU/3+0 group. Carriage rates of NTHi, Staphylococcus aureus and Moraxella catarrhalis were comparable between all groups.
CONCLUSIONS


HIV infection or exposure did not seem to alter the effect of PHiD-CV on pneumococcal NPC in children during their first 2 years of life. NPC prevalence of vaccine-type pneumococci following vaccination series tended to be lower in children who had received a booster dose in comparison to those who had not.",2020,"In HUU children, carriage of any pneumococcal serotype was similar for the three different dosing schedules at all timepoints; carriage of vaccine-type pneumococci tended to be lower at 16-19 months and 24-27 months of age in children who had received a booster dose (HUU/2+1 and HUU/3+1 groups) than in the HUU/3+0 group.","['children who had received a booster dose in comparison to those who had not', '484 children were stratified by HIV status: 83 HIV+, 101 HEU, and 300 HUU', 'human immunodeficiency virus (HIV)-infected (HIV+), HIV-exposed-uninfected (HEU), and HIV-unexposed-uninfected (HUU) South African children', 'bacterial nasopharyngeal carriage following infant immunisation with the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in South Africa', 'HUU infants']","['pneumococcal non-typeable Haemophilus influenzae (NTHi) protein D conjugate vaccine (PHiD-CV', '3-dose priming and booster (HUU/3+1', 'vaccine-type pneumococci', '3-dose priming without booster (HUU/3+0); or 2-dose priming and booster (HUU/2+1']","['Bacterial NPC', 'carriage of any pneumococcal serotype', 'carriage rates', 'Overall pneumococcal carriage rates', 'Carriage rates of NTHi, Staphylococcus aureus and Moraxella catarrhalis']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0138826', 'cui_str': 'surface-exposed lipoprotein D, Haemophilus influenzae'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0138826', 'cui_str': 'surface-exposed lipoprotein D, Haemophilus influenzae'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0026536', 'cui_str': 'Moraxella'}]",484.0,0.267089,"In HUU children, carriage of any pneumococcal serotype was similar for the three different dosing schedules at all timepoints; carriage of vaccine-type pneumococci tended to be lower at 16-19 months and 24-27 months of age in children who had received a booster dose (HUU/2+1 and HUU/3+1 groups) than in the HUU/3+0 group.","[{'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: madhis@rmpru.co.za.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Moreira', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Anthonet', 'Initials': 'A', 'LastName': 'Koen', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: koena@rmpru.co.za.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'van Niekerk', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'de Gouveia', 'Affiliation': 'Centre for Respiratory Diseases and Meningitis, National Institute for Communicable Diseases: a Division of National Health Laboratory Service, Johannesburg, South Africa. Electronic address: lindad@nicd.ac.za.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jose', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: josel@rmpru.co.za.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation: Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: cutlandc@rmpru.co.za.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'François', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: nancy.a.francois@gsk.com.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Schoonbroodt', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: sonia.j.schoonbroodt@gsk.com.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Ruiz-Guiñazú', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: javier.x.ruiz@gsk.com.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Yarzabal', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: juan.p.yarzabal@gsk.com.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Borys', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: dorota.d.borys@gsk.com.'}, {'ForeName': 'Lode', 'Initials': 'L', 'LastName': 'Schuerman', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: lode.schuerman@gsk.com.'}]",Vaccine,['10.1016/j.vaccine.2020.01.062']
3066,32063178,Locomotor training intensity after stroke: Effects of interval type and mode.,"Background and Objectives : High-intensity interval training (HIIT) is a promising strategy for improving gait and fitness after stroke, but optimal parameters remain unknown. We tested the effects of short vs long interval type and over-ground vs treadmill mode on training intensity. Methods : Using a repeated measures design, 10 participants with chronic hemiparesis performed 12 HIIT sessions over 4 weeks, alternating between short and long-interval HIIT sessions. Both protocols included 10 minutes of over-ground HIIT, 20 minutes of treadmill HIIT and another 10 minutes over-ground. Short-interval HIIT involved 30 second bursts at maximum safe speed and 30-60 second rest periods. Long-interval HIIT involved 4-minute bursts at ~90% of peak heart rate (HR peak ) and 3-minute recovery periods at ~70% HR peak . Results : Compared with long-interval HIIT, short-interval HIIT had significantly faster mean overground speeds (0.75 vs 0.67 m/s) and treadmill speeds (0.90 vs 0.51 m/s), with similar mean treadmill HR (82.9 vs 81.8%HR peak ) and session perceived exertion (16.3 vs 16.3), but lower overground HR (78.4 vs 81.1%HR peak ) and session step counts (1481 vs 1672). For short-interval HIIT, training speeds and HR were significantly higher on the treadmill vs. overground. For long-interval HIIT, the treadmill elicited HR similar to overground training at significantly slower speeds. Conclusions : Both short and long-interval HIIT elicit high intensities but emphasize different dosing parameters. From these preliminary findings and previous studies, we hypothesize that overground and treadmill short-interval HIIT could be optimal for improving gait speed and overground long-interval HIIT could be optimal for improving gait endurance.",2020,"Compared with long-interval HIIT, short-interval HIIT had significantly faster mean overground speeds (0.75 vs 0.67 m/s) and treadmill speeds (0.90 vs 0.51 m/s), with similar mean treadmill HR (82.9 vs 81.8%HR peak ) and session perceived exertion (16.3 vs 16.3), but lower overground HR (78.4 vs 81.1%HR peak ) and session step counts (1481 vs 1672).",['10 participants with chronic hemiparesis'],['intensity interval training (HIIT'],"['peak heart rate (HR peak ', 'treadmill speeds']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0457436', 'cui_str': 'Left hemiparesis (disorder)'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}]",10.0,0.0695711,"Compared with long-interval HIIT, short-interval HIIT had significantly faster mean overground speeds (0.75 vs 0.67 m/s) and treadmill speeds (0.90 vs 0.51 m/s), with similar mean treadmill HR (82.9 vs 81.8%HR peak ) and session perceived exertion (16.3 vs 16.3), but lower overground HR (78.4 vs 81.1%HR peak ) and session step counts (1481 vs 1672).","[{'ForeName': 'Pierce', 'Initials': 'P', 'LastName': 'Boyne', 'Affiliation': 'Department of Rehabilitation, Exercise and Nutrition Sciences, College of Allied Health Sciences, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Scholl', 'Affiliation': 'Department of Rehabilitation, Exercise and Nutrition Sciences, College of Allied Health Sciences, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Doren', 'Affiliation': 'Department of Rehabilitation, Exercise and Nutrition Sciences, College of Allied Health Sciences, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Carl', 'Affiliation': 'Department of Rehabilitation, Exercise and Nutrition Sciences, College of Allied Health Sciences, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Sandra A', 'Initials': 'SA', 'LastName': 'Billinger', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, School of Health Professions, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Darcy S', 'Initials': 'DS', 'LastName': 'Reisman', 'Affiliation': 'Department of Physical Therapy, College of Health Sciences, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Myron', 'Initials': 'M', 'LastName': 'Gerson', 'Affiliation': 'Departments of Internal Medicine and Cardiology, College of Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Kissela', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, College of Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Vannest', 'Affiliation': 'Department of Communication Sciences and Disorders, College of Allied Health Sciences, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Dunning', 'Affiliation': 'Department of Rehabilitation, Exercise and Nutrition Sciences, College of Allied Health Sciences, University of Cincinnati, Cincinnati, OH, USA.'}]",Topics in stroke rehabilitation,['10.1080/10749357.2020.1728953']
3067,32086442,"The effects of 10,000 voluntary contractions over 8 weeks on the strength of very weak muscles in people with spinal cord injury: a randomised controlled trial.","STUDY DESIGN


A multi-centred, single-blinded randomised controlled trial.
OBJECTIVES


To determine the effect of 10,000 voluntary contractions over 8 weeks on the strength of very weak muscles in people with spinal cord injury (SCI).
SETTINGS


Seven hospitals in Australia and Asia.
METHODS


One hundred and twenty people with recent SCI undergoing inpatient rehabilitation were randomised to either a Treatment or Control Group. One major muscle group from an upper or lower limb was selected if the muscle had grade 1 or grade 2 strength on a standard six-point manual muscle test. Participants allocated to the Treatment Group performed 10,000 isolated contractions of the selected muscle group, as well as usual care in 48 sessions over 8 weeks. Participants allocated to the Control Group received usual care alone. Participants were assessed at baseline and 8 weeks by a blinded assessor. The primary outcome was voluntary muscle strength on a 13-point manual muscle test. There were three secondary outcomes capturing therapists' and participants' perceptions of strength and function.
RESULTS


The mean between-group difference of voluntary strength at 8 weeks was 0.4/13 points (95% confidence interval -0.5 to 1.4) in favour of the Treatment Group. There were no notable between-group differences on any secondary outcome.
CONCLUSION


Ten thousand isolated contractions of very weak muscles in people with SCI over 8 weeks has either no or a very small effect on voluntary strength.",2020,The mean between-group difference of voluntary strength at 8 weeks was 0.4/13 points (95% confidence interval -0.5 to 1.4) in favour of the Treatment Group.,"['One hundred and twenty people with recent SCI undergoing inpatient rehabilitation', 'people with spinal cord injury (SCI', 'Seven hospitals in Australia and Asia', 'people with spinal cord injury']",['Control Group received usual care alone'],"['voluntary strength', 'perceptions of strength and function', 'voluntary muscle strength on a 13-point manual muscle test']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0003980', 'cui_str': 'Asia'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0451362', 'cui_str': 'Oxford grading scale for muscle strength (assessment scale)'}]",10000.0,0.21565,The mean between-group difference of voluntary strength at 8 weeks was 0.4/13 points (95% confidence interval -0.5 to 1.4) in favour of the Treatment Group.,"[{'ForeName': 'Lydia W', 'Initials': 'LW', 'LastName': 'Chen', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Faculty of Medicine and Health Sciences, University of Sydney, St Leonards, NSW, Australia.'}, {'ForeName': 'Joanne V', 'Initials': 'JV', 'LastName': 'Glinsky', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Faculty of Medicine and Health Sciences, University of Sydney, St Leonards, NSW, Australia.'}, {'ForeName': 'Md Shofiqul', 'Initials': 'MS', 'LastName': 'Islam', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Muzaffor', 'Initials': 'M', 'LastName': 'Hossain', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Boswell-Ruys', 'Affiliation': 'Spinal Injuries Unit, Prince of Wales Hospital, Randwick, NSW, Australia.'}, {'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Kataria', 'Affiliation': 'Indian Spinal Injuries Centre, Sector-C, Vasant Kunj, Delhi, India.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Redhead', 'Affiliation': 'Spinal Injuries Unit, Royal Rehab, Ryde, NSW, Australia.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'Guangdong Work Injury Rehabilitation Hospital, Guangdong, China.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Gollan', 'Affiliation': 'Queensland Spinal Cord Injuries Service, Metro South Health, Brisbane, QLD, Australia.'}, {'ForeName': 'Punam D', 'Initials': 'PD', 'LastName': 'Costa', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Denis', 'Affiliation': 'Spinal Injuries Unit, Prince of Wales Hospital, Randwick, NSW, Australia.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Ben', 'Affiliation': 'NSW Spinal Outreach Service, Ryde, NSW, Australia.'}, {'ForeName': 'Lovely', 'Initials': 'L', 'LastName': 'Chaudhary', 'Affiliation': 'Indian Spinal Injuries Centre, Sector-C, Vasant Kunj, Delhi, India.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Guangdong Work Injury Rehabilitation Hospital, Guangdong, China.'}, {'ForeName': 'Md Abu Khayer', 'Initials': 'MAK', 'LastName': 'Hasnat', 'Affiliation': 'Centre for the Rehabilitation of the Paralysed, Savar, Dhaka, Bangladesh.'}, {'ForeName': 'Jayne', 'Initials': 'J', 'LastName': 'Yeomans', 'Affiliation': 'Spinal Injuries Unit, Royal North Shore Hospital, St Leonards, NSW, Australia.'}, {'ForeName': 'Simon C', 'Initials': 'SC', 'LastName': 'Gandevia', 'Affiliation': 'Neuroscience Research Australia (NeuRA), University of New South Wales, Randwick, NSW, Australia.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Harvey', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Faculty of Medicine and Health Sciences, University of Sydney, St Leonards, NSW, Australia. lisa.harvey@sydney.edu.au.'}]",Spinal cord,['10.1038/s41393-020-0439-1']
3068,32083500,"Effect of Exergaming on Muscle Strength, Pain, and Functionality of Shoulders in Cancer Patients.","Objective:  To compare the strength of the middle deltoid muscle by means of dynamometry and the Shoulder Pain and Disability Index (SPADI) in participants in treatment for cancer after the practice of an exergaming protocol.  Materials and Methods:  We conducted a randomized controlled clinical trial. Thirty-eight voluntary participants were divided into two groups :  cancer group ( n  = 19; age = 61.46 ± 8.79 years; body mass index [BMI] = 28.36 ± 4.94 kg/m 3 ) and control group ( n  = 19; age = 57.62 ± 7.57 years; BMI = 28.06 ± 3.74 kg/m 3 ), and they participated in the study. All participants performed an exergame protocol by using Xbox 360 Kinect ®  (Microsoft, Redmond) with the game  Your Shape Fitness Evolved 2012  two to three times per week for 20 sessions. They were evaluated through the isometric dynamometer in the middle deltoid muscle and the SPADI at three moments: preintervention (EV1), after 10 sessions (EV2), and after 20 sessions (EV3).  Results:  The cancer group scored higher on both the disability index, in all three evaluations, and the pain index, in EV2 and EV3, when compared with the control group. There was a significant reduction in the disability score in EV2 and EV3 when compared with EV1 in the cancer group, whereas pain was lower in EV2 and EV3 when compared with EV1 in the control group. There were no significant interevaluation or intergroup differences in the maximal isometric voluntary contraction of the deltoid muscle of both upper limbs.  Conclusion:  At the end of the exergaming, protocol reduced the disability of the shoulder joint of the cancer group and decreased the differences between the groups for disability and pain scores, without changing isometric force.",2020,"There was a significant reduction in the disability score in EV2 and EV3 when compared with EV1 in the cancer group, whereas pain was lower in EV2 and EV3 when compared with EV1 in the control group.","['Thirty-eight voluntary participants', 'participants in treatment for cancer after the practice of an exergaming protocol', 'Cancer Patients']","['exergame protocol by using Xbox 360 Kinect ®  (Microsoft, Redmond) with the game']","['Shoulder Pain and Disability Index (SPADI', 'disability of the shoulder joint', 'disability and pain scores', 'disability index', 'pain index', 'Muscle Strength, Pain, and Functionality of Shoulders', 'maximal isometric voluntary contraction of the deltoid muscle of both upper limbs', 'disability score in EV2 and EV3', 'pain']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0037009', 'cui_str': 'Glenohumeral Joint'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0224234', 'cui_str': 'Deltoid Muscle'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",38.0,0.0429863,"There was a significant reduction in the disability score in EV2 and EV3 when compared with EV1 in the cancer group, whereas pain was lower in EV2 and EV3 when compared with EV1 in the control group.","[{'ForeName': 'Paulo Furtado', 'Initials': 'PF', 'LastName': 'de Oliveira', 'Affiliation': 'Motricity of Sciences Institute, and Federal University of Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Ricardo da Silva', 'Initials': 'RDS', 'LastName': 'Alves', 'Affiliation': 'Bioscience Program, Federal University of Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Denise Hollanda', 'Initials': 'DH', 'LastName': 'Iunes', 'Affiliation': 'Motricity of Sciences Institute, and Federal University of Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Jovana Maria', 'Initials': 'JM', 'LastName': 'de Carvalho', 'Affiliation': 'Motricity of Sciences Institute, and Federal University of Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Juliana Bassalobre Carvalho', 'Initials': 'JBC', 'LastName': 'Borges', 'Affiliation': 'Motricity of Sciences Institute, and Federal University of Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Flávia da Silva', 'Initials': 'FDS', 'LastName': 'Menezes', 'Affiliation': 'Motricity of Sciences Institute, and Federal University of Alfenas, Alfenas, Brazil.'}, {'ForeName': 'Leonardo César', 'Initials': 'LC', 'LastName': 'Carvalho', 'Affiliation': 'Motricity of Sciences Institute, and Federal University of Alfenas, Alfenas, Brazil.'}]",Games for health journal,['10.1089/g4h.2019.0113']
3069,32078815,"Comparison of shortened mosaic HIV-1 vaccine schedules: a randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) and a preclinical study in rhesus monkeys (NHP 17-22).","BACKGROUND


Current efficacy studies of a mosaic HIV-1 prophylactic vaccine require four vaccination visits over one year, which is a complex regimen that could prove challenging for vaccine delivery at the community level, both for recipients and clinics. In this study, we evaluated the safety, tolerability, and immunogenicity of shorter, simpler regimens of trivalent Ad26.Mos.HIV expressing mosaic HIV-1 Env/Gag/Pol antigens combined with aluminium phosphate-adjuvanted clade C gp140 protein.
METHODS


We did this randomised, double-blind, placebo-controlled phase 1 trial (IPCAVD010/HPX1002) at Beth Israel Deaconess Medical Center in Boston, MA, USA. We included healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement. We randomly assigned participants via a computer-generated randomisation schedule and interactive web response system to one of three study groups (1:1:1) testing different regimens of trivalent Ad26.Mos.HIV (5 × 10 10  viral particles per 0·5 mL) combined with 250 μg adjuvanted clade C gp140 protein. They were then assigned to treatment or placebo subgroups (5:1) within each of the three main groups. Participants and investigators were masked to treatment allocation until the end of the follow-up period. Group 1 received Ad26.Mos.HIV alone at weeks 0 and 12 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 24 and 48. Group 2 received Ad26.Mos.HIV plus adjuvanted gp140 at weeks 0, 12, and 24. Group 3 received Ad26.Mos.HIV alone at week 0 and Ad26.Mos.HIV plus adjuvanted gp140 at weeks 8 and 24. Participants in the control group received 0·5 mL of 0·9% saline. All study interventions were administered intramuscularly. The primary endpoints were Env-specific binding antibody responses at weeks 28, 52, and 72 and safety and tolerability of the vaccine regimens for 28 days after the injection. All participants who received at least one vaccine dose or placebo were included in the safety analysis; immunogenicity was analysed using the per-protocol population. The IPCAVD010/HPX1002 trial is registered with ClinicalTrials.gov, NCT02685020. We also did a parallel preclinical study in rhesus monkeys to test the protective efficacy of the shortened group 3 regimen.
FINDINGS


Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study vaccine or placebo, ten to each vaccine group and two to the corresponding placebo group. 30 (83%) participants completed the full study, and six (17%) discontinued it prematurely because of loss to follow-up, withdrawal of consent, investigator decision, and an unrelated death from a motor vehicle accident. The two shortened regimens elicited comparable antibody titres against autologous clade C Env at peak immunity to the longer, 12-month regimen: geometric mean titre (GMT) 41 007 (95% CI 17 959-93 636) for group 2 and 49 243 (29 346-82 630) for group 3 at week 28 compared with 44 590 (19 345-102 781) for group 1 at week 52). Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72. Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses were detected in all groups. All vaccine regimens were well tolerated. Mild-to-moderate pain or tenderness at the injection site was the most commonly reported solicited local adverse event, reported by 28 vaccine recipients (93%) and two placebo recipients (33%). Grade 3 solicited systemic adverse events were reported by eight (27%) vaccine recipients and no placebo recipients; the most commonly reported grade 3 systemic symptoms were fatigue, myalgia, and chills. The shortened group 3 regimen induced comparable peak immune responses in 30 rhesus monkeys as in humans and resulted in an 83% (95% CI 38·7-95, p=0·004 log-rank test) reduction in per-exposure acquisition risk after six intrarectal challenges with SHIV-SF162P3 at week 54, more than 6 months after final vaccination.
INTERPRETATION


Short, 6-month regimens of a mosaic HIV-1 prophylactic vaccine elicited robust HIV-specific immune responses that were similar to responses elicited by a longer, 12-month schedule. Preclinical data showed partial protective efficacy of one of the short vaccine regimens in rhesus monkeys. Further clinical studies are required to test the suitability of the shortened vaccine regimens in humans. Such shortened regimens would be valuable to increase vaccine delivery at the community level, particularly in resource-limited settings.
FUNDING


Ragon Institute (Massachusetts General Hospital, Massachusetts Institute of Technology, and Harvard University; Cambridge, MA, USA) and Janssen Vaccines & Prevention (Leiden, Netherlands).",2020,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"['HIV (5', 'rhesus monkeys (NHP 17-22', 'All participants who received at least one vaccine dose or', 'healthy, HIV-uninfected participants (aged 18-50 years) who were considered at low risk for HIV infection and had not received any vaccines in the 14 days before study commencement', 'HIV expressing mosaic HIV-1', 'Between March 7, 2016, and Aug 19, 2016, we randomly assigned 36 participants to receive at least one dose of study', 'rhesus monkeys']","['placebo', '0·5 mL of 0·9% saline', 'aluminium phosphate-adjuvanted clade C gp140 protein', 'vaccine or placebo']","['Antibody-dependent cellular phagocytosis, Env-specific IgG3, tier 1A neutralising activity, and broad cellular immune responses', 'Mild-to-moderate pain or tenderness', 'tolerated', 'Grade 3 solicited systemic adverse events', 'grade 3 systemic symptoms were fatigue, myalgia, and chills', 'safety, tolerability, and immunogenicity', 'partial protective efficacy', 'Env-specific binding antibody responses', 'peak immune responses', 'safety and tolerability', 'Antibody responses', 'protective efficacy', 'safety analysis; immunogenicity']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439750', 'cui_str': 'Mosaic (qualifier value)'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0051519', 'cui_str': 'aluminium phosphate'}, {'cui': 'C0061830', 'cui_str': 'GP140'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020859', 'cui_str': 'IgG3'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0085593', 'cui_str': 'Chills'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1145667', 'cui_str': 'Binding - action (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",36.0,0.574721,Antibody responses remained increased (GMT >5000) in groups 2 and 3 at week 52 but were highest in group 1 at week 72.,"[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Wegmann', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tomaka', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'C Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Ludo', 'Initials': 'L', 'LastName': 'Lavreys', 'Affiliation': 'Janssen Research & Development, Titusville, NJ, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Howe', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Darla', 'Initials': 'D', 'LastName': 'Quijada', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Esther A', 'Initials': 'EA', 'LastName': 'Bondzie', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hendriks', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Nijs', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Truyers', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Tolboom', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Zahn', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Stieh', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Pau', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Hanneke', 'Initials': 'H', 'LastName': 'Schuitemaker', 'Affiliation': 'Janssen Vaccines & Prevention BV, Leiden, Netherlands.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30001-1']
3070,32054486,The acute effects of thermogenic fitness drink formulas containing 140 mg and 100 mg of caffeine on energy expenditure and fat metabolism at rest and during exercise.,"BACKGROUND


Thermogenic fitness drink formulas (TFD) have been shown to increase energy expenditure and markers of lipid metabolism. The purpose of the current study was to compare TFD formulas containing different caffeine concentrations versus a placebo drink on energy expenditure and lipid metabolism at rest and during exercise.
METHODS


Thirty-two recreationally active participants (22.9 ± 0.7 y, 167.1 ± 1.4 cm, 68.8 ± 2.0 kg, 24.0 ± 1.2% fat) who were regular caffeine consumers, participated in this randomized, double-blind, crossover design study. Participants reported to the laboratory on three occasions, each of which required consumption of either a TFD containing 140 mg or 100 mg of caffeine or a placebo. Baseline measurements of resting energy expenditure (REE) and resting fat oxidation (RFO) were assessed using indirect calorimetry as well as measurements of serum glycerol concentration. Measurements were repeated at 30, 60, 90 min post-ingestion. Following resting measures, participants completed a graded exercise test to determine maximal oxygen uptake (V̇O 2max ), maximal fat oxidation (MFO) and the exercise intensity that elicits MFO (Fat max ), and total energy expenditure (EE).
RESULTS


A significant interaction was shown for REE (p < 0.01) and RFO (p < 0.01). Area under the curve analysis showed an increased REE for the 140 mg compared to the 100 mg formula (p = 0.02) and placebo (p < 0.01) and an increased REE for the 100 mg formula compared to placebo (p = 0.02). RFO significantly decreased for caffeinated formulas at 30 min post ingestion compared to placebo and baseline (p < 0.01) and significantly increased for the 140 mg formula at 60 min post-ingestion (p = 0.03). A main effect was shown for serum glycerol concentrations over time (p < 0.01). No significant differences were shown for V̇O 2max  (p = 0.12), Fat max  (p = 0.22), and MFO (p = 0.05), and EE (p = 0.08) across drinks.
CONCLUSIONS


Our results suggest that TFD formulas containing 100 and 140 mg of caffeine are effective in increasing REE and that a 40 mg of caffeine difference between the tested formulas may impact REE and RFO in healthy individuals within 60 min of ingestion.",2020,A significant interaction was shown for REE (p < 0.01) and RFO (p < 0.01).,"['Thirty-two recreationally active participants (22.9\u2009±\u20090.7 y, 167.1\u2009±\u20091.4\u2009cm, 68.8\u2009±\u20092.0\u2009kg, 24.0\u2009±\u20091.2% fat) who were regular caffeine consumers', 'healthy individuals within 60\u2009min of ingestion']","['Thermogenic fitness drink formulas (TFD', 'thermogenic fitness drink formulas containing 140\u2009mg and 100\u2009mg of caffeine', 'placebo', 'caffeine', 'placebo drink', 'TFD containing 140\u2009mg or 100\u2009mg of caffeine']","['resting energy expenditure (REE) and resting fat oxidation (RFO', 'REE', 'maximal oxygen uptake (V̇O 2max ), maximal fat oxidation (MFO) and the exercise intensity that elicits MFO (Fat max ), and total energy expenditure (EE', 'energy expenditure and fat metabolism', 'serum glycerol concentrations', 'V̇O 2max', 'MFO', 'energy expenditure and lipid metabolism', 'Fat max', 'RFO']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure (observable entity)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}]",32.0,0.41453,A significant interaction was shown for REE (p < 0.01) and RFO (p < 0.01).,"[{'ForeName': 'Nicolas W', 'Initials': 'NW', 'LastName': 'Clark', 'Affiliation': 'School of Kinesiology and Physical Therapy, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, Orlando, Florida, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Wells', 'Affiliation': 'School of Kinesiology and Physical Therapy, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, Orlando, Florida, USA.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Coker', 'Affiliation': 'School of Kinesiology and Physical Therapy, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, Orlando, Florida, USA.'}, {'ForeName': 'Erica R', 'Initials': 'ER', 'LastName': 'Goldstein', 'Affiliation': 'School of Kinesiology and Physical Therapy, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, Orlando, Florida, USA.'}, {'ForeName': 'Chad H', 'Initials': 'CH', 'LastName': 'Herring', 'Affiliation': 'School of Kinesiology and Physical Therapy, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, Orlando, Florida, USA.'}, {'ForeName': 'Tristan M', 'Initials': 'TM', 'LastName': 'Starling-Smith', 'Affiliation': 'School of Kinesiology and Physical Therapy, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, Orlando, Florida, USA.'}, {'ForeName': 'Alyssa N', 'Initials': 'AN', 'LastName': 'Varanoske', 'Affiliation': 'School of Kinesiology and Physical Therapy, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, Orlando, Florida, USA.'}, {'ForeName': 'Valeria L G', 'Initials': 'VLG', 'LastName': 'Panissa', 'Affiliation': 'Department of Sport, School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Stout', 'Affiliation': 'School of Kinesiology and Physical Therapy, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, Orlando, Florida, USA.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Fukuda', 'Affiliation': 'School of Kinesiology and Physical Therapy, Institute of Exercise Physiology and Rehabilitation Science, University of Central Florida, Orlando, Florida, USA. david.fukuda@ucf.edu.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-0341-4']
3071,31349187,Acute effects of salbutamol on systemic vascular function in people with asthma.,"BACKGROUND


Asthmatics are at increased cardiovascular disease risk, which has been linked to beta2(β 2 )-agonist use. Inhalation of β 2 -agonists increases sympathetic nerve activity (SNA) in healthy individuals, however the systemic impact of salbutamol in asthmatics using β 2 -agonists regularly is unknown.
OBJECTIVES


This study compared the systemic vascular responses to a clinical dose of salbutamol (Phase I) and following an acute increase in SNA (Phase II) in asthmatics and controls.
METHODS


Fourteen controls and 14 asthmatics were recruited for Phase I. On separate days, flow-mediated dilation (FMD) and peripheral arterial stiffness (pPWV) were evaluated at baseline and following either 400 μg inhaled salbutamol or a placebo inhaler. For Phase II, heart rate, blood pressure, vascular conductance, pPWV, and central (c)PWV were evaluated in response to a large increase in SNA brought on by cold-water hand immersion (i.e. cold-pressor test) or body-temperature water hand immersion (i.e. control) in 10 controls and 10 asthmatics.
RESULTS


Following salbutamol, asthmatics demonstrated reduced FMD (-3.0%, p < 0.05) and increased pPWV (+0.7 m/s, p < 0.05); however, salbutamol had no effect in controls. The cold-pressor test resulted in similar increases in blood pressure, vascular flow rates and conductance, pPWV, and cPWV in both asthmatics and controls, suggesting similar neurovascular transduction in asthmatics and controls.
CONCLUSION


Inhaled Salbutamol leads to increased arterial stiffness and reduced FMD in asthmatics. As asthmatics and controls had similar vascular responses to an increase in SNA, these findings suggest asthmatics have heightened sympathetic responses to β 2 -agonists which may contribute to the increased cardiovascular risk in asthma.",2019,"RESULTS


Following salbutamol, asthmatics demonstrated reduced FMD (-3.0%, p < 0.05) and increased pPWV (+0.7 m/s, p < 0.05); however, salbutamol had no effect in controls.","['people with asthma', 'healthy individuals', 'Fourteen controls and 14 asthmatics were recruited for Phase I', 'asthmatics']","['placebo inhaler', 'Inhaled Salbutamol', 'salbutamol']","['reduced FMD', 'systemic vascular function', 'flow-mediated dilation (FMD) and peripheral arterial stiffness (pPWV', 'blood pressure, vascular flow rates and conductance, pPWV, and cPWV', 'sympathetic nerve activity (SNA', 'pPWV', 'heart rate, blood pressure, vascular conductance, pPWV, and central (c)PWV', 'arterial stiffness and reduced FMD']","[{'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0599949', 'cui_str': 'Arterial Stiffness'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]",,0.112651,"RESULTS


Following salbutamol, asthmatics demonstrated reduced FMD (-3.0%, p < 0.05) and increased pPWV (+0.7 m/s, p < 0.05); however, salbutamol had no effect in controls.","[{'ForeName': 'Linn E', 'Initials': 'LE', 'LastName': 'Moore', 'Affiliation': 'Pulmonary Division, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, AB, Canada; Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Karishma', 'Initials': 'K', 'LastName': 'Kapoor', 'Affiliation': 'Pulmonary Division, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, AB, Canada; Department of Psychology, Faculty of Science, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Bradley W', 'Initials': 'BW', 'LastName': 'Byers', 'Affiliation': 'Pulmonary Division, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, AB, Canada; Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Brotto', 'Affiliation': 'Pulmonary Division, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, AB, Canada; Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ghods-Esfahani', 'Affiliation': 'Department of Biological Sciences, Faculty of Science, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Shelby L', 'Initials': 'SL', 'LastName': 'Henry', 'Affiliation': 'Pulmonary Division, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, AB, Canada; Department of Rehabilitation Science, Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Ryan B', 'Initials': 'RB', 'LastName': 'St James', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Stickland', 'Affiliation': 'Pulmonary Division, Department of Medicine, Faculty of Medicine and Dentistry, University of Alberta, AB, Canada. Electronic address: michael.stickland@ualberta.ca.'}]",Respiratory medicine,['10.1016/j.rmed.2019.07.018']
3072,32077951,Self-Reported Knee Pain Does Not Impact Physical Training Negatively in Conscripts.,"INTRODUCTION


Despite the great number of investigations on the effects of injuries during military service, there is limited information available on the use of self-reported instruments. This study evaluated self-reported knee pain (KP) and its effect on physical performance during military service in the Estonian Defense Forces.
MATERIAL AND METHODS


Ninety-five male conscripts aged 19-25 years were divided into two study groups based on the occurrence of KP or not. Self-reported KP and function according to the Knee Injury and Osteoarthritis Outcome Score (KOOS) were measured. Physical fitness level was scored using the Army Physical Fitness Test (APFT). KOOS and APFT were measured in the beginning and at the end of the 6-month period of military service.
RESULTS


Significant differences in favor of the group without KP (P < 0.001) were found for all subgroups of the KOOS. In spite of KP, the physical condition improved significantly (P < 0.001) in both study groups as measured with both the APFT test (22.2% increase) and running time (10.3% decrease).
CONCLUSION


In conclusion, self-reported KP and limited function according to KOOS did not hinder the improvement of physical condition and running speed as assessed by APFT in Estonian conscripts.",2020,"In spite of KP, the physical condition improved significantly (P < 0.001) in both study groups as measured with both the APFT test (22.2% increase) and running time (10.3% decrease).
",['Ninety-five male conscripts aged 19-25\xa0years'],[],"['running time', 'Knee Pain', 'Knee Injury and Osteoarthritis Outcome Score (KOOS', 'physical condition and running speed', 'KOOS and APFT', 'Physical fitness level']","[{'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",95.0,0.0258346,"In spite of KP, the physical condition improved significantly (P < 0.001) in both study groups as measured with both the APFT test (22.2% increase) and running time (10.3% decrease).
","[{'ForeName': 'Leho', 'Initials': 'L', 'LastName': 'Rips', 'Affiliation': 'Sports Traumatology Centre, Tartu University Hospital, Puusepa 1a, Tartu 50406.'}, {'ForeName': 'Madis', 'Initials': 'M', 'LastName': 'Rahu', 'Affiliation': 'Sports Traumatology Centre, Tartu University Hospital, Puusepa 1a, Tartu 50406.'}, {'ForeName': 'Rein', 'Initials': 'R', 'LastName': 'Kuik', 'Affiliation': 'Sports Traumatology Centre, Tartu University Hospital, Puusepa 1a, Tartu 50406.'}, {'ForeName': 'Ahti', 'Initials': 'A', 'LastName': 'Varblane', 'Affiliation': 'Estonian National Defence College, Centre of Military Disaster Medicine, Riia 12, Tartu 51010.'}, {'ForeName': 'Indrek', 'Initials': 'I', 'LastName': 'Olveti', 'Affiliation': 'Estonian National Defence College, Centre of Military Disaster Medicine, Riia 12, Tartu 51010.'}, {'ForeName': 'Vahur', 'Initials': 'V', 'LastName': 'Ööpik', 'Affiliation': 'Institute of Sports Science and Physiotherapy, University of Tartu, Ujula 4, Tartu 51008.'}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Mölder', 'Affiliation': 'Medical Centre of the 2nd Infantry Brigade CSS Battalion, Estonian Defence Forces, 3a Kose Road, Võru 65603.'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Timpmann', 'Affiliation': 'Institute of Sports Science and Physiotherapy, University of Tartu, Ujula 4, Tartu 51008.'}, {'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Tammaru', 'Affiliation': 'East-Tallinn Central Hospital, Ravi st 18, Tallinn 10138.'}, {'ForeName': 'Alar', 'Initials': 'A', 'LastName': 'Toom', 'Affiliation': 'Department of Orthopaedics, Central Finland Central Hospital, Keskussairaalantie 19, Jyväskylä 40620.'}, {'ForeName': 'Jüri-Toomas', 'Initials': 'JT', 'LastName': 'Kartus', 'Affiliation': 'Sports Traumatology Centre, Tartu University Hospital, Puusepa 1a, Tartu 50406.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Gapeyeva', 'Affiliation': 'Institute of Sports Science and Physiotherapy, University of Tartu, Ujula 4, Tartu 51008.'}]",Military medicine,['10.1093/milmed/usz486']
3073,32085946,"""Healthy""/""Unhealthy"" Food Brands Influence Health, Calorie, and Price Ratings of Food.","OBJECTIVE


To assess the effect of healthy or unhealthy food brands on consumer ratings of a food's perceived healthfulness, caloric content, and estimated price.
METHODS


Using a crossover design, 35 adults aged 18-25 years scored a variety of healthy and unhealthy foods paired with ""healthy"" or ""unhealthy"" brands or with no brand present, on their healthfulness, caloric content, and estimated price. For each outcome measure, ANOVA was used to evaluate the effect of brand condition on healthy and unhealthy foods.
RESULTS


Pairing an unhealthy food with a ""healthy brand"" led to increased ratings of healthfulness (P < .001), decreased estimates of caloric content (P < .001), and increased price (P < .001). Pairing a healthy food with an ""unhealthy brand"" led to decreased ratings of healthfulness (P < .001), increased estimates of caloric content (P < .001), and decreased price (P < .001).
CONCLUSIONS AND IMPLICATIONS


These findings extend previous research showing that brands may influence perceptions of food products. Future studies are needed to understand the implications of pairing healthy foods with ""unhealthy brands"" on actual food intake.",2020,"Pairing an unhealthy food with a ""healthy brand"" led to increased ratings of healthfulness (P < .001), decreased estimates of caloric content (P < .001), and increased price (P < .001).","['35 adults aged 18-25 years scored a variety of healthy and unhealthy foods paired with ""healthy"" or ""unhealthy"" brands or with no brand present, on their healthfulness, caloric content, and estimated price']",['healthy or unhealthy food brands'],"['ratings of healthfulness', 'caloric content', 'increased price']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0080045', 'cui_str': 'Prices'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0080045', 'cui_str': 'Prices'}]",35.0,0.0443924,"Pairing an unhealthy food with a ""healthy brand"" led to increased ratings of healthfulness (P < .001), decreased estimates of caloric content (P < .001), and increased price (P < .001).","[{'ForeName': 'Travis D', 'Initials': 'TD', 'LastName': 'Masterson', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine, Dartmouth College, Hanover, NH. Electronic address: Travis.D.Masterson@dartmouth.edu.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Florissi', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine, Dartmouth College, Hanover, NH.'}, {'ForeName': 'Kimberly R', 'Initials': 'KR', 'LastName': 'Clark', 'Affiliation': 'Department of Psychological and Brain Sciences, Dartmouth College, Hanover, NH.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Gilbert-Diamond', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine, Dartmouth College, Hanover, NH.'}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.01.008']
3074,31344660,"Effect of smoking status on lung function, patient-reported outcomes, and safety among patients with COPD treated with indacaterol/glycopyrrolate: Pooled analysis of the FLIGHT1 and FLIGHT2 studies.","BACKGROUND


Smoking continues to be a major risk factor for COPD and may impact the efficacy of COPD treatments, with guidelines supporting the crucial importance for current smokers of smoking cessation. A post-hoc analysis of the FLIGHT1 and FLIGHT2 studies assessed the impact of smoking status on the efficacy and safety of indacaterol/glycopyrrolate (IND/GLY) 27.5/15.6 μg twice daily versus its monocomponents or placebo in patients with COPD.
METHODS


This post-hoc analysis of pooled data from the replicate, 12-week, placebo-controlled FLIGHT1 and FLIGHT2 studies compared the efficacy and safety of IND/GLY with that of IND, GLY, and placebo in patients with moderate-to-severe COPD. Baseline data from 2038 patients were pooled and grouped by smoking status (52% were current smokers and 48% were ex-smokers). The effects of treatment on lung function, patient-reported outcomes (PROs), and safety were evaluated by baseline smoking status.
RESULTS


Treatment with IND/GLY resulted in significant improvements in lung function measurements compared with placebo, irrespective of smoking status. Improvements in St George's Respiratory Questionnaire and transition dyspnea index were significantly greater than placebo in both current and ex-smokers, whereas changes in COPD assessment test were significant only among current smokers. Improvements in lung function and PROs were greater with IND/GLY compared with its monocomponents in current and ex-smokers. The incidences of AEs and SAEs were similar between current and ex-smokers.
CONCLUSIONS


IND/GLY demonstrated significant improvements in lung function and PROs, independent of baseline smoking status. The safety profile of IND/GLY did not differ between current and ex-smokers.",2019,Improvements in lung function and PROs were greater with IND/,"['patients with COPD', '2038 patients were pooled and grouped by smoking status (52% were current smokers and 48% were ex-smokers', 'patients with COPD treated with', 'patients with moderate-to-severe COPD']","['indacaterol/glycopyrrolate (IND/GLY', 'placebo', 'indacaterol/glycopyrrolate', 'GLY']","['lung function and PROs, independent of baseline smoking status', 'lung function measurements', 'lung function and PROs', 'incidences of AEs and SAEs', 'safety profile of IND/GLY', 'COPD assessment test', 'lung function, patient-reported outcomes (PROs), and safety', ""St George's Respiratory Questionnaire and transition dyspnea index""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3241966'}, {'cui': 'C4555205', 'cui_str': 'Ex-Smokers'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C1722260', 'cui_str': 'indacaterol'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0332291', 'cui_str': 'Independent of (attribute)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",2038.0,0.0226269,Improvements in lung function and PROs were greater with IND/,"[{'ForeName': 'Donald P', 'Initials': 'DP', 'LastName': 'Tashkin', 'Affiliation': 'David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA, USA. Electronic address: dtashkin@mednet.ucla.edu.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Goodin', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Alyssa', 'Initials': 'A', 'LastName': 'Bowling', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Price', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Ayca', 'Initials': 'A', 'LastName': 'Ozol-Godfrey', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Sanjar', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}]",Respiratory medicine,['10.1016/j.rmed.2019.07.019']
3075,32043762,Oral Care Evaluation to Prevent Oral Mucositis in Estrogen Receptor-Positive Metastatic Breast Cancer Patients Treated with Everolimus (Oral Care-BC): A Randomized Controlled Phase III Trial.,"BACKGROUND


The incidence of oral mucositis (any grade) after everolimus treatment is 58% in the general population and 81% in Asian patients. This study hypothesized that professional oral care (POC) before everolimus treatment could reduce the incidence of everolimus-induced oral mucositis.
MATERIALS AND METHODS


This randomized, multicenter, open-label, phase III study evaluated the efficacy of POC in preventing everolimus-induced mucositis. Patients were randomized into POC and control groups (1:1 ratio) and received everolimus with exemestane. Patients in the POC group underwent teeth surface cleaning, scaling, and tongue cleaning before everolimus initiation and continued to receive weekly POC throughout the 8-week treatment period. Patients in the control group brushed their own teeth and gargled with 0.9% sodium chloride solution or water. The primary endpoint was the incidence of all grades of oral mucositis. We targeted acquisition of 200 patients with a 2-sided type I error rate of 5% and 80% power to detect 25% risk reduction.
RESULTS


Between March 2015 and December 2017, we enrolled 175 women from 31 institutions, of which five did not receive the protocol treatment and were excluded. Over the 8 weeks, the incidence of grade 1 oral mucositis was significantly different between the POC group (76.5%, 62 of 82 patients) and control group (89.7%, 78 of 87 patients; p = .034). The incidence of grade 2 (severe) oral mucositis was also significantly different between the POC group (34.6%, 28 of 82 patients) and control group (54%, 47 of 87 patients; p = .015). As a result of oral mucositis, 18 (22.0%) patients in the POC group and 28 (32.2%) in the control group had to undergo everolimus dose reduction.
CONCLUSION


POC reduced the incidence and severity of oral mucositis in patients receiving everolimus and exemestane. This might be considered as a treatment option of oral care for patients undergoing this treatment. Clinical trial identification number: NCT02069093.
IMPLICATIONS FOR PRACTICE


The Oral Care-BC trial that prophylactically used professional oral care (POC), available worldwide, did not show a greater than 25% difference in mucositis. The 12% difference in grade 1 or higher mucositis and especially the ∼20% difference in grade 2 mucositis are likely clinically meaningful to patients. POC before treatment should be considered as a treatment option of oral care for postmenopausal patients who are receiving everolimus and exemestane for treatment of hormone receptor-positive, HER2-negative advanced breast cancer and metastatic breast cancer. However, POC was not adequate for prophylactic oral mucositis in these patients, and dexamethasone mouthwash prophylaxis is standard treatment before everolimus.",2020,"The incidence of grade 2 (severe) oral mucositis was also significantly different between the POC group (34.6%, 28 of 82 patients) and control group (54%, 47 of 87 patients; p = .015).","['175 women from 31 institutions, of which five did not receive the protocol treatment and were excluded', '200 patients with a 2-sided type I error rate of 5% and 80% power to detect 25% risk reduction', 'Between March 2015 and December 2017', 'for treatment of hormone receptor-positive, HER2-negative advanced breast cancer and metastatic breast cancer', 'postmenopausal patients who are receiving', 'Estrogen Receptor-Positive Metastatic Breast Cancer Patients', 'patients undergoing this treatment', 'general population and 81% in Asian patients']","['Oral Care Evaluation', 'sodium chloride solution or water', 'Everolimus (Oral Care-BC', 'everolimus with exemestane', 'everolimus and exemestane']","['incidence and severity of oral mucositis', 'incidence of everolimus-induced oral mucositis', 'mucositis', 'grade 1 or higher mucositis', 'incidence of grade 1 oral mucositis', 'Oral Mucositis', 'prophylactic oral mucositis', 'grade 2 mucositis', 'incidence of all grades of oral mucositis', 'incidence of grade 2 (severe) oral mucositis', 'oral mucositis']","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0078988', 'cui_str': 'Asians'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C1568868', 'cui_str': 'Oral Mucositis'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}]",175.0,0.029655,"The incidence of grade 2 (severe) oral mucositis was also significantly different between the POC group (34.6%, 28 of 82 patients) and control group (54%, 47 of 87 patients; p = .015).","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Niikura', 'Affiliation': 'Department of Breast and Endocrine Surgery, Tokai University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Katsuhiko', 'Initials': 'K', 'LastName': 'Nakatukasa', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Amemiya', 'Affiliation': 'Department of Dentistry and Oral and Maxillofacial Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.'}, {'ForeName': 'Ken-Ichi', 'Initials': 'KI', 'LastName': 'Watanabe', 'Affiliation': 'Department of Breast Surgery, Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Hironobu', 'Initials': 'H', 'LastName': 'Hata', 'Affiliation': 'Department of Dentistry, Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kikawa', 'Affiliation': 'Department of Breast Surgery, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Taniike', 'Affiliation': 'Department of Dentistry and Oral and Maxillofacial Surgery, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Sachiyo', 'Initials': 'S', 'LastName': 'Mitsunaga', 'Affiliation': 'Department of Dentistry and Oral and Maxillofacial Surgery, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagami', 'Affiliation': 'Department of Breast and Endocrine Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Moriyasu', 'Initials': 'M', 'LastName': 'Adachi', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kondo', 'Affiliation': 'Department of Breast and Endocrine Surgery, Nagoya City University Hospital, Nagoya, Japan.'}, {'ForeName': 'Yasuyuki', 'Initials': 'Y', 'LastName': 'Shibuya', 'Affiliation': 'Department of Dentistry and Oral and Maxillofacial Surgery, Nagoya City University Hospital, Nagoya, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': ""Department of Breast Surgical Oncology, St. Luke's International Hospital, Tokyo, Japan.""}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Naito', 'Affiliation': 'Department of Oral Epidemiology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kashiwabara', 'Affiliation': 'Department of Biostatistics, School of Public Health, the University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Toshinari', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Umeda', 'Affiliation': 'Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'Department of Breast and Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Yoshihide', 'Initials': 'Y', 'LastName': 'Ota', 'Affiliation': 'Department of Dentistry and Oral and Maxillofacial Surgery, Tokai University School of Medicine, Tokyo, Japan.'}]",The oncologist,['10.1634/theoncologist.2019-0382']
3076,32077706,"Patient, client, consumer, or service user? An empirical investigation into the impact of labels on stigmatizing attitudes.","OBJECTIVE


Currently there is no universally agreed upon language for those seeking psychiatric treatment, and labels commonly include patient, client, consumer, and service user. Although there is some research regarding preferences for label (Dickens & Picchioni, 2012), little is known about how people perceive an individual differently based on the label used. The current study examined whether specific labels were associated with more stigmatizing attitudes.
METHOD


Participants recruited through MTurk ( N  = 526) were randomized to read a vignette of a man named Harry, described as a patient, client, consumer, or service user with mental illness. After correctly recalling the label from the vignette, participants were assessed for stigmatizing attitudes toward Harry.
RESULTS


ANOVAs indicated a no main effects of label on stigmatizing attitudes. A number of variables (e.g., overall stigma, dangerousness, segregation, and distance) revealed a significant interaction between label and prior mental health treatment: For those who have sought prior mental health treatment, the term client may be more stigmatizing than other labels.
CONCLUSIONS AND IMPLICATIONS FOR PRACTICE


The current study did not find general differences in stigmatizing attitudes associated with mental health treatment label. Although preliminary, these findings suggest treatment labels may not significantly impact stigmatizing attitudes. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"RESULTS


ANOVAs indicated a no main effects of label on stigmatizing attitudes.",['Participants recruited through MTurk ( N  = 526'],[],"['overall stigma, dangerousness, segregation, and distance']",[],[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0010968', 'cui_str': 'Dangerousness'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}]",526.0,0.0509659,"RESULTS


ANOVAs indicated a no main effects of label on stigmatizing attitudes.","[{'ForeName': 'Melanie W', 'Initials': 'MW', 'LastName': 'Fischer', 'Affiliation': 'Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Annalee V', 'Initials': 'AV', 'LastName': 'Johnson-Kwochka', 'Affiliation': 'Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Ruth L', 'Initials': 'RL', 'LastName': 'Firmin', 'Affiliation': 'Brown University Medical School.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Sheehan', 'Affiliation': 'Lewis College of Human Sciences, Illinois Institute of Technology.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Corrigan', 'Affiliation': 'Lewis College of Human Sciences, Illinois Institute of Technology.'}, {'ForeName': 'Michelle P', 'Initials': 'MP', 'LastName': 'Salyers', 'Affiliation': 'Department of Psychology, Indiana University-Purdue University Indianapolis.'}]",Psychiatric rehabilitation journal,['10.1037/prj0000406']
3077,32073145,Endoscopic ossiculoplasty: Is there any edge over the microscopic technique?,"OBJECTIVES/HYPOTHESIS


To compare endoscopic ossiculoplasty with conventional microscopic technique in terms of postoperative hearing outcomes and complications.
STUDY DESIGN


Randomized controlled trial.
METHODS


One hundred eighteen patients diagnosed with ossicular chain discontinuity were randomly assigned into two groups, one undergoing endoscopic ossiculoplasty and the other undergoing ossiculoplasty by the microscopic technique, with the operating surgeon being same for both groups. The two groups were compared in terms of operative time, postoperative air-bone gap, mean air-bone gap closure, and incidence of complications. Teflon prostheses (partial ossicular chain replacement prosthesis [PORP] and total ossicular chain replacement prosthesis [TORP]) were used for reconstruction in all cases.
RESULTS


Endoscopic ossiculoplasty with PORP rendered a statistically significant mean postoperative air-bone gap and air-bone gap closure at 1 month when compared to that of microscopic PORP ossiculoplasty. However, there was no significant difference between the two techniques in terms of mean postoperative air-bone gap and air-bone gap closure at 3 and 6 months. In the TORP ossiculoplasty cases, there was no significant difference in mean postoperative air-bone gap and air-bone gap closure at 1, 3, and 6 months. In terms of operative time and incidence of complications, no statistical significance was found between the two groups.
CONCLUSIONS


Endoscopic ossiculoplasty appears to provide superior visualization and better early audiological outcome (in PORP ossiculoplasty cases) when compared to microscopic technique. However, long-term audiological outcomes and incidence of complications remain comparable.
LEVEL OF EVIDENCE


1 Laryngoscope, 130:797-802, 2020.",2020,"The two groups were compared in terms of operative time, postoperative air-bone gap, mean air-bone gap closure, and incidence of complications.",['One hundred eighteen patients diagnosed with ossicular chain discontinuity'],"['Teflon prostheses (partial ossicular chain replacement prosthesis', 'total ossicular chain replacement prosthesis [TORP', 'Endoscopic ossiculoplasty', 'endoscopic ossiculoplasty and the other undergoing ossiculoplasty by the microscopic technique', 'conventional microscopic technique']","['operative time, postoperative air-bone gap, mean air-bone gap closure, and incidence of complications', 'operative time and incidence of complications', 'mean postoperative air-bone gap and air-bone gap closure']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}]","[{'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0040477', 'cui_str': 'TORP'}, {'cui': 'C1261340', 'cui_str': 'Reconstruction of ossicular chain (procedure)'}, {'cui': 'C0205288', 'cui_str': 'Microscopic (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",118.0,0.0240088,"The two groups were compared in terms of operative time, postoperative air-bone gap, mean air-bone gap closure, and incidence of complications.","[{'ForeName': 'Arindam', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Otorhinolaryngology and Head Neck Surgery, Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'Sandipta', 'Initials': 'S', 'LastName': 'Mitra', 'Affiliation': 'Department of Otorhinolaryngology and Head Neck Surgery, Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'Debasish', 'Initials': 'D', 'LastName': 'Ghosh', 'Affiliation': 'Department of Otorhinolaryngology and Head Neck Surgery, Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}, {'ForeName': 'Arunabha', 'Initials': 'A', 'LastName': 'Sengupta', 'Affiliation': 'Department of Otorhinolaryngology and Head Neck Surgery, Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, India.'}]",The Laryngoscope,['10.1002/lary.28074']
3078,31776849,"Outcomes of a text message, Fitbit, and coaching intervention on physical activity maintenance among cancer survivors: a randomized control pilot trial.","PURPOSE


We aimed to determine the effect of a health coach, text message, and Fitbit intervention on moderate-to-vigorous physical activity (MVPA) maintenance in cancer survivors following a supervised exercise program compared to provision of a Fitbit alone.
METHODS


Participants were recruited during the last month of an exercise-based oncology rehabilitation program and randomly assigned to the full intervention (n = 34) or Fitbit-only control groups (n = 32). In total, 59 cancer survivors completed the program (81% female; mean age 61.4 ± 9.0). Group by time differences in accelerometer-measured MVPA was assessed using linear mixed models. Additionally, we examined mean weekly Fitbit-derived MVPA levels.
RESULTS


Intervention participants maintained weekly MVPA from pre- (295.7 ± 139.6) to post-intervention (322.0 ± 199.4; p = 0.37), whereas those in the Fitbit-only group had a significant decrease in MVPA (305.5 ± 181.1 pre vs 250.7 ± 166.5 post; p = 0.03, effect size 0.57). The intervention participants maintained recommended levels of MPVA for health benefits during the 8-week intervention, whereas the Fitbit-only control group did not.
CONCLUSIONS


The findings demonstrate that a remote intervention delivered through health coaching, text messages, and Fitbit can promote maintenance of MVPA after a structured program for cancer survivors. However, use of a Fitbit alone was not sufficient to prevent expected decline in MVPA. Additional research is warranted to examine long-term impacts and efficacy in a more diverse population of cancer survivors.
IMPLICATIONS FOR CANCER SURVIVORS


Use of a wearable tracker alone may not be sufficient for exercise maintenance among cancer survivors after transition to an independent program. Additional planning for relapse prevention is recommended.",2020,"RESULTS


Intervention participants maintained weekly MVPA from pre- (295.7 ± 139.6) to post-intervention (322.0 ± 199.4; p = 0.37), whereas those in the Fitbit-only group had a significant decrease in MVPA (305.5 ± 181.1 pre vs 250.7 ± 166.5 post; p = 0.03, effect size 0.57).","['59 cancer survivors completed the program (81% female; mean age 61.4 ± 9.0', 'Participants were recruited during the last month of an', 'cancer survivors']","['exercise-based oncology rehabilitation program and randomly assigned to the full intervention (n = 34) or Fitbit-only control groups', 'health coach, text message, and Fitbit intervention', 'text message, Fitbit, and coaching intervention', 'supervised exercise program']","['levels of MPVA for health benefits', 'MVPA', 'physical activity maintenance']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2317129', 'cui_str': 'Health coach'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086387', 'cui_str': 'Health Benefits'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",,0.0422907,"RESULTS


Intervention participants maintained weekly MVPA from pre- (295.7 ± 139.6) to post-intervention (322.0 ± 199.4; p = 0.37), whereas those in the Fitbit-only group had a significant decrease in MVPA (305.5 ± 181.1 pre vs 250.7 ± 166.5 post; p = 0.03, effect size 0.57).","[{'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Gell', 'Affiliation': 'Department of Rehabilitation and Movement Science, University of Vermont, 306B Rowell 106 Carrigan Drive, Burlington, VT, 05405, USA. nancy.gell@med.uvm.edu.'}, {'ForeName': 'Kristin W', 'Initials': 'KW', 'LastName': 'Grover', 'Affiliation': 'University of Vermont Cancer Center, Burlington, VT, USA.'}, {'ForeName': 'Liliane', 'Initials': 'L', 'LastName': 'Savard', 'Affiliation': 'Department of Rehabilitation and Movement Science, University of Vermont, 306B Rowell 106 Carrigan Drive, Burlington, VT, 05405, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dittus', 'Affiliation': 'University of Vermont Cancer Center, Burlington, VT, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-019-00831-4']
3079,31610549,Rivaroxaban Versus Vitamin K Antagonist in Antiphospholipid Syndrome: A Randomized Noninferiority Trial.,"Background


The potential role of new oral anticoagulants in antiphospholipid antibody syndrome (APS) remains uncertain.
Objective


To determine whether rivaroxaban is noninferior to dose-adjusted vitamin K antagonists (VKAs) for thrombotic APS.
Design


3-year, open-label, randomized noninferiority trial. (EU Clinical Trials Register: EUDRA [European Union Drug Regulatory Authorities] code 2010-019764-36).
Setting


6 university hospitals in Spain.
Participants


190 adults (aged 18 to 75 years) with thrombotic APS.
Intervention


Rivaroxaban (20 mg/d or 15 mg/d, according to renal function) versus dose-adjusted VKAs (target international normalized ratio, 2.0 to 3.0, or 3.1 to 4.0 in patients with a history of recurrent thrombosis).
Measurements


The primary efficacy outcome was the proportion of patients with new thrombotic events; the primary safety outcome was major bleeding. The prespecified noninferiority margin for risk ratio (RR) was 1.40. Secondary outcomes included time to thrombosis, type of thrombosis, changes in biomarker levels, cardiovascular death, and nonmajor bleeding.
Results


After 3 years of follow-up, recurrent thrombosis occurred in 11 patients (11.6%) in the rivaroxaban group and 6 (6.3%) in the VKA group (RR in the rivaroxaban group, 1.83 [95% CI, 0.71 to 4.76]). Stroke occurred more commonly in patients receiving rivaroxaban (9 events) than in those receiving VKAs (0 events) (corrected RR, 19.00 [CI, 1.12 to 321.9]). Major bleeding occurred in 6 patients (6.3%) in the rivaroxaban group and 7 (7.4%) in the VKA group (RR, 0.86 [CI, 0.30 to 2.46]). Post hoc analysis suggested an increased risk for recurrent thrombosis in rivaroxaban-treated patients with previous arterial thrombosis, livedo racemosa, or APS-related cardiac valvular disease.
Limitation


Anticoagulation intensity was not measured in the rivaroxaban group.
Conclusion


Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.
Primary Funding Source


Bayer Hispania.",2019,"Conclusion


Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.
","['Setting\n\n\n6 university hospitals in Spain', 'Participants\n\n\n190 adults (aged 18 to 75 years) with thrombotic APS', 'Antiphospholipid Syndrome']","['Rivaroxaban Versus Vitamin K Antagonist', 'vitamin K antagonists (VKAs', 'rivaroxaban', 'Rivaroxaban']","['risk ratio (RR', 'Major bleeding', 'Limitation\n\n\nAnticoagulation intensity', 'proportion of patients with new thrombotic events; the primary safety outcome was major bleeding', 'recurrent thrombosis', 'time to thrombosis, type of thrombosis, changes in biomarker levels, cardiovascular death, and nonmajor bleeding', 'Stroke']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0085278', 'cui_str': 'Antiphospholipid Antibody Syndrome'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",190.0,0.206485,"Conclusion


Rivaroxaban did not show noninferiority to dose-adjusted VKAs for thrombotic APS and, in fact, showed a non-statistically significant near doubling of the risk for recurrent thrombosis.
","[{'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Ordi-Ros', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Sáez-Comet', 'Affiliation': 'Miguel Servet Hospital, Zaragoza, Spain (L.S., M.P.).'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Pérez-Conesa', 'Affiliation': 'Miguel Servet Hospital, Zaragoza, Spain (L.S., M.P.).'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Vidal', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Riera-Mestre', 'Affiliation': 'Bellvitge University Hospital-IDIBELL, Barcelona, Spain (A.R.).'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Castro-Salomó', 'Affiliation': 'Sant Joan de Reus University Hospital, Reus, Spain (A.C.).'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Cuquet-Pedragosa', 'Affiliation': 'Granollers University Hospital, Granollers, Spain (J.C., V.O.).'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Ortiz-Santamaria', 'Affiliation': 'Granollers University Hospital, Granollers, Spain (J.C., V.O.).'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Mauri-Plana', 'Affiliation': 'Mataró Hospital, Mataró, Spain (M.M.).'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Solé', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}, {'ForeName': 'Josefina', 'Initials': 'J', 'LastName': 'Cortés-Hernández', 'Affiliation': ""Vall d'Hebrón Research Institute, Barcelona, Spain (J.O., X.V., C.S., J.C.).""}]",Annals of internal medicine,['10.7326/M19-0291']
3080,32072617,Effect of 6% hydroxyethyl starch 130/0.4 on kidney and haemostatic function in cardiac surgical patients: a randomised controlled trial.,"Whether third-generation hydroxyethyl starch solutions provoke kidney injury or haemostatic abnormalities in patients having cardiac surgery remains unclear. We tested the hypotheses that intra-operative administration of a third-generation starch does not worsen postoperative kidney function or haemostasis in cardiac surgical patients compared with human albumin 5%. This triple-blind, non-inferiority, clinical trial randomly allocated patients aged 40-85 who underwent elective aortic valve replacement, with or without coronary artery bypass grafting, to plasma volume replacement with 6% starch 130/0.4 vs. 5% human albumin. Our primary outcome was postoperative urinary neutrophil gelatinase-associated lipocalin concentrations, a sensitive and early marker of postoperative kidney injury. Secondarily, we evaluated urinary interleukin-18; acute kidney injury using creatinine RIFLE criteria, coagulation measures, platelet count and function. Non-inferiority (delta 15%) was assessed with correction for multiple comparisons. We enrolled 141 patients (69 starch, 72 albumin) as planned. Results of the primary analysis demonstrated that postoperative urine neutrophil gelatinase-associated lipocalin (median (IQR [range])) was slightly lower with hydroxyethyl starch (5 (1-68 [0-996]) ng.ml -1  ) vs. albumin (5 (2-74 [0-1604]) ng.ml -1  ), although not non-inferior [ratio of geometric means (95%CI) 0.91 (0.57, 1.44); p = 0.15] due to higher than expected variability. Urine interleukin-18 concentrations were reduced, but interleukin-18 and kidney injury were again not non-inferior. Of 11 individual coagulation measures, platelet count and function, nine were non-inferior to albumin. Two remaining measures, thromboelastographic R value and arachidonic acid-induced platelet aggregation, were clinically similar but with wide confidence intervals. Starch administration during cardiac surgery produced similar observed effects on postoperative kidney function, coagulation, platelet count and platelet function compared with albumin, though greater than expected variability and wide confidence intervals precluded the conclusion of non-inferiority. Long-term mortality and kidney function appeared similar between starch and albumin.",2020,Whether third-generation hydroxyethyl starch solutions provoke kidney injury or haemostatic abnormalities in patients having cardiac surgery remains unclear.,"['patients aged 40-85 who underwent', 'patients having cardiac surgery', 'cardiac surgical patients', '141 patients (69 starch, 72 albumin) as planned']","['hydroxyethyl starch solutions', 'elective aortic valve replacement, with or without coronary artery bypass grafting, to plasma volume replacement with 6% starch 130/0.4 vs. 5% human albumin', 'hydroxyethyl starch']","['postoperative urinary neutrophil gelatinase-associated lipocalin concentrations, a sensitive and early marker of postoperative kidney injury', 'urinary interleukin-18; acute kidney injury using creatinine RIFLE criteria, coagulation measures, platelet count and function', 'Urine interleukin-18 concentrations', 'Long-term mortality and kidney function', 'postoperative kidney function or haemostasis', 'postoperative kidney function, coagulation, platelet count and platelet function', 'postoperative urine neutrophil gelatinase-associated lipocalin (median (IQR [range', 'thromboelastographic R value and arachidonic acid-induced platelet aggregation', 'kidney and haemostatic function', 'haemostatic abnormalities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0020352', 'cui_str': 'hydroxyethylstarch'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0032127', 'cui_str': 'Blood Plasma Volume'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0304925', 'cui_str': 'Albumin Human, USP'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0035611', 'cui_str': 'Rifles'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0042037'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C1254881', 'cui_str': 'Platelet function'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1268820', 'cui_str': 'Arachidonic acid induced platelet aggregation'}, {'cui': 'C0019116', 'cui_str': 'Hemostasis'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]",141.0,0.397991,Whether third-generation hydroxyethyl starch solutions provoke kidney injury or haemostatic abnormalities in patients having cardiac surgery remains unclear.,"[{'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Duncan', 'Affiliation': 'Departments of Cardiothoracic Anesthesiology and Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Jia', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Soltesz', 'Affiliation': 'Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Leung', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'H O', 'Initials': 'HO', 'LastName': 'Yilmaz', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Mao', 'Affiliation': 'Departments of Quantitative Health Sciences and Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Timur', 'Affiliation': 'Department of Laboratory Medicine, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kottke-Marchant', 'Affiliation': 'Department of Pathology and Laboratory Administration, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Rogers', 'Affiliation': 'Department of Laboratory Medicine, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Departments of Quantitative Health Sciences and Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Ince', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Karimi', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yagar', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Trombetta', 'Affiliation': 'Department of Cardiothoracic Anesthesiology, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Sessler', 'Affiliation': 'Department of Outcomes Research, Cleveland Clinic, Cleveland, OH, USA.'}]",Anaesthesia,['10.1111/anae.14994']
3081,32072344,Clinical and microbiological effect of frequent subgingival air polishing on periodontal conditions: a split-mouth randomized controlled trial.,"The objective of this study was to evaluate the clinical effects of repeated subgingival debridement by air polishing during supportive periodontal therapy. A double-blind, randomized controlled trial of 6 months in duration was conducted on 19 recall patients who were previously treated for chronic periodontitis. Three sites with probing pocket depths (PPD) of 4-9 mm in each of the patients were randomly assigned to the following treatments: Glycine powder/air polishing every 30 days (group 1), glycine powder/air polishing at baseline and on day 90 (group 2), or water irrigation every 30 days (group 3). Clinical parameters were recorded and microbiological sampling was performed at 0, 90, and 180 days post-treatment. Subgingival samples were analyzed using real-time PCR methods for Porphyromonas gingivalis, Tannerella forsythia, and Treponema denticola. Between baseline and 90 days, group 1 showed significantly more PPD reduction compared to group 3 and no significant differences with group 2. Between baseline and 180 days, group 1 displayed a significant increase in clinical attachment level compared with group 3. No differences were observed among the groups in numbers of total bacteria or percentage of investigated bacteria at any time point. This study revealed that routine subgingival air polishing at 30-day intervals had significant clinical effects in moderately deep pockets in patients who underwent supportive periodontal therapy.",2020,"Between baseline and 90 days, group 1 showed significantly more PPD reduction compared to group 3 and no significant differences with group 2.","['19 recall patients who were previously treated for chronic periodontitis', 'patients who underwent supportive periodontal therapy']","['Glycine powder/air polishing every 30\xa0days (group 1), glycine powder/air polishing at baseline', 'subgingival debridement by air polishing', 'subgingival air polishing']","['numbers of total bacteria or percentage of investigated bacteria', 'clinical attachment level', 'PPD reduction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0017890', 'cui_str': 'Glycine'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C3873167', 'cui_str': 'Every 30 days'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0034131', 'cui_str': 'Purified Protein Derivative of Tuberculin'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",19.0,0.299144,"Between baseline and 90 days, group 1 showed significantly more PPD reduction compared to group 3 and no significant differences with group 2.","[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Sekino', 'Affiliation': 'Department of Periodontology, School of Life Dentistry at Tokyo, The Nippon Dental University, 1-9-20, Fujimi, Chiyoda-ku, Tokyo, Japan. sekino-s@tky.ndu.ac.jp.'}, {'ForeName': 'Tomohisa', 'Initials': 'T', 'LastName': 'Ogawa', 'Affiliation': 'Division of General Dentistry, The Nippon Dental University Hospital, Tokyo, Japan.'}, {'ForeName': 'Etsuko', 'Initials': 'E', 'LastName': 'Murakashi', 'Affiliation': 'Department of Periodontology, School of Life Dentistry at Tokyo, The Nippon Dental University, 1-9-20, Fujimi, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ito', 'Affiliation': 'Department of Periodontology, School of Life Dentistry at Tokyo, The Nippon Dental University, 1-9-20, Fujimi, Chiyoda-ku, Tokyo, Japan.'}, {'ForeName': 'Yukihiro', 'Initials': 'Y', 'LastName': 'Numabe', 'Affiliation': 'Department of Periodontology, School of Life Dentistry at Tokyo, The Nippon Dental University, 1-9-20, Fujimi, Chiyoda-ku, Tokyo, Japan.'}]",Odontology,['10.1007/s10266-020-00493-0']
3082,32069742,Contrasting short-term temperature effects on the profiling of metabolic and stress hormones in non-obese healthy adults: A randomized cross-over trial.,"The manifestation of elevated and sustained air temperature gradient profiles in urban dwellings represents an emerging planetary health phenomenon. There is currently limited evidence about the effect of elevated air temperatures on metabolic health. The aim of this work was to assess changes in metabolic and stress hormonal profiles during a short-term stay in a mountainous, climate-cooler setting against those observed in the urban setting. A prospective, randomized, 2 x 2 cross-over trial of non-obese healthy adults in urban and mountainous areas of a Mediterranean country (Cyprus) was set up during summer, under real-life conditions. The intervention was a short-term stay (mean ± SD: 7 ± 3 days) in a mountainous, climate-cooler setting (altitude range: 650-1200 m), being ~1-h drive away from the main urban centres of Cyprus. The primary endpoint was the change in metabolic hormones levels (leptin and adiponectin) and stress hormone levels (cortisol) between the two settings. Personal air and skin temperature sensors were deployed while biospecimen were collected in each setting. A total of 41 participants between 20 and 60 years old were enrolled and randomized during July 2018, of whom 39 received the allocated intervention, 8 were lost to follow up or excluded from analysis and a total of 31 participants were analysed. A significant leptin reduction (β = -0.255; 95% CI: -0.472, -0.038; p = 0.024) was observed for non-obese healthy adults during their short-term stay in the mountainous environment. The intervention effect on adiponectin or cortisol levels was not statistically significant (β = 0.058; 95% CI: -0.237, 0.353; p = 0.702), and (β = -0.026; 95% CI: -0.530, 0.478; p = 0.920), respectively. In additional analyses, daily max skin temperature surrogate measures were significantly associated with leptin levels (β = 0.34; 95% CI: 0.051, 0.633; p = 0.024). During summer season, a short-term stay in climatologically cooler areas improved the leptin levels of non-obese healthy adults who permanently reside in urban areas of a Mediterranean country. A larger sample is needed to confirm the trial findings that could provide the rationale for such public health interventions in climate-impacted urban areas of our planet.",2020,"The intervention effect on adiponectin or cortisol levels was not statistically significant (β = 0.058; 95% CI: -0.237, 0.353; p = 0.702), and (β = -0.026; 95% CI: -0.530, 0.478; p = 0.920), respectively.","['non-obese healthy adults', 'urban dwellings', 'non-obese healthy adults who permanently reside in urban areas of a Mediterranean country', '41 participants between 20 and 60 years old were enrolled and randomized during July 2018, of whom 39 received the allocated intervention, 8 were lost to follow up or excluded from analysis and a total of 31 participants were analysed', 'non-obese healthy adults in urban and mountainous areas of a Mediterranean country (Cyprus) was set up during summer, under real-life conditions']",[],"['adiponectin or cortisol levels', 'leptin reduction', 'Personal air and skin temperature sensors', 'daily max skin temperature surrogate measures', 'metabolic and stress hormonal profiles', 'leptin levels', 'change in metabolic hormones levels (leptin and adiponectin) and stress hormone levels (cortisol']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]",[],"[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0458083', 'cui_str': 'Hormonal (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}]",41.0,0.0881305,"The intervention effect on adiponectin or cortisol levels was not statistically significant (β = 0.058; 95% CI: -0.237, 0.353; p = 0.702), and (β = -0.026; 95% CI: -0.530, 0.478; p = 0.920), respectively.","[{'ForeName': 'Konstantinos C', 'Initials': 'KC', 'LastName': 'Makris', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus. Electronic address: konstantinos.makris@cut.ac.cy.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Konstantinou', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Perikkou', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Zdravic', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus.'}, {'ForeName': 'Costas A', 'Initials': 'CA', 'LastName': 'Christophi', 'Affiliation': 'Cyprus International Institute for Environmental and Public Health, Cyprus University of Technology, Limassol, Cyprus.'}]",Environmental research,['10.1016/j.envres.2019.109065']
3083,32069756,Transportation noise impairs cardiovascular function without altering sleep: The importance of autonomic arousals.,"AIMS


Chronic exposure to nocturnal transportation noise has been linked to cardiovascular disorders with sleep impairment as the main mediator. Here we examined whether nocturnal transportation noise affects the main stress pathways, and whether it relates to changes in the macro and micro structure of sleep.
METHODS AND RESULTS


Twenty-six young healthy participants (12 women, 24.6 ± 0.7 years, mean ± SE) spent five consecutive 24-h days and one last morning in the laboratory. The first (baseline) and last (recovery) nights comprised a quiet ambient scenario. In-between, four different noise scenarios (low/medium/high intermittent road or rail scenarios with an identical equivalent continuous sound level of 45 dB) were randomly presented during the 8-h nights. Participants felt more annoyed from the transportation noise scenarios compared to the quiet ambient scenario played back during the baseline and recovery nights (F 5,117  = 10.2, p < 0.001). Nocturnal transportation noise did not significantly impact polysomnographically assessed sleep macrostructure, blood pressure, nocturnal catecholamine levels and morning cytokine levels. Evening cortisol levels increased after sleeping with highly intermittent road noise compared to baseline (p = 0.002, noise effect: F 4,83  = 4.0, p = 0.005), a result related to increased cumulative duration of autonomic arousals during the noise nights (F 5,106  = 3.4, p < 0.001; correlation: r pearson  = 0.64, p = 0.006).
CONCLUSION


Under controlled laboratory conditions, highly intermittent nocturnal road noise exposure at 45 dB increased the cumulative duration of autonomic arousals during sleep and next-day evening cortisol levels. Our results indicate that, without impairing sleep macrostructure, nocturnal transportation noise of 45 dB is a physiological stressor that affects the hypothalamic-pituitary-adrenal axis during the following day in healthy young good sleepers.",2020,"Evening cortisol levels increased after sleeping with highly intermittent road noise compared to baseline (p = 0.002, noise effect: F 4,83  = 4.0, p = 0.005), a result related to increased cumulative duration of autonomic arousals during the noise nights (F 5,106  = 3.4, p < 0.001; correlation: r pearson  = 0.64, p = 0.006).
","['Twenty-six young healthy participants (12 women, 24.6\xa0±\xa00.7 years, mean\xa0±\xa0SE) spent five consecutive 24-h days and one last morning in the laboratory']",['Transportation noise'],"['cumulative duration of autonomic arousals', 'Evening cortisol levels', 'sleep macrostructure, blood pressure, nocturnal catecholamine levels and morning cytokine levels']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0028265', 'cui_str': 'Noise, Transportation'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0546632', 'cui_str': 'Catecholamine measurement (procedure)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",26.0,0.0203238,"Evening cortisol levels increased after sleeping with highly intermittent road noise compared to baseline (p = 0.002, noise effect: F 4,83  = 4.0, p = 0.005), a result related to increased cumulative duration of autonomic arousals during the noise nights (F 5,106  = 3.4, p < 0.001; correlation: r pearson  = 0.64, p = 0.006).
","[{'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Thiesse', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Switzerland.'}, {'ForeName': 'Franziska', 'Initials': 'F', 'LastName': 'Rudzik', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Switzerland.'}, {'ForeName': 'Jan F', 'Initials': 'JF', 'LastName': 'Kraemer', 'Affiliation': 'Department of Physics, Humboldt-Universität ZU Berlin, Germany.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Spiegel', 'Affiliation': 'WAKING Team, Lyon Neuroscience Research Center (CRNL) - INSERM U1028, CNRS UMR5292, University Claude Bernard Lyon 1, Lyon, France.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Leproult', 'Affiliation': 'Université libre de Bruxelles (ULB), Avenue F.D. Roosevelt 50, Bruxelles, Belgium.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Wessel', 'Affiliation': 'Department of Physics, Humboldt-Universität ZU Berlin, Germany.'}, {'ForeName': 'Reto', 'Initials': 'R', 'LastName': 'Pieren', 'Affiliation': 'Empa - Swiss Federal Laboratories for Materials Science and Technology, Duebendorf, Switzerland.'}, {'ForeName': 'Harris', 'Initials': 'H', 'LastName': 'Héritier', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Ikenna C', 'Initials': 'IC', 'LastName': 'Eze', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Foraster', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland; ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain; Blanquerna School of Health Science, Universitat Ramon Llull, Barcelona, Spain.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Garbazza', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Switzerland.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Vienneau', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Brink', 'Affiliation': 'Swiss Federal Office for the Environment, Bern, Switzerland.'}, {'ForeName': 'Jean Marc', 'Initials': 'JM', 'LastName': 'Wunderli', 'Affiliation': 'Empa - Swiss Federal Laboratories for Materials Science and Technology, Duebendorf, Switzerland.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Probst-Hensch', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Röösli', 'Affiliation': 'Swiss Tropical and Public Health Institute, Basel, Switzerland; University of Basel, Basel, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Cajochen', 'Affiliation': 'Centre for Chronobiology, Psychiatric Hospital of the University of Basel, Switzerland; Transfaculty Research Platform Molecular and Cognitive Neurosciences, University of Basel, Switzerland. Electronic address: Christian.Cajochen@upk.ch.'}]",Environmental research,['10.1016/j.envres.2019.109086']
3084,32071058,Assessment of Drug Resistance during Phase 2b Clinical Trials of Presatovir in Adults Naturally Infected with Respiratory Syncytial Virus.,"This study summarizes drug resistance analyses in 4 recent phase 2b trials of the respiratory syncytial virus (RSV) fusion inhibitor presatovir in naturally infected adults. Adult hematopoietic cell transplant (HCT) recipients, lung transplant recipients, or hospitalized patients with naturally acquired, laboratory-confirmed RSV infection were enrolled in 4 randomized, double-blind, placebo-controlled studies with study-specific presatovir dosing. Full-length RSV  F  sequences amplified from nasal swabs obtained at baseline and postbaseline were analyzed by population sequencing. Substitutions at RSV fusion inhibitor resistance-associated positions are reported. Genotypic analyses were performed on 233 presatovir-treated and 149 placebo-treated subjects. RSV F variant V127A was present in 8 subjects at baseline. Population sequencing detected treatment-emergent substitutions in 10/89 (11.2%) HCT recipients with upper and 6/29 (20.7%) with lower respiratory tract infection, 1/35 (2.9%) lung transplant recipients, and 1/80 (1.3%) hospitalized patients treated with presatovir; placebo-treated subjects had no emergent resistance-associated substitutions. Subjects with substitutions at resistance-associated positions had smaller decreases in viral load during treatment relative to those without, but they had similar clinical outcomes. Subject population type and dosing regimen may have influenced RSV resistance development during presatovir treatment. Subjects with genotypic resistance development had decreased virologic responses compared to those without genotypic resistance but had comparable clinical outcomes.",2020,"Subjects with substitutions at resistance-associated positions had smaller decreases in viral load during treatment relative to those without, but similar clinical outcomes.","['4 recent phase 2b trials of the respiratory syncytial virus (RSV) fusion inhibitor presatovir in naturally infected adults', 'adults naturally infected with respiratory syncytial virus', 'Adult hematopoietic cell transplant (HCT) recipients, lung transplant recipients, or hospitalized patients with naturally acquired, laboratory-confirmed RSV infection']","['placebo', 'presatovir; placebo']","['virologic responses', 'RSV resistance development', 'emergent resistance-associated substitutions', 'viral load']","[{'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C1275666', 'cui_str': 'Fusion inhibitor'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206152', 'cui_str': 'Cell Transplants'}, {'cui': 'C0024128', 'cui_str': 'Grafting, Lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}]",233.0,0.226378,"Subjects with substitutions at resistance-associated positions had smaller decreases in viral load during treatment relative to those without, but similar clinical outcomes.","[{'ForeName': 'Danielle P', 'Initials': 'DP', 'LastName': 'Porter', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA Danielle.Porter@gilead.com.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Perry', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Gossage', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Watkins', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Jason W', 'Initials': 'JW', 'LastName': 'Chien', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jordan', 'Affiliation': 'Gilead Sciences, Inc., Foster City, California, USA.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.02312-19']
3085,31409522,Perinatal outcomes in 521 gestations after fresh and frozen cycles: a secondary outcome of a randomized controlled trial comparing GnRH antagonist versus GnRH agonist protocols.,"RESEARCH QUESTION


Are perinatal outcomes different after treatment with the gonadotrophin-releasing hormone (GnRH) antagonist versus the long GnRH agonist protocol for IVF?
DESIGN


Perinatal outcomes were secondary outcomes in a large Phase IV, dual-centre, open-label, randomized controlled trial to compare GnRH antagonist and long GnRH agonist protocols in women <40 years undergoing their first assisted reproductive technology treatment. Women (n = 1050) were randomized in a ratio 1:1 from January 2009 to December 2013 and followed until December 2016. All fresh and frozen embryo transfer (FET) cycles from a single oocyte aspiration, resulting in a gestation (human chorionic gonadotrophin >10 IU/l) were included (n = 521). Data were analysed to compare preterm birth [PTB] (<37 weeks), very PTB (<32 weeks), low birthweight [LBW] (<2500 g) and very LBW (<1500 g) rates among singleton live births in GnRH antagonist versus agonist protocol.
RESULTS


Similar perinatal outcomes were found after both protocols. In singletons after fresh embryo transfer, mean gestational age at delivery was 39.1 ± 2.49 versus 39.3 ± 1.90 (P = 0.67) and very PTB rates 1.9% versus 0% (P = 0.17). Mean birthweight was 3264 ± 662 g in the antagonist and 3341 ± 562 g in the agonist group (P = 0.37). LBW was found in 12.4% versus 7% (P = 0.19) and very LBW in 2.9% versus 1% (P = 0.34). In FET cycles, the perinatal outcomes were similar. Small for gestational age and large for gestational age rates were similar in both protocols for singleton live births after fresh and FET.
CONCLUSIONS


Perinatal outcomes are similar after the GnRH antagonist versus GnRH agonist protocols for IVF. The choice of the GnRH analogue in ovarian stimulation should be based solely on optimizing the chance of pregnancy and not on risks in perinatal outcomes.",2019,"Small for gestational age and large for gestational age rates were similar in both protocols for singleton live births after fresh and FET.
","['521 gestations after fresh and frozen cycles', 'Mean birthweight was 3264\xa0±', '662\xa0g in the antagonist and 3341\xa0±', 'Women (n\u202f=\u202f1050) were randomized in a ratio 1:1 from January 2009 to December 2013 and followed until December 2016', 'in women <40 years undergoing their first assisted reproductive technology treatment']","['gonadotrophin-releasing hormone (GnRH) antagonist', 'All fresh and frozen embryo transfer (FET) cycles', 'GnRH antagonist versus GnRH agonist protocols', 'GnRH antagonist and long GnRH agonist protocols']","['mean gestational age at delivery', 'preterm birth [PTB', 'PTB rates', 'low birthweight [LBW', 'LBW']","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0872104', 'cui_str': 'Assisted Reproductive Technologies'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer (procedure)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",,0.143252,"Small for gestational age and large for gestational age rates were similar in both protocols for singleton live births after fresh and FET.
","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Tomás', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Centre of Infertility and Medically Assisted Reproduction, Hospital Garcia de Orta, Almada, Portugal. Electronic address: clautomas@gmail.com.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Toftager', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Løssl', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Bogstad', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Prætorius', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Copenhagen University Hospital Hvidovre, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zedeler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Copenhagen University Hospital Hvidovre, Denmark.'}, {'ForeName': 'Thue', 'Initials': 'T', 'LastName': 'Bryndorf', 'Affiliation': 'Department of Obstetrics and Gynaecology, Fertility Clinic, Copenhagen University Hospital Hvidovre, Denmark.'}, {'ForeName': 'Anders Nyboe', 'Initials': 'AN', 'LastName': 'Andersen', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2019.05.010']
3086,31362674,Effect of Levetiracetam on Cognitive Function and Clonic Seizure Frequency in Children with Epilepsy.,"OBJECTIVE


This study aimed to explore the clinical effect of levetiracetam in the treatment of children with epilepsy.
METHODS


136 children with epilepsy were selected from January 2017 to December 2017. According to the random number table method, they were divided into the experimental group and the conventional group, with 68 cases in each group. The conventional group was treated with valproate, while the experimental group was treated with levetiracetam. The effective rate, the cognitive function and the frequency of clonic seizures in the two groups were compared.
RESULTS


There was no significant difference in the total effective rate between the two groups (P>0.05). There was no significant difference in attention, executive ability, abstract and orientation scores between the two groups before treatment (P>0.05). After treatment, the focus of attention (106.54±6.56), executive ability (105.76±6.77), abstract and directional score (106.65±6.57) were significantly higher than that of the conventional group. The difference in the two groups was statistically significant (P<0.05). After 3 months of treatment, the frequency of myoclonic seizures (9.22±0.95) and the frequency of tonic-clonic seizures (11.68±1.36) were found to be significantly lower than those of the conventional group, and the difference between the two groups was statistically significant (P<0.05).
CONCLUSION


Levetiracetam is effective in the treatment of children with epilepsy. It can effectively improve the cognitive function of the patients, reduce the frequency of myoclonic seizures and tonic-clonic seizures, and has a high promotion value.",2019,"There was no significant difference in attention, executive ability, abstract and orientation scores between the two groups before treatment (P>0.05).","['136 children with epilepsy were selected from January 2017 to December 2017', 'children with epilepsy']","['valproate', 'Levetiracetam', 'levetiracetam']","['cognitive function and clonic seizure frequency', 'attention, executive ability, abstract and orientation scores', 'effective rate, the cognitive function and the frequency of clonic seizures', 'frequency of myoclonic seizures', 'frequency of tonic clonic seizures', 'concentration of attention (106.54±6.56), executive ability (105.76±6.77), abstract and directional score', 'cognitive function', 'total effective rate']","[{'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}]","[{'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0234535', 'cui_str': 'Clonic Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600678', 'cui_str': 'Abstracts'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C4317123', 'cui_str': 'Myoclonic Seizures'}, {'cui': 'C0494475', 'cui_str': 'Generalized Tonic-Clonic Seizures'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",136.0,0.0211517,"There was no significant difference in attention, executive ability, abstract and orientation scores between the two groups before treatment (P>0.05).","[{'ForeName': 'Shihao', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Genetic and Eugenics,Changsha Hospital for Maternal and Child Health Care, Changsha, Hunan, 410011, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Zhan', 'Affiliation': 'Department of Neurology, Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, Second Xiangya Hospital of Central South University, Changsha, Hunan, 410011, China.'}]",Current molecular medicine,['10.2174/1566524019666190729113321']
3087,32028501,Sensation of Pain Using Buffered Lidocaine for Infiltration Before Vulvar Biopsy: A Randomized Controlled Trial.,"OBJECTIVE


To evaluate the effects of buffered lidocaine on pain scores during vulvar biopsy.
METHODS


We conducted a double-blind, randomized controlled trial, using prefilled, sequentially numbered, randomized syringes to infiltrate either 3 mL of buffered or nonbuffered lidocaine before vulvar biopsy. The primary outcome was a pain score marked on a 100-mm visual analog scale during infiltration. Secondary outcomes included pain scores after the procedure and change from baseline to infiltration. Participants were recruited to detect a clinically meaningful 15-mm difference in pain scores between groups. Sample size was calculated based on the null hypothesis that the mean pain score would be the same in women treated with buffered lidocaine as in those treated with nonbuffered placebo based on prior studies. Categorical data were compared by Fisher exact test, and continuous data were compared between groups by t-test or Wilcoxon rank sum test.
RESULTS


From July 2015 to April 2018, 129 participants were randomized to one of two groups: nonbuffered lidocaine or buffered lidocaine. One hundred twenty-five were analyzed (nonbuffered n=62, buffered n=63). Four patients were excluded. The majority of participants were non-Hispanic white women with a mean age of 59 years. There was no difference in the primary outcome of pain during infiltration with a mean pain score of 35.8 mm in the buffered lidocaine group compared with 42.2 in the nonbuffered lidocaine group (mean difference -6.4; 95% CI -18.4 to 5.6; P=.3 by Wilcoxon rank sum test). There was also no difference in secondary outcomes of pain over the entire procedure (mean difference -0.3, 95% CI -9.7 to 9.2; P=.7) or change in pain from baseline to infiltration (mean difference -6.9, 95% CI -18.4 to 4.7; P=.2).
CONCLUSION


There was no difference in pain scores during vulvar biopsy infiltration between the buffered and nonbuffered lidocaine groups.
CLINICAL TRIAL REGISTRATION


ClinicalTrials.gov, NCT02698527.",2020,"There was no difference in pain scores during vulvar biopsy infiltration between the buffered and nonbuffered lidocaine groups.
","['One hundred twenty-five were analyzed (nonbuffered n=62, buffered n=63', 'participants were non-Hispanic white women with a mean age of 59 years', 'Before Vulvar Biopsy', 'before vulvar biopsy', 'From July 2015 to April 2018, 129 participants']","['lidocaine', 'Lidocaine', 'nonbuffered lidocaine or buffered lidocaine', 'nonbuffered lidocaine', 'nonbuffered placebo']","['mean pain score', 'change in pain', 'pain', 'pain during infiltration with a mean pain score', 'Sensation of Pain', 'pain score marked on a 100-mm visual analog scale during infiltration', 'pain scores']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1744618', 'cui_str': 'Biopsy of vulva (procedure)'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",129.0,0.657694,"There was no difference in pain scores during vulvar biopsy infiltration between the buffered and nonbuffered lidocaine groups.
","[{'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Villavicencio', 'Affiliation': ""Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, Michigan; and the Department of Obstetrics and Gynecology, the Program in Women's Oncology, Division of Research, Department of Obstetrics and Gynecology, and the Program in Women's Oncology, Department of Obstetrics and Gynecology, Women & Infants Hospital, Alpert Medical School of Brown University, Providence, Rhode Island.""}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Kulkarni', 'Affiliation': ''}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Luis', 'Affiliation': ''}, {'ForeName': 'Heidy', 'Initials': 'H', 'LastName': 'Mendez', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Raker', 'Affiliation': ''}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Cronin', 'Affiliation': ''}, {'ForeName': 'Katina', 'Initials': 'K', 'LastName': 'Robison', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003710']
3088,31482477,Sexual health and rehabilitation after ovarian suppression treatment (SHARE-OS): a clinical intervention for young breast cancer survivors.,"PURPOSE


Each year, thousands of young breast cancer (BC) patients confront the difficult decision to medically suppress ovarian function and undergo abrupt, premature menopause to reduce risk of cancer recurrence. Unlike natural menopause, young women undergoing ovarian suppression (OS) face severe and disruptive side effects. Profound sexual dysfunction is one of the most prevalent, distressing side effects of OS treatment. Unmanaged sexual dysfunction is also a primary predictor of non-adherence to this potentially life-saving treatment. We developed and tested a brief, psychosexual intervention targeted to manage sexual dysfunction and psychological distress after OS in young BC survivors.
METHODS


Twenty young BC survivors with sexual dysfunction received a single 4-h group intervention that included sexual health rehabilitation, body awareness exercises, and mindfulness-based cognitive therapy (MBCT) skills followed by a single tailored booster telephone call 1-month later. Assessment of female sexual function and psychological distress was completed at baseline and 2 months post-intervention.
RESULTS


Analyses examined changes pre- to post-intervention. Female sexual health improved significantly from baseline to follow-up (n = 19, p < 0.02). Anxiety was also significantly improved at the 2-month (p < 0.000) timepoint, compared with baseline 1. Moderate-to-large effect sizes were observed regarding changes in sexual function and psychological distress.
CONCLUSIONS


Significant improvements in sexual functioning and psychological distress were observed 2 months post-intervention.
IMPLICATIONS FOR CANCER SURVIVORS


These results demonstrate that delivery of a targeted intervention in brief, low-intensity group setting is a promising model for reducing distressing sexual dysfunction in young BC survivors on OS treatment.",2020,"Anxiety was also significantly improved at the 2-month (p < 0.000) timepoint, compared with baseline 1.","['Twenty young BC survivors with sexual dysfunction', 'young breast cancer survivors', 'FOR CANCER SURVIVORS', 'young BC survivors']","['single 4-h group intervention that included sexual health rehabilitation, body awareness exercises, and mindfulness-based cognitive therapy (MBCT) skills followed by a single tailored booster telephone call 1-month later', 'ovarian suppression treatment (SHARE-OS', 'psychosexual intervention']","['female sexual function and psychological distress', 'sexual dysfunction and psychological distress', 'sexual function and psychological distress', 'distressing sexual dysfunction', 'Anxiety', 'sexual functioning and psychological distress', 'Female sexual health']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder (disorder)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0563648', 'cui_str': 'Suppression treatment (regime/therapy)'}]","[{'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0549622', 'cui_str': 'Sexual disorder (disorder)'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}]",20.0,0.0214594,"Anxiety was also significantly improved at the 2-month (p < 0.000) timepoint, compared with baseline 1.","[{'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Bober', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA. Sharon_bober@dfci.harvard.edu.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Fine', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Recklitis', 'Affiliation': 'Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA, 02215, USA.'}]",Journal of cancer survivorship : research and practice,['10.1007/s11764-019-00800-x']
3089,31851556,Gemtuzumab Ozogamicin in  NPM1 -Mutated Acute Myeloid Leukemia: Early Results From the Prospective Randomized AMLSG 09-09 Phase III Study.,"PURPOSE


High CD33 expression in acute myeloid leukemia (AML) with mutated  NPM1  provides a rationale for the evaluation of gemtuzumab ozogamicin (GO) in this AML entity. We conducted a randomized trial to evaluate GO in combination with intensive induction and consolidation therapy in  NPM1 -mutated AML.
PATIENTS AND METHODS


Between May 2010 and September 2017, patients ≥ 18 years old and considered eligible for intensive therapy were randomly assigned up front for induction therapy with idarubicin, cytarabine, etoposide, and all- trans -retinoic acid with or without GO. The early ( P  = .02) primary end point of event-free survival (EFS) was evaluated 6 months after completion of patient recruitment.
RESULTS


Five hundred eighty-eight patients were randomly assigned (standard arm, n = 296; GO arm, n = 292). EFS in the GO arm was not significantly different compared with that in the standard arm (hazard ratio, 0.83; 95% CI, 0.65 to 1.04;  P  = .10). The early death rate during induction therapy was 10.3% in the GO arm and 5.7% in the standard arm ( P  = .05). Causes of death in both arms were mainly infections. The cumulative incidence of relapse (CIR) in patients achieving a complete remission (CR) or CR with incomplete hematologic recovery (CRi) was significantly reduced in the GO arm compared with the standard arm ( P  = .005), with no difference in the cumulative incidence of death ( P  = .80). Subgroup analysis revealed a significant beneficial effect of GO in female, younger (≤ 70 years), and  FLT3  internal tandem duplication-negative patients with respect to EFS and CIR.
CONCLUSION


The trial did not meet its early primary end point of EFS, mainly as a result of a higher early death rate in the GO arm. However, in patients achieving CR/CRi after induction therapy, significantly fewer relapses occurred in the GO compared with the standard arm.",2020,"EFS in the GO arm was not significantly different compared with that in the standard arm (hazard ratio, 0.83; 95% CI, 0.65 to 1.04;  P  = .10).","['acute myeloid leukemia (AML', 'Five hundred eighty-eight patients', 'Acute Myeloid Leukemia', 'Between May 2010 and September 2017, patients ≥ 18 years old and considered eligible for intensive therapy']","['intensive induction and consolidation therapy', 'induction therapy with idarubicin, cytarabine, etoposide, and all- trans -retinoic acid with or without GO']","['cumulative incidence of death', 'cumulative incidence of relapse (CIR', 'relapses', 'complete remission (CR) or CR with incomplete hematologic recovery (CRi', 'event-free survival (EFS', 'early death rate']","[{'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0040845', 'cui_str': 'retinoic acid'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",588.0,0.146388,"EFS in the GO arm was not significantly different compared with that in the standard arm (hazard ratio, 0.83; 95% CI, 0.65 to 1.04;  P  = .10).","[{'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Paschka', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Krzykalla', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Weber', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Silke', 'Initials': 'S', 'LastName': 'Kapp-Schwoerer', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Verena I', 'Initials': 'VI', 'LastName': 'Gaidzik', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Leis', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Fiedler', 'Affiliation': 'Department of Internal Medicine II, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kindler', 'Affiliation': 'Department of Hematology, Medical Oncology and Pneumology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schroeder', 'Affiliation': 'Department of Hematology, Oncology, and Clinical Immunology, University of Duesseldorf, Medical Faculty, Duesseldorf, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Mayer', 'Affiliation': 'Internal Medicine III, University Hospital of Bonn, Bonn, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lübbert', 'Affiliation': 'Klinik für Innere Medizin I, Universitätsklinikum Freiburg, Freiburg, Germany.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Wattad', 'Affiliation': 'Department of Hematology and Oncology, Hospital Essen-Werden, Essen, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Götze', 'Affiliation': 'Department of Internal Medicine III, University Hospital Klinikum Rechts der Isar, Munich, Germany.'}, {'ForeName': 'Heinz A', 'Initials': 'HA', 'LastName': 'Horst', 'Affiliation': 'Department of Internal Medicine II, University Hospital of Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Koller', 'Affiliation': 'Department of Internal Medicine III, Hanuschkrankenhaus Wien, Wien, Austria.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Wulf', 'Affiliation': 'Department of Hematology and Oncology, University Hospital of Göttingen, Göttingen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Schleicher', 'Affiliation': 'Klinikum der Landeshauptstadt Stuttgart, Stuttgart, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bentz', 'Affiliation': 'Department of Hematology and Oncology, Städtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Greil', 'Affiliation': 'IIIrd Medical Department, Paracelsus Medical University Salzburg; Salzburg Cancer Research Institute; and Cancer Cluster Salzburg, Salzburg, Austria.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hertenstein', 'Affiliation': 'Department of Hematology and Oncology, Klinikum Bremen Mitte, Bremen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Krauter', 'Affiliation': 'Department Hematology and Oncology, Braunschweig Municipal Hospital, Braunschweig, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Martens', 'Affiliation': 'Department of Hematology and Oncology, Klinikum am Gesundbrunnen, Heilbronn, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nachbaur', 'Affiliation': 'Department of Internal Medicine V, University Hospital of Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Maisun', 'Initials': 'M', 'LastName': 'Abu Samra', 'Affiliation': 'Department of Internal Medicine IV, University Hospital of Gießen, Gießen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Girschikofsky', 'Affiliation': 'Department of Hematology and Oncology, Hospital Elisabethinen Linz, Linz, Austria.'}, {'ForeName': 'Nadezda', 'Initials': 'N', 'LastName': 'Basara', 'Affiliation': 'Department of Hematology and Oncology, Malteser Krankenhaus St Franziskus-Hospital, Flensburg, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Benner', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Felicitas', 'Initials': 'F', 'LastName': 'Thol', 'Affiliation': 'Department of Hematology, Hemostaseology, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Department of Hematology, Hemostaseology, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Department of Hematology, Hemostaseology, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Konstanze', 'Initials': 'K', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01406']
3090,31829907,"Randomized Phase III Study of Ganetespib, a Heat Shock Protein 90 Inhibitor, With Docetaxel Versus Docetaxel in Advanced Non-Small-Cell Lung Cancer (GALAXY-2).","PURPOSE


Ganetespib, a highly potent heat shock protein 90 inhibitor, blocks multiple oncogenic pathways, resulting in antitumor activity. We evaluated the combination of ganetespib and docetaxel for second-line therapy of patients with advanced adenocarcinoma of the lung.
PATIENTS AND METHODS


In this international phase III trial, patients with stage IIIB or IV adenocarcinoma diagnosed > 6 months before study entry and 1 prior systemic therapy were randomly assigned (1:1) to ganetespib 150 mg/m 2  on days 1 and 15 with docetaxel 75 mg/m 2  on day 1 of a 21-day cycle or to docetaxel alone. The primary end point was overall survival (OS).
RESULTS


Of 677 enrolled patients, 335 were randomly assigned to ganetespib and docetaxel and 337 were assigned to docetaxel. The trial was stopped early as a result of futility at a planned interim analysis. The median OS time was 10.9 months (95% CI, 9.0 to 12.3 months) in the ganetespib and docetaxel arm compared with 10.5 months (95% CI, 8.6 to 12.2 months) in docetaxel arm (hazard ratio [HR], 1.11; 95% CI, 0.899 to 1.372;  P  = .329). Median progression-free survival was 4.2 months in the ganetespib and docetaxel arm and 4.3 months in the docetaxel arm (HR, 1.16; 95% CI, 0.96 to 1.403;  P  = .119). The addition of ganetespib did not improve outcomes compared with docetaxel alone for any secondary end point, including survival in the elevated lactate dehydrogenase or EGFR and ALK wild-type populations. The most common grade 3 or 4 adverse event in both arms was neutropenia (30.9% with ganetespib and docetaxel  v  25% with docetaxel).
CONCLUSION


The addition of ganetespib to docetaxel did not result in improved survival for salvage therapy of patients with advanced-stage lung adenocarcinoma.",2020,"The addition of ganetespib did not improve outcomes compared with docetaxel alone for any secondary end point, including survival in the elevated lactate dehydrogenase or EGFR and ALK wild-type populations.","['Advanced Non-Small-Cell Lung Cancer (GALAXY-2', 'patients with advanced-stage lung adenocarcinoma', 'patients with stage IIIB or IV adenocarcinoma diagnosed > 6 months before study entry and 1 prior systemic therapy', '677 enrolled patients', 'patients with advanced adenocarcinoma of the lung']","['docetaxel', 'docetaxel alone', 'ganetespib and docetaxel', 'Ganetespib', 'Docetaxel Versus Docetaxel', 'ganetespib 150 mg/m 2  on days 1 and 15 with docetaxel']","['overall survival (OS', 'survival', 'Median progression-free survival', 'neutropenia', 'median OS time']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0282063', 'cui_str': 'Galaxies'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of Lung'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0024109', 'cui_str': 'Lung'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C3467824'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",677.0,0.0704499,"The addition of ganetespib did not improve outcomes compared with docetaxel alone for any secondary end point, including survival in the elevated lactate dehydrogenase or EGFR and ALK wild-type populations.","[{'ForeName': 'Rathi N', 'Initials': 'RN', 'LastName': 'Pillai', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fennell', 'Affiliation': 'University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Kovcin', 'Affiliation': 'Clinical Hospital Centre Bežanijska Beograd, Belgrade, Serbia.'}, {'ForeName': 'Tudor-Eliade', 'Initials': 'TE', 'LastName': 'Ciuleanu', 'Affiliation': 'Prof Dr Ion Chiricuţă Institute of Oncology and Universitatea de Medicină şi Farmacie Iuliu Hatiegan, Cluj-Napoca, Romania.'}, {'ForeName': 'Rodryg', 'Initials': 'R', 'LastName': 'Ramlau', 'Affiliation': 'Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Kowalski', 'Affiliation': 'Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schenker', 'Affiliation': 'University of Medicine and Pharmacy Craiova, Craiova, Romania.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Yalcin', 'Affiliation': 'Synta Pharmaceuticals, West Conshohocken, PA.'}, {'ForeName': 'Florentina', 'Initials': 'F', 'LastName': 'Teofilovici', 'Affiliation': 'Synta Pharmaceuticals, West Conshohocken, PA.'}, {'ForeName': 'Vojo M', 'Initials': 'VM', 'LastName': 'Vukovic', 'Affiliation': 'Synta Pharmaceuticals, West Conshohocken, PA.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00816']
3091,31916142,Intimate Partner Violence Against Low-Income Women in Mexico City and Associations with Child School Attendance: A Latent Class Analysis Using Cross-sectional Data.,"INTRODUCTION


Few studies have investigated how intimate partner violence (IPV), and patterns of IPV experiences, may impact children's school attendance in low- and middle-income countries.
METHODS


Using baseline data from a sub-sample of 659 women in Mexico City enrolled in a randomized controlled trial who reported having a child under age 18 and in school, multilevel latent class analysis (LCA) was used to classify women based on their reported IPV experiences. Multilevel risk regression analyses examined associations between latent class membership and IPV-related disruptions in children's schooling. Latent classes were identified in a prior study.
RESULTS


Overall, 23.3% of women reported their child's school attendance was disrupted due to IPV. LCA identified four distinct classes of IPV experiences: Low Physical and Sexual Violence (39.1%); Low Physical and High Sexual Violence class (14.8%), High Physical and Low Sexual Violence and Injuries (36.5%); and High Physical and Sexual Violence and Injuries (9.6%). Compared with women in the Low Physical and Sexual Violence class, women in the High Physical and Sexual Violence and Injuries class and women in the High Physical and Low Sexual Violence and Injuries class were at greater risk of IPV disrupting children's school attendance (ARR 3.39, 95% CI 2.34, 4.92; ARR 2.22, 95% CI 1.54, 3.19, respectively). No other statistically significant associations emerged.
DISCUSSION


High disruptions in children's school attendance due to IPV were reported and were differentially related to patterns of IPV experiences. Findings underscore the need to understand underlying mechanisms. Future work integrating both violence against women and violence against children is needed.",2020,"DISCUSSION


High disruptions in children's school attendance due to IPV were reported and were differentially related to patterns of IPV experiences.","[""children's schooling"", 'violence against women and violence against children', 'Using baseline data from a sub-sample of 659 women in Mexico City enrolled in a randomized controlled trial who reported having a child under age 18 and in school, multilevel latent class analysis (LCA) was used to classify women based on their reported IPV experiences', 'Intimate Partner Violence Against Low-Income Women in Mexico City and Associations with Child School Attendance']",['LCA'],"['High Physical and Low Sexual Violence and Injuries', 'High Physical and Sexual Violence and Injuries', 'Low Physical and High Sexual Violence class', 'Physical and Sexual Violence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4704739', 'cui_str': 'Latent Variable Modeling'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0237484', 'cui_str': 'School attendance (observable entity)'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3489576', 'cui_str': 'Sexual Violence'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]",659.0,0.0256355,"DISCUSSION


High disruptions in children's school attendance due to IPV were reported and were differentially related to patterns of IPV experiences.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Scolese', 'Affiliation': 'Department of Global and Community Health, College of Health and Human Services, George Mason University, Fairfax, VA, USA. ascolese@masonlive.gmu.edu.'}, {'ForeName': 'Tiara C', 'Initials': 'TC', 'LastName': 'Willie', 'Affiliation': 'Warren Alpert Medical School of Brown University, Providence, RI, USA.'}, {'ForeName': 'Kathryn L', 'Initials': 'KL', 'LastName': 'Falb', 'Affiliation': 'International Rescue Committee, New York City, NY, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Sipsma', 'Affiliation': 'Benedictine University, Lisle, IL, USA.'}, {'ForeName': 'Paola Abril', 'Initials': 'PA', 'LastName': 'Campos', 'Affiliation': 'Department of Social and Behavioral Sciences, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Claudia Diaz', 'Initials': 'CD', 'LastName': 'Olavarrieta', 'Affiliation': 'National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Jhumka', 'Initials': 'J', 'LastName': 'Gupta', 'Affiliation': 'Department of Global and Community Health, College of Health and Human Services, George Mason University, Fairfax, VA, USA.'}]",Maternal and child health journal,['10.1007/s10995-020-02877-8']
3092,31548616,Effect of self-initiated and fully-automated self-measurement on blood pressure.,"Self-measurement of blood pressure (BP) is regularly used to diagnose hypertension and to monitor BP at home. We recently showed that self-measurement of BP may elicit a pressor or 'auto-cuff' response. In this study we examined whether the pressor response is different between self-initiated and fully-automated BP measurement. We performed two randomized crossover studies in outpatients visiting a hypertension clinic. The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography. The second cohort consisted of 120 patients who performed three self-initiated and three fully-automated BP measurements. In the first cohort (mean age 61.2 ± 10.4 years, mean office BP 142.0 ± 19.9/82.5 ± 12.2 mmHg, 36.7% female) average systolic and diastolic BP increased by 7.3 ± 8.5/3.3 ± 4.0 mmHg in the group with self-initiated BP measurements, while BP increased by 3.3 ± 6.3/1.4 ± 3.0 mmHg during fully-automated measurements (p = 0.002/p = 0.002 for difference between groups). The higher BP increase during self-initiated BP measurements resulted from an increase in heart rate and cardiac output. In the second cohort (mean age 58.0 ± 14.1 years, mean office BP 153.6 ± 23.8/86.3 ± 14.0 mmHg, 44.1% female) self-initiated BP measurement resulted in a 2.1 ± 6.8/0.9 ± 4.0 mmHg higher systolic and diastolic BP compared with fully-automated self-measurement (p = 0.001/0.018). In conclusion, our findings suggest that self-initiated BP measurement using a fully-automated method results in a more reliable BP compared with a self-initiated semi-automated method by attenuating the auto-cuff response. These findings may have implications for the self-measurement of BP.",2020,"The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography.","['outpatients visiting a hypertension clinic', '120 patients who performed three self-initiated and three fully-automated BP measurements', 'In the second cohort (mean age 58.0\u2009±\u200914.1 years, mean office BP 153.6\u2009±\u200923.8/86.3\u2009±\u200914.0\u2009mmHg, 44.1% female']",['self-initiated and fully-automated self-measurement'],"['blood pressure', 'systolic and diastolic BP', 'heart rate and cardiac output', 'pressor response', 'self-initiated BP measurement', 'Self-measurement of blood pressure (BP']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3715181', 'cui_str': 'Hypertension clinic (environment)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",52.0,0.024403,"The first cohort of 52 participants performed six unattended self-initiated and six fully-automated BP measurements, while continuously monitoring BP and central haemodynamics using finger photoplethysmography.","[{'ForeName': 'Rosanne T', 'Initials': 'RT', 'LastName': 'Berkhof', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Katia', 'Initials': 'K', 'LastName': 'Gazzola', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Bert-Jan H', 'Initials': 'BH', 'LastName': 'van den Born', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC location Academic Medical Center, Amsterdam, The Netherlands. b.j.vandenborn@amsterdamumc.nl.'}]",Journal of human hypertension,['10.1038/s41371-019-0256-1']
3093,31619393,"A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study.","OBJECTIVE


Topical oxygen has been used for the treatment of chronic wounds for more than 50 years. Its effectiveness remains disputed due to the limited number of robust high-quality investigations. The aim of this study was to assess the efficacy of multimodality cyclical pressure Topical Wound Oxygen (TWO2) home care therapy in healing refractory diabetic foot ulcers (DFUs) that had failed to heal with standard of care (SOC) alone.
RESEARCH DESIGN AND METHODS


Patients with diabetes and chronic DFUs were randomized (double-blind) to either active TWO2 therapy or sham control therapy-both in addition to optimal SOC. The primary outcome was the percentage of ulcers in each group achieving 100% healing at 12 weeks. A group sequential design was used for the study with three predetermined analyses and hard stopping rules once 73, 146, and ultimately 220 patients completed the 12-week treatment phase.
RESULTS


At the first analysis point, the active TWO2 arm was found to be superior to the sham arm, with a closure rate of 41.7% compared with 13.5%. This difference in outcome produced an odds ratio (OR) of 4.57 (97.8% CI 1.19, 17.57),  P  = 0.010. After adjustment for University of Texas Classification (UTC) ulcer grade, the OR increased to 6.00 (97.8% CI 1.44, 24.93),  P  = 0.004. Cox proportional hazards modeling, also after adjustment for UTC grade, demonstrated >4.5 times the likelihood to heal DFUs over 12 weeks compared with the sham arm with a hazard ratio of 4.66 (97.8% CI 1.36, 15.98),  P  = 0.004. At 12 months postenrollment, 56% of active arm ulcers were closed compared with 27% of the sham arm ulcers ( P  = 0.013).
CONCLUSIONS


This sham-controlled, double-blind randomized controlled trial demonstrates that, at both 12 weeks and 12 months, adjunctive cyclical pressurized TWO2 therapy was superior in healing chronic DFUs compared with optimal SOC alone.",2020,"Cox proportional hazards modeling, also after adjustment for UTC grade, demonstrated >4.5 times the likelihood to heal DFUs over 12 weeks compared with the sham arm with a hazard ratio of 4.66 (97.8% CI 1.36, 15.98),  P  = 0.004.","['Patients with diabetes and chronic DFUs', 'Chronic Diabetic Foot Ulcers', 'chronic wounds for more than 50 years', 'healing refractory diabetic foot ulcers (DFUs) that had failed to heal with standard of care (SOC) alone']","['Placebo', 'active TWO2 therapy or sham control therapy-both in addition to optimal SOC', 'Cyclical Topical Wound Oxygen Therapy', 'adjunctive cyclical pressurized TWO2 therapy', 'multimodality cyclical pressure Topical Wound Oxygen (TWO2) home care therapy']","['percentage of ulcers', 'heal DFUs', 'healing chronic DFUs', 'closure rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer (disorder)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439596', 'cui_str': 'Cyclic (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}]","[{'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}]",220.0,0.595525,"Cox proportional hazards modeling, also after adjustment for UTC grade, demonstrated >4.5 times the likelihood to heal DFUs over 12 weeks compared with the sham arm with a hazard ratio of 4.66 (97.8% CI 1.36, 15.98),  P  = 0.004.","[{'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Frykberg', 'Affiliation': 'Diabetic Foot Consultants, Midwestern University, Glendale, AZ rgfdpm@diabeticfoot.net.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Franks', 'Affiliation': 'Centre for Research and Implementation of Clinical Practice, London, U.K.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Edmonds', 'Affiliation': ""King's College Hospital, London, U.K.""}, {'ForeName': 'Jonathan N', 'Initials': 'JN', 'LastName': 'Brantley', 'Affiliation': 'McGuire Veterans Affairs Medical Center, Richmond, VA.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Téot', 'Affiliation': 'Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Wild', 'Affiliation': 'Medical Center Dessau, Brandenburg Medical School Theodor Fontane, Dessau, Germany.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Garoufalis', 'Affiliation': 'Edward Hines Jr. VA Hospital, Chicago, IL.'}, {'ForeName': 'Aliza M', 'Initials': 'AM', 'LastName': 'Lee', 'Affiliation': 'Salem Veterans Affairs Medical Center, Salem, VA.'}, {'ForeName': 'Janette A', 'Initials': 'JA', 'LastName': 'Thompson', 'Affiliation': 'Washington DC Veterans Affairs Medical Center, Washington, DC.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Reach', 'Affiliation': 'Hôpital Avicenne and Paris 13 University, Bobigny, France.'}, {'ForeName': 'Cyaandi R', 'Initials': 'CR', 'LastName': 'Dove', 'Affiliation': 'Advanced Foot & Ankle Center, Las Vegas, NV.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Lachgar', 'Affiliation': 'Hôpital Simone Veil, Eaubonne, Paris, France.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Grotemeyer', 'Affiliation': 'Hôpitaux Robert Schuman - Hôpital Kirchberg, Luxembourg City, Luxembourg.'}, {'ForeName': 'Sophie C', 'Initials': 'SC', 'LastName': 'Renton', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-0476']
3094,32060547,"When, How, & Where Tobacco Initiation and Relapse Occur During U.S. Air Force Technical Training.","INTRODUCTION


Military personnel are at high risk for tobacco use, particularly during the first year of military service. Technical Training follows an 8½ week tobacco ban during basic military training and is a vulnerable time for personnel to both reinitiate and initiate tobacco use. Thus, this can be a crucial time to promote tobacco policies and interventions. However, there is limited research examining when, how, and where personnel access tobacco during the first year of service, particularly among users of newer products (eg, electronic cigarettes[e-cigarettes]). Thus, the purpose of the current study is to explore the timing, source, and location of tobacco use during Technical Training across all types of products. Furthermore, this study will examine differences in demographic characteristics and prior tobacco history in relationship to these tobacco behaviors.
MATERIALS AND METHODS


Participants were U.S. Air Force recruits completing Technical Training (2017-2018). Protocol was approved by the Institutional Review Board at the 59th Medical Wing of the U.S. Air Force. During the first week of Technical Training, Airmen were consented to participate in the study and completed a questionnaire about demographics and tobacco use history. Next, Airmen were randomized to receive one of three tobacco prevention interventions as part of military training. At a 3-month follow-up, during the last week of Technical Training, consented participants completed a questionnaire about current tobacco use. Airmen reported when (ie, first month vs. after), how (ie, ""bummed"" from another airman, bought on or off base, received from the internet or event), and where (ie, designated smoking areas on base, off base, bar or club, friend's house, cigar lounge, hookah bar, or vape shop) they used tobacco during Technical Training. Descriptive statistics were used to examine these behaviors across all tobacco products. Additionally, Wilcoxon-Mann-Whitney and Kruskal-Wallis tests compared differences in demographic characteristics and baseline tobacco use in relationship to these tobacco behaviors.
RESULTS


No significant differences were found when comparing prior users and first-time users in relationship to tobacco behaviors during Technical Training; however, significant differences in educational background and age were found in regard to the source and location of tobacco use. Additionally, how and where Airmen first used tobacco during Technical Training differed across products. Cigarettes and smokeless tobacco were equally likely to be bought on or off base and most commonly first used at a designated smoking area on base. However, e-cigarettes, cigarillos/little cigars, and hookah were more likely to be bought off base, and first used at a specialty store (ie, vape shop, hookah bar, or cigar lounge).
CONCLUSIONS


Tobacco use behaviors during Technical Training differed depending on the type of product. Specifically, new and emerging products were more likely to be bought off base and first used at a specialty store. Thus, military polices regulating on base tobacco pricing might not reduce the growing prevalence of e-cigarettes. Future policies might consider addressing the density of off-base tobacco retailers to reduce the high rates of tobacco use in this population.",2020,"No significant differences were found when comparing prior users and first-time users in relationship to tobacco behaviors during Technical Training; however, significant differences in educational background and age were found in regard to the source and location of tobacco use.",['Participants were U.S. Air Force recruits completing Technical Training (2017-2018'],['tobacco prevention interventions as part of military training'],['Tobacco Initiation and Relapse Occur'],"[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",,0.0301639,"No significant differences were found when comparing prior users and first-time users in relationship to tobacco behaviors during Technical Training; however, significant differences in educational background and age were found in regard to the source and location of tobacco use.","[{'ForeName': 'Margaret Celice', 'Initials': 'MC', 'LastName': 'Fahey', 'Affiliation': 'Department of Psychology; 400 Innovation Drive, Memphis, TN 38111, USA.'}, {'ForeName': 'G Wayne', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Timothy L', 'Initials': 'TL', 'LastName': 'McMurry', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Klesges', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tubman', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Krukowski', 'Affiliation': 'University of Tennessee Health Science Center, Department of Preventive Medicine; 66 N Pauline Street Memphis, TN 38163, USA.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Little', 'Affiliation': 'University of Virginia School of Medicine; Center for Addiction and Prevention Research; 560 Ray C. Hunt Drive, Charlottesville, VA 22908, USA.'}]",Military medicine,['10.1093/milmed/usaa016']
3095,31182355,Intrauterine insemination: simultaneous with or 36 h after HCG? A randomized clinical trial.,"RESEARCH QUESTION


Does intrauterine insemination (IUI) carried out simultaneously with HCG triggering ('simultaneous IUI') increase the ongoing pregnancy rate compared with IUI 32-36 h after HCG triggering ('regular IUI')?
STUDY DESIGN


An open-label randomized clinical trial was conducted in seven Dutch fertility clinics. One hundred and sixty-six couples were randomized to receive simultaneous IUI and 208 couples to receive regular IUI. Treatment was allocated using a computer-based randomization algorithm using sealed opaque envelopes. Data were analysed according to the intention-to-treat principle. Couples with unexplained or mild-to-moderate male factor subfertility were eligible. Exclusion criteria were female age 42 years or older, female body mass index 35 kg/m 2  or over, double-sided tubal pathology or severe male factor subfertility. Mild ovarian stimulation was carried out by subcutaneous FSH self-administration. 'Simultaneous IUI' was carried out at the point of HCG triggering for ovulation. 'Regular IUI' was carried out 32-36 h after HCG triggering.
RESULTS


The cumulative ongoing pregnancy rate after a maximum of four cycles was 26.2% for simultaneous IUI (43 ongoing pregnancies) and 33.7% for regular IUI (70 ongoing pregnancies) (RR 0.78 95% CI 0.57 to 1.07). Ongoing pregnancy rates per cycle in the simultaneous IUI group were 6.8%, 10.5%, 9.5% and 7.4% for the first, second, third and fourth IUI cycle. In the regular IUI group, ongoing pregnancy rates were 8.3%, 16.4%, 13.5% and 9.0% for the first, second, third and fourth IUI cycle.
CONCLUSIONS


This multicentre randomized controlled trial did not demonstrate that IUI carried out at the point of HCG triggering increases pregnancy rates compared with IUI carried out around the time of ovulation.",2019,This multicentre randomized controlled trial did not demonstrate that IUI carried out at the point of HCG triggering increases pregnancy rates compared with IUI carried out around the time of ovulation.,"['Couples with unexplained or mild-to-moderate male factor subfertility', 'seven Dutch fertility clinics', 'and 208 couples to receive', 'Exclusion criteria were female age 42 years or older, female body mass index 35 kg/m 2  or over, double-sided tubal pathology or severe male factor subfertility', 'One hundred and sixty-six couples']","['simultaneous IUI', 'regular IUI', 'HCG']","['Ongoing pregnancy rates per cycle', 'cumulative ongoing pregnancy rate', 'pregnancy rate', 'ongoing pregnancy rates', 'pregnancy rates']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0729353', 'cui_str': 'Sub-Fertility'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0015895', 'cui_str': 'Fecundity'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C1141639', 'cui_str': 'Human Chorionic Gonadotropin'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}]",166.0,0.231163,This multicentre randomized controlled trial did not demonstrate that IUI carried out at the point of HCG triggering increases pregnancy rates compared with IUI carried out around the time of ovulation.,"[{'ForeName': 'Odette E', 'Initials': 'OE', 'LastName': 'Rijsdijk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maastricht University Medical Centre+, PO Box 5800, AZ Maastricht 6202, the Netherlands. Electronic address: odetterijsdijk@hotmail.com.'}, {'ForeName': 'Astrid E', 'Initials': 'AE', 'LastName': 'Cantineau', 'Affiliation': 'Department of Obstetrics and Gynaecology, University Medical Centre Groningen, the Netherlands.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Bourdrez', 'Affiliation': 'Department of Obstetrics and Gynaecology, VieCuri Medical Centre Venlo, the Netherlands.'}, {'ForeName': 'Tanja P', 'Initials': 'TP', 'LastName': 'Gijsen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Elkerliek Hospital Helmond, the Netherlands.'}, {'ForeName': 'Ed T', 'Initials': 'ET', 'LastName': 'Gondrie', 'Affiliation': 'Department of Obstetrics and Gynaecology, Zuyderland Hospital Heerlen/Sittard, the Netherlands.'}, {'ForeName': 'Odette', 'Initials': 'O', 'LastName': 'Sprengers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Laurentius Hospital Roermond, the Netherlands.'}, {'ForeName': 'Francis P', 'Initials': 'FP', 'LastName': 'Vrouenraets', 'Affiliation': 'Department of Obstetrics and Gynaecology, Zuyderland Hospital Heerlen/Sittard, the Netherlands.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Donners', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maastricht University Medical Centre+, PO Box 5800, AZ Maastricht 6202, the Netherlands.'}, {'ForeName': 'Johannes L', 'Initials': 'JL', 'LastName': 'Evers', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maastricht University Medical Centre+, PO Box 5800, AZ Maastricht 6202, the Netherlands.'}, {'ForeName': 'Luc J', 'Initials': 'LJ', 'LastName': 'Smits', 'Affiliation': 'Department of Epidemiology, Maastricht University, the Netherlands.'}, {'ForeName': 'Janneke E', 'Initials': 'JE', 'LastName': 'den Hartog', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maastricht University Medical Centre+, PO Box 5800, AZ Maastricht 6202, the Netherlands.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2019.03.208']
3096,31022311,A randomized controlled trial of adjuvant mitomycin-c in endoscopic surgery for laryngotracheal stenosis.,"OBJECTIVES/HYPOTHESIS


Topical mitomycin-C (MMC) application is a commonly accepted adjuvant therapy in the surgical treatment for laryngotracheal stenosis (LTS). However, the efficacy of MMC has not been examined in a prospective, randomized clinical trial in humans. We aimed to examine the efficacy of MMC in the treatment of LTS patients as compared to a placebo-controlled group.
STUDY DESIGN


Prospective, randomized, double-blind, placebo-controlled clinical trial.
METHODS


Fifteen patients with LTS were enrolled in a 24-month trial and randomized into one of two groups: 1) endoscopic surgical treatment with topical application of MMC or 2) endoscopic surgical treatment with topical application of saline. Postoperatively, patients were evaluated at standardized intervals with a symptom questionnaire and spirometry. Subsequent surgery was performed as needed based on relapse of stenosis on exam and patient-reported symptom severity.
RESULTS


The average interval between surgical treatments was 17.9 months in the placebo group and 17.4 months in the MMC group (P = .95). There was no difference in magnitude of peak inspiratory flow (PIF) improvement between groups. The average magnitude of PIF change was 1.3 L/sec and 1.1 L/sec for the placebo and MMC groups, respectively (P = .64). Similarly, there was no difference in magnitude of symptom improvement or duration of symptom improvement between the two groups.
CONCLUSIONS


This prospective, randomized. double-blind. placebo-controlled trial suggests that the use of MMC as a topical adjuvant therapy has no additional benefit in the endoscopic surgical management of LTS. Further study is needed.
LEVEL OF EVIDENCE


1b Laryngoscope, 130:706-711, 2020.",2020,There was no difference in magnitude of peak inspiratory flow (PIF) improvement between groups.,"['Fifteen patients with LTS', 'endoscopic surgery for laryngotracheal stenosis', 'laryngotracheal stenosis (LTS']","['placebo', 'MMC', 'endoscopic surgical treatment with topical application of MMC or 2) endoscopic surgical treatment with topical application of saline', 'Topical mitomycin-C (MMC) application', 'adjuvant mitomycin-c']","['magnitude of peak inspiratory flow (PIF) improvement', 'average interval', 'PIF change', 'magnitude of symptom improvement or duration of symptom improvement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282493', 'cui_str': 'Surgical Procedures, Endoscopic'}, {'cui': 'C0450117', 'cui_str': 'Laryngotracheal (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts (observable entity)'}]",15.0,0.365755,There was no difference in magnitude of peak inspiratory flow (PIF) improvement between groups.,"[{'ForeName': 'Katherine C', 'Initials': 'KC', 'LastName': 'Yung', 'Affiliation': 'San Francisco Voice and Swallowing, San Francisco, California, U.S.A.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, University of California, San Francisco, San Francisco, California, U.S.A.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Courey', 'Affiliation': 'Eugen Grabscheid Voice Center, Department of Otolaryngology-Head and Neck Surgery, Mount Sinai Health System, New York, New York, U.S.A.'}]",The Laryngoscope,['10.1002/lary.28025']
3097,32067259,Baseline and interim PET-based outcome prediction in peripheral T-cell lymphoma: A subgroup analysis of the PETAL trial.,"The prospective randomized Positron Emission Tomography (PET)-Guided Therapy of Aggressive Non-Hodgkin Lymphomas (PETAL) trial was designed to test the ability of interim PET (iPET) to direct therapy. As reported previously, outcome remained unaffected by iPET-based treatment changes. In this subgroup analysis, we studied the prognostic value of baseline total metabolic tumor volume (TMTV) and iPET response in 76 patients with T-cell lymphoma. TMTV was measured using the 41% maximum standardized uptake value (SUV 41max  ) and SUV 4  thresholding methods. Interim PET was performed after two treatment cycles and evaluated using the ΔSUV max  approach and the Deauville scale. Because of significant differences in outcome, patients with anaplastic lymphoma kinase (ALK)-positive lymphoma were analyzed separately from patients with ALK-negative lymphoma. In the latter, TMTV was statistically significantly correlated with progression-free survival, with thresholds best dichotomizing the population, of 232 cm 3  using SUV 41max  and 460 cm 3  using SUV 4  . For iPET response, the respective thresholds were 46.9% SUV max  reduction and Deauville score 1-4 vs 5. The proportion of poor prognosis patients was 46% and 29% for TMTV by SUV 41max  and SUV 4  , and 29% and 25% for iPET response by ΔSUV max  and Deauville, respectively. At diagnosis, the hazard ratio (95% confidence interval) for poor prognosis vs good prognosis patients according to TMTV was 2.291 (1.135-4.624) for SUV 41max  and 3.206 (1.524-6.743) for SUV 4  . At iPET, it was 3.910 (1.891-8.087) for ΔSUV max  and 4.371 (2.079-9.187) for Deauville. On multivariable analysis, only TMTV and iPET response independently predicted survival. Patients with high baseline TMTV and poor iPET response (22% of the population) invariably progressed or died within the first year (hazard ratio, 9.031 [3.651-22.336]). Due to small numbers and events, PET did not predict survival in ALK-positive lymphoma. Baseline TMTV and iPET response are promising tools to select patients with ALK-negative T-cell lymphoma for early allogeneic transplantation or innovative therapies.",2020,"For iPET response, the respective thresholds were 46.9% SUV max  reduction and Deauville score 1-4 vs 5.","['76 patients with T-cell lymphoma', 'peripheral T-cell lymphoma', 'patients with ALK-negative T-cell lymphoma for early allogeneic transplantation or innovative therapies', 'patients with anaplastic lymphoma kinase (ALK)-positive lymphoma were analyzed separately from patients with ALK-negative lymphoma']",['Positron Emission Tomography (PET)-Guided Therapy'],"['prognostic value of baseline total metabolic tumor volume (TMTV) and iPET response', 'iPET response', 'progression-free survival', 'TMTV', 'hazard ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079772', 'cui_str': 'T-Cell Lymphoma'}, {'cui': 'C0079774', 'cui_str': 'Peripheral T-Cell Lymphoma'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic Grafting'}, {'cui': 'C1136080', 'cui_str': 'Innovative Therapies'}, {'cui': 'C0252409', 'cui_str': 'NPM-ALK'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}]","[{'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",76.0,0.0585731,"For iPET response, the respective thresholds were 46.9% SUV max  reduction and Deauville score 1-4 vs 5.","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Schmitz', 'Affiliation': 'Klinik für Hämatologie, Universitätsklinikum Essen, Essen, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Rekowski', 'Affiliation': 'Institut für Medizinische Informatik, Biometrie und Epidemiologie, Universität Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Stefan P', 'Initials': 'SP', 'LastName': 'Müller', 'Affiliation': 'Klinik für Nuklearmedizin, Universitätsklinikum Essen, Essen, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Hertenstein', 'Affiliation': 'Medizinische Klinik I, Klinikum Bremen-Mitte, Bremen, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Franzius', 'Affiliation': 'Zentrum für moderne Diagnostik (Zemodi), Zentrum für Nuklearmedizin und PET/CT, Bremen, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Klinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover, Hannover, Germany.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Bengel', 'Affiliation': 'Klinik für Nuklearmedizin, Medizinische Hochschule Hannover, Hannover, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Kroschinsky', 'Affiliation': 'Medizinische Klinik I, Universitätsklinikum Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Kotzerke', 'Affiliation': 'Klinik für Nuklearmedizin, Universitätsklinikum Carl Gustav Carus, Dresden, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'La Rosée', 'Affiliation': 'Klinik für Innere Medizin II, Universitätsklinikum Jena, Jena, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Freesmeyer', 'Affiliation': 'Klinik für Nuklearmedizin, Universitätsklinikum Jena, Jena, Germany.'}, {'ForeName': 'Heinz-Gert', 'Initials': 'HG', 'LastName': 'Hoeffkes', 'Affiliation': 'Tumorklinik, Klinikum Fulda, Fulda, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hertel', 'Affiliation': 'Klinik für Diagnostische und Therapeutische Nuklearmedizin, Klinikum Fulda, Fulda, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Behringer', 'Affiliation': 'Klinik für Hämatologie, Onkologie und Palliativmedizin, Augusta-Kranken-Anstalt, Bochum, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Mesters', 'Affiliation': 'Medizinische Klinik A, Universitätsklinikum Münster, Münster, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Weckesser', 'Affiliation': 'Klinik für Nuklearmedizin, Universitätsklinikum Münster, Münster, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Mahlmann', 'Affiliation': 'Klinik für Innere Medizin 1, Westpfalz-Klinikum, Kaiserslautern, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Haberkorn', 'Affiliation': 'Radiologische Klinik und Poliklinik, Universitätsklinikum Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Martens', 'Affiliation': 'Klinik für Innere Medizin III: Hämatologie, Onkologie, Palliativmedizin, Klinikum am Gesundbrunnen, Heilbronn, Germany.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Prange-Krex', 'Affiliation': 'Onkologische Gemeinschaftspraxis, Dresden, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Brenner', 'Affiliation': 'Klinik für Nuklearmedizin, Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Aristoteles', 'Initials': 'A', 'LastName': 'Giagounidis', 'Affiliation': 'Klinik für Onkologie, Hämatologie und Palliativmedizin, Marien Hospital, Düsseldorf, Germany.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Moeller', 'Affiliation': 'Hämatologisch-onkologische Gemeinschaftspraxis, Halle, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Runde', 'Affiliation': 'Klinik für Innere Medizin mit den Schwerpunkten Hämatologie, Onkologie und Palliativmedizin, Wilhelm-Anton-Hospital, Goch, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Sandmann', 'Affiliation': 'Klinik für Innere Medizin III - Hämatologie und Onkologie, Palliativmedizin, Petrus-Krankenhaus, Wuppertal, Germany.'}, {'ForeName': 'Hubertus', 'Initials': 'H', 'LastName': 'Hautzel', 'Affiliation': 'Klinik für Nuklearmedizin, Universitätsklinikum Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wilop', 'Affiliation': 'Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation, Universitätsklinikum Aachen, Aachen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Krohn', 'Affiliation': 'Klinik für Nuklearmedizin, Universitätsklinikum Aachen, Aachen, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Dürk', 'Affiliation': 'Klinik für Hämatologie, Onkologie und Palliativmedizin, Evangelisches Krankenhaus, Hamm, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heike', 'Affiliation': 'Klinik für Gastroenterologie, Hämatologie und internistische Onkologie und Endokrinologie, Klinikum Dortmund, Germany.'}, {'ForeName': 'Ferras', 'Initials': 'F', 'LastName': 'Alashkar', 'Affiliation': 'Klinik für Hämatologie, Universitätsklinikum Essen, Essen, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Brinkmann', 'Affiliation': 'Zentrum für Klinische Studien Essen (ZKSE), Universität Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Trenn', 'Affiliation': 'Klinik für Innere Medizin I, Knappschaftskrankenhaus, Bottrop, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Wacker', 'Affiliation': 'Medizinische Klinik III, Hämatologie, Onkologie und Palliativmedizin, Klinikum Vest, Recklinghausen, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Kreisel-Büstgens', 'Affiliation': 'Zentrum für Hämatologie und Onkologie, Porta Westfalica, Germany.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Bernhard', 'Affiliation': 'Medizinische Klinik V, Klinikum Darmstadt, Darmstadt, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Heil', 'Affiliation': 'Klinik für Hämatologie und Onkologie, Klinikum Lüdenscheid, Lüdenscheid, Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Larisch', 'Affiliation': 'Klinik für Nuklearmedizin, Klinikum Lüdenscheid, Lüdenscheid, Germany.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Kurch', 'Affiliation': 'Klinik und Poliklinik für Nuklearmedizin, Universitätsklinikum Leipzig, Leipzig, Germany.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Jöckel', 'Affiliation': 'Institut für Medizinische Informatik, Biometrie und Epidemiologie, Universität Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Hoelzer', 'Affiliation': 'Onkologikum, Frankfurt/Main, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Klapper', 'Affiliation': 'Institut für Pathologie, Sektion für Hämatopathologie, Universitätsklinikum Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Boellaard', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, Location VUMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Dührsen', 'Affiliation': 'Klinik für Hämatologie, Universitätsklinikum Essen, Essen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hüttmann', 'Affiliation': 'Klinik für Hämatologie, Universitätsklinikum Essen, Essen, Germany.'}]",Hematological oncology,['10.1002/hon.2697']
3098,31356508,Physical Activity Is Higher in Patients with LVADs Compared to Chronic Heart Failure.,"PURPOSE


Left ventricular assist devices (LVADs) are associated with an increased aerobic capacity in patients with chronic heart failure (CHF). However, studies evaluating the impact of LVAD implantation on physical activity (PA) are lacking. The aim of this study was to compare daily PA levels in participants with LVADs with well-matched CHF participants.
METHODS


Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation. Participants underwent a cardiopulmonary exercise test to determine peak oxygen consumption (V[Combining Dot Above]O2 peak). PA was monitored continuously for seven consecutive days with an Actiheart monitor.
RESULTS


V[Combining Dot Above]O2 peak in the CHF group (12.3 ± 3.5 ml·kg·min) was not significantly different to the LVAD group prior to LVAD implantation (10.4 ± 2.1 ml·kg·min), but was lower than in the LVAD group following implantation (15.8 ± 4.3 ml·kg·min; p < 0.05). PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001). LVAD participants spent more time performing moderate intensity PA than their CHF counterparts, 26 (24-40) [median (IQR)] vs. 12 (9-16) min/day; p < 0.001. PA was correlated with V[Combining Dot Above]O2 peak (r = 0.582; p = 0.001) across participants in the CHF and LVAD groups.
CONCLUSION


Higher levels of PA were observed in participants with LVAD compared with patients with advanced CHF. This may be due to a higher V[Combining Dot Above]O2 peak, resulting in an improved capacity to perform activities of daily living with less symptoms.",2019,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"['Sixteen participants with an LVAD (age: 59.1 ± 10.8 years) were case-matched to 16 participants with advanced CHF (age: 58.3 ± 8.7 years), who were listed or being considered for cardiac transplantation', 'patients with chronic heart failure (CHF', 'participants with LVADs with well-matched CHF participants']","['LVAD implantation', 'Left ventricular assist devices (LVADs', 'cardiopulmonary exercise test', 'LVAD']","['Dot Above]O2 peak', 'time performing moderate intensity PA', 'V[Combining Dot Above]O2 peak', 'PA', 'peak oxygen consumption (V[Combining Dot Above]O2 peak', 'Physical Activity', 'aerobic capacity', 'daily PA levels', 'Higher levels of PA']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4517880', 'cui_str': '8.7 (qualifier value)'}, {'cui': 'C0018823', 'cui_str': 'Transplantation, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}]","[{'cui': 'C1720485', 'cui_str': 'Corneal epithelial microcysts'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",16.0,0.0464878,PA was higher in the LVAD (19.7 ± 6.4 kJ·kg·day) compared with the CHF group (11.6 ± 6.9 kJ·kg·day; p = 0.001).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Moreno-Suarez', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Liew', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Lawrence G', 'Initials': 'LG', 'LastName': 'Dembo', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Larbalestier', 'Affiliation': 'Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002104']
3099,31411383,Relative Bioavailability of Enalapril Administered as Orodispersible Minitablets in Healthy Adults.,"The angiotensin-converting enzyme inhibitor enalapril is commonly used to treat chronic heart failure in children. Because some children are unable to swallow capsules or tablets, a new, age-appropriate, orodispersible minitablet (ODMT) containing 1 mg of enalapril was developed within the EU-funded LENA (Labeling of Enalapril from Neonates up to Adolescents) consortium. In order to support the clinical evaluation of this new formulation in children, a relative bioavailability study was performed in healthy adults, comparing the bioavailability of enalapril in the ODMT with that of a reference product (RP) Renitec, a registered standard enalapril tablet formulation. In this open-label, randomized 3-way crossover study, 24 healthy subjects received a 10-mg enalapril dose administered as (1) 2 × 5-mg tablets of the RP swallowed with water, (2) 10 × 1-mg ODMT swallowed with water, and (3) 10 × 1 mg ODMT dispersed on the tongue. When the relative bioavailability of the ODMT formulation swallowed with water was compared with that of the RP, the estimated 90%CIs for the ratio of area under the concentration-time curve (AUC 0-∞  ) and or peak concentration (C max  ) of enalapril were 92.34% to 106.49% and 91.28% to 115.72%, respectively, which are within the accepted bioequivalence limits of 80% to 125%. Following dispersion of the ODMT in the mouth, a slightly higher C max  for enalapril was observed as compared with the RP with an upper 90%CI of 127.57%, slightly exceeding the bioequivalence limit. Taken together, it was demonstrated that the method of administration of the ODMT, swallowed or dispersed, did not significantly affect the bioavailability of enalapril.",2020,"When the relative bioavailability of the ODMT formulation swallowed with water was compared with that of the RP, the estimated 90%CIs for the ratio of area under the concentration-time curve (AUC 0-∞  ) and or peak concentration (C max  ) of enalapril were 92.34% to 106.49% and 91.28% to 115.72%, respectively, which are within the accepted bioequivalence limits of 80% to 125%.","['Healthy Adults', 'healthy adults', '24 healthy subjects', 'children']","['Enalapril', '10-mg enalapril dose administered as (1) 2\xa0×\xa05-mg tablets of the RP swallowed with water, (2) 10', 'angiotensin-converting enzyme inhibitor enalapril', 'enalapril']","['Relative Bioavailability', 'bioavailability of enalapril', 'ratio of area under the concentration-time curve (AUC 0-∞  ) and or peak concentration (C max  ) of enalapril']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0104281', 'cui_str': 'AS 2'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}]","[{'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",24.0,0.0256863,"When the relative bioavailability of the ODMT formulation swallowed with water was compared with that of the RP, the estimated 90%CIs for the ratio of area under the concentration-time curve (AUC 0-∞  ) and or peak concentration (C max  ) of enalapril were 92.34% to 106.49% and 91.28% to 115.72%, respectively, which are within the accepted bioequivalence limits of 80% to 125%.","[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Van Hecken', 'Affiliation': 'Center for Clinical Pharmacology, University Hospitals of Leuven, Leuven, Belgium.'}, {'ForeName': 'Björn B', 'Initials': 'BB', 'LastName': 'Burckhardt', 'Affiliation': 'Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Feras', 'Initials': 'F', 'LastName': 'Khalil', 'Affiliation': 'Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'de Hoon', 'Affiliation': 'Center for Clinical Pharmacology, University Hospitals of Leuven, Leuven, Belgium.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Klingmann', 'Affiliation': 'Pharmaplex bvba, Wezembeek-Oppem, Belgium.'}, {'ForeName': 'Marissa', 'Initials': 'M', 'LastName': 'Herbots', 'Affiliation': 'Center for Clinical Pharmacology, University Hospitals of Leuven, Leuven, Belgium.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Laeer', 'Affiliation': 'Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Florian B', 'Initials': 'FB', 'LastName': 'Lagler', 'Affiliation': 'Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Breitkreutz', 'Affiliation': 'Ethicare GmbH, Haltern am See, Germany.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.728']
3100,31356985,Large Treatment Effect With Extended Home-Based Transcranial Direct Current Stimulation Over Dorsolateral Prefrontal Cortex in Fibromyalgia: A Proof of Concept Sham-Randomized Clinical Study.,"This randomized, double-blind controlled trial tested the hypothesis that 60 sessions of home-based anodal (a)-transcranial direct current stimulation (tDCS) over dorsolateral prefrontal cortex (DLPFC) would be better than home-based sham-tDCS to improve the widespread pain and the disability-related to pain. The anodal-tDCS (2 mA for 30 minutes) over the left DLPFC was self-administered with a specially developed device following in-person training. Twenty women, 18 to 65 years old were randomized into 2 groups [active-(a)-tDCS (n = 10) or sham-(s)-tDCS (n = 10)]. Post hoc analysis revealed that after the first 20 sessions of a-tDCS, the cumulative pain scores reduced by 45.65% [7.25 (1.43) vs 3.94 (1.14), active vs sham tDCS, respectively]. After 60 sessions, during the 12-week assessment, pain scores reduced by 62.06% in the actively group [visual analogue scale reduction, 7.25 (1.43) to 2.75 (.85)] compared to 24.92% in the s-tDCS group, [mean (SD) 7.10 (1.81) vs 5.33 (.90)], respectively. It reduced the risk for analgesic use in 55%. Higher serum levels of the brain-derived neurotrophic factor predicted higher decreases on the pain scores across of treatment. PERSPECTIVE: These findings bring 3 important insights: 1) show that an extended period of treatment (60 sessions, to date the largest number of tDCS sessions tested) for fibromyalgia induces large pain decreases (a large effect size of 1.59) and 2) support the feasibility of home-based tDCS as a method of intervention; 3) provide additional data on DLPFC target for the treatment of fibromyalgia. Finally, our findings also highlight that brain-derived neurotrophic factor to index neuroplasticity may be a valuable predictor of the tDCS effect on pain scores decreases across the treatment.",2020,"After 60 sessions, during the 12-week assessment, pain scores reduced by 62.06% in the actively group [visual analogue scale reduction, 7.25 (1.43) to 2.75 (.85)] compared to 24.92% in the s-tDCS group, [mean (SD) 7.10 (1.81) vs 5.33 (.90)], respectively.","['Fibromyalgia', 'Twenty women, 18 to 65 years old']","['anodal-tDCS', 'home-based anodal (a)-transcranial direct current stimulation (tDCS) over dorsolateral prefrontal cortex (DLPFC', 'Extended Home-Based Transcranial Direct Current Stimulation', 'sham-(s)-tDCS', 'active-(a)-tDCS']","['visual analogue scale reduction', 'cumulative pain scores', 'pain scores']","[{'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",20.0,0.213709,"After 60 sessions, during the 12-week assessment, pain scores reduced by 62.06% in the actively group [visual analogue scale reduction, 7.25 (1.43) to 2.75 (.85)] compared to 24.92% in the s-tDCS group, [mean (SD) 7.10 (1.81) vs 5.33 (.90)], respectively.","[{'ForeName': 'Aline P', 'Initials': 'AP', 'LastName': 'Brietzke', 'Affiliation': 'Post-Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Laboratory of Pain and Neuromodulation at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Maxciel', 'Initials': 'M', 'LastName': 'Zortea', 'Affiliation': 'Post-Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Laboratory of Pain and Neuromodulation at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Carvalho', 'Affiliation': 'Post-Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Laboratory of Pain and Neuromodulation at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Paulo R S', 'Initials': 'PRS', 'LastName': 'Sanches', 'Affiliation': 'Laboratory of Biomedical Engineering at HCPA, Porto Alegre, Brazil.'}, {'ForeName': 'Danton P Jr', 'Initials': 'DPJ', 'LastName': 'Silva', 'Affiliation': 'Laboratory of Biomedical Engineering at HCPA, Porto Alegre, Brazil.'}, {'ForeName': 'Iraci Lucena da Silva', 'Initials': 'ILDS', 'LastName': 'Torres', 'Affiliation': 'Post-Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Laboratory of Pain and Neuromodulation at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil; Laboratory of Biomedical Engineering at HCPA, Porto Alegre, Brazil; Laboratory of Neuromodulation and Center for Clinical Research Learning, Physics and Rehabilitation Department, Spaulding Rehabilitation Hospital, Boston, Massachusetts; Pain and Palliative Care Service at HCPA, Porto Alegre, Brazil; Department of Surgery, School of Medicine, UFRGS, Porto Alegre, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Laboratory of Neuromodulation and Center for Clinical Research Learning, Physics and Rehabilitation Department, Spaulding Rehabilitation Hospital, Boston, Massachusetts.'}, {'ForeName': 'Wolnei', 'Initials': 'W', 'LastName': 'Caumo', 'Affiliation': 'Post-Graduate Program in Medical Sciences, School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil; Laboratory of Pain and Neuromodulation at Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil; Laboratory of Neuromodulation and Center for Clinical Research Learning, Physics and Rehabilitation Department, Spaulding Rehabilitation Hospital, Boston, Massachusetts; Pain and Palliative Care Service at HCPA, Porto Alegre, Brazil; Department of Surgery, School of Medicine, UFRGS, Porto Alegre, Brazil. Electronic address: wcaumo@hcpa.edu.br.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.06.013']
3101,31983585,Impact of vaccination on the risk factors for acute rotavirus diarrhea: An analysis of the data of a cluster randomized trial conducted in a rural area of Bangladesh.,"BACKGROUND


Rotavirus is one of the causes of severe diarrhea and death in young children. To control the disease, safe and effective vaccines are being used in several countries. We assessed the impact of vaccination on the risk factors for acute rotavirus diarrhea (ARD) in Bangladesh.
METHODS


We used the data of a cluster-randomized trial. The clusters were 142 villages, 71 in each of the two arms of study. The infants were offered human rotavirus vaccine (HRV), Rotarix, over three-year period. We divided the time period into two equal periods (T1 and T2). A generalized estimating equation with logit-link function was used to evaluate the risk factors by arm and by period.
RESULTS


Among 10,917 children, 5,759 (53%) were in the HRV villages. We had 359 cases; 44% in the HRV villages. Mean age of attack was similar between the arms of study in T1, but significantly higher in HRV villages than that in the non-HRV villages in T2. In HRV villages, males were at a higher risk of having ARD than females in T1, but not in T2. In contrast, males were at a higher risk of having ARD in both the time periods in non-HRV villages. In HRV-villages, children having literate mother were at significantly higher risk of having ARD in T1 but not in T2; whereas children in the non-HRV villages had a higher risk of having ARD in T2. Children living in an area with higher phone users had more cases than their counterpart in non-HRV villages, but not in HRV villages.
CONCLUSION


Our study illustrates that several risk factors for ARD varied between the two arms of study as well as between the two periods of study. Assessing post-vaccination risk factors is, therefore, important for understanding the impact of vaccination and undertaking post-vaccination control measures.",2020,"Children living in an area with higher phone users had more cases than their counterpart in non-HRV villages, but not in HRV villages.
","['acute rotavirus diarrhea', 'young children', 'acute rotavirus diarrhea (ARD) in Bangladesh', '10,917 children, 5,759 (53%) were in the HRV villages', 'rural area of Bangladesh']","['vaccination', 'human rotavirus vaccine (HRV), Rotarix']","['Mean age of attack', 'risk of having ARD']","[{'cui': 'C0035870', 'cui_str': 'Rotavirus'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0318711', 'cui_str': 'Human rotavirus (organism)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1528012', 'cui_str': 'Rotarix'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}]",10917.0,0.0424127,"Children living in an area with higher phone users had more cases than their counterpart in non-HRV villages, but not in HRV villages.
","[{'ForeName': 'Asma Binte', 'Initials': 'AB', 'LastName': 'Aziz', 'Affiliation': 'icddr,b, Dhaka, Bangladesh. Electronic address: asma.aziz@icddrb.org.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ali', 'Affiliation': 'Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Ahsan-Ul Habib', 'Initials': 'AH', 'LastName': 'Basunia', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Md', 'Initials': 'M', 'LastName': 'Yunus', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Clemens', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'icddr,b, Dhaka, Bangladesh.'}]",Vaccine,['10.1016/j.vaccine.2020.01.041']
3102,31983583,The effect of performance-based financing on child vaccinations in northern Nigeria.,"Vaccination is known to be one of the most cost-effective ways to avert child deaths. However, in Nigeria, the vaccination completion rate among children is extremely low and the child mortality rate is one of the highest in the world. National immunization coverage survey shows that the low vaccination rate in Nigeria is partly attributed to service delivery issues. This paper evaluates the effect of Performance-Based Financing (PBF), an incentive scheme where health facilities are funded based on their performance, on the quantity of vaccinations carried out in Adamawa state. Under the Nigeria State Health Investment Project (NSHIP), half of the Local Government Areas (LGAs) in Adamawa State were randomly assigned to receive PBF intervention between 2015 and 2018. The Difference-in-Differences (DiD) technique as well as ANCOVA analysis are used to evaluate the effect of PBF on vaccination service delivery indicators. We find that the PBF intervention significantly increased the quantity of full vaccination cases as compared to the comparison group, although the effect size was small. On the other hand, if health facilities receive intensified PEI (Polio Eradication Initiative) concurrently, the effectiveness of PBF in increasing the number of full vaccination cases do not differ significantly from health facilities that are not under PBF. Rather than providing conditional financial incentives such as PBF to health facilities, simply providing unconditional financial and technical assistance to strengthen routine immunization programs might be sufficient to increase the quantity of vaccination service provision. The positive effect of PBF on vaccination provision was not sustainable, either. Future work should explore how we can strengthen the health system in a cost-effective and sustainable way.",2020,"We find that the PBF intervention significantly increased the quantity of full vaccination cases as compared to the comparison group, although the effect size was small.","['child vaccinations in northern Nigeria', 'Under the Nigeria State Health Investment Project (NSHIP), half of the Local Government Areas (LGAs) in Adamawa State']","['PBF intervention', 'Performance-Based Financing (PBF', 'performance-based financing', 'PBF']","['quantity of full vaccination cases', 'child mortality rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021953', 'cui_str': 'Investments'}, {'cui': 'C0026788', 'cui_str': 'Local Government'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243097', 'cui_str': 'financing'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0008083', 'cui_str': 'Child Mortality'}]",,0.0217779,"We find that the PBF intervention significantly increased the quantity of full vaccination cases as compared to the comparison group, although the effect size was small.","[{'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Sato', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, USA. Electronic address: rsato@hsph.harvard.edu.'}, {'ForeName': 'Abdullahi', 'Initials': 'A', 'LastName': 'Belel', 'Affiliation': 'Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, USA.'}]",Vaccine,['10.1016/j.vaccine.2020.01.033']
3103,31804890,"Acetazolamide does not alter endurance exercise performance at 3,500-m altitude.","Acetazolamide (AZ) is a medication commonly used to prevent acute mountain sickness (AMS) during rapid ascent to high altitude. However, it is unclear whether AZ use impairs exercise performance; previous literature regarding this topic is equivocal. The purpose of this study was to evaluate the impact of AZ on time-trial (TT) performance during a 30-h exposure to hypobaric hypoxia equivalent to 3,500-m altitude. Ten men [sea-level peak oxygen consumption (VO 2 peak): 50.8 ± 6.5 mL·kg -1 ·min -1 ; body fat %: 20.6 ± 5.2%] completed 2 30-h exposures at 3,500 m. In a crossover study design, subjects were given 500 mg/day of either AZ or a placebo. Exercise testing was completed 2 h and 24 h after ascent and consisted of 15-min steady-state treadmill walking at 40%-45% sea-level VO 2 peak, followed by a 2-mile self-paced treadmill TT. AMS was assessed after ~12 h and 22 h at 3,500 m. The incidence of AMS decreased from 40% with placebo to 0% with AZ. Oxygen saturation was higher ( P  < 0.05) in AZ versus placebo trials at the end of the TT after 2 h (85 ± 3% vs. 79 ± 3%) and 24 h (86 ± 3% vs. 81 ± 4%). There was no difference in time to complete 2 miles between AZ and PL after 2 h (20.7 ± 3.2 vs. 22.7 ± 5.0 min,  P  > 0.05) or 24 h (21.5 ± 3.4 vs. 21.1 ± 2.9 min,  P  > 0.05) of exposure to altitude. Our results suggest that AZ (500 mg/day) does not negatively impact endurance exercise performance at 3,500 m. NEW & NOTEWORTHY  To our knowledge, this is the first study to examine the impact of acetazolamide (500 mg/day) versus placebo on self-paced, peak-effort exercise performance using a short-duration exercise test in a hypobaric hypoxic environment with a repeated-measures design. In the present study, acetazolamide did not impact exercise performance after 2-h or 24-h exposure to 3,500-m simulated altitude.",2020,Oxygen saturation was higher ( P  < 0.05) in AZ versus placebo trials at the end of the TT after 2 h (85 ± 3% vs. 79 ± 3%) and 24 h (86 ± 3% vs. 81 ± 4%).,"['Ten men [sea-level peak oxygen consumption (VO 2 peak): 50.8\u2009±\u20096.5 mL·kg -1 ·min -1 ; body fat %: 20.6\u2009±\u20095.2%] completed 2 30-h exposures at 3,500 m']","['AZ', 'Acetazolamide (AZ', 'placebo', 'acetazolamide', 'Acetazolamide']","['impact exercise performance', 'time-trial (TT) performance', 'incidence of AMS', 'impact endurance exercise performance', 'Oxygen saturation', 'AMS', 'time to complete 2 miles', 'endurance exercise performance']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C1301862', 'cui_str': 'Min 1'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0419120', 'cui_str': 'Muscular endurance development exercise (regime/therapy)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0331865', 'cui_str': 'Mile (qualifier value)'}]",,0.104981,Oxygen saturation was higher ( P  < 0.05) in AZ versus placebo trials at the end of the TT after 2 h (85 ± 3% vs. 79 ± 3%) and 24 h (86 ± 3% vs. 81 ± 4%).,"[{'ForeName': 'Karleigh E', 'Initials': 'KE', 'LastName': 'Bradbury', 'Affiliation': 'Thermal and Mountain Medicine Division, US Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Beau R', 'Initials': 'BR', 'LastName': 'Yurkevicius', 'Affiliation': 'Thermal and Mountain Medicine Division, US Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Mitchell', 'Affiliation': 'Thermal and Mountain Medicine Division, US Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Kirsten E', 'Initials': 'KE', 'LastName': 'Coffman', 'Affiliation': 'Thermal and Mountain Medicine Division, US Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Roy M', 'Initials': 'RM', 'LastName': 'Salgado', 'Affiliation': 'Thermal and Mountain Medicine Division, US Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fulco', 'Affiliation': 'Thermal and Mountain Medicine Division, US Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Kenefick', 'Affiliation': 'Thermal and Mountain Medicine Division, US Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Charkoudian', 'Affiliation': 'Thermal and Mountain Medicine Division, US Army Research Institute of Environmental Medicine, Natick, Massachusetts.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00655.2019']
3104,31831062,Pulmonary Metastasectomy versus Continued Active Monitoring in Colorectal Cancer (PulMiCC): a multicentre randomised clinical trial.,"BACKGROUND


Lung metastasectomy in the treatment of advanced colorectal cancer has been widely adopted without good evidence of survival or palliative benefit. We aimed to test its effectiveness in a randomised controlled trial (RCT).
METHODS


Multidisciplinary teams in 13 hospitals recruited participants with potentially resectable lung metastases to a multicentre, two-arm RCT comparing active monitoring with or without metastasectomy. Other local or systemic treatments were decided by the local team. Randomisation was remote and stratified by site with minimisation for age, sex, primary cancer stage, interval since primary resection, prior liver involvement, the number of metastases, and carcinoembryonic antigen level. The central Trial Management Group were blind to patient allocation until completion of the analysis. Analysis was on intention to treat with a margin for non-inferiority of 10%.
RESULTS


Between December 2010 and December 2016, 65 participants were randomised. Characteristics were well-matched in the two arms and similar to those in reported studies: age 35 to 86 years (interquartile range (IQR) 60 to 74); primary resection IQR 16 to 35 months previously; stage at resection T1, 2 or 3 in 3, 8 and 46; N1 or N2 in 31 and 26; unknown in 8. Lung metastases 1 to 5 (median 2); 16/65 had previous liver metastases; carcinoembryonic antigen normal in 55/65. There were no other interventions in the first 6 months, no crossovers from control to treatment, and no treatment-related deaths or major adverse events. The Hazard ratio for death within 5 years, comparing metastasectomy with control, was 0.82 (95%CI 0.43, 1.56).
CONCLUSIONS


Because of poor and worsening recruitment, the study was stopped. The small number of participants in the trial (N = 65) precludes a conclusive answer to the research question given the large overlap in the confidence intervals in the proportions still alive at all time points. A widely held belief is that the 5-year absolute survival benefit with metastasectomy is about 35%: 40% after metastasectomy compared to < 5% in controls. The estimated survival in this study was 38% (23-62%) for metastasectomy patients and 29% (16-52%) in the well-matched controls. That is the new and important finding of this RCT.
TRIAL REGISTRATION


ClinicalTrials.gov, ID: NCT01106261. Registered on 19 April 2010.",2019,"The Hazard ratio for death within 5 years, comparing metastasectomy with control, was 0.82 (95%CI 0.43, 1.56).
","['advanced colorectal cancer', 'Colorectal Cancer (PulMiCC', '65 participants were randomised', 'Between December 2010 and December 2016', '13 hospitals recruited participants with potentially resectable lung metastases to a multicentre, two-arm RCT comparing active monitoring with or without metastasectomy', 'studies: age 35 to 86\u2009years (interquartile range (IQR) 60 to 74); primary resection IQR 16 to 35\u2009months previously; stage at resection T1, 2 or 3 in 3, 8 and 46; N1 or N2 in 31 and 26; unknown in 8', 'Lung metastases 1 to 5 (median 2); 16/65 had previous liver metastases; carcinoembryonic antigen normal in 55/65']",['Pulmonary Metastasectomy versus Continued Active Monitoring'],"['estimated survival', 'deaths or major adverse events', 'Hazard ratio for death']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1531698', 'cui_str': 'Active monitoring'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0855349', 'cui_str': 'Carcinoembryonic antigen normal'}]","[{'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C2363923', 'cui_str': 'Metastasectomy'}, {'cui': 'C1531698', 'cui_str': 'Active monitoring'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",65.0,0.320627,"The Hazard ratio for death within 5 years, comparing metastasectomy with control, was 0.82 (95%CI 0.43, 1.56).
","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Treasure', 'Affiliation': 'Clinical Operational Research Unit, University College London, London, WC1H 0BT, UK. tom.treasure@gmail.com.'}, {'ForeName': 'Vern', 'Initials': 'V', 'LastName': 'Farewell', 'Affiliation': 'MRC Biostatistics Unit, Cambridge, CB2 0SR, UK.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Macbeth', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, CF14 4Y, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Monson', 'Affiliation': 'Sussex Health Outcomes Research and Education in Cancer (SHORE-C), Falmer, BN1 9RX, UK.'}, {'ForeName': 'Norman R', 'Initials': 'NR', 'LastName': 'Williams', 'Affiliation': 'Surgical and Interventional Trials Unit (SITU), University College London, London, W1W 7JN, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brew-Graves', 'Affiliation': 'Surgical and Interventional Trials Unit (SITU), University College London, London, W1W 7JN, UK.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Lees', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, OX3 9DU, UK.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Grigg', 'Affiliation': 'MRC Biostatistics Unit, Cambridge, CB2 0SR, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Fallowfield', 'Affiliation': 'Sussex Health Outcomes Research and Education in Cancer (SHORE-C), Falmer, BN1 9RX, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3837-y']
3105,29807715,[Moderate exercise and intake of either high or low glycemic index carbohydrates in sedentary women].,"OBJECTIVE


To analyze changes in blood glucose, insulin and triglyceride concentrations in relation to a moderate aerobic exercise in sedentary women of different body weight, exposed to either a high or low glycemic index carbohydrates diet. DISEñO: Cross-over type. SITE: Research was performed in the Exercise Physiology Laboratory at Facultad de Ciencias de la Cultura Física, Universidad Autónoma de Chihuahua, México.
PARTICIPANTS


Twenty-six young sedentary women who did not exercise in the last year participated in the study. Four of adequate weight (AW) and 2 with obesity (OB) were excluded for not consuming the suggested carbohydrates (1gr/kg of weight) nor completed the programed exercise. There were n=10 in each group (AW/OB).
INTERVENTION


Two treatments of 55minutes of aerobic exercise each were applied one day after consuming either high or low glycemic index carbohydrates.
MAIN MEASUREMENTS


Plasmatic glucose, insulin, and triglycerides were determined before and after the scheduled exercise.
RESULTS


Glucose, insulin, and triglycerides were higher in OB than in AW at baseline. Glucose was normalized in OB from 5.8±0.35 to 5.3±0.23 mmol/L (P=.001), only by eating foods with low glycemic index; triglycerides increased from 139.5±66.0 to 150.8±67.2mg/dl (P=.004) at the end of the exercise, after consumption of low glycemic index carbohydrates.
CONCLUSION


Elevation of triglycerides secondary to exercise after consumption of low glycemic index seems to indicate an increase of lipid oxidation in OB.",2019,"RESULTS


Glucose, insulin, and triglycerides were higher in OB than in AW at baseline.","['sedentary women', 'Twenty-six young sedentary women who did not exercise in the last year participated in the study', 'sedentary women of different body weight, exposed to either a high or low glycemic index carbohydrates diet']","['aerobic exercise', 'Moderate exercise and intake of either high or low glycemic index carbohydrates', 'SITE']","['Glucose', 'Glucose, insulin, and triglycerides', 'OB', 'lipid oxidation', 'eating foods with low glycemic index; triglycerides', 'blood glucose, insulin and triglyceride concentrations', 'Plasmatic glucose, insulin, and triglycerides']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0301577', 'cui_str': 'Carbohydrate diet (finding)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",26.0,0.0217883,"RESULTS


Glucose, insulin, and triglycerides were higher in OB than in AW at baseline.","[{'ForeName': 'Briseidy', 'Initials': 'B', 'LastName': 'Ortiz-Rodríguez', 'Affiliation': 'Facultad de Ciencias de la Cultura Física, Universidad Autónoma de Chihuahua, Chihuahua, México.'}, {'ForeName': 'Lidia G', 'Initials': 'LG', 'LastName': 'De León', 'Affiliation': 'Facultad de Ciencias de la Cultura Física, Universidad Autónoma de Chihuahua, Chihuahua, México. Electronic address: gdeleon@uach.mx.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Esparza-Romero', 'Affiliation': 'Departamento de Nutrición y Metabolismo, Coordinación de Nutrición, Centro de Investigación en Alimentación y Desarrollo, A. C. (CIAD, A.C.), Hermosillo, Sonora, México.'}, {'ForeName': 'Claudia E', 'Initials': 'CE', 'LastName': 'Carrasco-Legleu', 'Affiliation': 'Facultad de Ciencias de la Cultura Física, Universidad Autónoma de Chihuahua, Chihuahua, México.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Candia-Luján', 'Affiliation': 'Facultad de Ciencias de la Cultura Física, Universidad Autónoma de Chihuahua, Chihuahua, México.'}]",Atencion primaria,['10.1016/j.aprim.2018.02.008']
3106,29861115,[Effectiveness of an intervention strategy in the biosimilar glargine prescription pattern in primary care].,"OBJECTIVES


To examine the effects of specific interventions on biosimilar glargine insulin (BGI) prescribing in general practices and to analyse the influence of prescriber and economic impact.
DESIGN


Non randomized controlled study.
SETTING


General practices in 2 health areas of Seville, intervention and control group.
PARTICIPANTS


220 general practices (intervention group) and 100 general practices (control group).
INTERVENTION


Intervention group received educational seminars on biosimilar drugs, pharmacotherapeutic bulletin and prescribing feedback. The study was carried out from the biosimilar commercialization, October-2015, to February-2016 (pre-intervention) and from February to August 2016 (intervention).
MAIN MEASUREMENTS


Percentage of patients and DDD with BGI respect to total glargine before and during intervention for both areas were analysed. Physicians have been analysed by subgroups of age, sex, training, type of contract, years of experience and quota.
MAIN RESULTS


Both indicators for intervention group were significantly greater than for control group (P<.0005), with a 95% confidence interval (2.5-4.7). The ratio of the percentage of cumulative increase of both variables between areas was 3.73 times higher after the intervention. No differences were found for the evaluated categories of physicians in the intervention group.
CONCLUSIONS


Intervention strategies aimed at training and information, as well as monitoring health professionals, influence the pattern of prescription and can have an economic impact. Our results have not been influenced by the profile of the prescriber.",2019,"Both indicators for intervention group were significantly greater than for control group (P<.0005), with a 95% confidence interval (2.5-4.7).","['primary care', 'biosimilar commercialization, October-2015, to February-2016 (pre-intervention) and from February to August 2016 (intervention', 'General practices in 2 health areas of Seville, intervention and control group', '220 general practices (intervention group) and 100 general practices (control group']","['biosimilar glargine insulin (BGI', 'specific interventions', 'Intervention group received educational seminars on biosimilar drugs, pharmacotherapeutic bulletin and prescribing feedback']",[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",[],,0.025,"Both indicators for intervention group were significantly greater than for control group (P<.0005), with a 95% confidence interval (2.5-4.7).","[{'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Saborido-Cansino', 'Affiliation': 'Servicio de Farmacia, Área de Gestión Sanitaria Sur, Sevilla, España.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Santos-Ramos', 'Affiliation': 'Servicio de Farmacia, Hospital Universitario Virgen del Rocío, Sevilla, España.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Carmona-Saucedo', 'Affiliation': 'UGC Arahal-Paradas, Arahal, Sevilla, España.'}, {'ForeName': 'María Victoria', 'Initials': 'MV', 'LastName': 'Rodríguez-Romero', 'Affiliation': 'UGC Alcalá de Guadaira, Centro de Salud Don Paulino García Donas, Alcalá de Guadaira, Sevilla, España.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'González-Martín', 'Affiliation': 'UGC San Hilario, Centro de Salud San Hilario, Dos Hermanas, Sevilla, España.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Palma-Amaro', 'Affiliation': 'UGC Dos Hermanas, Centro de Salud Los Montecillos , Dos Hermanas, Sevilla, España.'}, {'ForeName': 'Isabel María', 'Initials': 'IM', 'LastName': 'Rojas-Lucena', 'Affiliation': 'UGC Los Palacios, Centro de Salud San Isidro, Los Palacios y Villafranca, Sevilla, España.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Almeida-González', 'Affiliation': 'Bioestadística, Hospital Universitario Valme, Sevilla, España; Departamento de Medicina Preventiva y Salud Pública, Universidad de Sevilla, Sevilla, España.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Sánchez-Fidalgo', 'Affiliation': 'Departamento de Medicina Preventiva y Salud Pública, Universidad de Sevilla, Sevilla, España. Electronic address: fidalgo@us.es.'}]",Atencion primaria,['10.1016/j.aprim.2018.02.012']
3107,32048278,Determining the effective pre-oxygenation interval in obstetric patients using high-flow nasal oxygen and standard flow rate facemask: a biased-coin up-down sequential allocation trial.,"Using biased-coin sequential allocation, we sought to determine the effective time interval in 90% of healthy parturients to achieve a target endpoint end-tidal oxygen of ≥ 90% using standard flow rate facemask and high-flow nasal oxygen. Eighty healthy parturients were randomly assigned to standard facemask (n = 40) or high-flow nasal oxygen (n = 40) groups; half of the parturients in the high-flow nasal oxygen group also used a simple no-flow facemask to minimise air entrainment. The effective time interval for 90% of parturients to achieve the target endpoint for standard facemask was 3.6 min (95%CI 3.3-6.7 min), but could not be estimated for the high-flow nasal oxygen groups with or without an additional simple facemask, as eight minutes was insufficient to achieve the target endpoint for 55% and 92% of parturients, respectively. Furthermore, after three minutes, the target endpoint was reached by 71% in the standard facemask group vs. 0% in the high-flow nasal oxygen groups. After four minutes, the target endpoint was reached by 100% in the standard facemask, 80% in the high-flow nasal oxygen with simple facemask and 67% in the high-flow nasal oxygen groups. Beyond four minutes, there was no improvement in pre-oxygenation success using high-flow nasal oxygen. In conclusion, under the conditions of our study, the effective time interval for 90% of parturients to achieve an end-tidal oxygen ≥ 90% for standard flow rate facemask was estimated to be 3.6 min, but could not be estimated for high-flow nasal oxygen groups even after eight minutes.",2020,"Beyond four minutes, there was no improvement in pre-oxygenation success using high-flow nasal oxygen.","['obstetric patients using high', 'Eighty healthy parturients']","['standard facemask (n\xa0=\xa040) or high-flow nasal oxygen (n\xa0=\xa040) groups; half of the parturients in the high-flow nasal oxygen group also used a simple no-flow facemask to minimise air entrainment', 'flow nasal oxygen and standard flow rate facemask', 'standard flow rate facemask and high-flow nasal oxygen']","['effective time interval', 'pre-oxygenation success']","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",,0.0489449,"Beyond four minutes, there was no improvement in pre-oxygenation success using high-flow nasal oxygen.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Au', 'Affiliation': ""British Columbia Women's Hospital, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Shippam', 'Affiliation': ""British Columbia Women's Hospital, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': ""British Columbia Women's Hospital, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Albert', 'Affiliation': ""Women's Health Research Institute, Vancouver, BC, Canada.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chau', 'Affiliation': ""British Columbia Women's Hospital, University of British Columbia, Vancouver, BC, Canada.""}]",Anaesthesia,['10.1111/anae.14995']
3108,32058351,Effects of Directional Microphone and Noise Reduction on Subcortical and Cortical Auditory-Evoked Potentials in Older Listeners With Hearing Loss.,"OBJECTIVES


Understanding how signal processing influences neural activity in the brain with hearing loss is relevant to the design and evaluation of features intended to alleviate speech-in-noise deficits faced by many hearing aid wearers. Here, we examine whether hearing aid processing schemes that are designed to improve speech-in-noise intelligibility (i.e., directional microphone and noise reduction) also improve electrophysiological indices of speech processing in older listeners with hearing loss.
DESIGN


The study followed a double-blind within-subjects design. A sample of 19 older adults (8 females; mean age = 73.6 years, range = 56-86 years; 17 experienced hearing aid users) with a moderate to severe sensorineural hearing impairment participated in the experiment. Auditory-evoked potentials associated with processing in cortex (P1-N1-P2) and subcortex (frequency-following response) were measured over the course of two 2-hour visits. Listeners were presented with sequences of the consonant-vowel syllable /da/ in continuous speech-shaped noise at signal to noise ratios (SNRs) of 0, +5, and +10 dB. Speech and noise stimuli were pre-recorded using a Knowles Electronics Manikin for Acoustic Research (KEMAR) head and torso simulator outfitted with hearing aids programmed for each listener's loss. The study aid programs were set according to 4 conditions: (1) omnidirectional microphone, (2) omnidirectional microphone with noise reduction, (3) directional microphone, and (4) directional microphone with noise reduction. For each hearing aid condition, speech was presented from a loudspeaker located at 1 m directly in front of KEMAR (i.e., 0° in the azimuth) at 75 dB SPL and noise was presented from a matching loudspeaker located at 1 m directly behind KEMAR (i.e., 180° in the azimuth). Recorded stimulus sequences were normalized for speech level across conditions and presented to listeners over electromagnetically shielded ER-2 ear-insert transducers. Presentation levels were calibrated to match the output of listeners' study aids.
RESULTS


Cortical components from listeners with hearing loss were enhanced with improving SNR and with use of a directional microphone and noise reduction. On the other hand, subcortical components did not show sensitivity to SNR or microphone mode but did show enhanced encoding of temporal fine structure of speech for conditions where noise reduction was enabled.
CONCLUSIONS


These results suggest that auditory-evoked potentials may be useful in evaluating the benefit of different noise-mitigating hearing aid features.",2020,"RESULTS


Cortical components from listeners with hearing loss were enhanced with improving SNR and with use of a directional microphone and noise reduction.","['Older Listeners With Hearing Loss', 'older listeners with hearing loss', 'listeners with hearing loss', '19 older adults (8 females; mean age = 73.6 years, range = 56-86 years; 17 experienced hearing aid users) with a moderate to severe sensorineural hearing impairment participated in the experiment']","['Directional Microphone and Noise Reduction', 'omnidirectional microphone, (2) omnidirectional microphone with noise reduction, (3) directional microphone, and (4) directional microphone with noise reduction', ""consonant-vowel syllable /da/ in continuous speech-shaped noise at signal to noise ratios (SNRs) of 0, +5, and +10 dB. Speech and noise stimuli were pre-recorded using a Knowles Electronics Manikin for Acoustic Research (KEMAR) head and torso simulator outfitted with hearing aids programmed for each listener's loss""]",['Auditory-evoked potentials associated with processing in cortex (P1-N1-P2) and subcortex (frequency-following response'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}]","[{'cui': 'C1709026', 'cui_str': 'Microphone'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0035168'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0015215', 'cui_str': 'Auditory Evoked Potentials'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]",19.0,0.017341,"RESULTS


Cortical components from listeners with hearing loss were enhanced with improving SNR and with use of a directional microphone and noise reduction.","[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Slugocki', 'Affiliation': 'Widex Office of Research in Clinical Amplification (ORCA-USA), Lisle, Illinois, USA.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Kuk', 'Affiliation': 'Widex Office of Research in Clinical Amplification (ORCA-USA), Lisle, Illinois, USA.'}, {'ForeName': 'Petri', 'Initials': 'P', 'LastName': 'Korhonen', 'Affiliation': 'Widex Office of Research in Clinical Amplification (ORCA-USA), Lisle, Illinois, USA.'}]",Ear and hearing,['10.1097/AUD.0000000000000847']
3109,32058435,Does Preoperative Decolonization Reduce Surgical Site Infections in Elective Orthopaedic Surgery? A Prospective Randomized Controlled Trial.,"BACKGROUND


Surgical site infections (SSIs) after elective orthopaedic surgery are very stressful for patients due to frequent rehospitalizations with reoperations and poorer functional outcomes. Prevention of such events is therefore crucial. Although an evidence-based consensus is still lacking, preoperative decolonization could decrease SSI. Specifically, more information is needed about the effect of a preoperative decolonization procedure on SSI proportions in both Staphylococcus aureus carriers and non-S. aureus carriers after general orthopaedic surgery.
QUESTIONS/PURPOSES


Our study addressed the following questions: (1) Does preoperative decolonization reduce the risk of SSI after general elective orthopaedic surgery in patients colonized with S. aureus? (2) Does preoperative decolonization reduce the risk of SSI among patients who are not colonized with S. aureus?
METHODS


In this prospective, randomized, single-blinded trial, we recruited patients undergoing general elective orthopaedic surgery in one tertiary care center in Switzerland. Between November 2014 and September 2017, 1318 of 1897 screened patients were enrolled. Patients were allocated into either the S. aureus carrier group (35%, 465 of 1318 patients) or the noncarrier group (65%, 853 of 1318 patients) according to screening culture results. In the S. aureus group, 232 patients were allocated to the intervention arm and 233 were allocated to the control arm. Intervention was 5 days of daily chlorhexidine showers and mupirocin nasal ointment twice a day. Of the 853 noncarriers, 426 were allocated to the intervention arm and 427 were allocated to the control arm. All patients in both groups were analyzed in an intention-to-treat manner. The primary endpoint was SSI occurrence at 90 days postoperative and the secondary endpoint was SSI occurrence at 30 days postoperative.The initial sample size calculation was made for the S. aureus carrier group. Based on the literature review, a 4% proportion of SSI was expected in the control group. Thus, 726 carriers would have been needed to detect a relative risk reduction of 80% with a power of 80% at a two-sided α-error of 0.048 (adjusted for interim analysis). Assuming carrier prevalence of 27%, 2690 patients would have been needed in total. An interim analysis was performed after including half of the targeted S. aureus carriers (363 of 726). Based on the low infection rate in the control group (one of 179), a new sample size of 15,000 patients would have been needed. This was deemed not feasible and the trial was stopped prematurely.
RESULTS


Among carriers, there was no difference in the risk of SSI between the intervention and control arms (decolonized SSI risk: 0.4% [one of 232], control SSI risk: 0.4% [one of 233], risk difference: 0.0% [95% CI -1.2% to 1.2%], stratified for randomization stratification factors; p > 0.999). For noncarriers, there was no difference in risk between the intervention and control arms (decolonized SSI risk: 0.2% [one of 426], control SSI risk: 0.2% [one of 247], stratified risk difference: -0.0% [95% CI -0.7 to 0.6]; p = 0.973).
CONCLUSIONS


We found no difference in the risk of SSI between the decolonization and control groups, both in S. aureus carriers and noncarriers. Because of the low event numbers, no definite conclusion about efficacy of routine preoperative decolonization can be drawn. The results, however, may be helpful in future meta-analyses.
LEVEL OF EVIDENCE


Level II, therapeutic study.",2020,"For non-carriers, there was no difference in risk between the intervention and control arms (decolonized SSI risk: 0.2% [one of 426], control SSI risk: 0.2% [one of 247], stratified risk difference:","['232 patients', '853 non-carriers, 426 were allocated to the intervention arm and 427', 'Between November 2014 and September 2017, 1318 of 1897 screened patients were enrolled', 'patients undergoing general elective orthopaedic surgery in one tertiary care center in Switzerland']",['chlorhexidine'],"['low infection rate', 'SSI occurrence', 'risk of SSI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0039021', 'cui_str': 'Switzerland'}]","[{'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",15000.0,0.109456,"For non-carriers, there was no difference in risk between the intervention and control arms (decolonized SSI risk: 0.2% [one of 426], control SSI risk: 0.2% [one of 247], stratified risk difference:","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Rohrer', 'Affiliation': 'F. Rohrer, P. Cottagnoud, T. Hermann, J. Brügger, Department of Internal Medicine, Sonnenhofspital, Bern, Switzerland F. Rohrer, H. Nötzli, L. Risch, P. Cottagnoud, University of Bern, Bern, Switzerland H. Nötzli, Orthopaedic Department, Sonnenhofspital, Bern, Switzerland L. Risch, T. Bodmer, Labormedizinisches Zentrum Dr Risch, Microbiology, Koeniz, Switzerland A. Limacher, N. Fankhauser, CTU Bern and Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland K. Wagner, Institute of Medical Microbiology, University of Zurich, Zurich, Switzerland J. Brügger, University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Nötzli', 'Affiliation': ''}, {'ForeName': 'Lorenz', 'Initials': 'L', 'LastName': 'Risch', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bodmer', 'Affiliation': ''}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cottagnoud', 'Affiliation': ''}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Hermann', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Limacher', 'Affiliation': ''}, {'ForeName': 'Niklaus', 'Initials': 'N', 'LastName': 'Fankhauser', 'Affiliation': ''}, {'ForeName': 'Karoline', 'Initials': 'K', 'LastName': 'Wagner', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Brügger', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000001152']
3110,32053538,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Knackstedt', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gatherwright', 'Affiliation': ''}, {'ForeName': 'Risal', 'Initials': 'R', 'LastName': 'Djohan', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006782']
3111,32053534,"Reply to: ""The Analgesic Effects of Liposomal Bupivacaine versus Bupivacaine Hydrochloride Administered as a Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction: A Prospective, Single-Blind, Randomized, Controlled Trial"".",,2020,,['Transversus Abdominis Plane Block after Abdominally Based Autologous Microvascular Breast Reconstruction'],"['Bupivacaine Hydrochloride', 'Liposomal Bupivacaine']",[],"[{'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0085076', 'cui_str': 'Breast Reconstruction'}]","[{'cui': 'C0887621', 'cui_str': 'Bupivacaine Hydrochloride'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]",[],,0.155102,,"[{'ForeName': 'Austin Y', 'Initials': 'AY', 'LastName': 'Ha', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Guffey', 'Affiliation': 'Department of Anesthesiology, Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Myckatyn', 'Affiliation': 'Division of Plastic and Reconstructive Surgery, Washington University School of Medicine, Saint Louis, MO.'}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006783']
3112,31713350,"Phase 1 Dose-Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Tofacitinib in Japanese Healthy Volunteers.","The aim of the study was to characterize the pharmacokinetics, safety, and tolerability of tofacitinib, an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis in healthy Japanese volunteers, and to compare these outcomes with those of healthy Western volunteers. Twenty-five volunteers (Japanese, n = 16; Western [white], n = 9) were randomized to receive either 3 escalating single doses of tofacitinib (1, 5, and 30 mg), single-dose tofacitinib (15 mg) followed by multiple doses (15 mg twice daily for 5 days), or placebo. No significant differences in systemic exposure to tofacitinib were detected between the 2 ethnicities. Following single tofacitinib 1, 5, and 30 mg doses, mean area under the plasma concentration-time curve from time zero to infinity ratio (Japanese/Western) values were 96.6%, 93.5%, and 95.6%, respectively. Similarly, mean maximum observed plasma concentration ratio values were 99.5%, 118%, and 119%, respectively. Mean renal clearance was also similar, ranging across doses from 134 mL/min (5 mg) to 162 mL/min (1 mg) in Japanese volunteers, and 124 mL/min (30 mg) to 160 mL/min (1 mg) in Western volunteers. In both ethnicities, most adverse events were mild. No serious adverse events or deaths were reported. The pharmacokinetics of tofacitinib were well characterized in healthy Japanese volunteers and were similar to those in Western volunteers.",2020,The pharmacokinetics of tofacitinib were well characterized in healthy Japanese volunteers and were similar to those in Western volunteers.,"['healthy Western volunteers', 'Twenty-five volunteers (Japanese, n\xa0=\xa016; Western [white], n\xa0=\xa09', 'Japanese Healthy Volunteers', 'healthy Japanese volunteers and were similar to those in Western volunteers', 'healthy Japanese volunteers']","['tofacitinib (1,\xa05,\xa0and 30\xa0mg), single-dose tofacitinib', 'tofacitinib', 'oral Janus kinase inhibitor', 'placebo', 'Tofacitinib']","['pharmacokinetics, safety, and tolerability', 'systemic exposure to tofacitinib', 'Pharmacokinetics, Safety, and Tolerability', 'plasma concentration ratio values', 'Mean renal clearance', 'serious adverse events or deaths', 'mean area under the plasma concentration-time curve from time zero to infinity ratio (Japanese/Western) values']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4521962', 'cui_str': 'Janus kinase inhibitor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C2930696', 'cui_str': 'tofacitinib'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1532109', 'cui_str': 'Ratio value'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0232813', 'cui_str': 'Renal clearance, function (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",25.0,0.0252806,The pharmacokinetics of tofacitinib were well characterized in healthy Japanese volunteers and were similar to those in Western volunteers.,"[{'ForeName': 'So', 'Initials': 'S', 'LastName': 'Miyoshi', 'Affiliation': 'Pfizer Japan Inc, Tokyo, Japan.'}, {'ForeName': 'Sriram', 'Initials': 'S', 'LastName': 'Krishnaswami', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Toyoizumi', 'Affiliation': 'Pfizer Japan Inc, Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Pfizer Japan Inc, Tokyo, Japan.'}, {'ForeName': 'Samuel H', 'Initials': 'SH', 'LastName': 'Zwillich', 'Affiliation': 'Pfizer Inc, Groton, Connecticut, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.741']
3113,31200349,Maintenance of Fitness and Quality-of-Life Benefits From Supervised Exercise Offered as Supportive Care for Breast Cancer.,"BACKGROUND


Overwhelming randomized controlled trial evidence demonstrates that exercise has positive health impacts during and after treatment for breast cancer. Yet, evidence generated by studies in which exercise programs are delivered outside a tightly controlled randomized trial setting is limited. The purpose of this study was to assess the effectiveness of an evidence-based exercise program with real-world implementation on physical fitness and quality of life (QoL).
PATIENTS AND METHODS


Oncologists referred women with early-stage breast cancer who were scheduled to receive adjuvant chemotherapy. The program consisted of supervised aerobic and resistance exercise of moderate to vigorous intensity 3 times per week until the end of treatment (chemotherapy ± radiotherapy), then twice per week for 10 weeks, followed by once per week for 10 weeks. Health-related physical fitness and QoL were assessed at baseline, end of treatment, end of program, and 1-year follow-up.
RESULTS


A total of 73 women were enrolled. Estimated peak VO2 (VO2peak), QoL, and body weight were maintained between baseline and end of treatment, whereas muscular strength improved (P<.01). By the end of the program, VO2peak, heart rate recovery, waist circumference, and some aspects of QoL were improved (all P<.01) relative to baseline. One year later, VO2peak, QoL, and waist circumference were maintained relative to end of program, whereas the improvements in strength and heart rate recovery had dissipated (all P<.01).
CONCLUSIONS


Evidence-based exercise programming delivered with real-world implementation maintained VO2peak, strength, and QoL during adjuvant treatment and improved these measures after treatment completion among women with breast cancer. Continued guidance and support may be required for long-term maintenance of strength improvements in this population.",2019,"Estimated peak VO2 (VO2peak), QoL, and body weight were maintained between baseline and end of treatment, whereas muscular strength improved (P<.01).","['women with breast cancer', 'breast cancer', 'A total of 73 women were enrolled', 'Oncologists referred women with early-stage breast cancer who were scheduled to receive']","['evidence-based exercise program with real-world implementation', 'supervised aerobic and resistance exercise of moderate to vigorous intensity 3 times per week until the end of treatment (chemotherapy ± radiotherapy', 'adjuvant chemotherapy']","['VO2peak, heart rate recovery, waist circumference, and some aspects of QoL', 'strength and heart rate recovery', 'muscular strength', 'physical fitness and quality of life (QoL', 'Maintenance of Fitness and Quality-of-Life Benefits', 'Estimated peak VO2 (VO2peak), QoL, and body weight', 'VO2peak, QoL, and waist circumference']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0034380'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1701256', 'cui_str': 'bis(acetylacetonato)oxovanadium(IV)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",73.0,0.0897266,"Estimated peak VO2 (VO2peak), QoL, and body weight were maintained between baseline and end of treatment, whereas muscular strength improved (P<.01).","[{'ForeName': 'Amy A', 'Initials': 'AA', 'LastName': 'Kirkham', 'Affiliation': 'University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Kelcey A', 'Initials': 'KA', 'LastName': 'Bland', 'Affiliation': 'Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Wollmann', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Alis', 'Initials': 'A', 'LastName': 'Bonsignore', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada; and.'}, {'ForeName': 'Don C', 'Initials': 'DC', 'LastName': 'McKenzie', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Cheri', 'Initials': 'C', 'LastName': 'Van Patten', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Gelmon', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Campbell', 'Affiliation': 'University of British Columbia, Vancouver, British Columbia, Canada.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2018.7276']
3114,31200357,Cost-Effectiveness of Cabozantinib in the Second-Line Treatment of Advanced Hepatocellular Carcinoma.,"BACKGROUND


Treatment options are limited for patients with advanced hepatocellular carcinoma (HCC) that progresses after treatment with sorafenib. Cabozantinib, an oral small molecule inhibitor of multiple tyrosine kinase receptors, recently showed improved overall survival (OS) compared with placebo in sorafenib-pretreated patients with advanced HCC in the CELESTIAL trial. This study assessed the cost-effectiveness of cabozantinib for second-line treatment of patients with advanced HCC from a US healthcare system perspective.
PATIENTS AND METHODS


Cost and utility data were extracted from the CELESTIAL trial and used to determine the cost-effectiveness of cabozantinib compared with placebo plus best supportive care. The main outcome of this study was the incremental cost-effectiveness ratio (ICER), expressed as cost per quality-adjusted life year (QALY) gained by using cabozantinib compared with placebo plus best supportive care in sorafenib-pretreated HCC.
RESULTS


In the base-case analysis using data from the CELESTIAL trial, the incremental QALY and ICER were 0.067 and $1,040,675 for cabozantinib compared with placebo and best supportive care. OS reported in the CELESTIAL trial (hazard ratio, 0.76; 95% CI, 0.63-0.92) had the strongest association with the ICER. In one-way sensitivity analyses, there were no scenarios in which cabozantinib was cost-effective. In a cost-threshold analysis, cabozantinib would have to be priced at least $50 per pill to be cost-effective considering a willingness to pay of $100,000 per QALY. Although the CELESTIAL trial demonstrated that cabozantinib improves OS compared with placebo in patients with HCC that progresses after treatment with sorafenib, our analysis shows that cabozantinib is not a cost-effective therapy in this scenario.
CONCLUSIONS


At current costs, cabozantinib is not cost-effective for second-line therapy of HCC in the United States.",2019,"OS reported in the CELESTIAL trial (hazard ratio, 0.76; 95% CI, 0.63-0.92) had the strongest association with the ICER.","['Advanced Hepatocellular Carcinoma', 'patients with advanced HCC from a US healthcare system perspective', 'patients with HCC', 'patients with advanced hepatocellular carcinoma (HCC']","['sorafenib', 'Cabozantinib', 'placebo', 'cabozantinib']","['cost-effectiveness', 'incremental cost-effectiveness ratio (ICER), expressed as cost per quality-adjusted life year (QALY', 'overall survival (OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}]","[{'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.192508,"OS reported in the CELESTIAL trial (hazard ratio, 0.76; 95% CI, 0.63-0.92) had the strongest association with the ICER.","[{'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Soto-Perez-de-Celis', 'Affiliation': 'Department of Geriatrics, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.'}, {'ForeName': 'Pedro N', 'Initials': 'PN', 'LastName': 'Aguiar', 'Affiliation': 'Centro de Estudos e Pesquisa de Hematologia e Oncologia, Faculdade de Medicina do ABC, Santo André, Brazil.'}, {'ForeName': 'Mónica L', 'Initials': 'ML', 'LastName': 'Cordón', 'Affiliation': 'Department of Hemato-Oncology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; and.'}, {'ForeName': 'Yanin', 'Initials': 'Y', 'LastName': 'Chavarri-Guerra', 'Affiliation': 'Department of Hemato-Oncology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico; and.'}, {'ForeName': 'Gilberto de Lima', 'Initials': 'GL', 'LastName': 'Lopes', 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida.'}]",Journal of the National Comprehensive Cancer Network : JNCCN,['10.6004/jnccn.2018.7275']
3115,32014696,Trainee Performance After Laparoscopic Simulator Training Using a Blackbox versus LapMentor.,"BACKGROUND


Training using laparoscopic high-fidelity simulators (LHFSs) to proficiency levels improves laparoscopic cholecystectomy skills. However, high-cost simulators and their limited availability could negatively impact residents' laparoscopic training opportunities. We aimed to assess whether motivation and surgical skill performance differ after basic skills training (BST) using a low-cost (Blackbox) versus LHFS (LapMentor) among medical students.
MATERIALS AND METHODS


Sixty-three medical students from Karolinska Institutet volunteered, completing written informed consent, questionnaire regarding expectations of the simulation training, and a visuospatial ability test. They were randomized into two groups that received BST using Blackbox (n = 32) or LapMentor (n = 31). However, seven students absence resulted in 56 participants, followed by another 9 dropouts. Subsequently, after training, 47 students took up three consecutive tests using the minimally invasive surgical trainer-virtual reality (MIST-VR) simulator, finalizing a questionnaire.
RESULTS


More Blackbox group participants completed all MIST-VR tests (29/31 versus 18/25). Students anticipated mastering LapMentor would be more difficult than Blackbox (P = 0.04). In those completing the simulation training, a trend toward an increase was noted in how well participants in the Blackbox group liked the simulator training (P = 0.07). Subgroup analysis of motivation and difficulty in liking the training regardless of simulator was found only in women (Blackbox [P = 0.02]; LapMentor [P = 0.06]). In the Blackbox group, the perceived difficulty of training, facilitation, and liking the Blackbox training (significant only in women) were significantly correlated with the students' performance in the MIST-simulator. No such correlations were found in the LapMentor group.
CONCLUSIONS


Results indicate an important role for low-tech/low-cost Blackbox laparoscopic BST of students in an otherwise high-tech surrounding. Furthermore, experience of Blackbox BST procedures correlate with students' performance in the MIST-VR simulator, with some gender-specific differences.",2020,"In those completing the simulation training, a trend toward an increase was noted in how well participants in the Blackbox group liked the simulator training (P = 0.07).","['Sixty-three medical students from Karolinska Institutet volunteered, completing written informed consent, questionnaire regarding expectations of the simulation training, and a visuospatial ability test', '47 students took up three consecutive tests using the', 'medical students']","['minimally invasive surgical trainer-virtual reality (MIST-VR) simulator, finalizing a questionnaire', 'Blackbox versus LapMentor', 'Blackbox', 'Training using laparoscopic high-fidelity simulators (LHFSs', 'basic skills training (BST) using a low-cost (Blackbox) versus LHFS (LapMentor', 'BST using Blackbox', 'LapMentor']","['perceived difficulty of training, facilitation, and liking the Blackbox training', 'MIST-VR tests', 'Trainee Performance']","[{'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0183309', 'cui_str': 'Simulator (physical object)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]","[{'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",63.0,0.0271268,"In those completing the simulation training, a trend toward an increase was noted in how well participants in the Blackbox group liked the simulator training (P = 0.07).","[{'ForeName': 'Ninos', 'Initials': 'N', 'LastName': 'Oussi', 'Affiliation': 'Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden; Centre for Clinical Research Sörmland, Uppsala University, Eskilstuna, Sweden; Center for Advanced Medical Simulation and Training, Karolinska University Hospital, Stockholm, Sweden. Electronic address: ninos.oussi@ki.se.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Enochsson', 'Affiliation': 'Center for Advanced Medical Simulation and Training, Karolinska University Hospital, Stockholm, Sweden; Division of Surgery, Department of Surgical and Perioperative Sciences, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Henningsohn', 'Affiliation': 'Center for Advanced Medical Simulation and Training, Karolinska University Hospital, Stockholm, Sweden; Division of Urology, CLINTEC, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Castegren', 'Affiliation': 'Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden; Perioperative Medicine and Intensive Care (PMI), Karolinska University Hospital, Sweden.'}, {'ForeName': 'Evangelos', 'Initials': 'E', 'LastName': 'Georgiou', 'Affiliation': 'Medical Physics Laboratory and Simulation Center, Medical School, University of Athens, Athens, Greece.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Kjellin', 'Affiliation': 'Division of Surgery, CLINTEC, Karolinska Institutet, Stockholm, Sweden; Center for Advanced Medical Simulation and Training, Karolinska University Hospital, Stockholm, Sweden.'}]",The Journal of surgical research,['10.1016/j.jss.2019.12.039']
3116,23038758,Predictive impact of RRM1 protein expression on vinorelbine efficacy in NSCLC patients randomly assigned in a chemotherapy phase III trial.,"BACKGROUND


Platinum-based doublets (PBDs) remain the cornerstone of treatment in non-small-cell lung cancer (NSCLC) and may include gemcitabine. A biomarker predicting sensitivity to this antimetabolite would represent a major step forward. Accordingly, we explored the predictive role of ribonucleotide reductase subunit M (RRM1) in advanced NSCLC.
PATIENTS AND METHODS


A total of 443 patients were randomly assigned to regimen A [paclitaxel (Taxol) and cisplatin with gemcitabine] or regimen B (cisplatin and vinorelbine). Immunohistochemical evaluation of RRM1 was correlated to clinical end-points.
RESULTS


A total of 261 (58.9%) patients had representative tissue samples for RRM1 evaluation. Disease control rate, progression-free survival (PFS) and overall survival (OS) were substantially improved in patients with RRM-negative (neg) tumors receiving regimen B when compared with patients with RRM-positive (pos) tumors (68.8% versus 31.2%, P = 0.046, 6.90 months versus 3.93 months, P = 0.000 and 11.57 months versus 7.4 months, P = 0.002, respectively). Interaction analysis between RRM1-neg status and adenocarcinomas yielded a hazard ratio (HR) of 0.36 for death (P = 0.000).
CONCLUSIONS


RRM1 protein expression was without any predictive impact in patients treated with cisplatin, paclitaxel and gemcitabine. Surprisingly, the predictive power was demonstrated in the cisplatin and vinorelbine arm and may suggest that RRM1 is involved in vinorelbine sensitivity warranting further research.",2013,"Disease control rate, progression-free survival (PFS) and overall survival (OS) were substantially improved in patients with RRM-negative (neg) tumors receiving regimen B when compared with patients with RRM-positive (pos) tumors (68.8% versus 31.2%, P = 0.046, 6.90 months versus 3.93 months, P = 0.000 and 11.57 months versus 7.4 months, P = 0.002, respectively).","['A total of 261 (58.9%) patients had representative tissue samples for RRM1 evaluation', 'A total of 443 patients', 'NSCLC patients randomly assigned in a chemotherapy phase III trial']","['gemcitabine', 'cisplatin and vinorelbine', 'cisplatin, paclitaxel and gemcitabine', 'regimen A [paclitaxel (Taxol) and cisplatin with gemcitabine', 'regimen B (cisplatin and vinorelbine', 'Platinum-based doublets (PBDs', 'ribonucleotide reductase subunit M (RRM1']","['Disease control rate, progression-free survival (PFS) and overall survival (OS', 'Immunohistochemical evaluation of RRM1', 'vinorelbine efficacy']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035547', 'cui_str': 'Ribonucleotide Reductase'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}]",443.0,0.0912646,"Disease control rate, progression-free survival (PFS) and overall survival (OS) were substantially improved in patients with RRM-negative (neg) tumors receiving regimen B when compared with patients with RRM-positive (pos) tumors (68.8% versus 31.2%, P = 0.046, 6.90 months versus 3.93 months, P = 0.000 and 11.57 months versus 7.4 months, P = 0.002, respectively).","[{'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Vilmar', 'Affiliation': 'Departments of Oncology 5073, Finsen Centre, Copenhagen. Electronic address: adamvilmar@hotmail.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Santoni-Rugiu', 'Affiliation': 'Department of Pathology 5442, Diagnostic Center, National University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Sorensen', 'Affiliation': 'Departments of Oncology 5073, Finsen Centre, Copenhagen.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds335']
3117,32044268,Prospective double-blinded randomized controlled trial of Microwave versus RadioFrequency Ablation for hepatocellular carcinoma (McRFA trial).,"BACKGROUND


Microwave (MWA) and radiofrequency ablation are the commonly used local ablation for hepatocellular carcinoma (HCC). Studies comparing both techniques are scarce. The aim of this study was to compare the efficacy of MWA versus RFA as a treatment for HCC.
METHODS


Patients with HCC who were suitable for local ablation were randomized into MWA or RFA. All patients were followed up regularly with contrast-enhanced computed tomography (CT) performed at 1, 3, 6 and 12 months after ablation. Both patients and the radiologists who interpreted the post-procedure CT scans were blinded to the treatment allocation. Treatment-related morbidity, overall and disease-free survivals were analyzed.
RESULTS


A total of 93 patients were recruited. Among them, 47 and 46 patients were randomized to MWA and RFA respectively. Patients in two groups were comparable in baseline demographics and tumor characteristics. With a median follow-up of around 30 months, there were no significant difference in the treatment-related morbidity, overall and disease-free survivals. MWA had a significantly shorter overall ablation time when compared with RFA (12 min vs 24 min, p < 0.001).
CONCLUSIONS


MWA is no different to RFA with respect to completeness of ablation and survivals. It is, however, as safe and effective as RFA in treating small HCC.",2020,"MWA had a significantly shorter overall ablation time when compared with RFA (12 min vs 24 min, p < 0.001).
","['A total of 93 patients were recruited', 'hepatocellular carcinoma (McRFA trial', 'hepatocellular carcinoma (HCC', 'Among them, 47 and 46 patients', 'Patients with HCC who were suitable for local ablation']","['MWA versus RFA', 'Microwave versus RadioFrequency Ablation', 'MWA', 'MWA or RFA', 'Microwave (MWA) and radiofrequency ablation']","['Treatment-related morbidity, overall and disease-free survivals', 'overall ablation time', 'treatment-related morbidity, overall and disease-free survivals']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0026051', 'cui_str': 'Microwaves'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",93.0,0.104477,"MWA had a significantly shorter overall ablation time when compared with RFA (12 min vs 24 min, p < 0.001).
","[{'ForeName': 'Charing C N', 'Initials': 'CCN', 'LastName': 'Chong', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong. Electronic address: chongcn@surgery.cuhk.edu.hk.'}, {'ForeName': 'Kit F', 'Initials': 'KF', 'LastName': 'Lee', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Sunny Y S', 'Initials': 'SYS', 'LastName': 'Cheung', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Clement C M', 'Initials': 'CCM', 'LastName': 'Chu', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, the Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Anthony K W', 'Initials': 'AKW', 'LastName': 'Fong', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wong', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Joyce W Y', 'Initials': 'JWY', 'LastName': 'Hui', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, the Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Andrew K Y', 'Initials': 'AKY', 'LastName': 'Fung', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Hon T', 'Initials': 'HT', 'LastName': 'Lok', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Eugene Y J', 'Initials': 'EYJ', 'LastName': 'Lo', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Chan', 'Affiliation': 'Department of Clinical Oncology, Prince of Wales Hospital, the Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Simon C H', 'Initials': 'SCH', 'LastName': 'Yu', 'Affiliation': 'Department of Imaging & Interventional Radiology, Prince of Wales Hospital, the Chinese University of Hong Kong, Hong Kong.'}, {'ForeName': 'Kelvin K C', 'Initials': 'KKC', 'LastName': 'Ng', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Paul B S', 'Initials': 'PBS', 'LastName': 'Lai', 'Affiliation': 'Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong, Shatin, Hong Kong.'}]",HPB : the official journal of the International Hepato Pancreato Biliary Association,['10.1016/j.hpb.2020.01.008']
3118,30921502,"Safety Profiles, Pharmacokinetics, and Changes in Bone Turnover Markers After Twice-Weekly Subcutaneous Administration of Teriparatide in Healthy Japanese Postmenopausal Women: A Single-Blind Randomized Study.","Once-weekly injection of 56.5-μg teriparatide formulation is a potent therapeutic agent for osteoporosis treatment. However, this treatment has an issue of difficulty in continuing the treatment by its adverse side effects including nausea, vomiting, and headaches. To reduce these adverse side effects, we conducted a randomized, single-blind, placebo-controlled study to examine the pharmacokinetics, changes in bone turnover markers, and safety profiles of twice-weekly 28.2-μg teriparatide injections. Different dosing intervals of the twice-weekly 28.2-μg injections were also studied. A total of 100 healthy Japanese postmenopausal women were enrolled in this multiple-dosing study. The systemic exposure of teriparatide acetate in the twice-weekly 28.2-μg injection was half that of the once-weekly 56.5-μg injection. Changes in bone turnover markers in the twice-weekly 28.2-μg injection were comparable to those in the once-weekly 56.5-μg injection. Incidences of adverse events including nausea, vomiting, and headaches were lower in the twice-weekly 28.2-μg injections than those in the once-weekly 56.5-μg injection. Findings were similar in the twice-weekly 28.2-μg injections regardless of the dosing interval. Thus, the new dosing regimen using twice-weekly 28.2-μg injections maintained comparable efficacy to the once-weekly 56.5-μg injections; however, it improved the safety profile and contributed to better continuity of care with teriparatide.",2020,"Incidences of adverse events including nausea, vomiting, and headaches were lower in the twice-weekly 28.2-μg injections than those in the once-weekly 56.5-μg injection.","['Healthy Japanese Postmenopausal Women', '100 healthy Japanese postmenopausal women']","['teriparatide', 'Teriparatide', 'placebo', '56.5-μg teriparatide formulation', 'teriparatide acetate']","['bone turnover markers, and safety profiles', 'Safety Profiles, Pharmacokinetics, and Changes in Bone Turnover Markers', 'bone turnover markers', 'nausea, vomiting, and headaches', 'adverse side effects']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376564', 'cui_str': 'Teriparatide Acetate'}]","[{'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",100.0,0.0686346,"Incidences of adverse events including nausea, vomiting, and headaches were lower in the twice-weekly 28.2-μg injections than those in the once-weekly 56.5-μg injection.","[{'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Kumagai', 'Affiliation': 'Kitasato University East Hospital, Kanagawa, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Ose', 'Affiliation': 'Development Planning, Clinical Development Center, Asahi Kasei Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Development Planning, Clinical Development Center, Asahi Kasei Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Toshitsugu', 'Initials': 'T', 'LastName': 'Sugimoto', 'Affiliation': 'Internal Medicine 1, Shimane University Faculty of Medicine, Shimane, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.687']
3119,23117071,Growth modulation index as metric of clinical benefit assessment among advanced soft tissue sarcoma patients receiving trabectedin as a salvage therapy.,"BACKGROUND


The growth modulation index (GMI) is the ratio of time to progression with the nth line (TTP(n)) of therapy to the TTP(n)(-1) with the n-1th line. GMI >1.33 is considered as a sign of activity in phase II trials.
PATIENTS AND METHODS


This retrospective analysis evaluated the concordance between the GMI and the efficacy outcomes in 279 patients with advanced soft tissue sarcoma (ASTS) treated with trabectedin 1.5 mg/m² (24-h infusion every 3 weeks) in four phase II trials.
RESULTS


One hundred and forty-two (51%) patients received one prior line and 137 ≥ 2 lines. The median TTP(n) was 2.8 months (range 0.2-26.8), whereas the median TTP(n)(-1) was 4.0 months (0.3-79.5). The median GMI was 0.6 (0.0-14.4). Overall, 177 patients (63%) had a GMI <1; 21 (8%) a GMI equal to 1-1.33 and 81 (29%) a GMI >1.33, which correlated with the median overall survival in those patients (9.1, 13.9 and 23.8 months, respectively, P = 0.0005). A high concordance rate between the GMI and response rate (P < 0.0001) and progression-free survival (PFS, P < 0.0001) was observed. Good performance status (PS) was the only factor associated with GMI >1.33 (PS = 0; P < 0.04).
CONCLUSIONS


A high GMI was associated with favorable efficacy outcomes in patients treated with trabectedin. Further research is needed to assess GMI as an indicator in this setting.",2013,"A high concordance rate between the GMI and response rate (P < 0.0001) and progression-free survival (PFS, P < 0.0001) was observed.","['advanced soft tissue sarcoma patients receiving trabectedin as a salvage therapy', '279 patients with advanced soft tissue sarcoma (ASTS) treated with', 'One hundred and forty-two (51%) patients received one prior line and 137 ≥ 2 lines']",['trabectedin 1.5 mg/m²'],"['GMI and response rate', 'median overall survival', 'Good performance status (PS', 'progression-free survival', 'median TTP(n', 'GMI equal', 'median GMI']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C0085405', 'cui_str': 'Salvage Treatment'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}]","[{'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]",279.0,0.0316275,"A high concordance rate between the GMI and response rate (P < 0.0001) and progression-free survival (PFS, P < 0.0001) was observed.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Penel', 'Affiliation': 'Medical Oncology Department, Centre Oscar Lambret, Lille, France. Electronic address: n-penel@o-lambret.fr.'}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Demetri', 'Affiliation': 'Medical Oncology Department, Ludwig Center at Dana-Farber Cancer Institute, Boston, USA.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Medical Oncology Department, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cousin', 'Affiliation': 'Medical Oncology Department, Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Maki', 'Affiliation': 'Medical Oncology Department,Mount Sinai School of Medicine, New York.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Chawla', 'Affiliation': 'Medical Oncology Department, Santa Monica Oncology Center Santa Monica, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Judson', 'Affiliation': 'Medical Oncology Department, Royal Marsden Hospital, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'von Mehren', 'Affiliation': 'Medical Oncology Department, Fox Chase Cancer Center, Philadelphia, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'Medical Oncology Department, University Hospital Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Verweij', 'Affiliation': 'Medical Oncology Department, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Casali', 'Affiliation': 'Medical Oncology Department, Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rodenhuis', 'Affiliation': 'Medical Oncology Department, The Netherlands Cancer Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Schütte', 'Affiliation': 'Medical Oncology Department, Marien Hospital, Dûsseldorf, Deutschland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cassar', 'Affiliation': 'Scientific liaison office, Novex Pharma, Levallois-Perret, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gomez', 'Affiliation': 'Statistics Department & Medical affairs, Pharmamar, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nieto', 'Affiliation': 'Statistics Department & Medical affairs, Pharmamar, Madrid, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Zintl', 'Affiliation': 'Statistics Department & Medical affairs, Pharmamar, Madrid, Spain.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Pontes', 'Affiliation': 'Statistics Department & Medical affairs, Pharmamar, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Le Cesne', 'Affiliation': 'Medical Oncology Department, Institut Gustave Roussy, Villejuif, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds470']
3120,23123509,Safety and efficacy of weekly nab®-paclitaxel in combination with carboplatin as first-line therapy in elderly patients with advanced non-small-cell lung cancer.,"BACKGROUND


This analysis evaluates safety and efficacy in elderly (≥ 70 years old) versus younger patients enrolled in a phase III advanced non-small-cell lung cancer (NSCLC) trial.
PATIENTS AND METHODS


Untreated stage IIIB/IV patients with PS 0/1 were randomly assigned (1:1) to carboplatin AUC6, day 1 every 3 weeks, and either nab-paclitaxel (Abraxane) 100 mg/m(2) weekly (nab-P/C) or solvent-based paclitaxel (Taxol) 200 mg/m(2) day 1 every 3 weeks (sb-P/C). The primary end-point was overall response rate (ORR).
RESULTS


Fifteen percent of 1052 enrolled patients were elderly: nab-P/C, n = 74; sb-P/C, n = 82. In both age cohorts, the ORR was higher with nab-P/C versus sb-P/C (age ≥ 70: 34% versus 24%, P = 0.196; age <70: 32% versus 25%, P = 0.013). In elderly patients, progression-free survival (PFS) trended in favor of nab-P/C (median 8.0 versus 6.8 months, hazard ratio (HR) 0.687, P = 0.134), and overall survival (OS) was significantly improved (median 19.9 versus 10.4 months, HR 0.583, P = 0.009). In younger patients, PFS (median 6.0 versus 5.8 months, HR 0.903, P = 0.256) and OS (median 11.4 versus 11.3 months, HR 0.999, P = 0.988) were similar in both arms. Adverse events were similar in both age groups, with less neutropenia (P = 0.015), neuropathy (P = 0.001), and arthralgia (P = 0.029), and increased anemia (P = 0.007) with nab-P/C versus sb-P/C.
CONCLUSIONS


In elderly NSCLC patients, nab-P/C as first-line therapy was well tolerated and improved the ORR and PFS, with substantially longer OS versus sb-PC.",2013,"Adverse events were similar in both age groups, with less neutropenia (P = 0.015), neuropathy (P = 0.001), and arthralgia (P = 0.029), and increased anemia (P = 0.007) with nab-P/C versus sb-P/C.
CONCLUSIONS


","['Fifteen percent of 1052 enrolled patients were elderly: nab-P/C, n = 74; sb-P/C, n = 82', 'elderly patients with advanced non-small-cell lung cancer', 'Untreated stage IIIB/IV patients with PS 0/1', 'elderly (≥ 70 years old) versus younger patients enrolled in a phase III advanced non-small-cell lung cancer (NSCLC) trial']","['weekly nab®-paclitaxel', 'carboplatin', 'carboplatin AUC6', 'nab-paclitaxel (Abraxane) 100 mg/m(2) weekly (nab-P/C) or solvent-based paclitaxel (Taxol']","['ORR and PFS', 'overall response rate (ORR', 'Adverse events', 'neuropathy', 'overall survival (OS', 'neutropenia', 'PFS', 'safety and efficacy', 'arthralgia', 'ORR', 'anemia', 'Safety and efficacy', 'OS', 'progression-free survival (PFS']","[{'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0037638', 'cui_str': 'Solvents'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678133', 'cui_str': 'Taxol'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003862', 'cui_str': 'Joint Pain'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1052.0,0.146271,"Adverse events were similar in both age groups, with less neutropenia (P = 0.015), neuropathy (P = 0.001), and arthralgia (P = 0.029), and increased anemia (P = 0.007) with nab-P/C versus sb-P/C.
CONCLUSIONS


","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Socinski', 'Affiliation': 'University of Pittsburgh Medical Center, Division of Hematology/Oncology, Pittsburgh. Electronic address: socinskima@upmc.edu.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Langer', 'Affiliation': 'University of Pennsylvania, Fox Chase Cancer Center, Philadelphia, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Kinki University Faculty of Medicine, Department of Medical Oncology,Osaka-Sayama, Japan.'}, {'ForeName': 'J K', 'Initials': 'JK', 'LastName': 'Hon', 'Affiliation': 'Clearview Cancer Institute, Huntsville, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Hirsh', 'Affiliation': 'McGill University, Department of Oncology, Montreal, Quebec, Canada.'}, {'ForeName': 'S R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Cancer Center of Kansas, Wichita.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Page', 'Affiliation': 'The Center for Cancer and Blood Disorders, Fort Worth.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Orsini', 'Affiliation': 'Essex Oncology of North Jerse, PA, Belleville.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Celgene, Clinical Research and Development, Summit, USA.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Renschler', 'Affiliation': 'Celgene, Clinical Research and Development, Summit, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds461']
3121,32028795,Patient experience of preheated and room temperature skin disinfection prior to cardiac device implantation: A randomised controlled trial.,"BACKGROUND


Clinically, patients often comment on the coolness of the skin disinfectant. However, scarce evidence is available regarding patients' experience during intraoperative skin disinfection.
AIMS


The aim of this study was to describe and compare intraoperative patient experiences with preheated and room temperature skin disinfectant.
METHOD


This randomised controlled trial included 220 patients undergoing cardiac device implantation. Patients allocated to preheated (36°C) or room temperature (20°C) chlorhexidine in 70% ethanol verbally answered an open-ended question regarding their experience with the skin disinfection. Results were assessed using a qualitative approach with comparative quantification.
RESULTS


The analysis resulted in nine categories describing the patients' experiences with preheated and room temperature skin disinfection. Most of the patients described the skin disinfection process as a negative experience, which consisted of six categories: cold, smell, change in temperature, unpleasant, wet and painful. In addition, two neutral categories of response (nothing in particular and neither pleasant nor unpleasant) and one positive response (pleasant) emerged through the analysis. Preheated skin disinfection yielded significantly fewer negative experiences in the category cold (85% vs. 15%,  P <0.0001) and significantly more positive experiences (66% vs. 34%,  P <0.002). Neutral categories (neither pleasant nor unpleasant 65% vs. 35%,  P =0.01, nothing in particular 74% vs. 26%,  P <0.001) dominated after preheated skin disinfection.
CONCLUSION


The use of preheated skin disinfection promotes a positive patient experience with skin disinfection.
TRIAL REGISTRATION


ClinicalTrials.gov registration number NCT02260479 (https://clinicaltrials.gov/ct2/results?cond=preheated+skin+disinfection).",2020,"Neutral categories (neither pleasant nor unpleasant 65% vs. 35%,  P =0.01, nothing in particular 74% vs. 26%,  P <0.001) dominated after preheated skin disinfection.
","['patients often comment on the coolness of the skin disinfectant', '220 patients undergoing cardiac device implantation']","['preheated and room temperature skin disinfection prior to cardiac device implantation', 'preheated and room temperature skin disinfectant', 'room temperature (20°C) chlorhexidine in 70% ethanol verbally answered an open-ended question regarding their experience with the skin disinfection', 'preheated skin disinfection']",['positive experiences'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282411', 'cui_str': 'Commentary'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0012682', 'cui_str': 'Disinfectants'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}]","[{'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C1698034', 'cui_str': 'Skin disinfection'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0012682', 'cui_str': 'Disinfectants'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0202304', 'cui_str': 'Alcohol measurement (procedure)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",220.0,0.125965,"Neutral categories (neither pleasant nor unpleasant 65% vs. 35%,  P =0.01, nothing in particular 74% vs. 26%,  P <0.001) dominated after preheated skin disinfection.
","[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Wistrand', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, Sweden.'}, {'ForeName': 'Ulrica', 'Initials': 'U', 'LastName': 'Nilsson', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Karolinska Institute, Sweden.'}, {'ForeName': 'Ann-Sofie', 'Initials': 'AS', 'LastName': 'Sundqvist', 'Affiliation': 'University Health Care Research Center, Faculty of Medicine and Health, Örebro University, Sweden.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515119900062']
3122,32031643,Smartphones vs Wearable Devices for Remotely Monitoring Physical Activity After Hospital Discharge: A Secondary Analysis of a Randomized Clinical Trial.,,2020,,['After Hospital Discharge'],['Smartphones vs Wearable Devices for Remotely Monitoring Physical Activity'],[],"[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C4505348', 'cui_str': 'Wearable Electronic Devices'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],,0.291431,,"[{'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Polsky', 'Affiliation': 'Leonard Davis Institute for Health Economics, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Edward H', 'Initials': 'EH', 'LastName': 'Kennedy', 'Affiliation': 'Department of Statistics and Data Science, Carnegie Mellon University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'Wharton School, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Chalanda N', 'Initials': 'CN', 'LastName': 'Evans', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Charles A L', 'Initials': 'CAL', 'LastName': 'Rareshide', 'Affiliation': 'Penn Medicine Nudge Unit, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.20677']
3123,32026250,"Addressing Intimate Partner Violence and Power in Intimate Relationships in HIV Testing Services in Nairobi, Kenya.","Intimate partner violence (IPV) undermines women's uptake of HIV services and violates their human rights. In a two-arm randomized controlled trial we evaluated a short intervention that went a step beyond IPV screening to discuss violence and power with women receiving HIV testing services during antenatal care (ANC). The intervention included training and support for HIV counselors, a take-home card for clients, and an on-site IPV counselor. One third (35%) of women (N = 688) reported experiencing IPV in the past year; 6% were living with HIV. Among women experiencing IPV, program participants were more likely to disclose violence to their counselor than women receiving standard care (32% vs. 7%, p < 0.001). At second ANC visit, intervention group women were significantly more likely to report that talking with their counselor made a positive difference (aOR 2.9; 95% CI 1.8, 4.4; p < 0.001) and felt more confident in how they deserved to be treated (aOR 2.7; 95% CI 1.7, 4.4; p < 0.001). Exploratory analyses of intent to use ARVs to prevent mother-to-child transmission and actions to address violence were also encouraging.",2020,"At second ANC visit, intervention group women were significantly more likely to report that talking with their counselor made a positive difference (aOR 2.9; 95% CI 1.8, 4.4; p < 0.001) and felt more confident in how they deserved to be treated (aOR 2.7; 95% CI 1.7, 4.4; p < 0.001).","[""Intimate partner violence (IPV) undermines women's uptake of HIV services and violates their human rights"", 'HIV Testing Services in Nairobi, Kenya', 'violence and power with women receiving HIV testing services during antenatal care (ANC']","['training and support for HIV counselors, a take-home card for clients, and an on-site IPV counselor']",['experiencing IPV'],"[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0020138', 'cui_str': 'Human Rights'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}]","[{'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}]",,0.0526836,"At second ANC visit, intervention group women were significantly more likely to report that talking with their counselor made a positive difference (aOR 2.9; 95% CI 1.8, 4.4; p < 0.001) and felt more confident in how they deserved to be treated (aOR 2.7; 95% CI 1.7, 4.4; p < 0.001).","[{'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Haberland', 'Affiliation': 'Population Council, One Dag Hammarskjold Plaza, New York, NY, 10017, USA. nhaberland@popcouncil.org.'}, {'ForeName': 'Charity', 'Initials': 'C', 'LastName': 'Ndwiga', 'Affiliation': 'Population Council, Nairobi, Kenya.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'McCarthy', 'Affiliation': 'Population Council, One Dag Hammarskjold Plaza, New York, NY, 10017, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Pulerwitz', 'Affiliation': 'Population Council, Washington, DC, USA.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Kosgei', 'Affiliation': 'Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': ""Mak'anyengo"", 'Affiliation': 'Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Peltz', 'Affiliation': 'Office of HIV/AIDS, United States Agency for International Development, Washington, DC, USA.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Wong', 'Affiliation': 'Office of HIV/AIDS, United States Agency for International Development, Washington, DC, USA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Kalibala', 'Affiliation': 'Population Council, Washington, DC, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02801-9']
3124,23559149,FOLFOX4 plus cetuximab administered weekly or every second week in the first-line treatment of patients with KRAS wild-type metastatic colorectal cancer: a randomized phase II CECOG study.,"BACKGROUND


This randomized phase II study investigated first-line chemotherapy plus cetuximab administered every second week in KRAS wild-type metastatic colorectal cancer.
PATIENTS AND METHODS


Patients received FOLFOX4 plus either standard weekly cetuximab (arm 1) or cetuximab (500 mg/m(2)) every second week (arm 2), until disease progression or unacceptable toxicity. Primary end point was the objective response rate (ORR). Progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and safety were also investigated. The study was not powered to establish non-inferiority, but aimed at the estimation of treatment differences.
RESULTS


Of 152 randomized eligible patients, 75 were treated in arm 1 and 77 in arm 2; ORRs [53% versus 62%, odds ratio 1.40, 95% confidence interval (CI) 0.74-2.66], PFS [median 9.5 versus 9.2 months, hazard ratio (HR) 0.92, 95% CI 0.63-1.34], OS (median 25.8 versus 23.0 months, HR 0.86, 95% CI 0.56-1.30) and DCR (87%) were comparable. HRs adjusted for baseline factors were 1.01 and 0.99 for PFS and OS, respectively. Frequencies of grade 3/4 adverse events in arms 1 versus 2 were similar: most common were neutropenia (28% versus 34%) and rash (15% versus 17%).
CONCLUSIONS


Activity and safety of FOLFOX4 plus either cetuximab administered weekly or every second week were similar.",2013,"Frequencies of grade 3/4 adverse events in arms 1 versus 2 were similar: most common were neutropenia (28% versus 34%) and rash (15% versus 17%).
",['patients with KRAS wild-type metastatic colorectal cancer'],"['FOLFOX4 plus either standard weekly cetuximab (arm 1) or cetuximab (500 mg/m(2', 'FOLFOX4 plus cetuximab', 'chemotherapy plus cetuximab', 'FOLFOX4 plus either cetuximab']","['Frequencies of grade 3/4 adverse events', 'Progression-free survival (PFS), overall survival (OS), disease control rate (DCR) and safety', 'objective response rate (ORR', 'neutropenia', 'PFS', 'rash', 'OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}]",,0.0916167,"Frequencies of grade 3/4 adverse events in arms 1 versus 2 were similar: most common were neutropenia (28% versus 34%) and rash (15% versus 17%).
","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Brodowicz', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Vienna; Comprehensive Cancer Centre, Vienna, Austria.'}, {'ForeName': 'T E', 'Initials': 'TE', 'LastName': 'Ciuleanu', 'Affiliation': 'Institutul Oncologic, Cluj Napoca, Romania.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Radosavljevic', 'Affiliation': 'Institute for Oncology and Radiology, Belgrade, Serbia.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Shacham-Shmueli', 'Affiliation': 'Division of Oncology, Tel Aviv Souraski Medical Center, Tel Aviv, Israel.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Vrbanec', 'Affiliation': 'Department of Oncology, University Hospital Zagreb/Rebro, Zagreb, Croatia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Plate', 'Affiliation': 'The Latvian Center of Oncology, Riga, Latvia.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Mrsic-Krmpotic', 'Affiliation': 'Department of Medical Oncology, University Hospital for Tumors, Zagreb, Croatia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dank', 'Affiliation': 'Radiology Clinic, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Purkalne', 'Affiliation': 'P Stradins University Hospital, Riga, Latvia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Messinger', 'Affiliation': 'Biometrics, IST GmbH, Mannheim, Germany.'}, {'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Zielinski', 'Affiliation': 'Department of Medicine I, Medical University of Vienna, Vienna; Comprehensive Cancer Centre, Vienna, Austria. Electronic address: christoph.zielinski@meduniwien.ac.at.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt116']
3125,31318997,Risk factors and nomogram for diabetes mellitus in idiopathic chronic pancreatitis.,"BACKGROUND AND AIM


Diabetes mellitus (DM) is a common complication of idiopathic chronic pancreatitis (ICP), which impairs the quality of life for patients. This study aimed to identify risk factors and develop nomogram for DM in ICP to help early diagnosis.
METHODS


Idiopathic chronic pancreatitis patients admitted to our center from January 2000 to December 2013 were included. Cumulative rates of DM were calculated by Kaplan-Meier method. Patients were randomly assigned, in a 2:1 ratio, to the training and validation cohort. Based on training cohort, risk factors for DM were identified through Cox proportional hazards regression model, and nomogram was developed. Internal and external validations were performed based on the training and validation cohort, respectively.
RESULTS


Totally, 1633 patients with ICP were finally enrolled. The median follow-up duration was 9.8 years. DM was found in 26.3% (430/1633) of patients after the onset of CP. Adult at onset of ICP, biliary stricture at/before diagnosis of CP, steatorrhea at/before diagnosis of CP, and complex pathologic changes in main pancreatic duct were identified risk factors for DM development. The nomogram achieved good concordance indexes in the training and validation cohorts, respectively, with well-fitted calibration curves.
CONCLUSIONS


Risk factors were identified, and nomogram was developed to determine the risk of DM in ICP patients. Patients with one or more of the risk factors including adult at onset of ICP, biliary stricture at/before diagnosis of CP, steatorrhea at/before diagnosis of CP, and complex pathologic changes in main pancreatic duct have higher incidence of DM.",2020,"The nomogram achieved good concordance indexes in the training and validation cohorts, respectively, with well-fitted calibration curves.
","['idiopathic chronic pancreatitis', 'Idiopathic chronic pancreatitis patients admitted to our center from January 2000 to December 2013 were included', '1633 patients with ICP were finally enrolled']",[],"['DM', 'Cumulative rates of DM']","[{'cui': 'C0341471', 'cui_str': 'Idiopathic chronic pancreatitis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],[],1633.0,0.0336616,"The nomogram achieved good concordance indexes in the training and validation cohorts, respectively, with well-fitted calibration curves.
","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Hong-Lei', 'Initials': 'HL', 'LastName': 'Guo', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.'}, {'ForeName': 'Teng', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Huai-Yu', 'Initials': 'HY', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jia-Yi', 'Initials': 'JY', 'LastName': 'Ma', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ling-Ling', 'Initials': 'LL', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Han', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Jin-Huan', 'Initials': 'JH', 'LastName': 'Lin', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ya-Wei', 'Initials': 'YW', 'LastName': 'Bi', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xin', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Xiang-Peng', 'Initials': 'XP', 'LastName': 'Zeng', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Xie', 'Affiliation': 'Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing, China.'}, {'ForeName': 'Zhuan', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Cong', 'Affiliation': 'Department of General Surgery, Renji Hospital, Shanghai Jiaotong University, Shanghai, China.'}, {'ForeName': 'Li-Sheng', 'Initials': 'LS', 'LastName': 'Wang', 'Affiliation': ""Department of Gastroenterology, The Second Clinical Medical College (Shenzhen People's Hospital), Jinan University, Guangdong, China.""}, {'ForeName': 'Zheng-Lei', 'Initials': 'ZL', 'LastName': 'Xu', 'Affiliation': ""Department of Gastroenterology, The Second Clinical Medical College (Shenzhen People's Hospital), Jinan University, Guangdong, China.""}, {'ForeName': 'Zhao-Shen', 'Initials': 'ZS', 'LastName': 'Li', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': 'Liang-Hao', 'Initials': 'LH', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology, Gongli Hospital, The Second Military Medical University, Shanghai, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of gastroenterology and hepatology,['10.1111/jgh.14785']
3126,31207178,Bioequivalence of Ertugliflozin/Metformin Fixed-Dose Combination Tablets and Coadministration of Respective Strengths of Individual Components.,"A fixed-dose combination (FDC) of ertugliflozin, a selective sodium-glucose cotransporter 2 inhibitor, and immediate-release metformin is approved for the treatment of type 2 diabetes mellitus in the United States and European Union. Four open-label, randomized, 2-period, single-dose, crossover studies were conducted under fasted conditions in healthy subjects to demonstrate bioequivalence of the ertugliflozin/metformin FDC tablets and coadministration of the individual components at respective strengths. In each study, 32 or 34 subjects received an ertugliflozin/metformin FDC tablet (2.5 mg/500 mg, 7.5 mg/850 mg, or 7.5 mg/1000 mg) and the respective doses of individual components (ertugliflozin with US- or EU-sourced metformin [Glucophage]). Plasma samples for ertugliflozin and metformin concentrations were collected for 72 hours in each period. For both ertugliflozin and metformin, the 90% confidence intervals for the adjusted geometric mean ratio (FDC : coadministration) for area under the plasma concentration-time profile from time zero extrapolated to infinity and maximum observed plasma concentration were within acceptance criteria for bioequivalence. The majority of adverse events were mild in intensity. The studies demonstrated that each strength of FDC tablet is bioequivalent to respective doses of coadministered individual components, supporting that safety and efficacy can be bridged to the individual components used in phase 3 studies evaluating ertugliflozin in combination with metformin.",2020,"For both ertugliflozin and metformin, the 90% confidence intervals for the adjusted geometric mean ratio (FDC : coadministration) for area under the plasma concentration-time profile from time zero extrapolated to infinity and maximum observed plasma concentration were within acceptance criteria for bioequivalence.","['type 2 diabetes mellitus in the United States and European Union', 'healthy subjects']","['ertugliflozin/metformin FDC tablet', 'ertugliflozin/metformin FDC tablets', 'metformin', 'ertugliflozin, a selective sodium-glucose cotransporter 2 inhibitor, and immediate-release metformin', 'individual components (ertugliflozin with US- or EU-sourced metformin [Glucophage', 'ertugliflozin and metformin', 'Ertugliflozin/Metformin']",['Plasma samples for ertugliflozin and metformin concentrations'],"[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0015179', 'cui_str': 'European Community'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4535599', 'cui_str': 'ertugliflozin / Metformin'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0591573', 'cui_str': 'Glucophage'}]","[{'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0250123,"For both ertugliflozin and metformin, the 90% confidence intervals for the adjusted geometric mean ratio (FDC : coadministration) for area under the plasma concentration-time profile from time zero extrapolated to infinity and maximum observed plasma concentration were within acceptance criteria for bioequivalence.","[{'ForeName': 'Vikas Kumar', 'Initials': 'VK', 'LastName': 'Dawra', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'Pfizer, Shanghai, China.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Pelletier', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Haihong', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Almasa', 'Initials': 'A', 'LastName': 'Bass', 'Affiliation': 'Pfizer Inc., Durham, NC, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Krishna', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Sahasrabudhe', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.703']
3127,32030525,"A Pilot Test of Game Changers, a Social Network Intervention to Empower People with HIV to be Prevention Advocates in Uganda.","We conducted a pilot randomized controlled trial of Game Changers, a 6-session group intervention that empowers people with HIV to be HIV prevention advocates in their social networks. Ninety-nine people with HIV (51 intervention, 48 wait-list control) and 58 of their social network members (alters) completed baseline and 5- and 8-month post-baseline assessments. Results indicated high acceptability, demonstrated by participants' and facilitators' positive attitudes qualitatively and favorable ratings of intervention sessions quantitatively, and high feasibility (76% attended all intervention sessions). Intention-to-treat analyses indicated significantly increased HIV prevention advocacy among HIV-positive participants and alters [b (SE) = 0.4 (0.2), p = .017; b (SE) = 0.4 (0.2), p = .035]; reduced internalized HIV stigma [b (SE) =  - 0.3 (0.1), p = .012], increased HIV-serostatus disclosure [b (SE) = 0.1 (0.1), p = .051], and increased social network density among HIV-positive participants [b (SE) = 0.1 (0.03), p = .004]; and marginally reduced condomless sex among alters [OR (95% CI) = 0.3 (0.1-1.2), p = .08]. Positioning people with HIV as central to prevention has the potential to reduce stigma and improve prevention outcomes throughout social networks.",2020,"Intention-to-treat analyses indicated significantly increased HIV prevention advocacy among HIV-positive participants and alters [b (SE) = 0.4 (0.2), p = .017; b (SE) = 0.4 (0.2), p = .035]; reduced internalized HIV stigma [b (SE) =  - 0.3 (0.1), p = .012], increased HIV-serostatus disclosure [b (SE) = 0.1 (0.1), p = .051], and increased social network density among HIV-positive participants [b (SE) = 0.1 (0.03), p = .004]; and marginally reduced condomless sex among alters [OR (95% CI) = 0.3 (0.1-1.2), p = .08].","['Ninety-nine people with HIV (51 intervention, 48 wait-list control) and 58 of their social network members (alters) completed baseline and 5- and 8-month post-baseline assessments', 'empowers people with HIV to be HIV prevention advocates in their social networks', 'Empower People with HIV to be Prevention Advocates in Uganda']","['6-session group intervention', 'Game Changers, a Social Network Intervention']","['HIV-serostatus disclosure', 'HIV prevention advocacy', 'internalized HIV stigma', 'social network density']","[{'cui': 'C3828813', 'cui_str': 'Ninety-nine'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0150446', 'cui_str': 'Advocacy (regime/therapy)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",99.0,0.0801244,"Intention-to-treat analyses indicated significantly increased HIV prevention advocacy among HIV-positive participants and alters [b (SE) = 0.4 (0.2), p = .017; b (SE) = 0.4 (0.2), p = .035]; reduced internalized HIV stigma [b (SE) =  - 0.3 (0.1), p = .012], increased HIV-serostatus disclosure [b (SE) = 0.1 (0.1), p = .051], and increased social network density among HIV-positive participants [b (SE) = 0.1 (0.03), p = .004]; and marginally reduced condomless sex among alters [OR (95% CI) = 0.3 (0.1-1.2), p = .08].","[{'ForeName': 'Laura M', 'Initials': 'LM', 'LastName': 'Bogart', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA. lbogart@rand.org.'}, {'ForeName': 'Joseph K B', 'Initials': 'JKB', 'LastName': 'Matovu', 'Affiliation': 'Makerere University School of Public Health, Kampala, Uganda.'}, {'ForeName': 'Glenn J', 'Initials': 'GJ', 'LastName': 'Wagner', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Harold D', 'Initials': 'HD', 'LastName': 'Green', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Erik D', 'Initials': 'ED', 'LastName': 'Storholm', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Klein', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Marsh', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'MacCarthy', 'Affiliation': 'RAND Corporation, 1776 Main Street, P.O. Box 2138, Santa Monica, CA, 90407-2138, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kambugu', 'Affiliation': 'Infectious Diseases Institute, Makerere University College of Health Sciences, Kampala, Uganda.'}]",AIDS and behavior,['10.1007/s10461-020-02806-4']
3128,31941864,Effects of Dietary Blueberry (Vaccinium ashei Reade) Leaves on Mildly Postprandial Hypertriglyceridemia.,"Prevention of postprandial hypertriglyceridemia is an important consideration for reducing the risk of developing cardiovascular disease. While blueberry fruits have been reported to ameliorate lipid metabolism in humans, there are only few research reports on the effects of blueberry leaves (BL). Here, we investigated the efficacy of BL on postprandial hyperlipidemia in subjects with high fasting triacylglycerol (TG) concentrations. Randomized, double-blind, cross-over design study was conducted. The subjects consumed a BL containing beverage or a placebo beverage before a fat-enriched test meal. Blood samples were collected prior to and 1, 2, 3, 4, and 5 hours after consuming the test beverage. The postprandial serum TG and remnant-like particle cholesterol (RLP-C) concentrations were significantly lower in the BL beverage compared with those in the placebo beverage. Additionally, BL was more effective in subjects with high fasting ghrelin with gastric emptying function. In current study, fasting ghrelin correlated with the increase in postprandial serum TG, suggesting that BL ameliorates hypertriglyceridemia through delayed gastric emptying. In conclusion, this pilot study suggests that BL may be useful as an early dietary therapy for treating postprandial hyperlipidemia.",2020,The postprandial serum TG and remnant-like particle cholesterol (RLP-C) concentrations were significantly lower in the BL beverage compared with those in the placebo beverage.,"['subjects with high fasting ghrelin with gastric emptying function', 'subjects with high fasting triacylglycerol (TG) concentrations']","['Dietary Blueberry (Vaccinium ashei Reade) Leaves', 'BL containing beverage or a placebo beverage before a fat-enriched test meal', 'BL']","['postprandial hyperlipidemia', 'postprandial serum TG and remnant-like particle cholesterol (RLP-C) concentrations', 'Mildly Postprandial Hypertriglyceridemia']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]","[{'cui': 'C0950037', 'cui_str': 'Blueberries'}, {'cui': 'C3938145', 'cui_str': 'Vaccinium virgatum'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0674390', 'cui_str': 'remnant-like particle cholesterol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}]",,0.102768,The postprandial serum TG and remnant-like particle cholesterol (RLP-C) concentrations were significantly lower in the BL beverage compared with those in the placebo beverage.,"[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Shoji', 'Affiliation': ""Department of Food Science, Faculty of Home Economics, Otsuma Women's University.""}, {'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Yamasaki', 'Affiliation': 'Department of Biochemistry and Applied Biosciences, Faculty of Agriculture, University of Miyazaki.'}, {'ForeName': 'Hisato', 'Initials': 'H', 'LastName': 'Kunitake', 'Affiliation': 'Department of Biochemistry and Applied Biosciences, Faculty of Agriculture, University of Miyazaki.'}]",Journal of oleo science,['10.5650/jos.ess19201']
3129,23104724,"A randomized, double-blind, multicenter, phase 2 study of a human monoclonal antibody to human αν integrins (intetumumab) in combination with docetaxel and prednisone for the first-line treatment of patients with metastatic castration-resistant prostate cancer.","BACKGROUND


Intetumumab is a fully human mAb with antiangiogenic, antitumor properties which has shown potential therapeutic effect in castration-resistant prostate cancer (CRPC) patients.
PATIENTS AND METHODS


In a phase 2, randomized, double-blind, multicenter study, men with metastatic CRPC without prior systemic nonhormonal therapy were randomly assigned to 75-mg/m(2) docetaxel (Taxotere) and 5-mg prednisone plus placebo (N = 65) or 10-mg/kg intetumumab (N = 66) q3w. Placebo patients with progressive disease (PD) could cross over to 10-mg/kg intetumumab alone or with docetaxel. The primary end-point was progression-free survival (PFS). The secondary end-points included tumor response (complete response + partial response, CR + PR), prostate-specific antigen (PSA) response, and overall survival (OS).
RESULTS


All efficacy end-points favored placebo over intetumumab, including PFS (median 11.0 versus 7.6 months, P = 0.014), tumor response (20% versus 16%, P = 0.795), PSA response (68% versus 47%, P = 0.018), OS (median 20.6 versus 17.2 months, P = 0.163). Common all-grade adverse events (AEs) with placebo and intetumumab were alopecia (43% versus 26%); diarrhea, leukopenia (both 34% versus 27%); neutropenia (35% versus 23%). Grade ≥ 3 leukopenia (28% versus 17%) and neutropenia (26% versus 18%) occurred more often with placebo than with intetumumab. Intetumumab serum concentrations increased with repeated dosing and did not reach steady-state. Greater decreases in N-telopeptide of type I collagen (NTx), C-telopeptide (CTx) and CTCs occurred with intetumumab than with placebo.
CONCLUSION


The addition of intetumumab to docetaxel resulted in shorter PFS without additional toxicity among CRPC patients.",2013,Grade ≥ 3 leukopenia (28% versus 17%) and neutropenia (26% versus 18%) occurred more often with placebo than with intetumumab.,"['men with metastatic CRPC without prior systemic nonhormonal therapy', 'castration-resistant prostate cancer (CRPC) patients', 'CRPC patients', 'patients with metastatic castration-resistant prostate cancer', 'patients with progressive disease (PD']","['placebo', 'Placebo', 'human monoclonal antibody to human αν integrins (intetumumab) in combination with docetaxel and prednisone', 'docetaxel (Taxotere) and 5-mg prednisone plus placebo (N = 65) or 10-mg/kg intetumumab', 'docetaxel']","['Intetumumab serum concentrations', 'PSA response', 'diarrhea, leukopenia', 'N-telopeptide of type', 'tumor response (complete response + partial response, CR + PR), prostate-specific antigen (PSA) response, and overall survival (OS', 'alopecia', 'neutropenia', 'Grade ≥ 3 leukopenia', 'PFS', 'I collagen (NTx), C-telopeptide (CTx) and CTCs', 'OS', 'tumor response', 'progression-free survival (PFS']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C0021701', 'cui_str': 'Integrins'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1881068', 'cui_str': 'intetumumab'}]","[{'cui': 'C1881068', 'cui_str': 'intetumumab'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C1868706', 'cui_str': 'N-telopeptide'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.498978,Grade ≥ 3 leukopenia (28% versus 17%) and neutropenia (26% versus 18%) occurred more often with placebo than with intetumumab.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Heidenreich', 'Affiliation': 'Department of Urology, University Hospital of Cologne, Cologne. Electronic address: aheidenreich@ukaachen.de.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Rawal', 'Affiliation': 'Department of Uro-Oncology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Szkarlat', 'Affiliation': 'Urological Ward, Koscierzyna Hospital, Koscierzyna, Poland.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bogdanova', 'Affiliation': 'P. A. Hertzen Oncology Research Institute, Moscow, Russia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dirix', 'Affiliation': 'Department of Cancer Research, GZA Hospitals St. Augustine Campus, Wilrijk, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stenzl', 'Affiliation': 'Department of Urology, Eberhard-Karls University, Tübingen.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Welslau', 'Affiliation': 'Hematology/Oncology, Studienzentrum, Aschaffenburg, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Biostatistics, Janssen Research & Development, Spring House.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dawkins', 'Affiliation': 'Hematology & Oncology General, Janssen Research & Development, Raritan, USA.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'de Boer', 'Affiliation': 'Oncology, Janssen Biologics Europe, Leiden, The Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Schrijvers', 'Affiliation': 'Medical Oncology, Hospital Network Antwerp (ZNA)-Middelheim, Antwerp, Belgium.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds505']
3130,23510984,"A randomized, placebo-controlled phase 2 study of ganitumab or conatumumab in combination with FOLFIRI for second-line treatment of mutant KRAS metastatic colorectal cancer.","BACKGROUND


Targeted agents presently available for mutant KRAS metastatic colorectal cancer (mCRC) are bevacizumab and aflibercept. We evaluated the efficacy and safety of conatumumab (an agonistic monoclonal antibody against human death receptor 5) and ganitumab (a monoclonal antibody against the type 1 insulin-like growth factor receptor) combined with standard FOLFIRI chemotherapy as a second-line treatment in patients with mutant KRAS mCRC.
PATIENTS AND METHODS


Patients with mutant KRAS metastatic adenocarcinoma of the colon or rectum refractory to fluoropyrimidine- and oxaliplatin-based chemotherapy were randomized 1 : 1 : 1 to receive intravenous FOLFIRI plus conatumumab 10 mg/kg (Arm A), ganitumab 12 mg/kg (Arm B), or placebo (Arm C) Q2W. The primary end point was progression-free survival (PFS).
RESULTS


In total, 155 patients were randomized. Median PFS in Arms A, B, and C was 6.5 months (HR, 0.69; P = 0.147), 4.5 months (HR, 1.01; P = 0.998), and 4.6 months, respectively; median overall survival was 12.3 months (HR, 0.89; P = 0.650), 12.4 months (HR, 1.27; P = 0.357), and 12.0 months; and objective response rate was 14%, 8%, and 2%. The most common grade ≥3 adverse events in Arms A/B/C included neutropenia (30%/25%/18%) and diarrhea (18%/2%/10%).
CONCLUSIONS


Conatumumab, but not ganitumab, plus FOLFIRI was associated with a trend toward improved PFS. Both combinations had acceptable toxicity.",2013,"Median PFS in Arms A, B, and C was 6.5 months (HR, 0.69; P = 0.147), 4.5 months (HR, 1.01; P = 0.998), and 4.6 months, respectively; median overall survival was 12.3 months (HR, 0.89; P = 0.650), 12.4 months (HR, 1.27; P = 0.357), and 12.0 months; and objective response rate was 14%, 8%, and 2%.","['mutant KRAS metastatic colorectal cancer (mCRC', 'mutant KRAS metastatic colorectal cancer', '155 patients were randomized', 'Patients with mutant KRAS metastatic adenocarcinoma of the colon or rectum refractory to', 'patients with mutant KRAS mCRC']","['conatumumab', 'intravenous FOLFIRI plus conatumumab', 'placebo', 'bevacizumab and aflibercept', 'ganitumab or conatumumab', 'standard FOLFIRI chemotherapy', 'fluoropyrimidine- and oxaliplatin-based chemotherapy', 'ganitumab 12 mg/kg (Arm B), or placebo (Arm C) Q2W']","['median overall survival', 'objective response rate', 'efficacy and safety', 'diarrhea', 'neutropenia', 'Median PFS', 'PFS', 'acceptable toxicity', 'progression-free survival (PFS']","[{'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0334277', 'cui_str': 'Adenocarcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0034896', 'cui_str': 'Rectum'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]","[{'cui': 'C2346822', 'cui_str': 'conatumumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C2980089'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",155.0,0.449519,"Median PFS in Arms A, B, and C was 6.5 months (HR, 0.69; P = 0.147), 4.5 months (HR, 1.01; P = 0.998), and 4.6 months, respectively; median overall survival was 12.3 months (HR, 0.89; P = 0.650), 12.4 months (HR, 1.27; P = 0.357), and 12.0 months; and objective response rate was 14%, 8%, and 2%.","[{'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Cohn', 'Affiliation': 'Rocky Mountain Cancer Center, Denver, USA. Electronic address: allen.cohn@usoncology.com.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Medical Oncology Department, Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron University Hospital, Universitat Autònoma de Barcelona, Barcelona.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Maurel', 'Affiliation': 'Medical Oncology Department, Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Nowara', 'Affiliation': 'Maria Skodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice, Poland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sastre', 'Affiliation': 'Hospital Clinico San Carlos, Servicio de Oncologíca Medíca, Madrid, and Instituto Carlos III, Spanish Ministry of Science and Innovation, Madrid, Spain.'}, {'ForeName': 'B Y S', 'Initials': 'BYS', 'LastName': 'Chuah', 'Affiliation': 'Department of Internal Medicine, National University Hospital, Singapore, Singapore.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Kopp', 'Affiliation': 'Samara Regional Oncology Dispensary, Samara.'}, {'ForeName': 'D D', 'Initials': 'DD', 'LastName': 'Sakaeva', 'Affiliation': 'Clinical Oncology Dispensary of the Republic of Bashkortostan, Ufa, Russia.'}, {'ForeName': 'E P', 'Initials': 'EP', 'LastName': 'Mitchell', 'Affiliation': 'Department of Medical Oncology, Thomas Jefferson University Hospital, Philadelphia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dubey', 'Affiliation': 'Amgen Inc., South San Francisco.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Amgen Inc., South San Francisco.'}, {'ForeName': 'Y-J', 'Initials': 'YJ', 'LastName': 'Hei', 'Affiliation': 'Amgen Inc., Thousand Oaks.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Galimi', 'Affiliation': 'Amgen Inc., Thousand Oaks.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'McCaffery', 'Affiliation': 'Amgen Inc., Thousand Oaks.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Amgen Inc., Seattle, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Loberg', 'Affiliation': 'Amgen Inc., Thousand Oaks.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cottrell', 'Affiliation': 'Amgen Inc., Seattle, USA.'}, {'ForeName': 'S-P', 'Initials': 'SP', 'LastName': 'Choo', 'Affiliation': 'Medical Oncology, National Cancer Centre Singapore, Singapore.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt057']
3131,31172685,"First-in-Human Study of AG10, a Novel, Oral, Specific, Selective, and Potent Transthyretin Stabilizer for the Treatment of Transthyretin Amyloidosis: A Phase 1 Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Adult Volunteers.","AG10 is a novel, potent, and selective oral transthyretin (TTR) stabilizer being developed to treat TTR amyloidosis (ATTR). This randomized, double-blind, placebo-controlled study evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics (ex vivo stabilization) of orally administered AG10 in healthy adult volunteers. Both mutant and wild-type ATTR are underdiagnosed diseases with limited therapeutic options. As TTR amyloidogenesis is initiated by dissociation of TTR tetramers destabilized due to inherited mutations or aging, AG10 is designed to treat the disease at its source. Four single and three multiple ascending dose levels of AG10 or matching placebo were orally administered. Safety and tolerability were assessed by vital signs, electrocardiogram, adverse events, and clinical laboratory tests. Pharmacokinetics were measured using a validated bioanalytical assay. Pharmacodynamics were assessed via three pharmacodynamic assays of TTR stabilization. AG10 was uniformly well tolerated, and no safety signals of clinical concern were observed. Pharmacokinetic observations included time to maximum concentration <1 hour, dose-dependent maximum concentration and area under the plasma concentration-time curve, low intersubject variability, and half-life ∼25 hr. Complete (>90%) stabilization of TTR was observed across the entire dosing interval at steady state on the highest dose tested. Serum TTR levels, an in vivo reflection of TTR stabilization by AG10, increased from baseline following 12 days of dosing. AG10 appears to be safe and well tolerated in healthy adult volunteers and can completely stabilize TTR across the dosing interval, establishing clinical proof of concept. Based on these data, AG10 has the potential to be a safe and effective treatment for patients with either mutant or wild-type ATTR.",2020,"AG10 appears to be safe and well tolerated in healthy adult volunteers and can completely stabilize TTR across the dosing interval, establishing clinical proof of concept.","['Healthy Adult Volunteers', 'patients with either mutant or wild-type ATTR', 'healthy adult volunteers']","['placebo', 'AG10 or matching placebo']","['safe and well tolerated', 'stabilization of TTR', 'safety, tolerability, pharmacokinetics, and pharmacodynamics (ex vivo stabilization', 'time to maximum concentration <1\xa0hour, dose-dependent maximum concentration and area under the plasma concentration-time curve, low intersubject variability, and half-life', 'Serum TTR levels', 'vital signs, electrocardiogram, adverse events, and clinical laboratory tests', 'Safety and tolerability']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0518766'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4505474', 'cui_str': 'Clinical Laboratory Tests'}]",,0.0626475,"AG10 appears to be safe and well tolerated in healthy adult volunteers and can completely stabilize TTR across the dosing interval, establishing clinical proof of concept.","[{'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Fox', 'Affiliation': 'Eidos Therapeutics, Inc., San Francisco, CA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Hellawell', 'Affiliation': 'Eidos Therapeutics, Inc., San Francisco, CA, USA.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Eidos Therapeutics, Inc., San Francisco, CA, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': ""O'Reilly"", 'Affiliation': 'Celerion, Inc., Tempe, AZ, USA.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Lumpkin', 'Affiliation': 'Eidos Therapeutics, Inc., San Francisco, CA, USA.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Jernelius', 'Affiliation': 'Eidos Therapeutics, Inc., San Francisco, CA, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Gretler', 'Affiliation': 'Eidos Therapeutics, Inc., San Francisco, CA, USA.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Sinha', 'Affiliation': 'Eidos Therapeutics, Inc., San Francisco, CA, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.700']
3132,32043706,"Viscoelastic and chemical properties of dentine after different exposure times to sodium hypochlorite, ethylenediaminetetraacetic acid and calcium hydroxide.","This study aims to evaluate the viscoelastic and chemical properties of dentine after different durations of exposure to 5.25% NaOCl, 17% EDTA and Ca(OH) 2  solutions, and NaOCl in alternating combination with EDTA. Standard dentine bars were randomly assigned to: (i) formal-saline control-1; (ii) NaOCl; (iii) EDTA; (iv) NaOCl/EDTA; (v) formal-saline control-2; (vi) Ca(OH) 2  pH 12.6; and (vii) Ca(OH) 2  pH 9.8. Groups 1--4 underwent 10 min cycles of soaking and dynamic mechanical analysis up to 120 min. Groups 5-7 underwent similar tests at days 7, 14, 28 and 84. FTIR spectra of dentine discs exposed to the same regimens assessed surface chemistry. NaOCl or Ca(OH) 2  (pH 12.6) solutions reduced the organic (N-H[1], N-H[3], C=0) peak components of dentine. This study demonstrated that accumulative damage of dentine could be facilitated by alternated exposure to NaOCl and EDTA. Exposure of dentine to Ca(OH) 2  (pH12.6) for 7 days reduced viscous behaviour, inferring increased potential for fatigue failure.",2020,"Exposure of dentine to Ca(OH) 2  (pH12.6) for 7 days reduced viscous behaviour, inferring increased potential for fatigue failure.",[],"['sodium hypochlorite, ethylenediaminetetraacetic acid and calcium hydroxide', 'NaOCl in alternating combination with EDTA', 'formal-saline control-1; (ii) NaOCl; (iii) EDTA; (iv) NaOCl/EDTA; (v) formal-saline control-2; (vi) Ca(OH) 2']",['viscous behaviour'],[],"[{'cui': 'C0037518', 'cui_str': 'Sodium Hypochlorite'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0006701', 'cui_str': 'calcium hydroxide'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0529584', 'cui_str': 'isothiocyanatobenzyl-EDTA'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0470024,"Exposure of dentine to Ca(OH) 2  (pH12.6) for 7 days reduced viscous behaviour, inferring increased potential for fatigue failure.","[{'ForeName': 'Yuan-Ling', 'Initials': 'YL', 'LastName': 'Ng', 'Affiliation': 'Unit of Endodontology, Division of Restorative Dental Science, UCL Eastman Dental Institute, University College London, London, UK.'}, {'ForeName': 'Liam P', 'Initials': 'LP', 'LastName': 'Reddington', 'Affiliation': 'Unit of Endodontology, Division of Restorative Dental Science, UCL Eastman Dental Institute, University College London, London, UK.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Berman', 'Affiliation': 'Unit of Endodontology, Division of Restorative Dental Science, UCL Eastman Dental Institute, University College London, London, UK.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Knowles', 'Affiliation': 'Division of Biomaterials & Tissue Engineering, UCL Eastman Dental Institute, University College London, London, UK.'}, {'ForeName': 'Showan N', 'Initials': 'SN', 'LastName': 'Nazhat', 'Affiliation': 'Department of Mining and Materials Engineering, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Kishor', 'Initials': 'K', 'LastName': 'Gulabivala', 'Affiliation': 'Unit of Endodontology, Division of Restorative Dental Science, UCL Eastman Dental Institute, University College London, London, UK.'}]",Australian endodontic journal : the journal of the Australian Society of Endodontology Inc,['10.1111/aej.12397']
3133,32022363,Long-term quality of life and cost-effectiveness of treatment of partial thickness burns: A randomized controlled trial comparing enzyme alginogel vs silver sulfadiazine (FLAM study).,"The clinical effectiveness and scar quality of the randomized controlled trial comparing enzyme alginogel with silver sulfadiazine (SSD) for treatment of partial thickness burns were previously reported. Enzyme alginogel did not lead to faster wound healing (primary outcome) or less scar formation. In the current study, the health-related quality of life (HRQoL), costs, and cost-effectiveness of enzyme alginogel compared with SSD in the treatment of partial thickness burns were studied. HRQoL was evaluated using the Burn Specific Health Scale-Brief (BSHS-B) and the EQ-5D-5L questionnaire 1 week before discharge and at 3, 6, and 12 months postburn. Costs were studied from a societal perspective (health care and nonhealth-care costs) for a follow-up period of 1 year. A cost-effectiveness analysis was performed using cost-effectiveness acceptability curves and comparing differences in societal costs and Quality Adjusted Life Years (QALYs) at 1 year postburn. Forty-one patients were analyzed in the enzyme alginogel group and 48 patients in the SSD group. None of the domains of BSHS-B showed a statistically significant difference between the treatment groups. Also, no statistically significant difference in QALYs was found between enzyme alginogel and SSD (difference -0.03; 95% confidence interval [CI], -0.09 to 0.03; P = .30). From both the health care and the societal perspective, the difference in costs between enzyme alginogel and SSD was not statistically significant: the difference in health-care costs was €3210 (95% CI, €-1247 to €7667; P = .47) and in societal costs was €3377 (95% CI €-6229 to €12 982; P = .49). The nonsignificant differences in costs and quality-adjusted life-years in favor of SSD resulted in a low probability (<25%) that enzyme alginogel is cost-effective compared to SSD. In conclusion, there were no significant differences in quality of life between both treatment groups. Enzyme alginogel is unlikely to be cost-effective compared with SSD in the treatment of partial thickness burns.",2020,Enzyme alginogel did not lead to faster wound healing (primary outcome) or less scar formation.,"['partial thickness burns', 'Forty-one patients were analysed in the enzyme alginogel group and 48 patients in the SSD group']","['enzyme alginogel with silver sulfadiazine (SSD', 'enzyme alginogel versus silver sulfadiazine']","['healthcare costs', 'costs and quality-adjusted life-years', 'quality of life', 'Burn Specific Health Scale-Brief (BSHS-B) and the EQ-5D-5L questionnaire', 'wound healing', 'health-related quality of life (HRQoL), costs and cost-effectiveness', 'scar formation', 'QALYs', 'clinical effectiveness and scar quality', 'societal costs and Quality Adjusted Life Years (QALYs', 'cost-effectiveness acceptability curves']","[{'cui': 'C0443275', 'cui_str': 'Partial thickness (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0723179', 'cui_str': 'SSD'}]","[{'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0037134', 'cui_str': 'silver sulfadiazine'}, {'cui': 'C0723179', 'cui_str': 'SSD'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0034380'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0222045'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",41.0,0.0512654,Enzyme alginogel did not lead to faster wound healing (primary outcome) or less scar formation.,"[{'ForeName': 'Zjir M', 'Initials': 'ZM', 'LastName': 'Rashaan', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Pieta', 'Initials': 'P', 'LastName': 'Krijnen', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Kelly Aa', 'Initials': 'KA', 'LastName': 'Kwa', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Margriet E', 'Initials': 'ME', 'LastName': 'van Baar', 'Affiliation': 'Association of Dutch Burn Centres, Maasstad Hospital, Rotterdam, Netherlands.'}, {'ForeName': 'Roelf S', 'Initials': 'RS', 'LastName': 'Breederveld', 'Affiliation': 'Department of Surgery, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'M Elske', 'Initials': 'ME', 'LastName': 'van den Akker-van Marle', 'Affiliation': 'Department of Biomedical Data Sciences, Medical Decision Making, Leiden University Medical Centre, Leiden, Netherlands.'}]",Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society,['10.1111/wrr.12799']
3134,32040959,Addition of Maraviroc Versus Placebo to Standard Antiretroviral Therapy for Initial Treatment of Advanced HIV Infection: A Randomized Trial.,"Background


Patients diagnosed with advanced HIV infection have a poor prognosis despite initiation of combined antiretroviral therapy (c-ART).
Objective


To assess the benefit of adding maraviroc, an antiretroviral drug with immunologic effects, to standard c-ART for patients with advanced disease at HIV diagnosis.
Design


Randomized controlled trial. (ClinicalTrials.gov: NCT01348308).
Setting


Clinical sites in France (n = 25), Italy (n = 5), and Spain (n = 20).
Participants


416 HIV-positive, antiretroviral-naive adults with CD4 counts less than 0.200 × 109 cells/L and/or a previous AIDS-defining event (ADE).
Intervention


C-ART plus placebo or maraviroc (300 mg twice daily with dose modification) for 72 weeks.
Measurements


The primary end point was first occurrence of severe morbidity (new ADE, selected serious infections, serious non-ADE, immune reconstitution inflammatory syndrome, or death). Prespecified secondary outcomes included primary outcome components, biological and pharmacokinetic measures, and adverse events graded 2 or higher.
Results


409 randomly assigned participants (207 in the placebo group and 202 in the maraviroc group) who received more than 1 dose were included in the analysis. During 72 weeks of follow-up, incidence of severe morbidity was 11.1 per 100 person-years in the maraviroc group and 11.2 per 100 person-years in the placebo group (hazard ratio, 0.97 [95% CI, 0.57 to 1.67]). Incidence of adverse events graded 2 or higher was 36.1 versus 41.5 per 100 person-years (incidence rate ratio, 0.87 [CI, 0.65 to 1.15]).
Limitations


Sixty-four participants discontinued therapy during follow-up. The study was not designed to evaluate time-dependent outcomes or effect modification.
Conclusion


Addition of maraviroc to standard c-ART does not improve clinical outcomes of patients initiating therapy for advanced HIV infection.
Primary Funding Source


INSERM-ANRS (French National Agency for Research on AIDS).",2020,"Conclusion


Addition of maraviroc to standard c-ART does not improve clinical outcomes of patients initiating therapy for advanced HIV infection.
","['Participants\n\n\n416 HIV-positive, antiretroviral-naive adults with CD4 counts less than 0.200', 'patients initiating therapy for advanced HIV infection', '409 randomly assigned participants (207 in the placebo group and 202 in the maraviroc group) who received more than 1 dose were included in the analysis', 'Setting\n\n\nClinical sites in France (n\xa0= 25), Italy (n\xa0= 5), and Spain (n\xa0= 20', 'patients with advanced disease at HIV diagnosis', 'Advanced HIV Infection']","['Maraviroc Versus Placebo', 'placebo', 'placebo or maraviroc']","['Incidence of adverse events', 'biological and pharmacokinetic measures, and adverse events graded 2 or higher', 'incidence of severe morbidity', 'severe morbidity (new ADE, selected serious infections, serious non-ADE, immune reconstitution inflammatory syndrome, or death']","[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0599685', 'cui_str': 'Anti-Retroviral Agents'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1667052', 'cui_str': 'maraviroc'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C1667052', 'cui_str': 'maraviroc'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C1619738', 'cui_str': 'Immune Restoration Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",416.0,0.753684,"Conclusion


Addition of maraviroc to standard c-ART does not improve clinical outcomes of patients initiating therapy for advanced HIV infection.
","[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Lévy', 'Affiliation': 'Vaccine Research Institute, Institut National de la Santé et de la Recherche médicale (INSERM), and Assistance Publique Hôpitaux de Paris (APHP), Hôpital H. Mondor, Créteil, France (Y.L., J.L.).'}, {'ForeName': 'Jean-Daniel', 'Initials': 'JD', 'LastName': 'Lelièvre', 'Affiliation': 'Vaccine Research Institute, Institut National de la Santé et de la Recherche médicale (INSERM), and Assistance Publique Hôpitaux de Paris (APHP), Hôpital H. Mondor, Créteil, France (Y.L., J.L.).'}, {'ForeName': 'Lambert', 'Initials': 'L', 'LastName': 'Assoumou', 'Affiliation': ""INSERM, Sorbonne Université, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP), Paris, France (L.A., R.L., L.B., D.C.).""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Aznar', 'Affiliation': 'Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica - Grupo de Estudio del SIDA, Madrid, Spain (E.A.).'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Pulido', 'Affiliation': 'Hospital Universitario 12 de Octubre, imas12, Universidad Complutense de Madrid (UCM), Madrid, Spain (F.P.).'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tambussi', 'Affiliation': 'Istituto di ricovero e cura a carattere scientifico-Ospedale San Raffaele, Milano, Italy (G.T.).'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Crespo', 'Affiliation': ""Hospital universitario Vall d'Hebron, Barcelona, Spain (M.C.).""}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Meybeck', 'Affiliation': 'Service Universitaire des Maladies Infectieuses et du Voyageur, Centre Hospitalier de Tourcoing, Tourcoing, France (A.M.).'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'INSERM U944, Université de Paris, Hôpital Saint-Louis, APHP, Paris, France (J.M., C.D.).'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Delaugerre', 'Affiliation': 'INSERM U944, Université de Paris, Hôpital Saint-Louis, APHP, Paris, France (J.M., C.D.).'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Izopet', 'Affiliation': 'INSERM, U1043, Université Toulouse III Paul-Sabatier, Faculté de Médecine Toulouse-Purpan, Toulouse, France (J.I.).'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Peytavin', 'Affiliation': 'Université Paris Diderot, Sorbonne Paris Cité, Laboratoire de Pharmacologie-Toxicologie, Hôpital Bichat-Claude Bernard, APHP, Paris, France (G.P.).'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Cardon', 'Affiliation': ""ANRS, France Recherche Nord & Sud Sida-hiv Hépatites, Agence autonome de l'INSERM, Paris, France (F.C., A.D.).""}, {'ForeName': 'Alpha', 'Initials': 'A', 'LastName': 'Diallo', 'Affiliation': ""ANRS, France Recherche Nord & Sud Sida-hiv Hépatites, Agence autonome de l'INSERM, Paris, France (F.C., A.D.).""}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Lancar', 'Affiliation': ""INSERM, Sorbonne Université, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP), Paris, France (L.A., R.L., L.B., D.C.).""}, {'ForeName': 'Lydie', 'Initials': 'L', 'LastName': 'Béniguel', 'Affiliation': ""INSERM, Sorbonne Université, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP), Paris, France (L.A., R.L., L.B., D.C.).""}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Costagliola', 'Affiliation': ""INSERM, Sorbonne Université, Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP), Paris, France (L.A., R.L., L.B., D.C.).""}]",Annals of internal medicine,['10.7326/M19-2133']
3135,31574151,Hepatitis B virus activity in untreated hepatitis B e antigen-negative human immunodeficiency virus-hepatitis B virus co-infected patients from sub-Saharan Africa.,"BACKGROUND


In human immunodeficiency virus (HIV) and hepatitis B virus (HBV) co-infected patients from sub-Saharan Africa with hepatitis B e antigen (HBeAg)-negative status, data are limited on the evolution of HBV activity when antiretroviral treatment (ART) is absent.
METHODS


A total of 43 HBeAg-negative co-infected patients not indicated for ART (per concomitant World Health Organization recommendations) were followed during participation in a randomized controlled trial in Côte d'Ivoire. Chronic HBeAg-negative phases were classified at yearly visits and defined as 'infection' (HBV DNA ≤10 000 copies/mL and normal alanine aminotransferase [ALT]) or 'hepatitis' (HBV DNA >10 000 copies/mL and/or above normal ALT). Dispersion in HBV DNA and ALT levels during follow-up was assessed using interquartile range (IQR) regression.
RESULTS


During a median 25 months (IQR 19-31), 17 (40%) patients consistently had 'infection', 5 (12%) consistently had 'hepatitis' and 21 (48%) fluctuated between phases. Wider dispersion in HBV DNA over time was associated with higher baseline HIV RNA (p=0.02) and higher baseline HBV DNA levels (p=0.008), while wider dispersion in ALT was associated with higher baseline HIV RNA (p<0.001), higher baseline ALT levels (p=0.02) and baseline hepatitis surface antigen >4.0 log10 IU/mL (p=0.02).
CONCLUSIONS


HBV activity is common with HBeAg-negative status, whose variation is partly linked to HIV replication. Fluctuations in disease phase make it difficult to assess the risk of morbidity and mortality after ART initiation.",2019,"Wider dispersion in HBV DNA over time was associated with higher baseline HIV RNA (p=0.02) and higher baseline HBV DNA levels (p=0.008), while wider dispersion in ALT was associated with higher baseline HIV RNA (p<0.001), higher baseline ALT levels (p=0.02) and baseline hepatitis surface antigen >4.0 log10 IU/mL (p=0.02).
","['human immunodeficiency virus (HIV) and hepatitis B virus (HBV) co-infected patients from sub-Saharan Africa with hepatitis B e antigen ', 'untreated hepatitis B e antigen-negative human immunodeficiency virus-hepatitis B virus co-infected patients from sub-Saharan Africa']","['ART', ""hepatitis' (HBV DNA >10 000 copies/mL and/or above normal ALT""]","['baseline ALT levels', 'Dispersion in HBV DNA and ALT levels', 'baseline HBV DNA levels']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001738', 'cui_str': 'Subsaharan Africa'}, {'cui': 'C0019167', 'cui_str': 'e Antigens'}, {'cui': 'C0948827', 'cui_str': 'Hepatitis B e antigen negative'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0019158', 'cui_str': 'Hepatitis'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332624', 'cui_str': 'Dispersion'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}]",,0.267632,"Wider dispersion in HBV DNA over time was associated with higher baseline HIV RNA (p=0.02) and higher baseline HBV DNA levels (p=0.008), while wider dispersion in ALT was associated with higher baseline HIV RNA (p<0.001), higher baseline ALT levels (p=0.02) and baseline hepatitis surface antigen >4.0 log10 IU/mL (p=0.02).
","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Boyd', 'Affiliation': ""INSERM, Sorbonne Université, Institut Pierre Louis d'Épidémiologie et de Santé Publique, Paris, France.""}, {'ForeName': 'Menan Gerard', 'Initials': 'MG', 'LastName': 'Kouamé', 'Affiliation': ""Programme PAC-CI, ANRS Research Site, Treichville University Hospital, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Houghtaling', 'Affiliation': 'Division of Epidemiology & Community Health, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Moh', 'Affiliation': ""Programme PAC-CI, ANRS Research Site, Treichville University Hospital, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Gabillard', 'Affiliation': 'INSERM, U1219, Epidémiologie-Biostatistique, Bordeaux, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Maylin', 'Affiliation': 'Laboratoire de Virologie, Hôpital Saint-Louis, AP-HP, Paris, France.'}, {'ForeName': 'Mariama', 'Initials': 'M', 'LastName': 'Abdou Chekaraou', 'Affiliation': 'Centre de Recherche sur le Cancer de Lyon, INSERM, Unité 1052, CNRS, UMR 5286, Lyon, France.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Delaugerre', 'Affiliation': 'Laboratoire de Virologie, Hôpital Saint-Louis, AP-HP, Paris, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Anglaret', 'Affiliation': ""Programme PAC-CI, ANRS Research Site, Treichville University Hospital, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Serge Paul', 'Initials': 'SP', 'LastName': 'Eholié', 'Affiliation': ""Programme PAC-CI, ANRS Research Site, Treichville University Hospital, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Danel', 'Affiliation': ""Programme PAC-CI, ANRS Research Site, Treichville University Hospital, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Zoulim', 'Affiliation': 'Centre de Recherche sur le Cancer de Lyon, INSERM, Unité 1052, CNRS, UMR 5286, Lyon, France.'}, {'ForeName': 'Karine', 'Initials': 'K', 'LastName': 'Lacombe', 'Affiliation': ""INSERM, Sorbonne Université, Institut Pierre Louis d'Épidémiologie et de Santé Publique, Paris, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Transactions of the Royal Society of Tropical Medicine and Hygiene,['10.1093/trstmh/trz021']
3136,32025817,Determining the difference in the efficacy and safety of self-expandable metallic stents as a bridge to surgery for obstructive colon cancer among patients in the CROSS 0 group and those in the CROSS 1 or 2 group: a pooled analysis of data from two Japanese prospective multicenter trials.,"PURPOSE


This study compared the feasibility and safety of endoscopic placement of self-expandable metallic stents (SEMSs) as a bridge to surgery (BTS) between patients with obstructive colorectal cancer (CRC) classified as ColoRectal Obstruction Scoring System (CROSS) 0 and those with CROSS 1 or 2.
METHODS


We conducted a post hoc analysis of two prospective, observational, single-arm multicenter clinical trials and performed a pooled analysis of the data. In total, 336 consecutive patients with malignant colorectal obstruction underwent SEMS placement. The primary endpoint was clinical success, defined as resolution of symptoms and radiological findings within 24 h. Secondary endpoints were technical success and adverse events.
RESULTS


High clinical (98.0% vs. 98.4%) and technical (96.7% vs. 97.8%) success rates were observed in both groups (CROSS 0 vs. CROSS 1 or 2). The adverse event rate was low. The mean stricture length was lower (3.8 ± 1.2 cm vs. 4.4 ± 1.8 cm) and laparoscopic surgery more common (56.7% vs 52.2%) in the CROSS 0 group than in the CROSS 1 and 2 group.
CONCLUSION


This study was the first to compare the degree of stricture in different CROSS groups and demonstrated comparable results with respect to the short-term efficacy and safety of SEMS placement as a BTS for obstructive CRC in CROSS 0, 1, and 2 patients.",2020,"The mean stricture length was lower (3.8 ± 1.2 cm vs. 4.4 ± 1.8 cm) and laparoscopic surgery more common (56.7% vs 52.2%) in the CROSS 0 group than in the CROSS 1 and 2 group.
","['336 consecutive patients with malignant colorectal obstruction underwent SEMS placement', 'patients with obstructive colorectal cancer (CRC) classified as ColoRectal Obstruction Scoring System (CROSS) 0 and those with CROSS 1 or 2', 'obstructive colon cancer among patients in the CROSS 0 group and those in the CROSS 1 or 2 group: a pooled analysis of data from two Japanese prospective multicenter trials']","['endoscopic placement of self-expandable metallic stents (SEMSs', 'SEMS placement', 'self-expandable metallic stents']","['success rates', 'mean stricture length', 'efficacy and safety', 'technical success and adverse events', 'degree of stricture', 'adverse event rate', 'clinical success, defined as resolution of symptoms and radiological findings']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0206012', 'cui_str': 'Multicenter Trials'}]","[{'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C4042807', 'cui_str': 'Self Expandable Metal Stents'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2607943', 'cui_str': 'findings'}]",336.0,0.0751036,"The mean stricture length was lower (3.8 ± 1.2 cm vs. 4.4 ± 1.8 cm) and laparoscopic surgery more common (56.7% vs 52.2%) in the CROSS 0 group than in the CROSS 1 and 2 group.
","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Ohki', 'Affiliation': ""Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan. ohki.takeshi@twmu.ac.jp.""}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': ""Department of Surgery, Institute of Gastroenterology, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Isayama', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Yamada', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Takeaki', 'Initials': 'T', 'LastName': 'Matsuzawa', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Kuwai', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Tomita', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Toshiyasu', 'Initials': 'T', 'LastName': 'Shiratori', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Shimada', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Tomio', 'Initials': 'T', 'LastName': 'Hirakawa', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Koizumi', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Saida', 'Affiliation': 'Japan Colonic Stent Safe Procedure Research Group, Tokyo, Japan.'}]",Surgery today,['10.1007/s00595-020-01970-3']
3137,23448807,"Global, multicenter, randomized, phase II trial of gemcitabine and gemcitabine plus AGS-1C4D4 in patients with previously untreated, metastatic pancreatic cancer.","BACKGROUND


We evaluated AGS-1C4D4, a fully human monoclonal antibody to prostate stem cell antigen (PSCA), with gemcitabine in a randomized, phase II study of metastatic pancreatic cancer.
PATIENTS AND METHODS


Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0/1 and previously untreated, metastatic pancreatic adenocarcinoma were randomly assigned 1:2 to gemcitabine (1000 mg/m(2) weekly seven times, 1 week rest, weekly three times q4weeks) or gemcitabine plus AGS-1C4D4 (48 mg/kg loading dose, then 24 mg/kg q3weeks IV). The primary end point was 6-month survival rate (SR). Archived tumor samples were collected for pre-planned analyses by PSCA expression.
RESULTS


Between April 2009 and May 2010, 196 patients were randomly assigned to gemcitabine (n = 63) or gemcitabine plus AGS-1C4D4 (n = 133). The 6-month SR was 44.4% (95% CI, 31.9-57.5) in the gemcitabine arm and 60.9% (95% CI, 52.1-69.2) in the gemcitabine plus AGS-1C4D4 arm (P = 0.03), while the median survival was 5.5 versus 7.6 months and the response rate was 13.1% versus 21.6% in the two arms, respectively. The 6-month SR was 57.1% in the gemcitabine arm versus 79.5% in the gemcitabine plus AGS-1C4D4 arm among the PSCA-positive subgroup and 31.6% versus 46.2% among the PSCA-negative subgroup.
CONCLUSIONS


This randomized, phase II study achieved its primary end point, demonstrating an improved 6-month SR with addition of AGS-1C4D4 to gemcitabine among patients with previously untreated, metastatic pancreatic adenocarcinoma. ClinicalTrials.gov identifier: NCT00902291.",2013,"The 6-month SR was 57.1% in the gemcitabine arm versus 79.5% in the gemcitabine plus AGS-1C4D4 arm among the PSCA-positive subgroup and 31.6% versus 46.2% among the PSCA-negative subgroup.
","['Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0/1 and previously untreated, metastatic pancreatic adenocarcinoma', 'Between April 2009 and May 2010', 'patients with previously untreated, metastatic pancreatic adenocarcinoma', '196 patients', 'patients with previously untreated, metastatic pancreatic cancer']","['gemcitabine plus AGS-1C4D4', 'gemcitabine', 'gemcitabine and gemcitabine plus AGS-1C4D4', 'AGS-1C4D4 to gemcitabine']","['6-month SR', 'response rate', 'median survival', '6-month survival rate (SR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2347292', 'cui_str': 'AGS-1C4D4 monoclonal antibody, human'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",196.0,0.0467505,"The 6-month SR was 57.1% in the gemcitabine arm versus 79.5% in the gemcitabine plus AGS-1C4D4 arm among the PSCA-positive subgroup and 31.6% versus 46.2% among the PSCA-negative subgroup.
","[{'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Wolpin', 'Affiliation': 'Dana-Farber Cancer Institute, Boston. Electronic address: bwolpin@partners.org.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': ""O'Reilly"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, USA.'}, {'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Ko', 'Affiliation': 'Sunnybrook Health Science Center, Toronto, Canada.'}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Blaszkowsky', 'Affiliation': 'Massachusettes General Hospital, Boston.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rarick', 'Affiliation': 'Kaiser Permanente Northwest Region Oncology Hematology, Portland.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Rocha-Lima', 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami, Miami.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Ritch', 'Affiliation': 'Medical College of Wisconsin, Milwaukee.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Chan', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Spratlin', 'Affiliation': 'Cross Cancer Institute, Edmonton, Alberta, Canada.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Macarulla', 'Affiliation': ""Hospital Vall d'Hebrón, Servicio de Oncología, Barcelona, Spain.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'McWhirter', 'Affiliation': 'Juravinski Cancer Centre, Hamilton, Ontario, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Pezet', 'Affiliation': 'Inserm U1071, Centre Hospitalier Universitaire Estaing, Clermont-Ferrand, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lichinitser', 'Affiliation': ""State Institution 'Blokhin Cancer Research Centre RAMS', Moscow.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Roman', 'Affiliation': ""State Healthcare Institution 'Leningrad Regional Oncologic Dispensary', Saint Petersburg, Russia.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hartford', 'Affiliation': 'Agensys, Inc., Santa Monica, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Morrison', 'Affiliation': 'Agensys, Inc., Santa Monica, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Jackson', 'Affiliation': 'Agensys, Inc., Santa Monica, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Vincent', 'Affiliation': 'Agensys, Inc., Santa Monica, USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Reyno', 'Affiliation': 'Agensys, Inc., Santa Monica, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hidalgo', 'Affiliation': ""Centro Integral Oncológico 'Clara Campal', Madrid; Centro Nacional de Investigaciones Oncologicas, Madrid, Spain.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt066']
3138,32005255,Socioeconomic position and the impact of increasing availability of lower energy meals vs. menu energy labelling on food choice: two randomized controlled trials in a virtual fast-food restaurant.,"BACKGROUND


Food consumed outside of the home is often high in energy and population level interventions that reduce energy intake of people from both lower and higher socioeconomic position (SEP) are needed. There is a lack of evidence on the effectiveness and SEP equity of structural-based (e.g. increasing availability of lower energy options) and information provision (e.g. menu energy labelling) interventions on food choice.
METHODS


Across two online experiments, participants of lower and higher SEP made meal choices in a novel virtual fast-food restaurant. To be eligible to take part, participants were required to be UK residents, aged 18 or above, fluent in English, have access to a computer with an internet connection and have no dietary restrictions. Participants were randomized to one of four conditions in a 2 × 2 between-subjects design: menu energy labelling present vs. absent and increased availability of lower energy options (75% of menu options lower energy) vs. baseline availability (25% of menu options lower energy). Participants also completed measures of executive function and food choice motives.
RESULTS


The analysis of pooled data from both studies (n = 1743) showed that increasing the availability of lower energy options resulted in participants ordering meals with significantly less energy on average (- 71 kcal, p <  0.001, partial η 2  = 0.024) and this effect was observed irrespective of participant SEP. Menu labelling had no significant effect on energy ordered (- 18 kcal, p = 0.116, partial η 2  = 0.001) in participants from both higher and lower SEP. Furthermore, we found no evidence that executive function or food choice motives moderated the effect of increasing lower energy menu options or energy labelling on total energy ordered.
CONCLUSIONS


In a virtual fast-food environment, energy labelling was ineffective in reducing total energy ordered for both higher and lower SEP participants. Increasing the availability of lower energy options had an equitable effect, reducing total energy ordered in participants from higher and lower SEP.
TRIAL REGISTRATION


Study protocols and analysis plans were pre-registered on the Open Science Framework (https://osf.io/ajcr6/).",2020,"Menu labelling had no significant effect on energy ordered (- 18 kcal, p = 0.116, partial η 2  = 0.001) in participants from both higher and lower SEP.","['participants were required to be UK residents, aged 18 or above, fluent in English, have access to a computer with an internet connection and have no dietary restrictions']","['lower energy meals vs. menu energy labelling', 'menu energy labelling present vs. absent and increased availability of lower energy options (75% of menu options lower energy) vs. baseline availability (25% of menu options lower energy']","['total energy', 'executive function and food choice motives', 'total energy ordered', 'availability of lower energy options', 'energy ordered']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",,0.201195,"Menu labelling had no significant effect on energy ordered (- 18 kcal, p = 0.116, partial η 2  = 0.001) in participants from both higher and lower SEP.","[{'ForeName': 'Lucile', 'Initials': 'L', 'LastName': 'Marty', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Eleanor Rathbone Building, Bedford Street South, Liverpool, L69 7ZA, UK. lucile.marty@liv.ac.uk.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Eleanor Rathbone Building, Bedford Street South, Liverpool, L69 7ZA, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychological Sciences, University of Liverpool, Eleanor Rathbone Building, Bedford Street South, Liverpool, L69 7ZA, UK. eric.robinson@liv.ac.uk.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-0922-2']
3139,23041591,"Adjuvant therapy with cetuximab for locally advanced squamous cell carcinoma of the oropharynx: results from a randomized, phase II prospective trial.","BACKGROUND


Cetuximab combined with radiotherapy (RT) is a treatment option for head and neck cancer. The objectives of this randomized, phase II trial were to evaluate the efficacy and safety of cetuximab maintenance therapy following definitive RT with concomitant cetuximab in patients with oropharyngeal cancer.
PATIENTS AND METHODS


Ninety-one patients with stage III-IV M0 oropharyngeal tumors were randomly assigned to the treatment with accelerated concomitant boost RT (69.9 Gy) + cetuximab or the same treatment with the addition of 12 consecutive weeks of cetuximab maintenance therapy. The primary end point was locoregional control (LRC) at 1 year.
RESULTS


LRC at 1 year was superior among patients in the experimental arm, treated with cetuximab maintenance (59% versus 47%). However, LRC was similar between both arms after 2 years of follow-up, as a result of increased locoregional recurrences after the first year in the maintenance group. Patients treated with adjuvant cetuximab do recover very soon from toxic effect after combined treatment.
CONCLUSIONS


Twelve weeks of cetuximab maintenance therapy after concomitant cetuximab + RT in locally advanced oropharyngeal carcinoma is feasible and improves clinical outcomes measured at 1 year. This improvement is not maintained after the second year suggesting that epidermal growth factor receptor blockade is not sufficient to completely eliminate the minimal residual disease.",2013,Twelve weeks of cetuximab maintenance therapy after concomitant cetuximab + RT in locally advanced oropharyngeal carcinoma is feasible and improves clinical outcomes measured at 1 year.,"['head and neck cancer', 'patients with oropharyngeal cancer', 'Ninety-one patients with stage III-IV M0 oropharyngeal tumors', 'locally advanced squamous cell carcinoma of the oropharynx', 'locally advanced oropharyngeal carcinoma']","['cetuximab maintenance therapy after concomitant cetuximab + RT', 'Cetuximab combined with radiotherapy (RT', 'adjuvant cetuximab', 'cetuximab maintenance therapy', 'accelerated concomitant boost RT (69.9 Gy) + cetuximab', 'cetuximab']","['efficacy and safety', 'locoregional recurrences', 'locoregional control (LRC']","[{'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2349952', 'cui_str': 'Cancer of Oropharnyx'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0521367', 'cui_str': 'Oropharynxs'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",91.0,0.0385203,Twelve weeks of cetuximab maintenance therapy after concomitant cetuximab + RT in locally advanced oropharyngeal carcinoma is feasible and improves clinical outcomes measured at 1 year.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mesía', 'Affiliation': ""Medical Oncology Department, IDIBELL, Institut Català d'Oncologia-L'Hospitalet, Barcelona. Electronic address: rmesia@iconcologia.net.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rueda', 'Affiliation': 'Medical Oncology Department, Complejo Hospitalario Virgen de la Victoria, Málaga.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vera', 'Affiliation': 'Medical Oncology Department, Complejo Hospitalario de Navarra, Pamplona.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lozano', 'Affiliation': ""Radiation Oncology Department, IDIBELL, Institut Català d'Oncologia-L'Hospitalet, Barcelona.""}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Medina', 'Affiliation': 'Radiation Oncology Department, Complejo Hospitalario Virgen de la Victoria, Málaga.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Aguiar', 'Affiliation': 'Medical Oncology Department, Hospital General Dr Negrín, Las Palmas de Gran Canaria.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Árias', 'Affiliation': 'Radiation Oncology Department, Complejo Hospitalario de Navarra, Pamplona.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Triana', 'Affiliation': 'Radiation Oncology Department, Centro Oncológico Regional de Galicia, A Coruña.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Carles', 'Affiliation': 'Medical Oncology Department, Hospital del Mar, Barcelona.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'López-López', 'Affiliation': 'Medical Oncology Department, Complejo Hospitalario Universitario de Santiago, Spain.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds291']
3140,19940014,"Fentanyl buccal soluble film (FBSF) for breakthrough pain in patients with cancer: a randomized, double-blind, placebo-controlled study.","BACKGROUND


Fentanyl buccal soluble film (FBSF) has been developed as a treatment of breakthrough pain in opioid-tolerant patients with cancer. The objective of this study was to evaluate the efficacy of FBSF at doses of 200-1200 microg in the management of breakthrough pain in patients with cancer receiving ongoing opioid therapy.
PATIENTS AND METHODS


This was a multicenter, randomized, double-blind, placebo-controlled, multiple-crossover study that included opioid-tolerant adult patients with chronic cancer pain who experienced one to four daily episodes of breakthrough pain. The primary efficacy assessment was the sum of pain intensity differences at 30 min (SPID30) postdose.
RESULTS


The intent-to-treat population consisted of 80 patients with > or =1 post-baseline efficacy assessment. The least-squares mean (LSM +/- SEM) of the SPID30 was significantly greater for FBSF-treated episodes of breakthrough pain than for placebo-treated episodes (47.9 +/- 3.9 versus 38.1 +/- 4.3; P = 0.004). There was statistical separation from placebo starting at 15 min up through 60 min (last time point assessed). There were no unexpected adverse events (AEs) or clinically significant safety findings.
CONCLUSIONS


FBSF is an effective option for control of breakthrough pain in patients receiving ongoing opioid therapy. In this study, FBSF was well tolerated in the oral cavity, with no reports of treatment-related oral AEs.",2010,SEM) of the SPID30 was significantly greater for FBSF-treated episodes of breakthrough pain than for placebo-treated episodes (47.9 +/-,"['adult patients with chronic cancer pain who experienced one to four daily episodes of breakthrough pain', 'opioid-tolerant patients with cancer', 'patients receiving ongoing opioid therapy', 'patients with cancer receiving ongoing opioid therapy', 'patients with cancer']","['FBSF', 'Fentanyl buccal soluble film (FBSF', 'placebo', 'opioid-tolerant']","['least-squares mean (LSM ', 'sum of pain intensity differences at 30 min (SPID30) postdose']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1135120', 'cui_str': 'Breakthrough Pain'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",80.0,0.424308,SEM) of the SPID30 was significantly greater for FBSF-treated episodes of breakthrough pain than for placebo-treated episodes (47.9 +/-,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rauck', 'Affiliation': 'Carolinas Pain Institute, Winston-Salem, NC.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'North', 'Affiliation': 'Carolinas Pain Institute, Winston-Salem, NC.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Gever', 'Affiliation': 'Meda Pharmaceuticals, Inc., Somerset, NJ, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Tagarro', 'Affiliation': 'Meda Pharmaceuticals, Madrid, Spain.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Finn', 'Affiliation': 'BioDelivery Sciences International, Inc., Raleigh, NC, USA. Electronic address: afinn@bdsinternational.com.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp541']
3141,31953863,"Daridorexant, a New Dual Orexin Receptor Antagonist to Treat Insomnia Disorder.","OBJECTIVE


To evaluate the dose-response relationship of daridorexant, a new dual orexin receptor antagonist, on sleep variables in subjects with insomnia disorder.
METHODS


Adults (≤64 years) with insomnia disorder were randomized (1:1:1:1:1:1) to receive daily oral placebo, daridorexant (5, 10, 25, or 50mg), or 10mg zolpidem for 30 days. The primary efficacy outcome was the change in wake time after sleep onset from baseline to days 1 and 2. Secondary outcome measures were change in latency to persistent sleep from baseline to days 1 and 2, change in subjective wake time after sleep onset, and subjective latency to sleep onset from baseline to week 4. Safety was also assessed.
RESULTS


Of 1,005 subjects screened, 359 (64% female) were randomized and received ≥1 dose. A significant dose-response relationship (multiple comparison procedure-modeling, 2-sided p < 0.001) was found in the reduction of wake after sleep onset and latency to persistent sleep from baseline to days 1 and 2 with daridorexant. These reductions were sustained through to days 28 and 29 (p = 0.050 and p = 0.042, respectively). Similar dose-dependent relationships were observed for subjective wake after sleep onset and subjective latency to sleep onset. The incidence of treatment-emergent adverse events was 35%, 38%, 38%, and 34% in subjects treated with 5, 10, 25, and 50mg daridorexant, respectively, compared with 30% for placebo, and 40% for 10mg zolpidem. There were no clinically relevant treatment-related serious adverse events. Four subjects withdrew due to adverse events.
INTERPRETATION


Daridorexant induced a dose-dependent reduction in wake time after sleep onset in subjects with insomnia disorder (Clinicaltrials.gov NCT02839200). Ann Neurol 2020;87:347-356.",2020,"These reductions were sustained through to Days 28&29 (p=0.050 and p=0.042, respectively).","['Adults (≤64\u2009years) with insomnia disorder', 'subjects with insomnia disorder', 'Of 1005 subjects screened, 359 (64% female']","['placebo', 'zolpidem', 'daily oral placebo, daridorexant', 'daridorexant']","['change in wake time after sleep onset', 'subjective wake after sleep onset and subjective latency to sleep onset', 'reduction of wake after sleep onset and latency to persistent sleep', 'incidence of treatment-emergent adverse events', 'change in latency to persistent sleep from baseline to Days 1&2, change in subjective wake time after sleep onset and subjective latency to sleep onset', 'Safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1005.0,0.217756,"These reductions were sustained through to Days 28&29 (p=0.050 and p=0.042, respectively).","[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'Sleep Unit, Department of Neurology, Neuropsychiatry: Epidemiological and Clinical Research, University of Montpellier, National Institute of Health and Medical Research, Montpellier University Hospital Center, Montpellier, France.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs Drug Development Corporation and Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Fietze', 'Affiliation': 'Center of Interdisciplinary Sleep Medicine, Charité-Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mayleben', 'Affiliation': 'CTI Clinical Research Center, Cincinnati, OH.'}, {'ForeName': 'Dalma', 'Initials': 'D', 'LastName': 'Seboek Kinter', 'Affiliation': 'Clinical Development, Idorsia Pharmaceuticals, Allschwil, Switzerland.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Pain', 'Affiliation': 'Clinical Development, Idorsia Pharmaceuticals, Allschwil, Switzerland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hedner', 'Affiliation': 'Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden.'}]",Annals of neurology,['10.1002/ana.25680']
3142,32000625,"Efficacy of gabapentin mouthwash in managing oral mucositis pain in patients undergoing chemotherapy: a prospective, randomised, double-blind, controlled clinical trial.",,2020,,['patients undergoing chemotherapy'],['gabapentin mouthwash'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0026647', 'cui_str': 'Oral Rinse'}]",[],,0.557392,,"[{'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Ala', 'Affiliation': 'Professor of Clinical Pharmacy, Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Zamani', 'Affiliation': 'Professor of Clinical Pharmacy, Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Jafar', 'Initials': 'J', 'LastName': 'Akbari', 'Affiliation': 'Pharmacy Student, Students Research Committee, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Salehifar', 'Affiliation': 'Professor of Clinical Pharmacy, Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ghasem', 'Initials': 'G', 'LastName': 'Janbabai', 'Affiliation': 'Professor of Pharmaceutics, Department of Pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Koulaeinejad', 'Affiliation': 'Professor of Clinical Pharmacy, Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}]",Scottish medical journal,['10.1177/0036933019897237']
3143,31948454,'Jump start' childcare-based intervention to promote physical activity in pre-schoolers: six-month findings from a cluster randomised trial.,"BACKGROUND


Participation in adequate levels of physical activity during the early years is important for health and development. We report the 6-month effects of an 18-month multicomponent intervention on physical activity in early childhood education and care (ECEC) settings in low-income communities.
METHODS


A cluster randomised controlled trial was conducted in 43 ECEC settings in disadvantaged areas of New South Wales, Australia. Three-year-old children were recruited and assessed in the first half of 2015 with follow-up 6 months later. The intervention was guided by Social Cognitive Theory and included five components. The primary outcome was minutes per hour in total physical activity during ECEC hours measured using Actigraph accelerometers. Intention-to-treat analysis of the primary outcome was conducted using a generalized linear mixed model.
RESULTS


A total of 658 children were assessed at baseline. Of these, 558 (85%) had valid accelerometer data (mean age 3.38y, 52% boys) and 508 (77%) had valid accelerometry data at 6-month follow-up. Implementation of the intervention components ranged from 38 to 72%. There were no significant intervention effects on mins/hr. spent in physical activity (adjusted difference = - 0.17 mins/hr., 95% CI (- 1.30 to 0.97), p = 0.78). A priori sub-group analyses showed a greater effect among overweight/obese children in the control group compared with the intervention group for mins/hr. of physical activity (2.35mins/hr., [0.28 to 4.43], p = 0.036).
CONCLUSIONS


After six-months the Jump Start intervention had no effect on physical activity levels during ECEC. This was largely due to low levels of implementation. Increasing fidelity may result in higher levels of physical activity when outcomes are assessed at 18-months.
TRIAL REGISTRATION


Australian New Zealand Clinical Trials Registry  ACTRN12614000597695.",2020,A priori sub-group analyses showed a greater effect among overweight/obese children in the control group compared with the intervention group for mins/hr.,"['43 ECEC settings in disadvantaged areas of New South Wales, Australia', 'Three-year-old children', 'early childhood education and care (ECEC) settings in low-income communities', '658 children']","[""Jump start' childcare-based intervention"", 'multicomponent intervention']","['spent in physical activity', 'physical activity levels', 'minutes per hour in total physical activity during ECEC hours measured using Actigraph accelerometers', 'valid accelerometer data']","[{'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0564385', 'cui_str': 'per hour'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",658.0,0.274325,A priori sub-group analyses showed a greater effect among overweight/obese children in the control group compared with the intervention group for mins/hr.,"[{'ForeName': 'Anthony D', 'Initials': 'AD', 'LastName': 'Okely', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, New South Wales, 2522, Australia. tokely@uow.edu.au.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Stanley', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, New South Wales, 2522, Australia.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Jones', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, New South Wales, 2522, Australia.'}, {'ForeName': 'Dylan P', 'Initials': 'DP', 'LastName': 'Cliff', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, New South Wales, 2522, Australia.'}, {'ForeName': 'Stewart G', 'Initials': 'SG', 'LastName': 'Trost', 'Affiliation': ""Institute of Health and Biomedical Innovation at Queensland Centre for Children's Health Research, School of Exercise and Nutrition Science, Queensland University of Technology, Brisbane, Queensland, Australia.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Berthelsen', 'Affiliation': 'School of Early Childhood, Queensland University of Technology, Kelvin Grove, Queensland, 4059, Australia.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Salmon', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Marijka', 'Initials': 'M', 'LastName': 'Batterham', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, New South Wales, 2522, Australia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Eckermann', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, New South Wales, 2522, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Reilly', 'Affiliation': 'School of Psychological Science and Health, University of Strathclyde, Glasgow, Scotland, UK.'}, {'ForeName': 'Ngiare', 'Initials': 'N', 'LastName': 'Brown', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, New South Wales, 2522, Australia.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Mickle', 'Affiliation': 'Institute of Health and Sport, Victoria University, Melbourne, Australia.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Howard', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, New South Wales, 2522, Australia.'}, {'ForeName': 'Trina', 'Initials': 'T', 'LastName': 'Hinkley', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, Australia.'}, {'ForeName': 'Xanne', 'Initials': 'X', 'LastName': 'Janssen', 'Affiliation': 'School of Psychological Science and Health, University of Strathclyde, Glasgow, Scotland, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Chandler', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, New South Wales, 2522, Australia.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Cross', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, New South Wales, 2522, Australia.'}, {'ForeName': 'Fay', 'Initials': 'F', 'LastName': 'Gowers', 'Affiliation': 'Early Start, Faculty of Social Sciences, University of Wollongong, Northfields Ave, Wollongong, New South Wales, 2522, Australia.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-0910-6']
3144,32020414,Exercise improves metformin 72-h glucose control by reducing the frequency of hyperglycemic peaks.,"PURPOSE


To determine the separated and combined effects of metformin and exercise on insulin sensitivity and free-living glycemic control in overweight individuals with prediabetes/type 2 diabetes (T2DM).
METHODS


We recruited 16 adults with BMI of 32.7 ± 4.3 kg m -2  and insulin resistance (HOMA-IR 3.2 ± 0.4) under chronic metformin treatment (1234 ± 465 g day -1 ) enrolled in a high-intensity interval training (HIIT) program. Participants underwent four 72-h experimental trials in a random-counterbalanced order: (1) maintaining their habitual metformin treatment (MET); (2) replacing metformin treatment by placebo (CON); (3) placebo plus two HIIT sessions (EX + CON), and (4) metformin plus two HIIT sessions (MET + EX). We used intermittently scanned continuous glucose monitoring (isCGM) during 72 h in every trial to obtain interstitial fluid glucose area under the curve (IFG AUC ) and the percentage of measurements over 180 mg dL -1  (% IFG PEAKS ). Insulin sensitivity was assessed on the last day of each trial with HOMA-IR index and calculated insulin sensitivity (C SI ) from intravenous glucose tolerance test.
RESULTS


IFG AUC  was lower in MET + EX and MET than in CON (P = 0.011 and P = 0.025, respectively). In addition, IFG AUC  was lower in MET + EX than in EX + CON (P = 0.044). %IFG PEAKS  were only lower in MET + EX in relation to CON (P = 0.028). HOMA-IR and C SI  were higher in CON in comparison with MET + EX (P = 0.011 and P = 0.022, respectively) and MET (P = 0.006 and P < 0.001, respectively). IFG AUC  showed a significant correlation with HOMA-IR.
CONCLUSION


Intense aerobic exercise in patients with diabetes and prediabetes under metformin treatment reduces free-living 72-h blood hyperglycemic peaks. This may help to prevent the development of cardiovascular complications associated with diabetes.",2020,%IFG PEAKS  were only lower in MET + EX in relation to CON (P = 0.028).,"['16 adults with BMI of 32.7\u2009±\u20094.3\xa0kg\xa0m -2  and insulin resistance (HOMA-IR 3.2\u2009±\u20090.4) under chronic metformin treatment (1234\u2009±\u2009465\xa0g\xa0day -1 ) enrolled in a high-intensity interval training (HIIT) program', 'patients with diabetes and prediabetes under', 'overweight individuals with prediabetes/type 2 diabetes (T2DM']","['metformin', 'metformin and exercise', 'intermittently scanned continuous glucose monitoring (isCGM', 'habitual metformin treatment (MET); (2) replacing metformin treatment by placebo (CON); (3) placebo plus two HIIT sessions (EX\u2009+\u2009CON), and (4) metformin plus two HIIT sessions (MET\u2009+\u2009EX', 'Intense aerobic exercise']","['frequency of hyperglycemic peaks', 'Insulin sensitivity', 'free-living 72-h blood hyperglycemic peaks', 'HOMA-IR and C SI', 'insulin sensitivity and free-living glycemic control', 'IFG AUC']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441633'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0005768'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",16.0,0.0313619,%IFG PEAKS  were only lower in MET + EX in relation to CON (P = 0.028).,"[{'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Ortega', 'Affiliation': 'Exercise Physiology Laboratory, University of Castilla-La Mancha, 45071, Toledo, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Morales-Palomo', 'Affiliation': 'Exercise Physiology Laboratory, University of Castilla-La Mancha, 45071, Toledo, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ramirez-Jimenez', 'Affiliation': 'Exercise Physiology Laboratory, University of Castilla-La Mancha, 45071, Toledo, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moreno-Cabañas', 'Affiliation': 'Exercise Physiology Laboratory, University of Castilla-La Mancha, 45071, Toledo, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mora-Rodríguez', 'Affiliation': 'Exercise Physiology Laboratory, University of Castilla-La Mancha, 45071, Toledo, Spain. ricardo.mora@uclm.es.'}]",Acta diabetologica,['10.1007/s00592-020-01488-7']
3145,32017373,Pseudophakic negative dysphotopsia and intraocular lens orientation: a prospective double-masked randomized controlled trial.,"PURPOSE


To determine whether horizontal orientation of the intraocular lens optic-haptic junctions has an effect on the incidence of pseudophakic negative dysphotopsia.
METHODS


Single-centre prospective double-masked randomized controlled trial. 220 eyes of 201 participants undergoing routine cataract surgery were randomized to receive their intraocular lens either orientated with the optic-haptic junctions at 180° ('horizontal') or without manipulation following implantation (control). Patients were excluded according to age (<19 and > 99 years), coexisting eye disease affecting visual function and insufficient cognitive function to complete the study. In the fourth postoperative week, a telephone interview was conducted to determine rates of negative dysphotopsia. The data were analysed to provide the relative risk of negative dysphotopsia with horizontal orientation of the intraocular lens (IOL) optic-haptic junctions compared with standard treatment.
RESULTS


Orientating the IOL optic-haptic junctions horizontally halved the incidence of pseudophakic negative dysphotopsia in the fourth postoperative week (9/110 in the intervention group; 18/110 in the control group; RR: 0.50, 95% confidence interval: 0.235-1.064, p = 0.072). The overall incidence of negative dysphotopsia was 12.2% (27/220 participating eyes). No intraoperative adverse effects of intraocular lens rotation were reported.
CONCLUSION


The simple intraoperative manoeuvre of rotating the intraocular lens to orientate the optic-haptic junctions at 180° may be a safe and effective measure to reduce the risk of developing postoperative pseudophakic negative dysphotopsia in the first postoperative month. This is the first report that demonstrates the benefit of horizontal optic-haptic junction positioning to be sustained beyond the first postoperative day.",2020,Orientating the IOL optic-haptic junctions horizontally halved the incidence of pseudophakic negative dysphotopsia in the fourth postoperative week (9/110 in the intervention group;,"['Patients were excluded according to age (<19 and >\xa099\xa0years), coexisting eye disease affecting visual function and insufficient cognitive function to complete the study', '220 eyes of 201 participants undergoing routine cataract surgery']","['intraocular lens optic-haptic junctions', ""intraocular lens either orientated with the optic-haptic junctions at 180° ('horizontal') or without manipulation following implantation (control"", 'Pseudophakic negative dysphotopsia and intraocular lens orientation']",['overall incidence of negative dysphotopsia'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0015397', 'cui_str': 'Eye Diseases'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0231180', 'cui_str': 'Insufficient'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}]","[{'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C0205144', 'cui_str': 'Junctional (qualifier value)'}, {'cui': 'C0424013', 'cui_str': 'Orientated (finding)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1644716', 'cui_str': 'Negative dysphotopsia'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1644716', 'cui_str': 'Negative dysphotopsia'}]",201.0,0.205869,Orientating the IOL optic-haptic junctions horizontally halved the incidence of pseudophakic negative dysphotopsia in the fourth postoperative week (9/110 in the intervention group;,"[{'ForeName': 'Gemma S L', 'Initials': 'GSL', 'LastName': 'Manasseh', 'Affiliation': 'The Royal United Hospital Bath NHS Trust, Bath, UK.'}, {'ForeName': 'Edward W J', 'Initials': 'EWJ', 'LastName': 'Pritchard', 'Affiliation': 'The Royal United Hospital Bath NHS Trust, Bath, UK.'}, {'ForeName': 'Alice E J', 'Initials': 'AEJ', 'LastName': 'Rothwell', 'Affiliation': 'The Royal United Hospital Bath NHS Trust, Bath, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Luck', 'Affiliation': 'The Royal United Hospital Bath NHS Trust, Bath, UK.'}]",Acta ophthalmologica,['10.1111/aos.14368']
3146,31881421,Effects of biophilic indoor environment on stress and anxiety recovery: A between-subjects experiment in virtual reality.,"Previous research has demonstrated the positive associations between outdoor nature contact and stress reduction. However, similar effects of incorporating natural elements into indoor environment (i.e. biophilic design) have been less well studied. We hypothesize that exposure to biophilic indoor environments help people recover from stress and anxiety and those effects differ among different types of biophilic elements. To test these hypotheses, we conducted a between-subjects experiment with 100 participants using virtual reality (VR). Participants were randomly assigned to experience one of four virtual offices (i.e. one non-biophilic base office and three similar offices enhanced with different biophilic design elements) after stressor tasks. Their physiological indicators of stress reaction, including heart rate variability, heart rate, skin conductance level and blood pressure, were measured by bio-monitoring sensors. Their anxiety level was measured by using State-Trait Anxiety Inventory test (short version). We found that participants in biophilic indoor environments had consistently better recovery responses after stressor compare to those in the non-biophilic environment, in terms of reduction on stress and anxiety. Effects on physiological responses are immediate after exposure to biophilic environments with the larger impacts in the first four minutes of the 6-minute recovery process. Additionally, these restorative effects differ among three different types of indoor biophilic environments. This research provides evidence that biophilic design elements that impact stress recovery and anxiety. It also demonstrated the potential that virtual reality may be a way to bring nature and its therapeutic benefits to patients in hospitals.",2020,"Their physiological indicators of stress reaction, including heart rate variability, heart rate, skin conductance level and blood pressure, were measured by bio-monitoring sensors.","['subjects experiment in virtual reality', '100 participants using virtual reality (VR']",['biophilic indoor environment'],"['anxiety level', 'stress and anxiety recovery', 'State-Trait Anxiety Inventory test (short version', 'heart rate variability, heart rate, skin conductance level and blood pressure', 'stress and anxiety', 'recovery responses']","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",100.0,0.0219307,"Their physiological indicators of stress reaction, including heart rate variability, heart rate, skin conductance level and blood pressure, were measured by bio-monitoring sensors.","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA; Population Health Sciences Program, Harvard Graduate School of Arts and Sciences, Cambridge, MA, USA. Electronic address: jieyin@hsph.harvard.edu.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Arfaei', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Catalano', 'Affiliation': 'Department of Data Sciences, Dana-Farber Cancer Institute, Boston, MA, USA; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Joseph G', 'Initials': 'JG', 'LastName': 'Allen', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Spengler', 'Affiliation': 'Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}]",Environment international,['10.1016/j.envint.2019.105427']
3147,31345044,Tailored Helicobacter pylori eradication based on prior intake of macrolide antibiotics allows the use of triple therapy with optimal results in an area with high clarithromycin resistance.,"BACKGROUND


the previous intake of macrolide antibiotics is associated with a failure to eradicate Helicobacter pylori (H. pylori) with clarithromycin-containing regimens. However, the standard triple therapy achieves eradication rates of over 90% in patients without a previous use of macrolides in our health area. The aim of this study was to evaluate the efficacy of an H. pylori eradication strategy based on the intake of macrolides by the patient during the previous years.
METHODS


one hundred and sixty-nine patients with H. pylori infection were prospectively included in the study. The electronic medical record of each patient was reviewed at the time of inclusion. Depending on their previous intake of macrolides, patients were assigned to one of two eradication regimens: group A) patients without a previous intake of macrolides received an optimized triple therapy for 14 days; and group B) patients with a previous intake of macrolides received bismuth quadruple therapy for ten days.
RESULTS


ninety-one patients (53.84%) without a previous intake of macrolides received an optimized triple therapy (group A) and 78 patients (46.15%) with a previous intake of macrolides received bismuth quadruple therapy (group B). In group A, the H. pylori eradication rates were 90.11% in the intention-to-treat and 95.35% in the per-protocol analysis. In group B, the H. pylori eradication rates were 85.89% in the intention-to-treat and 98.5% in the per-protocol analysis. The overall eradication rates obtained using this strategy were 88.16% (95% CI: 82.32-92.02%) in the intention-to-treat and 96.75% (95% CI: 92.59-98.94%) in the per-protocol analysis.
CONCLUSIONS


an H. pylori eradication strategy based on the intake of macrolides during the previous years achieves overall eradication rates close to 90% and allows the use of standard triple therapy in more than half of the patients from a health area with a high level of clarithromycin resistance.",2019,"The overall eradication rates obtained using this strategy were 88.16% (95% CI: 82.32-92.02%) in the intention-to-treat and 96.75% (95% CI: 92.59-98.94%) in the per-protocol analysis.
","['ninety-one patients (53.84%) without a previous intake of macrolides received an', 'one hundred and sixty-nine patients with H. pylori infection were prospectively included in the study']","['optimized triple therapy', 'macrolide antibiotics', 'bismuth quadruple therapy', 'clarithromycin']","['pylori eradication rates', 'overall eradication rates', 'eradication rates']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0003240', 'cui_str': 'Substance with macrolide structure and antibacterial mechanism of action (substance)'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003240', 'cui_str': 'Substance with macrolide structure and antibacterial mechanism of action (substance)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}]",169.0,0.038579,"The overall eradication rates obtained using this strategy were 88.16% (95% CI: 82.32-92.02%) in the intention-to-treat and 96.75% (95% CI: 92.59-98.94%) in the per-protocol analysis.
","[{'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Valle Muñoz', 'Affiliation': 'Aparato Digestivo, Complejo Hospitalario de Toledo, España.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Muñoz Gómez', 'Affiliation': 'Aparato Digestivo, Complejo Hospitalario de Toledo.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Sierra Bernal', 'Affiliation': 'Aparato Digestivo, Complejo Hospitalario de Toledo, ESPAÑA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'de Andrés', 'Affiliation': 'Universidad Jaume I .'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Gómez Hernando', 'Affiliation': 'Microbiología, Complejo Hospitalario de Toledo.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Gómez Rodríguez', 'Affiliation': 'Aparato Digestivo, Complejo Hospitalario de Toledo, ESPAÑA.'}]",Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva,['10.17235/reed.2019.6198/2019']
3148,30887687,"Ingestion of Steamed and Dehydrated Placenta Capsules Does Not Affect Postpartum Plasma Prolactin Levels or Neonatal Weight Gain: Results from a Randomized, Double-Bind, Placebo-Controlled Pilot Study.","INTRODUCTION


Clinical studies conducted in the early to mid-twentieth century, and recent self-reports by some maternal placentophagy practitioners, suggest that human maternal placentophagy improves breast milk quality and quantity, although little research has evaluated this claim. Some placentophagy providers and advocates suggest that increased prolactin levels after placenta ingestion could account for the purported lactation benefits. The current study was conducted to evaluate these claims by comparing plasma prolactin levels of women consuming steamed, dehydrated, and encapsulated placenta with those of women consuming a placebo. Neonatal weight gain was also compared between the 2 groups.
METHODS


A randomized, double-blind, placebo-controlled pilot trial was conducted in which postpartum women (N = 27) were given a supplement containing their dehydrated placenta (n = 12) or placebo (n = 15). Plasma prolactin concentrations were measured 4 times across late pregnancy and early postpartum, and neonatal weights were recorded 3 times over the first 3 weeks postpartum.
RESULTS


The results showed no statistically significant (P < .05) differences in either plasma prolactin levels or neonatal weight gain between groups.
DISCUSSION


Maternal consumption of steamed, dehydrated, and encapsulated placenta postpartum does not appear to affect maternal postpartum prolactin or neonatal weight in the first 3 weeks postpartum. Further research is needed to investigate the possible effects of variation in placenta preparation methods or daily intake on human lactation.",2019,"The results showed no statistically significant (P < .05) differences in either plasma prolactin levels or neonatal weight gain between groups.
","['postpartum women (N = 27', 'women consuming steamed, dehydrated, and encapsulated placenta with those of women consuming a']","['Ingestion of Steamed and Dehydrated Placenta Capsules', 'Placebo', 'placebo', 'supplement containing their dehydrated placenta']","['neonatal weights', 'Plasma prolactin concentrations', 'prolactin levels', 'maternal postpartum prolactin or neonatal weight', 'Neonatal weight gain', 'plasma prolactin levels or neonatal weight gain', 'Postpartum Plasma Prolactin Levels or Neonatal Weight Gain', 'plasma prolactin levels']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0038225', 'cui_str': 'Steam'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated (qualifier value)'}, {'cui': 'C0032043', 'cui_str': 'Placentome'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032043', 'cui_str': 'Placentome'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0857712', 'cui_str': 'Plasma prolactin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C1277971', 'cui_str': 'Plasma prolactin measurement'}]",27.0,0.510799,"The results showed no statistically significant (P < .05) differences in either plasma prolactin levels or neonatal weight gain between groups.
","[{'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Young', 'Affiliation': 'Nutrition and Reproduction Lab, Department of Anthropology, University of Nevada, Las Vegas, Las Vegas, Nevada.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Gryder', 'Affiliation': 'Department of Surgery, School of Medicine, University of Nevada, Las Vegas, Las Vegas, Nevada.'}, {'ForeName': 'Chad L', 'Initials': 'CL', 'LastName': 'Cross', 'Affiliation': 'Department of Environmental and Occupational Health, University of Nevada, Las Vegas, Las Vegas, Nevada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Zava', 'Affiliation': 'ZRT Laboratory, Beaverton, Oregon.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Norris', 'Affiliation': 'ZRT Laboratory, Beaverton, Oregon.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Benyshek', 'Affiliation': 'Nutrition and Reproduction Lab, Department of Anthropology, University of Nevada, Las Vegas, Las Vegas, Nevada.'}]",Journal of midwifery & women's health,['10.1111/jmwh.12955']
3149,32000630,Effect of vorapaxar on cardiovascular and limb outcomes in patients with peripheral artery disease with and without coronary artery disease: Analysis from the TRA 2°P-TIMI 50 trial.,"Intensive antithrombotic therapy reduces major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in patients with peripheral artery disease (PAD). Recent studies have suggested heterogeneity in risk and benefit in those with and without concomitant coronary artery disease (CAD) and peripheral revascularization. We evaluated the risk of MACE and MALE in patients with PAD stratified by history of concomitant CAD and prior peripheral revascularization and whether the efficacy and safety of vorapaxar were similar in these subgroups. The TRA 2°P-TIMI 50 trial randomized 26,449 patients with prior MI, ischemic stroke, or PAD to vorapaxar or placebo. This analysis examined the effect of vorapaxar in a broad population of 6136 patients with PAD. Overall, vorapaxar significantly reduced MACE (HR 0.85, 95% CI 0.73, 0.99;  p  = 0.034) and MALE (HR 0.70, 95% CI 0.53, 0.92;  p  = 0.011) in patients with PAD. The absolute risk reduction (ARR) for MACE was greater in patients with PAD and CAD versus those with PAD alone (-2.2% vs 0.1%: number needed to treat (NNT) 45 vs 1000). Conversely, the ARR for MALE was higher in those with prior lower extremity revascularization (2.5% vs 0.2%: NNT 40 vs 500). Vorapaxar increased major bleeding (HR 1.39, 95% CI 1.12, 1.71;  p  = 0.003). The net clinical outcome in all patients with PAD was reduced with vorapaxar (HR 0.82, 95% CI 0.72, 0.94;  p  = 0.004), with benefits driven by reductions in MACE for those with CAD and by reductions in MALE for those with prior peripheral revascularization. Among patients with PAD, vorapaxar resulted in a net clinical benefit; however, the drivers of benefit were heterogeneous, with greater reductions in MACE in those with concomitant CAD and greater reductions in MALE in those with prior lower extremity revascularization, and unclear benefit in patients with neither. These clinical characteristics may be useful in identifying the subgroups of patients with PAD most likely to benefit from potent antithrombotic therapies.  ClinicalTrials.gov Identifier: NCT00526474 .",2020,"Vorapaxar increased major bleeding (HR 1.39, 95% CI 1.12, 1.71;  p  = 0.003).","['patients with peripheral artery disease (PAD', 'patients with peripheral artery disease with and without coronary artery disease', '26,449 patients with prior MI, ischemic stroke, or PAD to vorapaxar or', 'patients with PAD stratified by history of concomitant CAD and prior peripheral revascularization', '6136 patients with PAD']","['placebo', 'MACE', 'Intensive antithrombotic therapy', 'vorapaxar']","['cardiovascular and limb outcomes', 'efficacy and safety of vorapaxar', 'major bleeding', 'extremity revascularization', 'absolute risk reduction (ARR) for MACE', 'ARR for MALE', 'major adverse cardiovascular events (MACE) and major adverse limb events (MALE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C2974521', 'cui_str': 'vorapaxar'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1096418', 'cui_str': 'Peripheral revascularisation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2974521', 'cui_str': 'vorapaxar'}]","[{'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2974521', 'cui_str': 'vorapaxar'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",26449.0,0.195795,"Vorapaxar increased major bleeding (HR 1.39, 95% CI 1.12, 1.71;  p  = 0.003).","[{'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Qamar', 'Affiliation': ""TIMI Study Group, Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Morrow', 'Affiliation': ""TIMI Study Group, Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Creager', 'Affiliation': 'Dartmouth-Hitchcock Heart and Vascular Center, Geisel School of Medicine at Dartmouth, Lebanon, NH, USA.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Scirica', 'Affiliation': ""TIMI Study Group, Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Olin', 'Affiliation': 'Zena and Michael A Weiner Cardiovascular Institute and Marie-Jose and Henry R Kravis Center for Cardiovascular Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Joshua A', 'Initials': 'JA', 'LastName': 'Beckman', 'Affiliation': 'Vanderbilt Heart and Vascular Institute, Nashville, TN, USA.'}, {'ForeName': 'Sabina A', 'Initials': 'SA', 'LastName': 'Murphy', 'Affiliation': ""TIMI Study Group, Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Marc P', 'Initials': 'MP', 'LastName': 'Bonaca', 'Affiliation': ""TIMI Study Group, Department of Medicine, Cardiovascular Division, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}]","Vascular medicine (London, England)",['10.1177/1358863X19892690']
3150,31612630,Intradialytic exercise with blood flow restriction: Something to add to hemodialysis adequacy? Findings from a crossover study.,"INTRODUCTION


Hemodialysis (HD) increases the lifespan of chronic kidney disease (CKD) patients. However, HD is only partially effective in replacing renal function. The aim of this study is to compare HD adequacy between sessions with intradialytic exercise with or without blood flow restriction (BFR) with sessions without exercise.
METHODS


A crossover study including 22 adult CKD patients on HD. The patients were assigned to BFR (n = 11) or exercise alone group (n = 11). Each patient was submitted to four HD sessions (two with exercise and two control sessions). HD adequacy was assessed by equilibrated Kt/V-urea (eKT/V), single-pool Kt/V-urea (sp-Kt/V), urea and phosphorus rebound, urea reduction ratio (URR) and removal of urea and phosphorus in dialysate.
FINDINGS


BFR exercise improved eKt/V and sp-Kt/V (1.32 ± 0.21 vs. 1.10 ± 0.16 for control, P < 0.001; 1.53 ± 0.26 vs. 1.27 ± 0.19 for control, P < 0.001, respectively) and URR (72.5 ± 5.4% vs. 66.1 ± 7.7% for control, P < 0.001). No difference in eKt/V, sp-Kt/V or URR could be detected between exercise alone and control HD sessions. Urea rebound was lower in BFR exercise vs. control sessions (-8.9 ± 9.1% vs. 30.7 ± 12.8%, P < 0.01) and exercise alone vs. control sessions (13.3 ± 29.0% vs. 42.4 ± 15.3%, P < 0.01). Phosphorus rebound was marginally lower in exercise vs. control sessions (14.4 ± 19.1% vs. 28.4 ± 22.1%, P = 0.18). Urea and phosphorus mass removal in dialysate were marginally higher in exercise vs. control sessions (42.2 ± 19.4 g vs. 35.7 ± 12.5 g, P = 0.24; 912.1 ± 360.9 mg vs. 778.6 ± 245.1 mg, P = 0.28).
CONCLUSIONS


Intradialytic exercise with BFR was more effective than standard exercise in increasing HD adequacy.",2020,"No difference in eKt/V, sp-Kt/V or URR could be detected between exercise alone and control HD sessions.","['chronic kidney disease (CKD) patients', '22 adult CKD patients on HD']","['standard exercise', 'Hemodialysis (HD', 'intradialytic exercise with or without blood flow restriction (BFR) with sessions without exercise', 'Intradialytic exercise with blood flow restriction', 'BFR', 'exercise alone']","['urea and phosphorus rebound, urea reduction ratio (URR) and removal of urea and phosphorus in dialysate', 'URR', 'Urea and phosphorus mass removal in dialysate', 'BFR exercise improved eKt/V and sp-Kt/V', 'eKt/V, sp-Kt/V or URR', 'Urea rebound', 'Phosphorus rebound', 'HD adequacy']","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}]","[{'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0429664', 'cui_str': 'Urea reduction ratio (observable entity)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0011947', 'cui_str': 'Dialyzates'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0429662', 'cui_str': 'kt/V (observable entity)'}]",,0.014608,"No difference in eKt/V, sp-Kt/V or URR could be detected between exercise alone and control HD sessions.","[{'ForeName': 'Etiene C', 'Initials': 'EC', 'LastName': 'Dias', 'Affiliation': 'Postgraduate Program in Health and Behavior, Catholic University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Orcy', 'Affiliation': 'Physiology Department, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Maria F', 'Initials': 'MF', 'LastName': 'Antunes', 'Affiliation': 'Postgraduate Program in Health and Behavior, Catholic University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Kohn', 'Affiliation': 'Postgraduate Program in Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Airton J', 'Initials': 'AJ', 'LastName': 'Rombaldi', 'Affiliation': 'Postgraduate Program in Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Ribeiro', 'Affiliation': 'Postgraduate Program in Health and Behavior, Catholic University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Jean P', 'Initials': 'JP', 'LastName': 'Oses', 'Affiliation': 'Postgraduate Program in Health and Behavior, Catholic University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Ferreira', 'Affiliation': 'Physiology Department, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Aline M', 'Initials': 'AM', 'LastName': 'Araújo', 'Affiliation': 'Postgraduate Program in Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Isis F', 'Initials': 'IF', 'LastName': 'Boff', 'Affiliation': 'Postgraduate Program in Health and Behavior, Catholic University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Maristela', 'Initials': 'M', 'LastName': 'Böhlke', 'Affiliation': 'Postgraduate Program in Health and Behavior, Catholic University of Pelotas, Pelotas, Brazil.'}]",Hemodialysis international. International Symposium on Home Hemodialysis,['10.1111/hdi.12793']
3151,30466622,Effect of Artemisia annua and Artemisia afra tea infusions on schistosomiasis in a large clinical trial.,"BACKGROUND AND OBJECTIVE


Schistosomiasis (bilharzia), a serious neglected tropical disease affecting millions, has few cost-effective treatments, so two Artemisia wormwood species, A. annua and A. afra, were compared with the current standard praziquantel (PZQ) treatment in an 800 patient clinical trial, August-November of 2015.
METHODS


The double blind, randomized, superiority clinical trial had three treatment arms: 400 for PZQ, 200 for A. annua, and 200 for A. afra. PZQ-treated patients followed manufacturer posology. Artemisia-treated patients received 1 l/d of dry leaf/twig tea infusions divided into 3 aliquots daily, for 7 days with 28-day follow-up.
RESULTS


Of 800 enrolled patients having an average of >700 Schistosoma mansoni eggs per fecal sample, 780 completed the trial. Within 14 days of treatment, all Artemisia-treated patients had no detectable eggs in fecal smears, a result sustained 28 days post treatment. Eggs in fecal smears of PZQ-treated patients were undetectable after D21. More males than females who entered the trial had melena, but both genders responded equally well to treatment; by D28 melena disappeared in all patients. In all arms, eosinophil levels declined by about 27% from D0 to D28. From D0 to D28 hemoglobin increases were greater in PZQ and A. afra-treated patients than in A. annua-treated patients. Hematocrit increases were greater from D0 to D28 for patients treated with either PZQ or A. annua compared to those treated with A. afra. Gender comparison showed that A. afra-treated males had significantly greater hemoglobin and hematocrit increases by D28 than either PZQ or A. annua-treated males. In contrast, PZQ and A. afra-treated females had greater hemoglobin and hematocrit increases than A. annua-treated females. Both adults and pediatric patients treated with A. annua responded better compared to PZQ treatment.
CONCLUSION


Both A. annua and A. afra provided faster effective treatment of schistosomiasis and should be considered for implementation on a global scale.",2018,Hematocrit increases were greater from D0 to D28 for patients treated with either PZQ or A. annua compared to those treated with A. afra.,"['800 enrolled patients having an average of >700 Schistosoma mansoni eggs per fecal sample, 780 completed the trial', '800 patient clinical trial, August-November of 2015', ' 400 for PZQ, 200 for A. annua, and 200 for A. afra']","['praziquantel (PZQ', 'PZQ', 'Artemisia annua and Artemisia afra tea infusions', 'PZQ-treated patients followed manufacturer posology']","['Hematocrit increases', 'eosinophil levels', 'fecal smears', 'hemoglobin and hematocrit']","[{'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C4038804', 'cui_str': 'Schistosoma mansoni ovum'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0686899', 'cui_str': 'Sweet Annie'}, {'cui': 'C0331308', 'cui_str': 'Sagebrush'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0239935', 'cui_str': 'Hematocrit high'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0475363', 'cui_str': 'Fecal smear (specimen)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}]",800.0,0.102374,Hematocrit increases were greater from D0 to D28 for patients treated with either PZQ or A. annua compared to those treated with A. afra.,"[{'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Munyangi', 'Affiliation': 'Faculté de Médecine Université de Kolwesi/Lualaba, Democratic Republic of the Congo.'}, {'ForeName': 'Lucile', 'Initials': 'L', 'LastName': 'Cornet-Vernet', 'Affiliation': ""Vice Présidente de La Maison de l'Artemisia(association Loi 1901), 20 rue Pierre Demours, 75017Paris, France. Electronic address: lcv@maison-artemisia.org.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Idumbo', 'Affiliation': 'Centre de Santé de Lubile, Maniema, Democratic Republic of the Congo.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Department of Mathematics, Worcester Polytechnic Institute, USA.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Lutgen', 'Affiliation': 'Association IFVB-BELHERB, Luxembourg.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Perronne', 'Affiliation': 'Faculté de Médecine de Paris IDF Ouest, France.'}, {'ForeName': 'Nadège', 'Initials': 'N', 'LastName': 'Ngombe', 'Affiliation': 'Faculté de Pharmacie, Université de Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Bianga', 'Affiliation': 'Programme National Lutte Contre le Paludisme, Maniema, Democratic Republic of the Congo.'}, {'ForeName': 'Bavon', 'Initials': 'B', 'LastName': 'Mupenda', 'Affiliation': 'Ecole de Santé Publique Université de Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lalukala', 'Affiliation': 'Ministère Provincial de Santé Publique Maniema, Democratic Republic of the Congo.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Mergeai', 'Affiliation': 'Université de Liège, Belgium.'}, {'ForeName': 'Dieudonné', 'Initials': 'D', 'LastName': 'Mumba', 'Affiliation': 'Faculté de Médecine Université de Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Towler', 'Affiliation': 'Department of Biology and Biotechnology, Worcester Polytechnic Institute, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Weathers', 'Affiliation': 'Department of Biology and Biotechnology, Worcester Polytechnic Institute, USA.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2018.10.014']
3152,20335368,Quality of life of patients receiving platinum-based chemotherapy plus cetuximab first line for recurrent and/or metastatic squamous cell carcinoma of the head and neck.,"BACKGROUND


A phase III trial demonstrated that cetuximab is the first agent in 30 years to improve survival when added to platinum-based chemotherapy (platinum-fluorouracil) first line for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). This analysis of the trial assessed the impact of treatment on quality of life (QoL).
PATIENTS AND METHODS


The European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (QLQ-C30) and QLQ-Head and Neck 35 (QLQ-H&N35) module were used to assess QoL.
RESULTS


Of 442 patients randomly assigned, 291 (QLQ-C30) and 289 (QLQ-H&N35) patients completed at least one evaluable questionnaire. For QLQ-C30, cycle 3 and month 6 mean scores for platinum-fluorouracil plus cetuximab were not significantly worse than those for platinum-fluorouracil. Pattern-mixture analysis demonstrated a significant improvement in the global health status/QoL score in the cetuximab arm (P = 0.0415) but no treatment differences in the social functioning scale. For QLQ-H&N35, the mean score for the cetuximab arm was not significantly worse than that for the chemotherapy arm for all symptom scales at all post-baseline visits. At cycle 3, some symptom scores significantly favored the cetuximab arm (pain, swallowing, speech problems, and social eating).
CONCLUSION


Adding cetuximab to platinum-fluorouracil does not adversely affect the QoL of patients with recurrent and/or metastatic SCCHN.",2010,Adding cetuximab to platinum-fluorouracil does not adversely affect the QoL of patients with recurrent and/or metastatic SCCHN.,"['recurrent and/or metastatic squamous cell carcinoma of the head and neck', '442 patients randomly assigned, 291 (QLQ-C30) and 289 (QLQ-H&N35) patients completed at least one evaluable questionnaire', 'patients with recurrent and/or metastatic SCCHN', 'recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN']","['cetuximab to platinum-fluorouracil', 'platinum-based chemotherapy (platinum-fluorouracil', 'platinum-based chemotherapy plus cetuximab first line', 'platinum-fluorouracil', 'cetuximab', 'platinum-fluorouracil plus cetuximab']","['Quality of life', 'social functioning scale', 'global health status/QoL score', 'cetuximab arm (pain, swallowing, speech problems, and social eating', 'quality of life (QoL']","[{'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C2585826', 'cui_str': 'Social functioning scale (assessment scale)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011167', 'cui_str': 'Swallowing'}, {'cui': 'C0395016', 'cui_str': 'Speech problem (finding)'}]",442.0,0.0301589,Adding cetuximab to platinum-fluorouracil does not adversely affect the QoL of patients with recurrent and/or metastatic SCCHN.,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mesía', 'Affiliation': 'Department of Medical Oncology, Catalan Institute of Oncology, Hospitalet de Llobregat, Barcelona, Spain.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': 'Medical Oncology Department, Marqués de Valdecilla University Hospital, Santander, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kawecki', 'Affiliation': 'Head and Neck Cancer Department, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rottey', 'Affiliation': 'Medical Oncology, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hitt', 'Affiliation': ""Medical Oncology Department, University Hospital '12 de Octubre', Madrid, Spain.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kienzer', 'Affiliation': '3rd Medical Department, Kaiser Franz Josef Spital, Ludwig Boltzmann Institute for Applied Cancer Research, Vienna, Austria.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cupissol', 'Affiliation': ""Department of Medical Oncology, Val d'Aurelle-Paul Lamarque Regional Cancer Centre, Montpellier, France.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'De Raucourt', 'Affiliation': 'Head and Neck Unit, François Baclesse Centre, Caen, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Benasso', 'Affiliation': 'Oncology Department, San Paolo Hospital, Savona Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Koralewski', 'Affiliation': 'Oncology, Rydygier Memorial Hospital, Krakow-Nowa Huta, Poland.'}, {'ForeName': 'J-P', 'Initials': 'JP', 'LastName': 'Delord', 'Affiliation': 'Department of Medical Oncology, Claudius Regaud Institute, Toulouse, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'Department of Oncology, Hematology, BMT with section Pneumology, Hubertus Wald Tumorzentrum, University Cancer Center Hamburg, University Hospital, Hamburg, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Curran', 'Affiliation': 'Statistics, OMEGA Research, Santry, Dublin, Ireland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gross', 'Affiliation': 'Global Statistics, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Vermorken', 'Affiliation': 'Department of Medical Oncology, Antwerp University Hospital, Edegem, Belgium. Electronic address: jan.b.vermorken@uza.be.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq077']
3153,31993878,Sensory Perception in Blind Bilinguals and Monolinguals.,"In blinds, the tactile sensations play a crucial role for various daily activities, in the all sense modalities tactile sensation is considered as major sense of perception. This study is conducted to investigate the tactile sensations in relation to Bilingual and Monolingual blinds using experimental comparative study design, divided into two groups. Self-paced reading task of a Braille scripted passage was used as a stimulus. Findings of this study reported that blind bilingual participants differ in the processing of language, the tactile sensations in the Bilinguals are better as compared to monolinguals.",2020,"Findings of this study reported that blind bilingual participants differ in the processing of language, the tactile sensations in the Bilinguals are better as compared to monolinguals.",[],[],"['processing of language, the tactile sensations', 'tactile sensations']",[],[],"[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0702221', 'cui_str': 'Sense of Touch'}]",,0.0141838,"Findings of this study reported that blind bilingual participants differ in the processing of language, the tactile sensations in the Bilinguals are better as compared to monolinguals.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Phani Krishna', 'Affiliation': 'Centre for Neural and Cognitive Sciences, School of Medical Sciences, University of Hyderabad, Hyderabad, 500046, India. phanikrishna1992@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Arulmozi', 'Affiliation': 'Centre for Applied Linguistics and Translational Studies, School of Humanities, University of Hyderabad, Hyderabad, 500046, India.'}, {'ForeName': 'Male', 'Initials': 'M', 'LastName': 'Shiva Ram', 'Affiliation': 'Optometry and Vision Science, School of Medical Sciences, University of Hyderabad, Hyderabad, 500046, India.'}, {'ForeName': 'Ramesh Kumar', 'Initials': 'RK', 'LastName': 'Mishra', 'Affiliation': 'Centre for Neural and Cognitive Sciences, School of Medical Sciences, University of Hyderabad, Hyderabad, 500046, India.'}]",Journal of psycholinguistic research,['10.1007/s10936-020-09689-5']
3154,31992545,Forty-five per cent lower acute injury incidence but no effect on overuse injury prevalence in youth floorball players (aged 12-17 years) who used an injury prevention exercise programme: two-armed parallel-group cluster randomised controlled trial.,"OBJECTIVE


To study whether an injury prevention exercise programme would reduce the number of injuries in youth floorball players. METHODS : 81 youth community level floorball teams (48 clusters=clubs) with female and male players (12-17 years) were cluster-randomised into an intervention or control group. Intervention group coaches were instructed to use the Swedish  Knee Control  programme and a standard running warm-up before every training session, and the running warm-up before every match, during the season. Control teams continued usual training. Teams were followed during the 2017/2018 competitive season (26 weeks). Player exposure to floorball and occurrence of acute and overuse injuries were reported weekly via a web-based player survey using the Oslo Sports Trauma Research Centre Questionnaire. RESULTS : 17 clusters (301 players) in the intervention group and 12 clusters (170 players) in the control group were included for analyses. There were 349 unique injuries in 222 players. The intervention group had a 35% lower incidence of injuries overall than the control group (adjusted incidence rate ratio (IRR) 0.65, 95% CI 0.52 to 0.81). The absolute risk reduction was 6.6% (95% CI 3.2 to 10.0), and the number needed to treat was 152 hours of floorball exposure (95% CI 100 to 316). Intervention group teams had a 45% lower incidence of acute injuries (adjusted IRR 0.55, 95% CI 0.37 to 0.83). There was no difference in the prevalence of overuse injuries (adjusted prevalence rate ratio 0.96, 95% CI 0.73 to 1.26). CONCLUSION : The  Knee Control  injury prevention programme reduced acute injuries in youth floorball players; there was no effect on overuse injuries.
TRIAL REGISTRATION NUMBER


Clinical Trials NCT03309904.",2020,"The  Knee Control  injury prevention programme reduced acute injuries in youth floorball players; there was no effect on overuse injuries.
","[' 81 youth community level floorball teams (48 clusters=clubs) with female and male players (12-17 years', '349 unique injuries in 222 players', 'youth floorball players', 'youth floorball players (aged 12-17 years) who used an injury prevention exercise programme']","['Intervention group coaches were instructed to use the Swedish  Knee Control  programme and a standard running warm-up before every training session', 'injury prevention exercise programme']","['incidence of injuries overall', 'overuse injury prevalence', 'absolute risk reduction', 'number of injuries', 'acute injuries', 'prevalence of overuse injuries', 'incidence of acute injuries', 'overuse injuries']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0149651', 'cui_str': 'Clubbing (morphologic abnormality)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035127', 'cui_str': 'Repetitive Stress Injury'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.124536,"The  Knee Control  injury prevention programme reduced acute injuries in youth floorball players; there was no effect on overuse injuries.
","[{'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Åkerlund', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Waldén', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Sport Without Injury ProgrammE (SWIPE), Linköping University, Linköping, Sweden.'}, {'ForeName': 'Sofi', 'Initials': 'S', 'LastName': 'Sonesson', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hägglund', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy, Linköping University, Linköping, Sweden martin.hagglund@liu.se.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101295']
3155,32001517,Effectiveness of an e-health tennis-specific injury prevention programme: randomised controlled trial in adult recreational tennis players.,"BACKGROUND


Despite reported injury rates of up to 3 per 1000 hours exposure, there are no evidence-based prevention programmes in tennis.
PURPOSE


To evaluate the effectiveness of an e-health prevention programme for reducing tennis injury prevalence.
STUDY DESIGN


Two-arm, researcher-blinded randomised controlled trial.
METHODS


Adult tennis players of all playing levels were randomised in an unsupervised programme lasting 12 weeks (TennisReady group or control group). The primary outcome was the overall injury prevalence over a 16-week period, measured at 2 weekly intervals with the Oslo Sports and Trauma Research Centre questionnaire. Estimates for the primary outcome and associated 95% CIs were obtained using generalised estimating equation models. Secondary outcome scores included prevalence of substantial injuries, overall incidence, adherence and time-loss injuries.
RESULTS


A total of 579 (83%) (TennisReady n=286, control n=293) participants were included in the primary analysis. The mean injury prevalence was 37% (95% CI 33% to 42%) in the TennisReady vs 38% (95% CI 34% to 42%) in the control group (adjusted p-value 0.93). The prevalence of substantial injuries was 11% (95% CI 9% to 14%) in the TennisReady vs 12% (95% CI 9% to 15%) in the control group (p value of 0.79). Analysis of the secondary outcome scores showed no difference between groups. The mean prevalence rates between high (8%) and low (92%) adherent groups were 32% (95% CI 23% to 44%) and 37% (95% CI 33% to 42%), respectively (p value 0.36).
CONCLUSION


Providing an unsupervised e-health tennis-specific exercise programme did not reduce the injury rates and should not be implemented.
TRIAL REGISTRATION NUMBER


NTR6443.",2020,"Providing an unsupervised e-health tennis-specific exercise programme did not reduce the injury rates and should not be implemented.
","['A total of 579 (83%) (TennisReady n=286, control n=293) participants were included in the primary analysis', 'Adult tennis players of all playing levels', 'adult recreational tennis players']","['e-health tennis-specific injury prevention programme', 'e-health prevention programme', 'unsupervised programme lasting 12 weeks (TennisReady group or control group']","['prevalence of substantial injuries, overall incidence, adherence and time-loss injuries', 'mean prevalence rates', 'mean injury prevalence', 'overall injury prevalence over a 16-week period, measured at 2 weekly intervals with the Oslo Sports and Trauma Research Centre questionnaire', 'prevalence of substantial injuries']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0039515', 'cui_str': 'Tennis'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0150638', 'cui_str': 'Preventing injury (procedure)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.386742,"Providing an unsupervised e-health tennis-specific exercise programme did not reduce the injury rates and should not be implemented.
","[{'ForeName': 'Haiko Ivo Maria Franciscus Lodewijk', 'Initials': 'HIMFL', 'LastName': 'Pas', 'Affiliation': 'Amsterdam UMC, Univ of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Babette M', 'Initials': 'BM', 'LastName': 'Pluim', 'Affiliation': 'Amsterdam Collaboration on Health & Safety in Sports (ACHSS), Amsterdam UMC IOC Research Center of Excellence, Amsterdam, The Netherlands.'}, {'ForeName': 'Ozgur', 'Initials': 'O', 'LastName': 'Kilic', 'Affiliation': 'Amsterdam UMC, Univ of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Evert', 'Initials': 'E', 'LastName': 'Verhagen', 'Affiliation': 'Amsterdam Collaboration on Health & Safety in Sports (ACHSS), Amsterdam UMC IOC Research Center of Excellence, Amsterdam, The Netherlands.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gouttebarge', 'Affiliation': 'Amsterdam UMC, Univ of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Holman', 'Affiliation': 'Clinical Research Unit, Amsterdam University Medical Centres, Amsterdam, Noord-Holland, The Netherlands.'}, {'ForeName': 'Maarten H', 'Initials': 'MH', 'LastName': 'Moen', 'Affiliation': 'Amsterdam UMC, Univ of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Gino M', 'Initials': 'GM', 'LastName': 'Kerkhoffs', 'Affiliation': 'Amsterdam UMC, Univ of Amsterdam, Department of Orthopaedic Surgery, Amsterdam Movement Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Johannes L', 'Initials': 'JL', 'LastName': 'Tol', 'Affiliation': 'Academic Center for Evidence-based Sports medicine (ACES), Amsterdam UMC, Amsterdam Movement Sciences, Amsterdam, The Netherlands j.l.tol@amsterdamumc.nl.'}]",British journal of sports medicine,['10.1136/bjsports-2019-101142']
3156,32156749,A Randomized Phase II Preoperative Study of Autophagy Inhibition with High-Dose Hydroxychloroquine and Gemcitabine/Nab-Paclitaxel in Pancreatic Cancer Patients.,"PURPOSE


We hypothesized that autophagy inhibition would increase response to chemotherapy in the preoperative setting for patients with pancreatic adenocarcinoma. We performed a randomized controlled trial to assess the autophagy inhibitor hydroxychloroquine in combination with gemcitabine and nab-paclitaxel.
PATIENTS AND METHODS


Participants with potentially resectable tumors were randomized to two cycles of nab-paclitaxel and gemcitabine (PG) alone or with hydroxychloroquine (PGH), followed by resection. The primary endpoint was histopathologic response in the resected specimen. Secondary clinical endpoints included serum CA 19-9 biomarker response and margin negative R0 resection. Exploratory endpoints included markers of autophagy, immune infiltrate, and serum cytokines.
RESULTS


Thirty-four patients in the PGH arm and 30 in the PG arm were evaluable for the primary endpoint. The PGH arm demonstrated statistically improved Evans grade histopathologic responses ( P  = 0.00016), compared with control. In patients with elevated CA 19-9, a return to normal was associated with improved overall and recurrence-free survival ( P  < 0.0001). There were no differences in serious adverse events between arms and chemotherapy dose number was equivalent. The PGH arm had greater evidence of autophagy inhibition in their resected specimens (increased SQSTM1,  P  = 0.027, as well as increased immune cell tumor infiltration,  P  = 0.033). Overall survival ( P  = 0.59) and relapse-free survival ( P  = 0.55) did not differ between the two arms.
CONCLUSIONS


The addition of hydroxychloroquine to preoperative gemcitabine and nab-paclitaxel chemotherapy in patients with resectable pancreatic adenocarcinoma resulted in greater pathologic tumor response, improved serum biomarker response, and evidence of autophagy inhibition and immune activity.",2020,"In patients with elevated CA 19-9, a return to normal was associated with improved overall and recurrence-free survival (P < 0.0001).","['patients with resectable pancreatic adenocarcinoma', 'patients with pancreatic adenocarcinoma', 'Pancreatic Cancer Patients', 'Participants with potentially resectable tumors']","['nab-paclitaxel and gemcitabine (PG) alone or with hydroxychloroquine (PGH', 'hydroxychloroquine to preoperative gemcitabine and nab-paclitaxel chemotherapy', 'gemcitabine and nab-paclitaxel', 'Hydroxychloroquine and Gemcitabine/Nab-Paclitaxel', 'autophagy inhibitor hydroxychloroquine', 'Autophagy Inhibition']","['pathological tumor response, improved serum biomarker response, and evidence of autophagy inhibition and immune activity', 'overall and recurrence-free survival', 'serious adverse events', 'markers of autophagy, immune infiltrate, and serum cytokines', 'CA 19-9 serum biomarker response and margin negative R0 resection', 'RFS', 'autophagy inhibition', 'histopathologic response', 'Evans grade histopathologic responses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0072288', 'cui_str': 'Prostaglandin H2'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0004391', 'cui_str': 'Cellular Autophagies'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0004391', 'cui_str': 'Cellular Autophagies'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0201551', 'cui_str': 'CA 199 measurement'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",34.0,0.0657666,"In patients with elevated CA 19-9, a return to normal was associated with improved overall and recurrence-free survival (P < 0.0001).","[{'ForeName': 'Herbert J', 'Initials': 'HJ', 'LastName': 'Zeh', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Bahary', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania. baharyn@upmc.edu.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Boone', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Aatur D', 'Initials': 'AD', 'LastName': 'Singhi', 'Affiliation': 'Department of Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jennifer Lee', 'Initials': 'JL', 'LastName': 'Miller-Ocuin', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Normolle', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Amer H', 'Initials': 'AH', 'LastName': 'Zureikat', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Melissa E', 'Initials': 'ME', 'LastName': 'Hogg', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Bartlett', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kenneth K', 'Initials': 'KK', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Tsung', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'J Wallis', 'Initials': 'JW', 'LastName': 'Marsh', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Pranav', 'Initials': 'P', 'LastName': 'Murthy', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Daolin', 'Initials': 'D', 'LastName': 'Tang', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Seiser', 'Affiliation': ""HPB and Transplant Institute at St. Vincent's Medical Center, Los Angeles, California.""}, {'ForeName': 'Ravi K', 'Initials': 'RK', 'LastName': 'Amaravadi', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Espina', 'Affiliation': 'Center for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, Virginia.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Liotta', 'Affiliation': 'Center for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, Virginia.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Lotze', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-4042']
3157,31994641,Challenges and opportunities in the science of research to practice: lessons learned from a randomized controlled trial of a sexual risk-reduction intervention for psychiatric patients in a public mental health system.,"OBJECTIVE


Human immunodeficiency virus (HIV) prevention efficacy trials with psychiatric patients have been conducted in research settings in high-resourced countries, establishing short-term efficacy for reducing sexual risk behavior. None has been implemented within systems of care. In the last decade, overcoming this research-to-practice gap has become a focus of implementation science. This paper describes the first and only HIV Prevention intervention trial for psychiatric patients conducted in real-world outpatient psychiatric settings facilitated by trained clinic-based providers.
METHODS


The HIV Prevention intervention, which uses the Information-Motivation-Behavioral Skills model to achieve sexual risk-reduction, was rigorously adapted to the local context and clinic services' needs. Participants from eight clinics were randomized to HIV Prevention or Health Promotion conditions.
RESULTS


HIV Prevention participants showed significant improvement in Information-Motivation-Behavioral domains; in this group, behavioral intentions were associated with significantly fewer unprotected sex occasions, but reduction of unprotected sex occasions was similar in both conditions.
CONCLUSION


Our trial was conducted before implementation studies became widely funded. Transporting an intervention to a new culture or into real-world practice settings may require adaptations. Our results demonstrate that clear guidelines are needed regarding whether to conduct efficacy, effectiveness, and/or implementation research as the most appropriate next step.
CLINICAL TRIAL REGISTRATION


NCT00881699.",2020,"RESULTS


HIV Prevention participants showed significant improvement in Information-Motivation-Behavioral domains; in this group, behavioral intentions were associated with significantly fewer unprotected sex occasions, but reduction of unprotected sex occasions was similar in both conditions.
","['psychiatric patients', 'psychiatric patients conducted in real-world outpatient psychiatric settings facilitated by trained clinic-based providers', 'psychiatric patients in a public mental health system', 'Participants from eight clinics']","['HIV Prevention or Health Promotion conditions', 'sexual risk-reduction intervention']","['Information-Motivation-Behavioral domains', 'unprotected sex occasions']","[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0556482', 'cui_str': 'Unsafe Sex'}]",8.0,0.0553892,"RESULTS


HIV Prevention participants showed significant improvement in Information-Motivation-Behavioral domains; in this group, behavioral intentions were associated with significantly fewer unprotected sex occasions, but reduction of unprotected sex occasions was similar in both conditions.
","[{'ForeName': 'Milton L', 'Initials': 'ML', 'LastName': 'Wainberg', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Claudio G', 'Initials': 'CG', 'LastName': 'Mann', 'Affiliation': 'Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Norcini-Pala', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McKinnon', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Pinto', 'Affiliation': 'Universidade Federal do Estado do Rio de Janeiro (UNIRIO), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Pinho', 'Affiliation': 'George Washington University, Washington, DC, USA.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Cavalcanti', 'Affiliation': 'Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Leu', 'Initials': 'L', 'LastName': 'Cheng-Shiun', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Guimarães', 'Affiliation': 'Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Mattos', 'Affiliation': 'Universidade Federal do Rio de Janeiro (UFRJ), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Hughes', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Palinkas', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Otto-Salaj', 'Affiliation': 'University of Wisconsin-Milwaukee, Milwaukee, WI, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Remien', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Cournos', 'Affiliation': 'Columbia University, New York, NY, USA.'}]","Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)",['10.1590/1516-4446-2019-0737']
3158,31714592,Final report of a prospective randomized study on thoracic radiotherapy target volume for limited-stage small cell lung cancer with radiation dosimetric analyses.,"BACKGROUND


The thoracic radiotherapy (TRT) target volume for limited-stage small-cell lung cancer (SCLC) has been controversial for decades. In this report, the final results of a prospective randomized trial on the TRT target volume before and after induction chemotherapy are presented.
METHODS


After 2 cycles of etoposide and cisplatin, patients arm were randomized to receive TRT to the postchemotherapy or prechemotherapy tumor volume in a study arm and a control arm. Involved-field radiotherapy was received in both arms. TRT consisted of 1.5 grays (Gy) twice daily in 30 fractions to up to a total dose of 45 Gy. Lymph node regions were contoured, and intentional and incidental radiation doses were recorded.
RESULTS


The study was halted early because of slow accrual. Between 2002 and 2017, 159 and 150 patients were randomized to the study arm or the control arm, respectively; and 21.4% and 19.1% of patients, respectively, were staged using positron emission tomography/computed tomography (P = .31). With a median follow-up of 54.1 months (range, 19.9-165.0 months) in survivors, the 3-year local/regional progression-free probability was 58.2% and 65.5% in the study and control arms, respectively (P = .44), and the absolute difference was -7.3% (95% CI, -18.2%, 3.7%). In the study and control arms, the median overall survival was 21.9 months and 26.6 months, respectively, and the 5-year overall survival rate was 22.8% and 28.1%, respectively (P = .26). Grade 3 esophagitis was observed in 5.9% of patients in the study arm versus 15.5% of those in the control arm (P = .01). The isolated out-of-field failure rate was 2.6% in the study arm versus 4.1% in the control arm (P = .46), and all such failures were located in the supraclavicular fossa or contralateral hilum. The regions 7, 3P, 4L, 6, 4R, 5, and 2L received incidental radiation doses >30 Gy.
CONCLUSIONS


TRT could be limited to the postchemotherapy tumor volume, and involved-field radiotherapy could be routinely applied for limited-stage SCLC.",2020,"The isolated out-of-field failure rate was 2.6% in the study arm versus 4.1% in the control arm (P = .46), and all such failures were located in the supraclavicular fossa or contralateral hilum.","['limited-stage small-cell lung cancer', 'Between 2002 and 2017, 159 and 150 patients']","['postchemotherapy or prechemotherapy', 'thoracic radiotherapy (TRT', 'TRT', 'positron emission tomography/computed tomography', 'etoposide and cisplatin', 'thoracic radiotherapy']","['median overall survival', '3-year local/regional progression-free probability', '5-year overall survival rate', 'Grade 3 esophagitis']","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0014868', 'cui_str': 'Esophagitis'}]",,0.103374,"The isolated out-of-field failure rate was 2.6% in the study arm versus 4.1% in the control arm (P = .46), and all such failures were located in the supraclavicular fossa or contralateral hilum.","[{'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yu-Jin', 'Initials': 'YJ', 'LastName': 'Xu', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Hui-Neng', 'Initials': 'HN', 'LastName': 'Zhu', 'Affiliation': 'Department of Pathology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jin-Shi', 'Initials': 'JS', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Clinical Trials Center, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Hong-Lian', 'Initials': 'HL', 'LastName': 'Ma', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Xiao-Ling', 'Initials': 'XL', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Zheng-Bo', 'Initials': 'ZB', 'LastName': 'Song', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Hua-Rong', 'Initials': 'HR', 'LastName': 'Tang', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Peng', 'Affiliation': 'Department of Radiation Oncology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Fang', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Kong', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Meng-Yuan', 'Initials': 'MY', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Bai-Qiang', 'Initials': 'BQ', 'LastName': 'Dong', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Pathology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Pathology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Xin-Min', 'Initials': 'XM', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hong', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yi-Ping', 'Initials': 'YP', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Peng-Cheng', 'Initials': 'PC', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'You-Hua', 'Initials': 'YH', 'LastName': 'Jiang', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Xin-Ming', 'Initials': 'XM', 'LastName': 'Zhou', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Qi-Xun', 'Initials': 'QX', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Wen-Yong', 'Initials': 'WY', 'LastName': 'Sun', 'Affiliation': 'Department of Pathology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Wei-Min', 'Initials': 'WM', 'LastName': 'Mao', 'Affiliation': 'Department of Thoracic Surgery, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, Institute of Cancer Research and Basic Medical Sciences and University Cancer Hospital, Chinese Academy of Sciences, Zhejiang Cancer Hospital, Zhejiang Provincial Key Laboratory of Radiation Oncology, Hangzhou, China.'}]",Cancer,['10.1002/cncr.32586']
3159,31998949,"Surface Perturbation Training to Prevent Falls in Older Adults: A Highly Pragmatic, Randomized Controlled Trial.","BACKGROUND


Falls are the leading cause of injuries among older adults, and trips and slips are major contributors to falls.
OBJECTIVE


The authors sought to compare the effectiveness of adding a component of surface perturbation training to usual gait/balance training for reducing falls and fall-related injury in high-risk older adults referred to physical therapy.
DESIGN


This was a multi-center, pragmatic, randomized, comparative effectiveness trial.
SETTING


Treatment took place within 8 outpatient physical therapy clinics.
PATIENTS


This study included 506 patients 65+ years of age at high fall risk referred for gait/balance training.
INTERVENTION


This trial evaluated surface perturbation treadmill training integrated into usual multimodal exercise-based balance training at the therapist's discretion versus usual multimodal exercise-based balance training alone.
MEASUREMENTS


Falls and injurious falls were assessed with a prospective daily fall diary, which was reviewed via telephone interview every 3 months for 1 year.A total of 211/253 (83%) patients randomized to perturbation training and 210/253 (83%) randomized to usual treatment provided data at 3-month follow-up. At 3 months, the perturbation training group had a significantly reduced chance of fall-related injury (5.7% versus 13.3%; relative risk 0.43) but no significant reduction in the risk of any fall (28% versus 37%, relative risk 0.78) compared with usual treatment. Time to first injurious fall showed reduced hazard in the first 3 months but no significant reduction when viewed over the entire first year.
LIMITATIONS


The limitations of this trial included lack of blinding and variable application of interventions across patients based on pragmatic study design.
CONCLUSION


The addition of some surface perturbation training to usual physical therapy significantly reduced injurious falls up to 3 months posttreatment. Further study is warranted to determine the optimal frequency, dose, progression, and duration of surface perturbation aimed at training postural responses for this population.",2020,"At 3 months, the perturbation-training group had significantly reduced chance of fall-related injury (5.7% vs. 13.3%; relative risk 0.43, p < 0.01) but no significant reduction in the risk of any fall (28% vs. 37% ST; relative risk 0.78 p<0.07) compared to usual treatment.","['high-risk older adults', 'Older Adults', 'Treatment took place within 8 outpatient physical therapy clinics', '506 patients aged 65+ at high fall risk referred for gait/balance training']","['surface-perturbation training to usual gait/balance training', 'Surface Perturbation Training', ""usual multimodal exercise-based balance training at the therapist's discretion versus usual multimodal exercise-based balance training alone""]","['injurious falls', 'Falls and injurious falls', 'chance of fall-related injury']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",506.0,0.0271618,"At 3 months, the perturbation-training group had significantly reduced chance of fall-related injury (5.7% vs. 13.3%; relative risk 0.43, p < 0.01) but no significant reduction in the risk of any fall (28% vs. 37% ST; relative risk 0.78 p<0.07) compared to usual treatment.","[{'ForeName': 'Jon D', 'Initials': 'JD', 'LastName': 'Lurie', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, One Medical Center Dr, Lebanon, NH 03781 (USA), and Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Zagaria', 'Affiliation': 'Geisel School of Medicine at Dartmouth.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Ellis', 'Affiliation': 'Elliot Hospital Senior Health Center Rehabilitation, Manchester, New Hampshire.'}, {'ForeName': 'Dawna', 'Initials': 'D', 'LastName': 'Pidgeon', 'Affiliation': 'Dartmouth-Hitchcock Medical Center.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Gill-Body', 'Affiliation': 'Newton-Wellesley Hospital, Newton, Massachusetts. Dr Gill-Body is a board-certified clinical specialist in neurologic physical therapy.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Burke', 'Affiliation': 'South Shore Neurologic Associates, Patchogue, New York. Dr Burke is a board-certified clinical specialist in neurologic physical therapy.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Armbrust', 'Affiliation': 'White River Junction Veterans Administration Hospital, White River Junction, Vermont.'}, {'ForeName': 'Sharil', 'Initials': 'S', 'LastName': 'Cass', 'Affiliation': 'Farnum Rehabilitation Center, Keene, New Hampshire.'}, {'ForeName': 'Kevin F', 'Initials': 'KF', 'LastName': 'Spratt', 'Affiliation': 'Geisel School of Medicine at Dartmouth.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'McDonough', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",Physical therapy,['10.1093/ptj/pzaa023']
3160,31959202,Effects of a commercially available branched-chain amino acid-alanine-carbohydrate-based sports supplement on perceived exertion and performance in high intensity endurance cycling tests.,"BACKGROUND


Sports nutritional supplements containing branched-chain amino acids (BCAA) have been widely reported to improve psychological and biological aspects connected to central fatigue and performance in endurance exercise, although the topic is still open to debate. The aim of the present study was to determine whether the intake of a commercially available BCAA-based supplement, taken according to the manufacturer's recommendations, could affect the rating of perceived exertion (RPE) and performance indexes at the beginning (1d) and end of a 9-week (9w) scheduled high intensity interval training program, with an experimental approach integrating the determination of psychometric, performance, metabolic and blood biochemical parameters.
METHODS


This was a randomized double-blind placebo-controlled study. Thirty-two untrained, healthy young adults (20 males and 12 female) were enrolled. A high-intensity endurance cycling (HIEC) test was used to induce fatigue in the participants: HIEC consisted in ten 90 s sprints interspersed by ten 3 min recovery phases and followed by a final step time to exhaustion was used. In parallel with RPE, haematological values (creatine kinase, alanine, BCAA, tryptophan, ammonia and glucose levels), and performance indexes (maximal oxygen consumption - VO 2max , power associated with lactate thresholds - W LT1 , W LT2  and time to exhaustion - TTE) were assessed. All subject took the supplement (13.2 g of carbohydrates; 3.2 g of BCAA and 1.6 g of L-alanine per dose) or placebo before each test and training session. Dietary habits and training load were monitored during the entire training period.
RESULTS


The administration of the supplement (SU) at 1d reduced RPE by 9% during the recovery phase, as compared to the placebo (PL); at 9w the RPE scores were reduced by 13 and 21% during the sprint and recovery phase, respectively; at 9w, prolonged supplement intake also improved TTE and TRIMP. SU intake invariably promoted a rapid increase (within 1 h) of BCAA serum blood levels and prevented the post-HIEC tryptophan: BCAA ratio increase found in the PL group, at both 1d and 9w. There was no difference in dietary habits between groups and those habits did not change over time; no difference in glycemia was found between SU and PL. VO 2max , W LT1  and W LT2  values improved over time, but were unaffected by supplement intake.
CONCLUSIONS


On the whole, these results suggest that i) the intake of the BCAA-based commercially available supplement used in this study reduces RPE as a likely consequence of an improvement in the serum tryptophan: BCAA ratio; ii) over time, reduced RPE allows subjects to sustain higher workloads, leading to increased TRIMP and TTE.",2020,There was no difference in dietary habits between groups and those habits did not change over time; no difference in glycemia was found between SU and PL.,"['Thirty-two untrained, healthy young adults (20 males and 12 female']","['placebo', 'Sports nutritional supplements containing branched-chain amino acids (BCAA', 'commercially available branched-chain amino acid-alanine-carbohydrate-based sports supplement']","['VO 2max , W LT1  and W LT2  values', 'glycemia', 'dietary habits', 'SU intake', 'TTE and TRIMP', 'post-HIEC tryptophan: BCAA ratio increase', 'haematological values (creatine kinase, alanine, BCAA, tryptophan, ammonia and glucose levels), and performance indexes (maximal oxygen consumption - VO 2max , power associated with lactate thresholds - W LT1 , W LT2  and time to exhaustion - TTE', 'BCAA serum blood levels', 'serum tryptophan', 'rating of perceived exertion (RPE) and performance indexes']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0002521', 'cui_str': 'Amino Acids, Branched-Chain'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001898', 'cui_str': 'L-alanine'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038039', 'cui_str': 'Sports'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0086152', 'cui_str': 'Diet Habits'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0001898', 'cui_str': 'L-alanine'}, {'cui': 'C0002607', 'cui_str': 'Ammonia'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}]",32.0,0.0937133,There was no difference in dietary habits between groups and those habits did not change over time; no difference in glycemia was found between SU and PL.,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Gervasi', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Sisti', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Amatori', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Donati Zeppa', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Giosuè', 'Initials': 'G', 'LastName': 'Annibalini', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Piccoli', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Vallorani', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Benelli', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Marco B L', 'Initials': 'MBL', 'LastName': 'Rocchi', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Barbieri', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Calavalle', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Agostini', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Carmela', 'Initials': 'C', 'LastName': 'Fimognari', 'Affiliation': 'Department for Life Quality Studies, Alma Mater Studiorum, University of Bologna, Rimini, Italy.'}, {'ForeName': 'Vilberto', 'Initials': 'V', 'LastName': 'Stocchi', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Sestili', 'Affiliation': 'Department of Biomolecular Sciences, University of Urbino Carlo Bo, Urbino, Italy. piero.sestili@uniurb.it.'}]",Journal of the International Society of Sports Nutrition,['10.1186/s12970-020-0337-0']
3161,31667584,Feasibility of ultrasound-guided lumbar epidural access using paramedian transverse scanning with the needle in-plane: a comparison with paramedian sagittal scanning.,"BACKGROUND AND OBJECTIVES


The present study was designed to compare the feasibility of ultrasound (US)-guided lumbar epidural access using paramedian sagittal scanning (PMSS) and paramedian transverse scanning (PMTS) approaches.
METHODS


Fifty patients undergoing surgery of the lower extremities were randomly allocated into 2 groups. The patients in PMSS group received PMSS-guided in-plane epidural access, whereas patients in PMTS group received PMTS-guided in-plane epidural access. The US visibility of neuraxial structures and of Tuohy needle during US scout scan, procedure duration, the number of attempts to access epidural space, Tuohy needle puncture depth in the epidural space, and extent of sensory block after spinal block between two groups were compared.
RESULTS


The US visibility of Tuohy needle and neuraxial structures was comparable between two groups. There was an overall decrease in procedure duration in the PMTS group relative to the PMSS group (360 ± 42 vs. 490 ± 38 s). The number of attempts needed to access the epidural space in PMSS group was significantly higher than in PMTS group. Distances between the epidural space and the puncture site in PMSS group and PMTS group showed a significant difference (7.13 ± 0.67 vs. 5.24 ± 0.21 cm). No significant differences in the extent of sensory block after spinal block were observed.
CONCLUSIONS


We found that PMTS approach was superior as a means of achieving epidural access relative to the PMSS approach, since PMTS approach can be conducted more quickly given shorter path of the needle and less times needed for epidural access during this procedure.
CLINICAL TRIAL REGISTRATION


Chinese Clinical Trial Registry, clinical trial number ChiCTR1800015815, date of registration April 24, 2018.",2020,The US visibility of Tuohy needle and neuraxial structures was comparable between two groups.,['Fifty patients undergoing surgery of the lower extremities'],"['paramedian sagittal scanning', 'PMSS', 'paramedian transverse scanning', 'ultrasound (US)-guided lumbar epidural access using paramedian sagittal scanning (PMSS) and paramedian transverse scanning (PMTS', 'PMTS-guided in-plane epidural access', 'ultrasound-guided lumbar epidural access', 'PMSS-guided in-plane epidural access']","['sensory block after spinal block', 'number of attempts needed to access the epidural space', 'procedure duration', 'US visibility of Tuohy needle and neuraxial structures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0441993', 'cui_str': 'Paramedian approach (qualifier value)'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0228134', 'cui_str': 'Epidural Space'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0184186', 'cui_str': 'Tuohy epidural needle'}]",50.0,0.0479317,The US visibility of Tuohy needle and neuraxial structures was comparable between two groups.,"[{'ForeName': 'Huili', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, No. 8, Gongtinan Road, Chaoyang District, Beijing, 100020, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Kang', 'Affiliation': 'Department of Pharmaceutical Science, Beijing Chaoyang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology, Miyun Hospital, Beijing, China.'}, {'ForeName': 'Danxu', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, No. 8, Gongtinan Road, Chaoyang District, Beijing, 100020, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, No. 8, Gongtinan Road, Chaoyang District, Beijing, 100020, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Chaoyang Hospital, Capital Medical University, No. 8, Gongtinan Road, Chaoyang District, Beijing, 100020, China. wangyun129@ccmu.edu.cn.'}]",Journal of anesthesia,['10.1007/s00540-019-02704-7']
3162,32139762,Exercise intensity and physical fitness modulate lipoproteins profile during acute aerobic exercise session.,"Physical inactivity has emerged as an important cardiometabolic risk factor; however, the beneficial impacts of physical exercise according physical fitness status are still unclear. To analyze the lipoproteins and immune-endocrine response to acute aerobic exercise sessions performed at different intensities according physical fitness status and evaluated the gene expression in monocyte cells. Twelve individuals, divided into Low and High VO 2max,  performed three randomized acute exercise sessions at low (<60% VO 2max ), moderate (60-75% VO 2max ), and high (>90% VO 2max ) intensities. Blood samples were collected pre, immediately post, and 60 minutes post-exercise to analyze NEFA, triacylglycerol, non-HDL-c, HDL-c, PAI-1, leptin and adiponectin concentrations. Blood samples were collected from another set of twelve individuals for use in monocyte cell cultures to analyze L-CAT, CETP, and AMPK gene expressions. Low VO 2max  group pre-exercise exhibited higher postprandial leptin and total cholesterol concentrations than High VO 2max  group (p < 0.05). Exercise performed in high-intensity promoted a decreased leptin and NEFA levels (p < 0.05, for both), but for PAI-1 levels was decreased (p < 0.05) only for the Low VO 2max  group. Triacylglycerol levels decreased after all exercise sessions (p < 0.05) for both groups, and HDL-c exhibited decrease during moderate-intensity (p < 0.05), but this scenario was attenuated in Low VO 2max  group. Low VO 2max  individuals exhibit some metabolic-endocrine disruption, and acute aerobic exercise sessions performed at low, moderate, and high intensities are capable of modulating metabolic-endocrine parameters, mainly at high-intensity, in a physical fitness-dependent way, given that Low VO 2max  group was more responsive and seem to be able to appropriate more exercise-related benefits.",2020,"Exercise performed in high-intensity promoted a decreased leptin and NEFA levels (p < 0.05, for both), but for PAI-1 levels was decreased (p < 0.05) only for the Low VO 2max  group.","['Twelve individuals, divided into Low and High VO 2max,  performed three randomized']","['acute exercise sessions', 'acute aerobic exercise sessions', 'acute aerobic exercise session']","['moderate-intensity', 'PAI-1 levels', 'leptin and NEFA levels', 'postprandial leptin and total cholesterol concentrations', 'Triacylglycerol levels']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",,0.0139516,"Exercise performed in high-intensity promoted a decreased leptin and NEFA levels (p < 0.05, for both), but for PAI-1 levels was decreased (p < 0.05) only for the Low VO 2max  group.","[{'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Antunes', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Movement Sciences, Department of Physical Education, São Paulo State University (UNESP), Presidente Prudente, SP, Brazil. ba.antunes2@gmail.com.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Rossi', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Movement Sciences, Department of Physical Education, São Paulo State University (UNESP), Presidente Prudente, SP, Brazil.'}, {'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Oyama', 'Affiliation': 'Universidade Federal de São Paulo, Escola Paulista de Medicina, Departamento de Fisiologia, São Paulo, Brazil.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Rosa-Neto', 'Affiliation': 'Immunometabolism Research Group, Department of Cell Biology and Development, Institute of Biomeical Science of University of São Paulo (USP), São Paulo, Brazil.'}, {'ForeName': 'F S', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Post-Graduation Program in Movement Sciences, Department of Physical Education, São Paulo State University (UNESP), Presidente Prudente, SP, Brazil.'}]",Scientific reports,['10.1038/s41598-020-61039-6']
3163,31230661,Post-colposcopy Management of ASC-US and LSIL Pap Tests (PALS Trial): Pilot RCT.,"OBJECTIVE


Evidence supporting optimal follow-up of women with atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion cytology found to have low-grade disease or normal findings at initial colposcopy is weak. Surveillance options include continued colposcopy, discharge with Pap testing, or HPV testing at 12 months. This study was a pilot RCT comparing these three follow-up policies. The objectives were to determine the feasibility of an RCT and to compare the incidence of greater than or equal to high-grade squamous intraepithelial lesion (≥HSIL) in each of the follow-up policies.
METHODS


A total of 133 women referred with ASC-US or low-grade squamous intraepithelial lesion cytology between June and August 2012 underwent initial colposcopy where incident ≥HSIL histology was ruled out. Of these women, 125 were randomly assigned to colposcopic surveillance, Pap testing, or HPV testing. Patients with high-risk results at any point were treated according to standard of care. Patient recruitment and adherence to follow-up were calculated using descriptive statistics. Accuracy of the three follow-up arms was calculated (Canadian Task Force Classification: IC).
RESULTS


Recruitment rates were 80%, and adherence to protocol was 85% to 100%. Nine of 125 (7.2%) patients overall were found to have ≥HSIL histology at exit: one of 43 in the reference colposcopy group, and six of 41 and three of 41 in Pap and HPV arms, respectively. One early cancer was detected in the HPV arm. Sensitivity and specificity (CI) for each arm, respectively, were as follows: colposcopy N/A, 100% (88.1%-100%); Pap, 100% (47.8%-100%) and 85.7% (63.7%-97%); and HPV, 66.7% (9.4%-99.2%) and 68% (46.5%-85.1%).
CONCLUSION


This pilot study demonstrated the operational and safety feasibility of an RCT in this patient population. Validation of clinical findings is necessary.",2019,"Nine of 125 (7.2%) patients overall were found to have ≥HSIL histology at exit: one of 43 in the reference colposcopy group, and six of 41 and three of 41 in Pap and HPV arms, respectively.","['133 women referred with ASC-US or low-grade squamous intraepithelial lesion cytology between June and August 2012 underwent initial colposcopy where incident ≥HSIL histology was ruled out', 'women with atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion cytology', 'patient population', 'Patients with high-risk results at any point were treated according to standard of care']","['RCT', 'colposcopic surveillance, Pap testing, or HPV testing']",['Sensitivity and specificity (CI'],"[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1302773', 'cui_str': 'Low-Grade Squamous Intraepithelial Lesions'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0009417', 'cui_str': 'Colposcopy'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0521184', 'cui_str': 'ASCUS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}]",133.0,0.0981165,"Nine of 125 (7.2%) patients overall were found to have ≥HSIL histology at exit: one of 43 in the reference colposcopy group, and six of 41 and three of 41 in Pap and HPV arms, respectively.","[{'ForeName': 'Lana', 'Initials': 'L', 'LastName': 'Saciragic', 'Affiliation': 'Section of Gynecologic Oncology, Department of Obstetrics & Gynecology, University of Calgary, Tom Baker Cancer Centre, Calgary, AB.'}, {'ForeName': 'Gregg', 'Initials': 'G', 'LastName': 'Nelson', 'Affiliation': 'Section of Gynecologic Oncology, Department of Obstetrics & Gynecology, University of Calgary, Tom Baker Cancer Centre, Calgary, AB. Electronic address: gregg.nelson@albertahealthservices.ca.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Chiarella-Redfern', 'Affiliation': 'Cumming School of Medicine, Health Sciences Centre, University of Calgary, AB.'}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Kanarek', 'Affiliation': 'Department of Environmental Health and\xa0Engineering, Johns Hopkins School of Public Health, Baltimore, MD.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Nation', 'Affiliation': 'Section of Gynecologic Oncology, Department of Obstetrics & Gynecology, University of Calgary, Tom Baker Cancer Centre, Calgary, AB.'}, {'ForeName': 'Máire A', 'Initials': 'MA', 'LastName': 'Duggan', 'Affiliation': 'Department of Pathology and Laboratory Medicine, Cumming School of Medicine, University of Calgary, Foothills Medical Centre, Calgary, AB.'}]",Journal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC,['10.1016/j.jogc.2018.08.004']
3164,31558480,Randomized Phase II Trial and Tumor Mutational Spectrum Analysis from Cabozantinib versus Chemotherapy in Metastatic Uveal Melanoma (Alliance A091201).,"PURPOSE


The surface receptor MET is highly expressed on primary uveal melanoma; MET inhibitors demonstrated early clinical signals of efficacy in slowing uveal melanoma growth. The primary objective of our study was to compare the progression-free survival rate at 4 months (PFS4) of patients with uveal melanoma treated with cabozantinib or chemotherapy.
PATIENTS AND METHODS


Patients with metastatic uveal melanoma and RECIST measurable disease were randomized 2:1 to receive either cabozantinib (arm 1) versus temozolomide or dacarbazine (arm 2) with restaging imaging every two cycles. Cross-over from arm 2 to cabozantinib after progression was allowed (arm 2X). Available tumor specimens were analyzed by whole-exome sequencing (WES) and results were correlated with outcome.
RESULTS


Forty-six eligible patients were accrued with 31, 15, and 9 in arms 1, 2, and 2X, respectively. Median lines of prior therapy, including hepatic embolization, were two. Rates of PFS4 in arm 1 and arm 2 were 32.3% and 26.7% ( P  = 0.35), respectively, with median PFS time of 60 and 59 days ( P  = 0.964; HR = 0.99). Median overall survival (OS) was 6.4 months and 7.3 months ( P  = 0.580; HR = 1.21), respectively. Grade 3-4 Common Terminology Criteria for Adverse Events were present in 61.3%, 46.7%, and 37.5% in arms 1, 2, and 2X, respectively. WES demonstrated a mean tumor mutational burden of 1.53 mutations/Mb and did not separate OS ≤ or >1 year ( P  = 0.14). Known mutations were identified by WES and novel mutations were nominated.
CONCLUSIONS


MET/VEGFR blockade with cabozantinib demonstrated no improvement in PFS but an increase in toxicity relative to temozolomide/dacarbazine in metastatic uveal melanoma.",2020,"Median overall survival was 6.4 months and 7.3 months (p=0.580; HR=1.21), respectively.","['Forty-six eligible patients', 'patients with UM treated with cabozantinib or chemotherapy', 'metastatic uveal melanoma (Alliance A091201', 'Patients with metastatic UM and RECIST measurable disease']","['temozolomide/dacarbazine', 'cabozantinib versus chemotherapy', 'cabozantinib', 'temozolomide or dacarbazine']","['CTCAE adverse events', 'Rates of PFS4', 'mean tumor mutational burden', 'median PFS time', 'Median overall survival', 'PFS', 'progression-free survival rate', 'toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0220633', 'cui_str': 'Uveal melanoma'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C3181682', 'cui_str': 'cabozantinib'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",46.0,0.163087,"Median overall survival was 6.4 months and 7.3 months (p=0.580; HR=1.21), respectively.","[{'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Luke', 'Affiliation': 'University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. lukejj@upmc.edu.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Olson', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'Jacob B', 'Initials': 'JB', 'LastName': 'Allred', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Strand', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Riyue', 'Initials': 'R', 'LastName': 'Bao', 'Affiliation': 'Center for Research Informatics, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Zha', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Carll', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Labadie', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, Illinois.'}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'Bastos', 'Affiliation': 'Miami Cancer Institute-Baptist Health South Florida, Miami, Florida.'}, {'ForeName': 'Marcus O', 'Initials': 'MO', 'LastName': 'Butler', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hogg', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Pamela N', 'Initials': 'PN', 'LastName': 'Munster', 'Affiliation': 'University of California at San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Gary K', 'Initials': 'GK', 'LastName': 'Schwartz', 'Affiliation': 'Columbia University Herbert Irving Comprehensive Cancer Center, New York, New York.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-1223']
3165,32199491,"Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in adults in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial.","BACKGROUND


The 2014 Zaire Ebola virus disease epidemic accelerated vaccine development for the virus. We aimed to assess the safety, reactogenicity, and immunogenicity of one dose of monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z) in adults.
METHODS


This phase 2, randomised, observer-blind, controlled trial was done in study centres in Cameroon, Mali, Nigeria, and Senegal. Healthy adults (≥18 years) were randomly assigned with a web-based system (1:1; minimisation procedure accounting for age, gender, centre) to receive ChAd3-EBO-Z (day 0), or saline placebo (day 0) and ChAd3-EBO-Z (month 6). The study was observer-blind until planned interim day 30 analysis, single-blind until month 6, and open-label after month 6 vaccination. Primary outcomes assessed in the total vaccinated cohort, which comprised all participants with at least one study dose administration documented, were serious adverse events (up to study end, month 12); and for a subcohort were solicited local or general adverse events (7 days post-vaccination), unsolicited adverse events (30 days post-vaccination), haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia (day 0-6). Secondary endpoints (subcohort; per-protocol cohort) evaluated anti-glycoprotein Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination. This study is registered with ClinicalTrials.gov, NCT02485301.
FINDINGS


Between July 22, 2015, and Dec 10, 2015, 3030 adults were randomly assigned; 3013 were included in the total vaccinated cohort (1509 [50·1%] in the ChAd3-EBO-Z group and 1504 [49·9%] in the placebo/ChAd3-EBO-Z group), 17 were excluded because no vaccine was administered. The most common solicited injection site symptom was pain (356 [48%] of 748 in the ChAd3-EBO-Z group vs 57 [8%] of 751 in the placebo/ChAd3-EBO-Z group); the most common solicited general adverse event was headache (345 [46%] in the ChAd3-EBO-Z group vs 136 [18%] in the placebo/ChAd3-EBO-Z group). Unsolicited adverse events were reported by 123 (16%) of 749 in the ChAd3-EBO-Z group and 119 (16%) of 751 in the placebo/ChAd3-EBO-Z group. Serious adverse events were reported for 11 (1%) of 1509 adults in the ChAd3-EBO-Z group, and 18 (1%) of 1504 in the placebo/ChAd3-EBO-Z group; none were considered vaccination-related. No clinically meaningful thrombocytopenia was reported. At day 30, anti-glycoprotein Ebola virus antibody geometric mean concentration was 900 (95% CI 824-983) in the ChAd3-EBO-Z group. There were no treatment-related deaths.
INTERPRETATION


ChAd3-EBO-Z was immunogenic and well tolerated in adults. Our findings provide a strong basis for future development steps, which should concentrate on multivalent approaches (including Sudan and Marburg strains). Additionally, prime-boost approaches should be a focus with a ChAd3-based vaccine for priming and boosted by a modified vaccinia Ankara-based vaccine.
FUNDING


EU's Horizon 2020 research and innovation programme and GlaxoSmithKline Biologicals SA.",2020,"Serious adverse events were reported for 11 (1%) of 1509 adults in the ChAd3-EBO-Z group, and 18 (1%) of 1504 in the placebo/ChAd3-EBO-Z group;","['adults in Africa', 'adults', 'Healthy adults (≥18 years', 'study centres in Cameroon, Mali, Nigeria, and Senegal', 'Between July 22, 2015, and Dec 10, 2015, 3030 adults were randomly assigned; 3013 were included in the total vaccinated cohort (1509 [50·1%] in the ChAd3-EBO-Z group and 1504']","['placebo', 'monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z', 'chimpanzee adenovirus vectored Ebola vaccine', 'ChAd3-EBO-Z (day 0), or saline placebo']","['unsolicited adverse events', 'solicited local or general adverse events', 'Serious adverse events', 'meaningful thrombocytopenia', 'Safety, reactogenicity, and immunogenicity', 'serious adverse events', 'Unsolicited adverse events', 'safety, reactogenicity, and immunogenicity', 'Secondary endpoints (subcohort; per-protocol cohort) evaluated anti-glycoprotein Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination', 'haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia', 'headache']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006802', 'cui_str': 'Republic of Cameron'}, {'cui': 'C0024581', 'cui_str': 'Republic of Mali'}, {'cui': 'C0028075', 'cui_str': 'Federal Republic of Nigeria'}, {'cui': 'C0036644', 'cui_str': 'Republic of Senegal'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0001483', 'cui_str': 'Adenoviruses'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1449556', 'cui_str': 'Ebola Vaccines'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0486729', 'cui_str': 'Ebola virus antibody'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}]",3030.0,0.541374,"Serious adverse events were reported for 11 (1%) of 1509 adults in the ChAd3-EBO-Z group, and 18 (1%) of 1504 in the placebo/ChAd3-EBO-Z group;","[{'ForeName': 'Milagritos D', 'Initials': 'MD', 'LastName': 'Tapia', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: mtapia@som.umaryland.edu.'}, {'ForeName': 'Samba O', 'Initials': 'SO', 'LastName': 'Sow', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'Birahim P', 'Initials': 'BP', 'LastName': 'Ndiaye', 'Affiliation': 'Le Dantec Laboratory of Bacteriology and Virology, Dakar, Senegal; Institut de Recherche en Santé, de Surveillance Epidemiologique et de Formations, Dakar, Senegal.'}, {'ForeName': 'Khardiata D', 'Initials': 'KD', 'LastName': 'Mbaye', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Sénégal.'}, {'ForeName': 'Aliou', 'Initials': 'A', 'LastName': 'Thiongane', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Sénégal.'}, {'ForeName': 'Cheikh T', 'Initials': 'CT', 'LastName': 'Ndour', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Sénégal.'}, {'ForeName': 'Souleymane', 'Initials': 'S', 'LastName': 'Mboup', 'Affiliation': 'Le Dantec Laboratory of Bacteriology and Virology, Dakar, Senegal; Institut de Recherche en Santé, de Surveillance Epidemiologique et de Formations, Dakar, Senegal.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Ake', 'Affiliation': 'US Military HIV Research Program, Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Babajide', 'Initials': 'B', 'LastName': 'Keshinro', 'Affiliation': 'Walter Reed Program, Abuja, Nigeria.'}, {'ForeName': 'Gideon A', 'Initials': 'GA', 'LastName': 'Akintunde', 'Affiliation': 'Walter Reed Program, Abuja, Nigeria.'}, {'ForeName': 'Thompson N', 'Initials': 'TN', 'LastName': 'Kinge', 'Affiliation': 'Bamenda Regional Hospital, Bamenda, Cameroon.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Vernet', 'Affiliation': 'Centre Pasteur du Cameroun, Yaounde, Cameroon.'}, {'ForeName': 'Jean Joel', 'Initials': 'JJ', 'LastName': 'Bigna', 'Affiliation': 'Centre Pasteur du Cameroun, Yaounde, Cameroon.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Oguche', 'Affiliation': 'University of Jos & Jos University Teaching Hospital, Jos, Nigeria.'}, {'ForeName': 'Kwadwo A', 'Initials': 'KA', 'LastName': 'Koram', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Kwaku P', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Wayne R', 'Initials': 'WR', 'LastName': 'Hogrefe', 'Affiliation': 'Q(2) Solutions, San Juan Capistrano, CA, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Günther', 'Affiliation': 'Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.'}, {'ForeName': 'Abdi', 'Initials': 'A', 'LastName': 'Naficy', 'Affiliation': 'Quintiles, La Défense Cedex, France.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'De Ryck', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Debois', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bourguignon', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jongert', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Ballou', 'Affiliation': 'GSK, Rockville, MD, USA.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Koutsoukos', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roman', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30016-5']
3166,32199492,"Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in children in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial.","BACKGROUND


During the large 2013-16 Ebola virus outbreak caused by the Zaire Ebola virus, about 20% of cases were reported in children. This study is the first, to our knowledge, to evaluate an Ebola vaccine in children younger than 6 years. We aimed to evaluate the safety, reactogenicity, and immunogenicity of a monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z) in a paediatric population.
METHODS


This phase 2, randomised, observer-blind, controlled trial was done in a vaccine centre in Mali and a university hospital centre in Senegal. Healthy children were randomly assigned through a web-based system (1:1; stratified by age group, gender, and centre) to receive ChAd3-EBO-Z (day 0) and meningococcal serogroups A,C,W-135,Y tetanus toxoid conjugate vaccine (MenACWY-TT; month 6), or MenACWY-TT (day 0) and ChAd3-EBO-Z (month 6). The study was observer-blind from study start until interim day 30 analysis and became single-blind as of interim analysis. Primary outcomes assessed were serious adverse events (up to study end, month 12), solicited local or general adverse events (7 days post-vaccination), unsolicited adverse events (30 days post-vaccination), haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia (day 0-6). As secondary endpoints, we evaluated anti-glycoprotein Zaire Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination. This study is registered with ClinicalTrials.gov, NCT02548078.
FINDINGS


From Nov 11, 2015, to May 9, 2016, of 776 children screened for eligibility, 600 were randomly assigned (200 [33%] in each age strata: 1-5, 6-12, 13-17 years), 300 (50%) to the ChAd3-EBO-Z/MenACWY-TT group and 300 (50%) to the MenACWY-TT/ChAd3-EBO-Z group; all were included in the total vaccinated cohort. Post-day 0 vaccination, the most common solicited injection site symptom was pain (127 [42%] of 300 in the ChAd3-EBO-Z/MenACWY-TT group vs 60 [20%] of 300 in the MenACWY-TT/ChAd3-EBO-Z group); the most common solicited general adverse event was fever (95 [32%] of 300 in the ChAd3-EBO-Z/MenACWY-TT group vs 28 [9%] of 300 in the MenACWY-TT/ChAd3-EBO-Z group). Unsolicited adverse events post-day 0 vaccination were reported by 41 (14%) of 300 participants in the ChAd3-EBO-Z/MenACWY-TT group and 24 (8%) of 300 MenACWY-TT/ChAd3-EBO-Z recipients. Serious adverse events were reported for two (1%) of 300 children in each group; none were considered vaccination related. No clinical symptoms of thrombocytopenia were reported. At day 30, anti-glycoprotein Ebola virus antibody geometric mean concentrations (GMC) in the ChAd3-EBO-Z/MenACWY-TT group were 1564 (95% CI 1340-1826) for those aged 13-17 years, 1395 (1175-1655) for 6-12 years, and 2406 (1942-2979) for 1-5 years. Anti-glycoprotein Ebola virus IgG antibody responses persisted up to 12 months post-vaccination, with a GMC of 716 (95% CI 619-828) for those aged 13-17 years, 752 (645-876) for 6-12 years, and 1424 (1119-1814) for 1-5 years.
INTERPRETATION


ChAd3-EBO-Z was immunogenic and well tolerated in children aged 1-17 years. This study provides the first ChAd3-EBO-Z data in a paediatric population. Further development should focus on multivalent approaches including Sudan and Marburg strains, and heterologous prime-boost strategies, for instance using modified vaccinia Ankara-based vaccine to boost the immune response.
FUNDING


EU's Horizon 2020 research and innovation programme and GlaxoSmithKline Biologicals SA.",2020,Serious adverse events were reported for two (1%) of 300 children in each group; none were considered vaccination related.,"['vaccine centre in Mali and a university hospital centre in Senegal', 'Healthy children', 'children younger than 6 years', 'children in Africa', 'children aged 1-17 years', 'paediatric population', '776 children screened for eligibility, 600 were randomly assigned (200 [33%] in each age strata: 1-5, 6-12, 13-17 years), 300 (50%) to the']","['ChAd3-EBO-Z (day 0) and meningococcal serogroups A,C,W-135,Y tetanus toxoid conjugate vaccine (MenACWY-TT; month 6), or MenACWY-TT', 'ChAd3-EBO-Z/MenACWY-TT', 'placebo', 'monovalent, recombinant, chimpanzee adenovirus type-3 vectored Zaire Ebola glycoprotein vaccine (ChAd3-EBO-Z', 'chimpanzee adenovirus vectored Ebola vaccine', 'Ebola vaccine']","['clinical symptoms of thrombocytopenia', 'solicited local or general adverse events (7 days post-vaccination), unsolicited adverse events (30 days post-vaccination), haematological or biochemical abnormalities, and clinical symptoms of thrombocytopenia', 'Serious adverse events', 'Safety, reactogenicity, and immunogenicity', 'serious adverse events', 'safety, reactogenicity, and immunogenicity', 'anti-glycoprotein Zaire Ebola virus antibody titres (ELISA) pre-vaccination and 30 days post-vaccination']","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0024581', 'cui_str': 'Republic of Mali'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0036644', 'cui_str': 'Republic of Senegal'}, {'cui': 'C0686744', 'cui_str': 'Well child (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0449543', 'cui_str': 'Serogroup'}, {'cui': 'C0305062', 'cui_str': 'Clostridium tetani toxoid antigen, inactivated'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C3529849', 'cui_str': 'tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}, {'cui': 'C0001483', 'cui_str': 'Adenoviruses'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1449556', 'cui_str': 'Ebola Vaccines'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0949896', 'cui_str': 'Zaire Ebola Virus'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",,0.236911,Serious adverse events were reported for two (1%) of 300 children in each group; none were considered vaccination related.,"[{'ForeName': 'Milagritos D', 'Initials': 'MD', 'LastName': 'Tapia', 'Affiliation': 'Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, MD, USA. Electronic address: mtapia@som.umaryland.edu.'}, {'ForeName': 'Samba O', 'Initials': 'SO', 'LastName': 'Sow', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'Khardiata D', 'Initials': 'KD', 'LastName': 'Mbaye', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Senegal.'}, {'ForeName': 'Aliou', 'Initials': 'A', 'LastName': 'Thiongane', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Senegal.'}, {'ForeName': 'Birahim P', 'Initials': 'BP', 'LastName': 'Ndiaye', 'Affiliation': 'Le Dantec Laboratory of Bacteriology and Virology, Dakar, Senegal; Institut de Recherche en Santé, de Surveillance Epidemiologique et de Formations, Dakar, Senegal.'}, {'ForeName': 'Cheikh T', 'Initials': 'CT', 'LastName': 'Ndour', 'Affiliation': 'University Cheikh Anta Diop, Dakar, Senegal.'}, {'ForeName': 'Souleymane', 'Initials': 'S', 'LastName': 'Mboup', 'Affiliation': 'Le Dantec Laboratory of Bacteriology and Virology, Dakar, Senegal; Institut de Recherche en Santé, de Surveillance Epidemiologique et de Formations, Dakar, Senegal.'}, {'ForeName': 'Babajide', 'Initials': 'B', 'LastName': 'Keshinro', 'Affiliation': 'Walter Reed Program, Abuja, Nigeria.'}, {'ForeName': 'Thompson N', 'Initials': 'TN', 'LastName': 'Kinge', 'Affiliation': 'Bamenda Regional Hospital, Bamenda, Cameroon.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Vernet', 'Affiliation': 'Centre Pasteur du Cameroun, Yaounde, Cameroon.'}, {'ForeName': 'Jean Joel', 'Initials': 'JJ', 'LastName': 'Bigna', 'Affiliation': 'Centre Pasteur du Cameroun, Yaounde, Cameroon.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Oguche', 'Affiliation': 'University of Jos and Jos University Teaching Hospital, Jos, Nigeria.'}, {'ForeName': 'Kwadwo A', 'Initials': 'KA', 'LastName': 'Koram', 'Affiliation': 'Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Accra, Ghana.'}, {'ForeName': 'Kwaku P', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Gobert', 'Affiliation': 'Quintiles, La Defense Cedex, France.'}, {'ForeName': 'Wayne R', 'Initials': 'WR', 'LastName': 'Hogrefe', 'Affiliation': 'Q(2) Solutions, San Juan Capistrano, CA, USA.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'De Ryck', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Debois', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bourguignon', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jongert', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Ballou', 'Affiliation': 'GSK, Rockville, MD, USA.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Koutsoukos', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Roman', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30019-0']
3167,32144316,Efficacy of local infiltration analgesia with ropivacaine for postoperative pain management in cervical laminoplasty: a retrospective study.,"Poor postoperative pain control impairs patient recovery and lengthens the duration of hospitalization after various surgeries. Local infiltration analgesia(LIA) has become an effective method for managing postoperative pain. This study aimed to investigate the efficacy of LIA with ropivacaine for postoperative pain control after cervical laminoplasty. In total, 68 patients undergoing cervical laminoplasty were included for retrospective review and divided into ropivacaine and control groups. The visual analogue scale (VAS) score, postoperative analgesic consumption, operative duration, intraoperative blood loss volume, incision length, hospitalization duration and incidence of complications were analyzed. In the ropivacaine group, the VAS score was 3.2 ± 1.4 at 4 hours postoperatively, which was lower than that of the control group(4.0 ± 1.4, P = 0.024). At 8, 12 and 24 hours after surgery, a significant difference was detected in the VAS score between the two groups(P ≤ 0.015). Sufentanil consumption was less in the ropivacaine group than in the control group in the first 4 hours postoperatively (25.6 ± 6.3 µg vs 32.2 ± 6.8 µg, P < 0.001), and similar results were observed in the first 8, 12, 24, 48 and 72 hours postoperatively(P < 0.001). Fewer patients required rescue analgesia in the ropivacaine group(8/33 vs 18/35 at 4-8 hours, P = 0.021; 9/33 vs 21/35 at 8-12 hours, P = 0.007). The hospitalization duration and time to ambulation were shorter in the ropivacaine group(8.5 ± 1.4 vs 9.6 ± 1.6 for postoperative duration, P = 0.002; 2.9 ± 0.7 vs 3.5 ± 0.8 for time to ambulation, P = 0.001). The incidence of nausea and vomiting was lower in the ropivacaine group than in the control group(30.3% vs 54.3%, P = 0.046). In conclusion, LIA with ropivacaine could effectively reduce postoperative pain, and postoperative analgesic consumption, and promote recovery after cervical laminoplasty.",2020,"At 8, 12 and 24 hours after surgery, a significant difference was detected in the VAS score between the two groups(P ≤ 0.015).","['cervical laminoplasty', 'postoperative pain control after cervical laminoplasty', '68 patients undergoing cervical laminoplasty']","['LIA with ropivacaine', 'ropivacaine']","['VAS score', 'postoperative pain, and postoperative analgesic consumption', 'visual analogue scale (VAS) score, postoperative analgesic consumption, operative duration, intraoperative blood loss volume, incision length, hospitalization duration and incidence of complications', 'Sufentanil consumption', 'duration of hospitalization', 'hospitalization duration and time to ambulation', 'nausea and vomiting', 'rescue analgesia']","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1535956', 'cui_str': 'Laminoplasty'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]",68.0,0.0511256,"At 8, 12 and 24 hours after surgery, a significant difference was detected in the VAS score between the two groups(P ≤ 0.015).","[{'ForeName': 'Kunpeng', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ""Department of Orthopaedics, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Orthopaedics, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Luo', 'Affiliation': ""Department of Orthopaedics, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Hongyong', 'Initials': 'H', 'LastName': 'Feng', 'Affiliation': ""Department of Orthopaedics, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Changbin', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': ""Department of Orthopaedics, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Keshi', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': ""Department of Orthopaedics, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Jinlong', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Orthopaedics, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Honglei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Orthopaedics, Liaocheng People's Hospital, Liaocheng, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopaedics, Liaocheng People's Hospital, Liaocheng, China. xuhspine@163.com.""}]",Scientific reports,['10.1038/s41598-020-61229-2']
3168,32152377,Implications of early diagnosis of autosomal dominant polycystic kidney disease: A post hoc analysis of the TEMPO 3:4 trial.,"It is unknown whether early diagnosis of autosomal dominant polycystic kidney disease (ADPKD) can enable earlier management and improve outcomes. We conducted a post hoc analysis of data from the TEMPO 3:4 trial. Subjects were stratified by ADPKD diagnosis at age ≤18 (childhood diagnosis [CD]) or>18 (adulthood diagnosis [AD]). Groups were compared for baseline characteristics and total kidney volume (TKV) growth and estimated glomerular filtration rate (eGFR) decline over 3 years. 294 CD and 1148 AD subjects were analyzed. At inclusion, CD subjects were younger (mean age 34.2 versus 39.8 years; p < 0.0001) and had better eGFR (mean ± SD 87.4 ± 23.9 versus 80.1 ± 20.7 mL/min/1.73 m 2 ; p < 0.0001), while CD had more severe Mayo risk classification (p < 0.0001) and more PKD1 mutations (p = 0.003). No statistical differences were found in TKV or eGFR change. At study end, placebo-treated CD subjects had better eGFR than projected by a prediction equation (mean difference ±SD for observed versus predicted eGFR: 2.18 ± 10.7 mL/min/1.73 m 2 ; p = 0.0475). However, these results are not confirmed when excluding stage 1 CKD. Whether CD subjects, despite their risk profile, have a slower disease course than predicted remains inconclusive. Future studies are needed to confirm that early diagnosis and management can alter the disease course of ADPKD.",2020,"At inclusion, CD subjects were younger (mean age 34.2 versus 39.8 years; p < 0.0001) and had better eGFR (mean ± SD 87.4 ± 23.9 versus 80.1 ± 20.7 mL/min/1.73 m 2 ; p < 0.0001), while CD had more severe Mayo risk classification (p < 0.0001) and more PKD1 mutations (p = 0.003).","['294 CD and 1148 AD subjects', 'Subjects were stratified by ADPKD diagnosis at age ≤18 (childhood diagnosis [CD]) or>18 (adulthood diagnosis [AD', 'autosomal dominant polycystic kidney disease']",['placebo-treated CD'],"['severe Mayo risk classification', 'TKV or eGFR change', 'total kidney volume (TKV) growth and estimated glomerular filtration rate (eGFR) decline', 'PKD1 mutations']","[{'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0085413', 'cui_str': 'ADPKD'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0700597', 'cui_str': 'Adulthood - period'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C3811844'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]",,0.0952539,"At inclusion, CD subjects were younger (mean age 34.2 versus 39.8 years; p < 0.0001) and had better eGFR (mean ± SD 87.4 ± 23.9 versus 80.1 ± 20.7 mL/min/1.73 m 2 ; p < 0.0001), while CD had more severe Mayo risk classification (p < 0.0001) and more PKD1 mutations (p = 0.003).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Janssens', 'Affiliation': 'PKD Research Group, Laboratory of Pediatrics, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Jouret', 'Affiliation': 'Division of Nephrology, University of Liège Hospital (ULiège CHU), Liège, Belgium.'}, {'ForeName': 'Bert', 'Initials': 'B', 'LastName': 'Bammens', 'Affiliation': 'Department of Microbiology & Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Max C', 'Initials': 'MC', 'LastName': 'Liebau', 'Affiliation': 'Department of Pediatrics and Center for Molecular Medicine, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Schaefer', 'Affiliation': ""Division of Pediatric Nephrology, University Children's Hospital Heidelberg, Heidelberg, Germany.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Dandurand', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, USA.'}, {'ForeName': 'Ronald D', 'Initials': 'RD', 'LastName': 'Perrone', 'Affiliation': 'Division of Nephrology, Tufts Medical Center and Tufts University School of Medicine, Boston, USA.'}, {'ForeName': 'Roman-Ulrich', 'Initials': 'RU', 'LastName': 'Müller', 'Affiliation': 'Department II of Internal Medicine and Center for Molecular Medicine Cologne, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany.'}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Pao', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, USA.'}, {'ForeName': 'Djalila', 'Initials': 'D', 'LastName': 'Mekahli', 'Affiliation': 'PKD Research Group, Laboratory of Pediatrics, University Hospitals Leuven, Leuven, Belgium. djalila.mekahli@uzleuven.be.'}]",Scientific reports,['10.1038/s41598-020-61303-9']
3169,30715779,Mechanisms linking height to early child development among infants and preschoolers in rural India.,"Stunting has been negatively associated with children's development. We examined the range of height by testing hypotheses: (a) height is positively associated with children's development, with associations moderated by inflammation and (b) home environments characterized by nurturance and early learning opportunities is positively associated with children's development over time and attenuate associations with height. Data included 513 infants (mean age 8.6 months) and 316 preschoolers (mean age 36.6 months) in rural India from a randomized controlled trial of multiple micronutrient powders (MNPs). Measures included height (height-for-age z-scores based on WHO standards), inflammation (C-reactive protein concentration >5 mg/L), nurturance (HOME Inventory), child development (Mullens Scales of Early Learning), and inhibitory control (preschoolers). Linear mixed effects models accounting for repeated measures, clustering, and confounders were used to assess associations between height and child development over time (infants: enrollment, 6 and 12 months; preschoolers: enrollment and 8 months). Moderating effects of inflammation and nurturance were tested with interaction terms. Among infants and preschoolers, height and nurturance were positively associated with all domains of child development over time, with the exception of inhibitory control. Among preschoolers, in the presence of inflammation, height was not associated with child development. Among infants, but not preschoolers, a nurturant home environment attenuated significant associations between height with fine motor and receptive language development. The mechanisms associated with children's development over time are multifactorial and include direct and indirect associations among nutrition, health, and the home environment, as supported by the Nurturing Care Framework.",2019,"Among infants and preschoolers, height and nurturance were positively associated with all domains of child development over time, with the exception of inhibitory control.","['513 infants (mean age 8.6\xa0months) and 316 preschoolers (mean age 36.6\xa0months) in rural India from a randomized controlled trial of multiple micronutrient powders (MNPs', 'infants and preschoolers in rural India']",[],"['nurturance (HOME Inventory), child development (Mullens Scales of Early Learning), and inhibitory control (preschoolers', 'height with fine motor and receptive language development', 'height (height-for-age z-scores based on WHO standards), inflammation']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}]",[],"[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0222045'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0023013', 'cui_str': 'Language Development'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",513.0,0.0189233,"Among infants and preschoolers, height and nurturance were positively associated with all domains of child development over time, with the exception of inhibitory control.","[{'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Black', 'Affiliation': 'Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Doris P', 'Initials': 'DP', 'LastName': 'Yimgang', 'Affiliation': 'Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, MD.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Hurley', 'Affiliation': 'Center for Human Nutrition, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Kimberly B', 'Initials': 'KB', 'LastName': 'Harding', 'Affiliation': 'Nutrition International, Ottawa, ON, Canada.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Fernandez-Rao', 'Affiliation': 'National Institute of Nutrition, Hyderabad, Telangana, India.'}, {'ForeName': 'Nagalla', 'Initials': 'N', 'LastName': 'Balakrishna', 'Affiliation': 'National Institute of Nutrition, Hyderabad, Telangana, India.'}, {'ForeName': 'Kankipati V', 'Initials': 'KV', 'LastName': 'Radhakrishna', 'Affiliation': 'National Institute of Nutrition, Hyderabad, Telangana, India.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Reinhart', 'Affiliation': 'Mathile Institute for the Advancement of Human Nutrition, Dayton, OH.'}, {'ForeName': 'Krishnapillai Madhavan', 'Initials': 'KM', 'LastName': 'Nair', 'Affiliation': 'National Institute of Nutrition, Hyderabad, Telangana, India.'}]",Developmental science,['10.1111/desc.12806']
3170,31882530,Prevalence and correlates of periodic limb movements in OSA and the effect of CPAP therapy.,"OBJECTIVE


We sought to assess the prevalence, correlates, and consequences of periodic limb movements of sleep (PLMS) in persons with obstructive sleep apnea (OSA) and the effect (worsening or improvement) of continuous positive airway pressure (CPAP) therapy on PLMS in a large prospective multicenter randomized controlled trial.
METHODS


We performed retrospective analyses of data from the Apnea Positive Pressure Long-term Efficacy Study, a prospective multicenter randomized controlled trial. A total of 1,105 persons with OSA enrolled in this study underwent a polysomnographic investigation at baseline, another one for CPAP titration, and another study 6 months after randomization to either active CPAP or sham CPAP.
RESULTS


Of all participants, 19.7% had PLM index (PLMI) ≥10/hour, 14.8% had PLMI ≥15/hour, 12.1% had PLMI ≥20/hour, 9.3% had PLMI ≥25/hour, and 7.5% had PLMI ≥30/hour. The odds of having a PLMI ≥10 were higher in older participants (odds ratio [OR] 1.03,  p  < 0.001), men (OR 1.63.  p  = 0.007), those using antidepressants (OR 1.48.  p  = 0.048), and those with higher caffeine use (OR 1.01,  p  = 0.04). After controlling for OSA and depression, PLMS were associated with increased sleep latency, reduced sleep efficiency, and reduced total sleep time. No significant relationships were noted between PLMS frequency and subjective sleepiness (Epworth Sleepiness Scale score) or objective sleepiness (Maintenance of Wakefulness Test). There was no differential effect of CPAP in comparison to sham CPAP on PLMS after 6 months of therapy.
CONCLUSIONS


PLMS are common in patients with OSA and are associated with a significant reduction in sleep quality over and above that conferred by OSA. Treatment with CPAP does not affect the severity of PLMS.",2020,No significant relationships were noted between PLMS frequency and subjective sleepiness (Epworth Sleepiness Scale score) or objective sleepiness (Maintenance of Wakefulness Test).,"['persons with obstructive sleep apnea (OSA', '1,105 persons with OSA enrolled', 'patients with OSA']","['continuous positive airway pressure (CPAP) therapy', 'active CPAP or sham CPAP', 'PLMI', 'CPAP therapy', 'periodic limb movements of sleep (PLMS', 'CPAP']","['PLMS frequency and subjective sleepiness (Epworth Sleepiness Scale score) or objective sleepiness (Maintenance of Wakefulness Test', 'sleep quality', 'PLM index', 'total sleep time', 'sleep latency, reduced sleep efficiency', 'severity of PLMS']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332182', 'cui_str': 'Periodic (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",1105.0,0.121071,No significant relationships were noted between PLMS frequency and subjective sleepiness (Epworth Sleepiness Scale score) or objective sleepiness (Maintenance of Wakefulness Test).,"[{'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Budhiraja', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson. rbudhiraja@bwh.harvard.edu.""}, {'ForeName': 'Sogol', 'Initials': 'S', 'LastName': 'Javaheri', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson.""}, {'ForeName': 'Milena K', 'Initials': 'MK', 'LastName': 'Pavlova', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson.""}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Epstein', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson.""}, {'ForeName': 'Olabimpe', 'Initials': 'O', 'LastName': 'Omobomi', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson.""}, {'ForeName': 'Stuart F', 'Initials': 'SF', 'LastName': 'Quan', 'Affiliation': ""From the Divisions of Sleep and Circadian Disorders (R.B., S.J., L.J.E., O.O., S.F.Q.) and Pulmonary and Critical Care Medicine (R.B.), Department of Medicine, and Division of Sleep and Circadian Disorders (M.K.P.), Department of Neurology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; and Arizona Respiratory Center (S.F.Q.), University of Arizona, Tucson.""}]",Neurology,['10.1212/WNL.0000000000008844']
3171,32152335,Melinjo seed extract increases adiponectin multimerization in physiological and pathological conditions.,"Melinjo seed extract (MSE) contains large amounts of polyphenols, including dimers of trans-resveratrol (e.g. gnetin C, L, gnemonoside A, B and D), and has been shown to potentially improve obesity. However, there is no clinical evidence regarding the anti-obesity effects of MSE, and its mechanisms are also unclear. We investigated the hypothesis that MSE supplementation increases the adiponectin (APN) multimerization via the up-regulation of disulfide bond A oxidoreductase-like protein (DsbA-L) under either or both physiological and obese conditions. To investigate the effect of MSE on the physiological condition, 42 healthy young volunteers were enrolled in a randomized, double-blind placebo-controlled clinical trial for 14 days. The participants were randomly assigned to the MSE 150 mg/day, MSE 300 mg/day or placebo groups. Furthermore, in order to investigate the effect of MSE on APN levels under obese conditions, we administered MSE powder (500 or 1000 mg/kg/day) to control-diet- or high-fat-diet (HFD)-fed C57BL/6 mice for 4 weeks. All participants completed the clinical trial. The administration of MSE 300 mg/day was associated with an increase in the ratio of HMW/total APN in relation to the genes regulating APN multimerization, including DsbA-L. Furthermore, this effect of MSE was more pronounced in carriers of the DsbA-L rs191776 G/T or T/T genotype than in others. In addition, the administration of MSE to HFD mice suppressed their metabolic abnormalities (i.e. weight gain, increased blood glucose level and fat mass accumulation) and increased the levels of total and HMW APN in serum and the mRNA levels of ADIPOQ and DsbA-L in adipose tissue. The present study suggests that MSE may exert beneficial effects via APN multimerization in relation to the induction of DsbA-L under both physiological and obese conditions.",2020,"The administration of MSE 300 mg/day was associated with an increase in the ratio of HMW/total APN in relation to the genes regulating APN multimerization, including DsbA-L.",['42 healthy young volunteers'],"['Melinjo seed extract', 'Melinjo seed extract (MSE', 'placebo', 'MSE', 'MSE supplementation', 'MSE 150\u2009mg/day, MSE 300\u2009mg/day or placebo', 'MSE powder']","['adiponectin (APN) multimerization', 'levels of total and HMW APN in serum and the mRNA levels of ADIPOQ and DsbA-L in adipose tissue', 'metabolic abnormalities (i.e. weight gain, increased blood glucose level and fat mass accumulation', 'ratio of HMW/total APN']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}]","[{'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",42.0,0.193401,"The administration of MSE 300 mg/day was associated with an increase in the ratio of HMW/total APN in relation to the genes regulating APN multimerization, including DsbA-L.","[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Oniki', 'Affiliation': 'Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan. oniken@kumamoto-u.ac.jp.'}, {'ForeName': 'Taisei', 'Initials': 'T', 'LastName': 'Kawakami', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Azusa', 'Initials': 'A', 'LastName': 'Nakashima', 'Affiliation': 'Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Keishi', 'Initials': 'K', 'LastName': 'Miyata', 'Affiliation': 'Department of Molecular Genetics, Graduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Takehisa', 'Initials': 'T', 'LastName': 'Watanabe', 'Affiliation': 'Departments of Gastroenterology and Hepatology, Faculty of Life Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Fujikawa', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Ryunosuke', 'Initials': 'R', 'LastName': 'Nakashima', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Aoi', 'Initials': 'A', 'LastName': 'Nasu', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Eto', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Noriki', 'Initials': 'N', 'LastName': 'Takahashi', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Nohara', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Suico', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Kotani', 'Affiliation': 'Department of Organic Chemistry, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Yui', 'Initials': 'Y', 'LastName': 'Obata', 'Affiliation': 'Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Sakamoto', 'Affiliation': 'Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Seguchi', 'Affiliation': 'Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Saruwatari', 'Affiliation': 'Division of Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Imafuku', 'Affiliation': 'Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Watanabe', 'Affiliation': 'Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Maruyama', 'Affiliation': 'Department of Biopharmaceutics, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Kai', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Shuto', 'Affiliation': 'Department of Molecular Medicine, Graduate School of Pharmaceutical Sciences, Kumamoto University, Kumamoto, Japan.'}]",Scientific reports,['10.1038/s41598-020-61148-2']
3172,31928920,Traditional Chinese medicine in the treatment of idiopathic pulmonary fibrosis based on syndrome differentiation: Study protocol of an exploratory trial.,"BACKGROUND


Idiopathic pulmonary fibrosis (IPF) has a poor prognosis and is often a kind of heavy financial burden to patients. Currently, few treatments are available for IPF. Clinical practice of traditional Chinese medicine (TCM), using a syndrome differentiation approach, offers some treatment success in IPF. However, there is no sufficient evidence-based study of the role of TCM in IPF management to make strong conclusions. This study evaluates the efficacy and safety of TCM in the treatment of IPF.
METHODS AND DESIGN


A multicenter, exploratory, randomized, double-blind and placebo-controlled trial is planned. A total of 80 patients will be enrolled in the study, which will include 26 weeks of treatment. Participants will be randomly assigned into TCM group or control group in a 1:1 ratio. The TCM group will be given TCM granules based on syndrome differentiation. Formulae include Bao-fei Hua-xian granule for lung qi deficiency, Jin-shui Huan-xian granule for lung-kidney qi deficiency and Yang-qing Kang-xian granule for yin deficiency and inner heat. The control group will be given a corresponding TCM granule placebo. The efficacy and safety of interventions will be evaluated by the outcome variables, including frequencies of acute exacerbations, pulmonary function, clinical symptoms, dyspnea, health-related quality of life (HRQoL), 6-minute walk distance and safety indicators.
DISCUSSION


It is hypothesized that TCM will decrease the frequency of adverse events, improve pulmonary function and HRQoL, based on our clinical experience. This trial is the first study of TCM treatment in IPF that is based on syndrome differentiation and will evaluate the efficacy and safety of TCM in IPF.
TRIAL REGISTRATION


This study was registered on www.Chictr.org.cn: ChiCTR-IIR-17013532. Register date: November 24, 2017.",2020,"Clinical practice of traditional Chinese medicine (TCM), using a syndrome differentiation approach, offers some treatment success in IPF.","['Chictr.org.cn', '80 patients will be enrolled in the study, which will include 26\xa0weeks of treatment', 'Idiopathic pulmonary fibrosis (IPF']","['traditional Chinese medicine (TCM', 'placebo', 'TCM granule placebo', 'TCM', 'Traditional Chinese medicine']","['frequencies of acute exacerbations, pulmonary function, clinical symptoms, dyspnea, health-related quality of life (HRQoL), 6-minute walk distance and safety indicators', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}]","[{'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3853573', 'cui_str': 'Granules'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}]",80.0,0.186944,"Clinical practice of traditional Chinese medicine (TCM), using a syndrome differentiation approach, offers some treatment success in IPF.","[{'ForeName': 'Xue-Qing', 'Initials': 'XQ', 'LastName': 'Yu', 'Affiliation': 'Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan Province 450000, China; Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou, Henan Province 450046, China; Henan Key Laboratory of Chinese Medicine for Respiratory Diseases, Henan University of Chinese Medicine, Zhengzhou, Henan Province 450046, China.'}, {'ForeName': 'Shu-Guang', 'Initials': 'SG', 'LastName': 'Yang', 'Affiliation': 'Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan Province 450000, China; Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou, Henan Province 450046, China; Henan Key Laboratory of Chinese Medicine for Respiratory Diseases, Henan University of Chinese Medicine, Zhengzhou, Henan Province 450046, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan Province 450000, China; Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou, Henan Province 450046, China; Henan Key Laboratory of Chinese Medicine for Respiratory Diseases, Henan University of Chinese Medicine, Zhengzhou, Henan Province 450046, China.'}, {'ForeName': 'Jian-Sheng', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan Province 450000, China; Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of P.R. China, Henan University of Chinese Medicine, Zhengzhou, Henan Province 450046, China; Henan Key Laboratory of Chinese Medicine for Respiratory Diseases, Henan University of Chinese Medicine, Zhengzhou, Henan Province 450046, China. Electronic address: li_js8@163.com.'}]",Journal of integrative medicine,['10.1016/j.joim.2019.12.005']
3173,31931977,Adjustable gastric band surgery or medical management in patients with type 2 diabetes and obesity: three-year results of a randomized trial.,"BACKGROUND


Few randomized trials have compared surgical versus lifestyle and pharmacologic approaches for type 2 diabetes (T2D) patients with mild to moderate obesity.
OBJECTIVES


This study examined resolution of hyperglycemia (A1C <6.5% and fasting glucose <126 mg/dL) 3 years after randomization to either a laparoscopic adjustable gastric band (LAGB) or 1-year diabetes and weight management (DWM) program.
SETTING


University medical center, United States.
METHODS


Forty T2D patients (mean ± SD: age, 51.3 ±10.0 yr; weight 109.5 ± 15.0 kg; body mass index [BMI] 36.5 ± 3.7 kg/m 2 ; HBA1C 8.2% ± 1.2%) were randomized to LAGB (n = 18) or DWM (n = 22).
RESULTS


At 3 years, 13% of 16 patients in LAGB and 5% of 17 patients in DWM achieved resolution of hyperglycemia (P = .601), with a modestly greater reduction in antidiabetic medications in the surgical group (P = .054). Reductions from baseline in A1C were sustained at 3 years in LAGB (-.82% [95% CI: -1.62 to -.01], P = .046) compared with DWM (+.23% [95% CI: -.57 to 1.03], P = .567). The surgical group had greater weight loss (-12.0 kg [95% CI: -15.9 to -8.1] versus -4.8 [95% CI: -8.6 to -.9], P = .010). HDL-cholesterol increased more after surgery (P = .003), but changes in triglycerides, LDL-cholesterol, and blood pressure did not differ between treatments. Diabetes- and obesity-specific quality of life improved comparably with both therapies.
CONCLUSIONS


Achievement of American Diabetes Association targets for glucose, lipids, and blood pressure was similar with both treatment strategies. LAGB leads to greater sustained weight loss and higher HDL cholesterol compared with a DWM program. These findings may help guide patients with T2D and obesity when exploring options for diabetes and weight management.",2019,"HDL-cholesterol increased more after surgery (P = .003), but changes in triglycerides, LDL-cholesterol, and blood pressure did not differ between treatments.","['patients\xa0with type 2 diabetes and obesity', 'Forty T2D patients (mean ± SD: age, 51.3 ±10.0 yr; weight 109.5 ± 15.0 kg; body mass index [BMI] 36.5 ± 3.7 kg/m 2 ; HBA1C 8.2% ± 1.2', 'University medical center, United States', 'type 2 diabetes (T2D) patients with mild to moderate obesity']","['DWM', 'laparoscopic adjustable gastric band (LAGB) or 1-year diabetes and weight management (DWM) program', 'Adjustable gastric band surgery or medical management', 'LAGB']","['weight loss', 'sustained weight loss and higher HDL cholesterol', 'glucose, lipids, and blood pressure', 'resolution of hyperglycemia', 'triglycerides, LDL-cholesterol, and blood pressure', 'Diabetes- and obesity-specific quality of life', 'HDL-cholesterol', 'antidiabetic medications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517696', 'cui_str': '3.7 (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C3854330', 'cui_str': 'Gastric band (physical object)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}]",,0.0611293,"HDL-cholesterol increased more after surgery (P = .003), but changes in triglycerides, LDL-cholesterol, and blood pressure did not differ between treatments.","[{'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Simonson', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: dsimonso@hsph.harvard.edu.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Vernon', 'Affiliation': ""Center for Metabolic and Bariatric Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Foster', 'Affiliation': 'Research Division, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Florencia', 'Initials': 'F', 'LastName': 'Halperin', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Mary Elizabeth', 'Initials': 'ME', 'LastName': 'Patti', 'Affiliation': 'Research Division, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Allison B', 'Initials': 'AB', 'LastName': 'Goldfine', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; Research Division, Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.""}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2019.03.038']
3174,31898874,"History of Cardiovascular Disease, Intensive Lifestyle Intervention, and Cardiovascular Outcomes in the Look AHEAD Trial.","OBJECTIVE


To examine the effects of an intensive lifestyle intervention (ILI) on cardiovascular disease (CVD), the Action for Health in Diabetes (Look AHEAD) trial randomized 5,145 participants with type 2 diabetes and overweight/obesity to a ILI or diabetes support and education. Although the primary outcome did not differ between the groups, there was suggestive evidence of heterogeneity for prespecified baseline CVD history subgroups (interaction P = 0.063). Event rates were higher in the ILI group among those with a CVD history (hazard ratio 1.13 [95% CI: 0.90-1.41]) and lower among those without CVD (hazard ratio 0.86 [95% CI: 0.72-1.02]).
METHODS


This study conducted post hoc analyses of the rates of the primary composite outcome and components, adjudicated cardiovascular death, nonfatal myocardial infarction (MI), stroke, and hospitalization for angina, as well as three secondary composite cardiovascular outcomes.
RESULTS


Interaction P values for the primary and two secondary composites were similar (0.060-0.064). Of components, the interaction was significant for nonfatal MI (P = 0.035). This interaction was not due to confounding by baseline variables, different intervention responses for weight loss and physical fitness, or hypoglycemic events. In those with a CVD history, statin use was high and similar by group. In those without a CVD history, low-density lipoprotein cholesterol levels were higher (P = 0.003) and statin use was lower (P ≤ 0.001) in the ILI group.
CONCLUSIONS


Intervention response heterogeneity was significant for nonfatal MI. Response heterogeneity may need consideration in a CVD-outcome trial design.",2020,"In those without a CVD history, low-density lipoprotein cholesterol levels were higher (P = 0.003) and statin use was lower (P ≤ 0.001) in the ILI group.
","['Diabetes', '5,145 participants with type 2 diabetes and overweight/obesity to a ILI or diabetes support and education']",['intensive lifestyle intervention (ILI'],"['adjudicated cardiovascular death, nonfatal myocardial infarction (MI), stroke, and hospitalization for angina, as well as three secondary composite cardiovascular outcomes', 'cardiovascular disease (CVD', 'weight loss and physical fitness, or hypoglycemic events', 'Event rates', 'nonfatal MI', 'low-density lipoprotein cholesterol levels']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]",5145.0,0.198386,"In those without a CVD history, low-density lipoprotein cholesterol levels were higher (P = 0.003) and statin use was lower (P ≤ 0.001) in the ILI group.
","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Cora E', 'Initials': 'CE', 'LastName': 'Lewis', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Bantle', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Alain G', 'Initials': 'AG', 'LastName': 'Bertoni', 'Affiliation': 'Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blackburn', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Brancati', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Bray', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Cheskin', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Curtis', 'Affiliation': ""Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases and St. Joseph's Hospital and Medical Center, Phoenix, Arizona, USA.""}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Egan', 'Affiliation': 'The Miriam Hospital, Brown Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Foreyt', 'Affiliation': 'Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Siran', 'Initials': 'S', 'LastName': 'Ghazarian', 'Affiliation': 'University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Barone Gibbs', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Glasser', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'W Gregg', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, Georgia, USA.'}, {'ForeName': 'Helen P', 'Initials': 'HP', 'LastName': 'Hazuda', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Hesson', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Horton', 'Affiliation': 'Joslin Diabetes Center, Boston, Massachusetts, USA.'}, {'ForeName': 'Van S', 'Initials': 'VS', 'LastName': 'Hubbard', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Jeffery', 'Affiliation': 'University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Johnson', 'Affiliation': 'The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Kahn', 'Affiliation': 'US Department of Veterans Affairs Puget Sound Health Care System, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Abbas E', 'Initials': 'AE', 'LastName': 'Kitabchi', 'Affiliation': 'The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Dalane', 'Initials': 'D', 'LastName': 'Kitzman', 'Affiliation': 'Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Knowler', 'Affiliation': 'Southwestern American Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Lipkin', 'Affiliation': 'US Department of Veterans Affairs Puget Sound Health Care System, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Michaels', 'Affiliation': 'Southwestern American Indian Center, Shiprock, New Mexico, USA.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Montez', 'Affiliation': 'University of Texas Health Science Center at San Antonio, San Antonio, Texas, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Nathan', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Ebenezer', 'Initials': 'E', 'LastName': 'Nyenwe', 'Affiliation': 'The University of Tennessee Health Science Center, Memphis, Tennessee, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Patricio', 'Affiliation': ""St. Luke's Roosevelt Hospital Center, Columbia University, New York, New York, USA.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': ""St. Luke's Roosevelt Hospital Center, Columbia University, New York, New York, USA.""}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Pownall', 'Affiliation': 'Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Reboussin', 'Affiliation': 'Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Donna H', 'Initials': 'DH', 'LastName': 'Ryan', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, Louisiana, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Lynne E', 'Initials': 'LE', 'LastName': 'Wagenknecht', 'Affiliation': 'Wake Forest University, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Wyatt', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'The Miriam Hospital, Brown Medical School, Providence, Rhode Island, USA.'}, {'ForeName': 'Susan Z', 'Initials': 'SZ', 'LastName': 'Yanovski', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22676']
3175,32199738,The oral health quality of life for seniors in residential facilities who have direct access to care as compared to those without access.,"INTRODUCTION


This pilot study tests whether there is a perceived difference in oral health when residents in long-term care facilities receive direct access to the scaling of teeth/debridement using dental hygiene instruments compared to facilities who provide only minimal oral hygiene care.
METHODS


The study was a quasi-experimental pretest/post-test control group design and took place at two long-term care senior residential facilities in Sheridan, Wyoming. Fifteen residents from each facility comprised the study sample (n = 30). The treatment group received a debridement and oral hygiene education and the control group received brushing, flossing, and oral hygiene education.
RESULTS


Results revealed a significant difference in pre/post OHIP-5 scores in the treatment group (p = 0.0222). The control group had improved scores, but it was not significant.
CONCLUSIONS


This study demonstrated a significant difference in the perception of oral health quality of life when seniors received a dental cleaning where they reside.",2020,"The control group had improved scores, but it was not significant.
","['Fifteen residents from each facility comprised the study sample (n\xa0=\xa030', 'seniors in residential facilities']","['debridement and oral hygiene education and the control group received brushing, flossing, and oral hygiene education']","['perception of oral health quality of life', 'pre/post OHIP-5 scores']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}]","[{'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0029162'}, {'cui': 'C0034380'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.029539,"The control group had improved scores, but it was not significant.
","[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Riggs', 'Affiliation': 'Department of Primary Dental Care, School of Dentistry, University of Minnesota, United States. Electronic address: sriggs@umn.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Blue', 'Affiliation': 'Division of Dental Hygiene, School of Dentistry, University of Minnesota, United States.'}, {'ForeName': 'Jennafer', 'Initials': 'J', 'LastName': 'Golden', 'Affiliation': 'Division of Dental Hygiene, School of Dentistry, University of Minnesota, United States.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2019.12.004']
3176,32179844,Use of mouse-tracking software to detect faking-good behavior on personality questionnaires: an explorative study.,"The aim of the present study was to explore whether kinematic indicators could improve the detection of subjects demonstrating faking-good behaviour when responding to personality questionnaires. One hundred and twenty volunteers were randomly assigned to one of four experimental groups (honest unspeeded, faking-good unspeeded, honest speeded, and faking-good speeded). Participants were asked to respond to the MMPI-2 underreporting scales (L, K, S) and the PPI-R Virtuous Responding (VR) scale using a computer mouse. The collected data included T-point scores on the L, K, S, and VR scales; response times on these scales; and several temporal and spatial mouse parameters. These data were used to investigate the presence of significant differences between the two manipulated variables (honest vs. faking-good; speeded vs. unspeeded). The results demonstrated that T-scores were significantly higher in the faking-good condition relative to the honest condition; however, faking-good and honest respondents showed no statistically significant differences between the speeded and unspeeded conditions. Concerning temporal and spatial kinematic parameters, we observed mixed results for different scales and further investigations are required. The most consistent finding, albeit with small observed effects, regards the L scale, in which faking-good respondents took longer to respond to stimuli and outlined wider mouse trajectories to arrive at the given response.",2020,"The results demonstrated that T-scores were significantly higher in the faking-good condition relative to the honest condition; however, faking-good and honest respondents showed no statistically significant differences between the speeded and unspeeded conditions.",['One hundred and twenty volunteers'],"['faking-good unspeeded, honest speeded, and faking-good speeded', 'mouse-tracking software']","['MMPI-2 underreporting scales (L, K, S) and the PPI-R Virtuous Responding (VR) scale', 'personality questionnaires', 'T-point scores on the L, K, S, and VR scales; response times on these scales; and several temporal and spatial mouse parameters', 'T-scores']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0037585', 'cui_str': 'Computer Programs'}]","[{'cui': 'C0026320', 'cui_str': 'Minnesota Multiphasic Personality Inventory'}, {'cui': 'C0222045'}, {'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3854607', 'cui_str': 'T score'}]",120.0,0.012704,"The results demonstrated that T-scores were significantly higher in the faking-good condition relative to the honest condition; however, faking-good and honest respondents showed no statistically significant differences between the speeded and unspeeded conditions.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Mazza', 'Affiliation': 'Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Merylin', 'Initials': 'M', 'LastName': 'Monaro', 'Affiliation': 'Department of General Psychology, University of Padova, Padova, Italy.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'Burla', 'Affiliation': 'Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colasanti', 'Affiliation': 'Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Graziella', 'Initials': 'G', 'LastName': 'Orrù', 'Affiliation': 'Department of Surgical, Medical, Molecular & Critical Area Pathology, University of Pisa, Pisa, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ferracuti', 'Affiliation': 'Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Roma', 'Affiliation': 'Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy. paolo.roma@uniroma1.it.'}]",Scientific reports,['10.1038/s41598-020-61636-5']
3177,32180862,Angiotensin receptor blockade with Losartan attenuates pressor response to handgrip contraction and enhances natriuresis in salt loaded hypertensive subjects: a quasi-experimental study among Nigerian adults.,"Introduction


Sympathetic and Renin-Angiotensin-Aldosterone systems play crucial roles in blood pressure response to increased salt intake. This study investigated the effects of angiotensin receptor blocker (ARB) and sympathetic excitation on the responses of blood pressure (BP) and peripheral vascular resistance (PVR) in salt loaded normotensive (NT) and hypertensive (HT) Nigerian subjects.
Methods


16 NT and 14 HT participants, that were age-matched [39.9 ± 1.3 vs 44.1±2.1yrs (P= 0.10)], underwent 5 days each of oral administration of 200mmol NaCl, and 200mmol NaCl + 50mg Losartan, preceded by a baseline control condition. BP and PVR responses to 30% Maximum Voluntary Contraction (MVC) of handgrip (HG) for one minute were determined at baseline, after salt load and after salt + Losartan. Data were presented as Mean ± SEM, and analyzed with two-way ANOVA and paired t-test, with P<0.05 accepted as significant.
Results


BP and PVR were significantly increased by HG at baseline, after salt load and after salt + Losartan in NT and HT. Salt load augmented the HG-induced SBP (P=0.04) and MABP responses (P=0.02) in HT. While Losartan attenuated the HG- induced Systolic Blood Pressure (SBP) SBP response (P=0.007) and DBP response (P=0.003) in HT and NT respectively after salt + Losartan. HG-induced PVR response was significantly accentuated after salt load in HT (P=0.005), but it was not significant in NT (P=0.38).
Conclusion


The implication of our finding is that angiotensin II receptor blockade possibly attenuates salt-induced sympathetic nerve excitation in black hypertensive patients.",2019,Salt load augmented the HG-induced SBP (P=0.04) and MABP responses (P=0.02) in HT.,"['Nigerian adults', 'Methods\n\n\n16 NT and 14 HT participants, that were age-matched [39.9 ± 1.3 vs 44.1±2.1yrs (P= 0.10', 'black hypertensive patients', 'salt loaded normotensive (NT) and hypertensive (HT) Nigerian subjects', 'salt loaded hypertensive subjects']","['angiotensin receptor blocker (ARB) and sympathetic excitation', '200mmol NaCl, and 200mmol NaCl + 50mg Losartan', 'Losartan', 'salt + Losartan']","['HG-induced PVR response', 'MABP responses', 'HG-induced SBP', 'BP and PVR responses', 'HG- induced Systolic Blood Pressure (SBP) SBP response', 'blood pressure response', 'DBP response', 'BP and PVR', 'blood pressure (BP) and peripheral vascular resistance (PVR']","[{'cui': 'C1556089', 'cui_str': 'Nigerians (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4517499', 'cui_str': '1.3 (qualifier value)'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure (finding)'}]","[{'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0036140', 'cui_str': 'Salts'}]","[{'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1997183', 'cui_str': 'Speed of blood pressure response (observable entity)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1258192', 'cui_str': 'Total Peripheral Resistance'}]",,0.0353844,Salt load augmented the HG-induced SBP (P=0.04) and MABP responses (P=0.02) in HT.,"[{'ForeName': 'Francis Muyiwa', 'Initials': 'FM', 'LastName': 'Agbaraolorunpo', 'Affiliation': 'Department of Physiology, College of Medicine, University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Olusoga Adekunle', 'Initials': 'OA', 'LastName': 'Sofola', 'Affiliation': 'Department of Physiology, College of Medicine, University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Chikodi Nnanyelu', 'Initials': 'CN', 'LastName': 'Anigbogu', 'Affiliation': 'Department of Physiology, College of Medicine, University of Lagos, Lagos, Nigeria.'}, {'ForeName': 'Elaine Chinyelu', 'Initials': 'EC', 'LastName': 'Azinge', 'Affiliation': 'Department of Clinical Pathology, College of Medicine, University of Lagos, Lagos, Nigeria.'}]",The Pan African medical journal,['10.11604/pamj.2019.34.188.18317']
3178,31907186,Pharmacokinetics and  Ex Vivo  Antimalarial Activity of Artesunate-Amodiaquine plus Methylene Blue in Healthy Volunteers.,"High rates of artemisinin-based combination therapy (ACT) failures in the treatment of  Plasmodium falciparum  malaria in Southeast Asia have led to triple-drug strategies to extend the useful life of ACTs. In this study, we determined whether methylene blue [MB; 3,7-bis(dimethylamino)phenothiazin-5-ium chloride hydrate] alters the pharmacokinetics of artesunate-amodiaquine (ASAQ) and enhances the  ex vivo  antimalarial activity of ASAQ. In an open-label, randomized crossover design, a single oral dose of ASAQ (200 mg AS/540 mg AQ) alone or with MB (325 mg) was administered to 15 healthy Vietnamese volunteers. Serial blood samples were collected up to 28 days after dosing. Pharmacokinetic properties of the drugs were determined by noncompartmental analysis. After drug administration, plasma samples from seven participants were assessed for  ex vivo  antimalarial activity against the artemisinin-sensitive MRA1239 and the artemisinin-resistant MRA1240  P. falciparum  lines,  in vitro  MB significantly increased the mean area under the curve of the active metabolite of AS, dihydroartemisinin (1,246 ± 473 versus 917 ± 405 ng·h/ml,  P  = 0.009) but did not alter the pharmacokinetics of AQ, AS, or desethylamodiaquine. Comparing the antimalarial activities of the plasma samples from the participants collected up to 48 h after ASAQ plus MB (ASAQ+MB) and ASAQ dosing against the MRA1239 and MRA1240 lines, MB significantly enhanced the blood schizontocidal activity of ASAQ by 2.0-fold and 1.9-fold, respectively. The ring-stage survival assay also confirmed that MB enhanced the  ex vivo  antimalarial activity of ASAQ against MRA1240 by 2.9-fold to 3.8-fold, suggesting that the triple-drug combination has the potential to treat artemisinin-resistant malaria and for malaria elimination. (This study has been registered in the Australian New Zealand Clinical Trials Registry [https://anzctr.org.au/] under registration number ACTRN12612001298808.).",2020,"The ring-stage survival assay also confirmed that MB enhances the  ex vivo  antimalarial activity of ASAQ against MRA1240 by 2.9 to 3.8-fold, suggesting that the triple drug combination has the potential to treat artemisinin-resistant malaria and for malaria elimination.","['Healthy Volunteers', 'Plasmodium falciparum  malaria in Southeast Asia', '15 healthy Vietnamese volunteers']","['Artesunate-Amodiaquine plus Methylene Blue', 'artesunate-amodiaquine (ASAQ', 'mg AQ) alone or with MB (325 mg MB', 'methylene blue (MB', 'ASAQ', 'High artesunate combination therapy (ACT']","['ex vivo  antimalarial activity against an artemisinin-sensitive (MRA1239', 'pharmacokinetics of AQ, AS or desethylamodiaquine', 'blood schizontocidal activity of ASAQ']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0024535', 'cui_str': 'Plasmodium falciparum Malaria'}, {'cui': 'C0003983', 'cui_str': 'Southeast Asia'}, {'cui': 'C1561452', 'cui_str': 'Vietnamese'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0052432', 'cui_str': 'artesunate'}, {'cui': 'C0002641', 'cui_str': 'Amodiaquine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0025746', 'cui_str': 'methylthioninium chloride'}, {'cui': 'C4517714', 'cui_str': 'Three hundred and twenty-five'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0003374', 'cui_str': 'Antimalarial Agents'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1136174', 'cui_str': 'Artemisinins'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0057523', 'cui_str': 'monodesethylamodiaquine'}, {'cui': 'C0005768'}]",917.0,0.0496453,"The ring-stage survival assay also confirmed that MB enhances the  ex vivo  antimalarial activity of ASAQ against MRA1240 by 2.9 to 3.8-fold, suggesting that the triple drug combination has the potential to treat artemisinin-resistant malaria and for malaria elimination.","[{'ForeName': 'Chu Xuan', 'Initials': 'CX', 'LastName': 'Anh', 'Affiliation': 'Institute for Clinical Infectious Diseases, Central Military Hospital 108, Hanoi, Vietnam.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Chavchich', 'Affiliation': 'Australian Defence Force Malaria and Infectious Disease Institute, Brisbane, Australia.'}, {'ForeName': 'Geoffrey W', 'Initials': 'GW', 'LastName': 'Birrell', 'Affiliation': 'Australian Defence Force Malaria and Infectious Disease Institute, Brisbane, Australia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Van Breda', 'Affiliation': 'Australian Defence Force Malaria and Infectious Disease Institute, Brisbane, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Travers', 'Affiliation': 'Australian Defence Force Malaria and Infectious Disease Institute, Brisbane, Australia.'}, {'ForeName': 'Kerryn', 'Initials': 'K', 'LastName': 'Rowcliffe', 'Affiliation': 'Australian Defence Force Malaria and Infectious Disease Institute, Brisbane, Australia.'}, {'ForeName': 'Anton R', 'Initials': 'AR', 'LastName': 'Lord', 'Affiliation': 'Queensland Institute of Medical Research Berghofer, Brisbane, Australia.'}, {'ForeName': 'G Dennis', 'Initials': 'GD', 'LastName': 'Shanks', 'Affiliation': 'Australian Defence Force Malaria and Infectious Disease Institute, Brisbane, Australia.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Edstein', 'Affiliation': 'Australian Defence Force Malaria and Infectious Disease Institute, Brisbane, Australia Mike.Edstein@defence.gov.au.'}]",Antimicrobial agents and chemotherapy,['10.1128/AAC.01441-19']
3179,31439831,Cannabidiol attenuates insular dysfunction during motivational salience processing in subjects at clinical high risk for psychosis.,"Accumulating evidence points towards the antipsychotic potential of cannabidiol. However, the neurocognitive mechanisms underlying the antipsychotic effect of cannabidiol remain unclear. We investigated this in a double-blind, placebo-controlled, parallel-arm study. We investigated 33 antipsychotic-naïve subjects at clinical high risk for psychosis (CHR) randomised to 600 mg oral cannabidiol or placebo and compared them with 19 healthy controls. We used the monetary incentive delay task while participants underwent fMRI to study reward processing, known to be abnormal in psychosis. Reward and loss anticipation phases were combined to examine a motivational salience condition and compared with neutral condition. We observed abnormal activation in the left insula/parietal operculum in CHR participants given placebo compared to healthy controls associated with premature action initiation. Insular activation correlated with both positive psychotic symptoms and salience perception, as indexed by difference in reaction time between salient and neutral stimuli conditions. CBD attenuated the increased activation in the left insula/parietal operculum and was associated with overall slowing of reaction time, suggesting a possible mechanism for its putative antipsychotic effect by normalising motivational salience and moderating motor response.",2019,"CBD attenuated the increased activation in the left insula/parietal operculum and was associated with overall slowing of reaction time, suggesting a possible mechanism for its putative antipsychotic effect by normalising motivational salience and moderating motor response.","['subjects at clinical high risk for psychosis', '19 healthy controls', '33 antipsychotic-naïve subjects at clinical high risk for psychosis (CHR) randomised to 600\u2009mg', 'CHR participants given']","['oral cannabidiol or placebo', 'placebo', 'CBD']","['reaction time', 'abnormal activation', 'positive psychotic symptoms and salience perception']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic Drugs'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C1947971', 'cui_str': 'Give'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",,0.165323,"CBD attenuated the increased activation in the left insula/parietal operculum and was associated with overall slowing of reaction time, suggesting a possible mechanism for its putative antipsychotic effect by normalising motivational salience and moderating motor response.","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Wilson', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Matthijs G', 'Initials': 'MG', 'LastName': 'Bossong', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Appiah-Kusi', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Petros', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brammer', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'Perez', 'Affiliation': 'CAMEO Early Intervention Service, Cambridgeshire and Peterborough NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Allen', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'McGuire', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sagnik', 'Initials': 'S', 'LastName': 'Bhattacharyya', 'Affiliation': ""Department of Psychosis Studies, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. sagnik.2.bhattacharyya@kcl.ac.uk.""}]",Translational psychiatry,['10.1038/s41398-019-0534-2']
3180,32155323,Changes in muscle power after usual care or early structured exercise intervention in acutely hospitalized older adults.,"BACKGROUND


A classic consequence of short-term bed rest in older adults is the significant loss in skeletal muscle mass and muscle strength that underlies the accelerated physical performance deficits. Structured exercise programmes applied during acute hospitalization can prevent muscle function deterioration.
METHODS


A single-blind randomized clinical trial conducted in an acute care for elders unit in a tertiary public hospital in Navarre (Spain). Three hundred seventy hospitalized patients [56.5% female patients; mean age (standard deviation) 87.3 (4.9) years] were randomly allocated to an exercise intervention (n = 185) or a control (n = 185) group (usual care). The intervention consisted of a multicomponent exercise training programme performed during 5-7 consecutive days (2 sessions/day). The usual-care group received habitual hospital care, which included physical rehabilitation when needed. The main endpoints were change in maximal dynamic strength (i.e. leg-press, chest-press, and knee extension exercises) and maximal isometric knee extensors and hip flexors strength from baseline to discharge. Changes in muscle power output at submaximal and maximal loads were also measured after the intervention.
RESULTS


The physical exercise programme provided significant benefits over usual care. At discharge, the exercise group showed a mean increase of 19.6 kg [95% confidence interval (CI), 16.0, 23.2; P < 0.001] on the one-repetition maximum (1RM) in the leg-press exercise, 5.7 kg (95% CI, 4.7, 6.8; P < 0.001) on the 1RM in the chest-press exercise, and 9.4 kg (95% CI, 7.3, 11.5; P < 0.001) on the 1RM in the knee extension exercise over usual-care group. There were improvements in the intervention group also in the isometric maximal knee extension strength [14.8 Newtons (N); 95% CI, 11.2, 18.5 vs. -7.8 N; 95% CI, -11.0, -3.5 in the control group; P < 0.001] and the hip flexion strength (13.6 N; 95% CI, 10.7, 16.5 vs. -7.2 N; 95% CI, -10.1, -4.3; P < 0.001). Significant benefits were also observed in the exercise group for the muscle power output at submaximal loads (i.e. 30% 1RM, 45% 1RM, 60% 1RM, and 75% 1RM; all P < 0.001) over usual-care group.
CONCLUSIONS


An individualized, multicomponent exercise training programme, with special emphasis on muscle power training, proved to be an effective therapy for improving muscle power output of lower limbs at submaximal loads and maximal muscle strength in older patients during acute hospitalization.",2020,"There were improvements in the intervention group also in the isometric maximal knee extension strength [14.8 Newtons (N); 95% CI, 11.2, 18.5 vs. -7.8 N; 95% CI, -11.0, -3.5 in the control group; P < 0.001] and the hip flexion strength (13.6 N; 95% CI, 10.7, 16.5 vs. -7.2 N; 95% CI, -10.1, -4.3; P < 0.001).","['elders unit in a tertiary public hospital in Navarre (Spain', 'acutely hospitalized older adults', 'older adults', 'older patients during acute hospitalization', 'Three hundred seventy hospitalized patients [56.5% female patients; mean age (standard deviation) 87.3 (4.9) years']","['Structured exercise programmes', 'habitual hospital care, which included physical rehabilitation', 'physical exercise programme', 'multicomponent exercise training programme', 'control (n\xa0=\xa0185) group (usual care', 'exercise intervention', 'usual care or early structured exercise intervention']","['one-repetition maximum (1RM', 'hip flexion strength', 'isometric maximal knee extension strength', 'maximal dynamic strength (i.e. leg-press, chest-press, and knee extension exercises) and maximal isometric knee extensors and hip flexors strength', 'muscle power output at submaximal loads', 'muscle power output at submaximal and maximal loads']","[{'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}]",370.0,0.075368,"There were improvements in the intervention group also in the isometric maximal knee extension strength [14.8 Newtons (N); 95% CI, 11.2, 18.5 vs. -7.8 N; 95% CI, -11.0, -3.5 in the control group; P < 0.001] and the hip flexion strength (13.6 N; 95% CI, 10.7, 16.5 vs. -7.2 N; 95% CI, -10.1, -4.3; P < 0.001).","[{'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Sáez de Asteasu', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Martínez-Velilla', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Fabricio', 'Initials': 'F', 'LastName': 'Zambom-Ferraresi', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Ramírez-Vélez', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'García-Hermoso', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Cadore', 'Affiliation': 'Laboratory of Exercise Research, School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Casas-Herrero', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Arkaitz', 'Initials': 'A', 'LastName': 'Galbete', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Navarrabiomed, Complejo Hospitalario de Navarra (CHN), Universidad Pública de Navarra (UPNA), IdiSNA, Pamplona, Spain.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12564']
3181,31761744,[Informed consent for anaesthesia: Presential or non-presential information?],"INTRODUCTION


The anaesthesia informed consent (AIC) is a process of communication between a clinician and a patient that results in the patient agreeing to undergo a specific anaesthetic procedure after understanding all the information needed to make a free, voluntary and conscious decision. This information is traditionally given during a face-to-face pre-operative visit.
OBJECTIVE


To evaluate patient perceptions when they receive the information about AIC, face-to-face or by phone.
PATIENTS AND METHODS


A single centre, randomised, double-blind, parallel-group pilot clinical trial was conducted on patients > 18 years of age undergoing major ambulatory surgery procedures with a surgical complexity that did not require a face-to-face pre-operative visit. Patients were randomly assigned to be informed by telephone (experimental group) or in a face- to-face visit (control group). Fifteen days after the surgery a questionnaire was used to gather patient perceptions in understanding the anaesthetic procedure and risks, autonomy (to ask for explanations), as well as and satisfaction.
RESULTS


Of the 160 patients that gave their consent, 142 were interviewed: 70 from the experimental group and 72 from the control group. Both groups were comparable in age, gender, anaesthetic risk, and surgical complexity. The percentage of patients that understood the information provided on the anaesthetic technique was 71% and 81%, respectively (P=.429); on its risks: 67% and 69% (P=.951); autonomy: 56% and 74% (P=.036) and satisfaction rate: 46% and 46% (P=.835).
CONCLUSION


There is no difference between the groups in the level of understanding of the information that the patient perceives and the level of satisfaction. Nevertheless, almost half of them did not remember to have been given the possibility to clear-up doubts.",2019,There is no difference between the groups in the level of understanding of the information that the patient perceives and the level of satisfaction.,"[' 142 were interviewed: 70 from the experimental group and 72 from the control group', '160 patients that gave their consent', 'patients > 18 years of age undergoing major ambulatory surgery procedures with a surgical complexity that did not require a face-to-face pre-operative visit']",['telephone (experimental group) or in a face- to-face visit (control group'],['satisfaction rate'],"[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory Surgery'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",142.0,0.0382257,There is no difference between the groups in the level of understanding of the information that the patient perceives and the level of satisfaction.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Faura', 'Affiliation': 'Servicio de Anestesiología y Reanimación, Hospital de Viladecans, Viladecans, Barcelona, España. Electronic address: anafauramessa@gmail.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Izquierdo', 'Affiliation': 'Servicio de Anestesiología y Reanimación, Hospital de Viladecans, Viladecans, Barcelona, España.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Escriche', 'Affiliation': 'Departamento de Admisiones y Documentación Clínica. Hospital de Viladecans, Viladecans, Barcelona, España.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Nogué', 'Affiliation': 'Unidad de Gestión de Pacientes, Hospital de Viladecans, Universidad de Barcelona, Barcelona, España.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Videla', 'Affiliation': ""Unidad de Soporte a la Investigación Clínica, Hospital Universitario de Bellvitge, Instituto de Investigación Biomédica de Bellvitge (IDIBELL)/Universidad de Barcelona, L'Hospitalet del Llobregat, Barcelona, España.""}]",Journal of healthcare quality research,['10.1016/j.jhqr.2019.07.004']
3182,32128938,"Illness uncertainty, coping, and quality of life among patients with prostate cancer.","OBJECTIVE


Illness uncertainty is a significant source of psychological distress that affects cancer patients' quality of life (QOL). Mishel's uncertainty in illness theory (UIT) proposes that illness uncertainty influences an individual's use of coping strategies, and directly and indirectly influences their QOL. This study tested the relationships depicted in the adapted UIT in cancer patients.
METHODS


This cross-sectional study is a secondary analysis of the baseline data from a randomized clinical trial (N = 263 prostate cancer patients). Patients were diagnosed with localized (64.6%), biochemical recurrent (12.6%), or advanced (22.8%) prostate cancer. Uncertainty, coping (avoidant and active coping strategies), and QOL (physical and mental well-being) were measured using the Mishel's uncertainty of illness scale, Brief COPE, and the Medical Outcomes Study 12-item short form (SF-12), respectively. We used path analysis to achieve the research aim.
RESULTS


Patients' illness uncertainty directly, negatively influenced their physical well-being (P < .001) and mental well-being (P < .05). Patients' illness uncertainty was positively related to their avoidant coping strategies (P < .001). Patients' active and avoidant coping strategies influenced their mental well-being (P < .001). Uncertainty also negatively influenced mental well-being through avoidant coping strategies. The model had excellent fit to the data.
CONCLUSIONS


Our findings have indicated the potential of improving QOL by decreasing illness uncertainty and reducing avoidant coping strategies. Future research is needed to better understand the complex relationships between illness uncertainty, coping strategies, and domains of QOL among patients with different types of cancer using longitudinal research.",2020,"RESULTS


Patients' illness uncertainty directly, negatively influenced their physical well-being (P < .001) and mental well-being (P < .05).","['patients with prostate cancer', 'Patients were diagnosed with localized (64.6%), biochemical recurrent (12.6%), or advanced (22.8%) prostate cancer', 'cancer patients', '263 prostate cancer patients']",[],"['Uncertainty, coping (avoidant and active coping strategies), and QOL (physical and mental well-being', 'Illness uncertainty, coping, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C4517545', 'cui_str': 'Twelve point six'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C4517671', 'cui_str': '263'}]",[],"[{'cui': 'C0087130', 'cui_str': 'Uncertainty'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0424578', 'cui_str': 'Sense of well-being'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0034380'}]",263.0,0.0364443,"RESULTS


Patients' illness uncertainty directly, negatively influenced their physical well-being (P < .001) and mental well-being (P < .05).","[{'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Guan', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Sheila Judge', 'Initials': 'SJ', 'LastName': 'Santacroce', 'Affiliation': 'School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Ding-Geng', 'Initials': 'DG', 'LastName': 'Chen', 'Affiliation': 'School of Social Work, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'School of Nursing, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Psycho-oncology,['10.1002/pon.5372']
3183,30718577,Self-assembly of dental surface nanofilaments and remineralisation by SnF 2  and CPP-ACP nanocomplexes.,"Dental caries, erosion and hypersensitivity are major public health problems. SnF 2  is used widely in oral care products to help prevent/treat these conditions. Casein phosphopeptide-stabilised amorphous calcium phosphate nanocomplexes (CPP-ACP) are a biomimetic nanotechnology of salivary phosphopeptide-ACP complexes that deliver bioavailable calcium and phosphate ions to promote dental remineralisation (repair). We show here using in vitro studies and a double-blind, randomised controlled, cross-over design in situ clinical trial that SnF 2  and CPP-ACP interact to form a nanofilament coating on the tooth surface and that together they are superior in their ability to promote dental remineralisation. Sn(II) by cross-linking the CPP-ACP helps to stabilise the complexes which improves delivery to the tooth surface and enhances binding and ion incorporation into tooth mineral. The combination of SnF 2  and CPP-ACP in oral care products may significantly improve their efficacy in prevention/treatment of dental caries/erosion and hypersensitivity.",2019,Sn(II) by cross-linking the CPP-ACP helps to stabilise the complexes which improves delivery to the tooth surface and enhances binding and ion incorporation into tooth mineral.,[],['Casein phosphopeptide-stabilised amorphous calcium phosphate nanocomplexes (CPP-ACP'],[],[],"[{'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C1956739', 'cui_str': 'Ca9(PO4)6'}, {'cui': 'C1120338', 'cui_str': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}]",[],,0.0514269,Sn(II) by cross-linking the CPP-ACP helps to stabilise the complexes which improves delivery to the tooth surface and enhances binding and ion incorporation into tooth mineral.,"[{'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Fernando', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peiyan', 'Initials': 'P', 'LastName': 'Shen', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christina P C', 'Initials': 'CPC', 'LastName': 'Sim', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Yu-Yen', 'Initials': 'YY', 'LastName': 'Chen', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Glenn D', 'Initials': 'GD', 'LastName': 'Walker', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'Reynolds', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Stanton', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Colin M', 'Initials': 'CM', 'LastName': 'MacRae', 'Affiliation': 'Microbeam Laboratory, CSIRO Mineral Resources, Clayton, Victoria, Australia.'}, {'ForeName': 'Eric C', 'Initials': 'EC', 'LastName': 'Reynolds', 'Affiliation': 'Oral Health Cooperative Research Centre, Melbourne Dental School, Bio21 Institute, The University of Melbourne, Melbourne, Victoria, Australia. e.reynolds@unimelb.edu.au.'}]",Scientific reports,['10.1038/s41598-018-37580-w']
3184,31963598,"Promoting Social and Emotional Learning and Subjective Well-Being: Impact of the ""Aislados"" Intervention Program in Adolescents.","The aim of this study is to experimentally assess the effects of an intervention program through a video game called ""Aislados"" for the improvement of subjective well-being, mental health and trait emotional intelligence of a sample of adolescents ( n  = 187). We used well-established measures with appropriate psychometric properties. The study used a quasi-experimental design of pre-test/post-test repeated measurements with a control group. First, a multivariate analysis of variance (MANOVA) and then descriptive analyses and variance analyses (ANOVAs) were carried out by the adolescents randomly assigned to the experimental and control conditions. Then, a multivariate analysis of covariance (MANCOVA) was performed on the study's variables as a whole. Descriptive and covariance analyses of the post-test scores were carried out (ANCOVAs post-test, co-varying pre-test scores), in order to demonstrate the impact of the program. The effect size was reckoned (Cohen's  d ). The results confirm statistically-significant differences in: Health-Related Quality of life, positive affect and mental health. The study provides an effective intervention tool which has been experimentally validated. The overall results allow for emphasizing the importance of the implementation of programs aimed at encouraging social and emotional learning throughout adolescence as protective resources in fostering emotional and behavioral adjustment in adolescents.",2020,"The results confirm statistically-significant differences in: Health-Related Quality of life, positive affect and mental health.","['Adolescents', 'sample of adolescents ( n  = 187']","['video game called ""Aislados', 'Aislados"" Intervention Program']","['Promoting Social and Emotional Learning and Subjective Well-Being', 'subjective well-being, mental health and trait emotional intelligence', ' Health-Related Quality of life, positive affect and mental health']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}]","[{'cui': 'C0042649', 'cui_str': 'Video Games'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0582589', 'cui_str': 'Emotional learning (observable entity)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1510539', 'cui_str': 'Emotional Intelligences'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}]",,0.0291618,"The results confirm statistically-significant differences in: Health-Related Quality of life, positive affect and mental health.","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cejudo', 'Affiliation': 'Faculty of Education of Ciudad Real, University of Castilla-La Mancha, 13071 Ciudad Real, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Losada', 'Affiliation': 'Department of Research Methods and Assessment in Education II, Faculty of Education, UNED, Juan del Rosal, 14, 28040 Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Feltrero', 'Affiliation': 'Higher Teacher Training Institute ""Salomé Ureña"", Calle Caonabo, Esquina Leonardo D\'Vinci, Santo Domingo 10114, Dominican Republic.'}]",International journal of environmental research and public health,['10.3390/ijerph17020609']
3185,32109425,"Gefapixant, a P2X3 receptor antagonist, for the treatment of refractory or unexplained chronic cough: a randomised, double-blind, controlled, parallel-group, phase 2b trial.","BACKGROUND


Gefapixant is a P2X3 receptor antagonist that has shown promise for the treatment of refractory and unexplained chronic cough. The aim of this study was to evaluate the efficacy of gefapixant compared with placebo after 12 weeks of treatment for refractory chronic cough or unexplained chronic cough.
METHODS


We did a 12-week, phase 2b, randomised, double-blind, placebo-controlled study in patients with refractory chronic cough or unexplained chronic cough aged 18-80 years who were recruited from 44 primarily outpatient pulmonologist or allergist sites in the UK and the USA. Eligible patients had refractory or unexplained chronic cough lasting 1 year or longer, no radiographic chest abnormality, and 40 mm or more on a 100-mm cough severity visual analogue scale at enrolment. Patients were randomly assigned to receive placebo or one of three doses (7·5 mg, 20 mg, or 50 mg) of oral gefapixant twice daily, every day, for 84 days; visits to investigative sites were on days 1, 28, 42, 56, 70, 84, and 85. The randomisation schedule was computer generated using a permuted block algorithm by Advance Research Associates (Santa Clara, CA, USA). Patients and all personnel involved in the conduct and interpretation of the study were masked to treatment assignment. The primary endpoint was placebo-adjusted change from baseline in awake cough frequency after 12 weeks, assessed in the full analysis set, which is a subset of the intention-to-treat population. Adverse events were monitored and safety was evaluated in all patients receiving one or more doses of study drug. This trial is registered with ClinicalTrials.gov, NCT02612610.
FINDINGS


Between Dec 21, 2015, and July 26, 2016, 253 patients were randomly assigned to placebo (n=63), gefapixant 7·5 mg (n=64), gefapixant 20 mg (n=63), or gefapixant 50 mg (n=63) twice daily. The mean age of patients was 60·2 (SD 9·9) years and 193 (76%) were women. At 12 weeks, patients' geometric mean awake cough frequency was 18·2 coughs per h (geometric SD 3·1) with placebo, and 14·5 coughs per h (3·7) with 7·5 mg, 12·0 coughs per h (4·2) with 20 mg, and 11·3 coughs per h (2·8) with 50 mg gefapixant. Estimated percentage change relative to placebo was -22·0% (-41·8 to 4·6; p=0·097) with 7·5 mg, -22·2% (-42·0 to 4·3; p=0·093) with 20 mg, and -37·0% (95% CI -53·3 to -14·9; p=0·0027) with 50 mg gefapixant. Dysgeusia was the most common adverse event, occurring in three (5%) patients given placebo, six (10%) given 7·5 mg gefapixant, 21 (33%) given 20 mg gefapixant, and 30 (48%) given 50 mg gefapixant.
INTERPRETATION


Targeting purinergic receptor P2X3 with gefapixant at a dose of 50 mg twice daily significantly reduced cough frequency in patients with refractory chronic cough or unexplained chronic cough after 12 weeks of treatment compared with placebo. Further development of gefapixant is warranted for the treatment of chronic cough.
FUNDING


Afferent Pharmaceuticals (acquired by Merck & Co., Inc., Kenilworth, NJ, USA).",2020,"Dysgeusia was the most common adverse event, occurring in three (5%) patients given placebo, six (10%) given 7·5 mg gefapixant, 21 (33%) given 20 mg gefapixant, and 30 (48%) given 50 mg gefapixant.
","['patients with refractory chronic cough or unexplained chronic cough aged 18-80 years who were recruited from 44 primarily outpatient pulmonologist or allergist sites in the UK and the USA', 'SD 9·9) years and 193 (76%) were women', 'patients with refractory chronic cough or unexplained chronic cough after 12 weeks of treatment compared with', 'mean age of patients was 60·2', 'Between Dec 21, 2015, and July 26, 2016, 253 patients', 'Eligible patients had refractory or unexplained chronic cough lasting 1 year or longer, no radiographic chest abnormality, and 40 mm or more on a 100-mm cough severity visual analogue scale at enrolment', 'refractory chronic cough or unexplained chronic cough']","['placebo', 'gefapixant', 'oral gefapixant', 'gefapixant 7·5 mg (n=64), gefapixant 20 mg (n=63), or gefapixant 50 mg']","['placebo-adjusted change from baseline in awake cough frequency', 'geometric mean awake cough frequency', 'cough frequency', 'Adverse events', 'Dysgeusia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4552486', 'cui_str': 'Refractory chronic cough'}, {'cui': 'C4552485', 'cui_str': 'Unexplained chronic cough'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0586859', 'cui_str': 'Pulmonologists'}, {'cui': 'C0334896', 'cui_str': 'Allergists'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}, {'cui': 'C0450402', 'cui_str': '40mm (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0234422', 'cui_str': 'Awake (finding)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0013378', 'cui_str': 'Taste, Distorted'}]",253.0,0.672719,"Dysgeusia was the most common adverse event, occurring in three (5%) patients given placebo, six (10%) given 7·5 mg gefapixant, 21 (33%) given 20 mg gefapixant, and 30 (48%) given 50 mg gefapixant.
","[{'ForeName': 'Jaclyn A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Division of Infection, Immunity, and Respiratory Medicine, University of Manchester, Manchester, UK; Manchester University NHS Foundation Trust, Manchester, UK. Electronic address: jacky.smith@manchester.ac.uk.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Kitt', 'Affiliation': 'Merck & Co., Kenilworth, NJ, USA.'}, {'ForeName': 'Alyn H', 'Initials': 'AH', 'LastName': 'Morice', 'Affiliation': 'Hull York Medical School, Cottingham, UK.'}, {'ForeName': 'Surinder S', 'Initials': 'SS', 'LastName': 'Birring', 'Affiliation': ""Centre for Human & Applied Physiological Sciences, School of Basic & Medical Biosciences, Faculty of Life Sciences & Medicine, King's College London, London, UK.""}, {'ForeName': 'Lorcan P', 'Initials': 'LP', 'LastName': 'McGarvey', 'Affiliation': ""Centre for Experimental Medicine, Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'Mandel R', 'Initials': 'MR', 'LastName': 'Sher', 'Affiliation': 'Center for Cough, Largo, FL, USA.'}, {'ForeName': 'Yu-Ping', 'Initials': 'YP', 'LastName': 'Li', 'Affiliation': 'GetStat Solutions, LLC, Palo Alto, CA, USA.'}, {'ForeName': 'Wen-Chi', 'Initials': 'WC', 'LastName': 'Wu', 'Affiliation': 'Merck & Co., Kenilworth, NJ, USA.'}, {'ForeName': 'Zhi Jin', 'Initials': 'ZJ', 'LastName': 'Xu', 'Affiliation': 'Merck & Co., Kenilworth, NJ, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Muccino', 'Affiliation': 'Merck & Co., Kenilworth, NJ, USA.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'Ford', 'Affiliation': 'Merck & Co., Kenilworth, NJ, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30471-0']
3186,30816637,"Sorafenib in Hepatopulmonary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.","The tyrosine kinase inhibitor sorafenib improves hepatopulmonary syndrome (HPS) in an experimental model. However, the efficacy and adverse effect profile in patients with HPS are unknown. We aimed to determine the effect of sorafenib on the alveolar-arterial oxygen gradient (AaPO 2  ) at 3 months in patients with HPS. We performed a randomized, double-blind, placebo-controlled parallel trial of sorafenib in patients with HPS at 7 centers. A total of 28 patients with HPS were randomized to sorafenib 400 mg by mouth daily or a matching placebo in a 1:1 ratio. We found no statistically significant difference in the median change in AaPO 2  from baseline to 12 weeks between the patients allocated to sorafenib (4.5 mm Hg; IQR, -3.8 to 7.0 mm Hg) and those allocated to placebo (-2.4 mm Hg; IQR, -4.8 to 8.2 mm Hg; P = 0.70). There was also no difference between the groups in terms of degree of intrapulmonary shunting by contrast echocardiography. Sorafenib significantly reduced circulating levels of angiogenic markers, including vascular endothelial growth factor receptors (P < 0.01) and TIE2-expressing M2 monocytes (P = 0.03), but it reduced the mental component scores of the Short Form 36 (P = 0.04), indicating a worse quality of life. In conclusion, sorafenib did not change the AaPO 2  or other disease markers at 3 months in patients with HPS. Alternative antiangiogenic therapies or treatments targeting other pathways should be investigated.",2019,"Sorafenib significantly reduced circulating levels of angiogenic markers, including vascular endothelial growth factor receptors (P < 0.01) and TIE2-expressing M2 monocytes (P = 0.03), but it reduced the mental component scores of the Short Form 36 (P = 0.04), indicating a worse quality of life.","['patients with HPS', '28 patients with HPS', 'Hepatopulmonary Syndrome', 'patients with HPS at 7\xa0centers']","['placebo', 'Sorafenib', 'Placebo', 'sorafenib 400\xa0mg by mouth daily or a matching placebo', 'sorafenib']","['median change in AaPO', 'degree of intrapulmonary shunting', 'circulating levels of angiogenic markers, including vascular endothelial growth factor receptors', 'quality of life', 'TIE2-expressing M2 monocytes', 'mental component scores', 'hepatopulmonary syndrome (HPS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600452', 'cui_str': 'Hepato-Pulmonary Syndrome'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1527415', 'cui_str': 'Per oral route'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0442121', 'cui_str': 'Intrapulmonary (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0148199', 'cui_str': 'VEGF Receptors'}, {'cui': 'C0034380'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600452', 'cui_str': 'Hepato-Pulmonary Syndrome'}]",28.0,0.566468,"Sorafenib significantly reduced circulating levels of angiogenic markers, including vascular endothelial growth factor receptors (P < 0.01) and TIE2-expressing M2 monocytes (P = 0.03), but it reduced the mental component scores of the Short Form 36 (P = 0.04), indicating a worse quality of life.","[{'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Kawut', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Ellenberg', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Krowka', 'Affiliation': 'Department of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldberg', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Vargas', 'Affiliation': 'Department of Medicine, Mayo Clinic, Phoenix, AZ.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Koch', 'Affiliation': 'Department of Medicine, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Sharkoski', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Al-Naamani', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Fox', 'Affiliation': 'Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Levitsky', 'Affiliation': 'Department of Medicine, Northwestern University, Chicago, IL.'}, {'ForeName': 'Jae K', 'Initials': 'JK', 'LastName': 'Oh', 'Affiliation': 'Department of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Lin', 'Affiliation': 'Department of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Nianfu', 'Initials': 'N', 'LastName': 'Song', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Mottram', 'Affiliation': 'Department of Medicine, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Margaret F', 'Initials': 'MF', 'LastName': 'Doyle', 'Affiliation': 'Department of Laboratory Medicine, University of Vermont School of Medicine, Burlington, VT.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kaplan', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Fallon', 'Affiliation': 'Department of Medicine, University of Arizona College of Medicine-Phoenix, Phoenix, AZ.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25438']
3187,30556959,"Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous Dose of Miridesap in Healthy Japanese Subjects.","This phase 1 study characterized the safety, tolerability, pharmacokinetics, and pharmacodynamics of miridesap (GSK2315698) following an intravenous (IV) infusion in healthy Japanese men. Subjects in Cohort 1 received 1-hour IV infusions of 10, 20, and 40 mg of miridesap or placebo, and subjects in Cohort 2 received a 15-hour IV infusion of 20 mg/h of miridesap or placebo. No treatment-related adverse events were reported. No new safety signals were identified for either vital signs or clinical laboratory parameters. A dose-dependent increase was observed in miridesap exposure (area under the concentration-time curve and maximum observed drug concentration) in the 10 to 40 mg/h dose range after a 1-hour IV infusion of miridesap. Rapid depletion of circulating serum amyloid P component was observed after the initiation of miridesap infusion. Serum amyloid P component concentrations fell in a dose-dependent manner following administration of miridesap.",2019,No treatment-related adverse events were reported.,"['Healthy Japanese Subjects', 'healthy Japanese men']","['15-hour IV infusion of 20\xa0mg/h of miridesap or placebo', 'miridesap or placebo']","['Serum amyloid P component concentrations', 'adverse events', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics', 'miridesap exposure (area under the concentration-time curve and maximum observed drug concentration', 'safety, tolerability, pharmacokinetics, and pharmacodynamics of miridesap (GSK2315698']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439421', 'cui_str': 'mg/h'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0002721', 'cui_str': 'Serum Amyloid P-Component'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",,0.109395,No treatment-related adverse events were reported.,"[{'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Ino', 'Affiliation': 'Medicines Development (Clinical Pharmacology Office), Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Doi', 'Affiliation': 'Medicines Development (Clinical Pharmacology Office), Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Liefaard', 'Affiliation': 'Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, Stevenage, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Cookson', 'Affiliation': 'GlaxoSmithKline Research and Development, Stevenage, UK.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Clinical Pharmacology Modelling and Simulation, GlaxoSmithKline, London, UK.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Itoh', 'Affiliation': 'Biomedical Data Sciences Department, Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan.'}, {'ForeName': 'Harue', 'Initials': 'H', 'LastName': 'Igarashi', 'Affiliation': 'Pre-Clinical Development, Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Nakano', 'Affiliation': 'Medicines Development, Japan Development Division, GlaxoSmithKline K.K., Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.631']
3188,32059974,Evaluation of axillary reverse mapping (ARM) in clinically axillary node negative breast cancer patients - Randomised controlled trial.,"BACKGROUND


Axillary lymph node dissection (ALND) is an important procedure for control of axillary nodal metastasis in breast cancer patients. Lymphedema, restriction of shoulder movement and axillary nodal recurrence are the most disabling complications of the procedure. Axillary reverse mapping (ARM) procedure for arm lymph node identification emerged as a step for their preservation during ALND. Here we are testing the effect of ARM on lymphedema development and whether it compromises oncological safety in early breast cancer patients.
PATIENTS AND METHODS


98 clinically node free breast cancer female patients undergoing completion ALND after positive sentinel lymph node biopsy were recruited in the study. They were put into group A (49 patients with ARM + ve preservation ALND) and group B (49 patients in the conventional ALND group). ARM procedure was performed in both groups, ARM positive nodes were preserved in group A, marked and taken out with other axillary LN in group B. The outcome was histopathology of ARM + ve LN, development of arm lymphedema, and restriction of shoulder movement on follow-up.
RESULTS


ARM was positive in 46 patients (93.8%) in group A and 43 patients (87.8%) in group B, ARM + ve LN revealed positive metastasis only in 1 patient (2.3%) in group B. Lymphedema developed in 3 (6.5% patients in group A and 9 patients (20.9%) in group B. Restriction of shoulder movement showed a non-significant difference between the two groups.
CONCLUSION


Axillary reverse mapping and preservation of arm lymphatics helped to decrease the lymphedema rate without compromising oncological safety in early breast cancer.",2020,"RESULTS


ARM was positive in 46 patients (93.8%) in group A and 43 patients (87.8%) in group B, ARM + ve LN revealed positive metastasis only in 1 patient (2.3%) in group B. Lymphedema developed in 3 (6.5% patients in group A and 9 patients (20.9%) in group B. Restriction of shoulder movement showed a non-significant difference between the two groups.
","['early breast cancer patients', 'clinically axillary node negative breast cancer patients', '98 clinically node free breast cancer female patients undergoing completion ALND after positive sentinel lymph node biopsy were recruited in the study', 'breast cancer patients']","['Axillary lymph node dissection (ALND', 'ARM\xa0+\xa0ve preservation ALND', 'ARM', 'axillary reverse mapping (ARM', 'Axillary reverse mapping ']","['histopathology of ARM\xa0+\xa0ve LN, development of arm lymphedema, and restriction of shoulder movement on follow-up', 'Lymphedema, restriction of shoulder movement and axillary nodal recurrence', 'Lymphedema', 'lymphedema rate', 'positive metastasis']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast (disorder)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0796693', 'cui_str': 'Sentinel Lymph Node Biopsy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}]","[{'cui': 'C0677043', 'cui_str': 'Histopathology (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0443268', 'cui_str': 'Nodal (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",98.0,0.0676695,"RESULTS


ARM was positive in 46 patients (93.8%) in group A and 43 patients (87.8%) in group B, ARM + ve LN revealed positive metastasis only in 1 patient (2.3%) in group B. Lymphedema developed in 3 (6.5% patients in group A and 9 patients (20.9%) in group B. Restriction of shoulder movement showed a non-significant difference between the two groups.
","[{'ForeName': 'Mohamed I', 'Initials': 'MI', 'LastName': 'Abdelhamid', 'Affiliation': 'Assistant Professor General Surgery, Zagazig University, 44519, Egypt. Electronic address: Dr_moh2003@yahoo.com.'}, {'ForeName': 'Amr Abdel', 'Initials': 'AA', 'LastName': 'Bari', 'Affiliation': 'Assistant Professor General Surgery, Zagazig University, 44519, Egypt. Electronic address: amrobaset@yahoo.com.'}, {'ForeName': 'Mohamed I', 'Initials': 'MI', 'LastName': 'Farid', 'Affiliation': 'Lecturer General Surgery, Zagazig University, 44519, Egypt. Electronic address: mohammad.fareed55@yahoo.com.'}, {'ForeName': 'Hazem', 'Initials': 'H', 'LastName': 'Nour', 'Affiliation': 'Assistant Professor General Surgery, Zagazig University, 44519, Egypt. Electronic address: Hzm_nr@yahoo.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.01.152']
3189,30753101,"Local and Systemic Immunity against Respiratory Syncytial Virus Induced by a Novel Intranasal Vaccine. A Randomized, Double-Blind, Placebo-controlled Clinical Trial.","Rationale:  Needle-free intranasal vaccines offer major potential advantages, especially against pathogens entering via mucosal surfaces. As yet, there is no effective vaccine against respiratory syncytial virus (RSV), a ubiquitous pathogen of global importance that preferentially infects respiratory epithelial cells; new strategies are urgently required. Objectives:  Here, we report the safety and immunogenicity of a novel mucosal RSV F protein vaccine linked to an immunostimulatory bacterium-like particle (BLP). Methods:  In this phase I, randomized, double-blind, placebo-controlled trial, 48 healthy volunteers, aged 18-49 years, were randomly assigned to receive placebo or SynGEM (low or high dose) intranasally by prime-boost administration. The primary outcome was safety and tolerability, with secondary objectives assessing virus-specific immunogenicity. Measurements and Main Results:  There were no significant differences in adverse events between placebo and vaccinated groups. SynGEM induced systemic plasmablast responses and significant, durable increases in RSV-specific serum antibody in healthy, seropositive adults. Volunteers given low-dose SynGEM (140 μg F, 2 mg BLP) required a boost at Day 28 to achieve plateau responses with a maximum fold change of 2.4, whereas high-dose recipients (350 μg F, 5 mg BLP) achieved plateau responses with a fold change of 1.5 after first vaccination that remained elevated up to 180 days after vaccination, irrespective of further boosting. Palivizumab-like antibodies were consistently induced, but F protein site ∅-specific antibodies were not detected, and virus-specific nasal IgA responses were heterogeneous, with the strongest responses in individuals with lower pre-existing antibody levels. Conclusions:  SynGEM is thus the first nonreplicating intranasal RSV subunit vaccine to induce persistent antibody responses in human volunteers.Clinical trials registered with www.clinicaltrials.gov (NCT02958540).",2019,"SynGEM induced systemic plasmablast responses and significant, durable increases in RSV-specific serum antibody in healthy seropositive adults.","['48 healthy volunteers aged 18-49 years', 'human volunteers', 'healthy seropositive adults']","['Intranasal Vaccine', 'placebo', 'placebo or SynGEM (low- or high-dose) intranasally by prime-boost administration', 'Placebo', 'novel mucosal RSV F protein vaccine']","['adverse events', 'safety and tolerability, with secondary objectives assessing virus-specific immunogenicity', 'systemic plasmablast responses', 'RSV-specific serum antibody']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0042776', 'cui_str': 'Virus'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0229657', 'cui_str': 'Plasmablast (cell)'}, {'cui': 'C0035236', 'cui_str': 'Respiratory syncytial virus'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",48.0,0.655855,"SynGEM induced systemic plasmablast responses and significant, durable increases in RSV-specific serum antibody in healthy seropositive adults.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Ascough', 'Affiliation': '1Section of Infectious Diseases and Immunity, Department of Medicine, and.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Vlachantoni', 'Affiliation': '2Section of Respiratory Infections, National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Kalyan', 'Affiliation': '1Section of Infectious Diseases and Immunity, Department of Medicine, and.'}, {'ForeName': 'Bert-Jan', 'Initials': 'BJ', 'LastName': 'Haijema', 'Affiliation': '3Mucosis B.V., represented by trustee Mr. Holtz, LLM, Bout Advocaten, Groningen, and Virtuvax B.V., Groningen, the Netherlands; and.'}, {'ForeName': 'Sanna', 'Initials': 'S', 'LastName': 'Wallin-Weber', 'Affiliation': '3Mucosis B.V., represented by trustee Mr. Holtz, LLM, Bout Advocaten, Groningen, and Virtuvax B.V., Groningen, the Netherlands; and.'}, {'ForeName': 'Margriet', 'Initials': 'M', 'LastName': 'Dijkstra-Tiekstra', 'Affiliation': '3Mucosis B.V., represented by trustee Mr. Holtz, LLM, Bout Advocaten, Groningen, and Virtuvax B.V., Groningen, the Netherlands; and.'}, {'ForeName': 'Muhammad S', 'Initials': 'MS', 'LastName': 'Ahmed', 'Affiliation': '4Department of Clinical Infection, Microbiology, and Immunology, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'van Roosmalen', 'Affiliation': '3Mucosis B.V., represented by trustee Mr. Holtz, LLM, Bout Advocaten, Groningen, and Virtuvax B.V., Groningen, the Netherlands; and.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Grimaldi', 'Affiliation': '3Mucosis B.V., represented by trustee Mr. Holtz, LLM, Bout Advocaten, Groningen, and Virtuvax B.V., Groningen, the Netherlands; and.'}, {'ForeName': 'Qibo', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': '4Department of Clinical Infection, Microbiology, and Immunology, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Leenhouts', 'Affiliation': '3Mucosis B.V., represented by trustee Mr. Holtz, LLM, Bout Advocaten, Groningen, and Virtuvax B.V., Groningen, the Netherlands; and.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Openshaw', 'Affiliation': '2Section of Respiratory Infections, National Heart and Lung Institute, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chiu', 'Affiliation': '1Section of Infectious Diseases and Immunity, Department of Medicine, and.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201810-1921OC']
3190,32111383,The effects of nurse-led health coaching on health-related quality of life and clinical health outcomes among frequent attenders: A quasi-experimental study.,"OBJECTIVE


To evaluate the effects of the nurse-led health coaching on health-related quality of life and clinical health outcomes among frequent attenders in primary healthcare.
METHODS


A quasi-experimental study design. A total of 110 patients were enrolled in the study. The experimental group (n = 52) received nurse-led health coaching and the control group (n = 58) received the usual care at primary health care centres in Finland. The data were collected before the intervention and 12 months via a questionnaire of health-related quality of life and clinical health outcomes as measured by health-coaching nurses.
RESULTS


This study found frequent attenders have low health-related quality of life. The nurse-led health coaching showed no differences in health-related quality of life between the experimental and control groups. However, the nurse-led health coaching had statistically significant effects on the blood pressure and health-related quality of life among the experimental participants, especially in emotional role limitation and energy.
CONCLUSIONS


This study suggests that nurse-led health coaching may lead to an improvement in the health-related quality of life and blood pressure among frequent attenders.
PRACTICE IMPLICATIONS


The health-coaching sessions with own health-coaching nurses and action plans support the frequent attenders´ health promotion goals and implementation.",2020,The nurse-led health coaching showed no differences in health-related quality of life between the experimental and control groups.,"['A total of 110 patients were enrolled in the study', 'frequent attenders', 'frequent attenders in primary healthcare']","['nurse-led health coaching', 'nurse-led health coaching and the control group (n\u202f=\u202f58) received the usual care at primary health care centres in Finland']","['health-related quality of life and clinical health outcomes', 'quality of life and clinical health outcomes', 'health-related quality of life', 'blood pressure and health-related quality of life']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0016132', 'cui_str': 'Finland'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",110.0,0.024312,The nurse-led health coaching showed no differences in health-related quality of life between the experimental and control groups.,"[{'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Kivelä', 'Affiliation': 'Research Unit of Nursing Science and Health Management, University of Oulu Finland University of Oulu, P.O.Box 5000, 90014, Finland. Electronic address: kirsi.kivela@dnainternet.net.'}, {'ForeName': 'Satu', 'Initials': 'S', 'LastName': 'Elo', 'Affiliation': 'Lapland University of Applied Sciences, Kemi, Finland. Electronic address: satu.elo@lapinamk.fi.'}, {'ForeName': 'Helvi', 'Initials': 'H', 'LastName': 'Kyngäs', 'Affiliation': 'University of Oulu University Hospital, Medical Research Center Oulu, Oulu, Finland. Electronic address: helvi.kyngas@oulu.fi.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kääriäinen', 'Affiliation': 'Research Unit of Nursing Science and Health Management, University of Oulu, Oulu University Hospital, Oulu, Finland. Electronic address: maria.kaariainen@oulu.fi.'}]",Patient education and counseling,['10.1016/j.pec.2020.02.026']
3191,30579673,Determinants and the Role of Self-Efficacy in a Sodium-Reduction Trial in Hemodialysis Patients.,"OBJECTIVE


This study was to assess the impact of baseline dietary self-efficacy on the effect of a dietary intervention to reduce sodium intake in patients undergoing hemodialysis (HD) and to identify determinants of low dietary self-efficacy.
METHODS


This is a post hoc analysis of the BalanceWise study, a randomized controlled trial that aimed to reduce dietary sodium intake in HD patients recruited from 17 dialysis centers in Pennsylvania. The main outcome measures include dietary self-efficacy and reported dietary sodium density. Analysis of variance with post hoc group-wise comparison was used to examine the effect of baseline dietary self-efficacy on changes in reported sodium density in the intervention and control groups at 8 and 16 weeks. Chi-square test, independent t tests, or Wilcoxon rank-sum tests were used to identify determinants of low dietary self-efficacy.
RESULTS


The interaction between dietary self-efficacy and the impact of the intervention on changes in reported dietary sodium density approached significance at 8 and 16 weeks (P interaction = 0.051 and 0.06, respectively). Younger age and perceived income inadequacy were significantly associated with low self-efficacy in patients undergoing HD.
CONCLUSION


The benefits of dietary interventions designed to improve self-efficacy may differ by the baseline self-efficacy status. This may be particularly important for HD patients who are younger and report inadequate income as they had lower dietary self-efficacy.",2019,"The interaction between dietary self-efficacy and the impact of the intervention on changes in reported dietary sodium density approached significance at 8 and 16 weeks (P interaction = 0.051 and 0.06, respectively).","['patients undergoing hemodialysis (HD', 'HD patients who are younger and report inadequate income', 'HD patients recruited from 17 dialysis centers in Pennsylvania', 'Hemodialysis Patients']",['dietary intervention'],"['self-efficacy', 'dietary self-efficacy and reported dietary sodium density']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]",[],"[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037570', 'cui_str': 'Sodium, Dietary'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",,0.0354234,"The interaction between dietary self-efficacy and the impact of the intervention on changes in reported dietary sodium density approached significance at 8 and 16 weeks (P interaction = 0.051 and 0.06, respectively).","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'New York University School of Medicine, Center for Healthful Behavior Change, New York, New York. Electronic address: lu.hu@nyumc.org.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'St-Jules', 'Affiliation': 'New York University School of Medicine, Center for Healthful Behavior Change, New York, New York.'}, {'ForeName': 'Collin J', 'Initials': 'CJ', 'LastName': 'Popp', 'Affiliation': 'New York University School of Medicine, Center for Healthful Behavior Change, New York, New York.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Sevick', 'Affiliation': 'New York University School of Medicine, Center for Healthful Behavior Change, New York, New York.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2018.10.006']
3192,31915255,GABA-ergic Dynamics in Human Frontotemporal Networks Confirmed by Pharmaco-Magnetoencephalography.,"To bridge the gap between preclinical cellular models of disease and  in vivo  imaging of human cognitive network dynamics, there is a pressing need for informative biophysical models. Here we assess dynamic causal models (DCM) of cortical network responses, as generative models of magnetoencephalographic observations during an auditory oddball roving paradigm in healthy adults. This paradigm induces robust perturbations that permeate frontotemporal networks, including an evoked 'mismatch negativity' response and transiently induced oscillations. Here, we probe GABAergic influences in the networks using double-blind placebo-controlled randomized-crossover administration of the GABA reuptake inhibitor, tiagabine (oral, 10 mg) in healthy older adults. We demonstrate the facility of conductance-based neural mass mean-field models, incorporating local synaptic connectivity, to investigate laminar-specific and GABAergic mechanisms of the auditory response. The neuronal model accurately recapitulated the observed magnetoencephalographic data. Using parametric empirical Bayes for optimal model inversion across both drug sessions, we identify the effect of tiagabine on GABAergic modulation of deep pyramidal and interneuronal cell populations. We found a transition of the main GABAergic drug effects from auditory cortex in standard trials to prefrontal cortex in deviant trials. The successful integration of pharmaco- magnetoencephalography with dynamic causal models of frontotemporal networks provides a potential platform on which to evaluate the effects of disease and pharmacological interventions. SIGNIFICANCE STATEMENT  Understanding human brain function and developing new treatments require good models of brain function. We tested a detailed generative model of cortical microcircuits that accurately reproduced human magnetoencephalography, to quantify network dynamics and connectivity in frontotemporal cortex. This approach identified the effect of a test drug (GABA-reuptake inhibitor, tiagabine) on neuronal function (GABA-ergic dynamics), opening the way for psychopharmacological studies in health and disease with the mechanistic precision afforded by generative models of the brain.",2020,We found a transition of the main GABAergic drug effects from auditory cortex in standard trials to prefrontal cortex in deviant trials.,"['healthy adults', 'healthy older adults']","['test drug (GABA-reuptake inhibitor, tiagabine', 'auditory oddball roving paradigm', 'placebo', 'tiagabine', 'GABA re-uptake inhibitor, tiagabine (oral']",[],"[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2936508', 'cui_str': 'Uptake Inhibitors, Gamma-Aminobutyric Acid'}, {'cui': 'C0068897', 'cui_str': 'tiagabine'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",[],,0.0641366,We found a transition of the main GABAergic drug effects from auditory cortex in standard trials to prefrontal cortex in deviant trials.,"[{'ForeName': 'Natalie E', 'Initials': 'NE', 'LastName': 'Adams', 'Affiliation': 'Cambridge University Department of Clinical Neurosciences and Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, CB2 0SZ, United Kingdom.'}, {'ForeName': 'Laura E', 'Initials': 'LE', 'LastName': 'Hughes', 'Affiliation': 'Cambridge University Department of Clinical Neurosciences and Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, CB2 0SZ, United Kingdom.'}, {'ForeName': 'Holly N', 'Initials': 'HN', 'LastName': 'Phillips', 'Affiliation': 'Cambridge University Department of Clinical Neurosciences and Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, CB2 0SZ, United Kingdom.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Shaw', 'Affiliation': 'Cambridge University Department of Clinical Neurosciences and Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, CB2 0SZ, United Kingdom.'}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Murley', 'Affiliation': 'Cambridge University Department of Clinical Neurosciences and Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, CB2 0SZ, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nesbitt', 'Affiliation': 'Medical Research Council Cognition and Brain Sciences Unit, Cambridge CB2 7EF, United Kingdom, and.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Cope', 'Affiliation': 'Cambridge University Department of Clinical Neurosciences and Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, CB2 0SZ, United Kingdom.'}, {'ForeName': 'W Richard', 'Initials': 'WR', 'LastName': 'Bevan-Jones', 'Affiliation': 'Cambridge University Department of Clinical Neurosciences and Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, CB2 0SZ, United Kingdom.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Passamonti', 'Affiliation': 'Cambridge University Department of Clinical Neurosciences and Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, CB2 0SZ, United Kingdom.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Rowe', 'Affiliation': 'Cambridge University Department of Clinical Neurosciences and Cambridge University Hospitals NHS Foundation Trust, Cambridge Biomedical Campus, Cambridge, CB2 0SZ, United Kingdom, james.rowe@mrc-cbu.cam.ac.uk.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.1689-19.2019']
3193,31377692,Home-based rehabilitation for heart failure with reduced ejection fraction: mixed methods process evaluation of the REACH-HF multicentre randomised controlled trial.,"OBJECTIVE


To identify and explore change processes explaining the effects of the Rehabilitation Enablement in Chronic Heart Failure (REACH-HF) intervention taking account of reach, amount of intervention received, delivery fidelity and patient and caregiver perspectives.
DESIGN


Mixed methods process evaluation parallel to a randomised controlled trial using data from the intervention group (REACH-HF plus usual care).
SETTING


Four centres in the UK (Birmingham, Cornwall, Gwent and York).
PARTICIPANTS


People with heart failure with reduced ejection fraction (HFrEF) and their caregivers.
METHODS


The REACH-HF intervention consisted of a self-help manual for patients with HFrEF and caregivers facilitated over 12 weeks by trained healthcare professionals. The process evaluation used multimodal mixed methods analysis. Data consisted of audio recorded intervention sessions; demographic data; intervention fidelity scores for intervention group participants (107 patients and 53 caregivers); qualitative interviews at 4 and 12 months with a sample of 19 patients and 17 caregivers.
OUTCOME MEASURES


Quantitative data: intervention fidelity and number, frequency and duration of intervention sessions received. Qualitative data: experiences and perspectives of intervention participants and caregivers.
RESULTS


Intervention session attendance with facilitators was high. Fidelity scores were indicative of adequate quality of REACH-HF intervention delivery, although indicating scope for improvement in several areas. Intervention effectiveness was contingent on matching the intervention implementation to the concerns, beliefs and goals of participants. Behaviour change was sustained when shared meaning was established. Respondents' comorbidities, socio-economic circumstances and existing networks of support also affected changes in health-related quality of life.
CONCLUSIONS


By combining longitudinal mixed methods data, the essential ingredients of complex interventions can be better identified, interrogated and tested. This can maximise the clinical application of research findings and enhance the capacity of multidisciplinary and multisite teams to implement the intervention.
TRIAL REGISTRATION NUMBER


ISRCTN25032672; Pre-results.",2019,"Respondents' comorbidities, socio-economic circumstances and existing networks of support also affected changes in health-related quality of life.
","['heart failure with reduced ejection fraction', 'Four centres in the UK (Birmingham, Cornwall, Gwent and York', 'People with heart failure with reduced ejection fraction (HFrEF) and their caregivers', 'intervention group participants (107 patients and 53 caregivers); qualitative interviews at 4 and 12 months with a sample of 19 patients and 17 caregivers']","['Home-based rehabilitation', 'intervention group (REACH-HF plus usual care']","['Behaviour change', 'Fidelity scores']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454846', 'cui_str': 'Cornwall (geographic location)'}, {'cui': 'C0454944', 'cui_str': 'Gwent (geographic location)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",107.0,0.0923526,"Respondents' comorbidities, socio-economic circumstances and existing networks of support also affected changes in health-related quality of life.
","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Frost', 'Affiliation': 'Institute of Health Research, University of Exeter, Exeter, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wingham', 'Affiliation': 'Primary Care Research Group, University of Exeter, Exeter, UK.'}, {'ForeName': 'Nicky', 'Initials': 'N', 'LastName': 'Britten', 'Affiliation': 'Institute of Health Research, University of Exeter, Exeter, UK.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Greaves', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Abraham', 'Affiliation': 'School of Pscyhological Sciences, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Fiona C', 'Initials': 'FC', 'LastName': 'Warren', 'Affiliation': 'Collaboration for Academic Primary Care, University of Exeter, Exeter, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'University of Birmingham, Institute of Applied Health Research, Birmingham, UK.'}, {'ForeName': 'Patrick Joseph', 'Initials': 'PJ', 'LastName': 'Doherty', 'Affiliation': 'Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Miles', 'Affiliation': 'Department of innovation and Research, Aneurin Bevan Health Board, Newport, UK.'}, {'ForeName': 'Sally J', 'Initials': 'SJ', 'LastName': 'Singh', 'Affiliation': 'Centre for Exercise and Rehabilitation Science, University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Paul', 'Affiliation': 'Patient and Public Involvement Group, Royal Cornwall Hospitals NHS Trust, Truro, UK.'}, {'ForeName': 'Rod', 'Initials': 'R', 'LastName': 'Taylor', 'Affiliation': 'Institute of Health Research, University of Exeter, Exeter, UK.'}, {'ForeName': 'Hasnain', 'Initials': 'H', 'LastName': 'Dalal', 'Affiliation': 'Teaching and Research, Royal Cornwall Hospitals NHS Trust, Truro, UK.'}]",BMJ open,['10.1136/bmjopen-2018-026039']
3194,30804464,Association of orthostatic hypertension with mortality in the Systolic Hypertension in the Elderly Program.,"We examined the association of orthostatic hypertension with all-cause mortality in the active treatment and placebo randomized groups of the Systolic Hypertension in the Elderly Program (SHEP). SHEP was a multicenter, randomized, double-blind, placebo-controlled clinical trial of the effect of chlorthalidone-based antihypertensive treatment on the rate of occurrence of stroke among older persons with isolated systolic hypertension (ISH). Men and women aged 60 years and above with ISH defined by a systolic blood pressure (SBP) of 160 mm Hg or higher and diastolic blood pressure lower than 90 mm Hg were randomized to chlorthalidone-based stepped care therapy or matching placebo. Among 4736 SHEP participants, 4073 had a normal orthostatic response, 203 had orthostatic hypertension, and 438 had orthostatic hypotension. Compared with normal response, orthostatic hypertension was associated with higher all-cause mortality at 4.5 and 17 years in analyses adjusted for age, gender, treatment, SBP, and pulse pressure (PP, HR 1.87, 95% CI 1.30-2.69, p = 0.0007; HR 1.40, 95% CI 1.17-1.68, p = 0.0003, respectively). These associations remained significant after additional adjustment for risk factors and comorbidities (HR 1.43, 95% CI 0.99-0.08, p = 0.0566 at 4.5 years, and HR 1.27, 95% CI 1.06-1.53, p = 0.0096 at 17 years). The increased risk of all-cause mortality associated with orthostatic hypertension was observed in both the active and placebo groups without significant interaction between randomization group and the effect on mortality. Orthostatic hypertension is associated with future mortality risk, is easily detected, and can be used in refining cardiovascular risk assessment.",2019,"Compared with normal response, orthostatic hypertension was associated with higher all-cause mortality at 4.5 and 17 years in analyses adjusted for age, gender, treatment, SBP, and pulse pressure (PP, HR 1.87, 95% CI 1.30-2.69, p = 0.0007; HR 1.40, 95% CI 1.17-1.68, p = 0.0003, respectively).","['randomized groups of the Systolic Hypertension in the Elderly Program (SHEP', 'Men and women aged 60 years and above with ISH defined by a systolic blood pressure (SBP) of 160\u2009mm Hg or higher and diastolic blood pressure lower than 90\u2009mm Hg', '4736 SHEP participants, 4073 had a normal orthostatic response, 203 had orthostatic hypertension, and 438 had orthostatic hypotension', 'older persons with isolated systolic hypertension (ISH']","['SHEP', 'chlorthalidone-based antihypertensive treatment', 'chlorthalidone-based stepped care therapy or matching placebo', 'placebo']","['Orthostatic hypertension', 'orthostatic hypertension', 'SBP, and pulse pressure', 'rate of occurrence of stroke', 'mortality']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0221155', 'cui_str': 'Systolic hypertension (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0544618', 'cui_str': 'Orthostatic hypertension'}, {'cui': 'C0020651', 'cui_str': 'Hypotension, Postural'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0745133', 'cui_str': 'Isolated systolic hypertension'}]","[{'cui': 'C0008294', 'cui_str': 'Chlorthalidone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0544618', 'cui_str': 'Orthostatic hypertension'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",4736.0,0.348896,"Compared with normal response, orthostatic hypertension was associated with higher all-cause mortality at 4.5 and 17 years in analyses adjusted for age, gender, treatment, SBP, and pulse pressure (PP, HR 1.87, 95% CI 1.30-2.69, p = 0.0007; HR 1.40, 95% CI 1.17-1.68, p = 0.0003, respectively).","[{'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Kostis', 'Affiliation': 'Cardiovascular Institute, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA. wkostis@rutgers.edu.'}, {'ForeName': 'Davit', 'Initials': 'D', 'LastName': 'Sargsyan', 'Affiliation': 'Cardiovascular Institute, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Choukri', 'Initials': 'C', 'LastName': 'Mekkaoui', 'Affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Abel E', 'Initials': 'AE', 'LastName': 'Moreyra', 'Affiliation': 'Cardiovascular Institute, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cabrera', 'Affiliation': 'Cardiovascular Institute, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Nora M', 'Initials': 'NM', 'LastName': 'Cosgrove', 'Affiliation': 'Cardiovascular Institute, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Jeanine E', 'Initials': 'JE', 'LastName': 'Sedjro', 'Affiliation': 'Cardiovascular Institute, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Kostis', 'Affiliation': 'Cardiovascular Institute, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Memphis Veterans Affairs Medical Center, Memphis, TN, USA.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Pantazopoulos', 'Affiliation': 'Cardiovascular Institute, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Pressel', 'Affiliation': 'University of Texas Health Science Center, Houston, TX, USA.'}, {'ForeName': 'Barry R', 'Initials': 'BR', 'LastName': 'Davis', 'Affiliation': 'University of Texas Health Science Center, Houston, TX, USA.'}]",Journal of human hypertension,['10.1038/s41371-019-0180-4']
3195,31067010,Impact of preprocedural TIMI flow on clinical outcome in low-risk patients with ST-elevation myocardial infarction: Results from the ATLANTIC study.,"OBJECTIVES


This study sought to analyze the impact of the preprocedural thrombolysis in myocardial infarction (TIMI) flow on clinical outcome in patients with ST-elevation myocardial infarction (STEMI).
BACKGROUND


Previous studies have shown that the TIMI flow 0/1 prior to primary percutaneous coronary intervention (PCI) is associated with a poor clinical outcome. However, it is unclear whether the same is true in patients with ongoing STEMI of less than 6 hr duration, rapid reperfusion, and modern guideline-adherent therapy.
METHODS


The ATLANTIC study compared prehospital versus inhospital treatment with ticagrelor in patients with acute STEMI. For this analysis, patients were divided into three groups according to the preprocedural TIMI flow grade of the infarct vessel: TIMI 0/1, TIMI 2, and TIMI 3.
RESULTS


From a total of 1,680 patients, 1,113 had TIMI 0/1, 279 TIMI 2, and 288 TIMI 3 flow before primary PCI. At 30 days, the composite ischemic endpoint (5.5, 2.9, and 2.1%, p < .05) and all-cause death (3.0, 1.4, and 2.1%, p = .30) were highest in patients with TIMI flow 0/1. After adjustment, preprocedural TIMI flow <3 (versus 3) was not an independent predictor of major adverse ischemic events within 30 days (odds ratio 1.89, 95% confidence interval 0.74-4.85). However, definite stent thrombosis occurred only in patients with initial TIMI flow 0/1 (1.0%). Among these patients, those with prehospital administration of ticagrelor were less often affected (0.3% vs. 1.3%, p < .05).
CONCLUSION


In this post-hoc analysis, preprocedural TIMI flow was not independently associated with a higher rate of adverse ischemic events.",2020,"However, definite stent thrombosis occurred only in patients with initial TIMI flow 0/1 (1.0%).","['patients with ongoing STEMI of less than 6\u2009hr duration, rapid reperfusion, and modern guideline-adherent therapy', 'From a total of 1,680 patients, 1,113 had TIMI 0/1, 279 TIMI 2, and 288 TIMI 3 flow before primary PCI', 'patients with acute STEMI', 'low-risk patients with ST-elevation myocardial infarction', 'patients with ST-elevation myocardial infarction (STEMI']","['preprocedural TIMI flow', 'ticagrelor']","['stent thrombosis', 'major adverse ischemic events', 'preprocedural TIMI flow <3', 'adverse ischemic events', 'composite ischemic endpoint', 'preprocedural TIMI flow', 'cause death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1680.0,0.0338413,"However, definite stent thrombosis occurred only in patients with initial TIMI flow 0/1 (1.0%).","[{'ForeName': 'Timm', 'Initials': 'T', 'LastName': 'Bauer', 'Affiliation': 'Department of Cardiology, University Clinic Giessen, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Department of Cardiology, Heart Center Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Abdourahmane', 'Initials': 'A', 'LastName': 'Diallo', 'Affiliation': 'Unite de Recherche Clinique, Hôpital Lariboisière, ACTION Study Group, Université Paris 7, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Unite de Recherche Clinique, Hôpital Lariboisière, ACTION Study Group, Université Paris 7, Paris, France.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bolognese', 'Affiliation': 'Cardiovascular and Neurological Department, Azienda Ospedaliera Arezzo, Arezzo, Italy.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Cequier', 'Affiliation': ""Heart Disease Institute, Hospital Universitario de Bellvitge, University of Barcelona, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': '3rd Department of Medicine, Cardiology and Intensive Care Medicine, Wilhelminen Hospital, and Sigmund Freud Private University, Medical School, Vienna, Austria.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, Institut de Cardiologie (AP-HP), Centre Hospitalier Universitaire Pitié-Salpêtrière, Paris, France.'}, {'ForeName': 'Christian W', 'Initials': 'CW', 'LastName': 'Hamm', 'Affiliation': 'Department of Cardiology, University Clinic Giessen, Germany.'}, {'ForeName': 'Arnoud W', 'Initials': 'AW', 'LastName': ""Van't Hof"", 'Affiliation': 'Department of Interventional Cardiology, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28318']
3196,30508552,"Screening initiation with FIT or colonoscopy: Post-hoc analysis of a pragmatic, randomized trial.","Screening with FIT or colonoscopy can reduce CRC mortality. In our pragmatic, randomized trial of screening outreach over three years, patients annually received mailed FITs or colonoscopy invitations. We examined screening initiation after each mailing and crossover from the invited to other modality. Eligible patients (50-64 years, ≥1 primary-care visit before randomization, and no history of CRC) received mailed FIT kits (n = 2400) or colonoscopy invitations (n = 2400) from March 2013 through July 2016. Among those invited for colonoscopy, we used multinomial logistic regression to identify factors associated with screening initiation with colonoscopy vs. FIT vs. no screening after the first mailing. Most patients were female (61.8%) and Hispanic (48.9%) or non-Hispanic black (24.0%). Among those invited for FIT, 56.6% (n = 1359) initiated with FIT, whereas 3.3% (n = 78) crossed over to colonoscopy; 151 (15.7%) and 61 (7.7%) initiated with FIT after second and third mailings. Among those invited for colonoscopy, 25.5% (n = 613) initiated with colonoscopy whereas 18.8% (n = 452) crossed over to FIT; 112 (8.4%) and 48 (4.2%) initiated with colonoscopy after second and third mailings. Three or more primary-care visits prior to randomization were associated with initiating with colonoscopy (OR 1.49, 95% CI 1.17-1.91) and crossing over to FIT (OR 1.63, 95% CI 1.19-2.23). Although nearly half of patients initiated screening after the first mailing, few non-responders in either outreach group initiated after a second or third mailing. More patients invited to colonoscopy crossed over to FIT than those assigned to FIT crossed over to colonoscopy.",2019,"Three or more primary-care visits prior to randomization were associated with initiating with colonoscopy (OR 1.49, 95% CI 1.17-1.91) and crossing over to FIT (OR 1.63, 95% CI 1.19-2.23).","['Most patients were female (61.8%) and Hispanic (48.9%) or non-Hispanic black (24.0', 'Eligible patients (50-64\u202fyears, ≥1 primary-care visit before randomization, and no history of CRC) received']","['mailed FIT kits (n\u202f=\u202f2400) or colonoscopy invitations', 'mailed FITs or colonoscopy invitations']",['CRC mortality'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C4517656', 'cui_str': 'Two thousand four hundred'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0283756,"Three or more primary-care visits prior to randomization were associated with initiating with colonoscopy (OR 1.49, 95% CI 1.17-1.91) and crossing over to FIT (OR 1.63, 95% CI 1.19-2.23).","[{'ForeName': 'Caitlin C', 'Initials': 'CC', 'LastName': 'Murphy', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Harold C. Simmons Comprehensive Cancer Center, Dallas, TX, United States of America; Department of Medicine, UC San Diego Medical Center, San Diego, CA, United States of America; Veterans Affairs San Diego Healthcare System, San Diego, CA, United States of America. Electronic address: caitlin.murphy@utsouthwestern.edu.'}, {'ForeName': 'Chul', 'Initials': 'C', 'LastName': 'Ahn', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Harold C. Simmons Comprehensive Cancer Center, Dallas, TX, United States of America; Department of Medicine, UC San Diego Medical Center, San Diego, CA, United States of America; Veterans Affairs San Diego Healthcare System, San Diego, CA, United States of America.'}, {'ForeName': 'Sandi L', 'Initials': 'SL', 'LastName': 'Pruitt', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Harold C. Simmons Comprehensive Cancer Center, Dallas, TX, United States of America; Department of Medicine, UC San Diego Medical Center, San Diego, CA, United States of America; Veterans Affairs San Diego Healthcare System, San Diego, CA, United States of America.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Hughes', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Harold C. Simmons Comprehensive Cancer Center, Dallas, TX, United States of America; Department of Medicine, UC San Diego Medical Center, San Diego, CA, United States of America; Veterans Affairs San Diego Healthcare System, San Diego, CA, United States of America.'}, {'ForeName': 'Ethan A', 'Initials': 'EA', 'LastName': 'Halm', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Harold C. Simmons Comprehensive Cancer Center, Dallas, TX, United States of America; Department of Medicine, UC San Diego Medical Center, San Diego, CA, United States of America; Veterans Affairs San Diego Healthcare System, San Diego, CA, United States of America.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Harold C. Simmons Comprehensive Cancer Center, Dallas, TX, United States of America; Department of Medicine, UC San Diego Medical Center, San Diego, CA, United States of America; Veterans Affairs San Diego Healthcare System, San Diego, CA, United States of America.'}, {'ForeName': 'Noel O', 'Initials': 'NO', 'LastName': 'Santini', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Harold C. Simmons Comprehensive Cancer Center, Dallas, TX, United States of America; Department of Medicine, UC San Diego Medical Center, San Diego, CA, United States of America; Veterans Affairs San Diego Healthcare System, San Diego, CA, United States of America.'}, {'ForeName': 'Katharine', 'Initials': 'K', 'LastName': 'McCallister', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Harold C. Simmons Comprehensive Cancer Center, Dallas, TX, United States of America; Department of Medicine, UC San Diego Medical Center, San Diego, CA, United States of America; Veterans Affairs San Diego Healthcare System, San Diego, CA, United States of America.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Sanders', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Harold C. Simmons Comprehensive Cancer Center, Dallas, TX, United States of America; Department of Medicine, UC San Diego Medical Center, San Diego, CA, United States of America; Veterans Affairs San Diego Healthcare System, San Diego, CA, United States of America.'}, {'ForeName': 'Amit G', 'Initials': 'AG', 'LastName': 'Singal', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Harold C. Simmons Comprehensive Cancer Center, Dallas, TX, United States of America; Department of Medicine, UC San Diego Medical Center, San Diego, CA, United States of America; Veterans Affairs San Diego Healthcare System, San Diego, CA, United States of America.'}, {'ForeName': 'Celette Sugg', 'Initials': 'CS', 'LastName': 'Skinner', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, United States of America; Harold C. Simmons Comprehensive Cancer Center, Dallas, TX, United States of America; Department of Medicine, UC San Diego Medical Center, San Diego, CA, United States of America; Veterans Affairs San Diego Healthcare System, San Diego, CA, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2018.11.020']
3197,30770436,Randomised controlled trial of real-time feedback and brief coaching to reduce indoor smoking.,"BACKGROUND


Previous secondhand smoke (SHS) reduction interventions have provided only  delayed  feedback on reported smoking behaviour, such as coaching, or presenting results from child cotinine assays or air particle counters.
DESIGN


This SHS reduction trial assigned families at random to brief coaching and continuous real-time feedback (intervention) or measurement-only (control) groups.
PARTICIPANTS


We enrolled 298 families with a resident tobacco smoker and a child under age 14.
INTERVENTION


We installed air particle monitors in all homes. For the intervention homes,  immediate  light and sound feedback was contingent on elevated indoor particle levels, and up to four coaching sessions used prompts and praise contingent on smoking outdoors. Mean intervention duration was 64 days.
MEASURES


The primary outcome was 'particle events' (PEs) which were patterns of air particle concentrations indicative of the occurrence of particle-generating behaviours such as smoking cigarettes or burning candles. Other measures included indoor air nicotine concentrations and participant reports of particle-generating behaviour.
RESULTS


PEs were significantly correlated with air nicotine levels (r=0.60) and reported indoor cigarette smoking (r=0.51). Interrupted time-series analyses showed an immediate intervention effect, with reduced PEs the day following intervention initiation. The trajectory of daily PEs over the intervention period declined significantly faster in intervention homes than in control homes. Pretest to post-test, air nicotine levels, cigarette smoking and e-cigarette use decreased more in intervention homes than in control homes.
CONCLUSIONS


Results suggest that real-time particle feedback and coaching contingencies reduced PEs generated by cigarette smoking and other sources.
TRIAL REGISTRATION NUMBER


NCT01634334; Post-results.",2020,"Pretest to post-test, air nicotine levels, cigarette smoking and e-cigarette use decreased more in intervention homes than in control homes.
",['We enrolled 298 families with a resident tobacco smoker and a child under age 14'],"['real-time feedback and brief coaching', 'brief coaching and continuous real-time feedback (intervention) or measurement-only (control) groups', 'secondhand smoke (SHS) reduction interventions']","['indoor air nicotine concentrations and participant reports of particle-generating behaviour', ""particle events' (PEs) which were patterns of air particle concentrations indicative of the occurrence of particle-generating behaviours such as smoking cigarettes or burning candles"", 'air nicotine levels', 'indoor cigarette smoking', 'Mean intervention duration', 'indoor smoking', 'Pretest to post-test, air nicotine levels, cigarette smoking and e-cigarette use']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4505217', 'cui_str': 'Smokers, Tobacco'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037370', 'cui_str': 'Smoking, Passive'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4280017', 'cui_str': 'E-Cig Use'}]",298.0,0.025272,"Pretest to post-test, air nicotine levels, cigarette smoking and e-cigarette use decreased more in intervention homes than in control homes.
","[{'ForeName': 'Melbourne F', 'Initials': 'MF', 'LastName': 'Hovell', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Bellettiere', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Liles', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Nguyen', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Berardi', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Johnson', 'Affiliation': 'Pediatrics, Naval Medical Center, San Diego, California, USA.'}, {'ForeName': 'Georg E', 'Initials': 'GE', 'LastName': 'Matt', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Malone', 'Affiliation': 'Department of Medicine, F Edward Hebert School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.'}, {'ForeName': 'Marie C', 'Initials': 'MC', 'LastName': 'Boman-Davis', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Penelope J E', 'Initials': 'PJE', 'LastName': 'Quintana', 'Affiliation': 'Environmental Health, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Saori', 'Initials': 'S', 'LastName': 'Obayashi', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Chatfield', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Robinson', 'Affiliation': 'Office on Smoking and Health, CDC, Atlanta, Georgia, USA.'}, {'ForeName': 'Elaine J', 'Initials': 'EJ', 'LastName': 'Blumberg', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Weg M', 'Initials': 'WM', 'LastName': 'Ongkeko', 'Affiliation': 'Surgery, University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Neil E', 'Initials': 'NE', 'LastName': 'Klepeis', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University, San Diego, California, USA.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Hughes', 'Affiliation': 'Center for Behavioral Epidemiology and Community Health, Graduate School of Public Health, San Diego State University, San Diego, California, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Tobacco control,['10.1136/tobaccocontrol-2018-054717']
3198,31821109,NSABP B-47/NRG Oncology Phase III Randomized Trial Comparing Adjuvant Chemotherapy With or Without Trastuzumab in High-Risk Invasive Breast Cancer Negative for HER2 by FISH and With IHC 1+ or 2.,"PURPOSE


Adjuvant trastuzumab reduces invasive breast cancer (IBC) recurrence and risk for death in patients with HER2-amplified or overexpressing IBC. A subset of patients in the landmark trastuzumab adjuvant trials who originally tested HER2-positive but were HER2-negative by central HER2 testing appeared to possibly benefit from trastuzumab. The objective for the NSABP B-47 trial was to determine whether the addition of trastuzumab to adjuvant chemotherapy (CRx) would improve invasive disease-free survival (IDFS) in patients with HER2-negative breast cancer.
PATIENTS AND METHODS


A total of 3,270 women with high-risk primary IBC were randomly assigned to CRx with or without 1 year of trastuzumab. Eligibility criteria included immunohistochemistry (IHC) score 1+ or 2+ with fluorescence in situ hybridization ratio (FISH) < 2.0 or, if ratio was not performed, HER2 gene copy number < 4.0. CRx was either docetaxel plus cyclophosphamide or doxorubicin and cyclophosphamide followed by weekly paclitaxel for 12 weeks.
RESULTS


At a median follow-up of 46 months, the addition of trastuzumab to CRx did not improve IDFS (5-year IDFS: 89.8% with CRx plus trastuzumab [CRxT]  v  89.2% with CRx alone; hazard ratio [HR], 0.98; 95% CI, 0.76 to 1.25;  P  = .85). These findings did not differ by level of HER2 IHC expression, lymph node involvement, or hormone-receptor status. For distant recurrence-free interval, 5-year estimates were 92.7% with CRxT compared with 93.6% for CRx alone (HR, 1.10; 95% CI, 0.81 to 1.50;  P  = .55) and for overall survival (OS) were 94.8% with CRxT and 96.3% in CRx alone (HR, 1.33; 95% CI, 0.90 to 1.95;  P  = .15). There were no unexpected toxicities from the addition of trastuzumab to CRx.
CONCLUSION


The addition of trastuzumab to CRx did not improve IDFS, distant recurrence-free interval, or OS in women with non-HER2-overexpressing IBC. Trastuzumab does not benefit women without IHC 3+ or FISH ratio-amplified breast cancer.",2020,"The addition of trastuzumab to CRx did not improve IDFS, distant recurrence-free interval, or OS in women with non-HER2-overexpressing IBC.","['3,270 women with high-risk primary IBC', 'patients with HER2-negative breast cancer', 'patients with HER2-amplified or overexpressing IBC']","['trastuzumab to adjuvant chemotherapy (CRx', 'Adjuvant Chemotherapy', 'CRx with or without 1 year of trastuzumab', 'CRx plus trastuzumab [CRxT', 'Trastuzumab', 'docetaxel plus cyclophosphamide or doxorubicin and cyclophosphamide', 'trastuzumab']","['IDFS, distant recurrence-free interval, or OS', 'invasive disease-free survival (IDFS', 'level of HER2 IHC expression, lymph node involvement, or hormone-receptor status', 'toxicities', 'IDFS ', 'distant recurrence-free interval, 5-year estimates', '5-year IDFS', 'overall survival (OS', 'invasive breast cancer (IBC) recurrence and risk for death']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}]","[{'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0449443', 'cui_str': 'Receptor status (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",3270.0,0.231243,"The addition of trastuzumab to CRx did not improve IDFS, distant recurrence-free interval, or OS in women with non-HER2-overexpressing IBC.","[{'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Fehrenbacher', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Reena S', 'Initials': 'RS', 'LastName': 'Cecchini', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Costantino', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Atkins', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Crown', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Polikoff', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Boileau', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Provencher', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Stokoe', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Timothy D', 'Initials': 'TD', 'LastName': 'Moore', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Robidoux', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Flynn', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Virginia F', 'Initials': 'VF', 'LastName': 'Borges', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Kathy S', 'Initials': 'KS', 'LastName': 'Albain', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Swain', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Soonmyung', 'Initials': 'S', 'LastName': 'Paik', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Eleftherios P', 'Initials': 'EP', 'LastName': 'Mamounas', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NRG Oncology, Pittsburgh, PA.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01455']
3199,30234850,Pharmaco-fMRI in Patients With Traumatic Brain Injury: A Randomized Controlled Trial With the Monoaminergic Stabilizer (-)-OSU6162.,"OBJECTIVE


To examine the effects of monoaminergic stabilizer (-)-OSU6162 on brain activity, as measured by blood-oxygen-level-dependent (BOLD) functional magnetic resonance imaging (fMRI), in patients in the chronic phase of traumatic brain injury suffering from fatigue.
SETTING


Neurorehabilitation clinic.
PARTICIPANTS


Patients with traumatic brain injury received either placebo (n = 24) or active treatment (n = 28). Healthy controls (n = 27) went through fMRI examination at one point and were used in sensitivity analysis on normalization of BOLD response.
DESIGN


Randomized, double-blinded, placebo-controlled design.
MAIN MEASURES


Effects on BOLD signal changes from before to after treatment during performance of a fatiguing attention task.
RESULTS


The fMRI results revealed treatment effects within the right occipitotemporal cortex and the right orbitofrontal cortex. In these regions, the BOLD response was normalized relative to healthy controls at the postintervention fMRI session. No effects were seen in regions in which we previously observed activity differences between patients and healthy controls while performing this fMRI task, such as the striatum.
CONCLUSION


(-)-OSU6162 treatment had influences on functional brain activity, although the normalized regional BOLD response was observed in regions that were not a priori hypothesized to be sensitive to this particular treatment, and was not accompanied by any effects on in-scanner test performance or on fatigue.",2019,"No effects were seen in regions in which we previously observed activity differences between patients and healthy controls while performing this fMRI task, such as the striatum.
","['patients in the chronic phase of traumatic brain injury suffering from fatigue', 'Patients with traumatic brain injury received either', 'n = 24) or active treatment (n = 28', 'Patients With Traumatic Brain Injury', 'Neurorehabilitation clinic']","['monoaminergic stabilizer (-)-OSU6162', 'Pharmaco-fMRI', 'Monoaminergic Stabilizer', 'placebo']","['BOLD signal changes', 'functional brain activity', 'blood-oxygen-level-dependent (BOLD) functional magnetic resonance imaging (fMRI', 'BOLD response', 'normalized regional BOLD response', 'performance of a fatiguing attention task']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0204096', 'cui_str': 'Neurologic Rehabilitation'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0966482', 'cui_str': '(-)-OSU6162'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",28.0,0.191813,"No effects were seen in regions in which we previously observed activity differences between patients and healthy controls while performing this fMRI task, such as the striatum.
","[{'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Berginström', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine (Mr Berginström and Dr Nordström), Umeå Center for Functional Brain Imaging (UFBI) (Drs Ekman, Eriksson, and Nyberg), Physiology Section, Department of Integrative Medical Biology (Drs Ekman, Eriksson, and Nyberg), Department of Public Health and Clinical Medicine, Occupational and Environmental Medicine (Dr Nordström), and Department of Radiation Sciences (Dr Nyberg), Umeå University, Umeå, Sweden; Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden (Dr Ekman); and School of Sport Sciences, The Arctic University of Norway, Tromsø, Norway (Dr Nordström).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordström', 'Affiliation': ''}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Ekman', 'Affiliation': ''}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Eriksson', 'Affiliation': ''}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Nyberg', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Nordström', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000440']
3200,23463624,A randomized phase II study comparing capecitabine alone with capecitabine and oral cyclophosphamide in patients with advanced breast cancer-cyclox II.,"BACKGROUND


Capecitabine and cyclophosphamide are active in patients with advanced breast cancer, have non-overlapping toxic effects and synergy pre-clinically. We explored the efficacy and toxic effect of an all-oral combination of capecitabine with cyclophosphamide versus capecitabine alone in a multicentre, randomized, phase II study.
PATIENTS AND METHODS


Patients with locally advanced or metastatic breast cancer were randomized to treatment with capecitabine given continuously (666 mg/m(2) b.i.d. days 1-28) alone (C) or with oral cyclophosphamide (100 mg/m(2) days 1-14 of a 28-day cycle) (CCy) for up to six cycles.
RESULTS


Eighty-two patients were randomized. There was no complete response. The proportions with partial response were 36% on C and 44% on CCy, a difference of 7.9% [95% confidence interval (CI) -13.4 to 29.1]. Significant toxic effect was uncommon: grade ≥3 diarrhoea in 4 (10%) versus 1 (3%) patients; grade ≥3 fatigue in 2 (5%) versus 5 patients (13%) and grade ≥2 hand-foot syndrome in 7 (17%) versus 11 (28%) patients receiving C versus CCy, respectively. Median progression-free survival was 3.1 months on C and 6.9 months on CCy, not significantly different statistically. There was no difference in overall survival.
CONCLUSION


The difference in tumour response suggests a reasonable chance that CCy is superior to C alone.",2013,"Median progression-free survival was 3.1 months on C and 6.9 months on CCy, not significantly different statistically.","['Patients with locally advanced or metastatic breast cancer', 'patients with advanced breast cancer', 'Eighty-two patients were randomized', 'patients with advanced breast cancer-cyclox II']","['capecitabine', 'capecitabine with cyclophosphamide versus capecitabine', 'capecitabine and oral cyclophosphamide', 'Capecitabine and cyclophosphamide', 'oral cyclophosphamide']","['diarrhoea', 'grade ≥3 fatigue', 'overall survival', 'grade ≥2 hand-foot syndrome', 'Median progression-free survival', 'efficacy and toxic effect', 'proportions with partial response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0852711', 'cui_str': 'Hand-foot syndrome in sickle cell anemia (disorder)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",82.0,0.123612,"Median progression-free survival was 3.1 months on C and 6.9 months on CCy, not significantly different statistically.","[{'ForeName': 'V J', 'Initials': 'VJ', 'LastName': 'Harvey', 'Affiliation': 'Regional Cancer and Blood Centre, Auckland City Hospital, Auckland. Electronic address: vernonh@adhb.govt.nz.'}, {'ForeName': 'K J', 'Initials': 'KJ', 'LastName': 'Sharples', 'Affiliation': 'Cancer Trials New Zealand, Division of Oncology, University of Auckland, Auckland; Department of Preventive and Social Medicine, Dunedin School of Medicine, University of Otago, Dunedin.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Isaacs', 'Affiliation': 'Midcentral Regional Cancer Treatment Service, Palmerston North Hospital, Palmerston North.'}, {'ForeName': 'M B', 'Initials': 'MB', 'LastName': 'Jameson', 'Affiliation': 'Waikato Regional Cancer Centre, Waikato Hospital, Hamilton.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Jeffery', 'Affiliation': 'Oncology Service, Christchurch Hospital, Christchurch.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'McLaren', 'Affiliation': 'Southern Blood and Cancer Service, Dunedin Hospital, Dunedin.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pollard', 'Affiliation': 'Cancer Trials New Zealand, Division of Oncology, University of Auckland, Auckland.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Riley', 'Affiliation': 'Cancer Trials New Zealand, Division of Oncology, University of Auckland, Auckland.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Simpson', 'Affiliation': 'Wellington Blood and Cancer Centre, Wellington Hospital, Wellington, New Zealand.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Hinder', 'Affiliation': 'Cancer Trials New Zealand, Division of Oncology, University of Auckland, Auckland.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Scott', 'Affiliation': 'Cancer Trials New Zealand, Division of Oncology, University of Auckland, Auckland.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Dzhelali', 'Affiliation': 'Wellington Blood and Cancer Centre, Wellington Hospital, Wellington, New Zealand.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Findlay', 'Affiliation': 'Cancer Trials New Zealand, Division of Oncology, University of Auckland, Auckland.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdt065']
3201,23028039,Impact of premenopausal status at breast cancer diagnosis in women entered on the placebo-controlled NCIC CTG MA17 trial of extended adjuvant letrozole.,"BACKGROUND


MA17 showed improved outcomes in postmenopausal women given extended letrozole (LET) after completing 5 years of adjuvant tamoxifen.
PATIENTS AND METHODS


Exploratory subgroup analyses of disease-free survival (DFS), distant DFS (DDFS), overall survival (OS), toxic effects and quality of life (QOL) in MA17 were performed based on menopausal status at breast cancer diagnosis.
RESULTS


At diagnosis, 877 women were premenopausal and 4289 were postmenopausal. Extended LET was significantly better than placebo (PLAC) in DFS for premenopausal [hazard ratio (HR) = 0.26, 95% confidence interval (CI) 0.13-0.55; P = 0.0003] and postmenopausal women (HR = 0.67; 95% CI 0.51-0.89; P = 0.006), with greater DFS benefit in those premenopausal (interaction P = 0.03). In adjusted post-unblinding analysis, those who switched from PLAC to LET improved DDFS in premenopausal (HR = 0.15; 95% CI 0.03-0.79; P = 0.02) and postmenopausal women (HR = 0.45; 95% CI 0.22-0.94; P = 0.03).
CONCLUSIONS


Extended LET after 5 years of tamoxifen was effective in pre- and postmenopausal women at diagnosis, and significantly better in those premenopausal. Women premenopausal at diagnosis should be considered for extended adjuvant therapy with LET if menopausal after completing tamoxifen.",2013,Extended LET was significantly better than placebo (PLAC) in DFS for premenopausal [hazard ratio (HR) =,"['postmenopausal women given', '877 women were premenopausal and 4289 were postmenopausal', 'premenopausal status at breast cancer diagnosis in women entered on the placebo-controlled NCIC CTG MA17 trial of extended adjuvant', 'Women premenopausal at diagnosis']","['extended letrozole (LET', 'placebo (PLAC', 'letrozole', 'tamoxifen']","['DDFS', 'disease-free survival (DFS), distant DFS (DDFS), overall survival (OS), toxic effects and quality of life (QOL']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0086562', 'cui_str': 'LET'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0048838', 'cui_str': 'PLAC'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0034380'}]",877.0,0.163022,Extended LET was significantly better than placebo (PLAC) in DFS for premenopausal [hazard ratio (HR) =,"[{'ForeName': 'P E', 'Initials': 'PE', 'LastName': 'Goss', 'Affiliation': 'Cancer Center, Massachusetts General Hospital, Boston. Electronic address: pgoss@partners.org.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Ingle', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, Mayo Clinic, Rochester.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Martino', 'Affiliation': 'Breast Cancer Division, Los Angeles Clinic and Research Institute, Santa Monica.'}, {'ForeName': 'N J', 'Initials': 'NJ', 'LastName': 'Robert', 'Affiliation': 'Virgina Cancer Specialists, Inova Fairfax Hospital, Virgina.'}, {'ForeName': 'H B', 'Initials': 'HB', 'LastName': 'Muss', 'Affiliation': 'Department of Medicine and Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Livingston', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Davidson', 'Affiliation': 'Cancer Institute and UPMC Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Mayo Clinic Cancer Center, Jacksonville, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Chavarri-Guerra', 'Affiliation': 'Cancer Center, Massachusetts General Hospital, Boston.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Cameron', 'Affiliation': 'Edinburgh Breast Unit, Western General Hospital and, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'K I', 'Initials': 'KI', 'LastName': 'Pritchard', 'Affiliation': 'Sunnybrook Odette Regional Cancer Centre, University of Toronto, Toronto.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Whelan', 'Affiliation': 'Department of Oncology, McMaster University, Hamilton.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Shepherd', 'Affiliation': 'National Cancer Institute of Canada, Clinical Trials Group, Kingston, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tu', 'Affiliation': 'National Cancer Institute of Canada, Clinical Trials Group, Kingston, Canada.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mds330']
3202,30916916,Give me a kiss! An integrative rehabilitative training program with motor imagery and mirror therapy for recovery of facial palsy.,"BACKGROUND


Peripheral facial nerve palsy (FNP) can have various causes, such as Bell's palsy or after surgery for acoustic neuroma. Rehabilitation is often required but there is no evidence that any rehabilitation approach is more efficacious than another.
AIM


The purpose of this research was to determine the effects of neurocognitive-rehabilitative approach through mirror-therapy (MT) and motor-imagery (MI), integrated into the traditional rehabilitation with mime-therapy and myofascial-approach.
DESIGN


This study was designed as a double-blind, randomized, controlled trial.
SETTING


This study took place from January 2016 to June 2018 at the Unit of Physical Medicine and Rehabilitation of Umberto I Polyclinic Hospital, Rome, Italy.
POPULATION


Twenty-two patients were randomized into two groups: the mirror therapy group (N.=11, MT and MI) and the traditional rehabilitation group (N.=11, mime-therapy and a myofascial-approach).
METHODS


Outcome assessments were performed before treatment (T0), after one month (T1=10 session, twice/week), after the second and third months (T2=10 twice/week + 5 of MT+MI one/week and T3=10 twice/week + 5 of MT+MI 1/week), and at the 4-week follow-up (T4=2 months follow-up).
RESULTS


The analysis of the functional evaluations show that both groups experienced progressive improvement T0 to T3, with stabilization of the results at the follow-up. There was a significant difference in House-Brackmann-Scale scores between T0 and follow-up in favor of the experimental group. In terms of quality of life (FaCE scale), total scores and social function items improved in both groups from T0 to T3. The experimental group obtained better results with regard to quality of life and emotional depression.
CONCLUSIONS


The integrated use of MT and MI is efficacious in the rehabilitation of FNP, improving facial physical function. Further studies are needed to determine the predictive factors of the recovery of facial mimic.
CLINICAL REHABILITATION IMPACT


The ability of patients with unilateral facial paralysis to recognize and appropriately judge facial expressions and perceive the judgments of others remains underexplored. The likelihood of recovering near-normal facial-function after grade VI facial paralysis is low. Procedures, such as the immediate repair of the facial nerve with an interposed donor graft, might improve facial function in patients with partially injured facial nerves.",2020,"In terms of quality of life (FaCE scale), total scores and social function items improved in both groups from T0 to T3.","['patients with unilateral facial paralysis', 'Twenty-two patients', 'patients with partially injured facial nerves', 'January 2016 to June 2018 at the Unit of Physical Medicine and Rehabilitation, Umberto I Hospital, Rome, Italy']","['mirror-therapy (N=11, MT and MI) and traditional-rehabilitative group (N=11, mime-therapy and a myofascial-approach', 'neurocognitive-rehabilitative approach through mirror-therapy (MT) and motor-imagery (MI', 'integrative rehabilitative training program with motor imagery and mirror therapy']","['recovery of facial palsy', 'facial function', 'quality of life (FaCE scale), total scores and social function items', 'House-Brackmann-Scale scores', 'quality of life and emotional depression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0015469', 'cui_str': 'Facial Palsy'}, {'cui': 'C4284772', 'cui_str': '22 (qualifier value)'}, {'cui': 'C0015462', 'cui_str': 'Nervus Facialis'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0031813', 'cui_str': 'Physiatrics'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0181868', 'cui_str': 'Mirror, device (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0015469', 'cui_str': 'Facial Palsy'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2003847', 'cui_str': 'House (environment)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",22.0,0.0309427,"In terms of quality of life (FaCE scale), total scores and social function items improved in both groups from T0 to T3.","[{'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Paolucci', 'Affiliation': 'Unit of Physical Medicine and Rehabilitation, Umberto I Polyclinic Hospital, Sapienza University, Rome, Italy - teresapaolucci@hotmail.com.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Cardarola', 'Affiliation': 'Department of Anatomy, Histology, Forensic Medicine and Orthopedics, Sapienza University, Rome, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Colonnelli', 'Affiliation': 'Unit of Physical Medicine and Rehabilitation, Umberto I Polyclinic Hospital, Sapienza University, Rome, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Ferracuti', 'Affiliation': 'Unit of Physical Medicine and Rehabilitation, Umberto I Polyclinic Hospital, Sapienza University, Rome, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Gonnella', 'Affiliation': 'Department of Experimental Medicine, Sapienza University, Rome, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Murgia', 'Affiliation': 'Unit of Physical Medicine and Rehabilitation, Umberto I Polyclinic Hospital, Sapienza University, Rome, Italy.'}, {'ForeName': 'Valter', 'Initials': 'V', 'LastName': 'Santilli', 'Affiliation': 'Department of Anatomy, Histology, Forensic Medicine and Orthopedics, Sapienza University, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Paoloni', 'Affiliation': 'Department of Anatomy, Histology, Forensic Medicine and Orthopedics, Sapienza University, Rome, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bernetti', 'Affiliation': 'Department of Anatomy, Histology, Forensic Medicine and Orthopedics, Sapienza University, Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Agostini', 'Affiliation': 'Department of Anatomy, Histology, Forensic Medicine and Orthopedics, Sapienza University, Rome, Italy.'}, {'ForeName': 'Massimiliano', 'Initials': 'M', 'LastName': 'Mangone', 'Affiliation': 'Department of Anatomy, Histology, Forensic Medicine and Orthopedics, Sapienza University, Rome, Italy.'}]",European journal of physical and rehabilitation medicine,['10.23736/S1973-9087.19.05757-5']
3203,31478755,Probiotics for Gastrointestinal Symptoms and Quality of Life in Autism: A Placebo-Controlled Pilot Trial.,"Objective:  A randomized pilot trial of gastrointestinal (GI) symptoms targeting probiotic for quality of life in autism spectrum disorder (ASD).  Methods:  Thirteen children, 3-12 years of age with ASD, anxiety, and GI symptoms, were randomized into a probiotic crossover trial of 8 weeks each on VISBIOME and placebo separated by a 3-week washout. VISBIOME contains eight probiotic species, mostly  Lactobacillus  and  Bifidobacterium . Primary outcome was the Pediatric Quality of Life Inventory (PedsQL) GI module. Secondary outcomes included gut microbiota analysis, the Parent-Rated Anxiety Scale for ASD (PRAS-ASD), and parent-selected target symptoms. A mixed analysis model was applied.  Results:  Thirteen children were randomized, with 10 completing the study (77% retention): 6 in probiotic/placebo sequence, 4 in placebo/probiotic sequence. Adherence to study treatment was 96%. There were no serious adverse events (AEs), and more nonserious AEs occurred with placebo than with probiotic, including those attributable to treatment. Only 6 of the 10 guessed the correct treatment at the end of week 8. Over the 19-week trial, each outcome improved from baseline and PedsQL correlated significantly with abundance of  Lactobacillus  without discernable changes to microbiota composition/diversity. Although probiotic showed more improvement than placebo, PedsQL and PRAS-ASD were not statistically significant, as expected at this sample size. PedsQL effect size was  d  = 0.49 by the general model and  d  = 0.79 by simple comparison of week 8 changes. A parent-selected target symptom showed significant improvement in GI complaints on probiotic compared with placebo ( p  = 0.02,  d  = 0.79). Probiotic effects carried over through the 3-week washout.  Conclusion:  The VISBIOME formulation was safe and suggested a health benefit in children with ASD and GI symptoms who retained  Lactobacillus . The moderate effect size compared with placebo warrants a larger trial using a parallel-group design.",2019,"A parent-selected target symptom showed significant improvement in GI complaints on probiotic compared with placebo ( p  = 0.02,  d  = 0.79).","['children with ASD and GI symptoms who retained  Lactobacillus ', 'Thirteen children', 'autism spectrum disorder (ASD', 'Autism', 'Thirteen children, 3-12 years of age with ASD, anxiety, and GI symptoms']","['probiotic/placebo sequence, 4 in placebo/probiotic sequence', 'Probiotics', 'placebo', 'Placebo', 'gastrointestinal (GI) symptoms targeting probiotic']","['Gastrointestinal Symptoms and Quality of Life', 'Pediatric Quality of Life Inventory (PedsQL', 'Probiotic effects', 'PedsQL effect size', 'serious adverse events (AEs), and more nonserious AEs', 'GI complaints', 'gut microbiota analysis, the Parent-Rated Anxiety Scale for ASD (PRAS-ASD), and parent-selected target symptoms', 'placebo, PedsQL and PRAS-ASD']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0333118', 'cui_str': 'Retained (qualifier value)'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}]","[{'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0034380'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",13.0,0.449744,"A parent-selected target symptom showed significant improvement in GI complaints on probiotic compared with placebo ( p  = 0.02,  d  = 0.79).","[{'ForeName': 'L Eugene', 'Initials': 'LE', 'LastName': 'Arnold', 'Affiliation': 'Department of Psychiatry, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Ruth Ann', 'Initials': 'RA', 'LastName': 'Luna', 'Affiliation': 'Department of Pathology & Immunology, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Department of Pediatrics, Nationwide Childrens Hospital, Columbus, Ohio.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Parker', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Qinglong', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Pathology & Immunology, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Hollway', 'Affiliation': 'Department of Psychiatry, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Adelina', 'Initials': 'A', 'LastName': 'Jeffs', 'Affiliation': 'Department of Psychiatry, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Coury', 'Affiliation': 'Department of Pediatrics, Nationwide Childrens Hospital, Columbus, Ohio.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Hayes', 'Affiliation': 'Department of Pediatrics, Nationwide Childrens Hospital, Columbus, Ohio.'}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Savidge', 'Affiliation': 'Department of Pathology & Immunology, Baylor College of Medicine, Houston, Texas.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0156']
3204,30657024,Newest evidence for tetrahydrocannabinol:cannabidiol oromucosal spray from randomized clinical trials.,"Subsequent to EMA approval of tetrahydrocannabinol (THC): cannabidiol (CBD) oromucosal spray based on results of various studies, including an enriched-design clinical trial, two newer postapproval randomized trials have confirmed its efficacy and safety for treating resistant multiple sclerosis spasticity, while simultaneously addressing specific authorities' concerns. A double-blind, placebo-controlled, Phase IV trial, conducted as part of the EMA's risk management plan, found no effect of THC:CBD spray on cognition and mood after 50 weeks of treatment. In the Sativex ®  as add-on therapy versus further optimized first-line ANTispastics (SAVANT)  study, add-on THC:CBD spray was significantly more effective than readjusting standard antispasticity therapy and provided new evidence of efficacy as requested by German authorities. SAVANT results support practical recommendations for treating resistant multiple sclerosis spasticity in daily practice.",2019,"Subsequent to EMA approval of tetrahydrocannabinol (THC): cannabidiol (CBD) oromucosal spray based on results of various studies, including an enriched-design clinical trial, two newer postapproval randomized trials have confirmed its efficacy and safety for treating resistant multiple sclerosis spasticity, while simultaneously addressing specific authorities' concerns.",[],"['tetrahydrocannabinol (THC): cannabidiol (CBD) oromucosal spray', 'placebo', 'THC:CBD spray']",[],[],"[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C1273657', 'cui_str': 'Oromucosal spray'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521772', 'cui_str': 'Spray'}]",[],2.0,0.242961,"Subsequent to EMA approval of tetrahydrocannabinol (THC): cannabidiol (CBD) oromucosal spray based on results of various studies, including an enriched-design clinical trial, two newer postapproval randomized trials have confirmed its efficacy and safety for treating resistant multiple sclerosis spasticity, while simultaneously addressing specific authorities' concerns.","[{'ForeName': 'Jolana', 'Initials': 'J', 'LastName': 'Marková', 'Affiliation': 'Neurology Department, Charles University, 3rd Faculty of Medicine and Thomayer Hospital, Czechia.'}]",Neurodegenerative disease management,['10.2217/nmt-2018-0050']
3205,31343273,Mineral-Vitamin Treatment Associated with Remission in Attention-Deficit/Hyperactivity Disorder Symptoms and Related Problems: 1-Year Naturalistic Outcomes of a 10-Week Randomized Placebo-Controlled Trial.,"Objective:  This article presents 1-year follow-up of a randomized placebo-controlled trial with open-label extension evaluating the efficacy of a broad-spectrum micronutrient (vitamins and minerals) intervention. The object was to determine if dominant treatment at follow-up was associated with differential psychological outcomes.  Methods:  Ninety percent of the original sample of 93 children with attention-deficit/hyperactivity disorder (ADHD) were followed 52 weeks postbaseline. Assessments included measures of ADHD, mood, anxiety, and general function based on parent/clinician report. Outcome was considered based on dominant therapy at 52 weeks (trial micronutrients [ n  = 19], medications [ n  = 21], and no treatment [ n  = 35]). Nine children were not categorized due to inconsistent therapies.  Results:  Based on dominant treatment, more of those who stayed on trial micronutrients (84%) were identified as ""Much"" or ""Very Much"" improved overall relative to baseline functioning, compared to 50% of those who switched to psychiatric medications and only 21% of those who discontinued treatment [χ 2 (2) = 19.476,  p  < 0.001]. Fifteen (79%) of those still taking micronutrients, 8 (42%) of those using medications, and 7 (23%) of those who discontinued treatment were considered remitters based on parent-reported ADHD [χ 2 (2) = 15.3,  p  < 0.001]. Those who stayed on micronutrients were more likely to have failed medication treatment in the past. The micronutrient group also displayed better outcomes on measures of parent-rated hyperactivity and anxiety, and clinician-rated general function and mood, with moderate to large between-group effect sizes (micronutrients vs. medication: ES = 0.73-1.01; micronutrients vs. no treatment: ES = 0.54-1.01). Most common reasons for stopping trial micronutrients were cost and number of pills to swallow. No continued side effects were associated with micronutrients.  Conclusions:  Children who benefitted from micronutrients in the short term maintained changes at follow-up, without side effects. While both those who continued micronutrients and those who switched to medication showed improved ADHD symptoms, psychiatric medication use was associated with deterioration in mood and anxiety. Inherent selection bias limits generalizability.",2019,"The micronutrient group also displayed better outcomes on measures of parent-rated hyperactivity and anxiety, and clinician-rated general function and mood, with moderate to large between-group effect sizes (micronutrients vs. medication: ES = 0.73-1.01; micronutrients vs. no treatment: ES = 0.54-1.01).",['Methods:  Ninety percent of the original sample of 93 children with attention-deficit/hyperactivity disorder (ADHD'],"['broad-spectrum micronutrient (vitamins and minerals) intervention', 'Mineral-Vitamin', 'Placebo', 'placebo']","['ADHD symptoms, psychiatric medication', 'measures of parent-rated hyperactivity and anxiety, and clinician-rated general function and mood', 'measures of ADHD, mood, anxiety, and general function based on parent/clinician report', 'deterioration in mood and anxiety', 'cost and number of pills to swallow', 'side effects']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0026162', 'cui_str': 'Minerals'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0424295', 'cui_str': 'Increased purposeful goal-directed activity'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0326374', 'cui_str': 'Swallows'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",93.0,0.153641,"The micronutrient group also displayed better outcomes on measures of parent-rated hyperactivity and anxiety, and clinician-rated general function and mood, with moderate to large between-group effect sizes (micronutrients vs. medication: ES = 0.73-1.01; micronutrients vs. no treatment: ES = 0.54-1.01).","[{'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Darling', 'Affiliation': 'Department of Psychology, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Matthew J F', 'Initials': 'MJF', 'LastName': 'Eggleston', 'Affiliation': 'Canterbury District Health Board, Christchurch, New Zealand.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Retallick-Brown', 'Affiliation': 'Department of Psychology, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Julia J', 'Initials': 'JJ', 'LastName': 'Rucklidge', 'Affiliation': 'Department of Psychology, University of Canterbury, Christchurch, New Zealand.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2019.0036']
3206,32088296,"Effects of Colesevelam on Bowel Symptoms, Biomarkers, and Colonic Mucosal Gene Expression in Patients With Bile Acid Diarrhea in a Randomized Trial.","BACKGROUND & AIMS


Approximately one-third of patients with IBS-diarrhea (IBS-D) have increased bile acid (BA) synthesis or excretion. An open-label study showed benefits of colesevelam on bowel functions, consistent with luminal BA sequestration by colesevelam. We compared the effects of colesevelam vs placebo on symptoms and gene expression patterns in the sigmoid colon mucosa in patients with BA diarrhea associated with IBS-D.
METHODS


We performed a double-blind, parallel-group study of 30 adults with IBS-D and evidence of increased BA synthesis or fecal excretion, from December 2017 through December 2018 at a single center. Patients were randomly assigned (1:1) to groups given colesevelam (3 tablets, 625 mg each) or matching placebo, orally twice daily for 4 weeks. Stool diaries documented bowel functions for 8 days before and 28 days during colesevelam or placebo. Stool and fasting serum samples were collected for analyses of fecal BAs and serum levels of C4 and FGF19. We measured colonic transit by scintigraphy, mucosal permeability by in vivo excretion of saccharide probes, and mRNA levels in rectosigmoid biopsies. All measurements were made at baseline and on the last days of treatment. The primary endpoints were change in total fecal BA concentration and stool consistency.
RESULTS


Compared with placebo, colesevelam was associated with significant changes in sequestered fecal total BA excretion (P < .001) and serum levels of C4 and FGF19 (both P < .001), and with a mean increase in fecal level of deoxycholic acid (10%; P = .07) compared to placebo. Colesevelam decreased colon mucosal expression of NR1H4 and P2RY4 and increased expression of GPBAR1, compared with baseline. Stool frequency and consistency, colonic transit, and permeability did not differ significantly between groups. Colesevelam was well tolerated.
CONCLUSIONS


In a randomized trial, we found that colesevelam increases delivery of total and secondary BAs to stool, hepatic BA synthesis, and colonic mucosal expression of genes that regulate BA, farnesoid X, and GPBAR1 receptors. Larger studies are needed to determine the effects on clinical responses. ClinicalTrials.gov no: NCT03270085.",2020,"Colesevelam decreased colon mucosal expression of NR1H4 and P2RY4 and increased expression of GPBAR1, compared with baseline.","['Patients with Bile Acid Diarrhea', '30 adults with IBS-D and evidence of increased BA synthesis or fecal excretion, from December 2017 through December 2018 at a single center', 'patients with BA diarrhea associated with IBS-D']","['Colesevelam', 'colesevelam vs placebo', 'placebo', 'colesevelam (3 tablets, 625 mg each) or matching placebo']","['delivery of total and secondary BAs to stool, hepatic BA synthesis, and colonic mucosal expression of genes that regulate BA, farnesoid X, and GPBAR1 receptors', 'colonic transit by scintigraphy, mucosal permeability by in vivo excretion of saccharide probes, and mRNA levels', 'Stool frequency and consistency, colonic transit, and permeability', 'tolerated', 'bile acid (BA) synthesis or excretion', 'total fecal BA concentration and stool consistency', 'sequestered fecal total BA excretion (P<.001) and serum levels of C4 and FGF19', 'Stool and fasting serum samples', 'Bowel Symptoms, Biomarkers, and Colonic Mucosal Gene Expression', 'colon mucosal expression of NR1H4 and P2RY4 and increased expression of GPBAR1', 'fecal level of deoxycholic acid', 'fecal BAs and serum levels of C4 and FGF19']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4524087', 'cui_str': 'Bile acid diarrhea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}]","[{'cui': 'C0541155', 'cui_str': 'colesevelam'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0034606', 'cui_str': 'Gamma Camera Imaging'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0007004', 'cui_str': 'Carbohydrates'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0011479', 'cui_str': 'Deoxycholic Acid'}]",30.0,0.381983,"Colesevelam decreased colon mucosal expression of NR1H4 and P2RY4 and increased expression of GPBAR1, compared with baseline.","[{'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vijayvargiya', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota. Electronic address: camilleri.michael@mayo.edu.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Carlson', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Sara Linker', 'Initials': 'SL', 'LastName': 'Nord', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ryks', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Rhoten', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Burton', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Busciglio', 'Affiliation': 'Division of Gastroenterology and Hepatology, Clinical Enteric Neuroscience Translational and Epidemiological Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Lueke', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'W Scott', 'Initials': 'WS', 'LastName': 'Harmsen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Leslie J', 'Initials': 'LJ', 'LastName': 'Donato', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.02.027']
3207,31642985,Effect of food-related behavioral activation therapy on food intake and the environmental impact of the diet: results from the MooDFOOD prevention trial.,"PURPOSE


Food-based dietary guidelines are proposed to not only improve diet quality, but to also reduce the environmental impact of diets. The aim of our study was to investigate whether food-related behavioral activation therapy (F-BA) applying Mediterranean-style dietary guidelines altered food intake and the environmental impact of the diet in overweight adults with subsyndromal symptoms of depression.
METHODS


In total 744 adults who either received the F-BA intervention (F-BA group) or no intervention (control group) for 12 months were included in this analysis. Food intake data were collected through a food frequency questionnaire at baseline and after 6 and 12 months. Greenhouse gas emissions (GHGE), land use (LU), and fossil energy use (FEU) estimates from life-cycle assessments and a weighted score of the three (pReCiPe score) were used to estimate the environmental impact of each individual diet at each timepoint.
RESULTS


The F-BA group reported increased intakes of vegetables (19.7 g/day; 95% CI 7.8-31.6), fruit (23.0 g/day; 9.4-36.6), fish (7.6 g/day; 4.6-10.6), pulses/legumes (4.0 g/day; 1.6-6.5) and whole grains (12.7 g/day; 8.0-17.5), and decreased intake of sweets/extras (- 6.8 g/day; - 10.9 to - 2.8) relative to control group. This effect on food intake resulted in no change in GHGE, LU, and pReCiPe score, but a relative increase in FEU by 1.6 MJ/day (0.8, 2.4).
CONCLUSIONS


A shift towards a healthier Mediterranean-style diet does not necessarily result in a diet with reduced environmental impact in a real-life setting.
TRIAL REGISTRATION


ClinicalTrials.gov. Number of identification: NCT02529423. August 2015.",2020,"The F-BA group reported increased intakes of vegetables (19.7 g/day; 95% CI 7.8-31.6), fruit (23.0 g/day; 9.4-36.6), fish (7.6 g/day; 4.6-10.6), pulses/legumes (4.0 g/day; 1.6-6.5) and whole grains (12.7 g/day; 8.0-17.5), and decreased intake of sweets/extras (- 6.8 g/day; - 10.9 to - 2.8) relative to control group.","['In total 744 adults who either received the', 'overweight adults with subsyndromal symptoms of depression']","['F-BA intervention (F-BA group) or no intervention (control group', 'food-related behavioral activation therapy (F-BA) applying Mediterranean-style dietary guidelines', 'food-related behavioral activation therapy']","['Greenhouse gas emissions (GHGE), land use (LU), and fossil energy use (FEU) estimates from life-cycle assessments and a weighted score of the three (pReCiPe score', 'intake of sweets/extras', 'FEU', 'intakes of vegetables', 'GHGE, LU, and pReCiPe score', 'diet quality']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2733064', 'cui_str': 'Behavioral activation therapy (regime/therapy)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C3658297', 'cui_str': 'Nutrition Guidelines'}]","[{'cui': 'C4505224', 'cui_str': 'Greenhouse Gases'}, {'cui': 'C0233929', 'cui_str': 'Emission (finding)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0016614', 'cui_str': 'Fossils'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0023675', 'cui_str': 'Life Cycle'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",744.0,0.159008,"The F-BA group reported increased intakes of vegetables (19.7 g/day; 95% CI 7.8-31.6), fruit (23.0 g/day; 9.4-36.6), fish (7.6 g/day; 4.6-10.6), pulses/legumes (4.0 g/day; 1.6-6.5) and whole grains (12.7 g/day; 8.0-17.5), and decreased intake of sweets/extras (- 6.8 g/day; - 10.9 to - 2.8) relative to control group.","[{'ForeName': 'Alessandra C', 'Initials': 'AC', 'LastName': 'Grasso', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health Research Institute, Vrije Universiteit (VU) Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands. alessandra.grasso@vu.nl.'}, {'ForeName': 'Margreet R', 'Initials': 'MR', 'LastName': 'Olthof', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health Research Institute, Vrije Universiteit (VU) Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Corné', 'Initials': 'C', 'LastName': 'van Dooren', 'Affiliation': 'Netherlands Nutrition Centre (Voedingscentrum), Bezuidenhoutseweg 105, 2594 AC, The Hague, The Netherlands.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Roca', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut (IUNICS/IDISBA), Rediapp, University of Balearic Islands, Carretera De Valldemossa km 7.5, 07122, Palma de Mallorca, Spain.""}, {'ForeName': 'Margalida', 'Initials': 'M', 'LastName': 'Gili', 'Affiliation': ""Institut Universitari d'Investigació en Ciències de la Salut (IUNICS/IDISBA), Rediapp, University of Balearic Islands, Carretera De Valldemossa km 7.5, 07122, Palma de Mallorca, Spain.""}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Visser', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health Research Institute, Vrije Universiteit (VU) Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Cabout', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health Research Institute, Vrije Universiteit (VU) Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Bot', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, and GGZ inGeest Specialized Mental Health Care, Amsterdam UMC, VU Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Brenda W J H', 'Initials': 'BWJH', 'LastName': 'Penninx', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, and GGZ inGeest Specialized Mental Health Care, Amsterdam UMC, VU Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'van Grootheest', 'Affiliation': 'Department of Psychiatry, Amsterdam Public Health Research Institute, and GGZ inGeest Specialized Mental Health Care, Amsterdam UMC, VU Amsterdam, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kohls', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, University Leipzig, Semmelweisstr. 10, Haus 13, 04103, Leipzig, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Hegerl', 'Affiliation': 'Department of Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty, Goethe-University Frankfurt, Heinrich-Hoffmann-Str. 10, 60528, Frankfurt a.M., Germany.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Owens', 'Affiliation': 'Department of Psychology, University of Exeter, Perry Road, Exeter, EX4 4QG, UK.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Watkins', 'Affiliation': 'Department of Psychology, University of Exeter, Perry Road, Exeter, EX4 4QG, UK.'}, {'ForeName': 'Ingeborg A', 'Initials': 'IA', 'LastName': 'Brouwer', 'Affiliation': 'Department of Health Sciences, Faculty of Science, and Amsterdam Public Health Research Institute, Vrije Universiteit (VU) Amsterdam, De Boelelaan 1085, 1081 HV, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of nutrition,['10.1007/s00394-019-02106-1']
3208,30686751,Cholecalciferol Supplementation Did Not Change Interleukin-7 and B cell-Activating Factor Levels and CD95 Expression in B lymphocytes in Patients on Dialysis: A Randomized Pilot-Controlled Trial.,"BACKGROUND


End-stage renal disease results in B cell lymphopenia and low levels of vitamin D. Since the link between vitamin D deficiency and B lymphocytes dysfunction are not clear in patients with end-stage renal disease, we suggest that vitamin D adequacy and factors related to the homeostasis of these cells should be investigated. B lymphocytes homeostasis is a process mainly regulated signals of grown and death as interleukin (IL)-7, B cell-activating factor (BAFF)/BAFF-receptor and CD95 expression.
OBJECTIVE


As vitamin D serum levels were reduced in patients with end stage renal disease and it is associated with human B homeostasis, we evaluated the effect of cholecalciferol supplementation on dialysis.
DESIGN


Randomized, double blind clinical trial in dialysis patients with 25OH Vitamin D deficiency for a period of 12 weeks.
MAIN OUTCOME MEASURE


In a pilot study, we investigated the effect of cholecalciferol supplementation (100,000 UI once per week or placebo. In vitro, peripheral blood mononuclear cells isolated by Ficoll-Hypaque centrifugation from 12 healthy volunteers were incubated with healthy or uremic serum in the presence or absence of 25 (OH)DC with 5% CO.
RESULTS


There was an increase in the serum 25(OH)D level in the cholecalciferol group. No differences were found in BAFF and IL7 levels and CD95 and BAFF-R expression in B lymphocytes from patients on dialysis after cholecalciferol supplementation. Uremic serum induced an increase in the IL-7, BAFF, BAFF-R and CD95 expression compared with the control. However, we observed no effect of incubation of 25(OH)D3 and 1,25(OH)2D3 on the expression of IL-7, BAFF, BAFF-R and CD95 when incubated in the presence of normal or uremic serum.
CONCLUSION


Our results suggest that vitamin D is not involved in mechanisms of regulation of differentiation and survival in B lymphocytes. In conclusion, further studies are needed to explore the effects of vitamin D on B lymphocytes to better evaluate the possible impact of vitamin D on humoral response in the CKD population.",2019,No differences were found in BAFF and IL7 levels and CD95 and BAFF-R expression in B lymphocytes from patients on dialysis after cholecalciferol supplementation.,"['Patients on Dialysis', 'patients with end stage renal disease and it is associated with human B homeostasis', 'dialysis patients with 25OH Vitamin D deficiency for a period of 12 weeks', 'patients with end-stage renal disease', '12 healthy volunteers were incubated with healthy or uremic serum in the presence or absence of 25']","['vitamin D', 'cholecalciferol supplementation', 'placebo', 'Cholecalciferol Supplementation']","['serum 25(OH)D level', 'vitamin D serum levels', 'IL-7, BAFF, BAFF-R and CD95 expression', 'Uremic serum', 'Change Interleukin-7 and B cell-Activating Factor Levels and CD95 Expression', 'expression of IL-7, BAFF, BAFF-R and CD95', 'BAFF and IL7 levels and CD95 and BAFF-R expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C3854307', 'cui_str': 'Presence'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0021761', 'cui_str': 'Interleukin-7'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0767393', 'cui_str': 'TNFSF13B Protein'}]",12.0,0.184019,No differences were found in BAFF and IL7 levels and CD95 and BAFF-R expression in B lymphocytes from patients on dialysis after cholecalciferol supplementation.,"[{'ForeName': 'José Tarcisio Giffoni', 'Initials': 'JTG', 'LastName': 'de Carvalho', 'Affiliation': 'Division of Nephrology- Universidade Federal São Paulo, UNIFESP, São Paulo, São Paulo, Brazil. Electronic address: tarcisiogiffoni@outlook.com.br.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Division of Nephrology- Universidade Federal São Paulo, UNIFESP, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Cuppari', 'Affiliation': 'Division of Nephrology- Universidade Federal São Paulo, UNIFESP, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Caren Cristina', 'Initials': 'CC', 'LastName': 'Grabulosa', 'Affiliation': 'Division of Nephrology- Universidade Federal São Paulo, UNIFESP, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Cendoroglo', 'Affiliation': 'Division of Nephrology- Universidade Federal São Paulo, UNIFESP, São Paulo, São Paulo, Brazil; Hospital Israelita Albert Einstein, São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Maria Aparecida', 'Initials': 'MA', 'LastName': 'Dalboni', 'Affiliation': 'Division of Nephrology- Universidade Federal São Paulo, UNIFESP, São Paulo, São Paulo, Brazil; Post-graduate Program in Medicine, Universidade Nove de Julho/UNINOVE, São Paulo, São Paulo, Brazil.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2018.11.006']
3209,30681964,Developing a Mobile App (LYNX) to Support Linkage to HIV/Sexually Transmitted Infection Testing and Pre-Exposure Prophylaxis for Young Men Who Have Sex With Men: Protocol for a Randomized Controlled Trial.,"BACKGROUND


Young men who have sex with men (YMSM) in the United States have among the highest incidence of HIV and sexually transmitted infection (STI) and the lowest uptake of HIV and STI testing and pre-exposure prophylaxis (PrEP). Nearly universal mobile phone ownership among youth provides an opportunity to leverage mobile health apps to increase HIV/STI testing and PrEP uptake among YMSM.
OBJECTIVE


The goals of this project are to develop and refine LYNX, a novel mobile app to support linkage to HIV/STIs testing and PrEP services among YMSM in the United States, and to evaluate the acceptability and feasibility of LYNX in a pilot randomized controlled trial (RCT).
METHODS


This research protocol will be conducted in 3 phases: an iterative development phase with a series of 3 focus groups among 20 YMSM to refine the LYNX app; an open technical pilot among 15 YMSM to optimize usability of the app; and then a 6-month pilot RCT among 60 HIV-uninfected YMSM at risk for HIV acquisition. Developed using the Information, Motivation, and Behavioral skills theoretical model, the LYNX app includes an electronic diary to track sexual behaviors (information), a personalized risk score to promote accurate risk perception (information/motivation), testing reminders (motivation/behavioral skills), and access to home-based HIV/STI testing options and geospatial-based HIV/STI testing care sites (behavioral skills). Feasibility and acceptability will be assessed through app analytics of usage patterns and acceptability scales administered via computer-assisted self-interview at 3 and 6 months. We will also evaluate preliminary efficacy by comparing the proportion of YMSM who test at least once during the 6-month pilot and the proportion who successfully link to a PrEP provider in the intervention versus control groups.
RESULTS


Formative work is currently underway. The LYNX pilot RCT will begin enrollment in October 2018, with study results available in 2019.
CONCLUSIONS


The LYNX app is one of the first mobile apps designed to increase HIV/STI testing and PrEP uptake among YMSM. As low-perceived risk is a barrier to HIV/STI testing and PrEP use among youth, the personalized risk assessment and interactive sexual diary in LYNX could assist YMSM in better understanding their HIV risk and providing motivation to test for HIV/STIs and initiate PrEP. Coupled with community-based recruitment, this novel mobile app has great potential to reach and engage YMSM not currently involved in care and increase rates of HIV/STI testing and PrEP uptake in this vulnerable population.
TRIAL REGISTRATION


ClinicalTrials.gov NCT03177512; https://clinicaltrials.gov/ct2/show/NCT03177512 (Archived by WebCite at http://www.webcitation.org/73c917wAw).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)


PRR1-10.2196/10659.",2019,The LYNX app is one of the first mobile apps designed to increase HIV/STI testing and PrEP uptake among YMSM.,"['Young Men', 'Young men who have sex with men (YMSM']","['Mobile App (LYNX', 'testing reminders (motivation/behavioral skills), and access to home-based HIV/STI testing options and geospatial-based HIV/STI testing care sites (behavioral skills']",['Feasibility and acceptability'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0325104', 'cui_str': 'Lynx'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.109159,The LYNX app is one of the first mobile apps designed to increase HIV/STI testing and PrEP uptake among YMSM.,"[{'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'Bridge HIV, San Francisco Department of Public Health, San Francisco, CA, United States.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Coleman', 'Affiliation': 'Bridge HIV, San Francisco Department of Public Health, San Francisco, CA, United States.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Bojan', 'Affiliation': 'John H Stroger Jr Hospital, Chicago, IL, United States.'}, {'ForeName': 'Pedro Alonso', 'Initials': 'PA', 'LastName': 'Serrano', 'Affiliation': 'John H Stroger Jr Hospital, Chicago, IL, United States.'}, {'ForeName': 'Temitope', 'Initials': 'T', 'LastName': 'Oyedele', 'Affiliation': 'John H Stroger Jr Hospital, Chicago, IL, United States.'}, {'ForeName': 'Amayvis', 'Initials': 'A', 'LastName': 'Garcia', 'Affiliation': 'Department of Pediatrics, University of South Florida, Tampa, Tampa, FL, United States.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Enriquez-Bruce', 'Affiliation': 'Department of Pediatrics, University of South Florida, Tampa, Tampa, FL, United States.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Emmanuel', 'Affiliation': 'Department of Pediatrics, University of South Florida, Tampa, Tampa, FL, United States.'}, {'ForeName': 'Jeb', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Sullivan', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hightow-Weidman', 'Affiliation': 'Institute of Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Buchbinder', 'Affiliation': 'Bridge HIV, San Francisco Department of Public Health, San Francisco, CA, United States.'}, {'ForeName': 'Hyman', 'Initials': 'H', 'LastName': 'Scott', 'Affiliation': 'Bridge HIV, San Francisco Department of Public Health, San Francisco, CA, United States.'}]",JMIR research protocols,['10.2196/10659']
3210,31699651,Gastric sleeve resection as day-case surgery: what affects the discharge time?,"BACKGROUND


Sleeve gastrectomy, with its short operating time, is possible to perform as same-day surgery, with the most common reason for requiring overnight hospital stay being postoperative nausea and vomiting.
OBJECTIVE


To demonstrate the feasibility and safety of sleeve gastrectomy as same-day surgery with regard to complication rate. Additionally, the study aimed to evaluate factors determining the duration of hospital stay, such as type of anesthesia, time of procedure, degree of postoperative nausea and pain, American Society of Anesthesiologists score, or previous abdominal surgery.
SETTING


Nonacademic primary referral center.
METHODS


A substudy of a single-center, double-blind, randomized controlled trial. Patients included in this study underwent sleeve gastrectomy and were randomized into 1 of the following 2 types of anesthesia: total intravenous anesthesia with propofol or desflurane. Primary endpoint was the number of patients discharged the same day as surgery. Secondary endpoints were unplanned telephone calls, readmission rate, and complication rate. Time of procedure was registered by the staff at the operation theatre. Visual analog scales score estimating patients' intensity of pain and nausea were completed at the postoperative unit, surgical ward, and 24 to 48 hours postoperatively.
RESULTS


Ninety-three patients were included in the study. Fifty-nine (63%) were discharged the same day as surgery (32 desflurane and 27 total intravenous anesthesia), 30 patients (32%) were discharged 1 day after surgery, and 4 patients (4%) were discharged after >2 days (15 desflurane and 19 total intravenous anesthesia). The most common reasons for prolonged stay were pain, nausea, and fatigue. Statistical analyses showed no association between day of discharge and the type of anesthesia, time of the procedure, degree of postoperative nausea and vomiting, pain intensity, American Society of Anesthesiologists score, or previous abdominal surgery.
CONCLUSION


Same-day surgery is feasible and safe in terms of low complication rate. The type of anesthesia, time of procedure, degree of postoperative nausea and vomiting and pain, American Society of Anesthesiologists score and previous abdominal surgery does not appear to affect length of hospital stay.",2019,"Statistical analyses showed no association between day of discharge and the type of anesthesia, time of the procedure, degree of postoperative nausea and vomiting, pain intensity, American Society of Anesthesiologists score, or previous abdominal surgery.
","['Ninety-three patients were included in the study', 'Nonacademic primary referral center']","['anesthesia: total intravenous anesthesia with propofol or desflurane', 'sleeve gastrectomy', 'Gastric sleeve resection as day-case surgery']","['unplanned telephone calls, readmission rate, and complication rate', 'postoperative nausea and vomiting, pain intensity, American Society of Anesthesiologists score, or previous abdominal surgery', 'pain, nausea, and fatigue', ""Visual analog scales score estimating patients' intensity of pain and nausea"", 'duration of hospital stay, such as type of anesthesia, time of procedure, degree of postoperative nausea and pain, American Society of Anesthesiologists score, or previous abdominal surgery', 'number of patients discharged the same day as surgery']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0396585', 'cui_str': 'Pneumonectomy with tracheobronchoplasty (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0520904', 'cui_str': 'Postoperative Nausea'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",93.0,0.162305,"Statistical analyses showed no association between day of discharge and the type of anesthesia, time of the procedure, degree of postoperative nausea and vomiting, pain intensity, American Society of Anesthesiologists score, or previous abdominal surgery.
","[{'ForeName': 'Hira', 'Initials': 'H', 'LastName': 'Aftab', 'Affiliation': 'Department of Morbid Obesity and Bariatric Surgery, Østfold Hospital Trust, Grålum, Norway; Department of Gastrointestinal Surgery, Østfold Hospital Trust, Grålum, Norway; Institute of clinical medicine, University of Oslo, Oslo, Norway. Electronic address: hira.aftab@so-hf.no.'}, {'ForeName': 'Morten Wang', 'Initials': 'MW', 'LastName': 'Fagerland', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ghous', 'Initials': 'G', 'LastName': 'Gondal', 'Affiliation': 'Department of Morbid Obesity and Bariatric Surgery, Østfold Hospital Trust, Grålum, Norway; Department of Gastrointestinal Surgery, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Ghanima', 'Affiliation': 'Institute of clinical medicine, University of Oslo, Oslo, Norway; Department of Reasearch, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Magnus Kringstad', 'Initials': 'MK', 'LastName': 'Olsen', 'Affiliation': 'Department of Reasearch, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Nordby', 'Affiliation': 'Department of Morbid Obesity and Bariatric Surgery, Østfold Hospital Trust, Grålum, Norway; Department of Gastrointestinal Surgery, Østfold Hospital Trust, Grålum, Norway.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2019.09.070']
3211,30829117,Robot-assisted gait training is not superior to intensive overground walking in multiple sclerosis with severe disability (the RAGTIME study): A randomized controlled trial.,"BACKGROUND


Rehabilitation may attenuate the impact on mobility of patients with progressive multiple sclerosis (MS) and severe gait disabilities.
OBJECTIVE


In this randomized controlled trial, we compared robot-assisted gait training (RAGT) with conventional therapy (CT) in terms of gait speed, mobility, balance, fatigue and quality of life (QoL).
METHODS


Seventy-two patients with MS (expanded disability status scale score 6.0-7.0) were randomized to receive 12 training sessions over a 4-week period of RAGT ( n  = 36) or overground walking therapy ( n  = 36). The primary outcome was gait speed, assessed by the timed 25-foot walk test. Secondary outcome measures were walking endurance, balance, depression, fatigue and QoL. Tests were performed at baseline, intermediate, at the end of treatment and at a 3-month follow-up.
RESULTS


Sixty-six patients completed the treatments. At the end of treatment with respect to baseline, both groups significantly improved gait speed ( p  < 0.001) and most secondary outcomes without between-group differences. Outcome values returned to baseline at follow-up.
CONCLUSIONS


RAGT was not superior to CT in improving gait speed in patients with progressive MS and severe gait disabilities where a positive, even transitory, effect of rehabilitation was observed.",2020,"At the end of treatment with respect to baseline, both groups significantly improved gait speed ( p < 0.001) and most secondary outcomes without between-group differences.","['patients with progressive multiple sclerosis (MS) and severe gait disabilities', '\n\n\nSeventy-two patients with MS (expanded disability status scale score 6.0-7.0', 'multiple sclerosis with severe disability']","['12 training sessions over a 4-week period of RAGT ( n\u2009=\u200936) or overground walking therapy', 'robot-assisted gait training (RAGT) with conventional therapy (CT', 'RAGT', 'CT', 'Robot-assisted gait training']","['gait speed, mobility, balance, fatigue and quality of life (QoL', 'walking endurance, balance, depression, fatigue and QoL. Tests', 'gait speed, assessed by the timed 25-foot walk test', 'gait speed', 'severe gait disabilities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}]",72.0,0.102542,"At the end of treatment with respect to baseline, both groups significantly improved gait speed ( p < 0.001) and most secondary outcomes without between-group differences.","[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Straudi', 'Affiliation': 'Department of Neuroscience and Rehabilitation, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Manfredini', 'Affiliation': 'Department of Neuroscience and Rehabilitation, University Hospital of Ferrara, Ferrara, Italy/ Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lamberti', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Carlotta', 'Initials': 'C', 'LastName': 'Martinuzzi', 'Affiliation': 'Department of Neuroscience and Rehabilitation, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Maietti', 'Affiliation': 'Center for Clinical Epidemiology, Department of Medical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Nino', 'Initials': 'N', 'LastName': 'Basaglia', 'Affiliation': 'Department of Neuroscience and Rehabilitation, University Hospital of Ferrara, Ferrara, Italy/ Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458519833901']
3212,31232088,The effect of nature sounds and earplugs on anxiety in patients following percutaneous coronary intervention: A randomized controlled trial.,"BACKGROUND


Percutaneous coronary interventions cause anxiety in patients, although these procedures are lifesaving.
AIM


The aim of this study was to determine the effect of nature sounds and earplug interventions on the anxiety of patients after percutaneous coronary interventions.
METHODS


A randomized controlled trial design was used in this study. A total of 114 patients who were scheduled to undergo percutaneous coronary intervention were allocated to three groups in a randomized manner: two intervention groups (nature sound group, earplug group) and one control group. The Visual Analog Scale, State Anxiety Inventory and physiological parameters were used to measure anxiety. Data were collected from the patients at three time points: immediately before, immediately after and 30 minutes after the interventions.
RESULTS


The respiratory rates and the Visual Analog Scale and State Anxiety Inventory scores of patients in the nature sound and earplug groups immediately after and 30 minutes after the interventions were significantly lower than those of the control group ( p  < 0.05). No differences were found when comparing respiratory rates, Visual Analog Scale scores and State Anxiety Inventory scores between patients in the nature sound group and patients in the earplug group ( p  > 0.05). No changes were observed in the pulse and systolic/diastolic blood pressure values of patients in the control and intervention groups ( p  > 0.05).
CONCLUSIONS


It was determined that nature sounds and earplug interventions are effective in reducing the anxiety of patients following percutaneous coronary intervention.",2019,It was determined that nature sounds and earplug interventions are effective in reducing the anxiety of patients following percutaneous coronary intervention.,"['114 patients who were scheduled to undergo percutaneous coronary intervention', 'patients following percutaneous coronary intervention', 'patients after percutaneous coronary interventions']","['nature sounds and earplugs', 'intervention groups (nature sound group, earplug group) and one control group', 'nature sounds and earplug interventions']","['respiratory rates and the Visual Analog Scale and State Anxiety Inventory scores', 'pulse and systolic/diastolic blood pressure values', 'respiratory rates, Visual Analog Scale scores and State Anxiety Inventory scores', 'Visual Analog Scale, State Anxiety Inventory and physiological parameters']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C1262865', 'cui_str': 'Natures (qualifier value)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C1135964', 'cui_str': 'Earplugs'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",114.0,0.0390452,It was determined that nature sounds and earplug interventions are effective in reducing the anxiety of patients following percutaneous coronary intervention.,"[{'ForeName': 'Kamile', 'Initials': 'K', 'LastName': 'Akarsu', 'Affiliation': 'Dışkapı Yıldırım Beyazıt Training and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ayşegül', 'Initials': 'A', 'LastName': 'Koç', 'Affiliation': 'Faculty of Health Sciences, Ankara Yıldırım Beyazıt University, Ankara, Turkey.'}, {'ForeName': 'Nurcan', 'Initials': 'N', 'LastName': 'Ertuğ', 'Affiliation': 'School of Nursing, Ufuk University, Ankara, Turkey.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515119858826']
3213,31100124,Efficacy of Probiotic Prophylaxis After The First Febrile Urinary Tract Infection in Children With Normal Urinary Tracts.,"BACKGROUND


Growing antibiotic resistance and debates over their efficacy for urinary tract infection (UTI) recurrence warrants studying nonantibiotic prophylaxis for preventing UTI recurrences.
METHODS


We randomly assigned 181 children, aged 4 months to 5 years, with a normal urinary tract after recovery from their first febrile UTI in a 1:1 ratio to receive a probiotic mixture of Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum, and Bifidobacterium lactis (n = 91) or placebo (n = 90) for a total of 18 months of therapy. The primary objective was to show the superiority of probiotic prophylaxis to placebo. The primary end point was composite cure (UTI-free survival) at 18 months, and the secondary end point was the median time to first UTI recurrence.
RESULTS


The probiotics were superior to placebo with respect to the primary efficacy end point. At 18 months, composite cure was observed in 96.7% (3 of 91) of the patients in the probiotic group and 83.3% (15 of 90) of those in the placebo group (P = .02). The median time to the first incidence of UTI recurrence was 3.5 months (range, 1-4 months) and 6.5 months (range, 2-14 months) in the probiotic and placebo groups, respectively (P = .04). The main microorganism that caused recurrent UTI was Escherichia coli, followed by Klebsiella pneumoniae, and these results were not significantly different between the 2 groups. We found no specific adverse events among the participants who received the probiotic mixture during the course of therapy.
CONCLUSIONS


The probiotics were more effective than placebo at reducing the risk of recurrent UTI in children with a normal urinary tract after their first episode of febrile UTI.",2020,The probiotics were more effective than placebo at reducing the risk of recurrent UTI in children with a normal urinary tract after their first episode of febrile UTI.,"['Children With Normal Urinary Tracts', '181 children, aged 4 months to 5 years, with a normal urinary tract after recovery from their first febrile UTI in a 1:1 ratio to receive a']","['Probiotic Prophylaxis', 'probiotic mixture', 'placebo', 'probiotic mixture of Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium bifidum, and Bifidobacterium lactis (n = 91) or placebo']","['composite cure (UTI-free survival', 'median time to first UTI recurrence', 'risk of recurrent UTI', 'median time to the first incidence of UTI recurrence', 'composite cure']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0042027'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis subsp. lactis'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0262655', 'cui_str': 'Recurrent urinary tract infection (disorder)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",181.0,0.0976912,The probiotics were more effective than placebo at reducing the risk of recurrent UTI in children with a normal urinary tract after their first episode of febrile UTI.,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sadeghi-Bojd', 'Affiliation': 'Department of Pediatrics, Division of Nephrology, Zahedan University of Medical Sciences, Zahedan, Iran.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Naghshizadian', 'Affiliation': 'Department of Pediatrics, Section of Nephrology, Kurdistan University of Medical Science, Sanandaj, Iran.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mazaheri', 'Affiliation': 'Department of Pediatrics, Section of Nephrology, Semnan University of Medical Science1 Semnan, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ghane Sharbaf', 'Affiliation': 'Department of Pediatrics, Division of Nephrology, Dr Sheikh Hospital, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Assadi', 'Affiliation': 'Department of Pediatrics, Division of Nephrology, Rush University Medical Center, Chicago, Illinois.'}]",Journal of the Pediatric Infectious Diseases Society,['10.1093/jpids/piz025']
3214,31756496,Brigatinib in Crizotinib-Refractory ALK+ NSCLC: 2-Year Follow-up on Systemic and Intracranial Outcomes in the Phase 2 ALTA Trial.,"INTRODUCTION


We report updated data from a phase 2 randomized study evaluating brigatinib in crizotinib-refractory anaplastic lymphoma kinase-positive NSCLC.
METHODS


Patients were randomized 1:1 to take either oral brigatinib 90 mg once daily (arm A) or 180 mg once daily with a 7-day lead-in at 90 mg (arm B), stratified by central nervous system (CNS) metastases and best response to crizotinib. The primary end point was investigator-assessed confirmed objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1. Secondary end points included independent review committee (IRC)-assessed progression-free survival (PFS), intracranial PFS (iPFS), and overall survival (OS). Exploratory analyses included CNS versus ex-CNS target lesion response and correlation of depth of response with PFS and OS.
RESULTS


Among 222 randomized patients (112 and 110 in arms A and B, respectively), 59 (27%) remained on brigatinib at analysis (median follow-up: 19.6 versus 24.3 months). At baseline, 71% and 67% had brain lesions among A and B arms, respectively. Investigator-assessed confirmed objective response rate was 46% versus 56%. Median IRC-assessed PFS was 9.2 months (95% confidence interval: 7.4-12.8) versus 16.7 months (11.6-21.4). Median OS was 29.5 months (18.2-not reached) versus 34.1 months (27.7-not reached). IRC-confirmed intracranial objective response rate in patients with measurable baseline brain lesions was 50% (13 of 26) versus 67% (12 of 18); median duration of intracranial response was 9.4 versus 16.6 months. IRC-assessed iPFS was 12.8 versus 18.4 months. Across arms, median IRC-assessed PFS was 1.9, 5.5, 11.1, 16.7, and 15.6 months for patients with no, 1%-25%, 26%-50%, 51%-75%, and 76%-100% target lesion shrinkage, respectively. No new safety findings were observed with longer follow-up.
CONCLUSIONS


Brigatinib (180 mg once daily with lead-in) continues to demonstrate robust PFS, long iPFS and duration of intracranial response, and high intracranial objective response rate in crizotinib-refractory patients. Depth of response may be an important end point to capture in future targeted therapy trials.",2020,Median OS was 29.5 months (18.2-not reached [NR])/34.1 months (27.7-NR).,"['Patients', 'crizotinib-refractory anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC']","['oral brigatinib 90 mg qd (arm A) or 180 mg qd with 7-day lead', 'Brigatinib in Crizotinib-Refractory ALK', 'Brigatinib']","['median IRC-assessed PFS', 'IRC-assessed iPFS', 'median duration of intracranial response (iDOR', 'brain lesions', 'IRC-confirmed intracranial ORR (iORR', 'investigator-assessed confirmed objective response rate (cORR) per Response Evaluation Criteria', 'review committee (IRC)-assessed progression-free survival (PFS), intracranial PFS (iPFS) and overall survival (OS', 'Median IRC-assessed PFS', 'Median OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0252409', 'cui_str': 'NPM-ALK'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4530659', 'cui_str': 'brigatinib 90 MG [Alunbrig]'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C4287815', 'cui_str': 'brigatinib'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C0221505', 'cui_str': 'Lesion of brain (finding)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",222.0,0.411958,Median OS was 29.5 months (18.2-not reached [NR])/34.1 months (27.7-NR).,"[{'ForeName': 'Rudolf M', 'Initials': 'RM', 'LastName': 'Huber', 'Affiliation': 'Division of Respiratory Medicine and Thoracic Oncology, Department of Medicine V, University Hospital of Munich, Thoracic Oncology Centre Munich, German Centre for Lung Research, Munich, Bavaria, Germany. Electronic address: Huber@med.uni-muenchen.de.'}, {'ForeName': 'Karin H', 'Initials': 'KH', 'LastName': 'Hansen', 'Affiliation': 'Department of Clinical Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares Rodríguez', 'Affiliation': 'Medical Oncology Department, University Hospital ""12 de Octubre,"" Madrid, Spain.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'West', 'Affiliation': 'Thoracic Oncology Program, Swedish Cancer Institute, Seattle, Washington.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Reckamp', 'Affiliation': 'Department of Medical Oncology & Therapeutics Research, City of Hope National Medical Center, Duarte, California.'}, {'ForeName': 'Natasha B', 'Initials': 'NB', 'LastName': 'Leighl', 'Affiliation': 'Department of Medical Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Tiseo', 'Affiliation': 'Medical Oncology Unit, University Hospital of Parma, Parma, Italy.'}, {'ForeName': 'Egbert F', 'Initials': 'EF', 'LastName': 'Smit', 'Affiliation': 'Department of Pulmonary Diseases, VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Scott N', 'Initials': 'SN', 'LastName': 'Gettinger', 'Affiliation': 'Yale Cancer Center, New Haven, Connecticut.'}, {'ForeName': 'Maximilian J', 'Initials': 'MJ', 'LastName': 'Hochmair', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Karl Landsteiner Institute of Lung Research and Pulmonary Oncology, Vienna, Austria.'}, {'ForeName': 'Sang-We', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Corey J', 'Initials': 'CJ', 'LastName': 'Langer', 'Affiliation': 'University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Myung-Ju', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Edward S', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Levine Cancer Institute, Atrium Health, Charlotte, North Carolina.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kerstein', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, Massachusetts.'}, {'ForeName': 'Harry J M', 'Initials': 'HJM', 'LastName': 'Groen', 'Affiliation': 'University of Groningen and University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'D Ross', 'Initials': 'DR', 'LastName': 'Camidge', 'Affiliation': 'University of Colorado Cancer Center, Aurora, Colorado.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.11.004']
3215,31573608,Alendronate Improves Bone Mineral Density in Children and Adolescents Perinatally Infected With Human Immunodeficiency Virus With Low Bone Mineral Density for Age.,"BACKGROUND


Children and adolescents with perinatal human immunodeficiency virus (HIV) infection and with low bone mineral density (BMD) may be at higher risk of osteoporosis and fractures in later life than their uninfected peers. Bisphosphonate therapy has been shown to reduce fractures in adults with osteoporosis, but has not been formally studied in youths living with HIV.
METHODS


Fifty-two children and adolescents (aged 11-24 years) perinatally infected with HIV with low lumbar spine (LS) BMD (Z score < -1.5) were randomized to receive once-weekly alendronate or placebo in a double-blind cross-over study designed to assess the safety and efficacy of 48 and 96 weeks of alendronate in the United States and Brazil. All participants received daily calcium carbonate and vitamin D supplementation and were asked to engage in regular weight-bearing exercise. Safety and efficacy are summarized for the initial 48 weeks of the trial.
RESULTS


Grade 3 or higher abnormal laboratory values, signs, or symptoms developed in 5 of 32 (16%) participants on alendronate and 2 of 18 (11%) on placebo (P > .99). No cases of jaw osteonecrosis, atrial fibrillation, or nonhealing fractures were reported. Mean increases (95% confidence interval) in LS BMD over 48 weeks were significantly larger on alendronate (20% [14%-25%]) than placebo (7% [5%-9%]) (P < .001). Similar improvements were seen for whole body BMD.
CONCLUSIONS


In this small study in children and adolescents perinatally infected with HIV with low LS BMD, 48 weeks of alendronate was well-tolerated, showed no safety concerns, and significantly improved LS and whole body BMD compared to participants on vitamin D/calcium supplementation and exercise alone.
CLINICAL TRIALS REGISTRATION


NCT00921557.",2020,"Mean increases (95% confidence interval) in LS BMD over 48 weeks were significantly larger on alendronate [20% (14%, 25%)] than placebo [7% (5%, 9%), p<0.001].","['Fifty-two PHIV', 'adults with osteoporosis', 'Perinatally HIV-infected (PHIV) children and adolescents with low bone mineral density (BMD', 'perinatally HIV-infected children and adolescents with low bone mineral density for age', '11-<25 years of age with low lumbar spine (LS) BMD (Z-score < -1.5', 'PHIV children and adolescents with low LS BMD']","['Alendronate', 'alendronate or placebo', 'placebo', 'daily calcium carbonate and vitamin D supplementation', 'Bisphosphonate therapy', 'alendronate']","['LS and whole body BMD', 'Safety and efficacy', 'jaw osteonecrosis, atrial fibrillation, or non-healing fractures', 'LS BMD', 'bone mineral density', 'safety and efficacy']","[{'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C4510264', 'cui_str': 'Disphosphonate therapy'}]","[{'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0029445', 'cui_str': 'Osteonecrosis'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",,0.437437,"Mean increases (95% confidence interval) in LS BMD over 48 weeks were significantly larger on alendronate [20% (14%, 25%)] than placebo [7% (5%, 9%), p<0.001].","[{'ForeName': 'Denise L', 'Initials': 'DL', 'LastName': 'Jacobson', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Lindsey', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Gordon', 'Affiliation': ""Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Rohan', 'Initials': 'R', 'LastName': 'Hazra', 'Affiliation': 'Maternal and Pediatric Infectious Diseases Branch, Division of Extramural Research, Department of Health and Human Services, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Spiegel', 'Affiliation': 'Kelly Government Solutions, contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland, USA.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Ferreira', 'Affiliation': 'Department of Pediatrics, Federal University of Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Fabiana R', 'Initials': 'FR', 'LastName': 'Amaral', 'Affiliation': 'Department of Pediatrics, Ribeirão Preto Medical School, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Jesica', 'Initials': 'J', 'LastName': 'Pagano-Therrien', 'Affiliation': 'Graduate School of Nursing, University of Massachusetts, Worcester, Massachusetts, USA.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Gaur', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, Tennessee, USA.""}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'George', 'Affiliation': 'Family Health International 360, Durham, North Carolina, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Benson', 'Affiliation': 'Department of Radiology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Siberry', 'Affiliation': 'Office of HIV/AIDS, US Agency for International Development, Arlington, Virginia, USA; for the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) P1076 Study Team.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz957']
3216,31173921,Physical Therapy Informed by Acceptance and Commitment Therapy (PACT) Versus Usual Care Physical Therapy for Adults With Chronic Low Back Pain: A Randomized Controlled Trial.,"Chronic low back pain (CLBP) is a major cause of global disability and improving management is essential. Acceptance and commitment therapy (ACT) is a promising treatment for chronic pain but has not been modified for physical therapy. This randomized controlled trial (RCT) compared physical therapy informed by ACT (PACT) against standard care physical therapy for patients with CLBP. Patients with CLBP (duration ≥12 weeks, mean 3 years) were recruited from physical therapy clinics in 4 UK public hospitals. The Roland-Morris Disability Questionnaire (RMDQ) at 3 months' post-randomization was the primary outcome. Two hundred forty-eight participants (59% female, mean age = 48) were recruited and 219 (88.3%) completed measures at 3 and/or 12 months' follow-up. At 3 months, PACT participants reported better outcomes for disability (RMDQ mean difference = 1.07, p = .037, 95% CI = -2.08 to -.07, d = .2), Patient Specific Functioning (p = .008), SF12 physical health (p = .032), and treatment credibility (p < .001). At 12 months' follow-up, there were no significant differences between groups. PACT was acceptable to patients and clinicians and feasible to deliver. Physical therapists incorporated psychological principles successfully and treatment was delivered with high (≥80%) fidelity. Our results may inform the management of CLBP, with potential benefits for patients, health care providers, and society. PERSPECTIVE: Psychologically informed physical therapy has great potential but there are challenges in implementation. The training and support included in the PACT trial enabled the intervention to be delivered as planned. This successfully reduced disability in the short but not long term. Findings could inform physical therapists' treatment of CLBP.",2020,"At 3 months, PACT participants reported better outcomes for disability (RMDQ mean difference =1•07, p=0•037, 95%CI -2•08 to -0•07, d=0•2), Patient Specific Functioning (p=0.008), SF12 physical health (p=0.032), and treatment credibility (p<0.001).","['Patients with CLBP (duration ≥12 weeks, mean 3 years) were recruited from physical therapy clinics in four UK public hospitals', ""248 participants (59% female, mean age=48) were recruited and 219 (88•3%) completed measures at 3 and/or 12 months' follow-up"", 'Chronic low back pain (CLBP', 'adults with chronic low back pain', 'patients with CLBP']","['usual care physical therapy', 'PACT', 'physical therapy informed by Acceptance and Commitment Therapy (PACT) against standard care physical therapy', 'Physical therapy informed by Acceptance and Commitment Therapy (PACT', 'Acceptance and Commitment Therapy (ACT']","['Patient Specific Functioning', 'SF12 physical health', 'Roland-Morris Disability Questionnaire (RMDQ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517648', 'cui_str': '219 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",248.0,0.108932,"At 3 months, PACT participants reported better outcomes for disability (RMDQ mean difference =1•07, p=0•037, 95%CI -2•08 to -0•07, d=0•2), Patient Specific Functioning (p=0.008), SF12 physical health (p=0.032), and treatment credibility (p<0.001).","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Godfrey', 'Affiliation': ""Health Psychology Section, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK; Department of Physiotherapy, School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK. Electronic address: emma.l.godfrey@kcl.ac.uk.""}, {'ForeName': 'Vari', 'Initials': 'V', 'LastName': 'Wileman', 'Affiliation': ""Health Psychology Section, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Galea Holmes', 'Affiliation': ""Health Psychology Section, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Lance M', 'Initials': 'LM', 'LastName': 'McCracken', 'Affiliation': ""Health Psychology Section, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Norton', 'Affiliation': ""Health Psychology Section, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Rona', 'Initials': 'R', 'LastName': 'Moss-Morris', 'Affiliation': ""Health Psychology Section, Department of Psychology, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Noonan', 'Affiliation': ""Guy's and St Thomas' Hospital NHS, St Thomas' Hospital, London, UK.""}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Barcellona', 'Affiliation': ""King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Critchley', 'Affiliation': ""Department of Physiotherapy, School of Population Health and Environmental Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.""}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2019.05.012']
3217,31784343,On-demand pre-exposure prophylaxis with tenofovir disoproxil fumarate plus emtricitabine among men who have sex with men with less frequent sexual intercourse: a post-hoc analysis of the ANRS IPERGAY trial.,"BACKGROUND


ANRS IPERGAY found that on-demand pre-exposure prophylaxis (PrEP) with oral tenofovir disoproxil fumarate plus emtricitabine was associated with an 86% relative reduction of HIV-1 incidence compared with placebo among men who have sex with men at high risk of HIV. We aimed to investigate whether on-demand PrEP was similarly effective among individuals with lower exposure to HIV risk.
METHODS


Participants in the ANRS IPERGAY trial were randomly assigned to receive PrEP (fixed-dose combination of 300 mg tenofovir disoproxil fumarate and 200 mg emtricitabine per pill) or placebo. The primary endpoint was the diagnosis of HIV-1 infection. Pill uptake was assessed by counting returned pills at each follow-up and by estimating tenofovir concentration from frozen plasma samples. Participants were interviewed at each visit to assess the pattern of PrEP use. All participants enrolled in the modified intention-to-treat population of the double-blind phase of the ANRS IPERGAY trial were eligible for this post-hoc analysis. We calculated the total follow-up time for periods of less frequent sexual intercourse with high PrEP adherence (15 pills or fewer per month taken systematically or often during sexual intercourse). To estimate the time of HIV acquisition, fourth-generation HIV-1/2 ELISA assays, plasma HIV-1 RNA assays, and western blot analyses were done with use of frozen samples, and the stage of HIV infection was defined according to Fiebig staging. HIV incidence was compared between the two treatment groups among individuals who had less frequent sexual intercourse with high PrEP adherence. The ANRS IPERGAY trial is registered with ClinicalTrials.gov, NCT01473472.
FINDINGS


400 participants who were randomly assigned to receive PrEP (n=199) or placebo (n=201) between Feb 22, 2012, and Oct 17, 2014, were included in this analysis. 270 participants had at least one period of less frequent sexual intercourse with high PrEP adherence during the study, representing 134 person-years of follow-up and 31% of the total study follow-up. During these periods, participants in both groups reported a median of 5·0 (IQR 2·0-10·0) episodes of sexual intercourse per month and used a median of 9·5 (6·0-13·0) pills per month. Six HIV-1 infections were diagnosed in the placebo group (HIV incidence of 9·2 per 100 person-years; 95% CI 3·4-20·1) and none were diagnosed in the tenofovir disoproxil fumarate plus emtricitabine arm (HIV incidence of 0 per 100 person-years; 0-5·4; p=0·013), with a relative reduction of HIV incidence of 100% (95% CI 39-100).
INTERPRETATION


A choice between daily or on-demand PrEP regimens could be offered to men who have sex with men who have less frequent sexual intercourse.
FUNDING


ANRS (France Recherche Nord and Sud Sida-HIV Hépatites), the Canadian HIV Trials Network, Fonds Pierre Bergé (Sidaction), Gilead Sciences, and the Bill & Melinda Gates Foundation.",2020,"Six HIV-1 infections were diagnosed in the placebo group (HIV incidence of 9·2 per 100 person-years; 95% CI 3·4-20·1) and none were diagnosed in the tenofovir disoproxil fumarate plus emtricitabine arm (HIV incidence of 0 per 100 person-years; 0-5·4; p=0·013), with a relative reduction of HIV incidence of 100% (95% CI 39-100).
","['All participants enrolled in the modified intention-to-treat population of the double-blind phase of the ANRS IPERGAY trial were eligible for this post-hoc analysis', 'Participants in the ANRS IPERGAY trial', 'n=201) between Feb 22, 2012, and Oct 17, 2014', '400 participants', 'individuals with lower exposure to HIV risk', '270 participants had at least one period of less frequent sexual intercourse with high PrEP adherence during the study, representing 134 person-years of follow-up and 31% of the total study follow-up', 'men who have sex with men with less frequent sexual intercourse', 'men who have sex with men who have less frequent sexual intercourse', 'men who have sex with men at high risk of HIV']","['PrEP (fixed-dose combination of 300 mg tenofovir disoproxil fumarate and 200 mg emtricitabine per pill) or placebo', 'placebo', 'tenofovir disoproxil fumarate plus emtricitabine', 'oral tenofovir disoproxil fumarate plus emtricitabine', 'PrEP']","['Pill uptake', 'median of 5·0 (IQR 2·0-10·0) episodes of sexual intercourse', 'time of HIV acquisition, fourth-generation HIV-1/2 ELISA assays, plasma HIV-1 RNA assays, and western blot analyses', 'HIV incidence', 'diagnosis of HIV-1 infection']","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0949466', 'cui_str': 'Western Immunoblot'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}]",400.0,0.585594,"Six HIV-1 infections were diagnosed in the placebo group (HIV incidence of 9·2 per 100 person-years; 95% CI 3·4-20·1) and none were diagnosed in the tenofovir disoproxil fumarate plus emtricitabine arm (HIV incidence of 0 per 100 person-years; 0-5·4; p=0·013), with a relative reduction of HIV incidence of 100% (95% CI 39-100).
","[{'ForeName': 'Guillemette', 'Initials': 'G', 'LastName': 'Antoni', 'Affiliation': 'Institut national de la santé et de la recherche médicale (INSERM) SC10 US19, Villejuif, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Tremblay', 'Affiliation': ""Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada.""}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Delaugerre', 'Affiliation': 'Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France; INSERM UMR 944, Biologie Cellulaire des Infections Virales, Paris, France; Université de Paris, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Charreau', 'Affiliation': 'Institut national de la santé et de la recherche médicale (INSERM) SC10 US19, Villejuif, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Cua', 'Affiliation': ""Hôpital de l'Archet, Nice, France.""}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Rojas Castro', 'Affiliation': ""Coalition PLUS, Pantin, France; Aix Marseille University, INSERM, Institut de Recherche pour le Développement, Sciences Economiques & Sociales de la Santé et Traitement de l'Information Médicale, Marseille, France; Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur, Marseille, France.""}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Raffi', 'Affiliation': 'INSERM CIC 1413, Nantes, France; Service des Maladies Infectieuses et Tropicales, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Chas', 'Affiliation': 'Hôpital Tenon, Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Huleux', 'Affiliation': 'Hôpital Gustave Dron, Centre Hospitalier Universitaire de Tourcoing, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Spire', 'Affiliation': ""Aix Marseille University, INSERM, Institut de Recherche pour le Développement, Sciences Economiques & Sociales de la Santé et Traitement de l'Information Médicale, Marseille, France; Observatoire Régional de la Santé Provence-Alpes-Côte d'Azur, Marseille, France.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Capitant', 'Affiliation': 'Institut national de la santé et de la recherche médicale (INSERM) SC10 US19, Villejuif, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Cotte', 'Affiliation': 'Hôpital de la Croix Rousse, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Meyer', 'Affiliation': 'Institut national de la santé et de la recherche médicale (INSERM) SC10 US19, Villejuif, France; Université Paris Sud, Université Paris Saclay, Paris, France. Electronic address: laurence.meyer@inserm.fr.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Molina', 'Affiliation': 'Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, Paris, France; INSERM UMR 944, Biologie Cellulaire des Infections Virales, Paris, France; Université de Paris, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(19)30341-8']
3218,31903494,Evaluating the Effects of a Brief Tobacco Intervention in the U.S. Air Force.,"INTRODUCTION


Military personnel have among the highest rates of tobacco use in the US. Unfortunately, there are few interventions aimed at reducing tobacco use among this vulnerable population. The current study addresses this need by evaluating the short-term effectiveness of a Brief Tobacco Intervention (BTI), a 40-minute group-based intervention designed to reduce contemporary patterns of tobacco use among a sample of US military enlistees during an 11-week period of involuntary tobacco abstinence.
METHODS


Participants were 2,999 US Air Force Technical Trainees at Joint Base San Antonio-Lackland Air Force Base in San Antonio, Texas from April 2017 through January 2018. Participants were cluster randomized to three conditions: (1) BTI + Airman's Guide to Remaining Tobacco Free (AG), (2) AG intervention, or (3) standard smoking cessation intervention. The primary analysis was a comparison of the interventions' efficacies in preventing tobacco use during Technical Training, conducted using a generalized estimating equations logistic regression model controlling for covariates. Multiple imputation was used to account for loss to follow-up.
RESULTS


There was not a significant difference by condition in the use of tobacco products at follow-up (p=0.454). The BTI + AG condition did produce short-term changes in perceived harm, intentions to use tobacco, knowledge about tobacco products, and normative beliefs.
CONCLUSIONS


These findings suggest that while the intervention was effective in the short-term, it was not potent enough over a 12-week period to prevent Airmen from initiating tobacco use. Future studies should examine whether adding a booster session or media campaign enhances the effectiveness of the intervention.",2020,There was not a significant difference by condition in the use of tobacco products at follow-up (p=0.454).,"['Participants were 2,999 US Air Force Technical Trainees at Joint Base San Antonio-Lackland Air Force Base in San Antonio, Texas from April 2017 through January 2018']","['Brief Tobacco Intervention (BTI', 'Brief Tobacco Intervention', ""BTI + Airman's Guide to Remaining Tobacco Free (AG), (2) AG intervention, or (3) standard smoking cessation intervention""]",[],"[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C4521691', 'cui_str': 'US Military enlisted E2'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",[],,0.0315383,There was not a significant difference by condition in the use of tobacco products at follow-up (p=0.454).,"[{'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Little', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Fahey', 'Affiliation': 'University of Memphis, Memphis, TN.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Klesges', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'McMurry', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA.'}, {'ForeName': 'Gerald W', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'University of Virginia School of Medicine, Charlottesville, VA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa001']
3219,30968546,Exercise testing after chronic total coronary occlusion revascularization in patients with STEMI and a concurrent CTO: A subanalysis of the EXPLORE-trial.,"OBJECTIVES


To assess the effect of chronic total occlusion percutaneous coronary intervention (CTO PCI) on ventricular ectopy (VE) and symptomatology during exercise testing.
BACKGROUND


During exercise, the hypoxic myocardium in the CTO-territory can act as a substrate for VE and could lead to anginal complaints.
METHODS


In the EXPLORE-trial, 302 ST-segment elevation myocardial infarction (STEMI)-patients were randomized to CTO PCI or no-CTO PCI. For this sub-study, we analyzed all available exercise electrocardiograms (X-ECGs) at 4 months follow-up on symptoms and electrocardiographic parameters.
RESULTS


A total of 155 X-ECGs were available, 80 in the CTO PCI group (51.6%) and 75 in the no-CTO PCI group (48.4%). There were no differences regarding exercised time, achieved endurance, ST-deviation nor maximum heart-rate. The percentage of patients experiencing chest-pain during exercise was lower in the CTO PCI group (0% vs. 8.5%, p = .03). Also, there was a trend towards a higher maximum systolic blood pressure (SBP, 185 mmHg vs. 175, p = .09). No difference in VE was found between randomization groups, but patients with successful CTO PCI had a higher frequency of VE, compared to failed and no-CTO PCI (26% vs. 8%, p = .02). This did not result in higher frequencies of sustained ventricular arrhythmias or mortality.
CONCLUSION


In conclusion, in STEMI-patients, CTO PCI is associated with a small reduction of chest-pain during exercise and tended to be associated with an increase of maximum SBP. The observation that successful CTO PCI was associated with more VE during exercise, compared with failed/no-CTO PCI needs further exploration.",2019,"No difference in VE was found between randomization groups, but patients with successful CTO PCI had a higher frequency of VE, compared to failed and no-CTO PCI (26% vs. 8%, p = .02).","['patients with STEMI and a concurrent CTO', '302 ST-segment elevation myocardial infarction (STEMI)-patients']","['Exercise testing', 'CTO PCI or no-CTO PCI', 'CTO PCI', 'chronic total occlusion percutaneous coronary intervention (CTO PCI']","['VE', 'percentage of patients experiencing chest-pain during exercise', 'maximum SBP', 'ventricular ectopy (VE) and symptomatology', 'exercised time, achieved endurance, ST-deviation nor maximum heart-rate', 'maximum systolic blood pressure', 'higher frequencies of sustained ventricular arrhythmias or mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0439587', 'cui_str': 'Exercise time (qualifier value)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C1282150', 'cui_str': 'Maximum systolic blood pressure'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",302.0,0.0926531,"No difference in VE was found between randomization groups, but patients with successful CTO PCI had a higher frequency of VE, compared to failed and no-CTO PCI (26% vs. 8%, p = .02).","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'van Veelen', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Heart Center, The Netherlands.'}, {'ForeName': 'Ivo M', 'Initials': 'IM', 'LastName': 'van Dongen', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Heart Center, The Netherlands.'}, {'ForeName': 'Joëlle', 'Initials': 'J', 'LastName': 'Elias', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Heart Center, The Netherlands.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Råmunddal', 'Affiliation': 'Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Erlend', 'Initials': 'E', 'LastName': 'Eriksen', 'Affiliation': 'Department of Cardiology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'René J', 'Initials': 'RJ', 'LastName': 'van der Schaaf', 'Affiliation': 'Department of Cardiology, OLVG Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Bimmer E P M', 'Initials': 'BEPM', 'LastName': 'Claessen', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Heart Center, The Netherlands.'}, {'ForeName': 'Pieter G', 'Initials': 'PG', 'LastName': 'Postema', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Heart Center, The Netherlands.'}, {'ForeName': 'José P S', 'Initials': 'JPS', 'LastName': 'Henriques', 'Affiliation': 'Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Heart Center, The Netherlands.'}]",Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions,['10.1002/ccd.28282']
3220,31942729,Comparison of epidural analgesia combined with general anesthesia and general anesthesia for postoperative cognitive dysfunction in elderly patients.,"BACKGROUND


Cognitive dysfunction in the early postoperative course is common for the elderly population. Anesthetic management may affect postoperative cognitive decline. Effective analgesia, early recovery and modulation of the stress response are advantages of neuraxial blocks. This study aims to compare the effects of general anesthesia and the combination of general anesthesia with epidural analgesia for postoperative cognitive dysfunction (POCD). We hypothesized that neuraxial block combined with general anesthesia (GA) would have a favorable influence on POCD prevention.
METHODS


Patients above 60 years undergoing non-cardiac surgery were included in this randomized, prospective study and randomized into two groups. Patients in the first group (GI) were treated under GA, whereas in the second group (GII), epidural analgesia was combined with GA. Patients' cognitive function was assessed before and one week after surgery using a neuropsychological test battery. POCD was defined as a drop of one standard deviation from baseline on two or more tests.
RESULTS


A total of 116 patients were allocated for the final analysis. Demographic and operative data were similar between groups, except maximum pain scores, which were significantly higher in GI than GII (4.9±2.8 vs. 1.7±1.7; p<0.001, respectively). The incidence of POCD was comparable between groups (26% in GI and 24% in GII). Memory performance, visuospatial functions, and language skills tests were significantly higher in GII compared to GI.
CONCLUSION


General anesthesia and epidural analgesia combined with general anesthesia resulted in similar POCD in elderly patients undergoing abdominal surgery. However, in combined anesthesia group memory, language skills and visuospatial functions appeared to be better preserved. Effective pain control might contribute to preventing cognitive decline in some domains.",2020,"Demographic and operative data were similar between groups, except maximum pain scores, which were significantly higher in GI than GII (4.9±2.8 vs. 1.7±1.7; p<0.001, respectively).","['elderly population', 'elderly patients undergoing abdominal surgery', 'Patients above 60 years undergoing non-cardiac surgery', 'elderly patients', 'A total of 116 patients']","['General anesthesia and epidural analgesia combined with general anesthesia', 'epidural analgesia combined with general anesthesia and general anesthesia', 'epidural analgesia was combined with GA', 'general anesthesia and the combination of general anesthesia with epidural analgesia', 'neuraxial block combined with general anesthesia (GA']","['Memory performance, visuospatial functions, and language skills tests', 'language skills and visuospatial functions', 'postoperative cognitive decline', 'maximum pain scores', 'Demographic and operative data', 'POCD', 'incidence of POCD', 'cognitive function']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}]","[{'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1319002', 'cui_str': 'Neuraxial nerve block'}]","[{'cui': 'C1285654', 'cui_str': 'Ability to remember'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0234985', 'cui_str': 'Cognitive Decline'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}]",116.0,0.0683021,"Demographic and operative data were similar between groups, except maximum pain scores, which were significantly higher in GI than GII (4.9±2.8 vs. 1.7±1.7; p<0.001, respectively).","[{'ForeName': 'Günseli', 'Initials': 'G', 'LastName': 'Orhun', 'Affiliation': 'Department of Anesthesiology and Intensive Care, İstanbul University İstanbul Faculty of Medicine, İstanbul-Turkey.'}, {'ForeName': 'Zerrin', 'Initials': 'Z', 'LastName': 'Sungur', 'Affiliation': 'Department of Anesthesiology and Intensive Care, İstanbul University İstanbul Faculty of Medicine, İstanbul-Turkey.'}, {'ForeName': 'Kemalettin', 'Initials': 'K', 'LastName': 'Koltka', 'Affiliation': 'Department of Anesthesiology and Intensive Care, İstanbul University İstanbul Faculty of Medicine, İstanbul-Turkey.'}, {'ForeName': 'Meltem', 'Initials': 'M', 'LastName': 'Savran Karadeniz', 'Affiliation': 'Department of Anesthesiology and Intensive Care, İstanbul University İstanbul Faculty of Medicine, İstanbul-Turkey.'}, {'ForeName': 'Hacer Ayşe', 'Initials': 'HA', 'LastName': 'Yavru', 'Affiliation': 'Department of Anesthesiology and Intensive Care, İstanbul University İstanbul Faculty of Medicine, İstanbul-Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Gürvit', 'Affiliation': 'Department of Neurology, Behavioral Neurology and Movement Disorders Unit, İstanbul University İstanbul Faculty of Medicine, İstanbul-Turkey.'}, {'ForeName': 'Mert', 'Initials': 'M', 'LastName': 'Şentürk', 'Affiliation': 'Department of Anesthesiology and Intensive Care, İstanbul University İstanbul Faculty of Medicine, İstanbul-Turkey.'}]",Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES,['10.14744/tjtes.2019.04135']
3221,31225625,Potential Moderating Effects of Sex/Gender on the Acute Relative Reinforcing and Subjective Effects of Reduced Nicotine Content Cigarettes in Vulnerable Populations.,"INTRODUCTION


Reports in relatively healthy smokers suggest men are more sensitive than women to the subjective effects of reduced nicotine content cigarettes (RNCCs). We know of no reports examining sex differences in the relative reinforcing effects of RNCCs, an important outcome in assessing smoking's addiction potential. The aim of the present study is to address this gap by examining sex/gender differences on reinforcing effects while examining whether sex differences in subjective effects are discernible in vulnerable populations.
METHODS


Secondary analysis of a within-subject, double-blinded experiment examining acute effects of cigarettes varying in nicotine content (0.4, 2.4, 5.2, 15.8 mg/g) among 169 adult smokers with psychiatric conditions or socioeconomic disadvantage. Effects of dose, sex, and their interaction were examined on reinforcing (concurrent-choice and Cigarette Purchase Task [CPT] testing), and subjective effects (Cigarette Evaluation Questionnaire [CEQ] and craving/withdrawal ratings).
RESULTS


Reducing nicotine content decreased the relative reinforcing effects of smoking in concurrent-choice and CPT testing (p's < .05) with no significant effects of sex nor dose × sex/gender interactions. Reducing nicotine content decreased CEQ ratings with only a single significant effect of sex (higher Psychological Reward scores among women than men, p = .02) and no significant dose × sex/gender interactions. Results on craving/withdrawal paralleled those on the CEQ.
CONCLUSIONS


Reducing nicotine content decreases the addiction potential of smoking independent of sex in populations highly vulnerable to smoking and addiction, with no indication that women are less sensitive to subjective effects of RNCCs or would benefit less from a policy reducing the nicotine content of cigarettes.
IMPLICATIONS


A policy reducing the nicotine content of cigarettes has the potential to reduce the addiction potential of smoking across men and women who are especially vulnerable to smoking, addiction, and tobacco-related adverse health impacts.",2020,"RESULTS


Reducing nicotine content decreased the relative reinforcing effects of smoking in concurrent-choice and CPT testing (p's < .05) with no significant effects of sex nor dose-by-sex/gender interactions.","['Vulnerable Populations', 'healthy smokers suggest men', 'Secondary analysis of a within-subject, double-blind experiment examining acute effects of cigarettes varying in nicotine content (0.4, 2.4, 5.2, 15.8 mg/g) among 169 adult smokers with psychiatric conditions or socioeconomic disadvantage']",['Nicotine Content Cigarettes'],"['CEQ ratings', 'reinforcing (concurrent-choice and Cigarette Purchase Task (CPT) testing), and subjective effects (Cigarette Evaluation Questionnaire (CEQ) and craving/withdrawal ratings']","[{'cui': 'C0949366', 'cui_str': 'Vulnerable Populations'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0870371', 'cui_str': 'Craving'}]",169.0,0.0258027,"RESULTS


Reducing nicotine content decreased the relative reinforcing effects of smoking in concurrent-choice and CPT testing (p's < .05) with no significant effects of sex nor dose-by-sex/gender interactions.","[{'ForeName': 'Joanna M', 'Initials': 'JM', 'LastName': 'Streck', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Danielle R', 'Initials': 'DR', 'LastName': 'Davis', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Raina D', 'Initials': 'RD', 'LastName': 'Pang', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA.'}, {'ForeName': 'Stacey C', 'Initials': 'SC', 'LastName': 'Sigmon', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Janice Y', 'Initials': 'JY', 'LastName': 'Bunn', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Cecilia L', 'Initials': 'CL', 'LastName': 'Bergeria', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University, Providence, RI.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Heil', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Diann E', 'Initials': 'DE', 'LastName': 'Gaalema', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hughes', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Maxine L', 'Initials': 'ML', 'LastName': 'Stitzer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Ellaina', 'Initials': 'E', 'LastName': 'Reed', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'Vermont Center on Tobacco Regulatory Science, Departments of Psychiatry and Psychological Science, University of Vermont,Burlington, VT.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntz098']
3222,31838056,Consumer responses to framing statements preceding the major risk statement in prescription drug DTC TV ads.,"BACKGROUND


Research on the major risk statement in direct-to-consumer (DTC) prescription drug television ads has shown that risk severity and actionability can affect consumers' risk comprehension and perceptions. A framing statement presented just before the major risk statement may serve as a cue that directs attention to the risk statement that follows, or it may guide consumers' interpretation of the severity of the risks that follow.
OBJECTIVE


Examine how the use of different framing statements (severe, life-threatening; serious; or basic) that precede the major risk statement in DTC television ads affect consumers' risk perceptions, risk recognition, benefit perceptions, interest in the drug, and other relevant outcomes.
METHODS


An online experiment was conducted using a 1 × 3 between-subjects design to compare three different framing statements, which was replicated across three different DTC television ads that focused on different medical conditions (arthritis, lung cancer, and type 2 diabetes). A sample of US adults (N = 1961) was randomly assigned to view one of nine television ads and asked to respond to a questionnaire.
RESULTS


The type of framing statement had significant effects on perceived risk severity, perceived utility of risk and benefit information, fear of risks, and perceived likelihood of explicit and implicit benefits.
CONCLUSIONS


Consumers pay attention to and use cues to process and interpret the risk information presented to them in DTC television ads. Using lead-in language that describes risk severity, particularly for products with severe, life-threatening risks, may better allow consumers to make evaluative judgments on risk severity in DTC ads than stating the drug can cause serious reactions or simply that reactions are possible. More work is needed to examine the factors that affect people's understanding of the nature of risk severity, particularly with regard to risk recognition.",2020,"The type of framing statement had significant effects on perceived risk severity, perceived utility of risk and benefit information, fear of risks, and perceived likelihood of explicit and implicit benefits.
",['A sample of US adults (N\xa0=\xa01961'],['nine television ads and asked to respond to a questionnaire'],"['perceived risk severity, perceived utility of risk and benefit information, fear of risks, and perceived likelihood of explicit and implicit benefits']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0687742', 'cui_str': 'Risks and Benefits'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",,0.0265402,"The type of framing statement had significant effects on perceived risk severity, perceived utility of risk and benefit information, fear of risks, and perceived likelihood of explicit and implicit benefits.
","[{'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Aikin', 'Affiliation': 'US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 10903 New Hampshire Ave., Silver Spring, MD, 20993, USA. Electronic address: kathryn.aikin@fda.hhs.gov.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Betts', 'Affiliation': 'US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Prescription Drug Promotion, 10903 New Hampshire Ave., Silver Spring, MD, 20993, USA. Electronic address: kevin.betts@fda.hhs.gov.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Boudewyns', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, P.O. Box 12194, Research Triangle Park, NC, 27709, USA. Electronic address: vboudewyns@rti.org.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Johnson', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, P.O. Box 12194, Research Triangle Park, NC, 27709, USA. Electronic address: mjohnson@rti.org.'}, {'ForeName': 'Christine N', 'Initials': 'CN', 'LastName': 'Davis', 'Affiliation': 'RTI International, 3040 E. Cornwallis Road, P.O. Box 12194, Research Triangle Park, NC, 27709, USA. Electronic address: cdavis@rti.org.'}]",Research in social & administrative pharmacy : RSAP,['10.1016/j.sapharm.2019.11.018']
3223,30194031,"ODM-204, a Novel Dual Inhibitor of CYP17A1 and Androgen Receptor: Early Results from Phase I Dose Escalation in Men with Castration-resistant Prostate Cancer.","BACKGROUND


Most prostate cancer patients develop castration-resistant prostate cancer (CRPC) after androgen deprivation therapy treatment. CRPC growth is mediated mostly by androgen receptor signalling driven by primary androgens synthesised largely by the CYP17A1 enzyme.
OBJECTIVE


To evaluate the safety profile and dose-limiting toxicities of ODM-204.
DESIGN, SETTING, AND PARTICIPANTS


In this open, uncontrolled, nonrandomised, multicentre, tolerability and pharmacokinetic first-in-man phase I dose escalation study, patients with metastatic CRPC were randomised to receive ODM-204 in sequential cohorts of five dose levels (ie, 50, 100, 200, 300, and 500mg twice daily) concomitantly with prednisone.
INTERVENTION


ODM-204, a novel, orally administered, investigational, nonsteroidal dual inhibitor of CYP17A1 and androgen receptor.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS


ODM-204 plasma concentrations, serum testosterone, and prostate-specific antigen (PSA) levels were evaluated and imaging of lesions was performed.
RESULTS AND LIMITATIONS


Of the 23 patients enrolled into the study, 60.9% experienced mild adverse effects considered to be related to the study treatment, which were fatigue, increased/decreased appetite, nausea, asthenia, diarrhoea, and weight decrease. ODM-204 area under the curve (AUC 0-12 ) values increased dose dependently until the 300mg dose. The AUC was lower on day 8 after repeated dosing compared with day 1 from the 200mg dose upwards. Decreases in testosterone levels were seen with ODM-204 treatment confirming androgen deprivation. Of the patients, 13% also demonstrated a >50% decrease in PSA at week 12 and continued ODM-204 treatment for over a year.
CONCLUSIONS


ODM-204 was well tolerated up to the highest evaluated dose. There were decreases in both testosterone and PSA levels, suggesting preliminary antitumour activity in the treatment of CRPC. The pharmacokinetic properties of the molecule, however, prevent further development.
PATIENT SUMMARY


This study looked at the safety of ODM-204, a novel dual inhibitor of CYP17A1 and the androgen receptor, in castration-resistant prostate cancer patients. ODM-204 treatment was found to be well tolerated, and it also reduced both serum testosterone and prostate-specific antigen levels, but the properties of the molecule prevent further development.",2020,"ODM-204 treatment was found to be well tolerated, and it also reduced both serum testosterone and prostate-specific antigen levels, but the properties of the molecule prevent further development.","['Men with Castration-resistant Prostate Cancer', 'castration-resistant prostate cancer patients', 'prostate cancer patients develop castration-resistant prostate cancer (CRPC) after androgen deprivation therapy treatment', 'patients with metastatic CRPC', 'Of the 23 patients enrolled into the study, 60.9% experienced']","['ODM-204', 'CYP17A1 and Androgen Receptor', 'prednisone']","['mild adverse effects', 'testosterone levels', 'PSA', 'serum testosterone and prostate-specific antigen levels', 'ODM-204 area under the curve (AUC 0-12 ) values', 'appetite, nausea, asthenia, diarrhoea, and weight decrease', 'plasma concentrations, serum testosterone, and prostate-specific antigen (PSA) levels', 'testosterone and PSA levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0034786', 'cui_str': 'Testosterone Receptor'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",23.0,0.0423612,"ODM-204 treatment was found to be well tolerated, and it also reduced both serum testosterone and prostate-specific antigen levels, but the properties of the molecule prevent further development.","[{'ForeName': 'Katriina J', 'Initials': 'KJ', 'LastName': 'Peltola', 'Affiliation': 'Helsinki University Hospital, Comprehensive Cancer Centre, Helsinki, Finland.'}, {'ForeName': 'Petri', 'Initials': 'P', 'LastName': 'Bono', 'Affiliation': 'Helsinki University Hospital, Comprehensive Cancer Centre, Helsinki, Finland.'}, {'ForeName': 'Robert Hugh', 'Initials': 'RH', 'LastName': 'Jones', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Egils', 'Initials': 'E', 'LastName': 'Vjaters', 'Affiliation': 'P. Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'Pirjo', 'Initials': 'P', 'LastName': 'Nykänen', 'Affiliation': 'Orion Corporation Orion Pharma, Espoo, Finland.'}, {'ForeName': 'Annamari', 'Initials': 'A', 'LastName': 'Vuorela', 'Affiliation': 'Orion Corporation Orion Pharma, Espoo, Finland.'}, {'ForeName': 'Riikka', 'Initials': 'R', 'LastName': 'Oksala', 'Affiliation': 'Orion Corporation Orion Pharma, Espoo, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Pohjanjousi', 'Affiliation': 'Orion Corporation Orion Pharma, Espoo, Finland.'}, {'ForeName': 'Mika V J', 'Initials': 'MVJ', 'LastName': 'Mustonen', 'Affiliation': 'Orion Corporation Orion Pharma, Espoo, Finland. Electronic address: mika.mustonen@orionpharma.com.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Institut Gustave-Roussy, University of Paris Sud, Villejuif, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Massard', 'Affiliation': 'Drug Development Department (DITEP), Inserm Unit U981, Université Paris Saclay, Université Paris-Sud, Gustave Roussy, Villejuif, France.'}]",European urology focus,['10.1016/j.euf.2018.08.022']
3224,31823379,Can I join in? Multiple case study investigation of play performance generalisation for children with autism spectrum disorder from dyad to triad.,"INTRODUCTION


Children with autism spectrum disorder (ASD) have difficulties with play, social interaction with peers and generalisation of intervention outcomes. The Ultimate Guide to Play, Language and Friendship (PLF) has demonstrated effectiveness in improving play performance of children with ASD and their typically developing (TD) peers. The aim of this investigation was to examine the changes in play performance when an additional TD child is added to an existing dyad of a child with ASD and a TD playmate to inform future delivery and adaptations of the intervention.
METHODS


Participants in this multiple case study design were five children with ASD and their TD peer who completed a dyad intervention as part of a randomised control trial investigation of the PLF and an additional TD peer who joined the play dyad. A trained occupational therapist delivered an adapted version of the PLF to the triad over four clinic sessions. An independent rater scored each child (N = 15) on The Test of Playfulness at pre- and post-triad intervention. Line graphs were used to examine case data and compare to dyad play performance and patterns of interaction.
RESULTS


Four of the five children with ASD generalised their play performance from the dyad to the triad social environment. However, the triad intervention did not demonstrate improvements in play performance. The play performance scores for the children with ASD and their TD peers were variable and demonstrated changes in their play pattern from the dyad to the triad.
CONCLUSION


This investigation delivered preliminary evidence of play performance generalisation from a dyad to a triad with TD peers for children with ASD. Careful consideration of characteristics of all playmates is recommended for delivering the intervention to support play performance of children with ASD.",2020,"The Ultimate Guide to Play, Language and Friendship (PLF) has demonstrated effectiveness in improving play performance of children with ASD and their typically developing (TD) peers.","['Participants in this multiple case study design were five children with ASD and their TD peer who completed a dyad intervention as part of a randomised control trial investigation of the PLF and an additional TD peer who joined the play dyad', 'children with ASD', 'children with ASD and their TD peers', 'Children with autism spectrum disorder (ASD', 'children with autism spectrum disorder from dyad to triad', 'children with ASD and their typically developing (TD) peers']","['Language and Friendship (PLF', 'play performance generalisation']","['play performance', 'play performance scores']","[{'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0085973', 'cui_str': 'Case Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0178647', 'cui_str': 'Friendship'}, {'cui': 'C0032214', 'cui_str': 'Play'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0356023,"The Ultimate Guide to Play, Language and Friendship (PLF) has demonstrated effectiveness in improving play performance of children with ASD and their typically developing (TD) peers.","[{'ForeName': 'Cally', 'Initials': 'C', 'LastName': 'Kent', 'Affiliation': 'School of Occupational Therapy and Social Work, Curtin University, Perth, WA, USA.'}, {'ForeName': 'Reinie', 'Initials': 'R', 'LastName': 'Cordier', 'Affiliation': 'School of Occupational Therapy and Social Work, Curtin University, Perth, WA, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Joosten', 'Affiliation': 'School of Allied Health, Australian Catholic University, Melbourne, Vic., Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Wilkes-Gillan', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Bundy', 'Affiliation': 'Department of Occupational Therapy, Colorado State University, Fort Collins, CO, USA.'}]",Australian occupational therapy journal,['10.1111/1440-1630.12635']
3225,31127755,The efficiency of platelet-rich plasma treatment in patients with knee osteoarthritis.,"OBJECTIVE


The aim of this study was to determine the effects of platelet-rich plasma (PRP) treatment on pain, functionality, quality of life, and cartilage thickness in patients with knee osteoarthritis (OA).
METHODS


Sixty patients with chronic knee pain were randomly separated into two groups. The first group was administered 4-ml PRP intra-articularly (IA) in three doses at one-week intervals, and the second group had only one dose of a 4-ml saline solution IA. The patients' pain was measured using the Visual Analogue Scale (VAS); functionality was measured using the Western Ontario and McMaster University Osteoarthritis Index (WOMAC). The distal femur cartilage thickness was assessed using ultrasonography (USG).
RESULTS


All baseline parameters were similar (p> 0.05). In the first and sixth months after the treatment, the VAS scores of the PRP group were significantly low (p< 0.001). In the same group, only the pain sub-score was low in the WOMAC assessment in the first month after treatment. However, in the sixth month, all parameters of the WOMAC score were lower than those of the placebo group (p< 0.05). Cartilage thickness measurements were similar in the two groups (p< 0.05).
CONCLUSION


PRP treatment had positive effects on the pain, physical function, and quality of life of patients with knee OA, but it did not increase cartilage thickness.",2020,"Cartilage thickness measurements were similar in the two groups (p< 0.05).
","['patients with knee osteoarthritis', 'Sixty patients with chronic knee pain', 'patients with knee osteoarthritis (OA']","['placebo', '4-ml PRP intra-articularly (IA', 'PRP', '4-ml saline solution IA', 'platelet-rich plasma (PRP']","['cartilage thickness', 'pain sub-score', 'Cartilage thickness measurements', 'pain, physical function, and quality of life', 'Western Ontario and McMaster University Osteoarthritis Index (WOMAC', 'distal femur cartilage thickness', 'WOMAC score', 'pain, functionality, quality of life, and cartilage thickness', 'Visual Analogue Scale (VAS); functionality', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0242848', 'cui_str': 'PrP (GSS)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}]","[{'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",60.0,0.0211128,"Cartilage thickness measurements were similar in the two groups (p< 0.05).
","[{'ForeName': 'Hüseyin', 'Initials': 'H', 'LastName': 'Elik', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Hamidiye Şişli Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Beril', 'Initials': 'B', 'LastName': 'Doğu', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Hamidiye Şişli Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Figen', 'Initials': 'F', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Hamidiye Şişli Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Feyza Akan', 'Initials': 'FA', 'LastName': 'Begoğlu', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Hamidiye Şişli Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Kuran', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, Hamidiye Şişli Etfal Training and Research Hospital, Istanbul, Turkey.'}]",Journal of back and musculoskeletal rehabilitation,['10.3233/BMR-181374']
3226,31301164,Attachment and compassion-threat: Influence of a secure attachment-prime.,"OBJECTIVES


The present paper proposed and tested a methodology for reducing individual's threat response to compassion-imagery, by increasing their levels of state attachment-security.
DESIGN


A total of 68 University students (63% female, mean age = 25) completed an experimental study, where they were randomly assigned to either a 10-min attachment-prime (to enhance attachment-security) or an interpersonal skills module (control condition).
METHODS


Participants completed a compassion-focused imagery exercise before and after the manipulation, to determine the effects of the attachment-prime. To measure the effects of the manipulation on individual's threat response, heart rate variability data were collected at baseline and during both compassion exercises.
RESULTS


As predicted, individuals who reported higher levels of anxious and avoidant attachment styles were more likely to display a threat response (decreases in heart rate variability), to the first compassion-focused imagery. After receiving an attachment-prime, heart rate variability increased suggesting that individual's experienced greater self-soothing responses and decreased threat responses to the second compassion-focused imagery.
CONCLUSIONS


The present findings suggest that individuals with insecure attachments are likely to require additional support increasing their attachment-security, before they can successfully engage in compassion-based exercises or therapies.
PRACTITIONER POINTS


Compassion-based exercises may result in fear and consequently avoidance in some populations of individuals. Threat responses to compassion can be reduced by using attachment-based techniques. Research findings will help inform and broaden the clinical applicability of compassion-based therapies.",2020,"After receiving an attachment-prime, heart rate variability increased suggesting that individual's experienced greater self-soothing responses and decreased threat responses to the second compassion-focused imagery.
","['Participants completed a', '68 University students (63% female, mean age\xa0=\xa025) completed an experimental study']","['compassion-focused imagery exercise', '10-min attachment-prime (to enhance attachment-security) or an interpersonal skills module (control condition', 'secure attachment-prime']","['heart rate variability', 'levels of anxious and avoidant attachment styles', 'Attachment and compassion-threat']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0679005', 'cui_str': 'Interpersonal Skills'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0582757', 'cui_str': 'Secure attachment (finding)'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}]",68.0,0.035741,"After receiving an attachment-prime, heart rate variability increased suggesting that individual's experienced greater self-soothing responses and decreased threat responses to the second compassion-focused imagery.
","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Baldwin', 'Affiliation': 'School of Applied Psychology, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Bandarian-Balooch', 'Affiliation': 'School of Applied Psychology, Griffith University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'School of Applied Psychology, Griffith University, Gold Coast, Queensland, Australia.'}]",Psychology and psychotherapy,['10.1111/papt.12244']
3227,31972667,Antidepressant Effect of Adjunct Repetitive Transcranial Magnetic Stimulation in Inpatients 60 Years and Older.,"BACKGROUND


Repetitive transcranial magnetic stimulation (rTMS) is now an established, safe, and effective treatment for adults with depression. However, specific research in rTMS for use in elderly patients with acute depression is scarce.
OBJECTIVE


The aim of the present study was to investigate the efficacy of add-on rTMS in a clinical sample of older adults experiencing an acute phase of depression.
METHOD


This study examined 114 patients (54 elderly [aged ≥60] and 60 adults [aged 18-59]) with acute depression who were drug free at baseline. They were treated with at least 10 sessions of rTMS for 4 weeks along with 1 antidepressant. Symptoms of depression were measured using the Hamilton Rating Scale for Depression at baseline and after 2 and 4 weeks of treatment. Clinical improvement and rates of response and remission were compared across groups.
RESULTS


Significant improvement was noted after 2 and 4 weeks of treatment in both adult and elderly groups. Higher remission rates were found in adult patients but with no differences in response. The stimulation intensity and course of illness were significant predictors of remission after 4 weeks of rTMS treatment in the elderly.
CONCLUSIONS


The add-on rTMS treatment for elderly depression patients is promising with respect to safety and feasibility. This preliminary evidence supports the application of rTMS to this group during acute episodes.",2020,"The stimulation intensity and course of illness were significant predictors of remission after 4 weeks of rTMS treatment in the elderly.
","['114 patients (54 elderly [aged ≥60] and 60 adults [aged 18-59]) with acute depression who were drug free at baseline', 'Inpatients 60 Years and Older', 'older adults experiencing an acute phase of depression', 'elderly depression patients', 'adults with depression', 'elderly patients with acute depression']","['Repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'Adjunct Repetitive Transcranial Magnetic Stimulation']","['Symptoms of depression', 'Hamilton Rating Scale for Depression', 'stimulation intensity and course of illness', 'Clinical improvement and rates of response and remission', 'Higher remission rates']","[{'cui': 'C4708785', 'cui_str': 'One hundred and fourteen'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1386135', 'cui_str': 'Acute depression'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439557', 'cui_str': 'Acute phase (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",114.0,0.036166,"The stimulation intensity and course of illness were significant predictors of remission after 4 weeks of rTMS treatment in the elderly.
","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Qiao', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'JunJie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Mental Health, Suzhou Guangji Hospital, The Affiliated Guangji Hospital of Soochow University, Soochow University, Suzhou, Jiangsu.'}, {'ForeName': 'JunJuan', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'HuiRu', 'Initials': 'H', 'LastName': 'Cui', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'YingYing', 'Initials': 'Y', 'LastName': 'Tang', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'LiHua', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'XiaoChen', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'YanYan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Hui', 'Affiliation': 'Institute of Mental Health, Suzhou Guangji Hospital, The Affiliated Guangji Hospital of Soochow University, Soochow University, Suzhou, Jiangsu.'}, {'ForeName': 'ChunBo', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'QiuFang', 'Initials': 'Q', 'LastName': 'Jia', 'Affiliation': 'Institute of Mental Health, Suzhou Guangji Hospital, The Affiliated Guangji Hospital of Soochow University, Soochow University, Suzhou, Jiangsu.'}, {'ForeName': 'HongLiang', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Institute of Mental Health, Suzhou Guangji Hospital, The Affiliated Guangji Hospital of Soochow University, Soochow University, Suzhou, Jiangsu.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wen', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'JiJun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}, {'ForeName': 'TianHong', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'From the Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Key Laboratory of Psychotic Disorders, Shanghai.'}]",The journal of ECT,['10.1097/YCT.0000000000000648']